The Food and Drug Administration issued an emergency authorization for blood plasma as a coronavirus treatment, the agency and President Donald Trump announced Sunday — one day after Trump attacked the drug regulator for moving too slowly to back the treatment.
The agency held off on the decision last week over concerns from government scientists that evidence for the treatment’s effectiveness is thin, prompting Trump to accuse the FDA of slow-walking the therapy to harm his reelection chances without offering any evidence to support his claim. It is not clear whether the FDA has received additional clinical trial data in the last week that would support the therapy’s use.
Trump in a brief Sunday evening news conference appeared to oversell the FDA’s assessment, claiming the agency found plasma “safe and very effective.” The agency itselfsaid more rigorous study is needed to prove whether the treatment effective. Janet Woodcock, the head of FDA’s drug division who is now working on Operation Warp Speed, an interagency effort to accelerate coronavirus treatments and vaccines, on Friday told POLITICO that plasma has not been “proven as an effective treatment.”
An emergency authorization normally paves the way for expanded use of an experimental therapy. But FDA distanced itself from a full endorsement of plasma — which more than 70,000 Americans have already received — because patients have largely received it outside of randomized, controlled clinical trials that could prove whether the approach is effective.
Unlike Gilead’s remdesivir, which received an emergency use authorization months ago and has shown to benefit hospitalized patients, convalescent plasma “does not yet represent a new standard of care based on the current available evidence,” FDA said in a statement.
The Infectious Diseases Society of America says plasma treatment shows “some powerful signals” but noted there is still not enough data to understand its effectiveness for Covid-19.
Outside experts and former officials have accused FDA of caving to White House pressure during the pandemic — most notably in its decision to authorize emergency use of hydroxychloroquine for treating Covid-19 infection despite limited evidence. The agency later pulled the authorization after randomized clinical trials found it provided no benefit, but Trump as recently as this weekend complained about the agency’s reversal.
Hahn, a longtime cancer doctor, declined to contradict the president’s claims about plasma being “very effective” on the press briefing stage Sunday night. “If you are one of those 35 out of 100 people who these data suggest survive as a result of it, this is pretty significant,” he said.
The data from the expanded access program is not a randomized controlled clinical trial, making it difficult for scientists to eliminate other factors in patients’ recovery. Two randomized trials cited in the FDA’s emergency use authorization, in China and the Netherlands, were both halted.
The Chinese trial could not enroll enough patients. The Dutch trial ended after sponsors found “no difference in mortality, hospital stay or day-15 disease severity.”
An analysis of data on more than 35,000 patients enrolled in the Mayo Clinic program examined how they fared a month after receiving plasma. It found that a smaller proportion (21.6 percent) of patients who were given the treatment within three days of diagnosis died compared to people who received the treatment later in the course of their disease (26.7 percent).
But the study, published on Aug. 12 but not peer-reviewed, did not include a control group that would have allowed the researchers to determine whether the plasma treatment reduced the risk of death when compared to standard care.
A study by researchers at Houston Methodist hospitals reached similar conclusions. The 136 patients who received plasma were more likely to have survived a month post-diagnosis compared to 251 patients who did not get the treatment. The effect was strongest in people who were given plasma within three days of hospital admission. But the study, published on August 10 in the American Journal of Pathology, was not randomized or controlled. The doctors running the study gave every enrolled patient plasma, and later compared their outcomes to other people treated at the hospital.
There is more at the link above. But what is clear is this is an anecdotal result rather than a peer reviewed scientific study result. It works in less than 30% of patients if given in the first three days. It also is not studied as to why it may have helped those patients or maybe they simply would have gotten better with something else. We are dealing with already over 170,000 dead, I think we need to get this right, put the efforts to the studies, make the tests. Oh but the tRump declared it another game changer and get ready to open up the country and go back to it was before covid because … his economy and the wealthy needing the stock market need you to believe it is all OK. Hugs