A quality control survey of clinical trials in China has revealed gross misconduct in how the data for these trials were handled. The investigation alleges that more than 80 percent of data in these clinical trials were manipulated, doctored, and outright fabricated.
Led by the Chinese State Food and Drug Administration (SFDA), the investigation reviewed data from over 1,600 clinical trials. These involved trials set to receive regulator approval for mass production. The expose was covered by the Economic Information Daily newspaper.
In the expose, SFDA found that more than 80 percent of the data showed scientific dishonesty and corruption at nearly every level. This included deletion of records for adverse events associated with treatments, and massaging data into desired outcomes.
More egregiously, the investigation found that the results of some clinical trials were concocted even before the study began.
This is a "breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents and medical staff," the State Food and Drug Administration (SFDA) said in its report, highlighting deliberate deceit at all levels. Even third party agencies such as contract research organizations whose jobs are to manage and inspect clinical trial facilities were found to be fraudulent and cited as “accomplices in data fabrication due to cutthroat competition and economic motivation.”
Clinical data fabrication is apparently a systemic problem that’s “an open secret even before the inspection,” said an unnamed source in the newspaper.
The problem may boil down to competition. And in a market where every pharmaceutical company is trying to earn approval to mass market a Western drug for profit, competition seems to have sabotaged scientific and ethical integrity.
"The domestic market for Western pharmaceuticals in China is either confined to very straightforward generic products that have been around for a long time ... or revolves around joint-venture pharmaceutical manufacture with foreign companies," said Luo Liang, a healthcare professional to Radio Free Asia.
"Either that, or Chinese pharmaceutical factories get hold of the formula for certain drugs whose patents have expired," said Luo Liang. "There are no new drugs in development in the same way that there are overseas."
To Liang and others, the degree of fraud in the Chinese clinical trials is wholly unsurprising and could potentially point to other aspects of Chinese science. "It's not just the medicines," said Mai Ke, a rights activist in Guangdon. "In China, everything is fake, and if there's a profit in pharmaceuticals, then someone's going to fake them too."
But perhaps international scrutiny of this problem will prompt swift reforms in how clinical trials will be conducted and inspected in the future in China.
Additional sources:
Radio Free Asia,
Science Alert
