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Safety of Anthrax Vaccine Debated
American Medicine News (The Newspaper for American Physicians ^ | March 6, 2000 | By Stephanie Stapleton, AMNews staff.

Posted on 10/14/2001 1:26:42 PM PDT by YaYa123

"Does the risk of biological weapons warrant widespread use of a vaccine that some link to the health problems associated with Gulf War exposures?

Washington -- Two years and more than 1.5 million doses into the process, Pentagon officials rejected a scathing congressional report calling on the Dept. of Defense to suspend its controversial Anthrax Vaccine Immunization Program. The report recommended treating the vaccine as experimental, making its use optional, and accelerating efforts to develop an improved version of "biologic armor."

Since 1998, the Defense Dept. has had in place a plan to phase in mandatory vaccination of the entire military force -- 2.4 million troops -- against anthrax, a bacterial disease that can be aerosolized and used as a weapon. So far, more than 400,000 military personnel have received at least one dose of the six-shot regimen.

"We have a very safe and effective vaccine against a very deadly biologic agent that we know to be in the hands of many of our adversaries and could be used against our forces," said Sue Bailey, DO, assistant secretary of defense health affairs. "Were they not vaccinated and exposed to this agent, they would die a horrible death. It is our mission to protect these forces."

Still, this mission has faced skepticism since its start The vaccine has been refused by 351 soldiers, who've chosen instead to face potential court martial or administrative punishment. In most cases, they're afraid about possible unknown side effects and continued distrust stemming from past troop exposures to substances ranging from Agent Orange to Gulf War vaccines and treatments.

Lawmakers have increasingly echoed their questions, asking if the risk of the vaccine may be greater than the risk of being exposed to anthrax. And, though the report has no binding impact on the AVIP program, the vaccine's supporters worry it'll add momentum to legislative proposals to stop it.

Since American troops entered Kuwait and Iraq during the Gulf War, concern about biological weapons has grown significantly. Pentagon officials estimate at least 10 nations, including North Korea, have the capability to use anthrax. Based on this, Defense Secretary William Cohen announced a total force immunization initiative in 1997, with the actual vaccination process beginning in 1998.

The vaccine itself gained Food and Drug Administration approval in 1970 and again in 1985 for use against anthrax contracted through the skin. However, because no clinical studies could be ethically conducted involving the very deadly inhaled version of the bacteria, conclusive efficacy data do not exist for this indication. However, many experts cite evidence from nonhuman primate studies as sufficient support for its use.

Still, safety and efficacy questions are at the crux of criticisms outlined in the House Subcommittee on National Security, Veterans Affairs and International Relations' report.

"Because the anthrax vaccine is being studied as a potential causative or contributing factor in Gulf War veterans' illnesses, any expanded use of the same vaccine by DOD should be undertaken only with the greatest care," noted the report. It opposed continued widespread use, instead recommending the current vaccine be considered an off-label use because its actual license is for cutaneous, not inhaled, anthrax. The subcommittee's bottom line: no one should be forced to have the vaccine, and only those who give informed consent should be immunized. In other words, the mandatory program should be halted and research on a new vaccine emphasized.

According to a Defense Dept. fact sheet, however, these recommendations are flawed. There is nothing "experimental" or "investigational" about the anthrax vaccine, it states, adding that total force protection is necessary to ensure the success of missions. And, though department officials agreed on the importance of continued research, scientific advances take time. "We've got troops that are in danger ... today," said Marine Maj. Gen. Randy L. West, special adviser to the secretary of defense for anthrax and bio-defense affairs. "We can't wait until we've got a new and improved vaccine to give them the protection they need."

Lingering distrust fuels opposition
But this harm sometimes is a lesser concern. Lingering suspicions regarding the military's handling of Gulf War illnesses are still fresh in the minds of many, and examples of adverse events fuel their position.

The Defense Dept., though, points out that actual numbers do not bear out claims of widespread problems. The Vaccine Adverse Event Reporting System has gotten 620 reports about AVIP. Of this total, 76 have been deemed "to appear to be related to the vaccine" -- a small number compared with the more than 1 million vaccine doses dispensed so far.

Both Dr. Bailey and West agreed that these numbers were consistent with expectations based on previous research studies and other commonly used vaccines. But the congressional panel took a more cynical view based on testimony from troops who said they suffered reactions but were discouraged from reporting them.

Capt. Michelle Pielz, a C-5 Galaxy pilot from Dover Air Force Base, developed chronic fatigue, dizziness, joint pain and other debilitating symptoms after taking the vaccine. Capt. Jon Richter, another C-5 pilot, suffered chronic joint pain after receiving two inoculation doses. Because doctors could not definitely attribute his condition to the vaccine, no waiver was offered and he was ordered to take another shot.

"The vaccine may be as safe as many other approved products, but valid data to support, or refute, that proposition will not come from the AVIP," charged the report. "Preposterously low adverse report rates generated by DOD point to a program more concerned with public relations than effective force protection or the practice of medicine."

In the meantime, the planned expansion of the AVIP program is on hold. Defense Dept. officials said final clearance is likely to occur in September, when vaccine production can begin. In the meantime, only troops deployed to high-risk areas are getting the shots."

I'm sure all us news junkies have seen Sue Bailey on television, she's every network's resident expert on anthrax. In the Clinton administration, she was DOD's expert on the anthrax vaccine for our military.

Here's part of a DOD Bailey statement to the media, from back in 1998.

Sue Bailey: "As I've indicated, anthrax is a significant battlefield threat. We have particular concern because it is easily weaponized into an aerosol form that leads to the disease, inhalation anthrax. Inhalation anthrax, as opposed to the two other forms of anthrax -- which are the form cutaneous anthrax and intestinal anthrax -- the aerosol-induced inhalation anthrax is 99 percent lethal, so that, following symptomatology after exposure, it is 99 percent lethal."

You can read all of it here:
http://www.usembassy.ro/USIS/Washington-File/500/98-08-14/eur512.htm


TOPICS: Government; News/Current Events
KEYWORDS:
I listened to Sue Bailey and Dr. Bob Arnett disagree with each other on anthrax, one night last week on Geraldo. She said anthrax vaccination for the general population wouldn't be feasible. No one asked why the vaccine,(a 6 shot regimen), instead of the antibiotic treatment, was prescribed for the military. I don't pretend to understand half what they are saying about the disease, or about the preferred cures, but I do see a difference in Bailey's message in 1998, and what she's saying now. Back then, to justify the military receiving the anthrax vaccine, she said anthrax was EASILY aerosoled, now she says it's very difficult. Don't you just hate it when government officials are caught lying?
1 posted on 10/14/2001 1:26:42 PM PDT by YaYa123 (yaya123@aol.com)
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To: YaYa123; backhoe; ratcat; Lady GOP
They all lie and are pathetic. Myers, Bailey etc. I hope they get what they deserve.

Herald Sun Sunday Edition:

We're ready for germs

By ROBYN RILEY, Medical reporter
14oct01

AUSTRALIA is as prepared as it can be for biological or chemical terror attacks, experts say.

But Australians will not be offered vaccines against anthrax, smallpox or the bubonic plague as a precaution.

Australia's acting chief medical officer, Professor John Mathews, said no country had enough vaccines stockpiled to immunise entire populations.

Infectious diseases experts say it would be useless to try – because many of the vaccines have serious side effects and some, like the one for the plague, need to be repeated every six months.

A limited supply of anthrax vaccine is available in Australia, but it should be given 18 months before exposure.

The 15 million doses of smallpox vaccines stockpiled in America were made years ago and are nearing their expiry dates.

Professor Mathews said the risk of a bioterrorism attack in Australia was small, but confirmed that authorities were prepared.

"Clearly you can not exclude a risk," he said. "But Australia has good preparations in place, which were updated for the Sydney Olympics last year."

He said major hospitals in all states had supplies of antibiotics to treat the five illnesses identified as possible agents for biochemical weapons – anthrax, smallpox, botulism, tularemia and the plague.

Professor Mathews said it would be difficult for terrorists to spread these infections to large numbers.

"The Florida incident last week confirmed that," he said. "People were exposed to anthrax, but it proved very hard to infect large numbers."

He said it would also be difficult for terrorists to spread smallpox on a large scale.

"And the plague would not spread in a population like Australia," Professor Mathews said.

"Botulism is one of the agents spoken about as a threat. But to produce enough toxin to distribute this widely would be, we believe, almost impossible."

Tularemia is very infectious, but can be treated with antibiotics.

"Certainly with what we know about these agents, the incidence would, at most, infect only a small number of people," Professor Mathews said.

He said no country in the world could be totally secure, or think the risk of germ warfare was zero.

"But Australians should be very reassured that long before September 11 we had in place a good system," he said. "And we are now re-examining all contingency plans."

A Victorian infectious diseases expert, Dr Tilman Ruff, said it was reasonable for Australians to be concerned about biological weapons.

But he said the risk was small and any attack would be localised "in a particular city or a contained area such as an office building".

Dr Ruff said prevention was the best way of eradicating the threat of bioterrorism.

"Frankly, there is very little one can do to mitigate the effects of germ warfare," Dr Tilman said. "In terms of immunising the population on a mass scale it would be too difficult, costly and there are risks."

Dr Ruff, director of vaccines for GlaxoSmithKline, said immunisation against anthrax and the plague had not been rigorously tested and may have considerable side effects.

"There were allegations that the anthrax vaccine caused what has become known as the Gulf War Syndrome," he said. "Many American military personnel suffered ill health and the vaccine may have been a cause. It is still being investigated."

Dr Ruff said smallpox vaccine had not been used routinely in Australia since 1974, so people under 25 have no immunity.

The last anthrax case in Victoria was in 1997 – a knackery worker who was treated with antibiotics and survived.

Dr Ruff said a nasty strain of influenza had the potential to kill millions. The Spanish flu pandemic of 1918 killed 20 million people, more than the number killed in World War I.

"(But) there is an influenza vaccine readily available here," Dr Ruff said.

Chemical warfare had its beginnings when mustard gas billowed into the trenches with horrifying effect in World War I. Since then military planners have factored defence against chemical agents into their battle plans.

Iraq is alleged to have used VX nerve gas to kill thousands of Kurdish rebels before and during the Gulf War.

In 1995, members of the Japanese Aum Shinrikyo sect released sarin nerve gas in a Tokyo subway, killing 12 people and making 6000 sick. They had planned to use anthrax, but could not get it into an aerosol form.

2 posted on 10/14/2001 1:38:32 PM PDT by DaRocksMom
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To: YaYa123
I wouldn't touch the stuff for me or my family. I'm sure many old-time Freepers are familiar with the many, many horror stories concerning forced anthrax vaccinations among the military under clinton. Unless things change, I wouldn't touch the stuff with a ten-foot pole.

On the other hand, I know that my wife and I and my older children are vaccinated against smallpox. When more vaccine is available, I wouldn't hesitate to vaccinate any of my children who got left out by mistake, or to recommend it for my grandchildren. Smallpox is potentially a much worse threat than anthrax, and the vaccine is throughly tested and proven.

3 posted on 10/14/2001 1:51:29 PM PDT by Cicero
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To: DaRocksMom; *Anthrax_Scare_List
Good info. There are reasons to be concerned about the military version of anthrax vaccines:

An incredible source paper on US Military policy [Free ...
... study calling for a DOD-funded study on the presence of antibodies to squalene (an
experimental, non-approved vaccine booster) in the blood of Gulf War Illness ...

Gee! I guess those Gulf War Vets weren't faking it after ...
... To: all. GAO Calls for Squalene Tests. By Paul M. Rodriguez. Although the Defense
Department denied having a role in the presence of the adjuvant squalene in the ...

Squalene found in military anthrax vaccine after numerous ...
... Squalene found in military anthrax vaccine after numerous denials Government News
Source: Militarycorruption.com Published: 7-13-01 Posted on 07/13/2001 08:09 ...

FEMALE SERGEANT DEAD FROM ANTHRAX SHOT - WHEN WILL PENTAGON ...
... Related Stories. MEDICAL EXAMINER LINKS DEATH TO ANTHRAX VACCINE. SQUALENE
CONFIRMED IN ANTHRAX VACCINE AFTER NUMEROUS PENTAGON DENIALS. ...

4 posted on 10/14/2001 2:07:08 PM PDT by backhoe
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To: ratcat
Just watching TODAY Show: Dr. Davud Satcher, US Surgeon General said on TODAY, in response to a question from Matt Lauer: The vaccine for the general population is not a viable option, first of all because it's not available to American physicians, and because there are some concerns about it's safety.
8 posted on 10/15/2001 4:27:16 AM PDT by YaYa123
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