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Legal Issues in Alzheimer Disease Research in France

  • Alain Garay
Part of the Advances in Alzheimer Disease Therapy book series (AADT)

Abstract

Therapy testing on man is as old as medicine itself. In honor of this, Article 15 of the Code of Medical Ethics, in no uncertain terms, requires doctors to “ensure the regularity of… biomedical research.” Alzheimer’s disease, a form of senile dementia and a biological enigma affecting more than 400,000 persons in France, remains a challenge to experimental medicine (LaRevue du Practicien, 1995). For French specialists, neurologists and gerontologists, THA (Tetrahydroaminoacrinine or tacrine) appeared to be a possible therapy, leading to an administrative marketing permit in April, 1994 (La Presse médicale, 1995). At present, the “best candidates” for tacrine are notably “those who are in a position to be included in research protocols for more efficient and tolerated medicine” (Derouesne, (1994); LaRevue du Practicien, 1994).

Keywords

Senile Dementia Market Permit Minimal Importance Voluntary Consent Uncertain Term 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. Article L 209–9 (1988): Before proceeding with any research on human beings, all investigators are obligated to submit a project to this committee. In: Conditions of Consent, December 20.Google Scholar
  2. Assemblée Nationale (Charles M): This analysis is based on the interpretation of the law of the House of Representatives according to whom the law embraces “research (diagnostic, therapeutic and preventative research) including the examination of medical substances, as well as research linked with all new surgical technics”.Google Scholar
  3. Beaudoin J-L and Parizeau M-H (1987): Legal and Ethic Reflections Concerning Consent to Medical Treatment, Medicine-Science 3: 8–12.Google Scholar
  4. Bick C (1983): Concerning European case law. Medical Research and Human Rights, the European approach. JPC 1:3719.Google Scholar
  5. Bouvenet G, and Eschwege E (1994): Therapy Testing and Informed Consent - Methodological Bases, Legal and Ethical Aspects. La Revue du Practicien Vol. 44:2767–9.Google Scholar
  6. Bouvier F (1986): An opinion relating to “Ethical Problems Raised by the Testing of New Treatments on Men” In: Consent to Therapy: Realities and Perspectives, J C P 1:3249.Google Scholar
  7. Code of Public Health (1990): The application decree N° 90–872 dated September 27, 1990, introduced in the regulations section a book II b entitled “Protection of Individuals Volunteering for Biomedical Research”.Google Scholar
  8. COGNEXTM (1994): This document signed on September 9, 1994 by the directors of social security of hospitals and health, outlines the mode of prescriptions and the pharmacological oversight of COGNEX, one of the first medicines with a degree of efficiency in treating Alzheimer’s disease.Google Scholar
  9. Commission, (1979): X versus Austria. December 13, N° 8278–78.Google Scholar
  10. Derouesne C, (1994): Which kind of patients with Alzheimer’s disease can be treated and how? Reply to V. Lemaire’s note In: Le Concours Médical, September 17, pp. 2392–2393.Google Scholar
  11. Duprat J-P (1982): Information and Consent of the Patient in the Case of Tests of Medicine on Humans. RTDSS:369. Google Scholar
  12. European Convention of Human Rights Commission (1983): establishes the prohibition to submitting of an individual to inhumane or degrading treatment. Article 3 March 2, N° 9974/82: D.R. 32:292.Google Scholar
  13. Fagot-Largeault A (1994): Informed Consent, Medicine and Law, N° 6, May-June, pp. 55–56.Google Scholar
  14. Jasmin C (1991): Bioethics and Therapeutic Research: Informed Consent, Médecine-Science May, N°5, Vol.7: p. 473.Google Scholar
  15. La Documentationfrançaise (1988): Documentary notes and studies. -5, N°.4855:23.Google Scholar
  16. La Presse médicale (1995): This substance, commercialized under the tradename COGNEX was previously only available in the United States. February 4, N° 5, pp. 285.Google Scholar
  17. La Revue du Practicien (1994): Coverage Forms for Alzheimer’s Patients. September 26, pp. 17–20.Google Scholar
  18. La Revue du Practicien (1995): This neurological degenerative complaint is characterized notably by the appearance of problems of memory, personality and language. December 18, pp. 7–70.Google Scholar
  19. Labbée X (1995): Medical Experimentation,Médecine et Droit N° 11:10–15.CrossRefGoogle Scholar
  20. Litec (1993): Biomedical Research on Man: Medical and Hospital-Related Law. 5-, Fasc. 34:3.Google Scholar
  21. Maurain C and Viala G (1985): On the difficulty of a right to therapeutic information: Legal Limits of Therapeutic Information. JPC I:3203.Google Scholar
  22. Montador J (1971): The absence of Consent and Hospital Public Service’s Responsibility, RTDSS: 180–191.Google Scholar
  23. Nuremberg Code (1949):.”It is absolutely necessary to obtain the voluntary consent of the patient…For the duration of the tests, the volunteer patient will have the right to decide to stop the tests if these cause him mental or physical discomfort and if, in any other manner, the continuation of the tests seems impossible to him”. In: United States vs Karl Brandt et al. Google Scholar
  24. Parizeau M H (1988): Randomization, double blinds, placebos or reference medicine In: The Concept of Consent to Human Experimentation, doctorate of philosophy thesis, University Paris XIIGoogle Scholar
  25. Roy D J (1986): Medical and Research Practices; North-American Perspectives on Consent. Medicine and Hygiene 44:2014–2017.Google Scholar
  26. Sabatini J (1990): From Absence of Consent to Tape of a Person. Rev Prat. 40:935–936.PubMedGoogle Scholar
  27. Thouvenin D (1985): Human Experimentation: on the Concept of Informed Consent, Technical Culture, November, N° 15:109.Google Scholar
  28. Thouvenin D (1988): The Reference to the Care Contract in Experimentation on Humans, In: Medical Ethics and Human Rights, Actes Sud-Inserm: 123–146.Google Scholar
  29. Woodward W (1979): Informed consent of volunteers: a direct measurement of comprehension and retention of information, Clinical research 27:248.PubMedGoogle Scholar

Copyright information

© Birkhäuser Boston 1997

Authors and Affiliations

  • Alain Garay
    • 1
  1. 1.ParisFrance

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