FDA defends its credibility by admitting that all prescription drugs are dangerous

At a Senate hearing, Dr. David Graham presented evidence regarding the withdrawal of Vioxx and mentioned five other drugs that needed study. The FDA responded that these five drugs are safe. Dr. Graham reported pressure from supervisors to water down his findings on Vioxx.

Dr. Sidney Wolfe, health research director for Public Citizen, a consumer watchdog group, agreed that the FDA supervisors don't want people to talk. The FDA trials are also criticized for being too short, lasting only 12 months. Problems were discovered after 18 months in the Merck trials. The FDA has also not responded to data which show that antidepressants are dangerous to children and teenagers.

• The food and drug administration, the pharmaceuticals regulator in the United States, was yesterday fighting to head off a crisis in confidence among the American public.
• In a strongly worded statement the FDA said it disagreed with the views of Dr David Graham, a senior safety official, who warned on Thursday that the US is "virtually defenceless" against another drugs scandal.
• He was presenting evidence at a Senate hearing about the withdrawal of the arthritis treatment Vioxx in September, which was found to cause an increase in heart attacks and strokes.
• Dr Graham identified another five drugs on the market which need further study.
• In an attempt to limit damage, Dr Steven Galson, acting director of the FDA's centre for drug evaluation and research said "we categorically reject" the accusation that the agency had failed to do its job.
• In an early morning television interview on NBC Dr Galson said: "All the drugs that are on the market have risks.
• What we're concerned about is hysterical charges that aren't based on reality."
• Referring to allegations from one senator on Thursday, Dr Galson added: "I think the drug industry would be astounded at the charges we're too cosy with them.
• I spend a lot of time dealing with complaints from the industry."
• On its website, the FDA said: "The five drugs that Dr Graham identified in his oral testimony are approved as safe and effective for use in the US."
• The allegations are the latest blows to the agency's reputation in recent months.
• Notably there has been concern about the FDA's slow reaction to the problems at the Liverpool plant which makes flu vaccine for Chiron.
• New York attorney general Eliot Spitzer filed charges against GlaxoSmithKline accusing the company of suppressing data from trials that showed an increased incidence of suicidal behaviour among children taking its drug Paxil.