Friday, March 27, 2020

The Coronavirus Testing Debacle Stems From Decades of Bad FDA Policy

By Paul Detrick - March 27, 2020 at 08:45AM

The delay in COVID-19 testing in the United States meant that for weeks doctors and public officials were flying blind about who was infected and where major outbreaks were located. This means that they had little hope of containing the virus before it started spreading out of control.

Why did the U.S. fall behind almost every other country in this regard?

The root of the problem is the Food and Drug Administration's (FDA) culture of extreme caution, which led to needless suffering and loss of life long before the coronavirus pandemic. In this case, its impact is so high profile and far-reaching that the episode could finally bring lasting reform.

The genetic sequence for COVID-19 was published on January 10th by Chinese scientists and uploaded to the National Institute of Health's website, allowing laboratories around the world to create their own diagnostic tests.

German scientists had one within the week, and other countries and private labs quickly followed suit. The World Health Organization shipped 250,000 German-made tests to labs around the world.

The U.S. Centers for Disease Control (CDC) decided it needed to rely on its own version of the test, which could be certified by the FDA, but it wasn't ready until early February.

On February 6 and 7, 90 tests were shipped to state public health labs around the country, but the kits had a technical flaw and needed to be returned to the CDC for testing.

Meanwhile, the virus continued spreading.

On February 4, the FDA said it would allow government-approved labs with high complexity testing capabilities to create their own tests, provided they copy the CDC's approach and send all of their results to the agency's headquarters in Atlanta for verification. 

As former FDA Principal Deputy Commissioner Joshua Sharfstein told The New Yorker: "You certainly wouldn't want to say, 'Any lab can advertise a coronavirus test.' Because then it's going to be chaos. There are a lot of people who will sell things that may or may not work."

Though well-intentioned, the rule became a stumbling block.

Take the case of Alex Greninger, a doctor and researcher at the University of Washington, who, according to a report in GQ, submitted his application to create a coronavirus test via email. Then he learned that he also needed to submit a paper copy, and then another version burned to a compact disk or loaded onto a drive and delivered to the FDA's Maryland headquarters.

After he complied, the FDA did not approve his test right away, according to a report in ProPublica. They asked him to make sure his test didn't cross-diagnose with SARS and MERS, other coronaviruses which hadn't been seen in the U.S. in years. His test was finally certified on February 29, at which point the fatal outbreak in his home state of Washington was already underway. 

As the crisis worsened and the testing shortage drew headlines, the FDA simplified the process. But then on March 20, it shut down efforts to rapidly make available at-home testing kits on the grounds that they were unvetted and could be fraudulent.

The first documented cases of COVID-19 in the U.S. and South Korea were discovered around the same time. Yet, as of March 17, 1 out of 4,300 Americans had been tested. In South Korea, it was 1 out of 17. Had diagnostic tests for COVID-19 been available sooner, they would have helped public health officials isolate, quarantine, and provide medical supplies to areas of the U.S. affected by the virus.

How could this happen? This tragic testing delay has brought national attention to the FDA's longstanding, overly cautious approach to regulating American health care. To minimize risk, the agency has sacrificed speed—preventing doctors and patients from accessing the tools they need—until it's too late.

The agency's risk reduction over speed of approval goes back to the 1960s, when a sleeping pill called thalidomide marketed to pregnant women for nausea caused babies to die in utero or to be born with serious birth defects. The crisis was mostly contained to Europe because concerned FDA regulators had kept the untested drug out of the U.S.

In 1962, President Kennedy signed a landmark bill increasing the agency's oversight powers. It resulted in a culture of extreme caution that led to long approval times for experimental drugs and devices, keeping potentially life-saving tools out of the hands of patients.

The beginning of the movement to relax those rules, and rethink the tradeoff between risk and speed in the FDA approval process, began during the AIDS crisis of the 1980s. Gay rights activists were outraged that the FDA wouldn't quickly approve more experimental drugs like AZT, which blocks HIV's replication, or thalidomide, which could be used to treat some of the symptoms of AIDS.

After lobbying and protests, including the 1988 shutdown of the FDA building, the administration slowly began to loosen its rules, leading to the approval of highly active antiretroviral therapy or HAART in 1996. Because of HAART, contracting HIV wasn't a death sentence anymore.

Gay rights activism during the 1980s and 1990s created a framework for patient advocacy for people with life-threatening illnesses, leading to the Right to Try movement, which has allowed terminally ill patients to access experimental drugs and devices that are still undergoing FDA testing. 

The movement pushed the agency to streamline its own compassionate use program to help the same kinds of patients.

But the COVID-19 testing debacle underscores the limits of those reforms. Once a full investigation comes out about the agency's failures, perhaps it will finally bring fundamental reform, at last giving Americans rapid access to potentially life-saving tools.

Produced and edited by Paul Detrick.

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