Healthy Skepticism Library item: 1979
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Moynihan R.
Alosetron: a case study in regulatory capture, or a victory for patients' rights?
BMJ 2002 Sep 14; 325:(7364):592-5
http://bmj.bmjjournals.com/cgi/content/full/325/7364/592
Abstract:
Summary points: 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.
Keywords:
*analysis
United States
Carbolines/adverse effects*
Carbolines/supply & distribution
Colonic Diseases, Functional/drug therapy*
Drug Approval
Gastrointestinal Agents/adverse effects*
Gastrointestinal Agents/supply & distribution
Humans
Patient Rights
Risk Factors
United States
United States Food and Drug Administration
