The Hazards of Misguided Compassion
Authors: Paul D. Stolley
Journal: Annals of Internal Medicine (1993)

Editorials15 May 1993The Hazards of Misguided CompassionPaul D. Stolley, MDPaul D. Stolley, MDUniversity of Maryland School of Medicine, Baltimore, MD 21201.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-118-10-199305150-00011 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The plight of patients with human immunodeficiency virus (HIV) infection is heart-rending, and so the patients, their families, and doctors want to be free of restrictions on the availability of drugs. Compassion combined with lobbying has led to exemptions from the usual way of evaluating the safety and efficacy of new treatments, so that drugs to treat HIV infection are available outside of randomized trials, and treatment decisions must be based on smaller randomized trials, which lack statistical power, and on nonrandom trials that may be biased. Through misguided compassion, the medical community may never learn enough about new drugs ...References1. Byar DP, Schoenfeld DA, Green SB, et al. Design considerations for AIDS trials. N Engl J Med. 1990; 323:1343-8. Google Scholar2. Edgar H, Rothman DJ. New rules for new drugs: the challenge of AIDS to the regulatory process. Milbank Q. 1990; 68(Suppl 1):111-42. Google Scholar3. Fischl MA, Olson RM, Follansbee SE, Lalezari JP, Henry DH, Frame PT, et al. Zalcitabine compared with zidovudine in patients with advanced HIV-1 infection who received previous zidovudine therapy. Ann Intern Med. 1993; 118:762-6. Google Scholar4. Sergios PA. One Boy at War: My Life in the AIDS Underground. New York: Knopf; 1993. Google Scholar5. Kwitny J. Acceptable Risks. New York: Poseidon Press; 1992. Google Scholar6. Austin SC, Stolley PD, Tasky T. The history of malariotherapy for neurosyphilis. JAMA. 1992; 268:516-9. Google Scholar7. Stolley PD, Lasky T. Shortcuts in drug evaluation. Clin Pharmacol Ther. 1992; 52:1-3. Google Scholar Author, Article, and Disclosure InformationAuthors: Paul D. Stolley, MDAffiliations: University of Maryland School of Medicine, Baltimore, MD 21201.Corresponding Author: Paul D. Stolley, MD, Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, 660 West Redwood Street, Baltimore, MD 21201. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoZalcitabine Compared with Zidovudine in Patients with Advanced HIV-1 Infection Who Received Previous Zidovudine Therapy Margaret A. Fischl , Richard M. Olson , Stephen E. Follansbee , Jacob P. Lalezari , David H. Henry , Peter T. Frame , Scot C. Remick , Miklos P. Salgo , Amy H. Lin , Cheryl Nauss-Karol , Judith Lieberman , and Whaijen Soo* Metrics Cited byEthics in the Time of Coronavirus: Recommendations in the COVID-19 PandemicShould We Embrace New Drugs with Open Arms? Experience from a Community-Based, Open-Arm, Randomized Clinical Trial of Combination Antiretroviral Therapy in Advanced HIV DiseaseAcademic Nihilism 15 May 1993Volume 118, Issue 10Page: 822-823KeywordsAIDSDrug policyDrug safetyDrug therapyDrugsHIVHIV infectionsRandomized trialsSafetySexually transmitted diseases ePublished: 15 August 2000 Issue Published: 15 May 1993 Copyright & PermissionsCopyright © 1993 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...