Experimental stem cell treatments

Dr Derrick Aarons

Sunday, December 10, 2017

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SEVERAL stem cell clinics have opened their doors in our Caribbean countries over the past few years. However, the injecting of stem cells into the human body is not only relatively new, but also classified in international medical literature as experimental treatment.

This is different from 'standard treatment' to which patients are accustomed when they visit their doctors.

Accordingly, the work being done inside stem cell clinics should be regulated under laws similar to those governing the practice of medicine within the country, which laws should specify the standards to be met for research and experimental treatments.

Unfortunately for us in the Caribbean, only The Bahamas currently has regulations on this matter. Their regulations were specifically written to address the challenges posed by stem cell clinics that wished to set up business in The Bahamas.

A special application fee is required, as well as extensive details regarding what the applicants propose to do within those clinics. The application is then reviewed by an expert committee on the matter to determine whether permission will be given for such an establishment in the country.

No regulatory framework for protection

Nearly all other Caribbean countries, including Jamaica, lack the requisite regulatory framework to detail the standards to be met in carrying out the experimental treatments within stem cell clinics.

Regulations by their very nature exist to protect the public from harm, so where regulations on this matter are lacking, the public, who are rendered vulnerable by their serious illness, may be exploited through their lack of medical understanding.

Patients and their relatives need to fully understand the difference between standard treatment — which is widely accepted by the worldwide community of doctors — and experimental treatment, which is new and involves a lot of unknowns, and which therefore should be administered only under clinical research conditions.

In industrialised countries, experimental treatments are required by law to be first reviewed by a research ethics committee, and cannot proceed unless the proposal is approved by the committee. It is therefore a paradox (and perhaps insightful) that the countries from which the sponsors of these clinics come have well-developed laws and regulations to protect their own inhabitants in these types of research, while no such protection exists in the countries of the Caribbean.

Stem cell clinics are for-profit

Treatment in these business-for-profit clinics are highly expensive, and have been very controversial worldwide as several reports exist of baseless claims of cures, many adverse events, and even death in some circumstances.

In 2013, a 75 year-old woman with Alzheimer's disease died as a consequence of procedures from liposuction used to extract stem cells to treat her dementia condition. Hers was the first recorded death at a stem cell clinic in Australia.

The coroner was scathing in his assessment, stating: “While all medical and surgical procedures necessarily start off experimentally, there is a world of a difference between rigorously and ethically conducted clinical research trials that are reviewed at every stage by qualified medical peers, and this type of procedure which, in relation to the treatment of dementia, has some of the troubling hallmarks that are features of 'quack' medicine: Desperate patients, pseudo-science, and large amounts of money being charged for as-yet-unproven treatments!”

In countries such as ours that have no protective regulations, desperate people are at significant risk of becoming patients without the safeguards of well-designed clinical research which will ensure adequate oversight and transparency. Instead, in these circumstances patients tend to rely on an individual's testimonial (which asserts that it works for them) and anecdotal evidence, rather than on any internationally verifiable scientific evidence.

Potential yet to be fully realised

While stem cell research has great potential for the treatment of various conditions and diseases, the important caveat is that a lot more work is needed to ensure that this research translates into safe and effective treatments.

So far, the only established safe and effective stem cell treatment is haematopoietic stem cell transplantation — extracting stem cells from the bone marrow to treat blood disorders such as leukaemia.

All other uses are still in the experimental stage and, therefore, should be conducted only under the rigorous protection of a clinical research trial that has been reviewed and approved by a pertinent research ethics committee.

Unfortunately, some private clinics are skipping this critical step and are advertising stem cell-based procedures to the public through various media. Little or no mention is made of the risk of harm that may occur after receiving the advertised stem cell treatments, which may vary from allergic reactions, to rejection of the cells by the patient's immune system to, infection and possibly cancer. All of these complications can result in death.

Further, the treatments invariably impose severe financial hardship since stem cell-based therapies are customarily expensive, in many instances costing tens of thousands of US dollars. They also sometimes involve repeat treatments. Further, if anything goes wrong, there will be the additional costs for emergency care.

It, therefore, behoves patients and their relatives to fully educate themselves on these matters, and it is for our Caribbean governments to quickly adopt the proposed regulations for research that have been approved by the Caricom Ministers of Health.

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)


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