A paper published on November 14, 2015 in the ‘BMC Medical Ethics’ Journal of the British Medical Council by professors at Wake Forest and Rice Universities in the USA, informed that disillusioned patients who had become tired of waiting on cures they were promised, had begun seeking unproven stem cell-based treatments that were causing more harm than good.

They stated that stem cell scientists appeared to have oversold their products.

In debates that occurred 10 years ago, scientists, foundations, and patient advocacy groups reportedly spoke of cures for chronic diseases that would come after the legalisation of embryonic stem cell research. However, these cures have been slow in coming, while charlatans and ‘snake-oil’ salesmen reportedly have been rapidly multiplying in the field.

Is the treatment safe and effective?

The authors noted that the rise in stem cell tourism was a recent phenomenon, and the continued marketing and use of experimental stem cell-based interventions, both inside and outside the United States, was problematic and unsustainable.

They informed that scientists have long envisioned that their stem cell research would lead to cures in the near future. Consequently, in 2004, patient advocacy groups in the USA lobbied and helped to pass and implement significant public policy and funding initiatives in stem cells and regenerative medicine. Later, advocates encouraged policymakers in Washington DC to broaden funding for embryonic stem cell research, and this was passed when President Barack Obama came into office.

However, the research using clinical trials has not yet been completed, and instead of waiting for the scientists to complete the research, patients are now approaching clinics around the world that have been offering experimental stem cell-based interventions.

Clinical trials are internationally regarded as the gold standard for determining whether a treatment really works as opposed to anecdotal statements or claims from individuals — who may have conflicts of interest — and whether the treatment is safe for general use in the population.  This evaluation does not involve small numbers of people, which can be deceptive.  Clinical trials traditionally enrol hundreds and sometimes thousands of patients to determine whether a treatment is effective.

The absence of regulation

Central to the concern regarding stem cell tourism is the lack of legal protection for such patients, liability standards, and the non-regulation of most of these centres or clinics where the stem cell-based treatments are being offered. The laws that cover the practice of medicine or pharmacy in countries of the Caribbean were written long before the advent of stem cell and regenerative medicine, and so do not stipulate any specific standards to be met or safeguards that would address the risk of various harms (physical, psychological, financial, etc) that could result from stem cell treatment.  

To date, there is not enough evidence of neither safety nor effectiveness for stem cell-based treatments, and so the professors stated that patients may be wasting both valuable time and money, as well as foregoing other possible treatment opportunities when they pursue these stem cell-based treatments.

Moreover, the current practices involving stem cell treatments do not contribute to generalisable scientific knowledge or progress — which research is supposed to do — since the data produced from the current stem cell treatments are unsuitable for any follow-up research to measure outcomes or verify the authenticity of findings or statements resulting, as they are not being done in a clinical trial setting.

Clinical trials

In classic phase III clinical trials, hundreds of patients are randomised to two or more groups, which will be compared. One group will get the treatment being studied, while another group gets the standard treatment for their particular illness. For a treatment to be determined to be effective, patients who get the new treatment being tested must show significantly better improvement over patients who were in the group receiving standard treatment. 

In the current state of stem cell tourism, there is also no assurance for patients that they are receiving the actual interventions promised — no independent quality assurance or regulatory oversight exists outside the particular clinic or establishment to review the work being done within — or what dosages they may be receiving. There have also been criticisms regarding inconsistent or non-existent follow-up monitoring and care for some patients who get such treatments.

The need for caution

So, whilst patients have the right to seek treatments wherever they wish, they need to be fully informed about all possible treatments and alternatives.

They should know when such treatments have not yet been widely accepted within the medical community because they have not been subjected to clinical trials research which provide ‘proof’ of benefit and also document side effects and possible harms. They should also know that all new treatments may have as yet unknown risks with undesirable consequences, hence the need for ongoing monitoring even after they have become generally accepted and widely available in the marketplace.

Consequently, caution should always prevail –

caveat emptor. Buyers beware

Derrick Aarons MD, PhD is a consultant bioethicist/family physician, a specialist in ethical issues in medicine, the life sciences and research, and is the ethicist at the Caribbean Public Health Agency – CARPHA.  (The views expressed here are not written on behalf of CARPHA)