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  • 10 Red Flags: How to Avoid Misleading Claims About Alternative and Off-Label Prescription Drug Use

    Posted by Dagmar on July 6, 2020 at 3:31 pm

    ALSUntangled, 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.” (Quoted from the ALS Association June 2020 eNews Blog)

    The 10 red flags, published in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, are based on common shortcomings that 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 read the full document, use this link: The 10 red flags

    Did you find this list helpful? Have you felt overwhelmed or pressured by off-label marketers to buy their products? What are your thoughts about using treatments that have only anecdotal evidence to support them?

    Bill replied 3 years, 9 months ago 2 Members · 2 Replies
  • 2 Replies
  • Amanda

    July 7, 2020 at 1:22 pm

    Great information! Thank you for posting. There are so many scams out there, especially in the middle of a pandemic.

  • Bill

    July 7, 2020 at 2:35 pm

    Very good guidance. Item 1  large cost and item 6 lack of regularly measured validated outcomes and item 8 evidence of benefit is anecdotal ( at least after years ago studies). Wouldn’t this cause us to even question Riluzole and Radicava? My neurologists clinic and university specialists didn’t think either worth it for me. Big lack of data and all I hear from pALS is anecdotal good or bad and a lot of I’m not sure. Glaring lack at any attempt at data for pALS. Even after meds widely used. How difficult would it be to collect the data from the thousands of pALS attending clinics and correlate it to the meds we use. Just would need funding, the rest would be easy.

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