HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Tuesday, April 25, 2006

Trusting the Pharmaceutical Companies

Kevin Drum of the Washington Monthly points to a great article in the LA Times by Shannon Brownlee discussing the manner in which the United States permits drug companies to fund the clnical trials into a drug's safety and effectiveness.  She is not impressed with their research.

Researchers scoff at the notion that that their scientific integrity is for sale. Certainly most researchers aren't corrupt, but their institutions are guilty of allowing the drug industry to manipulate medical science.

Meanwhile, industry-funded research is failing to provide the clinically useful answers physicians and patients need in order to pick the best treatment. Which drug is right for which patient? What are the risks? Are the added benefits of a new, expensive drug worth the cost? If not, should insurance companies and Medicare be paying for them?

If we want answers to such questions, the public is going to have to start paying for them. Earlier this year, a $44-million National Institutes of Health study found that drug makers' claims notwithstanding, not one of the five newer antipsychotic drugs offered any meaningful improvement over an older drug that cost up to 10 times less.

But the study looked at only one category of drug. If we want high-quality medical care, dozens of other drugs — as well as medical devices and non-drug treatments — should be subjected to the same noncommercial scrutiny.

Because the FDA has been flunking, the NIH might seem like the most obvious agency to fund such studies, but it isn't set up to do the job. The institutes spend only a tiny fraction of their $30-billion annual budget on clinical research, and they have historically focused on basic science, not on studying the safety and effectiveness of drugs.

What's needed is a new Institute for Effective Medicine, which would need to be modeled on the Federal Reserve Board or the Securities and Exchange Commission to protect it from political pressure. Its mission would be threefold. It would serve as a new, independent source of research dollars for medicine. It would provide independent evaluation of data generated by industry. And it would oversee the creation of clinical practice guidelines, a manual of proven "best practices" for physicians devised entirely without industry influence.

Interesting solution to what seems to be a problem with our current drug approval process.  [bm]

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