Look for a nice bump in investigator initiated trials

From the New York Times: Senators Seek Public Listing of Payments to Doctors

Makers of drugs and medical devices would be required to report publicly nearly all payments and gifts to doctors under legislation introduced Thursday in the Senate…
Companies with at least $100 million in annual revenues would have to make quarterly disclosures of gifts or payments that exceed $25, and the reports would be posted on a Web site. Companies failing to make the disclosures — and many have not complied with the laws in Minnesota and Vermont — would be fined at least $10,000 per infraction.

Under the bill, the provision of free drug samples and financing for clinical trials would not have to be disclosed.

I’m going to reserve judgment (for now) on whether such public reporting makes sense and address the issue of what should be included. There are good arguments for excluding drug samples and clinical trial spending.  The samples, after all, are for patients; it’s not as though doctors are pocketing the value of the drugs. And clinical trial spending is for research, which is needed for new drugs and which in any case is not a very profitable business for physicians.

These kind of rules can have unintended consequences, however. Clinical trial payments are not as straightforward as they look. Some investigator initiated trials (as opposed to trials that are done for drug registration), for example, are funded by pharmaceutical companies more to build relationships with physicians than to generate real research value. It wouldn’t be hard to imagine consulting revenues being transformed into grants for such pet projects. Samples are fairly highly regulated already so there’s less room for abuse. However, it’s not impossible to imagine an increase in the distribution of lifestyle drugs as samples to be consumed by physicians, office staff and friends.

My advice to the Senate is to be careful not to make the current problem worse.

September 7, 2007

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