PUSH FOR MORE TRIALS MAY HURT PATIENTS
July 26, 2010
U.S. pharmaceutical companies are increasingly going abroad to conduct clinical trials required by the Food and Drug Administration (FDA). Recently, the Department of Health and Human Services (HHS) released a report suggesting that the FDA lacks the resources to adequately monitor these foreign trials. Four of every five new drugs sold in the United States are tested in foreign trials, and the FDA inspects less than one in 10 of these. This is half the rate of inspection for domestic trials, say Anup Malani, a professor at the University of Chicago Law School, and Tomas J. Philipson, the Daniel Levin professor of public policy at the University of Chicago.
Several of the HHS report's recommendations should be embraced -- particularly those that will improve transparency for foreign trials, say Malani and Philipson. For instance:
- The FDA already requires that foreign trials operate under the Declaration of Helsinki, which mandates that patients be honestly informed about the risks and benefits of an experimental therapy and that enrollment be truly voluntary.
- But the agency has limited ability to screen foreign trials.
- As HHS suggests, the FDA should negotiate cooperative investigation agreements with foreign regulatory agencies and create a better electronic registry for foreign trials.
We should keep some perspective on the trend toward foreign clinical trials, say Malani and Philipson:
- While the United States represents just 5 percent of the world's population, it provides over 20 percent of patients for clinical research.
- The reason for the disparity is that the United States is responsible for almost one half of global research and development funding for new medicines.
Since the benefits of drug development are shared by the whole world, a proper balance of burdens would inevitably entail more, not fewer, clinical trials conducted outside our borders, say Malani and Philipson.
Source: Anup Malani and Tomas J. Philipson, "Push for more trials may hurt patients," Washington Examiner, July 21, 2010.
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