NIH RECOMMENDS MELATONIN BAN- WURTMAN AGENDA XPOSED
Question:
Drs Hughes and Singer at Oregon Health Sciences U report(in HEALTH magazine on aol) that they observe that oral melatonin(dose unstated) reduces stages 3 and 4 sleep 40% in people under 60 or so.
I sleep less, yet rest better, when I take melatonin (3mg). I take it only when need to get a night’s sleep in 5 hours or less. Aside from vivid dreams, I have experienced no no side effects. I’d rather see NIH banned than melatonin. Alex.
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I guess we better all stock up on melatonin – for the over 40 crowd
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: Why is your quest for profits any better than a drug company’s? How much : were you paid to post this message? I am not the original poster, but I will answer the question. I am not getting paid to write the answer. Because there is a competitive market for the manufacture and sale of melatonin now, the poster’s company makes less profit per unit of melatonin sold than the drug company would. Assuming you are a potential melatonin user instead of a drug company owner, you should think this is a good thing. In the situation the poster is trying to prevent, over-the-counter melatonin would be banned and the drug company would have a patent on some trivial melatonin analogue. Patents create monopolies and thus boost profit margins; this is their purpose. This is arguably a valid goal if the patent is truly a patent of something innovative. Given that melatonin works, the patent obviously would not be a patent of something innovative. Tim Freeman
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Right on on your criticizms, Steve. I see too much hype on all this stuff these days….It’s good to keep it all in perspective. All these materials are good tools, but none of them does everything that is claimed for them. The human body (and biology in general) is the miracle, not the vitamins and other nutrients we feed
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Why is your quest for profits any better than a drug company’s? How much were you paid to post this message? J
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Why the ban??? AS a physician, I feel that alternatives are important. No you dont need megamiligrams of melatonin per day and the taking of melatonin needs to be timed with circadian rhythms to be of any help. The US Army Special Ops teams have been using it for years. As a US Army National Guard Flight Surgeon I can recommend for pilot on sustained ops. It is good stuff….our body makes it!!!
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Drs Hughes and Singer at Oregon Health Sciences U report(in HEALTH magazine on aol) that they observe that oral melatonin(dose unstated) reduces stages 3 and 4 sleep 40% in people under 60 or so. Since they are among those who know what stage sleep their subjects are in( not like mit study on melatonin where they use a deadman release, which only registers sleep or non-sleep), this info made me stop short. They are also quoted as saying, as you indicate, that if you could mimic what the pineal actually does, in the right amounts and rhythms, you could do some good. I can forward that article to at least some email addresses, if desired. Isn’t it curious that so few people ask what kind of sleep various substances induce? Joe casey
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And made a lot of money along the way. LEF’s announcements are uniformly $elf-$erving. They call themselves a "Non-Profit Foundation," but make very big money for their principals. Caveat emptor.
Do you have evidence that the "principals" of LEF are making big salaries? I agree that if they are, it weakens their credibility. Dave Gore
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Why is your quest for profits any better than a drug company’s? How much were you paid to post this message?
I think it’s plain that John Hammell is employed by the LEF, and that the accessibility of melatonin as a supplement is in the LEF’s interest, but I don’t think that necessarily discredits him - after all, he scarcely makes a secret of this. The question is, is there any justification for changing the way melatonin is regulated, or is the whole thing a beat-up by profiteers? The way to resolve the question is not to go by personalities, but to look at the available science – none of which to my knowledge suggests that melatonin use is more harmful than the use of other dietary supplements. I’d like to hear any evidence to the contrary; I don’t presently regard melatonin as sufficiently well-tested for my own regular use, though I think it’s a fine cure for jetlag. But my mind is open and it may be that in a few years I will want to use it as a supplement – so I don’t much care for the idea of people driving up its price without a good reason. — | http://www.zip.com.au/~pete/ | Give away what you don’t need. |
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John Hammell, PR man for the Life Extension Foundation (LEF), writes: More than 4,000 studies document that melatonin is the best anti- aging therapy in the world.
Pure garbage. No melatonin researcher in the world would make this claim – not even Pierpaoli and his group, who have heavily pushed the anti-aging thesis. A lot of melatonin researchers – including those who use it for other purposes – dispute the fact that melatonin has *any* anti-aging effects. I say this, incidently, as a user of melatonin myself. Melatonin slows aging, prevents cancer, boosts immune function, keeps arteries from clogging, and maintains youthful neurologic function. Melatonin is almost 100% effective in inducing youthful sleep patterns to enable people to awaken com- pletely refreshed.
This kind of hype is why a lot of people don’t take the life extension movement seriously – and why *no one* should take John Hammell and LEF seriously. When evidence of melatonin’s remarkable anti-aging benefits began to pour out of prestigious research centers throughout the world, The Life Extension Foundation took the bold step of offering melatonin for sale directly to the American people!
And made a lot of money along the way. LEF’s announcements are uniformly $elf-$erving. They call themselves a "Non-Profit Foundation," but make very big money for their principals. Caveat emptor.
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*snip* This kind of hype is why a lot of people don’t take the life extension movement seriously – and why *no one* should take John Hammell and LEF seriously.
For the past three years I have found The Life Extension Foundation to be most helpful for myself and family. Regards, Len
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FOR IMMEDIATE RELEASE August 21, 1996 FOR ADDITIONAL INFORMATION CALL: William Faloon, V.P. The Life Extension Foundation 800-841-5433 or John Hammell, Political Coordinator LEF Political Office 800-333-2553 WURTMAN CAUGHT IN CONFLICT OF INTEREST OVER MELATONIN The Life Extension Foundation first issued a press release exposing the greed and conflict of interest of Richard J. Wurtman of Interneuron Pharmaceutical company over his effort to create a monopoly in the sale of the hormone melatonin on October 1,1995. Wurtman, and other holders of use patents for melatonin would like the product banned as a dietary supplement in order to pave the way for them to make huge profits selling the hormone as a drug,at the expense of consumers. Hundreds of peer reviewed scientific journal articles thoroughly document the numerous benefits of the hormone which has been accurately touted in the media as a natural cure for insomnia and jet lag. Millions of satisfied customers world wide vouch for its effectiveness, and the FDA has only received 4 complaints of adverse reactions over the past 3 years. By the admission of Robert Moore, Ph.D. of FDA’s Office of Special Nutritionals, none of these complaints were substantive or poses any ground for a ban. Numerous press releases and news broadcasts over the past two years have featured quotes from Dr. Wurtman in which he is always identified as a "researcher from MIT", but never as the CEO of Interneuron Pharmaceutical Co. which has use patents on the whole serotonin pathway, which includes melatonin, and which has a vested business interest in removing the natural substance from the dietary supplement market in order to allow Interneuron to monopolize its sale and to generate huge profits at the expense of consumers. The most recent press release which attempts to scare consumers away from melatonin sold as a dietary supplement appeared in the Washington Post on August 20, 1996 titled "Researchers Urge Skepticism on Melatonin- At NIH Sponsored Meeting, Scientists Say Claims for Hormone are Largely Unfounded" Calling for clinical drug trials, the article termed the current unregulated sale of melatonin a "vast uncontrolled experiment whose outcome is unknown." To this Wurtman added, "This is to some extent scary." Wurtman went on to add that "When it comes to melatonin sales, there is nobody minding the store right now." The NIH melatonin workshop was comprised of a number of researchers, most of whom have use patents on melatonin, who would simply like to conduct controlled clinical trials leading to FDA drug approval, but in order to sell melatonin as a drug and bring in huge profits, Wurtman and his cronies must first get it banned as a dietary supplement- hence the scare tactics. Along with Wurtman, Alfred J. Lewy and Robert L. Sack from Oregon Health Sciences University are also screaming loudly to ban the product as a dietary supplement because they are the holders of patent # 5,420,152 "Methods of Treating Circadian Rhythm Disorders," and would like to be able to bring in huge profits by selling the natural substance as a drug. Their patent was issued on May 30, 1995. Melatonin is the hottest health subject the news media is covering, but contrary to Wurtman and companies allegations that evidence is "lacking" for claims made about it, a quick computer search of any online medical database such as Medline reveals literally hundreds of peer reviewed studies. Within the last 12 months, melatonin has been prominently featured as a potential breakthrough therapy to cure insomnia, prevent cancer, and slow aging. The following is just a brief list of media spots melatonin has been featured in: Newsweek August 7, 1995…"Scientists say this hormone could reset the body’s aging clock, turning back the ravages of time." Tony Brown’s Journal -PBS Sept 16, 1995… "Melatonin is the most potent antiaging agent yet discovered" CBS Evening News early September 1995…"Melatonin has made me feel many years younger now that I can finally get a good night’s sleep" Miami Herald August 14, 1995… "You can get 30 more years of health life, putting us over the century mark" (this story has appeared in most major newspapers throughout the U.S.) Would these media sources publish news stories about melatonin without first reviewing the medical literature? No. Of course not. Their credability is at stake. A tremendous volume of scientific evidence backs these claims. The SAFETY of melatonin is also well established in the peer-reviewed published literature. While most Americans take a 3 milligram melatonin supplement to help them sleep and slow aging, studies conducted on humans show that doses of 40 milligrams, 75 milligrams, 300 milligrams and even up to 1000 milligrams can be taken daily with no adverse effects. What this means is that if a person swallowed all the melatonin capsules contained in a typical bottle (60 capsules x 3 milligrams = 180 milligrams), there would be absolutely no toxicity based on published studies in which much higher doses have been safely given to humans. Melatonin is so safe and effective, that Dr. Richard J. Wurtman has recently obtained a patent to sell this natural hormone as a sleeping pill (refer to Exhibit A- Wall Street Journal Sept 14, 1995). If Dr. Wurtman is going to succeed in monopolizing the sale of melatonin, he must get the Food and Drug Administration to classify melatonin as a "drug" instead of the natural nutritional supplement status it now enjoys in health food stores. On September 28th, 1995, on NBC Nightly News, Richard Wurtman, MD of MIT alleged that the hormone melatonin has "dangerous side effects" and stated: "I’m really scared that someone’s going to take chronic doses of melatonin in high doses for a long time, and have all kinds of disturbances in their other biologic rhythms, maybe drive into a telephone pole." (Exhibit B: Transcript of News Broadcast) Following Wurtman’s statement, NBC newscaster Robert Bazell stated: "Another fear- melatonin is sold not as a drug, but as a food supplement like vitamins. A law recently passed by congress restricts the Food and Drug Administration’s ability to regulate food supplements. While there have been no reports of adverse reactions from melatonin, six years ago a manufacturer accidentally contaminated another food supplement used for sleep called tryptophan, with an unknown toxin. Forty-five people were killed and hundreds were disabled in this country alone." (Exhibit B: Transcript of News Broadcast) (What Bazell either failed to point out, or was unaware of, is the fact that with the passage of the Dietary Supplement Health and Education Act of 1994 on October 8, 1994, the law was changed so that from now on, dietary supplement manufacturers will be required to conform to stringent quality control requirements known as "Good Manufacturing Practices" or "GMPs". The Life Extension, and the most dietary supplement companies have always employed sound GMPs, and now all such companies will, so Bazell’s statement regarding tryptophan can only be viewed as alarmist. In addition, the statement that the contaminant in l-tryptophan is "unknown" is not true, and casts unreasonable doubt on the safety of l-tryptophan, and by extension other natural products. In fact, the contaminant in l-tryptophan was identified as "peak E" by the CDC and the FDA. (Exhibit C: Letter from Cleary, Gottlieb, Steen and Hamilton 1752 N. St.NW Washington DC 20036), "Characterization of "Peak E," a Novel Amino Acid Associated with Eosinophilia Myalgia Syndrome" Myeno, et.al., Science, Vol. 250 December 1990 p.1707-1708.) In addition, Christopher Caston, MD, developed and patented a nutritional protocol for treating eosinophilia myalgia syndrome (the disease resulting from the contaminated l-tryptophan) which contains l-tryptophan. (The fact that this successful treatment protocol contains l-tryptophan explodes the contention that l- tryptophan itself caused eosinophilia myalgia syndrome, yet the FDA refused to examine Caston’s life saving work. (Refer to Exhibit D: Advances in Therapy, Vol 7, No.4 July/August 1990 "Treatment of Refractory Eosinophilia-Myalgia Syndrome Associated with Ingestion of L-Tryptophan Containing Products" (Caston,et.al.) and Advances in Therapy, Vol.9 No. 5, September/October 1992 "Treatment of Refractory Eosinophilia-Myalgia Syndrome Associated With the Ingestion of L-Tryptophan Containing Products With Divalproex Sodium: Case Reports" by Caston,et.al.) (For proof that the FDA ignored Caston’s life saving work and attempted to cover it up and to smear l-tryptophan, see Exhibit E: Transcript of the FDA Dietary Supplement Hearing August 29,1990 Masur Auditorium, NIH- p.62-66. testimony of John C. Hammell. Also see letter from Patricia Gee, FDA FOI Staff to John Hammell April 10, 1992) (It should be noted that Wurtman also holds a use patent on l- tryptophan, and for years has wanted to monopolize its sale in the form of a drug analog, just as he is trying to now with melatonin.) (Exhibit F: Statement by Richard J. Wurtman, M.D. Before the Committee on Government Operations July 18, 1991) Pioneering research scientist William Regelson, M.D., of the Medical College of Virgina challenges also challenges Bazel’s assertions and states that Wurtman’s real agenda is to attempt to get the FDA to remove melatonin from the OTC marketplace in order to make way for him to sell a melatonin analog that Wurtman is developing and for which he holds a patent. The US Patent Office indicates that on September 12, 1995 patent number 5,449,683 was issued to Wurtman on "Methods of Inducing Sleep Using Melatonin." (Exhibit G) Dr. Regelson states … read more »
