Most COVID-19-related EUAs Lack Strong Supporting Evidence, JAMA Article Says
High-quality evidence was lacking for most of the COVID-19 diagnostics, medical devices and drugs the FDA has granted Emergency Use Authorization (EUA) since the start of the pandemic, claimed researchers at Israel’s Tel-Aviv University in a provocative analysis in the journal JAMA Internal Medicine.
The researchers based their conclusion on 393 products for which the FDA granted EUAs for COVID-19-related purposes, including 329 diagnostic tests, 54 medical devices and 10 drugs or vaccines.
“The EUAs for diagnostic products were mostly supported by comparisons with various previously authorized assays” — 77 percent of the 254 diagnostics authorized — noted co-authors Itay Moshkovits and Daniel Shepshelovich. Most of the remainder, 47 diagnostics or 14 percent, were supported by in vitro studies.
“Because these diagnostic products were not tested against criterion standard and no evaluation showed that the products correctly identified people with vs. without COVID-19 infection, the true sensitivity and specificity as well as real-world frequency of false-positive and false-negative results can only be approximated,” they claimed.
Although it was “reasonable” for the FDA to grant the EUAs in this context, they argued that “in future public health emergencies, the FDA should consider raising the standard of evidence required for EUAs after several diagnostic products are marketed to ensure their accuracy.”
“No supporting evidence was specified” for 32 of the 54 medical devices, they said. And in another 20 cases, or 37 percent of the device total, only laboratory data were supplied. “Lack of evidence might bring to market devices that are potentially more harmful than beneficial,” they argued.
The supporting evidence was stronger for drugs and vaccines, with seven out of the 10 EUAs supported by randomized clinical trials.
The FDA revoked EUAs for 17 products — two drugs, seven devices and eight in vitro diagnostics. In 10 cases, this was because of problems with effectiveness or safety. Most notoriously, the FDA granted and then swiftly revoked an EUA for chloroquine/hydroxychloroquine (FDAnews, Nov. 19, 2020).
“Regulators should resist political pressure to authorize products that are not supported by high-quality clinical data. Doing so might prevent confusion and mistrust in the soundness of medical science and bolster the FDA’s reputation,” the authors said.
The FDA did not respond to a request for comment by press time.
Access the JAMA Internal Medicine article here: bit.ly/3plXuXD. — Martin Berman-Gorvine