File Shows Merck Sought to Change Vioxx

Merck & Co. researchers privately sought to reformulate Vioxx in 2000 to reduce its cardiovascular side effects even as the drug maker was publicly playing down a study that highlighted the pain relief medication’s potential heart attack risk, an internal company document shows.

The widely publicized study in March 2000 found that patients taking Vioxx were five times more likely to have heart attacks than individuals using the generic medicine naproxen. Merck insisted at the time that this was a result of naproxen’s cardioprotective properties and not any defect in Vioxx.

But behind the scenes, company 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 Merck to plaintiff lawyers as part of the evidence-gathering process in one of the hundreds of Vioxx lawsuits around the country.

That document, a communication between Merck researchers and the company’s patent department, said the way Vioxx works to reduce pain also might increase cardiovascular problems. They suggested that a patent be sought for a combination drug mixing Vioxx with another agent to lessen the risk.

Merck removed Vioxx from the market in September after a later study showed that it doubled patients’ risk of heart attacks and strokes. Thousands of wrongful death and injury lawsuits have been filed against Merck based on claims that the company hid Vioxx’s risks. Analysts estimate the company’s liability could reach as much as $18 billion. The first trial is set to begin in July in Angelton, Texas.

The document is potentially among the most damaging to emerge since the drug’s sales were suspended because it calls into question the bedrock Merck defense that company executives 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. “Should they have been open about concerns? The failure to be honest is what gets companies” in product liability cases in trouble.

A copy of the document was provided to Associated Press on the condition that its source not be identified. Although ruled inadmissible in a Vioxx case in New Jersey, where it first came to light, the memo could be allowed in other trials.

A lawyer for Merck declined to discuss the specifics of the document, contending that it was a privileged internal company discussion.

“We continue to believe we acted responsibly,” said Merck spokeswoman Cynthia Smith.

Merck shares fell 1 cent to $31.98 on Wednesday.