Medical research used by doctors often directed by the company selling the drug
December 10, 2012
The accuracy and integrity of medical research regarding the safety and efficacy of prescription drugs is critical to our national health care system. The FDA’s decision to approve a drug, your doctor’s decision to prescribe a drug, and your decision to take a drug—all of the decisions ultimately turn on the results of such research. So, who is conducting this important research and what are their motives?
The New England Journal of Medicine (NEJM) is indisputably among the most-respected medical journals in the world. Dr. Marcia Angell of Harvard Medical School is a former editor-in-chief of the journal. Dr. Angell wrote in a review that:
It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.
Over the last year (August to August), NEJM published 73 articles on original studies of new drugs, according to a review by The Washington Post. Of those articles, 60 were funded by a pharmaceutical company, 50 were co-written by drug company employees, and 37 had a lead author, typically an academic, who had previously accepted outside compensation from the sponsoring drug company in the form of consultant pay, grants or speaker fees.
When a drug company is paying for the research of its own drug, there are clear opportunities for the company to distort the outcome. According to Dr. Angell:
Is there some way (drug) companies can rig clinical trials to make their drugs look better than they are? Unfortunately, the answer is yes. Trials can be rigged in a dozen ways, and it happens all the time.
Drug company executives seeking to promote their drugs can design research that makes their products look better, select like-minded academics to perform the work, and can run the statistics in ways that make their own drugs look better than they are. And, if troubling signs about a drug arise, they can steer clear of further exploration.
In fact, the Washington Post report pointed out that the odds of coming to a conclusion favorable to the industry are 3.6 times greater in research sponsored by the industry than in research sponsored by government and nonprofit groups, according to a published analysis by Justin Bekelman, a professor at the University of Pennsylvania, and colleagues.
Dr. Angell gives the following example:
In view of this control and the conflicts of interest that permeate the enterprise, it is not surprising that industry-sponsored trials published in medical journals consistently favor sponsors’ drugs—largely because negative results are not published, positive results are repeatedly published in slightly different forms, and a positive spin is put on even negative results. A review of seventy-four clinical trials of antidepressants, for example, found that thirty-seven of thirty-eight positive studies were published. But of the thirty-six negative studies, thirty-three were either not published or published in a form that conveyed a positive outcome.
Manipulating medical research can lead to very real danger for the public. One of the most widely reported research controversies arose over the arthritis drug Vioxx. NEMJ eventually reported that the results of a clinical trial of Vioxx was funded by Merck and was co-written by two company researchers. Five years later, journal editors reported discovering that the authors had omitted key incidences of heart troubles, creating “misleading” conclusions about the drug’s safety. Before the drug was pulled from the market, according to a review by an FDA investigator, it caused an extra 27,000 heart attacks and cardiac-related deaths.
The diabetes drug Avandia has now been linked with tens of thousands of heart attacks. A two-year investigation by the U.S. Senate Finance Committee revealed that the drug giant GlaxoSmithKline knew of cardiovascular dangers associated with its drug Avandia for years yet tried to stifle concerns noted by several doctors about the medication. In July 2012, the company pleaded guilty to federal charges that it failed to accurately report clinical data on Avandia. GlaxoSmithKline reached an agreement with the Department of Justice to pay a $3 billion settlement. Federal prosecutors said the company had paid doctors and manipulated medical research to promote the drug.
The agreement, which also includes charges over the company’s marketing of Paxil and Wellbutrin, is the largest health care fraud settlement in U.S. history.
Pharmaceutical Liability Lawsuits Filed by Heygood, Orr & Pearson
Given the billions of dollars the pharmaceutical industry profits from the sale of their drugs each year, it is no wonder so many companies hide negative research results.
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