Coagulation and Adulteration — Building on Science and Policy Lessons from 1905 ( New Eng Jour Med)

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Interesting perspective on the science and politics of federal drug oversight - pinto.

Coagulation and Adulteration — Building on Science and Policy Lessons from 1905
Jerry Avorn, M.D.


It's always instructive and often painful to contrast the impressive development of medical science with the more fitful evolution of health policy. The former marches forward more or less systematically; well-developed rules of evidence determine what works, and practical methods build on established facts and test new paradigms. Data and concepts proven true are rarely discarded or forgotten.

Not so with health policy. Although the field's evaluation tools can be rigorous, in practice what is proclaimed "true" often depends on who's doing the proclaiming and whose interests are being represented. As a result, though medical science has progressed fairly steadily, pushing back the frontiers of our ignorance, the application of our collective wisdom in health policy, at least in the United States, has more closely resembled the movements of a planarian swimming through a solution of LSD.

Consider blood coagulation. In 1905, the German internist and physiologist Paul Morawitz published a seminal article on coagulation, including an exposition of how tissue factor leads to the generation of thrombin. In the ensuing years, other researchers extended these observations. Progress accelerated, with developments in pharmacology and molecular biology building on these foundations to produce new generations of drugs to accelerate or inhibit the coagulation cascade in ever more useful ways. A particularly elegant demonstration of the progress of that science is the elucidation by Kishimoto et al. in this issue of the Journal (pages 2457–2467) of the mechanisms by which the oversulfated chondroitin sulfate contaminating batches of heparin made in China can activate the kinin–kallikrein pathway to generate bradykinin as well as activate the complement system. This research clarifies precisely how the contaminant caused anaphylactoid reactions in many patients in the United States and Europe and draws an uninterrupted line connecting the biochemical and clinical data "from breach to bench to bedside."

The year that brought the world Morawitz's insights into coagulation also saw important developments in U.S. health policy. Several publications ran exposés of the unregulated patent-medicine industry. Because manufacturers did not have to indicate what was in their remedies, patients and doctors had no way of knowing what was being consumed. Often the secret ingredient was merely alcohol, with one popular medicine consisting only of 28% ethanol mixed with water. Many "soothing syrups" contained addictive compounds such as cocaine and opium, as well as other substances that were merely toxic.3 Contamination with impurities was common and usually undetected. These exposés helped to fuel the Progressive Movement, which envisioned a more activist role for government in protecting the public welfare. The same year that Morawitz published his coagulation paper, President Theodore Roosevelt called for a law to ensure the safety of the drug and food supply. Congress responded the following year by passing the first Pure Food and Drug Act, creating the forerunner of today's Food and Drug Administration (FDA).

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http://content.nejm.org/cgi/content/full/358/23/2429?query=TOC

Source Information

Dr. Avorn is a professor of medicine at Harvard Medical School, director of the Harvard Interfaculty Initiative on Medications and Society, and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital — all in Boston.

The New England Journal of Medicine is owned, published, and copyrighted © 2008 Massachusetts Medical Society. All rights reserved.