One by one, arthritis drugs that promised to ease pain without causing ulcers are losing their luster.
In September, Merck & Co. yanked Vioxx from the market when a trial showed that long-term use of the painkiller nearly doubled the risk of heart attack and stroke. A congressional hearing next Thursday will examine whether Merck and the government ignored safety concerns.
This week, researchers said a preliminary study indicated that Bextra another painkiller in the same class also more than doubled the risk of heart attacks and strokes among patients with heart disease.
Pfizer Inc., which manufactures Bextra, said researchers made “unsubstantiated conclusions” during their presentation at the annual meeting of the American Heart Association in New Orleans. The company also said the research was “based on information that has not been published in a medical journal or subject to independent scientific review.”
The news sent a ripple through the meeting and caused the company’s stock to tumble.
Pfizer already has told regulators it will add to its packaging a black-box warning, the most strident alert, to warn consumers of a potentially fatal skin reaction linked to Bextra.
Scientists renewed a call for more studies of the painkillers in patients with heart disease, the group likely to suffer the most harm from this class of drugs known as cox-2 inhibitors.
“Arthritis drugs are not saving people’s lives. Ironically, they’re inducing heart attacks and may be losing people’s lives,” said Eric J. Topol, a Cleveland Clinic cardiologist who was among the first to warn about heart woes associated with the new painkillers.
The FDA controls drug marketing directed at consumers, Topol said. “The reality is they could shut that down at any time.”
Kathleen Quinn, an FDA spokeswoman, said the agency does not discuss negotiations or talks with companies. “We will be taking a look at the whole class of drugs.”
What’s a bone-weary consumer to do between now and then?
Experts give differing advice.
John Talley, the chemist who invented the Celebrex and Bextra molecules, said the cox-2 drugs helped people who could not tolerate the older generation of painkillers. “I do think these drugs have been a tremendous benefit to folks,” Talley said. “And they’ve been extensively studied.”
Consumers and doctors agreed, to the tune of 40 million cox-2 inhibitor prescriptions written in the first nine months of 2004, according to IMS Health, a company that tracks drug-industry trends.
Whether there is a classwide problem with cox-2 inhibitors, to many, remains debatable.
“I would hate for people to go off these medications on what may turn out to be unfounded rumors,” said Elizabeth A. Tindall, incoming president of the American College of Rheumatology. “Each drug has to be carefully scrutinized. I don’t think they’ve quite done that with Bextra to the extent they did with Vioxx.”
Clinicians who are the decision-makers at Kaiser Permanente, however, are alarmed by the Bextra findings and agree that there are safer alternatives.
“These drugs are no better for control of pain than Motrin,” said David Campen, Kaiser’s medical director of pharmacy operations. And most people do not enjoy the expensive drug’s slight benefit because they are not at risk for stomach ulcers, Campen said.
Topol, of the Cleveland Clinic, said naproxen should be the first anti-inflammatory of choice for people with arthritis who have heart problems.