'Many Clinical Trials Moving Overseas"

Source: Amanda Gardner, Health Day, U.S. News and World Report, February 18, 2009

A report that appears in the Feb. 19 issue of the New England Journal of Medicine reviewed 300 published reports in major medical journals.

A third (157 of 509) of Phase 3 trials -- typically the largest and most significant trial in the development of a drug -- led by major U.S. pharmaceutical companies were being conducted entirely outside the United States. In addition, half of the study sites (13,521 of 24,206) used in these trials were located overseas, with many in Eastern Europe and Asia.

At the same time, the researchers found, the number of FDA-regulated investigators running trials abroad has increased by 15 percent each year, while the number of U.S.-based investigators declined 5.5 percent annually.

Comment: The article goes on to point out that drugs proved effective in other populations may not be effective in U.S. populations, that sometimes the protection of human subjects is not what it should be in Asia and Eastern Europe, and that testing drugs in populations that will not be able to afford them if they prove safe and effective is itself unethical.

I had not realized that the shift was occurring so rapidly.

The current economic crisis is likely to devalue the dollar and make the U.S. more competitive for drug research as well as other economic activities. The development of a national health record system may also help make this country more attractive for drug testing.

On the other hand, we really need to contain health care costs in the United States and the strategy and tactics we need to use to do so may reduce the problem by reducing the incentives to develop new (me too) drugs for the U.S. market. JAD