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His brilliant career: John E. Calfee recalls the story of Maurice Hilleman and a remarkable period of industrial scientific research. It yielded the most cost-effective medicines ever made. And it holds lessons for today.

Publication: The American (Washington, DC)
Publication Date: 01-NOV-08
Format: Online
Delivery: Immediate Online Access
Full Article Title: His brilliant career: John E. Calfee recalls the story of Maurice Hilleman and a remarkable period of industrial scientific research. It yielded the most cost-effective medicines ever made. And it holds lessons for today.(RESEARCH AND DEVELOPMENT)

Article Excerpt
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The pharmaceutical industry has been under attack for longer than most people realize. In the 1950s and 1960s, when for the first time in history we had quite a few drugs that worked very well--including many antibiotics, the first miracle drugs--there was the full panoply of congressional hearings, outraged newspaper editorials, and dour experts who described an industry in which prices were too high, marketing too important, and innovation in decline amid a flood of "me-too" drugs barely distinguishable from the original innovative brands. But I doubt that the atmosphere then was as hostile as it has been in the past five years or so. A flood of books, including some by authors with academic credentials, have recirculated many of the same arguments (albeit with more emphasis on safety). The more scholarly works include Merrill Goozner's The $800 Million Pill: The Truth Behind the Cost of New Drugs; Jerome Kassirer's On The Take: How Medicine's Complicity with Big Business Can Endanger Your Health; and Jerry Avorn's Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. Others have a more muckrakian tone, beginning with the much-quoted The Truth About the Drug Companies by former New England Journal of Medicine editor Marcia Angell, and continuing on to many others including Ray Moynihan and Alan Cassels's Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients; Howard Brody's Hooked: Ethics, the Medical Professions, and the Pharmaceutical Industry; Alison Bass's Side-effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial (about the drug Paxil); and Philip R. Lee's Pills, Profits, and Politics.

What's with R&D?

To my mind, the most serious of these indictments focus on industry research. No doubt, the stakes are high for the industry. If drugs are truly innovative life-modifiers or life-savers, the argument over prices and spending tends to be marginalized. But if there hasn't been a lot of innovation and if the innovation we do get comes mainly from the taxpayer-supported National Institutes of Health and other nonprofit organizations, the politics of drugs becomes difficult for the industry to handle.

I have had occasion to write about innovation and its sources in the pages of THE AMERICAN. AS I explained in "The Golden Age of Medical Innovation" (March/April 2007), the critics have paid too much attention to the annual count of new drug approvals by the FDA and too little attention to two crucial developments. One is the increasing importance of research that occurs after a drug is approved. Newer drugs, especially so-called biotech drugs including monoclonal antibodies, involve complex biological processes that are themselves subject to ever more sophisticated research on everything from DNA to drug interactions. Basic research and clinical trials have been running side by side, often with drugs themselves serving as research tools to find out what happens when a particular receptor...

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