Malaria vaccine fever

On October 19, 2011, in Gates Foundation, immunology, malaria, vaccination, by Karen Grepin

I unfortunately had to miss the Malaria Forum being hosted by the Gates Foundation in Seattle this week. For the past 2 weeks, my household has been suffering from NYCPV – the dreaded New York City Playground Virus – and when the time came to get on my flight I was voiceless and feverish. I figured I should spare my colleagues my presence…and my germs.

While there was lots of good stuff discussed at the Forum this week, most of it has now been overshadowed by the announcement of interim phase III trial results of a subunit vaccine for malaria, known as RTS,S. The interim results line up with what most people who have been following the saga of this vaccine over the years would have expected, a roughly 50% protective efficacy against cases of malaria and a roughly 35% reduction in cases of severe malaria in young children roughly 12 months after the vaccines were given (I prefer the intention-to-treat results, not the higher per-protocol results that many in the press have been reporting instead). This is clearly very good news…and something no doubt worth celebrating.

That said, and unlike the rest of the world which seems to have gone crazy celebrating this news, I can’t seem to get too excited about these results, at least for now. Sure from a scientific perspective this is really groundbreaking: we now have a vaccine against malaria that has shown to be somewhat effective in a phase III trial. It is also a vaccine against a parasite, which itself is a big accomplishment. Peter Hotez released a press release earlier today in which he describes this news as the equivalent to walking on the moon in terms of its scientific contribution. Wow.

But as a public health professional, I just don’t think that enough new evidence has been presented for us to think that we found a “game changer” when it comes to malaria prevention and control. The real question, at least in my mind, that is relevant in this discussion is: does this vaccine provide any real lasting immunological protection in the target populations? The interim study was not set up to address this question. The actual full study was but, and I am not entirely sure why, the interim results were published anyway years before the real results of this study are going to be known. I am not the only one who questions the merits of this approach, in the accompanying editorial in the NEJM by Nicolas Witte, a true expert in this area, said “there does not seem to be a clear scientific reason why this trial has been reported with less than half the efficacy results available”. But of course we all know it is not always just science that drives most scientific discussions.

What this study showed was that up to 12 months there was a reduction in the cumulative number of cases of clinical and severe malaria in those receiving the treatment vs. those that did not. Unlike traditional vaccines, immunization in this case does not prevent infection per se, it might just delay it or delay the clinical manifestation of the symptoms. We don’t know. Even this study showed that the efficacy of the vaccine had already started to wane before the end of the interim study. The initial study includes a booster vaccine to be given at a later date to help boost immunity – this might be key to proving the value of this vaccine. I will wait to celebrate until after I see the results of this part of the full study.

But shouldn’t we celebrate all new vaccines? I think this might be an example of where the public health community is so trained to believe in the power of vaccines that there is little questioning of whether a new vaccine is better than none. In this particular case, I am not so sure. By the way, I blame Bill Foege’s excellent book “House on Fire” for making such a skeptic when it comes to traditional public health dogma and vaccination.

I’ve seen two interesting papers in the past year that look at the use of intermittent preventive treatment of children that showed incredibly high levels of protection (you can read more about them here on the topnamen malaria blog) in areas of high disease transmission. Will this vaccine be better than that option? Those drugs are available now.

When I travel I take a prophylactic drug to prevent malaria, would this vaccine be a better option for me than what I currently do? I would likely need 3-4 shots of the vaccine, which seems like a pain compared to my one pill a day. Is this why GSK has been so quick to say it will not try to capture profits from this new product?

I have heard talk recently of using more powerful drugs like ACTs, which are also known to block transmission, in a mass drug administration type way to dramatically reduce community levels of the disease. Would this not be worth trying?

Is this the best vaccine in the pipeline or just the furthest along? If the world commits itself to this particular vaccine would there be a risk of slowing the speed of development of a better vaccine? Why was there so little discussion of this paper published last week in Science that shows promising results from a live attenuated vaccine in preventing infection.

Would a vaccine work better in areas of low of high transmission?

To be clear, this is an exciting scientific discovery. Kudos to the authors of this paper and to the countless others who have been involved with this venture for decades for their excellent scientific work. But in my mind there are still a lot of big unanswered questions before decisions can and should be made about using this vaccine in the real world.

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Stuff on the net

On August 15, 2011, in links, by Karen Grepin

I have not done one of these posts in a while, I think because I have largely substituted tweeting for rounding up the links I have enjoyed reading in the past few days and sharing them on the blog. But the urge came over me tonight to put some of the things I have read recently up here to draw attention.

1. The last mile in global poliomyelitis eradication: Dr. Bhutta from Pakistan, a prolific researcher and writer, shares some thoughts on why the last phase of polio eradication is so hard. These are really complicated issues and so I am impressed with how this one short piece seems to capture most, if not all, of these issues and makes them very easy to understand. I wish more technical people could write like this.

2. Global Rise in C-Sections Troubles Experts: I’ve started doing some work lately on the rise of cesarean sections in the developing world, which in a nutshell has been dramatic in some places. Many experts are alarmed by the rates. While there is no consensus on what the rates are, there is even less of an understanding of why the rates are rising so rapidly. PBS investigates these questions here.

3. A Campaign to Carry Pregnancies to Term: Back here in the US, another consequence of high rates of cesareans here are that many pregnancies are induced or scheduled for cesarean section before the baby is full term. There are health consequences of these decisions and the March of Dimes has recently launched a campaign to promote full term births called “Healthy Babies are Worth the Wait”. You can read more about this campaign in this NYTimes piece.

4. Partners in Help: Finally, Paul Farmer who is currently promoting his new book “Haiti: After the Earthquake”, reflects on Haiti, Harvard, and foreign aid in general in this piece, which was essentially his commencement address at Harvard Kennedy’s School earlier this year. While I certainly agree with a lot in this piece, I am not always convinced that the solutions are as obvious as he would make them seem. But I thought this was a thoughtful and interesting read.

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What I will be teaching this fall

On August 3, 2011, in NYU, by Karen Grepin

I know there are still a few weeks before labor day, but already I have started to get myself organized for another semester of teaching at NYU-Wagner. This fall I will once again be teaching “Introduction to Global Health Policy”, an NYU-Wagner course for students in the Health Policy & Management MPA or any student with interests in the topic from other programs at Wagner or across NYU.

I will also be teaching “Introduction to Global Health Policy and Management” which is a required course for the students enrolled in the Global Health Leadership MPH program at NYU.

As a relatively new instructor, I am always looking for ways to improve upon the course from the previous year to make the classes most useful to students. That is why I was *thrilled* to find out that the Global Health Delivery Harvard Business School case studies that I have been hearing about for the past little while are finally launched and ready to go. In total they have put together 21 global health themed courses to help with the teaching of important global health issues, ranging from manufacturing of textiles for malaria control to dealing with the aftermath of the Haiti earthquake.

The best part of all of this? The cases are free!

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Great idea…but will it save lives?

On July 25, 2011, in Uncategorized, by Karen Grepin

I am on my way down to DC to attend the Saving Lives at Birth Development Expo and Exchange. I am part of a research team that is a finalist for one of the integrated grants. Our partner, Changamka, is an impressive organization that has developed microsaving products to enable people to save money for health services to use when they need it. In addition, they are currently developing a mobile phone enabled version of their product specifically for pregnant women to help pay for maternity services, including antenatal, delivery, and postnatal care: mhealth meets microfinance!

You can find out more about Changamka by watching this moving video, which was produced by Al Jezeera:

Seems like a great idea, right? I think so, but of course, we won’t actually know until the program is properly evaluated. There have been many great and noble attempts to reduce financial barriers to maternity services. In fact, introducing voucher programs or user fee exemptions have become extremely popular across sub-Saharan African countries to expand access to maternal and child health programs.

Despite all of the fan fare that these programs have received (including this piece in the NYTimes last week chronicling the experience of Sierra Leone) it is not clear if we really know if these programs really work and under which conditions. Most of the programs have not been evaluated. Even if we do believe that they are effective, given that they are hugely expensive programs, it would also be good to know if they generate enough impact to justify the resources expended on them. These are all things that we believe we will be able to better understand with our proposed project.

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The masterful marketers at the Gates Foundation have put the following video together to raise the profile with what is probably one of the most important and least sexy issues in global health – how to get billions of people to poop in the right place. Their idea: the world needs a need toilet that is better suited to resource constrained environments – in their words the Toilet 2.0.

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A couple of months back, you may have seen some publicity for an exciting new grant program launched by USAID, the Gates Foundation, Norway, Grand Challenges Canada, and the World Bank called “Saving Lives at Birth” – a Grand Challenges program to find and scale-up innovative solutions to reducing both child and maternal mortality in low income countries.

Stop for one minute and think about it: if you could do something tomorrow, what would you do to save the lives the millions of children and women who die during childbirth?

Well if you can’t decide yourself, you can share your views on what others think might work. There were over 600 applications to this program and from the initial list of applications, 77 projects have made it to the final round. Some of the projects have been submitted for smaller proof of concept grants while others have been submitted for larger integrated solutions that can be brought to scale and evaluated for impact. The organizers are asking for your opinion – which of these programs would you support? Next week in DC there will be a Development Expo where the finalists will be displaying their ideas. Projects with the most votes are eligible to win a people’s choice award.

Full disclosure: while I wanted to help get word out about this program, I also wanted to let you know about some of the work I’ve been doing the past few months. I am part of a team that was selected among the finalists for this program. Working with an amazing health microfinance organization in Kenya – called Changamka – and some economists from Georgetown, we are proposing the development of an e-voucher that can be deployed by mobile phones in rural areas of Kenya that will subsidize the costs of maternity services. In addition, we are also proposing a series of informational interventions, which we believe can be cost-effective means of increasing demand. Most innovatively, we are also proposing the development of a crowd-sourced application that allows users to share information on the quality of health services received. And we have developed a plan to rigorously evaluate it to see what really works and why. If you like our ideas, I can promise you a free subscription to my blog for life. :) Go vote – and vote often!

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I wanted to bring to your attention another special supplement that I think will be of interest to many readers of this blog. Sponsored by ICAP, the Journal of Acquired Immune Deficiency Syndromes has released a special supplement on the topic of HIV and Health Systems.

As you all know the scale up of HIV programs in low-income settings has been unprecedented in global health and by most metrics incredibly successful. While others, including myself, have wondered if the ends have really justified the means. There are no easy answers to these questions and so the debate continues, many of the articles in the supplement further this debate. All of the articles are available to readers free of charge.

The success of the HIV programs has lead many to wonder whether these investments should be used to begin to deliver a broader package of health services. Many of the articles talk about the prospects of integration of other health services, especially non-communicable disease services, through existing HIV infrastructure. I have an article in this supplement where I caution against moving forward with these well intentioned efforts without fully considering the potential trade-offs.

The supplement will be officially launched this upcoming weekend a special pre-IAS conference meeting on HIV and Non-Communicable Diseases. Sadly, I won’t be able to attend, but I am looking forward to getting updates on the debates.

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As a follow-on to my post yesterday, I also wanted to link to a special supplement of Health Policy and Planning that was released last week that contains more research articles on the role of the private health care sector in various international contexts.

I particularly enjoyed the review of the role of the private sector in the delivery of vaccinations in low income countries, an activity that I have always ascribed exclusively to the public sector. I think this further emphasizes the point I tried to make yesterday: that efforts to improve health in low income countries need to be aware the role the private sector is playing and needs to engage them as appropriate.

Here is a list of the articles, all of which are free to download (Kudos HPP), contained in this supplement. Happy Reading!

B C Forsberg, D Montagu, and J Sundewall: Moving towards in-depth knowledge on the private health sector in low- and middle-income countries

Ann Levin and Miloud Kaddar: Role of the private sector in the provision of immunization services in low- and middle-income countries

Anna Heard, Maya Kant Awasthi, Jabir Ali, Neena Shukla, and Birger C Forsberg: Predicting performance in contracting of basic health care to NGOs: experience from large-scale contracting in Uttar Pradesh, India

Sachiko Ozawa and Damian G Walker: Comparison of trust in public vs private health care providers in rural Cambodia

Bruno Meessen, Maryam Bigdeli, Kannarath Chheng, Kristof Decoster, Por Ir, Chean Men, and Wim Van Damme: Composition of pluralistic health systems: how much can we learn from household surveys? An exploration in Cambodia

Gerald Bloom, Hilary Standing, Henry Lucas, Abbas Bhuiya, Oladimeji Oladepo, and David H Peters: Making health markets work better for poor people: the case of informal providers

Ha Nguyen: The principal-agent problems in health care: evidence from prescribing patterns of private providers in Vietnam

Nirali M Shah, Wenjuan Wang, and David M Bishai: Comparing private sector family planning services to government and NGO services in Ethiopia and Pakistan: how do social franchises compare across quality, equity and cost?

Sara Sulzbach, Susna De, and Wenjuan Wang: The private sector role in HIV/AIDS in the context of an expanded global response: expenditure trends in five sub-Saharan African countries

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I am currently in Toronto, Canada where I am attending the biannual International Heath Economics Association conference. It has so far been two very full and engaging days of running from session to session and catching up with colleagues and friends from around the world.

A few days before the conference, I also attending a special one day session on the role of the Private Sector in Health. What was clear from attending these sessions is that the private sector is currently playing an important role in health service delivery in most developing countries and therefore any health system intervention aimed at improving health service delivery must at least figure out how to engage with this important part of the sector.

The conference was a research conference so there were papers presented on what do we know about this sector, how is it changing, and experiences some actors have had working within or with the private sector. The powerpoint presentations from this conference, including one by a particular blogger who knows very little about this topic, have been uploaded here and are available to all to view.

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Last week, I attended a conference in Rabat entitled “Reducing Maternal Mortality in Morocco: Sharing Experiences and Sustaining Progress”. Morocco is one of the few developing countries that can legitimately argue that it is on track to achieve MDG5 – a three quarters reduction in maternal mortality from 1990 to 2015 – so I was very excited to get first hand knowledge of what I could learn from the Moroccan experience that could then be generalized to other countries.

In the early 1990s, the maternal mortality ratio (MMR) in Morocco was estimated in the vicinity of 330. According to the most estimates, the MMR in Morocco is now around 112 – which means that they have reduced their MMR by a whopping 60%! Much of the reduction has actually taken place during the past 5-7 years, coinciding with intensified efforts on the part of the government to reduce MMR. Given its trajectory, many people think that it will be able to go the rest of the way and actually achieve MDG5.

At this point I am sure a lot of you are thinking about measurement and data issues and whether or not we can actually say that Morocco has reduced its maternal mortality. This is a valid concern (and one which will plague all assessments of performance against MDG5) but all of the currently available sources of data on the MMR in Morocco seem to suggest that real declines have occurred: the UN Intra-Agency estimates, the IHME estimates (i.e. Hogan et al. 2010), and Morocco’s own estimate all point to similar trends.

So how did Morocco do it? After decades of incremental efforts there was a big shift in priority given to maternal mortality in 2008 when the government launched the ambitious strategy for accelerating reduction in maternal and child health (PARMMI). The strategy involves three major components: addressing physician and financial barriers, improving quality of care, and improving the management of governance of the programs themselves.

The government implemented just about every programmatic activity that has ever been thought to be effective using a “whole-of health-systems” approach: making obstetric care free, rolling out ambulances, training of health workers, increasing the number and distribution of health workers, implementing a mobile phone enable monitoring system, launching efforts to improve service quality, increasing awareness of the issues, and dramatically strengthening the information base available to the government to monitor progress. This last point also included a very intensive effort to track and audit all maternal deaths – a system one international expert called the “Cadillac” national maternal mortality surveillance system. They did it all and they did it quickly and effectively using resources from mainly the government but also from their development partners.

Given the number of interventions that were simultaneously launched it is difficult to tease out exactly what work, when, for whom, and why. The academic in me me wished there had been more evaluation of their experience and was left really wondering which interventions had been the most effective and why — but we we may never know.

But I did not leave the country disappointed as in the end I did learn why Morocco was able to achieve such a miraculous decline in maternal mortality: strong political commitment. During the conference the Minister of Health, a young woman not too much older than myself, stated that maternal mortality was the most important priority that her Ministry was attempting to address. So much so that victory for her was not achieving MDG5 but rather achieving an even lower MMR that she felt was more appropriate to their level of development. What sets Morocco apart from many other developing countries is the extent to which they have placed maternal mortality on the top of their list of priorities and have exerted significant effort and allocated substantial resources towards the issue. For maternal mortality, it seems that if there is a will, then there is a way.

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