Young Blood Scam: FDA warns against unproven anti-aging transfusions

The Food and Drug Administration on Tuesday issued a strong warning that plasma donor transfusions, which have been marketed to fight against aging and various diseases, are not only proven, they can also be harmful. .

You have probably seen the securities sure the alleged "new blood"Miracle treatments where for-profit medical companies charge thousands of dollars to inject old patients with blood plasma injections from young donors. If the claims about these treatments seem too good to be true, it's because they are, according to the FDA.

Injecting plasma from young donors to treat or prevent aging, as well as diseases such as Alzheimer's disease and Parkinson's disease, has "no proven clinical benefit" as advertised, and is "potentially harmful, "said Scott Gottlieb, FDA Commissioner, in a statement. Peter Marks, Director of the Agency's Center for Evaluation and Research on Organic Products, joined him in launching the warning.

They harassed young, for-profit plasma companies with unproven treatment for financial gain: "In simple terms, we are concerned that some patients may be targeted by unscrupulous actors touting plasma treatments of young donors as remedies. and remedies, "Gottlieb and Marks told me.

"Promoting plasma for these unproven purposes could also discourage patients with serious or intractable diseases from receiving safe and effective treatments," they added.

At the end of December, HuffPost published an investigation on Ambrosia, a startup that sells young plasma treatments with many potential benefits. 34-year-old Ambrosia founder Jesse Karmazin received extensive media coverage with little skepticism, although he never proved that his transfusions really helped people in the way he claimed .

Karmazin – who can not legally practice medicine in any state and is explicitly forbidden to practice in Massachusetts by the authorities – announced recently he solicited customers in several states and charged $ 12,000 for two liters of young plasma. Other medical institutions, such as the Maharaj Institute in Florida, also announced plans to bill patients for young plasma transfusions, and various studies treatments are in progress.

Plasma transfusions have long been recognized as a treatment for certain diseases. health problemsas for traumatized patients. But the FDA urges people to exercise caution and consult with their doctor 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 "an appropriate institutional review committee and regulatory oversight".

Companies usually need to get FDA approval before they can claim that a drug or a medical product is treating, caring for or preventing a disease. Plasma treatments in young people have not undergone the "rigorous testing" required by the FDA to confirm therapeutic benefit and ensure safety, the agency said.

Karmazin, the founder of Ambrosia, did not see the need to go through the FDA drug approval process for his study, in which participants were paying to receive plasma from young donors. He also never published the results of the study, even though he touted the impressive results in the media, claiming that young plasma could help everything from Alzheimer's disease to blood cholesterol.

"I'm not really in the camp to say that it will bring immortality," he said. told a reporter, "But I think it comes pretty close."

Such claims are not only premature, according to the FDA, but the risks associated with plasma transfusions. In rare cases, the complications can be fatal.

For patients receiving plasma for recognized use, such as the management of bleeding abnormalities, the FDA determined that the benefits outweighed the risks.

Gottlieb and Marks also raised concerns about the dosage of young plasma transfusions. They found that they had been informed that large amounts of young plasma had been administered to patients, which may result in "significant risk", such as respiratory and cardiovascular problems.

This confirms what health professionals told HuffPost last year: "In general, a person who does not need a blood transfusion would be at great risk for all kinds of things, in the short and long term" by undergoing such treatments, said Phuoc Le, doctor and global health specialist who teaches at the University of California at San Francisco. The was alarmed by the fact that Ambrosia claimed to give patients about 2 liters of plasma in just one to two days.

In general, the FDA will consider taking regulatory and enforcement action against companies that "abuse the trust of patients and put their health at risk … by promoting" treatments "that are harmless. and the effectiveness has not been proven, "the statement said. .

As a result of the FDA's statement, the story of Ambrosia may be considered in some ways as a media failure: journalists made headlines without talking about vampires without answering basic questions about the procedure, effectively serving as free advertising for unproven treatment. (A report Peter Thiel, the billionaire technology entrepreneur, was interested in young blood, and in Parody of "blood boy" HBO's Silicon Valley contributed to the media frenzy). Karmazin would not even have told reporters where he had his plasma.

HuffPost discovered that at least part of it came from a nonprofit blood bank in southern Texas who recruited adolescent donors to "save 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 mobilized.

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