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.

Selected Findings and Research Recommendations of Eight Different Committees that have Studied Anthrax Vaccine since 1998

I compiled selected recommendations of the House Government Reform Committee and seven federal advisory committees that were charged with investigating the vaccine program. These recommendations regard additional, needed research on vaccine safety. Click here for their findings.

DOD'S Current Policy on Exemptions from Anthrax Vaccine

This slide is from a DOD presentation to medical providers.

The Committee on Government Reform issued a report on the anthrax vaccine program in 2000 titled "Unproven Force Protection"

Here is the report in its entirety.

DOD Misinforms Congress and the Public on Anthrax Vaccine Safety

DoD produced and distributed a long memo alleging that both short and long-term safety of anthrax vaccine have been established: "There are no known long-term patterns of side effects from the anthrax vaccine, based on an ongoing series of studies..."

I decided to annotate the document to correct many of its errors and omissions.

Army Surgeon General Warned Medical Providers to be Aware of Serious Vaccine Adverse Effects--click here

Every Expert Committee that has Investigated Anthrax Vaccine Agrees that Long-term Safety Studies are Needed--click here

Vaccine Healthcare Center physicians identify new muscle disease related to anthrax vaccinations

I discovered the following 3 year old conference presentation on the internet. Information on this syndrome has not been published in the medical literature, nor is information about it available on the VHC website. The recorded presentation is of great interest.

Thursday, May 13, 2004 - 11:45 AM
5034

Reproducible Prolonged Myalgia Syndrome (RPMS) Following Multiple Anthrax Vaccinations: Draft of A New Rare Adverse Event Case Definition Developed by The Vaccine Healthcare Centers (VHC) Network

Renata Engler¹, Jeanette Williams², Limone C. Collins², and Michael R. Nelson². (1) Allergy-Immunology Department, Walter Reed Army MEdical Center - US Army, 6900 Georgia Ave, NW, Washington, DC, USA, (2) Walter Reed Vaccine Healthcare Center, US government, 6900 Georgia Ave, NW, Washington, DC, USA

BACKGROUND:
The Vaccine Healthcare Centers Network is a Department of Defense (DoD) new medical advance developed in response to increasing concerns about rare adverse events temporally linked with mandatory vaccines and the need to provide clinical support services for persistent or more severe adverse events. Myalgias and body aches with varying features of fatigue and arthralgias (without any evidence of joint inflammation or stiffness) are a common side effects reported following routine vaccination. The symptoms are generally of short duration resolving in a few days and responding to over-the-counter analgesics. A small percent of vaccinees develop more severe or prolonged symptoms raising concerns about the safety of continued vaccination in a series.

OBJECTIVE:
To present a draft vaccine adverse event case definition from a vaccine safety clinical case review program focusing on a subset of patients who experienced reproducible prolonged myalgia syndrome following multiple doses of anthrax vaccination.

METHOD:
The VHC Network provides clinical expert consultations and case management services for DoD beneficiaries who experience adverse events that are more severe and/or prolonged than expected side effects. A systematic review process to identify patients with adverse events identified the cluster of patients described.

RESULT:
Five cases (male, age range 29 to 52 years, 3 Caucasian, 2 African Americans) who had received 19 doses of anthrax vaccine are described to include details of an informed consent re-challenge that resulted in symptoms lasting more than 4 months and responding to corticosteroid therapy.

CONCLUSION:
Prolonged and more severe myalgias, arthralgias and fatigue, particularly when recurring and worsening with each subsequent dose of a vaccine, results in fear of long term disability. Further studies are needed to improve understanding of this syndrome with a focus on prevention and treatment.

LEARNING OBJECTIVES:
To understand the post anthrax vaccine clinical presentation of prolonged and more severe myalgias.

• Recorded presentation

Congress demanded detailed research on anthrax vaccine in 1999

The Congressional Record (HR Rep. No. 106-371 at 254-55) shows that on October 8, 1999 it stated, "The Department[of Defense] is directed to enter into a contract with the National Research Council to independently study the effectiveness and safety of the anthrax vaccine. The following issues shall be considered in the report: the types and severity of adverse reactions, including gender differences; long-term health implications; inhalational efficacy of the vaccine against all known anthrax strains; correlation of animal models to safety and effectiveness in humans; validation of the manufacturing process focusing on, but not limited to discrepancies identified by the Food and Drug Administration in February 1998; definition of vaccine components in terms of the protective antigen and other bacterial products and constituents; identification of gaps in the existing research."

Although the Institute of Medicine Committee did offer opinions as to the vaccine's safety and effectiveness in its 2002 report, its opinions did not reflect the existing literature on efficacy--which makes clear that efficacy is uncertain for inhaled, weaponized anthrax. Its opinions on safety are contradictory. All the questions Congress posed in 1999 have yet to be resolved, with the exception that gender differences are real and women sustain 2-3 times more adverse systemic reactions than men.

Military Physicians Identify Serious Autoimmune Lung Disease Caused by Anthrax Vaccine

Navy doctors discuss a case of bronchiolitis obliterans that developed shortly after anthrax vaccination. They ruled out other causes of the condition. Their review was published in a highly regarded pulmonary journal. I am aware of other cases of this potentially devastating illness that developed in close temporal relationship to anthrax vaccine.

In this critical letter to the editor and author reply, one sees how extensive the review of this case was, in order to make the claim for a link between the vaccine and subsequent illness. The pre-publication review took nearly a year, and included medical specialists from NIH, the Armed Forces Institute of Pathology, and both the Air Force and Navy Surgeon Generals' offices, who agreed with the authors.

Congress Tried to Solve the Problems with Anthrax Vaccine, But Failed

Congress tried to fix the worst aspects of the anthrax vaccine program, and obtain more reliable information on anthrax vaccine between 1999 and 2002.

Congress appears to have failed for two reasons: it does not like to step on DOD's toes, and it was outsmarted.

Congress demanded Vaccine Healthcare Centers

Congress likes win-win situations and has tried to solve the anthrax vaccine problem by creating win-win solutions. When it faced the wrath of the upper levels of the Department of Defense, on the one hand, and injured and scared troops, on the other, instead of ending the vaccine program, Congress mandated the creation of Vaccine Healthcare Centers, where those who believed they had received a vaccine injury would be treated, and their illnesses could be researched.

The House–Senate conference report that was generated in conjunction with fiscal year 2001 appropriations legislation and with fiscal year 2001 funding provided by Public Law 106-554 said the following:

“Regarding the anthrax study, the conferees understand that clinical studies will be greatly facilitated by the establishment of the Vaccine Healthcare Center Network, with the first site at Walter Reed Army Medical Center. This Network will facilitate data collection, standardization of the anthrax immunization, training and general data collection for this project.”

However, six years later, soldiers do receive treatment at the four Vaccine Healthcare Centers --but overall, no one has been cured, and only a few have been significantly improved. The Centers themselves have had to fight for funding each year, and face threats of closure. They have done research, according to a 2007 talk by the Clinics' founder/director, Renata Engler M.D., recently retired head of Allergy-Immunology at Walter Reed Army Medical Center. But none of it has been published in medical journals or made available to the public. Only one 2002 abstract, describing the first 82 patients treated, can be found. Yet over 2,000 more patients have had complete evaluations at the Vaccine Healthcare Centers since.

Dr. Engler has given a number of talks about anthrax vaccine issues, many of which are available on the internet. On the one hand, while on active duty, Dr. Engler claimed that vaccine safety concerns have been based on rare cases -- but on the other hand, she also said in April 2007 that serious adverse events in 1-2% of vaccine recipients may need exemption management, and admitted that the adverse effects from mixtures of drugs and vaccines are unknown. One million six hundred thousand soldiers have received anthrax vaccinations since 1998. If 2% had a serious adverse reaction, that would be 32,000 already-injured people.

Thus the Vaccine Healthcare Centers, at Walter Reed, Fort Bragg NC, Norfolk VA and Wilford Hall TX, have neither clarified questions regarding adverse reactions from anthrax or other vaccines used in the military, nor have they developed curative treatment protocols. Most military medical providers are not aware the Centers exist, and injured soldiers frequently fail to be referred to them for assistance.

Congress demanded Medical Research on Anthrax Vaccine

Congress also required that the Centers for Disease Control and Prevention (CDC) research adverse reactions to anthrax vaccine. To ensure that adequate and effective research projects were undertaken, Congress demanded in 2000 that an Institute of Medicine Committee be formed to guide CDC in this endeavor.

The Institute of Medicine Committee did a good job of evaluating CDC's proposed research projects and recommending which were most valuable. This Committee also emphasized the need to perform longitudinal research to assess the possibility of reactions developing months or years after vaccination. Its report was published in 2003.

However, CDC (which has been paid many millions of dollars by DOD to do this research) has failed to follow the Institute of Medicine recommendations regarding use of military medical databases to assess long-term adverse events. Its one published study, of optic neuritis following vaccinations, used an arbitrary cutoff of 18 weeks following vaccination for a diagnosis of optic neuritis to be made. (Incidentally, this required that soldiers had to receive the diagnosis while in a war zone, given the fact they are vaccinated immediately before deploying to Iraq or Afghanistan for six to twelve months. This virtually guaranteed that only the most severe cases would meet the inclusion criteria established by CDC.) It was therefore no wonder that, although military optic neuritis hospitalizations are much commoner after anthrax vaccination, CDC failed to find more cases in the vaccinated. Other studies are pending, but are being carried out by the same group that 'cooked' this first study. I expect they will reach whatever conclusion the funder desires.

Congress supported research on 2nd and 3d generation "replacement" anthrax vaccines

However, the 2nd generation VaxGen anthrax vaccine, made by using a higher concentration of the same active ingredient as the current anthrax vaccine, Biothrax, failed during advanced development, and will not be able to supercede Biothrax. HHS cancelled the contract in December 2006.

The National Institutes of Health rescinded their proposal to fund research on a 3d generation anthrax vaccine in March, when they were dissatisfied with all the proposals submitted. Currently no anthrax vaccines appear to be in development, and no replacement for Biothrax is in the works.

Emergent Biosolutions, a.k.a. Bioport, spent millions to acquire a lobbying "dream team" -- then sold 10 million more vaccine doses to the government for civilian use!

Bioport has had on its payroll a former US Secretary of the Department of Health and Human Services, retired Generals, a former head of the Joint Chiefs of Staff, a former Assistant Secretary of Defense for Health Affairs and many others who had responsibility for biodefense procurement in their former roles in government. One of the PR firms employed by Emergent Biosolutions is DC Navigators, which boasts of its ability to do its own grassroots organizing. DC Navigators has had as clients 8 state Governors and 8 US Senators, among others. Emergent spent over 2 million dollars in 2006 alone on nine lobbying firms.

Perhaps as a result, NIH is now considering purchase of 22.75 million more doses for the civilian stockpile. The current cost is $24.78 per dose, or $563 million for this addition to the National Strategic Stockpile. The original 10 million doses of anthrax vaccine in the civilian stockpile cost approximately $220 million. Military vaccine has cost at least an additional $100 million. All told, Emergent Biosolutions has done extraordinarily well since purchasing the vaccine manufacturer for $25 million in 1998, when the vaccine cost about $3.00 per dose.

Fear-mongers scared Americans with images of anthrax weapons and mushroom clouds.

Now we know it was all hype--but we didn't know it then. Failing to prepare for an anthrax attack by Saddam Hussein's troops would have made Congress appear careless. Just in case Congress didn't get it, real anthrax spores were sent to the Capitol, leading to enormous fear throughout the United States, a prolonged and expensive clean-up, and billions of dollars appropriated for responses to bioterrorism, including plenty of anthrax vaccine.

Congress did its job -- but nothing changed

Congress held 13 hearings that dealt with anthrax vaccine between 1999 and 2001. Congress commissioned studies on anthrax vaccine from the GAO, the Congressional Research Service, and the Institute of Medicine. Congress made sure specialized medical care for vaccine-injured soldiers was made available within the military.

Congress learned the vaccine was only questionably effective. Congress learned some people were being severely injured by the vaccine. What was unclear then, and remains unclear today, is how many are injured, how badly, by what mechanisms, and whether they ever recover.

By late 2000, vaccinations had ceased due to multiple manufacturing failures at the anthrax vaccine plant. No new vaccine could be shipped out. FDA withheld a license for the manufacturing facility, even after it was completely renovated at taxpayer expense. Then the anthrax letters were sent, and HHS Secretary Tommy Thompson insisted the anthrax plant would be given its license. Thompson also gave DOD an "Emergency Use Authorization" to use anthrax vaccine after its license was lost in 2004.

In 2004, a lawsuit challenging the vaccine's licensing process led to the license being suspended, and mandatory vaccinations ceasing for two years. Subsequently, the FDA issued the comment period that had previously been missed, ignored the many scientific challenges the comment period generated, and reapproved the vaccine license. Resumption of mandatory vaccinations was announced in October 2006, and several hundred thousand soldiers have since been vaccinated.

It's deja vu all over again: No documented threat. A suspect manufacturer. A vaccine unlikely to be effective against weaponized anthrax made by a skilled adversary. And lots more people being harmed.

Unfortunately, the vaccine produced now is no better than the vaccine made in the old facility. The FDA continues to receive adverse event reports at the same rate as before: one in every 250-300 recipients reports problems to the FDA Vaccine Adverse Event Reporting System. And the director of the Vaccine Healthcare Centers, Dr. Renata Engler, who has data on thousands of reactions, said there are "No apparent differences between pre-renovation and post-renovation lots."

Congress used various means at its disposal to ameliorate the worst problems associated with anthrax vaccine, and attempted to assure the vaccine was thoroughly investigated. Yet these measures have been thwarted, the research corrupted and the military medical data withheld. False threats were manufactured to spur biodefense spending, including the purchase of inadequate but already existing "solutions" like anthrax vaccine.

It is now time, after nine years of the on-again, off-again anthrax vaccine program, for Congress to stop mandatory vaccinations unless and until a proven safe, effective vaccine becomes available.

Mental Disorders were also linked to anthrax vaccine in data supplied to the Institute of Medicine

Overall, hospitalizations for mental disorders overall more than doubled after anthrax vaccinations. For servicemembers who received one to three vaccine doses, hospitalization rates for mental illness tripled following vaccination.

Hospitalizations for affective psychosis in those who received at least one and less than four doses of vaccine were five times greater than before vaccination. In the same group, hospitalizations for "adjustment reaction" tripled. Hospitalizations for "personality disorders" more than quadrupled. Hospitalizations for depression nearly tripled.

Not every illness is more common after anthrax vaccination. Hospitalizations for the majority of ordinary diagnoses do not rise.

These data, generated by the Army's Medical Surveillance Activity in 2001, are very suggestive that anthrax vaccine affects the brain in susceptible recipients.

Anthrax vaccine related to multiple cancers and other illnesses:

Army statistics provided to Institute of Medicine in 2001 but never published

What conditions are found much more often after anthrax vaccinations? The list is surprising, and (unsurprisingly) women are especially affected. This series of 3 tables does not give us the raw data, instead providing data that has been statistically adjusted by the army. Where does this data come from?

Benign breast lumps leading to hospitalization occurred a whopping 9 times as often after anthrax vaccinations as before. Breast and genitourinary cancer hospitalizations occurred more than 3.5 times as often. Abnormal PAP smears led to hospitalization more than 5 times as often after vaccination.

Hospitalizations for nerve damage in the arm--usually the vaccinated arm--or several damaged nerves (mononeuritis multiplex) occurred 1.6 times as often. Eyelid problems leading to hospitalization occurred more than twice as often. This is no joke. Draining, purulent eyelids appear to be a common consequence of anthrax vaccination, and the reason is obscure. Optic neuropathy leading to hospitalization occurred nearly 3 times as often after vaccination. This condition is usually autoimmune, and many cases later develop into multiple sclerosis.

Dermatophytosis is a fungal skin infection. It resulted in hospitalizations nearly 5 times as often after vaccination. Is this a consequence of impaired immunity to fungal infection?

Some illnesses made the list because they simply occur more often during deployments, like malaria, cholera and typhoid. Anthrax vaccinations are required for soldiers who deploy, but not required for other troops. Others illnesses may be miscoded. Many males have reported testicular inflammation after anthrax vaccine, which may lead to low testosterone levels, loss of interest in sex, and difficulties conceiving. (I have evaluated a number of males with this problem.) Perhaps some of these cases were miscoded as hydrocele, which is associated with fluid on the testis but is not due to acute inflammation.

Look at the second table: there are a list of cancers that caused hospitalizations more often after anthrax vaccine. Female uterine cancer hospitalizations were more than 4 times more common after vaccination. Gallbladder and bile duct cancer hospitalizations were nearly 3 times as common.

Blood clots seem to be related to vaccination. Both hospitalizations for portal vein thrombosis and "acute pulmonary heart disease" (pulmonary embolism) are more common. So are hospitalizations for varicose veins, and "injury of blood vessels of upper extremity" which may represent miscoded episodes of deep vein thrombosis.

Here are additional Tables from the Army Medical Surveillance Activity on illnesses pre and post-vaccination.

Anthrax vaccine seems to cause very unusual illnesses and patterns of symptoms that cannot be found in medical textbooks. This might be why nonspecific diagnostic codes are used more often in hospitalizations after vaccination, such as: "other disorders of stomach and duodenum," "other disorders of the respiratory system," "ill-defined descriptions of heart disease," "symptoms involving nervous and musculoskeletal," "other nonspecific abnormal findings," and "complications of medical care, not elsewhere classified." These diagnoses need to be sorted out, so we can discover precisely what kinds of complex illnesses are due to the vaccine.

It is also important to note that, overall, vaccinated soldiers did not have more hospitalizations than unvaccinated troops, or than they did prior to vaccination. Thus it appears there are specific diagnoses, or clusters or symptoms, that vaccinated troops develop at relatively high rates, which unvaccinated troops develop at much lower rates. However, because there seem to be dozens of these diagnoses, rather than just one or two, it has been harder to pin the relationships down. Compounding this difficulty is the military's failure to release hospitalization and outpatient data since 2001.

Here is the way these data were presented in the 2002 IOM report on anthrax vaccine. Each URL represents one page in the report. To get a printable pdf version, click on "printable pdf page" next to the page number:

http://books.nap.edu/openbook.php?record_id=10310&page=246

http://books.nap.edu/openbook.php?record_id=10310&page=247

http://books.nap.edu/openbook.php?record_id=10310&page=248

http://books.nap.edu/openbook.php?record_id=10310&page=249

http://books.nap.edu/openbook.php?record_id=10310&page=250

http://books.nap.edu/openbook.php?record_id=10310&page=251

An HHS-DOD "Anthrax Vaccine Expert Committee" examined 1841 VAERS reports for the government, which had been reported to FDA between 1998 and 2001. This committee found that there was one report for every 282 vaccine recipients. Again, women were disproportionately represented, reporting three times as often as would be expected if there were no gender difference. Flu-like symptoms and rashes often tended to recur with subsequent doses. The Committee's report can be found here. Over 5200 people have now filed VAERS reports for anthrax vaccine.

---

http://anthraxvaccine.blogspot.com/

Evidence anthrax vaccine causes heart attacks

Many (young) soldiers have had heart attacks after anthrax vaccinations. Could the two be related? The Army Medical Surveillance Activity (AMSA) compiled data on over 300,000 recipients of anthrax vaccine, and looked at their rates of heart attacks before and after anthrax vaccinations. This data was shared with the Institute of Medicine in 2001 at its request, and therefore became available to the public. Since then, this data (the Defense Medical Surveillance System) has been hidden from the public.

The rate of heart attacks (a.k.a. acute myocardial infarctions) was twice as high after anthrax vaccination [9.2 vs. 4.6 events per 100,000 persons/year]. Two related disorders, coded as "other acute and subacute form of ischemic heart disease" and "other forms of chronic ischemic heart disease" were more than twice as common after anthrax vaccination as before [18.8 vs. 7.1 total]. Click here to see the raw data.

Armed Forces Epidemiology Board Acknowledged Lack of Consensus Regarding Anthrax Vaccine Program's Risk-Benefit--click here

Medical Associations Investigate Anthrax Vaccine Trial that Sickened Dozens of Soldiers http://www.haaretz.com/hasen/spages/863699.html This is an update on the Israeli vaccine injury situation. The Israeli Medical Association's ethics bureau will investigate whether "volunteer" soldiers were actually given proper informed consent, guaranteed the most minimum risk as a result of their volunteer participation, and otherwise treated ethically as specified by the Helsinki Declaration. The Physicians for Humans Rights organization will also be investigating. Wouldn't it be wonderful if their US counterparts took the same initiative? Meryl

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

Last update - 01:15 28/05/2007 Secret IDF anthrax vaccine trial on soldiers to be investigated By Yuval Azulai, Haaretz Correspondent The Israel Defense Forces will provide the ethics bureau of the Israeli Medical Association with all the details of secret experimental anthrax vaccine trials it carried out on over 800 soldiers since 1999. A committee will be established to probe whether the trials adhered to World Medical Association ethical requirements relating to human clinical trials as set out in the Helsinki Declaration. The IMA probe will comprise specialists in infectious diseases, and members of the Israeli delegation to the Helsinki committee which devised the international standards for clinical trials on humans. Chairman of the IMA Ethics Bureau, Professor Avinoam Reches, said on Sunday that the probe's findings will be made public. The Israel Medical Corps requested that the IMA investigate the experiments after Channel 2 television's current affairs program, Uvda, revealed earlier this month that dozens of participants still suffered unexplained medical symptoms. Following the expose, the Defense Ministry and former IDF chief medical officer issued statements saying the experiment had been carried out because Iraq was expected to use spores of the deadly anthrax bacteria to attack Israel. Israel did not possess sufficient quantities of the vaccine to field such an attack, and was therefore compelled to produce the vaccine rather than importing it. Years after the receiving the experimental Israeli vaccine, soldiers continued to suffer unexplained skin tumors, severe lung infections, serious migraine headaches, bronchitis and even epilepsy symptoms. However, the IDF did not take responsibility for their ongoing treatment at civilian medical centers, and they were not allowed to discuss the experiment under any circumstances despite its likely connection to their continuing health problems. One of the soldiers who took part in the experiment told Uvda "They said that one group would receive the American vaccine, and the other group would receive the experimental Israel vaccine." "They specifically explained to us that the vaccine is not dangerous and that we were not being injected with the actual virus, not even the dead virus. Instead, they said they would inject us with the altered DNA of the virus. They said it was very advanced," added the soldier. The Ethics Bureau investigation committee will hear testimonies from Israel Medical Corps staff responsible for carrying out the secret experiments, as well as from soldiers who received the vaccine. Israeli non-profit group Physicians for Human Rights has requested the soldiers' testimonies as well, in order to pressure the authorities to create an independent probe commission into the medical practices of the IDF and Defense Ministry.

Women are Inordinately Harmed by Anthrax Vaccine

There is consensus regarding the fact that women have 2 to 3 times the rate of adverse reactions as men. Every study that has looked into this issue has found the same thing. The following four studies were done by 3 groups of different military researchers, and the last by CDC researchers: because Congress has asked that the role of gender be investigated with respect to adverse effects of the anthrax vaccine. The studies whose abstracts are listed below are all published since 2001, and are peer-reviewed articles in the medical literature. Two authors say this finding needs more study. Two authors say that the acute adverse reactions all resolved. However, if you read the complete studies, you will find that long-term active surveillance (by medical professionals asking questions or performing exams on study subjects) was not conducted in any of the studies, and the evidence that all reactions resolved is tenuous at best. Women also have more autoimmune disorders, in general, than men do.

1. Vaccine. 2001 Dec 12;20(5-6):972-8.
Anthrax vaccine: short-term safety experience in humans.

* Pittman PR,
* Gibbs PH,
* Cannon TL,
* Friedlander AM.

Division of Medicine, US Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5011, USA. phillip.pittman@det.amedd.army.mil

Bacillus anthracis is the major terrorist and biological warfare agent of concern to civilian and military medical planners. The licensed anthrax vaccine, adsorbed (AVA) is believed to be an effective prophylactic medical countermeasure against this threat. Our objective in this report was to expand the safety database for this vaccine by assessing data on self-reported, short-term safety of AVA during more than 25 years of use, measured by local and systemic adverse events temporally associated with the administration of AVA. A minority of AVA recipients reported systemic and injection site reactions. Females reported a higher incidence of injection site and systemic adverse events than males. Data show a difference in incidence of local reactions between lots. A prospective, randomized, placebo-controlled study to actively examine reactogenicity is needed to more completely define the extent and nature of reactions associated with receipt of AVA in humans as well as to confirm the gender lot differences in local reaction rates.

2. J Occup Environ Med. 2003 Mar;45(3):222-33.
Analysis of adverse events after anthrax immunization in US Army medical personnel.

* Wasserman GM,
* Grabenstein JD,
* Pittman PR,
* Rubertone MV,
* Gibbs PP,
* Wang LZ,
* Golder LG.

Preventive Medicine Department, Tripler Army Medical Center, Honolulu, Hawaii, USA. glenn.wasserman@amedd.army.mil

A broad range of health effects in a cohort of 601 health care personnel, immunized with anthrax vaccine adsorbed (AVA) as a military occupational health requirement, were assessed to evaluate adverse events both qualitatively and quantitatively. Active surveillance showed that localized reactions were common and occurred more often in women than men. Five patients were reported to the Vaccine Adverse Event Reporting System, but only one event could be definitively attributed to immunization, a large localized reaction. Two separate cohort studies, one using nested data from a standardized health risk appraisal instrument and the other comparing rates of outpatient visits and hospitalizations, did not reveal significant differences between AVA-immunized and unimmunized individuals. Our findings suggest that AVA is relatively reactogenic but do not indicate serious adverse health effects due to immunization.

3. Vaccine. 2003 Oct 1;21(27-30):4399-409.
Using a structured medical note for determining the safety profile of anthrax vaccine for US soldiers in Korea.

* Hoffman K,
* Costello C,
* Menich M,
* Grabenstein JD,
* Engler RJ.

Military and Veterans Health Coordinating Board, 20420-0002, Washington, DC 20420-0002, USA. khoffman100@comcast.net

Selected military personnel are immunized with an FDA-licensed anthrax vaccine unless there are clinical contraindications. The objective of this analysis is to capture the experience of soldiers receiving anthrax vaccine to assist in better patient-provider communication and clarify the safety profile of the vaccine in this population as a quality-assurance initiative. Between August 1998 and July 1999, 2824 soldiers immunized against anthrax at one military clinic completed a structured medical note that was reviewed by a clinician. Female gender, prior vaccine-associated adverse events, and medication use were significantly related to higher reports of adverse events. All reported immediate consequences resolved.


4. Pharmacoepidemiol Drug Saf. 2007 Mar;16(3):259-74.
Short-term reactogenicity and gender effect of anthrax vaccine: analysis of a 1967-1972 study and review of the 1955-2005 medical literature.

* McNeil MM,
* Chiang IS,
* Wheeling JT,
* Zhang Y.

Anthrax Vaccine Safety Team, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. mmm2@cdc.gov

PURPOSE: In the 1960s, the Centers for Disease Control and Prevention (CDC) held the investigational new drug (IND) application for the anthrax vaccine and collected short-term safety data from approximately 16,000 doses administered to almost 7000 individuals. While some recent anthrax vaccine safety studies have suggested that women experience more injection site reactions (ISRs), to our knowledge the IND safety data were not previously examined for a gender-specific difference. METHODS: We identified and analyzed a subset of the IND study data representing a total of 1749 persons who received 3592 doses from 1967 to 1972. Original data collection forms were located and information extracted, including: vaccine recipient's name, age at vaccination, gender, dose number, date of vaccination, lot number, grading of ISR, presence and type of systemic reactions. Overall and gender-specific rates for adverse reactions to anthrax vaccine were calculated and we performed a multivariable analysis. RESULTS: We found an ISR was associated with 28% of anthrax vaccine doses; however, 87% of these were considered mild. Systemic reactions were uncommon (<1%) and most (70%) accompanied an ISR. Our dose-specific analysis by gender found women had at least twice the risk of having a vaccine reaction compared to men. Our age-adjusted relative risk for ISR in women compared to men was 2.78 (95%CI: 2.29, 3.38). CONCLUSIONS: Our results for both overall and gender-specific reactogenicity are consistent with other anthrax safety studies. To date, possible implications of these gender differences observed for anthrax and other vaccines are unknown and deserve further study.

Soldiers from every other country that used anthrax vaccine have had medical problems, although information is limited

Meryl Nass, MD

May 26, 2007

Israel

Dozens of Israeli soldiers who volunteered to take part in classified anthrax vaccine experiments years ago are reportedly still ill as a result, according to Israeli media. Here’s the article:

United Kingdom

British authorities have claimed that 50% of troops accepted the vaccine voluntarily.¹ But in one study of voluntary vaccinations, only 21% of the soldiers offered vaccinations completed the four dose series.² The authors concluded, “Although the old vaccine is considered safe, the number of adverse reactions and incapacity reported by a military medical unit was unexpected.” Another study at five Royal Air Force bases found that only 4 to 22 per cent of those volunteering for anthrax vaccinations chose to complete all four doses.³

A study of veterans and Gulf War illness symptoms found that soldiers who received anthrax vaccine for the Gulf War were 1.5 times as likely to report chronic Gulf War illness as those who did not, and that those who received anthrax vaccine for the Bosnia deployment were over 3 times as likely to report a similar chronic illness.⁴

Some British troops believe anthrax vaccine contributed to birth defects in offspring:

http://www.medicalnewstoday.com/medicalnews.php?newsid=6281

“Anthrax vaccine inquiry soldiers demand

02 Mar 2004 - 0:00 PDT

UK soldiers have asked for an inquiry into anthrax vaccines after several babies were born with defects.

Spokesman for the National Gulf Veterans and Families Association Charles Plumridge said he had received a number of calls 'from mothers and husbands whose wives are now pregnant and are worried their babies may be born with some form of defect'.

The association has written to British Prime Minister Tony Blair demanding a public inquiry into vaccinations given to soldiers before the US-led war in Iraq was launched last March.

According to the group, since the war, pregnant women treated at the 33rd Military Field Hospital in Gosport, southern England, have suffered two miscarriages, three premature births, one still birth and a forced termination because a foetus was not developing properly.

In each of the seven cases, at least one of the parents received a vaccination against anthrax.

In some of the cases, babies suffered limb defects or skin problems, according to the association.

A spokeswoman for Britain's Ministry of Defence said the anthrax vaccinations were voluntary.

'Congenital disabilities are unfortunately common, affecting about one in 33 live births', said the spokeswoman.

She added that a number of studies had shown a high rate of congenital disabilities in children of veterans of the 1991 Gulf War, but that these studies were not connected to vaccination programs.”

Canada

Canada’s Department of National Defense hired contractor Goss-Gilroy Inc. to study risk factors and Gulf War Illnesses.⁵ The 1998 study found that soldiers who had received anthrax and / or plague vaccinations during the first Gulf War deployment were 1.92 times as likely to suffer from chronic fatigue as those who did not receive these biological warfare vaccines.

In 2000, a decision by military judge Guy Brais ended Canada’s mandatory anthrax vaccination program. His ruling stated,

“It was sufficient and the court is satisfied on the balance of probabilities that the defense has successfully demonstrated that the anthrax vaccine contained in lot 020 was unsafe and hazardous and could be responsible for the important symptoms reported by so many persons who received that vaccine…

In those circumstances, the court concludes that the accused's right to life, liberty and security of the person in section 7 of the Charter of Rights and Freedoms were infringed. And as the court stated earlier, the government, through its Department of National Defense and the Canadian Forces, could never be justified to impose inoculation of soldiers with an unsafe and dangerous vaccine as a limit of their rights under section 7.” ⁶

Since the Afghanistan war began in 2002, Canadian troops have not even been offered voluntary anthrax vaccinations: ⁷

http://cnews.canoe.ca/CNEWS/War_Terror/2007/03/05/3699886-cp.html

March 5, 2007

No anthrax vaccine for Afghanistan troops: DND

By DENE MOORE

MONTREAL (CP) - Canadian military officials say they're not considering a mandatory anthrax vaccination campaign even though the U.S. military has made the controversial inoculation mandatory for its soldiers serving in Afghanistan.

As of April 30, all U.S. soldiers heading to Afghanistan will have to be immunized against anthrax.

The U.S. Department of Defence has announced that all branches of its military will have to inoculate service members heading to high threat areas, including Iraq, Afghanistan and the Korean Peninsula.

But Gloria Kelly, spokeswoman for the Canadian Forces health services group, said Monday that the Department of National Defence is not considering the same.

"At this point in time, we are not requiring our people to have anthrax vaccinations nor are we considering it," Kelly said from Ottawa.

Both the Canadian and U.S. militaries ceased mandatory anthrax immunizations after questions arose about the safety and efficacy of the vaccine.

The U.S. army continued to offer a voluntary vaccination but only about half of U.S. soldiers signed on.

The U.S. Food and Drug Administration has since declared the anthrax vaccine safe and effective, opening the door to the mandatory program south of the border.

"The anthrax vaccine will protect our troops from another threat - a disease that will kill, caused by a bacteria that already has been used as a weapon in America, and that terrorists openly discuss," Dr. William Winkenwerder Jr., assistant secretary of defence for health affairs, said in a U.S. defence department statement announcing the program.

"The threat environment and the unpredictable nature of terrorism make it necessary to include biological warfare defence as part of our force protection measures."

In little more than six weeks, all U.S. soldiers heading to Afghanistan will have to be immunized against anthrax, a bacterial infection that commonly occurs in domesticated animals.

Anthrax has not been used in combat but five people died and 17 were sickened when anthrax spores were sent through the U.S. mail in the wake of the Sept. 11, 2001, terrorist attacks.

Dr. Ron Wojtyk, of Canadian Forces health services, said the threat of anthrax exposure in Afghanistan is not sufficient enough to make the vaccine mandatory.

Wojtyk said the U.S. is deployed in areas where the threat is more pressing, such as Iraq.

"If we deploy to an area where there is a threat of anthrax or possible release on a bioterrorist type of scenario, then there would be an order for anthrax and it would be mandatory," Wojtyk said Monday.

Canada has about 2,500 troops in southern Afghanistan as part of NATO's International Security Assistance Force.

During the 1991 Gulf War western troops were immunized against anthrax.

The Canadian military received special permission from Health Canada to use the vaccine developed for the U.S. Department of Defence, although it was not approved for use by the general public.

Despite concerns about the manufacturer and possible adverse side effects, in the spring of 1998, on the heels of a similar directive within the U.S. military, the Canadian Forces made the anthrax immunization mandatory for troops serving in Kuwait. Many soldiers refused the inoculation, citing concerns of a link with so-called Gulf War syndrome. Canada later discontinued the vaccination.

The U.S. Department of Defence, at the behest of a U.S. district court, discontinued in October 2004.

Australia

Nearly three quarters of soldiers vaccinated prior to deployment to Afghanistan suffered severe acute reactions, according to Australian defense documents released in early 2004.⁸ Yet, asked on TV about the safety of the anthrax vaccine, Australian Minister of Defense Robert Hill had claimed two months earlier that, “there hasn't been any adverse reactions, let alone extreme reactions.” ⁹

No reports of the vaccinated soldiers’ subsequent health status have been provided to the public.

“The Australian Medical Association has called upon the military to prove the vaccination is safe. ‘If they have that data, the medical profession in Australia would very much like to see it,’ the Association's president Kerryn Phelps told Australian Broadcasting Corporation radio.” ¹⁰

http://www.medicalnewstoday.com/medicalnews.php?newsid=6063

"Anthrax vaccine serious side-effects kept from soldiers who were vaccinated

21 Feb 2004 - 0:00

Australian authorities vaccinated all its soldiers against anthrax before they went to Iraq. What it did not do, however, was to tell them that most of its soldiers who returned from Afghanistan previously, got ill from taking the same vaccine.

Thank God the soldiers sent to Iraq did not have the unusual side effects the previous soldiers had had.

Most of the Australian troops sent to Afghanistan in 2001 became ill, said the Australian government.

Officials are saying they did not tell the soldiers bond for Iraq because they did not want to make them anxious. They also said that they did not expect the soldiers this time round to suffer any side-effects.

75% of the soldiers sent to Afghanistan became ill as a result of taking the Anthrax vaccine. Confidential papers were released to an Australian newspaper under Freedom-of-Information Rules.

The soldiers experienced swelling, a high level of pain and flu-like symptoms as well. They never found out what caused the side-effects, suspended the vaccination programme for several weeks and then resumed it.

Australian military doctors have suggested that other factors could have contributed to the side-effects felt in Afghanistan. The soldiers were working at constantly changing altitudes, they had high physical workloads and the temperatures fluctuated a great deal.

In 2003, the authorities still went ahead and vaccinated all their troops sent to Iraq, even though they knew what had happened to their troops who had taken this vaccine before. The authorities did not even know what had caused the side-effects.

In order to demonstrate faith in the vaccine, Robert Hill, Australia's Defence Minister, vaccinated himself just before the troops were sent to Iraq.

About 40 service people were sent back from Iraq because they refused to be jabbed (vaccinated). They have not been disciplined.

So far, no unusual side-effects have been reported since the troops came back from Iraq.

'We were in a position where all we would have been able to tell them was that there had been a problem,' Air Commodore Tony Austin told reporters.

'We had not been able to identify a cause from that and we had absolutely no evidence to suggest that we were likely to see that again, based on overseas experience and our own experience when we reinstituted the programme in Iraq. So, I think to have advised people of that would have been quite counterproductive. I think that would have increased anxiety levels amongst our people.'

Opposition party defence spokesman, Chris Evans said 'The defence department hasn't been honest with the troops, hasn't been honest with the parliament, and the minister needs to provide answers as to what's gone on here."

France

France did not vaccinate its troops for the first Gulf War, and has a low incidence of Gulf War illness in its veterans. An interesting, but brief, article was published by Reuters about this in 2000 but there was never any follow-up. Go to the next page for the article:

1 http://news.bbc.co.uk/1/hi/uk_politics/2749735.stm

2 Hayes SC and World MJ. Adverse reactions to anthrax immunisation in a military field hospital. J Royal Army Med Corps. 2000 Oct;146(3):191-5.

3 Enstone JE, Wale MCJ, Nguyen-Van-Tam JS et al. Adverse medical events in British service personnel following anthrax vaccination. Vaccine 2003; 21:1348-54.

4 Unwin C, Blatchley N, Coker W et al. Health of UK servicemen who served in Persian Gulf War. Lancet 1999: 353: 169.

5 This study was posted on the Canadian Department of National Defense website from 1998 for several years but is no longer online. The study has not been published. This author has a copy, obtained via download.

6 http://www.mvrd.org/AVN/sonnie/law%5Ccanadatranscript.htm#judge

7 http://www.cbc.ca/cp/health/070305/x030519A.html

8 http://www.usatoday.com/news/world/2004-02-21-australia-anthrax_x.htm

9 http://www.abc.net.au/lateline/stories/s783068.htm

10 http://www.abc.net.au/news/newsitems/200408/s1175466.htm