From the July 1999 Idaho Observer:
State, federal agents wage war against Florida pharmaceutical research company
6,000 pages of grand jury evidence indicate state complicity in federal conspiracy to ruin Liquid Deprenyl Citrate inventor and give confiscated trade secrets to competitor Somerset
by The Idaho Observer
TAMPA -- After withstanding nearly a decade of what appears to be a frivolous, harrassive and abusive federally-instigated, multi-jurisdictional investigation (code named “Operation Rx”), a Florida pharmaceutical researcher and manufacturer was allowed to present evidence of state and federal agent criminal conduct to a Florida federal grand jury here May 13, 1999.
Discovery Experimental and Development, Inc. (DEDI), President James Kimball seeks grand jury indictments of several state and federal officials for “criminal obstruction of justice, criminal RICO conspiracy, violations of constitutional rights, misuse of grand juries, criminal judicial misconduct and whatever else is criminally legally applicable that a grand jury investigation would reveal,” Kimball told the grand jury.
Kimball's serious charges stem from the nine-year investigation of himself and his company for developing an effective and marketable form of the naturally-derived nutritive plant product selegiline.
“My testimony as to what happened to DEDI and myself will border on the unbelievable, but it will be the truth as I know it,” said Kimball in his opening statement.
Kimball presented nearly 6,000 pages of documents to the grand jury in support of his claims that federal prosecutors Philip Halpern and Michael Rubenstein and Food and Drug Administration (FDA) official Dennis Degan conspired with the Florida Office of Statewide Prosecution, the Florida Department of Law Enforcement (FDLE), U.S. Customs, the Internal Revenue Service and the Florida Health and Rehabilitation Service (HRS) to drive DEDI and Kimball out of business and steal DEDI trade secrets. The confiscated (stolen) trade secrets regard the development and production of DEDI's scientific breakthrough selegiline product Liquid Deprenyl Citrate (LDC).
Selegiline is a dopamine-boosting substance that is derived from the ephedra plant and has been used to treat Parkinson's and other degenerative diseases.
Kimball's summary of evidence specifically mentioned HRS (now the Department of Health) employees Jerry Hill, Gregg Jones, Deborah Orr and Attorney Robert Daniti as playing instrumental roles in the federally-directed investigation. Kimball presented 16 exhibits which indicate HRS complicity in “Operation Rx” which include the deposition of HRS Supervisor Jones and his admission that government agents agreed to violate the law and Kimball's constitutional rights prior to the raids of his personal residence and DEDI offices in early 1993.
Kimball estimates that over 100 state and federal government employees have participated in this “investigation.”
Somerset Pharmaceuticals, owned by Mylan Pharmaceutical and Watson Pharmaceuticals, produced a contaminated selegiline hydrochloride product with the brand name Eldepryl. According to Kimball, the exhibits presented to the grand jury “clearly reveal that the FDA, HRS and Somerset knew that Somerset's product selegiline hydrochloride (Eldepryl) was contaminated with methamphetamine.”
The contamination was reported in 1990 by the U.S. Pharmacological Conference, the entity used by the FDA to test products seeking FDA approval.
Further studies indicated that Eldepryl also contained other contaminants including the as yet publicly unidentified neurotoxin “Compound X.”
The grand jury was also provided with the results of the five-year Lee study, published in the New England Medical Journal in 1998, which “revealed a death rate of almost 2 to 1 with Parkinson's patients using FDA approved protocol selegiline hydrochloride with levadopa (Eldepryl) vs. Parkinson's patients using levadopa alone without selegiline hydrochloride.”
Kimball believes that the contaminants, which are not added to Eldepryl but are a condition of its manufacture, could be “washed out” but that doing so was likely considered by Somerset to be cost prohibitive. Kimball also believes that the purpose of this ongoing “investigation” was to secure DEDI trade secrets regarding the production of LDC so that they could be given illegally to a competing company, Somerset Pharmaceuticals.
Liquid Deprenyl Citrate
The healing properties of the ephedra plant have been documented for centuries.
The ephedra-derived product selegiline had never been manufactured for human use because it loses its effectiveness within an hour. Scientists had tried unsuccessfully for 30 years to “stabilize” selegiline. After five years of research, DEDI was able to stabilize selegiline with a specially formulated citra gel. In 1990, Kimball named his new experimental product Liquid Deprenyl Citrate and sent samples to the University of Toronto for test trials.
The result was a selegiline product that was more effective than any selegiline hydrochloride product ever tested “and adverse side effects were negligible or none,” said Kimball.
After researching all applicable state, federal and international commerce laws and determining that LDC could be legally manufactured, sold and used by the public, DEDI invested tremendous time and resources into constructing an international network that would manufacture and market the product worldwide.
Before LDC was even ready to market, Somerset filed complaints against DEDI with the FDA, HRS, U.S. Customs and the Department of Justice. Somerset complaints resulted in Kimball being arrested in December, 1990, for selling LDC.
The case was dismissed prior to trial for lack of evidence -- Kimball could not possibly have sold LDC because marketable LDC had not yet been produced. Kimball also believes that the case was dismissed to avoid public disclosure of illegal acts committed by government agents and law enforcement officers during the “investigation” and his subsequent arrest.
DEDI began producing and selling LDC for the Mexican marketplace in 1991. Under the alleged authority of a grand jury investigation, DEDI and Kimball's personal residence were raided by HRS. The IRS seized all bank accounts under suspicion of alleged money laundering. The U.S. Postal Service opened a mail fraud investigation.
The IRS returned the money but forced Kimball to “sign papers which agreed that I would not sue them for wrongfully confiscating my company's money,” said Kimball.
According to Kimball there was serious grand jury abuse as subpoenaed parties were simply interrogated by government agents and flown home. Kimball believes the evidence proves that copies of documents seized from his home and business, including personal information and trade secrets protected by law under the veil of a grand jury investigation, were given to HRS and Somerset by the federal prosecutor's office in San Diego.
Somerset filed suit against DEDI in 1993. The case was settled at the request of Somerset which agreed to pay DEDI and Kimball's court costs of $55,000.
“Before the ink was dry on the settlement papers, Somerset applied to the FDA for approval of a product that was almost, if not identical to our product Liquid Deprenyl Citrate,” said Kimball.
Kimball explained that DEDI immediately filed suit against Somerset for theft of trade secrets and that the suit has yet to be resolved in court. “We sued the prosecuting attorney, U.S Customs agents, IRS agents, HRS agents, FDA agents and took it all of the way through the system to the Supreme Court. We have learned that all government agents have granted themselves civil prosecutorial immunity,” commented a disgusted Kimball.
Connecting the dots
In 1995 DEDI began its investigations into the conspiracies that had forced it to be in perpetual litigation for three years and its trade secrets made available to a marketplace competitor. DEDI, under the authority of its suit against Somerset, began obtaining its immense collection of incriminating documents through the discovery process.
“We found that federal 'task force' meetings had been held before DEDI and my home were raided. At these 'federal' task force meetings, we uncovered evidence -- evidence that has been submitted to the grand jury -- that HRS officials and attorneys and FDLE agents were also in attendance. The Jones deposition and other documents describe how the raid was to be conducted for maximum efficiency,” said Kimball.
Florida state law provides that “They [government agents] must knock and announce,” before entering a business for inspection, during normal business hours, and that they must identify themselves and their intentions and that the business has the right of refusal. “After all employees had been removed from the premises by federal agents in the first wave, there wasn't anybody left to identify themselves to. In deposition, several state and federal agents admitted that they did not identify themselves nor did they announce their intention to search the business and the confiscations continued until after 7 p.m.," Kimball recalled.
“The government's plan was to get HRS and FDA agents into my home and my business unnoticed as members of the federal task force search team second wave. Once HRS and FDA agents were inside, they could all become HRS inspectors operating illegally under Florida law,” explained Kimball.
Florida law forbids HRS agents from conducting an inspection of a residence, as confirmed by an administrative court.
DEDI, with its records, research, chemicals and computer equipment seized, its mail being investigated, its bank accounts confiscated and an injunction placed against its business activities by HRS, was also forced to fight a civil action initiated by Somerset.
Curiously, the FDA, the agency that apparently instigated this total war attack on a small Florida company, filed nothing against DEDI. “They did their job well,” commented Kimball, “they conned everybody else into doing their dirty work.”
Kimball did mention that the FDA visited all of DEDI's accounts and threatened them with prosecution and legal fees if they planned to continue doing business with DEDI.
The attack waged against DEDI should be familiar to tens of thousands of Americans who have, through no fault of their own, been driven out of business by legions of bureaucrats from endless government agencies. The government obviously attempted to use the combined resources of the American people to drive DEDI out of business and failed. All suits, investigations and injunctions were dropped and the FDA didn't even send DEDI a letter of complaint.
In June, 1997, a federal court ordered the return of all items seized in the 1993 raids. According to Kimball, computers that had been under warranty when seized were returned damaged with expired warranties. “We were advised that government agencies are immune from having to pay damages. Too bad. You and I would have to pay if we damaged other peoples' goods,” said Kimball.
In apparent violation of the court order, not all items have been returned as of this writing.
Kimball filed suit against the state and federal agents. “Again, all agents are immune from damages they cause, even individually,” Kimball noted for the grand jury.
DEDI LDC not under FDA jurisdiction
As far as Kimball or the FDA has been able to determine, selegiline has never been considered a drug either legally or scientifically as rendered into law or as determined by peer reviewed literature. According to the Dietary Supplement Act of 1994, any product not deemed to be a drug prior to 1994, but identified as a supplement prior to 1994, will remain a supplement even if the product is deemed a drug after 1994. The act, according to Kimball, also allows the medical benefits of vitamins, herbs and botanicals to be stated on product labels.
According to its own laws and under the authority of the Dietary Supplement Act, the FDA has no jurisdiction over DEDI's development, production or sale of LDC because the product was deemed a supplement in 1991. Kimball told the grand jury that the FDA will probably attempt to claim that his product selegiline citrate is the same as selegiline hydrochloride (Eldepryl). “Most any person knows that sodium chloride is table salt. Sodium alone is a different entity that will kill you if you ingest it in large enough quantities. Common sense. It doesn't take a chemist to figure out that both of them are sodium,” said Kimball who added that the same thing goes for selegiline citrate and selegiline hydrochloride.
Regardless of whether or not the FDA has jurisdiction over DEDI, Kimball and the development, production and sale of LDC, Kimball has submitted hundreds of pages of documents in 87 exhibits to the grand jury which illustrate an almost decade-long FDA effort to discredit, destroy and bankrupt DEDI corporately and Kimball personally. One of the exhibits was nearly 3,000 pages of clinical trials reports for deprenyl.
According to Kimball, scientists had recognized the value of selegiline for the last 30 years and had attempted unsuccessfully to make the substance stable enough to be marketable. By 1991 DEDI had stabilized pure selegiline with a citrate gel, named the product Liquid Deprenyl Citrate and sent it out for test trials at the University of Toronto.
Available evidence shows that the FDA has been “investigating” Kimball and DEDI since 1990 due to his attempts to develop LDC for the marketplace. “Our theory was that pure selegiline, which is a different chemical entity than selegiline hydrochloride, would be more effective [in the treatment of terminal disease] as hydrochloric acid changes the chemical structure of selegiline,” explained Kimball.
“The test results came back much better than any selegiline hydrochloride they had ever tested. LDC effectiveness was far superior and adverse side effects were negligible to none,” Kimball explained to the grand jury.
According to Kimball, the federal government implied that if DEDI should even recommend to a friend how to get LDC -- even if no money exchanges hands, it would be engaging in criminal behavior. “That means we have all lost our freedom of speech, Kimball explained to the grand jurors. “If you recommend a product to friends, you are now selling it and should somewhere, sometime it be deemed that the product you recommended to your friend be illegal, you are now guilty of a crime,” he explained.
When asked by the grand jury if Kimball or DEDI had ever been sued, Kimball stated, under oath, that to this day not one consumer has ever filed a complaint from anywhere in the U.S. about the quality or performance of LDC or any other product that DEDI has ever developed or sold. To the contrary, customer comments expound upon the quality of life extending and enhancing virtues of LDC.
Of the five leading causes of preventable death as reported by Public Citizen magazine (May/June, 1994), medical malpractice was the third most frequent killer at 80,000 deaths per year, or one every seven minutes.
According to a 1985 report from the University of Southern California, published in The Journal of Clinical and Hospital Pharmacy, the FDA had approved “A list of 37 anticancer drugs with reported carcinogenicity or co-carcinogenicity...”
The December 18, 1996 edition of American Medical News reported that [FDA approved] drugs kill as many as 198,815 people each year, put 8.8 million people into the hospital and account for up to 28 percent of all hospital admissions. The same article estimated pharmaceutical companies' revenues at $182 billion annually.
In his opening statement to the grand jury, Kimball commented that statistics have been released which rate FDA approved drugs as the sixth largest killer of American citizens.
The FDA is the federal agency that has been charged with dictating what products or procedures you will be permitted to use to save your life or improve the quality of your life. The FDA has been given the authority to oversee the implementation of policies that will punish you for using products and procedures that it has forbidden -- even if they save your life or improve your quality of life.
“The FDA not only restricts your right to products and procedures that can save your life, they restrict the information that exists while wiping out any private research company such as ours so they can, as they already do, maintain control of 99 percent of the medical research and the medicinal products that are currently being developed,” said Kimball.
Kimball, who has also been in contention with the FDA over the approval of other very effective and naturally-derived remedies, including mild silver protein and trans resveratrol, believes that the “trickle down effect” of FDA policy “has directly caused the loss of life of tens of thousands of people in this country.”
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