Precaution and the Pandemic — Part I

In this time of pandemic, we are learning about our government in real time – its strengths and weaknesses; the variety of its responses; and about our relationship, as citizens, to those we have elected to serve us. Most importantly and most immediately, we have learned the necessity of having a competent, expert regulatory structure largely immune from partisan politics even in these times of concern, anxiety, and confusion.

One of life’s lessons that most of us have learned, most likely from our mothers, is that it is better to be safe than sorry. That bit of folk wisdom has been embedded in environmental law for about three decades, where it is known as the precautionary principle. Briefly, that principle can be explained this way: “Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.”

To be sure, the principal has its advocates and critics, and, unsurprisingly, it has been highly politicized. However, the principle is not new, and it is embedded in many of the laws we use to regulate potential hazards. Most significantly for today and for our concerns about coronavirus, consider our food and drug laws.

Before a new drug or medical device is placed on the market, the U.S. Food and Drug Administration (FDA) tests it to determine if it is safe and effective for human consumption and use. This commonsense test is intentionally cautious and is an excellent example of the precautionary principle. The AIDS era of the 1980s and ’90s tested the precautionary principle as persons faced with life-threatening diseases wanted to forgo it by taking unproven drugs that they hoped would save their lives. The FDA responded in part by first advising caution and then revising its rules to allow for expedited review in some instances. Throughout, however, it retained its “safe and efficacious” standards.

Precaution, though, comes in two different varieties. The first is the ordinary understanding of precaution that manifests itself as a wait-and-see approach to governing. During the AIDS epidemic, the federal government used precaution and waited for scientific evidence before putting new drugs on the market, although the FDA did eventually allow doctors to prescribe certain medications for "compassionate use" by patients in an advanced state of AIDS. Currently, we will need the FDA to exercise its expertise and caution when coronavirus vaccines and other drugs become available.

There are several dangers of prematurely deploying vaccines, drugs, and medical supplies.

• One danger is when drugs are, in fact, harmful, which can lead to further illnesses and fatalities.
• Another danger is that these supplies are ineffective; they simply do not work. Again, even if no injuries or fatalities occur, it is likely that people will undertake higher risks under the belief that medical relief is available when it is not.
• An additional danger is that useless or dangerous medical supplies are sold to the public unnecessarily. In short, suppliers will profit, likely through price gouging, at the expense of consumers. False hope may sound like a harmless placebo, but it comes with real costs.

Fortunately, the FDA has taken crucial and important steps thus far that demonstrate the second dimension of the precautionary principle: Take aggressive preventive measures when warranted, and do not wait for a cost justification or for things to turn around on their own or as a result of other measures.

This second type of precaution, aggressive public health actions, has been in evidence, albeit in varying degrees, at the federal, state, and local levels. At the federal level, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health have put forward a consistent public message about the health risk of the virus and about the proper public health responses.

The FDA, too, has acted by accelerating reviews and licensing for medical equipment and pharmaceuticals and authorizing state laboratories to grant regulatory approval for testing and other treatments so that necessary supplies are deployed more quickly and widely.

At the state level, governors such as Mike DeWine (R-OH), Andrew Cuomo (D-NY), Larry Hogan (R-MD), Gavin Newsom (D-CA), J.B. Pritzker (D-IL), and Tony Evers (D-WI) closed restaurants and bars, cancelled public events such as sports and the arts, mandated self-quarantine, and required state residents to stay home except to exercise and purchase essentials such as food, medicine, and supplies needed to work from home. It is a depressing and regrettable reality, however, that governors have divided along partisan lines, with many Republican governors sluggishly or only partially adapting to the harsh realities of this virus and slow-walking necessary precautionary public health steps.

At the local level, mayors such Keisha Lance Bottoms (D-Atlanta) and Francis Suarez (R-Miami) have imposed stay-at-home orders for their cities and argued for stronger state-level protections in opposition to their governors. Unfortunately and inexplicably, Arizona Governor Doug Ducey (R) has gone so far as to restrict local mayors, such as Kate Gallego (D) of Phoenix, from exercising public health measures. Mississippi Governor Tate Reeves (R) also overrode local jurisdictions' restrictions, issuing in their place a series of half-a-loaf measures.

While it is, of course, too early to write the history of the coronavirus and the government’s response to it, three lessons are apparent. The first comes from some federal officials, as well as state and local government leaders, who took the proactive measures listed above. Most notably those precautionary decisions were based on the expert advice of public health and medical personnel and on the available scientific evidence.

Second, at the federal level, seasoned bureaucrats played an important role in shaping the federal response and informing the public.

Third, and regrettably, political leadership at the top of federal agencies and in the White House demonstrated a lack of urgency, put out conflicting medical messages and projections, and may very well have misguided Americans at a significant cost to public health. Even as I type these words, Americans are receiving a bulk-mailing postcard from the White House that offers "President Trump's Coronavirus Guidelines for America" – advice that has long since been overtaken by stay-at-home orders issued in the two weeks since it was written.

The White House's behavior has been particularly egregious. Misinformation, distortions, and outright falsehoods were followed by denials and contradictions throughout March. Until late in the month, it was politics as usual for President Trump. The White House minimized the danger of the coronavirus as he propped himself up, tried to soothe markets and his base instead of accurately informing the public, criticized journalists and news outlets for asking questions about the erratic federal response, and attacked perceived political enemies rather than addressing the nation straightforwardly and responsibly. At the end of March, expert advice was apparently finally heard, and the president began to reverse himself about the seriousness of the coronavirus crisis.

Unfortunately, the political responses from the White House had already sent inconsistent messages about the pandemic, prioritized economic messaging over public health, and very likely delayed the delivery of necessary medical goods and services including testing equipment, personal protective gear, and ventilators.

Our government is and ought to be a two-way street. In one direction, as voters, we direct our government about how to address, and we hope solve, the social and economic problems that we face on a daily basis. In the other direction, we look to government to protect us in times of danger. The coronavirus presents exactly that danger. Many local, state, and some federal officials have responded, and we have listened. Many of us have taken the precautions seriously, as well we should, even in the face of scientific uncertainty.

In my next post, I'll cover some recommendations related to the precautionary principle and enhancing and improving the role of government in responding to pandemics and other crises.