Aventis to Donate Smallpox Vaccine
Aventis announced March 29,2002
that it will donate 85 million doses of 40-year-old smallpox vaccine to the
Department of Health and Human services. After five months of "secret
negotiations," the France-based vaccine manufacturer has decided to "donate"
its stock to the U.S. government at no charge.
Current government policy calls
for stockpiling doses of smallpox vaccine in case an outbreak occurs. If one
case occurs anywhere in the U.S., public health officials will descend upon
that community, isolating the patient and vaccinating "rings" of contacts
around the infected person, beginning first with the people closest to the
victim.
D.A. Henderson, a Baltimore
physician who led the smallpox eradication effort and now runs the federal
Office of Public Health Preparedness, said that because the vaccine is
effective within four days of exposure and because the current threat of
attack is low, the risks still outweigh the benefits and the current policy
is reasonable. However, since a larger supply of vaccine has become
available, the Bush administration is reevaluating that position.
Although Health and Social
Services (HSS) and the CDC have known about the stockpile for months, Tommy
Thompson, the head of HSS, says that the vaccine was kept secret until
officials could determine whether it was "still good." He said, "There was
no sense heightening expectations of the American people" if the vaccine did
not pass muster. Apparently it has.
The Aventis vaccine is similar
to the 15.4 million doses of smallpox vaccine known as Dryvax (made by Wyeth)
that is already part of the government stockpile. Both vaccines were grown
from the same seed stock and both were made using calf skins.
On Thursday, federal
researchers announced that the Dryvax vaccine could safely be diluted
fivefold. Yesterday (3-29-02), Thompson and Henderson predicted that the
Aventis vaccine will be equally potent.
All indications are that the
Aventis vaccine is safe and effective. Over the next 6-8 weeks, the National
Institute of Health (NIH) will conduct clinical trials and then perform
dilution tests. Aventis, which is still finalizing its agreement with the
government, estimates that its vaccine is worth $150 million.
Washington Post March 30, 2002, pg. A02
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COMMENT By Dr. Sherri Tenpenny: |
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Does the idea of a European
drug company "donating" $150 million dollars worth of product as an
"insurance policy" for the American people sound a bit suspicious? Five
months of "secret negotiations" were engaged prior to this decision. Why did
an act of charity necessitate "secret" discussions? Was this an act of
generous altruism or did the company get something substantial in return?
It appears that Aventis may
be the winner here. One significant assurance negotiated in the favor of the
drug company was relief from product liability. When testing begins, Aventis
will be immune from any lawsuits that may arise in the wake of side effects.
In addition, Aventis has
been given the green light to enter the US smallpox vaccine market. A press
release posted on the Aventis website at the same time as the public
announcement of the donation states that Aventis will begin producing a new
smallpox vaccine using its proprietary, highly attenuated vaccinia virus,
called NYVAC™. The company stated that, "the NYVAC approach could
potentially be used as a next generation smallpox vaccine, should a broader
immunization effort be contemplated." If the old stuff doesn't work, there
is "new stuff" in the pipeline.
Aventis can now compete
directly with Acambis, another European vaccine manufacturer. Acambis was
rewarded two US Government contracts totaling $771 million to develop 209
million doses of smallpox vaccine by the end of 2002. The amount of funds
allocated toward Aventis' new vaccine project was undisclosed. However, it
would be interesting to know if the dollar amount of product donated to the
US will be off set by a promise to purchase an equivalent amount ($150M) of
the new vaccine, once it becomes available.
The article reports that the
Bush Administration is "facing growing public pressure" to reevaluate its
position on mass vaccination. Is the pubic really pushing for this vaccine,
or is the government eager to use a product that it just purchased for
nearly $1 billion?
In addition, the Washington
Post article reports that Vice President Cheney, Homeland Security Director
Tom Ridge and a few other select Pentagon officials are "developing
protocols" to determine who should be inoculated. Note that the people
making these decisions are not involved with health care. They are not
physicians---they are business men!!
The article goes on to state
that the "task force at the CDC" is scheduled to convene in May. This group,
called the Advisory Committee on Immunization Practices (ACIP), is the panel
of "experts" who make recommendations regarding the use of vaccines. Its
membership is nearly all medical doctors and the suggestions put forth by
this group are for the most part, universally accepted and implemented.
However, the committee's
chairman, Dr. John Modlin, Professor of Pediatrics and Medicine Dartmouth
Medical School, admits that in the case of smallpox, the final suggestions
made by ACIP may be overridden. He states that, "the final decision [to mass
vaccinate] might be made by Mr. Thompson or President Bush.
This public policy decision
could result in disaster.
Many articles in both
medical journals and the popular press have warned that the smallpox vaccine
can have severe, even lethal, side effects. Considered to be "rare," these
serious complications are mostly dismissed. However, the Smallpox Consensus
Statement published in a 1999 JAMA article reveals that "if 1 million
persons were vaccinated, as many as 250 persons would experience adverse
reactions that would require the administration of VIG [vaccinia immune
globulin.]"
Notably, this antidote is
only used in cases of severe vaccine reactions. Doing the math, that's 1
severe reaction in every 4000 vaccinations. Considering that the CDC's
mandatory Vaccine Information Sheets (VIS)-which are required by law to be
given with each vaccine-state that severe reactions are "rare" or "as seldom
as 1 in a million," the acknowledgment of a possible severe reaction rate of
1 in 4000 is extremely significant.
There are six different
known complications and side effects associated with the smallpox vaccine.
The most serious complication, post-vaccine encephalitis, can result in
neurological damage or death. There is no treatment for this side effect and
VIG is ineffective. Data taken from a 1968 CDC report reveals that this type
of reaction was observed in 1 in 300,000 vaccines. This means that if 250
million people were vaccinated, there would be 833 cases of post-vaccine
encephalitis related brain damage or death. Apparently, that is the
government's definition of "rare." Compare this to the recently recalled
drug, Baycol, which was removed from the market because it was linked to 52
deaths.
A second known vaccine
complication is vaccinia gangrenosa. This side effect begins when the
initial vaccine site fails to heal. A progressive necrosis, or decay, of the
skin adjacent to the vaccination site develops, subsequently spreading to
nearby bones and then to internal organs. This severe vaccine reaction also
is frequently fatal.
The other types of
non-lethal vaccine complications include 1) vaccine-induced eczema, 2)
inadvertent auto-innoculation from the original vaccine site to other
locations, and 3) "generalized vaccinia", which is essentially a mild case
of "smallpox." In addition, there are many different vaccine-induced rashes
reported including erythema multiforme, a type of rash associated with
autoimmune problems. This suggests that the vaccine can cause ongoing immune
system disruption.
Considering that the chance
of a smallpox attack is highly speculative, is it worth potentially killing
or harming hundreds of people to protect the nation against a "threat" that
may not materialize?
The only known treatment for
smallpox vaccine complications is vaccinia immune globulin (VIG). VIG is
made from the serum of those who have been vaccinated with the smallpox
vaccine. Since smallpox vaccination ceased in 1972, the supply of VIG is
severely limited.
The article states that
"over the next six to eight weeks, the NIH will conduct clinical trials on
the [frozen] Aventis vaccine and then perform dilution tests." These
investigations will serve a dual purpose:
(1) test for side effects
and reactions, since the vaccine has never been tested in humans and
(2) create a pool of people
with antibodies to these vaccines, so that VIG can be "harvested" for use
when the mass vaccination program begins.
Based on these recent
developments, it appears that mass vaccination of the citizens of the United
States may be eminent, as everything is falling in to place:
-The Model State Emergency
Health Powers Act, with its mandatory vaccination provisions, is rolling
through state legislatures, seemingly unstoppable.
-Nearly $1billion has been
awarded to Acambis, Baxter and Aventis to bring the total supply of smallpox
vaccine to nearly 300 million doses by the end of 2002, enough to fulfill
HHS Secretary Tommy Thompson's vision that "every man, woman and child will
have a vaccine with their name on it."
With these provisions in
place, will we be able to avoid vaccination if we choose?
And, if we DO choose to
vaccinate, will we be protected from smallpox? Mass smallpox vaccination is
designed to protect us in the event of a bioterrorism attack. However,
smallpox is one of more than 65 available weapons of biological warfare. The
list includes viruses, bacteria, and toxins. Here is a partial list:
VIRUSES
· Congo-Crimean
haemorrhagic fever virus
· Dengue fever virus
· Hantaan virus
· Junin virus
· Lassa fever virus virus
· Ebola and other Marburg viruses
· Monkeypox virus
BACTERIA
· Coxiella burnetii (Q
fever)
· Brucella melitensis (Brucellosis)
· Clostridium botulinum (Botuism)
· Francisella tularensis (Tularemia)
TOXINS
· Botulinum toxin
· Clostridium toxin
· Aflatoxins
· Tetanus toxin
In addition, there are
countless numbers of agents that can be created through bioengineering
combinations of these organisms. In fact, the smallpox virus itself can be
engineered to contain botuliunum toxin and other compounds. The smallpox
virus has been genetically engineered with the following viruses here in
U.S. labs: flu, herpes, hepatitis B, rabies and HIV. None of the existing
smallpox vaccines would protect against these combinations.
Upon analyzing this list, what is conspicuously obvious is that vaccines are
not available to "protect" against most of these agents and many of them are
far more deadly than smallpox. The point is that, even though smallpox (and
anthrax) are considered by the US government to be the "most likely"
biological warfare agents, perhaps the media-generated hysteria surrounding
mass vaccination is simply because we HAVE a vaccine for these two agents.
If you were a "terrorist",
would smallpox be your "bug of choice?"
Contact:
Address:
New Medical
Awareness Seminars, LLC
c/o 13550 Falling Water Rd #202
Strongsville, Ohio 44136
Phone:
440-268-0897
Website:
www.osteomed.com
References:
Reuters: [website]
Aventis: [website]
Acambis: [website]
NYTimes,
March 29, 2002. Smallpox Vaccine Stockpile Is Larger Than Was Thought. [website]
JAMA, June
9, 1999; Vol. 281, No. 22, p 3132
Ibid. pg.
2134.
CNN report.
[website]
Microbiology 101 Internet Text, Chapt. XV: Biological Weapons, Malignant
Biology. [website]
MMWR June
22, 2001/50 (RR10), p. 8
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