Health Experts Say Convalescent Plasma Therapy Require More Studies

He alleged there are people at the FDA “that can see things being held up ... and that’s for political reasons”.

Dr. Joshua Sharfstein said the statement, and Hahn’s silence while Trump said it, “was disgraceful”.

“The FDA commissioner basically allowed the president to mischaracterize the decision and attack the integrity of FDA employees. I was horrified,” said Sharfstein, a vice dean at John Hopkins University’s school of public health who was a top FDA official during the Obama administration.

“This is a promising therapy that has not been fully established,” he said.

The push on Sunday came a day after Trump tweeted sharp criticism on the process to treat the virus, which has killed more than 175,000 Americans and imperiled his reelection chances.

The White House has sunk vast resources into an expedited process to develop a vaccine, and Trump aides have been banking on it being an “October surprise” that could help the president make up ground in the polls.

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“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted.

“Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

Earlier this month, Mayo Clinic researchers reported a strong hint that blood plasma from Covid-19 survivors helps other infected patients recover. But it wasn’t considered proof.

More than 70,000 patients in the US have been given convalescent plasma, a century-old approach to fend off flu and measles before vaccines.

It’s a go-to tactic when new diseases come along, and history suggests it works against some, but not all, infections.

The Mayo Clinic reported preliminary data from 35,000 coronavirus patients treated with plasma, and said there were fewer deaths among people given plasma within three days of diagnosis, and also among those given plasma containing the highest levels of virus-fighting antibodies.

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But it wasn’t a formal study. The patients were treated in different ways in hospitals around the country as part of an FDA program designed to speed access to the experimental therapy.

That “expanded access” program tracks what happens to the recipients, but it cannot prove the plasma — and not other care they received — was the real reason for improvement.

Administration officials, in a call with reporters Sunday, discussed a benefit for patients who were within three days of admission to a hospital and were not on a respirator, and were given ‘high-titer’ convalescent plasma containing higher concentrations of antibodies.

They were then compared to similar patients who were given lower-titer plasma. The findings suggest deaths were 35 percent lower in the high-titer group.

There’s been little data on how effective it is or whether it must be administered fairly early in an illness to make a significant difference, said Dr. William Schaffner, an infectious diseases expert at Vanderbilt University.

Aiming to ward off a possible run on convalescent plasma after the announcement, government officials have been working to obtain plasma and to team with corporate partners and nonprofit organizations to generate interest among previously infected patients to donate.