Hostname: page-component-586b7cd67f-l7hp2 Total loading time: 0 Render date: 2024-11-24T04:31:36.091Z Has data issue: false hasContentIssue false
  • English
  • Français

Appropriate Collaboration between Industry and Government in the Development of an AIDS Vaccine

Published online by Cambridge University Press:  29 April 2021

Nicholas A. Christakis  and
Morris J. Panner
Get access Rights & Permissions [Opens in a new window]

Extract

On August 22, 1986, as part of its response to the AIDS epidemic, the Public Health Service (PHS) invited U.S. industrial firms to collaborate with the government in the development of an AIDS vaccine. The framework for the collaboration was outlined in a PHS document entitled, “AIDS Vaccine Development: Private Sector/Government Collaborative Efforts.” This document identified the resources the government is prepared to make available to industry, including patents, facilities, data, and assistance with clinical trials. The overall aim of the PHS proposal was to establish a formal framework for coordinating existing government and private efforts and to foster industry participation in the search for an AIDS vaccine.

An example of private sector/government collaboration is provided in the human trial of an AIDS vaccine approved by the FDA in August 1987. The vaccine, named “VaxSyn HIV-1,“ is the product of a joint effort between a company called MicroGeneSys and investigators at the National Institute of Allergy and Infectious Disease (NIAID).

Type
Article
Information
Law, Medicine and Healthcare , Volume 17 , Issue 2 , Summer 1989 , pp. 130 - 138
Copyright
Copyright © American Society of Law, Medicine and Ethics 1989

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.)

References

51 Fed. Reg. 30130, August 22, 1986.Google Scholar
“HIV Vaccine Approved for Clinical Trials,” Journal of the American Medical Association 258 (1987): 1433–1434. See also “AIDS Vaccine Development Targetted by NIAID Funds,” American Medical News, January 15, 1988, p. 11.Google Scholar
For a discussion of some of these points, see Koff, W.C. Hoth, D.F., “Development and Testing of AIDS Vaccines,” Science 241 (1988): 426–432. See also Mariner, W.K. Gallo, R.C., “Getting to Market: The Scientific and Legal Climate for Developing an AIDS Vaccine,” Law, Medicine, and Health Care 15 (1–2) (1987): 17–26.Google Scholar
51 Fed. Reg. 30130, August 22, 1986. For a list of the AIDS vaccines recently under development along with the companies involved, see Foreman, J., “Is an AIDS Vaccine Possible?” The Boston Globe, October 14, 1987, p. 48.Google Scholar
Nevertheless, some success using preparations of whole killed virus or portions of killed virus has been noted in the case of other kinds of retroviruses infecting, for example, monkeys; see Marx, P.A. et al., “Prevention of Simian Acquired Immunodeficiency Syndrome with a Formalin-Inactivated Type D Retrovirus Vaccine,” Journal of Virology 60 (1986): 431–435.Google Scholar
The only vaccine trial for which results have so far been published involved this technique; see, Zagury, D. et al., “Immunization Against AIDS in Humans,” Nature 326 (1987): 249–250.Google Scholar
Francis, D.P. Petricciani, J.C., “The Prospects for and Pathways toward a Vaccine for AIDS,” New England Journal of Medicine 313 (1985): 1586–1590.Google Scholar
For more on the scientific and ethical design of an AIDS vaccine trial, see Christakis, N.A., “The Ethical Design of an AIDS Vaccine Trial in Africa,” Hastings Center Report 18(3) (1988): 31–37.Google Scholar
See 49 Fed. Reg. 18900, May 3, 1984. See also Altman, L.K., “U.S. Delays Licensing of Blood Test to Detect AIDS,” The New York Times, February 15, 1985, p. B16; Pear, R., “AIDS Blood Test to be Available in 2–6 weeks,” The New York Times, March 3, 1985, p. A23; and “Crash Development of AIDS Test Nears Goal,” Science 225: 1128–1131 (1984).Google Scholar
For recommendations in this regard, see Burns, J.J. Groopman, J.E., “AIDS: Strategic Considerations for Developing Antiviral Drugs,” Issues in Science and Technology 3(2) (1987): 102–110.Google Scholar
In addition to AZT, there are eight other drugs related to AIDS that have been designated as orphan drugs by the federal Orphan Products Board. To qualify as an orphan drug, the Orphan Drug Act, P.L. 97-414, 96 Stat. 2049 (1983) establishes that the drug must be for the treatment of a disease or condition affecting fewer than 200,000 people in the U.S. or, alternatively, a condition affecting more than 200,000 but for which there is no expectation that the drug development cost will be recovered; in addition, see Orphan Drug Amendment of 1985, Title 21, §360aa et seq. P.L. 99-91, 99 Stat 387 (1985). See “Orphan Drug Designation Given to Nine Medications,” AIDS Policy and Law, October 21, 1987, at p. 5. These eight drugs, in addition to AZT, have been given 1-AA status by the FDA, the highest priority in the agency's drug review process. See also Boffey, P.M., “U.S. to Relax Rules on Experimental Drugs,” The New York Times, March 11, 1987, p. A24.Google Scholar
See Francis, D.P. Petricciani, J.C., supra note 7, and also a letter from Wetzler, L. Seiff, M. E., “AIDS Vaccine and the Private Sector,” New England Journal of Medicine 314: 1511–1512 (1985). The problem of competition and secrecy is not restricted to the private sector; incentives for secrecy also exist for public sector scientists; see Forsdyke, D.R., “An Ethical Dilemma” (letter), Nature 332: 200 (March 1988).Google Scholar
See Neustadt, R. Fineberg, H.V., The Epidemic that Never Was: Policy Making in the Swine Flu Scare, New York: Vintage Books, 1983, for a discussion of a previous case of collaboration in a vaccine program.Google Scholar
Fed. Reg. 30130, August 22, 1986, at p. 30131. The need for such manufacturing and distribution expertise was identified even earlier in a report released in 1985 by the Congressional Office of Technology Assessment: U.S. Congress, Office of Technology Assessment, Review of the Public Health Service's Response to AIDS, Washington, D.C.: U.S. Congress, OTA, February, 1985.Google Scholar
California has also moved ahead of the federal government in drug approval, recently passing legislation to permit bypassing of FDA review of new drugs; Session Laws under AIDS, California Health and Safety Code, Chap. 6, §26679.5 (1987). See also Bishop, K., “California Acts to Speed AIDS Drug Testing,” The New York Times, September 30, 1987, p. A18.Google Scholar
California Health and Safety Code, chaps. 1.14 and 1.15 (1986).Google Scholar
California Health and Safety Code, chap. 1.14, §199-45(0).Google Scholar
For example, see Mills, J.L. Alexander, D., “Teratogens and ‘Litogens,’” New England Journal of Medicine 315(19): 1234–1236 (1986); and, for analysis of proposals to revamp vaccine liability law, see: Kitch, E.W., “The Vaccine Dilemma,” Issues in Science and Technology 2: 108–121 (1986).Google Scholar
Barnes, P.M., “Will an AIDS Vaccine Bankrupt the Company that Makes It?” Science 233: 1035 (1986).Google Scholar
172 Cal. App.3d 812.Google Scholar
California Health and Safety Code, chap. 1.14, §199.50(0). On the federal level, a vaccine injury compensation program was recently established to provide no-fault insurance to provide compensation in the case of injury or death arising from the administration of certain childhood vaccines. The program will be funded by an excise tax levied on the covered vaccines; see 42 U.S.C. §300aa-10 et. seq., P.L. 100-203 (1987).Google Scholar
California Health and Safety Code, chap. 1.14, §199-50(n)(3).Google Scholar
See Mariner, Gallo, , supra note 3, for an analysis of the significance of this gap in coverage for manufacturers and for patients.Google Scholar
For example, with widespread inoculation for swine flu, the unexpected incidence of a severe complication known as Guillane-Barré Syndrome was determined to be 1 in 105,000; see Neustadt, Fineberg, , supra note 13 at 100.Google Scholar
See Mariner, Gallo, , supra note 3, for further analysis of this point.Google Scholar
Moran, T., “Products Liability Law and Pharmaceuticals: New Developments and Divergent Trends,” Food, Drug, and Cosmetic Law Journal 43 (Jan. 1988): 33–53. Sometimes, liability judgments can exceed the profit made on a product altogether; see, Bosy, L. “Drug Makers: Courts Treating Us Like Insurers,” American Medical News, Oct. 10, 1986, p. 9.Google Scholar
S. 1220, introduced May 15, 1987. Passage of this bill has been stalled by party and political divisions; see “Congress is Stalemated Over AIDS Epidemic,” Congressional Quarterly December 5, 1987, p. 2986–2988.Google Scholar
Public Health Service Act §408(b), §409(A)(b), as proposed. In a similar vein, Congress recently established the National Vaccine Program directed by a national coordinator and an Advisory Committee, to coordinate the development, distribution, and licensing of vaccines for certain infectious diseases; see 42 U.S.C. §300aa-1, et. seq.Google Scholar
35 U.S.C. §§200-210, and implementing regulations at 37 CFR 401 (1987).Google Scholar
45 CFR §§6-6.4.Google Scholar
49 Fed. Reg. 18900, May 3, 1984.Google Scholar
49 Fed. Reg. 18900, at 18900.Google Scholar
Altman, L.K., “Blood Supply Called Free of AIDS,” The New York Times, August 1, 1985, p. A1.Google Scholar
35 U.S.C. §§200–210. See also Rosenberg, , Patent Law Fundamentals §12, (2d. ed. 1987). Notably, the regulations have rigorous confidentiality requirements to preserve the marketability of a patent for a private firm. The only area in which the government routinely opts to take control of the patent is when national security concerns are involved; see 35 U.S.C. 2 sec. 202(f) and also Rosenberg, , op. cit., at §12.01.Google Scholar
48 Fed. Reg. 16254, April 15, 1983.Google Scholar
35 U.S.C. §203(a)-(d).Google Scholar
S. 1220, introduction.Google Scholar
See Brandt, A.M., No Magic Bullet, New York: Oxford University Press, 1987, for an excellent consideration of the history of venereal disease in the U.S.Google Scholar
S. 1220 §2403(a).Google Scholar
See Eckholm, E., “AIDS Drug Decision is Expected Today,” The New York Times, September 24, 1986, p. A15, and Molotsky, J., “U.S. Approves Drug to Prolong Lives of AIDS Patients,” The New York Times, March 21, 1987, p. A1.Google Scholar
The company maintained that this was in order to free up available AZT supplies for the treatment of patients. See Boffey, P.M., “Experts Find Lag On Testing Drugs in AIDS Patients,” The New York Times, April 12, 1987, p. A1.Google Scholar
Boffey, P.M., supra note 41.Google Scholar
Kennedy, T.E., “Borroughs Wellcome's Efforts to Get Retrovir to AIDS patients” (letter), The New York Times, May 9, 1987, p. A30.Google Scholar
See Neustadt, R. Fineberg, H.V., supra note 13.Google Scholar
See Weinraub, P., “Panel Says New AIDS Drug May Cost Too Much,” The New York Times, March 11, 1987, p. A24. See also Thomas, E.H. Fox, D.M., “The Cost of AZT,” AIDS and Public Policy Journal 2(2): 17–21 (1987).Google Scholar
Even for vaccines not ultimately approved by the FDA, firms can still reap a valuable financial benefit, conducting research and paying overhead at government expense.Google Scholar
See “State Health Department to provide AZT,” The New York Times, July 21, 1987, p. B4; and Foreman, J., “State to Give Anti-AIDS Drug to Needy Patients,” The Boston Globe, December 4, 1987, p. 13; not surprisingly, in Massachusetts, the $728,000 necessary for the program was supplied by a grant from HHS.Google Scholar
“Fund Voted for AIDS Treatment,” The New York Times, May 1, 1987, p. A18.Google Scholar
See Pollack, A., “High Cost of High-Tech Drugs is Protested,” The New York Times, February 9, 1988, p. A1.Google Scholar
See Brandt, A.M., “Polio, Politics, Publicity, and Duplicity: Ethical Aspects in the Development of the Salk Vaccine,” International Journal of Health Services 8(2): 257–270 (1978) for a discussion of the (problematic) role of government intervention in the historical case of the development and trial of the Salk polio vaccine.CrossRefGoogle Scholar