Hostname: page-component-586b7cd67f-rcrh6 Total loading time: 0 Render date: 2024-11-28T00:10:04.641Z Has data issue: false hasContentIssue false
  • English
  • Français

Getting to Market: The Scientific and Legal Climate for Developing an AIDS Vaccine

Published online by Cambridge University Press:  28 April 2021

Wendy K. Mariner  and
Robert C. Gallo
Get access Rights & Permissions [Opens in a new window]

Extract

Expectations of a vaccine to prevent acquired immunodeficiency syndrome (AIDS) are rising. Not only are the prospects for an effective immunogen improving, but immunization appears to hold the greatest promise for halting the spread of infection and disease. Identification of the causal agent—the retrovirus called HTLV-IIII, LAV, or generically, HIV (human immunodeficiency virus)—has provided the direction and limited the options for containing the disease.

Prevention is, of course, critical where the disease must be presumed to be fatal in all cases. Although there is no clear evidence that any single exposure-to HIV will result in infection or disease, prudence dictates that all exposures be considered potentially infectious and, ultimately, disease-producing until more is known. Public education or, more specifically, behavior modification, intended to reduce or eliminate unsafe sexual contact and the sharing of syringes and needles by users of illicit intravenous (IV) drugs, is perhaps the only effective means of prevention that currently exists.

Type
Article
Information
Law, Medicine and Healthcare , Volume 15 , Issue 1-2 , Summer 1987 , pp. 17 - 26
Copyright
Copyright © American Society of Law, Medicine and Ethics 1987

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

*

The authors gratefully acknowledge the assistance of Ann H. Sliski, D.Sc., of the Narional Cancer Institute, in the preparation of rhis article.

References

Experts find lag on testing drugs in AIDS patients, New York Times, April 12, 1987: 1; Secrecy in AIDS research, Boston Globe, April 13, 1987: 43.Google Scholar
DeGruttola, V, Mayer, K, Bennett, W, AIDS: Has the problem been adequately assessed?, Reviews of Infectious Diseases 1986, 8: 295–305; May, RM, Anderson, RM, Transmission dynamics of HIV infection, Nature 1987, 326: 137-42.Google Scholar
Drotman, DP, Now is the time to prevent AIDS, American Journal of Public Health 1987, 77:143; Koop, CE, Surgeon general's report on acquired immune deficiency syndrome, Washington, D.C., 1986. While the control of blood and blood products is an important method of prevention, it cannot protect the entire population at risk, since transmission by such routes has not been a major factor in the spread of infection.Google Scholar
Brandt, AM, No magic bullet: A social history of venereal disease in the United States since 1880, New York: Oxford University Press, 1985.Google Scholar
DeGruttola, , Mayer, , Bennett, , supra note 2.Google Scholar
Fischinger, PJ et al., Current status and strategies for vaccine against diseases induced by human T-cell lymphotropic retroviruses (HTLV-I, II, II), Cancer Research (Suppl.) 1985, 45: 4694s–99s; Fischinger, PJ, Gallo, RC, Bolognesi, DP, Towards a vaccine against AIDS: Rationale and current progress, Mt. Sinai Journal of Medicine, forthcoming; Bolognesi, DP, Fischinger, PJ, Gallo, RC, Prospects for development of a vaccine against HTLV-III disease, in Notkins, and Okistone, , eds., Concepts in viral pathogenesis II, Springer-Verlag, 1986: 354–64.Google Scholar
Jarrett, WFH, in Origins of human cancer, New York: Cold Spring Laboratory, 1977.Google Scholar
Schafer, W, Bolognesi, DP, Mammalian C-type oncornaviruses: Relationship between viral, structural cell surface antigens and their possible significance in immunological defense mechanisms, in Hanna, MG Jr., Rapp, F, eds., Contemporary Topics in Immunobiology 1977, 6: 127.Google Scholar
Sarngadharan, MG et al., Antibodies reactive with human T-lymphotropic retroviruses (HTLV-III) in the serum of patients with AIDS, Science 1984, 224: 506.Google Scholar
Robert-Guroff, M, Brown, M, Gallo, RC, HTLV-III-neutralizing antibodies in patients with AIDS and AIDS-related complex, Nature 1985, 316: 72–74.Google ScholarPubMed
Hahn, HN et al., Genomic diversity of the acquired immunodeficiency syndrome virus HTLV-III; Different viruses exhibit greatest divergence in their envelope gene, Proceedings of the National Academy of Science USA 1985, 82: 4813–17.Google Scholar
Id.Google Scholar
Robert-Guroff, , Brown, , Gallo, , supra note 10.Google Scholar
Starcich, BR et al., Identification and characterization of conserved and variable regions in the envelope gene of HTLV-III/LAV, the retrovirus of AIDS, Cell 1986, 45: 637–48.Google Scholar
Elder, JH, McGee, JS, Alexander, S, Carbohydrate side chains of Rauscher leukemia virus envelope glycoprotein are not required to elicit a neutralizing antibody response, Journal of Virology 1986, 57: 340–42.Google Scholar
Ratner, L et al., Complete nucleotide sequence of the AIDS virus, HTLV-III, Nature 1985, 313: 277–84.Google ScholarPubMed
Hunsmann, G, Schneider, J, Schulz, A, Immunoprevention of Friend virus-induced erythroleukemia by vaccination with viral envelope glycoprotein complex, Virology 1981, 113: 602–12.CrossRefGoogle Scholar
Chakrabarti, S et al., Expression of the HTLV-III envelope gene by a recombinant vaccinia virus, Nature 1986, 320: 535–37; Hu, S-L, Kosowski, SG, Dalrymple, JM, Expression of AIDS virus envelope gene in recombinant vaccinia viruses, Nature 1986, 320: 537–40.Google Scholar
Putney, SD et al., HTLV-III/LAV neutralizing antibodies to an E. coli-produced fragment of the virus envelope, Science 1986, 234: 1392–95.Google Scholar
Id.Google Scholar
Immunization of children infected with human T-lymphotropic virus type III/lymphadenopathy-associated virus, Morbidity and Mortality Weekly Report 1986, 35: 595–606.Google Scholar
Redfield, RR et al., Disseminated vaccinia in a military recruit with human immunodeficiency virus (HIV) disease, New England Journal of Medicine 1987, 316: 673–76.Google Scholar
Koprowski, H, Unconventional vaccines: Immunization with anti-idiotype antibody against viral diseases, Cancer Research (Suppl.) 1985, 45: 4689s–90s.Google ScholarPubMed
The FDA's Office of Biologies regulates the licensing of vaccines under the FDA's general power of approval with respect to all drug products as well as specific requirements for vaccines. Food, Drug and Cosmetic Act, 52 Stat. 1040 (1938), as amended, 21 U.S.C. §§301 et seq.; Public Health Service Act, 42 U.S.C. §§210 et seq., originally enacted as the Virus, Serum and Toxin Act of 1944, 58 Stat. 682 (1944).Google Scholar
21 C.F.R. §§T630.1–87. Beyond initial licensing, the Office of Biologics tests samples of each lot of vaccine to be distributed. 21 C.F.R. §§630.17, 630.18. Only federally licensed manufacturers may market vaccines in the United States. 42 U.S.C. §262 (a)(1).Google Scholar
Fuhz, PN et al., Persistent infection of chimpanzees with human T-lymphotropic virus type III/lymphadenopathy-associated virus: A potential model for acquired immunodeficiency syndrome, Journal of Virology 1986, 58: 116–24.Google Scholar
Singer, P, Animal liberation, New York, 1975.Google Scholar
Feorino, PM et al., Transfusion-associated acquired immunodeficiency syndrome: Evidence for persistent infection in blood donors, New England Journal of Medicine 1985, 312: 1293–96; Maloney, MJ et al., AIDS in a child 5 1/2 years after a transfusion (letter), New England Journal of Medicine 1985, 312: 1256.Google ScholarPubMed
Jaffe, HW et al., The acquired immunodeficiency syndrome in a cohort of homosexual men: A six-year follow-up study, Annals of Internal Medicine 1985, 103: 210–14; Centers for Disease Control, Update: Acquired immunodeficiency syndrome in the San Francisco cohort study, 1978–1985, Morbidity and Mortality Weekly Report 1985, 34: 573-75.Google Scholar
Toner v. Lederle Laboratories, 732 P. 2d 297 (Id. 1987); Kearl v. Lederle Laboratories, 172 Cal. App. 3d 812, 218 Cal. Rptr. 453 (Cal. App. 1st Dist. 1985).Google Scholar
Prosser, W, Keeton, K, The Law of torts, 5th ed., 1984. Griffin v. United States, 351 F. Supp. 10 (E.D.Pa. 1972), 353 F. Supp. 324 (E.D.Pa. 1973) (adulteration); Tinnerholm v. Parke-Davis & Co., 285 F. Supp. 432 (S.D.N.Y. 1968), aff'd 411 F.2d 48 (2d Cir. 1969) (inadequate testing); Alman Bros. Farms and Feed Mills, Inc. v. Diamond Laboratories, Inc., 437 F.2d 1295 (5th Cir. 1971) (improper labeling).Google Scholar
American Law Institute, Restatement (Second) of Torts, §402A, comments g and i (1965). Wade, J, On the nature of strict liability for products, Mississippi Law Journal 1973, 44: 825.Google Scholar
Manufacturing defects are errors in the manufacturing process that result in the product having an unintentionally altered or contaminated component and that affect only specific batches of the product. Greenman v. Yuba Power Products, Inc., 59 Cal. 2d 57, 27 Cal. Rptr. 697 (1963).Google Scholar
A defect in product design is a flaw inherent in the specifications of the product as it is intended to be produced, an integral component of every unit made. Page, J, “Generic product risks,” the case against comment k and for strict liability, New York University Law Review 1983, 58: 853.Google Scholar
Givens v. Lederle, 556 F.2d 1341 (5th Cir. 1977); Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), cert. denied, 419 U.S. 1096 (1974); Davis v. Wyeth Laboratories, 399 F. 2d 121 (9th Cir. 1968).Google Scholar
Mariner, WK, Clark, ME, Confronting the immunization problem: Proposals for compensation reform, American Journal of Public Health 1986, 76: 703–8; Institute of Medicine, Vaccine Supply and Innovation, 85–122, Washington, D.C.: National Academy Press, 1985; U.S. Congress, Office of Technology Assessment, Compensation for vaccine-related injuries, 1980; U.S. Congress, Office of Technology Assessment, A review of selected federal vaccine and immunization policies, 1979; U.S. Dept. of Health, Education and Welfare, Liability arising out of immunization programs: Final report, 1978; Baynes, TE, Liability for vaccine-related injuries: Public health considerations and some reflections on the swine flu experience, St. Louis University Law Journal 1977, 21: 44; Comment, Informed consent to immunization: The risks and benefits of individual autonomy, California Law Review 1977, 65: 1286.Google ScholarPubMed
Toner v. Lederle Laboratories, 732 P. 2d 297 (Id. 1987).Google Scholar
The number of vaccine producers has already declined significantly, partly because of fear of liability. Institute of Medicine, supra note 36; Mariner, and Clark, , supra note 36.Google Scholar
American Law Institute, supra note 32.Google Scholar
Comment g to sec. 402A defines “defecrive condition” as “a condition not contemplated by the ultimate consumer, which will be unreasonably dangerous to him.”Google Scholar
Comment i to sec. 402A defines “unreasonably dangerous” as a “danger beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.”Google Scholar
Institute of Medicine, supra note 36.Google Scholar
Comment k provides, in part: “There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.”Google Scholar
218 Cal. Rptr. at 460.Google Scholar
Id.: 463, n. 12, quoting from Feldman v. Lederle Laboratories, 97 N.J. 429 (1984).Google Scholar
Id.: 464.Google Scholar
Id.Google Scholar
Schwartz, V, Unavoidably unsafe products: Clarifying the meaning and policy behind comment k, Washington & Lee Law Review 1985, 42: 1139; Willig, S, The comment k character: A conceptual barrier to strict liability, Mercer Law Review 1978. 29: 545.Google Scholar
218 Cal. Rptr. at 464.Google Scholar
Toner v. Lederle Laboratories, 732 P. 2d 297 (Id. 1987).Google Scholar
Johnson v. American Cyanamid, 239 Kan. 279, 718 P. 2d 1318 (1986).Google Scholar
Brown v. Superior Court, 227 Cal. Rptr. 768, 774 (Cal. App. 1st Dist. 1986).Google Scholar
Redfield, et al., supra note 22.Google Scholar
Comment k states that its limitation on liability “is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk.”Google Scholar
Willig, , supra note 48.Google Scholar
Remarks to the Harvard University Division on Health Policy Research and Education, Health Science Policy Working Group, Subgroup on Regulation, Boston, Massachusetts, March 31, 1987.Google Scholar
Toner v. Lederle Laboratories, 732 P. 2d at 313 (Huntley, J., concurring).Google Scholar
Mariner, WK, McArdle, PA, Consent forms, readability, and comprehension: The need for new assessment tools, Law, Medicine & Health Care 1985, 13: 68–74.Google ScholarPubMed
Johnson v. American Cyanamid, 239 Kan. 279, 718 P. 2d 1318 (1986); Dunn v. Lederle Laboratories, 328 N.W.2d 576 (Mich. Ct. App. 1982); Bean v. United States, 533 F. Supp. 567 (D. Colo. 1980).Google Scholar
The act was signed into law in November 1986 without an initial funding mechanism, so it remains to be seen whether and how it will be implemented. The act covers listed disabilities that are deemed to result from vaccination against diphtheria, pertussis (whooping cough), tetanus, polio, measles, mumps, and rubella, most of which are required for school entry in all the United States. Compensation is to be paid for medical expenses over $1,000, actual and anticipated losses of earnings, and up to $250,000 for non-economic injuries; $250,000 is payable in the event of death. Limitations on the kind and amount of compensation payable are imposed depending upon the date of the vaccination in question. Claims are to be submitted to a United States district court for determination. Claimants may accept the decision of the court or may file a civil action seeking damages if they have a cause of action.Google Scholar
California Health and Safety Code, chap. 1.14 (1986). California also has a limited program of compensation (up to $25,000 in medical expenses) for persons injured as a result of a vaccination required for children under California law. Calif. Health and Safety Code, §429.35. For a description of that program, see Mariner, WK, California's compensation system, in Comparison of compensation programs for vaccine injury, report to the National Center for Health Services Research and Health Care Technology Assessment, 1986: 101–21. North Carolina enacted a compensation program in 1986 similar to the federal system, but it may lapse if the federal scheme is funded.Google Scholar
In addition, injuries for which a manufacturer is found liable in a court of law and injuries attributable to the comparative negligence of the injured person are not covered. Calif. Health and Safety Code, chap. 1.14, §199.50(c).Google Scholar
Calif. Health and Safety Code, chap. 1.14, §199.49(a)(3).Google Scholar
Kitch, EW, The vaccine dilemma, Issues in Science and Technology 1986, 2:108–21. However, HIV infection induced by a subunit vaccine could be distinguished from natural infection by the antibody response.Google ScholarPubMed
Mariner, WK, Comparison of statutory vaccine injury compensation programs, in Comparison of compensation programs for vaccine injury, 17–22, supra note 61.Google Scholar