12 décembre 2005 02:30

12.11.2005, 06:03 PM

Merck & Co.'s failure to disclose information about additional heart attacks in a Vioxx clinical trial to a prominent medical journal strengthens plaintiffs' cases because it bolsters claims that the company deliberately disguised the pain reliever's risks, experts said.

Last Thursday, the New England Journal of Medicine issued an editorial which said at least two authors of a Vioxx study called VIGOR knew at least two weeks before the paper was submitted and 4 1/2 months before it was published that there were three heart attacks not included in the article's data. The absence of the data led to incorrect calculations and conclusions, the editorial said.

Moreover, a spokeswoman for the Journal said Merck deleted a chart which included the additional heart attacks from the manuscript that was submitted.

"I think this is terribly damaging to Merck," said Howard Erichson, a professor at Seton Hall Law School. "The fact that a prominent medical journal is accusing Merck with hiding information about Vioxx goes straight to the heart of their defense that they did nothing wrong."

The revelations came out after the jury in the first federal trial going began deliberating. Jurors in Houston ended their third day of deliberations on Saturday without reaching a verdict after telling the judge earlier that day that they were deadlocked. Deliberations are set to resume Monday.

VIGOR was designed to see if Vioxx was gentler on the stomach than naproxen, an older pain reliever. The original Journal article was published in 2000 and said that Vioxx caused fewer gastrointestinal problems than naproxen. It also said patients taking Vioxx had four times the rate of heart attacks as patients taking naproxen. If the three additional heart attacks were included, the rate jumped to five times.

At the time, Merck explained the difference in the rate of heart attacks by saying that naproxen is cardioprotective.

Merck said in a statement on Thursday the additional heart attacks "did not materially change any of the conclusions of the article." Merck also said the information was not included because the heart attacks were reported after Merck's cut-off date for collecting information on the patients in the study.

The additional events were disclosed to the FDA in 2000, presented publicly at the FDA's Advisory Committee in February 2001 and included in numerous press releases, Merck said.

Merck removed Vioxx from the market last year after a study found it doubled patients risk of heart attack and strokes after 18 months of use.

The VIGOR study has figured prominently in the three Vioxx trials, including the Houston case where the jury is considering where the drug caused the fatal heart attack of a 53-year old man who was taking the pain reliever for about a month. Merck continues to say it believed naproxen was cardioprotective. Plaintiff lawyers have used the study to illustrate how Merck ignored a huge warning about Vioxx's risk and created a bogus explanation for the results.

Experts say the study may come to symbolize Merck's lack of credibility.

"This respected journal issuing a critique of Merck's behavior is especially important to a jury who now sees Merck as a company that doctors studies," said John Thomas, a health care law professor at Quinnipac University School of Law.

Plaintiff lawyers are itching to use the recent revelations in future trials. One of the article's authors is Merck's director of clinical research, Dr. Alise Reicin, who has defended the company's conduct at all three trials. Plaintiff lawyers can't wait for opportunity to ask her to explain the company's actions.

"I'm salivating at the notion," said Mark Lanier, who won the first Vioxx trial in Texas over the summer and is slated to try a case in New Jersey in February. Merck won the first New Jersey case.

Plaintiff lawyer Robert Gordon, who is trying the case with Lanier, said the new information discredits Merck's statements that they really believed there was nothing wrong with the job.

"It shows they weren't just deluding themselves but that they were lying," Gordon said.

He believes the new evidence is proof that Merck should have to pay punitive damages because it proves the company willfully deceived patients.