AIDS is having a dramatic effect on our society. As a result, a consumer movement has been formed which is seeking to change the way drugs are tested and used. In response, the FDA has slowly begun to make some changes in its drug policies. This paper documents the policy battle that is underway and suggests that it may lead to a shift in health care policy extending beyond AIDS to all diseases. Implications and recommendations are also considered.
Get full access to this article
View all access options for this article.
References
1.
AbramsDonald, GottliebMichael, GriecoMichael, and SpeerMitchell (1988), AIDS/HIV Experimental Treatment Directory, New York: American Foundation for AIDS Research (AmFar).
2.
AltmanLawerence K. (1988a), “ED.A. Approves First Drug for an AIDS-Related Cancer,”The New York Times, 137 (November 22), C3.
3.
AltmanLawerence K. (1988b), “Mainstream Medicine Joins Growing Debate About Drug Approval,” The New York Times, 137 (December 6), C3.
4.
AIDS Treatment News (1987), “Public Policy Concerns—And Three Recommendations.”41 (September 25), 4–6.
5.
Barger-LuxM. Janet and HeaneyRobert P. (1986), “For Better and Worse: The Technological Imperative in Health Care,”Social Science and Medicine, 22 (12), 1313–20.
6.
BarinagaMarcia (1988), “Placebos Prompt New Protocols for AIDS Drug Test,” Nature, 335 (October 6), 485.
7.
BoffeyPhilip M. (1988), “Importing AIDS Drugs: Analysis of F.D.A. Policy,” The New York Times, 137 (July 26), C1, C6.
8.
BoothWilliam (1988), “AIDS Policy in the Making,” Science, 239 (March 4), 1087.
9.
Budget of the United States Government (1989a), House Document No. 101–3, 2–28.
10.
Budget of the United States Government (1989b), House Document No. 101–4 Appendix, I-K13.
11.
BurgerEdward J.Jr. (1988), “Scientific Information injudicial and Administrative Systems,”Social Science and Medicine, 27 (10), 1031–41.
12.
ChaseMarilyn (1986), “AIDS Research Stirs Bitter Fight Over Use of Experimental Drugs,” The Wall Street Journal, 210 (June 18), 29.
13.
ClarkMatt and HagerMary (1988), The Drug-Approval Dilemma: Does FDA Mean Foot-Dragging Administration?” Newsweek, 112 (November 14), 63.
14.
Des JarlaisDon C. and FriedmanSamuel R. (1988), “The Psychology of Preventing AIDS Among Intravenous Drug Users,”American Psychologist, 43 (November), 865–70.
15.
The Economist (1987a), “AIDS is Different: Desperate Diseases Justify the Risks of Desperate Remedies,”303 (June 20), 11.
16.
The Economist (1987b), “California Eases the Rules,”303 (October 3), 33.
17.
FDA Consumer (1987), “Fast-Tracking the First AIDS Drug,”21 (October), 13–15.
18.
The Federal Register (1987a), “New Drug, Antibiotic, and Biological Drug Product Regulations,” 52 (March 19), 8798–8847.
19.
The Federal Register (1987b), “Investigational New Drug, Antibiotic, and Biological Drug Product Regulations: Treatment Use and Sale,”52 (March 19), 8850–57.
20.
The Federal Register (1987c), “Investigational Drugs: Treatment Use and Sale,”52 (May 22), 19466–77.
21.
FergusonTom (1980), “Medical Self-Care: Self-Responsibility for Health,” in Health for the Whole Person, HastingsArthur C., FadimanJames F. and GordonJames S., eds., Boulder, CO: Westview, 87–99.
22.
FriersonJames G. (1985), “Public Policy Forecasting: A New Approach,”Advanced Management Journal, 50 (Spring), 18–23.
23.
FullertonRonald A. (1988), “How Modem is Modern Marketing? Marketing's Evolution and the Myth of the ‘Production Era’,”Journal of Marketing, 52 (January), 108–25.
24.
GouldStephen J. (1988), “Consumer Attitudes Toward Health and Health Care: A Differential Perspective,”Journal of Consumer Affairs, 22 (Summer), 96–118.
25.
GoyanJere E. (1988), “Drug Regulation: Quo Vadis,”Journal of the American Medical Association, 260 (November 25), 3052–53.
26.
GreenbergDaniel S. (1987), “The Government Bends to AIDS Victims’ Pleas,” U. S. News and World Report, 102 (March 23), 76.
27.
HammerJoshua (1988), “Inside the Illegal AIDS Drug Trade,”Newsweek, 112 (August 15), 41–42.
28.
HansanEbba H. and LaunsoLaila (1987), “Development, Use and Evaluation of Drugs: The Dominating Technology in the Health Care System,”Social Science and Medicine, 25 (1), 65–73.
29.
HarowskiKathy J. (1987), “The Worried Well: Maximizing Coping in the Face of AIDS,”Journal of Homosexuality, 14 (1,2), 299–306.
30.
HenigRobin M. (1986), “In Business to Treat Cancer,”The New York Times Magazine, 135 (November 23, 1986), 68–86.
31.
KaplanHoward B., JohnsonRobert J., BaileyCarol A. and SimonWilliam (1987), “The Sociological Study of AIDS: A Critical Review of the Literature and Suggested Research Agenda,”Journal of Health and Social Behavior, 28 (June), 140–57.
32.
KelleyHarold H. (1973), “The Processes of Causal Attribution,”American Psychologist, 28 (February), 221–34.
33.
KieslerCharles and MortonTeru L. (1988), “Psychology and Public Policy in the ‘Health Care Revolution’,”American Psychologist, 43 (December), 993–1003.
KolataGina (1988a), “Despite Promise in AIDS Cases, Drug Faces Testing Hurdle,” The New York Times, 137 (August 18), A1, B13.
36.
KolataGina (1988b), “Odd Alliance Would Speed New AIDS Drugs,” The New York Times, 137 (November 26), 9.
37.
KolataGina (1988c), “Recruiting Problems in New York Hinder U.S. Trials of AIDS Drug,” The New York Times, 137 (December 18), A1, A46.
38.
KolataGina (1989), “F.D. A. Said to be Re-Evaluating Order for More Studies on an AIDS Drug,” The New York Times, 138 (February), B8.
39.
KotlerPhilip and ClarkeRoberta N. (1987), Marketing for Health Care Organizations, Englewood Cliffs, NJ: Prentice-Hall.
40.
KrollRobert J. and StampflRonald W. (1986), “Orientations Toward Consumerism: A Test of a Two-Dimensional Theory,”Journal of Consumer Affairs, 20 (Winter), 214–30.
41.
KuhnThomas S. (1970), The Structure of Scientific Revolutions, Chicago: University of Chicago Press.
42.
MarwickCharles (1988), “FDA Seeks Swifter Approval of Drugs for Some Life-Threatening or Debilitating Diseases,” Journal of the American Medical Association, 260 (November 25), 2976.
43.
Medical World News (1987a), “Researchers Air AIDS Gripes,” 28 (September 28), 8–9.
44.
Medical World News (1987b), “State Speeds AIDS Drug Tests: California Drug-Testing Program Bypasses the FDA,” 28 (October 26), 20–21.
45.
Medical World News (1987c), “Community AIDS Research Lifts Off,” 28 (October 26), 21.
46.
MerzBeverly (1988), “Treatment INDs: Promising, Problematic,”Journal of the American Medical Association, 259 (March 18), 1607–1608.
47.
NeumannKarl (1987), “Should One Ever Suggest Alternative AIDS Treatments?” American Druggist, 196 (October), 48.
48.
North Jersey Community Research Initiative (No Date), A Community-Based Plan to Offer HIV Clinical Trials in Northern New Jersey, South Hackensack, NJ: New Jersey Community Research Initiative.
49.
ParsonsTalcott (1951), The Social System, New York: Free Press.
50.
PeltzmanSam (1974), Regulation and Pharmaceutical Innovation: The 1962 Amendment, Washington, D.C.: American Enterprise Institute.
51.
ReederLeo G. (1972), “The Patient-Client as a Consumer Some Observations on the Changing Professional-Client Relationship, Journal of Health and Social Behavior, 13 (December), 406–12.
52.
Science & Government Report (1988), “Q&A: NIH AIDS Chief Defends Research, Testing Strategy,”18 (September 15), 1, 3–6.
53.
SegalMarian (1987), “Defrauding the Desperate: Quackery and AIDS,”FDA Consumer, 21 (October), 17–19.
54.
SmithKevin and LongIris (1988), New York State AIDS Treatment Evaluation Units Progress Report, New York: ACT UP (AIDS Coalition to Unleash Power).
55.
SonnabendJoseph, NajmanRon, CallenMichael, and KrimMathilde (1986), “Community Research Initiative (CRI): A Proposal for the Prevention of AIDS,” (November 12), 1–11.
56.
StallRon D., CoatesThomas J., and HoffColleen (1988), “Behavioral Risk Reduction for HIV Infection Among Gay and Bisexual Men,”American Psychologist, 43 (November), 878–85.
57.
StatmanMeir and TyebjeeTyzoon T. (1981), “Trademarks, Patents, and Innovation in the Ethical Drug Industry,”Journal of Marketing, 45 (Summer), 71–81.
58.
StatmanMeir and TyebjeeTyzoon T. (1984), “Strategic Responses to Changes in Public Policy: The Case of the Pharmaceutical Industry and Drug Substitution Laws,”Journal of Public Policy and Marketing, 3, 99–112.
59.
TeminPeter (1979), “The Origin of Compulsory Drug Prescriptions,”The Journal of Law and Economics, 22 (April), 91–105.
60.
TurnerRalph H. and KillianLewis M. (1957), Collective Behavior, Englewood Cliffs, NJ: Prentice-Hall. WolfeSidney M., ColeyChristopher M., and the Health Research Group (1981), Washington, D.C.: Health Research Group.
61.
YoungFrank E., NorrisJohn A., LevittJoseph A., and NightengaleStuart L. (1988), “The FDA's New Procedures for the Use of Investigational Drugs in Treatment,”Journal of the American Medical Association, 259 (April 15), 2267–70.
