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.”
Sadly, that is exactly how the FDA saw its role. Another lawsuit was filed, the FDA once again settled, and once again the government violated its agreement. The ban on rapid home HIV tests, despite being irrational and scientifically unjustified, lasted until 2012, when the FDA approved the first such test in the U.S., 16 years after it had approved the first mail-in test. During that period, more than 1 million Americans became infected with HIV.
Today, as Covid-19’s unrelenting assault on the U.S. continues, the FDA has expressed its openness to receiving applications for rapid home Covid-19 test kits. It’s reassuring that the FDA now recognizes the numerous benefits of allowing people to test without having to leave their homes. With a home test, people get results instantly, without having to risk exposing themselves or others at a testing site or wait days for lab results. If they’re positive, they can immediately seek medical guidance and take steps to prevent spreading infection.
But the political winds are blowing ominously against home testing. Some of the same justifications that were used against home HIV testing are surfacing in the press about Covid-19 testing: concerns that laypeople will misinterpret results unless they learn them from a doctor, that home tests will hamper critical surveillance efforts, and that the potential for false positive and false negative results outweigh the benefits of testing. These worries ignore the central reality that no test, whether taken in the home or sent to a lab, is infallible. There is always a need to educate people about a test’s limitations.
Some people will undoubtedly get false positive results and unnecessarily quarantine themselves. Others will get false negative results and may unknowingly spread the virus to others. Yet the benefits of testing far outweigh the risks.
Making a home test for Covid-19 widely available — and encouraging Americans to test frequently — can save lives.
With AIDS, the federal government brought its full force and power to fight the introduction of home HIV tests. With Covid, the government must instead mobilize its best and brightest — and the power of its purse — to make affordable, easy to use home tests a part of daily life until the pandemic ends.
History doesn’t repeat itself, but it often comes close. The lesson from the FDA’s unjustified 25-year ban on home HIV testing is one we should learn from, not repeat.
Elliott J. Millenson is the CEO of Global Diagnostic Systems, a company developing a rapid home Covid-19 test. He was the CEO of Direct Access Diagnostics which developed the first FDA-approved home HIV test. William A. Haseltine is the chair of ACCESS Health International.