Since the Canadian and U.S. stimuli directed fuding towards electronic medical records (EMR), we’ve been following developments in the area as part of our Biotech Trends series here on the blog and have noted successes and failures.  A few recent stories highlight risks and benefits:

A recent Scientific American story (H/T @mikesgene) turned an analytical eye on the University of Pittsburgh Medical Center’s implementation, the current iteration of which started in 2004.  Case studies have been an important part of the EMR narrative, and many so far have focused on Kaiser Permanente’s implementation, which is the world’s largest civilian system, so it’s nice to see an in-depth analysis of a different experience.  The article closes with a quote from  National Institute of Standards and Technology (NIST) Director Patrick Gallagher, who says the stimulus effort

“is about using technology to bring health care information together to reduce medical error, reduce the need for testing, put information in front of patients, and put information in front of researchers.”

A FierceHealthIT story reported on an initiative by the American Telemedicine Association, which is running a demonstration program with DocTalker Family Medicine.  DocTalker, founded by Dr. Alan Dappen (partnered with @drval) is providing remote health services to Association members and employees.  It’s being pitched as an employee benefit that can promote worker health and productivity by reducing the need for office visits and providing round-the-clock responsiveness. 

Telemedicine’s role in EMR also features in this story about a pacemaker developed by St. Jude Medical that allows patients and doctors at the Montreal Heart Institute to get data and alerts from the device, which also transmits cumulative data to the doctors in advance of patients’ follow-up visits.

With all of these electronic data floating around, security is key, but it remains an elusive target.  Dan Vorhaus tweeted about a ModernHealthCare.com article that highlights numerous security breaches this Fall.  Microsoft’s purchase this week of Sentillion, which focuses on EMR security, was for an undisclosed sum but you can bet it’s key to Microsoft’s EMR strategy.

St. Jude Medical has recently won Food and Drug Administration (FDA) approval for a new pacemaker and a new Automatic Implantable Cardioverter Defibrillator (AICD). Both units are wireless! They also have already been approved for use in Europe.

Having your pacemaker or AICD checked usually happens every three months and is not difficult. I have a small box, about the size of a two large paperback books. I connect this box to a telephone line, then open the box and take out a small egg shaped device, connected to the box by a wire. Press a button on the box, then hold the egg against my abdomen just above my pacemaker. If I have it in the wrong place or I move it during the test, a small light comes on to let me know I am getting too far away from the pacemaker.

Once the box has read the pacemaker, it flashes another light and I push a button. While I am putting the egg back into the box and closing the lid, the unit automatically calls my monitoring service and relays the report. When it is finished I can disconnect from the telephone line and store it until next time. Total elapsed time: About ten minutes. It’s pretty simple.

But these new units feature wireless technology using St. Jude’s MERLIN system.  With MERLIN, doctors could monitor an implanted device several times a day without the patient even knowing it. Presumably, the patient sets up MERLIN in an unobtrusive place and goes on about his life. Whenever the patient comes within range of the monitoring device, MERLIN asks “How are you doing today?” – and reports the pacemaker/AICD’s answer to the proper monitoring service. That’s a third grade level explanation of how it works, but it will do.

The pacemaker check is already so simple that I write my next scheduled check on my calender and enter it in my computer to make sure I don’t miss it. This will make it even simpler.  People using the MERLIN system may very well forget that they have a little machine inside of their body that keeps their heart going!

And that’s the whole idea;

The Burnham Institute for Medical Research was in the national media spotlight with Nature Structural & Molecular Biology’s publication of a paper written by Robert Liddington, Ph.D.  The paper summarized the work of researchers with Burnham, Dana-Farber Cancer Institute and the Centers for Disease Control in identifying human monoclonal antibodies that neutralize a wide range of influenza viruses, including avian influenza A (H5N1). Russo Partners coordinated embargoed media outreach for Dr. Liddington that resulted in extensive print and broadcast coverage.

Cougar Biotechnology reported positive data from two Phase II trials of lead compound CB7630, abiraterone acetate, in patients with prostate cancer. Under the leadership of a former top biotech analyst, Alan Auerbach,this Los Angeles-based biopharmaceutical company is turning heads with its impressive data reports for a drug that has potential in multiple treatment settings. Russo Partners’ PR team has secured a radio interview for Alan Auerbach with Bruce Japsen, a Chicago Tribune healthcare business reporter who produces segments for satellite radio news program ReachMD.

Ambrx, a San Diego life sciences company, expanded its relationship with Merck Serono, a division of Merck KGaA, through a collaboration for the development of ARX424, a preclinical product candidate for the treatment of multiple sclerosis. This is the second collaboration between the two companies.  The first involves the development of a long-acting growth hormone that is in Phase II studies. Russo Partners’ PR program for Ambrx has helped to raise the profile of the company’s protein-optimization technology, ReCODE, among the pharma community.

Paris-based Fovea and Cambridge, Mass.-based Dyax entered into a development and commercialization agreement for the ocular formulation of DX-88 for the treatment of retinal diseases.  Fovea is one of the many European companies for which Russo Partners provides U.S. communications support.

Other February highlights included:

-Our coordination of media and investor meetings for multiple clients at the BIO CEO & Investor Conference in New York City

-The taping of an interview segment with Geron’s Tom Okarma and Nightly Business Report’s Susie Gharib for a special 30 Top Innovations episode    

-The handling of media relations for the third consecutive year at the Stem Cell Summit in New York City, where we set up CNBC for live broadcasts that featured interviews of CEOs with presenting companies

-Our coordination of a lengthy science/medicine story planning meeting with one of 60 Minutes’ senior producers

-Our participation in annual investor day events for two market-leading companies: St. Jude Medical and QIAGEN

-The welcoming of several new clients — Amira Pharmaceuticals, Calixa Therapeutics and Savara Pharmaceuticals – to our family of healthcare companies

Medtronic last week launched a new medical device in the U.S. to monitor heart beats and detect atrial fibrillation, or abnormal heart rhythms.  Called Reveal XT, it is a small device roughly the size of a memory stick, and is placed just under the skin in a brief outpatient procedure.  This is the most recent example of a fast moving and important

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.

January 2009 has come and gone. A wrap-up report of Russo Partners’ activities shows that biotech and medtech companies kicked off the year with a fast start.  Here are some of the January highlights:

S*BIO, Singapore’s most advanced biotech company, celebrated success on the business-development front with the announcement of two significant deals. The agreements, with Onyx Pharmaceuticals and Tragara Pharmaceuticals, involved different types of kinase inhibitors in early stages of development. Russo Partners worked closely with the communications teams at Onyx and Tragara to maximize publicity for the respective announcements. With the successful navigation of the media landscapes in the U.S. and Singapore, Russo Partners generated significant media coverage for all companies involved.  S*BIO’s executive team was inundated by calls and e-mails from other possible partners worldwide.

Anadys Pharmaceuticals’ stock price soared by 114% following the announcement of viral load reduction data from an early study of ANA598 in chronic Hepatitis C patients. By working with the data and select media under embargo prior to the distribution of a news release and the company’s hosting of a conference call with investors, Russo Partners lifted the curtain on the data in a big way. This PR approach produced a tremedous return in the form of in-depth media coverage that contained the key messages developed for the announcement. The PR results were far greater than any others of comparable Phase I trials.

Many of Russo Partners’ clients spent the second week of the month navigating the hotels and restaurants in San Francisco’s Union Square for JPMorgan Healthcare Conference activities. Russo Partners scheduled and coordinated close to 100 meetings for clients with VCs, investment bankers, fund managers and journalists. For new clients CorNova and Molecular Insight Pharmaceuticals, the conference was their first agency outing and involved high-powered meetings with members of the investment and media communities.

Other conference participants with Russo Partners included BIOCOM, San Diego’s life science industry organization, and the Burnham Institute for Medical Research. Media interviews conducted at the agency’s base camp in the Hotel Nikko along with TV interviews taped at a nearby studio added to the lively mix of activities.

Corthera, which is developing the hormone relaxin as a treatment for acute heart failure, took the podium at the JPMorgan Healthcare Conference and presented an update on the Phase II/III study.  In late-2008, Russo Partners unveiled an interim analysis of the Phase II data to journalists at the American Heart Association’s Scientific Sessions — a story that Cardiovascular Business reported as one of the most significant developments announced at the conference thanks to Russo Partners’ aggressive pursuit of media coverage.

Radi Medical Systems, which St. Jude Medical acquired in December, enjoyed broad media coverage of the New England Journal of Medicine’s publication of the FAME one-year follow-up data. See the January 20 blog entry to read more about this successful PR campaign.

In typical Russo Partners fashion, the agency continued its handling of the game-changing events in healthcare.  This time the event was the FDA’s clearance for Geron to initiate the world’s first clinical trial of a human embryonic stem cell therapy. Take a look at the January 28 blog entry.

Russo Partners looks forward to maintaining the fast PR pace in February with major client and industry events around the corner.