Monday, July 26, 2010

Ethics After an HIV Trial

Today the New York Times has an article about what appears to be the first successful "microbicide" that protects against HIV infection in women. Many hosannahs have been said in the medical & scientific research circles following the release of this data. No less an authority than Anthony Fauci, the head of the National Institute of Allergic and Infectious Diseases (and someone Billy thinks of as a patron saint of the profession), noted, "there’s a certain feeling of ease and pleasure for me as a scientist that any way you slice the data, it’s statistically significant." That may not sound like much, but in doctor-speak that's a pretty excited endorsement.

The "microbicide" is a vaginal gel that the woman applies both before and after having sex, and it provided protection between about 40 and 50 percent of the time (the amount varies because the researchers broke down the cohort into sub-groups based on how faithfully they applied the gel; the more faithful users, not altogether surprisingly, were better protected). That's it--the gel hardly constitutes complete protection, but previous studies have shown dismal results.

You might be tempted to ask about condoms: why not just use them? Aren't they much more effective? This depends on how you mean "effective." If you actually use a condom, then yes, it's in fact a very effective means of protection for both partners. The problem is most men, whether they're having sex with other men or with women, don't like condoms and try to avoid using them at all costs. (I'm certainly no fan of them.) So out in the real world, where the vast majority of people aren't enrolled in a clinical trial, a condom isn't actually especially effective, because it often remains on the shelf, or in the purse, or in someone's back pocket, sometimes with the owner having the best of intentions, or as the case may be, because one partner persuaded the other not to use it (regardless if the sex is "gay" or "straight"). So the gel can provide extra protection for a woman who has a partner or partners unwilling to wear The Sock. (There's some very preliminary data suggesting the gel may be protective for men in anal intercourse, but this study looked exclusively at women.)

The trial enrolled nearly 900 African women. Now, however, the trial is over. The study was funded largely by the US Government. The question is, what is the obligation that the researchers, backed by the US, have to the patients? Is it ethical to simply walk away from these patients and allow them to be at "baseline" risk of acquiring the virus--which is still largely a death sentence in Africa? Or are the researchers only obliged to enter into an agreement which ceases to be at the end of the trial? These women, after all, would mostly have become infected had they not enrolled in the trial. On the other hand, what if a microbicide is developed as a result of this trial and becomes available outside of Africa first? Does that seem fair? Shouldn't the women who "put their bodies on the line for this study" (in the words of AIDS activist Mark Harrington, quoted in the article) have first dibs on the gel?

These are not idle questions and such situations have occurred many times throughout the past 60-70 years in US medical research. Most readers will be familiar with the infamous Tuskeegee Experiment, but many other similar experiments have taken place precisely because nobody designing the trial took the kind of questions above into account. I don't mean to imply that these researchers didn't; I can only say I am concerned by the Times report. In my own field, the "intervention" we study is almost always a vaccine, and if that works you don't need to come back for more; this situation is different.

Typically, the Billy Rubin Blog tries to leave you with an opinion. Tonight I only have questions--those questions two paragraphs above, in addition to more in that vein running through my head right now--and can leave you only with a troubled shrug of my shoulders.

No comments:

Post a Comment