http://www.boston.com/news/local/maine/articles/2004...

There is a recent trend for pharmaceutical companies to conduct abroad studies that could reasonably be done in the United States. The number of new foreign investigators in the FDA=s database grew from 988 in the 1990‑1992 period to 5,380 in the 1996‑1998 period.‏¹¹ Some of these studies have been marked by severe abuses. The Washington Post has reported that the apparent local IRB approval of a Pfizer-sponsored pediatric meningitis study in Kano, Nigeriawas based on an IRB document back-dated by one year.‏¹² In addition, Public Citizen exposed a study of Discovery Laboratories’ new surfactant in the treatment of neonatal respiratory distress syndrome that was to have been conducted in several Latin American countries.‏¹³ Some patients would have been randomized to placebo, even though the FDA had already approved four surfactants, which have been proved to reduce neonatal mortality by 34%. The ethics of the proposed trial were discussed at an internal FDA Scientific Rounds with the extraordinarily inappropriate, but revealing, title “Use of placebo-controls in life threatening diseases: is the developing world the answer?” A strong statement by the Committee condemning the export of pediatric studies for the purposes of exploiting the lack of ethical oversight or the poverty of pediatric patients in developing countries would be most helpful.

http://www.citizen.org/publications/release.cfm?ID=7...