FDA Approves Wegovy for Heart Conditions in Game-Changing Move | Hacker News Reader

FDA Approves Wegovy for Heart Conditions in Game-Changing Move

sciencealert.com

11 pointsBrajeshwar25 comments

GLP1 Receptor Agonists[0] are going to change a LOT of things going forward. If we're having problems with price & accessibility now, I hope that gets solved before some of this stuff goes full swing.

That said, Wegovy is made by Novo Nordisk, and there are quite a lot of other drugs that likely have the same general effect:

- Ozempic

- Rybelsus (this is a pill)

- Mounjaro (different formulation, Tirzepatide)

- Zepbound

The FDA of course hasn't approved any of these other medications for this outcome but I'm betting that they're all circling the same abilities.

[0]: https://glp1.guide/content/what-are-glp1-agonists

I used saxenda, and now mounjaro - I've always struggled with food noise and I don't think many non obese people are aware of how life consuming this is.

All I used to do was wake up and wonder what food I was going to have, when I was going to have it, how much. It's like that ruminating voice in your head when you're depressed - it's just there all the time constant.

On these drugs it's just not.

> I used saxenda, and now mounjaro - I've always struggled with food noise and I don't think many non obese people are aware of how life consuming this is.

Any reason you moved between these in particular? Victoza/Saxenda have had some weird side effects that are not quite shared with semaglutide/tirzepatide I've seen in the past.

> All I used to do was wake up and wonder what food I was going to have, when I was going to have it, how much. It's like that ruminating voice in your head when you're depressed - it's just there all the time constant.

Thanks for this insight into what food noise is like

I wonder what the mechanism of action is that's preventing those deaths, or is it just increased weight loss?

From the article, it sounds like the weight loss, which leads to lower blood pressure. The approval is only for people with heart conditions AND obesity/overweight, not only a heart condition.

The reason I asked is because this sounds like non-news. Like wasn't this the main benefit listed in the pharmaceutical review - reduction in vascular events/mortality by reducing weight? I was wondering if this was new research that showed an additional 20% reduction in groups with similar weight loss.

I think the "heart condition" language is now explicit. The previous FDA approval[1] was for "management of obesity and at least one weight-treated condition"

1 - https://www.fda.gov/news-events/press-announcements/fda-appr...

To be fair, even "just increased weight loss" would be huge, obesity is a factor in so many causes of preventable deaths bringing people closer to a healthy weight would help a lot.

I heard a wild, unsubstantiated take on a podcast the other day, that effectively went like this:

with all of these proven weight loss drugs, the government should be mandated to have them prescribed free of charge to the consumer (IE, either the government pays or insurance pays), because if you look at the cost of obesity related illnesses / complications vs the cost of the drugs, the drugs will cost less.

I have no idea if that ends up being true (it feels right but doesn't mean it is right, at least in current pricing mechanisms) but I agree with the sentiment. This is a class of drug that could dramatically alter society for the better and it should be covered akin to how vaccines are covered.

EDIT: I'm not one to respond to comments via an edit, but I feel like everyone missed what I said here: I agree with the sentiment, and I think drugs like this should be covered in the same class as vaccines (e.g. how its a net good for society to have it generally available to those in need). I didn't say we should carte blanche cover them in the manner that was suggested, merely, I understand the sentiment, and the government, much like it has with vaccinations, should do what it can to make them generally available to those who need them and lower the cost.

By the same logic, one could argue that the government should ban fried foods, as the lost profits to the food industry would be outweighed by the medical benefits.

I don’t agree with that line of thinking.

Hard to see the math working out. 70% of Americans are overweight. Wegovy costs are about $12,000 and the average household income is like $70k. We are talking about half the federal budget spending on wegovy

Only because BigPharma uses the US to reap massive profits.

EU pricing is more like $200-$300/month.

Sure, but we are talking about the US. If we are thinking outside the box, anything is possible. The US government could negotiate in bulk, licenses the IP, or even go in with the army and comandeer the factory and scientists.

I don't think it needs to go that far -- one of the effects of capitalism is indeed competition-induced reduction of prices. Pharma is a bit different, but with time prices should go down and availability should go up.

Also note that the battle of insurance coverage of the drug is raging -- many do not pay retail for the drug, and Wegovy improving heart conditions opens up another path to needing to be covered by insurers.

On the fringes, I read (can't remember where) that some other large pharmas in the US are working on their own formulations that trigger GLP1, and abroad India and China have taken an interest (there are quite a few Chinese research papers floating around on the effects).

The US Semaglutide patent ends in 2 years, it is cheap and can already be bought in bulk. There is absolutely no reason for it to be expensive apart from the broken US medical system.

I'm pretty sure the most profitable course of action is just to let those who are obese suffer and die from the consequences. As ever, mixing human morbidity and mortality with a profit incentive gets macabre fast.

I agree, but that was the whole premise of the drug's approval. So I was wondering if this was some additional benefit, like if two groups of people were losing the same amount of weight somehow the group drug saw an additional benefit.

Unfortunately the paper with the results related to cardiovascular outcomes isn't open access: https://www.nejm.org/doi/10.1056/NEJMoa2307563?url_ver=Z39.8...

There's another open access paper just talking about the weight loss results.

The open access paper describing the design does discuss some other mechanisms by which it could improve cardiovascular outcomes: https://www.sciencedirect.com/science/article/pii/S000287032...

Since one of the outcomes measured was weight loss, perhaps the non-open access paper has information on how much of the improvement was mediated by weight loss if anyone has access to it?

In short, it’s a reduction in atherosclerosis associated with obesity and metabolic disorders. In obese people with insulin resistance, some actual fat cells will become “overfilled” with fatty acids and burst. This releases fats into the bloodstream and also releases inflammatory chemicals called cytokines. This is the process by which people get fatty liver disease. Both the fatty acids and the cytokines contribute to atherosclerosis, or hardening of the arteries. Causing a reduction in fat mass reduces the rate at which these cells burst and the associated coronary events, but it does not “fix” the arteries if they’re already damaged.

Ah, interesting. Thanks!

I think modern diets are quite damaging, even stereotypically 'healthy diets' that don't incorporate regular fasting. I've tried low doses of semaglutide and the effect to me feels very similar to fasting without the strong hunger cravings.

I know people are worried about the 'something for nothing' aspect of the medication and wonder what the cost is, but it's entirely possible, and I think probable, that the mechanism for action is reversing some of the damage of modern diets. I also think it's important to use semaglutide as a fasting aid and not as a cure all that would enable continuations of bad habits.

Were you on Rybelsus? I think that one has one of the biggest potentials to be really widespread in use. It's a low dosage (which looks high just because you lose so much of it in your body) -- pills are easy to take.

The costs are very well known (about as well known as ever for any pharmacological weight loss option) -- GLP1 RAs don't work for everyone, and they cause gastro-intestinal issues and can have other complications.

They're actually quite amazing (well I might be biased, I spend a lot of time looking them up).

I buy the semaglutide as a research peptide and manage my own dosing based on symptoms and ended up at 0.25mg per week which is a low dose but also makes it very cheap. I appear to be much more sensitive than most and I consider it a very strong drug. I was researching it for personal use before the ozempic craze but it was hard to get dosing and safety data - additionally if I had worrisome complications it would be hard to find a doctor that understood the medication. Now those issues have been fixed. I think more people would benefit from much lower doses for longer - alongside diet and lifestyle changes. Chronic GI issues are definitely something that should be avoided and I think lower dosing helps with that.

I think this is one of the reasons that Rybelsus will do really well. It ends up being quite a low dose because of how much of it is lost in the ingestion process, but a pill is certainly much easier.

> Chronic GI issues are definitely something that should be avoided and I think lower dosing helps with that.

This simple/obvious take is really quite often left out of the common objections to the drug on side-effect grounds. I wasn't sure it was necessarily true but it certainly makes intuitive sense -- if you're having a strong reaction, take a lower dose and plan your weight loss around that.

Yeah, quite a lot is lost via oral, I do worry with the dosing being uncertain with different stomach conditions resulting in different effective doses. Due to the cost savings I'll stick with injecting but totally understand that most people are adverse to that.

Permanent gastroparesis is nightmare fuel and I worry about people assuming ozempic a safe drug and being cavalier with the higher doses. There is a risk/trust dynamic between doctors and patients where doctors want to keep doses on the 'known path' and patients trust their doctors a bit too much.

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