Massive New Payments Database has Treasure for Data Miners, with Caveats

Within the Patient Protection and Affordable Care (PPAC) Act of 2010 is a provision, known as a “Sunshine Law”. The law requires that healthcare manufacturers (pharmaceutical, biotechnology and medical device organizations) disclose payments they make to healthcare professionals and organizations as gifts, consulting fees, honoraria, travel, research grants and other means. The payment information is given to the Centers for Medicare and Medicaid Services, CMS, who then aggregate and publish the data, in a program called “Open Payments”. There were several delays in implementing the program, and in the meantime the organization ProPublica stepped in with a program called Dollars for Docs, aggregating data from a subset of 17 manufacturers who were already reporting payments.

Last month, however, the first Open Payments database from CMS has become publically available on their website.  While the main intent of the sunshine law is to inform the public of financial relationships between their healthcare providers and the manufacturers, the database also provides healthcare companies with both competitive intelligence and insights on key clinicians and institutions. Snowfish has analyzed the database and developed a white paper describing the database, its strengths and weaknesses, and ideas on how the data can be used by companies. Here we give highlights from our analysis, but for a deeper dive please contact Snowfish for your complimentary copy of this white paper.

What the database contains… and doesn’t

This initial release of the Open Payments database details payments totaling $3.5 Billion, for just the five month period between August 1 and December 31, 2013. The payments are made to a total of 546,000 healthcare providers and 1,360 hospitals, by 1,419 manufacturers and Group Purchasing Organizations (GPOs).

That all sounds impressive for a dataset until we find that despite the long delays in implementing the program,  only $1.3 Billion of the payments have been properly assigned by CMS to a named healthcare provider or hospital. For the remaining $2.2 Billion CMS has had to “de-identify” the payments, making them near useless for analysis. It is quite alarming that in four years of preparation CMS and its contractor, CGI Federal, did not have the foresight to insist that manufacturers provide unique, unambiguous identifiers for each payee. One such immediately obvious unique identifier would be the NPI number used in CMS’s own National Plan and Provider Enumeration System. Such a simple measure would have avoided much work in trying to identify the payees, and the embarrassment of having mainly failed in that attempt.

In addition, the database is missing another $1.1 Billion of payments, because either there was some dispute about the payment, or the manufacturer exercised their right under the law to delay publication of a payment for up to 4 years.

So in fact the identified data published represents only 28% of the total of $4.6 Billion in payments for the period. Still, there are certainly many interesting insights from evaluating the $1.3 Billion of properly identified payments. Thus, we may have hope that CMS will do far better with respect to payee identification in future releases of the database.

Structure of the database

The database is divided into three sections, based on the overall type of financial relationship:

• General Payments: Payments or other transfers of value not made in connection with a research agreement or research protocol.
• Research Payments: Payments or other transfers of value made in connection with a research agreement or research protocol.
• Physician Ownership Information: Information about physicians who have an ownership or investment interest in an applicable manufacturer or GPO.

The General Payments section contains identified payments from 948 companies. This ranges from a single payment to as high as 165,154 payments per company and from a total spend between just $13 and $130 million per company.

In the separate “Research” section we find 294 companies reporting payments for research, ranging from just $100 to $18 million.

How Snowfish helps industry use this new this data.

For well over a decade, Snowfish has been the business of identifying, mapping and profiling KOLs and Centers of Excellence, providing detailed analyses to scores of healthcare companies. We have incorporated payment information into our research ever since it first became available, including the ProPublica’s datasets. We have now adapted our proprietary software systems to incorporate the new CMS data, and are able to offer you this enhanced capability. Such financial data is extremely valuable to providing competitive intelligence, using purpose-built software tools and extensive experience.  

David Fishman is President of Snowfish, a leader in commercial analytics for life science companies with products in all stages of the life cycle. Snowfish specializes in driving innovation and challenging companies to look in new directions through a unique collaboration of strategic vision and sophisticated analytics overlaid with solid domain expertise.  He can be reached at dave.fishman@snowfish.net.  

The Global Aging Boom and Considerations for Therapy Development: Industry Progress Over the Past 20 Years

We are currently on the verge of the most pronounced growth in the geriatric population ever experienced.  By 2050, the United Nations estimates that the elderly population of the world (persons 65 and over) will double, from 7.6% to 16.2%.  The fastest increase will be of those 85 and older.  What is so critical to the healthcare industry is that with increasing age comes greater comorbidity and likelihood of an adverse drug reaction or interaction.  Aging impacts the pharmacokinetics and pharmacodynamics of many drugs by reducing hepatic metabolism (as low as 30-50%) and renal function while increasing the volume of distribution of lipid soluble drugs.  Consequently this extends a drug’s elimination half-life. 

Thus, there has been an ongoing call to action by experts in aging to the therapeutics industry to modify the way we do business, particularly in the area of drug therapy development.  In fact, as far back as 20 years ago, experts raised concern regarding the lack of consideration for the geriatric population during the planning and development of drug therapies, even those specifically targeted for use by older individuals.  A summary from a workshop piloted by the Institute of Medicine (IOM) focused on Drug Development for the Geriatric Population  published in 1990 expressed the need for significant changes in the effort to address this demographic shift.

As it has been 20 plus years since this document was written, I thought would be important to determine how much progress the industry and related stakeholders have made.  I have chosen to focus this post as well as the next on three of the key recommendations offered by this expert panel with an assessment of any developments that may have taken place.   The final three will be covered in a subsequent article.

1.    Design drugs specifically for older people.  The experts suggested that drugs destined for the geriatric population should be developed so that they ideally fit the needs of the aging body.  They would produce effects at a pace which maintains physiological balance. This would be slow enough to reduce shock to the system yet as quickly as possible to relieve symptoms at minimal doses. 

While such products do not yet appear to be available, there is evidence of  developments which if applied effectively could eventually accomplish this goal.  For example, personalized medicine such as intelligent dosing uses computer models.  It takes into consideration a multitude of factors to determine the ideal medication dose for a given patient.  In the area of drug delivery, innovations such as a multi-unit particulate system may allow drugs to be dosed in a highly precise and individualized manner by allowing a combination different pellets within a capsule or tablet to take effect at different times and at varying strengths. More appropriate drug formulation is also being examined; possibly greater availability of liquid formulations, rapidly dissolving tablets, and even drug-impregnated film that may be placed on the tongue.  Additionally, there has been interest among some researchers to address deficits in visual and tactile ability which result in difficulty of patients to differentiate one pill from the other.

While the number is still relatively low, companies have been taking interest in therapies for diseases of aging and those for frailty itself.  In particular, for a few years now, Sanofi has had the Aging Therapeutic Strategic Unit.  This department is charged with rethinking how treatments to the aging population should be developed and delivered.  According to an article discussing the Unit, there is concentration in detecting, preventing and reversal of age-related dysfunctions, disorders, and diseases including Alzheimer’s, chronic pain, osteoarthritis, hearing disorders, sarcopenia/frailty.  More recently, Abbvie and Google have paired up with the goal of spending up to $1.5 billion to research and commercialize novel drug treatments for diseases common in aging individuals.  This ranges from cancer to Alzheimer's disease.

2.    Increase training in geriatrics, pharmacology, and pharmacoepidemiology.  The report commented that in the late 1980’s there were few geriatric trained faculty in medical schools.  They blamed those circumstances on the lack of “drive to develop a geriatric research environment”.

As of 2013, there were 137 Liaison Committee on Medical Education (LCME)-accredited medical schools in the US.  The encouraging news is that the vast majority of schools offer in some form, geriatric education or training.  Still, the majority of the faculty who lead these programs do not have formal geriatric training; as of 2005, only 44% of directors of geriatric academic programs underwent either geriatric fellowship or earned a Certificate of Added Qualifications in geriatric medicine.  Furthermore, of schools awarding a degree of MD, in 2005 only seven reported having a full-fledged “department”.  Instead, they tend to be divisions or sections of other departments such as internal medicine.    As expressed in a 2009 article by Bernard, et al., a department provides for “a seat at the table” with respect to budgeting, strategic planning and allocation of resources within an academic institution.  Such status may indeed enhance research program development.   It should also be noted that as of this posting, unlike pediatrics, geriatrics is still considered a subspecialty. In contrast, in 16 countries within the EU, geriatrics is indeed a specialty; the differences between the US and the EU will be discussed in a future posting.

3.    Study very old – get results to physicians. The experts commented on the paucity of clinical trial data at the time in the very old and “oldest old”.  This includes patients over 75 and older and 85, respectively. Furthermore, this included the proposal to create a method of dissemination for such data to the wider group of clinicians who manage these patients.  This database would include the latest information on pharmacodynamics, pharmacokinetics, and interactions.

The number of older patients enrolled in clinical trials has somewhat increased since the IOM document, however there is still not adequate data available so that providers can be confident that the medications they use in their geriatric patients are safe and effective in this population.  For example, in a 2007 study sponsored by the Robert Wood Johnson Foundation which reviewed 109 clinical trials, it was revealed that a fifth of them excluded patients above a specified age, and that almost half of the remaining studies used criteria likely to exclude the elderly disproportionately—frailty or impaired cognition.

These results are echoed in a 2013 article by Hamaker and colleagues who reviewed 1207 clinical trials in hematological malignancies and found that  patient-centered outcome measures such as quality of life, health care utilization and functional capacity were only incorporated in a small number of trials. Even in trials developed exclusively for older patients, the primary focus lies on standard end points such as toxicity, efficacy and survival, while patient-centered outcome measures are included in less than one-fifth of studies.  In other words, the data from these studies are inadequate in their ability to provide effective guidance to clinicians on these therapies’ effect on the very old.  

In 1993, the FDA released guidelines focused on increasing the amount of geriatric information available in the label for drugs which will be predominantly used in this population.  By 1997, a “Geriatric Use” section was added to the label in order to report any pharmacokinetic or pharmacodynamic differences between the geriatric and overall populations.  Recently there has been a greater push by regulatory agencies both in the US and Europe with the release of ICH E7, guidelines driving toward the goal of ensuring that “real world” geriatric patients including “oldest old”, those with comorbidities, and receiving concomitant therapies are well-represented in  clinical trials of new therapies or formulations.  At current time, these remain only guidelines.  The FDA is currently holding meetings with experts on how to improve the data coming out of trials of therapies designed to treat diseases of aging.

The EU seems to be taking a more aggressive role as the EMA as part of the Agency’s Road Map to 2015, has devised a “Geriatric Medicines Strategy ” and has even put together a Geriatric Expert Group  that is charged with providing scientific advice to CHMP and the EMA on issues related to the elderly. 

The next post will outline and discuss key recommendations offered by the expert panel with respect to cost-containment, geriatric-specific endpoints, and with an assessment of any developments that may have taken place. In the meantime, I look forward to your thoughts.

Melissa Hammond, MSN, GNP is Managing Director at Snowfish and an expert in aging and aging issues as it relates to therapy development and commercialization.

Pharmaceutical Mergers and Acquisitions: Will they drive growth?

As someone who works in the pharmaceutical industry as well as an investor, I was curious as to the net result of all the mega mergers and acquisitions occurring within large pharma. Examples of such mergers and acquisitions could fill multiple blogs but I thought I would point out a brief history of a few industry leaders that were chosen at random.

In 2006, AstraZeneca acquired Cambridge Antibody Technology followed by the purchase of MedImmune in 2007. Sanofi-Aventis was formed in 2004 when Sanofi-Synthélabo acquired Aventis. Pfizer is now the amalgamation of Pfizer plus Warner–Lambert (2000), Pharmacia (2003), and Wyeth (2009). In 2009 Merck acquired Schering-Plough. In 2009 Roche fully acquired the remaining stake in Genentech. Clearly, mergers and acquisitions are occurring all the time and seemingly represent “usual” business as opposed to the exception.  Ever since, there has been a virtual explosion of M&A activity of various flavors and motives including large company acquiring small company, small company grabbing large company, merging for assets, acquiring for tax benefits. Various models are also being employed such as the J&J approach of maintaining the name and culture of the their procured businesses but under their umbrella and the recent example of Novartis who purchased not GSK in its entirety, but only their oncology business.

Regardless of their form, the question still remains: have mergers and acquisitions delivered more products and thus more shareholder value, for large pharma? Additionally, how should the value that is being created be assessed and from which viewpoint? Let me start with probably the easiest-long term benchmark to measure, the number of newly approved drugs by the FDA.

More Approved Drugs

Between 1996 and 2000, the FDA approved on average, 41 new molecular entities and biologic license applications per year. Over the next five years (2005 to 2010), the number was averaging 22 per year - a nearly 50 percent drop. Last year the number of new approvals did increase but it is far from clear that mergers and acquisitions are driving the development of more products in large pharma. One critic, in a 2012 article in Forbes Magazine, opined that just the opposite has in fact occurred; large mergers may indeed be stifling innovation.

Danzon et al. (2007) analyzed the effect of mergers in pharma/biotech on various measures of performance. He concluded that mergers result in slower growth and a reduction in operating profit. This was echoed by another study in which Ornaghi (2006) examined post-merger performance in the industry, but focused on productivity. Three years following a merger there is a decline in both R&D spending and productivity as measured by patents.

Based on the evidence, the argument that larger mergers and acquisitions result in more approved drugs or innovation is far from compelling.

Shareholder Value

Mergers are often promoted by very senior management as a way to increase shareholder value by reducing costs and duplication. In certain cases mergers are specifically designed to fill gaps in a product portfolio. However, irrespective of the merger’s objective, the net result should be increased shareholder value over the long term.

I was interested in evaluating how much the collective stock prices have changed for the big pharma companies given the mergers which have taken place, so I performed a retrospective analysis. Five large pharma companies were selected at random, AstraZeneca, Sanofi, Pfizer, Merck, and Roche, all of which had been involved in large mergers over the past decade and in certain cases multiple mergers. I chose the period from 4/21/06 to 4/23/12. While these are arbitrary dates they represent a period long enough where I would expect to see return given the mergers which had taken place. Furthermore, the period starts before the market crash in 2008 and includes the recent recovery. The results of my analysis are as follows. If I purchased one share from each company on 4/21/06 the combined value would have been $196.86. As of 4/23/12 the combined value of the same group of five stocks would be $188.46. So I would have essentially lost ($8.40) on my investment. There are dividends involved but the story is not really about stock appreciation.

The logical question to ask is how these five stocks compare to the broader industry over the same six year period. I looked at an electronically traded fund (ETF) with a symbol of XBI that represent 40 plus biotechnology stocks. Since XBI follows an equal-weight methodology, smaller component holdings have an equal say in the portfolio’s overall performance, compared to large-cap holdings. On 4/21/06 XBI was trading for $47.82. As of 4/23/12 the ETF basket of stocks was valued at $79.08. Had I invested in this EFT I would have made$31.26 per share or 65% as opposed to losing -4% with my basket of five large pharma stocks. Clearly, the five large cap merger stocks have underperformed a broad based ETF of over 40 companies over the same period. This leads me to question whether large mergers and acquisitions by large pharma regardless of the company, deliver stock appreciation. This is not meant to be a definitive inquiry but it does raise a basic question about the supposed value created by mega mergers in pharma.

Therefore, if it does not lead to more products or increased shareholder value, what is the value of these mega mergers?

Alliances a More Promising Alternative

One of most extensively published studies examining the performance of alliances was performed by Danzon et al. (2005). This report notes that products developed through an alliance tend to have a higher probability of success, at least for phases 2 and 3, and especially when the licensee is a large pharmaceutical firm. Another study, Arora et al. (2007) observed the role of licensing and alliances from 3000 R&D projects in pre-clinical and clinical trials in the United States. One of their chief findings is that licensing improves the probability of success.

In contrast to the results of studies focused on mergers and acquisitions, those investigating alliances found positive effects on R&D performance. They indicate that development experience is generally associated with higher success probabilities, especially in later R&D stages.

I leave it to the reader to consider whether alliances and product licensing are a more prudent task to take for large pharma. You can also learn about a process we have developed for identifying strategic partners by requesting our white paper. I welcome your thoughts.

David Fishman is President of Snowfish, a leader in commercial analytics for life science companies with products in all stages of the life cycle. Snowfish specializes in driving innovation and challenging companies to look in new directions through a unique collaboration of strategic vision and sophisticated analytics overlaid with solid domain expertise.  He can be reached at dave.fishman@snowfish.net. 

Need to See a Doctor? There’s an App for That

The other day I found an interesting “Groupon”-type offering in my inbox.  Along with the coupons for unlimited kick-boxing and the latest fusion restaurant there was a surprising offer for a service called Doctors on Demand.  This is a form of telemedicine which provides primary care/general medicine services while obviating the trip to the clinic. 

Telemedicine is certainly not new with its origins going back as far as the 1960’s when astronauts’ various physiological systems were monitored on the ground while they were on mission (recall the neurotic NASA doctor in the movie Apollo 13).  The technology and its indications have since evolved with it being employed in an array of circumstances where the expertise of a specialist is required but not readily available on-site – think ambulances (remote ECG interpretation) and evaluation of stroke.  It is also often used as a substitution for in-house resources as a cost-control endeavor.  As our firm Snowfish experienced through a recent project, remote radiology services can afford the opportunity to have images read around the clock without the need for in-house coverage. 

Whereas much of telemedicine has traditionally fallen within the realm of professional-to-professional, it has also been used to facilitate professional-to-patient interactions.  Using the telephone augmented with certain devices, heart failure has been monitored and pacemakers checked remotely.  Modes of video conferencing allow for post-surgical assessment and wound care.

Coming back to these newer services, one clear distinction is that they are more often patient-driven rather than initiated and organized on the professional side.  Essentially, a patient signs up for one of the services either as an ongoing subscription or fee for service.  When they have a need for a medical interaction (which ranges from acute events to monitoring chronic conditions) they will use a website or mobile app to put in a request for service.  This usually includes their reason for the visit, symptoms, etc.  The service should already have the patient’s demographics and medical history.

A medical professional (usually an MD but one site employs nurse practitioners as well) is supposed to get back to the patient within approximately 15 minutes via the choice of vehicle; phone or video conference.   What ensues is an exam which rivals an in-person clinic visit without the time and inconvenience associated with travel and dreaded waiting room.

In the words of Ron Burgundy of Anchorman fame, this is kind of a big deal.  Doctor on Demand is one of the latest services of this type.  For the last few years, multiple companies have started to provide virtual non-emergency clinic visits with private payers even jumping on the band wagon. Companies such as Cigna, United Healthcare, WellPoint, Aetna and Anthem are offering telehealth as an amenity to improve access and control costs.  With each passing year, the virtual clinic visit will become more commonplace.  Medical societies are realizing this with the American Academy of Family Physicians publishing policy regarding delivery of telehealth services.

At first glance, the therapeutics industry should consider five important factors related to telemedicine technology that can help continue effective business as usual along with new opportunities for value-added or non-therapy services.

1.   It is important to simply recognize medical care is going on in this alternative setting, and the clinician in fact may already be your customer.  These services employ a contracted panel of physicians who will take telehealth patients between appointments or at off hours.  It makes sense to learn who they are to better understand the true volume of the specific patient types or diseases they treat.

2.   Consider these encounters like “urgicare” or “minute clinic” type appointments, but even one further step removed.  It is extremely likely that the clinician taking the call does not know the patient and they are basing their information on the information history provided by them.

 

3.   Most often, patients turn to these services for non-acute issues such as rash, allergies, upper respiratory infection, and gastrointestinal upset.

4.   Review of the websites for these services note specific training on their websites in which each telehealth clinician undergoes, though the details were not clear.  Anyone familiar with patient assessment and care will know that remote examination requires unique skills.  There is the lack of two of the main senses – touch and smell.  The ability to listen is also diminished without the ability to use a stethoscope.   That said, the telehealth clinician needs to understand what can be handled via a virtual visit and what requires in-person attention.

5.   All telehealth service providers are allowed to prescribe medications barring Schedule I, II, III or IV narcotics or pain meds. 

Industry can use these new services as an opportunity to provide additional value to clinicians and patients as well as offer companion services utilizing this same technology.  Very adept at delivering education and training to the medical community, companies can offer courses which help beef up relevant assessment skills of telehealth clinicians so that they can better identify and diagnose the issue given the absence of touch and smell (particularly in the case of potential wound infection).  On the flip side, patient-directed efforts can aid in more effective communication of ailments and issues. Additionally, industry may harness similar technology to enhance adherence and manage a therapy’s benefit and side effects.

Lastly, though convenient, use of these telehealth services can impact continuity of care.  Strong communication between the telehealth clinicians and the patient’s primary provider is critical to ensuring adequate follow on care and monitoring. The services we reviewed tend to be EMR capable, however its utility is dependent upon the patient’s primary provider.   The fluidity of industry professionals amongst various clinical groups can help to facilitate that the communication channels remain clear.

So, between kick boxing and lunch at the fusion restaurant, I can get my sinus infection checked out but with some limitations.  Telemedicine is another small step for patient centeredness with giant implications for all.

Melissa Hammond, MSN, GNP is Managing Director at Snowfish, LLC, which specializes in commercial analytics for the pharmaceutical, biotechnology, and medical device industries. 

Has the “Gilligan’s Island Effect” Impacted You? What Can Be Done?

In the life sciences industry, pigeonholing or typecasting is very real among individuals and companies alike.  Job candidates cannot shake the perception of what they were in their old position.  Companies are only considered for the particular service or product they last provided, even if they have multiple core capabilities. 

I like to refer to this as the “Gilligan’s Island Effect” referring to the iconic 1960’s US-based show Gilligan’s Island.  For those who are unfamiliar or need a reminder, the show featured seven radically different individuals including the Skipper, his first mate (Gilligan), a movie star, farm girl, extremely wealthy couple, and professor went on a three hour tour and ended up on a deserted island.  Thereafter the entire premise revolved around the crazy antics of the group in their quest to return to civilization.  The show was wildly popular with the talent of the main actors driving its success with viewers.  Still, even though they were all accomplished thespians with talent to tackle various roles most were unable to disconnect themselves with their characters.  This resulted in extreme difficulty for the show’s actors to get other jobs following the show’s ending.  Blame it on re-runs, but in actuality, they were indeed typecast – unable to shake the perception of who they were in the show.

A company may have particular core competencies, be it strong science, innovation, analytic skills, or marketing.  However based upon a particular service or product provided to a customer or customer group the company may be perceived as having expertise limited to that specific entity.   For example, Snowfish has worked successfully with a number of companies to profile their KOLs.  The same expertise in creative analytics also has applicability to various other areas such as gap analysis, market assessment, publication analysis and planning, and competitive intelligence.  Since those specific clients were only exposed to our talents in KOL profiling we were essentially typecast in that role, making it difficult to sell our other comparable services to those companies.

Another case is the medical device company that has a product which competes in the pharmacotherapeutic or biologic space.  That is, it could serve as a device-based alternative to drug therapy. Prior technologies marketed by the company were used for indications for which surgery was the only option.  Thus, the company was viewed as only able to provide such types of therapeutic solutions.  The success of the new device necessitated targeting and engaging new customer segments not traditionally focused on by the company – non-surgeons/interventionalists.  Now, this company had many attributes which would make it well-respected by any physician: it has been producing therapeutic medical products for decades, has demonstrated strong science, conducts well-designed clinical trials, very few product recalls, and is a leader in innovation.  Still, non-surgical physicians have a hard time viewing a device as having the ability to treat a condition traditionally managed with drug therapy or the company having anything to offer them.  Like Bob Denver and the rest of the castaways from Gilligan’s Island, this company too is suffering from pigeonholing.  Their products are viewed as only valuable for surgeons and conditions that can only be dealt with surgically.

Once it is perceived, removing a professional stereotype is not an easy task.   Actually the ideal way is to avoid being typecast in the first place.  I have included a few tips below:

1. Position you or your company not for particular service or product but for a set of capabilities that can be translated to a number of areas and functions.  Define yourself by your capabilities as opposed to the specific area they have been applied.
2. People generally have little ability or desire to think abstractly, make sure you are able to provide concrete examples of how those capabilities will transfer to various disciplines and specialties. 
3. Don’t wait to branch out to other specialties or disciplines.  In the medical device company example, they should always be reaching out to non-surgeons even if they are not a main target.  Continually build your network.    
4. Upon launch of a particular product or initiation of service engagement, start looking at the next opportunity and identify/engage valuable champions in these other areas that you think you will need to target.   
5. Produce thought leadership pieces that demonstrate your core capabilities.

It is not clear if back in the 1960’s this would have helped the Gilligan’s Island cast, but it might be presumed that with a more proactive approach they could have escaped their on-screen personas once the series ended.  With the right amount of thought and positioning, you or your company can do the same. 

Dave Fishman is President of Snowfish, LLC, a strategic consulting firm which specializes in commercial analytics for the pharmaceutical, biotechnology and medical device industries.  Dave can be reached at info@snowfish.net.

Healthcare Big Data: Mining vs. Discovery

Sir Walter Raleigh’s military attempts to forcefully takeover gold mines in South America from the Spanish and to find new mines both ended in failure. When he turned his attention to the unexplored area of North America, that he named Virginia in honor of his virgin queen, Elizabeth I, he again failed to find new mines. He came back to the Queen instead with two plant life-forms unknown in the Old World: tobacco and potatoes. Although her majesty was not amused, the newly discovered plants were to have a far greater economic effect than Spain’s gold.

The typical procedures for handling “big data”, in healthcare as in other fields, are customarily referred to as “data mining”. The name is appropriate but self-confining. The healthcare industry now has an immense universe of data as its disposal, possibly more than any other industry. New data from pharmacies, insurance carriers, government, journals, hospitals, and data aggregators floods out from their data warehouses each month. And the data is complex compared to other industries too, with a typically large number fields for each record, and multiple identifying numbers for each entity. As McKinsey noted in its report (“The ‘big data’ revolution in healthcare”, Jan 2013), “…increases in data liquidity have brought the industry to the tipping point.”, concluding:  “Big-data initiatives have the potential to transform healthcare, as they have revolutionized other industries… Healthcare stakeholders that take the lead in investing in innovative data capabilities and promoting data transparency will not only gain a competitive advantage but will lead the industry to a new era.”

This type of data certainly contains plenty of nuggets of useful information to be mined, but it also contains a treasure of often unexpected information for those open to the concept of data discovery. Handling and analyzing such large and complex volumes of data requires sophisticated tools, carefully planning and skilled analysts. Thus projects undertaken to mine healthcare data tend to be expensive. A sophisticated database infrastructure, be it based on a traditional SQL DBMS or a newer technology such as NoSQL or  Hadoop, must first be implemented to contain the data, and specially trained data analysts must be engaged to process it. It seems very prudent then to set well-defined goals for such projects, with a limited scope. 

In practice these goals are quite varied, such as: identifying leaders in a particular field, finding particular trends in treatments, correlating multiple medical factors, and linking together individuals and organizations. But although such a sound standard business practice of setting tightly defined goals seems wise and logical, it means much insightful information can be missed - there is a wealth of useful information buried in all that mountain of data, and, and as the old adage goes, “We don’t know what we don’t know.” 

In a recent project we were asked to undertake such a project, with a well-defined set of goals of extracting information and links between a large number of key individuals. We accomplished the main goal, finding seventy-seven thousand healthcare providers closely linked to key practitioners. But, to the client’s delight, with our proprietary data discovery tools, we also discovered very interesting trends and correlations during the analysis, which were outside the project scope but inexpensive to accomplish once we started the data analysis. We discovered from the mountain of data not just the links to for key providers but also their affiliations to thousands of institutions. And interestingly it was also discovered that Nurse Practitioners were increasingly treating patients for a particular condition, while the traditional specialists were treating the condition less and less. Nurse practitioners had gone from prescribing 12% of the key drug to 14.5%, within just two years 

So to really make use of this expensive data an additional approach should also be considered – one of simple exploration and discovery. And given the costs involved, a good way to make efficient use of resources is have hybrid projects where there is a set of defined goals for what is be pulled from the data, together with an explorative component. Of course general guidelines must be given as to what types of new discoveries are interesting, and the tools and analyst team involved must be carefully chosen for their exploratory talents.

Snowfish can help optimize your approach to big data, using our purpose-built software tools and extensive experience.   We have worked with over two dozen life sciences companies for over a decade, discovering valuable insights from healthcare databases.  We have also developed services such as clinical data gap analysis, KOL identification and mapping, identifying strategic partners, and healthcare provider optimization, all based on analyzing and value-adding large healthcare databases. If you are interested in learning more about Snowfish’s industry-leading approach to healthcare data discovery and mining, please feel free to reach out to us.

Global Product Launch Considerations: Lessons Learned

Back in the 1990’s I admit to making a medical cultural blunder that has remained indelibly etched in my mind.  A patient of mine, a Chinese national was experiencing a high postoperative fever.  Like any well-trained American clinician I followed protocol.  I pulled off his blankets, made as many ice packs I could (OK, they were crushed ice in rubber gloves) and proceeded with my goal to make his bed equal to winter in Minneapolis.  To my surprise, his response was not relief but horror and sat up and threw all my hard work to the floor. Speaking no Chinese I could not understand his concern and was further perplexed when he started reaching for the hot tea brought earlier by his family.   It was only years later when I was researching cultural issues in medicine that I learned that hot blankets and hot tea are remedies for fever in traditional Chinese medicine (TCM). 

While this experience lasted but a short time and at incurred little to no obvious monetary cost, there was a blow to the trust between myself and my patient.  This could have been avoided by more knowledge on such cultural and geographical nuances.

Fast forward 20 years.  Our entire industry is interacting globally.  From selling and running trials to mobility of patients across borders, such understanding of local and cultural mores, practices and issues is critical for conducting business on multiple fronts.   That said there are various matters that require careful consideration.  Most often the focus is on reimbursement and overall health system issues.  Akin to my own experience with the patient described above, many of these go much deeper to the institution and individual clinician level.  For the past 10+ years, Snowfish has worked globally with multinational and local companies and have paid special attention to the micro-issues.  When they are addressed most effectually, this is how companies can make a real difference. Our experience has identified a number of information tidbits which have proven to be crucial to the success of global healthcare business.

Learning: Don’t assume a product used in one country is equally compatible in another. 

A major German company with a device used to deliver intraoperative radiation to treat breast cancer launched in the U.S. with surprisingly low penetration despite a very successful European launch.  The company was clearly interested in understanding the root cause.  With thorough analysis and comparison of the two markets, Snowfish found that this failure was related to differences in physician responsibilities, patient flow, as well as systems in place for intraoperative tumor biopsy and pathology services. 

First off, in Germany radiation oncologists were found to get involved much earlier in the treatment planning process, i.e., before surgery.  Therefore, the radiation oncologists were far more instrumental in the use of this technology and the adoption.  Alternatively, patients managed for breast cancer in the U.S. are less likely to see a radiation oncologist until after surgery.  Therefore most of the decisions about which treatment device falls upon the surgeon, who is not focused on the radiation component of treatment.  Even if the surgeon is supportive of the particular type of radiation therapy, multiple logistical issues posed by many U.S. hospitals added additional changes that impeded adoption including the time to receive the initial pathology report and the overall patient flow.   Clearly, three major components were different, physician targets, pathology process, and operating room flow.  The cumulative impact slowed adoption of an innovative product.  Had the company fully analyzed upfront the various country anomalies the U.S. adoption could have been smoother.

Learning:  Medical specialties do not always translate across geographies.

For particular therapeutic area knowing the target specialties to focus upon is not always the same across countries.  One example is the specialty of angiology.  Referred to as “vascular medicine” in the U.S, angiologists play a critical role in the treatment of various vascular diseases in a number of countries including the UK and the Netherlands.  Adding to the complexity is for conditions such as hypertension where in the U.S., clinical cardiology and nephrology take the lead, angiologists are integral in the diagnosis and management.   Furthermore, unlike the other specialties mentioned, angiology will also perform catheter-based interventions.  Even within the European Union (EU) the role of the angiologist will vary significantly, so much for the EU being one integrated market.  If key specialties such as these are missed, serious gaps with respect to clinical trial evidence, product specifications, targeting and KOL engagements will occur.

Learning:  Geographic clinician challenges are often unrelated to disease or reimbursement and need to be understood

A recent project brought us full circle, back to China.  Health care reform measures and entry of many into the middle class have resulted in an explosion of patients into China’s healthcare system.  With this has come new-found stress for an already over-stretched clinician workforce.  Couple that with growing violence against them by patients and you have a situation that is unsustainable for the long term. Recent reports have highlighted attacks against physicians and other health care workers by patients who claim wrongdoing.  While it is not clear if these patients are just misinformed or have unrealistic expectations the results are ultimately devastating to China’s healthcare system and their patient’s well-being. 

There is no simple solution to the situation given other related challenges such as variability in medical education, role of government, the disparity between urban and rural environments/services and prominent role of TCM. Nevertheless, such information regarding the state of the clinician can be very useful to better ensure more effective engagement and clinical value delivery.

Conclusion

Snowfish has worked on multiple products developed at the world-wide level.  It is very important to take into consideration the various factors in the planning stages that could affect adoption.  We have pointed out critical factors such as varying physician treatment responsibilities, product design, hospital processes, and cultural issues.  A company cannot be complacent and simply focus upon regulatory, reimbursement and distribution and expect a successful product launch.  A company needs to fully understanding and assess a country’s micro-environment.  To borrow a phrase from a former Speaker of the U.S. House of Representatives, Tip O’Neill, “all politics is local” I might add so are successful world-wide product introductions.