martes, 11 de septiembre de 2012

Esto es crisis(I)...: Pharmaceutical research and development: what do we get for all that money?



Since the early 2000s, industry leaders, observers, and policy makers have been declaring that there is an innovation crisis in pharmaceutical research. A 2002 front page investigation by the Wall Street Journal reported, “In laboratories around the world, scientists on the hunt for new drugs are coming up dry . . . The $400 billion a year drug industry is suddenly in serious trouble.” Four years later, a US Government Accounting Office assessment of new drug development reported that “over the past several years it has become widely recognized throughout the industry that the productivity of its research and development expenditures has been declining.” In 2010, Morgan Stanley reported that top executives felt they could not “beat the innovation crisis” and proposed that the best way to deal with “a decade of dismal R&D returns” was for the major companies to stop trying to discover new drugs and buy into discoveries by others. Such reports continue and raise the spectre that the pipeline for new drugs will soon run dry and we will be left to the mercies of whatever ills befall us.


The innovation crisis starting in 1997 is a return to the long term average range of new approvals from an artificial spike caused by political factors

The rate of approval of new molecular entities returned to the long term average range by 2006

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A subsequent analysis also concluded that the innovation crisis was a myth and added several insights. Based on US Food and Drug Administration records, Munos found that drug companies “have delivered innovation at a constant rate for almost 60 years.” The new biologicals have been following the same pattern “in which approvals fluctuate around a constant, low level.” These data do not support frequently heard complaints about how hard it is to get any new drug approved. They also mean that neither policies considered to be obstacles to innovation (like the requirement for more extensive clinical testing) nor those regarded as promoting innovation (like faster reviews) have made much difference. Even the biotechnology revolution did not change the rate of approval of new molecular entities, though it changed strategies for drug development. Meanwhile, telling “innovation crisis” stories to politicians and the press serves as a ploy, a strategy to attract a range of government protections from free market, generic competition.


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