Merck's Vioxx defense was dealt a blow when the discovery of an internal document from 2000 revealed that the company considered reformulating the drug to reduce its cardiovascular risks, according to an Associated Press report.
The document, a communication between Merck researchers and the company's patent department, stated the way Vioxx works to reduce pain might also increase cardiovascular problems. Researchers suggested a patent be sought for a combination drug mixing Vioxx with another agent to lessen the risk.
The document was mistakenly provided by Merck plaintiff lawyers as part of the evidence-gathering process in one of the hundreds of Vioxx lawsuits filed around the country and is considered to be the most damaging to emerge because it calls into question Merck's defense that company officials were convinced of the drug's safety.
According to the document, Edward Skolnick, the former head of Merck's research labs, was the first to suggest reformulating Vioxx with an agent that would block blood platelets from clotting. Such clots can lead to heart attacks and strokes.
Merck filed an application with the U.S. patent office in 2001 to combine Vioxx with a thromboxane inhibitor, according to a statement released yesterday by Merck's counsel, Hughes, Hubbard & Reed. The statement said the hope was that Vioxx could provide cardiovascular protection while preserving its gastrointestinal benefits. The project was later dropped rendering the patent application moot.
A Merck spokeswoman told the AP that the company continues to believe "We acted responsibly."
Merck voluntarily withdrew Vioxx from the market last September after a later study found it doubled patients' risk of heart attacks and strokes. Thousands of wrongful death and injury lawsuits have been filed against Merck based on claims the company hid the risks of Vioxx. Analysts have estimated that the company's liability could reach as high as $18 billion. The first trial is set to begin next month in Angleton, Texas.