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Than you Dr. Smita

As I don't have PC in my home, I am posting my discussions from office. On August 15 my office remains closed hence I posting the first post of discussion today i.e. August 14 only. Please excuse me.

Rajendra Diwe

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The Unpublished Story

It was way back in 2000, when I started my career as a Journalist with The Hitavada, I came across a hard hitting story of Hepatitis B vaccination. Mr. Atul Deshmukh, a Chartered Accountant by profession, an activist of Azadi Bachao Andolan, met me and told the black story of white jaundice. Hepatitis B in Marathi language is known as White Jaundice. Azadi Bachao Andolan in those days has launched a strong protest against the vaccination camps of Hepatitis B all over Vidarbha region. Jitendra Lodaya, Yavatmal District Co-ordinator of Azadi Bachao Andolan was in news in those days as he lodged a police complaint against the Hepatitis B vaccination camp all over Maharashtra.

Meanwhile, BAMS Graduates Association has organized a Hepatitis B vaccination camp in Shivaji Nagar in Mahal area in Nagpur. The health activist reached there and registered a strong protest against the said camp. Even Grahak Panchayat has published a ‘White Paper’ against the Hepatitis B vaccination camp. Dr. Ramesh Gautam, a leading doctor and Mahanagar Sarsanghchalak of Rashtriya Swayamsevak Sangh, also launched a protests campaign against the Hepatitis B vaccination camps. He said that Hepatitis B vaccination is a health fixing. It is a racket of cheating poor and innocent people of India.

Considering all these health activities, as a budding journalist I wanted to write a series of articles on this issue, because, none of the news papers, had published the news about these protests.

I asked my Executive Editor, he said “it is the most controversial issue. The pharmaceutical companies are very big they will finish you and our news paper also.†Still, my mind was telling me not to keep quiet. I had collected various documents. During the course, I also met one technical advisor of Food and Drugs Administration from Mumbai and he told me that the activity of Hepatitis B vaccine has not been determined.

With all the collected data about the promotional materials for the Hepatitis B Vaccines from various companies, their claims and misleading claims, the stand of health activists etc on the issue and I again contacted my executive editor, to give me a permission to write a series of articles on this issue.

My executive Editor has then asked me to write to the companies manufacturing Hepatitis B vaccine and ask the questions. “If they give satisfactory answers, then we can publish the story,†he assured.

I therefore prepared a questionnaire and faxed the same to the companies like Kline Beecham Pharmaceuticals, Panacea Biotech, Alkem Laboratories, Zydus Cadila, Sun Pharma, VHB Pharma, Intas, Bharat Serum etc. Till date, i.e. eight years have passed I have not received a single document from these companies.

On the Independence Day, I would like to start the discussion with these eight questions which I have asked to the companies manufacturing Hepatitis B vaccines.

Question 1: Is your company supplying vaccines to doctors at special price? Is there any scheme offering incentive of any kind to doctors, if they promote the vaccine? What is the justification for two prices one for doctors and one for common person?

Question 2: There are reports of Hepatitis B vaccines having dangerous side effects. A number of patients have sued the manufacturers in other countries because of these side effects. Are you aware of these? What studies have been done to determine the side effects, if any, of your products? How are patients’ fear on this count are to be allayed?

Question 3: The high risk group for Hepatitis B is same as that of AIDs. Why do the companies manufacturing vaccine then recommend it for everyone and want it included in National Immunization Programme?

Question 4: It is learnt that Hepatitis B vaccines are always imported from foreign countries in the form of genetically engineered lyophilized powders. In India only repackaging is done. Will you elaborate what are the tests of standardization followed by your company?

Question 5: Will you explain in which pharmacopoeia Hepatitis B vaccines are listed? If the Hepatitis B vaccine is not included in any of the pharmacopoeia then what are the tests of assays, analysis are followed by the company manufacturing Hepatitis B vaccine?

Question 6: How the companies determine the activity of Hepatitis B vaccine? It is learned that to determine an activity of any vaccine one has to develop antibodies out side on the culture media. Will you explain, what are the culture medias developed by company to determine activity of Hepatitis B vaccine?

Question 7: Previously the companies were saying that Hepatitis B vaccines provide immunity for 10 years with three doses of vaccination. Now they are saying that even a half dose of vaccine is sufficient to maintain immunity for more than 19 years. How did this change come about? What tests were done by your company to extent immunity?

Question 8: Previously, the price for single dose vials was Rs 350/- and now the doctors are getting the same for Rs 50/- or less. Why the prices are reduced so? The vaccines near expiry date are promoted by companies through the vaccination camps, is it true?

Since last eight years I have not received any answer for these questions. But the companies had given number of advertisements to my news paper. Also they had organized number of CMES for the promotion of Hepatitis B vaccines. Now the vaccine is one of the components of National Immuniszation Programme. Hence, Azadi bachao Andolan is no where remaining. The infants are taking Hepatitis B vaccines. Doctors in India also feel proud to give the same. And the question what is the rationale behind Hepatitis B vaccine should not be asked on Independence Day?

I am also thankful to Dr. Vijay Thawani, to open this topic again.

Rajendra Diwe

From: Dr. Smita Mali <smt_mali@...>Subject: New topic: "Rationale of Hepatitis B vaccination".netrum Date: Thursday, 14 August, 2008, 4:43 PM

Hello NetRUMians,

Here is the third discussion in the series of immunization and rationalism. I take the opportunity to welcome Mr. Rajendra Diwe hard core rationalist for the moderation of discussion "Rationale of Hepatitis B vaccination". Discussion will run from 15th Aug through 19th Aug 2008.

Welcome Rajendraji to the forum as a moderator. Take the charge of NetRUM as per schedule.

Regards,

Dr. Smita Mali

NetRUM Groupie.

Send instant messages to your online friends http://uk.messenger.

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DEar All

Mosr of teh questions asked in this are wast eof time again and again the same is being questioned when it as been proven n times that vaccines are protective and play a gerat role in public health reducing morbidity

Similar questions are posed for every vaccine being used and under prepartion

I happen toneer introduction of Hepatitis B vaccine in Inidia in AP and dealth and answered all such silly questions

The Hepatiis revalnce is more thanHIV/ AIDS in this country an d for hat matter all parts of world

her is natural antibody develpment similar tother diseases

The vaccine is most effective at birth and early weeks of life proviidng 95% immunity - antibody develpment in latre years the effect is less

It is advised for infants, childre, and high risk grous as as health personnel, soldies,police etc

Please see my response in red color

Why should any comany reply

they are kicensed to sell

WHO recommends it

people want it

Thse intrested in the answers can easily get from net or WHO site

regards

Anil

IMMUNIZE EVERY CHILD FOR HEALTHY FUTURE, PREVENT AIDS ,-PRACTICE SAFE SEX ,EAT HEALTHY FOODS SLEEP WELL , EXERCISE DAILY , MEDITATE FOR HEALTHY LIVING

From: Dr. Smita Mali <smt_mali (DOT) co.in>Subject: New topic: "Rationale of Hepatitis B vaccination" .netrumgroups (DOT) comDate: Thursday, 14 August, 2008, 4:43 PM

Hello NetRUMians,

Here is the third discussion in the series of immunization and rationalism. I take the opportunity to welcome Mr. Rajendra Diwe hard core rationalist for the moderation of discussion "Rationale of Hepatitis B vaccination". Discussion will run from 15th Aug through 19th Aug 2008.

Welcome Rajendraji to the forum as a moderator. Take the charge of NetRUM as per schedule. Regards, Dr. Smita Mali NetRUM Groupie. Send instant messages to your online friends http://uk.messenger .

Unlimited freedom, unlimited storage. Get it now

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It is very nice to have most knowledgeable Doctor participating in the discussion.He has tried to give answers to my waste of time questions but they are not complete. The company manufacturing Hepatitis B vaccine are successful in developing antibodies in culture in 2008, it is the truth.This is the reason these companies have tried Indians as a guinae pigs to test their useless Hepatitis B vaccines.

Any child can tell that a company can supply product in whole sale in low cost but how much? if a company is selling a vaccine for rs 350/- will it be able to sell to the doctor for Rs 10/- For rest of the posts I would like to add another article as follows....I am not telling the truth but some one else...

HEPATITIS B VACCINE:THE UNTOLD STORY

Parents Question Forced Vaccination As Reports of Hepatitis B Vaccine Reactions Multiply

In increasing numbers, parents across the country are contacting the National Vaccine Information Center (NVIC) to report opposition to regulations being enacted by state health department officials that legally require children to be injected with three doses of hepatitis B vaccine before being allowed to attend daycare, kindergarten, elementary school, high school or college. Simultaneously, as more schools and employers bow to pressure from government health officials and require individuals to show proof they have been injected with hepatitis B vaccine before being allowed to get an education or a job, reports of serious health problems following hepatitis B vaccination among children and adults are multiplying.

The National Vaccine Information Center (NVIC) maintains that federal and state public health officials are promoting forced vaccination with hepatitis B vaccine without truthfully informing the public about the risks of hepatitis B disease in America or the known and unknown risks of hepatitis B vaccine. Without being provided with accurate and complete information about disease and vaccine risks, citizens cannot exercise informed consent, which becomes a human right when an individual considers undergoing a medical procedure that could cause injury or death.

Following is a general overview of what is and is not known about hepatitis B disease, the hepatitis B vaccine and the politics of hepatitis B vaccination.

Hepatitis B Not Highly Contagious - Unlike other infectious diseases for which vaccines have been developed and mandated in the U.S., hepatitis B is not common in childhood and is not highly contagious. Hepatitis B is primarily an adult disease transmitted through infected body fluids, most frequently infected blood, and is prevalent in high risk populations such as needle using drug addicts; sexually promiscuous heterosexual and homosexual adults; residents and staff of custodial institutions such as prisons; health care workers exposed to blood; persons who require repeated blood transfusions and babies born to infected mothers.

According to CDC Prevention Guidelines: A Guide to Action (1997), a book written by federal public health officials at the U.S. government Centers for Disease Control (CDC), "the sources of [hepatitis B] infection for most cases include intravenous drug use (28%), heterosexual contact with infected persons or multiple partners (22%) and homosexual activity (9%)." According to on's Principles of Internal Medicine (1994), mother to child transmission of hepatitis B "is uncommon in North America and western Europe."

Although CDC officials have made statements that hepatitis B is easy to catch through sharing toothbrushes or razors, Mast, M.D., Chief of the Surveillance Section, Hepatitis Branch of the CDC, stated in a 1997 public hearing that: " although [the hepatitis B virus] is present in moderate concentrations in saliva, it's not transmitted commonly by casual contact."

Hepatitis B Not A Killer Disease For Most - Symptoms of hepatitis B disease include nausea, vomiting, fatigue, low grade fever, pain and swelling in joints, headache and cough that may occur one to two weeks before the onset of jaundice (yellowing of the skin) and enlargement and tenderness of the liver, which can last for three to four weeks. Fatigue can last up to a year. According to on's, in cases of acute hepatitis B "most patients do not require hospital care" and "95 percent of patients have a favorable course and recover completely" with the case-fatality ratio being "very low (approximately 0.1 percent)."

Those who recover completely from hepatitis B infection acquire life-long immunity. Of those who do not recover completely, fewer than 5 percent become chronic carriers of the virus with just one quarter of these in danger of developing life threatening liver disease later in life, according to Robbins Pathologic Basis of Disease (1994), a medical college textbook.

The Guide to Clinical Preventive Services (1996), written under the supervision of the U.S. Department of Health and Human Services (DHHS), states that the risk of developing a chronic hepatitis B infection is higher in infected infants than in infected older children and adults: "Infections during infancy, while estimated to represent only 1-3% of cases, account for 20-30% of chronic infections." Because infants born to infected mothers are at highest risk for developing chronic hepatitis B infections, routine screening of pregnant women for hepatitis B infection is one of the most important public health measures that can be taken to prevent chronic hepatitis B carriers. The Merck Manual (1992), a major medical reference used by physicians, notes that "postexposure vaccination is recommended for newborn infants of hepatitis B positive mothers."

Hepatitis B Low In U.S. - The U.S. and western Europe have always had among the lowest rates of hepatitis B disease in the world (0.1% to 0.5% of the general population) compared to countries in the Far East and Africa, where the disease affects 5-20% or more of the population. According to Guide to Clinical Preventive Services, in the U.S. "the greatest reported incidence [of hepatitis B] occurs in adults aged 20-39" and "the number of cases peaked in 1985 and has shown a continuous gradual decline since that time."

Even though hepatitis B disease is uncommon in the general population in the U.S., it continues to be high among those engaged in high-risk behaviors, especially IV drug use. Guide to Clinical Preventive Services states that "In recent years, a growing number of injection drug users have become infected; currently, between 60% and 80% of persons who use illicit drugs parenterally (through the skin such as with a needle stick) have serologic evidence of [hepatitis B] infection."

In 1991, there were 18,003 cases of hepatitis B reported in the U.S. out of a total U.S. population of 248 million. According to the October 31, 1997 Morbidity and Mortality Weekly Report published by the CDC, in 1996 there were 10,637 cases of hepatitis B reported in the U.S. with 279 cases reported in children under the age of 14 and the CDC stated that "Hepatitis B continues to decline in most states, primarily because of a decrease in the number of cases among injecting drug users and, to a lesser extent, among both homosexuals and heterosexuals of both sexes."

CDC Recommends All Infants Get Hep B Vaccine - Even though hepatitis B is an adult disease, is not highly contagious, is not deadly for most who contract it, and is not in epidemic form in the U.S. (except among high risk groups such as IV drug addicts), in 1991 the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) recommended that all infants be injected with the first dose of hepatitis B vaccine at birth before being discharged from the hospital newborn nursery. A similar recommendation was also made by the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP). This, despite the fact almost nothing is known about

the health and integrity of an individual baby's immune and neurological systems at birth.

In 1991, media reports generated by the CDC used hepatitis B disease statistics that were not anchored in documented fact but are still used today to promote mass hepatitis B vaccination. Most of the inflated disease statistics originate with statements generated by the Centers for Disease Control. In the 1991 ACIP Recommendations calling for mass vaccination with hepatitis B vaccine published in the Morbidity and Mortality Weekly Report, the CDC states that there are an "estimated 1 million-1.25 million persons with chronic hepatitis B infection in the United States" and that "each year approximately 4,000-5,000 of these persons die from chronic liver disease" and that "an estimated 200,000-300,000 new [hepatitis B] infections occurred annually during the period 1980-1991." The CDC gives no scientific reference for this data other than the CDC.

Just one year before the government's call for mass vaccination, hepatitis B vaccine maker Kline Beecham in their 1990 hepatitis B vaccine product insert stated, "The CDC estimates that there are approximately 0.5 to 1.0 million chronic carriers of hepatitis B virus in the U.S. and that this pool of carriers grows by 2% to 3% (12,000 to 20,000 individuals) annually."

Federal Recommendations Become State Laws - Because vaccination requirements are controlled by states and not the federal government, in order for federal health officials to achieve their goal of a 100 percent vaccination rate with new vaccines marketed by drug companies, they must persuade states to turn federal vaccine policies into state law. And, because during the past 50 years, most state legislatures have completely turned over the power to mandate vaccines to state health department officials, very infrequently do state legislators take a vote to approve the mandating of a new vaccine

such as hepatitis B. So, while American children born in 1948 were only required by state health officials to show proof of smallpox vaccination to enter school, American children born in 1998 are required by most states to be injected with 33 or 34 doses of 9 or 10 different viral and bacterial vaccines to enter school, including three doses of hepatitis B vaccine.

Federal Health Officials Give State Health Officials Money To Force Hep B Vaccination - Following the 1991 CDC recommendation for universal use of hepatitis B vaccine by all children, state health department officials began issuing mandates requiring children to show proof they have been injected with three doses of hepatitis B vaccine in order to attend daycare or school. By the end of 1997, 35 states had regulations on the books requiring children to get 3 doses of hepatitis B vaccine and, yet, only 15 states had passed laws requiring prenatal screening of pregnant mothers for hepatitis B infection.

To encourage states to mandate use of hepatitis B vaccine by all children, federal health officials at the Centers for Disease Control give grants and other financial incentives to state health departments to reward them for promoting mass vaccination. Since 1965, the CDC has given state health departments hundreds of millions of dollars through categorical grant programs to promote mass use of federally recommended vaccines. At the same time, if state health officials do not show federal health officials proof they have attained a certain vaccination rate in their state, federal grants to state health departments can be withheld.

In 1993, the Comprehensive Childhood Immunization Act of 1993 was passed giving the Department of Health and Human Services (DHHS) the authority to award more than $400 million to states to set up state vaccine registries to tag and track children and enforce mandatory vaccination with federally recommended vaccines, including hepatitis B vaccine. The Performance Grant Program rewards a state with either $50, $75 or $100 per child who is fully vaccinated with all federally recommended vaccines, including hepatitis B vaccine and, in 1995, DHHS Secretary Donna Shalala gave the states the power to approve a newborn's social security number in order to set up vaccine tracking registries in more than half the states. The CDC plan is to hook up the state vaccine tracking registries in order to create a de facto centralized electronic database containing every child's medical

records.

Pharmaceutical Industry Also Funds Forced Hep B Vaccination - In addition to federal grants, many states get money from the Wood Foundation ( & ), which operates All Kids Count, to set up vaccine tracking systems to enforce state vaccination mandates. (In 1989, Merck & Co., the U.S. manufacturer of the measles, mumps, rubella (MMR), chicken pox and hepatitis B vaccines, joined with & to form Worldwide Consumer Pharmaceuticals Co. with the goal of becoming "one of the premier worldwide consumer products companies." Merck's 1997 vaccine sales reached 1 billion dollars.)

All Kids Count is a project of the Task Force for Child Survival and Development headquartered at The Center (former President Jimmy ) in Atlanta, which is directed by former CDC director Dr. Foege. The Task Force is supported by the World Health Organization, World Bank, Rockefeller Foundation, United Nation's Population Fund and vaccine manufacturers, entities which also sponsor the Children's Vaccine Initiative (CVI). The CVI, headquartered in Geneva, was launched in 1990 at the World Summit for Children and promotes "the development and utilization" of vaccines by all of the world's children.

Forced vaccination with hepatitis B vaccine is also promoted in states by non-profit organizations such as Every Child by Two, founded in 1991 by former First Lady lyn and Betty Bumpers, wife of Arkansas Senator Dale Bumpers. Every Child by Two is funded in part by grants from Merck, Lederle and Connaught, the three largest U.S. vaccine manufacturers.

The non-profit CDC Foundation, which began operation in 1995, has raised more than $15 million in the past four years to augment the CDC's campaign to enforce mass vaccination. The CDC Foundation, the Task Force for Child Survival & Development and vaccine manufacturers funded the recent National Immunization Conference held in Atlanta.

The five-year-old non-profit Immunization Action Coalition operates the Hepatitis B Coalition, which nationally promotes hepatitis B vaccination for all children. Funding comes from private donations, including a grant from Kline Beecham, manufacturer of the hepatitis B vaccine, and a new $750,000 grant from the Centers for Disease Control. A newsletter produced by this group contains the assurance that "Everything herein is reviewed by the Centers for Disease Control and Prevention for technical accuracy (unless it is an opinion piece written by a non-CDC author)."

Pharmacists Now Vaccinate - Kline Beecham, through the American Pharmaceutical Association, has also funded a nationwide campaign called "Pharmacy-Based Immunization Advocacy" which allows pharmacists to vaccinate children and adults. As of 1998, the Hepatitis B Coalition reports that 23 states have passed laws giving pharmacists the right to sell and administer hepatitis B and other vaccines.

Families Penalized For Refusing Hep B Vaccine - As state health departments accumulate power and money to force vaccination with all federally recommended vaccines, including hepatitis B vaccine, child and adult citizens are punished by both federal and state health officials with economic sanctions for refusing to comply. Refusal to be injected with hepatitis B vaccine can result in citizens being denied an education, including enrollment in daycare, elementary school, high school, college and graduate school; denial of health insurance; denial of employment; denial of federal entitlement benefits for poor children including food under the Women, Infants and Children (WIC) program and medical care under Medicaid. In some states, like Texas, a needy family loses $25 per month per child in state health benefits if all children have not received all federally recommended vaccines, including hepatitis B vaccine.

Hep B Vaccine Licensed By FDA Without Adequate Proof of Long Term Safety - In 1986, the FDA gave Merck & Co. a license to market the first recombinant DNA hepatitis B vaccine, which replaced the old hepatitis B vaccines made from blood taken from human chronic hepatitis B virus carriers. In awarding Merck & Co. and, later, Kline Beecham Pharmaceuticals, licenses to market their genetically engineered hepatitis B vaccines in the U.S., the FDA allowed both drug companies to use "safety" studies which only included a few thousand children monitored for only four or five days after vaccination to check for reactions. As "proof" their hepatitis B vaccine is safe to be used in children, Merck & Co. stated in their 1993 product insert that "In a group of studies, 1636 doses of

RECOMBIVAX HB were administered to 653 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose."

Merck & Co. found that injection site and systemic complaints, such as fatigue and weakness, fever, headache and arthralgia (joint pain), were reported following up to 17 percent of all hepatitis B injections. Because the FDA did not require drug companies to provide scientific evidence that hepatitis B vaccine does not compromise the immune and neurological systems of children and adults over weeks, months or years post-vaccination, Merck & Co. warns in the 1996 product insert that "As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials" and Kline Beecham (1993) has a similar warning that "it is possible that expanded commercial use of the vaccine could reveal rare adverse reactions.

Another warning in the Merck 1996 product insert is "it is also not known whether the vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity" and "it is not known whether the vaccine is excreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when the vaccine is administered to a nursing woman."

And, although doctors routinely inject hepatitis B vaccine into children along with many other vaccines such as DPT, HIB, MMR and chicken pox vaccine, Merck & Co. state in the 1996 product insert: "Specific data are not yet available for the simultaneous administration of RECOMBIVAX HB with other vaccines."

Hep B Vaccine Efficacy Also Questioned - All vaccines stimulate only an artificial, temporary immunity, and the length of immunity conferred by the hepatitis B vaccine and the future need for more "booster" doses later in life is still not clear. Merck & Co state in their 1996 hepatitis B vaccine product insert that "the duration of the protective effect of RECOMBIVAX HB in healthy vaccinees is unknown at present and the need for booster doses is not yet defined."

In the CDC Prevention Guidelines: A Guide to Action (1997), the CDC states "The duration of protection [of hepatitis B vaccine] and need for booster doses are not yet fully defined. Between 30% and 50% of persons who develop adequate antibody after three doses of vaccine will lose detectable antibody within 7 years but protection against viremic infection and clinical disease appears to persist." If immunity only lasts 7 years, babies vaccinated with hepatitis B vaccine may be candidates for more shots at age seven.

IOM Report Reveals Lack Of Adequate Scientific Studies - In Adverse Events Associated with Childhood Vaccines published in 1994 by the Institute of Medicine, National Academy of Sciences, observations about the limitations of hepatitis B vaccine studies included the statements that "it is important to note that individual trials usually involved a few hundred subjects for study...when larger vaccination programs were monitored, observations of adverse events were necessarily less detailed and less accurately reported" and "the studies were not designed to assess serious, rare adverse events; the total number of recipients is too small and the follow-up generally too short to detect rare or delayed serious adverse reactions."

The IOM report also noted that no controlled observational studies or controlled clinical trials have ever been held to evaluate repeated reports that hepatitis B vaccine can cause Guillain-Barre syndrome; arthritis; transverse myelitis, optic neuritis, multiple sclerosis and other central demyelinating diseases of the nervous system (degeneration of the myelin sheath of the brain that helps transmit nerve impulses); or sudden infant death syndrome (SIDS).

A major conclusion of the Institute of Medicine report was that almost no basic science research has been undertaken to define at the cellular and molecular level the biological mechanism of vaccine-induced injury and death. The report concluded that "The lack of adequate data regarding many of the adverse events under study was of major concern to the committee...the committee encountered many gaps and limitations in knowledge bearing directly or indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunization, insufficient or inconsistent information from case reports and case series...and inadequate size or length of follow-up of many

population-based epidemiologic studies…."

Medical Literature Cites Immune System/Brain Damage - During the past decade, there have been many reports in the medical literature (primarily in international medical journals rather than U.S. medical journals) that hepatitis B vaccination is causing chronic immune and neurological disease in children and adults, including lupus: Tudela & Bonal (1992); Mamoux & Dumont (1994); Guiserix (1996); arthritis, including polyarthritis and rheumatoid arthritis: Christan & Helin (1987); Hachulla et al (1990); on & Nye (1990); Biasi et al (1993),(1994); Vautier & Carty (1994); Hassan & Oldham (1994); Rheumatic Review (1994); Gross et al (1995); Pope et al (1995); Cathebras et al (1996); Soubrier et al (1997); Guillain Barre Syndrome

GBS): Shaw et al (1988), Tuohy (1989); demyelinating disorders such as optic neuritis, Bell's Palsy, demyelinating neuropathy, transverse myelitis and multiple sclerosis: Shaw et al (1988); WHO (1990); Reutens et al (1990); Herroelen et al (1991); Nadler (1993); Brezin et al (1993); Mahassin et al (1993); Kaplanski et al (1995); Baglivo et al (1996); Marsaudon & Barrault (1996); Berkman et al (1996); Waisbren (1997); diabetes mellitus: Poutasi (1996); Classen (1996); chronic fatigue: Salit (1993); Delage et al (1993); vascular disorders: Fried et al (1987); Goolsby (1989); Cockwell et al (1990); Poullin & (1994); Mathieu et al (1996); Graniel et al (1997); and others.

In 1996, Burton A. Waisbren, M.D., a cell biologist and infectious disease specialist, who is a founding member of the Infectious Disease Society of America and past President of the Infectious Disease Society of Milwaukee, pointed out in the Wisconsin Medical Journal that "there is an increasing number of reports in the refereed medical literature about demyelinizing diseases occurring after an individual has received the hepatitis B vaccination...since the hepatitis B virus itself has been reported to cause autoimmune problems, should we not be wary of giving antigens that seem to have triggered these problems?" Waisbren, in a presentation before a 1996 Institute of Medicine Vaccine Safety Forum, warned

that genetically engineered hepatitis B vaccines contain polypeptide sequences that are present in human neurologic tissues such as myelin and that, by a mechanism called molecular mimicry, these polypeptides can act as autoantigens which can induce autoimmune demyelinating diseases of the brain such as multiple sclerosis.

In that same year, Montinari et al published a study in Italy evaluating 30 children and adults, the majority aged 3 to 9 months, who suffered central nervous system disorders, such as seizures and autism, following hepatitis B vaccination. The purpose of the study was to investigate whether there is an immunogenetic basis (autoimmune type) responsible for the demyelination process in the brain that can occur following recombinant hepatitis B vaccination. The authors concluded "autoimmune diseases are more frequent in nations where vaccines are widely used, the so called "clear" communities" and they identified several potential genetic markers that "may visualize risk patients for autoimmune diseases following hepatitis B vaccination.

Montinari's work to identify genetic factors for predisposition to hepatitis B vaccine reactions is important in light of the study in 1989 by Alper et al to identify genetic factors for those who do not respond to hepatitis B vaccination. In that study, the authors concluded that there was genetic predisposition to failure to respond to the vaccine. They stated: "These results support our hypothesis that the production of anti-HBsAg [vaccine-induced antibodies] is a dominant trait and that the inability to produce high titers of anti-HBsAG after adequate immunization is a recessive trait..." The authors concluded that the genetic markers they identified are most prevalent in caucasians of European descent "and is associated with a wide variety of diseases with autoimmune features in this population, including Type 1 diabetes mellitus..."

In 1996, Barthelow Classen, M.D., CEO of Classen Immunotherapies Inc., published an epidemiologic study in the New Zealand Medical Journal and reported that there was a 60 percent increase in Type 1 diabetes (juvenile diabetes) following a massive campaign in New Zealand from 1988 to 1991 to vaccinate babies six weeks of age or older with hepatitis B vaccine. His analysis of a group of 100,000 New Zealand children prospectively followed since 1982 showed that the incidence of diabetes before the hepatitis B vaccination program began in 1988 was 11.2 cases per 100,000 children per year while the incidence of diabetes following the hepatitis B vaccination campaign was 18.2 cases per 100,000 children per year.

Vaccine Injuries Reported At NVIC Conference on Vaccination - At the First International Public Conference on Vaccination sponsored by the NVIC on September 13-15, 1997 in andria, Virginia, physicians and scientists from around the world gathered to speak about vaccine-induced chronic illness. Canadian physician Byron Hyde, M.D., Chairman of the Nightingale Research Foundation, and an internationally recognized authority on myalgic encephalomyelitis (also known as chronic fatigue syndrome), spoke about the data he has accumulated on more than 200 cases of serious immune and neurological dysfunction following hepatitis B vaccination. Dr. Hyde said:

"There was a nurse in Wisconsin who had had two immunizations against hepatitis B. After the second, she started to complain. They insisted that she have three more [shots], full dosage. They gave her the first, she complained of headaches, pain, and they told her this was anxiety neurosis. They gave her the fourth and fifth and she lost I.Q., measurable loss of intelligence, measurable loss in stamina, all of the things you see in the worst cases of ME or chronic fatigue syndrome.....A lot of these cases that we've looked at suggest demyelinating disease, disseminated myelitis, localized injuries, three unexplained deaths...the problem with all of this is that nobody has ever seriously studied it...."

Dr. Hyde was particularly critical of the poor science and medicine that hurts patients. He concluded "Almost all of these people who had adverse reactions after the first immunization, after the second immunization were individuals who had immunological side effects and who told their physicians and the physicians did nothing about it but continued to proceed with immunization... I think part of the problem is the pharmaceutical companies and the governments themselves have attempted to say 'Here, take this sugar pill, it is danger-free, it is a wonderful thing, it has no risk, no problems' and doctors have become lazy and actually believed this dangerous philosophy put out by the pharmaceutical companies and the governments."

Hep B Vaccine Infant Deaths Reported In VAERS - Even though fewer than 10 percent of all doctors report health problems following vaccination, there are more than 16,000 reports of hospitalizations, injuries and deaths following hepatitis B vaccination that have been reported to the U.S. government Vaccine Adverse Event Reporting System (VAERS) since July 1990. There are reports of deaths in infants under one month of age following hepatitis B vaccination in VAERS, with most of the deaths being classified as sudden infant death syndrome (SIDS), even though SIDS is not historically recognized in the medical literature as occurring in babies under two months of age.

One of those death reports was made for a 15-day old baby boy who died within 48 hours of his first dose of hepatitis B vaccine. His father testified at a 1995 Institute of Medicine Vaccine Safety Forum workshop. He described what happened:

"For the first 13 days of his life, was no different than any other baby. He ate well. When he slept, he slept well. He acted just like my first son acted when he came home from the hospital." was given a hepatitis B shot at his regular check up at the pediatrician's office on the 13th day of his life. His father said:

"That night when I got home from work, I noticed that was crying a lot more than usual. In fact, he was screaming some of the time. He was acting differently, but because we had just taken him to the doctor for a checkup and they told us he was a big healthy boy, we thought everything was OK. When he was just acting fussy, like babies sometimes do, we didn't know anything about vaccines or that they can cause problems for some babies."

" cried on and off for most of the night. When I got up and went to work the next day, he was still crying on and off. He continued during most of the day and into the evening. The next morning, his mother found him dead in his crib. From the way he looked, he had been dead for several hours."

An autopsy was done the next day. A couple of weeks later, our pediatrician told us over the phone that the autopsy showed had died of sudden infant death syndrome. He told us was one of the healthiest babies he had ever seen…. What I didn't know then but I know now is that the pediatrician had made a report within 17 days of ' death to the government's Vaccine Adverse Event Reporting System, VAERS. In VAERS, ' death is listed as SIDS. Even though I didn't know anything about vaccines or SIDS, something told me that there was a reason why died, and I had to find out why."

After seeing an article in the Washington Post about the Institute of Medicine report on adverse events associated with childhood vaccines, 's father called the National Vaccine Information Center and began talking to experts and researching infant death and vaccines. Eventually a clinical professor of pathology, who had reviewed ' medical records, autopsy and slides, stated in writing that did not die of SIDS but died a cardiac death, caused by passive congestive changes with pulmonary edema and hemorrhage caused by the active immunization with hepatitis B vaccine. The

pathologist stated "I do not believe this was a sudden infant death syndrome death. Sudden infant death syndrome is the most abused diagnosis in pediatric pathology. In this particular case, the infant was two weeks old. Sudden infant death at two weeks old is so rare as to be virtually unheard of."

The pathologist went on to say that was at high risk for congestive heart failure because his mother had gestational diabetes, but that he would definitely have survived were it not for the stress induced by the hepatitis B vaccination.

's father, in his testimony before the Institute of Medicine, asked "How many other newborn babies are dying from the effects of hepatitis B vaccine, but are being wrongly diagnosed as SIDS and no one ever knows the difference? I looked at the computer printouts of VAERS reports at the National Vaccine Information Center, and I saw there were other reports of babies just a few days or weeks old, who have died shortly after hepatitis B vaccination. Many are listed as SIDS deaths, but are they?"

Adults Report Hep B Vaccine Injury And Death To NVIC - As hepatitis B requirements force more adults to get vaccinated as a condition for getting a higher education or working in the health care field, NVIC is receiving more and more reaction reports like this one from a disabled nurse, who recently wrote in:

"24 hours after my first [hepatitis B] shot, I had muscle pain in legs and arms - was told this was 'normal.' Same thing after 2nd shot. Six weeks after 2nd shot I had my first episode of Raynauds [temporary loss of blood flow to fingers resulting in tingling, throbbing, swelling, intense pain] and also began having rashes on arms and neck. At this point it was minor and not constant. I asked if it had anything to do with the vaccine and was told no.

"Six months after the 1st shot, I received the booster. From then (1995) to today, I have constant daily fevers up to 100.5, tormenting rashes and prickling on arms, hands, neck and legs, muscle degeneration, joint pain with restricted movement, difficulty swallowing and Raynauds has become severe.

"I was perfectly healthy until the hepatitis B vaccinations and still all the doctors tell me it has nothing to do with my illness. I had reactions to two of the drugs they tried to treat me with. I am on total disability because of these symptoms. I am an RN but was taught that the vaccines were perfectly safe."

Parents Oppose Hepatitis B Vaccine Mandate In Illinois - In the spring of 1997, a suburban Chicago mother of two daughters, ages 9 and 11, became concerned when she received a notice from the school system stating that her older daughter had to be vaccinated with hepatitis B vaccine by September 1997 or she would be barred from attending school. Although both of Kathy Rothschild's daughters were fully vaccinated with all other childhood vaccines, she didn't know anyone with hepatitis B and couldn't understand why her daughter had to get the vaccine. Her research led her to a public library and then to NVIC.

With the help of Kathy Rothschild's State Senator, Kathy , an agreement by the Illinois Department of Health to not voice opposition, and with support from NVIC members around the state, a bill passed the Illinois Senate 52-2 on March 20, 1997, allowing parents the right to philosophical exemption to vaccination. The bill also created a Task Force and required the Board of Health to hold public hearings to review how Illinois public health employees add new vaccines to state vaccination laws and how they implement those laws.

After the bill overwhelmingly passed the Senate, the Illinois Department of Health went back on its pledge not to oppose the bill and vigorously fought against the bill in the House, successfully killing it in committee before it had a chance to come to a floor vote. However, the health department did agree to roll back the hepatitis B mandate for one year (until September 1998) and to hold three public hearings, which resulted in testimony from physician expert witnesses and parents and reinforced the dangers of hepatitis B vaccine and the need for informed consent rights to be established within state vaccine requirements.

Doctor, Mothers Say Vaccine Safety Data Poor - In a December 1997 public hearing in Chicago before the Illinois Board of Health, Mayer Eisenstein, M.D., M.P.H., who is board certified in public health and preventive medicine, quality assurance utilization review, by the National Board of Medical Examiners and has recently completed a law degree, testified against the proposed hepatitis B mandate. He said: "The idea of giving this vaccine to a one-day old baby, a newborn, is preposterous. There is no scientific evidence for this. In fact, I called up the [hepatitis B vaccine] manufacturer and I had [a representative] come to St. of Nazareth Hospital, where I am Chairman of the Department of Medicine, and I asked

him: ‘Show me your evidence on one-day old infants as to side effects [from the hepatitis B vaccine]’ – we have none. Our studies were done on 5 and 10 year olds....As a father, grandfather, a physician, as a lawyer, I want the option of not giving it to my children unless I believe the scientific evidence is there."

Later during the public hearing, a mother whose child reacted to the hepatitis B vaccine testified that "We were told unless we had the shot our children were not getting into school. In the past, I got the shots for my children. So I went and got the [hepatitis B] shot. First shot, my daughter got slightly sick. We didn't associate it with the shot. We associated it with possible flu. Her legs hurt. Her back hurt...."

"The second shot, within two days of this shot, my daughter's symptoms went from mild to severe abdominal pain around the clock. She couldn't eat. She couldn't sleep. Her legs hurt. She broke out in a rash. She had eczema over most of her body. Going to the doctor, we were told it was in her head, that she needed a psychiatrist. Then we decided we would find out for ourselves.

"It was the people who gave me [information on the vaccine], the list that I should have gotten first that said what the reactions were, including severe abdominal pain, eczema, rash, hair loss. My doctor didn't tell me that. I was given a piece of paper that said reactions would be a minimum, maybe a small fever. She had a fever the whole time.

"I never knew any of this existed, and this is $18,000 later, a child who [had to be] out of school for the first three months and was tutored at home. I don't want to see other kids go through this. I think there should be more testing done. I think the parents should know that this shot isn't for something that's easily picked up. This is for sexual transmission or drug use. My child is ten years old. She plays with Barbie dolls and paints her fingernails. She doesn't know about this stuff. I don't want to give her a shot to protect her from something and someplace she's not at yet."

Citizens Make Plea for Informed Consent - Before testifying at a Board of Health public hearing held in Springfield on March 26, 1998, NVIC held a press conference in the State Capitol building. Then, along with scores of Illinois parents who traveled to Springfield to make public comment, NVIC President Barbara Loe Fisher Reverend VandenBosch, President of the American Research Foundation, and Bonnie Dunbar, Ph.D., professor of cell biology at Baylor College of Medicine in Houston, presented formal testimony.

Fisher told the Board of Health "There is a six year old girl named lying in a bed in Skokie, Illinois unable to lift her head off her pillow or walk to the bathroom. Just 13 weeks ago, was an ice skater with boundless energy and a dream of going to the Olympics. Her mother didn't want her to get the hepatitis B shot but her pediatrician told her it was a political issue like AIDS and the American Academy of Pediatrics (AAP) was going to mandate the vaccine soon. got that hepatitis B shot and now she may never skate again. Where were her informed consent rights? And where will the doctors from the state health department and the CDC

and the AAP be when her mother carries her up the stairs to the bathroom? And will the state of Illinois pay her medical bills when her insurance runs out after DHHS and the Justice Department oppose giving her federal compensation?"

During limited public comment time, all of the parents asked the Board of Health to allow citizens to follow the judgement of their conscience when making vaccination decisions for their children, including the right to exercise informed consent to vaccination without suffering harassment and punishment at the hands of state health and school officials. Some, like a young man who was kicked out of an Illinois college in the middle of the semester because of his sincere religious beliefs, asked for the right to follow his religious convictions without being punished by doctors employed by the state. He said:

"They have refused to give me credit for this semester and have told me not to attend class and have cancelled my appointment with my advisors. I applied for a religious exemption. Both my parents wrote letters identifying my objection. We were refused on the grounds that, in order for a religious exemption to occur, I must identify 'a recognized church or religious organization.' I don't believe that anyone has a right to judge my religion. How does recognition of my belief by another human being make it more or less? I am confused by the word 'organized.' How does the number of people or the structure under which they operate validate my beliefs? This is a violation of my Constitutional right to religious freedom."

Rev. VandenBosch, an ethicist, warned that "The First Amendment [of the U.S. Constitution] clearly defines the free exercise of religious beliefs and the moral rights of individuals to obey the judgement of their conscience in matters of life and death. The Ninth Amendment of the Constitution guarantees that governmental authority cannot override individual rights of conscience. It states: 'The enumeration of the Constitution of certain rights shall not be construed to deny or disparage others retained by the people.' One of the rights retained by the people is the right of conscience."

Professor Of Cell Biology Investigates Hep B Vaccine Damage - Professor Bonnie Dunbar, Ph.D., who has a distinguished 25 year career in academic and laboratory science and has been honored by the U.S. National Institutes of Health (NIH) for her pioneering work in contraceptive vaccine development, presented at the March 26 Illinois Board of Health hearing and described disabling reactions to hepatitis B vaccine suffered by her brother and a research assistant.

"Three years ago my brother, who is a geologist Ph.D. agronomist with four college degrees, came to work with me at Baylor College of Medicine to work on a collaborative project in molecular genetic engineering of wheat proteins. He was required to take the hepatitis B vaccine. Within 24 hours to four days after the first injection, he had fever and severe fatigue for one week. Two to four weeks after that injection, he ended up with a whole series of symptoms that now 15 doctors have said are clearly symptoms of an adverse reaction to this vaccination. Even workman's compensation for the state of Texas is compensating him for over $300,000 worth of medical expenses."

"At about the same time, a 21-year old girl, a medical student, came to work in my lab for the summer, She, too, had to get the hepatitis B vaccine. After the first injection, she had fever and fatigue. Three weeks following her second injection, she lost vision in her one eye but, after 6 months, regained most of her sight. She was reluctant to get the third dose of vaccine, and talked with her doctor and he told her this [hepatitis B] vaccine is the safest, there's no problem. After the third injection, she ended up in the hospital for two months extremely ill and she has lost all of her eyesight in one eye."

Dr. Dunbar went on to explain to the Board of Health members that during the past three years of collecting data on the hepatitis B vaccine, she has been contacted by hundreds of doctors and patients around the world who have reported severe autoimmune and neurological complications to hepatitis B vaccination in previously healthy children and adults, including serious rashes, fever, joint pain, chronic fatigue, multiple sclerosis and lupus-like symptoms, rheumatoid arthritis and neurological dysfunction. As a basic science researcher with expertise in cell and molecular biology, she is investigating the possibility that molecular mimicry or other autoimmune mechanisms may be the reason why the genetically engineered hepatitis B vaccine "tricks" the immune systems of genetically susceptible individuals into attacking their own bodies, causing debilitating autoimmune

disorders.

After analyzing the data she has accumulated, Dr. Dunbar, in collaboration with colleagues at other academic and medical institutions, applied for a NIH research grant to investigate the role that genetic factors may play in hepatitis B vaccine reactions and in vaccine failures. Their goal is to identify genetic markers so high risk children and adults could be screened out of the mass vaccination program and spared injury and death. The grant was turned down twice by the government in July 1997 and July 1998 but Dr. Dunbar and her colleagues are in the process of refiling the grant, along with additional data.

Hep B Vaccine Victims In France Sue - An article in the July 31, 1998 issue of Science, an American scientific journal, reports that French attorneys representing 15,000 French citizens filed a lawsuit against the French government "accusing it of understating the vaccine's risks and exaggerating the benefits for the average person." One French physician has reportedly collected data on more than 600 people suffering from serious immune and neurological dysfunction following hepatitis B vaccination, many with symptoms resembling multiple sclerosis. Science quotes a World Health Organization official as saying "These fears [of the hepatitis B vaccine] are quite unfounded" and reveals that CDC employee

Chen, who is responsible for monitoring vaccine safety for the U.S. government, has a simple explanation for the growing number of reports of hepatitis B vaccine associated injury and death in the U.S., Canada and Europe. His scientific analysis leads him to believe that "It's human nature to attribute cause to almost anything that precedes a tragedy."

Hep B Vaccination Can Mean A Positive Hep B Blood Test - A little known fact about hepatitis B vaccine is that those who are vaccinated can test positive for hepatitis B on some routine blood tests. NVIC has received calls from adults who report that, after getting hepatitis B vaccine, they are testing positive for hepatitis B when they undergo routine blood tests in doctor's offices. The Red Cross maintains that more sensitive lab tests used by blood banks can differentiate between hepatitis B antibodies produced by disease and those produced by the vaccine.

HIV vaccines now being tested in humans also produce positive tests for HIV. As noted in a September 1997 Washington Post article about HIV vaccine trials: "Foremost among the worries of many would-be volunteers is the problem of forever testing positive for AIDS antibodies...although sophisticated laboratory tests can usually tell the difference between AIDS antibodies caused by a vaccine and those that indicate a real HIV infection, few laboratories are equipped to make that distinction. Moreover, as vaccines get better by more closely mimicking the real infection, it will become more difficult to distinguish between the two."

Is Forced Hepatitis B Vaccination Paving Way For Forced Vaccination With AIDS Vaccine?Hepatitis B is the first disease transmitted not by casual contact like smallpox or polio, but by high risk behavior such as IV drug use and sexual promiscuity, that has been mandated for use by all children. With the identical transmission routes as HIV, there are strong indications that forced vaccination of infants and children with hepatitis B is just a trial run for forced vaccination with an AIDS vaccine when it is put on the market in the next few years. AIDS vaccines are currently in human trials as a race to bring them to market intensified after a call last year by President Clinton to make the creation and use of an AIDS vaccine "a national mission."

CDC Plans For Mass Vaccination Of All Children With AIDS Vaccine – In a February 12, 1997 meeting of the CDC's Advisory Committee on Immunization Practices (ACIP), Neal Halsey, M.D., chairman of the American Academy of Pediatrics (AAP) Committee on Infectious Diseases, AAP liaison member of the ACIP and Director of the Institute of Vaccine Safety at 's Hopkins University, reminded HIV vaccine researchers and developers at the meeting that the CDC plans to target 11 to 12 year old children for "universal application" of an HIV vaccine. Halsey told them:

"One of the things that's happened in the past with vaccines is that sometimes the manufacturers have developed them and tested them primarily in an age group or a population which may not be the final target population that this committee has considered. Over the last few years we have developed a statement on adolescent immunization and it probably would be worth your reading that, and others, because we really see age 11 to 12 as the target age for introduction of vaccines for prevention of sexually transmitted diseases. And I know that, at this time, you are really studying adults and you're also some distance away from the actual - having a [HIV] vaccine in hand that might be licensed and approved - but at least it would be nice if there were studies that were planned in parallel when you move another step in the direction of actually having a candidate vaccine,

realizing where WE think we would want to use universal application of such a vaccine. And so I think maybe [you should get] a copy of the adolescent immunization statement."

With the Children's Vaccine Initiative (CVI) and pharmaceutical industry setting up the mechanism for global mass vaccination of children and adults, including the creation of national and international vaccine tracking systems, countries with low HIV rates like the U.S. and Europe will be forced to use an HIV vaccine in order to pay for the vaccination of populations in Asia and Africa where HIV infection rates are skyrocketing. In 1996, HIV vaccine developer Stanley Plotkin, M.D., of Pasteur Merieux Pharmaceuticals (who developed the rubella vaccine and has been a vaccine policymaker member of the AAP Committee on Infectious Disease and AAP liaison member of the ACIP) explained why mandatory vaccination in rich countries like the U.S. help deliver vaccines to Third World

markets:

"The keystone of the [global mass vaccination] system is that the research costs [of drug companies] are recouped in North America and Europe and the vaccines are sold in the developing world at much, much lower margins...the relatively high rate of childhood vaccination seen lately in most parts of the world is the result of that system," explained Plotkin.

CDC Tells Congress About Future Vaccines - In testimony before the U.S. Senate Committee on Labor and Human Resources in 1997, CDC official Walter Orenstein, M.D., made a bid to persuade Congress to reauthorize 288 million dollars for the CDC's Immunization Grant Program in the $427 million 1998 DHHS budget request for immunization activities. In a review of the history of vaccination, Dr. Orenstein recounted that, although almost a century passed between the development of the smallpox vaccine in 1796 and that of the rabies vaccine in the 1880's, by the middle of the 20th century there were nearly two dozen vaccines on the market.

Painting a picture of the future, Orenstein said: "On the horizon are vaccine technologies that would have been considered science fiction just a decade ago, but are now reported at scientific meetings. Snippets of synthetic DNA have worked as experimental vaccines in animals. Edible plants have been bioengineered to become vaccine factories....vaccines have been enclosed in microscopic capsules, permitting them to be released slowly over time..."

Orenstein reminded legislators that "Every day about 11,000 babies are born in this country. Each of these children starts with immunization coverage of zero. There is why our responsibility to our Nation's children never ends; it must be sustained every day of every year....completing state-based immunization registries is the cornerstone of assuring disease prevention."

Vaccine Registries To Tag, Track, Force Vaccination - Even though CDC officials admit that there is already a 96 percent vaccination rate in the U.S. with federally recommended vaccines, they are setting up state vaccine tracking registries and plan to link them together to create a de facto national electronic tracking system to ensure mass compliance with federal vaccine policies. Citizens will be tagged with a number at birth and tracked even when moving from state to state.

In 1995, DHHS Secretary Donna Shalala appropriated the social security numbers assigned to newborns to allow states to enter all babies in state vaccine tracking systems. In 1996, the Health Insurance Portability and Accountability Act (HIPAA), also known as the Kennedy-Kassebaum legislation, outlined plans for a "unique health care identifier" number, which is an alternative to the social security number, to be assigned to citizens at birth and electronically monitor their medical records, including vaccination records.

In a 1998 CDC publication entitled Initiative on Immunization Registries, the CDC states that "we see [vaccine] registries as a possible first step in the development of an electronic pediatric record" and "computerized registries will eventually be capable of capturing immunization for individuals of all ages" and "until a unique personal identifier can be established on a national basis, multiple means of identification must be used [in state vaccine registries]." Core data that is now collected in many state vaccine tracking systems include a citizen's name, address, phone number, social security number, birth date, sex, race, primary language, patient birth order, patient birth registration number, patient Medicaid number, mother's name (including maiden name) and social security number and father's name and social security number.

Most often state officials automatically enroll newborns into the vaccine registry without informing parents or giving them the right to "opt-out" of the registry. In the state of Texas, PROVE, a parent group led by Dawn , worked to get legislation passed in 1997 requiring the state health departments to obtain a parent’s prior written consent to enroll a child in a vaccine registry.

The CDC goes on to state that one of their main goals is "establishing a target date to achieve the goal of establishing immunization registries in every community in the Nation" and "promoting the inter-operability of registries with other developing medical information systems" and "promoting the automated exchange of immunization records between registries."

What You Can Do - If you want to make informed, voluntary decisions about hepatitis B vaccination, there are several actions you can take to educate your community and protect your informed consent and privacy rights. Circulate this newsletter in your community among your family, friends, and neighbors. Get reprints by sending in the enclosed reprint order card. Reprints are available for $1.25 each. Bulk pricing is available. Give copies to your doctors, lawyers, teachers, school principals, nurses and others. Send a copy to your favorite newspaper, radio and TV station. Send a copy to your state and federal legislators with a personal letter. Report vaccine reactions by calling NVIC at 1-800-909SHOT or accessing

NVIC's website at www.nvic.org. If you are pregnant, get tested for hepatitis B disease. If you are infected, your baby is a candidate for vaccination. Stand up for your informed consent rights. If you do not test positive for hepatitis B; do not fall into one of the high risk categories described in this newsletter; and decide you do not want your newborn vaccinated before leaving the hospital newborn nursery, you can amend the "consent for medical treatment" forms you sign upon entering the hospital before giving birth by writing on the form that you do not give consent for hepatitis B vaccination of your baby in the hospital. Check to see if your state has a vaccine tracking system and, if you do not want your baby enrolled in a tracking system, find out how you can exercise your informed consent rights. Get more information, including checking your state vaccination laws for requirements and exemptions. Hepatitis B vaccine is required in 35 states.

There are medical exemptions in all states, religious exemption in all but two states (West Virginia and Mississippi) and philosophical exemption in 16 states. Don't let anyone intimidate or coerce you into taking action before you have had the opportunity to become fully informed about all your options and are comfortable with your vaccination decision.

From: Dr. Smita Mali <smt_mali (DOT) co.in>Subject: New topic: "Rationale of Hepatitis B vaccination" .netrumgroups (DOT) comDate: Thursday, 14 August, 2008, 4:43 PM

Hello NetRUMians,

Here is the third discussion in the series of immunization and rationalism. I take the opportunity to welcome Mr. Rajendra Diwe hard core rationalist for the moderation of discussion "Rationale of Hepatitis B vaccination". Discussion will run from 15th Aug through 19th Aug 2008. Welcome Rajendraji to the forum as a moderator. Take the charge of NetRUM as per schedule. Regards, Dr. Smita Mali NetRUM Groupie. Send instant messages to your online friends http://uk.messenger .

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Dear all,

The problem of Hep B vaccine is not it's efficacy or safety. The problem is cost-efficacy because of which it should not be introduced into the National Programme of immunization as it would be a waste of Public Funds to spend money for such a low priority issue and for such high cost. I am pasting below a letter we sent to the Health Minister two years back, with no resonse!

Attached is an excellent, recent review paper by J. Puliyel et al.

With Regards,Sincerely Yours,

Anant Phadke

Anant and Sandhya Phadke,8, Ameya Ashish Society, Kokan Express Hotel Lane,Kothrud, Pune 411038

Phone - 020 25460038Anant - 9423531478Sandhya 9822399458

To,

The Minister

Ministry of Health & Family Welfare

Government of India

Nirman Bhavan

New Delhi-110011

Dear Dr. Ramadoss,

Through the news in the Times of India (6th September) ‘Hepatitis-B threat bigger than AIDS’ we came to know about the decision of the health ministry to launch the programme throught India to give hepatitis B vaccine to all newborns by including it in the National Immunization Programme..

This decision seems to be based on the impression that “hepatitis B is a bigger problem than AIDS†and the news says “Ministry records also say that one in every 20 people in India is a carrier of this deadly virusâ€. As socially concerned experts working in the field of Public Health, and Rational Drug Policy in India, we would like to point out the following –

1) The claim that 4.7% of the Indian population is chronically infected with hep.B virus is gross overestimation based on a paper, which has surprisingly made an elementary arithmetical mistake and also has unscientifically assumed that all those who are found to be positive for hep.B infection are chronic carriers of this infection. Using the same data correctly the actual ‘hep.B carrier rate’ works out to be only 1.42%. (1) The WHO has recommended hep-B vaccination of all newborns only for countries where this carrier rate is more than 2%. (2).

2) Hepatitis B is much more infectious than HIV. However, whereas untreated HIV infection is 100% fatal, in case of Hepatitis B infection only 10% of infected adults become chronic carriers and the average fatality rate due to Hepato Cellular Carcinoma is much lower than what has been claimed (3). About 90% of infected infants become carriers. But carriers eliminate the hep B infection at an annual rate of up to 2% (4) and the overall incidence of the damage due to hep B infection -acute hepatitis, chronic persistent hepatitis (CPH), chronic active hepatitis (CAH), cirrhosis and hepato-cellular carcinoma (HCC) is much less than what is generally believed. (5)

3) Newborns who get hep.B infection at birth from their hepB positive mothers have the highest risk of getting HBeAg infection which the most infectious variety of hep.B infection and which has the highest chances of becoming carriers. (6,7) Prevention of this perinatal (vertical) transmission from hepatitis-B positive mothers requires that newborns at risk be given the first dose of the vaccine within 12 hours of birth. (8) Hence the WHO, the American Academy of Pediatrics have recommended that for such newborns, the first dose of hep.B vaccine must be given not later than 48 hours after birth. In India, since 77% births take place at home, the first dose of hep.B vaccine would not be given immediately after birth but 6 weeks after birth with the first dose of the triple vaccine in the National Programme. Hence in this programme 77% of the newborns will not be protected from the mother- to-child mode of infection, which is the most dangerous type of infection.

4) If we want to take up Hepatitis B vaccination programme at all then the Selective Vaccination Strategy should be used like in other low prevalence countries like Japan, U.K. Netherlands. The Selective Vaccination strategy which consists of identifying the HBsAg positive mothers through antenatal screening and vaccinating their newborns within 24 hours of birth. In India 2-3 % of mothers are hep.B positive, and this selective strategy would protect about 40% of the newborns from the risk of HBeAg positivity by vaccinating only the 3% of the newborns, and this programme would cost one fourth of the Universal Strategy.(9) The cost-efficacy of HB Vaccination should be measured in terms of cost per highly infectious carriers (HBeAg positive) prevented and not HBsAg positive carriers prevented. This is because as mentined above, HBeAg positive carriers are far more dangerous to public health, as they are far more infectious and are far more likely to develop serious chronic liver disease later than mere HBsAg positives. In India, only 65% of women get any health-care during pregnancy. This highly cost-effective selective vaccination programme will not be very effective even for control of Hep. B. infection, (leave aside, it's eradication from India) unless this coverage is substantially improved. Secondly, it will not eradicate hep B infection. But any way even if all newborns are vaccinated in the Universal Vaccination Programme, it will take at least 65 years to eradicate hepatitis-B infection in India.

5) With 25 million babies being born every year in India, even assuming that the cost of hepB vaccine per child in this programme to be only Rs. 50/, (i. e. much less than the current price), it would cost Rs. 125 crores annually for the vaccine alone. This is equal to our budget for TB-control programme (the number one killer of Indian adults) and is almost equal to the combined cost of other 6 vaccines given to infants. The cost-efficacy of this programme is also unfavourable - about Rs. 700 per life year saved (10) compared to around Rs. 20 per life year saved for the measles vaccination. (11)

6) Those medical professionals who come in close contact with blood, patients in need of dialysis/ repeated blood transfusion and persons exposed to unsafe sexual relations should be vaccinated against hep.B on a priority along with newborns of hepatitis positive mothers. Giving this vaccine to all newborns, that too 6 weeks after birth, is neither effective in preventing the most dangerous, mother-to- child transmission nor is it good economics. It will primarily benefit the manufacturers of this vaccine who have succeeded in convincing a section of the medical professionals through their usual techniques.

In view of the very serious, substantial issues mentioned above, we request you to stall your decision to include the hepatitis B vaccination in the National immunization Programme, invite us for a detailed discussion with the concerned officials/experts in your Ministry and initiate a public debate on this issue before taking a final decision.

Sincerely Yours,

1. Abhay Shukla, abhayseema@...

2. Amar Jesan, jesani@...

3. Amita Pitre, cehat@...>

4. Anant Phadke, anant.phadke@...

5. B Subha Srieena , subharakhal@...

6. Chandrima, cehat@...

7. C. Sathyamala, c_sathyamala@...

8. Daisy Dharmaraj, testfoundation@...>

9. Deepti Chirmulay, deeptichirmulay@...>

10. Dhruv Mankad, mankad_nsk@...

11. Manisha Gupte, masum@...>

12. N. Devadasan, deva@...>

13. Narendra Gupta, prayasct@...

14. Nobhojit Roy, nobsroy@...

15. Prabir Chatterjee, prabirkc@...>

16. Rakhal Gaitonde, subharakhal@...

17. Ravi Duggal, cehat@...

18. Ritu Priya, convenor.mfc@...

19. Shashikant Ahankari, hmf@...>

20. Shatrugna Veena, veena52@...>

21. Shyam Ashtekar_nsk" <ashtekar_nsk@...>

22. Sukanya rangamani, sukanyabasker@...>

23. Sunil Kaul, scowl@...>

24. Sunita V B, sunitavb@...>

25. Yogesh Jain, jss_ganiyari@...

cc. The Secretary, Ministry of Health & Family Welfare

References -

1) Phadke Anant, Kale Ashok. HBV r Rate in India. Indian Pediatr 2002; 39: 787.

2) Ghendon Y. WHO Strategy for the global diminution of new cases of hepatitis B. Vaccine 1990;8:S129-133

3) M. Puliyel, Riju Mittal, Vineet Tyagi and Sangeeta Gupta. Routine Hepatitis B Immunization in India : Cost Effectiveness Needs Reassessment. Indian Journal of Pediatrics, Volume 70—February, 2003

4) Mendel, (ed.) Infectious Diseases, 3rd edition 1990, p. 1211, 1215.

5) Lodha Rakesh, Jain Yogesh et al. Hepatitis B in India, A Review of Disease Epidemiology, Indian Pediatrics 2001; 38:349-371.

6) on’s Principles of Internal Medicine, 14th edition, Eds. Fauci, Braunwald, Isslebacher, et al.McGraw-Hill, 1998, P 1679.

7) Diseases of the liver and biliary system. Sheila Sherlock and Doolley, 9th edition, page 308

8) Jordan R, Law M. An appraisal of the efficacy and cost effectiveness of antenatal screening for hepatitis B. J Med Screen 1997;4(3):117-27.

9) Kale Ashok, Phadke Anant. Selective Versus Universal Hepatitis B Vaccination In India. Paediatrics Today, Vol. 4, July 02, pp.199–207.

10) Aggarwal Rakesh A, Uday G, Subhash N. Assessment of cost-effectiveness of universal hepatitis B immunization in a low-income country with intermediate endemicity using a Markov model. J Hepatol; 2003; 38:205-222.

11) Universal Hepatitis–B Vaccination in India – A Questionable Strategy; Anant Phadke, Ashok Kale, R Mansfield (Unpublished paper)

New topic: "Rationale of Hepatitis B vaccination".netrum Date: Thursday, 14 August, 2008, 4:43 PM

Hello NetRUMians,

Here is the third discussion in the series of immunization and rationalism. I take the opportunity to welcome Mr. Rajendra Diwe hard core rationalist for the moderation of discussion "Rationale of Hepatitis B vaccination". Discussion will run from 15th Aug through 19th Aug 2008.

Welcome Rajendraji to the forum as a moderator. Take the charge of NetRUM as per schedule. Regards, Dr. Smita Mali NetRUM Groupie. Send instant messages to your online friends http://uk.messenger.

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Dear Anant Phadke Sir,

Thank You very much for your post. It has really inspired me. In fact I had a hard copy of your article published in isues in medical ethics VIII January-March 2000 titled epidemiology and ethics in hepatitis B vaccine. Attached with this please find one article from V Madhvi regarding the same.

Rajendra Diwe

From: Dr. Smita Mali <smt_mali (DOT) co.in>Subject: New topic: "Rationale of Hepatitis B vaccination" .netrumgroups (DOT) comDate: Thursday, 14 August, 2008, 4:43 PM

Hello NetRUMians,

Here is the third discussion in the series of immunization and rationalism. I take the opportunity to welcome Mr. Rajendra Diwe hard core rationalist for the moderation of discussion "Rationale of Hepatitis B vaccination". Discussion will run from 15th Aug through 19th Aug 2008.

Welcome Rajendraji to the forum as a moderator. Take the charge of NetRUM as per schedule.

Regards, Dr. Smita Mali NetRUM Groupie. Send instant messages to your online friends http://uk.messenger . Send instant messages to your online friends http://uk.messenger.

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Dear All,

Here is yet another article published in 1999

Rajendra Diwe

Vaccination Controversy Takes Center Stage

The issue of mass vaccination programs has been questioned more recently than ever before. In a front page headline article in the August 3rd 1999 USA Today, the issue was brought to the American public stronger than ever. The headline read “Now Parents Fear Shotsâ€, and asks the question, “Are vaccines safe for our kids?†The article points out that children born today in the U.S. will get 21 shots before they reach the first grade.

The article goes on to report that several consumer advocacy groups such as the National Vaccine Information Center, (www.909shot.com ) have raised concerns about data linking childhood shots to diseases such as diabetes, multiple sclerosis, rheumatoid arthritis, asthma, allergies, and death. According to the article, the Vaccine Adverse Event Reporting System received 11,000 complaints about adverse reactions from vaccinations last year alone, with 15% being considered serious. These numbers are sobering considering that many authorities believe that adverse reactions are

extremely underreported.

The article also reported that on July 15th federal health officials suspended the use of the rotavirus vaccine after receiving 15 reports of babies suffering from life-threatening bowel obstruction as a result of the vaccine. Also reported was the fact that only a week earlier the Food and Drug Administration asked vaccine makers to phase out vaccines that contain the preservative thimerosal because of concerns of toxic mercury.

In June, the CDC and the American Academy of Pediatrics began advising doctors to use injected, instead of oral, polio vaccine, because the oral vaccine contains live virus. This resulted in about eight cases of polio a year, which represents the only cases of polio occurring in the USA, all of which were caused by the oral vaccine.

In conjunction with this article, USA Today is conducting a survey on vaccination safety. They have put a survey on the web to judge public opinion on the confidence of the public in the vaccination process. Please take a moment and hit the link below to register your vote www.usatoday.com/life/health/child/lhchi046.htm .

In a related issue, a study was performed and published on the Effects of Diptheria-Tetanus-Pertussis (DTP) or Tetanus Vaccination on Allergies and Respiratory Symptoms Among Children and Adolescents in the United States, by L.Hurwitz D.C., Ph.D. and Hal stern, Ph.D. UCLA School of Public Health and the Los Angeles College of Chiropractic. In this study 13,612 babies and children ages 2-months through 16-years old were studied. Two hundred eighty four (284) children did not receive DTP or tetanus vaccinations. The study results showed, “Subjects who had been vaccinated

were more likely to have histories of asthma, severe allergic reactions, and any allergy or allergic reaction. Vaccinated subjects were also more likely to have had sinusitis or sinus problems, or allergy related nose and eye symptoms in the past year.†The study conclusions were, “DTP or tetanus vaccination in children is associated with a lifetime history and 12-month prevalence of many allergies and related respiratory symptoms. Vaccinations may be partly responsible for the increase of asthma and other allergic hypersensitivity disorders."

Recently the Hepatitis B vaccine has come under extreme criticism. In a recent appearance before the House of Representatives, Committee on Government Reform, Jane Orient, M.D., Executive Director of the Association of American Physicians and Surgeons (AAPS), testified, “For most children, the risk of serious vaccine reaction may be 100 times greater than the risk of hepatitis B.†Adding fuel to this fire the Vaccine Adverse Event Reporting System (VAERS), contains reports of 25,000 hepatitis B vaccine reactions, 8,000 of which involved hospital emergency room visits. VAERS list of side effects and adverse reactions include prolonged screaming, agitation, difficult breathing, visual

disturbances, convulsions, tremors, twitches, spasms, paralysis and more. To this list Dr. Orient adds, “Even more alarming is the huge increase in reports of autism and attention deficit / hyperactivity disorder with devastating life long effects.â€

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Dear All,

Here is something for further reading

Rajendra Diwe

Miracle or Murder?

The Hepatitis B Vaccine Controversy

Few US public health initiative seem as successful as our mandatory vaccination programs. But a growing number of people believe that one vaccine--that for the hepatitis B virus--is both dangerous and largely unnecessary. Emotions run high in a debate that involves pharmaceutical and biotech companies, US health agencies, Congress, and the parents of children now dead or disabled from what they believe is a vaccine about which too little is known.

By B.J. Spalding

About a year ago, Belkin's five-week-old daughter, Lyla Rose, got her third and final shot of the hepatitis B vaccine. She'd never been sick before getting that shot, but she was agitated and fussy at her final feeding that evening,. "And then she fell asleep and didn't wake up," says Belkin, president of Belkin Limited (New York), which provides statistical economic forecasts and financial forecasts to international mutual funds and investment banks.

About five years ago, Bohn Dunbar, who at the time was healthy and athletic, got his first shot of the hepatitis B vaccine. Within 24 hours, he came down with a fever and severe fatigue, symptoms that lasted around a week, and roughly two weeks after that, he developed chronic joint pain and muscle pain, as well as fatigue and symptoms similar to multiple sclerosis. Today, Dunbar is rated permanently and totally impaired at greater than 90%. His health care has already cost Texas--where he got the vaccination--over $500,000 through its worker's compensation program, a figure that will only grow given the severity of his

illness. "His problems have been attributed to the hepatitis B vaccine by over a dozen different specialists of unquestionable medical expertise," states his sister, Bonnie Dunbar, a professor of molecular biology and cell biology in the department of cell biology--the largest such department in the US--at Baylor College of Medicine (Houston, TX).

Indeed, Lyla Rose Belkin's death and Bohn Dunbar's debilitating injuries are just two of the tens of thousands of adverse reactions attributed to the hepatitis B vaccine, which debuted in 1986 as the first recombinant vaccine to reach the US market. The safety of the controversial vaccine--as well as numerous other aspects of its commercialization--has come up at four recent Congressional hearings, though no legislation has yet been drafted regarding the product. Two of the hearings were held by the House subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, which is chaired by

Congressman Mica (R-FL). One of those hearings was devoted solely to investigating reports of hepatitis B vaccine injuries and deaths. The other two hearings were held by the Committee on Government Reform, which is chaired by Congressman Dan Burton (R-IN).

Burton, who has two grandchildren, said at the hearings that his granddaughter was hospitalized within hours of receiving the hepatitis B vaccine, while his grandson became autistic after getting shots of the vaccine. "You can call that a coincidence, but I think it's more," says Burton, adding that "we're going to be beating on this issue as long as I'm chairman of this committee." States Baylor's Dunbar, "Just about every time I talk to someone, they know someone who got sick after getting the vaccine. A lot of times, though, that person just didn't put the two together, the getting sick and the taking of the vaccine."

Developed by Chiron (Emeryville, CA), the hepatitis B vaccine--which racked up over $2 billion in worldwide sales last year--was licensed to Merck (Whitehouse Station, NJ), which subsequently licensed it to Kline Beecham (SKB, Philadelphia, PA). Biogen (Cambridge, MA) also played a role in developing the product and still receives royalties on its sales from both Merck and SKB, as does Chiron.

"One of the main reasons we formed Chiron was to continue development of the hepatitis B vaccine," explains Bill Rutter, chairman emeritus of the firm. Along with his colleagues, Rutter began working on the vaccine in the late 1970s at the University of California at San Francisco. When his team moved to Chiron in 1981, the work continued under contract to Merck, with Chiron responsible for developing the vaccine and Merck responsible for manufacturing and marketing it. "It was beautiful and mysterious and complex. It turned out that in yeast over 100 different peptides self-aggregated to form a true mimic of the hepatitis B surface antigen. It was the first time such a major structure had been formed in such a novel system," exclaims Rutter. "Forming the particle was both a major milestone in molecular biology and vaccinology, as well as one of the major success stories of the 20th century in disease prevention."

Naturally, the merits of any achievement depend on a person's point of view. Says Belkin, "It will only be just when, in their afterlives, all of the people responsible for that vaccine meet my daughter, Lyla Rose. When they meet all those babies whose lives were stolen, who never got a chance."

Therein--in the irreconcilable and unresolvable contentions of the vaccine's detractors and supporters--lies the story of the hepatitis B vaccine, a story of contradiction and conflict, some of which is well-intended and some of which isn't.

Irreconcilable Differences

One contention, one that would seem simple to solve, is the number of people in the US infected with the hepatitis B virus. Generally transmitted through infected body fluids, mainly through infected blood, the virus is most prevalent in such high-risk populations as intravenous drug users and sexually promiscuous adults, and in lower-risk populations such as babies born to virus-infected mothers. Symptoms of the disease include fatigue, fever, and yellowing of the skin. About 95% of patients suffer an acute form of the disease, in which they clear the virus from their blood within six months. Approximately 5% of patients suffer from chronic infections, meaning that they never clear the virus and that they always remain infectious.

Up until the latter half of 1991, the Centers for Disease Control and Prevention (CDC, Atlanta, GA), along with most other medical authorities, stated that the US had one of the lowest rates of hepatitis B in the world, with only 0.1% to 0.5% of the population infected. This compares to countries in the Far East and Africa, where the disease affects 5% to 20% or more of the population.

Indeed, early in 1991, the CDC reported only 18,003 cases of hepatitis B in a total US population of 248 million.

Yet late in 1991, the CDC did an about face. It was then that its Advisory Committee on Immunization Practices (ACIP) recommended that all infants be injected with the first of three doses of hepatitis B vaccine at birth, before being sent home from the hospital. And almost immediately, the CDC generated disease statistics to support this recommendation, stating that the US had an "estimated" 1 million to 1.25 million people with chronic hepatitis B infections and that each year about 4,000 to 5,000 of these people die from chronic liver diseases. It added that from

1980 to 1991, roughly 200,000 to 300,000 new hepatitis B infections occurred annually.

"I guess the drug companies wanted a big increase in US sales of the hepatitis B vaccine, because all of a sudden the CDC started hyping the disease as a huge health threat. And it generated disease statistics, which had no anchor in documented fact, to support this threat," says Barbara Loe Fisher, the president of the National Vaccine Information Center (NVIC, Vienna, VA). Fisher, in fact, has filed a request under the Freedom of Information Act (FOIA) with the CDC, asking the agency to release copies of the "medical and

laboratory criteria used by the CDC to estimate the total number of American adults and children chronically infected with hepatitis B disease."

Furthermore, Belkin, who earns his livelihood working with statistics, states that the CDC is passing off "estimated, hypothetical numbers as actual cases. This is statistical fraud. In the financial world, such misrepresentation would lead to criminal charges. The whole exercise is designed to increase public hysteria about the risk of a low-risk disease, so the CDC can extend its pervasive influence, and so Merck and SKB can increase their annual vaccine revenues."

For its part, the CDC defends its 1991 change of the number of hepatitis B cases in the US. The first set of numbers that it reported--18,003 cases--were "acute, symptomatic" cases of the disease that doctors were seeing and reporting to their state health departments, which then sent these numbers on to the CDC, says Rob Lyerla, an epidemiologist in the agency's hepatitis branch. "But the CDC wanted to get a better idea about what was really happening in the states, because we knew we were just seeing the tip of the iceberg, the numbers for the symptomatic cases."

So the agency came up with the second set of numbers, including the 1 million to 1.25 million chronic cases of the disease. These numbers are actually estimates derived from a blood survey that took place over a four-year cycle and that was made up of hundreds of thousands of tests on blood drawn from randomly selected people who comprised a cross sectional survey of the US population, according to Lyerla. The survey picked up both symptomatic and asymptomatic cases of the disease, both acute and chronic cases. It showed that there had been a vast underreporting of the disease, that doctors had only been reporting acute, symptomatic cases. "So we projected from the survey the number of, not only acute cases of hepatitis B, but acute and chronic cases of hepatitis B that we would expect to find in the entire US. We estimated from the survey, based on statistical

science, the actual number of US disease cases," Lyerla explains.

Both Merck and SKB stand by the CDC estimates. In fact, the CDC estimates have become facts. Somehow, they have evolved into the gold standard, cited unquestioningly by just about every mainstream medical organization on the globe, including the World Health Organization (Geneva), the American Medical Association (Chicago), and the American Academy of Pediatrics (Chicago), to name just a few such organizations. "They're the primary numbers. The CDC only reports primary data," says a Merck spokesperson, Isabelle Claxton. Adds an SKB spokesperson, , "These numbers are the rationale for our vaccinating for hepatitis B. They tell us that hepatitis B is a serious and life-threatening disease."

Is it safe?

Another contention between the victims and the supporters of the hepatitis B vaccine--aside from the true number of virus-infected Americans--is the safety of the vaccine, particularly its safety in babies and children. Following the 1991 ACIP recommendation to begin vaccinating babies for hepatitis B at birth, roughly 40 states mandate that children show proof that they have received three doses of the hepatitis B vaccine before entering daycare or school, with many states beginning the vaccination process near birth. "This, despite the fact that almost nothing is known about the health and integrity of an individual baby's immune system and neurological system at birth," states NVIC's Fisher. Her FOIA to the CDC, in

fact, also requests copies of the "peer-reviewed, scientific studies" used to support the safety of the ACIP's 1991 recommendation.

"I would challenge any clinician or researcher to claim that we have a basic understanding of the human newborn immune system," says Baylor's Dunbar. "It's well-established in studies in animal models that the newborn immune system is very distinct from the adolescent or adult. In view of this lack of scientific and medical information of neonatal immunology, it's remarkable to me that newborn infants are being administered multiple injections of this vaccine, especially since there have been few, if any, clinical trials to adequately evaluate the potential long-term effects of neonatal immunization."

Belkin has generated numbers that support these safety concerns for infants. He states that in 1996 doctors reported only 54 cases of hepatitis B to the CDC in babies between the ages of hours and one year. Yet that same year, the Vaccine Adverse Event Reporting System (VAERS)--a system jointly managed by the CDC and the Food and Drug Administration (FDA, Rockville, MD)--received a total of 1,080 reports of adverse reactions to the hepatitis B vaccine in babies from hours to one-year old, including 47 deaths. Exclaims Belkin, "So total VAERS hepatitis B

reports for the 0 to 1 age group outnumber reported cases of hepatitis B by 20 to 1."

Overall, VAERS has received a total of 17,497 reports of adverse reactions to the hepatitis B vaccine, reactions that occurred after people received the vaccine alone, rather than in combination with other vaccines, during the period between July 1, 1990 and October 21, 1998. Moreover, fully 5,983 of these reports chronicled such serious events as hospitalizations, while 146 of them told of deaths. VAERS, furthermore, is a passive system, not a mandatory one. This suggests that only a fraction of adverse events are actually reported, a fraction estimated by FDA officials to be as low as 1% to 10%.

The CDC puts little stock in VAERS, since "case reports of adverse events following vaccination rarely provide a convincing link between the event and vaccination," claims Harold Margolis, chief of the CDC's hepatitis branch. VAERS case reports of adverse events may be "temporally linked, but causally unrelated. By chance alone, some patients who develop symptoms of illness will do so within several days of receiving a vaccine. Or a vaccine may lead to the earlier recognition of an illness, without increasing the overall risk of that illness occurring," Margolis states.

Interestingly, Merck, like the CDC before it, has come up with its own hepatitis B numbers, though Merck's figures deal with vaccine-related adverse reactions. These numbers, according to spokesperson Claxton, focus on Indiana, the home state of Congressman Burton, who chaired two of the hearings in which the safety and other aspects of the hepatitis B vaccine was raised. "If you immunized all of the people in the three biggest cities in Indiana with our hepatitis B vaccine, only one person would be at risk of suffering an adverse reaction. The risk of a serious adverse event would be

over 1 in 10 million," says Claxton, though she didn't say how Merck generated these numbers.

Baylor's Dunbar, for her part, found the VAERS reports at least partially useful. "What was obvious from the information I obtained from the VAERS reports was that there are thousands of reports listing such conditions as neurological damage, arthritis symptoms, and other serious immunological disorders. These are the same types of medical conditions that, in my extensively detailed investigation of the literature, have been published in dozens of medical journals that cite the correlation of this vaccine and severe immunological reactions."

Dunbar, in fact, has put together a table entitled "Reports of adverse reactions to hepatitis B vaccine" that lists 110 references from medical journals including the New England Journal of Medicine, the Journal of the American Medical Association, and the Archives of Internal Medicine, as well as numerous overseas publications, including the Lancet and the British Journal of Rheumatology. All of these references detail the diagnosis of adverse reactions to the hepatitis B vaccine, including lupus, arthritis, vascular disorders, demyelinating disorders, and chronic fatigue, among other diseases. A minority of these references, however, report on

the original plasma-derived hepatitis B vaccine, which predated the recombinant form of the vaccine. "Patients are reacting to a protein in the vaccine," says Dunbar. "The source of the protein doesn't matter. It's still the same protein, whether it's plasma-derived or recombinant."

Molecular Mimicry: A Possible Culprit

Despite the weight of the evidence to the contrary, supporters of the hepatitis B vaccine deny that it causes any more adverse reactions than expected, as all vaccines cause at least some bad reactions. "No causal link has been scientifically proven between the vaccine and an unexpectedly high number of adverse events," says SKB's . CDC's Margolis states, "Both pre-licensure and post-licensure reviews have shown that the hepatitis B vaccine is among the safest vaccines we have." And Chiron's Rutter adds, "The data show that the benefits of the vaccine far outweigh its risks, if it has any risks at all."

Dunbar, along with other researchers, believes that the risks of the hepatitis B vaccine are great, particularly to specific genetic populations. These researchers postulate that the hepatitis B protein used in the vaccine can cause autoimmune diseases in these subpopulations through several potential mechanisms. One is through a process called molecular mimicry. This process occurs when a person's immune system commits a colossal mistake, confusing a foreign protein for one of the body's own proteins. Consequently, when the immune system attacks the foreign protein, it also attacks its own protein, one of the very proteins that the immune system exists to protect. Such foreign proteins are contained by pathogens like viruses or, more specifically, viral antigens. The hepatitis B vaccine, for its part, is practically an exact replica of a protein antigen on the surface of the hepatitis B virus.

When the body encounters a virus, for instance, certain immune cells literally engulf the virus and chop it up into thousands of protein fragments, known as peptides, each of which is made up of 10 to 15 amino acids. A few of these peptides are carried to the immune-cell surface and placed in a sort of pocket atop what is called a major histocompatability complex (MHC). This signals the immune system to destroy all cells containing

that peptide. Yet the immune system destroys not only virus-infected cells containing the peptide, but also cells in the body that contain similar peptides. "The process can set into motion a cascade of self destruction. And certain people end up developing autoimmune disorders," says Dunbar.

The reason for this is an individual's MHC genes, as well as potentially other genes involved in regulating the immune system. An individual's specific genetic makeup determines which of the thousands of peptides that the immune cell chops the virus into is eventually placed in the pocket of the MHC.

In the case of the association of the hepatitis B vaccine and demyelinating disorders, a number of phenomena appear to occur, Dunbar states. One involves a subpopulation of people, most probably of Caucasian origin, who share similar MHC genes or other genes regulating the immune system. A second involves the MHC genes, which seem to code for the selection of a peptide to be placed in the MHC pocket that is similar in structure to a peptide that is associated with myelin, a substance containing numerous peptides that insulate the nerves of the

central nervous system. The third involves the hepatitis B vaccine, which must contain one or more similar peptides that have similar amino acid sequences or similar structures to the myelin-associated peptides.

"Molecular mimicry can then occur, as has been shown in numerous animal-model studies," states Dunbar. She adds that the National Institutes of Health (Bethesda, MD) has twice refused to fund a research proposal in which she and her colleagues would, among other aims, have attempted to "test our hypothesis that subsets of patients having adverse reactions to the hepatitis B vaccine have similar and predictable MHC gene

sequences."

In near-absolute agreement with Dunbar is Burton Waisbren, a doctor in Milwaukee, WI, who presently is focusing on neurological disorders and who is a founding member of the Infectious Disease Society of America (andria, VA). Says he, "The literally thousands of individuals who've been reported to VAERS and pharmaceutical companies, who claim to have suffered demyelination and autoimmunity from the hepatitis B vaccine, should be followed up to determine their MHC gene sequences to ascertain if host factors are partially causative of the complication." And he

states that the hepatitis B vaccine should be "tested for the extent of its polypeptide homology with human tissue. If significant homology is shown, the offending polypeptides could be removed from the vaccine, or a synthetic vaccine could be produced without them.

Indeed, aside from hotly criticizing the CDC's recommendation to immunize all children with the hepatitis B vaccine, NVIC's Fisher cites a recent NVIC poll of 1,000 registered voters, in which 68% of Americans support a parent's right to choose whether or not their children should receive certain vaccines that could potentially hurt them. States Belkin, "If the hepatitis B vaccine was recommended in 1991 without scientific proof that it was safe in a broad sample of racially and genetically diverse babies less than 48 hours old, then the CDC has been experimenting on babies like guinea pigs, and the universal immunization policy should be suspended."

Both Fisher and Belkin believe that the US should do what France has already done. Late last year, France became the first country to end its hepatitis B vaccination requirements for schoolchildren, after reports of adverse reactions associated with the vaccine simply overwhelmed the country's Health Minister.

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Dear All

Here is an article from Pharma Biz

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

Mass hep-B vaccination shouldnt be allowed

Thursday, January 03, 2002 10:50 IST Joe C Mathew

Hyderabad-based People for Economical and Effective Medicare (PEEM) an eight-year-old, voluntary health promotion trust, aims at providing truthful information about all aspects of various common diseases and effective treatment methods in different systems of medicine. The propagation of preventive healthcare has been one among the priorities of the organisation and it has always been in the limelight for its principled stand against all medications that are excessive and unnecessary. As part of its fight against the increasing commercialisation in the field of medicine, it has been discouraging excessive dependence on drugs, doctors and hospitals. Headed by some of the eminent medical practitioners of the city, PEEM is striving towards making `Health, a People''s Movement''¨. The NGO is among the first of all voluntary groups in the health sector to come out against the

indiscriminate use of Hepatitis B vaccines in the country. As Dr P V R Bhaskar Rao, chairman, PEEM points out, the birth and growth of PEEM has been simultaneous with the indigenous development of recombinant Hepatitis B vaccine and the aggressive marketing campaign, which followed. PEEM began its campaign against mass vaccination of Hepatitis B, as it wanted to expose the commercial interests of the companies involved in spreading a fear psychosis about the dangers of the virus and the resultant campaigns for vaccination by the vaccine manufacturers. Though its vigorous campaign unleashed in Andhra Pradesh against the vaccine seems to have gone unheeded with AP becoming the first state in the country to go ahead with a mass immunisation programme, PEEM is least affected by the turn of events. It is in the process of making the state government realise its `mistake'' and initiate remedial/compensatory actions at the earliest. Dr Bhaskar Rao spoke

more about Hepatitis B and the issues involved in such vaccination to Joe C Mathew of Pharmabiz.com in an exclusive interview. Dr Rao is a well-known cardiothoracic and vascular surgeon and a retired professor of Cardiothoracic surgery. Following are the excerpts:

Why is PEEM totally against the central government plans to include Hepatitis B vaccine under the free Universal Immunization Programme (UIP) during the Tenth Plan even after hepatitis B has been considered by the centre as a "killer disease" which could assume epidemic proportions if not curbed through vaccination?

Presently a scare is spread in our country about the possible dangers involved in being Hepatitis B positive. It is considered as a killer disease and it has been propagated that unless one undergoes vaccination, he/she is likely to die or develop liver cancer. The reason given by the ministers for initiating this vaccination programme is also something similar. They have found that there are 2.5 million carriers of hepatitis B and 6,000 people are dying as a result of this annually in Andhra Pradesh alone.

Let me tell you that mass vaccination against any disease is conducted only when it is capable of developing into epidemic proportions. There has never been any epidemic of Hepatitis B in India. Far from being a killer disease, it recovers spontaneously. To quote Dr Shiela Sherlock, a world famous authority on liver diseases, if 100 people are exposed to Hepatitis B, 95 of them would develop acute infection and 94 recovers spontaneously¨ In less than 1% the disease may prove fatal. Is this a killer disease?

Secondly, no one knows about the incidence of the disease in the country. There are no figures about patients who are diagnosed in the acute stage of infection. Whatever studies done are about the healthy carriers. But these studies about HbsAg, HbeAg and anti Hbe antigen status in the population are done in very small numbers that cannot be generalised. Even such unrepresentative studies show the healthy carrier rate in general population between 1.62 % to 4%. We also know that only 1% among these carriers is likely to be seriously affected by the disease. Is it a killer disease against which mass vaccination is essential?

How do you see the state government supported, Bill Gates-funded initiative of administering free hepatitis B vaccine to 4.5 lakh children in Andhra Pradesh?

It is most unfortunate that AP government is allowing a US-based NGO V PATH, sponsored by the Bill Gates Foundation to experiment on our children and use them as guinea pigs. While countries like USA and France have already suspended their programmes of giving hepatitis B vaccine to all children fearing serious adverse reactions should we allow this experimentation on our children?The AP government shall be held legally responsible for any serious adverse reactions that may occur consequently. It needs only common sense to understand the objectives behind this mass vaccination. Otherwise why should an outright businessman from US develop love towards Andhra Pradesh? Why is the vaccine not procured from the two city-based vaccine manufacturers and instead from a WHO-accepted foreign company?

Let us not go into these questions.

PEEM feels that we should take into account the reported cases of 15 deaths in Assam that happened during UNICEF experimentation with children. The recent clinical trial controversy in Kerala should also be kept in mind while talking about foreign funded campaigns.We would like to inform people that vaccinations are not compulsory and that they have a right to be informed of the side effects of vaccination beforehand. When in America children are not recommended to be vaccinated with Hepatitis B vaccine, why should the American Bill Gates promote vaccination for all children in AP and why should we agree? Obviously there are two standards in every field -- one for US and one for India. PEEM feels that this is another experiment by an American organisation using Indian children as guinea pigs. Let us stop it before an irreversible catastrophe occours.

What are your arguments against the mass vaccination of Hepatitis B?

It is not a killer disease at all. There is plenty of scientific information to support this stand that majority of (more than 90%) of children with acute hepatitis B infection recover completely. The book `Scientific basis and clinical management of viral hepatitis'' edited by Arre Z Zuckermann (page 545) states that fulminant (very severe infection) hepatitis may occour in less than 1% of the affected. A joint statement issued by American Public Health Services (USPHS) and the American Academy of Pediatricians had announced their decision to roll back the recommendation that `all new born infants receive hepatitis B vaccine in year 1997 itself''.

In the same year itself the Communicable Disease Control and Epidemiology of US Federal government had decided to roll back the recommendation to vaccinate all new born infants born to hepatitis B negative mothers. A year after, in 1998, France suspended Hepatitis B vaccination of school children after facing a potential health disaster. It should be noted that France had run mass Hepatitis B immunisation programme for four years before it realised the dangers involved in it.

You can also see that the US Federal government has stated that prophylactic treatment to prevent infection after exposure to Hepatitis B virus should be considered only when there is a prenatal exposure of an infant born to an Hbs Ag positive mother. Expecting the mother to infant route of transmission, all the other routes of transmission of the disease are possible only in adults. As such the disease is an adult disease.

These are certain information provided by international authorities on Hepatitis B vaccination:

l Infections during infancy are estimated to represent only 1-3% of cases (US Department of Public Health ¡V 1996)

l US Federal authorities no longer advocate that all new borns receive hepatitis B vaccine. Unless they are born to infected mothers, infants have virtually no chance to contact the disease (1999)

l Hepatitis B vaccine is given for a disease that a new born or young infant cannot possibly pick up (Pat Griggin Mackie).

l The duration of the protective effect of the vaccine is unknown and the need for booster dose is not yet identified (NVIC-USA and ons'' Principles of Int. Medicine)

l Those who recover completely from Hepatitis B infection acquire life long immunity (¡¦s pathologic Basis of Disease 1994)

l The vaccine is ineffective in infants who acquire the infection in utero and are HbsAg positive at birth (Zuckerman 1993)

l If the person is already a carrier, the vaccine would not help in any way (National Drug Bulletin 2001)

l The genetically engineered vaccine developed in 1987 is so new that little is known about it including whether immunity will last until the babies receiving it reach an age when they might engage in high risk sex or drug abuse. The children are being experimented upon.(Mortality and morbidity weekly report Jan. 1997)

l Children younger than 14 are three times more likely to die or suffer from adverse reactions after receiving Hepatitis B vaccine than to catch the disease (Association of American Physicians and Surgeons 8/7/1999)

To what extent can these warnings considered as serious? Are there any major adverse reactions reported?

There are many side effects of Hepatitis B vaccination. In India there is no follow up of patients after vaccination and hence complications and adverse reactions are not reported. But there are proofs from other countries. For instance, there was a large epidemic of diabetics -- a 60% increase in New Zealand following hepatitis B immunisation programme. Dr Philip Incao, a private physician in a testimony before Ohio House of Representatives Columbus, Ohio, on March 1, 1999 stated that there are many reports in international medical literature even dating as far back as 1987 stating that hepatitis B vaccination is causing chronic autoimmune and neurological diseases in children and adults. On May 18, 1999,

there was a US Senate congressional hearing by its subcommittee on criminal justice regarding hepatitis B vaccine. During the hearing many witnesses complained that following hepatitis B vaccine complications like autis sclerosis, paralysis, arthritis, mental confusion and death have occurred.After reviewing 81 scientific articles, Dr Buston A Waisbren has tabled the neurologic and auto immune disease attributed to hepatitis B vaccination as follows: convulsion, bells palsy, lumbar neuropathy, optic neuritis, transverse myelitis, polyneuropathy, myasthenia gravis, demyelination, multiple sclerosis, guillian-barrie syndrome, encephalitis and uveitis. These are just indicative adverse reactions that have appeared in the international scientific journals.

Do you feel that the Hepatitis B vaccination should be stopped completely?

We would suggest that vaccination should be restricted to persons who need it. It should be understood that Hepatitis B is mainly an adult problem and children should never be vaccinated en masse. We feel that the government should make it mandatory that all pregnant mothers shall be routinely tested for Hbs Ag. This is cheaper and safer than vaccinating indiscriminately all children. The hepatitis B vaccine shall be given to children born to Hbs Ag positive mothers and shall not be given to other children. The vaccines can be purchased from Indian companies, as their products are also equally good when compared to any multinational companies. It is very cheap also.The most important point is to know where not to give the vaccines. It should not be given to infants born to Hbs Ag negative mothers, infants who are HbsAg positive, premature born children, malnourished and

under weight children, anaemic children, children with respiratory infections and children with history of allergies.

The vaccination should not be given without obtaining informed consent from the parent. And India being a country where majority of the citizens comes below the poverty line, one can never think of mass immunizing the children who are not malnourished, not underweight and not anaemic.

Now let us see who should specifically receive the vaccine. According to recommendation of communicable disease control and epidemiology (CDC-USA) vaccinationshould be given in the following situations: a) parenteral exposure of an infant born to Hbs Ag V positive mother, B) inadvertent exposure to HbsAg Vpositive blood, c) sexual exposure to an HbsAg-positive person and d) household exposure of an infant less that 12 months of age to a primary case giver who has acute hepatitis-B.

What should be the government''s role in controlling the spread of the disease?

First of all, it does not have the potential to create the danger that is being projected by the vaccine manufacturers. There could be a possible nexus between these manufacturers and the doctors who advocate their cause. The way some of our doctors are promoting vaccination programmes and the manner in which the companies are sponsoring theseprogrammes and the massive advertisements that appear in print media in the name of organisations and individual physicians certainly point out to a possible unholy relationship between them which cannot be in the interest of medicine or people.

The governments should not be a part to it. The major part of the budget allocations for health should be spent on improving the resistance of people to various diseases through providing shelters, food, clothing and protected water. That would be better than sponsoring immunisation programmes. It will be economical too in the long run.One should always keep in mind that if a child or an adult is vaccinated without an informed consent, the legal responsibility for the adverse reactions lies with the physicians who have vaccinated, as also the promoters whether they are voluntary organisations, drug manufacturers or the government itself

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Dear ALL

This is my last post for today. From the four posts I posted it is clear that there are lot of controversies over the safety and efficacy of Hepatitis B vaccine. Still, in India common people and even scientific community is least bothered about the awareness part of any drug or vaccine which are used most frequently. The discussion is not to harm any one but to spread an awareness and to make the people aware about the other side of coin. Below are some facts and discussions in American assembly. From which it is clear that 0.001% awareness than America is not there in our country.

Thanking You

Rajendra Diwe

HEPATITIS B DISEASE AND VACCINE FACTS

People at high risk for getting hepatitis B disease (which is transmitted by coming into direct contact with an infected person's body fluids) are IV drug users, prostitutes, prisoners, sexually promiscuous persons and babies born to infected mothers. (1)

90-95% of all hepatitis B cases recover completely after 3 to 4 weeks of nausea, fatigue, headache, arthritis, jaundice and tender liver. (2)

Up to 17 percent of all hepatitis B vaccinations are followed by reports of fatigue and weakness, headache, arthritis and fever of more than 100 F.. (3) The vaccine can cause death, according to a 1994 Institute of Medicine report. (4)

According to Merck and Company: "The duration of the protective effect of [the vaccine] in healthy vacinees is unknown at present and the need for booster doses is not yet defined."

In 1996, there were 10,637 cases of hepatitis B reported in the U.S. and the CDC stated that "Hepatitis B continues to decline in most states, primarily because of a decrease in the number of cases among injecting drug users and, to a lesser extent, among both homosexual and heterosexuals of both sexes." (5)

In 1996, 279 cases of hepatitis B disease were reported to have occurred in the U.S. in children under 14 years old. (5)

An historic report in 1994 published by the Institute of Medicine, National Academy of Sciences, reviewed the medical literature for evidence that vaccines, including hepatitis B vaccine, can cause a variety of immune and neurological health problems. An independent committee of physician experts concluded that there were no case controlled observational studies or controlled clinical trials conducted on hepatitis B vaccine either before or after licensure to scientifically evaluate persistent reports that hepatitis B vaccine can cause sudden infant death syndrome; Guillain-Barre syndrome (GBS) and other central demyelinating diseases including transverse myelitis, optic neuritis,

and multiple sclerosis; and immune system dysfunction including chronic arthritis.

The IOM report concluded: "The lack of adequate data regarding many of the adverse events under study was of major concern to the committee...the committee encountered many gaps and limitations in knowledge bearing directly or indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunization, insufficient or inconsistent information from case reports and case series, inadequate size or length of follow-up of many population-based epidemiologic studies...." (5)

There are more than 200 vaccines being created by federal health agencies and drug companies, including Hepatitis C, D and E; Herpes simplex types 1 and 2; gonorrhea; rotavirus (diarrhea); Group A and B streptococcus; meningitis A, B and C; and HIV for AIDS. (6)

(1) CDC Prevention Guidelines: A Guide to Action (1997); (2) on's Principles of Internal Medicine (1994); (3) Merck & Co. Hepatitis B Vaccine product insert (1993); (4) Adverse Events Associated with Childhood Vaccines (1994; (5) Adverse Events Associated with Childhood Vaccines (1994); (6) The Jordan Report (DHHS-1995).

"Protecting the health and informed consent rights of children since 1982."

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

For Immediate ReleaseJanuary 27,1999

HEPATITIS B VACCINE REACTION REPORTS OUTNUMBER REPORTED DISEASE CASES IN CHILDREN ACCORDING TO VACCINE SAFETY GROUP

National Poll Reveals Majority of Americans Want Informed Consent Rights

Washington, D.C. – The National Vaccine Information Center (NVIC) released figures this week which show that the number of hepatitis B vaccine-associated serious adverse event and death reports in American children under the age of 14 outnumber the reported cases of hepatitis B disease in that age group. NVIC is calling the government-mandated hepatitis B vaccination of all children a "dangerous and scientifically unsubstantiated policy." At the same time, a national poll reveals that two thirds of all Americans want the right to make informed, voluntary decisions about vaccination.

Independent analysis of raw computer data generated by the government-operated Vaccine Adverse Event Reporting System (VAERS) confirms that in 1996, there were 872 serious adverse events reported to VAERS in children under 14 years of age who had been injected with hepatitis B vaccine. The children were either taken to a hospital emergency room, had life threatening health problems, were hospitalized or were left disabled following vaccination. 214 of the children had received hepatitis B vaccine alone and the rest had received hepatitis B vaccine in combination with other vaccines. 48 children were reported to have died after they were injected with hepatitis B vaccine in 1996 and 13 of them had received hepatitis B vaccine only before their deaths. By contrast, in 1996 only 279 cases of hepatitis B disease were reported in children under age 14.

1997 hepatitis B disease statistics from eight states reinforce the lack of hepatitis B disease in young children, particularly in children under 5 years old. For children under 5 years old, New Hampshire reported 1 case of hepatitis B; Washington state reported 2 cases; Michigan reported 9 cases; and Texas reported 13 cases. Pennsylvania, Massachusetts, New Jersey and Illinois reported no hepatitis B cases in children under 5 years old.

By contrast, in 1997 there were a total of 106 VAERS reports of hepatitis B vaccine-related serious adverse events and 10 deaths in children under age 5 living in the eight states with 13 of the reported serious adverse events and 2 deaths occurring in children receiving only hepatitis B vaccine.

There were 24,775 hepatitis B vaccine-related adverse events reported to VAERS in all age groups, including 9,673 serious adverse events and 439 deaths between July 1, 1990 and October 31, 1998. Out of this total, 17,497 reports were in individuals who received only hepatitis B vaccine without any other vaccines. 5,983 of the reports were for serious events and there were 146 deaths, which means that 35 percent of reports in all age groups after receipt of hepatitis B vaccine only are for serious events.

During the same time period, there was a total of 2,424 adverse event reports, with 1,209 serious events and 73 deaths in children under age 14 who got hepatitis B vaccine alone without any other vaccines. This means that 52 percent or 1 out of 2 reports for children under age 14, who only receive hepatitis B vaccine, are for serious events.

VAERS depends primarily upon physicians reporting and causation cannot be conclusively determined without in-depth follow-up of each serious event and death report. NVIC maintains that reports made by doctors to VAERS represent only a small fraction of the vaccine-related injuries and deaths which occur in the U.S. every year. A former FDA Commissioner wrote in JAMA in 1993 that one study showed "only about 1 percent of serious events" attributable to drug reactions are reported to the FDA.

A 1994 NVIC survey of 159 doctors’ offices in 7 states revealed that only 28 out of 159 doctors (18%) said they make a report to the government when a child suffers a serious health problem following vaccination. In New York, only one doctor out of 40 surveyed reported vaccine adverse events to the government.

In a related development, NVIC also released the results of a national poll of 1,000 registered voters, taken by The Polling Company on December 8-11, 1998, which showed that 2 out of 3 (68%) Americans support a parent’s right to be informed of the risks of diseases and risks of vaccines and be able to choose whether or not their children receive certain vaccines which could potentially hurt them. A plurality (45%) of

Americans oppose state laws requiring all five-year olds to get the hepatitis B vaccine before being allowed to attend kindergarten and, when given information about risks of hepatitis B vaccination, 59 percent of respondents were less likely to support such mandatory vaccination laws.

Only 25 percent of Americans believe that people, after getting information about risks and benefits of medical procedures such as the administration of prescription drugs and vaccines, should then be required to follow the orders of their doctors or public health officials. The poll’s margin of error is +/-3.1% at the 95% confidence level (i.e. the same survey could be administered to a similar population and yield comparable results in roughly 19 of 20 cases).

Hepatitis B is primarily an adult disease most often transmitted through infected blood. Highest risk populations are IV drug users and people with multiple sex partners. In 1991 the CDC recommended that all infants be injected with the first dose of hepatitis B vaccine at birth before being discharged from the hospital newborn nursery, even though the only newborns at risk for contracting hepatitis B are those born to hepatitis B infected mothers. By 1998, only 15 states required mandatory screening of pregnant women for hepatitis B infection so babies born to infected mothers could be effectively targeted for hepatitis B vaccination, and yet 35 states required all children to get 3 doses of hepatitis B vaccine or be denied entry to daycare, kindergarten, high school or college.

The U.S. has historically had one of the lowest rates of hepatitis B disease in the world even before a hepatitis B vaccine was in use. In 1990, a year before the CDC issued the order for all children to get the vaccine, there were 21,102 cases of hepatitis B reported in the U.S. out of a total US population of 248 million. In 1996, there were 10,637 hepatitis B cases reported. According to the October 31, 1997 Morbidity and Mortality Weekly Report published by the Centers for

Disease Control, "Hepatitis B continues to decline in most states, primarily because of a decrease in the number of cases among injecting drug users and, to a lesser extent, among both homosexuals and heterosexuals of both sexes."

In October 1998, France became the first country to end hepatitis B vaccination requirements for schoolchildren after reports of chronic arthritis, symptoms resembling multiple sclerosis and other serious health problems following hepatitis B vaccination became so numerous that the Health Minister of France suspended the school requirement.

"As more states mandate hepatitis B vaccination, NVIC is getting more reports of children dying or suffering rashes, fevers, seizures, arthritis, diabetes, chronic fatigue and other autoimmune and brain dysfunction following their hepatitis B shots," said NVIC co-founder and president Barbara Loe Fisher. "Newborn babies are dying shortly after their shots and their deaths are being written off as sudden infant death syndrome. Parents should have the right to give their informed consent to vaccination and Congress should give emergency, priority funding to independent scientists, who can take an unbiased look at this vaccine, instead of leaving the search for the truth in the hands of government officials who have already decided to force every child to get the vaccine," she said.

Drug companies marketing the genetically engineered recombinant DNA hepatitis B vaccine in the U.S. used studies to demonstrate safety which only monitored children for 4 or 5 days after vaccination. Professor Bonnie Dunbar, Ph.D., a Texas cell biologist and pioneering vaccine researcher, said "It takes weeks and sometimes months for autoimmune disorders, such as rheumatoid arthritis, to develop following vaccination. No basic science research or controlled, long term studies into the side effects of this vaccine have been conducted in American babies, children or adults." Dr. Dunbar has joined consumers in calling for informed consent to hepatitis B vaccination as well as NIH funding for independent research to determine the

biological mechanism for hepatitis B vaccine reactions, to identify high risk factors and to develop therapies to repair vaccine damage.

Founded in 1982, the National Vaccine Information Center is the oldest and largest vaccine safety and informed consent rights advocacy organization representing health care consumers and the vaccine injured. NVIC was instrumental in the creation of the National Childhood Vaccine Injury Act of 1986, which has paid out nearly $1 billion dollars for vaccine injuries and deaths.

The National Vaccine Information Center is a non-profit educational organization founded by parents of vaccine-injured children in 1982.

"Protecting the health and informed consent rights of children since 1982."

For Immediate ReleaseJuly 8, 1999

VACCINE SAFETY GROUP ENDORSES GOVERNMENT ACTION TO ELIMINATE MERCURY IN CHILDHOOD VACCINES AND ROLL BACK HEPATITIS B VACCINATION FOR MOST NEWBORN INFANTS

Washington, D.C. - The National Vaccine Information Center NVIC), the oldest and largest organization in the U.S. representing vaccine consumers and parents of vaccine injured children, is calling July 7, 1999's joint statement issued by the U.S. Public Health Service (USPHS) and the American Academy of Pediatrics (AAP) to eliminate the mercury content in hepatitis B vaccine and other childhood vaccines and to roll back the universal recommendation that all newborn infants receive hepatitis B vaccine at birth as an important step in improving the safety of childhood vaccines and vaccine policies.

The cumulative effects of ingesting mercury can cause brain damage. Thimerosol, a mercury compound, is used as a preservative in hepatitis B, diphtheria, pertussis and acellular pertussis, tetanus and HIB vaccines. Most infants have received a total of 15 doses of these mercury containing vaccines by age six months.

The surprise announcement late yesterday afternoon came just seven weeks after a May 18 hearing on the safety of hepatitis B vaccine and vaccine policies in the U.S. House subcommittee on Criminal Justice, Drug Policy and Human Resources chaired by Congressman Mica (R-FL). At the May 18 hearing, parents of children, who were injured or died from reactions to the hepatitis B vaccine, as well as scientists critical of hepatitis B vaccine policies, questioned the scientific evidence used to license the vaccine for use in all newborn infants born to hepatitis B negative mothers.

Prior to the hearing, NVIC co-founder and president Barbara Loe Fisher filed Freedom of Information Act requests with both the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) to obtain scientific data used by the FDA to license the hepatitis B vaccine for use in all children and by the CDC to recommend that all newborn infants receive the first dose in the newborn nursery at 12 hours of age.

"Eliminating mercury from childhood vaccines is an important safety initiative and we hope that further evaluation of the cumulative toxic effects of other vaccine ingredients, such as aluminum used as an adjuvant, will also be undertaken in compliance with the FDA Modernization Act of 1997," said Fisher. "Unfortunately, current CDC policies allow doctors to give young infants multiple vaccines simultaneously. There is a real question as to whether current stocks of childhood vaccines containing mercury should be used and whether vaccination of babies under six months of age with multiple vaccines containing mercury should be delayed. However, the CDC's decision, for whatever reason, to roll back the recommendation to vaccinate all newborn infants born to hepatitis B negative mothers and to delay the vaccination of premature or underweight infants is the right thing to do

and will result in the deaths and injury of fewer babies." she said.

Belkin, a New York City father and Wall Street financial advisor, whose newborn daughter, Lyla Rose, died in 1998 following a hepatitis B vaccination, called yesterday's action "a long overdue first step in reforming the unscientific, conflict-ridden bureaucracy that established the infant hepatitis B vaccination policy." Belkin, who is the director of NVIC's Hepatitis B Vaccine Project, told members of the CDC's Advisory Committee on Immunization Practices (ACIP) at a February 1999 meeting that "I hold each one of you who participated in the promulgation or perpetuation of that mandated newborn vaccination policy personally responsible for my daughter's death and the deaths and injuries of all the other beautiful, healthy babies who are victims of the hepatitis B vaccine."

At the May 18 congressional hearing, he criticized the CDC's policy of vaccinating newborn infants born to healthy mothers who are not infected with hepatitis B. The only newborn infants at risk for hepatitis B infection are those born to hepatitis B positive mothers. In a June 1999 hepatitis B study conducted in North Carolina, the hepatitis B seroprevalence rate in new mothers was found to be only 0.2 percent, 25 times less than the 5 per cent seroprevalence rate estimate for the US population used by the Centers for Disease Control to justify universal hepatitis B vaccination.

The National Vaccine Information Center, a non-profit organization founded in 1982 by parents of vaccine injured children, worked with Congress to develop the National Childhood Vaccine Injury Act of 1986 (PL99-660) and played a leading role in obtaining a purified, less toxic pertussis vaccine for American babies, which was licensed by the FDA in 1996. The goal of the organization is to prevent vaccine injuries and deaths through public education. For more information, access www.nvic.org or call 703-938-0342.

The National Vaccine Information Center is a non-profit educational organization founded by parents of vaccine-injured children in 1982.

Children Having Everybody Really Upset Bout Shots:A Vaccination Alternatives Network

Instructions for Hep B Vaccination Legislation

Dear CHERUBS:

This is a call to action. The New Jersey Legislature is planning to pass two Mandatory Hepatitis B Vaccination laws for college and high school age children.

The Senate Bill S-1119 is sponsored by Senator Vitale and the Assembly Version A-1888 by Assemblywoman Weinberg. Both bills can be obtained on the website for the NJ legislature: www.njleg.state.nj.us The next voting Session for the Senate will probably be June 20, 2002 and the next voting session for the Assembly will probably be June 13, 2002.

We need to write our legislators and tell them that we do not want this mandate passed.

You can go to the NJ Legislative Website and poke around till you get to the find your legislator page. If you click on the name of your town the names of your three legislators will come up. Addresses for legislators can be found all over the website. If you do not have access to the web then you can call this number (800)792-8630 and someone from legislative services will give you the same information. You need to write a short letter that:

*States your opposition to Bill A-1888 for your two Assemblymen and Bill S-1119 for your State Senator.

*Give between one and three facts about the Hepatitis Vaccine. (I have enclosed some facts for you to choose from.)

*If you have a personal story about vaccine injury or death, could be about yourself, a relative, neighbor, client, student, etc. please add that at the end.

Please encourage your relatives and friends to write and if you work in a different district than the one you live in please write to both district legislators. A few days later you can call to make sure your letter was received and to ask how your legislator will vote. Thank you!

Hepatitis B Fact Sheet

Hepatitis B is a blood- borne disease, usually transmitted through blood, shared needles and multiple sex partners. Most people are not at risk because the disease is not contagious and only mildly infectious. In 2000, the incidence of Hepatitis B virus in the United States was 2.1 cases per 100,000 with less than 2% of those cases occurring in children. Of these cases, 90% develop antibodies after a flu-like illness, then recover with immunity for life. ["Shots in the Dark," American Spectator Magazine, May 1999 with statistics from the National Centers for Disease Control.] The United States had one of the lowest rates of hepatitis B infection in the world before the

hepatitis B vaccine was introduced. ["Critics say Required Hepatitis B Vaccine not Safe for Everyone," ABC.NEWS.com; and "Hepatitis B Vaccine Reaction Reports Outnumbered Disease Cases in Children According to Vaccine Safety Group," NVIC, 1999.]

The hepatitis B vaccine, Recombivax HB, manufactured by Merck and Co., is a recombinant DNA vaccine. It is produced by cloning hepatitis virus, and then adding the cloned virus to a yeast-based culture. This culture, as with all vaccine cultures, contains a variety of foreign proteins originating from other viruses and bacteria. In 1971, scientists in Geneva discovered that when viral proteins are injected directly into the bloodstream, they combined with human genetic material, causing DNA to mutate. ["Vaccines and Production of Negative Genetic Changes in Humans," Leading Edge Research Group, 1996-1998.

By late 1998, there were 439 deaths in the United States attributed to the hepatitis B vaccine. [Data released in January 1999 by the NVIC from VAERS figures.] Between 1991 and 1999, 25,000 adverse reactions to the hepatitis B Vaccine were reported to the Vaccine Adverse Events Reporting Systems (VAERS

Since it has been shown that less that 10% of doctors report adverse reactions and many vaccine reactions are now diagnosed as SIDS or Shaken Baby Syndrome, there is no accurate accounting of just how many children and adults are suffering an adverse reaction to this vaccine.

By 1999, at least 100 medical reports confirmed at least 45 side effects associated with the hepatitis B vaccine, many related to chronic crippling disabilities and permanent neurological damage. Adverse reactions include: Polyneuropathy, Guillain-Barre (paralytic nerve damage), visual disturbances and blindness, vertigo, tinnitus (ringing in the ears), serum sickness, colitis, autism, herpes zoster, myasthenia gravis and rheumatoid arthritis.

Since 1987, there have been at least 38 reports in international medical literature showing that the hepatitis B vaccine causes chronic autoimmune and neurological disease in both children and adults. ["Hepatitis B The Untold Story": a 16-page report sent to 55,000 pediatricians by the National Vaccine Information Center in 1999.] Because it is genetically engineered, Recombivax HB can confuse the body s immune system into attacking itself resulting in an auto-immune response such as Multiple Sclerosis (MS). ["Ounce of Prevention, Pound of Misery?" Insight Magazine, March 22, 1999] In 1997, while publicly defending the hepatitis

B vaccine, the CDC produced an internal memo suggesting a "possible associations between the vaccine and MS." ["Shots in the Dark," American Spectator Magazine, May 1999]

In 1998, 15,000 people filed a class action lawsuit against the French government because the officially mandated hepatitis B vaccine caused thousands to develop MS-like symptoms. That year, France ended compulsory hepatitis B vaccinations. ["Hep B Vaccine Linked Directly to Autoimmune Rheumatoid Diseases," from Doctors Guide to Medical and Other News, In 1999, Dr. Jane Orient, executive director of the American Association of Physicians and Surgeons (AAPS) made the following statements about the hepatitis B vaccine: "An independent review of the VAERS data; publications by governmental, pro-vaccine, and anti-vaccine groups; and a sample of the medical literatirue leads to the following conclusions: For most

children, the risk of a serious vaccine reaction may be 100 times greater than the risk of hepatitis B VAERS contains 25,000 reports related to hepatitis B vaccine, about one-third of which were serious enough to lead to an emergency room visit, hospitalization, or death." [statement by Dr. Jane Orient, MD, Pres. of AAPS to the Subcommittee on Criminal Justice, Policy, and Human Resources of the Committee on Government Reform, US House of Representatives, June 14, 1999

The AAPS has called for an immediate moratorium on mandatory hep B vaccine for all children pending further research on the dangerous side effects." ["Doctors Call for Hep B Vaccine Moratorium, " US Newswire, July 8, 1999.]

Dear Members of the NJ Senate,

I am writing to ask you to please vote against Bill S-1119 which is a Hepatitis B Vaccine Mandate for college and High School age children. Contrary to all of the scary pronouncements about the dangers of Hepatitis B outlined in the A-1888, Hepatitis B is not a killer infection for most people.

Symptoms of hepatitis B infection include nausea, vomiting, fatigue, low grade fever, pain and swelling joints, headache and cough that may occur one to two weeks before onset of jaundice and enlargement and tenderness of the liver, which can last for three to four weeks. Fatigue can last up to a year. In cases of acute Hepatitis B "most patients do not require hospital care" and "95% of patients have a favorable course and recover completely" with the case-fatality ratio being "very low (approximately 0.1%)". [on's Principles of Internal Medicine (1994)]

The United States had one of the lowest rates of hepatitis B infection in the world before the hepatitis B vaccine was introduced. ["Critics say Required Hepatitis B Vaccine not Safe for Everyone," ABC.NEWS.com; and "Hepatitis B Vaccine Reaction Reports Outnumbered Disease Cases in Children According to Vaccine Safety Group," NVIC, 1999]

By late 1998, there were 439 deaths in the United States attributed to the hepatitis B Vaccine. [Data released in Jan. 1999 by the NVIC from VAERS figures.] Between 1991 and 1999, 25,000 adverse reactions to the hepatitis B Vaccine were reported to the Vaccine Adverse Events Reporting Systems (VAERS). [http://www.vaclib.org/toc.htm#vaers]

In 1998, 15,000 people filed a class action lawsuit against the French Government because the officially mandated hepatitis B vaccine caused thousands to develop MS-like symptoms. That year, France ended compulsory hepatitis B vaccinations. ["Hep B Vaccine Linked Directly to Autoimmune Rheumatoid Diseases," from Doctor's Guide to Medical and Other News, www.pslgroup.com/mednews.htm]

Many Gulf War veterans who had received numerous experimental vaccines fathered "thalidomide" babies after the war. The government tried to say it was some bioterror chemicals sprayed in Iraq. However, some of these babies were born to soldiers who never went overseas. [LIFE, Nov. 1995] Also French soldiers who were never used as guinea pigs for vaccine experiments also did not acquire "Gulf War Syndrome". [www.mercola.com]

My concern about mandating more vaccines is: WHERE ARE THE STUDIES PROVING SAFETY AND EFFICACY ? Children born within the last twelve years are the most highly vaccinated children in history. How do we know they are going to be able to reproduce? If they can, how do we know that they aren't going to be producing a crop of "thalidomide" babies? And why are American legislators so eager to force their own children to be used as medical experiments for untested vaccines BY LAW? There are 300 more vaccines in the developmental pipeline. I hope you can draw the line somewhere.

Sincerely,

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

June 10, 2002

Dear Assembly Speaker Sires,

I am writing on behalf of people I personally know, in this tri-state area, who have become crippled from the Hepatitis B vaccine and families who have had a baby die outright from the Hepatitis B Vaccine. I am asking you to hold Bill A-1888 (S-1119) which is a Hepatitis B Vaccine Mandate for High School and College Age Students for a full Assembly vote this Thursday, June 13 for two reasons:

The first is that as of late 1998, according to VAERS Government Data there were 439 deaths in the United States attributed to the hepatitis B Vaccine. Between 1991 and 1999, 25,000 adverse reactions to the hepatitis B Vaccine were reported to the Vaccine Adverse Events Reporting System (VAERS). [http://www.vaclib.org/toc.htm#vaers].

Hepatitis B is not epidemic in the US and it is not a serious infection. In fact, according to ons Principles of Internal Medicine (1994): "95% of patients have a favorable course and recover completely" with the case-fatality ratio being "very low (approximately 0.1%)." We are obviously forcing a very deadly and defective vaccine on the public by law for a disease that is not only not deadly or crippling, IT IS NOT EPIDEMIC!

The second reason is that since 1947 the right of the Public Health Council to write vaccination regulations appears in the State Sanitary Code 26:1A-7 just preceding the rules regarding the use of privies and cesspools. To my knowledge the New Jersey Legislature has NEVER PASSED A MANDATORY VACCINATION LAW.

The Hepatitis B vaccine mandate for infants in 1999 was the first vaccine mandate to be voted on and passed by the NJ Assembly. However, as it was to be voted on in the full, Senate, I approached then Senate President DiFrancesco with the testimonies I had of New Jersey parents whose babies had either died or become seriously paralyzed from the Hepatitis B vaccine. He immediately and unhesitatingly said to me that the bill was controversial and he would be happy to hold it for a vote. The following year the Health Department wrote the Hepatitis B vaccine mandate into law over the heads of our elected officials. So technically, to date, the blood of these killed and maimed infants is on the hands of the Health Department and not the New Jersey Legislature. If you succeed in passing this bill you will be the first legislator in New Jersey history to be passing these needless death sentences on our children.

Lastly, I would like to point out that it has not always been taboo to criticize Vaccines in the United States. The following is taken from God's Perfect Child, Caroline Fraser, a "1999, pgs. 262-271: The American Medical Association (AMA) was formed in 1847. One of its first goals was to see if it could legislate the new religion of Christian Science (started by Baker Eddy at about the same time) out of existence.

In 1890, the first formulation of the diphtheria antitoxin was introduced. Christian Scientist parents were brought up on charges when their children died, while other bereaved parents were considered blameless. Indeed, the argument that children died under medical care as often as, if not more often than, children under Christian Science care became one of the most effective legal tools in Scientists defense.

In Los Angeles in 1902, Merrill and his wife, both Scientists, were tried for manslaughter after their young daughter died of diphtheria without medical care. Their lawyer argued, among other things, that the diphtheria antitoxin was still considered an experimental, controversial treatment among doctors; that a significant percentage of diphtheria sufferers still died even after receiving the antitoxin; and that the s had believed that their daughters condition was improving shortly before she died. In 1902, the s were acquitted.

By 1910, the legislative crusade of the AMA against Christian Science had markedly failed, just as its former crusade against homeopathy had also failed. Not only did it fail, it inspired Christian Scientists to pressure legislators to pass statutes exempting Christian Scientists from medical licensing requirements, or to revise prohibitive legislation. So, when the medical societies fell back on their first line of defense the prosecution of Christian Scientists for practicing medicine without a license they found themselves stymied.

These aggressive tactics eventually antagonized many fair-minded medical doctors, clergymen and legislators who spoke up for the rights of Scientists. In March 1898, eloquently testified before the Massachusetts legislature against a bill proposing that only physicians and surgeons could be legally licensed to treat sick:

I come to protest against the bill simply as a citizen who cares for sound laws and for the advance of medical knowledge. Were medicine a finished science, with all practitioners in agreement about methods of treatment, a bill to make it penal to treat a patient without having passed an examination would be unobjectionable. But the present condition of medical knowledge is widely different from such a state. Both as to principle and as to practice our knowledge is deplorably imperfect. The whole face of medicine changes unexpectedly from one generation to another in consequence of widening experience, and as we look back with a mixture of amusement and horror at the practice of our grandfathers, so we cannot be sure how large a portion of our present practice will awaken similar feelings in our posterity.

I am here having no axes to grind, except the axe of truth, that "Truth" for which Harvard University of which I am an officer, professes to exist. I am a Doctor of Medicine, and count some of the advocates of this proposed law among my dearest friends, and well do I know how I shall stand in their eyes hereafter for standing to-day in my present position. But I cannot look on passively, and I must urge my point. That point is this: that the Commonwealth of Massachusetts is not a medical body. Has no right to a medical opinion, and should not dare to take sides in a medical controversy. ["Editors Table,"

Christian Science Journal 16, no. 1 (April 1898) pp. 68-69.]

I hope that the "Commonwealth of New Jersey" will follow former Acting Governor DiFrancescos lead in recognizing that it too has no business taking sides in this most serious medical controversy of forcing deadly, untested and unproven vaccinations on our young people by law.

Thank you for taking the time to read this letter. Best Wishes and may God Bless you!

Sincerely,

Barbara FlynnCC: New Jersey Legislature and Hon. T. DiFrancesco

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