Lawmakers Question Merck,
FDA Over Vioxx
Fri Oct 15, 2004 06:11 PM ET
WASHINGTON (Reuters) - A leading U.S. Senate Republican
this week demanded internal documents from Merck & Co. Inc. (MRK.N: Quote,
Profile,
Research)
that could answer questions about the company's interaction with U.S.
regulators over its arthritis drug Vioxx.
Senate Finance Committee Chairman Charles Grassley called for the
information on Thursday as part of an investigation into the safety
monitoring of the medication, which the company pulled from the market
after it was shown to cause heart problems.
The U.S. Food and Drug Administration and Merck had an agreement where
the agency would "give the drug company a head's up when the federal
agency planned to publish a drug study that might negatively affect the
drug company," Grassley said is a statement on Friday.
Merck spokesman Tony Plohoros said the Whitehouse Station, New
Jersey-based drug maker "intends to cooperate fully with Senator
Grassley's inquiry."
FDA spokeswoman Crystal Rice said the agency had no comment on the
letter.
Grassley, an Iowa Republican, cited e-mails from Dr. Anne Trontell,
FDA's deputy director of drug safety, that questioned the efforts of FDA
scientist David Graham, who concluded that patients taking Vioxx had a
higher risk of heart attacks and sudden cardiac death than those on Pfizer
Inc.'s (PFE.N: Quote,
Profile,
Research)
rival medicine Celebrex.
In those those e-mails, Trontell said the company needed to know about
the results before they became public, according to Grassley.
Trontell could not be immediately reached by phone and did not
immediately reply to an e-mail request for comment. Graham, reached by
telephone, said he could not comment on the letter.
"Given the 'agreement' between the FDA and Merck, as well as the timing
of events surrounding Merck's withdrawal of Vioxx, many questions come to
mind, specifically: who knew what and when?," Grassley wrote in a letter
dated October 14 and sent to Merck's President and Chief Executive
Officer, Raymond Gilmartin.
Last week Grassley interviewed Graham, the associate director for
science in the FDA's Office of Drug Safety, who said he felt intimidated
by others at the agency when he tried to get his research published,
according to the senator.
Merck shares closed up 31 cents, or about 1 percent at $30.50 on the
New York Stock Exchange on Friday, a day when drug stocks closed up about
0.38 percent, or $1.11, on the American Stock Exchange Pharmaceutical
Index.
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