CONTINUING ETHICS AND 

MANAGEMENT CONCERNS AT NIH 

AND THE PUBLIC HEALTH SERVICE 

COMMISSIONED CORPS 

HEARING 

BEFORE THE 

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE 

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED NINTH CONGRESS 

SECOND SESSION 

SEPTEMBER 13, 2006 

Serial No. 109-136 

Printed for the use of the Committee on Energy and Commerce 

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

U.S. GOVERNMENT PRINTING OFFICE 

WASHINGTON : 2006 

For sale by the Superintendent of Documents, U.S. Government Printing Office 

Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC area (202) 512-1800 

Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001 

31-462PDF 
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 

Testimony of: 

Agwunobi, Hon. John, Assistant Secretary of Health, U.S. Department of Health and 

Human Services ............................................................................................................ 319 

Kingston, Dr. Raynard, Deputy Director, National Institutes of Health, U.S. 

Department of Health and Human Services .................................................................. 327 

(III) 

(1) 

CONTINUING ETHICS AND 

MANAGEMENT CONCERNS AT NIH AND 

THE PUBLIC HEALTH SERVICE 

COMMISSIONED CORPS 

WEDNESDAY, SEPTEMBER 13, 2006 

HOUSE OF REPRESENTATIVES, 

COMMITTEE ON ENERGY AND COMMERCE, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

Washington, DC. 

 The subcommittee met, pursuant to notice, at 1:03 p.m., in Room 

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

(Chairman) presiding. 

 Members present: Representatives Whitfield, Burgess, Blackburn, 

Barton (ex officio), Stupak, and Dingell (ex officio). 

 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; Matthew Johnson, Legislative Clerk; Christa 

Carpenter, Counsel; David Nelson, Minority Investigator/Economist; and 

Jonathan Brater, Minority Staff Assistant. 

 MR. WHITFIELD. I call the hearing to order this afternoon, and 

today’s subject is continuing ethics and management concerns at NIH 

and the Public Health Service Commissioned Corps. 

 This hearing builds on our previous oversight hearings in 2004 on 

NIH ethics and hearings in 2006 on NIH’s handling of human tissue 

samples. In the last 2 years, NIH has been faced with unprecedented 

ethics concerns. Based largely on information provided by the 

committee, NIH conducted its own investigations and found 52 

individuals in violation of ethics rules. The full results of these 

investigations have been submitted to the committee and now we 

consider whether NIH and the Corps have vigorously enforced the rules. 

 Two of the most serious cases involve Dr. Trey Sunderland of the 

National Institute of Mental Health and Dr. Thomas Walsh of the 

National Cancer Institute, both of whom happen to be officers in the 

Corps. In both of these cases, we are troubled about whether NIH and 

the Corps has acted appropriately. In the case of Dr. Sunderland, we had 

questions about why NIMH continued to deal with Dr. Sunderland in a 

business-as-usual way while he was under investigation and his 
2

retirement from NIH was on hold. In 2005, it was determined that Dr. 

Sunderland had engaged in undisclosed, unreported, and unapproved 

consulting for activities in which he was paid over $700,000 and that 

some of his consulting conflicted with his government job. In November 

2005, Dr. Thomas Insel, the Director of the National Institute of Mental 

Health, proposed to the Corps that Dr. Sunderland be considered for 

termination but except for not receiving a $12,000 bonus. Dr. 

Sunderland has continued to enjoy privileges that belong to the dedicated 

NIH scientists and Corps officers who faithfully followed the rules. 

 Did NIMH take steps to prevent Dr. Sunderland from representing 

them and going on taxpayer-funded trips? No. In one case, Dr. 

Sunderland took a taxpayer-funded trip costing over $3,000 to a 

scientific association meeting in Hawaii in December 2005 only a few 

weeks after Dr. Insel had proposed that Dr. Sunderland be terminated 

from the Corps. Was Dr. Sunderland as a Commissioned Corps officer 

deployed to help on Hurricane Katrina or Rita relief? No, but NIMH did 

clear him to go to Geneva, Switzerland, in September for a couple of 

days at taxpayer expense. Were steps taken even after Dr. Sunderland 

took the Fifth Amendment at the June subcommittee hearing? No. Was 

he denied the ability to engage in paid activities outside his employment? 

No. Did they even take away his title of Branch Chief even after Dr. 

Sunderland’s branch was in effect closed? No. After integrity questions 

were raised, did NIMH take steps to restrict Dr. Sunderland’s access to 

confidential data? No. 

 Dr. Insel told us at the June 14 hearing that his hands were tied to 

take any action on Dr. Sunderland because Dr. Sunderland was a 

Commissioned Corps officer, but after the committee staff raised 

questions about why NIMH continued to approve trips and activities for 

Dr. Sunderland, Dr. Insel did in August 2006 finally restrict Dr. 

Sunderland from traveling to represent NIMH. 

 Dr. Walsh also presents another serious case. Over a 5-year period, 

Dr. Walsh engaged in unreported and unapproved consulting with 25 

companies taking more than $100,000 in payments. The NIH ethics 

panel determined in the one activity it has reviewed involving Dr. Walsh 

that there were conflict-of-interest violations. Although the Corps 

received a proposal for Dr. Walsh’s termination at the beginning of this 

year, the Corps chose not to act on the Walsh matter. Given the 

paramount interest in protecting the integrity of the Corps and NIH, we 

must ask the question, why didn’t the Corps act on the Walsh case? 

Instead of being proactive, it appears that the Corps and the NIH seemed 

passive really on this issue, taking the minimum steps to enforce the 

rules that are the foundation of maintaining public trust. We know that 
3

public trust is vitally important, and in our previous hearings on this 

subject, that has been emphasized. 

 We recognize that NIH has taken needed steps to improve the ethics 

program, but more action is needed. The NIH system is one of multiple 

silos of information holding financial records, outside activity forms, 

recusals and waivers, leave records, technology transfer agreements, and 

human subject protection records. However, these silos are not yet 

connected to each other to provide an informed review. 

 Through these hearings, we expect the Corps and NIH to improve 

their systems to prevent these violations, detect them better when they 

occur, and to act decisively and appropriately. We look forward to the 

testimony of all the witnesses today, and I will certainly be introducing 

you all after Mr. Stupak and other members have made their opening 

statements. At this time I recognize the Ranking Minority Member, Mr. 

Stupak, for his opening statement. 

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

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

OVERSIGHT AND INVESTIGATIONS

 Today the Subcommittee examines continuing ethics and management concerns at 

the National Institutes of Health (NIH) and the Public Health Service Commissioned 

Corps. This hearing builds on our previous oversight hearings in 2004 on NIH ethics and 

hearings in 2006 on NIH’s handling of human tissue samples. 

 In the last two years, NIH has been faced with an unprecedented ethics mess. Based 

largely on information provided by the Committee, the NIH conducted its own 

investigations and found 52 individuals in violation of ethics rules. The full results of 

these investigations have been submitted to the Committee and now we consider whether 

NIH and the Corps have vigorously enforced the rules. 

 Two of the most serious cases involve Dr. Trey Sunderland of the National Institute 

of Mental Health (NIMH) and Dr. Thomas Walsh of the National Cancer Institute (NCI), 

both of whom happen to be officers in the Corps. In both of these cases we are troubled 

about whether the NIH and the Corps acted appropriately. 

 In the case of Dr. Sunderland, we have questions about why NIMH continued to 

deal with Dr. Sunderland in a “business as usual” way while he was under investigation 

and his retirement from NIH was on hold. In 2005 NIH had determined that Dr. 

Sunderland had engaged in undisclosed, unreported, and unapproved consulting for 

activities in which he was paid over $700,000, and that some of consulting conflicted 

with his government job. In November 2005, Dr. Thomas Insel, the Director of the 

National Institute of Mental Health, proposed to the Corps that Dr. Sunderland be 

considered for termination. 

 But except for not getting a $12,000 bonus, Dr. Sunderland has continued to enjoy 

privileges that belong to the dedicated NIH scientists and Corps officers who faithfully 

followed the rules. Did NIMH take steps to prevent Dr. Sunderland from representing 

the NIMH and going on taxpayer-funded trips? No. In one case, Dr. Sunderland took a 

taxpayer-funded trip costing over $3000 to a scientific association meeting in Hawaii in 

December 2005, only a few weeks after Dr. Insel had proposed Dr. Sunderland’s 

termination to the Corps. Was Dr. Sunderland as a commissioned corps officer deployed 

to help on Hurricane Katrina or Rita relief? No, but NIMH did clear him to go to 
4

Geneva, Switzerland in September for a couple of days at taxpayer expense. Did NIMH 

take such steps even after Dr. Sunderland took the Fifth Amendment at the June 

Subcommittee hearing? No. Did NIMH deny Dr. Sunderland the ability to engage in 

paid outside activities? No. Did NIMH even take away Dr. Sunderland’s title of branch 

chief even after Dr. Sunderland’s Branch was in effect closed? No. After integrity 

questions were raised, did NIMH take steps to restrict Dr. Sunderland’s access to 

confidential data? No. 

 Dr. Insel told us at the June 14th hearing that his hands were tied to take any action 

on Dr. Sunderland because Dr. Sunderland was a Commissioned Corps officer. But after 

the Committee staff raised questions about why NIMH continued to approve trips and 

activities for Dr. Sunderland, Dr. Insel in August 2006 finally restricted Dr. Sunderland 

from traveling to represent NIMH and from no longer getting approval for certain outside 

activities, and reassigned him to the extramural branch. 

 Dr. Walsh presents another serious case. Over a five-year period, Dr. Walsh 

engaged in unreported and unapproved consulting with 25 companies, taking more than 

$100,000 in payments. The NIH Ethics Panel determined in the one activity it has 

reviewed involving Dr. Walsh that there were conflict of interest violations. Although 

the Corps received a proposal for Dr. Walsh’s termination at the beginning of this year, 

the Corps chose not to act on the Walsh matter. Given the paramount interest in 

protecting the integrity of the Corps and the NIH, why didn’t the Corps act on the Walsh 

case? 

 Instead of being proactive, both the Corps and the NIH seem passive, taking the 

minimal steps to enforce the rules that are the foundation of maintaining public trust. I 

do recognize that NIH has taken needed steps to improve its ethics program, but more 

action is needed. The NIH system is one of multiple silos of information holding 

financial reports, outside activity forms, recusals and waivers, leave records, technology 

transfer agreements, and human subject protection records, but these silos are not yet 

connected to each other to provide an informed review. Through these hearings, we aim 

to get the Corps and the NIH to improve their systems to prevent violations, detect them 

better when they occur, and to act decisively and appropriately. 

 I thank the witnesses and look forward to their testimony. I thank the Minority side 

for its work in this investigation. I now recognize my friend, the Ranking Member of the 

Subcommittee, Bart Stupak, for his opening statement. 

 MR. STUPAK. Thank you, Mr. Chairman. 

 This hearing is a result of a 4-year investigation by the Oversight and 

Investigations Subcommittee. Four years after this subcommittee 

pointed out conflict-of-interest problems at the National Institute of 

Health, this agency still does not have any safeguards to prevent the 

types of abuse as we previously discovered. The National Institute of 

Health spends $29 billion of taxpayers’ money on biomedical research. 

It operates with wide latitude to focus our resources on most promising 

lines of research and yet the National Institute of Health cannot rid itself 

of conflict of interest. 

 Today three institutions will be singled out for their failure to prevent 

conflicts of interest. First and foremost is the Office of Inspector 

General, an office that has not been called to appear before us today, and 

I do not know why not. They should be here. Three years ago this 

subcommittee identified over 100 National Institutes of Health 
5

employees that had not reported income from drug and biotech 

companies. At that point the Office of Inspector General should have 

been the first agency to investigate files, interview the possible violators 

and their supervisors, peers and subordinates. The Inspector General 

should have immediately and aggressively obtained all pertinent 

information in the possession of the drug companies regarding the 

alleged payments. Instead, the Office of Inspector General did nothing. 

Simply put, the Office of Inspector General failed to fulfill its statutory 

responsibility. Instead, the office delegated whatever investigations 

might be done to the NIH itself. 

 Then we have the Public Health Service Corps represented today by 

Assistant Secretary for Health since there is no Surgeon General at this 

time. The Public Health Service, also referred to as Commissioned 

Corps, is organized along paramilitary lines and enlistment is open to 

certain professionals at the National Institutes of Health and in the 

Department of Health and Human Services. The Public Health Service 

Corps is an organization that accepts no responsibility for the 

performance of its employees at the NIH including the ethical behavior 

of its officers, but is charged with administering all discipline in excess 

of 14 days, suspension. Last fall the National Institutes of Health 

informed the Public Health Service that two of its employees would be 

terminated if they were civilians and they had not been employed 

correctly by the NIH but yet to date the Commissioned Corps has taken 

no action. This arrangement leaves the National Institutes of Health in a 

compromised position, having limited ability to discipline its researchers. 

Furthermore, it is unclear what, if any, advantage the National Institutes 

of Health gains from having employees that have joined the Public 

Health Service and are technically assigned or detailed to their jobs by 

the Public Health Service. The overriding rationale is that the medical 

doctors and other doctors of the Public Health Service are on duty 24/7 

and may be assigned anywhere anytime to handle public health crisis. In 

fact, a number of the Commissioned Corps medical doctors were 

assigned to assist with the public health disasters in the wake of 

Hurricanes Katrina and Rita. Curiously, though, Dr. Trey Sunderland, 

who had lost his lab and was awaiting disciplinary action, was not sent to 

the Gulf Coast. Instead, Dr. Sunderland, a public service officer who 

asserted his Fifth Amendment rights rather than explain his conduct to 

this subcommittee, was permitted to attend a conference in Switzerland 

while New Orleans was underwater. I expect our witnesses today to 

explain this curious pampering of Dr. Sunderland in this instance. 

 Finally, like in previous hearings, the National Institutes of Health 

and particularly the National Institute of Mental Health have much 

explaining to do. Specifically, I and others want to understand if the 
6

work that Dr. Sunderland performed for the last 2 decades at the 

taxpayers’ expense was as a matter of science worth the millions of 

dollars that taxpayers invested or an opportunity for personal financial 

gain and professional boasting. Dr. Sunderland’s studies included 

Alzheimer’s patients and their families from which blood and spinal fluid 

samples were taken over time with the goal of trying to identify 

biomarkers that would predict the early onset of this terrible disease. We 

know, for example, that Pfizer and other drug companies consider these 

samples and related patient histories invaluable and paid Dr. Sunderland 

for turning over these public samples. We know that senior officials at 

the National Institutes of Health bent over backwards to allow Dr. 

Sunderland to continue this research in New York despite their 

knowledge of serious ethical and possible criminal charges pending 

against Dr. Sunderland. This subcommittee suspects that Dr. Sunderland 

assumed this New York research while on the National Institutes of 

Health payroll without formal authorization. Is this another example of 

ethical lapse and failure to assert accountability over Dr. Sunderland? 

 What I cannot understand is why the National Institutes of Health, 

what is their plan to do with Dr. Sunderland’s very expensive and 

possible value Alzheimer’s study. We are told that the National Institute 

of Mental Health will not continue to fund it, and both the Institute on 

Aging and the Institute on Neurological Disorders and Stroke have no 

interest in pursuing this research. Why is that? If this research was 

important enough to spend millions of dollars a year for over a decade 

and if no one has developed biomarkers that predict the onset of 

Alzheimer’s, and if there seems to be a consensus that early detection is 

critical in understanding and delaying the progression of this disease, 

then why is the National Institutes of Health going to abandon these 

patients and the hope for a cure? Does this mean any time a National 

Institutes of Health researcher is caught with his or her hand in the 

cookie jar that research in their field is terminated? Why wasn’t the 

study reassigned 2 years ago when it was discovered that Dr. Sunderland 

was ethically compromised? What is the National Institutes of Health’s 

responsibility to study early onset of Alzheimer’s? Why has Dr. 

Sunderland not been removed from the National Institutes of Health 

projects despite the allegations? The National Institutes of Health, the 

Public Health Service, and the Inspector General have much to explain. 

 I hope for some honest accountability today. If the National 

Institutes of Health cannot discipline Dr. Sunderland and if the Public 

Health Service is tardy in taking action and the Office of Inspector 

General failed to investigate, then the question must be asked, is anyone 

accountable? Who has the responsibility to hold individuals accountable, 
7

or is the NIH simply broken down, cannot fulfill its mission for the 

American people in a responsible, ethical, and professional manner. 

 With that, Mr. Chairman, I yield back. 

 MR. WHITFIELD. Thank you, Mr. Stupak. At this time, Mrs. 

Blackburn, you are recognized for 5 minutes. 

 MRS. BLACKBURN. Thank you, Mr. Chairman. In the interest of 

time and knowing that we are going to have a vote, I will submit my 

statement, and just to welcome our witnesses. We hope that we will 

have the opportunity to have a dialog with you and to get some 

information. This is a tremendous concern to us. What has been 

perceived as arrogance by some of our agencies and avoidance of dealing 

with ethical and management issues is of concern to us and we hear 

about it from our constituents. So we look forward to a frank discussion. 

Thank you. 

 MR. WHITFIELD. Thank you, Mrs. Blackburn. I am going to ask 

unanimous consent to introduce the binder, our document binder, into the 

record. Without objection, so ordered. 

 [The information follows:] 
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 MR. WHITFIELD. The Chairman of the full committee, it is my 

understanding, is on his way and I am sure he will want to make an 

opening statement when he arrives, but in the meantime, I want to go and 

introduce our panel of witnesses today and I want to thank you for 

coming, and you can tell by the opening statements the concerns that we 

have and we do look forward to your testimony and answers to our 

questions. 
313

 The first witness today is the Honorable John Agwunobi, who is the 

Assistant Secretary of Health at the Department of Health and Human 

Services. We also have Dr. Raynard Kington, who is the Deputy 

Director of the National Institutes of Health. We have Dr. John 

Niederhuber, who is the Director of the National Cancer Institute. We 

have Dr. Thomas Insel, who is the Director of the National Institute of 

Mental Health, and then we have Mr. William Fitzsimmons, who is the 

Executive Officer at the National Institute of Mental Health at the 

National Institutes of Health. We welcome all of you. Thank you for 

being here. 

 As you know, this is an Oversight and Investigations Subcommittee 

hearing and we always take our testimony under oath, and I assume you 

do not have any objection to testifying under oath. And I would also say 

you are always entitled to legal counsel. I am assuming none of you 

have legal counsel here today, but if you do--do any of you have legal 

counsel? Okay. Well, if you would stand raise your right hand I will 

swear you in. 

 [Witnesses sworn] 

 MR. WHITFIELD. Thank you very much. At this time all of you are 

under oath, and what we are going to do, Mr. Agwunobi, we are going to 

allow you to give your testimony first. Here comes the Chairman now. 

So what we will do, before you begin your testimony, we will recognize 

Chairman Barton for any opening statement that he may have at this 

time. 

 CHAIRMAN BARTON. Thank you, Chairman Whitfield. I was 

downtown at a luncheon for the Boy Scouts and former Chairman Tauzin 

was the master of ceremonies, so it took a while. I apologize to our 

witnesses. 

 I think this is a very important oversight hearing as we begin to move 

towards reauthorization of the National Institutes of Health. We released 

a bill yesterday and we are getting great reviews on it, and hopefully we 

have a legislative hearing next week and go to markup very soon. 

 At our last NIH oversight hearing in June, Dr. Thomas Insel, the 

Director of the National Institute of Mental Health, told us that when it 

comes to ethics, NIH has to be better than clean. In his words, it has to 

be Camelot. Unfortunately, one of the scientists at his institute, a 

multiple and serious violator of the ethics rules in the eyes of the NIH, 

Dr. Trey Sunderland, still comes to work at NIH every day and collects 

his salary. Until recently, Dr. Sunderland was going on taxpayer-funded 

trips to Hawaii and other locales, was making thousands of dollars in 

outside income, all with the blessings of Dr. Insel and his managers. 

Although he proposed Dr. Sunderland’s termination to the 

Commissioned Corps in November of 2005, Dr. Insel also recommended 
314

a $15,000 retention bonus for Dr. Sunderland in January of 2006. That 

just doesn’t make sense. Dr. Sunderland continues to have access to 

confidential data. Dr. Sunderland continues to have access to NIH staff 

and property. We now know that Dr. Sunderland has shipped his 

personal effects to his future employer at taxpayer expense. Without any 

waiver or approval from NIH, he took tissue samples and patient-related 

records and used NIH staff to help box it and send it to the future 

employer in New York State. 

 Everybody here remembers Dr. Sunderland’s visit when he invoked 

his Fifth Amendment right under the Constitution against selfincrimination. That is his right, and we honor it, but we believe that he is 

the first scientist to ever take the Fifth Amendment rather than tell 

Congress what he has been doing. He refused to answer questions about 

what he did with spinal fluid samples from his patients who participated 

in a taxpayer-funded study. That seems to have made relatively little 

difference to Dr. Insel. Before the committee staff raised questions, did 

Dr. Insel or other supervisors treat Dr. Sunderland differently after the 

hearing? Apparently not. Dr. Sunderland is also a Commissioned Corps 

medical officer. Did the Corps do anything to uphold its high ethical 

standards? There is little evidence to suggest that they have done so. 

 Now we have another case of an NIH scientist, Dr. Thomas Walsh of 

the National Cancer Institute, whom NIH found to be a serial violator of 

ethics rules. Following the same road as Dr. Insel of the NIMH, the 

director of the NCI, Dr. John Niederhuber, has proposed Dr. Walsh’s 

termination, but he has done little else that would reflect the changed 

circumstance. The Corps likewise so far has failed to act at the 

beginning of this year when it had a chance to do so. That is not 

Camelot. It is not even close. 

 This is really an ethical Potemkin village where a hollow system 

appears to provide the illusion of integrity, but transgressors never leave. 

Of the over 100 individuals who were identified by the NIH itself several 

years ago as violating NIH’s policies, not one of them, according to 

information I have, has been terminated, not one. The vast majority have 

had nothing worse happen to them than get a reprimand and continue in 

their current jobs. Some have voluntarily left the agency and sought 

employment in the private sector. Only two are still under serious 

investigation so far as we can tell. The NIH has changed its rules, and 

that is a good thing, but they don’t appear to really be doing anything to 

enforce the old rules against their most serious transgressors. So while 

NIH leaders like Dr. Insel acknowledge the ethics rules to the 

subcommittee, apparently behind closed doors at NIH there is a very 

different message that has been communicated, one that appears to look 

past or even encourage these transgressions. The shenanigans involving 
315

Dr. Sunderland using NIH resources and NIH staff to further his postNIH employment do not occur in a vacuum. They occur in an 

environment of support where he felt comfortable enough to operate 

openly. Dr. Insel did finally take some steps to restrict Dr. Sunderland 

but only after the committee staff raised questions and concerns. 

 I think it is time to tear down the illusions of ethics and build up a 

real information and management structure that protects the integrity of 

NIH and the Commissioned Corps. It may also be time to revisit the 

question of whether we need a uniformed Public Health Service at all. 

The GAO in 1996 reported that the functions of the Commissioned 

Corps are essentially civilian and could be performed efficiently and well 

by doctors and scientists without uniforms at much less cost to the 

taxpayers. 

 This is a time for serious rethinking of our ethics and management 

structure at the NIH. There should be and must be evidence of real 

enforcement. I think it is absurd that taxpayers have been footing the bill 

for nearly 2 years for Dr. Sunderland, even though he wants to leave and 

the NIH wants him out. We are going to reauthorize hopefully the NIH 

and help make it a stronger scientific agency in the very near future. It 

really does deliver for the American people, but NIH needs to regain the 

public trust. This is only going to happen if there is meaningful 

enforcement. Sensible and decisive leadership on such enforcement is a 

much-needed first step and I hope that we can see the seeds of that at this 

hearing. 

 With that, Mr. Chairman, I yield back, and thank you for your 

leadership. 

 [The prepared statement of Hon. Joe Barton follows:] 

PREPARED STATEMENT OF THE HON. JOE BARTON, CHAIRMAN, COMMITTEE ON ENERGY 

AND COMMERCE

 Thank you, Mr. Chairman, for holding this important oversight hearing as this 

Committee moves on NIH reauthorization legislation for the first time in over a decade. 

 At our last NIH oversight hearing in June, Dr. Thomas Insel, the Director of the 

National Institute of Mental Health, told us that when it comes to ethics, NIH has to be 

better than clean. In Dr. Insel’s words, “It has to be Camelot.” 

 Unfortunately, one of the scientists at his institute, a multiple and serious violator of 

the ethics rules in the eyes of the NIH, Dr. Trey Sunderland, still comes to work at NIH 

and collects his salary. Until recently, Dr. Sunderland was going on taxpayer-funded 

trips to Hawaii and other locales, and making thousands of dollars in outside income – all 

with the blessing of Dr. Insel and his managers. Although he proposed Dr. Sunderland’s 

termination to the Commissioned Corps in November 2005, Dr. Insel also recommended 

a $15,000 retention bonus for Dr. Sunderland in January 2006. Dr. Sunderland continues 

to have access to confidential data. Dr. Sunderland continues to have access to NIH staff 

and property. We now know that Dr. Sunderland shipped his personal effects to his 

future employer at taxpayer expense. Without any waiver or approval from NIH, he took 
316

tissue samples and patient-related records, and used NIH staff to help box it and send it to 

his future employer in New York. 

 Everybody here remembers Dr. Sunderland’s visit, when he invoked his Fifth 

Amendment right under the Constitution against self-incrimination before this 

Subcommittee. This is his right and we honor it, but we believe he is the first NIH 

scientist to ever take the Fifth rather than tell Congress what he’s been doing. He refused 

to answer questions about what he did with spinal fluid samples from his patients who 

participated in a taxpayer-funded study. That seems to have made relatively little 

difference to Dr. Insel. Before the Committee staff raised questions, did Dr. Insel or 

other supervisors treat Dr. Sunderland any differently after the hearing? Apparently not. 

 Dr. Sunderland is also a Commissioned Corps medical officer. Did the Corps do 

anything to uphold its high ethical standards? There is little evidence that they did. 

 Now we have another case of an NIH scientist, Dr. Thomas Walsh of the National 

Cancer Institute, whom NIH found to be a serial violator of ethics rules. Following the 

same road as Dr. Insel of the NIMH, the Director of the NCI, Dr. John Niederhuber, has 

proposed Dr. Walsh’s termination but has done little else that would reflect the changed 

circumstances. The Corps likewise failed to act at the beginning of this year when it had 

a chance to do so. 

 This isn’t Camelot, not even close. This is really an ethical Potemkin village where 

–a hollow system provides the illusion of integrity, but transgressors never leave. The 

Corps and the NIH present an elaborate structure of rules and regulations on ethical 

standards which, when tested by reality, just doesn’t seem to work. 

 Even worse, while NIH leaders like Dr. Insel acknowledge the ethics rules to the 

Subcommittee, behind closed doors at NIH a different message seems to be informally 

communicated -- one that appears to look past or even encourage these transgressions. 

The shenanigans involving Dr. Sunderland using NIH resources and NIH staff to further 

his post-NIH employment did not occur in a vacuum. They occurred in an environment 

of support, where he felt comfortable to operate openly. Dr. Insel did finally take some 

steps to restrict Dr. Sunderland, but only after the Committee staff raised questions and 

concerns. 

 Mr. Chairman, it’s time to tear down the illusion of ethics and build up a real 

information and management structure that protects the integrity of NIH and the 

Commissioned Corps. It may also be time to revisit the question of whether we need a 

uniformed public health service at all. The GAO in 1996 reported that the functions of 

the Commissioned Corps are essentially civilian and could be performed efficiently and 

well by doctors and scientists without uniforms, at less cost to the taxpayers. 

 This is a serious time for rethinking ethics and management. There must be 

evidence of real enforcement. It is absurd that taxpayers have been footing the bill for 

nearly two years for Dr. Sunderland, even though he wants to leave and the NIH wants 

him out. 

 We are going to reauthorize the NIH and help make it a stronger scientific agency 

that delivers for the American people. But NIH needs the public trust to make it happen. 

That is only going to happen if there is meaningful enforcement. Sensible and decisive 

leadership on such enforcement is a needed first step. 

 MR. WHITFIELD. Thank you, Chairman Barton. At this time we will 

recognize Mr. Agwunobi for his opening statement. 

TESTIMONY OF THE HONORABLE JOHN AGWUNOBI, 

ASSISTANT SECRETARY FOR HEALTH, U.S. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES; DR. 
317

RAYNARD KINGTON, DEPUTY DIRECTOR, NATIONAL 

INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES; DR. JOHN 

NIEDERHUBER, DIRECTOR, NATIONAL CANCER 

INSTITUTE, NATIONAL INSTITUTES OF HEALTH, U.S. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES; DR. 

THOMAS R. INSEL, DIRECTOR, NATIONAL INSTITUTE 

OF MENTAL HEALTH, NATIONAL INSTITUTES OF 

HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN 

SERVICES; AND WILLIAM FITZSIMMONS, EXECUTIVE 

OFFICER, NATIONAL INSTITUTE OF MENTAL HEALTH, 

NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT 

OF HEALTH AND HUMAN SERVICES 

 DR. AGWUNOBI. Thank you, Chairman Whitfield, Chairman Barton, 

and members of the subcommittee. Thank you for inviting me to testify 

at today’s hearing on management and disciplinary procedures of the 

Public Health Service Commissioned Corps. 

 My name is John Agwunobi and I am the Assistant Secretary for 

Health with the U.S. Department of Health and Human Services. As the 

Assistant Secretary for health, I serve as the Secretary’s primary advisor 

on matters involving the Nation’s public health and I oversee the U.S. 

Public Health Service Commissioned Corps. 

 The Corps is one of seven uniformed services of the United States. 

It is composed of more than 6,000 active-duty health professionals who 

serve at HHS and at other Federal agencies including the Bureau of 

Prisons, the Department of Homeland Security, the U.S. Coast Guard, 

and a number of others. The origins of the Corps may be traced back to 

the passage of an act in 1798 that provided for the care and relief of sick 

and injured merchant seaman. In the 1870s, the loose network of locally 

controlled hospitals was subsequently reorganized into the Marine 

Hospital Service. This name was changed in 1912 to the Public Health 

Service because it was noted that this force of dedicated individuals were 

taking on broader and broader responsibilities in pursuit of the public 

health of our Nation. 

 As America’s uniformed service of public health professionals, the 

Corps achieves its mission to protect, promote, and advance the health 

and safety of the Nation through rapid and effective response to the 

public health needs, leadership and excellence in public health practice, 

and the advancement of public health science. Now, the Corps today has 

a specialized career system. It is designed to attract, develop, and retain 

health professionals who may be assigned to Federal, State, or local 

agencies and indeed to some international agencies and organizations. 
318

The Corps has grown into one of the most significant public health assets 

in the world. In doing so, a tradition has evolved of a long and 

successful partnership with agencies where officers are employed. Corps 

members have served honorably and have been at the forefront of many 

of the advances in public health over this Nation’s history. Indeed, the 

Commissioned Corps was there at the beginning, the inception of the 

National Institutes of Health. Corps officers are expected to uphold the 

highest standards of ethical behavior both in their official roles and in 

their personal conduct. The Corps takes seriously any allegations of 

illegal infractions or other wrongdoings that bring discredit and dishonor 

to the Corps and to the Department of Health and Human Services. 

 Now, I have been invited to discuss with the subcommittee the 

subject of disciplinary and administrative actions that may be taken 

against Corps officers and the requirement and procedures applicable to 

the termination of an officer’s commission for misconduct. Misconduct 

by a Corps officer includes violation of any HHS standards of conduct 

regulations or of any other Federal regulation, law, or official 

government policy. The Corps has a variety of administrative and 

disciplinary actions that can be initiated to address officers who engage 

in misconduct. The decision as to which type of action to be applied is 

based upon the nature of infraction and the status of an officer. 

Generally, lesser offenses may be dealt with by the officer’s line 

supervisor in the agency of employment through letters of reproval or 

reprimand. When a potential offense is serious enough for a disciplinary 

action that affects the officer’s pay, rank, or employment, the matter is 

referred to the Corps for one of several possible board review processes. 

These included temporary promotion review boards, involuntary 

retirement boards, and boards of inquiry. A board of inquiry may be 

convened when an officer is charged by his or her supervisor with 

conduct constituting grounds for disciplinary action. Upon a finding of 

misconduct, a board may recommend the following action: termination 

of commission, which may include loss of retirement benefits and a 

reduction in rank or grade. All testimony before the board is given under 

oath or affirmation, and when the board has completed its deliberations, 

its recommendations are forwarded to me, the ASH, for final decisionmaking. 

 I will just conclude by saying that, sir, as you are aware, Secretary 

Leavitt is currently directing a major transformation of the 

Commissioned Corps. It is designed in part to allow us an opportunity to 

examine all of our policies and administrative systems and to ensure that 

they are robust, rigorous, and efficient in their implementation. I fully 

understand the gravity of the issues being explored by the subcommittee 

and I want to thank you again for inviting me to testify. I am ready to 
319

answer questions. I stand at your convenience to answer any questions 

you might have. 

 [The prepared statement of Hon. John Agwunobi follows:] 

PREPARED STATEMENT OF THE HON. JOHN AGWUNOBI, ASSISTANT SECRETARY FOR 

HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Introduction 

Chairman Whitfield and Members of the Subcommittee, thank you for inviting me 

to testify at today’s hearing on management and disciplinary procedures of the Public 

Health Service Commissioned Corps. 

 My name is John Agwunobi, and I am the Assistant Secretary for Health with the 

U.S. Department of Health and Human Services (HHS). As the Assistant Secretary for 

Health (ASH), I serve as the Secretary's primary advisor on matters involving the nation's 

public health and oversee the U.S. Public Health Service (PHS) for the Secretary. The 

PHS is comprised of agency divisions of HHS and the Commissioned Corps, a uniformed 

service of more than 6,000 active duty health professionals who serve at HHS and other 

federal agencies, including the Bureau of Prisons, the Department of Homeland Security, 

and the U.S. Coast Guard. The mission of the Commissioned Corps is: “Protect, 

promote, and advance the health and safety of the Nation.” I am the highest ranking 

member of the Commissioned Corps; I am a Regular Corps officer and hold the rank of 

Admiral. 

The Public Health Service 

 The origins of the Public Health Service (PHS), one of the seven uniformed services 

of the United States, may be traced to the passage of an act in 1798 that provided for the 

care and relief of sick and injured merchant seamen. In the 1870s, the loose network of 

locally controlled hospitals was reorganized into a centrally controlled Marine Hospital 

Service and the position of Supervising Surgeon, later becoming the Surgeon General of 

the United States, was created to administer the Service. The first Supervising Surgeon, 

Dr. John Maynard Woodworth, adopted a military model for his medical staff and created 

a cadre of mobile, career service physicians who could be assigned to areas of need. The 

uniformed services component of the Marine Hospital Service was formalized as the 

Commissioned Corps by legislation enacted by Congress in 1889. At first open only to 

physicians, over the course of the twentieth century, the Corps expanded to include 

dentists, dieticians, engineers, environmental health officers, health service officers, 

nurses, pharmacists, scientists, therapists, and veterinarians. 

 The scope of activities of the Marine Hospital Service also began to expand well 

beyond the care of merchant seamen in the closing decades of the nineteenth century, 

beginning with the control of infectious disease. As immigration increased dramatically 

in the late nineteenth century, the Marine Hospital Service was assigned the 

responsibility for the medical inspection of arriving immigrants at sites such as Ellis 

Island in New York. Because of the broadening responsibilities of the Service, its name 

was changed in 1912 to the Public Health Service. The Service continued to expand its 

public health activities as the Nation entered the twentieth century, with the 

Commissioned Corps leading the way. As the century progressed, PHS Commissioned 

Corps officers served their country by controlling the spread of contagious diseases such 

as yellow fever and smallpox (eventually assisting in the eradication of this disease from 

the world), conducting important biomedical research, regulating the food and drug 

supply, providing health care to underserved populations, supplying medical assistance in 

the aftermath of disasters, and in numerous other ways. 
320

 As America’s uniformed service of public health professionals, the Commissioned 

Corps achieves its mission to, “Protect, promote, and advance the health and safety of the 

Nation,” through rapid and effective response to public health needs, leadership and 

excellence in public health practices, and the advancement of public health science. The 

Corps today is a specialized career system designed to attract, develop, and retain health 

professionals who may be assigned to Federal, State or local agencies or international 

organizations. The PHS, with the Commissioned Corps at its center, has grown from a 

small collection of marine hospitals to one of the most significant public health programs 

in the world. In doing so, the tradition of a long and successful partnership has evolved 

with the agencies where officers are employed. Corps members have served honorably 

and been at the forefront of many of the advances in public health over this nation’s 

history. 

Disciplinary and Administrative Actions 

 I have been invited to discuss with the Subcommittee the subject of disciplinary and 

administrative actions that may be taken against Corps officers; and the requirements and 

procedures applicable to the termination of an officer’s commission for misconduct. 

 Corps officers are expected to uphold the highest standards of ethical behavior, both 

in their official roles and in their personal conduct. Commissioned Corps officers are on 

duty 24 hours a day, seven days a week, similar to our sister Services. The Corps takes 

seriously allegations of illegal infractions or other wrongdoing that brings discredit and 

dishonor to the Corps and the Department. We believe the Corps should strive for 

excellence of character and excellence in performance of duty, and we expect nothing 

less. When a determination is made that an officer has engaged in misconduct, he/she is 

subject to disciplinary action. 

 As a preliminary matter, I note that Commissioned Officers in the PHS and the 

National Oceanic and Atmospheric Administration (NOAA) are not generally under the 

purview of the Uniformed Code of Military Justice (UCMJ). Under the UCMJ 

jurisdictional statute, 10 U.S.C § 802, PHS and NOAA officers are subject to the UCMJ 

only when they are assigned to and serving with the armed forces. 

 If this jurisdictional prerequisite is not satisfied, cases of alleged misconduct 

involving individual Corps officers are solely handled in accordance with Commissioned 

Corps policies, as set forth in published Corps issuances. If there are potential criminal 

issues involved, these must be referred to the HHS Office of the Inspector General (OIG), 

which will coordinate with the Department of Justice for purposes of law enforcement 

investigation and prosecution. Non-criminal misconduct may be investigated by the 

agency operating division or by the Corps, depending on the situation. 

 Generally speaking, under Corps policy issuances, there are two broad categories of 

disciplinary administrative action available for uses in cases involving PHS 

Commissioned Corps officers: those actions not requiring a hearing – which include only 

a Letter of Reproval and a Letter of Reprimand – and those actions requiring a hearing – 

that is, all other administrative disciplinary actions up to and including termination of an 

officer’s commission. The nature of the hearing requirement may differ depending on the 

officer’s status (probationary vs. non-probationary, Reserve Corps vs. Regular Corps, 

etc.), as I will more fully describe in a moment. Moreover, involuntary termination of an 

officer’s commission results in the loss of all benefits otherwise associated with the 

officer’s uniformed services status. 

 How does the Corps define officer misconduct? Misconduct by a Regular or 

Reserve Corps officer includes violation of the HHS Standards of Conduct Regulations or 

of any other Federal regulation, law, or official Government policy. Such misconduct by 

an officer constitutes grounds for disciplinary or administrative action. 

 Some examples of officer misconduct include, but are not necessarily limited to: 

• Disobedience or negligence in obeying lawful orders of an official superior; 
321

• Absence from his/her assigned place of duty without authorized leave; 

• Unauthorized use or consumption of controlled substances or alcohol while on 

duty, being under the influence of such substances or alcohol while on duty, or 

illegally possessing, transferring, or ingesting controlled substances at any 

time; 

• Abusive treatment of subordinate officers, employees, patients or program 

beneficiaries, or of members of the public in their dealings with the 

Government; 

• Engaging in action or behavior of a dishonorable nature which reflects discredit 

upon the officer and/or PHS; 

• Submission of false information in an application for appointment or in any 

other official document; 

• Failure to observe generally accepted rules of conduct and the specific 

provisions of law and Standards of Conduct regulations; 

• Failure to comply with the Office of Government Ethics (OGE) regulations, 

Departmental supplemental and any other applicable standards of ethical 

conduct or regulations; 

• Failure to exercise informed judgment to avoid misconduct or conflict of 

interest; 

• Failure to consult supervisors or the Agency or Program’s Ethics Officer, when 

in doubt about any provision of regulations; or 

• Conviction of a felony. 

 Typically, administrative and disciplinary cases occurring within the Corps involve 

marginal or substandard performance, periods of being Absent Without Leave (AWOL), 

and cases of minor misconduct. The actual number of disciplinary cases is less than 1 

percent of the Corps’ active duty strength. In the past two years, there were 

approximately 100 disciplinary actions or pending actions that involved a total of 82 

officers. 

 The Corps has a variety of administrative and disciplinary actions that can be 

initiated to address officers who engage in misconduct. The decision as to which type of 

administrative or disciplinary action to be applied is based upon the nature of the 

infraction and the status of the officer. Lesser offenses may result in a Letter of 

Reproval, an administrative action generally taken by a supervisor, which does not 

become part of an officer’s personnel folder. More serious offenses can lead to the 

termination of an officer’s commission based on the recommendation of a Board of 

Inquiry or an Involuntary Termination Board. If a determination is made that an officer’s 

commission should be terminated, then the status of the officer determines what 

mechanism to be used and the level of due process that must be afforded to the officer in 

carrying out the action. For example, an officer who is on probation during their first 

three years on active duty may be summarily terminated upon 30 days notice with an 

opportunity to provide a written statement to the Director, Office of Commissioned Corps 

Operations. However, a Regular Corps officer or an officer who is eligible for retirement 

is afforded an opportunity to appear at a Board and present witnesses. 

 As a practical matter, disciplinary and administrative actions are enacted or 

recommended at the lowest level of the supervisory and administrative chain. Through 

delegation, the HHS Operating and Staff Division Heads, regional offices, the Surgeon 

General and Deputy Surgeon General, or the Director, Office of Commissioned Corps 

Operations (OCCO) have the authority to issue a letter of reproval or a letter of 

reprimand and to make recommendations to the Commissioned Corps regarding more 

serious disciplinary actions. 
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 To summarize, the disciplinary and administrative actions that may be taken against 

an officer may be grouped into two classifications, those actions not requiring Board 

review and recommendation and those disciplinary actions that require board review and 

recommendation. It is important to note, however, that even in cases that do not require 

Board review, the agency to which the officer is assigned works in consultation with the 

Commissioned Corps in developing a reasonable plan of disciplinary action. 

 Actions not requiring board review and recommendation are the following: 

• A Letter of Reproval, which is generally issued by the officer’s line supervisor. 

The letter is retained in the officer’s duty station personnel file and does not 

become part of the officer’s official personnel folder (OPF). 

• A Letter of Reprimand, which is generally issued by the line supervisor with 

the concurrence of the officer’s administrative chain of command. This letter 

becomes part of the officer’s OPF for a period of two years. While a Letter of 

Reprimand is within the officer’s OPF, he/she is not eligible for promotion, 

deployment, or to receive a PHS award. 

• Suspension from Duty is an administrative action recommended by the line 

supervisor with concurrence of the administrative chain of command. An 

officer may be placed in a non-duty with pay status pending resolution of 

disciplinary or administrative matters if such action is believed to be in the best 

interest of the Government. 

• Summary Termination is an action where the Corps terminates an officer’s 

commission without the review and recommendation of a board. Such action 

can be taken for officers who are AWOL for 30 or more consecutive days or 

those officers found guilty by a civil authority of one or more criminal offenses 

and having been sentenced to confinement for a period in excess of 30 days 

with or without suspension of probation. In addition, the commission of a 

Reserve Corps officer may be terminated during the first three years of his/her 

current tour of active duty – normally for substandard performance or 

misconduct. 

 The Commissioned Corps also has disciplinary actions that require board review and 

recommendation; they are the following: 

• Temporary Promotion Review Board (TPRB). This Board is appointed and 

convened by the Surgeon General to make recommendations about whether an 

officer should retain a temporary promotion based upon evidence that: an 

officer’s performance has deteriorated to an unsatisfactory level; an officer has 

engaged in misconduct; an officer is functioning at more than one grade below 

his/her temporary grade; an officer has failed to respond to progressive 

discipline; or an officer has failed to meet or maintain readiness standards, 

licensure requirements, and/or any other requirements set by the PHS 

Commissioned Corps. The ASH has the authority to revoke the temporary 

promotion of Regular and Reserve Corps officers based on a Board 

recommendation. 

• Involuntary Termination Board for Reserve Corps Officers (ITB). Except in 

the case of summary terminations, requests for involuntary termination of 

Reserve Corps officers are reviewed by an Involuntary Termination Board 

(ITB). An ITB may be convened for misconduct, substandard performance, 

and/or no suitable assignment. The ASH has the authority to terminate a 

Reserve Corps officer’s commission without the consent of the officer based on 

the recommendation of the Board. 

• Involuntary Retirement Board (IRB). An officer may be referred to an IRB 

after 19 years of creditable service by the Director, OCCO, based upon the 
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recommendation of the OPDIV/StaffDIV, Program Head or his/her designee to 

which the officer is assigned. The grounds to refer an officer to an IRB 

include, but are not limited to, substandard performance, conduct issues, 

falsification of official documents, or no suitable assignment. The IRB’s 

findings and recommendations, along with all documentation, are forwarded to 

the Surgeon General for approval or disapproval. The decision of the Surgeon 

General is based upon the IRB’s findings and recommendations, and any other 

relevant information in the record. A commissioned officer may be retired 

without the officer’s consent following the completion of 20 years of active 

service. 

• A Board of Inquiry (BOI) may be convened when an officer is charged by 

his/her superior or by any responsible person or persons with conduct 

constituting grounds for disciplinary action. Upon a finding of misconduct, a 

BOI may recommend the following actions: termination of commission and/or 

reduction in rank/grade. When a BOI recommends that an officer's 

commission be terminated and the ASH concurs, the ASH will then make a 

final decision as to the characterization of service based on the board’s 

recommendation, e.g., honorable, general (under honorable conditions), or 

other than honorable. 

 To explain a little more fully, a Board of Inquiry consists of at least three PHS 

commissioned officers, who are Commander or Captain in rank. A PHS 

representative(s), one or more PHS commissioned officers, is appointed to prepare the 

statement of charges and specifications against the officer and to act in the interest of the 

Government before the Board. The hearing is conducted by a Presiding Officer and the 

proceedings are not limited by formal rules of evidence, but do require reasonable 

standards of competency, relevancy, and materiality. All testimony before the BOI is 

given under oath or affirmation. When the BOI has completed its deliberations, its 

recommendations are forwarded to the ASH for final decision making. 

 The officer who is being charged does have the right to 30 days advance written 

notice, the opportunity to appear in person, with or without counsel, before the Board, 

and the opportunity to present witnesses before the BOI. 

 Particularly for the Board of Inquiry, when allegations brought forward against an 

officer include possible violations of the United States criminal code, the law requires the 

matter to be referred to the OIG. In such cases, we do not conduct any further 

proceedings, including any investigations, without the prior express concurrence of an 

authorized representative of OIG. We proceed only when it is determined that the Board 

of Inquiry will not pose any risk to criminal proceedings. 

 These are the disciplinary actions that can be taken by the Commissioned Corps in 

cases of misconduct by an officer. They are based in the policies and procedures that 

currently govern our Service. As you are aware, HHS Secretary Leavitt is directing a 

major transformation of the Corps. As part of this transformation, we are examining our 

policies and administrative systems to ensure they are robust and rigorous. We seek to 

ensure that our disciplinary approaches and procedures match those serious ethical 

questions that face us today and in the future. 

 In conclusion, I fully understand the gravity of the issues being explored by the 

Subcommittee and want to thank you again for inviting me to testify. I am ready to 

answer questions posed by the Subcommittee. 

 MR. WHITFIELD. Thank you, Mr. Secretary. 

 Dr. Kington, you are recognized for 5 minutes for your opening 

statement. 
324

 DR. KINGSTON. Thank you, Chairman Whitfield, Ranking Member 

Stupak, and members of the subcommittee. I am Raynard Kington. I am 

the Principal Deputy Director of the National Institutes of Health. I 

appear at your request today to testify about enforcement of ethics rules 

at the agency. 

 The mission of NIH is to advance biomedical and behavioral science 

to promote the health of the public. Part of achieving our mission 

requires working collaboratively with many parts of the private sector 

including colleges, universities, and research institutions across the 

country as well as private industry. Especially in our dealings with 

private industry, we always keep in mind the unique role we play in 

being guided always first by the requirement that we support science of 

the highest quality that will lead to improvements of health without 

consideration of personal or institutional profit. As the biomedical 

research enterprise of this country has grown in size and complexity over 

recent decades, the need for NIH to be seen both by the public at large 

and the scientific community as an unbiased source of scientific 

information has grown as well. We must be vigilant and adaptive in 

response to the evolution of the biomedical research enterprise so that 

that goal remains at the top of our priorities. 

 We were reminded of this responsibility in 2004 largely through the 

investigative work of this subcommittee when we learned that a small 

percentage of NIH scientists had taken undue advantage of or ignored 

Federal ethics rules that allowed them to engage in paid outside 

consulting with industry. As a result of these cases, the NIH and the 

Department of Health and Human Services working with the Office of 

the Government Ethics completely banned any paid consulting by NIH 

employees for the pharmaceutical and biotech industries. We took this 

action because even the suggestion of ethical lapses, apparent or real, in 

NIH programs would undermine public confidence in federally 

supported medical research and we could not allow this to happen. 

 In addition to these necessary ethics reforms, we disciplined 34 NIH 

intramural scientists who had violated ethics rules by failing to seek 

approval for or report consulting relationships with industry, failing to 

take annual leave while consulting, or consulting in areas that overlap 

with their official duties. These actions resulted from information 

provided through the subcommittee’s earlier investigation that identified 

81 NIH scientists who had allegedly consulted with industry but had not 

reported their consulting relationships to NIH as required. NIH 

investigated those individuals as well as 22 others either featured in the 

media or discovered when we asked our scientists to report any 

additional consulting that had not been reported to their supervisors. 

When violations were found, NIH implemented sanctions ranging from 
325

oral admonishment to suspension. In all cases where individual 

scientists failed to take leave to conduct outside activities, we ordered 

that the leave be paid back to the Government. In some cases, scientists 

returned honoraria that were inappropriately received, and in two serious 

cases, the NIH recommended that the employees be terminated. Every 

disciplinary action taken was guided by Federal personnel regulations 

and policies governing such matters which guarantee all employees 

access to due process, require the Government to consider several factors 

when recommending a particular discipline, and encourage the use of 

alternative forms of discipline. 

 The review of the 103 cases involves multiple components of the 

agency. The NIH Office of Management Assessment, NIH’s official 

liaison to the Office of the Inspector General, conducted reviews of all 

the cases, determining the facts and identifying the violations of our 

rules. The NIH ethics office was brought in to help assess whether 

specific ethics rules had been violated, particularly in matters involving 

potential overlap between official duties and private consulting. Under 

my direction, an expert panel of NIH Institute directors comprised of an 

objective group of Institute and Center directors, whose institutes did not 

have any cases, were convened to determine in each case where the 

employee had not received prior approval to engage in activity, whether 

the scientists’ outside activities overlapped with official duties. This step 

was taken because determining whether activities that had not received 

prior approval would have been approvable had procedures been 

followed was one relevant piece of information to be considered in 

determining penalties. Ten cases were referred to the Office of Inspector 

General for potential violations of criminal law. Upon completion of the 

reviews, the Office of Human Resources used existing policies to 

recommend appropriate penalties for those found to have violated the 

rules. 

 Two of the cases remain in the aftermath of our reviews. They 

involve NIH scientists who are also members of the Public Health 

Service’s Commissioned Corps. In each of these cases, we concluded 

that violations of Federal ethics rules were so egregious that they would 

have warranted proposed dismissal had the employee been part of the 

Civil Service. The cases were referred to the Corps because NIH cannot 

terminate the employment of Commissioned Corps officers. As Admiral 

Agwunobi noted, only the Corps itself after conducting a formal board of 

inquiry can dismiss officers in this circumstance. While these unique 

cases were pending before the Commissioned Corps and recognizing that 

each had not been formally adjudicated, NIH had to determine 

appropriate continuing duties for the scientists, each of whom remains an 

NIH employee. 
326

 It is important to note that neither the agency nor the Commissioned 

Corps anticipated at the outset that it would take as long as it has taken to 

resolve these cases. The employees involved are clinical investigators 

with responsibilities involving hundreds of patients and are leading 

researchers in important areas of public health concern. Their 

supervisors decided that the proper course of action should be 

determined by the needs of patients and the research while final 

decisions regarding employment were being determined. To the extent 

possible and under certain restrictions, we attempted to facilitate the 

needs of the patients and those important areas and research but only 

after it was clear that their continued involvement in no way harmed 

patients. Indeed, there was considerable concern about abruptly stopping 

their continued involvement as leaders of large clinical studies. In one of 

the studies where the employee’s actions continued to raise concern 

about his case, one of our institutes took further action, restricting his 

activities pending the outcome of the Commissioned Corps inquiry. 

 We also continue to address issues raised in the course of the 

committee’s investigation of the particular cases under discussion today. 

First, as NIH witnesses testified at the June 14 hearing, we are in the 

process of clarifying guidelines for NIH investigators so that they know 

which formal mechanisms are to be used to transfer human tissue 

samples to outside collaborators. In cases involving the transfer of 

material derived from human subjects, all written agreements must be 

accompanied by rigorous checks and balances including the review and 

approval by senior leadership at the relevant institute. Second, human 

subjects’ protection oversight at the NIH requires that use of all human 

subject samples be under continuing review of an institutional review 

board or overseen by the NIH Office of Human Subject Research and we 

are strengthening the system of oversight for continued review. Third, 

NIH is clarifying our policies regarding the presentation of scientific 

information to FDA advisory committees. NIH scientists may not appear 

at FDA committee meetings as representatives of outside companies. 

There may be, however, circumstances where it would be appropriate 

and beneficial to the public for a particular NIH scientist to appear at an 

FDA advisory committee meeting as part of his or her official duties. 

NIH is preparing a specific policy which will describe the circumstances 

in which such appearances are permissible. We will keep the 

subcommittee apprised of our progress as we implement these changes. 

 As a result of these investigations and reforms implemented by NIH, 

we believe that these cases are remnants of past policies. With new 

restrictions in place and a more efficient and rigorous ethics program 

underway, we are confident that the problems previously identified by 

this subcommittee are behind us. 
327

 Thank you for this opportunity to testify. I would be pleased to 

answer any questions members might have. Thank you. 

 [The prepared statement of Dr. Kington follows:] 

PREPARED STATEMENT OF DR. RAYNARD KINGSTON, DEPUTY DIRECTOR, NATIONAL 

INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Chairman Whitfield, Ranking Member Stupak and Members of the Subcommittee. I 

am Dr. Raynard Kington, Principal Deputy Director of the National Institutes of Health 

(NIH). I appear today at your request to testify about the enforcement of the Agency’s 

ethics rules. 

 NIH’s mission is to conduct research that will lead to better methods of diagnosing, 

treating, preventing, and curing disease. The research that we support has resulted in 

improvements in detecting disease, better therapies, and more effective vaccines. 

 The United States leads the world in biomedical research. We have achieved and 

maintained our preeminent status by balancing a massive public and private sector 

partnership. The programs of NIH are supported by appropriated funds, whereas the 

pharmaceutical and biotechnology industries finance their research from revenues or the 

promise of profits. Nevertheless, the translation of research from the bench to the 

bedside cannot occur without collaborations between publicly-supported researchers and 

industry scientists. While some work in government and others operate in industry 

facilities, they undergo similar training, and their methods are often indistinguishable. 

 Most biomedical research, whether funded by the public or private sector, is 

conducted at non-government facilities. An exception to that is the NIH intramural 

program, where research is conducted in federal facilities by government scientists, 

although this intramural research represents only ten percent of NIH’s overall budget. 

 It is expected that those at NIH entrusted with Federal funds are faithful stewards of 

the public trust. This clearly means that NIH-funded research must be free of bias and 

the influence of profit incentives. To this end, NIH and the Department of Health and 

Human Services (HHS), working with the Office of Government Ethics, banned any 

paid-consulting for NIH employees with the pharmaceutical and biotechnology 

industries. 

 We took this action because even the suggestion of ethical lapses, apparent or real, 

in NIH programs would undermine public confidence in federally-supported medical 

research. We could not allow this to happen. 

 In addition to these ethics reforms, we disciplined 34 NIH intramural scientists who 

had violated the previous ethics rules by failing to seek approval for -- or even report -- 

consulting relationships with industry, by failing to take annual leave while consulting, or 

by consulting in areas that overlapped with their official duties. These actions were taken 

because information provided through the Subcommittee’s earlier investigation had 

identified NIH scientists who consulted for industry but had not reported their consulting 

relationships to NIH. NIH investigated these individuals, as well as other individuals 

whose cases were discovered when we asked our scientists to report any undisclosed 

consulting to their supervisors. When violations were found, NIH implemented sanctions 

ranging from oral admonishments to letters of reprimand to suspensions. In all cases 

where individual scientists failed to take leave to conduct outside activities, they were 

directed to pay back that leave to the government. In many cases, scientists returned 

honoraria that were inappropriately received. 

 The review of these cases involved multiple components of NIH. The Office of 

Management Assessment (OMA), NIH’s official liaison to the HHS Office of the 

Inspector General (OIG), conducted reviews of all the cases, determining the facts and 

identifying violations of rules. My office convened an expert panel of NIH Institute 
328

Directors, whose Institutes did not have any cases, to determine whether the scientists’ 

outside activities overlapped with official duties. The NIH ethics office gave technical 

advice and administrative support to this panel. Ten cases were referred to the OIG due 

to potential violations of criminal law. Upon completion of the reviews, the Office of 

Human Resources used existing policies to identify appropriate penalties for those found 

in violation of the rules. 

 Two of the cases identified in the internal review are still active. They involve NIH 

scientists who are also members of the Public Health Service Commissioned Corps 

(Corps). In each of the cases, NIH concluded that the facts were sufficiently egregious to 

warrant referral to the Corps, which has independent authority to investigate the facts and 

the latitude to determine the most appropriate level of discipline for its commissioned 

officers through the Board of Inquiry process. 

 We also continue to address issues raised in the course of the Committee’s 

investigation of the particular cases under discussion today. First, as NIH witnesses 

testified at this Subcommittee’s June 14, 2006, hearing, we are in the process of 

clarifying guidelines for NIH investigators to inform them which formal mechanisms are 

to be used to transfer human tissue samples to outside collaborators. In cases involving 

the transfer of material derived from human subjects, all written agreements must be 

accompanied by rigorous checks and balances, including the review and approval by 

senior leadership at the relevant Institute. Second, the use of samples or data of human 

subjects, as HHS regulations prescribe, is overseen by an Institutional Review Board or 

by the NIH Office of Human Subjects of Research. Third, NIH is clarifying its policies 

regarding the presentation of scientific information to Advisory Committees at the Food 

and Drug Administration (FDA). NIH scientists may not appear at FDA Advisory 

Committee meetings as representatives of outside companies. There may, however, be 

circumstances where it would be both appropriate and beneficial for a particular NIH 

scientist to appear at an FDA Advisory Committee meeting as part of his or her official 

duties. NIH is preparing a specific policy which will describe the circumstances in which 

such appearances are permissible. We will keep the Subcommittee apprised of our 

progress as we implement these changes. 

 As a result of these investigations and reforms implemented by NIH, cases such as 

those being discussed today are hopefully remnants of past policies. With new 

restrictions in place and a more efficient and rigorous ethics program underway, we are 

confident that the problems previously identified by this Subcommittee are behind us. 

 Thank you for the opportunity to testify. I will be pleased to answer any questions 

Members of the Subcommittee may have. 

 MR. WHITFIELD. Thank you, Dr. Kington. 

 Now, it is my understanding that Dr. Niederhuber, Dr. Insel, and Mr. 

Fitzsimmons do not have any opening statement but are here simply to 

answer questions. Is that correct? 

 DR. NIEDERHUBER. That is correct. 

 MR. WHITFIELD. All right. We have three votes on the House floor. 

We have about 4 minutes left in the first vote and then there will be two 

5-minute votes. So we will recess the hearing until we go cast these 

votes, and I would expect we will be back here before 2:00. So you all 

relax and we will be back in a few minutes. Thank you. 

 [Recess] 

 MR. WHITFIELD. The hearing will reconvene, and Chairman Barton 

has another hearing that he is going to be involved in so I am going to 
329

recognize him for the first round of questions. Chairman Barton is 

recognized for 10 minutes. 

 CHAIRMAN BARTON. Thank you, Mr. Chairman, and I thank 

Ranking Member Stupak for allowing me to go out of turn. I am not real 

sure exactly who these questions should be referred to, whether they 

should be Mr. Agwunobi or Mr. Kington or Dr. Insel, so I am going to 

ask the question and then whichever person appears appropriate should 

answer it. 

 My concern, the thrust of my question is going to be, we have an 

employee, Dr. Sunderland, who has been recommended for termination, 

who offered to resign subject to certain conditions, and that resignation 

was not accepted, who testified before this subcommittee and took his 

constitutional privilege against self-incrimination under the Fifth 

Amendment and yet he is still on the payroll, going to work and doing 

things that would appear to be inappropriate. Let me give you an 

example. He was recommended for termination by Dr. Insel. The 

following week was approved apparently for a travel request to go to 

Denmark. Now, that was revoked after the committee staff questioned 

that. All in all, he has apparently though been approved for travel five 

times since he was recommended that he be terminated and one of those 

was a trip to Hawaii. In addition, he has been approved for somewhere 

between $20,000 and $95,000 in compensation and various expenses 

since his recommendation for termination. There has yet to be a court of 

inquiry so we have an individual here who everybody appears to 

acknowledge at least appears to have repeatedly violated some of the 

ethical rules at NIH and yet he is still on active duty, fully funded, and 

the NIH is even helping to pay to move some of his equipment and 

personal belongings to New York. Why in the world is that going on? 

Who wants to take an attempt to answer that? 

 DR. AGWUNOBI. Thank you, Mr. Chairman. If I may, I will try to 

talk to the active-duty part of this and then I will defer to my NIH 

colleagues to speak to the NIH-specific aspects of your question. 

 In situations where a Commissioned Corps officer is alleged to have 

had or to have participated in serious misconduct, the rules and 

requirements of the Commissioned Corps require that that individual, in 

the situation, the facts and the premise be inquired into and investigated 

by a board of inquiry. That board of inquiry makes a determination as to 

whether or not the facts, the evidence, statements from witnesses, 

whether or not in their minds this board of typically three to five 

Commissioned Corps officers and others, they make a determination as 

to whether or not they believe a recommendation needs to be made that 

the individual be terminated. Now, I would add that a similar 

circumstance would happen if-- 
330

 CHAIRMAN BARTON. But you have not conducted that board yet. 

 DR. AGWUNOBI. That is correct, sir. 

 CHAIRMAN BARTON. And it is not even scheduled. 

 DR. AGWUNOBI. Sir, the board of inquiry was actually ordered by 

the Surgeon General at the time, Richard Carmona. This was done 

shortly after the allegation was formally brought to the Corps. That 

board of inquiry was subsequently suspended by the Surgeon General, 

that order was suspended because of a request that we received from the 

Department of Justice. They informed us that a criminal inquiry was 

underway and that they required us to stand down, stand to one side, 

suspend our activities so that they could pursue the criminal 

investigation. 

 CHAIRMAN BARTON. What if that takes 15 years? How long are 

you going to--I mean, look, I respect the Department of Justice but that 

shouldn’t preclude the Commissioned Corps from doing its duty. You 

have got an individual in our service that has been accused and there 

appears to be more than adequate evidence, it is evidence enough that it 

has been recommended he be terminated, and yet he is going on trips to 

Hawaii. We are paying to move his personal effects to New York. 

 DR. AGWUNOBI. Yes, Mr. Chairman. 

 CHAIRMAN BARTON. I do not understand that. 

 DR. AGWUNOBI. As it relates to the board of inquiry, that is a 

process that will determine what kind of discipline needs to occur, and 

there is only one reason why that board of inquiry hasn’t finished its 

work. The only reason is because at the request of the Department of 

Justice and in pursuit of justice-- 

 CHAIRMAN BARTON. Well, where are you going to conduct this 

court of inquiry? 

 DR. AGWUNOBI. It is a standing policy within our organization, it is 

long adhered to within the uniformed service, the Commissioned Corps, 

and I would add-- 

 CHAIRMAN BARTON. Why would it not be appropriate to go ahead 

and conduct the court of inquiry? Let us assume you exonerate the man. 

Then that helps him with the DOI and Department of Justice 

investigation. On the other hand, let us assume that you convict him or 

find him--I don’t know what the correct legal term is, but find that he is 

actually guilty of the allegations. Then that would be a plus in the 

investigation of DOJ. 

 DR. AGWUNOBI. My understanding-- 

 CHAIRMAN BARTON. I don’t understand why you--I can’t think of a 

good analogy in the Congress that would apply but in any event, why in 

the world is he being approved for travel? Why in the world is he going 

on travel? Why in the world is he having the NIH staff help him package 
331

and send NIH materials and his personal effects to his next place of 

employment? 

 DR. KINGSTON. Sir, let me respond initially and then Dr. Insel can 

respond as well. The decisions regarding his day-to-day work 

assignments by practice was handled by his immediate supervisors at the 

Institute but it is important to remember a couple points here. First of all, 

none of us, neither the Commissioned Corps nor the agency ever 

anticipated it would take this long to resolve the matter, and the 

expectation was that it would be resolved more quickly. In the interim, 

there was a balancing decision made about how much he should be 

allowed to do because we did not have the authority without this board of 

inquiry to terminate him, and a decision was made-- 

 CHAIRMAN BARTON. Why is that? 

 DR. KINGSTON. Because those are the rules, the way the-- 

 CHAIRMAN BARTON. The only way you can terminate an individual 

is if they have been convicted of some gross crime or something? 

 DR. KINGSTON. For commissioned officers, there is the policy that 

Admiral Agwunobi just described and this is the way the policies are set 

up, that we may not terminate an officer in that position independently. 

 CHAIRMAN BARTON. So as long as he can drag this out, he is a free 

agent? He can do whatever he wants to do and the NIH management is 

just going to make sure that his pay voucher is there? 

 DR. KINGSTON. We can take actions in terms of supervising but we 

can’t terminate, and maybe Dr. Insel could comment on the-- 

 CHAIRMAN BARTON. What if he just stopped coming to work? 

What if he just said the hell with it, I am not--then could you terminate 

him? 

 DR. AGWUNOBI. Sir, our rules say that if you are away without 

leave, AWOL, for more than 30 consecutive days, that is reason for 

summary termination, even without a board. We have pretty clear rules 

on when is an individual referred to a board and when can they be 

summarily terminated. In that situation, that would apply. 

 CHAIRMAN BARTON. What if he came one day a month, every 25th

day? 

 DR. AGWUNOBI. Sir, if there was a-- 

 CHAIRMAN BARTON. I mean, he is not doing--let us be a little bit 

positive. He is showing up. Apparently he is trying to work, so I guess 

he should be commended for that, but-- 

 DR. AGWUNOBI. Sir, in any circumstance where his supervisor 

believes that there is misconduct that requires action that could affect the 

person’s commission, rank, retirement, these are all situations that would 

require us to use a board of inquiry to inquire into the facts, make a 

determination and a-- 
332

 CHAIRMAN BARTON. That would be nice if you had held a board of 

inquiry. Now, Dr. Insel, my briefing says that you recommended that he 

be terminated. Is that correct? 

 DR. INSEL. That is correct. I think it was November 21, 2005. 

 CHAIRMAN BARTON. Okay. Now, do you think it is appropriate 

since you recommended his termination that he still be allowed to 

basically continue his activities as he sees fit? 

 DR. INSEL. Well, the first point in your opening statement, you said 

that you thought it was absurd that he is still working for us, and I think 

that may have been kind. I think this is, as I told you in June, well 

beyond the time that any of us would have liked to have seen this 

resolved, and it is not clear, as you are pointing out, that the end is in 

sight even now. 

 CHAIRMAN BARTON. If he were not in the Commissioned Corps, 

would you have more ability to terminate him? 

 DR. INSEL. Yes. 

 CHAIRMAN BARTON. So the fact that he is part of the Commissioned 

Corps makes it more difficult? 

 DR. INSEL. It takes-- 

 CHAIRMAN BARTON. Does it make it impossible? 

 DR. INSEL. It takes it out of my hands. Were he in the Civil Service, 

I believe he would have been gone before the end of 2005. 

 CHAIRMAN BARTON. But why has he not been restricted? I mean, it 

is bad enough that he hasn’t been terminated but why hasn’t he been 

restricted in his activities and prevented from having access to apparently 

all of his equipment and office materials and things like that? 

 DR. INSEL. So he has been restricted in a number of ways but that 

has been iterative, and in retrospect, we should have some of that earlier. 

Had we known this was going to take so long and had we known the 

extent of violations, some of which we are only finding out about how, 

we would have done more much earlier. What we were doing 

throughout though was, we recognized that there was a difference 

between the outside activities which were the source of the violations 

and all of the concerns about his ethical behavior and his official duty 

activities. Official duty had to do with what the studies were that he was 

involved with, how he behaved while he was at work. We don’t have 

here a record of him harming patients. We don’t have here a record of an 

integrity, a research problem. This is about outside activities and those 

were greatly restricted very early on. In terms of the official-duty piece, 

you asked before about why would he be allowed to go to a meeting. 

Well, this was part of his job. He represented the Institute in terms of 

work that he did. 
333

 CHAIRMAN BARTON. Well, if he has been recommended for 

termination, I would think if you can’t fire the man, you could at least 

put him on leave without pay, and if you can’t put him on leave without 

pay, you could at least restrict him to showing up at the office and doing 

some routine work that doesn’t impact the outside world in any way. 

 DR. INSEL. So let us go through the options because we have talked 

about this right along. It has been a concern about what we actually 

could do in this situation, and I must say, to some extent this is frontier 

territory. We haven’t been in this situation before. Leave without pay 

we were told was not an option. 

 CHAIRMAN BARTON. Why is that? 

 DR. INSEL. I might refer that to-- 

 CHAIRMAN BARTON. I apologize for my time expiring. But if we 

could just finish this before I have to turn it back over. 

 DR. AGWUNOBI. Mr. Chairman, I would just start by restating, there 

is only one reason why a board of inquiry hasn’t sat and met on the 

individual that you identified and that is because the Department of 

Justice has asked us to hold while they conduct a criminal investigation. 

Leave without pay is a disciplinary intervention. It would require that 

this individual go before a board of inquiry and that that board of inquiry 

determine what the intervention needed to be before it could be 

recommended. That process would have occurred once again if it 

weren’t for the fact that the Department of Justice is conducting an 

ongoing criminal investigation and has asked us to hold-- 

 CHAIRMAN BARTON. Well, I predict, if you don’t do the board of 

inquiry, the Department of Justice will take at least another 2 years, and 

he is still going to be on the payroll. If you hang your hat on waiting for 

the Department of Justice, and I am not down on the Department of 

Justice but, they do not operate on the same timetable. You have got 

somebody that has been recommended for termination. Since then he 

has gone on at least one trip to Hawaii and yet you are still sitting here 

telling us you don’t even have a time for it. You don’t even have a time 

for it. I mean, I understand due process and I respect the rights of the 

accused to have the ability to face their peers and all this but that doesn’t 

mean they can hide under bureaucracy for years and years and years, and 

that is what is happening. Now, the Department of Justice can request 

that you do something, but that does not prevent you from doing your 

duty and your duty is not to let this individual continue to operate 

apparently without any penalty for what appears to be serious violations 

of the ethical rules of the NIH. 

 Mr. Chairman, I have abused the privilege. I apologize for that, and 

I yield back. 
334

 MR. WHITFIELD. At this time I recognize Mr. Stupak of Michigan 

for 10 minutes. 

 MR. STUPAK. Thank you, Mr. Chairman. Dr. Insel, let me just 

follow up where the Chairman left off. If he is an employee of NIH but 

really a Corps employee, why not just send him back to the Corps and 

not even have him at NIH anymore? Doesn’t it really cause the other 

people at NIH who are trying to do their jobs, doesn’t it look sort of odd 

to them to have this person who is under this cloud of suspicion for so 

long who you recommended for termination to still be there doing 

functions? Why not just send him back? You can send him back, can’t 

you? 

 DR. INSEL. Well, that is a good question and one that I am not sure I 

have the full answer for. We have looked at a lot of options and there 

have been meetings with senior NIH management and-- 

 MR. STUPAK. Well, can’t you send him back? 

 DR. INSEL. So since he is effectively detailed to us, the question had 

been raised about-- 

 MR. STUPAK. Well, is there an end date of this detail? Does he have 

to be there for so many years? Isn’t it really at your discretion? 

 DR. INSEL. No, I think it is at the Corps’ discretion as to where the 

detail takes place as far as-- 

 MR. STUPAK. So as director of NIH, you don’t have any say on who 

gets detailed to you? 

 DR. INSEL. Well, not when someone has been there for a while. I 

can ask my colleagues to the right. I actually don’t know that there has 

been an instance of changing the detail in this kind of a case but-- 

 DR. KINGSTON. That was--we had lengthy discussions with the 

various specialists in actions we could take and in numerous discussions, 

that was never raised as something that we were allowed to do. 

 MR. STUPAK. Okay. I am raising it now. Can you send him back? 

 DR. KINGSTON. Well, we would have to ask the authorities to see 

whether we could. 

 MR. STUPAK. I mean, I find it rather appalling. You are sitting there 

saying he is going to these meetings representing NIH under this dark 

cloud that everybody knows about. What the heck kind of signal does 

that send everybody else? I mean, I would think someone would go out 

and take the bull by the horns and do something here. It has been 4 years 

since we brought this your attention. Four years. We are still going 

round and round. He represents the NIH, is under a cloud of suspicion. 

He has got criminal investigations going on. Gentlemen, someone has 

got to accept some responsibility and do something here. 

 DR. AGWUNOBI. Sir, the particular case that you described, it is my 

understanding it was first referred to the Commissioned Corps in 
335

December of 2005 for action. We have been in dialog with the 

leadership of NIH since then as partners-- 

 MR. STUPAK. Eleven months, haven’t been able to make a decision. 

 DR. AGWUNOBI. Well, actually a decision was made within 60 days. 

A decision was made to hold a board of inquiry. We-- 

 MR. STUPAK. But my question was, why not just send him back to 

the Corps? 

 DR. AGWUNOBI. As I say, sir, the conversation, the partnership 

between us and the agency decided that the best approach to handling 

this circumstance was a board of inquiry. Once again, the only reason 

why that board of inquiry-- 

 MR. STUPAK. Right. I understand. Okay. I don’t want to use up my 

whole time going over--how about Mr. Walsh? There is no board of 

inquiry on him, is there? 

 DR. AGWUNOBI. I believe there is. A board of inquiry has been 

ordered. 

 MR. STUPAK. As of like a couple days ago you just started it? 

 DR. AGWUNOBI. Within the last week, sir. 

 MR. STUPAK. Yeah, so he sat in limbo for 9 months from January of 

2005 until September 7, so for 9 months he wasn’t under a board of 

inquiry once again and he is not a Corps person, right? 

 DR. AGWUNOBI. No-- 

 MR. STUPAK. Oh, he is? 

 DR. AGWUNOBI. Yes, sir. 

 MR. STUPAK. So why was no decision made on him then, Mr. 

Walsh? 

 DR. AGWUNOBI. A decision was made when the board of inquiry 

was ordered for Dr. Sunderland that we would hold the board of inquiry 

for Walsh upon completion of the board for Sunderland. 

 MR. STUPAK. So he sat for 9 months not knowing whether or not 

there would be one? 

 DR. AGWUNOBI. A board of inquiry hasn’t sat on him yet, sir. 

 MR. STUPAK. Okay. Mr. Kington, if I may--Dr. Kington. Go to 

Exhibit #3 because I was looking at this spreadsheet produced by the 

Office of Management Assessment and it is entitled Results of 103 

Individuals’ Reviews by NIH Human Capital Group, Exhibit #3. Some 

of these findings and subsequent actions are simply astounding. An 

investigator named J. Gade, if I am saying that right, was found to have 

received almost half a million dollars, $500,000 without prior approval 

and was given a 45-day suspension. So Mr. Gade is an investigator. 

How much money would he make a day? 

 DR. KINGSTON. Actually, I am not--I don’t know what his salary is. 
336

 MR. STUPAK. Well, with a 45-day suspension, that comes out to 

$11,000 per day. Did he have to pay back the half-million dollars? 

 DR. KINGSTON. I am not aware that he returned the payments. 

 MR. STUPAK. So therefore if I am making maybe $1,000 a day and I 

am sure that is more than generous of what he makes, I am $10,000 

ahead because I don’t have to pay anything back, so where is the 

deterrent in this kind of activity? 

 DR. KINGSTON. First of all, it was unprecedented for us to suspend 

without pay an NIH scientist. No one in the entire administration of the 

agency had ever had a case even remotely close to suspending an 

employee for 9 weeks of pay, especially for a senior scientist, so it was a 

significant penalty and all of--every step of the way, every step of the 

way we obeyed Federal personnel rules and regulations that-- 

 MR. STUPAK. Come on. You can’t tell me Federal rules say you can 

accept improper $500,000-- 

 DR. KINGSTON. You are right, and-- 

 MR. STUPAK. --and you can keep your job, you get a 45-day 

suspension, you don’t have to pay it back and everybody is happy. 

 DR. KINGSTON. This was a significant penalty. We-- 

 MR. STUPAK. Forty-five days? Come on. This is a half-million 

dollars. 

 DR. KINGSTON. Nine weeks of leave without pay, it is 

unprecedented for an NIH scientist to have received-- 

 MR. STUPAK. So then what does it take for an NIH person to be 

terminated? If a half a million dollars won’t do it, what does it take? 

 DR. INSEL. Can I add to that? 

 MR. STUPAK. Sure. 

 DR. INSEL. I think the answer to your question is conflict. This was 

a case in which it was determined as far as I can understand, and Dr. 

Kington can give you more information about this, but there was no 

inherent conflict of interest. All the activities, though they were highly 

paid, were considered to have been approvable, but they were not 

disclosed. 

 MR. STUPAK. So if it would have been approved, he could have kept 

the half-million dollars? 

 DR. INSEL. Had they been approved, had they been disclosed, we 

wouldn’t be talking about this. 

 MR. STUPAK. Do you have scientists who receive half a million 

dollars in outside activities that is approved? 

 DR. INSEL. In 2006, that is no longer possible, but-- 

 MR. STUPAK. No, back then, before this, 2005-- 

 DR. INSEL. Not even in 2005. 
337

 MR. STUPAK. Okay. Explain this one to me. How about Steven 

Katz, director of NIAMS, received about $275,000 but no action was 

taken because the employee, and I quote now from Title III, “remedied 

the violation.” What does that mean? How do you remedy a violation? 

 DR. KINGSTON. First of all, let me respond. These reviews were 

handled centrally by the NIH Office of Management Assessment. We 

followed standard GAO rules and regulations and it was determined-- 

 MR. STUPAK. Excuse me, Doctor. I only have a limited time. 

 DR. KINGSTON. It was determined that-- 

 MR. STUPAK. So what does “remedied the violation” mean? 

 DR. KINGSTON. It was determined that it was not a significant 

violation, and I was intentionally, as were all of the senior leadership, 

kept away from specifics because we might be appeal officials later on 

and if we had been involved-- 

 MR. STUPAK. That is fine, but just-- 

 DR. KINGSTON. --it would have been prejudice. 

 MR. STUPAK. Well, what does “remedied the violation,” what does 

it mean? He paid it back? 

 DR. KINGSTON. There was some type of compensation and that it 

was determined that it was not severe enough to warrant any type of 

significant intervention, and that was true. That case was reviewed at 

length, and Dr. Katz was not found to have-- 

 MR. STUPAK. Well, there are others here, between $40,000 and 

$60,000, and you have things like oral admonishment. 

 DR. KINGSTON. There were a number of factors taken into 

consideration. Those factors are guided by law, and we-- 

 MR. STUPAK. You know, every one of us Members up here, I bet 

you, receive at least once a year a letter in the mail and there is always a 

dollar bill stapled at the top of it and it is like I am paying you a dollar to 

answer my letter. Okay. We send the dollar back. You know what 

would happen if any one of us took a dollar for answering a piece of 

mail? We would all be out the door. And why? Because of ethics and 

integrity and no blemish on it. You are blemishing the Corps. You are 

blemishing the NIH. And these are just, oh, give him an oral 

admonishment. That doesn’t fly. 

 DR. KINGSTON. There is a system that determines the factors that are 

taken into consideration for any type of penalty. Every step of the way 

we assure that any action that we took fit within the Federal rules and 

regulations about what penalties were taken and every step of the way we 

followed Federal rules and regulations and laws that determine what 

factors are considered when taking disciplinary action against an 

employee. 
338

 MR. STUPAK. I will bet you there is no Federal rule or regulation 

that says half a million dollars, you get 45 days off, $275-- 

 DR. KINGSTON. That is correct, because the rules are more complex 

than that. 

 MR. STUPAK. And it is your interpretation and it is your application 

of those rules and regulations? 

 DR. KINGSTON. We believe that we applied those rules rigorously 

and consistently across the cases and consistent with how any other 

disciplinary action was-- 

 MR. STUPAK. Consistent with what? What did you review it with? 

You said you never had these problems before. So where is your 

consistency? Where is your parallel? How did you make that 

determination? 

 DR. KINGSTON. That is a fair question. 

 MR. STUPAK. What is your baseline? 

 DR. KINGSTON. That is a fair question. What we did is, in the 

process of determining what range of interventions were appropriate for 

any specific case, we consulted the specialists who handle employee 

disciplinary action at the agency for any type of disciplinary action and 

we in each case had that specialist determine the range that the violation 

fit into in terms of disciplinary action compared to all the other 

disciplinary actions that the agency has taken, and in every case, we have 

complied with the recommendations of those specialists who specifically 

asked that question. We asked that question. 

 MR. STUPAK. Are the specialists within the Federal government or 

private? 

 DR. KINGSTON. No, the specialists are Federal employees who 

specialize in determining what are the appropriate disciplinary actions 

for any specific case, and in every single case we followed Federal rules 

to the letter. 

 MR. STUPAK. I am glad those guys aren’t on the sentencing 

guidelines, let me tell you. 

 Dr. Insel, is it true that the Alzheimer’s study that we spent so much 

time on that Dr. Sunderland did, has that been discarded now? Is anyone 

going to further try to look for biomarkers to try for early detection? Has 

that study been abandoned? 

 DR. INSEL. The study isn’t abandoned. There is a--what I think you 

are referring to is called the BIOCARD study, biomarkers in elder 

controls at risk for dementia. That study is an NIH study. It still has an 

ongoing and continuing protocol, but it is closed at NIH for new accrual 

of patients. 

 MR. STUPAK. But the study is still going on? 
339

 DR. INSEL. The study is not going on currently. It is a longitudinal 

study and so we are in a suspended state here. 

 MR. STUPAK. So in other words, there is no funding going into it? 

 DR. INSEL. There is no funding going into it. 

 MR. STUPAK. Why don’t you get back all the money these people 

took for consulting, put it back in there and fund the study, because it is a 

program that Congress feels very strongly about. So now you have bad 

apples, now we suspend the study because we can’t fund it, so why don’t 

we just take these fines and costs--not fines and costs, I am sorry--these 

consulting fees and put it back in? 

 DR. INSEL. So can I clarify what we mean by suspension? 

 MR. STUPAK. Sure. 

 DR. INSEL. This is a longitudinal study. The hope would be that it 

would go for 20 to 30 years. We are in I think the 11th year of this study. 

 MR. STUPAK. Right. 

 DR. INSEL. Right now there have been no new patients entered in I 

believe since January of 2005 at NIH. The NIMH itself is not likely to 

want to continue to bring in new patients for the study because we are 

shifting and going in other directions. 

 MR. STUPAK. But you still have the research and things like this on 

this study, right, on the subjects you already have entered into the study? 

 DR. INSEL. Will there be additional research? 

 MR. STUPAK. Yes. 

 DR. INSEL. The hope would be that we will find a way to keep this 

going but it doesn’t mean that necessarily NIMH has to-- 

 MR. STUPAK. Well, why can’t you keep it going? Is it money or 

you don’t want to have further studies or persons come into it? 

 DR. INSEL. Well, it is a combination of things. I think the study is 

meritorious. I think it is worth doing. It is outside of our core mission. 

We would like to use our funds for-- 

 MR. STUPAK. Well, why did you start it if it is outside your core 

mission and after spending millions of dollars for almost 2 decades? 

 DR. INSEL. That is a good question. 

 MR. STUPAK. Or 11 years. 

 DR. INSEL. The intramural program, which is the part of our agency 

here in Bethesda where we have got lots of exciting things going on 

occasionally does do projects such as this one that aren’t that closely 

connected to the Corps. I came in and decided that I wanted us to be 

much more mission-focused and so as the leader of the agency decided 

that this was-- 

 MR. STUPAK. Who is going to do the research then on Alzheimer’s 

if you are not doing it? 
340

 DR. INSEL. Well, we have two other agencies within NIH, the 

National Institute of Aging and the National Institute of Neurological 

Diseases. They spend collectively about $656 million on Alzheimer’s. 

So this study is a very, very small piece, but it is the clinical research on 

Alzheimer’s in Bethesda in the intramural program. 

 MR. STUPAK. Sure, trying to determine the biomarkers. Thank you. 

 MR. WHITFIELD. Thank you, Mr. Stupak. 

 I think all of us recognize the NIH is the national leader and the 

premier obviously government agency in research and development 

looking for cures of all sorts of diseases and maladies. I think all of us 

also recognize the importance as Dr. Insel said the last time he was here 

of setting the high standards, and in your testimony, Dr. Kington, you 

talked about how after you all started looking into this, you had 52 

violations. You disciplined 34 scientists. You referred 10 cases to 

appropriate officials for possible violations of criminal laws. That is for 

an institution that has the reputation that NIH has and how that sort of 

all-encompassing disclosure of ethical violations and--it is sort of 

disturbing. Are any of you disturbed about it or concerned about it or are 

we making more of it than should be made of it? 

 DR. KINGSTON. Not at all. We were all deeply concerned about the 

reputation of the agency and our ability to accomplish our mission, 

which is why we aggressively responded. We worked closely with the 

department and the Office of Government Ethics to pass regulations that 

now preclude any outside consulting with industry. We aggressively 

pursued the cases. We have greatly expanded our ethics program so that 

we feel confident that we are building a program that will be the best in 

the Federal government. We have responded quite aggressively because 

we were appalled that we had a system that didn’t appear to be working 

as well as it could have. 

 MR. WHITFIELD. Now, had you ever had anything at this scale 

before of violations of NIH ethics rules-- 

 DR. KINGSTON. I asked that question, and I was told no. 

 MR. WHITFIELD. So the largest scandal, if we can call it that, in 

NIH’s existence then? 

 DR. KINGSTON. And we certainly hope it will be the last. 

 MR. WHITFIELD. Now, I think-- 

 DR. INSEL. I am sorry, if I could add to that. I think when you see a 

list like this though, one way to understand it is, that it is not as if we 

suddenly collected a number of people who had ethical dilemmas. What 

was happening here was that there was a systemic problem to some 

extent. We weren’t doing the job we needed to do to make the rules 

clear and to make sure people could follow them, and so the scandal 

came about as a way of forcing all of that to change. 
341

 MR. WHITFIELD. Now, I am not going to be an apologist for NIH, 

but you are dealing with some particularly skilled people here. These 

scientists are involved in very important research and I am assuming that 

salaries paid by the Commissioned Corps and NIH generally may not be 

as high as in the private sector. I am also assuming that they allowed 

these consulting agreements on the side as a way of subsidizing salaries. 

Would that be correct? 

 DR. KINGSTON. It was an allowable way, but it is also important to 

remember that a relatively small minority of all of the thousands of 

scientists at NIH actually engaged in consulting activities with 

pharmaceutical and biotech. It actually was a small number. 

 MR. WHITFIELD. But now that is banned completely. Is that 

correct? 

 DR. KINGSTON. Yes, it is banned completely. 

 MR. WHITFIELD. Are you going to lose a lot of scientists as a result 

of that? 

 DR. KINGSTON. It is a concern. We have begun--even when we 

announced in the Federal Register the new regulations prohibiting 

outside consulting, we made a commitment to the public that we would 

reassess the impact of those regulations on the agency. There have been 

anecdotal cases of scientists who attributed part of the reason why they 

left the agency recently to these rules. We are in the process of having a 

more formal evaluation of the impact, and if we determine that it is 

harming the agency, we will come to the appropriate decider to decide 

how we can correct it, but we won’t do anything that will allow the 

agency to be vulnerable to the allegation of being not perfectly unbiased 

in our decision-making, and anything that might harm the reputation of 

the agency, we take very seriously. 

 MR. WHITFIELD. So this did send some tremors through the entire 

agency out there. Would that be correct? 

 DR. KINGSTON. I think the tremors were deep. 

 MR. WHITFIELD. Now, the commissioned officers of the Corps, I 

think in your testimony you said they are not under the Uniform Code of 

Military Justice. Is that correct? 

 DR. AGWUNOBI. That is correct. 

 MR. WHITFIELD. And Chairman Barton and Mr. Stupak both talked 

about how the board of inquiry had been delayed because of a request 

from the Justice Department. The Corps is not required by any law to 

delay the board of inquiry, is it? 

 DR. AGWUNOBI. Sir, I should clarify just a little on the UCMJ. 

There are certain circumstances under which the Commissioned Corps 

does subject itself to the Uniform Code of Military Justice, the first being 

our officers were posted to the U.S. Coast Guard. As you know, sir, we 
342

provide healthcare services to the members of the U.S. Coast Guard, our 

sister service. The other is when we are militarized by the President by 

executive order. Now, having said that, I would urge the Chair and 

members to recognize that it is a longstanding practice, indeed there is 

policy that reflects this notion of deferring to criminal investigations 

when we have a civil proceeding underway, and it doesn’t just apply to 

the Commissioned Corps. Indeed, if a civilian working in one of HHS’s 

agencies was referred for criminal investigation and the Department of 

Justice asked the civilian authorities to delay their civil investigation 

because they were worried that it might impinge upon the criminal 

investigation, there are many circumstances in which I imagine even 

civilians would defer to that situation. 

 MR. WHITFIELD. Well, I just may point out that in Oversight and 

Investigations, this subcommittee particularly is involved in a lot of 

oversight and investigation regarding issues in which crime is involved, 

and the Department of Justice comes to us frequently and asks us to 

delay anything and everything we are doing and we seldom do it. 

 DR. AGWUNOBI. Sir, the pursuit of justice is tantamount in our 

minds and in our thoughts. We would be loathe to have a situation 

where our board of inquiry, our investigation into the allegations of any 

Commissioned Corps officer in some way jeopardized or hampered the 

pursuit of a criminal investigation. 

 MR. WHITFIELD. But what about Mr. Walsh? There was no criminal 

investigation with Mr. Walsh, was there? 

 DR. AGWUNOBI. No, sir. My understanding--I don’t know the 

details of either of the cases. I serve in the appellate process in this, in 

our system and I don’t know the details of either case, but I do know that 

the board of inquiry for Mr. Walsh was not delayed because of a request 

by the Department of Justice specifically to that case. 

 MR. WHITFIELD. It was delayed why? 

 DR. AGWUNOBI. We use an office in the Commissioned Corps to 

perform these investigations, to staff and manage these investigations. A 

decision was made when the two cases were presented to us to do the 

most egregious at the time, this was their determination at the time, Dr. 

Sunderland, and to then--potentially egregious, I should correct and say--

and then follow with Walsh. A series of events transpired in which the 

Department of Justice asked us for a 30-day delay, subsequently 

continued to extend their requests for a delay and unfortunately that led 

to a delay in the implementation of the board of inquiry for Dr. Walsh 

until fairly recently. 

 MR. WHITFIELD. And why couldn’t you have done both? 

 DR. AGWUNOBI. It was determined that in order to provide the best 

service, the most efficient service and to ensure that all the procedures 
343

and rules that are a part of the Commissioned Corps were followed, it 

was to be--an operational determination was made that it was better to do 

one after the other. 

 MR. WHITFIELD. But after all of this investigation has been 

completed now, Dr. Kington, I want to make sure I understand, 10 cases 

have been referred to the appropriate officials for criminal investigation. 

Is that correct? 

 DR. KINGSTON. Yes. Following standard policies, we referred--

when there was sufficient concern about a criminal violation, we referred 

I believe a total of 10 to the Inspector General. 

 MR. WHITFIELD. And I acknowledge your commitment to 

maintaining the highest standards for NIH, the institution that is involved 

in such important research for the whole country, for the whole world. 

Are all you really confident that the changes that you have made are 

sufficient and that things can work very well moving forward? 

 DR. KINGSTON. Now I function as the senior ethics official for the 

agency so I have oversight responsibility for all of the personnel-related 

ethics actions, and I can say without any hesitation that we have 

committed an extraordinary amount of thought and resources to actually 

making sure that we have a system that works, and I am confident that 

when the transformation is completed--we are still in the process of 

doing it--we will have an exemplary system and we will be able to 

prevent many potential problems. 

 MR. WHITFIELD. You have so many different institutes out there. 

The fact that you are the chief ethical officer, how do you get it out to all 

the institutes so that they are all on board? 

 DR. KINGSTON. And that is an important question that we asked 

ourselves, how do we have that work. The way it works is that the 

authorities related to the ethics and government act come from the Office 

of Government Ethics. Then there is a senior person who is the 

designated agency ethics official, in this case, Mr. Ed Swindell. I report 

to him for this part of my job, and in a similar way, we are restructuring 

so each of the senior ethics officials at 27 individual institutes and 

centers in turn reports to me. It is in their performance plans. I have an 

opportunity to respond when they are reviewed every year and we are 

setting up a system of random audits that will assess at multiple levels of 

the agency whether or not the ethics rules are being applied rigorously, 

and we have committed the people and the resources and the 

infrastructure to having this work. 

 MR. WHITFIELD. And Dr. Trey Sunderland is still an employee at 

NIH and is involved in certain restricted activities. Is that correct? 

 DR. KINGSTON. Yes. 

 MR. WHITFIELD. Is he at the mental health institute, Dr. Insel? 
344

 DR. INSEL. Yes. If I can respond, there have been a number of 

restrictions of his activities, but again the options we had seemed to us 

were limited. As you may recall at the last hearing, we had a discussion 

about leave with pay, which was one option that I think the 

subcommittee was interested in. We felt that was not appropriate here. 

We have changed his duties so that he is working in a different part of 

the institute. He does not have access to clinical samples that the 

subcommittee was so concerned about before, and there are a number of 

other restrictions in terms of his outside activities and official duties. 

 MR. WHITFIELD. And a lot of those samples have been returned 

also, correct? 

 DR. INSEL. The samples that the previous hearing was about, Pfizer 

samples, have all been returned. 

 MR. WHITFIELD. At this time I recognize the gentleman from Texas, 

Mr. Burgess, for 10 minutes. 

 MR. BURGESS. Thank you, Mr. Chairman, and I appreciate this 

ongoing hearing. 

 Now, the comment was made that Dr. Sunderland was hiding under 

the bureaucracy of the Department of Justice, but I guess I would just 

like to know, would Dr. Sunderland leave if he were free to do so today? 

 DR. INSEL. If I can answer, he asked to leave in November of 2004 

so it is almost the second anniversary of when he asked to be allowed to 

leave the NIH. 

 MR. BURGESS. So his continued presence there is not necessarily 

voluntary at this point? 

 DR. INSEL. By no means. 

 MR. BURGESS. Now, does Dr. Sunderland--let me make sure I 

understand this correctly. Is he purely involved in research or does he 

have clinical duties as well? 

 DR. INSEL. His role has been until recently as the Chief of the 

geriatric psychiatry branch which is a clinical research branch, so he was 

seeing patients, seeing subjects in research studies. 

 MR. BURGESS. So he does have responsibilities that involve direct 

patient care? 

 DR. INSEL. He did. At this point he is no longer involved with direct 

patient care. 

 MR. BURGESS. And when did those stop? 

 DR. INSEL. Oh, I think that goes back to sometime early in 2005. I 

believe it was perhaps either January or February of 2005. 

 MR. BURGESS. You know, without speculating about the guilt or 

innocence or rightness or wrongness of the situation, there are some 

things that come up certainly with your own investigations and with our 

testimony that we have heard here that would call into question 
345

someone’s judgment, and in the clinical practice of medicine, I mean, 

you are only as good as your judgment. I just wonder the wisdom of 

leaving someone whose judgment was called into question and 

continuing to deliver clinical care and be involved clinically with 

patients. In a private or a regular hospital setting, that would be cause for 

summary suspension and a convening of a fair hearing and all of the 

things that you normally would associate with loss of hospital privileges. 

Either Dr. Insel or Dr. Kington. 

 DR. INSEL. If I may respond, it is important to separate out his 

official duty for which there has never been a question about his 

competence or integrity. The issues of patient care, we have certainly 

never gotten a complaint about patient harm or an issue that is related to 

his ability as a geriatric psychiatrist and I think it is probably fair to say 

that he is one of the most highly sought after and highly respected 

geriatric psychiatrists in the country. Part of what I think got him into 

this situation was making bad judgments about taking lots of the 

invitations and being used as a sort of opinion leader in the field. It now 

appears for personal gain as well as for whatever effect he was having on 

the field as well. 

 MR. BURGESS. Right, and that error in judgment, whether it be your 

hand in the till or inappropriately taking invitations, it does beg the 

question, is that judgment impairment that is now evident, is that going 

to spill over into the clinical setting and are patients going to be harmed 

as a direct result? Our responsibility is to the safety of our patients. 

 DR. INSEL. Right. If the question is whether those outside duty 

activities in some ways have contaminated his official duty, what he was 

doing in the hospital, in the clinic, we haven’t seen any evidence of that. 

 MR. BURGESS. Just for recapping for my benefit, the BIOCARD 

study, quickly, what was that again? 

 DR. INSEL. This is a long-term longitudinal study of controls of 

healthy people who are at risk for Alzheimer’s disease because they had 

a first-degree relative with the disease. 

 MR. BURGESS. Dr. Kington, in response to some questions that were 

asked by this committee in June of 2005, the question comes up whether 

the committee was given misleading information from the National 

Institute of Mental Health in response to the committee’s questions on its 

request letter concerning spinal fluid samples that were collected in the 

National Institute of Mental Health lithium study in early Alzheimer’s 

disease patients. The question I believe was were all the records relating 

to tissue samples regarding Dr. Molchan’s lithium study turned over. 

Did we get a misleading answer in our request for that answer of a 

question? 
346

 DR. KINGSTON. I think in retrospect, there probably was--it was 

clear that there was incomplete information that was conveyed to the 

committee but it is also important to recognize that the way that these 

requests were handled were essentially they came into--were largely 

coordinated through the office of the director and then delegated to the 

Director of NIMH to answer the questions. He in turn relied on 

information that was given to him, and the answer could only be as 

accurate as that information that was given to him, and Dr. Insel may 

want to respond as well. 

 MR. BURGESS. If I could, let me just pursue that for a second. Now, 

the samples that have been testified to here today, Pfizer has returned 

those samples? 

 DR. KINGSTON. Pfizer has returned all remaining samples in its 

control. 

 MR. BURGESS. And that was at what? A fifth, an eighth, a half? 

Any rough estimate of how much-- 

 DR. KINGSTON. Actually I don’t know the exact amount. 

 MR. BURGESS. So in addition, the National Institute of Mental 

Health has five storage freezers of samples recovered that Dr. 

Sunderland shipped to New York without proper approval. What will 

the NIH do with the unused and recovered samples from Dr. 

Sunderland’s shipments to advance Alzheimer’s research? In other 

words, will these samples indeed be used in an ongoing study? 

 DR. KINGSTON. And that is under consideration now by NIMH and I 

will let Dr. Insel respond. 

 MR. BURGESS. You testified earlier that that study was not stopped. 

Is that correct? 

 DR. INSEL. There is some confusion here so let us break it down a 

little bit. There are five freezers. Not all of those involve samples that 

were returned from Pfizer. That is actually a relatively small part of the 

entire collection. The five freezers do involve samples that have been 

collected by the geriatric psychiatry branch over many, many years. 

Most of them are cerebrospinal fluid but there are other kinds of samples 

as well. Those aren’t going anywhere. The question remains how they 

will be handled in the future. There needs to be IRB approval and an 

IRB-approved protocol for them to be used in any sort of ongoing or 

collaborative research. The options include such things as maintaining a 

repository--because I do believe these are valuable samples and 

apparently other people believe that as well--that could be used by a 

number of collaborators and at this point we do have an IRB-approved 

protocol with a new principal investigator. If he deems it worthwhile, he 

could find collaborators anywhere who may be interested. In terms of 

this BIOCARD study, the one that you bring up, its value really will 
347

have to be determined at some point in the future. Three hundred and 

fifty subjects, only 14 of them have developed any signs of Alzheimer’s 

disease. It is another 10 years before we can begin to see the 50 or 60 

subjects that will then make this such a valuable study. So we are talking 

long term, and there will be plenty of time to figure out how that will be 

planned out. It will remain though as something that we can hold within-

-this is government property. These are NIH samples. 

 MR. BURGESS. So the delay really hasn’t damaged the value of the 

study? 

 DR. INSEL. Well, the question remains whether those 350 subjects 

are still on board or not. If someone comes back to them 3 years from 

now, are they still going to want to participate or have we lost the very 

critical window when changes are taking place. 

 MR. BURGESS. So at this point, is the BIOCARD study going on at 

NIH or an extramural program anywhere else or in a private institution 

anywhere else? 

 DR. INSEL. There was a BIOCARD, called BIOCARD 2.0 that was 

begun at North Shore Hospital which was Dr. Sunderland’s prospective 

future employee. 

 MR. BURGESS. Should that make any of us up here suspicious? 

 DR. INSEL. It makes me very worried that he would have anything to 

do at this point with that study. That study is actually also terminated 

and the employer has no longer offered him the position that was on the 

table for the last 2 years. 

 MR. BURGESS. Well, maybe sitting on this committee for the last 

year has made me cynical, but I would be very suspicious about that 

activity at North Shore Hospital in regards to what we have learned in 

this committee. Would there have been any way to protect the patients 

from the inconvenience and the disruption in the study and anxiety from 

a move by keeping the study at NIH under the leadership of someone 

else in Dr. Sunderland’s group? Presumably he wasn’t the only one 

involved in that, so did we have other scientists at NIH who could have 

just simply picked this up without inconveniencing and aggravating 

families? 

 DR. INSEL. So there will still be samples there so that is not going 

anywhere, but if we are taking about new accrual of information so 

additional people coming in and additional samples collected toward the 

future, who would do that? When Dr. Sunderland announced he was 

leaving, his deputy, Dr. Robert Cohen, took over. He became the 

principal investigator on this study. Dr. Cohen then decided to leave, I 

believe in September of 2005, and in the effort to find someone else 

could take this over as a principal investigator, Dr. Joel Kleinman 

stepped forward and he had been involved with this study already but he 
348

is not someone who would be able to do the clinical support and the 

clinical evaluations of patients with Alzheimer’s so we have no one in 

place who is able to do that at this time in the intramural program at 

NIMH. 

 MR. BURGESS. Have the rules on outside consulting--and this is a 

question for anyone on the panel. Have the rules on outside consulting 

caused the loss of scientists at NIH? Are the rules overly restrictive at 

this point? 

 DR. KINGSTON. We believe the rules are appropriate for this current 

situation but we are in the process of evaluating its impact. As I said 

earlier, there are individual scientists who have said that the rules played 

a role in their decision to leave the agency. 

 MR. BURGESS. How many scientists have left? 

 DR. KINGSTON. We are just beginning to collect the information on 

that, but it is anecdotal information only up to this point. 

 MR. BURGESS. Is there--I mean, you are the NIH so you are all 

smart people. Is there a way to construct a program that would allow 

with transparency and full disclosure would allow scientists to participate 

in outside consulting to prevent us from losing valuable members of the 

scientific community? 

 DR. KINGSTON. And that is a question we plan to ask ourselves in 

the future but we thought that we shouldn’t even ask that question until 

we have in place comprehensive, well-managed, thorough system of 

oversight of the rules that we have now which are significant. So at 

some point as we stated when the rules were changed, we plan to go back 

and ask that very question, is there some way to allow more outside 

activities, but at this point we do not anticipate considering that question. 

 MR. BURGESS. I hope you are not waiting for the Department of 

Justice. Mr. Chairman, I will yield back. 

 MR. WHITFIELD. Thank you, Dr. Burgess. At this time I recognize 

Mr. Stupak for some additional questions. 

 MR. STUPAK. Thank you, Mr. Chairman. Mr. Chairman, first of al, I 

would like the statement of the Honorable John Dingell be entered into 

the record, please. 

 MR. WHITFIELD. Without objection, so ordered. 

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

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

FROM THE STATE OF MICHIGAN

 Thank you, Mr. Chairman, for holding this hearing and for proceeding in such a 

bipartisan manner. The witnesses who are here today should provide much useful 

information. But I note that the Inspector General (IG) of the Department of Health and 

Human Services (HHS) is not present and apparently has little to say on these matters. 

Congress created the IGs to protect the integrity of the Departments in their charge. 
349

President Reagan called the IGs his “junkyard dogs.” It appears in this case that this IG 

had its teeth pulled. 

 The sad fact is that this Inspector General has returned the responsibility for policing 

the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) 

back to those entities. For example, when this Committee asked the IG on a bipartisan 

basis to determine if the employees at the FDA were accepting drug company money and 

other favors such as those we uncovered at NIH (including at least one instance where an 

FDA official had received permission to engage in 14 separate activities at drug company 

expense), the IG declined. We were informed the IG would merely analyze the FDA 

conflict-of-interest policies for us. 

 A fundamental purpose of the Inspector General is to investigate possible instances 

of criminal misconduct by HHS employees. Without that independent checking, or at 

least the possibility of that review, the laxity and coziness that led to the current problems 

will continue. I hope the result of this current investigation will encourage the 

Administration to reexamine the role of the HHS Inspector General and to determine how 

best to utilize that office. 

 MR. STUPAK. Let me ask this question. It seems like now we take 

this issue very seriously but I have to stop and wonder what was going 

on before this subcommittee staff and probably the L.A. Times really 

pushed you into doing something here. It has been 4 years I think when 

we first brought this to your attention, and when I look at Exhibit #3 that 

I asked about earlier and it says on here, for so many of them, it says 

infraction, failure to adhere to procedures before engaging in outside 

activities which tells me failure to adhere means they didn’t get 

permission before they engaged in outside activities. Either they were 

never asked, they never asked to engage in outside activity for a drug 

company or whatever it is or they were never told. So do you have to fill 

out--even before this investigation, do you have to fill out a yearly 

financial disclosure form about your outside activities? 

 DR. KINGSTON. It depends upon the specific position that a person is 

in. There are approximately 6,000 individuals who every year are 

required to report a confidential disclosure of financial status and then 

there is another 600 or so who every year are required to report one that 

is publicly disclosed and much more detailed. 

 MR. STUPAK. Well, I would take it a medical officer would have to 

disclose, correct? 

 DR. KINGSTON. Probably. It depends upon the specific-- 

 MR. STUPAK. A senior investigator? 

 DR. KINGSTON. Again, probably. 

 MR. STUPAK. Well, actually every one of these that you put down 

on this three or four page document that have failure to adhere to 

procedures before engaged in outside activities. They should have put 

forth this disclosure form before they engaged in outside activities, 

correct? 
350

 DR. KINGSTON. They should have requested permission and then 

having received permission and completed the activity, they should have 

reported the income. 

 MR. STUPAK. But if they didn’t receive the permission, then as a 

backup they should have at least reported the income that they received, 

right? 

 DR. KINGSTON. Right. It didn’t negate the failure to receive prior 

approval-- 

 MR. STUPAK. So they failed to disclose or would it be considered 

making false statements when they signed the form then, perjury when 

they signed the form? 

 DR. KINGSTON. I am not sure of the legal term but it is considered a 

significant violation when the employee reports and signs that they are 

disclosing everything when they haven’t. 

 MR. STUPAK. If it is a significant violation, then why are most of 

these a letter of caution, the action taken against them? 

 DR. KINGSTON. For each case we considered a range of factors, 

again guided by Federal rules, the severity of the action in question, the 

amount of the activity, whether or not the activity was approvable, and 

there was a continuum of severity. For those at the most extreme end, 

we recommended termination. Everything else is dependent upon the 

specifics of the individual case. 

 MR. STUPAK. Sure. Convince me that I am wrong, but here is what 

I see. I spent 12 years in law enforcement. If we even did anything a 

shade like this, we were fired on the spot, okay? And if we wanted a 

board of inquiry, we had to appeal it ourselves. The department sure 

didn’t give us a board of inquiry. We had to do it ourselves. Here is 

what it tells me. I look at this list and all these people, it tells me one of 

a couple things going on here. The agency was so reluctant to 

investigate, it tells me this has been going on for a long, long, long time. 

The soft pedaling is because people who would have been severely 

penalized for which they did, which we believe they should be, probably 

would have started to talk to the press then and said this has been going 

on X amount of years which then leads to the question, what is the 

tentacles of the drug companies in the NIH? As Chairman Whitfield 

says, you do all of our research, all the maybe world’s best research, but 

is it all tainted because of payments made and the influence of drug 

companies and others on the research being done by NIH? Is that--am I 

wrong on that? 

 DR. KINGSTON. We recognize that there was a problem, and we 

responded aggressively. We asked for and received permission to ban 

this type of activity completely at the agency. We did that. With regard 

to soft penalties, I would say that we responded in a way that complied 
351

with every single Federal rule, regulation, and policy which guides the 

penalties and a range of factors are taken into consideration. I would not 

characterize what we did as soft pedaling. Quite the contrary. We did 

exactly what was appropriate and we considered all of the factors that we 

are required by law to consider when we make penalty decisions. 

 MR. STUPAK. Here is the problem. You didn’t even know what was 

going on until this committee and the L.A. Times put it in front of you 

and insisted you do it. The response we initially got--I have been on this 

committee now for 10 years--was sweep it under the rug, forget it, it is 

not going to happen, but because of this staff up here, and the 

subcommittee staff did a great job here, and some L.A. Times articles, 

you never would have done it. So you wouldn’t know to ban it if you 

don’t know it exists. How can you ban something if you don’t realize 

there is a problem? It has been a problem for a long time, and you were 

so reluctant to do it so your comments about we are aggressive doing this 

and that, you can’t ban something you didn’t know was going on. You 

had a financial disclosure form that these people all violated. Every one 

of them had to do it. They all violated it. So I am really concerned that 

the research may not be of the quality and the integrity we hope it would 

be and we rely upon it to be for the American people. 

 DR. KINGSTON. I would disagree strongly with the characterization 

that the industry has tentacles that call into question the validity of our 

research. This was a very small number of individuals. Many people on 

the list that you are holding now were found not to have violated rules. 

The numbers that were found to have violated with penalties was 34. We 

have 18,000 employees. We have a history of remarkable 

accomplishments. When we were informed, I agree, with the 

information that the committee provided to us and other investigations 

provided to us, we did a much more detailed review of the system. 

Perhaps we should have done that sooner. As soon as we had 

information, we aggressively investigated, and as soon as we could, we 

obtained permission to ban this activity entirely. I strongly disagree with 

the characterization that there are fundamental questions about the 

validity of our science. NIH has an extraordinary reputation. That 

doesn’t mean that we can’t improve things. We took your allegations 

and questions very seriously and we acted aggressively, and NIH is a 

different agency now as a result of your bringing this problem to our 

attention. 

 MR. STUPAK. At least for me, I don’t see it as a different agency. 

Four years, you still can’t make a decision on some of these people. You 

soft-sold these people. You should have got them for falsifying records 

if nothing else, if you couldn’t get them for the money, and-- 
352

 DR. KINGSTON. If it was a question of criminal violations, even a 

question of a criminal violation, we referred it to the appropriate 

authorities. We do not have the authority-- 

 MR. STUPAK. Every one of these who have failure to disclose, you 

submitted those failure-to-disclose forms to the Department of Justice for 

criminal investigation? Is that what you are telling me? 

 DR. KINGSTON. I am not a lawyer. I know which specific-- 

 MR. STUPAK. You don’t have to be-- 

 DR. KINGSTON. --criminal code-- 

 MR. STUPAK. --a lawyer to refer it. I am just asking you, did you 

refer all these then? 

 DR. KINGSTON. We referred all of the allegations that considered 

that we thought were in consultation with the Office of the Inspector 

General might involve criminal violations. We referred every one that 

reached that threshold to the Inspector General following standard 

policies that we use to decide how to refer every day when there are 

questions about various activities at the agency. 

 MR. STUPAK. But when you look at this whole thing, you still can’t 

for us tie together requests for outside activities, leave to do work, or 

financial disclosures. It seems like you are still grappling with those 

issues and how to address it at NIH and how you are going to deal with it 

in the future. You have proposals-- 

 DR. KINGSTON. We are-- 

 MR. STUPAK. You have proposals 4 years later. 

 DR. KINGSTON. No, we are grappling with it. In fact-- 

 MR. STUPAK. You are grappling with it? 

 DR. KINGSTON. In fact now, NIH employees cannot receive 

permission to conduct outside consultation with pharmaceutical or 

biotech. 

 MR. STUPAK. I thought you said before an IBR or something like 

that, you said, right? 

 DR. KINGSTON. No, it is unequivocal. NIH-- 

 MR. STUPAK. Let me-- 

 DR. KINGSTON. --employees may not consult-- 

 MR. STUPAK. As of when? 

 DR. KINGSTON. As of promulgation of the rules about a year ago. 

September of 2005 I believe were the final supplemental regulations 

under the Ethics in Government Act. 

 MR. STUPAK. What happens if I fail to disclose my outside activities 

now under these new rules that you have? What happens? 

 DR. KINGSTON. As before, when an employee is found to have 

failed to disclose and comply with the Federal rules, we open a review of 

the case, usually managed by the Office of Management Assessment in 
353

consultation with the ethics officials involved, and then that turns on the 

whole case of-- 

 MR. STUPAK. So in these new rules, if I violate these new rules, you 

don’t spell out what the penalties are? 

 DR. KINGSTON. The penalties are determined by Federal regulations 

and-- 

 MR. STUPAK. So we are right back to where we are here today. 

 DR. KINGSTON. Actually, no. 

 MR. STUPAK. Because every one of these people had to fill out the 

form, they didn’t do it properly, they did not get permission or they 

failed to disclose and there is no discipline other than a letter of caution. 

Even under your new rules, if I fail to disclose or I don’t get permission, 

it is going to go back to the same board that is going to take a look at the 

Federal rules and regulations and say hmm, well, I guess we give them a 

letter of caution again because that is what you did already. You set the 

precedent. I would think-- 

 DR. KINGSTON. No, we followed-- 

 MR. STUPAK. --you would have some new rules-- 

 DR. KINGSTON. --Federal law. 

 MR. STUPAK. I would think you would have some new rules and 

those new rules say if you fail to disclose, you will get a minimum 3 to 7 

days off, depending on the amount of money, it may be higher. It could 

even result in termination. I would think that is what you would want to 

do to keep the integrity, but to go back into this and say well, we will 

look at the Federal law and see what Federal law says and maybe a 

couple years later we will make a decision. I don’t have any confidence 

in what you are going to do. I see us right back to where we are right 

here, and maybe in 6 years if we are still up here, all of us who have been 

here for a while, we will come back and say oh, I guess we are back at 

hearing number eight on this NIH research and the influence and fail to 

disclose, failure to give financial disclosures and all that and we are 

going to be right back where we are. 

 DR. KINGSTON. NIH is not where we are. Unequivocally we are not 

where we were. The rules prohibit consultation as an outside activity 

with industry. It is not allowed. Anyone who does it is violating Federal 

regulations. We are not the agency that we were before. We have a 

greatly expanded, more comprehensive ethics review system. I have no 

question that if anyone actually comes and actually drills down and looks 

at how we are actually implementing rules, you will see that we are 

rigorously reviewing and enforcing the regulations. We are a different 

agency in this dimension as a result of this review. 

 MR. STUPAK. Without some affirmative statement, they will look at 

the past precedent, and based upon past precedent, every lawyer will 
354

argue that is what you have to do because that is what you did in 2006 

and that is what you are going to have to do in 2010 and 2014. I will 

stand by my statement which I basically mean, this has been going on for 

a long time, long before this committee brought it before, and I believe 

the tentacles of the drug companies influence the research of the NIH, 

much to the dismay of the American people. 

 DR. KINGSTON. We disagree with that characterization. 

 MR. BURGESS. The gentleman’s time has expired. Do you have any 

objection if I have a second round of questions? Thank you. Dr. 

Kington, I can’t believe that with that last thought, I mean clearly there is 

a benefit for having a relationship between a pure research structure 

which is the National Institutes of Health and the private companies, the 

pharmaceutical companies and the biotech companies on the outside. 

There is no question that there are great things happening at the NIH but 

in order to deliver those great things into the treatment rooms and into 

the operating rooms and into the hands of the American people, it does 

require a collaboration between NIH and the private sector. Would you 

agree with that statement? 

 DR. KINGSTON. Yes. 

 MR. BURGESS. And I guess I am also a little troubled because I 

haven’t been here for 10 years and when I came in, it was roughly 

around the time that you promulgated the new rules that were very 

restrictive as far as allowing researchers at NIH to collaborate or to work 

in consultation with outside sources, and again, I am concerned about a 

young person who shows great promise and a great mind not availing 

themselves of a career at the NIH because after all, it is a dead-end job. 

You can’t go anywhere. Your earnings are capped and you will do far 

better if you work for someone in one of the pharmaceutical houses or 

one of the biotech companies. Is that a concern of the NIH? 

 DR. KINGSTON. It is a concern. We believe that we offer a really 

extraordinary and unique place to conduct scientific research. It is also 

important to note that we can still and do engage in collaborative 

research with industry. We do it using many different mechanisms 

including what is called a CRADA, a cooperative research and 

development agreement, which is done in a very transparent, open, 

competitive way in which we actually have an explicit agreement to 

work together with industry to develop an area of science. So there are 

opportunities for our scientists to work collaboratively in their official 

capacity and we are concerned about, that we have to provide the type of 

environment that allows us to continue to recruit and retain the very best 

researchers and we will be monitoring that on a continuing basis. 

 MR. BURGESS. And in general, has Congress been helpful to you 

toward that goal or hurtful? 
355

 DR. KINGSTON. This has been a painful process for us but we think 

that we are a better agency as a result. 

 MR. BURGESS. Let me--and I will just say, I have made several trips 

out to the NIH and I am always just absolutely astounded by the way 

your researchers have the ability to look over the horizon and see things 

that are coming that the rest of us would never even consider. 

 But Dr. Niederhuber, let me just ask you a couple of questions. We 

have had you here and I came in late and I don’t know whether anyone 

has bothered you or not on this panel. Dr. Thomas Walsh, that name has 

come up. You are familiar with Dr. Walsh? 

 DR. NIEDERHUBER. Yes. 

 MR. BURGESS. Now, as I understand it, Dr. Walsh was involved in 

some of the same types of activities that Dr. Sunderland was, but perhaps 

not nearly to the degree that Dr. Sunderland was involved. Is that a fair 

characterization? 

 DR. NIEDERHUBER. Yes, I think that is fair. 

 MR. BURGESS. In your--and by the way, welcome and 

congratulations on being the new head of the NCI. I think that is 

tremendous. Andy Esenbach was always a good friend. I look forward 

to him doing good things over at FDA. But have you exercised your 

supervisory authority to restrict Dr. Walsh’s workplace activities and 

some of his outside activities given the nature of the allegations? 

 DR. NIEDERHUBER. Yes. We have certainly restricted his outside 

activities as Dr. Kington has indicated. Dr. Walsh, as you may know, is 

probably the world’s expert on antifungal agents and a very distinguished 

and compassionate physician. He still is a very valuable part of the 

clinical team in terms of the patient work that we do at NCI because of 

that expertise. 

 MR. BURGESS. Would you regard the infractions alleged to have 

been committed, were they serious violations? 

 DR. NIEDERHUBER. We certainly agree that these were serious. 

These were in many ways acts of omission in terms of reporting, 

shouldn’t have taken place, certainly violated the code of conduct for the 

NCI and the NIH. 

 MR. BURGESS. Was there consideration given to terminating the 

relationship with this individual? 

 DR. NIEDERHUBER. Yes. 

 MR. BURGESS. And what was the decision there? 

 DR. NIEDERHUBER. We in November of 2005 made that 

recommendation. 

 MR. BURGESS. That his service would be terminated? 

 DR. NIEDERHUBER. Yes. 

 MR. BURGESS. And what is the status of that currently? 
356

 DR. NIEDERHUBER. That is--as Dr. Agwunobi has said, the Admiral 

has said, it is under current review. 

 MR. BURGESS. So that--Admiral, that is under the same status that 

we were informed for Dr. Sunderland? 

 DR. AGWUNOBI. No, sir. A board of inquiry has been ordered by 

the Acting Surgeon General. 

 MR. BURGESS. Can a scientist at the National Cancer Institute 

accept gift donations specifically to support his lab or her lab from a drug 

company in exchange for services performed for the drug company, Dr. 

Niederhuber? 

 DR. NIEDERHUBER. Not at this time. 

 MR. BURGESS. At any time in the past has that been-- 

 DR. NIEDERHUBER. I am not sure I know the answer to that. I defer 

that to Dr. Kington. He would probably know the history better than I 

do. 

 DR. KINGSTON. I don’t believe it was ever explicitly approved to 

have a quid pro quo, but again, this is a sort of special area of law that I 

am not specifically familiar with. 

 MR. BURGESS. Well, Dr. Niederhuber, currently does the NCI 

conduct any conflict-of-interest review over gifts such as these, gifts that 

would be given to a specific researcher in return for specific work? 

 DR. NIEDERHUBER. Gifts can--at this time, we have a system, and 

Dr. Kington can also comment on this, but we have a system through the 

foundation of NIH in which we keep our science and our scientists really 

at arm’s length so it is a way of continuing to work with the private 

sector, but it is done through a process and a foundation that keeps our 

scientists directly away from the source of those gifts and the company. 

Is that a fair--do you want to comment further-- 

 DR. KINGSTON. And we would be happy to sort of comment for the 

record in more detail about this specific question if there are specific 

questions you had about how the policy was implemented for accepting 

gifts. 

 MR. BURGESS. Very well. Well, under what conditions would a 

scientist at the National Cancer Institute be able to assist a drug company 

with advisory meetings with the FDA? 

 DR. NIEDERHUBER. Well, we have--we are working on putting a 

very specific policy in place. That is not quite completed yet. Dr. 

Kington can comment again on that. But the only way at this time that I 

am aware that one of our distinguished scientists with specific expertise 

that could be helpful to the American people, helpful to the specific 

committee of the FDA reviewing a particular question would be in the 

official line of duty as an expert, more or less an expert witness to that, 

not as a representative of any outside agency. 
357

 DR. KINGSTON. It is important to note that NIH employees may not 

under Federal law appear before the Food and Drug Administration as a 

representative of a private company. It is a violation of Federal law to do 

that. There may be circumstances in which the expertise of an NIH 

scientist is appropriately brought to bear to aid the sister agency in 

assessing the science and that can and does happen. As Dr. Niederhuber 

pointed out, we are in the midst of developing clearer guidelines so that 

everyone understands what the criteria are for deciding when it is 

appropriate to do that. 

 MR. BURGESS. Well, again, I want to thank everyone for--oh, I beg 

your pardon. The Chairman is back. The Chairman is recognized for-- 

 CHAIRMAN BARTON. I just have a few wrap-up questions. I want to 

go back to try to tie this thing down on this court of inquiry with the 

Assistant Secretary for Health and I mispronounced your name, 

Agwunobi. Is that close? 

 DR. AGWUNOBI. Thank you, sir. That is perfect. 

 CHAIRMAN BARTON. I at least want to try to get your name right. 

When do you expect the court of inquiry to be convened on Dr. 

Sunderland? 

 DR. AGWUNOBI. As per our policy, sir, when we receive clearance 

from the Office of Inspector General, we will proceed. The orders have 

been written and the board is currently suspended pending receipt of that 

clearance. 

 CHAIRMAN BARTON. When do you expect to get that? 

 DR. AGWUNOBI. Sir, I would be reluctant to guess. 

 CHAIRMAN BARTON. Well, guess. 

 DR. AGWUNOBI. Sir, not knowing the ongoing details of the 

criminal investigation, not knowing what the allegations are specifically 

and where and what-- 

 CHAIRMAN BARTON. Are you going to do anything as a 

consequence of today’s hearing to try to expedite the convening of that 

board of inquiry? 

 DR. AGWUNOBI. Sir, I can assure you that as soon as we receive 

clearance to proceed, we will proceed immediately. 

 CHAIRMAN BARTON. But you are not going to do anything to get 

clearance to proceed? 

 DR. AGWUNOBI. Sir, we are going to continue to seek to avoid any 

intervention that would hamper the pursuit of justice in a criminal 

investigation. 

 CHAIRMAN BARTON. So you are not going to do anything? 

 DR. AGWUNOBI. Sir, we are following all our policies and we stand 

ready to-- 
358

 CHAIRMAN BARTON. No, you are not. You are sitting on your 

bottom and you are not doing anything. Be honest about it. 

 DR. AGWUNOBI. No, sir. 

 CHAIRMAN BARTON. How long has it been since Dr. Insel 

recommended Dr. Sunderland be terminated? 

 DR. AGWUNOBI. I am not sure when Dr. Insel made the 

recommendation. 

 CHAIRMAN BARTON. How long has it been, Dr. Insel? 

 DR. AGWUNOBI. I can tell you that the NIH first responded--first 

indicated to us in December of 2005, I think that is correct, they would 

like for us to pull together a board of inquiry. The order was written 

pretty much within 60 days and suspended quickly upon the receipt of a 

request to do so. 

 CHAIRMAN BARTON. Dr. Insel, how long has it been? Is he correct? 

Is that November of 2005? 

 DR. INSEL. I think the letter was November 21, 2005. 

 CHAIRMAN BARTON. Are your hands tied until this court of inquiry 

is convened? 

 DR. INSEL. Well, as far as I can tell, we are using up our options. 

We can restrict activities but he is still with us until we have a decision 

from the Commissioned Corps. 

 CHAIRMAN BARTON. And Dr. Kington, is it NIH policy that when 

another agency requests your agency to do something, you stop 

everything you are doing and don’t take any further action until that 

agency is satisfied with its action? 

 DR. KINGSTON. I don’t think as a rule there is an explicit policy but 

in general-- 

 CHAIRMAN BARTON. Well, is it a rule that if the Department of 

Justice--that there is going to be no pressure exerted on the 

Commissioned Corps to do this court of inquiry until the Department of 

Justice says it can? Is that your rule? 

 DR. KINGSTON. No, but the practice has-- 

 CHAIRMAN BARTON. Do you have the ability to do the court of 

inquiry without the permission of the Department of Justice? 

 DR. KINGSTON. We don’t conduct the board of inquiry. The-- 

 CHAIRMAN BARTON. I know that. 

 DR. KINGSTON. --Commissioned Corps does, so we can’t--so the 

answer is, we cannot. 

 CHAIRMAN BARTON. But the Inspector General is part of Dr. 

Zerhouni’s management team. 

 DR. KINGSTON. Well, actually, the Inspector General is an office of 

the Secretary of the Department. They are the official liaison with the 
359

Department of Justice for us so--but in any case, the board of inquiry--we 

can’t conduct a board of inquiry. 

 CHAIRMAN BARTON. I understand that. I am not asking you to 

conduct it. I am asking you to help expedite it. The Commissioned 

Corps is not going to do anything. They will be sitting here 3 years from 

now saying they can’t do anything if the Department of Justice has an 

ongoing investigation. 

 DR. AGWUNOBI. Sir, we are in constant communication with the 

Department of Justice. We are working closely with-- 

 CHAIRMAN BARTON. As far as I am aware, it is not a law of the 

United States that one agency cannot conduct its own disciplinary action 

subsequent to a criminal investigation at another agency. Now, that may 

be the practice and that may be a gentleman’s agreement but it is not the 

law. 

 DR. AGWUNOBI. Sir, it is a policy within the Commissioned Corps 

that we-- 

 CHAIRMAN BARTON. Well, I am going to formally recommend that 

you make an exception to that policy. You have somebody thumbing his 

nose at the entire NIH code of ethics and you folks don’t seem to care. 

This committee cares. And I am going to call Dr. Zerhouni and I will 

talk to the Inspector General and we are going to get in touch with the 

Department of Justice, but it is a farce of what the American people think 

is right and wrong to not be able to go forward because the Department 

of Justice has a pending investigation. I have worked with the 

Department of Justice for 20 years and they have some investigations 

that go on for 20 years. So if you wait for them to finish their 

investigation, you may be waiting. In fact, you may retire without it 

happening, and my guess is, if I have the staff call over to DOJ or I call 

the Attorney General, they’re going to say we haven’t told the 

Commissioned Corps they can’t do their board of inquiry; we just let 

them know that we have a pending investigation. I mean, I have been 

down that road before. So, you know, this is not a good day for truth and 

justice in the American system because you have at least one individual 

who appears to have really committed some egregious violations and he 

is not being held accountable, and I think that is wrong. And with that, I 

yield back, Mr. Chairman. 

 MR. BURGESS. I thank the Chairman of the full committee. With 

that, not seeing any other Members who wish to speak, I want to thank 

the panel of witnesses for their attendance today and their testimony. We 

certainly appreciate their participation in this hearing. 

 This hearing will stand adjourned. The record will remain open for 

the requisite 30 days. 
360

 MR. STUPAK. And Mr. Chairman, just one more. Written questions 

will be included in for the hearing? 

 MR. BURGESS. Correct. 

 MR. STUPAK. Thank you. 

 [Whereupon, at 3:31 p.m., the subcommittee was adjourned.] 

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