Alosetron: a case study in regulatory capture, or a victory for patients' rights?

摘要

Advisers from the Food and Drug Administration (FDA) warn of more deaths if alosetron (Lotronex) returns to the market later this year. A former FDA insider says the United States regulatory agency has become a servant of the drug industry, citing his experience with alosetron. The FDA and GlaxoSmithKline reject allegations and say decisions on alosetron were motivated by concerns for patients. Reform that would end drug industry funding of FDA reviews is needed.