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Merck's Vioxx Posed Extraordinary Risk, Cardiologist Contends

Dec 3, 2005 | Bloomberg

Merck & Co. ignored warning signs that its Vioxx painkiller posed an ``extraordinary risk'' of causing heart attacks in users, a cardiologist testified today in the first federal trial over the drug.

Dr. Eric Topol, head of cardiovascular medicine at the Cleveland Clinic, said a 2000 Merck study showed patients faced an increased risk of suffering a heart attack or stroke after as little as four weeks of use. Merck, which began selling Vioxx in 1999, pulled it off the market in September 2004 after other studies highlighted the potential for heart problems.

``There was not any question about'' the link between Vioxx and heart ailments, Topol said in videotaped deposition shown to a federal jury in Houston hearing claims the drug caused a Florida man's death. That meant Vioxx sales posed ``an extraordinary risk'' for some users, Topol added.

Topol's testimony comes as Merck is seeking its second win in lawsuits over Vioxx. Last month, a New Jersey jury found Vioxx wasn't to blame for a postal carrier's heart attack that followed his short-term use of the drug. In the Houston case, the family of Richard ``Dicky'' Irvin contends his use of Vioxx for 23 days led to his fatal heart attack.

Merck has set aside $675 million to fight about 7,000 Vioxx suits already filed. A judge overseeing federal Vioxx cases has estimated the company eventually may face than 100,000 such suits. The shares have fallen 33 percent since Merck pulled Vioxx off the market. Vioxx generated $2.5 billion in sales last year.

23 Days

In the first case to go to trial, a Texas state court jury ordered Merck in August to pay $253 million to the family of a man who died after taking the drug for about eight months. The verdict likely will be reduced to about $25 million under Texas law.

Irvin, a 53-year-old manager of an Augustine, Florida-based seafood distributor, died in 2001 after taking Vioxx for 23 days for lower-back pain. Lawyers for his family contend the former college football player was in good health and that Vioxx caused his sudden heart attack.

Merck's lawyers counter Irvin's age, weight, clogged arteries and family history are to blame for his death. They also contend researchers only found a link between Vioxx and heart problems for people who used it for 18 months or more.

Topol, who authored a 2001 paper highlighting Vioxx users' heart attack risks, testified he began his study after finding ``discrepancies'' between Merck's Vioxx safety studies and the U.S. Food & Drug Administration's data.


After analyzing three Vioxx studies, Topol found patients began experiencing sharply higher rates of heart problems ``four to six weeks after the start of taking Vioxx.''

The 51-year-old Topol testified he and his colleagues urged Merck to study Vioxx's effects on heart patients. They submitted proposals to conduct such reviews, known as clinical trials, he added.

``Any trial would've been helpful, but no trial was done,'' the cardiologist testified. ``It has not been done to this day.''

Merck officials sought to convince Topol his Vioxx conclusions were wrong and even rewrote a paper he'd submitted for company review to ``neutralize'' the impact of his findings, the cardiologist testified.

In earlier Vioxx trials, plaintiffs' attorneys produced internal Merck e-mails showing company officials launched a campaign to neutralize or discredit Vioxx's critics. The e-mails haven't yet been introduced in the Houston case.

`Gotten It Wrong'

A team of Merck scientists traveled to the Cleveland Clinic in 2001 in an unsuccessful bid to persuade him not to publish his paper, Topol recalled.

Merck officials ``said we had gotten it wrong and we'd be embarrassed if we published it,'' the cardiologist recalled. ``The purpose of academic medicine is the highly objective, independent processing of data and any effort to warp that or twist it is unacceptable.''

Company officials even complained about Topol's research to a member of the Cleveland Clinic's board, the cardiologist said in his deposition. The facility has been ranked by U.S. News & World Report magazine as one of the U.S.'s four best hospitals.

Vioxx User

Former Merck Chairman and Chief Executive Officer Raymond Gilmartin called Malachi Mixon, head of the hospital's board, in October 2004 to question why Topol was targeting Vioxx, the cardiologist testified in his deposition.

Gilmartin questioned, ``What has Merck ever done to the Cleveland Clinic to warrant this?'' Topol said. The cardiologist added that he was ``appalled'' by Merck's tactics.

During cross-examination, Topol acknowledged he took Vioxx for knee pain starting in 1999 and continued to use it intermittently for several years.

Challenged by the company's lawyers on why he would take a drug he considered unsafe, Topol countered that he didn't fit the profile of someone facing an increased risk heart attack or stroke from the drug.

``I didn't think I was one of the people who should be worried,'' he said. The doctor noted he was 45 years old at the time with no history of heart disease.

U.S. District Judge Eldon Fallon, who is presiding over the Houston case, has said he expects it to wrap up next week. Fallon, based in New Orleans, moved the case to Houston after Hurricane Katrina sparked flooding that ravaged his home city.

The case is Plunkett vs. Merck & Co., 05-MD-1657, in the Eastern District of Louisiana.

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