An expert with the US Food and Drug Administration has said he was pressured by his agency to withhold study results showing the potential dangers of the anti-inflammatory drug Vioxx.
David Graham, a drug safety official at the FDA, testified at a congressional hearing that the agency, which is charged with safeguarding the US food and medicine supply, still interferes with the findings of test results.
'Vioxx is a terrible tragedy and a profound regulatory failure,' said Graham. He told the Senate's Finance Committee that the FDA was currently incapable of protecting the US against another Vioxx.
In the largest drug recall in history, pharmaceutical giant Merck withdrew Vioxx from the market on September 30, after a company-sponsored trial found that patients who took the medication for more than 18 months doubled their risk of heart attack or stroke.
Graham testified however that there were signs of problems with the drug in company studies as early as November 2000, almost four years before the September 30 withdrawal. By the time Vioxx was finally pulled, millions of patients around the world were using the drug. Vioxx was approved by the FDA in 1999.
Dr Graham also listed five other medicines currently available which he said needed further scrutiny.
