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And that's exactly why it should not be approved. There is no proof there is ANY effect on the disease outcome. The trial was halted prematurely for futility ff
by markus92 5y ago
And that's exactly why it should not be approved. There is no proof there is ANY effect on the disease outcome. The trial was halted prematurely for futility ffs! And now the FDA is giving people false hope? Letting them spend $65k/year for possible snake oil with no scientific evidence behind it?
Alzheimer's is a terrible disease. And I get it, you're willing to try anything for a possible improvement. Problem is, there is no proof at all that aducanumab leads to any kind of improvement: only stuff that you might find if you do tons of data mining to get the result you want. If the drug was that good, you would find it each and every time you try it, not one out of a hundred times if you look at a subset of a subset.
The only reason the Biogen wants approval of this drug, is to earn money out of desperate people willing to try anything. The FDA should be there to protect people from this. They have failed to do that here.
- saas_sam 5y agoIf you are against desperate people buying drugs to solve their problems and as such the government should work to keep drugs away from people... tell me, are you an avid supporter of the War on Drugs as well? I hope I don't see any comments by markus92 on future threads advocating for drug legalization, or an easing of restrictions on recreational drugs, or an easing of punishments for drug abuse. Because to say that I don't have the right to try a drug after careful consideration with medical professionals -- DOCTORS -- to potentially help alleviate my dying mother's illness... while any junkie on the street is entitled to getting high on whatever pharmaceutical they can get their hands on. Is morally repugnant.
- bitshiftfaced 5y agoThe FDA doesn't prevent people from taking herbal supplements, given the supplement doesn't make misleading claims. Assuming this drug doesn't make misleading claims about the evidence for its effectiveness, why should the FDA prevent its sale?
- danso 5y agoHerbal supplements aren't considered drugs by the FDA, and thus are regulated under a different set of rules. What you asked makes as much sense as, "Why won't my doctor prescribe me a breakfast of steak and eggs?"
- bitshiftfaced 5y agoSay a breakfast of steak and eggs was classified as a drug, and it wasn't shown in a clinical setting to be effective in treating Alzheimer's. A doctor wants to prescribe it to a patient, even though the patient and doctor both know about the trials and evidence. Why should the FDA prevent the doctor from prescribing steak and eggs for breakfast? Edit: I ask this because my understanding is that the FDA is supposed to make sure drugs are safe and also to oversee drugs of abuse. If a drug is deemed safe and isn't one that's likely to be abused, I don't understand why it's within the FDA's domain to tell a doctor whether they can prescribe it.
- markus92 5y agoThat would be considered off-label prescription.
- bitshiftfaced 5y agoWhich is commonly done, and legal, right?
- danso 5y agoYes, doctors can prescribe off-label uses for basically any already approved drug. I'm not sure how it would apply to Aduhelm, which AFAICT has no indicated uses other than Alzheimer's. But let's assume there is no legal barrier to the doctor prescribing Aduhelm, and somehow you've found a doctor who is going to against the status quo based on inconclusive studies. Which insurers are covering it (certainly not Medicaid or Medicare)? Which pharmacy is stocking it? And where are they getting their supply? Biogen? You think Biogen's lawyers and executives are going to accept high legal exposure (e.g. consumer lawsuits) for an infinitesimally small market? FDA approval provides a legal and market framework for drugs to be supplied, marketed, and paid for. If your friend who runs Biogen has a spare box of Aduhelm and gifts it to you, it wouldn't be the FDAs problem.
- usefulcat 5y agoThe difference is that insurance doesn't cover herbal supplements, so their cost isn't socialized. If insurance covers this treatment, then by extension everyone who has insurance has no choice but to pay for it.
- bitshiftfaced 5y agoThat's true of some drugs anyway, especially newer ones where the effectiveness isn't as well studied.
- hackinthebochs 5y ago>Problem is, there is no proof at all that aducanumab leads to any kind of improvement Nothing you have said has any bearing on whether someone who is currently dying of Alzheimers should be allowed to try it if they or their doctors or family choose. "False hope" is not the most important thing at stake here, not by a long shot.
- mcguire 5y agoCommitting fraud against the most desperate, vulnerable people in the country is universally regarded as unethical.
- hackinthebochs 5y agoBut there is no fraud. As has been stated elsewhere in this thread, the drug claims to remove plaque, not to treat Alzheimers. I personally don't have the hubris to think I should stand in the way of someone willing to try the drug on their loved one who is suffering from Alzheimers.
- bingidingi 5y agoThis is an incredibly expensive treatment meant for incredibly desperate people. If you were in a situation where a parent had alzheimers it would be hard not to feel guilty if you didn't try it, no matter the price. To approve the drug despite the lack of efficacy is unethical, especially considering there are potentially severe side effects like brain swelling.
- paulpauper 5y agoexcept that financial resources are finite . Without certain standards, costs would spiral out of control more than they already have.
- hackinthebochs 5y agoI am sympathetic to the argument that expensive treatments socialized medicine pays for should be limited to those proven effective. What I am against are blanket restrictions presumably for people's own good, or to prevent "Big Pharma" from profiting or whatever bugaboo it is.