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S. HRG. 111–305 

MEDICAL RESEARCH AND EDUCATION: HIGHER 

LEARNING OR HIGHER EARNING? 

HEARING 

BEFORE THE

SPECIAL COMMITTEE ON AGING 

UNITED STATES SENATE 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

WASHINGTON, DC 

JULY 29, 2009 

Serial No. 111–11 

Printed for the use of the Special Committee on Aging 

( 

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html 

SPECIAL COMMITTEE ON AGING 

HERB KOHL, Wisconsin, Chairman 

RON WYDEN, Oregon 

BLANCHE L. LINCOLN, Arkansas 

EVAN BAYH, Indiana 

BILL NELSON, Florida 

ROBERT P. CASEY, Jr., Pennsylvania 

CLAIRE McCASKILL, Missouri 

SHELDON WHITEHOUSE, Rhode Island 

MARK UDALL, Colorado 

KIRSTEN GILLIBRAND, New York 

MICHAEL BENNET, Colorado 

ARLEN SPECTER, Pennsylvania 

AL FRANKEN, Minnesota 

MEL MARTINEZ, Florida 

RICHARD SHELBY, Alabama 

SUSAN COLLINS, Maine 

BOB CORKER, Tennessee 

ORRIN HATCH, Utah 

SAM BROWNBACK, Kansas 

LINDSEY GRAHAM, South Carolina 

SAXBY CHAMBLISS, Georgia 

DEBRA WHITMAN, Majority Staff Director 

MICHAEL BASSETT, Ranking Member Staff Director 

(II) 

C O N T E N T S 

Page 

Opening Statement of Senator Herb Kohl ............................................................. 1 

Opening Statement of Senator Mel Martinez ....................................................... 3 

Opening Statement of Senator Al Franken ........................................................... 4 

PANEL I 

Statement of Lewis Morris, Chief Counsel to the Inspector General, U.S. 

Department of Health and Human Services, Washington, DC ........................ 6 

Statement of Steven Nissen, M.D., Chairman, Department of Cardiovascular 

Medicine, Cleveland Clinic, Cleveland, OH ....................................................... 17 

Statement of Eric Campbell, Ph.D., Associate Professor, Director of Research, 

Institute for Health Policy, Massachusetts General Hospital, Harvard Medical School, Boston, MA ....................................................................................... 22 

Statement of Jack Rusley, Chairman, Culture of Medicine Action Committee, 

American Medical Student Association; Student, Brown University, Alpert 

School of Medicine, Providence, RI ..................................................................... 30 

PANEL II 

Statement of Thomas Stossel, M.D., Translation Medicine Division and Senior 

Physician, Hematology Division, Brigham & Women’s Hospital, Harvard 

Medical School, Boston, MA ................................................................................ 43 

Statement of James Scully, M.D., Medical Director and CEO, American Psychiatric Association, Arlington, VA ..................................................................... 57 

Statement of Murray Kopelow, M.D., MS, FRCPC, Chief Executive, Accreditation Council for Continuing Medical Education, Chicago, IL ........................... 65 

APPENDIX 

Statement submitted by the Advanced Medical Technology Association 

(AdvaMed) ............................................................................................................. 111 

Testimony of Dr. Richard Murray, Vice President of External Medical and 

Scientific Affairs, Merck & Co., Inc. ................................................................... 115 

Statement of Dr. Robert Golden, Dean, University of Wisconsin School of 

Medicine and Public Health ................................................................................ 118 

Testimony submitted by Norman Kahn, MD, Executive Vice-President and 

CEO, Council of Medical Specialty Societies ..................................................... 122 

Testimony submitted by Daniel J. Carlat, M.D., Associate Clinical Professor, 

Tufts University School of Medicine ................................................................... 126 

Testimony submitted by Adriane Fugh-Berman MD, Director, PharmedOut 

Department of Psysiology and Biophysics, Georgetown University Medical 

Center .................................................................................................................... 131 

Testimony submitted by North American Association of Medical Education 

and Communication Companies, Inc. ................................................................. 136 

Additional information submitted by Jack Rusley, Sunshine Act Statement 

from AMSA and a Fact Sheet on CME from the Prescription Project ............ 144 

(III) 

(1) 

MEDICAL RESEARCH AND EDUCATION: 

HIGHER LEARNING OR HIGHER EARNING? 

WEDNESDAY, JULY 29, 2009 

U.S. SENATE, SPECIAL COMMITTEE ON AGING, Washington, DC. 

The Committee met, pursuant to notice, at 2:03 p.m. in room 

SD–562, Dirksen Senate Office Building, Hon. Herb Kohl (chairman of the committee) presiding. 

Present: Senators Kohl [presiding], Franken, and Martinez. 

OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN 

The CHAIRMAN. Good afternoon to everybody. We are going to 

call this hearing to order at this time. We thank you all for being 

here with us today. 

Today’s hearing is the fourth in a series of hearings we’ve held 

on the financial relationship between drug and device industries 

and America’s physicians. To provide patients with the best possible care, the practice of medicine requires medical students to absorb vast amounts of unbiased information over a number of years. 

Further, it demands that doctors continue their training long after 

they have finished school. 

Officially, doctors are required to participate in continuing medical education, or CME, to retain their license to practice, but many 

other opportunities for ongoing medical education exist in the form 

of medical journals, conferences, and speakers’ bureaus, as well as 

professional societies. 

In recent years, the drug and device industries have become increasingly involved in the funding of education for doctors. Academic medical centers and medical schools are increasingly reliant 

on industry funding for their educational and research programs. 

Industry funding of CME has quadrupled in the past decade, and 

now totals over $1 billion a year. As both Congressional and media 

scrutiny of the financial relationships between physicians and 

these industries has heightened, this type of indirect funding is 

considered to be the last frontier. 

Providing ongoing training and access to the latest medical innovations is costly, to say nothing of the resources necessary to 

produce the research in the first place. Teaching hospitals and 

medical schools face rising costs, as well. From that perspective, industry funding is fulfilled a real need. But, as we now know, large 

corporations do not typically spend these sums unless they think 

that they will get something out of it. That’s not an indictment of 

the drug and device industry, it’s simply how business works. 

2 

This brings us to the crux of today’s hearings, as the drug and 

device industries—Are the drug and device industries getting a return on their annual billion dollar investment in medical education? Do the programs funded by industry stay true to their mission of providing unbiased education and research, or do they instead market the industries’ latest products? We are not suggesting 

that these financial relationships are rife with corruption, but it’s 

clear to us that greater transparency, and perhaps stronger firewalls, need to be considered. 

We will hear from respected physicians and a medical student 

association who will say that industry funding does have an influence on the information and material presented to doctors; and 

we’ll hear from the Department of Health and Human Services Office of the Inspector General and a member of the Institute of Medicine committee investigating these issues, who contend that most 

medical schools, as well as professors’ societies, are far from implementing the policies necessary to combat conflicts of interest. 

We’ll also hear from a new organization of respected medical professionals who believe that industry funding of medical research 

and education has been a positive development, and that restricting such industry funding would be counterproductive. We’ll hear 

from the organization that grants approval to official CME programs about the recent regulations they’ve put in place to ensure 

the integrity of CME content. 

Finally, though they will not be testifying today, we’ve been corresponding with the American Medical Association. In spite of the 

fact that these conflicts of interest have been on their radar screen 

for quite some time now, I’m disappointed that they have not yet 

updated their ethical guidelines on the topic, as other trade groups 

such as PhRMA and AdvaMed have, and I hope this is remedied 

soon. 

Before we begin, I’d like to make mention of Senator Chuck 

Grassley’s work and leadership in this area. He and I have collaborated on several investigations, and most recently have been working to bring transparency to the Federal funding of biomedical researchers. Together we are the cosponsors of the Physician Payments Sunshine Act, a bill to require drug and device companies 

to disclose payments to doctors. We’re hopeful that provisions of 

our bill will be included in the Finance Committee’s healthcare reform proposal. 

I’d also like to thank Chairman Waxman and Chairman Stark, 

in the House, for including provisions of our bill in their healthcare 

reform proposal, and for broadening the language to include payments by drug and device companies to medical schools, sponsors 

of continuing medical education programs, and organizations of 

healthcare professionals. 

We’d like to salute those drug and device companies, such as 

Merck, Eli Lilly, and Pfizer, who have voluntarily begun to change 

their policies in this area. Notably a professional medical society, 

the American Psychiatric Association, has also taken steps in this 

direction, and we will hear from them today. 

I think we all agree that conflicts of interest in this area, whether real or apparent, are not worth losing the public’s trust. 

3 

So, we’re happy that you’re all here with us today. I’d like to call 

on Senator Martinez, who’s the ranking member, and then on Senator Franken, from Minnesota, our newest member. 

Senator Martinez. 

OPENING STATEMENT OF SENATOR MEL MARTINEZ, RANKING 

MEMBER 

Senator MARTINEZ. Thank you, Mr. Chairman, very much, and 

thank you for calling this very timely hearing. 

I’d like to just add my word of welcome to our newest member, 

Senator Franken. We welcome you to the committee. 

Senator FRANKEN. Thank you, Senator. 

Senator MARTINEZ. I think you’ll find our work interesting and 

worthwhile, and we’re glad you’re here. 

The subject of transparency in the medical profession is timely, 

given the current debate over the high cost associated with 

healthcare. We know that doctors, in pursuit of their profession, 

spend many, many years of preparation and study, very costly 

years, before they begin their practice of medicine. Then, to stay 

current in the medical field, and to maintain a medical license, doctors devote substantial time to develop their medical knowledge 

and skills through continuing medical education. For these reasons, 

doctors are rightfully held in high esteem by the general public and 

their patients. This is why accounts of ethical and legal lapses by 

some doctors and pharmaceutical companies are especially troubling. These ethical lapses raise questions about patient well- being 

and stewardship of taxpayer dollars. 

One arrangement we’ll hear about today involves off-label promotion of a prescription drug that purports to be independent in 

continuing medical education. Today, doctors and patients enjoy access to an abundance of information from numerous sources. Patients rely on doctors to sift through this information and use it to 

make sound judgments about the benefits and risks of certain medical procedures, drugs, and devices. While off-label prescribing by 

doctors is legal and, in many instances, appropriate, promoting a 

drug for off-label purposes by a drugmaker is not. Continuing medical education is essential for disseminating information that helps 

doctors make decisions about appropriate off-label use of a drug. 

Sometimes the line between promotion and education can be 

blurred. This is why transparency and appropriate commonsense 

safeguards are absolutely necessary. 

While industry support of continuing medical education is an important source of funding for medical education, transparency and 

appropriate safeguards are crucial to maintaining the integrity of 

medical decisionmaking. Disclosing payments to doctors, be they 

for Medicaid or from pharmaceutical companies, allows the public 

to reach their own conclusions about the appropriateness of such 

payment agreements. 

Transparency is the bedrock of the legislation that was introduced earlier this year, by me and others, the Medicaid Accountability Through Transparency Act, or MAT Act. It’s consistent with 

Chairman Kohl’s and Senator Grassley’s bill, the Physicians Payment Sunshine Act. 

4 

I look forward to hearing from our witnesses about this important matter. Mr. Chairman, I thank you, once again, for calling another very interesting topic to our attention. 

The CHAIRMAN. Thank you, Senator Martinez. 

Senator Franken. 

OPENING STATEMENT OF SENATOR AL FRANKEN 

Senator FRANKEN. Thank you, Chairman Kohl. I’m very pleased 

to be a member of this committee. Thank you, Ranking Member. 

I’m looking forward to working with both of you and all the other— 

well, with both of you— [Laughter.] 

The rest of the committee, as we make progress on the issues 

that affect Americans’ quality of life as we all age. 

I thank Chairman Kohl and Senator Grassley for shedding light, 

in recent years, on the influence of the pharmaceutical industry on 

healthcare, and for leading Federal efforts to reduce industry influence with the Physicians Payment Sunshine Act, which I am now, 

by the way, a cosponsor of, and proudly so. 

When I think about conflicts of interest in healthcare, I come 

back to the most important question, How are patients affected? As 

we know from past hearings in this committee, the status quo allows almost unlimited, and far from impartial, interactions between physicians and industry. To me, what is most disturbing 

about the current situation is that these relationships between industry and providers don’t often benefit patient care. In fact, research has shown that they often have a negative influence on patient outcomes. They drive up healthcare costs because providers 

make treatment decisions based upon materials generated by industry, not based upon unbiased, evidence-based scientific information. 

I’m proud that my State of Minnesota was the first State to 

enact legislation, in 1993, requiring public reporting of drug-company marketing payments to doctors. However, based on our experience in Minnesota, we know that transparency isn’t enough. Even 

under Minnesota’s progressive State law, the influence of industry 

on healthcare is rampant. 

I believe you’re all familiar with the 2007 New York Times article about a 12-year-old Minnesota girl who was, tragically, treated 

with inappropriate medication prescribed by a psychiatrist, and she 

has had lifelong health problems as a result. It turned out that the 

psychiatrist had received more than $7,000 from the maker of the 

drug. 

The same year, a study of the Journal of the American Medical 

Association showed that between 2002 and 2004 more than 7,000 

payments to physicians, totaling almost $31 million were reported 

in Minnesota. All of this took place under the State’s exemplary 

public reporting laws, which goes to show that, while transparency 

is a necessary first step, it is not sufficient. 

Since we know that the influence of pharmaceutical companies 

begins in medical school, it’s crucial that we get to the root of this 

issue. Today’s hearing gives us a chance to learn more about this, 

and my goal is to understand what steps the Congress can take to 

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viders to make decisions based on the scientific evidence, and not 

on biased information. 

Previously discussed in past hearings is the Institute of Medicine 

report, which describes the medical schools’ over-reliance on industry funds. The same can be said for continuing medical education 

programs, as we’ve talked about today. 

I’m proud that, in Minnesota, we have an institution that can be 

held up as an example of how to effectively reduce conflict of interest in medical education. Mayo Medical School was one of nine 

medical schools across the country which received an ‘‘A’’ on the 

American Medical Student Association Assessment of Academic 

Medical Center Policies. I believe we have a gentleman testifying 

today from that association. 

It’s my understanding that Mayo has strong policies governing 

gifts, consulting relationships, and pharmaceutical samples. Medical students also receive a specific curriculum developed to create 

a culture of providers who make independent decisions based on 

the best interest of the patient. But, I’d like to hear more from our 

witnesses on how we can move toward making the rest of the country more like Mayo. 

Finally, I commend Chairman Kohl and Ranking Member Martinez on the timing of the hearing. It couldn’t be better, as the 

Ranking Member said, because it’s enormously relevant to the 

broader discussion of national healthcare reform. It’s counterproductive to be discussing reforming the healthcare system while 

allowing industry to maintain its hold on physicians’ decisions. 

Nationwide, prescription-drug spending rose 500 percent between 

2000 and 2005—500 percent—from 40.3 billion to 200.7 billion per 

year. But, while these costs to consumers grow exponentially, the 

pharmaceutical industry is spending an astonishing $30 billion annually on marketing. We have created a culture in which physicians receive far too much information about drugs from pharmaceutical reps, who have a vested interest in selling the newest, 

highest-cost products. To ensure high-quality care and to control 

soaring drug costs, we must provide medical students and physicians with information that is based on the best science, and not 

the most expensive marketing tactics. As lawmakers, I believe it is 

our job to remove barriers that create unnecessary costs and unethical influence in the healthcare system. 

Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you, Senator Franken. 

Now to our first panel. Our first witness on the panel will be 

Lewis Morris, who is Chief Counsel for the Office of the Inspector 

General in the Department of Health and Human Services. In this 

role, Mr. Morris oversees a staff of 70 individuals who provide legal 

guidance to the inspector general. He’s also working on an ongoing 

assessment of conflicts on interest in medical education with his research partner, Dr. Julie Taitsman, the OIG’s Chief Medical Officer. 

Next witness today will be Dr. Steven Nissen, who is Chairman 

of the Department of Cardiovascular Medicine at the Cleveland 

Clinic. Previously, Dr. Nissen served as President of the American 

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ican cardiologists. In addition to these positions, Dr. Nissen has 

written extensively on drug safety matters. 

Next we’ll be hearing from Dr. Eric Campbell, the Associate Professor at the Institute for Health Policy, and the Department of 

Medicine at Massachusetts General Hospital and the Harvard 

Medical School. Dr. Campbell has conducted extensive research in 

understanding the effects of academic-industry relationships on 

biomedical research, and he serves on the Institute of Medicine’s 

Committee on Conflict of Interest in Medical Research, Education, 

and Practice. 

Finally, we’ll be hearing today from Jack Rusley. Mr. Rusley is 

a fourth-year medical student at the Alpert Medical School of 

Brown University. He is the Chair of the Culture of Medicine Action Committee for the American Medical Student Association, and 

is a Doris Duke Clinical Research Fellow at Yale Medical School. 

Currently, he is the Director of the AMSA PharmFree Scorecard. 

We welcome you all, and we hope you will limit your comments 

to 5 minutes, if you can, please. Mr. Morris, let’s hear from you 

first. 

STATEMENT OF LEWIS MORRIS, CHIEF COUNSEL TO THE INSPECTOR GENERAL, U.S. DEPARTMENT OF HEALTH AND 

HUMAN SERVICES, WASHINGTON, DC 

Mr. MORRIS. Good afternoon. On behalf of the Office of Inspector 

General for the U.S. Department of Health and Human Services, 

thank you for the opportunity to discuss commercial sponsorship of 

continuing medical education, or CME. 

Physicians must be kept abreast of advances in medicine, and access to objective, unbiased CME is essential to the quality of medicine practiced in this country. A productive collaboration between 

medicine and commercial interests can expand knowledge, drive innovation, and improve quality of care. 

However, the relationship also contains a potential divergence of 

interest. Physicians must make the welfare of the patient their 

first priority. On the other hand, healthcare companies strive to increase market share. Industry-sponsored medical education can be 

an effective means to accomplish that business objective. 

In 2007, drug companies spent more than a billion dollars to 

cover more than half of the cost of CME activities in that year. Researchers have found that commercially sponsored CME gives more 

favorable treatment to the sponsor’s product than do programs that 

are not commercially funded. Given the mixed motivations of industry-sponsored education, it is essential that effective safeguards 

be in place to ensure that CME is free from commercial bias. 

The Accreditation Council for Continuing Medical Education, or 

ACCME, plays a pivotal role in ensuring the integrity of CME. 

However, the current environment tolerates industry sponsors’ 

preferential funding of programs that serve their business needs. 

Developing curricula biased in favor of the funder’s economic interest is a logical outgrowth of CME providers seeking commercial financial support. 

As a result, research has shown that industry-sponsored CME almost exclusively covers topics related to commercial products, instead of broader discussions of patient care. 

7 

Various Federal laws may also be implicated by industry sponsorship of CME. As my written testimony explains in detail, when 

a manufacturer misuses CME for the purpose of an off-label promotion of a drug or medical device, the Food, Drug, and Cosmetic 

Act may be implicated. A violation of the False Claims Act may 

also be triggered when a manufacturer’s illegal, off-label promotion 

of a drug or device results in the submission of claims to the Federal healthcare programs. 

Industry sponsorship of CME can also create liability under the 

criminal anti-kickback statute. Offering doctors money or other 

benefits to induce them to prescribe the manufacturer’s product is 

illegal if the product is reimbursed by the Federal healthcare programs. When pharmaceutical manufacturer rewards a high-prescribing physician by directing a CME provider to pay, or overpay, 

that physician to be a CME faculty, that payment may be a kickback. 

In light of the risks posed by commercial sponsorship of medical 

education, the question becomes how to best ensure the CME programs are not co-opted as marketing tools, and industry support 

does not conflict with relevant Federal law. The surest way to 

eliminate commercial bias in CME is to prohibit industry sponsorship. Eliminating industry sponsorship has an—appealing for its 

purity and simplicity. As Shakespeare observed, ‘‘An honest tale 

speeds best being plainly told.’’ However, CME providers would 

need alternative funding to maintain the availability of continuing 

medical education. 

In the interim, the following measures would limit industry’s 

ability to influence the content of CME while allowing industry 

support of physician education. We suggest that pharmaceutical 

and medical device companies: (1) separate grantmaking functions 

from sales and marketing; (2) establish objective criteria for making educational grants to CME providers; and (3) eliminate any 

control over speakers or content of the educational activities. These 

measures would help ensure that funded activities are for legitimate educational purposes, and would reduce the risk that CME is 

used illegally to promote the sponsor’s products. 

Another way to limit the influence of commercial sponsors is 

through independent CME grant organizations. These entities 

could accept donations from industry and use an independent 

board of experts to distribute funds to CME providers. In effect, the 

organization would build a firewall between commercial donors and 

CME sponsors, while allowing industry to contribute to physician 

education. 

While the use of independent grant organizations has appeal, 

companies may not be willing to fund CME under its terms. If this 

proves to be the case, physicians—as do lawyers, accountants, and 

other professionals—would have to pay for their own continuing 

education. It is possible the quality of CME would improve if physicians, acting as prudent consumers, demanded more meaningful 

education for their training dollar. Ideally, the CME providers 

would respond to this change by offering higher-quality programs 

at lower cost. 

In conclusion, there is a growing concern about the integrity of 

CME and the financial relationship between commercial sponsors 

8 

and CME providers. Although restricting commercial sponsorship 

could shift the cost of CME onto physicians, such a shift could have 

a positive impact on the quality and value of CME. To preserve the 

independence of CME while allowing commercial sponsorship requires that industry donors and CME sponsors implement appropriate integrity safeguards. Whether the medical profession, 

healthcare industry, and CME providers are willing to embrace 

these measure remains to be seen. 

Thank you. 

[The prepared statement of Mr. Morris follows:] 

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The CHAIRMAN. Thank you, Mr. Morris. 

Dr. Nissen. 

STATEMENT OF STEVEN NISSEN, M.D., CHAIRMAN, DEPARTMENT OF CARDIOVASCULAR MEDICINE, CLEVELAND CLINIC, CLEVELAND, OH 

Dr. NISSEN. Thank you. I really appreciate the opportunity to 

participate in these hearings, Senators. 

My name is Steven E. Nissen, M.D. I am Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, and 

a past President of the American College of Cardiology. My testimony does not reflect the views of either Cleveland Clinic or the 

ACC. 

Continuing medical education, or CME, was originally intended 

to allow physicians to maintain professional competence and acquire new medical knowledge. In fact, most States require a minimum number of CME credits as a condition for continued licensure. 

In recent years, CME has grown into an enormous industry with 

an extraordinary influence over the practice of medicine. In 1998, 

the total income for CME was $888 million. By 2007, this had 

grown to more than $2.5 billion. Ideally, CME should provide balanced and scientifically based education designed to improve the 

quality of healthcare. Instead, CME has become an insidious vehicle for the aggressive promotion of drugs and medical devices. Amazingly, 50 percent of CME funding, about $1.2 billion, comes 

from companies who market medical products. Essentially, the 

marketing divisions of drug and device companies now dominate 

the education of physicians. 

CME has largely evolved into marketing cleverly disguised as 

education. Medical communications companies, often located in 

close proximity to the headquarters of major pharmaceutical and 

device companies, solicit funds from industry to conduct a wide variety of, quote, ‘‘educational,’’ end quote, offerings. Often, the brochures state that the program was funded via a unrestricted educational grant from the sponsoring company. However, with a wink 

and a nod, the communications company selects speakers and topics they know will please the sponsors. 

When I get these brochures, I often engage in interesting sport. 

I try to guess the sponsoring company by examining the list of 

speakers and topics. My guesses are nearly always correct. 

The lucrative CME process is also undermining the independence 

of professional medical societies, which may derive more than 50 

percent of their income from industry. Industry-sponsored CME offered through medical societies carries the risk that the imprimatur of a prestigious medical organization will be misused for 

promotional purposes. Recently, a group of current and former professional society leaders issued a statement in the Journal of the 

American Medical Association recommending that these societies 

adopt a policy of zero industry funding over the next several years. 

With billions of dollars of industry money flowing into CME, who 

is guarding the integrity of the process? Current oversight by the 

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cational activities, but appears uninterested or incapable of enforcing them. To my knowledge, few, if any, communications companies 

have lost their accreditation for biased CME. In fact, I have written 

to ACCME to complain about inappropriate CME-accredited activities. My letters were never even acknowledged. 

As a nation, we spend on healthcare at nearly double the rate 

of other industrialized countries. We use more expensive drugs and 

medical devices, even when adjusted for our national wealth. I am 

convinced that the multibillion-dollar marketing machine known as 

CME directly contributes to this excess in healthcare expenditures. 

In my written testimony, I’ve provided more details and proposed 

several congressional initiatives to reform CME. 

Thank you very much for the opportunity to speak to you. 

[The prepared statement of Dr. Nissen follows:] 

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The CHAIRMAN. Thank you very much, Dr. Nissen. 

Dr. Campbell. 

STATEMENT OF ERIC CAMPBELL, PH.D., ASSOCIATE PROFESSOR, DIRECTOR OF RESEARCH, INSTITUTE FOR HEALTH 

POLICY, MASSACHUSETTS GENERAL HOSPITAL, HARVARD 

MEDICAL SCHOOL, BOSTON, MA 

Dr. CAMPBELL. Chairman Kohl, Ranking Member Martinez, and 

members of the committee, I’m honored to testify before you today. 

Recently, I served on the Conflict of Interest Committee in Medical Research, Education, and Practice at the Institute of Medicine. 

The Conflict of Interest Committee was convened by the IOM to examine conflicts of interest in medicine, medical research, and medical education, to develop recommendations to identify, limit, and 

manage such conflicts without affecting constructive collaborations. 

My comments today will focus on the overall frequency of industry relationships and the disclosure of these relationships. I will 

also describe a set of recommendations specific to continuing medical education, that are contained in the full report of our committee. 

In terms of the frequency of industry relationships, the IOM committee carefully considered the evidence and found that industry 

relationships, and the conflicts of interest that these relationships 

create, are ubiquitous in all aspects of biomedical research, clinical 

practice, and medical education. While I will not recite the data, 

the bottom line is that it is very difficult, if not impossible, to find 

a single aspect of medical education, medical practice, or biomedical research, in which pharmaceutical and device companies 

do not create a significant risk of undue influence through the provision of capital, goods, and services. 

Because it is impossible for institutions and individuals to manage and evaluate what they are not aware of, well-functioning systems for disclosing conflicts of interest are essential. Our committee carefully considered the data regarding the various disclosure mechanisms that exist today, and concluded that they are inadequate. Our committee recommended that Congress create a national program requiring pharmaceutical, medical device, and 

biotech companies to publicly report payments to physicians, researchers, healthcare institutions, professional societies, patient advocacy groups, disease-specific groups, and the providers of continuing medical education. 

Through CME, physicians commit to lifelong learning to maintain their current skills and to develop new skills and knowledge. 

Most state licensing boards, specialty boards, and hospitals require 

accredited continuing medical education for re-licensure, recertification, and staff privileges. As we’ve heard today, presently about 

half of all funding for accredited continuing medical education 

comes from commercial sources. This substantial industry support—indirectly subsidizes physicians, who pay less for these programs than they otherwise would. The members of the IOM committee generally agreed that the accredited continuing medical education system has become far too reliant on industry funding, and 

that such support tends to promote a narrow focus on medical 

products, and neglect a broader education on alternative strategies 

23 

for preventing disease and managing health conditions, and other 

important issues, such as communication with patients and coordination of healthcare services. 

Further, given the lack of validated and efficient tools for preventing or detecting bias in educational presentations and programs, our committee concluded that industry funding creates a 

substantial risk of bias as education providers seek to maintain or 

attract industry support for future programs. Although the committee did not reach agreement on a new funding mechanism, it 

concluded that the current system of funding is unacceptable, and 

should not continue. 

As noted in recommendation 5.3, of the report—the report calls 

on representatives from key groups, including educators, certification boards, accrediting organizations, and—the public and others, to convene a consensus process to develop a new system of 

funding accredited continuing medical education that is free of industry influence, that provides high-quality education, and that enhances the public trust. 

In general, our committee believed that such a consensus process 

was likely to result in a new funding system that was feasible and 

that did not create unnecessary administrative burdens or have unintended adverse consequences. The committee left open the possibility that industry funding might be determined to be acceptable, 

under certain circumstances, with appropriate safeguards. 

In conclusion, society traditionally has placed great trust in physicians and researchers, granting them considerable leeway to regulate themselves. However, there is growing concern among lawmakers, government agencies, and the public that the extensive 

conflicts of interest in medicine require stronger measures. Our 

committee clearly believes that more transparency is necessary. 

Our committee also believes that the current levels of industry 

funding of accredited CME is unacceptable and is in need of reform. 

Thank you very much. 

[The prepared statement of Dr. Campbell follows:] 

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The CHAIRMAN. Thank you, Dr. Campbell. 

Mr. Rusley. 

STATEMENT OF JACK RUSLEY, CHAIRMAN, CULTURE OF MEDICINE ACTION COMMITTEE, AMERICAN MEDICAL STUDENT 

ASSOCIATION; STUDENT, BROWN UNIVERSITY, ALPERT 

SCHOOL OF MEDICINE, PROVIDENCE, RI 

Mr. RUSLEY. Thank you, Senators, for the opportunity to speak 

here today. 

My name is Jack Rusley, and I’m a 4th-year medical student at 

Alpert Medical School of Brown University. I’m also a national 

leader of the American Medical Student Association, or AMSA, 

where I’m the current Director of the PharmFree Scorecard, which 

is a rigorous, comprehensive assessment of industry-medicine interaction and conflict-of-interest policies at academic medical centers. 

I’m here today to tell you why my organization, and a growing 

number of physicians-in-training, believes the following: first, that 

disclosure is a first—is an important first step in bringing about 

transparency to industry-medicine interactions; next, that CME 

must be free from industry funding; and finally, that medical research must directly serve the public good over industry profits and 

physician lifestyles. Therefore, we need more high-quality, unbiased research and less marketing and freebies. 

So, with 62,000 members, AMSA is the oldest and largest independent group of physicians in training in the United States, and 

we have a long history of activism around issues in healthcare that 

affect our current and future patients. In fact, AMSA was the first 

national organization of healthcare professionals to end industry 

advertising in, or sponsorship of, all meetings and publications in 

2001. AMSA began its PharmFree campaign in 2002 to educate 

ourselves and others about the impacts of conflicts of interest. 

The first scorecard was introduced in 2007. Because of its immense success, the Pew Prescription Project has invested in this effort to help us broaden its scope. Throughout this entire time, 

AMSA has been a leader in the movement to promote evidencebased prescribing and access to medicines while preserving true 

pharmaceutical innovation. 

So, right now you may be wondering, Why do students care so 

much about these issues, and what do they have to contribute to 

the debate? As long as there have been students, there have been 

energetic young people, not yet tinged with the streak of cynicism, 

who will challenge the status quo. Most importantly, students are 

not as tangled in the financial and administrative webs as are 

many physicians, and are therefore more able to be powerful and 

passionate advocates for patients and the healthcare system we 

want to inherit, while also being free from conflicts of interest. 

A generation ago, these qualities of student activists were less 

present, and medical students were known for their docility and acceptance of authority. I’ve had the privilege to work with students 

from all over the country who have flipped this model on its head. 

Now it’s students who bring these issues to administrators, as I’ve 

done with my colleagues at Brown. 

My computer’s shutting down. Sorry about that. So, I will continue speaking off-the-cuff. 

31 

The CHAIRMAN. Thank you very much. 

Mr. RUSLEY. You’re welcome. 

I just want to recount the events that occurred at Harvard Medical School, where a group of students, similar to the ones that I’m 

speaking about, sat in class one day last spring listening to one of 

their faculty members lecture to them about a treatment for cancer. When this faculty member advocated for the use of a new, less 

researched, more expensive medication as a first-line treatment for 

this cancer, over the well-studied, effective, and cheaper alternatives, the students were a little disturbed by this, and wondered 

why. So, they actually went and Googled this faculty member, and 

found that he was actually a paid consultant of the drug company 

that produced this medication. They were concerned about this 

development, and approached their administration, which—and 

Harvard Medical School, like many medical schools, does not require faculty members to disclose conflicts of interest to students 

during lectures. So, after some negotiations, and with little 

progress, the students rallied for a call for increased transparency 

of industry-medicine interactions and an end to conflicts of interest 

at their—in their medical education. As you can imagine, this is no 

small request. Harvard is one of the most complex industry-medicine interactions in the Nation and its medical school—Harvard received a failing grade on the 2008 AMSA Scorecard because they 

had submitted no policy. 

To make a long story short, after pressure from Senator Grassley, the press, and students, Harvard has reviewed its policies, and 

now, this year, received a ‘‘B’’ on the AMSA Scorecard. 

So, I just want to reiterate that AMSA endorses the Physician 

Payment Sunshine Act, that we look for the end for industry-sponsored CME, and I just want to leave you with a pledge that Harvard students took on the steps of Memorial Hall, and that students across the country take to show our commitment to this 

issue, and it goes, ‘‘That I am committed to the practice of medicine 

and the best interest of patients, and to the pursuit of an education 

that is based on the best available evidence, rather than on advertising or promotions, I therefore pledge to accept no money, gifts, 

or hospitality from the pharmaceutical industry, to seek unbiased 

sources of information, and not rely on information disseminated 

by drug companies, and to avoid conflicts of interest in my medical 

education and practice.’’ Thank you very much. 

[The prepared statement of Mr. Rusley follows:] 

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The CHAIRMAN. Thank you, Mr. Rusley. 

One question, before I turn it over to Senator Martinez for the 

panel. The next panel will be—consist of witnesses who make the 

point that some of the things you’re making—they may contend 

that some of the statements you’re making, are overblown, and 

many of the conflicts of interest that you talk about are, by far, not 

the case, to the extent that you’re talking about them, and that the 

reforms that many of you might advocate might actually do more 

damage than good, in terms of medical education. We’ll be hearing 

from your next panel, so we’ll give you a chance, in advance, to respond to them, because you won’t have a chance to be back after 

they make their comments. 

So I’ll give you, Mr. Morris, Dr. Nissen, Dr. Campbell, and Mr. 

Rusley, just a minute to respond. Who wants to go first? Mr. Morris, you want to be first? 

Mr. MORRIS. Certainly, I’d be pleased to be. I would note that, 

from our perspective, there is a distinction between education and 

marketing. For those who want to blur the line and suggest that 

the inspector general’s office or this panel is against educating doctors, I think that mischaracterizes our concern. 

Our concern, or at least the concern from which I speak, is that 

what is presented as education is disguised marketing, and is biased and misleads the physician. So, it would be a 

mischaracterization of our view that we are against educating doctors. We strongly favor that. 

We also appreciate there’s a role for marketing. But the audience 

should understand the difference. The physician should know that 

one is marketing, and they can bring a certain level of skepticism 

to it, and the other is education, and they should trust the educator. 

The CHAIRMAN. Dr. Nissen. 

Dr. NISSEN. I think the problems are really self-evident. If you 

did a Google search for CME, for all the CME programs that teach 

physicians on how to use generic drugs to save their patients 

money, I don’t think you can find any. 

So, the problem we have is that the people paying the bills are 

determining what the topics are that are actually being used in 

education. Those topics invariably involve expensive, either hightechnology devices, imaging devices, drugs, whatever. So, when you 

think about the fact that more than half of the prescribing in 

America is actually for generic drugs, and yet there’s no education 

around generic drugs, I think you get an idea of how those biases 

increase the cost of medical care and lead to the over-use of therapies that—probably should be using—— 

The CHAIRMAN. All right. 

Dr. Campbell, you want to make a comment? 

Dr. CAMPBELL. Our committee spent over a year reviewing the 

evidence—not anecdote, not allegation, but published evidence—regarding the frequency of industry relationships in all aspects of 

medicine, research, and medical education, and they are ubiquitous. They exist in almost every single aspect—as I said before, 

it’s hard to find somewhere where they don’t exist. 

The committee also notes that these relationships have benefits, 

but these relationships also carry substantial risks, and it is underVerDate Nov 24 2008 14:39 Mar 12, 2010 Jkt 000000 PO 00000 Frm 00042 Fmt 6633 Sfmt 6633 H:\DOCS\54884.TXT SAG PsN: JOYCE
39 

standing the nature of the balance of the risks and benefits that 

is important today. Our committee supports disclosure; disclosure, 

in and of itself, does not say relationships are good or bad, they 

simply say they should be made public, so that people can understand them and evaluate them. Our belief is the fact that, essentially, one can’t manage or evaluate what one doesn’t know about. 

The CHAIRMAN. All right. 

Mr. Rusley, you want to make a comment? 

Mr. RUSLEY. Yes. I would just also advocate for education, starting in medical school, around these issues, and talking to students 

about how the industry and medicine interaction works, particularly when it comes to critical evaluation of research, so that when 

students become physicians and are out evaluating CME, and participating in it, that they can make informed choices and informed 

decisions about what to believe. 

The CHAIRMAN. OK. 

Senator Martinez. 

Senator MARTINEZ. Thank you, Mr. Chairman. 

Some of this comes as a real surprise to me, because, as a lawyer, which immediately makes me suspect to this kind of medical 

group, I went to continuing legal education. I had to do it in order 

to maintain my license. I also participated as a lecturer, many 

times, never got paid by anyone. I guess only maybe book salesmen 

would have been interested in promoting seminars. So, it comes as 

a real surprise, the level of underwriting that goes on by providers 

and suppliers of continuing medical education. It would seem to 

me—and perhaps this would be harmful to continuing education, if 

there’s not another source of funding—but would it be a good idea 

to simply not have CME that was funded by anyone other than the 

participants or the AMA or whatever other subset of medical group 

might be interested in providing it? 

Related to that, could there then be a separate type of event, 

where a pharmaceutical company says, ‘‘Come and enjoy a nice 

weekend, and I’ll tell you about my product?’’ I mean, separate the 

two. What’s education is education. Marketing can also be partially 

education, but wouldn’t they be better if they were separate and 

apart? Seems simple. 

Dr. NISSEN. I couldn’t have said that any better myself. I mean, 

I think you make an extremely powerful point, that we need a firewall between marketing and education. Right now they’re blended 

together, and the problem is, you never know quite where the 

boundary is. 

So, you know, I wandered into a CME program—often they’re 

free, so you don’t have to pay for it—and literally had to walk out 

because the bias was so terrible that it was just—you know, something that was unacceptable to me. So, at least if a physician goes 

to something that they know is marketing, that they know what 

they’re getting in for—the problem now is that they—physicians 

will go to programs which are marketed as CME, and think that 

it’s unbiased education, when, in fact, it’s not unbiased at all. So, 

I do think a firewall is a very good idea. 

Now, what it means is that some of these programs would be not 

as lavish. You know, they won’t have these multicolor brochures 

and all the kind of extras that are there. Well, that’s not really 

40 

what education’s about. It’s about content. I think you can offer 

very high content without spending the hundreds of millions of dollars that’s spent for these very fancy programs. 

Dr. CAMPBELL. Senator, it’s my own opinion, not the opinion of 

the committee, but I want—I just want to point out to you that the 

primary rationale that we use for paying resident physicians almost poverty wages in America when they work in hospitals during 

their training is that they are accruing human capital, and it’s that 

investment in their education for which they will financially benefit 

later on. In other words, they work for low wages because they’re 

learning something, and they will ultimately benefit from those 

when they go out and practice medicine. We don’t—— 

Senator MARTINEZ. Maybe not in the future. That’s been the case 

in the past. 

Dr. CAMPBELL. Right. 

Senator MARTINEZ. I’m not so sure about the future. 

Dr. CAMPBELL. Right. But, we don’t actually apply that rationale 

to continuing medical education, where it could—you could make 

the same argument that physicians need to invest in their own 

education, because they are accruing the capital. 

Mr. MORRIS. One last point. There certainly are physicians, particularly those just coming out of medical school, saddled with 

enormous debt; and there are those who—perhaps serving in rural 

communities—who are struggling to make ends meet. It is possible 

to set up independent grant organizations that could take money 

from industry and appropriately allocate it to those who need subsidy for their education. But, have educational grants controlled by 

those who don’t have skin in the marketing game, have it run by 

people whose interest is advocating for the interest of the patient 

and the physician, and have it removed from the marketing side 

of the house. 

The CHAIRMAN. Senator Franken. 

Senator FRANKEN. Thank you, gentlemen. 

Dr. Nissen, you were talking about the ACCME, which is the accreditation organization and basically you were saying that they 

can’t seem to monitor this properly. Why is that? 

Dr. NISSEN. You know, I really don’t understand. I think that 

perhaps they don’t have the resources, perhaps they don’t have the 

will. You know, historically this was not an area that got a lot of 

scrutiny. I will look forward to hearing their testimony, but I can 

assure you that a considerable amount of CME that any objective 

observer—I mean, anyone objective—would look at and say, ‘‘This 

is marketing’’—it goes on, it is not restricted in any way; you know, 

these companies continue to do this. Frankly, even some of the 

CME produced by academic organizations and professional societies 

is highly biased. So, whatever the ACCME is doing, it has really 

been ineffective. That’s why, in my written statement, I propose 

that we need a new system. We need the ACCME to go away, and 

we need to replace it with something else. Now, what that is, I 

think we’ve got to think about. But, it needs to be able to have the 

authority, but also the will, to police this. 

I think a better and easier solution is Mr. Martinez’s solution, 

which is to have a firewall, and say, ‘‘We’re going to separate marketing from education. We’re not going to mingle the two,’’ and 

41 

then you don’t need an ACCME, because marketing is unrestricted, 

you can do whatever you want; but CME is never going to be industry-funded. 

Senator FRANKEN. You and Dr. Campbell and—is it Mr. Morris, 

or Doctor? 

Mr. MORRIS. Mr. Morris. 

Senator FRANKEN. Mr. Morris—all used the word ‘‘firewall.’’ Let 

me see if I understand that. Mr. Morris, you were talking about the 

drug companies actually funding this, but putting into a pool of 

money, and then someone else would organize the CME. Is that 

correct? 

Mr. MORRIS. Yes. 

Senator FRANKEN. I think you also said you don’t know if that 

would work—— [Laughter.] 

Because you don’t know if the drug companies would do it, then, 

right? 

Mr. MORRIS. There is—I mention this in my written testimony 

there have been some attempts to create these independent grant 

organizations. One was founded by the American Academy of 

Orthopaedic Surgeons, and it has not received any grants from industry. So, the question is, If you build it, would they come? 

Senator FRANKEN. Is there any benefit from the situation, anything good that can be said of the way CME is funded by the drug 

companies—other than a nicer hotel and shrimp? Is there some 

kind of synergy between doctors and these drug companies or medical device companies, or anything that can be said, positive, about 

this? 

Dr. NISSEN. There is good CME, and—you know, 100 percent of 

the industry-sponsored CME is not bad. Let me give you at least 

one example that I mention in my written testimony. Sometimes, 

academic medical centers will put on a course, and they’ll go to a 

dozen different companies and ask for small contributions from 

each of them to fund this educational program. Very good firewalls 

in place. It’s often not about specific drugs or specific uses. Frankly, 

I’ve been to some of those programs, and I thought they were really 

pretty good. But, what they did is, they avoided this one-to-one relationship, where a company, from its marketing budget, funds 

somebody to do CME about their product. The minute that happens, you lose the objectivity. It becomes biased. Most of the time, 

if you go to those programs, what you hear is subtly, or not so subtly, organized to try to get people to use the product. 

But, I think there are some examples where it’s done well. Unfortunately, it’s not the majority. 

Senator FRANKEN. But, the conclusion of all of you is that this 

practice, of industry-funded and specific industry-funded CME 

drives up the cost of medicine in this country? 

Dr. NISSEN. I think it’s a huge driver. Let me tell you what 

the—what the data is. We spend $90 billion a year, on drugs and 

nondurables, above what would be expected for our per-capita national wealth. Much of that is due to two things. One is, drugs cost 

more in America, as I think you all know—about 50 percent 

more—but, we use a different mix of drugs. We use much more 

branded, expensive drugs than other countries do. 

42 

Now, the Senate and House are looking for $600 billion over the 

next 10 years to take care of healthcare reform. I’m telling you that 

we’re spending $90 billion a year more on drugs and nondurables 

than we should be spending. That’s $900 billion over the next 10 

years. So, if we’re right—and I believe that we are—that this machine for getting physicians to prescribe the most expensive medicines, or use the most expensive devices, is skyrocketing healthcare 

costs, that’s one of the ways we can pay for healthcare reform. That 

is why this is such a critical issue. 

Senator FRANKEN. So, when the healthcare reform debate takes 

place, and there are some Senators, like myself, who think that the 

money to pay for this is actually there in the system, that if we 

do this right, we can save enough money to cover everybody, that 

that seems to conform with what you think. 

Dr. NISSEN. Specifically, if you look at our national expenditure 

on healthcare, adjusted for our per-capita GDP, overall—not just 

for drugs and nondurables, but overall—it’s $650 billion a year 

more that we’re spending than we should compared to, say, Canada, Germany, France, and other countries with relatively similar 

national wealth. So, that’s $6 trillion over the next 10 years. 

It drives me crazy to hear all this talk about, ‘‘We can’t pay for 

healthcare reform.’’ We can pay for healthcare reform, but we’ve 

got to get on top of the overuse of expensive therapies in place of 

therapies that actually may work better and cost a whole lot less. 

Senator FRANKEN. Thank you. 

Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you very much, Senator Franken. 

We thank you so much, gentlemen on the first panel, you’ve been 

very forthcoming, very honest, very frank, and shed a lot of light 

on the topic. So, your being here today is well worth your time and 

effort, and certainly does help us in our deliberations. 

Thank you. 

We’ll now go to the second panel. We have three doctors on the 

second panel. The first witness will be Dr. Thomas Stossel. Dr. 

Stossel is currently the Director of the Division of Translational 

Medicine and a Senior Physician at Brigham & Women’s Hospital, 

as well as an American Cancer Society professor of medicine at the 

Harvard Medical School. 

The next witness will be Dr. James Scully, who is the Medical 

Director and CEO of the American Psychiatric Association, a medical specialty organization representing over 38,000 members. 

Finally, we’ll be hearing from Dr. Murray Kopelow. He is the 

Chief Executive and Secretary of the Accreditation Council for Continuing Medical Education, where he leads the organization’s efforts to certify standards for continuing medical education. 

We thank you, gentlemen, for being here today, and, Dr. Stossel, 

we’ll take your testimony. 

43 

STATEMENT OF THOMAS STOSSEL, M.D., TRANSLATION MEDICINE DIVISION AND SENIOR PHYSICIAN, HEMATOLOGY DIVISION, BRIGHAM & WOMAN’S HOSPITAL, HARVARD MEDICAL 

SCHOOL, BOSTON, MA 

Dr. STOSSEL. Thank you, Mr. Chairman, and I’m honored to participate in this important hearing. 

Since I’m pushing 68 years of age, I know I’m before the right 

committee. I’ve been in medicine for a long time, over 40 years. 

From that experience, I can say that medicine is incomparably better than when I got into it. 

It’s hard to imagine that when I was an intern, in 1967, heartattack patients languished on my ward, in bed for a month—imagine what that would cost—and left hospital with damaged, poorly 

functioning hearts. Now, when my father had a heart attack, 15 

years ago, he was in and out of the hospital in a few days, and he 

did just fine. Today it would even be better, and faster; and because of continuing education, more patients so benefit. 

Now, statistics bear out this personal perspective. Deaths from 

cardiovascular disease are down by 50 percent. Since the death 

rate remains one per person, if the number-one killer—heart disease—doesn’t get you, you sign up for the number-two—cancer. 

But, cancer death rates are at an all-time low. We have done something right in American medicine. What is right is not that doctors 

became more altruistic, ascetic, ethical, or better regulated; it’s because of the tools provided by the private medical-products industry. 

Knowledge flows back and forth between the bedside and the laboratory. This flow promotes innovation and its proper application 

to patient care. For this reason, physician-industry collaboration is 

essential in all aspects of medical innovation and education. The 

synergy, Senator Franken, is huge. 

Given this fact and the track record of value creation, the energy 

we are expending on financial conflicts of interest has been incomprehensible to me. How could we have made so much progress if 

business simply promotes salesmanship over substance and corrupts greedy, gullible physicians? 

But, such accusations are rampant and are imposing damaging 

barriers to constructive physician-industry collaboration in innovation and education. We’d better have pretty good evidence to tamper with a system of innovation and education that’s done so much 

good. 

But, the evidence justifying this tampering is extraordinarily 

weak, and I didn’t hear anything today that changes me from that 

opinion. What passes for evidence is the relentless reiteration of inevitable, sometimes, egregious, but vanishingly uncommon, adverse 

events, without reference to the tens of thousands of actions that 

lead to valuable products and much better patient outcomes. 

The plural of anecdote is never data. Lacking substantive data, 

the case for tampering is based on speculation, inference, and 

moral bullying. We heard a lot of that from the first panel. To focus 

on who pays whom how much, rather than on the quality of the 

work product, is not evidence. There is no conflict between learning 

and earning. I heard very definite statements about, ‘‘I know this 

44 

is not objective, this is biased.’’ I’ve never seen a study that has actually demonstrated such conclusions formally. 

The tampering has produced no documented benefits. It causes 

harm. Commercial support for continuing medical education’s fallen 20 percent since last year. This decline hurts physician education, especially out in the countryside. Postgraduate medical 

training slots—something Mr. Chairman, I believe you’ve expressed 

concern about—are down, too, because of rules against commercial 

funding of such positions. Prohibitions against researchers owning 

equity in startup companies, where innovation begins, chases investment away. 

All said and done, what matters is, Do patients benefit from physician-industry collaboration, as we’ve seen it? History absolutely 

attests that the answer is in the affirmative. 

Now, medicine’s come a long way in my lifetime, but it has a long 

way to go. After surviving his heart attack, my father went on to 

develop Alzheimer’s disease. Since I’m genetically signed up for 

that fate, I want to see innovation and education progress as rapidly as possible. I want to recognize my children and grandchildren 

when I die. My father could not. 

I thank you for your attention, and I hope you will accept my 

written testimony into the record. 

Thank you. 

[The prepared statement of Dr. Stossel follows:] 

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The CHAIRMAN. We will do that, sir, and thank you so much for 

what you just said. 

Dr. Scully. 

STATEMENT OF JAMES SCULLY, M.D., MEDICAL DIRECTOR 

AND CEO, AMERICAN PSYCHIATRIC ASSOCIATION, ARLINGTON, VA 

Dr. SCULLY. Mr. Chairman and members of the committee, thank 

you for inviting me here today. I am James Scully, Jr. I’m the Medical Director of—— 

Senator MARTINEZ. Would you turn on your mike, please? 

Dr. SCULLY. Now it’s on, sorry. 

Thank you, Mr. Chairman. I’m James Scully, Jr., M.D. I’m the 

Medical Director and Chief Executive Officer of the American Psychiatric Association, the medical specialty representing over 38,000 

psychiatric physicians. Thank you for inviting me today. 

By our board’s direction, our highest priority is advocating for 

our patients and our profession, and I wanted to take the time, just 

for a second, to thank you, in this past year, for passage of the parity legislation, ending a 12-year struggle to end discrimination 

against patients suffering from mental illness in our insurance programs. Thank you, Mr. Chairman, and all of Congress. I’m sure 

you would have helped too, Senator Franken, if you’d been there. 

So, we, at APA, promote the highest standards of care for our patients and families, and strive to have those same standards of excellence in psychiatric research, and in the education and training 

of our workforce. 

Many of the most dramatic improvements in the effective treatment of mental illness have come as a result of newer and better 

medications. They’ve meant remarkably positive changes in the 

lives of tens of millions of Americans, and would not have been possible without the commitment of the pharmaceutical industry, to 

research and development. We need to support continuing innovation so that these improvements can continue. The challenge is, we 

need to do this in a way that protects the integrity of our association, our members while we continue to support innovation. 

Over the past years, the relationship between medicine and industry, including pharmaceutical and device manufacturers, has 

been under increased scrutiny, and appropriately so. Patients need 

to be able to rely on the objective recommendations of their physicians. In turn, physicians need to be able to rely on the objectivity 

of research as it pertains to how they’re going to safely and effectively use the medications and devices. 

Recognizing the necessity of managing potential conflicts of interest, we’ve been looking—proactively—in examining our relationships with the pharmaceutical industry. We’ve taken considerable 

pains to implement safeguards to reduce the risk of these conflicts 

of interest between industry and the provision of continuing medical education. We, in fact, received a commendation and a 6-year 

accreditation from the Accreditation Council for Continuing Medical Education for our efforts, and we’ve continued those too—but, 

the key is, as you’ve been saying, separating promotion and commercial activities from educational activities. They are seen in the 

symposia, they don’t end there. We’ve also set some rules to create 

58 

a buffer between promotional materials, commercial materials, 

product advertisements, and educational activities. 

In March of 2008, our board voted to establish a work group to 

take an even more in-depth look at our relationship with the pharmaceutical industry and, if necessary, to recommend additional 

changes in our policies. The working group submitted its recommendations last December, and among those recommendations 

for the board to review was to phaseout all industry-supported educational symposia industry-supported meals, which are a big part 

of this, at our scientific meetings. In March of 2009, the board 

voted to accept that recommendation. As far as we know, we’re the 

first professional medical society to do this, and we’ve already 

begun—we actually began a little earlier—to implement this policy. 

For example, in 2006, we had 46 industry symposia that were 

presented, out of 500 or so total programs; in 2008, the industry 

symposia went to 28; and this year, 11 such sessions. This action 

is not without real cost to us short-term, for sure. For example, this 

year we’ll lose a million and a half dollars in revenue that we 

would have otherwise had. So, there is real short-term cost that 

we’ve decided to pay. But, in the long run, we believe that the 

elimination of even the perception of undue influence and maintaining, or regaining, public trust, is well worth the cost. 

The fact that the relationships between the pharmaceutical industry and the medical profession is facing increasing scrutiny is 

not a bad thing. To the contrary, patients need to know about their 

physicians’ potential conflicts of interest, where they truly exist, 

and only then can we have confidence in the decisions about medical decisionmaking. 

As our awareness of conflicts of interest evolves, and we need 

greater clarity, doctors, and we in the professional societies, need 

to continue to re-examine the pros and cons of our relationships 

with the industry. What are the real and what are the perceived, 

not-real, conflicts? How can we manage them, eliminate them? This 

is a process that’s underway, not just with us, but, I know, with 

many, if not most, of our sister medical organizations. We are all 

currently struggling with this, how to improve. We’re pleased to be 

in the forefront of this process. 

Thank you for the opportunity to testify this afternoon. 

[The prepared statement of Dr. Scully follows:] 

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The CHAIRMAN. Thank you very much, Dr. Scully. 

Dr. Kopelow. 

STATEMENT OF MURRAY KOPELOW, M.D., MS, FRCPC, CHIEF 

EXECUTIVE, ACCREDITATION COUNCIL FOR CONTINUING 

MEDICAL EDUCATION, CHICAGO, IL 

Dr. KOPELOW. Good afternoon, Chairman Kohl, Ranking Member 

Martinez, and members of the committee. 

I’m Murray Kopelow, Chief Executive of the Accreditation Council for Continuing Medical Education. I also serve as a Special Advisor to the White House Office of National Drug Control Policy. 

Senator Kohl, in full disclosure, my daughter, Miriam, is a proud 

student at the University of Wisconsin at Madison. 

Mr. Chairman, my colleagues and I have prepared written testimony that I request be included in the hearing record. 

The CHAIRMAN. It will be done. 

Dr. KOPELOW. Senators, ACCME is the firewall between promotion and education. ACCME administers a voluntary self-regulated system for accrediting providers of continuing medical education. These regulations include the standards of commercial support, standards for independence of continuing medical education. 

As all the panelists have pointed out, continuing medical education is important to physicians and to patients. As everyone here 

has said, ACCME is committed to ensuring that accredited CME 

contributes to the quality and safety of healthcare, contains valid 

content, and is developed without the influence of commercial interests. 

Accredited CME is independent from the influence of commercial 

interests. At your request, our testimony will focus on commercial 

support, our enforcement of our standards, and how the ACCME 

is becoming more transparent and responsive to its external constituencies. 

As said, the total revenues of CME providers are about $2 billion. About half comes from the learners; the rest comes from commercial interests. During 2008 this commercial support has fallen 

by $200 million. Eighty percent of the providers accept commercial 

support in amounts that range from thousands of dollars to tens 

of millions of dollars. But, 15 percent of the providers receive 80 

percent of the commercial support. It’s not distributed equally 

across the continuing medical education enterprise. 

ACCME has taken steps to enhance its requirements concerning 

independence from commercial interests, and enhanced its enforcement of these requirements. Next month, new policy becomes effective that excludes from accreditation any entity that markets, resells, or distributes healthcare products or services. In 2008 and 

2009, we offered several policy proposals regarding the funding 

structure of CME and restricting CME’s interactions with commercial interests. These included possibly restricting commercial support to when educational need is verified by an organization free 

of commercial support, and when the CME addresses a gap in professional practice, and when CME content was from a specified curriculum, and when that CME is verified as free of commercial bias, 

much as proposed by Mr. Morris. 

66 

We proposed excluding persons that have been paid to create or 

present promotional materials from controlling the content of accredited CME. We have proposed the use of designations like ‘‘Promotional Teacher and Author-Free’’ and ‘‘Commercial SupportFree’’ to help learners and the public. We proposed the creation of 

a new entity to pool unrestricted educational donations from commercial interests. We have not yet acted on these proposals, and 

they remain on the table while a nationwide discussion about the 

impact of industry relationships continues within many organizations, including the ACCME’s member organizations. 

In the meantime, ACCME has gone on to enhance its enforcement of policy. Since 2008, our complaints and inquiries process 

closed 17 inquiries; 12 of them remain open and will be completed 

this year. We began a process to more closely scrutinize providers 

who receive a large amount of commercial support. We now have 

a Web-based system for collecting educational activity information, 

ready to be deployed. We will now implement a surveillance and 

monitoring system that will include our direct observation of activities in the field. We now require all providers found not in compliance with our standards to receive—to submit an improvement 

plan within weeks of the findings, and to demonstrate—to submit 

a demonstration of compliance and practice within 6 or 12 months. 

This process is effective in bringing about compliance with our 

standards. The number of providers being put on probation has increased to about 10 percent of accreditation decisions. 

We have 725 providers that we accredit directly, and about 1600 

providers that are accredited by 47 ACCME-approved State-based 

medical societies, including Minnesota, Wisconsin, and Florida. Because of new ACCME policy, now all these accreditors will be enforcing the same ACCME standards the same way, creating equivalency of enforcement across the nation. This enforcement is carrying over to other professions—pharmacy, nursing, and optometry—each of whom intend to enforce the same ACCME standards. 

We continue to require disclosure of relevant financial relationships of teachers, authors, and planners, and to require disclosure 

of all commercial support to learners. We have enhanced our own 

disclosure of ACCME information. This month, we began making 

public the accreditation status of providers, if a provider takes commercial support, and the accreditation findings on which we base 

our accreditation decisions. All of this is to continue to ensure independence, and to ensure that CME matters to patient care. 

Much of what I have reported to you today is new. To provide 

the resources to meet these expectations, the CME system is paying new fees to support a 50-percent increase in ACCME staff and 

a 60-percent increase in ACCME expenditures over 2007 levels. 

I would welcome your questions on these or any other issue of 

importance to the committee, and I thank you for this opportunity 

to testify. 

[The prepared statement of Dr. Kopelow follows:] 

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The CHAIRMAN. Thank you very much. 

One question for the panel, then I’ll turn it over again to Senator 

Martinez. 

Is it a fair statement, or would you agree, that continuing medical education is critical in the medical profession? It’s not cheap; 

it’s expensive. To the extent that commercial interests are providing a great deal of the funding, that’s, on the face, a good 

thing—in the sense that they’re providing all that money, as well 

as all that knowledge and experience—but we need to be sure that 

we separate all of that from any possible conflicts of interest, in 

terms of their activities. Is that—and that’s our job, and that’s 

what we’re here to talk about—is that a fair statement? 

Dr. Stossel. 

Dr. STOSSEL. I’m so glad I’m not in politics—— 

Senator MARTINEZ. Hit your mike, if you don’t mind. Yeah. Then 

we can hear your unpopular things. [Laughter.] 

Dr. STOSSEL. OK. 

Continuing education’s absolutely essential. I think the problem 

is—I come back to, What’s the quality of the product? Not, What’s 

the motive of the producer? Of course companies want to sell stuff, 

but there has been an implicit assumption that if they’re trying to 

sell, it’s bad, or it’s not the right information that patients need. 

I recently heard a young woman, who had gotten multiple sclerosis, tell her story. She explained how new products have come on 

line rapidly over the last few years to manage what previously was 

practically untreatable, nothing could be done, and now the prognosis is much better. She explained how the only way she heard 

about the most up-to-date products, which are the most effective, 

was through commercially sponsored continuing education. The 

nonprofit societies just can’t get up to speed fast enough, because 

it’s at that interface where the physicians, working with industry, 

are actually doing this innovation, know what’s going on, and can 

get that information to patients. I’ve heard it from juvenile-diabetic 

parents. It’s a very consistent message. 

The CHAIRMAN. Thank you. 

Yes, Dr. Scully? 

Dr. SCULLY. Marketing and education need to be separated. 

That’s what we’re trying to do. Senator Martinez, your comment 

about legal education hits home. I actually have more lawyers on 

my staff than I do doctors, and they point out to me all the time, 

they pay for their own CLE, why don’t doctors do that? 

I think we’re in transition now. What you’re seeing is things 

changing, as they do. We get new knowledge, we look at things, we 

say, ‘‘Geez, we need to take a look at this, maybe we’re not doing 

it the best way we can.’’ 

CME long term, in professional development, is critical for physicians. We have new knowledge all the time. It has to be part of 

doctors’ learning. There’s—no question about it. We need to do it 

as well as we can. I think doctors are going to have—and we’ve gotten acculturated to having free CME and having a good meal, free. 

That’s going to change. 

I’ll stop there. 

Dr. STOSSEL. Lawyers and doctors are completely separate, different business models. I’m sure the doctors are going to love to 

106 

hear that if—as you’re debating healthcare reform, and that their 

reimbursement may go down, that they’re going to have to pay for 

their own CME. 

The CHAIRMAN. Dr. Kopelow. 

Dr. KOPELOW. Senator, I agree with you that continuing medical 

education is critical. The literature says that it’s effective in improving practice and changing practice. Our goals are to address 

overuse, underuse, and misuse, all three of them, and to incorporate, and to assist, and promote change. 

Two weeks ago, in the Journal of the American Medical Association, there was a news story on the issues of the use of nonsteroidal anti-inflammatories in the elderly. The story was about the 

fact that the use of the nonsteroidal anti-inflammatories needs to 

go away, because they’re dangerous, and the physicians need to 

start to use narcotics to manage the pain in the elderly, instead of 

the other drugs. 

That is a complex professional change that needs to take place; 

and it needs to take place urgently, needs to take place now; it 

needs to have the interests of the patients at heart. 

The participation of the producers of the nonsteroidal antiinflammatories, and the participation of the industry that produces 

the narcotics, is reasonable and rational in—from a funding source, 

because it’s in their interests, both of their interests, for those 

products to be used properly in the aged. 

What we believe is that that education needs to be developed 

independently of those kinds of industries, from the perspective of 

content, direction, advice, and recommendations. 

We have policy about that, we have principles; the profession 

shares these ethics and values, and this is what we promulgate. 

We’re going to be able to monitor the system in order to ensure 

that the outcome of those educational activities is in the best interests of the elderly and the aged who are in pain. 

The CHAIRMAN. Thank you. 

Senator Martinez. 

Senator MARTINEZ. Dr. Stossel, I want to tell you, first of all, I 

appreciate you being here with a bit of a contrarian point of view 

from what is the prevalent point of view at the hearing, but I think 

it’s important to hear your point of view, and I think you make excellent points. 

I just wonder if there would not be a better way to continue to 

educate doctors, and understanding that, perhaps culturally or because of constraints on how doctors are compensated, perhaps doctors also paying for CME would be kind of a novel thought. Would 

you conceive that it might be better if CME was then done at medical—I mean, under the supervision, direction, or whatever, of medical colleges, place where people normally go to learn medicine? Or, 

do you think it has to be integrally connected to the industry, 

whether it be devices or pharmaceuticals? 

That’s really—I mean, you know, isn’t there another way of doing 

this that would not necessarily just go feed at the trough of those 

that are trying to promote a product? 

I understand, doctors are smart enough to see the difference. It’s 

perfectly good in America; we still believe in free enterprise, I 

think—at times I wonder, but I do think— [Laughter.] 

107 

Profit is a good motive, and marketing is a good thing. These are 

all good things. The question really is—is that interplay, and 

maybe the lack of transparency. Maybe the alternatives might also 

be equally good, and reach a good outcome, as well. 

Dr. STOSSEL. Well, you covered a lot of ground there, Senator. 

Senator MARTINEZ. Yeah. 

Dr. STOSSEL. Anything’s possible. But, in my view, I think the 

real question is, Is the system really broke? Do we need to fix it? 

It’s—if ‘‘broke’’ means ‘‘not perfect,’’ it’s broke. But, I don’t see it 

that way. I see CME as pretty darn effective, as it’s currently constituted. 

Medicine obeys the laws of physics, chemistry, biology, but it also 

obeys the laws of economics. When I hear from a patient or a family member that they get the best information from a commercial 

source, I want that best information. I don’t care who pays for it. 

Now, there’s—there is this bit of asceticism that creeps in—— 

Senator MARTINEZ. Well, you’re talking there—you’re talking 

there about advertising on TV. 

Dr. STOSSEL. No, I’m talking about—— 

Senator MARTINEZ. The ‘‘purple pill,’’ or whatever. 

Dr. STOSSEL [continuing]. That the setting and the mechanism by 

which—that in order to promote the product, the new product, that 

the physician can’t possibly learn about, because they have so 

many things to keep track of, that the companies make an effort 

to get those parties together. So, the physicians, the patients, now 

hear about these products—— 

Senator MARTINEZ. That’s not CME, though. I mean, if I’m going 

to the doctor and say, ‘‘Hey, I just heard about this, and it may 

help my problem’’—— 

Dr. STOSSEL. I think any education about—— 

Senator MARTINEZ. But, I think that’s fine. I mean, that’s patient 

education, that may be public information, marketing, advertising. 

I separate that from what is educational opportunities. 

See, I’m wondering about you, a well-intended physician who 

signs up to go to a class, to get some credits and learn something, 

and sits in the room and says, ‘‘I didn’t know this is what I was 

going to get. I didn’t come here to get a pitch. I came here to 

learn.’’ 

Dr. STOSSEL. But, I don’t think that happens, Senator. I 

think—— 

Senator MARTINEZ. You just don’t like—— 

Dr. STOSSEL [continuing]. That the—if it’s happening regularly, 

I’d like to see the evidence for it. Now, you mention transparency, 

that’s—I’m all for transparency, although I think that, as an abstraction, it’s a lot easier to deal with than what—the way it works 

on the ground. 

Senator MARTINEZ. OK. Well, thank you. 

The CHAIRMAN. I just want to—before I comment on—- Martinez, 

before we turn it over to Senator Franken—I don’t believe you’re 

saying that we can’t do what we’re doing, but do it better. I think 

you’re saying we should recognize the value of what we’re doing 

and not throw it out. But, you’re not suggesting we couldn’t do it 

better. 

Dr. STOSSEL. Can always do it better, sir. 

108 

The CHAIRMAN. All right. Thank you. 

Senator Franken. 

Senator FRANKEN. I just wanted to make a comment, Dr. Stossel, 

on a couple of things you said. 

First of all, you seem to try to draw conclusions from stories. 

Medicine is a lot better now than it was when we were kids. That 

doesn’t mean that industry should fund CME. It doesn’t follow. You 

said that accumulation of anecdotes doesn’t equal data, but you 

used anecdotes. I don’t see the connection between your testimony 

and any kind of proof about the issues that were raised. 

Now, Mr. Kopelow, I hear that you’re doing some things now, 

and I’m wondering, is this in response to the criticism that you’ve 

been hearing from our first panel, or is it just a natural outgrowth 

of what you do? 

Dr. KOPELOW. The input to the ACCME began with Senator Kennedy in the 1990’s, and our standards of commercial support, and 

our system has been responsive to what’s been going on in the profession and in Senate over the last few years. 

Senator FRANKEN. OK. I just wanted to ask one thing. You 

talked about—companies being on probation. 

Dr. KOPELOW. Yes. 

Senator FRANKEN. How long are they on probation? How long are 

they allowed to be on probation before they have to stop doing what 

they’re doing? 

Dr. KOPELOW. Well, they have to stop what they’re doing immediately, and they have to demonstrate—— 

Senator FRANKEN. What if they don’t? How long is probation? 

Dr. KOPELOW. They can be on probation up to two years. 

Senator FRANKEN. Two years? 

Dr. KOPELOW. Yes. 

Senator FRANKEN. So, they could continue doing what they’ve 

been doing for two years, without being tossed? 

Dr. KOPELOW. The issues that we’ve been hearing about today, 

no. The issues that we’ve been hearing about today, about the independence, the resolution of conflict of interest—our board, at its 

last meeting, talked about asking for demonstrations of compliance 

within 4 months, 8 months, and 10 months, and getting them off 

the rosters. 

Senator FRANKEN. OK. 

One last thing, Dr. Scully. Are you making these changes because of the perception of conflict of interest? I mean, you said 

something about—everything is—the money you’re losing is worth 

regaining the trust of the patients. Is it about the perception, or 

is it about the reality, in your view? 

Dr. SCULLY. Both. 

Senator FRANKEN. OK. Thank you. 

Thank you, all. 

Dr. KOPELOW. Senator Kohl, could I respond to—— 

The CHAIRMAN. Yes, go ahead—— 

Dr. KOPELOW [continuing]. A question of Dr. Martinez? 

The CHAIRMAN.—Dr. Kopelow. 

Dr. KOPELOW. Most of the continuing medical education in this 

country is not commercially supported. If you take all the money 

that comes into the system, it’s half. Most of the money is in a 

109 

small group of providers, and most of the continuing medical education is occurring in the hospitals, in the small county and State 

medical societies around the country, in our 1600 State-accredited 

organizations. It’s not commercially supported, it’s independent, 

and is occurring in the medical societies and in the hospitals and 

in the healthcare settings. 

The CHAIRMAN. Thank you. 

Senator MARTINEZ. But now, for that other half, you wouldn’t object to the transparency that would make it clear when the line is 

blurred between marketing and science. 

Dr. KOPELOW. Marketing—that line is not blurred in our continuing medical education enterprise. What we’ve heard about is in 

another time, in another place. But it—our accredited providers 

clearly draw the distinction and separation between promotion and 

education. 

Senator MARTINEZ. Thank you. 

Dr. KOPELOW. Thank you, sir. 

The CHAIRMAN. Yes—— 

Dr. STOSSEL. Can I respond—— 

The CHAIRMAN [continuing]. Sir, Dr. Stossel. 

Dr. STOSSEL [continuing]. To Senator Franken’s comment? 

A 50-percent drop in cardiovascular mortality is not anecdote. I 

personalized it. I think that this happened in the context of unregulated CME, excesses that existed in the past. Things have 

changed considerably in the last 10 years. The Joslin Clinic in Boston, has a very active education program. They’ve been trying to 

change physician behavior. That’s the gold standard in continuing 

education. There are people in the companies that are passionate 

about that. Sure, they’ll sell more product. But, it ultimately is 

what benefits the patient. 

Senator FRANKEN. Thank you. 

The CHAIRMAN. All right, thank you very much, gentlemen. You, 

also, have contributed a great deal to the subject, and we appreciate your taking the time and bringing us all the experience and 

knowledge that you have. 

Thank you so much. 

This hearing is adjourned. 

[Whereupon, at 3:27 p.m., the hearing was adjourned.] 

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