Love is not directed to abstractions but to persons; not to persons we do not know, nor to numbers of people, but to our own dear ones, our family and neighbors, ‘Our neighbor’, we remember, is one whom we live near, not locally perhaps, but in life and feeling.
Abstract
Biotechnological advance is speeding the development of drugs. The approval processes for new drugs will inevitably involve a regulatory agency in making political-economic and scientific choices. Interests of specific patients and the public in general are to be considered, and enormous stakes are involved for companies concerned. A medical regulatory authority must be at once insulated from and responsive to many different mixes of singular and general interests and pressures. Access to new drugs can be spurred by the press of patient advocacy groups, but if there are well organized groups to monitor the testing and approval process for such as AIDS or cancer drugs there is often no similar group to represent patient needs. If there is no organized patient advocacy group, compassionate responsibility by a medical regulatory authority is indeed called for. Delay in the approval of new drugs for fighting severe blood infections raises the question of how to insure the compassionate responsibility of a regulatory authority.
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Peirce, C. S. (1893/1935). Evolutionary love. In Hartshorne, C. & Weiss, P. (Eds.). (1935),Collected papers of Charles Sanders Peirce: Scientific metaphysics (Vol. VI). Cambridge, MA: Harvard University Press. Pp. 191–192.
Centers for Disease Control. (1990). Increase in national hospital discharge survey rates for septicemia — United States, 1979–1987.Morbidity & Mortality Weekly Report, 39: 31–34.
Bone, R. C., Fisher, C. J., Clemmer, T. P., et al., (1987). A controlled clinical trial of high-dose methylprednisolone in the treatment of severe sepsis and septic shock.New England Journal of Medicine 317: 653–658.
The Veterans Administration Systematic Sepsis Cooperative Study Group. (1987). Effect of high-dose glucocorticoid therapy on mortality in patients with clinical signs of systematic sepsis.New England Journal of Medicine, 317: 659–665.
Tate, S. J., Douglas, H., Braude, A. I., et al. (1966). Protection against lethality of “E. coli” endotoxin with “O” antiserum.Annals of the New York Academy of Sciences, 133: 746–762.
McCabe, W. R., Kreger, B. E., Johns, M., (1972). Type specific and cross-reactive antibodies in gram-negative bacteremia.New England Journal of Medicine, 287: 261–267.
Zeigler, E. J., McCutchan, J. A., Fierer, J., et al. (1982). Treatment of gram-negative bacteremia and shock with human antiserum to a mutant “Escherichia coli”.New England Journal of Medicine 307: 1225–1230.
Wolff, S. M. (1991). Monoclonal antibodies and the tratment of gram-negative bacteremia and shock.New England Journal of Medicine, 324: 486.
Ziegler, E. J., Fisher, C. J., Sprung, C., et al. (1991). Treatment of gram-negative bacteremia and septic shock with HA-1A human monoclonal antibody against endotoxin: A randomized, double-blind, placebo-controlled trial.New England Journal of Medicine, 324: 429–436.
Bone, R. C. (1991). Monoclonal antibodies to endotoxin; New allies against sepsis?Journal of the Americna Medical Association, 266: 1125.
Greenman, R. L., Schein, R. M. H., Martin, M. A., et al. (1991). A controlled clinical trial of E5 murine monoclonal IgM antibody to endotoxin in the treatment of gramnegative sepsis.Journal of the American Medical Association 266: 1097–1102.
Harkonen, S., Scannon, P., Mischak, R. P., et al. (1988). Phase I study of a murine monoclonal antilipid A antibody in bacteremic and nonbacteremic patients.Antimicrobial Agents & Chemotherapy, 32: 710–716.
Fisher, C. J., Zimmerman, J., Khazaeli, M. B., et al. (1990). Initial evaluation of human monoclonal antilipid A antibody (HA-1A) in patients with sepsis syndrome.Critical Care Medicine, 18: 1311–1315.
Gorelick, K. J., Jacobs, R. Chmel, H., et al. (1989). Efficacy results of a randomized multicenter trial of ES antiendotoxin monoclonal antibody in patients with suspected gram-negative sepsis.Abstracts of the 29th Interscience Conference on Antimicrobial Agents & Chemotherapy, 2.
Ziegler, E. J., Fisher, C. J., Sprung, C., et al. (1990). Prevention of death from gram-negative bacteremia and sepsis by HA-1A, a human monoclonal antibody specific for Lipid A of endotoxin: Results of phase III trial.Clinical Research, 38: 304A.
New York Times. (1991, March 15). Europe clears Centocor drug.New York Times, D3.
Pollack, A. (1991, September 5). Centocor's drug is ruled safe: F.D.A. panel deals a setback to Xoma.New York Times, D1 & D4.
Pear, R. (1990, August 16). Faster approval of AIDS drugs is urged. “Time is running out”, an advisory panel says.New York Times, B12.
National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS. (1990, August).Final report. Bethesda, MD: National Institutes of Health.
Kolata, G. (1990, October 21). A critique of pure reason, a passion to survive: Cheating on AIDS trials. Can desperately ill people be expected to feel a moral obligation to the demanding rigors of the scientific method?New York Times, E4.
Hilts, P. J. (1991, November 9). Proposal seeks to speed up Federal approval of drugs: A plan gives private groups the power to review drugs.New York Times, A10.
Leary, W. E. (1991, November 14). F.D.A. says it plants to quicken process for approving new drugs: “Millions of lives and billions of dollars”,New York Times, B14.
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Rosenberg, L.T. Delaying approval of a critical drug: Safety, efficacy, economics, compassion. J Med Hum 15, 243–250 (1994). https://doi.org/10.1007/BF02273711
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DOI: https://doi.org/10.1007/BF02273711