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Drug Innovation Has Fallen Victim To Risk-Averse, Anti-Industry GovernmentBy Dr. Henry I. MillerMiller, a physician, is a fellow of Stanford Universitys Hoover Institution, An FDA official from 1979 to 1994, he is the author of To Americas Health: A Proposal to Reform the FDA (Hoover Institution Press, 2000).l In an article from Investors.com posted August 6, 2008 and entitled Drug Innovation Has Fallen Victim to Risk-Averse, Anti-Industry Government, Dr. Miller says, in part: “over the past decade the pharmaceutical industry has become a lightning rod for critics. Many influential members of Congress, in particular, have berated the FDA for being insufficiently concerned with drug safety and too cozy with industry. And the FDA leadership, ever a reed in the political winds, now finds itself in a gale that is blowing in the direction of a more imperious and adversarial posture toward drug companies. Risk-aversion is now the rule. As a result, at a time when drug development should have been spurred by the exploitation of numerous new technologies and huge increases in R&D expenditures which tripled to more than $45 billion between 1995 and 2007 drug approvals have actually dropped. The 19 new medicines approved last year was the lowest figure in 24 years. ” As the result of regulators risk-aversion and pandering to Congress dislike of the pharmaceutical industry, bringing a new drug to market now requires on average 12-15 years and costs more than $1.2 billion. And only one in five approved drugs garners sufficient revenue to recoup R&D costs for the manufacturer. The officials in the FDAs Office of Surveillance and Epidemiology are focused so narrowly on safety that they ignore the fact that because all drugs have side-effects, safety cannot be evaluated in a vacuum but must be part of a cost-benefit judgment. Their motto might be, “If you dont approve any new drugs, none will cause safety problems.” The bottom line: At a time when the U.S. population is aging and needs innovative new medicine for a wide spectrum of degenerative and infectious diseases, the nations drug regulator is increasingly inefficient, slow, poorly managed and risk-averse. Congressional oversight is misguided and self-promoting, more interested in public posturing than public health. We need public policy strategies that will lower the costs and time of development strategies that will stimulate the formation of new companies (the number of which is now shrinking) and enable them to pursue more drug candidates, including some that are medically needed but offer only modest revenue. In the meantime, the feds will continue to batter a once-robust industry and American will go on dying from reform. ” We at the Cancer Cure Coalition agree with Dr. Millers criticisms. We see the FDA now being confronted with a challenge: will it approve new breakthrough therapies for cancer, such as the gene therapy Advexin, and the vaccine therapies Provenge and G-Vax, or will it continue in its risk-avoidance strategy? We believe the FDA must act in a positive way to approve these therapies or, as Dr. Miller says, “Americans will go on dying for reform.”
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