-Caveat Lector-
""" Another example is the Assistant Secretary of Defense for Health Affairs
inferring in a 14 Aug 1998 press briefing and again during her
Congressional testimony last March that the anthrax vaccination policy had
been approved by a Yale medical school professor. However, in a letter to
Rep. Christopher Shays (R-CT) this past April the doctor, who is a
gynecologist, admitted to “no expertise in anthrax.” DOD has never
acknowledged this admission by their “expert” or explained why they asked
a gynecologist to review a vaccination program. """
<<This smacks of the medicoes contra firearms "expretise". A<>E<>R >>
""" Additionally, a November 1998 Nation Magazine article reported, “at the
end of 1997 Russian scientists had published a paper in the British medical
journal Vaccine describing the creation of a genetically engineered anthrax
strain that was resistant to standard Russian anthrax vaccine.” Alibek stated
in another interview: “Vaccines are not the answer.” """
<<This seems to fall in line with the 'designer drug' scheme except this is the
'designer disease' (as if Nature wasn't doing well enough all alone {ref
posting on antibiotics this week}). A<>E<>R >>
------- Forwarded Message Follows -------
Date forwarded: Thu, 9 Sep 1999 03:12:21 -0400
This Special Mailing is provided to educate and inform SFTT readers on a
major issue affecting the readiness of the US military. SFTT continues to
support calls for an immediate cessation of the current anthrax
vaccination program pending an independent investigation to determine the
safety and efficacy of the vaccine.
------------------------------------------------------------
“Shooting Straight on Anthrax”
By Redmond H. Handy
A White Paper on the August 5, 1999 DOD Press Briefing
On August 5, 1999, Mr. Ken Bacon, Assistant Secretary of Defense for
Public Affairs held a briefing for reporters on the DOD anthrax
vaccination program. He and the senior military officers who briefed the
reporters made statements about the anthrax vaccination policy that are in
direct conflict with General Accounting Office (GAO) investigations and
testimony before Congress. This article reviews selected DOD answers to
reporters’ questions during that briefing (the briefing excerpts are
preceded by "Q" and "A" etc.). We encourage you to read the entire
briefing transcript which is linked to on the SFTT web site at the address
listed below.
This article is also posted on the SFTT website at
<http://www.sftt.org/articles/shooting_straight.shtml> in the articles
section and uses hyperlinks to other sources so that readers have access
to more detailed – and accurate -- information
Q: Why can't this be on the record?
Mr. Bacon: This is pretty technical stuff and I thought it would be a
freer flow, more of a dialogue, if we did it this way…
Q: There won't be any names attached to it, though.
Mr. Bacon: We're going to do it this way, and there will be future
opportunities to talk about that…
Comment: Mr. Bacon’s linkage of anonymity and the disclosure of technical
details, of which few were discussed in the briefing, is difficult to
understand. He gave similar vague answers justifying anonymity for senior
military officers when the mandatory anthrax vaccination policy was
announced on 15 Dec 1997. Why are general and flag officers -- who are
supposed to be warriors -- hiding behind a shield of anonymity when
discussing this policy?
DOD has lacked candor in the past when addressing servicemembers’ health
concerns. DOD took years to admit the health risks to servicemembers
exposed to nuclear tests in the 1950’s, Agent Orange during the Vietnam
War, and chemical weapons during the Gulf War. Anonymous briefings by
senior officers on the anthrax vaccination policy display a similar lack
of candor. Rightly or not, this anonymous approach fuels the perception by
military personnel that they may once more be used as “guinea pigs” in a
DOD experiment.
Army general officer briefer: “ I've got to tell you, personally it would
be irresponsible and it's unconscionable that we would take a trooper into
that threat area and not be vaccinated… And as a leader, I can't fathom
that we would ever take a trooper into that threat environment without
being vaccinated.”
Comment: This statement mirrors SecDef Cohen’s remark last March that he
would be “derelict” in his duties if he did not mandate the anthrax
vaccine. DOD’s attempt to frame the anthrax vaccine as moral imperative
may be an effective way to shut off debate about its safety, efficacy and
doctrinal necessity. However, this approach ignores the fact that our
major adversaries since WWII have had weaponized anthrax and that the FDA
first licensed this vaccine in 1970. Does this mean that every SecDef and
general officer since the Nixon Administration has been derelict because
they did not mandate use of the vaccine?
A 16 Aug 1999 Washington Post op-ed observed that, “while the risk of
bioterrorism may have increased in recent years, insisting that a real
attack is imminent or inevitable is gratuitous. Indeed, continuing a
stream of alarmist statements is likely to provoke only more anxiety and
more hoaxes.” The article also observed that “last month Secretary of
Defense William S. Cohen warned that a biological weapons attack on
American soil could be imminent.”
Interestingly, senior military officers did not make alarmist statements
about the anthrax threat until Mr. Cohen became SecDef in 1997. According
to a 14 Aug 1999 Washington Post op-ed, Cohen has “made the potential use
of biological or chemical agents by terrorist groups or individuals his
personal signature contribution to the national security debate in the
past several years.” Senior officers may also have been influenced by
SecDef Cohen’s firing of a USAF general in 1997 over the Khobar Towers
bombing – essentially setting a “zero-defect” force protection standard.
Since then, any policy labeled as “force protection” is accepted without
question and is promoted with statements like the following from a 14 May
1999 message from the Air Force Vice Chief of Staff to commanders:
“anthrax is a mortal enemy that our airmen must be prepared to confront
and conquer.” By necessity this rhetoric makes a decades-old weapon an
“enemy,” instead of those who use them – which would be difficult since
there has never been an anthrax attack before.
Q: Sir, if the enemy knows that all your troops are vaccinated and they
use a different agent that's not anthrax, then what do you do?
A: I'm going to let the chemical experts answer that question when they
come up here and talk about that. There are some solutions there…
Comment: Unfortunately, the “chemical experts” who followed did not answer
the question, except to say they were protecting against the “most
dangerous threats.” But they are really only protecting against one
threat. Reporters have asked similar questions before, and DOD briefers
have given equally unclear answers. At the 15 Dec 1997 briefing, when
asked whether DOD was starting a biological arms race by mandating this
vaccine, the anonymous senior officer answered: “I don’t know. It could
be, but I’m not prepared to answer that.”
Q: Why do you think that is? Why so much trouble with this one [vaccine]
in particular?
A: I think a lot of it has to do with the Internet age. There's this
tremendous amount of information out there that our youngsters can go
right to the net and pull down information, and in fact there's a lot of
disinformation on the Internet. Very, very aggressive, I think,
disinformation about the program. We have a different generation today and
they have that access to that.
Comment: DOD has repeatedly characterized any information that disagrees
with their position as “disinformation.” They seem particularly frustrated
that servicemembers are able to quickly locate information via the
internet – especially when it disproves DOD claims about the anthrax
vaccine.
For instance, a 15 Dec 1997 DOD press release claimed of anthrax vaccine,
“It has been widely used in the United States since the early 1970s by
livestock workers and veterinarians.” But on 26 Apr 1999 the Hartford
Courant reported that an Army spokesperson admitted this was false.
Despite this false claim, a DOD website message by the former Commandant
of the Marine Corps still makes this assertion.
Another example is the Assistant Secretary of Defense for Health Affairs
inferring in a 14 Aug 1998 press briefing and again during her
Congressional testimony last March that the anthrax vaccination policy had
been approved by a Yale medical school professor. However, in a letter to
Rep. Christopher Shays (R-CT) this past April the doctor, who is a
gynecologist, admitted to “no expertise in anthrax.” DOD has never
acknowledged this admission by their “expert” or explained why they asked
a gynecologist to review a vaccination program.
Last, the internet has made letters from two Secretaries of the Army,
Michael Stone in 1991 and Louis Caldera in 1998, available to
servicemembers. These letters acknowledge “unusually hazardous risks
associated with potentially severe adverse reactions and the potential
lack of efficacy of the anthrax vaccine.” In both letters the Secretaries
of the Army indemnified the manufacturer from liability for harm to
servicemembers by the vaccine.
Q: What do you say to those that have trouble, whether it's valid or not
in your mind, what do you say to them that say, 'I don't want to do it?'
A: …If you're going to go into combat you don't want to wear your helmet,
I'm sorry. You're going to wear your helmet...
Comment: Senior officers have frequently used the “helmet analogy” before.
Yet, DOD has not identified a single servicemember opposed to the
mandatory anthrax vaccination policy who has ever refused to wear a helmet
(or ever refused a vaccine other than the anthrax vaccine.) Congressman
Christopher Shays responded to DOD’s “helmet analogy” by stating: “After
military service, the uniform comes off, but the anthrax vaccine stays
with you for life.”
Q: So the incentive to [Bioport], just to clarify this point, is that
they continue to produce this vaccine, the government covers their costs
of production, they get to stay in business, and they have the potential
to make a profit with other customers, and without this help they'd
probably not remain in business. Am I reading this correctly?
A: That's correct. But let's not forget that the key here is that we get
our vaccine.
Comment: In 1998 Bioport – a start-up company with no track record --
bought the anthrax vaccine plant from the State of Michigan and signed a
sole-source contract with DOD to produce vaccine. On 30 Jun 1999 the CEO
of Bioport told Congress that “BioPort has incurred losses at a rate that
cannot be sustained in the future.” Subsequently, during the 5 Aug 1999
briefing, DOD announced that it would nearly double the amount paid to
Bioport under the contract from $25.7 million to $49.8 million -- while
receiving 25% less vaccine. Additionally, DOD agreed to advance Bioport
$18.7 million to solve their cash-flow crisis. The GAO reported that
“BioPort’s cash flow problem is due to its inability to achieve its overly
optimistic business plan.” And on 6 Aug 1998 the New York Times reported
that a Bioport spokeswoman said of the company's executives: "They did not
begin to anticipate the cost of producing the vaccines."
Q: There were other companies that bid on this, and I realize that
Michigan made the sale, not the Pentagon. But who are those other
companies, and how did this company end up in the hands of this holding
corporation that's based in the Caribbean and apparently doesn't have a
lot of resources to sustain itself? How did that happen? Have you explored
that at all?
A: I really wasn't involved. That was completely between the State of
Michigan and Bioport. I can't really answer that.
Comment: DOD’s actions attempt to guarantee the survival of a poorly
managed, start-up company -- and the stakes of its investors. One of those
investors is Admiral William Crowe, who was given 13% ownership in Bioport
– for nothing. According to an 8 July 1998 New York Times article, he “was
one of the most senior military figures to support Mr. Clinton in the 1992
Presidential campaign.”
Army briefer: “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…” [and later]
Q: I want to go back to your statement that you planned to shut down the
plant. The GAO testified at the congressional hearing that the state
decided to get out of the anthrax business when FDA came in and inspected
them and they weren't prepared to make the financial commitment to make
the improvements that were necessary.
A. “There's been a great deal of confusion about that … There were no
issues that FDA had with the purity, the strength, any of the things that
they want when that vaccine rolls out at the end, but there were
bookkeeping difficulties…”
Comment: Contrary to the assertions of this anonymous senior military
officer, a 29 Apr 1999 GAO report found: “The FDA inspections of the
facility where the licensed vaccine was manufactured uncovered numerous
problems. The facility received warning letters from FDA, including one in
March 1997 stating its intent to revoke the facility's license.” The GAO
report also described manufacturing deficiencies found by the FDA “that
could compromise the safety and efficacy of any or all batches.”
In fact, Bioport’s Chief Operating Officer admitted to Congress that,
“immediately after receiving the [warning] letter, we met with our
clients, including the DoD, to rapidly develop and execute a comprehensive
plan to resolve FDA concerns about our operation.” However, despite his
actions, a 20 Feb 1998 the FDA inspection report found, “the manufacturing
process for Anthrax Vaccine is not validated.” The report specifically
criticized the vaccines’ purity, potency, sterility, and stability. All
vaccine used to-date was manufactured under this non-validated process.
Q: You're still using the untested vaccine?
A: No, as the gentleman said, this vaccine has been tested and this
contract change does not affect that.
Comment: When the vaccination policy was announced, SecDef Cohen set four
conditions before the policy was to be implemented. One of those
conditions was “supplemental testing to assure sterility, safety, potency
and purity of the vaccine.” DOD allowed Bioport to perform the testing
even though the FDA had threatened the vaccine manufacturer in March 1997
with a revocation of their license. DOD hired a non-pharmaceutical defense
contractor to oversee testing by the manufacturer. In his April 1999
testimony, the anthrax vaccine program manager, BG Eddie Cain, admitted to
“inconsistencies” in the supplemental testing procedure. He stated: “based
on this inconsistency, JPOBD suspended supplemental testing and sent a
"Tiger Team" of subject matter experts to help resolve the problem.
Corrective action is being implemented. We expect to resume testing within
six months.” This admission of “inconsistencies” by DOD’s program managers
means that the supplemental testing performed on anthrax vaccine used on
servicemembers is of questionable value.
Additionally, on 29 Apr 99 the GAO reported to Congress that anthrax
vaccine “quality cannot be guaranteed from final tests on random samples
but only from a combination of in- process tests, end- product tests, and
strict controls of the entire manufacturing process.” Therefore,
supplemental testing, even if without “inconsistencies” admitted to by
DOD, cannot compensate for a flawed manufacturing process revealed by FDA
inspections and documented by the GAO.
Q: Are there other strains of anthrax that you can -- as a weapons
designer -- you slightly alter that and therefore bypass your vaccine?
A: There are a couple of answers to that. One is, it's theoretically
possible to alter anthrax so that our vaccine would not be effective
against it. It's theoretically possible. Nobody has one that we know of.
Comment: On 5 Apr 1999 the New York Times reported on a recent book by a
defector and former deputy director of the Soviet germ-warfare program,
Ken Alibek. He stated anthrax “was genetically altered…to resist five
kinds of antibiotics.” Additionally, a November 1998 Nation Magazine
article reported, “at the end of 1997 Russian scientists had published a
paper in the British medical journal Vaccine describing the creation of a
genetically engineered anthrax strain that was resistant to standard
Russian anthrax vaccine.” Alibek stated in another interview: “Vaccines
are not the answer.”
Q: Are there more severe [reactions] than that? Are there people who are
crippled because of this? Are there people who...
A: We're not aware of anyone who's crippled...It's on the order of three
to five people.
Comment: This admission contradicts statements about the vaccine by Mr.
Bacon, who said last January, “It’s safe and reliable…It works and has no
side effects.” This admission also contradicts DOD’s anthrax website,
which states: “No reports of serious adverse effects have been received by
the manufacturer” – unless DOD is not reporting adverse reactions to the
manufacturer. If DOD is not, then it is in violation of federal rules (21
CFR 600.80), as is the manufacturer, if it does not promptly report
adverse reactions to the FDA. Further, servicemembers are getting
seriously ill – and some have testified before Congress.
Q: So what percentage of the people who are getting the shots are coming
up with some sort of reaction on their arm? Twenty percent, 40 percent?
A: The data I'm aware of would say closer to the order of 40 to 50 percent
would have something. They'll have some soreness, redness. The number that
are going to have systemic illness with fevers, they're going to have to
be hospitalized, are still extremely small. Much less than 40 to 50
percent.
Q: So 100, 1,000 people out of your million shots, out of your 320,000?
A: I don't have a number for you of that order. We looked at two small
subsets. The numbers that have got fevers were probably in the 7 to 10
percent...
Comment: DOD’s vaccine tracking system does not track adverse reactions –
they rely on servicemembers to send a form to the FDA. In March, the
Assistant Secretary of Defense for Health Affairs testified, “there have
been 42 Vaccine Adverse Event Reporting System (VAERS) reports submitted
to the FDA and CDC (an adverse reaction rate of 0.007 percent).” However,
low reporting of adverse reactions may be because “initially patients who
reported their illnesses as potentially related to the anthrax vaccine
were viewed as "malingerers", "whiners"," liars" and "hypochondriacs,”
according to Congressional testimony by a career medical officer in June.
At the 5 Aug 1999 briefing, senior officers admitted, “as we have gained
experience, we have found that those sort of local, self-limited, and
actually harmless reactions are much higher than we thought.” Despite
characterizations of reactions as “harmless”, the briefing made clear that
DOD implemented the anthrax vaccination policy without ever having studied
the long-term effects of the vaccine on servicemembers, and therefore they
have no statistical basis of asserting a vaccine reaction is “harmless.”
Q: What is your latest statistic on how many servicemembers have refused
the vaccine?
A: We don't have a formal tracking mechanism where we query and require
commanders in the field to report back to us the numbers. [and later] Mr.
Bacon: The answer is I'm not aware that any specific... We have
approximately 200 people out of 320,000 who have received this vaccine
have come into the disciplinary system. It's a small number.
Comment: After an admission by a military officer that DOD has no way to
track refusals or the retention impact of the anthrax vaccine policy, Mr.
Bacon gave a very carefully worded follow-up by limiting his response to
address only those servicemembers who “have come into the disciplinary
system.” This omits discussion of those who are forced out of the military
with a less than honorable discharge in lieu of a court-martial, and those
who transfer, resign or retire before they have to refuse.
Mr. Bacon: There is some indication that, in fact, some soldiers have said
that they refused to take the vaccine because they didn't want to deploy
to some place such as Korea where they would be required to have this
vaccine.
Comment: Mr. Bacon has made similar assertions before. Yet DOD has never
presented any evidence to support this claim which ignores that fact that
many of the servicemembers who have been punished for refusing the vaccine
were already deployed overseas, including Marines on Okinawa and sailors
aboard the USS Constellation. Mr. Bacon did not explain why hundreds of
reservists, who as volunteers can resign at any time, and who have served
repeated overseas tours in the past, have chosen to leave specifically
when their units have required the anthrax vaccination.
Mr. Bacon’s comment appears to be part of a Pentagon effort to ridicule or
impugn loyal servicemembers, including combat veterans, who have
volunteered to serve their country. The official DOD anthrax website
newsletter states: “Much of the hand-wringing and bizarre allegations
about the vaccine is coming from a vocal minority of people who think the
"field" is where a farmer works and "Gortex" is one of the Power Rangers.”
In fact, many of those opposed to the anthrax vaccination policy are
combat veterans.
Q: ...on the Hill. You've got two pieces of legislation...
Mr. Bacon: We're not disciplining the people on the Hill.
Q: But you've got to deal with them. There are two pieces of legislation
introduced in the House, a growing number of cosponsors. And they're
holding more and more hearings…
Mr. Bacon: …To make vaccine use voluntary would be irresponsible …
Comment: Apparently, more and more “irresponsible” Congressmen disagree
with Mr. Bacon. Rep. Walter Jones (R-NC) has introduced H.R. 2543 seeking
to make the vaccine voluntary. Rep. Benjamin Gilman (R-NY) has introduced
H.R. 2548 seeking a halt to anthrax vaccinations pending an investigation
by the National Institutes of Health. Rep. Gilman’s bill had 17 cosponsors
as of late August. Rep. Jack Metcalf (R-WA) has written SecDef Cohen
requesting DOD fund research into possible links between the anthrax
vaccine and Gulf War Illness investigated by the GAO and reported in
Insight Magazine.
More Congressmen are getting involved because they are hearing from their
constituents. If you have an opinion about the DOD mandatory Anthrax
Vaccination Immunization Policy we urge you to contact your Congressional
Representative and Senators now to let them know your thoughts.
Congressional staffers inform us that letters and telephone calls are
taken more seriously than email messages.
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