Posted: 25 Feb 2019 06:34 PM PST
As difficult as it might be to believe, its true. In fact, last week, the FDA Commissioner, Dr. Scott Gottlieb, and the CBER Center Director, Dr. Peter Marks, issued a press release cautioning consumers against receiving “young donor plasma infusions” that are promoted as unproven treatments for varying conditions. Who knew??
Furthermore, this author then did a quick Internet search and it was not difficult to identify facilities that were, or had been prior to last week, promoting “young donor plasma” to treat disease. According to the FDA press release, the conditions offered for treatment included normal aging and memory loss to more serious diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease and post-traumatic stress disorder.
Historically, plasma has been used in trauma settings or for patients whose blood has been unable to clot. According to FDA, there is no compelling clinical evidence demonstrating the efficacy of using “young donor plasma” for Parkinson’s, MS, Alzheimers, nor any of the other novel conditions described above, nor is there sufficient information on the appropriate dosing for the treatment of these conditions.
Indeed, one can draw comparisons between the promotion of “young donor plasma” for these sundry conditions and the promotion of stem cells over the past decade for treating similar conditions, something that FDA has recently been trying to crack down on, with only moderate success thus far.
In the agency’s own words: “…we’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies. Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful. There are reports of bad actors charging thousands of dollars for infusions that are unproven and not guided by evidence from adequate and well-controlled trials. The promotion of plasma for these unproven purposes could also discourage patients suffering from serious or intractable illnesses from receiving safe and effective treatments that may be available to them.”
It will be interesting to see whether the market for “young donor plasma” subsides after this press release and, if not, how quickly FDA will act on what the agency is alleging as the promotion of a biological product for unapproved (and indeed unproven) uses.
Furthermore, this author then did a quick Internet search and it was not difficult to identify facilities that were, or had been prior to last week, promoting “young donor plasma” to treat disease. According to the FDA press release, the conditions offered for treatment included normal aging and memory loss to more serious diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease and post-traumatic stress disorder.
Historically, plasma has been used in trauma settings or for patients whose blood has been unable to clot. According to FDA, there is no compelling clinical evidence demonstrating the efficacy of using “young donor plasma” for Parkinson’s, MS, Alzheimers, nor any of the other novel conditions described above, nor is there sufficient information on the appropriate dosing for the treatment of these conditions.
Indeed, one can draw comparisons between the promotion of “young donor plasma” for these sundry conditions and the promotion of stem cells over the past decade for treating similar conditions, something that FDA has recently been trying to crack down on, with only moderate success thus far.
In the agency’s own words: “…we’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies. Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful. There are reports of bad actors charging thousands of dollars for infusions that are unproven and not guided by evidence from adequate and well-controlled trials. The promotion of plasma for these unproven purposes could also discourage patients suffering from serious or intractable illnesses from receiving safe and effective treatments that may be available to them.”
It will be interesting to see whether the market for “young donor plasma” subsides after this press release and, if not, how quickly FDA will act on what the agency is alleging as the promotion of a biological product for unapproved (and indeed unproven) uses.
.png)
No hay comentarios:
Publicar un comentario