Subject: [Anthrax-no] Commentary on ASG Blanck's Op-Ed
Date: Wed, 17 Feb 1999 21:11:45 -0400
From: Meryl Nass <mnass@igc.apc.org>
Reply-To: Anthrax-no@onelist.com
To: "Anthrax-no@onelist.com" <Anthrax-no@onelist.com>, mnass@igc.apc.org
From: Meryl Nass <mnass@igc.apc.org>
--Gretchen Whitney invited me to comment on the article below and I've
done so. Hope no one finds my remarks offensive. I do invite a public
debate on these issues to try and dispel any misinformation that may be
reaching the public.
--My paragraphs will begin like this --
Meryl Nass, MD
Ignore The Paranoiacs; The Vaccine Is Safe (Army Times)
By Lt. Gen. Ronald R. Blanck
In January, I had the opportunity to set the record straight and discuss
Defense Department's anthrax vaccination program with
two prominent critics on the Internet talk show Defense Watch, whose
host is a
Seattle newspaper reporter.
The other guests on the show were misinformed in at least three areas:
* They thought the vaccine had never been used before. The fact is, it's
been
in use for many years by civilian and military
agencies to protect people whose work exposes them to natural anthrax.
Thousands of people have been vaccinated with no
major problems. This vaccine has been licensed by the Food and Drug
Administration since 1970.
--Civilian agencies? Civilian researchers with DOD contracts, yes.
Have not heard of such agencies using it and I'd like confirmation from
DOD on this. No major problems? No one ever performed active
surveillance of vaccinees.
* They believed we had no evidence on the effectiveness of the vaccine
against
anthrax that is inhaled, which is the most likely
form of contact with anthrax used in a biological weapon. In fact, there
are
many studies that show the vaccine is effective
against inhalation anthrax.
--Animal studies show some effectiveness against inhaled anthrax, and
against injected anthrax. Here's the data from (the only) three
PEER-REVIEWED DOD articles, in guinea pigs faced with inhaled anthrax
spores:
1. Ivins 1986 Vollum 1B anthrax (not very virulent) 71% survival
2. Ivins 1988 Vollum 1B
67% survival
3. Ivins 1995 Ames anthrax (more virulent) 25% survival
* They also thought the FDA had questioned the quality of the vaccine
production facility and that some of the vaccine we used
was outdated.
--Notice, he doesn't deny the fact the vaccine was outdated. I am
starting to wonder if this whole program came when it did so that lots
could be used before expiring for the second time, and presumably being
"lost" after that.
Again, the fact is FDA has certified the quality of all
the vaccine produced.
--Let me quote FDA's letter to MBPI, April 7, 1998. Note the sentence
discussing quality:
"...a lot of work remains to correct the deficiencies related to the
manufacture of the anthrax and the experimental botulinum toxoid
vaccine...FDA believes that MBPI must make every effort to expedite
changes and improvements to its vaccine manufacturing facility and
correct the inspectional findings related to MBPI's manufacture of the
anthrax and experimental botulinum toxoid vaccines... The quality of the
manufacturing facility impacts the final quality of the product. It is,
therefore, critically important that MBPI meet the requirements and
applicable standards in your license as soon as possible for the future
manufacturing of these products. Significant improvements are not only
in the interest of MBPI, but also affect our ability to protect the
public health and DOD's ability to protect military personnel...At this
time the agency believes that it is necessary to impress upon you the
importance of manufacturing the anthrax and the experimental botulinum
toxoid vaccines in compliance with good manufacturing practice..."
(signed) John M. Taylor III, Senior Advisor for Regulatory Operations,
FDA
--The following are excerpts from another FDA letter to MBPI dated April
28, 1998:
"...Our review focused on the eleven lots [each lot is about 200,000
doses-- Nass] of anthrax vaccine that were voluntarily quarantined by
MBPI as a result of your telephone conversation with FDA on or about
February 27, 1998. During that conversation, the FDA raised concerns
about inspectional issues related to potency testing, sterility testing,
and the presence of particulates in a number of lots of anthrax
vaccine...
"With regard to lots FAV029, FAV032 and FAV035, of anthrax vaccine
quarantined due to concerns related to sterility testing, please submit
a detailed record of your investigations, sterility testing protocols
and the results of all additional analyses performed."
(signed) Kathryn Zoon, PhD Director, CBER, FDA
Every batch of vaccine used by the
military is tested and approved by the Defense Department and the FDA.
--No, they were tested by MBPI only, with data provided to DOD and
possibly to FDA (see above).
The deficiencies identified at the production facility were with record-
keeping, and these are being corrected.
--Read the inspection report, the letters to MBPI from FDA in 1995, 1997
and 1998 and judge for yourself if record-keeping was the only problem.
Army Times recently commented that "the services have seemed to do
little to
try to quell the fears of the dissenter." On the
contrary, there has been an unprecedented effort to inform service
members and
their families through briefings, brochures,
newspaper articles, the Internet and other media.
Still, the truth has to compete with suspicion, fear and paranoia.
--Precisely my point. The truth, found in the peer-reviewed medical
literature and other relevant government documents, must compete with
half truths and paranoia from DOD. What are DOD and General Blanck
afraid of? That someone will find out they made a mistake, took a
decision too quickly and without enough deliberation? The rest of the
world admits it makes mistakes. They are not vaccinating in Canada and
the UK now. Let's stop, rethink, review and avoid another medical
misadventure.
This
is not
unlike stories circulating that minorities' right to vote
is about to be taken away, or that travelers are in danger of being
drugged
and having their kidneys stolen for transplants. pull
quote?
--Excuse me?
Some people prefer to believe that their government is deliberately
making
service members sick.
Service members and their families need to know that the anthrax vaccine
is
safe and is a necessary protection against a
probable threat.
--And again: there are no long term safety studies, and a large body of
circumstantial evidence exists that suggests there are serious safety
concerns.
--Even if the vaccine were 100% effective AND safe, it would only invite
an aggressor to pick another weapon. EVERY nation or group that has
developed offensive bioweapons has produced more than one kind, and
generally has had several against which NO vaccine or prophylaxis
exists. DARPA recently listed 65 biological and toxin warfare agents
that can be used against humans, without including genetically
engineered strains [excerpted from Dando, 1994]. There exist effective
vaccines for less than ten.
The American people need to know that what we are doing is right. To
ensure
the proliferation of this message, we all have to
be sources of accurate information.
Everyone needs to know the facts. I have asked our medical experts to
correct
inaccurate media reports.
One of our greatest sources of information is the Internet. But it also
is a
source of misinformation about the anthrax vaccination
program. Anyone can create a Web site and post anything on it, without
verification and often without evidence.
Rumors and myths can spread through bulletin boards and chat rooms
without any
controls.
--Dr. Blanck, I believe I've cited ten sources for my information to
every one of yours. I will be happy to discuss this issue with you in
any forum of your choosing. The myths need to be dispelled. The data
needs to be presented.
The best and most accurate information is available at
www.armymedicine.army.mil and www.defenselink.mil.
I use them
--maybe that's the problem?
and I urge everyone interested in national defense to use
these
sites.
Lt. Gen. Ronald R. Blanck is surgeon general of the Army.
Baton Rouge Advocate
February 10, 1999
--
Meryl Nass, M.D.
Parkview Hospital, Brunswick, Maine 04011
email mnass@igc.apc.org
phone (207) 865-0875
fax (207) 865-6975
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