http://www.mercola.com/2004/dec/18/vioxx.htm
Dr. David Graham, associate director in the FDA's
Office of Drug Safety,
called the FDA's approval of arthritis drug Vioxx,
"The single greatest
drug
safety catastrophe in the history of this country
or the history of this
world." Graham went on to cite the following
statistic: A staggering
88,000
to 139,000 Americans suffered heart attacks and
strokes as a result of
taking Vioxx.
In addition to Vioxx, Graham named five other
drugs that are putting the
lives of the public at risk. The five drugs in
question are:
* Meridia
* Crestor
* Accutane
* Serevent
* Bextra
Graham stated that the FDA's inability to protect
Americans from another
case similar to the Vioxx case was clear evidence
that massive changes
need
to be implemented for the future protection of the
public.
One of the regulatory changes Graham proposed was
granting the Office of
Drug Safety independent regulatory authority.
Presently, safety officers
are
faced with a conflict of interest in the event
they have to convince the
Office of New Drugs that a drug is causing side
effects. The conflict
arises
because the very group that approved the drug in
the first place is also
responsible for taking regulatory action against
any post-marketing
activities.
Graham's Future
Tom Devine, Graham's lawyer, stated that Graham
would be exiled from his
duties of reviewing drugs and placed in the office
of the commissioner.
Devine described this position as "filling space
under the scrutinizing
watch of a babysitter."
USA Today November 25, 2004
British Medical Journal November 27, 2004
Dr. Mercola's Comment:
Dr. David Graham is one of my new heroes. He is
the person who blew the
whistle on the FDA when he testified before
Congress about Vioxx late in
November.
So what does Dr. Graham get for blowing the
whistle?
He's going to be exiled from his work reviewing
drugs and put to work in
the
office of the commissioner. The irony here is
unmistakable. First, the FDA
is quietly let off the hook after approving a drug
responsible for causing
almost 139,000 deaths, and then the person who
speaks out against this is
stripped of his job responsibilities.
I look up to Dr. Graham not only for his honest
testimony and concern for
public safety, but for the integrity of his
character. His background
information includes father to six children,
assistant scoutmaster and a
wiry long-distance runner turned backpacker who,
when flummoxed, begins
sentences with an "Oh, golly." He is no slacker,
as he was educated at one
of the leading medical schools in the world, Johns
Hopkins University
School
of Medicine. He also attended Yale and the
University of Pennsylvania.
This is a man of conviction, and he will likely be
one of the single
leading
forces making a dent in this fatally flawed
paradigm. Perhaps I am biased
because he is a fellow runner, but I LOVE this guy
and hope I will be able
to meet him some day.
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