By
Timothy W. Maier


Executive
Order 13139 http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi://oma.eop.gov.us/1999/10/1/8 is
requiring military personnel to receive experimental vaccines not approved by
the Food and Drug Administration. Courts-martial are pending.


A
day after Republican Rep. Chris Shays of Connecticut ended congressional
hearings on the controversial decision mandating the inoculation of 2.4 million
U.S. troops against anthrax, President Clinton quietly signed an executive
order, or EO, that denies soldiers the right to refuse experimental vaccines.


EO13139,
titled “Improving Health Protection of Military Personnel Participating in
Particular Military Operations,” caught Congress off guard as it directed
the Pentagon to disregard the authority of the Food and Drug Administration, or
FDA. The order authorized use of experimental vaccines — those not approved by
the FDA and therefore illegal — to be administered to members of the armed
forces without informed consent.


Some
congressmen saw this as an attack by the president on the House Government
Reform subcommittee on National Security, Veterans Affairs and International
Relations, where testimony indicated the Pentagon had violated the FDA’s procedures
on how to administer the anthrax vaccine. Those hearings – as well as others
held by the full House Committee on Government Reform — had put the FDA on the
spot for letting the Pentagon disregard sensible FDA regulations. The Pentagon
wanted to administer the shots now and, as a result, long-range studies were
not conducted and an inadequate reporting system was set up to hide the large
number of adverse effects, critics charged.


As
a result of the unprecedented implementation of the vaccination program, more
than 1,000 troops are awaiting trial on a felony charge of refusing to obey,
hundreds more have left the armed forces and dozens have been prosecuted.


The
FDA’s failure to take a stand against the Pentagon has prompted a group of
concerned congressmen, led by Republican Rep. Walter Jones Jr. of North
Carolina, formally to complain to the agency. “The FDA didn’t do its
job,” says Jones, a member of the House Armed Services Committee.
“Our men and women are too valuable and they’re not going to be guinea
pigs.”


Jones,
who has asked the Pentagon’s inspector general to launch a probe into the
growing anthrax controversy, warns that Clinton’s executive order “might
encourage more men and women to get out of the military. I think Clinton did it
to give cover to what the DOD [or Department of Defense] is doing.” And
with the FDA having rolled over, Jones says, he is even more determined to
learn why the White House and the Pentagon doubled the contract of
Michigan-based BioPort Corp., which manufactures the vaccine, from $25.7
million to $49.8 million and at the same time reduced the volume to be
delivered by 2.3 million shots (see “Why BioPort Got a Shot in the
Arm,” Sept. 20).


The
Pentagon has claimed the inoculation protects against all anthrax strains, and
BioPort made the same claim to Insight — despite the fact that an experiment
at the Fort Detrick chemical and biological warfare center in Maryland using
guinea pigs showed nine of the 27 anthrax strains tested killed 50 percent of
the vaccinated subjects.


Kwai-Cheung
Chan, the director of the special studies and evaluations, national-security
and international-affairs division of the General Accounting Office, testified
before the House Government Reform Committee that there have been no studies to
“determine the optimum number of doses of the anthrax vaccine. Although
annual boosters are given, the needs for a six-shot regimen and annual booster
shots have not been evaluated.”


Chan’s
biggest criticism, however, involves the process in which the vaccine was made.
He notes the deficiencies that FDA identified in its February 1998 inspection.
“These fell into two categories: those that might affect only one or a
limited number of batches, and those that could compromise the safety and
efficacy of any or all batches.” The facility was as a result shut down in
early 1998. BioPort is addressing the processing problems, but the FDA has yet
to approve its laboratory to produce the controversial vaccine.


Meanwhile,
since Insight last reported on the anthrax vaccination, still more troops and
civilians have fallen ill after receiving the shots, according to the FDA. From
1990 to Oct. 1, 1999, 425 reports of adverse events associated with the anthrax
vaccine have been reported. Critics argue the incidents are being underreported
because, unless the side effects involve chills or fatigue, some doctors say
they can’t report the symptoms (see “A Dose of Reality,” Sept. 20).


Mark
Zaid, an attorney representing dozens of troops who refused to take the
mandatory anthrax inoculation, says, “There are big problems. Why, all of
a sudden out of nowhere, especially when the opposition to the program is
getting so much steam and criticism of the Department of Defense was running
rampant, does Clinton sign an executive order that assures DOD can implement
any experimental program it wants? This whole thing is DOD doing an end run
around the FDA. The FDA should step up to plate and do its job.”


The
FDA may be starting to take note, according to a September letter from the
agency obtained by Insight. The letter was written the day Shays’ hearing
ended. Katheryn Zoon, director of the Center for Biologics Evaluation and
Research, wrote to Assistant Secretary of Defense Sue Bailey:


“Recently
it has come to the agency’s attention through congressional sources that some
troops may not be receiving the vaccine in accordance with the schedule found
in the approved labeling. As you know, the approved anthrax labeling states
that full immunization involves six doses of the vaccine to be administered
following the first dose at two and four weeks, six months, 12 months and 18
months, with yearly boosters thereafter. This schedule is the only regimen
shown to be effective in protecting humans against anthrax and is the only
schedule approved by the FDA. Data received by FDA from congressional sources
indicate that a number of reserve and active military personnel are receiving
their anthrax vaccine dose significantly later than the FDA approved
schedule.”


In
his order Clinton calls attention to the biological threat to which troops
might be subjected, saying soldiers could “potentially be exposed to a
range of chemical, biological and radiological weapons, as well as disease
endemic to an area of operations.” Defense Secretary William Cohen warned
recently on ABC’s Nightline that it is not a question of whether we could face
a biological attack, it’s a question of when.


But
neither the president’s top intelligence expert in this field nor the State
Department are impressed by these claims. Richard Clarke, the bioterrorism
expert with the National Security Council, also said on Nightline that he
doesn’t expect terrorists will turn to biological weapons. “I don’t
believe it’s a certainty at all,” he said. “I know that there are
people who say it will eventually happen. But I think you have to remember,
there has to be motivation. Someone has to do it. And that someone has to
believe they can get away with it. They’re not going to. If you look at our
history in the last five years, after every major terrorist incident we have
discovered the people who were involved. And even if they were on the other
side of the earth, and even if it was four years later or 10 years later, we
reached out and got them.”


In
addition, the State Department has posted this statement on its Website:
“The Department of State has no information to indicate that there is a
likelihood of use of chemical or biological agent release in the immediate
future. The Department believes the risk of the use of chemical/biological
warfare is remote, although it cannot be excluded.”


Meanwhile,
even though U.S. embassies are prime targets of terrorists, the State
Department isn’t requiring its employees to have the anthrax shot before
deployment. Jones called on the State Department to explain why it was not
mandating the shot, and promptly was told it will take “four years to get
that information.” He then turned to House International Relations
Committee Chairman Ben Gilman of New York, who quickly fired off a letter to
State demanding action.


Yet
Clinton signed EO13139 to use experimental vaccines on U.S. troops despite the
scandals created by exposure of the secret use of experimental vaccines ranging
from administering LSD in the 1950s to the drug pyriostigmine bromide, or PB,
given to troops bound for the Persian Gulf War. PB, which protects against
nerve gas, may be linked to some of the gulf-war illnesses, according to the
Rand Corp., a California-based think tank that recently published a 385-page
review of the drug.


Maj.
Thomas “Buzz” Rempfer of the Air Force Reserve says there may be
times when use of vaccines that have not been fully tested and FDA-approved may
be necessary and appropriate during great crisis. “But this capability for
our president is currently being jeopardized by the reckless mandatory
vaccination of all service members against anthrax,” he says. “The
threat is not imminent and the integrity of the military institution is being
compromised to implement a strategic or blanket program that is doctrinally
unprecedented and unsound. The lack of trust we are breeding in the force today
could sacrifice our military’s capability to protect our troops on a tactical
basis when threatened in the future.”


Link
: http://www.fibrom-l.org/experiments.htm


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