Merck Says It Decided Against Vioxx Study Three Years Ago

Feb. 9–Merck & Co. three years ago proposed, but ultimately decided against, a study of its withdrawn painkiller Vioxx that would have specifically looked at the drug’s cardiovascular risks.

Instead, the drug maker, which detailed its decision in a filing posted Friday on the Web site of the Food and Drug Administration, decided to gather data of Vioxx’s heart effects through other studies evaluating its impact on various cancers. Data from one of those trials led Merck to withdraw the drug from the market Sept. 30 because of increased risks of heart attack and stroke.

In an article Tuesday, The New York Times cited other company documents that said the canceled Vioxx study could have provided answers to Vioxx’s risks in March of last year or earlier.

In response, Cynthia Smith, a Merck spokeswoman said: “We don’t believe that the particular study would have necessarily provided cardiovascular data sooner.”

Merck’s handling of the Vioxx withdrawal is being probed by federal investigators with the Department of Justice and Securities and Exchange Commission, as well as by congressional committees. As of Dec. 31, Merck said it was named as a defendant in about 575 personal injury lawsuits involving 1,400 plaintiff groups — numbers that are sure to grow.

Merck’s discussion of its proposed cardiovascular study was part of a 176-page “background document” on Vioxx submitted to the FDA. The agency posted the document in advance of a meeting next week to discuss Vioxx’s class of painkillers, which also includes the Pfizer drug Celebrex.

Merck announced in December 2001 that it would conduct a study looking at the cardiovascular effects of Vioxx. The announcement followed another study, known as Vigor, which showed increased risk of heart problems with Vioxx as compared with another painkiller, naproxen. Merck has said that it believed that naproxen is beneficial to the heart, which made Vioxx look worse by comparison.

Merck considered “several designs” for a cardiovascular study comparing Vioxx to a placebo, according to the document submitted to the FDA. One proposal was in high-risk patients with acute coronary syndrome, an umbrella term that covers a group of symptoms, according to the American Heart Association.

There was the possibility that anti-inflammatory drugs in Vioxx’s class could benefit patients in acute coronary syndrome.

After consulting outside experts, Merck rejected the study design for several reasons. The patients in the study would be “medically unstable” and the risk of causing gastrointestinal complications “was considered excessive in comparison to the potential benefit.” Also, all of the patients would be taking aspirin, which has heart-protective effects that could make it more difficult to determine the results. Finally, it was unclear how to “extrapolate” the data to arthritis patients.

Smith said the company had informal talks with the FDA regarding the proposed cardiovascular study in February 2002. Soon after, the company decided against the study in favor of another approach to gathering cardiovascular data from a combined analysis of results from three other cancer studies.

The earliest of those studies began in 2000 and looked at preventing colon polyps. Merck halted the study and pulled the drug after the trial showed an increased risk of heart attack and stroke after 18 months.

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