Category Archives: Health

Seizing Hope – An Anthropologist’s Perspective on a Movie Screening

Last night, I attended a screening of ‘Seizing Hope – High Tech Journeys in Pediatric Epilepsy’ at the Peter Gilgan Centre of Research and Learning at the Hospital for Sick Children in Toronto.

The evening was remarkable through the presence of a girl with epilepsy and her mother. I noticed them right away when I came into the auditorium and saw the girl in her wheelchair. I thought “Ah, a patient” and walked on.

Being an anthropologist by training and a market researcher for Canadian pharmaceutical companies and someone who does not spend much time in academic settings any more, two things struck me as remarkable in the set-up of this event:

Everyone was wearing a mask – “of course, we’re at a hospital” I thought.

Everyone in the auditorium had a microphone on their desk and the house lights were on the audience, whereas none of the panelists upfront had a microphone and no lights were illuminating them. I wondered whether this was a glitch in setup or reflective of the medical professionals’ attitude – “it’s not about me, it’s about the patient”.

The movie ‘Seizing Hope – High Tech Journeys in Pediatric Epilepsy’ which follows four families in their journeys leading up to and after getting a neurostimulator device implanted in their child’s brain, was both informative and touching. The most touching moment for me was when one of the mothers describes how her then four-year old daughter first got epilepsy. She lost the ability to walk, talk, deteriorated back to baby status and no longer recognized her as her mom. Any parent can feel the heartbreak that that entails.

I had seen an epileptic seizure before, but I did not realize the profound impact that the disease has on those affected, including families. This thoughtfully and gently composed movie is highly effective at communicating this. In addition to introducing new technologies that have the potential to help people with drug-resistant epilepsy, it really brings home the dire need for treatment and the equally important need to support families in their support of the patient.

However, real life is an even more effective teacher than any movie can be.

As the mother in the audience who had been in the movie was invited to the front to be part of the panel discussion, it was clear than her daughter also wanted her place in the spotlight (which wasn’t actually turned on, as mentioned before…). She walked up to the moderator and said hi, …and continued to make comments to her mom, the doctors she knew, her family members in the audience, and did not want to sit back down and listen. While the movie had talked about the impact on families, watching the family try to enable the panel discussion to move forward drew me and the other audience members right up close and into the experience.

But that was not all.

Towards the end of the event, when the girl had actually sat back down with her grandmother, she had a seizure. Her family, including her younger brother, immediately sprang into action, assisting her and dealing with the situation like the experienced support team that they are.

While most of the audience members turned to watch the event, I directed my gaze towards the pediatric nurse, neurologists, and neurosurgeons at the front. Clearly, they were torn between their assigned roles as panelists to wait and continue the discussion and their instinct as healthcare professionals to jump in and help. Several got up and sat back down again, struggling with the decision. A couple called out ‘Are you ok?’ to the family. Finally, one, the moderator, walked over and assured himself that the family was ok and able to cope on their own with what was occurring.

This cluster of family members around the girl in peril – their expert handling of the situation, from the oldest to the youngest person – this brought home more than anything to me how epilepsy affects lives.

Takeaways:

  • Doctors wear many hats. They are first and foremost caregivers, focused on making patients feel better and keeping them safe. They are also scientists, exploring new frontiers of medicine. And finally, they are advocates. It became clear in the panel discussion that access to new medicines and new technologies can be a huge issue and doctors play a role in advocating to governments and sometimes even to the manufacturers of these medicines and devices to make them available in Canada.
  • A film about patient experience is a powerful tool for education and advocacy. The four families whose lives were shown in the film had requested that it would strike a balance between authoritative voices and compassionate portrayal, and it did. It was informative about the new technologies and the ethical dilemmas inherent in them, as well as successful at showing the profound impact of the disease and at fostering empathy for those affected by it.
  • First-hand experience is even more powerful than a movie. Watching the girl interact with her doctors and nurse, observing their responses, seeing the concern in their eyes when the seizure happened and witnessing the family’s rush to help was something that a lay person like myself is unlikely to forget.  

Why was I at that event? Just a desire to see something new, after a long pandemic-induced hiatus. I have done some market research in neurology in the past, and would like to engage more with companies in the field, so I thought it would be a good idea to get some more exposure to an area within neuroscience.

What did I learn that could benefit my clients? Patient voices can be powerful advocates for bringing new medicines and technologies to Canadians, but physician voices also play an important role.

Alzheimer’s disease – not cracking the nut (yet)

As an anthropologist, market researcher and consultant working with pharmaceutical companies, I follow trends in the medical field. Neuroscience is one of the areas on the rise. Expecting this field to accelerate in terms of drug development, I compiled a comprehensive database of Canadian neurologists and started engaging this audience. Alzheimer’s disease specifically is an area of great unmet need where a massive market is ripe for innovations, pharmacological and otherwise. I recently surveyed neurologists to better understand their perspectives. You can read the results here: https://creativeresearchdesigns.com/examples-of-work

Neuroscience has received significant investment in the past decade.

In the U.S., President Obama launched the Brain Initiative in 2013 with a $100 million US dollar investment. He said: “Today, our scientists are mapping the human brain to unlock the answers to Alzheimer’s… Now is not the time to gut these job-creating investments in science and innovation. Now is the time to reach a level of research and development not seen since the height of the Space Race.”1

A similar investment was made in Canada with the establishment of the Brain Research Fund in 2011, a public-private partnership between Brain Canada and Health Canada. Its website describes the purpose of the investment as follows: “This visionary commitment by the federal government will ensure that Canada continues to be among the leaders in the global challenge to understand brain function and brain diseases.”2 Regional and local initiatives abound.3

However, while research funding is available, many worthwhile initiatives are competing for it.

Brain science is a diverse field; and neurologists often specialize in a particular area.

When I researched Canadian neurologists and potential participants for my Alzheimer’s survey, I noticed that only a subset of neurologists deals with Alzheimer’s and other dementias. Other significant specializations include multiple sclerosis, epilepsy, neuromuscular disorders, movement disorders (incl. Parkinson’s), migraine/ headache and stroke. The patient populations affected by these conditions are quite diverse, with epilepsy, MS, and migraine often affecting younger individuals and dementia, Parkinson’s and stroke primarily being diseases of the elderly.

While there are currently just over a thousand neurologists in Canada,4 only a subset of these would be relevant to a pharmaceutical company marketing a specific neurology drug.   

Many pharmaceutical companies have ventured into the area of neuroscience. According to the website Statistica, the top selling neurological drug products (2016 in the U.S.) are multiple sclerosis treatments, followed by medications for schizophrenia and bipolar disorder.5 Disease onset is typically younger for these conditions, impairment of day-to-day functioning can be significant, and patients remain on treatment for decades. Thus, they present interesting opportunities for pharmaceutical development.

Alzheimer’s disease is overdue for breakthrough discoveries.

But neurological diseases of the elderly have also received significant attention. Alzheimer’s disease, in particular, has proven to be a hard nut to crack. The last new treatment (Ebixa/memantine) came to Canada in 2005, joining the three cholinesterase inhibitors Aricept (donepezil), Exelon (rivastigmine) and Reminyl (galantamine). Neither of these agents are particularly effective in slowing down the progression of the disease. 

Many companies have tried to tackle the challenge of Alzheimer’s disease. Up until now, the path to a brighter future has been littered with unsuccessful clinical trials.6 Just this year, another five major flops joined the long list of previous attempts: Roche/AC Immune’s anti-tau antibody semorinemab, AbbVie/Voyager Therapeutics’ gene therapies, Sanofi/Denali’s RIPK1 inhibitor DNL747, and Eli Lilly’s and Roche’s amyloid antibodies solanezumab and gantenerumab. Biogen’s monoclonal antibody aducanumab is still in the running, but it faces an uphill battle to secure approval.

Will large pharma turn away, and leave the field to small, pre-clinical research companies for the time being? I believe there is reason for optimism about the future of brain research and the development of Alzheimer’s drugs specifically. Public attention and government incentives will continue to stimulate research. According to a recent article, 121 agents were in clinical trials for the treatment of Alzheimer’s disease at the beginning of 2020 (in ClinicalTrials.gov).7 Some are sponsored by large pharma and some by small start-ups. Even if beta-amyloid and tau protein turn out to be less promising drug targets than previously thought, with continued investment in this field, scientists are bound to come up with something eventually.

Non-pharmacological interventions deserve attention in Alzheimer’s.

In my survey among Canadian neurologists, one of the results that I found most interesting was their recognition of the importance of non-pharmacological measures.

Unprompted, Canadian neurologists identified supporting families, caregivers and home care as one of the top investment priorities to improve the lives of people with Alzheimer’s. When presented with a list of possible investment priorities, neurologists again picked ‘improved funding for home care’ along with ‘research into new drug treatments’ as the top two. Increased funding for long-term care facilities was perceived as less important.

Staying at home is certainly preferrable to living in long-term care, particularly under the current circumstances of the pandemic, and specific non-pharmacological interventions have the potential to significantly increase quality of life for Alzheimer’s patients.

One finding that intrigues and delights me is the brain’s storage of musical memories and the effect of music on the brain. It has been shown that memories of music persist while names of loved ones may already be fading into the background. The stimulation of those memories, and the participation in the making of music, can fill those affected by Alzheimer’s with great joy.

One of the projects supported by the Alzheimer’s Society of Canada is Voices in Motion, an intergenerational choir that brings together people with Alzheimer’s disease, caregivers and high school students.8 It combines the joyful act of singing with physical movement and social interaction. Based on findings from this study, researcher Dr. Debra Sheets, Associate Professor in the School of Nursing in Victoria, BC, will create a toolkit of best practices that can be used by other organizations who are interested in starting a community choir for people with dementia.

Early detection and screening are important, and AI may have a role to play in it.

For Alzheimer’s disease as well as for other areas of health, accurate and early diagnosis plays an important role in halting or slowing the disease before its effects become devastating. In fact, when my survey asked about top investment priorities, neurologists mentioned early detection and prevention unprompted. While there has been considerable research into biomarkers and brain imaging technology, more recently a number of companies have tried to harness the power of artificial intelligence for early detection of Alzheimer’s disease.

The Toronto startup Winterlight Labs uses AI to analyze speech patterns to detect cognitive impairment and other brain disorders.9 The company built a tablet-based assessment tool that is already being used in a clinical trial for an Alzheimer’s drug. Tech industry giant IBM, in conjunction with Pfizer, is working on something similar that presumably can predict onset of Alzheimer’s with 71% accuracy.10 Researchers at the Boston School of Medicine have developed a computer algorithm based on AI that can accurately predict the risk for and diagnose Alzheimer’s disease using a combination of MRI, testing to measure cognitive impairment, and data on age and gender.11

In Conclusion

Brain health is responsive to a variety of behavioural, technological and pharmacological interventions. Hopefully, research investments in Alzheimer’s will pay off in the not-so-distant future, and lead to breakthroughs that significantly improve the trajectory of this disease and the quality of life of those affected. I am keeping my fingers crossed.

1: https://obamawhitehouse.archives.gov/BRAIN; https://obamawhitehouse.archives.gov/the-press-office/2013/04/02/fact-sheet-brain-initiative

2: https://braincanada.ca/canada-brain-research-fund/

3: https://blog.braininstitute.ca/mental-health-is-brain-health-a-paradigm-shift/; http://www.camh.ca/en/driving-change/about-camh; https://www.uhn.ca/KNC; https://www.baycrest.org/; https://blog.mtl.org/en/montreal-leads-way-neuroscience-breakthroughs; https://www.mcgill.ca/neuro/

4: https://www.cma.ca/sites/default/files/pdf/Physician%20Data/01-physicians-by-specialty-province-e.pdf

5: https://www.statista.com/statistics/318259/revenue-of-top-20-neurology-products-in-the-us/

6: List of recently failed clinical trials in Alzheimer’s disease

Roche/AC Immune: https://www.fiercebiotech.com/biotech/roche-ac-immune-s-tau-blocking-drug-flops-alzheimer-s-as-biotech-s-shares-halved

AbbVie/Voyager Therapeutics: https://www.fiercebiotech.com/biotech/abbvie-cans-voyager-alzheimer-s-parkinson-s-gene-therapy-pacts

Sanofi/Denali: https://www.biospace.com/article/denali-and-sanofi-pause-alzheimer-s-trial-and-pivot-to-another-drug/

Eli Lilly and Roche: https://www.fiercebiotech.com/biotech/lilly-and-roche-s-antibodies-fail-late-phase-alzheimer-s-test

7: https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.12050

8: http://alzheimersocietyblog.ca/meet-researchers-debra-sheets-university-of-victoria/

9: https://winterlightlabs.com/

10: https://venturebeat.com/2020/10/22/ibm-and-pfizer-claim-ai-can-predict-alzheimers-onset-with-71-accuracy/

11: https://neurosciencenews.com/ai-alzheimers-16326/

Ensuring equitable access to healthcare in the age of algorithms and AI

Yesterday, Dr. Peter Vaughan, chair of the board of directors of Canada Health Infoway, spoke at Longwoods’ Breakfast with the Chiefs.

After outlining the current state and future perspectives of digitization in healthcare, his main message was two-fold: 1. We are at risk of a “failure of imagination”, i.e. we cannot fathom all the possible futures that digital disruption might confront us with and hence fail to plan for their pitfalls adequately. 2. There is great potential for algorithms to be built in such a way as to solidify and deepen inequalities that currently exist in our system, and we need government oversight of such algorithms to prevent this from happening.

The first point is easy to understand, the second point may need little more explanation. Algorithms are used widely to determine what information is presented to us online, what choices are offered to us. We are all familiar with websites, offering us items we ‘might also like’, based on our past choices and based on what other purchasers have bought.

At a time when data from various sources can be linked to create sophisticated profiles of people, it would be easy for a healthcare organization to identify individuals that are potentially ‘high cost’ and to deny them service or to restrict access to services. Bias can creep into algorithms quickly. If people of a certain age, ethnic background or location are deemed to be ‘higher risk’ for some health issues or for unhealthy behaviours, and this is built into an algorithm that prioritizes ‘lower risk’ customers, then you are discriminated against if you share the same profile, no matter how you actually behave.

Discrimination is often systemic, unless a conscious effort is made to break the cycle of disadvantaged circumstances leading to failure to thrive leading to lower opportunity in the future. As Dr. Peter Vaughan pointed out, we in Canada value equitable access to healthcare, education and other public goods. We expect our government to put safeguards in place against discrimination based on background and circumstances. But how can this be done?

Private, for-profit enterprises have a right to segment their customers and offer different services to different tiers, based on their profitability or ‘life-time customer value’. Companies do this all the time, it is good business practice. But what about a private digital health service that accepts people with low risk profiles into their patient roster, but is unavailable to others, whose profile suggests they may need a lot of services down the line? Is this acceptable?

And if the government were to monitor and regulate algorithms related to the provision of public goods (such as healthcare) who has the right credentials to tackle this issue? People would be needed who understand data science – how algorithms are constructed and how AI feeds into them – and social sciences – to identify the assumptions underpinning the algorithms – and ethics. Since technology is moving very fast, we should have started training such people yesterday.

And how could algorithms be tested? Should this be part of some sort of an approval process? Can testing be done by individuals, relying on their expertise and judgement? Or could there be a more controlled way of assessing algorithms for their potential to disadvantage certain members of society? Or a potential for automation of this process?

I am thinking there may be an opportunity here to develop a standardized set of testing tools that algorithms could be subjected to. For example, one could create profiles that represent different groups in society and test-run them as fake applicants for this or that service.

Also, algorithms change all the time, so one would perhaps need to have a process of re-certification in place to ensure continued compliance with the rules.

And then, there would be the temptation for companies to game the system. So, if a standardized set of test cases were developed to test algorithms for social acceptability, companies may develop code to identify and ‘appease’ these test cases but continue discriminating against real applicants.

In any case, this could be an interesting and important new field for social scientists to go into. However, one must be willing to combines the ‘soft’ social sciences with ‘hard’ stats and IT skills and find the right learning venues to develop these skills.

Much food for thought. Thank you, Dr. Peter Vaughan!

Medical marijuana in Canada

I attended a very interesting Life Sciences Ontario (LSO) breakfast meeting on medical marijuana in Canada. Here are some key takeaways:

Production

  • Currently there are only 38 licensed producers (LPs) in Canada that grow the plant.
  • Regulators control access to this market tightly and barriers for new companies to become licensed producers are high.
  • One of the challenges for production is to grow a standardized crop, i.e. plants that have roughly the same level of chemical compounds in them crop after crop.
  • Canada is perceived as one of the top players worldwide for growing of marijuana under controlled conditions that will stand up to health regulators’ scrutiny (along with Israel).

Distribution

  • Dispensaries are illegal – there is no legal grey zone. It is not Health Canada’s job to monitor dispensaries. This is the responsibility of municipalities. There seem to be crack downs on dispensaries occasionally, but then they spring up again.
  • The only legal way to obtain medical marijuana in Canada is through licensed producers, and they will ship the product to the patient directly.
  • There is currently a push to make other forms of distribution legal. At the forefront of this is Shoppers Drug Mart’s effort to convince regulators to let them dispense the product at their pharmacies. So far, no luck.

Acceptance in physician practice and among patients

  • Clinical studies on the benefits of medical marijuana are challenging since it is difficult to grow a stable product that will have the same properties throughout the course of the trial. Getting clinical studies published in peer-reviewed journals is also challenging. However, audience members felt that Canada is in an advantageous position in terms of conducting more research in this area.
  • The Canadian Medical Association does not condone widespread prescribing of medical marijuana, but it also does not actively deter physicians.
  • One of the challenges for physicians in prescribing medical marijuana is the fact that the product comes in a variety of forms and may not be stable/standardized. Many are uncomfortable prescribing the dry form, since it is unclear how exactly to dose it for a given patient. Prescribing the oil may be easier for physicians.
  • Patients may also have different preferences for an oil vs an inhaled product or even an edible.

Taxation

  • Experience in the U.S. has shown that the market will be impacted by decisions on taxation. If, for example, medical marijuana is taxed heavily and the recreational use of the product is taxed more lightly, patients will tend not to bother getting a prescription.

Regulatory

  • The regulatory process is moving slowly, slowly. While a regulatory framework has recently been proposed, making it into law could take 18 months or longer. According to meeting participants, the proposed framework will likely undergo many changes, and a final decision is not expected before 2019.

The LSO breakfast meeting took place on January 19, 2017 at the offices of Fasken Martineau in Toronto. The meeting was chaired by LSO Board member Dr. Alison Symington. The panelists were:

Ken Clement, CEO of ABcann Medicinals Inc, a licensed producer of medical marijuana. ABcann’s business is focused on growing organic standardized medical cannabis, recognizing that an expertise in growing standardized crops positions the company well in the medical marijuana market.

Christelle Gedeon, Associate at Fasken Martineau DuMoulin, is one of the firm’s regulatory affairs specialists with expertise in pharmaceuticals, medical devices, natural health products and medical marijuana, among other things.

Nick Antoniadis, Principal at Nick Antoniadis Consulting, is owner of his Toronto-based management consulting company. He is a marketing leader with over 20-years-experience in global healthcare. In the medical marijuana market, he has focused on connecting with and gaining insights from patient aggregators such as prescribing physicians.

Summary prepared by Barbara McGrath, PhD, Owner of Creative Research Designs, a company that provides customer insight and market research to companies in healthcare. This summary was not reviewed by LSO or any of the meeting participants. It reflects my own understanding of what was being said. You can contact me at: barbara@creativeresearchdesigns.com

cannabis

How pharma may or may not win in a digital world

Healthcare is going digital at a rapid pace. A recent article by McKinsey & Company titled ‘How pharma can win in a digital world’ outlines emerging trends in digital health and how pharma needs to evolve to keep up with the times.

A number of predictions in this article are, I believe, misguided and reflect a common, but incorrect understanding of the potential of digital in health.

Digital health collage 2

Prediction # 1: “Patients are becoming more than just passive recipients of therapies”

Patients have certainly become more knowledgeable about their own health and about available therapies. And hopefully, health-related apps are helping people lead a healthier lifestyle and stay on top of their medical conditions and medications. However, patients have never been passive recipients of therapies. Patients have always had the choice of taking or not taking their pill, cutting it in half, skipping a dose, forgetting to take it, taking it with food when they are not supposed to etc.

Having served pharmaceutical clients for more than a decade, I have frequently observed that it is difficult for someone within the industry to understand that the medicine they are producing is not the be-all and end-all of a patient’s existence. Life is a busy thing. You work, you look after your family, you eat, you entertain yourself, and you may have a health problem that benefits from taking a medication. The act of taking a pill consumes a fraction of your time and attention. Medicines for health issues that are non-symptomatic may be forgotten because the patient does not feel sick. Medicines for chronic, life-threatening conditions may have suboptimal compliance because the patient would rather not be constantly reminded about his or her precarious situation. For acute conditions, compliance wanes as soon as the patient feels better. Side effects deter patients from taking their pill, etc. Compliance would not be such a huge unsolved problem for pharma if patients were ‘passive recipients of therapies’.

Prediction # 2: “Patients will be actively designing the therapeutic and treatment approaches for themselves with their physicians”

I have read this type of statement numerous times in articles about the future of pharma. Perhaps I am lacking understanding of what’s technologically possible nowadays, but for now let’s assume I have a pretty good handle on it. Designing a pharmaceutical product is an extremely specialized and complex process that involves scientists and labs. A chemical or biological compound with certain properties is created to address a specific health issue, and this compound cannot be easily customized. Rather, it is created and then subjected to rigorous testing, costing hundreds of thousands of dollars (or more), and if it does not hold up to scrutiny, then it’s back to the lab for more experiments and tweaking before another round of expensive testing resumes.

Physicians who spend most of their time in clinical practice do not design therapeutic and treatment approaches. They are merely the retailers of those approaches, acting as consultants to their patients and advising them which approach may be best suited for them. And patients will not be actively designing their own therapies unless they are experimenting with mixing pills and brewing up concoctions of their own invention (caution: don’t try this at home, kids!).

With substantially increased access to information patients can play a much more active role in selecting treatments, but they will not design them.

alchemist-300px

Prediction # 3: “Medicine will be personalized to address individual patients’ needs” (not in McKinsey article, but can be found in many other publications on digital health).

The move towards personalized medicine is certainly well underway. However, it does not mean that a therapy will be designed on the spot for the individual sitting in front of his or her physician. Again, the physician is the expert mechanic using existing wrenches and bolts to fix the car. The inventor who comes up with new wrenches and bolts does not deal directly with the customer whose car broke down.

Tools

Personalized medicines are medicines that target issues more precisely than was previously possible. While physicians used to set off a grenade to blast away your breast cancer, and half of your body as well, they now use a precision rifle that locks in on the malignant area and eliminates not much else. And depending on your genetic profile, there are different bullets that are most effective for your particular type of problem. So the array and precision of weaponry in the physician’s arsenal has increased vastly, and affordable genetic tests have contributed to better targeting of the weapons. But none of these things are designed on the spot, while you’re sitting in the examining room, nor will this be possible for a long, long time.

Explanation: Poor understanding of digital vs. physical contributes to common misperceptions

How do these misconceptions come about and why do smart people write these things?

The past five to ten years of our experience of living in a digital world have greatly impacted our beliefs in how easily things can get done and our feeling of agency. Want to customize your new car? Just click on the features that you want – sunroof, heated seats and the colour red – and you can get this exact model without any effort on your part. Select the perfect outfit? Choose the style, colour and size, and get it delivered to your doorstep the next day. Don’t like part of your video? Just delete and replace.

The ease of these digital experiences has gotten us into the mindset that things can be designed instantaneously, delivered rapidly and modified on the spot. We rarely think about the physical realities that enable our digital experiences. To give you the experience of ‘designing’ the perfect outfit for yourself, the maker has to come up with new styles to attract your desire, run efficient manufacturing to put the piece together with acceptable quality and at an affordable price, ensure the supply chain to enable the manufacturing, build in agility to adapt supply to demand quickly, and create a distribution system to bring the piece to you. All of these things are not done through click of a button, but through the hard work of setting up systems, negotiating agreements, fine-tuning machinery and materials and implementing physical processes.

It’s the same for pharmaceutical products. They are chemical compounds, after all.

Digital opportunities

However, the potential of digital solutions to transform the way we care for ourselves and the way healthcare is provided to us is undisputed. From life tracker apps that help you remember to take your pills on time to smart contact lenses that monitor blood glucose levels without pricking your finger to ingestible sensors that give you peace of mind that your schizophrenic brother has actually taken his medication, digital interfaces, algorithms and sensors can deliver great value to the patient.

The question is how this translates into business opportunities. Many people believe that pharmaceutical companies should transform themselves from being “a products-and-pills company to a solutions company” (see McKinsey & Company article). The idea is to not only provide medicine to the patient but also digital tools for monitoring of the patient’s condition, for communicating with the patient’s circle of care, for scheduling and reminders, for supporting rehabilitation after events and for outcomes tracking. From a patient perspective, this could certainly be a valuable offering. From a business perspective, the value proposition is less clear.

First of all, pharma companies do not typically have the expertise to develop digital solutions in house. Some form alliances with tech companies. Novartis and Google are developing smart contact lenses for people with diabetes and are scheduled to start trials this year. Otsuka and Proteus Digital Health have teamed up to embed a digital sensor into a schizophrenia medication to track compliance, and have submitted the first digitally enhanced new drug application to the FDA. J&J has set up a series of incubators and rewards startups for coming up with interesting ideas in digital health. Merck sponsors health hackathons.

What does the pharmaceutical company get out of this? Will physicians choose their medication over competitive products because it comes with a digital value add? Is the digital component just another cost factor that is necessary to stay competitive these days, or is there a revenue model somewhere? It seems that there is currently a climate of experimentation without a clear business model path ahead, not unlike many other areas of digital development.

In crowded markets with little product differentiation, it is possible that the companion app could become the deciding factor in recommending one drug over the other. However, it is hard to imagine that it would play any role if there were differences in efficacy or side effect profile between the compounds. A tricky little question is also what to do with patients who need to switch off one product and go to another. Should they be denied continued usage of the app?

To be truly solutions providers, pharma companies would need to be structured differently, around disease states, not around products. It would make more sense to form a company that is, say, a ‘cardiology broker’, offered great digital tools to manage a variety of cardiologic conditions and give patients access to the full gamut of cardiology drugs available. The sales reps for this company would not overtly or covertly ‘push’ one or two drugs, but they would advise physicians on what is new in the field and impartially discuss the merits of the different options. There are some attempts of pharma companies to become leaders in a therapeutic space and assume the role of expert provider – for example Roche or Novartis in oncology, where both companies have a large product portfolio. However, by and large, this type of business model does not apply to how pharma companies are organized and how they make money currently. It would be more applicable to private payors, and we see some organizations in the U.S. moving in this direction.

Low-hanging but sour fruit

The obvious area where digital tools can be used very effectively to drive engagement is patient-related. Arguably, a more engaged patient will likely be more compliant and stay on therapy longer, resulting in immediate benefit to the bottom line.

However, while many companies try to be patient-centric, any direct engagement with a patient carries the risk of an adverse event report with it. While adverse event reporting systems have been set up to keep patients from harm, unfortunately, reporting requirements are ridiculously broad. Nobody is keen on generating massive amounts of adverse event reports for their drugs. So digital engagement of patients has to be done with all sorts of caveats to reduce the risk of learning about an adverse event. Some companies stay away from direct engagement with patients altogether for that reason; others have taken the plunge and struggle to come up with creative ways around the problem.

Another challenge in engaging with patients through digital tools and platforms is finding appropriate engagement formats for particular audiences. A platform that has been designed to help kids with pain through gamified challenges and ‘levels’ may not be the right approach to engage a 70-year old cancer patient. Very little testing and research has been done to date to find out what tools best support patients with certain conditions. The key here is to be open to a multi-platform approach. While a game may be great at motivating one audience, a combination of text reminders and phone support may be best suited to keep another audience adherent to their treatment. Unfortunately, many of the vendors that design patient engagement tools on behalf of pharma are either all digital or not digital at all. What would be needed is a new type of vendor who can pull together various types of tools and customize them for a particular target patient population.

Low-hanging sweet, sweet fruit

One area where pharma could employ digital innovation easily and with sustained impact is in the way companies communicate with physicians. While almost everyone has switched to iPads for detailing over the past few years, pharma companies (in Canada, my home turf) still have limited understanding of how digital can be used to improve access and deliver value to physicians. Knowledge about different forms of digital engagement is lacking in marketing departments where people think Twitter and Instagram are for self-absorbed teenagers with too much time on their hands. Also, there is a feeling that digital is not important to the physicians who are core to the business. However, as one year after another go by and younger physicians become key opinion leaders and high prescribers, companies may find that they have missed the boat in establishing a digital rapport with these individuals.

Only recently have some companies started to think about conducting media audits and finding out from their core target how they use digital tools and what might be of value to them. Putting some effort and resources into understanding the myriad of different ways digital can be used, and physician preferences in this regard is relatively simple and will almost certainly have a payoff within a five-year timeframe. There will likely be some resistance from the sales folks who tend to see alternatives to face-to-face engagements as a threat to their position. However, I believe that the 21st century sales rep needs to be an expert in offline and online relationship building. Pharmaceutical companies need to figure out how to integrate different forms of digital and non-digital engagement optimally, and create internal structures and tools to maximize value for the customer.

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McKinsey & Company article source:

http://www.mckinsey.com/insights/pharmaceuticals_and_medical_products/how_pharma_can_win_in_a_digital_world

Image sources:

‘Digital health collage’: Made the image myself

‘The alchemist’: https://openclipart.org/detail/222415/alchemist

‘Tools’: DeWalt DEWALT DWMT72163 118PC MECHANICS TOOL SET on http://toolguyd.com/dewalt-ratchets-sockets-mechanics-tool-sets/

‘Cartoon’: I’ve seen this cartoon on the web many times, but don’t know who made it originally. I’ve copied it from https://effectivesoftwaredesign.files.wordpress.com/2015/12/wheel.png?w=640

 

Wearable Tech and Health – not quite there yet?

Wearable tech is revolutionizing healthcare delivery – at least that’s what the pundits have been predicting for a number of years. The array of devices that are under development or already commercially available is stunning.

Looking only at devices that are used by patients on a day-to-day basis, there are three different areas of usage for wearable tech:

  1. Continuous monitoring of chronic illnesses

Many patients with chronic illnesses need to monitor certain biophysical parameters that indicate how well they are doing, if their medications are working and when an exacerbation of their condition would warrant visiting a healthcare professional.

Wearable devices that can sense and accurately measure heart rhythm, breathing rate, or blood glucose levels enable continuous tracking of critical markers and can help alert patients and their healthcare providers early to any arising problems.

  1. Improving the lives of people with disabilities

This is an area in which assistive devices have had a long history (think: hearing aids, wheel chairs, etc.). Digital sensor technology is now making devices more accurate, more personalized and more helpful.

Some examples of new technology that improves daily living include:

  • eSight Eyewear: A device consisting of a high-end camera, video processing software and processing unit and highest quality video OLED screens which project a real-time image that allow legally blind people to see.
  • Sensimat Systems: A series of pressure sensors that are placed under a wheel chair cushion. The sensors use a proprietary algorithm to monitor the seating pattern of the wheel chair user, and send a notification via smart phone when it is time to change position to minimize the risk of pressure sores.
  • TAPS Wearable: Velcro touch pads that can be worn on top of clothing or on the wheel chair. Each pad is a trigger for a smart phone app to play a pre-programmed phrase. This helps people who have difficult speaking (for example due to ALS or cerebral palsy) to communicate more easily.
  1. Recovery and rehabilitation devices

Also an area in which assistive devices have had their place for a long time, digital enhancements now tailor these types of wearables more to the patient’s needs. A number of companies are working on solutions to increase patients’ mobility – typically using some form of exoskeleton, together with sensors and algorithms to help with movement and recovery.

 

How do these new technologies fit into our healthcare system and how accessible will they be to patients who can benefit from their use?

Our healthcare system is already set up to evaluate new assistive devices, and potentially pay for them. Device makers would have to prove that their inventions are useful and enable patients to live more independently and / or return to work earlier and save or reduce disability payments or insurance costs.

Those who develop the wearables have to figure out which ones of the many institutions that share healthcare costs in our country they should approach to be considered for funding.

Funding is more difficult for wearable devices used in monitoring chronic illness. In most cases, there is no precedent for continuous patient monitoring.  Not only the patient’s engagement in the process is required, but a whole new infrastructure approach to healthcare is needed on the provider side. Currently, neither private practices nor hospitals are set up to receive, monitor and act upon myriad patient data coming in through wearable devices.

Many barriers impede adoption of new technologies for patient monitoring:

  • Concern about the reliability of incoming data – how accurate is the wrist-mounted heart monitor, are there differences between different devices and who is at fault if the device either gives a false positive and triggers an unnecessary medical intervention, or a false negative that puts the patient’s health at risk?
  • Integration with existing technology – how will data come into the clinic, will it be compatible with currently used IT solutions, how can staff easily access the data and how will confidentiality and privacy be safeguarded?
  • Integration into existing work flows – who will review the data, at what intervals, and which actions should follow particular cues? Will healthcare professionals need special training on how to read the data? Is extra staff required? How can incoming data be standardized to avoid confusion?
  • And last, but not least, who pays for the extra time that clinic staff spends on continuous patient monitoring?

Many of us are still in the phase of excitement over the wealth of possibilities that wearable tech affords us for delivering better healthcare. The successful players will be the ones who figure out how the possible can be turned into the doable, and profitable, within the constraints of our infrastructure and funding environment.

What should patients know about their disease?

A recent survey by the Dana-Farber Cancer Institute showed that many women who had surgery for their breast cancer did not know basic facts about their own tumour, such as their HER2 status, their ER status, their tumour stage and grade. @DanaFarber

The lead author of the study, Dr. Rachel Freedman, expressed surprise and concern at these results.

http://www.dana-farber.org/Newsroom/News-Releases/many-women-lack-basic-understanding-of-their-breast-cancer-study-finds.aspx

Why should patients know or care about these things? I have been immersed in the field of healthcare and pharmaceutical market research for more than ten years, but when it comes to my own health, I find I am not really interested in learning about the intricate details of my ailments.

Professionally, I often talk with physicians who make treatment decisions on life-threatening diseases and marketing executives from pharmaceutical companies who promote therapies to treat these diseases. Both of these groups focus a great deal on the minute differences between this drug and that, between different genetic mutations and cellular targets and markers that guide therapy choices. This knowledge is essential to their livelihood and their job. Should it be essential for patients as well?

Let’s draw an analogy to other areas of life.

When my car breaks down I bring it to the mechanic. What I am most interested in is: A) How serious is it? B) Is it fixable? C) How much will it cost to fix it and how much time will it take? I believe the mechanic to have all the knowledge about the different parts in my car and the tools that are needed to fix them, should they break down. I trust my mechanic to give me an honest assessment of the damage and the different options for repairing it (yes, I have an honest one). I don’t need to know anything else. Why should it be different for medicine?

DSC_0651

Or here’s another one:

When I decide whether to buy an Apple smartwatch or a Samsung Gear, I base my decision on things like what apps they offer, how the screen is laid out and which smart gestures they support. How the people at Apple or Samsung get the watch to have these features is irrelevant for me. All I care about is what I can and cannot do with the watch. And whether it looks cool. And how much it costs.

Samsung Gear S

And now back to medicine:

Is it fixable or will I die (soon)? How long do I need to take this therapy for? Will it make me nauseous? Does my insurance cover it? Will it prolong my life? How much of a hassle is it to take it? These are the types of questions that are relevant for a patient.

That’s hard to understand for someone who is focused on the science of medicine. But healthcare is more than science. Extending someone’s life or halting disease progression are only surrogate endpoints. The real endpoints are enabling patients to lead the life that they want, how they want it. These endpoints are, of course, immeasurable.

Confessions of a First Time Wearables User

Since I started my business in healthcare-focused market research, I have been paying attention to wearable devices. Wearables devices have great potential for monitoring health parameters and improving care for certain chronic conditions.

The business press has been making a big deal of wearable devices, predicting exponential market growth over the next few years.

Wearables market growth

I am interested in the user perspective – how useful are these devices, actually? Some statistics show that, similar to fitness club memberships, many people who purchase fitness tracking wrist bands abandon them after a few months of usage.

As an anthropologist, I believe the best way to learn about a certain area of life is to immerse yourself in it, to experience what it feels like and to understand how it works. So I started going to these meet-ups for people engaged in the world of wearable devices. They are awesome!

Run in Steve-Jobs-style corporate presentations by the inspiring wearables guru Tom Emrich, companies in the wearables space present their prototypes and the audience gets to try stuff out in the post-presentation mix-and-mingle. My favorite so far has been the mind-controlled beer tap.

I have met many people in the wearables community, and they are certainly very different in style and outlook to my usual clientele (executives from pharma companies). However, I have hesitated to take the plunge into trying a wearable myself.

I am a pretty fit person, working out two to three times a week, to maintain my health and my sanity, eating pretty healthy, and most of the time walking to public transit rather than taking the car. Whether I run 5 minutes less today than I did last week is not really important to me, as long as I get some exercise every few days. Competing with others along fitness goals does not interest me at all. But I realized that not trying out a wearable myself would deprive me of certain insights that could be essential for conducting the user research that I am so interested in doing.

So I bought a Garmin Vivofit last week. Three things enticed me to purchase this device rather than some of the other ones that are very popular (Jawbone Up, Fitbit, Fuelband).

  1. It shows the time. I am of a generation that still wears a wrist watch, and wearing both a fitness wrist band and a watch separately seemed silly.
  2. Its battery life is supposed to be one year. Charging devices is a big pain, and in my household we are competing for outlets and charger cables to charge the various cell phones, iPods etc for the next morning.
  3. It has a red progress bar that shows up after you have been sitting around for too long. My occupation requires a lot of sitting in front of the computer. I tend to get into a state where I push myself to concentrate only half an hour longer, then another, then another, and then become all tense because I have not taken enough breaks. So a little nudge to get up and walk around seemed like a very useful feature to me.

Garmin Progress Bar

Here are my first experiences with the device:

  • Putting it on is quite uncomfortable. You have to press down on this clip to go into these holes, and doing that hurts the inside of my wrist. Watch wristband makers have certainly figured that one out better. Maybe if you are a tough man you don’t mind. But I’m a lady.
  • The red progress bar is very useful. It has actually helped me take more frequent breaks when I am doing computer work, and I feel better after getting up and walking around for a few minutes.
  • The red progress bar is dumb. This so-called smart device apparently registers only walking activity, i.e. when I swing my left arm back and forth. I was frustrated to see the red bar show up after I spent an hour in the kitchen preparing dinner, and after I was in the back yard, raking and bagging leaves. Apparently, either the sensor or the algorithm don’t realize that these are physical activities.
  • The red progress bar can be fooled. Just for fun, I tried out swinging my arm back and forth for a minute while I was sitting at the dinner table, and it actually tricked the device into registering this as physical activity, so the red bar disappeared.
  • The dashboard that shows my steps and my sleep is kind of interesting. I have only worn the device for a few days, so can’t say yet how useful this data is going to be long-term, if at all, but it’s neat to look at in a narcissistic way – the same way I look at my Twitter account from time to time and delight in the fact that I actually have some followers.

Anyway, it has been a very interesting experiment so far, and definitely proof of the value of ‘walking in the shoes of’ to really understand something.

The true potential of wearables is difficult to tell at the moment. There could be all sorts of useful applications that have not yet been developed or that have not yet gained broad acceptance. After a lot of enthusiasm in the media, there seems to be a bit of a backlash now.

Here’s a recent page from The Atlantic, with quotes of tech opinion leaders all questioning the enthusiasm for wearables:

Atlantic article

And here’s an article written by a health IT consultant about the more technical challenges of integrating mobile health monitoring devices into electronic medical records.

http://medicalconnectivity.com/2014/11/04/challenges-using-patient-generated-data-for-patient-care/

While I share some of the skepticism, the wearables space is certainly an area worth watching, and with great growth opportunities for companies who ‘get it right’. I am excited to be part of this journey.