Experts call for crackdown on 'stem cell tourism'

Chinese and European experts have jointly issued guidance calling for countries to tighten regulation of experimental stem cell therapies in an effort to deter the rise in so-called ‘stem cell tourism'. The experts identified concerns that certain countries allow stem cell trials and therapeutics to be marketed prematurely without having been adequately clinically tested for safety and efficacy. The ten multidisciplinary specialists in law, ethics, political science and social science examined the global burgeoning unregulated stem cell market over a three-year period as part of BIONET, a collaborative Sino-European initiative that evaluates the ethics of biological and biomedical research and practices between China and Europe based at the London School of Economics.

The BIONET Expert Group emphasised that safety and efficacy of stem cell treatments can be achieved through mandating clear and rigorous clinical trials and ethical reviews before a therapy may become available to patients. They felt doctors should be compelled to communicate honestly about the conditions and source of germ cells, embryos or embryonic tissue collection. Only those which were collected by methods compliant with the receiving country regulations should be imported for research. The Group proposed 30 additional recommendations which were presented at a final BIONET conference last week in London and included calls for international consensus on ethical issues related to biobanking and the establishment of a permanent China-Europe partnership on research ethics.

The conclusions addressed growing alarm among doctors that desperate and often vulnerable patients suffering incurable diseases are increasingly and potentially falsely enticed to travel to countries with more relaxed regulatory systems in pursuit of expensive and potentially unsafe stem cell treatments. '…If patients are to be properly protected, regulation needs to be enforceable and effective,' commented BIONET Expert Group co-chair Professor Qiu Renzong at the Chinese Academy of Social Sciences and vice-president of the Chinese Ministry of Health ethics committee.

Pharmaceutical companies conduct more clinical trials now in China than India. China plays a key role in coordinating effective global governance of this emerging economy and is home to approximately 150 institutions offering stem cell therapy, according to Qui Renzong, which cost foreign patients an average of £15,434. He acknowledged stem cell research is 'tremendously exciting' but emphasised it ‘must be governed in an ethical and responsible way if it is to fulfil its potential and not experience a backlash from public opinion'. In May, China introduced new regulations that require clinical trials before new stem cell treatments can be offered.

In a recent expose, The Times found that hundreds of UK patients were travelling and paying up to £30,000 for unproven treatments. They found that parents in the UK had been travelling to China to access a procedure marketed by the company Beike Biotech, which involved injecting umbilical cord stem cells into infants with congenital blindness. Beike Biotech admitted this weekend that it intends to, but has not yet, conducted any clinical trials validating the procedure and could not disclose success rates. Professor Pete Coffey of the Institute of Ophthalmology at University College London countered that there is no medical evidence that Beike Biotech's procedure works thereby placing these children at risk tantamount to 'child abuse'. A Department of Health spokesperson confirmed that the UK has 'strict regulation' protecting patients, but '...overseas based stem cell 'treatments' are 'particularly problematic' for regulatory oversight and jurisdiction.'