At the beginning of 2009, I announced that I would be participating in the Scripps Research study on the impact of knowledge of one’s genetic disposition to behavior. In other words, does advanced knowledge of genetic disposition change behaviors of consumers to mitigate that disposition?  This is a multi-partner research effort that includes Scripps Research, Navigenics, Affymetrix and Microsoft HealthVault.

Purpose of my participating is to first gain a better understanding of such direct to consumer (DTC) genetic testing services and secondly, see how such information may be used in the future within the context of a Personal Health Account (import SNP data into HealthVault).

The Experience:

Thankfully, I was not in a rush to get the results as it took Navigenics nearly three months to turn this around, though Navigenics did inform me up-front that it would take some time as they would release results to all participants at the same time.  But alas, I finally received an email with a link to the site wherein I was dutifully asked to securely sign-in.  Note: security password requirements are quite strict.

After logging in, Navigenics provides a thorough educational review of how the data will be presented, which consists of gray and orange boxes.  These boxes give the estimated lifetime risk for each of the 22 conditions (ranging from Abdominal Aneurysm to Stomach Cancer) that Navigenics currently tests for.  They add additional tests to their service as research dictates (new genetic markers identified and reported upon in peer-reviewed research papers).

Having a gray box for a given genetic disposition is good as it signifies a relatively low genetic risk to a specific disease.

But those orange boxes are the ones you really need to look out for as according to research studies that Navigenics researchers deem worthy, your genetic make-up signifies an overall risk that is either higher than 25% or your risk is 20% or more higher than the rest of the population.

Prior to reviewing results, Navigenics makes many statements to the effect that don’t go off and do something drastic based on your results.  They also provide you the opportunity to selectively choose which results to review.

When reviewing results, Navigenics does a very good job of providing information about a specific disease, what the results mean, how they were obtained and the relative ratio of genetic disposition and environmental risk factors in contracting the disease.  And for those that are particularly inclined to the science behind the findings, links to specific research papers on a given gene and disease association. Quite an impressive amount of information that Navigenics provides to the consumer.  In addition to this online information, Navigenics offers genetic counseling, via phone, to go over the results and their implications. This is particularly helpful for those whoe results may point to an extremely high risk of contracting a fatal, yet treatable disease.

Always looking for the biggest bang for the buck, I selected all 22 tests/conditions.

Now I am not going to share the specifics of those tests but what I will share is my disbelief and deep concern about such DTC genetic testing services.

Prior to going through with this exercise, I spoke to Prof. Rudolph Tanzi of Harvard and author of Decoding Darkness who just happens to be one of the researchers responsible for finding the first Alzheimer’s gene.  Prof. Tanzi was quite frank basically stating that such services are simply a modern form of snake-oil salesmen.  His primary argument against such services is that the science is simply not mature enough to make any predictions as to future genetic risk.

The problem is that for every gene that may put you at risk for a given disease, you may also have a countervailing gene that has yet to be discovered that cancels out that bad gene.  Thing is, today we know so little about the interactions between genes – we are in the “stone age” of genetics.  I also was not that comforted to learn that in all those gray and orange boxes for which you were compared against a broader population, that population consists of a meager 60 Americans of European descent who have participated in the HapMap Project. Hardly representative, so I’m not placing too much credence to any comparisons to the population in my results.

Digging deeper into one specific disease, Diabetes Type-II,  I showed a high risk with 15 of 22 markers for this disease found in my genetic code.  Nervous? Concerned? Rushing off to make an appointment with a doctor? Combing the Internet for more information on this disease? No, I have done none of these things for contrary to the results, I do not believe I am at risk.

Why this laissez faire attitude?

I know of no blood relatives on either side of the family that have ever contracted diabetes, period!  It simply does not exist in my family-tree so I can only conclude that there are quite a few genes in my genetic make-up that have yet to be discovered which are firmly putting the brakes on those 15 markers that, according to research, put me at risk.

Which leads me to wonder: If the Navigenics test for diabetes delivers such poor results (Note: Navigenics tests for 22 diabetes markers, a significantly large number of markers compared to other disease tested for, e.g., heart disease has only 4 markers), are the other diseases tested for even more suspect?  Willing to place a very big bet that the answer is yes.

Therein is the risk for the general population who may embark on such a genetic adventure.  After receiving their results, might a consumer take actions unwarranted or worse, put them at even greater risk.  We are not in just the “Stone Age” of genetic research, we are at least that far back, if not greater in the knowledge among the general public, including physicians, on what genetic tests results truly mean.  We are simply not there as a community to make any drastic decisions at all based solely on genetic test data.  That’s not to say we can’t go forth and simply live healthier lives: eat well, sleep well and exercise, advice often given by Navigenics to control environmental risk factors.

But as pointed out in the previous post, maybe we need to think differently about what might be the potential value of performing such a genetic tests such as personalized medicine, clinical trials recruitment, etc.  To enable such activities, the ability to export one’s genetic information into their personal health account is necessary.  Unfortuantely, despite the partnership with HealthVault, Navigenics did not provide me an option to upload my SNP data to my HealthVault account.  Hopefully, this is forthcoming and when it is, I’ll report on that experience as well.

For another perspective, encourage you to read Berci’s experience with Navigenics.

Breaking down Wellness efforts into three models; traditional, heavy-handed top-down, specific games to encourage and engage the consumer in Wellness activities and developing games that are first, FUN than inserting Wellness into the fun.  If any of you have been to CrumpleItUp, you will know where their hearts and souls lie – let’s make it fun, let’s make it engaging and healthy behavior will be an outcome, naturally.

This is in part why their Freewheel!n effort was such a success. Freewheel!n got folks back on bikes, something they may not have experienced in decades, reconnecting them with their youth and the joy, freedom and simplicity of riding a bike (full disclosure, I am an extremely avid cyclist).

But what may be the real challenge of any Wellness program is how to make them sustainable over the long term to truly impact and change behaviors that most likely evolved and have been in place for years, if not decades.  It is not like we just throw a switch and the consumer changes their behavior.  Sure, under top-down Wellness programs from say an employer, incentives may be provided that an employee will readily capitalize upon and change behavior in the short-term.  But what happens when that program is discontinued, or the employee changes employers?  Do they continue those healthy habits without the incentives?

To make Wellness systemic and truly change behaviors we do need to make Wellness fun and as CrumpleItUp articulates in their post, embed that healthy fun behavior into activities that consumers are already doing, maybe giving a nudge in the direction for them to do more. Setting up peer-to-peer (P2P) contests is one approach which CrumpleItUp is doing with Horsepower Challenge.

Recently, Sean Nolan of Microsoft’s HealthVault group wrote a post on what one of their developers did in building a HealthVault app called, Walk Me. Walk Me is similar to the Horsepower Challenge in that it focuses on just walking, but unlike Horsepower, Walk Me looks at bringing together peers based on BMI and age wherein one can see how they compare to others in their physicial activity of simply walking. The BMI and age data is based on their HealthVault profile. As this is completely consumer opt-in there are no privacy issues/concerns, it is a consumer’s choice whether or not to participate.

Taking this all one step further (no pun intended) Wellness programs such as this may also cater to our inner desires to leave this world just a little better off than we found it.  As I mentioned to Sean when he informed me of his post, I like it Sean, but why not tie all those steps walked to say some charitable program like FreeRice, donating a grain of rice for each step walked or in a similar vein a penny for each step to an organization like Kiva.org.  One could even set-up friendly competitions between groups as to who might ultimately contribute more to such humanitarian relief efforts.

“We cannot live only for ourselves. A thousand fibers connect us with our fellow men.”

- Herman Melville

There is so much more that we, as a wealthy nation, even during these tight times, could be doing at an individual level to improve not only our health, but world health.  Time to get walking.

Interesting concept but half-baked.  Sure, it may be nice to get some feedback on a given workout but is it really all that useful if you do not have any biometric data to go with it?  And what is a “health professional” anyway, a recent graduate of We Are Physical Therapy University?

We’ll have to wait and see what ultimately arises from this initial trial balloon.

In a broader sense, it really is a brilliant idea that may quickly move beyond the shores of Japan to North America.  We can readily foresee employers and payers adopting a Wii Health-type of service combining the Wii, with the bi-directional communication capabilities to health coaches and maybe even to a consumer’s PHR.  HealthString is one such PHR that has a heavy focus on health coaching and sells their product/services almost exclusively to employers. One can easily imagine an employer who offers HealthString to its employees combining their health coaching service and PHR with an incentive/rebate on the purchase of Wii Fit to foster healthy behaviors among its employees to improve overall population health.

Or maybe, again via a rebate program, an employer can set-up an internal team challenge using something like Limeade (another health solution targeting employers), combining their solutions with the bi-directional communication and logging of work-outs capabilities of Wii Fit to promote peer-based fitness.  Clearly, there are all sorts of permutations and scenarios of services that one can build upon with the Wii Fit and this future bi-directional communication capability.

Makes us wonder if Nintendo has had any discussions with the folks at HealthVault and their Connection Center.

Oops, HealthVault is owned by Microsoft with its competing Xbox.  Nintendo, better look to Google Health and Dossia, both would be receptive to their overtures.

Purpose of presentation was to give these engineers a broader perspective on trends occurring in the HIT sector, and specifically trends in consumer-facing HIT.  As Chilmark Research has been conducting extensive research on Cloud Computing in healthcare, for our next report, much of the presentation focuses on the personal health platforms (PHPs) Dossia, Google Health and HealthVault. The presentation also draws upon past research on PHRs and the inevitable convergence of the two.

Warmly welcome your feedback on the presentation, whether it validates what you are seeing in the market or if there is something we may have missed.

This got me to thinking last night that the real long-term value of genetic testing may not be in understanding one’s predispositions to specific diseases, though that is what the Scripps study (and Navigenics marketing) is focusing on.  Rather, the true value (or at least larger value proposition) may come in a few years time when this rich genetic information is combined with one’s medication regime to develop a more personalized and effective medication protocol.

Dr. Eric Topol of Scripps will lead the research project.  Navigenics provides the test kits and initial assessment (basically, you get a year subscription to Navigenics’s service, normally $2500. for a BIG discount). Affymetrix provides Navigenics with DNA tools to perform the analysis and all participants will receive a HealthVault account to store the information in a personal health data repository.  Scripps is hoping to recruit 10,000 participants.

In late October I received an invitation to participate as a “friend of Scripps” in this research study.  After much hemming and hawing, I decide to register to participate in Late November. My justification for registering was to use myself as a Guinea pig to report on, via posts here, what it is like to go through a genetic test process, the impact, or lack thereof of receiving the results and might the results be useful, if at all, once they are in a HealthVault account. For my price of admission, I’ll get a one year subscription to the Navigenics service,testing for disposition to at least 23 diseases (more may be added over course of year) but without the usual counseling service.

Why the initial reluctance to participate?  That reluctance stems from the simple fact that genetic testing is still very much in its infancy.

Today, there are a substantial number of genetic researchers that find such services as Navigenics, 23andMe, deCODEme as a load of hogwash.  In speaking with one of these detractors, Dr. Rudolf Tanzi of Harvard and MGH who also happens to be the co-founder of two of the four genes that have been conclusively identified to late onset Alzheimer’s and author of “Decoding Darkness: The Search for the Genetic Causes of Alzheimer’s Disease.” Obviously, no slouch when it comes to the topic of genetics.

Tanzi’s biggest gripe is based on a simple premise: How can a company (such as Navigenics) even begin to give a consumer a relative ranking on predisposition to a disease when there is so little evidence?  For example, in his area of study researchers have identified some 350 candidate genes that may influence contracting late onset Alzheimer’s.  Researchers know very little about any of these genes today and even more importantly, have virtually no understanding of the interaction between various genes and in particular genes that may be present which offset more lethal genes.

Navigenics thinks they have developed a statistically valid approach to get around this problem,  First, they only test for those diseases where they believe the research is comprehensive enough “meets their review standards” to test for specific genes (note: Alzheimer’s is in that list, something that Tanzi thinks is absolutely nuts) and secondly, they combine the genetic test results with what information a customer provides via an in-depth online questionnaire on health and family history.

Getting back to me, the genetic testing Guinea pig and the process so far…

In signing up for the test, I had to review and agree to the Terms and Conditions and Informed Consent (some 21pgs in all) for the research project.  The documents had all the usual disclaimers, legalese, assurances that privacy will be paramount (though Navigenics had a loophole stating that by agreeing, you can not sue them if they inadvertently release your data – gee thanks) and more than a few warnings to be careful as results may effect one’s emotions.

After this sign-off, next was the HRA (health risk assessment).  This was a very comprehensive HRA with many questions beyond my ability to answer, e.g., health and susceptibility of various distant relatives to all sorts of specific diseases.  Took a good 30-40 minutes to answer all the questions – this sucker was LONG.  Honestly, after answering the questions, one could put a consumer into a pretty tight box as to what they may or may not need to watch out for in the future.  It may well be here that Navigenics draws the vast majority of data/information in performing an assessment with the genetic test more of a gee whiz, ain’t that cool type of thing.

Couple of weeks later, received a nondescript little white box.  Inside was the saliva collection kit and packaging to mail kit back.  Went through the process and last week, received an email from Navigenics stating that the sample was at the lab undergoing analysis.  Results are guarnateed to be available no later than April.

Looking ahead, Scripps will be requesting that I take another HRA at 3 months and 12 months after receiving the results to determine if there has been any behavioral changes made as a result of new knowledge of genetic dispositions. After that, Scripps may contact me sporadically over the next 20 years to see if there have been any other behavioral changes.

What I’ll be particularly interested in, and will post on in the future are the following:

• Does knowledge of predispositions to diseases affect my behavior? Right now, I’m on the fence in this regard and really do not have a clear picture as to how I might respond.
• Will there indeed be any emotional repsonse to receiving the tests results?  I already know that being fair skinned, the sun is no friend on mine, but what about things I may not know?
• How is this information communicated and in particular, what will actually show-up in the HealthVault account?  Will that data/information transmitted to my HealthVault account be useful (leverage) in the use of other health apps, e.g., TrialX for clinical trials?
• More broadly, what does the research at Scripps show?  Is there any correlation between knowledge of health risk(s) and behavioral changes?

It will be an interesting journey over the next 12 months or so and I promise to keep you posted.

While the press release states that this is being offered to all 25M+ members of UHG, it raises all sorts of questions.  A few which we hope to have answers for next week when we speak to Optum are:

• Just how many UHG members are actively using the OptumHealth PHR today?
  
• Exactly what types of data will be portable?  Is it everything that resides in a member’s PHR (e.g., claims, maybe PBM, HRA data) or some subset thereof?
• When will this be made available, is it live today or will it be phased in?
• What is the business case for making this happen?  Is this something that employers are asking for or are there other justifications?
• Will you be making similar announcements in support of Google Health and Dossia (Dossia is a bit of a no-brainer)?
• How will data flow between the two systems (publish/subscribe model – RSS, Atom, etc.) and what will be the data standard used?
• How will you be positioning and advertising this capability to Optum PHR members?
  

We’ll put up a more in-depth post next week, provided OptumHealth is forthcoming with answering our questions.

demographic information, active medication lists, their allergy data, lab results, radiology results, personal problem list, past visits, upcoming appointments and inpatient/outpatient documentation

This data will be drawn from the military’s EMR, AHLTA.  Chilmark Research is assuming that the military took a similar “roll-your-own” (RYO) approach to building the PHR, to interface with their propriatary, RYO EMR.

Beneficiaries will be able to choose between Google Health or Microsoft’s HealthVault as the repository of choice for their health data.  The PR also quotes Markle’s Connected for Health framework as guidance for addressing privacy and security of health records.

As great as this announcement appears on the surface, afterall, 9.1M potential users across the entire military is a very big number, eclipsing Dossia by ~1M, currently the DoD is doing a very limited roll-out of MiCare to one modest-sized, military hospital (Madigan Army Medical Center) in Tacoma WA.  At this time, the DoD has not announced a broader roll-out schedule and until we see that, it remains to be seen just how big a story this really is.

The Cleveland Clinic-HealthVault announcement is distinctive in that it focuses on chronic disease management, via telehealth, through use of HealthVault’s unique Connection Center. With some 50 devices from 9 vendors, the Connection Center allows the consumer to upload device data (e.g., glucose readings, heart rate, blood pressure, weight, peak flow, etc.) directly to their HealthVault account. In the Cleveland Clinic project, which began last week (Nov. 3rd), uploaded biometric data from HealthVault compliant devices will automatically be pushed to Cleveland Clinic’s EMR and subsequently exposed to the physician for patient tracking and follow-up.

Had a call this morning with Microsoft and one this afternoon with Cleveland Clinic who both shared further details on this announcement:

A target of 460 Cleveland Clinic patients will participate representing three distinct disease categories; hypertension, diabetes and heart failure. The roll-out is across the Cleveland Clinic Integrated Delivery Network (IDN) and not just hospital patients. Clearly, they are focusing on the big chronic disease categories that result in huge costs that many believe better telehealth monitoring can mitigate.

• Hypertension patients, of which there are 400, will measure blood pressure only.
• Diabetes patients, of which there will be 30, will use five devices to measure glucose, blood pressure, peakflow, pedometer and weight.
• Heart Failure patients, the remaining 30, will use four devices to measure blood pressure, peakflow, pedometer and weight.

Pilot will initially be for an extremely short 90 days. Cleveland Clinic expects to have all patients active within 4-6 weeks. Not sure what they can accomplish in 90 days, maybe Cleveland is just hedging their bets to see if patients actually comply with the prescribed measurement and upload regime. Assuming that all goes well, one can guarantee that this pilot will be extended for at least a year, if not longer, as that is the only way they will be able to provide some demonstrable results that are publishable (something that Microsoft emphasized) and ultimately may influence future legislation (e.g., CMS funding), health plan reimbursement (P4P), and broader adoption among other Integrated Delivery Networks (IDNs).

Devices are being provided for free to trial participants. The only requirement, beyond the obvious willingness to diligently take their measurements, is that they have a Windows-based (XP SP2) computer and broadband access. Unfortunately, many heart disease patients are among the elderly and it is questionable as to how many have this capability. Still, the point here is to demonstrate, not solve all the problems and it is a good start.

Cleveland Clinic is training patients on the use of the devices(s), and data upload process to HealthVault, that is subsequently pushed to Cleveland Clinic’s EMR. Part of that training includes clearly notifying the patient when a particular reading should prompt a call to their doctor or even 911. Along with providing the device(s) and training, the physician will prescribe to the patient their measurement protocol (e.g., 2x/day, 3x/week, etc.) unique to that individual and the condition they are managing. Patients trust their doctors so receiving the package directly from their physician during an office visit makes a lot of sense and should encourage use and hopefully compliance. It will be interesting to see how compliant patients are to the prescribed compliance regiment as this is often a critical stumbling block. Will incentives be required?

Cleveland Clinic put in the upfront effort to understand how best to incorporate this new data stream into a physician’s workflow to minimize the burden. Specifically, the physician will receive a weekly notice notifying them that their patient(s) biometric data is ready for review. One click later and the physician is in the EMR reviewing their patient’s data for that past week. Prior to this pilot, Cleveland has experimented with other telehealth systems, but none were able to provide this level of integration with the core EMR system (always a stand-alone, silo’d operation) and thus saw little adoption among physicians. This is absolutely critical! Having spoken to many physicians about the success, and most often failure of telehealth initiatives, it nearly always circles back to lack of true integration to existing practices/workflow. Looks like this pilot tackles that issue head-on.

So what is the Business Case?

Wrapped up my conversation with Cleveland Clinic’s CIO, Dr. Martin Harris, (thanks again Martin for your time) by asking him: So what is the business case for this initiative? He outlined two areas where they see a benefit to Cleveland Clinic:

Service Case: In moving to this model of combining telehealth with traditional in-office visits they intend to completely re-design the office visit resulting in a better, more engaged and customer friendly process. This process will lead to higher customer service ratings, customer recruitment and higher customer retention – all important top-line metrics. They also see a service case for the physician as such a “system” will allow the physician to deliver a higher level of proactive care with their patients. Its all about market differentiation, distinguishing themselves in an increasingly crowded market – one that will only get more competitive.

Outcomes Case: One of the objectives of the pilot is to see if Cleveland Clinic can consistently improve the outcomes/health of its chronic care patients that will result in fewer hospital readmissions and/or complications. If all goes as planned, Cleveland Clinic believes that it will be able to use these positive results to request better reimbursement schedules (more income) from health plans. This certainly makes logical sense, but to date, health plans and CMS have been reluctant to support such programs – more of a wait and see approach. Hopefully, Cleveland Clinic will start showing some impressive results in a year or so and get those health plans on-board.

Final Note:

A couple of weeks ago I poked Microsoft about their lack of support for the telehealth consortium, the Continua Alliance. Sean Nolan responded stating a primary reason was Microsoft’s desire to move quickly (consortia always seem to move at a snail’s pace). Looks like that has paid-off as Google Health and Dossia cannot, today, support such capabilities as demonstrated above, though they are on the path having joined the Continua Alliance and Google demonstrated modest capabilities at the recent Connected for Health Symposium.

Looking ahead, we forecast 2009 to be a year of pilots which begin to demonstrate the utility of the platform model (Dossia, Google Health, & HealthVault) in support of telehealth and how telehealth technology and practices are best integrated into existing clinician workflow. Look to 2010 to see actual reimbursement models and P4P programs begin to take shape in support of promotion and adoption of telehealth.

Bosworth has kept a very low profile since leaving Google, but Matthew Holt was able to get an interview with him, which Matt posted today. Roughly 35 minutes long, it is a good interview to listen to if you have the time. If not, here are my take-aways, with some commentary in italics:

Despite Holt’s prodding, Bosworth gives tells little of what happened at Google that led to such a sudden departure. Bosworth claims that he decided he wanted to work in a small, entrepreneurial environment that was nimble without a lot of “processes”. This rings hollow as he worked at Microsoft and BEA prior to Google, both very big companies. I’m not sure what happened at Google, and not sure anyone will ever know the full story, but clearly, more happened than Bosworth is ready to divulge.

His new company, Keas, has 15 employees, is about 6 months old and is looking to provide consumers with the personalized information they need to better manage their health. Boy does that ever sound familiar and I could probably rattle off about 15 Health 2.0 type companies claiming to do the same thing. Bosworth will be at the upcoming Health 2.0 conference so maybe he’ll divulge more there. Right now, all I see (should I say heard) in this interview is a company with another me to product. Barriers to entry for such products are quite low, but risks are high. Just look at the Health 2.0 poster child Xoova, which appears to have gone up in flames. This whole Health 2.0 stampede takes me back to the glory dot com days when everyone was talking about how all procurement was going to move on-line and multipleon-line markets were created for various industres. There was a land-rush and the spectacular bust. We may be seeing the beginnings of something similar occurring now in the Health 2.0 market.

Bosworth sees a clear need for better consumer tools to manage their health, tools that leverage Personal Health Information (PHI). Surprisingly, he thinks there is enough digital data today (labs, medications & images) to provide significant value if it is leverage correctly. He praised the efforts of Google and Microsoft, particularly Microsoft, (hmm, that’s odd) for their efforts to collect this type of data into a consumer-controlled data repository. He also sees biometrics playing an increasing role as well. I believe this is where Keas will focus its attention – creating a solution that leverages PHI for structured search and presenting actionable information for the consumer to take preventative actions.

He sees the big adoption hurdle as not being the consumer, but the physician. Bosworth believes that a compelling motive for physician adoption and use of HIT has not been presented. Bosworth and I both agree that eVisits may be the silver bullet. Concurring with my recommendation to Sec. Leavitt in July, Bosworth stated that CMS can take a leadership role here by aggressively supporting eVisits, which may kick-start physician adoption. Gets back to the old, ‘Show me the money!”

Bosworth also commented on the privacy concerns surrounding a Google Health or Microsoft HealthVault. Some consumers will be comfortable with these offerings, others less so. He foresees more such platform plays entering the market to serve other segments of the market that do not want their PHI in a Google or Microsoft type entity, e.g., a non-profit. He also stated that for Google and Microsoft, a breach in privacy would be a disaster, thus they take extraordinary measures to insure that PHI is secure within their repositories. As I’ve stated before, I am in total agreement with his perspective on privacy as it pertains to Google and Microsoft. Do disagree on his belief that there will be a proliferation of platform plays. Simply makes no economic sense as these are expensive to build and pull a critical mass of data into, let alone establishing the multitude of partnerships to create a viable and vibrant ecosytem of Personal Health Applications (PHAs) layered on top of the platform. There will ultimately be 3, at most 4 platform plays, and that is being generous.