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Date:
Sat, 18 Dec 1999 22:08:07 -0500
From:
Meryl Nass <mnass@anthraxvaccine.org>
The following is very long but definitely worth looking over. My
sometimes snide comments were written in the wee hours, and I hope are
not off-putting. They are in capital letters.
There is a discussion of the number of AVA doses available and the
various stages of approval those doses fall into.
The briefers (Sue Bailey and Dave Oliver) acknowledge that the President
and Secretary of Defense might decide to use vaccine that FDA has not
approved for release, and they imply this would occur through the use of
Executive Order 13139. This is eye-opening, as it indicates that the
desire to use vaccine on servicemembers which has failed testing was
probably one of the reasons the Executive Order was brought forward on
September 30, 1999.
I believe this is worse than using experimental drugs on troops without
informed consent. This would be using drugs that FDA has reviewed and
made a decision about; FDA has deemed these lots unfit for use because
of safety concerns.
Gen. West acknowledges the past transfer of vaccine to Canada, Denmark,
Australia and Argentina, and the number of doses sold. One can assume
that most of this was used on troops in the Gulf War and might explain
some of the GWS acknowledged to exist in troops from Canada, Australia
and Denmark.
I believe that Congress should have GAO investigate the VAERS reports on
anthrax vaccine. Dr. Bailey acknowledges 559 have been filed, but then
denies they connote serious reactions or chronic problems. The simple
fact that a VAERS has been filed for every 700 vaccine recipients in the
past 20 months is itself highly significant. These reactions need to be
evaluated by independent researchers ASAP.
Furthermore, DOD again asserts that they don't have to follow the
approved 6 dose initial regimen. FDA should be cognizant of this.
Finally, they say they have vaccine from as early as 1985. That means
we can test lots that were used at the time of the Gulf War.
Meryl Nass, MD
DoD News Briefing
Monday, December 13, 1999 - 1:30 p.m. EST
Presenter: Kenneth H. Bacon, ASD(PA)
Briefing on the Anthrax Vaccination and
Immunization Program
Also Participating: Dr. Sue Bailey, Assistant
Secretary of Defense for Health Affairs; Mr.
David Oliver, Principal Deputy Under Secretary of
Defense for Acquisition, Technology and
Logistics; and Maj Gen Randall L. West, USMC,
Special Advisor to the Under Secretary of
Defense of Personnel and Readiness on Anthrax and
Biological Defense Matters.
Mr. Bacon: Good afternoon.
Charlie, I know you're astonished that we're
actually starting on time, but we are.
The topic of the briefing this afternoon is an
update on the anthrax vaccination program. We
have three people: first, Dr. Sue Bailey, who's
the assistant secretary of Defense for Health
Affairs; second, David Oliver, who's the
principal deputy undersecretary of Defense for
Acquisition, Technology and Logistics; and third,
Major General Randall L. West of the
Marine Corps, who's a special adviser to
Undersecretary Rudy de Leon on anthrax and
biological defense matters.
After they have finished making the presentation
on the anthrax update and taking your
questions, I have an announcement on another
topic. But we'll save that until the end of the
anthrax briefing.
Sue?
Dr. Bailey: Good afternoon.
Two years ago, acting on the recommendations of
the chairman and the Joint Chiefs of Staff,
Secretary Cohen approved a program to vaccinate
all active and Reserve members against
anthrax.
Nothing the department has learned in the last
two years has reduced our concern about the
threat of a possible anthrax attack against our
troops. Indeed, we know that Iraq and other
potential adversaries have weaponized anthrax so
that it can be used on the battlefield. As a
result, military commanders consider vaccination
against anthrax a necessary element of
force protection as we prepare for the threats of
the 21st century.
Last year we started vaccinating military
personnel who are deploying to two high-threat
areas, Korea and the Gulf. So far we have
vaccinated 383,000 soldiers, airmen, sailors and
Marines. This is the first phase of the program.
From the beginning, the safety of the vaccine has
been a paramount consideration. Before we
started the first vaccinations, Secretary Cohen
ordered supplemental testing of the vaccine
and a review of all the health and medical
aspects of the program by a former dean of the
Yale Medical School.
GERARD BURROW, THE FORMER DEAN, ADMITTED IN WRITTEN TESTIMONY TO
CONGRESSMAN SHAYS’ SUBCOMMITTEE HEARING ON 4/29/99 THAT HE WAS NOT AN
EXPERT IN ANTHRAX AND PROVIDED ONLY GENERAL OVERSIGHT OF THE PROGRAM
(AND DIDI NOT BLESS "ALL THE HEALTH AND MEDICAL ASPECTS".
SUPPLEMENTAL TESTING WAS A COMPLETE FAILURE, DEMONSTRATING THAT THE
TESTING PROGRAM UNDER WHICH LOTS WERE ORIGINALLY APPROVED BY THE FDA WAS
IRREPARABLY FLAWED. DESPITE ATTEMPTS TO IMPROVE THE MANUFACTURE AND
TESTING OF ANTHRAX VACCINE, FDA PROVIDED A SCATHING REVIEW OF THE
MANUFACTURER IN ITS INSPECTION REPORT OF 11/23/99.
The vaccine is safe and very effective. Secretary Cohen and Chairman
Shelton both completed the vaccination program.
The vaccine has very few side effects, and
they are mild, and they are temporary.
READ CONGRESSIONAL TESTIMONY OF MANY ILL SERVICEMEMBERS, OR REVIEW THE
540 VAERS FILED IN THE LAST TWO YEARS FOR THIS VACCINE.
When the program began, all of the nation's
anthrax vaccine was made in a small single plant
owned by the state of Michigan. We realized that
this plant would not be able to meet the
military needs. A private company, Bioport,
purchased the plant from the state of Michigan.
It tore down the old production line and built a
larger more modern production facility.
That production facility is currently being
certified by the Food and Drug Administration.
The certification process for a new production
facility is long and complicated.
ONE WOULD EXPECT A NEW FACILITY TO DO A LITTLE BETTER AT MEETING FDA’S
ROUTINE VACCINE MANUFACTURING REQUIREMENTS. THE CURRENT INSPECTION
REPORT LOOKS ALMOST IDENTICAL TO THE DREADFUL REPORT FROM 2/98.
The FDA is
applying state-of-the-art certification and
standards for all vaccine makers.
We currently have enough vaccine to continue
phase one of the program, the vaccination for
all those troops deploying to the high- threat
areas of the Gulf and Korea. We had hoped to
begin the broader phase-two vaccinations earlier
next year.
However, Secretary Cohen directed that phase two
not start until Bioport had achieved
assured production of this new vaccine.
THE PLANT HAS BEEN PRODUCING SINCE MAY. BUT FDA IS RIGHTFULLY UNHAPPY
WITH BOTH THE METHODOLOGY OF PRODUCTION AND THE PRODUCT ITSELF; MANY
LOTS AND SUBLOTS HAVE FAILED ROUTINE TESTING.
The plant has not yet begun such production, and we
will not launch phase two vaccinations until we
and the FDA are completely satisfied that the
Bioport plant meets the highest possible safety
standards.
BUT YOU ARE VACCINATING IN PHASE ONE WITH VACCINE THAT WAS PRODUCED
WHILE ALMOST IDENTICAL CONDITIONS PREVAILED AT THE OLDER PLANT. THE
ONLY REASON THAT VACCINE RECEIVED FDA APPROVAL WAS THAT THE DATA
PROVIDED TO FDA BY THE MANUFACTURER LOOKED GREAT--AND FDA DID NOT VERIFY
THE RESULTS BY TESTING PRODUCT INDEPENDENTLY OR BY INSPECTING THE
ANTHRAX PLANT BETWEEN 1991 AND 2/1998. AS SOON AS ANYONE TOOK A CLOSER
LOOK: MITRETEK, FDA, AND SAIC, IT BECAME OBVIOUS THAT THE DATA SUPPLIED
TO FDA COULD NOT BE DUPLICATED.
FURTHERMORE, DR. BAILEY, YOUR GROUP AT DOD AND BIOPORT HAVE WORKED
UNCEASINGLY TO FIND WAYS OF USING VACCINE THAT HAS FAILED INITIAL
TESTING. DO YOU RECALL TAKING AN OATH TO "FIRST DO NO HARM?"
It is difficult to estimate precisely
how long that this will take, but it could be in
the range of six to 12 months.
The Anthrax Vaccination Program is a necessary
part of our obligation to protect U.S.
forces. It's important that all military
personnel have complete confidence in the safety of this
vaccine. This is not a question of if we will
have confidence; it is a question of when we will
have confidence, given the time it takes to
certify this new plant.
HAS DOD RUN OUT OF CATCH PHRASES FOR THE BIOWARFARE DEFENSE PROGRAM? IT
USED TO BE THAT "IT WAS NOT A QUESTION OF IF ANTHRAX WILL BE USED, BUT
WHEN."
REASONS NOT TO HAVE CONFIDENCE IN THE SAFETY OF THE VACCINE INCLUDE
INADEQUATE AMOUNTS OF PRESERVATIVES (ALLOWING FOR POTENTIAL
CONTAMINATION BY LIVE MICROORGANISMS), CONTINUING FAILURE OF POTENCY
TESTS AND LACK OF VALIDATION OF STERILIZATION PROCEDURES, DOCUMENTED IN
THIS RECENT INSPECTION.
THIS INSPECTION REPORT BEGINS, LIKE THAT FROM 2/98, WITH THE STATEMENT,
"THE MANUFACTURING PROCESS FOR THE PRODUCTION OF ANTHRAX VACCINE
ADSORBED IS NOT VALIDATED."
Frankly, it has been more difficult than the
department and Bioport expected to move from a
small state-regulated production facility to a
large, modern production facility that meets the
state-of-the-art FDA requirements. Bioport has
recently beefed up its management and
production teams. At the same time, the
department has augmented the team that supervises
this program.
Let me review where we stand. We will continue
with the highly successful program to
vaccinate troops as they deploy to the Gulf or
Korea. At any given time, we have about
23,000 soldiers, sailors, airmen and Marines in
the Gulf and about 37,000 troops in Korea.
And of course, troops rotate in and out on a
regular basis. We will not begin phase two and
phase three until the FDA completes its
certification and Secretary Cohen is confident that
Bioport meets the highest possible standards.
Phase two covers early deploying troops to
high-threat areas. Phase three covers all other
active and Reserve forces.
This program is safe, effective and necessary.
And we will continue to meet the highest
possible standards.
Thank you.
I will now be joined, as well, by General West
and Secretary Oliver.
Q: Might I ask? You are saying you have so far
inoculated -- is it 383,000?
Dr. Bailey: Three hundred and eighty-three
thousand.
Q: Well, are those all in the Gulf -- were those
all rotated in and out of the Gulf and Korea,
or elsewhere also?
Dr. Bailey: These are those who either have
deployed or will be deploying.
Q: So the Gulf and Korea, but not elsewhere?
Dr. Bailey: Yes.
Q: That's the whole course of six --
Dr. Bailey: They have begun. They may not have
completed all six.
Q: How many troops are in the second phase?
Dr. Bailey: I would need to get the specific
numbers of the second phase. But that basically
includes -- the part of the force that would
possibly be deploying could be first-responders
or, on a contingency basis, ready to deploy to
those high-threat areas. Then phase three
would be all the rest of the force.
Q: So if you had a crisis, then your phase-two
troops would not have the vaccination?
Dr. Bailey: At this time, until we begin the
phase two, they would not be vaccinated.
Q: Are you essentially done with phase one, and
now you are halting vaccination of new
troops in phase two? Or what --
Dr. Bailey: No, we aren't halting the program
because we are in phase one now and
continuing phase one.
Q: Well, how many more do you have to go in phase
one, how many more troops?
Dr. Bailey: I would need to get you those
specific numbers.
Maj. Gen. West: But essentially you are rotating
people in and out of theater all the time, and
so you are continually having new people; plus,
you have new troops coming into a unit. So
you are essentially using about 75,000 doses a
month.
Q: A couple weeks ago, Secretary Cohen offered to
make the vaccine available to South
Korea, if they wanted it. Has there been any
follow-up on that? And what would do to the
program, if you had to, you know, share it with
South Korea?
Dr. Bailey: Well, we've had many different
requests at times for this vaccine and for other
medications and vaccines, and they are considered
on a specific basis, according to the
situation.
(To colleague.) Do you have anything to add to
that?
Q: Have any been granted?
Dr. Bailey: To my knowledge, there have been
grants at this point of smaller amounts.
Maj. Gen. West: There have been no vaccines given
to other countries as yet, although
several have asked for them. And -- but there
have been small amounts that have been sold to
State Department agencies, to veterinarians, to
people that work in the hide industry, to give
them protection against the disease.
Q: Well, has the South Korean military formally
asked for this?
Maj. Gen. West: We're in discussion with them
about providing it, and we think that they
should take it. And we should make it available
to them once we go into assured production.
Having your forces, both the American forces and
the Korean forces, vaccinated and
protected make it less likely that the North
Koreans would use it, and not only provides
protection to our forces but to everybody that
lives on the peninsula.
Q: Well, what would that do to the supply
situation, given the shortages?
Mr. Oliver: If you make a decision like that, it
affects it. We have essentially 430,000 doses
right now that are approved by the Federal (sic)
[Food and] Drug Administration, plus
600,000 that's in the pipeline -- so for about a
million. We expect to -- I expect to get
600,000 approved within the next couple of
months, and I also expect another 400,000 a few
months after that. So that is the amount that you
have total. We are using 75,000 a month.
In addition, there are over a million doses which
are also in reserve at Bioport, which we
could use if we had to. But we have not asked the
FDA to approve those, nor do I intend to
do so in the near future.
Q: Why has this process taken longer than
expected? And what specific problems has the
FDA come across at Bioport?
Mr. Oliver: It's taken longer than we expected
because we underestimated the difficulty in
going from a public state of Michigan facility to
a federal facility.
EXCUSE ME, IT IS A PRIVATELY OWNED FACILITY, NOT FEDERAL.
In addition, what you had
was a facility in which you were doing a safe and
effective vaccine for a fairly limited number
of people for years and years and years
IN ALL THESE YEARS, THEY HAVE YET TO SHOW US A SINGLE SATISFACTORY
INSPECTION REPORT BY FDA!
, and you have a use demonstrated. And then you
decide that you now have a new threat, right? You have -- they have
these various companies
COMPANIES??
that weaponize this, and so you have a new
threat. So you -- so we need to change the
quantity.
Essentially what we did was tore down that tried
and proven facility
OH MY LORD! GIVE US ONE SHRED OF EVIDENCE THAT PLANT EVER PRODUCED
VACCINE ACCORDING TO ACCEPTED STANDARDS
, which is the same
facility that's produced all the vaccine that
people have taken and will take under phase one,
and we're building a whole new facility. You
build a whole new facility, you have to deal with
all the changes in standards that have happened
in the drug administration, in the federal --
FDA over those years, and you have to build
those. We underestimated how difficult that
was going to take (sic) to address. And to be
honest with you, since the secretary said it has
got to be safe and effective, we'll eat that time
delay, and whatever extra money it costs, to
make sure that what we provide to our troops is
both safe and effective.
Q: What about those million doses in reserve? Why
can't you just start getting those
approved and using them?
Mr. Oliver: There are various technical reasons
that I don't want to at this moment. I was just
out there last Wednesday night, looking at them,
and reviewing the documentation. I don't
think we need them. I've got 14 to 16 months'
worth of vaccine at the moment, and there are
issues that I'm not ready to address.
THESE ARE LOTS THAT REPEATEDLY FAILED TESTING AND/OR HAVE OTHER
PROBLEMS. THEY COULD PERHAPS BE USED ON SERVICEMEMBERS UNDER EXECUTIVE
ORDER 13139.
Yes, ma'am?
Q: Can you talk a little bit more -- what is DOD
doing to, quote, "augment Bioport"? How
much is that going to cost in the near term? And
how much more money are you going to
have to put into this project?
The reason I ask -- I think it was back in
September that you redid the contract. You said you
underestimated -- you put more money in. Now
another whole load of money?
Mr. Oliver: Yeah, different issues, essentially.
In -- when we were looking at it before, what
happened was, they estimated how much it was
going to cost while they were a part of the
state of Michigan. The state of Michigan was
right that this was costing a lot more money;
they just didn't know what. And so the price,
when they were separated and you could
actually determine the cost, turned out to be
about three times what they'd estimated. That
was to take care of this problem.
Now the question is, how do we get them through
the FDA certification? I estimate that cost
is going to be equivalent to the -- what the cost
to maintain one airplane for one year, which
is about --
Q: What kind?
Mr. Oliver: Any kind -- about $7 million. I mean,
just to give you a feel for what the
magnitude is, I think it's going to be another $7
(million) to $10 million we need to put in.
And what we're doing is, the Army has -- the
Army's sent a team of three generals to Bioport
to look at it on Friday.
Q: (Off mike.)
Mr. Oliver: General Kern has assigned a brigadier
general named Dean Ertwine to look after
this program full-time. He is, in addition, going
to identify some other -- Dean's going to
identify some other people to help him with that.
And we're going to buy several million
dollars' worth of consultants to work on the
problem.
Q: So is that several million in addition to the
7 to 10 (million dollars)?
Mr. Oliver: No, ma'am. That falls under the 7 to
10 (million dollars).
Q: And are you going to -- I guess I'm still
confused, frankly, how you're feeling on how it
got to this point. This was a project that was
supposed to be a top priority in the Pentagon;
how did it get to the point that it's going to
cost another 10 million dollars, all of a sudden?
Mr. Oliver: Ten million dollars needs to be taken
in perspective, as I just gave you. I mean, it
is the amount of money it takes to maintain an
airplane for a year, roughly, or two airplanes.
It is essentially less than ten percent of what
the program would cost, so -- which does not
mean that I haven't yet figured out where to get
the money from, because I haven't. And it's
certainly a lot of money to me, but it's not a
lot of money when you consider the threat that
exists, and those people out there who have
weaponized this problem, and to whom we are
worried about, and also how important this is to
the secretary of Defense.
Yes, ma'am.
Q: Could you give us a little more explanation on
what the problem is? Is it that the
equipment you want to buy isn't out there, or is
it the accounting system that's hard to set up
-- what is it?
Mr. Oliver: Let me give you three examples,
because they did an inspection -- there's an
inspection out there which has about thirty
items. Let me give you three, and I'll try to make
sure I give you some of equal weight.
For example, let's say you have sterilized the
equipment. You sterilize the equipment, you put
it in a room -- you're not going to use it. The
question is, how long does it sit in this room
before such time as you ought to re-sterilize it?
Is that 24 hours; is that three days; seven
days? In other words, you ought to be able to
sterilize it and leave it for awhile. How long do
you have before you start using equipment.
Technical question has to do with medical things.
How long spores take to light. We don't
know that answer; had never addressed it before.
We're going to give that problem off to an
independent company to look at so I don't have
Bioport telling me that it's three months, and
somebody else telling me it's two days.
Anyway, need to do some tests, check it out
several times and write a report. That's an
example. Let me give you another example. In the
amount of time since we built the new
facility there have been lots of good government
tests that have changed with respect to how
do you check out, how much of the spore you have,
how do you check these various things.
Those procedures need to be written and tested
out for Bioport and established, and you
need to run them over and over again, so you make
sure people are doing right. That's the
second one, for example.
A third one is, what happens when you come up
with a thermometer that doesn't read what
you thought it would do, or you break a glass
beaker. How do you establish -- those are
called deviation reports. How long do you have
from when that happens until you write the
report? Do you want to set 48 hours, which is
perhaps reasonable. Do you want to set four
weeks? You don't want to set four weeks because
it's too long and people may have forgotten
it. Right now, there is no specification that nor
is where is it filed.
Q: Do these three examples then represent
disputes that you've all had with Bioport? Bioport
said we can leave this sterilized equipment --
Mr. Oliver: No. These are findings by the Federal
(sic) [Food and] Drug Administration of
things they think Bioport should do differently.
Q: Doesn't FDA have a set bit of criteria for
something of a lab like this? That it is three
months or it is two weeks that you can leave
sterilized equipment?
Mr. Oliver: It's my understanding what the FDA
has asked the lab what they believe should
be done technically, then the FDA says that's
okay or not. I went to an FDA meeting for two
hours two weeks ago, and that was essentially --
it was a discussion of statistics, but that was
essentially what happened.
Q: There are about thirty of these issues?
Mr. Oliver: Thirty of them, yes sir.
Q: Is there a copy of this FDA report?
Mr. Oliver: Obviously, there's a copy. I have no
idea whether or not it's related to FDA -- I
don't know whether it's restricted or not. I'll
have to check.
Mr. Bacon: I'll check for you.
Q: Isn't there also a problem with being able to
make your batches consistent, and so far
Bioport has been unable to make consistent
batches in terms of purity and potency?
Mr. Oliver: It's absolutely a question about
making them consistent. I think Bioport -- I think
the issue is, Bioport says we think they are
pretty consistent. The FDA says it doesn't meet
our specs yet. From the Department of Defense
point of view, we're not going to do this until
we're comfortable with what -- that meets FDA
specs and we're comfortable with whether it's
safe and effective.
Q: So if there's a six-to-twelve month delay in
phase two, what is the specific impact on the
U.S. military if it had to make a general
mobilization and deployment today to either the
Persian Gulf or Korea?
Maj. Gen. West: What we've done is used the
vaccine that we had available to vaccinate -- in
keeping with the protocol as fast as we could --
the forces that are already there on the
ground. Then we began identifying the people that
were soon to go; then we began
vaccinating the people that were flying in and
out of the theater. The next step, when we go to
phase two would be to vaccinate the force that
would be included in a build-up like we
experienced in Desert Storm. We're not there yet;
we couldn't do that today, and we won't be
able to do that until we go to assured
production. So, we're better off than we were two years
ago, but we're not where we want to be.
Q: Well, let me just make sure I very precisely
understand. You say we couldn't do that
today. What could we not do?
Maj. Gen. West: We could not today do a full
build-up to Desert Storm and have every
serviceman and -woman that was sent there
vaccinated on the battlefield.
If I could, while I'm here, add some information
to the question that I answered earlier. While
we have not sold any vaccine to any country since
we received the request from Korea, if you
go back across the complete history of the
program since we've been making the vaccine,
we've sold thirty thousand doses to Canada, a
little over ten thousand (doses) to Australia, a
thousand (doses) to Denmark and a thousand to
Argentina. And those are the only ones that
I know about at this time.
IMPORTANT INFO FOR THOSE OF US WONDERING WHICH COUNTRIES RECEIVED U.S.
VACCINE AT THE TIME OF THE GULF WAR. DENMARK, CANADA AND AUSTRALIA ALL
REPORT SIGNIFICANT NUMBERS OF CASES OF GULF WAR ILLNESS.
Q: The more --
Dr. Bailey: Let me give one other medical fact.
In the response to what we are able to do to
protect our troops, being that force health
protection is a main mission when we deploy
troops, in fact we would be able to provide, as
we did during the Gulf, immunizations that
would give protection. It doesn't have to be all
of the six in order for our troops to receive
some protection.
DR. ZOON NEEDS TO HEAR THIS: SHE HAS ENQUIRED WHY DOD HAS HELD UP ON THE
FULL SERIES AND REMINDED DOD THAT ONLY THE FULL SERIES HAS BEEN APPROVED
BY FDA.
Also, from a medical point of view, we do have
other mechanisms for protecting against an
anthrax attack. And that would include both the
gear that is worn -- the MOPP gear, and
other gear that protects them against chemical
and biologic weapons, biologic in this case --
as well as the ability to protect or provide
medical backup with antibiotics. So we are able to
provide, as we did during the Gulf, some
significant protection against anthrax.
THIS IS ALL ACCURATE, BUT HAS BEEN OMITTED BY DR. BAILEY IN HER PREVIOUS
PERFORMANCES.
Q: Is it not the case, though, that in every one
of the categories you've mentioned --
antibiotics, MOPP gear, and everything -- you
also have shortages in all of those inventories
and you couldn't possibly protect all the
soldiers with that stuff?
Maj. Gen. West: The problems that you get into
there are, we have good MOPP gear, and we
have MOPP gear available to outfit a force of a
Desert Storm size, but it has limitations in
that you can't wear it and fight in it 24 hours a
day. So, you desire and need additional
protection. The best protection that we can find
is the vaccine, and we want to vaccinate the
whole force as soon as we can; but we also want
to be sure that the vaccine that we use is
totally safe, that there have been no shortcuts
taken and no exceptions to the certification. But
as soon as we have assured production, it's our
goal and we want to vaccinate the first
responders and then the total force, so that we
can move people in and out of first responder
units without having to worry that we have
someone there that wasn't protected.
Q: Dr. Bailey, question. In your opening
statement, you talked about the Secretary making a
decision that phase two will not begin until both
the FDA and you are satisfied that
everything -- I want to understand, how much of
it is just meeting the FDA legal
requirements and how much does the Secretary have
further discretion? Would the
Secretary, for example, be able to say it doesn't
have to be FDA-approved? It's important
enough for national security that we go ahead
anyway. Can you explain that?
Dr. Bailey: Well, that would not be the case.
Clearly, we operate under the regulatory rules
set forth by the FDA.
BUT YOU DID NOT OPERATE UNDER THESE RULES WHEN YOU USED BOT TOXOID, PB
AND TBE VACCINES.
So, it would clearly the production would need to be under those
standards, and as well, standards that we set. We
also test all of the lots for purity and
sterility.
WHAT? WHO TESTS FOR PURITY AND STERILITY BESIDES THE MANUFACTURER, AS
MANDATED BY FDA?
So, we are testing as well as honoring all of the testing requirements
of the FDA.
Q: Then, I guess I don't understand why you say
this is Secretary Cohen's decision, when it
seems that many of the problems that you've
described are simply you don't have FDA
approval yet. You're still working through that.
PRECISELY.
Dr. Bailey: It is a time-phased program. And, as
you've heard we had three different phases
to the program. So, it is more that in looking at
where we are today and the production that
we have capable, we are looking for the assured
production that comes down the line which
will let us launch the phase two program.
Maj. Gen. West: Maybe I can help with that just a
little bit. If we mobilized to get at a Desert
Storm scenario or something like that tomorrow,
we would take the 400,000 doses that we
have on the shelf and vaccinate as many people as
quickly as we could, and then we would
use those doses in the pipeline to continue that
effort.
REMEMBER, THESE DOSES ARE NOT FDA-APPROVED. UNDER ORDER 13139?
But, without that mobilization
requirement, we would rather proceed with phase
one program, so that there is no danger of
reaching a point in phase one where you have
someone that started the six-shot protocol, and
not have sufficient dosages to continue that
protocol without interrupting it. So the step that
we are taking to not begin phase two is a step
that gives us more confidence that we will be
able to continue and complete all the protocols
that we began, as required by FDA.
Q: So it would just be a waste if you gave people
just some of the doses but not the full six?
Maj. Gen. West: It wouldn't be a waste because
you gain some immunity with each shot that
you get. But it would be a deviation from the
protocol that's established and approved by
FDA, and we don't want to get ourselves in a
situation where we might have to do that.
Q: Have you found that some of the doses that are
in the pipeline have been rejected as you
have looked at the lots; had 100 percent
acceptance of the pipeline?
Maj. Gen. West: All the ones that have been
released and are out to the troops -- and that's
why I referred to it as a "pipeline" -- are fully
accepted and met all the tests.
Q: But there's warehouses full of these doses
that have not been released, and you --
Maj. Gen. West: I wish there were warehouses
full; I mean, it's not quite that many.
Q: Refrigerators full, I'll put it that way. And
my understanding is, is you have tested some of
those. And you have rejected some, and you have
passed some.
Maj. Gen. West: Mm-hmm. (In agreement.)
Q: Is there any sort of -- what chunk of those
that you are looking at, are you throwing out?
(Pause.) Half?
Mr. Oliver: No. It turns out it's a terribly
difficult subject. It's the reason I was over at the
FDA talking about this.
And -- there is nothing actually quite as much
fun as spending an afternoon with statisticians
locked and talking about double-tailed
probabilities. But it essentially has to do with, "Does
your test -- does the standards that you set, 40
years ago, where you said, 'It has to be this' --
is (sic) that makes sense today or else -- or
does your data show that you should have said it
can by anywhere in this ellipse?" That's a
difficult -- that really is a complicated subject
matter.
Q: (Inaudible) -- you're throwing out? Some --
Mr. Oliver: I am not throwing out; I am putting
aside right now, some of them.
BE AWARE THAT THEY HAVE NEVER THROWN AWAY ANY OF THE OVER 20 LOTS THAT
FAILED SUPPLEMENTAL TESTING MORE THAN ONCE. AND THAT IS SCARY, FOR
THAT MEANS THEY RESERVE THE RIGHT TO USE THOSE LOTS IF ‘NECESSARY’.
And --
Q: Less than half; that's a million or --
(inaudible) -- a million?
Mr. Oliver: That's about a million.
Q: So they don't meet current new standards?
Mr. Oliver: No. What I have chosen to do -- for
various reasons, I have chosen not to test
them again. I have chosen just to put them aside.
I do not think we are going to need them. In
other words, I spent some time looking at this,
and I think we have enough that gives us time
enough to get the new facility tested by FDA,
and a safety factor. And, therefore, I am going
to focus on that and focus the team's attention
on making sure that Bioport gets requalified, and
not focus on this other problem for all
sorts of reasons having to do with distraction of
key personnel.
Q: Are the million immediately usable, if needed;
no?
Mr. Oliver: If you really needed them and you
were -- no, no, I am serious. It's -- the
question is if you're --
Q: (Inaudible) -- reasonable?
Mr. Oliver: -- yeah -- because the question is --
we get back to an issue about whether or not
the president or the secretary of Defense could
choose to do that. And let me leave that for a
different time.
HERE IT IS: WE WOULD USE EO13139 TO FORCE THESE MULTIPLY FAILED VACCINE
LOTS ON TROOPS IF WE CHOSE TO DO THAT. NOW WE KNOW WHAT THAT ORDER WAS
ABOUT, AND IT IS BY NO MEANS PRETTY.
I think that I would take those doses. I think
they would protect me from anthrax.
Q: Would they expose you to anything else?
Mr. Oliver: I don't think so. It's --
Q: How about these soldiers who might not feel
exactly the same as you?
Mr. Oliver: Yeah. And so what happens is I am not
going to even worry about -- what I am
telling you is I have put aside a set of them --
Q: Not to back up, but just as a bunch of other
reasons.
Mr. Oliver: For a whole bunch of reasons, which
had to do with how much time we had and
the facilities it takes to test them and -- and
various questions I didn't want to address, and
then because of what I looked at that I thought
would fully meet the FDA's criteria was
enough to give me phase one --
Q: Are all of these doses from the old plant?
Mr. Oliver: They are all from the old plant.
Q: And why was the old plant torn down?
Mr. Oliver: Because when I was providing the
annual doses for 1,200 veterinarians who did
large-animal care and for a few wool workers, and
for some people in the laboratories like
Anna, who works for me, who has had 18 anthrax
doses,
1200 DOSES WERE USED ON A FEW LAB WORKERS, NO WOOL WORKERS IN ABOUT
TWENTY YEARS AND PERHAPS A HANDFUL (IF THAT) OF VETERINARIANS, AND A LOT
OF MICE, GUINEA PIGS AND MONKEYS. WHY CAN’T OLIVER AND BAILEY TELL THE
TRUTH?
I was working at a level -- you
know, I only was producing so many, right? That
is about 2,000 a year, roughly. Okay?
Now, I want to produce 400,000 thousand a month,
if I am going to worry about all of the
military forces, plus the allies that I think are
going to have to do this. That's a different
facility.
And so we tore down the old one to build a new
one. The new one can produce at its
maximum -- I don't expect it to get there --
400,000 a month. Do you understand what I am
saying, a difference in magnitude?
LAST YEAR YOU CLAIMED YOU WERE SPENDING A SMALL SUM TO DOUBLE THE
CAPACITY OF MBPI. NOW YOU CLAIM AN INCREASE OF FROM 2,000 DOSES A YEAR
TO 4,800,000 DOSES.
Q: I am wondering why you tore it down before the
new one was certified?
Mr. Oliver: I don't know. That was a different
decision. But I'll give you a reason why I
might have made that if I were in his place.
This a funny virus (sic) [bacterium] in that most
viruses (sic) [bacteria] are -- and if you are
doing most things in the pharmaceutical world,
you would produce something; then you'd
run through, and you'd flush the system, and
you'd produce something else. In this case, the
FDA rules are you cannot produce anything else in
that factory once you've started; you can
only do anthrax, because you expose it to a live
virus (sic) [bacterium] and because it's really
hardy and carried through the air -- lots of
problems. So you are restrained -- have various
restrictions on it for safety reasons. So I can
see why one might have done that.
Q: What's the sort of endgame here? You say six
to 12 months, but have you given Bioport,
you know, some sort of date on the calendar by
which they have to get their act together?
And what's to prevent the situation from just
drifting on and being here in another three
months and having to give them more money?
Mr. Oliver: What's going to prevent this is the
loyal fourth estate, which is going to help me
by making this unpleasant until we get this
resolved, right? That's -- let me answer the second
one.
The first question is, I did not give them a
date. Let me tell you why I don't want to give them
a date. I don't want to give them a date because
of the secretary's guidance, which is it's going
to be safe and effective. If it's going to be
safe and effective -- if I'm going to worry about
safety paramount, I cannot also give them a date.
And at the same time, General Kern -- Lieutenant
General Kern Saturday morning brought
in a brigadier general, Dean Ertwine, and said,
"This is your guy. He's running this place up
in Aberdeen right now. He is your guy, full-time,
till this is solved."
So I think you can get by this out -- there are
going to be a lot of internal dates, but I'm not
going to give them a date by which they have to
produce.
Q: But if they're the only producer in the
country, what's the stick for getting this solved?
Why does it -- what avoids it (sic) from just
drifting on and being a problem forever?
Mr. Oliver: Because I think the people are
inherently good people. The people are inherently
good people. People understand the problem. We're
going to put a lot of assets in this. This
is no different than all the depots that exist
across this great country and lots of other things
for which the government runs, because it feels
like it must. It's absolutely no different. And
the reason that works is because you have good
people.
NO COMMENT ON THIS BIT OF AIRY FAIRY PHILOSOPHY PRODUCED TO AVOID
ANSWERING THE QUESTION.
Q: Do you feel 7 to 10 million (dollars) will
solve it?
Mr. Oliver: Yes. That was my estimate last
Thursday, and I haven't looked at it since. I took
this, asked my staff to review it -- they have
not gotten back to me.
Q: Is this 7 to 10 on top of the 18.7 million
that Bioport was given in August?
Mr. Oliver: To square away the contract because
the contract price was all off because what
the state of Michigan thought they were spending
was not even close to what we were really
spending, yes.
Q: So you're looking at 28 million, basically.
IN ADDITION TO THE ORIGINAL CONTRACT AMOUNT.
Mr. Oliver: Yes. I'm looking at 7 to 10 more.
Q: Exactly where is this plant being built, and
how much of it has been completed?
Mr. Oliver: Same place -- same place, it's all
completed.
Q: What's the town?
Mr. Oliver: Lansing, Michigan. East -- Lansing,
Michigan. You go up to Lansing, land at the
airport, drive out of town and take a right.
(Laughter.)
Q: I have just a math question. With these
million doses that there are problems with, where
did they come from? Did they come from the old
facility? And if so, like, how does the math
work out to give you two thousand a year?
GOOD QUESTION.
Mr. Oliver: I didn't say they had problems. I
didn't say they had problems.
SAY IT THREE TIMES, CLICK YOUR HEELS TOGETHER, AND IT MIGHT COME TRUE.
Q: These million that you've decided not to deal
with at the moment, where did they come
from?
Mr. Oliver: (They) are from 1985 on,
IF TRUE, THEN THEY ARE LEFT OVER FROM THE GULF WAR SUPPLY AND COULD BE
TESTED FOR CONTAMINANTS AND OTHER PROBLEMS.
they were produced in excess and they're stored there.
Essentially, they're stored in a cold-storage
place.
Q: So they were producing it at a fairly high
rate. I mean, it couldn't be two thousand a year
since 1985 --
Mr. Oliver: No, they weren't -- what I'm saying
is, that was the demand. So it was sized for
the demand plus a chunk, but it wasn't sized for
what we're --
Q: I guess that brings me back to Jim's question,
which is, Why tear it down? You said it was
a tried-and-true facility that was working. Why
tear it down before you have another
tried-and-true facility? When you look back on
the decision, do you think that was a smart --
Mr. Oliver: I was driving west at the time --
(laughter).
Q: Do you think it was a smart decision?
Mr. Oliver: I was driving west, I was looking at
the sunset -- I don't know.
Q: You have --
Q: Can you answer that, please?
Mr. Oliver: Yes, Randy will.
Maj. Gen. West: It's not like you tore down a
facility so you could build another one
somewhere else. There are economies of scale to
building the new facility to increase the
production rate where the original facility was,
because, you know, there are levels,
recontainment requirements and things like that.
And part of the problem with the million
doses that's out there isn't necessarily that
there's been something found wrong with it, but
rather that we haven't had time on the production
line within the existing plant capacity to
retest and recertify that vaccine.
RETEST AND RETEST AND RETEST UNTIL IT MIRACULOUSLY PASSES YOUR TEST!
So what we had to do was take an existing
facility that couldn't meet our demand and
upgrade it to meet the demand that we need to
vaccinate a 2.4 million-man and -woman force.
Q: Just explain -- is this what you meant, then,
that to build another facility alongside of it,
then to close down the facility afterwards, you
can't ever reuse it, you'd have to do some big,
like, Superfund cleanup to get rid of all the
anthrax, or what -- is that the idea?
Mr. Oliver: You have to burn -- yes.
Q: You burn it down.
Mr. Oliver: You have to burn it.
And what Randy's talking about is, it turns out
there are bottlenecks in various procedures
when you review it. And so we are going about
looking at various parts of the country, not --
that don't produce the anthrax vaccine itself,
that serum, but there are other parts to it --
there's the storage, there's the testing of it,
and some other things. The question is, can we
pass it on to some other agencies or other
facilities around the country? I'll pass on another
WATCH OUT, THIS METHOD HAS BEEN USED TO OBFUSCATE THE PRODUCTION OF
VACCINE IN OTHER FACILITIES BEFORE. VACCINE MUST BE HELD ON PREMISES AT
BIOPORT UNTIL RELEASED FOR USE BY FDA. STORAGE AND TESTING ARE REQUIRED
TO BE DONE ON SITE. IF THIS FDA-MANDATED PROCEDURE CHANGES, START
LOOKING FOR UNLICENSED PRODUCTION FACILITIES --
Q: And what was the original cost estimate again?
Mr. Oliver: It was $7 (million) to $10 million.
Q: No, that's the increase.
Mr. Oliver: Yeah.
Q: But what was the original cost estimate?
Mr. Oliver: The original cost -- I need to check
and get back to you. I need to check and get
back to you because I don't have the number. I
think the original number was in the order of
$130 million.
Q: The more you describe this FDA inspection, it
sounds like basically Bioport failed the
inspection.
Q: Yeah.
Mr. Oliver: Yeah, except that what you're talking
about is sort of a rolling inspection. In other
words, the guys come in, and they look at it, and
in some cases I have been told that the
people end up with something like 100
deficiencies in the first test. And they do -- they go
in, figure out a way to fix this, write a letter
back to the FDA. The FDA comes back again
and reviews. In other words, you ought to expect
in this kind of inspection several
inspections before you get to the point that the
people are comfortable.
Q: How many inspections -- (off mike)?
Mr. Oliver: One. In November. They have not yet
written their letter back. I've gone over and
talked to the FDA. We're going maintain close
contact with the FDA on this. We're --
Q: So you have --
Q: But the facility's done?
Mr. Oliver: Hm?
Q: Is the facility done, except for the
certification?
Mr. Oliver: The facility is finished and has
certification, but if -- there are probably -- that's
not a -- the certification is at least 50 to 70
percent of the whole process, you know, that's not
--
THE FACILITY REQUIRES A LICENSE SUPPLEMENT FOR VACCINE TO BE SHIPPED FOR
USE AND THEY DID NOT RECEIVE THAT AS A RESULT OF THIS 11/23/99 FAILED
INSPECTION.
Q: So there are 30 issues that the FDA found
needed to be addressed. But when they come
back on subsequent inspections, they might find
additional things. So the universe might go
up, and so it would keep rolling until the whole
--
IN FACT, THE LAST PARAGRAPH OF THE REPORT SAYS, "THE OBSERVATIONS NOTED
IN THIS FDA-483 ARE NOT AN EXHAUSTIVE LISTING OF OBJECTIONABLE
CONDITIONS..."
Mr. Oliver: I would expect the universe to go
down and up at the same time, right? And so
what you have to do -- what Bioport has to do and
we have to make sure they're doing is they
not only have to address the deficiencies the FDA
have found, they have to address the
underlying cause and make sure they've addressed
that.
Q: Can you go back over these different
quantities of doses you mentioned? You say you
have 430,000 --
Mr. Oliver: Four hundred thirty thousand that are
ready for issue; 600,000 in the pipeline.
Q: In the pipeline means not certified.
Mr. Oliver: No, no. Fully certified, out in the
world, going to various people, being
distributed.
Q: So the difference between ready-to-use and
in-the-pipeline is what?
Mr. Oliver: Nothing.
Q: Ready-to-use means it's in our refrigerator
here, pipeline is it's in the --
Mr. Oliver: It's in our refrigerator here; it has
not yet been sent out in the pipeline to the
troops.
Q: Okay, so you got a million ready to use.
Mr. Oliver: Got a million ready to use.
Q: That's different from the million that you do
not plan to use.
Mr. Oliver: Right -- separate million.
Q: The million that's ready to use are the 14 to
16 months' worth of vaccine.
Mr. Oliver: No, because I've got 600,000 -- let's
take the million that's set aside and call that
A. Let's put the million that is fully certified,
has met all the FDA requirements, and we'll call
that B. Then there are 600,000 that we'll call C,
that's separate from all those, and which I
expect Bioport to have discussions with the FDA
and the FDA approve within the next thirty
days. And then we'll call another category D,
which is about 400,000 and I expect that to get
approved by FDA within several months.
IS THIS WHAT HE SAID BEFORE?
Q: So that's two million, when you add category
B, C and D, right?
Mr. Oliver: Yeah. Just leaving A aside, B and C
is two million, divide that by 75,000 and
that's the number of months. Actually, I've got a
couple extra months in there because we've
got -- I mean, we are going to wait until this is
absolutely safe and effective before we
distribute it.
Q: There's a difference in the potency and purity
requirements of the new batches than of the
old batches, is that not correct?
Mr. Oliver: That's not correct, but I don't want
to mislead you.
Q: The old process.
Mr. Oliver: The FDA has not approved the new
process yet -- for potency. I know where
you're going.
Q: Old process -- you were producing a vaccine
that, when you finally have a certified new
process, these will be qualitatively different,
will they not? There will be more excess
biological material in the old stuff than you
will allow in the new stuff.
Mr. Oliver: Let me get back to you, because I
could talk about potency, but I can't talk about
the purity.
Q: Let me try it this way: Is it an issue that in
the old plant the FDA, in sort of a grandfather
clause situation -- that it had things that it
had to meet under the -- when it was first set up
and was operating under that, and as long as it
continues to operate, then it's okay. But now
you've got a new thing, and you've got a whole
set of rules that are stricter than they used to
be, and now you've got to jump through more hoops
to make it work. Is that basically it?
Mr. Oliver: It's precisely it.
Q: The GAO in October raised some concerns about
the monitoring of adverse reactions by
the Defense Department. Has that concern been
addressed?
Dr. Bailey: We have -- we'll both answer that. We
at this point are monitoring side effects
through the VAERS system, which is the Vaccine
Adverse Effect Reporting System. And
that system also is reviewed by our AVEC, which
is an independent group that reviews it for
us as well.
Maj. Gen. West: The VAERS system was already out
there and is used by the complete
medical profession, not just DOD.
What we did in response to the GAO report is go
back out and be sure that all of our people
were educated to know that any individual can
decide to submit a VAERS report, and no one
is going to stop him or her from doing that, and
they're all going to get looked at.
We've also made sure that we have reeducated our
doctors and nurses and corpsmen to know
how to handle those and to be sure that they get
-- they all get processed, and they get
processed as promptly as possible.
THE AVIP IMPLEMENTATION PLAN INSTRUCTS HEALTH CARE PROVIDERS TO PROCESS
THROUGH DOD AGENCIES AND NOT SEND ANY REPORTS DIRECTLY TO FDA/CDC. IT
ALSO RESTRICTS REPORTING TO VAERS. HAVE YOU JUST CHANGED THESE
REGULATIONS?
But, I mean, the system that was there, other
than additional attention to it and additional
personnel that we've put on it to monitor it, is
still the system that we're using.
Q: What are the chief minor side effects that --
Maj. Gen. West: The chief minor ones would be
soreness, redness around the vaccination
site, occasionally a small lump that accompanies
or closely follows the vaccination.
Q: Can I go back and ask Mr. Oliver? I'm still
confused on one point here. Is there any
difference in the potency of the new -- of what
is produced from the new facility versus
what's in stockpile? Or are they identical?
Mr. Oliver: When the FDA finishes and approves
it, we do not expect there to be any
difference in the potency.
ACCORDING TO DOD’S TOP ANTHRAX VACCINE RESEARCHER, POTENCY VARIES BY A
FACTOR OF 40 (4,000%) FROM ONE LOT TO THE NEXT.
Q: But you do expect a difference in the purity?
Mr. Oliver: I don't know that. That's -- I took
that for fraction -- I don't know the answer,
because I didn't -- I have not focused on it.
I've got to get back to you. There's not going to
be a difference in potency now, but I don't want
you think later on I misled you.
THERE IS NO PURITY TESTING IN FACT, NOR CAN THERE BE, SINCE THE VACCINE
COMPONENTS HAVE NEVER BEEN DEFINED. THERE IS A TEST CALLED A PURITY
TEST BUT IT ACTUALLY IS NOT.
I do expect the FDA shortly to approve a change
in the potency test, which is statistically
identical and even better than the previous
tests.
THE PREVIOUS TEST WAS MEANINGLESS.
Okay? That's what I was over there listening
to these people argue about. So please don't get
confused.
Q: So if there is a change in the potency test,
do they have to go back then and look at what's
in inventory before you give them to soldiers to
--
Mr. Oliver: No, ma'am. No, ma'am.
Q: Why not?
Mr. Oliver: The answer is no.
BECAUSE THEN WE MIGHT LOSE ALL OUR LOTS.
Dr. Bailey: I just want to add, from a sort of
biochemical point of view, the sum of what's
happened here is that there have been advances in
the ways in which vaccines are both
produced and tested. And so that's some of what
the changes are in the criteria.
For instance, there are immunoassays that can be
done, that could not have been done 20
years ago, to check for potency, for instance.
BUT THERE IS A MUCH SIMPLER, LICENSED POTENCY TEST THAT THE VACCINE IS
UNABLE TO PASS: GUINEA PIGS ARE VACCINATED WITH VARYING DILUTIONS OF AVA
AND INJECTED WITH ANTHRAX, AND SURVIVAL RATES OBSERVED. THAT SEEMS
PRETTY STRAIGHTFORWARD. AREN’T THE VACCINATED GUINEA PIGS SURVIVING?
Q: So in view of what's in stockpile since 1985,
how can you be assured of both its purity
and its potency if there's all this new testing
out there?
Mr. Oliver: You have to test. Anything that comes
through has to be tested new, anew. In
other words, you can't take it and leave it
alone. You have the requirements -- for example,
either three years or five years -- that it has
to be tested again before it's released, even though
to go into the original stockpile it had to pass
a test to start with it. Then it has to pass a test
periodically while it's there. And then it's
going to have to pass another test to be released.
Maj. Gen. West: And Secretary Cohen's mandate,
when he reinstituted the program, was that
it would all be retested using the current
standards, using state of the art --
NO. THE SUPPLEMENTAL TESTING REQUIREMENTS ARE CLAIMED TO BE LESS
STRINGENT THAN RELEASE TESTS, ACCORDING TO DOD DOCUMENTS, AND TO USE
ESSENTIALLY THE SAME TECHNOLOGY AS THE TEST FORMAT LICENSED IN 1970.
Q: Does that include the 430(,000) and the
600(,000) that's -- there were -- okay.
Mr. Oliver: Yes, ma'am.
Q: And none of this -- none of the 430(,000) or
the two sets of 600,000 came from the new
facility, correct? They're all --
Mr. Oliver: Everything came from the previous
facility.
Q: Previous facility.
Mr. Oliver: There's nothing out there from the
new facility, because it hasn't passed the FDA
standards.
Q: Are you concerned that this is going to fan
the flames of that minority of folks that are
unhappy with taking this or refusing to take it?
Dr. Bailey: Well, I for one am concerned that we
get that information out -- I think this is
why this is helpful today -- that safety and
efficacy are prime considerations in approval here
of any new vaccine.
But I do want those who would consider not taking
this vaccine for any reason to reconsider,
given the deadliness of the anthrax biologic
weapon and the effectiveness, the incredible
effectiveness for protection, of the anthrax
vaccine.
BASED ON WHICH TEST? SEE MY APRIL 29,1999 CONGRESSIONAL TESTIMONY TO
REVIEW ALL THE MOUSE AND GUINEA PIG DATA AVAILABLE LAST YEAR.
Q: When we were last briefed on this matter, the
side effects were described as minor. Since
that time, has anybody come up with -- have there
been any serious illnesses or any deaths
associated with this?
Dr. Bailey: There have not been any deaths, and
that's important to note, because as you
know, with other vaccines and medications, in
fact, there are. This vaccine is as safe, and at
times recorded to be safer than some of the
vaccines that we give to children in America. We
are actually seeing fewer side effects than might
have been expected.
48% SYSTEMIC REACTIONS IN THE TRIPLER STUDY NOW ONGOING: ACCORDING TO
DR. BAILEY, THIS RATE SHOULD HAVE BEEN LESS THAN 0.2%
Although we do see
about thirty percent of the people who receive
the vaccine get a sore arm. I, myself, in having
taken it, have gotten a sore arm each time, but
not unlike other vaccines that I have received.
Occasionally, and I didn't have this occur,
you'll get a little knot, and that will go away within
a period of weeks. So, this vaccine has been
shown to be not only effective, but in fact safe,
and on par with other vaccines that we give. We
are continuing to monitor those side effects,
though.
Q: So, no new reports of side-effects?
Dr. Bailey: No, except I'd like to give you the
update, in that we have reviewed of the VAERS
Reports: 559 of those reports.
I SUGGEST A CONGRESSIONAL REQUEST FOR GAO TO REVIEW THESE 559 REPORTS.
DOD’S INTERPRETATION OF THEIR SEVERITY AND LIKELIHOOD OF VACCINE
CAUSATION IS VERY DIFFERENT THAN MINE.
And, I should tell you that out of that, we've had 22 people
who had in fact to be hospitalized, but it was
found that of those 22, only 6 were related the
hospitalization were related to the vaccine.
Importantly, of those 6 -- now this is 6 out of
over a million vaccinations -- 6 people had to
be hospitalized, but all four allergic-type
responses, which were severe enough to require
them to be out of duty for 24 hours and
hospitalized, but they were all related to the injection
site. Soreness in the arm, redness in the arm
that was beyond what we would ordinarily
expect. So, again, very low incidents of side
effects. Six people with the side effects that
required that kind of a response from the medical
team, and that was out of 383 thousand
individuals who received those vaccine -- that
vaccine.
DR PITTMAN REPORTED TO THE IOM COMMITTEE IN JUNE THAT THERE WAS A CASE
OF LUPUS, OF MULTIPLE SCLEROSIS, AND OF GUILLAIN BARRE. THE 559 VAERS
PROVIDE A MORE COMPELLING STORY OF VACCINE REACTIONS. WHY DO DOD
SPOKESPEOPLE FOREVER CONTRADICT ONE ANOTHER?
Q: Of the six, after a few days what was their
status?
Dr. Bailey: Exactly, they've completely
recovered.
THEN WHY DO I GET ALMOST DAILY CALLS FROM PEOPLE WHO ARE BEING BOARDED
OUT OR REFUSED CARE FOR COMPLAINTS TEMPORALLY RELATED TO VACCINATION?
WHAT ABOUT THE SEVERAL CASES WHO WERE ON LIFE-SUPPORT POST-VACCINATION,
OR WHO DEVELOPED LIFE-THREATENING STEVENS JOHNSON SYNDROME, OR DIED OF
LEUKEMIA?
Q: Thank you very much.