Pregnant women with malaria are not given the most effective drugs during their first trimester. Why? It's contraindicated.
"We need to ask 'why?' again to get to a deeper answer," insists Dr. Phaik Yeong Cheah, Head of Bioethics and Engagement at the Mahidol Oxford Tropical Medicine Research Unit (MORU) in Thailand. She believes "contraindication" is often an indication not that the drug is dangerous but that research is lacking.
Born in Penang, Malaysia, Dr. Cheah fell in love with clinical research during her PhD work in Pharmaceutical Technology at the Universiti Sains Malaysia. From 2008 until April 2015 she led the clinical trial support group at MORU and since then she's trained hundreds of researchers throughout Southeast Asia on ethics and good clinical practice. However, Dr. Cheah's 15 years of experience working with vulnerable populations--most recently in Southeast Asia with migrants and refugees at the Thai-Burma border--and her position as Research Associate at the University of Oxford's Ethox Centre, have also positioned her as a thought leader in the field of bioethics.
As global health professionals focus their attention on the burgeoning drug-resistant malaria crisis happening at the Thai-Burma border, Dr. Cheah has taken this as an opportunity to pivot her attention to asking why. Why aren't the pregnant women refugees with malaria given the best malaria drugs available? Why are the refugee children, some of the most vulnerable of peoples, so frequently excluded from participating in research designed to better understand their situation and ultimately help them?
I caught up with Dr. Cheah to ask her a few questions on these topics, as well as about her controversial article in Asian Bioethics Review, Are Children Always Vulnerable Research Participants?
In your article you take issue with using "vulnerable" as a blanket categorization of people. Can you tell us where this vulnerability box comes from and why you see it as problematic?
"The scientific community has, for good reason, traditionally viewed certain populations as vulnerable. This has included children, prisoners, refugees and ethnic minority groups, and others who are at risk of being exploited. However, I think some of this is a reaction of the wrongs in medical research that have occurred in the past. But I do think vulnerability is context specific. For children as well as other groups in the vulnerability box, classifying them as vulnerable and protecting them from research means that they are deprived of evidence-based medical care, which makes them even more vulnerable. We should be protecting them through research not from research."
Your work has included conducting research with and about refugees at the Thai-Burma border. These are stateless peoples with few rights. How do you respond to those who say you are exploiting their vulnerability?
"I think we first have to ask ourselves why they are vulnerable. It may be because they have limited access to medical care or they feel that their willingness to volunteer in a study is compromised because of real or perceived fear of the repercussions. Researchers must be aware of that and act accordingly. For example, when asking volunteers to participate in studies we must ensure that their consent is valid--that their decisions and actions are truly voluntary and in no way coerced. Of course the research must be justified; it must be responsive to their health needs."
You believe that not conducting research on vulnerable populations because they are vulnerable actually makes them more vulnerable. Can you give us an example of this?
"A specific example is the antimalarial drug piperaquine. It has been recently established that there has been under-dosing in young children, which caused treatment failure. And this is because its dosing recommendations for children were extrapolated from adults and older children."
You've said that pregnant women with malaria do not receive the best drugs during their first trimester because they've been excluded from research. Is this an issue of causing risk to the mother and the fetus or something else altogether?
"I think not conducting research with pregnant women means that we are using drugs in clinical care without sufficient evidence. And of course this puts both the mother and fetus at risk. At the moment the best treatment for malaria, artemisinin-based combination therapy, is contraindicated in pregnant women during their first trimester. Why? Because until recently there was no data."
Lastly, it seems that many researchers view ethics as a field that severely limits the effectiveness of their work. Do you believe this is the case?
"I think researchers are increasingly recognizing that identifying and addressing ethical issues in their clinical trials doesn't limit their work. It actually enables it by ensuring better quality research can be conducted."
This article was supported with funding from the International Reporting Project.