The TGA has approved a drug — donanemab — to treat Alzheimer's disease in its early stages.
The drug has a small effect in slowing cognitive decline, however it isn't a cure and can have significant side effects.
Also, the World Health Assembly adopts historic Pandemic Agreement with zero objections.
'Norman Swan': Olivia, thanks for filling in again on the Health Report. How are you?
Olivia Willis: Norman, I'm well. But I've got to say, you don't sound quite like yourself.
'Norman Swan': I'm not sure what you mean, Olivia, I'm Norman Swan.
Norman Swan: He's not Norman Swan, don't believe a word of it, Olivia.
Olivia Willis: Oh, he nearly got me.
Norman Swan: Yeah, that was a deepfake audio of me, naughtily produced by Shelby, our producer.
Olivia Willis: So why are we doing deepfakes, Norman?
Norman Swan: Because I've been subjected to deepfake health scams where videos of me are being distributed on Facebook, where people like Rebel Wilson and Adele are recommending to the world that I've got the wisdom on weight loss and sometimes diabetes care, getting people to stop their medications. It's quite extraordinary.
Olivia Willis: Yikes.
Norman Swan: That's just part of what's coming up on the Health Report.
Olivia Willis: I'm Olivia Willis on Wurundjeri land.
'Norman Swan': And I'm Norman Swan on Gadigal land.
Norman Swan: Could you just get rid of this deepfake, I'm sick of him. I truly am Norman Swan on Gadigal land. Hope you're not confused.
Also on the show, President Biden has been diagnosed with aggressive prostate cancer. Why wasn't it picked up sooner?
Olivia Willis: A breakthrough using the gene editing technique CRISPR to treat a baby with a one-in-a-million disorder, and where to from here.
Norman Swan: And we're told we should be sleeping a magic eight hours a night to reap the health benefits, but a new study has found sleep duration varies across cultures, and a shorter sleep doesn't always mean worse health.
So let's get to some news.
Olivia Willis: Let's. So one thing that really caught my attention this week is the TGA has approved a drug to treat Alzheimer's disease. This drug is called donanemab, and clinical trials have shown that it can help in the early stages of the disease. But Norman, we know the evidence here maybe isn't super strong.
Norman Swan: So just a bit of background here. For years, there's been this theory that a substance called beta amyloid which forms plaques in the brain (so in other words, gunky material in the brain, outside the nerve cells of the brain) is the cause or a significant contributor to Alzheimer's disease. Billions of dollars have been spent on research, and as more and more research has been done, the theory has been undermined, and the major undermining has occurred because of just these drugs. So there's no question that if you've got Alzheimer's disease, one way it's diagnosed is by finding amyloid in the brain, and these days you can do brain scans which find that. But amyloid just might be a side effect of what's really going on inside the brain.
Olivia Willis: We also know that amyloid is in the brains of people who don't have Alzheimer's disease, right?
Norman Swan: That is right.
Olivia Willis: And there are people who have Alzheimer's who don't have amyloid.
Norman Swan: Or don't have much amyloid, and then there's another substance called tau that's involved. If amyloid was a significant cause of Alzheimer's disease, then you would expect that removing amyloid would actually contribute significantly to alleviating the condition. And you've got these amazing drugs, and donanemab is one of them, which can suck out amyloid from the brain. They're so effective that when you do brain scans and you've been on this drug for a while, there's almost no amyloid left in the brain. They're incredibly effective, so they do what's written on the packet. Now, the question is, does it help?
So there was another drug called lecanemab which had quite significant side effects. Donanemab has side effects too, you get little haemorrhages and swelling of the brain, but the donanemab seems to be a bit safer than lecanemab. So they tried these drugs with people with established Alzheimer's disease. It made almost no difference, and the argument was, well, it's too late, the damage is done. So what the trials have done is they have moved earlier and earlier and earlier in the process of developing Alzheimer's disease, to the stage that they're picking up people who are starting their journey in what's called cognitive decline. Their PET scan is showing beta amyloid in the brain, and then the randomised trials put them on this or placebo to see whether or not you got benefit. And sure enough, they remove amyloid, but the effects are minor.
Olivia Willis: In terms of cognitive function?
Norman Swan: Yeah, if beta amyloid was the main game here in Alzheimer's disease, you would see dramatic effects on the decline in dementia, and you're not. They do seem to change the course of the disease, but not in a major way. And what you've got here in Australia now is that the Therapeutic Goods Administration has approved the drug for use in Australia, so that allows the drug company to market the drug in Australia, but there's no subsidy on the Pharmaceutical Benefits Scheme. So if you want this drug, it either has to be provided through a hospital, where the hospital pays for it, or you pay for it yourself.
Olivia Willis: It's about $40,000 to $80,000 a year to administer.
Norman Swan: They are expensive.
Olivia Willis: And on the PBS listing, I believe that it will be reviewed in July, whether it will be subsidised. So, we'll have more news then.
Norman Swan: Yeah, I don't envy them the task. It's an expensive drug with questionable benefits, and how do you cost that? And they have those health economics analyses that allow them to do that, but there'll be enormous pressure from lobbyists to approve that for subsidy.
Olivia Willis: In other big news this week, Norman, members of the World Health Organisation adopted a global pandemic accord to essentially improve our global preparedness for future pandemics. This is a big announcement in global health news.
Norman Swan: And it's been a long time coming.
Olivia Willis: It has. I believe there were about two or three years of quite difficult negotiations around what this would mean for the members who signed on to this. It obviously comes in the wake of the Covid pandemic where it became really, really apparent that there were huge inequities in the distribution of vaccines and therapeutics between high-income nations, low-income countries, and we certainly had problems around higher income countries really hoarding vaccines and that creating huge inequities globally. Do we know what it means now that this has been agreed upon and adopted?
Norman Swan: My understanding of it is that a lot of it is about Western countries, richer countries, and the companies which produce, say, vaccines and therapeutics, accepting that they'll make their money out of those richer countries, and they will give these drugs and vaccines either at extreme discounts or free (those details have got to be fleshed out) to low- and middle-income countries.
What was unusual about this is nobody voted against. It has to be said that the United States wasn't there because they've left the World Health Organisation, but 124 countries voted in favour, and 11 abstained. So this is an extraordinary vote of confidence in this. But as with a lot of these accords, the devil will be in the detail.
And yet more news about vaccines from the United States, this time about Covid vaccines from one of the new appointees in the Trump administration, in the Department of Health and Human Services.
Olivia Willis: That's right, they're going to limit access to Covid vaccines going forward. They'll be all limited basically to Americans who are 65 and older, and Americans who are otherwise at higher risk of becoming seriously ill from Covid, so those with underlying conditions and other risk factors. And the FDA now says that it's going to require additional scientific studies before it approves booster shots for healthy people, so people under the age of 65.
Norman Swan: And the interesting thing about this is that they've bypassed the normal vaccine advice and approval process.
Olivia Willis: They have. So the changes come at the direction, as you say, of newly appointed FDA officials appointed by Donald Trump, who have basically said that they think the benefit of booster doses for young and middle-aged people are uncertain. That's why they want more evidence around what the benefits are for that kind of healthier group of people. But it definitely marks a departure from previous US policy, which essentially recommended annual Covid boosters to everyone over the age of six months. And I think what's interesting is this actually brings the US a bit more in line with our booster recommendations.
Norman Swan: It does, but it's optional for people at low risk in Australia, but you will still be covered by government subsidies, you won't have to pay for it.
Olivia Willis: That's right, in the US this will actually make it that you're not able to get a Covid vaccine if you want one, unless you fit that eligibility criteria, and the people who fit that eligibility criteria, it's still something in the order of I think 30% of US citizens. So there's still a huge number of people that will be covered, but it does change things for people who aren't necessarily high risk but want to protect themselves.