Fake Chinese Data In Drug Trials: Let’s Hope It’s Just In China

By

Leonard Zwelling

         A concerned reader sent me this report from Doximity:

http://news.doximity.com/entries/4946944?authenticated=false

         It describes widespread fraud and data fabrication in the Chinese system of drug approval and regulation as it pertains to Western medicines. The malfeasance may be even worse in the oversight of traditional Chinese forms of therapy.

         The repercussions of this are not small. It says a great deal about the mindset of those doing clinical research in China and something that I have observed for quite some time since I was a Vice President at Anderson and again as the Chair of the Institutional Animal Care and Use Committee (IACUC) during my final years as a faculty member. Many people (not all) from foreign countries have very different views of science, research with vertebrate animals, and human subjects research than we tend to take for granted in the United States.

         Many other cultures put an emphasis on pleasing the boss above all else. This tends to create an environment where the workers (grad students, fellows) generate data that fit the lab supervisor’s latest theory, whether or not it is correct. I understand that this is a harsh judgment, but I have published a paper that looks at this with some of my MD Anderson colleagues and found about half of those surveyed at Anderson had trouble reproducing data in the medical literature or acquired by others:

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0063221

         Almost every case of misconduct reported to the IACUC during my three-year stint as chair involved those from other countries doing research at MD Anderson in a manner inconsistent with the rules governing animal investigation. It was not because these were necessarily bad people or folks who went out of their way to break rules. They simply had a very different view of human and animal research and research misconduct regulations or the relationship of those regulations to reality or to surviving in a fiercely competitive academic environment.

         Those who advocate fewer regulations and more relaxed standards should take note of this report. The price of freedom is responsibility and if the latter is ignored not only freedom, but safety can be sacrificed.

         No one likes rules. I get it. But many of those rules were derived in response to harmful actions of some humans on others and that includes the rules governing human subjects research. If these rules are ignored and those governing other research conduct are likewise flouted, the resulting chaos in science and medicine will cost lives.

         Clinical research is not clinical care. It is a highly regulated endeavor and is so for a reason. That’s true of animal-based research as well. They are too important to be left to the individual to do the right thing.

         In many ways it’s a lot like the difference between Judaism and Christianity.

         Judaism is a religion of law—613 commandments. Do them. This is not a discussion between God and man. These are the instructions for leading a good life. Just do it.

         Christianity seems far more inwardly focused. It is faith that guides action and doing good shall be guided by the relationship between the individual and that faith. Fortunately, when that breaks down there’s forgiveness.

         In my years overseeing clinical research at Anderson, there was rarely a week that went by when I didn’t have to take the Jewish approach (easy for me). No, you can’t do that because the rules say otherwise, but we will try to figure out a way for you to get what you want within the rules. Fortunately, I also had to rely on the Christian approach fairly regularly and forgive regulatory sins through the power of confession and occasionally penance. Bodies like the IRB and the IACUC helped.

         These rules we humans make are purposeful. They are usually neither random nor arbitrary. In China today we can get a glimpse of the world without research regulatory oversight. Make no mistake about it. People will die because the system has broken down. Entropy rules. Either you pump energy in the form of regulation into the realm of human research regulation or the system will degenerate to chaos. That seems to have happened in China. Please not here.

Leonard Zwelling