MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:

Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.

Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.

In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.

The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.

END OF QUOTE

Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:

A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.

“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”

A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”

Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.

According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.

And what should we conclude from all this?

I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.

10 Responses to Data fabrication in China is an ‘open secret’

  • It is very good news that this has been published by Chinese researchers and as you mentioned belief based medicines always gives positive results so why bother testing it. It is just a pity that these “positive results” generated in China is also publicly being used to convince potential users (and politicians, regulators etc) of the efficacy and safety of TCM in countries such as Australia.

    I’ve always asked the question; why didn’t they (the national institute of complementary medicine) reproduce any of these wonderful results generated in China over the last 15-20 odd years since their inception? If they reproduced/confirmed any of it, there would not have been much of an debate regarding that specific TCM. But there is just nothing, no convincing results whatsoever. And why do people still die in China, of different medical conditions, if they use these wonderful and effective TCM’s in time?

    But who cares, it is belief based medicine where you just need to belief and then it will magically work – and that is good enough for my former university.

  • It cannot speak about Chinese reports in scientific medicine, but only about traditional Chinese medicine (TCM).

    As to TCM, it is true that 90 percent of the reviews in China are scientifically rubbish. It ist not true, however, that they are “fabricated”. The problem is that nearly none of the Chinese TCM “researchers” has the courage to do really an OPEN research, which of course should include the option that some TCM methods or principles might prove wrong or obsolete. The aim is always AFFIRMATIVE – and if the findings should be different, they will not be published.

    10 years ago, a certain Zhang Gongyao of Changsha, Southern China, published an essay demanding TCM to be abolished. Very quickly, this became a nationwide issue, with tens of thousands agreeing, and as many protesting, so that the government had to declare they would support TCM forever. This discussion proved that the survival of TCM even in China is far from certain. That is the reason why China’s TCM practitioners, teachers, professors, and book authors have always been cowardly defensive, since Western medicine started to conquer China’s intellectuals after 1820. This cowardly attitude makes it impossible to do any calm and open research about which aspects of TCM are really useful and evidence-based, and which ones are not. And this is the real problem of TCM, not so much data being “fabricated” on purpose.

    Dr. med. Hanjo Lehmann
    Deutsches Institut für TCM
    Cranachstr. 1, D-12157 Berlin
    Tel. 0049-175-6449006
    Mail: Lehmann@TCM.de

    • this is also the impression I got through working with many Chinese collaborators and which I expressed in the 1st post cited above. but it has to be said: whether wilful dishonest fabrication or fabrication by ‘honest’ bias, the result is the same.

  • BW alerted me to this most revealing post from a decade ago:
    http://www.bjreview.cn/EN/06-46-e/china-1.htm

  • Although I appreciate that this blog is specifically designed to debunk – sorry, ‘discuss’ – CAM, it’s important not to forget that ‘evidence based’ conventional medicine has a long way to go too. For example, here’s an excerpt from an illuminating article in The Journal of Evaluation in Clinical Practice:

    ‘Simply put, industry-sponsored evidence is incomplete and biased. Most intervention studies are industry sponsored. This means that the overall evidence about many interventions is incomplete and biased. As a result patients may be given less effective, harmful or more expensive treatments.’

    http://onlinelibrary.wiley.com/doi/10.1111/jep.12147/full

    • “… ‘evidence based’ conventional medicine has a long way to go too…” TU QUOQUE!
      how does that excuse/explain or belittle the 80% from China?

      • It doesn’t. But by highlighting the inherent problems with EBM in general, the overall picture is fleshed out. Your focus is narrow, which is your prerogative, but I think it’s important to widen the aperture a little for casual passers-by with an open mind.

  • It may be telling that the Chinese language has for centuries literally been devoid of a term for ethics or ethical. Add the quota system of the communist government since Mao that punished government-funded factories and institutions for failing to meet them and you have a sure-fire recipe for a culture of corruption. And when it comes to studies in China on herbal medicines, I’ve seen more junk science that you can find in the Chinese naval academy.

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