| JWissmille 2004-10-24, 2:08 am |
| http://www.delawareonline.com/newsj...bcommander.html
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."
Contact investigative reporter Lee Williams at 324-2362 or
lwilliams@delawareonline.com. Contact Hiran Ratnayake at 324-2547 or
hratnayake@delawareonline.com.
The News Journal/GARY EMEIGH
Tammy Hull and her husband, John Salzano, blame their ill health on the
vaccine they were ordered to take.
Special to The News Journal/J. MICHAEL SHORT
Col. Felix Grieder, former commander at Dover Air Force Base, took the
drastic step of halting the vaccination program in Dover, a move he said ended
his
military career.
Lt. Col. Jay Lacklen is convinced that squalene in the anthrax vaccine is
responsible for the lumps on the joints of his fingers. He fights constant
pain.
Retired Vice Adm. Harold M. Koenig
Lt. Gen. Roadman
THE SQUALENE ISSUE
• In 1998, the Pentagon directs that military personnel be given anthrax
vaccine.
• In 1999, Col. Felix Grieder, Dover Air Force Base commander, temporarily
halts the vaccinations at the base over safety concerns.
• In 2000, first evidence emerges to suggest anthrax vaccine contains
squalene.
• Today, Grieder and others accuse the military of using them as guinea pigs.
SQUALENE TIMELINE
MAY 1881 - Louis Pasteur develops anthrax vaccine for sheep.
1954 - Anthrax vaccine developed for humans.
NOVEMBER 1973 - Food and Drug Administration publishes standards for making,
using and storing anthrax vaccine.
SEPTEMBER 1988 - Army contracts for anthrax vaccine with the only licensed
manufacture - the state-owned facility in Lansing, Mich., known as Michigan
Biologic Products Institute.
AUGUST 1997 - Vice Adm. Harold Koenig, former surgeon general of the Navy,
announces that squalene had been used as a vaccine booster by Department of
Defense since 1987.
1997 - Dr. Pamela Asa, who has been voicing concerns about squalene being
used as a booster in the anthrax vaccine, begins a study with researchers at
Tulane University, in New Orleans. They want to determine whether patients
suffering from Gulf War syndrome have antibodies to squalene in their blood.
MAY 1998 - Secretary of Defense William Cohen signs directive requiring
anthrax vaccine for all active and reserve Armed Forces members over seven
years.
It is known as the Anthrax Vaccine Immunization Program.
SEPTEMBER 1998 - AVIP officially begins.
The state of Michigan sells its anthrax production facility to BioPort Corp.
BioPort Corp. signs a $29 million contract with the military to produce the
anthrax vaccine.
MAY 1999 - Vanity Fair publishes article claiming military is illegally
experimenting on its soldiers by putting squalene in anthrax vaccine.
MAY 1999 - Dover Air Force Base commander, Col. Felix Grieder, halts anthrax
vaccination program on his air base.
MAY 1999 - Gen. Charles Roadman tells Dover Air Force Base personnel that the
anthrax vaccine does not contain squalene.
MAY 1999 - Stanford Research International is hired by the government to
examine whether there is squalene in the anthrax vaccine. It finds none.
FEBRUARY 2000 - Asa's study, titled "Antibodies to Squalene in Gulf War
Syndrome," is published in the journal Experimental and Molecular Pathology.
MARCH 2000 - The Army applies for anthrax vaccine patent that includes
squalene.
JUNE 2000 - Letter published in Experimental and Molecular Pathology from
Col. Carl Alving, a military doctor, slams method used in the Asa study.
SEPTEMBER 2000 - Department of Defense becomes aware of FDA test results
finding traces of squalene in lots tested at Dover Air Force Base.
OCTOBER 2000 - A General Accounting Office study finds that a quarter of all
176,000 pilots and other flight crew members in the Air Force Reserve and Air
National Guard have resigned or transferred out of their units in the past
year. The loss of personnel is blamed on suspicions about the anthrax vaccine.
MAY 2002 - U.S. Patent Office approves Army's patent application.
AUGUST 2002 - Second study by Asa on squalene antibodies in patients
suffering from Gulf War syndrome is published in Experimental and Molecular
Pathology.
OCTOBER 2002 - FDA halts use of some vaccines manufactured by BioPort because
they were not tested properly for safety and effectiveness.
DECEMBER 2003 - Federal judge bans Pentagon from forcing all service members
to get the anthrax vaccine.
JANUARY 2004 - Judge lifts temporary injunction on vaccine after FDA issues a
formal rule saying vaccine is safe.
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