Unproven stem cell trials peddle hope

“This is a very timely report as the US Food & Drug Administration (FDA) crack down on clinics advertising unproven stem cells approaches. It is a useful systematic analysis that not only demonstrates how biased the online advertising is, but also the predatory methods that many of these organisations use to convince individuals who are desperate for a solution.

The report also highlights the need for better education of the patient community, better regulation of unproven therapies, and the need for more research that will provide better “proven” treatment approaches.”

Unproven stem cell treatments are offered commercially and claim to improve symptoms or even cure neurological conditions, despite lack of evidence from clinical trials. Over the years, these have caused physical, financial, and emotional injury to people with Parkinson’s, their families and the community which is urgently calling for a cure, and investing funds and efforts to this end.

Found on clinic websites, YouTube and social media, patient narratives are powerful and persuasive: ‘‘a person like you’’ is deemed to be one of the most credible sources, and a powerful influence over decision making. YouTube has massive reach with over 1 billion users.

This is the first study to analyse YouTube infomercials of unproven stem cell treatments, as a means of better understanding them and thus combating them more effectively to protect patients and their families from harm.

159 YouTube videos of unproven stem cell treatments for a range of conditions, including Parkinson’s, amylotrophic lateral sclerosis (ALS), cerebral palsy, multiple sclerosis (MS) and spinal cord injury were analysed. These were released between 2007-2014, and had a total of just over half a million views, with over 100,000 subscribers, although videos can be viewed without subscribing.

All but 3 videos were published by clinics providing unproven stem cell therapies. Patient testimonials made up 93% of these videos, and patients were visible either through video or photos in 99% of these. The providers themselves appeared in just over half of the videos, asking questions directly to patients in 45% of the videos, for example about the patient’s health issues, why they chose to undertake the treatment, cleanliness of the facilities, or health benefits post treatment. In the 80 videos in which patients mentioned their country of origin, they were from the US, India and Canada, and given the location of the clinic delivering the treatment, it became evident that people had traveled to receive it.

In only 12% of these videos were the actual procedures mentioned, and only 10% contained information about risks, which were underemphasized. Benefits were mentioned in 95% of videos. Just 4 of these treatments were described as ‘‘experimental or controversial’’ and 2 were described as ‘‘alternative’’ but none as ‘‘unproven.’’

When the actual patient narratives were analysed, a few major themes emerged. The most dominant one was about benefits, followed by praise for the provider or treatment itself, the reason the particular clinic was chosen, and a recommendation of the treatment to others. In just over a quarter of the videos, the patient explained that the treatment offered hope, and the motivation behind choosing a stem cell treatment was also described. Notably, in a quarter of the videos the treatment was described as low or no risk, which is clearly misleading given the invasive, surgical nature of stem cell treatments.

Physicians and researchers play an essential role in the process of delivering evidence based medicine. Regulatory oversight is necessary.