A Bioethical Dilemma in the UK Vaccine Rollout

Oops:

The government and NHS England has ruled that GPs must move the second dose of the vaccine to 12 weeks after the first, instead of the originally planned three-week gap.

And from Monday, January 11 they were informed that they had to postpone any second dose vaccines they had originally booked within the timeframe.

Since December 15, 2,000 people in Tameside and Glossop received their second dose before the change in policy.

Dr Alan Dow, who works at in Cottage Lane Surgery in Glossop told a meeting of the primary care committee that some GPs feel they have been put in an ‘impossible position’ by the new national mandate.

“The breaking of the consent for the three week promise was a big thing,” he said.

“I personally told people that face to face as I vaccinated them on the day and then suddenly we can’t do it. That’s a big thing in general practice actually, breaking consent with our patients.

“It is close to moral injury, if not actually. I already think we’re out on a limb in terms of evidence.”

Moral injury is defined as the profound psychological distress which results from actions, or the lack of them, which violate one’s moral or ethical code.

Dr Dow added that he could understand the position of the medical chiefs to delay the second dose, but did not know how much that took into account ‘breaking consent which has been the model of personal care in the NHS for 70 plus years’.

The Pfizer vaccine has only been validated for its original 2 dose protocol (with that specific timing). We do not know how a 4x increase in the spacing affects the protection afforded by the vaccine. Perhaps you end up with the same protection (≈90%). Perhaps it’s a bit better. Perhaps it’s a lot worse! (There’s evidence of some protection from a single dose, but we probably only have data from three weeks after.) Lots of things could happen. We haven’t studied it so we don’t know. We don’t, as far as I know, have a great theoretical model that would help us make an educated guess.

Thus, a bunch of people are being subjected to an experimental treatment. It’s likely to be safe (i.e., the risks from the treatment itself are low…thought that’s more theoretical; mRNA clears in a few weeks; exposure to vaccine levels of spike protein don’t trigger cytokine storms; thus, from a safety perspective, get as many shots as you like). But we don’t know how effective it is and we won’t know until we see how many people in the new arm of the experiment contract severe COVID.

This would be fine…if the people involved gave informed consent in advance. They, of course, did not give such consent. The GPs told their patients they were going to get a certain treatment and then had to tell them they were going to get an untested alternative instead.

Ordinarily, this is no dilemma. It’s straight up wrong. Oh sure, if the second doses were destroyed or contaminated, etc., it would be unfortunate but not a wrongdoing in the simple scenarios. If only some were, then we’d have an allocation problem. Of course, assuming stocks can be replenished we could always have an interrupted treatment and then do the full treatment when possible.

But there is a dilemma! The UK is in the midst of a very bad outbreak with the whole country experiencing high rates of infection. The whole healthcare system is near the breaking point.

Things will get worse before getting better due to the time lag between exposure and manifestation of illness as well as the lack of transmission control and asymptomatic spreaders. Some people who will get sick are already infected. Some people who will get sick in the current trajectory are not yet infected. If we can get some of the second group at least one dose of the vaccine it could perhaps half the number of that second group getting hospitalised for COVID.

From a bioethics instruction perspective this is a pedogogically well structure dilemma. In first framing, you have deontological considerations (lack of consent) in tension with utilitarian ones (saving lives). If you poke at little further you have consequentialist issues buttressing the deontological ones (some of the people who relied on the normal course might get seriously ill; the “moral injury” is also a factor). There’s a lot of potential second order effects.

I wish it were a hypothetical instead of this grim reality.

I don’t envy any of the decision makers.

Ideally, everyone would eventually get the normal two dose protocol (for a total of three doses). It’d be best if everyone who’s received a dose got a choice whether to finish their treatment or postpone it, but it would depend a bit on the numbers. I think doing a one does, then delayed two dose is better than an off label 2 dose (unless we get excellent results from wide spaced 2 dose trials).

The damage to doctor/patient relations needs addressing as well. The government so routinely squanders everything, it’s hard to know the marginal effect of this overall, but there are directly relations that need restitution as well.

Update: Hmm:

For the Pfizer vaccine, the impact of stretching out the two doses hasn’t been tested in clinical trials. Pfizer cautioned that its trial only investigated giving two doses 21 days apart – far less than 12 weeks. But evidence increasingly suggests that spacing out doses of the AstraZeneca/Oxford vaccine may be more effective at protecting people.

The main risk is that people’s level of immunity falls before they receive their second dose, putting them at risk of Covid-19 – although this risk would still be lower than if they’d received no vaccine, and would be boosted when they eventually received their second shot.

However, a consensus statement by the British Society for Immunologists said that delaying the booster dose by eight or nine weeks was unlikely make much difference in the longer term.

Hmmmmm (following the AZ link):

Evidence now suggests that spacing out doses of the AstraZeneca/Oxford vaccine may be more effective at protecting people. Clinical trials revealed the efficacy of the vaccine was substantially higher, at 90%, in a subgroup of people who received half a dose followed by a full dose, rather than two full doses, which had an efficacy of 62%.

But Prof Wei Shen Lim, the chair of the Covid-19 immunisation group of the JCVI, told MPs further analysis by AstraZeneca showed the improved protection came from spacing out the doses.

“People who had the half dose then full dose were those who were vaccinated at a longer time interval, roughly six to 12 weeks, and what they’ve seen in their data is that people who have the second dose later probably have a three times higher antibody level than those who were vaccinated earlier. So if anything, it suggests that increasing the dose interval is beneficial,” he said.

Sir Mene Pangalos, the executive vice-president of biopharmaceuticals research and development at AstraZeneca, told the committee the first vaccine shot was more protective over time.

“What we’re seeing with our data so far is that as you go to the eight- to 12-week interval, you actually increase vaccine efficacy. People are protected enough with the first dose, to around 70%, but we see that within that eight- to 12-week interval is actually the sweet spot,” he said.

Again, I’ve not delved, but this reporting is worrisome. It is suggestive of motivated reasoning.

The brutal fact is that AstraZeneca and Oxford botched their trial. They didn’t do what they said they would do by accident. Maybe this will be a happy accident, but now you have, “Oh it’s the half dose, no, Oh it’s the spacing, no, oh, maybe it’s not the booster”. That’s not good!

It doesn’t mean that they are wrong but it’s all rather untrustworthy.

A Bit on Alfie Evans

Note: This is all phrased in cold, blunt terms. I don’t think any member of his family will read this and it’s not at all the kind of language one should use when discussing it with people who are involved. I’d caution about reading this if you had an analogous loss: I didn’t write it with such readers in mind so the way I put things might be upsetting. Self care is important! What I wrote isn’t mind blowing or so unique that anyone needs to read it.

Kevin Drum wonders why cases like Alfie Evans generate so much activity from the sanctity of life folks:

The general tenor of their criticism was that the abortion lobby was no longer satisfied with killing infants in the womb. Now they wanted to kill them after they were born based on nothing more than their opinion about Alfie’s quality of life.

I find it puzzling that this is a hill they want to die on. It’s much like the Terry Schiavo case, and in both cases the pro-life folks were defending the notion that a person could still be alive even if their brain was all but destroyed. Why? There are always judgment calls to be made about when life ends, but lack of brain activity is pretty clear cut. In the case of Alfie Evans, his parents were effectively performing an experiment to see how long a brain-dead child’s heart can be kept beating.

But wouldn’t it be better to have that argument in a case that’s genuinely on the bubble rather than a case in which it’s absolutely indisputable that the child’s brain is gone? Why is the pro-life right so attached to cases like this? Keeping the heart beating in a brain-dead child really doesn’t seem to serve anyone’s purpose.

I want to talk a bit about the ethic of this case, but first a quick point about the politics and Drum’s question: It’s almost certainly not planned or the result of any strategy. Basically, only hopeless cases generate much conflict between caregivers and family members. Some few of them go viral and there you are. Even if there were master planning, hopeless cases might make sense precisely because they are irrational (so the judges and caregivers and sensible family members won’t defer). That the pro life movement is never up in arms against insurance companies is awful and terribly inconsistent, but yeah, that’s how political movements are. The narratives are not subject to overall consistency checks but to identity, repetition, history, etc.

Ethically, if we ignore the parents wishes for a moment, this is an easy case. There was no treatment and there was (essentially) no brain (or at least no brain that supports any cognition or experience). There’s was no medical point in maintaining the body.

From what I can tell, there’s no suffering either. Even if some sort of pain signals and processing occurred, there’d be no subject to experience it.

But here’s where it seems a big old “Why not let the parents do the pointless thing they want to do?” question has a lot of punch. It’d be a tremendous waste of resources to have flown Alfie Evens to Italy, but it was all, essentially, private money. We “waste” money on all sorts of things, including elaborate coffins. Drum discusses the need to protect the parents from hustlers, but here the “hustler” is the Catholic Church. And they would pay for it. We don’t think that’s the kind of hustle adults need or get protection from. (Obviously, if you don’t think the Catholic Church isn’t a hustle but a reasonable form of life and a respect worthy culture, this point is even stronger. However, even if you do think its a hustle, it’s a protected hustle and definitely not on part with quacks and pop up cults, etc. The family won’t lose all their assets at the end of it.)

Even if we take a strong line against medical quackery and on the welfare of the child, it seemed pretty clear that there was no child. If we believe that, then all that’s left is resource allocation, family suffering, and political fallout. It’s private money, the family probably suffered more with the given decision, and it was probably net bad politics. (I.e., it didn’t make sensible rulings, decisions, and laws more likely and may have made them less likely.)

In medicine, preserving dignity is important, but we have to be very careful when determining what concept of dignity is controlling. Given that Alfie wouldn’t suffer harm (since he was already dead), how the parents wanted to deal with his (breathing!) corpse seems to control (up through resource allocation and safety).

I doubt that yielding would have that much beneficial political effects though it might have yielded fewer death threats. But the family would have been happier.

The Risk of Appropriation and Inappropriateness

The copy of Whistle Down the Wind that I bought from the HMV bricks and mortar store.

My sweetie, Zoe Mulford, is white. I’m at least half white (depending how you count my Iranian father). We both grew up with a fairly high socio-economic status and we retain a big ole chunk of that. We can afford for Zoe to be a full time musician with essentially zero net income (or, properly accounted, negative, as we subsidize her work from the household income). There was a point where this was challenging on our joint income (though we always had family and friends to help out…which makes a huge difference) but we’re pretty well off now. Our household income is well in excess of the median for the UK.

So we are very very privileged on a world scale and even on a US/UK scale.

Zoe is a folk musician…a singer-songwriter. I believe that she’s is very very good. (This isn’t too surprising, given my relationship with her, but there’s plenty of other evidence thereof.) However, she is, to date, obscure. She has had a slowly rising profile, but it’s small. Having “The President Sang Amazing Grace” covered by Joan Baez is a big (potential) inflection point for her career. I’ve been obsessively tracking reviews and other events that mention Zoe’s song and there’s been a lot of good stuff. A lot. Way more (by volume, not necessarily intensity) than ever before.

We figured that if any song from Small Brown Birds would blow up at all, it’d be “The President Sang Amazing Grace”. We did a little prep for this (mostly making a video).

And this is great. I’m exhilarated and proud and excited. If you look at Zoe’s songbook, you’ll see this is no fluke. She deserves notice.

However, the song is about a tragedy and Obama’s response. That tragedy happened to black people because they were black. We’re benefiting indirectly from that tragedy. We will receive some money in terms of royalties. Zoe already gets some from sales of Small Brown Birds, but I expect that will be tiny compared to the royalty check…not that the royalty check will be huge. If it were to go gold, it might…might…yield tens of thousands of dollars (total). That would be really surprising as no Baez album since the 80s has gone gold. In today’s world of streaming etc. it seems very unlikely. While there’s a big (by our standards) publicity push, it’s not like her label is paying HMV to put Whistle Down the Wind on an endcap. Obviously, it’s still a pretty significant career boost, so that’s a benefit as well and a pretty significant one.

Note: I just went to HMV and Whistle Down the Wind does have special placement. I don’t know if I just missed it yesterday or they put it up after I was there. You can see in on the “New and Trending” wall.

Thus, we have to deal with issues of appropriation and inappropriateness.

The song came to Zoe, as many do. The election of Trump had just happened and she kept thinking about how we were going to miss the Obama’s in the White House. The contrast in policy and propriety between the Obama administration and the Trump could not be more dramatic. “The President Sang Amazing Grace” came out of that feeling of loss and dread. She was concerned about whether she had the right…or whether it was right…to write and record and perform this song. She consulted with various people who were positive, but we both can imagine other people who would not be. There is a case for it being, if not quite typical appropriation, of being inappropriate. There’s inherently some degree of standing over rather than standing with when people in our position benefit from our reactions to such events. There’s also some standing with!

One mitigation is to donate some chunk of the royalties (or beyond!) to Black Lives Matter (or similar groups; BLM is our first stop). That’s our current plan.

The best thing would be for history to change so the shooting never happened and that Cynthia Marie Graham Hurd, Susie Jackson, Ethel Lee Lance, Depayne Middleton-Doctor, Clementa C. Pinckney, Tywanza Sanders, Daniel Simmons, Sharonda Coleman-Singleton, and Myra Thompson survived that day as an ordinary, quiet day.