The COVID-19 pandemic has brought about an unprecedented use of the word “unprecedented,” especially when it comes to tests and treatments and getting those products to market.
The Food and Drug Administration relied in part on trust to spur innovation that could combat the pandemic as it gave labs and manufacturers of COVID-19 tests “unprecedented” flexibility. Producers looking to meet “unprecedented” demand were told they could sell tests as long as they validated them internally and filed for FDA emergency use authorization within 15 days.
Shortly after came complaints of scams and unreliable tests.
On May 21, the FDA posted a list of 28 COVID-19 antibody tests that should never see the light of day. These products were either voluntarily withdrawn by their manufacturers, or those companies failed to pursue the needed federal approval to go to market.
“We have seen a high level of collaboration and engagement from developers who want to get this right, and we continue to be available to work extensively with industry to help them with developing accurate tests for the public,” FDA Commissioner Dr. Stephen M. Hahn said when the list was released.
After government and public health officials said serological tests would be key to reopening the country, countless companies entered the game, hoping to reap big rewards. Congress allocated $25 billion for all COVID-19 testing. Meanwhile, job loss is nearing an all-time high.
As we inch toward some semblance of normal and depend on every option to keep us safe, the Centers for Disease Control and Prevention said antibody tests used to detect if people have been infected in the past with COVID-19 might be wrong up to half the time. They aren’t accurate enough to use in making important policy decisions, the CDC warns.
Sure, there are 67 serological test makers (as of deadline) still in production, but the public is being asked to trust technology that’s regulated by a 78-word document. That detail was recently pointed out by a former test producer and whistleblower, Tyler Schultz, who worked with a Wall Street Journal reporter to reveal problems at biotech startup Theranos.
Theranos promised it could deliver faster, more accurate and cheaper results than traditional blood-testing systems. Schultz recently wrote that the “wild west” of largely unregulated test production helped his former boss, Elizabeth Holmes, briefly become the nation’s first self-made female billionaire.
Holmes, like the COVID-19 serological test developers, used the emergency authorization process to get approval for Theranos’ miniLab.
Schultz, who now runs his own blood testing company, remarked how the current validation requirements for SARS-CoV-2 were “remarkably relaxed” and that labs can test patients without validating results in real world circumstances. That explicit trust plus the lack of regulatory oversight was Theranos’ “bread and butter,” Schultz wrote.
Scott Becker, CEO of the Association of Public Health Laboratories, lauded the FDA when it reversed its lax policy on serology tests in May. Producers now have 10, not 15, days to submit data and must seek emergency use authorization.
“We’ve long been concerned that allowing tests on the market that have not been approved and authorized for use is a recipe for disaster,” Becker said. “This revised policy … should have been in place over the last six weeks.”
The FDA however, only “recommended,” but did not require sensitivity and specificity thresholds.
Federal regulators need to stop relying on trust that is so often abused in the face of enormous profits. Instead they should require rigorous, albeit streamlined and accelerated, vetting.
Theranos showed that we can’t trust manufacturers to provide data that will prevent them from staying in business. We may be reminded of this in great detail come August when Holmes and an associate stand trial. By that point, we should easily be able to see whether the pandemic resulted in any new bad actors; only this time the stakes are much higher.