August 30, 2005

Army Proposal to use U.S. Soldiers as Human Test Subjects

M. Alexander Otto
Bureau of National

The U.S. Department of Defense (DoD and the Federal Drug Administration (FDA) are facing a tough lawsuit by soldiers questioning the safety of the experimental anthrax vaccine. In response, DoD and FDA want a new drug category and bypass human test subject rules. This plan by DoD and FDA represents a major attempt to undermine the health and safety rights of soldiers. Congress must stop the DoD and FDA plan. We urge readers to familiarize themselves with the Nuremberg Code that prohibits using humans as experimental test subjects unless there is informed consent and the right to refuse.

Human Subject Protection

Army Researchers' Plan Seeks Exemption From FDA Experimental Product Safety Rules Under a plan proposed by U.S. Army human research regulators, the Department of Defense could ignore key Food and Drug Administration safety standards when administering experimental products to soldiers, according to an October memorandum recently obtained by BNA from the U.S. Army Medical Research Institute of Infectious Diseases' Office of Human Use and Ethics. Under current FDA rules, experimental drugs and devices only can be used in well-controlled clinical trials that test safety and efficacy. That means the principal investigator must supervise the administration of the product and serious side effects must be reported to FDA within seven days, neither of which are practical in combat situations, according to the memorandum, dated Oct. 11, 2002.

Investigational products also must carry labels that state "Caution: New Drug-Limited by Federal (or United States) Law to Investigational Use." "This label can lead the war fighter to question the safety and/or effectiveness of the product and may threaten operational objectives," according to the memo.

New FDA Category

The plan would exempt the military from the clinical trial requirement. Instead, a joint military and FDA panel would review the safety and efficacy of the agent, determine whether a clinical trial is feasible, identify ethical obligations, and approve the product under a new FDA category: "licensed for contingency."

The category would be reserved for "products unlikely to receive FDA approval under current rules but that have sufficient human safety and animal efficacy experience to permit military use." The memo noted, however, that the military often fields products that have not been tested in humans "because of the great danger to individuals of conducting human clinical efficacy trials." "DoD should continue to conduct trials when ethically appropriate and when time and resources permit compliance with the [Federal] Food, Drug and Cosmetic Act," the five-page memo stated.

Some of the content for this position paper was added to the DOD Medical Department legislative agenda, Dr. Arthur O. Anderson told BNA. Anderson is chief of the USARMIID Office of Human Use and Ethics and Department of Clinical Pathology. He co-authored the memo with Chris Beardmore, an administrator in the Office of Human Use and Ethics.

Advocate Skeptical

The move would resolve ongoing conflict with FDA about the use of experimental products. Following the Gulf War and action in Bosnia, DOD was criticized for failing to report adverse events, properly label and track investigational products, and ask soldiers' permission before administering experimental agents. Dr. Meryl Nass, an advocate for soldiers injured by anthrax vaccine, botulinum toxin, nerve gas antidote, and other experimental products, takes a dim view of the initiative. It is part of an ongoing DOD campaign to free the military from basic human subject protections, she said. Soldiers are subject to military discipline if they refuse an experimental product. Those injured have no recourse; soldiers cannot sue DOD for injuries received while in the service, Nass noted.

Anthrax vaccine under fire Refusal rate concerns military; troops speak out

(originally posted on July 25, 2005)
The Star's Washington Correspondent

WASHINGTON -- Shonya McBride remembers very clearly the night sherolled over in her sleep and her hand fell across her husband's chest. She awoke with a start. "His heart was just pounding out of his chest," she said. That was in 1999, after Travis McBride, a 22-year-old Marine Corps sergeant, had received the second of six mandatory inoculations of the anthrax vaccine. By the fourth shot, he had developed serious heart problems, chronic fatigue and severe joint pain. McBride never made it to the fifth. Within a year, he was medically discharged. He had been ordered to take the shots, like probably hundreds of military men and women who believe the vaccine boomeranged and made them seriously ill. "If I had had the option, I wouldn't have taken it," said McBride, now 28 and an Atchison County sheriff's deputy.

For the past two months, however, incoming military personnel have had the option of not taking the anthrax vaccine, as a result of a federal lawsuit won last year by some military personnel who objected. For now, instead of being threatened with courts-martial and dishonorable discharges, soldiers are told the shots are voluntary. As a result, half of the military and civilian Defense personnel asked since May to take the shots have declined, according to the Pentagon. The refusal rate worries the military, which many believe would like to reinstate the mandatory rule for all active duty personnel and reserves. "That means that half of our (newest) troops could be harmed in an enemy attack and possibly die," said Marianne Coats, a spokeswoman for the Military Vaccine Agency. "This concerns us very much indeed. "Vaccine critics said the situation is an improvement. Mark Zaid, an attorney involved in the lawsuit, said that much progress has been made since the days of military courts-martial, but added that it remains subjective whether the vaccine being voluntary is a good thing. What concerns Zaid and other critics is that the anthrax information brochure that the military hands out contains none of the information that comes packaged with the vaccine about risks and medical reactions possibly linked to it. Beyond the more common nausea, fever and chills, other medical problems possibly linked to the vaccine, according to the manufacturer's insert, include multiple sclerosis, encephalitis, leukemia, blood clots, nervous system disorders, lymphoma and immune deficiencies.

"The Defense Department does not wish for troops to even know the dangers explained on the vaccine's own label," Zaid said. Col. John Grabenstein, director of the Military Vaccine Agency, said in an e-mail response to a series of questions that since 1998, the military has provided "detailed educational programs" to explain the anthrax vaccine. The Pentagon and the Food and Drug Administration insist that the vaccine, which has been given to about 1.3 million military and some civilian personnel since 1998, is safe and effective.

Citing a 2002 National Academy of Sciences study, Grabenstein said that the anthrax vaccine posed no greater risk of serious health problems than any other vaccine. But some former soldiers, outside experts, military activists and other supporters do not think that is accurate. Former Master Sgt. Dennis Brewster of Augusta, Kan., was diagnosed with an array of medical ailments after the shots, including chronic, widespread joint pain, chronic headaches, chronic fatigue and irritable bowel syndrome. "I knew how I was before the shot, and I got the shot and I know what happened to me," he said.

No informed consent

The anthrax vaccine has been controversial almost from the beginning. The FDA licensed it in 1970, but only for anthrax exposure through the skin because the disease was largely confined to the livestock industry. No human testing of its effectiveness had been done. The testing that was performed, in 1962, was on a different version of the vaccine. The manufacturing process had changed by 1970 when it was licensed. The vaccine was never approved to protect against anthrax inhalation, which is how troops would encounter the toxin on the battlefield and why the military forced soldiers to be vaccinated. Still, the Pentagon used it to vaccinate certain units against anthrax before the 1991 Gulf War because of fears that Iraq had biological weapons. Since then, researchers at Kansas State University have found a possible link between the vaccine and the series of mysterious maladies known as Gulf War Syndrome experienced by many veterans of that conflict. In 1997, as concern heightened about troops deployed to the Persian Gulf and Korean peninsula, the Pentagon made the vaccine mandatory. The regimen was a series of six doses over 18 months, with annual boosters. The threat of anthrax as a battlefield weapon is probably greater in North Korea than anywhere else, according to Jonathan Tucker, a chemical and biological weapons expert at the Center for Nonproliferation Studies at the Monterey Institute for International Studies. "I'm not familiar with any evidence that the (Iraq) insurgency or the Taliban has access to anthrax," he said. "North Korea is assessed to have a biological weapons program, and anthrax would probably be an agent in its arsenal. "Meanwhile, the sole manufacturer of the vaccine, the BioPort Corp. of Lansing, Mich., has been cited several times by the FDA for quality control problems. The military shut down the vaccine program last fall when a federal judge ruled in favor of six anonymous former and current Defense Department employees who alleged that the vaccine was being used in a way for which it had not been licensed and should not be forced on anyone. The government has appealed the ruling. In the meantime, the Pentagon began the voluntary inoculations in May under an emergency-use authority, citing a high bioterrorist threat.

`Blind eye' alleged

Six years after taking the vaccine, McBride's heart problems shadow his family's every move. When he takes his 5-year-old son fishing, he and his wife make sure the child remembers how to dial 911 in case his father has a problem. At the time, refusing the order to take the vaccine wasn't an option. He loved being a Marine and hoped to make a career out of it. "I was an enlisted serviceman," he said. "I was told to jump; you asked, `How high?' I was just doing what I was ordered." So was Army Sgt. Sandra Larson of Spokane, Wash. In 2000, three months after receiving her final shot while assigned to Fort Riley, Kan., she died of a rare blood disorder at the age of 32. "It was as if there was something in her that was killing her immune system, shutting her down," her sister, Nancy Rugo, told a congressional committee after her death. Between 1990 and 2004, 16 people died after taking the vaccine, according to the government's Vaccine Adverse Event Reporting System. Most suffered heart, lung and immune system problems, and cancer. All but five were dead within three months of their last vaccination. In addition, the reporting system shows that nearly 4,500 other recipients have had medical reactions, with nearly 8 percent listed as "serious," meaning the problems were life-threatening, required hospitalization or resulted in a major disability. The reports are submitted by vaccine recipients and providers, relatives, health-care givers and others, but are not necessarily inclusive of everyone who has had a reaction.

The Institute of Medicine, a division of the National Academy of Sciences, called the vaccine reporting data "useful as a sentinel for adverse events." But it cautioned that the reports might be "underreported, incomplete, or duplicative," and that the claims are not always verified by medical officials.G rabenstein said that anyone who becomes sick after avaccination "deserves the best care we can give them, whether a vaccine is the cause of their health problem or not. "But Meryl Nass, a Maine internist and leading critic of the vaccine,said the military had turned "a blind eye" to the risks. She has examined numerous vaccine recipients with serious illnesses, including several who served in the Kansas Air National Guard. "The people who become disabled more often than not have multiple diagnoses," Nass said. "They also, more often than not, have syndromes that are rare or nonexistent in the patients that doctors normally see. Their bodies are not doing what they're supposed to be doing."

Leaving the big B-1 behind

Worries began to seep through the military ranks within two years of the start of the vaccine inoculations. Pentagon reports show that between 2000 and 2004, 149 servicemembers refused the vaccine. Some were court-martialed for refusing an order and given bad conduct discharges. About a dozen cases are in stages of appeal. In a 2002 study, the General Accounting Office surveyed Air NationalGuard and Air Force Reserve aircrews and found that 16 percent of more than 800 airmen who responded had either transferred, become inactive or left the service between 1998 and 2000 to avoid the shots. An additional 18 percent said they planned to leave soon. The GAO, now known as the Government Accountability Office, also found that about 84 percent of the pilots and crew members who took the vaccine during that period experienced side effects or adverse reactions, a rate more than double what the manufacturer claimed at the time. In addition, the study found that about 24 percent of those reactions were systemic - meaning that they affected their entire bodies. That was "more than 100 times higher" than what the manufacturer estimated, the GAO said. The military ordered former Maj. David Towne, who flew for the 128th Bomb Squadron of the Kansas Air National Guard, to take the shot in 1999. Towne was torn because he loved flying the big B-1 bombers, but worried about developing health problems and jeopardizing his civilian career as a commercial pilot. "I wear a bicycle helmet, I wear my seat belt. I just decided it was not worth it for me to take it," he said. "They told me I was unpatriotic and would regret this for the rest of my life. They questioned my integrity." Towne, who is 39 and now lives in Ohio, offered to resign but received a general discharge instead. He has appealed. "These are people who volunteer their lives and livelihood to protect America," said Peter Martuscello of Wichita, a 57-year old former Kansas Air National Guard technical sergeant who was medically discharged after taking the vaccine. He developed Guillain-Barre Syndrome, an immune disorder, and other problems. "To dump on people like that is crazy," Martuscello said. "That's the sad part. They gave you no option." And no information on possible risks, according to several former soldiers who took the vaccine and became ill. Brewster said that when his unit in the 184th Bomb Wing of the Kansas Air National Guard got a briefing about the vaccine in June 1999, "They didn't tell us about any risk. They gave us the basic standard speech," he said. "They said there was some talk out there, but it was all Internet hype." A week after receiving the first shot, Brewster started feeling like he had the flu. Then a powerful fatigue came over him. His ankles, knees, shoulders, elbows and hands all began to hurt. He also got severe headaches. By the fourth shot, his health had further deteriorated. He was in and out of the hospital for intestinal surgery and heart problems. He also became hyperallergic. Brewster retired in 2001 under honorable conditions after 23 years of service. He has a one-man home remodeling business that allows him to take time off when he's feeling badly and runs out of energy. He sleeps a lot. "A lot of the guys hid the illness and still are," said Brewster, who had been a full-time civilian employee of the Guard, in addition to his military service. "Had I not ended up in the hospital, I probably would have tried to hide mine." The anthrax vaccine, he said, "cost me my career."

Anthrax timeline

1970: FDA approves vaccine for skin exposure

1991: Military gives vaccine to some troops in the first Gulf War

1997: Pentagon orders vaccine mandatory for all military personnel

1998: Congress passes law requiring informed consent if troops are given drugs unapproved for their intended use

1998-99: FDA finds quality-control problems at vaccine plant

2000: Sgt. Sandra Larson takes final anthrax shot at Fort Riley, Kan. Larson dies three months later.

2000: Institute of Medicine concludes vaccine is safe

2000: Federal judge stops mandatory shots.

2005: Voluntary vaccine program begins.

National Institutes of Health Decision Delayed on Anthrax Vaccine Testing on Children

(originally posted on July 08, 2005)
By David Ruppe
Global Security Newswire

WASHINGTON - A plan to conduct safety tests of two experimental anthrax vaccines on children could proceed, despite the recent removal of any reference to such testing from a notice on the National Institutes of Health Web site (see GSN, June 27).Researchers from the National Institute for Child and Human Development(NICHD) last year proposed including 100 first- and second-graders along with 350 adults in a clinical study assessing the relative safety, safe dosage levels, and side effects of a currently used vaccine and a new one for protection against inhalation anthrax.

A NICHD review board approved the study in July 2004, but directed that a decision on whether to include children be deferred until after the adults, ages 18-30, were tested and the results assessed .The study formally began Sept. 8, 2004 and its completion is dependent, in part , upon recruiting volunteers. As of last week, 52 adult patients had been vaccinated using either the focal point of the testing, a genetically engineered anthrax vaccine now under development by NIH, or the controversial Anthrax Vaccine Adsorbed, which is now administered to U.S. military personnel deployed to certain regions of concern (see GSN, July 7).The National Institutes of Health has published advertisements seeking participants for the trials in the Washington, D.C. area, offering compensation totaling $400 for eight clinical visits over the course of a year .Compensation is not unusual and typically covers expenses and time, said Dr. Stephen Kaler, clinical director of the NICHD intramural research program .The institute would obtain parental consent for children to participate, if that component of the study is approved, he said .Web Site Notice Changed Complaints have surfaced in recent weeks that the trial, at least initially ,should not include children and that no children should be vaccinated with the older vaccine because of doubts about its safety ."I have grave concern about any intent to proceed with clinical trials with children at this point," Senator Jeff Bingaman (D-N.M.) wrote in a July 1letter to Health and Human Services Secretary Mike Leavitt ."Surely considerable information regarding the safety of the new vaccine, as well as about its potential effectiveness, should be obtained in adults long before any consideration is given to providing it to children. And, based on what already is known about the adverse event profile of the older vaccine ,it should not be 'tested' in children at all," he added .Critics have also expressed their doubts in U.S. newspapers ."There is almost no risk to these children of being exposed to a form of .anthrax that has been weaponized," Barbara Loe Fisher of the National Vaccine Information Center told the Kansas City Star. "The benefits are zero and the risk is quite high ."A notice published in 2004 by the NIH Patient Recruitment and Public Liaison Office, which said the trial planned to include 100 children, prompted the criticisms. The institute recently removed that statement from the notice .Kaler said there was a misunderstanding that children were already part of the trial. He said an additional decision by the Institutional Review Board ,following the outcome of testing on adults, would be needed before children might be included .Whether children would ultimately be included is an "open question, because it hasn't been approved," he said Kaler said some view a perceived benefit from testing the new vaccine on children ."Whether we do this in children is tempered by the feeling of some that children would be at risk in a bioterrorism attack and it would be unfortunate if children weren't included in the study," he said .Safety Questions There are uncertainties about the safety of both vaccines .This trial phase is the first human testing for the NIH vaccine, which is still under development, according to Kaler. If the vaccine passes, it could then be subjected to two additional phases of trials involving larger numbers of patients, according to Food and Drug Administration regulations. One phase would evaluate its effectiveness and further evaluate its safety, and the second would seek to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that would allow the drug or treatment to be used safely, according to the regulations. After that, the Food and Drug Administration could determine whether to license the vaccine as safe and effective against inhalation anthrax, the method of contraction of foremost concern from bio warfare or terrorism. The entire process apparently could take years. The NIH vaccine is distinct from another genetically engineered anthrax vaccine, under development by the company VaxGen. The Health and Human Services Department in November purchased 75 million doses of that vaccine for $878 million, enough to vaccinate 25 million people against inhalation anthrax, according to the company (see GSN, May 6). The department also awarded the company up to $69 million for, among other things, testing on children and the elderly after the Food and Drug Administration has approved the vaccine, according to Vice President of Public Affairs Paul Laland. The VaxGen vaccine is in its second phase of testing. The older Anthrax Vaccine Adsorbed was licensed in 1970 as safe and effective against anthrax contracted through the skin, the disease form likely to infect textile and farm workers, and veterinarians. The Food and Drug Administration has not yet licensed it effective against inhalation anthrax. Questions recur about its safety, with rare reports of debilitating reactions after vaccination and experts questioning whether there is a link to multisymptom illnesses effecting soldiers after the first Gulf War (see GSN, Nov. 16. 2004).The Defense Department insists the vaccine is as safe as other commonly used vaccines, or safer. "Study after study shows: people vaccinated against anthrax are as healthy as unvaccinated people," according to a statement on the DOD Web site .It is uncertain how many military and civilian personnel have experienced severe reactions from the existing vaccine. However, of approximately 1.3million personnel vaccinated against anthrax during 2003 and 2004, hundreds were said to have been treated for "complex" cases following those and other vaccinations at four special vaccine treatment clinics, ranging from muscle and joint weakness and pain to multiple sclerosis (see GSN, May 6).The military since May has been administering the vaccine to select military personnel on a voluntary basis, after a judge found that the treatment could not be required because the Food and Drug Administration had not yet properly licensed it against inhalation anthrax. About half the civilian and military personnel offered the vaccine have refused the shot. A Food and Drug Administration review for that license is under way, which could allow mandatory vaccinations to resume .The new vaccine however should be safer, according to an NIH advertisement for trial volunteers, provided by Kaler ."The vaccine is expected to be as effective as the licensed anthrax vaccine(AVA) but it is purer and should be safer," it says.

August 28, 2005

The Missing Link: FDA Memo, anthrax vaccine

Project on Government Oversight
by Nick Schwellenbach

Yesterday POGO learned that the Food and Drug Administration (FDA) pulled down a link to a FDA memo on adverse effects from the military's anthrax vaccine. The memo is still there, it's just very hard to find now.

Marguerite Armistead, president of Protecting Our Guardians, a group of National Guard spouses critical of the anthrax vaccine, discovered the change. Originally this page contained a link to the memo. According to Armistead, after a lengthy piece by David Goldstein in the Kansas City Star (registration req'd) referenced the memo which lists 16 reported deaths after injection of the vaccine from 1990 to 2004 (note: this doesn't necessarily mean the deaths were caused by the vaccine), the page which had the link to the memo was taken down. The article appeared on July 25, 2005. Prior to the article, only 11 reported deaths were publicly known to have
occurred after injection of the vaccine.

POGO was able to find an archived version of the page which was found via Google's cache feature. Also, the Office of the Secretary of Defense's (OSD) anthrax vaccine website contains a link to the same report on that website. Just in case, POGO has in turn also saved the cached page and the FDA memo.

Since May, half of the military and civilian personnel at the Department of Defense offered the vaccine have refused it under the current voluntary program, Global Security Newswire reported this summer.

This memo which was taken off the FDA site, can be found here:

It is also downloaded should it be removed from DoD's site. Note the 16 deaths, and the adverse events which follow. This begins on page 6, ends on page 10.

Potentially Fatal Shot Comes From Syringe, Not a Rifle

By Helen Barrett

Kent Stewart prepares to report to Ft. Sill for active duty. He had a choice. Take the anthrax vaccine as ordered by his commanders or face Court Martial.

Despite reservations, E-4 Kent Stewart of the Oklahoma National Guard, HHB 45th, Field Artillery Brigade rolled up his sleeve and obeyed.

"I felt the shots weren't going to be doing any good," he said. "I didn't personally think there was that big a threat."

Stewart and the rest of his company received their activation orders February 14, 2003.

Five days later the first of a series of six vaccinations including the anthrax and smallpox vaccines started the unit's preparation for deployment to Iraq for Operation Iraqi Freedom.

Stewart had heard rumors of adverse reactions to the vaccines resulting in a reluctance to take the shots.

To refuse would result in a dishonorable discharge or a bad conduct dismissal his superiors told him.

Almost immediately after taking the first round of vaccines, Stewart began experiencing severe headaches.

On March 15 he received the second series of shots. The third series followed April 4.

Dizziness, tingling on the left side of his face, in his hands and legs, and attitude changes manifested themselves.

On May 27, ready to board the train for deployment from Ft. Sill in Lawton, the unit received notice their orders had been canceled.

Stewart received his fourth round of the vaccine on December 7, 2003.

Vomiting, weight loss, insomnia, and other symptoms started.

During the summer of 2004, Stewart suffered a pancreatic attack. Tests to determine his problem began. Each episode required treatment with antibiotics and other medications to ease the symptoms.

On Aug. 15, 2004, he received his fifth (and last) immunization.

His condition worsened until he was hospitalized Nov. 22, and placed on intravenous antibiotics for a week. Two days after his release the condition returned. His family physician referred him to Dr. Dilling, an ear-nose-throat specialist in Enid.

Realizing this was not a problem involving his speciality, Dr. Dilling referred Stewart to Dr. Rietz, a neurologist.

A battery of tests including a lumbar puncture, MRI, and extensive blood tests were performed. After obtaining the results, Reitz referred Stewart to Dr. Tarek Neguib, M.D. who specializes in immunology.

More tests followed.

In his official report dated March 28 of this year, Dr. Naguib listed his medical impression as:

1. Immunoglobulin A deficiency

2. Immunodeficiency due to #1

3. Multiple neurological manifestations with no structural disease on imaging and no infections etiology on work up. Suggestive of probable immunologic reaction to vaccination.

Dr. Naguib further stated, "The patient has a history of anthrax vaccination series 5 out of 6 doses among other vaccinations that preceded the evolution of symptoms in this previously healthy 37-year-old male. Makes vaccines a suspect etiology for this unusual presentation."


Stewart's records were sent to a physician at Vance Air Force Base who referred him to a hematologist.

To date government sources have not offered any solutions or assistance.

The family contacted a JAG officer. They were told the State of Oklahoma had approved help but the Surgeon General's office denied the request.

Unable to work because of his compromised immune system and continual illness, the Stewart family faces foreclosure on their home in addition to mounting medical costs.


Stewart is not the first soldier to report illness after taking the anthrax vaccinations.

A recent story reported by Knight Ridder Newspapers' writer David Goldstein, 16 people died between 1990 and 2004, after taking the vaccine. Goldstein cited the government's Vaccine Adverse Event Reporting System as his information source.

Most suffered heart, lung and immune system problems as well as cancer.

All but five died within three months of their sixth vaccination. Nearly 4,500 other recipients reported having medical reactions with nearly 8 percent listed as "serious," meaning the problems were life-threatening, required hospitalization or resulted in a major disability.

A Maine internist and leading critic of the vaccine, Meryl Nass, says the military turned "a blind eye" to the risks.

"The people who become disabled more often than not have multiple diagnoses . . . their bodies are not doing what they're supposed to be doing," Nass said.

Beginning two months ago, the military policy changed from making the anthrax vaccinations mandatory to voluntary.

Since the policy changed, half the military and civilian Defense Department personnel asked to take the shots have declined.


Almost from the beginning the anthrax vaccine has been controversial.

The FDA licensed it in 1970 but only for anthrax exposure through the skin because the disease was largely confined to the livestock industry.

"They are still testing the serum to see if it works or doesn't work," Stewart says. "They tested it in the 70s and people still got anthrax."

FDA Warning Letters were sent to the manufacturer in 1995 and 1997 threatening to revoke their license. The Gulf War Vets website says an FDA report documented 84 quality control and procedure violations by the manufacturer.

"We talked to the main immunization place in Washington and they told Kent not to take the human immunoglobulin shots because it would probably kill him," Stewart's wife Lisa said.

Meanwhile, the Stewarts feel helpless.

"The military hasn't sent him to any of their specialists," Lisa said. "We feel like they've dropped the ball."

Stewart made the choice to serve his country.

He even knew that choice might involve making the ultimate sacrifice.

He just never expected the potentially fatal shot to come from a syringe instead of a rifle.

August 12, 2005

Blumenthal Joins Battle Over Anthrax Vaccine

Courant Staff Writer

Saying the controversy over the legalities of the anthrax vaccine is critical to Connecticut National Guardsmen forced out of the service for refusing to take it, Attorney General Richard Blumenthal has joined the fight over the vaccine in U.S. District Court.

He is the sole state attorney general to enter that legal battle, one that he has been involved with since May 2000, when he asked the state Consumer Protection Department to investigate the vaccine.

In his arguments, Blumenthal says the vaccine has never been properly licensed because it has not been proved safe or effective for humans through at least two human trials.

The legal challenge to the vaccine was brought in federal District Court on behalf of six anonymous military employees, including civilians.

The outcome of the lawsuit would probably affect two of the leading opponents of the vaccine, U.S. Air Force Majs. Thomas L. Rempfer, 40, and Russ Dingle, 48, who were forced to resign from Connecticut's Air National Guard in 1998 in a dispute within the Guard over the vaccine.

Former Guard Commander Col. Walter Burns assigned them to investigate the vaccine, but after their investigation challenged the legality and safety of the vaccine, he balked and forced them out of the Guard. They later joined the Reserve as pilots and have filed their own, separate lawsuits against the military. Since then, however, Dingle has retired.

U.S. District Judge Emmet Sullivan on April 5 halted the Defense Department's mandatory anthrax vaccine inoculations for 2.4 million service members. However, the judge left untouched an emergency authorization from federal health officials allowing voluntary vaccinations, which was recently extended to January.

The Department of Defense has appealed the ruling in federal court in Washington, D.C., and Blumenthal has now filed a friend of the court brief opposing the Pentagon's position. Sullivan's ruling requires that service members be told about the unlicensed drug's possible side effects, and to consent to be vaccinated. Without consent, the military would need a presidential waiver to force use of the drug under threat of punishment.

As a result of Sullivan's rulings, the U.S. Food and Drug Administration is holding a public comment session on the vaccine, one of the failings of the licensing procedure mentioned by the judge.

Blumenthal argues that the Pentagon is using it, even though its officials are aware of the vaccine's legal-health problems; and it is the FDA, not the Department of Defense, with full responsibility for determining vaccine safety.

The Defense Department appealed Sullivan's ruling to the U.S. Court of appeals, saying the vaccine is properly licensed, safe, effective and needed for all service members to ensure their safety.

Dingle, of East Hartford, and Rempfer, of Suffield, are suing separately in the U.S. Court of Claims to get back pay and a ruling that the vaccine is illegal.

August 9, 2005

Depleted Uranium, Anthrax Vaccine & The Gulf War Syndrome, Part 1

Dr. James Howenstine, MD

More and more veterans have become chronically ill from a multitude of symptoms since the end of Gulf War I. For many years the U.S. government denied any responsibility for their mysterious symptoms. Only 7,035 men were injured in this war. A total of 580,400 soldiers served in the first Gulf War. By the end of 2000 325,000 of these troops had become disabled. This means that 56 % of those who served in the first Gulf War were disabled within less than 10 years.

In August 2004 American Free Press reported that eight out of twenty men serving in one unit during the 2003 invasion of Iraq had developed malignancies. This translates into 40 % of the soldiers in that one unit developing malignancies within a 16 month period of time. What is causing these terrible health problems?

Nine members of the National Guard from New York State recently returned from Iraq. These persons were deployed as Military Police. Two manmade forms of uranium were found in urine specimens from 4 of these 9 soldiers. Certainly soldiers in combat roles would be expected to have even greater exposure to inhaling depleted uranium dust.

Since 1943 the military has been aware of the extreme toxicity of uranium as a gas. A Oct 30, 1943 memo from Manhattan Project physicist James B. Conant to Brig. General L.B. Abrams stated that as a gas warfare instrument the radioactive material would be ground into microscopic particles forming dust and smoke and could be distributed by ground fired projectiles, land vehicles or aerial bombs. In this form it would be inhaled by personnel. They estimated that one millionth of a gram would be fatal. There are no known methods of treatment for such casualties.

The depleted uranium DU was also recommended as a permanent terrain contaminant which could be used to destroy populations by contaminating water supplies and agricultural land with radioactive dust. Current estimates suggest that the damaged soil in Iraq, Yugoslavia and Afghanistan will need four and a half billion years to recover from the radioactive effect of DU.

Some of the uranium from shells vaporizes into particles measuring 1/10 of a micron. These particles enter the atmosphere and later fall to the ground with rain. Radioactive debris has been found at both the North and South Poles. In gaseous form the chemically toxic and radioactive uranium easily enters the body through the skin or when inhaled into the lungs. Clothing and gas masks are easily penetrated. Large missiles and bombs can disperse nearly 100 % of the DU into the atmosphere whereas only 30 % of a tank shell disperses when fired. Any soldier or civilian who breathes this gas has a permanent dose of radioactive uranium RAU.

Uranium is quite dense so it is ideal for penetrating armor. The radioactive uranium is shaped into a penetrating rod 18 inches long and 3/4 inch in diameter. When these shells are fired some of the uranium contacts air and explodes into flame (pyrophoric quality).

Scientists studying the biologic effects of radiation in the 1960s reported that radioactive uranium targets the DNA. Marion Fulk, a nuclear physical chemist, who had worked for both the Manhattan project and the Livermore Nuclear Weapon Lab interprets the new and rapid development of malignancies in soldiers from the 2003 war as "spectacular and a matter of concern." She states "This is the perfect weapon (DU) for killing lots of people."

There are three effects of depleted uranium on biologic systems -radiation, chemical and particulate. The particulate effect of nano-sized particles is the most important of these three. This appears immediately after exposure and targets the master code of DNA. Simply stated depleted uranium "trashes the body." The DNA damage is so severe these patients develop multiple simultaneous cancers from different causes. This new syndrome has never been reported before and is unique to internal depleted uranium exposure. Such patients were seen in civilians in Yugoslavia after NATO bombing using DU bombs. There is currently an epidemic of cancer in Iraqi children.

Another horrifying consequence of DU exposure is damage to sperm causing many severe deformities in the children born to veterans of the first Gulf War. A group of 251 soldiers from Mississippi, who all had normal babies before service in Iraq, were studied. Sixty seven percent of their post war babies were born with severe birth defects. These children were missing legs, arms, organs or eyes and had immune system and blood diseases. In some Gulf War veterans families the only normal children are those who were born before serving in Iraq. The Department of Defense denies any knowledge of birth defects in Gulf War I veterans.

How Much Depleted Uranium Has Been Used?

Depleted uranium weapons were developed by the U.S. Navy in 1968. Depleted uranium weapons were given to and used by Israel with U.S. supervision in the Yom Kippur War in 1973 against the Arabs nations. Military research detailed the use of DU weapons at military testing grounds, bombing and gunnery ranges and civilian labs under contracts between 1974-1999. Presently 42 states have contamination from the manufacture, testing and deployment of depleted uranium. The United States has sold DU weapons to 29 countries.

In Gulf War I DU weapons were used against Iraq. Between 315 and 350 tons of depleted uranium was used in that war. The current Iraq war has expended an estimated 5 times more tonnage of DU than was used in the first Gulf War.

Japanese professor, Dr. K. Yagasaki, has calculated that 800 tons of depleted uranium is the atomicity equivalent of 83,000 bombs the size of the one which struck Nagasaki. The U.S. has used more depleted uranium since 1991 than the atomicity equivalent of 400,000 Nagasaki bombs. This includes four nuclear wars (Iraq twice, Yugoslavia and Afghanistan) and is 10 times the amount of radiation released into the air from atmospheric testing. Experts from the Department of Defense say that the U.S. has 100 million tons of DU. Using up the DU in wars afford a convenient way to dispose of some of the radioactive uranium and thus avoid some of the huge expense that careful disposing of tons of DU would entail.

The "clean up" of 34 Abrams tanks and Bradley armored vehicles that were erroneously hit by U.S. missiles during this first Gulf war was supervised by Dr. Doug Rokke. Today he is suffering ill effects from DU that entered his body in the clean up. One of the problems he has is brittle teeth. The uranium displaces calcium in both teeth and bones resulting in teeth that break. The majority of U.S. casualties in this war were from "friendly fire." Dr. Rokke relates that DU is used because it is the most effective weapon at killing and destroying everything it hits.

Thousands of tons of depleted uranium were used for decades at four bombing and gunnery ranges in Fallon, Nevada. This usage is no doubt responsible for the fastest growing leukemia cluster in the U.S. The military has denied that DU has anything to do with this cluster. The medical profession has been involved in the cover-up-just as they were hiding the adverse effects that low level radiation from atmospheric testing and nuclear power plants were producing.

A physician in Northern California was being trained in the Pentagon with other physicians months before the 2003 Gulf War started. They were told to diagnose and treat soldiers returning from the 2003 war for mental problems only. Medical professionals in hospitals and facilities treating returning soldiers were threatened with $10,000 fines if they talked about the soldiers or their medical problems. They were also threatened with jail[1] terms.

Senator Paul Wellstone informed Joyce Riley R.N., executive director of the American Gulf War Veterans Association, that 95 % of Gulf War I veterans had been recycled out of the military by 1995. Any of those continuing in military service were carefully isolated from each other, preventing critical information from being shared with new troops. One has to wonder if his airplane crash was really an accident.

My initial reaction to the 1993 Gulf War was that it was all about oil which we desperately needed. Now it appears that I was wrong. Currently there is strong evidence that we are preparing to invade Iran. Whether this invasion will be preceded by another "terrorist" attack on the U.S. is obviously unknown. Perhaps a nuclear attack on a U.S. city by "Arabs" would attract sufficient public opinion approval to warrant another U.S. invasion of a sovereign nation.

My impression currently is that there may be a more insidious and sinister aspect to the invasion of Iraq. Could we be using this nuclear war as a way to lower the population of an Arab nation? Exposing all the citizens in a nation to a daily dose of radioactive uranium dust would be certain to produce very premature deaths and inability to reproduce. These irradiated nations will have huge problems with illness of their citizens and the inability of most parents to produce healthy children for succeeding generations.

Who is going to be willing to work in irradiated oil fields knowing that their life expectancy will be reduced by many years and that there is a strong possibility that they will probably never be able to have normal children. Even salaries of a million dollars annually do not sound very attractive to me to work in those irradiation contaminated oil fields.

The new book The High Priests of War documents how Henry Kissinger had planned an attack against the Arab world in the late 1960s and early 1970s. This nicely coincided with a Middle Eastern oil crisis and the development of DU war capabilities.

Mr. Kissinger had been previously involved in plans (later implemented) to lower the population of blacks in Africa by using bio-warfare[2] programs (vaccines contaminated with HIV virus). This CIA plot was code named PROJECT MKNAOMI. The details about the development of the HIV vaccine in the NIH Cancer Division are well documented in Leonard G. Horowtz's book Emerging Viruses AIDS and Ebola Nature, Accident or Intentional?

When David J. Smith asked Vietnam Special Ops Green Beret Captain John McCarthy "who could have devised this omnicidal plan to use depleted uranium to destroy the genetic code and genetic future of large populations of Arabs and Moslems in the Middle East and Central Asia where most of the world's oil deposits are located?" he replied "It has all the handprints of Henry Kissinger."

August 4, 2005


Inside the Pentagon
Elaine M. Grossman

Six military and civilian officials challenging the legality of a Pentagon program to administer anthrax inoculations to hundreds of thousands of personnel argue in a new court brief that the government's own documents demonstrate the vaccine, prior to litigation, had "never been considered formally licensed" to protect against airborne spores.

The Defense Department says the vaccines are necessary for selected forces at risk of infection if a terrorist or enemy nation releases anthrax into the air in the United States or abroad.

After a U.S. District Court judge temporarily shut down the mandatory program in December 2003, the Food and Drug Administration hastily moved to license the vaccine for use against any kind of exposure, including inhalational anthrax (Inside the Pentagon, Jan. 8, 2004, p1).

In response, Judge Emmet Sullivan initially lifted the injunction. But he later determined the FDA had not followed its own rules in approving a broader use of the drug. In October 2004, Sullivan permanently banned the mandatory vaccine program, calling it "illegal" to force service members to be inoculated with a drug being used for an experimental purpose (ITP, Oct. 28, 2004, p1).

DOD recently resumed giving vaccines to those personnel considered at high risk of exposure, but at least for now is limited to doing so on a voluntary basis (ITP, Feb. 3, 2005, p3; and May 5, 2005, p5). Earlier this year, the FDA held a public comment period on the proposal to license the vaccine for inhalational anthrax. The agency is still reviewing the results but is widely expected to approve the new use.

Meanwhile, the plaintiffs have filed the new legal document in response to the Bush administration's bid at the U.S. Court of Appeals to reverse Sullivan's 2004 permanent injunction. In its written argument in May, the government emphasized the safety of the anthrax vaccine, saying there is no benefit to be gained by banning mandatory shots but potentially great risk in leaving personnel unvaccinated in Iraq,
Afghanistan and Korea (ITP, May 19, p1). Some defense personnel assigned to homeland security missions in the United States are also taking the six-shot anthrax vaccine series.

In March 2002, the National Academy of Sciences' Institute of Medicine called the anthrax vaccine effective "for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains."

But the complainants -- six anonymous DOD personnel potentially subject to taking the shots -- dispute the government's assertion that the safety and effectiveness of the anthrax vaccine has never been questioned.

"The plaintiffs specifically challenged, and briefed, the issue of [the anthrax vaccine's] safety and effectiveness" at the lower court, reads the new document, filed July 29. "However, the district court did not reach those issues, having instead determined that sufficient procedural deficiencies existed that mandated judgment in favor of the plaintiffs."

The complainants, who filed the lawsuit in March 2003, say they "are more than prepared to . . . continue their substantive challenges that [the anthrax vaccine] is neither safe nor effective against inhalation anthrax."

But the main thrust of the plaintiffs' argument to dismiss the appeal is that, until recently, the government itself has recognized the anthrax vaccine was not licensed to protect against inhalational anthrax. Until the specter of a potential biological weapon laid the basis for a widespread military inoculation program in 1997, the anthrax vaccine was used primarily by animal handlers and laboratory technicians whose primary risk was skin contact.

"Anthrax manifests itself in different ways based on the route of infection. Cutaneous anthrax is contracted through the skin as a result of handling infected fur or hides or some other material, and is rarely fatal," the plaintiffs write. "Inhalation anthrax has a reported mortality rate of close to 90 percent. . . . It is undisputed that the experts conducting the [1962] human field trial . . . determined that there were too few cases of inhalation anthrax to establish effectiveness of the vaccine against this form of anthrax infection."

Complainants assert a 1980 FDA advisory panel tasked with studying safety and effectiveness similarly concluded the anthrax vaccine could be deemed safe and effective only under the "limited circumstances for which it is employed." At that time, a defense-wide immunization program was not being contemplated.

The plaintiffs argue the Defense Department and the vaccine manufacturer implicitly acknowledged the vaccine was not yet licensed for inhalational anthrax when they applied to the FDA for an "investigational new drug" study on that proposed use in September 1996, as the Defense Department was gearing up for its massive inoculation
program. The application remained actively pending at FDA until the government withdrew it in January 2004, shortly after Sullivan issued the preliminary injunction.

The new brief calls a discussion of the application for a license amendment "inexplicably missing from the government's brief" to the D.C. Circuit Court of Appeals and argues it is "absolutely essential to understanding the ultimate success of plaintiffs' claims."

"In fact," the complainants say later in the filing, "the district court's preliminary injunction was based on the undisputed investigational new drug status of the vaccine, as established by the defendants' own documents."

Those supporting the government perspective on the case respond that the FDA-approved anthrax vaccine label includes no details about the route of exposure and thus does not preclude use against inhalational disease. They argue that in laboratory studies on animal subjects, the drug has been shown to be effective regardless of where in the body the disease manifests itself.

Sullivan's conclusion that the vaccine was licensed solely for skin exposure "frankly was just sort of made up," says one attorney familiar with the case, speaking on condition of anonymity. "The premise that there was some restriction in the labeling was just false because the label was nonspecific."

But plaintiff attorneys also argue the FDA's more recent findings that the vaccine license included inhalational anthrax protection from the start is "irrelevant."

"It was FDA's failure to determine that [the anthrax vaccine] was 'safe, effective and not misbranded,' which had been missing since 1972, that underlies the district court's finding that [the vaccine] is not approved for its applied [or] intended use," the plaintiffs write.

They say that will require the FDA commissioner's "final order" -- a pronouncement that both sides expect sometime soon and one that could quickly make the current case before the appeals court moot.

No date has been set yet for oral arguments in Washington.

August 2, 2005

Pentagon Employees Ask for Continued Hold on Mandatory Anthrax Vaccination Program

By David Francis
Global Security Newswire

WASHINGTON — Six U.S. Defense Department employees have asked a U.S. appeals court not to lift an injunction blocking mandatory anthrax vaccinations because the vaccine used in the program has never been formally found safe or approved for use against inhalation anthrax (see GSN, May 23).

In a brief filed July 29 in the United States Court of Appeals for the District of Columbia, lawyers for the employees asked the court to dismiss a Pentagon appeal seeking to have the injunction lifted. The challenge to the vaccination program — over fears of possible side effects — by the six anonymous military and civilian personnel led to a District Court ruling stopping the program in October 2004.

The Pentagon, in a brief filed with the court last month, said Food and Drug Administration documentation on BioPort’s Anthrax Vaccine Adsorbed [AVA] proves the vaccine is safe and effective in combating all forms of anthrax.

The plaintiffs’ lawyers have disputed this claim. They have argued that FDA’s scientific records show the vaccine to be ineffective in combating inhalation anthrax, the form military personnel would be most likely to face in the field. The lawyers have also pointed to an agency advisory panel that found the vaccine to be effective only against anthrax contracted through the skin. The agency accepted the panel’s view in 1985, but changed its position in 2003 by issuing a final order declaring the vaccine effective against inhalation anthrax. However, a federal judge found that the agency did not follow procedures in making that determination, vacated the order, and demanded that FDA officials open the rule for public comments, the brief says.

“Against this undisputed factual background, the government's claim that FDA has consistently considered AVA to include inhalation anthrax is nothing less than ludicrous. At no time did the appropriate FDA officials or experts ever make such a claim. Moreover, until finally forced to do so by the District Court's decision, FDA has carefully avoided making any official pronouncement concerning the AVA’s status,” plaintiffs argued in the brief.

The attorneys have accused the Food and Drug Administration of ignoring this scientific record on the vaccine by issuing the 2003 final rule.

“In short, there is ample undisputed, factual support for the District Court's opinion that AVA was not considered to be licensed for inhalation anthrax by FDA, DOD, or anyone else until it became politically expedient, as opposed to scientifically validated, to do so,” the brief says.

As the vaccine has never been proven safe, the Pentagon is forbidden by military law from requiring troops to take it, the plaintiffs attorney’s have argued. Under U.S. Code Title 10, the military cannot force personnel to take unapproved or investigational new drugs without giving them the option to refuse the drug.

“The District Court granted plaintiffs' motion for summary judgment and enjoined the use of AVA [Anthrax Vaccine Adsorbed] for the simple reason that the vaccine was an investigational new drug or a drug unapproved for its applied/intended use, and that defendant DOD's [Defense Department] involuntary program violated” military law, the brief states. “The undisputed facts show that the only human test of the vaccine did not provide sufficient evidence to support the vaccine's use as a prophylaxis against inhalation anthrax.”

Finally, the plaintiffs’ brief counters the government’s argument that because only six employees challenged the program, the District Court acted improperly by issuing an injunction covering the entire military. The brief says that because the vaccination program was based upon the incorrect safety determination by the Food and Drug Administration and because a mandatory vaccination program affects all military personnel, the District Court acted correctly in stopping the program across all armed services.

The plaintiffs’ brief adds that the full injunction saves the government from facing a rash of lawsuits from personnel who claim injury after taking the vaccine. “Without a military-wide injunction, this Circuit [Court] and DOD would face an unmanageable tsunami of litigation. The government complains that any judicial intervention will unduly disrupt military affairs. But the government slyly overlooks the fact that a flood of litigation would be far more disruptive to the military than simply providing informed consent” for the vaccine, the brief says.

The government has 15 days to respond to the brief, said plaintiffs’ attorney John Michels. If the court agrees to hear the appeal, a date would be set for oral arguments, Michels said.

The vaccine has been available to military personnel since May under a voluntary program, after the Food and Drug Administration approved its emergency use. Those wishing to receive the vaccine must be briefed on the risks and benefits of the treatment by their commanders and acknowledge receiving the brochure explaining these risks. The vaccine is available to troops deployed in Central Command theaters, such as Iraq and Afghanistan, and in South Korea.

As of July 7, half of military and civilian personnel offered anthrax vaccinations under the voluntary program have refused the vaccine, according to Military Vaccine Agency figures (see GSN, July 7).

FDA Commissioner Lester Crawford recently extended the voluntary program until 2006 (see GSN, July 25).