NEW YORK (CNN/Money) -
Merck and federal regulators came under fire Thursday for their handling of Vioxx but the drugmaker's CEO staunchly defended the company's withdrawal of the drug after increased risks of heart attacks and strokes were found.
At a hearing on Capitol Hill, Senate Finance Committee Chairman Sen. Charles Grassley accused the Food and Drug Administration of ignoring warnings from its own scientists regarding Vioxx, which was one of the world's most widely prescribed medications before Merck pulled it off the market on Sept. 30.
Grassley said the FDA had a "far too cozy" relationship with drugmakers, which could have led the agency to ignore warnings from its own scientists about Vioxx.
He also said an independent U.S. office of drug safety may be needed to separate monitoring drug safety from new drug approval.
"My investigators have come up with information that both before Vioxx went on the market and even after Vioxx went on the market there were various red flags coming up within the organization of Merck that raised these legitimate questions about the safety of the drug," Grassley, an Iowa Republican, said on CNNfn before the hearing started.
An FDA scientist testifying at the hearing in Washington identified drugs other than Vioxx that he said needed more study, among them the cholesterol-lowering drug Crestor and the painkiller Bextra. But another FDA official told lawmakers that she disagreed. (For more on the drugs cited, click here).
Merck readies its defense
Merck (Research) Chairman and CEO Raymond Gilmartin insisted at the hearing that Merck pulled Vioxx as soon as the company had proof of the health risks.
"Withdrawing Vioxx was consistent with an ethic that has driven Merck actions and decisions for more than 100 years. Merck puts patients first," Gilmartin told the committee.
In response to a question, he said it was impossible to give "any reliable estimate" of the number of people harmed or killed as a result of taking Vioxx. Asked about some studies showing the drug caused harm, Gilmartin said, "All those estimates are just speculation."
|Sen. Chuck Grassley, chairman of the Senate Finance Committee, comments on Thursday's testimony on the withdrawn Merck drug.|
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Merck launched Vioxx in 1999, and it had worldwide sales of $2.5 billion last year. The company is expected to face a flood of lawsuits from people who believe they were injured or a family member died because of the drug.
The New York Times reported Thursday that almost a year before Merck pulled the drug, company officials had received preliminary results from a study that apparently indicated the drug posed cardiovascular risks.
The newspaper quoted a company spokeswoman as confirming the study's existence, adding that Merck, which paid for the study, received its preliminary results in November 2003. The spokeswoman said the study was inconclusive because it was based on patient records and not on an actual clinical trial.
FDA under fire
Grassley was not the only one criticizing regulators' performance on Vioxx Thursday.
"The FDA has let the American people down," said Dr. David Graham, an FDA drug safety reviewer who co-authored a study that criticized Vioxx and recommended it be pulled from the market.
Graham told lawmakers that the FDA pressured him to change the recommendation in his study and to inform Merck of his findings. But he was determined to get the information out.
"I thought if I didn't, that data would never see the light of day," Graham told lawmakers.
But Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, testified she does not agree with Graham.
"I believe all drugs pose some safety risks," she said. Vioxx, for instance, was shown to provide gastrointestinal tract benefits. "You can't just look at the cardiovascular risks of this drug," she added.
The FDA's first study of Vioxx found a nearly seven-fold heart attack risk in low dose use of the painkiller, according to Graham.
A second trial, the Vigor study, initiated by Merck after the drug was on the market, found a five-fold increase with high dosages, Graham said, adding the findings didn't prompt the FDA to put new information in the warning section on Vioxx packaging or ban high-dose use.
In his remarks, Gilmartin defended Merck's actions.
"When we received the results of the Vigor study, we promptly issued a news release providing its conclusions and we submitted its results to the FDA," he told the panel. "Just two months later, we submitted the initial Vigor results to the New England Journal of Medicine for publication and presented the data at a major scientific meeting."
But Graham contended that tests of the drug were poorly designed -- noting, for example, that Vioxx was tested on younger, healthier subjects instead of on elderly people who were more likely to receive the drug.
"These studies do not protect Americans...they protect the drug," he said.
Gilmartin said he disagreed with the portrait of the FDA painted during the hearing, calling the FDA a "very tough regulator."
In addition to Crestor, marketed by AstraZeneca, and Pfizer's Bextra, Graham cited Roche's acne drug Accutane, GlaxoSmithKline's asthma medicine Serevent and Abbott's Meridia for weight loss as needing further scrutiny.
Merck (up $0.02 to $27.36, Research) stock closed little changed. But its stock is off about 40 percent since Vioxx was pulled.