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Immune Serum Globulin

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

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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