Global bioethics blog

Delivering vaccines in Africa: some unethical obstacles

2009-11-08T15:02:00.006-05:00

The attention and money thrown at the H1N1 virus seems to grow by the day, even if the numbers of H1N1 related deaths, relative to other causes of mortality (including plain old seasonal flu), are still very modest. People actually die from H1N1, so it is not nice to make light of it, and because it is contagious, the death toll will rise, though we don't know how high or for how long. Nevertheless, there is no way of getting around the impression that the world's media is drawn to the latest viral threat to the richer developed nations, where the knight in shining armour is played by multinational pharmaceutical companies, whose cutting-edge research thankfully produces the latest vaccine, while the media makes rapid and widespread vaccination seem like the only rational response, and governments and local health agencies stand to be criticized for not getting vaccines into bodies fast enough. The significance of the H1N1 virus as a threat to humanity? Only time will tell. But that a great deal of money is being made: that is already certain.

Elsewhere in the world, other fish are frying. Forget new cutting-edge research for new diseases: in many countries, it is hard enough just to get the old vaccines administered, for the boring old diseases, the ones that people in developed nations hardly get anymore because they are routinely vaccinated against them. Take measles. Two troubling stories about measles vaccination in Africa came in this week.

First, here in South Africa, some media sources managed to revive the discredited measles-autism link, i.e. that the measles vaccine causes autism in children. A little media ethics for journalists working on public health issues could go a long way, and hopefully these incidents will not cause setbacks for measles eradication in South Africa, similar to the problems with polio vaccination in Nigeria some years back. The recent decline in measles mortality in Africa is a success story, but only conserted and sustained efforts (including communication of accurate health information) will keep those numbers going down.

Second, in the Democratic Republic of Congo, measles vaccination efforts face an unusual adversary: government troops. Medecins Sans Frontieres (Doctors without Borders) has accused the Congolese government of using their vaccination sites as bait. Due to a measles epidemic, MSF was vaccinating thousands of children in sites locations that are controlled by the Forces Democratique de Liberation du Rwanda (FDLR) . Knowing that people in the area would gravitate to the opportunity for measles vaccination, Congolese government troops apparently attacked all seven sites with deadly force, scattering populations (including children) into the bush. It remains to be seen if people in the area will trust going back to MSF sites for medical care, and in this troubled part of the world, that is about the only decent medical care around.

Let us compare epidemics

2009-11-02T16:27:00.004-05:00

There is always something a bit distasteful about comparing human tragedies, but it is also inevitable. The tsunami in 2004 was terrible, but was it as bad as the ongoing HIV/AIDS epidemic in Africa, which has taken millions of lives over the last decades? Darfur is bad, but has it really reached Rwandan genocidal proportions? We inevitably make these sorts of comparisons in order to get some sort of grip on what people ought to care about, and what nations ought to respond to with their finite resources. And we often lose our way.

The H1N1 virus has captured media attention, as well as substantial funding for task forces, response plans and research, particularly as increasingly more deaths have been linked to it. As has been observed many times, the 'media life' of a virus depends in large part on the extent to which citizens (especially ordinary citizens) of North America and Europe are affected by it, or are likely to be affected by it. When the centers of the world's power is under viral threat, vast resources may be mobilized, even if the numbers in terms of morbidity and mortality are, relatively speaking, small. Worse epidemics, elsewhere, receive much less press and support.

The point was not lost on those aware that today was World Pneumonia Day. Pneumonia is the greater killer of children worldwide. It is responsible for more deaths in children (2 million a year) than HIV/AIDS, measles and malaria combined. The tragedy is that we long ago developed effective vaccines to prevent it, and antibiotics to treat it, but it generally affects children away from the centers of the world's power, particularly in sub-Saharan Africa and South-East Asia. While many lives could be saved in delivering known effective medicines to these populations, there is not much money to be made in the endeavor, so rallying support for pneumonia initiatives tends to be an uphill battle. But it is a matter of fighting the good fight, a matter of trying to regain some sense of proportion, and a matter of not being entirely distracted by the latest virus on the 24-hour news cycle.

I pay thy poverty, and not thy will

2009-10-25T16:00:00.004-04:00

In Romeo and Juliet, there is the scene where Romeo goes to an Apothecary to obtain a poison. Juliet is presumed dead; Romeo wishes to go to the Capulet's family tomb, take the poison and join her in a deadly embrace. The Apothecary hesitates: distribution of such poisons is against local law. The two have the following exchange:

ROMEO: Art thou so bare and full of wretchedness, and fear'st to die? Famine is in thy cheeks, need and oppression starveth in thine eyes, contempt and beggary hangs upon thy back. The world is not thy friend nor the world's law. The world affords no law to make thee rich; then be not poor, but break it, and take this.

APOTHECARY: My poverty, but not my will, consents.

ROMEO: I pay thy poverty, and not thy will.

I was reminded of this exchange while reading a blog post on the Washington Post website, entitled 'In Praise of Human Organ Sales.' The author, Gary S. Becker (a Nobel prize-winning economist) argues that allowing people to buy and sell their organs would help solve the problem of shortages in organs for transplant, while countering possible objections to this idea. Neither the proposition nor the objection are particularly new; people working in bioethics have made this proposal before and objected to it before. The novelty lies in how quickly and brutally Becker states his case. His response to issues of social justice is succinct:

Another set of critics fears that the organ supply would be likely to come mainly from the poor, who would be induced to sell their organs to the rich. It is hard to see any reasons to complain if organs of poor persons were sold with their permission after they died, and the proceeds went as bequests to their parents or children. The complaints would be louder if, for example, mainly poor persons sold one of their kidneys for live kidney transplants, but why would poor donors be better off if this option were taken away from them?

It is true, the poor who sell their organs, either when they are alive or posthumously, would get their cut -- like the Apothecary. The rich would get their organs, and the middlemen, well, they would get richer. The poor would be mined -- with their agreement, of course -- for organs, without this sacrifice of body parts being likely to improve their lot very much. They would not be in a position, for instance, to buy organs for themselves if they needed them. For their part, the rich would have no (economic) motivation to put up their own organs for sale. Hard to see any reasons to complain here? Depends where you are looking. Romeo was unbalanced, and desperate, but at least he was honest: I pay thy poverty, and not thy will.

Thanks to Steve Levingston at Washington Post, who sent me the link to Becker's piece, and thereby informed me about the Post's excellent Book World blog.

HIV treatment: the good news and the bad

2009-10-20T17:12:00.003-04:00

First, the good news: more people worldwide living with HIV/AIDS are receiving treatment than ever before. Over the last 5 years, there seems to have been a 10-fold increase, and now some four million people are taking antiretroviral drugs. Traditionally, UNAIDS 'epidemic updates' on treatment access in Africa made for depressing reading, with only tiny percentages of HIV-positive persons within African countries being treated. For the vast majority of Africans, HIV/AIDS remained what it was in the beginning, a death sentence, even if had obtained the status of a chronic disease in far-off (and better-off) countries. Now there are three million Africans taking AIDS drugs. This impressive achievement has taken more than a decade of advocacy, negotiations with pharmaceutical companies, creation of cheaper generic drugs, lobbying, program development, investments in local capacity ... blood, sweat and tears, in other words.

The bad news. The numbers of persons 'on treatment' cannot be trusted altogether. The statistics are developed by governments in a vested interest in stating the highest possible estimates. To do otherwise might show incompetence in the use of (mainly external) funding. The numbers also tend to reflect the number of those who were placed on treatment, and not those who later stopped treatment for one reason on another.

But even if the numbers were more trustworthy, there are other concerns. AIDS treatment and care is lifelong. To keep these millions of persons on treatment in the future requires a vast and ongoing investment. The World Health Organization is considering revising its treatment guidelines on account of studies that indicate earlier initiation of treatment increases life-expectancy. More HIV-positive persons will fall into the category of those in need of treatment, and meeting this new demand will add to the already soaring costs. In addition, some of those currently on first-line treatment will develop drug resistance and need to switch to (more expensive) second-line drugs. And last but not at all least, millions of persons continue to be infected by HIV, meaning that the 'treatment pool' will grow larger and larger in the coming years.

The old questions keep coming back: is this magnitude of spending on HIV/AIDS treatment ethically justified? Is it justified when there are other diseases and conditions, causing greater numbers of deaths, but which do not attract nearly the same level of political and financial support? Why not devote greater attention to HIV prevention research or prevention strategies that may help reduce the rate of new infections?

This is becoming a dramatic example of 'hell being paved by good intentions.' Back a few years ago, we had the unacceptable situation of Africans routinely dying of untreated AIDS, while North Americans and Europeans accessed antiretrovirals and went on with their lives. It was a striking case of global health inequality, and no one with any sense of solidarity could fail to be moved by it. But in the process of trying to improve the situation, something else, vaguely Frankensteinian, has emerged. Billions of dollars will need to be spent to keep the (growing) millions of HIV-infected on treatment. This might not be sustainable, and all the spending might not be proportional or fair, but it would also be unwise to stop financing global AIDS treatment programs now that they have been started. Halting treatment would not only spell death for those living with HIV/AIDS, it could also mean creation of new drug-resistant strains of HIV, making prevention efforts more difficult than ever.

Ethics and the global registry of clinical trials

2009-09-30T16:45:00.004-04:00

We do not really know how many clinical trials are taking place in Africa. In fact, we don't know -- and have not known ever -- how many clinical trials are taking place around the globe. And, a fortiori, we don't have much of a grip on what kinds of research questions are being tackled in such trials, and when such trials are concluded, there is often (at best) only piecemeal and partial reporting of their outcomes. The spread of clinical trials around the world has not made information about them much more available.

Why does this information matter? Knowing about what trials are already ongoing would prevent duplication and waste, and would let patients and doctors know what is in the pipeline. It would help Ministries of Health and scientific institutions define research priorities, and would assist in focusing the efforts of regulators, including those charged with the protection of human participants in trials. Those thinking of participating in trials would also be better informed about 'what is out there'. It would also allow us to learn about negative results, which tend to be underreported or selectively reported. And it would be interesting to know how much (or how little) of the global research endeavor is devoted to diseases and conditions that disproportionally affect developing countries. However, the pharmaceutical industry for their part has traditionally been reluctant to share information about their activities, not necessarily because they have skeletons in their closets (though they might), but because they feel that greater transparency might reveal too much to their competitors, and result in the sacrifice of their competitive edge.

The World Health Organization, back in 2004, launched an initiative to create a global database of clinical trials, called the International Clinical Trials Registry Platform, ICTRP. The moral philosophy behind the initiative is that information generated by clinical trials conducted worldwide constitutes a 'public good' that must be shared to improve health. But if the carrot of 'doing good' is not enough to motivate agencies to register their trials, there is always the stick: the International Committee of Medical Journal Editors (ICMJE) has a policy that if there is an intention to publish trial results in any of its 11 member journals, the trial (including Phase 1 trials) must be registered with the ICTRP. And these are real journals like the Lancet or the New England Journal of Medicine, the kind that get you tenure or help you market your drug.

This week the global registry grew an African wing. The Pan-African Clinical Trials Registry (or PACTR) has been accepted as the first World Health Organization (WHO) endorsed trials registry in Africa. This registry will channel data into the ICTRP, and therefore we will come to know more about Africa-based clinical trial activities. It will be interesting to see what's cooking once the lid is taken off and we are allowed to peer in.

Research data from developing countries as 'the new gold'

2009-09-24T16:13:00.004-04:00

The ethical complexities involved in outsourcing of clinical trials in developing countries have been discussed over the last few years, and by the looks of things, this discussion will continue. For different reasons. First, and probably foremost, because the practice itself is lucrative: there are millions of dollars to be saved by holding your trial in Mumbai rather than Miami, and success in a clinical trial, especially when translated into a well-marketed pharmaceutical drug, can reap billions of dollars in profit. Second, no one to my knowledge has ever said that the practice was morally impermissible or that it should be prohibited. It has always been a matter of how to ethically conduct such studies in impoverished communities whose members may have little to no understanding of the nature of the research and will probably not benefit much directly from their involvement. Making research ethical in such contexts has always been a matter of adding protections and safeguards. Perhaps being ethical in a deeper sense would involve chipping away at the gaping inequalities in power and wealth between the researchers and the researched, but almost no one wants to touch that one: not researchers, not their funders, and (sadly) not governments.

The Guardian in the United Kingdom has a short piece on this issue. Frankly, the article itself adds little to the debate, but some of the comments on the article are worth looking at. Some depict outsourced trials in terms of exploitation, others as opportunity; and opportunity for local communities and trial participants, not just those trying to make a profit. For example, in poor countries, getting into a drug trial might be synonymous with gaining entry to a higher standard of medical care than one would otherwise get, and prohibiting this opportunity in the name of ethics, to some observers, sounds perverse. Communities might also gain some ancillary benefits in terms of facilities or training. And yet the possibilities for exploitation are still there, and these benefits (sometimes real, sometimes not) do not silence the concerns. So outsourced trials come across as a kind of mixed blessing, a partly dirty business, but not all bad.

A detailed and nuanced understanding of global drug research and outsourcing can be found in a new book by Adriana Petryna, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. The book makes clear that reliable data in support of new investigational drug applications to the FDA is a rare and highly lucrative commodity, like gold or diamonds. But to get the data, you need humans. And not just any humans: you need humans with this or that disease or condition, preferably who have not taken many other drugs before (drug interactions may influence the data), and many other specific inclusion criteria besides. And you want the study to run in places where you can get more for your dollar (or Euro), and where the regulatory climate is still immature. Contract research organizations (CROs) are paid by pharmaceutical companies to find the right humans in the right places, recruit them, run the study, deliver the data. Petryna's book shines a light on an obscure global industry, peopled with not so much with heros and villains, but with ordinary actors engaged in a partly dirty business across national boundaries.

The regulation of desperation

2009-09-13T04:50:00.002-04:00

We think sometimes that, when we are terribly sick, medical science must have progressed to a point where there is an effective treatment. That belief (or faith) sometimes turns to be true, and sometimes not. In the latter case, there is a terrible feeling of fear and powerlessness on the part of the patient, family members and friends. Science turns out not offer salvation. So if there is a chance that some new experimental treatment, being tested or offered somewhere, could provide some benefit, this can be a wildly attractive prospect. And the idea that access to a 'last chance therapy' could be prohibited by regulations can seem like unjustified paternalism. It is a bit like the scene in Monty Python's Life of Brian, where a man is about to be stoned to death for saying the holy name 'Jehovah'. As he is lined up to be stoned, he yells 'Jehovah! Jehovah! Jehovah!', and the priest presiding over the stoning exclaims: "You are only making it worse for yourself!" And the condemned man understandably replies: "But how can I make it worse for myself?" Those seeking last chance therapies might ask the same thing: even if the therapy is risky, even if it may not help, how can I make it worse for myself?

A couple of years ago, some of the people working at the National Institutes of Health clinical bioethics program wrote about different periods and paradigms in clinical research and research ethics. According to Emanuel et. al. (2007), there have been four periods and paradigms: researcher paternalism (1940's to early 1970's), regulatory protectionism (early 1970's to mid-1980's), participant access (mid-1980's to mid-1990's) and community partnership (mid-1990's onward). The AIDS crisis in the United States drove the paradigm of participant access, with patient rights groups increasingly demanding that people with terminal illnesses (and not just AIDS) should have the choice to join experimental trials. As Emanuel et. al. write, the desperate search for treatment tends to blur the distinction between experiment and therapy. A clinic offering a new intervention may be part of a clinical trial or it may be simply be offering 'experimental treatment'. Either might help the patient, either might push our medical knowledge further: but both could be dead-ends in any particular case.

Those trying to regulate this new paradigm have their work cut out for them. Not unrelated to the fact that much clinical research is being outsourced around the world, and the rise of medical tourism, people (who can pay for it) are seeking potential therapeutic benefits from cutting edge stem-cell research or clinical practice taking place in countries like China. This research may well not be taking place in the home country of the beneficiary, due to cost or regulatory/legal prohibitions. There is the possibility that such trials or practices may not be in the best ethical shape, for instance involving unnecessary risks and promising to desperate patients more than they can keep. The underlying ethical principle behind the patient access paradigm -- patient autonomy -- is unlikely to capture all of the ethical concerns associated with globalizing experimental therapy.

Gender, sport and race in South Africa

2009-08-31T18:21:00.004-04:00

The case of Caster Semenya is fascinating from what you might want to call a 'purely bioethics' point of view. Semenya blew away the field in the women's 800 meters at the world athletics championship in Berlin. In fact, the margin of victory was so great, and the improvements in her recent race times have been so radical, that it makes you suspect some kind of artificial enhancement. But that is not it. Along with these achievements, Semenya's outward appearance (body shape, facial hair, deep voice) have raised the possibility that Semenya is not an enhanced woman, but simply a man. No, that is not right: 'simply' is the wrong choice of words. She may be biologically too much like a man to fairly compete against other women. Which leaves us (as well as the International Association of Athletics Federations or IAAF) with the unsimple question: where do you draw the line for biologically 'man-ish' women in competitive sport?

In South Africa, the question is even more fascinating, or more depressing, depending on your perspective. Caster, after all, is South African, and the debate here, reflecting local realities, turned instanteously to questions of race. The whole sticky biological question was sidelined in favor of another question: is the questioning of Caster's gender racist? A number of prominent government officials were ready to answer in the affirmative, and ventilate their righteous indignation in front of press and cameras. The idea was that Caster's gender would not be in question if she were white; she is being unfairly discriminated against. When it was pointed out that gender tests were applied also to white athletes in the past, some took a new line of argument: that the South African media did not rally sufficiently behind Caster, too easily giving in to suspicions about her gender, and this proving that the media continues to be controlled by whites. According to this view, the Caster Semanya story exposed the South African media as racist, and if you don't want to deemed a racist yourself, it is best to regard Caster as a woman. (A woman, a whole woman, and nothing but a woman.) It is unfortunate that, at least in South Africa, strange new dilemmas about gender and sport have taken a backseat to posturing about race.

Forced circumcision case in South Africa

2009-08-13T17:02:00.009-04:00

The ancient practice of circumcision never fails to stir things up. Neonatal circumcision, whose popularity has steadily declined in Europe and is on the wane in the United States, is a reliable flashpoint for ethical debate. The debate over the costs and benefits of circumcision has been stimulated by research indicating that being circumcised significantly reduces a man's chances of getting HIV via hetrosexual intercourse. In South Africa, there has been much discussion about the state of traditional circumcision rituals, given that a significant number of young men die from circumcision-related causes each year.

An ongoing case in South Africa adds some new wrinkles to ethical and legal debates about circumcision in Africa. Bonani Yamani claims that when he was 19, he was abducted from his home, taken into the bush, circumcised against his will and forced to eat his own foreskin. His father apparently arranged or otherwise had knowledge that the abduction/circumcision was to take place, and it is his father that Yamani is suing. As it turns out, Yamani had undergone a (partial?) medical circumcision some months before. So Yamani is not against circumcision per se; he is opposed to traditional (Xhosa) circumcision, which he believes is contrary to his own Christian faith. And he is naturally opposed to having had it forced upon him.

The case brings out conflicts in a number of directions. There is the conflict between the father and son. The conflict between different views of circumcision: medical, traditional and (adopted) religion. But there is also a conflict between traditional leaders (in particular, the Congress of Traditional Leaders of South Africa or Contralesa) and the South African constitution: according to traditional norms, a male Xhosa who refuses to be circumcised is to be ostracised from his community. Traditional circumcision is not a matter of informed consent. It is just simply done, as part of being a Xhosa man, and refusal is not accepted. On this view, non-traditional circumcision and community membership are mutually exclusive. Yamani's legal defense will be arguing that not being able to live as a non-traditionally circumcised Xhosa should be regarded as discrimination under the South African constitution. Members of Contralesa have publicly stated that the constitution really has no grip on this area of South African life. This should be one to watch.

Ethics, research and Medecins sans Frontieres

2009-07-31T18:23:00.008-04:00

Medecins sans Frontieres (MSF) is a humanitarian organization whose Nobel Prize winning work barely needs an introduction. They are well-known for their efforts in providing health care (among other services) to those in severe social crises and emergencies worldwide. What is less known is that MSF is increasingly conducting its own research among vulnerable communities where it does its humanitarian work. This week, PLoS Medicine published an editorial and an article about the ethical challenges faced by research conducted by humanitarian organizations and the establishment of a research ethics committee within MSF.

It makes for fascinating reading. The ethical challenges abound: what does community engagement -- a recent 'must' for ethical research -- come to when the 'community' is being unraveled by war or a natural disaster? How can consent of participants be voluntary if MSF is doing clinical research and acting as the sole provider of medical care in a certain locale? How can consent be informed when there is a blurring of lines between MSF care and MSF research? How can MSF adhere to the ethical requirement of providing research benefits to local communities, when its field sites are subject to being moved elsewhere, due to severe political unrest or larger organizational priorities? The article is invaluable in carving out a relatively new area of study, i.e. 'humanitarian crisis research ethics.'

At the same time, though, some sentences in the article left me with the impression that the marriage between MSF and its ethics committee has been unhappy at times. The paper states that the ethical review board is "not accountable for any research which is carried out against its advice," suggesting that there were cases of non-approved research. It also states that " ... not all research is submitted to the IRB for review", giving the impression that MSF researchers or other MSF staff (rather than the ethics board) have been empowered with the decision of what constitutes reviewable research. At other points, the authors (themselves members of MSF's ethics review board) indicate that their recommendations have only partly been taken into consideration in MSF's research policies or procedures. A bit strange, when you think about it: wouldn't you expect a humanitarian organization, having decided to do research on vulnerable populations, to be the most aggressively concerned about the protection of research participants?

Postscriptum: since I am still in the Democratic Republic of Congo, my eye alighted on the video posted on MSF's homepage. It is a depressing piece, but gives an impression of the situation in the east of this country, and the activities of MSF there.

Rwandan mandatory sterilization kerfuffel

2009-07-11T15:53:00.003-04:00

The impact of the internet on the processes of determining health policy, anywhere in the world, is worth studying in its own right. Case in point: last week, Human Rights Watch (HRW) came out with a press report condemning a draft human reproductive rights law proposed to the Rwandan parlement. The draft, HRW alleged, contained a provision stating that individuals with intellectual disabilities were not to be allowed to reproduce. The Rwandan draft bill contained a whole lot of controversial material besides, especially pertaining to HIV/AIDS: compulsory premaritial HIV testing; requirement of a married individual to be tested for HIV if their spouse requests it; permission of doctors to test children or incapacitated persons for HIV without consent and then disclose the result to parents, guardians or other care providers. But it was the forced sterilization that really hit the internet, here and here and here.

Rwandan government officials scrambled to do what politicians (first) do when faced with a public relations nightmare: deny everything. Damascene Ntawukuriryayo, deputy speaker of the Rwandan parliament, denied the claims of HRW, said that there was never a proposal for forced sterilization, and that plans for HIV testing before couples get married were always to be strictly voluntary, not compulsory. Apparently thinking that a good offense is the best defence, Mr Ntawukuriryayo stated that HRW should check its facts before releasing reports into the wilds of the internet.

It does not take much effort to find views that contradict Mr. Ntawukuriryayo's statements. Back on June 23rd, before the HRW report hit the web, Focus Media in Kigali published a fairly detailed article by Sam Ruburika on the shortcomings of the draft legislation, including quotations of the original text. The proposed legislation on forced sterilization appears as Article 22: "The Government shall have the obligation to suspend fertility for mentally handicapped people as long as the handicap is still persistent and upon decision by a medical team comprising at least three medical doctors. An order of the Minister in charge of health shall specify the list and implementation modalities for diseases accounted for by this article." According to Ruburika, the Chamber of Deputies approved of the draft legislation, including its articles on sterilization and compulsory HIV testing, and it was only when it reached the level of the Senate that red flags started flying.

How are we to understand this? It goes without say that pregnancy and sexual relationships involving mentally handicapped persons is a very difficult and important issue. Why the hamfisted approach? One possibility is that there are members of the Rwandan government whose views on reproductive policy, while they might express certain draconian community sentiments, are at odds with the Rwandan constitution. Fortunately there are checks and balances enough to stop these sorts of unreconstructed proposals from becoming law, but it is striking that the draft survived in that form as long as it did. It survived long enough to be detected by the internet radar -- spelling its immediate demise.

This blog has moved to Cape Town

2009-07-05T15:02:00.006-04:00

From the beginning, this blog has explored emerging bioethics, research ethics and public health ethics issues in developing world contexts. But much of it has been, unapologically, about sub-Saharan Africa. Unapologically, because these fields have been -- and continue to be -- disproportionately orientated towards what goes on in more affluent, industrialized nations of the north.

Within this sub-Saharan focus, South Africa has had a prominent place in this blog. There are probably many sources for this. South Africa is a comparatively better-off country than (some of) its sub-Saharan counterparts, and therefore there is greater exposure of bioethical issues in the press and on the web. HIV/AIDS always brings with it dilemmas for researchers, clinicians and public health policymakers, and South Africa has a devastating HIV?AIDS epidemic, coupled with standard-fare tuberculosis, multidrug-resistant tuberculosis, and as if that was not enough, extremely drug resistant tuberculosis. The country has also had a spectacularly strange Minister of Health, some of whose pronouncements and policies about HIV/AIDS could have been written by Monty Python, but of course the unfunny part was that she really meant it. And an ex-President who denied HIV causes AIDS, and a bevy of medical charlatans running about. Plus conflicts between modern medicine and traditional healers, rising up (for example) in cases where young men die by the dozen in blotched ritual circumcisions. The country also has -- a legacy from the Apartheid era, no doubt -- a strong research infrastructure capable of conducting clinical trials and therefore dredging up all the research ethics issues of doing such trials with vulnerable populations. In short, a little bit of everything.

I accepted a sort of one-year visiting professor position in Cape Town awhile ago, and arrived here last week. It is not the first time I've been in the Cape: I completed my philosophy Ph.D. while living in nearby Stellenbosch some years ago, and left the country in 2001. Some things have changed, much has stayed the same. It remains to be seen whether this blog changes, now that it is being written out of Africa.

An epidemic of health care worker strikes

2009-06-27T15:45:00.002-04:00

This seems to be a summer of strikes among health care workers, raising again the ethical issues surrounding hospital strikes, particularly in resource-poor countries. On the one hand, state-paid doctors often work in abysmal conditions for relatively meagre wages, and when a strike breaks out, it is often a matter of doctors and nurses finally reaching the end of their tether. On the other hand, patients suffer when health care workers strike. They must wait longer or seek alternative care -- if such care is available and affordable. In many poor countries, the alternatives to health care in state hospitals are few. Traditional healing is one. No care at all is another. The impact of such strikes on patients are rarely the object of scientific study, but surely long and lingering strikes, where only the bare minimum health services remain in place, must be a source of avoidable morbidity and mortality. In the middle of all this you have the Ministries of Health: sometimes acting as mediators, and sometimes (because they are arms of government) the origin of the dispute and an obstacle to its resolution.

The provinces of Kwazulu-Natal and the Eastern Cape in South Africa are in the midst of a prolonged strike. State health care workers in Zambia are facing dismissal by the government if they do not show up to work by next Monday. In Adamawa state in Nigeria, health workers have started an indefinite strike and patients seem to be leaving the abandoned wards of clinics and hospitals in droves. And in the Democratic Republic of Congo, a health care workers strike has been going on for ages, though generally unreported in the press. Our sister blog, The Francophone African Bioethics Blog had a piece about this (in French) back in May, and the strike is still unresolved.

Each strike has to be judged, from an ethical point of view, on a detailed and (ideally) balanced account of the relevant facts. But some basic principles should be followed. Urgent medical services should always continue to be provided during a strike, and those providing them should not be regarded as 'scabs' or strike-breakers. Health care strikes should be regarded as qualitatively different than strikes in other labor sectors, due to the special value of health. For that reason, a as-swift-as-possible resolution of the strike should be the top priority of the health ministries involved, because of the impact that every day of the strike has on the ethical core of the issue: patient health.

Mandatory male circumcision in the Zambian police force

2009-06-24T18:32:00.006-04:00

In the last couple of years, there have been a number of high-profile studies exploring the relationship between male circumcision and HIV acquisition. Three randomized clinical trials in Africa confirmed an association suggested by less rigorously designed studies, i.e. that men who are circumcised are significantly less likely to acquire HIV from infected women during vaginal intercourse. But what to do about these findings in terms of public health policy? The professional views and lay public opinions are highly diverse and sometimes highly emotive. Some in public health circles consider male circumcision as effective as a vaccine and the promotion of male circumcision in regions of high HIV prevalence as an ethical imperative. Others, who have ethical objections to (especially neo-natal) male circumcision in general, criticize the methodology of the clinical trials, question their conclusions, and view the promotion of male circumcision as deeply misguided and harmful.

Whatever side one takes on this issue, the approach of the Zambian police force is bound to raise eyebrows. According to the Lusaka Times, the national police force is planning to make male circumcision a requirement for all new recruits. The police force has apparently been losing male police officers to HIV/AIDS. Male circumcision is being strongly promoted in other professional contexts in sub-Saharan Africa, such as Rwanda, which has included it as part of an HIV prevention strategy within its army.

Of course, the Zambian approach is not 'mandatory male circumcision' in the strict sense: it is only mandatory among those who have chosen to join the police force. At the same time, the idea of mandatory irreversible preventative genital surgery on healthy males bound to be controversial. Making the practice obligatory, rather than a matter of choice, raises the ethical stakes: you need a very strong justification to move from voluntary to mandatory. Is the HIV incidence among policemen in Zambia very high? If so, what explains that incidence? Is male circumcision likely to counteract whatever forces are driving the high incidence? To pull off a utilitarian justification of the policy, you need to clearly show that the overall benefits of the policy will outweigh the overall costs. And even if you do, not everyone will be impressed: not everyone is a utilitarian.

For a flavor of the online debate this sort of story inspires, have a look over at the Universal Circumcision blog.

Hat tip: Daniel Westreich.

Are countries that ratify human rights treatises more healthy than others?

2009-06-09T15:30:00.006-04:00

One might think that a country which has ratified human rights treaties, and thus has made them to some extent law, will have better health outcomes than countries where this is not the case, all things being equal or at least controlled for. A study just published in The Lancet indicates otherwise. The researchers looked at some key and often-measured health and social indicators, and sought correlations between number of treatises ratified and changes in health/social indicators before and after ratification of health-related human rights treatises, as well as making comparisons between health/social indicators in a total of 170 countries that did or did not ratify certain treatises.

The results are sobering, or perhaps predictable, depending on one's pre-existing opinions about the power of human rights approaches to health. Ratification of human rights treatises does not seem to have any significant effect on maternal mortality, infant/child mortality and life expectancy. The researchers try to put a brave face on the data, by adding that ratification of human rights treatises can have some indirect (but hard to pin down) effect on health by strengthening legal arguments aiming to ensure access to health care. But in the end, money trumps law: there is much greater evidence of an association between economic conditions and health than there is between the ratification of human rights and health.

One might object by saying that ratification is the mere promise of action, just the signing of a paper, and we should only expect an effect in terms of health outcomes in countries that rigorously monitor, enforce and make its human rights commitments real. In other words, in finding no significant association, what the researchers have actually done is study the global absence of political will in regard to human rights relevant to health.

Bioethics and democracy in developing countries

2009-05-26T23:05:00.005-04:00

The fields of bioethics in many developing countries -- despite some important 'capacity-building' initiatives -- have a very limited impact. There are a few people trained in bioethics here and there, some (underfunded) centers and attenuated networks, a few scattered publications. But why should that be the case? Bioethics is decades old by now, and research and medical practice among vulnerable populations in such settings raise a great many ethical challenges. So you would think there would be more activity, more interest.

In BMC Medical Ethics (free online access here), Ghaiath Hussein takes a shot at an answer. And his answer is: politics. The flourishing of bioethics, according to Hussein, depends on a number of political factors that are not present, or only faintly present, in developing countries. The first is an 'atmosphere of freedom' where people can engage in moral reasoning without fear of censorship of or punishment for their beliefs. That atmosphere of freedom in turn depends on a socio-legal framework in which the rights, duties and responsibilities of individual citizens -- both in regard to health and other important values -- are spelled out, understood by the populace, and protected by legislative and judiciary systems. Of course, the development of bioethics is aided to some extent by economic factors, in particular the progress in health systems development and creation of medical technologies. But these would not give rise to bioethics debates they did not engage with public expectations of receiving decent medical care, and citizens having some say in health policy decisions.

It is easier to see what Hussein is saying by reflecting on the place of bioethics within totalitarian or politically oppressive regimes. Where there is little press freedom, there will be less (and less diverse) public debate about controversial issues in medical research and practice. Where those working in bioethics are regarded as 'human rights activists' and subject to special state scrutiny, it will be difficult to motivate people to pursue these interests. Where people think of health care as a 'gift', and death as a common (and mostly unavoidable) event, the provision of sub-standard medical services will not be regarded as a failure of government and a moral outrage. Where Ministries of Health have historically acted (or currently act) as an arm of an oppressive state, and are as corrupt as any other branch of government, there will be little public trust in ethical codes, regulations, licencing boards, or ethics committees that are attached to these ministries or have received their seal of approval. All of these factors, according to Hussein, have diminished the impact of bioethics in many developing countries, and have reduced it to a mere academic pursuit, tolerated by the powers that be because it is poses no threat to them.

Hussein suggests that bioethics, in some places, is a deeply subversive activity. If real bioethical activity took place in some developing countries (he includes his own Sudan), there would be an ugly and dangerous clash with the established political order. So he suggests a softer approach: depict bioethics as a mere aid to decision-making (rather than embodying important rights and values); couch bioethics in religious or religious-friendly terms; adapt bioethics to local contexts rather than depict it as a fancy 'Western' import. Once it is conceptualized this way, it becomes clearer how long and difficult the road will be before bioethics becomes a social force in developing countries.

Motherhood as danger

2009-05-18T23:50:00.002-04:00

Nicholas Kristoff, columnist for the New York Times, has an interesting piece (and accompanying video) on maternal mortality in Africa. Women in many places in Africa, die during childbirth at a depressingly high rate: 1 in 10 births in some areas. What Kristoff piece does well is give a succinct impression of the different, and often avoidable, causes of maternal mortality during childbirth: poverty and lack of education; gender inequality and the associated low priority for women's health issues; brain drain of medical personnel to richer countries; overworked health staff and abusive attitudes towards (especially female) patients; sub-standard medical facilities; transport barriers to reaching health care centers, particularly for pre-natal services. The avoidability of death in such cases -- sometimes a mother's life could be saved with a few dollars -- makes this an ethical issue, and not just a medical one.

The unbearable lightness of international research law

2009-05-14T19:08:00.007-04:00

I am on a number of bioethics and research ethics listservs, mailing lists and have set up a couple of google alerts. This means that I tend to get news of everything bioethical that has been freshly posted on the web at least three times. When something comes out in a major journal, then this number increases. So when George Annas' piece on the globalization of clinical trials and informed consent appeared in the New England Journal of Medicine this week, I had my hands full: even friends had sent copies or links.

The title of Annas' piece was inviting, but after reading it (twice) I felt a bit deflated. Annas starts by remarking that the situation of a decade ago, well-publicized concerns were raised about the ethics of medical research in developing countries, and these concerns have not gone away. However, he goes on to write the controversial case of pharmaceutical giant Pfizer in Nigeria has dredged up some legal opinions that might, in the future, have enough bite to provide protections for participants in international research.

To be more specific, Pfizer is accused of conducting medical research in 1996 in Nigeria involving children, where informed consent was not properly (or at all) obtained from the parents, and according to families involved, some of the children were rendered blind, deaf, paralyzed, brain-damaged or dead. In January 2009, the US Court of Appeals for the Second Circuit reversed a prior trial decision that dismissed a lawsuit against Pfizer. What matters, according to Annas, is the basis of the Second Circuit's reversal: the court's arguments implied that getting informed consent from research participants (or proxy decision-makers) constitutes a norm of customary international law, and on this point the court relied on the Nuremberg Code, the International Covenant on Civil and Political Rights, the Declaration of Helsinki and CIOMS. Moral of the story: if you conduct medical experiments without consent (anywhere and including in developing countries), then you stand a chance of being sued in courts around the world for violating an international human rights norm.

Maybe. The Pfizer court case has not been tried, so it is not clear yet whether the Second Circuit will actually decide the case in terms of international human rights law -- so far, they have only created the possibility for making such a judgment. And this comes at a time when international (human rights) laws are not exactly striking fear in the hearts of the ruthless. There is the torture question. There is the illegal invasion question. Since World War II, many international codes have been floating around, some have been made law in some countries and used in some international tribunals, but the question is open whether these developments have made a real dent in the abuse of the weak by the powerful. Someone should research the track record. Because if unconsented medical research can only be deterred by means of a (new) international human rights norm that might (more than a decade later) be applied, and that is supposed to provide substantial protections for research participants in developing countries, then the world is in far worse shape than I thought.

Drugs for neglected diseases: an immodest proposal

2009-05-08T17:03:00.019-04:00

People working in bioethics have sometimes been criticized (often by social scientists) for not being radical or critical enough. Instead of speaking truth to power, we have been regarded as purveyors of watered-down or sanitized versions of the truth, hoping that by being 'pragmatic' or 'realistic', the powers that be will actually listen to the arguments and take appropriate actions. The powers in question can be powerful research institutions, international health agencies, pharmaceutical companies, medical insurance companies or Ministries of Health. The problem: the more palatable bioethics arguments are to these powers, the more likely they are to listen, but any changes based on those arguments will therefore be small, incremental, piecemeal. On the other hand, the more adversarial the arguments, the less likely they are to listen at all. And, of course, bioethics institutions are very often closely aligned with some of these very same powers: that is where bioethics acquires much of the authority it has, not to mention much of its funding.

So in this intellectual climate, it is refreshing to read an article laying out a policy that attempts to seriously rock the boat. In the current Journal of Medical Ethics, an article entitled 'Ethical issues in funding research and development of drugs for neglected tropical diseases' (free access) has an argument which basically runs as follows. Research and development on neglected diseases, particularly those affecting developing countries, has been very limited in the last decades, despite these diseases being responsible for vast numbers in mortality and morbidity. Between 1975 and 1999, only 16 new drugs for these diseases were produced out of the 1393 chemical entities developed during that period. One explanation for this situation is the current drug patenting system. Pharmaceutical companies are primarily driven by profit motives, and the patent system gives companies years of market exclusivity for their products. Market exclusivity allows companies to charge whatever prices the market can bear. The most profitable drugs are those which don't demand large research investments, provide some small health improvement for a large population, and respond to health conditions in industrialized countries where many people can and are willing to pay the price for the drug. For these reasons, drugs for neglected diseases affecting the world's poor is simply not interesting from a profit-seeking pharmaceutical company perspective.

The alternative? Scrapping the patent system enjoyed by pharmaceutical companies altogether. Reward the development of new pharmaceuticals from public funds based on the actual impact that they will have in terms of global morbidity and mortality. This would recast the focus from profit margins of private companies (and economic interests of more affluent nations) to global health, a seismic shift particularly important for resource-poor settings with the greatest need for improvement in health and well-being.

Will pharmaceutical companies and national governments buy into this? Not likely. The historical trend is toward short-term self-interest, not long-term public goods. There are very deeply entrenched vested interests who would be strongly opposed to this idea. The public funds probably would not be anywhere equivalent to the kinds of money pharmaceutical companies are making right now. But at the very least, the immodest proposal throws a spotlight on the ethically dismal regime of global drug research and production that we current have.

H1N1 flu vaccine and the developing world

2009-05-05T23:42:00.004-04:00

Up to a few months ago, the media was almost singularly focused on the election of President Obama. Seemingly from his first day in office, the attention switched to the feeble state of the US and global economy and what the new US president was going to do about it. Now the media has had to turn to something else: the 2009 H1N1 flu. Besides dubious Hollywood films, disease outbreaks have always made for good copy, particularly if the disease is potentially fatal and easily transmissible. Virtually every aspect of the flu has been reported and discussed in gruesome detail, from the effects of the epidemic on pork production to the (overly?) strict public health measures taken by the Mexican government.

There is one issue that has garnered significantly less attention, however. If the H1N1 virus comes in a more virulent form in a second wave during the fall or winter, there will be calls to produce a vaccine against the virus. Vaccines are generally made in a handful of European or American countries. Mostly vaccines are developed in these countries by pharmaceutical companies who patent their products -- and seek a healthy return on investments -- when they go from research to marketing and sales. The question then becomes whether those in the developing world will be able to access any new H1N1 vaccine, or will we see the usual disparity of epidemic impact as already we do with HIV/AIDS and tuberculosis: the poor will be hit the hardest.

As a pair of recent articles in SciDev point out, there is no shortage of expressions of goodwill by pharmaceutical companies who say they will give out H1N1 vaccines if it comes to that. Whether that will happen in reality is yet to be seen. For when an epidemic hits, there is immediate demand for vast quantities of vaccine, and when pharmaceutical companies are on the supply side, they are sitting in a very powerful negotiating position.

UPDATE or related link: the Third World Network has put out a press release on this subject, and the link is available here.

Same but different: inequities in international collaborative research

2009-04-16T21:35:00.008-04:00

When it comes to international health research and inequality, the ethical focus is usually on the relationship between the (generally well-off) researchers and the (generally poor) participants. And rightly so. But there is another relationship which has received far less attention, even though the associated ethical problems have the same basic roots. There are, namely, vast differences in socio-economic status, political power and (oftentimes) skills among researchers from industrialized nations and researchers from in resource-poor ones. The big funders of health research -- and those that set the research agenda -- are located in Atlanta, Washington, Geneva or London, and researchers from developed nations are generally in far better positions to negotate and gain research support from them. They are also likely to have received education at well-equiped, prestigious universities, to have gained mentorship in regard to publishing in the better peer-reviewed journals, and hence to have much more impressive-looking CVs. No wonder researchers in developing countries sometimes feel they are bit players in someone else's game.

This degree of inequality can lead to tensions between researchers from abroad and local researchers in developing countries. The two live in strikingly different contexts, but they have to work closely together. To bring out the contrasts and the tensions these contrasts can raise, I have sometimes asked international researchers whether they share the global budget of their research projects with local scientists. Some do, some don't. Some don't like to disclose that they are making 400% more money than their partners. Some are embarrassed by how much of the budget goes to overhead for an institution which is already quite well off.

SciDev reports that last month a conference was held in Germany focusing on North-South research partnerships and equity. A framework was proposed whose goal is to help ensure that developing country scientists have an equal role to those of developed countries in any collaborative research partnership. Capacity-building of individuals and institutions involved in health research in developing countries plays a prominent role within the framework. But then again, similar talk was aired at least a decade ago, and it is not clear how much progress has been made in the meantime. As long as the broader inequalities between countries in the 'North' and 'South' remain in place, and there is little serious commitment to combat them, the most well-meaning initiative to create equitable research partnerships faces very considerable challenges.

Economic downturn and global health

2009-04-10T22:51:00.004-04:00

Economic crises and economic recovery plans are dominating the news. There is news about macroeconomic indicators (such as unemployment rates) as well as how the economic downturn/recession is affecting the lives of ordinary people. Or at least, the macro- and micro effects of the crisis in America, Europe and better-off nations in Asia. With rare exceptions, there is little talk or concern about how the breakdown of the world's dominant economies is playing out in the world's poorer countries, despite estimates that the numbers of persons living on less than $2 per day will soon swell by the tens of millions.

Last week, the New York Times published an editorial about the situation that many developing countries find themselves. Currency rates are falling as is demand for whatever products those countries export in the global market. Unlike the United States and Europe, these countries don't have a few trillion dollars on hand to stimulate their own economies; they are struggling to pay back the loans taken out in years past to ... stimulate their economies. The NYT editorial claims that affluent nations should give more money to the International Monetary Fund, who in turn can extend more lines of credit to developing countries. The assumption seems to be: we need to maintain the longstanding debt and dependency relationship between developed and developing countries, i.e. prop it up with more cash injections. The editorial is silent about the very spotted history of IMF loan practices and developing countries, and about who is responsible for the culture of toxic financial products that created the global financial crisis in the first place. It has a real 'rearranging deskchairs on the Titanic' feel to it.

Another publication, quite another angle: the British Medical Journal has published a thoughtful piece on the potential effects of the financial crisis on health in developing countries, and how the crisis could be an opportunity to positively change the global financial landscape. Although there is no firm data yet, the consequences of the financial crisis on health in developing countries look very dire: if you take the 'social determinants of health' model, and reasonably assume that the economy (in terms of income) partly determines health, then people in already resource-poor countries are going to get sicker, and more are going to die of preventable and treatable conditions than before. The way out, according to the authors, is not to refill the coffers of the IMF. It would be better to first ditch the idea that the more unregulated a market is, the better off the economy will be, and the better off the health of nations will be. The de-regulation of markets seems to have faciliated the growing inequalities between the health and wealth of nations over the last decades. Moreover, at crucial points where the global market was regulated -- through trade laws and regulations -- the conditions of trade were largely set by and to the advantage of more affluent nations. We therefore need to draw radical lessons from our current predicament, by reflecting on just how we got here. As the authors write, "The financial crisis gives us the opportunity to bring social justice and environmental concerns to bear on the kind of new global economic order that must be put in place." Amazing that health professionals in the BMJ are now giving voice to these views, once the mainstay of activists at global economic forums.

Exciting new bioethics research topic: the Pope

2009-03-17T15:07:00.004-04:00

Former South African president Thabo Mbeki and his fellow ideological travellers in the South African Ministry of Health encountered much domestic and international criticism for their positions on HIV/AIDS. Mbeki once claimed that he 'knew no one who died of AIDS' (it was poverty that did them in) and was cosy for awhile with a fringe group of researchers who deny that HIV exists, or if it exists, that it causes AIDS. The former president was soon clever enough to realize that these positions were very unpopular in a country with a raging HIV/AIDS epidemic, and so left it to various health authorities in the country to express similar beliefs. The former Minister of Health, Manto Tshabalala-Msimang, famously suggested that HIV virus could be treated with lemons and garlic, and that anti-retrovirals were poison, and only benefitted the pharmaceutical companies that produced them. But these were only the most flamboyant characters in the tale. The less-known story is how this absence of leadership, or just plain obstructionism, immobilized the South African health system in regard to HIV prevention and treatment for years, or what the true cost of that paralysis really was in terms of human morbidity and mortality.

Recently, however, two studies have put numbers where there was only speculation and accusation. A mathematical modelling study at Harvard University estimates that Mbeki and company's stance was responsible for the deaths of 330,000 people. A paper by Nicoli Nattrass at the University of Cape Town comes to roughly the same figures: 343,000 lives would have been saved over 9 years if the South African government was not engaged in 'genocide by sloth.'

Which brings us to ... the Pope. The Pope is visiting Africa this week, where he has declared that the use of condoms is not the answer in the fight against HIV/AIDS, and the answer is abstinence. Of course, Pope Benedict is not the first Pope to talk to Africans about how to have (or not have) sex, or the first to say that the distribution of condoms 'can even increase the problem.' As usual, these statements will infuriate many in the HIV prevention community who regard abstinence as a largely failed approach and regular condom use as a crucially important element in the struggle against HIV/AIDS.

But instead of getting angry, researchers should do with the Pope what was done with Mbeki: devise rigorous studies to quantify the number of deaths and new HIV infections that have resulted from the Vatican's position. How many new HIV infections and AIDS-related deaths might have been averted due to the Papal condemnation of condom use, particularly in Christianized African communities? And how does the resultant carnage of preventable deaths square with Christian values? It is not enough to complain: we must study the Pope and his effects, just as we would any other global health hazard.

Bioethics and the stimulus package

2009-03-10T15:55:00.006-04:00

Last week, the National Institutes of Health (NIH) announced to great fanfare its new Challenge Grants program. The grant program is funded, to the tune of 200 million dollars , by the Obama administration's American Recovery and Reinvestment Act -- part of the 'stimulus package' we have been hearing so much about. This new grants mechanism will support studies on what are called 'challenge topics', i.e. specific high impact biomedical, social and public health research areas.

Shockingly, bioethics is considered one of those areas. Applications are requested for proposals about informed consent and data access policies; ethical issues of emerging technologies; ethical issues in health disparities and access to participation in research; ethics of sharing of electronic health information; ethics of translating genetic information into clinical practice; the ethical issues involved in the blurring of research and treatment; and research on recontact issues in genotype and genome-wide association studies. Those of us working in international bioethics and research ethics were especially excited by the sentence " ... studies are needed to assess the impact and ethical considerations of conducting biomedical and clinical research internationally in resource-limited countries." This is certainly a challenge topic, and no doubt relevant, given the increasing amount of US-funded or facilitated research taking place around the world, especially in the world's poorer countries.

And then came the fine print. A couple of days ago, the NIH added a notice to the request for applications. It reads:

Funding for this program is provided under the American Recovery and Reinvestment Act of 2009 (Recovery Act). The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health. Consistent with these goals, domestic (United States) institutions/organizations (i.e., those located in the 50 states, territories and possessions of the United States, Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia) who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 (aggregate total for all subcontracts and subawards), whichever is less.

This does not mean that you cannot propose an international research ethics project involving foreign collaborators and institutions. It just means that you have to find collaborators and institutions willing to swallow the fact that, even if the topic is about health disparities and research in low-income settings, 90% of the grant money must stay in the United States. Dealing with that painful irony may be a challenge in itself.

How friendly can Big Pharma be to developing countries in a down economy?

2009-03-09T22:24:00.005-04:00

Pharmaceutical companies are easy targets of ethical criticism, and it is easy to see why. They invest vast amounts of capital to develop drugs that can be crucial for health, and seek a profitable return on their investment through consumption of the drugs by patients. Profitable returns are only likely when significant numbers of consumers suffer from the condition the drug aims to treat, and when those consumers have sufficient buying power. From a profit-seeking pharmaceutical perspective, there is little incentive to develop drugs for conditions that are prevalent in countries where few people have the wherewithal to purchase the drugs. There may be an urgent health need for such medicines, but if there is no market for them, no return on investment, then it is unlikely that pharmaceutical companies will develop such drugs or faciliate access to them. Unless, of course, developing such drugs and increasing access to them is part of a public relations ploy, meant to enhance the company's brand.

The head of GlaxoSmithKlein (GSK), Andrew Witty, apparently caused a stir at Harvard Medical School last month by promising that his company would make essential medicines accessible to developing countries and commit more resources to research on neglected diseases. More precisely, GSK will take 20% of its profits from sales in developing countries and reinvest back in local health care infrastructure, and patented medicines produced by GSK will be sold at 25% of their market value in the 50 poorest countries of the world. In addition, there was talk of a 'patent pool' for neglected diseases, i.e. an agreement between various patent-holders to share (for some fee) those patents with each other and with third parties.

These promises may make GSK look saintly, but the impression largely fades on reflection. 20% of GSK's profits in developing countries does not amount to much; an editorial in the Lancet calculates it as less than 0.1% of GSK's total profits, and the folks at Policy Innovations see this as boiling down to about $50,000 per country, hardly a generous investment in local health infrastructure. Selling patented medicines at a quarter of the usual (bloated) price may not be of much help either to those who live on a few dollars per day. And while giving access to patents sounds nice, the road from possession of patent information to research to marketing is a long and winding road paved by a great deal of money. Who has that kind of money? The big pharmaceutical companies, like GSK. But they won't really invest to create drugs for conditions affecting developing countries because the profit margin would be meagre. We come full circle.

Gestures of philanthropy towards the world's poorer nations, on the part of aggressively profit- seeking pharmaceutical companies, is to be taken with a grain of salt at the best of times. In a down economy, when pharmaceutical companies are merging for their own survival, full-blown skepticism is in order.