Beware of pharmaceutical companies bearing cheap drugs

Pharmaceutical companies are for-profit enterprises that make their money by selling medicinal drugs. This might seem stupefyingly obvious, but it can get (briefly) obscured when these companies distribute shiny pamphlets suggesting that the promotion of human well-being is their ultimate mission or when they act in seemingly philanthropic ways. Scratch the surface, or just wait until the smoke clears, and the profit motive comes back into view. This is partly why bioethics workers find pharmaceutical companies fascinating and appalling: sometimes they offer a glimpse of what it would be like if powerful multinationals really threw their weight behind public health goals, but only a glimpse, because they inevitably veer off to make money and please their stockholders, sometimes in ways at odds with the ethics of research and health care. They are a kind of ethical rogue element. We need them -- who can whip up their own Klonopin? -- but don't expect them to join your health and social justice parade.

The New York Times published a piece last week about two multinational drug companies, Pfizer and Cipla, who have made an agreement to charge low prices for 16 common chemotherapy drugs. In addition, specialists from American cancer hospitals are helping to set up a digital repository of clinical oncology guidelines (to be incorporated by IRB into their Watson program) to help doctors hone in on the right medical approach. This initiative is welcome news to health systems and patients in the developing world, because of the gradual epidemiological transition taking place there from infectious disease (HIV, tuberculosis ...) to non-communicable disease (especially cancer). In sub-Saharan Africa, current access to cancer drugs and adequate cancer care is, with some exceptions, flat-out terrible. Any improvement in cancer care could be lifesaving. Just as the lowering of HIV drug prices by big pharma, back in the 1990's, was lifesaving for many.

Here come the caveats. Prices for HIV drugs were lowered by the work of advocates, which the pharmaceutical industry initially opposed tooth and nail. (They have reaped profits from antiretrovirals in the meantime.) While lowering drug prices did make a significant difference for patient care, only 50% of those in sub-Saharan Africa currently in need of HIV drugs are on treatment, two decades later. Much more is needed than lowered drug prices to improve patient and population health. More too than the establishment of an oncology database, particularly if what the guidelines recommend implies human or material resources that are not locally available -- the guidelines could be a grim reminder of what you don't have. And the use of IBM's Watson for clinical care has not been a rousing success so far even in the best of circumstances.

Most likely, this initiative will help some people, but less than the early hopes and the hype might indicate. The pharmaceutical companies involved will gain from product visibility and may have a competitive advantage as the African population grows older, cancer prevalence rises and if the economies (and consumer buying power) of African countries strengthen. This may be the long game for them, and could help explain why -- long after these chemotherapy drugs were developed -- they are being offered more cheaply to African countries now.

Trying to look on the bright side of colonialism

There has been a big flap this week about an article published in Third World Quarterly entitled 'The Case for Colonialism' by Bruce Gilley at Portland State University. The controversy seemingly revolves around how the article was published by the journal's editor despite having been rejected by its reviewers, i.e. a violation of the peer review process. But, of course, the complaints are not purely about the process of the paper coming to light: after all, the author is arguing that colonialism was largely a good thing, and we should have more of it. There would be much less political buzz if the journal's editor had, over the objections of reviewers, approved a paper called 'The Case Against Colonialism.'

As for the paper itself, it is something of a train wreck, and there is a strong case for thinking the reviewers (whose reviews are apparently under lock and key) were right. Gilley maps out a series of epistemic virtues (non-biased data and case selection, internal coherence, falsifiability of claims), which he uses to criticize those opposed to colonialism. In the course of building his own argument, however, he violates all of them, and how. You could base a drinking game on how many times he hoists himself on his own petard. Just one example: Gilley claims that colonialism had 'subjective legitimacy' because, he writes, the colonized populations generally approved of colonial powers and governance. His 'data' for this sweeping claim throughout the paper largely comes in the form of journalistic impressions and anecdotal remarks. This is not the worst of it. As others have pointed out, the most damning problem with the article is his relentless cherry-picking of benefits from colonial rule together with a complete disregard for the long-term and widespread damage colonial rule caused or the self-serving and usually racist motivations behind it. It does not take much effort to see the piece, particularly in the current US political climate, as historical revisionism in the service of white supremacy. No doubt defenders of such views will object that academia should be open to 'alternative voices' in the name of the First Amendment. But academic journals have no obligation to be open to crappy papers.

What could have been more interesting, instead of making a case for colonialism, is a critical analysis of the myriad ways former colonies grapple with the legacies of colonialism, since they are typically unable to fully embrace or reject them. Whatever 'benefits' might be attributed to colonialism cannot be disentangled from harms and violations; there are no real concepts to faithfully describe this. Tainted benefits? Abuses with an upside? When you drive the N1 out of Cape Town in South Africa, you are enjoying one of the best highways in Africa. You are also 'enjoying' the fruits of the Apartheid system, built by cheap labor, and as you drive, you can see townships where populations of non-whites were dumped and continue to experience the effects of political oppression. Reading Gilley is like hearing someone say: "Get over it. Don't you see you have a highway? So blind, so ungrateful."

Is there a link here to bioethics? I think so. Bioethics workers in developing countries are in a similarly uncomfortable position of being unable to fully reject assumptions, preoccupations and frameworks originating from the richer countries of the north, but also unable to fully embrace them without losing touch with (and being useful for) their own local context. The decolonization of bioethics in Africa, whose shape is hard to discern, will be a long work in progress.

Bringing good things to life? GE in Africa

When I am looking for information about health in developing countries that is not available in the usual media outlets, covering stories less spectacular than the outbreak of the latest infectious threat, I have sometimes turned to AllAfrica.com. Certainly in the past, you could find issues related to bioethics of regional and local concern, say nurses strikes or clean water insecurity. Turning to AllAfrica.com for the first time in awhile, and wandering over to the fancier-looking Health webpage, my eye fell on an article entitled "Our Generation Will See Healthcare in Africa on a Par With the Rest of the World." This is global bioethics click-bait.

Turns out the article is written by the President and CEO of GE Healthcare. GE, or General Electric, is one of the biggest multinational corporations in the world in terms of gross revenue and profitability. And the content of the article is basically about GE Healthcare's good works, or at least ambitious plans, in Africa. More specifically, GE Healthcare is spearheading an effort to increase access to medical diagnostics (mammograms, X-rays, ultrasound) and training local health providers to use them. The President/CEO does realize technology is not going to solve everything: "Sustainable Healthcare Solutions don't come in boxes. They come in partnerships. In understanding the root causes of a challenge. In wanting to do well while doing good."

Pardon my skepticism. Diagnosis is a good thing, but this particular effort may increase the number of diagnosed conditions for which the patients may have no access to appropriate treatment or care. At best, it is a piece in a massive and complex puzzle. The idea too about the insufficiency of technology and the need for partnerships etc. isn't exactly new either, and past similar initiatives haven't bumped up the health indicators in a favorable direction much. That is because the 'root causes of a challenge' in this case come from outside the healthcare domain itself, the old social determinants of health. Since tackling those is typically unprofitable, as well as politically sensitive, it is hard to see why GE would have a dog in that fight. And bringing healthcare 'on par with the rest of the world'? Which part? Hopefully not the part with the highest rate of personal bankruptcy due to high healthcare costs.

Furthermore, GE Healthcare is a 'premium provider' on AllAfrica. What this apparently means is that it has paid AllAfrica for the privilege of writing or commissioning glowing articles describing its African activities. GE even has its own website embedded in the website. If nothing else, this allows the attentive reader to contemplate how GE's activities in general impact on the health of Africans. The article on GE's expansion of its footprint in the oil and gas sector in Nigeria is a nice place to start. But in the end, readers will have to look elsewhere than AllAfrica.com if they want balanced and critical information on the increasing penetration of Africa by multinational corporations, particularly those who downplay their profit motives and promise nothing but good.

Is there an 'African bioethics'?

Well, is there? There have been a number of published attempts to isolate what is different about African ways of identifying, analyzing and resolving ethical issues related to health and medicine. Usually there is talk of African communitarianism, solidarity and Ubuntu, to be contrasted with the typically ‘Western’ emphasis on personal autonomy. But as time goes on, this whole narrative seems more and more contrived and out of step with reality. We know autonomy has limits, and does not automatically trump other considerations in cases of moral conflict.  The stress on communal life and social harmony in African morality has similarly been oversold: contemporary ‘African life’ is not predominantly lived in villages led by traditional elders where communal problems are resolved by palabre under a baobab tree. That image is becoming increasingly quaint against the influences of colonialism and globalization, increased urbanization, digital communication, and the subsequent fraying of traditional community structures.

A couple of recent articles probe into what an African bioethics might mean. In Developing World Bioethics, Gerald Ssebunnya argues that the pursuit of a distinctly African bioethics is basically a fool’s errand. According to Ssebunnya, the whole idea that an African bioethics exists – or ought to – comes from Africanist philosophy and the desire to distance African philosophical thought from that of their past colonial masters and oppressors. Unfortunately, he writes, that meant falling back on what he calls ‘ethno-philosophy’, which consists of two main activities: (a) unreflectively recycling bits of common morality and (b) polemically talking about the nature and need of African philosophy rather than actually doing it. His remedy for what he calls this ‘sterility’ is for African bioethicists and other African stakeholders to work on the foundational, conceptual underpinnings of bioethics, and thereby contribute African elements to the ongoing global discussion about what makes health-related policies and practices ethical or unethical.

The article by Sirkku Hellsten in the Cambridge Quarterly of Healthcare Ethics is about the role of philosophy in global bioethics, but also touches on the notion of regional flavors, like ‘African bioethics’. Using Henry Odera Oruka’s four types of African philosophy, she distinguishes four ways of philosophizing in bioethics worldwide: ethnophilosophy, philosophic sagacity, ideological philosophy, and professional philosophy. She makes a good attempt at describing the strengths and weaknesses of them all (and has the good grace to keep calling the first three 'philosophy'), but really, only professional philosophy contains something universal: the critical use of reason in examining and developing arguments. That is, and should be, the philosophy behind global bioethics. Hellsten seems undeterred by the fact that this universal method historically originated from the European Enlightenment, or that the method is known to be vulnerable to influence by cultural factors (or as she calls them, ‘biases’).

Where does this leave African bioethics? One option is that Africans keep producing bioethics informed by philosophical approaches Ssebunnya (and probably, in her heart of hearts, Hellsten) considers 'sterile.' Another option is that Africans are paradoxically meant to double-down on their Western philosophy, rather than avoid it, in order for African contributions to global bioethics to be born. Maybe this is where these two authors are going. Apply ‘universal method’ to African circumstances, stir. Will the resulting concoction be, in some way, African? 

The bioethics of austerity

One of the more depressing aspects of the crisis in Greece is the cartoonish way the plight of the Greek people has been portrayed. It is as if ordinary Greeks had all taken out massive and reckless loans, and when asked to pay them back, they stubbornly refused. The nerve of such people! Do they want money for nothing? Can't they pay off their debts like us, i.e. hard-working sensible people? How lazy and irresponsible of them.

Africans may view all this with a sense of dèja vu. In the years after independence, the ruling class of African countries brought their economies into debt, while rulers enriched themselves from revenue generated by the selling off of their natural resources to the developed countries in the North. In the 1980's and 1990's, the collection agencies of the international creditor community (i.e. the World Bank and the IMF) imposed 'structural adjustment programs' that involved reducing expenditures by the public sectors -- especially education and health -- opening up markets to foreign investment and establishing debt repayment schemes. This was austerity avant la lettre, whose effects in Africa were largely catastrophic and are still felt right up to this day. In this way, Africa was a laboratory for a new, 'bloodless' way of dominating and exploiting other countries, not by armed conquest, but by debt. Debt in this geopolitical context is not like the debt you incur when you voluntarily take out a loan to buy (say) a car. No ordinary African citizen voluntarily asked for despots and kleptocrats to siphon off national resources, run their country deep into the red, and then agree to repayment terms and conditions that gut their schools and hospitals. Africans are familiar with European powers doing this to them, and accusing them of laziness in the process.  Europeans doing it to one of their own: now that is new.

Just like the African case, the Greeks are getting hit ... right in the health sector. Crumbling infrastructure, doctor and nurse burnout and brain drain, use of cheap but unsafe materials, shortages of medical supplies, increasing inability of patients to pay for services: all the classic symptoms of austerity health care. The imposition of austerity will be predictably associated with avoidable morbidity and mortality -- and it is avoidable because austerity is a political construct, not a natural event. If the more powerful countries want to bail out or provide debt relief to certain countries or institutions, they can and they have. So they are at least partly responsbility for those consequences when they decide not to, both in the old African case and the new Greek one.

Penile transplants and ritual male circumcision in Africa

It should not be going to too far out on a limb to say that ritual male circumcision is not, and never has been meant to be, a medical intervention. Certainly in sub-Saharan Africa, where it has generally been understood as part of a larger rite of passage from boyhood to manhood, questions of safety, hygiene, pain relief or psychological trauma are typically not concerns central to the ritual. If they were, the use of unsterile instruments by non-surgeons on the un-anesthetized would have led to the disappearance of the practice long ago. The ritual is about risk, not safety; it is about testing an initiate's response to fear, not making the youth feel comfy. And what is more fearful that the threat of a sharp instrument being brought to bear on your private bits? One can be appalled by the practice, but you have to at least acknowledge that it is not an attempt to do the same thing as medical circumcision, except more primatively and with higher complication rates. It has unsafe practices partly because it serves a whole other purpose.

Nevertheless, it is hard to say that penile amputation or death are just the price you pay for ritual male circumcision, and those who think otherwise should just man up. Are you culturally ignorant if you care about and want to protect those who are harmed by traditional circumcision? Are you culturally insensitive if you want to change the practice to reduce harm to persons? One interesting development related to the issue has been the announcement of the first penis transplant. A nine-hour surgery by a South African surgical team late last year transplanted the penis of a dead donor to a young man who had lost his own member due to ritual circumcision complications. To barely-contained chuckles in news reports and the twitter-sphere, the patient enjoyed a rapid recovery, successfully putting his Johnson through its sexual paces only five weeks after surgery. Bad knifework corrected by better surgery, giving hope to all those harmed by ritual.

There are some puzzling and disquieting aspects to the story though. I suppose the first is that I never realized that you could donate your penis. Is this a checkbox on a form? The second is the question -- never answered in any news report that I saw -- whether the donated penis was itself circumcised. If it  wasn't, this could be a first: the first man to be circumcised twice. But most of all I wondered: how many of those who suffer from penile amputation via ritual circumcision are in a position to afford a nine-hour operation? And how will having another man's penis play itself out in their communities? Will it be considered more or less strange than not having one at all? And to what extent is this surgical achievement an adequate response to the deaths and dismemberments of ritual initiates occurring each year, rather than showcasing what powerful medical institutions are able to do?

Prevention rather than treatment is probably the only realistic way to cut down on the morbidity and mortality associated with ritual male circumcision. The problem is that it is unclear how to minimize the harm associated with the practice without significantly altering its meaning. Probably no headway will be made until the adherents themselves (and not just outsiders) regard the deaths and mutilations as matters of deep moral concern, rather than something that just comes with the ritual territory.

Ebola and the ethics of research design

A couple of recent articles stimulated my interest on the ethics of conducting ebola research, particularly with those conducted in low-resource settings and having a randomised controlled design. It interested me enough to write a letter to JAMA, where it got bounced.  I thought about submitting to Lancet, but hip replacement surgery got in my way: just too much work. So it goes. Part of what is fascinating about the topic are the underlying issues regarding whether doing anything other than the 'gold standard' of clinical trials is justified. I am diverting this piece to Global Bioethics Blog just in case a reader finds something of value in it. 

Two recent commentaries in this journal argue for and against conducting randomized controlled trials (RCTs) of new Ebola drugs during the current epidemic.[i] [ii] Those in favor argue that only RCTs can deliver the evidence required to treat future Ebola patients in ways superior to the current standard of care, which is largely palliative. Other observers hold a similar view.[iii] Those opposed to RCTs in this context argue that if patients were randomized to study arms of either (a) a new drug or (b) the baseline 70% mortality rate for Ebola, such a trial would not possess equipoise, because (arguably) the intervention arm would likely provide at least some benefit. In addition, opponents argue that local communities ravaged by Ebola – whose trust in authority, including medical authority, has been profoundly shaken -- are unlikely to accept a randomized controlled trial design.  They therefore advocate for experimental drugs to be offered to patients within non-RCT research designs, even if they have not been tested by the ‘gold standard’ methodology.   

On the face of it, this seems like a conflict between advocates of evidence-based medicine and those who understandably, but misguidedly, want to provide less-than-well-tested drugs to the sick as soon as possible. But while the former position seems rational and impartial, history reveals some unsettling patterns. When the HIV epidemic was raging in the United States decades ago, advocacy groups mobilized aggressively for expedited access to new experimental treatments, bypassing the full FDA approval process.[iv] The alternative then, for many AIDS patients, was death. Current policies surrounding ‘compassionate use’ were borne out of this experience. This raises the question: is it easier to take a hard utilitarian position on the need for RCTs when it is someone else’s epidemic?

The faith placed in scientific knowledge to resolve deep social problems is also part of an old pattern. When health crises occur in developing countries, international efforts often focus on fast-tracking biomedical interventions rather than also engaging the social, economic, and political factors contributing to emerging infections. Citizens of low-resource countries have every right to be skeptical here. Drugs to prevent mother-to-child HIV transmission were tested and developed two decades ago; only 57% of women in sub-Saharan Africa currently have access to it.[v] The same (or worse) can be said for a host of other diseases. Access to new Ebola drugs, should they be successfully developed, will likely to follow the same trajectory. Again, the argument that we should only encourage RCT trial designs for new Ebola drugs, out of scientific concern for the evidence base, may be more compelling in places other than Monrovia.

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[i]Shaw S. Randomization is essential in Ebola trials.  Lancet 2014; 384: 1667. 

[ii]Adebamowo C, Bah-Sow O, Binka F, et al. Randomised controlled trials for Ebola: practical and ethical issues. Lancet 2014; 384: 1423-1424.

[iii]Joffe S. Evaluating novel therapies during the Ebola epidemic. JAMA 2014; 312(13):1299-1300.

[iv]Dresser R. When Science Offers Salvation. 2001. Oxford: Oxford University Press.

[v]WHO/UNICEF/UNAIDS. Global Update on HIV Treatment 2013: Results, Impacts and Opportunities. http://apps.who.int/iris/bitstream/10665/85326/1/9789241505734_eng.pdf?ua=1

Susceptible to Ebola, immune to criticism

Karl Marx famously wrote that "... philosophers have only interpreted the world, in various ways. The point, however, is to change it." The quote by Marx is sometimes used to bash 'academics' in the name of world-changers, men (and women) of enterprise, the 'hands-on' types, interveners, implementers, and so on: what we need is action, not thinking! This, of course, this turns Marx into a cartoon. If he knew the shortcomings of thought without action, Marx also recognised the perils of action without thought. Marx was a German philosopher. He thought for a living. But that hasn't stopped lesser minds from treating action as if it were a good in itself, something we should not distract with reflection or critique. Just do it.

I read today an opinion piece in US Today that brought the above thoughts to mind. In it, Franklin Graham, the head of the evangelical/relief organisation Samaritan Purse, claims that there is no ethical issue involved in providing Dr. Kent Brantly (employee of Samaritan Purse) privileged access to a experimental drug for his Ebola infection. Those who think there are ethics to debate here are merely intellectual elites ('academics' , 'talking heads' ) far removed from 'primitive deathbeds' in Africa, and the ethical debate -- politically correct analysis from the cozy confines of America -- does nothing to help save people at death's door. Dr. Brantly, the piece goes on, left the comforts of America to provide medical assistance in Liberia, got infected with Ebola in the process, and what happens when he gets access to the scarce experimental treatment? People debate about whether that is ethical or not. This is outrageous, because:

this drug is being used to save a doctor who will say thank you by returning to some of the darkest, dirtiest, loneliest places on earth to bring hope and healing to others. What is the ethical dilemma in that equation?

It is hard to know where to start. I suppose the first point to consider would be the neo-colonial, 'Heart of Darkness' description of someone else's country as the 'darkest, dirtiest, and loneliest places on earth.' Apparently the dark, dirty and lonely people should simply be grateful for whatever help they manage to get, and if American academics say anything, they should be singing the praises of the organisation's humanitarian actions. Therein lies another assumption: if you save the lives of individuals, or if your organisation has the mission to save the lives of individuals, then any critical perspective on you or your organisation is inappropriate. Medical humanitarian organisations sometimes take this defensive stand, despite empirical studies that have shown that they are (predictably) a complicated source of good and bad, rife with ethical challenges, like any other sort of human institution. And as for the assumption is that only faraway American academics have the luxury to raise ethical concerns about giving privileged access to experimental treatment to an American doctor and missionary, i.e. people unfamiliar with and untouched by African realities ... think again. The ethical questions around this issue are being debated within Africa, by Africans, as well. Africans also think about issues of global inequality and injustice when they see socio-political elites being whisked off to superior health care, not just when Westerners get sick and get evacuated to the better hospitals in the brighter/cleaner/happier countries, but also when their own political leaders get sick and are flown up to fancy clinics in Paris or London. It is not politically correct analysis, it is painful reality.

The story about the Americans gaining access to the experimental Ebola treatment does reveal something about the state of the world, including its ethics. Debating the ethics is not inappropriate, nor does it hinder efforts to control Ebola. To see this though, you have to move beyond the missionary position.

Ebola ethics

Interesting to see the kinds of attention that has been given to the most recent Ebola outbreak in Africa. Part of the reason is that it is a serious epidemic, causing nearly a thousand deaths so far, and it is occurring in West Africa, rather than its usual stomping ground of the Democratic Republic of Congo and thereabouts. Another reason is that some Americans overseas have been infected, and medically evacuated back home, so the story involves not only the familiar 'death exoticism' of faraway anonymous Africans, but has a US domestic component as well.

Perhaps because it involves American citizens, bioethicists have been more active in commenting on the ethics of Ebola control than they were during outbreaks of times past. Two of the infected Americans have been treated with an experimental Ebola drug, the access to treatment being aided and abetted by the National Institutes of Health and the Centers for Disease Control no less. Bioethicists, chronic worriers that we apparently are, worry about this development. If the drug has not been FDA approved, how do we know that it is safe and effective? Even if the conditions of the American patients improve, how do we know whether the drug itself is responsible, if no rigorous clinical trial has been conducted? Why would people continue to join clinical studies if they could gain access to experimental drugs outside the FDA's vetting system?

All fine and good, as worries go. But I wonder what would happen if the Ebola outbreak happened in Louisiana rather than Liberia. Would the American public and leadership -- including its bioethicists -- be so sanguine about waiting years for the results of clinical trials before trying some promising-looking drugs out? Faced with an infectious disease with a very high mortality rate, would we revisit and loosen the rules or hold firmly to the tenets of evidence-based medicine? Is the latter what happened, say, early on during the US HIV epidemic? Or is the ethics a bit different when it is largely somebody else's deadly epidemic? For its part, the World Health Organisation seems more open to the use of not fully tested treatments, for Africans, given that the current alternative for most of those affected is (as the Director of the Wellcome Trust put it) a tepid sponge bath and the promise of a nice burial.

UPDATE: The Scientist issued a short piece on the subject of Ebola and ethics last night, and USA Today has a piece up, with reader comments.

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.  

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? 

Health care strike in Mozambique

When I was in Maputo last week, the big ethics issue in the country had nothing to do with biomedical research. There was a buzz about a possible doctor's strike. But the doctors I met said it was actually a bluff: the government would open negotiations before the strike deadline, the medical association would craft some sort of compromise, and the whole thing would blow over. On the other hand, Doctors in Mozambique did go on strike back in January for nine days, though there are conflicting reports as to the extent of the strike.

Well, today they are striking again. According to the newspapers, doctors are demanding a base salary of $3000 per month, while the government is offering between $600 and $1200. Much of the problem has to do with equity: the doctors in the public sector in Mozambique are government employees, and there is a strong sense (rooted in Mozambique's Marxist tradition) that there should not be significant inequities in pay between public sector jobs. If the government raises the base salary of doctors, but does not offer something similar to other public sector employees, they may have a more general strike on their hands. However, if they do not satisfy the demands of the doctors, the lives and welfare of citizens may be in danger: even if the Mozambique Medical Association insists that essential services will remain open, I heard much dispute about what should count as 'essential' in such circumstances. In any case, it would not take much of a strike to have a significant impact on patient health, given that the physician/patient ratio is 1 to 22000.

Ethics of implementing male circumcision in Swaziland

Dispatch from Maputo, Mozambique. As far as I know, the European Union has sent me here to discuss ethical issues in research with new ethics committee members. In the past, there was only one ethics committee in Mozambique, whose original mission was to review all health-related research. As requirements to get ethical approval (for funding, for publication, etc.) get more strict, and the number of local research studies involving human participants rises, having just a single committee is no longer workable or sustainable. So they are wisely decentralizing into a number of institutionalized ethics committees around the country. I am here to discuss the ins and outs of ethics committees, their ups and downs, their virtues and vices.

During downtime in the Hotel Cardoso, I noticed this piece about implementation of male circumcision initiatives in Swaziland. Apparently, these HIV prevention initiatives have not come close to reaching their targets, after millions of dollars have been spent, causing both soul-searching and finger-pointing. (The program spent almost 500 dollars per circumcised male in a country which has an average per capita annual income of roughly $5000). I've thought for a long time that much more bioethics attention -- to its detriment -- has been spent on research ethics than the ethics of implementing research results into practice. The latter has its own particular conundrums, such as: what do you do about a (less than) half-implemented program? Particularly when part of the reason why the implementation was partial is due to significant community reluctant/resistance towards the very idea of male circumcision for HIV prevention? Where should you go from here?

Community concerns about male circumcision and HIV prevention include: why do circumcised men still get counseling about using condoms? What happens with the foreskin? Is there any connection between these circumcision programs and witchcraft? Why must men need to refrain from sexual activity for some time afterward? Other forms of resistance or reluctance, in the Swazi case, reach up to the highest levels of policymaking. Local public health authorities may have been interested in gaining funds and collateral benefits from male circumcision initiatives, while being skeptical about the value of the intervention itself. Low community and governmental 'buy in' (as they call it) can derail any public health program. Add to this the work of the anti-circumcision groups and individuals worldwide, who can be found on the comments section of any news item on male circumcision and HIV, whipping up fears and debunking the science. For the latter, the ethics of implementing male circumcision programs is simple: just make it stop.  

The medical neglect of the African mouth

In some ways, dentistry is the black sheep of the medical family. The social status of dentist in most places does not seem to be on a par with that of a (real) medical doctor. It is not entirely clear why this is the case, but there are conjectures. Perhaps because a trip to the dentist is commonly associated with pain, despite advances in dental anesthetics. Maybe it has to do with historical associations: what later was called 'dentistry' emerged from the Medieval practices of barbers, who besides cutting hair were self-proclaimed experts in tooth extraction. Or it could be that oral conditions are just not to be taken seriously, in the sense that they are generally not life-threatening: this is what separates the dentist from the cardiologist or neurosurgeon. In any case, when dentistry is taken less seriously, it is seen as a lesser priority by funders and policy makers, not to mention the faint attention it is generally given by bioethicists.

A recent article reminded me of the sorry state of dental research, practice and policy in Africa. When health care systems are compromised by poverty and civil conflict, dentistry is regarded as a luxury and treated accordingly.  The article is focused on Swaziland: a country of 1.2 million persons served by nine private dentists, along with another 15 public dental practitioners, although the latter do not have the specialized skills to conduct root canal procedures or the fitting of dentures. What's worse is that the diet of Swaziland (like much of Africa) is becoming more 'Westernized', i.e. more processed and sugary foods are hitting the markets, leading to cavities unlikely to be filled. A rise of a neo-Medieval practice of tooth extraction is likely to accompany the change in food habits.

While oral conditions are not typically life-threatening, anyone with a toothache (or other dental conditions) can attest to their negative impact on quality of life. And quality of life, on that level, anything but a luxury. Given the track record on affordable and equitable access to primary health care on the continent, as well as the traditional subservient position of dentistry within the culture of medicine, the road to better dental health and dental practice in Africa looks to be long, hard and bumpy.



 

Africa does not need your (dirty) underwear

Friends of mine notified me about a company in Canada, Nectar Lingerie, which is promoting a campaign to send women's 'gently used' underwear to Zambia. The campaign is advertises its humanitarian motivations as follows:

In many parts of Africa, women go without bras and panties because they cannot afford them. Bras and underwear are considered luxury items. Wearing these items raises the social status of women in their communities, which reduces the instance of rape and helps stop the spread of infectious diseases. 

But this statement does not seem to be evidence-based. This is the first time that I have heard of a widespread African panty and bra shortage. And I have not seen data from the Journal of African Knickers comparing how many women are going commando in low-resource countries as compared to their more affluent counterparts. In any case, it is hard to say how wearing drawers could raise the social status of women, unless they flash them, wear them on the outside of their clothes, or otherwise make their smalls known to the community. And as for the idea of undies as means of combatting rape and infectious diseases in Africa, it is hard to know what to say. It seems analogous to sending (used?) plastic forks to Africa to combat malnutrition. But this is more insulting: with rape and gender violence being such a serious and pervasive structural problem in Africa, the idea of sending drawers -- used drawers for god-sake -- as a response is appalling. In addition, once you remove the 'humanitarian justification', you are left with a company that shamelessly and cynically proclaims itself to be 'helping Africa' in order to raise sales among the developed world ladies. Exploitation anyone?

After a few pointed emails from friends, Nectar Lingerie took down their Undies for Africa webpage. But they cannot take down everything, and you can find remnants of it, for example here and here. But this made me wonder whether there similar campaigns around. And sure enough. How would you like your drawers to have been previously aired on Shildon High Street, by a funeral company no less? The maternity underwear company in New Zealand Hot Milk has its Knickers for Africa campaign, which also trots out the idea that panties are an unbelievably effective barrier against rape, HIV and sexually transmitted diseases, based on the musings of a local priest in Zimbabwe. I am sure there are more of the same.

Bottom line: just like Haiti does not need your Superbowl t-shirt, Africa does not need your Victoria's Secret hand-me-downs.

HIV cure of the month

Over the last two decades, there has been two tracks on HIV cures: the scientific track, which has not been very successful, and the ethno-religious track, claiming a long series of successes, none of which  have been substantiated. Africa is a leading producer of faith-based and herbal remedy HIV cures. The BBC reports this week that faith healers in England -- apparently of African origin -- have been claiming to make HIV-positive persons test HIV-negative through prayer. One of the groups involved is the Synagogue Church of All Nations (SCION) in Nigeria, whose website includes YouTube videos of believers being healed of various diseases and conditions through the miraculous workings of faith healers. In England, these sorts of groups are accused of telling HIV-positive persons to stop taking their antiretroviral therapy; three deaths were attributed to these practices of Evangelical Christian groups last year.

The relationship between ethno-religious cures and Africa is an curious one. Africa is the origin of HIV,  and though it is not rational, there is some sense of shame there, that this should not be seen as an 'African product'. I remember people in the DR Congo claiming that HIV could not have come from their country: it must have been snuck in from Rwanda or Cameroon. There is also a persistent rumor in Africa that HIV came totally from the outside, from the leading powers of the world, as a diabolical plot to depopulate the African continent. In this context, the idea of an indigenous, non-scientific African cure for HIV becomes very tempting, a delicious thought. After all the high-tech, heavily funded biomedical struggles of powerful and affluent nations to find a cure, the answer comes from something local, homespun, either natural in the form of herbal concoctions, or supernatural in the form of African religiosity. If that was the case, it would be an incredible coup.

Unfortunately, that is not the way it is. In the English case, it looks much more like religious quacks taking advantage of and endangering the well-being of HIV-positive persons, as well as those with other illnesses. British health authorities are unwilling to comment on the matter for fear of alienating religious sensibilities. But they should. Religious organizations, just like secular ones, should come under the scrutiny of the law if their practices seriously threaten the health of its adherents.  

Top 10 HIV and ethics stories for 2011

I was looking on the web today hoping to find a top-10 list of bioethics stories for 2011. It is time of the year for such lists, and you would think that someone would be busy compiling bioethics stories of global significance, like whether extremely obese kids should be removed from their parents, the identity issues raised by face transplants or those pesky animal-human hybrids. Alas, I can't seem to find anything. There is always the Top 10 Evil Human Experiments, but beside the question of how these are determined (is there an Academy of Evil?), this is not specific to 2011. Of all places, IRIN/PlusNews, the humanitarian news and analysis service of the United Nation's Office for the Coordination of Humanitarian Affairs, has put out a top 10 list of the HIV/AIDS stories of 2011. And we can go with that, since the global significance of HIV/AIDS, and it only takes a certain degree of tweaking to turn it into an ethics list. It is in no order of importance:

1. HIV/AIDS turns 30. In June 1981, the CDC published a report in its Morbidity and Mortality Weekly Report (MMWR) about cases of what would later be called AIDS. Despite three decades of research and program implementation, both often hindered by politics and alternative public and private priorities, millions continue to be infected by HIV and die of HIV-related causes each year, particularly in low-resource settings like sub-Saharan Africa. How many died who could have been saved during this period, were it not for stigma associated with the condition and the stubborn preference among the world's wealthiest nations for military rather than health-related expenditures?

2. ARVs as prevention. Prior to 2011, there was already some evidence that being on antiretroviral treatment reduced the risk of a HIV-positive person transmitting the virus to others. The HPTN 052 study, a randomized controlled trial with sero-discordant (i.e. one partner HIV-positive, the other not) couples sealed the deal in 2011, indicating a 95% reduction of risk. The real ethical challenge now is implementation: should we target antiretrovirals for prevention purposes at those most likely to transmit the virus? How is this fair to those (such as children) who need such treatment but are unlike to pass it on to others?

3. AIDS funding. Research breakthroughs like the HPTN 052 study come at a painfully ironic time: just when real progress is made with HIV prevention research, we have an economic downturn that seriously threatens funding for studies and initiatives. The Global Fund for HIV/AIDS, Tuberculosis and Malaria just ditched its round of funding for 2011-2013, citing lack of sufficient contributions from supporting countries. What does this mean, ethically? Over the last decade, there has been a tremendous increase in the numbers of persons gaining access to anti-retroviral treatment. Cutting into programs could mean cessation of treatment, with serious potential impact on individuals and public health (in terms of rise of drug-resistant HIV strains).

4. Disappointing HIV prevention trials. The idea of giving antiretroviral drugs to HIV negative persons in order to prevent them from acquiring HIV has been kicked around for awhile, but 2011 has been an awful year for this line of research. Last year, the CAPRISA microbicide study looked very promising. But this year saw the crash and burn of two important studies (FEM-PREP and VOICE), tossing the whole pre-exposure prophylaxis approach to HIV prevention into serious disarray. Besides, if you want to (ethically) do a study with those exposed to HIV infection, doesn't HPTN 052 now imply that you ought to provide antiretroviral treatment to their partners? The mind boggles.

5. Gaffe prone politicians. Yes, this was on last year's list. It is still allowed, as long as you come up with fresh gaffes, and politicians are all too happy to help. Helen Zille, premier of the Western Cape (South Africa) apparently aimed for the title of most gaffe-prone this year. After stating that all HIV positive persons who knowingly infect others should be charged with attempted murder, she came up with a spectacular encore: the creation of an HIV lottery of sorts, where you get a chance of a cash prize if you get tested for HIV. For those not ready to regard these as gaffes, there is always Christine Ondoa, Uganda's new Minister of Health, who claimed in August to have known three persons cured from HIV by prayer. Top that one.

6. Anti-gay legislation. Anyone can make a gaffe. But attempting to make laws that discriminate against persons at heightened risk for HIV on the basis of sexual orientation is another matter. In sub-Saharan Africa, there is a perception that being gay is 'anti-African', as if same-sex orientation would be a Western import along with Volvos, Ipads and hot yoga. Mindless prejudice tarted up as defense of traditional values is nothing new or especially African, but the ferocity of the denial, as well as its negative public health consequences in the midst of an epidemic, might end up having a special African character. But not in a good way.

7. Threats to generic ARVs. HIV is tricky, and it takes a great deal of research investment to create drugs to control it. Those with the deepest pockets -- Big Pharma -- are most likely to develop antiretroviral drugs. While having cheaper generic versions of these drugs are in the interest of poor individuals and nations, it is not in the financial interest of the multinational corporations concerned. 2011 saw conflicts between generic ARV manufacturers in India and European Union, where the EU is widely seen as not being on the side of the angels. In 2012, mathematical modelers should examine the 'persons vs. patents' consequences of whatever policies come to pass.

8. Contraception and HIV risk. Some philosophers wonder if our urge to have children has any rational or ethical basis, but most take this conception as an unquestionable value. But in regions where HIV is highly prevalent, how to conceive without the mother and child risking HIV infection? A condom reduces risk of both HIV and conception. In 2011, a study suggested that a popular contraception drug (Depo-provera) increased risk of HIV acquisition and transmission. Back to the drawing board for researchers perhaps, but in the real world, couples continue to be torn between conception and HIV risk.

9. Medicines Patent Pool. As the IRIN/PlusNews report puts it, 'The patent pool was established in 2010 by the international health financing mechanism, UNITAID, and aims to stimulate innovation and improve access to HIV medicines through the negotiation of voluntary licenses on medicine patents that enable generic competition and facilitate the development of new formulations.' Quite a mouthful, but the point (see #7) is the impact this initiative has on patient access to HIV medicines in actual practice. Gilead should be commended for dipping its toe into this new pool in 2011. We will see if other big pharmaceutical companies follow suit.

10. New HIV targets. Yes, it is easy to get cynical about ambitious targets set by international health agencies, when you consider they rarely if ever get met. In June, the United Nations came out with the language: 'Zero new infections, zero stigma and zero AIDS-related deaths." On the face of it, a bit ridiculous: really, zero? Can we believe that any more than zero-teenage pregnancies, zero-drug abuse, or zero-drinking and driving? In reality, it is more a rallying cry or slogan than a goal. Goals have numbers on them, and the numbers are generally not 'zero'. Doubling the numbers of those on ARV treatment, halving TB-related deaths among HIV positive persons, bringing mother to child transmission of HIV down towards zero, and increasing prevention options among the vulnerable are valuable goals. This may be deja-vu for resource poor countries in Africa, and in an economic downturn the probabilities are altered. But it is better to have targets than none at all, as long as there is some commitment to pursuing them. Something like New Year's resolutions?

The unbearable fragility of HIV treatment access

It has taken a tremendous effort, over the course of many years, to give HIV-positive persons in sub-Saharan Africa access to antiretroviral treatment. On the World Health Organization's latest reckoning, over five million persons are now on treatment worldwide. However, the success is partial: another ten million persons in need of treatment currently do not receive it, and the pool of those who will need treatment in the future is expanding furiously -- over 7000 new HIV infections take place globally every day.

Even the partial success in access to treatment is very, very fragile. The global HIV treatment initiatives are generally bankrolled by the developed world's financial heavyweights who (after debilitating their own economies) are calling for austerity and belt-tightening, and programs supporting the lives of distant others are looking vulnerable.

But the challenges to maintaining and expanding HIV treatment programs apparently come from all angles. AllAfrica, that great warehouse of online African news, gives two recent examples. Kenya has been hit by a rise in food prices and a drought. Nearly two and a half million Kenyans are regarded as food-insecure, as prices have risen 15 percent; herders are losing their livestock in the dry north-east of the country, and some are fleeing to Uganda. For those who are food-insecure, HIV-positive and in need of antiretroviral treatment, the situation is grim: even for those who can access treatment, the pills are very hard to tolerate (and less effective) on an empty stomach. Some people would rather go off treatment than deal with the side-effects, though this could lead to resistant strains of HIV; others are reluctant to start treatment, which is likely to lead to poor clinical outcomes. In Tanzania, another twist: a sizable patients taking antiretroviral treatment may fail to adhere to treatment in their quest for the latest miraculous herbal cure. A former Lutheran pastor in the village of Loliondo has concocted something which has stirred a great deal of excitement, as would any substance promising to cure diabetes, tuberculosis and HIV. The ingredients are unknown, but the Tanzanian Drugs and Food Authority, the National Institute for Medical Research and the Muhimbili National Hospital endorse the herb as fit for human consumption. But there is no proof of its efficacy. No matter: people with HIV are flocking there by the thousands, some persons literally dying to get there. The Tanzanian authorities are struggling to convince people to continue taking their drugs, and not succumb to the siren song of an HIV/AIDS cure. (It is always more pleasant to imagine an indigenous cure than deal with the reality of depending on products of foreign multinational pharmaceutical companies.) With all these pressures -- economic crises, natural disasters, rising new infections, strange cultural manifestations -- is it reasonable to expect the pool of those accessing HIV treatment to continue to expand? What is the plan B if the bubble bursts?

Pneumoccal vaccine in Africa: one step forward, one step back?

It is pretty well known that many routine medical interventions in the world's more affluent countries make infrequent appearances -- or sometimes none at all -- in the world's poorer ones. The publicly-financed health care systems in some sub-Saharan Africa look to be decades behind the United States, Canada or the United Kingdom when it comes to devices, drugs and procedures. For that reason, initiatives that seek to close the gap are, in principle, to be welcomed. Oftentimes, however, these initiatives are accompanied by moral baggage.

Take for instance the launch of a new pneumoccal vaccine among children in Africa. Considering the number of childhood deaths attributable to pneumonia in this part of the world, the effort has an initial air of nobility. Many lives will be saved, many illnesses avoided. But if one looks more closely, serious ethical problems seem to emerge. There are two multinational pharmaceutical companies involved in the campaign -- GlaxoSmithKline and Pfizer/Wyeth -- who have agreed to sell 30 million doses every year for ten years at $10.30 per child vaccinated. These companies also stand to each gain $225 million in subsidies through their involvement in this scheme. Doctors Without Borders worries that this price for vaccination is very high for many countries, and that the lock on the market exercised by GSK and Pfizer/Wyeth will strongly discourage local companies from developing cheaper generic equivalents. The companies are establishing their brand under favorable circumstances to themselves; after that, all bets are off.

Some people argue that pharmaceutical companies should be given incentives to focus greater attention on developing countries, otherwise they will simply develop whatever is likely to sell to richer consumers elsewhere. But the pneumoccal vaccine example can make you think twice about the wisdom of 'incentivizing'. In the short term, many children will be vaccinated. But in the long term, unless prices are made to go down, children of wealthy elites within developed countries are most likely to benefit. The usual pattern threatens to repeat itself: big business wins, the higher classes win, and the rest struggle on.

The God Committee, Africa-style

Who knows when bioethics started? Like other annoying questions (When did philosophy start? When did romantic love start? When did rock and roll start?) there is probably no way to definitively answer it, but that does not stop people from trying. For some, bioethics started in the United States with the so-called 'Seattle God committee', the body of health care professionals and laypersons that was formed to decide who among patients with kidney failure should receive (then new, and very scarce) dialysis treatment. The situation in Seattle seemed to open a new field of inquiry: while the question 'who should get dialysis?' was partly a medical question, it went beyond that. It was not enough for doctors to invoke medical criteria alone, since many patients were medically needy -- the fundamental question was how to choose among them, if there are not enough machines for everyone. If not using medical criteria, what other criteria should be used, and how should we best come to reach such decisions? And so, the story goes, the idea was born of non-physicians assisting in resolving ethical problems within medicine.

This is an old tale. To read about it, you have to go back to a yellowed Life Magazine article from 1962. I was reminded of this piece of history when reading a recent article in BBC news about the rationing of dialysis machines in South Africa. It is striking that Tygerberg Hospital in Cape Town is wrestling with the same problems faced fifty years ago in Seattle, and from the reports, is not fairing much better. More specifically: just as the 'God committee' brought in controversial subjective criteria to decide who should gain access to dialysis, the committee in Tygerberg apparently cannot avoid doing the same. Part of the criteria are having 'good home circumstances' (i.e. running water, electricity, toilet, etc.), the motivation of the patient to adhere to the treatment plan and improve his/her health, and having a good social support network. It is fairly obvious that this criteria does not favor the poor. All other things being equal among needy dialysis patients, those who are better off socially and economically are more likely to gain access to dialysis. One could argue that these non-medical criteria have a medical justification: if a patient does not have good social circumstances, dialysis will not produce a favorable outcome for that patient. Probably. But the upshot is brutal. If you are really poor in Africa, and suffer from renal failure, you are seriously screwed.

In the United States, the federal government in 1972 made the unprecedented decision to extend Medicare provisions to enable the vast majority of patients with chronic renal failure to gain access to dialysis. Basically, faced with a very public rationing problem, they threw money at it. This is not an option in Africa. As chronic diseases become more and more prevalent in the region -- certainly more prevalent than new clinics, new technology and new medical professionals -- there are going to be a lot more stories like this.