From the July 1999 Idaho Observer:
Florida Grand jury hears murder tale
FDA, DOJ, Somerset aware of contaminated Eldepryl
TAMPA -- A Florida federal grand jury heard testimony and received in evidence hundreds of pages of documents May 13, 1999, which indicate that the Food and Drug Administration (FDA) and the U.S. Department of Justice (DOJ) and the Florida Department of Health and Rehabilitation Services (HRS) permitted Somerset Pharmaceuticals to manufacture and sell to the public its contaminated selegiline hydrochloride product Eldepryl.
We tested the FDA-approved Eldepryl in 1990 and found that it was contaminated with, among other things, methamphetamine. We also isolated a suspected unidentified neurotoxin contaminant (Compound X), said Discovery Experimental and Development, Inc. (DEDI), President James Kimball, 59.
Federal law requires that any product containing a controlled substance be registered with the Drug Enforcement Agency (DEA). According to Kimball's grand jury testimony and exhibits #10 and #20, it is clear that the FDA, HRS and Somerset knew that Somerset's product selegiline hydrochloride (Eldepryl) was contaminated with methamphetamine.
The U.S Pharmacological Conference, the entity that the FDA relies upon to test products for approval, learned in 1990 that Eldepryl was contaminated with a controlled substance, claims Kimball who contacted all of the parties involved and feels that news of contaminated Eldepryl fell on deaf ears.
Annetta Freeman of Los Angeles was diagnosed with Parkinson's in 1990 and was prescibed Eldepryl by her doctor. I was taking 5 mg. [of Eldepryl] per day for awhile and when my dosage was increased to 10 mg., I began to feel as if I were being stabbed in the stomach with a knife, Freeman said. After about a year of taking Eldepryl, Freeman, now 62, could barely even get out of bed.
Almost immediately after discontinuing the use of Eldepryl, the stomach pains stopped. Freeman began treating her Parkinson's with another selegiline product, Liquid Deprenyl Citrate, and her Parkinson's symptomology has almost totally disappeard, she said.
News of Freeman's miraculous recovery has traveled around the world and she gets thousands of phone calls from people all over and has become a popular speaker among Parkinson's groups throughout the LA area. Since becoming an advocate for Parkinson's victims, Freeman has accumulated the stories of hundreds of people who have been damaged by Eldepryl. Several people have contacted me and said that somebody they know with Parkinson's seemed to be fine one week and dropped dead for no apparent reason the following week. The only common denominator between them all was [the use of] Eldepryl, Freeman explained.
The grand jury was also provided with the results of the five-year Lee study, published in the December 16, 1995 edition of the British Medical Journal, which revealed a death rate of almost 2 to 1 with Parkinson's patients using FDA approved protocol selegeline hydrochloride with levadopa (Eldepryl) vs. Parkinson's patients using levadopa [manufactured by DuPont and marketed under trade name Sinamet] alone without selegeline hydrochloride.
Eldepryl was misbranded by law, unlawfully unregistered with the DEA, making the product illegally imported, distributed and sold to the public. The FDA and its agents, the HRS and its agents and Somerset and its employees all conspired in 1990 to conceal these violations of federal law from public knowledge. They did this with the full knowledge that the contaminants within Eldepryl could, and more than likelly would, injure the unsuspecting public already afflicted with a debilitating and deadly disease [such as] Parkinson's, Kimball wrote in his four-page summary of evidence that was submitted to the grand jury.
Selegiline, a natural, nutritive product derived from the ephedra plant, stimulates the system to produce dopamine. Younger people produce dopamine in quantities that provide for good health, mental alertness and youthful exuberance. Selegiline made properly enhances the quality of life in older people by working with the body rather than circumventing it to produce youthful and regenerative amounts of dopamine, said Kimball.
Kimball firmly believes that the contaminated Eldepryl manufactured by Somerset and sold to the public, particularly between 1989 and 1994, may have been responsible for the deaths of thousands of people.