FDA Says Stands by Safety of Approved Drugs

[maddezmom]

NEW YORK (Reuters) - The U.S. Food and Drug Administration (news - web sites) said on Friday that Senate testimony by a veteran FDA (news - web sites) researcher regarding safety risks for five drugs does not reflect the views of the agency.



Dr. David Graham, speaking at a Senate hearing Thursday, singled out Abbott Laboratories Inc.'s weight-loss drug Meridia, AstraZeneca Plc's cholesterol fighter Crestor, Pfizer Inc.'s arthritis treatment Bextra, Roche's acne drug Accutane and GlaxoSmithKline's asthma drug Serevent.


"The five specific drugs that Dr. Graham identified in his oral testimony are currently approved as safe and effective for use in the United States," Dr. Steven Galson, acting director for the FDA's Center for Drug Evaluation and Research, said in a statement published on the FDA Web site.


"FDA takes all allegations of safety risks seriously and will continue its longstanding practice of assessing the safety of all drugs using only sound science and peer-reviewed analysis and literature," Galson added.



http://story.news.yahoo.com/news?tmpl=story&cid=578&ncid=578&e=3&u=/nm/20041119/ts_nm/health_fda_dc

I'll take Dr. Graham's advice over the FDA anyday.

[Avalux]

1. I watched this hearing last night on CSPAN

I'm in the business and it's pretty clear to me the pharmaceutical companies have the FDA in their back pocket. I worked on a Vioxx study and I know Merck had the adverse event info years ago - I saw it and reported it. The FDA approved that drug when they shouldn't have.

[spotbird]

2. After that investigation the FDA will present awards

to those companies which deserve accommodation for protecting the public interest.

[snippy]

3. The Vioxx debacle was partly the result of the "reform" of the FDA

passed by the republicans in 1997. That law expanded funding for the initial approval process by the FDA but restricted spending on ongoing safety studies of patients taking a medication for longer periods of time than what was used for the initial approval process. The reform of the FDA was one of Newt Gingrich's constant themes following the 1994 elections. First he advocated it and then he boasted of it.

[damntexdem]

4. And Chiron's flu vaccine is just fine, too.

There's nothing to see here, move along now and take your drugs.