ALSUntangled 56: “ten red flags”-things to be wary of in alternative or off-label products, 2020

ALSUntangled 56: “ten red flags”-things to be wary of in alternative or off-label products

"Patients and families affected by disabling, life-shortening diseases such as amyotrophic lateral sclerosis (ALS) often turn to the Internet for answers (Citation1). There they can find a large number of alternative and off-label treatments (AOTs, 2), most being sold or offered in “trials” with a large up-front cost (Citation2). Proponents (persons advertising AOTs) sometimes make extraordinary claims such as “clinically proven”, “guaranteed” and “no risk” (Citation3). Unfortunately, the evidence backing up these claims can be flawed, inaccurate or altogether absent. Non-scientists may not always recognize the problems with such evidence (Citation4) and thus may over-estimate the potential benefits of AOTs. They may also underestimate the risks of AOTs which can include financial harms (Citation2) and physical harms (Citation5) to the individual, and scientific harms to the community (Citation6). Individual clinicians may not have time to perform the research required to educate themselves and their patients on the risks and benefits of AOTs.

In 2009, we started a program called ALSUntangled to help people with ALS (PALS) make better informed decisions about Internet AOTs (Citation7). There are three components to this program: determining which AOTs are of interest to PALS, objectively reviewing each AOT using a standard protocol, and, finally, crowd-sourcing and publication of the reviews."

"Conclusions

In conclusion, PALS and those with other incurable diseases often self-experiment with AOTs they find on the Internet. Information about these can be incomplete or inaccurate, leading patients to overestimate the potential benefits, and underestimate the potential risks. Individual physicians and ALSUntangled can be valuable resources for helping patients make more informed decisions about Internet AOTs. When these resources are not available, patients can look for the “ten red flags” described in this paper. In our opinion, the more of these that are present, the more wary patients should be."

https://www.tandfonline.com/doi/full/10.1080/21678421.2020.1765518#d1e193

 

The ten red flags described in the paper:

• Large out of pocket cost
• Advertised as effective for multiple incurable conditions with different causes
• Lack of safety and scientific oversight
• Absent or limited informed consent process
• Lack of an evidenced mechanism by which the intervention might help
• Absence of regularly measured validated outcomes
• Vague or no plan to present outcomes for peer review
• The only evidence of benefit is anecdotes
• Proponents have no relevant training, presentations or publications
• Proponents portray themselves as victims, advise “divorce” from mainstream doctors

 

Summary available in Swedish on ALS-fonden's website:

Så kan du känna igen tveksamma behandlingsmetoder
https://alsfonden.se/aktuellt/varning-alternativa-behandlingsmetoder

Many thanks to @MittEremltage for highlighting this valuable paper on her blog

ALS-fonden varnar för tveksamma behandlingsmetoder
https://mitteremitage.wordpress.com/2025/05/22/als-fonden-varnar-for-tveksamma-behandlingsmetoder/