Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat
http://www.100md.com
《新英格兰医药杂志》
Fran Hawthorne, senior contributing editor of Institutional Investor and a veteran writer covering health care, is not shy about expressing her opinions concerning the successes and failures of the regulatory agency that oversees approximately one quarter of the U.S. economy. Along the way, however, she presents the reader with a thoughtful and relatively balanced discussion of numerous issues with which the Food and Drug Administration (FDA) has been involved during its 100-year history. A prominent theme is that the FDA increasingly has ventured beyond adjudication of scientific matters into controversies involving issues of public policy and ethics. That may not be bad, but Hawthorne counsels the FDA not to pretend that the agency is above the fray.
Hawthorne structures her discussion by highlighting the inherent tension between the FDA's two public health missions — ensuring the safety of food and medicines and helping to speed access to more effective and affordable innovations. Committing type I errors (approving unsafe products) historically has left the FDA vulnerable to attacks from Congress and victims' families, but the agency has also been criticized by industry and patient-advocacy groups for its handling of type II errors (maintaining regulatory barriers that stifle innovation and delay access to new products). The risks of both types of errors are illustrated by the FDA's interactions with the biotech firm Antigenics (the developer of a personalized medicine product that makes use of peptides isolated from a patient's own tumor), first by the FDA's waiving the required phase 1 assessment of safety in healthy volunteers, and then by its subsequently putting the phase 3 trial on partial clinical hold as missing but required paperwork is collected.
Hawthorne reviews the FDA's 100-year record in managing the risks associated with type I and type II errors, emphasizing the mixed record of alternately holding off and bending to pressures from industry (not just pharmaceuticals, but also — and especially — food and agriculture), consumers, and politicians. In her opinion, one of the worst records was in the 1980s, during which time President Ronald Reagan replaced Commissioner Jere Goyan with born-again Christian Frank Young, who lagged in dealing with the AIDS epidemic, bowed to industry pressure in not requiring warning labels for aspirin, oversaw the generic-drug bribery scandal, and was complicit in accepting FDA budget cuts and deregulatory policy initiatives. Since 1990, the agency has become embroiled in issues beyond simple assessments of safety and efficacy, such as being involved in international drug pricing and support of research and development, making public the results of all clinical investigations, confronting obesity and the American diet, attempting to regulate tobacco, and wavering on whether to approve emergency contraception (the "morning-after pill"). Hawthorne argues that although science still plays a prominent role at the FDA, the agency has increasingly become politicized.
Inside the FDA is not a scholarly history of the political economy of the FDA, as is Peter Temin's Taking Your Medicine: Drug Regulation in the United States (Cambridge, Mass.: Harvard University Press, 1980). However, it presents a thoughtful and insightful analysis of the FDA's changing equilibrium as it attempts to balance risks from type I and type II errors, particularly during the last quarter century.
Ernst R. Berndt, Ph.D.
Massachusetts Institute of Technology
Cambridge, MA 02142
eberndt@mit.edu(By Fran Hawthorne. 338 pp)
Hawthorne structures her discussion by highlighting the inherent tension between the FDA's two public health missions — ensuring the safety of food and medicines and helping to speed access to more effective and affordable innovations. Committing type I errors (approving unsafe products) historically has left the FDA vulnerable to attacks from Congress and victims' families, but the agency has also been criticized by industry and patient-advocacy groups for its handling of type II errors (maintaining regulatory barriers that stifle innovation and delay access to new products). The risks of both types of errors are illustrated by the FDA's interactions with the biotech firm Antigenics (the developer of a personalized medicine product that makes use of peptides isolated from a patient's own tumor), first by the FDA's waiving the required phase 1 assessment of safety in healthy volunteers, and then by its subsequently putting the phase 3 trial on partial clinical hold as missing but required paperwork is collected.
Hawthorne reviews the FDA's 100-year record in managing the risks associated with type I and type II errors, emphasizing the mixed record of alternately holding off and bending to pressures from industry (not just pharmaceuticals, but also — and especially — food and agriculture), consumers, and politicians. In her opinion, one of the worst records was in the 1980s, during which time President Ronald Reagan replaced Commissioner Jere Goyan with born-again Christian Frank Young, who lagged in dealing with the AIDS epidemic, bowed to industry pressure in not requiring warning labels for aspirin, oversaw the generic-drug bribery scandal, and was complicit in accepting FDA budget cuts and deregulatory policy initiatives. Since 1990, the agency has become embroiled in issues beyond simple assessments of safety and efficacy, such as being involved in international drug pricing and support of research and development, making public the results of all clinical investigations, confronting obesity and the American diet, attempting to regulate tobacco, and wavering on whether to approve emergency contraception (the "morning-after pill"). Hawthorne argues that although science still plays a prominent role at the FDA, the agency has increasingly become politicized.
Inside the FDA is not a scholarly history of the political economy of the FDA, as is Peter Temin's Taking Your Medicine: Drug Regulation in the United States (Cambridge, Mass.: Harvard University Press, 1980). However, it presents a thoughtful and insightful analysis of the FDA's changing equilibrium as it attempts to balance risks from type I and type II errors, particularly during the last quarter century.
Ernst R. Berndt, Ph.D.
Massachusetts Institute of Technology
Cambridge, MA 02142
eberndt@mit.edu(By Fran Hawthorne. 338 pp)