Showing posts with label health. Show all posts
Showing posts with label health. Show all posts

Tuesday, 21 April 2026

Medsafe Delenda Est

Excellent news out of the UK. Abrysvo, a vaccine for RSV administered to pregnant women, reduces infant hospitalisation by 80%. 

From the BBC:

A vaccine during pregnancy which protects newborns against nasty chest infections is cutting hospital admissions of babies by more than 80%, UK health officials say.

A virus, called RSV, affects many babies in the first few months of life and can leave them gasping for breath and struggling to feed, with more than 20,000 babies ending up seriously ill in hospital in the UK every year.

Since 2024, women have been offered a vaccine from 28 weeks of pregnancy to protect their newborns.

A new study analysing the impact of the vaccine shows it gives "excellent protection" to babies when they are most vulnerable to RSV, the UK Health Security Agency (UKHSA) says.

RSV (respiratory syncytial virus) is one of the main reasons young babies are admitted to hospital before the age of one.

The UK govt website provides a few more details (alas, the link to the paper is broken).

The vaccine here is going to have been Abrysvo; it's the one that England rolled out against RSV.

Last year, I noted Abrysvo in a Post column on the proposed Medicines Amendment Bill. 

I'd written:

New medicines are slow to be authorised for the New Zealand market.

Even if it a medicine has already been approved by many other trustworthy overseas regulators like those in Canada, the UK, Australia and the EU, Medsafe can take a very long time to evaluate a medicine.

But pharmaceutical companies are not quick to get their medicines into our approval process. New Zealand is a tiny market. We are not at the top of anyone’s priority list. Medsafe will not assess a medicine without an application.

Consider RSV – the respiratory virus whose name is utterly unpronounceable when it isn’t an acronym. It is highly contagious. Pregnant women, infants, and some young children are more at risk from it – at least according to the Immunisation Advisory Centre.

Vaccination against RSV is available for New Zealand’s elderly. But while 40 other countries allow access to Abrysvo, a vaccine administered to pregnant women to protect their infants, Medsafe’s database shows no evidence that its manufacturer has applied for New Zealand approval.

New Zealand researchers helped with the clinical trials that proved its safety and effectiveness. But the vaccine is not available here. Simply being good enough for 40 other countries and tested here isn’t sufficient.

I noted that the Bill's proposed fast-track approval process for medicines wasn't what had been promised in the Coalition agreements. Those promised automatic approval if at least two trusted overseas regulators had approved a medicine - regardless of whether anyone got around to applying for Medsafe authorisation. 

And I worried that the fast-track would not solve the problem if the underlying problem is pharma companies not seeing NZ approval as being worth the time. We're an afterthought. 

The FDA and EMA authorised Abrysvo in pregnancy, to protect infants against RSV, in 2023. 

When I made my submission on the bill last year, a search of the Medsafe database showed no evidence that application for NZ approval had been made. 

As of this afternoon, the same search yields the same result. 

If you're pregnant or are thinking of becoming pregnant, talk to your GP about s29 access to Abrysvo. It might be tough. There might not be anyone importing it. And a lot of doctors don't like using s29. 

It is approved in Australia. I don't know whether Australian doctors are willing to dispense for Kiwis willing to pay. 

This is so stupid. 

Medsafe authorisation stands between pregnant women and this vaccine, approved in dozens of countries, and well-proven in the UK. 

Fingers crossed that Pfizer is just holding off until the 'fast-track' verification process is live, and that it goes live fairly soon. 

A closing snippet from the BBC piece. Delays can be costly. 

The vaccine didn't come in time for Laine Lewis's son Malachi, now 12 years old. He developed a cold as a baby which deteriorated so much that he was taken to hospital, diagnosed with RSV and put on oxygen. Malachi later stopped breathing and a scan soon after revealed brain damage.

His mum has said it's important his story "doesn't scare people" because what happened to Malachi was very rare.

But she added: "I'd encourage people to take the vaccine for RSV because it will help their child."

Dr Watson said the vaccine could "make a big difference to keeping babies safe" through the winter.

"I would strongly encourage any pregnant woman to discuss it with their midwife, other health professionals, and be ready to have the vaccine at their week 28 appointment, or another vaccine appointment arranged soon after that."

Latest figures show around 64% of pregnant women in England are getting the RSV vaccine, but that falls to 53% in London.

Addendum: Nothing here argues a case for government funding. That would require its own more rigorous case. I do not know why anyone would read the above as arguing a case for funding. It is only arguing a case for authorisation, so those willing to pay can have that's choice, whether or not it would be sufficiently cost-effective to warrant funding. And remember that some medicines get pulled from Pharmac's evaluation queue for want of a NZ sponsor for Medsafe authorisation. 

Wednesday, 24 April 2024

Afternoon roundup

A closing of some of the tabs

First, a set from closing a pile of the week's accumulated stories from the Stuff papers. I wonder whether the people who complain about the absence of real journalism bother reading what The Post and Sunday Star Times have been putting out lately. 

And the rest of the tabs. Or some of the rest. I'm drowning here but the computer needs to be rebooted.... 

Thursday, 16 November 2023

Afternoon roundup

The tabs!

Friday, 6 October 2023

The only thing you'll be nursing is your whisky

Either New Zealand has no shortage of nurses, or New Zealand is a fundamentally silly country. 

Look on, ye voters, and despair. 

A new nurses' training school is ready to train, but has to sit empty. Why?

Here's the bit in BusinessDesk: 

Instead, bureaucracy and an absence of pragmatism is coming before both the pressing workforce crisis and urgent patient needs.  

The delays all come down to an historic technicality requiring education providers to offer a Bachelor of Nursing programme before they can offer an Enrolled Nursing programme.  Yet enrolled nurses trained by UP Education in Australia are able to live and work in NZ using this exact diploma. 

They’re high-quality nurses who make essential contributions in hospitals, private practices and aged-care facilities. 

Let’s repeat that. This qualification is a cornerstone of the Australian healthcare system. Those who hold it can work immediately in the NZ healthcare system. Yet it is not allowed to be taught as a standalone qualification in this country.  

This outdated standard is likely why the NCNZ, the nurse training regulator, originally agreed to consult with its members on the removal of this standard.  

However, the NCNZ has since decided to bundle this specific review of a single technical clause into a much wider review of sector-wide nursing competencies across the country’s entire nurse training sector – for enrolled and registered nurses. A technical standard that could have been reviewed and removed in a matter of weeks has snowballed into a review requiring consultation across the whole health sector beginning late this year or early 2024, potentially delaying our nursing programme a further 12 to 18 months. 

Newsroom covers it too:

Rivera said she had been told the registered and enrolled nursing scopes would be wrapped together from early 2024.

“Then there’s the consultation on what the actual education standards might look like, so I said to [Nursing Council chief executive Catherine Byrne] that this sounds to me like a 12-18-month delay.

“I didn’t get a reply, but that is my assumption given how consultation processes work with the Nursing Council.”

At the extreme end, Rivera’s estimated timeline could push the opening schedule to early 2025.

The facility, which got $370,000 in taxpayer funding through the Tertiary Education Committee, will sit empty until the consultation comes to an end.

“I have staff hired and ready to go, but luckily we're quite nimble and I've got them working on other health qualifications, so they are doing other things.

“The broader issue is we thought we could be part of a solution to a problem, and the bureaucracy around it is astonishing. There's just no movement.”

Rivera accepted the scope of practice needed to be looked at. “But it shouldn't mean that when there's a crisis, everything grinds to a halt and no new player is allowed in the market.”

 

Wednesday, 4 October 2023

Certified

If a drug or medical device has already gone through the regulatory gauntlet at the FDA and Australia, or in the UK and Canada, or the EU and Taiwan, or Switzerland and Singapore, does it seem all that likely that Medsafe's going to find anything that everyone else missed?

Sure, Medsafe has 'expedited' processes for drugs already approved elsewhere. But those processes still impose cost - particularly time cost on pharmaceutical companies' regulatory affairs teams. 

And five million middling-income people at the far end of the world just don't hit the priority queue.

Alex Tabarrok talks about the FDA's invisible graveyard: all the people it has killed by being too slow to approve safe and effective drugs. How should we think about New Zealand's, when New Zealand insists on running a separate process for drugs already approved elsewhere?

In August, Pharmac dropped a pile of drugs from funding evaluation. Why? In twenty-four cases, Pharmac said, "We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration."

The government here likes to say the problem is the pharmaceutical companies, and that Medsafe would be happy to process their applications if only they'd apply. The real problem is that we have this process at all for drugs already approved elsewhere.

ACT yesterday announced that it would require Medsafe to automatically approve any drug or device already approved by at least two other trustworthy regulators, unless Medsafe had extraordinary reason not to approve it. 

ACT says if a drug or medical device has been approved by any two reputable foreign regulatory bodies (such as Australia, United States, United Kingdom), it should be automatically approved in NZ as well within one week unless Medsafe can show extraordinary reason why it shouldn’t be. 

This simple change would significantly improve access to medicines that have already been subject to rigorous testing and analysis through other regulatory regimes.

The Strategy would include a working list of international regulatory regimes that have comparable or more robust systems compared with New Zealand. It will also include an analysis of areas where international analysis might not be directly relevant to the New Zealand population: for example, if there are significant differences in population makeup that would distort medical efficacy.

National's policy isn't far from that.

4.2 Faster approvals for new medicine

New Zealand’s slow approval process for medicines means Kiwis wait much longer than people in other countries to access potentially life-saving treatments. While it is essential that medicines and other treatments are subject to stringent scrutiny to ensure they are safe, there is no reason why New Zealanders should have to wait for our domestic medicines regulatory body, Medsafe, to conduct its own cumbersome process from scratch, when countries with health systems we trust have already gone through this exercise.

National will

  • Legislate to require Medsafe to make decisions on approval for registration for all medicines within a maximum 255 days, to align with Australia,
  • Require Medsafe to implement even faster approvals processes for any medicines for use in New Zealand that have already been approved by at least two regulatory bodies that we currently recognise, including Australia, the EU, Singapore, the UK, Switzerland and the US.

I've long wanted this kind of policy. And there's some hope that the general congruence of the two parties' policies could mean it gets done in the event of a National-ACT coalition.

Excellent.  

Tuesday, 3 October 2023

Afternoon roundup

The tabs...

Wednesday, 23 August 2023

Morning roundup

The morning's worthies:

Friday, 7 July 2023

Afternoon roundup

The tabs do pile up. A few days out at the NZAE meetings, a couple days leave, and then digging out from under the pile...

Wednesday, 19 April 2023

Afternoon roundup

The worthies, on the closing of the browser tabs

Wednesday, 15 March 2023

Afternoon roundup

It's been a while since last posting. The tabs...


Thursday, 23 February 2023

Afternoon roundup

Oh the tabs. 

Tuesday, 10 January 2023

Afternoon roundup

Easing back into the office after a summer break and already the tabs have multiplied.

Today's worthies:

Tuesday, 6 December 2022

Morning roundup

Another 'everything is stupid and broken' compilation from the closing of the browser tabs.

Friday, 25 November 2022

Afternoon roundup

The closing of the tabs:

Thursday, 3 November 2022

Life expectancy and health outcomes

There's a literature on everything, so I expect someone's already done this. I'd be keen to see the result if someone has.

There are almost-certainly piles of disorders that are particularly damaging when you're older rather than younger, and where there are apparent differences in effect by ethnicity after correcting for age. 

I know that the Ministry of Health here has pointed to differences in Covid outcomes by ethnicity in multivariate analysis correcting for age but there will have to be lots of other ones.

There are two ways of thinking about age. You can think about it as years since birth. Or you can think about it as percent of expected life expectancy already expended. Same as how you can think about your fuel tank as how many litres of fuel you've used since you filled up, or as what percentage of the tank is left. 

Suppose that life expectancy at time of first birthday varies by ethnicity for whatever mix of environmental and genetic reasons. Fuel tanks vary in size. If you're counting litres of fuel used since the tank was full, there will be very different amounts left in the tank depending on the car. 

And suppose further that the true effect of some disorder on health outcomes depends on your remaining life expectancy before the disorder hit rather than your time since birth. Basically anyone who's at 95% of their life expectancy is going to have a rougher time with the illness regardless of whether that 95% mark hits at age 67 or age 80. 

If that's the underlying process, if you run a regression with health outcomes on the left-hand side, and age-in-years and ethnicity on the right-hand side along with whether someone catches the disorder, you're going to lump effects into ethnicity that might not really belong there for this particular disorder. 

It'll be true that a greater proportion of people with this ethnicity at that age die of the disorder, but the ethnicity variable will be a mix of underlying differences in mortality risk by ethnicity plus disorder-specific risks.

I'm not trying to criticise the MoH work here. I'm just wondering where this kind of thing has been considered in the literature. Do age-ethnicity interaction terms sort it out by allowing the effect of age on health outcomes to vary by ethnicity? MoH throws in a "hospital-registered co-morbidity" variable that will catch some of the 'effectively old for physical age' effect but wouldn't get all of it.

I just keep remembering that old Robert Fogel work looking at the health status of US Civil War enlistees, where the 50-year-olds of the 1850s were hitting the health problems of today's 70-year-olds. It'd be true to say that 50-year-olds of that era were at far higher risk of dying from heart attacks. But they were also way closer to end of expected life expectancy. So it wasn't just that heart attacks were worse then - it was that life expectancy was lower, people effectively aged more quickly, and something like a heart attack is worse when you're more run down. 

Other not-so-fun bit from that old NYT piece on the Fogel work, that could also be relevant these days:

Dr. Almond had a problem with the studies. They were not of randomly selected populations, he said, making it hard to know if other factors had contributed to the health effects. He wanted to see a rigorous test — a sickness or a deprivation that affected everyone, rich and poor, educated and not, and then went away. Then he realized there had been such an event: the 1918 flu.

The flu pandemic arrived in the United States in October 1918 and was gone by January 1919, afflicting a third of the pregnant women in the United States. What happened to their children? Dr. Almond asked.

He compared two populations: those whose mothers were pregnant during the flu epidemic and those whose mothers were pregnant shortly before or shortly after the epidemic.

To his astonishment, Dr. Almond found that the children of women who were pregnant during the influenza epidemic had more illness, especially diabetes, for which the incidence was 20 percent higher by age 61. They also got less education — they were 15 percent less likely to graduate from high school. The men’s incomes were 5 percent to 7 percent lower, and the families were more likely to receive welfare.

The effects, Dr. Almond said, occurred in whites and nonwhites, in rich and poor, in men and women. He convinced himself, he said, that there was something to the Barker hypothesis.

Tuesday, 25 October 2022

Afternoon roundup

A closing of some of the browser tabs:

Wednesday, 20 July 2022

Evening roundup

I was out on leave last week, touring around Lake Taupo with the family, hoping desperately for snow that didn't come. 

We had fun anyway. 

But the browser tabs... a week's worth of emails, and stuff saved up... egads. 

Some worthies as I try to clear six different Chrome instances...

Monday, 4 July 2022

Afternoon roundup

Let's get these browser tabs back under control

Friday, 25 March 2022

The supply of specialists

Monday's column hit on regulatory barriers to entry in medicine that really look like cartel-enforcement mechanisms. Westpac had this note in 2016:

Industry sources had several concerns about competition or the lack thereof in provision of healthcare and social support services, and about differing standards set for public and privately contracted providers of these services. 

One of the chief concerns was the cost of specialist care in New Zealand relative to many other countries, and the incentives specialists had to work in private healthcare rather than public healthcare, which exacerbated the problem. Some laid the blame at the door of the specialist colleges, which set the standards required before a specialist could practice in New Zealand. 

While acknowledging the importance of ensuring standards were sufficient to keep patients safe, there was concern that colleges acted as gatekeepers to limit the supply of specialists in New Zealand. This all but guaranteed that those who made it through the process earned high salaries. This monopolistic supply (increasingly requiring a fellowship on top of other qualifications) was having such an effect that some thought New Zealand now had an oversupply of GPs. Many people went part way toward becoming specialist before dropping out because the requirements had just become too restrictive, even though they were capable of practising at specialist level. There were immediate impacts on public healthcare provision due to cost pressures and time delays, yet the DHBs we spoke to appeared to believe there was no way around this hurdle.

HT: David Norman 

Tuesday, 22 March 2022

Competition in accreditation and certification

James Hogan makes an excellent point on the doctor cartel. I'll quote it below, mildly edited to put the links in:

In this link, Specialists must work under supervision for six to 18 months are the magic words, "The relevant specialist medical colleges complete these assessments and provide advice to Council."

If the New Zealand Medical Council recognised multiple medical colleges as competent to supervise New Zealand's medical workforce within the same areas, then competition between those colleges seeking members in New Zealand would expand the number of supervisors available to train overseas graduates.

If say an organisation like, say, the Colleges of Medicine of South Africa could assess the competency of Anaesthetists for New Zealand and had the incentives to expand their services to New Zealand, then both they and the Australia and New Zealand College of Anaesthetists (which is the sole provider of assessment competency) would compete for members and expand training.

And they would also act as peer review bodies on the competency of the other organisation's training too, expanding both the number of trainees and quality of training.

It's a neat idea. 

James, who wrote his thesis under Seamus back in the day with mild ancillary support from me, was having some trouble getting this into Disqus. I'm going to have to find a day some time to fix this. I have been saying that for years though. Disqus isn't integrated into the mobile version. 

But whenever I start thinking about it, the project balloons. None of the blog formatting is right. And really, shouldn't it be a part of a bigger site with links through to all of my columns and reports and stuff? But there's just so much of that and it would be a big job. Or maybe it should all be a Substack; they'd sent an email encouraging me to flip to them. But how would that even work? And anything would wind up breaking links. 

And then the dread. And then I don't. 

James says I should just pay somebody to sort it all out. He could be right.