Merck Dismissed Earlier Vioxx® Warnings

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Merck forced one of its researchers to remove her name from a study linking Vioxx® to heart attacks, then criticized the findings before ultimately pulling the arthritis drug from the market last fall, two of the scientist's colleagues said.

"Even after funding and agreeing with the design of the study, Merck publicly discredited our findings," Dr. Daniel Solomon and Dr. Jerry Avorn of Boston's Brigham and Women's Hospital wrote in this week's Archives of Internal Medicine.

Merck spokeswoman Anita Larsen confirmed the company's action, saying Merck believed the study's conclusions "were not supported by the data." The incident came about six months before another study prompted the drugmaker to withdraw Vioxx®.

The journal contains several studies about Vioxx® and Celebrex®, the once popular and heavily promoted painkillers. One new report echoes previous data suggesting that in some older patients the drugs might not offer as much protection as thought against gastrointestinal problems. A separate study suggests they have been over-prescribed, frequently to patients at lower risk for gastrointestinal problems. And other research supports evidence that Vioxx® increases some patients' blood pressure.

The author-removal incident, mentioned in previous news reports, involved a Merck study of more than 50,000 patients age 65 and older taking Vioxx®, Celebrex®, traditional painkillers or none of the drugs. The results, published last year in the journal Circulation, showed Vioxx® patients faced a higher heart attack risk than the other groups.

When the results came in, "Merck required a co-author who was an employee of the company to remove her name from the article immediately prior to publication," Solomon and Avorn said in an Archives editorial.

Solomon identified the co-author as Merck epidemiologist Carolyn Cannuscio. Larsen said publication policies at Circulation and Merck allowed the drugmaker to remove the employee's name "if the authors draw conclusions that are not supported by the data." She said Cannuscio agreed with Merck's decision.

Meanwhile, the British medical journal is releasing a study on the heart dangers of Vioxx® after withholding the report because the researcher said he had been threatened by his superiors at the FDA.

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