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Merck Executive Says Studies Showed Vioxx Was Safe for Humans

Posted on: Thursday, 20 October 2005, 21:00 CDT

By Thomas Ginsberg, The Philadelphia Inquirer

Oct. 21--ATLANTIC CITY -- In a day of combative questioning and objections by lawyers, a Merck & Co. Inc. scientist said yesterday that several studies on dogs and rabbits convinced him and his colleagues in the late 1990s that Vioxx was safe for the human heart.

But the testimony by Merck's soft-spoken executive vice president for clinical studies, Barry J. Gertz, came under relentless attack in cross-examination by a lawyer for an Idaho heart-attack patient trying to undermine Merck's claim that it thought Vioxx was safe.

"We're talking about bunnies, your honor," attorney Christopher Seeger said when objecting to Gertz's testimony about rabbit studies. Later turning to Gertz, Seeger said, "Veterinarians didn't prescribe Vioxx, did they? Bunnies didn't take Vioxx, did they?"

Seeger's comments drew smiles from some jurors but also an objection from Merck's legal team and a mild rebuke from Judge Carol E. Higbee, who told him to refrain from making commentary in front of the jury.

The exchanges between lawyers crescendoed through the day, until Seeger and one of Merck's lawyers, Stephen Raber, seemed to spend almost as much time objecting to each other's questions and bickering privately with the judge as eliciting answers from Gertz, leaving jurors to swirl in their chairs and chat with each other. At one point, Seeger snapped in response to Raber's rambling objection, "Let's swear in Steve," prompting more snickers from the jury.

Raber called Seeger "outrageous" at several points.

The case, now in its sixth week, was brought by Frederick "Mike" Humeston, a former Marine and two-time recipient of the Purple Heart, who contends that Vioxx caused his heart attack after just a few weeks of use and that Merck failed to warn physicians about its risks.

Merck says there is no clinical proof that Vioxx raises heart-attack risk before 18 months of use and that Humeston's personal risk factors, not Vioxx, led to his heart attack.

Merck faces at least 5,000 cases nationwide, half before Higbee in New Jersey, giving the case particular importance for the drugmaker, based in Whitehouse Station, N.J. It has filed at least five mistrial motions so far and submitted a new motion yesterday asking the judge to reverse her rule barring a 2005 document from the U.S. Food and Drug Administration finding Vioxx, on balance, safe to use.

Gertz said Merck conducted several studies in the late 1990s on rabbits and dogs, at its labs in Montreal, New Jersey and suburban Philadelphia, to address a concern raised by University of Pennsylvania scientist Garret FitzGerald that cox-2 inhibitors drugs like Vioxx could cause an imbalance in enzymes and lead to cardiovascular problems.

"We concluded that cox-2 is not playing any role" in the imbalance, Gertz said.

On cross-examination, Seeger sought to undermine Gertz's credibility by suggesting his job was to prevent or water-down any scientific criticism of Merck products. Seeger cited one Merck-sponsored study authored in part by a Merck epidemiologist, Carolyn Cannuscio, whose name Merck insisted on removing before publication because the study concluded Vioxx could be risky.

"We did not take her off because we did not like the results," Gertz shot back. "The study misinterpreted the data and did not include all the data."

Asked later about the study by Raber, Gertz pointed out that Merck never tried to stop publication of the article itself but still disputes its conclusions.

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Copyright (c) 2005, The Philadelphia Inquirer

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MRK,

Source: The Philadelphia Inquirer

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