Merck Scientist Testifies on Concerns About Vioxx Safety, Pressure from FDA

By | September 23, 2005

A former chief scientist of Merck & Co. had concerns about the cardiovascular safety of painkiller Vioxx years before the company pulled it off the market, according to a videotaped deposition played during a Vioxx product liability trial continuing in a New Jersey court.

But Edward Scolnick, president of Merck Research Laboratories until 2002, also was upset about Food and Drug Administration pressure to put safety warnings on the blockbuster arthritis drug.

Scolnick testified April 29 via videotape, excerpts of which were played last week for the jury hearing the case of an Idaho postal worker suing Whitehouse Station-based Merck. Frederick “Mike” Humeston, 60, of Boise blames the popular arthritis drug for his 2001 heart attack.

Humeston attorney Chris Seeger said the FDA, amid safety concerns over data Merck submitted after Vioxx was on the market, pressed to add a warning about its potential risks to the product label, the detailed insert that comes with prescriptions.

Fearful the warning would hurt sales, Merck fought the FDA, according to internal e-mails shown to jurors in which Scolnick blasted regulators as “bastards.”

“You were FANTASTIC,” he wrote to his Vioxx development team in a Feb. 8, 2001 e-mail, after a Merck presentation to an FDA advisory committee. “You made them look like grade D high school students.”

When a colleague called the proposed warning “ugly” in an e-mail, Scolnick responded: “It is ugly cubed. They are bastards.”

Asked about the e-mail by David Buchanan, one of Humeston’s attorneys, Scolnick said he regretted the words but that they reflected his frustration with the FDA.

Ultimately, the warning was included on packaging, but under “precautions” instead of the more-serious “warnings” section.

Scolnick also testified about an April 2000 e-mail to a Merck colleague in which he said he was in “minor agony” about his fears that Vioxx was causing heart attacks, strokes and other problems. Scolnick recommended Merck do a study of the drug’s cardiovascular safety by having 10,000 patients take Vioxx and another 10,000 take Tylenol.

“We will not know for sure what is going on until we do this study. Please think hard about this,” Scolnick wrote.

Under questioning by Buchanan, Scolnick said his Vioxx development team said that could not be done because it would be unsafe to keep arthritis patients on Tylenol for so long. Long-term Tylenol use can damage the kidneys.

Scolnick also testified that Merck was under pressure in the late 1990s to replace key drugs coming off patent to prevent a revenue drop. Merck rival Pfizer Inc. was developing a similar painkiller and Merck wanted Vioxx to hit the market first. Pfizer’s Celebrex went on sale at the end of 1998, Vioxx in May 1999.

When Merck marketing executive David Anstice took the stand, he fielded questions about Vioxx marketing, which Humeston’s lawyers say took precedence over safety issues.

Knowing Vioxx would be a blockbuster, Merck compressed and accelerated clinical trials and asked FDA to speed up its approval process, Anstice said. But he insisted Merck didn’t cut corners.

Anstice said Merck spent at least $100 million a year on consumer ads for Vioxx. The drug’s success with patients who had stomach pain or bleeding from other pain relievers, but not while on Vioxx, helped it reach peak annual sales of $2.5 billion.

“Do you think it’s a good swap, upset stomachs versus heart attacks?” Seeger asked him.

Anstice said the data Merck had then didn’t support that characterization.

Merck pulled Vioxx off the market last September after research linked it to higher incidences of heart attacks and strokes after 18 months’ use, although a witness testified Monday that even a day’s use could trigger a heart attack in some patients.

Merck faces more than 5,000 lawsuits filed in state and federal courts by former Vioxx users alleging the medicine harmed them.

The first trial ended last month when a Texas jury stunned Merck with a $253 million liability verdict. It will be reduced to about $26 million because Texas caps punitive damages. Merck plans to appeal.

Copyright 2005 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Topics Drugs

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