This story has been making the rounds the last few days, and it’s interesting on several levels. A report in the Chinese newspaper Economic Information Daily says that the Chinese SFDA (State Food and Drug Administration) has been conducting a review of Chinese clinical trial practices, and after reviewing 1,622 trials has found that most of them are seriously flawed. And by “seriously flawed”, they mean “largely faked”. The story says that “More than 80 percent of applications for mass production of new drugs have been canceled in the light of the findings, with officials warning that further evidence malpractice could still emerge in the scandal.”
It’s important to note that these are (mostly? completely?) trials for the internal Chinese generic market that they’re talking about, combinations of existing drugs:
Healthcare professional Luo Liang told RFA that the domestic 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,” Luo said.
“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.”
Unfortunately, that seems to be pretty accurate. People have been wondering for quite a while when China would come up with its own pharma R&D powerhouse, but so far (at least as far as I can see) this hasn’t happened. What does seem to have happened is the proliferation of people who are looking to turn a quick yuan by banging out “trials” of cheaply made drugs discovered somewhere else. And as many stories have shown over the years, the pharma sector is not the only one in China with this attitude.
It’s interesting that the Chinese government is putting this story out, though – I have to assume that any major story appearing in a Chinese newspaper has been approved by one government ministry or another. It’s embarrassing to make such information public, and the government likes that even less than in many other countries, so they must figure that handling the problem in this manner is worth it. Perhaps to put a scare into some of the generic drug folks? We’ll see if there’s a sequel to all this (arrests, etc.)