Abstract
This paper looks at some of the ethical concerns regarding a recent application to the U.S. Food and Drug Administration (FDA) for approval of the sale of HIV tests over-the-counter (OTC) directly to consumers. The concept of at-home HIV testing is not new, but OraSure Technologies Inc., a U.S. manufacturer of rapid HIV tests, is now seeking FDA approval to take at-home testing one step further to enable consumers to test themselves and interpret the results without the assistance of an outside party. This paper reviews some of the purported benefits and potential risks of at-home HIV testing, and looks at the way one Canadian company is attempting to address the potential risks. In doing so, this paper brings to the fore concerns regarding corporate involvement in the regulatory approval of biotech products.
Similar content being viewed by others
References
Bayer R., Stryker J., Smith M. D. (1995). Testing for HIV Infection at Home. The New England Journal of Medicine, 332(19):1295–1299
BPAC: 2005, ‚Quick Minutes 85th Meeting – Nov 3–4, 2005’, Retrieved February 21, 2006, from http://www.fda.gov/ohrms/dockets/ac/05/minutes/2005-4190M1_quick%20minutes.htm
Canadian HIV/AIDS Legal Network: 2001a, HIV Testing Info Sheet #11: Home Testing. Retrieved December 7, 2005 from http://www.aidslaw.ca/Maincontent/issues/testing/e-info-ta11.pdf
Canadian HIV/AIDS Legal Network: 2001b, HIV Testing Info Sheet #18: Partner Notification. Retrieved February 21, 2006, from http://www.aidslaw.ca/Maincontent/issues/testing/e-info-ta18.htm
Carpenter, D., M. Chernew, D.G. Smith and A.M. Fendrick: 2003, ‚Approval Times for New Drugs: Does the Source of Funding for FDA Staff Matter?’, Health Affairs, W618–624
The Economist (2004) Business: From Bad to Awful. The Pharmaceuticals Industry. 272(8403):80
Eaton M. (2004). Ethics and the Business of Bioscience. Stanford, Stanford University Press
Ferrera, J. (1998, September/October). “Revolving Doors: Monsanto and the Regulators”. The Ecologist 28, 5
Frerichs, R.: 1996, ‚Home HIV Screening Debate’, in: XI International Conference on AIDS, Vancouver, Canada, 8 July 1996. Retrieved March 5, 2006, from http://www.ph.ucla.edu/EPI/faculty/frerichs/debate.html
Gilding M. (2004) DNA paternity testing without the knowledge or consent of the mother: New technology, new choices, new debates. Family Matters 68:68–75
Gollust S. E., Hull S. C., Wilfond B. S. (2002) Limitations of direct-to-consumer advertising for clinical genetic testing. Journal of the American Medical Association, 288:1762–1767
Gollust S. E., Hull S. C., Wilfond B. S. (2003) Direct-to-consumer sales of genetic services on the Internet. Genetics in Medicine 5(4):332–337
Harris, G.: 2005, October 13, ‚F.D.A. to Weigh At-Home Testing for AIDS Virus’, New York Times
Lewis C. (2001) Home Diagnostic Tests: The Ultimate House Call? FDA Consumer Magazine 35:18–22
Leland, J.: 2005, November 5, ‚U.S. Weighs Whether to Open an Era of Rapid H.I.V. Detection in the Home’, New York Times
McCabe L. L., McCabe E. R. B. (2004) Direct-to-consumer genetic testing: Access and marketing. Genetics in Medicine 6(1):58–59
MedMira: 2005, ‚Over-the-Counter HIV Testing: A Consumer Advocate Strategy’, Presentation to the Blood Products Advisory Committee November 3, 2005. Retrieved February 23, 2006, from http://www.fda.gov/ohrms/dockets/ac/05/slides/5-4190ws1_1.htm
Merson, M.: 1996, ‚Home HIV Screening Debate’, XI International Conference on AIDS, Vancouver, Canada, 8 July 1996. Retrieved March 5, 2006, from http://www.ph.ucla.edu/EPI/faculty/frerichs/debate.html
Metzler, N.: 2005, October 25, ‚Advisory Committee to Review OTC HIV Test’, PharmaExec
Miller H. I. (1999) The Real Curse of Frankenfoods. Nature Biotechnology, 17(2):113
Miller, J.: 2003, Beyond Biotechnology: FDA Regulation of Nanomedicine. The Columbia Science and Technology Law Review, Vol. IV. Retrieved February 15, 2006, from http://www.stlr.org/html/volume4/miller.pdf
Newell, P. and D. Glover: 2003, ‚Business and Biotechnology: Regulation and the Politics of Influence’, IDS Working Paper 192, Biotechnology Policy Series No.17, July 2003 (IDS, Brighton)
Newell, P. and D. Glover: 2004, ‚Business and Biotechnology: Regulation of GM Crops and the Politics of Influence’, in K. Jansen and S. Vellema (eds.), Agribusiness and Society: Corporate Responses to Environmentalism, Market Opportunities and Public Regulation (Zed Books, London), pp. 200–231
Olson, M. K.: 2003, (Jul–Dec) ‚Explaining Reductions in FDA Drug Review Times: PDUFA Matters’, Health Affairs, S1–S2
Schopper, D.: 1996, ‚Home HIV Screening Debate’, XI International Conference on AIDS, Vancouver, Canada, 8 July 1996. Retrieved March 5, 2006, from http://www.ph.ucla.edu/EPI/faculty/frerichs/debate.html
Skolnik et al. (2001) Deciding Where and How to Be Tested for HIV: What Matters Most? JAIDS Journal of Acquired Immune Deficiency Syndromes, 27(3):292–300
Spielberg et al. (2001). Moving from Apprehension to Action: HIV Counseling and Testing Preferences in three at-risk Populations. AIDS Education and Prevention, 13(6):524–540
San Francisco AIDS Foundation: 2005, ‚Testimony before the Blood Products Safety Advisory Committee’, November 3, 2005. Retrieved February 21, 2006, from http://www.fda.gov/ohrms/dockets/ac/05/slides/5-4190ws1_1.htm
Who’s Positive: 2005, ‚Who’s Positive to support Over-the-Counter (OTC) Rapid Home-Use HIV Test Kits to The Blood Products Advisory Committee’, Press Information. Retrieved January 31, 2006, from http://www.whospositive.org/news/news.php?newsid=20
William-Jones B. (1999). Re-Framing the Discussion: Commercial Genetic Testing in Canada. Health Law Journal 7:49–67
Williams-Jones B. (2003). Where There’s a Web, There’s a Way: Commercial Genetic Testing and the Internet. Community Genetics 6(1):46–57
Acknowledgments
The author would like to acknowledge that this research was supported in part by funding granted to Prof. Chris MacDonald by the Canadian Institutes of Health Research (CIHR). The author also wishes to thank Giles Crouch for his valuable insight into the HIV-testing industry, as well as Chris MacDonald and two anonymous reviewers for their thoughtful comments and suggestions.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Whellams, M. The Approval of Over-the-Counter HIV Tests: Playing Fair When Making the Rules. J Bus Ethics 77, 5–15 (2008). https://doi.org/10.1007/s10551-006-9300-5
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10551-006-9300-5