Pentagon to resume forced anthrax vaccine program

By Kristin Roberts

WASHINGTON (Reuters) - The Pentagon on Monday said it will force troops in Iraq, Afghanistan and South Korea to be vaccinated against anthrax, restarting a court-halted program after U.S. regulators declared the shots safe and effective.

But William Winkenwerder, assistant secretary of defense for health affairs, said the Pentagon has no plans to vaccinate troops serving elsewhere, including those in the United States -- site of the only major anthrax attack against Americans, which killed five people in 2001.

"There are terrorists operating in and around Iraq and in that part of the world," Winkenwerder said. "That's a higher threat area."

The move to reopen the mandatory vaccination program follows a final order from the U.S. Food and Drug Administration in 2005 that found the anthrax vaccine safe and effective in preventing anthrax disease.

But attorneys whose lawsuit previously shut down the mandatory anthrax vaccination program said they plan to file a new suit to challenge its resumption.

"The forthcoming mandatory program is just as senseless as before and the FDA's new determination remains legally and scientifically flawed," said Mark Zaid, one of the attorneys.

Winkenwerder, who has not taken the anthrax vaccine, said the FDA's final order settles legal questions and the Pentagon is prepared for a court challenge.

Anthrax spores can be used in germ warfare to give victims the deadly bacterial disease. The Pentagon argues the shots are needed to protect troops against bioterrorism.

A federal district court in 2005 allowed the Pentagon to give some troops the vaccinations on a voluntary basis after ordering a halt to the mandatory shots the year before.

The court's action came after a lawsuit filed by six unnamed military personnel and civilian workers who objected to the vaccinations. Some troops had refused to get the mandatory shots due to worries about side effects, and some had been thrown out of the military.

Under the voluntary program, only 50 percent of troops offered the shot accepted it.

Winkenwerder said those numbers were too low and left U.S. forces unprepared for bioterrorist attacks. He said service members expect a shot to be mandatory if it is important.

More than 1.4 million service members have been vaccinated since 1998, according to the Defense Department.

Winkenwerder could not say how many troops would be vaccinated under the mandatory program, which should start in 30 to 60 days. Troop levels total 143,000 in Iraq, 21,000 in Afghanistan and 28,000 in South Korea.

Poisoning U.S. Troops: Anthrax, Lies and Vaccines, notes Heather Wokusch

2006-10-19 | The U.S. Defense Department quietly announced on Monday that mandatory anthrax vaccinations would resume for military personnel and civilians deploying to 28 countries across the globe and even for some based in the US. The Assistant Secretary of Defense for Health Affairs said, “Time and again (this vaccine) has been looked at by experts … and each time the conclusion is the vaccine is safe and it is effective.”

Tell that to the family of Jesse Lusian. The 24-year-old Northern Californian died last month “from complications resulting from an anthrax vaccine he received while serving our country as a Merchant Marine on a cargo ship in Diego Garcia, a Navy Support Facility in the Middle East.”

And tell it to Senior Airman Tom Colosimo, who suffered from fatigue, headaches and painful cysts after first being vaccinated in February 1998. Colosimo soon lost 50 pounds, had dangerous fainting spells and was diagnosed with anthrax intoxication, yet faced a “retaliatory” military when he tried to get medical care for his increasingly debilitating condition.

Tragic cases such as those of Lusian and Colosimo will become more commonplace when potentially hundreds of thousands of military personnel and civilians are soon forced to take the anthrax vaccine. There’s no excuse.

PLEASE CONTINUE.
http://www.heatherwokusch.com/index.php?name=News&file=article&sid=84

Soldiers are Sick of it!

Associated Press 10:20 AM Aug, 12, 2006

NEW YORK -- It takes at least 10 minutes and a large glass of orange juice to wash down all the pills -- morphine, methadone, a muscle relaxant, an antidepressant, a stool softener. Viagra for sexual dysfunction. Valium for his nerves.

Four hours later, Herbert Reed will swallow another 15 mg of morphine to cut the pain clenching every part of his body. He will do it twice more before the day is done.

Since he left a bombed-out train depot in Iraq, his gums bleed. There is more blood in his urine, and still more in his stool. Bright light hurts his eyes. A tumor has been removed from his thyroid. Rashes erupt everywhere, itching so badly they seem to live inside his skin. Migraines cleave his skull. His joints ache, grating like door hinges in need of oil.

There is something massively wrong with Herbert Reed, though no one is sure what it is. He believes he knows the cause, but he cannot convince anyone caring for him that the military's new favorite weapon has made him terrifyingly sick.

In the sprawling bureaucracy of the Department of Veterans Affairs, he has many caretakers. An internist, a neurologist, a pain-management specialist, a psychologist, an orthopedic surgeon and a dermatologist. He cannot function without his stupefying arsenal of medications, but they exact a high price.

"I'm just a zombie walking around," he says.

Reed believes depleted uranium has contaminated him and his life. He now walks point in a vitriolic war over the Pentagon's arsenal of it -- thousands of shells and hundreds of tanks coated with the metal that is radioactive, chemically toxic, and nearly twice as dense as lead.

A shell coated with depleted uranium pierces a tank like a hot knife through butter, exploding on impact into a charring inferno. As tank armor, it repels artillery assaults. It also leaves behind a fine radioactive dust with a half-life of 4.5 billion years.

Depleted uranium is the garbage left from producing enriched uranium for nuclear weapons and energy plants. It is 60 percent as radioactive as natural uranium. The United States has an estimated 1.5 billion pounds of it, sitting in hazardous waste storage sites across the country. Meaning it is plentiful and cheap as well as highly effective.

Reed says he unknowingly breathed DU dust while living with his unit in Samawah, Iraq. He was med-evaced out in July 2003, nearly unable to walk because of lightning-strike pains from herniated discs in his spine. Then began a strange series of symptoms he'd never experienced in his previously healthy life.

At Walter Reed Army Medical Center in Washington, D.C, he ran into a buddy from his unit. And another, and another, and in the tedium of hospital life between doctor visits and the dispensing of meds, they began to talk.

"We all had migraines. We all felt sick," Reed says. "The doctors said, 'It's all in your head.' "

Then the medic from their unit showed up. He too, was suffering. That made eight sick soldiers from the 442nd Military Police, an Army National Guard unit made up of mostly cops and correctional officers from the New York area.

But the medic knew something the others didn't. Dutch marines had taken over the abandoned train depot dubbed Camp Smitty, which was surrounded by tank skeletons, unexploded ordnance and shell casings. They'd brought radiation-detection devices. The readings were so hot, the Dutch set up camp in the middle of the desert rather than live in the station ruins.

"We got on the Internet," Reed said, "and we started researching depleted uranium."

Story continued on Page 2 »

Anthrax Vaccine for Servicemembers, legal status

In October 2004, federal district court judge Sullivan ruled that the anthrax vaccine had not undergone proper procedures for licensure, and made a previously temporary injunction prohibiting forced vaccinations, permanent. This effectively removed the vaccine's license.

In early 2005 DOD asked FDA and HHS for permission (an “Emergency Use” authorization—though DOD attorneys had informed Judge Sullivan there was no emergency) to continue to use the vaccine, although unlicensed, based on new legislation passed for bioterrorism emergencies or potential emergencies. Permission was granted, but the judge required that vaccinations be voluntary and not mandatory, as they had been, and that a copy of his ruling be placed in every clinic administering anthrax vaccine.

Subsequently, only about 10% of those persons asked to take the vaccine have done so voluntarily, and only a fraction of these complete the full course of inoculations. Similar data regarding acceptance rates for anthrax vaccinations in British troops, where vaccination has always been voluntary, has been published in two articles.

In December 2005, FDA issued a new “Final Rule” for anthrax vaccine, following a required comment period. FDA glossed over many of the scientific and legal concerns that were raised in the hundreds of comments received, claiming the vaccine was safe and effective.

On Sept. 7, 2006, after an appeals court had remanded the case back to Judge Sullivan, he refused to vacate his original order. This means that the vaccine was improperly licensed until FDA issued its Final Rule in December 2005. Vaccinations have remained voluntary. Those who were punished for refusing the vaccine may now seek to get their record reversed and might be able to be reinstated.

Evaluating and Treating the Illnesses Following Vaccinations

Thousands of vaccine recipients are still sick, and the military Vaccine Healthcare Centers have processed over 1200 persons who were seriously injured (putatively) by anthrax vaccine. The military has tried to remove funding for these centers over the past two funding cycles, but Congress has stepped in and guaranteed funding, so far. These centers were created by Congress to care for those with vaccine injuries, and they have developed considerable expertise in the evaluation of injured soldiers. Cures, however, remain a long way away, and little if any research is being done in this area. The Vaccine Healthcare Centers (at Walter Reed Army Medical Center in Washington, D.C.; Lackland Air Force Base in Texas; Portsmouth Naval Base, Virginia; and Fort Bragg, North Carolina) have yet to publish descriptions of the illnesses they are treating, and research they have performed. Because there are so few physicians who are knowledgeable about these illnesses, reservists, veterans and Merchant Mariners are all eligible for treatment at a military Vaccine Healthcare Center.

Disability Settlements

One case of a Merchant Marine who became disabled immediately following anthrax and smallpox vaccinations was settled early this year for about $2 million. I believe this is the only anthrax vaccine injury case to have been resolved. Only Merchant Mariners have the potential to sue over injuries (they can sue the shipping company that required the vaccinations under Maritime law), because the Feres Doctrine prevents soldiers from suing the U.S. government for injuries received "incident to military service."

“Licensed” Smallpox Vaccinations Still Mandatory

Although the smallpox vaccine program for civilians died, due to adverse reactions, after only 40,000 people were vaccinated, the vaccine is still mandatory in the military. Because no major legal effort has been undertaken to fight this vaccine, as was done for anthrax vaccine, it continues to be given to all U.S. soldiers deployed to Iraq, Afghanistan and possibly Korea. The military reports that over 1 million soldiers have been inoculated for smallpox since December 2002. There have been a number of cases of myo-pericarditis (inflammation of the heart) as a result. Some of these cases have gone on to develop heart failure. It is possible that some of the “mystery (noninfectious) pneumonia” cases that have occurred in Iraq and Afghanistan, and some of the non-combat deaths in soldiers deployed overseas are due to this vaccine complication.

Yet the military is using over twenty year-old, expired smallpox vaccine for its soldiers. Although FDA gave this expired product a license, FDA regulations say that expired product cannot be used, as it is considered adulterated. Were the smallpox vaccine license to be challenged in court, it would almost certainly be judged to have been licensed improperly, as happened for anthrax vaccine.

Mandatory Vaccinations for Civilians?

What should concern ordinary Americans is the purchase, by the Department of Health and Human Services, of 10 million doses of the military’s anthrax vaccine for the civilian stockpile, at a cost of $243 million. DHHS has additionally contracted to purchase 75 million doses of a similar vaccine for $877 million. Legislation proposed by Senator Richard Burr (R-NC) would create a new federal agency to oversee the development of new remedies for bioterrorism, but under a veil of secrecy greater than that granted the CIA.

Thus, very little may be known about the drugs and vaccines produced until an emergency arose. The products do not even have to be licensed by FDA to be stockpiled for use. Yet millions of Americans could be forced (under other recently passed bioterrorism legislation) to take such products.

Burr’s bill would give drug and vaccine manufacturers complete immunity from liability for injuries caused by the drugs and vaccines produced for the new agency. This would speed up drug and vaccine development, and decrease costs, since the manufacturers would not require liability insurance. However, it would result in a situation in which stockpiled drugs and vaccines may have undergone only very limited testing in humans, with unknown safety profiles and questionable effectiveness. When, in response to an emergency, they are used in millions of people, if severe side effects occur, those affected would have no legal recourse. They could not sue for damages or have their medical care covered.

I don’t think Americans who support this legislation understand the full implications of this. Over 100 million doses of smallpox vaccine have been contracted for by HHS, yet in a clinical trial conducted by the manufacturer, one in 145 recipients showed evidence of heart inflammation, when their blood was tested. Due to known severe side effects, HHS cancelled a trial of smallpox vaccine in toddlers. But if the government specifies that an emergency is developing, even newborns will receive smallpox vaccine.

A safer version of smallpox vaccine, Modified Vaccinia Ankara (MVA), should have been purchased instead. But the government is still deciding how many doses it wants of MVA, and current plans are to give it only to a small proportion of the population, those with damaged immune systems, pregnant women and possibly infants.

If the new federal agency is allowed to operate in complete secrecy, there may be little incentive to purchase the safest products available for the stockpile.

Meryl Nass, M.D.
September 23, 2006
MDI Hospital
Bar Harbor, Maine 04609

If you are thinking about going into the military, you need to know that after 9-11, Congress passed a law called Project Bioshield that gives the Secretary of Defense the power to order soldiers to take experimental vaccines without telling them they could die or be permanently injured and without getting their voluntary consent.  After 9-11, many states also passed laws that gave power to
government health officials to arrest and forcibly vaccinate
citizens without their informed consent.

Now Congress wants to pass another law that would give more power to government officials to declare a potential emergency – whether the emergency is real or not – and force you and every other American to take vaccines – whether they are experimental or not; without giving you a choice.  And without giving you the information you need about the vaccine’s side effects!  And if you get hurt, you won’t be able to go to court to find out if the drug company or the
doctor who gave you the vaccine could have done a better job
protecting you from harm. The soldiers hurt by the Anthrax Vaccine, just like the children hurt by the mandatory childhood vaccines, had no voice and had no choice.  If you want to make sure that you have the freedom to decide which vaccines you are wiling to risk your life for, you need to get informed, get involved and stand up for your rights, just like the band Anthrax is doing. -Barbara Loe Fisher, President and co-Founder of National Vaccine Information Center www.NVIC.org.

Holidays Huh?

As the holidays approach and Congress gets ready to adjourn, some
> Senators and Representatives in Congress with financial ties to the
> pharmaceutical industry are trying to pull a fast one on you and your
> family. These same politicians did the same thing in 2002 when they
> tried to
> sneak in liability protection for Big Pharma by inserting the
> thimerosal
> rider into the Homeland Security Bill.
>
> Last night, legislators writing the Department of Defense (DOD)
> Appropriations Bill slipped in language in the Conference Report AT
> THE LAST
> MINUTE giving vaccine manufacturers TOTAL LIABILITY protection if
> experimental vaccines injure or kill citizens whenever the Secretary of
> Health declares an "emergency." That "emergency" could include
> everything
> from a "potential" bioterrorism attack to a potentially bad flu year.
>
> And you may not have a choice about whether or not to take those
> experimental vaccines if your Governor follows the lead of the
> Secretary of
> Health, declares an "emergency" in your state and trots out the state
> militia to arrest, quarantine and forcibly vaccinate you and your
> family.
> Laws passed at the state and federal level since September 11, 2001
> allow
> all of this to happen (go to www.nvic.com and read a letter to Col.
> Robert
> P. Kadlec, M.D., a staffer to Senator Burr which summarizes state and
> federal legislation since 9-11.).
>
> But YOU can stand up TODAY and CALL YOUR OWN SENATOR AND
> CONGRESSPERSON
> and make your voice heard before it is too late. CALL NOW AND PROTECT
> YOURSELF AND YOUR LOVED ONES FROM BEING VICTIMIZED BY DRUG COMPANIES
> AND
> THEIR ALLIES WHO WANT TO ESCAPE ALL RESPONSIBILITY FOR VACCINE
> INJURIES AND
> DEATHS.
>
> To find out who your Senator is, go to www.senate.gov
> To find out who your Representative is go to www.house.gov .
>
> CALL YOUR SENATOR OR REPRESENTATIVE by dialing 202-224-3121.
>
> Every call or fax makes a difference. DON'T GIVE UP! OUR VOICES ARE
> BEING HEARD!
>
>
> http://search.csmonitor.com/search_content/1215/p13s02-uspo.html
> The Christian Science Monitor
> December 15, 2005 edition
>
> A measure to shield drug manufacturers from lawsuits in an effort to
> encourage them to develop new vaccines is likely to be quietly
> attached to a
> "must pass" defense appropriation bill within the next few days.
>
> If the US Secretary of Health and Human Services declares that
> vaccines were
> being distributed during a national health emergency, such as a flu
> pandemic, the bill would make it very difficult for people who felt
> they had
> been harmed by vaccines to pursue legal action against the
> manufacturer.
>
> A broad swath of consumer-rights groups and open-government advocates
> had
> succeeded in slowing the progress of a bill containing similar
> provisions
> sponsored by Sen. Richard Burr (R) of North Carolina. That measure,
> introduced in October, would also establish a Biomedical Advanced
> Research
> and Development Agency (BARDA) that critics say would be exempted from
> public and congressional scrutiny. Congressional staffers have been
> meeting
> with concerned groups, including a meeting planned for Wednesday, to
> revise
> Senator Burr's bill. A revised version isn't expected to be introduced
> until
> next year, though its future would be uncertain if the vaccine
> liability
> shield is enacted separately first.
>
> "It looks like the liability-protection language is in [the defense
> bill],
> which will be very difficult for [members of Congress] to vote
> against,"
> says Barbara Loe Fisher, president of the National Vaccine Information
> Center, a consumer watchdog group in Vienna, Va. Backers of the
> liability
> shield, led by Senate majority leader Bill Frist (R) of Tennessee,
> "were
> very smart in that strategy," says Ms. Fisher, who calls it "a threat
> to
> civil rights, to access to the judicial system, and to human rights."
>
> The possibility of an avian flu epidemic, as well as the use of
> biological
> weapons, have spurred interest in stepping up production of new
> vaccines.
> Shield-law proponents has argued for years that the world's giant
> drugmakers, so-called Big Pharma, would never take much interest in
> that
> arena until they were given strong protections against lawsuits.
>
> You "want to harness" Big Pharma "to really kick this thing off," says
> Christopher-Paul Milne, assistant director of the Center for the Study
> of
> Drug Development at Tufts University in Medford, Mass. "They have the
> resources and the expertise and the manufacturing capacity to get
> [development of new vaccines] done in a short period of time."
>
> Today, five or six big companies are making vaccines compared with
> more than
> 20 several decades ago, Dr. Milne says. "Some of that is because of the
> consolidation of the companies," he says, but some is the result of
> the high
> risk. To attract Big Pharma, "the potential rewards are going to have
> to be
> high," he says. In a national emergency, vaccines might have to be
> produced
> quickly, and perhaps without sufficient testing. In that kind of
> high-risk
> scenario, "you're talking about the need for liability protection," he
> says.
>
> Senator Burr's bill, the Biodefense and Pandemic Vaccine and Drug
> Development Act, would require plaintiffs to prove "willful
> misconduct" by
> drugmakers. " 'Willful misconduct' is usually pretty egregious
> activity,"
> Milne says. "It's going to be hard to sort all that out to a jury or a
> judge. It's a pretty high threshold."
>
> "I would have to prove some scientist at Merck or some CEO somewhere
> had
> made a determination to hurt me," said Chris Mather, a spokeswoman for
> the
> Association of Trial Lawyers for America, characterizing the bill to
> the
> Associated Press last month.
>
> If a liability shield is embedded in the defense bill, it may not
> contain
> secrecy provisions that raised strong protests from open-government
> advocacy
> groups. The Burr bill would nearly exempt BARDA from the Freedom of
> Information Act (FOIA) or the Federal Advisory Committee Act, which
> reports
> on the activities of government agencies.
>
> BARDA would also be screened from the kind of normal cost-accounting
> procedures other agencies must follow, says Pete Weitzel, coordinator
> of the
> Coalition of Journalists for Open Government, whose member
> organizations
> include the American Society of Newspaper Editors and the Society of
> Professional Journalists. Those groups, along with seven other CJOG
> members,
> signed a letter Nov. 3 asking that the secrecy measures be stripped
> from
> Burr's legislation.
>
> The level of secrecy that BARDA would operate under "is to the best of
> my
> knowledge unprecedented," Mr. Weitzel says. "I don't know of any other
> agency in the government that has been given that kind of authority."
> Even
> the CIA and the Defense Intelligence Agency are subject to some
> aspects of
> FOIA, he says.
>
> "[The Burr bill] was breathtaking in its scope in the way it wanted to
> completely exclude this new agency from FOIA," adds Lucy Dalglish,
> executive
> director of the Reporters Committee for Freedom of the Press.
>
> Rep. Dave Weldon (R) of Florida, a medical doctor, has been among those
> worried that too-strong liability protections for drugmakers might
> cause
> people to hesitate to take vaccines in the event of a pandemic. In
> 1976, the
> government's swine-flu vaccine program collapsed when public fears
> spread
> about potential harm from the vaccine.
>
> In a letter last week to congressional leaders, a group of a half-dozen
> consumer advocacy groups, including Public Citizen and the Consumer
> Federation of America, wrote: "Broadly shielding [drug] manufacturers
> from
> responsibility for gross negligence, recklessness, and other egregious
> behavior, and leaving victims with no recourse, may cause more public
> harm
> than the pandemic disease itself."

Latest Info

Interesting how when given a chance to comment for one of the stories, DoD could not be reached for comment - now that the FDA has again supported the criminal conduct, opinions now seem to fly - this is quite a lie Grabenstein made coming only two weeks apart.

In addition, if it is true that the anthrax vaccine is 'as safe as other vaccines', and if over 20,000 hospitalizations following the anthrax vaccine were not reported in a two-year period, then, what does this tell us on the safety of all vaccinations?

On Dec. 18th, '05, Grabenstein stated:
(See below for full editorial)

We use the scientific methods taught in America's best universities to assess vaccine safety and side effects. Reports to the national adverse-event database on the anthrax vaccine, as well as hospitalizations, were rigorously analyzed. Results showed that hospitalizations among anthrax-vaccinated troops and unvaccinated troops occurred at the same rate for the same diagnoses. I personally shared safety findings with Congress, the Food and Drug Administration and the public as the information accumulated.

On Dec. 4th, 2005, this was stated:

Col. John Grabenstein, director of the military's vaccine agency, said no one from the military intentionally misled Congress or the public. He said the 20,765 hospitalizations merely followed vaccinations in time, without documented proof of a cause-and-effect relationship.

He said a statistical analysis showed that those who'd been vaccinated weren't more likely to be hospitalized or likely to seek medical treatment than those in the military who hadn't been vaccinated from 1998 through 2000.

Some medical experts say this approach doesn't adequately address the problems of many people who report illnesses after anthrax vaccination. That's because the approach is limited to comparing rates of illness involving one symptom or disease - instead of the complex combination of symptoms and illnesses that many veterans report after getting their shots.

The data that the Daily Press used to document the underreporting of hospitalizations came from a report that Grabenstein supplied in response to the newspaper's request. It's never been made public until today.

It covers 1998 through 2000, when the Pentagon did detailed evaluations every three months to compare hospitalizations, clinic visits and medical treatment data for those who'd been vaccinated, compared with troops who hadn't. This quarterly analysis stopped and hasn't been done since, Grabenstein said.

The practice of not reporting all hospitalizations continues.

Quarterly analysis of the vaccine's effects ended just as the nation's only manufacturing site for the drug regained its license. That was in 2002, after federal inspections found many safety and other problems that prompted a shutdown and renovation that began in early 1998.

The decision to discontinue the quarterly health monitoring program means that the biggest gap in research about the vaccine remains: There are no systematic long-term studies of the health of those who've taken the drug. Most studies that the Pentagon cites as support for the vaccine's safety involve monitoring that lasted days to a few months.

Grabenstein said he decided to halt the quarterly studies after consulting the chairman of the Institute of Medicine panel and its staff, and with doctors affiliated with the military. He acknowledged that he didn't consult the general who ultimately was responsible for the anthrax program.

The chairman of the institute panel, Brian Strom, said he didn't recall what was discussed at the time about the quarterly reports. But he said, "I think they should continue to be using it," in case there's a problem.

Another panel member, Linda Cowan, said she's sure the committee expected quarterly reviews to continue and pointed to a number of the panel's recommendations and findings that she said clearly contradicted Grabenstein's interpretation of its report.


Grabenstein said those were among the reasons that the full number of hospitalizations was not reported. Another reason, he said, was that examinations of the data showed that if there were adverse effects from the vaccine, they were so infrequent, they weren't detectable by statistical analysis. Doing this type of analysis - instead of simply reporting the incidents to VAERS - provided a more definitive look at the health effects of the vaccine, he said. As a result, "we decided not to file" public reports about all hospitalizations, he said. Those considerations weren't relayed to Congress or the public.

In December 2003, Pentagon officials conducted a news conference to rebut a judge's ruling that the shots had been given illegally and that troops had been used as "guinea pigs." Grabenstein was asked whether he had "any data on the numbers of people who have had bad adverse reactions to the vaccine and would have required hospitalization."

He said that only 69 hospitalizations had been reported to VAERS for the anthrax vaccine from 1998 through 2000. A panel of civilian experts had analyzed each, he said, and decided that 11 were results of the shot. The 69 cases were "a complete, exhaustive list of what was reported," Grabenstein said.

Grabenstein told the Daily Press that his statement wasn't misleading. He said no one should expect all hospitalizations after vaccination to be reported to VAERS - despite the Pentagon's written policies - because the number included cases unrelated to the vaccine, sometimes years after vaccination.

The memo, "Policy for Reporting Adverse Events Associated With the Anthrax Vaccine," serves as the standing order for all military personnel. It reads: "For the purposes of reporting anthrax vaccine adverse events, a Form VAERS-1 must be completed and submitted using service reporting procedures for those events resulting in a hospital admission or time lost from duty for greater than 24 hours or for those events suspected to have resulted from contamination of a vaccine lot."

The memo lists additional circumstances requiring a report, but nothing that would permit excluding hospitalizations after vaccination. It refers to the Pentagon's formal regulations, which don't include the exclusions that Grabenstein cited.


Randi Airola
517-819-5926

http://www.dailypress.com/news/opinion/dp-38790sy0dec18,0,7576781.story?coll=dp-opinion-editorials
Letters to the editor: Anthrax shot is best protection for troops
December 18, 2005

The recent series in your paper on the anthrax vaccine does not accurately reflect the actions or intentions of the Defense Department. We care deeply about the health of U.S. service members and strive to provide the best care and protection possible. Vaccination is the best round-the-clock protection for people who could be attacked with anthrax spores.

We use the scientific methods taught in America's best universities to assess vaccine safety and side effects. Reports to the national adverse-event database on the anthrax vaccine, as well as hospitalizations, were rigorously analyzed. Results showed that hospitalizations among anthrax-vaccinated troops and unvaccinated troops occurred at the same rate for the same diagnoses. I personally shared safety findings with Congress, the Food and Drug Administration and the public as the information accumulated.

I encourage your readers to visit www.anthrax .mil, where details about all 20 safety studies are posted. The best single source is a 265-page report published by civilian physicians from the National Academy of Sciences in 2002. This report found anthrax vaccine to be as safe as other vaccines, a conclusion supported by the FDA.

While vaccines can in very rare instances cause serious health problems, vaccination remains one of the best ways to keep our children, our troops, our retirees and our entire military family healthy.

Col. John Grabenstein

Gulf veterans 'find it more difficult to conceive'

14/07/04 - Health section

Gulf veterans 'find it more difficult to conceive'

Soldiers who served in the first Gulf War are more likely to experience
problems trying to have a baby compared with other servicemen, research
revealed today.

A study of more than 40,000 men found a small increased risk of
infertility among Gulf veterans. Pregnancies among Gulf soldiers and
their partners also took longer to conceive, according to the study
published on bmj.com.

The research came as an independent inquiry was under way to
investigate illnesses among those deployed to the Gulf during the 1991
conflict.

The Ministry of Defence, which funded the study, has always denied the
existence of a so-called Gulf War Syndrome, insisting there was no
single cause of the illnesses suffered by veterans of the war.

Support groups claim about 6,000 veterans have suffered unexplained ill
health since the conflict, and more than 600 are said to have died.

The latest study, by researchers at the London School of Hygiene and
Tropical Medicine, questioned 24,379 male Gulf veterans, matched with a
comparison group of 18,439 other servicemen.

The team, led by Noreen Maconochie, found that 732 Gulf veterans (7%)
and 370 other servicemen (5%) had been to see a doctor over fertility
concerns since the Gulf War.

Using information from the soldiers, the researchers calculated that
failure to achieve a conception was 2.5% for Gulf veterans compared
with 1.7% among non-Gulf veterans.

Failure to achieve a live birth was also higher among those who served
in the Gulf - 3.4% compared with 2.3%.

Among the planned pregnancies, Gulf veterans took longer to conceive -
9.1% took more than a year compared with 7.8% of non-Gulf veterans.

The researchers said that the effect did not decline with the amount of
time since the war.

And it was not affected by whether the men had had children before the
war or not.

Vaccines against anthrax and the plague, nerve agents from Iraqi
chemical weapons storage facilities, pesticides and exposure to
pollution from burning oil wells have been cited as possible causes of
ill health in Gulf veterans.


Find this story at
http://www.dailymail.co.uk/pages/live/articles/health/healthmain.html?

Sick Individual Look Here!

As everyone has heard, the FDA has once again asserted that the anthrax vaccine is safe and effective - the fradulent battle continues. As always, per my guidelines, I'm once again requesting from those ill permission to use your information for legal, congressional and media purposes.
Whether you've responded "okay" before in the past or not, please continue to do so, so I'm not releasing anyone's information that you don't want released. To make sure our information is updated, please send me your permission as well as:


address (complete):
tel # (home):
tel # (cell):

email address:

dates of anthrax vaccine:

diagnosis/symptoms (dates, even if approximate):

VAERS report filed?:

By whom? (include dates, even if approximate):

DoD disability rating? (include dates, even if approximate):

VA disability rating? (include dates, even if approximate):



This message needs to go far and wide - we need a lot of responses. The above applies to anyone that can document that they received the anthrax vaccine (even GWV's) - as well as anyone that may have also received a "cocktail" of immunizations, as long as the anthrax vaccine can also be documented.



Please respond as soon as possible. As always, any questions, please feel free to email or call me.



Randi Airola

517-819-5926

www.anthraxvaccine.org

www.militarycorruption.com

20,000 who got anthrax shot were hospitalized

BY BOB EVANS

DAILY PRESS (NEWPORT NEWS, VA.)

NEWPORT NEWS, Va. — The Pentagon never told Congress about more than 20,000 hospitalizations involving troops who’d taken the anthrax vaccine, despite repeated promises that such cases would be publicly disclosed.

Instead, a parade of generals and Defense Department officials told Congress and the public that fewer than 100 people were hospi-talized or became seriously ill after receiving the shot from 1998 through 2000.

They also showed Congress written policies that required public reports to be filed for hospitalizations, serious illnesses and cases where someone missed 24 hours or more of duty.

But only a sliver of those cases were reported, while the rest were withheld from Congress and the public, records obtained by the Daily Press show.

Critics of the vaccine, veterans’ advocates and congressional staffers say the Pentagon’s deliberate low-balling of hospitalizations helped persuade Congress and the public that the vaccine was safe.

Keeping the actual number of illnesses secret contributed to a shorter list of government-recognized side effects for the drug, giving patients and physicians a false idea of what might constitute a vaccine-related illness or problem. Doctors are expected to know the full list of side effects and alert federal drug safety officials whenever they see a repeat of those symptoms.

Repeated evidence of the same adverse side effect after a vaccination is one of the most telling signs of a systematic problem with a drug or vaccine, as opposed to a coincidental relationship, vaccine safety experts say.

Lou Gehrig’s disease

During the Daily Press’ investigation of the vaccine and its effects, the newspaper found three cases of amyotrophic lateral sclerosis — ALS, or Lou Gehrig’s disease — that the military hadn’t reported. The disease destroys muscles and nerves, is always fatal and rarely hits people younger than 45.

One of the three cases involves Navy Capt. Denis Army of Virginia Beach, Va. Army died in 2000, after developing symptoms less than a week after his first anthrax vaccination — and a few days before his 45th birthday. His widow filed the first public acknowl-edgement of his death and its temporal connection to the vaccine this year. That occurred after she talked to a Daily Press reporter and learned that she could file a report with the federal Vaccine Adverse Event Reporting System, or VAERS.

Navy Petty Officer 2nd Class Kristin Shemeley died of ALS in 2001, at 29. Her symptoms began about two months after her third shot, a sworn legal document detailing her illness says.

Before Shemeley died, she spent 14 months in Walter Reed Army Medical Center in Washington, D.C., where she was regularly vis-ited by high-ranking military officers, said her mother, Ginger Shemeley of Quakertown, Pa. She says her daughter repeatedly told those generals and admirals that she was suffering because of the vaccine and even pleaded with one of them to stop giving it to troops. Several of those generals and admirals had promised Congress that such cases would be publicly reported to VAERS.

The military never filed a VAERS report on Kristin Shemeley. Ginger Shemeley filed one after her daughter died.

Col. John Grabenstein, director of the military’s vaccine agency, said no one from the military intentionally misled Congress or the public. He said the 20,765 hospitalizations merely followed vaccinations in time, without documented proof of a cause-and-effect relationship.

He said a statistical analysis showed that those who’d been vaccinated weren’t more likely to be hospitalized or likely to seek medi-cal treatment than those in the military who hadn’t been vaccinated from 1998 through 2000.

Some medical experts say this approach doesn’t adequately address the problems of many people who report illnesses after anthrax vaccination. That’s because the approach is limited to comparing rates of illness involving one symptom or disease — instead of the complex combination of symptoms and illnesses that many veterans report after getting their shots.

The data that the Daily Press used to document the underreporting of hospitalizations came from a report that Grabenstein supplied in response to the newspaper’s request. It had never been made public.

It covers 1998 through 2000, when the Pentagon did detailed evaluations every three months to compare hospitalizations, clinic vis-its and medical treatment data for those who’d been vaccinated, compared with troops who hadn’t. This quarterly analysis stopped and hasn’t been done since, Grabenstein said.

The practice of not reporting all hospitalizations continues.

Quarterly analysis of the vaccine’s effects ended just as the nation’s only manufacturing site for the drug regained its license. That was in 2002, after federal inspections found many safety and other problems that prompted a shutdown and renovation that began in early 1998.

The company’s current manufacturing techniques provide greater potency compared with earlier versions of the drug, said the Government Accountability Office, Congress’ investigative arm. The manufacturer, BioPort Inc., says there’s no difference in the drug made since 2002 that might cause health problems.

No long-term study

The decision to discontinue the quarterly health monitoring program means that the biggest gap in research about the vaccine re-mains: There are no systematic long-term studies of the health of those who’ve taken the drug. Most studies that the Pentagon cites as support for the vaccine’s safety involve monitoring that lasted days to a few months.

None lasted as long as five years, the minimum length of time recommended by a nationally recognized panel of scientists assem-bled by the Institute of Medicine in 2002. The institute is a nonprofit organization that provides expert advice to Congress and other government agencies.

After the quarterly reviews of the vaccine’s effects stopped, more than a million troops were forced to take the vaccine — until a federal judge ruled last year that the drug had never been adequately licensed for protection against anthrax use in warfare.

He ordered the military to make vaccination voluntary. The Pentagon is appealing that ruling. A decision is expected by February.

Grabenstein said he decided to halt the quarterly studies after consulting the chairman of the Institute of Medicine panel and its staff, and with doctors affiliated with the military. He acknowledged that he didn’t consult the general who ultimately was responsible for the anthrax program.

The chairman of the institute panel, Brian Strom, said he didn’t recall what was discussed at the time about the quarterly reports. But he said, “I think they should continue to be using it,” in case there’s a problem.

Another panel member, Linda Cowan, said she’s sure the committee expected quarterly reviews to continue and pointed to a num-ber of the panel’s recommendations and findings that she said clearly contradicted Grabenstein’s interpretation of its report.

Strom and Cowan emphasized that they thought the vaccine was still safe.

Beth Clay isn’t so sure. She directed the staff of Congress’ House Government Reform Committee investigation into the anthrax vaccine from 1998 to 2001. She continued working on the subject as a congressional staff member through 2003, after her Republican boss was no longer chairman of the committee.

Clay said the military’s decision not to report all the hospitalizations gave the public and Congress a rosier picture of the vaccine than it deserved.

“We were never given this data,” she said. “Had we seen this, the committee would have had significant questions” and would have demanded more information about the program.

After reviewing the report obtained by the Daily Press, Clay said it raised several questions about the vaccine’s safety. She said Con-gress was never told about the detailed level of data in the report but was assured regular monitoring of the vaccine and its health ef-fects would continue.

Terminating the quarterly reviews would seem to break those promises, she said. “It’s just appalling that they didn’t keep up with this,” she said.

New antibody shows promise as cure for anthrax

November 29, 2005

AUSTIN, Texas—A new anthrax antibody engineered by scientists at The University of Texas at Austin protects and defends against inhalation anthrax without the use of antibiotics and other more expensive antibodies.

The high-affinity antibody, an anthrax antitoxin, successfully eliminated both anthrax bacteria and its deadly toxins in animal tests. If future tests concur, this could be the first successful treatment for late-stage anthrax infection, even for an anthrax strain that has been designed to resist antibiotics.


Dr. Robert Mabry of the Iverson and Georgiou laboratory at The University of Texas at Austin has reformulated the anthrax antitoxin to make it last longer in the bloodstream.
Photo: Marsha Miller
The new antibody treatment, reported in the December issue of Infection and Immunity, is the result of collaboration between the labs of Dr. Brent Iverson and Dr. George Georgiou at The University of Texas at Austin and a research team led by Dr. Jean Patterson at the Southwest Foundation for Biomedical Research (SFBR) in San Antonio.

“What we have found is that you may not even need the antibiotics to beat anthrax,” says Iverson, professor of chemistry. He says that the new treatment “looks promising” and that it could lead to a simpler and cheaper way to treat anthrax. The new antibody is produced in bacterial cells, rather than the more expensive mammalian cell culture now used to produce anthrax antibodies.

Patterson, chair of the Department of Virology and Immunology at SFBR, adds, “A concern to national defense is that terrorists might design a strain of anthrax that is resistant to antibiotics, but this antitoxin could eliminate those concerns by providing an effective treatment that doesn’t require antibiotics.”

Anthrax infection is successfully treatable only in its early stages, when antibiotics can be used to kill anthrax bacteria. Before 2002, nothing was available to treat the large amounts of deadly toxin released by those bacteria, which is what leads to death in patients with late-stage anthrax infection.

In 2002, Iverson and Georgiou, a biomedical and chemical engineer, reported that their labs had developed a high-affinity, “sticky” antibody designed to bind with anthrax toxin and remove it from the body. This antibody was licensed to Elusys Theraputics, a New Jersey-based biopharmaceutical company, who turned it into a full immunoglobulin G (IgG). In trials, Elusys has found that the IgG protects test animals from anthrax when administered both before and after exposure to the disease.

Since those findings, Dr. Robert Mabry of the Iverson and Georgiou laboratory has reformulated the antitoxin to make it last longer in the bloodstream. Mabry also produced the antibody in bacterial culture, which could eliminate the need for complicated and expensive IgG production in mammalian cell culture. Drs. Jean Patterson and Ricardo Carrión at SFBR, along with veterinary staff from the SFBR Department of Comparative Medicine, have tested the re-engineered antibody with guinea pigs to determine if the antitoxin could protect against a true infection with anthrax spores.

“We expected the antitoxin to extend the lifespan of the infected animals,” says Patterson, “but since we did not couple it with antibiotics, we thought that the bacteria would continue to replicate, and the increasing amount of toxins would eventually overpower the treatment.”

In fact, results differed from the scientists’ expectations, leading to the serendipitous discovery that the antibody effectively eliminates both the toxin and the anthrax bacteria.

In two separate experiments conducted in SFBR’s biosafety level 4, maximum containment laboratory, researchers placed anthrax spores in the nasal passages of guinea pigs, mimicking exposure to inhalation anthrax. The doses were 250 to 625 times what would ordinarily be lethal to 50 percent of the animals. After 72 hours, the animals not treated with the antitoxin succumbed to the infection, but those that received the treatment were still healthy two and three weeks later.

“Day after day, we came into the lab to find the animals still healthy and happy,” Patterson said.

Upon examination of all the animals at the end of both experiments, scientists found no evidence of disease, with no or only trace amounts of anthrax residing in typical reservoirs for the bacteria, the lungs and spleen.

Iverson cautions it’s not yet clear that this antibody treatment is as effective as the IgG antibody produced by Elusys, and that he and his collaborators are doing more studies to confirm that.

The researchers also plan to conduct additional tests to determine how the antitoxin eliminates anthrax bacteria, which is still unknown. They have two hypotheses, which might both be part of the full story. One hypothesis is that the antitoxin somehow neutralizes anthrax bacteria and prevents it from replicating. The other looks to innate immunity, theorizing that since the high-affinity antibody clears the body of the deadly toxin, it allows the body’s initial immune response to successfully kill the anthrax bacteria on its own.

This research was sponsored by the National Institute for Allergy and Infectious Diseases and the U.S. Department of Defense.
For more information contact: Lee Clippard, The University of Texas at Austin, 512-232-0675; Julie Collins, SFBR, 210-258-9437.

U.S. asks court to impose anthrax shots

By Pete YostAssociated PressPublished December 2, 2005
WASHINGTON -- The Bush administration asked a federal appeals court Thursday to reinstate mandatory anthrax inoculations for many military personnel, while a lawyer for soldiers who refused the shots said anti-anthrax vaccine was never intended for the purpose the Pentagon is using it.The government is appealing a decision by U.S. District Judge Emmet Sullivan, who suspended anthrax vaccinations after he found fault in the Food and Drug Administration's process for approving the drug. A half-dozen unnamed members of the armed forces are challenging the Pentagon's program.Labeling for the anti-anthrax vaccine says it is for individuals with high-risk exposure such as veterinarians and certain industrial workers.Appeals Judge David Tatel asked why the portion of the definition regarding high-risk exposure isn't broad enough to cover members of the military.Because the government originally sharply restricted its use, replied John Michels, an attorney for the six members of the military who refused the shots."Nobody thought that this stuff was licensed for inhalation anthrax," Michels said.At issue is whether federal regulators limited the vaccine's use to combating anthrax spores transmitted by touch."The labeling does not include any limitation," Justice Department attorney Michael Raab told the judges.Since 1998, 1.2 million troops have been vaccinated against anthrax in six-shot regimens. Hundreds of service members had been punished or discharged for refusing them.In April, Sullivan said the Pentagon can resume giving anthrax vaccinations, but only to troops who volunteer for them.The vaccine is being given primarily to troops serving in Korea, the Middle East and South Asia, the Pentagon says. It will also go to soldiers who work in counterterrorism roles related to defense against biological weapons inside the United States.About one person in 100,000 has a serious adverse reaction to the vaccine, according to the Pentagon.Over the last six years, the vaccination program has been plagued by manufacturing problems and troop protests.Started in 1998 with the goal of vaccinating all 2.4 million members of the active and reserve military, the program was radically reduced after factory violations by the nation's sole anthrax vaccine manufacturer left a dwindling supply of the drug.Saying troops should not be used as "guinea pigs," Sullivan ruled in December 2003 that the FDA had never approved the vaccine and issued an order stopping its use on troops. A week later, the FDA approved the vaccine, and the shots were resumed, only to be halted again by Sullivan 13 months ago.