4 Reasons Why The New Alzheimer’s Treatment Is A Cruel Scam

Just a few months in the past, the FDA authorised a brand new drug, aducamumab, to deal with Alzheimer’s illness. This was the primary time in 20 years that the FDA authorised a drug for Alzheimer’s, and whereas which will sound hopeful, many specialists have already pointed out that it was a colossal mistake, and a looming tragedy for Alzheimer’s sufferers. Listed below are 4 the explanation why the approval of aducamumab (additionally referred to as Aduhelm) is such a catastrophe.

1. The brand new drug simply doesn’t work. The most important drawback is that Aduhelm doesn’t decelerate or reverse the progress of Alzheimer’s. Greater than a 12 months in the past, I wrote concerning the failure of two trials of aducamumab. The 2 trials, designed to be similar to at least one one other, have been halted in March 2019 by the drugmaker, Biogen, because of a “futility evaluation” that confirmed it simply wasn’t working.

In different phrases, there was no level in persevering with the trials. So Biogen halted them.

However then Biogen tried to rescue the drug. In what can solely be described as torturing the info to attempt to discover a consequence that they actually, actually needed, they went again and checked out a subset of sufferers in one of many two trials, referred to as EMERGE, and claimed that the higher-dose sufferers truly did get a profit.

However the sufferers didn’t profit. All that Biogen may argue was that some sufferers had decrease ranges of amyloid plaques of their brains. An impartial group of scientists additionally seemed once more at Biogen’s information, and published a report saying that their evaluation nonetheless didn’t help any profit for sufferers.

It’s true that plaques do certainly accumulate within the brains of Alzheimer’s sufferers, and aducamumab does appear to scale back plaques. Nonetheless, regardless of 30 years of analysis, nobody has been capable of present that decreasing these plaques has any impact on the progress of the illness.

Extra to the purpose, the 2 trials run by Biogen, which measured medical indicators of illness, discovered that aducamumab didn’t have an effect on the affected person’s diseases. It didn’t decelerate or reverse the inevitable course of Alzheimer’s illness.

The FDA’s personal exterior panel of specialists evaluated the proof and strongly rejected aducamumab. (10 of 11 voted to reject it, and one panelist was unsure.) The panel discovered that not solely was there no medical profit, there was additionally a big threat of hurt, together with harmful swelling within the mind. About one-third of patients experienced these risks, and 10% of patients had to stop treatment because of adverse side effects.

And but in July of 2021, in a virtually unprecedented motion, the FDA authorised the brand new drug. Three of the committee members resigned in protest.

One way or the other, Biogen satisfied the FDA to approve aducamumab primarily based on the drug’s impact on a surrogate endpoint: the extent of amyloid plaque within the mind. One may argue that that is much like approving statins primarily based on their impact on levels of cholesterol: by decreasing ldl cholesterol, we will scale back the chance of coronary heart illness. The analogy is perhaps apt, however there’s an enormous distinction: we’ve information displaying that reducing ldl cholesterol does certainly scale back the chance of coronary heart illness. In distinction, regardless of a long time of examine, we nonetheless don’t have any information displaying that decreasing the degrees of amyloid plaques slows down or reverses Alzheimer’s.

2. A failed speculation. This results in the second purpose why the FDA’s motion is such a catastrophe. For 30 years now, the Alzheimer’s community has pursued the “amyloid hypothesis,” which asserts that the buildup of amyloid plaques within the mind is the first explanation for Alzheimer’s. This was thought-about an enormous breakthrough when John Hardy first proposed it back in 1991, and a whole lot (maybe hundreds) of papers have been printed since that point, exploring this speculation.

Over 100 medication have been developed and examined for his or her capability to scale back plaques, and a few of them (like aducamumab) do certainly scale back plaque ranges. Sadly, none of them slowed down the course of the illness, so that they by no means obtained FDA approval.

After 30 years of effort, it’s clearly time to acknowledge that the amyloid speculation is a failure. And but the Alzheimer’s analysis group continues to cling to it, regardless of all of the proof that concentrating on plaques merely doesn’t work to deal with the illness.

The FDA’s approval, over the objection of its personal specialists and an enormous outcry from the biomedical analysis group, will solely breathe new life into this failed speculation. Much more unlucky is that, by approving a remedy primarily based on a surrogate endpoint, the FDA is now encouraging drugmakers to maintain specializing in plaques, which is able to starve any efforts to search out different causes–and different potential remedies–for this devastating illness.

This leads me to the third purpose why the FDA’s approval of aducamumab is a catastrophe.

3. Greed wins. Why did Biogen work so exhausting to search out some shred of proof that they might use to persuade the FDA to approve their new drug? The reply will be discovered within the value that Biogen set for the drug: $56,000 per 12 months. As the editors of JAMA Internal Medicine have pointed out, if even one-sixth of Alzheimer’s sufferers within the U.S. alone have been to take this drug, the annual value can be $57 billion, which is much larger than the price of all Medicare half B medication mixed in 2018.

In different phrases, aducamumab’s prices may bankrupt Medicare. Or to place it one other means, Biogen doesn’t appear to care if Medicare goes bankrupt, so long as they’ll seize some large income.

What remains to be mysterious is why the FDA determined to overrule its personal advisors. The FDA’s protection appears to be that they are going to require Biogen to proceed amassing information “to verify the drug’s clinical benefit.” However they’re giving Biogen 8 years to gather this information. That’s 8 years throughout which Biogen will reap large income, Medicare may collapse underneath the pressure, and Alzheimer’s sufferers will proceed to undergo.

In October, the FDA announced an investigation of its own approval process for Aduhelm. This appears somewhat weird: if the FDA suspects there was “improper contact” between Biogen and its personal inside employees, then it ought to merely withdraw approval for the drug till the investigation is full.

4. This complete affair is taking merciless benefit of a weak, determined group of sufferers. Lastly, maybe the worst facet of this complete fiasco is how merciless it’s to Alzheimer’s sufferers. As Dr. Jason Karlawish explained in JAMA Neurology, despite the fact that he disagrees with the FDA’s resolution to approve this drug:

“I need to protect and defend every sufferers’ autonomy. A method I do that is by being instructor to sufferers and their caregivers to allow them to make selections about the way to stay nicely with this illness. I can’t deny them the alternatives the well being care system provides them. Aducanumab is now a selection.”

Karlawish goes on to write down that he’ll clarify to sufferers that the advantages are unsure, and the dangers of mind swelling and different unhealthy negative effects are very actual. But when the sufferers select to attempt it, he’ll reluctantly prescribe Aduhelm.

We don’t have any efficient remedy for Alzheimer’s, and it’s a devastating sickness. Sufferers and their households are more likely to be determined, and the mere truth of FDA approval will give them hope. I’ve little doubt that many will need to attempt Aduhelm, regardless of the dangers. Giving them false hope is just merciless.

And don’t neglect that Biogen halted its own trials of Aduhelm because of “futility.”

The FDA made an enormous mistake in overruling its knowledgeable panel and approving an Alzheimer’s drug that simply doesn’t appear to work, that’s outrageously expensive, and that may trigger critical hurt to some sufferers. Let’s hope that this resolution will be reversed. The world wants a secure and efficient remedy for Alzheimer’s, and for now, we merely don’t have one.