Merck Document Shows Internal Researchers Wanted Safer, Reformulated Vioxx®

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An internal document shows that Merck researchers privately sought to reformulate Vioxx® in 2000 to reduce its cardiovascular side effects, even as the drug maker was playing down a study that highlighted painkiller's potential heart attack risks.

The 2000 drug study found that patients taking Vioxx® were five times more likely to have heart attacks than individuals using the painkiller naproxen. Behind the scenes, Merck scientists were considering combining Vioxx® with another agent to reduce the risk of heart attacks and strokes, according to a document that was mistakenly provided by the company to plaintiff lawyers as part of the evidence gathering process in one of the many Vioxx® lawsuits around the country.

That document, a communication between Merck researchers and patent department, stated that the way Vioxx® works to reduce pain may also increase cardiovascular problems. The researcher's suggested a patent be sought for a combination drug mixing Vioxx® with another agent to lessen the risk.

This document is particularly important as it calls into question Merck's defense that company officials were convinced of the drug's safety. The desire to reformulate the drug suggests a level of urgency that goes beyond previously disclosed internal e-mails that discussed safety risks.

"The document suggests a level of concern about the drug. The fact that they wanted to patent a different product raises questions - it says something," said Anthony Sebok, a professor at Brooklyn Law School.

The Associated Press has obtained a copy of the document that Edward Scolnick, former head of Merck's research labs, was the first to suggest combing Vioxx® with an agent that would block blood platelets from clotting. These clots can lead to heart attacks and strokes.

The other authors of the document said Vioxx® might reduce the production of prostacyclin, which prevents platelet aggregation. That reduction may alter the ratio of prostacyclin to thromboxane, a substance which can constrict blood vessels and cause clotting. The change may cause increased risk of cardiac and cerebral adverse events, the document said.

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