Senator Wants to Find Out Where FDA was on Vioxx

posted on:
November 19, 2004


U.S. Senator Charles Grassley said he wants to find out why the Food and Drug Administration didn’t pursue safety concerns about Merck & Co.’s painkiller Vioxx, the biggest drug ever recalled.

“They had their own scientists raising questions about it that they tried to suppress—the scientific evidence that Vioxx wasn’t safe,” Grassley, an Iowa Republican, said in an interview on Capitol Hill.

Grassley chairs the Senate Finance Committee, which will hold a hearing on Vioxx today in Washington. Merck withdrew Vioxx Sept. 30 after a three-year study found that long-term use of the drug doubled a person’s risk of heart attack and stroke.

The committee is taking a closer look at drug safety as Medicare, the government insurance plan for the elderly and disabled, prepares to more than double spending on prescription drugs to almost $26 billion in 2006. Medicaid, which provides health coverage for the poor, spent more than $1 billion on Vioxx from 1999 until the drug was pulled, the panel estimates.

Merck Chief Executive Officer Raymond Gilmartin is scheduled to appear at the hearing, as is David Graham, the FDA reviewer who wrote a report linking Vioxx to 27,785 heart attacks and deaths. Acting FDA Commissioner Lester Crawford won’t appear because he’s scheduled to testify at another congressional hearing on the influenza vaccine shortage, Grassley spokeswoman Jill Kozeny said.

“It may sound like I’m putting all my emphasis on Merck, but it has legitimacy having focus on the Food and Drug Administration not doing its job and protecting the public,” Grassley said in the interview.

Vioxx generated $2.5 billion in sales for Readington-based Merck last year, about 11 percent of total revenue. Gilmartin said in an interview Monday that his first indication that Vioxx carried a heart risk came on Sept. 23, a week before the recall.

Plaintiff’s lawyers, including Andy Birchfield Jr. of Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Ala., have said internal documents show Merck was concerned about potential for a heart risk even before the drug went on sale.

Since the recall, Merck’s market value has plummeted by almost $40 billion, its debt has been downgraded, thousands of lawsuits alleging injury by Vioxx have been filed, and the Justice Department and Securities Exchange Commission have started probes.

Merck shares fell 14 cents to $27.34 in New York Stock Exchange Composite trading yesterday.

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