Drug Trial Reforms Needed Overseas, HHS OIG Audit Finds
Reforms in the testing of drugs overseas are needed in order to protect foreign patients who take experimental medications and Americans who buy drugs based on those experiments, an audit by the HHS Office of Inspector General has concluded, the Washington Post reports. The report, set for release today, found that the number of pharmaceutical researchers working overseas who voluntarily report their findings to the FDA has risen from 271 in 1990 to more than 4,400 in 1999, a 16-fold increase that "dwarf[s]" the agency's capacity for inspecting test sites. Ten years ago, the FDA reported inspecting more than 8% of all voluntarily reported overseas drug experiments, but that figure dropped to nearly 1% by 1999. "More worrisome," the audit found that the FDA does not know how many foreign drug trials are not reported. According to the audit, the FDA has "little idea" where research takes place overseas, what "level of ethics review" exists in other nations, how foreign researchers recruit patients or how many patients are taking experimental drugs. The audit notes that drug trials have "skyrocketed" in Eastern Europe and Latin America, as well as in Russia, "where ethics review boards often are inexperienced and unsure of their roles." The report said that its findings "represen[t] a significant warning signal" that the FDA cannot guarantee the "adequat[e]" protection of patients in foreign drug trials.
To alleviate the situation, the report recommends that the FDA assist in training overseas ethics boards and "collect more information about how they operate," that it "push" foreign researchers to sign pledges to follow FDA rules and that it "encourage" U.S. companies to monitor overseas tests "more closely." The report also recommends that the HHS Office for Human Research Protections "work to guarantee the protection of foreign research subjects" and "push" for a voluntary accreditation program for foreign ethics boards. The lack of regulation of overseas drug trials is a "serious problem, it's growing, there needs to be something done about it right away," George Grob, HHS deputy inspector general, said, adding, "FDA's control is inherently weak and it is a problem that is inherently dangerous" (Stephens/Flaherty, Washington Post, 10/2).