THE FAUCI FILES, Vol 3( 9): Clinton's Brave New World of Human
Experimentation, Executive Order # 13139
January 20, 2000
The military has admitted, as best it can, that pyridostigmine bromide
is the most likely cause of Gulf War Syndrome. While soldiers were
ordered to take this drug in anticipation of Iraq's Saddam Hussein
using nerve gas, the problem remains obvious: this drug, like the
anthrax vaccine, was never tested nor monitored for safety.
Why did the military take nearly a decade to figure out the cause
of Gulf War Syndrome when it was known ALL ALONG that the ONLY
ones who suffered Gulf War Syndrome were ALSO the ones who took
pyridostigmine bromide?
Hint: of the many countries who sent their soldiers to the Gulf War,
only the U.S. soldiers were given this experimental and untested
drug -- pyridostigmine bromide -- these were the ones who
came back with GWS. Of course, the sufferers of GWS were lied to
when told their diseases were "psychological" or that their
diseases were consistent with the general population disease
trends).
This answers the question: "Do government doctors lie?"
Upon learning of the military human experiment "issues", The "Ethics
President", William Jefferson "I feel your pain" Clinton, rushed
out Executive Order 13139, formalizing the "need" to use military
personnel for human experiments involving drugs and vaccines that
have NOT been approved for safety or efficacy by the Food and Drug
Administration.
Clinton's vision of a "Brave New World" of human experimentation
remains 100% consistent with the trend of human experiments pursued
by the National Institutes of Health, and especially the
pathogen-based experiments of the worst of the worst,
Dr. Anthony "Mussolini" Fauci, the diminutive Dictator-Direktor
of the National Institute of Allergy and Infectious Diseases,
who is ALSO the bureaucrat assigned responsibility for ALL vaccines,
including the scandal-plagued anthrax vaccine.
One might suppose that Dr. Fauci was too busy getting rich
on his own fraudulent IL-2 patent while directing dozens of
taxpayer-funded DEADLY IL-2 human experiments that have led
to thousands of deaths nationwide. So what's the big deal
with GWS and the anthrax vaccine scandal, eh Dr. Toni?
W. Fred Shaw
------------
THE WHITE HOUSE
Office of the Press Secretary
________________________________________________________________________
For Immediate Release September 30, 1999
EXECUTIVE ORDER
- - - - - - -
IMPROVING HEALTH PROTECTION OF MILITARY
PERSONNEL PARTICIPATING IN PARTICULAR MILITARY OPERATIONS
By the authority vested in me as President by the Constitution and
the laws of the United States of America, including section 1107 of
title 10, United States Code, and in order to provide the best health
protection to military personnel participating in particular military
operations, it is hereby ordered as follows:
Section 1. Policy. Military personnel deployed in particular
military operations could potentially be exposed to a range of chemical,
biological, and radiological weapons as well as diseases endemic to an
area of operations. It is the policy of the United States Government to
provide our military personnel with safe and effective vaccines,
antidotes, and treatments that will negate or minimize the effects of
these health threats.
Sec. 2. Administration of Investigational New Drugs to Members of
the Armed Forces.
(a) The Secretary of Defense (Secretary) shall collect intelligence
on potential health threats that might be encountered in an area of
operations. The Secretary shall work together with the Secretary of
Health and Human Services to ensure appropriate countermeasures are
developed. When the Secretary considers an investigational new drug or
a drug unapproved for its intended use (investigational drug) to
represent the most appropriate countermeasure, it shall be studied
through scientifically based research and development protocols to
determine whether it is safe and effective for its intended use.
(b) It is the expectation that the United States Government will
administer products approved for their intended use by the Food and Drug
Administration (FDA). However, in the event that the Secretary
considers a product to represent the most appropriate countermeasure for
diseases endemic to the area of operations or to protect against
possible chemical, biological, or radiological weapons, but the product
has not yet been approved by the FDA for its intended use, the product
may, under certain circumstances and strict controls, be administered to
provide potential protection for the health and well-being of deployed
military personnel in order to ensure the success of the military
operation. The provisions of 21 CFR Part 312 contain the FDA
requirements for investigational new drugs.
Sec. 3. Informed Consent Requirements and Waiver Provisions.
(a) Before administering an investigational drug to members of the
Armed Forces, the Department of Defense (DoD) must obtain informed
consent from each individual unless the Secretary can justify to the
President a need for a waiver of informed consent in accordance with 10
U.S.C. 1107(f). Waivers of informed consent will be granted only when
absolutely necessary.
(b) In accordance with 10 U.S.C. 1107(f), the President may waive the
informed consent requirement for the administration of an
investigational drug to a member of the Armed Forces in connection with
the member's participation in a particular military operation, upon a
written determination by the President that obtaining consent:
(1) is not feasible;
(2) is contrary to the best interests of the member; or
(3) is not in the interests of national security.
(c) In making a determination to waive the informed consent
requirement on a ground described in subsection (b)(1) or (b)(2) of this
section, the President is required by law to apply the standards and
criteria set forth in the relevant FDA regulations, 21 CFR 50.23(d). In
determining a waiver based on subsection (b)(3) of this section, the
President will also consider the standards and criteria of the relevant
FDA regulations.
(d) The Secretary may request that the President waive the informed
consent requirement with respect to the administration of an
investigational drug. The Secretary may not delegate the authority to
make this waiver request. At a minimum, the waiver request shall
contain:
(1) A full description of the threat, including the potential
for exposure. If the threat is a chemical, biological, or
radiological weapon, the waiver request shall contain an
analysis of the probability the weapon will be used, the
method or methods of delivery, and the likely magnitude of its
affect on an exposed individual.
(2) Documentation that the Secretary has complied with 21 CFR
50.23(d). This documentation shall include:
(A) A statement that certifies and a written
justification that documents that each of the criteria
and standards set forth in 21 CFR 50.23(d) has been met;
or
(B) If the Secretary finds it highly impracticable to
certify that the criteria and standards set forth in 21
CFR 50.23(d) have been fully met because doing so would
significantly impair the Secretary's ability to carry out
the particular military mission, a written justification
that documents which criteria and standards have or have
not been met, explains the reasons for failing to meet
any of the criteria and standards, and provides
additional justification why a waiver should be granted
solely in the interests of national security.
(3) Any additional information pertinent to the Secretary's
determination, including the minutes of the Institutional
Review Board's (IRB) deliberations and the IRB members'
voting record.
(e) The Secretary shall develop the waiver request in consultation
with the FDA.
(f) The Secretary shall submit the waiver request to the President
and provide a copy to the Commissioner of the FDA (Commissioner).
(g) The Commissioner shall expeditiously review the waiver request
and certify to the Assistant to the President for National Security
Affairs (APNSA) and the Assistant to the President for Science and
Technology (APST) whether the standards and criteria of the relevant FDA
regulations have been adequately addressed and whether the
investigational new drug protocol may proceed subject to a decision by
the President on the informed consent waiver request. FDA shall base
its decision on, and the certification shall include an analysis
describing, the extent and strength of the evidence on the safety and
effectiveness of the investigational new drug in relation to the medical
risk that could be encountered during the military operation.
(h) The APNSA and APST will prepare a joint advisory opinion as to
whether the waiver of informed consent should be granted and will
forward it, along with the waiver request and the FDA certification to
the President.
(i) The President will approve or deny the waiver request and will
provide written notification of the decision to the Secretary and the
Commissioner.
Sec. 4. Required Action After Waiver is Issued.
(a) Following a Presidential waiver under 10 U.S.C. 1107(f), the DoD
offices responsible for implementing the waiver, DoD's Office of the
Inspector General, and the FDA, consistent with its regulatory role,
will conduct an ongoing review and monitoring to assess adherence to the
standards and criteria under 21 CFR 50.23(d) and this order. The
responsible DoD offices shall also adhere to any periodic reporting
requirements specified by the President at the time of the waiver
approval.
The Secretary shall submit the findings to the President and provide a
copy to the Commissioner.
(b) The Secretary shall, as soon as practicable, make the
congressional notifications required by 10 U.S.C. 1107(f)(2)(B).
(c) The Secretary shall, as soon as practicable and consistent with
classification requirements, issue a public notice in the Federal
Register describing each waiver of informed consent determination and a
summary of the most updated scientific information on the products used,
as well as other information the President determines is appropriate.
(d) The waiver will expire at the end of 1 year (or an alternative
time period not to exceed 1 year, specified by the President at the time
of approval), or when the Secretary informs the President that the
particular military operation creating the need for the use of the
investigational drug has ended, whichever is earlier. The President may
revoke the waiver based on changed circumstances or for any other
reason. If the Secretary seeks to renew a waiver prior to its
expiration, the Secretary must submit to the President an updated
request, specifically identifying any new information available relevant
to the standards and criteria under 21 CFR 50.23(d). To request to
renew a waiver, the Secretary must satisfy the criteria for a waiver as
described in section 3 of this order.
(e) The Secretary shall notify the President and the Commissioner if
the threat countered by the investigational drug changes significantly
or if significant new information on the investigational drug is
received.
Sec. 5. Training for Military Personnel. (a) The DoD shall provide
ongoing training and health risk communication on the requirements of
using an investigational drug in support of a military operation to all
military personnel, including those in leadership positions, during
chemical and biological warfare defense training and other training, as
appropriate. This ongoing training and health risk communication shall
include general information about 10 U.S.C. 1107 and 21 CFR 50.23(d).
(b) If the President grants a waiver under 10 U.S.C. 1107(f), the DoD
shall provide training to all military personnel conducting the waiver
protocol and health risk communication to all military personnel
receiving the specific investigational drug to be administered prior to
its use.
(c) The Secretary shall submit the training and health risk
communication plans as part of the investigational new drug protocol
submission to the FDA and the reviewing IRB. Training and health risk
communication shall include at a minimum:
(1) The basis for any determination by the President that
informed consent is not or may not be feasible;
(2) The means for tracking use and adverse effects of the
investigational drug;
(3) The benefits and risks of using the investigational drug;
and
(4) A statement that the investigational drug is not approved
(or not approved for the intended use).
(d) The DoD shall keep operational commanders informed of the overall
requirements of successful protocol execution and their role, with the
support of medical personnel, in ensuring successful execution of the
protocol.
Sec. 6. Scope. (a) This order applies to the consideration and
Presidential approval of a waiver of informed consent under 10 U.S.C.
1107 and does not apply to other FDA regulations.
(b) This order is intended only to improve the internal management of
the Federal Government. Nothing contained in this order shall create
any right or benefit, substantive or procedural, enforceable by any
party against the United States, its agencies or instrumentalities, its
officers or employees, or any other person.
WILLIAM J. CLINTON
THE WHITE HOUSE,
September 30, 1999.
# # #
