Del. legislators begin scrutiny of vaccine

By HIRAN RATNAYAKE and LEE WILLIAMS / The News Journal

10/31/2004

Representatives of Delaware's congressional delegation met with Department of Defense officials for several hours Monday in Washington, an initial step in the delegation's investigation into claims that illegal experiments using the anthrax vaccine were conducted, and continue to to be conducted, at Dover Air Force Base.

Sens. Joe Biden and Tom Carper and Rep. Mike Castle were not at the meeting. Officials from the Defense Department supplied thousands of pages of documents related to the military's controversial anthrax vaccine immunization program, known as AVIP, to the delegation staff.

Col. John Grabenstein, director of clinical operations for the program, answered several questions asked by the delegation, but details of his answers were not made available to the media. Nor was it clear whether the documents the delegation received were going to be made available to the media.

"The meeting was just the beginning," said Elizabeth Wenk, Castle's deputy chief of staff.

The delegation is still awaiting a response to its official request for an independent investigation by the Government Accountability Office and also is expected to meet with the Food and Drug Administration on the subject during the second week of November. The FDA's approval of the anthrax vaccine now administered to troops was deemed illegal Wednesday, when a federal judge halted AVIP, saying that the FDA did not accept enough public input before declaring that the anthrax vaccine was safe.

About two weeks ago, Biden said he would not call for a suspension of the anthrax program, despite the criticism that has mounted against the FDA for how it has handled the anthrax vaccine during the past decade.

"When [Biden] made those comments he was operating under the assumption that the FDA was following its rules," said Margaret Aitken, press secretary for Biden. "But the FDA didn't cross their t's and dot their i's."

http://www.delawareonline.com/newsjournal/local/2004/10/31dellegislatorsb.html

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Judge's order halts anthrax inoculation

Ruling says government failed to get adequate public input

By HIRAN RATNAYAKE, LEE WILLIAMS and STEVEN CHURCH / The News Journal

10/28/2004

In a decision affecting American military personnel around the world, a federal judge in Washington, D.C., ordered the Pentagon to halt the mandatory anthrax vaccination program that U.S. Air Force personnel in Dover have claimed made them ill.

U.S. District Court Judge Emmet G. Sullivan issued his order Wednesday, calling the program "illegal." Sullivan did not rule on whether the vaccine was dangerous, but instead chided federal officials for not accepting enough public input before they declared the vaccine safe for use.

"The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all - public scrutiny," Sullivan wrote in his 41-page opinion.

The decision was praised by service members who believe the vaccine causes a range of adverse side effects, including arthritis, neurological problems, memory loss and incapacitating migraine headaches.

Former Air Force officers who have led separate campaigns to halt the program, which they say is dangerous, also applauded the ruling.

"It means the rule of law in America applies to the entire government, including the Department of Defense and that is critical for our democracy to work," said retired Lt. Col. John Richardson, who lives in North Carolina. "I've heard from service members from Iraq to Hawaii today and they are thrilled. I think for people who have refused, they have a sense of vindication."

Retired Lt. Col. Jay Lacklen of Dover said the injunction was an important first step in what he hopes will be an ongoing investigation of the use of the vaccine at Dover Air Force Base, where opposition to the shots has been intense.

"But they also have to get to the second step, which is revealing the underlying crime of the program," said Lacklen, who criticized the program despite receiving all six anthrax vaccine shots. "I know there are some people who are right up against the wall who are taking it and they will be ecstatic that they won't have to take it now."

Following the injunction, Secretary of Defense Donald Rumsfeld wrote a memorandum to the Joint Chiefs of Staff and other military officials saying the court order had merely caused a "pause" in the anthrax vaccine immunization program, known as AVIP.

"DoD remains convinced that the AVIP complies with all legal requirements and that anthrax vaccine is safe and effective," Rumsfeld said in the memo, released by the Department of Defense.

A spokesman for the U.S. Department of Justice said the decision means service members are free to refuse the vaccine until the order is either overturned by a higher court or President Bush intervenes as commander in chief.

"It would be voluntary at this stage," department spokesman Charles Miller said. "Anybody who doesn't want it can refuse it."

Former Dover veterans said the ruling would increase awareness about the problems.

"I'm glad there's a suspension," said Danny Tam, 25, a former Air Force security policeman. Tam is considered 100 percent disabled by the Veteran's Administration due to severe migraine headaches, which military doctors have linked to the vaccine. "The men and women serving in the military are not told about the problems with the vaccine. Now, hopefully, there will be more rounds of questioning."

The judge's ruling stems from a lawsuit brought in 2003 by six anonymous plaintiffs who are in, or working for, the military. John Michels, lead co-counsel for the plaintiffs, said he expects the Defense Department and the FDA to challenge the judge's ruling.

Lawyers for the Defense Department can ask the judge to reconsider his decision, or appeal to the U.S. District Court of Appeals for the District of Columbia. Or, the Pentagon can bypass any court challenge if Bush agrees to waive a law preventing experimental drugs from being given to service members without their consent.

If Bush issues such a waiver, that would be an "explicit admission that the vaccine is not properly licensed," Michels said.

The News Journal reported Oct. 10 that a former Dover commander, retired Col. Felix Grieder, concluded after years of investigation that his troops were the subjects of illegal experiments. Problems began at Dover in May 1999 after some troops in their 20s and 30s began developing illnesses normally associated with old age. The troops received anthrax vaccine that may have contained squalene, a substance that occurs naturally in the human body but can be harmful when injected with a vaccine.

Wednesday's ruling is the latest chapter in the case pitting six service members against three powerful federal agencies: the Department of Defense, the Department of Health and Human Services, and the Food and Drug Administration. Lawyers for the agencies argued unsuccessfully in the case that the anthrax vaccine was not experimental, but "safe and effective."

The service members argued that the vaccine had never been given final approval by the FDA and asked the judge to halt the anthrax vaccination program. Sullivan issued a preliminary injunction on Dec. 22, 2003.

At that time Sullivan found that the vaccine was the kind of "investigational drug" that the 1998 federal law would not permit to be given involuntarily to service members unless the president issued a waiver.

Eight days later, the FDA classified the vaccine as a Category I drug, declaring that an expert panel had concluded the vaccine was not experimental and was safe enough to use, according to the judge's decision.

After the FDA's announcement, Sullivan canceled his preliminary injunction, allowing the Pentagon to resume the forced inoculations.

But the lawsuit continued. Eventually the lawyers for the six service members asked the judge to rule in their favor without the need for a jury trial.

On Wednesday, Sullivan granted their request, ruling that the facts that are not in dispute in the case justify halting the vaccination program.

In his ruling, Sullivan found that the FDA allowed the public to comment on whether the vaccine was safe only for 90 days in the mid-1980s. When a final ruling was issued 18 years later, the agency used studies that did not exist in the mid-1980s, Sullivan wrote. The agency should have allowed more public comments, Sullivan concluded.

"The Court is not questioning the science of the decision, they're questioning whether the FDA did what they're supposed to do under the procedural rules," Delaware attorney Herb Feuerhake said. "What the court is saying is that they did not hold adequate hearings on the issue."

Contact Lee Williams at 324-2362 or at lwilliams@delawareonline.com. Contact Hiran Ratnayake at 324-2547 or hratnayake@delawareonline.com. Contact Steven Church at 324-2786 or at schurch@delawareonline.com.

http://www.delawareonline.com/newsjournal/local/2004/10/28judgesorderhalt.html

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DAFB civilians face 'backdoor draft'

Many of the 1,000 key workers may quit over forced vaccinations

By LEE WILLIAMS and HIRAN RATNAYAKE / The News Journal

10/24/2004

A Department of Defense plan to increase the number of civilian personnel who receive the anthrax vaccine could lead to a mass exodus among the more than 1,000 skilled employees at Dover Air Force Base, union officials say.

A labor law expert says the requirement to take the anthrax vaccine may violate the workers' constitutional rights.

And a civilian engineering and airfield maintenance team based at Dover, which just received orders to take the controversial shots, is already balking at the requirement.

Nationwide, the defense department's 800,000 civilian employees are being drawn into the controversy over the anthrax vaccination program simmering among Air Force pilots and crews at Dover and around the country. The civilians, many former military, work as accounting technicians, aircraft mechanics, air traffic controllers and civil engineers, in addition to holding positions in the food service, supply, maintenance and medical fields.

A recent Pentagon initiative intended to make the military more mobile also affects civilian military workers: They must be ready to be deployed with troops in war zones around the world. That could include requiring vaccinations to protect them from biological attacks.

All U.S. troops deployed overseas must take a series of six anthrax vaccinations. Many around the world have refused and face possible court martial. Civilians employed by the military can be fired for failure to comply with military orders.

The News Journal reported earlier this month that the troops received anthrax vaccine starting in 1999 that may have contained squalene, a substance that can be used to increase the potency of vaccine. Some researchers believe that even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches.

"It's conceivable that the entire Department of Defense civilian work force is at risk of the anthrax vaccine," said Brent Reynolds, president of the American Federation of Government Employees Local 1709 Inc., the union representing Dover's civilians. Reynolds is a jet aircraft mechanic at the base.

"In the 1960s, they wouldn't draft anyone over 35. Now they want to make guys in their 50s and 60s deployable," said Peter Buono, Local 1709's executive vice president and a machinist at the base.

The union's fight against the vaccination program so far has been unsuccessful.

Charges Reynolds and Buono filed with the Federal Labor Relations Authority were dismissed. They've tried without success to take their concerns to Air Force Col. John Pray, the base commander.

"He's the CEO of the base, but he won't meet with us," Reynolds said. "We can't even get him to the table to negotiate the shots."

Pray did not respond to numerous calls or e-mails seeking comment about the union leaders' concerns.

Pentagon spokesman James Turner said in a written statement that anthrax vaccinations are required for all Defense Department civilian workers designated as "emergency essential" and deployed or stationed in higher threat areas such the Middle East or Korea.

"The number of designated emergency essential civilians is a very small portion [generally less than 30,000] of the overall number of DoD personnel currently required to receive anthrax vaccinations in the higher threat areas," Turner wrote.

Dover's union leaders don't buy it. Their national union joined 39 others last month in a letter to every U.S. senator calling on the lawmakers to stop the forced vaccinations.

"It's nothing more than a back-door draft," Reynolds said. "If we're deployable, that makes us civilians in uniform. Are they going to issue us uniforms too? Are they going to hand us a gun? From now on, once we're all deployable, they're going to expedite the anthrax vaccination program. Many of our members are older. If they're required to take the shots, there's going to be a mass exodus."

Officials at Dover would not discuss potential losses in their civilian work force.

Neither Reynolds nor Buono could estimate the cost to replace union workers at the base.

"It would be in the millions," Buono said.

When pilots in 1999 were forced to take the vaccine, 55 pilots out of 120 in the Air Force Reserve wing stationed at Dover resigned, leaving the base below strength. The military has never released the cost of replacing them.

Many are older workers

Union officials say the 2004 Defense Authorization Act, known as the National Security Personnel System, is nothing more than an attempt to curb the unions' power and militarize their members.

According to Defense Department documents, the military hopes to create a more agile and responsive work force, where "employees and/or a work unit can be easily geographically moved either temporarily or permanently, to meet changing mission requirements. ..."

Most civilian defense employees are in their late 40s and 50s and sometimes 60s, much older than their military counterparts, union officials said. Many already have medical problems and do not want the added risks associated with the anthrax vaccine, which some researchers believe cause severe autoimmune disorders.

"We represent Desert Storm and Desert Shield veterans. They're not looking forward to going back to a hot LZ [landing zone]," Buono said.

At the Pentagon, Turner repeated that the vaccine is safe, even for older civilian workers.

Reynolds and Buono said their members are afraid to come forward because they are supervised by military personnel and fear reprisals.

"These guys know they'll be disciplined in some way if they talk, on evaluations or bonuses, or by withholding their promotions," Reynolds said.

The union leaders predict chaos will result if their members resign en masse.

"Without us, they wouldn't be able to exist. They need our experience," Reynolds said. "You just can't walk in here and start working on a [C-5] aircraft that's two football fields long. You need experience."

The union wants the vaccination program to be voluntary.

"I'd prefer to take my chances with the disease," Buono said.

Problems emerged at Dover in May 1999 after some troops in their 20s and 30s began developing illnesses normally associated with old age.

Retired Col. Felix Grieder, who commanded Dover Air Force Base at the time, has concluded that his troops were the subjects of illegal experiments at the base. Grieder halted the vaccination program in 1999, a move he has said brought an end to his military career.

Military and international law prohibits giving troops drugs without their knowledge and consent. Federal law prohibits administering drugs that have not been approved by the Food and Drug Administration.

Neither the military nor the FDA test for squalene, a substance that occurs naturally in the body. Some experts say even trace amounts of squalene can suppress the immune system when the substance is injected into the body.

Testing by the FDA in 2000 detected squalene in varying amounts in the vaccine. The substance was detected in all the vaccine sent to Dover in 1999, but not in vaccine sent to other military installations.

The Air Force and the Department of Defense have continually stressed the safety of the vaccine, despite the claims of military personnel who say it made them ill.

The military has secretly experimented with squalene to test its ability to boost the effectiveness of some vaccines. The Department of Defense has admitted conducting tests on humans using squalene in vaccines in Thailand. But the military said any contamination in the vaccine in Dover must have occurred accidentally.

The military has said it suspects that the FDA conducted faulty tests and that the vaccine contained no squalene. It also contends that the amounts of squalene the FDA said were contained in the vaccine would have been too small to affect human health.

For the union, the vaccine has become an issue of top concern.

"The anthrax shots is the single biggest concern on this base in the past 20 years," Reynolds said.

Previous protests

Controversial immunizations and a reliance on civilian labor are nothing new to the U.S. military.

George Washington, while commander-in-chief of the Continental Army, caused an uproar by requiring militia men to submit to small pox vaccinations before they were allowed to fight.

"Washington created quite the row back then, getting all those Minutemen to come in, stand in line and get the small pox shot," said retired Army Maj. Gen. Dr. William Duncan. "In those days they actually gave the soldiers a dose of the small pox germ."

Duncan, a medical doctor and military historian, said the military's reliance on civilian labor has been increasing over time, because civilians provide a highly trained, but more importantly, stable work force.

"Military personnel generally rotate to new assignments every two or three years," he said. "There has always been a need for the civilians' stability at the camps and bases around the country. The technical experience needed to maintain a C-5 is phenomenal. You'll find the vast majority of people maintaining C-5s and helicopters are civilians, because they'll be there today, tomorrow and next week."

Legal precedent

Attorneys who specialize in labor and employment law say the mandatory nature of the anthrax vaccination program raises concerns for the civilian defense workers.

"The military operates with the attitude that they're totally unaccountable under the law," said Wilmington attorney Thomas Neuberger. "My point is, I have engaged in heavy-duty litigation with the Pentagon, and they think they can do anything."

By requiring the vaccine, the Pentagon may be violating the constitutional rights of the civilian work force, in addition to federal labor laws, Neuberger said.

"Civilians have rights - entitlements to life, liberty and the pursuit of happiness - and happiness could very well mean your job," he said. "The military is not above the law. They will be handled by Congress, who will take them to their knees."

Local attorney Herb Feuerhake is troubled by what he sees as the Orwellian nature of the mandatory vaccinations.

"It comes down to the motivation of the Department of Defense. Presumably, these civilians could be sent to a remote location fraught with the potential for disease. It sounds like the clause in the contract covering vaccinations may have been insisted upon by the union to protect the workers," he said. "But here, it is being twisted around to force people to do something they do not want to do. That's what's odd. Something that was supposed to protect the worker is now feared."

The military would not comment on the legal issues posed by the civilian program.

Union leaders say they will continue to fight against the mandatory vaccinations.

"I'm trying to represent my members and protect their lives," Reynolds said. "I've got 1,000 lives to be concerned about."

Contact investigative reporter Lee Williams at 324-2362 or lwilliams@delawareonline.com. Contact Hiran Ratnayake at 324-2547 or hratnayake@delewareonline.com

http://www.delawareonline.com/newsjournal/local/2004/10/24dafbciviliansfa.html

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Squalene still used, author says

Book cites tests done by Tulane scientist

By HIRAN RATNAYAKE and LEE WILLIAMS / The News Journal

10/23/2004

The military is still conducting illegal experiments on troops at Dover Air Force Base and elsewhere - and has done so for more than a decade - according to the author of a book published this week.

In his book, "Vaccine A," published by Basic Books, Gary Matsumoto says the government since 1987 has injected soldiers with an anthrax vaccine containing squalene to increase its potency.

Some scientists say that injecting even trace amounts of squalene into the body can cause serious illness. Pentagon spokesman Jim Turner on Friday denied the military has ever added squalene to the vaccine.

Matsumoto worked with immunologist Pam Asa, who conducted research on squalene and edited the scientific portions of the book. They said Air Force personnel getting shots today at Dover, and other bases around the nation, are risking their lives by doing so.

Key to their conclusions is Asa's finding that troops who receive the vaccine develop antibodies to squalene in their blood. Asa said that strongly indicates the vaccine contains squalene. Squalene is a fat-like substance that occurs naturally in the body. But Asa and other scientists contend that squalene injections suppress the immune system.

Asa, a visiting professor at Tulane University in New Orleans, sampled the blood of about 35 patients as recently as March - including six from Dover Air Force Base. In June she received results of tests that determined that 18 of them had antibodies to squalene.

Based on their shot records and illnesses, she concluded that recently manufactured anthrax vaccine lots 073, 048, 066, 068, 070 and 071 contained squalene. Although the military has not revealed the destination of all the lots, Asa said vaccines from Lot 071 were sent to Dover. This is the first evidence that recently produced lots of the vaccine may contain squalene.

"People who received that lot number had autoimmune disease," she said. "And they had antibodies in their blood to squalene. Those were my tip-offs."

Asa said the patients who tested positive suffered from severe joint and muscle pain, rheumatoid arthritis and lupus. She already has published two studies during the last four years that show antibodies to squalene in troops who received the anthrax vaccine.

The second study, published in the peer-reviewed journal Experiment and Molecular Pathology in August 2002, tested four patients for antibodies to squalene before they received the shots in May and June 1999. One of the patients was from Dover Air Force Base. None of these patients had antibodies to squalene before they had the shots. After they received the shots, they did.

Asa noted that her findings only indicate the presence of squalene antibodies. She said the only way to determine for certain the vaccine contains it is to test the actual vaccine, something the military has refused to do for the past five years.

The Food and Drug Administration found squalene in samples of specific lots that were sent to Dover in June of 1999 but didn't announce their findings until September 2000. The military has said on its anthrax vaccine Web site that the squalene was a result of faulty lab testing by the FDA. The FDA has declined comment on the issue.

On Thursday, the Defense Department said in an official letter that the anthrax vaccine is safe and that no troops were subjected to medical experiments. The letter was a response to Delaware's congressional delegation for an investigation into whether troops at Dover Air Force Base received experimental anthrax vaccine in 1999. The letter consisted of a copy of a question-and-answer page from the Defense Department's anthrax information Web site, which has been criticized by civilian scientists for its unattributed statements and lack of signed articles.

The delegation requested the investigations after The News Journal reported earlier this month that troops at the Dover base in 1999 received anthrax vaccine that may have contained squalene. The newspaper interviewed dozens of current and former pilots and crews who said they became ill after receiving squalene-tainted vaccine.

"This whole issue would be resolved if they would allow a neutral agency to pull vials off the clinic shelves and test them," said retired Lt. Col. Jay Lacklen, who has tested positive for squalene after he received shots at Dover in 1999. "But the DOD [Department of Defense] won't let anyone test them. Those vials are locked down like a top-secret memo."

Contact Hiran Ratnayake at 324-2547 or hratnayake@delawareonline.com. Contact investigative reporter Lee Williams at 324-2362 or lwilliams@delawareonline.com.

http://www.delawareonline.com/newsjournal/local/2004/10/23squalenestillus.html

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Vaccine survey shows trouble at DAFB

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

By HIRAN RATNAYAKE and LEE WILLIAMS / The News Journal

10/19/2004

Troops vaccinated against anthrax at Dover Air Force Base in 1999 were more likely to get sick than those vaccinated elsewhere, according to research to be published next month.

Walter Schumm, a professor at Kansas State University and a retired colonel in the Army Reserve, analyzed a 4-year-old survey by former Air Force Capt. Jean Tanner. In 2000, Tanner surveyed the troops in her unit in Dover and found that 32 percent who received the anthrax vaccine had such symptoms as severe joint pain, memory loss and arthritis.

"There was something at Dover Air Force Base that was different," Schumm said. He compared the rate at the base to the military's own estimates of adverse reactions to the vaccine worldwide.

Don Whitley, a major in the Air Force Reserve, said he may have filled out Tanner's survey. Whitley said he recalled talking with Tanner at the time and that she was troubled about the vaccine. Whitley received all six shots, and he reported his symptoms to military doctors.

"It was dismissed as not being part of the vaccine," he said.

Tanner could not be reached for comment.

Schumm's analysis is scheduled to appear next month in the medical journal Medical Veritas. His research has been published in several medical journals during the past 25 years. Schumm has a doctorate in family studies from Purdue University.

Pentagon spokesman James Turner said he was unaware of Schumm's research. He said the Defense Department believes the vaccinations administered in Dover were safe.

"We are very confident of the scientific assessments and conclusions that indicate no abnormal pattern of adverse events associated with anthrax vaccine when compared to other routine vaccines," Turner said.

Tanner mailed surveys to the home addresses of 252 members of her unit who received the vaccine in January 2000, according to Schumm's report. They were asked to list specific symptoms related to the vaccine.

The survey was mailed eight months after Col. Felix Grieder temporarily suspended the vaccination program at Dover. Grieder, who lives in Texas, now says his troops were used as guinea pigs in illegal medical experiments by the government at the base.

Grieder's troops received anthrax vaccine that may have contained squalene. Some experts say even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss, miscarriages and incapacitating migraine headaches. The military has tested squalene on humans in Thailand and other foreign countries to boost the effect of some vaccines.

The military has conducted no specific research into the health effects of the vaccines administered in Dover. Tanner's is the only known survey of troops taken while they were receiving their series of six shots.

Military officials strongly deny conducting illegal experiments and deny a link between the anthrax vaccine and health problems.

Just over half of the members of Tanner's unit responded to the survey. She counted those who did not respond as not having reactions to the vaccine.

Schumm found Tanner's survey by researching the anthrax vaccine on the Internet.

While Schumm makes no mention of squalene in the article, he said those who received the vaccine in Dover at the time had an abnormally high number of reactions. The rate of adverse reactions to the vaccine varied according to what symptoms were considered adverse, he said.

For instance, 82 of the 252 subjects met the military's criteria for a systemic reaction to the vaccine, a rate of 32.1 percent. Using the stricter criteria established by the Centers for Disease Control and Prevention, 47 potential subjects had adverse reactions, a rate of 18.7 percent.

The military has estimated only 0.007 percent of military personnel experience adverse reactions to the vaccine. Throughout his research, Schumm said he has never encountered rates of adverse reactions approaching the rates at Dover.

The survey was not designed as a scientific experiment, Schumm said. Tanner did not have responses from a control group of people who did not receive the anthrax vaccine.

But Schumm said the military should have investigated the survey results because they were so striking.

"It's a 32 percent rate of reactions," Schumm said. "Even just out of curiosity, it should have led to an investigation."

In a letter sent Thursday to Secretary of Defense Donald Rumsfeld calling for an investigation into the anthrax vaccination program, Delaware's congressional delegation noted "a great deal of unnecessary confusion and anxiety has been caused by the handling of this issue." The military has said it is preparing a response.

In addition to the Defense Department, the delegation also called for an investigation by the Government Accountability Office, formerly known as the General Accounting Office, and the House and Senate Armed Services Committees.

"From what I've seen, more people have died from complications with the anthrax vaccine than have been killed by anthrax," Schumm said.

Contact Hiran Ratnayake at 324-2547 or hratnayake@delawareonline.com.

Contact investigative reporter Lee Williams at 324-2362 or lwilliams@delawareonline.com.

VACCINE OPPONENTS REACT TO STUDY'S FINDINGS

Several former Air Force personnel who received their anthrax vaccinations at Dover Air Force Base starting in 1999 reacted Monday to news that the number of people who experience adverse reactions to the shots at Dover was abnormally high. The study by University of Kansas Professor Walter Schumm is scheduled to be published next month.

Felix Grieder

Col. Felix Grieder, a former base commander, said he felt somewhat vindicated by news of Schumm's study.

Grieder has devoted the past five years to investigating the Dover vaccination program, and has concluded that his troops were used as guinea pigs.

"At a minimum, this research further highlights the need for a timely and thorough investigation," Grieder said.

Danny Tam

Danny Tam was a former Air Force security policeman who received his first anthrax vaccination at Dover. After the shots, Tam was medically discharged by the Air Force for migraines, which his medical records indicate were linked to the vaccine. Tam is considered 100 percent disabled by Veterans Affairs.

Tam said Schumm's research only confirms something he has known for a while - the anthrax vaccine is not safe.

"I think they should look into it more," Tam said. "They're not researching it, and there are going to be a lot more soldiers going through exactly what happened to me. I really appreciate those folks who are willing to step up and study it. All we're getting is a big runaround."

Barbara Welsh-Rosenblum

Retired Air Force Sgt. Barbara Welsh-Rosenblum blames the anthrax vaccine for five miscarriages. Her last duty station was Dover Air Force Base.

She said that if the Air Force wanted to conduct a study now, it would still be possible to find the personnel who received the vaccine at Dover.

"The Air Force is like a small family," she said. "They could locate the people who were there. It would take a bit of work, but they could do it."

Welsh-Rosenblum said she would cooperate with any study.

"I'd do anything so that no one has to go through what I did."

Jay Lacklen

Lt. Col. Jay Lacklen served as one of Grieder's C-5 pilots. Lacklen, who is now retired, suffers arthritis he believes was caused by the anthrax vaccinations he received at Dover.

Lacklan said the evidence of illness from the vaccine in Dover is so powerful that any serious investigation would uncover the problems.

"Compare that to all of the congressional committees, with all their money and subpoena powers," Lacklen said. "This one guy, one scientist, how did he make this discovery when all these people with money didn't?"

Lacklen pointed out that the government often cites the safety of the anthrax vaccine and several scientific studies supporting the efficacy of the vaccine on its Web site.

"These vaunted scientists go on and on about how effective and safe the vaccine is," Lacklen said. "Why didn't they know about this? Why won't the military allow further off-the-shelf testing of the vaccine? That would confirm or deny its safety right there."

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

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Pentagon silent on investigation

Delaware delegation calls response to their letter 'unacceptable'

By LEE WILLIAMS and HIRAN RATNAYAKE / The News Journal

10/22/2004

The Department of Defense Thursday rehashed previous statements in its official response to calls by Delaware's congressional delegation for an investigation into whether troops at Dover Air Force Base received experimental anthrax vaccine in 1999.

In the written response, Assistant Secretary of Defense William Winkenwerder said the vaccine is safe and that no troops were subjected to medical experiments.

Winkenwerder's letter did not say whether the Defense Department would conduct its own investigation or cooperate with one by an independent agency, as requested by the Delaware delegation.

Winkenwerder claimed the allegations of illegal experiments on troops already have been investigated and proven to be unfounded.

Most of his letter consisted of a copy of a question-and-answer page from the Defense Department's anthrax information Web site. The site has been criticized by civilian scientists for its unattributed statements and lack of signed articles.

On Oct. 13, Democratic Sens. Joe Biden and Tom Carper and Republican Rep. Mike Castle sent a joint letter to Secretary of Defense Donald Rumsfeld calling for an investigation by the Defense Department. They also sent requests for investigations to the chairs of the House and Senate Armed Services committees and the comptroller general of the Government Accountability Office.

Reaction from the delegation and from others who have asked the military for answers about the vaccine was that the response did not address key questions about the safety of the program.

"We are clearly not satisfied with the response," said Margaret Aitken, a spokeswoman for Biden. "It is an unacceptable answer, and we plan on pressing further."

Aitken said Biden's office plans to continue its request for independent investigations into the allegations.

Bill Ghent, a spokesman for Carper, declined to say whether his office was satisfied with the Defense Department's response.

"This letter is only the first step in what's probably going to be a long process," Ghent said. "The Defense Department has reiterated its previous statements - that the vaccine is safe and that squalene has never been added to the vaccine at any time."

The Defense Department also is preparing a briefing for lawmakers and their staffs.

In a joint statement, the three lawmakers said, "We appreciate the Department of Defense's prompt response to our request regarding a thorough investigation, and we are currently in the process of reviewing the extensive research and supplemental materials that were referred to in the DoD letter."

Winkenwerder's letter cited several studies that concluded the anthrax vaccine, which has been in use for decades, is safe. The letter cited no studies of the vaccine's health effects when it contains squalene.

Problems began at Dover in May 1999 after some troops in their 20s and 30s began developing illnesses normally associated with old age.

The delegation requested the investigations after The News Journal reported earlier this month that troops at the Dover base in 1999 received anthrax vaccine that may have contained squalene. The newspaper interviewed scores of current and former pilots and crews who said they became ill after receiving squalene-tainted vaccine.

Neither the military nor the FDA test for squalene, a substance that occurs naturally in the body and has been used to boost a vaccine's effect. Some experts say even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches.

Retired C-5 pilot Lt. Col Jay Lacklen blames his arthritis on squalene-tainted anthrax vaccinations he received at Dover.

Lacklen was not pleased with the Pentagon's response.

"This is another abdication of responsibility on the anthrax program," he said. "Commanders refuse to publicly endorse the program. The Defense Department refuses to take responsibility for validating the program and Congress refuses to demand scientifically valid answers of DoD. When everyone is ducking responsibility, something nefarious lurks in the program."

The government since 1987 has illegally injected soldiers with an anthrax vaccine using squalene to increase its potency, according to a book published Tuesday by Gary Matsumoto. Matsumoto said the Defense Department chose its words carefully in a passage of the letter stating that four independent panels have concluded that vaccines administered by the Department of Defense are safe.

"They're studiously avoiding any reference to the new vaccine, the one that has contained squalene since 1987," he said. "The question is which vaccine are you talking about? Are you talking about the licensed vaccine or the new one that has contained squalene since 1987?"

Former Dover Air Force Base commander, retired Col. Felix Grieder, has concluded that his troops were the subjects of illegal experiments at the base.

"This tepid response from DoD is an affront to the citizens of Delaware and to the men and women of our Armed Forces. It totally avoids the request for more specific answers to explain what happened at Dover AFB in 1999," Grieder said Thursday night.

Grieder halted the vaccinations in 1999 when his troops began getting sick. The program resumed when the Department of Defense reassured military personnel that it was safe.

Contact investigative reporter Lee Williams at 324-2362 or lwilliams@delawareonline.com. Contact Hiran Ratnayake at 324-2547 or hratnayake@delawareonline.com.

http://www.delawareonline.com/newsjournal/local/2004/10/22pentagonsilento.html

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Fearful pilots reluctant to speak out
Many would be grounded if military knew the extent of their ailments

By HIRAN RATNAYAKE and LEE WILLIAMS
The News Journal
10/17/2004

As Air Force personnel in Dover struggle with fears about the anthrax vaccine and tainted lots, active and retired military pilots also are frightened about another scenario: Being grounded.

Dozens of active and retired military pilots who fly commercially were afraid to speak out publicly when interviewed by The News Journal about the anthrax vaccine and squalene. They said their careers could be jeopardized if the extent of their illnesses was made known.

Pilots stand to lose a lot. In 2002, median annual earnings of airline pilots, co-pilots and flight engineers were $109,580. The median annual earnings of commercial pilots were $47,970.

Aviation medical examiners, on a contractual agreement with the Federal Aviation Administration, evaluate the health of pilots to determine whether they are physically and mentally capable of flying an airplane.

Pilots who fly for major airlines, known as Class 1 pilots, receive physicals every six months. Pilots who fly exclusively for private corporations, known as Class 2 pilots, may be required only to receive annual physicals.

If a pilot is exhibiting signs of autoimmune disease, he or she must instantly be grounded until further investigation, said Dr. John Hocutt Jr., a Wilmington-based aviation medical examiner. "Autoimmune diseases are very serious," he said.

Some civilian researchers, such as Dr. Pamela Asa of Tulane University, believe that trace amounts of squalene injected into the human body suppress the immune system, causing autoimmune disease. Former Dover Air Force Base commander Col. Felix Grieder has accused the military of running an illegal experiment on his troops by adding squalene to the anthrax vaccine.

As Hocutt conducts detailed examinations of the pilots - with an emphasis on vision and previous medical history - he also relies on how forthright they are about their health.

Hocutt has examined 2,000 to 3,000 pilots, several of them former Air Force pilots out of Dover who now fly commercially, in his 20 years as an aviation medical examiner. In that time, he has denied about 25 pilots from flying. According to the FAA, 3,444 pilots were denied their license for medical reasons in the United States in 2003. Data for Delaware were not available.

Arthritis and memory loss can be symptoms of autoimmune disease. Hocutt said it would be very difficult for a pilot who has severe joint pain and arthritis to pass the physical - even if they neglect to mention the symptoms on the physical's questionnaire. But it's possible that they could pass the physical if they suffered from intermittent memory loss.

"They could seem perfectly normal when they come in to see me. But if they don't tell me the truth on the form, it would be possible for them to get by," Hocutt said. "You have to be absolutely healthy to fly."

http://www.delawareonline.com/newsjournal/local/2004/10/17fearfulpilotsre.html

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Four inquiries into anthrax allegations demanded
Del. delegation gives Rumsfeld month to report on squalene use

By LEE WILLIAMS and HIRAN RATNAYAKE
The News Journal
10/15/2004

Delaware's congressional delegation officially called for four investigations Thursday into allegations that Dover Air Force Base pilots and crews were used as guinea pigs to test experimental anthrax vaccine.

Sens. Joe Biden and Tom Carper and Rep. Mike Castle jointly sent letters, calling for separate investigations to Secretary of Defense Donald Rumsfeld, the chairs of the House and Senate Armed Services Committees and the comptroller general of the Government Accountability Office.

"At a minimum, a great deal of unnecessary confusion and anxiety has been caused by the handling of this issue," the letter to Rumsfeld states. "At a maximum, intentional actions or unintentional incompetence may have created a health hazard for our personnel."

The letter to Rumsfeld gives the defense secretary until Nov. 15 to provide a detailed report.

"I'm happy. It's five years late, but well done," said retired Lt. Col. Jay Lacklen, a former Dover C-5 pilot whose health was affected by the shots.

"It's a good first step, but they should halt the vaccination program while they're conducting the investigation," Lacklen said.

Pentagon spokesman Jim Turner said he could not comment because he hadn't seen the letters Thursday evening. The military has denied it tested an illegal vaccine on troops in Dover.

In a written release, the lawmakers cite recent media reports for raising concerns about the vaccination program.

Problems began at Dover in May 1999 after some troops in their 20s and 30s began developing illnesses normally associated with old age.

The News Journal reported Sunday that a former Dover commander, retired Col. Felix Grieder, concluded that his troops were the subjects of illegal experiments at the base. The troops received anthrax vaccine that may have contained squalene.

Neither the military nor the FDA test for squalene, a substance that occurs naturally in the body and has been used to boost a vaccine's effect. Some experts say even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches.

In their letter to Rumsfeld, the lawmakers focused on several issues raised in The News Journal report.

"As part of resolving this issue, we would like to know the results of the research we understand the Department has done on the effects of squalene in vaccines," the letter states. "In addition, it is important to explain the rationale for the Army's decision to seek a patent for a new anthrax vaccine that includes squalene."

Grieder halted the vaccination program in 1999, a move he said brought an end to his military career. Testing by the Food and Drug Administration detected squalene in varying amounts in the vaccine. The substance was detected in all the vaccine sent to Dover, but not in vaccine sent to other military installations.

The Air Force and the Department of Defense have continually stressed the safety of the vaccine, despite the claims of military personnel who say it made them ill.

The military has secretly experimented with squalene to test its ability to boost the effectiveness of some vaccines. The Department of Defense has admitted conducting tests on humans using squalene in vaccines in Thailand. But the military said any contamination in the vaccine in Dover must have occurred accidentally.

The military has said it suspects that the FDA conducted faulty tests and that the vaccine contained no squalene. It also contends that the amounts of squalene the FDA said were contained in the vaccine would have been too small to affect human health.

http://www.delawareonline.com/newsjournal/local/2004/10/15fourinquiriesin.html

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Biden, Carper, Castle want answers
Delegation asks military to investigate whether pilots, crews used as guinea pigs

By LEE WILLIAMS and HIRAN RATNAYAKE
The News Journal
10/12/2004

Delaware's congressional delegation on Monday called on military officials to investigate whether the Defense Department used troops as guinea pigs to test illegal anthrax vaccinations at the Dover Air Force Base in 1999.

Sen. Joe Biden, Sen. Tom Carper and Rep. Mike Castle said they will send a letter to Secretary of Defense Donald Rumsfeld asking him to look into the allegations. They also said an outside investigation may be necessary.

The News Journal reported Sunday that former base commander Col. Felix Grieder concluded after years of investigation that his troops were the subject of illegal experiments in Dover. The troops received anthrax vaccine that may have contained squalene. Some experts say even trace amounts of squalene can suppress the human immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches.

The military has secretly experimented with squalene to test its ability to boost the effect of some vaccines. But the military denies it tested squalene in Dover and has said any contamination in the vaccine must have occurred accidentally.

"If it was intentional, I want to see people go to jail," Biden said. "I am outraged if it's intentional."

In addition to the letter to Rumsfeld, Biden wants investigations by the House and Senate Armed Services Committees and the Government Accountability Office.

"I want to know, if it was intentional, what compensation will take place; and if it was negligence, who was responsible and what the federal government will do," Biden said.

Castle said an independent investigation by a presidential or legislative commission may be necessary.

"We may need to appoint individuals with medical knowledge and no vested interest," Castle said. "We may need an outside agency beyond the military."

Carper said, "It may well also be prudent to ask for an independent investigation by the GAO, as well as by the House and Senate Armed Services Committees. The bottom line is we need to take these allegations seriously and follow up diligently, and we will."

Ex-pilot wants action

Col. Jay Lacklen, a retired Dover pilot who has spearheaded a public awareness campaign about problems at Dover, has seen congressional hearings focused on problems with the anthrax vaccine. Despite huge staffs, subpoena power and congressional prestige, the hearings accomplished little, Lacklen said.

"Now, if they go in armed with the questions they really need, such as squalene, and if they can just make someone talk, I'll be happy," said Lacklen, who suffers from debilitating arthritis he believes was caused by squalene in the anthrax vaccine he received.

Problems began at Dover in May 1999, after some troops in their 20s and 30s began developing illnesses normally associated with old age.

Grieder, the former base commander, halted the vaccination program, a move he said brought an end to his military career. Subsequent testing by the Food and Drug Administration detected squalene in varying amounts in the vaccine. The substance was detected in all the vaccine sent to Dover, but not in vaccine sent to other military installations. The military no longer tests for squalene.

"In my opinion, there was illegal medical experimentation going on," Grieder, who lives in Texas, told The News Journal.

The military has said it suspects that the FDA conducted faulty tests and that the vaccine contained no squalene. It also contends that the amounts of squalene the FDA said were contained in the vaccine would have been too small to affect human health.

However, a group of civilian scientists led by Pamela Asa of Tulane University has conducted two studies that found evidence of squalene injections in the blood of troops. The scientists also say trace amounts can cause harm.

Castle said he was struck by the age of the troops reporting medical issues they said were caused by the anthrax vaccine.

"I am very concerned about the young people getting this," Castle said. "We're dealing with fit individuals in the military. Secondly, they're used to hardships. If they say they're sick, it's very real."

History of secret tests

Government officials have acknowledged that the Department of Defense secretly tested squalene on human beings in Thailand. Grieder believes they did the same in Dover. In a March 1999 report, the GAO accused the Defense Department of a "pattern of deception" and said the military confirmed human tests involving squalene only after investigators found out about them.

The Defense Department made anthrax inoculations mandatory for all active-duty military personnel in 1998. The immunization order remains in effect today, and more than 1.9 million troops have received the inoculations.

Officials at Dover Air Force Base and at military offices in Washington were unavailable Monday because offices were closed for Columbus Day.

http://www.delawareonline.com/newsjournal/local/2004/10/12biden,carper,ca.html

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Ex-DAFB commander says troops used as guinea pigs
Military denies that illness of pilots, crew caused by squalene

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

A former Dover Air Force Base commander says military officials used his troops as guinea pigs in illegal medical experiments under the government's controversial anthrax vaccination program.

After some of his troops in their 20s and 30s began developing arthritis, neurological problems, memory loss and incapacitating migraine headaches, Col. Felix Grieder took a drastic step. In 1999, he halted the vaccination program in Dover, a move he said ended his military career. The decorated Air Force colonel has spent the past five years trying to discover the truth about the vaccine program in Dover, where he commanded 4,000 troops.

"In my opinion, there was illegal medical experimentation going on," says Grieder, who lives in Texas.

Grieder has interviewed scores of his former pilots and crew who say they have had life-altering reactions to the vaccine.

"They would have no reason to lie. I believed them," he recalls. "I wanted to talk to them face to face."

Dover is now ground zero in the controversy because troops there were injected with anthrax vaccine containing squalene, a fat-like substance that occurs naturally in the body. Squalene boosts a vaccine's effect, but some scientists say injecting even trace amounts of it into the body can cause serious illness.

Government officials have acknowledged that the Department of Defense secretly tested squalene on human beings in Thailand. Grieder believes they did the same in Dover.

In a March 1999 report, the General Accounting Office accused the Defense Department of a "pattern of deception" and said the military confirmed human tests involving squalene only after investigators found out about them.

The Department of Defense says vaccine sent to Dover was accidentally contaminated with squalene. Grieder and other officers believe, however, that it was intentionally introduced to test pilots and crew in Dover.

The Defense Department made anthrax inoculations mandatory for all active-duty military personnel in 1998. The immunization order, which remains in effect today, calls for six shots over an 18-month period. Defense officials deny that military personnel were illegally used as guinea pigs to test a vaccine containing squalene.

But a News Journal investigation raises significant questions about the military's denials and the safety of the vaccine:

• Of the first 50 batches of vaccine distributed worldwide for the mandatory inoculations, only five contained squalene - and those were all shipped to Dover. After denying for more than a year that there was squalene in the vaccinations given at Dover, the Air Force admitted in 2000 that it had been wrong.

• The five batches of vaccine sent to Dover contained increasing concentrations of squalene, Food and Drug Administration tests show. Some scientists say the pattern of squalene concentration could indicate that the military was measuring the troops' response to different dosages. Professor Dave Smith, a microbiologist at the University of Delaware, is one: "I'm certainly not saying they did or didn't do it. But you have to ask yourself, if you have five data points like that, what are the odds of that happening?"

• The Defense Department has rejected the evidence that the vaccine ever contained squalene. It has steadfastly contended that FDA technicians introduced squalene into the vaccine test via a "dirty fingerprint." The FDA has refused to explain its laboratory procedures for the tests. The military has never retested its stockpile of vaccine for squalene, claiming that, even if the amounts of squalene detected by the FDA were accurate, the concentrations were too low to affect human health. The department continues to require the vaccination for all military personnel - active duty, reserve and National Guard.

• Tulane University professor Robert Garry testified before Congress that even trace amounts of squalene injected into the human body suppress the immune system. In an interview with The News Journal, he said the body's response can cause some young and middle-age people to get illnesses normally associated with aging.

• Tulane University professor Pamela Asa and Baylor College of Medicine professor Dorothy Lewis have concluded that squalene's possible links to serious human illnesses should be studied further. The military has dismissed Asa's studies as inconclusive, although it has conducted no follow-up research on the health effects of squalene.

Troops' consent required

Military and international law expressly forbid experiments on troops without their informed consent. Federal law prohibits the testing of any drugs on human beings without approval by the Food and Drug Administration.

An estimated 1.9 million service members have received anthrax vaccine. Experts disagree widely over how many of them have experienced ill effects from the vaccine. Estimates range from 0.007 percent, or 13,000 people, by the Air Force to 84 percent, or 1.6 million people, by the GAO.

The military has generally refused to discuss details about the Dover vaccine that contained squalene. Air Force officials in Dover recently directed troops not to discuss their experiences with reporters. The News Journal spoke to dozens of Air Force pilots and crew members, but only a handful were willing to come forward publicly.

Military personnel said they were afraid they could face a court-martial for speaking publicly because it would violate an order to keep silent. Former military personnel, many of whom have taken jobs with commercial airlines, said they could lose their jobs if the extent of their illnesses became known.

Military spokespeople refer all inquiries to a Web site - called the Anthrax Vaccine Immunization Program or AVIP - that contains unsigned articles and information from unidentified sources. Civilian scientists such as Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said the Web site lacks scientific credibility.

The military says there is no link between squalene, the vaccine and the illnesses reported by servicemen and servicewomen. But military medical records of two Dover servicemen reviewed by The News Journal link all three, and some troops have received medical waivers from receiving future shots.

In February 2003, doctors at Walter Reed Army Medical Center wrote in a medical assessment of Senior Airman Daniel Tam of Dover: "We have recently encountered numerous service members who have precipitation and exacerbation of headache syndromes with concomitant receipt of the anthrax vaccine. The immunopathogenic mechanism has yet to be established."

Tam suffers from severe migraine headaches and has been placed on 100 percent military disability.

Some civilian experts say squalene suppresses the immune system so that people predisposed to specific illnesses can get sick years earlier than normal. Some young troops have reported illnesses usually seen by people in their 60s and 70s.

One Dover pilot, who received at least one injection with squalene, said he is able to function only by taking painkillers every day.

"Without my meds, I can't shower or feed myself. I'm non-functional," he said. "Without my meds, I curl up into a fetal ball."

Evidence of squalene

The FDA gave limited approval for the Defense Department to test vaccines boosted with squalene during the 1990s. The results of those tests are confidential. But the FDA has not given final approval for human use in the United States.

Asa voiced concerns about the possibility of squalene in anthrax vaccine as early as 1994. In August 1997, retired Vice Adm. Harold M. Koenig, then surgeon general of the Navy, said his office began receiving inquiries about the danger of the anthrax vaccine.

"I sent a request to the Army to ask for information, and they said there had been squalene in trace amounts in vaccines for a long, long time," Koenig said.

That same year, Asa and Tulane University researchers Yan Cao and Garry tested the blood of 56 patients, most suffering with symptoms, and found that most of the samples had antibodies - proteins produced by the immune system to fight harmful foreign substances - to squalene. Their research, published in February 2000 in the journal Experimental and Molecular Pathology, concluded that even trace amounts of squalene could cause autoimmune disorders.

Dover is ground zero

In April 1999, as word of Asa's work spread, Grieder asked the Pentagon to brief him and his pilots. The Air Force sent a lieutenant colonel to Dover, but the briefing wasn't well received.

"The guy made just ridiculous comments," Grieder said.

Retired Lt. Col. Jay Lacklen, one of Grieder's former pilots who attended the briefing, said, "At one point, responding to a question about the vaccine, this lieutenant colonel from the Pentagon told all of us, 'I don't know and I don't care.' "

Midway through the briefing, Grieder stood up, interrupted the Pentagon staffer and announced that he had decided to halt the anthrax vaccination program for all personnel under his command.

Grieder called his boss at the Pentagon to tell him what he had done. Grieder was called to Washington the next day to discuss his actions before a group of generals.

After hearing him out, the Air Force assembled a blue-ribbon panel of briefers, headed by Lt. Gen. Charles Roadman, then the surgeon general of the Air Force.

In May 1999, Roadman brought a team of civilian and military medical experts to Dover, including experts from the Army's Medical Research Institute of Infectious Diseases, the military's bio-weapons research center at Fort Detrick, Md.

Roadman began his briefing encouraging those packed into the room to trust the Air Force.

He then turned to the issue of squalene, the real reason for the packed room.

"Let me say this as succinctly as I can: There is not, there never has been squalene as an adjuvant in the anthrax immunization - period," said Roadman. He said two of the five batches sent to Dover had been tested and no squalene was detected.

Ten months after the briefing, the Army applied for a patent for a new way to make anthrax vaccine with squalene as an ingredient. The patent was granted two years later.

Smith, the UD microbiologist, reviewed the patent application for The News Journal and noted that squalene was a component. The purpose of the squalene was not explained in the patent.

"I guess I would be curious why they put squalene in there," Smith said.

The Army has refused to discuss the patent.

Vaccinations resume

After that presentation, Grieder allowed the anthrax vaccinations at the base to resume. Two months later he was transferred to an administrative job in Washington.

After Grieder's decision to allow the vaccinations to resume, 55 of the 120 pilots assigned to the reserve air wing at Dover quit rather than submit to the shots.

In October 2000, the FDA announced it had found squalene in all five batches of vaccine sent to Dover - the lots Roadman said were safe.

Grieder, who was already in a new job at the Pentagon and realizing that his Air Force career was over, said he knew then that he and his troops had been deceived. After retiring the following year, he has devoted himself to finding out why.

Now Grieder says he knows: "It appears illegal medical experiments were foisted upon us."

Experiments denied

Defense officials deny that personnel at Dover were subjected to illegal experiments.

"That's just wrong," said Roadman, who is now retired. "Unfortunately, you can have a disagreement where neither party is lying."

When pressed about Grieder's allegations, official spokespersons up and down the chain of command referred questions to others, refused to comment or issued blanket denials.

Maj. Cheryl Law, the public affairs chief at Dover Air Force Base, referred questions to the Defense Department. Law also sent an e-mail to every first-sergeant, group commander, squadron commander, public affairs officer and division chief on the base, warning them not to talk with a News Journal reporter.

Lt. Col. Frank Smolinsky, public affairs chief for the secretary of the Air Force, said the vaccine was safe and that he did not know whether experiments on troops took place. He referred further questions to the Air Force surgeon general.

Bettyann Mauger, the public affairs chief for the surgeon general, said no experiments occurred in Dover. She referred reporters to the Defense Department and the government's anthrax vaccination Web site.

Jim Turner, a civilian public affairs officer at the Defense Department, declined to comment. He also referred reporters to the government's anthrax vaccination Web site.

Col. John Grabenstein, deputy director of the Military Vaccine Agency, said of Grieder's allegations: "It is completely false. There were no medical experiments involving anthrax at Dover or anywhere else."

Contamination blamed

Aside from denying that an illegal experiment took place, military officials focus mainly on explanations of how squalene got into the vaccine shipped to Dover. Several blamed a dirty fingerprint they said somehow came in contact with the vaccine.

"The supposition is, squalene in the oil from a fingerprint was added through contaminated lab work," Grabenstein said. "I think that's the most logical explanation."

Dr. Tom Waytes, chief medical officer for the company that made the vaccine, said the minute levels of squalene found do not suggest that it was added to boost the effect of the vaccine.

"I believe it's more likely caused by contamination," said Waytes, who works for Michigan-based BioPort.

BioPort is the only firm that manufactures the anthrax vaccine for the U.S. government.

Waytes blamed the FDA for adding squalene to the vaccine during its testing process.

"BioPort never put squalene in the anthrax vaccine, and I'm not convinced there ever was squalene in the vaccine," Waytes said. "It's most likely caused by the testing process."

Several batches of vaccine produced by BioPort were first tested by Stanford Research Institute, a private firm not affiliated with Stanford University.

This testing did not detect squalene, but FDA tests did.

"The FDA came back using more sensitive tests, and found very minute amounts in the five different lots," Waytes said. "The fact that it could have been due to contamination has never been ruled out."

Lenore Gelb, a Washington D.C.-based spokeswoman for the FDA, declined to comment on BioPort's allegations. She referred reporters to the government's anthrax vaccination Web site, which blames the vaccine contamination on a fingerprint.

"The FDA notes that these minute quantities could have come from processing during FDA tests [squalene is present in the oil in fingerprints]," the Web site states.

Experts, including several civilian immunologists, scoffed at the fingerprint theory.

"It doesn't make sense," Caplan said. "I don't think the FDA is that sloppy."

Roadman, the former Air Force surgeon general, has said any squalene detected occurred naturally.

"As you know I haven't tried to explain this, but squalene is a naturally occurring chemical compound," Roadman said.

Roadman could not say how the squalene ended up in the vaccine sent to Dover.

"I can't tell you that," he said. "I don't know."

In fact, the military never launched an investigation of how squalene got into the vaccine.

Lacklen, a retired senior pilot who received the full program of anthrax inoculations in Dover, has spearheaded a drive to rebut the military's versions of events. He harbors no doubt that senior military officers experimented on him, his fellow pilots and his crews.

"They have squandered generations of trust and goodwill for a program that violated U.S. law and the Geneva conventions," Lacklen said. "They have jeopardized America's front-line troops, and therefore, the safety of the nation."

Health effects disputed

Regardless of how squalene may have gotten into the vaccine, military officials deny that it occurs in amounts that could cause harm.

The research of Asa, Cao and Garry - published four years ago, suggesting that even trace amounts of squalene could cause harm to humans - led Congress and other researchers to call for further study.

In a September 2000 letter to former U.S. Rep. Jack Metcalf, a Republican from Washington state who led a one-man investigation into the anthrax vaccination program, an immunologist said squalene should be studied as a possible factor in serious illnesses.

"The real question is whether squalene in parts per billion was added to the vaccine preparations given to the military, as well as whether this concentration of squalene could alter the immune response," wrote Dr. Dorothy Lewis, associate professor of immunology at the Baylor College of Medicine in Houston, Texas. "More research needs to be done to answer these questions, but it is possible that very small amounts of a biologically active product could induce an immune response, either to the molecule itself or it could boost immune responses to other agents in the mixture."

Lewis declined to comment about her letter.

Numerous studies on the effect of squalene on laboratory rodents suggest that the substance suppresses the immune system. The Defense Department has refused to release the results of human tests of vaccines boosted by squalene conducted in the 1990s.

Despite the official denials, some military physicians have concluded that the Dover vaccine harmed some servicemen and servicewomen.

The medical records of a Dover pilot, who feared for his career if his name was used in this story, show that several military physicians linked his advanced arthritis to the vaccine.

"The symptoms began after anthrax immunization, and are in line of duty," the records say. The pilot's records also reveal the presence of an antigen associated with autoimmune disorders.

Several members of the military brought their concerns to Congress in July 1999, during testimony before the House Committee on Government Reform's Subcommittee on National Security, Veterans Affairs and International Relations.

Capt. Michelle Piel was a C-5 Galaxy pilot stationed at Dover.

"All my life I've wanted to fly and serve my country to the best of my ability," she told the subcommittee.

Piel became ill after her first two injections with the vaccine. Her arm grew numb, the right side of her head filled with fluid, and she was grounded because of dizziness.

She testified the dizziness progressed to the point where she was unable to drive, read or concentrate. She was so tired she slept most of the day, and was unable to keep food down.

A total of 12 military and civilian physicians were unable to diagnose her illness. Months later, when a lump was removed from her breast, her symptoms worsened.

"There is no way that I know of to prove that the anthrax vaccine caused any of this," she told the subcommittee. "All I can say is that I became uncharacteristically ill after I started taking the anthrax shots."

Lt. Richard Rovet worked at Dover's Flight Medicine Clinic, where his duties included nursing, case management and patient advocacy.

Rovet described to the subcommittee the adverse reactions to the vaccine he had seen in patients at the clinic.

The symptoms included memory impairment, dizziness, ringing in the ears, joint pain, muscle pain, numbness in various parts of the body, miscarriage, cardiac problems, swollen testicles, hypothyroidism, chills, fever, rashes, photosensitivity and constant fatigue.

"We have been told time after time that the vaccine is entirely safe, yet there is a disparity between what we are told and what we are seeing," Rovet said.

The military's anthrax Web site claims the vaccine is safe, because "The Food and Drug Administration individually approves each lot before release."

But FDA documents obtained under the Freedom of Information Act show that the FDA no longer tests the lots for squalene.

Grabenstein said testing for squalene is not necessary.

"We have looked at 30 some lots, and found it at levels below the level in the human bloodstream," he said. (A lot includes 1.8 million doses of vaccine.) "It would achieve nothing in science to go looking for this chemical already in your bloodstream."

Calls for change ignored

That opinion was not shared by Rep. Metcalf, who conducted a three-year investigation into the anthrax vaccine.

Metcalf's investigation revealed "that squalene, a substance in unapproved adjuvant formulations, was found in the anthrax vaccine in amounts that could boost immune response - raising the possibility that squalene was used in inoculations given to Gulf War-era vets. GAO science investigators have documented concerns regarding the use of novel adjuvant formulations in vaccines, including squalene."

Metcalf, who is in ill health, was unable to comment.

Sens. Joe Biden and Tom Carper and Rep. Mike Castle, all of Delaware, would not comment about Col. Grieder's allegations. Through their respective spokespersons, they said they didn't know enough about Grieder's claims.

Metcalf's report cites Defense Department "stonewalling" and characterizations from GAO investigators that accused the Defense Department of instituting "a pattern of deception."

The GAO investigators reported a reluctance by the Defense Department to admit it had conducted five clinical trials with squalene, and had plans for one more.

"In fact, in most cases they only admitted to conducting research after we had discovered it in public records," Metcalf's report states. "On three occasions people attending the conference did not report their own research with squalene adjuvants."

Metcalf and the GAO found that the Defense Department experimented with adjuvants "to use fewer inoculations, get a better response and to check unconquered antigens."

In March 1999, the GAO presented its report and called on the Defense Department to conduct research that would reveal whether Gulf War veterans had squalene in their blood.

The department accused the GAO of being "scientifically and fiscally irresponsible."

Six months later, Metcalf sent a letter to then-Secretary of Defense William Cohen, calling on him to comply with the GAO recommendations. Metcalf also called on the Defense Department to track down the source of squalene in the vaccine.

The Defense Department never complied.

No legal option

The Uniform Code of Military Justice specifies that military personnel have no right to refuse a lawful order. Military judges have ruled that the order requiring service members to take the anthrax vaccine is lawful.

Phil Cave, a Virginia-based defense attorney, has represented three service members who have refused to take the anthrax vaccine.

"The issue of whether the Defense Department can do this is pretty well resolved by the courts," Cave said. "I have to tell them the law considers it a lawful order. If they refuse, they risk prosecution, discharge and jail."

Cave was successful at lessening the punishment in his three cases. Two received minor admonishments. One lost rank and pay.

Other personnel haven't been as lucky. Several anthrax refusers have received dishonorable discharges coupled with several months of confinement.

Many of the military personnel interviewed for this story said they were forced to choose between their health and their career. Cave said the likelihood of military punishment is significant for those who refuse vaccination. "I have to advise them it's in their best interests to take it."

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

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Military couple feel betrayed
'I'm 36 years old. I'm not supposed to be falling apart.'

By LEE WILLIAMS
The News Journal
10/10/2004

John Salzano and his wife, Tammy Hull, are proud to have devoted their lives to the U.S. Air Force.

They met seven years ago while serving at Dover Air Force Base, and married shortly thereafter. Salzano's daughter serves in the Air Force, as do many of the couple's friends.

Now, they feel their loyalty has been exploited.

Both have suffered since receiving anthrax vaccinations they were ordered to take - vaccines the Air Force promised were safe.

"I'm 36 years old," said Hull, a technical sergeant with 18 years of active-duty service. "I'm not supposed to be falling apart."

Minutes after receiving the first anthrax injection in 1998, Hull began having reactions: intense headaches coupled with muscle spasms throughout her upper body. She reported the "adverse reaction," an immediate onset of arthritis-like symptoms, and was sent to Walter Reed Army Medical Center in Washington, D.C.

Despite seeing the pain that daily wracked his wife's joints, Salzano, a member of the Air Force Reserve, willingly took the shots seven months later.

Salzano and Hull proudly note they have never disobeyed a direct order. And unlike the officers who got briefings from a three-star general - the surgeon general of the Air Force - when they questioned the safety of the vaccine, Hull said enlisted personnel were kept in the dark about potential health problems.

"All we were told was they had a new batch of anthrax vaccine and that they had gotten rid of the old batch because there was something wrong with it."

Salzano, a diabetic for 23 years, is now 51. He said he has monitored his diabetes well.

He's convinced that the vaccine aggravated his disease, which ultimately caused his kidneys to shut down. Now he undergoes dialysis three times a week.

"There's 27 chairs in the dialysis unit," he said. "I'm by far the youngest guy in there."

When doctors amputated half of his right foot last month, Salzano was medically retired from his civilian position at the base.

A distinguished career

Hull holds a supervisory position at that base.

She's the noncommissioned officer in charge of the air terminal at Dover Air Force Base - a senior enlisted position.

There are more than 60 people in her section. Next month, she's due for promotion to master sergeant.

Hull and Salzano are active in their church and their community. Salzano is commander of the 1,900-member American Legion Post No. 2 in Dover. Hull serves as the post's finance officer when she's not deployed overseas. The Air Force has sent her to Afghanistan, Saudi Arabia and Kuwait.

There's a world map tacked onto the wall of their garage. They use it to show friends and family where she's been deployed.

Hull, not Salzano, was referred by Dover Air Force Base to Walter Reed. Salzano remembers the first visit well.

"We saw all kinds of doctors there - civilian and military," Salzano recalled. "We were there all day."

A doctor, an Army lieutenant colonel, unofficially disclosed the root cause of Hull's problems, the couple said. They could not recall the doctor's name.

"She led us to believe, because of all the cases and symptoms she was seeing, it was all caused by the shot," Salzano said.

Added Hull: "In a round-about way, she told us she couldn't admit it, but that the problems were all caused by the shots. She said she was not permitted to tell us officially that all the problems were caused by the shot."

Others ignored Hull's complaints, they said.

"One doc said I was fine, but when you can't move, you're not fine," she said.

Hull's medical problems intensified after each anthrax shot. She continued filling out adverse reaction reports, though nothing was done with the documents. There was no follow-up care.

Before the fifth and sixth shots, Hull self-medicated with powerful muscle relaxants and painkillers. It was the only way she could physically cope with the intense pain caused by the vaccine.

Throughout the vaccination program, Hull's troops frequently questioned her about the vaccine.

"I told them they're supposed to take the shots," she said. "It was mandatory. Refusing wasn't an option."

Tests at Walter Reed continued - medical and psychological. One particularly painful neurological test still haunts the couple.

"They stuck needles in me, all over my body, like acupuncture," Hull recalled. "And then they electrified the needles."

At one point Hull was granted a temporary reprieve. A friendly doctor issued her a six-month medical waiver from the vaccination program.

"After six months, the deployment officer told me the waiver had expired, and I had to get the shots again," she said. She complied with the order.

Now, she blames the vaccine for causing permanent damage to her body.

Hull was recently diagnosed with arthritis in her knees and shoulders, but she knows her husband's problems are far worse.

The couple have strong feelings about former Dover commander Col. Felix Grieder's allegations of illegal experimentation on pilots and crew under his command. The military denies that it experimented on the troops.

"That sucks," Salzano said. "I have no respect for anyone who would do that. The way the military is today - it's a damn shame. It's shameful they have to experiment like that."

Said Hull: "I've never met anyone who was glad they got the shots."

What researchers found in blood samples

In 1997, researchers at Tulane University, in New Orleans, ran tests on blood samples from military patients, most suffering from Gulf War syndrome, to determine whether they had antibodies to squalene.

Squalene, a fat-like substance that humans produce naturally, can also be developed in laboratories and used as a booster to increase the effects of a vaccine. The Food and Drug Administration has not approved the use of squalene as a booster in vaccines.

Six patients who had Gulf War syndrome but were not deployed overseas had antibodies to squalene in the serum of their blood. All six had received the anthrax vaccine. The researchers concluded that the vaccine contained squalene.

Because the six had symptoms related to autoimmune diseases, researchers concluded that the antibodies were attacking not only the injected squalene but also the naturally occurring squalene in the organs.

Results of the study were published in February 2000 in the journal Experimental and Molecular Pathology. A follow-up study was published in the same journal in August 2002.

Dr. Pamela Asa, now a visiting professor at Tulane, led both studies. She said the military knowingly and illegally put squalene in the anthrax vaccine.

Other researchers have criticized the study - primarily because it used a novel technique to test for squalene antibodies. "You need to have a bona fide antibody agent that is recognizing squalene," said Dr. Alan Shaw, a Merck & Co. immunologist.

Dr. Robert Garry, who worked on the study with Asa, disagreed. "Just because it's a new method doesn't mean it doesn't work," he said.

- HIRAN RATNAYAKE

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

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Careers cut short after inoculations

By LEE WILLIAMS
The News Journal
10/10/2004

Even before squalene was discovered in the anthrax vaccine administered at Dover Air Force Base, the vaccine was suspected as a cause of health problems.

Dozens of Web sites and support groups are dedicated to linking autoimmune disorders to the shot. The vaccine has been the subject of several scientific studies that conclude it could be a factor in making soldiers sick.

Department of Defense officials say the vaccine is safe, with or without squalene. Thousands of troops have taken the vaccine with no ill effects. The military says it is normal for a small number of people to have a bad reaction to any vaccine.

"To the best of my knowledge, it's a safe vaccine," said former Air Force Surgeon General Charles Roadman. "It has certainly been controversial."