Continued from the last post.

What are the current problems that China’s health care system has to cope with?

Thanks to China’s publicly financed health programs providing basic care in the 1960s and 70s, over the course of the last half of the century many of China’s health indicators (e.g. life expectancy, maternal mortality, malnutrition) have steadily improved.  But while China is in a much better health situation than most developing countries, problems still loom large.

In terms of mortality, China’s disease profile is similar to developed countries, meaning that 85%-90% of the deaths in China are caused by noncommunicable diseases and injuries.  Stroke, chronic obstructive pulmonary disease, and heart disease account for nearly 50% of all deaths, and much of this could be reduced by curtailing many of the risk factors in China, such as air, water, and sanitation quality; tobacco and alcohol consumption; diet and nutrition problems; and exercise deficiency.  I will be very interested in seeing how the Chinese government deals with these things.  I’ve seen concerted exercise efforts at least, but I know attempts to curtail smoking have been difficult to implement.  As for the injury deaths, 28% are due to suicide, 25% due to road traffic injuries, and 11% due to drowning.

Compare some of these to the United States’ statistics (in 2006).  The US’ top three killers are heart disease, cancer, and stroke; accidental injuries beat out suicide; and homicide actually sneaks into the top 15.

On the disease front, the major worries are:

• Tuberculosis: China is one of 22 high-burden countries, causing the death of 200,000 people yearly, with multidrug-resistant tuberculosis becoming an increasing public health threat (66,000 new cases every year).
• HIV: At the end of 2007, there were about 700,000 people living with HIV.
• Pandemics: China is also seriously concerned about diseases with a high epidemic potential, such as SARS, H5N1 (bird flu), and H1N1 (swine flu).  It was the SARS scare at the beginning of the century which touched off the increased concern with public health among Beijing’s leadership.
• Certain preventable diseases: Diseases such as malaria and cholera continue to occur, especially in the tropical border provinces and poorer regions of the country.

The government has an Expanded Programme on Immunization, which covers TB, poliomyelitus, diptheria, tetanus, pertussis, hepatitis B, Japanese encephalitis, meningococcal meningitis, hepatitis A, rubella, mumps and measles, leptospirosis, anthrax, and epidemic hemorrhagic fever.  The 11th Five Year Plan is seeking an immunization rate of more than 90% by 2010.

Next time I’ll get to the meat of this section, the actual steps taken by China to resolve their health care woes.

I’ve decided to devote a section of my blog to maintaining up to date profiles of certain aspects of Chinese Biolaw.  My first will be the reform of the Chinese public healthcare system.  I recently read a book called China: Bioethics, Trust, and the Challenge of the Market, which I have mixed feelings about, but it nevertheless had a wealth of information about the history and current status of China’s developing healthcare system.

There is currently no shortage of journal articles written on this topic.  However, information gets dated fast and the language barrier can also act as an impediment to the dissemination of information.  So I hope to create an easily accessible online index of valuable English and Chinese resources for doing research on China’s healthcare system, and continuously input any major updates.

I’m first looking at the WHO‘s current (2009) country profile for China.

Demographically and socioeconomically, it’s the same old story:

• The largest population, 1.3 billion people (although by 2025 India’s population is projected to be roughly commensurate with China’s);
• An aging population, by 2035 a quarter of the country will be more than sixty years of age; 
• An urbanizing population, by 2030 fully half of China’s population will live in urbanized areas (although the rural population as of 2007 was already 56%);
• A population lifted out of poverty, over the past 30 years ~400 million people have been lifted above the international poverty line (US $1) (accounting for ~75% of the developing world’s poverty reduction!);

Politically, healthcare is part of the vanguard of China’s new policy direction.  China’s 11th Five Year Plan (2006-2011) is seeking to introduce “five balances,” and among them is a balance between social and economic development.  The portion of social development that interests us here is the push to support medical care and public health.

This is a no-brainer for the Chinese; solving China’s health care problems will be a key part of resolving social unrest in China.  There are clearly existing and emerging trends in threats to the people’s health that are distributed primarily into environmental, workplace, and lifestyle problems.  The divide between rural and urban health and income continues to grow and is another one of the targets of China’s newest Five Year Plan.  Up to 30% of China’s poor state that health is the primary cause of their poverty (it leads to reduced earning capacity on top of potentially financially-catastrophic medical expenses).  The economic recession also presents dangers for China, because reduced local government earnings may interfere with local governments’ budgetary allocation for healthcare or even encourage them to seek extra revenue by increasing fees or otherwise reducing costs in the healthcare system.  Worse, despite the central government’s social development policy, countervailing economic considerations may encourage the promotion of consumption (e.g., unhealthy food, alcohol, tobacco) at the expense of health considerations.

This is the brief background presented by the WHO report.  I do not think I adequately presented the key link between China’s healthcare status and social unrest, but that’s really a topic in itself.  In the next post I will start giving the nitty gritty on health specific statistics and a description of the development of China’s healthcare infrastructure.

Okay, this is continued from yesterday’s post (Norweigian in Beijing: Successful Brain Cancer Treatment?).

The patient in the story was Arve Johnsen, a 36 year-old Norweigian whose glioma went into relapse and he was told there was nothing in Europe that could be done.  This 2008 article about Edward Kennedy describes the gliomas as generally being uncurable, i.e. they often relapse after several years. Then Arve found Cellonis, the creators of the treatment at issue, and he flew out with his family to try it out.  Cancer Stem Cells (CSCs) play an important role in this treatment, and in cancer in general, as they can be the cause of cancer relapses if traditional cancer treatments do not remove them from the body.  I think of them as stem cells’ bizarro-world counterparts.

So the treatment Cellonis uses consists of three components:  conventional cancer treatments, cell therapies, and Traditional Chinese Medicine.  Cellonis called it comprehensive cancer treatment (CCT).  They do not mention exactly which conventional cancer treatments are used, nor do they mention what type of TCM is used.  I would be very interested to know these things, as it seems like laying their cell therapies on top of conventional cancer treatments is already a handful, throwing in TCM into an experimental treatment seems messy.

The claimed cell treatment essentially uses the body’s own immune system to seek out CSCs.  They do this with dendritic cells (DCs, not related to neurons), which are part of the immune system.  They “digest” antigens (shapes of protein from a certain source that the body will then form antibodies to), then present those antigens to other cells in the immune system so that those cells know what to make antibodies to.  In Cellonis’s treatment, they take DCs and CSCs from the patient (I don’t know how easy or hard locating, removing, and culturing the CSCs), then lyse the CSCs and present them to the DCs so that the DCs can get ready to present antigens to the immune system.  Then at some point these primed DCs are put back into the body so the immune system can do its thing.

Arve Johnson arrived in Beijing August of this year, and as of the writing of the article (December 17), he had done two cycles of treatment.  They first used CCT, wherein the DCs were presented with SHG-44, a glioma cell line.  This glioma cell line only seems to be in use in China, as all articles that come up in a google search are based on work in China.  I’ll have to find a source which has a database on Chinese cell lines.  That didn’t work, and they did a second cycle with the DCs targeted to his CSCs (although the article isn’t clear if this was in addition to all of the other treatments or not) and the “results looked promising” but they were waiting for “more clinical trials to confirm the outcome.”

I suppose I’ll put it on my to-do list to check on this story in a month or so and see if anything came of it!

A week ago a story with this headline came out: For the First Time, a Glioma – Brain Cancer – may be Eliminated by a Chinese Research/Medical Team, Using a Novel Stem Cell Base.

Some research on the story:

Cellonis Biotechnologies: this is the owner of the therapy that was used.  Their website says that they are a China-based company headquartered in Beijing, and they have more than five years of research for the five different stem cell therapies under their belt.  Their website is kind of interesting.  First, the title is in Chinese (北京弘润天源生物技术有限公司, Beijing Hongrun Tianyuan Biotechnologies Co., Ltd.; I don’t know whether Hongrun Tianya is a cultural reference, it literally means Great-Smooth-Sky-Source), but the entire site is in English.  My guess is that they are definitely targeting foreigners looking for treatment (e.g. the Norwegian guy).  That and the fact that there is this extremely annoying floating advertisement that you can’t click out of.

Next, I don’t know how new that website is, but the sections listing their Science Advisors,  Board of Directors, and Management are under construction.  Although the article does mention that their CEO is one Cindy Hao, M.D., and their “Director International” (Maybe International Director?) is Urs J. Lienert, M.B.A.

Third, it says that they’ve established working relationships with Clinical Research/Treatment Centers (i.e. hospitals), but there’s no listing of what any of these are.  I suppose if you’re a potential client they would give you that information, but I wonder if there’s a business reason for not listing your clinical collaborators?

Fourth, I don’t really know how to find information on companies, I suppose I’ll learn that eventually.  Googling the English name only gets you news about the company.  Googling the Chinese name gets you a ton of job listing sites, which actually provide more information on the company.  However, I’ll have to find a directory for Chinese companies eventually if I want more detailed information.  I wonder if they post company registration information publicly?  On this HR site (and others) their company is listed as a private company with between 50-99 employees, and it looks like they’re hiring for positions at their headquarters and locations in Guangzhou (probably related to a subsidiary they have in HK) and Jiujiang (Jiangxi Province).  There’s nothing about Jiangxi in their website, but those positions are related to manufacturing/production.  The HR spiel does mention that their manufacturing workshops have gone through the SFDA’s GMP approval process.  That website says the company was founded in 2009 with Beijing University technical teams at the core, and already having ~4 years of research.  It also says the HK subsidiary was established to facilitate international exchange and cooperation.

Hmm, maybe I’ll write a little more on the actual therapy tomorrow.  This company research was interesting, but took a little longer than I thought it would.  There really isn’t too much information about the company itself out there, in the future I’d like to compare it to a similar-size American company that offers similar treatments, if there are any at all.

I came across this January 2009 Research Report on Chinese High-Tech Industries while doing some research.  It was published by the U.S. China Economic and Security Review Commission (USCC), and while it’s a little dated I think it’s still a worthwhile summary of the state of the biotech industry in China.  Best of all, it has some great details on the development of the biotech industry away from the coast.

The report analyzes three “sunrise industries” in China: biotech, nanotech, and electro-optics, mostly because developments in these fields have some important implications for U.S. and Chinese national power.  I only looked at the biotech section, but while there are some nice throwaway statistics, they aren’t presented in a very clear manner.

For instance, It reports that the modern biotech industry in China is ~8.8 billion USD in size, sales from “traditional biotech” reached ~44 billion USD, and 2,800 biotech firms employ ~40,000 researchers.  I am not really sure what they mean by the “size of the biotech industry,” maybe I just don’t know enough about that type of metric.  I wanted to compare some of this with U.S. stats, just as a frame of reference, so I looked up the Biotechnology Industry Organization’s statistics (this organization seems to be a lobbying/advocacy group for bioindustry) on the American biotech industry.  The first thing that popped out at me was that the U.S. had only 1,452 biotech companies, 336 of which were publicly held.  But in 2008 the total value of publicly traded biotech companies was $360 billion!  I wonder what that number would be if you threw in all the private firms?  And I wonder if that is the “industry size” they are referring to.  So that’s a question.  That BIO site actually has a bunch of interesting information, hopefully it will satiate me, because I don’t think I could afford any real market research.

And now that I think about it, I’m not really sure of the scope of biotech in either the USCC or BIO context.  The USCC report does mention some examples and talks about a “traditional biotech industry,” but I can’t really be sure if they’re being consistent every time they talk about it.  BIO’s Guide to Biotechnology seems to cast the widest possible net, calling every technology with its roots in biology a biotechnology. I suppose whenever I do research myself I’ll have to clarify this more!

The report does spend a bit of time on current biotech industry efforts and linkages with government/foreign institutions in five different cities, which is pretty interesting, albeit list-ful.  They go through Beijing (Biotech capital of China!), Shanghai, Tianjin, and more interesting to me–Harbin and Kunming.

Biotechnology is apparently one of the five major backbone industries of Harbin, and it has dozens of government and international projects.  The report focuses on a number of the Chinese-foreign collaborations, with countries/regions such as the U.S., the E.U., Israel, Japan, Korea, and of course, Russia.  All in all, it looks like things are looking up in that frozen corner of the world.  Maybe they save a lot of money with natural sample freezing!

They Kunming statistics are also very hopeful, although the report seems to jump between using Kunming and using Yunnan statistics.  Kunming’s government described biotech as a “huge resource, but small industry.”  And weirdly, 80% of Yunnan’s 320 biotech companies are involved in “the production and business of natural components and Spirulina.” I had to look it up on wikipedia, but that’s a type of cyanobacteria used in human dietary supplements and as animal feed in the aqua and fowl industries.  It seems pretty weird that that many companies are involved in this.  And what are natural components?  Maybe decades down the line after severe overpopulation, environmental degradation, and food crises, Yunnan  will become China’s “bacteria basket!”

Then the report goes on to talk about government policies, initiatives, and subsidies that benefit the the biotech industry, but I’ll spare you all that!

Traditional Chinese Medicine (TCM) has only come in tangentially during my research, but it is still an interesting topic to me.  TCM is undeniably a force in China.  TCM has it’s own government bureau, the State Administration for Traditional Chinese Medicine (中华人民共和国国家中医药管理局, note: their website was down at the time of writing this post), which is under the auspices of the Ministry of Health.  TCM and Western medicine exist side-by-side in China as facets of the public healthcare system, albeit sometimes antagonistically.  Even in China, doctors trained in Western methods are highly skeptical of TCM; but its cultural stature and pull means it continues to be a mainstay in Chinese society.

One of the current goals in China is the “modernization” of TCM, essentially a systematic rechecking of TCM medicines and methods through standard clinical and research trials.  And this is laudable, but what I did not appreciate were the inherent difficulties involved in assessing TCM based on “Western” methods (i.e. randomized controlled trials).  I was reading a report about research ethics in China, published by the UK’s Medical Research Council, and they had a section on TCM and precisely this problem.  To summarize, standardized TCM research in China can be difficult for five reasons:

1. Many TCM treatments, ideally, are individualized and holistic; it would be exceedingly difficult to set up truly randomized, controlled trials because it would be impossible to find similarly-afflicted individuals who require the same exact treatment.
2. Because much of TCM relies on herbal medicine, there are difficulties in purifying the proper extract in trials, because the unadultered plants or mixtures may have ingredients that interact with each other.
3. Standardization may be difficult because the proportions of different compounds may be different in each treatment using the same medicine.
4. Using a placebo in place of actual TCM may be ethically dubious in China, where practitioners and patients might believe that the efficacy of a certain treatment is already proven.  Ethically withholding that treatment is then problematic.
5. While assessing TCM treatment of some disease, you may be neglecting to provide a patient with Western medicine already proven to treat the patient’s disease.

I do not think that any of these are truly insurmountable difficulties; I suppose I am just once again struck by the observation that “holisticity” is such an easy gateway to unfalsifiability.  The idea that something is so complicated and dependent on other factors that it is unprovable.  Anything that toes that line inevitably risks association with disingenuousness and blind faith.

“Because such methods work, there is no reason to seek the causes of their effectiveness…In a tradition like that, you do not have to know why something works.  Rather, you just have to follow the example of others.  From knowing the past, one obtains those methods for ensuring one’s own existence.  Moreover, these methods are not isolated techniques; they are embedded in, and naturally carry with them a set of values.  When we say that some technique is effective (灵验), we mean that there is some unknown magic behind it.  If you use that technique, you will have luck; if you don’t, you will have problems.  Therefore, people grow up in awe of tradition.”

I am a 2L at Indiana University’s Maurer School of Law (Bloomington), and I was inspired to begin this blog after doing a fair bit of research for a seminar paper on globalization.  My topic focused on the regulation of biomedical research in China, specifically human research that involves biotechnologies like stem cells, cloning, and other techniques that periodically cause a bioethical uproar.  I’ll probably discuss parts of the paper in upcoming posts.

But the process of writing the paper required me to do the most in-depth research I’ve ever done, but what got to me was the fact that I read a very many great articles and books that I will probably not use in my paper, and will just end up shelving away for all eternity.  So I figured that, if I was going to do that, I might as well do it on the internet.

In any case, there are a couple reasons why I’m interested in China, Bio, and Law.

CHINA
I lived in China for a few years.  I was in HK for a year back in 1996, but did not really get interested in China until 2004, when I started going to to the mainland regularly to study Mandarin.  Generally I was only there for travel and language study (through Beida, Tsinghua, and self-study), but I have had two legal internships in Beijing (Grandall Legal Group) and Shanghai (Owens Corning) as well.  All in all I have lived in China for about 4 years, and can speak and read Chinese, although it’s taken quite a hit since I started law school.

But China has a special place in my heart.  I love the food, the language, the people, and I have ridden a lifetime’s worth of hard-seater trains.

BIO
The official reasons: I was a pre-med undergrad at Columbia University (CC ’06) and had been considering doing an MD/Phd program, so after graduation I worked at the Columbia University Medical Center in a neurobio lab.  That meant plenty of rat and mice dissections, and studying lots of apoptosis.  I worked in the Alzheimer’s research set of labs.  Although I did end up moving to China for a year, and then started law school, I did enjoy my time in the scientific world, and I am currently considering an MS in Biology following my upcoming graduation.

The unofficial reason: huge sci-fi buff.  Kim Stanley Robinson, Dune, Ender, Douglas Adams, Asimov, the 5th Element, STTNG, SG1, Firefly, et cetera, et cetera, et cetera.

LAW
Well, I’m in law school, and I’ve studied a little bit of Chinese law.  Not in any practically useful sense, but enough that I am pretty familiar with how the government functions and how the law does what it does.  And I think it’s fascinating!

I’m also a licensed patent agent.  Without any actual experience, yes, but I am very interested in intellectual property.

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That’s about it.

I can be contacted here: andrei[at]chinabiolaw[dot]com.

And here’s my LinkedIn profile.

Welcome to BioLaw with Chinese Characteristics!

• This blog is dedicated to publishing news and analysis focused on topics of bioethics, biotechnology, and the biological sciences in China’s legal world.  I want to inform you of the latest happenings and discussions in Chinese government and society by providing access to Chinese-language sources, as well as share my research and thoughts on developing issues in these areas.  My goal is to present, at a daily weekday posting rate [Editor's Note: Yikes, that was a little too ambitious for a full time student, I'll put in a solid hour of research or writing a day, and see where that gets me.] content that interested readers may not otherwise find readily available. 

• Scientific and technological breakthroughs in biology are occurring at an accelerating pace.  Advancements and projects that the scientific community expected to bequeath to the next generation are coming into fruition in the present day, and the radical nature of emerging biotechnologies brings with it greater potential to upset the societal status quo.  Biological discoveries fundamentally reshape our understanding of  human behavior and put the limitations of the human mind and body in stark relief.  New medicines and treatments made possible by biotechnology are forcing us to confront, both individually and as a society, moral and ethical choices that were unimagined decades ago, and that many still mistakenly believe remain confined to the pages of science fiction.  A thorough understanding and critical awareness of bioscience, biotech, and bioethics  will be essential to navigating the upcoming waves of the bio-future.

• One nation that will figure prominently in that bio-future is China.  Despite facing the harrowing consequences of decades of single-minded economic development, China has diligently sown the seeds of scientific revolution.  China has pulled out all the stops when it comes to bio-industries, and is massively investing in scientific education and facilities, actively attracting and retaining foreign talent and technology, and making concerted efforts to create the conditions necessary for thriving domestic innovation, entrepreneurship, and markets.  The factory of the world will soon become the laboratory of the world.  While laws and policies of China’s government and the Chinese Communist Party were pivotal in setting these forces in motion, there is still a dearth of public understanding in the English-speaking world about the mechanisms of governance employed by these entities.  Given the proportionately large role that China will play in the science and business of biology, it is paramount that both partners and competitors have an adequate grasp of why, where, and how the Chinese legal system and related institutions both function and fail.

• I have a handful of behavioral preferences firmly-hardwired into my brain: I love eating Chinese food,  I love reading science fiction, and I love figuring out new sets of rules.  The trajectory of these interests may be what led me to the fascinating story of a rising China, to the existential possibilities of the biological sciences, and to the overwhelmingly complicated maze that is human governance.  (Or mis-governance, or non-governance.)  Combine that with my impressive internet trawling stamina and the great pleasure writing gives me, and it may very well be that BioLaw with Chinese Characteristics was a deterministic inevitability.

In closing, please read, learn, think, and respond!