Adverse Reactions

Overview

Miracle cure or lethal medicine? In 1949, chloramphenicol was hailed as the greatest drug since penicillin and proved amazingly effective against a host of previously untreatable deadly diseases. Marketed as Chloromycetin, it made its manufacturer, Parke-Davis, the largest pharmaceutical company in the world. But it was marred by a tragic flaw. Three years later, in 1952, Dr. Albe Watkins, a California general practitioner, inadvertently killed his own ten-year-old son with chloramphenicol. After learning that ...
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Overview

Miracle cure or lethal medicine? In 1949, chloramphenicol was hailed as the greatest drug since penicillin and proved amazingly effective against a host of previously untreatable deadly diseases. Marketed as Chloromycetin, it made its manufacturer, Parke-Davis, the largest pharmaceutical company in the world. But it was marred by a tragic flaw. Three years later, in 1952, Dr. Albe Watkins, a California general practitioner, inadvertently killed his own ten-year-old son with chloramphenicol. After learning that Parke-Davis already knew about other chloramphenicol-related deaths, Watkins embarked on an extraordinary cross-country pilgrimage that led the Food and Drug Administration to launch one of the largest investigations in medical history. Chloramphenicol saved too many lives to be taken off the market, but at the same time, it proved impossible to control. During three decades of FDA and American Medical Association warnings, half a dozen congressional hearings, and hundreds of lawsuits, doctors continued to prescribe the drug for trivial infections, needlessly killing more than a thousand people. In the 1980s, potentially lethal chloramphenicol residues were detected in U.S. dairy and beef cattle. In the 1990s, the FDA has found the drug in imported shrimp. How could this have happened? In seeking the answer to that question, Adverse Reactions provides a panoramic perspective over nearly half a century of the changing relationship among the pharmaceutical industry, the medical profession, the government, and patients, revealing how and why important decisions were made that affect us all today. To tell both sides of the story, Thomas Maeder has interviewed hundreds of people, from the man who dug up the sample of Venezuelan compost in which chloramphenicol was discovered, to the company scientists and executives who developed and marketed it, FDA officials who investigated and regulated it, families bereaved by it, lawyers who fought the issues in court, l
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Editorial Reviews

Publishers Weekly - Publisher's Weekly
``No drug is completely safe,'' cautions medical writer Meader ( Children of Psychiatrists ) in introducing this involving, instructive ``biography'' of one still-controversial drug, Chloromycetin, a highly profitable ``miracle'' antibiotic released in 1949 and administered to some 40 million Americans in the 1950s for a wide spectrum of infections ranging from dysentery to mononucleosis. Within three years, it became clear that the drug caused aplastic anemia, often fatal, in a small proportion of those taking it, and an investigation was launched by the FDA. Meader pursues the story of the drug's development, tracking its widely accepted efficacy and examining Parke-Davis's marketing campaigns; he also interviewed physicians, medical researchers and personnel of drug manufacturers and federal agencies, along with the drug's victims and their relatives. Congressional hearings about misleading promotions and inadequate warnings to physicians of the drug's danger contributed to the passage in 1962 of the Kefauver-Harris Amendments instituting tighter drug regulation. (Apr.)
Library Journal
Chloramphenicol, a broad-spectrum antibiotic, was hailed as a miracle drug that saved thousands of lives when first introduced in 1949. Unfortunately, a small number of people who took it also developed aplastic anemia, a devastating and usually fatal disease. For decades after this ``adverse reaction'' was discovered, chloramphenicol was still widely and inappropriately prescribed by physicians throughout the world. While chronicling this controversy, Maeder ( Children of Psychiatrists , LJ 2/1/89) also provides some historical perspective on the relationships among the pharmaceutical industry, physicians, and the Food and Drug Administration, but he offers little discussion on how they should have handled the chloramphenicol situation or how how they could work together to evaluate the risks of a particular drug againsts its benefits. Recommended for historical medical or pharmacy collections only. Previewed in Prepub Alert, LJ 12/93.-- Kathleen McQuiston, Philadelphia Coll. of Pharmacy and Science
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Product Details

  • ISBN-13: 9780688116828
  • Publisher: HarperCollins Publishers
  • Publication date: 4/28/1994
  • Edition description: 1st ed
  • Pages: 480

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