Tuesday, August 14, 2007

The ethics of health research and practice, postmodern style

It is not enough to do good; you also have to be seen to do good. Increasingly in biomedical research, and especially when conducted in the developing world, the challenge of ethically conducting a complex clinical trial is compounded by the need to control even the appearance of wrongdoing. In sensitive studies that inevitably lead to negative health outcomes for some participants -- such as HIV prevention research -- managing the appearances seems almost a quixotic endeavor. A recent article in PLoS Medicine describes reactions to the failure of a multi-site (South Africa, India, Uganda and Benin) trial of cellulose sulphate, a microbicide gel for use by women. In a major setback, the trial was stopped when it was unexpectedly discovered that more women became HIV-positive in the microbicide arm than in the placebo arm. The authors of the paper -- who led the trial -- describe the precautions put into place, the misunderstandings, attempts to allay fears, and lessons learned for future research. One sobering lesson of the article is that years of careful preparation on the part of researchers may be undone by an ambiguous phrase or uninformed media comments.
Clarity of communication among all stakeholders is essential, but hard to maintain, especially in settings where there is some suspicion towards biomedical research (particularly studies involving foreign researchers), and where lurid stories of 'third world exploitation' sell newspapers and increase hits on blogs. Of course, the authors of the article are partly defending their study and their response to its results, and not just describing them. There is no need to take their word on faith. But that is just the point: any suspicion of wrongdoing has to be backed up by evidence, otherwise there is a risk of undermining community trust and hindering promising medical research. That would be unethical itself.

In a similar vein, this week's Lancet carries a report of a deworming initiative in Ghana being derailed by community rumor and erroneous media reports. The initiative involved
trained teachers supervising the administration of a single 500 mg mebendazole tablet (imported by UNICEF) to nearly 4 and a half million children, aged 3–15 years in 28,043 public schools. Hours after the program started, there were reports on local radio stations about deaths and serious side-effects affecting several children in three administrative regions. These reports led to considerable public disorder. Some teachers were attacked and schools were shut. I will quote the part of the report describing the reaction of health authorities (the Lancet requires subscription):

The Ministry of Health immediately commissioned the independent pharmacovigilance centre at the University of Ghana Medical School to investigate. The investigators, in collaboration with the WHO Programme for International Drug Monitoring, found no deaths, three admissions to hospital for suspected Plasmodium falciparum malaria, and scattered reports of mild stomach aches, nausea, and cramps (known adverse events of mebendazole). The investigators also noted localized mass hysteria, including parents rushing their children to hospital or giving them palm oil in the belief that it would induce emesis, attacks on teachers by irate parents and carers, and attendance at hospital by over 350 children, all of whom were reassured and discharged. A possible source of the rumours was the emergency activities associated with the death of a child, killed by a falling wall, 2 h after the start of the deworming exercise. The report by the investigating team was presented by the Deputy Minister for Health at a press conference. The news that the Ghana Health Service had asked an independent team to investigate helped restore confidence and calm nerves. Other assurances came from UNICEF, which attested to the safety of the drug and widespread coverage of these findings in the print and electronic news media seemed to assure parents and calm the situation.


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