Excellent websites to reference:

Anthrax Vaccine Network    AnthraxVaccine.org    Major Sonnie Bates 

http://www.life.com/Life/essay/gulfwar/gulf01.html.......don't miss this..

Despite promises that hospitalizations after anthrax vaccinations would be reported, the Pentagon withheld data on more than 20,000 cases.

Daily Press - Hampton Roads, Virginia

BY BOB EVANS
247-4758
December 4, 2005
First of four parts
http://www.dailypress.com/news/dp-71613sy0dec04,0,6004666.story?coll=dp-widget-news

bevans@dailypress.com 247-4758

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 hospitalized 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.

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. 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 acknowledgement 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.


SAILOR'S DEATH NOT REPORTED BY MILITARY

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, where she was regularly visited 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 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 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.


TOP GENERAL NOT TOLD MONITORING TO END

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.

None lasted as long as five years, the minimum length of time recommended by a nationally recognized panel of scientists assembled 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. Lawyers argued the case Thursday, and a decision is expected by February.


VACCINE MONITORING STILL IMPORTANT

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.

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 Congress was never told about the detailed level of data in the report but was assured regular monitoring of the vaccine and its health effects 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.


LINK BETWEEN VACCINE, HOSPITALIZATIONS?

Steve Robinson is executive director of the National Gulf War Resource Center, a lobbying and advocacy group for veterans. He said he was stunned when he learned that the reviews had stopped: "They track the flu vaccine and not the anthrax vaccine, which is totally crazy to me."

He said discovery of the hospitalization data showed that the Pentagon couldn't be trusted to monitor the vaccine's safety.

"You can't let Enron investigate Enron, and you can't let DOD (the Department of Defense) investigate DOD," he said. "We work with the people who have been hurt by this vaccine every day."

No one knows how many, or how few, of the 20,765 hospitalizations are directly attributable to the vaccine. Ruling out certain illnesses, such as broken bones or injuries from falls or other accidents, might appear a safe bet. But military doctors have documented cases where broken bones and other injuries from falling were the result of vaccine-induced loss of consciousness affecting the nervous system - sometimes beginning months after vaccination.

The difficulty of figuring out what's related and what isn't is why safety officials encourage people to file reports even if they're not sure.


WHY PENTAGON DIDN'T FILE HOSPITAL REPORTS

Still, medical experts consulted by the Daily Press said it's unlikely that the vast majority of the 20,765 hospitalizations resulted from the vaccine. They said that if all hospitalizations had been filed with VAERS, it would have overloaded the system and caused problems for experts trying to analyze the data.

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.

During the years covered by the hospitalization report obtained by the Daily Press, dozens of sick veterans who'd received the shot went to Capitol Hill, complaining of various health problems. Some got the shot for the 1991 Persian Gulf War, in which the vaccine had its first widespread use. Others were members of the military forced to take the shots under a mandatory program that began in 1998.

Their complaints had common themes: Fatigue. Chronic pain in joints and other symptoms of arthritis. Tingling in their feet, arms and hands. Mental lapses. Often, more than one of the symptoms were present, making diagnoses difficult.

Sympathetic doctors testified that these complaints were indicative of autoimmune problems, in which the body's natural protective mechanisms go haywire and start attacking healthy cells and tissue. The doctors said that could result if the vaccine overstimulated the vets' immune systems. The vaccine primes the system to develop protection against anthrax.

Bewildered and sometimes-angry members of Congress asked how many vets were affected. Pentagon doctors and generals used the cases reported to VAERS - fewer than 100 hospitalizations or other "serious events" from 1998 to 2000 - or said the number was so small, it couldn't be detected.


VACCINE REPORTS ARE FIRST LINE OF DEFENSE

The two sets of numbers for how many hospitalizations followed the shot come from a comparison of two sets of data kept by three federal agencies.

The Food and Drug Administration and the Centers for Disease Control and Prevention maintain the only database open to public inspection, VAERS. VAERS is the nation's first line of defense in identifying possible problems with vaccines after they've been licensed, said Susan Ellenberg, who led the FDA's efforts to monitor vaccine safety from 1993 to 2004.

During congressional testimony before the House Government Reform Committee's Subcommittee on National Security, Veterans Affairs and International Relations in July 1999, Ellenberg explained how and why the system worked.

VAERS was established to help identify and head off problems once a vaccine is licensed and more people are taking it, she said. The few hundred people typically involved in vaccine or drug testing and licensing trials can't mimic the diversity of age, race, gender and other biologic variables encountered once the vaccine gets widespread public use, she explained.

Reports to VAERS by civilian doctors and hospitals are mostly voluntary, based on suspicion of a connection between an illness or injury and a vaccination, Ellenberg told Congress.

Doctors and others are encouraged to file a report, known as a VAERS-1, even when they aren't sure there's a cause and effect, she said. That's because VAERS requires as many reports of problems as possible, so experts can identify possible patterns and investigate further, she said.


GENERALS' TESTIMONY PROMISED REPORTS

During the same congressional hearing, Lt. Gen. G. Robert Claypool - then the deputy assistant secretary of defense for health operations policy - assured Congress that military doctors, hospitals and medical officials were filing VAERS-1 forms, too.

And, he said, they were expected to report even more cases than civilians - including all hospitalizations.

"The duty to report adverse medication events has been codified for many years," Claypool testified. "The joint regulation requires submission of a form VAERS-1 for all adverse events resulting in more than 24 hours of lost duty time or any period of hospitalization. These requirements represent a higher standard than in comparable civilian community health care settings."

There was no mention that the word "all" didn't mean all hospitalizations.

Two months later, Lt. Gen. Ronald R. Blanck, then the Army's surgeon general and the top Pentagon official responsible for the anthrax vaccine program from 1998 to 2000, gave similar assurances to Congress.

He said, "We have a reporting system that when either of those two criteria are met, that is, either a patient is hospitalized following an anthrax immunization or misses duty because of it for greater than 24 hours, we have an active reporting system. That must be reported to us. We, in turn, report it to the Food and Drug Administration, and they have a group that reviews those reactions."

Clay and other congressional aides say these assurances came in private, too. "We had lengthy conversations that they were supposed to report," she said.

But the numbers reported were very low. And the Pentagon stuck with them for years to persuade the public that the shot was safe.

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.

He said, "The simple answer is it's so obvious, it's never appeared in the memo."


NO EXCEPTIONS NOTED IN POLICY MEMOS

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.

The data on all hospitalizations after anthrax vaccination comes from the Pentagon's Defense Medical Surveillance System, or DMSS. This computerized tracking system pulls medical records for every shot, clinic visit, hospitalization or other instance of medical treatment for active-duty military personnel.

Experts in health care and statistics say it's one of the most important medical databases in the world. That's because of its precision, its millions of patients, and the diversity of drugs and vaccines used by the armed forces. By design, it's more complete and accurate than VAERS. Unlike VAERS, its data isn't open to the public.


EXPERTS: NO EXCUSE FOR SECRET DATA

The Institute of Medicine report that Grabenstein cited as supporting the vaccine's safety and his decision to end the quarterly monitoring program also says the DMSS database should be open to researchers outside the government, with precautions to protect the privacy of individuals' health records.

This hasn't been done. Grabenstein said the military had not been able to figure out how to protect individuals' health records and make it work.

Strom of the institute panel and other experts say it should not be that difficult. "There's no excuse," he said. "We use these kinds of data sets in Medicaid and Medicare data all the time. There are technological solutions."

Cowan, another member of the panel, said the institute's recommendation was based, in part, on the military saying it couldn't afford all the analysis that the data was good for: "That way, you get the most of what the American people have invested in."

Strom said keeping the data from the public only bolstered the perception that the military was hiding the truth about the vaccine.

Walter Schumm is a professor of family studies and an expert on statistical methods at Kansas State University. He said he and other researchers would love to get the DMSS data. He's a retired Army colonel who's spent more than a decade using statistical analysis to examine the vaccine's safety - after friends and others in uniform began complaining about health problems after the shots.

Schumm has used other data made public on the anthrax vaccine to publish several scientific papers that poke holes in the safety assertions made by Pentagon doctors and researchers.

Good science involves people with different approaches to the same problem having a chance to test their theories, Schumm and others say. Their findings might cement the safety assertions, he said, but no one knows for sure until the military loosens its hold on the facts and data.

He said, "If you let independent people have the data, you risk losing control. In combat, letting things get out of control gets people killed, so loss of control is a very sensitive issue. I'm just sure they're trying to protect their program."

Victims of vaccine?
N.C. troops say military program is unsafe
http://www.charlotte.com/mld/charlotte/9763416.htm?1c

ELIZABETH LELAND

Charlotte Observer
Sun, Sep. 26, 2004

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.

. Anthrax comes from the Greek word for "coal" because infected skin forms ugly black lesions. . The rod-like bacteria were discovered in the 19th century. Louis Pasteur created the first vaccine in 1881. . 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-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.

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.

Other recent articles:

The shots of war
http://www.sptimes.com/2004/09/17/Floridian/The_shots_of_war.shtml
"Cristina Kutz thinks the anthrax vaccinations that she and other troops must undergo devastated her health. Her complaints are not unique, but doctors don't back her up."
By SUSAN ASCHOFF, Times Staff Writer, Published September 17, 2004

Mon May 21, 2007 8:34 am (PST)

Vaccine survey shows trouble at DAFB
Review of data shows those who got anthrax shot at Dover were more likely to fall ill

By HIRAN RATNAYAKE and LEE WILLIAMS / The News Journal
10/19/2004

http://www.delawareonline.com/newsjournal/local/2004/10/19vaccinesurveysh.html

 www.milvacs.org

Take the time to visit this website. This touching poem reveals the heart of website.

We will not desert you.
You, who have donned the uniform of our country and pledged your life to defend us,
We pledge to defend you with our honor, our work, the sweat of our brows,
Until you are no longer a medical experiment;
Until your pain is treated, and treated correctly;
Until your voice is heard and you are no longer ignored;
Until your sacrifices are recognized and you no longer have to defend yourself against your own government.
You do us honor in the face of those who would shame you.
We will walk with you.
We will not desert you.
 

http://www.channel4.com/apps26/news/news_story.jsp?storyId=851048

Squalene found in Anthrax vaccine
Breaking News: Britain

Published: 17-Mar-03; 03:23
By: ITN

Samples of anthrax vaccine have been found to contain a banned substance which could threaten troops' health.

 

Nov 25 2002
http://icnewcastle.icnetwork.co.uk/0100news/0100local/page.cfm?objectid=1240
1732&method=full&siteid=50081

By The Journal
 
Army veterans have branded a new report into Gulf War Syndrome commissioned by military top brass a "whitewash" after it said exposure to noxious chemicals was not the cause of their illnesses. The report, produced by the Government-backed Gulf War Illness Research Unit (GWIRU), concluded that health problems reported by veterans could not be blamed on vaccines used during the 1991 war, as some had claimed. The findings were last night greeted with anger by Shaun Rusling, North-based chairman of the National Gulf Veterans' Association, who said the report lacked both impartiality and credibility.

Many Gulf War Syndrome sufferers, backed by alternative academic research, believe that their condition is related to the use of organophosphates in insect repellent issued to soldiers fighting in Iraq and Kuwait. Others have linked the symptoms - which include muscle fatigue, loss of co-ordination and even problems encountered by sufferers of autism - to the use of vaccines and even the depleted uranium ammunition during the conflict. The Journal-backed campaign for justice for sufferers has now been running for almost a decade.

The MoD funded the latest research, carried out at Guy's, King's and St Thomas's Joint School of Medicine in London, in what they say was the most intensive neurological study of Gulf War soldiers in Britain to date.  Forty-nine veterans with neurological symptoms - national estimates say a total of 35,000 are suffering some sort of illness - were given exhaustive medical examinations, alongside a further 29 who had experienced no problems. The results were then compared to servicemen who had fought in Bosnia, as well as other personnel.

While the research team found there was no evidence that Gulf War veterans' symptoms were linked to brain damage, they did agree that their general health was poorer than that found in other groups of soldiers. That, says Mr Rusling, who served as a medic during the Gulf War, is a complete contradiction. "This is not surprising, given that the paper was funded by the MoD. Veterans were exposed to low level radiation, classified vaccines and anti-nerve gas pills in the Gulf.  "This has become a national disgrace, but the more the MoD tries to hide this away, the more they will be disbelieved. "All these desperately ill servicemen can't be wrong, but the MoD seems to be well and truly above the law."

But Professor Simon Wessely, who co-authored the report, said it was now clear that the health effects plaguing many of those who served in Operation Desert Storm was not associated with the brain or nervous system. "There is no smoking gun," he said. "There is no new disease that causes Gulf War Syndrome. There is a Gulf War health effect."

However, Malcolm Hooper, Emeritus Professor of Medicinal Chemistry at Sunderland University who has advised several veteran's groups, also claims the findings are seriously flawed. He believes the problems stem from damage to the central nervous system. "For this survey not to find any evidence of  neurological damage makes me very suspicious," he said. "I find this research unpersuasive and statistically insignificant." A spokesman for the Ministry of Defence said: "We note that the authors found no evidence for a specific neuro-muscular disorder that could be linked to deployment in the Gulf conflict. This should reassure all veterans.".   
 

VOLUME 38, NO. 34, September 24, 2002
Gulf War syndrome linked to anthrax vaccine
http://www.medicalpost.com/mdlink/english/members/medpost/data/3834/57A.HTM

By Pam Harrison

NEW ORLEANS - Symptoms of the elusive Gulf War Syndrome have now been linked to antibodies that target squalene, an experimental adjuvant used in some batches of anthrax vaccine received by 2.4 million U.S. military personnel as protection against the threat of bioterrorism.

Dr. Pamela Asa and colleagues from the Tulane University medical school here examined the association between symptoms of the syndrome and the anthrax vaccine used during the Anthrax Vaccine Immunization Program (AVIP) initiated by the U.S.  government in 1997. Researchers initially tested serum samples from six anthrax vaccine recipients and all six tested positive for anti-squalene antibodies. They then tested sera from 25 vaccine recipients and 19 controls who had not received the vaccine.

Thirty-two per cent tested positive for anti-squalene antibodies compared with 16% of controls. However, when researchers divided recipients into groups according to the lot of vaccine received, they found four lots of vaccine had been given to 17 of the 25, and in this group, eight subjects or 47% tested positive for anti-squalene antibodies.

None of the recipients who had received the vaccine from any other lot used during the AVIP campaign tested positive, a significant difference between the two groups despite the small number of samples tested, researchers note. Results of the study were reported in Experimental and Molecular Pathology. "Our testing for anti-squalene antibodies in persons receiving anthrax immunization as part of AVIP identified many antibody-positive individuals," researchers write. This is in contrast to the absence of anti-squalene antibodies observed in sera collected prior to immunization, they add. The U.S. Food and Drug Administration dismissed the amount of squalene found in certain lots of the anthrax vaccine as being too low to have an immunological effect.

But the immune system is "exquisitely sensitive to small quantities of antigen" and no lower safety limits have been set for squalene when used as an adjuvant in a vaccine. Symptoms of the syndrome include joint and muscle pain, dizziness, chronic headaches, low-grade fevers and memory loss.
 

http://www.timesonline.co.uk/article/0,,7-492718,00.html

The needle and the damage done

By Tim Reid
London Times
26 November 2002

Hundreds of American soldiers have suffered serious illness after being compulsorily injected with a controversial Anthrax vaccine, a batch of which has been found to be contaminated

   ON THE MORNING of December 17, 1998, Ronda Wilson, a supremely fit, strikingly beautiful American helicopter gunship pilot, was heading for military stardom. Just 21 and the only woman in her squadron, she had recently defeated her 63 male fellow pilots to earn the coveted Top Gun award in her first gunnery flight test. She was without peer in her cavalry unit, so skilled at handling the OH-58 Delta Warrior, armed with Hellfire missiles and .50-calibre machine guns, that she was described by her commanding officer as “one of the most outstanding pilots of her generation”.

On that morning, at Fort Stewart, Georgia, she received a routine order that was ultimately to destroy her faith in the military family and American government which she loved beyond question, and which she says “I was willing to die for”. She was told to “go get your jabs”.

She was never told what the injection was for, and felt no need to ask. It  was, she later discovered, the first in a six-dose course of anthrax vaccination. It was the moment she became part of the US government’s compulsory, highly ambitious anthrax vaccination programme for all 2.4  million of its military personnel; the project was authorised by President Clinton himself, it had begun eight months before, and it was halted 18 months later amid damning congressional verdicts, lawsuits and accusations of a top-level cover-up.

There were many things Wilson was not told about the 0.5ml phial of milky liquid that was being injected into her arm. It was manufactured by a company that today, after a new lease of life for the vaccination programme, has begun to distribute millions of doses to immunise “high-risk” US troops heading to the Persian Gulf for an attack on Iraq. (British soldiers will not be immunised with this vaccine, but with a home-grown version, produced at Porton Down).

Critics of the vaccine, who include congressmen, senior military officers and more than 450 American servicemen who have been court-martialled or forced to leave the military for refusing to take it, say its ability to combat inhalation anthrax has never been proven and it has never been tested on humans; it has never been licensed to combat inhalation anthrax; and its long term effects have never been known. Those claims are supported by a congressional committee which issued a scathing and alarming report into the efficacy and supervision of the vaccine, and the immunisation programme, in April 2000.

Its critics also claim it is being forced on the country’s soldiers as part  of a politically-inspired attempt to persuade the American public that an effective vaccine against an anthrax terror attack exists, and that its soldiers are safe from Saddam Hussein’s chemical and biological arsenal.

The Pentagon, and BioPort, the manufacturer, together with the Food and Drug Administration, which licenses US drugs, fiercely deny these claims. The Times has looked at thousands of pages of government, FDA, Army, congressional and medical reports stretching back 30 years. The extraordinary story of this anthrax vaccine, suddenly thrust on to centre stage in a new age of global terror, is one of high-level politics, furious scientific dispute, big business and great controversy.

One thing is certain — this vaccine has a history. Questions persist on two levels: the ability of the company that manufactures it to produce it safely, and the safety and effectiveness of the vaccine itself. There is testimony and documentation that raise the question of why the American military establishment and successive White House administrations have persisted with a company and a vaccine that by their own admission have suffered problems. It is a history that the hundreds of thousands of US troops about to receive the compulsory immunisation, and who have no right to refuse it, are not being told about.

Of all the things Wilson was not told about her first jab, perhaps the most crucial was this: that 10 months earlier, in February 1998, after an inspection of the Michigan laboratory that manufactures the vaccine, the plant had its authority to make the vaccine suspended by the FDA.

The inspection followed five years of warning letters citing concerns over the plant’s record-keeping and violations in safety, potency consistency and sterility. The February 1998 FDA report, which effectively prevented the plant from manufacturing fresh supplies of the vaccine for three years, and a copy of which has been obtained by The Times, is damning. The 95-page report found lots of the vaccine contaminated, a filtration process not authorised by the FDA, problems with cleanliness and the sterility of equipment and a failure to ensure a uniform potency of the drug.

“The firm routinely redates Anthrax Vaccine lots that have reached their labelled expiration date,” the report says. And it states: “Lot FAV036 was at room temperature for 20 hours, the filling operation was aborted, it was placed back in the refrigerator.” According to military records it was a dose from Lot FAV036 that was given to Wilson that December morning, eight months after the FDA report had been sent to BioPort.

“The patient reported no significant reactions with the first shot,” her final military medical report states — written in April 2001 when a depressed, emaciated and mentally confused Wilson was discharged from her unit — “except for an immediate large painful local reaction at the injection site (described as being slightly smaller than a golf ball). The pain extended from her shoulder to her elbow. The military medical community reassured her this was normal. She also reported the onset of about three headaches a week.”

After her second jab, from a different lot, in January 1999, she developed “irritability, loss of memory, fatigue. By late February to early March nausea and diarrhoea started. One week after her third anthrax vaccine dose her gastro-intestinal symptoms worsened further, evolving into her current disabling state of illness.”

That current state is pitiful. Wilson, who four years ago was in superb health and in charge of one of the most potent weapons in the US armoury, can barely drive a car. She has lost a third of her body weight and suffers such agonising cramps every day that she is forced to curl up in a fetal position for hours at a time. She has stiff joints, chronic fatigue, anaemia, difficulty with simple sums, memory loss, blackouts, permanent abdominal pain and, according to her medical report, “loss of cognitive function”.

She is sure the anthrax jabs caused her physical and mental degeneration, but understands the difficulty in proving it. The final medical report concluded: “There were no other risk factors present . . . that could account for her symptoms. The anthrax vaccination may have adversely affected her immunological balance. There is a clear temporal association with the onset of her illness and her anthrax vaccination. While it is not possible to scientifically prove causality between anthrax vaccination and the onset of her illness, it is impossible to disprove causality.”

Wilson understands those problems of proof. What has destroyed her trust in everything she once held dear — the US military, the US government and her husband, a fellow pilot who has now left her — is that for 18 months she was led to believe she was a freak, the only soldier to have become ill after the injections, a strange one-off. Military doctors would diagnose stress, Aids, leukaemia, anything except a possible link to the vaccination. And, she says, as soon as she became ill, “they couldn’t wait to get rid of me”.

But in the summer of 2000, at the Walter Reed Army Medical Centre in Washington DC, she met another soldier reduced to a sad husk by, he claimed, an anthrax jab. He began to tell her what he had learnt about the vaccine, and about the hundreds of soldiers who claim it has made them chronically ill with fatigue, auto-immune diseases, severe joint pain and infertility.

It was a story that left Wilson feeling “betrayed by everything I once believed in”. Sitting in her rented flat in Savannah, Georgia, and often close to tears, she asks: “How could they not tell me the history of this drug, to make me believe I was an aberration?”

Jon Irelan, a retired Army major and US Ranger, was on a tour of duty in Saudi Arabia in 1999 when he was given four anthrax jabs. Soon he was losing his hair and suffering fevers and muscular weakness, mood swings and bed-sweats. Ultimately he discovered that his testicles had shrivelled up and died. He will be on testosterone injections for the rest of his life. “Right from the beginning they refused to send me to an American medical facility,” he says. .“They kept sending me to Saudi doctors. They told me it was a freak reaction. There were guys being airlifted to the Army Hospital in Germany for ingrowing toenails. I thought I was an anomaly.”

In June 2000 Irelan, back in the US, contacted his congressman, Washington State’s Jack Metcalfe, who sat on the House Government Reform Committee which was investigating the vaccine. “His office told me I was not alone. Then I started receiving calls from others, telling me I was not crazy. The calls have not stopped. “I would have been happy to accept this if I had been told the problems with the vaccine. Shit happens. But they treated me like a dog.”

In October 2000, Irelan gave evidence before the House committee. “Members of Congress,” he said, “I appear before you today to tell you that I would willingly lay down my life for the United States of America. But what I wish someone would explain is why it has been permitted to perpetrate this unproven drug on my fellow soldiers.” It was a question worth asking, because a long paper trail shows how concerned the US Government has been about the vaccine for more than 15 years.

The first anthrax vaccine was designed in the 1950s to protect wool-mill workers from cutaneous anthrax, which enters the body through breaks in the skin. In 1970 the federal government issued the only licence to manufacture a similar vaccine to the Michigan Department of Public Health. That later became the state-owned Michigan Biologic Products Institute (MBPI). That licence was based on a scientific study of an earlier vaccine which had suggested an effectiveness against inhalation anthrax. “There was a presumption of effectiveness, but it has never been tested, which is a legal requirement,” says a congressional aide on the House Government Reform Committee, which had called for the immunisation programme to be suspended in April 2000.

By the late 1980s MBPI, with antiquated facilities, was making small batches of the vaccine, about 15,000 to 17,000 doses every four years, selling them mostly to people in the animal hides business. It was the only US company making an anthrax vaccine. With the reduction in the relevance of nuclear weapons, the Cold War now over, the US Army had begun to take an interest in chemical and biological warfare. It investigated the possibility of contracting MBPI to supply the US military with the vaccine. This was before vaccinations became politically sensitive, and the Army and Pentagon statements are now a matter of public record. They are striking in their  bluntness.

In 1985 a US Army report stated: “There is no vaccine in current use which will safely and effectively protect against all strains of the anthrax bacillus. A licensed vaccine against anthrax . . . is currently available for human use. The vaccine is, however, highly reactogenic, requires multiple boosters to maintain immunity and may not be protective against all strains of anthrax bacillus.”

In 1989, a year after the Army had gone ahead with ordering 300,000 doses from MBPI, a letter from the Pentagon to Senator John Glenn stated: “Current vaccines, particularly the anthrax vaccine, do not readily lend themselves to use in mass troop immunisation for a variety of reasons, a higher than desirable rate of reactogenicity, and, in some cases, lack of strong enough  efficacy against infection by the aerosol route of exposure.” Then came the Gulf War. Amid claims that the vaccine may have caused the illness of thousands of troops after 150,000 were vaccinated — allegations never proved — hearings were held by the Senate Veterans Affairs Committee.

In December 1994 it stated: “The efficacy of the vaccine against biological warfare is unknown.” In the 1994 medical textbook Vaccines, Colonel Arthur Friedlander, the US Army’s chief anthrax vaccine researcher, wrote: “The current vaccine against anthrax is unsatisfactory for several reasons. The vaccine is composed of an undefined crude culture . . . the degree of purity is unknown . . . the presence of constituents that may be undesirable may account for the level of reactogenicity observed.” This is the same vaccine — the same ingredients, if not the same batch — being administered to troops today. In October 2000, Col Friedlander gave evidence to the House committee. He said: “This vaccine is safe and effective, and it’s the best vaccine we have to protect against this disease.”

Col Friedlander says he has taken the vaccine himself. There is no reason to believe his assertion before the committee was not genuinely held. One thing, however, had changed: the determination of the US government to immunise the entire military.

Throughout the 1990s, MBPI had been manufacturing millions of doses in the conditions so damned by the February 1998 FDA inspection, as political demands for the vaccine grew. In 1996 the Khobar Towers bombing in Saudi Arabia killed 19 US troops. Pan-Arab terrorism had begun in earnest. The spectre of biological terrorism was becoming a genuine political concern. So  the Army again looked at the anthrax vaccine. This time the plan was bold: a mass immunisation programme for all 2.4 million servicemen and women.

In 1995 the Army contracted the SAIC Corporation, consultants to the Pentagon, to submit a plan that would enable them to obtain an FDA licence for inhalation anthrax. In its report, the SAIC’s plan clearly identified the vaccine’s legal status: “This vaccine is not licensed for aerosol exposure expected in a biological warfare environment.” Under US law, the lack of such a licence meant that soldiers could not be given the vaccine without their “informed consent”, a hurdle that would have made a mass immunisation programme impossible.

On September 20, 1996, MBPI submitted an Investigational New Drug (IND) application to the FDA. Again, one of its purposes was clear: “To obtain a specific indication for inhalation anthrax.” That IND application has never been acted upon by the FDA. Six months later the FDA’s stance on the vaccine appeared to change. In 1997 a new Defence Secretary, William Cohen, made combating bio-terrorism a priority. On March 4, 1997, four days after the retirement of the long-serving FDA Commissioner David Kessler, the Assistant US Defence Secretary (Health Affairs), Dr Stephen Joseph, wrote to the acting FDA  Commissioner, Dr Michael Friedman. Dr Joseph said the Defence Department had “long interpreted” the vaccine as being effective for inhalation anthrax. This was six months after the IND application.

Dr Friedman replied on March 13. It was a response that seemed to clear the regulatory hurdle for a mass immunisation programme: “While there is a paucity of data regarding the effectiveness of Anthrax Vaccine for prevention of inhalation anthrax, the current package insert does not preclude the use.” The insert said the vaccine was licensed for “at risk” industrial and  veterinary workers. It did not specify the type of infection.

Meanwhile, MBPI was in financial trouble. In June 1998 a private consortium named BioPort, headed by a Lebanese businessman, Fuad El-Hibri, bought the company for $24 million. A major shareholder and director of BioPort was Admiral William Crowe, Chairman of the Joint Chiefs of Staff under the Reagan and Bush Senior administrations, and a friend of El-Hibri; the two met while  Crowe was Ambassador to the UK.

Less than a month after the sale of MBPI, BioPort landed an exclusive $29 million contract with the Pentagon to “manufacture, test, bottle and store the anthrax vaccine.” Admiral Crowe has vehemently denied that he knew of the deal before BioPort purchased MBPI. He also insists that the vaccine is safe.

Within months, BioPort too was in trouble. Unable to rectify in time the problems highlighted in the FDA’s February 1998 inspection report, the new owner, like MBPI before it, was unable to ship any new vaccine. It appealed to the Pentagon for more money. By June 2000 the Anthrax Vaccine Immunisation Programme (AVIP) had all but ended, due in large part to dwindling supplies.  Not until January this year was BioPort authorised to start shipping new vaccines. But between March 1998 and January 2000, according to the Pentagon’s own figures, 2.1 million doses of stockpiled, pre-February 1998 vaccines were administered to 535,000 troops. Only in August did the FDA prohibit BioPort from using any pre-1998 vaccine. During that period the Pentagon spent over $100 million of taxpayers’ money renovating the plant. It is also paying about $20 a dose, more than three times the original price negotiated three years ago. And critics point out that no matter how much  money has been spent renovating the plant and cleaning up the manufacturing process, the vaccine itself, given to troops heading to the Gulf today, has not changed.

Six months after the FDA inspection of the plant, Captain Tom Rempfer and Major Russ Dingle, officers in the Connecticut Air National Guard, were asked by their commanding officer to look into the vaccine. Misgivings about the jabs had begun to spread, and it was felt that their investigation would put the minds of fellow pilots at rest.

It didn’t. The two officers wanted to go public when they discovered the FDA inspection report. Senior officers in their unit, they say, ordered them to keep their discovery secret. They then refused to take the jab, and were ordered to resign their commissions. Both pilots have filed federal lawsuits against BioPort challenging the effectiveness of the vaccine. The sister of  Sandra Larson, a soldier who died three months after her sixth jab, has also been joined by Ronda Wilson in suing BioPort. Their lawyer, Alan Milstein, says he hopes to bring a class action involving hundreds of former  servicemen. Their cases, they say, have been greatly helped by the House of Representatives.

In April 2000, after days of testimony, the House Government Reform Committee released its verdict on the vaccine. It stated: “The AVIP programme . . . leaves the Department of Defence captive to old technology and a single, untested company . . . based on a dangerously narrow scientific and medical foundation. The safety of the vaccine is not being monitored adequately.” As  a health care effort, “the AVIP compromises the practice of medicine to achieve military objectives.”

It derided the “preposterously low” adverse reaction rates reported by the Pentagon, which is “more concerned with public relations than effective force protection”. It adds: “Adverse events following vaccination are reported by women at twice the rate among men.” And it concludes: “AVIP raises an ominous question: who protects the force from ill-conceived force protection?” The House committee, chaired by Dan Burton and Christopher Shays, both Republican congressman, recommended that the AVIP programme be suspended. Lawrence Halloran, a senior aide to Shays, says: “The FDA was leant on by the Department of Defence in 1997, and took a shortcut. They interpreted the old licence on the fly, giving the vaccine approval. It is not a standard you would find anywhere else. No other drug manufacturer would be given approval for a product like this.

“The committee concluded that it is not licensed for inhalation anthrax. There is no question it is harmful to some people’s health. To persist with using this vaccine at the expense of developing a new one is a scandal.”
So how can the Pentagon be allowed to vaccinate troops with such a discredited product? “Because they can,” Halloran says. “They felt a desperate need to have something at hand, and this was already on the shelf. After the Gulf War they panicked, and felt they had to do something. They have the weight to intimidate the FDA into ignoring the problems.”

In August the FDA acknowledged problems with the vaccine. The product insert was altered dramatically. It said the vaccine could harm people with immunity disorders, could cause a host of serious long-term adverse reactions and could already be responsible for six deaths and a number of birth defects. According to the Pentagon, of the 535,000 troops inoculated, 1,578 have reported adverse reactions with 208 classified as “serious”.

The insert warnings were based in part on a report by the US General Accounting Office earlier this year, which stated that adverse reactions occur in five to 35 per cent of people who take the injection, vastly higher than a previous Pentagon claim of only 0.2 per cent. The GAO also criticised the pressure exerted on troops not to report adverse effects, so as not to jeopardize their military careers.

James Turner, a Pentagon spokesman, says: “The vaccine is safe and effective. Period.” He points to the FDA’s own evaluation of the vaccine. Kim Brennan Root, of BioPort, refers to the product insert, which states: “BioThrax is also indicated for individuals at high risk of exposure to bacillus anthracis spores.” She says: “It doesn’t say it is licensed for one type of anthrax  over another. There are three types: inhalation, cutaneous and intestinal. The critics keep pointing to the 1996 IND application. They say the license does not specify inhalation anthrax. Well, the license merely specifies that it protects against the disease, regardless of what form you contract. If you follow the critics’ line of argument, we would have to expose people to high levels of inhalation challenge. We have monkey studies which support the effectiveness of the product for all three types.”

In August the FDA gave a 25-page, point-by-point response to a Citizen’s Petition filed by Major Dingle. It stated that in 1972, when the FDA assumed responsibility for regulating the drugs industry, independent panels reviewed the vaccine, concluding that it is “safe and effective”. Referring to its own February 1998 inspection of BioPort, the FDA states: “Inspectional observations do not necessarily render the anthrax vaccine unsafe or  ineffective.”

Their assurances are of little comfort to Ronda Wilson. She says: “Everybody said I should get over my anger. But anger is the only thing that gets me out of bed in the morning. I have lost my marriage, my career, my dreams, my future, my pleasures. I would have died for my country. But I didn't think I would die like this.”

 

My name is Dennis Drew. I am an active duty service member stationed at Ft. Hood, Texas. This is a summary of how my life has changed after receiving the anthrax vaccine in March 2003: I had just completed basic training in very good health and shape. I did fracture my  pelvis, but I kept on going, determined to finish. That has healed now. I  graduated March 19, 2003 and was then stationed at Ft. Hood, Texas. On  March 24, I received the anthrax and typhoid vaccines in preparation for  deployment. On March 27th, I woke up feeling ill. I felt like I was getting the flu. I had body aches, sore throat, nausea and a headache.

Later that day I started feeling worse. I began to get a sharp pain in my chest and was having trouble breathing and started sweating for no reason. On March 28th, I returned to Maine to see my family before I was to leave for Iraq. I got worse as I was there and ended up going to Maine Medical Center where I was diagnosed with severe pneumonia and myocarditis. My symptoms have gotten worse ever since. I came back to Ft. Hood the first week of April and went to the medical clinic for a follow up. I was told I had permanent damage to my heart. I began feeling worse and eventually checked in to the emergency room. They ran tests on me and even sent me to San Antonio for additional testing. The doctors down there called me a 'medical mystery.' I have been to the hospital emergency room more times than I can count and was made to wait hours before I was seen. Every single time I was told that there was nothing wrong with me and they sent me home. The last week of April my family moved down here and had to take care of me. Now, I can hardly walk or stand for more than 5 minutes. I have chronic headaches, muscle weakness, chronic fatigue, nausea, chest pains, numerous colds, memory loss and a 30lb weight loss.

Over the past few months of dealing with this, my unit was not supportive. They treated me terribly and a few of my superiors told me I was faking. I went to sick call almost daily, which turned out to be the best thing I could have done. There, I was always made to see different doctors and got many different diagnosis; such as lupus, chronic myocarditis, lyme disease and rheumatoid arthritis. However, blood tests later showed these diagnosis to be false. My Commander noticed I wasn't getting better. In an attempt to help me, he had me assigned to a doctor in internal medicine, Dr. Klotz. After 2 or 3 visits and a few tests, Dr. Klotz said he didn't know what to do for me anymore. He had suspected a vaccine reaction in the beginning and filed a VAERS report to the CDC. When he told me he didn't know what to do for me anymore, I asked to go to Walter Reed thinking maybe they could determine if I was having a vaccine reaction. He told me I could not go until he knew what was wrong. His suggestion was that I wait 3-6 months and if I wasn't better, they would consider a discharge. I don't understand why they would consider discharging me without sending me to Walter Reed. After all, I thought I was supposed to be getting the best medical attention possible. My whole experience thus far with the medical care at Ft. Hood has been a joke. I ended up contacting Walter Reed myself and they wanted to see me, but I couldn't go without a doctor here recommending that I needed to go.

Eventually, with the help of a higher ranking friend, I was able to get in touch with a doctor at one of the clinics. I met with him for almost 2 hours and he recommended me to Walter Reed. I was then referred to Col. Dalzell at the clinic to be my PCP. She also thought I was having a vaccine reaction and with the help of Walter Reed, was able to get me there quickly. Finally, on July 28th, after much difficulty from my unit, I arrived at Walter Reed. However, right before I was supposed to leave for Walter Reed, I was made to have a psychiatric evaluation performed by Major Jennifer Lang. I met with her for an hour and we discussed my family, my frustrations with the medical care I had been receiving and we also talked a little about my illness. After just an hour of talking and no prior knowledge of my current medical situation, she concluded that I have a somatization disorder- basically, that I am making all of this up and just wanted people to feel sorry for me. I thought it was absurd that she could even say something like that after only 1 visit and no prior knowledge of what I had been going through. My case worker at Walter Reed saw the diagnosis and thought it was premature and unnecessary. After a having a variety of tests run on me at Walter Reed, they determined that I had chronic fatigue syndrome and fibromyalgia caused by the anthrax vaccine. I also have small vessel ischemia in my brain, but they are still uncertain of its origin. I was also made to have a neuropsych evaluation. After talking with the doctor for 30 minutes, he then handed me off to his assistant and she administered the test. I just got the results a few days ago and the doctors diagnosis was that I was a malingerer and that I was suffering from somatization. I was really upset about this. I have no reason to be making this up. Some people have suggested that it is stress-related, but this cannot possibly be true. Yes, I have dealt with many stressful circumstances recently, but I am no malingerer. When I was at basic training I had to deal with not seeing my wife and son for 6 months. I also missed the birth of my daughter and fractured my pelvis. All of these events were stressful, but I was able to deal with them fine. My goal was to retire from the military after 20 years of service, not to end up like this. I can't pick my 2 small children up. I can't go places or do anything. It has affected not only me, but my wife and children as well. I can't get a second job to support my family and my wife can't work because I can't take care of our kids or myself. Our finances have been destroyed. I hate not being able to be the best husband, father and provider that I can be. If I am making all of this up, I am losing a lot more than my health. This is a large burden that my family and I have to carry around because not many other people want to accept the blame for what has happened to me. This is a great burden to deal with and it makes it even harder when I have people that don't believe that I am truly sick. I have nothing to hide. I would love to invite anyone who doesn't believe in the adverse reaction of the anthrax vaccine to come spend a day in my home- to see first hand what my family and I go through. We will fight for the rest of our lives so that myself and other military personnel like me will be acknowledged as having a reaction to the anthrax vaccine. We are not malingerers and we are not fakers. We are just victims of wanting to serve our country. Even after all I have been through, I still don't want out of the military. I am proud of what I signed up to do. However, I have been told that discharge is in my best interest and that is what will happen to me.

We are people too with a real illness and deserve to be treated fairly. These past 6 months I have tried to be fair and respectful to the healthcare system of the military but I can't stand by anymore. I realize that there could be some retribution from the Army about this but I am an American citizen and I have the right to voice my opinion. The best advice I can give to anyone suffering through any vaccine is to be persistent- very persistent. Go to sick call as much as you have to. Keep records of everything. My wife, kids and I will most likely be dealing with this for the rest of our lives and we will fight until the day we die for other people like us.

Thank you very much.
Sincerely,

Dennis W. Drew
 

KEY: ER =enlisted recruit; OA =officer accessions (includes Academy unless specified); Academy = service academy
Note: The Armed Forces began to include hepatitis B vaccine in their list of basic immunizations for new recruits in 2002.
Source: "A Report for The Armed Forces Epidemiological Board" August 1999 [43]

http://www.nytimes.com/2002/12/17/health/17TROO.html?tntemail1

BIOLOGICAL DEFENSES
Pentagon Faces Difficulties in Smallpox Shots for Troops
By DENISE GRADY





"
But the presence of people in the military who must avoid the vaccine may pose logistical difficulties. Such people must also avoid close contact with others who have been recently vaccinated, because for two to three weeks the vaccination site can shed the live virus, vaccinia, used in the vaccine.

Australian SAS could be offered experimental vaccines
http://www.smh.com.au/articles/2002/12/21/1040174434938.html
By Fia Cumming, Political Correspondent
December 22 2002
The Sun-Herald

Australian SAS troops are likely to be offered experimental vaccines against anthrax, mustard gas and bubonic plague if they are deployed to a war on Iraq.As a US decision on whether to attack Iraq looms, preparations for an Australian contribution are winding up. Vaccination plans for British and American troops are already under way, but the Australian Defence Department will not reveal which vaccines may be offered to Australian soldiers. A spokeswoman said the information could be used by other countries.

"It's a matter of operational security," she said. "We vaccinate in line with a threat and risk assessment, based on what operational environment they are entering into." Iraq is known to have had stocks of VX, a liquid nerve poison, sarin and tabun nerve gases and anthrax, and is suspected of having other biological and chemical agents.Australian troops - mainly SAS - may be offered the vaccines on a voluntary basis, because of the problems which arose after the Gulf War. American, British and Australian defence personnel said they developed mysterious and lingering illnesses, known as Gulf War syndrome, as a result of the vaccines.

The Howard Government last weekend received 50,000 imported doses of smallpox vaccine as a precaution against a terrorist attack. But because of its risks, the vaccine will not be used unless the disease is released by a terrorist. Australian Defence Association executive director Michael O'Connor said providing vaccines was normal when troops went overseas.

 

Exhaustive exams... I love it... My husband had one of  those 'exhaustive exams' because of his ongoing gastrointestinal problems since the Gulf War.  It lasted about 3 minutes, the Dr  didn't even know how to fill out the paperwork for the report to the administration, and NO ONE followed up with my husband... makes me exhausted.
 

    http://www.signonsandiego.com/news/metro/20021224-9999_1m24sick.html
      Deadly bacteria infection overwhelmed MCRD recruit
    
                         By Jeanette Steele
      UNION-TRIBUNE STAFF WRITER

      December 24, 2002

                All recruits entering MCRD are vaccinated against the meningococcal bacteria, which usually affects young people . Still, Malone said the vaccine isn't always effective, as in Zavala's case.     

From John Rappaport's StratiaWire's Newsletter:

Monday, December 23, 2002

UPDATE---SMALLPOX VACCINE OP

DECEMBER 23. I have had time to consult with several very good sources, and this is what is happening with the smallpox vaccine. There is a full-court press on the major media to keep them from saying, THE GOVERNMENT HAS REVERSED ITS POSITION ON THE VACCINE. THE GOVERNMENT SCREWED UP BIG-TIME. How long this pressure will succeed we don’t know. But so far the media campaign of OMISSION is working. The dumbed-down public is buying the moment-by-moment coverage without connecting the dots.

Too busy shopping and making plans for the holidays. In point of fact, the government could have begun leaking its reversal-of-position info a lot earlier, but now is perfect. Xmas rules all. The amazing “confession” data re the vaccine FROM THE MAINSTREAM PRESS is a series of planned leaks. This is all orchestrated, for reasons I’ve been mentioning in recent articles. It’s being made to look like responsible medical bureaucrats have the public interest at heart. Some of them do. But overall, this is a story about heavy protection of the vaccine industry from exposure, since the smallpox vaccine is so dangerous and toxic.

The CDC is now scrambling to do two things: one, tell those thousands of community vaccine centers they have been setting up, all across America, to back off on the smallpox shot; and two, retain the STRUCTURE of those centers, a new infrastructure for all sorts of medical OPS (covert operations), including, of course, vaccines to be given in the event of a PURPOSELY STAGED “biowar attack.”

However, because the prior propaganda about the importance of getting the smallpox shot was so successful, there will be people who insist on getting the vaccine. Some of them will get very sick, and some will die.The government is not willing to simply say, “Well, we warned you.” That is not enough. That is not going to carry the day. So as many of these deaths as possible will be attributed to other causes. But it is likely there will be problems. As I write this, legal experts are working to figure out how the government should deal with the liability, and PR firms are weighing in, too, to concoct spin trips to minimize bad press. Odds are, the vaccine manufacturers will stay out of the spotlight.

Whatever heat there is to take, the government will take it. This, in fact, was the whole point of the VAERS system of liability payouts that was put into effect in 1986. Get the drug companies off the hook and involve claimants in a maze of government pros who could stall God from making it rain. Okay? So now we have to ask, if the government has been making an amazing reversal of opinion and policy in the last week on the smallpox vaccine, why did they ever support mass vaccinations in the first place? Why say yes and then say no later on, when the liability exposure is so fraught with danger?

This part of the story is definitely DEVELOPING, as they say in the news business.

Was Bush told to launch the mass vaccination program by people who were stupid, who didn’t understand what could happen? Did Tommy Thompson, Bush’s secretary of health and human services, tell him to do this? Thompson knows nothing about these matters, as far as the science is concerned. If the urging for a green light came from Thompson, then HE had been briefed by others first. Was Bush urged to give the green light by George Tenet, the CIA director? Did Tenet think he had good information that a smallpox bio-attack might be imminent? If it was Thompson or Tenet, who had briefed these men first? We know that Bush is impulsive, and that he gets advice from his people and tends to jump into action without reflection.

There is another possibility. Somebody ran an OP on Bush. Somebody wanted him to do exactly the wrong thing. Somebody wanted to him to be the dupe for an eventual vaccine disaster of enormous proportions. A Gerald Ford with his absurd swine flu vaccine fiasco. Only much worse. Can you imagine the damage Bush would have suffered (and could still suffer) if he had given the final okay for a mandate to vaccinate the whole nation? People dying like flies, photos, the whole war on terrorism cast as a medical screw-up of the first order?
Bush’s Waterloo.

Judging from the rising tide of negative opinion about the vaccine coming from the CDC and NIH over the last few months, it’s unlikely that the original instigator for this mass vaccination program came from official channels at these two giant federal agencies. And you see, as long as the major media refuse to pursue the story of the government 180-degree turnaround on the smallpox-vaccine issue, reporters are not going to ask Bush, “Who convinced you this was a good idea in the first place?”

I have spoken with my prime source on propaganda matters, Ellis Medavoy. He said, “You have to look for layers of people here. You have to build a chain of people to see where the idea for this mass vaccination came from. It’s quite possible that someone within the intelligence cartel was the real source. Someone who WANTED a disaster. Because disasters are what create the kind of chaos certain people want. (I have referred to these elements in past articles as the Plan B people). They are not satisfied with the slow-drip method of gaining more control over the global population. They want to burn down everything to the ground and build a steel-trap society on the ruins.”

Bush is still up against it. The Army is vaccinating lots of soldiers. How successful will the cover-up of deaths be? Well, it’s a lot easier to manage that behind the military walls than out in the public. Bush is still on the hook as the dupe. How do you make a dupe? You feed him information which merges with his general outlook, you give him a detailed suggestion as to action, and you stand back and let him go to work.

In the case of instituting that VAERS (Vaccine Adverse Event Reporting System) in 1986 that took vaccine manufactures off