The federal government was active in the regulation of health matters for most of the twentieth century. The Pure Food and Drug Act, under which all drugs are approved for sale in the United States, was passed in 1906; since then the federal government has taken an active role in protecting occupational health and public accountability. Early in the 1970s, corresponding to the general wave of public skepticism regarding professional and corporate claims of authority and trustworthiness, a citizen/consumer rebellion turned on the health professions. Seminal works by Eliot Freidson and others spearheaded a literature of public protest against professional privilege and urged vigorous and vigilant oversight of the health professions, medicine in particular.
The protest tended to portray state legislatures as weak, ignorant, or pawns of the powerful professions and urged a drastic widening of the federal oversight function. Such expansion was made possible by the passage of Medicare legislation (1965), followed by Medicaid and other programs that cast the federal government in the role of major funder of healthcare. In a 1976 report titled A Proposal for Credentialing Health Manpower, the U.S. Public Health Service recommended that a national certification commission be established "to develop, evaluate and oversee national standards" for agencies that certify healthcare personnel. The National Commission for Health Certifying Agencies was formed on that recommendation, charged with developing universal standards for credentialing healthcare personnel. This effort was supported through the 1980s by the U.S. Department of Health and Human Services, through the Health Resources and Services Administration (CSG/CLEAR).
The origins of consumerism are generally attributed to Ralph Nader, whose investigations of the safety of the American automobile alerted a generation to the possibility that the goods and services available from the trusted providers of the American marketplace might not be as good as advertised. A Nader offshoot, Public Citizen's Health Research Group, maintains that the disciplinary and regulatory powers and laws currently available to the American public are completely inadequate to the task. These groups have changed the broad direction of legislative action. In the era of consumerism, the people's authority exercised at the state or federal level now protects the consuming public from the professional provider instead of aligning itself with the professional against fraudulent competition.
In a return to the democratic assumptions of the nineteenth century, the mantle of legal and moral credibility as protector of the public has passed from the profession to the elected legislature: In the areas of technical expertise and professional wisdom, as well as in the areas of economic self-interest, the American voters are now assumed to be the best guardians of their own interests. Patients' autonomy vis-à-vis their physicians has been generalized to public autonomy vis-à-vis the profession as a whole.
Typical of consumerist initiatives in healthcare is congressional action requiring nationwide licensing of nurses' aides. The bill was demanded by, among others, AARP, an interest group of older Americans with a strong stake in the conduct of nursing homes and chronic-care facilities. The passage of the legislation at the federal level (incorporated into the Omnibus Budget Reconciliation Act [OBRA] of 1987) made the law immune to the objections of state organizations of such facilities. Now the states must implement this law.
Also typical are the regulations proceeding from the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established by Congress in the 1970s in response to claims that patients were being abused by their physicians in pursuit of scientific research (and that aborted fetuses were being used for research). The commission's work resulted in an immense number of federal regulations to protect the rights of human subjects of clinical research, including the formation of institutional review boards in any institution where such research is carried on, charged with reviewing all research that receives any federal money (in effect, all research in the institution).
A third example of such initiatives is the Patient Self-Determination Act, passed as part of the Omnibus Budget Reconciliation Act of 1990, which requires that healthcare providers inform adult inpatients of their rights to refuse treatment; to submit to the provider a document, generally known as a living will, specifying their desires regarding treatment or nontreatment should they become terminally ill and unable to give consent to treatment on their own; and to appoint any adult to speak for them to ensure that the living will's instructions are carried out, should they become unable to speak for themselves.
The contrast between profession-oriented and consumer-oriented approaches can be seen in the norms governing confidentiality of investigations of professionals charged with incompetence or negligence. If government is to protect the profession, then the identity of credentialed professionals who are under investigation for wrongdoing must be kept secret until it is determined that they are unsalvageable in the profession, so as to maintain their good name and practice. Consumer advocate groups, on the contrary, demand that the names of accused professionals be made public as soon as the investigation begins, so that the public can take steps to protect themselves.
Rejoinders to consumerism in healthcare have come from diverse sources. One very influential reply, from the perspective of the medical profession, is Charles L. Bosk's 1979 account of a surgical training program, Forgive and
Remember. In the training of surgical residents, as chronicled by Bosk, supervision was strict, the patients' interests were paramount, and discipline was swift, although generally informal, and highly effective. Bosk found in place an unwritten but well-understood set of rules, rapidly internalized by all surgical residents as a condition of success as surgeons and regularly enforced at all levels. The suggestion that emerged, although not explicitly, was that bureaucratic regulations could not possibly be as effective as this method of professional socialization in producing successful surgeons—at least at the level of the elite practitioners. On the other side, libertarian theorists have attacked regulation of all kinds, formal or informal, arguing that any regulation puts an artificial and uneconomic barrier in the free market. The libertarians achieved major gains in the last decade of the twentieth century.
Alternatives to licensing can easily be imagined. In 1984 Stanley J. Gross outlined a system of state registration of unlicensed practitioners whose competence is determined by the consuming public on the basis of full disclosure of background and skills. Given full disclosure and the absence of coercion, on the principle of freedom of contract, any two persons of mature years should be free to make between themselves any contract for goods and services. The point is primarily theoretical but of very wide application: If accepted, this doctrine would abolish a few dozen federal agencies and all state licensing and disciplinary functions. Concretely, this doctrine has been invoked as primary in cases in which patients request drugs not approved for distribution or sale, such as laetrile and other unproven cancer remedies or experimental AIDS drugs, or marijuana for medicinal purposes.
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