FDA warnS against For-Profit Plasma Infusions

We wholeheartedly support the FDA’s recent warning against receiving plasma infusions from young donors by For-Profit companies.  In fact, as a 501 (c) (3) non-profit corporation who studies transfusions (not infusions), we ourselves have privately warned about the risks associated with these For-Profit Plasma infusion treatments for years.  To summarize the FDA (and YBI) position, we’ve highlighted below 4 key concerns from the FDA announcement, annotated with additional context:   

1. Infusions. Medically, infusions differ significantly from transfusions. Infusions add volume without taking anything away, creating risk of circulatory overload, swelling, and potential difficulty breathing.  It’s like adding water to an already full water balloon: the balloon will swell until…something else gives.   Transfusions, also known as “apheresis,” exchange blood components by taking away an old or damaged blood component and replacing it with a new donor blood component.  In fact, the very term “apheresis” comes from the Greek language and means “to take away.” During transfusions, highly skilled nurses program the apheresis machines to control patient’s blood volume to maintain the same volume while simultaneously removing old components and adding new components, thus minimizing risk of circulatory overload more probable in the case of an infusion.  
   
   
2. For-Profit.  With some exceptions, For-Profit entities typically do not yield new research benefitting humanity.  Rather, they seek to benefit shareholders through return on investment, dividends, and/or the sale of the entity to an acquirer.  And sometimes this private research may also benefit humanity, as in the case of the Grifols AMBAR studies on Alzheimer’s disorders over the last 10 years.  A For-Profit company does not typically qualify for humanitarian research grants to benefit society, instead choosing to fund research on its own in order to develop new lines of business.  Most of the For-Profit companies, doctors, and initiatives we know of who conduct infusionsseek to either sell plasma or sell procedures… but seem to do or care little to advance scientific understanding by evidencing or intending to evidence the results.
   
   
3. Plasma. As a human biologic, plasma donations vary significantly.  While Stanford and others have demonstrated safety in well-controlled, albeit small-scale, plasma infusion studies, data from the American Society For Apheresis (ASFA) suggests that use of Fresh Frozen Plasma (FFP) has historically resulted in a 57% incidence of transfusion reaction, as compared with a 4% incidence of transfusion reaction using 5% albumin as a replacement fluid.  We will post more on possible root causes for this disparity later, in a separate blog post.
   
   
4. Non-Studies.  The FDA cited lack of well-controlled studies to demonstrate efficacy and safety and inferred the For-Profit companies they warned of did not actually conduct clinical trials, instead offering “off-label” treatments not associated with any study. Aside from some of the young plasma infusion studies at Stanford on Alzheimer’s and Parkinson’s disorders, this would appear to be largely true.  Even the Stanford plasma infusion studies have been limited to small pilot studies designed largely to prove safety.  In reality, it cost more to conduct a study than provide “off-label” treatments: clinical trials require much more extensive and costly blood testing to document evidence of changes, particularly prophylactic changes that require early detection and more sophisticated equipment to prove a negative outcome or trend might have been prevented or mitigated; additionally, costs of pedigreed investigators, institutional review boards, and administrative overhead result in clinical trial costs which often range from $75,000 to $150,000 per subject.  Some biohackers and MD's alike often attempt to avoid the cost of clinical trial rigor to "fix" problems with no evidence or outcome to society.  

You can read the full Statement below from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions.
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https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631568.htm