Tuesday, July 31, 2012

Forced sterilization in Namibia, criminalizing HIV infection in Zimbabwe

Bioethics culture in Africa is nascent. There are ethical dilemmas in research, public health and medical practice in Africa like there is no tomorrow, but explicit discussion in the press, teaching about bioethics issues in medical schools, public debate about the ethics of health policies ... not so much. That is why it is sometimes helpful to have African courts play the unintended role of bioethics catalyst. This week's news has a couple of juicy legal stories with ethical overtones. In Namibia, the High Court in Windhoek ruled that three women were sterilized without their informed consent, and the women will be given as-yet-to-be-determined damages. According to their lawyers, the women presented at government clinics in order to deliver their babies by caesarean section, and the government doctors said they would only be eligible for the surgery if they agreed to be sterilized at the same time. The judge sensibly ruled that the sterilization was coercive and that the women were not in a position to give free and informed consent. The judge, however, did not rule that the government doctors acted in this way because all three women were HIV positive. HIV rights groups and human rights activists contend that forced sterilization of HIV-positive women is by no means uncommon in Africa, so this court case might be the first in a long, pan-African series. It would be nice if this case and others like it raised the profile of informed consent in African medicine, and poke a few holes in the reigning medical paternalism, particularly as this relates to female patients.

Speaking of HIV and courts. A woman has been found guilty of infecting her husband with HIV in Zimbabwe. Zimbabwean Criminal Law Act (Section 79) has this dubious little chunk of legislation:

Any person who: (a) Knowing that he or she is infected with HIV; or (b) Realising that there is a real risk or possibility that he or she is infected with HIV; (c) Intentionally does anything or permits the doing of anything which he or she knows will infect, or does anything which he or she realises involves a real risk or possibility of infecting another person with HIV, shall be guilty of deliberate transmission of HIV, whether or not he or she is married to that other person, and shall be liable to imprisonment for a period not exceeding 20 years.

Samukeliso Mlilo finds herself on the wrong end of this elastically phrased law, even though it is uncertain whether she infected her partner or the other way around. Which would seem to matter. A Zimbabwean man accused of intentionally infecting his partner had better luck: he was acquitted by his (wonderfully named) lawyer,  Clever Tsikwa. When charged under Section 79, perhaps it helps if your lawyer is clever, or if you are a dude.

Thursday, July 26, 2012

Truvada: pushing the envelope or jumping the gun?

A few days ago, the Food and Drug Administration (FDA) did something that has perhaps not garnered sufficient attention among those working in bioethics. The FDA namely approved the use of the antiretroviral Truvada for use as pre-exposure prophylaxis to reduce risk getting HIV via sexual intercourse. Basically, it is like taking a pill to reduce the risk of acquiring malaria when traveling to a malaria endemic zone. Sort of. What complicates matters is that sex with other human beings is involved rather than contact with mosquitos. And HIV, unlike malaria, is incurable and a stigmatized disease. But perhaps for the moment the real difference is: we have a pretty good idea of what happens when people take malaria prophylaxis, but we do not have a very good idea of what will happen when Truvada starts being prescribed by doctors.

Now you would think that the evidence base must be quite strong before FDA would approve a 'biomedical condom', so to speak. But that is not really the case. There were a couple of randomized controlled trials that indicated a reduction in risk via sexual activity if you took the active ingredients in Truvada (emtricabine/tenofovir) daily: a 42% reduction among men who have sex with men (the iPrEx study) and a 75% reduction among serodiscordant heterosexual couples (the Partners PreP study). But overall, the scientific evidence base for HIV preexposure prophylaxis is currently murky: two other large scale studies in Africa (FEM-PreP and VOICE) recently showed no reduction of risk when using the same drug combination.

But the FDA approved Truvada for use among adults at high HIV risk exposure anyway. Compare: male circumcision as HIV prevention approach was only approved by official agencies in the US after two decades of observational studies and three randomized controlled trials that all indicated (to roughly the same degree) that being circumcised significantly reduces the risk of males acquiring HIV from their female partners. Then again, circumcision is not a pill and cannot be patented. Let me put it plainly: the low scientific bar for Truvada's approval feeds conspiracy theories about pharmaceutical companies and the FDA: the potential global market for 'a pill that protects against HIV' is huge. Is the FDA just facilitating an American company looking to gain early market advantage, while deviating from its stated mission to protect public health?

In any case, it is sobering to see studies being presented at the ongoing International AIDS Conference in Washington -- such as research on attitudes towards preexposure prophylaxis and sexual risk behavior among men who have sex with men -- that ought to have informed regulators before Truvada was approved.

Wednesday, July 18, 2012

Research ethics, global inequalities and KEMRI

Research ethics is typically focused on the relationship between researchers and research participants. When research takes place in developing countries, and the funding for the research (and many of the researchers) comes from more affluent nations of the world, there are the usual ethical concerns about exploitation: who will profit (more) from the research? Will the local community see anything of the benefits that might arise from the scientific activity? These are 'normal' ethical challenges when doing research in a starkly unequal world.

But the same tensions often arise among research team members themselves. Global health research in developing countries generally involve foreign and local researchers. The foreign researchers often enjoy the privilege of having been educated in more favorable circumstances: not just their tertiary education, but from primary school onward. They are often embedded in established scientific networks, connected to important individuals and institutions, and have a track record of successful grant writing and publications. Local investigators are often in a disadvantage in these important respects, and may find themselves in a relationship of unequal power with their foreign colleagues. They may, for example, not be fully involved in the initial design of a scientific protocol; a frequent complaint that I have heard is that foreign researchers and institutions come into the field with an already finalized protocol, leaving local investigators in the uncreative and disempowering position of mere implementers.

Last week, Nature published a report of a dispute between the Kenya Medical Research Institute (KEMRI) and some of its former Kenyan researchers which brings these common tensions into sharp relief. According to the researchers' complaints, they were passed over for promotion, training opportunities and grants in favor of their white foreign counterparts.  They also allege that some of their work was stolen from them and given to foreign colleagues, and that they were paid less than foreign colleagues despite having equivalent qualifications. KEMRI denies all these allegations, and the dispute is being heard by the Kenyan High Court.

Friday, July 13, 2012

Control your population

The New York Times reports a study by researchers at John Hopkins University that indicates maternal mortality could be slashed by nearly a third if women had greater access to contraception. Giving birth, as is known, can be a very dangerous activity in resource-poor settings. Of course, maternal mortality is just the indicator of choice here: adequate access to contraception is likely to have other benefits for the women besides lowering their risk of premature death, as well as avoiding the negative impacts of overpopulation for the local economy and environment. The issue of family planning, it seems, is coming back on the radar after being eclipsed by the rise of HIV/AIDS; as funding for HIV/AIDS has risen, funding for family planning has plummeted. The Gates Foundation, for one, is backing family planning initiatives, including the recent London Summit on Family Planning in which global leaders and institutions pledged to provide voluntary family planning services to an additional 120 million women in the world's poorest countries.

There is something ironic about family planning initiatives funded/led by developed, affluent countries that are directed at less affluent, developing ones. Family planning is a worthy objective that is politically and culturally touchy, everywhere. In the United States, there was much controversy this year about whether President Obama's Patient Protection and Affordable Care Act involved forcing religious institutions to provide health care insurance that included coverage for contraception. There is the ongoing legal and ethical debate about whether pharmacists can refuse to dispense emergency contraception (Plan B) on religious grounds. Then there are the ongoing battles about the content of sex education in US schools. So one can hope that these large-scale family planning initiatives aiming at low-resource countries will go beyond the biomedical perspective, and develop creative, locally-driven, culturally sensitive, politically savvy and women-empowering ways to control the rate of births. One can also hope that if that happens, the lessons learned can be brought back to bear on the developed world, since it is a call for progressive social change.