> << CBER Deputy Director had a two-day meeting with BioPort about
> "Anthrax
>  Vaccine"  Interesting, huh/  Can we FOIA the meeting minutes? >>
>

This is hopefully very good news.  I have been contacting Dr. Linda
Suydam, a deputy commissioner at FDA (in fact I called her today and had
Roxane Bates do likewise, as Rox has more names and contact info from
people with serious reactions) so maybe she is listening, or better yet
realizing there is much about which to be concerned.  I've also been
forwarding my complaints to Larry Halloran so they will be followed up.
Basically, I have been saying to FDA that:

1) DOD isn't following the package insert re reactions and legally needs
to (no more doses after systemic reactions),

2) That DOD has removed clinical judgement from those responsible for
administering the vaccine, and has promulgated policies (I have copies
of an ever increasing series of policies which I will be happy to share:
let me know) which tell medical practitioners when (and to whom: not
directly to FDA but through the OTSG) to report adverse events; when to
treat systemic reactions (and how) while continuing to immunize; when to
grant temporary waivers, etc.-- all areas in which DOD has no authority
to contravene the existing standards of medical practice.  Only people
with medical degrees have the legal authority to make those
determinations.  And "temporary waivers" are a concept with no basis
anywhere in medical practice.

3) That reaction rates are enormous and many are serious, and many
patients DO describe the same syndrome, whether or not FDA's limited
VAERS "costart" terms are capturing them. ( ie, There *is* commonality
of symptoms between vaccine recipients.)

4) These reactions in no way correspond to the side effect rates in the
package insert (a legal document intended to provide physicians and
patients with accurate information about the vaccine, which is used when
making a determination of whether to administer the vaccine).  The
published side effect profile came from an EARLIER VACCINE, not the
licensed vaccine, and the Surgeon General now acknowledges the systemic
rate as 5% - 35%.  This is legally unacceptable.

5) That FDA needs to investigate the serious reactions itself and not
rely on bogus reaction reports from DOD which deny the deaths and
chronic illnesses which have occurred.

6) That the VAERS system is designed *solely* to alert FDA of possible
problems.  Discovering a potential problem then necessitates that a
careful clinical trial be done to evaluate the effect, if any, and
measure its magnitude.  The fact that one in every 500 vaccine
recipients has filed a VAERS that reached FDA should be enough to
trigger such a trial.  And since a trial was started (Tripler AMC) 18
months ago, the data should be available now for FDA's review.

I did not mention, because I just learned this, that the AVIP put their
own people into the committee that evaluated the VAERS (Dr. John Sever's
expert committee).  And of course Dr. Greg Poland was the guy set up to
separately look at VAERS for the AVIP.  So how can the VAERS evaluations
be considered unbiased?

What I am afraid of is this:  to cover everyone's butts, FDA will
approve a new package insert with corrected side effect rates, except
that it claims systemic reactions are temporary and mild (though 90% of
systemic reactions were chronic, according to the recent Dover survey of
the 9th Airlift squadron) and that permits revaccination after systemic
reactions occur.  Such a change however, will not affect the fact that
the vaccine was used outside of the parameters FDA has approved in the
past.

Instead, FDA should place a temporary hold on the vaccinations, while it
evaluates the situation and obtains additional information.

Meryl Nass, MD

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