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Court Challenges Treatment

  • A Federal court has ruled that the creator of a relatively inexpensive, non-toxic treatment for neurological disorders violated the law by making his therapy available to those who desperately need it.
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By Don Harkins

Jay Kimball of Tampa Bay, Fla.-based Discovery Experimental & Development, Inc., was found guilty of misbranding and fraud in Florida Federal Court May 24.

Kimball has been the target of Food and Drug Administration (FDA)-led persecution since he and his small Florida pharmaceutical company perfected Li quid Deprenyl Citrate (LDC) in 1990.

A jury, weighted down by the judge's instructions and apparently impressed by the Department of Justice's (DOJ) determination to gain Kimball's conviction even in the absence of evidence and intent, determined that he misbranded LDC because the label claims that it can be used to benefit Parkinson's disease victims.

The jury also found Kimball guilty of defrauding the federal government amid DOJ claims that Kimball employed fraudulent methods to continue marketing LDC even though he must have known that doing so would make the FDA very unhappy.

LDC is a nutritive plant product that is derived from the ephedra plant. After thousands of applications over 10 years, LDC has never been reported to cause an adverse reaction and only helps the people who use it.

"The product was not mislabeled as we can prove that it does exactly what we said on the label and we didn't defraud anybody, they [the FDA] knew where we were, we kept normal business hours, we had nothing to hide," commented Kim ball.

Mislabeling alone, according to Kim ball, would have been a misdemeanor. The federal government had to charge Kimball with fraud in order to justify its litigation and its desire to throw the innovative developer in prison.

Kimball, who handled his own defense in this proceeding, will file a "directed verdict" in an attempt to overturn the jury's decision for lack of evidence. Kimball is not optimistic that federal Judge Richard Lazzara will overturn the jury's verdict. In the event that the conviction stands, Kimball is scheduled to be sentenced this August. He faces a minimum of three years in a federal penitentiary.

Kimball is expected to appeal.

"They [U.S. Attorneys Michael Ruben stein and Jennifer Jones, both of whom have made a career out of persecuting Kimball] did not prove intent to violate the law and all evidence proved beyond doubt that LDC, by the FDA's own definition, is not a prescription drug within its jurisdiction as it is non-toxic and is not dangerous to use," Kimball explained.

The FDA claims that LDC is just like the FDA-approved drug Eldepryl, which is selegeline hydrochloride and has a much different atomic weight. Kimball tried to illustrate the difference between LDC and Eldepryl with the example that fresh water and salt water are both water, but that salt water taken internally can be deadly.

FDA-approved Eldepryl, selegeline stabilized with hydrochloride, has been found to be contaminated with methamphetamine and a publicly unidentified neurotoxin. Its adverse reactions, as published in the Physician's Desk Reference, include nausea, hallucinations, confusion, depression, loss of balance, insomnia, hypertension and angina. Former Eldepryl user Annetta Freeman believes that the list of Eldepryl's adverse effects include death.

LDC, which is selegeline stabilized with a natural citra gel, has never produced one reported adverse reaction in thousands of applications.

According to FDA Office of Criminal In vestigations spokesman Don Liggett, the FDA's 10-year, multi-million-dollar per secution of Jay Kimball is purely administrative. Liggett admits that the FDA has never received one complaint over LDC, nor is the FDA aware of LDC ever causing an adverse reaction.

The FDA can determine whether or not it has the authority to regulate a product based upon the intent of the user, not the product itself. In other words, if you drink carrot juice because it tastes good, it is not a drug. But, if you drink carrot juice because you believe it cures cancer, carrot juice, according to the logic of the FDA, is a drug to be placed under its regulatory authority.