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On Tuesday, the FDA issued a warning to anyone who would be inclined to give the impression of shaking his old bones with fresh blood from the young.
The idea is rather far from conventional wisdom, even in Silicon Valley, where the ultra-rich are keenly interested in cutting-edge science extension. Yet, the FDA apparently warns consumers of "unscrupulous actors" who tout the benefits of administering to plasma patients from young donors while extracting cash money from their customers:
The promotion and use of plasma for these purposes raises important public health concerns. There is no proven clinical benefit from infusing plasma from young donors to cure, mitigate, treat or prevent these conditions, and there are risks associated with the use of any plasma product.
Today we alert consumers and healthcare providers to the fact that plasma-based treatments of young donors have not been subjected to the rigorous testing normally required by the FDA to confirm the therapeutic benefit of a drug. product and ensure its safety. Therefore, the declared uses of these products should not be considered safe or effective. We strongly discourage consumers of [pursuing] this therapy outside clinical trials under appropriate institutional control and regulatory oversight.
With the new warning, all companies pursuing the controversial and currently unsupported scientific practice are aware. The best-known company in the field, Ambrosia Medical, reportedly began its own blood plasma transfusion testing in 2017. The FDA's new warning was aimed directly at the company, which appears to have bypassed the regulations in its wake. relying on the fact that blood transfusions are approved by the FDA, even though the company's marginal anti-aging applications are not.
On Tuesday, the sparse web site of Ambrosia Medical posted only one message: "In accordance with the FDA announcement published on February 19, 2019, we have ceased patient treatments." Warning.
In addition to the blatant absence of well-researched clinical benefits – "no convincing clinical evidence of its effectiveness", as the FDA says, it is very dangerous to fill up with unsupervised young blood from the government . The direct danger of blood-borne pathogens is aggravated by the other risks associated with the assay.
"Plasma is neither recognized nor approved by the FDA to treat diseases such as normal aging or memory loss, or other diseases such as Alzheimer's disease or Parkinson's disease," said the FDA. "In addition, the reports we see indicate that the dosage of these infusions may involve the administration of large plasma volumes that may be associated with significant risks, including infectious, allergic, respiratory and cardiovascular risks."
Ambrosia Medical appears to have completed its first study titled "Transfusion-Related Plasma Transfusion and Blood Fusion Biomarkers" in January 2018 and has remained relatively quiet since then. The study is registered with clinicaltrials.gov, although the research still appears to have gone beyond the confines of the government's institutional review and monitoring process. In its warning, the FDA did not call Ambrosia Medical, but instead described entities in the young blood business sector as "companies that abuse patients' trust and put their health at risk."
"In general, we will consider taking regulatory and enforcement action against companies who abuse patients' trust and put their health at risk due to uncontrolled manufacturing conditions or by promoting" treatments "that do not have not demonstrated their effectiveness or safety. use, "said the FDA.
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