Cruise Control

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  • 01/13/2006

Bob Goldberg versus the Luddites. See below. Most current Vegas line is Goldberg 3-to-1 over Luddites.

Recently the FDA announced a new and better way to establish drug safety that solves a one of the more serious problems in drug development, namely that animal studies are often a poor and inaccurate substitute for what happens in human. For example, aspirin causes birth defects in mice but failed to do so in thalidomide. Penicillin failed to work in rabbits and was used in a sick patient as a last resort. Molecular genetics have allowed scientists to take microdoses of drugs and model the pharmacokinetics of a drug — how well the body will absorb, metabolize and get rid of a drug — with amazing accuracy — and the FDA has established a process for using these results gleaned from a small group of patients, rather than a less reliable animal studies, as a starting point for taking drugs through development.

Leave it to the feckless media to let the Luddites have the last word though without putting their reactionary perspective in context. Take for instance the article about the new approach in the LA Times … “Last time they speeded up the process of drug approval it led to the approval of lethal drugs,” said Vera Sharav of the Alliance for Human Research Protection, a patient advocacy group based in New York. “Now they are trying to fiddle around with the [earliest phase of] trials? Those, by definition, are the highest-risk.”

The FDA already has a system for accelerated approval of drugs that show promise in the course of full clinical trials, said Dr. Sidney Wolfe of Public Citizen, a consumer advocacy group that frequently criticizes the FDA. He questioned whether the agency had a strong enough scientific argument for speeding the early stages of drug research.

Let it be noted, since the LA Times did not do so, that Vera Sharav works closely with the Scientologists of Tom Cruise fame who believe that tuning into Thetans will cure all and that Sid Wolfe has opposed every effort to speed drugs to dying patients since he has been on his anti-patient jihad starting in 1970. According to a study conducted by MIT economist Ernst Berndt who looked at the impact of faster review times on patient health, there would be 50 fewer drugs on the market today if Sid Wolfe and his ilk had his way and those on the market would have taken 30 percent longer to reach patients. Wolfe has a self-interest in trashing new medicines since his organization makes money by hawking a book Worst Pills, Best Pills that argues the most drugs are dangerous.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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