Jay S. Cohen M.D.       http://medicationsense.com      1337 Camino Del Mar   Suite C       Del Mar, CA 92014       Phone: 858.345.1760       Fax: 858.509.8944


An Interview with Bill Faloon of the Life Extension Foundation: A Recent Clash with the FDA Places the Spotlight on the Largest Anti-Aging, Research and Supplement Organization in the U.S.

Is Life Extension Possible? Where Does Anti-Aging Stand Today?

1. LEF has been conducting anti-aging research since 1980. Why?

We are all aging to death. The mission of The Life Extension Foundation is to conduct scientific research aimed at extending the healthy human lifespan in the short-term. Our ultimate objective is to achieve indefinitely extended longevity free of the ravages of aging and disease.


2. What anti-aging research are you conducting now?

Last year, we supported over four million dollars of pioneering scientific research. The primary focus of our research is to measure the gene expression changes that occur when various anti-aging compounds are administered to animals. We have developed proprietary gene analysis technology that enables us to ascertain the effects of anti-aging compounds in only a few months, rather than wait for the many years it takes when doing lifespan animal research. The significance of this breakthrough (published in the Proceedings of the National Academy of Sciences, Sept 10, 2001) is that we can measure thousands of potential compounds to quickly identify those that may slow or even reverse aging.


3. Life extension: do you think it's actually feasible? What can people do now?

After testing only seven promising compounds using our gene measuring technology, we identified the prescription drug metformin as having significant effects in mimicking the gene expression changes normally seen in calorie restricted animals. Since metformin has many other health benefits, including correcting the "metabolic syndrome" (also known as Syndrome X), we suggest that most aging people (with their doctors) consider taking metformin for its potential disease prevention and anti-aging benefits. However, many people are concerned about drug side effects and may not want to take metformin.


4. Why does calorie restriction prolong life?

First of all, eating less food significantly lowers blood levels of insulin, glucose, cholesterol, triglycerides, and other known vascular disease risk factors. By restricting food intake, one also reduces the amounts of mutagens that are so prevalent in the diet, thereby reducing their risk of cancer. Published studies consistently show that those who consume the greatest number of calories have higher cancer rates. What Life Extension has discovered through our pioneering research is that calorie restriction favorably alters the genes involved in cellular aging. This means that genes that program cells to enter senescence are deactivated, whereas genes that keep cells functioning in youthful, healthy metabolic states remain active or are turned back on. So calorie restriction accomplishes two objectives: it reduces the risk of contracting the most common killer diseases, and it programs genes to extend the maximum lifespan of the organism.

5. Other than major calorie restriction or prescription drugs, are there other methods people can use to accomplish the same goal?

Recently, scientists from Harvard Medical School identified an extract from red grapes (resveratrol) as a substance that can activate a longevity gene that expresses itself in calorie restricted animals. Resveratrol comes primarily from the grape skin and other parts of certain plants. Resveratrol has also been shown to activate a longevity gene in yeast. This same longevity gene expresses itself when humans undergo calorie restriction. Scientists have speculated that humans may derive some of the benefits of calorie restriction by consuming resveratrol supplements. People may reduce their risks of contracting many common age-related diseases by supplementing with resveratrol. But the quality of the resveratrol people take is the key. For two years, Life Extension has worked with a European pharmaceutical company to make available an affordable standardized resveratrol extract with the most consistent potency and bioavailability of any resveratrol extract. Meanwhile, we continue to seek other life-extending methods. In recent years, we have introduced a number of supplements that counteract the many known causes of aging. Protein degradation via the glycation process is one example. We found that high dose carnosine (1000 mg/day) interferes with glycation processes. Aging people suffer from a systemic low level of chronic inflammation that damages virtually every cell in the body. Nettle leaf extract and DHEA help to mitigate the pro-inflammatory cytokines that are the underlying cause of much of this destructive inflammation.


6. Where do you see the alternative health movement heading? What will be LEF's role?

The term "alternative health" conjures up all kinds of medical practices, some of them based on solid science, others having an almost religious connotation. Life Extension tries to separate itself from the broad term "alternative health" because it does not accurately describe what we do. For the past 24 years, we have uncovered pioneering therapies to treat and prevent the diseases associated with aging. Our protocols are substantiated by thousands of studies published in eminent scientific journals. The problem is that practicing physicians are largely unaware of this life-saving information and many of their patients are needlessly suffering and dying. One reason for this travesty is that today's doctors are overwhelmed with a crushing burden of bureaucracy. Hurried doctors cannot possibly keep up with the abundance of new information bursting out of the scientific arena. In order to bridge the gap, The Life Extension Foundation has recently published a 1500-page reference book for consumers and doctors titled Disease Prevention and Treatment. In addition, our 90,000 members receive our 110-page monthly magazine that keeps them updated on the latest medical advances. Still, many people find it difficult to apply the vast amount of new scientific data that emerges every day. That's why Life Extension Foundation maintains a team of physicians and scientists who pore over newly published data to provide the best guidance to achieving a longer, healthier lifespan. When Life Extension members have questions, they have free phone and email access to physicians, a doctor of molecular oncology, and other knowledgeable health advisors. Our website is also another excellent resource. In an era of wild claims from all directions about new anti-aging discoveries, we at The Life Extension Foundation take pride in having the longest track record of in-depth research and scientifically-supported recommendations to help people maximize health and longevity. I encourage your readers to review our novel approaches by logging on to www.lef.org


7. 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.


8. 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.


9. 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.


10. 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.


11. 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.

Information about Life Extension Foundation Life Extension is available at their web site.

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



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