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[e-drug] Polio and paralysis in India

E-DRUG: Polio and paralysis in India 
-----------------------------------

Dear friends,

  Polio vaccine and paralysis in the media 
  From
  Dr Gopal Dabade,
  57, Tejaswinagar,
  Dharwad 580002, INDIA
  http://boycottnovartis.blogspot.com/
  dabadedr@yahoo.com 
   
  http://www.telegraphindia.com/1070714/asp/frontpage/story_8058219.asp#
  THE TELEGRAPH
  Issue Date: Saturday, July 14, 2007
  Cover-up cloud on vaccine
  Doctors suspect paralysis link, officials pooh-pooh
  G.S. MUDUR       New Delhi, July 13: 

India?s polio eradication managers introduced a new polio vaccine into the 
country two years ago without informing the public that the vaccine was still 
new and experimental at the time, a medical team has claimed.
  In a letter that will appear in the leading medical journal The Lancet on 
Saturday, a doctor and two public health specialists have questioned the manner 
in which this vaccine was introduced, claiming it involved ?serious ethical 
issues?.
  The doctors have also questioned whether there is a connection between an 
observed rise in unexplained paralysis among children in UP and Bihar and the 
introduction of this vaccine.
  Health officials have rubbished this concern as baseless, arguing that the 
rise in paralysis is due to a dramatically intensified surveillance system in 
which even ?mild weakness in a limb? may initially be classified as acute 
flaccid paralysis.
  In a new strategy to tackle polio in areas where the wild poliovirus has 
persisted despite multiple doses of the standard oral polio vaccine, India had 
introduced a monovalent oral polio vaccine (mOPV1) in some parts of the country 
in 2005.
  The decision to introduce the vaccine was taken in consultation with 
international health agencies because mOPV1 which targets only type 1 of polio 
was expected to be more effective than the standard trivalent-OPV which 
protects against type 1, 2, and 3. A study published earlier this year had 
indeed showed that mOPV1 was three times more effective than the trivalent OPV.
  When mOPV1 was introduced into the immunisation programme, scientists found 
that each dose protected 30 per cent of children instead of 11 per cent 
protection offered by the traditional vaccine.
  But sections of the medical community who have been expressing their concerns 
about how mOPV1 was introduced in India have now articulated their views in The 
Lancet .
  ?No informed consent was taken, nor was the public told that the vaccine was 
experimental. In fact, the truth was carefully hidden from the public and 
doctors in India,? Jacob Puliyel, a paediatrician at the St. Stephen?s Hospital 
in New Delhi, and his co-authors said. ?Efforts were made to give the 
impression that the monovalent vaccine was not new but just the monovalent 
vaccine used in the 1960s.?
  Health officials have asserted that the monovalent vaccine was ?not new? and 
had been used previously. A National Polio Surveillance Project (NPSP) official 
also told The Telegraph today that mOPV1 is ?essentially not new?.
  ?This vaccine had been used earlier in South Africa, Brazil and Uganda until 
the 1980s and 1990s,? Hamid Jafari, project manager of the NPSP said. ?A 
similar vaccine was also tested in India earlier,? he said.
  However, in a paper earlier this year, Indian, NPSP, and World Health 
Organisation officials had described mOPV1 as ?a new vaccine that possesses 
five times the potency of the licensed monovalent vaccines used in the 1960s?.
  The officials said an advisory committee on polio eradication had recommended 
the ?rapid development, licensing, and introduction? of a new mOPV1. The 
vaccine was first approved in France, introduced in Egypt and brought into 
India in April 2005.
  ?Our objection is over the deception of telling the public that it was an old 
vaccine,? Puliyel told The Telegraph. ?Is this ethical practice in medicine??
  ?If this was not a new vaccine, why would it require regulatory approval and 
a clinical trial,? asked Joseph Mathew, a paediatrician at the Postgraduate 
Institute of Medical Education and Research in Chandigarh.
  Mathew and another pediatrician Santosh Mittal had said earlier this year 
that a ?phase four? clinical trial had been built into the introduction of the 
mOPV1 in India.
  The count of unexplained paralysis has risen in UP and Bihar to 12 per 
100,000 over the past three years, several times higher than the expected 
average of less than 2 per 100,000. But NPSP officials have said this increase 
has nothing to do with the vaccine, but is the result of improved surveillance. 
  ?These concerns have no basis. The vaccine has been used in 20 other 
countries now, and nowhere is there any evidence for any side effects despite 
extensive post marketing surveillance,? Jafari said.
     
       

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