Lapdap. GlaxoSmithKline and The MHRA

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.

Europe's biggest drugmaker said on Friday it was pulling Lapdap from the market in Kenya -- the only place where it has recently been sold -- and stopping development of a second experimental compound called Dacart.

Both medicines have 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.

In 2002, talking of Lapdap, GlaxoSmithKline said:

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? Hmmm

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.

Breckenridge, along with Peter Winstanley, Stephen Ward, Robert Snow, wrote a paper entitled: Therapy of falciparum malaria in sub-saharan Africa: from molecule to policy.

In it, they wrote:

The burden of falciparum malaria remains as great as ever, and, as has probably always been the case, it is carried mainly by tropical Africa. Of the various means available for the control of malaria, the use of effective drugs remains the most important and is likely to remain so for a considerable time to come.

And what would that 'effective drug' be?

Lapdap - The outcome of a successful partnership between GlaxoSmithKline and The University of Liverpool - Coincidently where Sir Alisdair Breckenridge was Professor of Clinical Pharmacology.

Not so successful now Lapdap has been linked to reductions in hemoglobin levels in patients which can lead to anemia!

Alisdair Breckenridge is currently Chairman of the MHRA. The regulator that 'regulates' the drugs you and I take.

He has also defended Seroxat

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