Medical Schools Should Ban Drug Company Gifts, Samples, Contributions To Continuing Education, JAMA Paper States

Main Category: Medical Students / Training
Article Date: 26 Jan 2006 - 13:00 PDT

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Gifts, free samples and other promotional incentives given to doctors by pharmaceutical companies and medical device manufacturers undermine medical care and should be prohibited, a group of doctors wrote in an article in Wednesday's Journal of the American Medical Association, the New York Times reports (Harris, New York Times, 1/25). According to the Washington Post, the article is one of a series published in JAMA this week concluding that "strict, standardized policies are needed to ensure patients receive unbiased, evidence-based treatments" (Connolly, Washington Post, 1/25). According to the authors -- who include doctors from Harvard University, Columbia University, the Association of American Medical Colleges and the Institute on Medicine as a Profession -- the pharmaceutical industry spends about 90% of its $21 billion annual marketing budget on promotions for doctors (Rubin, USA Today, 1/25). Gifts range from consulting arrangements for hundreds of thousands of dollars to free drug samples and small gifts of pens, mugs and working lunches. Pharmaceutical companies are forbidden by law to pay doctors to prescribe drugs or devices, but "gifts and consulting arrangements are almost entirely unregulated," the New York Times reports. Voluntary professional guidelines suggest that doctors not accept gifts of greater than "modest" value (New York Times, 1/25). However, such guidelines are ineffective, the authors write, adding, "Marketing ... should not be allowed to undermine physicians' commitment to their patient's best interest or to scientific integrity" (USA Today, 1/25).

Recommendations
According to the article, existing guidelines should be replaced with more stringent policies that prohibit gifts, restrict corporate financial ties and require "transparency in medical research contracts," the Los Angeles Times reports (Girion, Los Angeles Times, 1/25). The authors recommend that medical schools and teaching hospitals be the first to establish a comprehensive ban, followed by the rest of the medical profession (New York Times, 1/25). They recommend that medical schools:

• Ban all gifts, including free working lunches;
  


• Prohibit doctors from accepting free samples, which the authors call a "powerful inducement ... to rely on medications that are expensive but not more effective";
  


• Prohibit doctors with financial ties to pharmaceutical companies from serving on panels that recommend which drugs should be prescribed;
  


• Ban medical school faculty from participating in companies' speakers bureaus or publishing articles ghostwritten by pharmaceutical industry officials;
  


• Require medical school faculty with industry consulting agreements or unconditional grants to post them on a publicly available Web site;
  


• Prohibit pharmaceutical companies from directly paying for continuing medical education classes (USA Today, 1/25);
  


• Establish a system under which pharmaceutical and device manufacturers would contribute to a central account that would support educational programs; and
  


• Create a voucher system or central distribution bank to which pharmaceutical companies would donate drug samples to give to low-income patients (Washington Post, 1/25).
  

Comments
"This paper represents a call to action," co-author David Rothman, a professor at Columbia and president of the Institute on Medicine as a Profession, said (USA Today, 1/25). He added, "Drug companies spend $13,000 per physician annually. Those marketing tactics are very, very effective at getting physicians to do what each drug company wants -- to prescribe their product." Co-author Jordan Cohen, president of AAMC, said, "We've become overly dependent on these kinds of blandishments to support our core activities, and that is jeopardizing public trust and scientific integrity" (Washington Post, 1/25). Cohen said he plans to discuss the article with AAMC's executive council but added that he expects "resistance" from universities and doctors concerned about losing income in the wake of such a ban (Wilde Mathews, Wall Street Journal, 1/25). Co-author Jerome Kassirer, former editor of the New England Journal of Medicine, said some medical schools might face difficulty implementing the guidelines because "[a] lot of our funds for education and for lunches now come from pharmaceutical companies" (USA Today, 1/25). Co-author Troyen Brennan, a professor of medicine at Harvard, said, "It's clear that voluntary disclosure is not working and even small gifts can influence behavior."

Industry Reaction
Pharmaceutical industry executives warned against going too far with the guidelines, noting that industry sales representatives provide information to doctors that assures medications are used correctly. Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, said a voluntary code limiting gifts to doctors that was adopted by the industry three years ago has been effective (Los Angeles Times, 1/25). "The current rules ... really ought to address the concerns that they've got," Scott Lassman, an assistant general counsel for PhRMA, said (Wall Street Journal, 1/25). Mark Leahey, executive director of the Medical Device Manufacturers Association, warned against rules that treat device manufacturers and pharmaceutical companies equally. "In the device industry, the technologies are advanced and the therapy being delivered has a tremendous amount to do with the physicians' technique," so vendors need to teach doctors how to use many devices, he said (Los Angeles Times, 1/25).

Additional Reaction
Duane Cady, chair of the American Medical Association, said, "[D]rug and medical device manufacturers can play a role in educating physicians about new products" (New York Times, 1/25). AMA noted that its ethics guidelines recommend a limit on gifts but added that it has been "examining and updating" the policy (Wall Street Journal, 1/25). Daniel Troy, former chief counsel of FDA, said, "I subscribe to the crazy view that more information is better. This very sweeping proposed ban would really choke off an important flow of information to physicians." However, Sharon Levine, associate executive director of Kaiser Permanente's Northern California Group Practice, said there is "solid evidence it isn't the size of the gift, it's the gifting itself that creates a sense of loyalty and indebtedness." She added, "The industry is spending $13 billion per year on direct-to-physician promotion. That wouldn't be happening if it weren't resulting in changing patterns of utilization. It doesn't necessarily mean patients are getting bad care, but it does mean their influence is out there." According to the Post, the Kaiser Permanente practice and the Yale University School of Medicine are "among the only institutions" in the U.S. to have enacted comprehensive bans similar to those recommended by the authors of the JAMA article (Washington Post, 1/25). JAMA editor Catherine DeAngelis said the authors' recommendations likely will spur controversy in the medical field. She said, "There's some recommendations in there that I think are excellent. Whether all or some of them will be enacted, ... I don't know" (Los Angeles Times, 1/25). Steven Shea, vice dean of the faculty of medicine at Columbia University Medical Center, said the JAMA article will "prompt changes in policy and guidelines at many academic health centers, including ours" (New York Times, 1/25).

An abstract of the article is available online.

Broadcast Coverage
APM's "Marketplace" on Tuesday reported on the study. The segment includes comments from Zeke Emmanuel, chair of the Department of Clinical Bioethics at NIH, and Rothman (Palmer, "Marketplace," APM, 1/24). The complete segment is available online in RealPlayer.

NPR's "All Things Considered" on Tuesday reported on the study. The segment includes comments from Brennan; John Calfee, resident scholar at the American Enterprise Institute; Cohen; and Sanders Williams, dean of Duke University School of Medicine (Prakash, "All Things Considered," NPR, 1/24). The complete segment is available online in RealPlayer.

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