Janurary 1996


The Threat To Melatonin

A major obstacle to progress in healthcare in the U.S. is the enormous cost of obtaining FDA approval to market new drugs. A few years ago the Center for The Development of New Drugs at Tufts University in Boston determined that the average cost of developing and getting approval for a new drug was $231 million.

The enormous cost of FDA approval makes it difficult for any but the largest pharmaceutical companies to be players in the development and marketing of new drugs. In addition to their economic advantage, the large companies also have an edge in "expertise" because of their ability to hire ex-FDA officials to guide them through the FDA's regulatory land mines.

Another problem is FDA bias against companies that promote breakthrough therapies before they gain FDA approval. Examples of FDA bias is their failure to approve the immune-boosting drug isoprinosine and the potent anti-viral drug ribavirin because of the agency's vendetta against the companies selling these drugs, ICN Pharmaceuticals and Newport Pharmaceuticals.

The American public pays a heavy price for the FDA's bureaucratic bungling and biases. Drugs that manage to make it through the FDA's regulatory hoops are delayed for many years, sometimes decades, before Americans can have access to them. And when Americans are finally allowed to purchase these drugs, they cost far more than in any other country on Earth.

The Melatonin Media Breakthrough

A good example of these costs is the current threat to the health benefits Americans are now enjoying from melatonin-the pineal gland hormone that enables people to sleep better and protects them against the ravages of cancer and aging. Members of The Life Extension Foundation have been able to obtain pharmaceutical-grade (99.9% pure) melatonin since 1992. But recent mass media publicity on the benefits of melatonin has made this remarkable therapy a household word.

In the last few months, melatonin has been featured in the mass media as a potential breakthrough therapy to cure insomnia, prevent cancer, and slow aging. The following is just a sampling of media shows and publications that have carried recent stories about melatonin:

• Newsweek Magazine - Aug. 7, 1995..."Scientists say this hormone could reset the body's aging clock, turning back the ravages of time."
• Tony Brown's Journal - PBS Sep. 16, 1995... " Melatonin is the most potent anti-aging agent yet discovered."
• CBS Evening News - early Sep. 1995..." Melatonin has made me feel many years younger now that I can finally get a good night's sleep."
• Miami Herald - Aug. 14, 1995... "You can get 30 more years of healthy life, putting us over the century mark." (this story appeared in newspapers throughout the country).

Melatonin 's safety is well established in the peer-reviewed scientific literature. While most people take a 3 mg Melatonin supplement every night to help them sleep better and to slow aging, studies in humans have shown that doses of 40 mg, 75 mg, 300 mg, and even 1,000 mg can be taken daily with no adverse side effects. What this means is that if a person swallowed all the melatonin in a typical bottle (60 capsules x 3 mg = 180 mg) at once, they would probably suffer no toxic effects.

Because of widespread media reports of the health benefits and safety of melatonin, millions of Americans will soon be sleeping better and improving their odds of living in good health to the age 100 and beyond. Melatonin will not only provide major benefits to individual Americans, but will benefit society as well by helping to lower health care costs and increasing productivity throughout the country.

The only thing holding up this extraordinary health bonanza is the fact that melatonin is currently in short supply because of the sudden, unexpected, large-scale demand for it. But by early next year, there should be plenty of melatonin available to provide enormous benefits for millions of people in the U.S. and abroad.

Dr. Wurtman's Conflict of Interest

However, the FDA's restrictive, "good-old-boys" network is a serious threat to the Melatonin healthcare bonanza. Dr. Richard J. Wurtman of the Massachusetts Institute of Technology (MIT) recently obtained a patent to sell melatonin as a sleeping pill and is seeking FDA approval to market his version of melatonin through his pharmaceutical company (Interneuron). In doing so, Dr. Wurtman is using the cloak of FDA approval to attempt to gain a monopoly on the sale of melatonin in the United States. In order for Dr. Wurtman to monopolize the sale of melatonin, he must get the FDA to classify melatonin as a "drug" instead of the natural nutritional supplement status it now enjoys.

On Sep. 28, 1995, on the NBC Nightly News, Dr. Wurtman alleged that melatonin has "dangerous side effects" and said: "I'm really scared that some-one'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, which might lead them to drive into a telephone pole." What was not said on the show was that Dr. Wurtman has a conflict of interest on the subject because of the tremendous profits he stands to gain if the FDA grants him monopolistic control over the sale of melatonin, and that, as a result, his statements on the alleged "risks" of over-the-counter sale melatonin have no credibility whatsoever!

Following Dr. Wurtman's statement, NBC newscaster Robert Bazell stated that: "Another fear is that 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."

The Truth About Tryptophan

What Bazell failed to point out is that, with the passage of the Dietary Supplement Health and Education Act of 1994 on Oct. 8, 1994, the law was changed to require dietary supplement manufacturers to conform to stringent quality control requirements known as "Good Manufacturing Practices" or "GMPs". The Life Extension Foundation, and most dietary supplement companies have always employed sound GMPs, and now all such companies will to forced to, so Bazell's statement regarding tryptophan can only be viewed as alarmist.

In addition, Bazell's remark that the contaminant in the batch of tryptophan that harmed people is "unknown" is simply not true. In fact, the contaminant in tryptophan was identified as "peak E" in a manufacturing process employed by the Showa Denka company of Japan. This process was never used before and has never been used since the problem was pinpointed by the Center For Disease Control (CDC) several years ago. (Myeno, et al: "Characterization of 'Peak E', A Novel Amino Acid Associated with Eosinophilia Myalgia Syndrome", Science, Vol. 250, Dec. 1990 p.1707-1708.)

Furthermore, Christopher Caston, MD has patented a nutritional protocol to treat eosinophilia myalgia syndrome (the disease caused by the contaminated tryptophan) which contains tryptophan! The fact that this successful treatment protocol contains tryptophan explodes the myth that tryptophan itself caused eosinophilia myalgia syndrome, yet the FDA has refused to consider Dr. Caston's life saving work. (Caston, et al: "Treatment of Refractory Eosinophilia-Myalgia Syndrome Associated with Ingestion of L-Tryptophan Containing Products" Advances in Therapy, Vol. 7, No.4 July/August 1990)

It should be noted that Dr. Wurtman also holds a use patent on l-tryptophan, and has been trying for years to monopolize its sale of a drug analog, just as he is now trying to monopolize the sale of melatonin.

Dr. Regelson's Challenge To Dr. Wurtman

Pioneering scientist William Regelson, MD of the Medical College of Virginia, the co-author (with Dr. Walter Pierpaoli) of the book The Melatonin Miracle (see review in this issue), contends that Dr. Wurtman's real agenda is to get the FDA to remove Melatonin from the over-the-counter market in order to make way for him to sell a melatonin analog that Wurtman is developing and for which he holds a patent (number 5,449,683). Dr. Regelson charges that: "If Dr. Wurtman is successful in his goal to remove Melatonin from the marketplace as a dietary supplement as he pushes his drug analog of melatonin, the price of Melatonin would become astronomical, and a safe product would be made far less available to consumers to the detriment of the public health. Moreover, there would be no guarantee of safety from an unproven analog, while we already know that Melatonin itself is safe."

Since 1992, The Life Extension Foundation has been importing and selling pharmaceutical-grade melatonin (assayed at 99.7%-to-100% purity), verified by Leberco Testing Inc. of Roselle Park, NJ in assay number 958812, May 24, 1995, which was published in the Dec. 1995 issue of LIFE EXTENSION MAGAZINE. The Foundation also employs Herbert Schneider, a chemist who is a recognized expert in quality control manufacturing to oversee the quality of melatonin (and other products).

The Foundation's Experience With Melatonin

Foundation vice-president William Faloon states that: "If people have been 'wrapping their cars around telephone poles' as a result of taking melatonin, how come we haven't heard about it? We've sold pharmaceutical-grade Melatonin to tens of thousands of satisfied customers from around the world for the past 3 years, and have never had any complaints about side effects. It's clear that Dr. Wurtman has an agenda which is not in the best interests of the American people, unless they happen to be stockholders of his company, Interneuron Pharmaceuticals. We deplore the unobjective news reporting of the NBC Nightly News."

The Gallo Raid: False Arrest Over DHEA

By John Hammell, Political Coordinator, Life Extension Foundation

On Aug. 21, 1995, Foundation member Paul Gallo and Eugene Brill were reading the paper and baking potatoes at Gallo's home in Oradell, New Jersey when the phone rang. It was a Postal Inspector requesting Mr. Gallo's presence at the Post Office "along with some identification." Gallo, a retired school teacher, who's lived in Oradell for 40 years, thought it was a call to pick up an unclaimed letter or parcel. So Brill drove Gallo, who is 75 years old, and wasn't feeling very well, to the Post Office.

After Gallo walked to the Post Office building from Brill's car in the parking lot, a stranger walked up and demanded that Brill get out. Without showing Brill any identification, the stranger demanded to see Brill's license and asked if he owned the car. Brill was very nervous. He got out of the car. The stranger said he wanted to search it. Initially Brill refused, until the man told him that, if he did not allow him to search the car, Brill would be "taken downtown for questioning."


A Terrifying Experience

Terrified, Brill complied, still totally unaware of what was happening, when five Bergen County Narcotics Strike Force police converged, snapping cuffs on him without reading him his rights. They told him there was a warrant out for his arrest (which turned out not to be true, although they did have a warrant for Gallo). The police said they were searching for a "controlled dangerous substance."

Brill then noticed Gallo being escorted out of the Post Office by police, who made the 75-year-old man sit on the curb in the parking lot in the 90 degree heat and sweltering humidity. After showing identification and signing a yellow release slip in the Post Office, Gallo had been INFOrmed that he was "under arrest".

As they snapped cuffs on Gallo, Brill asked: "How can you do this to a 75-year-old retired school teacher who has lived in the community for 40 years, has taught school here for 25, and has broken no laws?" "I'm just doing my job," was the terse reply from 22-year-old Paul Cavicchia of the Bergen County Narcotics Task Force, who led the operation. Gallo's complaint that the cuffs had been cinched too tight fell on deaf ears.

The Interrogation

Both men were interrogated for an hour about whether they had any medical conditions, whether they were taking any medications, where they had gotten their medications from, and how they had found out about the medications.

Brill told them he was a renal transplant patient who needed the drug Prednisone, for which he had a prescription. When asked if he was HIV positive, he said "no". He was then grilled about how long he'd known Gallo and how long he'd lived in his house. He told them that they'd been friends for 20 years.

Brill said that, after the three cops who'd been searching his car found nothing, they became less hostile. But when he asked to leave because he was afraid of his lit oven causing a fire, they forced him to remain seated, even though he hadn't been placed under arrest.

Brill sat there for an hour while they threw Gallo into a cell. Then he was shoved into a private
interrogation room where the Police Chief and Narcotics Chief read him his rights and grilled him about where he'd purchased offshore medications, what he had purchased, and how he had learned about the offshore companies who sell the medications. They demanded to know if he realized that "DHEA is a steroid."

The truth is that DHEA is a precursor to anabolic steroids, but is not an anabolic steroid itself, and its purchase and use is not illegal, either under New Jersey or federal law. Gallo had been falsely arrested. In actuality, DHEA is a dietary supplement as well as a prescription drug under the law. Gallo had a prescription for DHEA from Dr. Eric Braverman, a local physician.

The Intimidation

After making Gallo sit in a room for another 40 minutes, the Postal Inspector made him sign a thick sheath of forms. He was then fingerprinted and mug shots were taken. The Postal Inspector then drove him home and said angrily: "If you have anything in your house that we ought to know about, you should tell me now because we can raid your house whenever we want to." Completely intimidated, Gallo asked the Inspector to accompany him to his bedroom, where he handed him a bottle of DHEA that he had obtained with a prescription.

The Response

Gallo then called me at The Foundation's Political Office and faxed me a copy of the summons. Immediately, I called Foundation attorneys William Moore in Savannah, Georgia, Nancy Lord in Atlanta, Georgia, and Ralph Fucetola in Morristown NJ A search of the Federal Register indicated that DHEA had never been classified as a "schedule 3 controlled dangerous substance" at the federal level and a search of the New Jersey statutes indicated that it had never been so classified at the state level.

Attorney Ralph Fucetola filed a Motion to dismiss the case based upon the fact that the state did not have the authority to take this action. Fucetola moved that the case be dismissed because the state cannot prove that DHEA (a metabolite of cholesterol) is any more a "controlled dangerous substance" than cholesterol is. No action has yet been taken on this Motion.

We've not heard any reports of similar raids against DHEA users in other states. We've since learned that the Drug Enforcement Agency (DEA) had considered making DHEA a scheduled drug, but decided against it because of protests from health freedom activists. Apparently, the Customs office in Newark, the Postal Inspector, and the Bergen County Narcotics Strike Force were misINFOrmed by someone about the legal status of DHEA.

What To Do If Your Products Are Seized?

Although the kind of terrorism that struck Paul Gallo and Eugene Brill may be an isolated incident, product seizures by U.S. Customs (under direction of the FDA) of unapproved drugs ordered from overseas companies are more common. Here are our suggestions about what to do if your products are seized by customs or the FDA.

First of all...You are not in legal trouble! Do not be intimidated! Hundreds of products have being illegally detained by the FDA, not just yours. We can beat them if we work together. Please use the model letter on the right to guide you in responding to customs. Our model letter is addressed to customs in Newark NJ, where most of the product seizures have been occurring recently. If your product was seized at a different location, be sure you alter your letter by using the FDA or customs address where your product was seized. Do not reply using their forms, or you will put yourself in the following bind: either you will forfeit your right to get your shipment back, or you will disqualify yourself from participating in our class action lawsuit against the FDA by failing to exhaust your administrative remedies.

MODEL LETTER

Name: Date:

Address:

City: State: Zip:

ENF: (insert #s from their cover letter)

CN: (insert #s from their cover letter)

Area Director of Customs

Hemisphere Center

Newark NJ 07114 (or other customs address if different)

To Whom it May Concern:

I hereby exhaust my administrative remedies in the above stated matter, and demand an immediate return of my property which was never introduced into interstate commerce. The transaction occurred offshore and ownership of the products was transferred to me, the purchaser, at that time. I am the rightful owner of these products, and you have illegally stolen my property.

I have imported this product(s) for my own personal use, and not for commercial resale. I am acting in accordance with the FDA's Mail Importation Policy, and if you dispute this, the burden is on you to explain to me exactly how I am in violation of FDA rules. I have INFOrmed my physician that I am taking this product(s).

These medicines are all unapproved drugs, in as much as the FDA has not approved their use for the purpose of slowing aging. This medication is being imported to treat a life threatening medical condition and I will suffer permanent neurological and immune cell injury if you do not immediately release my property to me.

I am sending my two Senators and Congressperson copies of this letter, along with Congressman Joe Barton, Chairman of the Oversight and Investigations Subcommittee of the House Commerce Committee, which is conducting FDA oversight hearings. (The Honorable Joe Barton, Oversight and Investigations Subcommittee c/o Commerce Committee 2125 RHOB Washington DC 20515 FAX 202-225-1919, Ph.202-225-2927)

Although customs is not the FDA, you work with the FDA, and you are bound to act in accordance with the FDA's policy on personal importation of unapproved products. I will vigorously pursue the release of my property if you do not immediately release it. I contend that both customs and the FDA are engaging in illegal restraint of trade due to pressure from the pharmaceutical industry to deny my access to low cost offshore medications that compete with FDA approved drugs.

I am sending this to you via either certified mail with return receipt requested, or via fax at 201-645-6599 and am saving the activity report from the fax machine so that you cannot claim I did not send it.

enc.: Your cover letter to me Signed:

Witnessed by:

Witnessed by:

Justice Department Drops Charges Against Dr. Wright

In a September 19, 1995 letter, the U.S. Attorney's office INFOrmed counsel to Dr. Jonathan V. Wright that the Justice Department was closing its files in the matter of the United States v. Jonathan Wright. It also stated that counsel would arrange for the return of a limited number of items seized from Dr. Wright's Tahoma Clinic on May 6, 1992.

The FDA's Gestapo-like raid of Dr. Wright's clinic in June 1992 was covered on TV in Seattle, which led to extensive media coverage throughout the country. Two dozen federal and local police wearing flack jackets and carrying guns had broken into Dr. Wright's Tahoma Clinic like gangbusters. Their brutal, terroristic raid angered millions of Americans across the nation who rallied to the cause of health freedom.

The FDA had previously raided Dr. Wright a few months earlier in order to seize uncontaminated pharmaceutical-grade l-tryptophan, which Dr. Wright needed for his chemically sensitive patients, and which had been assayed for purity by the Mayo clinic following the scare caused by a contaminated batch of tryptophan.

Dr. Wright had filed a lawsuit against the FDA for return of his tryptophan. The June 23 raid was a retaliatory strike to "punish" Dr. Wright for his lawsuit. We may never learn how much time and money the FDA spent harassing Dr. Wright for his "transgressions". We do know that the FDA sent an undercover agent into his office posing as a patient. We also know that they weren't protecting us from contaminated blood, and other serious risks to the public health, while they were "protecting" us from Dr. Wright.

Since Dr. Wright is an internationally respected, Harvard-educated orthomolecular physician who lectures throughout the world, the FDA's raid on Dr. Wright's clinic was an especially egregious action. The FDA seized a truckload of patient records, injectable B vitamins, computer equipment, and other property. Later the nation watched aghast on TV as news reports of Dr. Wright's ordeal were broadcast.

The Threat Of FDA Oversight Hearings

Due to the threat posed to the FDA by the ongoing Hearings being conducted by Congressman Joe Barton's Oversight and Investigations Subcommittee, the FDA and the Justice Dept. appear to be exercising damage control by dropping their case against Dr. Wright. They want to head off a probe on the matter as well as on a host of other illegal raids against dietary supplement companies and innovative healthcare organizations (including The Life Extension Foundation, which was raided in 1987).

Although LIFE EXTENSION MAGAZINE couldn't reach Dr. Wright for comment prior to press time, Dr. Wright's press release of September 26, states that: "A nightmare of four years duration has come to an end. Justice has been served." Acting on behalf of the Justice Department and the FDA, the U.S. Attorneys office in Seattle had tried unsuccessfully to obtain a grand jury indictment against Dr. Wright. A lack of evidence and the apparent unwillingness of the grand jurors to issue an indictment stymied government efforts. Jonathan Emord, one of Dr. Wright's attorneys, commented that: "Dr. Wright is an honorable man and a talented and respected physician who suffered unnecessarily for four years. The Justice Department has done the right thing by dropping these charges."

The Foundation's View Of The Matter

We're very happy that the Justice Department has dropped their case against Dr. Wright and we hope he will be able to get everything back that was stolen from him by the FDA. We urge our members to call the House Commerce Committee at 202-225-2927 and to ask for the voice mail of Alan Slobodin, counsel to the Committee, who is coordinating the oversight hearings.

Please request that their upcoming hearings include witnesses who can attest to the FDA's illegal raids against dietary supplement companies and alternative physicians; as well as other witnesses who can testify about the FDA/Customs ongoing unconstitutional seizures of unapproved drugs imported for personal use (in
compliance with the FDA's own rules governing personal importations.)

Along with this, we encourage you to copy and sign the form letters (following this article) in support of the Access to Medical Treatment Act and the Food and Dietary Consumer INFOrmation Act and mail them to your Senators and Congresspersons. Don't mail these letters to the LEF Political Office! You can obtain the addresses of your Congressional offices from the front of your phone book under government, or by getting a copy of the U.S. Congress Handbook ($9.95 + $3.00 shipping) (add .95 for a spiral binding - it's well worth it) (Virginia residents add 4.5% sales tax). Send to:

U.S. Congress Handbook

Box 566

McLean VA 22101

This handbook is a MUST for citizen lobbyists! or call 703-356-3572

HR 1951 inserted here

The Access to Medical Treatment Act (HR 2019) inserted here