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Healthy Skepticism Library item: 2672

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: news

Rovner J.
FDA Woes May Lead to Credibility Problems
NPR (National Public Radio ) 2005 Oct 12
http://www.npr.org/templates/story/story.php?storyId=4956167&ft=1&f=1001


Notes:

Vera Hassner Sharav’s Comments:
The FDA’s failure to ensure drugs are properly tested in trials designed to detect serious adverse effects, and the agency’s failure to require follow-up post-marketing studies to be reasonably secure in the knowledge that no lethal drugs are unleashed on the public has eroded public trust. Former FDA Commissioner, Dr. David Kessler (who served under both former President George Bush and Bill Clinton) and is now dean of the University of California at San Francisco, told National Public Radio (on All Things Considered, October 12) that the FDA’s credibility is at the lowest level he has ever seen. He said that FDA’s credibility is at its lowest level among physicians and the public. The failure to appoint an acting commissioner from within the professional ranks of the FDA leads Dr. Kessler to say, he’s “not sure the White House trusts the FDA.” Listen to audio: http://www.npr.org/templates/story/story.php?storyId=4956167&ft=1&f=1001


Full text:

Health Care
FDA Woes May Lead to Credibility Problems

Listen to this story here http://www.npr.org/templates/story/story.php?storyId=4956167&ft=1&f=1001 by Julie Rovner

All Things Considered, October 12, 2005 · The sudden resignation of Food and Drug Administration Commissioner Lester Crawford in September again highlights problems at the agency. The FDA regulates products that account for one of every four dollars spent in the United States. But some say recent missteps could be costing FDA the credibility it needs to assure the safety of all Americans.

 

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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.