During his 20 years in the Office of Drug Safety, he fought passionately to bring about the recall of the diabetes drug Rezulin, the diet pills Fen-Phen and Redux, the cholesterol-lowering drug Baycol, the heartburn remedy Propulsid, and the antihistamine Seldane.
Graham, 50, was trained as a physician at Johns Hopkins and Yale universities and has spent his entire career at the FDA's drug safety office. A deeply religious Roman Catholic, he has said that his faith serves as a spur to his work. Some see him as a crusading hero, while others believe he unfairly fixates on certain drugs and fails to take into account the patients who are helped by those medications.
David J. Graham, a drug safety official at the Food and Drug Administration, told a Senate hearing that FDA policies have left the American public "virtually defenseless" against the kind of safety problems that led to the withdrawal in September of the popular arthritis drug Vioxx.
(Kevin Lamarque -- Reuters)
|
|
His influence has been enormous. In his congressional testimony, Graham said that, in the course of his career, he had recommended that 12 drugs be taken off the market, and that 10 of them were subsequently removed.
The news that Graham had sought whistle-blower assistance and protection -- and that FDA managers had sought to undermine his credibility -- was first reported yesterday in the online edition of BMJ, formerly known as the British Medical Journal.
In that account, Devine said the FDA was "employing a classic law of whistleblower reprisal -- the smokescreen syndrome -- which shifts the spotlight from the message to the messenger. The agency attempted to discredit Dr. Graham rather than provide any scientific evidence contradicting his conclusions."
Graham could not be reached yesterday for comment.
One of the two drugs whose recall Graham has unsuccessfully sought is Accutane, which was approved to treat severe acne but, critics say, is widely prescribed for milder cases. The drug's distribution is restricted to prevent its use by pregnant women because Accutane can cause fetuses to die or develop birth defects. Nonetheless, some women have been getting pregnant while taking the drug.
Under an expanded monitoring program announced by the FDA yesterday, manufacturers will have to keep records of which doctors prescribe the drug, which pharmacies distribute it and which patients take it. Doctors and pharmacies will also have to inform women about the drug's risks, and pharmacists will have to see a signed proof that the patient is not pregnant before they dispense the drug, the FDA said.
In its news release, the agency said the changes stemmed from the recommendations of an advisory panel in February.
