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Saturday, September 17, 2005

Merck's Vioxx, Similar Drugs Lead to Blood Clots, Expert Says

Sept. 16 (Bloomberg) -- Merck & Co.'s Vioxx and similar drugs promote blood clotting that can lead to heart attacks and strokes, a medical professor testified at the second product- liability trial over the painkiller.

Benedict Lucchesi, a University of Michigan pharmacologist, was the first expert to testify for Frederick Humeston, who is suing Merck over his 2001 heart attack. Lucchesi said Vioxx and similar drugs, known as Cox-2 inhibitors, can cause blood clots, or thromboembolisms, that break loose and plug blood vessels.

``The probability is very high that Vioxx and other Cox-2 inhibitors, but mostly Vioxx, can lead to the development of thromboembolic events,'' Lucchesi testified today in Atlantic City, New Jersey. ``There is a big probability that Vioxx does pose a risk to patients with underlying disorders.''

Lucchesi's testimony supported Humeston's claim that Merck had warnings about the dangers of Vioxx years before withdrawing it last year because of health concerns. Merck, which faces about 5,000 Vioxx suits, could face billions of dollars in liability if it loses several early trials, analysts say.

Merck, based in Whitehouse Station, New Jersey, says it had no scientific proof of the dangers of Vioxx before last September, when a study showed it doubled the risk of heart attacks and strokes after 18 months of use. Humeston, a 60-year- old postal worker from Idaho who used Vioxx for two months, had a heart attack because of his weight, blood pressure and work- related stress, the company contends.

Lucchesi testified at the Texas trial at which jurors returned a verdict saying Merck should pay $253 million to the widow of a man who took Vioxx. That amount will be reduced to $26 million under state law.

Cox-2 Inhibitors

Lucchesi described his 50-year medical career, which included helping to develop pacemakers. He told jurors about the working of the heart and how drugs affect it, and he recounted the development in the 1990s of Cox-2 inhibitors -- so called because they inhibit an enzyme with that name -- to prevent the stomach bleeding caused by other painkillers.

Vioxx was launched in May 1999. It later generated $2.5 billion in annual sales for Merck, the No. 3 U.S. drugmaker.

In questioning Lucchesi, Humeston's lawyer Christopher Seeger showed jurors the minutes of a 1998 meeting by a Merck scientific advisory board warning that drugs like Vioxx could lead to a buildup of plaque and clots in the blood. It urged Merck executives to study the problem further.

Lucchesi reviewed a 1999 letter by a Vanderbilt University pharmacologist, John A. Oates, to Merck's former top scientist, Edward Scolnick. In that letter, Oates described four patients who had heart attacks or strokes while taking a Cox-2 inhibitor.

`Be Cautious'

``He's telling Merck that you have to be cautious,'' Lucchesi told jurors. ``You have to identify patients who would be at high risk.''

Lucchesi testified after Merck's lawyers challenged his qualifications and said he had no evidence that Vioxx had posed a statistically significant increased risk of causing Humeston's heart attack.

Superior Court Judge Carol Higbee said the request came too later, calling it ``way, way, way beyond untimely.'' She said Merck could challenge his testimony later.

The case is Humeston v. Merck & Co., L-02272-03, Superior Court, Atlantic City, New Jersey.

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