In its fight to prevent the spread of the coronavirus, the government must recognize that, as our nation’s top infectious disease expert admitted recently, the U.S. testing system is “failing.”
To fix it, the government must take immediate action that includes developing and broadly distributing “direct access” test kits so that people can test early and often. Direct access test kits enable people to collect a specimen at home and send it to a lab for testing. Results and medical guidance are available by phone.
In the 1980s, I developed the first such test for HIV. One-third of the public said it was the only way they’d test for HIV. The technology for collecting specimens is proven. People can easily and safely collect their own specimens and send them for testing.
A key advantage of this approach is that it can be scaled quickly — tests can be distributed broadly, and specimens can be sent to a central location (the FedEx Memphis hub for example) where they are shipped to laboratories for testing. Results can be obtained by calling a central test result center using a unique code number on each kit. If results are positive, callers can be referred to appropriate care.
This centralized approach ensures that specimens can be distributed efficiently according to each lab’s capacity to test — thus maximizing the number of people tested. With drive-up testing, there are reports already of a Colorado facility with hourslong lines for testing. Having people who are potentially ill waiting in long lines in cars with no food, water, or bathrooms (potentially with uninfected people also in the car) is not optimal.
Broadly distributing tests to the public is not just a way to get infected people into treatment. Many infected people will only exhibit mild symptoms. By taking a test, they can take steps to minimize their social interactions to prevent spreading the virus to others. Likewise, the Centers for Disease Control and Prevention has recommended that those who are most at risk of infection should “keep away from others” when they go out in public and “avoid crowds as much as possible.” By taking a home test, those who are at risk can take a test without leaving home, limiting their exposure to others.
With HIV, the Food and Drug Administration responded to my home test application by banning such tests because the CDC, AIDS activists, and others with an interest in preserving the status quo opposed their use for political reasons. The ban lasted 25 years — even as almost 2 million Americans became infected with HIV. With coronavirus testing, the CDC and FDA should encourage partners like FedEx, Roche, and LabCorp to work together to develop and distribute a direct access test.
Government and private companies are now working on a coronavirus vaccine. Yet there is still no vaccine for the common cold, which is caused by coronaviruses, and despite decades of hopeful comments from the National Institutes of Health, there is still no AIDS vaccine. However, there appears to be hope for a COVID-19 vaccine. One way to streamline the vaccine approval process would be to plan for a two-pronged approach, namely going forward with distributing the most promising vaccine to those most at risk after safety trials are completed but before efficacy trials, which can take significantly longer, have ended. Efficacy trials must still proceed on a parallel path. However, we can’t let the perfect be the enemy of the good.
The government has an important role to play in preventing as much suffering from COVID-19 as possible. It will require a creative, bold approach. During the height of the AIDS epidemic, former Surgeon General C. Everett Koop implored the FDA, unsuccessfully, to drop its ban on home HIV testing. “Testing,” Dr. Koop said, “is all we have, and therefore testing is what we must do.”
This time can be different. We must now form public-private partnerships to expand testing, develop treatments, and bring the most promising vaccine to the public as soon as practical. We cannot always prevent world-active viral events along the lines of HIV. But we can and must do all we can to limit their damage.
Elliott Millenson pioneered the development of direct access tests with a test for HIV in the 1980s.
