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Statement of Rep. Dave Weldon, M.D. (Fl-15)

July 26, 2006

 

Federal agencies charged with overseeing vaccine safety research have

failed. They have failed to provide sufficient resources for vaccine

safety research. They have failed to fund extramural research. And,

they have failed to free themselves from conflicts of interest that

serve to undermine public confidence in the safety of vaccines.

 

The American public deserves better and increasingly parents and the

public at large are demanding better.

 

I'm a physician. I understand the importance of immunizations in

protection children and the public at large from infectious disease.

As a society we benefit from vaccines and as such it is important that

we guard carefully vaccine safety research to ensure its objectivity.

 

When I first began working on this issue about seven years ago, I was

shocked at the dearth of resources dedicated to vaccine safety

research. The federal government dedicates far more resources to

promoting the immunizations than in safety evaluations. Most vaccine

safety resources are dedicated to considering short-term, or acute

adverse reactions, while very few resources are dedicated to

considering potential longer-term or chronic adverse reactions.

 

When I first tasked my staff with investigating this issue we got a

lot of confused responses from federal agencies. The FDA told us to

check in with the CDC, saying CDC did most of the vaccine safety

research. The CDC referred us over to the NIH. Then, the NIH

referred us back to the CDC. It was apparent to me that there is

little coordination and very few resources dedicated to vaccine safety

research.

 

Ironically, 20 years ago Congress established The National Vaccine

Program Office (NVPO) and charged NVPO with coordinating vaccine

safety research. Along with safety, however, NVPO was charged with

coordinating vaccine development, vaccine promotion and vaccine supply

- the very conflicts that plague the CDC, and to some extent the NIH.

It is no wonder that vaccine safety has been on the back burner at

NVPO for all of these years - NVPO has conflicting missions and higher

priorities. NVPO is now swamped with Avian Flu preparedness and is

not an appropriate place for this.

 

I agree with the prestigious journal Nature when in January of this

year stated: "there is a strong case for a well-resourced independent

agency that commends the trust of both the government and the public."

That is why we are here today.

 

Several issues relating to vaccine safety have persisted for years.

The response from public health agencies has been largely defensive

from the outset and the studies plagued by conflicts of interest.

Legitimate questions persist regarding the possible association

between the mercury-based preservative, thimerosal, and the childhood

epidemic of neurodevelopmental disorders (NDDs), including autism.

There are unresolved questions about the MMR vaccine that arose in

1998 that should be fully investigated. Gardasil, the HPV vaccine was

just recommended by the CDC. Vaccine manufactures have dozens of new

vaccines in the pipeline. The failure of public health officials to

make this a priority and to free this research from conflicts of

interest will only serve to further erode public confidence at a time

when we should be working to build public confidence. It is

incumbent upon us to fully investigate these issues in an independent

manner.

 

The Senate is turning its attention to FDA reform. Unfortunately, the

legislation moving through the Senate HELP Committee is deafeningly

silent when it comes to improving vaccine safety research. This is

particularly ironic given that federal and state governments do not

mandate drugs in order to enter schools or obtain employment, yet, as

a society we do impose such mandates with regard to vaccination. This

is all the more reason to be particularly mindful of issues related to

vaccine safety.

 

In his book on the subject of immunizations, Dr. Graham Wilson, the

former Director of the Public Health and Laboratory Service for

England and Wales, warned the public health community of the need to

remain ever vigilant when it comes to vaccine safety. In 1967 he warned:

 

"Over confidence must at all costs be avoided… It is for us, and for

those who come after us, to see that the sword which vaccines and

antisera have put into our hands is never allowed to tarnish through

over-confidence, negligence, carelessness, or want of foresight on our

part."

 

Federal agencies in the U.S. charged with carrying out vaccine safety

have failed to adequately heed this warning. If we continue down the

current path, confidence in vaccines will continue to erode and this

"sword" against disease will be tarnished.

 

Today, we rarely come face to face with vaccine preventable disease,

but we are at risk of seeing vaccine preventable diseases rear their

ugly head. Why? Because, we are confronted with the side effects of

vaccines, adverse reactions and perceived adverse reactions - many of

them mild, but some of them severe. This is the new and increasing

challenge that we face in fighting disease.

 

There are two approaches we can take in the face of this new challenge.

 

First we can downplay the existence of adverse reactions or otherwise

pretend they do not exist all-the-while such questions persists

unanswered and continue to fester. Such approaches have failed to

work in the past and over the long-run they can do irreparable harm to

public confidence in vaccines, breaking the trust with the public and

leading to the rise of infectious disease.

 

Conversely, we can take such hypotheses and evaluate them in an

independent and objective manner. That is what we are proposing here

today. Our bill corrects past mistakes. Presently, vaccine safety

research is an in-house function conducted predominantly by the CDC -

the very agency that makes vaccine recommendations and promotes their

uptake. This should not be.

 

We have seen fit to eliminate such conflicts across federal agencies.

 

o At the National Institutes of Health we recognized the inherent

conflicts of interest and created the Office of Human Subjects

Protection as a separate office within HHS.

 

o When we established the Superfund program, Congress established

the Agency for Toxic Substances and Disease Registry (ATSDR) -

Superfund's science evaluation office - as a separate agency in

another department. Safety evaluation is independent of all other

decisions.

 

o After the Space Shuttle Columbia accident, the Gehman Commission

recommended that decisions about shuttle safety and launching the

shuttle should be completely separate - we adopted this recommendation.

 

What does our bill do? It:

o Creates a new agency of vaccine safety that reports directly to

the Secretary of HHS.

o Vaccine safety research is conducted in a manner that is

completely independent of any and all other vaccine-related decisions.

o Establishes a scientific review panel, similar to NIH's study

sections, to evaluate the scientific merits of investigator-initiated

research as the Institute of Medicine has recommended.

o Establishes a balanced 18 Member Advisory Committee to formulate

a safety research agenda and to prioritize research approve by the

scientific study group. Committee Includes:

o 2 vaccine industry reps

o A pediatrician

o An immunologist

o A toxicologist

o An infectious disease expert

o A geneticist

o Not less than 1/3rd of the members of the Committee have a

vaccine-related injury or injured child.

 

Finally, as you may know the CDC has acknowledged this internal

conflict. Last year, Dr. Gerberding moved the CDC's Immunization

Safety Office out from under the National Immunization Program (NIP),

however vaccines safety remains within the CDC. While I appreciate

this initiative, and I understand her limitations in not being able to

move vaccine safety outside of her agency, vaccine safety research

remains woefully short of the degree of independence and funding

commitment that is needed to garner wide public support and acceptance.

 

If government-funded vaccine safety research is to be broadly

accepted, we must eliminate all real and perceived conflicts of

interest. Otherwise, we will fail to achieve the level of acceptance

that is necessary to restore, build, and secure public confidence over

the long-run. A vaccine safety program housed anywhere within the CDC

fails to achieve this independence.

 

We will create a separate and wholly independent office for vaccine

safety research. The question that we face at present is:

 

'Will we create this office now in a proactive manner before public

confidence further erodes, or will we do it later in reaction to

growing loss of public confidence in the hope of restoring lost trust.

 

I suggest we act now and that is what Rep. Maloney and I plan to do.

It is the wiser course.

 

----------------------------------------------------------

VACCINE BILL SECTION BY SECTION

 

Section 1. Short Title; Table of Contents

This act may be cited as the "Vaccine Safety and Public Confidence

Assurance Act of 2006.'

 

Section 2 Findings

 

Section 3 Purpose

To direct that vaccine safety monitoring and research focus on active

surveillance, researching biological mechanisms for acute and chronic

adverse events following vaccination, developing prevaccination

screening methods within a framework that is free from actual and

perceived biases, and developing a vaccine safety research agenda.

 

Section 4. Establishment of Agency for Vaccine Safety Evaluation

(inserted as Subtitle 3 of Title XXI of the Public Health Service Act)

Sec. 2141 Establishment

The Agency for Vaccine Safety Evaluation (AVSE) is established within

HHS, to be directed by the Director for Vaccine Safety Evaluation.

 

Sec. 2142 Authorities

a) With respect to vaccines, the Director shall:

(1) Conduct or support safety research, including research on:

a. Acute and chronic adverse reactions

b. Vaccine components

c. Delivery mechanisms

d. Potential presence of adventitious agents in vaccines

(2) Conduct or support long- and short-term monitoring

(3) Develop a vaccine safety research agenda

(4) Conduct or support research across a range of disciplines

(5) Conduct or support research to address claims of injury

(6) Develop, evaluate, and test hypotheses about potential adverse

reactions

(7) Evaluate and promote compliance of healthcare providers and

vaccine manufactures with Federal requirements related to adverse

event reporting

(8) Conduct or support research for the purpose of developing

tools to prescreen individuals at risk for a vaccine-related adverse

reactions

(9) Conduct or support research into the biological mechanisms of

potential adverse reactions

(10) Conduct long-term monitoring of new or altered vaccines,

including monitoring changes to the childhood and adolescent

immunization schedule of CDC

(11) Provide a public database of pre and post licensure vaccine

studies.

 

:) Personnel conflict-of-interest issues:

1) Senior management positions (GS15 and higher) may not be filled

by individuals who have been previously employed by CDC, FDA vaccine

manufacturers to carry out any function related to vaccine safety or

monitoring or vaccine development or by NIH in vaccine development for

a period of 5 years.

2) All personnel must be free of professional, familial, or

financial conflicts of interest.

 

c) Grant recipients are also subject to conflict-of-interest

requirements, including financial conflicts that may compromise the

perceived integrity of the research.

 

d) Vaccine Safety Datalink Project

(1) Responsibility for overseeing the VSD is transferred to the AVSE.

(2) CDC and FDA have access to the VSD as needed to support their

efforts.

(3) External access to the VSD is facilitated by the AVSE in a

manner similar to that recommended by the IOM in their 2005 report.

e) The Director is also directed to review international

activities of the Federal Government related to vaccine safety and

develop plans for reducing any conflicts of interest uncovered during

the review. A report of the review must be submitted to Congress.

f) The Director may also establish a fellowship program for

training individuals in vaccine safety research. Fellowship

recipients are also subject to certain conflict of interest provisions.

g) Grants will be awarded using the peer review system, subject to

the provisions of the NIH peer review system.

h) The FDA shall provide the agency complete access to vaccine

safety information, but the agency must keep this information

confidential, subject to the same confidentiality provisions as FDA.

i) The Director shall submit a report on the Agency's activities

to: ACIP, NVAC, NVPO, NVICP, HRSA, and any other entity deemed

appropriate. These reports shall be made publicly available.

 

Sec. 2143 Post-marketing vaccine safety

a) The Director shall, in consultation with the FDA, require

manufacturers to provide for post-marketing surveillance and clinical

testing for any acute or chronic reactions associated with all

vaccines approved after January 1, 2006. These trials shall be

conducted by researchers, free from conflicts of interest, recommended

by the Advisory Council and approved by the Director. The protocols

must be similarly approved, and the data must be made available for

objective, independent evaluation.

:P FDA and CDC maintain the ability to monitor vaccine safety

through VAERS.

c) The Director may also award grants to conduct comparative

studies of vaccines licensed for preventing or mitigating the same

disease, and the results of these studies shall be made publicly

available.

d) Clinical Trials (pre- and post-licensure) must be

registered-prior to their completion-subject to requirements similar

to those imposed by the International Committee of Medical Journal

Editors.

 

Sec. 2144 Transfer of CDC Functions related to monitoring adverse

reactions related to licensed vaccines.

a) The following are transferred from CDC to the AVSE:

(1) The Vaccine Safety Datalink Project

(2) The Clinical Immunization Safety Assessment Centers

(3) Other vaccine safety assets of CDC

:P This transfer will be overseen by the Secretary of HHS, in an

orderly fashion.

c) Nothing in this bill, except with respect to the functions

listed in (a) shall be construed so as to prohibit CDC from conducting

vaccine surveillance and response, particularly with respect to acute

reactions.

 

Sec. 2145 Advisory Council (p. 23)

a) The Secretary is directed to establish an Advisory Council

:( The Advisory Council's duties include: formulating

recommendations for research on vaccines, developing a vaccine safety

research agenda, reviewing grant applications and making

recommendations to the Secretary regarding funding of those applications.

c) The Secretary is required to consider the recommendations of

the Advisory Council when making final funding decisions. If the

Secretary decides not to accept the recommendations of the council,

he/she must explain in writing to the Advisory Council the reasons for

these decisions. This letter should be made publicly available.

d) The Advisory Council shall be composed of 18 members, including:

a. Not more than two representatives of the vaccine manufacturing

industry

b. One practicing pediatrician

c. One infectious disease expert

d. Five adults who are each either a victim of a vaccine injury or

a parent of the victim of a vaccine-related injury.

e. One representative of the general public who is free from bias

f. One toxicologist

g. One neurologist

h. One geneticist

i. One immunologist

j. One state or local public health official

k. Not less than 4 and not more than 6 additional representatives

At least one-third of the council must be selected from among

individuals who are vaccine-injured or who have a child who has been

vaccine injured (regardless of whether or not there has been a

judicial or administrative finding of injury).

 

The Advisory Council is also subject to certain conflict of interest

provisions with following exceptions: 2 of the vaccine-injured parents

may have claims pending in the Vaccine Injury Compensation Program,

and the 2 industry representatives are not subject to the conflict of

interest provisions.

 

Sec. 2146 Full-time liaisons The agency shall employ individuals as

full-time liaisons to other agencies involved with vaccine research

and development, including DoD, NIH, FDA, CDC.

 

Sec. 2147 Definitions

 

Sec. 2148 Authorization of Appropriations $80,000,000 for the first

year, such sums thereafter.

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This is a link to an open discussion with heads of research relating to vaccines. When you scroll down, to where your cursor is a generous inch from bottom, you will see this heading.

 

STATUS OF NON-CLINICAL METHODS FOR AUTOIMMUNITY

PRESENTER: PAUL-HENRI LAMBERT, M.D.,

CHIEF, VACCINE RESEARCH & DEVELOPMENT, WHO

 

WHO =World Health Organisation

 

http://www.fda.gov/cber/minutes/tox120202.htm

 

Does anyone find this reassuring?

 

I'm just starting page 2

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SOME GOOD NEWS!!!!! Research money one step closer

 

Hi Everyone,

> >

> > We did it! The CAA passed the Senate late tonight by Unanimous

> Consent.

> >

> > We came 1/2 hour from having the bill fail to be considered by the

> > Senate because of a single Senator's objection (which would have

> made

> > unanimous consent impossible). In a last ditch effort to preserve

> all

> > that we have worked for, Senators Frist, Santorum and Enzi were

> > compelled to negotiate a reduction in the authorization of

> spending on

> > discretionary NIH autism research. Authorization of spending on the

> > environmental centers was untouched and spending on the ACE centers

> > will still double during the 5 years of the bill. The total cost of

> > the bill is now approximately 900 million instead of approximately

> 1

> > billion as passed from committee. The report and colloquy language

> > should be available within the next few days.

> >

> > This is a great and historic victory for our community for which

> > everyone on this list and our champions in the Senate, and their

> > amazing staffs, are all responsible and for which we can all be

> justly

> > proud.

> >

> > We will shortly be sending information concerning our next steps

> as we

> > prepare to pass our bill in the House of Representatives.

> >

> > We very much hope that all of our groups will find their own ways

> to

> > send their thanks to Sen. Santorum, Dodd, Enzi, Kennedy, Frist and

> Reid.

> >

> > Congratulations, everyone! Craig Snyder and Elizabeth Emken

> >

> > Elizabeth Emken

> > Board Member, Cure Autism Now

 

 

 

.

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  • 1 month later...

Guess there's quite a bit of concern in India too. :)

 

To:

HE Sri A P J Abdul Kalam,

Hon'ble President of India,

Rashtrapati Bhawan,

New Delhi.

 

Dt: 10.09.2006

 

Most Respected Sir,

 

Please accept my sincere pranam. In spite of our repeated appeals and inspite of the fact that todays edition of the Times of India states that the number of autistic children in India has crossed the 40 lakh mark, and is growing at an alarming rate, the doctors are not willing to reconsider their decision to stop the process of mass vaccinations.

 

The doctors, at the inauguration ceremony of the National Centre of Autism, inaugurated by UPA Chairperson Respected Ms Sonia Gandhi, have conceded that autism is a possible consequence of mercury poisoning. Mercury is a prime component of vaccines along with other heavy metals and neurotoxins and is also suspected to be the the prime cause behind the fact that 1 in 6 children today suffer from some sort of neurological or behavioural disorder.

 

They have also conceded that there is no cure for the condition and that prevention is the only option to stem the rapid growth of the autism epidemic all over the globe.

 

Vaccines are also said to be behind the explosion of autoimmune disorders like diabetes and cancers as they tinker with the natural immune system of the body as well as have introduced the simian virus SV 40 into humans. Vaccines are supposed to have introduced many animal viruses, 60 approximately, out of which only SV 20 and SV 40 have been identified so far.

 

Senior doctors and paediatricians have also taken pains to point out that vaccines are being introduced in India without adequate testing of the same and that this puts Indian children and growing adults at great risk of vaccines furtively designed as instruments of biological warfare as well as forcible population control.

 

Sir, we can no longer wait till the medical fraternity decides to intervene, stop vaccinations, and prevent our children from being maimed and killed. Though senior doctors have repeatedly warned the Health Ministry against the above dangers, the officials are still sleeping on the issue for reasons best known to them.

 

We have therefore decided to protect our interests by introducing a document, detailed below, to be signed by every physician, whether at their clinics, or at the vaccine camps, declaring that vaccines are safe, that they are aware of the vaccine ingredients, that they have arranged for tests ensuring their safety and also that they are sure that the particular child is at considerable risk from the disease against which the vaccine is being administered. We hope Sir, that the doctors too eager to subject our children to vaccines, will have no reason to refuse to sign such a document in the interest of the children they are so eager to "protect".

 

I plead unto you to kindly request the Health Ministry to put its seal upon the document and circulate it amongst the health officials, doctors and healthcare assistants and other professionals in charge of the vaccination process.

 

We sincerely hope Sir that your Highness will take adequate steps in this regard. Forty lakh autistic children, their parents and well wishers, as well as persons otherwise affected by vaccines, and the dead souls who have left this earthly plane prematurely due to vaccine after effects, are eagerly awaiting your early decision in this regard.

 

We have very great faith on you Sir, kindly do not let us down.

 

Most respectfully yours,

Jagannath Chatterjee,

Vaccine Damage Victim,

Health Reform Activist.

 

encl: Format of Physicians Warranty of Vaccine Safety.

 

cc: Sri Dr Manmohan Singh, Revered Prime Minister of India - With a request to

form a speacial unbiasedexpert committee to probe the role of vaccines in

childhood as well as adult autoimmune disorders

Madam Sonia Gandhi, Chairperson, UPA - Thank you Ma'am for looking into

the interests of autistic children and taking speacial efforts for their welfare.

Srimat Swami Gahananandaji Maharaj, President, Ramakrishna Math & Mission -

With pranams at your Holy Feet Sangha Guruji and seeking your blessings.

I wish to apprise your Holiness of the situation. I am an initiated devotee of

Srimat Swami Ranganathanandaji Maharaj and have learnt to love India

from Him.

Sri Somnath Chatterjee, Hon'ble Speaker, Lok Sabha.

Sri L K Advani, Leader of Opposition - With a request to kindly raise the issue

at the proper venue.

Sri Y K Sabharwal, Hon'ble Chief Justice, Supreme Court of India,

Sri Dr Anbumani Ramadoss, Hon'ble Minister of Health & FW - With a request to

kindly study the document presented and improve upon it as per needs.

Smt Panabaka Lakshmi, State Minister of Health & FW

Sri Prasanna Kumar Hota, Secretary, Department of Health,

Secretary, Department of Family Welfare,

Director, Department of AYUSH - With a request to kindly follow up.

Director, Central Council of Homoeopathy,

Director, Central Council for Research in Homeopathy - With a request to kindly

apprise the concerned officials about the alternative options of immunisation.

Dr Leo Rebello, Director, Natural Health Centre, Mumbai - To kindly follow up

with your meeting with Dr Ramadoss at Canada on the vaccine issue.

Ms Sunita Narain, Centre for Science and Environment. - To kindly widen your

investigation into mercury in vaccines to include the other heavy metals,

carcinogens, neurotoxins and contaminated serum. I am sure you will get

the required cooperation to avail of the laboratory facilities of our Govt.

Swami Ramdev, Chancellor, Divya Yoga University - With a request to suggest

alternative methods of increasing the natural immunity of the body.

Chairman, National Human Rights Commission - To kindly ensure the Right to

Life and Good Health to all the Citizen of Democratic India.

 

 

Enclosure:

Physician´s Warranty of Vaccine Safety

----------------------------------------------------------

[Designed after a similar petition submitted to the CDC, USA for consideration by

Congressmen, parents of vaccine damaged children and their legal advocates]

 

I (Physician´s name, degree)_____ _________ _________ __, _____ am a physician licensed to practice medicine in India .

My registration number is ____________ ___ .My medical specialty is ____________ _________ _ .

 

I have a thorough understanding of the risks and benefits of all the medications that I prescribe for or administer to my patients. In the case of (Patient´s name) ____________ _________ ______ , age ____________ _____ , whom I have examined, I find that certain risk factors exist that justify the recommended vaccinations. The following is a list of said risk factors and the vaccinations that will protect against

them:

 

Risk Factor/ Vaccination

____________ _________ _________ _________ _________ _____

____________ _________ ___

____________ _________ _________ _________ _________ _____

____________ _________ ___

____________ _________ _________ _________ _________ _____

____________ _________ ___

____________ _________ _________ _________ _________ _____

____________ _________ ___

____________ _________ _________ _________ _________ _____

____________ _________ ___

____________ _________ _________ _________ _________ _____

____________ _________ ___

____________ _________ _________ _________ _________ _____

____________ _________ ___

 

I am aware that vaccines typically contain many of the following fillers:

 

· aluminum hydroxide

· aluminum phosphate

· ammonium sulfate

· amphotericin B

· animal tissues: pig blood, horse blood, rabbit brain,

· dog kidney, monkey kidney,

· chick embryo, chicken egg, duck egg

· calf (bovine) serum

· betapropiolactone

· fetal bovine serum

· formaldehyde

· formalin

· gelatin

· glycerol

· human diploid cells (originating from human aborted fetal tissue)

· hydrolized gelatin

· mercury thimerosol

· monosodium glutamate (MSG)

· neomycin

· neomycin sulfate

· phenol red indicator

· phenoxyethanol (antifreeze)

· potassium diphosphate

· potassium monophosphate

· polymyxin B

· polysorbate 20

· polysorbate 80

· porcine (pig) pancreatic hydrolysate of casein

· residual MRC5 proteins

· sorbitol

· sucrose

· tri(n)butylphosphat e,

· VERO cells, a continuous line of monkey kidney cells, and

· washed sheep red blood

 

and, hereby, warrant that these ingredients are safe for injection into the

body of my patient. Reports to the contrary, such as reports that mercury

thimerosol causes severe neurological and immunological damage, are not

credible.

 

I am aware that some vaccines have been found to have been contaminated with

Simian Virus 40 (SV 40) and that SV 40 is causally linked by some

researchers to non-Hodgkin´s lymphoma and mesotheliomas in humans as well

as in experimental animals. I hereby give my assurance that the vaccines I

employ in my practice do not contain SV 40 or any other live viruses.

(Alternately, I hereby give my assurance that said SV-40 virus or other

viruses pose no substantive risk to my patient.)

 

I hereby warrant that the vaccines I am recommending for the care of

(Patient´s name) ____________ ___ ____________ _________ __ do not contain

any tissue from aborted human babies (also known as "fetuses").

In order to protect my patient´s well being, I have taken the following

steps to guarantee that the vaccines I will use will contain no damaging

contaminants.

 

STEPS TAKEN:

____________ _________ _________ _________ _________ _________ _

____________ _________ _________ _________ _________ _________ _

____

____________ _________ _________ _________ _________ _________ _

____

____________ _________ _________ _________ _________ _________ _

____

 

I have personally investigated the causes for adverse vaccine reaction and I'm sure

that the vaccines I am recommending are safe for administration to a child

under the age of 5 years.

 

The following studies have been performed to demonstrate the safety of vaccines in children under the age of 5 years.

____________ _________ _________ _________ _________ _________ _

_____

____________ _________ _________ _________ _________ _________ _

_____

____________ _________ _________ _________ _________ _________ _

_____

 

In Case of Hep B Vaccine.

"Physician´s Reasons for Determining the Invalidity of Adverse Scientific Opinions."

 

Hepatitis B

I understand that 60% of patients who are vaccinated for Hepatitis B will

lose detectable antibodies to Hepatitis B within 12 years.

I understand that 50% of patients who contract Hepatitis B develop no

symptoms after exposure.

I understand that 30% will develop only flu-like symptoms and will have

lifetime immunity.

I understand that 20% will develop the symptoms of the disease, but that 95%

will fully recover and have lifetime immunity.

I understand that 5% of the patients who are exposed to Hepatitis B will

become chronic carriers of the disease.

I understand that 75% of the chronic carriers will live with an asymptomatic

infection and that only 25% of the chronic carriers will develop chronic

liver disease or liver cancer, 10-30 years after the acute infection.

 

In addition to the recommended vaccinations as protections against the above

cited risk factors, I have recommended other non-vaccine measures to protect

the health of my patient and have enumerated said non-vaccine measures on

Exhibit D , attached hereto, "Non-vaccine Measures to Protect Against Risk

Factors."

 

I am issuing this Physician´s Warranty of Vaccine Safety in my

professional capacity as the attending physician to (Patient´s name)

____________ _________ _________ __. Regardless of the legal entity under which

I normally practice medicine, I am issuing this statement in both my

business and individual capacities and hereby waive any statutory, Common

Law, Constitutional, UCC, international treaty, and any other legal

immunities from liability lawsuits in the instant case.

 

I issue this document of my own free will after consultation with competent

legal counsel whose name is ____________ _________ ________, an attorney

admitted to the Bar in the State of ____________ ______ .

____________ _________ _________ ____ (Name of Attending Physician)

 

____________ _________ _________ ____ (Signature of Attending Physician)

Signed on this _______ day of ____________ __ A.D. ________

 

Witness: ____________ _________ _________ _____ Date: ____________ _________ ___

 

Notary Public: ____________ _________ _________ Date:

____________ _________ ___

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