Why And How To Be In-Sync With Gen Z As Pharma Paradigm Shifts?

As science and technology, across the world, are progressing at a scorching pace – Covid-19 pandemic notwithstanding, today’s generations are growing up tech savvy – more than ever before. The trend will keep going north faster and with a steeper gradient. This is being driven by transforming social and economic environments – necessitating quicker solutions to any needs, problems, and expectations.

The current signals, as underscored by an article appeared in the Abbott Website on November 19, 2019: ‘Generation Z’s relationship with technology will also influence how the group relates to healthcare.’ Thus, it’s no secret that millennials approach their health care in drastically different ways than members of the Silent Generation, baby boomers or Gen Z, the article added.

Which is why, gradually shifting paradigm of the pharma industry would also eventually create a brand new one – with the Gen Z population growing at a faster pace. From the above perspective, in today’s article, I shall focus on the importance of this shifting paradigm, especially from the pharma industry perspective, including India.

Expectations and experience of Gen Z are contrasting:

Let me start with the definition of Gen Z. In January 2019, Pew Research defined Gen Z as anyone born after1996, just as ‘anyone born between 1981 and 1996 (ages 23 to 38 in 2019) is considered a Millennial.’ Gen Z grew up with technology, the internet, and social media. Moreover, according to another study of Pew Research, published on May 14, 2020, Gen Z is growing up having experienced catastrophic disruptions in almost all spheres of life and livelihoods, triggered by Covid-19 pandemic. It further ascertained, ‘the oldest Gen Zers have been particularly hard hit in the early weeks and months of the Coronavirus crisis.’

Thus, I reckon, the experience and expectations of many of such Gen Z from business and overall environment around – are quite different from earlier generations. More importantly, they will also have a strong influence on younger ones. Hence, the expected transformation would be much broader than what is currently visible today on the ground.

Some core characteristics of Gen X from pharma business perspective:

Various studies have captured the core characteristics of Gen Z, some of which are very relevant to pharma industry and are worth taking note of – for excellence in business performance. These include the followings:

Digital natives:

As McKinsey & Company highlighted in an article, published on November 12, 2018 that Gen Z is the first generation of true digital natives, and they are expanding. Whereas Millennials were regarded as ‘digital pioneers,’ who bore wit­ness to the explo­sion of tech­nol­o­gy and social media, Gen Z populations are born into a world of peak tech­no­log­i­cal inno­va­tion. In that environment infor­ma­tion is imme­di­ate­ly acces­si­ble and social media becoming increas­ing­ly ubiquitous – endorses another study by the Casey Foundation with its own findings on the core characteristics of Gen Z.

Financial minded:

Finan­cial mind­ed­ness is anoth­er core char­ac­ter­is­tic of Gen­er­a­tion Z for several reasons. A major one being, as discussed – many of them grew up witnessing unprecedented impact on lives and livelihoods caused by Covid-19 pandemic. Several other studies, like the one published recently by the Harvard Pilgrim Healthcare, indicates that millennials and Gen Z are especially sensitive to healthcare costs.

Shrewd consumers and cost-value conscious:

Gen Z show characteristics of shrewd consumers and are also cost-value conscious. Being tech savvy, they are more influenced by fast-expanding digital, world and would like to make well-informed purchasing decisions after evaluating a range of options – both for products and services. They tend to be more influenced by the experience of real-life users, rather than a celebrity endorsement and val­ue per­son­al­ized prod­ucts.

Gen Z to herald metamorphosis of future healthcare:

That it is happening gets retreated in the caption of the Fierce Healthcare article of June 16, 2020 – ‘Industry Voices -Generation Z is a game changer for healthcare.’ It emphasized, ‘Generation Z – are likely to turn the health industry on its head with their unique expectations for how healthcare should be delivered.’

Convenience is such a paramount for Gen Z that they are often willing to forgo a personal relationship with their healthcare provider. Besides, they will come to their physician and provider armed with data, information, and knowledge, unlike the past generations. Consequently, the danger for providers is, if Gen Z doesn’t get that desired convenience, they’ll go elsewhere, the article says. Simultaneously, ‘they also want a trusted adviser who can guide them toward holistic health and wellness.’ Thus, delivering patient-centric care, capitalizing on real-world data and automated care experiences, will be key to the transformative process of healthcare.

A recent survey also vindicates that the transformation has begun:

A recent Accenture healthcare consumer survey reiterated: “The new healthcare consumer is here.” The study clearly signaled a paradigm shift in this space spearheaded by millennials and Gen Z. Some of the survey findings encompass the following areas:

  • This group of healthcare consumer expectations for convenience, affordability and quality are redefining how they engage at each stage of care.
  • They are most dissatisfied with health care’s status quo and more willing to try non-traditional services, such as, virtual care and retail walk-in clinics, which are gaining in popularity and use with them.
  • With greater health care needs, they will increasingly look for services to satisfy their expectations for effectiveness, convenience, efficiency, and transparency.
  • With millennials and Gen Z to become the largest generation in not-too-distant future, they hold the most power to influence future healthcare models.

Some pharma players are tracking Gen Z and the changing paradigm:

Some global majors, such as Abbott, are also writing about it in their website Abbott.com. The Company has noted some of these changes, as follows:

  • Generation Z’s relationship with technology will influence how the group relates to healthcare. While growing up in a fully connected world, they ‘are less likely to have primary care providers and are more likely to use apps for scheduling, viewing medical records and paying bills.’ They are also more receptive to telehealth visits and connected healthcare than previous generations.
  • With the wait times for an appointment with a doctor growing longer, Gen X populations are more likely to use walk-in clinics or opt for urgent care centers which are more convenient.
  • Self-service and convenience play into Gen Z’s interactions with doctor’s and the industry as a whole. They prefer email, texting, and apps to manage their appointments or communications with doctors. Finding ways to communicate with this younger generation in their preferred modes, can help keep them engaged with the industry.
  • Millennials and Gen Z populations are most likely to use a wearable device. They typically reach out to friends or online communities to ask about a particular health condition before speaking with a doctor. Although they aren’t the groups using the more healthcare services, millennials and members of Gen Z are showing what the health industry needs to do to provide the best care.

Size of Gen Z population in India:

According to EY Gen Z survey, released on November 04, 2021, the next decade will be shaped by the maturation of Gen Z, the largest generational cohort in history, where India stands out with a population that includes 375 million people or 27% of the total population in Gen Z. Besides, the survey also underscores the importance of Gen Z in the shifting paradigm of market dynamics for the pharma industry, as well.

Conclusion:

Currently, healthcare industry, in general, and most drug companies, in particular -especially, in India, don’t seem to nurture the fast-growing population of Gen Z with a customer engagement strategy that they can relate to. What these players are currently marketing is mostly aimed at traditional customers, and who still form the majority.

Exploring these evolving changes, I wrote an article in this blog, on November 07, 2016. This was titled ‘Millennial Generation Doctors And Patients: Changing Mindset, Aspirations, And Expectations.’ However, the unprecedented impact of Covid-19 pandemic, alongside rapid advancement and adaptation of digital technology, tools, and platforms, has expedited this process.Apace with these changes the pharma paradigm is also shifting, at a much faster pace than ever before. Which is why, I reckon, it’s important for the entire health care industry in India to be in-sync with Gen Z expectations and engage them, accordingly.

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.

 

Covid-19: Perils Of Haste In Scientific Decision-Making Process

Multifaceted threats posed by Coronavirus to the humanity, are getting increasingly complex, every day. Currently, Covid-19 cases in India are ‘the highest that any country has ever recorded on a single day since the start of the outbreak.’ Alongside, the hopes of billions of people – for its predictable and dependable remedies are also soaring sky high. But, despite full throttle global endeavor of scientists, the world continues waiting for scientific-evidence-based, well-proven, safe, and effective Covid-19 drugs, vaccines and other treatments.

It is expected, each of these cures and antidotes should be duly authorized by drug regulators, according to global norms – without any outside non-scientific interference – not even from the very top. Nevertheless, the reality is, as on date, besides some ‘emergency use authorizations’, all scientific pursuits in this area are Works in Progress (WIP) – some are with great potential, though.

The catastrophic impact of Covid-19 pandemic is all pervasive. So is the competition between media publications to attract maximum eyeballs, with details on many aspects of the disease and related scientific development. These include reports on intense, non-scientific pressure on scientists and regulators to make drugs, vaccines or other Covid-19 treatments immediately available for use. In this article, I shall dwell on the perils of haste in the scientific decision-making processes, while combating Covid-19.

A quick research outcome is important – based on ‘rational’ – but not ‘rash’ decisions: 

In pursuit of a quick disease treatment outcome, a rational and ethical approach in any scientific discovery process, is non-negotiable. It has always been so – while dealing with many different health crises, and should remain that way for Covid-19, as well. In my view, for achieving a prompt and desirable treatment outcome – a quick, but rational decision should always be favored – over highly influenced, contentious, non-scientific and rash decisions.

Many wise men believe, a quick decision is one, made quickly supported by irrefutable inputs of an accepted quality and scale. Whereas, a rash decision is one, made with limited, questionable or even no inputs – just based on gut feel, as it were. This broad concept is applicable to Covid-19 drugs, vaccines and other treatments, including -plasma therapy.

In the space of Covid-19 pandemic, there are several such examples, starting from hydroxychloroquine to the most recent plasma therapy – both in India, and also beyond its shores. Without being judgmental, this article will try to join some critical dots, for the readers draw their own conclusions on this issue. Let me start with two examples of this drug regulatory quagmire – the very first, and the most recent ones.

Perils of haste in the Hydroxychloroquine saga:

As I wrote in this blog that the US President Donald Trump, on March 21, 2020,  proclaimed Chloroquine and Hydroxychloroquine as potential game changers against Covid-19 global pandemic, despite doubts from the US-FDA. Interestingly, on March 28, 2020, the US drug regulator granted the emergency use authorization of these two drugs for treating Covid-19. However, it was subsequently revoked on June 15, 2020. The agency justified this action by saying:

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The World Health Organization (W.H.O) also announced: “Studies show Hydroxychloroquine does not have clinical benefits in treating COVID-19.” However, as published by JAMA on May 28, 2020,following President Trump’s naming these drugs at a press conference, Hydroxychloroquine prescriptions shot up by over 200 percent, over the previous year. Nonetheless, the prescriptions returned to normal as news highlighting the lack of enough evidence to support its use started spreading, across the globe.

Soon, India followed the same… a strange coincidence?

As stated above, on March 21, 2020, the US President Trump proclaimed Chloroquine and Hydroxychloroquine as potential game changers against Covid-19 global pandemic, despite doubts from the US-FDA. Curiously, on March 23, 2020, Indian media also reported:

‘Amid rising Coronavirus cases in the country, the national task force for COVID-19 constituted by Indian Council for Medical Research (ICMR) has recommended hydroxy-chloroquine as a preventive medication for high-risk population. According to the advisory, it should be given to high risk population — asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19 and asymptomatic household contacts of laboratory confirmed cases.’

The above protocol, recommended by the National Task Force, has been approved by the Drug Controller General of India (DGCI) for restricted use in emergency situations. This seems to have happened even before the US-FDA granted similar authorization. Intriguingly, US-FDA subsequently revoked it on June 15, 2020, for lack of enough scientific evidence, unlike the Indian drug regulator.

Another report of April 09, 2020 summed it up well. It wrote, the hype of Hydroxychloroquine – pushed by the US President Trump as a COVID-19 treatment, has now been joined by many other countries, despite inconclusive medical evidence on the efficacy and safety of the drug. Is this just a strange coincidence?

Be that as it may, India’s decision on the emergency use of Hydroxychloroquine had its rub-off financial impact in the country, in terms of increase in its export demand, which may not be an intended one, though.

Its rub-off financial impact in India:

As the world’s largest manufacturers of Hydroxychloroquine are located in India, many of these companies reaped a rich harvest in the April-June quarter, mostly, based on media reports on its use in treating Covid-19. For example, Ipca Laboratories Ltd, reportedly, garnered ₹259 Crore in additional sales, with consolidated net profit for the quarter soar threefold to ₹454 Crore, from the drug in that period.

Notably, Ipca also acknowledged, ‘HCQ sales were a one-time boost for the company. With the hype waning, after various clinical trials showed the drug did not provide any significant benefit, the company now expects sales to ease to earlier levels,’ as the report goes. Let me now move over to the most recent example.

Perils of haste in the plasma therapy saga:

Since, the third week of this month, a series of incidents related to plasma therapy highlighted the ongoing perils of haste in the scientific decision-making process. These were generally prompted by powerful non-scientific external influences, as reported below:

  • On August 23, 2020, the US President announced that the US-FDA has granted emergency approval of blood plasma from recovered Coronavirus patients as a treatment for those battling the disease. President Trump called the development “a historic breakthrough.”
  • According to Reuters, the US-FDA had authorized its use after President Donald Trump blamed the drug agency for impeding the rollout of vaccines and therapeutics for political reasons.
  • The very next day of President Trump’s announcement, on August 24, 2020, the World Health Organization advised caution about endorsing the use of recovered COVID-19 patients’ plasma to treat those who are ill, saying evidence it works remains “low quality.”
  • American scientists, including researchers at the Mayo Clinic also challenged a key statistic cited by U.S. officials as grounds for emergency approval of the treatment.
  • On August 25, 2020, US-FDA Commissioner Stephen Hahn, publicly apologized ‘for overstating the benefits of plasma for treating Covid-19 patients.’ 
  • “The US-FDA’s emergency use authorization for plasma for Covid-19 looks questionable. If this presages an early vaccine nod, we should be very afraid,” reported another article.

Similar controversy was also witnessed in India. Just days after the Drug Controller General of India (DCGI) gave its go-ahead to a proposal of ICMR for the clinical trial of convalescent plasma therapy in COVID-19 patients, the Ministry of Health said, ‘there is not enough evidence to claim plasma therapy can be used for treatment of COVID-19. Interestingly, several states, such as, Delhi, Gujarat, Maharashtra and Uttar Pradesh, have already started clinical trials for plasma-based treatment. Meanwhile, media reports, such as, ‘India sees black market boom for plasma from recovered Covid-19 patients,’ started pouring in.

Conclusion:

As recorded in the morning of August 30, 2020, total Coronavirus cases in India have reached a staggering figure of 3,542,733 with 63,657 deaths, despite all measures taken by the country. No signs of flattening of the curve are visible, just yet. In this situation, many experts believe, the way prescriptions are written for Covid-19 patients, based on anything but robust considerations, needs to be re-looked. The headline of an article, written by Richard L. Kravitz, Professor of Health Policy and Internal Medicine, University of California, Davis on July 09, 2020, vindicates this point. It said:‘When Trump pushed Hydroxychloroquine to treat COVID-19, hundreds of thousands of prescriptions followed, despite little evidence that it worked.’

Another interesting article, tried to ferret out the truth behind such haste. It voiced, ‘the truth is that researchers, academic institutions, medical journals and the media all face powerful incentives to portray the latest research findings as more earthshaking than they actually are’. The authors spotlighted, under normal circumstances, numerous mechanisms exist to blunt some of the worst over-hyping and many sources of medical information do their best to be accurate in what they report.

It is possible that in the midst of a pandemic, the urgency of the moment may overwhelm these good intentions. The above paper also cautioned, ‘Bad science can be spread far and wide by normally credible sources.” However, the bottom-line is, the scientific research community, under no circumstances, be made to comply with the thoughts and beliefs of non-scientific, but powerful decision makers. It happened in the oldest democracy in the world, as it also happened in the largest democracy on the planet earth.

The above two instances are just illustrations to highlight an important point – without becoming judgmental. The discussion spotlights the perils of haste in the scientific decision-making processes, while combating Covid-19. As many experts believe, it could be counterproductive for non-scientific power sources to influence the robust medical value creators for a quick remedy. Mainly because, patients will continue to be at the receiving end for the net outcome, of such unproven, and scientifically fragile hypes.

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.

What Pays More: Creating ‘Innovative ‘Customer Experience’ Or ‘Innovative Drugs’?

More innovative a drug is, the better is its business success rate. This was the general perception of around 92 percent pharma professionals in the past three years. Whereas the fact is: ‘Having the best product doesn’t guarantee sales anymore’. This was established by a research study of the ‘Bain & Company’ - covering multiple therapeutic areas, and was published on October 14, 2019.

It showed, when physicians prescribe a drug – its efficacy, safety and side-effect profile initially account for only 50 percent to 60 percent of the physician’s choice, with a declining trend over time. Interestingly, the other 40 percent to 50 percent of it, is based on a range of ‘physician and patient experience factors’, which pharma players need to target in innovative ways to differentiate their brands.

Many pharma companies are now experiencing the harsh reality that more innovative drugs, backed by traditional sales and marketing support are not yielding desirable financial returns. Head scratching has already started among astute pharma professionals to understand its reason for remedial measures. Thus, the number of executives who agreed with the above ‘Bain & Co’ study that: ‘Having the best product doesn’t guarantee sales anymore,’ increased to almost fourfold – from 8 percent to 28 percent in the next three years.

Thus, in this article, I shall explore whether innovation in creating a ‘unique patient experience’ during a disease treatment process, is as important, if not more than a ‘new drug innovation’. Curiously, high failure rate of most pharma players to innovate in this area, isn’t discussed as much as high failure rates in the development of innovative new drugs.

‘Customer service’ innovation – high failure rate – falling short of expectations:

Again, another article - ‘How Agile Is Powering Healthcare Innovation,’ published by ‘Bain & Company’ on June 20, 2019, brought out some interesting points related to this area. Let me quote a few of which as follows:

  • 65 percent of ‘customer-service innovation’ fall short of expectations of the target group.
  • The number of health care executives recognizing the need to respond quickly to changing customer-needs, has increased from 38 percent in the past three years to 60 percent for the next 3 years. But, most of them ‘lack the methodology, and even the language to implement it in practice.’
  • ‘Having the best product doesn’t guarantee sales anymore.’ Thus, healthcare companies face growing pressure to innovate in providing unique ‘customer experience’.
  • The critical point to note, customer needs evolve continuously, and leading companies respond rapidly with innovative new solutions catering to changing market demand.

As the core purpose of working for ‘customer-service innovation’ is linked with creating ‘brand loyalty’, let’s have a quick recap on ‘brand loyalty’ really means for pharmaceutical products, in today’s context.

‘Brand loyalty’ for pharmaceutical products in modern times:

There are many similar definitions of ‘brand loyalty’ for a pharmaceutical product. The research article – ‘Brand Loyalty as a Strategy for the Competition with Generic Drugs: Physicians Perspective,’ published in the Journal of Developing Drugs, on August 30, 2016, defined ‘brand loyalty,’ and articulated its advantages.‘ I am paraphrasing a few of which, as below:

  • The extent of the faithfulness to a particular brand, which is a major indicator of a long-term financial performance of companies.
  • The main advantages of brand loyalty can be defined as greater sales and revenue, a substantial entry barrier to competitors, increase in a company’s ability to respond to competitive threats and lower consumer price sensitivity.
  • ‘Brand loyalty’ can protect against price competition, including branded generics, as it gives confidence to physicians on the perceived effectiveness and safety of a brand – which they usually won’t be willing to compromise with for lower prices.

This brings us to a key question. Are traditional pharma methods of creating ‘brand loyalty’ getting replaced by the key consideration of creating a ‘unique customer experience’?

Creating ‘brand loyalty’ through ‘patient loyalty’ – a new equation:

It’s a fact today that traditional pharma methods of creating ‘brand loyalty’ is getting replaced by the key consideration of creating a ‘unique customer experience.’ This, in turn, is increasing the need of building ‘patient loyalty’, both for a pharma brand, as well as respective companies offering these brands. This is a new equation, where offering a ‘unique treatment experience’ to patients assumes a critical role more than ever before. This needs to be clearly understood by today’s pharma marketer, without any ambiguity.

In traditional pharma marketing, physicians remain, virtually, the sole focus of the branding exercise, as they appear to be the only decision makers of writing a brand prescription. Patients, in general, hardly used to have any role to play in that process. In this scenario, brand loyalty for the doctors – assuming the absence of any malpractices, is primarily driven by the following three much known factors:

  • Physicians’ unprejudiced buying-in a brand’s value offerings
  • Evaluation of opinion leaders and the doctors’ professional counterparts,
  • Quality of disease treatment outcomes.

Nevertheless, before getting into this area, let’s have a quick look at the primary drivers that pharma marketers have been using to boost financial performance of a brand.

Traditional sales boosters of a pharma brand:

The primary drivers that pharma marketers have been using to boost financial performance of a brand can broadly be classified as follows:

  • Multiple ways are followed to make important doctors write more prescriptions,
  • Increase the drug price, whenever an opportunity arises.

These factors still remain important, but aren’t just enough to deliver sustainable performance over a period of time. Thus, a new dimension needs to be added to it.

Add a new dimension to create brand and corporate loyalty:

With the emergence of increasingly more informed and demanding patients, there is a need to create a ‘loyal patient population’, by offering them primarily a ‘unique treatment experience’. And this is the new dimension.

For this purpose, off-the cuff approaches or strategies based on mere gut-feelings are unlikely to work. As I indicated in one of my articles, marketers need to acquire deep insights on their customers to make sales and marketing decisions more informed, than what it is today. Currently available state of the art technology can be a great enabler to facilitate this process.

This is easier said than done, because answering the question – how does a drug company create ‘brand loyalty’, is indeed a tough call. Nonetheless, many different industries have realized, since long, that offering a ‘unique customer experience’, is critical to create a pool of ‘loyal customers’.

I also had written earlier, pharma is still a late learner in accepting various new normal, in a holistic way. Accepting this reality, a sharp focus on creating ‘brand loyal doctors’ in various innovative ways, I reckon, will serve this purpose well. It’s only recently, a few companies have started working to offer such ‘experience’ to patients in the disease treatment process - end-to-end. Ironically, a large majority of them prefer to talk about it more than actually translating the same into reality.

Benefits of ‘brand loyalty’ through ‘unique customer experience’:

There are several advantages of building pharma ‘brand loyalty’ by offering ‘unique customer experience, without diluting the focus on ‘increasing prescription generation through doctors’. The benefits, I reckon, include, both new – innovative products and also branded generics. Let me give below one example of each:

  • Innovative new-products – positive word-of-mouth promotion: Satisfied patients having ‘unique end-to-end treatment experience’ with a new, innovative brand, are very likely to share it with others. This may be done by using different modes of communication, including various social-media platforms. This, in turn, may help both – add to take-off speed – post launch and create a snowballing impact on the brand adoption thereafter.
  • Branded generics – extend the product life cycle and increase growth: Patients who are loyal to a particular branded version of a generic molecule, are quite likely to refuse any change to a cheaper equivalent, even if recommended by the physician. Moreover, they will advocate for this brand to others, using different communication platforms, as indicated above. Continuation of this process will extend the life cycle of the branded-generic, with increasing growth and market share.

Conclusion:

Now, it’s time to get back to what we started with - What pays more: Creating ‘Innovative ‘Customer Experience’ Or ‘Innovative Drug?’ From the above perspective, it emerges that bringing innovative product to markets is, of course important. However, to ensure its sustainable financial success, other innovations, such as creating ‘a unique end-to-end patient experience’ with the brand, in all probability, would weigh more. This is an area which did not receive much attention for a long time, moving beyond the creation of increasing numbers of ‘brand loyal’ doctors, for business success.

Today, increasing consumerism in the health care space, besides pricing pressure, unfavorable perception and sinking image of the industry, is creating a strong headwind – impeding desirable growth of many pharma players. Such a challenging business scenario has prompted a few of them to innovate in designing a differentiated ‘customer experience’ – in a true sense.

Although, a large number of companies are talking about it, most are mere lip-services – a ground-swell in this area is yet to take place. The industry priority, in general, still weighs heavily in developing innovative products, and creating ‘brand loyal’ doctors, rather than cultivating ‘brand loyal patients’, alongside.

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.

Focus On Patient Compliance To Boost Pharma Sales…And More…

One high-impact area in the healthcare space that often finds its place in the backseat is – patient noncompliance. A term that is commonly used in regard to ‘a patient who does not take a prescribed medication or follow a prescribed course of treatment.’ It comes with a steep price, for causing serious adverse impact not just on human health and health system, but also in the pharma business. Intriguingly, such incidents are still not scientifically monitored enough and vigorously acted upon, both globally and locally.

The World Health Organization (W.H.O) has also flagged it as a huge problem, as it reports, 10 percent to 25 percent of hospital and nursing home admissions result from patient noncompliance. Furthermore, about 50 percent of prescriptions filled for chronic diseases are not taken correctly, with 40 percent of patients not adhering to the treatment regimen.

In this article, just after giving a flavor to its financial cost to patients, I shall dwell mostly on its impact on the pharma players, as overcoming this important problem doesn’t generally fall in the area of strategic focus for most of them. Finally, I shall explore how drug manufacturers can translate this problem into an opportunity – as the third growth driver for business, creating a win-win situation for all.

Economic and health impact on patients:

Noncompliant patients suffering from both acute and chronic ailments, pay a heavy price, not just in terms of longer suffering arising out of complications, but also incurring significantly more health expenditure for treatment of the same diseases. According to IMS Institute for Healthcare Informatics, on average, less than 40 percent of patients around the world are fully complying with their treatment instructions.

Even in the Indian context, the problem is no different. Let me illustrate the point with the example of a chronic disease, such as Asthma. The article published on June 26, 2018 in ‘Lung India’ – the official publication of Indian Chest Society reported: “The mean annual direct costs among compliant and non-compliant patients were ₹14, 401 and ₹24, 407, respectively. Percentage of hospitalization was less among the compliant group (6 percent) when compared with noncompliant group (17 percent).”

The study concluded, asthma is not only associated with patient-specific impairment, but also creates a significant economic burden for the family and society. The major contributors to the burden are the medication cost and hospital admissions. Patient compliance with prescribed drugs can help keep asthma under control, thereby decreasing the economic burden and emergency hospital admissions – avoiding the economic risk from ill health with high out of pocket payments.  Productivity loss is another under-appreciated source of economic loss contributing to indirect cost. The rising costs of investigations, interventions, and treatment of chronic diseases further complicate the problem.

Economic impact on pharma business:

According to November 16, 2016 report, published by Capgemini and HealthPrize Technologies, globally, annual pharmaceutical revenue losses had increased from USD 564 billion in 2012 to USD 637 billion due to non-adherence to medications for chronic conditions. This works out to 59 percent of the USD 1.1 trillion in total global pharmaceutical revenue in 2015.

The report highlights, besides medication nonadherence being a serious global health issue that needs to be addressed immediately, it also happens to be a critical business issue for pharmaceutical companies. Thus, it is the only area of their business where a sharp strategic focus “can generate significant top – and bottom-line growth, improve outcomes, and create substantial savings for the healthcare system – all at the same time.”

Major reasons for patient noncompliance:

Several reasons are commonly attributed to patient-noncompliance to medicines, such as:

  • Lack of knowledge of its health and economic impact
  • Importance of completing the full-course of the drug and dosage regimen for long-term remission, following immediate relief
  • Untoward side-effects and other inconvenience
  • Forgetting therapy because of preoccupation
  • Financial inability to complete the prescribed treatment regimen due to the high cost of drugs.

Nevertheless, the 9th Edition of Global Research Report by Capgemini Consulting underscores that reality is more complex. Patient adherence initiatives, if any, when undertaken, even by pharma companies, often lack a thorough understanding of the root causes of discontinuing treatment and failure to effectively engage patients with a holistic approach to the issue. It also emphasizes: “Individual tactics are tried by different brands and then discontinued as budgets and priorities shift, before their impact is known. Successes are seldom pulled through and expanded across the organization.”

Using it as the third major growth drivers for pharma:

The two primary factors that drug manufacturers are leveraging to boost growth of the organization are:

A.  New product introduction – gradually extending to line extensions and new indications. One such illustration is the cholesterol-fighting drugLipitor of Pfizer. The lifetime sales of this brand as of the end third quarter 2017 generated a stunning USD 150.1 billion of business for the company. Incidentally, Lipitor patent expired in 2011. There are many similar examples, including Humira of AbbVie.

B.  Regular and hefty price increases for already marketed products, for various reasons, but almost regularly. According to this 2019 report, percentage price increases, on a huge base, of some of the world’s top pharma brands were as follows:

  • AbbVie: Humira, a blockbuster drug with USD 15 billion in sales in the first 9 months of 2018: +6.2%
  • Allergan: Many of its brand-name drugs, including dry-eye medication Restasis: +9.5%
  • Biogen: Multiple sclerosis drug Tecfidera: + 6%
  • Bristol-Myers Squibb: Eliquis, a drug that prevents blood clots and is on pace for USD 6 billion in sales in 2018: + 6%
  • Eli Lilly: Type 2 diabetes medication Jardiance: + 6%

Many studies have captured the importance of regular price increase, as a key pharma strategy, not only to drive the internal growth, but also to keep their investors, as well as, the stock market on the right side. There are examples that for some of the top global pharma players, this strategy was directly responsible for 100 percent of earnings-per-share growth in 2016, and more than 20 percent of the revenue made in the first three quarters of 2018.

On the other hand, some top analysts’ findings highlight that drug companies serious strategic focus just on the issue of patient noncompliance with novel tactical measures, could fetch as much as a 30 percent increase in annual earnings per share for many players, even in India.

This brings up to the point – can strategic focus to minimize patient’s non-compliance, supported by adequate resources, be the third growth driver for drug companies?

Can focus on patient noncompliance be the third growth driver for pharma?

For a moment, leaving aside the above two primary growth drivers, if we look at the estimates, as quoted above, well over 50 percent to 60 percent of a brand’s potential sales is wasted due to patient noncompliance. Isn’t it huge? Can this be ignored? Obviously not. Instead, why not pharma converts this problem into an opportunity, with a sharp strategic focus, leveraging technology.

Translating this potential opportunity into reality is neither very easy nor is every company’s cup of tea. But the reward for the winners is indeed phenomenal. To chart on this frontier, one of the toughest barriers, besides a winner’s mindset, is getting access to credible and meaningful patient-data, for various reasons. On the other hand, it isn’t an insurmountable problem, either – especially, with today’s rapidly progressing technology.

Some companies have started the long march:

According to the review article, published in the New England Journal of Medicine: ‘The ability of physicians, to recognize non-adherence is poor, and interventions to improve adherence have had mixed results. Furthermore, successful interventions generally are substantially complex and costly.’

Realizing that it as a potential opportunity – disguised as a problem, several pharma players have started thinking about exploring this not much charted territory, confirm reports coming from different countries of the world. To give an illustration, November 22, 2016 edition of Fierce Pharma reported: ‘Pharma companies have more recently joined the conversation with partnerships and programs that include adherence aims.’

It is generally believed today that rapid ascendency of modern technology, and its strong influence on people, will help create a new awareness of its current adverse impact both on patients and the drug companies.

What else could be done in a much wider scale?

Digital interventions, such as smartphone apps, are becoming an increasingly common way to support medication adherence and self-management of chronic conditions. In this regard, the May 14, 2018 study titled, ‘Smartphone apps for improving medication adherence in hypertension: patients’ perspectives’, published in the journal of Patient Preference and Adherence, concluded as follows:

‘These data showed that patients can identify the benefits of a medication reminder and recognize that self-monitoring their blood pressure could be empowering, in terms of their understanding of the condition and interactions with their general practitioners.’ But some loose knots are still to be tightened.

Tightening the loose knots:

Having leveraged the state of the part digital technologies to tighten the loose knots in this area,a host of AI-enabled smartphone health and diagnostic apps, capturing patient compliance details, especially in chronic disease areas, are fast coming up. Most of these are being developed by large, small and medium sized non-pharma pure tech companies, including startups. For example, according to reports: ‘With the release of the Apple Health Record and Apple Watch with a single-lead ECG, it’s evident that Apple has officially entered the healthcare space.’

A good number of these apps have received even the US-FDA approval, such as: MyDose Coach - a reliable dose calculating app for type 2 diabetic patients who take insulin once-daily in concert with physician guided insulin recommendations. Or, GoSpiro – a home spirometer, to measure air output from the lungs for COPD patients and connects wirelessly to provide hospital-quality data regarding breathing.

That many non-pharma entities are trying to create a space for themselves in a high-tech, but non-drug treatment segment within the pharma space, has prompted, several drug manufacturers to rewrite their marketing playbook, incorporating this ‘new notation’.

It’s real now…for some:

As the above Fierce Pharma article reported: ‘Pharma companies have more recently joined the conversation with partnerships and programs that include adherence aims; efforts from Verily and Sanofi and IBM and Novo Nordisk have recently made the news.’Further, on November 07, 2018, in another report it brings to the fore that Geisinger Health System has developed mobile apps to manage asthma with AstraZeneca, and a wearable app to manage pain with Purdue. It also joined forces with Merck to develop tools for patients and caregivers to improve care coordination and medication adherence.

Moreover, on February 09, 2019, Japanese drug major Astellas and WiserCare - a company that develops healthcare decision support solutions, announced a collaboration that includes improving patient adherence to care plans, and improve the overall care experience.

In tandem, concern on patients’ data privacy, may also now be addressed, possibly by making use of blockchain or similar technology for such initiatives, as I discussed earlier in this blog.

Conclusion:

‘Acquiring new customers is important, but retaining them accelerates profitable growth,’ is the theme of an article, published in Forbes on June 08, 2016. Therefore, just as any other business, this dictum applies to the pharma industry, as well, especially in context of patient noncompliance to medicines, with a clear strategic focus to minimize its impact on performance.

The major reasons for patient noncompliance ranges from ignorance of its adverse impact on health to side effects, forgetfulness and right up to inability to afford full-course of the prescribed drug treatment. Despite its continuity over decades, adversely impacting patients, health system and the pharma players, it won’t be prudent to infer that no attempt was being made in the past, to address this critical issue. Nevertheless, those measures have not worked, for many reasons, as we see today from various research studies in this area, even in the Indian context.

Once again, intervention of technology to make patients compliant to medicine, is showing promise for following it up more vigorously. That some global drug majors are entering into collaborative arrangements with non-pharma, technology companies of various sizes, sends a signal of the emergence of a third major growth driver for pharma, as discussed above.

This issue is so important, especially considering that the low hanging fruits of R&D have mostly been plucked, just as regular hefty increases of drug prices are meeting with tough resistance, squarely. In this scenario, a robust strategic focus on patient compliance would not only boost pharma sales but would also reduce the disease burden of a large section of people significantly. This will benefit all and harm – none.

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.

Will AB-NHPM Mitigate Indian Healthcare Crisis?

Since long, hypes have created on several healthcare schemes in India, by the successive Governments of different political dispensation. These attracted mostly positive vibes at the time of announcements. Nevertheless, as we move on, a vast majority of Indians continues to live in the midst of a health care crisis, as it were.

The National Health Policy 2017 also acknowledges this crisis as it writes: ‘growing incidences of catastrophic expenditure due to health care costs, which are presently estimated to be one of the major contributors to poverty.’

More recently, the May 31, 2018 article, published in the British Medical Journal (BMJ) continued to echo the similar concern. It reiterated, since both government funding and social health insurance contributions are insufficient to meet health care needs of households, over three-fourth of all healthcare payments are paid Out of Pocket (OOP) at the point of service delivery while medicine purchase (approximately 63 percent) account for the single largest component of these payments.

A major cause of catastrophe and impoverishment at the household level is undoubtedly the OOP expenditure on health care, including medicines. According to the above BMJ paper, 29 million households, implying about 38 million persons were pushed into poverty in the year 2011–2012, only because of this reason. Although, this study was based on a cross- sectional analysis of ‘National Sample Survey data, 1994–2014’, the public health expenditure in India has not shown any significant increase since then, either. On the contrary, the public spending in some health-related areas has come down in the recent years.

Is a health care crisis primarily a ‘financial’ crisis?

The issue of budget allocation and adequate public expenditure on healthcare in India assumes significance to understand this point better. It is generally believed that ‘a health care crisis is primarily a ‘financial’ crisis in which countries cannot successfully meet people’s access to medicine due to the rising cost of health care services and, more importantly, pharmaceuticals.’ A sincere political will is absolutely necessary to resolve these issues, meaningfully – the paper points out.

But, there doesn’t seem to be any financial crisis in the country now, as the Government claims. India is the fastest growing nation in the world. Why is then the health care crisis continuing for the majority of Indian, if not worsening? Why isn’t public expenditure on health care increasing despite such spectacular financial achievements? Could it be due to lack of requisite political intent?

On paper all health care related schemes look good:

Yes, I reckon, on paper all health care related schemes look reasonably good, assuming these will be implemented well. These may include, National Health Missions (NHM) covering both rural and urban poor or even the likes of Rashtriya Swasthya Bima Yojana (RSBY). So is also the most recent one - Ayushman Bharat – National Health Protection Mission (AB-NHPM) announced by the Government during 2018-19 Union budget presentation and approved by the cabinet on May 21, 2018. However, its implementation on the ground seem to be wobbly, too. Thus, many wonders whether this new scheme on the block will help the nation tiding over the existing health care crisis.

I broadly discussed this subject on February 5, 2018, in this Blog. However, in this article, I shall try to ferret out the reasons of such apprehension on the AB-NHPM, against some critical parameters, just as illustrations:

Who contributes and how much to health expenditures: 

From the National Health Account Estimate (NHAE) of October 2017, one gets a broad idea of who contributes and roughly how much of the health expenditures in India, as follows:

Union Govt. State Govts. Local bodies Enterprises, including insurance NGOs External donors OOPE
8.2% 13.3% 0.7% 4.4% 1.6% 0.7% 67%

Where does the treatment take place?

Place Urban (%) Rural (%)
Public healthcare 21 28
Private healthcare 79 72

It is interesting to note, although private health care costs over 4 times more than the public healthcare, more patients are compelled to go for private health care. (Source: National Sample Survey 2014, Ministry of Statistics and Program Implementation.)

Reasons for not using public health care facilities:

Around55.1percent of households are not using public health facilities.The reasons for not using public health care facilities by the members of the household when they fall sick, as reflected in the National Family Health Survey (NHFS) data, are interesting. Following are the main reasons:

Poor quality of care No nearby facility Long waiting time Inconvenient facility timing Health Personnel absent
48.1% 44.6% 40.90% 26.4% 14.8%

Addressing these reasons would help significant reduction in OOPE:

The February 2018 report of the ‘Centre for Technology and Policy Department of Humanities and Social Sciences, IIT Madras,’ vindicates this important point. It provides unambiguous evidence that strengthening the basic infrastructure of Health Sub-Centers (HSC), along with trained personnel and adequate medicines, ensure diversion of patients from expensive private facilities – increasing patients’ access to affordable health care. Consequently, OOP expenditure by families in health care and particularly medicines, sharply comes down.The study reported that such reduction in outpatient care varied between 77 percent and 92 percent in a pilot project on ensuring universal health coverage.

Break-up of healthcare expenditure – primary care costing the most:  

One gets a broad understanding on the general break-up of health care expenditure in India from the (NHAE) of October 2017, as follows:

Primary care Secondary care Tertiary care Patient transportation Governance & supervision
45.1% 35.6% 15.6% 4.6% 2.6%

It is worth noting that transportation costs are significant for many patients, just for accessing the existing public or private health care facilities, besides getting important diagnostic tests done, or even to buy many medicines. This expenditure would continue to exist, even if NHPS is put in place. On the other hand, strengthening the low-cost Government HSCs, would help greater patient access to health care, bringing down the OOPE, remarkably.

Currently, a sizeable number of reasonably decent medical treatment points, are located quite far from many villages. Thus, availing any decent health care facility by a large number of rural folks, no longer remains a matter of choice, up until the disease turns into a life-threatening one, due to protracted negligence. One such example is a large number of child deaths occurred at the state-run BRD Medical College hospital in the Gorakhpur city of Uttar Pradesh, in 2017. Most of them were brought in a critical condition from far-off villages.

Highest OOPE expenditure incurred for outpatient treatment:

According to the December 2016 publication titled ‘Household Health Expenditure in India’  of the Union Ministry of Health, one will get an idea of top 3 key consumption areas, out of the total OOPE on health care services, which are as follows:

Outpatient care Inpatient care Preventive care
54.84% 31.96% 4.26%

However, of the total OOPE, 53.46 percent was spent on medicines and 9.95 percent was spent on diagnostics. More importantly, 82.29 percent of the total OOP medicines expenditure and 67 percent of total OOP diagnostic expenditure were in outpatient treatment, the report highlights.

New NHPM excludes two major components of OOPE: 

Based on the above facts, it is interesting to note, while the maximum expenditure for health is incurred towards Primary Care and Outpatient treatment, the brand new NHPM does not cover both. In that case, how will it address the health care crisis in India and significantly reduce OOPE on health?

Does the total cost for AB-NHPM reflect in any budget allocation?

In this context, let me touch upon the other aspect of AB-NHPM, which is giving shape to 150,000 ‘Health and Wellness Centre (HWC)’ in India.On April 14, 2018, the first HWC – under the AB scheme was launched by the Prime Minister of India at Bijapur in Chhattisgarh.But, the fund allocated in the Union Budget 2018-19 for HWCs is just Rs. 120 million, which realistically is expected to support just around 10,000 HWCs. Whereas, 150,000 HWC would cost around Rs. 3 billion. The same issue of abysmal budgetary allocation, both by most of the state governments and the center, has been raised for NHPM, as well.

As we have seen in the chart of ‘who contributes and how much to current health expenditures’, that OOPE stands out, it should in no way be allowed to remain around that number in India, because of continuing low public health expenditure on health care.

Conclusion:

Coming back to what I started from – the issue of ongoing health care crisis in India with incredibly high OOPE expenditure of the households on health. Many health care schemes have come, gone or about to be jettisoned – getting replaced by the tweaked versions of the old ones – of course in a new Avatar, supported by much expected media hypes, virtually terming it as a panacea. But, the key problem of sincere implementation of those schemes still lingers.

Sharp Government focus, backed by adequate budget allocation, on primary health care and bringing down outpatient treatment cost, which contribute to a high proportion of OOPE, remain as elusive as ever. Thus, I reckon, AB-NHPM is unlikely to mitigate the health care crisis in India, at least,in the short to medium term.

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.

 

Clinical Trials: Critical Need To Improve Patient Participation With Informed Consent

On April 13, 2016, an article in the Wall Street Journal (WSJ) titled, “Clinical Trials Need More Subjects” underscored an important point that the rate at which the clinical researchers are able to recruit and retain patients for ‘Clinical Trials (CT)’, has now hit an all-time low. This is vindicated by studies that indicate less than 10 percent of Americans now participate in clinical trials, and only 3 to 5 percent of patients sign up for trials of new cancer therapies, in the largest CT market of the world.

As a result, about 40 percent of CTs do not recruit enough patients to meet their goals, the article highlights. Consequently, a large number of pharma industry sponsored CTs are now, reportedly, moving away from the United States. India should, therefore, take note of this development and pull up the socks.

If similar situation gets replicated in other countries too, and persists, it would be very unlikely that critical and credible medical and scientific knowledge that can significantly improve the treatment outcomes in many serious disease conditions could be meaningfully gathered and put to practice. Its other serious fallouts too, are also not terribly difficult to imagine.

A key medical research tool: 

In pursuit of the advancement of medical knowledge and patient care, CT of drugs is universally considered to be a key medical research tool, as it is the best way to learn what works best in treating various types of diseases. It goes without saying that drugs for all new types of treatments would need to be discovered first through a long and painstaking process of discovery research. These are then purified, and tested in preclinical studies, before a final decision is taken for commencement of CT on human against preset parameters, as deemed necessary.

While going through this stringent process some drugs are found to be safe and effective on human subjects and some others are not, on the contrary may be harmful.

There lies the crucial importance of CT for all scientific evidence based medicines. According to the Department of Health & Human Services of the United States, Clinical research is done only if doctors don’t know:

  • whether a new approach works well with people and is safe and
  • which treatments or strategies work best for certain illnesses or groups of people 

CT, though a small part in the important and lengthy process of developing newer treatments, significantly helps the health care decision makers to decide on the treatments that work best for any patient.

Broad types: 

Pharmaceutical companies usually sponsor CT for new drugs and treatments, which are carried out by the designated research teams, consisting of doctors and other related professionals in different specialized areas.

There are 4 phases in any CT, which are broadly as follows:     

  • Phase I: Here, for a new treatment, an investigational drug is tested for the first time in small numbers, usually between 20 and 100, on healthy volunteers, to identify the proper dosage ranges for drug administration, while critically monitoring its method of absorption, adverse effects and toxicity profile.
  • Phases II: This phase, just as Phase I studies, also tests the drug on, usually between 100 and 300 patients, suffering from the targeted disease conditions. Safety is the main goal of this phase of CT and is programmed towards adjusting treatment doses, monitoring the common side effects, and whether patient’s disease condition improve as a result of the drug. These studies are usually randomized and double-blinded, where neither the patient nor the researchers would know whether a patient is receiving the investigational drug, or a placebo, or a standard treatment.
  • Phase III: In this phase, the investigational new drug goes through rigorous testing of safety, efficacy, and proper dosage levels in a large group of subjects, which may even exceed several thousand, with a specific illness or disease. The key objective is to enable the doctors to evaluate the safety and effectiveness of the treatment for various groups of patients, such as, men versus women, elderly versus young, besides many others. 
  • Phase IV: Such studies are done after the drug receives the marketing approval from the drug regulator. The basic objective of these trials is usually to monitor whether the treatment offers desired benefits or gives rise to long-term side effects, which were not seen in the phase II and III trials. This phase may involve even several hundreds and thousands of patients.

It is worth noting that CT is essential to obtain marketing approval for any new treatment, as required by the drug regulators in the different countries, and takes around 6 to 8 years.

The role of patients:

Patients play a critical role in the entire scientific value chain of any drug evaluation process, especially on human. It is absolutely necessary, particularly in the regulated markets of the world, that all medicines are fully vetted through highly regulated, stringently monitored and well-scrutinized CTs, to ensure safety and effectiveness of each new drug and treatment for the patients.

No CT can take place sans the willingness and informed consent for participation of thousands of patients for any such studies held across the world. Without adequate patient participation in a CT, the drug performance data may also not be credible and thus acceptable to the drug regulator. This would, consequently, make it impossible to bring any new drug for prevention or treatment of various, often life threatening, disease conditions. 

Major reasons for not enough patient participation:

There are many reasons for not enough patients volunteering to participate in the CT, even in India. Some of the major reasons have been identified as follows:

  • Patients often are not aware that such trials also offer a treatment option. In many cases, their doctors too may not be explaining it effectively to them, as a part of their professional discourse. Several studies conclude that trust in a physician is a main reason patients decide to participate in CT.
  • Some patients, after reading media reports, interacting with some NGOs and also from word of mouth, mistrust the CT process and suffer from fear of being a guinea pig.
  • At times, complicated protocols, and eligibility requirements may also be discouraging.
  • Many patients, especially in India, are not very clear about the exact insurance (financial) cover the study provides for them, along with other payments for the care that they would receive during the trial, or for any drug-related long term untoward incident even after completion of the CT.

All these need to be effectively addressed. 

India attractiveness for CT:

The number of CT conducted in India had increased with a rapid pace till 2012, driven by cost arbitrage, treatment-naïve patient population, qualified English speaking medical research professionals that the country offers. According to available reports, in 2009, outside the United States, India was the second most preferred country to conduct CT. Incidentally, at that time, the CT guidelines in India were too loose, quite discretionary, patient-unfriendly and with many gaping holes. This scenario has changed dramatically since 2013, with consequent adverse impact on the number of CT in India.

A 2009 study conducted by Ernst & Young and the Federation of Indian Chambers of Commerce and Industry of India (FICCI), states that India participates in over 7 percent of all global phase III and 3.2 percent of all global phase II trials. The major reasons of India attraction of the global players to conduct CT in the country, were highlighted as follows:

  • Cost of Clinical Trial (CL) is significantly less in India than most other countries of the world
  • Huge treatment-naïve patient pool with different disease pattern and demographic profile
  • Easy to enroll volunteers, as it is not very difficult to persuade poor and less educated people as ‘willing’ participants. This may not be so easy now with the recent amendment of CT guidelines. 

However, there is an urgent need for a world class capacity building in this area to reap a rich harvest.

Improving CT regulations in India: 

Not so long ago, it came to light with the help of ‘Right To Information (RTI)’ query that more than 2,000 people in India died as a result of Serious Adverse Events (SAEs) caused during drug trials from 2008-2011 and only 22 of such cases, which is just around 1 percent, received any compensation. That too was a meager average sum of around US$ 4,800 per family.

It has been widely reported that pharmaceutical companies often blame deaths, that occur during trials, on a person’s pre-existing medical condition, and not related to CT.

This gloomy situation is now gradually improving. According to an August 2015 research article titled “Impact of new regulations on clinical trials in India”, published in International Journal of Clinical Trials, 2015 Aug; 2 (3): 56-58, there was a need of strict vigilance and regulations for conducting CT in India, which was much easier than in North America or Europe. In India, the trial participants were exploited because of illiteracy, poverty and lack of awareness of their basic rights in this area. The Central Drugs Standard Control Organization (CDSCO) has now taken a noteworthy step by launching online Clinical Trial Registry-India (CTRI) ensuring accountability, transparency and information sharing on clinical trials in the public domain.

Followed by a tough intervention of the Supreme Court in 2013, Indian Government brought in amendments to the CT guidelines of Schedule Y, in December 2014 which came into force effective June 2015. These long-overdue amendments are expected to strengthen the CT process in India and effectively protect the rights, desired safety and general well-being of the participating subjects, while generating authentic clinical data for new drugs or treatment.

Informed consent:

Obtaining informed consent of the participating patients, is absolutely necessary for the researchers. This has recently been made stringent in India effective June 07, 2013. From that date, to make the sCT process transparent and ensure requisite confidentiality, an audio-visual recording of the ‘informed consent’ process has been made mandatory in the country.

A valid consent would mean that the participants have well understood the risks and benefits of the treatment during the CT period and after, along with the general procedures that he or she would need to undergo during the given time-frame.

However, the question that is still being debated, primarily because of the continuing challenge in defining in each case, beyond any scope of doubt, what should be universally considered as an adequate level of information given to the patients to obtain consent of participation in the CT. 

Financial compensation process:

Currently, the calculation of financial compensation, wherever applicable, is based on a well-defined formula. This system has been made mandatory for the sponsor in India for any trial related injuries or death. Such compensation has to be paid, even when the trial related injury is discerned after the completion of the CT. The concerned participants would receive this compensation over and above the free medical management of injury, which in any case has to be provided by the sponsor.

Hence patient safety and compensation related issues pertaining to CT in India have, to a great extent, been addressed, though there is still more scope for improvement on an ongoing basis.

Another major issue still to be addressed:

It is generally expected that when CT of a new drug is conducted by the global pharma players in India with the participation of Indian patients, the same drug when launched in other countries would also be made available in India for the benefit of Indian patients. 

Unfortunately, the situation is not so, as indicated by a paper titled, “A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa”, published in the BMJ Open on August 31, 2015.

The objective of this study was to assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa.

The study found that out of CTs with the participation of test centers in India and/or South Africa, 39.6 percent (India) and 60.1 percent (South Africa) CTs led to market authorization in the EU/USA, without a New Drug Application (NDA) approval in India or South Africa. 

The paper concluded, despite an increase in CT activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Hence, the drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population, the article suggested. 

I hope, the CDSCO would take remedial measures to address this situation, soon.

Indian pharma players should get their act together:

In view of the international media reports on alleged ‘CT data fudging’ by some of the larger Indian players in the pharma and relator sectors, there is an urgent need of the Indian pharma players to get their acts together, without any further delay.

On April 15, 2016, Reuters reported, “India’s Alkem Laboratories has been accused by Germany’s health regulator of fudging data on clinical trials of an antibiotic and brain disorder drug, becoming the third Indian firm to be scrutinized since 2014 for suspected manipulation of trial data.” However, a day later Alkem said that it was submitting suitable clarifications to the European Medical Agency (EMA).

Be that as it may, if the allegation for such gross violations of basic ethical standards is true, it would bring shame not just to the companies concerned, but also to India as a trusted source for pharma products and services. Such alleged foul play has the potential to ultimately shatter the stakeholders’ confidence, including patients, on CTs done by the Indian players, both for the local and global markets. 

Conclusion:

At the long last, after a grueling experience and tough intervention of the Supreme Court of India, CTs conducted in India are now reasonably well regulated and generally seem to comply with ethical requirements and standards. The question of human ‘guinea pigs’ and its associated concerns have also been adequately addressed by the CDSCO now.

Gradually improving the CT regulatory environment in India, barring some avoidable aberrations, offers some significant direct and indirect benefits to all concerned. Indian pharma is, therefore, expected to handle this sensitive opportunity with great care and following the highest ethical standards. 

This, in turn, would help bring to the market robust evidence-based new drugs and treatment for many types of diseases, and at the same time could facilitate their early access to many patients, at a time of dire need.

Through increasing access to CT, the participating patients would be able to avail several important benefits, such as, new and still unavailable treatment options, especially for those serious ailments, where other existing drugs either are not working effectively with satisfactory results, not affordable to many, or not working at all. In that sense, CT could offer to a sizeable number patients several other treatment options to choose from, especially, for many life-threatening diseases. This important benefit needs to be explained to the patients from credible sources, and thus merits serious consideration by the practicing medical professionals.

However, it is also a fact, particularly, in India that some people are lured to, or voluntarily enroll themselves for CT with an objective to make some extra money. Let me hasten to add that there are many other patients for whom the compensation for participation in the CT is no more than just an extra bonus.

Hence, improved patient participation with informed consent, to avail an important medical option in the disease treatment process, encouraged by the doctors without having any vested interest, has a great potential to create a win-win situation, for all concerned.

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.

Is The Indian Patent Regime Weak?

“India misuses its own IP system to boost its domestic industries,” US Senator Orrin Hatch commented while introducing the 2014 report of the Global Intellectual Property Centre (GIPC) on ‘International Intellectual Property (IP) Index’. In this report, India featured at the bottom of a list of 25 countries, scoring only 6.95 out of 30.

The reasons for this low score, especially true in the case of the pharma sector, are the US view that India’s patentability requirements are in violations of Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, the non-availability of regulatory data protection, non-availability of patent term restoration and the use of compulsory licensing (CL) for commercial, non-emergency situations.

Given this, one could, erroneously though, assume that the Indian Patent Act is weak and not TRIPS-compliant….

To read more of this article, along with another interesting expert view, please click on The Financial Express March 4, 2014.

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.

Buying Physicians’ Prescriptions in Cash or Kind: A Global (Dis)Order?

Recently a European business lobby reportedly raised its voice alleging pharma Multinational Corporations (MNCs) in China have been ‘unfairly targeted’ by a string of investigations into bribery and price-fixing cases despite their generally ‘strong legal compliance’ and has suggested that China ‘must step back.’

Two comments of this European lobby group, presumably with full knowledge of its past records, appear indeed intriguing, first – ‘unfairly targeted’ and the second – ‘China must step back’, that too when a reportedly thorough state investigation is already in progress.

Reality is all pervasive:

However, while looking over the shoulder, as it were, an altogether different picture emerges and that reality seems to be all pervasive.

Over the past several decades, the much charted sales and marketing frontier in the pharmaceutical industry has been engagement into a highly competitive ‘rat race’ to create a strong financial transactional relationship, of various types and forms, with the physicians, who only take the critical prescription decisions for the patients. Most of the times such relationships are cleverly packaged with, among many others,  a seemingly noble intent of ‘Continuing Medical Education (CME)’ by the companies concerned.

Increasingly, across the globe, more questions are now being raised whether such pharmaceutical business practices should continue even today. These voices are gradually getting louder fueled by the recent moves in the United States to ‘separate sales and marketing related intents of the drug industry from the practice of medicine’, especially in large medical teaching hospitals, in tandem with the enactment and practice of ‘Physician Payment Sunshine Act 2010’.

A recent article titled, “Breaking Up is Hard to Do: Lessons Learned from a Pharma-Free Practice Transformation”, published in the ‘Journal of the American Board of Family Medicine’ deliberated on an interesting subject related to much talked about relationship between the doctors and the pharmaceutical players.

The authors argue in this paper that significant improvement in the quality of healthcare in tandem with substantial reduction in the drug costs and unnecessary medications can be ensured, if the decision makers in this area show some willingness to chart an uncharted frontier.

‘Questionable’ relationship in the name of providing ‘Medical Education’:

‘The Journal of Medical Education’ in an article titled “Selling Drugs by ‘Educating’ Physicians” brought to the fore the issue of this relationship between the pharma industry and individual doctors in the name of providing ‘medical education’.

The article flags:

The traditional independence of physicians and the welfare of the public are being threatened by the new vogue among drug manufacturers to promote their products by assuming an aggressive role in the ‘education’ of doctors.”

It further elaborates that in the Congressional investigation in the United States on the cost of drugs, pharma executives repeatedly stated that a major expenditure in the promotion of drugs was the cost of ‘educating’ physicians to use their products.

The author then flagged questions as follows:

  • “Is it prudent for physicians to become greatly dependent upon pharmaceutical manufacturers for support of scientific journals and medical societies, for entertainment and now also for a large part of their ‘education’?”
  • “Do all concerned realize the hazards of arousing wrath of the people for an unwholesome entanglement of doctors with the makers and sellers of drugs?”

Financial conflicts in Medicine:

Another academic paper of August 13, 2013 titled, “First, Do No Harm: Financial Conflicts in Medicine” written by Joseph Engelberg and Christopher Parsons at the Rady School of Management, University of California at San Diego, and Nathan Tefft from the School of Public Health at the University of Washington, states:

“We explored financial conflicts of interest faced by doctors. Pharmaceutical firms frequently pay physicians in the form of meals, travel, and speaking fees. Over half of the 334,000 physicians in our sample receive payment of some kind. When a doctor is paid, we find that he is more likely to prescribe a drug of the paying firm, both relative to close substitutes and even generic versions of the same drug. This payment-for-prescription effect scales with transfer size, although doctors receiving only small and/or infrequent payments are also affected. The pattern holds in nearly every U.S. state, but it is strongly and positively related to regional measures of corruption.”

On this paper, a media report commented:

“The findings – based on recently released data that 12 companies have been forced to make public as a result of US regulatory settlements – will rekindle the debate over the limits of aggressive pharmaceutical marketing, which risks incurring unnecessarily costly medical treatment and causing harm to patients.”

A call for reform:

The first paper, as quoted above, titled “Breaking Up is Hard to Do” reiterates that even after decades, individual practitioner still remains the subject to undue influence of the pharmaceutical companies in this respect. It categorically points out:

“The powerful influence of pharmaceutical marketing on the prescribing patterns of physicians has been documented and has led to fervent calls for reform at the institutional, professional, and individual levels to minimize this impact.”

The rectification process has begun in America:

Interestingly, even in the United States, most physicians practice outside of academic institutions and keep meeting the Medical Representatives, accept gifts and drug samples against an expected return from the drug companies.

Many of them, as the paper says, have no other process to follow to become ‘pharma-free’ by shunning this hidden primitive barrier for the sake of better healthcare with lesser drug costs.

To achieve this objective, many academic medical centers in America have now started analyzing the existing relationship between doctors and the drug companies to limit such direct sales and marketing related interactions for patients’ interest.

This unconventional approach will call for snapping up the good-old financial transactional relationship model between the doctors and Medical Representatives of the Pharma players, who promote especially the innovative and more costly medicines.

An expensive marketing process:

The authors opine that this is, in fact, a very powerful marketing process, where the pharmaceutical players spend ‘tens of billions of dollars a year’. In this process more than 90,000 Medical Representatives are involved only in the United States, providing free samples, gifts along with various other drug related details.

The study reiterates that deployment of huge sales and marketing resources with one Medical Representative for every eight doctors in the United States, does not serve the patients interests in any way one would look into it, even in terms of economy, efficacy, safety or accuracy of information.

“But Don’t Drug Companies Spend More on Marketing?”

Yet another recent article, captioned as above, very interestingly argues, though the drug companies spend good amount of money on R&D, they spend much more on their marketing related activities.

Analyzing six global pharma and biotech majors, the author highlights that SG&A (Sales, General & Administrative) and R&D expenses vary quite a lot from company to company. However, in this particular analysis the range was as follows:

SG&A 23% to 34%
R&D 12.5% to 24%

SG&A expenses typically include advertising, promotion, marketing and executive salaries. The author says that most companies do not show the break up of the ‘S’ part separately.

A worthwhile experiment:

Removing the hidden barriers for better healthcare with lesser drug costs, as highlighted in the above “Breaking Up is Hard to Do” paper, the researchers from Oregon State University, Oregon Health & Science University and the University of Washington outlined a well conceived process followed by one medical center located in central Oregon to keep the Medical Representatives of the pharmaceutical companies at bay from their clinical practice.

In this clinic, the researchers used ‘a practice transformation process’ that analyzed in details the industry presence in the clinic. Accordingly, they educated the doctors on potential conflicts of interest and improved patient outcomes of the clinical practice. The concerns of the staff were given due considerations. Managing without samples, loss of gifts, keeping current with new drugs were the key concerns.

Based on all these inputs, various educational interventions were developed to help the doctors updating their knowledge of new drugs and treatment, even better, through a different process.

The experiment established, though it is possible to become “pharma free” by consciously avoiding the conflicts of interest, implementation of this entire process is not a ‘piece of cake’, at least not just yet.

Need for well-structured campaigns:

The researchers concluded that to follow a “pharma sales and marketing free” environment in the clinical practice, the prevailing culture needs to be changed through methodical and well-structured campaigns. Although, initiation of this process has already begun, still there are miles to go, especially in the realm of smaller practices.

One researcher thus articulated as follows:

“We ultimately decided something had to be done when our medical clinic was visited by drug reps 199 times in six months. That number was just staggering.”

Where else to get scientific information for a new drug or treatment?

The authors said, information on new drugs or treatment is currently available not just in many other forum, but also come with less bias and more evidence-based format than what usually are provided by the respective pharmaceutical companies with a strong motive to sell their drugs at a high price to the patients. 

The paper indicated that there are enough instances where the doctors replaced the process of getting information supplied by the Medical Representatives through promotional literature with monthly group meetings to stay abreast on the latest drugs and treatment, based on peer-reviews.

‘Academic detailing’:

In the process of ‘Academic detailing’ the universities, and other impartial sources of credible information, offer accurate information without bias, whenever sought for. In the United States, some states and also the federal government are reportedly supporting this move now, which is widely believed to be a step in the right direction.

Moves to separate sales and marketing of the drug industry from the practice of medicine:

As stated above, there are many moves now in the United States to ‘separate the sales and marketing influence of the drug industry from the practice of medicine’, especially in large medical teaching hospitals, as the paper highlights.

The study also reported that of the 800,000 physicians practicing in the United States only 22 percent practice in the academic settings and 84 percent of primary care physicians continue to maintain close relationships with the pharmaceutical companies.

Citing examples, the new report indicated various tangible steps that primary care physicians can possibly take to effectively mitigate these concerns.

Emerging newer ways of providing and obtaining most recent information on new drugs and treatment together with educating the patients will hasten this reform process.

A commendable move by the Medical Council of India:

Taking a step towards this direction, the Medical Council of India (MCI) vide a notification dated December 10, 2009 amended the “Indian Medical Council (Professional Conduct, Etiquette and Ethics), Regulations 2002″. This move was welcomed by most of the stakeholders, barring some vested interests.

The notification specified stricter regulations for doctors in areas, among others, gifts, travel facilities/ hospitality, including Continuing Medical Education (CME), cash or monetary grants, medical research, maintaining professional Autonomy, affiliation and endorsement in their relationship with the ‘pharmaceutical and allied health sector industry’. These guidelines came into force effective December 14, 2009.

With this new and amended regulation, the MCI, on paper, has almost imposed a ban on the doctors from receiving gifts of any kind, in addition to hospitality and travel facilities related to CMEs and others, from the pharmaceutical and allied health sector industries in India.

Moreover, for all research projects funded by the pharmaceutical industry and undertaken by the medical profession, prior approval from the appropriate authorities for the same will be essential, in addition to the ethics committee.

Although maintaining a cordial and professional relationship between the pharmaceutical industry and the doctors is very important, such relationship now should no way compromise the professional autonomy of the medical profession or any medical institution, directly or indirectly.

It is expected that the common practices of participating in private, routine and more of brand marketing oriented clinical trials would possibly be jettisoned as a pharmaceutical strategy input.

However, inability of the Indian regulator to get these guidelines effectively implemented  and monitored has drawn sharp flak from all other stakeholders, as many third party private vendors are reportedly coming up as buffers between the industry and the physicians to facilitate the ongoing illegal financial transactions, hoodwinking the entire purpose, blatantly.

No such government guidelines for the industry yet:

MCI under the Ministry of Health, at least, came out with some measures for the doctors in 2009 to stop such undesirable practices.

However, it is difficult to fathom, why even almost four years down the line, the Department of Pharmaceuticals of the Government of India is yet to implement its much hyped ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ for the entire pharmaceutical industry in India.

‘Physicians payment induced prescriptions’ – a global phenomenon:

Besides what is happening in China today with large pharma MNCs alleged involvement in bribery to the medical profession soliciting prescriptions of their respective drugs, world media keep reporting on this subject, incessantly.

For example, The Guardian in its July 4, 2012 edition reported an astonishing story. Since quite some time many pharmaceutical giants are being reportedly investigated and fined, including out of court settlements, for bribery charges related to the physicians.

In another very recent article titled “Dollars for Docs Mints a Millionaire” the author stated as follows:

“The companies in Dollars for Docs accounted for about 47 percent of U.S. prescription drug sales in 2011. It’s unclear what percentage of total industry spending on doctors they represent, because dozens of companies do not publicize what they pay individual doctors. Most companies in Dollars for Docs are required to report under legal settlements with the federal government.”

In India, deep anguish of the stakeholders over this issue is also getting increasingly reverberated all across, without much results on the ground though. It has also been drawing attention of the patients’ groups, NGOs, media, Government and even the Parliament of the country. 

Another article titled, “Healthcare industry is a rip-off” published in a leading business daily of India states as follows:

“Unethical drug promotion is an emerging threat for society. The Government provides few checks and balances on drug promotion.”

Physician Payment Sunshine Act of 2010:

To partly address this issue under President Obama’s ‘Patient Protection Affordable Care Act’, ‘Physician Payment Sunshine Act’ came into force in the United States in 2010. 

Under this Act, any purchasing organization that purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply or manufacturer of a covered drug, device, biological, or medical supply operating in the United States, or in a territory, possession, or commonwealth of the United States is required to publicly disclose gifts and payments made to physicians.

Penalty for each payment not reported can be upto US$ 10,000 and the penalty for knowingly failing to submit payment information can be upto US$ 100,000, for each payment.

Centers for Medicare and Medicaid Services (CMS) has already released their ‘Physician Payment Sunshine Act’ reporting templates for 2013. The templates apply for reports dated August 1, 2013 – December 31, 2013.

Should the Government of India not consider enacting similar law in the country  without further delay?

Conclusion:

That said, these well-researched papers do establish increasing stakeholder awareness and global concerns on the undesirable financial influence of pharma players on the doctors. Product promotion practices of dubious value, especially in the name of ‘Continuing Medical Education (CME), seem to strongly influence the prescribing patterns of the doctors, making patients the ultimate sufferer.

The studies will help immensely to establish that achieving the cherished objective of a ‘pharma sales and marketing free’ clinic is not only achievable, but also sustainable for long.

The barriers to achieving success in this area are not insurmountable either, as the above article concludes. These obstacles can easily be identified and overcome with inputs from all concerned, careful analysis of the situation, stakeholder education and identifying most suitable alternatives.

Thus, I reckon, to effectively resolve the humongous ‘physician payment induced prescriptions’ issue for the sole benefit of patients, it is about time for the pharmaceutical players to make a conscientious attempt to shun the ‘road much travelled, thus far, with innovative alternatives. However, the same old apprehension keeps lingering:

“Will the mad race for buying physicians’ prescriptions in cash or kind, much against patients’ interest, continue to remain a global (dis)order, defying all sincere efforts that are being made today?  

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.