We’ve shared articles on “predatory online open-access” journals (at least 15,000 of them having popped up in the past 6-8 years) and recently fake research reagents being sold to scientists. Here [see attached article] is yet another form of fraud and corruption in science: this time it has to do with fake data in drug trials, which of course is easily likely to cause death in some patients taking such drugs that have not been scientifically carefully studied for serious adverse effects as well as efficacy. Now –– those who submit faked clinical-trial data might go to jail — and in extreme circumstances, be executed — under a new interpretation of China’s criminal code, that was announced just last month.
The policy shift is one of a handful of measures that China is implementing both to speed up its notoriously slow drug-approval process and to keep dangerous and ineffective drugs off the market. This move “is the strongest signal yet, to all the drug developers, clinical-trial managers, principal investigators, and physicians –– that China is now very serious about clinical data”, says Dan Zhang, executive chairman of Beijing-based Fountain Medical Development, which helps companies to carry out clinical trials and itself stands to be held accountable by the policy change.
A hint of the depth of the problem came after the China Food and Drug Administration (CFDA) in 2o15 ordered companies to re-evaluate “the authenticity, integrity and compliance of clinical trial data” in pending applications for new drugs. The agency told them that, if CFDA examiners later found violations, the companies would not (ever again) be able to submit other drugs for approval. More than 80% of the applications were voluntarily withdrawn, according to CFDA documents. One-quarter of the remainder was subsequently rejected because of problems with authenticity.
This new policy will broaden current laws to cover submissions of clinical-trial data. Manufacturing and selling counterfeit versions of drugs had already been a crime, but submission of fake data in the approval process was previously “unregulated territory.”
Nature 18 May 2o17; 545: 275