Arkansas State Health Department: Mandatory Vaccines Are Constitutional

Paul Joseph Watson Prison Planet.com Friday, June 26, 2009

Arkansas State Health Department: Mandatory Vaccines Are Constitutional 260609

A member of the public who was concerned about a mandatory mass vaccination program in light of the swine flu pandemic called the Arkansas State Health Department for advice only to be told that mandatory vaccines were constitutional and could be enforced at gunpoint by the government if necessary. The editor of the popular blog “Pissed Off Former Democrat” phoned the legal council at the Arkansas State Health Department to seek advice about obtaining waiver forms for a future mass swine flu vaccination program. One of his main concerns centered around the fact that the company chosen to mass produce the swine flu vaccine, Baxter International, were recently caught in a scandal after it emerged they had sent out vaccines contaminated with the H5N1 avian flu virus to 18 countries from their Austrian branch. It was only by providence that the contamination was found after the batch was first tested on ferrets in the Czech Republic, before being shipped out for injection into humans. The ferrets all died and the shocking discovery was made. Some Czech newspapers speculated at the time that Baxter was embroiled in a conspiracy to provoke a pandemic from which it would reap billions in profits from producing the vaccine to counter a bird flu outbreak.

As we have previously covered, the last time the government ordered a mass vaccination drive in response to a swine flu outbreak, the program had to be stopped short after the shots caused over 500 cases of Guillain-Barre syndrome, a severe paralyzing nerve disease. 30 people died as a direct result of the vaccinations.

During the phone conversation, the legal council discusses the potential of a future mandatory swine flu vaccination program and states, “That’s constitutional, there’s no doubt about it….mandatory vaccinations are legal under the Supreme Court….absolutely.”   The caller responds, “I’m an American and I have a legal right to make my own decision whether or not someone sticks a needle in me,” to which the legal council responds, “That’s not true….no.” “As a lawyer you believe that I don’t have the right to deny a vaccination,” asks the caller,” to which the legal council responds, “Absolutely….I don’t know why you have a problem with that….mandatory vaccines are constitutional,” adding that it doesn’t matter about personal or religious objections.

The caller then asks how the mandatory vaccine would be enforced by law, “for example somebody sticking a gun in my face,” to which the legal council responds, “you could be held liable.” The legal council at the Arkansas State Health Department cites the 1905 Supreme Court case of Jacobson v Massachusetts to argue that governments can force citizens to take vaccines. Less than 50 years before, in Dred Scott v. Sandford, the Supreme Court also ruled that black people were slaves – property of their slaveowners with no inherent rights whatsoever. 22 years after Jacobson v Mass., in Buck v Bell, the Supreme Court also ruled that people designated “feeble-minded” by the government could be sterilized. The fact that the Supreme Court made a ruling over 100 hundred years ago saying the government could inject people by force doesn’t make it morally or constitutionally justifiable.

To stick needles in people at gunpoint by government decree is blatantly unconstitutional under any reasonable definition of basic human rights or the freedoms enumerated by the founders in the constitution itself. American Indians were rounded up and sent to death camps under legal orders, but that didn’t make it right or justifiable. Hitler’s mistreatment of Jews, Gypsies, political dissidents, homosexuals and others who resisted government policies imposed during times of “emergency” in Nazi Germany was all perpetrated behind a thin veil of legality, but that didn’t make it right either. As a member at the Prison Planet Forum points out, “Tyrannical evil loves to mask itself in the robes of righteousness, to justify itself with legal documents, to trample the very ideas of what Law and Right mean. Resisting that evil, rising against that tyranny, by saying No More. That is right.” As we previously reported, Time Magazine has been preparing Americans to accept the idea of mandatory vaccinations, reporting on April 28th that a mass vaccination program is being readied to combat swine flu while also urging Americans to “trust that the government is working for the greater good” and to not resist draconian measures. Listen to the phone call below.

Phone Conversation

Annual flu vaccine – sales pitch vs common sense

I have been having the annual conversation with a few patients that are thinking of getting the flu shot.

Now, I try really hard not to be judgemental, afterall I really beleive each of us has the right and responsibility to take care of our own bodies.  I do however, try to help people make informed decisions.

Here are few facts as I know them.  (This is off the top of my head so I will not be giving references, thou I can find them if you are interested.)

1.  The flu is  a virus that gets into your body through your nose, or mouth.  Your body knows this and concentrates its immune system defenses in these areas of first contact.

2.  The flu “shot” is injected into your arm.  This is not a normal place of first contact, so your immune system is not very strong here.  In fact, it has been repeatedly published injecting vaccines into the body in this manner drastically increases your risk for Geillon Bar Syndrome and Alzimers Disease.

3.  They guess at three brands of flu viruses to put in each years vaccines.  This guess is based on what viruses were going around Asia last year.  It is very unusual that this guess is anywhere close to accurate.  In fact, the flu virus mutates so fast, by the time the vaccines are ready the virus has already mutated.

4.  Even after congressional direction to remove mercury from vaccines, the flu shot still contains a mercury preservative called thymerisol.  There is a growing body of evidence of a connection between this chemical and autism.

5.  Beyond mercury, the flu shot contains aluminum, formaldehyde, MSG and other toxic chemicals that they want to inject directly into your body!

Any health decision is about risk versus benefit.  If the benefit outweighs the risk, it is a good choice.  But if the risk outweighs the benefit find a less risky option.

Scary Anthrax Rip off

Despite the absence of any anthrax infections among Americans, on October
1, 2008  Mike Leavitt, Secretary of the Department of Health and Human
Service (DHHS) declared a seven-year anthrax emergency through the end of
2015.

Below, AHRP board member, Meryl Nass, MD, questions the legitimacy of that
declared Anthrax “emergency,” noting that over the past month, in the waning
days of the Bush administration, and with no emergency in sight, DHHS is
using the Public Readiness and Emergency Preparedness Act against Americans
(PREPA) to give “blanket immunity from liability to all entities involved
with the manufacturer and distribution of anthrax countermeasures, including
“government program planners.”

The liability provision of PREPA offers broad legal protection for the
makers of drugs, vaccines, and other medical “countermeasures” used–simply
when the DHHS secretary declares an emergency.

Dr. Nass provides documented background behind this last ditch effort to
expand the market for anthrax vaccine–by increasing the US stockpile of the
vaccine–adding $500 million–and by unleashing the controversial vaccine on
civilians–despite continued doubt about the vaccine’s safety.

~~~~~~~~~~~
DHHS DESIGNATES AN ANTHRAX EMERGENCY IN ORDER TO PROTECT–ITSELF!

A series of coordinated moves designed to encourage new uses for anthrax
vaccine (whose safety record is terrible and effectiveness unknown)-while
excluding any manufacturer liability for its use, preempting state and local
laws designed to protect citizens, and extending blanket immunity to
government officials who came up with the plan— is in process.

* First, DHHS Secretary Leavitt declared that the US is in an anthrax
emergency.  This invoked the Public Readiness and Emergency Preparedness
Act, giving blanket immunity from liability to all entities involved with
the manufacturer and distribution of anthrax countermeasures, including
“government program planners”
* Second, Leavitt contracted to buy $400 million worth of anthrax
vaccine, in addition to over $500 million currently in DHHS’ stockpile
* Third, CDC (a DHHS agency) asked its vaccine advisory committee to
vote on changing its previous recommendation for anthrax vaccine on October
22, potentially expanding its use to civilian “first responders”
* Fourth, the vaccine’s manufacturer is constructing a new
manufacturing plant to supply up to 30 million vaccine doses yearly.
* Fifth, CDC conducted a clinical trial of anthrax vaccine in 1564
subjects, but released only partial information on the trial in a JAMA
article published October 1, implying that the vaccine is safe.  Yet 229
severe adverse events and 7 deaths occurred in trial participants, but were
barely mentioned in CDC’s report.

**  Background

The original bill under which Secretary Leavitt made his Declaration, the
Public Readiness and Emergency Preparedness Act (PREPA, part of P.L.
109-148) gave the DHHS Secretary the right to declare any disease an
emergency, triggering immunity from liability for any and all injuries due
to countermeasures for that illness, unless “willful misconduct” by those
who made or administered the product could be proven. The Act fails to
specify any criteria for determining that an emergency exists, and fails to
fund a compensation mechanism.  It was tacked on to the end of the 2006
Defense Appropriations Bill during the night, after being removed from
another bill due to its controversial nature.  It was passed by Congress and
signed into law on December 30, 2005.  Probably few in Congress read it
before approving it along with defense spending.  You can read the bill at:
ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Prepar
edness_Act.pdf

In a news release issued after the bill passed, Senator Frist, R-TN said the
measure “extends limited protections to manufacturers, distributors, and
first responders, so that life-saving countermeasures, such as an H5N1 avian
flu vaccine, will be developed, deployed and administered.”
http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liab
ility.html

But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with
consumer groups such as Public Citizen, derided the liability provision as a
giveaway to the drug industry. Kennedy said the bill makes it “essentially
impossible” for injured parties to sue for damages. He also argued that the
measure allows the HHS secretary to use many common diseases as a reason to
activate the liability shield.  “Without a real compensation program, the
liability protection in the defense bill provides a Christmas present to the
drug industry and bag of coal to everyday Americans,” stated a Dec 21 news
release issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Chris Dodd,
D-Conn.

The Democratic Senators introduced a new bill to supersede PREPA in February
2006, http://www.fas.org/biosecurity/resource/legislation/s2291.htm
but it never passed.

**  Where is the Anthrax Emergency?

Over the past month, in the waning days of the Bush administration, and with
no emergency in sight, DHHS is using PREPA against Americans to shield not
only manufacturers and medical professionals, but also to immunize everyone
in government who worked on the plan from any liability for problems that
arise.
Yes, you heard correctly:  although the media never reported on this
provision when PREPA was passed, the bill specifically shields “government
program planners” who deal with PREPA’s emergencies from all potential
liability.

On October 1, 2008 DHHS Secretary Mike Leavitt declared an anthrax emergency
under the PREPA Act, through the end of 2015.  (That sounds like a very long
emergency-or a very long time to enjoy liability protection.)
http://edocket.access.gpo.gov/2008/E8-23547.htm Despite the current absence
of anthrax infections in Americans, the “emergency” has been declared, and
the liability shield is already in effect for anthrax vaccine and other
anthrax countermeasures, including antiserum, monoclonal antibodies and
multiple antibiotics.

$500 million in new anthrax vaccine spending
October 1, 2008 was a busy day in the anthrax world.  DHHS announced it was
going to purchase an additional 14.5 million doses of anthrax vaccine, for a
cost between $364 and $404 million, to add to its existing stockpile of
about 25 million doses.
http://www.washingtonpost.com/wp-dyn/content/article/2008/10/01/AR2008100102
951.html

The manufacturer, Emergent BioSolutions, crowed about the liability
protection it had just received for the purchase.
http://www.bizjournals.com/baltimore/stories/2008/10/06/daily45.html

Furthermore, on September 26, DHHS announced contracts for a total $113.6
million with Emergent BioSolutions and Pharmathene for development of “Third
Generation” anthrax vaccines.  These too are covered under Secretary
Leavitt’s Declaration.   What vaccines are these?  Emergent bought its
competitor VaxGen’s vaccine for $2 million, after taxpayers and investors
paid over $200 million for its development.  When in 2006 VaxGen failed to
meet DHHS-specified milestones, its contract was cancelled and the company
folded.

Pharmathene bought Avecia’s vaccine, after Avecia received a $100 million
DHHS contract for early vaccine development, but failed to get a more
lucrative contract later.
Bottom line:  both these vaccines were rejected by DHHS during the past five
years, only to suddenly arise again, and consume additional taxpayer
largesse.  Yet if the current vaccine were truly acceptable, a newer vaccine
would be unnecessary.

**  Expanding the anthrax vaccine market

If DHHS simply planned to stockpile more anthrax vaccine, its purchase would
be just another example case of government waste.  The current stockpile is
expiring at a rate of  $10 million per month, as pointed out by GAO last
year.
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/22/AR2007102202
111.html

But DHHS had bigger plans than this.  It eyed a new market for the vaccine,
one that might double or quadruple the amount of vaccine now used by the
military, justifying a new manufacturing plant that manufacturer Emergent Biosolutions is building in
Maryland.  There are up to 3 million “First Responders” in the US: Police,
Firefighters, Emergency Medical Technicians and others.  Maybe they could
profitably use the vaccine, since they might someday face an anthrax
emergency.

On October 22, the CDC ‘s Advisory Committee on Immunization Practices
(ACIP) will vote on whether to overturn its anthrax vaccine recommendations
of 2000 and 2002.
http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf

Back then, ACIP stated that neither the benefit nor the risk for using anthrax vaccine
could not be calculated, and therefore ACIP recommended against its use for
civilians, unless they would be repeatedly exposed to anthrax spores.

2000 Recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm

2002 recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5145a4.htm

**  Risk-Benefit Analysis, the Basis for Public Health Policy-Except In This Case

But, you might argue, first responders and other citizens still cannot
assess the risks and benefits of anthrax vaccination.  Let that be no
deterrent.  As CDC’s Nancy Messonier pointed out to ACIP members in June,

“The intent of the workgroup was to open the door, knowing that the vaccine
is commercially available and that first responder groups are at liberty to
call the manufacturer to obtain the vaccine themselves.  This is really
meant to give them more impetus by saying that even if they do not have a
calculated risk assessment, individuals or groups can assess their own risk,
and weigh the risks and benefits of the vaccine with their occupational
health and safety programs.”
http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf

CDC’s Messonier tossed aside meaningful risk/benefit assessment, the most basic public health requirement, by
suggesting that first responders can (and should) weigh their own risk, even though the
vaccine’s safety and efficacy remain in doubt, and the risk of anthrax is
unknown!  CDC doesn’t want these little omissions to stand in the way of
increasing vaccine use: especially when ACIP members and all federal employees are now shielded from liability for uninformed and ill-considered anthrax vaccine recommendations.

CDC seems to have accurately calculated its own risk/benefit equation.

Meryl Nass, MD
October 14, 2008

fyi, here is an excellent discussion of the 2005 PREPA Bill:
http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liab
ility.html

Pandemic funding, liability shield clear Congress

Dec 28, 2005 (CIDRAP News) – Before adjourning last week, the US Senate
passed and sent to President Bush a bill providing $3.8 billion for pandemic
influenza preparedness and a controversial liability shield for those who
produce and administer drugs and vaccines used in a declared public health
emergency.

The preparedness funding and liability protection were part of the fiscal
year 2006 defense spending bill passed by the Senate on the evening of Dec
21. The bill had cleared the House 2 days earlier.

The $3.8 billion for pandemic preparedness is a little more than half of the
$7.1 billion Bush had requested in early November. House Republican leaders
said last week the measure would fund roughly the fiscal year 2006 portion
of Bush’s request.

As reported previously, the amount includes $350 million to improve state
and local preparedness and directs the Department of Health and Human
Services (HHS) to use most of the rest on “core preparedness activities,”
including increasing vaccine production capacity, developing vaccines, and
stockpiling antiviral drugs.

The liability provision offers broad legal protection for the makers of
drugs, vaccines, and other medical “countermeasures” used when the HHS
secretary declares an emergency. The provision says people claiming injury
from a medical countermeasure can sue only if they prove “willful
misconduct” by those who made or administered it. The bill calls for
Congress to set up a compensation program for injuries, but it provides no
funds for that purpose.

Senate Majority Leader Bill Frist, R-Tenn., and other Republican leaders
argued that the liability measure was necessary to induce biotechnology
companies to develop products to counter pandemic flu and other disease
threats.

In a news release issued after the bill passed, Frist said the measure
“extends limited protections to manufacturers, distributors, and first
responders, so that life-saving countermeasures, such as an H5N1 avian flu
vaccine, will be developed, deployed and administered.”
He added that the bill “strikes a reasonable balance where those who are
harmed will be fairly compensated and life-saving products will be available
in ample supply to protect and treat as many Americans as possible.”

But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with
consumer groups such as Public Citizen, derided the liability provision as a
giveaway to the drug industry. Kennedy said the bill makes it “essentially
impossible” for injured parties to sue for damages. He also argued that the
measure allows the HHS secretary to use many common diseases as a reason to
activate the liability shield.

“Without a real compensation program, the liability protection in the
defense bill provides a Christmas present to the drug industry and bag of
coal to everyday Americans,” stated a Dec 21 news release issued by Kennedy
and Sens. Tom Harkin, D-Iowa, and Chris Dodd, D-Conn.

The liability protection language, called the Public Readiness and Emergency
Preparedness Act, was tacked onto the end of the huge defense-spending bill
(H.R. 2863).

It gives the HHS secretary authority to trigger the liability protection by
declaring an emergency if he or she determines that a disease or other
health threat represents an emergency or may constitute an emergency in the
future. The act does not list any criteria for determining the existence of
an emergency. The declaration would have to list the diseases, populations,
and geographic areas covered and when the emergency would end.

Such an emergency declaration is not subject to court review, and it
preempts any conflicting laws or regulations of states or local communities,
the act says.

The measure says those who make and administer medical countermeasures
covered by an emergency declaration are immune to lawsuits unless the
plaintiff can provide clear evidence of willful misconduct that resulted in
death or serious physical injury. “Willful misconduct” is ruled out if the
party who administered the treatment followed HHS recommendations and
notified health authorities of the relevant injury within 7 days.

In addition, the act instructs the HHS secretary to write regulations “that
further restrict the scope of actions or omissions by a covered person” that
constitute willful misconduct.
A party alleging “willful misconduct” can file suit only in US District
Court in Washington, DC. The plaintiff must have an affidavit supporting the
suit from a physician who did not treat the injured person. Before any suit
can go to trial, a three-judge panel will consider any pretrial motions.
The act says that an HHS emergency declaration will trigger the
establishment of a fund to provide “timely, uniform, and adequate
compensation” to anyone injured by covered medical countermeasures. However,
the measure does not appropriate money for the fund.

A person claiming injury from a covered treatment may not sue without first
trying to collect from the compensation fund. But that requirement applies
only if the compensation program has been funded. A person can sue if HHS
fails to act on the request for compensation within 240 days.
If a plaintiff accepts an award from the compensation fund, he or she is
barred from suing anyone, the act provides.

In arguing that the liability shield is too broad, Kennedy said in his news
release, “The Bush administration could identify Vioxx as a needed
countermeasure to treat the arthritis epidemic or to treat pain associated
with flu, and completely immunize Merck [the manufacturer] from lawsuits
currently pending against it.”

http://edocket.access.gpo.gov/2008/E8-23547.htm

[Federal Register: October 6, 2008 (Volume 73, Number 194)]

[Notices]

[Page 58239-58242]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr06oc08-76]

=======================================================================

———————————————————————–

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Declaration Under the Public Readiness and Emergency Preparedness

Act

October 1, 2008.

AGENCY: Office of the Secretary (OS), Department of Health and Human

Services (HHS).

ACTION: Notice.

———————————————————————–

SUMMARY: Declaration pursuant to section 319F-3 of the Public Health

Service Act (42 U.S.C. 247d-6d) to provide targeted liability

protections for anthrax countermeasures based on a credible risk that

the threat of exposure to Bacillus anthracis and the resulting disease

constitutes a public health emergency.

DATES: This notice and the attached declaration are effective as of the

date of signature of the declaration.

FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, Assistant

Secretary for Preparedness and Response, Office of the Secretary,

Department of Health and Human Services, 200 Independence Avenue, SW.,

Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free

number).

HHS Secretary’s Declaration for Utilization of Public Readiness and

Emergency Preparedness Act for Anthrax Countermeasures

Whereas significant changes in the nature, regularity and degree of

threats to health posed by the use of infectious agents as weapons of

biological warfare have generated increased concern for the safety of

the general American population particularly following the deliberate

exposure of citizens in the

[[Page 58240]]

United States to Bacillus anthracis (B. anthracis) spores in 2001 that

demonstrated the ease of dissemination, infectivity, and mortality;

Whereas the Secretary of Homeland Security has determined that B.

anthracis and multi-drug-resistant B. anthracis present a material

threat against the United States population, sufficient to affect

national security;

Whereas there are covered countermeasures to treat, identify, or

prevent adverse health consequences or death from exposure to B.

anthracis;

Whereas such countermeasures, including vaccines, antimicrobials/

antibiotics, and antitoxins for pre-exposure and post-exposure

prevention and treatment, diagnostics to identify such exposure, and

additional countermeasures for treatment of adverse events arising from

use of these countermeasures exist or may be the subject of research

and/or development;

Whereas such countermeasures may be used and administered in

accordance with Federal contracts, cooperative agreements, grants,

interagency agreements, and memoranda of understanding, and may also be

used and administered at the Regional, State, and local level in

accordance with the public health and medical response of the Authority

Having Jurisdiction;

Whereas, the possibility of governmental program planners obtaining

stockpiles from private sector entities except through voluntary means

such as commercial sale, donation, or deployment would undermine

national preparedness efforts and should be discouraged as provided for

in section 319F-3(b)(2)(E) of the Public Health Service Act (42 U.S.C.

247d-6d(b)) (“the Act”);

Whereas, immunity under section 319F-3(a) of the Act should be

available to governmental program planners for distributions of Covered

Countermeasures obtained voluntarily, such as by (1) Donation; (2)

commercial sale; (3) deployment of Covered Countermeasures from Federal

stockpiles; or (4) deployment of donated, purchased, or otherwise

voluntarily obtained Covered Countermeasures from State, local, or

private stockpiles;

Whereas, the extent of immunity under section 319F-3(a) of the Act

afforded to a governmental program planner that obtains covered

countermeasures except through voluntary means is not intended to

affect the extent of immunity afforded other covered persons with

respect to such covered countermeasures.

Whereas, in accordance with section 319F-3(b)(6) of the Act, I have

considered the desirability of encouraging the design, development,

clinical testing or investigation, manufacturing, labeling,

distribution, formulation, packaging, marketing, promotion, sale,

purchase, donation, dispensing, prescribing, administration, licensing,

and use of such countermeasures with respect to the category of disease

and population described in sections II and IV below, and have found it

desirable to encourage such activities for the covered countermeasures;

and

Whereas, to encourage the design, development, clinical testing or

investigation, manufacturing and product formulation, labeling,

distribution, packaging, marketing, promotion, sale, purchase,

donation, dispensing, prescribing, administration, licensing, and use

of medical countermeasures with respect to the category of disease and

population described in sections II and IV below, it is advisable, in

accordance with section 319F-3(a) and (b) of the Act, to provide

immunity from liability for covered persons, as that term is defined at

section 319F-3(i)(2) of the Act, and to include as such covered persons

such other qualified persons as I have identified in section VI of this

declaration;

Therefore, pursuant to section 319F-3(b) of the Act, I have

determined there is a credible risk that the threat of exposure of B.

anthracis and the resulting disease constitutes a public health

emergency.

I. Covered Countermeasures (As Required by Section 319F-3(b)(1) of the

Act)

Covered Countermeasures are defined at section 319F-3(i) of the

Act. At this time, and in accordance with the provisions contained

herein, I am recommending the manufacture, testing, development,

distribution, dispensing; and, with respect to the category of disease

and population described in sections II and IV below, the

administration and usage of anthrax countermeasures as defined in

section IX below. The immunity specified in section 319F-3(a) of the

Act shall only be in effect with respect to: (1) Present (see Appendix

I) or future Federal contracts, cooperative agreements, grants,

interagency agreements, or memoranda of understanding involving

countermeasures that are used and administered in accordance with this

declaration, and (2) activities authorized in accordance with the

public health and medical response of the Authority Having Jurisdiction

to prescribe, administer, deliver, distribute or dispense the Covered

Countermeasure following a declaration of an emergency, as defined in

section IX below. In accordance with section 319F-3(b)(2)(E) of the

Act, for governmental program planners, the immunity specified in

section 319F-3(a) of the Act shall be in effect to extent they obtain

Covered Countermeasures through voluntary means of distribution, such

as (1) Donation; (2) commercial sale; (3) deployment of Covered

Countermeasures from Federal stockpiles; or (4) deployment of donated,

purchased, or otherwise voluntarily obtained Covered Countermeasures

from State, local, or private stockpiles. For all other covered

persons, including other program planners, the immunity specified in

section 319F-3(a) of the Act shall, in accordance with section 319F-

3(b)(2)(E) of the Act, be in effect pursuant to any means of

distribution.

This declaration shall subsequently refer to the countermeasures

identified above as “Covered Countermeasures.”

This declaration shall apply to all Covered Countermeasures

administered or used during the effective time period of the

declaration. This declaration also shall apply to all Covered

Countermeasures (see Appendix I) administered or used by or on behalf

of the Department of Defense.

II. Category of Disease (As Required by Section 319F-3(b)(2)(A) of the

Act)

The category of disease, health condition, or threat to health for

which I am recommending the administration or use of the Covered

Countermeasures is anthrax, which may result from exposure to B.

anthracis.

III. Effective Time Period (As Required by Section 319F-3(b)(2)(B) of

the Act)

With respect to Covered Countermeasures administered and used in

accordance with present or future Federal contracts, cooperative

agreements, grants, interagency agreements, or memoranda of

understanding, the effective period of time of this Declaration

commences on signature of the declaration and extends through December

31, 2015.

With respect to Covered Countermeasures administered and used in

accordance with the public health and medical response of the Authority

Having Jurisdiction, the effective period of time of this Declaration

commences on the date of a declaration of an emergency and lasts

through and includes the final day that the emergency declaration is in

effect including any extensions thereof.

[[Page 58241]]

IV. Population (As Required by Section 319F-3(b)(2)(C) of the Act)

Section 319F-3(a)(4)(A) of the Act confers immunity to

manufacturers and distributors of the Covered Countermeasure,

regardless of the defined population.

Section 319F-3(a)(3)(C)(i) of the Act confers immunity to covered

persons who may be a program planner or qualified persons with respect

to the Covered Countermeasure only if a member of the population

specified in the declaration as persons who use the Covered

Countermeasure or to whom such a Covered Countermeasure is

administered, is in or connected to the geographic location specified

in this declaration, or the program planner or qualified person

reasonably could have believed that these conditions are met.

The populations specified in this declaration are all persons who

use a Covered Countermeasure or to whom a Covered Countermeasure is

administered in accordance with this declaration, including, but not

limited to: Department of Defense military personnel and supporting

civilian-employee and contractor personnel; any person conducting

research and development of Covered Countermeasures directly by the

Federal government or pursuant to a contract, grant, or cooperative

agreement with the Federal government; any person who receives a

Covered Countermeasure from persons authorized in accordance with the

public health and medical emergency response of the Authority Having

Jurisdiction to prescribe, administer, deliver, distribute, or dispense

the Covered Countermeasure, and their officials, agents, employees,

contractors, and volunteers following a declaration of an emergency;

any person who receives a Covered Countermeasure from a person

authorized to prescribe, administer or dispense the countermeasure or

who is otherwise authorized under an Emergency Use Authorization; any

person who receives a Covered Countermeasure as an investigational new

drug in human clinical trials being conducted directly by the Federal

government or pursuant to a contract, grant, or cooperative agreement

with the Federal government.

V. Geographic Area (As Required by Section 319F-3(b)(2)(D) of the Act)

Section 319F-3(a) of the Act applies to the administration and use

of a Covered Countermeasure without geographic limitation.

VI. Qualified Persons (As Required by Section 319F-3(i)(8)(B) of the

Act)

With regard to the administration or use of a Covered

Countermeasure, Section 319F-3(i)(8)(A) of the Act defines the term

“qualified person” as a licensed individual who is authorized to

prescribe, administer, or dispense the Covered Countermeasure under the

law of the State in which such Covered Countermeasure was prescribed,

administered or dispensed. Additional persons who are qualified persons

pursuant to section 319F-3(i)(8)(B) are the following: (1) Any person

who is authorized to prescribe, administer, deliver, distribute or

dispense Covered Countermeasures to Department of Defense military

personnel and supporting civilian-employee and contractor personnel,

(2) Any person authorized in accordance with the public health and

medical emergency response of the Authority Having Jurisdiction to

prescribe, administer, deliver, distribute or dispense Covered

Countermeasures, and their officials, agents, employees, contractors

and volunteers, following a declaration of an emergency, and (3) Any

person authorized to prescribe, administer, or dispense Covered

Countermeasures or who is otherwise authorized under an Emergency Use

Authorization, including, but not limited to Department of Defense

military personnel and supporting civilian employee and contractor

personnel.

VII. Additional Time Periods of Coverage After Expiration of

Declaration (As Required by Section 319F-3(b)(3)(B) of the Act)

I have determined that, upon expiration of the time period

specified in Section III above, an additional twelve (12) months is a

reasonable period to allow for manufacturers and other covered persons

to take such other actions as are appropriate to limit the

administration or use of the Covered Countermeasure, and the liability

protection of section 319F-3(a) of the Act shall extend for that

period. Further, as to doses shipped by the CDC to the DoD pursuant to

the DoD/CDC Interagency Agreement (IAA) dated March 10, 2008, an

additional period of time of liability protection shall extend for as

long as the SNS or its successor exists and the IAA remains in effect,

plus, if the additional twelve (12) months following the time period in

Section III above has expired, an additional twelve (12) months upon

expiration of the IAA.

VIII. Amendments

This declaration has not previously been amended. Any future

amendment to this declaration will be published in the Federal

Register, pursuant to section 319F-3(b)(4) of the Act.

IX. Definitions

For the purpose of this declaration, including any claim for loss

brought in accordance with section 319F-3 of the PHS Act against any

covered persons defined in the Act or this declaration, the following

definitions will be used:

Administration of a Covered Countermeasure: As used in Section

319F-3(a)(2)(B) of the Act includes, but is not limited to, public and

private delivery, distribution, and dispensing activities relating to

physical administration of the Covered Countermeasures to patients/

recipients, management and operation of delivery systems, and

management and operation of distribution and dispensing locations.

Anthrax Countermeasure: Any vaccine; antimicrobial/antibiotic,

other drug or antitoxin; or diagnostic or device to identify, prevent

or treat anthrax or adverse events from such countermeasures (1)

Licensed under section 351 of the Public Health Service Act; (2)

approved under section 505 or section 515 of the Federal Food, Drug,

and Cosmetic Act (FDCA); (3) cleared under section 510(k) of the FDCA;

(4) authorized for emergency use under section 564 of the FDCA ; (5)

used under section 505(i) of the FDCA or section 351(a)(3) of the PHS

Act, and 21 CFR Part 312; or (6) used under section 520(g) of the FDCA

and 21 CFR part 812.

Authority Having Jurisdiction: The public agency or its delegate

that has legal responsibility and authority for responding to an

incident, based on political or geographical (e.g., city, county,

tribal, State, or Federal boundary lines) or functional (e.g., law

enforcement, public health) range or sphere of authority.

Covered persons: As defined at section 319F-3(i)(2) of the Act

include the United States, manufacturers, distributors, program

planners, and qualified persons. The terms “manufacturer,”

“distributor,” “program planner,” and “qualified person” are

further defined at sections 319F-3(i)(3), (4), (6), and (8) of the Act.

Declaration of an emergency: A declaration by any authorized local,

regional, State, or federal official of an emergency specific to events

that indicate an immediate need to administer and use anthrax

countermeasures, with the exception of

[[Page 58242]]

a federal declaration in support of an emergency use authorization

under section 564 of the FDCA unless such declaration specifies

otherwise.

This first day of October, 2008.

Michael O. Leavitt,

Secretary of Health and Human Services.

Appendix I–List of U.S. Government Contracts

—————————————————————————————————————-

Contract                      Manufacturer          Covered countermeasure    PL 85-804  coverage*

—————————————————————————————————————-

HHSO100200500007C……………….  Cangene…………….  Anthrax immune globulin–    No.

AIG.

HHSO100200500006C……………….  HGS………………..  Anthrax monoclonal antibody- No.

ABThrax.

HHSO100200600019C……………….  Emergent Biodefense      BioThrax (Anthrax Vaccine    Yes.

Operations.              Adsorbed, AVA).

HHSO100200700037C……………….  Emergent Biodefense      BioThrax (Anthrax Vaccine    No.

Operations.              Adsorbed, AVA).

W9113M-04-D-0002………………..  BioPort (Emergent        BioThrax (Anthrax Vaccine    Yes.

Biosolutions).           Adsorbed, AVA).

DAMD 17-97-D-00003………………  BioPort (Emergent        BioThrax (Anthrax Vaccine    Yes.

Biosolutions).           Adsorbed, AVA) Shipping.

HHSN 272200700035C………………  Elusys……………..  Anthrax monoclonal           No.

antibody–ETI-204.

HHSN 272200700033C………………  Pharmathene…………  Anthrax monoclonal           No.

antibody–Valortim.

HHSN 272200700034C………………  Emergent BioSolutions..  Anthrax immune globulin–    No.

AIG.

NO1-A1-30052……………………  Avecia (Pharmathene)…  Recombinant protective       No.

antigen (rPA) anthrax

vaccine.

V797P-5777x…………………….  Shering Corp………..  Cipro 250mg/5ml; 100ml       No.

suspension.

V797P-5977x…………………….  Cobalt Pharmaceuticals.  Cipro 500mg tablets……..  No.

V797P-5941x…………………….  Blu Pharmaceuticals….  Doxycycline 100mg tablets..  No.

V797P-5883x…………………….  Pfizer, Inc…………  Doxycycline 25mg/5ml         No.

suspension 60ml.

V797P-5669x…………………….  Abraxis Bioscience, Inc  Doxycycline 100mg vial IV..  No.

V797-DSNS-8002………………….  Sandoz, Inc…………  Amoxicillin 500mg capsules.  No.

V797-DSNS-8002………………….  Sandoz, Inc…………  Amoxicillin 400mg/5ml;       No.

100ml suspension.

V797BPA0015…………………….  Bedford Labs………..  Rifampin 600mg vial IV…..  No.

V797P-5396x…………………….  Hospira…………….  Clindamycin 150mg/ml 6ml     No.

vial IV.

V797P-5669x…………………….  Abraxis Bioscience, Inc  Vancomycin 1 g vial IV…..  No.

V797P-1020x…………………….  McKesson……………  Penicillin GK 20 million     No.

unit vial IV.

V797P-5387x…………………….  Johnson and Johnson      Levofloxacin 5mg/ml 150ml    No.

Healthcare.              bag IV.

—————————————————————————————————————-

* Status of indemnification coverage under P.L. 85-804 (An Act to authorize the making, amendment and

modification of contracts to facilitate the national defense.)

[FR Doc. E8-23547 Filed 10-1-08; 4:15 pm]

BILLING CODE 4150-37-P

PROVE provides information on vaccines, and immunization policies and practices that affect the children and adults of Texas. Our mission is to prevent vaccine injury and death and to promote and protect the right of every person to make informed independent vaccination decisions for themselves and their family.

This information is not to be construed as medical OR legal advice.

Contact Information
http://vaccineinfo.net/contactus.html (web site)

Financial connections between vaccine makers and foundations

by Barbara Loe Fisher

w ww.vaccineawakening.blogspot.com
www.NVIC.org
www.Stand UpBeCounted.org


When it comes to hiding vaccine risks from the people, all you have to do is “follow the money” to find out who has always done it the best. There are a number of influential non-profit organizations such as the American Academy of Pediatrics (AAP), Every Child by Two, and Immunization Action Coalition (IAC) that have been funded by drug companies selling vaccines and/or have been paid by federal agencies using taxpayer dollars to push vaccine use.

On July 25, CBS News reported on some of the financial ties between vaccine manufacturers and non-profit organizations or individuals (i.e., rotavirus vaccine patent holder Paul Offit, M.D.) who are aggressively promoting vaccination and refusing to acknowledge vaccine risks. The report infuriated a new “non-profit” organization, Voices for Vaccines, that demanded CBS News retract its story and “apologize” for informing the public about the money connection between the pharmaceutical industry and individuals and organizations urging people to buy and use vaccines. On August 1, CBS News issued a statement defending the public’s right to know:

“Our report last Friday represents one part of the extensive reporting CBS News has done, and will continue to do, on the issues surrounding vaccines and possible links to autism. That continuing coverage has repeatedly reported on the critical importance of the nation’s maintaining a robust vaccination program for children. Reporting on what critics, including members of Congress, believe to be potential conflicts of interest for vaccine advocates who receive funding from vaccine makers is also an entirely legitimate aspect of our overall coverage. We believe our report was in no way defamatory of any institution or individual, and that no retraction is warranted.”

While parents are doing their own research so they can make educated vaccine choices for their children that minimize vaccine risks, celebrities questioning vaccine safety such as Jenny McCarthy are being challenged by celebrities defending vaccine safety such as Amanda Peet, Yesterday, Peet became the celebrity spokesperson for Every Child by Two.

When you connect the dots in a “Follow the Vaccine Money” exercise, you don’t have to look very far to see who is paying who to promote unquestioning faith in the safety of vaccines and one- size-fits-all vaccine policies. It takes a lot of money for the drug companies and their allies to persuade parents that it is necessary to pump 69 doses of 16 vaccines into children from birth to age 18 to keep them healthy.

Here are some of the major players:

* The Carter Center, founded in 1984 by Jimmy and Rosalyn Carter is affiliated with Emory University and sponsors vaccination programs funded by drug companies and operated by former employees of the CDC. (Rosalyn Carter co- founded Every Child by Two with Betty Bumpers in 1991 with funding from vaccine manufacturers.) Several vaccine manufacturers have donated more than $1 million to the Carter Center.

* The International Task Force for Disease Eradication is sponsored by the Carter Center and operates programs that are funded by vaccine manufacturers (see “Health Program Partners”at ) and directed by present and former CDC officials for the purpose of eradicating infectious diseases including polio, mumps and rubella through mass vaccination programs.

* The Carter Center is a partner with the Task Force for Child Survival and Development, which sponsors programs funded by vaccine manufacturers and directed by former CDC officials such as William Foege, M.D., M.P.H. and Alan Hinman, M.D., M.P.H.

* The Task Force for Child Survival and Development is sponsoring Voices for Vaccines, which has a Steering Committee composed of individuals employed by an affiliate of the Carter Center or Every Child by Two and non-profit organizations, many of whom receive funding from vaccine manufacturers such as the American Academy of Family Physicians and Immunization Action Coalition and P-Kids and Families Fighting Flu.

These are only some of the major players keeping the Vaccine Machine up and running smoothly in the U.S. It is a machine powered by a national and international web of individuals working for and with major pharmaceutical corporations, government health agencies, non-profit medical organizations, world banks, the World Health Organization and wealthy philanthropic foundations such as the Bill and Melinda Gates Foundation to make sure that people in every country continue to purchase and use many vaccines without thinking about it.

The public health program that began with a mandate to eradicate smallpox from the earth using smallpox vaccine has turned into a lucrative ATM for the drug companies. It provides a kind of money laundering scheme for “non-profits” who pretend to be free from conflicts of interest with an industry whose products they are hawking. It has also become a money pit for the American taxpayer feeding the insatiable Vaccine Machine creating hundreds of new vaccines being tested in more than 2,000 clinical trials that will no doubt be candidates for future vaccine mandates.

Amanda Peet, who is being coached by doctors to tell parents to “trust the doctors,” has learned her lines well but neither she nor Jenny McCarthy will ultimately decide the fate of the vaccine safety and informed consent movement begun by parents of vaccine injured children in 1982. Because what is at stake is not the outcome of a Hollywood celebrity face- off but the ability of the American people to free themselves from the tyranny of the “medical experts” who have betrayed the public trust by failing to do their job.

For nearly three decades, before and after passage of the National Childhood Vaccine Injury Act of 1986, parents have been calling on doctors in charge of the mass vaccination system to find out how and why vaccines injure and kill some children. We have been asking doctors to give us a good explanation for why so many of our highly vaccinated children are so chronically ill with 1 in 6 becoming learning disabled; 1 in 9 suffering with asthma and 1 in 150 developing autism. And the only explanation we get or action we have seen is doctors and government health agencies sticking their heads in the sand and twisting themselves into pretzels yelling “it’s a coincidence” every time a child regresses into chronic poor health after vaccination.

The last thing we need to do is return to the dark ages when we allowed ourselves to be treated like the infants whose lives we entrusted without question to paternalistic pediatricians patting us on the head. You don’t have to have an M.D. or Ph.D. written after your name to become an informed health care consumer and weigh the benefits and risks of vaccination in order to make an intelligent, well considered vaccine decision for your child or yourself.

Unquestioning faith belongs in a church and not in a doctor’s office.

Some want personal vaccine exemption restored in Missouri

Some want personal vaccine exemption restored in Missouri

Saturday, March 1, 2008

KANSAS CITY, Mo. — Darrel Drumright has worked in the health care field for 15 years, but he doesn’t trust immunizations.So for years, the Kansas City chiropractor and father of three has chosen not to vaccinate his children. His reason — on paper anyway — is religion. His family is Catholic, so they claim a religious exemption, which allows the kids to skip their shots.

But what Drumright really wants is to tell the truth: He and his wife are skeptical about vaccines and feel the shots required for such childhood diseases as measles and chicken pox could cause more harm than good.

At a time when more parents are using religious exemptions to opt out of getting their children vaccinated, he and others want Missouri to go back to allowing parents who don’t want to immunize their school-age children to do so without having to give a reason.

Drumright, 45, said he and others are pushing for a personal exemption — also known as a philosophical or conscientious exemption — this legislative session. They have been talking to legislators about the issue, hoping to spark support.

“The point of it is the parents should be in charge of the health care needs of their children,” said Drumright, whose daughter is 8 and sons are 6 and 4. “It’s not up to the state to dictate to parents how they should make important health-care decisions about their children.”

Sen. John Loudon, R-Chesterfield, said he’s considering backing a proposal for a personal exemption. He has headed similar efforts in the past, most recently in 2003.

“I am always open to it,” Loudon said of the idea of a personal exemption. “I think when a parent does their diligence and has cause for alarm, they should have the authority over government to control the health of their children.”

Earlier this month, Loudon refiled a bill that he said should help determine the level of support among legislators for a personal exemption.

Loudon’s bill deals with the issue of vaccine control, but as it relates to lawmakers, not parents. It seeks to give the legislature full control over mandating new vaccines. Under the proposal, state health officials still would control how vaccines that are already required are administered to children, but they could not add new mandatory vaccines without legislative approval.

Although the deadline for filing legislation in the Senate has passed, Loudon said he still would work with fellow legislators to get a personal exemption bill filed in the House if his vaccine control proposal is well-received. The chances of such a bill moving through the Legislature, however, decrease the longer they wait to get started.

Missouri parents once had the right to exempt their children from immunizations without needing to provide a reason. But the law changed in 1992, and now parents can only opt out of their kids’ shots for religious or medical reasons.

Drumright and other opponents of vaccines say medical exemptions can be difficult to get a doctor to sign off on, and religious exemptions put parents in an awkward position. They say parents might feel wrong about giving religion — though parents in Missouri can cite religion without having to declare a particular faith — as a reason if their resistance to vaccines has nothing to do with their faith.

The Associated Press has found that a small but growing number of parents around the country are claiming religious exemptions to avoid vaccinating their children when the real reason may be skepticism of the shots or concern they can cause other illnesses.

“While you can never guarantee that immunizations will not cause a problem, they are extremely safe. But the diseases are not,” said Sue Denny, a spokeswoman with the Missouri Department of Health and Senior Services. “It’s in the best interest of maintaining the health of not only school children but the rest of the population to have a high immunization rate.”

Denny said the health department has only seen a slight increase in the number of parents using the religious exemption in recent school years, while the number using the medical exemption has stayed about the same.

State health department records show that about 4,700 religious exemptions and more than 1,500 medical exemptions were claimed for Missouri students during the 2006-2007 school year, the most recent year in which data is available.

In the 15 years since Missouri’s vaccine exemption law changed, there have been moves to restore it but none were successful. Vaccine critics, both locally and nationally, think an exemption proposal could have a chance now.

According to the Centers for Disease Control and Prevention and an AP survey of state health departments, 20 states allow parents to cite personal or philosophical reasons for opting out of their children’s immunizations. The most recent to add a personal exemption was Texas in 2003.

“As more and more vaccines are being added to the list, that is where you’re getting some pushback by parents, and legitimately so,” said Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, a vaccine safety watchdog agency in Vienna, Va.

She said parents are feeling pressured and powerless with all the vaccine mandates.

“The one-size-fits all approach to vaccinations … is simply not medically responsible,” Fisher said. “Parents have to be given more flexibility.”

Koreen Bowers, a mother of three from St. Louis, said she’s wrestling with whether she will claim a religious exemption to avoid certain vaccines for her oldest child, who starts kindergarten next school year. She wishes Missouri had a philosophical exemption like her home state, Minnesota.

“I think it just puts a little more control in the hands of concerned parents,” said Bowers, 39, a financial services worker. “It’s not just about being anti-vaccine. It’s about allowing parents to be a little more selective and be able to make an informed decision.”

Drumright said parents often are not aware they have options. They go with the notion that vaccines are mandatory and don’t think to question it, he said.

“We need an exemption where the parent can say ‘I’m an informed consumer’ and ‘No thank you,’ ” Drumright said.