If Jay Kimball could be
accused of anything, it’s that he was too honest. He told the FDA
several times what he was doing and tried to follow their
procedures, but he ended up only giving them the ammunition to
destroy him.
James Kimball, known as
“Jay,” of Zephyrhills, Florida, developed a product in the late
1980s called Liquid Deprenyl Citrate (LDC), which showed success not
only with cancer but with Parkinson’s and Alzheimer’s. It
stimulates production of a brain chemical that becomes depleted with
age and is necessary for proper immune functioning.
Kimball first contacted
the FDA in 1990. A version of the product he wanted to create was
being imported from Hungary and sold by a small company, Somerset
Pharmaceuticals, owned by two larger pharmaceutical companies.
Kimball pointed out that
Somerset’s version had contaminants “detrimental to the actions
of the product” and also wanted to know why the FDA restricted
information indicating that the product worked for Alzheimer’s.
Kimball said, on a (now-defunct) web site about his case, “The FDA threatened me with
serious repercussions if Discovery [his company] made public any
statement regarding any use of deprenyl not authorized by the
FDA.”
Kimball applied to the
FDA several times for approval for his product, and his applications
were “lost,” ignored, or denied. He finally set up a company in
Mexico to make LDC, which was then imported. He also set up a
company in Florida, Discovery Experimental and Development, Inc. (DEDI), to make other dietary supplement products.
His motive, according to
a “Declaration” on his web site, was not financial. He was
already fairly well off when he started DEDI, and he took no
remuneration. He also says, “The majority of people, companies and
universities that assisted DEDI and GHI/MRI did so to help develop
products to help humanity and without payment for their services.”
The government raided
DEDI not once but three times (1990, 1993, and 1999). After the
first raid, it took nine grand juries for the government to indict
Kimball. His wife, Josephine, says that at the last one, “the only
reason they indicted him, they never saw actual testimony. The
prosecutor and the federal agents and state agents were actually
playacting in front of the grand jury, where the jurors couldn’t
ask any questions of the witness — because they [the witnesses]
weren’t there.” The transcripts, she says, had statements such
as, “Well, you read this part as if you were agent W. Smith, and
I’ll read this part.”
The 1993 raid involved
“the FDA, IRS, California Drug Enforcement, FDLE [Florida
Department of Law Enforcement], U.S. Postal Service, U.S. Customs,
the Florida HRS Pharmacy Services and others under a federal warrant
issued to U.S. Customs in Tampa, Florida.” In addition to business
and personal items, they confiscated files containing Kimball’s
proprietary information — trade secrets on the synthesis of deprenyl
and other products, the identities of customers, FDA application
filings, as well as personal records and books, and documents from
unrelated companies — to which his competitor, Somerset
Pharmaceutical, was later given access. Agents even raided his
daughter’s apartment in California, breaking down the door.
Somerset’s interest in
eliminating DEDI as competition becomes clear from the economics of
the drug. Their product sold for $120–150 for thirty 5-milligram
tablets. Kimball estimates their manufacturing cost to have been
less than a dollar. His own product sold for $75 for twice as much,
300 milligrams.
Kimball represented
himself at his criminal trial in 2000, because he couldn’t afford
a lawyer, and the judge refused to appoint one. The judge contended
that Jo Kimball should sell their house, which Jay wouldn’t let
her do. Kimball also thought, based on what the prosecutor had told
the judge, that the maximum sentence would be three years. He got
thirteen years, of which he’s done four.
The judge added ten
years to the expected three, Jo says, because he “was so furious
with Jay because he didn’t have an attorney and things didn’t go
the way they should have during the trial.” The additional time
was nominally for a “charge of fraud against the FDA — because
they couldn’t find anybody he committed fraud against, couldn’t
find anybody he stole money from, couldn’t find anybody to
complain, so they said he defrauded the FDA.” For various reasons
not limited to this case, the Kimballs believe payoffs were
involved. As Jo points out, thirteen years for mislabeling a dietary
supplement (the purported offense) is unheard of.
The web site has
extensive documentation of Kimball’s decade-long battle, including
betrayal by various government and industry people and appalling
allegations of prosecutorial and judical misconduct. A hit counter
on a previous version of the site indicated that it had been accessed
more than 1.8 million times. According to the site, Jo receives
“continuous calls from LDC users crying on the telephone, either
dying or degenerating” because they can’t obtain the product.
Even after his
conviction, Kimball’s problems didn’t end. The judge had
requested that he be kept close to home, and at first he was at
Coleman Low in Florida, a minimum-security institution. The attorney
for Kimball’s businesses says in a letter, “There is also no
question in my mind that Jay is being retaliated against by the
officials at Coleman,” and he details several instances of that
retaliation.
After the 9/11 attacks,
Jo learned that prison guards had been abusive toward Middle Eastern
inmates. She learned this because the inmates’ wives told her, in
the visiting room. She sent emails to some U.S. senators, and the
subsequent inquiry resulted in the warden’s transfer — upstairs.
He became an assistant to the regional director in Atlanta. Kimball
was subsequently transferred, on a pretext, to Yazoo City,
Mississippi, seven hundred miles from home.
Kimball points out on
his web site that Yazoo City is unofficially considered a
“punishment prison” (although retaliation is contrary to Board
of Prisons regulations): “The BOP classifies Yazoo Prison as a
Disciplinary/Punishment Low Security Prison; although not
publicly.”
Kimball has repeatedly
requested a transfer from Yazoo City to a minimum-security prison
camp in Florida, nearer his home. The request has been approved at
the local level but is repeatedly denied at the regional level,
apparently by R. E. Holt, the regional director.
Holt was a friend of the
former warden at Coleman and gave him a job in Atlanta, working
under Holt, after the warden’s removal from Coleman. Kimball’s
transfer to Yazoo City occurred subsequent to this incident and was
apparently a result of it. The warden is now deceased, but Holt’s
vindictiveness lingers on to prevent Kimball from transferring back
to Florida.
Update
(2011): In
June 2005, Jay Kimball was transferred to a minimum-security
camp. In December of that year, he escaped. In April 2009,
federal marshals found him living with his wife and son in a
trailer park in Florida and recaptured him. His legal expenses
had resulted in the loss of the Kimballs' home and a building
that housed their businesses. At the end of 2010, Kimball's
wife, Josephine, died after a long illness exacerbated by
despair at his lengthy imprisonment.
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