Saturday, October 22, 2016

Bioethics in China: not wild, but not tame either

Here is a way to turn yourself into a hostage of fortune, in bioethics and elsewhere. It is to vigorously defend something against allegedly unfair accusations, while acknowledging you may not know all the relevant information about what you are defending. That position can, should inconvenient truths come to light, transform you into an advocate of the dubious.

Case in point: back in July of this year, Douglas Sipp and Duanqing Pei wrote a comment in Nature entitled Bioethics in China: No Wild East. In it, they defended Chinese research practices (particularly in regard to genomics research involving human embryos) against accusations of being morally cavalier, loosely regulated, and prey to corruption. According to the commentary, Chinese research has been given bad press about its practices that do not match up with regulatory and laboratory reality. Biomedical research, including highly sensitive studies, is being (or well on the road to being) conducted responsibly there, even to the extent that China has some lessons for the rest of the world in this respect. Probably some truth to it, but you know this will not end well.

Earlier this month, China's State Food and Drug Administration (SFDA) disclosed that after examining a year's worth of clinical trial (n = 1622) data, that up to a whopping 80% of said data was fabricated. According to the report, the fabrication in part took the form of deliberately underreporting harmful side effects and adverse events experienced by trial participants in order to gain the necessary safety approvals. The SFDA surmised that the motivation for the fabrication was financial: trying to get drugs to market faster than their competitors.

You could of course say this is a victory for Chinese regulators who at least looked for, found and reported the research fraud (though what penalties will be levied, if any, is unclear). And certainly every country has its own struggles keeping biotechnological advances on the straight and narrow, particularly in the private sector. But it does complicate attempts to defend the ethical climate of research in China against perceived 'bad press.'

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Saturday, May 12, 2012

The ethics of drug addiction research in China

Reports about what goes on in 'drug rehabilitation centers' in China have been dribbling into the media for some time now. Arrest for illegal drug use in China can lead to compulsory treatment (for a minimum of 2 years) at detention centers that, according to a New York Times piece in 2010, function as de facto penal colonies where inmates are fed substandard food and denied basic medical care. The detentions are enforced by police, where the drug user has no opportunity to have a trial, face a judge or raise an appeal. When a drug user leaves detention, the problems do not end there: their having been arrested for drug use is noted on their national identification card, making future employment difficult and leaving them vulnerable to frequent and humiliating searches by police. This is not a rare phenomenon: according to the Joint United Nations Programme on HIV/AIDS (UNAIDS, 2010), half a million people are confined in drug detention centers in China at any given time. Perhaps it would be marginally better if those with drug addictions received effective treatment during thier detention, but the most reports point in the other direction: 'treatment' may come in the form of unpaid labor in chicken farms or shoe factories, or in the form of untested 'therapies' like sandbox play, art, or boxing. The 'treatment' looks like punishment, exploitation, or merely lame.  


Question: would it be ethical to conduct research with drug user detainees in such circumstances? In the abstract, those with substance abuse problems are vulnerable persons in poor health, and it would be good to have research on effective interventions to combat drug addiction. But in practice, it gets complicated. The journal Science recently published an article entitled 'A memory retrieval-extinction system to prevent drug craving and relapse'. The study was conducted at Beijing Ankang and Tiantanghe Drug Rehabilitation Centers, but these are two of the facilities that have raised concerns about human rights violations over the past years. Human Rights Watch has published a Letter to the Editor in Science that raises concerns about research being done within institutions suspected of human rights abuse. Should a new intervention be tested against the local standard of care, where there are serious doubts about the effectiveness of that care? In these circumstances, is voluntary informed consent of participants really possible? Are researchers who conduct research in these facilities complicit in the ill-treatment of drug users at the hands of Chinese authorities? 


The story is made murkier by the involvement of the US National Institute for Drug Abuse (NIDA) in the study. Two of the authors on the study are from the NIDA, who apparently helped with data analysis and the writing of the article. Since they were significant enough contributors to the research to warrant authorship, should the study have also been reviewed under the (rather stringent) US regulations governing prisoner research, and if it did, would it have passed muster? It will be interesting to see how this case evolves as the facts become clearer. 

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