Tackling stem cell tourism: a comment by Robin Lovell-Badge

Opublikowane: 
2 sie 2011

Rogue clinics are the scourge of the serious enterprise of stem cell research and its application. They are a risk to patients and to a respectable field of scientific and clinical endeavour with very laudable aims. Therefore rational stem cell scientists will be keen to promote any realistic measure to deal with them. Many are taking action by working to produce agreed guidelines for best practice, and helping to educate regulators and members of the public. In an article published in EMBO Reports, Master and Resnik [1] argue that stem cell scientists should do more to tackle these rogue clinics by controlling access to materials and methods through documents called Material Transfer Agreements (MTAs). You can read a short summary of their proposal in our introduction. I do not think this particular strategy is useful for several reasons.

 

 

A practical problem
MTAs are in wide-spread use and funders often require scientists to use them. But how can MTAs stop unscrupulous clinics from using the cells? We don’t have the time or means as scientists to determine who should have access to materials, or to follow up on the use of materials by others. Instead, we have a moral duty to spend our time doing research to develop new or better therapies.

"MTAs could only help tackle rogue clinics if these clinics relied on scientists to get access to cells and materials"

Could MTAs be the right tool?
Even if time were no issue and individuals requesting materials could be thoroughly assessed, MTAs could only help tackle rogue clinics if these clinics relied on scientists to get access to cells and materials. I rather doubt that this is common practice. Many unproven treatments make use of autologous cells (cells from the patient’s own body, such as bone marrow), or cells harvested from a variety of sources over which stem cell scientists have absolutely no control. The safety of the stem cells themselves will depend on the source, as well as the cell type, method of isolation and how they are handled prior to transplant. In theory, clinics could even derive their own stem cell lines (embryonic stem (ES) cells, induced pluripotent stem (iPS) cells, neural stem cells etc). The extent to which the derivation and use of these cells were regulated would depend on the country. Most, if not all, of the methods and materials used to derive and manipulate stem cells are published – indeed, not to do so would be terrible for the field. It is our duty to distribute materials and explain methods to help advance the science, and many journals and funders quite rightly insist on this. Of course, rogue clinics don’t need to transplant any cells at all  – they can just pretend to do so and charge exorbitant amounts for possible placebo effects – although at least this should be safer than introducing cells with dubious origins or unlikely benefit.

Commercial practices
MTAs are usually involved when materials are to be used for research. If the materials were to be used commercially, as in the case of stem cell clinics charging patients for services, then a much more stringent licensing agreement would be negotiated and this is more likely to provide the occasion for in-depth investigation into the clinic offering treatment.

There are also companies that supply materials for stem cell research and use. These materials and cell lines should all have been subject to rigorous controls, and comply with strict manufacturing standards. If not, the companies would be open to litigation. However, as far as I am aware, there are few restrictions on companies regarding who they can sell materials and cell lines to. Perhaps this is an area that could be addressed, though most companies already choose to stipulate ’for research purposes only, not for clinical use’.

Would clinics pay attention to MTAs?
There may be reputable, well-meaning clinics that just do not understand stem cell science, or the problems of cell-based therapies, sufficiently well. It is a complex field, often not helped by confusion around the many different types of stem cell and what these cells may or may not be able to give rise to. MTAs and licensing agreements may help in this case. However, the more serious problem is rogue clinics operating without any scruples about their effects. I suspect the vast majority of these clinics would not care about MTAs and licensing agreements. We don't have time, expertise or authority as scientists to make decisions about the validity of clinics, and I expect our institutions and funding bodies would have little ability or authority to conduct investigations, especially of clinics in other countries.

"Stem cell scientists do have a duty to educate, not to over-hype their work and to be socially responsible; many already provide advice for patients"

What SHOULD we be doing about stem cell tourism?
Despite my criticisms and reservations, I agree with much of Master and Resnik’s article. Stem cell scientists do have a duty to educate, not to over-hype their work and to be socially responsible. Many respected stem cell scientists already provide advice that is available to all patients on websites such as those of the International Society for Stem Cell Research  (ISSCR), campaigning organisations like Sense-About-Science, research funders and many disease-specific charities. Moreover, of course, no respectable right-minded scientist would deliberately supply their favourite stem cells, or any reagents, to a clinic offering unproven treatments. However, this presupposes that they know that the clinic is bad. This is a problem if mere inclusion on a list of bad guys can lead to legal action, as recently discovered by the ISSCR. The organisation was recently forced to withdraw a programme to allow patients to submit the names of clinics online in order to have their credentials checked.

I would put the onus on governments to adopt robust regulations that are sufficiently flexible to accommodate the rapid progress of science, as well as measures to monitor and control activities relevant to stem cell research and treatments in their own countries. Ideally there should be common regulations and standards to permit exchange of knowledge, materials and clinical expertise, as has been argued by The Hinxton Group. This is where stem cell scientists can help: by lobbying governments and continuing to help educate regulators and the public.

It is early days, but novel treatments based on stem cell research will become an increasingly better option. It is up to us to ensure this happens. To do so we need to devote our efforts to the research, while engaging with the public in an honest fashion, pointing out not just the hope, but what is not possible, or not understood, or not there yet. If we gain their support in this way, they might also believe us when we issue warnings about charlatans and unscrupulous clinics.   

Guidance for patients

Many stem cell scientists already work with responsible organisations to help provide reliable information for members of the public. The International Society for Stem Cell Research has produced a patient handbook that includes a checklist of things to ask before taking up an offer of treatment.

Go to the ISSCR patient handbook

Related links

References
[1] Zubin Master and David B. Resnik, Stem cell tourism and scientific responsibility, EMBO reports advance online publication 29 July 2011; doi:10.1038/embor.2011.156.

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