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- Many of the vaccines from the Gulf war of 1990
were never
- quite up to original FDA standards. But, with
the Presidential
- waiver in place allowed them to fudge all IND's
and related
- products.
-
- The ISG, IGG, and IGIV products used in the Gulf
were in
- short supply, and so the order was given to buy
up global ISG
- products to give to our troops. Not all was up
to FDA standards,
- but in truth nor was the products at home.
-
- In a conversation between myself and Cpt. Mike
Kilpatrick
- of OSAGWI, he had told me that DOD was
scouring the world
- looking Immune Serum Globulin during the Gulf
War.
-
- The key problem is that ISG is derived from
human blood
- products, and at that time Hep C screenings were
either not
- done or useless for detection. Even after
certain processing
- and separating procedures it was never sure if
the facility was
- sterile enough from one room to the next. i.e.
cross transmission
- from blood vat to serum vat.
Before the year 2000 around 17% of veterans
in VA facilities
had Hepatitis C. Literature stated that it
was probably from
things like veterans sharing needles. It's
been our belief here
at DSBR for several years that ISG was one
of the transmission
sources. Recently IGIV has been blamed for
Hep C transmission, the product was GAMMAGARD®. Those that
filed against Gammagard won their case and a limited
settlement. There
were 175 blood product recalls from 1975 to
1983, and Immunoglobulin was one of those products.
In the first FDA FOIA response, its noted that
the ISG had very
limited testing done. Its stated in these
records that testing
standards fall short. That licensing
standards of the products
were different from what went out.
The product was questionable, and DOD should
grant benefit
of the doubt to US troops that Gulf War ISG
was NOT a safe
product due to the nature of procurement and
distribution.
These 6 pages listed below are supposedly all FDA / CBER
have on Gulf War ISG:
-
Page 1
- Page 2
- Page 3
- Page 4
- Page 5
- Page 6
-
- In 2004 a FDA / CBER FOIA response was granted
on other
- blood product vaccines related to Michigan
Biologics. In
- this batch was 10 years of MB inspection
records related to
- Tetanus - Rabies - Diptheria - ISG - AHF - NSA
- and so
- on. Of particular interest is that the July
16th,1985 inspection
- of MB found 14 infractions. Each item in
itself a licensing violation that would produce a slightly different
product
- than set by there original lab testing
results.
-
- Plasma in a non-controlled environment, blood and water standing on the
floor below the pool. Employees not in
- protective garb around it. Plasma thawing in broken containers that were
not even identified a such. No surface microbial monitoring, or leak testing
of the HEPA filters. Alot of equipment had not been serviced in more than 2
years, or certified. A Quarantine shelf contained product ready for
release. The product license on out going containers had tape over it.
-
- Given the horrendous conditions the ISG was produced,
- how could any of it have been safe. Projected usual shelf
- life is 3 to 5 years refrigerated storage. Well, ISG was hard
- to come by, and kept by the CDC among others until it literally turned
yellow. Its possible this batch would have made it
- to the 1990 Gulf War veterans.
- The Michigan Biologics 1985 inspection:
- Page 1
- Page 2
- Page 3
- Page 4
- Page 5
- Page 6
- Page 7
- Page
8
- Page
9
-
If you have Hep C and received a ISG shot in the military prior
-
to 1990 - report events following your immunizations to:
VAERS at 1-800-822-7967
- FDA at (301) 827-3974
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