I recently had a post published on Pro-Med that started out as a private
post to someone at Cal Poly. He sent it to the moderator and then privately
asked me to do some follow-up work on my end. I had to politely tell him
that this was impossible since I was "persona non grata" and virtually
disenfranchised here in Illinois. I sent him all the current documentation
I have about a certain very high ranking university official. A state
regulatory agency reviewed the documentation and told me it was outside of
their jurisdiction and to take it to law enforcement for charges of
conspiracy and fraud. His particular area of expertise is toxins and in
DOZENS of papers (this is unrelated to the fraud and conspiracy issue) he
and his band of colleagues recommend "safe" levels of toxins in spite of
histological evidence of cellular changes in the 30-90 days (far too short)
of their studies. Only when gross changes occurred in the animals did this
usually meet their criteria as unsafe.
Data can be reported correctly and still be ignored or misinterpreted if it
meets the paradigm of the review committee or their major funders. The
other tricks with pesticide and herbicide testing include tests of too short
a duration, measuring insignificant enzymes, and failing to conduct the
tests in field conditions, I. e. after exposure to sunlight or in
combination other with routinely used chemicals. If the test animals are
provided a diet superior to what is normally encountered (high in
antioxidants or natural detoxifiers) this too will skew the results. It is
possible to manage chemical sensitivites in humans with nutritional support,
so why can't it be done in animals also?
A perfect example is the latest and very predictable flap over Viagra and
Researchers and government agencies can be bought. If meeting your mortgage
payment means maintaining funding from a pesticide company how can one
possibly be objective?
Pfizer's Viagra 'dangerously rushed' to market
Last Update: 6:41 PM ET Aug 20, 1998
WASHINGTON (AP) -- Charging that Pfizer's impotence drug Viagra was
"dangerously rushed" to market, a consumer group asked federal regulators to
reexamine the risks posed by the drug to certain patients.
Dr. Sydney M. Wolfe of the Public Citizen's Health Research Group said
Thursday the instructions for using Viagra fail to adequately warn about the
possible effects of the drug on patients who have certain heart or
"Viagra affects blood vessels in many parts of the body," said Wolfe. "These
effects are very worrisome."
Pfizer (PFE) said in a statement that the drug "is safe and effective when
used" properly. The company said 3.5 million prescriptions, or 30 million
tablets, have been dispensed in the four months since the drug was approved.
Wolfe petitioned the Food and Drug Administration to immediately convene an
advisory committee to consider the risks associated with Viagra. There have
been at least 39 deaths among American Viagra drug users, but the cause of
death is not known for 13 patients, and key medical information is missing
for some others.
Brad Stone, a spokesman for the FDA, said that the agency would consider the
proposal submitted by Wolfe, but added, "With the data now available, we
still believe that Viagra is safe when used according to the labeling."
Wolfe said Viagra was approved as part of a "dangerously rushed" process
that carried the drug from submission to FDA approval in just six months and
without consideration by an FDA advisory panel.
The FDA-required labeling warns that Viagra should not be used by heart
patients who are taking nitroglycerin or other nitrate drugs. The
combination can cause a sudden, and possibly lethal, drop in blood pressure.
But Wolfe said "we have concerns for three groups of patients who are not
included in the label warnings." The American College of Cardiology and the
American Heart Association on Aug. 10 also cautioned doctors to be careful
about prescribing Viagra for these patient groups.
The three groups are patients with:
-Reduced blood flow to the heart, but who are not being treated with
nitrates. If such patients take Viagra and then experience a heart attack,
treatment with nitrates could be lethal.
-Congestive heart failure and low normal blood pressure.
-High blood pressure being treated with a complex variety of drugs.
The Viagra instructions also warn about possible side effects among patients
who are taking two drugs, erythromycin or cimetidine, or who have liver or
kidney disease. All of these can cause Viagra to stay in the body longer.
Dr. Adolph M. Hutter Jr. of the Massachusetts General Hospital, chairman of
an American College of Cardiology panel, said that it is clear that "the
combination nitrates and Viagra is deadly", but it has been less widely
known that other heart conditions can be affected by Viagra.
"It can be dangerous for some patients to take Viagra even if they are not
on nitrates," he said.
Hutter said that the ACC is not calling on the FDA to make changes in its
approval of Viagra, but that doctors "need to exercise caution" in
prescribing the drug for patients in those three groups.
"We felt the current regulation of Viagra by the FDA is adequate for the
data that has accumulated," said Hutter.
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