Dr James Schaller
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The FDA Raids One of Their Major Opponents:
An Abuse of Power?

The Battle to Allow American's Freedom to Purchase Affordable Canadian Scripts Reaches New Bizarre Low

"A government that's big enough to give you everything you want is big enough to take it all away."
Barry Goldwater

LEF has recently been investigated by the FDA. Why?

On July 16, 2003, the FDA appeared at our door and began an intrusive 5-day inspection of our offices. This effectively shut our legal team down for a week. We believe that the FDA is trying to thwart Life Extension's because we have been the leading proponent of a bill that would permit Americans to legally import lower-cost prescription medications from other countries. We suspect that the pharmaceutical lobby instigated the FDA's unwarranted investigation of us.

You've taken controversial stands from the start.

Starting in 1980, the Life Extension Foundation began to uncover methods to prevent and treat diseases that were being overlooked by mainstream doctors. Even though these methods were substantiated by thousands of scientific studies, practicing physicians were largely unaware of this life-saving information and many of their patients were needlessly suffering and dying. For example, in 1980, we were the first to recommend antioxidants to prevent disease. In 1981, we introduced DHEA as a disease-preventing therapy. In 1983, we were the first to recommend coenzyme Q10 to prevent and treat heart disease. In 1985, we introduced lycopene, the antioxidant so prevalent in red-colored foods like tomatoes, as a potential preventive for cancer. Lycopene is finally gaining widespread acceptance today. Almost every year since, we've introduced new ideas about extending health and longevity. If you look at the Life Extension Website (www.lef.org), you can see our 24-year track record that reveals how far ahead of conventional medicine we have been.>p>

How was your work first accepted?

We were ridiculed by the medical establishment and viciously attacked by the FDA. When we recommended aspirin to prevent heart attacks in 1983, we were heavily criticized by both conventional and alternative medicine. The FDA began investigating us in 1983. Our facilities were raided at gunpoint in 1987 and again in 1991. We were indicted on criminal charges at the end of 1991 and thrown in jail, facing long prison sentences for alleged FDA violations. We fought back. After both the 1987 and 1991 raids, we went to court and won our dietary supplements back. It took until 1996 for us to convince the Federal government to dismiss the entire criminal counts against us. Also, our activism resulted in the 1994 passage of the Dietary Supplement Health and Education Act that kept the FDA from banning consumer access to many important supplements. We have also been involved in First Amendment lawsuits against the FDA that has kept the agency from censoring truthful, non-misleading health information that the public needs to hear. Today, the FDA continues to focus on us as their number one political dissident. The FDA has a legitimate role in protecting people from toxic drugs and negligent practices, but we believe some factions within the FDA have become pawns of pharmaceutical company lobbyists who would like to see natural medicine banned. To understand more about this issue, see www.stopfda.org.

What were you saying that rankled the FDA so much?

Here's an example. In 1981, Life Extension suggested folic acid to reduce heart attack risk. When medical research showed that folic acid prevented neural tube defects in infants, we published this. The medical establishment jumped on this bandwagon rather early, too. Obstetricians were prescribing multi-vitamins to pregnant women even though the relationship between folic acid and birth defect prevention was fully proven. What doctors did not know was that to prevent neural tube defects, a woman should have adequate folate status upon conception. This means that all women who might become pregnant should consume at least 400 mcg of folic acid each day. We supported this because the scientific evidence was irrefutable and conventional doctors accepted it, yet the FDA was not letting the claim be made.

What is the difference in the FDA's view about supplements vs. yours? I know people at the FDA, primarily in the clinical pharmacology and the drug evaluation divisions, and they are dedicated, knowledgeable people. What about the FDA's enforcement division and how they interpret the law today?

The difference between how the FDA views supplements in 2004 compared to year 1983 is that Congress has greatly removed the arbitrary power of the FDA to declare a dietary supplement an unapproved drug. In 1979, for instance, the FDA indicted executives of GNC for putting books and magazines too close to evening primrose oil products on store shelves. The FDA declared that the placement of independent books/magazines that describe the benefits of the fatty acids found in primrose oil constituted a drug claim. According to the FDA's logic at the time, the GNC executives committed a crime by selling the primrose oil and the books/magazines in the same vicinity. The GNC executives plead guilty in Federal Court to the FDA's criminal indictment. This kind of FDA abuse caused Congress to pass laws that limited the FDA's arbitrary authority to declare a dietary supplement a drug merely because of a health claim. As of year 2004, the FDA permits biological structure/function claims and some nebulous disease claims for supplements, such as "helps maintain healthy joints". The FDA is still objecting to saying a particular supplement might help alleviate "arthritis". This is unfortunate, since published scientific studies consistently show that, for example, glucosamine and chondroitin effectively alleviate pain, immobility, inflammation, and cartilage degeneration in arthritis patients. In your last newsletter, you had an excellent article about the overwhelming scientific evidence published in leading medical journals about fish oils preventing 40%-75% of the sudden cardiac death, which kills 250,000 Americans a year, yet we cannot make this claim for our fish oil products. The most recent petition Life Extension has filed against the FDA seeks to have the agency recognize scientific findings from U.S. government-funded studies. In this instance, an agency of the Department of Health and Human Services funded a study whose findings revealed that s-adenosyl-methionine (SAMe) is effective in the treatment of depression and arthritis. Since taxpayer dollars were used to pay for this study, and it is in the public domain, Life Extension's contention is that companies that sell SAMe should be able to cite the study's conclusions about SAMe's safety and efficacy. If the FDA rejects this petition, Life Extension will litigate.

For more information about Life Extension Foundation visit their website.

William Faloon is a Director of the Life Extension Foundation. His views do not necessary reflect those of MedicationSense.com or Dr. Cohen.

Copyright 2004, Jay S. Cohen, M.D. All rights reserved. Readers have permission to copy and disseminate all or part of these articles if it is clearly identified as the work of: Jay S. Cohen, M.D., the MedicationSense E-Newsletter, www.MedicationSense.com. You may not use this work for commercial purposes.

NOTE TO READERS: The purpose of this E-Letter is solely informational and educational. The information herein should not be considered to be a substitute for the direct medical advice of your doctor, nor is it meant to encourage the diagnosis or treatment of any illness, disease, or other medical problem by laypersons. If you are under a physician's care for any condition, he or she can advise you whether the information in this E-Letter is suitable for you. Readers should not make any changes in drugs, doses, or any other aspects of their medical treatment unless specifically directed to do so by their own doctors.

Dr. Schaller neither supports nor refutes this material and cannot check the accuracy of any comment above. Readers are invited to contact the FDA directly for their opinion on Mr. Faloon's interview.

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