As the pendulum begins its inevitable return trip with the installation of a new administration in
One of the last-gasp, final-weeks efforts of the Bush administration would encode FDA guidelines allowing drug companies to market to doctors about non-approved, or off-label, uses of approved products. Some expect the new administration to overturn the recommendation. I say let it go. There was once a concept of the "marketplace of ideas," and I'm all for that. Say anything you want, marketers. My physician is smart enough to see what's real and what's spin. But first we need to be sure that my physician is getting the information he needs to make that judgment, starting with who's working for whom. That's where the focus of the new regulations should be because, frankly, that's one place where the FDA is falling flat on its face.
There have been more than enough studies to show that commercial support of clinical trials influences publication of outcomes. There is also little point in longing for the days when clinical research was free of commercial influence. I do buy the argument that commercial sponsorship can have an appropriate place in clinical research and in continuing education. But the embarrassing performance of the FDA in tracking and reporting commercial support and financial interests of clinical trial investigators is clearly spelled out in a January report by the Office of the Inspector General, available at http://oig.hhs. gov/.
This is pretty simple. What I as a patient believe about how strongly money influences my doctor's prescribing habits is both my responsibility and no one else's business. What my physician does to supplement his practice income through clinical trials, conference lectures or publication is subject to his or her code of ethics. But until we start truly disclosing who is paying for what, we're all wandering around in the dark.