Vaccine A

Pentagon to resume forced anthrax vaccine program

2006-10-20T00:10:00.000-07:00

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

2006-10-19T23:54:00.000-07:00

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!

2006-10-19T23:53:00.000-07:00

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

2006-10-12T00:59:00.000-07:00

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

2005-12-21T12:57:00.000-08:00

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?

2005-12-21T09:38:00.000-08:00

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

2005-12-21T09:36:00.000-08:00

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'

2005-12-21T09:34:00.000-08:00

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!

2005-12-21T09:32:00.000-08:00

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

2005-12-11T06:42:00.000-08:00

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

2005-12-09T13:25:00.000-08:00

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

2005-12-02T18:55:00.000-08:00

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.

Is refusing a shot a crime?

2005-10-15T12:25:00.000-07:00

bevans@dailypress.com 247-4758
October 8, 2005

Marine Cpl. Ocean Rose refused an anthrax vaccination in 2001, after military doctors told him that EKGs after his first two shots indicated he was having heart attacks at age 20 for no apparent reason.Lt. Erick Enz, a Marine helicopter pilot and combat veteran of the 1991 Persian Gulf War, says he refused his shot in 2002, after hours of prayer, soul-searching and study about the vaccine convinced him that as a Christian, God didn't want him vaccinated with that drug.The same year, Sgt. James Muhammad - a Muslim and a Marine at Camp Lejune, N.C. - says he prayed and studied the Quran and medical reports, finally deciding that taking the anthrax vaccine would violate Allah's command to keep harmful substances out of his body.Their refusal to obey orders to take the vaccine was the only blot on their military records. Otherwise, they were gung-ho, exemplary Marines with careers on the rise, records show.Are these the people you'd want to keep tabs on as suspects for a violent or serious crime - or force to give up their right to privacy over their DNA? The government says yes and has ordered Enz, Rose, Muhammad and others who refused anthrax shots to submit blood samples for inclusion in the FBI's DNA database of criminal offenders. Refusal could mean further punishment - up to five years in prison, letters sent by military courts last month told them.A change in federal law and a decision by Secretary of Defense Donald Rumsfeld also add to the DNA database those people court-martialed for various offenses not found in the civilian world. They include fraternization, faking an illness to get out of work, showing disrespect to a superior officer or making a false statement when enlisting - even if it meant altering a birth certificate or other document so you could serve your country."It's completely preposterous," says Eugene Fidell, president of the National Institute of Military Justice. That's a group of lawyers and legal scholars dedicated to the study of military justice issues and educating the public about how the system works. "I can't think of a more asinine application of a federal law."The same law greatly expands the number and type of offenses that can trigger required donation of DNA from civilians, too. It pushes the boundary of the constitutional right of privacy that courts acknowledge regarding government demands for body fluids.This week, congressional, military, FBI and other government officials couldn't say how much these changes would cost taxpayers.The safety and effectiveness of the anthrax vaccination has been a hot topic in the military since the shots became mandatory in 1998. Hundreds of troops say the shots have brought them health problems, an allegation that the Pentagon adamantly denies. A federal judged ruled last year that the mandatory shots must stop because the vaccine was never licensed for its use in the military, allowing only voluntary inoculations.If Rose, Enz and the others refused to take the shots after his Oct. 27, 2004, ruling, they would not have been punished. The military has appealed the decision and wants to reinstate the mandatory shot program - along with punishments for refusal.John J. Michels is a former military lawyer who represents troops in that case. He says the military won't say how many have been court-martialed for refusing the vaccine since the program started, but he estimates that 100 to 150 were court-martialed and 400 to 500 more received other punishments. Some who refused weren't punished at all. That created a double standard that's now being compounded, he says.Taking DNA from someone isn't a minor matter, he says. Under the law, it's an invasion of privacy and can't be required without a clear government or public interest.Restrictions on government DNA collection is illustrated by laws governing the Pentagon's DNA database intended for use in identifying casualties. Everyone in the military for the past 10 years is included, but "civilian law enforcement has no access to casualty identification samples," says Maj. Michael Shavers, a Pentagon spokesman.As for the FBI database, he says Rumsfeld had no choice because Congress mandated that he include anyone convicted of an offense that is - at least in theory - punishable by a year or more in jail or prison. Refusing an order can bring a five-year sentence.When Congress enacted the Justice for All Act of 2004, it added dozens of additional civilian offenses to the list of crimes where DNA samples are taken. The changes expanded on the database's existing 2.7 million-sample collection of people convicted of murders, rapes, a variety of sex crimes, arson and other serious violent offenses. It added such crimes as "malicious mischief" on federal property, attempts to interfere with tax laws, violations of Pacific salmon and halibut fishing laws, and harming an animal used in law enforcement, among others.At the same time, Congress told the secretary of defense to consult the U.S. attorney general and develop a list of offenses "comparable" to the civilian crimes, the law says.Several lawyers who have looked into the issue say their reading of the law did give Rumsfeld a choice, but he didn't take it."It's pretty consistent with the mind-set that 'people who disobey orders will do anything, so get them all,' " says Michels, a former Air Force prosecutor who taught in the military's school for lawyers.The FBI and other police agencies use the DNA database to solve crimes and exonerate innocent people, often taking a simple drop of blood or sweat, or skin, and using it to solve a puzzling murder. DNA is basic genetic material and can be used to identify people to high degrees of certainty, though some scientists question whether the assumptions made in court cases are accurate and whether mistakes are being made that could convict innocent people.

more

Vaccine related to reservists death

2005-10-07T07:08:00.000-07:00

Panels Find Vaccines May Relate to Reservist's Illness, Death
The Department of Defense recently announced findings of two independent panels of medical experts who evaluated the possibility of a relationship between vaccination and the illnesses or deaths of four individuals. Among the four cases, the panels found only one case where vaccination may have contributed to an illness that led to death.
Both panels concluded that vaccinations may have triggered an illness that ultimately led to the death in April 2003 of Spc. Rachel Lacy, a 22-year-old Army Reservist, who received several vaccinations at the time she was mobilized for duty. The panels determined that evidence favored a causal relationship, but that the evidence was not conclusive. Each panel said that it was unable scientifically to identify a specific vaccination as the possible cause since several vaccinations were administered at one time.
In the review of the three other cases, the panels reviewed and found no association with vaccination in any of these cases. The patient diagnoses in these cases were: drug overdose, pulmonary embolism and atrial fibrillation.

Q&A - Vaccination Possible Cause of Soldier's Illness and Death
Q - What can you say about the role of vaccination in the death of Specialist Rachel Lacy?A - Two expert panels concluded that vaccination may have caused an illness that ultimately led to the death of Specialist Lacy. Neither panel could scientifically identify a specific vaccine.
Q - Will this finding of a likely association cause DoD to stop its vaccination programs?A - No. DoD will continue its vaccination programs.
more...
Learning from Adverse Events After Vaccination
The U.S. Army lost a valuable soldier in April 2003, a month after receiving five vaccinations during mobilization. Two independent panels of medical experts evaluated her case and concluded that vaccination may have triggered the lupus-like illness that ultimately led to her death, but that the evidence was not conclusive. Each panel said that it was unable scientifically to identify a specific vaccination as the possible trigger.

Help for Katrina

2005-09-07T07:49:00.000-07:00

As my duty as an American my heart goes out to the evacuees in LA, MS, Al. Please give to the redcross in order to help these victims.

Military Update: PTSD review is leaving many veterans stressed

2005-08-25T07:34:00.000-07:00

By Tom Philpott, Special to Stars and Stripes
Pacific edition, Thursday, August 25, 2005

Ronald Nesler of Las Cruces, N.M., a Vietnam veteran rated 100 percent disabled with post-traumatic stress disorder, learned this month that his case, as decided in 1997 by the Department of Veterans Affairs, lacked documents to support the finding of service-connected PTSD.

The VA regional office in Albuquerque advised Nesler in an Aug. 11 letter that he has 60 days to provide evidence he was exposed to the stressful wartime incidents described in his claim papers years ago.

“Otherwise, benefits, if confirmed entitlement is not established, may result in a change in your disability claims compensation,” the VA letter warned. The sentence was set off by bold-face and underlined type.

Nelser’s “permanent and total” disability award is suddenly at risk because of a VA inspector general review of 2,100 randomly-selected PTSD cases with 100 percent disability awards. The IG found that 25 percent, or 527 of them, lacked documents to verify veteran-reported evidence.

The IG review of PTSD cases was released in May, as part of a 200-page report on variances in VA disability compensation across the nation. Many more than 527 PTSD cases are at risk, however. The VA has announced it will review documents of 72,000 PTSD cases, those awarded 100 percent disability ratings from Oct. 1, 1999, through Sept. 30, 2004.

Over those five years, the number of veterans awarded compensation for PTSD jumped by 80 percent, from 120,000 cases in fiscal 1999 to 216,000. The planned review of the 72,000 cases likely won’t begin until January, said VA spokesman Scott Hogenson.

“Everybody talks about how PTSD is a very subjective diagnosis. This is not about diagnosis,” said Hogenson. “This is about collecting the empirical paperwork that says, ‘Yes, this individual was in this set of circumstances during this time in which these things happened, which may have led to posttraumatic stress.’”

Legitimate stressors in a veteran’s service jacket might be descriptions and dates of combat engagements or “de facto” stress indicators such as a Combat Infantry Badge or Purple Heart. The aim is to verify exposure to conditions that might leave a veteran with PTSD. The IG study suggested that claim examiners have been lax in demanding documents.

From 1999 to 2004, the IG said, PTSD payments jumped by 149 percent, from a $1.7 billion total a year to $4.3 billion. To show the potential cost of not seeking evidence of stressors in PTSD cases, the IG said a 25 percent error rate would have caused “questionable payments” of $860 million for VA in 2004 and $19.8 billion over those veterans’ lifetimes.

Nesler, who has a wife and handicapped step-daughter, receives PTSD compensation of a little more than $2,500 a month. He said VA officials have assured him that a decision to lower his PTSD rating would reflect a VA mistake. It should not raise suspicion of fraud. They also have assured him, though not in writing, that his VA compensation won’t fall. They do so, most likely, because Nesler has a 100 percent rating for prostate cancer. The VA presumes this cancer, if suffered by Vietnam veterans, presumably is from exposure to Agent Orange, a defoliant used widely during that war.

Nesler said his disability for cancer is not “permanent and total” like his PTSD award. He knows of many veterans treated for cancer who have seen their rating, and thus their pay, drop sharply following treatment.

A 1967 draftee, Nesler reached Vietnam in 1970. He served for 13 of his 14 months as a meteorological observer for B Battery, 6th Battalion, 32nd Artillery, part of the 1st Field Forces Vietnam.

The whole war experience was stressful, Nesler said, though his unit came under fire only seven or eight days while he was there. His most disturbing memories, he said, are of atrocities committed by soldiers. Nesler said he saw an American soldier detonate a directional mine toward a small bus, filled with Vietnamese women and children, near the town of Ninh Hua.

The incident, he said, was covered up but the screams and faces haunt him still. Nesler said he also feels guilt for not having filed an official incident report.

Nesler, a staff sergeant, was discharged in 1975 after eight years. He wasn’t feeling well and, as the years passed, he grew more anxious, had nightmares, insomnia and difficulty concentrating, all of which the VA later would tie to the war. In 1997, before VA approved his PTSD claim, Nesler gave to VA the names of a senior officer, two warrant officers and several senior enlisted soldiers who likely could verify the bus incident.

“I thought that was my proof,” he said. A VA official told him only recently that the names were never contacted. Still, the VA ruled in 1997, based on “unrefuted evidence,” that Nesler had served in a combat zone, had witnessed “a bus being bombed” and had a well-founded diagnosis of PTSD. It found “total occupational and social impairment” from a variety of symptoms.

Yet, Nesler said, he was in far better shape then than he is today.

“I have emphysema. I have cancer. I have a torn ligament in my shoulder. I have severe arthritis. I have PTSD … And I get this [letter] dropped in my lap. Right now my life is on hold till I find out what’s going to happen.”

If the VA experience with 2,100 PTSD cases is repeated in a review of 72,000 next year, one quarter of these vets, about 18,000, might feel their own stress levels rise as VA presses them to better document their claims.

Update on issues.

2005-08-25T07:20:00.000-07:00

I have recently started to compile a few records of folks that have come to my blog and I have actually, through the help of the resources I have gained, be able to help a few soldiers and families. Please note that in the strictest confidence you can contact me and I will direct you to a group of supporters that are willing to help you and I with nothing in it for them. I am trying to start a non profit organization so if you know of any that can invest or donate I have began a business plan. I would like to personally thank Dr Asa who has been key in assisting the affected people. I also am going to add POST TRAUMATIC STRESS DISORDER as a condition that I will assist veterans with. Please submit question to my email
hqvaccinea@yahoo.com.

That shot messed him up’

2005-08-10T16:11:00.000-07:00

Staff sergeant suspects effects of anthrax vaccine cut short his career

By Deborah Funk
Times staff writer

The walls are stripped bare, the furniture, pictures and awards are packed in storage, and the wheelbarrow and baskets overflowing with flowers that brightened the front yard have been given to neighbors.
All that’s left for Staff Sgt. Eddie Norman to do is go to the finance office, turn in his military ID card and map the route from Fort Meade, Md., to San Antonio. There, he said, he’ll go to the Department of Veterans Affairs for health care and rehabilitation. Where his wife and three children will receive care in Texas is not yet known.

After nearly 15 years of service, Norman is being medically separated — not retired — from the Army for debilitating muscle and joint pain, stiffness and weakness that started after his anthrax vaccinations.

He’ll get a lump-sum payout, which under the Army’s formula works out to $66,319.20, or 24 months’ basic pay.

He had sought at least a 30 percent disability rating so that he could keep his military health care, commissary and exchange benefits.

“They’re supposed to take care of me. They are accountable for what’s happened to me,” said Norman, 38. “They’re not being accountable. They’re not holding good leadership.”

Norman keeps folders labeled “VA,” “SSI” and others in a brown casual briefcase. His stack of medical records includes his medical evaluation board results and 10 diagnoses. Three of those conditions — musculoskeletal pain, sleep apnea and clinical depression — prevent him from meeting military medical-retention standards, according to the documents.

But the Physical Evaluation Board, part of the Army’s personnel system, said only the musculoskeletal pain made him unfit for service, and the board rated him 20 percent disabled for that condition. The physical evaluation process follows Defense Department policy.

“I used to be perfectly healthy,” Norman said, sitting on a box in his living room, his cane lying next to him. “The illnesses I have now occurred while I was on active duty.”

But just because a doctor determines a service member doesn’t meet medical-retention standards does not automatically mean the condition makes the member unfit for service. And the Physical Evaluation Board rates only those conditions deemed to make someone unfit. Officers and enlisted personnel are treated the same.

The board is a “performance-based system ... the mere presence of a medical condition that falls below medical-retention standards does not mean that condition is unfitting,” said Army Col. Frederick Schumacher, executive officer of the Army Physical Disability Agency.

“What the board does is take a look at the diagnoses, rates those that are listed as falling below retention standards and makes an independent determination if that condition itself leads to the physical unfitness of the soldier. If the answer to that is yes, it is rated. If the answer to that question is no, the condition is not rated,” Schumacher said. “This is established by law. The services only rate the unfitting conditions.”

Norman, a 1991 Persian Gulf War veteran, had some memory problems and muscle and joint pain in the mid-1990s, but recovered and was functional, scoring well on physical tests and completing classes, he said.

His muscle and joint pain flared and worsened after his anthrax vaccinations. He lost some muscle control in his hands and legs, he said, and has suffered depression over his physical condition.

Documents from military medical exams link the problem to the time of his anthrax shots, but cannot conclude the shots caused the problem. Vaccine health care experts say they have seen similar cases following vaccinations.

“Staff Sgt. Norman was a high-functioning, decorated service member prior to beginning anthrax vaccine,” stated a document from the Walter Reed National Vaccine Healthcare Center in Washington. “Staff Sgt. Norman’s life has been significantly altered due to his current disability and hope for recovery is uncertain. The lack of clinical findings is discouraging and leaves his providers baffled and powerless as to an effective treatment plan.”

According to the document, the Vaccine Healthcare Center has treated “many proficient service members with debilitating conditions that cannot be diagnosed or medically substantiated, conditions that have developed in close temporal association to having received the anthrax as well as other vaccines.”

Norman got all six anthrax shots under the mandatory program. He received his first while preparing for deployment to South Korea. Afterward, he said, his hips hurt and he couldn’t turn his neck. His health grew worse after each shot, he said, and he suffers from muscle cramps, numbness in his legs, ringing in his ears, poor sleep, diabetes and other problems.

“That shot messed him up,” his wife, Regina, said. “Before he could play with the children, jump rope, trampoline, everything. Now he can’t do those things with the kids.”

Norman would tell his daughters they could go to a friend’s house, forget he’d said it and then get angry when they weren’t home.

He still uses a cane to walk, wakes in pain sometimes in the middle of the night, and gets confused and frustrated. His legs hurt — especially his right leg, which, he said, shakes uncontrollably at times and “hurts terrible.”

The former light tactical wheel mechanic with the 1st Infantry Division hasn’t worked his job in more than three years. His involuntary separation because of permanent physical disability begins this month.

In San Antonio, the family will be closer to friends and extended family members. Norman said his next step is to see a VA rehabilitation counselor to learn what jobs he can do and try to go to vocational school.

“I feel like everything I really worked for is lost,” Norman said. “All my time in service, honorable time in service, that I worked hard for, is wasted.”

Soldier from Washington state dies at Fort McCoy

2005-07-14T08:50:00.000-07:00

Lee Newspapers

FORT McCOY, Wis. - A Washington state soldier training at Fort McCoy was pronounced dead Monday morning after being found unconscious in a barracks.

The soldier was at Fort McCoy for annual training with the 396th Combat Support Hospital of Vancouver, Wash., Public Affairs Officer Linda Fournier said.

The soldier's name is being withheld pending notification of next of kin. Fournier said the soldier's records were in Vancouver, and Fort McCoy officers were working with officials there to notify family.

The incident is under investigation, but Fournier said the death does not appear to be related to training activities.

This is the third soldier training at Fort McCoy to die in the past three years. In 2003, a female Army Reservist from Milwaukee died as a result of an undiagnosed medical condition that caused a deadly reaction to an anthrax vaccine. In August 2004, a member of the Minnesota National Guard unit died from a heart attack.

More than 130,000 soldiers train at the base each year. Fournier said the base's average daily population is 7,000.

Half of U.S. Military Personnel Refuse Anthrax Shot

2005-07-08T07:43:00.000-07:00

By David Ruppe
Global Security Newswire

WASHINGTON — Half of U.S. military and civilian personnel offered anthrax vaccinations under a voluntary program that began in May have refused the inoculation, according to figures released yesterday to Global Security Newswire by a Defense Department agency (see GSN, May 6).

Since May 19, the vaccine has been offered to about 14,000 personnel, and roughly 7,000 of them have refused to take it, according to Col. John Grabenstein, director of the Military Vaccine Agency.

No explanation was given for the high number of refusals. “We can’t speculate on individual decisions,” he said.

The current pace of vaccinations is expected to increase, he said, as additional clinic workers are certified to give the vaccine and additional military units offer treatments to personnel.

The high refusal rate comes amid persisting complaints by some service people and nongovernmental experts that the U.S. military has been reluctant to acknowledge a connection between the vaccine and uncommon but potentially debilitating side effects, which they say has hindered access to medical benefits and compensation (see GSN, Nov. 16, 2004).

It comes also despite a determination in December by then-Deputy Defense Secretary Paul Wolfowitz, citing classified intelligence, that there is “a significant potential for a military emergency involving a heightened risk” of an anthrax attack on U.S. forces.

Wolfowitz’s finding preceded the Food and Drug Administration’s granting of an emergency legal authority in January to give the vaccine voluntarily to service people. The vaccinations are focused on personnel stationed for prolonged periods in South Korea and the area of the U.S. Central Command, which includes the Middle East, along with those deployed for special biodefense-related missions.

“We are concerned that those who decline vaccination could die or be harmed if attacked with anthrax spores,” Grabenstein said.

The military has maintained that the vaccine is as safe as other commonly used vaccines, and Grabenstein said the recent treatments have produced only minor side effects.

“Adverse events are similar to previous experience, primarily temporary injection-site pain, swelling, or redness,” he said.

Steve Robinson, executive director of the National Gulf War Resource Center, however, said officials have been reluctant to acknowledge severe side effects that sometimes occur, making it difficult to obtain proper medical support.

The refusal rate, he said, suggests “that soldiers are not willing to take the risk if [the Defense Department] is not willing to provide medical care and compensation should they become injured.”

Approximately 1,200 military personnel were treated in 2003 and 2004 by four special clinics called Vaccine Healthcare Centers, for complex reactions to the anthrax or other military vaccines, the Army told Global Security Newswire this year (see GSN, May 6).

Mandatory Vaccinations Could Resume

The vaccinations began May 19. Under the voluntary program, personnel cannot be punished for refusing the vaccine.

A mandatory anthrax vaccination program that began months before the March 2003 invasion of Iraq and inoculated more than 1 million personnel was halted last October. The decision came after a federal judge ruled the vaccine could not be mandatory because the Food and Drug Administration had not licensed it as effective against inhalation anthrax, the type soldiers most be most likely to face in the field. Personnel who refused then were subject to possible removal from deployment status and disciplinary action.

A licensing decision is pending from the Food and Drug Administration for using the vaccine against inhalation anthrax, which could lead to renewed mandatory vaccinations. A final period for public comment ended in March.

The refusal rate appears to resemble that experienced by the voluntary anthrax vaccination program administered by the British government prior to and during the Iraq war. Statistics made public by the British Defense Ministry in February 2003 showed that as many as 49 percent of 20,000 military personnel offered anthrax vaccinations prior to the Iraq did not accept.

“The [Defense Ministry] is clearly losing the battle to convince the armed forces that anthrax infection is a clear and present danger in the Gulf,” MP Paul Keetch, Liberal Democrat shadow defense secretary, said then. “When weighing the risks of infection with fear of health complications from the vaccine, the majority of RAF [Royal Air Force] and naval personnel are rejecting vaccination.”

A former officer from the Royal British Legion, a charity supporting British service people and veterans, said in September 2004 that statistics indicated then that one-third of an estimated 45,000 British personnel involved in the invasion had refused anthrax vaccinations, according to a report by the Guardian.

A Canadian judge in May 2000 ruled Canadian military personnel could refuse the vaccinations without penalty, questioning that vaccine’s safety.

More than 40 Australian soldiers reportedly were recalled from Iraq around the time of the invasion for refusing anthrax vaccinations, though they reportedly were not disciplined.

The Bush administration justified the invasion of Iraq as necessary primarily for removing an alleged threat posed by a suspected Iraqi nuclear weapons program, and alleged chemical and biological weapons, including anthrax. A CIA-sponsored team concluded last year Iraq no longer had such weapons, having abandoned its banned programs after the 1991 Gulf War.

The terrorist network al-Qaeda is believed to have sought to use anthrax, but failed to obtain the agent or full capability for producing a weapon before it was routed from Afghanistan in late 2001.

A Defense Department report in 2001 alleged that North Korea had pursued biological weapons capabilities since the 1960s and possessed a rudimentary technical infrastructure capable of producing anthrax and other biological warfare agents. That same report alleged Iran had an active biological warfare program.

Anthrax mailings to several U.S. Senate offices and news media organizations in fall 2001 killed five people and sickened 22. No one has been caught.

GSN staff writer David Francis contributed to this article

One needs to wonder where COL. Grabenstein has been the past 6 + years, remarks made through entire article should almost be embarrassing.

1. RE: No explanation was given for the high number of refusals. “We can’t speculate on individual decisions,” he said.

This has been previously stated in GAO testament that IF the anthrax vaccination program was voluntary, there would be few takers, see: http://www.gao.gov/new.items/d02445.pdf; page 14 of the report for those that would not take the shot if voluntary; those who already left service, or had plans to BECAUSE OF AVIP begin on page 9.

2. Re: “We are concerned that those who decline vaccination could die or be harmed if attacked with anthrax spores,” Grabenstein said.

From the US Medical Research, Institute of Infectious Disease, Ft. Detrick, July 1998: (Email copy available on request – Thanks Z)

Treatment: Although effectiveness may be limited after symptoms are present, high dose antibiotic treatment with penicillin, ciprofloxacin, or doxycycline should be undertaken. Supportive therapy may be necessary.

PROPHYLAXIS

Vaccine: A licensed vaccine is derived from sterile culture fluid supernatant taken from an attenuated strain. The vaccination series consists of six 0.5 ml doses SC at 0, 2, and 4 weeks, then 6, 12 and 18 months, followed by yearly boosters. Limited human data suggest that the vaccine protects against cutaneous anthrax. There is insufficient data to know its efficacy against inhalational anthrax in humans, although studies in rhesus monkeys indicate that good protection can be afforded after only two doses (15 days apart) for up to 2 years.

3. Re: “The military has maintained that the vaccine is as safe as other commonly used vaccines, and Grabenstein said the recent treatments have produced only minor side effects.”

http://www.nti.org/d_newswire/issues/2005/5/6/325532e2-159e-459b-b667-4df3b804ebaf.html

Military Vaccines Trigger Special Treatment for 1,200

WASHINGTON — Approximately 1,200 U.S. military personnel who received vaccinations against biological agents during the past two years developed complex, in some cases debilitating, illnesses that were assessed or treated by a specialized network of clinics, according to figures released to Global Security Newswire by the U.S. Army and a review of some cases

http://www.nti.org/d_newswire/issues/2004/5/18/b047b91a-baae-4469-a369-ce894037d5a1.html

Since the headquarters center opened in 2001 at Walter Reed Army Medical Center in Washington, the network has evaluated more than 1,000 patients — military personnel, contractors and civilians — and counseled far more personnel — 139,000 in fiscal 2003 alone — by telephone and e-mail, according to Engler.

Suggestions have been made to close down some of the four centers, each of which has 12 clinical staff members, but the centers are overwhelmed, Engler said.

The network lately has been researching several cases of blistering skin rashes and oral ulcers, identified as the rare disease “pemphigus vulgarus,” occurring after anthrax vaccinations. It also is aiding investigations of at least 71 cases of myopericarditis occurring following smallpox vaccinations (see GSN, May 13).

Congress created the network following revelations in the late 1990s that the anthrax vaccine was causing a significant number of serious illnesses among military personnel, said Meryl Nass, another prominent military vaccine critic and physician who regularly treats soldiers with suspected vaccination complications.

“Congress pointed out that people, who were becoming ill following vaccinations, needed to be treated appropriately within the military, not just discharged because of their medical disability,” she said.

“We’ve briefed over the last few months numerous venues, and everyone says you’re doing a good job, we need you. … People continue to apologize to us and say we know you’re a good thing, we just don’t know how to pay for you,” she said. (COL. Engler)

http://www.bioportcorp.com/AnthraxVaccine/insert/avainsert.asp

Pregnancy
PREGNANCY CATEGORY D., See Warnings.

Approximately 6% of the reported events were listed as serious. Serious adverse events include those that result in death, hospitalization, permanent disability or are life-threatening. The serious adverse events most frequently reported were in the following body system categories: general disorders and administration site conditions, nervous system disorders, skin and subcutaneous tissue disorders, and musculoskeletal, connective tissue and bone disorders. Anaphylaxis and/or other generalized hypersensitivity reactions, as well as serious local reactions, were reported to occur occasionally following administration of BioThrax. None of these hypersensitivity reactions have been fatal.

Other infrequently reported serious adverse events that have occurred in persons who have received BioThrax have included: cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system.

Reports of fatalities included sudden cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system (CNS) lymphoma (1).

4. Re: The refusal rate, he said, suggests “that soldiers are not willing to take the risk if [the Defense Department] is not willing to provide medical care and compensation should they become injured.”

Unlike Waxman’s bill for civilians, see: http://www.nti.org/d_newswire/issues/2003/2/28/7s.html

WASHINGTON — Public health experts said this week that the single largest factor preventing implementation of the U.S. smallpox immunization plan is the lack of compensation for those sickened by the vaccine, but legislation is now being drafted to address the problem, according to congressional sources.

Waxman’s Bill

Waxman’s bill proposes a “no-fault compensation program modeled on the existing childhood Vaccine Injury Compensation Program. The purpose of this bill is to compensate people … for their un-reimbursed medical expenses and lost wages,” according to a summary of the bill released by Waxman’s office.

And Senator Gregg’s urging, see: http://www.nti.org/d_newswire/issues/2003/3/7/8s.html

The legislation would provide $262,100 to vaccine recipients, or their families, who die or suffer permanent disability. It would also provide limited compensation, after five missed days of work, for those who suffer less serious side effects.

“People should certainly sign up because this legislation is going to pass,” Gregg said.

Military personnel don’t quite have the same luxury of compensation for injuries incurred while on active duty (status all need to be on while being administered vaccinations), courtesy of the FERES doctrine: (Thanks to Jeff Trueman for the extract of FERES in his book titled “Beyond the Scope of Justice). “FERES doctrine was born in December 1947, when 1st Lt Randolph Feres died in a fire in an Army barracks at Pine Camp, NY. Believing that the fire was caused by a defective heating plant, his widow sued the U.S. Three years later, in 1950, the Supreme Court dismissed her suit. Explaining the majority opinion, Justice Robert Jackson said that members of the armed services may not sue the government for death or injury resulting from activities "incident to service". As a result of this case, this has set precedent that medical malpractice, experimentation, accidental injury, anything that the government (to include Federal Employees) does to its men and women in uniform, can be done with no accountability to those that did the deed, as well as no justice for the member, and/or their family.

More than 1,200 who had anthrax vaccine now sick

2005-06-18T07:12:00.000-07:00

More than 1,200 who had anthrax vaccine now sick
By Jeff Donaldson
LAS VEGAS SUN

More than 1,200 military personnel who received the anthrax vaccine before
going to Iraq have developed serious illnesses, according to an Army report
released last month, though local military officials contend the shots still
are safe and necessary.

Since 1991 and the first Gulf War, the Defense Department has required
service members to be immunized against such childhood diseases as Typhoid
and Hepatitis A as well as against biological agents such as anthrax, when
deploying to Korea or the Middle East.

But with Army officials reporting 1,200 illnesses and several thousand more
queries about potential side effects, the Defense Department has started
allowing troops deploying overseas to opt out of receiving the anthrax
vaccine without penalty, according to the Army and Air Force.

Maj. Brian Blalock, public health flight commander at Nellis Air Force Base,
said the anthrax shot is no longer mandatory for service members who are
willing to sign a waiver releasing the military from liability. Still, the
majority of service members elect to have the shot, he said.

"We've really not seen a big problem with anthrax -- nothing outside of the
normal range of side effects," Blalock said.

Roughly 30 percent of men, and 60 percent of women, who receive the anthrax
vaccine have some sort of minor reaction, such as swelling or a small lump
at the injection spot, Blalock said.

But the illnesses reported by the Army have been more severe. Initial
symptoms of the reported cases included minor diarrhea, cramping and fever
to more intense problems like sleep and memory loss, chronic fatigue,
headaches and chest pains.

Local numbers for service members affected are not available.

The national cases have been handled by the Vaccine Healthcare Centers,
which are located at several U.S. military bases, but are overseen by the
vaccination program at Walter Reed Army Medical Center in Washington D.C.

Despite the illnesses, Walter Reed officials contend that more than 1.3
million military and civilian personnel have received the vaccine since 1998
when the military began requiring members to receive a series of six shots
to guard them against the anthrax virus.

The hospital contends anthrax vaccinations are safe and more necessary than
ever, especially considering the threat of anthrax contamination that hit
several post offices and office buildings following Sept. 11.

"We're living in a completely different era. There are terrorists who are
intent on using biological agents and there are countries that certainly
have the capability," Blalock said.

The military shut down the anthrax vaccination program temporarily prior to
1998 citing concerns about outdated versions of the shot. The necessity of
the shot has been a hot point of debate in Washington and among soldiers'
advocacy groups that contend illnesses from the vaccine have put some
members out of the service.

Medical officials hope that educating service members about the benefits of
getting the shots will encourage "across the board" compliance. They contend
there is insufficient information to quantify the seriousness of illnesses
resulting from the anthrax vaccine.

The Nevada National Guard, which routinely deploys members to Iraq and
Afghanistan to fight the global war on terror, still requires the anthrax
shot for soldiers and airmen going there or to Korea.

Spokeswoman Lt. April Conway said there have been no reported cases of
adverse reactions to the shots among Guard members, but there have been some
members who refused to have the vaccine.

"A couple years ago we had a few people who asked not to do it," Conway
said. "Their positions were filled by volunteers who were willing."

Though military budget concerns may force the closure of the Vaccine
Healthcare Centers which oversees assessment and treatment of anthrax-based
problems, Congress and the Food and Drug Administration have approved an
emergency use authorization to fund more of the anthrax vaccine.

Citing a renewed threat of anthrax poisoning to U.S. forces overseas, the
Pentagon announced last month it would resume providing mass anthrax
vaccinations for service members deploying to Korea or Southwest Asia.

While the debate about the seriousness of anthrax-related illnesses is
likely to get bogged down in the same discussion over such war-related
illnesses as Gulf War Syndrome, Blalock is among those who believe the
benefits far outweigh the cost.

"There are a lot of diseases out there -- very lethal, very deadly," Blalock
said. "It really comes down to people making the best choice."

DU VS multiple shots

2005-06-10T05:48:00.000-07:00

The Outpost says it has been unable to find sources concerning depleted uranium and Gulf War Syndrome [Letters, May 26]. While that is not my area of focus, I do know that Kansas State University, among others, conducted a remarkable survey of Gulf War veterans, and has documented the results in a report which can be found here: http://www.geocities.com/kansasvet/pgwstudy.htm
There seems to be no one cause for Gulf War Syndrome, but it has been determined that the anthrax vaccine, an experimental drug, has definitely played a role. Most likely PB pills, another experimental drug given to ward off exposure to nerve gas, played a role as well. In addition, the military tends to give multiple vaccines at once, something that not all immune systems can handle.

In Gulf War I, service members were also exposed to nerve gas in certain areas, and the smoke from the oil fires didn’t help. Depleted uranium has been written about on the Internet in connect with certain cancers, with at least one report stating the military incidence of such cancers was particularly high in Bosnia.

I hope this helps those wanting further information. I run a web site called the Military Vaccine Resource Directory at http://www.mvrd.org.

Kathy Hubbell

Missoula

U.S. Armed Services Outline Implementation of Voluntary Anthrax

2005-06-10T05:45:00.000-07:00

By David Francis
Global Security Newswire

WASHINGTON - The attorney representing six anonymous Defense Department
employees in a suit that stopped a U.S. Defense Department's mandatory
anthrax vaccination program is praising implementation plans outlined
by the
Armed Services last month for a voluntary inoculation program (see GSN,
May
23).

However, John Michels, counsel for the Pentagon employees who requested
and
received an injunction against the mandatory program last October,
questioned why the guidance does not require soldiers to give consent
to
receive the actual vaccination. Instead, under the new practice,
vaccine
candidates are asked to acknowledge that they have received a brochure
outlining the risks associated with the vaccine.

"They don't actually have the guys signing for consent," Michels said.
"They
have to sign, 'Yes, I've gotten the brochure,' but they don't give
consent
to be vaccinated. I don't understand why."

"Why not say I certified that I received the brochure and I consent to
be
vaccinated?" Michels asked.

Calls to the Pentagon for clarification on consent were referred to the
individual branches of the Armed Services. Calls to the branches were
not
returned at press time.

Despite his confusion over consent, Michels is pleased with the
implementation plans. He said many of the requirements for
vaccinations,
allowed under emergency use authority granted to the Pentagon by the
Food
and Drug Administration, mirror what he has been asking the Pentagon
for
since the original suit was filed.

"This looks an awful lot like what we asked for," Michels said. "We're
surprised they're going through all this trouble." Michels believes
the
Pentagon is taking special care to ensure no legal challenges to the
emergency use authority.

The EUA, which allows for voluntary inoculations, took effect at the
beginning of May and expires at the end of June. It can be extended by
the
Food and Drug Administration. Throughout May, military branches gave
instructions to commanders on how to implement the voluntary program.

The Pentagon has appealed the original ruling that stopped the program
in
hopes of resuming mandatory vaccinations.

Program Implementation

The requirements outlined in actions plans for the Army, Navy, Air
Force and
Marines are generally similar. Vaccinations are limited to troops
deployed
in Central Command theaters, such as Iraq and Afghanistan, and in
Korea.
Soldiers must be informed that a federal court stopped the mandatory
program
and that all vaccinations are voluntary, and superior officers cannot
pressure anyone to take the vaccine.

All wishing to receive the vaccine must be briefed on the risks and
benefits
of the vaccines by their commanders, and must acknowledge receipt of
the
brochure explaining these risks. The Air Force requires a soldier sign
the
brochure, while the Army, Marines and Navy only require a roster be
kept of
who received the information.

All data on immunization will be entered into the soldier's medical
file and
tracked electronically using the system of each respective branch.
Refusals
will also be tracked. Reports of adverse events associated with the
vaccine will be tracked in the Vaccine Adverse Events Reporting System.

If a soldier is transferred outside of Central Command or Korea, the
regimen
of vaccination shots does not have to continue.

The Coast Guard's plan is much more limited, only allowing vaccinations
of
personnel in specific areas determined by the Pentagon.

Vaccinations cannot begin until the Military Vaccine Agency certifies
that
the brochures explaining risks are received by the individual branches.

Michels said these requirements ensure soldiers are well-informed
before
taking the vaccine, and know they have the option to refuse.

"This is starting to look more and more like the practice of medicine,"
he
said.

Military Vaccines Trigger Special Treatment for 1,200

2005-05-06T18:49:00.000-07:00

By David Ruppe
Global Security Newswire

WASHINGTON - Approximately 1,200 U.S. military personnel who received
vaccinations against biological agents during the past two years
developed
complex, in some cases debilitating, illnesses that were assessed or
treated
by a specialized network of clinics, according to figures released to
Global
Security Newswire by the U.S. Army and a review of some cases (see GSN,
April 25).

The cases, corresponding with a massive Defense Department effort to
vaccinate U.S. forces against anthrax and smallpox before and after the
invasion of Iraq, included muscle and joint weakness and pain, chronic
fatigue, intense migraines, cognitive problems, and severe diseases
such as
multiple sclerosis. Some of these have ended military careers.

More common and less serious side effects from the vaccines are said to
include temporary headaches, fatigue, fever, nausea and dizziness.

In light of the large number people who received the vaccines, the
number of
serious cases treated by the Vaccine Health Care Centers, a network of
four
clinics at domestic U.S. military bases, is rare. Overall, the military
says
more than 1.3 million military and civilian personnel have received the
anthrax vaccine, called Anthrax Vaccine Adsorbed, since 1998, when it
resumed the vaccinations after a hiatus over quality control problems.
The
military has also vaccinated hundreds of thousands of personnel, many
who
also received the anthrax treatment, for smallpox beginning in December
2002.

The Defense Department, on a Web site that provides information on the
vaccine, maintains the anthrax vaccinations are "as safe as other
vaccines"
and necessary.

None of the personnel treated in fiscal 2004 "has suffered loss of
life,
limb or eyesight," according to a statement from Walter Reed Army
Medical
Center, which houses the main Vaccine Healthcare Center in Washington.

Nevertheless, some cases have been quite severe, such as that of
retired Air
Force Reserve Lt. Col. Michael Gylock, who within nine days after
receiving
anthrax and smallpox vaccinations in March 2003 started showing
symptoms and
was eventually diagnosed with multiple sclerosis and some vision loss.

"I've been retired because of it. I'm not fit for military duty," he
said.
Gylock and other cases were referred to Global Security Newswire by an
advocate of soldiers who believe they were harmed by the vaccine.

Questions have surfaced in recent years about the safety of the anthrax
vaccine, and when massive numbers of personnel are vaccinated, even a
small
percentage of rare disorders can add up.

Walter Reed said that about 600 anthrax vaccine recipients in fiscal
2003
and 600 in fiscal 2004 received in-depth assessment or treatment by the
centers' staff. In addition, officials have said the Vaccine Healthcare
Centers during the two years conducted more than 250,000 telephone,
e-mail
or face-to-face communications with personnel or physicians to discuss
reactions, however minor or major, or to provide guidance on how to
avoid or
treat complications.

Sufficient funding for the four Vaccine Healthcare Centers, created by
Congress in 2001 is in question this year. The centers were not
included
last year in the Pentagon's fiscal 2005 budget and did not receive a
specific congressional appropriation. A nonbinding resolution passed by
the
Senate urging full funding was stripped from a supplemental
appropriations
bill this week by leaders from both houses.

Meanwhile, the Pentagon, citing a determination that there is potential
for
a heightened risk of an anthrax threat to U.S. forces, announced
Tuesday it
would resume providing mass anthrax vaccinations to service members
mainly
in South Korea and across the Middle East and South Asia (see related
GSN
story, today).

"Without the centers [there are] over 1,000 military personnel who
would not
have gotten the care they deserve, the best possible care we can
provide,"
Senator Joseph Biden (D-Del.), who had proposed specific funding for
the
centers, said in a Senate floor speech last month.

"If the department believes it is an emergency to resume that vaccine,
how
can we consider preserving the Vaccine Health Care Centers any less?"
he
said.

Quantity of Serious Illnesses Uncertain

While the data on Vaccine Healthcare Center treatments give some
indication
of the numbers and types of rare illnesses that may result from anthrax
or
smallpox vaccinations, there is no definitive data on how many and
which
illnesses were caused by the military inoculations.

One reason is that the numbers of cases treated by the centers, and
otherwise identified through its Vaccine Adverse Event Reporting
System, do
not necessarily account for all serious illnesses caused by a vaccine
because military reporting on side effects is passive. In other words,
the
onus is on the soldiers to seek help from the centers and many are said
to
be unaware the clinics exist, are unwilling to inform superiors they
may
have a career-jeopardizing disorder, or have had trouble convincing
authorities of the illness.

As little is understood about how vaccines cause serious illness, some
doctors have appeared reluctant to conclude a vaccination may have
caused a
specific illness, experts have said.

"Because serious problems are rare, it is difficult for the average
base
physician to develop the expertise needed to provide the best
treatment,"
Biden said in his speech.

In addition, as multiple military vaccines are often given around the
same
time, researchers have difficulty determining which one might have been
the
cause of a particular illness, experts have said (see GSN, May 18,
2004).

Furthermore, just because a person had experienced adverse events after
those vaccinations, does not necessarily mean the events were caused by
the
vaccinations, Walter Reed said in a statement.

"Cause-and-effect evaluations require consideration of at least six
factors;
timing is only one of those factors. Cause-and-effect evaluations are
often
difficult in individual cases," it said.

Little Understanding of Causality

Air National Guard Technical Sgt. Rick Brown's case is illustrative of
the
challenge to understanding causality. A Philadelphia firefighter and
formerly an avid bodybuilder and hockey player, Brown said that soon
after
receiving anthrax and smallpox vaccinations in March 2003 he
experienced
intense pain in muscles and joints and decreased mobility.

"My first indication was a mass on the side of my neck that was about
the
size of a grape and immediately my body started feeling really bad. I
had
open mucus membranes throughout my body, oozing out of my ears, my
nose, my
penis, my mouth," he said.

Brown said he was eventually diagnosed with degenerative arthritis,
including joint and muscle aches, and may have had a heart attack. He
was
also twice ruled unfit for military work after 19 years of service.

"For a while, my muscles turned to jelly, my joints were just all
screwed
up," he said.

Brown said he learned of the Vaccine Healthcare Centers from an
Internet
search. Military physicians were initially unwilling to send him to a
center
and unwilling to consider that the anthrax vaccination might be causing
his
illnesses, he said.

"They said, 'We want to send you to a clinical physiatrist. We want to
heavily medicate you,'" he said.

In a case review delivered to Brown, the Vaccine Healthcare Center at
Walter
Reed said it had identified possible side effects from the anthrax
vaccine.
It noted, though, causality between the vaccination and such chronic
illness
has not been proven. The center and another organization are preparing
to
study that question.

"At the present time, it is impossible to prove or disprove a causal
link
between the vaccine and chronic problems but efforts are under way . to
collect information regarding these problems and continue to define the
range of the problem," the center said generically in its review of
Brown's
case.

Brown, who served for a year in Afghanistan until November 2002, "loves
the
military" and wishes he could resume service, said he might be forced
out
before he is eligible for retirement, which is in about six months.
"Let's
put this stuff on the shelf, because a lot of people are getting sick,"
he
said.

Gylock said an informal Air Force medical board had recommended
discharging
him without benefits because the illness was not caused by military
action.
An appeal to a formal board reversed the decision. That board cited a
Vaccine Healthcare Center conclusion that his symptoms may have been
caused
by the anthrax vaccine, he said.

The center, also said, though there is a medical community controversy
over
whether vaccines can cause multiple sclerosis and that, that "causality
cannot be established."

The Vaccine Healthcare Center's "review of my records was probably the
most
beneficial thing that happened to me," he said.

Judge Demands Update On Anthrax Vaccinations

2005-04-23T05:54:00.000-07:00

April 22, 2005
By THOMAS D. WILLIAMS, Courant Staff Writer

U.S. District Court Judge Emmet G. Sullivan asked Pentagon officials in Washington, D.C., Thursday why they should not be held in contempt for violating court orders to keep him apprised of anthrax vaccinations in the military.

On April 1, Sullivan ordered the U.S. Department of Defense to file weekly reports regarding inoculations of service members in violation of his Oct. 27 injunction halting mandatory use of the vaccine. The judge set a Monday noon deadline for the department's answer. The department had told Sullivan the violations were inadvertent.

In the injunction, Sullivan said the law requires that service members be told about the unlicensed drug's possible side effects and that they must consent to be vaccinated. Without consent, the military would need a presidential waiver to force use of the drug.

Weeks after his order, Sullivan asked the Pentagon for reports on any illegal vaccinations. Pentagon officials first acknowledged that approximately 700 service members were illegally inoculated. Later, officials revealed some inoculations had been given as recently as March 7, when nine U.S. Marine reservists were vaccinated in Cincinnati. The Pentagon reportedly sent out letters weeks ago to advise those vaccinated that the court had prohibited the practice.

In April, Sullivan reconfirmed his order after the Pentagon filed legal motions asking for a change in it. He said the Department of Defense must notify all military personnel facing inoculation with the anthrax vaccine that they will not be punished if they refuse to take it. But he agreed to leave untouched an emergency authorization from the U.S. Department of Health and Human Services allowing voluntary inoculations.

A total of 1.25 million of the 2.4 million service members have been vaccinated since the program began in 1998. It protects against airborne anthrax spores, requires six shots and annual boosters.

The adverse reaction rate of the vaccine is 100 times higher than the figure initially stated by the vaccine's manufacturer. Adverse reactions include immune disorders, muscle and joint pain, headaches, rashes, fatigue, nausea, diarrhea, chills and fever.

Pentagon clear to give anthrax shots again

2005-04-04T07:10:00.000-07:00

By Dee Ann Divis
Senior Science & Technology Editor

WASHINGTON, DC, Apr. 1 (UPI) -- The Department of Defense effectively was
cleared Friday to resume vaccinating military service members with the
controversial anthrax vaccine, but it also was placed under court order to
submit weekly reports to assure the vaccinations would remain voluntary.

The inoculation program was suspended last Oct. 27 after U.S. District Court
Judge Emmet Sullivan ruled the compound -- called Anthrax Vaccine Absorbed
or AVA -- had not been properly approved for use against inhalation anthrax.
It was illegal, the judge said, to administer it to service personnel until
the Food and Drug Administration properly approved the drug. As a result he
issued an injunction against the program.

When the injunction took effect, the only way AVA could be used prior to FDA
approval was either with a presidential waiver or with the informed consent
of those who agreed to the vaccination. The original program was mandatory
and those who refused vaccination often were disciplined -- even
court-martialed.

At the Friday hearing, however, Sullivan agreed to a Pentagon request to
modify his injunction to allow vaccinations under a special emergency waiver
called an Emergency Use Authorization.

The EUA was issued in January 2005 by the Department of Health and Human
Services and the FDA under new authority granted by the Bioshield Act.
Bioshield, the same bill that allocated over $5.5 billion for the purchase
of new vaccines, was signed into law last year.

The modification will allow the military to proceed with its inoculations as
long as it gives each serviceman or woman a brochure about the vaccine and
makes sure they are aware they can forego vaccination without fear of
penalty. That last point was very important to Sullivan, who said the change
he was making to the injunction would not take effect until Monday, so it
would give the Pentagon time to lay out a plan for making clear to military
personnel they could refuse vaccination for anthrax.

"This is a weighty decision people have to make," Sullivan said. "I want
them to know they have choices."

Effectively ignored in the debate, however, was the amount of information
that would be provided to those facing inoculation. Under the original
informed-consent approach, each person would have received a full statement
of the vaccine's risks.

The brochure submitted to the court falls far short of that, critics said.
While limiting the information slashes the amount of paper work -- a
practical consideration in the face of vaccinating potentially thousands of
enlisted, reserve and contract personnel -- it also means the Pentagon will
not have to describe problems with the vaccine in detail.

The greatest concern has been the voluntary nature of the shots, not the
question of informed consent, said Mark Zaid, an attorney representing
opponents to the vaccine.

"Congress allowed the (Defense Department) to exempt informed consent in
this statute," Zaid told United Press International. "I am not sure there is
anything we can do about that."

Congress will review the issue again, said Lawrence Halloran, staff director
and counsel for the House Government Reform Subcommittee on National
Security.

"I suspect," Halloran told UPI, "we are talking about a hearing before
anything else where we get HHS and FDA and DOD in here and say 'What were
you thinking?'"

Sullivan made it clear whatever use was made of the EUA, the injunction
remained in place. He ordered the Pentagon to submit weekly reports on any
vaccinations given outside the permission granted by the EUA.

The reports will show zero violations, assured attorney Andrew Tannebaum,
who spoke on behalf of the Pentagon.

"If the answer is anything other than zero, the court will consider high
monetary fines," Sullivan said. "I'm talking high five figures or six
figures."

Forced Vaccines Haunt Gulf Vets

2005-04-01T05:26:00.000-08:00

By. Elliot Boren

It was, the doctor at the Long Beach Veteran's Administration Hospital said, an incidental finding. A little gray smudge on the X-ray, a blob next to the pituitary gland.

Six months later, University of California at Los Angeles surgeons worked six hours to sever a tumor from the brain of a muscular, 25-year-old ex-Special Forces Ranger and Gulf War veteran. The costly surgery was performed at UCLA, the patient said, because VA doctors denied that the "incidental finding" caused his excruciating, unremitting headaches.

He blamed Army-administered drugs for the tumor. And his girlfriend said there were other "side effects" of his service in the Gulf, including increased agitation and sperm that "burned."

"We had a third day of shots before we went over (to the Gulf)," said the ex-Ranger, who requested anonymity because his Army Reserve commitment has yet to expire. "Guys in other units only had two, but most Rangers had three. They wouldn't tell us what they were for."

Are this young man and tens of thousands of other veterans suffering from Gulf War sickness victims of coincidences beyond the Pentagon's control? Or are they casualties of a government that trampled both the Nuremberg Code and its own policies against forced medical experimentation?

Ruling in the 1947 trial of 23 Nazi doctors and medical administrators charged with crimes against humanity during World War II, judges of the American Tribunal in Nuremberg set forth 10 conditions for permissible medical experiments.

In a February 1953 directive, Defense Secretary Charles Wilson established what is still the "law of the land" governing such experimentation. Consistent with the Nuremberg Code, the directive's cornerstone is voluntary consent.

"The voluntary consent of the human subject is absolutely essential," Wilson wrote, ordering that such consent be given in writing before at least one witness. Wilson also banned use of "force, fraud, deceit, duress, over-reaching or other ulterior form of constraint or coercion" in obtaining consent.

Did the Pentagon obey this directive during the Gulf War?

According to Dr. Jane M. Orient, executive director of the Association of American Physicians and Surgeons, it did not.

The administration of experimental drugs without consent was, Orient said, "the first instance in which an official government agency officially sanctioned the direct violation of the Nuremberg Code."

Story continued on Page 2 »

Fort Bragg Officer's Hiccups, Death A Mystery

2005-03-28T05:39:00.000-08:00

FAYETTEVILLE, N.C. -- The family of a Fort Bragg officer recently back from Iraq said Capt. Terrance Wright seemed to hiccup almost constantly for weeks before he died earlier this month.

The Army said Wright died of an unknown illness shortly after returning from Iraq in February. His body was found in a Fayetteville motel room on March 2.

Wright's mother, Sandra Wright, and an aunt, Karen Wright, said Wright had been a healthy 33-year-old before he deployed to Iraq in November. It was his second tour in Iraq.

Karen Wright said she spoke to her nephew in Iraq in early February.

"He could not speak one sentence without hiccuping," she said.

Wright was seen by doctors in Germany and at Walter Reed Medical Center in Washington, D.C., before being sent to a doctor at Womack Army Medical Center on Fort Bragg last month, said Capt. Kevin Broadnax, an Army casualty assistance officer.

Federal privacy laws bar the Army from saying why Wright was being seen at Womack, hospital spokeswoman Shannon Lynch said.

An autopsy performed on Wright's body by Womack doctors was inconclusive, Lynch said. The hospital is waiting for the results of toxicology tests, she said.

Karen Wright said she talked to her nephew again on Feb. 17 while he was at Walter Reed. Again, he "hiccuped constantly" but didn't complain about anything, she said.

She said she next spoke to her nephew Feb. 19, when he called from Fayetteville to say he would catch a train the next day to his native Charleston, S.C.

Capt. Wright spent three days in Charleston, his mother said. He hiccuped the entire time and looked "weak in the eyes," Karen Wright said.

The officer returned to Fayetteville and checked into a motel on Feb. 24. A motel clerk said she knew Wright because he had stayed there before. She said he looked tired when she saw him last.

Karen Wright said the last time anybody reported seeing her nephew was Feb. 25, five days before his body was found.

On that day, according to Sandra Wright, a captain in his battalion said she asked her son if he was feeling all right. Capt. Wright had been sweating profusely, Sandra Wright said she was told.

Karen and Sandra Wright described Capt. Wright as a quiet, soft-spoken man who rarely complained.

"We are waiting for answers," Sandra Wright added. "We want to be able to know what happened to him."

Karen Wright said a bottle of lisinopril, a medication to lower blood pressure, was found in Capt. Wright's belongings in the motel room. The bottle indicated that the prescription was filled on Feb. 1. All 30 pills remained inside, Karen Wright said.

Capt. Wright's death follows the deaths of two North Carolina soldiers who died after returning from the Middle East and experiencing flu-like symptoms.

State epidemiologist Jeffrey Engel said the deaths of Special Forces Capt. Gilbert A. Munoz and Army Staff Sgt. Christopher L. Rogers, a reservist, were related only in their timing.

Munoz, 29, appears to have had a bacterial infection and the flu, Engel said. He died of pneumonia Feb. 9. Rogers, 37, died on Feb. 14, just two days after he began feeling ill, his wife said.

Story In rense.com

2005-03-21T12:37:00.000-08:00

11,000 US Soldiers Now
Dead From DU Poisoning
Heads roll at Veterans Administration
Mushrooming depleted uranium (DU) scandal blamed
By Bob Nichols
Project Censored Award Winner - SF Bay View
Global Research.ca
2-28-5

Considering the tons of depleted uranium used by the U.S., the Iraq war can truly be called a nuclear war.

Preventive Psychiatry E-Newsletter charged Monday that the reason Veterans Affairs Secretary Anthony Principi stepped down earlier this month was the growing scandal surrounding the use of uranium munitions in the Iraq War.

Writing in Preventive Psychiatry E-Newsletter No. 169, Arthur N. Bernklau, executive director of Veterans for Constitutional Law in New York, stated, "The real reason for Mr. Principi's departure was really never given, however a special report published by eminent scientist Leuren Moret naming depleted uranium as the definitive cause of the 'Gulf War Syndrome' has fed a growing scandal about the continued use of uranium munitions by the US Military."

Bernklau continued, "This malady (from uranium munitions), that thousands of our military have suffered and died from, has finally been identified as the cause of this sickness, eliminating the guessing. The terrible truth is now being revealed."

He added, "Out of the 580,400 soldiers who served in GW1 (the first Gulf War), of them, 11,000 are now dead! By the year 2000, there were 325,000 on Permanent Medical Disability. This astounding number of 'Disabled Vets' means that a decade later, 56% of those soldiers who served have some form of permanent medical problems!" The disability rate for the wars of the last century was 5 percent; it was higher, 10 percent, in Viet Nam.

"The VA Secretary (Principi) was aware of this fact as far back as 2000," wrote Bernklau. "He, and the Bush administra11,ooo US soldiers dead from DU.ems tion have been hiding these facts, but now, thanks to Moret's report, (it) ... is far too big to hide or to cover up!"

"Terry Jamison, Public Affairs Specialist, Office of the Deputy Assistant Secretary for Public Affairs, Department of Veterans Affairs, at the VA Central Office, recently reported that 'Gulf Era Veterans' now on medical disability, since 1991, number 518,739 Veterans," said Berklau.

"The long-term effects have revealed that DU (uranium oxide) is a virtual death sentence," stated Berklau. "Marion Fulk, a nuclear physical chemist, who retired from the Lawrence Livermore Nuclear Weapons Lab, and was also involved with the Manhattan Project, interprets the new and rapid malignancies in the soldiers (from the 2003 Iraq War) as 'spectacular -- and a matter of concern!'"

When asked if the main purpose of using DU was for "destroying things and killing people," Fulk was more specific: "I would say it is the perfect weapon for killing lots of people!"

Principi could not be reached for comment prior to deadline.

References

1. Depleted uranium: Dirty bombs, dirty missiles, dirty bullets: A death sentence here and abroad" by Leuren Moret, http://www.sfbayview.com/081804/Depleteduranium081804.shtml.

2. Veterans for Constitutional Law, 112 Jefferson Ave., Port Jefferson NY 11777, Arthur N. Bernklau, executive director, (516) 474-4261, fax 516-474-1968.

3. Preventive Psychiatry E-Newsletter. Email Gary Kohls, gkohls@cpinternet.com, with Subscribe" in the subject line.

globalresearch.ca/articles/NIC502A.html
http://www.sfbayview.com/012605/headsroll012605.shtml

Latest News on injuction

2005-03-21T12:26:00.000-08:00

Transcribing while on phone, so, this will be brief. The hearing today
lasted 2 hours 15 minutes. Judge Sullivan had some great lines that
should
show up in media reports. He expressed great
frustration at DoD's violation of his initial injunction. He stated
that
the proposed DoD letter apologizing to the troops for violating the
injunction was unacceptable to be signed by a Col, and that he wanted
it
signed by Secretary Rumsfeld. (that is for the contempt).

On the EUA, he said that he would probably amend his injunction, but,
refuse
to endorse the DoD's use of the vaccine. He said his injunction had no
barring on a voluntary program, and that if DoD chose to start a
voluntary
program under an EUA, that the courts would entertain challenges to the
EUA
at that time. He made no decision in the hearing itself and said that
he
would rule on or before April 1st. He scheduled a hearing for 10:00 am
on
April 1st, which may or may not occur, depending on whether Sullivan
reaches
a decision on both the contempt and the EUA decisions sooner. Media
articles will be forthcoming in the next 24 hours or so. Bottom line
we get
extra hearings..
Very many thanks, appreciation and forever gratitude to those that
attended
today, those that have been working behind the scenes, and the
attorneys
that are still challenging to ensure laws are complied with as it
relates to
investigational drugs and the EUA on behalf of our service members, DoD
contractors, and eventually, the public.

Judge warns Rumsfeld in anthrax case

2005-02-17T05:26:00.000-08:00

Washington, DC, Feb. 15 (UPI) -- A judge in Washington has warned Defense
Secretary Donald Rumsfeld he could face contempt for ignoring a ruling on
Pentagon anthrax vaccinations.
In October, U.S. District Judge Emmet Sullivan largely struck down the U.S.
military's involuntary vaccinations for weaponized anthrax.

The judge said the program could not be administered unless individual
service members give "informed consent" to the vaccinations, President Bush
issues a specific waiver or the Food And Drug Administration properly
classifies a drug for use in the program.

A 1999 executive order by then President Bill Clinton required "informed
consent" before administering the vaccine.

Monday, Sullivan ordered "Donald H. Rumsfeld" to "show cause by Feb. 28" why
"he/or the government should not be held in contempt" for failing to follow
the earlier ruling.

Sullivan also ordered Pentagon employees and soldiers challenging the
program to respond to an emergency motion by the Pentagon asking that the
earlier injunction.
full story

What Bioshield II is Really About: Cynically Playing on

2005-02-17T05:23:00.000-08:00

WASHINGTON, Feb. 8 /PRNewswire/ -- The Generic Pharmaceutical
> Association (GPhA) today issued a strong warning to the Senate that
> biodefense legislation (S. 3) in its current form would effectively
> extend patents for marketed drugs and delay access to more affordable
> generic medicines-unnecessarily increasing prescription drug costs to
> consumers, businesses, and government purchasers by tens of billions of
> dollars a year.
>
> "The legislation in its current form would provide enormous profits to
> brand companies by keeping affordable generic medicines off the market,
> leaving consumers and private and public purchasers to foot the
> multi-billion dollar bill," said GPhA President and CEO Kathleen
> Jaeger. "It is outrageous that under the guise of homeland security,
> the brand pharmaceutical industry is seeking patent extensions for
> everyday medicines at the expense of consumers, especially seniors and
> the uninsured-individuals who need affordable, life-saving generic
> medicines the most."
>
> S. 3 is intended to strengthen America's preparedness to bioterrorism
> through measures that accelerate the research, development and
> manufacture of novel countermeasure agents. It contains promising
> incentives, such as needed product liability protections, expanded tax
> incentives, and fast track FDA review of drug applications, which GPhA
> supports. However, it also includes provisions that would provide
> substantial and unnecessary windfalls to the brand pharmaceutical
> industry, impose a tremendous, and needless burden on the nation's
> health care system, and offer little enhancement to overall national
> security.
>
> Specifically, GPhA opposes provisions in the legislation that:
>
> -- Define a countermeasure so broadly that almost every drug in most
> people's medicine cabinets would qualify. Commonly prescribed drugs
> that
> treat headaches, nausea, and depression would be eligible for patent
> extensions with minimal testing performed by the brand manufacturer.
> Patent extensions on these products would put the healthcare system in
> crisis by adding tens of billions of dollars in expenditures on these
> already profitable drugs.
>
> -- Would allow for a "wild card" patent extension when a company has
> a countermeasure product approved (even for a secondary use to treat a
> common ailment like headaches). This "wild card" in effect transfers
> the awarded patent extension to any other product the company
> manufactures. For example, if Pfizer were to have a countermeasure
> labeling statement approved for an already existing product, it could
> reap up to two extra years of patent monopoly for a different
> blockbuster drug such as Viagra. The company also could license a
> product for which another drug company performed all the requisite
> research and development, yet still receive another wild card. The
> wild
> card could be applied at any time before patent expiration, creating
> uncertainty for generic companies to invest in the requisite
> development
> of affordable medicines.
>
> -- Allow for unlimited patent extensions per product. Under current
> law, only one patent can be extended for developing a novel drug
> product. Under S. 3, multiple patents claiming the brand drug can be
> extended, forcing consumers to pay monopoly prices for many years to
> come and keeping generics off the market.
>
> -- Would extend the patent terms of products that qualify as
> countermeasures up to the full amount of time from when the patent is
> issued until the product is approved. Current law balances innovation
> and access by providing only 5 years of the regulatory review period to
> be added to the patent's life. If a company were given the full review
> time under an unlimited regulatory review period, it could add a decade
> of patent exclusivity and monopoly pricing per brand product. Moreover,
> providing patent extension for the full development time is contrary to
> the intent of the goal of expediting research and development.
>
> -- Enable brand companies to be rewarded for the simple testing for
> new indications of currently marketed drugs, even if the federal
> government already has determined which everyday medicines are
> effective
> countermeasures for known bioterror threats. For instance, the Centers
> for Disease Control, the National Institutes of Health and Department
> of
> Defense provide a wealth of information on currently available products
> to use in case of exposure to many forms of biological and chemical
> agents. Since the research already has been performed at taxpayers'
> expense, there is no reason the brand pharmaceutical company that
> manufactures the product should be given any additional market
> protection on that product or any other product.
>
> "As drafted, S. 3 threatens the economic viability of the nation's
> health care system by penalizing new generic drug development, offering
> wild card exclusivity, and unnecessarily extending current patent
> terms.
> These proposals have been previously rejected by Congress as catering
> to
> special interests at the public's expense," said Jaeger. "These
> provisions will pose major economic challenges to already overburdened
> employers, insurers, consumers, and government programs such as
> Medicare
> and Medicaid. Given the growth in the number of uninsured Americans,
> serious deficits in Medicare and Medicaid programs, soaring health
> insurance premiums, and the numerous other crises facing the health
> care
> system, the financial and health care impact of S. 3 would be
> disastrous.
>
> "GPhA is looking forward to working with Congress to remove these
> onerous provisions from the bill and to help support the overall goal
> of
> securing America," Jaeger said. "No industry is more committed than the
> generic drug industry to protecting public safety, ensuring access to
> affordable, high-quality pharmaceuticals, and rewarding true
> innovation."
>
> GPhA represents the manufacturers and distributors of finished generic
> pharmaceuticals, manufacturers and distributors of bulk active
> pharmaceutical chemicals, and suppliers of other goods and services to
> the generic drug industry. Generics represent 51% of the total
> prescriptions dispensed in the United States, but less than 8% of all
> dollars spent on prescription drugs. The Generic Pharmaceutical
> Association is committed to improving lives for less. For further
> information, please contact GPhA at 703-647- 2480, or visit our web
> site
> at http://www.gphaonline.org.

DoD seeks to resume anthrax shots on voluntary basis

2005-02-09T19:49:00.000-08:00

Government attorneys are asking a federal judge to modify his 3½-month-old order that halted the Pentagon’s mandatory Anthrax Vaccine Immunization Program so shots can resume on a voluntary basis.
Judge Emmet Sullivan of the U.S. District Court for the District of Columbia said in an Oct. 27 ruling that the Food and Drug Administration failed to follow its own procedures when it determined a year ago that the anthrax vaccine is safe and effective for all forms of the disease, including the inhalation form, which the Pentagon says is a germ warfare threat.

Sullivan’s order said the vaccine could be used to protect against inhalation anthrax only if a service member gives informed consent — which involves specific procedures outlined in federal law — or if the president waived the right to informed consent, also allowed under federal law.

But Sullivan’s order did not address another federal law known as Project BioShield, under which the Pentagon recently received “emergency-use authority” from the FDA to resume anthrax shots for troops as long as they have the option to refuse. It was the first time any federal agency requested such authority under that law.

Because this had not previously been an issue in the ongoing court case, government lawyers want Sullivan to give his assent before the Defense Department moves forward.

“Out of an abundance of caution, defendants respectfully request that the court modify its injunction to expressly acknowledge the legality of DoD’s use of [anthrax vaccine] pursuant to the emergency-use authority,” states the 12-page motion filed by the Justice Department on behalf of the Pentagon.

“The resumption of AVIP as a voluntary program is consistent with the spirit of the court’s prohibition of [anthrax vaccine] inoculations in the absence of informed consent or a presidential waiver of the informed consent requirement.”

John J. “Lou” Michels, an attorney for six service members and civilian defense employees who sued to stop the mandatory program on the basis that the vaccine wasn’t licensed to protect against inhalation anthrax, said he expected the government to ask Sullivan’s permission to resume the program.

But he was surprised the government’s motion did not include a brochure explaining to service members that they don’t have to take the shots, which, essentially, is the consent document.

Michels said there is no indication of how government officials plan to monitor the consent issue.

“Apparently, consent is going to be manifested by taking the shot,” he said.

A hearing is scheduled for Feb. 14 in Sullivan’s court to discuss the government’s motion to resume the vaccine program on a voluntary basis.

Vaccinations Were Given Despite Judge's Order

2005-02-04T05:23:00.000-08:00

Washington Post
February 3, 2005
Pg. 4

More than 900 soldiers were given anthrax vaccinations in the past three months despite a federal judge's order in October to stop the program because the vaccine had not been properly tested and approved.
Col. Steven P. Jones, director of the military vaccine agency, informed Judge Emmet G. Sullivan yesterday that the vaccinations were given even though Defense Secretary Donald H. Rumsfeld sent out a directive in late October ordering that the vaccinations be stopped until further notice.

In a statement presented to the judge, Jones also said that after learning that some vaccinations were continuing, he sent out a message to all military medical sites around the world, telling officials to remove any anthrax vaccine that might remain in their refrigerators.

At the request of the Pentagon, the Food and Drug Administration issued an emergency authorization late last month that would allow the vaccine to be used without full agency review and approval. The department said it has no plans to immediately re-start its program.

FDA Rules On Military's Anthrax Vaccine

2005-02-02T07:46:00.000-08:00

By THOMAS D. WILLIAMS
Courant Staff Writer

February 1 2005

The Food and Drug Administration Monday issued an emergency order allowing the military to use a controversial anthrax vaccine.

The order, published in the Federal Register, came three months after a federal court stopped the Pentagon from forcing servicemen to be vaccinated or face punishment. The new order permits voluntary use.

The FDA says the Pentagon will make its own determination whether to resume the mandatory use of the vaccine after FDA finishes reconsidering the vaccine's license March 28.

The FDA opened a 90-day period for public comment on the vaccine in December after the court stopped the military's mandatory vaccination of soldiers. That allows vaccine opponents and the Pentagon to argue the pros and cons. Ultimately, the FDA, which believes the present license is legal, is expected to validate it.

On Oct. 27, U.S. District Court Judge Emmet G. Sullivan in Washington, D.C., ordered a halt to the military's mandatory use of the vaccine. He said the vaccine was being used improperly, as supposed protection against inhaled anthrax spores. The vaccine was originally developed to fight anthrax infection absorbed through the skin. Sullivan's ruling forced the Pentagon to obtain informed consent of each service member inoculated, or a presidential waiver to allow its continued use.

Sullivan said if the military wanted to use the vaccine, the FDA would need to examine whether it is effective against inhaled spores.

Pentagon spokesman Jim Turner said Monday defense department health officials had no immediate comment on the development.

John J. "Lou" Michels, a lawyer representing the service members who challenged the vaccine in federal court, said the new FDA order "is just another example of the FDA effectively rolling over for the Department of Defense with regard to this program."

Michels said he would watch developments closely because he believes the Pentagon will find a way to illegally force service members to use the vaccine through the legal powers of the U.S. Health and Human Services Department.

Nearly 500 active-duty service members have refused the vaccine and more than 100 have been court-martialed. More than 500 pilots and flight crew have retired or transferred from the Air National Guard or Reserve to avoid the vaccine.

The adverse reaction rate of the vaccine is 100 times that initially stated by the vaccine's manufacturer. Adverse reactions include immune disorders, muscle and joint pains, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least a half dozen deaths and a number of birth defects have been attributed to its use.
Copyright 2005, Hartford Courant

Emergency order issued.

2005-01-31T19:48:00.000-08:00

It has passed, the emergency ordered authorizing anthrax vaccine be initiated again. I have linked the info page here:

http://www.fda.gov/cber/vaccine/anthraxeua.htm

If you have not submitted in your comments - this is past an emergency, do so today! Go here!
http://www.milvacs.org/Press/Release.cfm?PressRoomID=6
Again, if you need any help, please let me or someone know.

Look at this evidence!

2005-01-26T05:50:00.000-08:00

The report is titled: "Is Military Research Hazardous to Veterans' Health? Lessons Spanning Half a Century," Committee on Veterans' Affairs, United States Senate, 103rd Congress, 2nd Session, S. Prt. 103-97, U.S. Government Printing Office, Washington, D.C., 8 December 1994, ISBN 0-16-046291-6.

The relevant passage is at the top of page 35, under the heading: "RECORDS OF ANTHRAX VACCINE ARE NOT SUITABLE TO EVALUATE SAFETY."

Quote:
"Although anthrax vaccine had been considered approved prior to the Persian Gulf War, it was rarely used. Therefore, its safety, particularly when given to thousands of soldiers in conjunction with other vaccines, is not well established. Anthrax vaccine should continue to be considered as a potential cause of undiagnosed illnesses in Persian Gulf military personnel because many of the support troops received anthrax vaccine, and because the DOD believes that the incidence of undiagnosed illnesses in support troops may be higher than that in combat troops."[Italics mine]

Shays urges amnesty for troops refusing anthrax vaccine

2005-01-26T05:43:00.000-08:00

If you are a service member that has be threatened with action for refusing please eamil me. I will handle all email discreetly and help you with answeres and a support system of what you can do.

(Hartford-AP, Jan. 16, 2005 1:40 PM) _ Congressman Christopher Shays says hundreds of military officials who refused to take an anthrax vaccine should be given amnesty.

The Connecticut Republican tells the Hartford Courant that he'll introduce legislation soon to correct the military records of anyone who was sanctioned for refusing the vaccine.

Since the vaccinations began six years ago, nearly 500 service members have refused the vaccine and more than 100 have been court-martialed, according to federal court documents.

Military anthrax vaccinations have been suspended since late October, when a federal judge found fault in the Food and Drug Administration's approval process.

Defense spokesman Jim Turner says service members who feel they have been wrongly punished can appeal to the Boards of Correction of Military Records.

Anthrax Vaccine License opened for 90-day public comment period: We need your help now!

2005-01-23T17:07:00.000-08:00

Newsflash
Anthrax Vaccine License opened for 90-day public comment period: We need your help now! Click on http://www.fda.gov/cber/rules/bvactox.pdf

Click here to submit your comments: http://www.regulations.gov/AGCY_FOODANDDRUGADMINISTRATION.cfm
Comments accepted until March 29, 2005:

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids
with standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel’s findings and recommendations, FDA is proposing to classify these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness). On December 13, 1985, FDA proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids. After reviewing the Panel’s report and comments on the proposal, FDA published a final rule and
final order on January 5, 2004. FDA is issuing this proposed rule and proposed order again to provide notice and to give interested persons an opportunity to comment.

Instructions: All submissions received must include the agency name and Docket No. for this proposal. All comments received will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided.

DATES: Submit written or electronic comments on the proposed rule and proposed order by [insert 90 days after date of publication in the Federal Register]. Publication date expected to be Dec. 29, 2004 - Editor's note.

ADDRESSES: You may submit comments, identified by Docket No. 1980N–0208, by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

• Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site.

• E-mail: fdadockets@oc.fda.gov. Include Docket No. in the subject line of your e-mail message.

• FAX: 301–827–6870.

• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the agency name and Docket No. for this proposal. All comments received will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any
personal information provided.

For detailed instructions on submitting comments and additional information on the process, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and
insert the docket number found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

The Military Vaccine Action Committee MVAC-PAC CALLS LATEST PUSH TO FORCE ANTHRAX VACCINE IRRESPONSIBLE

Friday, 17 December 2004

FOR IMMEDIATE RELEASE: DEC. 17, 2004

CONTACT: KATHRYN HUBBELL, PRESIDENT (406) 531-9355 or contact@mvacpac.org

MVAC-PAC CALLS LATEST PUSH TO FORCE ANTHRAX VACCINE IRRESPONSIBLE

ABUSE OF POWER BY THE DOD

MISSOULA, MT: Responding to last week’s request by Deputy Secretary of Defense Paul Wolfowitz that HHS Secretary Tommy Thompson declare a state of emergency in order to justified renewed use of the anthrax vaccine, MVAC-PAC President Kathryn Hubbell has called the latest move by the Dept. of Defense “another irresponsible abuse of power.” Federal Judge Emmett Sullivan declared the military’s anthrax vaccine immunization program illegal on Oct. 27th of this year.

The Judge’s ruling is not the only factor to consider. If there is a genuine anthrax threat , the DOD knows that soldiers can still get the anthrax vaccine. The DOD can provide troops with consent forms. That’s all that has ever been required.

In addition, more published reports indicate that vaccines are not the most effective way to treat anthrax. Antibiotics are a far more efficient, life-saving method, according to a Dec. 16 article in Forbes. And this article isn’t the first to come to such a conclusion.

Karl Rove, senior advisor to the President, described the anthrax vaccine as a “political problem” in a 2001 memo to Wolfowitz (see at http://www.milvacs.org/rovememo.pdf ). The Bush administration has clearly known for several years of the numerous problems associated with this vaccine.

Continually attempting to force the anthrax vaccine on the men and women of our armed services constitutes deliberate medical experimentation with an unproven, unsafe drug. Rather than protecting the troops, the DOD seems intent on using its strong-arm, bullying tactics to get its own way, even bending the law to attempt to achieve its objectives. These unconscionable acts of cowardice toward the troops who are already putting their lives on the line to defend the United States must stop. With proven, more effective, and less dangerous ways to protect our troops, DOD must at last take responsibility and face up to its own documented illegal conduct. It must compensate those who are ill, clear the names of those who rightly refused this illegal vaccine, and use better ways to protect our troops. Now.

For more information about the Military Vaccine Action Committee, L.L.C, go to www.mvacpac.org.

###

Military Vaccine Action Committee, L.L.C.

P.O. Box 8168 – Missoula, MT 59807

PH: (406) 531-9355 - e-mail: contact@mvacpac.org

Last Updated ( Friday, 17 December 2004 )
Read more...

MVACPAC.ORG Joins In Support Of Senator Bingaman's Letter To Rumsfeld For VHC Funding
Written by Administrator

Wednesday, 12 February 2003
The Military Vaccine Action Committee is pleased to be a signatory on this letter, and we encourage you to endorse it as well. Please contact Bruce Lesley in Senator Bingaman’s office at Bruce_Lesley@bingaman.senate.gov to sign on directly, or write to your Congressional delegation to endorse this funding. Thank you! VACPAC.ORG Forums Board Now Open.
Last Updated ( Thursday, 09 December 2004 )

Defense Department Embarks On Disinformation Campaign Concerning Anthrax Vaccination Program
Written by Administrator

Saturday, 12 April 2003

Involuntary Vaccinations Must Stop For A Minimum Of Three To Four Months In Order For The Government To Comply With Court Order

WASHINGTON, D.C. -- On October 27, 2004, the Honorable Emmet Sullivan of the U.S. District Court for the District of Columbia vacated an Order issued by the Food & Drug Administration and imposed a permanent injunction prohibiting the Department of Defense from administering the anthrax vaccine without informed consent or a presidential waiver. This second injunction followed Judge Sullivan's earlier decision of December 22, 2003, that the anthrax vaccine was investigational and unlicensed for its intended purpose to protect against inhalation exposure.

Since the imposition of a permanent injunction the Department of Defense has led a disinformation campaign to downplay the significance of the Court's decision, particularly regarding the length of time the injunction will remain in place. These efforts, which are made amidst convenient FDA silence, do a great disservice to the loyal men and women who are attempting to protect the United States of American in military and civilian positions. "DoD is trying to equate Judge Sullivan's granting a permanent injunction with his earlier decision granting a preliminary injunction, but that's simply wishful thinking," said Mark S. Zaid, Esq. of the Washington, D.C. Law Firm of Krieger & Zaid, PLLC, one of two lawyers who brought the lawsuit on behalf of the plaintiffs. "In fact, given the state of the medical and scientific evidence, it will be extremely difficult for FDA to make a proper case that the vaccine has any effectiveness against inhalation anthrax. That means the vaccine stays an investigational drug and it cannot be used by the military without informed consent or a presidential waiver," Zaid added.

Last Updated ( Thursday, 09 December 2004 )
Read more...

Feds move 3 ways to restart anthrax vaccine program

2005-01-13T16:36:00.000-08:00

AF Times
January 17, 2005

Feds move 3 ways to restart anthrax vaccine program
One strategy has FDA meeting judgeâ€™s ruling

By Deborah Funk
Times staff writer

The government is using a three-pronged approach to try to reinstate the militaryâ€™s anthrax vaccination program, which the Pentagon says is needed to protect service members who face a â€œheightenedâ€ risk of attack from the potential biological weapon.
In the latest move, the Food and Drug Administration is now seeking public comment on the information it relied upon to declare that anthrax vaccine was effective against all forms of the disease â€” something a federal judge in October said the FDA previously had failed to do.

The Dec. 29 notice published in the Federal Register gives the public 90 days to comment on the FDAâ€™s proposed rule on the safety and efficacy of the vaccine as protection against anthrax.

The FDA proposes that the vaccine be indicated to protect against all forms of anthrax, to include both the skin form of the disease and also inhalation anthrax, the type defense officials say could be used as a weapon.

The FDA acknowledged in its notice that the current vaccine is not the same one used in human tests done more than 40 years ago. That vaccine was obtained from a researcher at Fort Detrick, Md., and its manufacturing process has changed several times since then, as has the manufacturer.

Even so, the FDA said it has reviewed the vaccineâ€™s historical development and found that the Pentagon has had â€œcontinuous involvement with, and intimate knowledge of,â€ the formulation and manufacturing processes of the various versions of the vaccine over the years.

That, the FDA said, is enough to make a determination that the current vaccine is comparable to the original vaccine, a conclusion backed up by animal tests.

Chicago attorney John J. Michels Jr., who represents six anonymous service members and civilian defense employees who sued the government and shut down the Pentagonâ€™s mandatory vaccination program, took issue with the FDAâ€™s position.

Among other things, he questioned how the FDA could apply the human study results of the original vaccine to one that is now in its fourth version.

He also said the vaccine was not properly licensed in 1970 because the licensing agency at the time failed to account for the fact that the manufacturing process had changed since the human study was done. Also, the test results combined cases of skin and inhalation anthrax, even when there were too few inhalation cases to statistically prove whether the vaccine was effective against that form of the disease, Michels said.

The Defense Department also is forming two other lines of attack to try to reinstate its mandatory anthrax vaccine program.

On behalf of the Pentagon and the Department of Health and Human Services, the Justice Department is appealing the federal judgeâ€™s October decision that the anthrax vaccine was not licensed for inhalation anthrax, and therefore could not be forced on troops without their consent.

Outside the court system, Deputy Defense Secretary Paul Wolfowitz has asked the Health and Human Services secretary to allow the Pentagon to administer the vaccine under the â€œemergency use authorityâ€ of a law passed last year called Project BioShield.

The law says that, to the extent practicable, vaccines should be used under Project BioShield with the consent of those who are to be inoculated.

Defense officials have not said whether they plan to seek authority to make the anthrax vaccine mandatory for service members under their Project BioShield request.

In a written response to questions, defense officials said only that â€œspecific details on program resumption are being discussedâ€ with the Department of Health and Human Services.

Pentagon says military needs anthrax vaccine

2005-01-04T06:49:00.000-08:00

HHS' Thompson is urged to allow resumption of drug
By JOHN FILES
New York Times

WASHINGTON - The Pentagon is seeking authority to resume administering the anthrax vaccine to military personnel, contending that troops in South Korea and the Middle East are at particular risk of being exposed to the bacteria, military health officials said.

"We are concerned for the health and safety of our service members, particularly in worldwide operations involving the war on terrorism," William Winkenwerder Jr., the assistant secretary of defense for health affairs, said in a statement. "Intelligence indicates an ongoing threat of anthrax against our military forces."

Deputy Defense Secretary Paul Wolfowitz requested that military officials have access to the vaccine in a Dec. 10 letter to Tommy Thompson, the secretary of Health and Human Services.

"There is a significant potential for a military emergency involving a heightened risk to United States military forces of attack with anthrax," Wolfowitz wrote. He cited a classified intelligence assessment from last month to support his concern, adding that it was the basis for continuing to vaccinate troops serving in South Korea and the Middle East.

A spokesman for the Department of Health and Human Services said it was considering Wolfowitz's request. The department is authorized to respond to a terrorist attack or other emergency by allowing the military to use some drugs, such as the anthrax vaccine, which have not completed the Food and Drug Administration's approval process.

Anthrax vaccinations for military personnel were suspended in October, when a federal judge ordered the military to stop requiring troops to be vaccinated without their consent.

U.S. District Judge Emmet Sullivan found that in approving the vaccine, the FDA had not followed its procedures, which require it to seek public comment on the safety and effectiveness of vaccines before approving them.

In response to the ruling, Defense Secretary Donald Rumsfeld ordered a "pause" in anthrax vaccinations.

Rep. Christopher Shays, R-Conn., who is chairman of the House Subcommittee on National Security, Emerging Threats and International Relations, sent letters to Thompson and to Porter Goss, the director of Central Intelligence. Shays asked Goss to allow members of his subcommittee to review the intelligence report cited by Wolfowitz.

"It is vital that so important a public health matter be conducted deliberately and openly," Shays wrote. "The threat of biological terrorism is not uniquely military."

Federal officials consider anthrax one of the most serious biological threats.

Government Studies Rare Pneumonia Outbreak Among Iraq Troops

2004-12-23T10:28:00.000-08:00

TUESDAY, Dec. 21 (HealthDayNews) -- A rare and dangerous form of pneumonia, which struck 22 U.S. soldiers in 2003 and the early part of 2004, has prompted a government study to determine its origins.

This strain, known as acute eosinophilic pneumonia (AEP), is so rare that the entire medical literature contains only about 150 published accounts of it, according to lead study author Dr. Andrew F. Shorr, chief of the pulmonary clinic at Walter Reed Army Medical Center in Washington, D.C. And none of that literature has accounts of the disease striking in clusters, as it apparently did in Iraq.

There seems to be no explanation for the unusual cluster, which included two deaths, except for one salient fact -- all of the patients were smokers, and nearly all of them were new to the habit. But so far, that appears to be the only element that links the AEP cases.

"We are still in the problem-solving phase," said study senior author Dr. Bruno P. Petruccelli, director of epidemiology and disease surveillance at the U.S. Army Center for Health Promotion and Preventive Medicine. "We don't recognize all of the factors."

The study, which was sponsored by the U.S. Army Office of the Surgeon General, appears in the Dec. 22/29 issue of the Journal of the American Medical Association.

Between March and August 2003, severe pneumonia was reported in 19 U.S. military personnel. Ten of these servicemen were diagnosed with AEP. An additional eight patients were diagnosed with AEP through March 2004. Between March and June 2004, another four cases surfaced.There have been no new cases since June, despite heightened monitoring, government officials say.

All of the 18 who were diagnosed with AEP during the study period were smokers; 14 (78 percent) were recent converts. All but one reported having had significant exposure to fine airborne sand or dust. The average age of the patients was 22, and the oldest was 47.

Shorr was the first to identify the disease while serving briefly in Germany. During his tour, several otherwise healthy soldiers were admitted with respiratory failure. "They were basically happening all at the same time, and it was really very perplexing," he recalled.

Shorr was disturbed enough to order bronchoscopies, which revealed that these cases were not the more common community-onset pneumonia.

"The strongest message that comes out is the very, very, very significant association between smoking and AEP," Shorr said. Beyond that, he added, "our working hypothesis is that it's probably a multi-hit insult, where you have a susceptible host -- for whatever reason -- who then is sensitized to the environment in some way because of the amount of dust in the air or some other agent, or some other exposure on top of that."

The research ruled out several other explanations, which most will find comforting. "This does not seem to be an infectious, transmissible disease. It does not seem to be related to a vaccine, either smallpox or anthrax," Shorr said.

Despite the lack of answers, the information is still potentially lifesaving.

"From a military medicine point of view, it's important," said Dr. Norman Edelman, consultant for scientific affairs for the American Lung Association. "You have to know if you run into a strange kind of pneumonia that this is what it may be. Ordinarily we treat pneumonia with antibiotics, or occasionally with antivirals, but this gets treated with corticosteroids, which is quite different. Unless you suspect that, you would never give them corticosteroids."

The message to soldiers is not a new one: If you smoke, stop, and if you don't smoke, don't start. "New-onset smoking is an issue. This is a unique risk that is nearly uniformly avoidable," Shorr said. "Recent newspaper articles have reported that people are trying to collect cigarettes to send to service members for the holidays. I would counsel against that. There are many other things you can do to support our troops."

Defense seeks emergency authority to resume anthrax vaccinations

2004-12-16T07:13:00.000-08:00

The Defense Department has asked the Health and Human Services Department for emergency authority to resume its anthrax vaccination program for military personnel, Government Executive has learned.

Deputy Defense Secretary Paul Wolfowitz issued a Dec. 10 memo asking HHS Secretary Tommy Thompson to declare an emergency in order to justify using the vaccine for protection against inhaled anthrax. The military's anthrax vaccination program was suspended in late October by a federal judge in response to a lawsuit filed by six anonymous plaintiffs. The lawsuit argued that the vaccine was not proven to protect against inhaled anthrax, and led to health problems.

In the memo, Wolfowitz said he has "determined there is a significant potential for a military emergency involving a heightened risk to United States military forces of attack with anthrax."

"In making this determination," Wolfowitz added, "I have considered a classified November 2004 Intelligence Community assessment of the anthrax threat. This heightened risk has been and continues to be the basis for the DoD program of vaccinating personnel serving in the areas of the Central Command and Korea."

Central Command is responsible for operations in Iraq and Afghanistan. More than 1.2 million troops have been inoculated under the anthrax vaccination program since 1998.

A HHS spokesman was unaware of the request and had no comment. The Defense Department did not provide comment by press time.

Judge Emmet Sullivan of the U.S. District Court for the District of Columbia ruled Oct. 27 that the military must stop administering the BioThrax vaccine, also known as Anthrax Vaccine Adsorbed, to service members. The vaccine is produced by BioPort Corp. of Lansing, Mich.

The Food and Drug Administration previously issued a final rule and order in December 2003 that licensed the vaccine as safe and effective for anthrax, regardless of the route of exposure. The judge, however, vacated that final rule and order, saying FDA did not follow proper procedures to determine whether the vaccine is safe and effective against inhaled anthrax.

"Unless and until FDA properly classifies AVA as a safe and effective drug for its intended use, an injunction shall remain in effect prohibiting [the military's] use of AVA on the basis that the vaccine is either a drug unapproved for its intended use or an investigational new drug," Sullivan wrote. "Accordingly, the involuntary anthrax vaccination program, as applied to all persons, is rendered illegal absent informed consent or a presidential waiver."

The chief lawyer for the lawsuit called DoD's request for emergency authority "legally ineffective."

"This is just another attempt to betray the members of the military and circumvent the now judicially determined problems with the vaccine," said Mark Zaid, managing partner of Krieger & Zaid in Washington.

He cited a provision under Project BioShield stating that only the defense secretary has the authority to determine if there is an emergency, as opposed to the deputy defense secretary. Even then, Zaid claimed, the military must seek consent from military personnel or a presidential waiver in order to resume the vaccination program.

"Neither DoD or HHS has the authority to grant a waiver. It has to be the president," Zaid said.

"Just because they declare a military emergency doesn't allow resumption of the program. It is a step toward it but it doesn't allow resumption," he added. "This changes nothing but raises a tremendous amount of questions that Congress ... should immediately demand answers for."

BioPort spokeswoman Kim Brennen Root said her company considers the BioThrax vaccine as fully licensed and validated by the FDA.

"Our license is in place regardless of the route of exposure," she said. "I don't think it's the judgment of any of the appropriate agencies that this is an investigational vaccine."

She said the emergency request from DoD is a mechanism that can be used to resume the military's vaccination program.

Emergent BioSolutions Inc., the parent company of BioPort, recently announced the acquisition of a 150,000-square-foot facility in Frederick, Md, which will be used as an additional vaccine manufacturing site. Brennen Root said the facility is being designed to produce multiple vaccines. The company is waiting, however, for contracts before it begins production at the center.

HHS announced in November that it plans to buy 5 million doses of the BioThrax vaccine for civilian inoculations. Brennan Root said the company expects a contract for actual work to be let early next year.

HHS also awarded another contract in November worth almost $880 million to VaxGen Inc. of California to produce 75 million doses of a new type of anthrax vaccine.

News

2004-12-14T16:47:00.000-08:00

Defence officials have signed a $2.9-million deal with a U.S. firm to develop an anti-anthrax inhaler that could be available for civilian as well as military use.

Aradigm Corp. of California will spend the next few years developing and testing a puffer to counter the effects of anthrax and other biological warfare agents. The inhaler, conceived by Defence Department researchers, will contain the powerful antibiotic ciproflaxacin. "The initial target population was military use," said Maj. Don Van Loon, a bio-science officer.

"However, this is a drug product that will have dual-use potential."

That means the new technology could be used to administer other drugs. The anthrax form will be commercially available to the public if there is a demand for it.

more

Experts critique anthrax-vaccine plan

2004-12-11T13:58:00.000-08:00

In ordering a new $877 million anthrax vaccine last month, the federal government said it was a major step toward creating a "bioshield" to protect Americans from germ warfare. But delivering that protection could be difficult: The vaccine is unproved in humans, the manufacturer has legal and accounting troubles, and health officials are not prepared to distribute the vaccine quickly if it is needed.
Bush administration officials, as well as the top executives at VaxGen, the manufacturer in California, say they are confident they can fulfill their promise.

"This program needs to be a success for all of us -- the federal government, for the company and for the American public," said Lance K. Gordon, VaxGen's chief executive.

But some scientists say the effectiveness of the vaccine, which is to be delivered starting early in 2006, is still in doubt.
more

Paper concludes squalene is in Vaccine

2004-11-29T04:57:00.000-08:00

Through my own personal research I have discovered that many people still have doubts that their own government would blatantly do something like test its own people. My goal now is not to make you think this is true but to give you info and make you have your own opinion. It is true that squalene is an adjuvant, but no one has demanded explanations. A letter was sent to Rumsfeld and he was to answer by 11/19 and still no answers. Please read this paper and find out more

Gulf syndrome is beyond doubt, inquiry finds

2004-11-25T10:53:00.000-08:00

The Government should "publicly acknowledge" that 6,000 British veterans are suffering from Gulf war syndrome and set up a fund to compensate them, an independent inquiry concluded yesterday.

The inquiry, chaired by Lord Lloyd of Berwick, a former law lord, said it was "beyond reasonable doubt" that Gulf war veterans were likely to develop illnesses over and above those they might expect if they had not gone to war.

The Government had originally indicated that it would accept that the illnesses affecting the veterans resulted from service in the Gulf if proper medical studies showed there to be an increased risk among Gulf veterans, the inquiry said.

There had now been three authoritative UK studies into Gulf war syndrome, two funded by the MoD and one by the US government, all of which concluded that troops who went to war were twice as likely to become ill as those who did not.

"The Government ought now, in fairness, and not before time, to accept that the illnesses were caused by their deployment," the inquiry said.

read more

ARE WE BEING SET UP FOR ANOTHER GULF WAR SYNDROME DISASTER?

2004-11-21T10:50:00.000-08:00

An Open Letter to Those Offered Vaccines by the US Government

by Jerry Leonard (jerryleonard999@yahoo.com)

To counter the latest “terrorist” threats, the government has announced elaborate plans to vaccinate the American public (forcibly if necessary) against smallpox and anthrax. If you are contemplating taking government vaccines to “protect” yourself or your family, please considering the following:

Numerous researchers have traced Gulf War Syndrome–an affliction affecting thousands of American soldiers–to unethical testing conducted by the US government using experimental anthrax vaccines and other treatments during the first Gulf War.

Upon closer examination, a scenario comes into focus which is even more disturbing than government experimentation on hundreds of thousands of its troops. Recent press reports have shown that this experimentation under the first Bush administration was conducted under the guise of protecting US troops from an enemy the US not only created but gave bioweapons.(1) Robert Novak explained in the Chicago Sun-Times:

An eight-year-old Senate report confirms that disease-producing and poisonous materials were exported, under U.S. government license, to Iraq from 1985 to 1988 during the Iran-Iraq war. Furthermore, the report adds, the American-exported materials were identical to microorganisms destroyed by United Nations inspectors after the Gulf War. (2) [emphasis added]

Although hundreds of thousands of Gulf War soldiers developed complications as a result of the vaccines and chemicals(3) they were given by the US government, investigations into why they got sick have been seriously hindered. One reason for this is that the very same people who armed Iraq with bioweapons were put in key positions supposedly investigating US soldiers’ exposure to biowarfare agents during the war.(4) Another reason is that the government just does not want its troops to know the details of how they were used as experimental guinea pigs for the pharmaceuticals industry.

Round Two
Now the government is again offering vaccines to “protect” not only its troops but the public at large from Iraq and another enemy it helped create… Bin Laden and his terrorist network. This time it is George H.W. Bush’s son, George Bush III—a business partner of the Bin Laden family,(5) leading the charge.

The more things change…

While the US government initially attempted to blame Iraq and/or Bin Laden’s terrorist group as the source of anthrax in “terrorist” attacks on the US, it has been revealed that the source of the disease, once again, appears to be none other than the US government itself. The New York Times reported:

The dry powder used in the anthrax attacks is virtually indistinguishable in critical technical respects from that produced by the United States military before it shut down its biowarfare program, according to federal scientists and a report prepared for a military contractor.

Obviously, the government’s claims that it shut down its bioweapons program decades ago are false.(6)

While the goal of the second Gulf War is transparent enough,(7) given the disastrous results of the use of experimental vaccines in the first Gulf War, one wonders what the rush is to give admittedly dangerous vaccines(8) to the public to “protect” it from US-manufactured enemies(9) and biowarfare agents. It is tempting to postulate that a justification for unethical experimentation is being carefully constructed through the deliberate creation of “enemies.”

Was the Gulf War Syndrome that devastated US troops just a warm-up for a wider experimental project aimed at the American public? Are there hidden benefits to these experimental vaccine programs—as harmful as they may be to the vaccine recipients?

The Benefits

I have completed a study showing that these experimental vaccines are indeed beneficial to certain government agencies and private industries because they are being covertly used as experimental vehicles to achieve hidden economic and political goals. In my book AIDS: The “Perfect” Disease, I summarize the evidence that one manifestation of the Gulf War Syndrome was caused by experimental AIDS vaccines secretly tested by the government during vaccination of its Gulf War troops. I also show how the outbreak of the AIDS epidemic itself has been traced to experimental vaccines and is fulfilling the goals of cancer vaccine researchers—the same group that injected human subjects with monkey cancer viruses and isolated and grew immunosuppressive viruses in human cell cultures(10) just before AIDS conveniently broke out in human populations.(11)

While Gulf War Syndrome has been traced to an experimental anthrax vaccine, the international AIDS epidemic has been traced to a smallpox vaccine program covertly used as a cancer experiment. Oddly enough, the smallpox and anthrax vaccines are the very same vaccines that the government is now pushing the public to take!

Is it not curious that world events have been shaped by persons connected with CIA operations such that taking these vaccines can be presented to the public as not only in their best interest but necessary for their very survival?

Recent history should prod us to ask whether the war against terrorism or another war against Iraq will be used, as the first one was, to continue the long-term program of experimentation on US citizens by pharmaceuticals corporations through the government using vaccines.

The right people are in place to use the government for just such a self-serving scenario. For example Secretary of Defense Donald Rumsfeld, who helped orchestrated the arming of Iraq in the 1980s,(12) is conveniently in a position to oversee “defense” contracts handed out to well-connected vaccine manufacturers(13) in response to terrorist threats he helped create. And Rumsfeld, as a former multinational pharmaceuticals company executive and lobbyist, (14) now back in “public service” overseeing the defense establishment, is in position to oversee human testing of biowarfare countermeasures on a captive population by the government on behalf of the pharmaceuticals industry.(15)

With high-level lobbyists like this, it is no wonder that outrageous legislation conveniently benefiting the pharmaceuticals industry was placed in the Homeland Security Act.(16) The “war against terrorism” has provided the vaccine manufacturers with an ideal scenario--an increased demand for their products (including mandatory vaccination clauses), relaxed laws on human experimentation with these products and legal protection against lawsuits resulting from any side-effects from this experimentation.(17)

So the stage is set: the vaccine manufacturers have learned the lesson of the first Gulf War. Now they have license to experiment on the public through the government with impunity. And they have the perfect vehicle with which to do it. Advances in genetic engineering have made the smallpox vaccine one of the best vehicles imaginable for sophisticated and covert vaccine experimentation.(18) Simultaneously, these advances in genetics have made it unlikely that existing smallpox vaccines would even be useful against “weaponized” versions of smallpox. When considered together, these facts make the current rush towards mass vaccination against smallpox appear much more suited for public experimentation than public protection.(19)

Additional cause for concern lies in the documented history of unethical experimentation using smallpox vaccines. Such experimentation was conducted from the beginning by its “inventor”(20) and has more recently been tied to the outbreak of AIDS. Moreover, the US government--which would be overseeing the smallpox vaccination of the US public--has a history of using vaccines for experimental purposes other than those stated and, more specifically, using smallpox for unethical purposes against defenseless populations.(21)

Robert Novak recently warned: “Looking at a little U.S.-Iraqi history might be useful on the eve of a fateful military undertaking.” I would add that looking at a little US history regarding human experimentation with vaccines, especially those administered at the outset of the last Gulf War, would be useful on the eve of mass-vaccination efforts by the government in conjunction with a second Gulf War.

In light of recent “terrorist” attacks with biowarfare agents traced back to the same U.S. government which armed Iraq and created Bin Laden, I believe widespread knowledge of the history of these experiments is vital to prevent a repeat of the Gulf War Syndrome on a wider scale through government vaccine programs administered to fight alleged terrorist attacks. My concerns are summarized in greater detail at: www.winstonsmith.net.

Please review the author’s findings regarding the uninterrupted program of experimentation on US citizens by their government and consider whether the risks of taking the government’s vaccines outweigh the stated benefits.

Disclaimer: This information is not to be construed as medical or legal advice. This article was written to assist you in making an informed choice. The decision on whether to vaccinate or not is yours alone.

Iowa GI’s painful death builds the question: Did the government and military lie?

2004-11-21T10:42:00.000-08:00

By STEVE WEINBERG
SPECIAL TO THE REGISTER
November 21, 2004
fter U.S. Army Sgt. Scott Siefken returned from the 1990 Gulf War waged by the first President George Bush administration, his ailments puzzled his Iowa physicians.

Siefken served with the National Guard 1133rd Transportation Company based in Mason City. His body temperature fluctuated inexplicably, rashes appeared all over his body, lesions formed in his mouth so that he could not chew food, and he lost 40 pounds.

Veterans Administration doctors in Des Moines sent him to Iowa City, where specialists peeled away his skin, which seemed to be burning off his body. Nobody could touch him, not even his wife, because infections might result. Two years after returning, Siefken died at age 37.

Military authorities refused to release immunization records. But it seems quite likely that Siefken received a vaccine from the Army intended to prevent anthrax poisoning.
read more

TRI Sues Donald Rumsfeld & U.S. Military on Behalf of Air Force Sgt. Punished for Speaking Out About Tainted Anthrax Vaccine

2004-11-20T06:30:00.000-08:00

WILMINGTON, Del.?Attorneys for The Rutherford Institute have filed suit in federal district court on behalf of the First Amendment rights of Air Force Sergeant Jason Adkins, who was sanctioned after reporting to sick call and voicing concerns that he could be suffering the ill effects of a tainted anthrax vaccine administered to select military personnel. Sgt. Adkins is a 14-year decorated airman who served on the first C-5 aircraft flown into Baghdad in the recent Iraq War and other numerous classified special operations missions. The suit, which names Adkins? supervisors in the Air Force, as well as James Roche, the Secretary of the Air Force, Secretary of Defense Donald Rumsfeld and others, was filed in federal district court in Wilmington, Del., by Institute affiliate attorney Thomas S. Neuberger of the Neuberger Firm. The complaint alleges that for five years the Department of Defense has subjected select military personnel to a dangerous experimental anthrax vaccine with life-threatening and debilitating side effects. Despite the DOD?s insistence that the anthrax vaccine is safe and effective, a federal judge recently ordered the Pentagon to halt the mandatory vaccination program. read more

Air Force Sergeant Sues Over Anthrax Reprimand

2004-11-19T20:58:00.000-08:00

By Patrick Mairs

WILMINGTON, Del. (Reuters) - An Air Force flight engineer charged in a lawsuit on Thursday that the U.S. military violated his civil rights when it punished him for complaining about the dangers of the anthrax vaccine.

Staff Sgt. Jason Adkins said he was punished last month when he told an Air Force doctor he believed the controversial vaccine was causing a host of medical problems, according to the federal suit filed in Delaware.

Adkins, who is stationed at Dover Air Force Base in Delaware and is a flight engineer on C-5 aircraft, named Defense Secretary Donald Rumsfeld and other Air Force officials in the lawsuit.

Adkins has suffered from memory loss, severe headaches, weight loss, constant body aches and an irregular heartbeat since receiving eight mandatory anthrax inoculations between 1998 and 2004, according to the lawsuit.

The Pentagon (news - web sites) had no immediate comment on the content of the lawsuit but called the vaccine safe and effective, a spokesman said.

A federal judge last month barred the U.S. military from forcing troops to be vaccinated for anthrax without either getting their informed consent or obtaining a special order from President Bush (news - web sites).

About 1 million troops have already been given the shots in the 6-year-old program, and many who refused have faced punishment, including being thrown out of the military.

Adkins' lawsuit seeks a court order preventing future retaliation and an apology for the written reprimand the staff sergeant was given last month.
more

New hope for Gulf veterans as report backs their claims

2004-11-18T09:23:00.000-08:00

Dave Mark
After yesterday's independent report called on the Government to recognise the existence of Gulf War Syndrome, Dave Mark asks 'what now' for the campaigners, and, right, looks at the case of a Yorkshire soldier now using a wheelchair after serving in the conflict
New hope for Gulf veterans as report backs their claims

IN FEBRUARY this year, solicitors representing the hundreds of Gulf War veterans fighting to prove the existence of a mysterious syndrome told their clients the case was unprovable.
The legal team, which had been investigating the strength of the case for six years, told the Legal Services Commission (LSC) that there was not enough scientific evidence to prove exactly what caused the illnesses – pulling the plug on legal aid funding. more

Anthrax vaccine blamed for illness

2004-11-17T07:21:00.000-08:00

Anthrax vaccine blamed for illness
Book claims Gulf War GIs were guinea pigs

By Bartholomew Sullivan
sullivanb@snhs.com
November 17, 2004

WASHINGTON -- Mark Ammend of Collierville can't talk about it now.

The former fire chief for the 164th Air National Guard unit based at Memphis International Airport got vaccinated against anthrax five years ago. Now, as he lies in a specially designed bed, the only thing he can move is his left eye.

Fully conscious and aware, Ammend, 55, is a quadriplegic with amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease.

A new book suggests he and many other soldiers immunized against anthrax during the 1991 Gulf War and since are suffering auto-immune diseases after receiving an illegal chemical adjuvant -- a chemical designed to boost the immune system -- called squalene.

The Pentagon adamantly disagrees and insists that the vaccine is safe.

In his just-published "Vaccine A: The Covert Government Experiment That's Killing Our Soldiers and Why G.I.'s Are Only the First Victims," author Gary Matsumoto suggests Memphis was the key to the immunological puzzle.

"The whole idea originated in Memphis," he said in an interview.

That idea came from Pamela B. Asa, a former Memphis immunologist now living in Tupelo who collaborates with Robert F. Garry, a professor of microbiology at the Tulane University Medical School in New Orleans. Asa and Garry made the connection between squalene, which has not been authorized for use in humans in the United States, and what has been called Gulf War Syndrome in an article in Experimental and Molecular Pathology in 2002.

Auto-immune diseases such as ALS, lupus and rheumatoid arthritis are chronic and increasingly debilitating. They occur when the body can't distinguish between itself and foreign substances it's supposed to attack. Thirty years of scientific literature has shown squalene and other oil adjuvants have induced auto-immune-like illnesses in four species of lab animals. Squalene has never been licensed for use in humans in this country, although it is an element of a variety of experimental drugs.

Asa began looking into the connection between the constellation of symptoms associated with the soldiers' syndrome in 1994, and went to the Pentagon with her concerns. She said she found that many of the soldiers complaining of rashes, fatigue, blackouts, seizures, and joint and muscle pain looked like they had systemic lupus erythematosus, a multi-symptomatic auto-immune disease.

She monitored discussions on Gulf War Syndrome chat rooms, and recommended medical tests that those who were suspicious about their health might take. Word got around, and some shared seriology data with her.

Matsumoto wrote about her suspicions for the first time in 1999, in Vanity Fair magazine, prompting some soldiers in bases around the country to protest taking their anthrax shots. Many others soldiered on, and took them.

At least four members of the 164th Air Guard unit in Memphis quit in 1999 rather than take the shots. But more than 800 took them, according to unit officials at the time.

Ammend, the Air Guard fire chief in Memphis for 11 years and a soldier since 1972, took his first anthrax shot in 1999. He took the last one in April 2000. In 2002, he could still walk, his wife, Mary, said Tuesday. He now lies, mouth open, in his living room, on a respirator 24 hours a day.

"I understand why it was done, or why it was needed," Mary Ammend said. "But I just feel it could -- there should have been more care taken for the FDA to study it before they started dishing it out to the guys."

Three members of the 164th ANG unit in Memphis approached Asa after the Vanity Fair article and asked her to test their blood for antibodies to squalene before they were administered their mandatory anthrax shots. Before the shots, they had no antibodies to the substance. Afterward, two did.

One of them was Sgt. Serge Trullet of Ripley, Miss. A naturalized citizen from Argentina, Trullet wouldn't disobey an order to take the shot, but he wanted to take precautions, he told Matsumoto. When he tested positive for the antibodies to squalene, then started getting a rash and swelling, he didn't blame Uncle Sam. He blamed the unknown people "somewhere along the line," who let it happen.

"I don't know what to think about my commanders," Matsumoto quotes him saying. "I think that they're just ignorant -- you know, 'follow the leader' types that absolutely question nothing that their superiors tell them. I feel that some of them would have probably done the same things that the Nazis did to the Jews with the excuse that they were just following orders." Trullet did not respond to phone calls from The Commercial Appeal Tuesday.

"This (squalene) has not been out in the public forum because the Department of Defense has sort of blown it off and tried to portray people who spoke about it as conspiracy nuts," Asa said in an interview Tuesday.

"Had they (soldiers) not been given this stuff, we would not be finding antibodies to it in people who are sick with auto-immune diseases that squalene has been chronicled to cause for decades."

It's complicated science, but Asa and Matsumoto maintain that the squalene was used experimentally to boost the immune response to a very weak vaccine prepared to ward off a bio-chemical attack of weaponized anthrax spores known to have been developed by Saddam Hussein before the first Gulf War.

Over the years, symptoms of Gulf War illness have been blamed on stress or nerve gas exposure, flea collar insecticides and other factors, but anthrax vaccine has usually been among them. More than $100 million has been spent to find its cause.

James Turner, a Department of Defense spokesman specializing in health matters, said Tuesday that he was familiar with Matsumoto's book but called the concerns it raises "an old, old issue" being pushed by his publisher. Turner directed specific questions about anthrax and squalene to a department Web site. The site acknowledges that the Food and Drug Administration found squalene in some vaccines for anthrax, but says the amount was probably from fingerprint contamination by lab technicians and too small to cause concern.

Before ending the call, Turner added: "The fact is that we do not put squalene in our vaccines and never have. ... The notion that we're using military people as guinea pigs without their knowledge is absurd."

Absurd or not, it is Matsumoto's most explosive claim, and it's backed by Asa. He says in the book that FDA tests show that the amounts of squalene found in different "lots" or batches of the vaccine administered to some troops shows a pattern. That pattern establishes someone was trying to determine the response to a progression of different doses, he claims.

"This is an experiment," Asa said Tuesday. "This is a dose-range experiment."

Perhaps the strangest set of facts revealed in his exhaustive history of anthrax's use as a potential weapon is Matsumoto's claim that the vaccine administered to soldiers might protect against anthrax encountered by contact, but would never work effectively against inhaled anthrax spores such as the threat foreseen from Saddam.

Asa agrees, and so does a federal judge in Washington. U.S. Dist. Judge Emmett Sullivan ruled Oct. 27 that the mandatory use of anthrax vaccine on soldiers is illegal and must stop because authorities can't prove it actually works against the inhaled anthrax expected to be used as a weapon in wartime.

Since the mid-1980s, the FDA had never found the vaccine effective in other than occupational settings, such as for protection of workers exposed to infested animal hides. But in December 2003, after the mandatory inoculations had been under way for five years, the FDA found that the vaccine was effective for inhaled anthrax. Sullivan said the agency failed to follow its own protocols in reaching that conclusion and ruled the vaccine can be used only in the case of informed consent or a presidential waiver.

Asked Tuesday why the Pentagon would want to vaccinate soldiers with a shot that couldn't accomplish its purpose, Asa said she doesn't know. But in her decades of research, she knows the Department of Health and Human Services has been looking for an oil adjuvant to boost potential anti-AIDS vaccines. She says agency researchers are trying to "make the science fit their wish list."

Help abolish the feres doctrine.

2004-11-17T07:05:00.000-08:00

The feres doctrine is a policy that was instituted in 1950 or so it argues that...
The United States is not liable under the Federal Tort Claims Act for injuries to members of the armed forces sustained while on active duty and not on furlough and resulting from the negligence of others in the armed forces. Due to this, Soldiers, sailors, airman, whom become ill due to vaccinations can not seek damages of the injuries caused. In order to seek damages we must abolish the feres doctrine. To sign a petition for this click here

Colo. mother waging war on military's anthrax shot and she not alone.

2004-11-15T11:10:00.000-08:00

When the news she had waited years to hear finally arrived, Lori Greenleaf was strangely unmoved.

A federal judge had ordered the military to stop forcing soldiers to be injected with an anthrax vaccine. But while the court had essentially said last month that Greenleaf was right about the vaccine's problems, she didn't feel like a winner.

"It's bittersweet because I don't think it'll hold," said the woman described in a recent book as the "Dear Abby of Anthrax Vaccine." "And all the people they hurt already don't get any restitution. I surely do hope the judge's order stands, but we've had so many disappointments you hate to get your hopes up."

Greenleaf, 46, of Morrison first took issue with the anthrax vaccination program five years ago when her son became one of the first sailors to receive it
more

C-5 pilot refused shots, became target

2004-11-14T22:10:00.000-08:00

DOVER -- When a federal judge recently halted the military's mandatory anthrax vaccine program, Air Force Reserve Capt. Paul Staquet assumed his troubles had ended.

He was wrong.

The day the judge ruled, Staquet, a 33-year-old C-5 Galaxy pilot assigned to Dover Air Force Base, received a letter in the mail from his commanding officer. "I have initiated administrative separation actions against you," the letter stated.

In other words, Staquet's military career is over, and no federal judge or a ruling that the anthrax vaccine program be suspended will exonerate any military personnel in trouble for resisting the Defense Department's controversial vaccination program. Even at Dover, where tainted vaccine has heightened fears that the shots attack human immune systems.

Staquet is facing a bad-conduct discharge at a later date for refusing to submit to all six anthrax vaccinations - a sanction likely to destroy his military career and damage his future civilian career.

Staquet says he was targeted by his superiors the instant he refused the vaccine.

"It's punitive," Staquet said. "It's all because of the anthrax vaccinations. I know the science. The shot is not safe! More

Military Abuse of authority

2004-11-14T06:44:00.000-08:00

Army Times - November 15, 2004

Military abused its authority in anthrax vaccine program

By Russell Dingle and Thomas Rempfer

In 1776, our Founding Fathers signed the Declaration of Independence, in part due to abuses of authority whereby the occupying military power had become “independent of and superior to the Civil Power.”
The founders ensured through the Constitution that our new nation’s military would remain firmly under civilian control. As the scope and technology of our armed forces evolved, civilian leaders became increasingly reliant on the military leadership’s integrity and expertise in the profession of arms.
This reliance was based on the leaders’ commitment to give unbiased assessments of threats, weaponry and force protection. Anything less from the military is a dangerous trend — one our forefathers decisively rejected.
The military’s anthrax vaccine program, however, is a case study of inaccurate assessments to our civilian leaders. Military officials often unknowingly misled appointed civilian superiors with dogmatic rhetoric, delaying the proper execution of Congress’ oversight role.
Regardless of where accountability lies for the misinformation, the fact is the military implemented the immunization program based on false assumptions about the safety, efficacy and legality of the vaccine. Adverse reactions were a hundred times higher than originally professed, and the vaccine’s experimental status rendered the mandatory program illegal. These facts were not communicated with candor.
Despite delays in the oversight process due to this lack of forthrightness, civilian control of the military remained steadfast. In February 2000, Congress released a report finding that the vaccine was indeed experimental. It recommended developing a modern vaccine while making inoculations voluntary, in line with federal law. The Government Accountability Office, formerly the General Accounting Office, also published more than a dozen critical reports.
In December 2003, a federal court upheld the anthrax vaccine to be an “investigational drug … being used for an unapproved purpose,” and affirmed that the Pentagon “is in violation of 10 USC 1107, Executive Order 13139, and DoD Directive 6200.2.” The court commented on the assertion that the vaccine was not experimental, stating: “The documents submitted to this court under seal suggest otherwise.” The court accurately recognized that the Defense Department had considered the vaccine “experimental.”
Regardless of a belated attempt to complete the anthrax vaccine’s licensure by the FDA after the court’s ruling, the program’s past illegality stands as case law to this day. On Oct. 27, the federal judge reaffirmed his decision that the anthrax vaccine program is illegal absent informed consent or a presidential waiver.
The Pentagon’s internal documents, the congressional report and the federal court ruling confirmed the vaccine’s known experimental status. The law explicitly required either a service member’s informed consent for such a vaccine or the president’s waiving of this right.
Unfortunately, the Defense Department did not modify the anthrax vaccine program in its early stages, when the illegal program affected only a small portion of the armed forces. Instead, federal regulations, U.S. law and attempts at civilian control were dismissed.
Today almost 5 million doses of vaccine have been mandated for more than 1.2 million troops.
So is civilian control of the military at peril with regard to the anthrax vaccine program? Clearly, the answer is no. The congressional reports and legal opinions attest to ongoing efforts that will ultimately reaffirm civilian control of this program. The oversight is not as expeditious as many who have lost their careers or health due to the vaccine mandate might have hoped, but the process continues.
For example, legislation was recently introduced in Congress to make the anthrax vaccine program voluntary and order the correction of records for troops previously punished over their concerns about the vaccine. Exoneration for those fined, dishonorably discharged or even jailed should be an academic exercise based on documented historic violations of law.
Ultimately, the military itself should hold accountable the officers who misled our civilian authorities and armed forces about the anthrax vaccine mandate — enforced at the expense of thousands of punished and ill service members.
Retired Lt. Col. Russell Dingle and Maj. Thomas Rempfer were members of a 1998 Connecticut Air National Guard investigative team that helped identify legal and ethical issues regarding the anthrax vaccine. Their views do not represent official Defense Department policy.

Radio Interview

2004-11-12T05:43:00.000-08:00

Many people have viewed this blog and recieved quite a bit if insight. I will always continue to improve this page as it is for info and more. I will be on the radio (station website)in New Rochelle , NY today discussing the effects of this vaccine and why it must stop. Here is a link to the pdf of the actual injuction, by Emmet Sullivan. That forced the government to stop the Anthrax vaccination program. See it here

UAB gets $12M contract for anthrax vaccine study

2004-11-11T15:56:00.000-08:00

The University of Alabama at Birmingham has received a five-year, $12 million contract from the National Institute of Allergy and Infectious Diseases, to study genetic factors that influence how well individuals respond to the anthrax vaccine. "This research will provide valuable information about individual differences in immune response and in adverse reactions to the anthrax vaccine," said Dr. Richard Kaslow, professor of epidemiology in UAB's School of Public Health.
The national anthrax vaccine trial, funded by the Centers for Disease Control and Prevention, is aimed at determining whether the vaccine is equally safe and effective when injected into muscle rather than under the skin. It also examines an altered dosage schedule.
UAB is one of six medical institutions across the country contributing to the trial. full story

Military Vaccine Education Center, Military Vaccine Action Committee, Veterans Groups, Vaccine Groups Respond to Halt of Anthrax Vaccine

2004-11-10T10:45:00.000-08:00

MISSOULA, Mont., Nov. 10 /PRNewswire/ -- The Military Vaccine EducationCenter (MVEC) and the Military Vaccine Action Committee (MVACPAC), as well asthe following organizations, join together to fully endorse DC FederalDistrict Court Judge Emmett Sullivan's ruling declaring the anthrax vaccineprogram to be illegal without informed consent or a Presidential waiver.Recognizing that the vaccine has long been illegal and that public input hasnot been allowed in the process, Judge Sullivan has saved the lives and healthof countless troops with his ruling. There is much work yet to be done. We call upon the Dept. of Defense toimmediately clear the names and records of those who have refused the vaccineby restoring their military rank, pay, and status. We also call upon theDefense Department to cease and desist their historic pattern of dishonorablydenying that the illnesses of the troops are connected to military medicine.Instead the troops must be afforded proper medical care, without being accusedof being malingerers. We call upon our government officials and all citizens to remember thatour constitution calls for civilian control over the military. Werespectfully remind the Congress that they are elected to stand up for thetroops, while providing direction, leadership and oversight to the DefenseDepartment, not the other way around. more

Tainted Lot numbers

2004-11-09T09:53:00.000-08:00

If you know you have been given anthrax from any of these lots please contact me. I am here to help and your info remains confidential.

To All: Based on data from Tulane University Medical School, and medical records submitted by military personnel to Dr. Asa, this the complete list the vaccine lot numbers that Tulane considers problematic (I forgot to mention three of them in earlier postings):

Squalene-Positive [per FDA and SRI]:
FAV 008, FAV 020, FAV 030, FAV 038, FAV 043, FAV 047

Have Induced Anti-Squalene Antibodies [per Tulane Med School]:
FAV 041, FAV 070 and FAV 071

Associated with Autoimmune-Related Symptoms or Fullly Diagnosed Autoimmune Diseases in Troops [per Tulane]:
FAV 017, FAV 048b, FAV 066, FAV 068, FAV 069, FAV 073, FAV 074, FAV 075, FAV 078

I recommend directing any questions concerning this data to either Dr. Pamela B. Asa or Dr. Robert F. Garry.

Makers of the Anthrax Vaccine Make a Deal with the Government

2004-11-09T06:15:00.000-08:00

It was in September 2001 that letters laced with anthrax powder were mailed to political and media targets in Florida, New York, and Washington. Five people died, and soon after, the anthrax vaccine was offered to military personnel. One that medical personnel knew could have side effects, but it was the best they had to offer at the time.
Latest news is here on new Vaccine

Now, Vaxgen, the maker of a new anthrax vaccine, announced on Monday that it has signed a contract with the government to produce 75 million doses over the next three years. Here's the best news. This new vaccine can be given after exposure or before.
"Once delivered to the stockpile, the intention is it will be held under the control of the Centers for Disease Control to have that vaccine available for emergency use if there is another release in the field like we had in September 2001," says Carmen Belan, Vaxgen.
The Vaxgen anthrax vaccine is expected to be available to the public eventually, but for now, it has not been approved yet by the FDA for anything other than use through the government.

Answer to post question.

2004-11-07T17:34:00.000-08:00

Here is an original question presented on the blog and the response from one of our experts.

Have their been any reports of loss of short-term memory. I talk regularly to some soldiers wives reagarding an event we are producing for the military familes and they are sharing with me stories of their husbands suffering from severe short-term memory loss since returning home from their first tour of duty.The one thing they suspect it may be a result of is their smallpox vaccine which they recieved twice, since the first batch was mixed improperly. Have you heard any reports of this?Besides the health issues involved, this is dangerous since they are re-deploying to Iraq in one month.
Respectfully,
Chris Thompson
www.citizenshelpingheroes.org

Reply post

This short-term memory problems have occurred in first GW war vets who came home sick (or never deployed due to autoimmune illnesses and were still positive for antisqualene antibodies, just like the ones who did deploy and got sick), AVIP anthrax vaccine recipients who received lot numbers which FDA confirmed contained squalene. Squalene is known to cause autoimmune neurological disease which can affect memory as well as balance, sensory and motor functions. Squalene has also been proven to cause rheumatologic diseases such as lupus which can affect CNS functions with seizures, cerebritis, antiphospholipid antibodies (which cause blood clots and can affect circulation anywhere in the body), and vasculitis (which can affect circulation anywhere in the body.) These things can happen without having lupus as well. I encourage folks who have these problems to see their physicians for check-ups to include the tests which look specifically for autoimmune diseases. They may also need further tests such as EEG's or MRI's. I hope this information helps and wish all of them the best.

Communication between Author of Vaccine A and Washington Post reviewer, Dr Moreno.

2004-11-07T06:32:00.000-08:00

The following are posts written to each other after Dr. Moreno reviewed Vaccine A on the Washington Post. These are actual words nothing has been changed. Read and determine for yourself.

Posted: Sun Nov 07, 2004 5:38 pm Post subject: Reply to Dr. Moreno's Follow-Up Response

Dear Dr. Moreno:

Please allow me to reiterate my belief that you are an honorable man and that your criticisms of Vaccine A were made in good faith. You are clearly an eminent scholar who is, even as we disagree on substantive issues concerning my book, doing important work in the service of U.S. military personnel. For your research on the DOE human radiation experiments, Project Shad and more, may I be among those who most loudly applaud your past and present efforts. I know that I am, along with the men and women in serve in the U.S. armed forces, a beneficiary of your work. All my nieces and nephews are now draft age; one nephew in is in the Marine Corps awaiting deployment to Iraq. If I have appeared ungracious towards Mr. Butterworth or Laurie Garrett in my book, then I apologize, but only about my tone. In general, it is not easy to criticize without such criticism appearing unduly harsh. However, criticize I must, because their errors were intentionally amplified by DOD's wide dissemination of their attacks on the Vanity Fair article, which were distributed to members of Congress and the media. Having spoken to Mr. Butterworth on more than one occasion, I believe that he, too, was well meaning in his attacks on Vanity Fair, and acted in good faith. Nevertheless, I believe his assertions, which are still being trafficked on the Internet, required rebuttal for the benefit of those people who've been injected with squalene in the past, and those at risk of being injected with it in the future. All this could be settled if selected DOD and DHHS officials be forced to answer, under oath, and before a committee whose members have no ties to the defense or pharmaceutical industries, these two questions: (1) Did DHHS grant DOD a waiver of informed consent for the testing of the second generation anthrax vaccine on military personnel, or, in a separate protocol, the testing of squalene emulsion adjuvants on military personnel?; and (2) Did DOD defy existing requirements for such a waiver and administer IND drugs and vaccines to U.S. troops with the best of intentions, but in error? Then, as with the DOE documents on the human radiation experiments, all the DOD and DHHS documents regarding the testing of oil adjuvants on troops (Incomplete Freund's Adjuvant and squalene emulsions), should be declassified and released, unredacted, to the public. It does not help if scholars such as yourself remain tepid on this issue; or worse, balk at it. Even GAO investigators, investigators with the Senate Veterans' Affairs Committee and members of the House Government Reform Committee have complained about DOD and FDA stonewalling and obfuscation on the matter of squalene. Because classified clinical trials on troops lack accountability and are open to corruption, I believe the practice of running such experiments without informed consent should stop. To inject accountability into this system, the Feres Doctrine should be reinterpreted or scrapped, and reparations should be paid to those military personnel who've been harmed by these injections.

Sincerely,

Gary Matsumoto

Dear Mr. Matsumoto,

Thank you for your reply. I have never made any secret of my affiliations, paid or unpaid. I hope in your posting you will note that my work on the human radiation experiments controversy 10 years ago helped result in uncovering decades of federally supported research; that I published the first and only comprehensive history of government atomic, biological and chemical experiments since World War II; that I am the only bioethicist to have written about the exposure of sailors and soldiers to nerve agents during the 1960s ("Project 112" of SHAD); that my uncompensated service on the National Research Council's committee to review the Pentagon's radiation dose reconstruction has contributed to an overhaul of that program and fairer assessment of the veteran's' exposures; and that my current projects include a book on the threat that national security neuroscience research poses to our civil liberties and further threatens traditional limits on the exposure of civilians to weapons of war. I look forward to seeing this information on your website. I wish you best of luck in your work.

Post subject: Follow-up Reply to Dr. Moreno from G.M. on WashPost Review

Dear Dr. Moreno:
Thank you for taking the time to respond. In fairness to you, and in the interest of accuracy, I am going to post your objections to my email on the [i Vaccine A[/i] website. I assumed that being a member of the "Board on Health Sciences Policy of the Institute of Medicine (National Academy of Sciences)" and a "Special Expert in the Department of Clinical Bioethics at the Warren Magnuson Clinical Center of the National Institutes of Health in Bethesda, Maryland" constituted "close affiliations." While that's close enough for me, I will no longer use the adjective "close" when referring to your ties to these agencies. That being said, I believe paid consultancies are not the only things that can interfere with one's objectivity. I do not necessarily see us on opposing sides, but I think it's fair to say that you gave fifty-seven pages of footnotes and bibliographic references rather short shrift by devoting so much space in a review (with limited column inches) to your perception that my pointed attack on Trevor Butterworth and virtually non-existent criticism of General Russell were simply injudicious paybacks. DOD used Trevor Butterworth's irresponsible criticism of my 1999 Vanity Fair article to short circuit any discussion on this matter. DOD circulated Butterworth's critique to members of Congress (GAO officials told me it was sent to every member of the House). Rebutting his analysis is not a matter of personal vanity; Butterworth's errors, disseminated to members of our elected government, and posted on the Defense Department website for years, has had potentially harmful consequences for military personnel and, now, as I maintain in Vaccine A, for millions of U.S. civilians. Contrary to what wrote in your review, there is, in fact, barely a trace of "scientific doubt" about squalene's safety in U.S. public health circles. Conversely, there is barely a trace of "scientific doubt" about squalene's dangerous properties among laboratories overseas - some of them as prestigious as the Karolinska Institute in Stockholm. Thus, there is a patently Manichean split in scientific opinion on squalene. If there is any doubt that squalene's safety at NIH or DOD, I have never seen in it print. It's as if scientists working with squalene are laboring in parallel, but polar opposite universes. I have no doubt that General Russell meant well when he presided over the creation of the new vaccine, and later advocated its adoption. I have no doubt that Trevor Butterworth meant well when he thought he was sparing the American public the misguided reporting of a "susceptible journalist." Likewise you. I believe your intentions are honorable, as are mine. Assuming that none of us is guilty of deliberate error propogated to mislead, I think any fair-minded person would agree that error can also be the result of bias arising from all sorts of things besides money. I believe I have documented such well-meaning bias in my book. The question is when mere bias became an attempt to cover one's opulently exposed backside. For almost eight years now, squalene has been dismissed as inconsequential by the very DOD and FDA officials who have been developing the second generation anthrax vaccine containing squalene. In their dismissals, these officials have made zero mention of the new anthrax vaccine or the numerous papers documenting squalene's toxicity. Given the deep involvement of both agencies in expediting the development and licensure of the new vaccine, and DOD/DHHS's long track record of collaboration in experiments run on U.S. military personnel - including several experiments expressly organized to develop an oil adjuvant - I think it is also fair to say that, at a minimum, the evidence reported in Vaccine A merits rigorous public debate. In my opinion, your perhaps well-meaning but patronizing review, which trivializes the evidence of unethical experimentation with squalene on military personnel, discourages such debate in the very community - Washington D.C. - where it must take place. If, as you maintain, we are not in principal on opposite sides, then I think it is incumbent upon you and other bioethicists to give careful review not only to the scientific evidence for squalene's toxicity, but also the declassified DOD documents on biomedical defense from the first Gulf War. I daresay that even Henry Beecher would conclude that at least one of experiments planned for Desert Shield/Desert Storm - the one for leishmaniasis - was patently unethical. And this is only the experiment that we know about. Were there others? The clinical and forensic scientific data is evidence that there were. Yet, no one in government has made a single reference to these plans - in any federal or military investigation conducted on Gulf War illness - since veterans first reported illnesses back in 1992. Reputable scientists daring to report such data have had their work smeared as "junk science." Physicians and scientists on medical school faculties at UCLA, University of Florida, Baylor, Tulane, the Karolinska Institute and hospital, RIVM in the Netherlands and the University of Queensland and Australia - and others - have all documented the occurence of severe adverse reactions if not fully manifested autoimmune diseases in animals and humans injected with squalene emulsions, or squalene alone. Yet DOD, IOM, FDA, NIH and AFEB continue to omit any references to this data in their refutations of these allegations. It's as if it doesn't exist. These alone, are inexcusable lacunae given that NIH has already presided over numerous clinical trials with squalene. Were NIH's test subjects informed of the risks? Have they been notified after the fact? Any "fair and balanced" (to borrow a former employer's slogan) review of the evidence would discuss the extensive toxicology data on squalene, DOD's planned clinical trials for Desert Shield, the fact that most of the prototypes of the second generation anthrax vaccine contained squalene, and that NIH, FDA, IOM and AFEB have all promoted the adoption of the new vaccine, which was originally slated for the approved administration to U.S. troops as early as 1996. What's more, General Russell worked for DHHS in 1999 when six lots of anthrax vaccine containing squalene were given to troops; several scientists who either helped develop the new vaccine or worked on Project Badger are now on staff at NIH. Dr. Moreno, I believe you are an honorable man, and that you have criticized my book in good faith. Under the circumstances, however, and good intentions notwithstanding, avoiding any mention of a possible "cover-up" with regard to some of your NIH and IOM colleagues, in my view, would be excessively generous.
Sincerely,
Gary Matsumoto

Post subject: Reply to G.M. from Jonathan D. Moreno, Ph.D.

Dear Mr. Matsumoto,

Thank you for your message. I gave your book a fair review though evidently not the review you would have preferred. The pro bono work I have done on IOM and NAS committees are not "close affiliations" as I am not a member of either the IOM or the NAS. I am not now nor have I ever been an NIH employee. As you may be aware, like you I am a passionate advocate of the interests of soldiers and veterans. I served for a year and a half on a committee to review the DoD's dose reconstruction program for the "atomic soldiers." These are not "conflicts of interest" as you imply in the subject line of this message. I received no payment for this work or my current volunteeer efforts to advance public policy on stem cell research. We are not on opposing sides and I regret that you have decided to see it this way.

Jonathan D. Moreno, Ph.D.
Director, Center for Biomedical Ethics
University of Virginia Member, Board on Health Sciences Policy Institute of Medicine

Dear Dr. Moreno: The pernicious effects of injecting squalene have been proven by scientists affiliated with more than 10 laboratories around the world, including the Karolinska Institute in Stockholm and the University of Florida Medical School. Four different animal species, inoculated in various parts of their anatomy - the temporomandibular joint, the tail and the ear - have developed the animal versions of multiple sclerosis and rheumatoid arthritis, and severe neurological damage. Over the past two years, the University of Florida has demonstrated that injecting squalene can induce autoantibodies in mice that are specifically associated with systemic lupus erythematosus. The identical diseases have occurred in military personnel injected with anthrax vaccine from lots proven by the FDA to contain squalene. The autoimmune diseases diagnosed in U.S. troops correlate with the squalene-tainted vaccine lots. All this has been published in peer-reviewed scientific journals. So I think it's fair to say that the concerns about squalene's toxicity, extensively documented in peer-reviewed scientific literature, constitute a bit more than, as you put it in your review, "scientific doubt." Yet you omit all these facts from your book review. I maintain that military personnel in particular, a specific population of Americans that has been repeatedly subjected to unethical medical experimentation in the past, deserve to know all the facts about squalene, not just some of them. You state that squalene's presence in the body is "a problem" with my theory. To the contrary, as I explain at great length in Vaccine A, squalene's presence in the body is precisely why it is a problem. Loss of tolerance for a self-molecule is the essence of autoimmunity. The risks of autoimmunity by injection with self-constituents (a frequently expressed concern with regard to oncology vaccines) are well known in immunology. I have supported every attack that I made in my book, and I made many, with peer-reviewed scientific data and declassified military documents. You have attributed all this evidence contradicting DOD, FDA and IOM on this matter only to me. I am sorry; this is not only misleading, it is incorrect. I did not manufacture the data on squalene's toxicity (there are now twenty-six papers published in peer reviewed journals showing this). I did not write the papers on the neurotoxicology of sarin. I did not write the declassified Army documents spelling out the Defense Department's planned experiments for Desert Storm, or the Defense Intelligence Agency's dismissal of nerve agents as a potential cause of GWS. more

Book review in Washington Post for Vaccine A

2004-11-07T06:29:00.000-08:00

Reviewed by Jonathan D. MorenoSunday, November 7, 2004; Page BW05
VACCINE A
The Covert Government Experiment That's Killing Our Soldiers -- and Why GI's Are Only the First Victims
By Gary Matsumoto. Basic. 362 pp. $25

The history of American medical experiments with soldiers is one of ambivalence and ambiguity. Since the 1930s, high-ranking officers and civilian officials have at times foresworn the use of military personnel as human guinea pigs; at other times soldiers have been the most likely candidates to help answer scientific questions related to national security. According to one attitude these young soldiers are our best, our heroes, and must not be exploited for experimental purposes; another holds that they have already agreed to perform risky service for their country and so are natural experimental subjects. Often these views have coexisted, with one arm of the security establishment resisting the opportunity to use military personnel in medical studies while another arm takes advantage of it. During World War II, for example, the White House Committee on Medical Research decided not to approve the use of soldiers in experiments, while the Navy pushed sailors into mustard gas studies. more

Growing Doubts On Vaccine In Military

2004-11-07T05:19:00.000-08:00

With each report on the absence of weapons of mass destruction in Iraq, Airman Jessica Horjus asked a question: If inspectors could find no signs of anthrax, why should the Pentagon risk her health by requiring her to get the anthrax vaccine?
"I have a kid to take care of," said Horjus, 23, the mother of a 2-year-old, who lives with her daughter in military housing at Seymour Johnson Air Force Base in Goldsboro, N.C. "The Air Force can always fill my slot with someone else, but who's going to fill the mommy slot?"

When a January order came for Horjus to get the vaccine before deploying to a Kuwait air base about 30 miles from Iraq, the soldier with commendations and Good Conduct Medals declined. Her commander demoted her and cut her pay in half, to less than $800 a month. In February, she declined a second and third order. read more

Man Claims Anthrax Vaccine Almost Killed Him

2004-11-06T07:10:00.000-08:00

By Tiani JonesFirst Coast News

ST. AUGUSTINE, FL -- A St. Augustine man is joining hundreds of military men and women around the country, who claim the Anthrax Vaccine they were forced to take is now making them sick.24-year-old Brad Priester said after taking the vaccine he went from being a healthy, energetic young man to having dozens of medical ailments."My heart is irregular now, it's enlarged, I have high blood pressure, I have renal failure of course. I was on dialysis for nine months. My legs don't bend, my hands don't bend like they used to," explains Priester.
more

Victims of the vaccine?

2004-11-06T04:46:00.001-08:00

Two days after a military nurse injected Lavester Brown with the anthrax vaccine at Pope Air Force Base near Fayetteville, his heart failed.
Brown was 34, an avid athlete, career military. Doctors had warned him to avoid vaccinations, he said, because of a reaction to a malaria drug in the early '90s. But when Brown told superiors, he said, they warned he could be kicked out of the military if he didn't get vaccinated for anthrax.
Brown was afraid: of the vaccine, of losing his job. He had a wife and four young children to support.
"I kept telling them, `I can't take the shot.' "
The vaccination is mandatory, part of the military's war on terrorism. Brown had been in the Air Force 14 years and was trained to follow orders. So when a commander, a major, a captain and a first sergeant all ordered him to be vaccinated, Brown, a technical sergeant, rolled up his sleeve and took the jab.
He is now awaiting a heart transplant.
Thousands of soldiers have suffered unexplained illnesses after getting the anthrax vaccine, ranging from muscle aches to death. The federal Food and Drug Administration says the vaccine has no more side effects than other vaccines, but cases like Lavester Brown's raise troubling questions:
Is the vaccination safe?
Should the military require troops to take it?
There was concern about the anthrax vaccine long before the threat of global terrorism.
In the 1990s, the FDA found problems with quality control procedures at the only U.S. company that makes the vaccine, then owned by the state of Michigan. The FDA warned that if the problems were not corrected, the company could lose its license. The state halted production in 1998 and began renovations, then sold the plant to BioPort.
After terrorists hijacked planes on Sept. 11, 2001, and anthrax-laced letters killed five people and infected at least 13 others, demand for a vaccine erupted. In January 2002, the FDA gave BioPort approval to distribute its vaccine to the military.
The FDA and the Department of Defense and BioPort all say the vaccine is safe. A vocal group of current and former military personnel, doctors and members of Congress claims it is not. Three lawsuits challenging the vaccine are now in federal court.
To the emergency room
Brown knew nothing of the controversy on Friday, Feb. 27, when he got the fourth in a series of six anthrax shots.He rarely got sick, not even a cold. He didn't drink. He didn't smoke. He stood 5 feet 11 1/2 inches and weighed 207 pounds, but so much was muscle, he looked lean.
The day after the fourth anthrax shot, Saturday morning, he played basketball at the gym as usual but quickly tired. He went to the emergency room that night, he said, and a military doctor diagnosed a gastrointestinal infection.
By Sunday, he felt as if his body was filling up with fluid. The muscles in his neck throbbed and bulged. He had trouble breathing. Back at the emergency room that night, he said, a doctor again diagnosed gastrointestinal infection.
Something else is happening, Brown remembers saying. I can't breathe.
He said his wife, Ebony, insisted on X-rays. "When they looked at the X-rays," Brown recalled, "the doctor got this look on his face. I knew something was terribly wrong."
Brown said his heart was so enlarged, it had almost stopped pumping. He now takes medication to keep it beating until a transplant becomes available. He has dropped to 151 pounds, and walking only a few feet exhausts him. Friday, he was medically retired from the Air Force.
Before he got sick, Brown sometimes worked two jobs to provide for Ebony and their four children, ages 5 to 12. Now Ebony works and the children help care for him, and that's been a tough transition.
"I wish we had done our homework before Lavester got in line (for the vaccine)," Ebony said. "We trusted the military."
Mandatory shots
Until recently, anthrax had been considered primarily a livestock disease. People can be infected in three ways -- through skin contact, by eating infected meat or by breathing airborne spores -- but it's rare.
The military became convinced that Iraq had developed biological weapons, including anthrax, and might pack its Scud missiles with the deadly bacteria. Nearly everyone who inhales anthrax dies if not treated.
In 1998, the Defense Department made vaccinations mandatory.
Since then, about 1.2 million military personnel have received the vaccine, six doses over 18 months, followed by yearly boosters. (Several hundred thousand, a Pentagon spokesman said, got the vaccine during the 1991 Persian Gulf War.)
Out of 4.7 million doses given since 1998, the government says it has received 3,817 reports of adverse reactions, from headache, fatigue and fever to cancer, cardiac arrest and autoimmune diseases. The reaction rate, the government says, is about the same as for other adult vaccinations.
Studies have reached conflicting conclusions.
The Pentagon cites a 2002 report by the Institute of Medicine, a private, nonprofit scientific group, that said a better vaccine is needed, but that the current vaccine is "acceptably safe and effective."
Other studies link the anthrax vaccine to Gulf War illness, a medically unexplained fatigue suffered by veterans of the first Gulf War. One study found more adverse reactions to the anthrax vaccine than to other vaccines, and urged doctors to report all reactions so the scope of the problem could be determined.
Many cases, critics say, still go unreported.
Dead at 29
Christine Nilson, who lives in Wilmington, hadn't heard about the controversy over the anthrax vaccine until after her husband, Erik, died.Now she's convinced it killed him.
Erik Nilson flew CH-46 helicopters for the Marine Corps and was vaccinated twice, before two separate six-month deployments to the Mediterranean.
Soon after he came home for the second time, in October 2001, Christine noticed the whites of his eyes had yellowed. Doctors at Walter Reed Army Medical Center in Washington discovered bile duct cancer, a slow-moving, usually fatal cancer that most often attacks people over 60.
Nilson was 29 and had a 2-year-old son, Luke.
He was, Christine said, "a man's man," who loved hunting, fishing and the Marines. He had had a rough childhood, she said, and often told her he wanted nothing more than to be a good father.
Six months after the cancer was discovered, Erik Nilson died.
Christine Nilson said no one from the military ever mentioned a possible connection with the anthrax vaccine. The national Vaccine Adverse Events Reporting System has no record of Nilson's death.
But the more Christine Nilson read, the more she believed there was a connection.
"There is," she said, "no other explanation for it."
Rapid-acting diseases
Other service members have died of rapid-acting diseases after getting the vaccine, including Army cook Sandra Larson of Kansas. Four weeks after her sixth anthrax shot, she was diagnosed with aplastic anemia, a rare disorder resulting from failure of bone marrow to produce blood cells.
She died two months later. She was 32.
The package insert on the vaccine, approved by the FDA in 2002, cites her death and the deaths of five other vaccinated military members. But a panel of civilian doctors concluded that none of the deaths was related to the vaccine.
The Pentagon has linked only one death to the vaccine: Rachel Lacy, a 22-year-old Army reservist, who died in April 2003 of a pneumonia-like illness after receiving five vaccines, including anthrax. The Pentagon said the vaccines may have triggered the illness that led to her death, but that "the evidence was not conclusive."
Critics say the government is stonewalling the way it did with the herbicide Agent Orange in the Vietnam War and with Gulf War illness.
"The first thing they do is fight, deny, obfuscate ...," said Steve Robinson, executive director of the National Gulf War Resource Center, an advocacy group for veterans. "Meanwhile people are getting sick."
About 10,000 Vietnam veterans receive disability benefits because of exposure to Agent Orange, and tens of thousands of others suffer illnesses. An estimated 100,000 Gulf War veterans suffer a range of symptoms, including memory and thinking problems, fatigue, joint pain, depression, anxiety, insomnia, headaches and rashes.
No proof, no medical help
Robinson said he has spoken with hundreds of veterans who said they had adverse reactions to the anthrax vaccine, but they can't prove it and are not getting the medical help they need. They complain of chronic fatigue, bone and muscle pain, migraine headaches, short-term memory loss and cognitive impairment."While anthrax is a threat," Robinson said, "the American public, much less the military, should not be given an inferior vaccine."
Meryl Nass, an internist in Bar Harbor, Maine, who has testified before Congress about the vaccine, said she has treated dozens of soldiers and corresponded with thousands more.
"I've seen so many people with the exact same thing, the same story," she said. "They can't think straight. They have pain in different parts of their bodies ... and they're fatigued." Usually, she said, they have something else wrong, too: multiple sclerosis or lupus or a sleep disorder.
As a doctor, Nass said, the last few years have been an emotional roller coaster "watching 1 million be vaccinated when I knew at 100,000 what was happening."
Forced vaccinations
In federal court, two lawsuits are pending against BioPort, a third against the Food and Drug Administration, the Defense Department and the Department of Health and Human Services.
The lawsuits challenge whether the vaccine is safe, effective, even necessary.
On Dec. 22, 2003, U.S. District Judge Emmet Sullivan in Washington, D.C., blocked the Pentagon from forcing soldiers to get vaccinated. He ruled that the FDA had never approved the vaccine for use against inhaled anthrax. The military, he said, could not make troops "serve as guinea pigs for experimental drugs."
Eight days later, the FDA approved the vaccine against inhaled anthrax.
Although Sullivan called the timing of the order "highly suspicious," he lifted his injunction.
The military once again ordered vaccination.
Refusal, court-martial
As many as 500 active-duty personnel have been dismissed from the military for refusing vaccination, according to congressional testimony. At least 100 have been court-martialed.Tom Kaufmann, an airman first class at Seymour Johnson Air Force Base in Goldsboro, refused to be vaccinated in December 2002.
He had read about problems at the manufacturing plant, he said, as well as about illnesses among people who got the vaccine.
Kaufmann, now 22, was demoted, then discharged under "conditions other than honorable."
"My first sergeant repeatedly called me a coward, saying I was afraid of war, afraid of serving my country," Kaufmann recalled. "I told them that I wanted to deploy. I wasn't against the war."
He was, he said, only against the vaccine.
â?¢ Anthrax comes from the Greek word for "coal" because infected skin forms ugly black lesions.
â?¢ The rod-like bacteria were discovered in the 19th century. Louis Pasteur created the first vaccine in 1881.
â?¢ Anthrax spores can live in soil for decades. People contract the disease in three ways: through skin contact, eating infected meat or breathing airborne spores.
Most Common Adverse Reactions
erythema, headache, arthralgia, fatigue, fever, peripheral swelling, pruritus, nausea, injection site edema, pain/tenderness and dizziness.
Less Frequent Adverse Reactions
cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-BarrÃ© syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system.
Fatalities
cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system lymphoma (1)
SOURCE: FDA-approved package insert for anthrax vaccine
Elizabeth Leland: (704) 358-5074; eleland@charlotteobserver.com.

The "New" Anthrax Vaccine

2004-11-05T14:13:00.000-08:00

The following info is from Mr. Matsumoto, look to his book Vaccine A for more info on this click here more

"Based on the most recent run of Tulane's assay, other than the six lots of vaccine already proven to contain squalene (FAV 008, FAV 020, FAV 030, FAV 038, FAV 043, FAV 047), only two lots are definitively linked to the induction of anti-squalene antibodies (FAV 070 and FAV 071). However, an additional seven vaccine lots (FAV 048b, FAV 066, FAV 068, FAV 069, FAV 073, FAV 074, FAV 075) are causing the same autoimmune pathology in patients who received vaccinations from lots confirmed to contain squalene. The first batch of recombinant protective antigen protein, which is the chief pharmaceutical ingredient in the Army's second generation anthrax vaccine, rPA102, was made in a National Cancer Institute lab at Fort Detrick. Other laboratories that had a hand in the developing rPA102 were the Salk Institute, Battelle Memorial Institute, DynPort and Science Applications International Corporation (SAIC)."

This is important...

2004-11-04T22:24:00.000-08:00

Just a few brief facts, which follow this paragraph, are enough to raise most people's eyebrows. You can also scroll down below this section for advice on what to do if you are facing deployment and are being ordered to take the vaccine, a chronology documenting the history of this vaccine, adverse reactions troops and veterans have reported, a full symptoms list taken from VAERS reports and medical reports, and more resources.1. The anthrax vaccine was never licensed for use against aerosolized anthrax until, mysteriously, the FDA suddenly sprang into action last month (Dec. 2003) after Judge Emmet Sullivan's decision that use of the vaccine is illegal - a decision still pending. Now, the FDA and the Dept. of Defense are claiming that it's all right to use animal data to license the vaccine. Prior to 2002 animal data was not allowed for full licensure of drugs. DoD and FDA co-sponsored this change to the law when they were caught using the anthrax vaccine experimentally for inhaled anthrax. So the lawbreakers are the ones who have changed the law to fit their circumstances, and now claim to be using this changed law to suit their purposes2. Despite 18 years of elapsed time and a Citizen Petition calling for finalizing the rule of the anthrax vaccine as an Investigational New Drug, this was also never done until late in Dec., 2003, in response to Judge Sullivan's ruling. Meantime, troops were ordered to take this experimental vaccine against their wishes - without either informed consent or a presidential waiver as is required by law.3. The anthrax vaccine was originally licensed based on data from a different vaccine. The only safety/efficacy study ever done on human beings was done on that different vaccine. The FDA and DoD have also previously admitted that efficacy, based on animal studies, against inhalation is problematic because no proven correlate of immunity between animals and humans exists for anthrax infection.4. The anthrax vaccine protocol originally called for 3 shots only; the change to a series of 6 shots with annual boosters was done with no foundation in research or fact. The label was actually changed to reflect the protocol then in practice; the protocol was not dictated by instructions on the label (see chronology of the anthrax vaccine - link on this page)5. BioPort, the original manufacturer of the vaccine, changed its filtering and fermenting equipment in 1991 without notifying the FDA. The result was a 100-fold increase in the potency of the vaccine. It was used anyway.
BioPort also produced non-sterile and contaminated vaccine before the FDA shut it down for 4 years. It was used anyway.
BioPort's punishment? A brand new contract with the government (see news archives) since the DoD is so certain Judge Sullivan's ruling will be overthrown.
A red flag at BioPort, and at many pharmaceutical companies, is the presence on their boards of retired military personnel. In BioPort's case, former Chairman of the Joint Chiefs of Staff, Admiral William Crowe, has long been a player.
6.The Kansas State University Study (see the Gulf War Syndrome page on this site) has definitely pointed to the anthrax vaccine as one of the major components of Gulf War Syndrome.

U.S. to Buy 75M Doses of Anthrax Vaccine

2004-11-04T21:45:00.000-08:00

A new company has been authorized to create a vaccine what is in this one?

By DIEDTRA HENDERSON, AP Science Writer

WASHINGTON - The government said Thursday it is purchasing 75 million doses of a new generation anthrax vaccine under an $877.5 million contract — the first awarded through a federal program to develop and stockpile antidotes to biological and chemical weapons. more

Daily Hero

2004-11-03T19:17:00.000-08:00

Petty Officer Third Class David M. Ponder
(as of Jan. 2001)
David M. Ponder is currently serving time in Pensacola for refusing to take the anthrax vaccine. Ponder was sentenced last week to 60 days and a two-grade, pay-and-rank cut. more

Vance Wasden
Vance Wasden was medically discharged from the Air Force nearly two years after becoming extremely ill upon taking the anthrax vaccine, lot #020. His 23 different conditions have left him, as a young man, walking with a cane. Vance and his wife, Michelle, have traded roles as have many couples where the primary breadwinner has become ill from the vaccine. Vance stays home with the couple's four children, while Michelle holds down a full-time job. They have received VA disability benefits after fighting for them for years.more

Captain Jason M. Nietupski
The following letter requesting help is a comprehensive overview of Jason Nietupski's reactions to the anthrax vaccine and his subsequent search for help. Following this later are two updates on the outcome of his case. April 16, 2001 To Whom It May Concern: My name is Captain Jason M. Nietupski from the 104th Fighter Wing, Massachusetts Air National Guard. I am writing this letter to the Institute of Medicine to explain, for the record, my adverse reactions to the anthrax vaccine, which was directed by the Department of Defense's (DoD) Anthrax Vaccine Immunization Program (AVIP). I have served in the US Armed Forces for nearly 6-years with a distinguished military record as both an Active Duty and Reserve officer. In April 2000, I was a member of the 8th US Army, US Army Reserves in Farmington, Michigan when I was deployed to South Korea for a 2-week military exercise. More

Grant provides $3.5 million for anthrax vaccine study in Seattle

2004-11-02T17:37:00.000-08:00

November 2, 2004, 6:01 AM
SEATTLE (AP) -- A research team has been awarded a $3.5 million federal grant to use a molecular detective technique to study and potentially improve the military's anthrax vaccine.
Anthrax bacteria can be used as a bioterrorism or germ warfare agent.
Lansing, Mich.-based BioPort Corp. has a $245 million contract with the Pentagon to supply the military with anthrax vaccine. On Oct. 27, a federal judge ordered a halt to the mandatory anthrax vaccination program for U.S. military personnel.
Bioport uses the decades-old technique of filtering killed bacteria. It is administered in six injections over 18 months and must be repeated regularly to maintain immunity.
The grant to the Benaroya Research Institute was one of 14 announced Monday in a $74 million program by the National Institute of Allergy and Infectious Diseases to develop better vaccines or medications for use against infectious agents.
The team headed by Dr. Gerald T. Nepom, director of the private, nonprofit institute at Virginia Mason Hospital, has developed artificial molecules called "tetramers" for the anthrax vaccine research.
Service personnel sued the Defense Department, arguing that the vaccine was rushed through approval before the Iraq war and saying evidence indicates it has caused immune illnesses in a significant number of soldiers.
Defense Secretary Donald H. Rumsfeld has maintained that the "vaccine is safe and effective," but many scientists view it as crude and cumbersome to administer.
Nepom and Dr. William W. Kwok, principal investigator on the Benaroya project, say their engineered molecule provides a streamlined, more accurate test that could soon point the way to a better vaccine.

Hero punished for criticizing vaccine

2004-10-31T20:17:00.000-08:00

Recent case of unfair treatment.

Special operations sergeant reprimanded for going to surgeon at DAFB
By LEE WILLIAMS / The News Journal
10/31/2004DOVER -- Jason Adkins is a hero.

On May 13, 2003, the technical sergeant was on the first C-5 flown into Baghdad. The aircraft and the runway were blacked-out. Adkins, the pilots and the crew wore night-vision goggles, casting a green tint on the gunfire that filled the skyline.

His next mission was even worse.

On Jan. 8, 2004, after another C-5 had an engine shredded by a surface-to-air missile, Adkins was picked to help fly the crippled aircraft out of Baghdad on its three remaining engines - a bold feat even airworthiness experts didn't know was possible with a 374,000-pound aircraft.

"We knew if [the plane] took another missile, we'd be riding it into the dirt," he said.

C-5s don't have ejection systems or parachutes for pilots or crew.

Adkins and the entire crew were recommended, and are still in line, for the Distinguished Flying Cross, one of the nation's highest awards for bravery.

Now, despite medals, special operations missions and an unblemished service record spanning 14 years, Adkins says commanders at Dover are making an example of him because he complained about his medical issues linked to the anthrax vaccine. Adkins believes he's being punished to send a warning to other personnel that they shouldn't call attention to the most controversial issue to hit the base since the Vietnam War.

Adkins' former commander, retired Col. Felix Grieder, is enraged that an airman of Adkins' abilities is being singled out for speaking the truth.

Letter Sent to Rumsfeld

2004-10-30T19:07:00.000-07:00

The following letter was sent to Rumsfeld by three Senators as of yet there has been no answer. Please comment so that I can show that we want to know.

October 13, 2004

The Honorable Donald Rumsfeld
Secretary of Defense
1000 Defense
The Pentagon
Washington, DC 20301-1000

Dear Secretary Rumsfeld:

We write regarding concerns raised in recent press reports about the military's anthrax vaccination program at Dover Air Force Base. Former Dover AFB Commander, Colonel Felix Grieder, has alleged that his troops were subjected to human tests involving the use of the adjuvant squalene in the anthrax vaccine. We request the Department conduct a thorough investigation of the presence of squalene in the anthrax vaccine used at Dover AFB from the inception of this vaccination program to current useage. Furthermore, we request that the Department immediately provide us with written assurance that all vaccinations currently being performed at Dover AFB do not contain the adjuvant squalene.

The importance of clearing the air on this issue cannot be overstated. It is in the best interests of everyone for there to be well-documented and readily available information regarding the necessity of the anthrax vaccine, the presence or absence of squalene, and the possible health effects associated with the vaccine and given amounts of squalene. It is critical to the credibility of the U.S. Air Force that the concerns raised by a former wing commander be reviewed in an open and transparent fashion. The controversy surrounding the history of the anthrax vaccine at Dover AFB creates a drag on morale and concerns among personnel at a time when all of their energy should be devoted to their vital missions.

As part of resolving this issue, we would like to know the results of the research we understand the Department has done on the effects of squalene in vaccines. In addition, it is important to explain the rationale for the Army’s decision to seek a patent for a new anthrax vaccine that includes squalene. What is the status of that vaccine’s development and testing? In the case of squalene, what is the scientific basis being used by the military for deciding that there are no harmful effects resulting from the introduction of a foreign element into the human body, even if that element is already present in the body?

It is critical that the Department provide more specific, comprehensive, and scientifically defensible answers that explain what happened at Dover AFB, what the Department is doing to ensure that there is not a repeat of these problems, and how the Department is ensuring accountability. At a minimum, a great deal of unnecessary confusion and anxiety has been caused by the handling of this issue. At a maximum, intentional actions or unintentional incompetence may have created a health hazard for our personnel. In light of the fact that the mandatory anthrax vaccination program is being restarted and expanded, we believe it essential that you address the questions and concerns raised in these reports as quickly as possible.

Again, we request that the Department undertake a complete investigation and provide us with a detailed report by November 15, 2004. We look forward to your answers to these questions and to working with you to ensure the safety of our military personnel. For your information we have attached copies of the recent relevant press stories.

Sincerely,

Joseph R. Biden, Jr. Thomas R. Carper Michael N. Castle
United States Senator United States Senator Member of Congress

U.S. Barred From Forcing Troops to Get Anthrax Shots

2004-10-28T20:01:00.003-07:00

You will notice in this article that there is no mention as to why it(vaccine) may be harmful!

By Marc Kaufman
Washington Post Staff Writer
Thursday, October 28, 2004; Page A01

The Defense Department must immediately stop inoculating troops with anthrax vaccine, a federal judge ruled yesterday, saying that the Food and Drug Administration acted improperly when it approved the experimental injections for general use.

Concluding that the FDA violated its own rules by approving the vaccine late last year, U.S. District Judge Emmet G. Sullivan said the mandatory vaccination program -- which has inoculated more than 1.2 million troops since 1998 -- is "illegal."

Sullivan said that his ban on involuntary vaccination will remain in place until the FDA reviews the anthrax vaccine properly or until President Bush determines that the normal process must be waived because of emergency circumstances.

The Defense Department has required many troops serving in Iraq and Afghanistan to be vaccinated, and it has punished and sometimes court-martialed those who refused. The Pentagon expanded its anthrax and smallpox vaccination programs in July to include troops stationed in South Korea and other areas in Asia and Africa, despite complaints from some service members that the anthrax vaccine made them sick.

In a statement, the Defense Department said it is reviewing the decision and will "pause giving anthrax vaccinations until the legal situation is clarified. . . . DoD remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe and effective."

In his ruling, Sullivan said that the FDA's approval was invalid because it did not meet the required review standards and the agency failed to seek the necessary public comment.

"Congress has prohibited the administration of investigational drugs to service members without their consent," Sullivan said. "This Court will not permit the government to circumvent this requirement."

"The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all -- public scrutiny. This is the process the FDA in its expert judgment has outlined, and this is the course this court shall compel FDA to follow," Sullivan wrote.

The judge ruled on a suit filed in March 2003 by six service members and civilians who argued that the FDA never properly reviewed the vaccine's ability to protect against inhalation anthrax. The suit contended that the drug was never shown to be effective, and that some vaccinated troops experienced extreme fatigue, joint pain and temporary memory loss after being vaccinated. The vaccine, made by BioPort Corp. of Lansing, Mich., is given in a series of shots.

Mark Zaid, an attorney for the six who has also defended more than a dozen service members court-martialed for refusing the vaccination, said one of his clients is a breast-feeding mother who does not think the vaccine is safe for her child.

"We will now initiate an effort to ensure the government reverses all punishments that were imposed for refusing an order to take the vaccine," Zaid said. He said he will also seek compensation for service members who contend they were harmed. "As we've seen in Iraq, there wasn't any actual threat from anthrax, so there was never any real need for the vaccine," Zaid said.

Sullivan initially ruled in late 2003 that the FDA had never approved the vaccine and ordered that the inoculations be stopped. Eight days later, the FDA approved the vaccine based on an application made 18 years earlier, and the inoculation program was resumed. Yesterday's ruling concluded that the agency did not follow its own rules in declaring the vaccine safe and effective.

In particular, Sullivan criticized the FDA for not allowing the public to comment on its decision -- a prerequisite for any approval. There was some public comment when the approval was first sought in 1986, but the 2003 decision was based on research conducted later and never subjected to public comment.

The FDA argued that comments had been submitted as part of a 2001 citizens' petition questioning proposals to begin the vaccinations, but Sullivan found them insufficient. "It is clear to this Court that if the status of the anthrax vaccine were open for public comment today, the agency would receive a deluge of comments and analysis that might inform an open-minded agency," he wrote.

Because the anthrax agent is so deadly, it has been difficult to test a vaccine that might protect against it. The best data have come from a study in the 1950s of workers at a factory that processed animal hides and furs, which can transmit naturally occurring anthrax. That study found that the vaccine now used by the military was effective in reducing the incidence of anthrax spread by contact, but the research involved only a tiny sample of people who might have inhaled the bacteria.

Anthrax vaccine was used in a limited way in the 1991 Persian Gulf War. A more expansive effort began in 1998. Difficulties in manufacturing the vaccine stopped the program in 2000 and 2001, but the vaccination effort was resumed and greatly expanded in 2002.

Staff writer Bradley Graham and researcher Madonna Lebling contributed to this report.

Test that can help detect squalene

2004-10-28T07:25:00.000-07:00

Vaccine A

If you are looking to see what tests are available here is a list you can ask your doctor to take.

The tests which are of help with adjuvant-induced autoimmune problems include:
ANA, rheumatoid factor, ESR, CRP, CPK, ANCA, antiphospholipid antibodies, antithyroid microsomal antibodies, antineuronal antibodies, CBC with diff., SMA-20, thyroid profile with TSH, complement C3 and C4.

I was urged to state that they may not be positive at first but if you feel symptoms it can be possible. I am not trying to creat hysteria I am looking to help others who have been mistreated by the country we protect.

Important links

2004-10-26T10:08:00.000-07:00

Vaccine A Official Book site
Returning Veterans Assistance
The perilous experiment
Squalene info
The Ground Truth: The Human Cost of War
Operation Truth
National Gulf War Resource Center, Inc.

Trying to give notice

2004-10-26T08:23:00.000-07:00

This is a copy of what I have sent news agencies in the area.

Dear Sir or Ma'am,

There have been recent developments on the anthrax vaccine program. I am a veteran Iraqi Freedom and I personally have began having a few problems. As of today the pentagon has begun revaccination. Please see this link http://vaccinea.blogspot.com/.

I have more info on this please contact me if you want to know more.

j blaze

Pentagon Resumes Anthrax vaccinations

2004-10-26T08:05:00.000-07:00

By Sandra Jontz,
Stars and Stripes European Edition

ARLINGTON, Va. — Troops who received some of their anthrax inoculations before the Pentagon halted it 3 years ago have until Dec. 31 to resume their six-shot regimen, no matter where they might be stationed, officials said.

About 200,000 troops need to pick up the vaccination where they left off, even if it has been three years since their last shot, said Col. Steve Jones, director of the Military Vaccine Agency.

Commanders will be responsible for working with health care providers and troops to ensure shot records are up-to-date and that those who qualify get their shots, Jones said.

The controversial vaccination program is mandatory for all personnel deploying to areas Pentagon officials have deemed “high risk,” and for those who already started the process. The department will not inoculate those exempt for health reasons, though exempted personnel still are deployable.

For security reasons, Pentagon officials won’t publicly define the high-risk areas, or say how many doses are available.

Anthrax vaccines were suspended in June 2001 because of a lack of vaccine when the manufacturer, BioPort, changed its manufacturing process without FDA approval. The stoppage created a stockpile shortage for the military. When the program resumed in 2002, it first started with troops deploying to the high-risk areas. With supply no longer an issue, the program can expand to include other troops, Jones said.

Some servicemembers have maintained the vaccine causes health problems and have accepted separation from service or disciplinary action for disobeying an order rather than take it

This summer, the Pentagon expanded the vaccination program in two phases. In June, as a result of an increase in supply, the Pentagon started inoculating “tens of thousands” of U.S. troops in or heading to the Pacific Command and Central Command areas.

In July, the program resumed for troops who already had received a dose before the program’s halt, regardless if deployed to a combat zone or stationed in the United States, Jones said.

Stars and Stripes requested information from the Department of Defense after seeing reports on the matter.

Since the June 2002 resumption, the department has inoculated about 840,000 personnel. Since the program’s inception in 1998, more than 1.2 million people have been vaccinated, he said.

In spite of the lag, troops do not have to start over with the regimen, experts said.

“We’re following guidance from the CDC (Centers for Disease Control and Prevention) … on immunization practices and they recommend to one, stay on schedule as close as possible, and two, if you miss [a dose] it is not necessary to resume the entire sequence. Start where you left off,” Jones said.

However, the shots are unnecessary, said Dr. Meryl Nass, a physician at Mount Desert Island Hospital in Bar Harbor, Maine, and an anthrax and bioterrorism expert who has testified repeatedly before Congress as a vocal opponent to the program.

“What is the evidence that there is a risk? There is none,” said Nass. “[Presidential candidates] Bush and Kerry both are beating the drums about the risk of bioterrorism, but every credible organization that has looked into the issue hasn’t found any,” she said. “There are no weapons of mass destruction [in Iraq] and two groups hand-picked to find them didn’t find them.”

But troops need the vaccine, Jones said.

“We still feel the threat remains,” Jones said. “We do not see a change in the threat and we think it is important to continue to provide a layer of protection to our troops and vaccinations is one of the primary layers of protection we can provide them.”

The CDC is conducting studies to determine if the six-dose regimen can be lowered to four. It hopes to submit data to the FDA in early 2005 that could change the route of administration to intramuscular and reduce the dose schedule to five doses, with the full study to change to four doses and possibly biannual boosters in late 2007.

Squalene

2004-10-25T18:36:00.000-07:00

Squalene
Vaccine ingredients

"Our results strongly suggest that the production of anti-squalene antibodies is linked to symptoms of Gulf War illness and to the presence of squalene found in certain lots of anthrax vaccine.....human exposure to squalene in vaccines has been shown by others to cause immunological symptoms similar to those found in Gulf War illness patients. ......The absence of an association between the presence of Gulf War illness and deployment indicates that the causative agent or factor is not associated with the Persian Gulf. Consistent with this observation are the results of a recent epidemiological study finding that vaccinations that were given to both deployed and non-deployed personnel are associated with ill health. .......The presence of anti-squalene antibodies in ill people and the absence of the antibodies in healthy people is the first hard laboratory evidence that Gulf War illness is what some might refer to as a "real disease." ----Dr. Robert Garry

[Media Oct 2004] Castle insists on response from military, Pentagon asserts vaccine program safe to continue

ANTI-SQUALENE ANTIBODIES LINK GULF WAR SYNDROME TO ANTHRAX VACCINE

Dr. Robert Garry Testimony, The House Subcommittee on National Security, Veterans Affairs, and International Relations

[Media July 2001] Illegal vaccine link to Gulf war syndrome

Breakthrough on Gulf War Illness By Paul M. Rodriguez

Gulf War Illness Update By Paul M. Rodriguez

Gulf War Mystery and HIV By Paul M. Rodriguez

The Gulf War Mystery By Paul M. Rodriguez

Holmdahl R, Lorentzen JC, Lu S, Olofsson P, Wester L, Holmberg J, Pettersson U. Arthritis induced in rats with nonimmunogenic adjuvants as models for rheumatoid arthritis. Immunol Rev. 2001 Dec;184:184-202. PMID: 12086312 [PubMed - in process]
Rat models are useful for studies of the pathogenesis of rheumatoid arthritis (RA) since rats are extraordinarily sensitive to induction of arthritis with adjuvants. Injection of not only the classical complete Freund's adjuvant but also mineral oil without mycobacteria and pure adjuvants such as pristane and squalene, induce severe arthritis in many rat strains. Models like pristane-induced arthritis in rats are optimal models for RA since they fulfill the RA criteria including a chronic relapsing disease course. Arthritogenic adjuvants like pristane, avridine, squalene and mineral oil are not immunogenic since they do not contain major histocompatibility complex (MHC) binding peptides. Nevertheless, the diseases are MHC-associated and dependent on the activation of alphabetaTCR (T-cell receptor)-expressing T cells. However, it has not been possible to link the immune response to joint antigens or other endogenous components although immunization with various cartilage proteins induce arthritis but with different pathogeneses. To unravel the mechanisms behind adjuvant-induced arthritis, a disease-oriented genetic approach is optimal. Several loci that control onset of arthritis, severity and chronicity of the disease have been identified in genetic crosses and most of these have been confirmed in congenic strains. In addition, many of these loci are found in other autoimmune models in the rat as well as associated with arthritis in mice and humans.

[Home]

2004-10-25T18:13:00.000-07:00

to see more of book

2004-10-25T18:06:00.000-07:00

» Introduction
The Greatest Story Never Told
For the past 17 years, the Army has been working on a new anthrax vaccine that contains no anthrax, and is made with an ingredient that it does not want to name. That ingredient is called squalene. Squalene is an oil. Without it, the new vaccine will not work any better than the old one. In fact, for all intents and purposes, without squalene the new vaccine is the old one. What makes squalene so important is its proven ability to stimulate a strong response from the immune system. That is something the main ingredient of the new vaccine, the now ultra-purified protein secreted by the anthrax microbe—recombinant protective antigen—cannot do by itself. It is too weak.
Immunologists have a special name for substances used to boost feeble vaccines. They are called adjuvants. Adjuvants are arguably the most extensively researched pharmaceutical product in the last quarter century that you never heard of. I have used the word adjuvant three times in this paragraph so far and that is probably three times more than you have ever seen it in print before. This is partly because the most effective adjuvants, those formulated with oils, are too dangerous for human use. That is squalene's other proven ability, causing incurable disease, which is why it is such a touchy subject with the Department of Defense.
The word adjuvant comes from a Latin word that means "to help." But with oil adjuvants like squalene that term is misleading. Today, only one adjuvant—an aluminum salt called alum—is licensed for human use. All the oil adjuvants are so noxious that their use is restricted to experiments with animals, and even then, governments have written strict regulations to govern how they are used. The classic oil adjuvant, called Freund's Complete Adjuvant, is considered too inhumane to even inject into animals. It does a terrific job of stimulating the immune system, though. Unfortunately, Freund's Complete Adjuvant can cause permanent organ damage and incurable disease. As early as the 1930s, these oil additives were notorious for inducing illness. By the 1950s, scientists knew these illnesses were specifically autoimmune. Today that is their chief use in research—inducing disease instead of preventing it. Scientists studying autoimmune disease cannot wait around for its spontaneous appearance in a lab animal; they inject it with Freund's Complete Adjuvant to reproduce autoimmunity on demand. Oil adjuvants made with squalene equally effective at this job, and regrettably according to Dutch scientists, equally inhumane. , ,
Autoimmune diseases are chronic and progressively debilitating ailments; some, like multiple sclerosis and lupus, can be fatal. They occur when the immune system loses its ability to distinguish what is "self" from what is foreign. Under normal circumstances, your immune system ignores the constituents of your own body; immunologists call this "tolerance." But if tolerance is broken, the immune system turns relentlessly self-destructive, attacking the body it is supposed to defend.
Adjuvants can break tolerance. In 1956, Dr. Jules Freund, the Hungarian born scientist who gave his name to the adjuvant he created, warned that animals injected with Freund's developed terrible conditions: allergic aspermatogenesis (stoppage of sperm production), experimental allergic encephalomyelitis (the animal version of multiple sclerosis) and allergic neuritis (inflammation of nerves that can lead to paralysis), allergic uveitis (an inflammation in the eye that can cause blindness). There was no reversing any of these conditions.
Scientists are still unsure why oil adjuvants do this. One theory is that oils have the ability to hyperactivate the immune system. "The cause is probably that when injecting these molecules, you create a chaos in the immune system," says Dr. Johnny C. Lorentzen, and immunologist with the Karolinska Institute, which awards the annual Nobel Prize for Medicine. He says these oils induce "an extremely powerful response," so powerful, in fact, that the immune system goes haywire and starts attacking things it would otherwise leave alone. Another possibility, which has not been explored very much, is that this harmful phenomenon actually has something to do with one of the greatest distinguishing characteristics of the immune system—its specificity. Over eons in time, this extraordinarily elegant and powerful system has evolved to respond very precisely to what it deems potentially harmful to the body. Our bodies contain all sorts of oily molecules. It could be that when an oil is injected, the immune system actually responds to it with a high degree of precision - just as it responds to everything else - but because the adjuvant resembles too closely those oils found in the body, the immune system begins attacking those too. In immunology this is called a "cross reaction." Neither proposition - chaos or specificity - has been proven so far. But however oils do their damage, it is well known that they do.
Army scientists have been as aware as anyone else of the harm that injecting oils can do. The problem for military personnel is that these scientists learned this lesson by injecting oils into troops in experiments that in some cases they did not agree to participate in. The central question in this book is whether such an experiment has been done again with the new anthrax vaccine and squalene.
Round One
Despite their dangers, oil adjuvants have come to exert an irresistible, almost magical allure on researchers. If they could truly stimulate the immune system safely, oil additives could help defend mankind from diseases like malaria and HIV. For germs such as these, no one dared make a classic vaccine - the kind made from the germ itself - for fear of accidentally infecting someone with an incurable, if not fatal infection. By splicing off just little bit of such a germ - not enough to make anyone sick - and combining that shard with an adjuvant, scientists hoped to protect people from lethal microbes. If they could do it for HIV, they reasoned, they could do it for any germ in creation. This siren song was so powerful that it did more than induce researchers to indulge in cynical risk/benefit calculations; in some cases, it made them forget the risks altogether.
The first time Army scientists succumbed to this allure was in 1951 at Fort Dix, New Jersey in an experiment that involved 44,459 troops. More than 18,000 of them got injected without their informed consent with a newly formulated oil additive for vaccines. The Army thought it had something new and safe. The world's best additive that no one dared inject into humans, Freund's Complete Adjuvant, was more than just mineral oil. It also contained Mycobacterium tuberculosis, the germ that caused TB. The mycobacteria were dead, but scientists thought they still might be in some way responsible for the problems associated with this concoction. So they removed the mycobacteria in hopes that the oil alone could do the trick; they called this new adjuvant "Freund's Incomplete Adjuvant." The incomplete adjuvant was just mineral oil in water, and a detergent to keep the oil evenly dispersed. Using it was a risky thing to do, but the Army considered the risks of not running this experiment even higher. This "incomplete" additive had been incorporated into an experimental flu vaccine. It was the flu that really worried the Army.
By all accounts, the great Spanish Flu pandemic of 1918 wasn't really Spanish at all. It was American. In fact, it was an Army flu. The first victim, the "index patient," was an Army private named Albert Gitchell who worked as a cook at the Army's Camp Funston on the vast Fort Riley military reservation in Kansas. It is believed that U.S. troops heading to Europe brought this flu with them. Before it was over, more than 20 people had died of influenza around the world—the deadliest natural disaster in world history. Army scientists wanted to prevent another global killer from emerging from an Army post where new recruits might become an unintended hatchery for some vicious new flu strain that once again could wipe out millions of people. Trying out a new oil additive on troops seemed like a relatively modest risk in comparison to the benefits of a better flu vaccine.
The Fort Dix experiment took place with the blessing of Fort Detrick. It was funded by the U.S. Army Medical Research and Development Command (USAMRDC), which would later oversee the development of the new anthrax vaccine and newer oil additives too. The Armed Forces Epidemiological Board (AFEB), which would be sponsor a large number of the experiments conducted on military personnel, would later recommend the injecting an experimental flu vaccine containing oil into every man and woman in the U.S. military without their informed consent. The risk of an outbreak of killer flu seemed too great to do otherwise. To run this experiment, the Army would contract none other than Jonas Salk. Salk had already tested Freund's Incomplete Adjuvant on medical students at the University of Pittsburgh under the sponsorship of the Armed Forces Epidemiological Board, and with funding from the Army Surgeon General. Based on this study, Salk thought it was safe.
Over the next two decades, the entire U.S. public health establishment - civilian and military - kept watch on what happened to the troops from Fort Dix. Everyone wanted in on the act. USAMRDC funded this study and its follow-ups. The National Academy of Sciences, the Walter Reed Army Institute of Research (WRAIR) and the Walter Reed Army Medical Center (WRAMC) did the initial round of surveys. Then the list started to grow. The National Academy of Sciences and the National Research Council organized more studies at the request of the Veteran's Administration, the Army and the U.S. Public Health Service "in collaboration with the Armed Forces Epidemiological Board." At the 17-year mark, academia got involved too. An AFEB scientist on the faculty of the University of Michigan School of Public Health organized yet another follow-up. No one, it seemed, wanted to be left out of such an important experiment.
And the experiment that seemingly had no end. Twenty-one years after Salk first injected unsuspecting soldiers with a theoretically new and improved flu vaccine, the Fort Dix troops were under the microscope yet again. The list of sponsors included many of America's most respected public health institutions: the National Academy of Sciences-National Research Council, the American Cancer Society, the Veterans Administration, the Department of Defense, the U.S. Public Health Service and the Commission on Influenza of the Armed forces Epidemiological Board. USAMRDC bankrolled this study, just as it did the first one. What was remarkable about this 21-year project - involving the military, civilian public health authorities and a major university - is that at no time during its execution did any of the scientists involved publicly discuss whether it was ethical to run a medical experiment on people without telling them. If these doctors had any concerns, they did not publish them.
Long before the last study was completed, AFEB proposed the adoption of an experimental flu vaccine with oil for everyone in the military. In 1963 and 1964, AFEB recommended injecting every man and woman in the armed forces with the new vaccine. The board also recommended that Department of Defense also commence studies with oil added to tetanus and diphtheria toxoids, and polio vaccines. , Army doctors seemed determined to add oil to every vaccine they could.
Here is what they were not telling anybody. By 1964, the year when everyone in the military was supposed to get immunized with an oil-boosted influenza vaccine, the Army already knew the risks this vaccine presented for a very specific type of illness. AFEB's Colonel Abram S. Benenson had drawn up a list of diseases that investigators should watch out for in veterans injected with the oily flu vaccine at Fort Dix. Benenson's list read like the contents of a chapter on autoimmune disease in an immunology textbook. It included multiple sclerosis, myelitis, Guillain-Barré syndrome, uveitis, neurodermatitis circumscripta and disseminata, amyloidosis, lupus erythematosus, dematomyositis, scleroderma, chronic pericarditis, Raynaud's disease, rheumatoid arthritis, rheumatoid myositis and acute glomerulonephritis—all of them autoimmune diseases.
The final study on the Fort Dix troopers had data that none of the previous ones had: autopsy results. The soldiers had grown older and many of them had died. Epidemiologists, mainly working for the National Research Council and the American Cancer Society, reported a "significant excess of deaths" in soldiers given the oil-boosted vaccine, which the investigators related to "ill-defined vascular lesions of the central nervous system." They attributed this fact to the greater number of autopsies available for the soldiers given the oil-boosted vaccine. But there were hints of a problem with autoimmunity. Ten percent of the soldiers studied, who were injected with the oil-boosted vaccine, developed a "collagen disease," which is a term doctors used to use interchangeably with autoimmune disease. Still, the number of patients in this study was too low to extrapolate any reliable conclusions from the data. That did not prevent government and military doctors from doing just that. They concluded that the oily flu vaccine was safe. Nevertheless, what the government then did not do was telling. The FDA never licensed the vaccine, or the oil adjuvant, for human use.
The Fort Dix experiment was the first time Army doctors and scientists injected an oil-boosted vaccine into U.S. troops without informed consent; there is now clinical evidence that it was far from the last. For more than a half century, factions in military medicine and in the U.S. public health establishment have actively campaigned to get an oily vaccine additive licensed, seemingly at any cost.
The Emperor's New Clothes
When scientists at Fort Detrick, following Joe Jemski's 1992 talk, reviewed the existing literature on the Wright vaccine, it didn't look good. Even with 6 shots, the vaccine did not protect very well. Guinea pigs vaccinated with the licensed human vaccine died when exposed to certain strains of anthrax. In 1986 the bad news got worse. In discovering that the licensed vaccine protected against the Army's old weapons strain, Vollum - from which the vaccine had been derived - Stephen Little and Gregory Knudson also discovered 8 more anthrax strains for which the PA vaccine did not work. Among them was the now notorious Ames strain that was mailed in 2001 anthrax letter attacks. Like the Army's previous research, the data confirmed that a live spore vaccine provided better protection against more strains. "The fact that the spore vaccine provided protection against all isolates tested suggests that other antigens may play a role in active immunity," they concluded. Which would argue for a live anthrax vaccine, but Fort Detrick's scientists expressed an age old concern about problem with living vaccines that could be traced all the way back to Pasteur: "Since this vaccine is a live immunogen," they warned, "safety factors must be considered before its use." Little and Knudson did not rule out the possibility of resorting to a live spore vaccine, but that is not what they then chose to pursue.
When they, along with Fort Detrick scientists Bruce Ivins and Sue Welkos, began working on a new anthrax vaccine, they chose a design that was all the rage at the NIH—subunit plus adjuvant. "Subunit" refers to small fragments of a germ. For safety, NIH scientists were using subunits of lethal viruses like HIV to be the chief component of their new generation of genetically engineered vaccines. These ultra-pure vaccines, which reduced an immunization to mere molecules from a microbe, were safe, but at a price. They were weak. In some cases, they afforded no detectable level of protection at all. This is why the NIH wanted an adjuvant more robust than alum for its new vaccines.
The subunit that Little, Knudson, Ivins and Welkos chose for the Army's new anthrax vaccine was a little surprising. It was protective antigen—the same main ingredient in the vaccine they were trying to replace. Although all the data from both U.S. and British military experiments from the 60's forward indicated that more components of the anthrax microbe needed to be in any effective anthrax vaccine—a fact that even Little and Knudson acknowledge in their 1986 paper—Fort Detrick's newest generation of anthrax investigators did just the opposite. In fact, they did one better. With recombinant DNA technology, their new vaccine would eliminate every extra molecule of anthrax unrelated to protective antigen. It would be purest PA formulation ever made, and would hence be the weakest anthrax vaccine ever made. Remember, in immunology, purity equals weakness.
Yet when Fort Detrick's scientists traveled to England in 1989 to report on their new vaccine to the International Workshop on Anthrax, they had some startling results to announce: Fort Detrick had found what everyone had been looking for: a single-shot anthrax vaccine. In guinea pigs, the new anthrax vaccine produced complete protection against the Ames strain with just one dose.

The trouble with anthrax

2004-10-25T17:40:00.000-07:00

I recently began to personally have quite a few symptoms that I have sought assistance for at a local VA Clinic. I am a Iraqi Freedom vet, whom until recently have had no signifcant medical problems. While in Kuwait I recieved four shots of Anthrax from a few Batches not sure which ones but I think fav078.

As a medic I was in charge of administering these vaccines to troops arriving in theather. I was in Kuwait from Jan 03 until June 03. I administered many injections probably in the thousands. I have begun this blog in order to try and creat a resource for soldiers and sailors equally to find answers on an illness that no VA doctor claims to be.

My symptoms are as follows; Severe onset acute reaction 3 times since I returned (07/03). ( red bumps on my trunk and arms after exhertion., or heat). Pain and numbness on the right side of my face constantly. Severe joint pain in my knees and pain in my back. Chronic fatigue.

This blog will be a resource for news and assistance. Recently a book has been released that I urge many of you to seek. I have acces to in and can send it to you for 24.95 called Vaccine A by Gary Matsumoto. Please email me with any infor you have. I am seeking the truth and assistance.