Tuesday, July 23, 2013

Glaxo in China: Another Step in Big Pharma’s Race to the Bottom

GlaxoSmithKline has been much in the news lately. Following a scandal where Glaxo executives apparently bribed Chinese physicians and hospital officials to promote use of GSK drugs, it now turns out that there are also major problems at GSK’s shiny new research center in Shanghai, as recently described in the NY Times.   Apparently key pre-clinical studies in animals were not reported (misplaced? suppressed?) before an important new drug went into clinical trials.  Ozanezumab, a monoclonal antibody for treatment of neurological diseases was being developed at the Shanghai facility when problems emerged during an internal audit in 2011 that has only recently become public.  Evaluating animal studies prior to initiation of clinical trials is crucial to protecting patients in the trials against potential harmful effects of the new drug.  An excerpt from the Times article highlights the issue ““If that’s true, it’s a mortal sin in research requirements,” said Arthur L. Caplan, the head of the division of medical ethics at NYU Langone Medical Center. “No one could approve human trials without having that information available, scientifically or ethically. That’s kind of a Rock-of-Gibraltar-sized ethics violation.”  As bad as it is, this is not the first scandal to hit GSK’s China operations. A few months ago the head of GSK R & D in China was fired for misrepresenting data in an article published in Nature Medicine.

So is this just an isolated case? I doubt it. Over the last decade or so big Pharma has sought to maximize profits by reducing expenditures for research, personnel, and materials.  To a considerable extent this has been done by seeking lower cost alternatives in China and other less developed countries. Thus research staff at sites in the US and Europe have been cut while new sites have been created in Asia. Production of the ingredients to make existing drugs has been outsourced to companies in India and elsewhere. The problem with this is that it is not only costs that are being cut, but quality as well.

As described elsewhere on this blog (1) there have been numerous problems with drugs produced by foreign manufacturers for the US market. Now it is emerging that research results from big Pharma’s outsourced labs can’t be trusted either. It is not that Asian researchers can’t do good science. More and more outstanding work is emanating from academic laboratories in China, India, Taiwan, Singapore and other Asian countries. However, when commerce enters the picture scientific probity seems to go out the window.

It makes one wonder whether we should entrust our future needs for important new drugs to the current profit driven system represented by the big pharmaceutical companies. There are other models for drug development (2) including the public-private partnerships that have been so successful in developing drugs for malaria and other neglected diseases. Some new approaches are clearly needed.

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