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 | The Times of India -Breaking news, views. reviews, cricket from across India | | | | |  | | WHO for cheaper, effective drugs8 Sep 2008, 2121 hrs IST, Rema Nagarajan |
| If a disease can be treated for Rs 10 why would you spend Rs 12,000 for it? Especially in a country short on resources and even shorter on implementation of health programmes? That is the question being raised by
some doctors on a move to make a vaccine against pneumonia part of the immunisation programme in India.
Pneumonia is said to be the cause of death of almost one in every five children in the under-five age group. That, the proponents of the penumococcal vaccine, mainly the WHO, say is good enough reason for the vaccine to be made a part of the programme.. Prima facie, the argument sounds good.
According to the WHO protocol, pneumonia in children is to be treated with co-trimoxozole (commonly known as Septran), an antibiotic that costs just Rs 10 for the treatment of a child. On the other hand, the vaccine is prohibitively expensive -- Rs 12,000 for a course of three injections for a child. Besides, the vaccine is not a fail-safe prevention – according to studies, it creates immunization against pneumonia in just four out of a 1000.
On September 1, the WHO Bulletin published a letter casting serious doubts regarding the use of the new pneumococcal vaccine. The letter points out that an analysis of all studies on the vaccine shows that the vaccine does not reduce the incidence of clinical pneumonia. The letter further pointed out that analysis had also shown that the vaccine only reduced the chance of 'radiological pneumonia' and not of 'clinical pneumonia.
Those arguing against the vaccine being made part of the immunization programme have a simple argument. Where the cause of the infection is bacterial, Septran will do the trick in most cases. Where it is not, the vaccine will not work either. In fact, they argue that even getting an X-ray done is a luxury for most. Treatment with antibiotics on the basis of clinical symptoms is a far less expensive option. It would mean that in some cases antibiotics will be prescribed where they serve no purpose – the viral infections – but no harm would be done and considerable expense saved, an important consideration in countries where most patients are poor.
In its reply, the WHO defends the vaccine, but admits it does not reduce clinical pneumonia. The reply admits that only 3.6 cases of pneumonia (radiological pneumonia) are prevented for every 1000 children immunized. "If the four (3.6) children could be saved by treating them with Septran, which would cost Rs 40, why would a cash strapped country like India opt to vaccinate the 1000 children, which would cost Rs 1.2 crore?" asks Dr Jacob Puliyel, one of the authors of the letter published in the WHO Bulletin and senior paediatrician in St Stephens Hospital, Delhi.
"Of course, the WHO has an 'introductory offer' for the vaccine by which countries can get 3 doses of the vaccine for about Rs 50 per child. The cost will then be Rs 50,000 to vaccinate 1000 children," points out Dr Puliyel. Yet, that would mean Rs 50,000 to be spent to save Rs 40.
Radiological pneumonia, against which the vaccine is effective, is relatively rare. Even the effect on radiological pneumonia, the letter pointed out, was seen only in children less than 2 years of age, after which vaccination had no benefit.
What is the difference between clinical pneumonia and radiological pneumonia? In general, a child with cough and difficulty in breathing is suffering from pneumonia according to the WHO definition. The cause may include infection by bacteria and virus as well as other reasons of difficult breathing.
Radiological pneumonia is pneumonia which is confirmed by x-ray and caused by bacteria. Common bacteria that cause pneumonia include pneumococcus and hemophilus influenzaie. Vaccination against hemophilus influenza and pneumococcus will prevent pneumonia caused by these bacteria, but will no prevent clinical pneumonia due to other causes.
In a report on pneumonia from Pakistan published in the British Medical Journal in September 2006, radiological pneumonia was present only in 14% of patients with clinical pneumonia. The pattern in India is unlikely to be very different. Therefore it is clear that most cases of pneumonia cannot be prevented by the vaccine.
Moreover, one of the side effects of the vaccine is supposed to be the chance of a child developing asthma. The study quoted by WHO to bolster its recommendation for adding the pneumococcal vaccine to the immunisation programme states that the chance of increase in asthma is 1.3 cases per 1000 vaccinated. "In simpler terms, one child in 1000 vaccinated could develop asthma because of the vaccine. This child may need lifelong treatment with inhaled asthma drugs and steroids. Pneumonia is a disease that can be treated and cured with antibiotics but asthma is often a life long disability treated with inhaled bronco-dilator drugs and steroids," explains Dr Puliyel.
This vaccine that is being recommended is a seven-valent vaccine – covering seven different strains – that is said to cover over 40% of the strains of pneumococcal bacteria causing pneumonia in India. In April this year, a high-level expert committee headed by department of biotechnology (DBT) secretary Dr M K Bhan, had recommended the use of the pneumococcal conjugate vaccine (PCV) in the country's routine immunisation (RI) programme. The committee's major recommendation, however, was that the vaccine used in India would have to cover at least 70% of the sero types (strains) circulating in the country.
A senior paediatrician pointed out that even a nine-valent vaccine would only cover 60-70% strains in our country. He further pointed out: "The decision to introduce a vaccine into your immunisation programme or not depends on your priority and budget. Only a tenth of the total pneumonia is caused by pneumococcal bacteria. If you have tackled all other urgent health problems and you wanted to reduce pneumococcal pneumonia through vaccine, it would have been all right. But as of today, it is not cost effective for our country."
However, about the side effect of asthma due to the vaccine, the senior paediatrician felt that the study was not specific whether the increase in cases of asthma was only due to the vaccine. "There could be many causes for increase in asthma. You need more specific data to get seriously worried about this side effect," he added.
The health ministry itself had stated that it planned to start introducing the vaccine in states with high RI coverage and good RI infrastructure as the PCV was "highly expensive and also required good cold storage chain network. With even the best states like Tamil Nadu and Kerala never managing more than 81% or 75% RI coverage, it seems surprising that the health ministry is more interested in introducing more vaccines into the immunisation programme rather than strengthening the extremely poor coverage of the existing programme in most parts of the country especially in the large and populous states like Bihar and Uttar Pradesh.
Times Insight Group
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"The public has many questions about the safety and efficacy of vaccines. While more parents are showing increased concern about these issues and the growing number of vaccines to be administered to infants and children from day one of life, there is a growing interest on the part of vaccine manufacturers, state legislatures and medical societies to enforce vaccination on all children, through the passing of more and more state vaccine mandates, without first having a dialogue with the public, or the medical community." - Dr Lawrence Palevsky, MD. Pediatrician.
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