October 07,2004

Chairman Grassley comments on interview with FDA researcher on Vioxx


TO: Reporters and Editors
FR: Jill Kozeny
RE: FDA, Vioxx
DA: October 7, 2004

As part of an ongoing investigation into how the Food and Drug Administration handled information about safety issues concerning the drug Vioxx, Finance Committee investigators for Senator Chuck Grassley today interviewed FDA researcher David Graham. Dr. Graham isassociate director for science in the FDA Drug Center's Office of Drug Safety. Senator Grassleyis chairman of the Committee on Finance. Based on today's meeting, Senator Grassley issued thefollowing comment.

"As my investigative staff continues looking into how the Food and Drug Administrationhandles drug safety issues, particularly with antidepressants and Vioxx, a picture is emerging ofan agency that can't see the forest for the trees.

"Dr. Graham's study and conclusions may have triggered Merck to take necessary actionon Vioxx. Dr. Graham said today that during the last month he's been fighting an uphill battlewithin the Food and Drug Administration to let his study see the light of day. He described an'FDA clearance process' that was he felt was trying to block the publication of his manuscript.Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and'intimidation.' When the Director of the Office of New Drugs suggested watering down Dr.Graham’s conclusions Dr. Graham wrote, 'I’ve gone about as far as I can without compromisingmy deeply-held conclusions about this safety question.' On August 12th of this year, before hisfindings were presented, Dr. Graham's supervisor wrote that Merck 'needs to know before itbecomes public so they can be prepared for extensive media attention that this will likelyprovoke.'

"So it seems that while Merck was taking a fresh look at its clinical data in search oftrouble, the Food and Drug Administration was challenging its own researcher. Merck knew ithad trouble on its hands and took action. At the same time, instead of acting as a publicwatchdog, the Food and Drug Administration was busy challenging its own expert and calling hiswork 'scientific rumor.'

"What Dr. Graham went through is similar to what we now know another FDA scientist,Dr. Mosholder, went through when he wanted to let the public know about a link betweenantidepressants and suicide in young people. In both cases, what looks like foot dragging by theFood and Drug Administration is downright alarming. Is the Food and Drug Administrationdropping the ball in protecting the safety of the American people?"