Can't, Can, Should, Must
Creating A Framework For Public Health Policy Compatible With A Free Society
As pandemic restrictions continue to wind down in many parts of the world, a lot of attention has been focused on the agencies making the decisions. In the US, this has brought a fair amount of scrutiny to the CDC and the FDA. For those who don’t know, the CDC is the entity that makes public health recommendations and often sets the tone of public health policy. The FDA approves (and revokes the approval of) drugs and therapeutic interventions.
If you’re still paying attention, you’ve probably seen a variation of the following article recently:
https://www.reuters.com/world/us/cdc-announces-revamp-plans-washington-post-2022-04-04/
Essentially, the CDC has found itself boxed in to a corner. Everyone is angry with it. There has been an enormous amount of pressure from both sides. Some believe that it has been overly aggressive the entire time, with pretty visible rage surrounding recommendations for mandates or required interventions. On the other side, there is a group that believes that the CDC has allowed the unpopularity of ongoing COVID measures to politically influence its’ recommendations. This group believes that current recommendations don’t go far enough. For the first time during the pandemic, polling shows this latter group to be a significant minority, but it is also the group that has the most trust in the CDC. It is certainly a conundrum for an agency that is trying to appear neutral while wading through highly politicized waters.
Do I believe that outside review or revamping of agency image is going to fix the CDC? I don’t. I believe that this is likely to make things worse, as I suspect that the CDC has a fundamental misunderstanding of what the problem is in the first place. I also suspect that the outside advice will mirror that fundamental misunderstanding. Trust is at an all time low.
We are seeing similar controversies surrounding the FDA. Here is another article addressing recent controversy surrounding the approval of extra booster doses:
https://dailycaller.com/2022/04/06/fda-covid-19-coronavirus-second-booster-authorized-pfizer/
You'll note that I cited a right wing news source. There was a similar piece in The Washington Post that I shared on my personal Facebook page that seems to have been scrubbed from social media and most search engines. Talk about ways to limit trust.
What Is The Issue?
There are in fact two major issues surrounding these agencies. They are the same issues, which isn’t a surprise as they tend to work together. I’m going to lay them out separately.
Nobody Trusts You
The one thing that everyone seems to agree on is that these agencies are not acting objectively. Those concerns about objectivity tend to run in both directions. This may include making overly aggressive recommendations for schools based on influence from Teacher’s Unions:
https://www.dailymail.co.uk/news/article-10667987/Republicans-expose-cozy-relationship-CDC-teachers-union-school-reopenings.html
or it may include shortening quarantine under the influence of the airline industry:
https://www.cnbc.com/2021/12/21/delta-asks-cdc-to-cut-quarantine-guidelines-for-breakthrough-covid-citing-workforce-impact-.html
We as a society are going to have fundamental disagreements on the above issues, but the one thing we probably don’t want is individual politically motivated entities writing CDC policy. It doesn’t matter which direction those policy proposals lean, because it further supports the notion that these recommendations aren’t based on anything objective at all.
Even within the scientific community, it is starting to look more and more like the CDC and FDA both decide what they are going to do politically, and then search for data or scientists to support that thing. We often hear that the CDC is going to let the science lead, but the opposite has been true repeatedly in real life. The CDC often justifies these positions by releasing scientific data through the Morbidity and Mortality Weekly Review (MMWR). Many of these articles have certainly been selective in the way that they present data, and I suspect that many are flawed enough that they would never have made it through peer review in most journals.
Trust is hard to win and easy to lose. We have clearly crossed the threshold in which that trust is lost.
By May of 2021, only half Americans trusted the CDC:
https://www.npr.org/2021/05/13/996331692/poll-finds-public-health-has-a-trust-problem
By January of this year, that number was down to 44%:
https://nypost.com/2022/04/04/cdc-to-revamp-amid-eroding-public-trust/
It’s worth noting that the sort of people who tend to be more trusting of the CDC are the sort of people more likely to respond to a poll about the CDC, so I suspect the reality is even worse. It’s also worth noting that a strong majority (69%) did trust the CDC at the beginning of the pandemic.
The CDC is also caught up in a much broader trend of selective data release that has become obvious to the average individual. The article above refers to just such an example by the CDC. We are also seeing the same thing worldwide, with countries removing raw data because of claims that the raw data is “misinterpreted.”
https://www.heraldscotland.com/news/19932323.public-health-scotland-pulls-covid-case-rate-data-claims-demonstrates-conclusively-vaccines-not-working/
The fundamental problem of course is that this means we are seeing an international trend of intentionally reduced transparency over precisely the most politicized topics. You and I might disagree over the relevance of a particular data set, but I certainly won’t trust your interpretation if you don’t even show me your data. If your excuse when you get caught hiding the data is that you didn’t trust me, I assure you that it doesn’t increase my trust in you.
Here is where I believe that the CDC and FDA both fundamentally misunderstand the trust issue. I believe that those running these agencies believe that they are correct. When they ultimately discover they aren’t correct, they still believe that they were the most correct based on the data they had. This is in spite of numerous entities predicting exactly what happened far ahead of the agencies. All legitimate criticisms of performance are tied to this argument surrounding “rapidly changing data” which just so happens to be the same data that those who did accurately predict outcomes also had. In fact, since we now know that data was being suppressed, those entities performed better with LESS data. We have internet blogs and podcasts that are run by random physicians and scientists that have made more accurate predictions than the agencies that are supposed to be the gold standard.
My concern is that the agencies believe that the problem is messaging. They believe that they are correct, and the issue is that people don’t see how correct they are. While I agree that the messaging has been awful, (and I still haven’t figured out why the CDC can’t hire a person that knows how to talk to people), the problem is the way it makes recommendations in the first place. It is the entire process that is wrong. People have longer memories than they are given credit for. If you make a recommendation that turns out to be ill advised, you may be forgiven. If your whole approach turns out to be wrong, that gets progressively less likely.
There has now been well documented active suppression of alternative viewpoints from well qualified people, and the promotion of suppressing those viewpoints came in part from these agencies. At this stage, it is irrelevant whether they were right or wrong. What matters is that they were suppressed. It means that we aren’t getting the whole story. As George RR Martin wrote in A Clash of Kings, “When you tear out a man's tongue, you are not proving him a liar, you're only telling the world that you fear what he might say.”
You lose the ability to get things wrong AND retain trust if you’ve been actively suppressing alternative viewpoints. Calling everything that you disagree with “misinformation” doesn’t make it so. This doesn’t look like an honest mistake from the outside. It looks like someone promoting an agenda. When people feel that you are promoting an agenda that doesn’t align with their personal beliefs, they don’t trust you. In fact, it makes them more likely to flock to legitimate misinformation, as there is no longer a rudder on the ship of potential truth.
Force Makes Things Political
Politics by definition is force. Political decisions primarily surround not what people choose to do, but rather what they are forced to do. Your decision to go out to dinner isn’t typically considered political. The decisions surrounding where to place the traffic lights you stop at or the tax rate you pay on your food are political. These things become political because they are not voluntary. If you choose to run the traffic light or refuse to pay the sales tax on your dinner, you can find yourself in handcuffs.
Throughout the pandemic, the CDC has been granted a large amount of regulatory power. Additionally, many political entities have taken CDC recommendations at face value, which means that CDC recommendations are rapidly translated to force.
I’ve written in the past about how science, ethics, and politics are different. Science can tell you what will happen if you do something, but it cannot tell you whether you should do it. It also can’t tell you how the weight of that impact should be valued against other concerns. This idea of moralized science is fundamentally broken. Science is amoral.
The CDC has attempted to both be in the regulatory business AND sell itself as a neutral arbiter of scientific data. This is fundamentally impossible. It is almost certainly why much of the data we are getting is so bad. The CDC has embraced its’ regulatory function first, while allowing the scientific function to take a back seat. Thus, it is looking for science to back a specific recommendation, which often excludes abundant science that might back a different recommendation. It also assumes that the value of its recommendation exceeds the value of alternatives.
Masks may reduce the rate of COVID transmission in schools, but are almost certainly now tied to learning delays. School closures do reduce transmission in schools, but at high academic and social costs. Business closures may reduce the rate of transmission, but only temporarily until they are reopened. Vaccines reduce bad COVID outcomes for an imperfectly understood duration in a lot of people, but they also hurt a minority of people that may never have had a bad COVID outcome.
These are all fairly well established at this point, and the relative weight placed on each cannot be determined by “science.” Thus, an official position taken by the CDC on the issue is by definition going to involve politics.
This is more complex at the FDA. The FDA is supposed to have a regulatory function, but I believe it has mixed up the extent of that function as well. The role of the FDA is to assure that drugs and devices are fundamentally safe. It is also to declare when a drug has been proven with a reasonable likelihood to provide a benefit against a specific disease process. When something has met the bar for safety, we have historically allowed physicians to use that drug “off-label” for other disease processes for which the benefits have been less well established.
The FDA has instead gotten in to the business of telling people what they have to do, which inevitably makes it all the more political. FDA approval has also become a bit of a lightning rod for entities trying to implement mandates. This has fundamentally shifted the function of the FDA from its’ proper role as an entity which states “this drug is sufficiently safe,” to one in which it states, “you must take or not take this drug.”
With the same rapidly changing scientific data that the CDC uses to justify changing positions, we are also now frequently left with coerced medication policies that no longer impart the function under which they were justified. We are also left with situations where people were denied treatments that both they and their physician wanted to try.
I’ve never been convinced of the efficacy of Ivermectin for example, but as an FDA approved drug, physicians should be able to prescribe it off label with informed consent. An application for EUA approval of Novavax (the first Covid vaccine using previously established technology) has been sitting at the FDA since January, being ignored. Why would we not want additional options unless there is an underlying political concern?
I think again, there is a fundamental misunderstanding of the role of the FDA. In all but the most extreme cases, the FDA is supposed to determine if something is safe, and if it works. It is then up to an individual physician through proper informed consent to determine if that intervention should be given to a specific patient.
A Proposed Solution
While I assure you that no one cares what I have to say at any of our federal agencies, I’d still love to propose a solution to the problem. The title of this article is “Can’t, Can, Should, Must.” Taken back to fundamentals, this is how all pandemic policy is made. We tell people that they can’t do something, that they can try something, that should do something, or that they must do something under threat of force or coercion.
Can’t and must are authoritarian. They require coercion and possibly enforcement. Almost our entire early pandemic policy was built on can’t and must. You can’t leave your house unless you are engaging in “essential” activity. You must quarantine if you were exposed. You can’t get together with a group of individuals from outside your household. You must wear a mask whenever you are in a public place.
The problem with can’t and must are that these are always going to be political, because they always require force or coercion. If people can ignore them with impunity, than they really aren’t a can’t or must. This requires activation of the political apparatus. When something is political, it will become controversial. It also places the specific values of the state agency over the individual concerns regarding a specific course of action. The free fall in trust over the government handling of the pandemic (which was readily apparent over the first few weeks of “lockdown”) can be tied to this approach.
On the other hand, the agencies rarely used the more empowering can and should. One could say, you can limit your interactions with people outside of your household if you are in a high risk group and cases are also high to reduce risk of exposure. You should consider wearing a high quality mask in certain high risk situations. There are non-political and largely non-controversial. Most criticisms surrounding these courses of actions only exist because of the initial coercion
From the perspective of the FDA, vaccine politics is so controversial precisely because everything is tied up in can’t and must. Because the government controls the vaccine supply, it has been setting up roadblocks for workers getting vaccine boosters who want them. It has paradoxically been pushing policies to coerce people in to getting them who do NOT want them. It is tied up in a highly authoritarian viewpoint in which everyone has to do the same thing. This is political.
Imagine a vaccine policy that looked like this:
“Everyone over the age of five can receive Covid-19 vaccination if recommended by a physician. This includes additional booster doses. Those in high risk groups, especially if not previously infected, should strongly consider vaccination to reduce the risk of severe disease.” You will note that there is no can’t or must in that policy. There is nothing in that policy that forces people to do something they don’t want to do. On the other hand, it allows individuals to take advantage of the product while empowering physicians to make those decisions based on individualized risk assessments.
The only reason the FDA needed to approve a second booster is because the government controls the vaccine supply and is only releasing boosters under specific EUA justifications. This is entirely unnecessary. If certain healthcare workers or high risk individuals want additional boosters, they should be able to receive them based on the recommendations of a physician. If some people don’t, they shouldn’t be coerced in to doing so. Remember, the data is rapidly changing, and the agencies haven’t gotten everything right.
As we see the release of variant specific boosters and other products hit the market that will likely have even less supporting data, the FDA can depoliticize the process by reverting back to its’ real purpose. Yes or no, this product is reasonably safe. Yes or no, this product appears to work. If the answer is yes to the first, allow people to try it. If it is yes to both, recommend it. Don’t force it.
If we decide that something is so fundamental that it requires force, then we need to stop pretending that it is a purely scientific position. We need to go through the proper political channels. We don’t need executive actions, states of emergency, or agency directives. If you want to force people to do something, pass a bill and make it a law. That law needs to be in compliance with The Constitution of The United States and the state in which the law is implemented. Agency directives or executive actions largely occur because there is insufficient support for a law. People also conclude that the proper processes have been violated, and they often feel that their rights have been violated. If this occurs at the behest of a specific agency, that agency becomes the enemy.
If we allow the rules to fall back under the proper political processes, it will also help to depoliticize the entities making recommendations. These agencies will have far less incentive to make political decisions, because they will not have power to enforce them. I would love to see a real argument/counter argument over specific policies from these agencies. This is why we might want to do something, and this is why we might not. Then use that data when crafting legislation. The agencies will no longer be in charge of can’t and must.
We need open and independent review of agency recommendations from multiple sources, and the agencies need to publish and respond to those criticisms. If they are sufficiently troublesome, the agencies need to admit they got it wrong. The current system of blocking out your own experts (let alone outside experts) is deeply flawed. Calling a token meeting of your advisory committee after you’ve already made a decision doesn’t eradicate the flaw.
By generating independent systems of accountability, we can make the can and should accurate enough to have some integrity. The truth is that if people really trusted the can and should, you’d have a much smaller need for can’t and must.
In Conclusion
Our American public health agencies are in a crisis. That crisis is self made. It is not just a crisis for the agencies, but rather it is a crisis for the entire country. We are radically vulnerable, unable to respond to any new public health threat.
For us to rebuild confidence in our public health systems, we must rebuild trust. To rebuild trust, we need to depoliticize the science, while simultaneously acknowledging the fact that policy decision making is inevitably political. We need to get scientific agencies out of the enforcement business and return regulatory agencies to a proper and limited regulatory role.
In the end, most decisions should surround recommendations, not mandates. You can or should is the proper first step approach to an intervention. The avoidance of wide scale use of can’t or must will help depoliticize decision making. Proper independent review that intentionally seeks opposing views will help to validate the can and should.
I am just one physician who has been practicing two years of pandemic medicine. I don’t expect to be taken at face value. Nevertheless, I hope that Dr. Walensky at the CDC can take a step back. Make a liar out of me. Through independent review, I hope that these problems are identified. Only then, can we take the necessary steps to fix the problem.