Skip to main content

Clinical Trials and the Collective Ethic: The Case of Hyperbaric Oxygen Therapy and the Treatment of Multiple Sclerosis

  • Chapter
Social Science Perspectives on Medical Ethics

Part of the book series: Culture, Illness, and Healing ((CIHE,volume 16))

Abstract

The ethical basis of medical experimentation on human subjects is an issue at the core of bioethics. In such experimentation the balance between individual and collective rights, and in particular the balance between physicians’ therapeutic obligation to their patients — the individual ethic (Clayton 1982), and their duty to further scientific knowledge for the collective good — the collective ethic (Lellouch and Schwartz 1971), has become an issue of major importance. Much of the debate about this issue has now been focused on the ethical status and role of the clinical trial in modern scientific medicine.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 169.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 219.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  • Armitage, P. 1982 The Role of Randomisation in Clinical Trials Statistics. Medicine 1: 345–352.

    Google Scholar 

  • ARMS 1989 Handbook of arms Therapy Centres. Stansted, UK: Action for Research into Multiple Sclerosis.

    Google Scholar 

  • Arpillange, P. and Dion, S. 1986 The Ethical Approach to Randomisation in Oncology Drugs. Experimental Clinical Research 12: 99–103.

    Google Scholar 

  • Barber, B. 1981 Biomedical Research as a Social Process. In Wechsler, H., Lamont-Havers, R.W. and Cahill, G.F. (eds.) The Social Context of Medical Research. Cambridge, Mass.: Ballinger. Pp. 127–142.

    Google Scholar 

  • Barnes, J.A. 1979 Who Should Know What? Social Science, Privacy and Ethics. Harmondsworth: Penguin.

    Google Scholar 

  • Barnes, M.P. et al. 1985 Hyperbaric Oxygen and Multiple Sclerosis: Short Term Results of a Placebo-Controlled Double Blind Trial. Lancet 1: 297–300.

    Article  Google Scholar 

  • Barnes, M.P. et al. 1987 Hyperbaric Oxygen and Multiple Sclerosis: Final Results of a Placebo-Controlled, Double Blind Trial. Journal of Neurology, Neurosurgery and Psychiatary 50: 1402–1406.

    Article  Google Scholar 

  • Bates, D. 1986 Hyperbaric Oxygen Therapy in Multiple Sclerosis. Journal of the Royal Society of Medicine 79: 535–537.

    Google Scholar 

  • Baum, M. 1982 The Ethics of Clinical Trials and Informed Consent. Experientia (supplement). 41: 300–308.

    Google Scholar 

  • Baum, M. 1983 Commentary. Journal of Medical Ethics 9: 92–93.

    Google Scholar 

  • Baum, M. 1986 Do We Need Informed Consent? Lancet 2: 911–912.

    Article  Google Scholar 

  • Behnke, A.R. 1977 A Brief History of Hyperbaric Medicine. In Davis, J.C. and Hunt, T.K. (eds.) Hyperbaric Oxygen Therapy. Bethesda: Undersea Medical Society. Pp. 3–10.

    Google Scholar 

  • Berlant, J.L. 1975 Profession and Monopoly. Berkeley: University of California Press.

    Google Scholar 

  • Boschetty, V. and Cernoch, J. 1970 Aplikace Kysliku za Pretlaku Nekterych Neurologickych Anemocneni. Bratislav Lek Lesty 53: 298–302.

    Google Scholar 

  • Burkhardt, R. and Kienle, G. 1983 The Practical and Ethical Defects of Surgical Randomised Prospective Trials. Journal of Medical Ethics 9: 90–92.

    Article  Google Scholar 

  • Chalmers, T.C. 1982 Randomised Clinical Trials and the Consumers. In Tygstrup, N., Lachin, J.M. and Juhl, E. (eds.) The Randomised Clinical Trial and Therapeutic Decisions. New York: Marcel Dekker. Pp. 257–263.

    Google Scholar 

  • Clayton, D. 1982 Ethically Optimised Designs. British Journal of Clinical Pharmacology 13: 469–480.

    Google Scholar 

  • Cochrane, A.L. 1972 Effectiveness and Efficiency: Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust.

    Google Scholar 

  • Confavreux, C. et al. 1986 Hyperbaric Oxygen Therapy in Multiple Sclerosis: A Double-Blind Randomised Placebo-Controlled Study. Presse Médicale 15: 1319–1322.

    Google Scholar 

  • Davidson, D.L.W. 1983 Hyperbaric Oxygen Therapy in the Treatment of Multiple Sclerosis. Stansted, UK: Action for Research into Multiple Sclerosis Education Service.

    Google Scholar 

  • Ditchley Foundation Report 1980 The Scientific and Ethical Basis of the Clinical Evaluation of Medicines. European Journal of Clinical Pharmacology 18: 129–134.

    Article  Google Scholar 

  • Fischer, B.H., Marks, M. and Reich, T. 1983 Hyperbaric Oxygen Treatment of Multiple Sclerosis. The New England Journal of Medicine 308: 181–186.

    Article  Google Scholar 

  • Freidson, E. 1970 Profession of Medicine: A Study of the Sociology of Applied Knowledge. New York: Dodds Mead.

    Google Scholar 

  • Friedman, L.M., Furberg, CD. and De Mets, D.L. 1980 Fundamentals of Clinical Trials. Boston: John Wright.

    Google Scholar 

  • Gifford, F. 1986 The Conflict Between Randomised Clinical Trials and the Therapeutic Obligation. Journal of Medicine and Philosophy 11: 347–366.

    Google Scholar 

  • Gilmour, D. 1977 Psychological Factors in Clinical Trials. In Johnson, F.N. and Johnson, S. (eds.) Clinical Trials. Oxford: Blackwell. Pp. 147–161.

    Google Scholar 

  • Greer, S. 1984 The Psychological Dimension in Cancer Treatment. Social Science and Medicine 18: 345–349.

    Article  Google Scholar 

  • Gritzer, B. and Arluke, A. 1985 The Making of Rehabilitation. Berkeley: University of California Press.

    Google Scholar 

  • Hansen, E.H. and Launso, L. 1987a Clinical Trials: Towards a Different Model. Journal de pharmacie clinique 6: 67–74.

    Google Scholar 

  • Hansen, E.H. and Launso, L. 1987b Development, Use and Evaluation of Drugs: The Dominating Technology in the Health Care System. Social Science and Medicine 25: 65–73.

    Article  Google Scholar 

  • Hansen, E.H. and Launso, L. 1988 Is the Controlled Clinical Trial Sufficient as a Drug Technology Assessment? Working Paper, Royal Danish School of Pharmacy, Copenhagen.

    Google Scholar 

  • Harpur, G.D. 1986 Hyperbaric Oxygen Therapy in Chronic Stable Multiple Sclerosis: Doubleblind Study. Neurology 36: 988–991.

    Google Scholar 

  • Hasskarl, H.W. 1981 Legal Problems of Controlled Clinical Trials. Controlled Clinical Trials 1: 401–409.

    Article  Google Scholar 

  • Hunt, S., McEwan, J. and McKenna, S.P. 1986 Measuring Health Status. London: Croom Helm.

    Google Scholar 

  • Ingelfinger, F.J. 1982 Randomised Controlled Trials and the Public. In Tygstrup, N., Lachin, J.M. and Juhl, E. (eds.) The Randomised Clinical Trial and Therapeutic Decisions. New York: Marcel Dekker. Pp. 277–281.

    Google Scholar 

  • International Federation of Multiple Sclerosis Societies 1982 Therapeutic Claims in Multiple Sclerosis. New York: International Federation of Multiple Sclerosis Societies.

    Google Scholar 

  • Jacobson, J.H., Morsch, J.H.C. and Rendall-Baker, L. 1965 The Historical Perspective on Hyperbaric Oxygen. Annals of the New York Academy of Sciences 117: 651–670.

    Google Scholar 

  • James, P.B. 1982 Evidence for Sub-acute Fat Embolism as a Cause of Multiple Sclerosis. Lancet 1: 380–386.

    Article  Google Scholar 

  • Johnson, F.N. and Johnson, S. (eds.) 1977 Clinical Trials. Oxford: Blackwell.

    Google Scholar 

  • Journal of Medical Ethics (Editorial) 1982 Research, Consent, Distress and Truth. Journal of Medical Ethics 8: 59–60.

    Article  Google Scholar 

  • Kadane, J.B. 1986 Progress Towards a More Ethical Method for Clinical Trials. Journal of Medicine and Philosophy 11: 385–404.

    Google Scholar 

  • Kennedy, T.J. and Bennett, I.L. 1981 The Planning of Research: The Role of the Federal Government. In Wechsler, H., Lamont-Havers, R.W. and Cahill, G.F. (eds.) The Social Context of Medical Research. Cambridge, Mass.: Ballinger. Pp. 27–72

    Google Scholar 

  • Kirby, M.D. 1983 Informed Consent: What Does it Mean? Journal of Medical Ethics 9: 69–75.

    Article  Google Scholar 

  • Kopelman, L. 1986 Consent and Randomised Clinical Trials: Are there Moral or Design Problems? Journal of Medicine and Philosophy 11: 317–346.

    Google Scholar 

  • Lancet (Editorial) 1984 Consent: How Informed? Lancet 1: 1445–1447.

    Google Scholar 

  • Lellouch, J. and Schwartz, D. 1971 L’essai thérapeutique: éthique individuelle ou éthique collective? Revue de l’Institut International de Statistique 39: 127–136.

    Article  Google Scholar 

  • Levine, R.J. 1987 The Apparent Incompatibility Between Informed Consent and Placebo-Controlled Clinical Trials. Clinical Pharmacology and Therapeutics 42: 247–256.

    Article  Google Scholar 

  • Lhermitte, F. et al. 1986 Double Blind Treatment of Chronic Multiple Sclerosis Using Hyperbaric Oxygen. Revue Neurologique 142: 201–206.

    Google Scholar 

  • Macara, A.W. 1986 Informed Consent. Lancet 2: 1101.

    Google Scholar 

  • McEwen, J., Martini, C.J.M. and Wilkins, N. 1983 Participation in Health. London: Croom Helm.

    Google Scholar 

  • Marquis, D. 1986 An Argument That All Prerandomised Clinical Trials are Unethical. Journal of Medicine and Philosophy 11: 367–383.

    Google Scholar 

  • Matthews, W.B. et al. 1985 McAlpine’s Multiple Sclerosis. Edinburgh: Churchill Livingstone.

    Google Scholar 

  • Medical Research Council. 1948 Streptomycin Treatment of Pulmonary Tuberculosis. British Medical Journal 2: 769–782.

    Article  Google Scholar 

  • Meir, P. 1979 Terminating a Trial: The Ethical Problem. Clinical Pharmacology and Therapeutics 25: 633–640.

    Google Scholar 

  • Moser, M. 1986 Randomised Clinical Trials: Problems and Values. American Journal of Emergency Medicine 4: 173–178.

    Google Scholar 

  • Neubauer, R.A., Schnell, R. and Goldberg, G.S. 1979 Treatment of Multiple Sclerosis with Monoplace Hyperbaric Oxygenation. Paper presented to the 4th Conference on the Clinical Application of Hyperbaric Oxygen, Long Beach.

    Google Scholar 

  • Neubauer, R.A. 1980 Exposure of Multiple Sclerosis Patients to Hyperbaric Oxygen at 1.5–2 A.T.A. Journal of the Florida Medical Association 67: 498–504.

    Google Scholar 

  • Neubauer, R.A. 1983 Hyperbaric Oxygen Therapy of Multiple Sclerosis. Fort Lauderdale: Ocean Medical Center.

    Google Scholar 

  • Nicholson, M. and McLaughlin, C. 1988 Social Constructionism and Medical Sociology: A Study of the Vascular Theory of Multiple Sclerosis. Sociology of Health and Illness 10: 234–261.

    Article  Google Scholar 

  • Prout, T.E. 1981 The Ethics of Informed Consent. Controlled Clinical Trials 1: 429–434.

    Article  Google Scholar 

  • Robinson, D. and Henry, S. 1977 Self-Help and Health. London: Martin Robertson

    Google Scholar 

  • Robinson, I. 1987 Analysing the Structure of 23 Clinical Trials in Multiple Sclerosis. Neuroepidemiology 6: 46–76.

    Article  Google Scholar 

  • Robinson, I. 1988 Multiple Sclerosis. London: Tavistock.

    Google Scholar 

  • Schaffner, K.F. 1986 Ethical Problems in Clinical Trials. Journal of Medicine and Philosophy 11: 297–316.

    Google Scholar 

  • Silberberg, D.H. 1984 Problems in Evaluating New Treatments for Multiple Sclerosis. Annals of the New York Academy of Sciences 436: 418–422.

    Article  Google Scholar 

  • Simnett, J.D. 1982 We Need to Take a Fresh Look at Medical Research. Journal of Medical Ethics 8: 73–77.

    Article  Google Scholar 

  • Spodick, D.H. 1982 The Randomised Controlled Clinical Trial: Scientific and Ethical Bases. American Journal of Medicine 73: 420–425.

    Article  Google Scholar 

  • Teeling-Smith, G. (ed.) 1987 Measuring Health Status. London: Wiley.

    Google Scholar 

  • Van Eys, J. 1982 Clinical Research and Clinical Care: Ethical Problems in the “War on Cancer.” American Journal of Pediatric Hematology and Oncology 4: 419–423.

    Article  Google Scholar 

  • Vere, D.W. 1983 Problems in Controlled Trials: A Critical Response. Journal of Medical Ethics 9: 85–89.

    Article  Google Scholar 

  • Von Eickstedt, K.W. 1983 The Ethical Position of the Attending Physician in Phase 3 of Clinical Investigations. International Journal of Pharmacology, Therapeutics and Toxicology 21: 529–533.

    Google Scholar 

  • Waldenstrom, J. 1983 The Ethics of Randomisation. Progress in Clinical and Biological Research 128: 243–249.

    Google Scholar 

  • Webster, C. et al. 1988 Longterm Hyperbaric Oxygen Therapy for Multiple Sclerosis. Stansted, UK: Action for Research into Multiple Sclerosis.

    Google Scholar 

  • Wiles, C.M. et al. 1986 Hyperbaric Oxygen in Multiple Sclerosis: A Double Blind Trial. British Medical Journal 292: 367–371.

    Article  Google Scholar 

  • Worthington, J.A. et al. 1987 A Double Blind Crossover Trial Investigating the Efficacy of Hyperbaric Oxygen in Patients with Multiple Sclerosis. In Clifford, Rose F. and Jones, R. (eds.) Multiple Sclerosis: Immunological, Diagnostic and Therapeutic Aspects. London: J. Libbey.

    Google Scholar 

Download references

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 1990 Kluwer Academic Publishers

About this chapter

Cite this chapter

Robinson, I. (1990). Clinical Trials and the Collective Ethic: The Case of Hyperbaric Oxygen Therapy and the Treatment of Multiple Sclerosis. In: Weisz, G. (eds) Social Science Perspectives on Medical Ethics. Culture, Illness, and Healing, vol 16. Springer, Dordrecht. https://doi.org/10.1007/978-94-009-1930-3_2

Download citation

  • DOI: https://doi.org/10.1007/978-94-009-1930-3_2

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-7361-5

  • Online ISBN: 978-94-009-1930-3

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics