Thanks to Gina for sending the following article...Myrl
Makers of embattled arthritis drugs need clear statements from experts
during upcoming FDA meeting
Much is riding on the outcome of a planned Feb. 16 Food and Drug
Administration meeting over the troubled drugs Celebrex, Vioxx, and
Bextra. The makers of the arthritis painkillers need regulators to make
a clear statement, good or bad, about the pills. Any vagueness about
the drugs accused of causing many heart attacks, will lead to many more
months of legal and public relations battles for the companies, some
pundits say. To learn more on this topic, be sure to also read the
related article, Arthritis creams merely mask symptoms and offer no
long-term relief, study shows.
http://www.newstarget.com/004581.html
- Staff writers
News summary:
Source:
http://www.forbes.com/technology/sciences/2005/02/07/cx_mh_0207fda.html
A panel of academic scientists--who have not yet been publicly
named--will meet to advise the U.S. Food and Drug Administration on the
safety of Cox-2 inhibitors such as Celebrex, Bextra and the withdrawn
Vioxx.
They will also delve into the safety of older anti-inflammatory
medicines such as Aleve and Motrin.
The task is so difficult that the FDA has allotted three days for the
work, a clear sign of controversy.
The last similar meeting was on the safety of breast implants.
The three-day discussion will provide a climax to a debate about drug
safety that began when Vioxx was pulled from the market for doubling
the risk of heart attacks and strokes at high doses over long-term use.
It will be an especially im****tant meeting for Pfizer (nyse: PFE - news
- people), which makes Celebrex and Bextra.
Even if Celebrex and Bextra don't make it through the meeting, Pfizer
could look like a winner to investors as long as it doesn't face a
massive liability cloud like the ever-ballooning diet-drug litigation
that has weighed on smaller rival Wyeth (nyse: WYE - news - people) for
years.
Here's a worst-case scenario: The data are analyzed by the FDA's
standing arthritis advisory committee, composed of well-intentioned
doctors who desperately need painkillers to give their patients.
University of Pennsylvania pharmacologist Garret FitzGerald has argued
that all the Cox-2 drugs make blood more likely to clot, thereby
increasing the risk of heart attack and stroke.
Even harder for the agency: The panel must contain people who saw the
Vioxx risk early on, and it must also contain researchers who have been
critical of the FDA's handling of the matter.
It is the presence of such critics that will make the panel's judgments
stick in the minds of the skeptical.
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