Tuesday 21 December 2021

Medsafe Delenda Est?

Medsafe finally signed off on the Pfizer vaccine for 5-11 year olds.

Approval really was a forgone conclusion. It had been approved by the US, Canada, Israel, and others weeks or months ago. The odds that Medsafe was going to find something that bigger and better-resourced agencies hadn't found were close to nil. The only thing Medsafe provided was further delay in getting kids vaccinated, and Omicron is banging at the door. 

Over in the Dom (and the other Stuff papers), I wondered whether we need Medsafe at all. We could replace their approval process with a simple rule: if at least two trusted regulators abroad have approved something, we approve it automatically. 

I don't know what Medsafe adds after it's been approved in two places. 

Alternatively, rather than replace Medsafe entirely, you could augment it. Keep Medsafe on the off chance that somebody wants to work an approval through our system before others. But set a rule that, if a drug has been approved by two trusted regulators, Medsafe must follow suit immediately or provide exceptional justification as to why delay is warranted in this particular case.

I wrote:
Now imagine that Medsafe had never existed. New Zealand could rely on approvals provided by trusted regulators elsewhere.

If at least two of Australia, Canada, the United States, the UK, Singapore, the European Union, Israel, Switzerland or Japan approved a drug, it would automatically be approved here too. There are a lot of approval agencies out there. New Zealand would never be slower than the second-slowest trusted agency.

Why replicate the efforts of better resourced agencies elsewhere who are already on the task?

There could be a good reason.

If international regulators err on the side of being too slow, a New Zealand agency could be faster and nimbler than others. Where other agencies harm their public by taking too long to approve drugs, ours could avoid such errors.

That does not seem to be the role Medsafe plays.

Instead, Medsafe adds further delay on top of delays seen abroad.

Delayed approvals put us at the back of procurement queues for effective Covid treatments that will be in high demand. Those treatments keep patients out of scarce intensive care beds. Delays will matter.

Former head of the Salaried Medical Professionals Ian Powell gives the standard establishment line in response with a piece in BusinessDesk.  

My column began by noting that agencies optimally balance two risks. If they just approved everything, some bad drugs would get through despite pharmaceutical companies' reputational incentives to avoid that. I wrote:

Pharmaceutical companies have strong reputational reasons to avoid releasing unsafe drugs – not to mention liability concerns in some jurisdictions.

But an approval agency that simply rubber-stamped every application it received would risk approving a lot of unsafe drugs. And some people would be hurt or die as consequence.

That was the one polar extreme. The other is the agency that takes half a century to approve anything. No bad drugs get through, but a lot of people are harmed through treatment denied. 

I wrote:

But you could also imagine an agency that took half a century to approve any application. No drug would be approved unless the agency could determine, with certainty, that no adverse effects were encountered for decades after taking a drug.

So of course Powell chooses to pretend that my first polar case is actually me arguing for complete deregulation. Here's Powell:

I don’t know whether Crampton is familiar with Victorian satire but, if he is, he may have had the Charles Dickens novel ‘Bleak House’ in mind. In particular, the fictional Jarndyce and Jarndyce probate case progressing in the English Court of Chancery. The case has become a byword for seemingly interminable legal proceedings. The closest Crampton gets to satire is his metaphoric use of “half a century” to describe Medsafe’s approval process.

In the context of extending Pfizer coverage to children over five years, Crampton argued the pharmaceutical companies had sufficient motivation to give confidence over safety. He is right to the extent that it is not in the interest of pharmaceutical companies to intentionally or otherwise produce ineffective or dangerous vaccines. At the very least the reputational damage would be bad for business. Similarly, it is counter-intuitive for them not to employ competent scientists.

But these companies are driven by profit-maximisation. Not just profitability. They are a risky fit for the provision of a universal public good such as vaccines. Until the current coronavirus pandemic this meant their vaccine research and development was a lower investment priority. However, the pandemic generated a new lucrative market opportunity. Unfortunately profit-maximisation creates opportunities for standards and carefulness to slide.

I guess I must be worse at writing clearly than I'd thought because Powell completely failed to understand what I was getting at, or pretends not to. 

I was saying that agencies' processes can lie on a continuum from "approve everything" to "take half a century to approve anything". In the former case you get harms from drugs being released that shouldn't have been approved but no harms from delays; in the latter case you get zero harms from bad drugs being released but lots of harms from delayed access. The trick is finding processes that minimise the sum of those harms. 

Powell goes on to provide some examples of one agency or another getting things wrong. Fortunately, I did not suggest "Approve anything the FDA approves." I suggested automatically approving if two other agencies had approved. 

But he gives a great example of how medical types think about this stuff. Harms from delay seem not to factor into his thinking.

Crampton could not be more wrong. Medsafe should take as long as is needed before approving a vaccine application because the risk of harm to the innocent is too great. Efficacy is important. However, relying on what the results of clinical trials reveal or what other regulatory authorities in a small number of ‘approved’ countries decide is insufficient when there is an opportunity to drill down further.

I view a death or harm caused by releasing a drug that shouldn't have been released (in some perfect-omniscience world) as being just as bad as a death or harm caused by delaying a drug or treatment. But for people like Powell, only one kind of harm exists. Unfortunately, they're the exact kind of people who set the system and processes here, resulting in futile harmful delay. They're the reason we need a rule requiring approval of drugs approved elsewhere, and they're also the reason we won't get that kind of rule. 

"As long as it takes" is the wrong standard. "Investigate until another day's worth of process results in as many expected reduced harms from the drug as expected increased harms from delayed access" is the better standard. 

What would have been a first-best with kid-vax, where popular acceptance is a factor and where people here put some value on Medsafe that I don't? Simple. Allow the vanguard of the willing to be vaccinated early, while holding the broad rollout until Medsafe had done it's useless-but-for-building-public-confidence thing. There was a non-crazy case for saving the big rollout until a couple weeks of US and Canadian data showed that kids weren't having a pile of adverse reactions. That would have had rollout of first doses at school before the end of the school year. But we're having to wait for freaking January now. 

And I note, not for the first time, that neither Covid Classic, nor Delta, nor Omicron, had to pass any MedSafe approval process to be allowed to infect children. They could just go ahead and do it, without any clinical trial or assessment of potential long-term harm. 

1 comment:

  1. Urgg... Anybody who argues by analogy citing Dickens and Oscar Wilde needs to take a course in plain English writing and drop their "aires and graces" and illusions that they're well read and intellectual.