More Than A Pinprick
THE RISK TO INDIA’S NEWBORNS
A SLY FUDGING OF FACTS IS PUSHING INDIA INTO BUYING VACCINES BACKED BY THE WHO THAT MAY HAVE KILLED CHILDREN IN OTHER COUNTRIES
BY VIJAY SIMHA
BABIES, THEY say, are a nice way to start people. They are also, it would appear, a nice way to start profit. If the babies are Indian, there’s added allure to the profit because there are so many of them every year. In the days to come, as the denouement of a series of extraordinary events, the Indian government is expected to make a fresh decision on the number of vaccines Indian infants are to be given soon after birth. Much rests on the decision for Indian families and, oddly, the World Health Organisation (WHO), which has made a bizarre push for new vaccines it wants Indian newborns to be given in the country’s public health programme.
| The government procures the trivalent vaccine at Rs 15 from Indian firms. The WHObacked vaccine costs Rs 525 |
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| Unsafe shield? Health Minister Ghulam Nabi Azad being injected with the H1N1 flu vaccine; a child waiting for a shot Photo : NAVEESH TEJPAL |
The Vaccines
India does not have a well-defined vaccine policy. It has a National Immunisation Programme, under which it conducts an Expanded Programme of Immunisation (EPI). Twenty-five million children are born every year in India. That is a vast vaccine market, far bigger than many countries put together. Only about 53 percent of the children born in India are vaccinated. This means about 11 million children in India, almost wholly from poor families in the hinterlands, still need to be vaccinated every year.
| WHAT THEY SAY - The deaths in Bhutan, and Sri Lanka were not related to the pentavalent vaccine |
India’s EPI covers six primary vaccines: BCG, Bacillus Calmette-Guérin, a vaccine for tuberculosis; DPT, also called the trivalent vaccine, for diphtheria, pertussis (whooping cough) and tetanus; DT, a diphtheria and tetanus vaccine given to children with adverse reactions to pertussis or where there is a family history of seizures or brain disease; TT, tetanus vaccine normally given as DPT or also separately; measles; and polio.
| WHAT IT MAY IMPLY - The new probe parameters are designed to hide the probable adverse effects of vaccines |
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| Photo: REUTERS |
The WHO is entering this landscape and is pushing for an expansion of the trivalent DPT vaccine into a pentavalent vaccine by including two other diseases, hepatitis B and Hib, based on motives and theories that are being questioned. Switching to pentavalent would force India to shut its public sector units and depend entirely on the pricing whims of the private sector.
The Cost
The WHO push for a pentavalent vaccine in India’s public health policy is based on two arguments: that Hib and hepatitis B exist in India to an extent enough for public vaccination, and that the pentavalent vaccine works in other countries, notably Asian nations like Sri Lanka and Bhutan, in the same geographic zone as India.
This is being seen by Indian experts as an attempt to market vaccines manufactured by big pharmaceutical companies like GlaxoSmithKline Pharmaceuticals Limited, by creating a fake scare of hepatitis B and Hib in India. There is a huge cost factor to this. The WHO is seeking an amendment in our public health policy on immunisation. This means the government will have to pay for the pentavalent vaccine when it has no money.
| WHAT THEY SAY - The Hib vaccine is part of national immunisation programmes in over 140 countries |
Appallingly, there is no concern for the 11 million or so Indian children who are not vaccinated because they are too poor to afford private care, and because the government has not yet established systems to reach them. So, while a massive number of children are already suffering, the push for a pentavalent vaccine only increases costs of existing vaccines.
| WHAT IT MAY IMPLY - India is being peer-pressured into spending on unnecessary and possibly fatal vaccines |
Singh says India’s trivalent vaccine is failing because of several reasons that need urgent attention. “Vaccines need to be maintained at a specific temperature. They go from a pharma company to the government of India, which then sends them to state governments. From here, the vaccines are sent to district centres and from there to primary health centres and anganwadi workers who carry them to homes. We do not have a cold chain system that can keep the vaccines at the temperature they need. So the vaccines fail. This is a top priority area. Then, we don’t have enough doctors, nurses and other workers. Those we have are not trained well. This is a disaster that needs immediate investment of money and skills,” says Singh.
Somebody needs to make the pentavalent vaccine on a scale that India needs, should the WHO convince the Union government to go for it. The Indian firms that make the trivalent vaccines have only recently reopened under pressure from a group of concerned experts after they were shut by the first government of the United Progressive Alliance (UPA). Now, the WHO wants hepatitis B and Hib vaccines added, which these Indian firms have no expertise at making. This is where the friends of the WHO, organisations and companies based largely in the US, come in. It is most likely that the pentavalent vaccine will then come from agencies and companies outside India. This is worrisome.
The Deaths
The economic burden of a pentavalent vaccine is a bother, but less so when seen in the light of what happened in Sri Lanka and Bhutan, where the WHO got the governments to use a pentavalent vaccine. In Bhutan, the government stopped the use of the pentavalent vaccine just two months after it was introduced. In late October 2009, the Bhutan health ministry sent an urgent circular to various centres and clinics saying: “The use of pentavalent vaccine should be stopped immediately due to some side effects. All adverse events following immunisation (AEFI) must be reported and investigated.”
| POLIO PARALYSIS | |||
| The Trouble With The Polio Vaccine More cases are being reported from Bihar and Uttar Pradesh despite increased doses
The AFP rate is the number of persons paralysed per 100,000 population. Ordinarily, it is expected to be one or two per 100,000. But, the official figures of the National Polio Surveillance Project (NPSP), a joint effort of the union government and the WHO, show that the number of AFP cases by the first week of June 2009 were 4,280 in Bihar. This year, the figure has gone up to 5,190, which is a 21.26 percent increase. In Uttar Pradesh, the AFP cases have gone up from 5,286 in June 2009 to 6,824 in June this year. This represents a 22.54 percent increase. Almost all cases of AFP are seen as polio. “When we refer to AFP, we take it polio although not all AFP cases are caused by the polio virus. But a majority would be,” says Dr Sanjeev Singh, an advisor to many hospitals in Delhi. Singh says he can barely recall two cases of non-polio AFP over several years of work.
Another reason given for the increase in polio cases even after a massive Pulse Polio Immunisation programme is that there is better surveillance now, people are more aware, and they are therefore reporting more cases now. If that were so, there is all the possibility of far more polio cases being discovered. This, in turn, raises doubts over the efficacy of the polio vaccine. In 2007, TEHELKA reported that a new polio vaccine was introduced without informing the public and the the AFP rate in Uttar Pradesh rose from 3,789 in 2004 to 10,055 in 2005, when six doses of oral polio vaccine were given, and to 11,538 in 2006 when a further nine doses were administered. In 2006, the AFP rate in Uttar Pradesh was 16.87 per 100,000. Today, it is 22. In Bihar it is 32. So, is the repeated vaccination in these states, which are receiving more doses, responsible? AFP is no mild disease. About half the cases are permanently paralysed, says an analysis in the journal Indian Pediatrics. It appears that the polio vaccine is another example of the government ceding to international agencies, who are pushing for more doses. |
| WHAT THEY SAY - We, the Global Alliance for Vaccine Initiative, will pay Rs 145 of the Rs 525 cost of the vaccine |
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| Beginnings A health worker gives polio drops to a child in Allahabad (above); A baby gets his shots in an Indore hospital Photo: KAILASH MITTAL |
| WHAT IT MAY IMPLY - India will have to pay Rs 380 anyway. And when the subsidy ends in 5 years, it’ll pay Rs 525 |
When a vaccine goes wrong, the WHO has an Adverse Events Following Immunisation (AEFI) Causality Assessment. This is the crucial document that explains the link between a vaccine and adverse events after it is administered. The WHO AEFI assessment has six categories: very likely or certain (that the deaths happened because of the vaccine), probable, possible, unlikely, unrelated, and unclassifiable.
In simple terms, ‘very likely or certain’ means an adverse event must follow the vaccine within reasonable time, there must be no other explanation like a concurrent drug or chemical or disease, and, the adverse event must be proved definitely using a re-challenge, meaning the process of vaccination is repeated again. In cases of deaths like in Sri Lanka and Bhutan, a re-challenge is impossible. So, it becomes easier to blame the death on other factors.
‘Probable or likely’ means an adverse event must follow the vaccine within reasonable time, there must be no other explanation for the event like a concurrent drug, chemical or disease, and re-challenge information is not required. A ‘possible’ situation is where an event must follow the vaccine within reasonable time, and may also be explained by a concurrent drug, chemical or disease. ‘Unlikely’ is where there is the time after a vaccine is given may make an event improbable, and another drug, chemical, or disease provides plausible explanation. ‘Unrelated’ is where the time between an event and a vaccine administration makes the link incompatible, and where another drug, chemical or disease explains the event. ‘Unclassifiable’ is where too little is known.
| Five children died in Sri Lanka in 2008, and eight in Bhutan in 2009 after the pentavalent vaccine was administered |
Now, with the removal of these two categories, all deaths become unlikely (due to a vaccine) because that is the next classification available. The WHO panel thus reported that three deaths in Sri Lanka were unlikely to have been caused by the pentavalent vaccine, one was unrelated and one was unclassifiable.
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| Mothers’ day out Women wait with infants at a Kanpur government health clinic for early vaccinations photo:GP AWASTHI |
When asked why the parameters were altered, WHO Group Leader for Global Vaccine Safety, Patrick Zuber, told TEHELKA: “WHO provides a guideline for a six-point classification of the potential causal association between an AEFI and vaccination but it is important to note that this classification is not intended to be used on its own. Case classification is the result of a full evaluation of all clinical and epidemiological data available. WHO’s proposed system is not the only one available as a number of regulatory and safety expert groups use other scales for the assessment and classification of cases with regard to the potential causal link between AEFI and vaccines.
Benefiting from the experience of its members in the field of causality assessment, the panel proposed to simplify the categories of causality in the current assessment based on all these factors and provided its definitions in the report. In this particular instance, of the 13 cases reviewed (deaths and non-death complications), four were classified as unlikely related to the vaccine and five were considered unrelated. Four could not be classified because of insufficient information. Clearly, none would have been considered as probable or possible associations. More importantly, this investigation did not yield any new evidence suggesting that an unusual safety problem could have occurred in relationship with the use of pentavalent vaccine. Since then, Sri Lanka has resumed use of the product with no new safety signal to our knowledge.”
Now, no other cause of death has been established in the Sri Lanka cases. So, listing them as unrelated is not justified. In the earlier WHO classification, they would have been listed as likely to have been related to the vaccine and that would have led to a fresh review. Now, none of that is possible and this in turn makes it easier for the WHO to push vaccines into India.
The Fudge
To make a pitch for the pentavalent vaccine in India, the WHO needed to establish the prevalence of hepatitis B and Hib to the extent needed for public immunisation. It was bafflingly done. In 2000, an article appeared in a journal called Health Economics, written by Mark Miller from Atlanta, USA. The article said 250,000 people die in India every year of liver cancer caused by hepatitis B. This figure was astonishingly arrived at by using data from Taiwan on India.
The article said one in four carriers of hepatitis B dies of liver cancer in Taiwan. However, the strain of the hepatitis B virus in Taiwan is different from that in India. Also, data from the Indian Council of Medical Research (ICMR) suggests the strain of hepatitis B in India causes liver cancer in only one out of 100 carriers of hepatitis B. This means the death rate in India of liver cancer due to hepatitis B is 10,000 a year. This is a minor percentage of the nearly 25 million deaths in India every year, of many reasons. It is too low to warrant public hepatitis B immunisation and may have led the WHO into exaggerating the figure 25 times.
A paediatrician from Delhi’s St. Stephens Hospital, Jacob Puliyel, challenged Miller’s theory. Miller couldn’t prove what he wrote and finally said the model on which he based his findings was lost. Strangely, the WHO reasoning for a hepatitis B vaccine in India is similar to that in Miller’s article. “He was using a fake model,” Puliyel said.
The WHO argument for a Hib vaccine is based on a 2006 UNICEF report, Pneumonia: The forgotten killer of children, which said 14 out of every 1,000 children in India under the age of five die of pneumonia. However, an ICMR study in 2005 showed the death rate was just 0.26 per thousand in India. The ICMR study was done in three centres, Chennai, Ahmedabad, and Chandigarh. It found that all cases of pneumonia were just 30 per thousand and that of meningitis were 20 per thousand. Hib is the principal cause of pneumonia and meningitis, therefore the focus on these two diseases.
Even if there were a 10 percent mortality rate in pneumonia cases, it would still be only three deaths per thousand from pneumonia. This is 50 times lower than the UNICEF figure and, again, far too low for public immunisation. Thus, there is something seriously amiss about the argument for a pentavalent vaccine, especially when it might lead to death. In any case, the vaccine’s efficacy is not established beyond doubt.
Where it Stands
The ICMR is expected to take a decision on the pentavalent vaccine soon. It has held three meetings on this. There is a National Technical Advisory Group on Immunisation (NTAGI), which is responsible for advising the government. The ICMR formulates research based on this advice.
Fighting against the move to introduce controversial vaccines is a group of experts. They include: KB Saxena, former Union health secretary; SK Mittal, former head of paediatrics, Maulana Azad Medical College, New Delhi; Debabar Banerji, Professor Emeritus, Centre of Social Medicine and Community Health, Jawaharlal Nehru University; Imrana Qadeer, member, Population Council; NJ Kurian, former advisor, Union Ministry of Finance; Ritu Priya, advisor, National Rural Health Mission; Mira Shiva, member, Central Social Welfare Board; Jacob Puliyel, head, Paediatrics Department, St Stephens Hospital, Delhi; and Gopal Dabade, president, Drug Action Forum, Karnataka.
In July, the ICMR will formally advise the health ministry on the pentavalent vaccine. Trust they will choose life over profit.
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