Academic journal article The Hastings Center Report

Patients, Patents, Profits

Academic journal article The Hastings Center Report

Patients, Patents, Profits

Article excerpt

In March, the Hastings Center and the Center for Religious Inquiry at St. Bartholomew's in mid-town Manhattan co-sponsored a seminar titled "Vioxx, Celebrex, and Aleve: Patients, Patents, Profits, and the Public Interest." The seminar explored the testing, marketing, and pricing of prescription drugs; the FDA's role in approving drugs for sale and monitoring drug safety; and the consequences of direct-to-consumer advertising of pharmaceuticals. It also examined the often-conflicted relationships between pharmaceutical companies, academic researchers, clinicians, and the FDA.

The seminar was held a few months after Merck withdrew its blockbuster drug Vioxx from the market because of evidence that it raised an individual's risk for serious cardiovascular events. That was a watershed event. Still, since the seminar, concerns about how drug companies promote drugs, what the FDA and others know about the drugs, and about whether the FDA adequately monitors and responds to drug safety issues have only increased.

While the federal government has not taken any action on these issues, interesting policy developments are in motion elsewhere. In June, Maine became the first state to pass a law requiring pharmaceutical companies doing business in the state to list their clinical trials on a publicly accessible Internet web site. The listing will include, among other things, information about the study drug's potential or actual adverse effects.

Two days before lawmakers passed the clinical trials registry bill in Maine, Bristol-Myers Squibb released a "Direct-To-Consumer Communications Code," becoming the first pharmaceutical company to adopt a voluntary policy on advertising prescription drugs to consumers. …

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