When Did Merck Know Vioxx Was Deadly?
Study Finds Danger Signal in Early Merck Data; Merck Says Study Flawed
"We fundamentally disagree with their conclusions that there was an actionable signal before September 2004," Doug Watson, PhD, senior director of medical science for Merck Research Laboratories, tells WebMD.
Watson says that when Merck looked at the data, its researchers were much more thorough than Ross and colleagues. Most importantly, Watson says, the company used independent evaluators to determine whether adverse events were truly related to heart attack or stroke, and whether deaths were due to heart attacks or strokes or to non-Vioxx-related causes such as infections or trauma.
"We disagree with their conclusions that there was a finding that should have resulted in earlier action on our part, because we disagree with the methods they use," Watson tells WebMD. "We investigated Vioxx while it was on the market ... based on the most rigorous scientific methods, vetted with the FDA, and we did not see a signal prior to the APPROVe study."
Ross defends his team's methods as the best way to look for a safety signal. He notes, for example, that if a patient on Vioxx died due to an accident, it may very well have been a heart attack that led to the accident. And he points to the fact that the heart/stroke risk of Vioxx is now a widely accepted medical fact -- and that Merck's studies failed to detect this risk until some 20 million people had taken the drug.
Ross says the real message of the study is not to point fingers at Merck. The point, he says, is that routine safety evaluations -- using all clinical data, not just published data -- should be performed on all new drugs.
"What we are saying is this kind of study should be done routinely, particularly when there is a known safety concern about a drug," Ross says. "This safety monitoring is not rocket science. We would be protecting the publics' health because we would be identifying risks earlier."
Federal law enacted since the Vioxx debacle now requires companies to disclose clinical trial data to the public within 12 to 24 months of study completion.
In late September, Merck settled more than 3,000 Vioxx lawsuits in a $4.85 billion settlement. That reversed a company policy of fighting each lawsuit one at a time, even though the company has won most of these suits.