The Policy Of Forcing Hepatitis-B And Hib Vaccines On India And Pressure To Eradicate Polio
DR OMESH BHARATI
[Respected Sirs/Madam - I do not agree with all that is said in this article, specially about the need for introducing the Rotavirus & HPV vaccines into India (both are under a cloud for their side effects as well as unethical lobbying), but I do agree that burdening the children with more vaccines in the UIP is not a good idea. I am for improvement in sanitation, hygiene, nutrition, vitamin & mineral therapy (Vit A & C, Zinc) and promotion of breastfeeding (specially colostrum) to curb diseases rather than waste time and money and also risk our children with the unforeseen and life long side effects of vaccines.
Doctors in India have pointed out that polio eradication may be a chimera as unless poverty is eradicated and clean and safe drinking water is provided, the disease will continue to wreak havoc. On top of that the GOI has helped spread the disease with both mOPV and tOPV (undergoing clinical trials in India) which have spread cases of vaccine strain induced polio. The number of vaccine attributed polio victims in India is anywhere between 30,000 to 300,000 according to media reports. The IMA has a figure of 85,000, up to 2005, in its website. Doctors have been "advised" to keep quiet on these issues for "the greater good of humanity".
It is very sad that no effort is being made to track, treat and compensate the unfortunate children. GAVI, UNICEF, Rotary and WHO do not reply to our mails making it plainly evident that they are least bothered about the health of Indian children. Shame upon them who wish to profit by killing and maiming little babies. If the MoH wishes to maintain its credibility it should chastise these institutions which, according to reports appearing in the US media, are today rotten to the core and act as agents for the drug and vaccine industry. All this in line with the objective of achieving a "negative growth in population" that is being openly advocated by both politicians and beaurocrats.
I think we have to call for a boycott of the entire vaccination procedure to make the political mandarins to sit up and take notice. It is a dastardly and heinous act to continue with the vaccination process without making provision for informed consent, introducing a physicians warranty of vaccine safety, compensation in case of adverse effects and without any long term studies on the effects of vaccines, specially when the so called "misinformation" about vaccine dangers circulating amongst dissenters, even within the medical community, is turning out to be a fact rather than rumour. The issue of heavy metals in vaccines is yet to be resolved.
It is very disturbing that poisons are being introduced into infants who are not supposed to be fed anything other than breastmilk during the first six months of their lives. The spread of cancers, diabetes and other immune disorders in children cannot be hidden any longer. Countries putting the maximum emphasis on vaccines have the highest rate of infant mortality. The health of teenagers today is alarming.
We also do not understand how the voices of Indian doctors are not being heard and instead "foreign experts" dictate terms in matters of vaccination policy in India. Who are these "experts" and what influence do they yield to dictate terms? What are these "experts" doing to ensure compensation and treatment for the millions of vaccine damaged children? What are they doing to educate the public about vaccine dangers?
You cannot take the "First do no harm" medical oath and push vaccines at the same time. This is ludicrous. This is madness. This is utter stupidity. - Jagannath]
India is still struggling to immunize itís children against six vaccine preventable diseases and in some states like Bihar and Rajsthan the routine immunization coverage is very low . As low as 8.5 % for measles in district Kishanganj of Bihar and 10.3% in Goda district of Jharkhand and 10.4 % In District East Garo Hills of Meghalya state. Despite the fact that the Measles is still a major killer of children when epidemic struck sporadically throughout the country. Amidst this scenario, the global alliance for vaccines and immunization (GAVI) wants India to adopt the Hepatitis-B and later the Hib Vaccines in Universal immunization schedule (UIP).
GAVI, claims to be working for the benefit of the poor children of the poor nations of the Third World Countries (TWC); and wants to include latest vaccines at ďcheaper ratesĒ in the UIP of TWCs . This is despite the fact that overall immunization coverage is on the decline in India , there is irregular vaccination or no vaccination in most parts of the country. There is decline in production of vaccines upto 99.5 % in case of Tetanus Toxoid (TT) and upto 64% in case of DPT at government run vaccine production center , Kasauli. And new vaccines that are needed in India have not been introduced like that for Cholera, MMR , Rotavirus and HPV for cervical cancer and there is no transfer of technology to produce vaccines for Japanese Encephalitis that killed more than a thousand children few years back and crippled thousands for life. Instead of producing more than required 20 million doses of Japanese encephalitis vaccine the Central Research Institute (CRI, KASAULI) in Himachal is just producing 75,875 doses per annum (2002-2003) and still this fact does not appear to be bothering anybody including GAVI.
The GAVI is purely perusing the agenda of the developed nations with WHO becoming a silent spectator.
The industry in the developed world especially in the U.S. is clear about their commercial motives in the vaccine production. The vaccine industry in the developed world want to recover the money it has spent on the R&D for the vaccines and cost of the vaccine production before it puts itís money on newer vaccine research and production like HIV vaccine development, despite the fact that the present alliance International AIDS Vaccine Initiative (IAVI) spending crores of rupees (even money from India and other TWCs ) would ultimately transfer the technology developed for HIV Vaccine to the Western Industry free, on the promise of cheaper vaccine.
So to help the western industry achieve the goal of recovery of itís money spent on vaccines Hepatitis-b and Hib , the third world countries are being forced to include these vaccines in the Immunization schedules in the name of cheap vaccines to the poor nations. Though everybody knows that no developed country even China is interested in transfer of technology to develop basic vaccines e.g. for Japanese encephalitis or for Cholera and Rotavirus. Every new vaccine is developed in the name of poor but the costs are so high that poor die thinking of their grandchildren would be safe in the days to come. Sometimes vaccine is there, but despite the deaths of millions, it would not be provided if the capacity of the poor nation is not to afford itís costs.
GAVI Wants TWCs to introduce newer vaccines but it is not concerned to help India and other TWCs to achieve 100 % immunization for the six vaccine preventable diseases before it advocates introduction of costly vaccines like Hepatitis-B and Hib, causing a drain on their routine immunization. Despite the fact that the vaccines for these six vaccine preventable diseases are cheap and affordable.
The research in vaccines is another area of concern. Nobody in the World including WHO is seriously thinking of developing vaccines against Malaria or other Tropical Diseases because mostly the developed nations are in Temperate zones . So much so that a proposal to make heat resistant polio vaccine was shot down because it could have benefited the Tropical countries more than the countries in the West. Similarly a proposal to develop Sugar Glass coating for vaccines that would make the vaccines heat stable was not thought to be of any use and was not responded to by the decision makers in the West. WHO could have helped transfer both of these technologies to the TWCs but the opportunity was lost and these useful technologies were lost without putting them into use by the nations who needed these technologies for better vaccine stability.
Everybody knows that it is after much persuasion and assumption of bulk supply orders that the technology to produce polio vaccine was transferred to India in such a way that still we need to import POLIO vaccine from outside countries costing 175 MILLION DOLARS out of which 40 MILLION DOLARS is the LOAN India IS TAKING FROM THE world bank with a RIDER that vaccine would be purchased from the UNICEF though now India has itís own vaccine manufacturing capacity.
More than 500 CRORES are being spent on PULSE POLIO Vaccine out of total annual expenditure of 1004 CRORE RUPEES on polio eradication while routine immunization for the six vaccine preventable diseases is just getting Rs. 327 CRORES ! And T.B. control Rs. 184 crores only.Despite this nobody is being allowed to see the database of AFP cases for research and any further studies including to see the number of VAP cases !
With eradication of polio the U.S. would save 230 million DOLLARS EVERY YEAR and the EUROPE 333 MILLION DOLLARS .
The U.S. recovered the money it donated for small pox eradication within a month of stopping smallpox vaccination in U.S. and the same holds good if polio is eradicated, still now all help for the polio eradication initiative is being withdrawn and India is being asked to bear the burnt of FINAL ERADICATION of itís own and spend funds that India is doing out of Routine Immunization.
Pressure to eradicate the polio is so high that we are being told not to ask about the vaccine induced polio (VAP) cases . Though the sudden and steep rise in number of AFP Cases from 3047 in 1997 to 30,522 cases in 2006 is being attributed to the increased surveillance , the fact is that the vaccine induced polio cases are also a part of it, is not being made public. ALSO THE DECLINE IN IMMUNIZATION IS DUE TO THE FACT THAT THE POLIO VACCINE IS BEEING CONSTRUED BY THE MOTHERS AS COMPLETE VACCINATION.
Also the fact that the field trials for monovalent polio vaccine (MPV) have not been done in India before the introduction of MPV, the vaccine is being widely used. The pressure is so much so that a veiled threat had been issued to impose travel restrictions on Indians traveling to Polio free countries, if the polio is not IMMIDIATLY eradicated.
Despite all this the questions are being raised by many of the desire of the U.S. to keep the POLIO LOCKED in U.S. labs for future use in case of BIOLOGICAL WARFARE.
It is becoming difficult to produce a Cholera vaccine by India because the parameters are being those for the western countries and we need the certification of the west for the quality of our production ? The vaccines produced by the western countries are costly and does not include the Cholera stain that is common in India. So India is striving to have a Cholera vaccine that is 100% effective and is not putting to use a Cholera vaccine that is 70 % effective despite the fact that this 70 % effective vaccine only can save more then half a million deaths in India and other developing countries. This need to be understood clearly in the light of the fact that at present India donít have any vaccine to protect against Cholera and at the same time no vaccine produced elsewhere is licensed in India. So keeping in view the number of lives saved, India should put to use the heat killed Cholera vaccine even if it is 70 % effective and sidewise can keep on developing better options and adding new strains to this vaccine. Vietnam has already done this by producing cheap heat resistant cholera vaccine. Otherwise it may take 30 more years for India to develop the vaccine up to 100 % western acceptance ,killing millions till that time !
While India is struggling to develop vaccines against Malaria, Rotavirus, Human papilloma virus, Japanese encephalitis and cheaper Rabies vaccine; no serious help is coming from GAVI, WHO and other partners though India have been forced to be an alliance partner in developing HIV vaccine in International AIDS VACCINE Initiative (IAVI) and spending Millions on HIV Vaccine despite the fact that our public health priorities are Malaria, T.B., Rotavirus, J.E. and cervical cancer.
For this India needs to pick-up the vaccine development projects that have been abandoned by the west due to their cost- benefit ratio or for the fact that they are more useful to the Third world countries than the west. These abandoned projects can be transferred after paying the minimum fee and developed in India like SUGARGLASS technology for the heat resistant vaccines and development of VCCINE VIAL MONITORS (VVM) TECHOLOGY FOR DIFERENT HEAT LABILE VACCINES. Because, in the west, the vaccine production is a side business to production of other drugs and also the pressure of the shareholders is there for more and more profit . Indian public sector can take up the production of these vaccines at priority in the interest of the poor patients and be more competitive in understanding the concept of taking vaccines from the LAB to PRODUCTION. The vaccine producing institutes like CRI, Kasauli and NIV,Pune need to be made accountable autonomous bodies with clear mandate and sufficient R&D infrastructure . Also INDIA AND CHINA and other developing countries need to develop more co-operation in developing vaccines than India depending on western countries as the interests of both are different.
Regarding compulsory licensing of the drugs and vaccines we should develop capacities so that if the provisions of compulsory licensing (CL) are invoked in emergencies, we are in a position to develop the drug or vaccine in a shortest period possible. For example during the Bird-flue pandemic we should have assertively invoked the provisions of CL and forced the Roche to immediately part with the technology for the drug Tamiflue, but the fact that the company kept on dragging itís feet at the cost of an impeding epidemic need to be curved in future. Also the Animal Disease Lab in Bhopal that have made the bird-flue vaccine for the birds, need to be developed further for human trials and development. We should learn lessons from Thailand where compulsory licensing has recently been introduced for latest anti HIV drugs evoking strong protest by the companies involved in their production originally.
The last thing the government needs is to contain the MISINFORMATION OR NON-INFORMATION campaign by these vaccine manufacturers in India and TWCs. For example take the case of Anti-Rabies Vaccine (ARV) , the INTRA-DERMAL option is still not being made available THOUGH IT WOULD COST ONE FIFTH OF THE INTRA-MUSCULAR OPTION, and despite the fact that the same is being used in a nearby country Thailand for many years of now. And nobody including WHO or GAVI is bothered to force this intra-dermal option of cheap vaccine onto the multinational companies. When pressure from the NGOs mounted then the vaccine producers said that for INTRA-DERMAL OPTION it needed to be field tested before putting it into use. Can these producers tell that did they tried and field tested the ARV in India before itís marketing here ? Did they do the field trials for Hib Vaccine before it was marketed and put to use in India or for that matter for MONOVALENT POLIO VACINE BEFORE it was imposed on Indian KIDS ?
ALL ARE DELAYING TACTICS. Even when it was proved that the ARV vaccine is rather more effective intra-dermally than intramuscularly, these companies are questioning the competencies of our health workers to administer ARV intra-dermally ,though they are doing it in case of BCG since for many years now. As regards to Hepatitis-b, a misinformation campaign is on that it is more dangerous than HIV. The campaign is going on despite the fact that the chances of a villager to get hepatitis-b are for more less than getting tuberculosis or malaria in India.
Regarding the COST-EFFECTIVE ANALYSIS OF HEPATITIS-B in India for UIP BY AGGARWAL et all (2003); THEIR ASSUMPTION THAT the cost of a single dose of hepatitis-b vaccine being approximately Rs. 20/-(1.5 $ for three doses) and DPT coverage in India assumed to be as 75 % ,to calculate the cost ,is a gross underestimation of the facts and reality both in terms of actual price and the actual coverage for DPT. According to NFHS-III (2006) The DPT-III COVERAGE IN INDIA IS ONLY 55.3%.
The Director General of ICMR , DR. N.K.GANGULI puts this in the right perspective saying that ďAT THE MOMENT TWO DOSES OF HAV vaccine cost enormously high because the vaccine in India comes from an international source and GlaxoSmith-Kline (GSK) WHICH MADE PROFIT IN HEPATITIS-B VACCINE ADDED HEPATITIS-A TO HEPATITIS-B ;The cost of this is very high at this moment, although the recombinant Hepatitis-b which we make by the bucketful has crashed to Rs. 20/- or so.Ē
So, we need to understand this business of charity in Vaccines and need to develop our own strategy to combat diseases in India than IMPORT THE DISEASES FIRST AND THEN THE VACCINES FROM WESTERN COUNTRIES AS IS THE CASE WITH HIV !
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BY DR. OMESH BHARTI FOR HIMACHAL CONSUMER PROTECTION FOURUM, AND JAN SWASTHYA ABHIYAN.