Health

Banned!

Google prevents unproven medical treatment ads

Sunday, September 15, 2019

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EARLIER this month, Google announced a broad ban on advertisements on its online platform, to include a wide range of unproven medical procedures and treatments — including advertised stem cell treatments and gene therapies that have not been tested in rigorous clinical trials.

Scientific 'proof' that a treatment works comes from conducting clinical trials, which are the international 'gold standard' for determining whether a treatment is effective, as opposed to anecdotal claims by individuals who may have conflicts of interest in the matter.

In classic phase 111 clinical trials, not one or two individuals, but hundreds of patients are involved in the research of discovery. The patients who are afflicted are randomly assigned to groups, with one group getting the new treatment being studied while another group gets the treatment that is standard for the particular illness.

For the experimental treatment under study to be determined to be effective, patients receiving it must show statistically significant improvement over patients who were in the group receiving standard treatment.

Google protecting unsuspecting patients

Google decided that it will not allow advertising for treatments that have no established biomedical or scientific basis, and so announced a new health care and medicines policy that prohibited the advertising of any unproven or experimental medical techniques, including most stem cell treatments, cellular (non-stem cell) therapy, and gene therapy.

Its new policy went further, by also banning ads for treatments that may be rooted in basic scientific findings and preliminary clinical experience, but which do not yet have sufficient formal clinical testing to justify widespread clinical use.

Google stated that regulated clinical trials are the best way to test medical advances, and so implemented its policy to prevent harm to unsuspecting participants in these experimental treatments. The company stated that its new policy was necessary because it had seen an increase in 'bad actors' attempting to take advantage of individuals by offering untested, deceptive treatments.

Bad outcomes

These treatments often times can lead to dangerous health outcomes, and so Google decided that they had no place on its platforms.

In response, the International Society for Stem Cell Research, which is an independent non-profit organisation established to promote excellence in stem cell science and research through responsible guidelines and ethical practice, welcomed the new policy by Google. It regarded the policy as a much-needed and welcomed step to curb the marketing of unscrupulous medical products.

The premature marketing and commercialisation of unproven stem cell products threatens public health and the public's confidence in biomedical research, and therefore undermines the development of legitimate new treatments.

Consequently, the US Food and Drug Administration (FDA) has been cracking down on stem cell therapy clinics that promote unproven treatments. In June, the FDA won a permanent order prohibiting the Florida-based clinic, US Stem Cell Clinic LLC, from marketing its fat-derived stem cell treatments. The FDA further warned other clinic operators for prosecution.

Educating

Several stem cell clinics have opened their doors in our Caribbean countries over the past few years. However, the work being done inside these clinics should be regulated under laws similar to those governing the practice of medicine but setting the standards that should be met for such work with experimental treatments.

Nearly all Caribbean countries, including Jamaica, lack the required 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, and 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 and administered 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 strict clinical research conditions.

What patients should know

So, while patients have the right to seek treatments wherever they wish, the ethics of health care dictate that they need to be fully informed about all possible treatments, the risks, and the alternatives.

They should know when such treatments have not yet been widely accepted by the medical community because they have not been subjected to clinical trials research which provide 'proof' of benefit while simultaneously documenting side effects and possible harms.

Patients should also know that all new treatments may have as yet unknown risks with undesirable long-term consequences, hence the need for ongoing monitoring even after they have become generally accepted and widely available in the marketplace.

This monitoring has been shown to be highly beneficial and have led to product recalls, albeit infrequently.

It therefore behoves patients and their relatives to fully educate themselves on these matters, and it is also incumbent on our Caribbean governments to quickly adopt the draft legislation for research approved by the COHSOD (Council for Human and Social Development), but which has been languishing dormantly at the Caricom headquarters for the past four years.

Dr Derrick Aarons MD, PhD, is a consultant bioethicist and family physician; a specialist in ethical issues in health care, research, and the life sciences; the health registrar and head of the health secretariat for the Turks and Caicos Islands, and a member of UNESCO's International Bioethics Committee (IBC).


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