November 10,2004

Grassley to Convene Hearing on Worldwide Withdrawal of Vioxx

Event: Committee on Finance Hearing, “FDA, Merck, and Vioxx: Putting Patient SafetyFirst?”
Date/time: Thursday, Nov. 18, 2004, at 10 a.m.
Location: 215 Dirksen Senate Office Building, Washington, D.C.

Description: In the past year, Sen. Chuck Grassley, chairman of the Committee on Finance, hasbeen examining whether the Food and Drug Administration has made fundamentalmistakes in managing public health risks with antidepressants in children and, mostrecently, with Vioxx, the pain medication for arthritis just withdrawn from the marketover concerns that it increases the risk for heart attack and stroke. Grassley isconcerned that the American public has been kept in the dark. With more Americansrelying on prescription drugs than ever before, and with federal programs Medicareand Medicaid poised to pay for more prescription drugs than in history, Grassleyfeels a critical look at drug safety and the worldwide withdrawal of Vioxx is overdue.The hearing will mark the first time the leaders of the FDA and Merck, maker ofVioxx, will testify on Capitol Hill about Vioxx’s safety problems.

“Like most Americans, I’ve always thought that when the FDA approves a drug, it’slike the good housekeeping seal of approval,” Grassley said. “If the drug’s not safe,the FDA would know and take it off the market. The alarming revelations aboutVioxx make me a whole lot more skeptical. It looks like the FDA and Merck saw alot of red flags from the beginning. The agency must address what looks likesystemic problems when it comes to putting public health and safety first and publicrelations second. And Merck must stand up and set the record straight about what itknew about cardiovascular risks associated with Vioxx and when the company knewit. It appears that life-and-death decisions are being made behind closed doors. TheAmerican people should never be the last to know that their lives are at risk whentaking a prescription drug.”

The witness list follows

David J. Graham, MD, MPH, Associate Director for Science, Office of Drug Safety, Center for Drug Evaluation and Research, U.S. Department of Health and Human Services, Food and Drug Administration, Washington, D.C.

Gurkirpal Singh, MD, Adjunct Clinical Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University School of Medicine, Stanford, Calif. (viavideoconference) – Dr. Singh is a former Merck consultant with extensive knowledge and expertise on Vioxx.

Bruce M. Psaty, MD, PhD, Professor, Medicine & Epidemiology, University of Washington,Cardiovascular Health Research Unit, Seattle, Wash. – Dr. Psaty has extensive knowledge ofcardiovascular disease and epidemiology and will discuss various Vioxx studies and trials.

Lester M. Crawford, DVM, PhD, Acting Commissioner, U.S. Department of Health and HumanServices, Food and Drug Administration, Washington, D.C.

Dr. Raymond V. Gilmartin, Chairman, President & Chief Executive Officer, Merck & Co., Inc.,Whitehouse Station, N.J.