[This piece was written Saul Kent, President of the Life Extension Foundation, Hollywood, Florida, a tireless advocate for freedom of choice. This was written 2 months BEFORE the federal trial of TMI in Albuquerque, NM, as background on GH3 and the FDA].

FDA Tyranny In Action

The FDA is a terrorist organization. FDA agents do not hesitate to lie, cheat, and steal in order to destroy those who challenge their authority. They also threaten and attempt to intimidate anyone who stands between them and the targets of their wrath. The fact that the FDA is a government agency with formidable powers heightens the effects of their terrorism. The realization that a powerful arm of the federal government will stop at nothing to destroy its enemies stops most medical practitioners from exploring “unorthodox” or “alternative” healthcare options, and keeps millions of Americans who are searching for new ways to stay alive and healthy in a state of perpetual apprehension.

An Example of FDA Terrorism

Few Americans ever feel the full brunt of FDA terrorism themselves. Americans who are assaulted the FDA as “examples” of what can happen to those who deviate from the “party line” have very special stories to tell. Here is the story of one recent victim of FDA terrorism. Rodger Sless faces up to 37 months in federal prison for the alleged “crime” of selling the world-famous Romanian youth drug Gerovital-H3 (GH-3) to Americans. This is an especially interesting case because it illustrates FDA brutality at its worst, and shows how safe-and-effective drugs used throughout the world are denied to Americans the criminal FDA.

Twelve Years of Openly Selling GH-3

For 12 years, Rodger Sless had been selling Americans (through a company called Tierra Marketing) the same GH-3 that’s been used in countries throughout Europe, Asia, and South America as an anti-aging therapy ever since its discovery Dr. Ana Aslan in Romania in the 1950s. The FDA knew that Rodger, and others such as Jerome Godin in Florida, had been selling GH-3 to Americans for decades, and that the sale of GH-3 is legal in Nevada. They also knew that a surprise raid on Rodger’s company would send the unmistakable message to other companies selling alternative therapies that the FDA was prepared to destroy any of them, without notice or warning of any kind.

The Nightmare Begins

On April 8. 1993, Rodger Sless and his shipping clerk went to a mailing address to pick up a package containing GH-3. When they returned to Tierra Marketing’s offices in Albuquerque, New Mexico, they were intercepted FDA, Customs, and Post Office agents who poured out five cars, several of them pointing their guns at Rodger, his shipping clerk, and his secretary (who had been waiting in his office) and demanding that all three put their hands on their heads. Rodger and his employees were held hostage outside the facility for 45 minutes, while the federal agents began their search and seizure mission, for which they didn’t yet have a search warrant. The FDA proceeded to seize virtually all the products found in Tierra Marketing’s office, in addition to files, computers, other equipment, and personal effects. On January 20, 1994, Rodger was indicted on 15 felony courts, including “conspiracy”, “fraud”, and use of a fictitious name to conduct “unlawful business”. He is scheduled to stand trial in May of this year. On March 11, Rodger’s attorney (Richard Utman, Jr.) received a letter from attorney Gerald C. Kell of the U.S. Department of Justice (on behalf of the FDA) offering Rodger a plea bargain offer “to resolve the charges currently pending against him.”

The Government’s Offer

The government’s offer, which is only open until April 1, 1994, is as follows:

“Mr. Sless would plead guilty to Count 1 of the indictment (the conspiracy count) and to three substantive counts of his choosing. In return for Mr. Sless’s plea …the government would move, at the time of sentencing, to dismiss the remaining counts of the indictment against Mr.Sless.

“The total offense level under the proposed plea is 18 with a guidelines sentence range of 27 to 33 months. However, if Mr. Sless enters the proposed plea promptly, so that the government need not further prepare for trial and the Court need not allocate any additional resources to this matter, a reduction of the offense level to 15 could be appropriate, resulting in a guidelines sentence range of 18 to 24 months.

“If Mr. Sless determines not to enter a plea in accordance with the foregoing, the government will proceed to trial on all counts charged in the indictment. My calculation of the offense level if Mr. Sless is convicted on all counts is 19, with a corresponding guidelines sentence range of 30 to 37 months. Thus, declining to accept this plea offer, Mr. Sless will increase his possible sentence from a minimum of 18 months to a maximum of 37 months, more than doubling his potential incarceration time.”

A Travesty Of Justice

This plea bargain offer is an example of the outrageous penalties the government uses (on behalf of the FDA) to threaten dissident companies with, and the pressure it puts to bear on defendants to settle their case without having the opportunity to defend themselves in court. The deal offered to Rodger Sless is 18-24 months in prison for the “crime” of selling to Americans a product (GH-3) whose safety and effectiveness have been recognized virtually every country on Earth, including the state of Nevada in the United States, and where Rodger Sless’s customers have been satisfied with the product, and are angry with the FDA for depriving them of it.

Total Disregard For The Truth

A good example of the FDA’s utter disdain for the truth in seeking to destroy its enemies is how the agency characterized the “dangers” of GH-3 in attorney Kell’s letter to Rodger Sless’s attorney.

“The active ingredient in Gero-H3, procaine hydro-chloride, can cause, among other adverse side affects, hypertension, convulsions, tremors, respiratory difficulty and arrest, and anaphylaxis, some of all of which can lead to death. See Physician’s Desk Reference 2162 (47th ed. 1993).”

For the FDA to use the “possible” side effects of GH-3 as outlined in the Physician’s Desk Reference as “evidence” to throw Rodger Sless (or anyone else) into prison is outrageous. Everyone in the medical profession knows that the extreme possible side effects in the Physician’s Desk Reference for many listed drugs have little or nothing to do with reality. The truth is that, in tens of millions patients over several decades, there have been no clinical reports of serious acute of chronic reactions to GH-3. Since both metabolites of GH-3–PABA ( a B-complex vitamin) and DEAE–are organic compounds that are rapidly excreted from the body, GH-3 is essentially a nontoxic drug that produces few side effects. In Nevada, for example, from January 1979 to August 1980, more than 3,500,000 oral doses of GH-3 were sold, with no serious problems reported. The only known contraindication to GH-3 is hypersensitivity, which occurs only rarely, and produces only minor temporary conditions such as dizziness or lightheadedness.” The active ingredient in GH-3 (procaine hydro-chloride) is not only used in many other pharmaceuticals (such as GH-3) which have been used safely millions of patients throughout the world for decades, but also is the active ingredient in Novocaine, which is given to additional millions every year as a dental anesthetic, without serious side effects. The truth is that GH-3 is far safer than the vast majority of FDA-approved drugs, including over-the-counter drugs such as aspirin. FDA-approved drugs kill tens of thousands of Americans every year, while GH-3 kills no one! To use the “dangers” of GH-3 as “evidence” to send Rodger Sless to prison is a deliberate distortion of reality that should be considered a criminal act itself!

FDA Lies About The Efficacy Of GH-3

In attorney Kell’s letter, he remarks, in justification of the harsh penalties he proposes to impose on Rodger Sless that:

“Mr Sless marketed Gero-H3 especially for diseases and conditions related to aging, although there is no scientifically acceptable evidence that the drug is safe or effective for these indications.”

This is clearly an untrue statement in light of the vast numbers of studies in world scientific literature indicating that GH-3 is beneficial for a wide variety of conditions related to aging, including depression, arthritis, hair loss and hair graying, energy loss, loss of libido, senile dementia, and atherosclerosis, as well as a large-scale animal study (920 white rats) Dr. Aslan, in which GH-3 extended the lifespan of male animals 21.2% and females 6.7% and improved the maze-running ability of both sexes. It also doesn’t take into account the thousands of case histories put forth Dr. Aslan and other European physicians showing the GH-3 is beneficial for the conditions of aging. In rebuttal to this evidence, the FDA would argue its mission is not to seek out scientific evidence for the benefits of new drugs, but only to evaluate evidence already submitted companies seeking approval for new drugs. Even if you grant the FDA the benefit of this limitation, however, it turns out that the agency is still “lying through its teeth” when it claims there is “no scientifically acceptable evidence” that GH-3 is effective for any of the conditions of aging. To get to the truth of the matter, you have to delve into the facts surrounding an attempt to obtain FDA approval for GH-3 in the 1970s.

The Rom-Amer Story

In the late 1960’s, two Romanians, Alfred Sapse, M.D. and Manfred Mosk, Ph.D., met with Dr. Ana Aslan and associates in Bucharest and obtained exclusive rights to market GH-3 in the United States. They then formed a company in Beverly Hills, California called Rom-Amer, which they soon took public, raising several million dollars. Rom-Amer then applied for a new drug application from the FDA to sell GH-3 as an anti-depressant and began to fund studies at the U.S. universities and medical centers. As a result of Rom-Amer’s funding, several controlled double-blind studies showing that GH-3 can improve the mood and behavior of depressed patients over age 50 were published in peer-reviewed medical journals. In one such study, Dr. William W.K. Zung and associates at Duke University Medical Center found that GH-3 was significantly more effective in treating depression than either placebo or imipramine (a commonly-used, FDA-approved anti-depressant). (Zung, WWK, Gianturco, D, Pfeiffer, E, et al., Pharmacology of Depression in the Aged: Evaluation of Gerovital-H3 as an Antidepressant Drug”, Psychosomatics, 15:127-131, 1974). In another study, Drs. Cohen and Ditman reported that most patients who took the drug “felt a greater sense of well-being and relaxation, slept better at night, and many obtained some relief from depression and the discomforts of chronic inflammation or degenerative disease.” (Cohen, Sman, KS, Gerovital-H-3 in the Treatment of the Depressed Aging Patient, Psychosomatics, 14:15-19, 19744). Laboratory studies provided evidence that the biological mechanism explaining GH-3’s anti-depressant effect is the fact that it is a “weak, reversible inhibitor” of monoamine oxidase (MAO), the enzyme that degrades the vital neurotransmitters dopamine and norephinephrine in the brain and central nervous system. (MacFarlane, MD, Procaine HCI (Gerovital-H-3): A Weak, Reversible, Fully Competitive Inhibitor of Monoamine Oxidase, Federation Proceedings, 34:1-5, 1975). It is the reversibility of GH-3’s action that prevents the side effects caused other anti-depressant drugs that act as MAO inhibitors.

Why The FDA Refused To Approve GH-3

The research demonstrating that GH-3 is a safe-and-effective anti-depressant was strong and irrefutable. Yet–in spite of this evidence–the FDA refused to approve GH-3 for sale in the United States. The FDA’s failure to approve GH-3 was disastrous for Rom-Amer, which had only limited funds and was unable to raise enough money to continue funding the additional research the FDA constantly demanded from the company. With Rom-Amer on the verge of bankruptcy, the company was bought Marvin Krater, a Las Vegas businessman who had experienced great benefits from the drug. Kratter then persuaded the Nevada legislature to make GH-3 (and other procaine-based drugs) legal in Nevada. In the late 1970’s, Manfred Mosk showed Saul Kent, President of The Life Extension Foundation, documentary evidence of the real reason GH-3 was never approved the FDA. Mosk had letters from FDA officials stating that the FDA refused to approve GH-3 solely because of its notoriety as an anti-aging drug, not because it was unsafe of ineffective as an anti- depressant. In short, the FDA penalized GH-3 because of the publicity it had generated over the years as an all-purpose anti-aging drug. The FDA felt that, once GH-3 was approved in the U.S., it would be prescribed for many conditions other than depression, and refused to permit this.

FDA Bias Against Anti-Aging Drugs

One of the exhibits in our new FDA Holocaust Museum demonstrates that the FDA kills Americans through its bias against therapies to control aging. The exhibit points out that the FDA’s demand that new drugs be approved for one ( and only one) application at a time constitutes strong bias against anti-aging drugs which, definition, are certain to have multiple benefits. The FDA’s blatant bias against GH-3 shows that the FDA will not only force anti-aging drugs to undergo inappropriate and unfair testing, but will then discriminate against them even if they succeed in passing the tests!

A Terrible Crime

Not content with unfairly depriving Americans of a safe-and-effective drug (GH-3) sold over-the-counter throughout the world, the FDA has compounded its crime against he American people attempting to destroy all suppliers of GH-3, and has committed a terrible crime against Rodger Sless, whose only offense has been to try (in a small way) to undo the FDA’s suppression of GH-3. The FDA knows GH-3 is a safe-and-effective drug that should be made available to all Americans. The FDA knows its attempt to put Rodger Sless into prison is totally unjust and that its only motive in attacking Sless is to strengthen its already unbearable control over the healthcare of the American people!

Stop The FDA Before Its Too Late

How much control can we allow the FDA to have over our lives before the agency becomes an all-powerful totalitarian monster that eventually harms us all? It’s clearly time to put a stop to the madness! Its time to take direct action every time the FDA commits a criminal act!

If you’re unhappy about the FDA’s assault on Rodger Sless, call Justice Department attorney Gerald C. Kell to tell him what you think about his efforts to incarcerate Sless. Tell him that Rodger Sless is an innocent man who is being unfairly persecuted the criminal FDA! Tell him you’re mad as hell and won’t put up with such unjust acts any longer!

And don’t forget to voice your protests to the FDA on May 6, 1994. If you want to stay alive and healthy, you’d better take action to stop the FDA now, before it’s too late!