The connection between GlaxoSmithKline's Lapdap and MHRA Chairman Alisdair Breckenridge.
GlaxoSmithKline Plc is scrapping two malaria drugs that may cause anemia, dealing a blow to the global fight against the killer disease, writes Ben Hirschler.
Europe's biggest drugmaker said it was pulling Lapdap from the market in Kenya -- the only place where it has recently been sold.
Lapdap has been linked to reductions in hemoglobin levels in patients with a hereditary enzyme disorder that affects 10 to 25 percent of Africans. Low hemoglobin can lead to anemia which in severe cases may require a blood transfusion.
Lets first start with GlaxoSmithKline and move on to Breckenridge later.
There has been progress in malaria too. In October 2002, we submitted a regulatory application to the UK Medicines Control Agency (MCA) for Lapdap (chlorproguanil/dapsone) for the treatment of the most life threatening type of the malaria. MCA approval will be an important step in making Lapdap available across Africa, where there is great need for new malaria treatments.
Lapdap results from a successful partnership between GSK, the World Health Organization, the University of Liverpool, the London School of Hygiene & Tropical Medicine, and the UK Department for International Development (DFID) This is the first such product development to be directly sponsored by DFID.
The University of Liverpool?
Professor Sir Alasdair Breckenridge, CBE, was most recently Professor of Clinical Pharmacology at the University of Liverpool.
He has been Chair of the Committee on Safety of Medicines (CSM) since 1999, a role which he relinquished when he became chair of the MHRA on its creation in April 2003.
The University of Liverpool has capitalised on 15 years' research by initiating a Public Private Partnership to turn promising lab results into an affordable anti-malarial treatment which can combat drug resistance in Africa.
In the 2003 University of Liverpool Annual Report there is a full page spread 'bigging up' Lapdap. The blurb reads:
Fighting malaria: Professor Peter Winstanley has led the development of a new low-cost anti-malarial drug LapdapTM, designed for sub-Saharan Africa where ‘Plasmodium falciparum’ malaria kills one to two million people every year.
It continues...
GLAXOSMITHKLINE (GSK) WILL MARKET THE AFFORDABLE NEW DRUG. LAPDAP HAS BEEN DEVELOPED THROUGH A UNIQUE PUBLIC-PRIVATE PARTNERSHIP BETWEEN THE UNIVERSITY, THE WORLD HEALTH ORGANISATION, GSK, THE GOVERNMENT’S DEPARTMENT FOR INTERNATIONAL DEVELOPMENT (DFID), THE LIVERPOOL SCHOOL OF TROPICAL MEDICINE AND THE LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE, WITH GRANT SUPPORT FROM THE WELLCOME TRUST.
The Medicines and Healthcare products Regulatory Agency (MHRA) - The FDA's equivalent in the UK - need a thorough impartial investigation. Their own Chief Executive refuses to budge on his stance that Seroxat (Paxil) is safe.
See http://fiddaman.blogspot.com/ for more information
