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AIDS Responsibility Project
Friday, September 10, 2010 









Statement by Abner Mason, executive director of AIDS Responsibility Project on the World Health Orga
June 23, 2004
 
"On May 27, the World Health Organization de-listed two AIDS drugs: single dose Lamivudine 150mg tablets and double dose Lamivudine plus Zidovudine 300mg tablets  both manufactured by Indian drug company, Cipla.

The WHO states these two drugs were 'removed from the list as a result of the outcome of an inspection performed by the World Heath Organization in which compliance with Good Clinical Practices and Good Laboratory Practices was assessed, as well as data verification of the bioequivalence study at the Contract Research Organization used by the sponsor. Products are subject to re-assessment when completely new data set is presented about the bioequivalence studies.'

The WHO inspections is a positive development  moving the WHO closer to ensuring AIDS patients are receiving medicines that are safe, efficacious and effective in the treatment of HIV/AIDS.

However, questions still remain following Friday's statement by the WHO:

  • Will Cipla guarantee that other pre-qualified AIDS drugs it manufactures such as the triple dose Triomune, which uses Lamivudine, pass further inspection site reviews and bioequivalence studies?
  • Could WHO and Cipla provide a roadmap as to how they will inform procurement agencies, distributors and administrators that these AIDS drugs have been recalled from the market?
  • Could the WHO and Cipla provide the number of AIDS patients currently under therapeutic treatment using single dose Lamivudine 150mg tablets and double dose Lamivudine plus Zidovudine 300mg tablets?
  • Does WHO or Cipla plan to provide post-marketing evaluation of patients to determine if these recalled AIDS drugs have promoted HIV resistance?
  • Does Cipla plan to provide appropriate alternative therapeutic treatment for AIDS patients currently being treated with the de-listed single dose Lamivudine 150mg tablets or double dose Lamivudine plus Zidovudine 300mg tablets?
  • Could Cipla explain the discrepancies in the bioequivalence data it first provided the WHO over 3 years ago in 2001 versus the data reviewed that led to the de-listing May 27?

No doubt the WHO and Cipla have a roadmap in place to inform AIDS patients around the world that these drugs have been recalled from the market, that AIDS patients will receive appropriate therapeutic treatment in substitution for the recalled Cipla drugs and provide a full accounting of all bioequivalence data on all Cipla manufactured AIDS drugs. We look forward in the coming days to witnessing the roadmap by both the WHO and Cipla at the behest of AIDS patients worldwide."


View photos from several AIDS Responsibility Project events from across the globe here..
As a result of our successful trip to Latin America, ARP has established a Stigma Reduction Program in Mexico and Brazil.
The AIDS Responsibility Project recently traveled to Africa to view first-hand the impact of the disease on the continent, and the challenges facing those who provide services to these people.
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