Harvard Epidemiologist Says FDA Is Blocking a Breakthrough COVID-19 Strategy

In a recent article in the Harvard Gazette, Michal Mina (assistant professor of epidemiology at Harvard’s T.H. Chan School of Public Health and Brigham and Women’s Hospital) explains why cheap, daily, do-it-yourself tests could be “as effective as a vaccine at interrupting coronavirus transmission.” He says a strategy based on the wide-spread use of such tests is “the only viable option for a quick return to an approximation of normal life,” and he bemoans the bureaucratic intransigency that is preventing its implementation. According to Mina:

Paper-strip tests have already been developed and their shotgun approach to testing — cheap and widespread — provides a way back to the workplace, classroom, and other venues.

The strategy, if adopted and backed by the federal government, could put hundreds of millions of tests in the hands of consumers within weeks, at a cost far less than repeated rounds of economic stimulus. …

Mina estimated that the nation’s current testing strategy probably catches less than 3 percent of cases early enough to affect whether a person transmits the virus. But as long as those testing positive stay home, a cheap, at-home testing regimen has the potential to provide a kind of artificial herd immunity, interrupting enough transmission nationwide to cause the pandemic to stall. …

The Food and Drug Administration, in charge of approving diagnostic tests, has held up approval because the tests aren’t as accurate as nasal-swab, lab-based tests. While that would matter if they were intended as an individual diagnostic tool, Mina said that from a public health viewpoint, they are accurate enough to provide critical initial screening on a large scale. Positive test results could be followed up by a visit to the doctor and a more accurate nasal swab test or, if illness weren’t that severe, by daily testing until a person is negative.

“Everyone says, ‘Why aren’t you doing this already?’ My answer is, ‘It is illegal to do this right now,’” Mina said. “Until the regulatory landscape changes, those companies have no reason to bring a product to market.” …

Though even a $1 per day test gets expensive if the federal government provides them free to all Americans, the cost would be far less than recent stimulus efforts, and even less than the effort to produce a vaccine, the urgency of whose development would ease if the testing regimen is effective.

“It will stop the vast majority of transmission and it will cause these outbreaks to disappear in a matter of weeks,” Mina said. “This is something we can actually do at warp speed.” [Emphasis added.]

Jon Guze / Director of Legal Studies

Jon Guze is the Director of Legal Studies at the John Locke Foundation. Before joining the John Locke Foundation, Jon practiced law in Durham, North Carolina for over twent...

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