The Office for Food and Drug Administration on Tuesday made a strong warning that the transfusion of young donor plasma sold for anti-aging and various diseases is not only not proven – they can be harmful.
You have probably seen the headlines of supposedly "" young blood "" a miracle cure where profitable medical startups charge thousands of dollars in other elderly patients with infusion of blood plasma in young donors. If the allegations made about these procedures sound too good to be true, this is because they are, according to the FDA.
Young donor plasma for the treatment or prevention of aging, and also for conditions such as Alzheimer's and Parkinson's disease, has "No confirmed clinical benefits", as those that are advertised and "potentially dangerous," said in his Statement by FDA Commissar Scott Gottlieb. Peter Marks, Director of the Center for Assessment and Research of Biological Agencies, joined him in issuing a warning.
They insisted on profitable young plasma companies trading in preterm labor for financial gain: "In simple terms, we are concerned that some patients are covered by unscrupulous actors promoting plasma therapy from young donors as drugs and remedies for Gotlib and Marx said: "Plasma advancement for these underestimated goals may also prevent patients suffering from serious or severe illnesses from receiving safe and effective treatments," they add.
At the end of December, HuffPost published an investigation into the Ambrosia whose launch is being sold by young people. Plasma treatment, which offers numerous potential benefits. The founder of Ambrosia, 34-year-old Jesse Carmazin, has earned widespread, ill-fated coverage in the media, despite the fact that no evidence that his transfusion actually helped people in the ways that he claimed helped people. Obviously is prohibited from practicing in Massachusetts by the authorities ̵
The Agency also categorically does not recommend people to carry out young plasma therapy outside clinical trials conducted under the "appropriate institutional control and regulatory oversight committee".
Companies usually need to obtain approval from the FDA before they can claim that the drug or medicinal product is being treated, treated, or prevented. Young plasma treatments have not gone through the "strict test" that the FDA usually requires in order to confirm therapeutic benefits and provide security, the agency said.
Karmazin, founder of Ambrosia, did not see the need for drugs to pass the FDA. The approval process of his study, in which participants paid for receiving plasma from young donors. He also never published the results of the study, although he advertised impressive results in the media, arguing that young plasma could help everyone from the level of Alzheimer's disease to blood cholesterol levels
. he told a reporter "but I think it's going to be pretty close."
Such claims are not only premature, according to the FDA, but the risks are surrounding plasma transfusion. In rare cases, complications may be fatal.
For patients receiving plasma for a recognized use, such as for the treatment of blood coagulation abnormalities, the FDA has determined that the benefits outweigh the risks.
I'm not really in the camp saying that it will provide immortality, but I think it's enough.
The founder of Ambrosia, Jesse Carmazin, speaking before the reporter
Gottlieb and Marx, also raised concerns about the dosage of young plasma transfuziyas. They indicated that they had seen a large amount of young plasma introduced to patients, which could create "significant risks," such as breathing problems and cardiovascular disease.
This is supported by what healthcare professionals said last year to HuffPost: someone who does not need blood transfusions will be at high risk for all things, short and long term, "noting that Phuoc Le, a physician and specialist in the world of health & I am teaching at the University of California, San Francisco . Lee was worried that Ambrosia claimed to give patients about 2 liters of plasma within one to two days.
As a rule, the FDA will consider regulatory and enforcement measures against companies "abusing patients' trust and jeopardizing their health … promoting a so-called" treatment "that has not been shown to be safe or effective for any use ", – stated in the statement
. Performed the vampire titles, not answering the main questions about the procedure effectively performing the role of free advertising for unproved treatment . (Report that Peter Till, a technological entrepreneur, a billionaire, was interested in young blood, and a parody of the "bloody boy" in the Silicon Valley of the HBO, promoted by the media. Karmazin did not even report to the journalists where he received his plasma.
HuffPost found that at least part of it came from a non-profit bank of blood in South Texas who recruited teenagers to "save lives "but noted that the blood components could be used for" the Bank decided to stop selling To start a young plasma after HuffPost has stretched out a hand.
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