HUMAN TISSUE SAMPLES: 

NIH RESEARCH POLICIES 

AND PRACTICES 

HEARINGS 

BEFORE THE 

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE 

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED NINTH CONGRESS 

SECOND SESSION 

JUNE 13 AND JUNE 14, 2006 

Serial No. 109-119 

Printed for the use of the Committee on Energy and Commerce 

Available via the World Wide Web: http://www.access.gpo.gov/congress/house 

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WASHINGTON : 2006 

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30-412PDF 
COMMITTEE ON ENERGY AND COMMERCE 

JOE BARTON, Texas, Chairman 

RALPH M. HALL, Texas 

MICHAEL BILIRAKIS, Florida 

 Vice Chairman 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

PAUL E. GILLMOR, Ohio 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

CHARLIE NORWOOD, Georgia 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. “CHIP” PICKERING, Mississippi 

 Vice Chairman

VITO FOSSELLA, New York 

ROY BLUNT, Missouri

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

CHARLES F. BASS, New Hampshire 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

C.L. “BUTCH” OTTER, Idaho 

SUE MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOHN D. DINGELL, Michigan 

 Ranking Member 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

SHERROD BROWN, Ohio 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

ALBERT R. WYNN, Maryland 

GENE GREEN, Texas 

TED STRICKLAND, Ohio 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

TOM ALLEN, Maine 

JIM DAVIS, Florida 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

BUD ALBRIGHT, Staff Director 

DAVID CAVICKE, General Counsel

REID P. F. STUNTZ, Minority Staff Director and Chief Counsel

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

ED WHITFIELD, Kentucky, Chairman 

CLIFF STEARNS, Florida 

CHARLES W. “CHIP” PICKERING, Mississippi 

CHARLES F. BASS, New Hampshire 

GREG WALDEN, Oregon 

MIKE FERGUSON, New Jersey 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas 

 (EX OFFICIO)

BART STUPAK, Michigan 

 Ranking Member 

DIANA DEGETTE, Colorado 

JAN SCHAKOWSKY, Illinois 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

HENRY A. WAXMAN, California 

JOHN D. DINGELL, Michigan 

 (EX OFFICIO)

(II)
CONTENTS 

Page 

Hearings held: 

June 13, 2006...................................................................................................................... 1 

June 14, 2006....................................................................................................................... 205 

Testimony of: 

Molchan, M.D., Susan, Program Director, AD Neuroimaging Initiative, Neuroscience 

and Neuropsychology of Aging Program, National Institute on Aging, National 

Institutes of Health, U.S. Department of Health and Human Services ........................ 167 

Insel, M.D., Thomas R., Director, National Institute of Mental Health, National 

Institutes of Health, U.S. Department of Health and Human Services ......................... 208 

Friedman, Ph.D., David L. ................................................................................................. 212 

Gottesman, M.D., Michael M., Deputy Director of Intramural Research, National 

Institutes of Health, U.S. Department of Health and Human Services ........................ 257 

Additional material submitted for the record: 

Insel, M.D., Thomas R., Director, National Institute of Mental Health, National 

Institutes of Health, U.S. Department of Health and Human Services, response for 

the record........................................................................................................................ 276 

Fitzsimmons, William, Executive Officer, National Institute of Mental Health, 

National Institutes of Health, U.S. Department of Health and Human Services, 

response for the record ................................................................................................... 279 

Gottesman, M.D., Michael M., Deputy Director of Intramural Research, National 

Institutes of Health, U.S. Department of Health and Human Services, response for 

the record........................................................................................................................ 284 

Friedman, Ph.D., David L, response for the record ............................................................ 288 

(III) 

(1) 

HUMAN TISSUE SAMPLES: NIH 

RESEARCH POLICIES AND PRACTICES 

TUESDAY, JUNE 13, 2006 

HOUSE OF REPRESENTATIVES, 

COMMITTEE ON ENERGY AND COMMERCE, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

Washington, DC. 

The subcommittee met, pursuant to notice, at 2:04 p.m., in Room 

2123 of the Rayburn House Office Building, Hon. Ed Whitfield 

(Chairman) presiding. 

 Members present: Representatives Stearns, Walden, Burgess, 

Blackburn, Barton (ex officio), Stupak, Baldwin, and Whitfield. 

 Staff present: Mark Paoletta, Chief Counsel for Oversight and 

Investigations; Alan Slobodin, Deputy Chief Counsel for Oversight and 

Investigations; Mike Abraham, Legislative Clerk, Ryan Ambrose, 

Legislative Clerk; John Ford, Minority Counsel; Jessica McNiece, 

Minority Research Assistant; and William Garner, Minority Professional 

Staff Member. 

 MR. WHITFIELD. I would like to call this hearing to order this 

afternoon. Today and tomorrow, the subcommittee examines the 

important issue of human tissue samples. These samples, such as blood, 

cells, and spinal fluid are raw material of biomedical research that can 

help improve our healthcare. These samples matter because of their 

growing importance in biomedical research. Detailed genetic and other 

biological marker information can be derived from these samples and 

with such information, we can dramatically improve the way we 

diagnose and treat disease. 

 The National Institutes of Health is at the forefront in collecting 

these samples and using them for unique medical research not conducted 

in universities or industrial labs. NIH scientists obtain these samples 

through a great deal of care and work with patients and healthy 

volunteers who participate in biomedical experiments. 

 The ability of NIH researchers to obtain samples from people and the 

resources and the freedom to research relies on a basic trust. These 

hearings focus on whether that trust used to obtain human samples for 

research at NIH is working as well as it should. 

 We look at this important question through the prism of a case study. 

The study involves Dr. Trey Sunderland of the National Institute of 

Mental Health, and the vials of human spinal fluid and plasma he 
2

shipped to Pfizer from 1998 to 2004. Some members of the 

subcommittee may recall Dr. Sunderland’s name from the 

subcommittee’s June 2004 hearing, where we revealed the discrepancies 

between information provided by Pfizer documenting over $500,000 in 

outside consulting payments to Dr. Sunderland over a 5-year period, and 

the information that was given to NIH and to the committee showing no 

documentation of disclosure or approval of these very same outside 

consulting activities for Dr. Sunderland. NIH has investigated these 

discrepancies and made its determination of multiple violations of legal 

and ethical requirements. 

 But today’s inquiry is about an investigation beyond those 

compliance issues. We are concerned primarily about the integrity of 

NIH research. The committee’s concerns in this area were prompted in 

part by Dr. Susan Molchan, who is the Program Director for Alzheimer’s 

disease research at the National Institute of Aging. From 1993 to 1995, 

she conducted a small clinical trial involving the collection of spinal 

fluid from about 25 people, some patients with Alzheimer’s disease and 

some normal volunteers, and used lithium as a probe for potential 

biomarkers of Alzheimer’s disease in spinal fluid and blood. She had 

published two papers and told the committee staff that she had used, at 

the very most, 20 percent of the spinal fluid collected. The unused spinal 

fluid remains stored in freezers at NIMH geriatric/psychiatric branch. 

The chief of the geriatric/psychiatric branch, Dr. Trey Sutherland, 

assumed control of the spinal fluid and the samples after Dr. Molchan 

left. 

 In the fall of 2004, Dr. Molchan was at the NIA and was trying to 

assist an outside researcher in getting unused samples from Dr. 

Molchan’s unfinished study. Ultimately by March of 2005, she learned 

that Dr. Sunderland was only able to produce a very small percent of the 

unused spinal fluid that remained from her lithium study, and that the 

clinical data from that study had been purged. She was concerned about 

what happened to the more than 95 percent of the unused spinal fluid 

samples left in the freezer and to the data. 

 She pursued her concerns for several weeks during 2005 through 

various NIH channels and with the Office of Inspector General, 

Department of Health and Human Services as well. In April 2005, she 

contacted staff with the Committee on Energy and Commerce. After 

more preliminary work from the committee staff, the bipartisan 

leadership of the committee and the subcommittee started a broad 

investigation on the issue of human tissue samples at the National 

Institutes of Health and the particular case involving Dr. Sunderland and 

the spinal fluid samples. 
3

 The committee has been investigating this issue for over a year now. 

We have requested records and information. After reviewing the records 

and interviewing people, the committee staff assembled evidence in its 

report for the subcommittee members. The report, which will be placed 

in the hearing record, raises some very troubling questions. 

 Dr. Sunderland is a leading researcher in the area of Alzheimer’s 

disease. For years, he has been interested in finding a diagnostic test for 

this disease. Pfizer was also interested in this goal, and this joint interest 

was worthy of a scientific collaboration between government and the 

private sector. In 1998, Dr. Sunderland had an opportunity to pursue this 

project legitimately with Pfizer and a British biotechnology firm under 

existing laws and policies that promote this public/private partnership. 

 Instead, disappointingly, the evidence shows that Dr. Sunderland 

used his public office to provide spinal fluid and plasma samples to 

Pfizer at the same time that he engaged in personal consulting with Pfizer 

about these very same samples. He did not disclose these consulting 

arrangements to NIH; this subcommittee exposed them. And even after 

he was under investigation, the records show that Dr. Sunderland did not 

accurately describe the nature of his consulting activities with Pfizer. 

According to the records obtained by the committee, Dr. Sunderland 

provided over 3,000 spinal fluid and plasma samples to Pfizer and 

received $285,000 from Pfizer for two different projects using these 

samples. 

 Congress and NIH have provided the proper mechanisms for 

government/industry partnership and we encourage it. Federal laws and 

policies do not permit, however, NIH scientists to profit personally from 

their jobs and their patients by providing irreplaceable government 

assets. Unfortunately, the evidence before us shows Dr. Sunderland 

operated outside that system. Why did he choose to enrich himself? 

There were mechanisms available to get the resources for his lab as part 

of this collaboration, but there are not records that we have been able to 

find or information showing that this was done, and why not? 

 There were mechanisms available to him and NIH scientists to 

obtain patents and royalties. Dr. Sunderland, however, assigned his 

patent rights to Pfizer under one of the two research projects and he was 

listed as a co-inventor at his home address. Why didn’t he tell NIH? 

Why didn’t he protect the rights of NIH? And what about the 

Alzheimer’s disease patients and human volunteers who had their spines 

punctured and then had to lie on their sides for three hours after each 

procedure? Did Dr. Sunderland tell them he was going to make money 

from their spinal fluid, and why did he make a statement and reaffirm to 

NIH investigators that his outside activities were with one part of Pfizer 

and that the material transfer agreement, his official activities in 
4

providing the samples were with another part of Pfizer, when the same 

Pfizer official signed the consulting agreement and the material transfer 

agreement? Why did Dr. Sunderland, who has an excellent reputation as 

a researcher and is considered beyond reproach as the Chairman for 10 

years of NIH’s Institutional Review Board put himself in the position of 

being under investigation? 

 In learning more about the circumstances of Dr. Sunderland’s 

conduct, the committee’s investigation uncovered other serious questions 

about the adequacy of NIH policy and oversight regarding human tissue 

samples. For example, Dr. Sunderland transferred the human tissue 

samples taken from subjects for a new research purpose without 

consulting with NIH officials or even the Institutional Review Board in 

charge of protecting these samples. Is that a violation of ethical rules, or 

is that an acceptable practice? 

 From the available evidence, Dr. Sunderland alone, it appears, 

decided to transfer a large number of human tissue samples to Pfizer, a 

company in which he had a financial consulting interest. But would 

Alzheimer’s disease research have been better served if Dr. Sunderland 

had consulted with the other NIH experts and tested the samples, not just 

with the technology involved in the Pfizer projects, but with other 

technologies with other companies as well? 

 We hope to gain more insight to these matters and improve the 

operations of NIH for the benefit of the American people. Already, this 

investigation has led NIH to revise informed consent requirements and 

has helped stimulate discussions within the Institutes to improve policies 

related to human tissue samples. Some of the concerns raised have also 

led to the Institutes making new inquiries about human subject protection 

and assignment of patent rights involved in the Dr. Sunderland matter. 

 Today, we will have one witness, and that is Dr. Susan Molchan, 

who helped raise these concerns over human tissue samples, and then 

tomorrow we will have witnesses from NIH, including the Deputy 

Director of Intramural Research, a former Pfizer scientist who worked 

with Dr. Sunderland, an associate of Dr. Sunderland’s involved in the 

Pfizer activities. 

 I want to thank Chairman Barton for his support of this investigation, 

and Mr. Dingell and Mr. Stupak for their support, and we look forward to 

Dr. Molchan’s testimony. 

 [The prepared statement of Hon. Ed Whitfield follows:] 

THE PREPARED STATEMENT OF THE HON. ED WHITFIELD, CHAIRMAN, SUBCOMMITTEE ON 

OVERSIGHT AND INVESTIGATIONS

 Today and tomorrow, the Subcommittee examines the increasingly important issue 

of human tissue samples. These samples – such as blood, cells, and spinal fluid – are the 
5

raw material of biomedical research that can help improve our healthcare. These samples 

matter because of their growing importance in biomedical research. Detailed genetic and 

other biological marker information can be derived from these samples. With such 

information, we could dramatically improve the way we diagnose and treat disease. 

 The National Institutes of Health (NIH) is at the forefront in collecting these 

samples and using them for unique medical research not conducted in university or 

industry labs. NIH scientists obtain these samples through a great deal of care and work 

with patients and healthy volunteers who participate in biomedical experiments. The 

ability of NIH researchers to get samples from people and the resources and the freedom 

to research relies on trust. These hearings focus on whether that system of trust 

behind the human samples research at NIH is working as well as it could. 

We look at this important question through the prism of a case study – an approach 

this Subcommittee uses often in its oversight hearings. The case study involves Dr. Trey 

Sunderland of the National Institute of Mental Health (NIMH) and the vials of human 

spinal fluid and plasma he shipped to Pfizer from 1998 to 2004. Some members of the 

Subcommittee may recall Dr. Sunderland’s name from the Subcommittee’s June 2004 

hearing where we revealed the discrepancies between information provided by Pfizer 

documenting over $500,000 in outside consulting payments to Dr. Sunderland over a 

five-year period and the information given by NIH to the Committee showing no 

documentation of disclosure and approval of these very same outside consulting activities 

for Dr. Sunderland. 

 NIH has investigated these discrepancies and made its determination of multiple 

violations of legal and ethical requirements. But today’s inquiry is about an investigation 

beyond these compliance issues. We are concerned about the integrity of NIH research. 

The Committee’s concerns in this area were prompted in part by Dr. Susan 

Molchan, Program Director for Alzheimer’s Disease Research at the National Institute of 

Aging (NIA). From 1993 to 1995, she conducted a small clinical trial involving the 

collection of spinal fluid from about 25 people (some patients with Alzheimer’s disease 

and some normal volunteers) and the use of lithium as a probe for potential biomarkers of 

Alzheimer’s disease in spinal fluid and blood. In early 1997, Dr. Molchan left the 

NIMH, but she had not finished this study. She had published two papers and told the 

Committee staff that she had used at the very most 20% of the spinal fluid collected. The 

unused spinal fluid remained stored in freezers at the NIMH Geriatric Psychiatry Branch. 

The Chief of the Geriatric Psychiatry Branch, Dr. Trey Sunderland, assumed control of 

the spinal fluid samples after Dr. Molchan left NIMH. 

In the fall of 2004 Dr. Molchan was at the NIA and was trying to assist an outside 

researcher in getting unused samples from Dr. Molchan’s unfinished study held at NIMH. 

Ultimately by March 2005, Dr. Molchan learned that Dr. Sunderland was only able to 

produce a small percent of unused spinal fluid that remained from the lithium study and 

that the clinical data from that study had been purged. (SLIDE 4) She was concerned 

about what happened to the more than 95% of the unused spinal fluid samples left in the 

freezer and to the data. 

She pursued her concerns for several weeks during March-April 2005 through 

various NIH channels and with the Office of Inspector General (OIG), Department of 

Health and Human Services (HHS). In April 2005 she contacted staff with the 

Committee on Energy and Commerce. After more preliminary work from the Committee 

staff, the bipartisan leadership of the Committee and the Subcommittee started a broad 

investigation on the issue of human tissue samples at NIH and the particular case study 

involving Dr. Sunderland and the spinal fluid samples. 

 The Committee has been investigating this matter for a year. We requested records 

and information. After reviewing the records and interviewing people, the Committee 

staff assembled evidence in its report for the Subcommittee members. The report – 

which will be placed in the hearing record -- raises some troubling questions. 
6

Dr. Sunderland is a leading researcher in the area of Alzheimer’s disease. For years, 

he had been interested in finding a diagnostic test for this disease. Pfizer was also 

interested in this goal. This joint interest was worthy of a scientific collaboration 

between government and the private sector. 

In 1998 Dr. Sunderland had an opportunity to pursue this project legitimately with 

Pfizer and a British biotechnology firm under existing laws and policies that promote 

public-private partnerships. Instead, the evidence shows that Dr. Sunderland used his 

public office to provide spinal fluid and plasma samples to Pfizer. At the same time, Dr. 

Sunderland engaged in personal consulting with Pfizer about these very same samples. 

He did not disclose these consulting arrangements to NIH – this Subcommittee exposed 

them. Ever after he was under investigation, the records show that Dr. Sunderland did 

not accurately describe the nature of his Pfizer consulting activities to NIH. According to 

the records obtained by the Committee, Dr. Sunderland provided over 3,000 spinal fluid 

and plasma samples to Pfizer (SLIDE 5) and received $285,000 from Pfizer for two 

different projects using these samples. (SLIDES 1 and 2) 

The Congress and NIH have provided the proper mechanisms for governmentindustry partnerships. Federal laws and policies do not permit NIH scientists to profit 

personally from their jobs and their patients by providing irreplaceable government 

assets. Unfortunately, the evidence before us shows Dr. Sunderland operated outside that 

system. Why did he choose to enrich himself? There were mechanisms available to get 

resources for his lab as part of this collaboration. But there are no records or information 

showing this was done. Why not? 

There were mechanisms available to him and NIH scientists to get patents and 

royalties. Dr. Sunderland, however, assigned his patent rights to Pfizer under one of the 

two research projects and he was listed as a co-inventor at his home address. Why didn’t 

he tell NIH? Why didn’t he protect the rights of NIH? What about the Alzheimer’s 

disease patients and human volunteers who had their spines punctured and then had to lie 

on their sides for three hours afterward? Did Dr. Sunderland tell them he was going to 

make money from their spinal fluid? Why did Dr. Sunderland make a statement and 

reaffirm to NIH investigators that his outside activities were with one part of Pfizer, and 

that the material transfer agreement, his official activities in providing the samples, were 

with another part of Pfizer when the same Pfizer official signed Dr. Sunderland’s 

consulting agreements and the material transfer agreement? Why did Dr. Sunderland – 

who had an excellent reputation as a researcher and was considered beyond reproach as 

the Chairman for 10 years of NIMH’s Institutional Review Board – put himself in the 

position of being under investigation? 

In learning more about the circumstances of Dr. Sunderland’s conduct, the 

Committee’s investigation uncovered other serious questions about the adequacy of NIH 

policy and oversight regarding human tissue samples. For example, Dr. Sunderland 

transferred the human tissue samples taken from human subjects for a new research 

purpose without any consultation with NIH officials or the Institutional Review Board in 

charge of protecting human subjects. Is that a violation of ethical rules or acceptable 

practice? From the available evidence, Dr. Sunderland alone decided to transfer a large 

number of human tissue samples to Pfizer, a company in which he had a financial 

consulting interest. But would Alzheimer’s disease research have been better served if 

Dr. Sunderland had consulted with other NIH experts and tested the samples not just with 

the technology involved in the Pfizer projects but with other technologies with other 

companies? 

 We aim at these hearings to gain more insight into these matters and improve the 

operations of NIH for the benefit of the American people. Already this investigation has 

led NIH to revise informed consent requirements and has helped stimulate discussions 

within NIH to improve policies related to human tissue samples. Some of the concerns 
7

raised have also led to NIH making new inquiries about human subject protection and 

assignment of patent rights involved in the Dr. Sunderland matter. 

Today we will hear from Dr. Susan Molchan who helped raise the concerns over 

human tissue samples. Tomorrow, we will have witnesses from NIH including the 

Deputy Director for Intramural Research, a former Pfizer scientist who worked with Dr. 

Sunderland, an associate of Dr. Sunderland involved in the Pfizer activities, and Dr. 

Sunderland himself. 

 I want to thank Chairman Barton for his support of this investigation. I also want to 

thank Mr. Dingell and Mr. Stupak for their support of this investigation. I also want to 

note that Pfizer was cooperative with the Committee’s investigation and we appreciate 

that. 

I look forward to hearing from the witnesses. 

 MR. WHITFIELD. At this time, I recognize Mr. Stupak. 

 MR. STUPAK. Thank you, Mr. Chairman, and thanks for holding this 

hearing today. We are going to have another one tomorrow. 

 This inquiry has been a bipartisan effort for the past year. The staff 

report released today provides the committee with a sound basis to do 

our work. I compliment the bipartisan committee staff work and their 

report. Through no fault of our staff, I do note that this investigation 

took much longer than should have been necessary. The National 

Institutes of Health and/or its overseers at the Department of Health and 

Human Services apparently had a hard time understanding our bipartisan 

request letter. Like other initial inquiries from the committee, they 

originally treated our request like a nuisance, something to respond to in 

a perfunctory way. 

 For instance, instead of supplying the committee with documents 

showing the disposition of the specific spinal fluid samples as requested, 

NIH gave us unsatisfactory excuses, such as possible freezer failure. We 

subsequently learned that NIH had records of the samples we requested, 

which were among 3,300 tubes of fluid samples shipped to Pfizer. 

 In the 2004 conflicts of interest investigation, the subcommittee 

discovered that about 100 NIH scientists failed to report income from the 

20 drug companies that the committee had surveyed. Pfizer and other 

drug companies had the records; of course, NIH did not. Fortunately for 

this investigation, when we could not get the records of samples shipped 

out of the National Institute of Mental Health lab, Pfizer again had the 

records. I find it very disturbing that Pfizer has kept better records than 

NIH. 

 Interestingly, both of these investigations touched on a specific 

National Institute of Mental Health lab chief, Dr. Trey Sunderland. Only 

after this subcommittee provided this information to NIH 2 years ago did 

NIH become aware of Dr. Sunderland’s receiving over $500,000 from 

Pfizer without reporting it. Yet, when we requested an accounting of the 

human tissue samples in Dr. Sunderland’s control, NIH officials 

apparently accepted his explanation that such records did not exist. This 
8

represents a complete lack of due diligence and negligence on the part of 

NIH. Unfortunately, the performance of the Department of Health and 

Human Services Inspector General, was similarly lacking. Because there 

is an ongoing inquiry, we will delay the examination of the performance 

of those investigators, but our preliminary information is that this IG 

continues to ignore its first responsibility, which is to keep the 

Department clean. 

 Mr. Chairman, the NIH has much to account for today. Priceless 

human tissues samples, samples from a unique collection that is not 

likely to be replicated, even at NIH, were shipped without any authority, 

any oversight, any accountability for a private research effort that was 

evaluated by a single government employee. That employee was Dr. 

Sunderland, a lab chief who, in the end, would pocket $285,000 from his 

decisions. We estimate that those samples cost NIH over $6 million, and 

took 15 years to collect. 

 As you noted, Mr. Chairman, spinal fluid is not easy to obtain. It 

involves three or more hours of inconvenience and often considerable 

pain for each volunteer on each occasion. People volunteered those 

samples to advance Alzheimer’s research, most often because they or 

their loved ones suffered from this disease. The volunteers trusted the 

judgment that NIH would put their samples to best use. Unfortunately, 

NIH’s failure to supervise its employees permitted a single scientist to 

make the judgment to give away irreplaceable samples. The lack of 

oversight also allowed Dr. Sunderland to take some 140 days of travel to 

perform his Pfizer consults. The failure to demand accountability 

allowed one of the two corroborative research projects to proceed 

without any protection of NIH’s right to the resulting data or right to 

intellectual property resulting from the research. As a result, Pfizer owns 

all research products. 

 Of course, NIH didn’t know any of this until we asked, because they 

have no uniform audit policy for acquisition, use, and/or storage of 

human tissue samples; storage and protection of data generated by their 

research; determination of whether human subject protection and 

informed consent are assured after any specific protocol is ended; 

accounting for leave of senior employees; assuring that the appropriate 

legal instruments are used when human tissues are transferred; or 

accounting for the fruits of corroborative research data and patents. 

 Mr. Chairman, it is time to rectify the inadequate oversight that has 

enabled these reckless activities to occur. Congress entrusts NIH with 

billions of dollars each year. Biomedical research needs to be guided by 

an unbiased assessment of producing strategies for diagnosis or 

treatment, not whether an NIH researcher maximizes his or her personal 

gain. Furthermore, thousands of Americans entrust NIH with their 
9

personal medical histories, tissue samples, and other information each 

year to help find cures for diseases. We need to honor their commitment 

by ensuring that the highest scientific standards are upheld. 

 Mr. Chairman, I yield back the balance of my time. 

 MR. WHITFIELD. Thank you, Mr. Stupak. 

 At this time, I will recognize the gentleman from Texas, Dr. Burgess. 

 MR. STUPAK. Mr. Chairman, if I may, before Dr. Burgess, I ask 

unanimous consent to enter into the record the statement of Mr. Dingell, 

the Ranking Member of this committee. Thank you. 

 [The prepared statement of Hon. John D. Dingell follows:] 

THE PREPARED STATEMENT OF THE HON. JOHN D. DINGELL, A REPRESENTATIVE IN 

CONGRESS FROM THE STATE OF MICHIGAN

Mr. Chairman, thank you for holding this hearing and initiating this bipartisan 

investigation. This inquiry is an example of how productive oversight can be when it is 

truly bipartisan. And it has been bipartisan from the first Chairman’s letter to the staff 

report we have before us today. You and Representative Stupak have worked together 

and our staffs have worked together each step of the way. 

What have we uncovered? For one thing a number of serious deficiencies in 

individual National Institutes of Health (NIH) processes that are enumerated in the staff 

report. No one looks to see if priceless human tissue samples are being put to their best 

use. No one is looking to see if human subject protection rules are followed. No one has 

to account for his or her time or budget. 

Trusting scientific decisions to the scientists is one thing. Giving carte blanche to 

individual researchers to spend funds and divert precious human tissue resources derived 

from patients under their care is quite another. 

Congress has taken the approach that biomedical research decisions are best left to 

the scientists. This is as it should be. We owe it to the taxpayers, however, to ensure that 

the scientists who make decisions regarding very expensive life and death research 

options do so in a rational manner with accountability at least within the scientific 

community. 

These investigations and the conflict of interest hearings held in 2004 have exposed 

a severe structural weakness in the oversight functions within NIH. First it was ethics, 

now it is something even broader. Dr. Zerhouni did a good job tightening up the ethical 

environment after our last set of hearings. I hope Dr. Gottesman will undertake a similar 

clean-up campaign designed to return accountability to this great institution. 

 MR. BURGESS. Thank you, Mr. Chairman, and thank you for your 

continued leadership in the investigation that has become another very 

important public health issue. 

 During my tenure in Congress, I have had the privilege of visiting 

the National Institutes of Health several times. After each visit, I come 

away encouraged; encouraged by the research and the studies that the 

scientists perform on a daily basis. After each visit, my hope that a cure 

for cancer, a cure for Alzheimer’s will be found, if not during my 

lifetime, then perhaps during the lifetime of my children. 
10

 I would like to take this opportunity to sincerely thank the doctors, 

researchers, and scientists at the National Institutes of Health for their 

dedication to such a noble profession. It is my opinion that outside 

consulting by scientists is not within itself an unethical practice. While 

outside consulting is currently prohibited by NIH employees, I believe 

that these types of arrangements can be beneficial to society as a whole if 

constructed in an ethical and transparent manner. 

 The situation before us involving Dr. Sunderland is an egregious 

example of how the system can fail if there is lack of transparency and a 

lack of ethical behavior. Dr. Molchan, thank you for bringing this 

situation to our attention. 

 In preparation for today’s hearing, the committee released a 

bipartisan staff report to the members of this subcommittee. I think it is 

important to note that the bipartisan staff report came to a concluding 

paragraph, and I am quoting here, “It should be noted that the committee 

staff found no evidence that Pfizer had any knowledge relating to the 

questionable conduct of Dr. Sunderland in connection with the April, 

1998, material transfer agreement and subsequent shipments of samples.” 

The unethical practice lies clearly and solely with Dr. Sunderland. 

 Congress continues our work on reauthorization of the National 

Institutes of Health, a program that spends almost $30 billion a year, and 

it is money well spent. I feel certain that we can use the lessons learned 

today and tomorrow throughout the reauthorization process. It is our role 

to provide adequate oversight over the National Institutes of Health and 

ensure that taxpayer dollars and other resources, including tissue 

samples, are used in a worthwhile and ethical manner. We must not 

abrogate our responsibility to the American public regarding this 

important task. 

 Mr. Chairman, again I thank you for holding this hearing, and look 

forward to a lively discussion on the procedures concerning human tissue 

samples. I will yield back the balance of my time. 

 MR. WHITFIELD. Thank you, Dr. Burgess, and I would, without 

objection, want to enter into the record the staff report on this entire 

issue, as well as those slides and the exhibits. Without objection, so 

ordered. 

 [The information follows:] 
11

A STAFF REPORT 

For the Use of the Subcommittee on Oversight and Investigations 

In Preparation for Its Hearing, 

“Human Tissue Samples: NIH Research Policies and Practices,” June 13-14, 2006 

This staff report was written by the Majority and Minority Committee staff of the 

House Committee on Energy and Commerce. 

Background 

 Human tissues are biological materials defined as “including everything from 

subcellular structures like DNA, to cells, tissue (bone, muscle, connective tissue, and 

skin), organs (e.g., liver, bladder, heart, kidney), blood, gametes (sperm and ova), 

embryos, fetal tissue, and waste (urine, feces, sweat, hair and nail clippings, shed 

epithelial cells, placenta).”1

 For purposes of the Subcommittee’s inquiry, this report 

focuses on biological materials most frequently used in biomedical research such as 

tissues and cells. These are raw biological materials extracted from human beings that 

are to be distinguished from the biological inventions derived from such samples. These 

extracted tissues are stored and generate portions of tissues called samples. 

 Ever since 1858 when Rudolf Virchow wrote his famous book that detailed how 

changes in cells accounted for diseases in organs, human tissue samples have been the 

foundation of biomedical research.2

 In its 1999 report, the RAND Corporation published 

a “conservative estimate” that more than 307 million tissue samples from more than 178 

million people were stored in the United States.3 This number was reportedly increasing 

by more than 20 million samples a year. 4

 Tissue samples have played a central role in 

major studies such as the Framingham studies on heart disease and the Women’s Health 

Initiative (WHI), one of the largest women’s health studies in which over a 15-year 

period, 161,000 women gave blood, urine, and other samples to investigators.5

 Human 

tissue samples also have significant value to biotechnology and pharmaceutical 

companies because these materials “can help them: reduce drug development times; 

develop new therapies and drugs; react quickly to unexpected adverse reactions; and 

identify new assay techniques or biomarkers.”6 

 The issue of human tissue samples has assumed greater importance at the National 

Institutes of Health (NIH) and strengthened the need for more guidance to NIH-funded 

institutions (NIH’s extramural research program that are more than 80 percent of the 

NIH’s budget) as well as for the Institutes and Centers at the NIH that conduct their own 

research (NIH’s intramural research program). As noted by the NIH’s Director of the 

Office of Science Policy to NIH staff: “[H]uman specimen repositories and the use of 

human specimens and data are becoming an increasingly important part of our efforts to 

 

1

 Eiseman, E. and Castillo, J., Handbook of Human Tissue Sources, RAND Monograph Report, 7 

(1999). See also U.S. Congress, Office of Technology Assessment, New Developments in 

Biotechnology: Ownership of Human Tissues and Cells – Special Report, OTA-BA-337 (March 

1987) at 3. 

2

 Hakimian, R. and Korn, D., “Ownership and Use of Tissue Specimens for Research,” Journal of 

the American Medical Association, November 24, 2004, at 2500. 

3

 Eiseman, E. and Castillo, J., Handbook of Human Tissue Sources, RAND Monograph Report,xvii 

(1999). 

4

 Id. The National Bioethics Advisory Commission (NBAC) estimated that as of 1998, more than 

282 million specimens of human biological materials were stored in the United States, accumulating 

at a rate of more than 20 million cases per year. 

5

 Hindin, T., “Technology and Clinical Trials,” Applied Clinical Trials, April 2006 at 12. 6

 Mills, J.F., “Precedents for Good Storage Practice,” Applied Clinical Trials, April 2006 at 58. 
12

advance basic science research and translate discoveries into improved medical care. 

However, the lack of consistency in the regulations, policies and procedures governing 

this type of research is creating confusion and barriers for researchers, repository 

managers, IRB [Institutional Review Board] staff, and their institutions. The magnitude 

of these challenges will likely grow as advances in informatics make it possible to make 

human datasets of unprecedented size and scope widely available to the research 

community.”7 In response to these perceived challenges and as part of the NIH 

Roadmap, the NIH is coordinating “a high priority effort to develop trans-NIH policies to 

govern NIH funded research with human specimens and data and to work across 

government to promote more consistent policies in this area.”8

 The focus of the inquiry for this hearing is the collection, storage, tracking, and use 

of human tissue samples in the NIH intramural research program. 

The Committee’s investigation in this area was prompted in part by concerns raised 

by Susan Molchan, M.D., Program Director for Alzheimer’s Disease Research at the 

National Institute of Aging (NIA), to Committee staff in April 2005. Dr. Molchan had 

been a clinical researcher interested in Alzheimer’s disease research at the National 

Institute of Mental Health (NIMH). From 1993 to 1995, she conducted a small clinical 

trial involving the collection of spinal fluid from about 25 people (some patients with 

Alzheimer’s disease and some normal volunteers) and the use of lithium as a probe for 

potential biomarkers of Alzheimer’s disease in spinal fluid and blood. In early 1997, Dr. 

Molchan left the NIMH, but she had not finished this study. She had published two 

papers and used at the very most 20 percent of the spinal fluid collected. The unused 

spinal fluid remained stored in freezers at the NIMH Geriatric Psychiatry Branch. The 

Chief of the Geriatric Psychiatry Branch was Trey Sunderland, M.D., who assumed 

control of the spinal fluid samples after Dr. Molchan left NIMH. 

At a hearing on June 22, 2004, the Subcommittee on Oversight and Investigations 

revealed that Dr. Sunderland had received over $500,000 in payments from Pfizer during 

1999-2004 for outside consulting and speaking without any record of prior approval for 

these activities or disclosure in his government financial-report filings. 

 By the fall of 2004, Dr. Molchan had been back at the NIH for three years, this time 

at the National Institute of Aging. At a meeting of top scientists and researchers, she 

learned that an outside researcher was pursuing funding for a lithium study similar to the 

one that Dr. Molchan had been unable to complete at NIMH. Spinal fluid samples are 

extremely valuable and very difficult to obtain. The outside researcher was very 

interested in getting Dr. Molchan’s assistance in obtaining the spinal fluid samples and 

the linked clinical data from her study. Dr. Molchan agreed to assist. In the fall of 

2004, Dr. Molchan asked Dr. Sunderland about the samples. After two months of 

inquiries, Dr. Sunderland sent two 0.5 cc samples from 10 subjects (about 2-3 percent of 

the unused amount of spinal fluid) to the outside researcher. In March 2005, Dr. 

Molchan asked Dr. Sunderland about the linked clinical data. Dr. Sunderland told her 

that that the data had been purged because it was over 5-7 years old and subject to 

purging. 

 Dr. Molchan was concerned about what happened to the more than 95 percent of the 

unused spinal fluid samples left in the freezer and to the data. In particular, after the 

public reports about Dr. Sunderland’s undisclosed activities with Pfizer, she was 

concerned that Dr. Sunderland might have inappropriately or improperly diverted spinal 

fluid samples from her lithium study to Pfizer as part of his financial relationship. She 

pursued her concerns for several weeks during March-April 2005 through various NIH 

channels and with the Office of Inspector General (OIG), Department of Health and 

 

7

 Email on “Harmonization and Repositories,” from Lana R. Skirboll, Ph.D., Director, Office of 

Science Policy, NIH, October 27, 2005 to various NIH staff. 

8

 Id. 
13

Human Services (HHS). In April 2005 she contacted staff with the Committee on Energy 

and Commerce. 

 In investigating her concerns and in general about the relevant NIH policies, the 

Committee staff learned from NIH officials that NIH had no uniform, centralized, and 

mandatory authority regulating the handling of human tissue samples. Some NIH 

laboratories kept a written record on the maintenance of these samples, but other NIH 

laboratories did not. Although there were explicit regulations defined in 42 C.F.R. 72.6 

detailing the handling for hazardous biological materials and select agents, there was no 

explicit policy for the handling and accounting of human tissue samples. In addition, 

there was no formal inventory control or tracking system at NIH. If a freezer or other 

storage facility malfunctions and the human tissue samples become unusable, NIH 

laboratories were not required to account for the disposition of these samples. There was 

reason to believe that there were cases where NIH lost human tissue samples but had no 

record of what had been lost. Moreover, the lack of accountability left NIH wholly 

vulnerable to theft and diversion of valuable human tissue samples. These preliminary 

inquiries raised serious concerns over what was described to Committee staff by NIH 

officials as a fairly loose, ad-hoc approach to controlling human tissue samples. 

On June 20, 2005, the bipartisan leadership of the full Committee and the 

Subcommittee sent a letter to the Director of the NIH requesting records and information 

on how human tissue samples are obtained, stored, tracked, and used in intramural 

programs throughout the institutes and centers of the NIH.9 In the context of this 

investigation, the Committee focused primarily on spinal fluid samples and blood 

samples obtained from patients and other people participating in NIH intramural clinical 

trials. 

One subject area of the Committee’s June 20, 2005, request concerned the 

disposition of spinal fluid samples from patients with Alzheimer’s disease and control 

subjects collected by scientists at the National Institute of Mental Health (NIMH) to be 

used in studies involving lithium. After the NIH’s August 15, 2005, production, the 

Committee staff alerted the NIH that it appeared that not all responsive documents 

concerning these samples and Dr. Molchan’s lithium study had been provided to the 

Committee. After the Committee staff raised these concerns with NIH about the 

production, the Committee did receive additional responsive records: three sets of records 

over the last few months from the NIH related to the spinal fluid samples and the lithium 

study, with the last set received on January 4, 2006. The Committee was troubled that the 

NIH did not produce all the responsive records in the first production, and produced these 

records only after Committee staff pressed several times for these additional responsive 

records. Most importantly, an NIH document received by the Committee in early 2006 

 

9

 The current total number of tissue samples at the NIH is unknown. As the NIH wrote to the 

Committee in a letter dated August 15, 2005: 

 “NIH does not maintain a central listing of all tissue samples in its possession. Each laboratory 

is responsible for storing and tracking all samples within its possession. NIH requires that each 

investigator obtaining such samples complete a Human Pathogen Registration Document, [ ], which 

requires information on the principal investigator, the location of the work, the agent or human 

blood, body fluid or tissue being worked with, and the names of all individuals working with the 

particular material being registered. The document does not require the investigator to supply the 

number of samples that he/she plans to work with or obtain. NIH currently has 390 Human 

Pathogen Registration Documents on file for human blood, body fluids, and/or tissues. Currently, 

663 laboratories maintain human blood, body fluids, and/or tissue samples. [footnote omitted]. A 

total of 2340 employees are registered for work involving human blood, body fluids, and/or tissues. 

It is important to note that these numbers apply only to active research protocols. 

 In addition, NIH maintains biorepositories to provide investigators with pathological samples 

for research uses. Two are maintained by the National Cancer Institute, . . . ” 
14

documented that the Geriatric Psychiatry Branch (GPB) had sent spinal fluid samples to 

Pfizer from 538 subjects, who had participated in 14 different studies at NIMH. (See 

Exhibit 26) The protocol numbers listed on the documents showed that spinal fluid had 

been sent to Pfizer from subjects who had participated in Dr. Molchan’s lithium study. 

That fact had not been previously disclosed to either Dr. Molchan or to the Committee. 

On January 24, 2006, the bipartisan leadership of the Committee and the 

Subcommittee sent a letter to NIH requesting additional records about the disposition of 

the spinal fluid samples, the nature of NIMH oversight over human samples, and the way 

NIH/NIMH handled the Committee’s request for records relating to the lithium study. In 

addition, on January 24, 2006, the bipartisan leadership of the Committee and the 

Subcommittee sent a letter to Pfizer, requesting records that could help determine the 

relationship, if any, between the disposition of the spinal fluid samples in question and 

Dr. Sunderland’s official and/or private consulting activities with Pfizer. 

Methodology

To review these issues related to human tissue samples, the Committee staff 

conducted extensive interviews with officials from NIH, former officials with NIH, 

officials with Pfizer, former officials with Pfizer, and other individuals.10 Staff reviewed 

documents obtained by the Committee from NIH and Pfizer. Staff also reviewed public 

information and records. 

NIH’s Internal Investigation

The NIH’s Office of Management Assessment (OMA) conducted an internal 

investigation of Dr. Sunderland’s outside activity discrepancies first revealed in 

substantial part at the Subcommittee’s June 22, 2004, hearing. The OMA found that Dr. 

Sunderland engaged in serious misconduct, in violation of HHS ethics rules and Federal 

law and regulation. The OMA confirmed that there was no documentation for Dr. 

Sunderland seeking prior approval or reporting the Pfizer activities. After the revelations 

of the Pfizer activities, Dr. Sunderland self-reported additional activities with other drug 

or biotech companies that lacked required documentation in which his payments almost 

totaled $200,000. Dr. Sunderland claimed that these were paperwork violations and that 

his outside activities did not constitute conflicts of interest with his official duties. In 

particular, Dr. Sunderland contended that his outside consulting did not relate to his 

official duty collaboration with Pfizer, which involved the sharing of spinal fluid samples 

under an April 1998 Material Transfer Agreement (MTA). However, the Ethics Review 

Panel convened by NIH in April 2005 found a direct overlap between the subject matter 

of Dr. Sunderland’s official area of research and the scientific subject matter of his Pfizer 

consultancies. In addition, the Panel expressed concern over the 1998 MTA that Dr. 

Sunderland entered into with Pfizer while he maintained an ongoing consulting 

relationship with the company in the same area. In addition, in a memorandum dated 

October 12, 2005, the NIH Ethics Panel found that Dr. Sunderland’s official duties 

constituted an overlap with some of unapproved outside activities with other drug 

companies he self-reported. (Exhibit 35) 

On September 24, 2004, NIH referred an allegation to the Office of Inspector 

General - HHS (OIG) that Dr. Sunderland may have conducted outside activities during 

Government work hours without charging leave. Other records in connection with Dr. 

Sunderland beyond the issue in the referral have also been forwarded by NIH to the OIG. 

 

10 Committee staff requested numerous times to interview Dr. Sunderland, but through his attorneys 

he declined to be interviewed. 
15

Committee’s Investigation

 It should be noted that the NIH investigated Dr. Sunderland’s failure to obtain prior 

approval and disclose outside activities. NIH did not investigate the details of the 

underlying outside activities at issue. The concerns raised about human tissue samples 

led the Committee to investigate issues that arose from Dr. Sunderland’s transfers of 

human tissue samples to Pfizer and examined the details of Dr. Sunderland’s two 

principal consulting arrangements with Pfizer. This staff report is a preliminary report to 

assist the Members of the Subcommittee on Oversight and Investigations in preparing for 

the hearings to be held on June 13 and 14, 2006. 

Question One: Did Dr. Sunderland obtain personal financial benefits from outside 

activities (with no record of disclosure to NIH or approval by NIH) with Pfizer, Inc., 

in any way because of actions he took in his official capacity in facilitating the 

transfer to Pfizer of human spinal-fluid samples and plasma samples, which were 

the assets and property of NIH? 

Finding/Supporting Evidence: Yes. Records and interviews provide reasonable grounds 

to believe that Dr. Sunderland personally received $285,000 in compensation from Pfizer 

for activities that were derived directly from his official acts in providing Pfizer access to 

spinal fluid samples and plasma samples (over 3000 tubes of NIH property and linked 

clinical data) and that Dr. Sunderland used NIH employees and resources to provide such 

access. 

Discussion: 

The Committee’s inquiry focused on the consulting agreements involving Dr. 

Sunderland’s collaborations with Pfizer using human tissue samples procured from his 

Geriatric Psychiatry Branch in the National Institute of Mental Health (NIMH). Records 

from Pfizer show that the transfer of spinal fluid samples from Dr. Sunderland’s branch 

at NIMH to Pfizer under an April 1998 Material Transfer Agreement coincided with the 

initiation of a two-year consulting agreement related to Dr. Sunderland’s advice on 

information generated from those samples. The MTA and the consulting agreement were 

part of the same scientific collaboration. This consulting agreement and a spin-off 

consulting agreement from the collaboration netted Dr. Sunderland a minimum of 

$25,000 per year plus $2,500 per day for each one-day meeting (1998-2003). According 

to Pfizer, payments under these two contracts totaled $285,000, exclusive of 

reimbursement of travel expenses.11 

Dr. Sunderland had been collecting human tissue samples and the related clinical 

information from NIH Alzheimer’s disease patients and their families and controls since 

the early 1980s. This longitudinal collection of spinal fluid and blood samples was 

unique. While it was possible to purchase spinal fluid samples from Alzheimer’s disease 

patients, individuals interviewed by Committee confirmed it was unlikely that anywhere 

but at the clinics of NIH could this unique historical collection of human tissue samples 

be assembled. Dr. Sunderland collected not only human tissue samples from Alzheimer’s 

 

11 The consulting payments were in addition to sums Pfizer paid Sunderland for speeches or 

discussions with potential prescribers of Aricept and the occasional advisory board participation. 

Those payments added an additional $311,000 over roughly the same period of time as the 

consulting agreements. While such payments are now not permitted under the ethics rules, a special 

NIH ethics panel concluded that had Dr. Sunderland requested approval for these speeches, they 

would have been approved under the standards that predated the Committee’s investigation and 

resulting reforms. 
16

disease patients but also samples from their blood relatives as well as samples from 

controls. 

The longitudinal aspect included in this collection gave the samples their unique 

character. At least some of the subjects had samples drawn both before and after the 

onset of Alzheimer’s disease. Interviews and records obtained from Pfizer provide 

reasonable grounds to believe that obtaining these spinal fluid samples together with their 

clinical histories was a primary reason for Pfizer’s interest in collaborating with Dr. 

Sunderland. 

The samples themselves and the linked clinical data associated with these samples 

are generally considered to be valuable assets because such samples can be used for 

diagnostic, therapeutic, research, and commercial purposes. NIH has told the Committee 

that it takes the position that tissue samples are the property of the U.S. Government to 

the extent that NIH asserts an exclusive right to control the disposition and distribution of 

that material.12 That would seem to be the case where the NIH has exclusive possession 

and control of the samples through its storage of these materials in its freezers in its own 

buildings, all funded by U.S. taxpayers. NIH continually asserts its ownership interests 

in such samples through its technology transfer policies and legal contracts such as 

Material Transfer Agreements (MTAs) and Cooperative Research and Development 

Agreements (CRADAs). In addition, the NIH-1884 form “Request for shipment” used to 

ship tissue samples to Pfizer noted that they were shipments of government-owned 

property. (See Exhibit 22) 

Three legal documents were involved in the transfer of invaluable human tissue 

samples and the collaborative research that resulted: a material transfer agreement (MTA) 

between NIH and Pfizer signed by Dr. Trey Sunderland and two consulting contracts 

between Pfizer and Dr. Sunderland. 

A material transfer agreement is to be distinguished from a collaborative research 

and development agreement (CRADA) and a consulting agreement involving the scientist 

and a company independent of the NIH. In a scientific endeavor such as the 

Pfizer/Sunderland collaboration, according to some NIH officials interviewed by 

Committee staff, a CRADA would have been the appropriate legal umbrella for this kind 

of research. (This is discussed in more detail later in this report.) Not only would that 

arrangement spell out the contributions and obligations of both parties, but it also would 

spell out the distribution of data and intellectual property rights between the government 

and the private sector firm, in this case Pfizer. Had a CRADA been negotiated, Dr. 

Sunderland would not have been able to receive any outside income for his efforts in the 

collaboration as it would have been part of his official duties. 

Although NIH policies on technology transfer mechanisms were evolving and 

unclear in 1998, according to an NIH official interviewed by Committee staff, because 

the transfer involved a commercial entity, it is unlikely Pfizer could have taken 

possession of the samples of this value without a document authorizing the transfer. 

Absent a CRADA, an MTA was the instrument that specified the terms under which the 

NIH would release human tissue samples for a specific research purpose. The MTA did 

not obligate Pfizer to share the resulting data with NIH nor did it specify that the 

government retained any intellectual property right to the fruits of the proposed research. 

Based on its past investigations of NIH scientists’ outside consulting agreements, 

Committee staff believes that Pfizer would not have entered into a scientific collaboration 

 

12 In an attached response to an e-mail dated May 12, 2006, from NIH staff to Committee staff, NIH 

stated: 

“Where have tissue samples sitting in a freezer that have been collected from patients in an 

intramural trial, whom do these samples belong to? Still belong to the donor? NIH? Lab scientist? 

Government? If it does not belong to the government, want explanation of why not. 

Tissue samples collected within the intramural program belong to the Federal Government.” 
17

with Dr. Sunderland or any other scientist without a private contract that contained two 

critical clauses: confidentiality and the right of Pfizer to all intellectual property created 

as a result of the collaboration. 

In a CRADA, Pfizer would not have retained exclusive rights to the data or any 

patents. Dr. Sunderland would have been precluded from any outside income from the 

collaboration, if there had been a CRADA such as the one he had executed with Abbott 

Labs in 1989 in transferring 115 spinal fluid samples. (Exhibit 28) 

In this regard it is important to note that Dr. Sunderland is listed as a co-inventor 

with Pfizer researchers on patents filed in Europe and here in the US relating to the April 

1998 MTA.13 (Exhibit 29) Dr. Sunderland executed at least one assignment of his patent 

rights to Pfizer as did his co-inventors as was required by his contract of June 10, 1998, 

and as is typical of discoveries made while on a private payroll. (Exhibit 30) The United 

States is not an assignee. 

In 1997 Pfizer entered into a collaboration with a British firm, Oxford 

Glycosciences (OGS), to identify unknown biomarkers that would signal the onset of 

Alzheimer’s disease using a proprietary OGS proteomics technology. Dr. David 

Friedman, the lead Pfizer researcher on the project, began courting Dr. Trey Sunderland 

in an attempt to obtain access to the NIH human tissue samples in the fall of 1997. 

In his interview with Committee staff, Dr. Friedman said he came to understand the 

significance of the depth of Dr. Sunderland’s expertise in his early discussions. On 

February 20, 1998, Dr. Friedman, and three other Pfizer scientists visited Sunderland’s 

lab at NIMH. A Pfizer e-mail documenting the visit stated: “In discussions regarding 

Pfizer’s needs and Sunderland’s needs, Trey indicated that he was very happy with an 

MTA arrangement plus consulting that Kathy [Smith] has been discussing. Trey was also 

very interested in publication in a reasonable time frame and that he wanted to make sure 

that authorship would be based on scientific and intellectual contributions. We indicated 

agreement on both matters.” 

A month later, at the suggestion of Dr. Sunderland, Kathryn Monaghan (now 

Smith), a Pfizer manager, called Kathy Conn, the tech transfer official at NIMH, about 

using an MTA to transfer spinal fluid samples. Ms. Monaghan believed that this phone 

call reflected NIH’s agreement to proceed with the material transfer agreement and that 

they can “work out the CRADA vs. Consult part in due course.” (Exhibit 31) 

On April 6, 1998 Kathy Monaghan faxed the final version of the MTA to Dr. 

Sunderland and informed him that the deal with OGS had been finalized. (Exhibit 2) 

However, Ms. Conn informed the Committee staff that she was unaware that the final 

MTA had been executed.14 Records and Committee staff interviews of the individuals 

involved revealed that neither the Director of NIMH nor the NIMH Scientific Director, 

the two supervisors of Dr. Sunderland, had knowledge of the transfer of the uniquely 

valuable samples or were informed of the MTA negotiations. On April 8, 1998, Dr. 

Sunderland signed the MTA to transfer coded clinical samples of spinal fluid and the 

accompanying data from over 250 subjects to Pfizer. Six days later, Dr. Barrie Hesp 

signed the MTA for Pfizer. 

In a letter dated April 20, 1998, Pfizer sent Dr. Sunderland at NIH the signed copy 

of the MTA with a note that indicated that they expected the samples to be shipped midMay (Exhibit 1) Dr. Sunderland was then sent a “draft consulting agreement” to his 

home in a letter dated on the same day. (Exhibit 5) A two-year consulting agreement that 

Pfizer labeled the “OGS” agreement was signed by Dr. Hesp (dated June 10, 1998) and 

Dr. Sunderland (dated June 18, 1998) effective May 1, 1998. (Exhibit 7) It provided for a 

 

13 Committee understands from NIH that the NIH has recently made a referral to the OIG-HHS on 

this issue of undisclosed patent applications. 

14 As discussed later, Ms. Conn believed that the next step in the process was Pfizer sending her a 

copy of the MTA to review. This matter is discussed in more detail later in the report. 
18

consulting payment to Dr. Trey Sunderland of $25,000 per year and $2,500 per day for 

each meeting plus expenses. This agreement was renewable for two-year periods, and 

was renewed two more times. 

It should be noted that this consulting agreement required that Dr. Sunderland 

transfer any interest he may have in the research arising from the agreement with Pfizer 

as he subsequently did with the patent assignment. (Exhibit 7) Dr. Sunderland also 

agreed not to “disclose confidential information for so long as it remains unpublished...” 

Only after the consulting agreement was signed were the samples finally shipped 

from NIH. According to Dr. Friedman in his interview with Committee staff, on or 

around June 24, 1998, Drs. Friedman and Sunderland accompanied 621 tubes to OGS in 

Britain. But Dr. Sunderland did not deliver the clinical data associated with the samples 

until August 1998. Emails indicate Pfizer officials were quite upset about the delay 

because the associated clinical information made these samples useful for the intended 

research and this delay would affect the pace of the research. (Exhibit ). Pfizer calls this 

research project involving NIMH and OGS the “unknown biomarkers” project. 

By the end of July 1998, Pfizer and Sunderland decided to pursue a second 

collaboration regarding the validity of already “known biomarkers,” a beta and tau. 

(Exhibit 8) The NIH spinal fluid samples were to be used for this project as well. This 

second project resulted in a second separate consulting agreement for Dr. Sunderland but 

not a new MTA for the transfer of NIH samples for this separate and new Pfizer research 

project. The second consulting agreement was signed by Dr. Hesp for Pfizer with an 

October 6, 1998, date and by Dr. Sunderland with an October 12, 1998, date. On 

February 9, 1999, the shipment of spinal fluid samples from NIH to Pfizer for the 

“known biomarkers” project began. 

According to records and information, approximately 3,200 tubes of spinal fluid and 

388 tubes of plasma were shipped to Pfizer in connection with both biomarker projects.15

(See Slide 5) Of these, 2,200 or so were for the “known biomarkers” project and the 

remaining 1,100 were for the “unknown biomarkers” research. The spinal fluid samples 

linked with the well-characterized clinical data are invaluable tools for scientific research. 

Based on available records, the NIH only had data on the 2,132 tubes shipped in 

connection with the “known biomarkers” project. The Committee staff has reasonable 

grounds to conclude that NIH did not have knowledge of the more than 1,000 tubes of 

spinal fluid shipped pursuant to the “unknown biomarkers” agreement. 

Question Two: Does the available evidence provide reasonable grounds to believe 

that Dr. Sunderland and others omitted important information, or provided 

inaccurate information, about the circumstances surrounding Dr. Sunderland’s 

collaborations with Pfizer, Inc. that involved the human samples provided by Dr. 

Sunderland? 

Finding/Supporting Evidence: Yes. While Dr. Sunderland refused invitations to be 

interviewed by the Committee, records and interviews provide reasonable grounds to 

believe that some of Dr. Sunderland’s statements to the investigators from the Office of 

Management Assessment and communications from Dr. Sunderland’s attorney to NIH 

were factually inaccurate or incomplete, especially statements relating to the nature of the 

Pfizer collaborations involving human tissue samples. 

 

15 According to Pfizer records, what remains of the samples represents about half of what was 

shipped by Dr. Sunderland. Pfizer is “happy to work with NIH to arrange the return of the samples.” 

June 6, 2006 e-mail from Daniel Kracov, Esq. (outside counsel to Pfizer) to Committee staff. 
19

Discussion: 

The Office of Management Assessment (OMA) of the NIH interviewed Dr. 

Sunderland regarding these matters on August 19, 2004. Dr. Sunderland signed the 

interview notes on August 31, 2004, confirming with an “X” that “[t]hese notes, with 

indicated changes, accurately summarize the interview.” (Exhibit 14) Dr. Sunderland 

informed OMA that while he had taken the required ethics courses and understood there 

were rules governing disclosure of financial interests and approval of outside activities 

“he may not have paid proper attention” to such matters in the past. He maintained that 

he did provide the documents from which to complete the 520s (outside activity request 

forms) but that somehow the clerical staff did not make the necessary submissions nor 

did they inform him that such submissions were not made. 

 With regard to his financial disclosure forms, Dr. Sunderland placed blame for at 

least part of their inaccuracy on his support staff. The OMA dismissed this argument: 

“Dr. Sunderland violated NIH and Commissioned Corps procedures and policies on 

multiple occasions (Pfizer reported 140 activities for which there were no approvals) all 

of which cannot be dismissed as administrative oversights or anomalies. Given that he 

acknowledges that he had concerns about administrative support, he should have ensured 

that forms were submitted to the NIMH ethics office and that approvals were given. Dr. 

Sunderland was aware of the NIH ethics process through ethics training and was 

ultimately responsible for ensuring that all activities were approved and all financial 

disclosures were made.” (See Exhibit 32) Committee staff interviewed several 

individuals within the Geriatric Psychiatry Branch run by Dr. Sunderland and found no 

support for his position regarding clerical malfeasance. 

When asked about his consulting conflicts of interest, Dr. Sunderland told OMA that 

“he had a consulting arrangement with Pfizer Corporate and the MTA with Pfizer 

researchers.” In fact, not only was the MTA and his initial consulting agreements signed 

by the same Pfizer official, Dr. Barrie Hesp, both contracts covered work directly related 

to the samples initially supplied under the MTA. (Exhibit 13) 

Dr. Sunderland further claimed that he sent human spinal fluid samples to Pfizer as 

he had to more than 30 other collaborators and that his collaboration with Pfizer would 

not have required visits to the company, as this was “an exchange of material for 

analytical data.” In fact, records show that Dr. Sunderland and his associate Karen 

Putnam visited the Pfizer facilities on a number of occasions to work on the data and, 

according to Dr. Friedman, at least once Dr. Sunderland accompanied Friedman and the 

spinal fluid samples on a plane to OGS in England. In addition to the Friedman interview 

information and several e-mails discussing trips to Pfizer in relation to the unknown 

biomarker work, both Karen Putnam and Pfizer informed Committee staff that Pfizer 

considered the primary data associated with the unknown biomarker project to be 

proprietary and could only be accessed on Pfizer property. (Exhibit 33) 

Another inconsistency with the relevant documents and the information conveyed by 

Pfizer regarding Dr. Sunderland’s consulting activities was Dr. Sunderland’s statement in 

the OMA interview that “his consulting work with Pfizer has to do with drug 

development and lectures.” Certainly lectures to audiences of doctors arranged by 

Pfizer’s marketing team charged with promoting Aricept accounted for substantial 

payments to Dr. Sunderland ($311,150 from 1996 to 2004 according to Pfizer) (Exhibit 

34) The consulting work involving the human tissue samples, however, was separate and 

apart from those lectures. (Exhibit 34) To the extent Dr. Sunderland meant that his 

“drug development” consulting was drug-specific, except perhaps for participation on 

various Pfizer-sponsored Advisory Boards relating to marketing strategy, Committee 

staff found little evidence from records or interviews that Dr. Sunderland’s consulting 

with Pfizer was related to any existing drug or drug under development. On the other 

hand, if Dr. Sunderland meant that his “drug development” consulting in a more general 

way applying to strategic advice to classes of medications, his attorney in a December 8, 
20

2004, letter to NIH distinguished this general consulting from his work on the “unknown 

biomarkers” project: “Generating new approaches to shorten the duration of clinical 

trials using various target markers is an obvious priority for companies like Pfizer, and 

Dr. Sunderland provided ongoing consultation about the development of such strategies. 

This consulting is quite different and separate from the exploration of peptide biomarkers

for possible diagnostic and prognostic use in Alzheimer’s disease.”16 (Emphasis added). 

Later in the same letter, Dr. Sunderland’s attorney described a reason for the April 1998 

MTA collaboration as “[p]roteomic exploration of CSF [cerebrospinal fluid] was 

designed to help discover peptide targets for drug development with both scientific and 

potential commercial applications.”17 (Emphasis added). 

During much of the time period (1998-2004) of Dr. Sunderland’s consulting with 

Pfizer, Ms. Karen Putnam was a 32-hour per week employee of NIMH assigned to Dr. 

Sunderland’s branch, although she was telecommuting from the University of Cincinnati 

where she was pursuing a graduate degree. (See Exhibit 11) According to e-mails, Dr. 

Sunderland urged Pfizer to hire Ms. Putnam to administer the database related to the 

unknown biomarker project. Pfizer tightly held the data from this “collaboration” so her 

work on that database had to be done at the company. Ms. Putnam performed a similar 

function with regard to the “known biomarkers” database. She informed the Committee 

staff that she understood that while the “unknown biomarkers” project was covered by 

her consulting agreement with Pfizer, the work she and Dr. Sunderland did with Pfizer on 

known biomarkers was a part of her official duties. Both biomarker projects started with 

consulting contracts between Pfizer and Dr. Sunderland, not independently and solely 

from NIH. 

During his OMA interview Dr. Sunderland was asked whether he told Karen 

Putnam that she did not have to seek approval for her work with him at Pfizer. In the 

signed interview notes Dr. Sunderland claimed not to remember if he told Ms. Putnam 

not to file, but he went on to state that he did not think she had to because she was a parttime employee on an IPA and because “her duties did not overlap with any decisions 

regarding drug or protocol development.” Ms. Putnam was a direct report to Dr. 

Sunderland and had received almost $65,000 in consulting fees and expenses from Pfizer 

to manage the data of the unknown biomarker study. (Exhibit 39). OMA found, and Ms. 

Putnam confirmed, that she had not submitted requests for outside activities. Exhibit 11. 

In addition, the NIH ethics review panel concluded that had Karen Putnam filed a request 

for outside activity the request would have been denied because it related to her official 

duties. (Exhibit 27) OMA noted in its review of Karen Putnam’s outside activities that 

in an e-mail to Ms. Putnam, dated June 18, 2004, the NIMH Ethics Coordinator stated 

that Dr. Sunderland had called from abroad to say that he had advised Ms. Putnam that 

she did not have to file for prior approval. 

Dr. Sunderland’s attorney in an August 31, 2004, letter to OMA stated: “There was 

no conflict between his consulting/lecturing and his clinical work at the NIH. . . “[He] 

never hid that relationship; and that there never was a conflict of interest – in any respect 

whatsoever – between his NIH work and what he did as a consultant and speaker for 

Pfizer. . . . The relevant facts are now before the NIH in their entirety.” The NIH Ethics 

Review Panel specifically found that there was “a direct overlap between the subject 

matter of Dr. Sunderland’s official area of research and the scientific subject matter of his 

Pfizer consultancies.” (Exhibit 35) He would not have been “given prior approval for the 

consultant activities.” The Ethics Panel “expressed further concern over the Material 

Transfer Agreement (MTA) that Dr. Sunderland entered into with Pfizer in 1998 while he 

maintained an ongoing consulting relationship with the company in the same area.” 

 

16 December 8, 2004, letter from Robert F. Muse, Esq. to Holli Beckerman Jaffe, Director, NIH 

Ethics Office, page 7. 

17 Id. , page 8. 
21

Based on records and interviews, Committee staff believes that NIH did not conduct 

interviews with Pfizer employees nor obtain from Pfizer the underlying records of Dr. 

Sunderland’s consulting agreements. Thus, even without the Pfizer documents and 

interviews that show connections between the MTA and the consulting, the Ethics 

Review Panel still concluded in April 2005 that there was a conflict of interest. 

Moreover, OMA believed that Dr. Sunderland did much of the Pfizer-paid work on 

government time. Dr. Sunderland acknowledged in the OMA interview that he never 

kept track of his leave time nor, as her supervisor at NIH, did he check to see if Ms. 

Putnam had taken leave when he signed her time cards. 

 Records and interviews also raised questions about Dr. Sunderland’s openness about 

the “unknown biomarkers” consulting agreement involving a third-party British company 

called OGS. For example, in her June 9, 1998, e-mail, Kathryn Smith noted to other 

Pfizer officers: “For your information, Dr. Trey Sunderland at NIH (our source for the 

AD samples) has requested that we do not mention him in any publicity concerning his 

involvement in our OGS collaboration.” (Exhibit 23). In addition, when the Committee 

first raised questions about the discrepancies involving Dr. Sunderland’s outside 

activities with Pfizer, the NIMH ethics coordinator in a June 18, 2004 e-mail to Dr. 

Sunderland asked directly: “There is a record of an MTA agreement with Pfizer signed 

4/98. Could payments have related to that?” (Exhibit 16) Based on records and 

interviews, there is no evidence that Dr. Sunderland responded to this question. It should 

also be noted that the terms of Dr. Sunderland’s consulting agreements state: “Pfizer 

agrees that it will not make public this agreement nor the terms associated with it.” 

Dr. Trey Sunderland is still an employee at the NIMH and is a member of Public 

Health Service Commissioned Corps. Administrative action rests with the Corps and not 

NIH per se. Dr. Thomas Insel, the Director of NIMH, forwarded a summary of the OMA 

findings and those of the Ethics Panel to the Commissioned Corps, noting that he was 

informed that civilian employees guilty of the same violations would be proposed for 

removal. In relevant part that document states: 

“Dr. Sunderland placed the NIH in a position where it had to respond to 

allegations of impropriety, which compromised faith in the Agency and trust in 

our research. 

Dr. Sunderland violated ethics rules with regard to his relationship with Pfizer 

and engaged in relationships with Pfizer and many other organizations that 

would not have been approved had he submitted them for approval in 

accordance with the process for seeking approval of outside activities...Not 

disclosing over $500,000 in income was not an oversight or lapse in judgment 

but appears to be a deliberate decision not to comply with the rules, policies and 

procedures that are necessary to protect the NIH, its scientists and most 

importantly, its science.” 

Question Three: Did the Committee’s investigation of the circumstances 

surrounding Dr. Sunderland’s transfer of human samples to Pfizer identify evidence 

that raised other compliance issues and policy questions? 

Finding/ Supporting Evidence: Yes. The investigation found reasonable grounds to 

believe there was questionable compliance with human subject protection and NIH 

technology transfer policies that existed at the time. The evidence also raised regulatory 

and ethical questions that are pertinent to NIH’s consideration of current policy related to 

human tissue samples. 
22

Discussion: 

Human subject protection 

A human subject is a living individual about whom a researcher (called an 

investigator) obtains either (1) data through intervention or interaction with the 

individual, or (2) identifiable private information.18 In the case study before the 

Subcommittee, Dr. Sunderland and other researchers collected spinal fluid by injecting 

the human subject with a needle at the base of the spine in a procedure called lumbar 

puncture (LP). According to the informed consent language in several of the protocols 

involved, this procedure is conducted in the morning, after the subject has had a night of 

bedrest. The subject lies on one side, the subject’s lower back is cleaned with antiseptic, 

and a local anesthetic such as novocaine is injected in order to temporarily numb a small 

area of skin. A needle is then placed into the spinal fluid sac, allowing an ounce of spinal 

fluid to drip into collection tubes. The needle is then removed and the subject is asked to 

lie on her/his abdomen for three hours to reduce the likelihood of developing a headache 

after this procedure. The LP procedure only takes 5-15 minutes. Most subjects 

experience only minor or moderate pain, similar to that experienced when an injection is 

received. 

The spinal fluid samples, usually collected in 20-30 cc amounts, are then alliquotted 

or subdivided into ten smaller tubes. Some small subset of the total amount is then used 

for the research study, with several other vials or test tubes of fluid left over, unused, 

stored in –70 degree centigrade freezers. 

Researchers at the NIH are responsible for protecting the rights and welfare of the 

human subjects who participate in their research. All intramural researchers at the NIH 

are responsible for knowing whether or not their research involves human subjects. 

Thus, legal obligations to protect human subjects apply to human tissue samples and 

private information, such as medical information, that can be readily identified with 

individuals. 

a. Questionable handling of informed consent. One issue presented by this matter 

involves the adequacy of informed consent for new, future uses of leftover human 

samples. The ethical foundation for informed consent is the principle of respect for 

persons, which requires that research subjects be given the opportunity to choose what 

shall and shall not happen to them.19 Valid informed consent requires disclosure of 

relevant information about the research, comprehension of the information by the 

prospective subject, and his or her voluntary agreement, free of coercion and undue 

influence, to participation.20

 In this case, Dr. Sunderland transferred spinal fluid samples to Pfizer that were 

collected from subjects whom most were told of the specific purpose of the particular 

research study being conducted, but not about the research purpose of the Pfizer 

collaboration, because in many cases that collaboration had not yet even been developed. 

At the time of collection, many of the spinal fluid samples were not obtained for the 

research purpose of the Pfizer collaboration. In general, there is a question about whether 

most of the protocols at issue had adequate informed consent language about consenting 

for future research uses of leftover samples.21 A few of the protocols involving the 

 

18 Title 45 Code of Federal Regulations, Part 46. 

19 National Commission for the Protection of Human Subjects of Biomedical and Behavioral 

Research. The Belmont Report: ethical principles for the protection of human subjects of research. 

Washington, D.C.:Government Printing Office, April 18, 1979. U.S. Department of Health and 

Human Services publication GPO 887-809. 

20 Position Statement, The Ethics and Humanities Subcommittee of the American Academy of 

Neurology, Neurology 1998, 50: 592-595. 

21 That silence or ambiguity would not have been unusual for most clinical research protocols 

because there had been no requirement to address future uses. It was not until January 2006 that the 

NIH Office of Human Subjects Research (OHSR) explicitly addressed this issue, revised its 
23

subjects are still ongoing and Dr. Sunderland actually sought Institutional Review Board 

(IRB) approval for amending these ongoing protocols to reflect the new research purpose 

involving Pfizer. 

Human subject protection regulations, however, state that unless the samples are 

anonymized and not linked to identifiable patients, the human tissue samples are not 

exempt from IRB review and some independent review (either from the IRB or the 

human subjects protection office of the institute or center) must be conducted to 

determine if full IRB review is needed and if so, whether the subjects need to be 

consented again for the new use.22 With respect to the samples transferred to Pfizer, NIH 

reported to Committee staff by e-mail that “[n]either the NIH OHSR [Office of Human 

Subjects Research] nor the NIMH [Institutional Review Board] have records 

documenting a review of the transfer to Pfizer.” According to NIH, “Dr. Sunderland has 

advised NIH that he believed at the time of the transfer that use of specimens in his 

collaboration with Pfizer, as described in the 1998 MTA, was completely consistent with 

both the protocols in which those samples were obtained, and the informed consent 

documents signed by participants.” 

But was it Dr. Sunderland’s judgment alone to determine whether the use of the 

samples was consistent with the protocols? Under the April 1995 Guidelines for the 

Conduct of Research Involving Human Subjects in effect at the time of the 1998 transfer, 

the use of human tissue samples were exempt from the NIH requirements on human 

research protection if the sources of pathological specimens “cannot be identified directly 

or through identifiers linked to the subjects.” The Guidelines also state in bolded print: 

“Investigators should not make determinations about exemptions without consulting 

OHSR.” 

The terms of 1998 Material Transfer Agreement (Exhibits 2 and 3) and the records 

produced by Pfizer relating to the samples provide reasonable grounds to believe that Dr. 

Sunderland intended to transfer, and actually transferred, coded clinical samples to Pfizer. 

Coded clinical samples are specimens supplied with a code rather than a name or social 

security number. Because these samples remain linked through codes to identifiable 

subjects, questions are raised over whether these samples would have been covered by 

human subject protection guidelines and whether Dr. Sunderland should have sought an 

independent consultation or determination.23 Currently, in light of concerns raised by the 

Committee’s investigation and at the direction of the NIH Deputy Director for Intramural 

 guidance, and issued “Sheet 14 Guidance on the Research Use of Stored Samples or Data.” In that 

guidance, researchers are required to submit a written protocol to an NIH IRB that includes a 

description of how samples will be tracked, how samples will be stored to be protected from loss or 

destruction, plans for samples at the conclusion of the protocol, and what circumstances would cause 

the lead researcher to report a loss or destruction of samples to the IRB. In discussion with 

Committee staff, the NIH Deputy Director of Intramural Research, whose office includes OHSR, 

stated that this revision occurred in response to the Committee’s investigation. 22 David B. Resnik, J.D., Ph.D., National Institute of Environmental Health Sciences (NIEHS) 

Bioethics Bulletin, “Human Research Q&A,” Spring 2005, at 2: 

 Question: “I have access to some leftover tissue samples from another investigator’s work. I 

would like to conduct some research on these samples. Is this research on a human subject? Do I 

need to submit a protocol to the NIEHS’s Institutional Review Board (IRB)? 

Short answer: This is not research on a human subject but you still need to contact the IRB before 

using these samples in research, since the samples were taken from human subjects.” 23 After several months of inquiries by Dr. Molchan, Dr. Sunderland sent 0.5 cc paired spinal-fluid 

samples from eight Alzheimer’s disease patients and two elderly normal volunteers to an outside 

researcher. In his interview with Committee staff, the Director of NIMH raised the issue of whether 

this transfer was in compliance with NIH guidelines along the same lines that questions had been 

raised by Dr. Sunderland’s transfer of samples to Pfizer. Dr. Molchan, however, told the Committee 

staff that the research purpose of the outside researcher was the same purpose (to conduct a lithium 

study) in the study she had not been able to complete. 
24

Research, an NIH investigation is being conducted to determine if Dr. Sunderland 

violated any regulatory or ethical standards in transferring spinal fluid samples to Pfizer 

without any IRB review from protocols that did not cover the research purpose in the 

Pfizer biomarker projects. 

b. Inadvertent disclosure of subject names and other privacy information. In 

reviewing records produced by Pfizer, Committee staff found that February-March 1999 

spreadsheet records for assays of two different potential biomarkers in 1999 contained the 

names of approximately 120 subjects who were the sources of the biological material, 

along with their codenames, NIH ID numbers, dates of birth, race, and sex. In 

consultation with Pfizer’s outside counsel, Committee staff confirmed that these records 

did indeed represent an inadvertent disclosure of subject names. According to Pfizer’s 

outside counsel in a March 31, 2006, letter to Committee staff, the spreadsheets contained 

information transcribed by Pfizer from labels on the vials sent by the NIMH. The 

samples were subsequently coded by Pfizer for analysis using the first three letters of the 

patient’s last name followed by the first three letters of the first name. The results of the 

study were included in the April 23, 2003, article in the Journal of American Medical 

Association as well as the analysis of a later set of samples. Subsequent samples arrived 

from the NIMH pre-coded using a numerical coding system. 

In response to the Committee staff’s question about Pfizer’s handling of this 

inadvertent disclosure, Pfizer’s outside counsel wrote: 

 “At the time that the NIH disclosure occurred, the Health Insurance Portability and 

Accountability Act (HIPAA), which established requirements regarding the use and 

disclosure of Protected Health Information, was not yet in effect, and thus there was no 

legal obligation imposed upon Pfizer to return or reject the information received. Even 

under the current HIPAA requirements, Pfizer’s research and development organization 

is not a ‘covered entity,’ and the duties imposed on such persons inadvertently receiving 

protected information are not clear. However, we believe Pfizer handled the inadvertent 

disclosure appropriately by creating an [sic] code to de-identify patients in the course of 

the research effort.”24

 There is no evidence that Pfizer contacted NIH about the inadvertent disclosure. 

There is no evidence that NIMH was aware of the inadvertent disclosure. If that was the 

case, NIH had no information to determine what led to the inadvertent disclosure, and 

was not in a position to correct a possibly recurring, systemic problem that increases the 

risk of inadvertent disclosure of privacy information. Further investigation would be 

needed to determine the circumstances that led to the inadvertent disclosure. 

 Committee staff understands from a discussion with NIH Acting Director for 

Human Research Protection that the release of patient names, whether accidental or not, 

is not consistent with NIH research standards and any manuscript in connection with the 

affected research project might not be published. This would need to be reported to the 

IRB, and to the NIH Deputy Director for Intramural Research. The NIH Deputy Director 

in turn might report this disclosure to the Office of Human Research Protection. 

c. Questionable non-disclosure of financial relationship to IRB. As part of his 

financial arrangement with Pfizer, Dr. Sunderland transferred spinal fluid samples to 

Pfizer from 1998 to 2004 for which he was paid $285,000 to advise Pfizer on data 

relating to the samples provided. According to NIH records, Dr. Sunderland provided 

 

24 Letter dated May 10, 2006, from Daniel A. Kracov, Esq., Arnold & Porter (on behalf of Pfizer, 

Inc.) to Committee staff. 
25

spinal fluid samples that had been collected from 14 different studies.25 Two of these 

studies were initiated in 2001 and 2002, respectively. In other words, Dr. Sunderland 

was performing lumbar punctures for spinal fluid at a time Pfizer wanted spinal fluid 

samples, and at a time Dr. Sunderland sought and received monetary compensation for 

his efforts to assist Pfizer in interpreting data generated from these spinal fluid samples 

he provided. In addition, while other studies no longer involved active collection of 

spinal fluid, these studies were still ongoing and were subject to continuing review by the 

NIMH IRB. As part of this continuing review process, Dr. Sunderland as the accountable 

investigator on the study had to check off “yes” or “no” responses to a series of questions 

on the NIH-1195 form, Clinical Research Protocol Continuing Review Application. The 

last question on the form was: “Have any investigators developed an equity or 

consultative relationship with a non-NIH source related to this protocol which might be 

considered a conflict of interest?” According to all forms related to spinal fluid protocols 

signed by Dr. Sunderland during the time he was consulting with Pfizer, the “no” box 

response was checked. (Exhibit 24) 

 Committee staff did not receive any records that linked the individual samples 

provided to Pfizer to specific protocol numbers. The 2001 study and the 2002 study, 

however, were identified as sources of spinal fluid samples to Pfizer. (Exhibit 26) Thus, 

while the Committee staff does not believe it has records linking the protocol number to a 

particular NIMH shipment to Pfizer, samples were provided to Pfizer from these studies 

in one of those years in which Dr. Sunderland represented to the IRB that he (or any other 

investigator associated with the study) had no outside financial interests related to the 

protocol. 

d. Cancellation of lithium study without notice to subjects. Dr. Molchan left 

NIMH in early 1997. By that time, Dr. Molchan had completed the spinal fluid 

collection phase of the lithium study a few years earlier. She was still, however, 

conducting the study and had used only a relatively small percentage of the samples. 

 Committee staff understands that sometimes when an NIH scientist in charge of a 

human subjects study leaves NIH, another NIH scientist is assigned to take charge of the 

study and the study is continued.26 When Dr. Molchan left NIMH, there was reason to 

believe (IRB approval, two papers published) the lithium study would be continued and 

that Dr. Sunderland as Branch Chief would either take over the study or assign someone 

to take over the study. Instead, the study was discontinued. Committee staff has asked 

NIH why the study was discontinued. To date, NIH has not provided a response on why 

this study was discontinued. 

 Committee staff has not found any evidence that the subjects in the lithium study 

were notified about the termination of a study. In these cases, where a clinical trial is 

terminated, the question is raised whether the subjects in that study should be notified of 

the termination. It is unclear how common it is for the written protocols of the clinical 

trial to include provisions about termination and notification. On the question of when a 

subject should be notified about termination of a study, an NIH official with expertise on 

human subjects protection told Committee staff that she believed that it depended on 

whether the study followed the subjects over a period of time. Nevertheless, the NIH 

Office of Intramural Research is working on a computer consent prototype and whether it 

should be a standard requirement to inform subjects of a study’s termination. 

 

25 The NIH recently advised the Committee staff that the internal NIH investigation on human 

subject research issues had identified 16 different studies connected to Dr. Sunderland’s transfer of 

human samples to Pfizer. 

26 For example, in 2005 Dr. Robert Cohen took over as the Principal Investigator for Dr. Sunderland 

in a few of the protocols involved as sources of spinal fluid for Pfizer. 
26

Technology Transfer Issues 

In pursuing its mission, NIH scientists often discover new technologies. The 

process of sharing these new technologies with other organizations and the public is 

called technology transfer. For example, the sharing of new research materials with 

colleagues, the pursuit of collaborative relationships with outside entities, and the 

awarding of intellectual property rights to commercial entities for development and 

commercialization, are all considered technology transfer activities. The NIH Office of 

Technology Transfer is responsible for developing and implementing technology transfer 

policies at NIH. Each Institute has a technology transfer office that monitors, evaluates, 

and manages the Institute’s invention portfolio. These offices review Employee 

Invention Reports (EIRs) and negotiate transactional agreements between the Institute 

and outside parties, including other Federal laboratories, State and local governments, 

universities, and pharmaceutical and biotechnology companies. Among these agreements 

are Material Transfer Agreements (MTAs) for the exchange of research materials, and 

Cooperative Research and Developments Agreements (CRADAs) for collaborative 

research endeavors. 

In this case, questions are raised in a number of areas about how NIMH at the time 

implemented technology transfer policies and the adequacy of certain technology transfer 

policies. 

a. Improperly authorized transfer. The transfer of spinal fluid samples was 

facilitated by the April 1998 Material Transfer Agreement between NIMH and Pfizer. 

The Committee’s investigation found two versions of the executed MTA. One version 

contained the signature of Dr. Sunderland as the provider of the samples on behalf of 

NIMH and the signatory for Pfizer, Dr. Barrie Hesp. (Exhibit 3) This is the only version 

of the MTA that Pfizer told the Committee staff it has. Committee staff found no 

evidence that Pfizer had any other version of the MTA. According to a Pfizer manager 

involved with the MTA, Pfizer made an effort to confirm that Dr. Sunderland had the 

authority.27 A March 1998 Pfizer e-mail does substantiate phone contact between the 

Pfizer manager and the NIMH technology transfer director about the MTA.28 Although 

she did not have specific recollection about the Pfizer phone call, the NIMH technology 

transfer director at the time (who has since left the NIH) told the Committee staff that she 

recalled getting phone calls about MTAs. These would not have been calls to receive 

official clearance but just preliminary inquiries. These kinds of calls were not 

documented. According to the official, she believed the Pfizer inquiry would have been 

about what form to use in transferring samples to Pfizer. She did not know that Dr. 

Sunderland and Pfizer were executing the MTA immediately. She expected to see the 

MTA and review it. There is, however, no evidence showing she received any Pfizer 

correspondence and was sent the MTA. She had no recollection about any mention of 

possible consulting, but even if it had been mentioned, she would have expected the 

ethics office to be involved in that review. The official disputes that she confirmed that 

 

27 May 10, 2006, letter from Daniel Kracov, Esq. to Committee staff: “In April 1998, what was 

Pfizer’s understanding of Dr. Sunderland’s authority to sign an MTA? In 1998, Pfizer sought to 

confirm Trey Sunderland’s authority to enter into the MTA on behalf of NIH. In this regard, 

Pfizer’s Kathy Smith was referred to Kathy Conn at NIH [the NIMH Director for Technology 

Transfer] who, to Kathy Smith’s recollection, confirmed that Dr. Sunderland was authorized to 

execute the agreement. It has been Pfizer’s standard practice when dealing with academic 

institutions, including institutions such as NIH, not to accept an investigator’s claim to have 

authority to sign an agreement without consulting with an appropriate representative of the 

contracting institution.” 

28 E-mail from Kathryn E. Monaghan [Smith] to Trey Sunderland, March 24, 1998: “Trey, I spoke 

with Kathy Conn today and she also reconfirmed that we can proceed with the MTA immediately 

and work out the CRADA vs. Consult part in due course. I fedexed various forms of the MTA on 

Friday -- hope you got them yesterday?” Exhibit 31. 
27

Dr. Sunderland was authorized to execute the agreement. Based on the phone call, the 

official expected to review the MTA and forward it to the NIMH Scientific Director for 

signature. The official’s recollection was that all transfers of human tissue samples 

to researchers outside NIH were documented through MTAs. 

In early 1999 during an office move, the NIMH technology transfer office staff 

discovered a number of MTAs that had not been co-signed by the NIMH Scientific 

Director, as required by the written delegations of authority in effect at the time. One of 

these MTAs was the Sunderland-Pfizer MTA. When these MTAs were brought to his 

attention, the NIMH Scientific Director co-signed. He co-signed the Pfizer MTA on 

February 24, 1999. At that time, NIMH had already made three shipments of spinal fluid 

to Pfizer. (Exhibit 3, p.3) The co-signed MTA was retained in NIMH files. According to 

NIH, there was no evidence that Dr. Sunderland was given a copy of the 1998 MTA after 

Dr. Desimone signed, and Dr. Sunderland told NIMH he did not get a copy of the cosigned MTA until about several months ago when he requested it from the NIMH 

Executive Officer.29 Moreover, it is unknown when Dr. Sunderland learned about the 

existence of the co-signed MTA. 

The available evidence shows that Pfizer only had the MTA with Dr. Sunderland’s 

signature. Under NIMH policy at the time, however, Dr. Sunderland was not the 

authorized signatory to execute the MTA. Questions arise about whether NIMH’s 

transfer of samples was legally authorized and the legal implications for NIH. 

Furthermore, available evidence shows that NIMH management did not provide the cosigned versions to either Dr. Sunderland or Pfizer. This is of concern because NIMH 

management should have an interest in correcting an internal problem of unauthorized or 

improperly authorized material transfers. The problem cannot be corrected if 

management does not make NIH scientists aware of the error. In a conversation with 

Committee staff, the former NIMH technology transfer director acknowledged that this 

was an oversight. 

b. Plasma samples transferred without MTA. According to records from Pfizer 

and others, NIMH shipped 388 plasma samples to Pfizer on August 19, 2002. The 

Committee has no records of a material transfer agreement covering these plasma 

samples. The April 1998 MTA and the October 6, 2000, amendment to this MTA only 

covered coded clinical samples of spinal fluid and serum.30 

c. Questionable amendment to MTA. The April 1998 MTA was executed using 

the Public Health Service Agreement MTA form and Dr. Sunderland was listed as the 

provider at his NIMH address. The October 6, 2000, amendment to the April 1998 MTA 

was executed on Pfizer letterhead and listed Dr. Sunderland at his home address. 

Committee staff asked NIH whether there were any amendments to the 1998 Pfizer 

MTA. NIH told the Committee staff that the NIMH Technology Transfer Office did not 

have an amendment but then NIMH asked Dr. Sunderland if there had been any 

amendments. At that point, Dr. Sunderland produced the October 2000 amendment. In 

an interview with Committee staff, the NIMH Technology Transfer Director stated that 

this amendment “would have raised eyebrows.” Even though NIH told the Committee 

staff that Dr. Sunderland had the signatory authority to execute an MTA in 2000, because 

Dr. Sunderland had executed the MTA and had it co-signed by the NIH Scientific 

Director, the same process of authorization in effect in 1998 should have been used for 

the amendment in 2000. 

 

29 E-mail from Gemma Flamberg (NIH) to Alan Slobodin (Committee staff), June 1, 2006. (Exhibit 

37) 

30 Pfizer, however, did not actually receive any serum from NIMH (March 31, 2006, letter from 

Daniel A. Kracov, Esq. to Committee staff). 
28

 d. NIMH policy on MTAs lacked basic controls of accountability. According to 

an NIH e-mail to Committee staff, Dr. Sunderland had the authority to transfer the spinal 

fluid samples to Pfizer on his own without any approval or reporting, as long as Dr. 

Sunderland chose not to document the transfer without an MTA. Because he chose to 

execute an MTA, however, he did not have authority on his own to provide the samples. 

He needed clearance from the NIH Scientific Director. In other words, NIMH policy at 

the time, as represented by NIH, gave scientists more authority to provide government 

property to non-government researchers without any paperwork than if the scientists 

chose to do the paperwork. This kind of system raises the question whether such a 

policy incentivized a lack of accountability. 

 Moreover, in 1999 the NIMH changed its written delegations of authority to 

permit Branch Chiefs, such as Dr. Sunderland, to have sign-off authority on MTAs. The 

stated rationale was to ensure that branch chiefs were aware of what materials were 

coming and going from the labs under their supervision. According to NIH in an e-mail 

to Committee staff, Dr. Sunderland had the authority after May 24, 1999 to approve his 

own transfers of material (including human tissue samples) outside NIH. This NIMH 

policy, or perhaps policy interpretation, raises the question about the lack of essential 

checks and balances to protect against fraud and error because the Branch Chief could 

approve his own MTAs for samples from studies in which he was involved as the 

Principal Investigator. 

 e. Lack of clarity in NIMH policy on MTAs. Committee staff found an 

information bulletin, “NIH Technology Transfer and You,” posted on the NIMH 

Technology Transfer Office (TTO) web site. The bulletin stated that that the NIMH 

version was revised on February 24, 2000. This bulletin stated in boldface type: 

Current NIH policy requires that MTAs be used whenever an NIH scientist 

sends out or receives materials, e.g., cDNAs, cell lines, antibodies, etc. These 

agreements must be signed by authorized IC personnel.

31

The NIMH TTO Director at that time told Committee staff in an interview that MTAs 

were required. Other NIMH officials and NIH, however, disputed that the policy was so 

clear-cut. Rather, scientists were encouraged to use MTAs but not required to do so. In 

other words, MTAs were discretionary. NIMH officials interviewed by Committee staff 

also were not familiar with the TTO Bulletin. This area raises a question about the 

adequacy and accuracy of internal communication at NIMH. There is also a question 

about what was the actual policy. 

 

f. The MTA was a questionable mechanism for the transfer. Committee staff 

obtained records showing that Dr. Sunderland was the provider of spinal fluid samples in 

a 1989 Cooperative Research and Development Agreement (CRADA) between NIMH 

and Abbott Laboratories. Under this CRADA, Dr. Sunderland provided 115 samples of 

spinal fluid to Abbott. NIH and NIMH officials could not distinguish between the Abbott 

transfer and the Pfizer transfer in terms of why a CRADA was used with the transfer to 

Abbott but not with the one to Pfizer in 1998. Moreover, at a 1999 NIH Conference on 

Biomarkers, Dr. Sunderland stated: “In a large-scale collaboration between the NIMH, 

Pfizer, and OGS, we have embarked on a series of studies focused on one very important 

part of biomarker puzzle,” and later stated that “cerebrospinal fluid markers are the focus 

of our collaborative efforts with Pfizer and OGS.”32 (Emphasis added). Given such 

 

31 (Exhibit 38) 

32 T. Sunderland, “Prospective search for Alzheimer’s disease (AD) biomarkers,” in Downing, ed., 

Biomarkers and Surrogate Endpoints: clinical research and applications, Proceedings of the NIHFDA Conference held on 15-16 April 1999 in Bethesda, Maryland, USA, at 39, 40 (Elsevier, 2000). 
29

characterizations33of the activity with Pfizer and OGS as well as other information, these 

officials believe that Dr. Sunderland and Pfizer were in fact engaged in a collaboration in 

which a CRADA would have been the appropriate mechanism to use. 

 g. Reference to third-party collaborator in MTA should have triggered more 

scrutiny. Provision #2 in the April 1998 MTA stated that: “The Research Material will 

only be used for research purposes by Recipient and Recipient’s collaborator in the UK, 

for the research projects described below, under suitable containment conditions.” The 

mention of the Recipient’s collaborator in the UK was a reference to Oxford 

Glycosciences, Ltd., (OGS), as part of the collaboration with Pfizer. OGS was part of the 

three-way collaboration with Pfizer and NIMH. OGS used 2D gel electrophoresis 

techniques to detect proteins in spinal fluid. OGS was not, however, specifically 

identified in the MTA. The involvement of a third-party collaborator raises a question of 

whether this was a modification of a routine material transfer and should have triggered 

further scrutiny from the Technology Transfer Office. The question is raised about 

whether uses and recipients of samples are adequately reported in the MTA and whether 

NIMH should have been made more aware of OGS and the use of the samples. 

Moreover, the MTA authorized the transfer of spinal fluid samples for the narrow 

purpose of the collaboration, which Pfizer refers to as the “unknown biomarker” projects. 

Records, however, produced to the Committee show that Dr. Sunderland provided over 

2,100 samples to Pfizer for the “known biomarker” project. OGS, however, was not 

involved in this collaboration and it was actually a separate biomarker research project. 

A question is further raised whether the 2100 samples sent to Pfizer for this project were 

entirely unauthorized. 

h. Most of the samples transferred to Pfizer may not have been covered by the 

MTA and the MTA amendment. As mentioned before, the terms of the MTA related 

to transfers for the research purpose of the three-way collaboration of NIMH, Pfizer, and 

OGS. Pfizer calls this collaboration the “unknown biomarkers” project. The second 

project between Dr. Sunderland and Pfizer, did not involve OGS and Pfizer calls this “the 

known biomarker project.” The NIH documents produced to the committee relating to 

the Pfizer collaboration state that the total number of samples sent to Pfizer equals 2132 

vials for beta-amyloid 1-42, beta-amyloid 1-40, and tau. These are known biomarkers and 

relate to the “known biomarker” project. One of the NIH documents asserts that the 

samples sent to Pfizer were “through the NIH-approved MTA.” The Committee, 

however, has not received any records of any MTA covering the known biomarker 

project. It is highly questionable whether NIH technology transfer and legal officials 

would find that the April 1998 MTA for the unknown biomarker project could be used to 

authorize transfer for the known biomarker project, even though it involved the same 

company and the same area of research, because the samples were used for a different 

research purpose. 

Science management concerns 

Three important concerns were raised: lack of retention of clinical research data, 

conflict of interest in committing NIH scientific resources, and NIH oversight of 

unpublished research. 

 a. Lack of retention of clinical research data. When Dr. Molchan inquired about 

getting the leftover spinal fluid samples, she also asked about getting the data from her 

uncompleted lithium study. Dr. Sunderland informed Dr. Molchan that this data was no 

longer available: 

 

 “Dear Sue, 

 

33Dr. Sunderland also highlighted this collaboration in a paper he prepared for a 2000 NIMH of 

Board of Scientific Counselors review of research in his branch. 
30

 Over the last few days, we have been searching electronic files and paper files to 

see what we could find. Unfortunately, the data is no longer available. Just so you know, 

we had to go through several purges over the last few years when we moved offices, and 

anything over 5-7 years old was subject to purging. Since these studies and the resultant 

publications go back over 15 years in some cases, they were not carried forward to our 

limited space. . . . “ (Trey Sunderland e-mail , March 14, 2005 to Susan Molchan). 

 Dr. Molchan raised the issue of data retention in an e-mail to Committee staff: 

“Does NIH have a policy on what happens to data like this when scientists leave the 

NIH? It seems wasteful to repeat the same studies without having earlier results.” 

 

 Two senior NIH officials provided somewhat conflicting information. One 

official confirmed the policy of purging clinical data after seven years. Another official, 

however, had never heard of such a policy. The Subcommittee may wish to raise this 

question with NIH about what the policy is, and what the policy should be, on retention 

of clinical research, particularly in cases where the researcher has left NIH. 

b. Commitment of resources. Dr. Sunderland’s collaborations with Pfizer resulted 

in the shipment of over 3,000 spinal fluid and plasma samples. These samples were 

extraordinarily valuable, both scientifically and commercially, because they contained 

useful information, they were linked to well-characterized clinical data (lots of medical 

details about the subjects), and the samples were taken from these same subjects over 

different points in time over several years. The Committee staff could find no evidence 

that showed in 1998 any NIMH official besides Dr. Sunderland who was even aware, 

much less supportive, of the merits of the Pfizer collaboration. Thus, Dr. Sunderland, 

while having concurrent financial interests with Pfizer, made the decision to commit 

3,000 non-renewable taxpayer-supported human research samples. 

Techniques employed in proteomic analysis are new and evolving. Even if Dr. 

Sunderland may have been the scientist in the best position to evaluate whether the OGS 

technology was promising enough to consume these valuable human tissue samples, the 

intramural research program at NIMH or NIH may have had more than one expert in 

proteomics to assist in such a decision. Could Dr. Sunderland’s scientific judgment have 

been better informed by consultations with other proteomic experts at NIH? The Pfizer 

projects may have been the most promising collaboration available in the search for 

biomarkers of Alzheimer’s disease. Could an exploration of other private sector or 

academic partners produced a more promising result? Most importantly should a single 

scientist be the sole decisionmaker about the best use of these unique human tissue 

samples, especially with direct financial interests involved? 

c. NIH oversight of unpublished research. In the year 2000, Dr. Sunderland 

prepared a document called “Overview - GPB,” in preparation for a review by the 

NIMH Board of Scientific Counselors. On page 3 of this document, the discussion about 

the Pfizer/OGS collaboration is as follows: 

“Perhaps the most interesting interaction is the three-way collaboration between the 

NIMH, Pfizer, Inc., and Oxford Glycosciences in England. This cooperative approach 

was first established in 1998 to investigate protein spots in the CSF of AD subjects and 

‘at risk’ controls at baseline and over time. While this convergence of government 

investigators, the pharmaceutical industry, and a biotechnology firm has been highlighted 

by the NIH Director at a recent national biomarkers meeting as a way to leverage 

resources and scientific interest in the future, the proof of its power must come from the 

data, especially over time. Using high-throughput, exquisitely sensitive 2D gel 

electrophoresis techniques which provide quantitative data reflecting the up- and downregulation of proteins in human CSF, we are generating cross-sectional data on over 1200 

proteins in groups of AD and ‘at risk’ subjects. Perhaps most importantly, we will have 
31

longitudinal data in both these groups through repeat CSF collections that will allow us to 

track protein changes through the evolution of this illness.” 

Under normal circumstances, the BSC would have been scheduled for another 

review of Dr. Sunderland’s work in 2005. However, because in late 2004, NIMH 

officials believed that Dr. Sunderland was going to be leaving the NIH the BSC review 

was cancelled. The Committee staff has not found any publications related to the 

Pfizer/OGS collaboration. When asked by Committee staff to retrieve data or some kind 

of workproduct that resulted from this collaboration, NIH was unable to do so. In an 

interview with Committee staff, Karen Putnam indicated that all data related to the 

unknown biomarker project was maintained on-site at Pfizer. As Ms. Putnam noted in 

her December 7, 2004, letter to NIH: 

“Pfizer asked me to consult in the fields of statistics and data management. I was 

involved in specific projects exploring proteomics and statistical methodology. The 

Pfizer activities centered around discovery research, where the results were used to 

generate future hypotheses and directions of research. The results generated from my 

Pfizer outside activities were not part of the data involved in my current government job. 

All proteomics data were confidential and kept at the Pfizer site. The computer software 

and hardware used in exploring proteomics data was located at the Pfizer site.” 

Outside counsel to Pfizer confirmed to Committee staff that this was essentially correct. 

Thus, the available evidence is that the unknown biomarkers project (or “discovery 

research” per Ms. Putnam) did not generate data that came into possession of the NIH. 

Under these particular circumstances, NIH was unable to report to the Committee what 

this collaboration had produced for NIH’s scientific research program. 

Conclusion 

 In sum, the records and interviews conducted in this investigation raise serious 

questions of misconduct in connection with, and inadequate oversight and control over, 

human tissue samples in NIH intramural programs. It should be noted that the Committee 

staff found no evidence that Pfizer had any knowledge relating to the questionable 

conduct of Dr. Sunderland in connection with the April 1998 MTA and the subsequent 

shipments of samples. Members of the Subcommittee may wish to pursue these 

questions at the hearing with witnesses and/or other appropriate action. 
32

Academic 

Advisory Boards

$6,000.00

1%

Pfizer Advisory 

Boards

~ $10,000.00

 2%

Consulting for 

Unknown 

Biomarkers

$160,000.00

 26%

Consulting for 

Known 

Biomarkers

$125,000.00

20%

Speaking

$311,150.00

51%

Pfizer Fees Paid to Dr. Trey Sunderland (1996-2004)

Total: Approximately $612,150.00

Fees Resulting from Human Samples Sent to Pfizer

[MAIN HEARING FOCUS] 

Consulting for 

Known 

Biomarkers

$125,000.00

20%

Consulting for 

Unknown 

Biomarkers

$160,000.00

 26%
33

25 

Total CSF Donors

25 

Total CSF Donors

10

Tapped Once*

10

Tapped Once*

15

Tapped Twice

15

Tapped Twice

10

Alzheimer’s

10

Alzheimer’s

5

Control

5

Control

3

Alzheimer’s

3

Alzheimer’s

7

Control

7

Control

Each Tap Yields Approximately 25 cc’s of CSF

• 10 Subjects @ 1 Tap ≈ 250 cc’s

• 15 Subjects @ 2 Taps ≈ 750 cc’s 

Total CSF Collected ≈ 1000 cc’s

Dr. Molchan Lithium Study

*Estimate based on assumption that subjects were tapped once

Total Collected Spinal Fluid for Lithium Study = 1000 cc’s

0

100

200

300

400

500

600

700

800

900

1000

What Sunderland

Provided in 2005

What Molchan Used by

1997 

Unaccounted for Samples
34

Dr. Sunderland’s Shipments of Spinal 

Fluid to Pfizer 

Shipment Date Number of Tubes Study

1 6/24/1998 6/24/1998 621 Unknown Biomarkers Unknown Biomarkers

2 2/9/1999 2/9/1999 280

3 2/22/1999 2/22/1999 55

4 3/24/1999 3/24/1999 491 Unknown Biomarkers Unknown Biomarkers

5 5/5/1999 5/5/1999 390

6 2/3/2000 2/3/2000 47

7 4/3/2001 4/3/2001 166 Unknown Biomarkers Unknown Biomarkers

8 12/1/2001 12/1/2001 264

9 8/19/2002 8/19/2002 105

10 8/11/2003 8/11/2003 349

11 Shipment 8 Transfer Shipment 8 Transfer 207 Useable 207 Useable

12 3/16/2004 3/16/2004 570

Total Tubes Shipped = 3245

Cost of collection to the NIH Cost of collection to the NIH

•To Collect CSF To Collect CSF

– 538 Subjects at about $12,000 each 538 Subjects at about $12,000 each

Total = Total = $6,456,000.00 $6,456,000.00
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 MR. WHITFIELD. At this time, we have about 4 minutes left to cast 

two votes on the House floor, so Dr. Molchan, I will apologize to you, 

but we are going to take a recess here, go vote, and then we will be right 

back. We look forward to your testimony as soon as we return. 

 So thank you. We will get your opening statement when we get 

back. 

 [Recess] 

 MR. WHITFIELD. I would like to reconvene this hearing, and we had 

indicated that we would have an opening statement from Ms. Baldwin 
158

when we resumed and she is not here, so at this time I would like to 

recognize Mr. Stearns of Florida for his opening statement. 

 MR. STEARNS. Thank you, Mr. Chairman. I certainly want to thank 

you for holding this hearing and your leadership here in prodding 

everyone to do this, today and tomorrow, surrounding the NIH policies 

on tissue samples. I also want to thank Dr. Molchan for testifying today 

and for the courage for coming to the subcommittee when you were 

troubled about this concern. 

 This hearing will ask if NIH has adequate policies in place to prevent 

diversion of human tissue samples for unauthorized purposes, and what 

is NIH policy on a chain of custody documenting human tissue samples 

from subject to each researcher that touches these samples, inside and out 

of NIH. Are we tracking the inventory or just willy-nilly sticking values 

on donations because this is what they are, a patient’s literal blood, 

sweat, and tears, in the freezer with no tracking, no checks, and no 

balances. In other words, where is the oversight, where is the 

accountability here? 

 This hearing raises the question about conflicts of interest at NIH, 

researchers involved in outside research assignments in industry. At the 

hearing in the summer of 2004, I was one who questioned Dr. 

Sunderland about a lucrative outside financial contract he had with 

Pfizer, and that now has surfaced again in this hearing. The extramural 

research that NIH funds and is supposed to oversee so carefully sends 

positive rippling effects across organizations, academia, and facilities 

across the United States. For example, Alzheimer’s disease, neuroimaging initiative, ADNI, for which the doctor as the program director 

relies on software-supported imaging equipment developed and 

manufactured by Siemens, Phillips, and General Electric. The three 

primary companies that develop and manufacture imaging are providing 

for the imaging aspects of the project, while the company that 

manufactures magnetic resonant imaging, the MRI coils that these giants 

of diagnostic imaging use, make them in Gainesville, Florida, in my 

congressional district. So many different people depend on the integrity 

of NIH human tissue policies, from patients hoping and praying for a 

cure for their disease to biotech companies to small engineering firms. 

 Lastly, another question they have about this hearing is when the 

research subjects submitted a specimen CFS, did they consent to just a 

single study or did some at the NIH think it was a blanket consent for 

multiple uses and/or free reign over their spinal fluids for various 

research studies? In answer to that, I am troubled that it seems some at 

NIH did, in fact, handle these CFS specimens carelessly, sending them 

unauthorized to Pfizer without de-identifying them. 
159

 Again, this committee has passed my data bill, H.R. 4127, which 

applies only to industry, but it sounds like we need to consider Federal 

agencies handling of Social Security and other sensitive personal data as 

well. 

 Mr. Chairman, I thank you for exploring these issues and I yield 

back. 

 [The prepared statement of Hon. Cliff Stearns follows:] 

PREPARED STATEMENT OF THE HON. CLIFF STEARNS, A REPRESENTATIVE IN CONGRESS 

FROM THE STATE OF FLORIDA

I want to thank Chairman Whitfield for holding this hearing today and tomorrow 

surrounding NIH policies on tissue samples. And Dr. Molchan, thank you for testifying 

today, and for your courage in coming to this Subcommittee when you were troubled. 

 This hearing will ask if NIH has adequate policies in place to prevent diversion of 

human tissue samples for unauthorized purposes? And, what is NIH’s policy on a chain 

of custody, documenting human tissue samples from subject to each researcher that 

touches it, inside and outside of the NIH? Are we tracking the inventory, or just willynilly, sticking valued donations, because that is what they are, of patient’s literal blood, 

sweat and tears, in the freezer with no tracking, no checks and balances? Where is the 

oversight, the accountability? 

 Also, this hearing raises questions about conflicts of interest of NIH researchers 

involved in outside research assignments in industry. At the hearing in the summer of 

2004, I was one who questioned Dr. Sunderland about a lucrative outside financial 

contract he had with Pfizer, that now surfaces again in this hearing. 

 The extramural research that NIH funds, and is supposed to oversee so carefully, 

sends positive rippling effects across organizations, academia, and facilities across the 

nation. For example, the Alzheimer’s Disease Neuroimaging Initiative (ADNI), for 

which Dr. Molchan is the program director, relies on software support and imaging 

equipment developed and manufactured by Siemens, Philips, and General Electric, the 

three primary companies that develop and manufacture imaging equipment. Well, the 

company that manufactures the magnetic resonance imaging (MRI) coils that these giants 

of diagnostic imaging use makes them in Gainesville, Florida: INVIVO Corporation. So, 

many different people depend upon the integrity of NIH’s human tissue policies, from 

patients hoping, praying for a cure for their disease, to biotech companies, to small 

engineering firms. 

 Another question I have about this hearing is when the research subjects submitted a 

specimen of cerebrospinal fluid (CSF), did they consent to just a single study, Dr. 

Mochan’s? Or did some at the NIH think that it was a blanket consent for multiple uses 

and/or free reign over their spinal fluid for various research studies? 

 And, advancing from that, I am troubled that it seems some at the NIH did in fact 

handle these CSF specimens carelessly, sending them, unauthorized, to Pfizer without deidentifying them! Again, this committee has passed my DATA bill, HR 4127, which 

applies only to industry, but it sounds like we need to consider federal agencies handling 

of Social Security numbers and other sensitive, personal data as well. 

Thank you for exploring these issues. 

 MR. WHITFIELD. Thank you, Mr. Stearns. 

 At this time I recognize Ms. Baldwin from Wisconsin. 

 MS. BALDWIN. Thank you, Mr. Chairman. 
160

 The NIH is one of our national treasures. The intramural research 

done at NIH and the extramural research done in cooperation with 

outside partners is truly amazing and sometimes awe-inspiring. So much 

of today’s most promising research involves human tissues. In order to 

translate biomedical discoveries into real improvements for people’s 

medical care, we must first use human tissues to test a treatment or 

develop a new theory about how a disease develops. The work that is 

done with these human tissues holds the potential to do so much to 

advance human health. 

 I am distressed to hear about apparent lapses in accountability with 

regard to human tissue samples collected at the NIH. Why doesn’t the 

NIH have a centralized system for tracking its tissue samples? Why is 

there no institute-wide inventory or accounting of what happens to these 

samples when a study ends? As our full committee and the 

Subcommittee on Health engage in discussions about health information 

technology, it seems like NIH could be a leader in this regard but at least 

in this arena, it certainly is not. 

 I think that what is most shocking to me is the carelessness and the 

way in which some at NIH appear to be treating such a precious 

commodity. While it is true that the samples are in freezers across the 

NIH and they might be vials of fluid or dishes of cells, it is important for 

us to remember that each of these samples originated in a person, and 

that person chose to share, chose to make a gift so that research could 

advance. At the very least, we must have practices in place that 

guarantee donor privacy and we need to ensure that donors are giving 

informed consent about how their donation will be used. 

 Lastly, a lot of these human tissues are non-renewable, and as I said 

earlier, they are a precious resource. We need to make sure that they are 

being used in the most appropriate and ethical way, not simply handed 

off to private companies. 

 Again, I am really shocked that some at the NIH would treat human 

tissues so carelessly, and that individual researchers would be given 

almost complete control over tissue samples without having to report to 

an impartial IRB, Institutional Review Board, like researchers at every 

academic research institution have to do. 

 I look forward to today’s discussion, and I hope this hearing will lead 

us towards some answers. I want to extend a special thank you to 

today’s witness, Dr. Molchan. I commend you for bringing information 

forward to this committee’s attention. 

 Thank you, Mr. Chairman. I yield back. 

 MR. WHITFIELD. Thank you. At this time, I will recognize the full 

committee Chairman, Mr. Barton of Texas. 
161

 CHAIRMAN BARTON. Thank you, Mr. Chairman, for holding this 

hearing. As I said at the last set of oversight hearings on NIH, the 

hallmark of this committee has always been its oversight responsibility 

and its willingness and ability to hold agencies responsible under its 

jurisdiction that produces results and better government and better 

services for the American people. 

 When we held oversight hearings about the NIH ethics system 

several years ago, we found that there were weaknesses in the system at 

that time, and that those weaknesses were more severe than we had 

previously recognized. To his credit, Dr. Zerhouni, who had a ringside 

seat at those hearings, took the facts of the hearing seriously and changed 

and reformed the NIH ethics system. 

 Today, we are going to take a look at how the NIH protects its most 

precious assets, that is, the material that is at the core of NIH research 

mission, human tissue samples. Once again, after extensive 

investigation, on a bipartisan basis, I might add, we have found deeper 

concerns regarding human tissue samples at NIH than we first believed. 

We have found a lack of a centralized database, lack of oversight. This 

lack of a centralized database and lack of oversight could, and probably 

does, leave NIH laboratories vulnerable to the risks of theft and abuse. 

We know from previous investigations that the NIH has an inventory 

system, but NIH tells us that it has no centralized inventory system that 

could tell the NIH director how many vials of tissues are in freezers at a 

particular institute. It would really be a shame if we find out that the 

National Institutes of Health has more control over its paperclips and 

trashcans than it has over its human tissue samples. 

 The committee has investigated a case and found evidence of a 

serious breach of trust. This case is focused on Dr. Trey Sunderland, 

who is supposed to be a witness later today in these hearings. He is a 

very noted, and I might add, respected researcher in the field of 

Alzheimer’s disease. I wish we were holding a hearing to congratulate 

him on some great discovery that he has made to cure or at least alleviate 

the hazards of Alzheimer’s. Instead, we are going to have to discuss a 

way of how he used his position to use NIH spinal fluid samples to 

further his own undisclosed personal consulting. The information 

provided so far to the committee shows that a private corporation, Pfizer 

Corporation, paid Dr. Sunderland $285,000 during the 1998-2003 time 

period to consult on two projects involving spinal fluid samples that Dr. 

Sunderland had sent to Pfizer. During the same time period, Pfizer also 

paid Dr. Sunderland approximately $300,000 for lectures. These figures 

don’t count an additional $200,000 for undisclosed activities with other 

companies. There is evidence that he advised his subordinate to conceal 

these consulting activities involving the samples. This is from an official 
162

who chaired for 10 years the committee that reviews the ethics of 

conducting mental health research on human beings. This certainly 

appears to be a betrayal of the public trust that NIH so much stands for. 

 These hearings underscore the need to enact NIH reauthorization and 

reform legislation. The NIH director must have some baseline of 

information about NIH assets if we are going to gain new efficiencies 

and hopefully more effective ways to translate research into better 

healthcare. NIH reauthorization legislation is of the highest importance. 

Out of this investigation, deserving questions and concerns, we can use 

these hearings to make NIH stronger and better. 

 The National Institutes of Health is, indeed, a national treasure. It 

must be cherished, protected, nourished, and allowed to flourish. 

Today’s hearing is a first step towards strengthening the public trust in 

NIH and preserving confidence in its integrity. I want to thank you, Mr. 

Chairman, and also the subcommittee Ranking Member, Mr. Stupak, for 

the bipartisanship nature of this investigation. I would also like to thank 

the Ranking Member of the full committee, Mr. Dingell of Michigan, for 

his support. 

 Finally, I want to say that I look forward to working with Dr. 

Zerhouni and others to improve in this area and to help NIH become 

better managed, and thus be able to deliver the results for the health of 

America that we so depend on NIH to do. 

 With that, Mr. Chairman, I yield back. 

 [The prepared statement of Hon. Joe Barton follows:] 

PREPARED STATEMENT OF THE HON. JOE BARTON, CHAIRMAN, COMMITTEE ON ENERGY 

AND COMMERCE

Mr. Chairman, I am glad you are holding these hearings. 

 As I said at the last set of NIH oversight hearings, I hope one of the hallmarks of my 

chairmanship of the Energy and Commerce Committee will be holding agencies 

responsible and produce better government and better services and policies for the 

American people. 

 Two years ago, when we held oversight hearings about the NIH ethics concerns, we 

discovered that the weaknesses in the NIH system were severe. Dr. Zerhouni, the 

Director of NIH, had a ringside seat and realized that NIH’s reputation was on the line. 

In light of our hearings, the NIH ethics system has been overhauled and reformed. 

 Today we look at how NIH protects precious assets, the human tissue samples that 

are at the core of the agency’s research mission. Once again, after extensive 

investigation, we have found deeper concerns regarding human tissue samples at NIH 

than first believed. Incredibly, we have found a lack of a centralized database and 

oversight at NIH that leaves NIH labs vulnerable to theft and abuse. We know from 

previous investigations that NIH has an inventory system for its property, but NIH tells 

us it has no centralized inventory system that could tell the NIH Director how many vials 

of tissue are in freezers at a particular institute. It appears that the agency can account for 

its paper clips better than its invaluable research material. 
163

 The Committee’s investigation has focused on one particularly brazen breach of 

trust. Dr. Trey Sunderland, a noted and respected researcher in the field of Alzheimer’s 

disease, has discovered something that may have been even more important to him. He 

has discovered how to make money by using NIH’s collection of spinal fluid samples in 

an undisclosed, personal consulting arrangement with a drug company. The information 

provided to the Committee is that Pfizer paid Dr. Sunderland $285,000 during the 1998-

2003 time period to consult on two projects involving spinal fluid samples Dr. 

Sunderland sent to Pfizer. During this same time period, Pfizer also paid Dr. Sunderland 

around $300,000 for lectures. He also earned almost $200,000 more for undisclosed 

activities with other companies. 

Dr. Sunderland might have been proud of his work, but he wasn’t. There is 

evidence that he advised his subordinate to conceal consulting activities involving the 

samples. All this from an official who for 10 years chaired a committee that reviews the 

ethics of conducting mental health research on human beings. Mr. Chairman, this 

amounts to a breathtaking betrayal of the public trust and of NIH values. 

 These hearings underscore the need to enact NIH reauthorization legislation. The 

NIH Director must have some baseline of information about NIH assets. If we are going 

to gain new efficiencies and hopefully more effective ways to translate research into 

better healthcare, enacting NIH reauthorization legislation is of great importance. 

 Out of this investigation of disturbing questions and concerns, we can use these 

hearings to make NIH stronger. NIH is indeed a national treasure. It must be cherished. 

Today’s hearings are a first step toward strengthening public trust in NIH research and 

preserving confidence in NIH’s integrity. 

 I thank you and Mr. Stupak for the bipartisan investigation. I also thank Mr. Dingell 

for his support of this investigation. Finally, I look forward to working with Dr. Zerhouni 

and the leadership of NIH on this matter and helping NIH become better managed and 

better able to improve the health of the American people. 

 MR. WHITFIELD. Thank you, Chairman Barton. 

 At this time I recognize Mr. Walden of Oregon for his opening 

statement. 

 MR. WALDEN. Mr. Chairman, I am going to waive an opening 

statement this afternoon. Thank you. 

 MR. WHITFIELD. Thank you. 

 Mrs. Blackburn of Tennessee. 

 MRS. BLACKBURN. Mr. Chairman, I will waive and reserve my time 

for questions. 

 [Additional statement submitted for the record follows:] 

PREPARED STATEMENT OF THE HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS 

FROM THE STATE OF COLORADO 

Mr. Chairman, thank you for holding this important hearing. The issue is not just 

about the alleged wrongdoing of one research scientist at the National Institutes of Health 

(NIH). The larger issue we face is the systemic breakdown in how we protect patients 

who courageously agree to participate in clinical research. The NIH is the premiere 

biomedical research entity in the world. As a result, it is imperative that the research 

protocols used by the NIH be of the highest integrity. Clearly, that is currently not the 

case. 
164

Let me first recognize our witness today, Dr. Susan Molchan, who brought this issue 

to the attention of the subcommittee. I believe we all owe you a debt of gratitude for 

coming forward. 

Tomorrow we will hear from a number of witnesses from the NIH. The 

subcommittee’s staff report raises many issues that our NIH witnesses must answer and I 

look forward to questioning the agency tomorrow about a number of my concerns. 

Specifically, I am concerned that it appears as though the NIH cannot account 

properly for human tissue samples in its possession or for the data generated by the use of 

those samples in biomedical studies. 

I would posit that the oversight function at NIH is in need of serious repair. Its 

investigatory ability is clearly inadequate when this Subcommittee has to uncover what 

the NIH cannot, even when it is trying. I sincerely hope that these hearings will assist the 

agency in straightening up the mess caused by its administrative shortcomings, just as our 

last hearings helped the NIH shore up its ethical standards. 

When he was shown the extent of the ethical loopholes at his agency, NIH Director 

Dr. Zerhouni was very responsive. I have no doubt that he will be equally responsive in 

addressing the travesty created by the lack of accountability that this inquiry has 

uncovered. 

All that said, what is most worrisome to me is the abuse of patients’ trust. These 

people, victims of Alzheimer’s Disease or their relatives, as well as some courageous 

individuals who have participated in the control groups, have submitted periodically for a 

decade or more to time consuming and painful spinal taps. They believed that the 

decisions regarding the use of these samples were made by the best scientific judgment in 

the country. 

It is possible that only such an esteemed institution as the NIH could have enlisted 

these volunteers and convinced them to return again and again to give spinal fluid. Yet, 

we now know that some of these committed patients were never told that the experiments 

that used their samples had been aborted. Others were never given the results of 

completed efforts. Nobody was informed that samples left over from certain experiments 

were shipped from the NIH to private drug companies. Patients were not informed that 

there was a chance that their names, names that were supposed to be divorced from the 

samples in the event of them being used for research, could be inadvertently revealed. 

This did in fact occur when one of the Sunderland shipments to Pfizer revealed patient 

names to company researchers. 

Mr. Chairman, these practices are unacceptable. Human subjects and their donated 

tissues simply must be protected as a first order of business by government researchers. 

The officials at NIH must be able to give ironclad assurances to these volunteers. To 

solicit cooperation and to take human tissue without proper protections in place is simply 

wrong, whether it is at the NIH or anywhere else. 

Last week, I introduced H.R. 5578, the “Protection for Participants in Research Act 

of 2006” to provide clear and consistent protections for human subjects who take part in 

clinical trials, as well as providing clear guidelines to those conducting medical research. 

Specifically, this measure strengthens patients’ rights to informed consent before 

subjecting to human subjects research. Perhaps this bill, given what we hear today and 

tomorrow from our panelists, could be used as a basis for further protecting human 

subjects, whether it is at the NIH, in universities, or at private companies. 

I yield back the balance of my time. 

 MR. WHITFIELD. Thank you. That concludes our opening 

statements, and at this time, Dr. Molchan, we will call you as our first 

and only witness of the day. 
165

 Dr. Susan Molchan is the Program Director of the AD NeuroImaging 

Initiative, Neuroscience and Neuropsychology of the Aging program at 

the National Institute on Aging. Dr. Molchan, as you may or may not 

know, in the Oversight and Investigations Subcommittee, we do have, as 

a matter of policy, to take testimony under oath. I would ask you, do you 

have any objection to testifying under oath today? 

 DR. MOLCHAN. No, I don’t. That is fine. 

 MR. WHITFIELD. Okay. Under the rules of the House and also the 

rules of the committee, you are entitled to be advised by legal counsel. 

Do you have legal counsel with you today? 

 DR. MOLCHAN. No, I don’t. 

 MR. WHITFIELD. You are on your own? 

 DR. MOLCHAN. Yeah. 

 MR. WHITFIELD. If you would stand, I would like to swear you in. 

 [Witness sworn] 

 MR. WHITFIELD. Thank you. You are now under oath, Dr. 

Molchan, and at this time I recognize you for 5 minutes for your opening 

statement. 

STATEMENT OF SUSAN MOLCHAN, M.D., PROGRAM 

DIRECTOR, AD NEUROIMAGING INITIATIVE, 

NEUROSCIENCE AND NEUROPSYCHOLOGY OF AGING 

PROGRAM, NATIONAL INSTITUTE ON AGING, 

NATIONAL INSTITUES OF HEALTH, U.S. DEPARTMENT 

OF HEALTH AND HUMAN SERVICES 

 DR. MOLCHAN. Thank you, Mr. Chairman. Mr. Chairman and 

members of the committee, my name is Dr. Susan Molchan from the 

National Institute on Aging at the NIH where I have worked since 2001 

as the Program Director for clinical studies and Alzheimer’s disease. I 

serve as a medical officer in the Commissioned Corps of the United 

States Public Health Service. Thank you for this opportunity to 

participate today. I have been asked to address my experience with 

human tissue samples at the National Institute of Mental Health where I 

worked for 9 years. I will address my experience specifically with one 

type of especially precious sample, spinal fluid, that I collected from a 

number of patients with Alzheimer’s disease and volunteers in the early 

‘90s. 

 As a young scientist at the NIMH, National Institute of Mental 

Health, I conceived and conducted a study that now has implications for 

Alzheimer’s research. In the process of my research, I obtained a very 

valuable material, spinal fluid. These samples can be obtained only with 

the consent and understanding of each and every patient. As a doctor, 
166

my first obligation is to advocate for patients who put their trust in me. 

Some of these patients had contributed their time and bodies to a number 

of my research studies and others at the NIMH. These good people are 

always ready to help and work on Alzheimer’s in any way my colleagues 

and I asked. 

 While at NIMH, a redirection of the program occurred. New goals 

made it impossible for me to continue my work. Lack of support was 

intense and I was not encouraged to stay, so I went to work at the FDA 

for a few years until 2001, when I was recruited to my current position as 

a program officer at the National Institute on Aging where I work with 

Alzheimer’s scientists throughout the country. 

 In 2004, some of these scientists, university scientists who are 

leaders of the National Institute of Aging’s clinical trials consortium 

where I work now, which serves as the primary mechanism through 

which NIH funds studies on the treatment of Alzheimer’s disease, 

proposed a study very similar to the one I had done while at the National 

Institute of Mental Health. Several of my very esteemed colleagues 

pressed me to obtain the samples I had collected. Such samples can be 

stored in freezers for years, and my colleagues and I had every reason to 

believe that they would still be available. 

 The head of the branch where I worked at NIMH located and sent a 

small subset of the spinal fluid samples to a university colleague for 

analysis. Twenty-five people had participated in the study, although I 

couldn’t recall on how many I had collected spinal fluid for sure. Some 

got one spinal tap, others had gotten two. I did know I had collected it 

on more than the eight Alzheimer’s patients and two volunteers on 

whose fluid was located. The individual responsible for the samples at 

the NIMH, Dr. Sunderland, e-mailed me that some of the samples had 

been lost in freezer thaw problems. A request to inspect the freezers to 

hopefully help find some samples was denied. 

 By the end of January 2005, intriguing data resulted from analyses of 

the spinal fluid samples that we were able to recover. Incomplete as it 

was, it contributed to the success of a grant proposal that shows promise 

in advancing knowledge on the mechanisms and treatment of 

Alzheimer’s disease. Several colleagues agreed that the data from these 

samples were worth publishing in a scientific journal. These senior 

Alzheimer’s researchers again pressed me for an answer as to why only a 

small amount of fluid was available, and only on a subset of the 

participants. This would need to be explained in any scientific 

submission of the data. 

 Since Congress had shown an interest in this matter, some progress 

has been made. I thank you for your interest in human tissue specimens 

that are so important to public health research. 
167

 Thank you. 

 [The prepared statement of Susan Molchan follows:] 

PREPARED STATEMENT OF SUSAN MOLCHAN, M.D., PROGRAM DIRECTOR, AD

NEUROIMAGING INITIATIVE, NEUROSCIENCE AND NEUROPSYCHOLOGY OF AGING PROGRAM,

NATIONAL INSTITUTE ON AGING, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES

Mr. Chairman and Members of the Committee: 

My name is Dr. Susan Molchan, from the National Institute on Aging (NIA) at the 

National Institutes of Health (NIH), where I have worked since 2001 as a program 

director for clinical studies on Alzheimer’s disease. I serve as a medical officer in the 

U.S. Public Health Service. Thank you for this opportunity to participate today. 

 I have been asked to address my experience with human tissue samples at the 

National Institute of Mental Health (NIMH), where I worked for nine years. I will 

address my experience specifically with one type of especially precious sample—spinal 

fluid— that I collected from a number of patients with Alzheimer’s disease (AD) and 

volunteers in the early 1990s. 

 As a young scientist at NIMH, I conceived and conducted a study that now has 

implications for AD research. In the process of my research, I obtained very valuable 

material—spinal fluid. These human samples can be obtained only with the consent and 

understanding of each and every patient. Those who participate in our research trust that 

their fluid specimens will be handled carefully. As scientists, we carefully document and 

store this material. 

As a doctor, my very first obligation is to advocate for the well-being and intentions 

of the patients who put their trust in me. Some of these patients had contributed their time 

and bodies to a number of my research studies and others at the NIMH. These good 

people were always ready to help in work on AD in any way my colleagues and I asked. 

While at NIMH, a redirection of the program occurred and the new goals made it 

impossible for me to continue my work. Lack of support was intense for this project and I 

was not encouraged to stay. I went to work at the FDA for a few years, until 2001, when I 

was recruited to my current position as a program officer at NIA, where I work with AD 

scientists throughout the country. 

In 2004, the university scientists who are the leaders of the NIA’s clinical trials 

consortium, which serves as the primary mechanism through which NIH funds studies on 

the treatment of AD, proposed a study very similar to the one I had done at the NIMH. 

Several of my esteemed colleagues pressed me to obtain the samples I had collected. 

Such samples can be stored in freezers for years, and my colleagues and I had every 

reason to believe that they would still be available. 

As research on AD has progressed, the need for spinal fluid samples has increased, 

as they may shed light on treatment options for this increasingly prevalent and 

devastating disease. All available scientific resources are needed to fight AD. 

The head of the branch where I had worked at NIMH located and sent a small subset (one cc per individual participant of the approximately 50 cc that I’d collected from 

each) of the spinal fluid samples to a university colleague for analyses (tests that were 

covered on the consent form under which study participants allowed me to collect their 

samples). 

Twenty-five people had participated in the study as documented on a Continuing 

Review memo to the NIMH IRB, dated July 1, 1993. Although I hadn’t collected spinal 

fluid on all of them, I had collected it on more than the 8 AD patients and two volunteers 

on whom fluid was located. The individual responsible for the samples at the NIMH 
168

emailed me that some of the samples had been lost in “freezer thaw problems.” A request 

to inspect the freezers to hopefully find some samples was denied. 

By the end of January, 2005 intriguing data resulted from analyses of the spinal fluid 

samples that we were able to recover. Incomplete as it was, it contributed to the success 

of a grant proposal that shows promise in advancing knowledge on the mechanisms and 

treatment of AD. 

Several colleagues agreed the data from these samples were worth publishing in a 

scientific journal. These senior AD researchers pressed me for an answer as to why only a 

small amount of fluid was available, and on only a subset of the participants. This would 

need to be explained in any scientific submission of the data. 

 Since Congress has shown an interest in this matter, some progress has been made. I 

thank you for your interest in human tissue specimens that are so important to public 

health research. 

 MR. WHITFIELD. Dr. Molchan, thank you very much for cooperating 

with the committee and your willingness to come and testify. 

 How long were you actually at the National Institute of Mental 

Health? 

 DR. MOLCHAN. I worked at the National Institute of Mental Health 

for 9 years, from 1987 to 1996. 

 MR. WHITFIELD. Eighty-seven to ‘96, and was Dr. Sunderland there 

during that entire period? 

 DR. MOLCHAN. Yes, he was always my supervisor, yes. 

 MR. WHITFIELD. Okay, before I get to the lithium study, just to 

clarify here, when we talk about human tissue, and when we look at the 

specific testing that you were involved in, we are talking about spinal 

fluid? 

 DR. MOLCHAN. Yes. 

 MR. WHITFIELD. But when we talk about human tissue in general, 

we are talking about things like subcellular DNA, we are talking about 

tissues like skin. 

 DR. MOLCHAN. Anything that comes from body parts. Blood is a 

tissue, for example, spinal fluid is a tissue, as are the more solid-- 

 MR. WHITFIELD. Okay. 

 DR. MOLCHAN. --components like skin. 

 MR. WHITFIELD. And fetal tissue, all of those things? 

 DR. MOLCHAN. Yes. 

 MR. WHITFIELD. Okay. Now, the lithium study that you were 

involved in, were you responsible for obtaining the spinal fluid for that 

study? 

 DR. MOLCHAN. I was responsible for obtaining most of the samples. 

The study was initiated by me and if it was going to get done, I was the 

one who had to do it. So I obtained most of the samples, though when I 

had to be somewhere else colleagues would step in and do so. 
169

 MR. WHITFIELD. And you said that the samples came from some 

Alzheimer’s patients, as well as two patients who had no medical 

problems? 

 DR. MOLCHAN. The subset of the samples that were located last 

year, right. There were several Alzheimer’s patients, eight Alzheimer’s 

patients and two of the normal volunteers that had done the study. 

 MR. WHITFIELD. So when you are dealing with an Alzheimer’s 

patient, how do you obtain their consent for a spinal tap? 

 DR. MOLCHAN. We did have procedures, clear procedures in place 

for that and they would co-sign, have a spouse or someone else 

responsible co-sign and understand. 

 MR. WHITFIELD. And what was the total volume of spinal fluid that 

you were able to collect? 

 DR. MOLCHAN. Generally we collected approximately 25 cc’s or 25 

milliliters, which is about five teaspoons. 

 MR. WHITFIELD. And that is from each person? 

 DR. MOLCHAN. That is from each person during one spinal tap, yes. 

 MR. WHITFIELD. And you had a total of nine or so patients that you 

obtained 25 cc’s from? 

 DR. MOLCHAN. There were more than that, and what was important 

about this study that I had done is we were able to get two spinal taps on 

people, one while they were taking medication and the other when not on 

the medication so we could compare. 

 MR. WHITFIELD. Okay. So anyway, you used a small amount of this 

fluid for your research, and then you left the National Institute of Mental 

Health and went to FDA? 

 DR. MOLCHAN. Yes. 

 MR. WHITFIELD. And then when you went over to the National 

Institute of Aging, a similar study came up and so you thought well, it 

will be great to go back and get to this spinal fluid? 

 DR. MOLCHAN. Yes. 

 MR. WHITFIELD. And so you went to see Dr. Sunderland about the 

availability, I am assuming, or you talked to him or you made inquiry? 

 DR. MOLCHAN. Well, I inquired through one of my former NIMH 

collaborators originally who was still at the NIMH to inquire for me. I 

followed up later with Dr. Sunderland by e-mail, I believe. 

 MR. WHITFIELD. Because he was the person-- 

 DR. MOLCHAN. Responsible-- 

 MR. WHITFIELD. --responsible-- 

 DR. MOLCHAN. --for them. Since he was the chief of the program 

there, the chief of the lab, yes. 

 MR. WHITFIELD. And so were you able to obtain samples from him? 
170

 DR. MOLCHAN. He did send samples from eight of the patients, 

eight of the Alzheimer’s patients, two of the normals, but only half a cc 

from each spinal tap, half a cc out of 25 cc’s. Now, I understand we 

didn’t need a whole lot, but we would have liked a little more than a half 

of a cc, but when we asked for a little bit more or what happened to the 

rest of it, we just never got any good documentation of that. 

 MR. WHITFIELD. Okay. So you never did find out how much they 

had? Did they give you any explanation of where it was or anything? 

 DR. MOLCHAN. Just that some of it had been lost in freezer failures, 

freezer thaws, and that it has been a long time. So no, nothing solid, 

nothing that made sense, because I knew the recordkeeping where this 

was done was very careful. The spinal fluid is very important stuff for 

our research and Dr. Sunderland was always very careful about 

documenting how much we had and the research assistants would know 

in what freezers and what part of the--you know, whether it was 

collected late or early in the spinal tap. It is very detailed information. 

 MR. WHITFIELD. So as you sit here today, do you know for a fact 

what happened to it? 

 DR. MOLCHAN. No. 

 MR. WHITFIELD. You still do not know, okay. 

 DR. MOLCHAN. No. 

 MR. WHITFIELD. Okay. Now, you were at two institutes at NIH, 

and was there a protocol, a policy on the collecting, the storing, the 

tracing, the using of human tissue samples? 

 DR. MOLCHAN. Well, where I am now in the extramural program 

which deals with the university researchers, you know, helping to 

administrate and plan Alzheimer’s research among the university 

community, whereas the intramural program does actual hands-on 

research, which I was in when I was in the National Institute of Mental 

Health. At that point, yeah, I just don’t know. I wouldn’t know about it. 

I think you are talking about the intramural program specifically, and I 

didn’t know when I was there. 

 MR. WHITFIELD. But you obviously were surprised that you were 

not able to obtain any information about the availability of spinal fluid? 

 DR. MOLCHAN. Yes. 

 MR. WHITFIELD. And that you were not able to get the volume that 

you really needed to-- 

 DR. MOLCHAN. Yes. 

 MR. WHITFIELD. --for your purposes? 

 DR. MOLCHAN. Yes, and I couldn’t understand that. 

 MR. WHITFIELD. Now, did the people that you reported to at the 

National Institute of Aging, did you tell them about it and did they go to 

Dr. Sunderland about this issue, or was it just dropped? 
171

 DR. MOLCHAN. I tried to keep it within the National Institute of 

Mental Health, so I did mention it to my colleagues at Aging, but again, 

this was a separate time and place when I was at the NIMH. It is an 

intramural program working specifically with Dr. Sunderland, so while I 

let them know about it, I didn’t expect or ask them to do anything. I told 

them I was following up with Dr. Insel and some other people. 

 MR. WHITFIELD. Now, at the time that you were at the Mental 

Health Institute, were you aware of scientists who had outside consulting 

agreements with-- 

 DR. MOLCHAN. Yeah. 

 MR. WHITFIELD. So that was not anything unusual about having 

these consulting agreements? 

 DR. MOLCHAN. I don’t have enough information to know how 

common or usual it was, but I know people did it and that there were 

ways to go about doing it. 

 MR. WHITFIELD. But you are not familiar with the disclosure 

requirements or anything like that, is that correct? 

 DR. MOLCHAN. For me with the intramural program at NIMH, these 

procedures have been evolving, these relationships between academia 

and industry, which I reiterate can be very positive if done in the right 

way. So I wasn’t involved in any myself, I was busy enough with my 

work at the NIH so I never looked into the rules of it seriously. 

 MR. WHITFIELD. Well, from the knowledge and experience that you 

have had working there and your professional occupation as a physician 

and scientist, would you agree with the statement that the protocol in 

place for tracking and collecting and using human tissues leaves 

something to be desired at NIH or do you have enough information? 

 DR. MOLCHAN. Well, just from my experience, it apparently did. I 

mean, I hope this is an unusual--I think it is an unusual situation and 

otherwise, it is outside of my sphere of experience as to what an overall 

policy is there. I would have to confer with other people. 

 MR. WHITFIELD. Now, tell me, who is Karen Putnam? 

 DR. MOLCHAN. Karen Putnam, she worked with Dr. Sunderland for 

many years as a research assistant. She was, I believe--I don’t know if 

she was a master’s degree level. She helped with everything from doing 

neuropsychological testing on people to inputting data to helping 

organize data, just kind of keeping track of things in general. So she was 

a research assistant. 

 MR. WHITFIELD. And did you work with her on trying to obtain 

these samples? 

 DR. MOLCHAN. No. Karen, as far as I knew, had left the NIMH a 

few years ago, though she may have still been doing some consulting. I 

don’t know. I really wasn’t in touch with them. 
172

 MR. WHITFIELD. Okay. 

 My time is expired. Mr. Stupak? 

 MR. STUPAK. Thank you, Mr. Chairman. Doctor, thanks for 

appearing today. 

 You said Dr. Sunderland was your supervisor? 

 DR. MOLCHAN. Yes. 

 MR. STUPAK. When you drew these samples, these cerebral spinal 

fluid, did he supervise that withdrawing of these samples? 

 DR. MOLCHAN. No. 

 MR. STUPAK. Okay. 

 You indicated in a statement to the Chairman that sometimes your 

colleagues would step in and draw some of these samples for you, 

correct? 

 DR. MOLCHAN. Yes. 

 MR. STUPAK. Okay. Is there any way that Dr. Sunderland or 

someone else then could say that they sort of had ownership of these 

samples because they drew them? 

 DR. MOLCHAN. I have never heard of such a thing. From what I 

understood when I left and otherwise, the samples belonged to the 

Government. I don’t think anybody would. 

 MR. STUPAK. So in this informed consent from these donors, did it 

identify the owner of the sample then being the NIH or NIMH? 

 DR. MOLCHAN. I would have to look at the language specifically, 

but again, that is such a broad question that we don’t usually get into the 

details of. I guess most of us just assume that it belongs to the NIH, the 

government. 

 MR. STUPAK. You said you left NIMH and when you left, was your 

study supposed to continue or did it stop or what happened there? 

 DR. MOLCHAN. I assumed it would continue. When other doctors 

left, especially with clinical studies where patients had been involved, the 

studies were continued, the data analyzed and then written up and 

published. 

 MR. STUPAK. Sure. 

 DR. MOLCHAN. So I assumed that the people who were following on 

where my position was would continue it, but apparently that didn’t 

happen. 

 MR. STUPAK. Do you know why your study stopped? 

 DR. MOLCHAN. I don’t, no. 

 MR. STUPAK. Okay. 

 DR. MOLCHAN. Why it wasn’t followed up, no. 

 MR. STUPAK. And you can’t recite for us what the proper protocol 

or policy was on releasing any of these samples at NIMH then, the 
173

samples you drew? Is there a certain procedure you have to follow 

before you release the samples? Say you release it to Pfizer-- 

 DR. MOLCHAN. The only samples I used were with a scientific 

collaborator within the NIH and to look at the samples as stipulated in 

the consent form to look at the effects of this drug, on and off the drug, 

so that was the only experience I had. It was all within the NIH. Other 

than that, I drew the samples and put them in the freezer and the research 

assistants would catalog them. 

 MR. STUPAK. And before you would release it to collaborative effort 

to work with somebody else, whether academia or whatever it is, you 

would know how much of the sample was sent, how much was 

requested-- 

 DR. MOLCHAN. Yes. 

 MR. STUPAK. --and the manner or method in which it was going to 

be used? 

 DR. MOLCHAN. Very much so. It was very specific. Depending on 

what you measure, you need certain amounts. I mean, sometimes you 

just need a tiny--you know, a drop, other times you might need as much 

as a few cc’s, half a teaspoon. 

 MR. STUPAK. Okay. When you were at NIH or the National 

Institute of Mental Health and you went over to the Institute on Aging, 

was it necessary or were you required to get any new consent forms from 

any of the donors as these samples were now being used in a different 

part of the agency than which was originally drawn for? 

 DR. MOLCHAN. Well, again, the samples were collected in an 

intramural program. I am in the extramural program. I don’t know if--I 

knew what we were interested in was covered in the consent form, 

because we wanted to look at the effects of the drug on the paired 

samples. And other than that we did academic circles, which in the past 

have been commonly done. People would make an agreement and I will 

send you so much and do such and such on it, and then send you the 

information, send you the data. 

 MR. STUPAK. If you can answer this one, if Dr. Sunderland teamed 

up with Pfizer to do some research outside of NIH for Pfizer’s benefit, 

when a sample is given from a donor, it is for research purposes, so could 

the research being done by Pfizer meet the definition in that consent 

agreement, or is the focus of the consent agreement from the donor that 

the ownership control use is for the government and not for outside? 

 DR. MOLCHAN. Well, there are mechanisms to have a 

pharmaceutical company or a biotech company do an assay for you, and 

in exchange for doing the assay--I mean, some of these are very 

expensive to do, so it actually can be very helpful. 
174

 MR. STUPAK. So the issue here really is not how the sample might 

have been used, whether internally or externally, but the lack of 

knowledge or-- 

 DR. MOLCHAN. Well, their samples--the way they are collected, the 

reason was to look at the effects of this drug on some of the proteins, 

some of the things we could measure in the spinal fluid. It is very 

specific to the actions of this drug, which has become of more interest 

recently in Alzheimer’s research. So that was very specific. 

 MR. STUPAK. But was that for all of your samples you drew was for 

a very specific purpose type of research? 

 DR. MOLCHAN. Well, for each protocol that we did at the time, we 

collected, as you have gathered, a lot of spinal fluid, and for each 

protocol we had, as I recall, a separate consent form. 

 MR. STUPAK. Okay. I guess that is the best way to get a consent 

form is--okay. 

 So it would have been unusual then to have it go outside of NIH in 

the protocol that you had established to get this donation, if you will? 

 DR. MOLCHAN. In a general sense or from my study? I mean-- 

 MR. STUPAK. The private gain companies in the mind of the donor, 

if you will. What is their expectation of how the sample is going to be 

used I guess is what I am trying to get at. 

 DR. MOLCHAN. Right. I would have to look at the exact wording on 

the consent form, but for the samples I drew, at least, they needed to be 

looked at in a paired way, on and off drug, to try to look at the effects of 

the drug. 

 MR. STUPAK. Sure, because you had a specific purpose that you 

were trying to test. 

 DR. MOLCHAN. Yes, and I recall that all protocol had a specific 

purpose. Again, the consent forms have been evolving and IRB policies, 

and from what I recall, we needed to get a specific consent form for each 

protocol that we did, because a number of the protocols did involve 

drawing spinal fluid. 

 MR. STUPAK. Sure, but if I am a donor, how many cc’s would you 

take? 

 DR. MOLCHAN. About 25. 

 MR. STUPAK. Okay, 25. And I give permission and I give 25 cc’s, 

and you used 5 cc’s, would that consent then restrict the remaining 20 

cc’s from going elsewhere, or was it only for your study? 

 DR. MOLCHAN. As long as it was sent with the understanding of 

what was in the consent form and set up through NIH-approved 

mechanisms, that I think would be reasonable. 

 MR. STUPAK. Okay. I guess we will have to take a look at one of 

those consent forms. 
175

 If you have more than what you are using, I guess another thing I am 

trying to arrive at, though, the remainder then is it restricted within NIH 

or can it be used outside of NIH? 

 DR. MOLCHAN. Oh, no. In these things, we keep them in these big 

freezers which are very carefully regulated and backed up and controlled. 

We keep some of what we collect, whether it is blood or spinal fluid, in 

hopes that an interesting assay--something interesting we will want to 

measure in the future will come along. So these things literally can be 

stored sometimes for decades. 

 MR. STUPAK. Okay. In fact, in your testimony that you talk about 

the cerebral spinal fluid samples, which are highly valued, can be stored 

in freezers for years, and that you and your NIH colleagues had every 

reason to believe that they would still be available. So it is your 

understanding that the samples which NIH investigators may have an 

interest in are generally preserved and made available for possible 

research along the lines in which they were drawn from, extracted from? 

 DR. MOLCHAN. That is a bigger area of policy than I am involved 

with, and again, I think some of those policies are being evolved and 

worked on. 

 MR. STUPAK. Okay. 

 You also state in your testimony that “As research for Alzheimer’s 

disease has progressed, the need for spinal fluid samples has increased as 

they may shed light on treatment options for this increasingly prevalent 

disease. All available scientific resources are indeed to fight AD.” 

Could you elaborate further for the committee and for our understanding 

on how the loss of these samples and data could hamper further research 

or publications in the field of this research? 

 DR. MOLCHAN. Okay. Are we talking about my specific study 

samples? 

 MR. STUPAK. Yes. 

 DR. MOLCHAN. Since another study was being planned by this 

Alzheimer’s clinical trial consortium that I work with now, it didn’t 

make sense that I had done a similar study and we couldn’t get 

information from it. 

 MR. STUPAK. The data, in other words? 

 DR. MOLCHAN. That we couldn’t get data. I was able to give some 

of my experience as far the safety of the drug that we were using and 

everything in these Alzheimer’s patients, and that was helpful, but it 

really would have been helpful to have more data on the effects on 

memory of what we were doing, as well as especially the spinal fluid 

because of being part of this new study that they want to do is to look at 

spinal fluid. It is a big part of helping us to try to understand what is 

going on in Alzheimer’s disease. We can look at various measures in 
176

spinal fluid, how those measures react to a drug, for example, tell us 

something about what is going on, what is going wrong in Alzheimer’s. 

 MR. STUPAK. If you know, you took samples from 25 subjects, 

right? 

 DR. MOLCHAN. Yes. 

 MR. STUPAK. Of those 25 subjects, is there still partial of that 25 

cc’s left for all 25 or are some of them gone, some of them have a little 

remaining? 

 DR. MOLCHAN. That is what I could never ascertain. From what I 

understand, Dr. Sunderland sent the last of the samples to a collaborator 

of ours to measure something that the people planning this next study 

were interested in, that we were all interested in. I never got a handle on 

what happened to most of it. 

 MR. STUPAK. Thank you. Thank you, Mr. Chairman. 

 MR. WHITFIELD. Yes, sir. Dr. Burgess, I think we have about 8 

minutes left in this vote. Would you like to start asking some questions, 

or would you prefer to just wait and come back after the next votes? 

 Why don’t you go ahead and start, then? 

 MR. BURGESS. Very well. Again, thank you for being here. 

 I kind of know what a lumbar puncture is, but for the benefit of the 

uninitiated, maybe you could just quickly go through the procedure for 

us. 

 DR. MOLCHAN. Okay. They really, for one thing, really don’t hurt 

that much, and they-- 

 MR. BURGESS. Well, the Chairman said they took three hours. 

Now, it may take the Chairman three hours, but it shouldn’t take the rest 

of us. 

 DR. MOLCHAN. He would definitely need more. We used to ask 

people--well-- 

 MR. WHITFIELD. We could break now. 

 DR. MOLCHAN. Well, let me just go through the procedure. It is a 

lumbar puncture or a spinal tap, and we withdraw some of the fluid that 

is in the sac that surrounds the brain and the spinal cord, and that has 

certain proteins in it that we are interested in. So to withdraw some of 

this fluid, we introduce a needle in between a couple of vertebra in the 

lumbar spine in the back. People are usually on their side when doing 

this, and the area is numbed up with some local anesthetic. We insert the 

larger needle and withdraw about 25 cc’s, which we allow to drip into 

however many--when I was doing it, about 10 tubes for use for various 

measurements. 

 MR. BURGESS. So it is a fairly invasive procedure? 
177

 DR. MOLCHAN. It is invasive. It is very safe and it contributes very 

much to our work, but yes, it is invasive. It is much more than drawing a 

blood sample. 

 MR. BURGESS. And in fact, 25 cc’s is a fairly generous sample for 

someone who is used to doing them diagnostically. 

 DR. MOLCHAN. Yes. 

 MR. BURGESS. We would have normally obtained five to 10 cc’s. 

 DR. MOLCHAN. That is right, when they did them, um-hum. 

 MR. BURGESS. And perhaps a little bit greater risk for things like 

headache and other sequella after-- 

 DR. MOLCHAN. That is not well-documented and we actually 

followed the incidents of headache, and especially in the older people, it 

is actually quite unusual, but that is the biggest side effect is headache. 

 MR. BURGESS. Now, Mr. Stupak was asking about whether the 

patients involved in these trials were informed about the lithium trial 

being concluded or ended and then these samples being used in newer 

trials. To the best of your knowledge, there was no--that information 

wasn’t given to the patients? 

 DR. MOLCHAN. No. 

 MR. BURGESS. Would that be unusual at NIH? 

 DR. MOLCHAN. Well, we had completed the data collection at least 

at that point. We had done all the spinal taps we were going to do and 

the next step would have been to work with some laboratories to measure 

what we were interested in. So as long as we were focusing on what was 

said in the consent form, measuring these paired samples on and off 

drug, then no, that would have been that. If it was going to be used for 

anything else, I am sure there were procedures that would have to be--

you would have to go through. 

 MR. BURGESS. Now, you had samples on 25 individuals in this 

particular study. Can you give the committee any idea of how many 

tissue samples, which would include, of course, blood, urine, spinal fluid, 

other tissues, how many tissue samples are stored just in the intramural 

portion of the National Institute of Health at any given time? 

 DR. MOLCHAN. On an overall? 

 MR. BURGESS. Yeah, on an overall. 

 DR. MOLCHAN. Yeah, I have no idea. 

 MR. BURGESS. I know I don’t either, but it has got to be a lot. 

 DR. MOLCHAN. Yeah, a lot is definitely what you are talking about 

of blood and urine specimens and cells. A lot. 

 MR. BURGESS. And yet, we have heard it mentioned several times 

that there should be a centralized databank, if you will, of all of the tissue 

stored at NIH. Do you think that is even technically feasible? 
178

 DR. MOLCHAN. Well, it depends how central. With our information 

technology now, and I know for some projects that we have in the 

university world that when we collect samples we do want to know what 

we are collecting and make them available to researchers to maximize 

their use. So these databases are starting to be built up. Again, it is a big 

coordinating effort using our information technology. 

 So they are underway and I don’t know where they are in the 

intramural program with that at this point. 

 MR. BURGESS. But in the year 2006, that is just kind of beginning? 

 DR. MOLCHAN. Yes. 

 MR. BURGESS. In 1996, that probably would have been unheard of. 

 DR. MOLCHAN. Yes, most likely. Yes. 

 MR. BURGESS. The fact that there wasn’t any centralized database 

for you to go to to find where your samples were, that wasn’t necessarily 

unusual? 

 DR. MOLCHAN. No. 

 MR. BURGESS. Someone else doing research on diabetes that had 

blood sugar samples might have the same trouble? 

 DR. MOLCHAN. Yeah, I would be surprised, but yeah, not that I 

know of. 

 MR. BURGESS. Whose responsibility was it to keep those samples 

safe and retrievable during your tenure there and then after you left, 

where did that responsibility get assigned? 

 DR. MOLCHAN. From what I understand and from what I thought, it 

resided with each laboratory chief who was in charge of the certain 

projects under which the samples were collected. 

 MR. BURGESS. And that laboratory chief in your section would have 

been? 

 DR. MOLCHAN. Dr. Sunderland. 

 MR. BURGESS. Can you just tell us a little bit about the lithium study 

without giving away any trade secrets? 

 DR. MOLCHAN. Yes. There is, actually, one drug company doing a 

similar study now, too, but-- 

 MR. BURGESS. I mean, lithium doesn’t cure Alzheimer’s. 

 DR. MOLCHAN. No, it does not. There has been some interesting 

data in the past few years showing that in cell studies and in mice studies 

that lithium seems to have some effects that hold off degeneration of 

neurons, including inhibiting the amyloid plaques and the neurofibrillary 

tangles. It is very interesting because lithium has never been thought of 

that way. So with these laboratory studies, it has become more of 

interest to use to see if we could give lithium and then see what happens, 

for example, in the spinal fluid to levels of amyloid and to levels 
179

indicating the fibrillary tangles to see if we should target drug 

development along those lines. 

 MR. BURGESS. And that is important, because even though you are 

not curing Alzheimer’s disease, even if you can slow down the course a 

little bit, that is important as well, isn’t it? 

 DR. MOLCHAN. As far as the study we were doing, we were trying 

to find out more. We know lithium and when we use drugs in this way 

that they work under certain mechanisms, inhibit certain enzymes and so 

then we test what we can measure in the spinal fluid and from that, we 

can ascertain whether that enzyme, for example, is inhibited or not and 

would we want to work to dis-inhibit it to help Alzheimer’s disease, 

things like that. So it is more mechanism. 

 MR. BURGESS. Do you know, do we know, does the committee 

know, is it available in our report or do you know the information about 

what were the samples used for, the samples that were diverted away 

from the NIH? Do we know what those were used for? 

 DR. MOLCHAN. I don’t know. 

 MR. BURGESS. So then to the best of our knowledge, there hasn’t 

been any published data about-- 

 DR. MOLCHAN. Well, there was not after I left the institute, the 

study wasn’t followed up, so no, there were no published data on the 

effects of lithium on these samples, which they were meant for. 

 MR. BURGESS. Were there any other studies of any type then done 

on these samples after they were diverted-- 

 DR. MOLCHAN. That is what I don’t know. 

 MR. BURGESS. --from your lab? 

 DR. MOLCHAN. I don’t know. 

 MR. BURGESS. So we don’t have that information? 

 DR. MOLCHAN. I don’t have it. I don’t know if anybody-- 

 MR. BURGESS. Does anybody have that information? 

 DR. MOLCHAN. The committee staff may have some of it. 

 MR. WHITFIELD. We have some of that information which I can talk 

to you about as we go over-- 

 MR. BURGESS. All right. 

 MR. WHITFIELD. Dr. Burgess, we have a minute to get over to vote, 

so when we come back we will recognize you for another 2 minutes. 

 MR. BURGESS. You are too kind, Mr. Chairman. I will delay further 

questions with that in mind. 

 [Recess] 

 MR. WHITFIELD. The hearing will resume, and at this time, I will 

recognize Dr. Burgess for his remaining two and a half minutes. 

 MR. BURGESS. Thank you, Mr. Chairman. 
180

 Dr. Molchan, did Dr. Sunderland ever talk to you about what 

happened to the samples or the research data from your study? 

 DR. MOLCHAN. Just in e-mails and phone calls. I got the 

information as related that the samples that he sent to our collaborating 

scientists was all that was left; that the rest was lost in freezer failures. 

He did indicate, I believe, that they had been used in--well, I would have 

to look at the records for sure, but from what I could get at the time, he 

gave me everything that was left. He mentioned some freezer thaw 

problems where samples were lost. As far as some data, he mentioned it 

is old data and everything--he seemed to be under the impression that it 

was published data, which it wasn’t. 

 So I got an incomplete response as to what happened. 

 MR. BURGESS. And just to reiterate for the committee, why were 

you unable to complete the lithium study? 

 DR. MOLCHAN. I had to leave the NIMH. My time was up there and 

I had to leave, and at the time wanted to stay in the area. I was 

committed to stay in the Bethesda area and wanted to stay in the public 

health service, so I transferred to the FDA. 

 MR. BURGESS. Was there no one in the lab that you sort of signed 

out to and said this is what I am working on, the taxpayers have invested 

this much money in this lithium study. Would you please continue it? 

 DR. MOLCHAN. No. 

 MR. BURGESS. Would that be common to do that within a research 

lab if someone had reason to leave the lab? 

 DR. MOLCHAN. Well, when we were there I was on staff at the NIH 

clinical center, so I was no longer a fellow or anything, but again, the lab 

chief--it would have been unusual. That just wasn’t part of the 

procedure. The lab chief had the responsibility for studies ultimately. 

 MR. BURGESS. Was the lithium study something that was assigned 

to you in the lab, or was this a concept that you had yourself that you-- 

 DR. MOLCHAN. It was something that I wanted to do as an 

independent project. I had the idea based on some actual laboratory 

research that I had done years ago. 

 MR. BURGESS. But other people in the lab you discussed the lithium 

study with, had you convinced anyone that this was worthwhile research, 

or did everyone else-- 

 DR. MOLCHAN. I thought so. I thought Dr. Sunderland, as well as at 

the time, the overall branch chief, and it went through, of course, the IRB 

committee of the NIMH, part of which debates whether it is a rational 

study to do, if it is worth doing, so yes. 

 MR. BURGESS. Does the committee need to be concerned that there 

are other studies that are just sort of dropped in mid-stride as people 

come in and come out of the NIH? 
181

 DR. MOLCHAN. Well, for clinical studies, I don’t think there is any 

good--I mean, there are a lot of studies started by post-doctorals, perhaps, 

that some may not be followed up. When someone leaves, I guess many 

times they go to a university--to another laboratory and bring data with 

them, so that happens. And as far as an overall plan for what happens, 

that is beyond my experience. 

 MR. BURGESS. Well, you said in your testimony since Congress has 

shown an interest in this matter, some progress has been made. Can you 

elaborate on what you mean by “some progress”? 

 DR. MOLCHAN. Well, the NIH has instituted some trans-NIH 

policies on trying to better keep track of these samples, for one thing, and 

I was also able to get some additional data that I needed, just some basic 

demographic data on the subjects that we had the spinal fluid on so I can 

include that in a publication. 

 MR. BURGESS. Very well. Mr. Chairman, you know, I would just 

point out that we do talk about having some sort of centralized databank 

and I think that is a wonderful thing, but you know, in 1996, 1997, I 

don’t know how feasible that was and in my experience in working in 

labs, I mean, you have got a refrigerator full of stuff and not everyone 

knows what all is contained therein and the importance thereof. I don’t 

mean that that is right, if it sounds like the NIH is well on the way to 

remedying and rectifying that problem, but I just wonder about our 

ability to draw conclusions on a practice from 10 years ago when quite 

frankly, the computer database technology just may not have existed to 

keep track of what realistically may have been several million tissue 

specimens contained at the NIH. 

 I yield back. 

 MR. WHITFIELD. Thank you, Dr. Burgess, and of course, that is 

what we are going to be focused on as we move forward, and tomorrow 

we will have some other witnesses, including the Director of the National 

Institute of Mental Health. 

 At this time, I recognize Mrs. Blackburn for 10 minutes. 

 MRS. BLACKBURN. Thank you, Mr. Chairman. Dr. Molchan, thank 

you, and thank you for your patience with allowing us to go over and 

vote and then come back. 

 I will tell you that I am not a physician like Dr. Burgess, and not 

been involved in any of the research projects like he has, but I am very 

typical of a lot of Americans in that I have lost a loved one to 

Alzheimer’s. And through that, have watched some of the research and 

some of the progress and some of the--I guess you would call them nearmisses in your community. And I have found this really quite interesting 

to read through the materials for this hearing, and I appreciate very much 

your stepping forward, and working with us. You are making the 
182

information aware, but I don’t have to tell you, whether it is the NIH or 

any number of other Federal agencies, there is an arrogance that exists 

within the bureaucracy, a lack of respect that does exist for, I think, this 

body and for our oversight and for our desire to be certain that the 

taxpayers’ money is appropriately spent. And I think it was quite 

appropriate that the Chairman of this committee, Mr. Barton, mentioned 

trust when he made his opening remarks, because it is a loss of trust in 

the NIH and how they spend their funds, and as we have the head in 

here, it is something that we are going to be discussing and visiting with 

him about. 

 A couple of questions I want to go back to, and I feel like I have got 

a page of notes here as you have talked and given your comments today. 

You mentioned that the comment was made you were told that you 

didn’t find out exactly what had happened, that the loss of the samples 

was attributed to freezer loss and that nothing seemed to make sense. 

Now, who was it that told you that? Was it Dr. Sunderland or someone 

that worked with him? 

 DR. MOLCHAN. Dr. Sunderland, yes, in e-mails, yes. 

 MRS. BLACKBURN. Okay. So he himself-- 

 DR. MOLCHAN. Yes. 

 MRS. BLACKBURN. --told you that, and you know that didn’t seem 

right, because you know you are not going to lose that much through 

freezer burn, if you will-- 

 DR. MOLCHAN. Correct. 

 MRS. BLACKBURN. --or-- 

 DR. MOLCHAN. Or whatever reason. I just know how carefully we 

kept track of them when I was there. 

 MRS. BLACKBURN. Okay. 

 DR. MOLCHAN. And if there was a freezer failure, there would have 

been some documentation of that, dates and which samples were lost, 

and there is just nothing specific. 

 MRS. BLACKBURN. And I would imagine that the NIH with these 

freezers runs them from an operational standpoint that you have a 

generator backup so that you are never down, and you have got a flush 

point to move over in case you were to lose power, you would 

immediately go to a generator? 

 DR. MOLCHAN. I haven’t dealt with these freezers for a long time, 

but they are quite technical and backed up and-- 

 MRS. BLACKBURN. As I would imagine and we would expect. 

 DR. MOLCHAN. A record of the temperature every 24 hours and-- 

 MRS. BLACKBURN. Okay. When I had stepped out of the room, I 

think that you were mentioning to our Chairman the material transfer 
183

process. Were you giving a description of what that material transfer 

process was? 

 DR. MOLCHAN. I was probably explaining that I really--from my job 

back then at NIMH and my job now--I really haven’t dealt with those, so 

I would have to--there is a whole staff at NIH now to help people deal 

with those, because it is getting more complex. 

 MRS. BLACKBURN. Okay. Now, Mr. Chairman, do we have 

something in writing that describes for us the process by which samples 

would be transferred within NIH and then to actually leave the 

jurisdiction of NIH? Do we have that in writing? Is there a document 

that we have received or should we request that from our witness? 

 MR. WHITFIELD. Just a minute. I will ask our counsel here. 

 MRS. BLACKBURN. And at the same time, do they have in writing a 

review process by which they would go back and review why a sample 

was requested? 

 MR. WHITFIELD. We have material transfer agreements. We have 

copies of that, and it is in the binder. It is Exhibit #2. Then we have 

Exhibit #38 is NIH technology transfer in U, an explanation of that, and 

then of course, tomorrow, as you know, we are going to have a number 

of panels here, three panels and everyone will be from NIH or has been. 

We will be able to get to that in more detail then. 

 MRS. BLACKBURN. Okay. 

 Dr. Molchan, I think you are familiar with those transfer processes, 

and would you agree that those and that the review, is it substantial, does 

it give you enough coverage, is there enough review if samples are 

requested? 

 DR. MOLCHAN. The samples of materials transfers? 

 MRS. BLACKBURN. Yes. 

 DR. MOLCHAN. I really have not dealt with them in any detail so I 

can’t-- 

 MRS. BLACKBURN. Okay. 

 Let me move on then. Dr. Sunderland in his relationship with Pfizer, 

would that be--from your vantage point, would you see that as being a 

normal or abnormal relationship for a researcher from NIH? 

 DR. MOLCHAN. Again, I don’t have the details of the relationship, 

and haven’t been in contact with Dr. Sunderland in years. I can’t 

comment since I don’t know. 

 MRS. BLACKBURN. Just from other researchers. And then also, is it 

a normal practice for NIH researchers who are working on a project to go 

and speak and be paid for the speeches for different pharmaceutical 

companies and then to be invited into relationships with those 

companies? 
184

 DR. MOLCHAN. As far as I know, it is not, and again, it never 

entered my area of activity or interest, especially since I was at the Food 

and Drug Administration, so I was totally out and divested in everything. 

 MRS. BLACKBURN. Okay. And then do you know if there is an 

oversight process and who would be involved in that process that would 

be checking the relationships with the NIH researchers? 

 DR. MOLCHAN. I don’t know. 

 MRS. BLACKBURN. And you never had anyone come to you and 

question a relationship that you had? 

 DR. MOLCHAN. I haven’t been involved in any relationships, you 

know, since I have been in the Government, especially since I went 

through the FDA. 

 MRS. BLACKBURN. Okay. 

 DR. MOLCHAN. It is just definitely not allowed there. 

 MRS. BLACKBURN. So while you were aware of others that were 

paid consulting fees-- 

 DR. MOLCHAN. Yes. 

 MRS. BLACKBURN. --had consulting agreements, you had none of 

your own? 

 DR. MOLCHAN. No. 

 MRS. BLACKBURN. Okay. All right. 

 Let me ask you this, because I thought your comments to Dr. 

Burgess were interesting when you were talking about the lithium study 

and it just dissipated. How much money did you spend on that study 

through your process? 

 DR. MOLCHAN. Well, I didn’t have a budget myself, and what it cost 

from the budget of the laboratory I was in, Dr. Sunderland’s group and at 

that point, our branch chief, Dr. Murphy, they would have the numbers 

on that. I don’t know what the cost was back then. I just don’t, since I 

didn’t have my own budget. 

 MRS. BLACKBURN. Okay. 

 Well, thank you, and Mr. Chairman, I will yield back. 

 MR. WHITFIELD. Thank you, Ms. Blackburn. 

 Mr. Molchan, Mr. Stupak in either his opening statement or 

questions, mentioned that around $6 million was the estimated cost of 

collecting these samples. Do you know how that figure was determined 

or calculated? 

 DR. MOLCHAN. He was talking, I think, of more samples than just 

involved in my study-- 

 MR. WHITFIELD. Right. 

 DR. MOLCHAN. --so I don’t know. 

 MR. WHITFIELD. Okay. 
185

 And now, what makes spinal fluid so valuable? Just the process of 

what you have to go through to get it? 

 DR. MOLCHAN. It is not the easiest thing to collect because you have 

to have special equipment, you have to have special storage for it. A lot 

of people, especially in this country--it is a common medical procedure 

done in many hospitals for many different reasons, and it is very safe, but 

still I guess the vision of having a needle placed into your back doesn’t 

bode well for most people, so we have to convince people that it is worth 

it. The spinal fluid itself bathes the brain, some of the chemicals in the 

brain. It is the closest thing you can get to the brain without taking a 

piece of the brain. 

 MR. WHITFIELD. Absolutely. 

 I also want to ask unanimous consent that we enter into the record a 

form that is the consent to participate in a clinical research study, and this 

actually is a form that has you listed as one of the principal investigators. 

I don’t think we have a copy of this for our record, so I would ask 

unanimous consent that we enter that into the record. 

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 MR. WHITFIELD. At this time, Chairman Barton, would you like to 

ask some questions of this witness? 

 CHAIRMAN BARTON. Am I the last to question here? 

 MR. WHITFIELD. Yes, sir. 

 CHAIRMAN BARTON. Okay. 

 I have some questions. They are going to be a little bit more generic. 

 Does the administration at NIH share the committee’s concern about 

lack of a centralized tracking system for human tissue sample collection 

and maintenance? 
196

 DR. MOLCHAN. You would have to--again, I am not at that level of 

policy and administration, so I don’t--from what I have seen in e-mails, 

there is more and more interest in it in general in the research 

community. 

 CHAIRMAN BARTON. Well-- 

 DR. MOLCHAN. The details of NIH, since that is not my purview-- 

 CHAIRMAN BARTON. Well, let me rephrase the question. 

 DR. MOLCHAN. Yes. 

 CHAIRMAN BARTON. Do you share the concern? 

 DR. MOLCHAN. Based on my recent experience, understanding that 

these samples were collected several years ago, I think things are getting 

better, and I have seen movements towards policies and working groups 

being put in place to start to get some more consistent policies. 

 CHAIRMAN BARTON. All right. 

 What knowledge do you have of these spinal fluid samples: Have 

you been told what happened to the spinal fluid samples that you were so 

interested in that you couldn’t get access to? 

 DR. MOLCHAN. I guess just from two sources. From Dr. 

Sunderland, which I just mentioned, that there weren’t anymore left. 

Some of them were lost in freezer thaws, and then from what I 

understand, the committee found that some of them had gone to Pfizer 

from the NIMH. 

 CHAIRMAN BARTON. Well, 95 percent that according to committee 

staff briefings were unused, how many of those, in your opinion, have 

been misused or inappropriately sent outside of NIH? 

 DR. MOLCHAN. That is what I can’t have any documentation of or 

try to ascertain but never got an answer, other than general answers that 

they are not there anymore, they were lost. 

 CHAIRMAN BARTON. You are okay with that? 

 DR. MOLCHAN. Well, I wasn’t okay with that. That is how we 

ended up here. 

 CHAIRMAN BARTON. Do you have a solution? 

 DR. MOLCHAN. From my purview, I went through channels for a 

number of months and then expressed my concerns to the committee, and 

had done everything I felt I could do. I didn’t think I was going to get an 

answer myself, and thought perhaps the committee might. 

 CHAIRMAN BARTON. You have hardly answered--I gave you a 

question right off the bat where you could say yes, we need a centralized 

system for monitoring and tracking our human tissue samples, and you 

basically told me that was outside your area of expertise; that you really 

didn’t have a position on it. 
197

 DR. MOLCHAN. Well, it depends on a lot of details on that. I know 

that when we get into these policy things and at what level, it is a 

complex question and I think-- 

 CHAIRMAN BARTON. It is not that complex. 

 DR. MOLCHAN. I mean, in a general sense-- 

 CHAIRMAN BARTON. If you don’t have a system in place-- 

 DR. MOLCHAN. Right. 

 CHAIRMAN BARTON. --to back it across an agency, you are 

depending on pure faith that everybody-- 

 DR. MOLCHAN. Of course, there are some systems in place. Again, 

how--and it is getting more consistent across the various institutes. I just 

don’t know details of that since I am not-- 

 CHAIRMAN BARTON. If you were in charge of the NIH, what would 

you change about the current system for human tissue sample collection, 

storage, and inventory, if you were in charge? 

 DR. MOLCHAN. Well, again, the NIH is a big place and I am just one 

tiny piece of it, and these samples came from 10 years ago. So yes, there 

needs to be careful documentation of who these samples were taken from 

and when and for what and the consents, where they go, what data results 

from them. Hopefully it will be shared among investigators, and I hope a 

lot of that is underway. I just can’t, under oath, I guess I am just not 

comfortable going into too much detail because it is beyond my 

experience. 

 CHAIRMAN BARTON. So you have no recommendation? 

 DR. MOLCHAN. Well-- 

 CHAIRMAN BARTON. What did you expect the committee to do 

when you contacted us? 

 DR. MOLCHAN. Well, I know that there has been some progress 

made, that there are trans-NIH-- 

 CHAIRMAN BARTON. Is somebody at NIH pressuring you to hold 

back? 

 DR. MOLCHAN. No. 

 CHAIRMAN BARTON. Are you under any kind of threats? I have 

given you every opportunity to just absolutely tell us what you think 

needs to be changed, and you have resolutely refused. That is fine. You 

don’t have to, but my gosh-- 

 DR. MOLCHAN. I just don’t know-- 

 CHAIRMAN BARTON. --you are the person who came to us and said 

we have got a problem. You would think you would have some ideas 

about how to solve it, other than just say-- 

 DR. MOLCHAN. Yes. 

 CHAIRMAN BARTON. --it is outside of my area of expertise. 
198

 DR. MOLCHAN. NIH is a big place and there are lots of different labs 

and different institutes, and I just have no idea of the policies in those 

places. It is outside of my purview, but yes, of course we need systems 

to track these things. 

 CHAIRMAN BARTON. How about some penalties if you abuse the 

tracking system? 

 DR. MOLCHAN. I would hope-- 

 CHAIRMAN BARTON. Do you think it is appropriate that some of 

your spinal fluid samples went to Pfizer? 

 DR. MOLCHAN. Not unless they were used as indicated in the 

consent form and from what I have gathered, they were not, so no. 

 CHAIRMAN BARTON. Do you think Dr. Sunderland was truthful and 

honest with you when you inquired about those samples? 

 DR. MOLCHAN. Well, since I never got a complete answer and we 

all like to see data evidence, no, that is why I went further up the chain. 

 CHAIRMAN BARTON. All right. Do you believe at least said that he 

was not truthful and open with you? 

 DR. MOLCHAN. Yes. 

 CHAIRMAN BARTON. What would he have had to have done to have 

met your requirement that he didn’t do? 

 DR. MOLCHAN. Just document, just tell us what happened to the rest 

of them, whether it was really in freezer failures--that large volume--

again, from the careful documentation I knew went on in that laboratory 

on these types of things, I would have liked to see some documentation 

of what happened and when and there was just nothing like that. 

 CHAIRMAN BARTON. But to your knowledge today, there is not an 

acceptable accounting of those samples that were unused, is there? 

 DR. MOLCHAN. Correct. 

 CHAIRMAN BARTON. Are you okay with that? 

 DR. MOLCHAN. No, I have never been okay with it, and I have done 

what I can do-- 

 CHAIRMAN BARTON. If you were Mr. Whitfield or Mr. Stupak, the 

Chairman and Ranking Member, would you insist on an accurate 

accounting of those samples? 

 DR. MOLCHAN. Yes. 

 CHAIRMAN BARTON. Okay. 

 DR. MOLCHAN. Yes. 

 CHAIRMAN BARTON. I guess, Mr. Chairman, that is all the questions 

I have. 

 MR. WHITFIELD. Thank you, Mr. Chairman. 

 Mr. Stupak, I understand you have a few additional questions? 

 MR. STUPAK. Yes. Doctor, if I may, to your right there is your 

consent form. You see it right there? 
199

 DR. MOLCHAN. Yes. 

 MR. STUPAK. And I note first that the form appears to be dated 

October of ‘84, so that form is already 22 years old. Have they updated 

the form since then, do you know? 

 DR. MOLCHAN. These are all 1984. 

 MR. STUPAK. Let me further identify, this is your evaluation of 

lithium treatment in dementia and Alzheimer’s patients. 

 DR. MOLCHAN. That is right. 

 MR. STUPAK. This is your-- 

 DR. MOLCHAN. And these are the details of the consent form that I 

asked them to sign, that is right. 

 MR. STUPAK. So you don’t know if they have updated this consent 

form since then? 

 DR. MOLCHAN. The template I guess came from 1984, and I don’t 

know. 

 MR. STUPAK. Okay. Let me ask you this, because I asked a lot of 

questions about consent form and things like that. 

 The consent forms only apply to your specific lithium study, so it 

raises at least two questions with me. Could the samples then be used for 

the consortium study on lithium use in Alzheimer’s patients--or research, 

I should say, and the consortium, I mean with the University of 

Pittsburgh. Do you believe that based on this informed consent, those 

samples could be used with the consortium at the University of 

Pittsburgh? 

 DR. MOLCHAN. Since we were using samples on and off the drug of 

interest to see what the effects were, yes. 

 MR. STUPAK. Okay. Then how could such a specific consent form--

because I do agree that it is pretty specific--cover transfer to Pfizer for a 

non-lithium study? 

 DR. MOLCHAN. It does not, from what I can see. 

 MR. STUPAK. And then there is no way you could bend that to make 

it cover-- 

 DR. MOLCHAN. No. 

 MR. STUPAK. --Pfizer, unless they are doing something with lithium, 

right? That is your understanding? 

 DR. MOLCHAN. Yes. 

 MR. STUPAK. Okay. 

 DR. MOLCHAN. That is right. To look at the effects of the drug, yes. 

 MR. STUPAK. Correct, because you deal with a number of the neurotransmitters there, because--right? And you are looking to see how 

lithium acts on it? 

 DR. MOLCHAN. That is right, yes. 

 MR. STUPAK. Help me out here, acetocholene? 
200

 DR. MOLCHAN. Acetocholene. 

 MR. STUPAK. Acetocholene is a brain chemical that serves as a 

messenger or neuro-transmitter in the brain and lithium does affect that, 

correct? 

 DR. MOLCHAN. What we have been able to see in more Alzheimer’s 

specific measures having to do with the amyloid that is deposited in the 

brain, things like that. 

 MR. STUPAK. Right, but that is spelled out pretty well in this study? 

 DR. MOLCHAN. But still we are looking at the effects of lithium on it 

to see if we should, again, go in the direction of a drug mechanism in the 

way that lithium works, if we should try to develop something similar 

with not so many side effects, for example. 

 MR. STUPAK. Thank you. I have nothing further, Mr. Chairman. 

 CHAIRMAN BARTON. Mr.-- 

 MR. WHITFIELD. Yes, Mr. Chairman? 

 CHAIRMAN BARTON. I have just one or two more questions. 

 Dr. Sunderland, who has been subpoenaed to testify before this same 

subcommittee tomorrow, I believe, we were led to believe is going to 

plead the Fifth Amendment against self-incrimination, but he may not, 

but we are led to believe that. In your view, do you think that is an 

appropriate thing for him to do, in terms of the jurisdictional issues at 

NIH and responsibilities to be open and transparent in dealings with the 

public? 

 DR. MOLCHAN. I think NIH scientists should be as open and 

transparent with the public as possible, and from my experience, 

generally they are, so yes, they should be. And as far as him taking the 

Fifth, I don’t know his full situation. I am not a lawyer, so I can’t 

comment on that. 

 CHAIRMAN BARTON. Did he ever indicate to you when you were 

trying to get answers on these same questions that you should just mind 

your own business or bug off or it wasn’t your responsibility anymore? 

 DR. MOLCHAN. Not from him. I got that impression from the 

NIMH director. 

 CHAIRMAN BARTON. And who is that person? 

 DR. MOLCHAN. Dr. Insel. That was from an e-mail where he 

indicated that I should, you know--Dr. Sunderland is occupied with 

plenty of other things right now. Please leave him alone. 

 CHAIRMAN BARTON. I understand how busy that fellow can be. 

 DR. MOLCHAN. Yeah. 

 CHAIRMAN BARTON. What is the general loss associated with 

freezer melting or whatever the technical term is? Would that normally 

be like one or two percent or 40 or 50 percent? 
201

 DR. MOLCHAN. It depends on the sample. I mean, in some of these 

freezers we have whole brains, for example, and it depends on what you 

are measuring and it depends on the sample. 

 CHAIRMAN BARTON. Well, in general, wouldn’t you expect that 

high value human tissue samples, especially like spinal fluid that are 

difficult to obtain, that there would be some fairly elaborate-- 

 DR. MOLCHAN. There are. 

 CHAIRMAN BARTON. --mechanisms and fail-safe-- 

 DR. MOLCHAN. At the time I left the NIMH, there were quite 

elaborate systems of backup-- 

 CHAIRMAN BARTON. You shouldn’t have a high percentage of loss-- 

 DR. MOLCHAN. Correct. 

 CHAIRMAN BARTON. --just from something like that? 

 DR. MOLCHAN. Right. There was backup and alarms, people would 

be called if there was a failure. 

 CHAIRMAN BARTON. Okay. 

 DR. MOLCHAN. Or if any temperature aberration, you know. 

 CHAIRMAN BARTON. Staff wants me to ask this question. What is 

the average cost per human subject in an Alzheimer’s disease clinical 

trial? Average cost per human subject in an Alzheimer’s disease clinical 

trial. 

 DR. MOLCHAN. For the Alzheimer’s consortium that we deal with at 

the National Institute on Aging, we have been able to calculate that, and 

we have records. What did we say, about $12,000 per subject. Now, it 

depends on the length of the trial and how many tests you do, things like 

that, but on average for the trials we have done at NIA, it has been 

$12,000 per subject for what they call direct costs, and it is much more 

than that when you look at total costs when you are including the 

research infrastructure and data storage and analysis and other things 

involved most specifically with research. 

 CHAIRMAN BARTON. What percentage of that is the collection of 

spinal fluid, do you know? 

 DR. MOLCHAN. No. 

 CHAIRMAN BARTON. Just generally, would it be big percentages, 

little percentage? 

 DR. MOLCHAN. Well, when we collect spinal fluid--we haven’t done 

it very routinely in studies in the past several years. We used to, and 

then we fell away from it, and now with the importance of it, we are 

including it in many more studies now. I just know, for example, for the 

lithium study that is being proposed for this consortium, the cost is 

estimated to be $17,000 per patient. 

 CHAIRMAN BARTON. Well, if Dr. Sunderland used some of these 

spinal fluid samples that we don’t know what happened to, we know that 
202

528 subjects were used in his Pfizer project, so based on your knowledge 

of the spinal fluid sample volume, how much of that missing spinal fluid 

would be needed for 528 subjects in this Pfizer project study? 

 DR. MOLCHAN. It would--again, how much spinal fluid would he 

need for--depend on, again, what he was measuring and lots of variables. 

 CHAIRMAN BARTON. But I mean, again, I am not asking you to be 

accurate to the milliliter. 

 DR. MOLCHAN. Yeah. 

 CHAIRMAN BARTON. But would it have taken half of the spinal fluid 

or-- 

 DR. MOLCHAN. Oh, from a spinal tap? 

 CHAIRMAN BARTON. Yeah. 

 DR. MOLCHAN. Most of these assays take just a tiny amount, 2, 3 

cc’s, usually much less. Two or 3 cc’s, say, out of the 25. Whether there 

are some tests out there that need more, I am not sure, but usually it is 

just a fraction of what we collect during a spinal tap, yes. 

 CHAIRMAN BARTON. I mean, but if he--and I am not saying that he 

did, okay, this is purely hypothetical. If he totally used these spinal fluid 

samples that are unaccounted for for this 538 subject project at Pfizer, 

would that have consumed one-third, one-fourth, one-fifth-- 

 DR. MOLCHAN. I don’t know, since I don’t know all of his projects 

that he was doing with Pfizer. 

 CHAIRMAN BARTON. But it would take at least 3 cc’s per subject? 

 DR. MOLCHAN. I would think, yes. 

 CHAIRMAN BARTON. When you take a spinal tap from an individual, 

how much fluid do you get out of that? 

 DR. MOLCHAN. Generally around 25 cc’s. 

 CHAIRMAN BARTON. So it would take at least one-eighth. 

 DR. MOLCHAN. It is possible, yes. 

 CHAIRMAN BARTON. Just mathematically we would say-- 

 DR. MOLCHAN. Yes. 

 CHAIRMAN BARTON. --he used an eighth of--that would be a fair-- 

 DR. MOLCHAN. That is a fair estimate. 

 CHAIRMAN BARTON. --guess? 

 DR. MOLCHAN. Yeah, you don’t like to put all your spinal fluid in 

one place, I hope, or send it to one collaborator, and you often want to 

keep specimens like that that are non-renewable on reserve for future 

interesting possibilities. 

 CHAIRMAN BARTON. Okay. 

 MR. STUPAK. Mr. Chairman, if I may? 

 CHAIRMAN BARTON. Sure. 

 MR. STUPAK. In the type of research that Pfizer was doing, I 

understand it is proteomics? 
203

 DR. MOLCHAN. Proteomics, yes, looking at-- 

 MR. STUPAK. Does that take more fluid than a normal-- 

 DR. MOLCHAN. That is what I--since I am not a laboratory assay 

person, I think some of those take a little more, maybe a few cc’s, but I 

don’t know really details of which proteins they are measuring, so I don’t 

know. 

 MR. STUPAK. But it is fair to say in this type of study or research 

you are conducting, they would have needed more than normal of the 

fluid? 

 DR. MOLCHAN. More than normal as opposed to-- 

 MR. STUPAK. In the other testing, compared to the lithium test. 

 DR. MOLCHAN. I think they do need--from what I understand, you 

need a fairly large volume compared to measuring some other things that 

were routinely measured. 

 CHAIRMAN BARTON. Pilfered. 

 MR. STUPAK. Thank you. Yield back to the Chairman. 

 CHAIRMAN BARTON. My final question. I asked you earlier what 

the cost per subject, and you said between $12,000 and $17,000. We 

really didn’t get a good estimate if you know what the spinal fluid cost of 

that was, but let us assume that it is one-eighth. That would be about 

$1,500 per subject times 528 subjects, that is close to three-quarters of a 

million dollars that was used inappropriately. 

 DR. MOLCHAN. Well, the 538 came from a number of different 

protocols, the 538, and I don’t know what was in all those consent forms, 

for one thing. 

 CHAIRMAN BARTON. If three-quarters of a million dollars of tissue 

samples were used in a privately funded study, somebody should sign off 

on that and the Government should be reimbursed for that cost. Do you 

agree with that? 

 DR. MOLCHAN. Yes, certainly. 

 CHAIRMAN BARTON. Okay. I yield back, Mr. Chairman. 

 MR. WHITFIELD. Thank you, Mr. Chairman. 

 That concludes this section of this hearing, and Dr. Molchan, we 

appreciate your being with us today. 

 Tomorrow, we will have some witnesses that hopefully will be able 

to be more specific on suggested protocols as we seek ways to guarantee 

the tracking of these human tissue samples. Tom Insel, who is the 

director of National Institute of Mental Health, is one of the witnesses. 

The Deputy Director for Intramural Research, Michael Gottsman, will be 

here, in addition to Dr. Trey Sunderland, Dr. Karen Putnam, and Dr. 

David Friedman. 

 So we will recess this hearing until tomorrow at 10:00 a.m., and Dr. 

Molchan, thank you again for being with us. 
204

 [Whereupon, at 4:52 p.m., the Subcommittee was recessed, to 

reconvene the next day at 10:00 a.m.] 
205

HUMAN TISSUE SAMPLES: NIH 

RESEARCH POLICIES AND PRACTICES 

WEDNESDAY, JUNE 14, 2006 

HOUSE OF REPRESENTATIVES, 

COMMITTEE ON ENERGY AND COMMERCE, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

Washington, DC. 

The committee met, pursuant to notice, at 10:02 a.m., in Room 2322 

of the Rayburn House Office Building, Hon. Ed Whitfield (Chairman) 

presiding. 

 Members present: Representatives Stearns, Bass, Ferguson, Burgess, 

Blackburn, Barton (ex officio), Stupak, DeGette, Inslee, and Whitfield. 

 Staff present: Mark Paoletta, Chief Counsel for Oversight and 

Investigations; Alan Slobodin, Deputy Chief Counsel for Oversight and 

Investigations; Mike Abraham, Legislative Clerk, Ryan Ambrose, 

Legislative Clerk; John Ford, Minority Counsel; Jessica McNiece, 

Minority Research Assistant; and William Garner, Minority Professional 

Staff Member. 

 MR. WHITFIELD. I would like to call this hearing to order. 

 Yesterday we had one panel of witnesses which was one witness, Dr. 

Susan Molchan, and today we are continuing this hearing on human 

tissue samples, NIH research policies and practices, and today we will 

have three panels of witnesses. 

 First of all, I want to thank all of you for joining us this morning. 

We made our opening statements yesterday so you are going to be very 

lucky. You don’t have to hear a lot of opening statements today. And I 

would just make the comment that obviously all of us admire and respect 

the great work that is done at NIH. It is a premier research institution 

that is doing a tremendous job in trying to find cures and preventions for 

all sorts of diseases and it is a premier institution. I want to assure 

everyone today as the Chairman of this subcommittee, speaking for 

myself, I am not out to get anyone. But we do think it is essential that 

this institution with its reputation take all steps necessary to ensure the 

integrity of its research, particularly when people are donating samples. 

And we want to remove all possibilities of conflicts of interest or the 

appearance of conflict of interest. And so that is why we are particularly 

excited that you are here today and we look forward to the testimony 

from all of you. 
206

 On the first panel we have Dr. Thomas Insel, who is the Director of 

the National Institute of Mental Health at the National Institutes of 

Health, and we have Dr. David Friedman, who lives in Connecticut, so 

you will be the first two witnesses, and then in addition to Dr. Insel and 

Dr. Friedman, I guess accompanying you, Dr. Insel, we have Dr. Donald 

Rosenstein, who is the Acting Clinical Director at the National Institute 

of Mental Health. We have Mr. William Fitzsimmons, who is Executive 

Officer of the National Institute of Mental Health, and then we have Ms. 

Suzanne Winfield, who is the Technology Transfer Officer at the 

National Institute of Mental Health, but it is my understanding that Dr. 

Insel, you will be testifying and these three people will be here to assist if 

it is necessary. Is that correct? 

 DR. INSEL. That is correct. 

 MR. WHITFIELD. And Dr. Friedman, you will be testifying. As you 

know, this is an Oversight and Investigations Subcommittee hearing and 

it is our policy to take testimony under oath, and Dr. Insel, do you or Dr. 

Friedman have any difficulty testifying under oath today? 

 DR. INSEL. I do not. 

 MR. WHITFIELD. And under the rules of the House and the rules of 

the committee, you are entitled to legal counsel to advise you, and I 

would ask, do either of you have legal counsel with you today? 

 DR. INSEL. I do not. 

 MR. WHITFIELD. In just a minute I am going to swear you in, but 

before I do, I want to ask Mr. Stupak, the Ranking Member, if he would 

like to make any comments before we get started. 

 MR. STUPAK. No, Mr. Chairman. 

 [Witnesses sworn] 

 MR. WHITFIELD. You are now under oath, and Dr. Insel, we will call 

upon you for your 5 minute opening statement. 

STATEMENTS OF THOMAS R. INSEL, M.D., DIRECTOR, 

NATIONAL INSTITUTE OF MENTAL HEALTH, 

NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT 

OF HEALTH AND HUMAN SERVICES; AND DAVID L. 

FRIEDMAN, PH.D. 

 DR. INSEL. Thank you very much, Mr. Chairman. 

 I have handed out some testimony which probably would go much 

more than 5 minutes. In thinking about this, I know you have many 

questions to ask. We have a lot that we would like to discuss with you, 

and I think rather than going through those five or six pages, if I can just 

provide you a very simple statement which I hope will be seen as in 

essence a statement of the principles that we are here for because I think 
207

one of the things that we need to keep our eyes on here is what we are 

about and why it is so important that we protect the NIH mission. 

 As you mentioned, I am the Director of the National Institute of 

Mental Health, and this is an agency that has a large extramural 

component. Ninety percent of what we do is at universities and clinics 

and hospitals all around the country. We are here to focus on the 

intramural part, which is ten percent of our effort and it is the part that 

resides here in Bethesda, Maryland, and the part that we often think of as 

the jewel in the crown because it is a place for highly innovative, 

exciting science. 

 But I am also here as a physician and a scientist and I think you need 

to understand that I am absolutely committed to the mission of the NIH, 

which is to make discoveries to improve human health. For us, the 

clinical research which is part of what we do has to be understood as a 

real partnership and it can only be done because it is a partnership 

between clinical researchers who work as scientists and physicians and 

volunteers, research volunteers. These are people who may have 

illnesses, they may be actually healthy subjects, but they undergo painful 

and sometimes risky procedures to participate in this important mission 

that we have at the NIH. 

 We can only do this kind of work, it is just clear to all of us, if we 

understand that we are committed and the public understands that we are 

committed to minimizing risk, to protecting privacy and to using this 

information for the common good. That just has to be a fundamental, 

and as we think about this, I think you will agree that this whole 

enterprise that we are involved with really rests on trust. We can’t do 

this without the public trust. We can’t do this without your trust and we 

can’t do this without trusting each other to some extent, trusting each 

other that we will do the right thing. 

 Whenever there is a conflict of interest or even a perceived conflict 

of interest, this trust is placed in peril and that is the situation that we are 

in this morning and as we talk about this individual case. There are 

many policies and there are various levels of review to preclude conflicts 

of interest and we will go through those I think over the course of the 

next few minutes, but basically it comes down to one simple principle, 

and this has to be seen for us as true north. That simple principle is that 

volunteers, their families, and the public must know that an NIH scientist 

is working for them and not for anyone else. We cannot allow a scientist 

or anyone else at NIH to trade his or her public role for private gain. It is 

very simple. That is the basis from which our ethics policy is built. Dr. 

Zerhouni sent out another message late last night to remind all NIH 

employees that that is a fundamental and that has to be understood. 

Violating this simple principle jeopardizes public trust and everything we 
208

stand for at NIH and I will do everything, everything I can to ensure that 

this does not happen. 

 I look forward to your questions. 

 [The prepared statement of Thomas R. Insel, M.D. follows:] 

PREPARED STATEMENT OF THOMAS R. INSEL, M.D., DIRECTOR, NATIONAL INSTITUTE OF 

MENTAL HEALTH, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Mr. Chairman and distinguished members of the Subcommittee: I am Dr. Thomas 

Insel, the Director of the National Institute of Mental Health (NIMH), the component of 

the National Institutes of Health (NIH), an agency of the Department of Health and 

Human Services (HHS), tasked with responsibility for developing improved methods of 

diagnosing, treating, and preventing mental disorders, including schizophrenia, autism, 

and mood and anxiety disorders. 

To accomplish this mission, the President and the Congress have provided the 

NIMH a staff of over 700 employees and a budget of approximately $1.4 billion for 

Fiscal Year 2006. Nearly 90% of this budget, or almost $1.2 billion, is allocated to the 

support of biomedical research and research training activities through various grant, 

contract, and fellowship mechanisms at universities, hospitals, and clinics around the 

nation. The remaining $160 million per year is used to support a unique and critical 

intramural biomedical research program on the NIH campus in Bethesda, Maryland. This 

program was established to provide rapid responses to public health emergencies and to 

support an environment of innovation and creativity for biomedical discoveries. It is the 

operation of this intramural research program that is the focus of this hearing today. 

 First, I want to commend the Committee for its interest in NIH and the NIMH. As a 

public servant, I am well aware of my responsibilities to be a careful and vigilant steward 

of the public resources entrusted to my care. I know full well that you share my 

commitment on this point, and that you are working with all of us at the NIH to uphold 

the highest standards that can rightfully be expected by the public, whose support has 

enabled us to make remarkable strides in biomedical science. The Subcommittee has 

been working with NIH on several important issues and concerns that must be addressed, 

and I welcome the opportunity to cooperate with you as you continue to do so. I have 

already met with Subcommittee staff on three occasions. Based on the information that 

has been made available to me, I have taken action to improve our management of 

clinical samples. I am already taking corrective actions. 

When I joined the NIMH in November 2002, I was impressed by the level of 

commitment to patients and families that was clearly so much a part of the culture of the 

Institute. NIH has been called the “crown jewel” of HHS, and I believe it is such a jewel, 

among other reasons, because of the dedication and skill of those who conduct research 

in our intramural program. It is because of them that we have made rapid progress 

against disabling diseases such as schizophrenia, bipolar illness, and depression. Our 

stakeholders, especially the families who struggle with these diseases, need us to do all in 

our power to ensure that science advances as rapidly as possible. At the same time, 

science—no matter how laudatory its objectives and results—must be conducted with the 

utmost emphasis on ethical standards, ensuring public trust and support. This is not 

negotiable. 

To assure that the science performed at NIMH is of the highest quality and meets 

stringent ethical standards, there are policies and procedures for the conduct of clinical 

research, including the management of clinical samples and interactions with industry. 

We realize that science and public policies change over time and that our rules and 

procedures must be continually scrutinized for relevance and effectiveness. Although I 
209

am confident in the high ethical standards held by our staff, we occasionally find serious 

problems can occur, as is the case in most large organizations. To the extent that 

problems result from systemic issues, I am working with the NIH leadership on 

institutional reforms. 

At NIMH we recognize that rapid progress requires collaboration, including the 

exchange of clinical samples, such as blood or cerebrospinal fluid. As these samples are 

a non-renewable resource from patients involved in clinical studies, the management of 

these samples is an important aspect of our stewardship of the public trust. The following 

points may help the Committee understand our approach to this stewardship: 

• Federal regulations require both Institutional Review Board (IRB) approval and 

informed consent, unless waived by the IRB, before a proposed study involving 

human subjects can begin. 

• Samples derived from clinical studies conducted at the NIH are Government 

property under the responsibility and accountability of chief of the pertinent 

Laboratory or Branch. The use of these samples is part of our obligation to 

research volunteers, who are our partners in the discovery process. 

• When a trainee or non-tenured investigator leaves the NIMH, the disposition of 

the clinical samples collected by that junior investigator remains the 

responsibility of the Laboratory/Branch chief. When the Laboratory/Branch 

chief leaves, the disposition of the clinical samples becomes the responsibility 

of the Institute’s Scientific Director, who is also the director of the NIMH 

Division of Intramural Research Programs. 

• Collaboration with non-government scientists in the private sector is 

encouraged as part of an intramural research scientist’s official duty. This 

means that work with industry is done on official time and without nongovernment compensation. In the past, consultations with industry were 

permissible, subject to prior approval, if no Federal resources were used, no 

conflict or subject matter overlap with official duties was identified, and no 

other ethics concerns were present. 

• Investigators with potential conflicts of interest are required to disclose these 

potential conflicts to the IRB as part of the review process. Like all executive 

branch employees, investigators who conduct clinical research generally may 

not participate in official matters in which they have a financial interest. 

• The exchange of clinical samples may be an important aspect of collaboration. 

NIH is enhancing policies pertaining to the handling of human tissue samples 

and related intellectual property. At NIMH, I believe we have not done enough 

to ensure that all clinical samples leaving from or arriving at the Institute were 

adequately monitored. And, while the NIH has a variety of possible written 

mechanisms (including the Cooperative Research and Development Agreement 

(CRADA), the Material Transfer Agreement (MTA), and the Simple Letter 

Agreement(SLA)), these mechanisms have not been used uniformly within the 

NIMH. 

• Current policies require that surplus tissue samples from completed studies 

need to be monitored through continuing IRB review if the samples are linked 

to patient identifiers. Although all of our intramural scientists engaged in 

clinical research are required to complete training in human subjects 

protections, I am concerned that NIMH investigators may not be uniformly 

aware of when the use of stored samples requires IRB review. 

To address these concerns, I have done the following: 
210

• On May 2, 2006, I called an intramural faculty meeting to review current 

policies and expectations for the handling of clinical samples. 

• On May 26, 2006, the NIMH’s Acting Clinical Director, Dr. Donald 

Rosenstein, and I sent a follow-up memo to all intramural scientists to remind 

them of the current policies and expectations. Specifically, we are requiring 

that all collaborations involving clinical samples be documented with a written 

agreement (e.g., CRADA, MTA, or SLA) and that these agreements be crossreferenced for potential conflicts of interest. 

• Some of the clinical samples stored at the NIH are from studies that have been 

completed, meaning that they are no longer enrolling subjects and analyzing 

data. We are in the process of reviewing all collaborations using stored 

samples from both active and inactive studies by intramural clinical scientists 

to ensure that they have appropriate approval and documentation. For stored 

clinical samples of a completed study, we are requiring all investigators to have 

an active IRB-approved protocol with continuing review to permit monitoring 

of these samples. 

 It is important for the Subcommittee to realize that although standards and policies 

for clinical research and collaborations with the private sector have changed over time, 

certain rules of conduct have remained constant. NIH scientists have always been 

required to abide by the general principles of government service. It is a public trust 

requiring employees to place the public health over private gain. We need to be sure we 

provide NIH staff with the tools they need to maintain this high standard. 

 Mr. Chairman and members of the Subcommittee, thank you for taking the time to 

look into these issues at the NIH and the NIMH. We are very proud of the 

accomplishments that have been made by the NIH, and the fundamental and profound 

role the agency and its scientists have played in alleviating suffering from disease. We 

are in a unique position because not only do we have to answer to our primary 

stakeholders—our patients and their families—but we have to answer to you and to every 

member of the public who has entrusted us with their hard-earned dollars to carry out 

NIMH’s profound yet straightforward mission: to reduce the enormous burden of mental 

illness and behavioral disorders through research on mind, brain, and behavior. 

I will be pleased to answer any of your questions. 

 MR. WHITFIELD. Thank you, Dr. Insel. At this time we will 

recognize Dr. Friedman for his 5 minute opening statement. 

DR. FRIEDMAN. Mr. Chairman, members of the committee, thank 

you for the opportunity to come before you today to discuss the facts 

relating to the use of cerebrospinal fluid and plasma samples in 

collaboration between Dr. Sunderland at the NIMH and Pfizer, Inc. 

 I have great respect for the work of this subcommittee and the 

process of scrutiny underlying this hearing as I believe they will serve to 

clarify issues and resolve questions about the process and the intent of 

these key studies. 

 I am appearing before you for several reasons. First, I have firsthand 

information regarding some of the scientific issues relating to the 

interaction between Pfizer and Dr. Sunderland. As an employee of 

Pfizer from 1995 to 2001, I initiated discussions between Dr. Sunderland 

and Pfizer regarding a possible scientific collaboration to search for and 
211

evaluate possible biomarkers of Alzheimer’s disease. Second, I have 

great respect for Dr. Sunderland as a scientist and clinician for his 

contributions to this important basic research. I also have great respect 

for each of the key contributors of these experiments including my 

former Pfizer colleagues and the NIMH staff and associates of Dr. 

Sunderland who participated in the effort. 

 I also recognize and respect the important contribution of the 

individual Alzheimer’s patients and their respective families who 

contributed important CSF and plasma samples and underwent extensive 

testing over the past few decades resulting in the data and samples that 

are the subject of the discussion today. 

 Finally, I appear today in part because not doing so might be 

misinterpreted as not supporting the nature, process, and intent of this 

research effort. 

 I would like to make a few brief comments on the intent of this study 

as it relates to the issue of biomarkers. The information we sought in this 

experiment was essential to enable several medically important aspects 

of Alzheimer’s disease treatment, a goal with enormous significance to 

patients, their families, and society as a whole. We sought to uncover 

new tools to enable the diagnosis and early detection of Alzheimer’s 

disease. These tools are viewed as essential in the development of new 

therapeutics due to the current limitations in the unequivocal diagnosis of 

Alzheimer’s disease. We also sought biomarkers for disease progression 

rate as well as biomarkers to stratify patients by specific disease stages. 

Last, we sought to identify markers of apparent normal individuals 

exhibiting no measurable cognitive defect who were at risk of developing 

Alzheimer’s disease as a result of family history and/or genetic 

predisposition to the disease. This in turn might enable the treatment of 

cognitively normal yet affected individuals prior to their slow, 

progressive, debilitating decline. 

 It is important to recognize that these classes of markers serve 

several important roles. First, they facilitate and enable the proper 

clinical testing of potential Alzheimer’s therapeutics under currently 

approved FDA guidelines. Second, they may enable and inform 

regarding the proper clinical diagnosis of patients by the general medical 

community and may facility the appropriate determination of medication 

for an individual’s specific stage of disease. Finally, when these 

medications become available, these markers can also serve to enable 

physicians to individually monitor the response of their patients to ensure 

optimal and cost-effective treatment. 

 Given the magnitude of the societal burden of Alzheimer’s disease 

now and in the near future, these are important tools to be uncovered and 

developed. Dr. Sunderland recognized the significance of biomarkers 
212

and actively sought to identify biochemical markers as well as other 

types of markers in order to treat patients more effectively consistent 

with his role as an academic clinician at the NIMH. This was clearly 

obvious from his academic publications which in turn was the vehicle 

through which I as a Pfizer employee initially contacted him regarding 

an effort to uncover these important tools to assist in the diagnosis and 

treatment of Alzheimer’s patients. 

 Thank you for the opportunity to testify, and I would be happy to 

answer any questions regarding these issues. 

 [The prepared statement of David L. Friedman, Ph.D. follows:] 

THE PREPARED STATEMENT OF DAVID L. FRIEDMAN, PH.D. 

Mr. Chairman and Members of the Subcommittee, thank you for the opportunity to 

come before you today to discuss the facts relating to the use of cerebrospinal fluid (CSF) 

and plasma samples in a collaboration between Dr. Sunderland, at the NIMH, and Pfizer 

Inc. I have great respect for the work of this Subcommittee and the process of scrutiny 

underlying this hearing, as I believe that it will serve to clarify issues and resolve 

questions about the process and intent of these key studies. 

I am appearing before you for several reasons. First, I have first-hand information 

regarding some scientific issues relating to the interaction between Pfizer and Dr. 

Sunderland. As an employee of Pfizer, from 1995 to 2001, I initiated discussions between 

Dr. Sunderland and Pfizer regarding a possible scientific collaboration to search for and 

evaluate possible biomarkers of Alzheimer’s disease. 

Second, I have great respect for Dr. Sunderland as a scientist and clinician and for 

his contributions to this important basic research. I also have great respect for each of the 

key contributors to this experiment, including my former Pfizer colleagues, and the 

NIMH staff and associates of Dr. Sunderland who participated in this effort. I also 

recognize and respect the important contribution of the individual Alzheimer’s patients 

and their respective families who contributed important CSF and plasma samples and 

underwent extensive testing over the past few decades, resulting in data and samples that 

are the subject of the discussion today. 

Finally, I appear here today in part because not doing so might be misinterpreted as 

not supporting the nature, process, and intent of this research effort. 

I would like to make a few brief comments on the intent of the study as it relates to 

the issue of biomarkers. The information we sought in this experiment was essential to 

enable several medically important aspects of treatment of Alzheimer’s disease, a goal 

with enormous significance to patients, their families and to society as a whole. 

Specifically: 

• We sought to uncover new tools to enable the diagnosis and early detection 

of Alzheimer’s disease. These tools are viewed as essential in the 

development of new therapeutics due to the current limitations in the 

unequivocal diagnosis of Alzheimer’s disease. 

• We also sought to identify biomarkers for disease progression rate, essential 

to conduct cost-effective and efficient clinical drug trials given the 

heterogeneity of progression rates within this patient population. 

• We also sought biomarkers to stratify patients by specific disease stages, 

knowing that various disease stages were likely to manifest differing 

components of the disease process and thus the potential to respond to 

different classes of therapeutics. 
213

• Last, we sought to identify markers of apparently normal individuals, 

exhibiting no measurable cognitive defect, who were at risk of developing 

Alzheimer’s disease as a result of family history and/or genetic 

predisposition to the disease. This in turn might enable the treatment of 

cognitively normal yet affected individuals prior to their slow, progressive, 

and debilitating decline. 

It is important to recognize that these classes of markers serve several important 

roles. 

• First, they may facilitate and enable the proper clinical testing of potential 

Alzheimer’s therapeutics under currently approved FDA guidelines. 

• Second, they may enable and inform regarding the proper clinical diagnosis 

of patients by the general medical community, and may facilitate the 

appropriate determination of medication for an individual’s specific stage of 

the disease. 

• Finally, when these medications become available, these markers can also 

serve to enable physicians to individually monitor the response of their 

patients to insure optimal and cost-effective treatment. 

Given the magnitude of the societal burden of Alzheimer’s disease now and in the 

near future, these are important tools to be uncovered and developed. Dr. Sunderland 

recognized the significance of biomarkers and actively sought to identify biochemical 

markers as well as other types of markers in order to treat patients more effectively, 

consistent with his role as an academic clinician at the NIMH. This was clearly obvious 

from his academic publications, which in turn was the vehicle through which I, as a 

Pfizer employee, initially contacted him regarding an effort to uncover these important 

tools to assist in the diagnosis and treatment of Alzheimer’s patients. 

Thank you for the opportunity to testify today. I would be happy to answer any 

questions you may have regarding this matter. 

 MR. WHITFIELD. Thank you, Dr. Friedman. 

 As you know, this subcommittee had a hearing in 2004 related to this 

overall issue and as a result of that, NIH and HHS both revisited and 

dramatically strengthened their ethics regulation, I believe in 2005. The 

question I would like to start off with, Dr. Insel, for you is, the period we 

are talking about relating to the spinal fluid transfer to Pfizer and Dr. 

Sunderland is roughly 1995 to 2001, in that general time frame, but at 

that time certainly the Institute encouraged collaboration with outside 

researchers. I mean, you can’t do your job without doing that. So I am 

assuming that throughout the entire NIH, it was totally acceptable for 

scientists to have outside consulting agreements with private firms. Is 

that correct or is that not correct? 

 DR. INSEL. Just to clarify, Mr. Chairman, there was encouragement 

for collaboration with both academic and private scientists but what you 

have asked about in terms of consulting arrangements was seen as 

something different than collaboration, so consulting arrangements with 

anyone outside of the Federal government comes into a very different 

category. It could be approved but it would require approval and review. 
214

 MR. WHITFIELD. But it was not unusual for scientists to have 

outside consulting agreements? 

 DR. INSEL. It was not by any means unusual, but I just want to make 

sure we are clear about what we are talking about here. You could have 

both collaboration and you could have consulting agreements, but you 

couldn’t have them with the same agent. 

 MR. WHITFIELD. With the same agent? 

 DR. INSEL. That is right. 

 MR. WHITFIELD. You mean with the same outside party or--is that 

what you are referring to? 

 DR. INSEL. That is correct. 

 MR. WHITFIELD. Okay. Now, before I get to Dr. Sunderland, let me 

ask you, any outside agreement that you had as a consultant, there would 

have to be disclosure of that agreement, I am assuming? 

 DR. INSEL. There is a whole system that would include prior 

approval--it would include review, approval, and then disclosure would 

be the minimal. 

 MR. WHITFIELD. So that protocol was already in place that you had 

to have the review, the approval and so forth, correct? 

 DR. INSEL. That protocol has been in place but I think as you know, 

beginning in 2005 there was first a moratorium on any outside activities, 

and in August of 2005 a new set of guidelines that now completely 

restrict outside activities and they are not permitted with either a 

pharmaceutical company or with biotech. 

 MR. WHITFIELD. Okay. Dr. Sunderland had executed a material 

transfer agreement with Pfizer in 1998. He also had the consulting 

agreement with Pfizer in 1998. At that time was that permissible under 

existing NIH policies? 

 DR. INSEL. It would not have been approved to have a consulting 

agreement and an outside activity with the same company at that time. 

 MR. WHITFIELD. Okay. So that would be a violation of the rules 

and regulations of the NIH at that time? 

 DR. INSEL. I wasn’t here in 1998 but what I have been told is that 

that would not have been approved. 

 MR. WHITFIELD. Was it permissible under NIH policies in 1998 to 

provide human research samples from NIH labs to a drug company and 

have a consulting arrangement with that same drug company about those 

samples? 

 DR. INSEL. No, that is not--that again is the same issue. It is mixing 

collaboration and consulting, and that is where we get into this overlap 

between the scientific official duty of one of our researchers and their 

having some outside income from the same source. 
215

 MR. WHITFIELD. Right. Now, when we get into patent rights, could 

you briefly explain--with the caliber of the research that is going on and 

the new avenues that you are moving, it is not unusual to be involved in 

new patients. Could you briefly explain the policy of NIH as it relates to 

patent rights and the involvement of a scientist on your staff with an 

outside firm regarding patent rights? 

 DR. INSEL. Yes, of course. Ms. Winfield may be able to fill you in 

more from the Office of Technology Transfer’s perspective because she 

does this for a living, but the opportunity to take discoveries and have 

them licensed is something that the NIH understands, appreciates, and 

encourages, and sometimes that can be done through collaborative 

activity. It is important for the subcommittee to realize that we are 

encouraging that kind of activity and we are encouraging it as official 

duty. We want people to work with industry to make discoveries and we 

want them to do that on government time. In the case where a discovery 

could be licensed, there is an opportunity to pursue that through the NIH. 

We have a technology transfer office that has a very well-developed set 

of guidelines about how that can be done. 

 MR. WHITFIELD. Well, I know that Dr. Sunderland, for example, 

assigned his patent rights and was listed on Pfizer’s patent application as 

a co-inventor and I know he received no money for that, so was there 

anything wrong with that? 

 DR. INSEL. So--let me back up a moment. What you are telling me 

is that he was on a patent application that he received no money for. We 

have no record in the NIH of a patent application with Pfizer or anyone 

else from Dr. Sunderland. 

 MR. WHITFIELD. Okay. So you have no record of that? 

 DR. INSEL. So is that a problem for us, for any investigator? Let us 

take it away from this case, but to discover that someone has an 

application for a patent either with a private collaborator or without that 

relates to their official duty as a Federal employee and our agency 

doesn’t know about it? Yes, that is a problem. 

 MR. WHITFIELD. Okay. Why is that a problem? 

 DR. INSEL. So what you are talking about is trying to license for 

potential commercial gain a discovery or an invention made through your 

Federal employment, and the Federal government has a stake in that. 

That is no different than if you as a Member of Congress decided to take 

something that was part of your official duty as a Congressional 

Representative and to create it as an invention and try to have it licensed 

on the side without telling anyone from Congress about that. 

 MR. WHITFIELD. Dr. Friedman, you were with Pfizer from 1995 to 

2001? 

 DR. FRIEDMAN. Yes. 
216

 MR. WHITFIELD. And what were your responsibilities there? 

 DR. FRIEDMAN. I was part of an emerging biomarker group. 

Because of my doctorate in neuroscience, I had the responsibility for 

looking for alternative strategies for developing Alzheimer’s 

therapeutics. I was also part of a committee to look for new technologies 

that were enabling in terms of identifying new biomarkers across a 

spectrum of disease areas. 

 MR. WHITFIELD. But the research was focused on Alzheimer’s? 

 DR. FRIEDMAN. No, the research I was doing was focused on 

biomarkers for a number of neurological diseases including head trauma 

and depression. 

 MR. WHITFIELD. And when did you first have contact with Dr. 

Sunderland about obtaining the spinal fluid from NIH? 

 DR. FRIEDMAN. I first contacted Dr. Sunderland late in 1997, having 

spent a year on this committee looking for new technologies and 

realizing that it would be possible to do these experiments. We then 

sought a partner who had the experience and knowledge and access to 

samples that would make this project possible, so it was in the fall of 

1997. 

 MR. WHITFIELD. And you all entered into a material transfer 

agreement with him to obtain these samples? 

 DR. FRIEDMAN. Pfizer did in 1998, yes. 

 MR. WHITFIELD. And at that time was there a consulting agreement 

in effect between Pfizer and Dr. Sunderland? 

 DR. FRIEDMAN. I wasn’t part of any of the contracts or negotiations 

regarding the contracts. Having participated in these types of 

collaborations before, it was not unusual to have a consulting 

arrangement as part of a collaboration, but in no way was I part of those 

discussions. 

 MR. WHITFIELD. So from your personal knowledge, you were not 

aware of that? 

 DR. FRIEDMAN. Well, not only that, but it wasn’t my role as a 

scientist. 

 MR. WHITFIELD. Right. How would you describe the success of the 

research that you conducted or that Pfizer was involved in relating to its 

efforts with NIH on this Alzheimer’s project? 

 DR. FRIEDMAN. It is kind of a complicated question because there 

are multiple facets to that project, and so if you want me to speak in 

general about those? 

 MR. WHITFIELD. The one with the unknown biomarkers. 

 DR. FRIEDMAN. Okay. So that was the project we did in 

collaboration with an external partner, Oxford Glycoscience. That 

project where we are looking for unknown markers has in its technical 
217

feasibly not been matched today. It was a huge effort to look for lowabundance markers in cerebrospinal fluid. It led to the identification of 

over 100 proteins that were likely stage-specific in terms of their release 

into the cerebrospinal fluid. The follow-up of that process is ongoing. I 

happen to know by looking at the patent literature that those patents have 

been updated the past couple of years so it looks as though Pfizer is 

actively pursuing not only the identification but the validation of those 

markers which takes several years, so I would view it as being highly 

successful. 

 MR. WHITFIELD. Right. I see my time has expired, so Mr. Stupak, I 

will recognize you for 10 minutes. 

 MR. STUPAK. Thank you, Mr. Chairman. Dr. Friedman, you 

indicated that you are familiar with the MTAs and the CRADAs that they 

use? 

 DR. FRIEDMAN. No, I indicated I wasn’t familiar with them. I 

wasn’t part of the process of-- 

 MR. STUPAK. But I mean, outside of Dr. Sunderland, were you 

familiar with them? 

 DR. FRIEDMAN. No, I am actually familiar with doing collaborations 

with academic investigators as part of my role, not just at Pfizer but at 

other drug companies as well. It is not an unusual process, to say the 

least. What I indicated-- 

 MR. STUPAK. Let me ask you this. I am looking at Exhibit #15 in 

the book there, and this is an e-mail and you are carbon-copied on it, and 

you talked about “pleased that this is working out well both on the 

scientists’ side and on the tech transfer side. We do not need to have an 

MTA signed prior to CMC on March 12, Julie.” And it sort of goes 

through this meeting, and according to our understanding, you were at 

this meeting on February 28 when you went to see Dr. Sunderland. Do 

you remember the meeting of February 20, 1998, when you went to 

meet-- 

 DR. FRIEDMAN. In general I do. 

 MR. STUPAK. Okay. Do you remember seeing this e-mail? 

 DR. FRIEDMAN. I have seen the e-mail several times, once obviously 

back then but also subsequently during my prior visits to begin 

discussions about my role. 

 MR. STUPAK. Well, my concern is, in this e-mail it says, “In 

discussions regarding Pfizer’s needs and Sunderland’s needs, Trey 

indicated he was very happy with MTA arrangement plus consulting that 

Kathy Smith has been discussing. Trey was also very interested in 

publication in a reasonable timeframe and that he wanted to make sure 

that authorship would be based on scientific and intellectual 

contributions. We indicated agreement on both matters.” It seems to me 
218

that on February 20 from reading this e-mail and the whole of it, not just 

the part I quoted, that there were discussions about payment and things 

that Pfizer would receive from Dr. Sunderland. Is that correct? 

 DR. FRIEDMAN. Yes, it is correct. I was-- 

 MR. STUPAK. Didn’t you think that was unusual, that you would be 

paying a scientist at NIH--or NIMH--excuse me--for his samples and 

things like that? 

 DR. FRIEDMAN. First of all, this meeting was a mixture of both 

business and scientific people from Pfizer, so Kathy Monahan was part 

of the business end of the process. 

 MR. STUPAK. You were there and three other Pfizer scientists? 

 DR. FRIEDMAN. Yes. Correct. I was there because I had initially 

made contact with Dr. Sunderland and we had established a scientific 

relationship. We had even begun the discussion about the collaboration 

prior to-- 

 MR. STUPAK. Yeah, but it says “take care of Pfizer’s needs and 

Sunderland’s needs.” 

 DR. FRIEDMAN. Those comments were actually from Kathy Smith 

regarding her interpretation of how the discussions about future-- 

 MR. STUPAK. You didn’t think that was what happened at that 

meeting? 

 DR. FRIEDMAN. No, I didn’t say that at all. I can’t say clearly that at 

the time and even until recently, I don’t know the difference between a 

CRADA and an MTA in terms of the implications. 

 MR. STUPAK. What did you understand Dr. Sunderland’s need 

would be then? 

 DR. FRIEDMAN. I didn’t try and interpret what his need would be. 

 MR. STUPAK. What were Pfizer’s needs at the time of the February 

20, 1998, meeting? 

 DR. FRIEDMAN. In a business sense, I don’t know. From a scientific 

sense, we were looking for someone who had well-characterized 

samples. We were looking for someone who was an expert in the field 

of Alzheimer’s disease because without the combination of those, the 

efforts that we would put forth would be worthless. 

 MR. STUPAK. Did you think it was odd that you would be paying for 

these samples? 

 DR. FRIEDMAN. I didn’t--in no way did I interpret that we were 

paying for the samples. We were paying for the opportunity to have a 

collaboration with Dr. Sunderland and in no way did I know what the 

specifics of this type of-- 

 MR. STUPAK. So you are saying all this money that Pfizer paid, it 

wasn’t for the sample, it was for the opportunity to work with Dr. 

Sunderland? 
219

 DR. FRIEDMAN. That is my interpretation, yes. 

 MR. STUPAK. Really? 

 DR. FRIEDMAN. Exactly. 

 MR. STUPAK. Were samples just thrown in then as good faith or 

something? 

 DR. FRIEDMAN. I don’t think you can put a value on the samples. In 

spite of the discussion yesterday, I think any attempt to try and do that 

type of analysis is impossible. 

 MR. STUPAK. The most important thing was really the samples, 

weren’t they? 

 DR. FRIEDMAN. No, the samples are actually useless without the 

clinical information associated with them. They were-- 

 MR. STUPAK. Couldn’t you ake the samples and have them analyzed 

and have other labs take a look at it depending on what you are trying to 

do with those samples? 

 DR. FRIEDMAN. Alzheimer’s-- 

 MR. STUPAK. There was a great benefit to Pfizer, wasn’t there? 

 DR. FRIEDMAN. Alzheimer’s is a very complex disease. Knowing 

what type of patients these came from is almost as valuable as knowing-- 

 MR. STUPAK. Well, not just the patients but also the patient’s 

extended family, blood relatives, some who had-- 

 DR. FRIEDMAN. Absolutely. All of that data is critical to interpret 

the biochemical measures that we were acquiring as part of this 

collaboration. We would never have ventured into this without having 

that complete set of information because otherwise it would be 

uninterpretable. 

 MR. STUPAK. Do you know if Pfizer had other MTAs or CRADAs 

with NIH? 

 DR. FRIEDMAN. With NIH? 

 MR. STUPAK. Yes. 

 DR. FRIEDMAN. I wasn’t aware, but I wouldn’t be surprised if they 

did. 

 MR. STUPAK. But the samples and the clinical data were transferred 

under the MTA. In fact, Pfizer was upset because they were transferred 

in June and they didn’t get the data until August, right? 

 DR. FRIEDMAN. I wouldn’t characterize it as Pfizer being upset. 

There were probably members of this project who were more concerned 

with timelines that were upset about the timing of it but the scientists as 

part of the project recognized that we would need 6 months at least to 

acquire that type of biochemical data prior to integrating it with the 

clinical data to interpret it. 

 MR. STUPAK. You said you are the one who sort of initiated the 

conversation with Dr. Sunderland and Pfizer, correct? 
220

 DR. FRIEDMAN. Yes. 

 MR. STUPAK. Before you introduced Dr. Sunderland to other Pfizer 

officials, did you have conversations with him about what his role would 

be in this research? 

 DR. FRIEDMAN. Yes. Can I clarify what that conversation was? 

 MR. STUPAK. At any time did money come up during that time as-- 

 DR. FRIEDMAN. No, never. 

 MR. STUPAK. --payment for samples or for data? 

 DR. FRIEDMAN. It was a discussion of a scientific collaboration 

only. 

 MR. STUPAK. And do you know how money came up in this whole 

opportunity or this-- 

 DR. FRIEDMAN. I wasn’t part of those discussions. 

 MR. STUPAK. Who at Pfizer would be? 

 DR. FRIEDMAN. Kathy Smith would probably be one person. Barry 

Hess would be another. 

 MR. STUPAK. Dr. Insel, according to our information, Dr. 

Sunderland is still on the payroll at NIH? 

 DR. INSEL. That is correct. 

 MR. STUPAK. Is any action being taken? 

 DR. INSEL. His case, as you know, was reviewed by the Office of 

Management Assessment as part of conflict-of-interest concerns. There 

was a recommendation made, and the case was referred to the 

Commissioned Corps of the Public Health Service. He is technically a 

Commissioned Corps employee. 

 MR. STUPAK. So the recommendation was made. When was that--to 

the Corps? 

 DR. INSEL. I sent that forward I believe on November 21, 2005. 

 MR. STUPAK. Two thousand five. As far as you know, did anything 

happen on that recommendation? 

 DR. INSEL. I have called and sent notes subsequently and as far as I 

know, there is no decision made yet by the Commissioned Corps. 

 MR. STUPAK. What was your recommendation? 

 DR. INSEL. My recommendation, which I believe you have in your 

package, was, I sent forward the Office of Management Assessment 

review--essentially it was about a five-page set of findings--and I gave 

them a one-paragraph cover note saying that I was really disappointed, 

that I thought of Dr. Sunderland as one of the people who had made 

tremendous contributions to the agency, but that I had been informed by 

the Office of Management Assessment that civil service employees who 

had similar levels of violations would have been recommended for 

termination. 

 MR. STUPAK. So were you recommending his termination? 
221

 DR. INSEL. I can’t actually do that, sir. I don’t have the authority. 

 MR. STUPAK. I am not asking if you terminated him. I am asking if 

you made a recommendation that he should be terminated. 

 DR. INSEL. Well, I tried to explain exactly what I said, that I told 

them that given the severity and the concerns about these findings, that 

had he been in the civil service, he would have been likely terminated 

based on what I had been told by the Office of Management Assessment. 

They will have to make their own determination about that at the 

Commissioned Corps. 

 MR. STUPAK. So you don’t want to make a recommendation then? 

 DR. INSEL. In fact, I can’t. I can’t do any more than refer the case-- 

 MR. STUPAK. How about Dr. Molchan? Would you be her 

supervisor? 

 DR. INSEL. I am not Dr. Molchan’s supervisor. 

 MR. STUPAK. If she was to get tenure, would you be involved in the 

process of whether or not she would receive tenure at NIH? 

 DR. INSEL. She is currently in the National Institute of Aging, so I 

wouldn’t have anything to do with that. If she were to come back to the 

National Institute of Mental Health and she were a tenured investigator, I 

would be involved as in my current temporary role as the Acting 

Scientific Director for about another month. 

 MR. STUPAK. So accountability then would depend upon the 

institute? The National Institute of Mental Health, that would have had 

the accountability? 

 DR. INSEL. Let me ask you to unpack that a little bit more in terms 

of accountability. Accountability for what in this case? 

 MR. STUPAK. Well, in this case let us say Dr. Sunderland. He is a 

Corps individual so you don’t have any control over that, right? 

 DR. INSEL. Right. 

 MR. STUPAK. So who would have accountability over him? 

 DR. INSEL. Well, this is where it gets complicated. So indeed he is 

an employee of the Commissioned Corps. He is essentially detailed to 

the National Institutes of Health where he has been for some 24, 25 

years. His supervisor is the Scientific Director of the Institute and so-- 

 MR. STUPAK. Of NIH? 

 DR. INSEL. Of NIMH in this case, so we are one of 27 components 

of the NIH, and NIMH has-- 

 MR. STUPAK. Well, let us put it like this. We find it a little funny on 

this side of the dais that Dr. Sunderland seems to still be working and 

does not seem to have any problems but the person who came to the 

committee with her concerns cannot get tenure at NIH, so we have some 

real questions here on this side so I guess I am trying to figure out who is 

making these-- 
222

 DR. INSEL. Let me tease these two things apart. You say you find it 

a little funny that he is still there and there is-- 

 MR. STUPAK. I find it suspicious. 

 DR. INSEL. I actually find it a real concern. This has been 2 years 

since you have given us some information. We have done a very 

thorough review. We made some recommendations. We made a 

referral. We are now 7 months down the road and this gentleman is still 

waiting to find out about his fate. I would separate that from the 

question about tenure of another scientist. Now, the decision about 

tenure-- 

 MR. STUPAK. Now, the witness yesterday said that her supervisors 

were discouraging her from talking to the committee or discouraging her 

from blowing the whistle, if you will, and then when we find she doesn’t 

receive tenure, I guess that is--we find that suspicious. 

 DR. INSEL. So if I may, if I can back up. 

 MR. STUPAK. Sure. 

 DR. INSEL. She was an employee of the NIMH until I believe 1996, 

1997. At that point in time she was not on what we call a tenure track. 

That is, she was essentially in a training position but an extended one. 

She did apply for a tenure-track position. It is my understanding that was 

done in 1997 and that is a competitive process both internal and external. 

The NIMH, before they would--or NIH, before they would give tenure to 

an intramural scientist, they are going to do a very though competitive 

process to make sure we have got the best and the brightest person. 

 MR. STUPAK. Sure. We find it amazing or amusing that she has 50 

co-authored reports with Dr. Sunderland and nothing happens to him but 

she doesn’t get her tenure and she is still waiting, but all those reports for 

one seem to be beneficial. 

 MR. WHITFIELD. The gentleman’s time has expired. 

 MR. STUPAK. Thank you. 

 DR. INSEL. I would be happy to respond to that if I may. 

 MR. WHITFIELD. Okay. 

 DR. INSEL. All I can say that in the tenure process, it may seem 

ironic to you, but in fact, having 50 papers with your supervisor is not a 

plus. You are looking for someone who is an independent thinker, who 

has created their own area of research, who can come in and function 

independently with their own resources, which is what we define as 

tenure track or tenure. She certainly was considered in that process. He 

had nothing--he was not on that committee. Obviously this is done by an 

independent group. They did have a short list. My understanding is that 

she didn’t make the short list and that happens all too often. 
223

 MR. WHITFIELD. We will go ahead, and if we have time, we will 

come back with some more questions. Dr. Burgess, you are recognized 

for 10 minutes. 

 MR. BURGESS. Thank you, Mr. Chairman. 

 Yesterday during our questioning, the issue came up. Dr. Molchan 

said that this concept of the lithium study was one that she brought to the 

lab. It was not a project she was assigned after arriving there. But then 

when the contract or whatever expired and she leaves the lab, is that 

unusual then for that particular arm of research just to stop and no one to 

pick it up and continue that? Would that be the standard operating 

procedure of the NIH in that type of situation? 

 DR. INSEL. So if I may answer, it is a very in some ways 

complicated question because it depends on the individual lab and the 

individual project, but if I can speak to this particular case, I think it is 

important for the subcommittee to recognize that that was a study that 

essentially stopped accruing patients early in 1993. She did submit 

annual progress notes to the Institutional Review Board and the one in 

1995 says that she would like to keep the study open even though it has 

been capped. She hasn’t brought anybody else in 2 years because she 

thinks there may be an opportunity to do additional studies. But in 

August 8 of 1996, she actually sends a note in the annual note to the 

board saying that she would like to now terminate the study. She leaves 

the Institute, as I understand it, in 1997. Now, remember, there has been 

no additional accrual of patients since 1993 and there have been some 

papers published in the meantime, but she goes off and leaves for another 

agency, which is not actually a discovery agency like the NIH, it is a 

regulatory agency, the FDA, and as she said yesterday, I think my 

understanding was that this was her project, that wasn’t a project of her 

supervisor’s, one that she brought forward, so I don’t think in a case like 

that it would be surprising after the person who had initiated the project 

decided to terminate it, that no one else decides that they want to pick up 

on it. That is my understanding of how this took place. 

 MR. BURGESS. If I understood the tone of questioning correctly 

yesterday from the committee, there seemed to be a sense that there 

should be some type of central database for sensitive or delicate tissue 

samples and that someone at NIH should oversee that. Now, I tried to 

get a sense from Dr. Molchan as to how many blood, urine, tissue 

samples there might be housed in the various refrigerators and 

warehouses at the NIH just in the intramural part here in Bethesda, and I 

really no one would even hazard a guess at a number, but I would 

suspect those numbers of samples must be in the millions to tens of 

millions when you think of all of the test-tube racks and all the 

refrigerators and all the freezers contained in all those buildings out 
224

there. Mr. Chairman, I might point out, all those buildings are named for 

appropriators, not authorizers, as we reconsider the reauthorization of the 

NIH. 

 But is there currently any type of central way that you keep track of 

this? If someone were to go out there today and start a spinal fluid study 

on Alzheimer’s patients, would those samples be logged in, coded, and 

someone keep track of that over time? 

 DR. INSEL. So the investigator, and by that we could be talking 

about a lab chief or a staff scientist who is involved, would have a 

tremendous investment in the samples they are collecting, and we would 

expect them as part of their stewardship to do a very careful 

documentation of what they have and where they have it and how they 

are managing it. But the question you are asking, is there a central 

database, that is, of 54 scientists. Do they at some point pool all of their 

data on all of their freezers and refrigerators and what they have at any 

given time? The answer is no. 

 MR. BURGESS. And is it a reasonable expectation that this 

committee might have that that would ever be in place or is the problem 

just that the number of samples is just too large? 

 DR. INSEL. I think it is a really interesting question to consider, and I 

think part of what happens, and as the Chairman said, we are sort of 

looking at some of these policies through the prism of a single case. We 

want to make sure that whatever solutions we come up with don’t create 

problems of their own, and what you don’t want is a bureaucracy that 

makes it impossible to move quickly and to make discoveries in an 

environment like the NIH. At the same time you want to make sure you 

can manage what you have. As we often say, if you can’t measure it, 

you can’t manage it, so you have to know what is there and you have to 

be able to know what has been used and what still remains. 

 Up until this point, we have left it to the scientists themselves to 

make those determinations and then we review the scientists based on 

their stewardship. The question you are asking is, should we put 

something in place in the era where we have these large lab management 

software systems? Do we need that? Well, some of the institutes have 

been doing that and already they are putting those ideas out on the table 

and trying them out. Some of them have already taken them out on the 

road a bit to see how they work. Dr. Gottesman may tell you a little bit 

more about that. It is not as simple as it sounds. It is not necessarily the 

solution to all problems but I think at this point is one thing that we 

really want to look at very seriously, and we are in the process right now 

already in the last few weeks of pulling together inventory of everything 

we have got, making sure we know what has been used and what hasn’t 

and trying to figure out what would be the impediments to actually 
225

coming up with the kind of central database that actually might also 

articulate with other kinds of clinical research data that we have. So I 

think there is an opportunity here, and we actually owe it to the 

subcommittee-- 

 MR. BURGESS. I don’t want to interrupt you but my time is going to 

draw short. There are a couple things--I do want to explore this line of 

questioning a little further. Not commenting on the rightness or 

wrongness of what Dr. Sunderland did, would we even be having this 

discussion if those samples had been used and there had been a 

blockbuster breakthrough? I mean, myself as a taxpayer and a consumer 

of medical research at the other end, I might see that as a good thing and 

a worthwhile thing. Would we even be having this hearing if there had 

been a wonderful extrapolation of that data and we had seen the onset of 

Alzheimer’s delayed by ten years per patient? 

 DR. INSEL. Well, I appreciate that question. I do think that it is 

important to separate out scientific collaboration, which was an exciting 

and promising and I think very useful endeavor, from this question of 

conflict of interest. I think before you came in, I said the true north here 

has to be the question of separating out public role, official duty, from 

private gain, and if that wasn’t on the table, then we are here to 

congratulate Dr. Sunderland on having done I think a really excited 

scientific collaboration which as you heard from Dr. Friedman may 

actually bear some really important discoveries for families with 

Alzheimer’s disease. So the question of having actually worked with 

industry to come up with new biomarkers for Alzheimer’s, I think 

everybody would cheer him on to do that. 

 MR. BURGESS. Would it have been a tragedy if that breakthrough 

could have occurred and it didn’t occur because those samples sat in a 

freezer somewhere-- 

 DR. INSEL. Absolutely. 

 MR. BURGESS. --for 15 years? 

 DR. INSEL. I think it would be a real mistake to decide based on our 

considerations of these issues that when you have residual samples from 

a study like this that has been closed that we just dispose of them because 

they may have true value and could be used for discoveries. We have 

examples over and over again--hepatitis B, hepatitis C, AIDS where it is 

stored samples that have really brought out fantastic discoveries for 

human health. There is an opportunity to do that here and it still may 

happen. 

 MR. BURGESS. Let me ask you this, because it kept coming up 

yesterday. Is the scientist, the principal investigator under any obligation 

to go back to the person that sample is collected from and to reissue or 

redirect permission to study-- 
226

 DR. INSEL. Reconsent? 

 MR. BURGESS. Reconsent. Yes, sir. Thank you. 

 DR. INSEL. The obligation is not to reconsent but to be very clear is 

that if you have got samples that are stored for a study that has been 

terminated, we call those residual samples and you have got them in the 

freezer and you want to use them again for any purpose that involves 

research, it is not up to the scientist to decide whether that should go 

forward or not. We have a very clear new policy in place that says as of 

just the last few days that we want people to go back to the Institutional 

Review Board to let them know what new use they would like to make of 

remaining samples because we don’t want to leave that in the hands of 

the scientist. 

 MR. BURGESS. What would the policy have been when the original 

lithium study was closed in 1996 or 1997? 

 DR. INSEL. I think the policy there was just very general, and if 

someone--I could certainly understand how someone could say well, 

these samples were taken to study neurochemistry in the cerebrospinal 

fluid, we are studying neurochemistry in the cerebrospinal fluid for 

Alzheimer’s disease and could decide they might be used at that point in 

time. Remember, now, that would require additional review. 

 MR. BURGESS. But your new policy that is in place would not leave 

one person as being the final arbiter as to what to do with these 

potentially very valuable samples; there would be oversight by the 

Institutional Review Board. Is that correct? 

 DR. INSEL. Precisely. 

 MR. BURGESS. Thank you, Mr. Chairman. 

 MR. WHITFIELD. Thank you, Dr. Burgess. At this time I recognize 

Ms. DeGette for 10 minutes. 

 MS. DEGETTE. Thank you, Mr. Chairman. Dr. Insel, Mr. Burgess 

raised some thoughts in my mind about exactly what the IRB process is 

for these residual tissue samples, and you told him that it would be a 

shame if the result of this issue was that these samples were just 

destroyed, and I agree with you, but I also think, and you might know, I 

have introduced legislation about patient protections and all this, and you 

said we didn’t need a reconsent process. Now, as I understand it, in this 

situation the original tissue donors did give a consent process and it went 

through IRB review, right? 

 DR. INSEL. That is correct. 

 MS. DEGETTE. But I am not suggesting a reconsent process, which I 

think would be impracticable, but I do think in the original consent 

process, you need to have some kind of informed consent for the donor 

that these tissue samples may be used later on for some kind of a 

different experiment or process, correct? 
227

 DR. INSEL. Absolutely. You will hear later from Dr. Gottesman that 

we actually have a new policy that will come into place that has to do 

with having to define what is the disposition of either stored samples or 

samples following the termination of the protocol. 

 MS. DEGETTE. Right, and this has been a problem not just with the 

NIH but with other research institutions recently, correct? 

 DR. INSEL. That is right. 

 MS. DEGETTE. And then you said that you would--that for a 

subsequent study on these tissue samples that might be a different study, 

they would have to go back to the IRB, right? 

 DR. INSEL. So I should just clarify because I knew we were short on 

time. There are two options. In some cases--I should say three options. 

In a case like this where you are studying Alzheimer’s disease, I don’t 

know this but it very well may be that, for instance, the subjects in this 

lithium protocol were all dead by the time that the scientists wanted to 

use the samples. 

 MS. DEGETTE. Right. 

 DR. INSEL. That puts them into a very different class. 

 MS. DEGETTE. I know, but for a subsequent study. I am not talking 

about the consent anymore. I am talking about going back to have the 

subsequent study approved by an IRB. That is what you-- 

 DR. INSEL. Right. It would either need to go--well, it would go to 

the IRB to ask the question, does this require reconsenting, does this 

require review, should this even be done, and there may be-- 

 MS. DEGETTE. Just for the threshold issues, would that be a full IRB 

process or would that be like a threshold IRB process? 

 DR. INSEL. Right. These were questions that we are now 

entertaining. I might ask Dr. Rosenstein, who is really the expert on the 

IRB issue, to comment on this because this is exactly the discussion we 

have been having in the last few weeks. 

 DR. ROSENSTEIN. You are asking about IRB approval of new use of 

existing samples? 

 MR. WHITFIELD. Excuse me, Dr. Rosenstein. You are going to be 

testifying, so if you just stand up and raise your right hand. 

 [Witness sworn] 

 MS. DEGETTE. Right. Dr. Insel said in his statement to Mr. Burgess 

that for a new study using these leftover tissue samples that there would 

have to be some IRB process. I don’t have a lot of time and I have other 

questions for him, so if you can answer very quickly, I would appreciate 

it. 

 DR. ROSENSTEIN. The Federal regulations require that research with 

human samples undergoing initial and ongoing review by an IRB. The 

question has to do with what the ongoing review is for existing samples. 
228

That is the policy that has been clarified. Those regulations have been in 

place a long time but haven’t always been followed as completely as they 

should be. 

 MS. DEGETTE. And in fact, it wasn’t followed in this case, right? 

 DR. ROSENSTEIN. Correct. 

 MS. DEGETTE. Okay. Dr. Insel, let me get back to a couple of other 

things. Now, I think you testified earlier that you became the director of 

the National Institute of Mental Health in 2002, correct? 

 DR. INSEL. Yes. 

 MS. DEGETTE. And Dr. Sunderland at that time was a lab chief 

there, right? 

 DR. INSEL. Yes. 

 MS. DEGETTE. And so you were there in 2004 when we had our 

hearings in this subcommittee and we found out that there were what we 

thought then was around $500,000. Now we now it is over $612,000 in 

unreported payments to Dr. Sunderland, correct? 

 DR. INSEL. I haven’t seen all the numbers but I will accept those. 

 MS. DEGETTE. It was lots of money. Can I assume that you know 

what the payments were for or did you ask him what they were for? 

 DR. INSEL. Well, I have spoken with him about this but I have to 

clarify that. I had not seen the documentation of any consulting 

agreements until very, very recently, only in the last few days, so I 

couldn’t tell you what those payments were for at that-- 

 MS. DEGETTE. Why didn’t you see the--I mean, if this has been 

going on for 2 years? 

 DR. INSEL. Right. So, this came out originally in June of 2004 that 

this subcommittee brought this issue to the NIH and of course all of us 

began to move into high gear to try to understand what was going on 

here with some of our scientists. The NIH decided that there should be 

only one investigation NIH-wide and that investigation would be done by 

the Office of Management Assessment. We were told specifically not to 

pursue any of these questions with our own scientists, go back to work, 

make discoveries, continue to have an impact on human health-- 

 MS. DEGETTE. So you assumed that they were investigated? 

 DR. INSEL. Precisely. 

 MS. DEGETTE. And now why-- 

 DR. INSEL. Well, not only did I assume, I was--this was something 

that we all agreed would be done by one body. 

 MS. DEGETTE. Right, based on what you were told. I am not being 

critical. And so when you read those consulting agreements that he had 

or whatever they were 2 days ago, that was in preparation for this hearing 

today? 

 DR. INSEL. Right. 
229

 MS. DEGETTE. Okay. Now, you had testified earlier to Mr. 

Stupak’s question that you went through the whole process of how 

someone like Dr. Sunderland gets removed and so on and you told Mr. 

Stupak that you have concerns that it has taken so long to figure out a 

disposition of his situation. Would that be an accurate statement? 

 DR. INSEL. I have concerns. 

 MS. DEGETTE. What concerns are they? 

 DR. INSEL. Well, it just seems to me that in this case, it has taken 2 

years before there is any penalty or any decision made about someone’s 

career. I think that is an awful long time. 

 MS. DEGETTE. Especially in light of these egregious examples here, 

right? 

 DR. INSEL. Even if we didn’t have egregious examples, I really think 

that in the spirit of due process, we deserve and our scientists deserve 

resolution of some of these issues so that we can all move on. We need 

to heal as-- 

 MS. DEGETTE. Have you let your superiors know that, that they 

need to get some kind of a resolution of this case? 

 DR. INSEL. I have spoken to several people and--but you have to 

remember, this case is no longer in the National Institutes of Health. It is 

now sitting elsewhere. 

 MS. DEGETTE. I understand. Now, I want to ask you one more 

question. You were talking earlier about these computer programs that 

we have and ways that we can get central registries of these tissue 

samples and so on, and you were talking about--it sounds like your 

institute and the other institutes are at the very early stages of talking 

about how we catalog and cross-reference this data. Would that be 

accurate? 

 DR. INSEL. So we are at the early stages of talking about it in a 

systemic way. Individual large labs already do a lot of bar coding, a lot 

of lab management systems. This is being done. And as you heard 

yesterday from Dr. Molchan, Dr. Sunderland has an extremely good 

data-tracking system. That is not the problem here. So there are 

individual labs who are doing this very, very well. The question is, 

should we be doing it as an institution, as an agency. Should we have all 

that rolled into one interoperable database. 

 MS. DEGETTE. Well, I have had many, many short and long 

conversations with Dr. Zerhouni, and as you know, with the NIH 

reauthorization, his concept is more centralization of funding and more 

cross-institute collaboration on research which I happen to agree with 

that vision, but it seems to me if we don’t even have the basic 

mechanism in place for cataloging and cross-agency utilization of tissue 

samples, it would be very difficult to have that kind of collaboration 
230

without the risk of many situations like the Sunderland situation coming 

up. Wouldn’t you agree? 

 DR. INSEL. I agree with what you are saying but again I want to 

clarify. I think you have to separate out issues of data tracking, which in 

some ways are software systems issues that we can do, anyone can do. 

That is different than the issue of oversight and how you make sure that 

people are doing the right thing, and that still-- 

 MS. DEGETTE. Right. It doesn’t sound like we have got either one 

in place though. 

 DR. INSEL. Well, what I am telling you is that we are looking at 

ways of getting the tracking in place but if we simply did that, we 

wouldn’t fix the oversight issue. The oversight issue is the one that 

really needs to be a focus right now. How do we make sure that people 

are doing what they are supposed to do. We come back--I think you 

weren’t in the room yet but--to true north, the central principle, public 

office separated from private gain. 

 MS. DEGETTE. Right. Well, I am with you there. What more do 

you think we can do to make that oversight a reality because the last set 

of hearings we had, and I was there, I was on this subcommittee, it was 2 

years ago and yet here we are again. 

 DR. INSEL. So Mr. Chairman, if I may, we have actually brought a 

little diagram to give you some ideas of how we think about doing this, 

and these have been handed out to you. 

 MS. DEGETTE. Mr. Chairman, I would ask unanimous consent that 

the copies be made a part of the record. 

 MR. WHITFIELD. Without objection. The copies are being passed 

out now. 

 [The information follows:] 
231

 DR. INSEL. I wouldn’t want the subcommittee to think for a moment 

that we don’t have anything in place for oversight. We have a great 

number of ways in which this is done, and what this diagram which you 

will have copies of demonstrates is that there are actually four different 

forms of oversight for anybody who wants to begin analyzing a clinical 

sample. There is the Institutional Review Board that looks at the issues 

of human subjects’ protections. There is a Board of Scientific 

Counselors that looks at scientific quality and whether these are studies 

that should be done anyway. There is the Office of Technology Transfer 

that deals with questions around collaborations. And then the deputy 

ethics counselor, which has a very important role for making sure that 

there is no conflict of interest. Now, we had all of these in place in 2004 

but what we didn’t have then were the arrows. I think if there is a 

vulnerability in the agency, it was that we weren’t well integrated, in 

some ways in the way you are talking about, Ms. DeGette, around trying 

to have a single agency approach to many of these issues and what we 

are building in place now both with electronic systems and with human 

power as well is making sure that there is cross talk across all of these 

different elements of oversight so that whenever someone applies for an 

MTA, there would be an opportunity to know whether it is indeed an 
232

outside agency with the same agent and to make sure that this goes to the 

Institutional Review Board at the same time. 

 MR. WHITFIELD. The lady’s time has expired. At this time I 

recognize Mrs. Blackburn of Tennessee. 

 MRS. BLACKBURN. Thank you, Mr. Chairman. I thank each of you, 

and I am going to stay right there on the same issue where Ms. DeGette 

was, so basically what we have got are three primary groups that are 

doing research. We have the NIH, we have academia, and we have 

private industry, and what we are trying to figure out is how we have 

appropriate oversight and not impede science. What I feel like I am 

hearing from you is well, we have turned a blind eye to what the 

interface would be between those groups and we have kind of swept 

those relationships under the rug, and let relationships occur, let 

payments occur and then until it became an awareness issue, we chose 

not to address it. Because what I am hearing from you now is well, we 

didn’t have a way to inventory samples but now we are looking at the 

fact that we need a comprehensive inventory. We have a brand-new 

policy of going back to the review board and then in February 2005, Dr. 

Zerhouni established a policy on outside consulting. So Dr. Insel, what I 

think I am hearing from you is, you didn’t think you needed the oversight 

until it came to the attention that there was misbehavior and wrongdoing 

and I understand and appreciate your concern for saying that someone 

deserves the due process through the situation and consideration but our 

taxpayers hold us responsible for exercising the oversight in being 

certain that their tax dollars and the research dollars are being spent 

appropriately and properly. So to go back, we have gone a long way 

around the horn with Ms. DeGette’s question and my question, so, very 

quickly, how do we have proper oversight and not impede the scientific 

research? 

 DR. INSEL. Well, I like the way you put your question because that 

really is finding the sweet spot between making sure that we have the 

oversight we need but at the same time not putting in too many speed 

bumps that delay our ability to find a discovery for Alzheimer’s disease 

or autism or another very serious illness, and that is a delicate balance in 

some cases. Some of the things that-- 

 MRS. BLACKBURN. The action item. You know, let us not talk it to 

death. What do you see as the bullet points, the action items? 

 DR. INSEL. So for us the action items are new policies, and let me 

just go through what we have done even in the last few weeks. You 

know about Dr. Zerhouni’s change last year. We put a moratorium on 

the use of stored samples until we can develop a policy that makes sure 

that every stored-- 
233

 MRS. BLACKBURN. Are you slowing down any research by putting 

that moratorium into play? 

 DR. INSEL. We very well may be. We don’t know that yet. We 

won’t know that until we have a full listing of what is there. 

 MRS. BLACKBURN. Okay. 

 DR. INSEL. We are requiring that all collaborations be documented 

with a written agreement so that we have an opportunity to find out what 

is being done, where it is being done, and who is responsible, and those 

things can be reviewed both by, as I showed you with this diagram, by 

four different groups. And in addition to that, we are making sure that 

the people within the intramural program, the scientists are fully 

educated about what it is these new expectations entail. We have had 

two faculty meetings in the last month to go over these issues. Dr. 

Gottesman will talk more about some of the things that are being done 

NIH-wide. 

 MRS. BLACKBURN. So these are all your band-aids? You basically 

have four band-aids that you are putting in place until you establish a 

policy? 

 DR. INSEL. Well, we have a policy but it is not necessarily a true fix. 

 MRS. BLACKBURN. And for how many years has the NIH being 

doing research? 

 DR. INSEL. Clinical research for close to 60 years. 

 MRS. BLACKBURN. For 60 years, so basically you have flown 60 

years without a policy? 

 DR. INSEL. We have a number of policies, but you have to recognize 

that science changes, the needs change-- 

 MRS. BLACKBURN. I recognize that, and I appreciate that, and I have 

great respect for the work that you do and I want to see that work 

continue. In that vein, how many employees does the NIH have in total? 

 DR. INSEL. I think the full number is about 17,000 to 18,000 for all 

of NIH. 

 MRS. BLACKBURN. Seventeen to 18,000, and how many of those are 

researchers? 

 DR. INSEL. It depends on how you define a researcher. I can tell 

you-- 

 MRS. BLACKBURN. How many are working in the area of research? 

 DR. INSEL. Well, I would assume that almost all of them are 

involved in some form or another with the mission of the agency, which 

is research. I can tell you more from my own institute, NIMH, where we 

have 700 employees. We have 55 or 54 tenured or tenure-track scientists 

and we have got another 60 who are staff scientist or staff clinician 

positions, and there are about another 150 to 200 post-doctoral fellows 

and other kinds of trainees. 
234

 MRS. BLACKBURN. Okay. And then your total budget is how much? 

 DR. INSEL. Our budget for the entire institute, NIMH, is roughly 

$1.4 billion, and about 10 percent of that goes to the intramural program, 

which is the subject of this hearing, which is about $159 million in the 

current fiscal year. 

 MRS. BLACKBURN. Okay. Out of that total budget of $1.4 billion 

for NIMH, what percent goes to research? 

 DR. INSEL. There is about 94 percent, I believe, that goes to research 

support and there is another six percent that is used--I think that would 

be right--for research management, which is providing the administrative 

infrastructure for the research enterprise. 

 MRS. BLACKBURN. All right. Great. Now, in your role as the 

director at NIH and NIMH, have you ever performed any outside 

consulting duties? 

 DR. INSEL. No. 

 MRS. BLACKBURN. You have not? Have any of you at the table 

performed outside consulting duties in your roles? You have never had 

outside consulting agreements? Dr. Friedman, have you? No? Okay. 

All right. Going back to Dr. Molchan from yesterday, I found it so 

interesting that she could have put so much work and energy into a 

project and then it comes to a stop, so let us look at these researchers and 

the research projects that you do. You used the term “independent 

thinkers” in talking about your researchers. How do you prioritize your 

projects? Do you let the researchers choose what they want to work on? 

Do you have an agency agenda? Do you all sit down and say we need to 

work on this, that or the other? So how do you mesh those or are they 

just flying interconnectedly and just recently brought together? 

 DR. INSEL. So again, we are focusing on our intramural program, 

this small group, this jewel in the crown that is here in Bethesda which is 

about 10 percent of what our institute is about. In that case, we have a 

relatively small group of senior scientists who we look to help generate 

the most exciting innovative science, high-impact science that they can, 

and they are reviewed every 4 years, and that review is a very rigorous 

one in which we bring in a panel from outside the agency to look at three 

things: how the research is going, is it going in the right directions, are 

they doing the most cutting-edge work, are they innovative; stewardship, 

how well is this person actually using the resources that have been given 

and mentorship, how well are they training the next generation. 

 MRS. BLACKBURN. And how long has that review process been in 

place? 

 DR. INSEL. Oh, it has been going on at least as long as I know about 

the agency, which is over 20 years. 
235

 MRS. BLACKBURN. Okay. Great. And then how often do these 

researchers choose a project and then choose to terminate a project? 

Does that happen very often, and do you have a library of research that 

other researchers can go back to if they are working on some type of 

research and then they find that there are applications for something that 

was not intended and they think, well, this may work. What is your 

library process? 

 DR. INSEL. To answer your first question about how often does 

someone hit a dry hole, it is often, and that is to be expected. The 

intramural program is for high-risk, high-yield science. High risk also 

means that it may often fail, and we actually don’t see that as a problem. 

In terms of having a library of negative results, that library is in 

publications. That is generally the repository of information for our field 

and people look to publications both for discoveries and for discoveries 

that can’t be replicated. 

 MRS. BLACKBURN. Very good. All right. I think that is about it, 

and I have only a couple seconds left so I yield it back. 

 MR. WHITFIELD. Thank you. At this time I recognize Mr. Inslee. 

 MR. INSLEE. Thank you. Dr. Insel, I was looking at this quite 

colorful chart and it sort of circles a little vial here in the middle and I 

guess that vial is probably where they put the answers and it only looks 

half full on this chart, and it sort of I think is a pretty symbolic 

representation. It just seems to me there is some ambiguity in these 

processes that needs to be fixed. That is an observation of somebody just 

new to this issue. But I want to ask you specifically about the situation 

with Dr. Sunderland. I read in the papers that Mr. Robert Muse, Dr. 

Sunderland’s attorney, said his client “didn’t receive a dime for 

providing anything to Pfizer. He received fees for consulting as for 

lectures. These are known to NIH and they were permitted under NIH 

rules.” And I guess the question I have is, in the relevant time period, do 

you have reason to believe that NIH had information regarding the 

specific financial relationship regarding the collaboration and involving 

the use of human tissue samples that were originally with NIH? 

 DR. INSEL. If you could clarify when you say the relevant time 

period. 

 MR. INSLEE. Well, before 2 days ago. How is that? 

 DR. INSEL. I believe some of this information came to the 

investigation that was done starting in 2004 by the Office of 

Management Assessment. 

 MR. INSLEE. So before an investigation started, did NIH have 

information about the specifics of the collaboration that involved 

apparently use of NIH tissue samples? 
236

 DR. INSEL. Absolutely. We had an MTA, a materials transfer 

agreement, between Dr. Sunderland and Pfizer that documented that 

there was a collaboration to send over 250 cerebrospinal fluid samples 

for analysis of proteins potentially relevant to Alzheimer’s disease. 

 MR. INSLEE. So NIH was aware that there was a financial 

remuneration going to be paid to Dr. Sunderland? 

 DR. INSEL. Absolutely not. So again, let me clarify. We have to 

separate here a scientific collaboration which we encourage and which 

we actually want to promote as long as it is done as one’s official duty 

from an outside activity consulting arrangement with the same agency, 

which has never been permitted, and in this case was undisclosed. 

 MR. INSLEE. So I want to make sure I understand. The financial 

remuneration was undisclosed but the transfer of the tissue samples was 

disclosed? 

 DR. INSEL. Exactly. And bottom line, had he come to you or anyone 

else at NIH and said at that time my arrangement is that I will be 

receiving financial remuneration for collaborative services, I will be 

using NIH tissue samples, they will be removed from NIH physical 

custody, is that permissible under our rules, what would have happened? 

 DR. INSEL. There is a way to do this and it is something that is 

called a cooperative research and development agreement. So someone 

could say--a scientist could say I would like to transfer blood samples to 

company X and I want company X to pay my laboratory to support a 

junior investigator. That is actually perfectly permissible and it is also a 

way of dealing with intellectual property. All of that has been worked 

out so there are ways to do this but that is not what we are talking about 

here. 

 MR. INSLEE. Well, in what way is it different? I guess what I am 

saying is, had permission been sought by this particular investigator for 

this relationship, would it have been granted? 

 DR. INSEL. Not in the way that it has been described in the staff 

report. That kind of outside activity, consulting, would not have been 

permitted for someone who had a collaborative arrangement with the 

same agency. What I am telling is that if someone wants to collaborate, 

we try to encourage that. If there is intellectual property at stake, there is 

actually a way to manage that. That is called this cooperative research 

and development agreement. That was not actually in the case in this 

particular example. 

 MR. INSLEE. This may clear to everyone listening to this but I want 

to make sure I understand it as well. In what way would it have not been 

consistent with those rules? That it was going to outside the NIH 

financial structure or was it going to the person who took possession? In 

what way would it violate those rules? 
237

 DR. INSEL. Because what this does is, it violates the fundamental 

principle, which we keep coming back to. It is that overlap between 

public office and private gain, and the way that we would manage that 

generally is with this CRADA mechanism and allow someone to actually 

pursue a collaboration and potentially also seek intellectual property 

protection or patents. The mechanism used here, the materials transfer 

agreement, doesn’t actually permit that and it is not reviewed in the same 

way. There is a very extensive review process for a CRADA that 

ensures that there is no outside activity, that there is no private gain 

involved. That was not the case. This particular case was not reviewed 

in that way. 

 MR. INSLEE. What is the sanction if there is a violation of any of the 

several policies that you have talked about? 

 DR. INSEL. What is the penalty? 

 MR. INSLEE. Yes. 

 DR. INSEL. It is really wide range and it depends on the severity of 

the penalty and it depends on whether--for instance, in a case, and I don’t 

want to go into this particular case because this is already under 

investigation elsewhere--but one could imagine that the central question 

that would be asked is, had someone sought approval, would it have been 

granted, is there actually an inherent conflict of interest here, those kinds 

of issues, and so the sanction, the penalty would range from reprimand to 

suspension to termination, depending on how those particular factors line 

up. 

 MR. INSLEE. Thank you. 

 MR. WHITFIELD. At this time I will recognize the full committee 

Chairman, Mr. Barton. 

 CHAIRMAN BARTON. Thank you, Chairman Whitfield and Mr. 

Stupak, for continuing this hearing from yesterday. 

 My first question, Dr. Insel, what are the inventory control practices 

now in place at NIH for human tissue sample collection, maintenance 

and tracking purposes? 

 DR. INSEL. As I said before you came in, Mr. Chairman, we have no 

central tracking of human tissue samples NIH-wide at this point. 

 CHAIRMAN BARTON. Is there an effort to initiate such a central 

tracking system? 

 DR. INSEL. There certainly is. There has been a lot of discussion 

partly as the result of the work of this subcommittee to figure out how we 

can do this much better, and I can give you a quick rundown of some of 

the things that we are involved with if that would be helpful. 

 CHAIRMAN BARTON. Now, we are preparing an NIH reauthorization 

bill which I hope to have public within the next month if not sooner. Is 

this something that should be a part of that bill? 
238

 DR. INSEL. I think we need to dig it into a bit. When you think 

about how you want to specify--I guess it is a question, if you will, of 

granularity. Do you want to have a tracking system that goes after every 

freezer, every shelf, every sample and every component of every sample? 

I think there has got to be a point at which we think about what the 

details would mean, and as we said earlier in the hearing, finding this 

sweet spot between promoting discovery and rapid advances in science 

but not putting in too many speed bumps for the purpose of oversight. 

We need it, but we need to find a way to do it so that we are still able to 

make the kind of progress we need. 

 CHAIRMAN BARTON. Well, the staff memo that is attached for this 

hearing says the current NIH system for human tissue sample collection 

and maintenance is fairly loose and ad hoc. Is that an accurate 

assessment? 

 DR. INSEL. I think if you take the pejorative term, pejorative 

connotation of ad hoc out, I would say that it is ad hoc in the sense that it 

is delegated to individual scientists who have the greatest investment in 

their own samples. They have collected them, their careers depend upon 

them, and I believe as you heard yesterday from Dr. Molchan, even in 

this case, which has generated so much interest in tissue tracking, you 

have a scientist who apparently had a pretty good handle on exactly 

where every sample was and how to find it and he was able to generate 

13 years after the fact the samples in question so I am not sure that I 

would say that it is loose, but I would say that it has been delegated to 

individual scientists to make sure that they are doing the job the way-- 

 CHAIRMAN BARTON. But you are in agreement that the current 

system can be improved upon? 

 DR. INSEL. I think the current system needs to be improved upon. 

The question is how. We want to make sure that our solution doesn’t 

create new problems, and that is why I don’t want to rush into this. 

 CHAIRMAN BARTON. All right. Well, let us go on to the next 

subject. We have one of your researchers, a Dr. Trey Sunderland. Is he 

still on staff at NIH? 

 DR. INSEL. He is. 

 CHAIRMAN BARTON. Is he on full capability or is he on leave with 

pay or what is his current status? 

 DR. INSEL. He comes to work. He is getting, as far as I know, full 

salary and he stills serves as the chief of the geriatric psychiatry branch. 

 CHAIRMAN BARTON. Okay. So he is still on active duty without 

any-- 

 DR. INSEL. That is correct. 

 CHAIRMAN BARTON. Are you aware that the subcommittee has got 

documents in evidence that leads us to believe that he has been 
239

compensated--I don’t know how to put this--in a fashion that doesn’t 

appear to comport with the regulations in place at NIH? 

 DR. INSEL. I have seen the subcommittee documents that suggest 

that he received outside income for consulting with Pfizer. 

 CHAIRMAN BARTON. Well, we have some evidence that shows 

$285,000 in payments that appear to be inappropriate, another $200,000 

in various expenses that appear to be inappropriate, and over $300,000 in 

lecture fees that may or may not be appropriate. Now, those numbers 

add up to three-quarters of a million dollars. What is the average salary 

of somebody in his position or similar position at NIH right now? 

 DR. INSEL. Well, for someone who is a lab chief, the salaries vary 

between--generally between $150,000 and $200,000. 

 CHAIRMAN BARTON. So three-quarters of a million dollars in 

compensation of a questionable nature should raise some eyebrows. It 

would certainly raise eyebrows if a member of this committee--I think 

our average salary--it is $165,000. If I had outside income of $750,000 

that I didn’t report on my financial disclosure statement and came from 

people who had pending legislation before this committee, I would have 

an ethics investigation by the Minority party and probably a contested 

primary and every newspaper in the country asking for my resignation 

from Congress. 

 Now, I understand that Dr. Zerhouni has changed the ethics 

requirement at NIH and some of what happened with Dr. Sunderland 

predated that, so it could well be possible that some of the things that are 

now unacceptable under the regulations at NIH were acceptable. I 

haven’t seen a timeline so I am not going to say with certainty that all of 

this compensation that I just enumerated will turn out to be unacceptable, 

but I will say with certainty that it seems puzzling to me that he still is in 

his current position with no apparent reaction from the administration at 

NIH. 

 DR. INSEL. Well, Mr. Chairman, if I may, I think it is important to 

realize that there has been an extensive investigation. There has been a 

set of findings. The case has been referred. He is an employee of the 

Commissioned Corps. The NIH itself doesn’t have the authority to either 

hire or fire Dr. Sunderland. This is done through the Commissioned 

Corps. 

 CHAIRMAN BARTON. But do you have the authority to put him on 

leave with pay? You do have the authority to transfer him. 

 DR. INSEL. In fact, my understanding is that his disposition of his--

of where he works and what he does is at this point in the hands of the 

Commissioned Corps, and if I can add-- 
240

 CHAIRMAN BARTON. What would happen if Dr. Sunderland went 

out and robbed a bank and then reported to work? Would he report to 

work with full benefits? 

 DR. INSEL. Let me explain that. Had he been a civil servant and that 

is the case for over 90 percent of the scientists at NIH, this would have 

been resolved months ago and we wouldn’t be having this discussion at 

this point in time. We made a recommendation November 21. We made 

the referral at that point to the Commissioned Corps. It is really out of 

our hands at this point unfortunately, and I also want to add that I think 

that fixing this is not enough. I think you need--the subcommittee needs 

to understand that the NIH intramural program, it is not good enough to 

just be clean. It has to be Camelot. It has to be the place where no one 

will have any question about conflicts of interest. There has to be some 

place in the United States where the public knows that there is no taint, 

that there is no question, that there is no outside investment that is 

involved, that this is being done for the public good. This is the place. 

And for anything to come up that would in any way soil that reputation, 

we need to take care of it and we need to do more than fix it. We need to 

actually become the model for how this research is done. 

 CHAIRMAN BARTON. On a bipartisan basis, subcommittee staff has 

been working on this for at least 6 months and maybe longer, and the 

report that I get is that Dr. Sunderland failed to provide information, 

failed to cooperate. What little information that we have gotten, some of 

it appears to be misleading or intentionally inaccurate, and unless I am 

briefed by you or your staff later today, Dr. Zerhouni’s staff, nobody is 

disputing, that I am aware of, that some of the payments that I just 

enumerated are not facts, that we misinterpreted, that there is a 

misunderstanding. 

 DR. INSEL. So in the-- 

 CHAIRMAN BARTON. And so we have a person who has on the 

surface suffered no repercussion, none, and you talk about a Camelot. 

 DR. INSEL. You can see why I am frustrated. I should add that in the 

past few days I understand that his case has been referred to the Inspector 

General and to the Department of Justice, that that is based not on what 

the original investigation focused on, which was the questions about 

whether there was overlap between official duty and outside activities, 

that is based on some of the new accusations that the subcommittee has 

brought to our attention. 

 CHAIRMAN BARTON. Well, my time is expired. We want NIH to be 

the crown jewel. I would much rather be here hosting a hearing where 

we highlight the breakthroughs on Alzheimer’s research. My mother has 

Alzheimer’s. I would love to be commending Dr. Sunderland and 

yourself and the other doctors for medical research breakthroughs that 
241

make life better and easier. It is no fun to be holding this kind of a 

hearing. 

 DR. INSEL. Amen. 

 CHAIRMAN BARTON. But it is inexcusable that in spite of the public 

changes that have been made at NIH, there really does not appear to be a 

cultural change where the institution and the members of the institution 

condemn the kind of behavior that apparently Dr. Sunderland has 

exhibited. It is really, really disappointing. And with that, Mr. 

Chairman, I yield back 

 MR. WHITFIELD. Mr. Bass. 

 MR. BASS. Thank you, Mr. Chairman, and I am not going to use my 

whole time here and I follow on with what the Chairman has said. This 

is a little bit reminiscent of the controversy that we had back at the 1990s 

at Los Alamos when I was on the Intelligence Committee. It was an 

issue fundamentally of culture and the relationship that the scientific 

community had with the administrative community. Obviously the 

issues there were entirely unrelated to what we are talking about here 

today. I believe that you have addressed the issue of what Dr. 

Sunderland’s status is. Are you aware of the fact that he may not 

actually be--there is a possibility that he may not be at his desk all the 

time, that he has another job somewhere else or he may have a laboratory 

that he goes to somewhere else? Is that--are you aware of that or not? 

 DR. INSEL. I am not aware that he has any other employment. 

 MR. BASS. All told, you have here allegations at least that there is an 

impropriety involving outside activity and consulting with the same 

agent. There are issues of activity that is not allowed. There are 

disclosure issues. There may be patent issues involved. Do you have 

specific recommendations for NIH or NIMH with respect to what new 

policies should be enacted over and above what has been done now that 

would correct this problem and return this agency to what the Chairman 

or you referred to rather as the Camelot of research entities? 

 DR. INSEL. Well, I do have a number of ideas about that, and of 

course, Dr. Zerhouni has spoken to the subcommittee on several 

occasions to explain many of the things that are being done in the ethics 

arena starting with first the prohibition against outside activities with 

either drug companies or pharmaceutical companies, putting in a whole 

new set of safeguards to make sure that we review any outside activity 

request, and also having increased requirements for disclosure. All of 

that was done over the last 18 months. Here we are talking about some 

slightly different issues which have to do not much or not only with 

ethical violations but with questions about how our tissue samples and 

how our clinical samples in general are managed and there I think is part 

of why I put together this chart for you. I wanted you to see that we do 
242

have several independent programs that oversee how clinical samples are 

used. I think the challenge for us going forward is providing the 

appropriate integration of those programs and also the appropriate 

oversight within each one to make sure that people are doing exactly 

what they have been approved to do. 

 MR. BASS. And it is possible that this collaboration and consulting 

may have actually been of significant benefit to the research effort. Is 

that correct or not? Is it possible? I mean, did the work that Pfizer did 

save NIMH a significant amount of time and money or not? 

 DR. INSEL. I think that is in fact the case. My understanding is that 

the collaboration was fundamentally to measure two proteins in spinal 

fluid. The antibody for one of those proteins was a licensed agent that 

wasn’t widely available. It is quite expensive to have those tests done, 

and Pfizer, as I understand it, agreed to do those free of charge at a 

tremendous savings to the agency. 

 MR. BASS. Fair enough. I don’t have any further questions, Mr. 

Chairman. 

 MR. WHITFIELD. Mr. Stearns. 

 MR. STEARNS. Thank you, Mr. Chairman. Dr. Insel, you have been 

at your present position since 2002? 

 DR. INSEL. November 2002. 

 MR. STEARNS. You had mentioned in your conversation with 

members that you can’t manage unless you can measure it, and you went 

on to say that Dr. Sunderland had a great tracking system. I think those 

were your words just 20 minutes ago. 

 DR. INSEL. That is right. 

 MR. STEARNS. In this graph, the committee, trying to identify the 

collected spinal fluids, found that what Dr. Sunderland provided in 2005 

is yellow. Molchan provided 97. This is sort of bluish amber. And this 

is the accounted for samples. Did you know that all these samples are 

unaccounted for? 

 DR. INSEL. Can I ask what you mean by unaccounted for? 

 MR. STEARNS. Spinal fluid for lithium studies. Do you want me to 

show you this graph? 

 DR. INSEL. I haven’t actually seen the graph but the spinal--so if we 

are talking about the study done from 1991 to 1993, we had--there were 

25 subjects who were entered into the study. There were 15 who had 

two lumbar punctures who could have been used for Dr. Molchan’s-- 

 MR. STEARNS. Well, the staff is saying this is unaccounted for if you 

go to that graph. Were you aware that these are unaccounted-for samples 

that we have no measurement of? 

 DR. INSEL. I really--with all due respect, I think-- 

 MR. STEARNS. Do you dispute what the staff’s graph is? 
243

 DR. INSEL. What I would dispute is what is meant by unaccounted. 

Dr. Sunderland has not, as far as I know, given away all of his spinal 

fluid to anyone. There are five -70 freezers-- 

 MR. STEARNS. Let me just finish here. I’ve got a memo here--June 

20, 2005, to you--oh, this is your original message and “Gottesman’s 

office has been collecting rules, regulations, and policies. We need the 

following specific information on GPB protocol: a list of samples that 

went to Pfizer and not a list of names but a list that shows number of 

samples and protocol so we can link consents to samples, copies of 

consents.” It indicated that, you were sort of aware of all these 

unaccounted-for samples. In fact, you were asking for it in this memo. 

Do you want me to show you this memo? 

 DR. INSEL. No, I know the memo that this my-- 

 MR. STEARNS. This is in 2005. Would that be fair-- 

 DR. INSEL. To-- 

 MR. STEARNS. You were asking for the unaccounted samples in 

2005? 

 DR. INSEL. Did I use the word “unaccounted” in the memo? 

 MR. STEARNS. I am told by staff you were looking for the data that 

would help to answer where these unaccountable samples were, so that 

was over a year ago. 

 DR. INSEL. I--the memo that I sent, the e-mail I sent was that I 

wanted to find out what was sent to Pfizer and for the protocol-- 

 MR. STEARNS. Well, Pfizer or someone else, not necessarily just 

Pfizer. 

 DR. INSEL. I am sorry, but in the memo, what I was asking 

specifically was the request about Pfizer. 

 MR. STEARNS. You said you wanted the number of samples and 

protocol. 

 DR. INSEL. I wanted the number of samples that would have been 

sent and the protocols that were involved in those shipments. 

 MR. STEARNS. Are you saying you weren’t aware of that large 

number of unaccounted samples? 

 DR. INSEL. I am saying this to me is a very different topic. You are 

asking--so my understanding is that Dr. Sunderland had something like 

16 protocols in which CSF was collected and many, many samples from 

across those protocols were sent to Pfizer. I wanted to get a listing of 

what was sent and what were the protocols that covered it. 

 MR. STEARNS. Well-- 

 DR. INSEL. This is a question about one particular protocol done 

many, many years earlier that had to do with lithium which I must say is 

one of the smallest-- 

 MR. STEARNS. Are you saying the graph is wrong? Yes or no. 
244

 DR. INSEL. I am--I would dispute the term “unaccounted for 

samples.” 

 MR. STEARNS. Okay. 

 DR. INSEL. Because it makes it sound as if they are lost. They are 

not lost. 

 MR. STEARNS. Well, do you know what happened to them? 

 DR. INSEL. I can tell you that--you know, I-- 

 MR. STEARNS. Can you tell me today what happened to all these 

samples? 

 DR. INSEL. I can tell you that Dr. Sunderland has a large number of 

CSF samples that are still stored at the NIH or through one of our 

contractors. 

 MR. STEARNS. In other words, today you can go back and identify 

all these samples today if we went out to NIH this morning? 

 DR. INSEL. This is really the core of what we have been talking 

about for the last hour. I specifically don’t have an accounting for every 

sample. I have an accounting for the protocols. I have an accounting for 

the-- 

 MR. STEARNS. But the people who work for you have that, is what 

you are saying? 

 DR. INSEL. Dr. Sunderland would have--I think could account for 

everything out there. 

 MR. STEARNS. But you said you can’t manage unless you measure, 

but here it has been a year and you can’t measure where these 

unaccounted samples are, so how can you manage it? 

 DR. INSEL. I am disputing your use of the word “unaccounted for.” 

What I am telling you is that there are samples that remain under Dr. 

Sunderland’s supervision. He is expected to be accountable for them. 

 MR. STEARNS. But he has not been accountable to you at this point? 

 DR. INSEL. I have not specifically asked the question of him, where 

are the five missing tubes of the many tens of thousands that you have 

from 1991. 

 MR. STEARNS. Let me go to the financial disclosure to the IRB. In 

part of that review process, Dr. Sunderland filed an exhibit which is 24, 

and the question which he checked off “no” said, “Have any 

investigators developed an equity or consultant relationship with a nonNIH source related to this protocol which might be considered a conflict 

of interest?” He checked off “no” and Dr. Rosenstein, your signature I 

guess is on here too. Do you think in light of what has happened here 

that Dr. Sunderland should have checked off “no.” Is that in your mind 

satisfactory that he checked off “no” on this form? 

 DR. ROSENSTEIN. This is a question to me? 

 MR. STEARNS. Yes. 
245

 DR. ROSENSTEIN. I to this day don’t know what the precise details 

of the relationship between Dr. Sunderland and Pfizer Pharmaceutical is 

so I can’t answer that question definitively. I can say that if an 

investigator has a consultative relationship that is related to the research, 

then that should be checked off “yes.” 

 MR. STEARNS. Well, let us just go back. Let us say you knew the 

facts today of his relationship with Pfizer and you had to put your 

signature down here. Would you have questioned Dr. Sunderland 

knowing what you know today about his relationship with Pfizer? 

 DR. ROSENSTEIN. Yes, I would have. 

 MR. STEARNS. And what would you have said to him? 

 DR. ROSENSTEIN. I would have asked for a description of the nature 

of the collaboration and would have brought that back to the full IRB. 

 MR. STEARNS. Would you allow him to vote to check off “no” on 

this form based upon what you know today? 

 DR. ROSENSTEIN. As you have heard, the samples that were sent to 

Pfizer were drawn from several different protocols. 

 MR. STEARNS. No, no, I mean just yes or no, if you knew back then 

what you know today about his relationship with Pfizer, would you have 

accepted him checking off “no” on this form? 

 DR. ROSENSTEIN. I would have raised the question at the IRB 

meeting, to ask for an explanation. 

 MR. STEARNS. And you would say Dr. Sunderland, is it possible that 

yes, you do have a disclosure and you should attach or append to this 

document your disclosure as what the form is requesting? 

 DR. ROSENSTEIN. Yes. 

 MR. STEARNS. So you would have done that knowing what you 

know today? 

 DR. ROSENSTEIN. Yes. 

 MR. STEARNS. So Dr. Insel, who is this Commissioned Corps? You 

are pretty much saying you can’t do anything with Dr. Sunderland. You 

know that he is going to testify and you probably know he is probably 

going to take the Fifth. That is probably almost a 99 percent conclusion. 

I mean, I read his lawyer’s comment here. He wouldn’t come here 

unless the committee voted and he wants all his rights which I respect 

and he should have his rights. But I think it is pretty much a foregone 

conclusion he is going to take the Fifth, and with that in mind, you are 

saying you have no responsibility for his supervision or his employment 

or anything, that he has to report to this Commissioned Corps. Is that 

what you are saying today? 

 DR. INSEL. No. I am his supervisor because-- 

 MR. STEARNS. Are you his supervisor? 
246

 DR. INSEL. As the Scientific Director, and I am in an acting capacity 

in that job for the next few weeks-- 

 MR. STEARNS. Because you told Chairman Barton that you could 

not fire him, you could not do anything. 

 DR. INSEL. That is right. 

 MR. STEARNS. Now you are saying you are his supervisor? 

 DR. INSEL. And I have been--both things are true, so he is a member 

of the Commissioned Corps which means that he is essentially detailed 

to the NIH and hiring, firing, and promotion are done through the Corps, 

but the day-to-day supervision is done at the NIH. 

 MR. STEARNS. Like in a corporation, the hiring and firing is done 

through the personnel agency but the CEO can fire anybody he wants, 

and I assume that is what you are so-- 

 DR. INSEL. Are you making a recommendation-- 

 MR. STEARNS. The Commissioned Corps hires him but certainly if 

you felt his behavior was abhorrent, couldn’t you make a 

recommendation that he be put on administrative leave? 

 DR. INSEL. I have done this. I have--there was an investigation and 

there was a recommendation that-- 

 MR. STEARNS. What was your recommendation? 

 DR. INSEL. The recommendation to the Commissioned Corps was 

that we--based on the findings from the Office of Management 

Assessment, I was deeply disappointed and it appears to be--I think I said 

the violations were severe enough to merit termination were he in the 

civil service. I can’t tell them what to do but I can tell them what we 

would do if he were-- 

 MR. STEARNS. So you recommended to the Commissioned Corps 

that he be dismissed? 

 DR. INSEL. Yes. 

 MR. STEARNS. Okay. Thank you, Mr. Chairman. 

 MR. WHITFIELD. Mr. Ferguson. 

 MR. FERGUSON. Thank you, Mr. Chairman, and I appreciate your 

having this hearing. 

 I have some questions for Dr. Friedman actually. So Dr. Insel, you 

can just catch your breath for a few minutes. You have been getting a lot 

of questions this morning. Dr. Friedman, I didn’t want you to feel that 

you were wasting your time this morning sitting here. But I want to 

further examine this relationship between Sunderland and Pfizer, and I 

read your testimony. You seem to know a little bit about that. So let us 

back up for a second. To your knowledge, did Pfizer contribute 

resources to the screening effort involved in these NIH samples? 
247

 DR. FRIEDMAN. They contributed a tremendous amount. There 

were at least half a dozen people that worked for years as well as 

enabling technology to be developed. 

 MR. FERGUSON. What kind of commercial products came from that? 

 DR. FRIEDMAN. No commercial products. 

 MR. FERGUSON. Zero? 

 DR. FRIEDMAN. To the best of my knowledge. 

 MR. FERGUSON. Could this type of research, this biomarker research 

that you have described, is it possible that this research would contribute 

to development of treatments for Alzheimer’s? 

 DR. FRIEDMAN. It is viewed as being critical for development for 

treatments. 

 MR. FERGUSON. What happens to this kind of research? It gets 

published, what happens when someone conducts significant research 

that could have a real impact on-- 

 DR. FRIEDMAN. That is above and beyond what I know about this 

particular collaboration. 

 MR. FERGUSON. In general. 

 DR. FRIEDMAN. In general, there is a point where it gets published 

and that usually follows patent applications but it’s always dependent on 

the distribution of the intellectual property which is usually decided in 

advance. That is my basic understanding of it. 

 MR. FERGUSON. Who reads the publications? 

 DR. FRIEDMAN. Dr. Insel would be a good example of who reads the 

publications. Everyone in the scientific community does. It is open for 

input and that is one of the cornerstones of basic science. 

 MR. FERGUSON. So anybody in the health community could benefit 

from this research of it is published and-- 

 DR. FRIEDMAN. As a matter of fact, I think that they could even 

benefit from the patent application information as well. There is a 

tremendous amount of information that is in the public domain and has 

been for years. 

 MR. FERGUSON. Okay. Now, we know that the rules for these 

consulting arrangements have changed since this particular instance that 

we are looking at today, that Dr. Zerhouni has told us about that, that the 

rules at NIH have changed regarding what is proper since this 

consultative relationship that Dr. Sunderland had with Pfizer, correct? 

 DR. FRIEDMAN. That is what I am hearing. 

 MR. FERGUSON. How would you characterize this relationship 

between Dr. Sunderland and Pfizer? 

 DR. FRIEDMAN. With regard to-- 

 MR. FERGUSON. The activities, the consulting relationship that Dr. 

Sunderland had with Pfizer. 
248

 DR. FRIEDMAN. I really know very little-- 

 MR. FERGUSON. You played a role in the initial-- 

 DR. FRIEDMAN. What little I know about the consulting arrangement 

I have learned in the past few months being a part of this process. I am 

really not in a position to comment. I only know fragmentary 

information. I mean, if you want me to comment on information that is 

part of the committee report, it would be a totally uniformed-- 

 MR. FERGUSON. Yes. 

 DR. FRIEDMAN. I will make one comment. From my experience of 

being part of several collaborations in different drug companies, direct 

compensation of $25,000 a year for the level of activity that Dr. 

Sunderland contributed to this project is modest at best. 

 MR. FERGUSON. How do these situations police themselves? Whose 

responsibility is it to police these-- 

 DR. FRIEDMAN. To police them? 

 MR. FERGUSON. Yes. 

 DR. FRIEDMAN. From the point of view of a drug company? 

 MR. FERGUSON. Sure, or the point of view of any of us looking at 

these situations. 

 DR. FRIEDMAN. I wouldn’t have any clue. 

 MR. FERGUSON. Well, would it be fair to say that a company in one 

of these situations is relying on the consultant to make a determination 

whether the relationship is appropriate or not? 

 DR. FRIEDMAN. It would be a guess if I answered that because I 

really have no knowledge of that. 

 MR. FERGUSON. What is your guess? 

 DR. FRIEDMAN. It is a fair assumption. 

 MR. FERGUSON. Okay. That is all I have. Thank you very much. I 

yield back. 

 MR. BURGESS. Will the gentleman yield for just a moment? 

 MR. FERGUSON. I would yield to Dr. Burgess. 

 MR. BURGESS. Dr. Friedman, you testified that the markers were in 

fact critical, the research into the biological markers in Alzheimer’s was 

a critical part of that research? 

 DR. FRIEDMAN. I commented that the identification of these markers 

is critical to the development of Alzheimer’s therapeutics from the point 

of view of large drug companies. That is part of, as you are well aware, 

the necessity of tracking any kind of efficacious response to a therapeutic 

over a reasonable period of time. 

 MR. BURGESS. And yesterday we heard testimony that the samples 

themselves were by virtue of having all of the genetic and clinical data 

on the people from whom they were recovered, that the samples 

themselves were extremely valuable. I guess what is troubling me is, in 
249

1995, 1996 and 1997, you closed the study on an aspect of Alzheimer’s 

that is critical to understand on samples that were widely acknowledged 

to be very valuable, and as a taxpayer and perhaps one day a consumer of 

whatever might be developed from this research at NIH, I am more 

troubled by that than anything else I have heard this morning, that we 

have a valuable field of study that we are basically just capping and 

walking away from and leaving in the refrigerator. I think--part of me 

says we should be grateful that someone picked this up and ran with it. 

 MR. FERGUSON. Are you looking for a response on that because I 

would like to reclaim my time? 

 MR. BURGESS. I was looking for a response from anyone who feels 

moved to respond to that. 

 DR. FRIEDMAN. I think Dr. Insel made the point which I will 

reiterate, good science never disappears. It is picked back up again by 

other investigators either in the intramural programs or extramural 

programs. People at drug companies-- 

 MR. BURGESS. Since he is going to reclaim his time, you came 

perilously close to just disappearing back in the corner of that 

refrigerator when the study was capped in 1995 or 1996 before someone 

continued some type of research with those samples on biomarkers 

which we have admitted are critical to the understanding of Alzheimer’s 

disease, on study samples that were very valuable because genetic 

contact and makeup of the study participants was known. I am just 

troubled that that might have not happened. 

 MR. FERGUSON. Now I am really going to reclaim my time. Just in 

closing, Mr. Chairman, the point I guess I am trying to draw out and 

confirm is that there can be great value, it seems to me, there can be great 

value to these collaborative arrangements and that is what it sounds like 

some of you have said this morning as well. There can be tremendous 

value to these collaborative arrangements but of course, the ends don’t 

justify the means if they are not being done in a proper way, if they are 

not being disclosed in a proper way. To this point it seems like the 

policing for these arrangements has largely fallen to the researcher, the 

investigator themselves. That is probably why it is a good idea that Dr. 

Zerhouni is laying out some new guidelines. But we have to--and we all 

want the Camelot that you had described before, but it is going to be very 

important for us as we move forward, all of us together, to make sure that 

we don’t lose the value of these collaborative efforts because of the 

enormous importance of the work that NIH is doing for the health of the 

Nation, and we just have to make sure that we are doing it in the right 

way and we have to make sure that we don’t have this ends-justify-themeans mentality. I think maybe that is how I would sum up my feeling 
250

on this, and I would suspect that may be true for others on the panel as 

well. Thank you, Mr. Chairman. 

 MR. WHITFIELD. Thank you. Just one other question, then we will 

get the second panel. Before I ask that question, did you have a 

unanimous-consent request, Ms. DeGette? 

 MS. DEGETTE. Yes, Mr. Chairman. I am sorry I missed the opening 

statements yesterday and I would ask unanimous consent that I be 

allowed to submit mine for the record. I would also ask unanimous 

consent that the record be kept open for this panel and the next panel and 

the panel yesterday for the requisite number of days for additional 

questions if members have-- 

 MR. WHITFIELD. Without objection, so ordered. Dr. Friedman, you 

had testified that when you initiated this discussion, the initial discussion 

with Dr. Sunderland, that you were primarily focused on the transfer of 

the material and so forth and you were certainly not focused on meeting 

any ethical requirements at NIH. Is that true? 

 DR. FRIEDMAN. Well, it certainly wasn’t my responsibility. 

 MR. WHITFIELD. Right, not your responsibility. 

 DR. FRIEDMAN. But it also wasn’t true that I was focused on the 

transfer of the samples. I was focused on setting up, being participatory 

in setting up a collaboration. 

 MR. WHITFIELD. Collaboration. Okay. Now, I just want to read one 

excerpt to you. On Exhibit 41, if you would turn to that, this is a letter 

from Mr. Robert Muse, who I assume is the attorney for Dr. Sunderland, 

and in that exhibit it is a letter from Dr. Muse to Holly Beckerman-Jaffe, 

who is the Director of the NIH ethics office, and the reason I want to 

bring your attention to page 9 is that in this letter, Mr. Muse refers to 

you, and he said at the time of his inquiry, and I am assuming as you are 

exploring this coloration opportunity, Dr. Friedman was not aware that 

Dr. Sunderland had any prior association with Pfizer and that Dr. 

Sunderland promptly notified Dr. Friedman of this and stated that he 

would not be able to undertake any actions with regard to the 

collaboration until such activity was cleared and approved by NIH. Do 

you remember having that conversation with Mr. Muse? 

 DR. FRIEDMAN. I remember the conversation with Mr. Muse. I 

don’t remember the exact details of that exchange but at no time was I 

involved in asking about what Dr. Sunderland’s responsibilities were. 

That was his responsibility. Mine was to set up a collaboration and-- 

 MR. WHITFIELD. But Dr. Sunderland did notify you that he would 

not be able to undertake any action with regard to the collaboration until 

such activity was cleared and approved by NIH? 
251

 DR. FRIEDMAN. What I recall is that Dr. Sunderland informed me 

that he needed to take care of these issues on his own before he could 

proceed. 

 MR. WHITFIELD. And then he went on to say in turn Dr. Friedman’s 

goal was to make sure that the business, medical, and administrative 

people at NIH were fully informed. 

 DR. FRIEDMAN. That is certainly not true. In no way did I have any 

business responsibilities nor would Pfizer have given me those in any 

way. 

 MR. WHITFIELD. Okay. And as a matter of fact, Dr. Insel, I think 

you had previously stated that the policy even at that time was that if you 

were in collaboration with an outside entity and you had a consulting 

agreement with that entity, that that was not proper. Is that correct? 

 DR. INSEL. That is correct. 

 MR. WHITFIELD. At this time I would like to thank you all very 

much for your testimony and for being here today. I think this has been 

quite useful as NIH looks forward, moves forward to deal with these 

complicated issues and we want to thank you for the great work that you 

do at NIH and we look forward to continuing working with you as we 

make an effort to make sure it is a Camelot type of agency. Thank you 

very much. At this time I would like to call up the second panel, and on 

the second panel we have Dr. Trey Sunderland and Mrs. Karen Putnam, 

and if you all would please come forward and sit at the witness table, we 

would appreciate that. Dr. Trey Sunderland is the Chief of the Geriatric 

psychiatric branch at the National Institute of Mental Health, and Karen 

Putnam worked for Dr. Sunderland and is a former employee of the 

National Institute of Mental Health. They are here with us today 

pursuant to a subpoena. On May 24, 2006, the subcommittee invited 

these two individuals to voluntarily testify at this hearing but they 

declined. On June 3, 2006, Chairman Barton authorized subpoenas to be 

issued to compel their appearance, which were subsequently served. My 

understanding is that these witnesses will rely on their Constitutional 

right not to testify at today’s hearing. I believe that this privilege which 

is the only basis upon which a witness may refuse to cooperate with an 

inquiry by the House should be personally exercised before the Members 

as we have done in the past. That is why we have insisted on the 

appearance of Dr. Sunderland and Mrs. Putnam today. Given the 

importance of their testimony to this subcommittee’s fact-finding 

processes, I would hope that these individuals might reconsider their 

decision to invoke this Fifth Amendment right and cooperate with the 

subcommittee on this critically important investigation. Dr. Sunderland 

and Mrs. Putnam, you are aware that this subcommittee is holding an 

investigative hearing and in doing so it is the practice of the 
252

subcommittee to take testimony under oath. Do any of you have any 

objection to testifying under oath today? Okay. As you know, under the 

rules of the House and the rules of the committee, you are entitled to 

have legal counsel. Do either of you have legal counsel with you today? 

 MS. PUTNAM. Yes, sir. 

 MR. WHITFIELD. And would you give the name of your legal 

counsel, please? 

 MR. SHURGLER. Your Honor, David Shurgler. 

 MR. WHITFIELD. David Shurgler. 

 MR. SHURGLER. I am licensed to practice in Washington, D.C. 

 MR. WHITFIELD. Thank you. 

 DR. SUNDERLAND. Robert Muse is my attorney. 

 MR. WHITFIELD. Robert Muse. Okay. 

 [Witnesses sworn] 

 MR. WHITFIELD. Thank you very much. At this time both of you 

are under oath, and I would ask either one at this time, do you have any 

opening statement that you would like to make, Dr. Sunderland? 

 DR. SUNDERLAND. No, sir. 

 MR. WHITFIELD. Dr. Putnam? Well, in that case, I would like to ask 

a question. I would recognize myself. Dr. Sunderland, according to 

records from Pfizer, the names and other privacy information of about 

120 people, patients and volunteers who provided spinal fluid in National 

Institute of Mental Health studies, were inadvertently disclosed in 1999 

shipments by your branch to Pfizer as part of one of the biomarker 

projects. Now, Dr. Sunderland, did you know about this disclosure and 

why this occurred? 

 DR. SUNDERLAND. Chairman, as you know, you have had 

correspondence from my attorney, Mr. Muse, on several issues and I 

respectfully decline to answer these questions or any further questions 

based on my Constitutional right. 

 MR. WHITFIELD. So you are refusing to answer the question on the 

basis of your Fifth Amendment rights, and is it your intent to invoke your 

Fifth Amendment rights in response to any other questions we may ask 

you today? 

 DR. SUNDERLAND. It is with great regret that I say yes to that 

question. 

 MR. WHITFIELD. Then you are excused from the witness table at this 

time but I advise that you remain subject to the process of the committee 

and that if the committee’s need is such, then we may recall you. 

 DR. SUNDERLAND. Yes, sir. Thank you. 

 MR. WHITFIELD. Dr. Putnam, my next question for you is this. Mrs. 

Putnam, according to NIH records involving you, there were 2,132 vials 

of spinal fluid shipped to Pfizer in connection with a known biomarker 
253

project representing samples from 538 subjects and about 14 different 

protocols but there were about 1,100 vials shipped in connection with the 

unknown biomarkers or discovery research project. Do you know if 

there is data showing how many subjects are represented in those 

samples and from what protocol numbers? 

 MS. PUTNAM. Upon the advice of my attorney, I will assert my Fifth 

Amendment privileges and respectfully decline to answer. 

 MR. WHITFIELD. So Ms. Putnam, you are refusing to answer the 

question on the basis of the protections afforded to you under the Fifth 

Amendment of the U.S. Constitution? 

 MS. PUTNAM. Yes. 

 MR. WHITFIELD. And you would invoke that Fifth Amendment right 

on any additional questions that we may ask you today? 

 MS. PUTNAM. Yes, sir. 

 MR. WHITFIELD. Then you also are excused from the witness table 

at this time but I would advise you that you remain subject to the process 

of the committee and that if the committee’s need is such, we may recall 

you at some future time. Thank you. At this time I would like to call up 

the single witness in the third panel, and that is Dr. Michael Gottesman, 

who is the Deputy Director for Intramural Research at the National 

Institute of Health. Dr. Gottesman, thank you very much for being with 

us today. We appreciate your time. We look forward to your testimony. 

As you know, this is an investigating oversight committee hearing and it 

is our process to take testimony under oath. Do you have any objection 

to testifying under oath today? 

 DR. GOTTESMAN. No, I do not. 

 MR. WHITFIELD. And do you have legal counsel with you today? 

 DR. GOTTESMAN. No, I do not. 

 [Witness sworn] 

 MR. WHITFIELD. You are now under oath, and we recognize you for 

your 5 minute opening statement. 

STATEMENT OF MICHAEL M. GOTTESMAN, M.D., DEPUTY 

DIRECTOR FOR INTRAMURAL RESEARCH, NATIONAL 

INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

 DR. GOTTESMAN. Thank you, Mr. Chairman, Mr. Stupak and 

members of the subcommittee. 

 I am Dr. Michael Gottesman, the Deputy Director for Intramural 

Research at the National Institutes of Health, an agency with the U.S. 

Department of Health and Human Services. I am responsible for 

oversight and coordination of intramural research, training, and 
254

technology transfer activities conducted within the laboratories of the 22 

intramural research programs of the NIH. So in that sense, I am that 

person who oversees both the research and the policies that keep NIH 

researchers out of trouble. 

 The intramural program represents about 10 percent of the total NIH 

budget, or $2.8 billion in fiscal year 2006. Our 6,000 intramural 

scientists work in an environment where creativity is encouraged and 

cutting-edge research is the norm. Discoveries such as the first effective 

chemotherapy for childhood leukemia and Hodgkin’s disease and the use 

of AZT to treat AIDS were developed in the clinical center at the NIH. 

 The NIH intramural research program could not succeed nor could 

any scientific endeavor without collaborative interactions between our 

scientists and scientific investigators in academic research institutions 

and in private industry. Such collaborations are encouraged as you have 

heard. Without them, the pathway to discovery would likely be slowed 

by innumerable obstacles and many of our greatest research 

achievements might not have occurred. 

 Of course, policies intended to facilitate collaborations between 

Federal and private-sector researchers must be firmly grounded in ethical 

principles. The NIH leadership was reminded of the importance of this 

principle 2 years ago by this subcommittee, and in your 

recommendations, we realize that there were many areas in which we 

could improve our oversight. Your recommendations prompted NIH and 

the Department of Health and Human Services to revisit and dramatically 

strengthen ethics regulations, as you know, in 2005. New department 

regulations addressed vulnerabilities of the NIH ethics system by 

completely banning all personal or outside consulting by NIH scientists 

with pharmaceutical and biotechnology companies. Private outside 

consulting on subjects that are the same or similar to an employee’s 

official duties has always been prohibited, as you have heard, even under 

previous regulations. The events under consideration at today’s hearing 

occurred before these new regulations were issued, the ones absolutely 

banning consulting arrangements. The subcommittee has understandable 

concerns about the transfer of human biological samples from NIH to the 

private sector in connection with the consulting arrangement. NIH 

shares these concerns. 

 First and foremost, we want to know if important biological samples 

were transmitted without adequate controls and if human subject 

protection requirements were met. Second, we want to be sure that our 

internal controls on biological samples are consistent with all 

requirements including the regulation governing outside or personal 

activities. 
255

 Regardless of the outcome of the multiple reviews concerning this 

matter, I would like to be perfectly clear about NIH’s position. Any 

attempt to illegally profit from official research activities, especially 

where human biological materials are involved, is totally unacceptable. 

Engaging in such an activity is a violation of NIH core ethical principles 

past and present. We cannot tolerate such behavior since it undermines 

the credibility of NIH as an unbiased source of scientific information. I 

am told that the material in question, spinal fluid taken from Alzheimer’s 

disease patients, was provided by an NIH intramural scientist to a 

pharmaceutical company. This transfer of human tissue samples has 

raised numerous issues and concerns including the adequate protection of 

the rights of individuals who participate in clinical trials, alleged conflict 

of interest, and intellectual-property issues. These areas of oversight 

involve complex regulations and interactions that need to be clarified, 

and I think Dr. Insel’s chart was just the beginning of the complexity of 

the issue. 

 What can we do to assure that problems such as this do not recur? In 

addition to the reforms implemented in our ethics program, we are 

enhancing policies pertaining to the handling of human tissue samples 

and related intellectual property. While sharing such materials facilitates 

and accelerates the scientific process, it is also clear that additional 

protections must be in place when scientists share tissue samples 

including blood, serum or, in this case, cerebrospinal spinal fluid. 

Accordingly, after reviewing our policies and procedures regarding the 

transfer of such materials, we determined that further clarification is 

necessary and we are taking the following steps. 

 Number one, NIH will provide guidance to investigators on the 

different mechanisms including MTAs, letters of collaboration, and 

cooperative research and development agreements available for entering 

into collaborations and transferring materials outside of the NIH, and we 

will require that all transfers of samples derived from human subjects 

must use a written mechanism so there will be no transfer without a 

written mechanism. NIH will clarify that in cases involving the transfer 

of material derived from human subjects, all such written agreements 

must be accompanied by more-rigorous checks and balances including 

the review and approval by senior leadership at the relevant institute, so 

an investigator on his own cannot arrange to transfer these samples. 

 NIH has initiated a comprehensive review of policies across NIH 

involving MTAs to determine if additional requirements are necessary in 

the case of MTAs that do not involve the transfer of material derived 

from human participants. I just want to point out that most of our 

transfers are of laboratory-derived research tools, pieces of DNA or cell 
256

lines or antibodies, things like that, that don’t directly affect human 

subjects or clinical research. 

 NIH has also reviewed its policies governing the use of stored human 

tissue samples. Stored human tissue samples if identifiable by codes or 

other identifiers are considered human subjects under applicable Federal 

regulations. Research uses of previously collected and stored human 

samples when intramural research program investigators can personally 

identify the sources must be prospectively reviewed and approved by an 

institution review board. This is not negotiable. IRBs are charged by 

Federal regulation 45 CFR part 46 with reviewing research protocols to 

protect the rights and safeguard the welfare of research participants. 

When reviewing a proposed new research use of stored samples, an IRB 

will consider the original research use and carefully consider the 

informed-consent document in order to determine if the new use is 

consistent with the original protocol. We believe the process for 

reviewing uses of stored samples must be clear and rigorous. In order to 

assure that all NIH intramural research program researchers understand 

the requirements for the research use of stored samples, the following 

steps will be or have been taken. 

 A memorandum has been sent to all intramural clinical researchers, 

clinical directors, and scientific directors clarifying the oversight 

requirements for the collection and research use of human samples, data 

and specimens. The clinical center’s Medical Executive Committee, 

which consists of the clinical directors and some other leading scientists 

in all the institutes, implemented procedures to assure that all clinical 

center protocols receive continuing NIH IRB review and approval as 

long as research analyses using coded samples continues. So if a 

protocol is closed but the samples are still valuable, in order to use those 

samples you need continuing review and approval by an IRB. 

 NIH will modify its standard MTA form to include language 

indicating that the transfer of either coded or identifiable samples has 

been reviewed by an IRB or exempt from IRB review pursuant to 45 

CFR 46. All research protocols in which intramural researchers intend to 

collect and store human samples, specimens, or data must include a 

detailed description of the intended use of the samples including any 

proposed future use, even after termination of the protocol. Consent 

documents must include relevant language. While we cannot anticipate 

all prospective uses, we want to ensure that research participants have as 

much information as possible on how their own material will be 

maintained and used. 

 While these new rules will establish conditions to prevent the 

recurrence of the problems we have heard about today, in order to be 

fully successful we must be sure that our staff is fully educated about 
257

these rules, that they have the administrative support needed to keep up 

with the additional paperwork, and we have heard about this issue of 

overloading people with bureaucratic obstacles and delaying research. 

This can be addressed with administrative support and these people can 

also provide expert advice because these are complex regulations. And if 

the rules are knowingly violated, there will have to be consequences. 

 Science is an ongoing process that requires constant review and 

adaptation. The same is true for NIH’s programs that manage the 

research enterprise. Many of our adaptations result from internal review. 

Some ensue from external oversight such as the work of this 

subcommittee. In either case, NIH leadership understands we must be 

responsive. 

 Thank you for this opportunity, Mr. Chairman. I would be pleased to 

answer questions. 

 [The prepared statement of Michael M. Gottesman, M.D. follows:] 

PREPARED STATEMENT OF MICHAEL M. GOTTESMAN, M.D., DEPUTY DIRECTOR FOR 

INTRAMURAL RESEARCH, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES

Good morning Mr. Chairman, Mr. Stupak, and Members of the Subcommittee. I am 

Dr. Michael Gottesman, the Deputy Director for Intramural Research at the National 

Institutes of Health (NIH), an agency within the U.S. Department of Health and Human 

Services (HHS). I am responsible for oversight and coordination of intramural research, 

training, and technology transfer activities conducted within the laboratories of the 22 

intramural programs of the NIH. The intramural program represents about 10 percent of 

the total NIH budget, or $2.8 billion in Fiscal Year 2006. Our 6000 intramural scientists 

work in an environment where creativity is encouraged and cutting edge research is the 

norm. 

The intramural research program provides unique opportunities and resources to 

encourage important high-risk, high impact scientific inquiries that may be difficult to 

pursue in the private sector or academia. Intramural laboratories are regularly subjected 

to rigorous outside reviews. 

 The NIH Clinical Center is the focal point of the intramural enterprise, where 

laboratory scientists and clinicians work in close physical and intellectual proximity, 

providing a unique cauldron for translational and clinical research, with the cost of 

patient participation covered by the NIH budget. The first chemotherapeutic cures for 

childhood leukemia and Hodgkin’s disease, and the first use of AZT to treat AIDS, 

resulted from research done at the Clinical Center, the largest research hospital in the 

country. Of the 19 scientists with medical degrees who have won Nobel Prizes in 

Medicine in the past 20 years, nine were trained in the intramural program at NIH. 

The NIH intramural research program could not succeed – nor could any scientific 

endeavor – without collaborative interactions between our scientists and investigators in 

academic research institutions and private industry in the course of their official work. 

Such collaborations are encouraged. Without them, the pathway to discovery would 

likely be slowed by innumerable obstacles and many of our greatest research 

achievements might not have occurred. 

Of course, policies intended to facilitate collaborations between federal and private 

sector researchers must be firmly grounded in ethical principles. The NIH’s leadership 

was reminded of the importance of this requirement two years ago by this 
258

Subcommittee’s investigation of consulting arrangements between intramural scientists 

and companies in the pharmaceutical and biotechnology industries. Your oversight 

review prompted NIH and HHS to revisit and dramatically strengthen ethics regulations 

in 2005. 

New HHS regulations addressed vulnerabilities in the NIH’s ethics system by 

completely banning all personal or outside consulting by NIH scientists with 

pharmaceutical and biotechnology companies. Private outside consulting on subjects that 

are the same as or similar to an employee’s official duties has always been prohibited, 

even under previous regulations. The events under consideration at today’s hearing 

occurred before these new regulations were issued. It is a sensitive matter that is still the 

subject of ongoing review. 

The events are connected to research on Alzheimer’s disease, specifically attempts 

to identify biomarkers that identify the early presence of the disease. This research is one 

of the most important areas of investigation regarding Alzheimer’s disease and should be 

pursued with vigor. But the quest for biomarkers by NIH must be conducted according to 

Federal rules pertaining to human subjects protection, intellectual property, and conflicts 

of interest. 

As I understand it, the Subcommittee has specific concerns about the transfer of 

human biological samples from NIH to the private sector in connection with a consulting 

arrangement. NIH shares these concerns. 

First and foremost, we want to know if important biological samples were 

transmitted without adequate controls and if human subject protection requirements were 

met. 

Second, we want to be sure that our internal controls on biological samples support 

the application and enforcement of all requirements, including the regulation governing 

outside or personal activities. 

Regardless of the outcome of the multiple reviews concerning this matter, I want to 

be perfectly clear about NIH’s position. Any attempt to illegally profit from official 

research activities, especially where human biological samples are involved, is totally 

unacceptable. Engaging in such an activity is a violation of NIH’s core ethical principles, 

past and present. We can not tolerate such behavior. 

I am told that the material in question – spinal fluid taken from Alzheimer’s disease 

patients – was provided by a NIH intramural scientist to a pharmaceutical company. 

This transfer of human tissue samples has raised numerous issues and concerns, including 

the adequate protection of the rights of individuals who participate in clinical trials, 

alleged conflict of interest, and intellectual property issues. These areas of oversight 

involve complex regulations and interactions that need to be clarified. 

With this principle in mind, on August 25, 2005, HHS, with the concurrence of the Office 

of Government Ethics, published a final rule governing standards of ethical conduct for 

NIH employees. The new regulation contains the following additional provisions: 

• All NIH employees are now prohibited from engaging in outside employment with 

pharmaceutical companies and biotechnology companies. 

• The extent to which the most senior NIH employees may hold certain types of stock 

and other financial interests is severely limited. 

• The number of employees required to disclose financial interests is significantly 

expanded. 

In addition to the reforms implemented in our ethics program, we are enhancing 

policies pertaining to the handling of human tissue samples and related intellectual 

property. While sharing such materials facilitates and accelerates the scientific process, 

it is also clear that additional protections must be in place when scientists share human 

tissue samples, such as blood, serum, or as in this case, cerebrospinal fluid. 

Accordingly, after reviewing our policies and procedures regarding the transfer of such 

materials, we determined that further clarification is necessary. In order that NIH 
259

employees understand that formal mechanisms such as Material Transfer Agreements 

(MTAs) are required when human research materials are transferred, we are taking the 

following steps: 

• NIH will provide additional guidance to investigators on the different mechanisms 

available for entering into collaborations and transferring materials outside of the 

NIH. While we thought that the current rules were clear to most scientists, we think 

it is necessary to clarify that a MTA should be used when transferring materials. 

Scientists should use research collaborative agreements, or Cooperative Research 

and Development Agreements (CRADAs), when entering into research 

collaborations with industry. 

• NIH will require that all transfers of samples derived from human subjects must 

involve a written mechanism – MTA, CRADA, letter of collaboration, or other 

agreement. Such agreements must be in writing to ensure compliance with all 

requirements regarding human subjects protections. Further, the use of written 

mechanisms will permit NIH to track the sharing of clinical samples with outside 

entities, and monitor compliance with the policy. 

• NIH will clarify that in cases involving the transfer of material derived from human 

subjects, all such written agreements must be accompanied by more rigorous checks 

and balances, including the review and approval by senior leadership at the relevant 

Institute. 

• NIH has initiated a comprehensive review of policies across NIH involving MTAs 

to determine if additional requirements are necessary in the case of MTAs that do 

not involve the transfer of material derived from human participants. NIH policy 

requires the widespread dissemination of research tools. It is not clear, however, 

that such enhanced protections should be required for all materials, such as 

laboratory-produced DNA samples, cell lines, and antibodies, whose main function 

is to accelerate research. A further analysis is necessary to inform policy 

development in this area. 

NIH has also reviewed its policies governing the use of stored human tissue 

samples. Stored human tissue samples, if identifiable by codes or other identifiers, are 

considered “human subjects” under applicable Federal regulations. The intramural 

research program’s human research protection program functions under a Federal-Wide 

Assurance (FWA) with the HHS Office for Human Research Protections (OHRP). Its 

FWA commits the intramural program to conduct its human subjects research activities 

consistent with acceptable ethical principles and in compliance with 45 CFR part 46, the 

regulation governing the protection of human subjects in research. I am responsible for 

implementing the FWA, and the Office of Human Subjects Research (OHSR) within the 

Office of Intramural Research serves this purpose. 

Research uses of previously collected and stored human samples, when intramural 

research program investigators can personally identify the sources, must be prospectively 

reviewed and approved by an Institutional Review Board (IRB). IRBs are charged by 

federal regulation (45 CFR part 46) with reviewing research protocols from the vantage 

point of protecting the rights and safeguarding the welfare of the research participants. 

When reviewing a proposed new research use of stored samples, an IRB will consider the 

original research use and carefully consider the informed consent document in order to 

determine if the new use is consistent with the original protocol. If the research is subject 

to regulation by the Food and Drug Administration (FDA) (for example, if an 

investigational diagnostic test is being studied), then the IRB would also apply FDA 

regulations. We believe the process for reviewing new uses of stored samples must be 

clear and rigorous. In order to assure that all NIH intramural research program 

researchers understand the requirements for the research use of stored samples, the 

following steps have been or will be taken: 
260

• A memorandum has been sent to all intramural clinical researchers, clinical 

directors, and scientific directors clarifying the oversight requirements for the 

collection and research use of human samples, data and specimens. 

• The Clinical Center’s Medical Executive Committee implemented procedures to 

assure that all Clinical Center protocols receive continuing NIH IRB review and 

approval as long as research analyses using coded samples continues. 

• NIH will modify its standard MTA form to include language indicating that the 

transfer of either coded or identifiable samples has been reviewed by an IRB or is 

exempt from IRB review pursuant to 45 CFR part 46 as determined by OHSR. This 

step will assist technology transfer staff in determining whether the scientist has 

adhered to human subjects requirements. 

• All research protocols in which intramural researchers intend to collect and store 

human samples, specimens, or data must include a description of the intended use 

of the samples; how the samples will be tracked; how they will be stored; what will 

happen to the samples at the completion of the protocol; what circumstances would 

prompt the investigator to report to the IRB loss or destruction of samples, and any 

proposed future use (i.e., use after termination of the protocol). Consent documents 

must include relevant language. While we cannot anticipate all prospective uses, 

we want to ensure that research participants have as much information as possible 

on how their own material will be maintained and used. 

These steps will help ensure that investigators fully understand NIH requirements 

for the research use of previously collected, stored human samples, and that proposals for 

such uses must be approved by an IRB and by OHSR. 

Science is an ongoing process that requires constant review and adaptation. The 

same is true for NIH’s programs that manage the research enterprise. Many of our 

adaptations result from internal review. Some ensue from external oversight, such as the 

work of this Subcommittee. In either case, NIH’s leadership understands we must be 

responsive. 

Sometimes the problems identified by internal and external oversight are systemic, 

but sometimes they result from individual behavior. To the extent NIH identifies 

systemic issues, we will take appropriate action. In the case of individual misconduct, 

we will seek remediation, including dismissal, where warranted. 

Thank you for this opportunity, Mr. Chairman. I will be pleased to answer your 

questions. 

 MR. WHITFIELD. Dr. Gottesman, thank you very much for your 

testimony, for being here today. First of all, as the Deputy Director for 

Intramural Research, I would like for you to explain as if you were 

addressing maybe a rotary club in Leesburg, Virginia, exactly the process 

that you need to go through if one of your research scientists at, say, the 

National Institute of Mental Health, came to you with a collaborative 

agreement and wanted to enter into a collaborative agreement with some 

third party. Could you just kind of walk us through the steps that would 

be necessary to clear that? 

 DR. GOTTESMAN. Yes. First of all, when you said come to me, you 

mean come to the appropriate authority at the institute? 

 MR. WHITFIELD. Yes. 

 DR. GOTTESMAN. So when we engage in cooperative research and 

development agreements or so-called CRADAs which are the most 
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formal of our agreements with companies, sometimes the agreement is 

initiated by an investigator who is aware of interests that accompany or 

somebody else may have in the product. Oftentimes it results from 

advertising. We actually have adverse research opportunities at the NIH 

and most often if there is an opportunity to develop a specific idea or a 

product, our technology development people will meet with the 

scientists, understand the scope of the project and then advertise that 

there are opportunities for other companies and then people apply for 

that opportunity. They are interviewed entirely by the technology 

development coordinators within the institute. At this point the 

investigator is not involved in the discussions in terms of negotiations 

except as an advisor on the scientific aspects of the research. After some 

discussions, a document is drawn up which describes in detail the nature 

of the collaboration and we require--there is a whole set of rules that 

cover what we will allow and what we won’t allow. For example, NIH 

does not do research for hire. If a company wants us to do research for 

them, we generally won’t do that unless it is clear that that is jointly 

desirable from the point of view of moving science forward. There is a 

bunch of rules and there is a policy that covers that. I am sure the 

committee is aware of that. After those discussions, there is review 

internally, a document which includes a conflict of interest review in 

which questions are asked about whether the scientists involved in the 

research have any outside personal activities with the organization, and if 

they respond that they don’t and our review indicates that that is correct 

and we do--the deputy ethics counselors at each of the institutes does 

review using Internet searches and so on. 

 MR. WHITFIELD. So they have to file a form that-- 

 DR. GOTTESMAN. There is an extensive document which is the 

CRADA application form which includes something called a conflict-ofinterest evaluation. It is not only a statement by the scientist but it is also 

a request--there is a process in which the institute actually looks into that 

statement. As you know, we are developing a better electronic system 

for tracking all of the different activities of our scientists and that will be 

an enormous help in researching whether or not there is or is not conflict 

of interest. If the institute is interested in moving forward, the 

recommendation goes to a central committee, which is the cooperative 

Research and Development Committee, which reports to me. There is a 

chair, and that committee reviews and determines whether the CRADA 

is in keeping with NIH CRADA policy, makes a recommendation. 

Sometimes some of the points of the CRADA need to be negotiated. 

And then that goes back to the institute. It gets renegotiated. It comes 

back for discussion. Our legal counsel, the Office of Technology 

Transfer, signs off and I actually sign off centrally as DDIR on all those 
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documents. So it is a very formal, very careful process to guarantee that 

there is no conflict of interest, that the research is in the interests of the 

people of this country and that it is scientifically important to move 

ahead. 

 MR. WHITFIELD. The institute from which it comes is involved, the 

Office of Intramural Research, and the Office of Technology Transfer is 

involved. Did I miss any other-- 

 DR. GOTTESMAN. Well, my office, the Office of Intramural 

Research, the Office of Technology Transfer, the technology 

development coordinators within the institutes, the committee, the 

CRADA committee. Many people. And the deputy ethics counselor 

who reviews the conflict-of-interest statement. So I would say from my 

point of view, this is a model system. It obviously takes some time to 

negotiate these agreements and it is possible during that interim period if 

there is a partner who is anxious to get research going to have a letter of 

collaboration which precedes a cooperative research and development 

agreement to allow research to move forward. 

 MR. WHITFIELD. Are there additional safeguards put into these 

collaborative agreements when human tissue samples are involved or 

not? 

 DR. GOTTESMAN. Only to the extent that we have human subjects 

regulations that I have mentioned that kick in. We have a requirement 

that if there is a CRADA involved in the study, that the IRB be informed 

about the CRADA, know how the partners are and so on. So we are 

beginning to make these connections between the different oversight 

parts of the NIH. 

 MR. WHITFIELD. So the consent forms that donors sign in providing 

human tissue samples to the institute, they disclose suppose in a rather 

broad way how this material can be used? 

 DR. GOTTESMAN. So, Mr. Chairman, if you are speaking about the 

consents that the patients-- 

 MR. WHITFIELD. Yes. 

 DR. GOTTESMAN. Yes. So the process of informed consent has been 

one of the key features of the development human subjects’ protections. 

I would say that in the early 1990s when many of the protocols were 

being conducted that we are talking about here, the consent forms were 

not very specific and in fact, in reviewing for this hearing I looked at 

some of the consents that were used in this case and it is clear that the 

patients were being--that subjects that were being asked to sign off very 

generally on use of materials. That kind of general language would not 

be allowed in the current environment. 

 MR. WHITFIELD. Now, there has been some discussion today about 

the necessity or the need for a central protocol that would extend 
263

throughout NIH, particularly relating to human specimen repositories 

and so forth, but the impression that I get from testimony is that every 

individual institute already has pretty stringent protocol for tracking this. 

Is there a real need for a broad policy throughout NIH or is it better to 

have each institute take care of that? 

 DR. GOTTESMAN. So by tradition, scientists have always controlled 

their own research activities and resources in the sense that they by virtue 

of the requirements under our research integrity program are responsible 

for keeping adequate records for storing samples in an appropriate way, 

for using these samples under all appropriate rules and regulations. This 

is part--Dr. Insel mentioned that some of the system is based on trust, 

and traditionally at the NIH and in all scientific institutions, the 

individual scientific investigator has had that responsibility. One of the 

ways in which we are dealing with whether or not those responsibilities 

are being exercised appropriately is to make sure that samples aren’t 

used for purposes other than the original intended purpose under the 

approved protocol by requiring all the different steps that I have 

mentioned. 

 I think probably what is most important is that NIH has been 

thinking very hard about ways in which we could optimize the use of 

these samples. As you point out and as many of committee members 

have pointed out, these are very valuable materials. They are unique in 

the sense that at no time or place will that individual ever be able to give 

that sample again if you are looking at a longitudinal study and 

somebody is being studied over 10 or 20 years and many of the NIH 

studies are long-term studies. The sample that goes back 20 years as a 

predictor of a disease to come is a very important sample and not easily 

reproduced although you could reproduce the whole study. 

 So we really want to be sure that these samples are used 

appropriately, and one of the things that NIH has been working on in 

keeping with actually the desire of the whole Federal government to 

create a much more electronic database for medical and clinical issues is, 

you know, what does it take to make the system entirely electronic so it 

is easily queried and you can use materials easily, and we started actually 

by developing a clinical research information system which took about 5 

years and is now in place in the clinical center which tracks all patients’ 

medical records, their test results and their images, their X-rays and so on 

so that it is possible now, and I invite you all to visit the clinical center, 

to stand at a patient’s bedside and get electronic descriptions of what 

they are doing. This is the kind of futuristic view of medicine I think 

NIH is actually taken the lead in this. Each of the institutes is developing 

in their own way clinical research tools to be able to analyze their 

specific clinical trials, and as it turns out--I had mentioned we have 22 
264

intramural programs. About 17 of them do clinical research. And the 

type of clinical research differs substantially amongst the institutes so 

each has different needs and a few different protocols are being 

developed. I just spoke to one of our scientific directors who spent 4 

years developing a data set, a tracking program for clinical samples, 

clinical trials, clinical questions that are being asked in the institute 

within one of the institutes and we talked about the feasibility of making 

that more generally available and I think that will begin to happen. 

 I think we are still up against a bit of a technical problem. The 

number of samples involved is overwhelming and we are not talking 

about, you know, putting bar codes on them as they come in. We are 

talking about going back 20, sometimes 30 years and we are talking 

about millions of samples at the NIH. So this is a big task but I think it is 

a laudable goal both from the oversight point of view and also because 

what it does is, it makes available these potential data sets to people who 

have a new idea for research. 

 MR. WHITFIELD. My time has expired. I recognize Ms. DeGette. 

 MS. DEGETTE. Thank you very much, Mr. Chairman. Dr. 

Gottesman, I want to ask you some questions that I also talked to Dr. 

Insel about and the first one is, that--and by the way, I applaud your 

determination to raise the bar here. I think it is important and I think we 

would all agree. And the Chairman was also alluding to what I talked to 

Dr. Insel about which is, we are getting ready to do NIH reauthorization 

in this committee and Dr. Zerhouni wants more centralized decisionmaking that would then take the inter-institute cooperation to a higher 

level which I think is a good idea. 

 But my question is, it seems to me that the physical tracking of these 

tissue samples, and heaven knows what else that we are keeping at NIH, 

is at a very rudimentary level, and if we are going to have more crossinstitute cooperation, which I think is really the cutting edge of medical 

research, how on Earth can we hope to achieve those laudable goals if we 

don’t really make a push for much better cataloging and much better 

cross-referencing? 

 DR. GOTTESMAN. I agree with you, and I think that-- 

 MS. DEGETTE. Well, how can we do it? Do you-- 

 DR. GOTTESMAN. Well, I mean, I have a variety of authorities and I 

also have ability to persuade people above and beyond my authority. So 

in terms of tracking samples as the institutional official human subjects’ 

research, I can require that we know that every sample has been 

approved by an IRB before it gets used, before it gets sent out and so on. 

In terms of the requirement that there be scientific tracking programs, 

electronic databases, there I use my persuasive powers to make it clear 

that these are important scientific as well as management issues for our 
265

scientific directors. We hold them responsible. I delegate to them 

responsibility for tracking human samples, making sure they are properly 

used, and under that authority, I can ask them to make sure that they 

know where the samples are. 

 MS. DEGETTE. But do you intend to have some kind of a standard 

protocol throughout the institutes that other people can access? 

 DR. GOTTESMAN. Well, as I said, the needs of each of the institutes 

are somewhat different. The type of protocols that are carried on at 

NIMH and the Cancer Institute are really quite different in kind. 

 MS. DEGETTE. Right, but what I am saying is, if you have a bunch 

of tissue samples at those two institutes, just cataloging what you have 

got there and what people are using, that is not different. 

 DR. GOTTESMAN. No. So there is a term in computer networking 

called interoperability. 

 MS. DEGETTE. Yes, I know that. 

 DR. GOTTESMAN. And if we let 1,000 flowers bloom and we say 

everybody needs to develop a system for tracking and we don’t require 

that those systems talk to each other, then we have a problem. 

 MS. DEGETTE. Sir, this is exactly what I am saying. 

 DR. GOTTESMAN. The advantage we have at NIH is, we have a 

central clinical center which is really supported by taps on each of the 

institutes. That clinical center has a database that I mentioned which 

includes all the different-- 

 MS. DEGETTE. And how long has that been in place? 

 DR. GOTTESMAN. It is about a little over a year. 

 MS. DEGETTE. So that was not in place when the-- 

 DR. GOTTESMAN. No, no. 

 MS. DEGETTE. Would that system have--right now if something like 

this happened now, would that system stop it? 

 DR. GOTTESMAN. No, that system doesn’t track clinical samples 

but-- 

 MS. DEGETTE. So what are we going to do to stop it? 

 DR. GOTTESMAN. In order for an investigator to be able to use that 

system with respect to their clinical samples, it would need to be 

interoperable so that the fact that we have invested so much in the central 

system will really force the interoperability of the other systems. They 

won’t be useful to our scientists unless they can interact with the central 

system. So what I am saying is that-- 

 MS. DEGETTE. Okay. You know, I-- 

 DR. GOTTESMAN. --we are heading in the right direction. 

 MS. DEGETTE. Okay. I may follow up with some more questions 

because I frankly don’t understand what you are saying. I want to talk to 

you about this chart. I am sure you have seen this, the one that Dr. Insel 
266

gave us, and I think it is all swell that we have all of these cross checks 

and so on, but as I was sitting here looking at this chart, if somebody 

wanted to take some tissue samples and just go outside the chart around 

the arrows, there is nothing in here that would prevent that from 

happening. If someone just wanted to do that--I mean, within the 

institutes--I think this is great, the IRBs, the board of scientific 

counselors, the Office of Technology Transfer and so on. If someone 

just wanted to take those tissue samples out, go to a pharmaceutical 

company and profit on the side, this system would not have a safeguard. 

Wouldn’t you agree? 

 DR. GOTTESMAN. Yes. So what you are saying is that if somebody-

-if we say what the rules are and somebody willfully breaks those rules 

by not reporting-- 

 MS. DEGETTE. Right, which is what happened in this case. 

 DR. GOTTESMAN. Or taking samples and not reporting that they 

have used them for that purpose. 

 MS. DEGETTE. Right. 

 DR. GOTTESMAN. There is nothing in the current system that would 

prevent that. 

 MS. DEGETTE. Right. Even in this beefed-up system. 

 DR. GOTTESMAN. And I am hard pressed in any kind of enforcement 

process to be able to answer how to prevent an individual from doing 

that except to say that there needs to be some sort of auditing function 

tied in to all of these processes so that we know maybe not for every 

person who is involved but on a representative basis how it is that the 

system is working. 

 MS. DEGETTE. Well, I have two suggestions. Number one is, if you 

beef up your tissue tracking system which we can talk about more later, 

then even if somebody is going out beyond that, if they take the issue 

samples out, you have got some kind of computer model that would say 

well, where did they go, they didn’t go over to another institute or 

something, that would be a double check. The second--because the 

evidence is gone. I used to do a lot of criminal work in practicing law, 

and if somebody went to the evidence vault at the police department and 

checked the evidence out, then it didn’t show up where it was supposed 

to show up, then you knew there was a problem. That is very simplistic 

but it is the same type of thing. And the second suggestion I would make 

is that if there is somebody who is so guilty of such gross malfeasance as 

in this case, one might want to think about how the personnel rules at the 

NIH could be modified so they could be fired before 2 years were up, 

because he is still there even after this happened. I don’t know if you 

want to comment on any of that. 
267

 DR. GOTTESMAN. Well, the only comment I would make and I know 

there is confusion about the various appointment authorities at the NIH, 

civil service versus Commissioned Corps, the Commissioned Corps is a 

separate authority. It is a uniform service and they run their operations 

similar to the uniform military code and they make determinations about 

hiring and firing people and we do not control that at NIH. 

 MS. DEGETTE. And we might want to look at that. My next 

question is around the informed consent that the people who originally 

donated these tissues for, and again, Mr. Chairman, I would ask 

unanimous consent to submit the consent form for the record. And I am 

sure you have seen this. You might even have it--you are being handed 

it. Okay. This is the original consent form that was used for Dr. 

Molchan’s study, and it seems to me--I looked it over and it seems to me 

fairly specific--you were talking earlier about you really need to look at 

the informed consent and have it be specific and have it be full, and I 

support that completely. But it looks to me like in this situation, the 

informed consent was quite specific and quite thorough for the research 

study that Dr. Molchan was saying she was conducting. Wouldn’t you 

agree with me? 

 DR. GOTTESMAN. Well, in one sense, yes, but let me point out 

something in the informed consent that perhaps you didn’t notice which 

changes the tone of it. At the end of the first paragraph, “We hope to 

obtain information on changes in hormones and brain chemicals”--that is 

very broad—“that occur in Alzheimer’s disease and in depression.”--my 

goodness, that is huge—“as well as clues to the mechanism of the action 

of lithium.” It makes it sort of clear that anything goes, and that is why I 

think an IRB in looking at this currently would just say this is not 

acceptable--you can’t ask somebody to sign off on something like-- 

 MS. DEGETTE. All right. So even though there is a lot in there, it is 

that phrase that-- 

 DR. GOTTESMAN. It is that phrase. 

 MS. DEGETTE. So it is an interesting dichotomy, isn’t it, because on 

the one hand you want to have an informed consent that is specific 

exactly to the research study but then on the other hand, what do you do 

later on if somebody wants to make a secondary use of these tissues? Do 

you have--and frankly, as Dr. Insel pointed out, with Alzheimer’s or 

many other diseases, it is likely the donor might already be dead. So 

how are you going to go back--do you think you go back and get a 

second informed consent or do you think somehow you draft this form so 

it is both specific enough to deal with this research study but broad 

enough to let you use the tissues later? 

 DR. GOTTESMAN. Right. So we have two new requirements I think 

that will clarify that point. The first is that is absolutely essential in 
268

writing up a new protocol to specify not only the intent of the protocol, 

what the study is about, but what will happen with the samples--how 

they will be stored, how long they will be kept, what will happen if 

somebody wishes to use them for another purpose, would there be reconsent, would there not be and so on. And the second point has to do 

with the requirement for IRB review. If the IRB reviews--for example, if 

these had gone before an IRB for re-review, the IRB would have looked 

at the original consent. It might have said well, this is so general that 

maybe patients understood that this was going to happen with their 

samples but in fact there is an issue over time that suggests that no one 

could have conceived of the kind of sophisticated analysis that we are 

doing now 13, 14, 15 years ago and that therefore patients need to be 

identified. In fact, Dr. Sunderland has patients who he has followed over 

the years and are still alive and were involved in some of these protocols 

and maybe they would conclude, although I don’t know for sure, that 

there would be a need for re-consent. They can either say the risk is very 

small and therefore the new research can move forward, they can waive 

consent based on the fact that they believe that there is no risk to the 

patients and the original consent covered the area, or they can request 

that there be re-consent, and we re-consent patients all the time. 

 MS. DEGETTE. You know, the other thing, and I know it is always 

on a case-by-case basis, but the subjects of this study, even though that 

statement was broad, it said this study is researching this. It didn’t say 

anything about and I give consent for future. I mean, it may be what you 

might want to look at in some cases is having people give specific 

consent for this study and then developing a secondary consent form that 

you could have and you can use these tissues for future use. 

 DR. GOTTESMAN. Well, I would be very delighted to continue this 

discussion with you because these are issues that the NIH is struggling 

with and the entire research community is struggling with. 

 MS. DEGETTE. Thank you very much, Mr. Chairman. 

 MR. WHITFIELD. Dr. Gottesman, just as a follow-up on this consent, 

do you really think that most patients care that much about how their 

samples are going to be utilized? 

 DR. GOTTESMAN. Well, there have been studies done on this issue, 

and many patients who are participants in clinical research studies, 

human subjects research studies, are actually enormously altruistic and 

they believe--they trust the scientists who are working. They want them 

to be able to use the samples to help them or to help somebody else and I 

think maybe the majority of people who participate in clinical research 

feel that way. On the other hand, sometimes they are uninformed about 

the potential risks to them. If a discovery is made about some aspect of 

their physiology that could affect their insurability or their employability, 
269

those are really important risks that need to be considered and we would 

like to be able to reassure people that even if they can’t think of 

problems, that we will be thinking about these things and making sure 

that samples are not used for purposes that could put them at any risk. 

 MR. WHITFIELD. Just a couple of other questions. In your testimony 

you stated the NIH will accomplish three things. One, you will provide 

additional guidance to investigations on material transfers; two, you will 

require that all transfers of samples derived from human subjects must 

involve putting it in writing; three, the NIH will clarify that in cases 

involving human transferred material, that there will be review and 

approval by senior leadership at the relevant institute. Now, is that 

already being accomplished or do you have a time guideline for this? 

 DR. GOTTESMAN. Right. So because this involves changes in our 

technology transfer program, I have more direct authority over the 

human subjects’ part because I’m the institutional official. So we are 

convening a group of administrators and scientists to consider all aspects 

of material transfer at the NIH, transfer from laboratories as well as 

clinical samples. I will promise this committee that those aspects that we 

promise to do will certainly take place, but there may be other changes in 

our policy as well, and we want to be able to release not piecemeal but 

altogether the policy on material transfer at the NIH that everybody 

understands, that everyone adheres to. 

 MR. WHITFIELD. And do you have a general time guideline on that? 

 DR. GOTTESMAN. I think we can probably accomplish this within a 

couple of months. 

 MR. WHITFIELD. Now, one other question. We have talked a lot 

about the collaborative research agreements and we talked about the 

material transfer agreements, and not being familiar with either one of 

them I would like to just ask you this question. We have on Exhibit #2, 

there is a material transfer agreement by the National Institutes of Health, 

the provider is Trey Sunderland, the recipient is Pfizer, which is the case 

that we have all been focused on, and in paragraph three when it talks 

about how the research material will be used, it says, “Research to 

identify and validate protein markers associated with Alzheimer’s 

disease.” Now, is that--from your background as a scientist, your 

experience, is that too broad or is that adequate or-- 

 DR. GOTTESMAN. Well, I think the problem is that this is a material 

transfer agreement that is not just transferring materials. It is specifying 

a collaborative agreement. And I think that under normal circumstances 

if this had been thoroughly reviewed by a technology development 

coordinator, the conclusion would have been that this is not an 

appropriate transfer agreement, transfer mechanism that--I always prefer 

to see CRADAs because, as I told you, the system is very formalized and 
270

works well. But it could have been done under a collaborative 

agreement with a company, but that has to be signed off by the 

technology people and the senior leadership at the NIH. So the issue 

here is not whether this is specific or not specific. It is that it is not an 

appropriate vehicle to transfer the materials. 

 MR. WHITFIELD. Okay. So it is not an appropriate vehicle? 

 DR. GOTTESMAN. I don’t believe so, no. 

 MR. WHITFIELD. Well, I will make one other comment, then I will 

recognize Mr. Stupak here. I want to ask you to do something for us. I 

would like for you to work with the National Institute of Mental Health 

to report to us on all of the underlying data that Dr. Sunderland should 

have on the GPB shipments to Pfizer that would break down by sample 

in each shipment and the protocol numbers so that we can get a more 

clear understanding of the specifics of that because in the conversations 

that we have had with the various people at NIH, we still are a little bit--

we are not sure precisely on the specifics of this. In some of the memos I 

have seen, I know that the National Institute of Mental Health referred to 

11 percent here and eight percent here was used and whatever. We 

would just like to get a more clear understanding of the exact shipments, 

the protocol numbers and so forth, and how much was utilized as it 

relates to Pfizer with Dr. Sunderland. 

 DR. GOTTESMAN. Mr. Chairman, we will do the best we can to get 

the information. As you know, there is an ongoing investigation and we 

have been generally instructed by counsel to try not to confuse the 

different investigations, but I certainly would like to get you that 

information and I will work with the people at NIH and see if we can 

make that happen. 

 MR. WHITFIELD. And Exhibit 26 may provide some help to you on 

that as well, so we can give you a copy of that before you go. We will 

get a copy to you before you go. At this time I recognize Mr. Stupak. 

 MR. STUPAK. Thank you. Dr. Gottesman, how long have you been 

at NIH? 

 DR. GOTTESMAN. I have been at NIH 31 years. 

 MR. STUPAK. Okay. In this new position as-- 

 DR. GOTTESMAN. In my current position? 

 MR. STUPAK. Yes. 

 DR. GOTTESMAN. Almost 13 years. 

 MR. STUPAK. Thirteen years. Has this issue ever arose before about 

use of samples and scientists outside? 

 DR. GOTTESMAN. There are a couple different issues. The use of 

samples for research purposes is a constant area of discussion at the NIH 

and we are constantly making policy and the policy, as I said to 

Congresswoman DeGette, is a kind of moving target. 
271

 MR. STUPAK. Well, it seems like there was policy for handling 

hazardous materials or samples but not for this here. Why was-- 

 DR. GOTTESMAN. Well, the NIH policy I think is pretty clear and 

that is dictated by all the requirements for human subjects’ research, that 

if there is a closed protocol and that somebody wants to use a sample, 

they need to get permission from the IRB to use that sample. There is an 

oversight responsibility. 

 MR. STUPAK. So here there should have been an IRB and then was it 

46 CFR 45, was that--that should have been followed? 

 DR. GOTTESMAN. Right. That is the controlling legislation, yes. 

 MR. STUPAK. And that should have been followed, right? 

 DR. GOTTESMAN. That should have been followed. What was not 

made clear earlier this morning was that actually some of these protocols 

are still open. Some of the samples were sent under open protocols and 

some of them were sent under closed protocols. There were a total of 16 

protocols. 

 MR. STUPAK. Right. 

 DR. GOTTESMAN. And 11 of them had been closed prior to the 

period when the samples were sent. 

 MR. STUPAK. So-- 

 DR. GOTTESMAN. Five of them are still open and undergoing 

continuous IRB review. 

 MR. STUPAK. Okay. And then the IRB--it is my understanding Dr. 

Sunderland was head of the IRB, right? 

 DR. GOTTESMAN. At one--during this period he was the chair of the 

IRB, yes. 

 MR. STUPAK. So who would he get permission from then to-- 

 DR. GOTTESMAN. The original review and approval of the protocols 

that allowed the samples to be collected were done with an IRB chair 

who was another person. He was recused-- 

 MR. STUPAK. Well, the original samples, I guess there are no 

questions there but then they were moved outside for commercial gain, if 

he is head of the IRB, who would he get his permission from? 

 DR. GOTTESMAN. So in the course of reviewing the human subjects’ 

materials, we found that in some cases Dr. Sunderland did sign off 

during the continuing review process on protocols in which he was a coinvestigator. 

 MR. STUPAK. So he should have received permission or someone 

sign off-- 

 DR. GOTTESMAN. Someone else should have done that. That was-- 

 MR. STUPAK. With this new flow chart, will that work? I mean, 

really. I know we had some comments about this. You are talking about 
272

this flow chart here, and how does that make--like if I am head of the 

IRB, where do I go then to get my permission? 

 DR. GOTTESMAN. I mean, this is one of the very basic principles of 

the conduct of any human affair. If it is your business which is being 

reviewed, you don’t sit as a chairman on the committee that reviews it. 

 MR. STUPAK. So really what it comes down to, it is not this colorful 

chart. It really comes down to the integrity of the individual? 

 DR. GOTTESMAN. Well, and the institution. I mean, that should not 

have been allowed. 

 MR. STUPAK. Right. But in order to bypass the safeguards that any 

institution puts in whether it is NIH or Congress, it still boils down to the 

individual, whether or not they are going to follow that protocol, whether 

they are willing to take that risk and what is the benefit to them, almost 

like a cost-benefit analysis in a way. 

 DR. GOTTESMAN. Well, as I said to Congresswoman DeGette, it is 

based on trust but at the same point, we can develop oversight 

mechanisms that reduce the likelihood that any one individual will 

absolutely violate the rules. 

 MR. STUPAK. Sure. You indicated in your testimony to the 

Chairman here that there is still ongoing investigation in this matter. Is 

that true? 

 DR. GOTTESMAN. Yes, that is true. 

 MR. STUPAK. What area is the ongoing investigation still going on? 

 DR. GOTTESMAN. Well, I mean, Dr. Insel mentioned this morning 

that the AG and the Justice Department have shown some interest in this 

case and I don’t know the state of-- 

 MR. STUPAK. It is nothing else that NIH is doing other than if 

Justice asks for something-- 

 DR. GOTTESMAN. Well-- 

 MR. STUPAK. --you will provide them with the information? 

 DR. GOTTESMAN. Following a meeting that I had with the counsel 

for this committee, when I was made aware of what I thought were 

problems with the human protections issues, I initiated through my own 

office and through the Office of Human Subjects Research a paper 

investigation of the various paperwork-- 

 MR. STUPAK. That investigation is done though, right? 

 DR. GOTTESMAN. It is not completed yet but it is in progress and we 

have already made a report to the Office of Human Research Protections 

about it. 

 MR. STUPAK. You said you met with House counsel here or 

committee counsel, I should say, excuse me. So were you part of the 

team at NIH that put together the information that the committee 

requested? 
273

 DR. GOTTESMAN. My involvement was actually minimal. I mean, 

NIH separates the oversight of the science from the management issues 

related to disciplining scientists, for example, but I was involved at one 

step, which was--there was a committee put together to determine 

whether in fact there was an overlap between the outside activity and the 

official duty activity. 

 MR. STUPAK. Right. 

 DR. GOTTESMAN. It was a committee of scientists. 

 MR. STUPAK. That is a little different than what I am asking. This 

committee had a hearing in 2004 on this issue. We followed it up. 

Myself and Mr. Whitfield, Chairman Barton, Mr. Dingell, signed a letter 

in June of 2005 asking for certain information. Were you part of the 

NIH team that helped put together the response? 

 DR. GOTTESMAN. Yes. Actually, our legislative people came to my 

office and gave me the questions and asked if I could help get some of 

the information about what was existing NIH policy. The initial 

questions were about storage of samples, freezer stability, and so on, and 

what were policies concerning oversight, and we provided information 

about human subjects and material transfer. 

 MR. STUPAK. And how about the follow-up letter of January 4, 

2006, and January 26, 2006, by this committee, were you part of that 

team that put together those answers? 

 DR. GOTTESMAN. I am not sure what those refer to but-- 

 MR. STUPAK. Is there any question as to whether or not the human 

tissue samples collected by NIH scientists using government resources 

are property of the Federal government? 

 DR. GOTTESMAN. There is no question they are property of the-- 

 MR. STUPAK. Under what authority do you make that statement? 

 DR. GOTTESMAN. The legal authority. I think there is probably 

some place in the legal code--I mean, this is something that every 

scientist who comes to NIH is told: Every product of your research here 

belongs to the Federal government. 

 MR. STUPAK. Everyone has testified to that but no one can point us 

to the authority. 

 DR. GOTTESMAN. I can certainly have our legal people research it 

and get you an answer to that. 

 MR. STUPAK. Okay. I mean, the issue came up yesterday too. It 

was asked a couple times. At the NIH, is there a policy regarding data 

that is over 5 years old? You know, there has been some testimony that 

Dr. Sunderland indicated that everything was purged and therefore the 

data wasn’t available anymore. 

 DR. GOTTESMAN. So our research integrity policy which has to do 

with what scientists are expected to do in terms of maintaining their 
274

notebooks and their samples and so on states that samples need to be 

kept for 5 to 7 years. The new requirements from the Office of Research 

Integrity, which is part of the Department of Health and Human Services, 

are fully 7 years and we are in the process--and that is a new 

requirement--we are in the process of aligning our requirement with that 

requirement. So the department requirement will be retention of 

materials, data, samples for 7 years. 

 MR. STUPAK. Then what happens to it after that? 

 DR. GOTTESMAN. Then they can be destroyed or--they can’t be used 

for purposes other than the intended purpose, but they can certainly be 

destroyed. 

 MR. STUPAK. In this case, with the lithium study, was any of that 

destroyed, any of that data or research information destroyed? 

 DR. GOTTESMAN. I have no idea. I know at some point there was an 

e-mail which stated that the material had been purged, the information 

had been purged but I don’t know if that actually happened. 

 MR. STUPAK. Let me ask you this question, if I may. The rules at 

NIH concerning consulting between like NIH and scientists and private 

industry I am sure have changed since Dr. Sunderland. I am concerned, 

however, that the abuses of the system from which Dr. Sunderland 

profited were not only due to lack of regulation but in fact the lack of 

enforcement of this regulation. How can you assure this committee that 

there is now an appropriate level of actual enforcement other than this 

chart? I like the chart but it doesn’t do much for us. 

 DR. GOTTESMAN. Right. Well, one of the points I made in my 

testimony is, it is not sufficient to make policy. You have to be sure that 

people understand it, understand the reason for it, have support in order 

to be able to carry out, and know that there are consequences if they 

don’t follow it. And I think that the current environment at NIH is much 

more sensitive to the need for oversight and management. Some mention 

was made about the culture of scientists and the culture of administrators. 

I think one of the things that I have been working on for sure is 

convincing scientists that management of science is just as important as 

the conduct of their science. 

 MR. STUPAK. Your deputy ethics counselor, that is in place now? 

 DR. GOTTESMAN. Yes, so what this represents is-- 

 MR. STUPAK. Let me ask you this. I don’t mean to interrupt but 

time is running short. Does this chart, does it apply to the Corps? We 

have had testimony that you can’t do things about Dr. Sunderland 

because he is part of the Corps. Would this all apply to the Corps also? 

 DR. GOTTESMAN. Yes. Anyone who is in the Corps who works at 

NIH is subject to all the same rules and regulations. 
275

 MR. STUPAK. So if I violate whether I am in the Corps or whether I 

am at NIMH but not part of the Corps, if I violate one of these rules I 

could be terminated, I don’t need the Corps permission then? 

 DR. GOTTESMAN. No. The problem is that if you are appointed in 

the Corps, the Corps makes the determination about whether you can be 

terminated. 

 MR. STUPAK. But yet this so-called accountability chart, if you will, 

or whatever you want to call it, your chart here, this is going to apply to 

the Corps? 

 DR. GOTTESMAN. The requirements for people who work at the NIH 

are the same whether they are appointed-- 

 MR. STUPAK. Corps or civil service or independent-- 

 DR. GOTTESMAN. The decision about hiring and firing is made by 

the Corps, not by the NIH. That is the issue. 

 MR. STUPAK. I just want to make sure the Corps is going to accept 

this. 

 DR. GOTTESMAN. They do and they will. 

 MR. STUPAK. Okay. Thank you, Mr. Chairman. 

 MR. WHITFIELD. One other question, Dr. Gottesman. In response to 

Mr. Stupak, you talked about human tissue samples can be destroyed 

after 5 to 7 years. Is that mandatory or is that just-- 

 DR. GOTTESMAN. No. I guess it is an expectation that materials--we 

don’t expect them to be retained for more than 7 years. In many cases 

for the clinical samples that obviously continue to be valuable samples, 

they should be maintained and I think it an interesting issue. Most of our 

scientists will continue to keep them, hoard them in their freezers and 

hoping that they will be useful at some future time. 

 MR. WHITFIELD. Yes, because you can freeze these fluid samples 

for I guess forever, right? 

 DR. GOTTESMAN. Well, the issue about actually what the lifetime is 

of these samples in the freezer is a scientific question and I think has not 

been resolved, at least to my satisfaction. 

 MR. WHITFIELD. It depends on what you are going to use them for 

and so forth. Okay. Dr. Gottesman, thank you very much for your 

testimony. We appreciate your being here today and we look forward to 

working with you as we move forward to maintain the integrity and the 

sterling reputation of NIH. Thank you. This hearing is adjourned. 

 [Whereupon, at 12:55 p.m., the subcommittee was adjourned.] 
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RESPONSE FOR THE RECORD OF THOMAS R. INSEL, M.D., DIRECTOR, NATIONAL INSTITUTE 

OF MENTAL HEALTH, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH 

AND HUMAN SERVICES
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RESPONSE FOR THE RECORD OF WILLIAM FITZSIMMONS, EXECUTIVE OFFICER, NATIONAL 

INSTITUTE OF MENTAL HEALTH,, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES
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RESPONSE FOR THE RECORD OF MICHAEL M. GOTTESMAN, M.D., DEPUTY DIRECTOR FOR 

INTRAMURAL RESEARCH, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES
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RESPONSE FOR THE RECORD OF DAVID L. FRIEDMAN, PH.D. 

The Honorable Bart Stupak

Question(s) for David Friedman, Ph. D. 

Formerly with Pfizer, Inc. 

June 13, 2006 

Subcommittee on Oversight and Investigations 

Hearing entitled: “Human Tissue Samples: NIH Research Policies and Practices” 

1. In his report to an NIMH internal review board, Dr. Sunderland characterized 

the three-way collaboration involving NIMH, Pfizer, and Oxford 

Glyocsciences, which yielded no data or publications for NIMH, as 

unsuccessful. Would you agree with this assessment? 

No. I thought it went quite well in a scientific sense. 

2. If the collaboration did indeed produce significant findings, why would Dr. 

Sunderland characterize it as a failure? Would he have any reason to think this 

was the case? 

I noticed that you transitioned from “unsuccessful collaboration” in (1) to a question of 

failure to produce significant findings in (2). I think the jury is still out on the general 

utility of these markers as they traverse the validation process. Pfizer continues to update 

the patent application periodically, perhaps with new and meaningful marker data. That 

data should be more visible when the patent issues. Perhaps Dr Sunderland felt it was a 

failure because nothing got published. Perhaps someone should look into that. 

3. Did it strike you as odd that Dr. Sunderland did not want to be mentioned in 

publicity associated with the collaboration involving OGS? 

Not really, it wasn’t exactly clear why, but not of a scientific concern. 

4. Did Dr. Sunderland ever mention why he did not want to be listed? Would 

there be any reason for a researched interested in publication, and involved in a 

good-faith collaboration, to not wish to be listed in publicity of this kind? 

Not clear to me why. 

5. How regularly did Dr. Sunderland visit your lab or OGS while you were in 

charge of the “unknown biomarkers” research? 

First of all, I wasn’t “in charge” of the research as you suggest above. I was the scientific 

leader, albeit with several layers of management above me also on the team (e.g., 

Michael Silber, Steve Williams). In terms of the regularity of visits, at least quarterly at 

Pfizer, with perhaps one or two additional visits per year for special “data-driven” events. 

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