It yanked Vioxx three years after the first studies raised safety alarms. That delay could hurt patients and shareholders alike.
On Sept 3. Newton Acker, 71, died of a stroke while on a bicycling vacation with his wife in southern France. His three grown children were stunned. Apart from his arthritis, Acker was exceptionally healthy.He had low cholesterol and low blood pressure and bicycled 5,000 miles a year. His parents had lived to age 90.
Four weeks later Merck & Co. pulled Vioxx from the market after a study showed it doubled the risk of heart attacks and stroke. “That’s the answer,”Acker’s son, Kenneth, an F-16 training pilot in Arizona, immediately thought. His dad had been taking Vioxx for 14 months before his death. Kenneth blames Merck for failing to act sooner and plans to sue. “We don’t need the money. We just want my father back,” he says.
Prominent doctors are calling for congressional investigations, and European regulators are scrutinizing the safety of similar drugs such as Pfizer’s Bextra and Celebrex.
Merck will be lucky to survive a legal onslaught that easily could rival the $13.3 billion in damages paid out so far by Wyeth in a far smaller drug recall, the fen-phen fiasco. “This may be the biggest drug safety catastrophe in U.S. history,” says Vanderbilt epidemiologist Wayne Ray, who published a study linking high doses of Vioxx to heart attacks in 2002. Until this month “there was a solid wall of denial” from Merck, he says. “We need to investigate why the [safety] signals were ignored.”
Wyeth’s diet pills, Redux (dexfenfluramine) and Pondimin (fenfluramine), were taken by 6 million Americans before getting yanked off the market in 1997 because of a link to heart-valve defects. Vioxx was swallowed by 20 million patients in the U.S. in five years on the market and by some estimates caused 30,000 heart attacks. Cleveland Clinic cardiologist Eric Topol says the number of injured parties could go as high as 160,000. Merck says such extrapolations are unreliable. “The potential liability is mind-boggling,” says drug industry analyst Hemant Shah. “Every person who took Vioxx and had a heart attack is a potential litigant.”
Merck Chief Executive Raymond Gilmartin says that none of Merck’s earlier Vioxx studies had found excess risk; as soon as that changed, the company quickly pulled the drug even though some of its own consultants advised against it. “This kind of behavior, considering only the interests of patients, should reconfirm people’s confidence in the drug industry,” he says.
But even before the recall more than 400 lawsuits had been filed on behalf of Vioxx patients, according to LexisNexis’ “Mealey’s Reports.” New York law firm Parker & Waichman was flooded with 3,000 calls and e-mails in the week following the Vioxx recall. Partner Jerrold Parker says at least 20% of the calls involve very serious injury or death. Christopher Seeger, a plaintiff’s lawyer in 75 Vioxx injury cases, says: “I’ve never had the phones ringing off the hook like this.”
From the moment it hit the market in 1999, Vioxx had one vital claim: It was a safer painkiller that didn’t cause ulcers as often as older drugs do. But just two years later cardiologists warned of a potential problem: Merck’s own 8,000-person study, the same one that showed Vioxx reduced ulcer complications, also found that patients on the drug had more than double the risk of heart problems of those on another painkiller, naproxen (the ingredient in over-the-counter Aleve). Merck dismissed the result, insisting that the discrepancy was due to an extra heart benefit from naproxen. (Merck still contends this is the case.)