A Glorious Victory Over FDA Tyranny

Durk Pearson and Sandy Shaw have won an unprecedented legal victory that has eviscerated the FDA's power to censor truthful scientific information. The most significant aspect of this case is that it was won on Constitutional grounds. Previously, the FDA trampled on the Bill of Rights as if this precious document were a worthless piece of paper. In this 3-0 Appellate Court ruling, the FDA was told that it had to abide by the free speech protections guaranteed by the First Amendment to the United States Constitution. This triumph adds to an eight-year string of defeats the FDA has suffered in the Federal Courts.

When the FDA attacked The Foundation in 1987, the agency was considered to be invincible by every legal expert in the country. Prior court rulings had given the FDA arbitrary power to censor scientific information, and it was considered impossible to defeat the FDA on Constitutional grounds. In 1987, our attorneys advised us to shut down the Life Extension Foundation, since our primary function was to disseminate information about nutrients and drugs that the FDA did not approve of.

We did the opposite of what our attorneys advised and set out on a mission to challenge the FDA's unconstitutional authority. The FDA retaliated by launching a criminal investigation that resulted in a 27-count Federal indictment against Saul Kent and myself in 1991. We faced a realistic five to 20 year prison sentence. (The Federal government dismissed the criminal indictments against us in 1995 and 1996).

The most significant impact of our standing up to the FDA was that it encouraged others to do the same. Instead of capitulating to FDA dictates, victims of FDA persecution, such as Jonathan Wright, M.D., Stanislaw Burzynski, M.D., Roger Sless, Stephen Levine, Ph.D. and countless others, challenged FDA authority, and in every single case, prevailed against the agency.

The importance of this most recent legal victory in favor of the health and freedom of the American citizenry cannot be overstated. The remainder of this editorial provides a starling example of what happens when an authoritarian bureaucracy exercises unconstitutional power over the American public.

Heart Disease and the Year 1950

Craig Cooney, Ph.D. is a scientist who until recently worked with the FDA. He now works with The Life Extension Foundation on a research project at the University of Arkansas to determine if enhancing methylation can extend life span.

Dr. Cooney recently conducted a search of the old literature for references about methylation and cardiovascular disease and came across some interesting findings. He found a series of articles dating back to the early 1950s that describe how high doses of methylation-enhancing nutrients such as TMG and choline can be used to treat both coronary and congestive heart failure.

Back in the 1950s, supplement companies would have liked to have advertised these studies showing that choline and TMG might protect against heart disease, but the FDA would have defined these vitamin products as "unapproved new drugs" and shut the companies down.

How many Americans died because of FDA censorship on this one issue? Nobody will really know because the effects of knowledge withheld cannot be measured retroactively. About one million Americans die every year from diseases related to arteriosclerosis (arterial occlusion) and thrombosis (clotting inside a blood vessel). There are several known causes of blood vessel disease, but homocysteine continues to show itself to be a primary culprit. Homocysteine can directly cause the initial damage to the arterial wall, contributes to plaque buildup, induces coronary artery spasm and causes abnormal blood clots inside of blood vessels. Homocysteine can be lowered by supplementation with vitamin B6, B12, folic acid, choline and TMG.

We speculate that several million Americans needlessly died of heart attack or stroke since 1950 because the FDA banned vitamin companies from informing the public that supplements could protect against the development of cardiovascular disease. It's not just FDA interference that causes Americans to needlessly die. In 1996, Life Extension Foundation published an article (Life Extension magazine, Aug 1996) explaining that high levels of fibrinogen was a risk factor for having a heart attack. Despite Foundation members showing this article to their cardiologists, almost all of the doctors ridiculed this theory and would not even test member's blood for this dangerous clotting factor. (This is one reason the Foundation established its own blood testing laboratory).

A new study in the Journal of the American College of Cardiology (1999;33:1347-1352) supports our position on fibrinogen and heart attack risk. This published report examined data on nearly 400 male physicians participating in the Physicians' Health Study. Blood fibrinogen levels of 199 subjects who experienced heart attack during the study period were compared with those of 199 control subjects who did not suffer heart attacks. The investigators report that patients with heart attack had significantly higher fibrinogen levels compared with healthy controls. In fact, subjects with especially high fibrinogen levels had a risk of heart attack twice that of men with lower levels of the blood-clotting agent (fibrinogen). These findings remained unchanged regardless of the presence or absence of other coronary risk factors, including high cholesterol. The authors stated that these findings "support the conclusion from other prospective studies that fibrinogen is a strong and independent predictor for ischemic heart disease."

Fighting the medical establishment is not easy. The Journal of the American Medical Association (JAMA; Apr 21 1999) published an article recommending that people increase their vitamin C intake from 60 mg to 200 mg a day. This seven-page article provides persuasive arguments about the health benefits of vitamin C, yet emphasizes that people should obtain their vitamin C from food instead of supplements. The most glaring contradiction in the article is that it stated that median vitamin C ingestion from food in the United States is only 84 mg a day, yet the authors somehow expect doctors to educate their patients to radically alter their dietary habits to eat more fruits and vegetables in order to obtain 200 mg a day of vitamin C. We appreciate the American Medical Association publishing an article that challenges the FDA's contention that people only need 60 mg a day of vitamin C, but regret that conventional doctors are still reluctant to recommend even low potency (200 mg vitamin C) supplements.

Each month, The Life Extension publishes new facts to support the theory that government coercion has no place in the regulation of medical science. Since our anti-FDA position is subjected to a lot of scrutiny, we use very conservative models to spell out how many people may have died because of bureaucratic malfeasance. The FDA's suppression of the benefits of B-vitamins has probably resulted in millions of unnecessary heart attacks and strokes over the last 49 years. The sidebar on page 8 reveals published studies from the early 1950s showing that homocysteine-lowering supplements protect against cardiovascular disease.

The carnage is not over. FDA bureaucrats still prevent Americans from obtaining proven medical therapies from other countries. This results in the needless deaths of thousands American citizens every year when life saving treatments have already been discovered, but are not yet approved by the FDA. In this issue, we include a letter that we urge all Americans to send to Congress to protest the FDA's continued Constitutional violations that are denying Americans the right to life and liberty guaranteed by the legal documents that this country was founded on.

William Faloon
Vice President
Life Extension Foundation