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Rebalancing Skill Sets In Pharma Sales And Marketing

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A disturbing trend against much needed more job creation across the world, has been well captured in a May 2016 MIT article. It concluded through several complex mathematical models that: “As more tasks performed by labor are being automated, concerns that these new technologies will make labor redundant have intensified.”

However, despite well-hyped concerns in this area, ongoing rapid advancement of technology and other related innovation haven’t yet caused any alarming level of unemployment anywhere in the world, nor it possibly will. Several instances of gradual reduction in the number of routine and traditional jobs due to such automation, are generally related to a lesser level of hard skill sets. As we shall see below, many industries require doing so in the modern times, for long term sustainability of business.

In tandem, promising high tech jobs requiring state or the art hard skill sets are getting created too, though are fewer in number. Nevertheless, the number of brilliant startups has increased by manifolds, during the same period. This change is inevitable, mostly in any science and technology driven industry, e.g., banking sector, where most of human operated bank tellers have made way to ATM machines.

A recent vindication:

Vindicating this point, as it were, on May 18, 2017, Reuters reported that Swiss pharma major Novartis, as a part of its “ongoing global transformation” initiative launched last year to create a unified operating model, will cut around 500 traditional and routine jobs in Switzerland, and add 350 in high-tech areas. Immediately thereafter, for similar reasons, the company announced the elimination of another 250 jobs in the United States.

Jobs are important to all for a living. Any job loss, irrespective of the nature of business compulsion, is indeed unfortunate. That said, whether we like it or not, such evolving trends are the stark realities, and expected to continue or even accelerate in the years ahead for higher growth in productivity, especially involving the routine and traditional tasks.

Pharma industry, though a science-based one, loss of routine and traditional jobs due to technological advancement is fortunately still much less as compared to other similar industries. This is primarily due to the continuation of the traditional business models in the pharma sector, requiring a huge number of human intervention, which call for a different balance of soft and hard skill sets.

However, crystal gazing the future, it appears quite likely that there will be a strong need to rebalancing the required soft and hard skills in the drug industry. The contour of my discussion in this article will be on pharma sales and marketing. 

Skill – the ability to do something well:

The Oxford dictionary defines ‘skill’ as ‘the ability to do something well’. Similarly, the term ‘ability’ has been defined by it as ‘possession of the means’. Thus, ‘skill’ means ‘possession of the means to do something well’. It is an absolute must in all professions, including pharma sales and marketing.

Skills broadly fall into two categories – hard and soft skills. Hard skills involve specific knowledge and teachable abilities that can be defined and measured and are usually quantifiable.

Hard skills are individual proficiency in various scientific, technical, mathematical and even some artistic areas of creation, besides other related ones. In pharma sales and marketing arena of the near future, these include, among others, robust scientific knowledge-base to understand various aspects of drug molecules, content creation with astute market understanding, data generation and analysis through state of art analytics and research, software programing, digital savviness and social media expertise. Many of these skills are related to the Intelligent Quotient of an individual.

Soft skills, on the other hand, are less tangible and quantifiable, such as etiquette or personality development; work ethics, getting along with people, ability to listen patiently, overcoming objections, persuading others and a deep sense of accountability. Many of these skills are usually related to emotional intelligence of an individual.

Which one is more important?

Both hard or soft skills are useful, valuable and important. However, the mix of these two skills for high performance of any individual professional will generally depend on success requirements of a job in a specific macro business environment.

That said, it is important to note that most of the hard skills are taught and learnt mostly before a person’s entry into science, technology or various other craft or design based jobs. The related hard skills are essential for getting selected for specialized jobs. Whereas, softer skills are usually learned on the job, and through experience by all those who want to grow in the profession.

In this context, it may not be a bad idea for all pharma sales and marketing professionals to take a hard look at our own current soft and hard skill sets again, against rapidly changing demands of the business environment. Regardless of where we are now, it will be worth writing down on a piece of paper the type of each of these two skills, in order of their strengths, that we individually possess, which are good enough for achieving sustainable excellence in business performance and personal career progression. It may provide a broad sketch of where we stand today in the VUCA world.

The years ahead for pharma won’t be quite the same:

A strong wind of change has already started signaling that the years ahead for the pharma industry, won’t be quite the same as the bygone years nor like what it is today. Some, industry professionals have picked up this cue, while many are still in pursuit of replicating the traditional past with some digital tweaking here and there, whatever may be the reasons.

The current mix of skill sets of the sales and marketing professionals, quite perceptibly, tilts more towards sharpening the softer skills of the employees, as the traditional pharma business models prompt so.

Future need – rebalancing the skill sets:

To be a successful in the days ahead, pharma companies would need to dive deep into the cyberspace – just to be on the same wavelength with its important stakeholders, including, the Government.

Looking around, one witnesses many patients going digital at a faster pace than ever before. They enjoy the cyberspace while embracing the new ways of living life, such as – communicating digitally, chatting in WhatsApp sharing patient’s experience, interacting with online patient communities, and preferring data mining to know more about anything of interest. These activities also get them a sense of the differential advantages of various health care products, services and their cost, before or while consulting doctors and deciding what they can afford.

Similarly, many medical professionals are also not depending solely on the company representatives now to get relevant details on any medicinal product, device or services. Besides frequent interaction with their peer groups, they get such detail information from various websites run by independent, and credible expert groups.

Thus, one of the common arena for pharma stakeholder engagement and interaction would soon be the enigmatic Cyberspace. As the changing days come nearer, there is likely to be greater emphasis on the acquisition of talent having specialized hard skills in this area of sales and marketing.

This emerging scenario prompts rebalancing the mix of soft and hard skill sets with much greater care, and hire young sales and marketing professionals, accordingly to give shape to it. This process should commence now, as the present makes way for the future. This is so important because, the current trend of tweaking with many digital tools and devices mostly as interfaces, or for complementing in-person product detailing or for better field management, or even to draw up marketing and sales plans, may not yield the desired business results any longer, even for survival, as we move on.

Becoming digital natives?

According to the 2015 A.T. Kearney Report titled, “Time for Pharma to Dive into Digital”, pharma sales and marketing professionals must also become digital natives, providing content that is both up-to- date and appropriate for multiple digital channels. Moreover, they will have to be familiar with advanced analytics to monitor and measure actual consumption pattern, besides capturing in real time a huge sample of relevant data for deeper customer insights.

The new normal:

One of the biggest challenges would be in the approach to content development and management. Creating an interactive detailing toolbox for truly responsive customer engagement, requires a good deal of thought and quite complex coding. This would necessitate centralization of marketing content production, which is traditionally decentralized in many sales and marketing organizations. Similarly, the major focus of the sales force will shift from maximizing physician-call rates, to becoming a team of digital communication specialists, and coordinators who would ensure that the right channels are used at the right time.

As the November 2016 Accenture Report titled, ‘The Rebirth of The Pharmaceutical Sales Force’ underscores, the most successful pharmaceutical sales teams in the future will be those willing to define and servicing customers in new ways… and will use digital advances to change the conversation, and position themselves as committed to helping physicians improve health outcomes.

This expected change, I reckon, will put in place a new normal for pharma sales and marketing success in the years ahead.

In conclusion:

Young aspirants wanting to make a career in the pharma industry, may wish to take note of this evolving trend of inevitable changes. They may wish to get well-considered views on the same of a couple of experts’ having no conflict of interest, for a careful and independent personal assessment. These budding strivers should realize that the final actionable decision on developing requisite hard and soft skill sets for a successful take off in their respective working lives, should preferably be taken only by themselves, and none else.

An August 2015 article of McKinsey & Company titled, “The road to digital success in pharma” articulates that the pharma companies, though can play a central role in the digital revolution of healthcare, are running hard to keep pace with changes brought about by digital technology. But soon there may not be any other option left for achieving business excellence.

While the nation is taking strides to transform itself into ‘Digital India’, the pharma companies operating in the country can’t possibly afford to remain far behind. Willy-nilly, they will soon need to realign their business processes accordingly, as there may not be any further scope for individual pharma players to operate within the same old cocoon of tradition bound activities, and still survive.

To meet the new and tougher demands for excellence in pharma sales and marketing, the urgent need of the changing time lies squarely outside the box. To usher in a requisite transformation in the current business model, it calls for a series of well-calibrated, much researched, and bold steps – skillfully rebalancing the crucial soft and hard skill sets, achievable within a realistic and self-determined timeframe.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Stem Cell Therapy in India: A Potential Game Changer in Disease Treatment

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Stem Cells (SC) offer an incredible potential to instill a new lease of life virtually to any organ of the human body, bringing them back to the pre-disease state through its own biological repair mechanism. Intensive research initiatives are on across the world to harness this unique possibility that will be able to successfully address a plethora of serious and chronic ailments for mankind. The good news is, the global scientific community is taking rapid strides in understanding the complex stem cell biology to give shape to a game changing medical treatment blue print for tomorrow.

Capturing one such pursuit, on February 21, 2017, well-reputed British news daily – ‘The Telegraph’, reported the outcome of a path-breaking medical study for freezing the progression of yet another complex and crippling ailment – Multiple Sclerosis (MS). This research followed a unique SC transplantation process. Intriguingly, both such diseases and the treatment are not generally much talked about, particularly in India. If done, it would increase public awareness and help many patients fetch greater benefits from the available and approved SC therapy in the country. Probably, considering the unfathomable scope of the body’s own repairing toolbox with SC, Prime Minister Narendra Modi reportedly called on Indian biologists to motivate school children for pursuing a career in stem cell research.

Let me now go back for a moment to Multiple Sclerosis (MS) as I am aware of this this disease condition rather closely. One of our close family friends who was a very senior official in one of the top multinational corporations of the world, had to give up his job prematurely being a victim to this serious illness. In that sense, this particular news item rekindles a new hope for many to look for a better quality of life while managing many other diseases of such kind, all over the world, including India.

‘The Telegraph’ reported: in so far, the largest long-term follow-up of SC transplantation treatment study of MS, which was spearheaded by Imperial College London, established that 46 per cent of patients who underwent this treatment did not suffer a worsening of their condition for five years. The treatment works by destroying the immune cells responsible for attacking the nervous system. This is indeed a very significant development in the space of medical research.

This new treatment, called autologous hematopoietic stem cell transplantation (AHSCT), was given to patients with advanced forms of MS who had failed to respond to other medications. However, the researchers noted that the nature of the treatment, which involves aggressive chemotherapy, carried “significant risks”.

It’s worth recapitulating here that MS is caused by the immune system malfunctioning and mistakenly attacking nerve cells in the brain and spinal cord, leading to problems with movement, vision, balance and speech. It’s a lifelong condition and often causes serious disability, with no cure still in sight. The disease is most commonly diagnosed in people in their 20s and 30s, although it can develop at any age.

A new hope with a game changing potential:

The above study of SC transplantation conducted by Imperial College London in MS, is just a recent example, among scores of major steps being taken in this frontier of medical science in preparation of a decisive battle against many more life-threatening and serious debilitating diseases.

No doubt that various treatments involving stem cells are generally considered a novel and rapidly advancing medical technology. However, in a small number of developed countries, such as the United States (US), a number medical procedures with stem cells are being practiced since around last three decades. Bone marrow transplant is the most widely used stem-cell therapy in this area, which was first performed in 1968.

According to California Institute for Regenerative Medicine (CIRM) and various other medical literature, SC treatment has the game changing potential for successful use to:

  • Replace neurons damaged by spinal cord injury, stroke, Alzheimer’s disease, Parkinson’s disease or other neurological problems
  • Produce insulin that could treat people with diabetes and heart muscle cells that could repair damage after a heart attack, or
  • Replace virtually any tissue or organ that is injured or diseased

Thus, stem cells offer limitless possibilities, such as tissue growth of vital organs like liver, pancreas. Today there are many diseases for which no effective treatment still exists, besides giving symptomatic relief, such as Multiple Sclerosis, Parkinson’s disease, Alzheimer’s, severe burn, spinal cord injury. There is a host of other diseases, including several chronic ailments, such as diabetes, heart ailments, rheumatoid arthritis, or some types of cancer, which can’t just be reversed, however, could be managed with a lifelong treatment. For most of these diseases, and several others involving tissue degeneration, SC therapy has the potential to be a huge life and a game changer. It may involve, besides patients, several industries, including pharmaceuticals and biotech sectors.

Major stem cell sources and some key milestones:

Medical scientists and researchers have conclusively established that stem cells are the master cells of any human body. These are undifferentiated cells of the same lineage, retaining the ability to divide throughout life and grow into any one of the body’s more than 200 cell types. Some of the major sources of stem cells in the human body are bone marrow, cord blood, embryonic cells, dental pulp and menstrual blood.

As captured by ‘ExploreStemCells’ of UK, some key events in stem cell research include:

  • 1978: Stem cells were discovered in human cord blood
  • 1981: First in vitro stem cell line developed from mice
  • 1988: Embryonic stem cell lines created from a hamster
  • 1995: First embryonic stem cell line derived from a primate
  • 1997: Cloned lamb from stem cells
  • 1997: Leukemia origin found as hematopoietic stem cell, indicating possible proof of cancer stem cells
  • 1998: University of Wisconsin isolated cells from the inner cell mass of early embryos and developed the first embryonic stem cell lines.
  • 1998: Johns Hopkins University derived germ cells from cells in foetal gonad tissue; pluripotent stem cell lines were developed from both sources.
  • 1999 and 2000: Scientists discovered that manipulating adult mouse tissues could produce different cell types. This meant that cells from bone marrow could produce nerve or liver cells and cells in the brain could also yield other cell types.

All these discoveries were exciting for rapid progress in the field of stem cell research, along with the promise of greater scientific control over stem cell differentiation and proliferation. Currently, many more research studies are underway in globally acclaimed institutions and other boutique laboratories exploring the possibility of wide scale use of SC therapy, even in the treatment of several chronic diseases, including diabetes and heart disorders.

A controversy:

The controversy related to SC research mainly involves Embryonic Stem Cells (ESC) and raises several difficult questions for a speedy resolution. As articulated by the ‘Genetic Science Learning Centre’ of the University of Utah, these are mainly:

  • Does life begin at fertilization, in the womb, or at birth?
  • Is a human embryo equivalent to a human child?
  • Does a human embryo have any rights?
  • Can destruction of a single embryo be justified to provide a cure for a countless number of patients?
  • Since ESC can grow indefinitely in a dish and can, in theory, still grow into a human being, is the embryo really destroyed?

However, in 2006 scientists learned how to stimulate a patient’s own cells to behave like embryonic stem cells. These cells are reducing the need for human embryos in research and revealing exciting new possibilities for stem cell therapies, according to this Centre.

Stem cell research in India:

India has pursued SC research since over a couple decades reasonably supported by the Government, especially the Department of Biotechnology (DBT), besides several remarkable initiatives from the private sector. Ethical guidelines in this regard are also in place, so also are the National Guidelines for Stem Cell Research in India. These guidelines are aimed at obtaining licenses from the Drug Controller General of India (DCGI).

Further, in a major move to regulate and oversee the activities by streamlining SC research in the country, the Government has also set up an Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) and the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT). This necessitates the researchers on human stem cells, both institutions and the individuals, to be registered with NAC-SCRT through IC-SCRT. To ensure that the concerned companies and individuals follow the National Guidelines, these committees will review, approve and monitor each research project in this area. It now calls for even greater focus from all other stakeholders to help accelerate growth of this niche segment of medical science for patients’ benefits.

SC transplantations using umbilical cord blood and bone marrow for treating neurological, hematological, hepatic and cardiac disorders are being pursued by some well-known medical institutions, such as, AIIMS, PGI Chandigarh, CMC Vellore, AFMC Pune, Manipal Hospital Bangalore. For example, AIIMS, reportedly, undertook a major multi-center trial to look at the role of stem cells in repairing tissue damaged during acute heart attacks, where other treatment process, including a cardiac bypass surgery fails to adequately improve the heart function. Similarly, Shankar Netralaya in Chennai has successfully carried out limbal stem cell transplantations for restoring vision to several patients.

That said, this is a cost intensive area of research, which involves expensive equipment, reagents and other consumables. Moreover, ensuring continuous training for SC researchers and clinicians also poses a major problem. Greater international collaboration in this area, and increasing number of Public-Private-Partnership (PPP) could accelerate the progress of India in this hugely promising area of medical science, reaping a rich harvest for a large patient population of the country.

Stem cell banking:

SC banking is a fast-developing area in this field, especially designed for SC therapy. As not many patients are not currently as much aware or interested in SC therapy as they ought to, it may not appear as an immediate requirement for many. However, an encouraging trend is fast catching up, especially within some enlightened persons, to have in a bank a large reserve of their own or their baby’s stem cells that would be available for any medical emergencies or more effective treatment options, in the future.

It assumes increasing importance because, as we age, illness and the natural process of aging could reduce the number of stem cells available to regenerate organs, muscles and bone. At that time, while treating a serious illness or a grave injury, a person may have fewer adult stem cells that have the collective power to make an effective healing response to SC therapy.

In that context, SC banking provides a great opportunity to store, multiply and utilize a newborn’s or even an adult person’s younger and healthy stem cells for SC therapy during any medical emergency, such as a serious accident or a crippling illness, at a later stage in life.

There are broadly the following two types of SC banking facilities are now available in India:

A. Cord blood stem cell banking:

This is type of SC banking is the process of collecting, processing, cryogenically freezing and preserving the ‘Cord blood’ that remains in the vein of the umbilical cord and placenta at the time of birth, for potential future medical use during SC therapy. Stems cells extracted from the umbilical cord blood have been shown to be more advantageous than those extracted from other sources such as bone marrow. These banked stem cells are considered as a perfect match for the lifetime of the donor baby, and for other family members, as well. This is significant as there exists a greater chance for success in a stem cell transplant between siblings than with unrelated donors and recipients.

B. Adult stem cell banking:

Some state-of-the-art adult stem cell banking services are either already available or in the process of coming up in many places of the world, including India. As an individual’s fat (adipose tissue) is an important source of adult stem cells, with the application of a high precision medical technology of separating, multiplying, and storing adult adipose tissue-derived mesenchymal stem cells for autologous use by physicians, ‘Adult stem cells are stored in these banks.

The good news is, increasing awareness in this area has now started prompting many parents, and also some adults to bank or store their own SC and the baby’s cord blood rich with a specific types of stem cells, that can be utilized, at a later date, in a variety of SC therapy while treating many life-threatening and debilitating diseases, if required.

Types of stem cell therapy:

There are two major types of SC therapies, and both are available in India:

  • Autologous stem cell therapy: uses the adult patient’s own stem cells obtained from the blood, bone marrow.
  • Allogenic stem cell therapy: uses donated stem cells, but faces chances of donor stem cell rejection.

As articulated in the revised stem cell guidelines, stem cells can’t be offered to patients in India as ‘therapy’ unless these are proven effective and safe supported by unequivocal clinical trial data and approved by the DCGI. Otherwise, these can be used only in ‘clinical trials’ as will be approved by the DCGI. The only exception to this is the use of haematopoietic (blood forming) stem cells for treating blood disorders, which is considered as ‘a proven therapy,’ according to available reports.

The Market – Global and India:

September 14, 2015 issue of ‘The Pharma Letter’ stated based on a recent report that the global stem cells market was valued at US$ 26.23 billion in 2013, and is estimated to be worth US$ 119.52 by 2019, registering at a Compounded Annual Growth Rate (CAGR) of 24.2 percent. Whereas, in India, the stem cell market is expected to be around US$ 600 million by 2017. Another report, titled ‘India Stem Cells Market Forecast & Opportunities, 2020’ of ‘Pharmaion’, states that stem cells market in India is expected to grow at a CAGR of over 28 percent during 2015 – 2020.

In terms of services offered, stem cells market in India has been segmented into two main categories, namely SC banking, and SC research. The latter dominated the market in 2014, and is likely to continue its dominance through 2020. Adult stem cells accounted for the majority share in India’s SC market in 2014, as a lot of research being carried out using adult stem cells, besides growing adult stem cell banking and other associated applications in therapeutics.

The major growth drivers for SC market are: increasing patient awareness, an increase in the approval for clinical trials in stem cell research, growing demand for stem cell banking services,

Government support, rising investments in research, and ascending trend of development for regenerative treatment to meet unmet medical needs.

The first stem cell based product approval in India:

On May 30, 2016, a Press Release of ‘Stempeutics Research’ of Bengaluru announced that for the first time in India, DCGI has granted limited approval for manufacturing and marketing of its allogeneic cell therapy product named Stempeucel® for the treatment of Buerger’s Disease – a rare and severe disease condition affecting the blood vessels of the legs, which finally may require amputation. Stempeucel® treatment is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularization. The prevalence of Buerger’s Disease is estimated to be 1,000,000 in India and two per 10,000 persons in the EU and US, as the release stated. Stempeutics Research’ is a company of Manipal Education & Medical Group and a Joint Venture with Cipla Group.

Conclusion:

Research on stem cells, across the world, is taking rapid strides. It has already demonstrated its healing power in changing many human lives either by significantly stalling the progression of several serious ailments, such as Multiple Sclerosis (MS), or reversing the disease conditions, such as serious damage to the heart caused by massive myocardial infarction.

An increasing number of stem cell banks coupled with growing public and private investments in stem cell research, positive narratives are getting scripted for this space in India. With rapidly growing middle class population and comparatively less stringent rules and regulations, India is emerging as a perfect destination for many more global and local stem cell banking companies. Consequently, the stem cell market in the country is expected to witness robust growth in the coming years.

However, only future research on stem cells will be able to unravel whether an Alzheimer’s victim will get back the stolen memory; a cancer patient won’t have to mentally prepare to die of cancer anytime soon, besides spending a fortune towards cancer therapy; an insulin dependent diabetic will no longer require insulin; an individual with damaged heart won’t have to continue with lifelong medication, and it goes on and on.

Nevertheless, if it does… and God willing – it will, ‘Stem Cell Therapy’ would not just be a life changer for many patients, it will be a game changer too for several others, including the pharma, biotech companies and many more within the healthcare sector. If any skeptic still asks, will it really happen? My counter question, in response, will be: Why not?… Why the hell not?

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Millennial Generation Doctors And Patients: Changing Mindset, Aspirations, And Expectations

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The term ‘Millennial Generation’ normally refers to the generation, born from 1980 onward, brought up using digital technology and mass media. According to ‘Millennial Mindset’ – a website dedicated to helping businesses understand millennial employees and new ways of working, the key attributes of this generation are broadly considered as follows:

  1. Technology Driven:
  2. Socially Conscious
  3. Collaborative

The millennial mindset:

The publication also indicates that the overall mindset of the millennial generation is also vastly different from the previous generations, which can fall into four categories:

  1. Personal freedom, Non-hierarchical, Interdependent, Connected, Networked, Sharing
  2. Instant gratification, Wide Knowledge, Test and learn, Fast paced, Always on, Innovative
  3. Fairness, Narcissistic, Purpose driven
  4. Balance, Eco-friendly and Experience focused

Seeks different professional ecosystem:

In the professional arena too, this new generation’s expectations from the professional ecosystem are often seen to be distinctly different, as they are generally seen to be:

  • Willing to make a meaningful professional contribution, mostly through self-learning
  • Seek maintaining a reasonable balance between work and personal life
  • Prefer flexible work environment, unwilling to be rigidly bound by convention, tradition, or set rules
  • Impatient for fast both personal and organizational growth, often on the global canvas

The ‘Millennial Generation’ in India:

The millennium generation with a different mindset, aspirations and value system, already constitutes a major chunk of the Indian demography. According to the 2011 Census, out of estimated 1.2 billion population, around 701 million Indians (60 percent) are under 30 years of age, which also very often referred to as ‘demographic dividend’ of India.

Currently, a large number of Indians belonging to the millennial generation are entering into the work stream of both national and International companies operating in the country.

The challenge in healthcare arena:

In the healthcare sphere too, we now come across a fast increasing number of technology savvy and digitally inclined patients and doctors of this generation. Accurately gauging, and then meeting with their changing expectations has indeed been a challenging task for the pharma companies, and the related service providers.

Their expectations from the brands and other services, as provided by the pharma companies, don’t seem to be quite the same as before, either, so are the individually preferred communication formats, the way of processing, and quickly cross-verifying the product and other healthcare information. Before arriving at any decision, they were found to keenly observe the way brands are marketed, their intrinsic value, type and the quality of interface for engagement with them by the companies, whenever required.

Thus, from the pharma business perspective, qualitatively different strategic approaches, to both the millennial doctors and patients, would be of increasing importance and an ongoing exercise. The goal posts would also keep moving continuously. Achieving proficiency in this area with military precision, I reckon, would differentiate the men from the boys, in pursuit of business performance excellence.

In this article, I shall primarily discuss on the changing mindset and needs of the patients and doctors of the ‘millennial generation’.

A. Treating millennial patients differently:

Around 81 percent of millennial doctors, against 57 percent of older generation doctors think that millennial patients require a different relationship with their doctors than non-millennial patients. About 66 percent of millennial doctors actually act upon this and change their approach, as the survey reported.

The difference:

The key differences on millennial doctors’ treating millennial patients, are mainly in the following areas:

  • Expects more, doesn’t get swayed away: Millennial doctors are more likely to advise the millennial patients to do additional research on their own for discussion. 71 percent of millennial doctors believe it’s helpful for patients to do online research before their appointment. However, they don’t get swayed by requests from more-informed patients, as only 23 percent of millennial doctors say they are influenced by patient requests when it comes to prescribing a treatment, whereas 41 percent of non-millennial doctors report finding those requests influential.
  • Gets into the details: The millennial doctors are more likely to simplify and streamline explanations for older patients, whereas non- millennial doctors were more likely to simplify explanations for millennial patients too, treating them exactly the same way.
  • Relies on digital resources: Millennial doctors rely mostly on using digital resources for treating millennial patients, but only around 56.5 percent of them do so for non-millennial patients.

B. Treating millennial doctors differently:

For effective business engagement and ensure commensurate financial outcomes, pharma companies will first require to know and deeply understand the changing mindset, expectations, and aspirations of the millennial doctors, then work out tailor-made strategic approaches, accordingly, to achieve the set objectives.

Top 3 expectations from the pharma industry:

According to a June 2016 special survey report on Healthcare Marketing to Millennials, released by inVentive Health agencies, the top 3 expectations of millennial and non-millennial doctors from the pharma industry, are as follows:

Rank Millennial Doctors % Rank Non- Millennial Doctors %
1. Unbranded Disease Information 67 1. Unbranded Disease Information 58
2. Discussion Guides 48 2. Latest Specific News 46
3. Adherence Support 40 3. Healthy Life Style Information 42

Pharma players, therefore, can provide customized offerings and services, in various innovative platforms, based on these top 3 different expectations of millennial and non-millennial doctors, to achieve much needed critical competitive edge for a sustainable business performance.

Brand communication process needs a relook:

The above report also noted a number of the interesting trends related to the millennial doctors. I am quoting below just a few of those:

  • Only 16 percent of millennial doctors found pharma promotional materials to be influential when considering a new treatment compared to 48 percent of non-millennial doctors who do.
  • 79 percent of them refer to information from pharmaceutical companies only after they’ve found that information elsewhere.
  • 65 percent of these doctors indicated, they did not trust information from pharmaceutical companies to be fair and balanced, while only 48 percent of their older peers shared that sentiment.
  • 50 percent found educational experiences that are driven by their peers to be the most relevant for learning and considering about new treatments, against 18 percent of non-millennial physicians.
  • 52 percent of them, when learning about new treatment options, favor peers as their conversation partners.
  • They are much more likely to rely on a third-party website for requisite product or treatment information
  • 60 percent of millennial doctors are more likely to see a pharma rep, if they offer important programs for their patients, compared to only 47 percent of non-millennial doctors. This also reflects greater patient centric values of the millennial doctors.
  • However, an overwhelming 81percent of millennial doctors believe that any type of ‘Direct To Consumer (DTC)’ promotion makes their job harder, because patients ask for medications they don’t need.
  • 41 percent of millennial doctors prefer a two-way and an in-person interaction, against just 11 percent of them with online reps. Here, it should be noted that this has to be an ‘interaction’, not just predominantly a monologue, even while using an iPad or any other android tablets.

Redesigning processes to meet changing expectations and needs:

Thus, to create requisite value, and ensure effective engagement with millennial doctors, the pharma companies may consider exploring the possibility of specifically designing their entire chain of interface with Millennials, right from promotional outreach to adherence tools, and from medical communications to detailing, as the survey report highlights. I shall mention below just a few of those as examples:

Communication platforms:

For personal, more dynamic and effective engagement, non-personal digital platforms – driving towards personal interactions with company reps, together with facilitating collaboration between their professional peer groups, came out as of immense importance to them.

Adherence and outcomes:

There is a need for the pharma companies to move the strategic engagement needle more towards patient outcomes. This is mainly because, medication adherence is a large part of the patient outcome equation. It involves a wide range of partnerships, such as, between patients and physicians, and also the physicians and pharma players. This particular need can be best met by offering exactly the type of collaborative approach that millennial doctors favor.

Medical communication:

Redesigning the core narrative of medical communication around a disease state and product, engaging the wisdom and enthusiasm of scientific, clinical, and educational leaders primarily to serve a well-articulated noble cause, are likely to fetch desired results, allaying the general distrust of millennial doctors on the pharma companies, in general.

Medical representative:

Earning the trust of the millennial doctors by respecting, accepting, and appealing to their value systems, is of utmost importance for the medical reps. To achieve this, drug companies would require to equip their reps with tools and programs that offer value in terms of patient support and adherence, while demonstrating compelling outcomes with a positive patient experience, and greater efficiency in treatment decisions.

Building reputation:

The “Purpose Generation” – that’s how millennials are often referred to. In that sense, to build a long lasting business reputation among them, pharma companies need to be in sync with this new generation.

Weaving a trusting relationship with them involves meeting all those needs that these doctors value, such as, adherence solutions, innovative patient support programs, and creating shared value for communities. This would mean, for many drug companies, charting an almost uncharted frontier, where there aren’t many footsteps to follow.

Need to induct younger generation to top leadership positions faster:

To capture these changes with precision, and designing effective engagement strategies for millennial patients and doctors accordingly, an open, innovative and virtually contemporary mindset with a pair of fresh eyes, are essential. As against this, even today, many ‘Baby Boomers’ (born approximately between 1946 and 1956), who have already earned the status of senior citizens, meticulously nursing a not so flexible mind with traditional views, still keep clutching on to the key top leadership positions in the pharma industry, both global and local.

This prevailing trend encompasses even those who are occupying just ornamental corporate leadership positions, mostly for PR purpose, besides being the public face of the organization, sans any significant and direct operational or financial responsibilities. Nevertheless, by pulling all available corporate levers and tricks, they hang-on to the job. In that way, these senior citizens delay the process of change in the key leadership positions with younger generation of professionals, who understand not just the growing Millennials much better, but also the ever changing market dynamics, and intricate customer behavior, to lead the organization to a greater height of all round success.

I hasten to add, a few of the younger global head honcho have now started articulating a different vision altogether, which is so relevant by being a community benefit oriented and patient centric, in true sense. These icons include the outgoing GSK chief Sir Andrew Witty, who explains how ‘Big Pharma’ can help the poor and still make money, and the Allergan CEO Brent Saunders promising to keep drug prices affordable. Being rather small in number, these sane voices get easily drowned in the din of other global head honchos, curling their lips at any other view point of less self-serving in nature. Quite understandably, their local or surrounding poodles, toe exactly the same line, often displaying more gusto, as many believe.

Conclusion:

The triumph of outdated colonial mindset within the drug industry appears to be all pervasive, even today. It keeps striving hard to implement the self-serving corporate agenda, behind the façade of ‘Patient Centricity’. When the demography is changing at a faster pace in many important countries, such as India, a sizeable number of the critical decision makers don’t seem to understand, and can’t possibly fathom with finesse and precision, the changing mindset, aspirations and expectations of the millennial generation doctors and patients.

Expectedly, this approach is increasingly proving to be self-defeating, if not demeaning to many. It’s affecting the long term corporate performance, continually inviting the ire of the stakeholders, including Governments in various countries.

From this perspective, as the above survey results unravel, the millennial doctors and patients, with their changing mindset, aspirations, expectations and demands, look forward to an environment that matches up with the unique characteristics and values of their own generation.

To excel in this evolving scenario, especially in India – with one of the youngest demographic profiles, proper understanding of the nuances that’s driving this change, by the top echelon of the pharma management, is of utmost importance. Only then, can any strategic alignment of corporate business interests with the expectations of fast growing Millennials take shape, bridging the ongoing trust deficit of the stakeholders, as the pharma industry moves ahead with an accelerated pace.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Patient Services: No Longer An Optional Competitive Driver

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The emerging global trend of patients’ demand for greater engagement in their treatment decision making process, could well be a game changer in the prescription demand generation process for pharma brands, even in India, and in not too distant future. This would assume a critical importance not just from the patients’ perspective, but also for the pharma companies and other health care players, for commercial success.

The fast penetration of Internet services is increasingly becoming a great enabler for the patients to get to know, learn and obtain more and more information about their fitness, overall health, various illnesses, disease symptoms, available diagnostic tests, including progress in various clinical trials, besides the drugs and their prices – and all these just with several clicks.

Thus, equipped with relevant information from various dependable and user-friendly sources from the cyberspace, patients have started asking probing questions about the risks and benefits of various types of treatment decisions and diagnostics tests, when recommended by the doctors. At times, especially in the Western world, such interactions even lead to changes, additions or deletions in the choice of therapy, including drugs, devices and diagnostics tests.

Even in a developing country, such as India, many of such types of patients would no longer want to play just a passive role in their disease treatment or health and fitness improvement processes. Although, they would continue to want the doctors to take a final decision on their treatment, but only after having meaningful interactions with them.

A 2016 Report: 

An April 2016 report of Accenture titled, “The Patient is IN: Pharma’s Growing Opportunity in Patient Services,” finds that the patients in the top global pharma markets want and expect consistent services coming from the pharma companies.

These patients are increasingly seeking more services from the pharma players before they are treated for a disease, regardless of the types of illnesses they have. However, it’s more important to note that patients’ responses during this survey have clearly indicated that while they highly value the services they use, a vast majority of them do not know about the services, which, as the pharma companies claim, are already available for them.

The Accenture study covered 203 executives at pharmaceutical companies, 100 in the United States and 103 in Europe (8 countries) from October to November 2015, covering seven therapeutic areas: heart, lung, brain, cancer, immune system, bones, and hormones/metabolism. Annual revenues of the surveyed companies ranged from nearly US$ 1 billion to more than US$ 25 billion.

Some important findings:

Following are some key findings of this report:

1. Patient services are delivering value with a significant increase in focus, and investment expected over the next two years, with 85 percent of companies are raising their investment in patient-centric capabilities over the next 18 months. However, the companies have only become slightly more patient-centric over the past two years. 9 of the following top 10 services are attracting above average business impact, which is an increase over hopping 73 percent that currently offer such patient services:

  • Disease education
  • Patient segmentation and insight
  • Patient experience management
  • Medication delivery/support
  • Patient risk assessment
  • Wellness information and health management
  • Nurse/ physician/patient access portal
  • Medication/ treatment reconciliation
  • Patient outreach, reminders, and scheduling
  • Adherence program management

2. Digital platforms play a dominant role in making patients aware of the services offered. Thus, companies are going big with investments in digital engagement technologies and supporting analytics, with 95 percent of companies planning to invest in patient engagement technologies over the next 18 months.

3. Much of this investment (but not all) is aligned to what patients value. 50 percent of the following top 10 fastest growing services are perceived by the patients delivering significant value:

  • Benefit coverage and access support
  • Health coach/counselor
  • Adherence program management
  • Co-payment assistance programs
  • Remote monitoring
  • Affordability and reimbursement support
  • Nursing support services
  • Reward/ incentive programs
  • Medication delivery/support
  • Patient outreach, reminders, and scheduling

Out of these, ‘medication delivery and support’, ‘remote patient monitoring’ and ‘adherence program management’ were highly valued by 85, 79 and 77 percentages of patients, respectively.

To give an example, pharma companies in the United States use digital as the primary channel for direct communications for patients. They use social media (51 percent) and web pages (49 percent) to market patient services. The use of TV is around 53 percent.

The challenge:

Let me re-emphasize here, as on date, just 19 percent of the surveyed patients are familiar with already available services meant for them. This had happened, despite respective pharma companies’ basic reliance and dependence on health care professionals for dissemination of their respective well-targeted services.

Thus, lack of awareness among patients about the services provided, throws a major challenge to pharma players to accurately ascertain, finding out effective ways, and then continuously measure and evaluate the impact of those services on outcomes, to further hone the process. Such a mechanism needs to be put in place before channeling further major investments in this important space.

Key takeaways:

Following are the key takeaways from this study:

  • Patient services will become a competitive driver and are no longer optional for pharmaceutical companies.
  • Investment should be led by what patients value, but measuring business value is critical to sustainability.
  • Clear organizational and operating strategy must be in place to ensure companies are structured for success.
  • Effective communication to patients the economic value of services, is central to healthcare professional interactions.

Patient-services strategy:

Accenture’s North American Managing Director of patient-services epitomized the findings of the report during its release on April 2016 by saying, “In this changing competitive environment, the question will no longer be if life sciences companies should offer these services, but rather which ones, and how they should be implemented.”

Thus, development of a robust patient-services strategy by the pharma players, that syncs well with the patients’ needs on the ground, will be absolutely necessary for the pharma players, as we step into the future. More importantly, there should be an effective alignment of the strategy with different health care professionals, through effective communication of various types and kinds, to ensure that the brand value offerings, well supported by carefully tailored patients’ services, generate a synergistic outcome for the target group.

Conclusion:

Patient services are increasingly assuming importance of a cutting-edge competitive driver of success in the pharma business. Accordingly, various types of such services have already started attracting greater investments, especially in the Western part of the globe, and are soon expected to become a key competitive driver of success in the healthcare market of India too.

However, while crafting an effective patient-services strategy, one-size-fit-all type of approach won’t work. This is primarily because, not just the service requirements would vary within patients or patient groups, the method of the preferred service delivery mechanism would also vary. For example, some patients may prefer to engage with their doctors for this purpose, some others’ preference could well be Internet based interactive digital platforms, or through a smart app available in a smartphone.

Thus, to succeed in this area for business excellence, pharma marketers must find out the most effective ways to offer these services to each types or groups of patients.

Moreover, the patient services strategy should be an ongoing exercise, as the target groups’ needs of the types of services, and preferred delivery platforms for the same would also keep changing over time.

In India too, quite slowly though, but steadily, the process of arriving at treatment decisions for the patients is undergoing a metamorphosis. Taking a fast mover advantage in the country, in a big way and now, would help reaping a rich harvest, in the near future.

Are Indian pharma players too taking note of this shifting paradigm for sustainable business excellence?

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion. 

 

NCDs: Any Wolf Around, In Sheep’s Clothing? 

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Noncommunicable Diseases (NCDs), such as, cancer, cardiovascular disease, diabetes and chronic respiratory disease, are now the leading cause of death in the world, accounting for 63 percent of annual deaths. Over 80 percent of NCDs occur in lower or middle income countries.

Moreover, wide prevalence of NCDs and inadequate patients’ access to related drugs have a profound negative impact on the economic progress of any country. According to various reports, the increase of around just one year of a country’s average life expectancy, could increase its GDP growth by around four percent.

Since long, the global drug industry has been contributing immensely to discover and bring to the market various amazing medicines to effectively treat a spectrum of NCDs. It is still happening, but with a stark different impact on the majority of the patients, across the world. 

There are many important aspects to NCDs, such as, public and private initiatives in their prevention, continuous screening, proper diagnosis, providing most effective treatment, and population’s lifestyle management for more effective disease control. However, in this article, I shall focus only on modern drug pricing, as one of the key barriers for patients’ access to modern drugs for the treatment of these ailments.

Saying something, and doing something else:

In this context, some large pharma lobby groups pontificate that the drug industry recognizes the economic and social impact of NCDs. Many of them also try to widely publicize, that they are working with various stakeholders, such as, the Governments, other payers and patients’ groups, as an active solution partner in lessening this burden. 

Yes, some of them do actively support some programs, mostly to prevent, screen and diagnose these chronic ailments. There are also instances when they try to showcase some of their occasional and complicated, so called ‘patient access’ programs.

Interestingly, a global major even wanted to reap a rich harvest by highlighting one such initiatives to win a patent litigation in the Supreme Court of India. As many would know, the Apex Court of the country did not take cognizance of its real value to patients, as projected by the concerned company, while dictating its final judgement on the Glivec case.

To many independent experts, these could most probably be part of a grand façade to justify the high drug prices, which most of the patients can’t afford, and also is an attempt to manage their fast eroding overall public image. On the other hand, they ‘religiously’ continue to keep increasing the drug prices arbitrarily, including those of NCDs. I shall dwell on it below.

Impeding patient access to modern drugs:

Despite all these developments, the issue of general affordability of most effective available drugs, even by the payers, such as, many Governments and the health insurance companies, are seriously impeding the patient access to these medicines.

Such exorbitant treatment costs with modern and more effective drugs is creating almost an impregnable barrier for access to these medicines, mostly for those patients incurring Out-of-Pocket (OoP) expenditure on health care. In a situation like this, where the volume sales do not increase significantly, to maintain the business growth the manufacturers of these drugs further hike up their product prices to a jaw dropping level, as perceived by both the patients and the payers.

This overall pricing environment is now posing a major challenge to many even in many developed countries of the world, including the United States.

Even the sky is not the limit:

Today, for a drug price increase not even the sky is the limit. Recently, the Census Bureau, Commerce Department of the United States (US) announced May 2016 sales of merchant wholesalers of various industries in the country. According to this report, the total pharma sales by manufacturers to pharmacies, hospitals, and others in the distribution chain reflected a buoyant increase of a hefty 11.3 percent from a year ago, especially when most other sectors showed sluggishness in growth.

The obvious question, therefore, that comes up, are the Americans now consuming more pharmaceutical products than in the past? The answer, however, is negative, though not very surprising to many.

In that case, is this increase in growth coming primarily from price increases of drugs, which are mostly used for the treatment of chronic ailments? The answer now will be an affirmative one. 

How much price increase is enough?

This question becomes quite relevant, when a large section of even Americans starts raising their voices against high drug price, as it is adversely impacting their access to those drugs. 

If this question is put slightly differently, such as, when Apple Inc. can take an annual price increase of around 10 percent for its iPhones in the Unites States (US), how much drug price increases the pharma companies are possibly taking every year in the same country? This interesting point was deliberated in an article published in The Wall Street Journal (WSJ) on July 14, 2016. 

Price increases driving growth:

According to this article, pharmaceutical prices in the US rose by 9.8 percent from May 2015 through May 2016. This is the second-highest increase among the 20 largest products and services tracked by the Bureau of Labor Statistics’ Producer Price Index, with investment services ranking first.

Majority of pharma companies keeps increasing prices also for a large section drugs used in the treatment of NCDs, which require almost lifelong therapy for the patients to lead a normal and meaningful life.

I am trying to give below a flavor of such drug price increases, both for NCDs and communicable diseases, quoting a few examples from the above WSJ article:

  • Biogen Inc. reported a 15 percent increase to US$ 744.3 million in US sales of its Multiple Sclerosis (MS) drug Tecfidera in the first quarter, primarily due to price increases. The local revenue for Biogen’s other biggest-selling products, Avonex, used in the relapsing form of multiple sclerosis, and Tysabri used in multiple sclerosis and Crohn’s disease, also benefited from higher prices.
  • The sales of Giliead Science’s Truvada, used as a preventive treatment for HIV rose 16 percent in the quarter, on the back of higher prices, and also increased use as a preventive treatment for HIV.
  • Global sales of Amgen Inc.’s anti-inflammatory drug Enbrel rose 24 percent in the first three months of the year, driven primarily by a higher net selling price.
  • US sales for AbbVie Inc.’s anti-inflammatory drug Humira rose 32 percent in the first quarter, due to price increases and higher prescription volume. 
  • Pfizer Inc.’s US price increases and, in some cases greater prescription volume, helped drive higher revenue for nine drugs representing US$2 billion in US revenue.

Payers have started reacting:

Responding to this development, Express Scripts’ National Preferred Formulary (NPF) of the US, which is one of the most widely used drug list in the United States, providing prescription drug coverage guidelines for 25 million Americans, has excluded many drugs from its 2017 list. This exclusion covers some brands, such as, Novo Nordisk’s blockbuster GLP-1 diabetes drug Victoza and two of its top-selling insulins.

Similarly, another large American retail and health care company CVS Health’s 2017 formulary does not feature, among many other drugs, Sanofi’s blockbuster insulin Lantus along with its follow-up Toujeo, making it the largest commercial product ever excluded from a formulary. 

‘The playbook used for a number of years is over’:

In an article of August 04, 2016 titled, “Drug lobby plans a counterattack on prices”, a senior director of the public affairs firm APCO Worldwide, which represents several drug companies, and a former HHS official under President George W. Bush was quoted saying, in the context of pharma companies and their lobby groups that, the reality, the message and the playbook used for a number of years is over. The industry can no longer defend high drug prices by pointing to the pricey research and development that goes into innovative medicines. They have to move on, he added.

Indian scenario:

The Indian scenario is much worse, with OoP expenditure on drugs being around 70 percent of the total treatment cost. It could be even more, if only NCDs are considered. This situation raises a red flag, especially considering the WHO report released on January 20, 2015 that highlights NCDs are estimated to have accounted for 60 per cent of the deaths in India in 2014.

Some of the examples are as follows:

  • An ICMR-INDAIB study, published in September 2011, on diabetes prevalence in India indicate that the epidemic is progressing rapidly across the nation, and has already affected a total of 62.4 million persons in 2011. With proper diagnosis and screening this figure may increase to a dangerous level in India.
  • According to WHO, almost 2.6 million Indians are predicted to die due to coronary heart disease (CHD), which constitutes 54.1 percent of all CVD deaths in India by 2020. 
  • A March 2012 ‘The Lancet’ study found that nearly six lakh Indians die of cancer every year, with 70 percent of these deaths between the ages of 30-69 years.
  • A report titled “Dementia in Asia Pacific Region” released in November 2014, at the 17th Asia Pacific Regional Conference of Alzheimer’s Disease International (ADI) states that by 2050, the number of people in India suffering from dementia will rise to over 12 million.

Carefully assessing the enormous pharma business opportunity, mainly due to increasing health awareness and fast growing per capita income in the country, pharma players operating in India have become very active in the NCD area, in different ways. However, one strategy remains unchanged, which is continuous increase in modern drug prices, even at the cost of volume increase, frequently taking them beyond affordability of a large section of patients in India. 

Indian Government also reacted:

Recognizing, and basically to address this critical problem, just as what has is now happening in other parts of the globe too, the Union Ministry of Health was compelled to take strong measures, especially in the absence of Universal Health Care (UHC) in India. The Government recently revised the National List of Essential Medicines (NLEM) by adding many more modern drugs for NCDs in the list, to facilitate bringing them under the drug price control mechanism of the country.

Many company’s evading drug price control:

The Union Chemicals and Fertilizers minister Mr. Ananth Kumar informed the Rajya Sabha of the Indian Parliament on July 28, 2016 that various drug price regulatory measures taken by the government have helped consumers save Rs 4,988 crore over the last two years.

This saving may well be just on the paper. On the ground, have the consumers been really benefited out of these measures, and if so, to that much extent? 

The answer wouldn’t be too ferret out, when one takes into account the reply of the Minister of State for Chemicals and Fertilizers, Mr. Hansraj Gangaram Ahir to the Lok Sabha of the Parliament on March 08, 2016. The Minister informed the lawmakers that the National Pharmaceutical Pricing Authority (NPPA) is trying to recover a whopping Rs 4,551 crore, including interest, from various pharma companies for overcharging as of February 2016. Out of this total amount, Rs 3,698.32 crore, representing about 82 per cent of the total outstanding amount, is under litigation in various High Courts and Supreme Court spreading across 1,389 cases, the Minister further said.

The question, therefore, arises, how much benefit of the drug price control of essential medicines is actually benefitting the patients, and how much is being evaded by the pharma players?

Price increases driving Indian pharma industry growth:

In India too, a large number of pharma companies are increasing prices, including a large proportion of those drugs, which are used in the treatment of NCDs, requiring almost lifelong therapy for the sufferers to lead a normal and meaningful life.

The exorbitant treatment cost for many NCDs, with the modern and more effective drugs, is seriously impeding the patient access. As a cascading effect, the manufacturers of these drugs are further jacking up their prices to a much higher level for achieving their business growth objectives. This is very similar to what is happening also in the developed countries, including the US. 

That price increases are primarily driving the growth of the Indian Pharmaceutical Market (IPM) is vindicated by the following table, which has been compiled from the monthly retail audit reports of the well-reputed organization AIOCD Pharmasofttech AWACS Private Limited:

IPM growth through price increases versus volume (July 2015 to June 2016):

Growth % Jun 16 May April Mar Feb Jan 16 Dec 15 Nov Oct Sept Aug July 15
Price 3.8 5.0 4.5 5.1 5.4 5.1 5.2 1.0 13.2 9.9 13.2 12.9
Volume -0.6 -4.4 3.2 -5.3 3.7 1.3 2.8 5.0 5.5 1.4 1.6 3.3

Source: Monthly Retail Audit of AIOCD Pharmasofttech AWACS Pvt. Ltd

Conclusion:

Around the world, arbitrary drug price increases almost on a continuous basis, including in the low inflation countries that may now include India, has sparked-off a raging global debate. Even the Presidential nominees for the forthcoming general election in the United States are taking keen interest on the subject.

As highlighted in a recent issue of the magazine Politico, powerful pharma lobby groups are also gearing up to spend hundreds of millions of dollars to counter this ‘threat’, as perceived by them.

A number of hectic activities in this area, apparently, have started in India too, mainly to divert the focus of the stakeholders from arbitrary drug price increases to other important areas such as, NCDs. This usually happens by making the vested interests eulogizing how much good work these pharma companies are doing in this particular area, only to serve the patients’ health interest. 

Many global pharma players seem to still believe that the same old message from the same old playbook would work even today, at least in India, to defend high drug prices on the contentious ground of pricey R&D that goes into innovative medicines. I reckon, almost gone are those days, even in India.

NCDs need to be fought, unitedly, with effective public, private initiatives and without any self-serving agenda of any participants. The issue needs to deliberated not in the five-star hotels, neither in front of a captive audience, nor with an intent of getting favorable media coverage, but on the real ground, along the general population, both in the urban and the hinterlands of India.

These initiatives would appear praiseworthy to many, when the ultimate aim of any stakeholder, including the doctors and the pharma players, won’t be to make the consumers consume more of high priced medicines, in many cases even by selling their frugal assets. The key aim, I believe, should be to facilitate prevention, screening, diagnosis and treatment with affordable modern medicines, and finally to help manage the ailments well, through the rest of the life of any sufferers.

In the battle against NCDs, it is also important to know well and segregate, if there is any wolf around, in sheep’s clothing.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Arbitrary Pricing of Essential Drugs Invites State Intervention

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Arbitrary drug pricing has now become a subject of a raging debate, all over the globe. It involves both patented and generic drugs, as we have recently witnessed in the largest pharma market in the world – the United States.

In many countries the same issue is inviting the direct intervention of the Government to protect health interest of a vast majority of the populations. India, I reckon, belongs to this group of countries. 

In this article, I shall discuss this issue, citing examples from both the global and local recent developments.

Most high drug price increases defy logic: 

Published in March 2016, the ‘Express Scripts 2015 Drug Trend Report’ points out, in the perspective of the United States, that over the last 30 years more and more dollars are spent on specialty, rather than on traditional medications.

Most drug development and spend in the late ‘80s and early ‘90s, used to be on traditional, mostly small-molecule oral solid drugs, used to treat conditions, such as, peptic ulcer, depression, hypertension and diabetes. Today, 37.7 percent of drug spends go for specialty medications, with the number expected to increase to 50 percent by 2018, and continue to grow further, thereafter. 

The report also states that there are 7,000 potential drugs in development, with most aimed at treating the high-use categories of oncology, neurologic disorders and infectious diseases.

High-cost therapies for non-orphan conditions, particularly for cancer, high cholesterol and Alzheimer’s disease, will continue to increase the population of patients with high annual drug expenditures.

‘Express Scripts Exclusive Prescription Price Index’ reveals a brand-price inflation in the United States, nearly doubled between 2011 and 2015, with the greatest impact seen in more recent years. Compared to 2014, brand prices in 2015 were 16 percent higher. Brand medications have increased in price by 164 percent between 2008 and 2015, the report highlighted.

Similar trend, though may not be of similar magnitude and proportion, has commenced in India too. In this emerging situation, the patients with high ‘out of pocket’ expenditure on medicines have started feeling the pinch too. This is becoming more intense as the disease pattern has started shifting from short-term infectious and parasitic diseases to almost lifelong non-infectious chronic ailments.

The pressure started building up:

The drug industry is likely to come under increasing scrutiny on product pricing, to alleviate the ‘pressure cooker’ situation for the patients, in general, especially during chronic and life-threatening disease conditions. 

May 10, 2016 issue of ‘Bloomberg’, in an article titled, “Mutual Fund Industry to Drug makers: Stand Up and Defend Yourself”, reported: “In a sign of how U.S. political pressure to rein in drug pricing is weighing on pharmaceutical companies and their investors, a group of major funds called an unusual meeting with top biotech and pharma lobbyists, urging them to do a better job defending their industry.” This is indeed unusual, and I reckon, should happen in India too. 

The article also states: “Investors are stepping up pressure on pharma lobbyists at a critical time for the industry, as drug pricing has become a potent political issue on the presidential campaign trail and in Congress. Democratic candidate Hillary Clinton sent biotech stocks tumbling last year when she first talked about ‘price gouging,’ and Donald Trump has suggested that Medicare should negotiate with manufacturers.”  

It also reported that responding to this emerging pressure situation, the global pharmaceutical lobbying organizations, such as, PhRMA in the Washington, DC has already set up a dedicated webpage called “Costs in Context” with infographics and fact sheets. It has also tried to peg responsibility on insurance companies for making it hard for patients to access medicines. 

Patients’ can no longer be taken for granted:

That patients’ can no longer be taken for granted with costly drugs, backed by high profile marketing campaigns, is evident from a recent study.

In May 2016, Harvard T.H. Chan School of Public Health, published a poll result on “Americans’ Attitudes About Changing Current Prescription Drug & Medical Device Regulation”. 

Among many other related issues, the study reflected that around 57 percent of the poll participants believe that pharmaceutical companies should no longer be allowed to advertise prescription drugs on television. This is because of interesting reasons. The respondents believe that ads for prescription medicines sometimes encourage and persuade the patients to ask for costlier drugs that may not be appropriate for them. 

In this context, it is worth recapitulating that on November 17, 2015 the American Medical Association (AMA) also called for a ban on direct-to-consumer advertising of prescription drugs and medical devices, including television advertisements. 

According to a statement released by the group, “member physicians are concerned about a growing proliferation of ads driving demand for expensive treatments, despite the clinical effectiveness of less costly alternatives.” 

Hence, the bottom-line is, even the American patients, most of whom are covered by health insurance of different kinds, are now feeling the bite of increasing medicine prices.

Many patients seem to be realizing that such unfair price increases, driven by the respective pharma manufacturers, are avoidable. This serious concern may assume a snowballing effect, notwithstanding high voltage lobbying and campaigns to negate these general stakeholders’ feelings by the top global pharma lobbying organizations, across the world, India included.

Premium pricing of MNCs’ branded generics arbitrary?

One gets its reflection even in the Indian branded generic market, where the MNCs usually market their generic single molecule or FDC brands at a huge premium price. Such high priced products are backed by intense marketing of all kinds. The MNCs’ justification of charging a high premium stand on the promise of adherence to world-class drug quality standards, unlike many domestic generic manufacturers.

There are not enough evidences either to accept or ignore this claim. However, it has received a big jolt even recently, raising similar suspicion as I briefly raised in my article titled, “Ease of Doing Pharma Business in India: A Kaleidoscopic View”, published in this blog on March 28, 2016. 

On May 12, 2016 Reuters reported that Central Drugs Standard Control Organization (CDSCO) of India, in the notices posted on its website in February and also in April, has made it public that it has found some batches of Sanofi’s ‘Combiflam’ (FDC of paracetamol and ibuprofen) to be “not of standard quality”, as they failed disintegration tests. 

According to the US-FDA, this particular test is used as an integral part of quality-assurance measure in pharmaceuticals, and its non-conformance makes the drug ‘sub-standard’. 

Hence, huge premium charged for all those branded generics, which are outside DPCO, and mostly by the MNCs, may be construed by many as baseless and arbitrary.

Premium pricing, with payment to doctors is a winner?

This has again been vindicated in a recent study.

A paper, published in the May 09, 2016 issue of JAMA Internal Medicine, establishes that: ‘Pharmaceutical industry payments to physicians may affect prescribing practices and increase costs, if more expensive medications are prescribed.’

Although no such credible study has been published in the Indian context, it is widely believed, the prevailing situation in this regard, within the country, is no different. Nevertheless, arbitrarily high drug pricing, even for the branded generics, is considered as a winning strategy by many pharma companies. 

When the Government steps in:

It happened in India recently, yet again.

As we know, the ‘National List of Essential Medicines 2011 (NLEM 2011)’ came under intense public criticism, as it did not include many modern drugs for chronic and lifesaving diseases under its fold, for inclusion in the drug price control order of the Government.

The Experts Committee formed for this purpose recommended addition of a number of drugs for a variety of serious diseases, such as, cancer, hepatitis C, diabetes, cardiovascular, and HIV in the NLEM, to make them more affordable to patients. 

Acting on this proposal, the Union Ministry of Health replaced the NLEM 2011 by NLEM 2015 in December 2015. This increased the span of drug price control from 684 to 875 medicines.

According to the well-reputed pharma market research organization – AIOCD Pharmasofttech AWACS Pvt Ltd., with NLEM 2015, still only 18 percent of Indian Pharmaceutical Market (IPM) by value will now come under price control, against 17 percent with NLEM 2011. 

On May 12, 2016 the ‘National Pharmaceutical Pricing Authority (NPPA)’ started with revising prices of 54 recently included essential medicines in the NLEM 2015, in some cases bringing them down up to 55 percent, in conformance with the DPCO. Again on May 19, 2016 another set of 27 formulations,  which, among others, include the treatment for epilepsy, infections and diabetes, were brought under price control.

Does ‘free market economy’ work in pharma industry?

As the NPPA has articulated a number of times, with umpteen number of examples, that arbitrary and wide variation in pricing for the same kind of branded generics is a result of ‘market failure’.

We all are living in a unique situation, where the consumers are unable to participate in the process of an affordable drug selection, much unlike any other consumer goods in a ‘free economy’. 

I deliberated this issue in my article titled, “Does ‘Free-Market Economy’ Work For Branded Generic Drugs In India?”, published in this Blog on April 27, 2015.

Conclusion: 

Arbitrary drug pricing is increasingly attracting the ire of many Governments, other payers, patients and even some important investors, as we have seen in the United States. Most Indian fund houses and other investors are probably taking stock of the possible emerging situation. A large number of them are, by and large, going by the same old and traditional way of evaluating a pharma business.                                                                                 

Pharma companies, across the world, instead of trying to find out an innovative way to douse this fire for the benefit of all concerned, are getting more and more desperate to rationalize their arbitrary drug pricing, in whatever way they possibly can.

The approach taken by them is convincing none, instead, adding further fuel to the fire. Getting favorable views from some handful of seemingly spoon-fed write-ups, would possibly not help resolve this raging issue or protect public health interest, in any way. 

All concerned should try to realize that a utopian ‘free market economy for medicines’, with patients exercising their informed choices, backed by active support from the treating doctor, does not exist in the real world, not just yet. 

Thus, arbitrary pricing for essential drugs, where market competition is made irrelevant by many drug makers, allegedly by unethically influencing the prescribers in various ways, merits state intervention, unquestionably, solely to protect patients’ health interest.

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

How Expensive Is Drug Innovation?

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High prices for patented drugs are quite often attributed to the exorbitant cost of drug innovation, by the global pharma players. This argument is played, replayed again, again… and again by them, in various ways and forms, especially when many eyebrows are raised, failing to fathom the primary reason for ever escalating prices of life-saving new drugs.       

I find the same argument often getting echoed by some section of both the global and local media too, and also through some cleverly disguised and apparently sponsored articles on the subject. 

In this article I shall dwell on this sensitive issue.

A strong justification: 

The Institute for Policy Innovation (IPI) based in Texas in the United States, in an article titled “The High Cost of Inventing New Drugs–And of Not Inventing Them”, published on April 16, 2015 reiterated that the financial cost of developing new drugs is indeed a big one.

It argues that “there is also a big cost to not developing new drugs, and that cost can be both financial and human. People may be able to live with the pain that an undiscovered drug might have alleviated, but they may not be able to do all the things they would have.”

The paper asks, “A cancer patient might still have a few productive years after a diagnosis, but how much would it be worth to the patient—and to society (think Steve Jobs), if a new drug could extend a patient’s life indefinitely?”

“The drug manufacturers poured money into finding a treatment for AIDS once it became clear the disease would take thousands of lives. The research and development was costly and didn’t emerge overnight, but being diagnosed with AIDS is no longer a death sentence,” the authors elucidated.

This is a very cogent argument, and nobody would dispute it. This issue lies somewhere else, as I would try to explore in this article.

The supporting data: 

We also find supporting published data to justify the high cost of innovation with numbers.

On November 18, 2014, a new study by the ‘Tufts Center for the Study of Drug Development’ highlighted that developing a new prescription medicine and gaining its marketing approval, which is a process often lasting longer than a decade, is estimated to cost US$ 2,558 million.” This number is indeed mind boggling by any yardstick.

While many details of the study remain a secret, only slightly more than half of this cost is directly related to research and development (R&D). For example, US$ 1.2 billion are “time costs” – returns that investors might have made if their money wasn’t tied up in developing a particular drug.

Not many takers:

Besides the above reason, for several other factors, there does not seem to be many takers for this exorbitant cost of innovation and bringing a new drug to the market.

The above study has become a contentious one and has, therefore, been challenged by many experts. I would give here just one example, out of many, from a highly credible source.

May 14, 2015 issue of ‘The New England Journal of Medicine’ questioned the methods used to generate the US $ 2.6 billion figure and raised the following interesting points in the above Tufts Center study: 

  • The analysis was based on data that 10 unnamed drug makers provided on 106 unnamed investigational compounds that they had “self-originated.”
  • The raw numbers on which the analysis is based are not available for transparent review, and are likely never to be divulged. 
  • Since a balanced assessment would have to take into account the costs of failures as well as successes, it is hard to evaluate the key assumption that more than 80 percent of new compounds are abandoned at some point during their development, which is a key driver of the findings.
  • Nearly half the total cost of developing a new drug (US$ 1.2 billion) was ascribed to this cost of capital, with only US$ 1.4 billion attributed to the funds actually spent on research. These capital costs were assessed at 10.6 percent per year, compounded, despite the fact that bonds issued by drug companies often pay only 1 to 5 percent.
  • In terms of access to capital, it’s interesting to note that large drug makers are among the U.S. firms with the highest amounts of profits held overseas. Two pharmaceutical companies are ranked third and fourth among all the U.S. corporations in this regard: Pfizer (US$ 69 billion) and Merck (US$ 57 billion), respectively. Collectively, another eight drug companies reportedly have an additional US$ 173 billion of capital that is retained overseas, untaxed by the United States. Such funds could potentially help with the cash-flow problem that plays such a large role in these estimated costs of drug development.
  • The Tufts calculations also explicitly do not take into account the large public subsidies provided to pharmaceutical companies in the form of research-and-development tax credits or substantial payments received from the federal government for other research activities, such as testing their products in children. 
  • The US$ 2.6 billion figure does not consider drug-development costs borne by the public for the large number of medications that are based on external research that elucidated the disease mechanisms they address.
  • One recent analysis showed that more than half of the most transformative drugs developed in recent decades had their origins in publicly funded research at nonprofit, university-affiliated centers.
High innovation cost fails to justify high drug prices:

That even the high cost of innovation fails to justify high drug prices, was also echoed in an article published in ‘The New York Times’ on December 19, 2015.

The article categorically said, ‘there is ample evidence that drug prices have been pushed to astronomical heights for no reason other than the desire of drug makers to maximize profits. Prices in many cases far exceed what’s needed to cover the costs of research and clinical trials, and some companies have found ways to rake in profits even without shouldering the cost of drug development.’

Yet another justification of high new drug prices:

Yet another justification of a slightly different kind also frequently comes from the global pharma players for high prices of new drugs.

On May 2, 2015 ‘The Washington Post’ also published an article, which recapitulated this oft repeated justifications for keeping the prices of new drugs high, especially those for rare diseases, including many types of cancer. The key rationale of this argument: the smaller is the number of patients who need the drugs, more would be the need of the company to price the drugs high to recoup the significant costs of drug development.

On the face of it, this justification too may sound convincing. However, on the ground, even if this argument of the global drug companies fails to stand on its feet, post robust scrutiny of the experts. In that context, I shall cite two recent examples.

Two new research studies broke this myth too:

The Following two April 2016 study conclusively demolishes the above justification of the global drug companies:

1. On April 28 2016, a new study was published in  JAMA Oncology, throwing  a great deal of light on the robustness of the above reasoning. In this paper, the researchers looked at 32 oral cancer medications and found that launch prices of these drugs have spiraled upward, even after adjusting for inflation. The average monthly amount insurers and patients paid for a new cancer drug was less than US$ 2,000 in the year 2000, but it skyrocketed to US$ 11,325 in 2014. 

2. In April 2016, another study published in Health Affairs found, when a drug became useful to a larger number of patients, the price also shot up. It, therefore, concluded as follows:            

“Our findings suggest that there is currently little competitive pressure in the oral anticancer drug market. Policy makers who wish to reduce the costs of anticancer drugs should consider implementing policies that affect prices not only at launch but also later.”              

Are high new drug prices, then arbitrary?

According to a July 2015 article published in JAMA Oncology, the high prices of new drugs, especially for cancer, are arbitrary. This is vindicated in the discussion of the article that clearly states, as follows: 

“Cancer drug prices are rising faster than the prices in other sectors of health care, drawing concern from patients, physicians, and policy researchers. We found little difference in the median wholesale price of 21 novel drugs and 30 next-in-class drugs approved over a 5-year period (next-in-class drugs, $119 765; novel drugs, $116 100; P = .42).”

“Our results suggest that the price of cancer drugs is independent of novelty. Additionally, we found little difference in price among drugs approved based on time-to-event end points and drugs approved on the basis of RR (disease Response Rate). Our results suggest that current pricing models are not rational, but simply reflect what the market will bear.” 

Thus, the derived fact is, the high prices of new drugs are neither dependent on high cost of drug innovation, nor on the number of drug users – high or low. Higher drug prices, therefore, appear to be nothing but arbitrary, the public justifications being no more than façades. 

Is the real cost of drug innovation much less?

This question brings me back to the moot point, ‘What is then the real financial cost of drug innovation?’

The search for a generally acceptable answer to this question gets even more complicated, when one reads the paper of The Bureau of Economics, Federal Trade Commission’ in Washington, DC, published on March 7, 2006 in Health Affairs – the leading journal of health policy thought and research.

The paper estimates the cost per new drug to be US US$ 868 million. However, it says, “Our estimates vary from around US$ 500 million to more than US$ 2,000 million, depending on the therapy or the developing firm. The paper recommended that variations in cost estimates suggest that policymakers should not use a single number to characterize drug costs.

Conclusion:

This situation arises, because the drugs with brand names, whether patented or off-patent, do not compete on price in the pharma market, across the world. The primary reason being a consumer is neither the prescription decision makers nor can they exercise their brand choice in any manner. For any patients, a doctor always takes this decision, who is often influenced by the drug manufacturers, and may not be even aware of the drug price, as is generally alleged, globally.

This process is quite unlike to any other essential commodities. However, the ongoing marketing campaigns for branded drugs are quite a keen to commonly used consumer goods, carrying brand names and backed by high profile branding campaigns, where high prices rather add greater perceived value to the brand status.

But the irony is glaring. The administration of life-saving highly expensive drugs is not optional for any patient, whether poor or rich. These are necessary to save lives. Thus, does not merit arbitrary high-profit driven pricing, at least, from the standpoint of patient-centric ethical business practices.

It still happens, even at the cost of access to such drugs by a large majority of the global population, who requires them the most. In all probability, this process is likely to continue in the near future too, irrespective of the quest of many to fathom how expensive is the drug innovation, unless the government or other payers actively intervenes. I shall discuss this issue in my next article in this Blog. 

Nevertheless, the answer to the crucial question, ‘How expensive is the drug innovation’ would continue to remain elusive to many, at least in the near term. This because, no global drug company is likely to allow any competent and independent experts group to arrive at this number in a transparent manner, which can also be peer reviewed. Nor would the pharma players, in all probability, furnish this information to any Government to justify the high price of their respective new brands.

Till this is done, pricing decisions of new lifesaving drugs would continue to remain arbitrary, primarily driven by high-profit motives. It is unlikely to have even a remote direct linkage to the cost of drug innovation, limited consumer access notwithstanding, just as what happens with many branded consumer goods.

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Democratization of Healthcare: An Evolving Trend Driven By Cutting-Edge Technology

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We have stepped on to a fascinating era of yet another disruptive innovation in a newly carved out space of the healthcare domain.

Such initiatives are driven by path breaking ideas, which are being translated into reality with the application of cutting-edge technology. All these are aimed at providing a plethora of unique healthcare related solutions in the cyberspace to various stakeholders, especially to patients through inexpensive smartphones of various types.

Although the process has just begun, but is moving at a rapid pace. In virtually no time, as it were, it is showing a great potential of delivering more accurate and affordable healthcare solutions to a large number of the population globally, particularly in the developing nations.

‘Democratization of Healthcare’: 

The ‘patient empowerment’ of such kind, with technology enabled the power of personalized healthcare knowledge and information in an organized manner, has been termed as ‘The Democratization of Healthcare.’

The critical point to ponder, therefore, whether this fast developing state of art technological advancement has the potential of delivering a novel and much affordable process of disease treatment and management, in the real world. As it happens, the new paradigm would shift the focus of key stakeholders from doctors to patients, in a genuine sense, and almost irreversibly.

In this article, I shall deliberate on this wonderful emerging scenario.

A recent reiteration raises hope:

The following reiteration of one of the largest and most reputed tech giant of the world raises general hope that this process would soon come to fruition:

‘The democratization potential of healthcare interests most of us, as the injustice of fantastic healthcare available in some parts of the world, and others suffering needlessly.”

The above profound comment was made on a radio show – ‘Conversations on Health Care’, by none other than the Chief Operating Officer, Jeff Williams of Apple Inc. on January 4, 2016 and was reported accordingly by ‘appleinsider.com’ on January 06, 2016.

Jeff Williams also indicated in his talk, how smartphone technology can be harnessed for therapeutic purpose in disease treatment, as well. Citing an example, he said, detecting autism at an early age is a key to future treatment, as doctors can intervene – albeit to a limited degree – as long as the brain is still developing. 

He referred to a study that found not just the potential in app-based smartphone screening of children, but can even go much further by delivering therapy and treatment.

The rapid progress of technology in this direction is very real, as ‘Apple’ and other smartphone health app developers are stretching the commoditization of computer technology to serve health sciences. In not so distant future, with relatively inexpensive smartphones and supporting health apps – the doctors and researchers can deliver better standards of living in severely under-served areas like Africa, where there are only 55 trained specialists in autism, Williams said.

Triggers a key shift in focus: 

As I said before, unleashing the power of technology in healthcare solutions through smartphones will bring a fundamental shift in focus of all concerned, from medical doctors to ordinary patients. 

This transformation seems to be rather imminent now, as equipped with detailed knowledge of various types of individual health and disease related information through their smartphones, the patients would position themselves in the driver’s seat, demanding more for affordable treatment of diseases. 

Dr. Eric Topol, the author of the book titled, “The Patient Will See You Now”, thus very appropriately said, “MDs will no longer be considered ‘medical deities’, but rather professionals with whom patients will consult to get the proper treatment on the path of least resistance.” 

Consequently, the pharma players and other related service providers would require to ‘walk the talk’ by being ‘patient centric’ in the true sense, and definitely not by using this profound term, as one of the tools of their mostly self-serving, advocacy campaigns.

Empowering patients:

As Dr. Eric Topol said, smartphone applications that can monitor throughout the day, such as, heart rate and rhythm, blood pressure, take and interpret an electrocardiogram, capture X-rays and analyze ultrasound, have the potential to reduce patient visits to doctors, cut costs, speed up the pace of care and give more power to patients. He emphasized though, digital apps won’t replace physicians. The patients would still be seeing doctors, but the doctor-patient relationship will ultimately be radically altered.

As an illustration, it is worth mentioning here, that taking a significant step forward in this direction, the U.S. Food and Drug Administration (USFDA) has already approved ECG apps by for consumers, which have been validated in many clinical studies.

Examples of Smartphone Apps for patients:

Smartphone apps are now available for different user segments. In this section, I shall focus only on patient-centered apps capable of performing a wide array of functions, such as managing chronic disease, lifestyle management, smoking cessation and even self-diagnosis.

I am quoting below just a few of these interesting apps, as reported in an article published by ‘The Online Journal of Public Health Informatics (OJPHI)’ on February 5, 2014:

A. For diabetic patients, over 80 apps on the Android platform alone, offer a variety of functions. These include self-monitoring blood glucose recording, medication or insulin logs, and prandial insulin dose calculators.

Yet another diabetes intervention app integrated communication between patients and a healthcare provider. Here, the patient would log fasting blood sugars, daily eating behaviors, medication compliance, physical activity and emotions into a mobile online diary. A remote therapist with access to these diaries would then formulate personalized feedback to the patient.

‘WellDoc’ is reportedly one such company that has already received approval of the US FDA for its mobile-enabled diabetes management program, and is being paid for by health insurers as they would for a pharmaceutical product.

B. For smoking cessation and alcohol addiction apps are also available. At least 47 iPhone apps for smoking cessation and another one called – ‘A-CHESS’ (Alcohol Comprehensive Health Enhancement Support System) helps preventing relapse in alcoholic dependency and harnesses mobile technology to improve treatment and motivation.

C. For asthma and allergic rhinitis patients, an app called ‘m.Carat’, developed at Faculdade de Medicina da Universidade do Porto, Portugal, , helps recording their exacerbations, triggers, symptoms, medications, lung function tests and visits to the doctor or the hospital. The users of this app can also receive disease education, medication information, task notifications, and synchronize records with an online database to better control their symptoms.

D. For psychiatric patients, available smartphone apps offer benefits of ambulatory monitoring, that randomly prompts the patient to self-report psychotic symptoms multiple times throughout the day.

E. For sickle cell disease another app allows patients access to an online diary for recording pain and other symptoms.

F. For patients with dementia, ‘iWander’ app assists the affected individuals with daily living, by providing audible prompts to direct the patient home, sending notifications and GPS coordinates to caretakers, or by calling local 911 (US emergency) services.

G. For HIV (human immunodeficiency virus) and STD around 55 unique smartphone apps are available. These are used for education, prevention, testing and to provide other resources.

Self-diagnosis without a medical visit:

The above article also states that patients may even use smartphone apps to attempt self-diagnosis without a medical visit. Patients with a camera-enabled smartphone can use apps to take photographs of skin lesions and send these to a remote server for computer analysis and/or review by a board certified dermatologist. However, such apps are still not without their pitfalls, which are being addressed by the scientists, expeditiously.

Nevertheless, informed debate has already started in search of an appropriate direction for self-diagnosis with the help of robust smartphone apps, without any in-person medical visits.

Need for ‘Regulatory control’ and ‘certification’ of health apps:

I hasten to add, all such smartphone health apps should not be allowed to come to the market without stringent regulatory control and a well thought out the certification process.

As in the United States, where the health apps are being assessed by the U.S. Food and Drug Administration (US FDA), in India too the Drug Controller General of India (DCGI) or any other appropriate and designated authority should approve and certify all such smartphone health apps, before the market launch.

‘Trust deficit’ poses a critical challenge to pharma industry:

Since the health apps opportunity is new, and still in its evolutionary stage, pharma industry, in general, does not seem to have fully accepted yet, that the process of ‘Democratization of Healthcare’ has already commenced. I reckon, the progress in this direction is unstoppable now. Nevertheless, many drug companies apparently continue to prefer sticking to the same proven path that had fetched enormous success for them in the past and, of course, also its associated business models.

Besides health apps, the democratization process of healthcare includes other technological platforms too, such as, social media and video communications, which have started to bring healthcare into patients’ homes. To be successful in a situation like this, gaining ‘patient trust’ has become more important today than ever before, for all concerned. 

Unfortunately, the drug companies, generally speaking, continue suffering from an increasing ‘trust deficit’ of the key stakeholders. This has been vindicated by a September 9, 2013 study of Makovsky Health, which found:

  • Pharma websites continued to rank low in terms of traffic, with just 9 percent of Americans visit them for health information.
  • WebMD is the most frequented online source for healthcare information (53 percent)
  • Almost a fourth of consumers (24 percent) use at least one or a combination of social media channels – including YouTube video channels, Facebook sites, blogs, and Twitter feeds with links to other resources – to seek healthcare information  

The writing on the wall:

Some major global pharma players apparently have clearly seen the writing on the wall, and started collaborating with the developers of various types of digital health apps.

Quoting from the May 02, 2014 edition of ‘MobileHealthNews”, I am citing below, just as an illustration, the initiatives taken in this space by some of the drug majors: 

Pfizer (2014) had backed startup Akili in the development of a mobile game to help diagnose patients with Alzheimer’s. The game could also be used in the treatment or detection of ADHD and autism, among other conditions.

Johnson & Johnson’s subsidiary, Janssen Healthcare Innovations (2013), launched the new version of its free Care4Today medication reminder app and platform – Care4Today Mobile Health Manager 2.0. It has also overhauled Care4Today medication adherence app.

Sanofi US (2013) and the Prostate Cancer Foundation announced the creation of Prost8Care, an SMS system to help prostate cancer patients and their families understand treatment processes.

AstraZeneca (2013) announced a pilot with Exco InTouch to help patients suffering from Chronic Obstructive Pulmonary Disease (COPD), with mobile and online tools. 

Sanofi’s (2012) iBGStar device became the first US FDA cleared iPhone-enabled blood glucose meter.

GlaxoSmithKline (2012) offered a free asthma management app called MyAsthma, for iPhone and Android users. The app’s core offering is an Asthma Control Test (ACT), which is a simple 30-second test providing users with an index score of how well they are managing their asthma overall.

The potential in India:

In India, ‘Democratization of Healthcare’ is believed to be more broad based, with a third of all Indian mobile users expected to own a smartphone by 2017.

This is vindicated by the Press Release of Telecom Regulator TRAI, India, pharma, drug, playersy Authority of India (TRAI) of December 30, 2015. It states, the Wireless Tele-density in India is 79.39 as on October 31, 2015. The shares of urban and rural wireless subscribers were 57.61 percent and 42.39 percent, respectively, during the same period.

Conclusion:

The process of ‘Democratization of Healthcare’ is gaining momentum with the digital health app developers flooring the gas pedal. Even the global tech giant – Apple, has expressed its support and vow of taking rapid strides in this direction.

As this fascinating process unfolds, the final disease treatment decision, from various medical options available, is expected shift from doctors to patients, and may be their closest relatives. In tandem, patients would learn to take ownership of their physical and mental health conditions for disease prevention of various types, besides general fitness.

The patients, empowered with relevant digital information and knowledge, on their health status, including the pace of disease progression, would play a pivotal role not just in reducing disease burden, but also in making overall cost of individual healthcare more affordable. Additionally, access to healthcare, especially in the developing world like India and in its hinterland, will be improved significantly.

Digital apps are not just limited to patients’ use, these are being developed with equal speed for doctors, diagnostic centers, and clinical trials, just to name a few. All these would substantially reduce healthcare costs and add speed to various disease treatments.

In this golden pathway, there are some thorns too, mostly in the form of important regulatory issues, which need to be sorted out, expeditiously. Increasing ‘Trust Deficit’ of stakeholders on the drug companies is yet another hurdle, especially when the primary focus of all would shift from doctors to patients. However, it appears, the pharma players will eventually have no other choice, but to willy-nilly mold themselves accordingly, primarily for survival and thereafter progress.   

As I see it today, the fast evolving trend of ‘Democratization of Healthcare’, driven by cutting-edge technology, is virtually unstoppable now. The only question is how soon will it happen?                                                                          

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.