Getting the industry on board with digital medicine

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In an exclusive interview, Andrew Thompson, co-founder of Proteus Digital Health, tells us how his company is convincing the industry to embrace digital medicine.

Abilify MyCite made history in November 2017 when it became the first ‘digital medicine’ approved by the FDA.

The product is a combination of Otsuka’s antipsychotic medicine aripiprazole with an Ingestible Event Marker (IEM), or ingestible sensor, developed by Proteus Digital Health. The sensor is embedded in the pill, and when it is ingested the MyCite patch, also developed by Proteus, detects and records the date and time of the ingestion, as well as certain physiological data such as activity level. It then communicates this to the companion app on the patient’s mobile phone.

Abilify MyCite’s approval established Proteus as a company on the leading edge of innovation in the industry, but as is often the case for industry firsts, it has been a long road to get there.

Andrew Thompson, Proteus’ co-founder, president and CEO, says the idea spawned from his own frustrations with how both pharma and tech companies were tackling problems with adherence.

“Part of what you do if you're a healthcare entrepreneur is you listen to the science and try and figure out where the gaps are,” he says. “I was struck by the fact that there was very little consensus about how you most appropriately use medications to get to good patient outcomes, and that it was very hard to tell what drugs patients were using.”

Thompson says that the company is built on a series of deep observations about how digital transformation occurs. “Transformation in digital categories occurs based on high value, high frequency, low friction transactions that take consumers from the physical to the digital space.

“If you ask the question ‘What is one of the most common things that somebody who's sick is supposed to do every day?’, the answer is take their daily pill. If you turn that into a digital event where information about what you swallow and how your body responds is on your mobile phone, and by extension on other people's mobile phones, then they will go and look at which point they are interacting with their healthcare on their mobile. That's not the end, that's the beginning.”

The risk of any innovation like Proteus’ sensor is that if pharma companies and other stakeholders don't get it, they will see it as an additional cost without seeing the benefit – and early on in the ingestible sensor’s development Proteus identified several hurdles they had to overcome to sell the idea.

Thompson explains how the company looked to demonstrate the sensor’s value proposition: Non adherence to medical therapy is not a localised problem. It's one that's true across all demographics, all countries, all cultures, all ages, all people. It's a universal problem.

“If you have a universal problem, then you potentially have a universal solution. What we know about human beings is that they do much better in systems in which there is a measurement, feedback and simple behavioural cues.”

Mental health was one of the first areas Proteus looked to work in because it was one of the areas where their technology could quickly demonstrate a huge impact.

“The solution’s applicability into pharmacotherapy begins with looking for the areas where the need for adherence is most acute,” Thompson explains. “A mental health patient might tell you it's okay if they forget to take their antibiotic, but they’re in real trouble if they forget to take their antipsychotic. Once off the drug regimen that helps stabilise their lives, a mental health patient can begin to think they no longer need their medication. And, of course, if they don't take their medicines they can end up with serious consequences.”

Proteus has also demonstrated efficacy in other areas like hepatitis C – where more than half of patients who are offered treatment with curative drugs are denied access on the basis that there might be an adherence risk – and cardiovascular disease.

“We’ve done a study in the cardiovascular space where we took patients who'd been on a drug for high blood pressure, high blood sugar and high lipids but had failed every one of those endpoints. When we put them onto digital medicines in a randomised study, 98% of the patients reached their blood pressure goal within 90 days, and at the same time they had a massive drop in their lipids and a drop in their blood sugar.”

From there, the second hurdle was to make sure that products like this can be approved in ways that didn’t involve excessive additional cost for pharma companies.

“We negotiated a pathway in the US with the FDA that has now been replicated in Europe and China, in which essentially if you combine an approved drug with our approved devices, then you can combine the label on the drug and the label on the device and you don't need to do any further clinical studies to litigate efficacy or safety.”

The last hurdle was figuring out the business model for the product.

“If there's value and you can release that value through a regulatory pathway that doesn't cost too much money, how are you going to be able to sell that product and justify the investment?” says Thompson. “This is where it becomes really important to understand that what we're doing is transitioning from a product model to a data and service model.

“What we say to customers is, you’re paying for a lot of medicines that don't get taken. Here's our value proposition – pay for medicines that are used and used appropriately, and if they're not used, misused or abused, pay nothing.”

There’s no such thing as healthcare

Digital medicines like Abilify MyCite could be a paradigm shift in many ways, but Thompson says that implementing these kinds of technologies requires more than a change in health systems – it requires a recognition that we don't have a health system at all.

“What we have is a ‘Sick Care’ system,” he explains, “a system that was designed to deal with acute disease and trauma, that in the last century was using the best technologies we had at the time – buildings where you plug into electricity, people with knowledge in their heads and products that are designed to be safe in everybody and work in somebody, because mass standardisation is a great achievement of the industrial era.”

“That works extremely well for the purpose for which it was designed, so well in fact that we now all live a lot longer. Life expectancy has doubled over the last century. But it's really important that we don't begin the conversation about building healthcare by imagining that we can do it by transforming Sick Care. We actually have to build something new.”

“The challenges today are not acute disease and trauma, they are chronic conditions. Just like we built Sick Care with the best technology that was available in the 20th century, we need to build healthcare with the best available in the 21st. The building where you plug in is magnified and made more powerful by a mobile device where you log on, and people with knowledge in their heads are made more productive by software and services with intelligence in the cloud. Products that were designed to be safe in everybody and work in somebody become services that are tailored to you, your genes, your lifestyle and your behaviour. That is digital health. It's not about transforming Sick Care, it's about building healthcare.”

When asked if the industry is being bold enough in digital health, Thompson’s answer is an affirmative ‘No’.

“If you look at the technology industry, they've created a miracle of communication for everyone everywhere. Most people in the world who own a mobile phone make less than $10 a day.”

“This is not an accident. It's a business strategy. Last time I looked, there were five or six tech companies that are going to be worth a trillion dollars – three times as much as any of the world's largest healthcare companies.

“Now let's look at healthcare – we don't have healthcare for everyone everywhere. We have healthcare for the richest people in the richest countries in the world, and that’s also not an accident. It's a business strategy and it's deeply wrong. No, we are not being bold enough because we need to have a very different ethos in our industry. We need to be like tech, we need to be committed to serving everyone everywhere.”

Whatever shape the industry’s transformation will take, it is clear that digital health is not going to stop upending the sector anytime soon, and companies like Proteus will be the ones to watch as health enters a new era.

About the interviewee

Andrew Thompson Proteus Digital HealthAndrew Thompson is co-founder, president and chief executive officer of Proteus Digital Health. He is a World Economic Forum Advisor, and a member of the selection committee for the World Economic Forum Technology Pioneers. He also serves on the California Governor’s Health IT Security Advisory Board and is a member of the Fortune CEO initiative and Wall Street Journal's CEO Advisory Counsel. Thompson has been active as a venture capital investor and entrepreneur in Silicon Valley for 30 years, completing several Fortune 100 M&A transactions and IPOs, and is a named author on 51 issued patents.