Education and Debate from the British Medical Journal:

• Mammography and the politics of randomised controlled trials
  "The purpose of screening mammography is to reduce mortality in women who develop breast cancer by detecting it at a stage when treatment is most likely to be effective.  Mammography has been more extensively evaluated by randomised controlled trials than any other screening intervention, but its effectiveness in some groups of women remains controversial..."
• Marketing medicines through randomised controlled trials: the case of interferon
  "Conducting randomised controlled trials involves establishing links and commitments between many different individuals and organisations, including clinicians, laboratory researchers, patients and their families, regulators, and drug companies..."
• "A calculated risk": the Salk polio vaccine field trials of 1954
  "Eighty-four test areas in 11 states used the textbook model: in a randomised, blinded design, all participating children in the first three grades of school (ages 6-9) received injections of either vaccine or placebo and were observed for evidence of the disease.  But 127 test areas in 33 states used an 'observed control' design: participating children in the second grade (ages 7-8) received injections of vaccine; no placebo was given, and children in all three grades were then observed for the duration of the polio 'season'..."

Patient Perspectives

• Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial
  "In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews were carried out with 20 participants from the CLasP randomised controlled trial. Interviews were recorded on audio tape and fully transcribed..."
• Distrust runs deep; medical community seeks solutions
  "Health experts worry that it is this deep-seated distrust of the medical establishment that keeps many African Americans from obtaining important preventive care and participating in clinical experiments designed to find out why blacks suffer disproportionately from several common diseases..." [Detroit News, December 10, 1995]
  Follow-up materials on the Tuskegee Study.
• System, race, and suspicion promote medical disparities
  "Health differences between African Americans and whites have deep historical roots in a health system that once systematically excluded blacks; in an economic structure that has provided better health care coverage and access to whites than blacks; and in a scientific community that until recently failed to research the special health needs of women and minorities..."
  Distrust and Bioethical Issues
• US compensates subjects of radiation experiments
  "The United States federal government has announced that it will pay $4.8m (£3.2m) in compensation to survivors of secret Cold War experiments sponsored by the government, in which patients were injected with radioactive isotopes without their consent..."

AZT Therapy to Prevent Perinatal Transmission of HIV

• The Debate Over Clinical Trials of AZT to Prevent Mother-to-Infant Transmission of HIV in Developing Nations
  An on-line interactive case study developed by by the Case Program, John F. Kennedy School of Government, Harvard University. For program participants only.
• CDC, NIH halt controversial use of placebos in AZT trials
  "U.S. government agencies sponsoring clinical trials in developing countries to test approaches to reduce mother-to-child HIV transmission have asked investigators to drop the studies’ controversial placebo arms. The National Institutes of Health and the Centers for Disease Control and Prevention made the recommendation after findings from a Thailand trial showed a shortened regimen of the drug AZT appears to lower vertical transmission."
  Playing the Tuskegee Card in International AIDS research
• NEJM: Ethical Issues in Studies in Thailand of the Vertical Transmission of HIV [NEJM 1998;338:834-835 (March 19)]
  "I believe that placebo-controlled trials are sometimes justified in countries where treatment is otherwise totally unavailable, because at least half the patients (those receiving active treatment) will probably benefit. This is particularly true if the trial will generate results that will directly benefit the patient population under study. But the availability of resources is usually relative..."
  Science and Social Conscience: Praphan Phanuphak, MD, PhD, Discusses AIDS in Thailand
• NEJM Sounding Board: Ethical Complexities of Conducting Research in Developing Countries
  Harold Varmus and David Satcher NEJM 1997;337(14):1003-1005 (October 2)
  "Trials that make use of impoverished populations to test drugs for use solely in developed countries violate our most basic understanding of ethical behavior. Trials that apply scientific knowledge to interventions that can be used to benefit such populations are appropriate but present their own ethical challenges. How do we balance the ethical premises on which our work is based with the calls for public health partnerships from our colleagues in developing countries?"
  The Ethics of Clinical Research in the Third World NEJM 1997;337(12):847-849 (September 18) - Marcia Angell