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Fred99

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#287147 9-Jun-2021 17:15
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https://www.cnbc.com/2021/06/08/biogen-faces-tough-questions-over-56k-a-year-price-of-newly-approved-alzheimers-drug.html

 

I assume that it may be a while (if ever) before this drug is approved in NZ, let alone a decision made on funding. 

 

From what I've read, there's considerable doubt whether the treatment works at all, it's expensive (US$56,000 per year) and it does have potentially serious side effects.

 

Yet anybody who's seen a loved one decline from Alzheimer's would probably want to try anything possible to delay what's inevitable - even if there's poor evidence it works and no evidence it's even close to being a "cure". 

 

 

In the first "EMERGE" trial, an analysis split by dose indicated that high doses reduced rate of decline by 23% versus placebo. A second identical trial "ENGAGE" failed to replicate this, with a non-significant 2% reduction in decline compared to placebo

 

 

This is going to put a lot of people in a terrible situation - actually worse than if the drug never existed. Sometimes I hate big Pharma - this isn't helping.

 

 

 

 


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gzt

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  #2721324 9-Jun-2021 18:02
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What was the size of each trial?

 
 
 

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Fred99

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  #2721333 9-Jun-2021 18:56
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gzt: What was the size of each trial?

 

About 1600 in each, one showing a mild reduction in decline, the other showing nothing.
I think the company provided additional data (not double blind trial) which showed a measurable reduction or slowing in beta amyloid plaque formation, but there's no hard evidence whether the plaque formation is causative (ie of cognitive decline) or a symptom of "something else" causing decline.

 

This is a result of Trump's loosening of requirements for FDA drug approval.  While it sounds great (on compassionate grounds - it "might work" and nothing else does) the reality is IMO somewhat different.  Firstly, medical treatments should be evidence based, and secondly, the burden of making a decision in these cases is probably going to left to family/carers (not patients who are cognitively impaired), facing a substantial cost, and inevitably feeling guilt if they don't cough up.  Costs over typical progress of the disease could be hundreds of thousands of dollars. If Biogen are so confident it works, then they should have sought limited approval and extended trials "free" for participants, until such time as they can monetise it based on evidence it actually works.

 

At the moment, I feel it's Biogen monetising something more like quackery or herbal remedies.  The difference with the herbal remedies is you can probably get them cheap, off patent, whatever.  You can't DIY monoclonal antibody therapies - so they've got people by the balls.

 

 

 

 


Batman
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  #2725096 11-Jun-2021 07:13
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No one has made any pill that cures anything.



throbb
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  #2725101 11-Jun-2021 07:50
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Batman: https://edition.cnn.com/2021/06/10/health/fda-adviser-resigns-alzheimers/index.html

 

 

 

Yeah read this this morning, just big Pharma cashing in again. Selling hope for big $$$. "Biogen, re-analyzed data and said there was an indication it might help some patients"

 

 

 

Saw Katie Porter grilling a CEO about prices of drugs and claim that the prices were high as it allowed for further R&D, when R&D is a small fraction of what they spend on enriching themselves.

 

 

 

 

 

 


Fred99

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  #2725151 11-Jun-2021 10:11
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Batman: No one has made any pill that cures anything.

 

Really?

 

So antibiotic tablets have never cured a bacterial infection, anthelmintics never cured a case of intestinal worms, oral antivirals don't cure some viral infections, vitamin C tablets wouldn't cure scurvy, whatever...

 

Sometimes your one-line comments don't make much sense.


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