ALSUntangled, an award-winning website dedicated to helping people with ALS figure out whether alternative and off-label treatments are effective and appropriate, has created a list of 10 red flags people with ALS should be aware of when considering off-label treatments they read about on the Internet.
“The first place a lot of people go with questions about drug treatments is the Internet,” said Dr. Richard Bedlack, director of the Duke ALS Clinic and head of ALSUntangled. “Unfortunately, some of what they find there is not rooted in science and can actually cause significant harm, both financial and physical.”
When the Food and Drug Administration approves drugs for use, it establishes specific guidelines laying out the symptoms and diseases the drug or biological product is approved to treat, a process known as drug labeling. FDA does not prohibit doctors and other health care providers from prescribing drugs for uses that have not explicitly been approved by the agency.
ALSUntangled was launched in 2009 to provide people with ALS who turn to the Internet make better informed decisions. A panel of 120 clinicians and scientist from around the world review the evidence of off-possible label uses that has been identified by the community. A primary investigator assigned to the emerging off-label use looks into five categories to determine whether the alternative use is viable. The full panel in turn reviews the findings of the primary investigator before ALSUntangled publishes a final recommendation on alternative uses.
The 10 red flags, which were published recently in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, are based on common shortcomings the ALSUntangled team finds in emerging alternative and off-label treatments that people in the ALS community ask them to review. Over the years, they have published 55 reviews of alternative and off-label treatments.
The common red flags identified include:
- Large out of pocket costs
- 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 relative training, presentations or publications
- Proponents portray themselves as victims, advise “divorce” from mainstream doctors
To learn more about the many treatments Dr. Bedlack and his team have evaluated, visit their website or follow them on Twitter at twitter.com/ALSUntangled. To pose a question about a specific alternative or off-label treatment, you can email ALSUntangled directly or post your question on Twitter using the hashtag #ALSUntangled