[Senate Hearing 111-305]
[From the U.S. Government Publishing Office]



                                                        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





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                       SPECIAL COMMITTEE ON AGING

                     HERB KOHL, Wisconsin, Chairman
RON WYDEN, Oregon                    MEL MARTINEZ, Florida
BLANCHE L. LINCOLN, Arkansas         RICHARD SHELBY, Alabama
EVAN BAYH, Indiana                   SUSAN COLLINS, Maine
BILL NELSON, Florida                 BOB CORKER, Tennessee
ROBERT P. CASEY, Jr., Pennsylvania   ORRIN HATCH, Utah
CLAIRE McCASKILL, Missouri           SAM BROWNBACK, Kansas
SHELDON WHITEHOUSE, Rhode Island     LINDSEY GRAHAM, South Carolina
MARK UDALL, Colorado                 SAXBY CHAMBLISS, Georgia
KIRSTEN GILLIBRAND, New York
MICHAEL BENNET, Colorado
ARLEN SPECTER, Pennsylvania
AL FRANKEN, Minnesota
                 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)

  


   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.
    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.
    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.
    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 ensure that we're doing all that we 
can to educate healthcare providers 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 College of Cardiology, the professional society 
representing American 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.
    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 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:]
    
    [GRAPHICS NOT AVAILALBLE IN TIFF FORMAT]
    
    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 Accreditation Council for Continuing Medical 
Education, or ACCME, is ineffective. The ACCME has strict rules 
governing educational 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:]

    
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
        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 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 
evidence-based 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.
    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 high-technology 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 understanding 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 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 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.
    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.

    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, 
heart-attack 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 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 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.
    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 
Support-Free'' 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 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 
anti-inflammatories, 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.]
    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.
    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 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.]
                            A P P E N D I X

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