Volume 2  Number 1  January 20, 2005
Second Opinions

Big Pharma and the Ties That Bind: The Politics of Drug Promotion

The relationship between medical journals and the drug industry is "somewhere between symbiotic and parasitic," according to the editor of the Lancet, Richard Horton, who testified recently to the House of Commons select committee on health. Dr. Horton described some of the financial incentives that could influence a commercially run medical journal to publish a paper. For example, many of the research papers published in the Lancet are reprinted and bought in bulk by drug companies to use for marketing purposes. It does not require imagination to realize that companies regularly exert pressure on the journal to publish certain papers by arguing that doing so will earn the journal more money.

Dr. Horton gave another example of the parasitic relationship of Big Pharma to medical journals: he disclosed that when the Lancet raised questions with the authors of a paper on Cox-2 inhibitors, (Vioxx © one of these drugs has already been withdrawn, the other, Celebrex © may soon follow), the drug company sponsoring the research called Dr Horton, asking him to "stop being so critical," threatening to pull the paper "...and that means no income for the journal." That this is an international and not a British problem is well-known among medical journal editors who continue to struggle with conflict of interest questions involving their contributors.

An editorial in the Annals of Internal Medicine (141:1, 6 July, 2004) admits that conflicts of interest "are pervasive in biomedical research, that such conflicts cause harm, and "that conflicts can undermine the publicís trust in the medical profession." Yet, later the same editorial states "While we prefer to avoid commentary from authors with potential conflicts, we have to weigh the possible harm against the benefits of their expertise..." This statement is not surprising in view of the paucity of unbiased researchers who are not already on the payroll or receiving research grants from drug companies. Last June, editors of the New England Journal of Medicine (NEJM) made a startling announcement: They declared they were dropping their previous requirement that authors of medical review articles could not have financial ties to companies whose drugs they were reviewing. While this standard only applied to reviewers, the actual authors of scientific studies in medical journals are often bought and paid for by private drug companies with an obvious stake in the scientific (read "favorable") results. Moreover, while the NEJM and some other journals disclose these conflicts, others do not. In many cases data is often collected, discussed and analyzed by the drug maker. An independent 1996 study found that 98 percent of scientific papers based on research sponsored by corporations promoted the effectiveness of a company's drug. This corruption reaches from the doctors prescribing a drug to government review boards to university research centers.

The problem extends to financial ties with medical experts setting nationwide professional guidelines for treating conditions ranging from asthma to heart disease. Surveys reveal that nine out of ten experts writing such guidelines have financial ties to the pharmaceutical industry, yet those ties are almost never disclosed in consensus statements and other official or semi-official treatment guidelines, which are often published in medical journals and endorsed by medical societies. The Food and Drug Administration, routinely allows researchers with ties to the industry to sit on drug approval advisory committees. In many cases, half the panelists on such committees have a financial stake in the outcome.

On January 17th, The New York Times carried a lead article in their business section on a dispute between the BMJ, a leading medical journal, and Eli Lilly & Company, makers of Prozac. On New Yearís Day, the BMJ had published a news article suggesting that "missing" documents from a decade-old lawsuit indicated that Lilly had minimized data about the drugís risks of causing suicidal or violent behavior. While Lilly has not taken legal action, itís lawyers consider the article to be "inaccurate and defamatory." What we do know is that the articleís appearance follows the recent controversy over whether drug makers adequately disclosed the risks that antidepressants like Prozac, Paxil, and Zoloft (called "SSRI's") posed to pediatric patients, and whether the FDA ignored or played down potential risks of Prozac over 14 years ago when the agency panel decided not to issue any additional warnings. As a result of the recent controversy about the potential suicide risks posed by antidepressants to children and teenagers, the F.D.A. last week sent out final new labeling language about those dangers to all makers of such drugs, including Lilly. The British, on the other hand, actually banned the use of Paxil for kids last June, and went on to ban all the other SSRIís for the pediatric group.

Dr. Paul Rosch, President of The American Institute of Stress, discusses Big Pharma in his outstanding publication, Health and Stress. He documents multiple examples of "misleading drug promotion, overpricing, and the corruption of the medical and Governmental establishment by the pharmaceutical industry in a pattern of widespread abuse." Dr. Rosch also reports that a year ago 94% of the more than 5,000 scientists at NIH were engaged in lucrative conflict of interest activities, and that top officials had received over $2.5 million in fees and stock options from drug companies over the past decade. In 2002, the pharmaceutical industry spent $91.4 million on federal lobbying activities, and at least another $50 million was spent to "influence Congress and others through advertising, direct mail, telemarketing, and grants. Drug companies had 675 registered lobbyists and 26 of these were former members of Congress." This, according to other articles quoted by CNN and appearing in The New York Times, The New Yorker, Time, The Nation, and other publications, is only the tip of the iceberg.

The science fiction writer, Neal Stephenson, author of Snow Crash (1992), the three part trilogy The Baroque Cycle, and other philosophical-historical novels, offers an intriguing name to current medical economics. He describes how the political system has always been subject to "power disorders," sudden deviations or disequilibria in which "certain groups or persons suddenly concentrate a lot of power and abuse it." Does this phenomenon describe what is happening to medicine today? Or is it perhaps only one of many pathologies afflicting our present system of health care?

Stay tuned.

Martin F. Sturman, MD, FACP

Copyright 2005, Mathemedics, Inc.

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