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December 22, 1993, Vol 270, No. 24 >
ARTICLE | December 22, 1993

National Policy Development for the Clinical Application of Genetic Diagnostic Technologies: Title and subTitle BreakLessons From Cystic Fibrosis FREE

Benjamin S. Wilfond, MD; Kathleen Nolan, MD, MSL
[+] Author Affiliations

Reprint requests to Department of Pediatrics, University of Arizona Health Sciences Center, 1501 N Campbell Ave, Tucson, AZ 85724 (Dr Wilfond).


JAMA. 1993;270(24):2948-2954. doi:10.1001/jama.1993.03510240060033
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Published online
Article
References

In recognition of the earlier experiences with genetic diagnostic services and in anticipation of a greater potential for genetic testing for presymptomatic disease and disease susceptibility, this article provides an analysis of policy development for cystic fibrosis carrier screening. The deficiencies of relying on an extemporaneous model for health policy development are described. Preferably, an evidentiary model, based on the evaluation of clinical research and incorporating professional and public attention to underlying normative issues, should define the standard of care. Appropriate procedural mechanisms should be established at both state and federal levels to prevent the unnecessary confusion, expense, and personal or social harms likely to result from a completely unrestrained application of developing genetic technologies or continuing ad hoc responses to rapid increases in genetic diagnostic capabilities. A broadly constituted national advisory commission on the ethical, legal, and social implications of the Human Genome Project would provide an important locus for national decision making and may offer an efficient mechanism for implementing the evidentiary model, promoting public involvement at a time when social policy decisions must be made to restructure the health care system to be more sensitive to issues of access, allocation, and costs.

(JAMA. 1993;270:2948-2954)

REFERENCES

1 +
Caskey CT.  Molecular medicine: a spin-off from the helix. JAMA . 1993;;269:1986-1992.
2 +
Holtzman NA.  The diffusion of new genetic tests for predicting disease. FASEB J . 1992;;6:2806-2812.
3 +
Fearon ER, Jones PA.  Progessing toward a molecular description of colorectal cancer development. FASEB J . 1992;;6:2783-2790.
4 +
Biesecker BB, Boehnke M, Calzone K, et al.  Genetic counseling for families with inherited susceptability to breast and ovarian cancer. JAMA . 1993;; 269:1970-1974.
5 +
MacCluer JW, Kammerer CM.  Dissecting the genetic contribution to coronary heart disease. Am J Hum Genet . 1991;;49:1139-1144.
6 +
Corder EH, Saunders AM, Strittmatter WJ, et al.  Gene dose of apolipoprotein E type 4 allele and the risks of Alzheimer's disease in late onset families. Science . 1993;;261:921-923.
7 +
Nolan K.  First fruits: genetic screening. Hastings Cent Rep . 1992;;22, (No. (4) special suppl):S2-S4.
8 +
Wilfond BS, Fost N.  The introduction of cystic fibrosis carrier screening into clinical practice: policy considerations. Milbank Q . 1992;;70:629-659.
9 +
Lappé M, Gustafson J, Roblin R.  Ethical and social issues in screening for genetic disease. N Engl J Med . 1972;;286:1129-1132.
10 +
Committee on Inborn Errors of Metabolism. Genetic Screening: Programs, Principles, and Research . Washington, DC: National Academy of Sciences; 1975;.
11 +
Screening and Counseling for Genetic Conditions: The Ethical, Social, and Legal Implications of Genetic Screening, Counseling, and Education Programs . Washington, DC: President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research; 1983;.
12 +
Levine C, Dubler NN.  Uncertain risks and bitter realities: the reproductive choices of HIV-infected women. Milbank Q . 1990;;68:321-351.
13 +
Billings PR, Kohn MA, de Cuevas M, Beckwith J, Alper JS, Natowicz MR.  Discrimination as a consequence of genetic testing. Am J Hum Genet . 1992;;50:476-482.
14 +
Holtzman NA, Rothstein MA.  Eugenics and genetic discrimination. Am J Hum Genet . 1992;;50: 457-459.
15 +
Wiggins S, Whyte P, Huggins M, et al.  The psychological consequences of predictive testing for Huntington's disease. N Engl J Med . 1992;;327: 1401-1405.
16 +
Ostrer H, Allen W, Crandall LA, et al.  Insurance and genetic testing: where are we now? Am J Hum Genet . 1993;;52:565-577.
17 +
Reilly P. Genetics, Law, and Social Policy . Cambridge, Mass: Harvard University Press; 1977;.
18 +
Bessman SP, Swazey JP.  PKU: a study of biomedical legislation.  In: Mendelsohn E, Swazey JP, Taviss I, eds. Human Aspects of Biomedical Innovation . Cambridge, Mass: Harvard University Press; 1971;:49-76.
19 +
American Academy of Pediatrics.  Statement on compulsory testing of newborn infants for hereditary metabolic disorders. Pediatrics . 1967;;39: 623.
20 +
Elias S, Annas GJ, Simpson JL.  Carrier screening for cystic fibrosis: a case study in setting standards of medical practice.  In: Annas GJ, Elias S, eds. Gene Mapping: Using Law and Ethics as Guides . New York, NY: Oxford University Press; 1992;:186-202.
21 +
Moertel CG,Fleming TR,MacDonald JS, Haller DG, Laurie JA, Tangen C.  An evaluation of the carcinoembryonic antigen (CEA) test for monitoring patients with resected colon cancer. JAMA . 1993;;270:943-947.
22 +
Childs B, Gordis L, Kaback MM, Kazazian HG.  Tay-Sachs screening: social and psychological impact. Am J Hum Genet . 1976;;28:550-558.
23 +
Whitten CF.  Sickle-cell programming: an imperiled promise. N Engl J Med . 1973;;288:316-319.
24 +
US Preventive Services Task Force.  Home uterine activity monitoring for preterm labor: policy statement. JAMA . 1993;;270:369-370.
25 +
Committee on Clinical Practice Healthcare Services, Institute of Medicine. Guidelines for Clinical Practice: From Development to Use . Washington, DC: National Academy Press; 1992;.
26 +
Nolan K, Swenson S.  New tools, new dilemmas: genetic frontiers. Hastings Cent Rep . 1988;;18:40-46.
27 +
Wilfond BS, Fost N.  The cystic fibrosis gene: medical and social implications for heterozygote detection. JAMA . 1990;;263:2777-2783.
28 +
Faden RR, Beauchamp TL. A History and Theory of Informed Consent . New York, NY: Oxford University Press; 1986;.
29 +
Annas GJ, Elias S.  The major social policy issues raised by the Human Genome Project.  In: Annas GJ, Elias S, eds. Gene Mapping: Using Law and Ethics as Guides . New York, NY: Oxford University Press; 1992;:3-17.
30 +
Bekker H, Modell M, Denniss G, et al.  Uptake of cystic fibrosis testing in primary care: supply push or demand pull? BMJ . 1993;;306:1584-1586.
31 +
Abram MB, Wolf SM.  Public involvement in medical ethics. N Engl J Med . 1984;;310:627-632.
32 +
Lobeck C, Mangos J. Psychosocial Aspects of Heterozygote Detection in Cystic Fibrosis . Bethesda, Md: Cystic Fibrosis Foundation; 1974;.
33 +
Riordan JR, Rommens JM, Kerem BS, et al.  Identification of the cystic fibrosis gene: cloning and characterization of complementary DNA. Science . 1989;;245:1066-1073.
34 +
US Congress Office of Technology Assessment. Cystic Fibrosis and DNA Tests: Implications of Carrier Screening . Washington, DC: US Congress Office of Technology Assessment; 1992;.
35 +
Caskey CT, Kaback MM, Beaudet AL.  The American Society of Human Genetics statement on cystic fibrosis. Am J Hum Genet . 1990;;46:393.
36 +
Roberts L.  To test or not to test? Science . 1990;; 247:17-20.
37 +
Workshop on Population Screening for the Cystic Fibrosis Gene.  Statement from the National Institutes of Health Workshop on Population Screening for the Cystic Fibrosis Gene. N Engl J Med . 1990;;323:70-71.
38 +
Roberts L.  CF screening delayed for awhile, perhaps forever. Science . 1990;;247:1296-1297.
39 +
Roberts L.  Cystic fibrosis projects go begging. Science . 1990;;250:1076.
40 +
Wilfond BS, Fost N. Cystic fibrosis heterozygote detection: the introduction of genetic testing into clinical practice . An unpublished report prepared for the Ethical, Legal, and Social Implications Program of the National Center for Human Genome Research. Bethesda, Md: National Institutes of Health; 1990;.
41 +
 Hopeful news for CF pilot studies. Science . 1990;; 250:1514-1515.
42 +
Kolata G.  Some doctors deplore move to test for cystic fibrosis: even partial results justify screening, supporters say. NY Times . (May 22) , 1990;:B7.
43 +
Schulman JD, Maddalena A, Black SH, Bick DP.  Screening for cystic fibrosis carriers. Am J Hum Genet . 1990;;47:470.
44 +
Brock D.  Population screening for cystic fibrosis. Am J Hum Genet . 1990;;47:164-165.
45 +
Bick D, Black SH, Cummings E, et al.  Prenatal screening for ΔF508 mutation in population not selected for cystic fibrosis. Lancet . 1990;;336:1324-1325.
46 +
Biesecker L, Bowles-Biesecker B, Collins F, Kaback M, Wilfond B.  General population screening for cystic fibrosis is premature. Am J Hum Genet . 1992;;50:438-439.
47 +
American Society of Human Genetics Board of Directors.  Statement of the American Society of Human Genetics on cystic fibrosis carrier screening. Am J Hum Genet . 1992;;51:1443-1444.
48 +
Council on Ethical and Judicial Affairs. Ethical Issues in Carrier Screening for Cystic Fibrosis and Other Genetic Disorders: Proceedings of the House of Delegates . Chicago, Ill: American Medical Association; 1991;.
49 +
Committee on Obstetrics, Maternal and Fetal Medicine. American College of Obstetricians and Gynecologists Committee Opinion: Current Status of Cystic Fibrosis Carrier Screening . Washington, DC: American College of Obstetricians and Gynecologists; 1991;.
50 +
Nishimi RY.  Cystic fibrosis and DNA tests: the implications of carrier screening. JAMA . 1993;;269: 1921.
51 +
Committee on Government Operations. Designing Genetic Information Policy: The Need for an Independent Policy Review of the Ethical, Legal, and Social Implications of the Human Genome Project . Washington, DC: Committee on Government Operations; 1992;.
52 +
Fost N.  Ethical implications of screening asymptomatic individuals. FASEB J . 1992;;6:2813-2817.
53 +
Holtzman NA. Proceed With Caution: Predicting Genetic Risks in the Recombinant DNA Era . Baltimore, Md: Johns Hopkins University Press; 1989;.
54 +
Committee to Advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine. Clinical Practice Guidelines: Directions for a New Program . Washington, DC: National Academy Press; 1990;.
55 +
Hanna KE, Cook-Deegan RM, Nishimi RM.  Finding a forum for bioethics in US public policy. Polit Life Sci . 1993;;12:205-219.
56 +
Maryland Annotated Code, article 43, §814-821. 1978 cumulative supplement, 1993.
57 +
Holtzman NA.  Public participation in genetic policymaking.  In: Milunsky A, Annas GJ, eds. Genetics and the Law II . New York, NY: Plenum Press; 1980;:247-258.
58 +
Walters L.  Human gene therapy: ethics and public policy. Hum Gene Ther . 1991;;2:115-122.
59 +
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Splicing Life: The Social and Ethical Issues of Genetic Engineering With Human Beings . Washington, DC: President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research; 1982;.
60 +
Carmen H.  Debates, divisions, and decisions: Recombinant DNA Advisory Committee (RAC) authorization of the first human gene transfer experiment. Am J Hum Genet . 1992;;50:245-260.
61 +
Walters L.  A national advisory committee on genetic testing and screening , In: Annas GJ, Elias S, eds. Gene Mapping: Using Law and Ethics as Guides . New York, NY: Oxford University Press; 1992;:255-266.
62 +
Gore A.  Federal biotechnology policy: the perils of progress and the risks of uncertainty. J Law Reform . 1987;;20:965-977.
63 +
Andrews L, Fullerton J, Holtzman NA, Motulsky A, eds. Assessing Genetic Risks: Implications for Health and Social Policy . Washington, DC: Institute of Medicine, National Academy Press; 1993;.

Figures

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Interactive Graphics

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Caskey CT.  Molecular medicine: a spin-off from the helix. JAMA . 1993;;269:1986-1992.
2 +
Holtzman NA.  The diffusion of new genetic tests for predicting disease. FASEB J . 1992;;6:2806-2812.
3 +
Fearon ER, Jones PA.  Progessing toward a molecular description of colorectal cancer development. FASEB J . 1992;;6:2783-2790.
4 +
Biesecker BB, Boehnke M, Calzone K, et al.  Genetic counseling for families with inherited susceptability to breast and ovarian cancer. JAMA . 1993;; 269:1970-1974.
5 +
MacCluer JW, Kammerer CM.  Dissecting the genetic contribution to coronary heart disease. Am J Hum Genet . 1991;;49:1139-1144.
6 +
Corder EH, Saunders AM, Strittmatter WJ, et al.  Gene dose of apolipoprotein E type 4 allele and the risks of Alzheimer's disease in late onset families. Science . 1993;;261:921-923.
7 +
Nolan K.  First fruits: genetic screening. Hastings Cent Rep . 1992;;22, (No. (4) special suppl):S2-S4.
8 +
Wilfond BS, Fost N.  The introduction of cystic fibrosis carrier screening into clinical practice: policy considerations. Milbank Q . 1992;;70:629-659.
9 +
Lappé M, Gustafson J, Roblin R.  Ethical and social issues in screening for genetic disease. N Engl J Med . 1972;;286:1129-1132.
10 +
Committee on Inborn Errors of Metabolism. Genetic Screening: Programs, Principles, and Research . Washington, DC: National Academy of Sciences; 1975;.
11 +
Screening and Counseling for Genetic Conditions: The Ethical, Social, and Legal Implications of Genetic Screening, Counseling, and Education Programs . Washington, DC: President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research; 1983;.
12 +
Levine C, Dubler NN.  Uncertain risks and bitter realities: the reproductive choices of HIV-infected women. Milbank Q . 1990;;68:321-351.
13 +
Billings PR, Kohn MA, de Cuevas M, Beckwith J, Alper JS, Natowicz MR.  Discrimination as a consequence of genetic testing. Am J Hum Genet . 1992;;50:476-482.
14 +
Holtzman NA, Rothstein MA.  Eugenics and genetic discrimination. Am J Hum Genet . 1992;;50: 457-459.
15 +
Wiggins S, Whyte P, Huggins M, et al.  The psychological consequences of predictive testing for Huntington's disease. N Engl J Med . 1992;;327: 1401-1405.
16 +
Ostrer H, Allen W, Crandall LA, et al.  Insurance and genetic testing: where are we now? Am J Hum Genet . 1993;;52:565-577.
17 +
Reilly P. Genetics, Law, and Social Policy . Cambridge, Mass: Harvard University Press; 1977;.
18 +
Bessman SP, Swazey JP.  PKU: a study of biomedical legislation.  In: Mendelsohn E, Swazey JP, Taviss I, eds. Human Aspects of Biomedical Innovation . Cambridge, Mass: Harvard University Press; 1971;:49-76.
19 +
American Academy of Pediatrics.  Statement on compulsory testing of newborn infants for hereditary metabolic disorders. Pediatrics . 1967;;39: 623.
20 +
Elias S, Annas GJ, Simpson JL.  Carrier screening for cystic fibrosis: a case study in setting standards of medical practice.  In: Annas GJ, Elias S, eds. Gene Mapping: Using Law and Ethics as Guides . New York, NY: Oxford University Press; 1992;:186-202.
21 +
Moertel CG,Fleming TR,MacDonald JS, Haller DG, Laurie JA, Tangen C.  An evaluation of the carcinoembryonic antigen (CEA) test for monitoring patients with resected colon cancer. JAMA . 1993;;270:943-947.
22 +
Childs B, Gordis L, Kaback MM, Kazazian HG.  Tay-Sachs screening: social and psychological impact. Am J Hum Genet . 1976;;28:550-558.
23 +
Whitten CF.  Sickle-cell programming: an imperiled promise. N Engl J Med . 1973;;288:316-319.
24 +
US Preventive Services Task Force.  Home uterine activity monitoring for preterm labor: policy statement. JAMA . 1993;;270:369-370.
25 +
Committee on Clinical Practice Healthcare Services, Institute of Medicine. Guidelines for Clinical Practice: From Development to Use . Washington, DC: National Academy Press; 1992;.
26 +
Nolan K, Swenson S.  New tools, new dilemmas: genetic frontiers. Hastings Cent Rep . 1988;;18:40-46.
27 +
Wilfond BS, Fost N.  The cystic fibrosis gene: medical and social implications for heterozygote detection. JAMA . 1990;;263:2777-2783.
28 +
Faden RR, Beauchamp TL. A History and Theory of Informed Consent . New York, NY: Oxford University Press; 1986;.
29 +
Annas GJ, Elias S.  The major social policy issues raised by the Human Genome Project.  In: Annas GJ, Elias S, eds. Gene Mapping: Using Law and Ethics as Guides . New York, NY: Oxford University Press; 1992;:3-17.
30 +
Bekker H, Modell M, Denniss G, et al.  Uptake of cystic fibrosis testing in primary care: supply push or demand pull? BMJ . 1993;;306:1584-1586.
31 +
Abram MB, Wolf SM.  Public involvement in medical ethics. N Engl J Med . 1984;;310:627-632.
32 +
Lobeck C, Mangos J. Psychosocial Aspects of Heterozygote Detection in Cystic Fibrosis . Bethesda, Md: Cystic Fibrosis Foundation; 1974;.
33 +
Riordan JR, Rommens JM, Kerem BS, et al.  Identification of the cystic fibrosis gene: cloning and characterization of complementary DNA. Science . 1989;;245:1066-1073.
34 +
US Congress Office of Technology Assessment. Cystic Fibrosis and DNA Tests: Implications of Carrier Screening . Washington, DC: US Congress Office of Technology Assessment; 1992;.
35 +
Caskey CT, Kaback MM, Beaudet AL.  The American Society of Human Genetics statement on cystic fibrosis. Am J Hum Genet . 1990;;46:393.
36 +
Roberts L.  To test or not to test? Science . 1990;; 247:17-20.
37 +
Workshop on Population Screening for the Cystic Fibrosis Gene.  Statement from the National Institutes of Health Workshop on Population Screening for the Cystic Fibrosis Gene. N Engl J Med . 1990;;323:70-71.
38 +
Roberts L.  CF screening delayed for awhile, perhaps forever. Science . 1990;;247:1296-1297.
39 +
Roberts L.  Cystic fibrosis projects go begging. Science . 1990;;250:1076.
40 +
Wilfond BS, Fost N. Cystic fibrosis heterozygote detection: the introduction of genetic testing into clinical practice . An unpublished report prepared for the Ethical, Legal, and Social Implications Program of the National Center for Human Genome Research. Bethesda, Md: National Institutes of Health; 1990;.
41 +
 Hopeful news for CF pilot studies. Science . 1990;; 250:1514-1515.
42 +
Kolata G.  Some doctors deplore move to test for cystic fibrosis: even partial results justify screening, supporters say. NY Times . (May 22) , 1990;:B7.
43 +
Schulman JD, Maddalena A, Black SH, Bick DP.  Screening for cystic fibrosis carriers. Am J Hum Genet . 1990;;47:470.
44 +
Brock D.  Population screening for cystic fibrosis. Am J Hum Genet . 1990;;47:164-165.
45 +
Bick D, Black SH, Cummings E, et al.  Prenatal screening for ΔF508 mutation in population not selected for cystic fibrosis. Lancet . 1990;;336:1324-1325.
46 +
Biesecker L, Bowles-Biesecker B, Collins F, Kaback M, Wilfond B.  General population screening for cystic fibrosis is premature. Am J Hum Genet . 1992;;50:438-439.
47 +
American Society of Human Genetics Board of Directors.  Statement of the American Society of Human Genetics on cystic fibrosis carrier screening. Am J Hum Genet . 1992;;51:1443-1444.
48 +
Council on Ethical and Judicial Affairs. Ethical Issues in Carrier Screening for Cystic Fibrosis and Other Genetic Disorders: Proceedings of the House of Delegates . Chicago, Ill: American Medical Association; 1991;.
49 +
Committee on Obstetrics, Maternal and Fetal Medicine. American College of Obstetricians and Gynecologists Committee Opinion: Current Status of Cystic Fibrosis Carrier Screening . Washington, DC: American College of Obstetricians and Gynecologists; 1991;.
50 +
Nishimi RY.  Cystic fibrosis and DNA tests: the implications of carrier screening. JAMA . 1993;;269: 1921.
51 +
Committee on Government Operations. Designing Genetic Information Policy: The Need for an Independent Policy Review of the Ethical, Legal, and Social Implications of the Human Genome Project . Washington, DC: Committee on Government Operations; 1992;.
52 +
Fost N.  Ethical implications of screening asymptomatic individuals. FASEB J . 1992;;6:2813-2817.
53 +
Holtzman NA. Proceed With Caution: Predicting Genetic Risks in the Recombinant DNA Era . Baltimore, Md: Johns Hopkins University Press; 1989;.
54 +
Committee to Advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine. Clinical Practice Guidelines: Directions for a New Program . Washington, DC: National Academy Press; 1990;.
55 +
Hanna KE, Cook-Deegan RM, Nishimi RM.  Finding a forum for bioethics in US public policy. Polit Life Sci . 1993;;12:205-219.
56 +
Maryland Annotated Code, article 43, §814-821. 1978 cumulative supplement, 1993.
57 +
Holtzman NA.  Public participation in genetic policymaking.  In: Milunsky A, Annas GJ, eds. Genetics and the Law II . New York, NY: Plenum Press; 1980;:247-258.
58 +
Walters L.  Human gene therapy: ethics and public policy. Hum Gene Ther . 1991;;2:115-122.
59 +
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Splicing Life: The Social and Ethical Issues of Genetic Engineering With Human Beings . Washington, DC: President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research; 1982;.
60 +
Carmen H.  Debates, divisions, and decisions: Recombinant DNA Advisory Committee (RAC) authorization of the first human gene transfer experiment. Am J Hum Genet . 1992;;50:245-260.
61 +
Walters L.  A national advisory committee on genetic testing and screening , In: Annas GJ, Elias S, eds. Gene Mapping: Using Law and Ethics as Guides . New York, NY: Oxford University Press; 1992;:255-266.
62 +
Gore A.  Federal biotechnology policy: the perils of progress and the risks of uncertainty. J Law Reform . 1987;;20:965-977.
63 +
Andrews L, Fullerton J, Holtzman NA, Motulsky A, eds. Assessing Genetic Risks: Implications for Health and Social Policy . Washington, DC: Institute of Medicine, National Academy Press; 1993;.

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