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More resources on Information for Patients

Book Review of "Democracy By Disclosure" Published in the NEJM

This review appeared in the May 8, 2003 edition of the New England Journal of Medicine.

Democracy By Disclosure: The Rise of Technopopulism by Mary Graham. 201 pp. Washington, D.C., Brookings Institution Press and the Governance Institute, 2002. $24.95. ISBN 0-8157-3234-1.

In the United States, there are three ways to achieve a transfer of power from the producers of goods or services to the public in order to improve health and safety. The first is traditional federal or state regulation, wherein laws enable governmental regulatory agencies, acting on behalf of the public, to hold industries accountable by means of standards, approval processes, and penalties and other sanctions for noncompliance. The second involves civil litigation, through which injured people can seek financial redress from producers of goods and services that have harmed them. The third is the power of accurate information to influence choices made by members of the public individually and collectively. The proper functioning of all three, often working together, is important in a democracy.

In her thoroughly researched and well-written book, Democracy by Disclosure, Mary Graham uses three case studies to illustrate both the promises and serious problems inherent in government-mandated public disclosure of standardized information as one strategy for helping people to reduce health and safety risks. The first case involves the Emergency Planning and Community Right-to-Know Act, which went into effect in 1986 as part of the Environmental Protection Agency's legal responsibilities. The act created the Toxics Release Inventory, a nationwide compendium from manufacturers of annual releases of toxic chemicals into the environment. The second, the Nutritional Labeling and Education Act of 1990, which requires standardized nutritional content labeling on processed food products, became fully effective in 1994. The third is the effort, as yet unsuccessful, to implement recommendations from the 1999 report on medical errors published by the Institute of Medicine (IOM) (To Err Is Human: Building a Safer Health System), which estimated that as many as 98,000 patients die each year as a result of errors in hospitals.

Referring to Justice Louis Brandeis's famous statement that "Publicity is justly commended as a remedy for social and industrial diseases. Sunlight is said to be the best of disinfectants,"Graham discusses the potential power of publicity, especially adverse publicity, and argues that "such disclosure systems supplement well-developed regulatory institutions that aim to reduce health and safety risks by means of rules and financial incentives." In her book, Graham recounts how the final forms of both the Toxics Release Inventory and the Nutritional Labeling and Education Act were seriously compromised by enormous political pressures, usually emanating from the regulated industries (or professions). For the Toxics Release Inventory, the disclosed data did not include many chemicals, failed to include information about the extent of human exposure and risks, was often based on approximations that underestimated the amounts of the toxic substances, and was issued to the public long after the chemicals had been released into the environment. In the case of the Nutritional Labeling and Education Act, pressure from the fast-food industry succeeded in exempting fast foods — among the most nutritionally dangerous foods — from the requirement for nutritional labels, and restaurants were similarly exempted. Further pressure prevented requirements that nutritional labels identify health risks. Last-minute lobbying resulted in the separation of dietary supplements from other foods regulated by the act, and consequently lower standards were instituted for health claims for dietary supplements.

Despite these unfortunate, though predictable, industry-induced flaws and Graham's admonition that "disclosure systems have been systematically oversold," the Toxics Release Inventory and the Nutritional Labeling and Education Act at least got off the ground. This standardized, government-mandated information is important in the transfer of power in these two examples of democracy by disclosure. Not so for the third example, the implementation of the IOM's recommendations concerning preventable errors that injure and kill patients. The recommendations were prefaced by the statement that "the goal of this report is to break this cycle of inaction. The status quo is not acceptable and cannot be tolerated any longer... It is simply not acceptable for patients to be harmed by the same health care system that is supposed to offer healing and comfort."

To achieve their proposed goal of a 50 percent reduction in errors by 2005, the IOM recommended that there be a nationwide mandatory reporting system for serious errors — those that result in death or serious harm — for hospitals, other institutional providers, and ambulatory care systems, and that some of the data collected should be made publicly available. The IOM argued that such a system ensures a response to reports of serious harm, holds organizations and providers accountable for maintaining safety, responds to the public's right to know, and provides incentives to health care organizations to implement safety systems that reduce the likelihood that such events will occur. Opposition from the American Medical Association (AMA) and the American Hospital Association, among others, has succeeded in thwarting efforts to implement this critical IOM recommendation.

Other examples in the health care sphere of failed efforts at public disclosure of standardized, government-mandated information include patient-information leaflets approved by the Food and Drug Administration, which were about to be required in 1981 for many prescriptions dispensed, and the important information concerning doctors who have been disciplined by medical boards and hospitals and payouts in malpractice suits against doctors, which is found in the federal National Practitioner Data Bank. Months before the patient-information leaflets were to become required, strong opposition from pharmacists, physicians, and the pharmaceutical industry killed the program. Last-minute lobbying by the AMA in 1986 forced Congress to insert a secrecy clause into the operation of the National Practitioner Data Bank so that neither patients nor physicians — only medical boards, hospitals, and health maintenance organizations — have access. Despite this federal prohibition on disclosure, an increasing number of state medical boards are starting to make some of this information public.

Graham states that "disclosure systems could mimic problems endemic to more conventional forms of regulation" and that disclosure is "a useful variation on regulation but not an escape from its challenges." To provide the greatest possible protection for the public, we need a resurgence in traditional regulation and — aided by the Internet and Graham's suggestions, including the matching of disclosure to risk and the designing of accurate metrics and reporting — a more substantial implementation of democracy by disclosure.

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