80% of Chinese Pharma Clinical Data “Fabricated” Says Government Report

A recent government investigation by Chinese regulators concluded that more than 80% of pharmaceutical clinical data from Chinese studies is “fabricated.”

What happens to pharma and regulations has often been a harbinger of what is to come with medical devices. The conclusion also helps explain the U.S. FDA’s caution when accepting data from clinical studies performed overseas.

Radio Free Asia (RFA)reported on September 27, 2016 that Chinese regulators looked at data from 1, 622 clinical trial programs of pharmaceutical drugs awaiting regulatory approval for production and marketing. RFA said it based its reporting on an expose in the Economic Information Daily newspaper.

Hiding, Deleting Records

According to a source in agency, the Daily said the Chines government report said that much of the data gathered during clinical trials were 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.

“Open Secret”

The clinical data fabrication was “an open secret even before the inspection, ” the paper quoted an unnamed hospital chief as saying.

The report singled out third party inspection agencies known as contract research organizations, saying they have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”

One healthcare professional, Luo Liang, told RFA that the domestic Chinese pharmaceutical industry struggles to turn a profit under current conditions. “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.”

“Either that, or Chinese pharmaceutical factories get hold of the formula for certain drugs whose patents have expired, ” he said. “There are no new drugs in development in the same way that there are overseas.”

Academic Ethics

Luo continued that academic ethics is also an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data.

“I don’t think that the 80% figure is overstated, ” Luo said. “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.”

There was no mention of clinical trials and data for medical devices. U.S. regulatory consultants we’ve talked to say that Chinese device makers are focusing on manufacturing 510(k) FDA-cleared devices when U.S. patents have expired, primarily for domestic consumption in China—510(k) cleared products, of course, do not require new clinical data.

Most New Applications Cancelled

Because of the findings, more than 80% of applications for mass production of new drugs have reportedly been canceled. Officials warning that further evidence of malpractice could still emerge in the scandal. The report states the cause of the “fabrications” is the result of “breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents and medical staff.”