Proteus isn’t alone. Dozens of large and small companies are turning to wireless technology to achieve what the Obama administration is seeking through legislation: a health-care system that keeps people healthier for less.

Using wireless technology has the potential to reduce costs in part because part of the infrastructure already is in place. With more than four billion cellphones sold to date, a large percentage of the world’s population has access to devices and networks that can send medical data to doctors.

In addition to Proteus, the article notes wireless, intelligent medicine efforts including Corventis, the West Wireless Health Institute, Triage Wireless, Intel, Qualcomm and CardioNet.

I recommended one on Wal-Mart laying foundation stones for an interesting new health care delivery model.  Here was my submission:

Look at how Wal-Mart is becoming the new health care company of the 21st century. With initiatives to offer electronic medical record and pharmacy services to employers, inexpensive medications to consumers and instore/onsite clinical care to both companies and individuals, Wal-Mart is exploring a very new medical business model. It is one that relies not on selling health products and services as standalone things, but rather using them as essentially loss leaders to sell something else–groceries, toys, electronics, clothes etc. Just like Apple re-imagined what a song was to sell iPods and iPhones, Wal-Mart is re-imagining health products to sell consumer goods. And they have the distribution channel, market power and information technology to pull it off. Health providers, pharmacy benefit managers and pharmaceutical companies should take note.

BusinessWeek writer Greg Spielberg picked up the story idea and today published an article titled Wal-Mart Medical Clinics Stumble. A different theme than I had in mind, but very interesting nonetheless.  And it became the most read and emailed story of the day!  Spielberg reports:

Wal-Mart has more than 1 million potential clients among its employees alone, and it is betting that the combination of rising health-care costs and consistent traffic from budget-minded shoppers will prove successful. However, the enterprise has been marked by early stumbles and is taking longer than expected to develop. Industry experts and clinic operators cite brand confusion, advertising problems, broken partnerships, and the recession as factors in Wal-Mart’s halting foray in the field.

The stumbles reported are a reminder that all things new go through a challenge phase. However, the pieces of the puzzle for putting together a new health care delivery model are at Wal-Mart and appear to be a part of its strategy. Once they work out the kinks, this kind of alternative drug/care/services model could be one of the answers in health care reform.

You can get wireless data access just about everywhere these days, from your bathtub to Barcelona’s city streets, so why not in your body? Well, soon you will-or at least, that’s the vision of a handful of emerging biotech companies. As the Boomer generation ages, companies eyeing the overburdened U.S. medical systems see opportunities to extend the reach of existing medical care, free up health resources for those who need them most, and encourage long-term health and fitness using technology.

Profiles are included for CardioNet (mobile cardiac monitoring), Triage Wireless (wearable physiologic monitoring), Proteus Biomedical (embedded sensors in pharmaceuticals and medical devices) and Apple (iPhone sensors and applications for mobile health).

Of note in the article is a reference to the FDA recently hinting that it may consider regulating iPhone and other mobile health applications.  The source is MobiHealthNews, which detailed a session including the FDA’s Don Witters at the TEPR+ health IT conference earlier this month.  Mr. Witters was asked about the iPhone and whether or not it and other mobile health applications would be considered regulated devices.  MobiHealthNews writes:

At times during the session, the tension in the room was palpable. Witters declared that the FDA has jurisdiction over any device that diagnoses, treats or prevents a disease. This led to one question from the audience: “So an MRI app for an iPhone is a wireless medical device? Or a patient reporting their blood glucose level by text messaging their physician who then adjusts their insulin dosage with a return SMS?” Witters initial response was “No, I think that’s getting into information exchange-that’s different.” After the questioner thanked him and said that people probably just breathed a sigh of relief, Witters doubled-back. “Well, I think the real answer is ‘We don’t know.’ That’s why I’m here today to begin this dialog and see where [the FDA] fits.” So, the FDA could really be interested in inspecting iPhones for use as “wireless medical devices”? You bet.

The summary of Mr. Witter’s remarks goes on to say that his goal was to start a dialog to listen, discuss and begin to answer some of these important questions.  Let’s give high marks to the FDA for reaching out to begin a conversation with the mobile health industry and consumers.  There is a lot to discuss, as this Q&A attests.  Regulatory authorities clearly need to play an important role in defining the boundaries of what is inside and outside their domains, and mobile health and wellness experts need to advocate for definitions that maintain innovation and the rapid growth of this field for consumers and patients.

Medtronic's Reveal XT

new category of medical technology: “inserted” (in contrast to implanted) sensors that can be administered and removed quickly and are designed to continuously monitor physiology, diagnose disease and maintain health.

One day you will have one.  We all will, because this kind of in-body (but non-invasive) continuous health monitoring will play an important role in advancing us from Health 2.0 (individual-focused online health empowerment and collaboration) to what we can call Health 3.0 (direct, automated connection between an individual’s sensed physiology and his Health 2.0 tools and communities).  More on that sweeping prediction in a bit.

St. Jude Medical, like Medtronic one of the largest global medical device companies, launched its own insertable diagnostic device six months ago.  St. Jude’s Confirm product is also a cardiac monitor.  It measures unexplained syncope (sudden fainting and dizziness) caused by electrical disturbances in the heart.  Medtronic’s Reveal XT is a product line extension based on an earlier device, Reveal DX, which is also approved for diagnosing syncope and measuring cardiac rhythm abnormalities.

The Reveal and Confirm technologies have a number of other similarities.  Both have a wireless

St. Jude's Confirm

link from under the skin to the outside world.  This brings an individual’s monitored health information to a database and care management system (called CareLink by Medtronic and Merlin by St. Jude) that is used by physicians to receive patient-specific reports and analyze the diagnostic information.  Both devices can currently be inserted for up to a 3 year period.

These early applications of insertable monitoring devices are important.  Millions of people suffer from atrial fibrillation, which can lead to stroke, and unexplained syncope.  However, these are first generation, niche applications that do not do justice to the broad potential such technologies represent.  Having a sophisticated computer-based sensor device under the skin and limiting it to watching heart beats is like having an iPhone and using it only to make calls….or like going to the App Store with that iPhone, and feeling content with just downloading Pong.

Future product development for subcutaneous sensors will prepare them for broad health and wellness usage along three dimensions.  First, the evolution from implantables to insertables will evolve yet again to tiny but powerful “injectable” devices.  The requisite miniaturization know-how exists today.   This will break down the adoption barrier for even simple outpatient surgical procedures and for devices that can be felt and seen under the skin.  Second, the breadth of sensed physiologic parameters and device functions will increase to make the products more valuable and desirable, from additional body systems and molecular profile monitoring to medication and drug response tracking to activity and fall detection to direct mobile phone linkage to personal health record storage.  Third, the access to sensor information will expand from its current focus on providing the physician with patient data to providing the individual herself with the sensed data for whatever use she chooses: use it as the basis for personal health decisions, auto-upload it into her favorite online patient and wellness community sites, set up family and other caregiver support systems, etc.

As the form factor, features and openness of these technologies increase in this manner, we will transition from the current, limited focus on diagnosis to one of disease management.  Disease management will then transition to wellness management.  And that is when we will all have one.  Just as most of us could not now imagine a life without the mobile phone in our pocket, in the future there may come a day when we can’t imagine not having the ultimate mobile computer device under our skin.  And then we will be in a Health 3.0 world.

Note: others have used the term Health 3.0 to capture the future link of commerce to health content and community.  We believe this definition heads in the wrong direction, taking us away from a patient and health-outcomes centric definition.

Therapy on my mind

This demonstrates yet again that adherence and persistence to pharmaceutical therapy is essential to health outcomes.  Or in the words of former U.S. surgeon general Dr. C. Everett Koop, “Drugs don’t work in patients who don’t take them.”

But there has also been some interesting commentary about the findings, challenging that the statins were responsible for the health benefits observed.  The Coronary Drug Project of the 1970s, for example, showed a benefit from faithfully taking a placebo that was almost as high as consistently taking active lipid-lowering drugs.  What’s going on here?  An incorrect conclusion to draw would be that the right mindset alone is the key to conquering disease.  It isn’t.  Or that drugs do not play a central role in the battle.  They do.

Dr. Mark Hlatky, a professor of medicine and health research and policy at Stanford University, has the insight:  ”It is definitely a very important observation that people who take their drugs always do better than people who don’t, even if the drug is not terribly effective, because they tend to take care of themselves better in a lot of ways.”

Engagement in one area of positive health decision making (drug adherence) has a multiplier effect in healthy behavior overall (diet, exercise, other lifestyle choices).  So if pharmaceutical products are effective, even modestly so, and the problem of medication adherence can be solved, this can have a profound effect by making pharmaceutical therapy the catalyst for better wellness management and disease prevention.  The so called “placebo effect” could therefore be thought about and used in a positive way, by harnessing the beneficial effects of attitude and expectations toward therapy in the delivery and support of effective pharmaceuticals.  With this as a guiding principle, pharmaceutical developers should focus not just on innovation to make new drugs, but on innovation around and beyond the drugs they already have.

Few companies are doing this today, but it is the future of the pharmaceutical industry.  It will require developing not just individual drugs, but “pharmaceutical systems” that support and empower consumers to take their medicines correctly and physicians to personalize the drug regimens they prescribe.  It will also require integrating sensor and information-based tools about drug taking behavior and physiologic response into pharmaceutical products, and making consumer communications and support-based services a part of the pharmaceutical business model.

Each of them position Twitter’s growing impact on health care in the context of how social networking tools are changing the way we as individuals interact with our health, disease and caregivers. If Web 1.0 was about accessing information, Web 2.0 (and its favorite child, Health 2.0), is a combination of technologies and content that has shifted the web from a collection of sites with information to a collection of communities in which individuals interact with and influence one another in open collaboration.  It is about the user and her neighbor (whomever or wherever that neighbor may be), not the website or the company.

Twitter in the Tree of Life

Twitter is a leading example of these trends.  A Twitter user writes, or “tweets”, what they are doing or thinking at a moment in time in 140 characters or less, and this information is immediately transmitted among groups of selected friends, colleagues and interested individuals in that user’s network.  The value here is something you need to actually try to really appreciate.  What becomes rapidly apparent is that this is a whole new mode of communication: open, immediate, continuous, distributed, global communication between groups of like-minded and motivated individuals.  What results is a bit free form and random at times, but trends toward a kind of collective intelligence on issues and topics.  The Intelligent Medicine Blog has jumped in too, and you can follow us on Twitter for more thoughts on technology, communications and health.

This collective intelligence has made Twitter and other micro-blogging sites natural tools for health-related communication.  There are some excellent examples that have already grown deep roots. Take public health, for example.  The American Red Cross and the Centers for Disease Control are big on Twitter.  The Red Cross used Twitter in 2007 and 2008 to send minute-by-minute updates and instructions on California wildfires and deliver aid to large numbers of geographically dispersed and diverse people.  It is not a great leap to go from this instant communication and community collaboration in cases of public health and safety to Twitter-based solutions for the health and safety of individuals struggling against a newly diagnosed disease or battling through the years against a chronic condition.  The collective intelligence of a community of like-minded individuals can help them as well.

Current health care-related uses for Twitter tend to focus on the publishing of health-related information (such as from care providers like Mayo Clinic), community discussions of medical and wellness topics (such as a group focused on breast cancer and another for people with bipolar disorder) and an increasing number of personal health-tracking sites.  Some interesting tracking examples are Twitter-cise (for exercise support and reinforcement), Tweet What You Eat (for diet and calorie tracking) and Qwitter (for social-based smoking cessation).  The future of micro-blogging in health care, however, will likely move far beyond these tracking-based support offerings and toward population-based tools that can (1) change the standard of care for disease treatment, (2) enable users to prevent disease and slow disease progression and (3) form a foundation for large-scale data analysis of health and disease treatment-based behaviors and outcomes.  These next-generation uses of Twitter-like tools will have feedback and learning features that can tap the immediate and collective wisdom of users who share a common condition, combined with automated health and care instructions that can serve as a virtual and ‘always there’ wellness coach.

An early example of this is SugarStats. A person with diabetes can use this site to enter their health data using Twitter and other portable input devices.  SugarStats allows a user to track his sugar glucose levels along with other variables that affect those levels like medications, food intake and physical activity.  Users can then share this information rapidly with their self-defined community of family, friends, health care professionals and other diabetics for support, advice, reinforcement and guidance.  In the future, this type of tool could be used (with the user’s permission) to alert a user’s community if his entries suggested something out of bounds, to automatically feedback information and guidance based on diabetes community standards, and to support the user to make better health decisions throughout the day.  This could also be transformational for medical product developers.  Imagine a pharmaceutical company that has developed a new diabetes drug receiving continuous feedback on the medication from millions of tweets on its effectiveness, side effects and real world use in the day-to-day lives of consumers.  That is dramatically more powerful than any clinical trial used today.  The collective wisdom of groups is smarter than the smartest people in them, and this will be invaluable to the patients, clinicians and medical product developers of the future.

Here is a summary of the major conclusions, as summarized by e-patients.net:

1. e-patients have become valuable contributors, and providers should recognize them as such.
“When clinicians acknowledge and support their patients’ role in self-management … they exhibit fewer symptoms, demonstrate better outcomes, and require less professional care.”

2. The art of empowering patients is trickier than we thought.
“We now know that empowering patients requires a change in their level of engagement, and in the absence of such changes, clinician-provided [information] has few, if any, positive effects.”

3. We have underestimated patients’ ability to provide useful online resources.
Fabulous story of the “best of the best” web sites for mental health, as determined by a doctor in that field, without knowing who runs them. Of the sixteen sites, it turned out that 10 were produced by patients, 5 by professionals, and 1 by a bunch of artists and researchers at Xerox PARC!

4. We have overestimated the hazards of imperfect online health information.
This one’s an eye-opener: in four years of looking for “death by googling,” even with a fifty-euro bounty for each reported death(!), researchers found only one possible case.

• “[But] the Institute of Medicine estimates the number of hospital deaths due to medical errors at 44,000 to 98,000 annually” … [and other researchers suggest more than twice as many]
• We can only conclude, tentatively, that adopting the traditional passive patient role … may be considerably more dangerous than attempting to learn about one’s medical condition on the Internet.” (emphasis added)

5. Whenever possible, healthcare should take place on the patient’s turf. (Don’t create a new platform they have to visit – take yourself wherever they’re already meeting online.)

6. Clinicians can no longer go it alone.

• Another eye-popper: “Over the past century, medical information has increased exponentially … but the capacity of the human brain has not. As Donald Lindberge, director of the National Library of Medicine, explains ‘If I read and memorized two medical journal articles every night, by the end of a year I’d be 400 years behind.”
• In contrast, when you or I have a desperate medical condition, we have all the time in the world to go deep and do every bit of research we can get our hands on. Think about that. What you expect of your doctor may shift – same for your interest in “participatory medicine.”

7. The most effective way to improve healthcare is to make it more collaborative.
“We cannot simply replace the old physician-centered model with a new patient-centered model… We must develop a new collaborative model that draws on the strengths of both systems. In the chapters that follow, we offer more suggestions on how we might accomplish this.”

Bigger Giant, Same Clothes

These deals bought Pfizer the blockbuster drugs Lipitor, Celebrex and Bextra, but the impact on innovation has been striking.  During this same period, Pfizer invested $60 billion in R&D, but launched only one new product with revenues exceeding $1 billion.

While most major pharmaceutical companies are struggling with these issues, some are exploring a very different path to innovation in response.  Johnson & Johnson, for example, recently created the Office of Strategy and Growth to develop major businesses that enter new markets and leverage the drug, device and consumer product diversity and strengths of the company.  The direction of this strategy has become clear over the last few months, and it shows J&J moving quickly and aggressively into information-based, patient-centric medicine and wellness management.  In October of 2008, J&J launched a Wellness and Prevention Platform with the acquisition of HealthMedia, a leading behavioral medicine company that offers web-based, automated coaching for wellness, disease management and health interventions. (Note the impact technologies like this can have on patient outcomes in our Connecting with Connected Health post).   This was followed in December with the acquistion of the Human Performance Institute, a science-based health, productivity and performance training company.  J&J spoke of both acquisitions as being central to its growing focus on the health and wellness management needs of large employers, health plans and governments.  The company clearly sees a multi-billion dollar opportunity in providing solutions for these entities that are on the front lines of dealing with ever-increasing health care costs.

J&J is also positioned to link the new wellness and prevention platform to its portfolio of medical devices and pharmaceutical products, creating treatment systems that could redefine standards of care and outcomes…and have the potential for billions more in new and differentiated products.  Think about its LifeScan blood glucose meters linked to HealthMedia virtual diabetes education coaches on a diabetic consumer’s mobile phone, for example.  Or patients implanted with its Cypher heart stent receiving drug adherence monitoring and automated coaching for their anti-clotting therapy and recommended diet and exercise regimen, leading to an integrated system of device, drug and behavioral medicine.  This approach, focusing on new paths to innovation and growth and not just more of the same, can make even giants dance.

“The dogmas of the quiet past are inadequate to the stormy present.” President Lincoln

“What the cynics fail to understand is that the ground has shifted beneath them.” President Obama

On this, an historic inauguration week in the United States, where dogma and cynicism have been quieted for a brief and welcome moment, consider health care.  Is the present very different from the recent past? Has the ground shifted?  Will new solutions fill the vacuum of a broken system?  Or is a new approach like intelligent medicine simply an innovator’s dream, with the barriers and limitations of physicians, payers, regulators and industry leading to yet another rude awakening? The answer: the transformation of health care is inevitable, and it is has already begun.  That’s not a campaign slogan.  It is a recognition of the shifting structure of needs, demands and power within the health care system.

To be sure, over the last twenty years change has been thwarted again and again by structural realities in health care that seem immune to progress.  Among many, two stand out.  First, the system reflects a culture of disease, not health.  The payment and reimbursement structure is for office visits, procedures and interventions, while that for health, maintenance and prevention is limited.  As a result, physicians need to treat as many patients as possible in face-to-face sessions, limiting the time, efficiency and quality of the average interaction significantly.  Hospitals focus on investments that generate procedure and intervention-based revenues, and can actually be penalized financially by quality that keeps patients off the wards and out of the surgical suites.  And medical product developers direct their innovation toward potential products that fit within this existing structure, such as expensive specialty drugs and surgical instruments that are focused on heroic, end-of-life care for a relatively small percentage of patients, not those struggling for years with the self-management of a chronic condition.

Second, in many ways the system rewards incrementalism, not breakthroughs.  Medical product companies have been required to bring new drug and device products to market through a regulatory system based on narrowly defined trials in small, highly selected clinical populations that do not reflect the general population or how these products will be used in the real world.  On approval, we have then been able to largely dictate pricing and use, broadening the intended market over time and generating enormous profits, with little post-approval surveillance on actual health benefit and potential safety issues.  This combined with the event-driven financial structure discussed above means there has been little incentive to invest broadly in new models of product development, care delivery, product personalization and outcomes assurance.

But in recent years we have seen the elements of fundamental change building.  Picture each of the key players and what they face in the stormy present. The FDA is an agency between a rock (pressure by patients and industry to speed important new product approvals for unmet medical needs) and a hard place (outrage in government, media and society when approved drugs turn out to cause harm not detected in clinical trials).  To save itself, the agency is beginning to advocate for a new drug development paradigm that integrates modern molecular and information technology tools. For pharmaceutical and other medical product companies, pricing power has shifted dramatically beyond their control.  Medicare and private insurers have increasingly sophisticated databases of real world product usage, outcomes and safety; regardless of what the clinical trials reported, payers are now determining on their own how valuable a new product is, whether or not they will allow coverage, and what price is justified.  In response, pharmaceutical companies are now investing agressively in ways to personalize their products and build outcomes into the product systems themselves, in many cases using biomarkers, sensor-based devices and information technologies.  For self-insured large employers, rising health care costs are unsustainable, leading to enormous political pressure to change the system and determine new models of care management, delivery and reimbursement.  For physicians, particularly in primary care practice, the pressures of the current health care system and the inability to fully care for their patients in the way they desire, are also leading to movements for change. With all these pressures from within the box of the current system, the lid is beginning to open,  and next generation health initiatives, technologies and solutions are beginning to break out.

Let’s start with the inability or disinterest of many individuals to use health monitoring and therapy optimization innovations that would allow them to play a greater role in managing their own care.  Our reader commented: “Unfortunately, I think the majority of the population is just not motivated enough to take a proactive role in their health care, especially in preventive health care, unless they have immediate financial incentives.”

We discussed this topic with Dr. Joseph Kvedar, Director of the Center for Connected Health, a unique organization formed by Partners HealthCare to engage patients, providers, payers and policy makers on new ways to deliver quality care outside of traditional medical settings.  Dr. Kvedar talked about two small studies that have preliminary, but very relevant findings.  The studies looked at different technology-based patient physiologic monitoring and personal data-driven coaching interventions.  The coaching included the use of online communications and virtual, computer-based intelligence coaches.

Say hello to your virtual coach

He noted that the studies show simply providing accurate physiologic information to an individual has almost no benefit on its own.  However, Dr. Kvedar continued, “By monitoring a relevant physiologic signal–like blood pressure or whether you took your medications or not–and presenting that information to the individual in a way that is maximally engaging to them–such as in a dynamic website–we estimate that 10% of individuals will move to a healthier behavior.  These are the ‘manage what you measure’ types and what they need is the measurement presented in the right way.  If we add data-driven coaching, meaning that the individual feels that someone–virtual or real–is helping them, the percent of individuals that will move to a healthier behavior goes up to 50 or 60%.  The remaining 40 or 50% are probably people who are not yet ready to contemplate that they need to change behavior to become more healthy.“

This research suggests that the right technology products, implemented in the right way, might be adopted by a majority of people.  A requirement is that the new connected health tools are designed to be highly personalized and connected to data-driven support at the same time.  The reader’s comment also points out ways to capture and support even more people, perhaps even the lagging 40-50% Dr. Kvedar mentioned: incentives.  We have financial, social, aspirational and other incentives as part of most of our daily decisions, and health and wellness should be no different.  For example, if I take my medications as prescribed and monitor and share this through a connected health system, and if this personal behavior slows or prevents my disease progression in a way that reduces expensive interventional care in the future, shouldn’t I be rewarded for that by health insurers, employers and product innovators with lower copays, free or reduced priced medicine, wellness rewards or other incentives?  There are many studies underway to test incentive-based behavior change, some integrating novel connected health tools.  An article published last week in Technology Review describes a program at the Innovations in International Health project at MIT, where tuberculosis patients using a medication adherence diagnostic device tied to mobile phones are rewarded for their drug taking consistency with cell phone minutes.  If we develop connected health products and systems with the right features, support and incentives, real people will use them.