“A Disease in America Doesn’t Really Fully Exist Until It Has a Business Model”

This week: a conversation with Dr. Aaron Kesselheim and Dr. Jason Karlawish about Alzheimer’s disease and the FDA’s approval of aducanumab. Listen today at 2 pm or anytime at our website.

After the historic success of pandemic vaccines that met FDA standards of “safe and effective,” the FDA recently approved a drug that experts say hasn’t been proven safe or effective. That drug is Biogen’s aducanumab, intended to treat Alzheimer’s disease. After its approval, Dr. Aaron Kesselheim of Harvard resigned from his FDA advisory committee post in protest. Dr. Kesselheim joins us for this week’s show and says:

I think we should be worried because, you know, I think that this decision was a problematic decision on a lot of different levels. First of all, as you pointed out, the clinical trials that we require companies to do to show that their drug works did not show any convincing evidence that this drug worked. At the best, it provided a signal that there might be some effectiveness. But that should be the basis of further testing. And, you know, there is a lot of conflicting evidence that suggests that the drug just doesn’t work.

Dr. Aaron Kesselheim.

In spite of all this, Kesselheim tells us, aducanumab is already part of American healthcare. The FDA’s decision, Kesselheim points out, stands:

Not only will it stand, but my understanding is that Biogen has already started shipping the product out and patients have started treatment with it. So I think that the decision is going to stand. But I do think that this does put a lot of pressure on the healthcare system and, you know, whether Medicare is going to pay for it, and on physicians and patients in deciding whether or not to use this product.

I think another major issue that this case brings up is it points to the fact that in the United States, we basically allow companies to set whatever price they want for their new drugs. And as a result of that, the company that makes this drug can set a sky-high price and it can be assured that our government payers are going to cover and pay for the drug at that price.

Now, it’s possible that our government payers may take a stand and try to put limitations on patients who qualify for this drug or some other limitations on it. Those kinds of stands would be very rare. It’s very rare that the government does that. And even so, as you mentioned, there are so many people with Alzheimer’s disease that even if this drug is used in a minority of those patients, it will still cause important potential financial strains on the healthcare system.

Dr. Jason Karlawish, author of The Problem of Alzheimer’s, describes how Alzheimer’s itself has already frustrated patients, their families, and our healthcare system for years:

What’s happened with aducanumab reveals a larger problem that haunts Alzheimer’s disease and has haunted Alzheimer’s since 1980s or so, and that is that a disease in America doesn’t really fully exist until it has a business model. That’s been a problem with this disease, namely the ability for the millions of people with it, as well as their family members to get the diagnosis and care they need, has been a series of just constant frustrations.

Jason Karlawish.

Watch: Mirror

Alzheimer’s effects on memory, as Dr. Karlawish explains this week, have familial and social ramifications. Memory in general, we’re reminded, affects more than just the individual rememberer. Andrei Tarkovsky’s Mirror, a film about memory, gets at this interpersonal nature of recollection.

Mirror links together Tarkovsky, his father, his mother, and literature, all in a chain of cinematic memory. What might otherwise be a jumble of impressions becomes a constellation of feelings and thoughts that shape time. From the BFI:

For perhaps his most daring experimentation with film structure, Andrei Tarkovsky intersperses scenes from three eras — a childhood in the countryside, the Great War, and post-war maturity — to create a prismatic reflection of his own life and those of his parents.

Abandoning linear narrative in favour of dramatising discontinuous shards of memory (particularly relating to his mother Maria, played by Margarita Terekhova), Tarkovsky pioneered a poetic and richly allusive form. Wartime newsreel footage, self-consciously painterly compositions, indelible imagery (a field whipped suddenly by wind, a gas lantern flickering out), and the director’s mesmeric camera movements combine to create a work of cumulative, rhythmic effect. The soundtrack features music by Bach, and Tarkovsky’s father Arseny Tarkovsky reading from his own poetry.

Read/Watch: Still Alice

Julianne Moore in Still Alice.

Still Alice is both a book and a film about a professor diagnosed with early-onset Alzheimer’s. From The Conversation:

The film, especially, stresses that societal attitude to those living with dementia needs adjustment. Alice states soon after her symptoms become pronounced: “I wish I had cancer … then I wouldn’t feel so ashamed.” Later the film’s call-to-arms is a speech given by Alice to a gathering of the Alzheimer’s Association where she rails against perceptions of being “incapable, ridiculous, comic”.

The call for more dementia-friendly communities has been a significant focus of recent advocacy campaigns. Though research into clinical interventions continues, breakthroughs remain elusive while rates of prevalence are set to grow rapidly across the globe.

This week’s ephemeral library

On the 50th anniversary of Joni Mitchell’s Blue album. Alex Ross on the birth of gay rights in Los Angeles. Brian Dillon on Antonio Muñoz Molina.

An American conversation with global attitude, on the arts, humanities, and global affairs, hosted by Christopher Lydon. chris@radioopensource.org