Research ethics as a sideshow

There seems to be a new approach to the publication of research studies that have been conducted in a questionable way from an ethical point of view, or are otherwise regarded as 'ethically hot.' Call it the pre-emptive strike approach: you still publish the paper, but you also simultaneously publish editorials that criticize the researcher's ethics. A way of having your cake and eating it too. The researchers and their scientific readership are happy, because they get to look at the data; the ethics people are happy-ish, because at least the problems with the study have been raised. I am reminded of the male circumcision and HIV studies in 2007, where an article was first rejected by the Lancet, and then subsequently published in PLoS Medicine with accompanying ethical commentary.

This time around, it is a tuberculosis treatment study. In the most current issue of the International Journal of Tuberculosis and Lung Disease, Aung et. al. describe how their operational research compared two treatment regimes, in order to evaluate the value of extending the intensive phase of anti-TB treatment for one month. The researchers did not ask participants for informed consent, arguing that: (1) neither of the treatment arms were likely to cause harm (2) the participants were be unlikely to be capable of making a rational choice to decide to participate (3) asking them to participate might lead to selection bias. The study was approved by the Bangladesh Medical Council Ethics Review Committee, and published by the International Journal of Tuberculosis and Lung Disease in full knowledge that informed consent was not sought. And published along with two (not one, but two) editorials that reject all three of the justifications given for not obtaining consent from participants.

So it goes. Another possibility would have been not to publish the article; a possible option now is to retract it. But I doubt this will happen. It seems that if an article looks sufficiently important, as long as the research was approved by an ethics committee (even if they admittedly dropped the ball), then it is acceptable to publish, as long as there is an accompanying ethics sideshow.

Failing to treat TB, until TB treatment fails

There are reports coming out of India of patients who have tuberculosis that responds to none of the existing drug regimes. When you have MDR (multidrug resistant) TB, the first-line drugs will not work on it, and your physician has to resort to second-line drugs that tend to be more expensive, less effective, have more side effects, and take longer to cure you from TB. When you have XDR (extensively drug resistant) TB, there is no point in you taking the first-line drugs as well as several of those in the second-line. Your clinical options and prognosis dwindle. Now there is the concept of TDR (totally drug resistant) TB, where patients are cast back into medical history, back to the time of the sanitorium and folk remedies.

TB is curable and, as is well recognized, failure to cure has to do with non-adherence to lengthy TB treatment, poor diagnostics, weak health care systems, and lack of political will. TB, in principle, could have been as prevalent today worldwide as polio. Instead, primary TB continues to kill millions every year, and if that is not bad enough, we now apparently have pockets of TDR in the world to control and contain. It is striking that a recent letter to Clinical Infectious Diseases states that systematically poor clinical management -- lack of medical ethics at the most basic level -- is helping to fuel TB drug resistance:

The vast majority of these unfortunate patients seek care from private physicians in a desperate attempt to find a cure for their tuberculosis. This sector of private-sector physicians in India is among the largest in the world and these physicians are unregulated both in terms of prescribing practice and qualifications. A study that we conducted in Mumbai showed that only 5 of 106 private practitioners practicing in a crowded area called Dharavi could prescribe a correct prescription for a hypothetical patient with MDR tuberculosis. The majority of prescriptions were inappropriate and would only have served to further amplify resistance, converting MDR tuberculosis to XDR tuberculosis and TDR tuberculosis.