Ambrosia, the controversial medical startup selling transfusions of youthful blood under the premise it confers anti-aging benefits, has swiftly ceased operations hours after the FDA issued an oblique statement suggesting the treatment has not been proven to be safe or effective.
For the last few years Ambrosia has been capitalizing on the age-old, but still unproven, idea that transfusions of young blood can result in a number of benefits for older patients. At one point Ambrosia's founder Jesse Karmazin even literally said, "It reverses aging."
By the beginning of 2019 the company had reportedly established six clinics around the United States, delivering young blood transfusions for between US$8,000 and $12,000 a pop. Although blood transfusions are technically legal in the United States, the company did purportedly undertake a clinical trial between 2016 and 2018 attempting to prove the treatment's anti-aging benefits. These results have yet to be published.
The FDA, clearly concerned about the growth of the off-label blood transfusion market, recently published an expansive statement warning consumers about the risks of these unproven treatments. Although the FDA statement does not specifically mention Ambrosia by name it does stress blood transfusions do not come without significant risks, and that there is no clinical evidence the treatment is beneficial for conditions such as Alzheimer's, Parkinson's, or general age-related memory loss.
"Simply put, we're concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies," the FDA states. "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."
Despite Ambrosia not being explicitly mentioned in the FDA statement, possibly due to the company skirting a legal grey area in administering the transfusions, within hours of the FDA statement being published the company stripped its website of anything other than a short statement claiming it had immediately stopped treating patients.
"In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments," Ambrosia writes on its website.
It is unclear exactly why Ambrosia so swiftly ceased operations in response to a reasonably abstract statement of concern from the FDA, but this is surely not the end of the line for this alleged fountain of youth treatment. While administering blood transfusions is not illegal, it is still against the law to promote medical treatments for a use that has not proven to be effective.
And, as the FDA sternly warns, "As a general matter, we will consider taking regulatory and enforcement actions against companies that abuse the trust of patients and endanger their health with uncontrolled manufacturing conditions or by promoting so-called 'treatments' that haven't been proven safe or effective for any use."
Source: FDA