Massachusetts Tries to Corral Pharma Firms, Devicemakers

New Massachusetts regulations that limit the inducements that drug and device companies can offer to physicians for prescribing or using their products are said to be among the toughest rules adopted by any state. Adopted unanimously by the Massachusetts Public Health Council, the regulations will require public disclosure of payments of over $50 to physicians for speaking and consulting. In addition, these activities will be prohibited:

•    Payments or gifts for entertainment and recreation
•    Payments for any reasons “except as compensation for bona fide services”
•    Financial support to health care practitioners in training
•    Complimentary items such as mugs, pens, and calendars
•    Providing meals, except for modest repasts at educational and training events

Drug, biotechnology and device companies, as well as the hotel and convention industry, fought to shape the final regulations. This apparently had less to do with the prohibited actions—most of which are already banned under the pharmaceutical industry’s own code—than with the disclosure requirements.

These include disclosure of payments to physicians for speaking at pharma-sponsored events and for “consulting,” which covers a multitude of sins. Drug companies will now have to reveal payments to physicians and hospitals for “seeding trials,” designed to promote certain drugs. But they won’t have to say how much they’re paying providers to conduct research.

A case in which a Massachusetts anesthesiologist was accused of faking results in 21 studies raises some interesting questions about the potential effectiveness of these new rules. The physician, Scott S. Reuben, allegedly authored studies that claimed favorable results from trials of Pfizer’s Vioxx and Merck’s Bextra, both of which were later withdrawn from the market because of side effects that were reported after the FDA approved them. He also reported good results in studies of other widely used drugs that are still on the market. Pfizer funded some of Reuben’s research and paid him to speak on behalf of its products.

Had the new disclosure requirements been in effect earlier, the public would have known how much Reuben was paid for his speeches, but not how much he received for his research. And obviously, they would have been unaware of how he conducted those studies. (Actually, it’s hard to believe that, given the amount of control that pharma companies exert over clinical research, none of these companies questioned any of Reuben’s conclusions if, in fact, they were bogus.)

Disclosure is important. But if the state really wants to reduce the influence of pharmaceutical companies on physicians, it should prohibit their sales reps from giving drug samples to physicians. These samples, which doctors use to please and sometimes to aid patients, are the biggest lever that drug detailers have to get in to see physicians. There are other ways to ensure that needy patients get the medications they need.

Second, the regulations do nothing to restrict the scope of pharma-sponsored events–both their own and those put on by third parties—at which some speakers present slanted views to physicians about the latest medications and drug studies. While pharma support may be critical to medical societies that mount educational conferences, physicians are not likely to hear objective information about drugs at the “symposia” and dinners that surround these events.