Back to Bioshield II

November 15, 2005

Colonel Robert P. Kadlec, M.D. (USAF, ret.)

Staff Director

Subcommittee on Bioterrorism

and Public Health Preparedness

United States Senate

217 Russell Senate Office Building

Washington, D.C. 20510-3306

Dear Colonel Kadlec:

Thank you for your call to the National Vaccine Information Center (NVIC)¹last week to discuss the intent of the Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S.1873, aka "BioShield II") sponsored by Senator Richard Burr (R-NC). I appreciated the opportunity to briefly discuss our reaction to the bill. I also appreciate your interest in, and consideration of, the enclosed concerns as well as your offer to meet to discuss these issues in the near future.

In short, we object to S.1873 because it: (1) lacks transparency into the research, development, licensure and post-licensure surveillance of biodefense vaccines and drugs; (2) lacks accountability for either manufacturers of these products or government health officials who mandate their use without informed consent; and, (3) lacks justice for those who will inevitably die or suffer chronic illnesses after being compelled to take these products.²This letter will review biodefense policy developments since 9/11, and the attachment will provide some suggested changes to BioShield Act provisions that would begin to address NVIC’s concerns.

As I mentioned in our telephone conversation, the NVIC has been monitoring vaccine development, regulation, legislation, policymaking and promotion for the past 23

^{1 www.nvic.org

^{2 See: Institute of Medicine, Sox, et.al.
(2000): "...Genetic inheritance strongly influences the immune response, both to
immunization and to actual infection (Box 7.1), in animals and humans,
which explains why immunologically mediated adverse reactions to vaccination are
so variable from one animal, or person, to the next." http://books.nap.edu/books/030907178X/html/272.html

years. We are a non-profit, educational organization and our
mission has always been to prevent vaccine injuries and deaths through public
education while defending the informed consent rights of citizens. Therefore, we
have been especially vigilant in monitoring state and federal legislation
related to the safety and effectiveness of vaccines released for public use, as
well as the ability of citizens to make informed, voluntary vaccination
decisions for themselves and their children. NVIC worked closely and
collaboratively with Congress, the vaccine manufacturers, and physician
organizations to create and promote passage of the National Childhood Vaccine
Injury Act of 1986.
Since September 11, 2001, we have been concerned that state and
federal biodefense legislation, including BioShield II, has been created and
promoted by the pharmaceutical industry and federal health officials with
virtually no input from average citizens whose lives will be impacted by this
legislation.³These new laws have eroded the ability of citizens to
make fully informed, voluntary vaccination decisions for themselves and their
minor children in the event the Secretary of the Department of Health and Human
Services (DHHS) declares a "potential or actual public health emergency"and the
Governors of states follow suit.
In your previous capacity as the director of biodefense
preparedness at the White House and a strategist who worked on national smallpox
vaccine policies, I am sure you are familiar with both the new federal laws⁴as well as the Model State Emergency Health Powers Act (MSEHPA). Given
your significant role in post-9/11 biodefense planning, I was surprised when you
stated that citizens could not be compelled to take biodefense countermeasures
developed under the BioShield Act, as amended by S. 1873. The White House has
been planning for martial law in response to bioterrorism for several years.⁵
3 For example, the current BioShield II
legislation was based on the recommendations of self-selected industry and
government "experts" contained in a 200+ page report sponsored by the
Pharmaceutical Research and Manufacturers Association. The report was prepared
by a think-tank – CBACI -- that apparently no longer exists. See: "Meeting
the Biodefense Challenge: A "Roadmap" for a National Vaccine Strategy",
Report of the CBACI National Vaccine Strategy Working Group, Chemical and
Biological Arms Control Institute, September 2004. (CBACI website no longer
online). See also, Washington Times, Oct 13, 2004: http://washingtontimes.com/upi-breaking/20041013-102231-7074r.htm

^{4 See:

-- Project BioShield Act of 2004 -
Public Law No: 108-276 [GPO: Text, PDF]

-- Smallpox Emergency Personnel Protection Act of 2003 -- Public
Law No: 108-20 [GPO: Text, PDF]
-- Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (aka Bioterrorism Act of 2002) - Public Law No: 107-188
[GPO: Text, PDF]
-- Homeland Security Act of 2002 - Public Law No: 107-296 [GPO:
Text, PDF]
^{5 In late 2002, General Wayne Downing, USA
(ret.), former White House Deputy National Security Advisor for
Counterterrorism, stated:

"The United States may have to declare martial law someday
in the case of a devastating attack with weapons of mass destruction causing
tens of thousands of casualties. This could mean that the military would be
given the authority to impose curfews, protect businesses and communities,
even make arrests." See: B. Gellman, "In U.S., Terrorism's Peril
Undiminished", Washington Post, Dec 24, 2002

http://www.washingtonpost.com/ac2/wp-dyn?pagename=article&node=&contentId=A31589-2002Dec23&notFound=true

2
The MSEHPA⁶, which was commissioned by the Centers
for Disease Control (CDC) long before September 11, 2001 and was expeditiously
presented to states in the wake of the anthrax letter attacks, has been passed
in one form or another by 37 states. The impetus for these laws to be passed
quickly in states was the warning from government officials that acts of
bioterrorism, especially using the weaponized smallpox virus, were imminent.
Because vaccine and other public health laws constitutionally fall with the
jurisdiction of states, it was necessary for federal health officials to ensure
that state health officials are legally in a position to work with Governors to
carry out a directive from the Secretary of Health and Human Services declaring
a "potential or actual" public health emergency. Under the MSEPHA, state public
health laws pertaining to emergencies involving infectious pathogens were
strengthened and gave expanded authority to public health and other government
officials. Under this legislation, Governors may declare an emergency and use
the "state militia" to take control of all roads leading into and out of cities
and the state; seize citizens' personal property without compensation; and
arrest, detain and forcibly examine, vaccinate and medicate citizens and their
minor children without informed consent, and not be held liable if these actions
result in the death or injury of citizens.
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002⁷(Public Law 107-188) was proposed soon after
the post-9/11 anthrax letter attacks began. This law enacted proposed changes to
vaccine and drug licensure standards that Congress had declined to pass since
FDA first proposed them in October 1999. ⁸Section 123 of
this law, known as the "animal efficacy rule," lowered biodefense vaccine and
drug licensure standards by allowing efficacy to proven by clinical trials in
one or more animal models, rather than in humans.⁹
This means that biodefense countermeasures licensed under the BioShield
Act, although billed by FDA as "fully licensed" (and therefore exempt from
informed consent requirements), will be unproven in humans until they are used
in mandatory mass immunization programs. Therefore, the risk-benefit analysis of
these products, mandated by the Food Drug and Cosmetic Act since 1962, will be
unknown.
The Homeland Security Act of 2002 (Public Law 107-296), like the
MSEHPA in state legislatures, was passed in Congress after warnings by DHHS and
DOD officials that there was a high probability that bioterrorist acts would be
carried out against the
^{6 http://www.publichealthlaw.net/Resources/Modellaws.htm#MSEHPA

^{7 http://www.fda.gov/oc/bioterrorism/bioact.html

^{8 Testimony of William Raub, DHHS Deputy
Assistant Secretary For Science Policy, before the Subcommittee on National
Security, Veterans Affairs and International Relations, Committee on Government
Reform Nov 9, 1999. See: http://www.fda.gov/ola/1999/newdrugs.html

^{9 67 Fed. Reg. 37988-37998 (May 31, 2002).
See also:

http://www.fda.gov/bbs/topics/NEWS/2002/NEW00811.html

3
U.S. population using the weaponized smallpox virus. As plans
were underway to pull old smallpox vaccine supplies out of warehouses where they
had been stored for 25 years and create enough vaccine to vaccinate most
Americans, vaccine manufacturers asked Congress to protect them from liability
from all lawsuits for smallpox vaccine injuries and deaths.
Section 304 of the Homeland Security Act gave the Secretary of
Health and Human Services authority to "issue a declaration concluding that an
actual or potential bioterrorist incident or other actual or potential public
health emergency makes advisable the administration of a covered countermeasure
to a category or categories of individuals" and "shall specify in such
declaration the substance or substances that shall be considered covered
countermeasures for purposes of administration to individuals." The Act removes
liability for injuries or deaths caused by the smallpox vaccine when it is used
as a "countermeasure," including protecting the pharmaceutical companies
producing smallpox vaccine and public health officials, doctors and others
administering the vaccine to citizens.
The Smallpox Emergency Personnel Protection Act of 2003 (Public
Law 108-20)¹⁰provided limited federal compensation for health care
workers and citizens who either administered or were given smallpox vaccine used
as a countermeasure during an "actual or potential emergency" declared by the
Secretary of DHHS. The compensation scheme was modeled after the vaccine injury
compensation program (VICP) created under the National Childhood Vaccine Injury
Act of 1986.¹¹However, unlike the VICP, in the smallpox vaccine
injury compensation scheme, the Secretary of Health and Human Services solely
determines the procedures for compensation and who will be compensated for their
vaccine injuries.
Of the 439,000 U.S. health care workers whom the Secretary asked
to voluntarily get smallpox vaccine in order to prepare for a possible
bioterrorist attack, over 90 percent refused¹²for three reasons: (1)
the bioterrorist threat was only hypothetical despite attempts by DHHS and DoD
to convince the public otherwise; (2) the smallpox vaccine in stockpiles was
known to be highly reactive;^{13 14}and (3) the federal compensation

^{10 http://www.hrsa.gov/smallpoxinjury/pl10820.htm

^{11 Public Law 99-660. See also: http://www.hrsa.gov/osp/vicp/qanda.htm

^{12 "U.S. Smallpox Official Acknowledges
Vaccination "Targets Were Not Achieved" ", Global Security News, Oct 22, 2003.
http://www.nti.org/d_newswire/issues/2003/10/22/a24c7520-4663-444d-88ec-a621cb131645.html

^{13 In 2001, the World Health Organization
recommended against mass smallpox immunization because of the known high
reactogenicity of the existing smallpox vaccine. These risks were first
identified in a study of Finnish military recruits in the 1980s, but were
ignored by US government public health officials in 2002-2003. See:

http://www.nti.org/d_newswire/issues/2001/10/26/8s.html
^{14 "Experts Say Civilian Smallpox Shots Not
Needed", Global Security News, Aug 9, 2004. http://www.nti.org/d_newswire/issues/2004/8/9/b077d25f-e6a9-49b9-9b1d-4325001b4f02.html

4
scheme¹⁵was less fair or generous than the VICP
(which turns two out of three vaccine victims away). Due to subsequent deaths
and life-threatening illnesses associated with the Wyeth smallpox vaccine
(mostly among military personnel¹⁶compelled to take the vaccine
under threat of court-martial), the product label now contains a black box
warning¹⁷about potentially fatal dangers to the heart.
The Bush Administration’s 2003 smallpox immunization program
ultimately failed so completely that the CDC director even attempted to disavow
its existence.¹⁸The unnecessary deaths and illnesses that resulted
from this ill-conceived plan should have served as a caution to those in
government who seek to mandate unsafe vaccines to protect against hypothetical
threats. Unfortunately, the BioShield II legislation indicates that government’s
lesson learned was simply that it needed to operate in greater secrecy and to
insure zero accountability – from pharmaceutical manufacturers or politicians –
the next time.
Congress subsequently passed the Project Bioshield Act of 2004
(Public Law 108-276), ostensibly to implement lessons learned from both the
smallpox and military anthrax immunization programs. Under the Bioshield Act,
the Secretary of Health and Human Services was given expanded authority to:

• institute "expedited peer review procedures" to prove that
experimental vaccines and drugs used as countermeasures are safe and
effective.

• declare an emergency based on either an actual or "potential"
threat, based on intelligence that may remain secret and not subject to
judicial review

• have FDA issue an "Emergency Use Authorization" (EUA)
describing the manner by which state authorities and DoD may use biodefense
vaccines and drugs on citizens.

These BioShield authorities have already been abused. On January
14, 2005 former Secretary of Health and Human Services Tommy Thompson declared¹⁹an anthrax threat emergency under the Bioshield Act in the absence of any
credible threat
^{15 http://www.hrsa.gov/smallpoxinjury/

^{16 "Military Personnel Suffer More Heart
Troubles Than Expected After Smallpox Vaccinations, Researcher Says", Global
Security News, May 13, 2004. See:
http://www.nti.org/d_newswire/issues/2004/5/13/2720eb81-1e4b-4850-a4df-f851533e3aa4.html

^{17
http://www.fda.gov/cber/products/smalwye101105.htm

^{18 "CDC Director Denies Existence of U.S.
Smallpox Immunization Program", Global Security News, Nov 18, 2003.
http://www.nti.org/d_newswire/issues/2003/11/18/1e571176-df2a-49c6-aa55-9fc7dcf53385.html

^{19
http://www.fda.gov/OHRMS/DOCKETS/98fr/dhhs-oc0523-let0001.pdf

5
information.²⁰This emergency was declared to
circumvent a federal court injunction against the Pentagon ordering that
military personnel be given the right to informed consent prior to being
administered the improperly licensed, experimental Bioport anthrax vaccine.²¹The FDA commissioner subsequently issued an emergency use authorization
that specifically allowed DoD to deny informed consent to servicemembers who
volunteered to take anthrax vaccine.²²}
According to arguments by Department of Justice attorneys in
federal court,²³the factual basis for the Secretary's anthrax
emergency declaration is not reviewable by either the Congress or the judicial
branch of government. This means that mandatory mass vaccination of the American
people with untested vaccines and drugs could be based on questionable threat
intelligence, just as the true facts underlying questionable weapons of mass
destruction (WMD) threat assertions used to justify the war with Iraq were never
disclosed to the people.
Unfortunately, the once mandatory DoD anthrax vaccine program --
exemplified by a DoD-FDA cover-up of deaths and illnesses²⁴
associated with the BioPort anthrax vaccine -- appears to be the template for
Project BioShield. Before legislation removing more liability from drug
companies making vaccines is passed, Senator Burr and other members of the HELP
Committee should include in the bill a bipartisan mandate to Attorney General
Gonzales for an independent criminal investigation of the cover-up of deaths and
illnesses caused by the BioPort anthrax vaccine.
The Biodefense and Pandemic Vaccine and Drug Development Act of
2005 (S. 1873) and a similar bill in the House (H.R. 3970) are being forwarded
during a time when federal health officials are warning that an avian flu
pandemic is imminent.²⁵As you know, currently there is no evidence
that the avian flu virus in question has mutated so that it would be capable of
being transmitted from human to human. Therefore, there is
^{20 "Lawmaker questions Pentagon's plan to
resume anthrax vaccinations", Government Executive, Dec 17, 2004.
http://www.govexec.com/dailyfed/1204/121704c1.htm

^{21 On Oct 27, 2004 the Doe v. Rumsfeld
judge, federal Judge Emmet Sullivan, ruled that FDA had never properly licensed
an anthrax vaccine that the agency had allowed DoD to use for 32 years. See:

http://www.dcd.uscourts.gov/03-707c.pdf
^{22
http://www.fda.gov/cber/vaccine/anthraxeua.htm

^{23 Doe v. Rumsfeld, oral arguments in D.C.
federal district court, Feb 14, 2005.

^{24 "Military Vaccines Trigger Special
Treatment for 1,200", Global Security News, May 6, 2005.
http://www.nti.org/d_newswire/issues/2005_5_6.html#325532E2

^{25 HHS Secretary Mike
Leavitt, CDC Director Dr. Julie Gerberding, et.al., at John R. La Montagne
Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings (2005),
Institute of Medicine (2005), p. 15, et.seq.

http://www.nap.edu/books/0309097312/html/15.html

6
no reason to push through this legislation without any public
debate on policies that will impinge on constitutionally protected civil rights.

While the 2004 Project BioShield Act primarily addressed
bioterror pathogens and countermeasures, S.1873 now also includes blanket
liability protections for those who make and administer vaccines used during
"natural outbreaks" of disease and "pandemics." These provisions will further
erode the freedom and ability of citizens to make fully informed, voluntary
vaccination decisions for themselves or their minor children. Specifically, S.
1873:

• creates a new agency (BARDA) within the Department
of Health and Human Services (DHHS) to oversee the development of
experimental or licensed vaccines and drugs defined as
"countermeasures" which American citizens will be directed to use by
the Secretary of DHHS after the Secretary declares an actual or
potential public health emergency due to deliberate, accidental or
natural outbreaks of illness. This agency will not be subject to the
Federal Advisory Committee Act (FACA) or Freedom of Information Act
(FOIA), meaning there will be no transparency into BARDA
deliberations. Its duties, activities, working groups and advisory
boards also will not be subject to judicial review. [Sec.
3(f)(1)(2)]; and
• prevents American citizens from exercising their
Seventh Amendment right to a trial by jury in the civil court system
if they or their minor children are injured or die from use of
experimental or licensed vaccines and drugs that the Secretary of
Health and Human Services directs citizens to use after declaring
"an actual or potential public health emergency."
[Sec.6(b)(1)(A)(i)].

Additionally, the proposed Bioshield II legislation (S. 1873)
gives the unelected Secretary of Health and Human Services the sole authority to
decide whether a drug company violated laws governing safety and efficacy of
vaccines. The bill bans citizens from challenging the Secretary's decision in
the civil court system. Under Bioshield II, blanket immunity is given to vaccine
makers, as well as to administrators who give citizens experimental vaccines and
drugs without informed consent, whenever the Secretary declares an "actual or
potential emergency" and Governors follow suit.
So, citizens who are injured or die from the effects of
biodefense vaccines and drugs that are developed by federal health agencies and
drug companies in secret will be left to fend for themselves. They will not be
allowed to sue either the pharmaceutical manufacturers or the federal government
for compensation, because S.1873 leaves any federal compensation mechanism
scheme solely to the discretion of the Secretary of Health and Human Services.
As has been demonstrated in the vaccine injury compensation program (VICP) for
children, the DHHS and the Department of Justice have long been reluctant to
either acknowledge the reality of vaccine-induced injury and death -- or to
provide compensation for vaccine victims. Out of the more than 6,018 vaccine
injury claims that have been filed with the VICP since its implementation in
1988 (excluding 4,895 petitions alleging mercury poisoning from thimerosal
containing
7
vaccines), only 1,945 vaccine victims have been awarded
compensation. The public record of what DHHS and Justice -- with the
enthusiastic endorsement of industry -- have done since 1988 to gut the VICP and
turn these vaccine victims away, is tragic.
Although the pharmaceutical industry has repeatedly told
Congress and the American people that civil litigation has driven drug companies
out of the vaccine business, the facts show this claim to be false. In 1982,
there were four drug companies marketing vaccines in the U.S.: Wyeth, Lederle,
Merck and Connaught., Today, after several decades of corporate mergers and
acquisitions, there are twice as many drug companies selling vaccines to
American citizens: Wyeth, Merck, Sanofi Pasteur, GlasxoSmithKline, Medimmune,
Chiron, Bioport and Vaxgen.
There are substantial profits to be made by drug companies
marketing vaccines that are mandated to be used by every child born in America.
The National Childhood Vaccine Injury Act of 1986 has successfully protected the
manufacturers and doctors from almost all lawsuits. There are only ten current
pending vaccine injury lawsuits in U.S. civil courts, most involving the highly
reactive whole cell DPT vaccine no longer distributed in the U.S..²⁶}
The National Vaccine Information Center is informing citizens
about the threat to civil liberties and constitutional freedoms that the
biodefense legislation enacted after September 11, 2001 poses to all Americans.
We believe it is our duty to do this so citizens can exercise their
constitutionally protected rights to contact their elected representatives and
voice their views about provisions in S.1873 that:

• expands the already unprecedented authority given to one
unelected political appointee - the Secretary of Health and Human
Services - to make life-and-death decisions affecting the lives of citizens
without any confirmation by the nation’s elected political leaders: the
President and the Congress.

• denies citizens access to the judicial system to exercise their
Seventh Amendment right to a jury trial of their peers, which serves as the
Constitutional check and balance against abuse of power by the executive
branch of government.

In short, S. 1873 enshrines in federal statute an abdication of
power by elected political leaders so that one unelected individual can deny
Americans’ civil rights and mandate mass experimentation with vaccines and
drugs, while allowing citizens no legal recourse to question what is being done
to them. In essence, this bill and other federal laws passed since 9/11
represent a de facto militarization of US civilian biodefense and disease
control policy.
In any emergency situation, biodefense and disease control
countermeasures jointly developed by government and the pharmaceutical industry
will only be successful
^{26 Marcelo
Ferrari v. American Home Products; Tristan Cravello v. American Home Products;
Bruesewitz v. American Home Products; Totterdale v. Lederle (Wyeth); Militrano
v. Lederle; Romero v. Wyeth; Tenuto v. Lederle; Mann v. Lilly, et al; Gurin v.
Lilly, et al; Wright v. Lilly, et al.

8

if the American people trust the government officials in charge
of implementing the plan. A plan that does not include the principles of
transparency, accountability and justice will fail to win the trust of the
people.
As presently written, BioShield II (S. 1873) fails to adhere to
these principles and is arguably unconstitutional.

Very truly yours,

Barbara Loe Fisher

Co-founder & President

cc: David Dorsey
Attachment (1)
9

National Vaccine Information Center to HELP Cmte – Nov 15, 2005
– Attachment

To begin to address shortcomings in BioShield legislation,
Congress should insure S. 1873 directs:

1) That the authority to declare an emergency under the BioShield Act
should be elevated to the President of the United States and must be
affirmed by the Congress within 30 days.
2) That authority to request a declaration of emergency under the
BioShield Act, or to declare an emergency, may not be delegated by Cabinet
secretaries (as was already done by Secretary of Defense Rumsfeld on Dec 10,
2004).
3) That all actions by executive branch agencies, including DoD, related
to research, development and licensure of BioShield products, the mandate of
their use, and monitoring of their safety with post-licensure surveillance,
will be reviewable by the federal courts and subject to the Freedom of
Information Act and Federal Advisory Committee Act.
4) That federal government civil servants and political appointees will
be subject to investigation and prosecution for licensing decisions and
failures to conduct post-licensure surveillance that violate the Food Drug
and Cosmetic Act, Public Health Service Act, or other applicable federal
statutes. (S. 1873 limits such accountability to "manufacturers,
distributors, administrators, and healthcare providers.")
5) That to the extent pharmaceutical manufacturers of BioShield
countermeasures are indemnified, the federal government must provide
adequate liability coverage for injuries experienced by those who are forced
to take these biodefense products. This coverage must be stipulated in law,
not subject to the discretion of a political appointee, and reviewable by
the federal courts. Citizens who die or are injured after obeying an order
to take these products should have no less coverage than the victims of 9/11
at the World Trade Center and the Pentagon.
6) That if liability for injuries from BioShield countermeaures is
assumed by neither pharmaceutical manufacturers nor the federal government,
then citizens – including military personnel -- must be granted the right to
refuse these products without legal

10

sanctions, including quarantine, or denial of employment, housing,
medical care or schooling, etc.
7) That the definition of covered BioShield countermeasures is not
broadened to include drugs and vaccines, especially childhood vaccines, used
to prevent or treat normal pathogens that are unlikely sources of pandemic
or bioterrorism.
8) That Attorney General Alberto Gonzales appoint an independent special
counsel charged to conduct a criminal investigation of the cover-up by DoD
and HHS employees, as well as the manufacturer, of deaths and serious
illnesses caused by the BioPort anthrax vaccine used by the Department of
Defense since the 1991 Gulf War.

11}}}}}}}}}}}}}}}}}}}}}}}