And now the rest of the story from web MD:

Naproxen Warning Unjustified, Say FDA Experts

Report Linking Aleve to Heart Attacks Unnecessarily Scared Public

By Todd Zwillich
WebMD Medical News  Reviewed By Michael Smith, MD
on Friday, February 18, 2005  

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Feb. 18, 2005 - A report last year that linked the pain killer
naproxen to heart attacks unnecessarily scared the public, experts
charged Friday.

FDA advisory panel members reviewing the safety of the arthritis drug
Vioxx and similar drugs accused National Institutes of Health
officials of acting irresponsibly when they stopped a study testing
the drugs Celebrex and naproxen in preventing Alzheimer's
disease.Celebrex and naproxen in preventing Alzheimer's disease.
Naproxen is sold under many brand names, including Aleve and Naprosyn.

The NIH halted the trial, called ADAPT, after data suggested that
naproxen raised the risk of heart attack and stroke in study patients.

An earlier study showed that Celebrex had similar risks.

NIH Director Elias A. Zerhouni, MD, released a statement saying that
the trial was being stopped "as a precautionary measure to ensure the
safety of the study's participants" and that the researchers made
their decision based on the risk/benefit analysis specific to this
trial.

But one ADAPT researcher told the panel Friday that naproxen's effect
on heart risk was "barely significant" and that the study was not
stopped because of safety concerns. Instead, officials halted the
trial because of a concern that questions on the safety of VioxxVioxx
and related drugs would make study participants reluctant to take
their medications and damage the integrity of the study.

"There seemed little practical choice but to do so," said Constantine
Lyketsos, MD, a Johns Hopkins University researcher who was part of
the ADAPT study team. Some study patients had already begun to resist
taking their drugs, and study directors became fearful that patients
would "vote with their feet" and stop participating altogether.

"We feared further erosion" of the study, he said.

Lyketsos also said that study leaders faced an ethical dilemma of
continuing with an Alzheimer's prevention study with no expected
immediate benefit to patients, given possible safety concerns with
Celebrex, Vioxx, and similar drugs, called Cox-2 inhibitors.

FDA experts harshly criticized the NIH's announcement, saying that it
potentially scared millions of naproxen patients despite some pervious
data suggesting that the drug may actually be safer for the heart than
Cox-2 drugs.

Studies have suggested that naproxen may carry a lower heart risk than
Cox-2 drugs, but researchers remain unsure of its heart safety since
it has never been tested against a placebo.

The announcement "had the effect that was the equivalent of screaming
'fire' in a crowded auditorium," said Steven Nissen, MD, a panel
member and medical director of The Cleveland Clinic.

Nissen said he and other cardiologists were forced to field calls from
hundreds of frightened patients who had read media reports of
naproxen's dangers.

"It caused a panic that was unnecessary, and it shouldn't have
happened, and I hope it doesn't happen again," said Nissen. "We can't
do business this way."

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