Sunday, March 16, 2014

Truvada: the political pill

Perhaps it is not good form for one bioethics blog to refer to a discussion taking place on another bioethics blog, but this one is hard to resist. Truvada is an antiretroviral drug originally designed for treatment of HIV infection. But a few years ago, studies showed that use of the drug (as 'pre-exposure prophylaxis or PrEP) could help reduce the risk of getting HIV infected among serodiscordant couples, heterosexual men and women, injection drug users, and transgender women and men who have sex with men. The success -- even if it is only partial reduction of risk dependent on appropriate use -- prompted the approval of Truvada for HIV prevention by the FDA and swift action by influential US and international health bodies, such as the World Health Organisation and the US Centers for Disease Control and Prevention, who have released interim guidance on PrEP use.

So what is going on at the Hastings Forum about this? A provocative piece by Richard Weinmeyer entitled "Truvada: No Substitute for Responsible Sex" expresses deep concerns about the use of Truvada by members of the gay community: a 'prevention pill' will lead to reduction of condom use, further spread of HIV, and an erosion of sexual responsibility among gay men that was already happening due to the discovery of effective treatment and the transformation of HIV (in some settings, at least) into a more or less manageable chronic condition. Why, the author opines, can't gay men just use condoms? The choice for Truvada is (he goes on) a choice for personal pleasure above concern for other persons, and should not be condoned. This is technology in service of irresponsibility. And if gay men are not using condoms consistently (he goes on), then they are not likely to use Truvada consistently either. The argument sounds a bit like: you can't give gay men good things.

It is not clear why he singles out gay men (not the only population Truvada might benefit) or why a tool to help in the struggle against HIV/AIDS is trashed before it even gets out the box. That's the thing: Truvada has been approved for use as HIV prevention but has hardly been flying off pharmacy shelves. The allegedly reckless gay community looking for the 'new condom in pill form' haven't showed up. The reasons behind the lukewarm embrace are multiple, including cost issues, lack of an advocacy base and the suspicion that PrEP is just a way of benefiting pharmaceutical companies. In any case, it is worth going over to visit the Hastings Forum and watching the sparks fly.

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Wednesday, March 12, 2014

HIV drugs plus gender inequality equals non-adherence

Initiatives to increase access to essential medicines in developing countries is, of course, a good thing. It is the building of a lifeline. However, in settings challenged by the legacy of colonialism, hampered by unfair trade policies, and marked by poverty and oppression, it is no small feat to get the right drugs to patients and increase the number of patients served. It is a continuous struggle against the obstacles posed by transport and logistics, bureaucratic administrations, weak health care infrastructure, political inertia and the machinations of global pharmaceutical companies. And it is well-known that once the patients finally get the drugs, the struggle is not at all over. There are still problems of 'adherence', which at first sight may look like mere psychological unwillingness or carelessness in regard to compliance with a drug regime. On closer inspection, 'adherence problems' are really problems in integrating the taking of medication within the life-world of the patient. For one or another reason, it does not fit.

I recently saw a striking news item reminding me of the social complexity that stands behind 'non-adherence.' Apparently a significant number of men in Uganda, living with HIV but not open about their status, are taking medications from their HIV-positive female partners. When antiretroviral treatment was first being rolled out in Africa, I recall anecdotal reports of patients sharing their medicines with those without access to treatment. There the motive behind sharing was understandable and admirable -- a matter of human solidarity -- though the practice was dangerous as it meant improper dosing for all involved. The Ugandan case is different: the men probably would have access to treatment if they declared their status and appeared at clinics (apparently this is not just a Ugandan phenomenon). And this is stealing, not sharing, apparently facilitated in some cases by gender-based violence. So this is a new way of being 'non-compliant': having an aggressive partner unable to come to terms with his own HIV diagnosis.  

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Wednesday, February 26, 2014

Ethical argumentation and homosexuality in Africa

I am part of the teaching faculty in a NIH-funded bioethics capacity building program in Cape Town, South Africa, named Advancing Research Ethics in Southern Africa (ARESA). The program targets mid-career health professionals who are liable to contribute to the bioethics culture in their home institutional environment: when serving on their research ethics committees, writing articles, teaching classes, and so on. Part of the bioethics training is in philosophy: after all, bioethics is a form of applied ethics, and ethics is a central branch of philosophy. This means that critical thinking and argumentation are core skills for those in the field: when moral claims are made, bioethicists are supposed to examine and evaluate the ethical reasons that support them.

In principle, the idea of philosophical argumentation is not difficult to convey. But in my experience, sympathy towards the practice depends what specific claim is being examined. Predictably, the holier the cow, the greater the reluctance. Examining the moral claims "Homosexuality is immoral" and/or "Homosexuality should be illegal", in the African context, seems to be even harder than exploring the reasons against abortion. This is unfortunate, given the topicality of the moral and legal status of homosexuality, now that Ugandan President Museveni has recently signed anti-gay legislation. It is also unfortunate given the painfully low quality of the debate. It is just supposed to be obvious why homosexuality is wrong, dangerous, to be outlawed. If you ask for reasons, the responses are not promising.

Case in point. Take this editorial in The Observer, a prominent newspaper in Kampala, Uganda. Entitled "Uganda must resist resist West on anti-gay legislation." The 'must' indicates that a normative claim is being made, i.e. that there are good reasons for laws against homosexuality in Uganda. So what good reasons are offered? Let me sum them up:

  • A book written back in 1989 set out a six-point plan to promote the rights of same-sex persons. According to conservative groups in the USA, the book initiated an agenda in which anti-gay legislation is packaged as an affront in terms of human rights, justice, and freedom.
  • Gay groups use scientific research to prove that homosexuality is innate, and some gay people claim to know they were gay at the age of five, which is ridiculous. 
  • Gay groups claim that all dissent against their views is homophobia. 
  • All religious denominations in Uganda say that homosexuality is abominable, detestable, repugnant and offends God. 
When potential harm is connected to a moral claim, then the arguments in support of that claim should be very robust. Given that anti-gay legislation means prison for sexual orientation -- not to mention encouragement of anti-gay 'street justice' when names of gay persons are published -- the standards for rational justification should be high. Suggestions of that the global rise of gay rights is due to a 'roadmap' in an obscure book does not do it; if scientific research on homosexuality is dubious, that should be argued for, not insinuated; the weaknesses of (selectively) using holy scripture to support moral claims are well-known. This is just one editorial (by a lecturer at a higher education institution in Uganda), but there is a pattern. Backed against a wall, those in Africa in favor of outlawing homosexuality are asked to give reasons, and then out comes everything and the kitchen sink. Except good arguments. And when you are violently opposed to homosexuality, without being able to give good reasons, then homophobia might just be the best explanation of what you are doing. When will the Ugandan bioethicists rise up and start a meaningful debate? 

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Saturday, February 01, 2014

The unbearable lightness of commitments to diseases of the poor

AstraZeneca, Britain's second largest pharmaceutical company, has closed down its research and development site in India as it has decided to stop research activities into neglected, tropical diseases. This despite the company having pledged (not particularly bindingly) to contribute financially and otherwise to the control of such diseases by 2020, along with government aid agencies, the Bill and Melinda Gates Foundation, and 13 other pharmaceutical companies. The motivation for the decision is overwhelmingly economic: AstraZeneca shares have been losing value over the past while, and neglected tropical diseases are no money makers, to the contrary: those mostly likely to need treatment for such diseases are the least likely to be able to pay for them.

The pullout of AstraZeneca will only reinforce skepticism regarding the commitments of pharmaceutical companies towards neglected diseases. To what extent are these commitments genuine and to be taken seriously? To what extent are they public relations strategies to be abandoned as soon as they cut too far into the bottom line?  

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Friday, January 10, 2014

Minimizing exploitation of developing world researchers

When many people think of research ethics, they naturally think of issues surrounding the treatment of research participants by researchers. Are the latter harming the former, deceiving them, exploiting them? Just as it has taken a long time to understand medical ethics as involving something beyond the physician/patient relationship, it has taken some time to conceive research ethics as the study of the ethical issues involved in the whole research enterprise, from the 'micro' level of the consent process to the 'macro' level of research funding priorities or the geopolitics of global health research.

It is refreshing for this reason to see a short piece in Nature Medicine on the issue of the exploitation of health researchers in developing countries. The involvement of local collaborators in research conducted in the developing world is commonly regarded as ethically optional. And there is data to support claims that developing world researchers, when they are involved in research projects (sponsored and commonly driven by external agencies and investigators), often are not named as co-authors of articles publishing the results. To put it brutally, local researchers are typically considered good enough to recruit participants, to collect data, to act as diplomats with local institutions, and to sell the study to local communities. They are implicitly regarded, much of the time, as not good enough to design studies, act as principal investigators or be first authors on research articles. Those privileges go preponderantly to outside researchers from more powerful institutions and nations. So not only research participants in developing countries stand to be exploited in global health research: local researchers may also appear as 'vulnerable populations' in this sense.

Shuchman et. al. offer a number of mechanisms to minimize this form of exploitation. They argue that the WHO should take the lead in urging journals to require local authorship, and for research ethics committees to consider local research collaboration as a component of what constitutes ethical research. More than another code of conduct of scientists is needed. But I think the roots of this problems lie much deeper. Global political, social and economic disparities boil down to weak research and education infrastructures in developing countries. It is fine in practice to say that local researchers should be treated as equals, but if the latter have not had the same resources or opportunities, it is very hard for them to perform as equals. It may also be hard to them to perform as equals when their developed world collaborators are their bosses, or at least those who manage the pursestrings. The situation is made more complex when publication of scientific articles do not have the same weight in all cultural contexts. In countries like the USA, peer-reviewed articles are the coin of the realm, and your promotion and tenure relies heavily on your publication record. But this inordinate stress on publication for career development is not the case everywhere. In short, while the goal is a worthy one, the obstacles to researchers in collaborative global health research being genuine equals can sometimes be quite daunting.

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Saturday, December 21, 2013

Responding to emergencies and sharing data

Responding to emergencies is the vital stuff of television and film. Persons are in distress, injured, diseased: there is a natural disaster, an epidemic outbreak, a civil war, a nuclear event. Professionals of all stripes come to their aid, sometimes taking on substantial risks to their own well-being. Both heroic success and tragic failure in this domain rarely fail to generate human interest. Whereas data sharing ... is the sharing of data. It just doesn't generate that kind of excitement. Researchers or research agencies collect data. After they collect it, they may share datasets with others (other research institutions, governments, and so on) in order to spread scientific knowledge, stimulate further research, and perhaps improve the lot of humanity somewhere down the line. What happens when the excitement of emergency response meets the mundaneness of data sharing?

Apparently, Medecins Sans Frontieres (MSF) is what happens.  MSF -- a Nobel prizewinning humanitarian organization -- collects data on the people they are assisting in the many emergencies they are engaged in. Not that this is a bad thing: some of the data collection (on routine medical procedures, adherence to treatments, etc.) are primarily for quality control purposes, and MSF also conducts operational research among groups affected by neglected diseases in impoverished countries. But data collecting in times of crisis leads to an ethical challenge: on the one hand, if the data collected could be used in beneficial ways by other researchers or agencies, it ought to be shared. On the other hand, the kinds of data collected in extreme circumstances (think sexual violence in the Democratic Republic of Congo or injection drug use in Thailand) is sensitive and could harm already vulnerable populations if it is not handled appropriately.

A recent article in PLoS Medicine by the former MSF International President Unni Karunakara describes how the organization developed a policy to resolve these ethical tensions.  Much of it seems sensible and thoughtful, but one point might raise eyebrows. By sensitive data, MSF understands " ... any subset of data that could be misused against the interests of individuals whose data is included in the dataset or against MSF, or put either individuals or MSF at risk for political, financial, or other reasons." Apparently if MSF determines that the risk to its own organization is too high, then it will not share a dataset with others. But what if access to that 'MSF-compromising' dataset might benefit communities? I have pointed out elsewhere that MSF zealously protects its own reputation, sometimes at the expense of faithful disclosure of its own practices. Keeping a positive public relations profile is important for an organization largely dependent on donor contributions. Hopefully the tendency towards self-protection will not have an adverse impact on its data sharing practices.

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Saturday, November 16, 2013

A tale of two bioethics journals

I did something probably not conducive to mental health: I looked at the American Journal of Bioethics and the Indian Journal of Medical Ethics during the same evening. The current issue of the American Journal of Bioethics, whose blog has a motto that wears its ambition on its sleeve ('Where the World Finds Bioethics') is all about advances in neuroscience and psychopharmacology that could lead to the control of 'bad' forms of love. Of course, we do not have the scientific capacity to actually do this, but why not speculate about the ethical implications of emotional enhancements anyway? True enough, even if anti-love pills are a far way off, the thought experiment might help us understand a bit better what that phenomenon called 'love' is all about. Love is important. Still, the debate gives something of a rarified, parlor game feel, especially in a world where millions do not have access to immunological enhancements (like antibiotics) or nephrological enhancements (like dialysis).  

The Indian Journal of Medical Ethics is tackling quite another kettle of fish, very much non-speculative in character. Researchers conducted a randomized placebo controlled trial of cervical cancer diagnostics in India, despite (a) the intervention being tested already widely being regarded as efficacious, and certainly more effective than no screening at all and (b) despite the possibility of testing their hypothesis by using an existing diagnostic (Pap smear) as comparator.  For a decade, some 76,000 Indian women were monitored (apparently including monitoring of the growth of their cervical cancer) but allegedly did not receive sufficient information regarding alternatives to screening and did not adequately consent to the study. It is said that over the years, 6.5 more women died in the control group from cervical cancer than the intervention group. The ethics of this study is what the current issue of the IJME is debating, with scientists defending it, and journalists and ethicists criticizing it.

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