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.'
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.'
Labels: China, clinical trials, ethics, fabrication
posted by Stuart Rennie at 4:08 PM
12 comments
