Apr 192011
 

The Truth About the Drug Companies, written by a former editor-in-chief of The New England Journal of Medicine, focuses on the U.S. clinical trial apparatus and how it shapes the pharmaceutical drug industry worldwide. Author Marcia Angell tells readers why prices are higher in the U.S. than elsewhere in the world, why the majority of truly novel drugs are based on publicly funded research, not private-company R&D, and why much clinical trial research is biased by design. She also traces the history of how this happened. Copious citations and statistics lend support to her arguments, but equally supporting is the fact that here is a member of the medical establishment telling us how the public-private academic-government-pharma collaboration fails the citizens of the world.

For starters, Dr. Angell explains how the system works. In essence, “big pharma” companies:

  • Buy promising drug candidates from publicly funded sources, such as the National Institutes of Health (NIH) or university researchers;
  • Sponsor clinical trials that may feature biased study designs or outright suppression of negative results; and
  • Market incessantly to consumers and doctors, not only via straightforward sales pitches but also under the guise of “medical education.” This means sponsoring doctors’ continuing education and professional society meetings, offering doctors “honoraria as consultants and speakers,” even sponsoring patient advocacy groups.

The players in this drama are many and include:

  • “Big pharma” companies
  • The National Institutes of Health (NIH)
  • University research centers
  • Contract research organizations (CROs)
  • Medical Education Consulting Companies (MECCs)
  • Medical membership associations
  • Physicians
  • The U.S. Congress
  • Lobbyists
  • The U.S. FDA
  • The U.S. FTC
  • The U.S. Supreme Court
  • U.S. state governments

Overall, the book is an indictment of the system but also a plea for reform. It motivated me to refine the study ranking methodology used on this site. A future “to-do” will be to figure out a way to add an independence component to the ranking. I believe that independent studies of a remedy or compound should be given more weight than studies of that remedy funded by the company that makes it or the industry that supports it. Unfortunately, this information is not broadly and freely available in PubMed or any of the other medical-study databases. It should be.

In terms of something that can be done right away, I will refine the ranking methodology to prefer testing a new drug candidate (or lifestyle change) against the older standard of care (or usual recommendation), rather than against a placebo or an ineffective dose of an older drug. The goal of studies designed in this way is to show that the new drug (or lifestyle change) is an improvement, rather than simply better than nothing (and possibly worse than the old treatment!). The best study design to resolve doubt, according to Dr. Angell, may actually be one that compares a test item to the older standard of care as well as to a placebo control.

I strongly recommend The Truth About the Drug Companies for an insider’s look at what’s wrong with the current system. Despite the problems she identifies with big-pharma influence, Dr. Angell unsurprisingly retains a generally supportive view of allopathic medicine. At one point in the book, she states, “I would not have spent my professional life at The New England Journal of Medicine if I did not deeply believe in the value of medical research and innovative treatments.” In that, her viewpoint represents a rare thing that should not be overlooked: a conventional voice daring to speak up against conventional wisdom.

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