The Chinese Way to Manage Stem-Cell Research

The Economist reports that Chinese researchers are doing world-class stem-cell research, but they identify a problem - they don't think that Chinese medical research is regulated tightly enough.  Their article opens:

In the field of stem cells, China is showing that it can do world-class science. It is a shame, then, that so many fraudsters operate and that officialdom turns a blind eye.

Their tone of viewing with alarm continues into the body of the report:

A Confucian rejection of the idea that embryos are in any meaningful sense human beings (a view shared by many Koreans), together with the possibility of stealing a march on the diffident West, has stimulated a lot of research into stem cells in China. And not only research. Chinese clinics have moved with what many foreign scientists regard as indecent haste into the offering of therapies. Patients from around the world fly in for the treatment of conditions ranging from autism to spinal-cord injury-treatments that are rarely based on science that would pass muster with the authorities in most rich countries, and are often outright frauds.

The point of studying stem cells is that a stem cell can turn into any one of the body's hundreds of different cell types.  If you break a nerve connecting your brain to your hand, for example, you'll be paralyzed unless the nerve grows back.  Human nerves seldom do that, but stem cells offer the potential to grow new nerve cells to give you back the use of your hand.

Stem cells offer so much promise that they're being studied all over the world.  Chinese researchers are world class, but the Economist is afraid that Chinese entrepreneurs are selling unproven cures.

China's health ministry has, however, turned a blind eye to the unauthorised stem-cell therapies offered by hundreds of hospitals under its jurisdiction. One company in particular, Beike Biotechnology in Shenzhen, Guangdong province, is notorious for its internet claims and marketing efforts in countries around the world. It claims to supply stem cells to a network of more than two dozen hospitals in China and one in Thailand for treating myriad conditions at a cost of about $20,000 a pop.

Beike says it has treated over 6,000 patients, but it has yet to publish any papers in internationally recognised, peer-reviewed journals. Yet it seems to have powerful friends. It claims to have received funding from the China State National Fund and Shenzhen municipality. It also claims to have members of the Chinese Academy of Sciences and Chinese Academy of Engineering on its scientific advisory board. And Xinhua, China's state press agency, calls Beike "a global leader in stem-cell research and treatment through evidence-based medicine".  [emphasis added]

First of all, what's so special about "peer reviewed" journals?  The emails leaked during Climategate showed that the peer review process has been manipulated when "respected" scientists sought to suppress competing studies which indicated that global warming wasn't as scary as they wanted taxpayers to believe.  Given what we now know about "peer review," we can sympathize with Chinese reluctance to get involved.

Furthermore, why should the Chinese give away hard-won, commercially-valuable knowledge?  Researchers in the US are not supposed to profit from federally-funded research, at least not much.  They're supposed to get their rewards from being published and honored while leaving the profits to their universities and to drug merchants.  Can anyone blame Chinese researchers for not wanting to be exploited like unpaid college football stars?

Finally, how does one test a new medical treatment?  One tries it.  If you're in the United States, you have to genuflect to the FDA and jump through myriad hoops to get permission to test a new therapy, and then you have to pay all the treatment costs yourself until it's approved.  Thus, only obscenely well-funded organizations can afford to carry out medical research - it costs about a billion dollars to get any new treatment through the approval process.

The Chinese approach, while perhaps a bit rough on early-adopters who line up to pay to have new therapies tested on them, will almost certainly lead to faster progress than the hidebound FDA approach.  Not only are there far fewer regulatory hurdles to testing a new treatment, you can ask the patients to pay for your tests!

That's why a promising new cancer therapy is being tested in China rather than in the United States.  It's so out-of-the-box that there's no way to get the FDA to even consider approving a trial.  Since it would be illegal to test it in the US and the Chinese were receptive, it was a no-brainer to move the research offshore.

The Chinese approach may lead to more patient deaths as new therapies are tested too early, but it will probably save lives overall as workable treatments are found and debugged faster.

On the whole, we disagree with the Economist.  As long as full disclosure of the risks is made to the patients so they can give their informed consent, we believe that the Chinese approach will save more lives due to treatments being tested faster than it costs as dangerous therapies are tried too soon.  Only time will tell.