Field Notes

Patients, Patents, Profits.

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. For a minimum of twelve months following the launch of a new drug, the company will not use television, radio, or print advertising to promote the new medication to consumers. In late July, the board of directors of the Pharmaceutical Research and Manufacturers Association gave preliminary approval to a set of "Guiding Principles" for direct-to-consumer advertising. It is doubtful that the final Principles will include an advertising ban like the one adopted by Bristol-Myers Squibb. The American Medical Association recently declined to support such a ban, opting instead to conduct a study on the effect of direct-to-consumer advertising on patient care.

Finally, an Institute of Medicine advisory committee heard testimony in June about problems with the current drug safety monitoring system. Created at the request of the FDA, the advisory committee will hold additional hearings and make recommendations regarding organizational, legislative, and regulatory reforms to improve risk assessment and safety monitoring of FDA-approved drugs. Whether these and other developments will reform the nation's drug safety monitoring system in a way that enhances patient safety remains to be seen.

The March seminar now appears to be the incentive for a longer period of research on patient safety, drug testing in clinical trials, and drug patenting and pricing. As the policy landscape evolves, the challenge is both to follow the policy developments and to keep them on track.