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26 janvier, 2007 13:27
Drug Controversies Creating a Dilemma for Patients
HACKENSACK, N.J. - A rheumatologist is constantly on the phone trying to calm his patients. A doctor discovers his patients simply stopped taking their painkillers. And a retired welder wonders whether he will once again have to switch drugs to treat his arthritis.
The confusion that began three months ago when Vioxx was withdrawn from the market intensified over the past weeks with the halting of studies involving two other widely used painkillers - Celebrex and Aleve. Federal regulators said the drugs showed an increased risk of heart problems.
And most recently, the U.S. Food and Drug Administration, in an attempt to clarify the recent data, recommended "limited" use of Celebrex and Bextra, another drug that recently showed increased heart risks. Both are in the same class as Vioxx, which was withdrawn after a clinical trial found it was linked to higher risk of heart attack and stroke.
Several physicians said that they were aware of the risks of Celebrex and Aleve long before the FDA advisory and do not intend to alter treatment plans for most patients. But the doctors worry about patients overreacting to the flurry of news.
"I've had an onslaught of phone calls from worried patients," said Dr. David Arbit, a rheumatologist at The Valley Hospital in Ridgewood, N.J., who treats about 120 patients a week. "Patients are confused and they don't know what to believe anymore."
Dr. Ralph E. Marcus said several patients - without even consulting him - stopped taking Celebrex and Aleve when they read the news accounts of potential cardiac risk associated with the medications. Marcus, chief of rheumatology at Holy Name Hospital in Teaneck, N.J., said he advised patients to resume treatment.
"I've told them based on one study I would not stop taking the medication," he said.
John Jenkins, director of the FDA's office of new drugs, said last week that the agency has not made a final determination about possible regulatory action regarding Celebrex and Bextra. The agency called the advisory an "interim measure," pending further review of the data, and promised to hold a public meeting on the issue in February.
The FDA also advised consumers who use over-the-counter pain medications such as Aleve or ibuprofen, to strictly follow the label instructions, and to contact to their doctors if taking the drugs for more than 10 days. Naproxen, the generic name for Aleve, has been available for 28 years, the last 10 as a nonprescription product.
Health-care analyst Steve Findlay acknowledged recent data presents a confusing situation for consumers, but said they should not be alarmed.
"At this point, everyone needs to take a deep breath and wait to see what the regulatory authorities and the FDA and the companies do once they assess this evidence more fully," Findlay said.
For critics of the FDA, the confusion and controversy generated this week reinforces why there's "a sustained crisis in faith in both the pharmaceutical industry and in the regulatory system," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.
On Dec. 17, the National Institutes of Health announced it halted use of Celebrex in a colorectal cancer trial which showed the drug more than doubled the risk of heart problems
Patients in the study taking 800 milligrams of Celebrex a day had a 3.4 times greater risk of heart problems than those taking placebos. For those taking 400 mg, the risk was 2.5 times greater. To confound matters, another ongoing study of Celebrex at 400 mg a day did not show an increased risk. Patients in both studies were taking much higher doses than typically prescribed for osteoarthritis pain. The usual dose is 200 mg a day.
Calling the negative findings out of step with previous data, Pfizer Inc., Celebrex's maker, has not pulled the drug from the market, although it stopped its consumer advertising for Celebrex at the FDA's request.
Recently the NIH announced it suspended another study, this one examining prevention of Alzheimer's disease with Celebrex or Aleve. That trial involved about 2,400 volunteers who were randomly assigned either one of those two drugs or a placebo. The study followed people 70 and older for nearly three years who were considered to be at higher risk of developing Alzheimer's disease.
Dr. Susan Molchan, director of the Alzheimer's disease clinical trial program at the National Institute on Aging, said preliminary data showed about a 50 percent increase of heart attack and stroke in a small number of patients taking Aleve. This would not have ordinarily been grounds for halting the study, she said, but with patients dropping out after the Vioxx withdrawal and heightened concerns about Celebrex, it made sense, she said.
Meanwhile, patients and physicians were left to sort out the information.
Frank Dudlo, a 60-year-old patient, had a checkup last week in Arbit's Fair Lawn office. The doctor had recently switched the Clifton, N.J., man's prescription to Celebrex from Vioxx.
Dudlo, a retired welder who suffers from rheumatoid arthritis, called as soon as he heard news accounts of the study that questioned the safety of Celebrex. However, Arbit assured him the drug is safe and Dudlo isn't about to give up a medicine that relieves the stiffness and severe pain of his arthritis.
Dr. Gilbert Kepecs, chief of rheumatology at Hackensack University Medical Center, said he was still prescribing Celebrex and recommending Aleve despite the new data.
"I don't think that the recent data has changed anything about the medications," Kepecs said. "This is calling to light something physicians have known for a long time, that these drugs have certain risks. They've always had to be used cautiously."
The controversy of the past week, particularly about Celebrex, has fueled critics pushing for reform at the FDA. Sen. Charles Grassley, an Iowa Republican and chairman of the Senate Finance Committee, linked Celebrex with other drug controversies of the past year, including the use of antidepressants in children and the flu vaccine shortage.
"Right now we have a situation where the public is left wondering when the next shoe might drop when it comes to drug safety," Grassley said.
An Associated Press/Ipsos poll released last week found that 83 percent of Americans are at least "somewhat confident" in the safety of prescription drugs.
But some are still unsettled by the recent news.
"I have concerns that the FDA isn't doing their job," said Teaneck retiree Lou Schwartz. "They should have discovered this a long time ago. There's a rush to help the drug companies get these blockbusters to market at the expense of the rest of us."
Source: Charleston Gazette, The