OPINION | Try writing some guidelines for everyone, in every situation, under intense scrutiny, with no direct evidence, that fits into all governance structures, and do it yesterday, s'il vous plaƮt.
Well, it was always going to come to this ā COVID vaccine talk is everywhere you look.
If you happen to have read Jeremy Knibbsās editorial for The Medical Republic a few weeks ago, youāll know Australia needs to hit a furious pace of 200,000 vaccinations/day to make the self-imposed October deadline (which the economy is hanging on), and every day we fall behind the required run rate goes up. The hustle is justified, but just as the dust was settling from 2020 and we were entering some form of normal, we now have to spring back into the best of pandemic traditions: uncertainty and rapid decision making.
Some of you might know that apart from being a rheumatologist Iām also a clinical pharmacologist, and in that role Iāve been involved with the vaccine (well, my teamās done the heavy lifting) ā in particular, designing a scalable implementation plan for vaccine cold chain and reconstitution for use by hospitals around the country for the Pfizer-BioNTech vaccine and its fickle -70Ā°C multi-dose vial current needs.
Itās been far more complex than I ever realised. While it seemed achievable enough at the beginning, itās challenging to design something:
(a) that everyone in diverse situations can use on aggressive scale, but with sufficient detail to actually be useful
(b) in a high-scrutiny, high-complexity space, extrapolating the limited available information with only ill-fitting precedents
(c) that fits into the demands of multiple layers of governance, each of which is understandably concerned about the domains theyāre responsible for, but none of which have the capacity to provide the detail to make it happen
(d) happens far too quickly.
So itās probably predictable that I feel a little bit sympathetic to the plight of guideline writers in the rheumatic disease COVID-19 vaccine space.
In the next few months, all of our patients will be offered the vaccine, and almost all of them who accept it will care about meaningful protection. How do we optimise this, while keeping our patientsā disease under control, our patients away from confusion and belief in the vaccine high without calling every patient to tell them what to do? Itās essentially impossible to get right.
Try writing some guidelines for everyone, in every situation, under intense scrutiny, with no direct evidence, that fits into all governance structures, and do it yesterday, s’il vous plaĆ®t.
Weāve recently seen the first version of the ACR guidance released, on the background of BSR and ARA guidance, and it evoked a few grumblings which were perhaps inevitable. While no-one really questioned the rituximab guidance, the questions flew quickly: why pick on methotrexate and why one week, why the trickery around abatacept for the first vaccine dose and not the second, why shouldnāt we test for antibody response to know if itās worked, and how would any of this work in practice anyway?
Well, to its credit, the ACR came out and talked through its guidance, and really explained the process (as rigorous as practicably possible) and the thinking (which helped some things make sense). More than that though, a few points about this situation are worth considering:
- I donāt actually know best. I am not a rheumatic disease vaccine specialist; I donāt have the sophistication of one, I donāt have the balance of a group of them in a consensus building exercise, and I definitely donāt have the time to go through all the data. If I can option out some of the thinking on this to smart people who are specifically much smarter about these things than I am, and get their considered advice, Iāll always take that over my corridor guesswork.
- What are guidelines anyway? Itās not meant to be a cookbook, and I never follow the recipes exactly anyway (more salt, more garlic, I try to skimp on the butter but it never tastes as good). Itās not meant to be a legal demand; the documents make that clear. Theyāre just general suggestions to try and drape across the elaborate topography of our patientsā clinical situations.
- These are āliving guidelinesā, based on what we know in a rapidly moving space. We need something now, we need to tell our patients something very soon, and to have a structured process where thatās updated as things happen is a genuine blessing.
- Don’t we agree on the most important things anyway ā that our patients should definitely get vaccinated? Who said we’ve got nothing in common?
- If things arenāt exactly how we think they should be, how should we feel about that? The COVID era necessitates a certain level of generosity of spirit; isnāt this the time for it?
Personally, and this is just my opinion: I think we should cut the authors some slack and just be a little bit grateful for putting in the hard yards and getting something out. And maybe even thank them.
As Wesley Snipes said in that early 1990s bedrock American movie, New Jack City: I wouldnāt wanna be ya.
Different opinion? Let us know in the comments or by writing to david@medicalrepublic.com.au