The Food and Drug Administration issued a forceful warning Tuesday that transfusions of young donor plasma, which have been marketed to fight aging and a variety of diseases, are not only unproven ― they could be harmful.
You’ve probably seen the headlines about the alleged “young blood” miracle treatments where for-profit medical startups charge thousands of dollars to inject older patients with infusions of blood plasma from young donors. If the reported claims about those treatments sound too good to be true, that’s because they are, according to the FDA.
Injecting young donor plasma to treat or prevent aging, as well as conditions such as Alzheimer’s and Parkinson’s disease, has “no proven clinical benefits” like those advertised and is “potentially harmful,” FDA Commissioner Scott Gottlieb said in a statement. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, joined him in issuing the warning.
“It’s just a matter of time before there are going to be people harmed by this — and harmed by it, with no opportunity for therapeutic benefit,” Gottlieb told HuffPost in a phone interview.
He and Marks lambasted for-profit young plasma companies peddling an unproven therapy for financial gain: “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 promotion of plasma for these unproven purposes could also discourage patients suffering from serious or intractable illnesses from receiving safe and effective treatments,” they added.
“We’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies.”
In late December, HuffPost published an investigation into Ambrosia, a startup that sells young plasma treatments that offer numerous alleged potential benefits. Ambrosia’s founder, 34-year-old Jesse Karmazin, earned extensive, unskeptical media coverage, despite never showing any proof his transfusions actually helped people in the ways he claimed.
Karmazin — who cannot legally practice medicine in any state, and is explicitly prohibited from practicing in Massachusetts by authorities — announced recently he was soliciting customers in multiple states, charging $12,000 for two liters of young plasma. Other medical establishments, such as the Maharaj Institute in Florida, have also announced plans to charge patients for young plasma transfusions, and various studies of the treatments are ongoing.
Plasma transfusions have long been recognized as a treatment for particular health issues, such as for trauma patients. But the FDA urges people to be cautious and consult with their doctors before considering such treatments to combat aging or other conditions.
The agency also strongly discourages people from pursuing young plasma therapy outside of clinical trials conducted under “appropriate institutional review board and regulatory oversight.”
Companies generally need to get approval from the FDA before they can claim that a drug or medical product treats, cures or prevents a disease. Young plasma treatments have not gone through the “rigorous testing” that the FDA normally requires in order to confirm a therapeutic benefit and to ensure safety, the agency said.
Karmazin, Ambrosia’s founder, saw no need to go through the FDA’s drug approval process for his study, in which participants paid to receive plasma from young donors. He also never released the study’s findings, though he touted impressive results in the media, claiming young plasma could help everything from Alzheimer’s to blood cholesterol levels.
“I’m not really in the camp of saying this will provide immortality,” he told one reporter, “but I think it comes pretty close.”
Such claims are not only premature, according to the FDA, but risks surround plasma transfusions. In rare cases, the complications can be fatal.
For patients receiving plasma for a recognized use, such as managing clotting abnormalities, the FDA has determined that the benefits outweigh the risks.
“I’m not really in the camp of saying this will provide immortality, but I think it comes pretty close.”
Gottlieb and Marks also raised concern about the dosing of young plasma transfusions. They noted that they had seen reports of large volumes of young plasma being administered to patients, which can create “significant risks,” such as respiratory and cardiovascular issues.
This backs up what medical professionals told HuffPost last year: “In general, somebody who does not need a blood transfusion would be at great risk for all sorts of things, short term and long term,” by undergoing such treatments, said Phuoc Le, a physician and global health specialist who teaches at the University of California, San Francisco. Le was alarmed that Ambrosia claimed to give patients about 2 liters of plasma over just one to two days.
In wake of the FDA statement, the Ambrosia story can be seen in some ways as a media failure: Reporters ran with vampire headlines without answering basic questions about the procedure, effectively serving as free advertising for an unproven treatment. (A report that Peter Thiel, the tech entrepreneur billionaire, was interested in young blood, and the “blood boy” parody in HBO’s “Silicon Valley,” contributed to the media frenzy.) Meanwhile, Karmazin wouldn’t even tell reporters where he got his plasma.
HuffPost found that at least some of it came from a nonprofit blood bank in South Texas that recruited teenage donors for “saving lives,” but noted on a consent form that blood components could be used for “any other medical purpose.” The bank decided to stop selling young plasma after HuffPost reached out.
Generally, the FDA will consider taking regulatory and enforcement actions against companies that “abuse the trust of patients and endanger their health … by promoting so-called ‘treatments’ that haven’t been proven safe or effective for any use,” the statement noted.
The FDA is going to look at what enforcement activities it can take given “the scope of our concern,” Gottlieb told HuffPost.
“The first step was to put out a public health advisory alerting consumers and providers,” he said. “We’ll take it from here.”
This story has been updated with additional comments from Gottlieb.