LinkedIn
Twitter
Blog

Blog

Mastering the Art of Healing the Most Complicated Patients: Spotlight on the Geriatrician

Recently, the New York Times published what feels like the millionth sobering article which called out the shortage of geriatricians in light of the great aging wave that is quickly barreling toward. We are consistently reminded that it is probably way easier to get tickets to a one-night only show featuring the Rolling Stones, than it probably is to see a geriatrician. With all this brouhaha, how much do we really know about this relatively rare specialty?

According to the American Geriatrics Society, a geriatrician is “a medical doctor who is specially trained to meet the unique healthcare needs of older adults. Illnesses, diseases and medications may affect older people differently than younger adults and older patients often have multiple health problems and take multiple medications.”  Truly, this definition does not do this specialty justice. In fact, geriatrics is probably one of the most complex areas in which to practice.

As we age, common conditions tend to present “atypically”, therefore practitioners must have incredibly astute assessment skills and instincts. For example, a patient with a urinary tract infection may not necessarily have burning, but might have a dehydration and confusion. Similarly, an MI might present mild discomfort in the upper abdomen rather than crushing chest pain. Therapy options are also limited to some extent; there are certain drugs that have a high risk to benefit ratio in the elderly. So too, they must play detective when a drug reaction or interaction is suspected.

Due to the nature of their patient population, geriatricians often veer well beyond the realms of what is considered “medicine”. They must take a holistic approach to disease management and prevention. It is not unusual that a potential crisis is averted by maintaining or improving function through the incorporation of nutrition, hydration, psychiatric modalities, physical therapy, and referrals to social work. We think of geriatricians playing a critical role in the identification and management of dementia. What is often neglected is that their training readies them to take on the challenge of treating other chronic conditions in the presence of dementia.

Talking about training, there is no shortage of fellowship programs with 104 in the U.S. alone. In the U.S., geriatrics is a subspecialty of internal medicine. A residency in internal medicine with a one to two year fellowship for geriatrics is required for certification.  In the EU, the training path differs by country with the norm being two to three years of geriatric concentration. Unlike in the U.S, 16 countries within the EU recognize geriatrics as a specialty.

To echo the Times article, there is a global shortage of geriatricians. Reasons range from funding and reimbursement to its perceived lack of “sexiness” by medical students and trainees. That said gaps are slowly being filled by non-physician clinicians such as nurse practitioners and physician assistants. Another trend is the geriatric focus of certain specialists. Behold the geriatric psychiatrist, geriatric cardiologist, geriatric nephrologist, geriatric oncologist and even the geriatric emergency physician. This is driven on the realization that many of the patients seen in these specialty practices are older or elderly and the appropriate knowledge base is critical to ensure optimal management. Other innovative solutions such as continuing education for non-geriatric clinicians are also well established.

With a solid grasp on the role and qualifications of geriatricians, industry professionals can develop innovative ways to engage and provide value to them. Additionally, there are endless opportunities to assist non-certified clinicians to practice geriatric medicine through effective therapy development and education along with linking clinicians up with valuable resources.

Melissa Hammond, MSN, GNP is Managing Director at Snowfish and a well-recognized industry expert in geriatrics. She can be contacted at Melissa.hammond@snowfish.net

Snowfish integrates, clinical, analytic, and business insights for life sciences companies. We have long experience of working on geriatric issues and have helped companies to realize the opportunities of therapies, products and programs targeted to the older population.  

Snowfish can be reached at (703) 759-6100 or via e-mail at info@snowfish.net.  We are also on the web at www.snowfish.net.

Posted by Melissa Hammond  |  0 Comment  |  in Management Consulting

Alzheimer’s – Science Sets Sail to Meet the Tsunami

AD Image

Departure of the Winged Ship by Vladimir Kush

The Grim Facts

It’s been called a coming “tsunami” with good reason. One in eight elder Americans have Alzheimer’s Disease (AD) and one in three elder Americans die with AD or another dementia. As baby boomers enter their golden years, the AD population is expected to nearly treble from 5.3 million in 2015 to 13.8 million by 2050, at an estimated cost of 1.1 trillion dollars and one in three of every Medicare dollar. Other developed nations face similar crises.

Government Responds

AD-SummaryMany national and state governments have recognized the tsunami threat and have put forward plans to address it. In 2011 President Obama signed the National Alzheimer’s Project Act (NAPA) with its number one goal to “Prevent and Effectively Treat Alzheimer’s Disease by 2025.” But behind the bold proposals actual government funding has been lack-luster. However, last month Congress passed a spending bill increasing Alzheimer’s research funding, effectively doubling the current $586 million to $1 Billion per year.

Presidential hopeful Hilary Clinton has proposed doubling funding again, calling for “rapidly” ramping up NIH spending on Alzheimer’s disease to $2 billion per year. While other leading presidential candidates have offered no such specific plans, they have been supportive: Bernie Sanders says he “believes very strongly” in more AD funding. Donald Trump, said that AD was a “total top priority for me”. In subcommittee hearings, Ted Cruz has strongly advocated more money be spent on AD Research. Marco Rubio said that a “Manhattan Project-style focus” is required on AD research.

With these greater gusts behind its sails can science now reach the NAPA goal and head off the tsunami?

The Science

To date there exists no effective cure for AD, nor any effective prevention. Worse still, there is scant understanding of the disease, its causes are unknown, as is its method of action on the brain. But there are clues for medical scientists to follow: from autopsies, for instance, it’s known that the brains of AD patients have distinctive plaques of the protein amyloid beta (Aβ), and also tangles of the protein tau.

Competing hypotheses for the cause of AD include: Mutations in various genes; reduced synthesis of the neurotransmitter acetylcholine; extracellular amyloid beta (Aβ) deposits; tau protein abnormalities; poor functioning of the blood brain barrier.

Here’s a glimpse at two of the most recent promising discoveries by AD researchers:

An Environmental Toxin

Back in the 1950s many native peoples of the island of Guam, the Chamorros, were dying of a paralytic disease with dementia symptoms. In post-mortems, US Army doctors noticed abnormal collections of proteins in the brains of sufferers similar to those of AD patients.

Fast-forward to the late 1990s when researchers led by Dr Paul Cox picked up the trail, visited Guam and found high levels of Beta-N-methylamino-L-alanine  (BMAA) in water pools and the seeds of the local cycad palm trees. BMAA  is an environmental toxin made by certain bacteria. The Chamorros use these seeds to make flour for tortillas and also cook fruit bats which eat the Cycad seeds and also showed high levels of BMAA.

And now Dr Cox and colleagues at the University of Miami’s Institute of Ethnomedicine have reported the results of an experiment on BMAA. Monkeys fed fruit laced with BMAA developed similar abnormal proteins (tangles) in the brain, proving the causal effect of BMAA. Further studies show BMAA mimics an amino acid called L-serine and inserts itself into brain proteins, causing them to misfold and tangle.

Currently clinical trials are testing whether giving patients L-serine tablets might prevent the misfolding effect.

The work was published in the January 2016 issue of the journal Proceedings of the Royal Society B

Brain Inflammation

AD Researchers at the Centre for Biological Science at the University of Southampton in England have recently found that “inflammation in the brain can in fact drive the development of the disease.” And that blocking a receptor in the brain that regulates immune cells could “protect against the memory and behavior changes seen in the progression of Alzheimer’s disease.

The researchers, lead by Diego Gomez-Nicola, first compared brain tissue samples from AD patients with those from healthy people of the same age. The Alzheimer’s samples were found to contain more of immune cells called microglia than healthy ones.

The research team then conducted a study on mice bred to develop the characteristics of Alzheimer’s. The mice were given a drug which blocks CSF1R, a receptor that regulates microglia. The treated mice were able to demonstrate “fewer memory and behavioral problems.” than the untreated mice.

The work was published in the January 2016 issue of the journal Brain.

The Future

Whether either of these two particular recent discoveries eventually lead to a method to prevent or treat AD is unknown. But with more and more funded AD research under sail there is reasonable hope that the effects of Alzheimer’s Tsunami can be at least reduced and a cure found within our lifetimes.

Snowfish integrates, clinical, analytic, and business insights for life sciences companies. We have long experience of working on geriatric issues, and particularly on AD and other dementias. We have built comprehensive databases and reports for clients on every aspect of the AD landscape, based on our own research and a wide variety of resources. Snowfish attends the major AD meetings including NAPA Advisory and NIH Alzheimer’s Summit meetings.

Snowfish can be reached at (703) 759-6100 or via e-mail at info@snowfish.net.  We are also on the web at www.snowfish.net.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Medical Affairs, Product Development

Singing Away the Pain: Brief Look at Music Therapists

Walk into any hospital and you might hear the strumming of guitars and harmonizing voices. This is most likely the music therapist. A growing number of hospitals, long term care facilities and out patient centers are utilizing these professionals to help patients more effectively deal with their illness and enhance the recovery process. According to the American Music Therapy Association, music therapy is the “clinical and evidence-based use of music interventions to accomplish individualized goals within a therapeutic relationship by a credentialed professional who has completed an approved music therapy program.”

Music therapists have at least a bachelor’s ideally from an accredited program. Through their music through passive or active means, they help patients reduce their stress, anxiety and discomfort in certain cases while increasing alertness and aiding in rehabilitating efforts in others. They are a common sight in children’s hospitals which tend to have full departments, but a growing number of organizations are using them. Music therapy is also used often for oncology patients and in management of dementia in long term care and the community setting.

A recent visit to the ICU showed that the role of the music therapist is not limited to patients who are awake and alert. Rather, he was strumming away and singing to an audience of heavily sedated and intubated patients. Interestingly, they are trained to observe the vital signs including heart rate, respirations and blood pressure, and adjust the tempo of the songs accordingly. I clearly observed the physiologic benefit in these patients.

More information on music therapy and its therapists can be found by contacting the American Music Therapy Association.

Posted by Melissa Hammond  |  0 Comment  |  in Management Consulting

Incorporating Non-Therapeutic Solutions into Commercialization Efforts

Happy New Ymandelbaumear!  As we are now three weeks into 2016, many of us have been dusting off our failed resolutions and hitting the gym. Eating more beans and green, trying to sleep more and manage that stress.

As little as a decade ago, we would have never thought of discussing lifestyle interventions with leading therapy companies. That has changed with the realization that prevention and management of disease requires a multi-faceted solution, not only a therapy. Chemicals and biologics form only a segment of the equation. A multitude of studies have cited the value of exercise, dietary modification and stress relief in conditions such as cardiovascular disease, diabetes, GI problems. Even patients with cancer and inflammatory-driven diseases can benefit from incorporating non-therapeutic solutions. Therefore, for industry to strengthen its offerings and provide more value to the market, it makes sense for the industry to take the initiative to build commercialization efforts that blend the non-therapeutic with the therapeutic. For example, we worked on a commercialization program that blended a lifestyle program (diet) and tools (blood pressure cuff) with a blood pressure lowering drug. The idea was to support the patient and clinician, and improve overall compliance and increase product satisfaction.

To be successfully incorporated into a disease management solution the evaluation and planning process needs to be of a similar level of scrutiny and rigor as the therapy they accompany. The same type of systematic analysis used for evaluating therapeutic agents should be the basis for a decision to incorporate a non-pharmacologic product or service. This approach is carried out in the following steps.

Establish overall goals for the solution.

This is essentially the most critical and the toughest part of the process. For a blended solution including lifestyle modification or any other non-therapeutic offering to work, it has to have a purpose besides just supporting the therapeutic agent. It should give the customer a reason for doing business with the company. Additionally, this is the time to be clear on how the intervention will be provided – is it a value-add, out of pocket offering, or even covered through insurance (lofty goals are just fine at this point). This is where a workshop-type of format is useful here as it allows all internal stakeholders to sort out their thoughts concerning this offering and to allow for prioritizing amongst the team.

Extensively search the literature to determine any evidence for the use of lifestyle changes in the prevention or management of the given condition.

Be clear on what the non-therapeutic intervention needs to be. This may appear intuitive when in fact it is not clear until after a lot of digging is done. This means a comprehensive literature review which should not be limited to the peer-reviewed articles but also rounded out with lay sources. A systematic approach utilizing specific search terms will help to (1) understand evidence for broad categories of non-therapeutic approaches and objectives and (2) begin to pinpoint the specific interventions which accomplish them. For example, increasing activity can be achieved through structured exercise programs, counseling, increasing daily activity measured through a fitness tracker, maintaining accountability for exercise using a digital app or even finding ways to leverage resources already available.  In the case of dietary modifications, there are many opportunities for synergistic effects of diet with therapy. Case in point is the recent focus on the microbiome and how it may impact multiple conditions ranging from obesity to inflammation. Could there be a particular dietary intervention that targets the ideal balance of the microbiome which can effectively augment a therapy and how could it be implemented?

Do a competitive assessment to understand the options, their benefits and challenges.

It is guaranteed that the first step in this process will yield an endless number of potentials which must be whittled down to something manageable. This is the time to do an in-depth analysis of the options and compare and contrast according to various factors such as cost, ease of use, available evidence, and how suitable it is to the particular disease state and companion therapy. This is also the ideal time to determine the unmet needs of the market and explore the use of existing products or services versus creating one from scratch. For example, according a recent article in Fortune, the weight loss industry in the US alone was $64 Billion in sales in 2014, however over one third of the population is considered obese and another third overweight. It is fruitless to offer the same programs that are currently failing the population. Additionally, while fitness apps and wearables are all the rage, surveys have shown that around 50% of us lose interest in them, thus rendering them valueless to a significant portion of the population.

Engage clinicians, patients, and other stakeholders, particularly payers.

As often non-therapeutic approaches clearly take more time and effort than prescribing a drug or inserting a device, it “takes a village” to make sure that they are as effective as possible. It is also critical that they meet an unmet need. The virtual trash is full of impractical initiatives and digital solutions that have quickly lost their luster due to their being too arduous or not to maintain. Such offerings are in fact, detrimental to the therapy and risk the adoption of the overall solution by the patient and clinician and potential reimbursement by a payer. For example, a world renowned expert in preventive medicine indicated that even though diet and exercise is the number one remedy for vascular inflammation it won’t work “because patients won’t do it”. He obviously had not been exposed to a solution that he feels provides value. Even if clinicians are on board, according to a 2014 article in the Washington Post, the majority would not know the first thing to tell a patient about diet or exercise.  On the other hand, payers are already offering multiple programs and apps which are designed to encourage increased activity, more healthful diet, stress reduction and psychological wellness. It is imperative to understand their hot buttons and how a particular non-therapeutic modality will serve their interests while augmenting their efforts.

The trend is undeniably moving toward an integrated approach to disease management and industry should be a leader with the evolution to solutions that combine therapy with other components such as behavioral modifications, services and digital applications rather than drug or device on its own. While the development time and investment is nothing close to what is necessary for an FDA-approved therapy, it is still imperative that only the most effective and synergistic lifestyle interventions are identified, developed and integrated as inability to do this will negatively impact the overall solution offering.  The idea is to support the patient, physician, and improve overall compliance and increase product satisfaction.  By producing better results an integrated program will ultimately build product differentiation in an often crowded market.

If you are contemplating a non-therapeutic component for your own therapy-based disease management solution, Snowfish is happy to help.  Our years of experience in commercial analytics have helped multiple companies to develop integrated disease management solutions which include non-pharmacologic/device components. Please reach out to us at www.snowfish.net or +1-703-759-6100.

Melissa Hammond, MSN, GNP is Managing Director at Snowfish a commercial insights firm.  

 

Posted by Melissa Hammond  |  0 Comment  |  in Management Consulting

Staking out Success in New Product Planning

Figures-around-the-tableNew therapies entering the market face a fiercely competitive landscape and companies continue to work committedly to establish and maintain their edge. One way has been to get the right individuals and groups on board for expert guidance and to build momentum. Stakeholder engagement has always played a role in the product planning phase but this has historically been limited to leading physicians and researchers who focused on the scientific or clinical aspects of the disease and treatment.

The constantly evolving healthcare landscape has realized that optimal prevention and management of disease requires a collaborated effort of interventions and disciplines. It truly “takes a village”. Then why during the critical stage of mapping a product for success should we exclude entire groups who are indeed so instrumental?

It is essential to understand not only who these stakeholders are and what they are about, but also their inter-relationships. Appreciating the synergies of these stakeholders and how they work together within a particular disease landscape can help define a strategy of how a product can best fit once it is launched. To achieve this most effectively, an approach should leverage analytics, clinical insights, and business acumen. The net result of this process is a deeper level of understanding that empowers all aspects of product planning including market assessment, forecasting, budgeting and influences critical go/no-go decisions at every step.

The process starts with assessing the stakeholder landscape. All stakeholders that have direct or even tangential influence are reviewed and analyzed. As can be seen below, clinicians only comprise small segment of the overall stakeholder landscape.

Government Public/Private Partnerships Patients
Non-Pharmacologic Approaches Professional Societies Payers
Diagnostics Clinicians Think Tanks
Hospital/Provider Groups Caregivers Corporate Initiatives
Advocacy Groups Competitors Celebrities

Now, doing this type of analysis requires more than a few sources. Rather a tremendous amount (I’m talking about 100+ sources) of information should be gathered and from “disparate” sources. We have found that often combining dissimilar datasets provides the most valuable insight. Additionally, there is no need to recreate the wheel, a lot of data exists both in the public domain and on many company’s servers. The secret ingredient to understanding stakeholder significance and interaction is not the data itself, but the ability to determine the types of data to include how to analyze it. Algorithms should be developed that incorporate an understanding of the entire disease state “ecosystem” including clinical, institutional, financial, advocacy, supportive, advocacy, and others.
Once a wealth of information is captured in a relational database, there is virtually an endless number of stakeholder analyses that can be conducted. Here are a few examples

Hospitals/Providers

For most conditions, hospitals and other institutional providers have proven to be important stakeholders. They may deliver care for a particular condition and be instrumental in providing or referring for a particular therapy. These institutions may conduct research related to the disease or therapy. They may treat patients fitting a particular profile. Even through the category of “hospitals/providers” are indeed important, there is only a subset that would be considered true stakeholders for a given disease. Put this into perspective given the fact that there are approximately 6,000 such institutions in the United States alone. Critical inputs should include factors related to expertise, and focus in the particular disease state as well as innovative care models.

Objective measures such as disease state specific clinical articles, trials, treatment staff, guidelines, affiliations, membership, etc. should be incorporated. In addition, subjective measures such as hospital survey rankings, KOLs, Medicare rankings, press releases, should also be used. The net result is a very select list of 10 to 25 disease state specific hospitals/providers to collaborate with on new product development.

Associations/Advocacy Groups

As with institutional providers, professional societies and advocacy groups are certainly critical to engage in the planning stage, but which ones are truly stakeholders for a given product? We find that often there are varying types and levels of collaboration opportunities offered by such organizations. The challenge is how to assess the opportunities that are best aligned with a product’s objectives. To bring this to life, I present an example of a company that was interested in building an integrated diabetes solution based upon multiple product and service offerings. They clearly recognized the importance of society and advocacy group collaboration. They also knew that time and resources were not infinite and that they needed to be selective in their partners. We were able to help them narrow down their possibilities by zeroing in on the most important areas to the company and determine which organizations were best aligned with as many of these areas as possible. As noted below, the focus was well beyond therapy alone.

  • Expanding screening/diagnosis
  • Proactive disease management/prevention
  • Development of innovative therapeutic solutions
  • Generating clinical evidence to best match therapies with patient needs/support reimbursement
  • Enhance health care provider skill/expertise in management
  • Community based public health programs/ patient and caregiver disease education
  • Achieving national quality standards

Other important factors included professional vs. consumer membership, industry relations personnel, and their willingness to collaborate with industry.

Through this detailed analysis leveraging multiple data sources, the company was able to identify the society/advocacy group partners upfront that presented the best opportunities for this diabetes solution from the perspective of setting direction and ongoing collaboration.

Stakeholder Interaction

By gathering a tremendous amount of independent data from diverse sources and links can be established between people, initiatives, products, competitors, across multiple stakeholder groups.

It is extremely common for a given individual expert or organization to be involved across multiple stakeholder groups. For example, an expert in their own right could also be at a particular institution, serve on a professional panel, and be on the board of an advocacy group. Similar insights can also be yielded for industry competitors. The table below illustrates the leading companies engaged in public-private partnerships around a specific disease state and the number of initiatives they were engaged in. In addition, we were also able to assess the spending, key clinical & research individuals, and messages across multiple stakeholder areas. Merck was engaged in four times the number of initiatives as BMS around the specific disease state area. Equally important, we were able to identify the companies not engaged in any activities.

Corporation # Initiatives
Merck 8
Eli Lilly 6
Pfizer 5
GE Healthcare 3
Janssen 3
Sanofi 3
Biogen Idec 3
Novartis 3
Bristol-Myers Squibb 2

Snowfish has developed this unique approach that leverages analytics, clinical insights, and business acumen to assess the various external stakeholder groups. The net result of this process is a deeper level of understanding that empowers product assessments, forecasting, and influences critical go/no-go product planning decisions at every step. Individuals and policies are able to be assessed across multiple groups and companies are able to plan their launch activities on a very detailed level. To learn more, please feel free to contact us at sales@snowfish.net.

David Fishman, MBA is President at Snowfish a strategic insights firm. Please go to snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Management Consulting, Medical Affairs, Product Development, Strategic Partnering

Combining Care with Cure: A New View on Palliative Care

Palliative CareQuality of death… No, that is not a misprint. It is actually the main premise of a recent report released by the Economist Intelligence Unit (EIU) which exposed the global disparities in the availability of palliative care relative to the estimated need.

While a key objective of shedding light on the value of palliative care particularly given the aging of society was met, the use of the term “death” indeed misrepresents the main intention of these types of services. In fact, it is quite common for many stakeholders within the medical industry including clinicians, patients and therapy manufacturers to equate palliative care with end-of-life care or hospice.

Rather, palliative care is a valuable complement to an actual treatment which ideally takes place throughout the course of disease management. According to the World Health Organization (WHO), palliative care is:

An approach that improves the quality of life of patients and their families facing               the problem associated with life-threatening illness, through the prevention and                 relief of suffering by means of early identification and impeccable assessment and             treatment of pain and other problems physical, psychosocial and spiritual.

In the context of palliative care “life threatening” should not mean imminent death, but refers to a condition that can ultimately result in a person’s demise. According to a 2013 report titled, Essential Medicines in Palliative Care, these interventions should:

  • Provides relief from pain and other distressing symptoms;
  • Intends neither to hasten or postpone death;
  • Will enhance quality of life, and may also positively influence the course of illness;
  • Is applicable early in the course of illness, in conjunction with other therapies that are intended to prolong life, such as chemotherapy or radiation therapy, and includes those investigations needed to better understand and manage distressing clinical complications

These points drive to the fact that end of life care or preparing for death are only a small fraction of palliative care. As echoed by Diane Meier, MD a primary-care geriatrician and director of the Hertzberg Palliative Care Institute at Mount Sinai School of Medicine in New York City, “The vast majority of patients who need palliative care are not dying”. She supports that all patients regardless of their ability to recover from serious illness should be receiving palliative care measures.

While not characterized as such, the therapeutics industry has been long engaging in
palliative care. These measures are designed to treat the often debilitating symptoms associated with an illness or its treatment such as pain, anxiety, depression, cachexia, nausea/vomiting, constipation, and dyspnea.

Among non-drug interventions, pharmaceutical management is an essential part of alleviating them and the industry is marketing and developing a multitude of therapies for this purpose. Despite all of the efforts in this area, companies fail to tout their palliative care portfolios.

The reason is likely due to points made earlier; the perception that palliative care equates to preparing an individual for death. As an industry, we revel in the thrill of the “cure”, “control” and “putting disease into remission”. There is likely poor awareness of the benefits of palliative care beyond relief of individual suffering even though a significant amount of evidence supports that palliative care in addition to conventional medical care results in improved quality of life, higher satisfaction with medical care, lower rates of readmission/emergency department visits, and even greater survival in certain diseases (cancer).

Is there benefit for the industry to formalize our role in palliative care?

Absolutely – though significant analysis is critical to determine how this should be defined. It can be as simple as pulling disparate agents into a single portfolio or creating a subset of within a given disease state portfolio to provide a coordinated method for “care and cure”. Products may be incorporated with other non-pharmaceutical methods and even certain types of training to offer a whole palliative care “service”.

Regardless of the nomenclature used by the EIU to discuss palliative care, the report is still
worth a read. It reinforces that the need for palliative care is growing. The aging of our society brings with it the increases in diseases such as cancer, arthritis, dementia and chronic obstructive pulmonary disease which will expand the need for primary care.

This is a ripe opportunity for the therapeutics industry to take hold of. The therapies are already being marketed and the relationships with stakeholders are in place. Through sharing of information and coordination, the therapeutics industry can take advantage of this significant opportunity – to move the focus away from quality of death with disease to living in comfort with disease.

 

Melissa Hammond, MSN, GNP is Managing Director at Snowfish at commercial insights firm. She is an expert in aging and aging issues as it relates to therapy development and commercialization. Please go to www.snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Management Consulting, Medical Affairs, Product Development, Strategic Partnering

Open Payments Wabi-Sabi

Cracked Face

Unlike the Western World’s cultural devotion to “perfect beauty”, in Japanese art and culture the aesthetic of “Wabi-Sabi” – beauty that is “imperfect, impermanent, and incomplete” is much admired. As beauty is in the eye of the beholder, perhaps Open Payments is thus a delight for Japanese data analysts!

Open Payments had a difficult birth – the initial release in September 2014 contained payments for just the last five months of 2013 and was maimed by problems correctly identifying recipient healthcare providers, leaving 2/3rds of the over $3 Billion in payments as “de-identified”, making the dataset pretty useless for solid analysis.

The second release of Open Payments, on June 30th 2015, corrected that very ugly flaw, for both the revised 2013 and new 2014 data, boasting that all the payments were now “matched with total confidence to a particular covered recipient”. But there are plenty of lessor flaws that can trip up the unwary analyst.

Uncommon Teaching Hospital Names, Chopped or Not

Payments to around 1,200 teaching hospitals are in the dataset. CMS chose to use Open payments2the “PECOS” name of the hospital that had been originally registered with Medicare. Unfortunately these names can be quite different from the well-known hospital names we know today. For instance, you may be looking for payments to the famous Memorial Sloan Kettering Cancer Center. But its PECOS name is Memorial Hospital for Cancer & Allied Diseases. And that’s the name you will have to search for in the 2013 data. But to make it harder still, for the 2014 data CMS decided to truncate the names down to 36 characters (and upper case them), so you need to change your search to “MEMORIAL HOSPITAL FOR CANCER AND ALL” to find Sloan Kettering in the 2014 data.

Unique IDs, With a Catch

But, you may reasonably argue, CMS keeps a unique ID for each teaching hospital, right? Argh, yes and no! In their infinite wisdom they decided to change all these “unique” IDs for the 2014 data, so Sloan Kettering has ID 102 in the 2013 data, but ID 1265 in the 2014 data!

Non-covered Entities Munch on the Research Dollars

For research, as well as payments to physicians and teaching hospitals, payments to other “Non-covered Entities” are collected. These are typically hospitals, including, strangely, teaching hospitals. The thing is these mysterious Non-covered entities, in pac-man-esque fashion, are munching the vast bulk of research dollars:Research Payment Recipients

But Where’s the Beauty?

Despite its pretty darn ugly flaws, Open Payments can produce very interesting results, if analyzed carefully to avoid the booby traps. Here are some of the types of valuable analysis that can be performed:

  • By drug: Identify the most highly paid physicians in certain activities for a target list of drugs, categorized into speaking, consulting, and research engagements.
  • By competitors: Analyze your competition – see how your competitors compare in their marketing budgets, and where and on whom they spend their money.
  • By KOLs: Analyze the work of your own KOLs, find who else is funding them, and how you stack up against them.
  • By Institutions: Discover which institutions are receiving major research funding in your areas of interest, and from which of your competitors.
  • By Partners: Find new partners for your business plan, and analyze current partners, by identifying companies making complementary products who are spending in your target areas.
  • Trend Analysis: Find trends in your area of interest – who are the rising stars, and which types of work is becoming more valuable, and for which drugs.

How Do I Do These Tricky Analyses?

Snowfish offers a white paper, Healthcare Big Data: CMS Open Payments, covering the Open Payments database and its possibilities in more detail, and also have a real example of an analysis in Excel. The example shows the 30 most highly paid psychiatrists and neurologists, where we calculate the total payments made to each physician in each of a number of categories, and show not just the companies making the payments but also the associated drugs for the payments.

If you are interested in learning more about Snowfish’s industry-leading approach to healthcare data discovery and mining, and how we can help with your custom Open Payments analyses, please feel free to reach out to us.  This is the time to capitalize on this fascinating new opportunity.

Martin Snowden is Director or Technology at Snowfish. He is an expert at database integration and analysis. Snowfish integrates, clinical, analytic, and business insights for life sciences companies. We have worked with nearly three dozen companies for over a decade and leveraging big data to help increase a company’s competitive advantage. Snowfish can be reached at (703) 759-6100 or via e-mail at info@snowfish.net. We are also on the web at www.snowfish.net.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Management Consulting, Medical Affairs, Product Development, Strategic Partnering

Beyond KOL Identification & Mapping, What’s Next?

For decades, we have regarded physician key opinion leaders (KOLs) as the “rock stars” of the life sciences industry. Like the musical ones, these leaders have influenced trends and packed rooms. The press would chase them to get a window into what they are thinking. I guess one key difference is that they tend not to destroy hotel rooms.

Similar to a star musician’s impact on a large record label, the life science industry has long depended upon these influencers who were predominantly physicians, to ensure a therapy’s success.

Enter social media and other drivers of product uptake. The music industry has witnessed songs being made available digitally via an immeasurable number of sources and thus easily shareable. The artists themselves are no longer the main promoters of their product as others (mainly fans) through their endless articles, blogs, Tweets and reviews carefully guide our tastes in music. Technology has also opened a path for lesser known independent artists to gain widespread exposure.

Comparable dynamics are observed in the world of medicine. The physician is no longer the sole gatekeeper to access to the product of medical care. We all know that payers can make or break a particular treatment through their level of willingness to cover it.

Other clinicians such as nurse practitioners and pharmacists have been stepping up for some time now, to provide care and counseling. Widespread availability of information has patients more informed than ever. They are sharing their knowledge electronically as well as banding together to advocate for greater access and policy changes. Societies representing patients and professionals sponsor guidelines and position statements to guide disease management. Additionally, there is the role of research consortiums, support groups, social activities, technological modalities (such as telemedicine), and even home care and government-provided services to consider.

Physician KOLs, while still important, must be regarded as a key entity of a larger ecosystem of critical stakeholders. As every disease state or therapeutic area has its clinical specialists, it also involves the cooperation of other groups that are essential to ensuring that a disease is well managed and treatment takes place. Snowfish has worked with clients to define the larger ecosystem. Our analysis has spanned a broad and diverse constituencies including:

Centers of Excellence Mid-Level Practitioners
Payers Celebrities
Competitors                                     Think Tanks
Patients                                              Government/Policymakers
Caregivers Private/Public Partnerships  
Societies                                              Diagnostic Providers

Physician KOL mapping is ubiquitous within the life science industry. This is clearly not enough. Utilizing sophisticated analytics while taking a creative and forward thinking approach to data sources will help to zone in on the most important stakeholders which will not only build momentum around a product but an entire offering.

While our industry still has our obvious “rock stars” and needs to continue to cultivate them, it is evident that there are others who are exerting their influence in less than obvious ways. Identifying and engaging them will best ensure that for any given company, the music will never stop.

Melissa Hammond, MSN, GNP is Managing Director at Snowfish, LLC, a commercial insights firm. Snowfish has expertise in analysis of non-physician stakeholders and KOLs. Snowfish offers stakeholder identification and profiling to help companies understand who to engage not only today but ten years out. 

Please go to www.snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Medical Affairs, Product Development, Strategic Partnering

Coca Cola and the Sunshine Act

Have a Coke and a smile. Drink Coke and teach the world to sing. Everything tastes better with Coke.

Those iconic jingles back in the 70’s and 80’s the Coca-Cola Corporation conveyed the life-enhancing benefits of Coke. In response, the world lapped it up like, well…soda.
Fast forward to the 2000’s and things are quite different. Finally catching up with common sense, science has realized that sugary drinks including sodas have been an integral contributor to our global obesity problem. Coke and other soft drinks are no longer something to feel good about but potentially hazardous to our health. In fact since 1998, sugar-sweetened soda consumption has been on a downward trend since 1998.

Ironically, despite the perceived health concerns associated with its product, a number of medical societies and institutions have been accepting millions of dollars in grant money from Coca-Cola. According to a recent New York Times article, the organizations such as the American Academy of Pediatrics, American College of Cardiology have been recipients. A list published on Vox Science and Health notes that funding has even gone to Brigham and Women’s and the Baylor College of Medicine. Much of this has gone toward research and educational programs focused on the value of physical activity.

Why is this relevant to the Sunshine Act?

A review of the Centers of Medicare and Medicaid Services (CMS) Open Payments website fails to find any mention of financial relationships with big food or drink companies. This is because the Sunshine Act a provision of the Affordable Care Act, this measure mandates that only financial relationships between the pharmaceutical/medical device industries and individual physicians and institutions are publically reported. The ultimate goal is to prevent the influence of these monetary exchanges on treatment decisions and help the public understand which physicians and institutions where there may be such potential.

Does it make sense for big food/drink to report relationships in Open Payments?

There is no clear evidence that funding from pharmaceutical or medical device companies will influence practice any more than that from other sources. Additionally, omission of companies like Coca-Cola from Open Payments fails to acknowledge the role that lifestyle choices play in disease management and the influence that physicians and premier medical institutions have on these decisions.

If the objective is to ensure that unbiased management decisions are made in the clinical setting, the limitation of CMS Open Payments to the pharmaceutical and medical device industries fails to appreciate the complete ecosystem involved in the prevention and management of disease. This is also evident in the decision to omit prescribers such as nurse practitioners, nurse midwives and physician assistants from the reporting mandates.

In face of the changes in attitude toward soft-drinks and other processed foods, Coca-Cola still appears to still want the world to sing in harmony. When health practitioners and researchers, it should be required that we know who the voices are.

Can I leverage Open Payments?

Open payments provides a wealth of competitive data that can be leveraged. The ability to categorize the competition’s spending by category and physicians is tremendous. The data can also be integrated into KOL identification and mapping projects. To learn more please contact the Snowfish team.

Melissa Hammond, MSN, GNP is Managing Director at Snowfish, LLC, a commercial insights firm. Snowfish offers a sophisticated analysis of Open Payments to help companies gain multiple insights on expert-industry relations. We can also augment this with other data not available in Open Payments for a more complete picture.
Please go to www.snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Melissa Hammond  |  0 Comment  |  in Management Consulting

Critical Insights into Alzheimer’s and Dementia

Imagine two 747 jetliners loaded with passengers crashing every day, that is the number of Americans that are dying due to Alzheimer’s and dementia. It is by far the greatest health crisis the country faces and the burden keeps increasing every year as the population ages.

Snowfish has been focused on multiple disease states associated with aging such as heart disease, cancer, and dementia including Alzheimer’s. We recently attend the Alzheimer’s Association International Conference (AAIC) with the goal of understanding the latest dementia developments and what the future holds.

Much of the excitement surrounded advances in the science (understanding the pathophysiology, identifying potential drug targets, determining genetic indicators, preclinical markers) and the search for a cure. Unfortunately the few drug trial results were quite underwhelming. Technology and new discoveries have grown the dementia community’s knowledge base by leaps and bound, yet a cure is still beyond our grasp.

Filling this gap was all of the other research featured at the conference that emphasized a variety of non-pharmacologic ways to care for those already with the disease and prevent it in individuals characterized as having “pre-dementia”. We’ve highlighted thought-provoking themes we picked up on either through the sessions or conversations with a number of the poster presenters.

Alzheimer’s Disease in the Oldest Old
When we think of the burden of Alzheimer’s disease we tend to forget that it is the oldest old who have the highest chance of developing it. Maria M. Corrada-Bravo, ScD, of UC Irvine co-lead investigator of the 90+ study also reminded us that this age group is the fastest growing demographic in the U.S. and it is predicted to make up almost 5% of all elderly by 2020. At this time, there is a lack of accurate data for cognition and function in the oldest old due to the complexity of their physiologic and psychosocial situations. For example, incomplete data resulting from study visits cut short significantly impacted cognitive scores. Creative trial design is important to ensure that accurate data for Alzheimer’s and other forms of dementia are captured in the oldest old in order to best service this important dementia population moving forward.

Behavioral Approaches to Dementia Management
An entire plenary was devoted to Alzheimer’s and dementia management. Behavioral health expert Laura Gitlin, PhD, from Johns Hopkins, highlighted a number of coordinated care models that empower professionals such as nurses and occupational therapists. The ability to leverage these disciplines is very important given the fact that there are not enough physicians to take on these functions. Dr. Gitlin noted that while studies of such care models are small, they have shown an effect on caregiver burden and nursing facility placement.

Similar approaches appear to be going on in various areas of the U.S. as well as globally. One example is a group at Wake Forest that is conducting a comprehensive counseling program for dementia patients and their caregivers. The director is both an MD and certified counselor. Another is the UCLA Alzheimer’s and Dementia Care program, which will provide comprehensive, coordinated care, as well as resources and support, to patients and their caregivers. It is led by a team of geriatricians and nurse practitioners. Beyond the initial interaction much of the follow-up is conducted remotely.

A challenge that we heard time and again related to patient access. For example, the UCLA program has a waiting list of around 200. Funded with grants, this model is not yet completely conducive to standard forms of reimbursement (i.e., Medicare).

Another challenge is geographic reach. When asked about the uptake of the Wake Forest counseling program, we heard “around 50% of patients enroll”. This is due to issues with patients/caregiver having to travel long distances to participate. At this time the program is not implemented too far beyond the Winston-Salem region. Telemedicine approaches, a potential solution for travel requirements, are not being utilized at this time.

The potential of an Alzheimer’s cure is not likely within the short-term. However, there are millions currently with the disease and those who will soon develop it that need support. Maintaining independence and quality of life through behavioral interventions and coordinated care should be a priority. There is opportunity to identify and map the multiple coordinated care pilots being conducted across the U.S. and determine the best practices within each of them. With this, such models can be replicated and more effective care implemented while research for new therapies continues.

Lifestyle Modifications to Prevent Conversion from Pre-Dementia to Dementia
A recurrent theme was the role of lifestyle modifications, those common in cardiovascular risk reduction, in the prevention and slowing of Alzheimer’s disease. Per Laura Fratiglioni of Stockholm University in Sweden, lifelong exposure to multiple factors may have a strong influence on one’s likelihood to develop Alzheimer’s disease. She outlined three strategies, which if implemented in middle age, could reduce the risk. These include:

  • Healthy lifestyle (moderate alcohol, physical activity, diet)
  • Decreasing vascular burden (treat hypertension, diabetes, heart disease)
  • Increase brain reserve (mentally complex activities, physical activity, social network)

A few points about a few of these risk prevention strategies. With respect to physical activity, it is not “exercise” but “movement” that has demonstrated benefit. One study reported that being more physically active over the course of the day results in lower risk of both MCI and Alzheimer’s disease.

She highlighted the FINGER study, which is the most robust trial of lifestyle intervention in Alzheimer’s disease prevention. It concluded that a multi-domain intervention can improve or maintain cognitive functioning in at-risk elderly people from the general population.

David Bennett, MD, of Rush Alzheimer’s Disease Center presented his perspective on the forms of psychosocial risk factors. He noted that increased social activity, “less constricted life space” (how far you go out beyond your room or home), lower levels of depressive symptoms and neuroticism along with increased conscientiousness and higher purpose in life correlate with a reduced risk of Alzheimer’s disease and MCI.

A conversation with members of the Alzheimer’s Research and Prevention Foundation reinforced these points as their mission is to expand knowledge regarding disease prevention through lifestyle modification – diet, activity, stress management and spiritual fitness. They showed us some results of studies that demonstrated a positive effect of yoga and meditation on measures of cognitive function, frontal lobe activity, and cerebral perfusion. Interestingly enough during our conversation, a young neurologist approached and cited her own study being conducted utilizing yoga in dementia.

There is growing interest in lifestyle modification for the prevention and management of Alzheimer’s disease. This is further demonstrated by the creation of dementia assessment and prevention clinics at Weill Cornell and University of Alabama Birmingham. Additionally, centers such as the Lou Ruvo Center on Brain Health (at the Cleveland Clinic) offers an on-line assessment and risk reduction plan through their website.

Many of the risk factors addressed are the same as those for cardiovascular disease and diabetes. There may be significant opportunity for the dementia community to collaborate with specialties like cardiology and diabetes educators (who have already laid down much of the groundwork) to create an integrated risk reduction plan that will also decrease Alzheimer’s disease along with these other important conditions. As surveys have noted, people tend to be more afraid of dementia than a heart attack, this could serve as a valuable motivator to engage not only in a plan which is multi-modal, but multi-effect.

Other Interesting Findings

  • An individual’s identity beyond the diagnosis of dementia is key to their well-being. This includes recognition by social relationship, family relationship, occupation, etc.
  • A physical therapist at University of Michigan in Flint has taken the lead to educate others in her field in how to screen patients for dementia when performing physical therapy. A survey she conducted of 542 physical therapists indicated that cognitive screening is not conducted routinely.
  • A discussion with a geriatrician noted that certain large dementia assessment centers may indeed have a waiting list of six months to a year. This is a significant problem if the medical community is to increase screening and identification.
  • One poster initiated a discussion on medical cannabis in patients with dementia. It cited results from a small study carried out in a nursing facility in Israel. Of 19 patients treated with medical cannabis, 17 achieved a healthy weight. Additionally, muscle spasms, stiffness, and pain were reduced. Medical cannabis has not yet been formally explored in the U.S. as a treatment for patients with dementia.

Conclusion
There is rising awareness on a global level of the importance of developing a systematic plan to identify, treat, and manage Alzheimer’s and dementia. For example, on January 4, 2011, President Barack Obama signed into law the National Alzheimer’s Project Act (NAPA), requiring the Secretary of the U.S. Department of Health and Human Services (HHS) to establish the National Alzheimer’s Project to:

  • Create and maintain an integrated national plan to overcome Alzheimer’s disease.
  • Coordinate Alzheimer’s disease research and services across all federal agencies.
  • Accelerate the development of treatments that would prevent, halt, or reverse the course of Alzheimer’s disease.
  • Improve early diagnosis and coordination of care and treatment of Alzheimer’s disease.
  • Decrease disparities in Alzheimer’s for ethnic and racial minority populations that are at higher risk for Alzheimer’s disease.
  • Coordinate with international bodies to fight Alzheimer’s globally.

The level of funding has been increasing as both citizens, industry, and government realize the need to develop better solutions. For FY 2015 the U.S. Government devoted more than $1.170 billion to research at the National Institutes of Health focused on geriatric research. We are still early in the game. Having worked in the field for over twenty years, I am finally starting to see progress. Hopefully, as awareness increases and resources are devoted to these devastating conditions, old age will not involve the loss of mental ability.

______________________________________________________

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.

Posted by Dave Fishman  |  Comments Off on Critical Insights into Alzheimer’s and Dementia  |  in Management Consulting