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Life Extension Magazine

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September 1996

The FDA Caves In

By Saul Kent, President of the Life Extension Foundation

As it turned out, our "dread" at going to trial was mild compared to the FDA's horror at facing us in court! By the end of 1995, the FDA and the U.S. Attorney's Office no longer had the stomach to fight us. In short, they figured they would lose and that the process of losing would be an extremely unpleasant experience!

But they still weren't ready to give up completely. In November 1995, the FDA asked Judge Hurley to drop every charge against us, except one. They still intended to prosecute me for "obstruction of justice"-a charge that had absolutely no merit, but had the apparent virtue of being easy to prosecute.

We then concentrated our efforts on this charge. We interviewed the witnesses the FDA planned to bring against me, and it turned out that the FDA had no case, but was holding on to this charge in the hope that I might be convicted of "something".

In February 1996-exactly 9 years after the FDA launched its brutal attack on The Life Extension Foundation-the U.S. Attorney's Office filed a motion to dismiss this final count.

It is difficult to calculate the total cost of the FDA's war against The Life Extension Foundation because the costs have been so high and so many of the them have been hidden from view.

The first and most obvious costs have been the millions of dollars spent by both sides in fighting the war. In 9 years of combat, we were forced to spend about 1.3 million dollars for legal fees, private investigator fees, expert consultant fees, and travel.

There's no telling how much the government spent on our case, but everything points to the fact that they spent much more than we did. In fact, the raids themselves (against The Foundation and Life Extension International) were extremely costly, involving months of preparation and dozens of law enforcement personnel from different agencies.

Other Enforcement Agencies

At various stages of the "investigation", almost every U.S. law enforcement agency was involved, including the Federal Bureau of Investigation (FBI), the Drug Enforcement Agency (DEA), the Justice Department and its prosecutorial arm the U.S. Attorneys Office, and the Internal Revenue Service (IRS). These costs have to be added to the large ongoing costs (salary, support staff, and expenses) of FDA agents such as Martin Katz, who worked on the case for nine long years!

The Grand Jury Investigations

Then there were the costs of carrying out the two Grand Jury Investigations, each of which lasted about 18 months. Among these costs were: funding for several government prosecutors and their staff, funding for FDA attorneys and agents, payment and transportation costs for 22 grand jurors for almost 36 months, and the huge costs of finding, interviewing, and paying for the travel expenses of a large number of witnesses from the U.S. and abroad, most of whom had absolutely nothing to tell the Grand Jury.

The Hearings

There were two major hearings on Motions we filed to get the case dismissed as well as other shorter hearings-all of which involved the time and expenses of dozens of FDA attorneys, agents, officers, and their support staff, as well as the prosecutorial costs of the U.S. Attorney's office.

Perhaps the single largest cost came from the efforts of FDA Commissioner David Kessler to avoid testifying at our Selective Prosecution hearing. Kessler was a material witness whose testimony could have provided critical evidence that the FDA was prosecuting us unfairly. Kessler ordered FDA attorneys to file numerous legal briefs on his behalf (at taxpayer expense), including an emergency appeal (flown down by private jet) to the Court of Appeals in Atlanta, which saved Kessler from having to testify at the eleventh hour.

Derailing Life Extension Research

As large as the above costs were, they were minuscule in comparison to the much larger costs of the life extension research that remained unfunded and the life extension therapies that remained undeveloped because of the FDA's war against The Foundation.

The FDA raid in February 1987 forced us to stop our PROJECT 2000 program to achieve a major breakthrough in aging by the year 2000 just as it was gaining momentum. The March 1987 issue of Life Extension Report, which was seized in the FDA raid, featured an indepth report on the life extension scientists we were funding at the time.

The Research We Were Funding

At the time of the raid, we had already donated $790,000.00 to the PROJECT 2000 Research Fund, and had awarded a total of $380,000.00 in grants to research projects conducted by eminent scientists. Among these were the following:

  1. The Effect Of Fetal Thymus Gland Extract On Immune Function and Lifespan In Mice - Roy L. Walford, M.D., UCLA Medical Center.
  2. The development of the genetically-engineered SOD Transgenic Mouse to determine whether extra superoxide dismutase can slow down the aging process - Richard Cutler, Ph.D., National Institute On Aging.
  3. The effect on aging of the Transplantation of Brain Tissue from young animals into old animals - Don Ingram, Ph.D., National Institute On Aging.
  4. The Effects Of Thymus Hormones On Aging - Allan Goldstein, Ph.D., George Washington University Medical School, Washington, D.C.
  5. The Effect Of Tryptophan Restriction On Neuroendocrine Aging- Paul Segall, Ph.D. and Paola Timiras, Ph.D., University Of California At Berkeley.
  6. Analysis Of The Chemical Responsible For The Loss Of Protein Synthesis With Advancing Age - George C. Webster, Ph.D., Florida Institute Of Technology.

The Foundation had donated the money to fund these projects and others over a period of 14 months, with the fund growing at an ever-increasing rate as The Foundation grew in size. We had every reason to believe that our funding for research would continue to accelerate indefinitely-when we were suddenly stopped cold by the FDA raid!

Time Lost

It wasn't just the money needed to fight the FDA that derailed our research program, but the enormous amount of time we spent-month after month-year after year-for nine interminable years, fighting for survival against a powerful government agency backed by the medical establishment. There is no adequate way to measure the thousands of hours we spent on this case: going through files, writing memos, doing legal research, going to conferences, reading briefs and motions, attending court hearings, speaking with expert witnesses, and preparing to testify.

The enormous time we had to spend fighting for our lives had severely detrimental effects on our business. It was extremely difficult to manage our affairs, find and develop new products and therapies, and attend to the myriad details of running an organization.

What Was Lost

It's hard to calculate how much was lost because of the FDA war against us, but it's safe to say it was a great deal. We feel that-by now-we would have been investing millions, perhaps tens of millions, or even hundreds of millions of dollars a year in breakthrough life extension research; that we would have already succeeded in achieving our PROJECT 2000 goal of a major lifespan-extending advance; and that we'd now be well on the way to our PROJECT 2020 goal of total control over aging by the year 2020.

This is an enormous loss...far greater than the mere money expended in fighting the FDA. It is a loss that will be felt by millions of people worldwide, who will die prematurely because of delays in developing the kind of breakthrough life extension therapies destined to have a revolutionary impact on human life in the 21st century!

Making Up For Lost Time

There's no point in crying over what was lost. The fact that we've emerged victorious in our war with the FDA gives us a new opportunity to make up for lost time. In the last few years, we've begun to fund research again-at our 21st Century Medicine facility in California and at other research centers around the country. You'll see more about this research in future issues.