“Talk to your doctor” works when the drug is cheap.
But if Medicare decides you’re on the hook for the price, then talking to your doctor may well end up reassuring you that it’s not worth it because it might not even work.
Do not underestimate the way that loss aversion biases people against paying a lot for something of uncertain benefit. Would you rather bet $10 on a slightly slower horse or $10,000 on a slightly faster horse?
Normally I’d agree… but man, this country is so upside-down I don’t think anythings a given anymore. I mean… people bet on companies with zero value all the time now (Gamestop, crypto, MLM).
I can practically guarantee that Medicare ain’t paying $56,000 / yr for this drug.
They definitely don’t pay $5K for an MRI. A few hundred dollars at most. Next year, probably slightly less. Because that’s just how Medicare rolls.
$5k stated for the quarterly MRI’s needed, not just one. They cost anywhere from $1,000-$4,000 depending on the hospital system. My hour + MRI’s cost ~$2,500
We should continue to pursue the causes of dementia and trials of medications that might help. Approving a medication that has not been shown to impact the disease is snake oil. Medicine is evidence based these days, so you gotta provide the evidence in order to get approval, not get approve in order to get the evidence - that’s what clinical trials are for.
Yes, hospitals charge over $1K for an MRI. But Medicare only pays a few hundred dollars, the patient pays even less, and the hospital has to eat the balance.
On a slightly different tangent, it’s unreal we have such a well documented, long-term disease that’s been around forever… and we still have these functional lapses in how this disease initially triggers works. I can’t think of another non-brain based disease that’s been this difficult to unequivocally nail down in this manner.
Well, I guess if you’re satisfied with where drug companies direct their efforts, then we should continue the status quo.
I am not satisfied with where drug companies direct their efforts, because they do so to make money, not to provide the most important care for patients, same as insurance companies. That is a different topic than whether the FDA should approve medications that have not been shown to be effective in disease control or prevention.
It’s a different topic, but related. Drug companies will focus their efforts on drugs most likely to win approval. Drug companies are rarely willing to pay for decade-long studies. And everything we know about Alzheimers suggests that after a short term study of an investigational agent, we are far more likely to see a change in cholesterol/blood pressure/blood glucose than in memory. So unless one of those things changes, the status quo is inevitable.
If private companies don’t see a profit potential in developing medications for diseases that will take years for trials, they won’t do those trials. That’s certainly true. So for diseases with mechanisms that appear to take years, we need trials that go on for years, like the kind that are done by places like Mayo and medical schools, typically with government grants. Some diseases are more amenable to short trials than others - can’t change that.
The function of the FDA is to verify that drugs are safe and effective prior to being used in the general population. It is not responsible for the FDA to approve medications that have not been shown to help with disease control or prevention. That is why people are resigning from the board - this isn’t how the FDA is designed to work. Do the trials, follow the results, and then approve the drug, not the other way around.
I understand the frustration that there isn’t a drug that helps with dementia yet, but approving snake oil doesn’t help, and undermines confidence in the approval system.
You are describing a phase 3 trial, and government grants are not primarily used for those. Grants are intended for cheaper studies that produce more general knowledge. Validating an investigational drug for a new indication is primarily paid for by drug companies themselves. Some grants are used for long-term retrospective studies (i.e. how did this drug actually perform in the population), but obviously that won’t work for an unapproved drug.
Now, perhaps you are suggesting that government should fund more prospective long term studies, ie use federal money to buy investigational agents and then allow scientists to look at the possible long term benefits. But if you think about it, that’s more or less what is about to happen with this drug.
I’m all done with this talk, as you are not addressing the purpose of the FDA and how this action violates their directive. I think there are plenty of ways to improive how drugs are tested and approved in this country. Approving a drug for use in the general population when trials do not show that it works is irresponsible and the opposite of what the FDA is supposed to be doing.
I won’t be prescribing this one, but I’ll likely have to spend a fair bit of time telling patients why. And they will say ’ the FDA approved it, why won’t you prescribe it?’. Sigh.
They have had a mechanism in place for 30 years to approve drugs solely on the basis of surrogate endpoints.
Perhaps their directive is no longer what you think it is. It changed after popular outrage over their unresponsiveness in the HIV era.
There is plenty of evidence that it works to reduce amyloid.
If you don’t think that’s enough, fine. But there is a long list of drugs that have been approved merely on the basis of affecting lab assays. They all went through the same mechanism as this drug.
One of those drugs was Gleevec. When the FDA approved it for leukemia in 2006, there was no evidence that it improved survival. There was plenty of evidence that it worked to reduce BCR-ABL, a surrogate endpoint like amyloid. And there were no other effective drugs for this type of leukemia. Would you have recommended it?
Yes, surrogate endpoints make sense when there is a causal relation, but there is no apparent causal relation between amyloid and dementia. This is the point that I and others are making here that you are not addressing. But I said I was done, and I will not respond to any more of this apparently deliberate obtuseness.
First of all, causes precede effects. Like this:
Second of all, there is plenty of evidence that amyloid causes Alzheimer’s, here is a recent review:
Among other things, the biggest genetic risk factor for Alzheimer’s is a protein that controls amyloid deposition. Of course there is room for debate, but you are mistaken to suggest that there is no reasonable basis for a causal relationship.
Naturally, incontrovertible proof that amyloid causes Alzheimers depends on showing that clearing amyloid prevents Alzheimer’s. But by the same token, in 2006 there was no incontrovertible proof that clearing BCR-ABL would cure leukemia. Then and now, the FDA does not require the same level of proof that you demand.
FWIW, while it’s clearly a frustrating conversation for y’all, I just want to say “thanks” for having it. I’m learning a lot. No where close to enough to have an informed independent opinion, of course, but the overall thought process and differing perspectives are fascinating.
I seen a armadillo oncet
Are you serious? If so, that’s even more disheartening with what’s going on.
Real live armadillo