The Hep-B Vaccine: How dissenting voices were scuttled

The Hep-B Vaccine: How dissenting voices were scuttled by Jagannath Chatterjee

The Hepatitis B vaccine is being offered as a lifesaver today, "a birth right of children". Very few people know the antecedents of this vaccine and how it was opposed by doctors worldwide. Hep-B is a sexually transmitted disease and the vaccine was originaly intended for the gay population, promiscuous heterosexuals and the sex workers in the USA. They refused the vaccine as there was news that it was contaminated with HIV. But the vaccine had to be marketed and the manufacturer then directed it to unsuspecting consumers in the developing countries. The doctors in these countries could see through the ruse and many objected vehemently. Researchers wrote against it in medical journals. Doctors refused to ptrescribe the vaccine and the marketers started holding vaccination camps through NGOs and other institutions. But the real game was played in political and beaurocratic circles and the vaccine was approved for use in certain states in the Universal Immunisation Program. In Orissa the vaccine was imposed on tribals. The original dissenters were silenced with threats and their statements were pulled out of the internet where they were published alongside print editions. I will present before you one such article on Dr Bhaskar Rao, eminent cardio vascular surgeon, who was one of the first to object.The link does not work anymore. But a very short version is still in the Hindu website.

The Hindu Link

A portion of the article by medical scientist Dr Y Madhavi is available here;

As of today peer reviewed published articles in medical journals have connected the Hep-B Vaccine with 65 serious chronic illnesses.

Article in Pharmabiz (pulled out subsequently)

Mass hep-B vaccination shouldnt be allowed 

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

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.

- Dr Bhaskar Rao, Cardiothoracic & Vascular Surgeon.

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 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 Harrisons'' Principles of Int. Medicine)l Those who recover completely from Hepatitis B infection acquire life long immunity (Robinson¡¦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 theneurologic 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 consentfrom 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.