Following critical commentary from a range of medical authorities, U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn issued an apology on Tuesday for an earlier statement exaggerating the potential life-saving attributes of convalescent plasma treatment for those suffering from the novel coronavirus.
On Sunday, President Donald Trump indicated that the FDA had determined that it would issue emergency authorization for the use of plasma extracted from patients already recovered from COVID-19 as a treatment for individuals currently infected with the virus. Trump touted plasma treatment as a groudbreaking milestone in the fight against the coronavirus. This announcement prompted notable pushback from scientists and health professionals who cast doubt on the accuracy of the claims Hahn used to support the administration’s decision.Read More »
The specific claim in question suggested that at least 35 out of 100 coronavirus patients treated with convalescent plasma would survive their bout with the condition, though critics argue that this is a substantial overstatement of what the Mayo Clinic actually found in the study at issue. As such, Hahn faced calls from the scientific community to make a public clarification.
In addressing the situation, Hahn acknowledged the deluge of criticism directed toward the administration since Sunday and said, “the criticism is entirely justified.” He further admitted that it would have been more accurate to say that the Mayo Clinic data hinted at a relative reduction of risk for coronavirus patients, not an absolute reduction of risk.
The benefits cited by the Trump administration were taken from findings of a yet-to-be-published study of COVID-19 patients who were given blood plasma donated by previously infected individuals. This is a process that has been effective in treating other types of conditions, but issues with the methodology in this particular study and the fact that it has not been peer reviewed have led critics to question the administration’s assertions in reliance on it.
Many of those who have slammed Hahn for his statement on plasma treatment for coronavirus patients remain dissatisfied with his mea culpa. Dr. Eric Topol of the Scripps Translational Research Institute, for one, demanded that the administration hold a public press conference to correct misconceptions and change information presented on the FDA’s website as a means to “restore public trust,” as NPR reported.
The concept of using convalescent plasma to treat sick patients is not new, and it has been used for decades to address a whole family of other illnesses including the flu and other viral infections. However, in the context of COVID-19, more evidence is needed to determine whether the strategy is indeed effective and what type of dosage is required to achieve optimal effect.
While the emergency authorization issued by the FDA to permit use of this treatment in coronavirus patients is likely to broaden availability nationwide, some are concerned that this will hamper the ability of researchers to truly determine whether it works, because most studies rely on randomized use of the treatment and placebos in study populations.
Critics of the administration argue that episodes such as this one serve to undermine the FDA’s credibility at a most critical time. With coronavirus vaccine trials and approval processes ongoing, they suggest that it is more important than ever for Americans to have faith in the statistics and efficacy claims cited by the agency and suggest that Hahn signing onto Trump’s assertion like he did only harms the overall cause.
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