Can an ART a day keep the doctor away?

On November 23, 2010, in HIV/AIDS, prevention, research, by Karen Grepin

Interesting results of a trial that looked at the Pre-Exposure Prophylaxis (PrEP) – essentially uninfected people taking a drug prophylactically – on new infections from HIV were released earlier today in the New England Journal of Medicine.  Roughly 2500 male and transgender men who have sex with men (high risk uninfected) in the Americas, South Africa, and Thailand were randomized to receive a once daily combination pill of emtricitabine and tenofovir disoproxil fumarate (FTC–TDF).  After about a year and a half, about 100 people developed new infections from the virus but the treatment group experienced a roughly 44% decreased risk of new infection.  This is pretty exciting news, as there is a clearly the need for new effective methods to prevent HIV.

I know it is coming…so I’ll weigh in on this question.  So if this works, why not just distribute the drugs to everyone in highly affected countries?  While exciting news, I think there are a number of drawbacks of that might prevent this approach from being more widely adopted at the general population level.  
First, these are heavy drugs, the trial itself found relatively high levels of adherence problems, and I am not an expert in this but I’ve always had the impression that most ART drugs are not the kind of thing people want to be taking unless the alternative (death) is severe.  
Second, we need to consider the whether this represents a good use of resources. This trial was conducted in a very high risk population and even then the risk reduction was only about half.  Depending on how costly these drugs would be, plus the associated medical costs of ensuring some medical follow-up of people taking these drugs, it might not be cost-effective relative to other prevention strategies in the general population.  
Third, we must also consider drug resistance.  Although no drug resistance was detected among those patients who developed HIV during the trial, resistance to these particular medicines can be developed and could potentially have widespread effects on overall usefulness of ART medicines.
Fourth, we must also consider the behavioral effect of these drugs on patients.  The overall trial would have picked up short-term behavior effects (e.g. if people think they are protected they may engage in more or more risky sexual behavior) but we should worry about is the more long term effects of this intervention on behavior, say over time or outside of a trial setting.  Depending on how large this effects might be, it could undermine the overall effectiveness of the strategy.
Finally, PrEP is not a magic bullet.  There are other ways of becoming infected that are unlikely to be affected by this drug (e.g. injections) and the reduction was far from complete.  Plus, unlike other prevention methods (e.g. condoms) it does little to protect against other STIs.  
But of course anything that helps in preventing this horrible disease, even a bit,  is very good news.
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The subtitle of the First Global Symposium on Health System Research, which is currently underway in Montreux, Switzerland is “Science to Accelerate Universal Health Coverage (UHC)”.  There has been a lot of talk about the concept of UHC specifically of what we mean when we use the term, how much it would cost to scale it up, and what are some of the potential benefits from widespread adoption of UHC in many low and middle income countries.   While there is no one common definition of what we mean when we say UHC (in fact, one of the background papers for the conferenced identified over 20 different definitions) the basic idea is the concept that citizens having access to essential health services with no major financial obstacles – but you can see how complicated it becomes when we try to apply this definition to the plethora of countries approaches to UHC.

Definitions aside, one of the things I have been struggling with throughout these discussions is the idea that the adoption of UHC in these countries can be “accelerated”.  One of the goals of the conference is to “develop a global agenda of priority research on accelerating progress towards universal health coverage”.   The way people talk about UHC around here it is as if it is something that can be “scaled-up” or “implemented at the national scale” or “promoted for widespread adoption” – you’d think we were talking about adding another vaccine to current immunization schedules or adopting a new drug.  It seems achieving UHC is the latest and greatest health intervention that needs to be rolled out.

But how does one even begin to try to answer the question of what can be done to try to accelerate health coverage in countries where UHC is not currently the norm? Well, one quite logical approach could be to look at the countries that have achieved UHC, or at least have made important steps in the direction of UHC, and ask what they did right.  I’ve seen a lot of good research that has been presented here that have looked at this question.  But of this course this research methodology might lead us to very biased perspectives about what works if we don’t also include the countries that have attempted to implement UHC but have failed.  There are some good examples of those countries as well, but those discussions have been much less prominent during this week’s conference.  I think this is a mistake – we need to be more rigorous in our anaylses.

Another methodology that could be useful, and perhaps one that has been underexploited in the area of global health policy is to use history to inform our perspective.  Jesse Bump, a historian and a current a fellow at the Harvard School of Public Health, presented a fascinating paper on this topic yesterday at the conference.  Using the case of Germany, the United Kingdom, and the United States he explores what historical lessons can be useful to inform current debates on UHC.  As well, in his paper, he also explore how efforts to promote UHC through external assistance and influence have succeeded or failed using the social medicine movement and the Bandoeng Conference of 1937, the Primary Health Care movement and the Alma‐Ata Conference of 1978, and the Selective Primary Health Care movement of the 1980s as case studies.

Briefly, Bump finds that the successful UHC efforts in both Germany and United Kingdom were driven largely from internal efforts that had to do with broader social changes and happened at the times where there were opportunities for large scale renegotiations of the social contract within these countries.  Also worth pointing out, these were very lengthy and complicated processes within each of these countries – it took well over a hundred years in Germany.  I learned on Tuesday that it took nearly 27 years to do the same in Thailand.  Finally, he also finds that all 3 externally driven efforts have failed and that “so far all countries that have achieved UHC have done so through organic, domestic processes, which necessarily reflect local historical, cultural, and institutional legacies”.

The main criticism that can be lobbied about historical perspectives is the generalizability of previous experiences with future experiences.  Although he does include both successful and non-successful efforts, it is never clear how much context in the past is relevant today.  But his work raises some really interesting questions regarding the idea of promoting or accelerating the adoption of UHC.  I am left wondering to what extent UHC efforts be promoted by external actors and what place they should play in this processes?  To what extent do countries need to be ready – whatever that means – to promote UHC?  Are we once again setting ourselves up for failure by setting unrealistic goals of achieving really large and complicated health reforms in a short time period?  History suggests that the journey to UHC, if such a path could be traced out, is likely to take place a long and bumpy road.  Perhaps a more realistic area of research is what can the research community do to at least make this trip a bit more enjoyable and to avoid some inevitable wrong turns – and road kill.

Photo Credit: misspudding

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The First Global Symposium on Health Systems Research officially kicked off this morning is idyllic Montreux, Switzerland.  Throughout the day yesterday, there were a number of interesting satellite sessions  where meeting participants were able to have smaller discussions prior to the launch of the overall conference on more specific topics.  I briefly attended two sessions, one on the measurement of indicators for tracking policy and heath system indicators for maternal, newborn, and child health (MNCH) and another wherein the Rockefeller Foundation launched a new report, entitled Catalyzing Change, which is a report commissioned by the Foundation from the management consulting firm McKinsey (of which I am an alumnus) to look at the question of how much it costs –  specifically the “system costs” –  of scaling up health insurance to the national level in a select group of countries.

During the first session the meeting participants spent a great deal of time discussing the pros and cons of various MNCH indicators and the challenges associated with attempting to deduce the effectiveness of policies aimed at improving these indicators.  In the second session, the authors of the report argued that by their assessment the health system costs of expanding health insurance coverage in a select group of countries are “relatively small”.  What struck me after attending these two, relatively distinct discussions, is just how difficult it is conduct good and meaningful health systems research – the focus of this conference – when the outcomes that most people would agree that health systems should target – reductions in mortality and morbidity, improvements in financial risk protection, and improvements in patient satisfaction – are so imperfectly and so incompletely measured – if they are even measured at all.

As health system researchers we are severely limited in what we are able to monitor so when end up focusing on what we can measure: frequently process indicators such as the number of people with health insurance coverage or the proportion of women who receive four or more antenatal care visits.  But sometimes we forget that these are just indicators, which we think might influence the outcomes we care about but this may not always be the case.  They are means to an end but not the end in itself.

We should only care that people have health insurance coverage if having this coverage improves health, reduces the proportion of households who suffer financial impoverishment as a result of a sick family member, or improves patient satisfaction with the services they are receiving.  Just having a health insurance card is not enough.  We should only care if women receive four or more antenatal care visits if these visits actually are effective at improving the mother during her pregnancy, reduce maternity related morbidity and mortality, and improve neonatal and child health.  Standing in line for a few hours to speak to a low quality health care provider – or worse to find out that the provider is not present – is not particularly useful, and might represent a significant waste of public resources.

It the absence of such data, we will continue having to make the assumption that higher levels of coverage of these indicators are making a difference.  But as we all know, making assumptions can frequently lead to an incorrect or an incomplete view of the picture.  My big hope from this conference will be a frank discussion of how data collection efforts about health system outcomes can be improved and strengthened around the world.

Sometimes small efforts can lead to big improvements in data collection efforts, such as asking about patient satisfaction, collecting information on household incomes and expenditures, or just getting more detailed data on the patients presenting and the services provided (e.g. quality indicators).  The incremental costs associated with adding these additional dimensions to existing data collection efforts may not be enormous but the incremental benefits from such efforts may be large.

Nandini Oomman recently asked in a blog post on the Center for Global Development’s Global Health Policy blog about whether research can make health system strengthening sexier, but I am left wondering if health system research itself will ever be sexy enough for the needed investments in data to be made?

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All of next week, I will be in Montreux, Switzerland participating for the First Global Symposium on Health Systems Research.  I am a health systems person so this is the kind of a conference that people like me live for.  Thanks to support from the World Health Organization, the conference organizers, I also plan to be tweeting and blogging from the conference on the cutting edge heath systems research that will be presented.  I hope I can do the excellent research that will be presented justice.

To give you an idea of some of the sessions, here are a few previews:

  • On Monday, the Rockefeller Foundation will release a new report: Catalyzing Change: The System Reform costs of Universal Healthcare, the first ever report that analyzes the costs of putting the infrastructure and systems in place to permanently shift healthcare spending from out of pocket to a universal and social insurance model.
  • On Wednesday, Rifat Atun from the Global Fund will be giving a the Health Policy and Planning annual lecture entitled “Global Health and Health Systems at a Crossroad”.
  • Julio Frenk will be giving the keynote, entitled “Health Systems Research for the 21st Century: The Power of Knowledge in an Interdependent World”.  I’ve seen him give a variation of this talk a few times, but I don’t know why, I always find him so inspring.
  • Atul Gawande will give a talk called “Why Health Systems Fail”.  Love it.

If you are also planning to attend, let me know.  Perhaps we can organize a tweet-up or get together over fondue one night!

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A conference is going on in DC this week that is investigating the potential of mobile technologies and health service delivery in the developing world – aka mhealth. This concept has been much hyped and discussed for many years.  It is well known that the take-up of mobile phones has been phenomenal across the developing world and the availability of this technology has been seen as a potential platform to help delivery additional health information and education to patients.  But does it work?

A new paper in the Lancet investigates the potential of short messaging service (SMS) to increase adherence to antiretroviral therapies in Kenya.  New ART patients presenting at clinics in Kenya were randomized to receive weekly reminders from nurses to take their medications.  The patients were required to reply to the nurses.

The study did find significantly higher rates of reported adherence and significantly higher levels of viral suppression among those receiving the SMS messages.  Both too really good pieces of news.  On the negative side, neither arm of the study showed particularly high levels of adherence and both arms suffered relatively high levels of attrition.  So while it helps, it does not necessarily solve the problems of adherence or attrition.

SMS technology is relatively cheap and the findings of these study show that the use of this technology has the potential to be an important complement to existing efforts to promote health education and proper use of health services in developing countries…. L8R

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Five weeks from now the global health community will be celebrating another big and important milestone: a new vaccine against meningococcal A meningitis – MenAfriVac – will be distributed in three of the hyper-endemic countries of what is known of as the Meningitis Belt in Africa.

What is particularly notable about this achievement is not just that a new vaccine against a major child killer but that 10 years ago this vaccine did not exist, and it seemed quite unlikely that such a product would ever exist but thanks to a remarkable partnership, not only does this product exist but that it has been made affordable enough for widespread distribution.

When I was an undergraduate student in immunology at McGill, I remember a lecture from one of our professors on meningococcal A meningitis.  Just a few years prior there had been a major epidemic of the disease throughout the meningitis belt and there had been a major epidemic wherein 5,000 people died and more than 250,000 had been sickened by the disease.

The kind of vaccine that is required to produce a good immune response in those most vulnerable to this disease – a conjugate vaccine – requires relatively sophisticated technology to produce and since this strain of the bacteria really only causes significant illness in the developing world the prospect of a new vaccine were not promising.

The following case study on the PATH website presents an interesting example of how a public-private partnership for new product development can be successful.  I encourage you all to have a look.  Celebrating these great milestones is what makes me so love what I do for a living.

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