Fearing a warning about Vioxx’s cardiac risks would hurt the painkiller’s sales, Merck & Co. battled with federal regulators for two years to keep the information out of the “warnings” section of the package insert, the company’s top marketing official testified Monday.
Under questioning by plaintiff’s attorney Chris Seeger, David W. Anstice acknowledged Merck forecast a $500 million drop in sales for the $2.5 billion-a-year blockbuster drug if Merck lost its bid to instead put information about heart attack risks in the insert’s less-urgent “precautions” section.
It was during those negotiations between Merck and the U.S. Food and Drug Administration that Frederick “Mike” Humeston suffered a heart attack, two months after he began taking Vioxx, said Seeger.
Merck prevailed on the label issue, but withdrew the drug from the market last September.
Humeston, 60, a postal worker in Boise, Idaho, is suing Merck in the second product liability trial over Vioxx, which he blames for his Sept. 18, 2001, heart attack. Merck, which is facing 5,000 such lawsuits, says the painkiller wasn’t to blame.
Anstice, who headed Merck’s business division during Vioxx’s development and sale, spent a third day on the witness stand Monday. Humeston’s lawyers have been grilling him about Merck’s marketing and promotion of Vioxx amid signs it could cause heart attacks and strokes in some users.
A patient study in 2000 showed Vioxx users suffered five times as many heart attacks as those taking the older, cheaper painkiller naproxen. Anstice testified that Merck asked the FDA to put that risk information in the “clinical studies” and “precautions” sections of the detailed package insert, or label, not in the more-serious “warnings” section.
In the meantime, Merck stuck to its policy of not letting its sales representatives talk to physicians about any potential risks not yet listed on the Vioxx label, Anstice said.
Seeger said if Merck was concerned about the safety of Vioxx users, salespeople could have been told to discuss the study.
Seeger again showed jurors e-mail messages written by Edward Scolnick, Merck’s former head research scientist, in which Scolnick ripped the FDA’s proposed label as “ugly” and called FDA officials “bastards.”
Scolnick, who testified earlier in the trial that he had lingering fears about Vioxx’s safety, told Merck colleagues in a Feb. 25, 2002, e-mail it would be a miracle if FDA agreed to put the warning in the “precautions” section.
“To all: If you get this label, it will be an Al Michaels quote: Do you believe in miracles?” Scolnick wrote, alluding to the sportscaster’s call when the U.S. hockey team defeated the Soviet Union in the 1980 Olympics.
On cross-examination by a Merck attorney, Anstice said it was Merck that proposed a new label adding the data about cardiovascular risks, twice asking the FDA for accelerated six-month reviews instead of the standard yearlong review, to no avail.
“We wanted to include the data from the VIGOR study on the Vioxx label,” Anstice told Merck lawyer Stephen Raber.
The VIGOR study, released in 2000, was the first public warning of problems with Vioxx.
The FDA finally OK’d the new label in April 2002, when it added approval to market Vioxx as “safe and effective” for rheumatoid arthritis, in which the immune system attacks the joints. It already was approved for the more common osteoarthritis and for general pain in adults. In 2004, the FDA added approval for use on migraine headaches and for children as young as 2 with juvenile rheumatoid arthritis.
On Tuesday, Humeston’s attorneys plan to show more videotaped testimony by Scolnick, after which Humeston’s son will testify about his father’s quality of life after the heart attack.
A cardiologist and Humeston himself also are expected to testify before the plaintiff’s attorneys wrap up their case this week. Merck will then begin presenting its case to the seven-woman, three-man jury.
The trial comes after a Texas jury awarded $253 million to the widow of a Vioxx user. That amount will be slashed because of Texas law limiting punitive damages.