The United States Food and Drug Administration has issued quite a forceful warning, this week, in regards to intentional transfusions of young donor plasma specifically marketed as a means to combat aging and a variety of associated diseases. You may be familiar with some of these ads, touting the “young blood” as miracle treatments, but there is apparently no proof to these claims. Of course, these claims come from for-profit medical startups who charge several thousands of dollars to inject older patients with this miracle plasma.
As such, FDA Commissioner Scott Gottlieb and Biologics Center Head Peter Marks are cautioning that not only are these advertised treatments ineffective, but they also pose certain risks. They argue: “The reported uses of these products should not be assumed to be safe or effective. We strongly discourage consumers from pursuing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight.”
Indeed, you may not be aware that these treatments do not undergo the handful of studies necessary to demonstrate the two most necessary components for legal sale: safety and efficacy. Accordingly, the FDA reviews and scrutinizes any such data before they will conclusively determine if a treatment is suitable for public sale.
And, in the case of these young blood transfusion treatments, the FDA has not issued such a declaration.
The pair of agency leaders go on to advise, “We’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures for remedies. Such treatments have no proven clinical benefits for the uses for which the clinics advertising them, and are potentially harmful.”
At the end of the day, they reiterate that the concern over “young blood” transfusions is thrice-fold. First of all, patients are being preyed upon by “unscrupulous actors touting treatments” as potential cures for conditions as serious—and complex—as cancer. Thus, patients are being swindled out of thousands of dollars. Secondly, though, patients are putting themselves at serious risk for unknown side effects. And finally—and, perhaps most importantly—the simplicity (and somewhat accessibility) of these treatments might discourage patients from pursuing proven treatments that, while having received proper purview, may be more expensive or complex in application.