Ethics “experts” and clinical trials
Posted by Henry Bauer on 2009/02/02
Ethical and other problems have been prominent with clinical trials of several aspects of HIV/AIDS: drugs, microbicides, vaccines. It’s understandable, then, that AIDS conferences would concern themselves with these matters, for instance at the XVIth International AIDS Conference in Toronto, August 2006:
Science Track C: Epidemiology, Prevention and Prevention Research report by Dr. Quarraisha Abdool Karim
This session examined ethical issues in clinical research for HIV prevention in three ways – 1) through case study descriptions of the experiences around the abandoned/cancelled PEP trials [TUAE0301, TUAE0303, TUAE0305], 2) a philosophical/ethics-based analysis of clinical HIV prevention research [TUAE0302], and 3) a description of a study on a particular aspect of clinical trials, informed consent [TUAE0304]. The main theme emerging from the case studies and ethical analysis was a recommendation to further develop systematic approaches to build community involvement/consultation, and community long-term benefits from clinical trial participation so that trials will be accepted and promoted. While it was concluded that provision of long-term treatment to those who seroconvert during a study was not morally necessary, it was felt to be morally praiseworthy and politically necessary. As well, it was felt that power dynamics between community members and researchers needed to be addressed through mechanisms such as research literacy for the HIV advocates in the community. The study on informed consent concluded that the measure of participant understanding of aspects of trial participation was largely influenced by measurement instruments – with closed-ended response formats (checklists, self-report) yielding higher comprehension scores than open-ended methods (vignettes, narratives). In discussion, it was suggested that whatever the measurement method, trial participants consistently show fairly low levels of understanding of study processes and impacts, and that informed consent should not be relied upon as the protection of participants, but rather an emphasis should be placed on other ethical study requirements, such as a balance of harms and benefits” [emphases added].
After a lifetime spent in academe, I’m rather sensitive to nuances that reflect some of its less attractive aspects: theorizing in a vacuum totally removed from human experience; biased views on what various types of “literacy” mean; periodic re-discovery of the obvious. In the above:
“Moral necessity”: No matter what philosophers may “conclude”, the situation with clinical trials is quite plain. Without the trials, the researchers cannot pursue their research and the drug companies cannot develop their products. Therefore the human beings who agree to take risks on behalf of the researchers and the industries should be compensated fully. In the usual case of indigent folk, that ought to mean lifetime health care and nourishment, whose costs in the pertinent places are trivial in comparison to the monetary benefits reaped by the drug companies.
“Research literacy”: Perhaps it’s a paranoid interpretation, but I read this to mean brainwashing activist groups about the absolute necessity of clinical trials.
“Informed consent”: Even in “developed” countries it’s absurd to imagine that lay people can exercise genuinely good judgment about the experiments or treatments being suggested to them. That’s why there exist institutional boards that are supposed to review proposed experiments involving human subjects. It’s the individuals who serve on those boards who need education on matters of research literacy and ethics.
“KC 1: Accelerating research to end the HIV/AIDS epidemic report by Stephanie Nixon
TUAE03 – Ethical Issues in Clinical Trials: Tenofovir and Beyond
This session explored various legal and ethical dimensions of prevention trials.
Anna Forbes, from the Global Campaign for Microbicides, described her organization’s efforts to ensure future access to microbicides. She reflected on the failure of the recent tenofovir trials and identified the absence of promise to ensure ARVs for participants who seroconvert during the trial as the “deal-breaker”.
An audience member raised the issue of undue inducement if the only access to quality care and treatment in a community is through participation in a trial. Forbes proposed that this difficult decision ultimately needs to be answered by the community where the candidate is being tested so that they may determine what represents an inducement that is undue.
Charles Weijer, from the University of Western Ontario, Canada, provided an ethical analysis of obligations to provide treatment in the context of HIV prevention trials in developing countries. He rejected the notion that there is a moral obligation based on the principle of reciprocity to provide treatment to seroconverters because of their unique role in proving the efficacy of, for instance, an HIV vaccine. He proposed instead that all participants play an equally important role. Instead of a moral obligation, Weijer proposed that a “moral negotiation” is required based on the ethical principle of respect for communities. Within this framework, communities would contribute to trial design, influence study results, and share in the study benefits. He argued that because health priorities and values vary among communities, the idea of a predetermined obligation to communities does not respect their unique perspectives. Counter views were raised by audience members regarding the fact that negotiations between researchers and communities will not take place on a level playing field, and that there may still be benefit to having a bare minimum set of obligations from which communities can begin the negotiations. . . .
New ideas for accelerating research to end the epidemic:
. . . .
Charles Weijer, University of Ontario, talked of these guidelines not being a moral obligation but a moral negotiation between communities and the researcher and sponsor. He said “To impose a pre-determined benefits package seems paternalistic.” He argued that communities were in the best place to decide what benefits were most appropriate in their setting [emphases added].”
Weijer’s appointments at the University of Western Ontario are listed in “Epidemiol & Biostats”, Medicine, & Philosophy. Whether or not other philosophers or moralists would agree that there is no “moral obligation based on the principle of reciprocity”, certainly there would not be universal agreement over whether the principle of reciprocity should be the infallible guide to what’s proper in human affairs; this is what I call a (moral) “vacuum totally removed from human experience”. Similarly, the argument that community values should be respected and paternalism eschewed is beside the point in these matters. The whole business of HIV/AIDS is paternalism writ large: communities are not asked whether they prefer food to antiretroviral drugs, they are not asked whether they believe that the deaths their communities experience are from this new scourge or from their traditional burdens of tropical diseases. Indeed, when the leader of such a community, President Mbeki, sought to reach an independent judgment on the matter, a huge apparatus of international paternalism swung into action to oppose him. We respect community values only when they fit with our own wishes: for example, since participants in clinical trials are supposed to be offered no less than the normal standard of care in their communities, First-World industries rush to carry out their clinical trials in places where the normal availability of health care is low or non-existent — note the very valid issue of “undue inducement” raised above.
It strikes me as far worse than disingenuous, it’s exceedingly immoral to enlist academic, theoretical, arguments in the attempt to make it appear that the practices that seem standard in so many clinical trials in Third-World countries are moral or ethical — moral or ethical in the way most human beings understand what those concepts mean.
This entry was posted on 2009/02/02 at 10:17 am and is filed under antiretroviral drugs, clinical trials, experts, prejudice. Tagged: abandoned tenofovir trials, Anna Forbes, Charles Weijer, ethics of clinical research, informed consent, moral obligations of drug companies, moral obligations of researchers, Quarraisha Abdool Karim, research literacy. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.