Testing Tidal Wave Hits Overseas

Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

Testing Tidal Wave Hits Overseas

Washington Post (www.washingtonpost.com) (12/18/00) P. A1
Flaherty, Mary Pat; Nelson, Deborah; Stephens, Joe

As the pharmaceutical industry and individual drugs companies become more international, groups are discovering that moving their testing programs overseas to less restrictive nations is a better option than performing trials in the United States, where regulators prevent studies of dangerous and questionable medicines and insist that patients are given high-quality care throughout the testing process--even those patients not taking the drug being reviewed. For instance, Glaxo Wellcome's irritable bowel syndrome medicine, Lotronex, has been withdrawn in the United States for concerns about its side effects in some patients, yet the company had 7,500 patients in tests of the drug throughout the world and will not finish phasing out the studies until the end of December, given their size and scope. Similarly, Triangle Pharmaceuticals was prevented by the Food and Drug Administration from performing large-scale trials in the United States after its prospective AIDS drug mozenavir was linked to heart arrhythmia in dog tests that could lead to blackouts and death, but the company won permission in Mexico for larger trials in humans with the promise from Triangle to the Mexican government that all health and especially heart information would be closely monitored. The lure of foreign testing sites is not just one of less stringent regulations--other benefits include a broader base of patients willing to undergo experimental treatments and lower cost; one Bristol-Myers Squibb executive noted that a trial that costs $10,000 per person in western Europe costs about $3,000 in Russia, and Eli Lilly reports that its foreign tests are booming, from 590 test patients for the company in all of Africa, the Middle East, and Central and Eastern Europe in 1994 to more than 7,000 this year and as many as 10,000 in Latin America over the coming five years.
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