Letter in Science Magazine on Ethics of Studies on AZT and Needle Exchange

This letter, by Health Research Group Deputy Director Peter Lurie, M.D., MPH, and Director Sidney Wolfe, M.D., appeared in Science on July 2, 1999.

We invoked the Tuskegee study analogy in the perinatal AZT trials because (i) both were prospective studies in which participants were denied known effective treatments; (ii) both were conducted or funded by the U.S. Public Health Service; (iii) both involved people of color; (iv) both included violations of informed consent[1]; (v) both were justified by claiming that this was the only appropriate study design; (vi) both were defended by positing differences between previous and present study populations; (vii) both were justified by asserting that study participants would not have been treated anyway; and (viii) both were terminated only after exposure in the lay press.

The Alaska needle exchange study meets criteria (i), (ii), (iv), (v), and (vii) [2]. Unlike all other needle exchanges, to our knowledge, drug injectors not enrolled in the study cannot use the needle exchange. Drug injectors in the study are provided identification cards and randomized to use the needle exchange or to receive a bus map of Anchorage with pharmacies identified; they are also instructed how to talk and dress in order to convince a pharmacist to sell them a syringe, a violation of local Anchorage law [3]. (Fairchild and Bayer note only that pharmacy sales are legal in the state of Alaska.) When a study participant presents himself or herself at the needle exchange, a card reader produces the person's image on a computer screen and instructs the staff person whether to admit the drug user. If someone randomly assigned to not use the needle exchange attempts to do so, he or she is turned away from the needle exchange and provided the map.

Certainly there are differences between these unethical studies and Tuskegee. But the dictionary defines an analogy as "a likeness in one or more ways between things otherwise unlike" [4]. Tragically, these studies are similar to Tuskegee in more than enough ways to justify the analogy.


References

[1] H. W. French, New York Times, 9 October 1997, p. A 1.

[2] P. Lurie; Am. J. Epidemiol.149, 715 (1998).

[3] I. 0. Gostin, Z. Lazzarini, T. 5 Jones, K.Flaherty, J. Am.Med. Assoc. 277, 53 (1997).

[4] Merriam-Webster Dictionary (Merriam-Webster, Springfield, MA, 1997).