Ex-DAFB commander says troops used as guinea pigs
By LEE WILLIAMS and HIRAN RATNAYAKE
The News Journal
Military denies that illness of pilots, crew caused by squalene. 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."
The News Journal
Military denies that illness of pilots, crew caused by squalene. 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."
