This article was first published in Statnews – Elliott Millenson was the founder and CEO of the Johnson & Johnson company that developed the first home test for HIV.
As the government struggles to help Americans move from lockdowns and shelter-in-place orders to a “new normal,” home testing for Covid-19 needs to be an important part of whatever plan emerges.
The home test that’s needed is a rapid, highly effective combination antigen-antibody test with embedded technology to enable seamless, confidential contact tracing. The antigen assay would let users know if they are currently infected with SARS-CoV-2, the virus that causes Covid-19. The antibody assay would tell them if they had been infected in the past, possibly without knowing it.
The technology for creating rapid home combination tests is well-established. And contact tracing can be added quickly by adopting existing technology. America has the most innovative health care companies, ingenious technology companies, and strongest medical and academic centers in the world. There is no doubt they can produce the home test our nation needs.
For the implementation of any home Covid-19 testing strategy to work, however, the government must focus on science and data over politics.
It is essential that all tests be validated before they are allowed on the market. Sadly, the Food and Drug Administration has broken with its mandate of making decisions informed by this sort of data for Covid-19 testing. Instead, under its Emergency Use Authorization, the FDA has allowed any and all suppliers of Covid-19 tests to sell them without providing any performance data.
Now that it is becoming clear that some of these tests aren’t working well, the FDA is engaged in what appears to be a bit of obfuscation. At the White House’s daily afternoon briefing on Tuesday, FDA Commissioner Stephen Hahn claimed that companies have done “self-validation” of their tests (which made me recall the time in third grade I self-graded my history test).
This decision by the FDA has resulted in the use of tests that are not even close to being 95% reliable, according to a recent performance study. With a highly contagious disease like Covid-19, a test that tells some individuals they are negative for the virus when, in fact, they are infected with it can have dire consequences.
The FDA’s reckless and dangerous policy of allowing tests on the market without requiring validation was undoubtedly based on political pressure. Tragically, it’s not the first time FDA has put politics over science in the face of an epidemic.
In 1987, a company I founded applied to the FDA to approve the first home HIV test. Clinical trials that included more than 5,000 participants showed that it provided results that were 100% concordant with the best lab tests. There was a clear need for this product: At the time, one-third of Americans who wanted to test for HIV would only do so with a home test. Yet there was opposition to home HIV testing from laboratories, clinics, and even AIDS activists, all of whom had a stake in the testing status quo.
So even though HIV was incurable — and outwardly asymptomatic for 10 years or so after infection — the FDA instituted a ban on home HIV testing that lasted for the next 25 years. It wasn’t until 2012 that FDA approved the first rapid home testing kit for HIV. And following the FDA’s lead, the World Health Organization didn’t endorse home testing until 2018.
Even today, there is no broad-scale HIV testing program, despite the fact that 1.3 million people worldwide are newly infected with HIV each year, 40,000 of them in the U.S., and AIDS spending accounts for more than 1% of U.S. federal tax receipts.
The lesson learned from the U.S. government’s opposition to home HIV testing is that politics can trump common sense, science, and the public good. As Mark Twain once observed, “It is not worthwhile to try to keep history from repeating itself, for man’s character will always make the preventing of the repetitions impossible.” Translation: Since the character of those in government is to focus on politics, it’s up to the American people to demand that government supports the widespread distribution of home tests — and makes sure they work.
While competition to develop and validate home Covid-19 tests will likely yield better, more effective, and less expensive products, industry must work cooperatively once the FDA has approved the most effective tests. Production details should be shared among a consortium of capable manufacturers with the experience and resources to make or buy the necessary components to scale up production and distribution of tens of millions of high-quality, low-cost Covid-19 tests weekly to the U.S. and the world.
Robert Frost wrote of two roads diverging in a wood and taking the one less traveled. Even in the midst of an epidemic, America is as divided politically today as it has ever been. In this environment, the road less traveled is the one that takes us to look outside government for solutions to the Covid-19 epidemic. Ages and ages hence, as Frost wrote, that will make all the difference.