In HBO’s “Silicon Valley,” fictional tech CEO Gavin Belson – played by Matt Ross – receives a blood infusion from a young donor.
A practice touted by billionaire Peter Thiel and parodied on the HBO sitcom “Silicon Valley,” whereby people receive infusions of blood plasma from healthy young donors, has gotten the attention of the Food and Drug Administration.
In a statement Tuesday, FDA Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research Director Peter Marks warned consumers against receiving plasma from young donors, a practice they said is unproven to be effective and potentially dangerous.
“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 statement read, although it did not tout any companies by name.
Nevertheless, one company that had received significant attention for the infusions, Ambrosia, issued the following statement on its website: “In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments.” The Monterey, California-based company’s website appears to have been scrubbed of any other information, safe for a generic contact form.
Business Insider reported last month that the company claimed to have locations in five US cities, charging $8,000 per liter – or $12,000 for two liters – of blood plasma from a donor aged 16-25. It had also run a clinical trial to test the effects of its treatments on age-related biomarkers for a variety of different disease states, including dementia, cancer risk, cholesterol and others. The news site reported that the trial, for which subjects paid $8,000 to participate, was run by a doctor in Monterey. However, the researchers on whose work the company’s services were based warned that it risked causing bodily harm.
But the FDA is warning that the practice carries numerous risks. Even though blood products are screened for infectious agents, the residual risk of contracting them remains. It can also cause severe allergic reactions, including anaphylaxis, acute lung injury and overload of the circulatory system. Moreover, the FDA said, there is no proven health benefit, and it has not been subjected to the kind of testing the agency usually requires.
Ambrosia’s clinical trial, which according to ClinicalTrials.gov was completed a year ago, was to enroll 200 patients in a single-arm design, rather than randomizing them. No data was published, but founder Jesse Karmazin – a Stanford University medical school graduate who is not licensed to practice medicine – told Business Insider they were “really positive.”
Photo: John P. Johnson, HBO
