I am deeply concerned about the way the US Food and Drug Administration (FDA) has approved Biogen’s aducanumab for use in people with Alzheimer’s disease.
As a neurologist, and currently a PhD student in Clinical Neurosciences working on memory disorders, I see people with various forms of cognitive impairment. Indeed, many of them have Alzheimer’s disease and are desperate for something, anything, to treat the condition.
Sometimes it’s difficult to appreciate how devastating it is to slowly lose one’s memory. Unlike losing an arm to gangrene, for example, it is not a painful condition. And yet, you can lose an arm, or a leg, and still be essentially the same person. But take away someone’s memories, and what’s left is but a shadow of their former self. Ask any person caring for a loved one who has dementia: what wouldn’t you give to restore their memories so that you can have just one more day with that person?
The approval of aducanumab is highly unusual because there’s no convincing evidence that it actually works. Sure, Biogen are claiming that in a subset of patients, on a certain dose of the medication, you can see some statistically significant (God I hate that phrase!) difference. But let’s be clear here: this sort of selective interpretation of the evidence is rightly frowned upon by the scientific community. To make matters worse, aducanumab has potentially dangerous side effects: 40% of patients developed brain swelling after receiving it.
Despite all that, I’m still willing to accept the justification for approving it under rigorous conditions. After all, Alzheimer’s disease is a devastating condition, and we are all desperate for a treatment.
What I cannot understand, and cannot accept, is how the FDA can simply let Biogen set the price at $56,000 for a year’s supply of aducanumab.
This is cruelty.
This is greed, taken to a whole new level.
How can it not be, when, according to this article in Nature, “if 5% of the United States’ 6 million Alzheimer’s patients receive the treatment, the drug’s revenue would reach nearly $17 billion per year”?
Seriously, who needs 5G-microchip-anti-vaccine controversies when real life is even worse? How do we justify letting a company charge the equivalent of people’s life savings for an unproven treatment just by dangling the chance of a cure?
So please spare me all this nonsense about caring for people with Alzheimer’s disease. If Biogen really cared about patients, they wouldn’t be charging $56,000 for an unproven treatment. I hope the National Institute for Health and Care Excellence (NICE) here in the UK will do the right thing by not approving its use on such flimsy evidence.