Witness blasts Merck's methods - firm went after those who questioned safety

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Sun, Dec. 04, 2005

Witness blasts Merck's methods

In a video played for a federal jury, a top cardiologist said the firm

went after those who questioned Vioxx's safety.

By Theresa Agovino

Associated Press

http://www.philly.com/mld/inquirer/news/nation/13324127.htm

HOUSTON - A prominent cardiologist testifying in Merck & Co.'s federal

trial over Vioxx accused the drugmaker of engaging in scientific

misconduct, suppressing clinical evidence, and stifling medical discourse

as it promoted the painkiller.

In a three-hour videotaped deposition played yesterday for the jury,

Topol, chairman of the cardiovascular-medicine department at the Cleveland

Clinic, called certain aspects of Merck's behavior " repulsive " and

" appalling. "

Topol said that Vioxx can cause heart attacks any time after a patient

begins taking it, and that its risks were apparent as early as 1999, when

the drug was approved. Vioxx was removed from the market last year after a

study showed it doubled patients' risk of heart attacks and strokes after

18 months of use.

" Vioxx's risk has been evident since trials were conducted in 1999, and

all the way through the time of withdrawal on Sept. 30, 2004, " Topol said.

This is the first federal trial over Vioxx; Merck has already lost one

state trial and won another, but it still faces about 7,000 lawsuits.

Analysts estimate Merck's liability could reach $50 billion.

Merck, the world's sixth-largest drugmaker and Pennsylvania's largest

manufacturer, last week announced the layoff of 7,000 employees, saying

legal bills in connection with Vioxx were partly to blame. The firm, based

in Whitehouse Station, N.J., has its largest complex in West Point,

Montgomery County.

The jurors who heard Topol's testimony yesterday will be asked to decide

whether the drug contributed to the fatal heart attack suffered by

" Dicky " Irvin in May 2001. The 53-year-old former manager of a seafood

wholesaler had been taking Vioxx for about a month for back pain. His

widow is suing Merck.

Merck: Vioxx not to blame

Merck argues that the drug was not responsible for Irvin's death, saying

that problems with Vioxx surface after about 18 months of use, not one

month, and alleging that plaque in Irvin's artery ruptured and caused the

heart attack, not the drug.

Topol said the concerns about Vioxx caught his eye after he read an

article about a study released by Merck in 2000 that found patients taking

Vioxx had five times the rate of heart attacks as those taking naproxen,

another pain reliever. In the article, Merck explained differences found

in that study by saying naproxen was cardioprotective. Topol said naproxen

wasn't associated with such properties.

" To all of a sudden ascribe some type of magical protective effect [to

naproxen] without any basis is not acceptable, " he said.

Discrepancies found

When he compared the U.S. Food and Drug Administration records of the

study with the data in the New England Journal of Medicine article, Topol

said, he found several discrepancies. In particular, he said, the numbers

of deaths and heart attacks were higher in the FDA data. He called the

discrepancies " scientific misconduct. "

Topol also said that the company had conducted a clinical trial in 1999

comparing Vioxx to a placebo and nabumetone, another pain reliever, that

found Vioxx caused a " 760 percent excess rate of heart attacks, " but that

the study was never published.

In 2001, as Topol was preparing to publish an article he had written

highlighting cardiovascular risk from Vioxx, he received a visit from

Alise Reicin, vice president of clinical research at Merck Research Labs.

According to Topol, Reicin told him he would be " embarrassed " if he

published the article because he didn't have all the data. Topol learned

during his deposition that Reicin had told a colleague she was hoping to

get the article toned down, a move Topol found " appalling. "

After the article was published, Topol said, Merck sent letters to doctors

all over the country saying his analysis was wrong.

Under cross-examination, Topol conceded in his article he wrote that

results in the unpublished study were statistically insignificant, but he

said he didn't have all the data at the time.

Topol also testified that Merck's former chairman, Gilmartin, had

approached the chairman of the Cleveland Clinic to complain about his

frequent criticism of Vioxx. Topol referred to that action as " repulsive. "

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