Health Experts Say Convalescent Plasma Therapy Require More Studies

Hahn, who called the development “promising”, said Trump did not speak to him about the timing of the announcement. He said “this has been in the works for several weeks.”

But some health experts were skeptical. Benjamin Corb, of the American Society for Biochemistry and Molecular Biology, called it “conspicuous timing”.

“President Trump is once again putting his political goals ahead of the health and well-being of the American public,” Corb said.

Rigorous studies are under way around the country, comparing similar patients randomly assigned to get plasma or a dummy infusion in addition to regular care.

But those studies have been difficult to finish as the virus waxes and wanes in different cities.

Also, some patients have requested plasma rather than agreeing to a study that might give them a placebo instead.

Former FDA commissioner Dr. Scott Gottlieb dismissed the suggestion of a slowdown.

“I firmly reject the idea they would slow-walk anything or accelerate anything based on any political consideration or any consideration other than what is best for the public health and a real sense of mission to patients,” Gottlieb told CBS’s “Face the Nation”.

Trump, in news conferences, “has made all kinds of therapeutic suggestions” that have not proven to be supported by science — and are even dangerous, Schaffner said.

That includes statements about the possible value of treating Covid-19 patients with ultraviolet light and disinfectant.

Trump reportedly also recently became enthusiastic about oleandrin, a plant extract derived from a toxic shrub that scientists immediately warned against.

But the president is perhaps best known for his early and ardent embrace of the malaria drugs hydroxychloroquine and chloroquine.

Earlier this month, Hahn emphasized that routine evaluation procedures will remain in place to evaluate Covid vaccine candidates.

“I think this administration has put more pressure on the Food and Drug Administration than I can remember” ever happening in the past, Schaffner said.

“Everybody is just a little bit nervous,” he said. 

(Writers: Jonathan Lemire, Mike Stobbe) 

Source: https://apnews.com/3296040fb1225ee7fa465d7baa5057da