A split among the US government’s top scientists over the benefits of using convalescent plasma to treat coronavirus deepened on Tuesday, when a panel of experts convened by the National Institutes of Health said there was insufficient evidence to support its use.
“There are currently no data from well-controlled, adequately powered randomised clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of Covid-19,” the panel said in a statement.
The finding contradicted the US Food and Drug Administration, which recently awarded emergency use authorisation for convalescent plasma to treat coronavirus in hospital patients, and cast doubt on a treatment backed by Donald Trump, US president.
“This is what I’ve been looking to do for a long time. This is a great thing,” the president said after the FDA authorised the treatment.
The NIH panel said on Tuesday that it had reviewed both published and unpublished data on the treatment, and concluded that the evidence was “insufficient” and convalescent plasma “should not be considered standard of care for the treatment of patients with Covid-19”.
The medical experts said “prospective, well-controlled, adequately powered randomised trials” were still needed to determine the treatment’s efficacy and safety.
The FDA, a federal agency which is part of the US department of health and human services, has come under criticism on numerous fronts for its handling of the coronavirus pandemic.
Critics questioned the FDA’s approval of hydroxychloroquine, an antimalarial drug praised by the president, to treat coronavirus patients despite limited evidence that it was effective. The approval was later rescinded.
Last month, Mr Trump took to Twitter and accused “deep state” elements at the FDA of moving too slowly in approving new treatments for coronavirus.
The president accused the agency of “hoping to delay” treatments and vaccines until after the US presidential election on November 3, in an effort to undercut his re-election prospects, and tagged Stephen Hahn, the FDA commissioner, in his post.
One day later, the authorisation for plasma was issued.
Dr Hahn has been widely criticised for overstating the benefits of convalescent plasma, and told the Financial Times in a recent interview that he regretted his claim that plasma treatment would have saved the lives of 35 out of 100 patients. Data suggest that figure is closer to 5 out of 100.
“I certainly regret contributing to any misperception,” Dr Hahn told the FT last week. “I could have done a much better job last Sunday explaining relative risks.”
Dr Hahn will also be a central figure in US government decision-making about whether to approve a Covid-19 vaccine for widespread use. He told the FT that he was willing to bypass the normal approval process to authorise a vaccine as soon as possible, but insisted that he would not do so simply to please Mr Trump.
The FT reported last month that the Trump administration is considering bypassing normal US regulatory standards to fast-track an experimental coronavirus vaccine from the UK for use in America ahead of the election in November.