Category: Medicine
The Most Important Act of the Last Two Decades?
A good case can be made that Project Bioshield is the most important piece of legislation passed in the last twenty years. Passed under President Bush in 2004, Project Bioshield’s primary goal was to create advance market commitments to purchase countermeasures for chemical, biological, radiological or nuclear agents (CBRN). Several billion dollars have been spent in this area promoting anthrax and smallpox vaccines and various antitoxins for botulism and nuclear threats. The record on these advance market commitments is mixed with some notable failures.
The second thing the act did is to reduce some paperwork requirements on purchases and research funding. Those seem fine although the simplified procedure is itself too complex and the amounts such simplified procedures apply to are too small, e.g.
The Project Bioshield Act authorizes the HHS Secretary to use an expedited award process for grants, contracts, and cooperative agreements related to CBRN countermeasure R&D Activity, if the Secretary deems a pressing need for an expedited award exists. The authority is limited to awards of $1.5 million or less.
The third aspect of the act was not considered a big deal at the time but is the one that has proved to be the most important. Project Bioshield created the Emergency Use Authorization (EUA). In other words, prior to 2004 the FDA had no clear legislative authority to authorize an unapproved vaccine, drug or device. Without Project Bioshield and the EUA procedure the FDA might have eventually found some way to authorize vaccines before full approval. Britain, for example, used a temporary authorization procedure. Or the FDA might have sped up full approval but given the FDA’s lethargic record it’s easy to imagine that this would have taken months longer than the EUA process. As a result, the EUA procedure created by Project Bioshield probably saved 100,000 or more lives.
Important Addendum: It’s also worth mentioning that the EUA procedure doesn’t just apply to approvals it also allows changes in dosage and labeling. Susan Sherman, the senior attorney with the HHS Office of the General Counsel, noted in 2009 that a drug that had been approved for individual health in a non-emergency might have to be used very differently for public health in an emergency and that the EUA process could be used to adjust to these differences:
“You can change the labeling. You can change the information. You can change the dosage. You can give it to populations for which wasn’t approved.” She continued, “In some sense we had to match up in practice a public health response where you might not have the precise labeling that your physician would prescribe to you. There are a lot of variables that are necessary for the public health responders that don’t necessarily match what the approved drug would look like if you just went to your physician and got it because you had that illness.
In other words, the EUA process was made to allow for procedures such as fractional dosing. It’s too late for fractional dosing in the United States (but we should use it for boosters) but fractional dosing remains a vital tool to deal with the global shortage of vaccines.
Physical vs. mental ailments
A loyal MR reader asks:
Physical ailments generally lead to behaviors that offset or improve them, whereas mental ailments often seem to lead to behaviors that make them worse (eg it’s hard to exercise when you’re depressed)
This seems very odd to me; why would this be the case? Are there any physical diseases that lead to reinforcing rather than mitigating behavior? Does this imply that mental illness is a post-evolutionary phenomenon?
Model this, or do you dispute the stylized facts?
The incentives for Mexican hotel Covid testing
Yes you need a negative result on the test to return to the United States, but you never know the sensitivity of the test you are taking. It should be from an “approved provider,” but what does that mean? No authority from the United States can readily verify how good the test is.
Let us say you are a hotel owner, which kind of testing service do you wish to commission to send around to your rooms to test your American guests? A highly sensitive test that will yield periodic false positives, or a not very sensitive test that won’t generate false positives and might even result in some false negatives? And say some of your guests truly will be Covid-positive — do you wish to keep them in their rooms for another week or two, with all the attendant risks, or do you wish to send them along their way?
You don’t even have to imagine that the hotel owners are entirely cynical. They themselves can’t judge the accuracy of the tests, so a service that yielded a fair number of Covid positives could be seen as “they make too many mistakes and won’t let our guests leave, we don’t want them.” If the Delta variant is outracing publicity about the Delta variant, as was the case for a while in Tulum, such a hotelier reaction might be all the more likely.
I did in fact test negative. And the testers were very nice to me.
Our regulatory state is still, still, still failing us
The U.S. agency leading the fight against Covid-19 gave up a crucial surveillance tool tracking the effectiveness of vaccines just as a troublesome new variant of the virus was emerging.
While the Centers for Disease Control and Prevention stopped comprehensively tracking what are known as vaccine breakthrough cases in May, the consequences of that choice are only now beginning to show.
Here is more from Bloomberg, tragic and stupid throughout.
Welcome to the Club
Ashish Jha, dean of the School of Public Health at Brown University, has had it with the FDA:
Nearly all public-health authorities in the country are urging people to get vaccines. We see the incredible results that the vaccines have had and how many lives they’re saving, and still the F.D.A. has not offered full, permanent approval of the vaccine. President Biden suggested it might take several more months. How do you understand that, or how can that be defended, if it can be?
I find it incredibly puzzling what exactly the F.D.A. is doing. The F.D.A. says that it typically takes them six months or sometimes as much as a year to fully approve a new product. And, generally, we appreciate that. There are two components to that. One is that they want to see a large amount of data, and they want to go through that carefully, and I think that’s essential. Then the second is that there’s a process, which can take a while. This is a global emergency, and while all of us want to make sure that the F.D.A. does its job, most of us also feel that just operating on standard procedures may not be the right thing to do here, and that there are things that can be sped up. Just as with the development of vaccines, we didn’t cut any corners. We did all the steps, but we did it much, much faster. The F.D.A. has to go much, much faster.
The other thing about the data—the amount of data that the vaccines have generated, the number of people who’ve been vaccinated, and the scrutiny that the data has received. I mean, my goodness, this data has been scrutinized and looked over more than—
I’d imagine it’s more than any data in modern history, right?
Any therapy, any vaccine ever. These are the most highly scrutinized medical products we have ever had, and I don’t understand what the F.D.A. is doing.
I’m pleased that Jha and others like Eric Topol are becoming frustrated with FDA delay. But take it from an OG, the FDA is doing what it has always done. What has changed isn’t the FDA but that more people are paying attention now that they have something personal at stake.
I am reminded of this story from 2016:
Mary Pazdur had exhausted the usual drugs for ovarian cancer, and with her tumors growing and her condition deteriorating, her last hope seemed to be an experimental compound that had yet to be approved by federal regulators.
So she appealed to the Food and Drug Administration, whose oncology chief for the last 16 years, Dr. Richard Pazdur, has been a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.
He was also Mary’s husband.
…When asked specifically how his wife’s illness had changed his work at the F.D.A., Dr. Pazdur said he was intent on making decisions more quickly.
“I have a much greater sense of urgency these days,” Dr. Pazdur, 63, said in an interview. “I have been on a jihad to streamline the review process and get things out the door faster. I have evolved from regulator to regulator-advocate.”
I do hope that when the pandemic is over we don’t forget that for patients with life-threatening diseases it’s always been an emergency.
Hat tip: John Chilton.
Richard Hanania on safety craziness
There are other complications too; some people are just low IQ, and maybe their dumb beliefs aren’t their fault. But if you believe in personal responsibility at all as a guide to policy, for reasons of utilitarianism or justice, you have to assess blame at some point. Incentivizing people to get free vaccinations is not the same as incentivizing those with IQs of 100 to be astrophysicists, or poor people to buy Teslas; this is clearly in the realm of possible, and mostly involves overcoming motivated reasoning and laziness. COVID-19 rates of infection vary across time, likely because people change their behavior depending on how much spread there is in their community, and there is nothing to indicate that the unvaccinated are incapable of considering costs and benefits at all when it comes to the decision over whether to get vaccinated. This means that private sector mandates are therefore an unalloyed good, as I’ve pointed out before, and Republicans should be ashamed of themselves for standing in their way, as they have in certain states.
…Unfortunately, we live under a government, and particularly a public health community, that can’t do cost-benefit analysis, and doesn’t have the stomach for personal responsibility either. So we’re going to have an entire generation robbed of a normal childhood, and perhaps other restrictions too that will remain permanent. The question is how we will deal with COVID-19 now that we know it will never go away
Here is his Substack link, recommended.
The vaccine lottery is a worthwhile investment
Conditional cash lotteries (CCLs) provide people with opportunities to win monetary prizes only if they make specific behavioral changes. We conduct a case study of Ohio’s Vax-A-Million initiative, the first CCL targeting COVID-19 vaccinations. Forming a synthetic control from other states, we find that Ohio’s incentive scheme increases the vaccinated share of state population by 1.5 percent (0.7 pp), costing sixty-eight dollars per person persuaded to vaccinate. We show this causes significant reductions in COVID-19, preventing at least one infection for every six vaccinations that the lottery had successfully encouraged. These findings are promising for similar CCL public health initiatives.
That is from a new paper by Andrew Barber and Jeremy West.
The Farrago of International Travel Restrictions
International travel restrictions are a farrago built on fear, statistical confusion, and out-dated information. The US, for example, is still requiring a virus test to enter the US but not proof of vaccination. In other words, a fully vaccinated citizen can now fly to Canada (with Canadian requirements) but if they want back in they need to have had a virus test. Ridiculous.
Even more ridiculous, Chinese, European and British citizens are still not allowed into the United States. Why? China, for example, has almost no COVID cases–thus there is no reason to restrict Chinese citizens from traveling to the United States. Indeed, President Trump rescinded these restrictions at the end of his term but Biden reinstated them immediately. Why? Travel is now banned from many countries with low COVID and high vaccination rates while allowed from many countries with high COVID rates and low vaccination rates. There is no rhyme or reason to the travel bans and restrictions.
I propose we eliminate the farrago with a simple rule. Anyone vaccinated with a full dose of any WHO approved vaccine should be allowed to visit the United States without restriction. People on twitter responded “but even a vaccinated person could still be a carrier!” No kidding. So what? We cannot eliminate all risk. The logic of allowing vaccinated travelers into the United States is simple–a fully vaccinated visitor is safer than the average US citizen. Thus, allowing more vaccinated people into the United States is not especially risky and is having beneficial effects on the economy.
“Vaccine passports” became politically charged but what we have now is a bizarre combination of “testing passports” and “no passports.” In contrast, a vaccination requirement for travel is simpler, cheaper, more convenient and more effective than a test and it creates greater freedom than no passport at all. A vaccine requirement is no more difficult to enforce than a testing requirement. Indeed, the United States has in the past required vaccination prior to arrival so this would hardly be unprecedented. For special cases, a test could be allowed in lieu of a vaccine, especially if it was followed up with an airport vaccination but vaccination should be the primary requirement.
To recap: Anyone vaccinated with a full dose of any WHO approved vaccine should be allowed to visit the United States without restriction.
Addendum: A mix and match from any two WHO approved vaccines counts as a full dose!
Why vaccine passports are a welfare-dominated approach
Use monetary rewards (or penalties) if need be. Here is Joshua Gans applying some game theory to the vaccine passport idea:
Vaccine hesitancy is modelled as an endogenous decision within a behavioural SIR model with endogenous agent activity. It is shown that policy interventions that directly target costs associated with vaccine adoption may counter vaccine hesitancy while those that manipulate the utility of unvaccinated agents will either lead to the same or lower rates of vaccine adoption. This latter effect arises with vaccine passports whose effects are mitigated in equilibrium by reductions in viral/disease prevalence that themselves reduce the demand for vaccination.
A “utility tax” is rarely a good idea. Besides what happens if you lose your smart phone? Don’t have one to begin with? Arrive from another country with an incompatible information/verification system?
With cases falling in both the UK and Netherlands, the vaccine passport idea, at the governmental level, is looking worse and worse. That said, I am all for private entities making their own decisions on these issues, and generally I am happy when I see employers require vaccination.
Addendum: Here is a Gans tweet storm on the paper.
Swedish study will pay people to get vaccinated
Swedish volunteers will be paid £17 each to be immunised in Europe’s largest test of whether small cash incentives can improve vaccine uptake…
The Swedish study, led by Erik Wengstrom, an economics professor at Lund University, uses gentler methods.
Over the next few weeks 8,200 unvaccinated people under the age of 60 will be split into different groups. Some will be given a voucher worth 200 Swedish kronor (£17) that can be used in most shops if they are vaccinated.
The money is a fraction of the sums being discussed in other countries, but Wengstrom said there was evidence from the US that as little as $25 (£18) was enough to persuade people.
He said: “People might have the intention to get vaccinated, but maybe there’s a little bit of hassle involved and something always gets in the way, so a small incentive might help.”
Other participants will be subjected to “nudge” techniques — attempts to influence people’s behaviour by guiding them towards a particular choice.
Some will be given leaflets about the vaccines’ benefits and side effects; others will be asked to think of the best argument to persuade others to have the vaccine. A third group will be told to draw up a list of their loved ones. “That’s basically encouraging them to think about how the vaccination might protect others,” Wengstrom said.
Here is the full London Times story. Here is further information from Sweden.
Electric shock devices on humans now allowed once again
A Massachusetts school can continue to use electric shock devices to modify behavior by students with intellectual disabilities, a federal court said this month, overturning an attempt by the government to end the controversial practice, which has been described as “torture” by critics but defended by family members.
In a 2-to-1 decision, the judges ruled that a federal ban interfered with the ability of doctors working with the school, the Judge Rotenberg Educational Center, to practice medicine, which is regulated by the state. The Food and Drug Administration sought to prohibit the devices in March 2020, saying that delivering shocks to students presents “an unreasonable and substantial risk of illness or injury.”
Although the F.D.A.’s ban was national, the school in Canton, Mass., appears to be the only facility in the United States using the shock devices to correct self-harming or aggressive behavior…
The treatment, in which students wear a special fanny pack with two protruding wires, typically attached to the arm or leg, can deliver quick shocks to the skin when triggered by a staff member with a remote-control device.
Here is the full NYT story. You might argue this treatment can be useful in many cases, but what exactly is the error rate here? How high an error rate should we be willing to accept? What recourse do the victims have, noting that many probably live under guardianship? How might you model the incentives of the staff at the facility who use this? How well do “prison guards” behave more generally?
As a side note, I think this matter should be handled by legislation rather than the FDA.
Excess Deaths in India
Abhishek Anand, Justin Sandefur, and Arvind Subramanian calculate excess mortality in India since April 2020 based on three different datasets (each with their own challenges.) Each estimate indicates that excess mortality is more likely around 4 million than the official figure of 400,000. These figures accord with what everyone on the ground has been telling me. Nearly all my Indian friends report deaths among their family or friends.
…the most critical take-away is that regardless of source and estimate, actual deaths during the Covid pandemic are likely to have been an order of magnitude greater than the official count. True deaths are likely to be in the several millions not hundreds of thousands, making this arguably India’s worst human tragedy since partition and independence.
Photo Credit: REUTERS/ADNAN ABIDI
Vaccines Dramatically Reduce Deaths
A very good graph from the New Statesman. The vaccines give the body a huge advantage in fighting the virus so even when there are infections the number of deaths is dramatically reduced. This is UK data but the same type of relationship should hold everywhere.
Why should they call us “professors”?
I’ve long wondered about this, and explore that question in my latest Bloomberg column. I’ve discouraged this for a long time:
…I have insisted that my graduate students call me “Tyler.” My goal has been to encourage them to think of themselves as peer researchers who might someday prove me wrong, rather than viewing me as an authority figure who is handing down truth.
And:
Some of the strongest norms are around the title “Doctor.” Just about everyone calls their physician “Doctor,” though the esteemed profession of lawyer does not receive similar treatment. As a Ph.D.-toting academic, I’ve even had people say to me — correctly — “You’re not a real doctor.”
I fear that by ceding this unique authority status to doctors we are making it easier for them to oversell us medical care, a major problem in the U.S. If your doctor suggests that you need a procedure done, it can be hard to say no, especially if you have been deferring to that person for years through the use of an honorific title. On the upside, perhaps all that deference has encouraged many people to get their vaccinations.
There are some arguments for titles:
Sometimes a title can be used to suggest a subordinate position, such as the use of Nurse. It can be an honorific, but it also places the person below the Doctor. The advantage, however, is one of greater anonymity and remove. A woman in particular might prefer “Nurse Washington” over the use of her real full name, given the potential risk of harassment.
Title issues and gender issues intersect in tricky ways. A title such as doctor or professor can give a woman newfound respect, but perhaps the practice hurts respect for women as a whole, since they are titled at lower rates than men.
What I expect we will see is that “established” women and minorities will insist on title usage all the more, to command respect, and under the guise of societal feminization we will evolve a new set of non-egalitarian hierarchies, presented and marketed to us under egalitarian pretenses. On related ideas, see my earlier post on the first date book walk out meme.
Biden, COVID and Mental Health in America
Using US Census Household Pulse Survey data for the period April 2020 to June 2021 we track the evolution of the mental health of nearly 2.3 million Americans during the COVID pandemic. We find anxiety, depression and worry peaked in November 2020, coinciding with the Presidential election. The taking of prescription drugs for mental health conditions peaked two weeks later in December 2020. Mental health improved subsequently such that by April 2021 it was better than it had been a year previously. The probability of having been diagnosed with COVID did not rise significantly in the first half of 2021 but COVID infection rates were higher among the young than the old. COVID diagnoses were significantly lower in States that had voted for Biden in the Presidential Election. The probability of vaccination rose with age, was considerably higher in Biden states, and rose precipitously over the period among the young and old. Anxiety was higher among people in Biden states, whether they had been diagnosed or not, and whether they were vaccinated or not. The association between anxiety and depression and having had COVID was not significant in Biden or Trump states but being vaccinated was associated with lower anxiety and depression, with the effect being larger in Biden states. Whilst being in paid work was associated with lower anxiety, worry and depression and was associated with higher vaccination rates, it also increased the probability of having had COVID.
That is a new NBER working paper from the highly regarded David G. Blanchflower and Alex Bryson. Model that!