Don't test, do sell: Legal implications of inclusion and exclusion of women in clinical drug trials

Epilepsia

Volumn 38, Issue SUPPL. 4, 1997, Pages

  Herz, Susan E ^a,b  

^a SUFFOLK UNIVERSITY   (United States)

^b NONE   (United States)

Author keywords

Clinical trials; Drug approval; Drug evaluation; Drug protocols; Investigational drugs; Legal liability; Women

Indexed keywords

DRUG;

ARTICLE; CLINICAL TRIAL; DRUG RESEARCH; DRUG SCREENING; FEMALE; HEALTH CARE POLICY; HUMAN; LEGAL LIABILITY; MALE; MEDICOLEGAL ASPECT; PRIORITY JOURNAL; SEX DIFFERENCE;

EID: 0030754033     PISSN: 00139580     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1528-1157.1997.tb04538.x     Document Type: Article

References (22)

1. Dresser R. Wanted: single, white female for medical research. Hastings Center Rep 1992;22:24-9.
2. Merton V. Ethical obstacles to the participation of women in biomedical research. In: Wolf S, ed. Feminism and bioethics. New York: Oxford University Press, 1996:217-51.
3. Hamilton J. Women and health policy: on the inclusion of females in clinical trials. In: Sargent C, Brettell C, eds. Gender and health. Englewood, NJ: Prentice-Hall, 1996:292-325.
4. Hauser WA, Hesdorffer DC. Epilepsy: frequency, causes and consequences. New York: Demos Publications, 1990.
5. Kurtz Z. Sex differences in epilepsy: epidemiological aspects. In: Trimble M, ed. Women and epilepsy. Chichester, UK: John Wiley & Sons, 1991:47-63.
6. Morrell MJ. Maximizing the health of women with epilepsy: science and ethics in new drug development. Epilepsia 1997;38(suppl 4):S32-41 (this issue).
7. Hamilton J. Avoiding methodological and policy-making biases in gender-related research. In: US Superintendent of Documents. Report of the public health service task force on women's health issues. Vol. II. Washington, DC: US Government Printing Office 1985:54-64.
8. Institute of Medicine (IOM). Women and health research: ethical and legal issues of including women in clinical studies. Washington DC: National Academy Press, 1994.
9. Iso H, Jacobs DR, Wentworth D, Neaton JD, Cohen JD. Serum cholesterol levels and six-year mortality from stroke in 350,977 men screened for the multiple risk factor trial. N Engl J Med 1989;320:904-9.
10. Steering Committee of the Physician's Health Study Group. Final report on the aspirin component of the ongoing physician's health study. N Engl J Med 1989;321:129-35.
11. NIH Revitalization Act of 1993. 42 USC 289A.
12. Healy B. The Yentl Syndrome. N Engl J Med 1991;325:274-6. FDA (Food and Drug Administration).
13. Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. Notice. Fed Reg 1993;58:39406-16.
14. Merkatz E et al. Women in clinical trials of new drugs: a change in FDA policy. N Engl J Med 1993;329:292-6.
15. Hamilton J. Feminist theory and health psychology: tools for an egalitarian, woman-centered approach to women's health, J Womens Health 1993;2:49-54.
16. Bennett C. Inclusion of women in clinical trial policies for population subgroups. N Engl J Med 1993;329:288-92.
17. Anastos K, Charney P, Charon RA, et al. Hypertension in women: what is really known? Ann Intern Med 1991;115:287-93.
18. Oberman M. Real and perceived barriers to the inclusion of women in clinical trials. In: Dan A, ed. Reframing womens health. Thousand Oaks, CA: Sage, 1994:266-76.
19. Council on Ethical and Judicial Affairs. Gender disparities in clinical decision making. JAMA 1991;266:559-62.
20. International Union, UAW v. Johnson Controls, 111 S. Ct., 1991:1196.
21. American Law Institute. Restatement (Second) of Torts. Section 402A, 1977.
22. Merton V. The exclusion of pregnant, pregnable, and once pregnable people (a/k/a women) from biomedical research. Am J Law Med 1993;19:369-451.