For at least six years, we have called for the restoration of an impenetrable firewall between academic medicine and Big Pharma / biotech industry–so that industry’s influence will not corrupt medical research and, by extension, medical practice. At last, a prestigious consensus panel of the Institute of Medicine as a Profession (IMP) has faced up to the fact that commercial interests pose a "serious threat" to the integrity of medicine and patient safety.
"Marketing and market values should not be allowed to undermine physicians’ commitment to their patient’s best interest or to scientific integrity," says the working group, which was co-funded by the ABIM Foundation and the Institute on Medicine as a Profession (IMAP). The group recommends that academic medicine must take the lead and abolish or strictly regulate gifts and payments that unduly influence physicians."
The panel, co-chaired by Troyen A. Brennan, MD, JD, MPH, President of the Brigham and Women’s Physician Organization, and David J. Rothman, PhD, President, Institute on Medicine as a Profession; Professor of Social Medicine, Columbia University Medical Center, includes Jordan J. Cohen, MD, President, Association of American Medical Colleges, and Jerome P. Kassirer, MD, former editor of The New England Journal of Medicine, who is now, Distinguished Professor and Special Assistant to the Dean, Tufts University School of Medicine.
The consensus panel is calling for a ban on the intermingling of industry and academic scholars and physicians:
*Banning Gifts. * Barring direct drug samples. * Centralizing funds for physician travel and consulting. * Insulating CME. * Restricting Formulary Ties. * Speaking and Writing Bans. * Research Contract Transparency.
Members of the working group acknowledge that their recommendations will meet some resistance but they say these changes would enhance the values of medical professionalism. If institutions such as Harvard University, and Columbia University and the University of California would take the lead and divest themselves of industry’s tentacles , the others will follow, if only out of shame.
Question is: when will the Institute of Medicine of the National Academies of Sciences join the initiative?
Contact: Vera Hassner Sharav
Institute on Medicine as a Profession
For More Information, Contact:
Janet Firshein, Jacquelyn Flowers, or Susan Laine at 301-652-1558
EMBARGOED FOR RELEASE ON
Tuesday, January 24, 2006, 3 p.m. Central, 4 p.m. ET
CITING "A SERIOUS THREAT" TO MEDICAL PROFESSIONALISM, NATIONAL HEALTH LEADERS URGE TEACHING HOSPITALS TO "PUT PATIENTS FIRST" BY ABOLISHING GIFTS, PAYMENTS THAT UNDULY INFLUENCE PHYSICIANS
CONSENSUS REPORT SAYS CONFLICT OF INTEREST IS ERODING MEDICAL PRACTICE; RECOMMENDATIONS ARE FIRST TO DEMAND SWEEPING BAN
ON MARKETING ACTIVITIES
(New York, NY and Philadelphia, PA) – Calling it "a serious threat" to medical professionalism, a group of prestigious medical leaders today urged the nation’s
academic medical centers (AMCs) to exert tighter control on ties between physicians and drug and device makers. These ties, they declare, are eroding the scientific
integrity of medicine and hurting patients. In a series of recommendations published in the January 25 issue of the Journal of the American Medical Association (JAMA),
a working group of physician and academic leaders agree that previous attempts by drug companies, medical societies and the federal government to control marketing
activities have been largely ineffective. None of them establishes monitoring mechanisms or pinpoints responsibility for compliance.
"Marketing and market values should not be allowed to undermine physicians’ commitment to their patient’s best interest or to scientific integrity," says the working
group, which was co-funded by the ABIM Foundation and the Institute on Medicine as a Profession (IMAP). The group recommends that academic medicine must take
the lead and abolish or strictly regulate gifts and payments that unduly influence physicians. This would include barring the direct provision of drug samples,
banning gifts of any size, and excluding physicians with financial ties from prescription drug formulary decisions. Since drug companies spend an average
of $13,000 a year per doctor on marketing activities, the costs of which are reflected in drug prices, these proposals might well reduce the price of medicines.
"The data are overwhelming. Gifts, travel grants, consulting contracts, support for Continuing Medical Education (CME) and speaking fees affect which drugs doctors
prescribe for their patients," says David Rothman, Ph.D., president of the IMAP and co-chair of the working group. "The system has to change, and no one is in
a better position to affect change than the academic medical center."
IMAP is a think tank that promotes medical professionalism through a center at the Columbia University College of Physicians & Surgeons in New York City (<http://www.imapny.org>).
The ABIM Foundation is an operating foundation based in Philadelphia that is committed to advancing professionalism and physician leadership in quality.
"It’s clear that voluntary disclosure is not working and even small gifts can influence behavior," says Troyen Brennan, MD, JD, co-chair of the group and president
of the Brigham and Women’s Physicians Organization in Boston. "We’re trying to appeal to a physician’s sense of professionalism that current approaches to curing
conflicts of interests are no longer defensible. The profession must exert tighter control over the relationships between manufacturers and physicians."
The frustration with the weakness of current guidelines is shared by the working group (see attached list), which includes some of the most respected medical and academic thought leaders in the country, including Jerome Kassirer, MD, former Editor-In-Chief of the New England Journal of Medicine; Jordan Cohen, MD, president of the Association of American Medical Colleges; and David Blumenthal, MD, director of the Institute for Health Policy at Massachusetts General Hospital.
The working group spent two years reviewing industry marketing practices and literature on the effect of marketing influences on physician decision making.
The group reviewed their proposals with medical school leaders and drug company officials. Their recommendations go significantly beyond previous guidelines
and systematically address the threat to physician professionalism – defined as a commitment to altruism, to putting patients’ interests first, to scientific
integrity, and to an absence of bias in medical decision making.
The authors point to several recent incidents where major drug manufacturers have funded education initiatives and grants for products while withholding negative
information about side-effects and other problems. Full disclosure might have reduced sales but would have protected patients.
Specifically, the group’s policy proposal recommends:
* Banning Gifts. Drug and device makers should be prohibited from giving physicians all gifts, including free meals, payment for travel, and payment for participating
in CME. The gift ban also eliminates a major entry point into doctors’ offices by industry salespeople.
* Barring direct drug samples. The direct provision of pharmaceutical samples to physicians should be replaced by a system of vouchers for low-income patients
or other indirect distribution systems to distance company marketing from physicians.
* Centralizing funds for physician travel and consulting. AMCs should establish a central office or facility, free of influence or conflict, to accept funds
for travel and consulting time and to dispense the funds at its discretion.
* Insulating CME. There should be a firewall set up between CME activities and direct industry support. Manufacturers who want to fund educational activities
should contribute to the AMC’s central office, which would then disperse funds. This approach would enable the recipient to remain free from influence by any
one donor company.
* Restricting Formulary Ties. Physicians with financial relationships to drug and medical device manufacturers should be excluded from hospital and medical
group formulary committees and committees overseeing purchases of medical devices. This would include physicians who receive any gift, inducement, grant or contract
from the company.
* Speaking and Writing Bans. AMC faculty should not participate in speaker’s bureaus for pharmaceutical or device makers and should be banned from publishing articles
or editorials that are ghostwritten by industry employees.
* Research Contract Transparency. To ensure scientific integrity, more transparency and open communication in consulting and research grants is needed. Open-ended
grants or gifts to individual researchers should be prohibited. Consulting and research contracts should be posted on a publicly available website.
The working group’s recommendations come at a crucial time. Drug maker marketing practices are falling under increasing scrutiny by state and federal policymakers
in the wake of the Merck/Vioxx case and others. A recent congressional investigation of the money that drug companies give as educational grants, for example, found
that the payments are growing rapidly and marketing executives sometimes steer payments to physicians and groups that push unapproved uses of the drugs.
Members of the working group acknowledge that their recommendations will meet some resistance but they say these changes would enhance the values of medical
professionalism. As Rothman notes: "Decisions would be more evidence based, less biased and more objective, resulting in better outcomes for patients. Academic
medical centers and physician groups would live by a standard set of rules across the board, and above all, the medical profession would confirm a very public
commitment to put patients’ interests first."
"The timing is right for this," adds Rothman. "We are saying to academic medical centers ‘Clean up your act. If you don’t, others will.’"
For a copy of the January 25 article, "Health Industry Practices That Create Conflicts of Interest – A Policy Proposal for Academic Medical Centers," the
media can email firstname.lastname@example.org <mailto:email@example.com> or call 312-464-JAMA.
For more information on the Institute on Medicine as a Profession and a copy of this press release, visit <http://www.imapny.org>
Mmbers of the Working Group
Troyen A. Brennan, MD, JD, MPH, President of the Brigham and Women’s Physician Organization
David J. Rothman, PhD, President, Institute on Medicine as a Profession; Professor of Social Medicine, Columbia University Medical Center
Linda Blank, Robert G. Petersdorf Scholar-in-Residence, Association of American Medical Colleges
David Blumenthal, MD, Director, Institute for Health Policy, Massachusetts General Hospital
Susan C. Chimonas, PhD, Research Scholar, Institute on Medicine as a Profession
Jordan J. Cohen, MD, President, Association of American Medical Colleges
Janlori Goldman, JD, Research Scholar, Institute on Medicine as a Profession; Director, Health Privacy Project
Jerome P. Kassirer, MD, Distinguished Professor and Special Assistant to the Dean, Tufts University School of Medicine
Harry Kimball, MD, Senior Advisor to Dean, University of Washington School of Medicine
James Naughton, MD, Associate Clinical Professor, University of California, San Francisco
Neil Smelser, PhD, University Professor Emeritus, University of California, Berkeley