Washington/New York: A panel of experts convened by the National Institutes of Health undercut an emergency authorization issued just days ago by U.S. regulators, saying there’s not enough evidence to recommend use of convalescent plasma for hospitalized coronavirus patients.
In an escalation of a dispute between federal agencies, the NIH advisers said an analysis of a study showed “no difference in 7-day survival overall” among those who received plasma containing high amounts of antibodies.
The statement contradicts inflated claims made at an unusual Sunday night press conference at the White House a week ago, where Food and Drug Administration Commissioner Stephen Hahn and President Donald Trump said convalescent plasma could cut deaths from coronavirus by 35%.
Hahn subsequently apologized for mischaracterizing the benefits of the therapy, which takes infection-fighting antibodies from the blood of patients who have survived the infection and infuses it into those who are suffering with coronavirus.
“There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of Covid-19,” the NIH group said in a statement. “There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of Covid-19.”
The FDA granted emergency authorization on convalescent plasma on Aug. 23, one day before the Republican National Convention where Trump referred to the therapy as having the potential to “save thousands of lives.”
The NIH advisers’ report is only going to ratchet up the pressure on the FDA as it considers whether to approve other treatments and, eventually, vaccines.
Critical letter
On Monday, Eric Topol, the editor-in-chief of Medscape and a professor of molecular medicine at The Scripps Research Institute, published an open letter to Hahn calling on him to say why he misrepresented the plasma data or resign.
“We cannot entrust the health of 330 million Americans to a person who is subservient to President Trump’s whims, unprecedented promotion of unproven therapies, outrageous lies, and political motivations,” Topol wrote. “You have two choices to do the right thing. We cannot and will not rest until you make that choice.”
The topic was contentious even before the FDA’s authorization was issued. Trump said “deep state” staff members at the FDA were holding up the process for political purposes, while the New York Times reported that officials at the NIH urged their peers at the FDA to delay action until more definitive evidence was available.
Fauci denial
In an interview, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, denied that the new guidelines were a response to the FDA move. “The guidelines panel did not come out and criticize anyone or anything,” he said. “They were neutral” on using plasma in coronavirus patients.
FDA officials weren’t immediately available to comment.
Other industry insiders, including former FDA Commissioner Robert Califf, said the topic has created ongoing debate.
”If you just took random data and divided it into enough subgroups just by chance alone you would find differences,” Califf said in an interview. “It’s so enticing when you see it, but it really is just hypothesis. We don’t have definitive evidence one way or the other and we need to get it.”
Panel conclusion
The NIH’s Covid-19 Treatment Guidelines Panel said they reviewed published and unpublished data on convalescent plasma before issuing their recommendations, including the FDA analysis used to support the emergency authorization.
They concluded that there was no evidence that the therapy improved survival for all hospitalized patients, or for those who were hospitalized and relying on a ventilator.
Hospitalized patients who didn’t need mechanical breathing support saw a small benefit. About 11% those getting plasma with high levels of infection-fighting antibodies died within seven days, compared with 14% of those treated with lower levels of the antibodies. The statement didn’t say whether that difference was statistically significant, a sign that the results might hold up in a more rigorous study.
The data suggest that it may be beneficial for that subgroup of patients, though uncertainty remains about its safety and effectiveness, they wrote. Additionally, antibody levels in convalescent plasma vary widely and there isn’t an easy way to determine effective levels, they said.
“The long-term risks of treatment with Covid-19 convalescent plasma and whether its use attenuates the immune response to SARS-CoV-2, making patients more susceptible to reinfection, have not been evaluated,” the advisers said. “Convalescent plasma should not be considered standard of care for the treatment of patients with Covid-19.”
The emergency authorization was based on an expanded access program, in which everyone received convalescent plasma, not a clinical trial that compared one treatment to another. Careful trials comparing plasma to other Covid-19 treatments to see if patients getting plasma live longer or recover faster haven’t been completed yet. –Bloomberg
Also read: Trump’s plasma therapy push could delay clearer understanding of its science, some experts say
A law with actual teeth is needed against profiting from one’s employment in government, something like the starter measure taken by my home province’s (B.C.) NDP-Green government disallowing lobbying by former cabinet ministers and political staff for two years after leaving their jobs, from which they typically take valuable inside information that can enrich lobbying firms.
I’ve felt particularly strong about this since reading about the U.S. Food and Drug Administration commissioner, Arthur Hull Hayes Jr, who decades ago permitted the potentially health damaging artificial sweetener Aspartame to be placed in many foods and drinks, before he then left his FDA position for a lucrative job with the public relations firm owned by the Aspartame patent holder and producer, G.D. Searle Company.
This, despite being urged by credible health academics to refrain from immediately granting FDA approval of the sweetener—a chemical concoction discovered accidently in 1965 while G.D. Searle Company chemist James Schlatter was testing an anti-ulcer drug.
… BTW, my understanding of the original meaning of ‘Deep State’ is that it has to do with the fossil fuel industry’s insidious yet very effective lobbyist manipulation of governments big and small. Therefore, considering the Trump administration’s increased kowtowing to Big Fossil Fuel, far from genuinely wishing to drain it, the president seems quite content with wallowing in “the swamp”. (Frank Sterle Jr.)