This is a follow-up to Tuesday’s Infomail about the recommendations of a group of prominent physicians who recommend a self-imposed ban on financial ties between academia and drug manufacturers. The recommendations, published in the Journal of the American Medical Association (JAMA): JAMA. 2006;295:429-433, are an outgrowth of a recognition that medicine–in research and practice has been overrun by industry and the consequences are alarming:
"Conflicts of interest between physicians’ commitment to patient care and the desire of pharmaceutical companies and their representatives to sell their products pose challenges to the principles of medical professionalism. These conflicts occur when physicians have motives or are in situations for which reasonable observers could conclude that the moral requirements of the physician’s roles are or will be compromised. Although physician groups, the manufacturers, and the federal government have instituted self-regulation of marketing, research in the psychology and social science of gift receipt and giving indicates that current controls will not satisfactorily protect the interests of patients. More stringent regulation is necessary, including the elimination or modification of common practices related to small gifts, pharmaceutical samples, continuing medical education, funds for physician travel, speakers bureaus, ghostwriting, and consulting and research contracts. We propose a policy under which academic medical centers would take the lead in eliminating the conflicts of interest that still characterize the relationship between physicians and the health care industry. "
The New York Times reports: "Broadly adopted, the recommendations would transform doctors’ day-to-day lives and shut off the focus of drug makers’ biggest expenditures."
However, it appears the authors of the paper do not agree about its impact:
Dr. David Blumenthal is quoted saying it was "not very likely" that many in medicine would listen to the group."
But Dr. Steven Shea, vice dean of the faculty of medicine at Columbia University Medical Center, predicted that the journal article would "prompt changes in policy and guidelines at many academic health centers, including ours."
JAMA editor, Dr. Catherine DeAngelis, pays obligatory lip service by acknowledging: "there has been a substantial change in the way pharmaceutical companies function over the last decade," pharmaceutical companies are "far more aggressive in their marketing efforts." She acknowledges "these efforts are having a deleterious effect on the practice of medicine."
However, the evidence shows that journals–such as JAMA and The New England Journal of Medicine–are complicit in that "aggressive marketing" by flooding its pages with drug advertisements. Journal editors’ public pronouncments notwthstanding, financial interests trump ethical / scientific standards thereby undermining the integrity of medicine.
Although the Ethical Guidelines adopted by the International Committee of Medical Journal Editors (ICMJE, 2004), include advertising practices in peer-reviewed journals, a newly released, quantitative data analysis found that advertising ratios in JAMA and The NEJM (ratio of advertisements to editorial content) were excessive and disproportionate compared to low-circulation specialty science journals.
Indeed, the authors found that JAMA and the NEJM are saturated with display advertisements–just like high-circulation consumer magazines. Furthermore, 50% of the ads are placed by the Big 5 Pharma corporations.
The authors cite an earlier study that reveiwed the accuracy of advertisements in peer-reviewed journals and found that: "32% of the advertisements misled readers regarding efficacy, 40% did not provide balanced descriptions of the side effects, and 44% could lead to improper prescribing if the physician did not use other sources of information regarding the drug."
So, there is clear-cut evidence that the major, most read, and most influential medical journals are themselves the purveyors of false claims about treatments that lead physicians to improper prescribing practices.
See: Friedman, LS and Richter, ED, Excessive and Disproportionate Advertising in Peer-reviewed Journals, International Journal of Occupational Environmental Health, 2006:12:59-64. The authors note, "The findings suggest a dissonance between the ethical guidelines and the de facto advertising practices of arguably the two most important member journals of the ICMJE. There is a need to define and apply standards for excessive and disproportionate advertising."
This is but another demonstration of misplaced trust in the gatekeepers of (what are supposed to be) the most authoritative sources of medical information.
Academic medicine is shown again and again to be disinclined to abide by its own declared ethical standards–as long as these standards are self-imposed and voluntary.
When it comes to financial interests, human nature is what it is. Neither highest credentials, or professional standing are a safeguard against bending the rules of conduct, or selling out to the highest bidder. Misplaced trust in the medical establishment has resulted in tainting medical institutions, clinicians, researchers, and our medical knowledge base. The medical profession must be held to standards and enforcement mechanisms as is any other trade or profession.
Contact: Vera Hassner Sharav
In Article, Doctors Back Ban on Gifts From Drug Makers
By GARDINER HARRIS <http://query.nytimes.com/search/query?ppds=bylL&v1=GARDINER%20HARRIS&fdq=19960101&td=sysdate&sort=newest&ac=GARDINER%20HARRIS&inline=nyt-per>
The gifts, drugs and classes that makers of pharmaceuticals and medical devices routinely give doctors undermine medical care, hurt patients and should be banned, a group of influential doctors say in today’s issue of The Journal of the American Medical Association.
Medical schools and teaching hospitals should be the first to establish a comprehensive ban, the group writes. But the authors argue that all doctors should eventually follow suit.
Broadly adopted, the recommendations would transform doctors’ day-to-day lives and shut off the focus of drug makers’ biggest expenditures. But Dr. David Blumenthal, an author of the article, said it was "not very likely" that many in medicine would listen to the group.
"I’m not very optimistic," said Dr. Blumenthal, a professor at Harvard Medical School who, like many of the article’s 10 other authors, has studied conflicts of interest in medicine for years.
Federal law forbids companies from paying doctors to prescribe drugs or devices, but gifts and consulting arrangements are almost entirely unregulated. Voluntary professional guidelines suggest that doctors refuse gifts of greater than "modest" value. Sanctions against doctors who accept gifts of great value are extremely rare.
The drug industry spends tens of billions of dollars a year to woo doctors, far more than it spends on research or consumer advertising. Some doctors receive a significant part of their income from consulting arrangements with drug and device makers. Others take regular vacations and golfing trips that are paid for by companies.
A recent lawsuit involving the device maker Medtronic revealed that one prominent Wisconsin surgeon received $400,000 for a consulting contract that required him to work just eight days. While such rich arrangements are often restricted to specialists, most physicians routinely accept small gifts from drug salespeople, including pens, mugs, pads and food.
Surveys show that most doctors do not believe that these gifts influence their medical decisions, although most believe that they do affect their colleagues’ medical judgment.
But even small gifts can lead to profound changes in doctors’ prescribing behavior, with "negative results on clinical care," the article states. As a result, all gifts should be banned, the authors conclude.
Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America, said the drug industry had a voluntary code of marketing conduct.
"Only practices that do not compromise independent judgments of health providers – such as modest working meals, gifts of minimal value that support the medical practice, and distribution of free samples – are permitted," Mr. Johnson said in a statement.
Dr. Duane M. Cady, board chairman of the American Medical Association, said in a statement that "drug and medical device makers can play a role in educating physicians about new products." He said the organization was "in the process of examining and updating its policy on gifts to physicians from industry."
The article is part of a spate of reports in medical journals that have taken a skeptical view of drug makers’ influence on medical practice and research. The New England Journal of Medicine recently published an article accusing Merck of withholding crucial safety information about the withdrawn painkiller Vioxx, a charge that Merck denies. Other articles have criticized drug makers’ tendency to keep the results of human research secret.
Dr. Catherine DeAngelis, editor in chief of The Journal of the American Medical Association, said drug makers were a vital part of the nation’s health care system because of their research efforts.
"But there has been a substantial change in the way pharmaceutical companies function over the last decade," Dr. DeAngelis said. Drug makers are far more aggressive in their marketing efforts, she said, and these efforts are having a deleterious effect on the practice of medicine.
Dr. Steven Shea, vice dean of the faculty of medicine at Columbia University Medical Center, predicted that the journal article would "prompt changes in policy and guidelines at many academic health centers, including ours."
Kaiser Permanente, the California-based managed-care group, is one of the few medical organizations in the United States that have enacted nearly all of the recommendations suggested by the journal article. Kaiser physicians prescribe heavily marketed medicines far less frequently than doctors nationally.
"We thought it was critical for us that our patients never had a doubt that the decision made about a drug or a device was based on the best interests of the patient and not the financial interest of the physician," said Dr. Sharon Levine, associate executive director of Kaiser Permanente Northern California.
The article also argues that "no strings attached" consulting arrangements should be banned, and that all other consulting agreements should be posted on Web sites. Doctors should refuse free drug samples, the article states, because they are "a powerful inducement for physicians and patients to rely on medications that are expensive but not more effective."
Such a refusal would also eliminate one of the principal reasons for which drug salespeople are routinely allowed to enter doctors’ offices, the article states. While the article does not suggest that salespeople be refused entry into offices, it states that such visits have few useful functions.
"Would we be delighted if drug reps never saw the inside of doctors’ offices? Absolutely," said Dr. David J. Rothman, president of the Institute of Medicine and one of the article’s two principal authors. "But you can’t mandate that. It’s a free country."
Two years ago, Dr. Rothman received a $7.5 million grant from the financier George Soros <http://topics.nytimes.com/top/reference/timestopics/people/s/george_soros/index.html?inline=nyt-per> to set up an organization that would study medical professionalism. Today’s article is in part an outgrowth of that grant, he said.
Dr. Troy A. Brennan, former chairman of the American Board of Internal Medicine and the other principal author of the article, said he was looking forward to reading responses to it.
"I don’t think there are a lot of good answers as to why it’s O.K. to accept these gifts and contracts," Dr. Brennan said.
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