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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