Chairman Mao probably wouldn’t have approved of selling investigational drugs. His Cultural Revolution was meant to turn things upside down, and in the process purge Chinese society from dark, greedy capitalistic forces. Although China still is run by a centralized communist party, in some departments, it can even give American capitalism a run for its money.
With this, we report David Cyranoski of Nature writes some elite hospitals in China will soon be able to peddle experimental (e.g. non regulatory agency approved) therapies that are used to engineer a patient’s own cells to treat diseases and disorders. Cyranoski notes that the Chinese government three years ago ceased the sale of experimental cell therapies after the death of a patient who received such a treatment.
Currently in draft policy state, it has received mixed reviews in China. On the one hand it could give patients with terminal illnesses the chance to access potential treatments. On the other hand, if they are not approved, what kind of danger would this open the Chinese population up to? Most countries require regulatory approval for gene therapies. Other countries offer accelerated or special access schemes such as Australia.
In China the government (and industry) seek to “promote innovation and industry in cell therapy, which will eventually benefit patients” reported cancer immunologist Mae Jie, director of the biotherapy centre Beijing Hospital. Nature notes although there it is a step in the right direction, the danger involving cell therapies could be great.
Generally regulators worldwide take their time when it comes to cell therapy treatments for sale. Cyranoski notes the legal ambiguity in the Chinese regulatory world. Apparently, hospitals (especially military hospitals) sold experimental cell therapy treatments at the same time safety and efficacy testing were ongoing. Based on an informal survey by Nature, it is estimated that approximately one million people paid for regulatory unapproved cell therapy treatments “making China one of the world’s largest markets for cancer immunotherapies.”
Now we go from Mao to Money. Apparently in China a student, after viewing an internet (Baidu) advertisement, purchased an investigational cell therapy for rare cancer for $30,000. The treatment didn’t work; the patient died. Nature did report that the government cracked down but even one life lost like that troubles the conscious. So the pendulum has swung from a coin-operated free for all (“hundreds of hospitals were offering these therapies without sufficient training, etc.) to what appear to be more rational, balanced rules. TrialSite News will monitor the commercial distribution of pre-approved, investigational cell therapies in China.Source: Nature