Build a plan for Covid-19 home testing on reason, not speculation or politics

(Posted on Monday, November 16, 2020)

John Maynard Keynes once famously observed that there’s nothing as disastrous as a rational investment policy in an irrational world. But when it comes to public health, rational policies make sense even in an irrational or chaotic time like the midst of a severe pandemic.

When the government ignores rational health policy, and instead follows unsound ones, the effects can last longer than anyone expects. That’s what happened with the federal government’s unfounded resistance to home HIV testing, which cost millions of lives and trillions of dollars. We see similar resistance regarding home Covid-19 tests, which are being disparaged because they might not yield demographic data or might be misinterpreted. Putting up barriers to home testing would be disastrous.

In the 1980s, home testing for HIV also made sense. But we were ridiculed for believing that HIV, a sexually transmitted virus with a decade long period between infection and the onset of outward symptoms, could be transmitted heterosexually and become a pandemic. In meetings, federal health officials laughed at our idea that empowering people to test in the privacy of their homes for a sexually transmitted virus could dramatically reduce new infections.

Journalist Michael Fumento published a book, “The Myth of Heterosexual AIDS,” that attacked HIV researcher Robert Redfield (who now leads the Centers for Disease Control and Prevention) and one of us (W.H.) for suggesting that heterosexual individuals might be at risk for HIV/AIDS. A member of Congress attacked one of us (E.M.) as “unscrupulous and irresponsible” for proposing a home HIV test.

Independently, we both developed home HIV tests and both began the process of seeking regulatory approval. After receiving an application from one of us (E.M.), the first premarket approval application for a home HIV test submitted to the FDA, the agency in 1988 banned home HIV tests altogether. This was despite clinical trial data demonstrating that home HIV tests provided results identical to lab tests. It was also despite research that showed that one-third of people who wanted to test for HIV would only test with a home test, and two-thirds of Americans preferred the home test choice.

Even when the CDC’s own survey revealed that 29% of Americans would get tested for HIV if a home HIV test was available versus just 9% who intended to test using existing alternatives, both the FDA and CDC opposed home tests.

The public, trusting that the government was acting in their best interests, never caught on, and federal officials continued to insist that home tests were unsafe and unreliable. The data from clinical trials summarized in the 1987 submission for premarket approval of a home test unambiguously demonstrated safety and efficacy. But given the strong political pressure against home HIV testing — from labs, clinics, and initially from AIDS activists — instead of accepting the application for review, the FDA decided to ban even the consideration of home tests.

In banning home HIV testing, the government rejected the clarity of science for the fog of politics. The blame goes to the same reasons that financial markets act irrationally: lack of discipline, a failure to undertake fundamental analysis, and greed, the biggest culprit. Some labs and testing clinics feared the financial competition of affordable home tests. They aggressively lobbied against them, preferring to maintain their stake in the status quo rather than support public health.

Instead of standing up for what was scientifically and socially right, the FDA stacked the deck against home tests. When one of us (E.M.) challenged this ban in court in 1990, FDA settled, announcing an end to its ban and agreeing to hold an advisory committee meeting to review a home test kit application.

But the government violated its agreement. At the outset of the advisory committee meeting, the FDA simply announced that its ban was still in place. While the chair of the advisory committee (who ran a clinical laboratory) complemented the “marvelous job of making a very articulate presentation” one of us (E.M.) made, he then called the idea of considering the approval of a home HIV test “an exercise in absurdity.” One FDA adviser saw the situation clearly, stating, “It was almost as if this matter was brought before the FDA’s subcommittee on non-approvability. It did not occur to me that the agency was in the business of trying to protect existing suppliers from new products.”

Read the article on STAT News

Originally published on STAT News (November 16, 2020)