Thursday, August 22, 2013

Research ethics scandal in Canada

So there we have our own research ethics scandal, and as is the habit with scandals, they tend to widen. Initially we learned that aboriginal children in the residential school system were subjected to research with nutritional supplements. Now we learn about even more exploitative clinical research. And the Truth and Reconciliation Commission is still digging.
Quite possibly this research was undertaken with the best of intentions, namely to improve the lot of malnourished aboriginal people. To some extent there seem to be parallels to research that is undertaken even today in some developing countries, where cheaper medicines are tested on impoverished trial populations because they are unable to afford the patented mainstream medicines that we take for granted.
There is an argument to be had that such research could be ethically acceptable if reasonable measures are taken to ensure that the trial populations will ultimately benefit from the research findings. After all, it is not the researchers’ fault that pharmaceutical companies price many life-preserving medicines out of the reach of the world’s poor. To blame them for trying to develop cheaper drugs to address genuine health issues seems unfair.
The intellectual property rights system leads to this unfortunate situation, and it should probably change, but it’s not something individual clinical researchers have any chance to influence one way or another.
Quite possibly similar motivations drove the researchers at the time in Canada. There they had a population that was severely malnourished. It was beyond their means to implement policies that would have ensured a supply of foods capable of ensuring a balanced diet for aboriginal Canadians living in remote areas of the country.
That the situation aboriginal people found themselves in was unacceptable is obvious, and the government of the day should be condemned for failing Canada’s aboriginal peoples. Where it gets trickier is to understand what exactly it was that made this research unethical. After all, quite possibly the motives were actually noble.
If it had turned out to be the case that nutritional supplements could have been a substitute for more expensive-to-provide regular food products, it might have been possible to improve the well-being of aboriginal Canadians. In all fairness, I am guessing here. I don’t know whether this is what motivated the researchers of the day. Even if it didn’t, this could have been a possible outcome. Unfortunately, the research (remember, it occurred during the 1940s and 1950s) wasn’t terribly methodologically sound, so it turned out to be time well wasted, even on that front.
A crucial issue in any kind of clinical research is the need for first-person informed consent, or consent given by a properly authorized legal guardian acting in the best interest of the potential trial participant who is unable to consent on her or his own behalf. A good example of the latter are underage people.
So, with regard to the research involving nutritional supplements, what exactly went wrong? For starters, consent was not sought and was not given. A clear no-go, certainly not only today, but also at the time. International standards at the time rightly declared clinical research with human participants in the absence of voluntary first-person informed consent unethical.
What else was unethical, even at the time? Withholding food (e.g. milk) from the involuntary trial participants to establish a particular clinical baseline for comparison was unethical. Not providing dental care to the involuntary participants in order to see clearer what impact the nutritional supplements or their absence would have was unethical.
Why was it unethical? It was unethical because the involuntary trial participants did not agree to the risk to their health. In addition to that: one principle of research ethics has always been that any worsening of a trial participant’s baseline needs to be well justified and is usually subject to some kind of compensation. For instance, today trial participants in sub-Saharan Africa who become HIV-infected in HIV vaccine trials typically receive a life-time supply of AIDS medication to compensate them for the harm they incurred as a trial participant.
The aboriginal Canadians received nothing to make up for the harm they incurred while they were reduced to the status of involuntary lab rats by government researchers.
Since the nutritional research was unearthed it has been reported that other research was also undertaken. This time it’s not just about nutritional supplements. It turns out clinical research was undertaken in aboriginal communities and residential schools. Again, informed consent was neither sought nor given. Incredibly, the drugs that were investigated were – insofar as they were successful – provided to the general population but not to the aboriginal communities without whose involuntary sacrifices they were made possible in the first place.
This kind of exploitation increases the ethics failures of those involved at the time quite significantly. Whereas in the initially reported nutritional supplement research we could have given the investigators the benefit of the doubt at least as far as their motives were concerned, we cannot reasonably do the same with regard to the now-reported clinical research.
What I find most disturbing about this widening scandal is that these events occurred right during the Nuremberg trials. Admittedly, there was no Internet at the time, but still, the crimes of the Nazi doctors in the German concentration camps were front-page news the world over. And yet, in Canada, at about the same time, a vulnerable, arguably captive population of aboriginal Canadians was essentially coerced into clinical research as if the reports about what happened during Nazi researcher Josef Mengele’s reign didn’t happen.
The 1947 Nuremberg Code established that first-person informed consent is essential for any clinical research involving human participants to be ethical. It is clear now that Canadian clinicians continued their research as if the worldwide outcry about the Nazi research never occurred. Nazi research happened in Nazi Germany; clearly that had nothing to do with their activities here in Canada, or so they must have thought.
There is a court order in place asking our government to turn over all related documents to these events to the Truth and Reconciliation Commission. This court order was issued in January. The Commission is still waiting for the relevant documents to be forwarded to its staff. Given that the Commission’s mandate expires in less than a year’s time, time is of the essence.
Udo Schuklenk holds the Ontario Research Chair in Bioethics and Public Policy at Queen’s University. Follow him on Twitter @schuklenk

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