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Pharma innovation crisis a ‘myth’, say experts

The oft-reported “innovation crisis” in pharmaceutical R&D is a myth, according to a report in the British Medical Journal.

The true crisis is that 85 per cent to 90 per cent of new products introduced in the past 50 years have provided “few benefits and considerable harms”, say authors Donald Light of the University of Medicine and Dentistry of New Jersey in the US and Joel Lexchin of York University, Canada.

They also accuse US companies of spending more of their revenues on marketing (25 per cent) than on discovering molecules (1.3 per cent).

The Association of the British Pharmaceutical Industry says it strongly disagrees with the claims.

Chief executive Stephen Whitehead said, “The pharmaceutical industry’s medicines pipeline is promising with many new treatments in development. But the discovery of medicines is an increasingly difficult process as the cost of research and development continues to rise and regulation becomes more onerous.”

Light and Lexchin say that such complaints are at odds with records from the US Food and Drug Administration showing that drug companies “have delivered innovation at a constant rate for almost 60 years”.

The report, published on 8 August, suggests too many drugs are produced with little or no important therapeutic gains because approval bars are set too low: for example, new drugs have only to be better than a placebo, not better than existing drugs.

Whitehead argues that in 2012 “it costs on average over £1 billion to develop a new medicine”, but Light and Lexchin say that “companies exaggerate costs of development” and that “although reported research and development costs rose substantially between 1995 and 2010, by $34.2bn, revenues increased six times faster, by $200.4bn”.

Big pharma uses these “overinflated estimates” to “lobby for more protection from free market competition”, they say.

The report’s authors recommend that a clause looking at the “medical need” for a drug be applied when approving new treatments and that regulatory bodies be fully funded by public funds to “end industry’s capture of its regulator”.