Clinical trial data is being manipulated on a large scale, according to an extensive review of trials for new pharmaceuticals in China.
As reported in the Economic Information Daily newspaper earlier in September, the Chinese State Food and Drug Administration performed a one-year review of 1,622 clinical trials of pharmaceutical drugs awaiting approval for entering the market.
They concluded that more than 80 per cent of the clinical trial data was “fabricated,” incomplete, untraceable or failed to meet requirements for analysis. According to the report, some pharmaceutical companies have allegedly tampered with data that did not match the expectations for the drug, or have been hiding or deleting records of unwanted side effects.
“More than 80 per cent of applications for mass production of new drugs have been cancelled in the light of the findings, with officials warning that further evidence [of] malpractice could still emerge in the scandal,” reportsRadio Free Asia (RFA).
These applications were all for Western-style drugs, rather than traditional medicine. Experts interviewed by RFA noted that the issue in Chinese pharmaceuticals manufacturing lies not with a lack of rigorous standards for clinical trials, but rather with their implementation.
“I don’t think that the 80 per cent figure is overstated,” healthcare professional Luo Liang told RFA. “If you compare Western pharmaceuticals manufactured overseas with those manufactured in China, there is a huge difference in the ingredients; the quality of the China-made drugs is appalling.”
Some of the ‘new’ drugs in the applications for mass manufacturing were found to be combinations of drugs already on the market, with clinical trial outcomes written before the data was gathered.
The clinical trials scandal in China, while specific to the national market and regulatory framework, is also a reminder of problems inherent in the system of clinical trials across the pharmaceutical industry at large.
For example, to highlight the fact that companies and researchers routinely withhold the results of clinical trials, UK evidence-based medicine activist Dr Ben Goldacre started an AllTrials campaign in 2013, demanding that planned trials are registered before starting them to ensure transparency and accountability of results.
“There’s a real problem in the way that clinical trials report their results. You can measure the outcome of your trial in hundreds of different ways,” Goldacre told Cosmos magazine earlier this year.
“That’s why traditionally we ask people at the beginning of a clinical trial to specify exactly what they are going to measure as the success criteria, and exactly how they are going to measure it.”