Some of you may have seen the news that Aducanumab (from now on known as Aduhelm) was given conditional approval by the FDA for treatment of Alzheimer’s disease. Aduhelm is an antibody that binds to beta-amyloid plaques in the brain reducing their aggregation. It is thought that these plaques are responsible for the development of Alzheimer’s disease. I have written about the original trial in a previous post which you can review here:
Essentially there was minimal to no benefit in cognitive performance in patients treated with Aduhelm in the trial. The conditional approval by the FDA is controversial since the original advisory committee recommended against it. Three members of the FDA advisory committee resigned this week based on this decision.
You may be thinking… “So what’s the big deal? There is no real treatment for Alzheimer’s disease. It may help some patients. Why not use it?” This line of logic is a common mistake.
My prediction is that Aduhelm will significantly increase the burden of Alzheimer’s disease in the U.S. and other developed countries. Its presence in the market place will worsen nearly every metric we use to monitor this disease in patients as well as our society.
Allow me to explain.
First, from the book of Revelations 3:15; “Because you are luk warm, neither cold or hot, so I spew you from my mouth.” Aduhelm in a nutshell.
Next, a baseball analogy to provide some perspective. This drug is not a homerun. For most patients it’s an out. For some it will be an error on a bunt back to the pitcher. Biogen (the company that developed Aduhelm) ran two simultaneous trials during the approval process. One trial showed no benefit. The other showed a small benefit that was barely statistically significant. The outcome was a few points improvement on a cognitive impairment scale. Nothing that would substantially change a patient’s life. All that was seen was a slight deceleration in the worsening of the disease. In the end, the patients in the experimental and control groups were in identical spots. If anything, Aduhelm extended that game from 9 innings to 11 innings and the players had to play through a thunderstorm of side effects. It merely stretched out the disease a little longer for those suffering from it, and it did this painfully at that. Anyone want to take that deal?
When we track metrics for Alzheimer’s disease, we are considering functional independence, incidence (number of people with the disease), duration of illness, resources required, patient burden, caregiver burden, and overall quality of life. Aduhelm did not show to improve functional independence. The patients did not get better. They continued to get worse at nearly the same pace as the control group. The drug will likely increase duration of illness (i.e. time to death), since they are living longer the incidence will increase, therefore the resources required will increase. Caregiver burden will increase because you will have to take care of someone whom is cognitively impaired for a longer period of time. Patient burden will increase in the form of cost for the drug and unwelcome side effects. Everyone’s quality of life will suffer as the disease drags on longer and longer.
What do you get for all your efforts? Maybe your loved one remembers they need to feed their cat for a few more months than they otherwise would have. I’m being a bit facetious here, but that’s basically the juice you’ll get from this squeeze.
The medicine is estimated to cost roughly $50,000 per year. Who will pay for this? YOU WILL. Some of the cost will come from the patient since most Medicare advantage plans do not plan on paying for the entire cost. So, part of it will come from the patient’s estate. The remainder will be paid by the commercial insured. Most Medicare advantage plans come from the major insurance providers. These are United Health, Cigna, Aetna, Humana, Anthem. If you are commercially insured by them, or happen to be on a Medicare advantage plan from one of them but do not suffer from the disease, the cost will be passed on to you in the form of higher premiums. This is part of the reason why premiums continue to rise in this country. It is a multitude of very expensive, marginally effective medications that continue to be released into the market place. The field of oncology has dozens of these drugs. They extend your life for a month at great toxicity and expense. Aduhelm is an oncology drug on steroids. The patient is going to live for about 5-8 years on the medication. The medication doesn’t change the end result, or the journey. The price tag for hope is only $250,000.
The cost of the drug doesn’t even begin to factor in the collateralized cost for the Alzheimer’s patient. Currently the cost of Alzheimer’s care in the united states is at $305 billion. That is expected to double over the next 10 years. That is without the estimated $10 billion in annual costs from this drug alone. If you’re caring for someone with Alzheimer’s you’re looking at the following: Adult daycare $74/day, In-home care $25/hour, assisted living facility (average) $51,600 per year, private room nursing home (average) $105,000 per year. Who pays for all of this? The patient’s estate or their children. This doesn’t even factor in the time expense, emotional expense, and general fatigue of being a caregiver.
Biogen is not an evil company. The FDA is not evil either. They just don’t understand. They assume the market will figure this out. They assume consumers understand the big picture. They are hoping they can help but their solution just isn’t good enough and they don’t account for unseen endpoints. The true patient experience. Everything that is involved with a highly expensive, marginally effective drug. Biogen invested a great deal of resources into the development of this drug. They probably believe it is going to help people. They also know that if it is unsuccessful, they will suffer significant financial and reputational consequences. So, they will fight to get it to market. Honestly, the optics place them in the hero’s role. But the drug is an abject failure, and likely a black hole of misery for its users.
If we really want to help Alzheimer’s patients, we could convince managers to look the other way when a worker has to leave work early because their mother fell and is in the emergency room. Or convince insurance companies to allow customers to count their deductibles towards dependent care within their family. Or convince congress to mandate all large corporations to offer an HSA that can be used to care for elderly dependents. That way pretax dollars can go towards dependent care. My point is, if you didn’t cure it, or reverse it, forget it. It’s not worth it. The drug will only make things worse. People need resources. They need cash. They need room and board. This is what eases the blow. That should be the focus.
I’m sure you may think this is an awful way to view a disease. And it is. But the disease is awful. It’s awful for everyone involved except the patient living with it. They are helpless and unaware. If you’ve ever cared for someone taking care of Alzheimer’s you know it is not a speed-bump. It’s Mt. Everest.
The first couple of years are ok. Your loved one is forgetful; they say odd things. They forget to turn the stove off. A few bills get missed. No big deal. Then it gets worse. They forget to prepare meals. They are up wandering at night. They leave the house unlocked. They forget to bathe themselves. They develop ulcers on their skin, urinary tract infections, and are falling frequently. It’s not safe for them to be left alone. After those years it gets really bad. They rely on their family for everything. They are in and out of the hospital with one catastrophe after another. They usually perish in an ICU or hospital ward, alone, cold, and scared.
Can you imagine that process taking longer than it already does? Would you consider this quality living? This is the utter failure of our system. We throw all of our resources at the disease, and not the patient, and what the patient loves. I don’t want anyone to die. But it’s a necessary part of life. It’s the abyss we all must courageously face. Aduhelm just pushes this process further down the road at a very high cost personally and financially.
I hope I’m wrong.
I leave you with a quote I heard the other day. A friend of mine was telling me a story about someone whom recently passed away. He was 100 years old. Before he died, he asked him, “What did you do to make it to 100?” The old man replied, “I don’t know, but if you get a chance to die at 85, take it!” We have a lot to learn in our culture about life, and death, and aging. As a doctor I have learned there are worser faits than death. There comes a time in everyone’s life when you have to let go, for yourself, or the one’s you love, because they are living in Hell.