Merck Rushed Vioxx Development, Court Told

posted on:
March 7, 2006

author:
Staff

New Jersey – Merck & Co. Inc. accelerated development of its Vioxx pain drug because it calculated it could lose more than $600 million a year if it did not beat competitors to market, a court heard on Tuesday.

David Anstice, Merck’s former president of human health, told jurors in the latest Vioxx liability trial that Merck was concerned profits would fall if it did not compete effectively with Pfizer Inc.’s similar arthritis drug Celebrex.

“We were working very diligently and aggressively to get Vioxx to market as quickly as possible,” Anstice said in state court in Atlantic City under questioning from Mark Lanier, an attorney for a man who blames Vioxx for his 2003 heart attack.

In the second Vioxx case to be tried in New Jersey, two former long-term Vioxx users who claim the drug caused their heart attacks are suing Merck. The company is facing nearly 10,000 lawsuits related to the withdrawn pain drug.

Lanier, who last year won a $253 million award for the widow of a Texas man who took Vioxx, accused Merck of cutting corners in the development of the drug and seeking regulators’ approval in half the normal time.

Lanier quoted a May 1999 memo from Merck’s former top scientist, Ed Scolnick, saying Merck would be a “completely different company” if it could not make Vioxx a commercial success. The company needed Vioxx revenue to replace sales of six major drugs with patents soon to expire, Lanier argued.

Merck officials calculated that Vioxx was worth $889 million a year in sales if it reached the market first and $278 million if the drug followed Celebrex, the court heard.

Vioxx eventually reached about $2.5 billion in annual sales before Merck withdrew it in September 2004, after a study showed it doubled the risk of heart attack and stroke in patients who took it for at least 18 months.

The company placed so much faith in Vioxx’s commercial potential that it hired its biggest-ever sales force, spent $1 million on a lavish launch party, and gave away more free samples than for any previous product, Lanier told the court.

“I was trying to convey my excitement and enthusiasm for the project,” said Anstice, who headed sales and marketing for Merck at the time of the Vioxx launch.

Lanier accused Anstice and other Merck officials of “not telling the whole truth” about the heart risks of Vioxx because they needed to make it a commercial success.

The attorney cited a letter from the U.S. Food and Drug Administration attacking a May 2001 Merck press release touting the “favorable cardiovascular safety profile” of Vioxx. The FDA called the claim “false and misleading.”

Merck negotiated with the FDA to ensure that warnings about the heart risks of Vioxx were played down on the drug’s labeling, Lanier told the court.

A study of 8,000 patients published in 2000 showed Vioxx users were five times more likely to suffer heart attacks than those taking naproxen, another pain-killer. Merck has said it believed naproxen was heart protective rather than Vioxx being riskier in defending its decision to keep selling the drug.

“You were worried about the bad news getting into the label because it was going to cost you money, weren’t you?” Lanier asked Anstice.

Anstice rejected the suggestion that the Vioxx label deprived people of information they needed to avoid adding to their already heightened risk of a heart attack.

“The language still pointed people to the precautions,” Anstice said of the Vioxx label.

Anstice, who spent about six hours on the witness stand on Tuesday, dismissed a Lanier accusation that sales people had been encouraged to give incomplete and inaccurate information to physicians about the risks of prescribing Vioxx.

“Our reps were obliged to provide fair and balanced information consistent with the label,” Anstice insisted.

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