Sunday, October 10, 2004

Troops Used as 'Guinea Pigs' in Vaccination Program

Ex-DAFB commander says troops used as guinea pigs
The Delaware News Journal | October 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."