Saturday, May 25, 2013

Pentavalent in India: Twisting data to justify a killer vaccine

New Far East Killer Vaccine

For the entire article:

So far, 21 have so far died in India in a limited experiment with the vaccine. Last week the Vietnamese Government´s Drug Regulatory Authority stopped the new form of vaccine – a Pentavalent vaccine – after the vaccine caused nine death.
The new vaccine was introduced because vaccine uptake for the previous vaccine has been poor.  The new vaccine is a combination vaccine; a Pentavalent vaccine.  This vaccine combines Hib and Hepatitis B vaccine with the widely used DPT vaccine. The vaccine is not licensed for use in the West but is promoted in Asia.
The Minz Study, a comprehensive, 2-years study sponsored by the WHO, found an incidence of Hib meningitis of  7/100000 children under-five.  The figure for a saving of 175 deaths in 5 years is suggested by a mortality of 10%.
The present paper and its commentary were published this week in the Indian Journal of Medical Research in this context.
The article by Padmanabhan Ramachandran and colleagues available here suggests:
1.       Hib was found to be the predominant cause of bacterial meningitis in young children.  Hib meningitis was responsible for 58% to 74% of children with abnormalities in the Cerebro Spinal Fluid, CSF.
2.       41% in Vellore are immunized against Hib and that is why the proportion of Hib was 58% here compared to 74% elsewhere.
3.       Hib accounted for 70% of bacteriologically confirmed meningitis.
An invited commentary accompanying the article is entitled
1.       It shows that the Hib antigen was detected only in 8.75 per cent of patients with an abnormal CSF cytology and not 74% or 58% as suggested in the article.
2.   There were only 7 cases of Hib meningitis in Vellore and one was vaccinated. The incidence of meningitis among those vaccinated in Vellore was not statistically different from those unvaccinated.
3. The Latex agglutination Test (LATS) used by the study to detect the cause of meningitis, picks up 93% cases of Hib but only 39% Neisseria meningitides. Thus LATS cannot be used to look at the relative incidence of different causes of meningitis.
Conflict of Interests
The commentary says that one of the authors has a declared conflict of interest. Quoting Als-Nielsen and colleagues the reviewer says such conflict of interests has little impact on the results or data reported but it influenced the interpretation of the results and the conclusions drawn. “The fact that the data are not impacted by conflicts of interest provides persuasive reason to publish the figures from large trials such as this, regardless of the declared conflicts of interests. Publication allows data to be put out in the public domain. It can be interpreted by the scientific community, separately from the interpretations of the authors. Discerning readers and decision makers can use the data provided for health policy, based on sound cost–benefit calculations”

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