WASHINGTON – Merck & Co. (MRK) is holding discussions with federal health officials about bringing its painkiller Vioxx (search) back to the market, officials revealed Thursday, as lawmakers released new details of the extraordinary measures the company's salespeople took to divert doctors' attention away from safety questions.
Merck (search) employed 3,000 salespeople who eventually turned the painkiller into a multibillion-dollar blockbuster. They used projects code-named "Offense" and "XXceleration" to try to convince doctors the drug was safe even as troubling heart risks were coming to light, according to documents released by Rep. Henry Waxman (search), D-Calif.
"Do not initiate discussions" on those risks, one memo to salespeople said on Feb. 9, 2001. Another document describes "obstacle handling" in how to overcome physician concerns.
"When it comes to the one thing doctors most needed to know about Vioxx — it's health risks — Merck's answer seems to be disinformation and censorship," Waxman said at a House Government Reform Committee hearing.
He said that when doctors asked about potential heart risks that were making headlines at the time, salespeople handed them cards that instead provided different data suggesting Vioxx was safer than older painkillers.
Merck vice president Dennis Erb defended the company's handling of Vioxx, noting that it promptly released details of studies that first raised the specter of heart damage — and followed up by performing the study that ultimately doomed the drug.
"We believed wholeheartedly in the safety of Vioxx and that Vioxx was an important treatment option," he said. "My own father was a regular user of Vioxx until we voluntarily withdrew it from the market."
Erb also indicated the company is talking to the Food and Drug Administration about making Vioxx available to consumers again.
Merck pulled Vioxx off the market last fall after a study showed it doubled the risk of heart attacks and strokes in patients using the drug for more than 18 months. Merck now is facing more than 2,300 lawsuits from customers alleging Vioxx harmed them, and on Thursday its chief executive stepped down over the debacle.