

How to Develop New Antibiotics - mhb
http://www.nytimes.com/2015/02/24/opinion/how-to-develop-new-antibiotics.html?smid=tw-share&_r=0

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reasonattlm
Regulation and the enormous unnecessary costs it imposes are the problem. That
is why in an era of radical and accelerating progress in biotechnology there
is ever diminishing clinical translation via the traditional channels.

[http://www.manhattan-institute.org/html/fda_05.htm](http://www.manhattan-
institute.org/html/fda_05.htm)

Though the United States urgently needs new treatments for common illnesses
such as heart disease, stroke, and diabetes, the nation’s system for drug
approval discourages innovation and investment, especially for our most
pressing public health challenges. In this paper, we find that the main
culprit is the high cost of Phase III clinical trials, which are required for
FDA approval of most drugs. We examined drug development in four major public
health areas and discovered that for any given drug on the market, typically
90 percent or more of that drug’s development costs are incurred in Phase III
trials. These costs have skyrocketed in recent years, exacerbating an already
serious problem.

The enormous cost and risk of Phase III trials create incentives for
researchers and investors to avoid work on medications for the chronic
conditions and illnesses that pose the greatest threat to Americans, in terms
of health spending and in terms of the number of people affected. This
avoidance, in turn, harms overall U.S. health outcomes and drives up the cost
of health care.

[http://jco.ascopubs.org/content/28/17/2925.abstract](http://jco.ascopubs.org/content/28/17/2925.abstract)

Increasing the regulatory rigidity of clinical trials (regulatory
fundamentalism) augments trial complexity and costs while slowing progress
without demonstrating meaningful safety benefits. Time from drug discovery to
marketing increased from 8 years in 1960 to 12 to 15 years currently. Toxic
death rates on phase I trials have decreased from 0.8% in 1979 to 0.5% by
2002, but the estimated cost per life-year gained by tighter regulations is
$2,700,000 (far higher than costs of other health measures), and simulations
suggest that regulatory delays in development of effective therapies result in
tens to hundreds of thousands of life-years lost, whereas stringent
regulations save extremely few.

