Midlife and Menopause
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 tell us which treatments work best, how likely it is that a particular treatment will help us, and what kind of risks the treatment entails. We expect this “evidence-based medicine” to bring us the best possible care.
Health professionals’ trusted sources of scientific evidence include research published in respected medical journals, continuing education courses presented by experts, and clinical practice guidelines. Clinical practice guidelines are established by “expert review committees” charged with reviewing the best of medical research to define standards of good care.
What few of us know is that medical research has undergone a quiet but radical transformation over the past two or three decades.
Before 1970, the vast majority of clinical research was funded from government sources.1 This has changed dramatically. Three out of four of the clinical trials published in the top medical journals (The Lancet, the New England Journal of Medicine, and the Journal of the American Medical Association) are now funded by pharmaceutical companies.2 In 1991, about 80 percent of drug company-sponsored research was still being done in universities, where academic checks and balances supported the independence of researchers. But by 2000, only 34 percent of this research was still being done in academic medical centers. The rest had been transferred to for-profit research companies.
When drug companies fund research directly through private contracts, they are able to influence the results in many ways. Drug companies are not required to compare their products to other known treatments. They can select the age and gender of the people included in a study to highlight the benefits of the drug and minimize the risks. (For example, they can choose to study their product on healthy younger people who take few other medications and are thereby less likely to have side effects, despite the fact that the drug is more likely to be taken by older people taking multiple medications.) The drug companies can end studies if the results don’t appear favorable and choose not to publish studies that don’t come out they way they had hoped. And many of the authors of the research articles published in even the most respected medical journals don’t have access to all of the data from their own studies—only the data the drug companies choose to let them see. By controlling the design of the research, the criteria by which patients are selected, the analysis of the data, and which results are actually published, drug companies shape medical knowledge.
Research funded by the pharmaceutical and biotech industries is far more likely to produce results that support the sponsors’ interests. Two studies published in 2003, one in the Journal of the American Medical Association (JAMA) and the other in the British Medical Journal showed 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.3 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.4
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.5 The medical journals we trust to independently evaluate the articles they publish are also being influenced by the biomedical industries, as they depend on money from pharmaceutical advertising and from selling reprints of published articles to corporate sponsors, who then distribute them to physicians. The committees that produce clinical practice guidelines, which inform and direct health care professionals, are now dominated by experts with active financial ties to one or more companies that make the drugs under consideration.6 And about 70 percent of continuing medical education courses for doctors are now paid for by the drug and other medical industries. Since doctors must participate in continuing medical education to maintain their medical licenses, it becomes increasingly difficult for any of them to avoid being exposed to industry-sponsored messages.
As commercial interests gain an increasing role in determining our “medical knowledge,” it is important to understand that the fundamental reason that companies help create and distribute this information is to promote their products and improve their corporate bottom lines. Our health is relegated to, at best, a secondary consideration. We need to question whether doctors should be given financial incentives to follow clinical practice guidelines, as some now are, when those guidelines may be based on incomplete or biased research. Already we have evidence that “pay for performance” incentives can lead to inappropriate care for older people with multiple chronic diseases.7
We need to demand that the public know when medical experts receive research funding or advising fees from drug and biomedical companies. And we need to advocate for stricter standards in the regulatory agencies that evaluate research results and oversee clinical guidelines. As individuals we can ask our health care providers if they practice under “pay for performance” programs and then consider this fact when making decisions about their recommendations for diagnostic tests and prescription medications.
The commercial take-over of our medical knowledge is, at its core, not a scientific problem but a political one. The solution will require an engaged and active citizenry. For more information, see Overdosed America: The Broken Promise of American Medicine.8
End of excerpt.
Excerpted from Chapter 2: Making Health Care Decisions in Our Bodies, Ourselves: Menopause © 2006 Boston Women's Health Book Collective.
For more information on how the pharmaceutical industry influences medical knowledge, see Drug Companies & Doctors: A Story of Corruption and The Truth About the Drug Companies, two articles by Marcia Angell, a physician and former editor of The New England Journal of Medicine.
Endnotes:
1. Thomas E.Andreoli, “The Undermining of Academic Medicine,” Academe 85, no. 6 (November-December 1999): 32-37. [back to text]
2. The House of Commons Health Committee, The Influence of the Pharmaceutical Industry, Volume 1. April 5, 2005, p. 55. Accessed here on September 25, 2005. [back to text]
3. Justin E. Bekelman; Yan Li; Cary P. Gross, “Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review,” The Journal of the American Medical Association 289 (January 2003): 454-465. See also: Joel Lexchin, Lisa A Bero, Benjamin Djulbegovic, and Otavio Clark, “Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review” BMJ (British Medical Journal) 326 (May 2003): 1167-1170. [back to text]
4. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. “Association of Funding and Conclusions in Randomized Drug Trials: a Reflection of Treatment Effect or Adverse Events?" JAMA 290 (2003): 921–8. [back to text]
5. “Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities.” United States General Accounting Office, September, 2002, p. 9. Accessed at http://www.gao.gov/new.items/d02958.pdf on September 25, 2005. [back to text]
6. Rosie Taylor and Jim Giles. “Cash Interests Taint Drug Advice,” Nature 437, 20 (October 2005): 1070-1071. See also: Patrick J. O’Connor. “Adding Value to Evidence-Based Clinical Guidelines.” JAMA 294 (2005): 741-3. [back to text]
7. Cynthia M. Boyd, Jonathan Darer, Chad Boult, Linda P. Fried, Lisa Boult, Albert W. Wu. “Clinical Practice Guidelines and Quality of Care for Older Patients with Multiple Comorbid Diseases: Implications for Pay for Performance.” JAMA. 294 (2005): 716-724. [back to text]
8. This sidebar is based on the work of John Abramson, including the book Overdosed America: The Broken Promise of American Medicine and the article, “The Effect Of Conflict Of Interest On Biomedical Research And Clinical Practice Guidelines: Can We Trust The Evidence In Evidence-Based Medicine?” The Journal Of The American Board Of Family Practice 18 (2005): 414-418. [back to text]
Excerpted from Our Bodies, Ourselves: Menopause, © 2006, Boston Women's Health Book Collective.
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