Drug "Crisis" a Ruse, Docs Say

 

The widely publicized claim that the development of new drugs is moving at glacial speed is "a myth", according to the authors of an article published in the British Medical Journal. Donald W. Light, PhD, of the University of Medicine and Dentistry of New Jersey in Cherry Hill, N.J. and Joel R. Lexchin, MD, of York University in Toronto contend that the real problem is thecurrent incentives that reward Big Pharma for developing large numbers of new drugs with few clinical advantages over existing ones.

"This is the real innovation crisis," they wrote. "Pharmaceutical research and development turns out mostly minor variations on existing drugs, and most new drugs are not superior on clinical measures." Yetaccording to the article BMJ, an investigation by the Wall Street Journal in 2002 reported that “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.”In 2006, a US Government Accounting Office assessment of new drug development stated 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.”And as recently as 2010, Morgan Stanley reported that executives felt they could not “beat the innovation crisis” and proposed that the best way to deal with the issue was for the major companies to stop trying to discover new drugs.

"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 authors wrote."This hidden business model for pharmaceutical research, sales, and profits has long depended less on the breakthrough research that executives emphasize than on rational actors exploiting ever broader and longer patents and other government protections against normal free market competition." As a solution the authors recommend that regulatory agencies should make requirements for new drug approvals more difficult to achieve. "The low bars of being better than placebo, using surrogate endpoints instead of hard clinical outcomes, or being non-inferior to a comparator, allow approval of medicines that may even be less effective or less safe than existing ones," they aver. According to MedPage Today, Light and Lexchin backed a proposal by Sen. Bernard Sanders to "give large taxpayer-funded cash prizes to companies that deliver real improvements in healthcare, but allowing generic competition to begin immediately in order to keep costs to patients and payers relatively low." They argued that this would mean "innovators are rewarded quickly to innovate again."  
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