Two weeks ago my advisor and I appeared before Cornell's Institutional Review Board (or IRB in academic speak) to defend our research proposal. All studies involving humans or animals must be reviewed and approved by a panel of university faculty before they can begin. The IRB ensures that risks to the participants are minimal and that provisions are in place to respond in cases of emergency.
Sometimes the IRB approval process is quick - you are approved in 1 or 2 weeks. In our case it took almost 4 months. What was the root of the delay? Peanuts...or more specifically the risk of peanut allergies in young children. Our study involves introducing a peanut-based nutritional supplement to infants starting at age 6 months.
All of you parents of young children are probably nodding your heads. Current American Academy of Pediatrics recommendations are to wait to introduce peanuts until a child is 3 years old. Evidence suggests that rates of peanut allergies have more than doubled in the last decade to 1-1.5% of US children. Peanut allergies are particularly frightening because they can be deadly - and sometimes dramatically so.
In contrast, no Haitian I've talked to so far has ever questioned why we would feed peanuts to young children. Peanuts are grown in Haiti. They are a common food - eaten whole or in the form of a spicy peanut butter spread on bread. A friend who works in rural Haiti said that kids receive locally made peanut butter when they are as young as six months old. People out in her community had never heard of a child getting sick or dying from eating peanuts.
(There is generally accepted but still unproven theory that almost all allergies are lower in populations where children are not slathered with antibacterial soaps or transported in covered strollers that keep them from interacting with the pathogens in their enviornment. Reports from Haiti and Malawi have shown only one case of eczema in more than 10,000 kids treated with the fortified peanut butter we will be using).
Which brings me back to the Cornell IRB - an IRB that cares about protecting kids in Haiti, protecting Cornell as an institution, and protecting me as a researcher. The IRB wanted to know why we would do a study in Haitian children that goes against the American Academy of Pediatrics's guidelines. The fundamental piece of our response was that in Haiti, a country where almost 25% of children suffer from chronic malnutrition, the uknown but seemingly incredibly small risk of dying from a food allergy is just not reasons enough to not go ahead with the trial (with as many safeguards as we can provide)....
It's not only scenarios like that in the movie The Constant Gardner - where TB drugs with known terrible side effects are being tested on Kenyans without due consent - that cause us to question the ethics of research in developing countries.
It's the fact that if we were doing the same nutrition study in the US we could almost 100% guarantee that a child in our study would have access to emergency care at any time including inexpensive life-saving treatments such as an "epi-pen" that are needed to stop an anaphylatic reaction. Help is only a 911 call away.
In Port-au-Prince, a metropolitan area of 3.5 million people, there are fewer than five sites that provide 24-hour medical care. Only 1 or 2 of these emergency sites are likely able to maintain a consistent supply of even the most basic drugs. There is no 911 or ambulance services - most won't have access to any private vehicle at all. We will have everything needed at GHESKIO's downtown clinic - but it's only an outpatient referral site open from 8-4:30pm from M-F. That doesn't help the one mom whose child can't breathe at 11pm.... a mom who if she lived in Palm Beach, instead of P-au-P, would be able to access care for her child.
If it sounds like I'm quickly moving from the ethics of feeding peanut butter to small children to more fundamental questions of global inequality, poverty and injustice - it's because I am, it's inevitable.
Perhaps over your next PB&J you can think about it some more and share some of your thoughts with me!
(PS - I had started this post before I left and wantd to get it up. I promise to post something about life now that I am here in Haiti sooner than later.)
Sunday, October 21, 2007
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2 comments:
Questions: Are you planning to use Plumpy Nut produced by Nutriset? Will it be produced locally? Are you partnering with any organizations in Haiti? How broadly will it be distributed?
Thanks for your comment. We are a locally produced version of plumpy nut being made by Meds and Food for Kids (MFK) in Cap Haitien. Their factory and process process was reviewed and approved by nutriset. The clinic where I am working is the only site I am aware of in Haiti that is using a preventive approach with the product (we are actually reformulating the manba to reflect this) MFK is provding mediak Manba to a number of other organizations here in including the Childrens Nutrition Program in Leogane and Justinian Hosptial in Cap Haitien. MFK and CNP are google-able.
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