1980N-0208 - Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
FDA Comment Number : EC29
Submitter : Mr. James Sparks Date & Time: 03/01/2005 07:03:00
Organization : Mr. James Sparks
Individual Consumer
Category :
Issue Areas/Comments
GENERAL
GENERAL
20 January 1991, during Desert Storm, under orders, our company was injected with a single dose 'SECRET' Anthrax vaccine. This vaccine likely contained Squalene, an oil adjuvant, illegal in the United States for human use.
The 1970 FDA approved anthrax vaccine requires six injections at precise intervals to be effective but it was still ineffective against many strains of anthrax.
The FDA has tested and found Squalene in incremental doses in various Anthrax Vaccine lots dating back to Desert Storm, suggesting research using doubling doses to test human tolerance to Squalene.
Squalene is known to induce Multiple Sclerosis. Adjuvants also are known to induce Scleroderma. I developed Scleroderma and Multiple Sclerosis since the Anthrax Vaccine. I feel I have other underlying yet undiagnosed autoimmune diseases as well. I feel my entire body is affected with autoimmune disease as a result of Squalene laced Anthrax Vaccine injection.
BioPort disclosed ON January 31, 2002, the date on the new product insert, that recipients of anthrax vaccine reported allergic reactions and autoimmune disease as a consequence of anthrax vaccination. The product insert lists the following serious adverse events as infrequently reported by recipients of anthrax vaccine: pemphigus vulgaris, endocarditis, angiodema and other hypersensitivity reactions, idiopathic thrombocytopenia purpura, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis, inflammatory arthritis, transverse myelitis and glomerulonephritis. All are dysfunctions of the immune system or diseases that are specifically autoimmune. Other infrequently reported events include celluitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions.
The VA refuses to test for antibodies to Squalene, or fund this testing that is available. While Walter Reed has created its own antibodies to Squalene assay and filed for patent of their antibodies to Squalene assay.


This SECRET Anthrax Vaccine broke my immune tolerance, inducing multiple Lipoma within 60-90 days, Scleroderma within six months to one year, and Multiple Sclerosis symptoms within one year. I have no doubt this Multiple Sclerosis involves my brain and spinal cord, causing inflammation of my peripheral nervous system and this has evolved into irreversible central nervous system damage and chronic pain.

The VA, in their refusal to perform advanced testing has left this diagnosis to remain hidden, untreated, and prolonged personal suffering. This has violated everything I ever imagined to be American values. These past 14 years, behind my eyes, has been nothing less than torture. I suspect, as many others do, that the VA diagnostic protocol is skewed to dismiss early stages of autoimmune diseases, thus leaving everyone scratching their heads and declaring Gulf War Syndrome for so long.

I also suspect (as many others) that there is an abundance of yet undiagnosed autoimmune disease within Desert Storm and Operation Iraqi Freedom Veterans. I also understand the risk vs. benefit argument the DoD presents as well as plans to use the Anthrax Vaccine in the civilian population if needed. These arguments become moot when those responsible refuse to admit any flaws or errors in their judgments and decisions. For too long, many have needlessly suffered so a few can keep a filthy secret for monetary gain.
This Anthrax Vaccine should not be used on troops until it has been established to be safe, effective, and free of illegal adjuvants such as Squalene. All lots should be immediately tested for Squalene and any other oily adjuvants, any other contaminants, and if found contaminated be destroyed.
If true that the FDA is no longer testing Anthrax lots for Squalene or contaminants, this should be considered criminal.

Sincerely,
James M. Sparks