Judge Keeps Anthrax Suit Alive

By PETE YOST – MARCH 14, 2008

WASHINGTON (AP) — A federal judge Friday kept alive a lawsuit in which two Connecticut Air National Guard pilots said they were forced to resign nine years ago for refusing to be vaccinated against anthrax.

An Air Force panel must spell out the reasons for denying the two compensation for back pay and lost promotions, U.S. District Judge James Robertson ruled.

One of the pilots, Russell Dingle, died in 2005 and he is represented in the lawsuit by the executor of his estate. The other Connecticut Air National Guard pilot is Thomas Rempfer.

A federal court blocked the Pentagon's anthrax vaccination program in 2003, ruling that the vaccine had not been licensed or approved for use against inhalation anthrax. Other courts have ruled differently, affirming the legality of involuntary anthrax vaccination.

Robertson relied on the ruling that halted the vaccination program, saying that at the time the two pilots were refusing an order by their superiors, "it was a violation of federal law for military personnel to be subjected" to involuntary inoculation against anthrax.

The Food and Drug Administration has made changes in the vaccine that resulted in another court ruling two weeks ago by another federal court. That decision concluded the Pentagon can require its troops to be vaccinated against anthrax.

In the lawsuit of Rempfer and Dingle, they were assigned to a unit whose job it was to investigate the Pentagon's anthrax vaccination program in the late 1990s.

Rempfer and Dingle raised questions about the effectiveness and safety of the vaccine, but they said there was no satisfactory response from those higher in the chain of command.

Faced with what they considered an illegal order to be vaccinated or face discipline, both sought reassignment to the U.S. Air Force Reserves and were honorably discharged.

Reports prepared by superiors never mentioned their duties or their objections to the anthrax program.

The Air Force Board for Correction of Military Records must explain its conclusions about the claims by Rempfer and Dingle's family and about their demands for compensation, the judge ruled.

On the Net:

• Air Force Board for Correction of Military Records: http://boards.law.af.mil/AF_BCMR.htm

Here is a summary of the presentation I gave to the Maine Commission to Protect the Lives and Health of National Guard Members

Problems with Military Vaccines

Meryl Nass, MD

Although biological warfare is considered a military threat, achieving mass casualties is extremely difficult. Historically, the target has been civilians, not troops. Nonetheless, the Defense Department has undertaken to vaccinate all deploying soldiers to Central Command with anthrax and smallpox vaccines: approximately 1.8 million soldiers have received each in the past ten years.

In retrospect, the current administration used the threat of chemical and biological warfare to buttress a preemptive strike on Iraq in 2003. Initiating smallpox vaccinations for soldiers and civilians may have had more to do with public relations than public health. The civilian program stopped after 40,000 inoculations, due to cardiac complications.

Despite this, the mandatory military smallpox vaccination program has never slowed down. According to the CDC Advisory Committee for Immunization Practices, such vaccination programs require a risk-benefit analysis, which was never performed. The Institute of Medicine’s analysis of the smallpox program noted, “The combination of known vaccine-related problems and an immeasurable disease threat was deeply problematic.”

The smallpox vaccine caused myocarditis in one of every 145 people who received it in a clinical trial, leading to a black box warning in the label. However, the warning fell on deaf ears, since the vaccine remained a requirement for deployment.

Recently, a newer smallpox vaccine, derived from the old vaccine, was licensed. The government announced that stocks of the old vaccine would be destroyed, and the new vaccine would be given to soldiers. But is there really a difference? The new vaccine is said to cause myocarditis in one in 175 recipients.

The anthrax vaccine story is similar: the General Accounting Office reported to Congress in both 1999 and 2006 that the long-term safety of the vaccine is unknown. Crucial data and research remain buried.

Although civilians injured by smallpox vaccine can seek compensation from a government fund, soldiers are barred by the Feres Doctrine from compensation, and their only recourse in the event of illness is the healthcare system of the military and Veterans Administration. Unfortunately, vaccine-induced illnesses generally respond poorly to treatment.

In the absence of both demonstrable threat and effectiveness against biological weapons, these pork barrel vaccine programs exact much too high a price from our service-members and our treasury. It is time to end the politicization of military public health.

Anthrax Vaccine Lawsuit Dismissed: What Does That Mean?

Federal Judge Collyer last week dismissed a lawsuit challenging Biothrax's license on the basis that efficacy has not been demonstrated. The suit contended that anthrax vaccine had never been approved for its current intended use, inhalation anthrax.

The judge ruled that FDA is, in essence, the arbiter of the science and can interpret the data as FDA sees fit.

However, many articles in the medical literature and popular press over the past several years provide ample evidence that FDA makes judgments about products that are unsupported by scientific evidence. Congressman Jim McDermott, MD's Subcommittee will examine the use of psychotropic medicine on children in foster care next week (March 12)--a drug scandal FDA has chosen to ignore. The state of Alaska is suing the manufacturer of Zyprexa, seeking damages to pay for the care of those the drug made diabetic. Another drug scandal to which FDA turned a blind eye.

Time will tell whether "our" federal agencies will ever be brought to account. If federal agencies choose not to perform the tasks legally required of them, the value the federal government has to its citizens wanes. If we cannot "buy" quality public health, cannot obtain the oversight to ensure our drugs, foods and medical devices are reasonably safe and effective, and their review free of bias, why pay taxes to fund the FDA, CDC, and other public health agencies?

The "Hannah" autism case, in which a number of vaccines were judged by a Vaccine Court Special Master to have lead to a child developing autism, is the latest nail in the coffin of a totally politicized and unreliable federal public health enterprise.

Two stories: Israeli Army cedes supervision of experiments on troops to the Ministry of Health; Israeli Air Force refused to give pilots anthrax shots

http://www.ynetnews.com/articles/0,7340,L-3510509,00.html

Anthrax tests on troops to be conducted 'strictly under supervision'
Aviram Zino
Published: 02.24.08, 14:19 / Israel News

Following deliberation on petition protesting IDF medical experimentation on
soldiers, government announces Ministry of Health to supervise such
experiments.

State officials reported to the High Court of Justice on Sunday that all
medical experiments on IDF soldiers are to be conducted only under strict
Health Ministry supervision and approval.

The State also reported to the court that the Health Ministry protocol for
human experimentation is to be implemented in the IDF as standard command.

This announcement was made following a petition brought to the court by the
human rights group Physicians for Human Rights, in conjunction with several
Israeli Defense Force soldiers, protesting medical experimentation on active
duty soldiers in the IDF.

Most prominently, petitioners protested the use of IDF soldiers in secret
experiments testing Anthrax vaccines, codenamed "Omer 2".

Physicians For Human Rights petitioned the High Court three months ago,
demanding that the IDF stop medical experimentation on soldiers, and
demanding the establishment of a commission of inquiry on this matter.

The IDF soldiers petitioning the court demanded that they be compensated for
pain and suffering endured during such experimentation.

The "Omer 2" Anthrax experiment that triggered this petition was held
between 1999 and 2006, and included some 800 IDF soldiers. The experiment
included a series of seven injections, some including an American Anthrax
vaccine, and others a recently developed Israeli formula.

Physicians for Human Right has maintained that the experiment failed to
uphold several ethical imperatives, including garnering the informed consent
of the soldiers in question, as well as following up on their general health
and well being at the conclusion of the experiment.

Israeli law regulates medical experiments on human beings through
sub-ordinances rather than through major legislation. In the IDF, the
legislative status of human medical experiments is even more uncorroborated.

~~~~~~~~~~~~~
http://www.ynetnews.com/articles/0,7340,L-3401245,00.html
Guinea Pigs
May 17, 2007

TV documentary reveals army tested experimental anthrax vaccines on elite
combat soldiers, but refused to treat them after adverse symptoms appeared
Ines Ehrlich

The IDF secretly used elite combat soldiers as "guinea pigs" for
experimental anthrax vaccines, according to an expose broadcast Wednesday
night by the "Uvda" (Fact) documentary program.

Presenter Ilana Dayan revealed how in 2000, the army decided to carry out
anthrax antibody experiments ahead of independent manufacture in Israel.

According to the report, hundreds of young recruits into Israel's elite
combat units were offered the opportunity to partake in a top secret
experiment codenamed "Omer 2". They were led to believe they were performing
a national service of the utmost importance to the state.

The soldiers were told that the antibody had been approved by the American
FDA as far back as 1970 and was used on thousands of American military
personnel. It was explained that the experiment they would undergo
constituted the final phase prior to anthrax vaccine production in Israel,
which would cater to a possible eventuality of a biological attack on
military or civilian populations.

In 2004, a US district judge ruled that the program of anthrax vaccine for
use on American military personnel be stopped due to a series of side
effects experienced by US troops.

Classified information

Since 2000, the soldiers selected for the experiment underwent a series of
seven inoculations, all carried out in top secret, without even the
knowledge of their commanding officers. When various symptoms such as
serious skin lesions and pneumonia began to appear, the soldiers did not
relate them to the experiment and sought standard medical treatment provided
by the military.

Once soldiers began to suspect that there may be a connection between the
vaccines and their symptoms, they contacted the secret unit in charge of the
program and presented their case. The symptoms, it was explained to them,
had absolutely nothing to do with the inoculations.

Regular army doctors were unable to diagnose the mystery ailments without
knowing what drugs had been administered in the shots.

Nir, a fictitious name, who was interviewed throughout the program, was the
only soldier to receive the full series of seven shots. When forced to
involve his parents after being hospitalized, he tried to find out what the
vaccine contained so that he could receive adequate treatment. He called the
unit begging to be told what he had been given - his request was refused
outright as it was "classified information".

'Citizens can sleep peacefully'

Professor Tzvi Bentowitz, head of the research institute researching
infectious diseases at Ben Gurion University, said, "The fact that this
matter was shrouded in secrecy here while it created such an outcry in the
US is astonishing, to say the least."

The secret medical unit had also contacted the air force in an attempt to
recruit pilots for the experiment, but air force officials refused, saying
that possible side effects could interfere with pilots' performance.

In response, the IDF's chief doctor, Brigadier-General Hezi Levy, told the
program that the citizens of the State of Israel will be happy to know that
Israel has developed its own anthrax vaccine and can now "sleep peacefully".


He added that from now on the army would take full responsibility for any
adverse symptoms experienced by the group of soldiers, and that it would
coordinate treatments with the relevant medical institutions.

Editorial: Israeli government admits anthrax experiment caused injuries and takes responsibility for their care

w w w . h a a r e t z . c o m

Last update - 02:23 20/02/2008 Experiments in full responsibility By Haaretz Editorial The state's response to a High Court of Justice petition by soldiers who were subjected to medical experiments with anti-anthrax drugs (the experiments known as Omer 2) is a small but important step on the road to regulating one of the most neglected human rights issues in Israel. Admittedly, the state - in contrast to the soldiers - claims that the experiments were performed in accordance with accepted medical and ethical norms, and that there was nothing wrong with them. Nevertheless, it also stated, "The defense establishment bears full responsibility for the care of the soldiers who were harmed." This announcement includes two important points: an admission of the causal link between the experiments and the damage to the soldiers' health, and an assumption of full responsibility for the soldiers' care and treatment. The state thereby demonstrated a different approach than the one that has hitherto characterized the Defense Ministry, the chief of staff, the army's chief medical officer and the health minister. All had previously tried to deny any connection between the experiments and their results, as well as to evade any responsibility for the soldiers suffering to this day. As part of the Omer 2 experiments, some 800 soldiers doing their compulsory service were injected with a vaccination against anthrax, a disease that had been defined as one of the great dangers facing Israel's citizens. The soldiers who were chosen, all from elite units, accepted at face value the establishment's promises that they would suffer no side effects other than mild discomfort, and that the injection had been successfully tested in the United States. At the insistence of those conducting the experiment, the soldiers maintained strict secrecy and did not even inform their commanders. This secrecy was maintained even years later, when some of them developed serious symptoms: pneumonia, breathing problems, digestive tract inflammations, severe coughs, severe migraines, recurrent sores and other problems. Despite the army's promises of close and continuous medical monitoring, each of them was forced to deal with these problems on his own. Only in 2007, when some of the injured soldiers discovered that they were not alone in the war and began comparing their medical problems, was the story of the secret experiment finally revealed in the press, and a group was formed to go to the bodies responsible - this time in an organized fashion. The soldiers had a simple and reasonable demand: that the system recognize them as a distinct group and take responsibility for the harm done to them, and that it give them their medical files so that they could obtain appropriate treatment. When their repeated applications met only with repeated evasions, the group, numbering 34 soldiers, petitioned the High Court. As noted, the state's response to this petition bodes well. And no less important is its response to another petition, by Physicians for Human Rights, which asked the court to ban medical experiments on Israel Defense Forces personnel unless the issue is regulated through legislation. The state responded by undertaking to abide by certain interim restrictions until the necessary legislation is passed. This response, which does not evade a fundamental discussion of the question of experiments on human beings in general, and on IDF soldiers as a "captive audience" in particular, arouses hope that the defense establishment will finally grasp the importance of human rights, and that the suffering caused to the petitioners will serve as a warning to defense and medical personnel.

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Israeli government agrees to hand over data on anthrax vaccine tests

w w w . h a a r e t z . c o m

Last update - 02:14 19/02/2008 Soldiers sue government over harmful anthrax tests By Avirama Golan The state informed the High Court of Justice yesterday that it assumes full responsibility for the treatment of soldiers harmed during the testing of drugs countering the anthrax bacteria. The state was responding to a petition brought against senior officials last month by 34 soldiers who had been part of a biological weapons research project code named Omer-2. In its response, the state insists that the tests were carried out by the military authorities in line with accepted medical and ethical standards, through the application of strict safeguards, and with the authorization of all relevant parties. The state also said that there were no mistakes in the experiment. However it also said that "the defense establishment carries full responsibility for the treatment of soldiers who were injured by their participation in the research," and accepted the request of the soldiers to provide them with complete medical information and documents relevant to the experiment. The documents will be given to the soldiers "with a minimum number of deletions that are necessary for security purposes." The state was responding to a petition filed on behalf of the 34 soldiers by attorneys Boaz Ben-Tzur and Michael Sfard against the defense minister, the chief of staff, the chief medical officer in the Israel Defense Forces, and the minister of health. The petitioners argued that hundreds of soldiers were involved in the Omer-2 project in 1999, and that they received an injection of a mixture developed at the Biological Institute in Nes Tsiona. According to their petition, the process was flawed in the most basic ways, and that there were many violations of the law including basic standards set out by the law, such as the Helsinki Declaration on norms of experimentation on human beings. The soldiers also claim they had been presented with misleading, partial and false data on the tests, which had suggested that the side-effects of the trials would be minor and temporary. In practice, the petitioners claim, the soldiers suffered serious health problems as a result of the trials, including pneumonia, infections in the intestinal tract, coughing and spitting blood, migraines, and muscular problems. In a parallel petition filed by the organizations Physicians for Human Rights, the court is asked to ban all trials on humans in the IDF until the necessary legislation is passed - already approved in a first reading by the Knesset last year - on controlling and supervising such trials.

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One reason drugs may be used for years before risks become evident is that we have no active drug surveillance system-Mark McClellan, FDA Commissioner

Although no significant improvements in drug safety occurred while he was FDA Commissioner from 2002 to 2004, Dr. McClellan now acknowledges the need for improved safety surveillance at FDA, in a commentary in the April 26, 2007 New England Journal of Medicine.

This issue contains several articles on FDA assessment of drug safety. Jerry Avorn, a Harvard professor of pharmacoepidemiology, noted that 4 former FDA commissioners have called for an end to industry funding of FDA's new drug evaluations. As a result of industry funding, first introduced 15 years ago, FDA scientists were transferred from assessing drug safety to assessing new drug applications.

Dr. Avorn points out that FDA lacks the statutory authority to require companies to conduct follow-up studies of drugs after they are licensed. When FDA issues a new drug license, FDA is frequently very specific about the number and types of additional studies of safety and efficacy it expects to be performed. Yet despite this, the majority of postmarketing studies have not been done. According to the Federal Register, only 11% of 1,259 requested drug studies and 20% of requested biologics studies have been completed and reported on.

In 1970, at the time of licensure, the anthrax vaccine manufacturer was asked to conduct a clinical trial for efficacy, which never took place. Thirty-seven years after it was licensed, there is still no human efficacy data for the anthrax vaccine. (Don't even ask me about the quality of the safety data, which FDA has chosen to ignore.)

Final Defense Authorization Bill Includes Allen Provision that Seeks Answers about Vaccinations for Military Personnel

Wednesday December 12, 2007

Credits Barbara Damon-Day for her “determination to spare other military families distress about possible health risks to their loved ones”

Washington, D.C. (Wednesday, December 12, 2007)---U.S. Representative Tom Allen announced today that the House-Senate conference report on the defense authorization bill for Fiscal Year 2008 includes his amendment directing the Department of Defense to assess policies governing vaccinations given to military personnel. Representative Allen drafted the amendment in response to concerns about the possibility of serious health impacts from multiple vaccinations raised by one of his constituents, Barbara Damon-Day of Newcastle, Maine. Mrs. Damon-Day has been an outspoken advocate for such a policy assessment since her son, Captain Patrick Damon, died suddenly of undetermined causes in Bagram, Afghanistan during deployment with the 240th Engineer Group of the Maine National Guard.

“We vaccinate our Armed Forces to protect them from disease, but we must also protect them from potential serious harm that may result from multiple vaccinations administered at one time,” Representative Allen said. “The provision I included in the defense authorization bill requires the Defense Department to review its vaccination policy and make a report to Congress on how it minimizes any risks to our Armed Forces from multiple vaccinations. I am grateful to Barbara Damon-Day for her tireless effort to bring about these vaccinations to the attention of legislators and the public and for her determination to spare other military families distress about possible health risks to their loved ones who serve America overseas.”

“We need to do everything we can at the State and Federal level to protect our service members from non-combat injuries and deaths,” Barbara Damon-Day said. “They train for combat, but we lose more servicemen and women to non-combat deaths and we must work to make them as safe as possible.”

Pat Damon worked as a staff member in the Legislature and the Public Advocate’s office. Since his death in June 2006, Mrs. Damon-Day has led a campaign to improve the Defense Department’s medical screening of Armed Forces prior to their deployment overseas. Earlier this year, the Maine Legislature created a commission to improve medical screening of Maine Guard personnel before they go overseas.

contact: Mark Sullivan, (207)774-5019

More fake "science" on anthrax vaccine illness

Note: despite retiring from the military 17 months ago, John Grabenstein supervised the following study. Also note that a physical exam cannot identify Gulf War Syndrome (this has been widely acknowledged, and is one reason the existence of GWS was denied) or anthrax vaccine side effects 99% of the time--you need specialized tests for both. The patient's history and medical records are critical to making the diagnosis, not the physical exam. So why do a study of physical examinations, if not to deny the illness's existence? --Meryl


Assessing the Safety of Anthrax Immunization in US Army Aircrew Members via Physical Examination.

Journal of Occupational & Environmental Medicine. 49(10):1079-1085, October 2007.
Downing, Jill MD; Greig, Thomas W. MD, MPH; Quattlebaum, Martin D. MS; Valentin, Manuel MD; Heeren, Timothy C. PhD; Grabenstein, John D. RPh, PhD

Abstract:
Objective: Anthrax in weaponized form is the bioterrorism agent of most concern. Questions raised about the safety of the anthrax vaccine can be addressed by comparing immunized and unimmunized people in population-based studies.

Methods: A retrospective evaluation of data from periodic physical examinations collected on anthrax-immunized and -unimmunized US Army aircrew members between 1998 and 2005 was performed to evaluate the safety of anthrax immunization. Mean changes in variables found on physical examination and laboratory analysis were compared by use of t tests. Multiple linear regression predicted change in outcome from baseline characteristics.

Results: We compared 6820 immunized subjects and 4145 unimmunized controls based on US Army aircrew physical examination and screening laboratory tests. No association between anthrax immunization and a clinically relevant change in a tested physiologic parameter was detected.

Conclusions: No attributable risk of anthrax immunization was observed in this group of Army aircrew members.

Merck's failed HIV vaccine trial

This has nothing to do with biological warfare, but I feel compelled to make a few points about this trial anyway.

1. The volunteer subjects who received vaccine were apparently harmed. But did they receive sufficient warning that this could happen? Merck/NIAID will no doubt say it could not have been foreseen (though one article suggests the consent form stated that participation might decrease, increase, or have no effect on your risk of AIDS). Does this mean the lawyers knew the vaccine might be harmful but the doctors didn't?

A number of animal vaccines were developed, some even licensed, sold and used on pets and livestock -- when it turned out they increased susceptibility to the illness they were trying to protect against. This potential adverse effect should be well known to vaccine developers.

Not to mention the obvious -- small pilot trials of the vaccine should precede large-scale trials to rule out this dread complication. This was a Phase 3 trial in 3000 people.

2. The vaccine trial that took place in South Africa started at a later date (2007) than trials in the other countries started (2004). Yet it was the South African trial that blew the whistle on the increased rates of HIV in vaccine recipients. At that point, in late October, investigators from the earlier trials claimed they would have to evaluate their data to see if it bore out the South African findings. Now they admit their data confirms what the South African investigators identified: more HIV infections in those who received vaccine compared to placebo.

Guess what? Each trial of this vaccine was required to have a Data Safety Monitoring Board whose job is to monitor interim trial results to end a trial early if things are going wrong, as in this case -- and warn subjects if needed.

Clearly, this board was not doing its job in a timely fashion. Even worse, it is a good possibility that had the South Africans not blown the whistle, the other investigators might have attempted to sweep these data under the rug. Merck may have even tried to sell this vaccine, if it had been able to analyze the data in such a way this negative effect was not identified.

Why did it take the South Africans only months to see what the other centers only acknowledged last week, 3 years into the trial?

Although it sounds far-fetched, many pharmaceutical companies require medical investigators, even those at prestigious medical schools, to agree they will not get access to their own data, as a condition of being hired to conduct a clinical trial. Only the company gets to see the raw data.

The whitewashing has already begun: In Australia, investigator "Kelleher defended the protocol that halted the trial halfway on the advice of the Data Safety Monitoring Board and praised the transparency of the communication to participants."

But look back to the beginning of this fiasco becoming pubic: from the October 25, 2007 Washington Post:

Warning Is Sent to AIDS Vaccine Volunteers

...The Merck vaccine trials took place in 15 cities in the United States, including Boston, Los Angeles and New York, and three in Canada. There also were sites in Peru, Brazil, Australia, Haiti, the Dominican Republic and Jamaica. Those trials began in December 2004 and included 3,000 participants, mostly gay men.

In South Africa -- where an estimated 5.5 million people are infected with HIV, more than in any other country -- the study used the same vaccine but was administered separately. The trial here started later, with the first injections this year, and had its own ethics oversight board. Most of the subjects were heterosexual.

The ethics oversight board in the United States, which monitored the trial everywhere but in South Africa, has not decided whether to tell participants if they received the placebo or the vaccine, said Mark Feinberg, vice president for medical affairs and policy for Merck..."

Think of this article next time you considering volunteering for a scientific experiment

Report: President's Commission on Care for America's Returning Wounded Warriors

The motto of the report is "Serve, Support, Simplify." Further information on the Commission and report can be found at www.pccww.gov

Caution flag raised on mandatory anthrax vaccines

Former Air Force navigator says neurological reaction has left him disabled

By ELLEN GABLER
egabler@journalsentinel.com

Posted: Oct. 28, 2007

With his trim runner's build, tight flattop and thin, muscular arms, Stephen DeGuire does not seem like a man who is unable to empty the dishwasher, mow the lawn or throw baseballs to his young sons.

He forgets the names of neighbors he has known for years and grimaces as he pushes himself into a standing position. His torso tilts forward as he walks stiffly through his Mequon home. A wooden cane hangs on a chair in the living room. It is one of a collection that DeGuire keeps around. He frequently forgets where he puts them.

DeGuire is one of possibly thousands of veterans suffering from what some military and civilian doctors believe is a neurological reaction to the anthrax vaccine. The vaccine is controversial, yet now mandatory for many American troops and civilian contractors. About 1.6 million people have received the vaccine since 1998.

Nearly four years ago, DeGuire was stationed in Kuwait as a navigator for the U.S Air Force. Today, the 43-year-old struggles with migraines, memory problems, chronic pain and fatigue as his body slips further from his control.

DeGuire's Air Force physical evaluation in 2006 listed his ailments and noted that they began to occur after he received the vaccine.

While DeGuire's main concern is to keep his body from further deteriorating, he worries about his family's financial future. He said he makes one-third of what he made as a civilian and will likely never work full-time again because of his condition.

Disability linked to reaction from the anthrax vaccine is deemed non-combat-related, meaning veterans like DeGuire are taxed on their disability payments. The anthrax vaccine is also not part of the National Vaccine Injury Compensation Program, which allows people who suffered vaccine reactions to collect money for their disability. DeGuire worries about soldiers who will be required to receive the anthrax vaccine in the future. He says the program was "well-intentioned," but that officials in the government did not stop the vaccine when problems arose.

"They've had enough data to know there is something wrong with the vaccine," DeGuire said.

The Department of Defense made the anthrax vaccine mandatory in 1998 out of concern that enemies would use anthrax as biological warfare. If inhaled, the substance is usually fatal. Mandatory vaccines were halted in October 2004, when a judge questioned the Food and Drug Administration's approval procedures. In December 2005, the FDA gave final approval for the vaccine, and the Department of Defense made it mandatory again for soldiers and contractors serving in the Middle East, Central Asia and parts of Korea.

The Department of Defense maintains that the vaccine is "safe and effective." In a media conference call last fall, assistant defense secretary William Winkenwerder said that the vaccine had not led to increased deaths or hospitalizations.

Critics of the vaccine disagree. Physician Meryl Nass said her patients usually have 10 or 15 different diagnosis that she attributes to the anthrax vaccine - sleep disorders, fatigue, cognitive disability and higher rates of neurological disorders such as multiple sclerosis. A doctor in Maine, Nass testified about the vaccine in July before the House Veterans Affairs Health Subcommittee.

Nass also points to records collected by the Vaccine Adverse Reporting System, which catalogs vaccine complications. The system has received about 5,359 adverse event reports for anthrax vaccine. About 670 of the reports were considered "serious" and about 44 of the reports recorded deaths. In the reports, some soldiers or their families pleaded with the military to stop the vaccines.

Most vaccines are linked with side effects, ranging from simple soreness to death. But that's not much comfort to people like DeGuire, or other veterans he met while at Walter Reed Army Medical Center who also think they were affected by the anthrax vaccine.

Unlike many of those other veterans, DeGuire's case was recently accepted by the Mayo Clinic, so in early August, he lugged his three-inch-thick medical file to Rochester, Minn. While doctors are working on his physical problems, DeGuire and his family are pushing legislators to do something about veteran benefits and mandatory vaccines.

DeGuire said he has tried to no avail to have legislators introduce an amendment to the defense appropriations bill that would stop mandatory anthrax vaccines until more research is done.

Congress is considering changes on the benefits issue. The Disabled Veterans Tax Termination Act would give disabled veterans the same benefits as retired veterans with 20 years of service. The act is pending in the House subcommittee on disability assistance and memorial affairs. But no efforts are under way to reclassify ailments associated with the anthrax vaccine as combat related.

Two HIgh Court petitions in Israel over anthrax vaccine tests on soldiers

Group wants end to Israeli anthrax tests

Published: Nov. 1, 2007 at 9:36 AM

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JERUSALEM, Nov. 1 (UPI) -- A rights group petitioned Israel's High Court on Thursday to stop the military from performing anthrax vaccine experiments on soldiers.

Physicians for Human Rights filed one petition, while a second was filed by a group of soldiers seeking to be recognized as casualties of the experiments, Ynetnews.com reported.

From 1999 to 2006, some 800 soldiers underwent vaccinations of a vaccine developed in the United States and the rights group claimed in their petition scientific errors were made. They included tracking the soldiers' conditions consistently during and after the experiments, the report said.

The group also alleged the troops were misinformed of potential consequences of the tests and were given no opportunity to consult with non-military specialists for advice.

Attorney Michael Spharad, who filed the petition on behalf of the Physicians for Human Rights said the military had too much medical freedom.

"These days it is more difficult to experiment on animals than on humans," Spharad said.

Surveillance reveals anthrax vaccine safety an issue

Surveillance for Safety After Immunization: Vaccine Adverse Event Reporting System (VAERS) --- United States, 1991--2001

Surveillance Summaries

January 24, 2003 / 52(ss01);1-24

This CDC compilation of adverse event reporting information:

www.cdc.gov/mmwr/preview/mmwrhtml/ss5201a1.htm - Vol 52, No 1;1



tells us that anthrax vaccine had the highest reporting rate of adverse events for any currently licensed US vaccine, on page 15 of the CDC brochure (Table 3).

This rate is 91.8 reports per 100,000 doses distributed. It equals 3.7 reports per thousand vaccine recipients, since soldiers receive a total of 4 doses, on average. The only two vaccine with higher reporting rates in this table, Lyme and Rotavirus vaccines, were taken off the market due to safety concerns.

Yet DOD continues to claim that anthrax vaccine is as safe as any other vaccine.

Reply to Questions Posed by the House Veterans Affairs Committee regarding Gulf War Illnesses

To read the questions and answers, click here.

Guinea pig and mouse death rates after anthrax vaccine

This review compiles all the published guinea pig and mouse studies of Biothrax (aka AVA) anthrax vaccine, and compares it to the British, Russian and livestock anthrax vaccines. Biothrax gave the experimental animals the lowest survival rates compared to the other three vaccines. Click here.

Senate Veterans Affairs Testimony on Gulf War Veterans' Illnesses

My testimony to the Senate Veterans Affairs Committee was written to answer many persisting questions about these illnesses. It discussed the myths and the facts, while reviewing the recent research on Gulf War Syndrome. I tried to highlight what has been missing from the studies, and provide some ideas on where to go from here. Finally, I discuss the kinds of treatments I employ, and the barriers to receiving effective treatment for Gulf War veterans. Click on the testimony here.

The most arresting thing I heard in the hearing was the DOD physician's statement that 15-20% of current deployed troops to OIF and OEF are returning with ill-defined medical symptoms. This needs to be studied and remedied immediately.

Is Anthrax Vaccine Really Being Used to Save Soldiers from Anthrax?

Let's explore the reasoning for using anthrax vaccine.

It is supposed to protect you against anthrax. No studies of the current vaccine have been done in humans to see if it works, and how well it would work. It works in some animals but not others.

But for argument's sake, let's assume it works well. Will an enemy spray troops with anthrax if it knows the troops have all been vaccinated with an effective vaccine? Keep in mind that military doctrine calls for a powerful response to biological attack, which could include nuclear weapons. It's not very likely that an enemy would take such a big chance against effectively vaccinated troops, since there would be very little to gain.

If the enemy was serious about biological weapons, and ready to risk it all, the enemy would instead use a weapon that troops have no defense against, like botulism or Ebola.

This is a key concept: Anthrax vaccine isn't meant to save troops after an attack--its true purpose is to DETER an anthrax attack. Anthrax vaccine is also being given to soldiers to make a statement to Congress and to the world: vaccinations are "proof" that the US is prepared and ready for biological warfare.

But if the truth be known, the US is entirely unprepared for attacks by many types of bioweapons. We have no vaccine and no antibiotics for most viruses, for example, and no antidote for most toxins. Even bacteria can be made antibiotic-resistant.

Carrying a supply of doxycycline or cipro would provide an equal amount of deterrence as anthrax vaccine, with considerably less danger to troops, and at a much lower cost. DOD has been allowed to store most antibiotics for ten years to increase shelf life. This is not an approved option for vaccines, which is why the US will be wasting 100's of millions of dollars on anthrax vaccine that has been stockpiled by DHHS.

It would be better to do the logical, safer thing and have troops carry antibiotics, especially since units now have sensors for anthrax that can provide early warning of an attack. Besides, doxycycline is also a deterrent against brucella, plague, mycoplasma and some other biological weapons for which we have no effective vaccines.

It would also be better to acknowledge that we remain unprotected against a variety of chemical and biological weapons, and deal with this fact, since it is unlikely to change any time soon.

Bioport/Emergent Biosolutions Buys Another Republican Operative

August 29, 2007

Veteran GOP spokeswoman heads to private sector

by Jonathan Martin

RNC spokeswoman Tracey Schmitt is leaving the comfy confines of First Street S.E. to ply her PR skills in the corporate world. Schmitt, a SoCal native, will serve as director of corporate communications for Emergent BioSolutions, Inc., a Rockville, Md.-based biopharma company that develops vaccines that prevent and treat global and infectious diseases, with a particular focus on biodefense matters.

Though sought by GOP presidential campaigns, Schmitt could not be tempted to return to the frenetic campaign fray for a fifth consecutive cycle. She has been at the RNC since 2005, worked on President Bush's second inaugural, served as a regional spokeswoman for the Bush reelect, did a stint in the White House press shop before that and originally made her bones with the Austin crew way back in 2000.

Though she'll be doing well, she'll also be doing some good in her new gig. She is going to lead the multinational PR effort of a company that produces the only FDA-approved vaccine against anthrax being used to protect U.S. troops in the field.

Schmitt's last day at the RNC is next week and she'll begin life beyond the BlackBerry leash in late September.

Avoiding Liability: The Drug Licensing Game the FDA Plays With The Department of Defense

From 2003:

Click here to learn about 3 unusual licensing decisions, which circumvented liability for injuries caused by the following drug and vaccines:

Example 1: Pyridostigmine bromide (aka PB or NAPS tablets).

Example 2: Smallpox vaccine.

Example 3: Anthrax vaccine. "Fully licensed" for the first 520,000 military recipients

FDA documents show that "licensed" anthrax vaccine never demonstrated human efficacy

CDC, which performed some vaccine tests, acknowledged in 1968 that, "As to the efficacy of the vaccine, we have no real method of determining the protection afforded." FDA records show that in 1969 the ad hoc committee to license anthrax vaccine found a lack of "scientific evidence for efficacy of the vaccine." The committee chairman, Dr. Margaret Pittman, then noted, "Michigan has filed all required information and material for license except the results of an adequately controlled clinical investigation that establishes efficacy." Michigan was asked to conduct such a trial, but there is no evidence it was ever carried out. This demonstrates that the vaccine was never proven effective in humans.

Potency of the vaccine has been a continuous headache for the manufacturers. Many different potency standards have been submitted to FDA over the years. The potency assay kept changing because it could never be demonstrated to accurately reflect the potency of the product. One license amendment for potency was submitted in 1978. More were submitted prior to the first Gulf War. As recently as May 2001 Bioport was still submitting amendments to the potency test.

Therefore, FDA should have pulled the vaccine's license, since anthrax vaccine was unable to meet FDA standards for potency and human efficacy from the time the license was first issued. It means that FDA has never known whether or how much the vaccine will protect against anthrax.

"Improvement Needed in FDA’s Postmarket Decisionmaking and Oversight Process" -- GAO

Why is anthrax vaccine still on the market if it is as bad as this website claims? The reason has to do with gross failures of regulation at FDA. The Government Accountability Office said it better than I can, in a March 2006 report:

"FDA lacks clear and effective processes for making decisions about, and
providing management oversight of, postmarket safety issues. The process
has been limited by a lack of clarity about how decisions are made and about
organizational roles, insufficient oversight by management, and data
constraints. GAO observed that there is a lack of criteria for determining
what safety actions to take and when to take them."

('Postmarket' means after a drug has been given a license and is being sold to consumers, in contrast to the process of establishing safety of the drug in order to license it, for which FDA's process is generally more standardized.)

The bottom line is that FDA is totally politicized, and several doctors and scientists concerned about safety have been attacked by their superiors, as well as being prevented from giving talks and publishing papers. There has been ample evidence of this in the media and medical journals over the past several years.

Featured Quote

December 24, 2001
Dr. D.A. Henderson, Health and Human Services's director of public health preparedness, said,
"If this were a vaccine which… had no associated reactions [and]
would work very well, that would be one thing, but this vaccine does have
reactions associated with it, so there's a negative side to it."

Abusing Volunteers--Editorial in Israeli Ha'aretz Newspaper

July 28, 2007
A secret medical experiment that injected soldiers with the anti-anthrax vaccine, run over eight years beginning in 1998, raises alarming questions about the army authorities' conduct. To read the rest of the article, click here.

Testimony of Meryl Nass at House Veterans Affairs Health Subcommittee

On July 26, 2007 I spoke to the Committee on Veterans Affairs Health Subcommittee about the role of anthrax vaccine in Gulf War illnesses, and the role of the Department of Veterans Affairs in researching, diagnosing, treating and compensating ill veterans.

My written testimony is a 9 page summary of the science on anthrax vaccine safety and Gulf War illnesses, with recommendations for the Committee to improve the care of veterans who have been injured by anthrax vaccine or other Gulf War exposures.

My spoken testimony quickly summarized the information in the written testimony, and pulled no punches about why and how VA and DOD created a smokescreen around these illnesses to avoid caring for soldiers and veterans through a $260 million dollar portfolio of corrupt research.

670 SERIOUS Adverse Events Reported to FDA (includes 44 deaths)

FDA released its compilation of 670 SERIOUS adverse event reports filed with the VAERS system for anthrax vaccine.. This includes 44 deaths that were reported as suspected vaccine-related adverse events. You can review the entire list. Reports that FDA has designated serious comprise 12.5% of the total anthrax vaccine VAERS reports filed. The list is complete as of June 26, 2007. The total list of VAERS reports is also available. Click here.

US has stockpiled treatments for anthrax infections

The availability of treatments for anthrax after an exposure eliminates the need for pre-exposure vaccination. The National Strategic Stockpile now contains both antiserum and monoclonal antibodies for anthrax, in addition to a range of antibiotics that were added prior to the Project Bioshield acquisitions. General Russell, former commander at Fort Detrick, wrote the following:

Clin Infect Dis. 2007 Jul 15;45 Suppl 1:S68-72.

Project BioShield: what it is, why it is needed, and its accomplishments so far.

Russell PK.

Albert B. Sabin Vaccine Institute, Washington, DC 20005, USA. pkrussell@aol.com

Project BioShield is a comprehensive effort involving the US Department of Health and Human Services (HHS), its component agencies, and other partner federal agencies to speed the research, development, acquisition, and availability of medical countermeasures to improve the government's preparedness for and ability to counter chemical, biological, radiological, and nuclear threat agents. The legislation authorizes use of the Special Reserve Fund, which makes available $5.6 billion over 10 years for the advanced development and purchase of medical countermeasures. This appropriation is intended to provide an economic incentive to the pharmaceutical industry to develop medical countermeasures for which the government is the only significant market. Acquisitions under Project BioShield are restricted to products in development that are potentially licensable within 8 years from the time of contract award. In exercising the procurement authorities under Project BioShield, HHS has launched acquisition programs to address each of the 4 threat agents, including Bacillus anthracis (anthrax), smallpox virus, botulinum toxins, and radiological/nuclear agents, originally deemed by the Department of Homeland Security to be threats to the US population sufficient to affect national security. At the time of writing, 7 contracts have been awarded: (1) recombinant protective antigen anthrax vaccine, the next-generation anthrax vaccine (contract terminated in December 2006 for default); (2) anthrax vaccine adsorbed, the currently licensed anthrax vaccine; (3) anthrax therapeutics (monoclonal); (4) anthrax therapeutics (human immune globulin); (5) the pediatric formulation of potassium iodide; (6) Ca- and Zn-diethylenetriaminepentaacetate (DTPA), chelating agents to treat ingestion of certain radiological particles; and (7) botulinum antitoxins. Additional acquisition contracts are expected to be awarded in 2007.

Major Study into Long-Term Health Effects, 4/2000: Where are the Results?

DepSecDef Rudy deLeon testified to Congress on April 13, 2000 that federal agencies were working together to study the long-term effects of anthrax vaccine. Seven years later, where is the study? See National Guard Association report below:

Anthrax study conducted as supplies run low

"Federal agencies are collaborating in a major study into long-term health effects of the anthrax vaccine used by the Defense Department, Deputy Defense Secretary Rudy de Leon testified April 13 before the Senate Armed Services Committee...

The Centers for Disease Control in Atlanta is in charge of the $20 million, multi-year study and is working with the DOD, the Food and Drug Administration and the National Institutes of Health, de Leon said in a prepared statement. The study will document possible long-term effects and examine risk factors for adverse reactions and dosing for the vaccine.

"The DOD leadership ... [is] aware of and respects the concerns expressed by a small number of service members about possible long-term health effects," de Leon said. At least 12 studies involving more than 16,000 vaccine recipients have been conducted and show common short-term side effects include local injection site reactions, headache, slight fever, joint pain and fatigue..."

CBS News Investigates Anthrax Vaccine, 2007

Cynthia McKinney, former Congresswoman from Georgia, discusses anthrax vaccine

GAO Report: 1-2% have adverse events which may result in disability or death

On June 29, 2007 a Government Accountability Office report was issued regarding the military Vaccine Healthcare Centers, which were formed in 2001 to take care of injuries from anthrax vaccine. They have treated 2,400 ill soldiers, the vast majority for illnesses developing in close proximity to anthrax vaccinations.

Page 4 of the report says, "Officials from the VHC Network and CDC estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death." The text does not specify anthrax vaccine here, in an attempt to downplay the anthrax vaccine connection. However, on page 3 of the report, in a footnote, GAO makes clear that the only vaccine reactions evaluated for this report were those from anthrax, stating: "We consider the efforts of the VHC Network to address the needs of those receiving the anthrax immunization under both mandatory and voluntary circumstances to be within the scope of this report."

This quote from: Military Health: DOD's Vaccine Healthcare Centers Network. GAO-07-787R, June 29.
http://www.gao.gov/cgi-bin/getrpt?GAO-07-787R

Who would willingly agree to such odds? Yet this vaccine is what we continue to force on our soldiers, Coast Guard members, some merchant mariners and many civilian contractors to the military.

The GAO report says that the VHCs are working with the Military Vaccine Agency (MILVAX) to research adverse reactions--but no studies have been reported in the medical literature. It also notes the VHC Network spent $500,000 to build a clinic at Landstuhl, Germany in 2004--but the Army made no funds available to operate it. Landstuhl is where soldiers go first when they are medically evacuated from Iraq and Afghanistan. The VHCs apparently expected that vaccine-injured soldiers would be arriving at Landstuhl in sufficient numbers to warrant a clinic.

How many of the non-combat-related serious illnesses and deaths are due to anthrax and possibly other vaccines? Although the military has not released any data that would permit an independent assessment, I have heard from ill soldiers that several percent of their units were medevaced home prior to seeing any combat--due to heart attacks, gastrointestinal illnesses, and sudden development of autoimmune disorders.

Minimizing the Generation of Adverse Event Reports

There are only two large databases of information on anthrax vaccine and adverse reactions. The first is the Defense Medical Surveillance System (DMSS) database, which the two Institute of Medicine Committees (reporting in 2002 and 2003) studying anthrax vaccine said should be opened to independent researchers, and should receive more resources to better study anthrax vaccine safety. The second is the Vaccine Adverse Event Reporting System (VAERS), which is a collection of voluntary reports sent to FDA and CDC.

The DMSS database info has been hidden from the public since some of its data was given to the Institute of Medicine committee in 2001. (I have excerpted from this 2001 data in other parts of the blog.) That leaves us the VAERS reports. How are they being evaluated?

FDA allegedly has a terrible data management system for adverse events of both vaccines and drugs. Some employees said it wasn't fully computerized. FDA has just had to scuttle a very expensive, contracted upgrade to the system, and is starting out to develop another one. As if that wasn't bad enough, it appears that FDA does not get the reports from patients and medical providers directly. Instead, they go first to a private VAERS contractor, which processes the data and regularly presents it to FDA and CDC.

Because the VAERS system is so critical to identifying signals that require more investigation, and to assuring vaccine safety in general, three different federal advisory groups emphasized the importance of improving and increasing the generation of VAERS reports for anthrax vaccine:

1. In 1999, after many reports of military medical provider refusals to file VAERS reports when asked to do so by ill soldiers, the General Accounting Office (the investigative arm of Congress) reported the following to Congress:

We recommend that the Secretary of Defense direct the Secretary of the Army to improve DOD guidance and training on how to report adverse events to the Vaccine Adverse Event Reporting System... [Medical Readiness: DOD faces challenges in implementing its anthrax vaccine immunization program. GAO/NSIAD-00-36. October 1999.]

2. In 2000, the CDC's Advisory Committee on Immunization Practices, which formulates all vaccine policy recommendations for the United States, wrote the following:

To assess the safe use of anthrax vaccine in humans, the Advisory Committee on Immunization Practices recommends several areas of research. Adverse event surveillance through VAERS [FDA and CDC’s Vaccine Adverse Event Reporting System] should be enhanced, which could include development of electronic reporting capability and implementation of strategies to facilitate reporting. [Use of Anthrax Vaccine in the United States. MMWR 2000; 49: RR-15: 1-20. December 15, 2000.]

3. In 2002, the Institute of Medicine Committee to Assess the Safety and Efficacy of Anthrax Vaccine recommended that DOD increase and improve VAERS reporting by using codes to flag vaccine-related medical encounters:

DOD should develop and implement a system to automate the generation of VAERS reports with the military health care system, using codes to identify from automated records those health care visits that are potentially vaccine related. [Institute of Medicine Committee to Assess the Safety Safety and Efficacy of Anthrax Vaccine. The Anthrax Vaccine: Is It Safe? Does It Work? National Academies Press, Washington, D.C. March 2002].

At first, DOD appeared to make an effort to comply. The Vaccine Healthcare Centers website states that "The Vaccine Healthcare Center Network is dedicated to program development for quality improvement in VAERS." This webpage also says, "The VHC is also available to assist you in filing a VAERS. Anyone can file a VAERS, to include the patient and the patient's family."

However, although the VHC network at first filed VAERS reports for all the individuals they were evaluating for alleged vaccine reactions, this policy subsequently took a 180 degree turn. It has become apparent that for the past several years the VHC Network has not been filing VAERS reports for its patients, even for those whose records show the VHC believed them to have a serious adverse reaction to a vaccine.

Thus, the VHC website is apparently communicating a form of DOD doubletalk: its message should be interpreted as, "You, not we, can file a VAERS report, because we will not do so unless you demand our help."

What is the upshot of this failure to file? Probably 1,500 serious reactions that have been evaluated at the Vaccine Healthcare Centers, which produces extremely detailed, complete and accurate reports, have not been shared with FDA, CDC or the public. Thus, although the VHCs try to assist individuals who have been badly injured by the vaccine, they simultaneously collude to avoid sharing this information with the regulatory agencies which assess vaccine safety. This leads to poor regulation and more injured servicemembers. Thus the VHC data go into a black hole, the data that need to be evaluated by FDA and CDC and can be reviewed by the public on-line disappear, and the recommendations of the expert committees are bypassed by DOD--again.

Emergent Biosolutions/Bioport Board of Directors; How to sell to the US Government

Joe M. Allbaugh. Mr. Allbaugh was Chief of Staff to President George W. Bush from 1995 through 1999 when he was Governor of Texas. Mr. Allbaugh was later Director of the Federal Emergency Management Agency.

Louis Sullivan, MD. Dr. Sullivan served as Secretary of Health and Human Services in the cabinet of President George H.W. Bush from March 1989 to January 1993.

Jerome Hauer. Mr. Hauer served as acting assistant secretary for public health emergency preparedness of HHS from June 2002 to November 2003 and as director of the office ... of public health preparedness of HHS from May 2002 to June 2002. He also is said to have been responsible for putting the NYC Emergency Center in the World Trade Center prior to 9/11/2001.

Sue Bailey, D.O. Dr. Bailey served as Assistant Secretary of Defense for Health Affairs under President Clinton, where she headed the $17 billion military medical system, coordinating the care for 8 million beneficiaries. After leaving the Defense Department, she became the head of the National Highway Traffic Safety Administration.

From http://www.safetyforum.com/hoarlist/

"Sue Bailey, acting NHTSA administrator during the final months of the Clinton Administration, was the government's most visible official during congressional hearings and the controversy that swirled around defective Firestone Wilderness tires and the role of the Ford Explorer in more than 200 American deaths. While questions remained about the safety of the Explorer, Bailey became a consultant to Ford. Ford wanted Bailey on-board because "this is a public health issue, and she is an expert on public health issues," according to Ford spokesman Jason Vines."

Zsolt Harsanyi, PhD. Zsolt P. Harsányi Ph.D. has been President of Porton International, a pharmaceutical company, since 1984. He has benefited from spinoff of technology developed at Porton Down, the UK's equivalent of Fort Detrick, as did Emergent's major stockholder, Fuad El-Hibri.

Ronald Richards. Mr. Richard served as Chief Operating Officer and managing partner of In-Q-Tel, the CIA's Venture Capital Fund, for 15 months.


Admiral William Crowe, former Chairman of the Board., was also a former head of the Joint Chiefs of Staff and Ambassador to the United Kingdom. He has sold the Bioport shares he was given to act in this capacity, and is no longer affiliated with Emergent Biosolutions/Bioport. Reporter Bob Evans discussed how Bioport came to "earn" windfall profits.