Tuesday, November 30, 2010

HIV & the Ethics of Human Research

My friend Shar and another friend of hers brought up some excellent questions regarding my last post.  They wanted to know more about the methods used in the HIV prevention study and specifically about the ethical issues involved.  I was going to respond with just a comment, but it actually deserves its own post.  The ethics behind such studies are critically important.  And science has a pretty shameful history when it comes to things like this.  But fortunately the recent news about Truvada comes from a very responsibly-conducted study.  This is a good opportunity for me to talk about the three fundamental ethical principles for human research, outlined in the famous Belmont Report.  I'll try to use specifics from the HIV study to explain each of these principles: Respect, Beneficence, and Justice. 
The infamous Tuskegee syphilis experiment.  Unethical in every sense: deceptive & lacking informed consent, deliberately harmful, and exploitative of disadvantaged populations.  (image from wikipedia)
1. Respect
Researchers must respect people's autonomy and right to the truth.  A key part of this principle is informed consent.  I'm happy to say that all of the subjects in the HIV Truvada study were absolutely 100% aware of what was going on.  This was a multinational study carried out in six different countries over a three-year period.  The subjects were 2,499 "high risk" individuals, meaning gay men and transgender women who frequently had unprotected sex.  All of them enrolled voluntarily, and the only information withheld was which pill they would receive - Truvada or placebo. 

2. Beneficence
Based on the Hippocratic oath to "do no harm," great care should be taken to minimize risks to subjects and maximize benefits.  In particular, when testing out a new treatment for a disease, the "control" group must receive the best standard treatment that's already in use.  For the Truvada study, the control group just received placebo since there was no existing preventative medication for HIV.  But there are of course other ways to prevent HIV infection.  So all of the subject received the current best preventative measure: a "comprehensive package of preventative services."  This meant HIV testing, condoms, treatment of sexually transmitted infections, and intensive risk-reduction counseling.  In spite of these efforts, 100 of the 2,499 subjects in the study contracted HIV (determined by monthly blood tests).  But the researchers did everything in their power to help all participants avoid HIV infection.

(A related side note:  Many people have expressed concern that a preventative medicine will cause an increase in risky behavior.  This remains to be seen, but so far it's doesn't seem to be true.  The men participating in the study, who were all receiving behavioral counseling, actually used condoms more frequently and had fewer partners.)

3. Justice
This addresses the questions of who benefits from the research and who bears the costs.  For the case of the Truvada study, I think an important issue is not so much with the research itself but with its implications.  This was a global study, and ideally it should help people all over the world.  But right now Truvada can be prohibitively expensive.  In the U.S, the cost is somewhere around $10,000 per year.  However, generic versions of the drug are available in third world countries for as low as $0.40 per pill.  Whether or not government subsidies and mass-production of generics could help lower the cost everywhere remains an open question at this point.  As for access, there are many organizations working to get these medications to the people that need them worldwide (see below).  And they've made great progress.  Such efforts have been ongoing and include distribution of Truvada's generic equivalent, which is already widely used for HIV treatment (but not prevention yet).  So the issues of justice arising from new information like the Truvada results are clearly important, and they're far from being resolved.  But with informed, compassionate people working together based on rigorous results from ethically-sound studies, we can keep moving forward.

Justice through universal access. This video is from AVERT, a major international organization fighting HIV/AIDS.  [Special note: tomorrow is World AIDS Day 2010. Get informed & get involved!]

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