Tuesday, November 17, 2009

Seeking NIH to fund studies on medical ethics, conflicts of interest in medicine and research, and prescribing behavior

Adriane Fugh-Berman MD is principal investigator (PI) of the PharmedOut project. PharmedOut is an independent, publicly funded Georgetown University Medical Center project that educates physicians about industry influence on prescribing. project that empowers physicians to identify and counter inappropriate pharmaceutical promotion practices. PharmedOut promotes evidence-based medicine by providing news, resources, and links to pharma-free CME courses.

PharmedOut is requesting that the U.S. NIH (National Institutes of Health) fund more research into ethics, conflicts of interest, and prescribing behavior. One hundred researchers, clinicians, and ethicists have signed a letter sponsored by PharmedOut asking NIH to fund research on medical ethics, conflicts of interest, and industry influence on prescribing behavior. Stimulus funds have increased the NIH budget by ten billion dollars, but NIH has no mechanism for funding research on how commercial interests affect the choice of medical therapeutics.

Signers include Virginia Barbour MD, Chief Editor of PLoS Medicine, Jerome Kassirer, MD, former editor in chief of the New England Journal of Medicine, Jerry Avorn MD, the Harvard physician who invented academic detailing, Kay Dickersin PhD, Director of the U.S. Cochrane Center, and Susan Wood, PhD, former head of the FDA Office of Women’s Health Research, who resigned over political influence regarding FDA decisions on the emergency contraceptive Plan B. Institutional signers include the Public Library of Science, the American Medical Student Association, the National Physicians Alliance, Consumers Union, the Center for Science in the Public Interest, and the National Women’s Health Network.

The letter, sent to NIH today, is available at http://www.pharmedout.org/NIHLetter.pdf (PDF) and below:

Nov. 17, 2009

From: Adriane Fugh-Berman MD
Department of Physiology and Biophysics
Georgetown University Medical Center
Box 571460
Washington DC 20057-1460
Phone: (202) 687-7845
Fax: (202) 687-7407
ajf29 AT georgetown DOT edu

To: Francis S. Collins, MD, PhD
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892

Dear Dr. Collins,

We are writing to ask NIH to fund studies on medical ethics, conflicts of interest in medicine and research, and prescribing behavior. NIH funds a substantial portion of the generation and dissemination of evidence, but the uptake of that evidence and its translation into clinical practice is strongly affected by the complex web of relationships that exists among industry, academicians, medical educators and clinicians.

There is growing evidence that each strand of this web is compromised by ethical lapses and financial conflicts of interest. The recent disclosure of ghostwritten articles, physician payoffs, and the use of academic opinion leaders to increase markets for FDA-regulated products indicate that ethical lapses may permeate biomedical research. A PLoS Medicine editorial in September called ghostwriting “The dirty little secret of medical publishing” and notes “the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the health care decisions of physicians and the general public.” [1] An October 1 editorial in the Boston Globe called for a ban on industry speaker fees to physicians. [2] Last month, a commentary in JAMA called for physicians to pay for continuing medical education (CME), [3] citing a recent Institute of Medicine report [4] that criticized physicians’ reliance on industry-funded education.

A stated goal of the NIH is to “exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.” Could the muted effect that large, definitive NIH studies, including the WHI, ALLHAT, and CATIE, have had on clinical practice be due to commercial influences? To what extent have ghostwritten articles corrupted the medical and scientific literature? The extent to which industry influences the interpretation of science is unknown.

Dr. Elias Zerhouni, in the September 17th issue of Nature, commenting on Senator Grassley’s investigation of academic medical centers, said “People flouted the rules, didn’t disclose, and did it for years on end, repeatedly.” [5]

In your role as the director of “the steward of medical and behavioral research for the Nation,” we ask that you acknowledge the research gap on the effect of conflicts of interest and commercial influence on medical decisionmaking and set in motion a process that leads to recognition of the importance of funding studies on research ethics, the beliefs and behaviors of researchers and clinicians, and the effects of industry-academic relationships on the generation and dissemination of medical knowledge.

Between bench and bedside lies a path treacherous with ethical quandaries. NIH is the best place to launch and support a scientifically rigorous inquiry into the state of research ethics, industry-academic relationships, and the effect of these relationships on human health. There is currently no identifiable mechanism through which NIH would fund this research.

Your leadership regarding the importance of this issue as one the NIH needs to direct resources towards is essential. We hope to discuss these issues in a face-to-face meeting.


Adriane Fugh-Berman, MD
Associate Professor, Georgetown University Medical Center
Director, PharmedOut

ajf29 AT georgetown DOT edu

[and others whose signatures can be seen at the PDF - ed.]

[1] Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Bigger. PLoS Medicine, September 8, 2009. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000156

[2] Keep Doctors Independent; Ban Fees From Drug Makers. Boston Globe, October 1, 2009. http://www.boston.com/bostonglobe/editorial_opinion/editorials/articles/2009/10/01/keep_doctors_independent_ban_fees_from_drug_makers/

[3] Campbell EG, Rosenthal M. Reform of Continuing Medical Education: Investments in Physician Human Capital. JAMA. 2009;302(16):1807-1808.

[4] Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; April 28, 2009. http://www.iom.edu/CMS/3740/47464/65721.aspx

[5] Wadman M. The Senator’s sleuth. Nature. 2009 Sept;461(17):330-4.

This letter caught my eye, and I expressed support as follows, adding an additional angle to Dr. Fugh-Berman's letter:

Dear Dr. Fugh-Berman,

As a blogger at Healthcare Renewal, I will enthusiastically sign on to and endorse your letter calling on NIH to fund more research into ethics, conflicts of interest, and prescribing. I also wish to add an extended point:

The issues of ethics and conflict of interest also affect healthcare information technology (HIT), and ultimately physician practice. HIT applications are experimental medical devices now being pushed upon physicians via the Office of the National Coordinator and HHS. These medical devices are soon to undergo regulation as such in the EU (pdf report from the Swedish Medical Products Agency here), Canada, the U.S. and other countries as well.

They are used in patient care without patient consent. Their use holds significant potential to monitor and enforce practices deemed appropriate by whomever has the most influence on the bodies controlling the use of these technologies and the data they generate.

From that perspective, and from the perspective of the 2009 National Research Council report that calls for accelerating interdisciplinary research in biomedical informatics, computer science, social science [i.e., the social and ethical implications of health IT], and health care engineering as a sine qua non of health IT success, I believe it is time for NIH to take a leadership role in regulating these devices, conflicts of interest in the health IT industry, and the ethics of their use.

I perhaps should have written "I believe it is time for NIH to take a leadership role in sponsoring research on regulating these devices, conflicts of interest in the health IT industry, and the ethics of their use", rather than calling on NIH to be a regulator. However, until the regulatory affairs concerning health IT are in order, I felt the stronger statement appropriate.

-- SS


Anonymous said...

Dr. Fugh-Berman is going to have an uphill battle as outlined in two recent articles. In the NYT article: House members' language mirrors that of lobbyists by Robert Pear we find:

"Statements by more than a dozen lawmakers were ghostwritten, in whole or in part, by Washington lobbyists working for Genetech, one of the world largest biotechnology companies.

Genentech, a subsidiary of the Swiss drug giant Roche, estimates that 42 House members picked up some of its talking points - 22 Republicans and 20 Democrats, an unusual bipartisan coup for lobbyists."

Moving on to the WSJ Health-Bill Disclosure Rule Is Resisted by Alicia Mundy we find:

"The vast majority of industry funded CME programs are simply infomercials for the funding company's latest drug or device said Daniel Carlat.

Industry funding for continuing medical education in general, including seminars held by nonprofit groups and hospitals, dropped 14% in 2008 to $1billion, according to the Accreditation Council for Continuing Medical Education. It said industry payments to for-profit firms dropped 22% to $463 million in 2008 from $594 million a year earlier.

Medtronic Inc., which makes heart stents, paid $802,791 to sponsor eight 2007 Rockpointe seminars on "controversies in stent therapy."

Earlier this year, Senate committees released documents showing that a joint venture of Schering-Plough Corp. and Merck & Co. paid $60 million between 2004 and 2008 for continuing education courses on heart disease."

Pharma's corporate culture of controlling both the message and the controls on that message are well in place. The concept that they could have identical statements placed in the Congressional Record are unthinkable until the reality that this has happened is discovered.

To think that industry funded CME has dropped to only $1B is impossible to fathom. Remembering that this $1B has purchased focused presentations aimed at KOL and other leaders able to influence the use of their products.

The time for push back is long over due. The problem is will the political leadership limit the use of the funds sought by
Dr. Fugh-Berman, so as not to dry up their own pharma funding?

Steve Lucas

InformaticsMD said...

"Statements by more than a dozen lawmakers were ghostwritten, in whole or in part, by Washington lobbyists working for Genetech, one of the world largest biotechnology companies.

Now ghostwriting extends to our politicians - incredible.

Thanks for that reference.

-- SS