Many Americans are wondering why public health officials are not doing more to speed up deployment of coronavirus testing kits. What would happen if a private team of doctors offered an effective test before federal regulators approved one?
Dr. Helen Y. Chu and a team of infectious disease experts in Seattle found out the answer: The government will stop you.
According to a New York Times investigation, Dr. Chu and a team of researchers in the Seattle area had been collecting nasal swabs from residents experiencing symptoms in an effort to monitor the spread of flu in the region. It turned out they could use their test to monitor the coronavirus outbreak, but they would need approval from state and federal officials to do so legally.
“But nearly everywhere Dr. Chu turned, officials repeatedly rejected the idea,” the Times investigation shows, even though it was clear that the virus was already ravaging China and likely to spread in the US. She and her team decided to start performing coronavirus tests without government approval anyway. Their worst fears were confirmed as they were able to document that a local teenager had the virus. Government officials later confirmed the findings from Dr. Chu’s team. According to Times reporters Sheri Fink and Mike Baker, however, regulators still would not allow her team to move forward with more testing:
“Federal and state officials said the flu study could not be repurposed because it did not have explicit permission from research subjects; the labs were also not certified for clinical work. While acknowledging the ethical questions, Dr. Chu and others argued there should be more flexibility in an emergency during which so many lives could be lost. On Monday night, state regulators told them to stop testing altogether.”
Fink and Baker note that the government’s failure to allow this study to go forward, “was just one in a series of missed chances by the federal government to ensure more widespread testing during the early days of the outbreak, when containment would have been easier.” Sadly, matters are not improving. “The continued delays [in getting government-approved testing kits] have made it impossible for officials to get a true picture of the scale of the growing outbreak,” the reporters note. Meanwhile, early government-approved diagnostic tests were contaminated, meaning the Seattle test should have been welcomed as an alternative. The journalists conclude that:
“the Seattle Flu Study illustrates how existing regulations and red tape — sometimes designed to protect privacy and health — have impeded the rapid rollout of testing nationally, while other countries ramped up much earlier and faster. Faced with a public health emergency on a scale potentially not seen in a century, the United States has not responded nimbly.”
Needless to say, this is a public health catastrophe in the making. Overly precautionary regulations may have undermined public health and cost lives.
Red Tape vs. Public Health
Officials at the Centers for Disease Control and Prevention and the Food and Drug Administration say they are working aggressively to come up with better testing procedures to counter the virus, which has now been classified as a pandemic by the World Health Organization. Even if it is true that federal officials are trying their hardest to speed up testing, the government’s rejection of the Seattle Flu Study testing effort represents a disturbing example of the failure of good intentions in action. Just because precautionary-minded regulators say they have our best interests in mind, it does not necessarily mean their policies actually serve the public good.
In this case, highly restrictive procedures for virus testing have had the unintended consequence of shutting down tests that could detect outbreaks and save lives. Going by the book apparently mattered more than getting good results. “This virus is faster than the FDA,” a University of Washington Medical Center doctor told the Times. Incredibly, that doctor also said that at one point the agency was asking him to submit materials through the mail in addition to over email. Strict regulatory paperwork procedures have triumphed over common sense.
Incidentally, the Seattle Flu Study team is funded by the Bill & Melinda Gates Foundation, and health officials from the Foundation and from the state of Washington petitioned the CDC to consider using the Seattle team’s test results. The CDC simply punted on the issue and told them to seek FDA approval. The Seattle Flu Study did not strictly comply with established CDC and FDA lab regulations, however, and so the answer from federal regulators was always came back the same: No. “We felt like we were sitting, waiting for the pandemic to emerge,” Dr. Chu told the Times. “We could help. We couldn’t do anything.”
The Ethics of Evasion
However, what is most interesting about this example of innovation-limiting regulation is that it did not stop Dr. Chu and her team from moving forward, at least not initially. Instead, they engaged in what we might think of as “evasive entrepreneurialism” or “technological civil disobedience.” They went ahead and tested for the coronavirus without permission to prove that they might be able to help. Stated differently, they broke the law in pursuit of a higher goal.
What are we to make of the ethics of that decision? It is a thorny question and one that I discuss in a forthcoming book, which documents the rise of evasive entrepreneurialism and technological civil disobedience in many different contexts. Evasive entrepreneurs are innovators who do not always conform to social or legal norms. They take advantage of new devices, platforms, and methods of production to experiment with new ways of doing things. Sometimes they do so intentionally to evade laws or regulations they find offensive, confusing, or counter-productive. That’s why I refer to it as technological civil disobedience.
Dr. Chu’s evasive act of testing-without-approval tees up the core ethical and legal question raised repeatedly in my new book: Why is it that many people often justify acts of evasive entrepreneurialism after the fact, but few defend them as they are happening? Stated differently, why are people (including the New York Times of all papers) cheering on Dr. Helen Chu and her team right now instead of suggesting they be fined or sent to jail? After all, technically speaking, they broke the law. Some will say she and her team can be forgiven because their evasive actions could help save lives and, therefore, the ends justified the means. But who would have stood by her and her team when they initially set out to innovate around the system to achieve that result?
The answer in this and many other instances is not black-and-white. But evasive innovation could clearly help save lives in this case, which must have some bearing on the moral calculus here.
Putting the Genie Back in the Bottle
But let’s consider the case against evasive entrepreneurialism in this context. To be sure, the ethics of medical testing are extraordinarily complicated. At the individual level, there are serious concerns about patient medical privacy. In the aggregate, there are legitimate questions about what types of tests can be trusted as well as concerns about mistaken results fueling panics or misguided treatments.
But even putting those ethical questions aside, this case raises a more practical reality: New technological capabilities—in the medical space and others—are becoming more decentralized and democratized.
In the old days, “doing science” was exclusively the domain of experts in big institutions. Going by the book was more straightforward in that environment. Things get more complicated once the genie is out of the bottle and more institutions and individuals have access to technologies that allow more decentralized forms of trial-and-error experimentation.
Risk-averse regulators and their highly precautionary mountains of red tape can only stand in the way of so much of this. Policymakers will need a new approach for technological governance in this new world. Flexibility and humility will be essential. Regulators should not throw out the old rulebooks altogether, of course. Some precautionary procedures still make sense. Not everyone should be running their own lab or doing their own tests. Permissionless innovation has its limits.
On the other hand, lawmakers and regulators could borrow a page from the permissionless innovation playbook and allow more experimental trials, flexible testing procedures, targeted waivers, and ex post regulatory reviews as opposed to ex ante regulatory prohibitions on any and all innovations.
Evasive entrepreneurialism should be thought of as an important part of a broader discovery process that appreciates the profound importance of ongoing, decentralized trial-and-error experimentation to the process of social learning. Lawmakers should find a way to accommodate a little more outside-the-box thinking and innovating, especially when our lives are on the line.