If the “Primary Endpoint” in an Alzheimer’s Study is Outcomes, Think Biogen + Spotify

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Taking the example of music’s effect on Alzheimer’s disease patients, John G Singer makes the case for a more holistic approach to healthcare; focusing less on the transformative potential of individual drugs and more on value as a stream of benefits delivered through a living system.

 

Singer/songwriter Glen Campbell, best known for songs like “Rhinestone Cowboy” and “Gentle on My Mind,” went public with his Alzheimer’s diagnosis in 2014 and allowed his journey to be documented in the film “I’ll Be Me.” The film’s director, James Keach, followed Campbell on his farewell tour that year, as he and his family navigated the wildly unpredictable nature of his progressing Alzheimer’s disease using what his family described as “love, laughter and music as their medicine of choice.”

“Continuing to engage with music helped him plateau,” his wife, Kim Campbell, said at the time. “Music really kept him content. We would use it to soothe him when he got agitated.”

When it aired on CNN on the summer of 2015, it did so with only a limited number of commercials – one appearing just before the film started, at one point in the middle of the documentary, and then at the end — marking the first time CNN ever aired a film in that fashion. The three commercials were all sponsored by Eli Lilly, which was (and still is) trying to find a drug to cure or treat Alzheimer’s.

The three ads shown during the documentary included a 30-second spot featuring Eli Lilly CEO John C. Lechleiter talking about why the company was sponsoring the movie; a 30-second spot that pushed viewers to visit a Web page devoted to the film; and a 75-second public service announcement from Ron Peterson, director of the Mayo Clinic’s Alzheimer’s Disease Research Center, discussing new developments in research.

“We want this to be our gift to patients and people suffering from this disease,” said Phyllis Barkman Ferrell, Eli Lilly’s global Alzheimer’s disease team leader, about the company’s sponsorship of the documentary. “We are not asking something of them. We are trying to give something to them.”

Glen Campbell died August 8, 2017.

There is a growing and published body of evidence that music activates regions of the brain spared by Alzheimer’s and alleviates symptoms of the disease. As measured on the same rating scale (CDR-SB), music therapy provides cognitive benefits for people with Alzheimer’s that is on par with Biogen’s experimental drug, aducanumab, which the FDA is set to review for approval on June 7. (If cleared, aducanumab would be the first drug cleared to promote its benefits for slowing cognitive decline.)

While musical therapies are rarely stand-alone treatments, they are increasingly used as adjuncts to other forms of medical treatment as a new form of care innovation to help people cope with stress and mobilize their body’s own capacity to heal. It is used by forward-thinking hospitals and healthcare professionals – customers of the pharmaceutical industry — in targeted treatments for asthma, autism, depression and more, including brain disorders such as Parkinson’s disease, epilepsy and stroke.

“Music takes patients to a familiar home base within themselves,” said Dr. Manjeet Chadha, the director of radiation oncology at Mount Sinai Downtown in Manhattan, in an article on the Healing Power of Music in the New York Times last month. Mount Sinai is a leader in integrating music therapy into its care management workflows, developing new care pathways as part of a broader shift to use ‘novel elements of value’ to improve outcomes and provide better ‘customer experiences’ for patients and their families.

Which begs the question:

If the primary endpoint in an Alzheimer’s study is outcomes – slowing cognitive decline or improving cognition, for example, or reducing agitation — vs. proving out the technical merits of drug (e.g., reduction of amyloid accumulated in the brain), then why not combine ‘music + drug’ as the thing to study and seek approval by the FDA, a new science of synthesis with a greater probability of delivering “outcomes that matter to patients” than either piece in isolation?

Framed within the context of a commercial model innovation, could a Biogen + Spotify combination yield a new ‘system of value’ from which to treat Alzheimer’s, where the theory being tested is not the amyloid hypothesis per se, but cognitive improvement from the interactions on shared marketspace?

To lead the next cycle of evolution in healthcare, we need to shift our creative and analytic focus to the system level, not the constituent parts.

 

Healthcare is a ‘Nested Market’

“Healthcare” in the United States is a ‘nested market’, one massive and ever-expanding complex of interactions and feedback loops in a USD four trillion health economy that is understood, rewarded and regulated as isolated and independently operating spheres.

A modern strategy swaps the ideal of ‘product’ for the ideal of system. It creates space to set standards for exchanging information. It embeds ‘progressive integration’ as an initial condition for policy in the digital age, where the rules are designed to encourage others to improve system performance. Maintenance of the whole matters more than “innovation” of any one specific piece. The role of technology is to reproduce itself as an ‘endless ladder’ in a new economic model.

Which is to say the right way to think about “value” in healthcare (+ life sciences) is continuously, as a flow, a stream of benefits delivered through a living system. It’s not one thing that improves outcomes, it’s many things simultaneously and interactively.

It’s time to recognize, quickly, the foundational fragility of the Western mode of linear thinking – of breaking things apart to study them — and understand the weapons of mass entrenchment keeping the structural stalemate in healthcare alive are more conceptual than they are technical.

There is a commercial withering from communicating in cliché, a vacuum of new words to foresee differently, that threatens to calcify the psychic disintegration of the American way of healthcare beyond anything the thin and threadbare language of “data” can handle as novel vision. The long arguments about “price” and “cost” and effectiveness of a piece in isolation have completely overtaken ‘the production of health’ as conceptual territory for market innovation.

Seeing and thinking in terms of systems is the mother lode to mine for a new imagination, the kind of creative leadership that solves for strategic atrophy. This isn’t a moral argument about “doing the right thing,” but an understanding that radical forces are changing not just the rules of the game, but the game itself.

We need a new system of ideas.

A strategic “transformation” of the industry complex defined and bounded within the context of the “drug market” — drug production, drug regulation, drug manufacturing, drug promotion, drug marketing and sales – begins with a wider frame about what it means to create and compete on outcomes, a high spot from which to see where new storylines of value can flow from a new vantage point.

“Aducanumab is not the drug to launch a new era of Alzheimer’s treatment,” writes Jason Karlawish in a dissenting opinion in STAT. “It hasn’t been properly studied, and so the FDA has incomplete data to form a judgment. The cause of this is a series of decisions that were good for business but bad for science and patient care.”

Which misses the point.

Markets are not only about the production, distribution and consumption of material goods, but also about human interaction in general and the principles by which people make decisions. In the end, the question of markets is really a question of how to live together.

The next health economy is less about thinking in terms of markets in isolation from each other – e.g., the pharmaceutical market developing or launching a new drug for Alzheimer’s, or the hospital market using music therapy for care delivery innovation, or investors trying to pick winners in the $24 billion music streaming market – but more about the way market fragments can be combined into new industry ecosystems. Less about positioning product, more about embedding product within a new context to sustain the production of health.

The question for executive teams in business and government is how to use systems thinking to reframe markets, create unique management capabilities, design preferred relationships with customers, and ultimately open new dimensions for positioning, pricing and performance.

Aducanumab has the potential to be a node in an entirely new system of value. It should be seen as the start, not the end, to a new ecology of engagement between industry and government, between market fragments, and between theory and practice.

/jgs

 

About the author

John G. Singer advises business and government on system change. He is the Executive Director of Blue Spoon Consulting, a global leader in strategy and innovation at a system level. Blue Spoon was the first to apply systems thinking to solve complex market access and integration challenges in the pharmaceutical industry. He does not have a financial relationship with either Biogen or Spotify.


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