This Wall Street Journal article (Asia’s High-Tech Boom Is Good for Us, Too, by Nathan Myhrvold and Edward Jung) trots out the party line re: China and intellectual property; strong IP protection makes it safer for inventors and companies to take big risks. Now that China will be harvesting the intellectual fruits of its bumper crop of über-educated individuals, they will see the benefit in protecting intellectual property better, and so they will.

One excerpt:

As an economic strategy, copying makes sense when your main competitive advantage is cheap labor. But the exponential growth of cellular phone networks holds an even more important lesson for Asian economies: If you’re smart, you can skip a few rungs on your way up the value-creation ladder. Many countries around the world never built full land-line phone systems; they jumped straight to cellular.

All over Asia, political and business leaders are thinking about similar shortcuts to a technological economy. There are two basic ingredients: battalions of well-educated and strongly motivated inventors, and a patent system that ensures companies can earn a return on their investments.

…

If everything comes together, the flood of shanzai phones will gradually slow to a trickle, and Chinese companies will themselves start making gadgets worthy of knocking off.

If I had to come up with some word that would summarize the processes of creating “battalions” of capable inventors and instituting an effective patent system, the last word I would use to describe such things is “shortcut.”

And the order of events in that last sentence is incorrect. Chinese companies will not start making pirate-worthy inventions after strong IP enforcement cuts back the amount of pirated goods. Chinese companies will need to start making pirate-worthy inventions before strong IP enforcement will be taken seriously. Copying, up until that point, remains a strong economic strategy.

The article also glosses over the debate surrounding whether there are certain industries that benefit more from intellectual property protection than others (i.e. patents encourage innovation in chemical/pharma, but discourage innovation in software). Maybe China will come up with a more rationally designed system.

The thrust of the article, though, is less about China than it is about America. The writers’ two final points are: America needs to fix up its patent system as well, and what’s good for Asia (larger middle class, a bigger share of the “technology and wealth pie”) is also good for us. The “us” they are referring to meaning American corporations, I assume.

So the New York Times posted an article by David Leonhardt called In China, Uneven Progress in Health. It’s essentially a “they’re doing great but…” China article. This time it was: the economy has been great and all, but success has been distributed unevenly and healthcare has not been improving concomitantly. Well, duh. I’m not sure what the news is here. My theory is that this guy just came back from a China trip and felt like writing this up; he just about says as much in the article. All of his other articles are related to U.S. economics and fiscal policy, nothing China related at all.

In any case, the real point of the article is to set up China as a counterpoint (or a straw man, if we want to be cynical about it) to the United States, which he calls out in the final paragraph (if you can call them that, as I was counting I was struck by how short journalism paragraphs are):

There is, after all, another large country with unimpressive recent gains in life expectancy, even smaller than China’s. That’s right: the United States. Since 1990, we have been passed by Chile, Denmark, Slovenia and South Korea, among others. China is still five years behind us, but it’s gaining.

I was curious to see what the comments on this article thought, and I did a little survey:

There were only 20 comments on the article after two or three hours, and I divided them up into categories. The hash marks count comments and the numbers in parentheses count the total number of “Likes” attached to the comments in each category.

There were a couple off point comments which either reiterated some point in the article or brought up some totally irrelevant fact.

There were relatively few China Bashers, and their comments were mainly a grab bag of “communism blows,” “serves the baby poisoners right,” and then criticism of the one-child policy.

The China apologists were split between people who missed the point of the article slightly, or perfectly rational people explaining China’s mitigating circumstances. The former group seized on the article’s following “omission”:

The article began by saying that the rates of all these other countries (minus the U.S., which I just put there for reference) had increased their life expectancy at a faster rate than China, but the apologists faulted the author for not pointing out that China has nearly a decade on the other third world countries. Of course, those apologists consequently ignore the fact that the author also notes that some countries which started with higher life expectancies than China also improved at faster rates, see below. The latter group of apologists simply brought up points about population size and the like. Nothing earth-shattering.

(Isn’t google cool? That’s the World Bank data visualized.)

Finally, the self-deprecators, in the great majority, certainly got the point that was being made. It’s too bad it had to be made at China’s expense, but they do focus on criticizing domestic policy at least. But that’s not what China Bio Law is about so I don’t feel any obligation to go into it.

One thing I did particularly like about the article was the author’s little historical aside into the “Mortality Revolution,” which basically discussed how economic growth following the Industrial Revolution did not bring immediate health benefits along with it. I’ve put the book on this on my reading list.

Oh, and I suppose here’s the section that was most relevant to this blog; there’s nothing new and there’s already plenty of material out there on this stuff:

Finally, there is the medical system itself. The dismantling of state-run industrial companies over the last two decades has ended the cradle-to-grave benefits system known as the iron rice bowl. In its place was a market-based medical system many Chinese could not afford. Even in emergencies, people sometimes had to bring cash to the hospital to get treatment.

Early last year, the Chinese government began expanding health insurance coverage, with the goal of making it universal by 2020. The initial signs look pretty good. The World Bank does not have data past 2008, but numbers published by the C.I.A. suggest that life expectancy has risen in the last two years. In my travels, I visited a simple, clean clinic in rural northern China that seemed to be providing the kind of basic care that could make a huge difference.

As I was browsing the web I came across this Forbes healthcare blog article, entitled “Could China Steal America’s Biotech Crown?” and written by Matthew Herper.

The article itself is a good read, and it touches on not just U.S.-China competition, but also on globalization, a subject near and dear to my heart. Though I’ve been doing a lot of thinking about the globalization of intellectual property law, especially patent law, and China’s up and coming heavyweight influence in international IP regimes, I have to admit I really hadn’t thought about their potential to influence pharma and medical device regulatory standards. I’ve definitely thought about Chinese pharma regulations in the context of stem cell regulation and how China’s own differ from the rest of the world, but for some reason I never connected that with the Chinese system’s potential for legal export.

The blog post references a few soundbites and musings from the CEO of a pharmaceutical service company, Quintiles Transnational (website|wiki), which does a lot of research outsourcing work and is super hot on China. He gives the standard soundbites–how China’s getting more important, why regulation will hurt American industry–but then he gives the bottom line:

This could put Asian regulators in a position to start defining standards for the world, just as the FDA once did. And it could result in the drug industry taking an Asia-centric bent, Gillings says.

This is definitely something I’ll be researching a little bit more. What I wonder is how inching down from current regulatory standards will be received by voters. Granted, it’s nowhere near, say, trying to strip people of entitlements like Social Security or Medicare, but I think it’s also slightly more of a touchy subject than other types of market-friendly relaxations. The public tends to get slightly more emotional about being peddled bad medication with disastrous side effects. Think Vioxx and the related media attention and litigation. But let’s be honest, the real issue isn’t about voters at all, it’s about how quickly corporate-backed politicians and media would steamroll any public outcry interested parties try to throw up.

There was also a worth-reading comment on the post, made by a Duke University Research Analyst, Patrick Herron. Aside from mentioning that the U.S. and China have had much success because of “bi-national research collaborations and investments, he also lists a number of “critical short-comings”:

Their pharma growth seems dependent upon a massive and opaque real estate bubble; China is short on big success stories and blockbuster drugs; China seems in comparison to other countries intolerant of innovation risk and failure even if their innovation policy anticipates it structurally; and China’s own SFDA depends upon US FDA approvals.

A first consideration is whether China will do a regulatory about face once they end up with “big success stories and blockbuster drugs.”  Sure, they have a nice domestic market whose sick people are getting richer by the day, but China’s probably intent on looking far beyond its own borders. They might play loose and fast while they play catch up, but they can’t avoid countervailing pressures that will follow economic development, such as a populace that starts to care more about health security once their economic security is taken care of. And unless all the big pharma customers decide to lower their own regulatory standards, I’m not sure how this is going lax rules in China are going to propagate through the work. Provided that the purchasing power is there, the territory that sets the bar higher wields mighty influence (e.g. California and environmental regulations).

Finally, Mr. Herron’s very last statement got me wondering about what sorts of inter-agency work is going on, and what those requirements are. This is another feature of globalization, naturally, cross-talk between niche administrative creating international standards among themselves. I’ll write about more about SFDA and USFDA links in the next post.

Here’s a conservation-related bit of news.  Although I don’t think China Bio Law will touch on environmental issues very much, conservation issues still seem to fit squarely within the scope of the site’s subject matter.  So I’ll throw in a post on it every once in a while.

The WWF has released an article describing a statement issued by the World Federation of Chinese Medicine Societies (WFCMS) in Beijing on the their disavowal of the use of tiger-based ingredients. This statement was issued in time for the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) meeting in Doha, which will continue until March 25.

However, I think the WWF article makes it seem like the WFCMS was only really promoting this out of concern for China’s international image.  For instance, they quote the deputy secretary of the WFCMS:

“We will ask our members not to use endangered wildlife in traditional Chinese medicine, and reduce the misunderstanding and bias of the international community,” said the WFCMS’ Huang Jianyin. “The traditional Chinese medicine industry should look for substitutes and research on economical and effective substitutes for tiger products, which will improve the international image and status of traditional Chinese medicine and promote TCM in the world.” (my emphasis)

That makes it seem like conservation of the tiger as a cause in itself is a secondary issue to not bringing down international censure.  The official statement (available at the WWF’s website, but only in Chinese), however, is much broader than that sentiment. For instance, it states:

In traditional Chinese culture, the tiger is a symbol of bravery and power, and it has powerful totemic and symbolic meaning.  The WFCMS is China’s international academic organization for Traditional Chinese Medicine (TCM), and while it pays attention to the development of TCM and to the transmission of  the culture of TCM, it also highly values and concerns itself with the preservation of tigers and other endangered plants and animals.  In accordance with the principle of man and nature developing in harmony, the WFCMS  wants to make a proper and positive contribution to the protection of tigers. (my translation)

However, some tension is amusingly evident in a following paragraph, where they try and distance themselves from the idea that tiger products are across the board illegitimate.  They decry how some individuals and organizations have been misinterpreting TCM principles and peddling tiger wares in order to make a quick buck.  However, they make sure to point out that “historical documents and records” and “thousands of years of medical practice” have confirmed that tiger bones are effective in:

• 追风健骨: Can’t find a direct English translation, literally “chasing wind, strengthening bones.”  But googling descriptions of its functionality gets me: promoting blood circulation by “removing blood stasis,” “expelling wind” and clearing away colds, relaxing muscles and strengthening the bones, alleviating pain, curing gout, joint malformation, repeated spasms of local pain, sciatica, lumbar muscle strain, hypertrophic spinal column inflammation, and rheumatism (granted, some of this may not be the official line);
• 定痛辟邪: again, can’t find a direct English translation, but as a type of analgesic;
• 治风痹: treating wandering arthritis (this term doesn’t seem to have a medical analogue outside of homeopathy circles);
• 拘挛疼痛: treating soreness from muscle constriction; and
• 惊悸癫痫: treating a certain type of epilepsy.

Now, I’m open to the idea that there may be legitimate medicinal uses for tiger bones, provided there was some unique aspect of tiger bone physiology.  However, thousands of years of unscientific practice and historical documents do not strike me as being the most reliable source of evidence for those uses.

I was originally just going to comment on the WFCMS statement, but there are a number of other interesting things going on here.

CITES has prohibited the international trade of tigers and tiger parts since its inception, back in 1975.  However, the convention does not supersede domestic law, and it is up to individual nations to pass domestic law regarding trade bans.  China became a member of CITES back in 1981, but did not ban the domestic tiger trade until 1993, under international pressure and/or nearly complete elimination of its wild tiger population.

Prior to the domestic ban, a number of tiger farms were set up in order to harvest the tigers for trade, and after the ban they ended up becoming tiger parks, where the tigers put on shows for tourists.  There are currently 20 of these safari parks left in China (NYT), and while sale of tiger parts is illegal, alcohol steeped in tiger bone is still a hot commodity.

Currently, conservationists generally want these tiger farms closed, tiger farm owners want the government to loosen trade restrictions in order to sell their backlog of frozen tiger carcasses, a number of economists believe that legalizing the tiger trade would be the best bet for the survival of the species, and other experts claim such an idea would inevitably lead to more wild poaching that would eliminate the wild tiger population, and tiger farms would probably be quite happy with that prospect.

Given how popular tiger-derived medicines are in China, I’d say a better bet would be to reduce the demand, and reduce it fast.  Not an easy thing, given the deep-seated traditions and the economic forces at play here.  But the role of advertising in reshaping people’s attitudes towards the world and towards certain products can be fairly powerful.  Scarily so, sometimes.  (See, especially, this 2008 article).  Linking the use of tiger products with people’s disgust reactions would be great, but China’s television is so sanitized that I wonder if it could be done well.

Sources:

• CITES website
• Entry on Tiger Trade
• NYT
• WSJ
• WSJ
• The Hindu
• UPI Asia

Excuse the new site.  Working on modifying a theme and getting everything up to date.

I apologize for the hiatus, but law school has been a little overwhelming over the past month.  However, two recent visitors to my law school did bring up some interesting tidbits about Chinese patent law that are very relevant to China Bio Law.

The first speaker was Scott Brown, an ’85 IU-B Law alum who is currently working at the Novartis Institutes for Biomedical Research as General Counsel and Global Head of Patents.  While he was here he stopped by my Patent Prosecution class and gave a talk about his experience as an in-house practitioner.  In passing he mentioned a feature of Chinese drafting requirements that has been changing how they draft patents at NIBR.  He was primarily referring to the State Intellectual Property Office’s (SIPO) low tolerance for a lack of specificity in a patent’s disclosure, especially when it comes to pharmaceutical compounds. For instance, in a June 2008 article Amy Feng describes local practice in allowable amendment content (and another pertinent article is available here):

It has been provided by the Chinese Patent Law that any amendments to the application may not go beyond the scope of the disclosure contained in the initial description and claims. The current Guidelines further interpret “the scope of the disclosure contained in the initial description and claims” to mean “the contents that are literally recited in the initial description and claims, and the contents that can be directly and undoubtedly determined from the initial description and claims.“

In practice, it is normally difficult to establish that the amended contents can be directly and undoubtedly determined from the initial description and claims. As a result, examiners are reluctant to accept the amended contents, if the amended contents are not literally recited in the initial description and claims.” (Emphasis added.)

Given the bio-industry’s inability to avoid Chinese massive and growing market, requiring pharmaceutical companies to disclose more information than they would have otherwise in different jurisdictions could alter their style of drafting in those jurisdictions.  I have yet to look at the new implementation guidelines for last year’s amendments to China’s patent law, so I don’t know if there’s anything that will affect this practice.  Additionally, the take on China’s strict requirements is generally that it’s something of a protectionist measure.  Or if protectionism is not the correct term, then at least what I mean is that the measure increases the likelihood that China gets access to more industry information than would otherwise not be made available elsewhere.  The idea, I assume, is that it will help local companies (well, everyone in the world really) play catch up and/or stay competitive.

The second speaker was Margo Bagley, an IP Law professor at the University of Virginia’s law school, who came to give a talk in my IP Colloquium class.  The topic, invention creation activity boundaries, was not focused on China, but China’s new “genetic resources protection” provisions in its current patent law did play a role in the talk.  The new paragraph in article 5 of China’s Patent Law (English, Chinese) states: “No patent will be granted for an invention based on genetic resources if the access or utilization of the said genetic resources is in violation of any law or administrative regulation.”  (See this article for a thorough comparison of the law as it was amended and the proposed drafts of the amendment.)  Prof. Bagley is interested in this type of bio-protection provision, which has cropped up in the intellectual property regimes of a number of developing countries with extensive genetic resources, in her research on how IP laws restrict the granting or enforcement of patents based on illegal, immoral, or unethical behavior.

What I am more interested in, however, is how China’s position on this issue will affect international intellectual property law in the future.  A recent effort to amend the TRIPS agreement to make bio-protection provisions such as China’s a mandatory component of the treaty failed to gain any traction, and it was only supported by 11 nations.  Both Japan and the United States are opposed to adding these sorts of requirements because they fear they would overburden and de-incentivize patent applicants.  However, given the fact that three of the BRIC nations (Brazil, India, and China) pushed for this idea and given China’s steadily ascending stature in the world of intellectual property, this issue is unlikely to fade away.  China has readily acceded to international IP standards, but these standards were shaped largely by developed nations.  When China has more bargaining capital on hand in future international IP negotiations, new standards will probably give much greater deference to her concerns.

All in all, very exciting stuff.  I think I will be shifting my focus away from stem cell treatment and the regulation of research, because I’m mainly working on other projects this semester.  So expect to see more on China’s attempts to increase its innovation capabilities in the life sciences, and especially much more on patents in the life sciences in China.

On the 18th the NYT published one of its mini-debates, this time on the subject “Will China Achieve Science Supremacy?” The content is right up my alley and of interest to this blog, so I’ll run through the arguments of the six contributors.

Gordon G. Chang wrote, “Hard Sciences Require  Freedom, Too.”  He asserts that China’s one-party state has already smothered creativity in the “soft sciences” (polisci, history, economics, etc.), and that its current policies will do exactly the same in the “hard sciences.”  He boils his argument down into the four following creativity-killers:  the Communist Party’s orthodoxy, Marxist instruction in schools, a flawed educational system, and internet censorship.

I just can’t say I am all that convinced.  While I certainly am no fan of the CCP’s policies in these areas, they simply don’t strike me as effectively precluding technological innovation.

As an example of how the CCP’s orthodoxy stifles genuine scientific advancement he describes the CCP’s policies re: China’s various minorities as an impediment to researchers who want to study the biological aspects of China’s ethnic or racial origins.  This has a kernel truth, but Chang also claims that “wide swaths” of biology become sensitive areas because of such policies.  While I agree that political considerations could potentially interfere with legitimate scientific inquiry, I strongly disagree with his assessment of the extent to which such control occurs.  Would such “selective blindness” in a scientific community affect certain trends in scientific research?  Yes.  Would such “selective blindness” impede innovation across the board?  I’m not so sure.  Science is a lot larger than Chang gives it credit for.

As for the Marxist instruction in schools, he claims such ideological indoctrination results in “distraction from real research and study” and “stifles free thinking across the board.”  Now perhaps I’m wearing rose-colored glasses here, but I think he greatly exaggerates the extent to which the scientific population is affected by required Marxist-Leninist classes.  This might simply be anecdotal, but the vast majority of my Chinese friends and acquaintances who went through the university system thought these classes were ridiculous, boring, and a waste of time (after class, of course, they hop onto their computer, download Prison Break, Desperate Housewives, and 24 and distract themselves from “real research and study”).  And while I don’t doubt that a percentage of the Chinese population may be negatively affected by such classes, but I do doubt that those who are so easily swayed would make for very good scientists in the first place.  I mean, how often do you hear people claim that the U.S. will never be a scientifically innovative country because of the high prevalence of childhood religious instruction, yet another form of ideological indoctrination?  I mean, at least Marxism-Leninism holds science and technology in high esteem.

The last points he makes are better, although not perfect.  China’s educational and scientific environment does have serious shortcomings, and Chinese scientists have been vocal advocates of reform.  They are keenly aware of how damaging incidences and allegations of academic or scientific misconduct are to China’s place in the international scientific community.  As for his internet freedom argument, while I am persuaded by arguments that this will hurt innovation in China’s IT sector, I am less convinced that censorship or internet policy will be as serious an impediment in other areas of science.  I’ve never seen Falungong on the front page of Nature or Science, and most scientific topics are of neutral-importance to the CCP.  Short of completely cutting off access to international sites,  I don’t think there would be a serious impediment to potential innovation.

The next essay, “A Climate for Misconduct,” by Cong Cao, is the standard “what’s wrong with the Chinese scientific establishment” article.  He highlights a number of issues.  First, he discusses how the financial and political advantages attached to greater academic credentials can leads to scientists seizing risky or unethical opportunities to get to the top.  I’ve always thought this was an interesting point, because it either means that giving scientists too much money equals bad science or counterproductive consequences, or simply that  the methods used to vet legitimate advancement are lacking.  Regarding the former, this TED talk is good food for thought, because it claims that psychological experiments have consistently shown that financial incentives for creative work actually reduce productivity.  Perhaps the fact that our scientists aren’t remunerated as well as athletes or movie stars is actually a pillar of American innovation…It is probably not far from the truth to claim that  many scientists wouldn’t do what they do were it not for their love of what they do.

Following that argument, there’s the oft-repeated “too much emphasis on quantity” of publications and the “crushing institutional pressure” placed on scientists by the government.  Cong Cao also alleges that it is nearly impossible to expose wrongful conduct among high-profile scientists, that the institutional processes that are responsible for monitoring scientific misconduct are not implemented properly (I’d like to know if he’s referring to specific institutions/regulations or if he’s speaking generally here), and that there is at least a correlative link between instances of scientific misconduct and the circumstances of China’s heavily commercialized society and corruption-heavy bureaucracy.

John Kao, in “Can Quantity Lead to Quality,” acknowledges that China can have all the patents and publications in the world, but for it to truly have “innovative science” it will need to actively link its scientific and technological abilities to “entrepreneurship, design and social innovation.”

Vivek Wadhwa, in “Many Reasons to Return,” presents some great statistics on how Chinese nationals who trained abroad and have been enticed to return to China  have fared.  Short answer–very, very well.  Great conclusion:

The bottom line is that the U.S. is providing China a huge amount of foreign aid without even realizing it. We’re exporting engines of economic growth and helping them become our long-term competitors.

Jonathan Moreno’s “The Stem Stell Example” focuses a little bit more on what the United States should do to improve its scientific prowess.  He basically says that 1) we should take advantage of our open society, which he believes translates into an ability to foster scientific exchange through personal relationships.  I’m not really sure what he’s getting at in that sentence, but he goes on to say that a better visa system would help, so I’m assuming that by “scientific exchange through personal relationships” he means bringing in top
-flight foreign nationals to do science here in the States.  Then 2) we should also “invest in our patent system to ensure timely and valid awards.”  This is a great sound bite but I have no idea what this means.  Patent reform?  More money to the USPTO?  What?  If I had to guess I’d say that he probably wants to make sure that the way our patent system functions works to foster and not stifle innovation.  Easier said than done.

One odd thing he claims, which I haven’t heard of before, is that on a recent visit to China he was unable to access websites about U.S. research standards, among other innocuous topics.  I would definitely like to know what search terms he was using and what websites he tried to visit before I believe this claim.  In all my time spent lurking on the Sinophile blogosphere, I’ve never heard anything like that.

The final essay, “Strengths From the Top” by Gang Xiao, deals with the factors that will make China’s “Thousand-Person Plan” successful.  This refers to the government’s plan to recruit Chinese scientists and engineers back from abroad using fantastic incentives.  He calls out the main stumbling blocks affecting the returnees: having to deal with the close-knit hierarchy of existing research networks, circumstances in which subjective factors often trump objective evaluation of science, and the lag-time involved in attempting to get resources from local governments and institutions.  He presents the triumvirate of innovative science, the ability to “think independently, form collaboration networks without interference, and distribute and access information freely.”  One final note, he comes out with this funky sentence, “China has the ability to achieve its goals because it has often done so once it determines that these objectives are imperative to its future.”  Talk about tautology.

Most of these people also have China/Science books out, which has added almost 2000 pages to my “to-read-eventually” list…

“It is a paradox. We don’t want to paint the whole country with the same punishment. China is leading-edge in top journals, yet at the same time they have very questionable practices at these stem-cell clinics, which are often not proven therapies,” [Dr. Tim Caulfield, Canada's research chairman in health law and policy] said.

This quote comes from a recent article in the Toronto Sun, entitled “Are we on the brink of a stem-cell breakthrough?”  Don’t let the sensationalist headline and the tabloid-y nature of the newspaper throw you off, the content is actually quite rational.  Much of the info is from an article in the journal Regenerative Medicine.  Not that that source or its publisher is any more reputable; I need to learn more about judging science sources.  Regardless, the research done in that particular article was good as it was based mostly on interviews.

The article kicks off with a  story, putting a human face on the issue.  Basically, a pair of sisters suffered from traumatic spinal cord injury in a car accident, and their father searched far and wide for possible treatments.  He ended up taking them to Shenzhen’s Nanshan People’s Hospital for stem cell treatment.  I’ll do more research on them in a future post.

The treatment is described as five-and-a-half weeks of a weekly injection of “millions of umbilical stem cells” into the fluid of the lower spine.  No more detail then that, I’m afraid, but remember that this was all in concert with “herbal intravenous treatments and acupuncture.”  These Chinese stem cell centers really love this comprehensive treatment stuff.

Needless to say, they were not cured, although they claim that the treatment “boosted [their] immune systems” and they didn’t catch a cold for a whole two years post-treatment.  Hopefully that was worth the $148,000 bill, which was the damage for the treatment, travel and lodging, and two 24/7 personal caregivers.  To be fair, the girls are upbeat about their experience despite the lack of results.  China has a tendency to do that; there are a host of programs that end up being little more than expensive vacations, but there’s something for everyone in China and just the right tinge of the exotic that you enjoy yourself enough to not be disappointed.

The article then uses the Regenerative Medicine report, “Cultivating Regenerative Medicine Innovation in China,” to put the medical tourism side of the Chinese stem cell world in focus.  The RM article itself, however, was about more than just that, it was a general overview of the state of regenerative medicine (i.e. stem cell therapies) in China.  In many ways it’s similar to the editorial I reviewed in my last post, except ten times as long and jam-packed with much more exciting information.  Best of all it features many institutions that I should have some fun looking up in the near future.

I’ll run through the advantages and disadvantages analysis again, and conclude by summing up the bits most relevant to the world of medical tourism.

China’s advantages in the world of regenerative medicine:

• Government support. 

While the article does mention that China has a strong private firm presence in the field of regenerative medicine (compared to other up-and-coming nations like India), it claims that most of the money spent on research in regenerative medicine continues to come from the government.  Over the course of a decade (1996-2007), China’s gross domestic science and technology expenditure increased seven-fold, from USD$5.9 billion to $43.9 billion.  However, those are the figures for all S&T expenditures, and while stem cell, tissue engineering, and gene therapy research get certain funding priorities, they certainly don’t receive a huge proportion of that amount.  I haven’t come across the exact numbers yet; however, the scientists interviewed for the article consistently stated that they felt well-funded by the Ministry of Health and the Ministry of Science and Technology.  On a side note, the Toronto Sun misrepresents the information just described in two ways: first by providing inaccurate numbers for the S&T expenditures, and second by claiming that much of the expenditure goes towards regenerative medicine.  The  former seems to be due to journalistic laziness, the latter to sensationalization.

• Permissive regulations.

The interviewees also believed that China’s permissive stem cell research regulations have helped to propel its biomedicine sector forward.  These regulations permit therapeutic cloning, the use of surplus embryos, and chimera research.  It should be noted, also, that China’s regulatory choices are far from no-holds-barred.  Reproductive cloning, the use of embryos after fourteen days post-fertilization, the implantation of research embryos, and the fusion of human and non-human gametes are all prohibited types of research.  And stem cell regulations require informed consent from patients and review by institutional ethics review boards whenever human embryonic stem cells are being used in research or treatment.  Despite the similarity of these regulations to UK regulations, many in the international community tend to think that Chinese regulations are weak.  To be fair, they may simply be conflating the regulations on the books with the implementation of those regulations, which is in fact fairly weak.

• A strong scientific workforce.

This applies to Chinese science in general as well.  China graduates 400k students in medicine and science every year, and focuses heavily on recruitment of Chinese nationals from abroad.  Providing huge incentives to recall the creme de la creme of the Chinese diaspora is a big part of China’s 11th Five-Year Plan (2006-2010), and the interviewees claimed that  almost 100% of active RM researchers (I’m assuming they’re not referring to lower level personnel in labs) have trained abroad.  The article also describes how low labor costs permit top-level researchers to return to China and set up large labs on the cheap.  I do have a point of dispute about the article’s claim that this creates a favorable educational environment of highly skilled supervisors.  While such researchers may be undoubtedly skilled, the idea that they can effectively impart such training to students in a large lab while managing all the research that’s going on seems a little unlikely.

• A focus on therapeutic application.

This was perhaps my favorite part of the article, because discussions of Chinese international research potential rarely focus on this aspect of China’s scientific goals.  One of the key components of this focus is the sheer amount of money that the Chinese government is investing in hopes of wringing the very last drops of green out of its scientific establishment.  78% of the Chinese government’s R&D funding is reserved for product development and 16.8% is doled out to applied research, which leaves only ~5% or less for basic research.  Part of this may be practical foresight on the part of the government, because the next key component is China’s people.  China’s huge populace is not only a wonderful disease base that China can use in dev
eloping drugs and treatments, they will also be the beneficiaries and consumers of such products.  If China develops its home-grown industry effectively, it will be possible to keep IP and public costs down.  Finally, the most interesting little tidbit in this section is that China has already developed huge primate colonies for the sole purpose of preclinical testing.  I’ll have to look and see what other countries grow their own lab monkeys!

And China’s disadvantages:

• International skepticism of unproven therapies.  

The Toronto Sun quotes Dominique McMahon, one the Regenerative Medicine report’s authors, as saying, “China has not been well-recognized in terms of contribution to research. We think international criticism has been holding them back from moving forward … because of the confusion between the legitimate research being done there with stem-cell clinics providing treatments, which have no clinical evidence.”  This is very unfortunate for China, which is already  constantly under scrutiny by the international scientific community because of periodic reports  of academic fraud and scientific misconduct, such as false resumes, plagiarized work, and falsified data.  There are currently over 200 institutions in China that have already commercialized a number of stem cell treatments.  The purported treatments, I say purported because there is usually no clinical trial evidence or supporting peer-reviewed research publications, include stem cell treatments for “ataxia, Lou Gehrig’s disease, traumatic brain and spinal cord injury, diabetes, Parkinson’s disease, multiple sclerosis, autism, cerebral palsy, stroke, optic nerve hypoplasia and many others.”  China is apparently the 21st century’s Jesus.  Both domestic and international observers are concerned that many of these treatments are without any legitimate effect or, worse, potentially harmful to patients.  And it doesn’t only affect Chinese citizens, because many foreigners are willing to travel to China and pay a pretty penny for these Hail Mary passes.

• Impediments to enforcement.  

As mentioned in the section on permissive regulations, on paper China’s regulatory regime is fairly well fleshed out.   The enforcement problem is not just one of political will, there are also certain institutional weaknesses.  For instance, the regulatory framework for human embryonic stem cells is mostly composed of ministerial guidelines that do not have legal force in themselves.  They can generally only be enforced through funding mechanisms.  Moreover, in China the system of ethical review of clinical treatment relies on the internal review mechanisms of the institutions undertaking such research or application.  Without an external source of review, regulation of government funded clinical applications is sometimes no less tractable a problem than the oversight of financially independent institutions.  Within the last year there have been new attempts at national regulation of stem cell treatments, but I will discuss this in a future post, because their efficacy has yet to be seen.

• Lagging basic research.  

The interviewees were also concerned that there may be excessive focus on clinical application and not enough attention paid to basic stem cell research.  This misguided effort may even stunt China’s ability to produce successful applied research.  This issue is almost purely a government policy issue, because many of the advantages described above could apply equally to basic research, it’s simply a matter of funding.

In sum, stem cells are a two-faced deal in China.  While there is certainly much legitimate research being done in China today, and even more of it to come in the future, the scientific community often has its reputation dragged through the mud because of the antics of high-tech snake oil salesmen.  And most unfortunately, many of the positive aspects of doing research in China, such as the large domestic market, the fairly permissive regulatory regime, and the lavish funding of therapeutic research, can simply aggravate illegitimate activities.  And I just thought of a very interesting research topic: these two worlds seem to be presented as two separate realms of activity, but it may be very enlightening to explore the ways in which they are linked or feed off of each other.  For instance, this post describes a biotech start-up offering commercial stem cell therapies, and this company has ties to a prestigious and world-class university that itself abides by international standards.  It may be that it’s not simply a matter of shutting out the quasi-legal stem cell market through better enforcement, because the relation between the two worlds may be more dynamic and complicated than that.

This profile entry will be periodically updated as I come across more information.

Posts Related to this profile follow.

On China’s international competitiveness in the stem cell science:

• Regenerative Medicine Report (2010): reviewing article entitled “Cultivating regenerative medicine innovation in China.”
• New England Journal of Medicine Summary (2006): reviewing article entitled “Bit Player or Powerhouse? China and Stem-Cell Research.”

On Reported Chinese Stem Cell Breakthroughs (not verified):

• Cellonis Biotechnologies (Beijing) & Glioma (2009).
• Nanshan People’s Hospital (Shenzhen) & Spinal Cord Injury (2006)

Just doing some general research on the progress of stem cell research in China.

Here’s an old 2006 editorial in the New England Journal of Medicine, entitled “Bit Player or Powerhouse? China and Stem-Cell Research.”

The editorial essentially declares that China has the potential to become a stem cell powerhouse, but it simply isn’t there yet.  China is accumulating stem cell expertise, but as of yet it does not have the scientific infrastructure required for creating an environment conducive to making scientific breakthroughs in the field.

What are the main problems?

1. Funding.  They emphasized that funding of stem cell science by the government is in fact extremely limited, despite all the press.  The editorial says that the Ministry of Science and Technology funds stem cell research through two projects (basic and applied research programs), and provided ~$12 million USD to each between 2000 and 2005.  Including local government expenses, the whole figure for government funded stem cell research in China, is only ~$38 million between 2000 and 2006.  The editorial also claims that private sources of funding are “distinctly immature” in China.
2. Small talent pool.  It also gives a list of several leading stem cell researchers in China, I might look each of those up later, and says that there are between 300 and 400 Ph.D.s working on stem cells and seven “top-notch” labs associated with stem cells.  The article takes note that the pool of lower level researchers is smaller, and promising students often go abroad for advanced training.   And while China generally loses its students-cum-scientists to the United States, this trend may already be reversing.
3. Limited collaboration.  The article faults Chinese scientists for being too intensely competitive in getting their worked recognized at the international level, rather than creating informal networks of domestic cooperation.  This latter point about informal cooperative networks is one that I haven’t come across before, as most critiques of the Chinese scientific infrastructure focus on rigidity in the scientific hierarchy or the hyper-excessive focus on publication numbers.

But then China has some aces up its sleeves:

1. Cost advantage.  The editorial predicts that China should be able to maintain a cost advantage by being able to cheaply produced standardized components required for stem cell research, like laboratory animals and equipment for stem-cell manipulation.  It is also conceivable that wages could remain depressed for lower level research workers and supporting staff.  However, while the article admits that wages and material costs will rise as China develops, it also claims that more sophisticated sectors will retain a cost advantage for some time.  I’d be interested in studying why this is.
2. Attitude towards embryos.  Here the editorial seems to conflate stem cell research, generally, with the moral disputes that occur over using human embryos in stem cell research.  I wonder how many of those labs are actually doing stem cell research involving human embryonic stem cells.  Having said that, the points it brings up are true.  A very small part of the Chinese populace gets as aggravated about the use of human embryos in research as many portions of Western civil society.  The most salient government restrictions involving experimentation with embryos are concerned with implantation of an experimented upon embryo rather than what happens to the embryo itself.  All in all, the article is probably correct that there won’t be much “moral politicking” about the issue.
3. “Scientific fluidity” in translating research into medicine.  The authors emphasize that most regulation and review of clinical trials in China continues to occur within an institution, through an institution’s own Internal Review Board, and absent an external body with review powers, like the U.S. FDA’s  mechanisms.  This gives scientists considerably more leeway if the IRBs don’t function effectively.  And effectively function they definitely don’t.  A portion of my seminar paper was on this aspect of the regulation of clinical research; there are definitely serious deficiencies in the composition and functioning of IRBs, at least outside of China’s major research centers.  But as this editorial says, the likelihood that conformance with global standards could occur is pretty high, there’s a lot of pressure from government officials and scientists alike to institute internationally acceptable standards.  The problem, as it always is in China, is implementation.

I think the whole article is a pretty fair assessment of the situation three years ago.  Certainly, the government has pledged much more funding in the latest Five-Year Plan, but I don’t know how those funding goals were actually affected by the recession.  China’s talent pool will definitely grow, and we’ll see whether or not China’s innovative ability actually increases.  That is a development I will be very interested in watching.  You hear a lot about the shortcomings of China’s scientific establishment, and I think the ability or inability of China to create a homegrown industry of innovation will teach the world a lot about what is required to foster creative thinking.  And even if China conforms to global standards, the harm to “scientific fluidity” might be offset by increased foreign collaboration that such standards would encourage.