FDA Issues Warning To Young Blood1 year, 7 months ago
Posted on Feb 21, 2019, 10 p.m.
The US FDA has issued a warning about young donor plasma infusions for profit, advising consumers to be cautious about getting infusions of young blood from establishments in their Safety & Availability guidance released Tuesday, February 19, 2019.
According to their release establishments in several states are offering plasma infusions to older adults that have been obtained from younger donors, some of which claim the infusions can help to reverse the effects of aging, and help treat a range of illnesses. Although parabiosis has been effective in animal studies the FDA warns their claims are not supported by any human evidence and suggest the procedure is associated with “infectious, allergic, respiratory, and cardiovascular risks.”
In a statement Scott Gottlieb and Peter Marks of the FDA say “we’re concerned some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as remedies and cures” but does not mention any “actors” in the release.
One clinic offering parabiosis (young blood) transfusion was the California based Ambrosia, which has announced in compliance with the announcement they have ceased patient treatments. The startup was found by Jesse Karmazin inspired by animal studies on the effects of mixing young and old blood in surgically conjoined mice which reported very promising results. According to the Huffington Post the clinic was charging $8000.00 for transfusions for a large treatment of two liters. This treatment may not have been affordable for everyone, but the pricing was reportedly at cost, and the company suggests it wasn’t making any money from it yet.
In an interview with Mic Karmazin was quoted as saying, “I want to be clear, at this point, it works, it reverses aging. We’re pretty clear at this point. This is conclusive….probably done with the clinical trial, it worked so well, we’re going to start treating people...it works, there’s really no question whether it works or not”.
However some doctors and researchers have cast doubts on his confidence, and are skeptical of his conclusions citing there are no published studies to demonstrate that the treatment is effective and without associated health risks; and the FDA states “there is no proven clinical benefit of plasma infusions from young donors” “..plasma is not FDA approved to treat other conditions…not guided by evidence from adequate and well controlled studies..” and encourage people to report any adverse reactions from administration of plasma from any clinic.
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