The FDA is warning consumers not to infuse “young blood” into their bodies to treat various ailments. According to FDA commissioner Scott Gottlieb, bad actors and charlatans market blood products from “young” donors as treatments for Alzheimer’s, Parkinson’s disease, heart disease, and post-traumatic stress syndrome.
In the statement, Gottlieb says the “young blood” is not safe for use. He outlines numerous concerns regarding the plasma and the companies that sell the product.
“We strongly discourage consumers from pursuing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight.”
Companies promote the infusion of plasma to treat various ailments. However, the FDA says that plasma infusion is only beneficial for patients with bleeding and clotting abnormalities. Plasma is also useful for some trauma patients with clotting related issues.
For individuals with normal clotting, plasma can overload the body and cause considerable health issues.
“The more common risks are allergic reactions and transfusion associated circulatory overload and less common risks include transfusion related acute lung injury or transfusion associated circulatory overload and infectious disease transmission.”
The FDA says there is no proof that the “young plasma” does what centers allege it will do. Currently, there is no clinical evidence the plasma is helpful in the treatment of any disorders. Additionally, there is no information on appropriate dosing.
Charlatans selling the “young blood” often give patients large volumes of the plasma. Large doses of plasma can lead to infections, allergic reactions, cardiovascular and breathing issues.
Most concerning to the FDA is that vulnerable and sick consumers are being preyed on by companies promoting the treatment.
“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.
The promotion of plasma for these unproven purposes could also discourage patients suffering from serious or intractable illnesses from receiving safe and effective treatments that may be available to them.”
Additionally, the FDA says they will use any legal means necessary against the centers pushing the treatment.
“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.”
Consumers are encouraged to speak with their physician before beginning treatment. The FDA recommends consumers to verify with the clinic on their enrollment status in clinical trials.
If the company cannot provide the investigational number, the FDA recommends not using the facility for the treatment.
Finally, the FDA urges patients to report any adverse reactions through their online reporting system.
“Furthermore, we urge patients and their health care providers to report any adverse events related to treatment with plasma from young donors for aging or related indications to the FDA’s MedWatch Adverse Event Reporting program. The agency will continue to closely monitor this issue and take additional steps, as appropriate, along with state and local health departments and blood establishments.”
*Katie Joy is a columnist and hosts Without A Crystal Ball on Patheos Non-Religious Channel. She writes articles on parenting, disability advocacy, debunking pseudoscience, atheism, and crimes against women and children.
She co-hosts the YouTube show, “The Smoking Nun,” with Kyle Curtis. The show airs weekly and tackles pseudoscience, current events, and crime stories.
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