Out of the Way, FDA

I n the course of my scientific activities, I have met a lot of interesting people. One of the most outstanding is the very eminent biologist Steve Benner. I know Benner because of his involvement in the space program, but he is also the founder and president of Firebird Diagnostics, a company that has developed and marketed rapid-turnaround tests for mosquito- and tick-borne viruses, giving results in 15 or 20 minutes. He has now developed one for Covid-19.

Benner’s coronavirus test is currently being used in India, a country that, despite having four times America’s population and much more unfavorable living conditions, has one quarter of our coronavirus death toll. But it is not being used in the U.S.A.

I lead a small aerospace research-and-development company. I would like to improve the safety of my employees. So when I heard about Firebird’s test, I contacted Benner. Would it be practical to use his technology to test my whole work force, say once a week? It wouldn’t be foolproof protection; someone might get infected the day after they were tested. But if we had a procedure in place that might catch asymptomatic cases and send them home before they spread the virus to anyone else, that, added to our masks and social-distancing practices, could only serve to make everyone safer. Would it be doable?

The answer was yes. Very modest training in the right procedures would be needed. The test requires only a mouth swab, which is then dropped into a test tube containing the solution. The presence of coronavirus at levels as low as 1,000 viruses per several-milligram sample would be revealed by a color change in the testing solution. Any active Covid-19 cases would have millions of viruses per swab. We could test everyone when they showed up for work on Monday morning, detect any probable cases, and send any suspects home by 9:00 a.m. The cost to me, including the testing ingredients and consultation with Benner’s experts, would be about $40 per test. That’s nothing compared to the $1,000 to $2,000 per week salaries of my employees — or the losses I would incur if the virus forced me to shut down. I was all in.

But we had to call it off. Looking into the regulations, Benner’s legal staff determined that since his test is not yet approved by the FDA, he could face criminal prosecution if he sent diagnostic materials across state lines.

What is the alternative? I could send employees to a state testing center. In Colorado, such services are available for free. But they take two weeks to return results, making them useless. The bottom line: I can’t institute an effective testing program because of the FDA.

This doesn’t just affect me. The entire nation is suffering from this problem. At 1,000 deaths per day, the nation is currently enduring three times the death rate we suffered in World War II. With tests such as Benner’s we could test the whole national work force every week, quarantine the infected, release the uninfected, and end the pandemic within two months. Currently 11 percent of the U.S. labor force is unemployed. If 0.5 percent drawn from those out of work were hired to test all 100 percent of the workforce, they would only have to each test 40 people per day in order to test everyone every 5 days. The cost would be substantial in absolute terms, but trivial compared with what we are now shelling out in relief payments, economic dislocation, medical bills, suffering, and deaths.

There is only one thing stopping such an effective program from being implemented, whether at the federal, state, local, company, or individual level. That is the obstinacy of the FDA.

Obtaining FDA approval is impossible for an innovative small biotech company such as Firebird with limited capital. The Firebird test was easily proven with simulated samples. It gives essentially no false positives or false negatives.

However, the FDA requires real patient samples. These must include patients who are sick, patients who are asymptomatic carriers, and patients who are negative. Patients who are negative are easy to find. Patients who are sick cost tens of thousands of dollars to find, but they can be found. Patients who are asymptomatic carriers, however, cannot be found except by accident.

Even if the resources are available to run a trial, such local tests have difficulty being FDA-approved for asymptomatic carriers. The FDA requires that workplace tests give the same result as highly sensitive “gold standard” tests based on the polymerase chain reaction (PCR). But PCR detects minuscule amounts of virus, as few as ten per sample. Local tests cannot match this sensitivity without adding preparation steps, expert users, and expensive instruments. This defeats their value.

But high sensitivity is not needed in a local test to give it value. As Benner explains, “Covid-positive patients with low viral load are unlikely to transmit their infection to others, especially when masks and distancing are used.”

The FDA is treating Covid-19 as it treats HIV, where a single virus indicates an infection requiring medical action. The FDA has not adjusted its inflexible demands to meet the public need regarding this pandemic at this time. So the pandemic continues with the best tools for fighting it off the table.

By shutting out the most valuable tests, the FDA is effectively disarming America in its life-and-death struggle with the virus.  The FDA regulations do not consider the possibility that a test less sensitive than the “gold standard” might be preferred in public health, sacrificing unnecessary sensitivity to get necessary on-site speed. But speed is what we need.

False positives can always be eliminated by retesting, so that is not an issue. The FDA says, however, that it doesn’t want to “risk” tests that could produce false negatives. But by preventing mass testing, the FDA is effectively producing universal false negatives.

It any case, risk is best understood by those who actually face it. That means those of us who are trying to keep our workplaces safe, not those who are trying to show they followed standard procedures.

The coronavirus epidemic is a five-alarm fire.  Effective action is long overdue. The FDA needs to get out of the way.