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Skeletons in the FDA’s Closet
By: Shane Ellison
Edited by: Gil Eriksen
It is time that the actions of the Food and Drug Administration (FDA)
speak for themselves and Americans began to question their own absorbent
use and blind-loyalty to FDA approved drugs. If not, you too may become
a FDA statistic. The FDA’s financial ties to “big-pharma” have caused
millions of preventable deaths over the last 30 years.
In 1996-97 the FDA approved a drug known as Posicor (a chemical called
mibefradil dihydrochloride) for the treatment of high blood pressure
(hypertension). Prior to approval, the data from the congestive heart
failure trials presented at a FDA Advisory Committee meeting on Posicor
showed that more patients treated with Posicor died than those taking a
placebo! After its release for use by the public 200 more Americans
died from using Posicor as prescribed. It was finally removed from the
market in 1998.
To treat high cholesterol, the FDA has approved synthetic chemicals
known as “statins”. Brand names include Zocor, Lipitor, Pravachol,
Mevacor, Baycol, and Lescol. Unknown to the public and most doctors,
statin drugs can be life threatening. In a letter to the Archives of
Internal Medicine, Uffe Ravnskov MD, PhD and colleagues show that in two
of the three clinical trials that included healthy people, the chance of
surviving was better without treatment of statins. Researchers from
the University of Denmark report that about 15% of statin users over the
age of 50 will suffer from nerve damage. Since cholesterol is
manufactured in the liver, it remains to be seen just how much liver
damage the consuming public will sustain when the internal organ
injuries are factored in. USA Today reported, “Statins have killed and
injured more people than the government has acknowledged”. To add
insult to injury, there are no studies linking high cholesterol directly
to heart disease. Wrap your brain cells around that! Factors that can
be linked to heart disease are high levels of homocysteine within a
person’s body. But that’s a problem that can be cured with the proper
ratios of B vitamins and folic acid. Translation, no profit for doctors
or drug companies.
Pop Quiz: Who profits when you get sick from statins?
In 1998 the FDA attacked retail suppliers of Red Yeast Rice (RYR), a
food that is known for lowering cholesterol. FDA squads and U.S
Marshals raided numerous supplement providers and stole the product from
their shelves. Shortly thereafter, the FDA sent letters to all
providers of RYR demanding that they remove RYR from their stores.
Interestingly, clinical trials demonstrated RYR to be more effective (by
17-21%) at lowering total cholesterol and inhibiting HMG-CoA reductase
(the enzyme that produces cholesterol in the body) than the
aforementioned life-threatening statins. Clinical trials also
demonstrated that RYR has zero negative side effects. So if you really
wanted to lower high cholesterol levels, you could do so with food that
would not “kill you by accident”.
The Art of Corporate Drug Pushing
Since their 1998 raids, the FDA has continued to denounce the clear
winners like Red Yeast Rice and promote the use of losers like the
patented synthetic statins for lowering cholesterol. The media and
doctors continue to tell us that synthetic statins will help prevent
heart attacks and strokes. More recently they have added the prevention
of Alzheimer’s Disease (AD) to the list of benefits that can be had by
the use of statin’s. These drugs however are known to cause nerve
damage in older patients and nerve damage within the brain is one of the
causes of AD. What gives? That statins can prevent AD is a fallacy.
This is typical regurgitated dogma from high paid complacent doctors and
talking heads within the media. It is also an excellent way to push
more pills on the laymen who doesn’t have a strong understanding of
drugs and disease.
The Kids will Love it! And so will the shareholders of Eli Lilly!
In 1987 the FDA approved Prozac to treat depression. In 1985 the
manufacturer, Eli Lilly, conducted tests on Prozac and found the drug
was no more effective than a placebo. As a remedy for these
insignificant figures, an FDA statistician suggested that Eli Lilly
might evaluate the test results differently to produce a more favorable
statistical result for Prozac. Clinical studies performed on Prozac
showed 191 negative side effects per 100 people. That is almost two
negative side effects for every user of the drug! Two months before the
FDA approved Prozac there had already been 27 deaths from the controlled
clinical trials. By 1992 Prozac had already scored another 28,600
documented adverse reactions plus an additional 1700 deaths according to
an FDA report.7 I guess you could say that death is a pretty strong
“adverse reaction” from a pill. But look on the bright side…it’s your
last one! In 2003, the FDA approved Prozac for children.
To help the drug companies push more poison the FDA approved
direct-to-consumer (DTC) advertising. Now that it’s legal,
pharmaceutical companies are spending about $2 to $3 Billion annually to
unleash false advertising campaigns directly to the public. FDA
officers report that pharmaceutical companies have been in violation of
the Food, Drug and Cosmetic Act (FDCA) over a hundred times each year by
overstating benefits and not accurately reporting negative reactions to
drugs. To date, no pharmaceutical company has been charged by the FDA
for violations of the FDCA.
Closing
How is it that the FDA can get away with approving drugs that are known
to be deadly? Moreover, how can the FDA continue to allow
pharmaceutical companies to advertise false information about FDA
approved drugs? And finally, why does the FDA only take public safety
into account when it is forced to by some form of gross public error?
An insider testimony offers an explanation. As published in the British
Medical Journal, Paul Stolley, MD, MPH, a former senior consultant to
the FDA, says “the agency neglects drug safety in its rush to speed the
drug-approval process because current laws and policies let the drug
industry influence FDA decisions”. Federal law prohibits the FDA from
using experts with financial conflicts of interest to decide whether or
not certain medications should be approved. Yet the FDA has waived the
restriction 800 times since 1998! In fact, USA Today reported that more
than half of the experts hired to advise the FDA on the safety and
effectiveness of medicine have direct financial relationships with the
pharmaceutical companies that will be helped or hurt by their decision.
Historically, the FDA has revealed when these financial conflicts exist,
but these conflicts have been kept secret since 1992. Hence, it is
impossible to determine the amount of money or the pharmaceutical
company involved.
If we truly want health freedom it is time that we seek out natural
alternatives that are not FDA approved. The aforementioned examples are
not isolated cases. Scientists writing for the British Journal of
Clinical Pharmacology wrote that, “A random journey through the
Physicians Desk Reference (PDR) underscores the fact that most drugs are
poisons which have a few beneficial side effects”. It is time that
Americans took responsibility for their health or face the consequences
of becoming a lifetime asset to “big-Pharma”.
References:
1. JAMA, Dec 22/29 1999 - Vol 282, No. 24
2. Cohen, S. Jay. Over Dose. 2001. ISBN 1-58542-123-5
3. Uffe Ravnskov, et al. Letter to Archives of Internal Medicine,
submitted on July 20,2002
4. Julie Appleby and Steve Sternberg, USA TODAY. 08/20/2002
5. Sternberg, Steve. USA Today. 08/20/2001
6. http://www.prozactruth.com/fdalilly.htm
7. Cohen, S. Jay. Over Dose. 2001. ISBN 1-58542-123-5
8. The Lancet. October 6, 2001;358:1141-1146
9. Graedon, Joe. Writing for L.A Daily Times. November 21, 2002
10. Department of Health and Human Services. Food and Drug
Administration. Nov. 14, 2000
11. Cohen, S. Jay. Over Dose. 2001. ISBN 1-58542-123-5
12. DeNoon, Daniel. Drug Safety Not FDA Priority. WebMD. Sept 12,
2002
13. Cauchon, Dennis. USA Today. 09/25/00
14. Moride Y, et al. British Journal of Clinical Pharmacology. 1997;
43:177-181
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