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Exponential Medicine

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By MATTHEW HOLT

After only maybe 5 years when I’ve been away running a conflicting conference in some other part of the world I finally get to go to Exponential Medicine the next 4 days. I met Daniel Kraft way back before he was famous, and his conference grew from being a week long academic session in an airline hangar in Mountain View to being a mega 4 day bash at the Hotel Del Coronado in San Diego (partly aided by TEDMED abandoning the venue and heading off in its own strange direction post billionaire buyout–well done Mark Hodash despite the lawsuit and yes I am jealous!).

Anyway, it’s going to be lots of fun. There’s plenty of people from my Health 2.0 world presenting. Lonnie Rae Kurlander, ePatient Dave, heck even John Halamka has been tempted off the farm — although I suspect Dave will have him in a headlock about access to his BIDMC data pretty quick).

Then there’s the surgeons and the weirdos. I leave Shafi Ahmed & Stefano Bini to decide which category they’re in, although whatever John Brownstein says I do owe him a nice bottle of scotch. Anyway, check out the program and if you haven’t bought yourself a ticket or bribed your way in, don’t worry it’s all being live streamed and Jessica DaMassa from WTF Health will as ever be interviewing anyone who doesn’t get out of the way quick enough.

So if you’re there I’ll be milling around not doing much, so say hi. And otherwise follow along here and @boltyboy

Health in 2 Point 00 Episode 56

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On Episode 56 of Health in 2 Point 00, Jess and I report from Livongo’s new office in San Francisco. In this episode, Jess asks me about Carrot Health’s $25 million raise for their digital smoking cessation program and 98point6’s $50 million raise for their on-demand primary care app. We also have our special guest star Dr. Jennifer Schneider here to tell us about how Livongo is working to Silence Noisy Healthcare with Applied Health Signals- Matthew Holt

 

The Rule of Thirds

By Marya Zilberberg, MD

When I was a medical student, I did a lot of rotations at the Boston VA in JP. I loved my patients there — they were patient and kind and stoic. One of the best rotations I did was Hematology, where Lou Fiore was my preceptor. Lou was not only an excellent teacher, but also a terrific doctor and a good human being all around. He used to start our days together by saying, “I’m gonna teach you one thing today.” And teach us he did, at least one thing per day. Now I teach. And on occasion I have used the Lou Fiore “I’m gonna teach you one thing today” promise. Well, today is one of those days: I’m gonna teach you one thing.

And here is that thing. I am sure I am not the first one to notice this, but I still think of it as the “Zilberberg rule of thirds.” The gist of it is that, for clinical research purposes, one can think of patient populations crudely in thirds: there is one third who are too sick to benefit from any of our interventions, there is one third who are too healthy, so that no matter how we try to tweak, their outcomes will not change, and the middle third, which comprises the “sweet spot” for intervention. So it is a fool’s errand to pursue proof of concept studies in either of the bracketing thirds, since it is only the middle third that is likely to show a signal.

Pharmaceutical manufacturers do not always appreciate this trichotomy. Look at Vioxx, for example: when used in patients who were essentially healthy, an unacceptable safety signal arose that drove the drug off the market. Same for SSRIs, where the ill-conceived enthusiasm for treating marginal depression cases seems to be debunking the entire serotonin hypothesis. The flip side is sepsis research: septic shock patients are so far gone that it is difficult for any single therapy to alter their outcomes. Just look at the Xigris story, as well as myriad other therapies that tried and failed. This is the rule of thirds at its most pronounced.

In HEOR the rule of thirds holds as well. To prove cost effectiveness the following questions need to be asked:

1. Is the disease in question prevalent?

2. Is the economic impact of the disease known and substantial?

3. Does the diagnostic/therapy in question alter the course of the disease in such a way as to be significant?

If the answer to any of the questions above is “no,” you really need to think carefully about the value proposition.

Some of you will bring up the inter-individual differences, the heterogeneous treatment effect, etc. And yes, these are supremely important. However, though the framework I propose here is simplistic, we have to start somewhere. To be sure, there is a more nuanced approach to this beast, but generally, one will not go wrong by asking these questions before committing huge resources to a project, particularly if the answer to question 2 or 3 is a resounding “no.” So, even in health economics it behooves one to know the Zilberberg rule of thirds: choose the right population where the diagnostic/therapeutic advance and its costs can be justified by a substantial gain in the outcomes.

And that is your one thing for today.

Marya Zilberberg, MD, MPH, is a physician health services researcher with a specific interest in healthcare-associated complications and a broad interest in the state of our healthcare system. She is the Founder and President of EviMed Research Group, LLC, a consultancy specializing in epidemiology, health services and outcomes research. She is also a professor of Epidemiology at the University of Massachusetts, Amherst. Dr. Zilberberg blogs at Healthcare, etc.

The Road Not Taken: The Unrecognized Harm of Excessive Regulation

By David Shaywitz

The difficulty of creating new and better medicines has been the subject of extensive – at times excessive – soul searching, a process that’s intensified as high-profile patents expire, along with their associated revenue streams, traditionally relied upon to support future R&D.  As a result, both biopharma companies and patients awaiting new treatments find themselves struggling for viable solutions.

Predictably, industry (where I obviously reside) attributes excessive regulation, regulators say “don’t blame us,” and considered reporters and observers typically try to split the difference – maybe everyone is a little bit at fault.

The problem with this resolution is that it’s a cop-out; while there is clearly a measure of shared responsibility, it’s willful blindness not to recognize the extent to which a deliberate and very conscious regulatory policy is putting a damper on what has traditionally been the world’s most vibrant drug development ecosystem.

It’s not that other factors (such as the complexity of science) aren’t important – in fact, it’s precisely because developing new drugs is challenging, so inherently difficult, that’s it’s crucial to do everything within our control to work together and create an environment, an ecosystem, that stimulates and enables meaningful innovation.

The most significant – and potentially, most correctable (which is why it’s especially frustrating – it’s explicitly of our own making) problem – is that regulators, as others have astutely observed, seem to have misapplied the “precautionary principle,” colloquially understood as “first, do no harm.”  The problem isn’t so much the sentiment as the way it’s reduced to practice.

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Racing to Nowhere

By Merrill Goozner

I had dinner over the weekend with a close friend who is a breast cancer survivor (her word) and a former avid participant in the annual marathons sponsored by the Susan B. Komen Foundation. Her status as a former activist was new. “Is this what we were racing for?” she said. She is skeptical by nature, and the brouhaha over Komen’s back-and-forth over funding Planned Parenthood last week didn’t make her angry. It merely flipped the switch that changes skepticism into cynicism. To paraphrase the old Phil Ochs song, she ain’t a marchin’ anymore.

I try to avoid bringing my knowledge about medical issues into private discussions (I’m not a doctor, and I take that caveat seriously. But as readers of this blog know, I’ve written extensively about recent controversies in breast cancer research, including the dust-ups over the U.S. Preventive Services Task Force recommendation that women under 50 can eschew mammography, and the Food and Drug Administration’s decision to withdraw Avastin’s approval for breast cancer). Yet my friend asked me pointedly about what I thought about Komen and why they did what they did. She knew nothing about the organization she had been supporting for many years, and now wanted answers.

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Fraudulent Cancer Research: An Exception or the Tip of the Iceberg

By Jason Shafrin

Yesterday, 60 Minutes reported on Dr. Anil Potti, researcher at Duke University.  Dr. Potti supposedly offered cancer patients improved cancer treatments.  These recommendations, however, were based on falsified data.

“Five years ago, Duke University announced it had found the holy grail of cancer research. They’d discovered how to match a patient’s tumor to the best chemotherapy drug. It was a breakthrough because every person’s DNA is unique, so every tumor is different. A drug that kills a tumor in one person, for example, might not work in another. The research was published in the most prestigious medical journals. And more than a hundred desperately ill people invested their last hopes in Duke’s innovation.

In 2010, we learned that the new method was a failure. But what isn’t widely known, until tonight, is that the discovery wasn’t just a failure, it may end up being one of the biggest medical research frauds ever – one that deceived dying patients, the best medical journals and a great university.”

When the National Cancer Institute found they could not replicate Potti’s results, Duke suspended the enrollment of patients in the Potti study and asked outside review committee to analyze Dr. Potti’s discovery. After three months, however, the review committee concluded that Dr. Potti was right.

Why did no one find out earlier.  Were researchers blinded by money?

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Tremors

By Dr. Wes

I am seeing the world of medicine change before my eyes, and I wonder where we’re going.

Never before has there been more information at our disposal, yet more confusion. Like molecules being heated, the Brownian motion happening in medicine seems completely ineffectual for those of us on the front lines of care, geared more toward expensive facades than substance.

For the most part, doctors keep their heads down. Most of us are busy caring for patients, pushing to get home at least once each week before dinner. Most are humble servants to their patients, working tirelessly for their benefit. Sure, there are a few doctors participating in policy or medical associations, but it’s clear to the rank and file that their leadership has already cashed out from patient care and are no longer participants in what medicine has become today. Worse: they’re too few in number and too underfunded and occassionally displayed as hood ornaments to validate a central policy decision.

Then there’s call. No one likes call, but it must be covered. Doctors understand that medicine is 24/7/365 affair. But there’s more people now, more places, and yes, more call. The burden falls on the doctors, so the tremors resonate louder. No large ones, mind you. But they’re happening. Doctors are pleasantly, professionally, reaching critical mass.

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Biopharma + Digital Health?

By David Shaywitz

Biopharma – especially big pharma – gets all sorts of grief for being large, stodgy, and unable to innovate (or evolve);this Corey Goodman interview represents the perspective well.

Before writing off these companies entirely, however (an ignorant reaction in any case), it’s important to consider how much experience they have in doing two very difficult, very important things: (a) documenting the medical value of their products through a rigorous series of clinical studies conducted in a highly regulated environment; and (b) navigating their way through a complex maze of stakeholders in order to successfully market their products.

Much of the difficulties facing the industry these days stem not from their lack of regulatory experience or marketing skill, but rather from the intrinsic value proposition of the products they offer; simply put, making an impactful new drug is extremely hard and quite expensive, as Matt Herper’s recent piece makes clear.

My sense is that the view from the digital health/start-up side is in many ways the mirror-image of this: the space seems to be brimming with promising nascent ideas; yet, as I’ve discussed before, the measurable health impact of these technologies is usually unclear (at best).

Some emerging digital health companies don’t worry about this – they are deliberately seeking to circumvent the regulatory process by aiming directly at consumers, and avoiding explicit health claims.  Others seem to be leaning pretty heavily on the concept of being so disruptive that, in effect, the world will change for them.

I’d suggest that there still is a huge opportunity for digital companies that are keen to robustly demonstrate health benefits, at the high level of rigor that is standard in the medical products industry.Continue reading…

Lessons Learned from China

By John Halamka, MD

On Sunday I returned from a week in Shanghai and Hangzhou.   A remarkable trip that included daily meetings with government, academic, and clinical leaders.   What did I learn?

In China, about 5% of the GDP is spent on healthcare per year compared to 16% in the US.    Although there is wide variation in lifespan and other population health measures between rural and urban settings, there are few interesting observations about Chinese healthcare:

*It’s a single payer, publicly funded system that provides universal healthcare via a 14% payroll tax.

*There is a single national set of regulations and policies applied to all hospitals, clinics, and doctors

*There is a single set of national privacy laws

*Immunization is mandatory for the entire population

*There’s a single national healthcare identifier

EHRs are widely used in China, however they are optimized for episodes of care, using templates for capture of selected data elements specific to a disease i.e. hypertension, hepatitis, diabetes.    The volume of patients is overwhelming – in one hospital I visited (Huashan), the  dermatology clinic sees 4000 patients per day.    The Chinese EHR enables clinics to document the basics of a problem specific encounter, facilitating extremely fast throughput.   The downside of this is that there is not a longitudinal problem list, medication reconciliation, or coordination of care to avoid repeat testing.

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Capital Markets and Development Prospects are Bright Spots for 2012; Aging Facilities Pose Challenges

By Scot Latimer

Healthcare reform is creating a growing sense of uncertainty that will build in 2012. This will have an increasingly significant impact on strategic business plans for healthcare systems. It will spill over into portfolio and cost rationalization activities and the allocation of capital at hospitals across the country.

Certain areas of the industry are in fact harnessing that uncertainty. They are planning medical office and outpatient facilities that foster physician alignment demanded by reform.  Planning will progress steadily forward over the course of 2012, moving from “talk” to action, at levels not witnessed in 2011.  Health systems with the capacity and resources see this in two ways:

  • a necessary action to adapt to healthcare reform
  • a competitive advantage acting as a first mover.

M&A Activity Plays into the Hands of Investor Appetite

Hospital merger and acquisition activity will be a major theme in healthcare in 2012. This activity involves hospital to hospital combinations as well as highly prized physician practice groups.  But with M&A activity comes with a lot of real estate baggage.

In completing a merger, the healthcare organizations will look for ways to

  • create operational efficiencies and
  • rationalize their footprint to best serve their mission.

All of this is done while reducing the annual capital spend.  The net result is realigning their real estate portfolios. That takes planning as systems carefully evaluate how they are aligned with their business and operational strategies.

This will lead to strong levels of activity in the areas of

  • dispositions,
  • monetizations and
  • sale-leasebacks

The good news is there continues to be strong investor demand for healthcare related real estate, and we expect the product sector to remain much in demand in 2012 as the broader economy continues to struggle to re-energize itself. The proven track record of healthcare real estate through downturns and the compelling demographics of the sector will keep propelling activity and pricing levels throughout 2012.

While no asset class can be considered recession-proof, based on past performance and future projections, healthcare real estate is be about as ‘recession-resistant’ as possible which makes it a preferred class today.

Outpatient Care Opportunities are Areas for Optimism

In planning for accountable care, the industry continues to experience ongoing evolution. It is moving away from the planning and development of in-patient facilities to outpatient and ambulatory care settings that offer greater community access and lower capital and operating cost.

Healthcare reform keeps uncertainty a constant theme. The industry is responding to that uncertainty. Very few systems, or developers, are prepared to go full bore with plans. The pipeline of new projects is more limited than before. The planning and financing processes take a great deal of time, so other than obvious requirements, the activity may be muted for some time.

There is a bright spot:  outpatient facilities. Hospitals and healthcare systems remain committed to expanding their footprints outside of their main structures and into the communities they serve.

That market is coming back, and the design and funding of these facilities is evolving:

  • Gone are the 40,000-square-foot “doc in the box” facilities that used to be the industry model.
  • Now, it is not unusual as you aggregate services from larger employed physician models, to see facilities designed and developed that are in the 100,000-square-foot to 200,000-square-foot and up range.  This design and scale is more apt to attract capital and at lower cost levels than smaller and less creditworthy projects.”

Future planning for new medical office buildings will remain the busiest area of the business as hospitals and health systems look ahead, strategically, to have plans in place for when they can pull the trigger on a new project.

Planning and Performance are Critical

As hospitals and health systems look to expand into the communities they serve, enhance operational efficiencies and ultimately improve the bottom line,

The connection between real estate and operations will intensify, and planning will be even more critical to success.

Hospitals need to perform better and increase throughput. They need to do that without expanding capacity. That means a challenge: do more with less.

But with all that challenges healthcare, chief among the questions healthcare executives are asking is, “For which future should we prepare?”

Deferred Investments Loom Large: Aging Facilities Face Operational Challenges

Executives face considerable investment-related decisions related directly and indirectly to the physical plant.  The industry’s physical plant continues to deteriorate. Many hospitals and systems across the country have had to defer maintenance issues or initiate short term fixes to delay the inevitable. Why? Because of:

  • the financial struggles caused by reimbursement cycles,
  • the cost of funds and
  • other financial and operational factors

Average age of plant (an accounting measure relating accumulated depreciation to depreciation expense) tells the tale. It is the metric which best predicts the health of our facilities. By investing more into the plant, even at incremental levels, an institution can buy down the age.

Therein lies the problem … the average age of plant has risen nationally all but one year in the last decade.

Many institutions have had to ask―and will continue to have to evaluate―whether they are investing enough to at least maintain the average age. Unfortunately, in most cases, the answer is no. This has created a looming overhang.

We had hoped that with the investments of the last decade these problems would mitigate. But the steep decline in investment the last three years has us right back where we were 10 years ago. Further, the issue is not going away.

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