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Panel Found Vioxx Risks After 4 Months

Feb 8, 2005 | Star Ledger

Newly disclosed documents indicate a committee overseeing a key Vioxx study found increased risks of various heart problems in patients after just four months, according to a published report.

At the time Merck yanked Vioxx last September, the Whitehouse Station-based drug maker said a fresh review of the same clinical trial data only found significant evidence of heart attacks or strokes after patients took the medication for 18 months.

However, the committee members expressed concern in meeting notes about a trend showing the possible effect of Vioxx on heart attacks and strokes, according to the report. The first meeting took place in January 2002, nearly two years before Vioxx was withdrawn.

In addition, the committee reportedly included one Merck employee and two doctors who had ties to the drug maker. Despite signs of heart problems, the report said the committee kept the trial going to determine whether Vioxx would be useful in treating colon polyps.

The new information, which was first reported in the Wall Street Journal, is the latest sign Merck will face a tough and protracted battle over its liability in a mounting number of lawsuits brought by Vioxx patients.

The company has already been hit with nearly 600 lawsuits from people who claim they were harmed by the painkiller, which is one of the so-called Cox-2 drugs along with Celebrex. Next week, a regulatory advisory panel will review the safety of these medicines.

Merck is accused in the lawsuits of attempting to downplay the risks of heart problems before Vioxx was launched in 1999, and continued to do so after researchers and physicians questioned the drug's safety.

In a statement, a Merck spokesman said appropriate standards were used to conduct the study and it stood by the actions of the committee, whose job was to evaluate how patients responded to Vioxx at various study sites.

Two committee members who reportedly had ties to Merck; David Bjorkman of the University of Utah School of Medicine and Marvin Konstam, chief of cardiology at the Tufts-New England Medical Center couldn't be reached for comment on their ties to Merck.

Yesterday, the lead researcher in the Vioxx trial, John Baron, a professor of medicine at Dartmouth Medical School, said the rate of heart problems detected in the early stages of the trial weren't statistically significant.

He also noted such side effects as hypertension and fluid retention, which can lead to congestive heart failure, are different types of events than heart attacks or strokes.

"The contention that Merck should have stopped the study is naive or deliberately misleading," Baron said.

Baron was reportedly quoted in an internal Merck e-mail in 1999 as saying the purpose of the committee was "50 percent scientific need and 50 percent for appearances." Yesterday, he said he couldn't remember making the remark, adding that independent safety committees provide needed credibility.

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