CREATION OF NEW DRUG 'REGULATORS' PROMPTED BY VIOXX VERDICT
In the wake of the Vioxx verdict, the pharmaceutical industry is facing a new set of regulators, according to the former chief counsel of the FDA.
But rather than roaming the halls of Rockville, these regulators occupy courthouses and statehouses across the country, said Daniel Troy, who left the agency in November 2004 for offices of his own at the law firm of Sidley Austin Brown.
These new de facto regulators are made up of plaintiffs' attorneys and juries, state attorneys general and U.S. attorneys, and the effect on the industry could be substantial, according to Troy.
The former FDA counsel pointed to the recent Vioxx (rofecoxib) verdict as an indication of what this shift could portend. While the $253 million in damages awarded to a widow by a Texas jury will probably be reduced to something more in the neighborhood of $26 million, the sheer volume of potential lawsuits could be fatal for the drugmaker, Troy said. Noting that estimates of the deaths for which Vioxx might be blamed range from 4,000 to as high as 140,000, Troy said, "Multiply that number ($26 million) times any of these, and you don't have Merck anymore."
The Vioxx verdict itself is reflective of what Troy contends is an exaggerated emphasis on drug safety in the wake of controversies over the past 18 months that include revelations about increased risk of suicide among children and adolescents taking some antidepressants, the shortage of flu vaccine, and the connection between other Cox-2 inhibitors like Bextra (valdecoxib) and Celebrex (celecoxib) and increased risk of cardiovascular events.
But the agency has overreacted to that criticism in its creation of a Drug Safety Oversight Board and the planned creation of a Drug Watch website to which it will post "early" information on the safety of marketed drugs, Troy said. "Transparency is not good if it leads to bad information," he said.