Navigating the Health Care System
Can We Trust the Evidence in Evidence-Based Medicine?
When we and our providers seek solutions to our health problems, we depend on medical research to explain which treatments work best, the likelihood that a particular treatment will help, and the risks involved. We expect this evidencebased medicine, as it is called, to identify the best possible care.
Sources that health professionals turn to include research published in respected medical journals, continuing education courses presented by experts, and clinical practice guidelines established by expert review committees that evaluate medical research to define standards of good care.
What few people realize is that medical research has undergone a quiet but radical transformation. Before 1970, the vast majority of clinical research was funded by government sources.4 By 2009, 85 percent of clinical trials were commercially funded.5 In 1991, 70 percent of clinical research was commercially funded, but about 80 percent of this research was still being done in universities, where academic checks and balances supported the independence of researchers. By 2004, however, only 26 percent of this research was conducted in academic medical centers. The rest was conducted by for-profit research companies, a trend that continues today.6
When drug and medical device companies fund research directly through private contracts, they are able to influence the study design and the published results. For starters, drug companies can select the characteristics of the people included in a study to highlight the benefits of the drug and minimize the risks—including studying the product on healthy, younger people who take few other medications and are therefore less likely to have adverse effects, even though the drug is more likely to be taken by older people taking multiple medications. The drug companies are not required to compare their products with other known treatments, and they can end studies if the results don’t appear favorable. Though they still must report results of most studies to the FDA , drug companies don’t have to publish studies that don’t come out the way they had hoped. And many of the authors of the research articles published in even the most respected medical journals have access only to data the drug companies choose to make available to them.
Because of these limitations, medical literature often gives an unbalanced picture of drug risks, benefits, and alternatives. Two studies published in 2003, one in the Journal of the American Medical Association (JAMA) and the other in the British Medical Journal, found that commercially funded studies were 3.6 to 4 times more likely than noncommercially funded studies to show positive results for the sponsor’s product.7 Another JAMA study that looked only at highest quality studies found even stronger bias: The odds that commercially funded research found the sponsor’s product the treatment of choice were 5.3 times greater than for studies funded by nonprofits.8 And yet another study found that when clinical studies are commercially funded and authors have financial ties to the sponsor (sometimes as paid speakers or consultants), the odds are 8.4 times higher that the results of the study will support use of the sponsor’s drug.9
Another problem with commercially funded studies is that the articles published are sometimes “ghostwritten” by companies hired by pharmaceutical companies. In 2010, thousands of court documents stemming from a civil lawsuit over the safety of hormone therapy (HT) were made public. Analysis of these documents revealed that Wyeth pharmaceutical company, maker of the popular hormone drugs Premarin and Prempro, paid ghostwriters to produce twenty-six scientific papers promoting the benefits and downplaying the risks of HT and then found academic physicians willing to put their names on them and submit them to peer-reviewed journals.10 In addition to downplaying the perceived risks of breast cancer and promoting cardiovascular benefits of hormone therapy, the articles promoted off-label, unproven uses, such as the prevention of dementia and Parkinson’s disease—both of which were later debunked by the Women’s Health Initiative study.
Unfortunately, the agencies we count on to protect the interests of health consumers are increasingly compromised. More than half of the funding for the Center for Drug Evaluation and Research, the division of the U.S. Food and Drug Administration that approves new drugs and oversees drug safety, comes from user fees paid by drug companies. Medical journals, trusted to evaluate articles independently, themselves depend on money from pharmaceutical advertising and from selling reprints of commercially favorable published articles to corporate sponsors, whose drug reps then distribute them to physicians. So‑called expert committees that produce the clinical practice guidelines that inform and direct health care professionals are often dominated by researchers with active financial ties to one or more companies that make the drugs under consideration. And about 70 percent of continuing medical education courses for doctors are paid for by drug companies and other medical industries. Since doctors must participate in continuing medical education to maintain their medical licenses, it becomes increasingly difficult to avoid exposure to industry-sponsored messages.
The fundamental reason that companies create and distribute this information is to fulfill their primary fiduciary responsibilities to their shareholders and investors. Increasing product sales increases corporate bottom lines. Our health is relegated, at best, to a secondary consideration.
We need to demand complete transparency so we’ll know when medical experts quoted by the media are receiving research funding or advising/consulting/speaking fees from drug and biomedical companies. We need to advocate for stricter standards in both the regulatory agencies and the medical journals that evaluate and publish research results. And we must insist that clinical guidelines that inform our doctors’ decisions be free of commercial interest.
The commercial takeover of our medical knowledge is, at its core, not a scientific problem but a political one. Reorienting our health care system to the service of public rather than private interests will occur only when an engaged and active citizenry creates a political force that stands at least equal to the political power of the drug industry.
Some change is already under way. Harvard Medical School instituted new rules in 2010 prohibiting professors from getting paid by drug companies to deliver educational talks and from accepting personal gifts, travel, or meals from drug companies. The new rules also restrict the amount of money professors can earn from consulting to drug companies or serving as board members. Some medical journal editors are requiring drug companies to register studies in advance, before rather than after the results are known, so that negative results are easier to track. And following the lead of Minnesota, more states are requiring drug companies to disclose payments to doctors. Some drug companies have begun posting doctors’ names and compensation online. ProPublica compiled these disclosures into one database—projects.propublica.org/docdollars—that allows patients to search for their doctor. As ProPublica notes, “Receiving payments isn’t necessarily wrong, but it does raise ethical issues.”
Excerpted from the 2011 edition of Our Bodies, Ourselves. © 2011, Boston Women's Health Book Collective.
4. Thomas E. Andreoli, “The Undermining of Academic Medicine,” Academe 85, no. 6 (November–December 1999): 32–37.
5. C. DeAngelis, “Conflicts of Interest—Facts and Friction,” 26th Fae Golden Kass Lecture, Harvard Medical School, October 30, 2008.
6. R. Steinbrook, “Gag Clauses in Clinical Trial Agreements,” New England Journal of Medicine 352 (2005): 2160–62.
7. Justin E. Bekelman, Yan Li, and Cary P. Gross, “Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review,” Journal of the American Medical Association 289 (January 2003): 454–65. See also Joel Lexchin, Lisa A Bero, Benjamin Djulbegovic, and Otavio Clark, “Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review,” British Medical Journal 326 (May 2003): 1167–70.
8. B. Als-Nielsen, W. Chen, C. Gluud, and L. L. Kjaergard, “Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events?” Journal of the American Medical Association 290 (2003): 921–28.
9. R. H. Perlis, C. S. Perlis, Y Wu, et al., “Industry Sponsorship and Financial Conflict of Interest in the Reporting of Clinical Trials in Psychiatry,” American Journal of Psychiatry 162 (2005): 1957–60.
10. A. J. Fugh-Berman, “The Haunting of Medical Journals: How Ghostwriting Sold ‘HRT,’ ” PLoS Med 7, no. 9 (2010), plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000335.
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