The ‘Spring of Bioethics’ in China

Emerging Bioethical Orders and New Spaces of Participation

Orders and Disorders

Outline PresentationContext

Emerging Bioethical Landscapes, Modalities and Limits of Participation

Voices

Commercialized Forms of Experimental Stem Cell Therapy

Regulations Ordering the

Disordered

Conclusions

Bioethics and the emergence of Civil Society

Under Construction!

Deconstruction?

Context - Emerging Bioethical Orders

‘Spring of Bioethics’ in China:

New Possibilities and Modalities of Participation

Limits and Dangers Fercap Health NGOs

Pro-Democracy Demonstration Hong Kong October 1 2009

Case - Commercialized Forms of Experimental Stem Cell Therapies

Contrasting Voices 1 - International Science Journalism Stem Cell Therapy or Snake Oil?

“Desperate patients traveling abroad for dubious stem cell treatments. Monya Baker investigates the damage not only to human lives but also to reputable stem cell research.”

Source: Nature Biotechnology, Vol. 23, No. 12, Dec. 2005

Author: Monya Baker

Patients warned about unproven spinal surgery

“Pressure is mounting on a Beijingneurosurgeon to prove that hispopular treatment for spinal-cordinjury works. In an articlepublished last month, a groupof spinal experts concludes thatthe treatment, which involvesimplanting fetal cells into the spineto promote nerve-cell regeneration,has significant side effects and doesnot provide any benefit.”

Source: Nature, Vol 440, 13 April 2006 Author: Cyranoski, D. (2006)

Contrasting Voices 2: The Insider’s View “There are many, many problems with stem cell therapies in China. There is no

nation-wide [set of] standards that regulates clinical experiments and clinical trials. […] You know there are many small, private hospitals, owned by a… a boss, who wants to earn money. They will advertise on the television and the radio and many patients will be attracted. They provide several therapies, you know, “therapies”, against cancer, and several other chronic diseases. […]. There are many lost patients in China, because… [long break] the situation is very chaotic [ 乱 luan], and there are no regulations yet.”

[Dr Wang – stem cell researcher involved in clinical trial in Beijing]

Case of Clinic in Henan Province – clear case of patient deception, amount of stem cells injected too low for therapeutic success

It becomes clear that stem cell tourism is only the top of the iceberg, the majority of patients in estimated 150 clinics are patients from China

(source: http://www.nature.com/nature/journal/v440/n7087/full/440992b.html)

Support by Local MOH Bureas

Support by Local MOH Bureaus

Contrasting Voices 3: Enthusiast and Uncritical Media

Title: 干细胞移植治疗糖尿病西部首个成功案例出院、 “First case of successful treatment of a

diabetes patient by Stem Cell Transplantation Treatment in Western China”

2009-06-18 来源 : 重庆晨报 (Source: Zhong-Qing Morning

News) 作者：何薇 (Author: He Wei)

Contrasting Voices 4 – Critical Media

干细胞治疗是否已能用于临床 ?

记者的问题 : “ 一位比脑瘫程度要轻的智力发育迟缓的孩子能否进行干细胞治疗 ?”

医院长院回答 : “ 这种情况我们能治。一般通过干细胞静脉注射或腰椎穿刺的方法就可以。腰椎穿刺效果会快一些，治疗 3~4 次就能看到效果” . 该院崔院长非常肯定地说。

来源： 北京青年报 (07/08/13 00:37)

“Should Stem Cell Treatmentsalready be used in ClinicalTherapies?”

Question of Reporter: Can a child that as a result of a light form of brain

paralysis ( 脑瘫 ) suffers from intelligence and learning retardation receive stem cell treatment?

Reply of Hospital Manager Cui: ‘This kind of condition we can cure. In general the

carrying out of intravenous (?) stem cell injections or the method of lumbar vertebra puncture are possible. The results of lumbar vertebra puncture are a little but faster, with 3-4 treatment rounds it is thus possible to see results’. This is what hospital manager Cui said with extraordinary firmness.

Now the journalist opposes this statement with expert views and he answers his introductory question negative

Source: Beijing Youth Newspaper, August 13, 2007

Contrasting Voices - Bioethical Plurality An International View - BIONET

“We must protect desperate patients from themselves”

(Genevra Richardson, BIONET Conference London)

“Treatments that are at an experimental stage should be planned as clinical studies, and rigorous, scientific and ethical review should be sought”

(BIONET Workshop Report 4)

Contrasting Voices - Bioethical PluralismNational-Level Perspective 1

她强调，所有干细胞的研究，在临床应用之前一定要经过临床试验，不能从实验室就直接进入常规的临床治疗。 All forms of stem cell research, before they are used in the

clinics, must certainly undergo clinical trials. You can not directly move from the laboratory to the routines of clinical application.

(Zhai Xiao-Mei, Beijing Union medical Hospital)

Source: 财经网 Caijing Net, April 4 2009

Contrasting Voices - Bioethical PluralismNational-Level Perspective 2

Many patients ask for these treatments and indicate benefits and satisfaction afterwards. So why stop these treatments completely?

In case of continuation a necessary precondition would be however:

Fully informed consent on: clinical risks Uncertainty on Treatment Efficacy

(paraphrased opinion frequently encountered in conversations with bioethicists in China)

Contrasting Voices 5 - Critical Scientists

Huge Number of Scientists are highly critical with regard to unproven stem cell treatments and they ask for consistent regulations, not only for the control of commercial stem cell treatments but also for systematized clinical Trials

Various ways of engagement existThrough professional organizations such as the Chinese

Society of Stem Cell Engineering Through informal contacts with administrators in the

MOH and MOSTThrough invited Participation in MOH/MOST related

committees and expert groups

New Regulation Valid since May 1

Addresses all forms of experimental therapies

Implementation procedures foresee: registration (before December 1

this year) Subsequent evaluation through

visiting expert commissions who work along clearly specified and nationally binding criteria

Predefined forms of punishment and sanction

Precise strategies and criteria are in the process of being worked out these days

Conclusion Gradually emerging participatory sphere of

politics in China Increasing transparency, possibility of

criticism and feedback

Institutionalized Bioethics in China operate closely within existing political structures

Criticism is possible, but only along accepted and predefined lines

Civic Engagement – non-government related – remain undesired, operate under danger

Not only Bioethics Activism but Science Activism (this point remained underexplored)

Role of Internet Activism beyond Bioethics and Science

The Internet Emerging Patient Organizations