Shane Ellison -- Skeletons in the FDA's Closet

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".

Footnotes:

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