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
| COMMENT By Dr. Sherri Tenpenny: |
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:
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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