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 in court few days before in a Vioxx product liability trial.
But Edward Scolnick, president of Merck Research Laboratories until he retired in 2002, also was upset about pressure from the Food and Drug Administration to put safety warnings on the blockbuster arthritis drug.
Scolnick testified April 29 via videotape, excerpts of which were played in court for the jury hearing the case of an Idaho postal worker suing Whitehouse Station-based Merck.
Humeston attorney Chris Seeger said the FDA, which had concerns about the safety of Vioxx over data Merck gave the agency after the drug was on the market, pressed to add a warning about its potential risks to the product label, the detailed insert that comes with prescriptions.
Moreover, in this trial a heart expert told jurors that Vioxx manufacturer Merck & Co ignored evidence the painkiller posed safety risks before it hit the market in 1999. Dr Benedict Lucchesi, who was testifying on Friday on behalf of a man who blames Vioxx for his heart attack, was shown a series of internal Merck e-mails. Lucchesi, an expert on the heart and the effects of medications, appeared to fight back tears after the plaintiff’s attorney Chris Seeger referred to a 1997 message sent by Merck researcher Briggs Morrison to fellow company scientists.
In it, Morrison - discussing the proposed design of an upcoming clinical trial of the drug - advocated letting the patients in the study take aspirin at the same time as Vioxx.
Without aspirin’s blood-thinning effects, he wrote, “you will get more (dangerous blood clots) and kill drug.” Lucchesi interpreted the statement to mean Merck feared that without aspirin to offset Vioxx’s cardiac risk, those participating in the trial would be in greater danger and that would spell trouble for Merck as it pushed to debut Vioxx.
“When I first read that, I personally became enraged,” said Lucchesi, 72, a professor at the University of Michigan who helped develop the first pacemaker. Apart from this, other 150 people in Puerto Rico is going to file lawsuits against the maker of withdrawn painkiller Vioxx, an attorney said Tuesday.
The plaintiffs will file their cases against Merck & Co. District Court on Wednesday and ask for class-action status, said Archie Lamb, an attorney working with Consejo de Latinos Unidos (Council of United Latinos), a consumer advocacy group advising former Vioxx users in the island.
The plaintiffs include relatives of 18 people who died, allegedly from heart complications related to Vioxx use, Lamb said. 30, 2004, after a study found it doubled patients’ risks of heart attacks and strokes after 18 months. But the new labels were published in English in Puerto Rico, even though Spanish is the most common language spoken on the island, according a March report by Consejo de Latinos Unidos.