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.

The 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?

Herbal 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?"

>Herbal supplements aren't considered drugs by the FDA

And what is considered a drug or not is at the discretion of the FDA and other agencies. This is a choice they make not to regulate supplements like drugs. This fact has no bearing on what level of regulation is appropriate for a given chemical. Don't avoid the meaningful discussion by citing trivia.

See my reply further down the thread: https://news.ycombinator.com/item?id=27475833

You're right the FDA decides those categories. But Biogen is the one that created the compound and is pitching it as a drug, when they could've sold it as a nutritional supplement. Why exactly do you think they did that?

Say 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.

I think my comparison was too absurd/convoluted, because you're still making the same fundamental categorical mistake of asking "Why can't [X] be treated as [Y]?", as if "food" and "drugs" are just synonyms, and not separate categories with different rules and preconditions. But in any case, in a universe where "steak and eggs" were classified as a drug, and have also been commonly sold over-the-counter (i.e. at your local diner, without needing a doctor prescription), then nothing would prevent your doctor from prescribing "steak and eggs" for Alzheimers. And in our current universe, nothing stops your doctor from prescribing Viagra or Tylenol to treat Alzheimer's, even though none of those drugs have been approved by the FDA for that specific use. Doctors have a lot of freedom to use their judgment in prescribing off-label uses. So it's not a question of "Why can't doctors prescribe steak and eggs/Viagra/Tylenol" for my Alzheimer's — it's "Why won't...?", which I think the answer is mostly self-evident.

So why can't Aduhelm be treated like an OTC herbal supplement? Well for starters, because Biogen didn't research and develop it with the intention of marketing it as a herbal supplement. So I think the answers to your question are very much related to the answer to "Why doesn't Biogen release Aduhelm as a herbal supplement?"

Obviously we can dodge the question of "Why can't [X] be treated as [Y]?" by saying "X is not Y", as you've done. If you ignore the point behind the comparison, and we say that "X is X", then there is no argument. Biogen still has time to do the trial to show effectiveness and is going through a process that is governed by the set of rules set forth for drugs (not herbal supplements).

Sorry, I didn't say you can't consider Aduhelm to be an herbal supplement, just that every premise and factor in the current discussion would be rendered irrelevant.

So OK, let's agree that Aduhelm is now an herbal supplement. The FDA no longer has the authority to ban it from Walgreens. What's your point? The FDA's decision is about Aduhelm's proven effectiveness as a drug, and it has no bearing on whether Biogen wants to sell it as OTC herbal supplement. Do you believe the FDA is what's preventing Biogen from doing that right now?

The OP was saying how by allowing the accelerated approval, the FDA failed to protect people from a drug that hasn't yet been shown to be effective. My point was that it's not like the FDA protects people from snake oil anyway. Doctors can already get their patients to spend tons of money on unproven treatments. As long as the treatment isn't lying about what the evidence has shown, adults and their doctors are able to make decisions based on available information, and generally society is ok with that. That sentiment conflicts with OP's sentiment. That is why the comparison is relevant to the discussion.

And in your hypothetical example, should insurance companies be required to cover this treatment? In other words, should other insurees be required to pay for it?

It depends on whether or not the insurance company determines it's of value enough to their customers to include it in their insurance package. Insurance companies don't insure all prescription drugs.

That would be considered off-label prescription.

Which is commonly done, and legal, right?

Yes, 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.

The 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.

That's true of some drugs anyway, especially newer ones where the effectiveness isn't as well studied.

>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.

Committing fraud against the most desperate, vulnerable people in the country is universally regarded as unethical.

But 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.

This 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.

except that financial resources are finite . Without certain standards, costs would spiral out of control more than they already have.

I 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.

We can create combinatorially many drugs. There are labs that can screen hundreds of thousands of molecules a day. So approving drugs that aren’t proven effective for a disease might reasonably lead to few or no drugs that are effective because it’s so easy and relatively cheap to stuff a development pipeline with promising drugs if you don’t need to worry about whether they work at the disease stage due to crowding out effective drugs.

I'm so sorry for your struggles and those of your family - Alzheimer's is a terrible disease and I too want to see it treatable as soon as possible, but in this case, if the data is inconclusive, then the drug is not actually a treatment for the disease, that's the point. The purpose of all the trials and tests is to ensure that a) the drug actually does what the scientists in the cutting-edge labs think it does, and b) that it's safe or at least has manageable side-effects.

I have a relative with this disease so I understand the drive to find a cure but it helps no-one to push through a drug that may end up causing more damage.

What could be benefited by not approving it with all the pertinent disclaimers about effectiveness?

And to turn it around, what harm would it cause society if it’s not approved due to inconclusive evidence and helps only some people? (Assuming no hard side effects)

Keep in mind, there are already ineffective treatments that sell hope and don’t help.

The drug has significant side effects, likely with more to be recognized in wider use — especially in combination with other people.

There is a massive cost, which will be paid directly by patients (creating financial stress & conflicting with other care needs) and indirectly by insurance providers who will cut corners and raise costs for everyone.

There is a psychological cost to telling people to take on all of the previous costs for something you know won’t have any benefit. Offering false hope isn’t a kindness.

"What could be benefited by not approving it with all the pertinent disclaimers about effectiveness?"

Let's say it is approved, with all pertinent disclaimers. And that it has no side effects (which seems unlikely).

With little evidence of effectiveness, insurance, public or private, will not pay for it. They have every right, and at least a fiduciary responsibility not to.

But you are desperate, and you are willing to pay $130/day for the drug. What happens if it doesn't work? (As you say, the list of things that don't work is extensive.) Are you going to post on the net, "Our mother's medication didn't work and literally bankrupted us, but it's our fault"?

The biggest harm is going to be people getting side effects with no benefits. I suppose you could argue that Alzheimer's is so bad that who cares about bad side effects, but usually you would not want a drug on the market with no real benefit and a bunch of potential side effects sitting out there.

Caveat: I'm not medically or pharmaceutically qualified

> What could be benefited by not approving it with all the pertinent disclaimers about effectiveness?

It prevents the drug being prescribed (at great cost!) to people who are desperate to try anything.

What would be the benefit of approving such a drug? Who is missing out by not being able to take a drug not known to be effective? I would consider it malpractice to be prescribed something not demonstrated to have a measurable positive effect. The human body is vastly complicated - we shouldn't mess with it without good reason.

> And to turn it around, what harm would it cause society if it’s not approved due to inconclusive evidence and helps only some people? (Assuming no hard side effects)

If it's not approved, then I would argue no harm comes to society. What harm is done if a drug that wasn't available before, still is not? Nothing has changed.

> Keep in mind, there are already ineffective treatments that sell hope and don’t help.

Absolutely, and they are, in my opinion, a work of evil. But the crucial difference is that such treatments (I'm assuming you're referring to quackery such as homeopathy) contain no active ingredient. That's why they aren't regulated. They can't cause medical harm because they don't do anything.

And charging your mother $90,000 for a drug that does nothing at all isn’t a fix.

Mom's on social security she doesn't hasn't paid for any medical procedure in years. Have you heard of Medicare? Medicaid? You don't know what you're talking about at all selectodude.

Sorry, but how does the fact that the government pays for your mother's healthcare make your position more defensible?

> I can walk 5 minutes down the block and buy an eight ball of fentanyl from a guy named TJ but I can't get Alzheimer's treatment made by a team of scientists in a cutting-edge lab because it doesn't meet some government worker's idea of "good enough"?

You're implying that "some government worker" is too incompetent to have the power to regulate experimental drugs. And now you're arguing that it'd be cool for those same government workers to rubber stamp approve and also pay for drugs that don't have the backing of scientific evidence, which is the textbook archetype of "incompetent government worker".

Not that your hypothetical question makes any sense. "TJ" selling fentanyl down the block is illegal. Biogen selling this unapproved drug is illegal. You have the same ability and legal issues to try to buy from them.

This is going to sound harsh, but the fact that other people (government/tax payers) are paying for it makes this even less defensible - wasting your own money on treatments that is likely to not work is one thing, but this risks diverting a shared resource from treatments that _do_ work.

I recently lost my grandfather to vascular dementia, so I understand the feeling of hopelessness, but this is not a solution. I'd _perhaps_ support your right to buy the drug privately, but this would open others up to scams and treatments that have no chance of working (or are in fact harmful). This isn't the same as the war on drugs, where people wanting to buy a particular drug are stopped for (largely) moralistic reasons - this is about ensuring the drug does what the company claims and protecting desperate people from being ripped off.

I hope you can find peace. I’ve been in your situation and I understand the desperate hope for anything at all that has even a chance of working.

Be well.

Thank you <3

Are Medicare or Medicaid covering Aduhelm to treat Alzheimer's? I don't know how the flow goes from FDA approval to certification for use by the government-administered insurance programs.

That would be Biogen's next step, politically speaking: use public pressure ("They're preventing us from getting a drug that might help!") to force Medicare to cover it.

Sorry to hear that about your close family/friends. However, vouching for a rushed approval based on emotions is why such panels exist. That quality assurance is extremely important, especially with respect to drugs. Keep in mind the worst case scenario: the drug does not work, the drug causes adverse side effects, AND it costs money.

> I can walk 5 minutes down the block and buy an eight ball of fentanyl from a guy named TJ

I think TJ might be yanking your chain. "An eight ball" refers explicitly to 1/8 ounce of cocaine.

There would be approximately 35,000 doses of fentanyl in an eighth of the stuff.