Sen. Chuck Grassley Asks Merck CEO, Acting FDA Commissioner To Testify at Congressional Hearing on Vioxx
Senate Finance Committee Chair Chuck Grassley (R-Iowa) on Wednesday called on Merck CEO Raymond Gilmartin and FDA acting Commissioner Lester Crawford to testify at a Nov. 18 congressional hearing on actions that the company and the agency took to inform the public about the cardiovascular risks associated with the COX-2 inhibitor Vioxx, Reuters/New York Times reports. Merck in late September voluntarily withdrew Vioxx from the market based on a study that indicated the medication doubled patient risk for heart attack and stroke (Reuters/New York Times, 11/11). However, some researchers have said that Merck had evidence about the safety risks of Vioxx as early as 2000 (Hall, Detroit News, 11/11).
House Government Reform Committee Chair Tom Davis (R-Va.) on Wednesday said that he has asked Gilmartin to provide the committee with all records related to an FDA committee review of Vioxx and other documents, such as communications between the company and the agency. Grassley said, "The agency must address what looks like systemic problems when it comes to putting public health and safety first and public relations second."
FDA spokesperson Kathleen Quinn said that the agency will review the request from Grassley. Merck spokesperson Tony Plohoros said that the company "intends to cooperate with government inquiries" but has "not yet determined" whether Gilmartin will testify at the congressional hearing.
Senate Finance Committee spokesperson Jill Gerber said that Merck has not requested to substitute an official to testify in place of Gilmartin. She said, "He's the one we invited, and he's the one we expect" (Reuters/New York Times, 11/11).
Gilmartin in an interview on Wednesday said the company will "absolutely survive" the Vioxx withdrawal. He also said that he was aware of data that indicated Vioxx could increase patient risk for cardiovascular problems from a clinical trial sponsored by the company only six days before the withdrawal of the medication.
In addition, Gilmartin said, "At every step of the way, we did the right thing. We studied the drug extensively. Whenever we found something positive or negative about the drug, we disclosed it promptly. Doing the right thing is something that we can always point to." He added, "You would expect, from a scientific standpoint, rigorous debate within the company based on the data at the time and changing positions based on new data. This reflects a relentless effort to find out what was going on and if there was a safety problem. Within a week of finding out of the increased risk, we pulled the drug from the market."
Gilmartin said, "I'm quite enthusiastic and confident about the future of this company and what it is capable of doing." He predicted that sales from five medications expected to reach the market in the next two years -- such as a cervical cancer vaccine and a diabetes treatment -- would help Merck overcome the loss of Vioxx.
However, some analysts maintain that Merck "faces vast financial problems in the future," according to the Detroit News (Detroit News, 11/11).