By forcing the Food and Drug Administration on Aug. 23 to approve blood plasma as a COVID-19 treatment under an emergency use authorization (EUA), President Trump again inserted politics into scientific research ― a situation that may create even more uncertainty about plasma as a potential treatment.
Plasma ― the part of blood that contains antibodies and proteins ― is still under investigation for this use, and those leading randomized clinical trials now far they may have difficulty recruiting new patients due to the controversy.
It seems we just can’t shake our obsession with youth or the idea or living forever. While the field of geoscience is legitimately working on ways to age longer and healthier, some companies are marketing unproven, potentially risky transfusions of “young blood” to those able to afford it or willing to ignore questionable and unproven claims behind the process.
Last week, the FDA said “enough.” Commissioner Scott Gottlieb, M.D., and the director of FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., issued a strong warning for consumers to avoid this unapproved and potentially dangerous therapy. Continue reading
Photo: Centers for Disease Control and Prevention/Amanda Mills (2011)
In the wake of criticism following the June attack at a gay nightclub in Florida, U.S. regulators are taking another look at the blood donation policy for gay men.
In a Federal Register notice, the U.S. Food and Drug Administration called for public comments about its donation policy, which calls on gay men to defer giving blood for a year following their last sexual encounter.
“The FDA said it was establishing a public docket for comment about its current recommendations and that interested people should submit comments, backed by scientific evidence, supporting alternative potential policies to reduce the risk of HIV transmission,” Reuters’ Toni Clarke reported on July 26. The agency is taking comments until Nov. 25. Continue reading
Last month’s shooting in Orlando in drew attention not only to the city’s gay community but also to limits in how the lesbian, gay, bisexual and transgender community there could respond when it comes to what many do in the aftermath of such tragedies – give blood.
The shooting at the gay nightclub left 49 victims dead. Many in the community sought to donate blood only to run into U.S. Food and Drug Administration regulations that call for sexually active gay men to wait a year after their last sexual encounter before giving blood. Continue reading