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Painkillers' Ill Health

FDA hearings on drugs such as Vioxx, Celebrex and Bextra start tomorrow, but many doctors and patients have already halted use

Feb 15, 2005 | Philadelphia Inquirer The federal government will begin hearings tomorrow to determine the fate of some of the most popular painkillers of all time, but many doctors and patients are already turning away from the drugs.

Amid mounting reports questioning the safety of arthritis painkillers known as Cox-2 inhibitors, new figures show that doctors have moved sharply away from prescribing Celebrex and Bextra, the two remaining Cox-2s after the withdrawal of Vioxx in September.

New prescriptions written by primary-care doctors for both drugs have plummeted, even though their maker, Pfizer Inc., defends their safety and efficacy.

Celebrex accounted for just 5 percent of all new prescriptions in its category of painkillers last week down from 18 percent in early October, according to ImpactRx Inc., a Mount Laurel firm that tracks the daily prescribing practices of doctors. Bextra prescriptions dropped from 16 percent to 3 percent as doctors moved toward older drugs, such as ibuprofen.

"This is a huge decline," said Nancy Lurker, ImpactRx's chief executive officer. New prescriptions are a predictor of a drug's future use, she said.

The troubles facing Cox-2 drugs show what can happen when drugs are approved by the Food and Drug Administration and become blockbusters before their health downsides are fully understood. Already, millions of people were taking the Cox-2 drugs for nonlethal pain when research began showing that they could cause deadly heart attacks and strokes.

Garret FitzGerald, a University of Pennsylvania researcher, called it a "tragedy of blockbuster overreach." Painkillers that could help some patients became overused, he said.

The Cox-2 controversy has left doctors, patients and the public in "an acute confusional state," wrote Eric Topol, a researcher at the Cleveland Clinic Foundation. Some are abandoning the pills, others fear they have been harmed and are lining up to sue, while still others continue to take their pills warily.

Elaine Stern, 48, a nurse from Narberth, has replaced Bextra with ibuprofen, though it does not work as well for the arthritis in her feet. "I'm living with the discomfort and waiting for the dust to settle," she said.

The controversy over Cox-2 drugs has far wider consequences tarnishing the reputation of FDA regulators whom critics blame for failing to act on safety concerns. The agency must decide whether Cox-2s either specific ones or the entire class should be restricted or marketed at all.

David J. Graham, an FDA official who blasted the agency in congressional testimony, estimated that Vioxx had caused 88,000 to 139,000 cases of serious heart disease in the United States - as many as 40 percent of them fatal - since the drug was introduced in 1999.

Many former users now think they are victims. "I feel like I was prescribed something that could have killed me," said John Bohrer, 46, a pastry chef from Northeast Philadelphia. He was taking Vioxx for back pain and suffered a heart attack in November 2003.

Bohrer has hired a lawyer to sue Merck & Co. Inc., which withdrew Vioxx after a company-funded study showed a doubling of heart-disease risk.

Paul Dolhancryk, a 55-year-old plumber from Delaware County, stopped taking Celebrex for his arthritic knees after he heard on TV that the drugs might be dangerous.

"I can't go on living life this," said Dolhancryk, who works at Bryn Mawr College. "I can't go up steps. I can't carry my daughter."

He is booked for double knee replacement in April, something he had hoped to put off for years by using Celebrex.

His doctor, Pennsylvania Hospital orthopedic surgeon Jess Lonner, said he was hearing from other patients who, without their Cox-2 drugs, could no longer tolerate their arthritic knees. Still, Lonner has stopped prescribing the drugs until more is known.

Advisory panels' options

At the three-day hearing starting tomorrow, two combined FDA advisory panels made up of 20 arthritis and drug-risk experts will review the evidence on Cox-2s and older drugs, such as naproxen.

Interviews with several members and a dozen outside experts indicate that the panels may avoid the most extreme recommendation - calling for Cox-2 drugs to be banned. The panels might instead recommend new warning labels, including the most serious "black box" warnings, or restrictions on marketing.

One option would be to place the drugs under a "restricted distribution" system, which would require patients to provide pharmacists with a heart health history.

"I will suggest that the Cox-2 drugs should be put into this class of drugs," said Henri R. Manasse Jr., a panel member and chief executive officer of the American Society of Health-System Pharmacists.

Panel member Arthur A. Levin, director of the nonpartisan Center for Medical Consumers, said the experts likely would agree that the drugs were risky but might diverge on what to do about it.

The FDA is not required to follow the panels' recommendations. But acting Commissioner Lester Crawford has already expressed "great concerns" about Celebrex and Bextra and said he would consider new warnings or a ban.

Pfizer plans to stand by the safety of Celebrex and Bextra and has submitted data supporting that view, spokeswoman Mariann Caprino said.

Medical needs

The Cox-2 drugs were developed to prevent a potentially fatal side effect of older drugs: gastrointestinal bleeding. "There was a tremendous medical need driving this," said Bob Raffa, a researcher at Temple University's School of Pharmacy.

Pushed by marketing that touted a painfree, happy lifestyle, Cox-2 sales more than tripled in five years.

Drug companies have never said the drugs work any better at reducing pain than traditional and cheaper drugs, such as ibuprofen. And only two, Vioxx and Prexige, the latter sold only overseas, reduce bleeding, said Topol, a Cox-2 expert.

Cox-2 drugs are "a triumph of marketing... testament to the fact that you can persuade people to spend more money for almost anything if you market it right," said Marcia Angell, former editor of the New England Journal of Medicine.

Some researchers believe Cox-2 drugs increase the risk of heart disease because they reduce prostacyclin, a heart-protecting fat. With less prostacyclin to protect arteries, people may become more prone to high blood pressure, heart attack and stroke, said Penn's FitzGerald, who in 1998 raised concerns about the drugs' downsides.

FitzGerald believes there is still a place for the drugs in a smaller pool of patients.

"I think the challenge here is to conserve the benefit, manage the risk," he said. "I think it would be a real mistake to withdraw the class."

It was the withdrawal of blockbuster Vioxx that put the spotlight on the FDA, accused by critics of reacting timidly to heart-disease concerns.

In 2000, the FDA had results of a Merck study showing a fourfold increase in heart attacks among Vioxx users compared with naproxen users. FDA officials responded with a warning letter to Merck about its promotional campaign. It took until 2002 for the agency to require new language in Vioxx packaging about risks for heart patients.

The agency, which had no comment yesterday, never required drug companies to study how Cox-2 drugs affect the heart, despite growing concerns.

The fact that no studies were done is "unbelievable. It's unconscionable," the Cleveland Clinic's Topol said. The FDA "knew when these drugs got out they would be used by heart-disease patients."

By one estimate, half the people who use Cox-2 drugs for arthritis also have heart disease. And in the Merck study that led to Vioxx's removal, the strokes and heart attacks emerged even though most study subjects had no history of heart disease.

No matter the outcome of the FDA hearings, Cox-2 drugs could face a difficult future.

Already one major insurer, Kaiser Permanente, dropped Bextra from its list of approved drugs. Two other Cox-2 drugs Merck's Arcoxia and a GlaxoSmithKline drug called 381 are in development and could face a lot more FDA scrutiny.

It may be hard for the Cox-2s to win back patients and doctors, said Lurker, of ImpactRx.

"Perceptions have been formed, and it's going to be tough to change those perceptions," she said.

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