David Graham

Washington, Feb. 17 (Reuters): A veteran US Food and Drug Administration scientist today said he saw no need for the pain drugs known as COX-2 inhibitors, which include the withdrawn arthritis drug Vioxx, as well as Celebrex and Bextra, citing increased heart risks.

The presentation by David Graham, associate director for science and medicine at the FDA?s Office of Drug Safety, came on the second day of an unusual three-day meeting called by the FDA after Merck & Co. pulled Vioxx from the market in late September. The recall was prompted by a study showing the drug doubled the risk of heart attack and stroke.

The FDA, which has come under fire in recent months as being slow to respond to serious drug side effects of drugs, is asking an advisory panel if COX-2 inhibitors offer enough benefits to stay on the market, if they need stronger warnings, and if further research is needed.

Graham said he saw a ?class effect? of heart risk from the COX-2 inhibitors, and it appeared greater with higher doses. But he told the panel of FDA advisers that each drug should be evaluated individually.

?The bottom line conclusion I came to is there really doesn?t appear to be a need for COX-2 (inhibitors)... I believe there is a (heart) effect and it?s dose related,? Graham told an FDA advisory panel.

COX-2 inhibitors, such as Pfizer Inc?s Celebrex and Bextra and Merck?s Vioxx, were designed to ease pain as effectively as older, non-prescription drugs known as non-steroidal anti-inflammatory drugs, while being easier on the stomach.

Graham, who is regarded as a maverick for his forthright criticism of the FDA?s ability to monitor the safety of drugs once they are on the market, presented preliminary, unpublished findings from his review of records of patients in California covered by the Medicaid health insurance programme for the poor.

The data showed Celebrex likely increases the chances of heart attacks when taken at higher doses, but Bextra does not appear to carry that risk at its approved doses of up to 20 milligrams. He said the Bextra findings were based on a small amount of data.

Graham?s review linked Celebrex to a ?probable increased risk? of heart attacks in higher doses, but ?no apparent effect? if patients take 200 mg doses or less. Celebrex is sold at doses of 100 mg, 200 mg and 400 mg.