Top One Hundred Countdown -- Anthrax Vaccine Quotes - #96

[Guest guest]

DoD press briefing when the AVIP was announced, 15 Dec 1997 -- " problems

found were not in the anthrax production line " :

On the day the AVIP policy was announced a general or flag officer who

declined to be named made the following false statement about the FDA's March

1997 Notice of Intent to Revoke the anthrax vaccine manufacturer's license:

" Last spring the Food and Drug Administration notified the producer of the

vaccine -- the Michigan Biological Laboratory -- that they had some

production problems with regard to quality assurance and production practices

and they needed to fix these. Those were identified, a management plan was

put in place, we worked closely with the lab to do that. The problems found

were not in the anthrax production line, they were in other areas of other

products being produced in the lab. " (See:

http://www.defenselink.mil/news/Dec1997/x12181997_x1215mfp.html)

DoD press briefing, 5 Aug 1999 -- another anonymous general made the

following statement:

" The first [issue] that's sort of hanging in the background and I think needs

a direct answer is the FDA having to shut the plant down for renovations.

That's another one of those urban legends or something that just keeps

cropping up. We planned to shut the plant down to modernize it... " ( See:

http://www.defenselink.mil/news/Aug1999/x08051999_x0805ant.htm)

Fact: The statements above infer the closure of the anthrax vaccine

manufacturing facility was due to " renovations " , rather than the real reason

-- multiple failures of FDA inspections leading to the FDA to conclude in a

20 Feb 1998 report finding: " The anthrax vaccine manufacturing process is not

validated. "

Major L. " Buzz " Rempfer