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As Companies Tackle “Age-Related Diseases”, How Much Do We Know About Geriatricians?

It is encouraging to hear the news of further investment  – $1B to be exact – into extending research collaboration between AbbVie and Calico focused on developing innovative therapies for “age-related diseases”. This partnership is evidence of the growing industry movement to embrace the differences across the lifespan and focus on therapies which can be tailored to this unique and medically complex population.

Such development initiatives underscore a very important stakeholder group  – geriatricians. While they are in high demand by patients, who are realizing their value,  their numbers are relatively meager as geriatrics does tend to have the appeal of other specialty tracks. Thus there is a low likelihood that an industry professional will come in contact with a geriatrician and it is often not clear what they bring to the table and how they differ from other clinicians such as internists and primary care.

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.

In reference to training, there is no shortage of fellowship programs with 139 in the U.S. alone. In the U.S., geriatrics is not even a specialty, but rather 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, 19 countries within the EU recognize geriatrics as a specialty.

As said before, geriatrics does not have the draw enjoyed by other specialties. 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 concentration with certain specialists. Witness the geriatric psychiatrist, geriatric cardiologist, geriatric nephrologist, geriatric oncologist and even the geriatric emergency physician. This is driven on the appreciation 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.

Given the steady focus in the development of therapies for age-related diseases, it is more imperative than ever to partner with this very important stakeholder group. With a solid grasp on the role and qualifications of geriatricians, industry professionals can develop innovative ways to involve 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 has pioneered this unique approach of building custom stakeholder landscapes designed to meet the needs of the particular product. Individuals and policies are able to be assessed across multiple groups and companies are able to plan their pre-launch and launch activities on a very detailed level. To learn more, please feel free to contact us at sales@snowfish.net

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, Medical Affairs, Product Development, Stakeholder Mapping

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.

The stakeholder universe is way more complicated than that. Unlike years past, we have finally come to the realization that physicians are not the be-all-end-all and that optimal disease prevention and management requires a collaborated effort of interventions and disciplines. It truly “takes a village”.

Further adding to the complexity is that that understanding these stakeholders and what they are about is not enough. We also need to know 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 clinical insights, analytics, and business acumen.

The process starts with assessing the stakeholder landscape. All stakeholders that have direct or even tangential influence are reviewed and analyzed. We tend to start by looking several degrees of separation from the “usual suspects” and then proceed to exclude those that are irrelevant. As 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.

Snowfish has pioneered this unique approach of building custom stakeholder landscapes designed to meet the needs of the particular product. Individuals and policies are able to be assessed across multiple groups and companies are able to plan their pre-launch and 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 consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. 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

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

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

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.
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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.

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