"However," he told the audience, "what’s come to light about Vioxx since September 30th makes people wonder if the FDA has lost its way when it comes to making sure drugs are safe."
It looks like the FDA, he said, allowed itself to be manipulated by Merck on labeling changes that became necessary after a review by Merck that’s known as the VIGOR trial.
He explained how Merck completed the VIGOR trial in March 2000 and gave the findings to the FDA in June 2000, and was the subject of an advisory board meeting in February 2001. "But it was April 11, 2002," he told the audience, "before the Vioxx label was actually changed."
"During these 22 months," Senator Grassley said, "Merck aggressively marketed Vioxx, knowing that consumers and doctors were largely unaware of the cardiovascular risks found in the VIGOR trial."
The bottom line is, consumers should not have to second guess the safety of what's in their medicine cabinets," he said. "The public should feel confident that when the FDA approves a drug, you can bank on it being safe, and if a drug isn't safe, the FDA will take it off the market."
The first witness called to testify at the hearing, was Dr David Graham, a scientist with an 18 year career at the FDA, who blew the whistle on the FDA' s handling of the safety issues related to Vioxx.
Right off the bat, he warned the committee: "we, are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world."
He called the Vioxx tragedy "a profound regulatory failure."
"It is important," Dr Graham said, "that this Committee and the American people understand that what has happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people."
"Simply put," he told the panel, "FDA and its Center for Drug Evaluation and Research are broken."
Dr Graham discussed the studies that demonstrated that Merck and the FDA were aware of the Vioxx risks since before the drug was approved.
He told the panel of a Merck study named 090, that found a nearly 7-fold increase in heart attack risk with low doses of Vioxx conducted before the drug was approved and yet the labeling at the time of FDA approval said nothing about the risks.
In November 2000, he said, the VIGOR study found a 5-fold increase in heart attack risk with high-doses of Vioxx and yet the company said Vioxx was safe.
In fact, it was not until about 18 months after the VIGOR trial was published, that the FDA made a label change to include the heart attack risk, but even then the agency did not place it the “Warnings” section.
"Of note," Dr Graham told the committee, "FDA’s label change had absolutely no effect on how often high-dose Vioxx was prescribed, so what good did it achieve?"
He informed the panel that a large study in 2002 also reported a 2-fold increase in heart attack risk with high-doses of Vioxx.
