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

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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.

Honing Patient Outcomes With WHDs

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On November 01, 2019, San Francisco-based Fitbit, Inc. announced that it has entered into a definitive agreement to be acquired by Google LLC for approximately US$ 2.1 billion. Many believe, though, the value of Fitbit lies in the health data that its wearables capture for its large base of users.

According to the CEO of Fitbit, currently the Fitbit brand supports more than 28 million active users around the globe who rely on these wearable products ‘to live a healthier, more active life.’ With Google’s resources and global platform, Fitbit will be able to accelerate innovation in the wearables category, scale faster, and make health even more accessible to everyone, he added.

The article – ‘The Real Reason Google Is Buying Fitbit,’ published in the Time magazine on November 04, 2019 makes some interesting points, such as the following:

  • The fast-growing healthcare tech space could be worth US$24 billion by 2020, says an estimate from Statista.
  • Although, Google has been working on cardiovascular health, diabetes and more, it hasn’t been publicly pushing healthcare as a business proposition, just yet.
  • Whereas, Google’s rivals, most notably Apple, have embraced healthcare as the next big battleground in the tech world, attracted by the promises of big profits for those who can help simplify a byzantine healthcare system.

Nonetheless, the Fitbit acquisition would facilitate Google’s entry into the Wearable Health Devices (WHDs) market in a big way, alongside other big players, such as, Apple and Samsung.

Driven by the most likely scenario of increasing usage and usefulness of WHDs, several pharma players are sniffing huge underlying commercial opportunity in this space, alongside being demonstrably patient-centric. Thus, my today’ article will deliberate whether or not WHDs will be able to offer a cutting edge to innovative drug marketers, by continually honing patient outcomes. Let me initiate this discussion by fathoming the importance of WHDs in the fast transforming digital world.

The importance of WHDs in the digital world:

‘Mary Meeker‘s 2019 Internet Trends Report’ highlights, about 51 percent of the global population is now connected to the internet, with the majority of users based in China, India and the United States. However, global internet user growth has slowed down by 6 percent and it’s becoming increasingly harder to get the rest of the world online.

In this background, especially - ‘As patients become more involved in making decisions about their health care, research shows, the result is increased satisfaction and improved health outcomes.’Consequently, the report spotlights healthcare digitization where consumer adoption of digital health tools is increasing rapidly. Some of the top areas, in terms of their speed of adoption, were listed as follows:

  • Online Health Information
  • Online Provider Reviews
  • Mobile Tracking
  • Wearables
  • Live Video Telemedicine

This gives a sense of how fast the WHDs are gaining importance for the consumers. Interestingly, Intouch Group also points out that wearables are now being used more to manage a diagnosis rather than just fitness trackers. Adding further, it pointed out – ‘Apple’s ResearchKit is an example of what CEO Tim Cook calls the “democratization of healthcare,” in that it provides health data directly to consumers so they can manage their health.’

A recent study on the scope of wearables: 

The scope of WHDs was aptly corroborated in a recent article – ‘The Rise of Wearable Technology in Health Care,’ published in the JAMA Network Open on February 01, 2019. The paper concludes, the general principle of commercially available ubiquitous wearable computers bodes well for our future ability to measure, track, and understand patient physiological data and behavior both in the hospital and at home.

The ability to capture such data, then applying machine learning to get the evolving health trends and sending alerts to patient accordingly – nurses, and physicians are instantaneously getting empowered to deliver patient outcomes. The fact that the alert can come easily via the patients’ smartphones that a significant part of the global population now carries with them, leading to further democratization of health care.

The Economist  also predicted, by 2020 – 80 percent of the adult population of the world would have a smartphone in their pocket. Therefore, this development opens up an entirely new world of real-time data acquisition, monitoring, and intervention, the paper underscored.

Giving a relevant example, it highlighted: ‘On December 6, 2018, Apple rolled out a software upgrade that turns the Apple Watch Series 4 into a personal electrocardiogram.’ The researchers further added, while WHDs’ fidelity may not yet exactly match medical-grade monitors and devices, these are “good enough” coupled with around-the-clock capabilities, real-time data capture, storage, and analytics and seem likely to provide real value.

The opportunities with WHDs:

Both from the health and business perspectives, WHDs are opening new vistas of opportunities for all stakeholders in the healthcare space, such as, patients, doctors, care providers and also pharma companies. This was enunciated in several studies, such as one, titled ‘Wearable Health Devices – Vital Sign Monitoring, Systems and Technologies,’ published by Sensors (Basel, Switzerland) on July 25, 2018.

This paper also reiterated: ‘Wearable Health Devices (WHDs) are increasingly helping people to better monitor their health status both at an activity/fitness level for self-health tracking and at a medical level providing more data to clinicians with a potential for earlier diagnosis and guidance of treatment. The technology revolution in the miniaturization of electronic devices is enabling to design more reliable and adaptable wearables, contributing to a world-wide change in the health monitoring approach.’

Thus, a big excitement is currently palpable around the technology related to WHDs. Many more opportunities are expected to unfold for continuation of the ascending trend. With the entry of big global tech giants such as, Apple and now Google, besides scores of small startups, WHDs of many types have started entering into the healthcare, carrying a promise to improving outcomes and creating a unique patient experience in the disease treatment process.

Improves outcomes, creates a unique disease treatment experience:

Echoing many other experts in this area, I also believe that WHDs have covered a lot of ground by now – expanding its usage from fitness trackers to diagnosis of disease and then monitoring the progress both during and after treatment. Current usages of WHDs are mostly for non-infectious chronic diseases, such as diabetes, cardiovascular conditions, sleeping disorders, obesity and treatment compliance, besides others. The list is gradually expected to expand.

Apparently, encouraged by this trend, more pharma players are now moving into this area for significant brand value for augmentation through better patient outcomes – apace with providing a unique disease treatment experience for suffering individuals.

The scope in India:

As WHDs have a close link with both Internet and Smartphone penetration, let me try to weigh the potential of the wearables, in view of the current status of both in the country.

According to the India Internet 2019 Report by Internet and Mobile Association of India (IAMAI), the following three points are indeed noteworthy, besides others:

  • With 451 million monthly active internet users at the end of financial year 2019, India is now second only to China in this regard.
  • Urban India with 192 million users had almost the same number of users as rural India. However, in terms of percentages or penetration, given the disparity of population distribution in urban and rural India, urban India had a considerably higher penetration level.
  • In rural India, a sizable portion does not have access to the Internet, and provides a huge opportunity for growth which will contribute to an increase in the overall Internet population over the next few years, it said.

Similarly, according to the Statista report, for 2017, the number of smartphone users in India was estimated to reach 299.24 million, with the number of smartphone users worldwide forecast to exceed 2.3 billion users by that time, and was projected to be nearly 2.7 billion by 2019.

These numbers speak for themselves on the underlying opportunities of WHDs – both globally and locally. Accordingly, large pharma players have already started teaming up to deliver better patient outcomes, leveraging the value of WHDs.

Pharma players teaming up to deliver better patient outcomes with WHD:

There are several such examples. Nevertheless, to illustrate the point, let me cite one such recent instance of Abbott Laboratories announcing a deal on February 20, 2019 with Novo Nordisk to make diabetes management easier by linking technologies of the two companies. The deal will allow integration of insulin dose data for Novo Nordisk’s pre-filled and connected pens with its ‘FreeStyle’ Libre mobile app and cloud-based system.

‘Abbott’s ‘FreeStyle’ Libre Continuous Glucose Monitoring (CGM) system will read glucose levels through a sensor that can be worn on the back of the upper arm eliminating the need for routine finger pricks. Through the FreeStyle LibreLink app users can capture and view their real-time glucose levels, their eight-hour glucose history, and how their glucose is currently changing on their smartphone.’

Yet another report highlighted, ‘Google sister-company Verily is teaming with big pharma on clinical trials.’ On May 21, 2019, the company announced strategic alliances with the pharmaceutical companies Novartis, Sanofi, Otsuka and Pfizer to help it move more deeply into the medical studies market. The goals for Verily, and its pharma partners, are to reach patients in new ways, make it easier to enroll and participate in trials, and aggregate data across a variety of sources, including the electronic medical record or health-tracking wearable devices,’ the report emphasized.

Conclusion:

It seems clear that in the rapidly transforming digital world, many drug companies are realizing the criticality of making their business operations sine qua non with the evolving trend is essential. This is not just for the organization progress, but also for long-term survival of the business. In the midst of this exciting technological environment, the potential value of WHDs to deliver better patient outcomes is being brought to the fore, primarily by the pure tech companies.

Figuring out the magnitude of the new opportunity, several pharma companies have thrown their hats in the ring, primarily in the form of collaborative deals. This ushers in a new phase in the healthcare space. Mostly because, such initiatives will have to be patient-centric for providing a unique patient experience with the drugs, in the disease treatment process. As India too, is taking rapid strides for penetration of digital technology in its ‘Health for All’ initiatives, the use of WHDs for better and cost-effective patient outcomes isn’t a pipe dream, any longer.

The evolving scenario, therefore, opens yet another door for the pharma players to grow their business, not just with drugs offering differential value, but also by making even a ‘me-too’ drug perform better, leveraging the potential of WHDs, effectively. From this perspective, continuously honing patient outcomes with WHDs, appears to be a unique tool for pharma marketers to make use of – in search of 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.

 

Opioid Crisis: A Looming Threat To India?

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A serious, but a typical health crisis that has shaken America, is now, apparently, in search of its prey in India – a soft target to ignite a raging fire of misuse or abuse of prescription drugs of addictive in nature. That India could probably be the next victim of this menace, is now being widely discussed and reported in the international media, though not so much in India, itself.

The January 2019 communique of the National Institute of Drug Abuse spotlights: ‘Every day more than 130 people in the United States die after overdosing on opioids.’ Whereas, in 2017, more than 47,000 Americans, among 1.7 million suffering people, died as a result of an Opioid overdose. Snowballing effect of Opioids addiction commenced over a couple of decades ago and includes – both prescription pain relievers and synthetic Opioids, such as fentanyl, among others.

The health menace of this humongous dimension is not only jeopardizing public health, but also impacting the social and economic welfare, work productivity, besides drug addiction related criminal behavior of an increasing number of addicts.

In this article, exploring the factors – that not just ignited, but fueled this fire, I shall try to explain why India could be a fertile ground for another opioid epidemic. The key intent is to thwart this menace without further delay, learning from the ‘Opioid crisis’ in the United States. Moving towards that direction, I begin with a brief description of the genesis of this crisis, primarily to ensure that all my readers are on the same page to feel the gravity of the situation.

The genesis of Opioid crisis:

The terms – ‘Opioid epidemic’ or ‘Opioid crisis’are generally referred to rapid increase in consumption of prescription and nonprescription Opioid drugs in America that began in the late 1990s. It is noteworthy, until the mid-1980s and early 1990s, physicians seldom prescribed opiates because of the fear of addicting patients. This was established in several studies, such as, the July-August 2016 Article, titled ‘Drug Company Compensated Physicians Role in Causing America’s Deadly Opioid Epidemic: When Will We Learn?’

In the ninety’s, as the above paper indicates, some “medical experts and thought leaders led by the neurologist and pain specialist Russell Portenoy, MD, proclaimed that the risks of addiction to Opioids were minimal and that not treating pain was cruel and even amounted to medical negligence.” Incidentally, Russell Portenoy was at that time known as the “King of Pain” and was the Chairman of Pain Medicine and Palliative Care at Beth Israel Hospital in New York.

The paper also articulated, “Portenoy and his acolytes wrote articles and gave lectures to physicians about the safety of narcotics. They repeatedly cited a study by Porter and Jick in ‘The New England Journal of Medicine’ that stated that only one percent of patients treated with narcotics became addicted.” It is a different matter, as the authors indicated, the above trial was ‘not a controlled study at all. It consisted of a short 101-word one paragraph letter to the editor.’

Understandably, the rapid spread of Opioid use in America commenced on the following years. As The author highlighted: “To this day in most American hospitals, nurses on their daily rounds, ask patients to rate their pain on a scale of one to ten and then may administer a narcotic accordingly.”

HHS corroborates the fact:

In line with the finding of the above paper, the U.S. Department of Health and Human Services (HHS) traces the origin of the U.S. Opioid Epidemic in the late 1990s. When, asHHS also reiterated, ‘pharmaceutical companies reassured the medical community that patients would not become addicted to opioid pain relievers.’ Presumably, the general image of the pharma industry not being as questionable as today, ‘health care providers began to prescribe them at greater rates,’ – HHS further noted.

Thereafter, all hell broke loose, as it were.With increased prescriptions of Opioid medications, the widespread misuse of both prescription and non-prescription Opioids started taking its toll. Obviously, it happened as the prescribers were not as cautious and restrictive and concerned about prescribing Opioids because of their addictive nature, as they were before 1990s. It seems unlikely that astute medical practitioners won’t be able to fathom the devastating health impact of such highly addictive medications on the users.

America had to declare the Opioid crisis as public health emergency: 

In 2017 HHS declared Opioid crisis as a public health emergency, announcing a strategy to combat this epidemic. Separately, in October 2017, President Trump also declared the same as the ‘worst drug crisis in U.S. history’.One can sense this Presidential level urgency from the recent report of The Washington Post. It emphasized - ‘America’s largest drug companies saturated the country with 76 billion oxycodone and hydrocodone pain pills from 2006 through 2012, as the nation’s deadliest drug epidemic spun out of control.’

The above information comes from a database maintained by the Drug Enforcement Administration that tracks the path of every single pain pill sold in the United States – from manufacturers and distributors to pharmacies in every town and city. The data would provide an unprecedented look at the surge of legal pain pills that fueled the Opioid epidemic, resulting in nearly 100,000 deaths from 2006 through 2012, as the article highlighted.

In view of this, and also looking at the chronology of the genesis of this crisis, it is worth exploring the role of pharma companies in triggering this health hazard in America.

The role of pharma companies in the crisis: 

That there is, apparently, a role of some big pharma players in the Opioid crisis was widely reported by the international media. One such article titled, ‘Big Pharma Is Starting to Pay for the Opioid Crisis. Make Those Payments Count,’ was publishesby The New York Times, on August 28, 2019.

It said: ‘As innumerable court documents and investigations have shown, Opioid makers, including Purdue and Johnson & Johnson, routinely and knowingly misled the public about their products. They played down the risks of addiction, insisting that their drugs were safe and, if anything, underutilized. And they combated growing concerns with aggressive lobbying and public relations campaigns.’

The September 01, 2019 article titled – ‘America’s Opioid catastrophe has lessons for us all, about greed and racial division’, published in The Guardian went a step forward. Explaining the reason for the situation to attain a ‘crisis’ stage, it said, ‘big pharma saw huge profits in medicalizing the social stress of the white working class.’ Thus, the question that comes up, is there any strong and credible evidence to associate Opioid crisis with pharma marketing?

Association of Opioid crisis with pharma marketing:

Several reports point towards a possible pharma-doctor nexus for the Opioid crisis. One such evidence is provided by the same  July-August 2016 Article, as quoted above. The paper said:‘Recently and belatedly, Portenoy has backtracked and admitted he was wrong about the addictive properties of Opioids.’ He was quoted in the article saying: “I gave innumerable lectures in the late 1980s and ‘90s about addiction that weren’t true.”

Another original investigation report in this regard, titled ‘‘Association of Pharmaceutical Industry Marketing of Opioid Products With Mortality From Opioid-Related Overdoses’, was published in JAMAon January 18, 2019. The paper concluded:‘In this study, across US counties, marketing of Opioid products to physicians was associated with increased Opioid prescribing and, subsequently, with elevated mortality from overdoses. Amid a national Opioid overdose crisis, reexamining the influence of the pharmaceutical industry may be warranted.’

The article also indicated: ‘Recent data suggest that when physicians receive Opioid marketing, they subsequently prescribe more Opioids.’ The researchers pointed out:‘Amid a worsening Opioid crisis, our results suggest that industry marketing to physicians may run counter to current efforts to curb excessive Opioid prescribing.’

Again, the same September 01, 2019 article, published in The Guardian, also stresses– ‘The relationship between big pharma and US doctors can only be described as corrupt.’ Quoting the official figures, it highlighted: ‘The total paid to doctors and hospitals by drug companies was more than $9bn. Unsurprisingly, the greater the payments, the more willing doctors were to prescribe Opioids.’

The India’s tryst with Opioid drugs:

As many would know, India has remained for a long time one of the largest Opioid medicine producers in the world. However, most of the country’s population had a restricted access to Opioid pain relief drugs.

This was because, the International Narcotics Control Board, established in 1968, and the Narcotic Drugs and Psychotropic Substances Act of 1985 ‘codified the bureaucratic thicket for any doctor who wanted to prescribe opioid painkillers. Physicians feared fines, jail sentences and losing their medical license if they skirted regulations.’

The amendment came in 2014:

According to reports, the need for pain relief being “an important obligation of the government,” the Narcotic Drugs and Psychotropic Substances Act, was amended in 2014, creating a class of medicines called the “essential narcotic drugs.” The list of which includes, morphine, fentanyl, methadone, oxycodone, codeine and hydrocodone. Alongside, the conditions for bail in drug offenses will be relaxed and the mandatory death penalty for those previously convicted of certain offenses will be revoked.This is expected to create a better balance between narcotic drug control and the availability of Opioid drugs, for beneficial use of patients.

The flip side – a looming threat?

So far so good. Nevertheless, another article – ‘How big pharma is targeting India’s booming Opioid market,’ appeared in The Guardian on August 27, 2019, shows the flip side of this development. It says, as India loosens its stringent narcotics laws, ‘American pharmaceutical companies – architects of the Opioid crisis in the United States and avid hunters of new markets – stand at the ready to fuel that demand.’

Many are truly concerned about it, especially in a country like India, where any medicine can be procured over the counter, hoodwinking robust drug laws. Thus, as the above article adds, ‘a looming deluge of addictive painkillers terrifies some Indian medical professionals, who are keenly aware that despite government regulations most drugs are available for petty cash at local chemist shops.’

Providers of pain management are increasing, so also self-medication:

Today, ‘pain management’ as a specialty treatment, can be seen in many hospitals of the country. In tandem – apparently, ‘at the insistence of the professional societies that accredit hospitals in India, nurses and doctors are now encouraged to assess pain as a “fifth vital sign“, along with pulse, temperature, breathing and blood pressure.’ Besides, as The Guardian article of August 27, 2019 also noted, ‘General practitioners have started prescribing these drugs.’

Yet another important point to note, according to studies, one of the most common reasons for self-medication is for pain – 18.34 percent, where self-medication is done with nonsteroidal anti-inflammatory drugs in 49.4 percent of cases. Keeping pace with this trend, most generic pharma companies are having pain management product in their brand portfolio, unlike a couple of decades ago.

Early signs of drug companies’ special marketing activities:

There are many examples. But I shall quote The Guardian article again to drive home this point. The paper talks about hints of ‘American pharma’s fingerprints’ in a glass cabinet in the waiting room of a famous clinic in Delhi. Some of these include ‘awards from Johnson & Johnson honoring the doctor for symposia on pain management; a plaque for “his valuable contribution as a speaker” about tapentadol, an Opioid marketed by Johnson & Johnson in 2009. The dispensing counter does a brisk business in Ultracet, branded tramadol tablets made by a Johnson & Johnson subsidiary.’

Alongside, another interesting point is peeps in – the drugs, which are now commonly prescribed for chronic pain were first approved for use by cancer patients. ‘One of the first formulations of fentanyl, for example, was a lollipop because chemotherapy left cancer patients too nauseated to eat. In India, pain physicians now prescribe fentanyl patches to patients with chronic muscular pain.’

Every year, more of such drugs are coming to market. Many chemists, hospitals and medical shops are also acquiring requisite licenses for keeping these drugs. Curiously, Opioids are available in not just oral, but injectable, patches and syrups – the article noted.

Conclusion:

There are many striking similarities between the developments that preceded the American Opioid crisis and the emerging scenario of the same in India. One such is, its onset in America was in the late 1990s, with the regulatory relaxation in introducing Opioid drugs. However, the first announcement of the full-blown crisis on the same, took a couple of decades to come.

In India, the regulatory relaxation for some Opioid drugs came in 2014, and now its 2019. Thus, it’s possibly too early to even track, in which direction it is moving. However, given the prevailing overall healthcare scenario in India, the concern remains palpable. The decision makers, hopefully, would consider putting in place effective checks and balances, taking a leaf from the American Opioid epidemic. The measures should include, among others, effective implementation of legal and regulatory provisions; making health care delivery systems robust and transparent; protecting vulnerable patients from rampant and irresponsible self-medication, besides promptly addressing general concerns with pharma marketing practices.

The whole process should be aimed at benefitting the deserving patients, suffering from excruciating pain, while minimizing Opioid drug misuse or abuse. There should not be any repetition of human sufferings on this score, like what people are now witnessing in America. Effective action from all concerned – right from now, will decide whether or not Opioid crisis is a looming threat that India can successfully neutralize.

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 India in The Eye of The AMR Storm?

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‘With 700,000 people losing battle to antimicrobial resistance (AMR) per year and another 10 million projected to die from it by 2050, AMR alone is killing more people than cancer and road traffic accidents combined together.’ This was highlighted in the Review Article, ‘Antimicrobial resistance in the environment: The Indian scenario,’ published in the Indian Journal of Medical Research (IJMR), on June 03, 2019.

The article further noted, ‘AMR engendered from the environment has largely remained neglected so far,’ which has a snowballing effect. Illustrating the enormity of its impact, the researchers recorded: ‘Economic projections suggest that by 2050, AMR would decrease gross domestic product (GDP) by 2-3.5 percent with a fall in livestock by 3-8 percent, costing USD100 trillion to the world.’

Besides International media, fearsome consequences of AMR are also being highlighted by the Indian media from time to time. For example, on November 21, 2018, a leading national business daily carried an apt headline: ‘India in the firing line of antimicrobial resistance.’ More intensive coverage of such nature for this public menace, would hopefully appeal to the conscience of all those who can meaningfully address this situation, especially the government.

Against this backdrop, I shall explore in this article, whether India is really in the eye of this AMR storm, which is posing an unprecedented threat to many lives, perhaps more in India. 

India is being called the AMR capital of the world: 

Analyzing the emerging research data in this area, India was referred to as ‘the AMR capital of the world,’ in the 2017 Review Article, title ‘Antimicrobial resistance: the next BIG pandemic.’ Curiously, besides umpteen number of published papers documenting this scary development, very few enlightened individuals would dare to push an argument to the contrary. Whereas, besides framing a policy document on AMR,nothing much is changing in India on this score. This is happening, even when it is evidenced that a gamut of the most powerful antibiotics, are not working against many deadly bacteria. Added to it, India still doesn’t have a public database that provides death due to AMR.

Are adequate resources being deployed to fight the menace:

Today one would witness with pride that India’s ‘Chandrayaan 2’ lunar mission is moving towards the Moon’s south polar region, where no country has ever gone before. At the same time, despite AMR threat, India’s budgetary allocation for health in 2018-2019, reportedly, shows a 2.1 percent decrease of the total Union Budget from the 2.4 percent in 2017-2018.

It is interesting to note that India: ‘Despite being the world’s sixth largest economy, public health spending has languished at under 1.5 percent of GDP, one of the lowest rates in the world. For comparison, the United Kingdom shelled out 9.6 percent of its GDP in 2017 on health. The United States’ health expenditure is 18 percent of GDP.’

‘Ayushman Bharat’ and health care infrastructure:

Recently lunched public health program - Ayushman Bharat, although is not a Universal Health Care (UHC) program, it has targeted to cover ‘less than half the population and excluding 700 million people’. While giving a thumbs-up to this initiative, if one looks at the overall health infrastructure in India to make it possible as intended, it may not encourage many.

To illustrate this point, let me quote only the salient points, as captured in a 2018 study, published in the British Medical Journal, as follows:

  • The total size of health workforce estimated from the National Sample Survey (NSS) data was 3.8 million as of January 2016, which is about 1.2 million less than the total number of health professionals registered with different councils and associations.
  • The density of doctors and nurses and midwives per 10,000 population is 20.6 according to the NSS and 26.7 based on the registry data.
  • Health workforce density in rural India and states in eastern India is lower than the WHO minimum threshold of 22.8 per 10,000 population.
  • More than 80 percent of doctors and 70 percent of nurses and midwives are employed in the private sector.
  • Approximately 25 percent of the current working health professionals do not have the required qualifications as laid down by professional councils, while 20 percent of adequately qualified doctors are not in the current workforce.

The intent to deliver health care as announced by various governments from time to time is good. But, the available health infrastructure to deliver these meaningfully are grossly inadequate, creating a huge apprehension among many. This is not just because of the grossly inadequate number of hospitals, doctors, nurses and paramedics, but also their even uneven spread in the country. The cumulative impact of these, fueled by corruption, ‘missing doctors, ill-equipped health professionals, and paucity of required funds’ continue creating a humongous problem for the public, at large, to get affordable health care.

At the same time, there is ‘a serious lack of new antibiotics under development to combat the growing threat of antimicrobial resistance.’ Imagine, a situation when India gets caught in the eye of the AMR storm and imagine the consequences of that, as you deem appropriate.

Lack of new antibiotics under development to combat AMR:

The World Health Organization (WHO) report - ‘Antibacterial agents in clinical development – an analysis of the antibacterial clinical development pipeline, including tuberculosis’, launched on September 20, 2017 shows ‘a serious lack of new antibiotics under development to combat the growing threat of antimicrobial resistance.’

It further reported: ‘Most of the drugs currently in the clinical pipeline are modifications of existing classes of antibiotics and are only short-term solutions.’ The report also found, very few potential treatment options for those antibiotic-resistant infections identified by WHO as posing the greatest threat to health, including drug-resistant tuberculosis which kills around 250 000 people each year.

Thus, the point to ponder simultaneously is, whether there is any decline in global investments for antibiotic research, both by the drug industry and the public funders.

Declining investment on new antibiotic R&D: 

As stated in the May 2016 paper, titled ‘Tackling Drug-Resistant Infections Globally. As the report indicates: ‘The UK Prime Minister commissioned the Review on Antimicrobial Resistance to address the growing global problem of drug-resistant infections. It is chaired by Jim O’Neill and supported by the Wellcome Trust and UK Government, but operates and speaks with full independence from both.’

The report acknowledges that new antibiotic research and development has been suffering from decades of under-investment by companies and governments. The reason being, antibiotic discovery and development are no longer an attractive proposition for commercial drug developers, for a key fundamental reason:

And this is, lack of a dependable, commercially-attractive market for antibiotics that meet large unmet medical needs. As a result, the volume of sales of a such new antibiotics will be low, and restricted only to multi-drug resistant bacteria. Otherwise, older and cheaper antibiotics will still work against most other infections. In that scenario, patented new antibiotics will have to compete with generics, keeping the price low. This combination of price pressure and low volumes makes antibiotics unattractive as a commercial proposition for many drug developers.

Which is why, as the report says: ‘Less than 5 percent of venture capital investment in pharmaceutical R&D between 2003 and 2013 was for antimicrobial development.’ Against total venture capital investment of USD 38 billion in pharmaceutical R&D, antimicrobial venture capital investment was mere USD 1.8 billion, during the same period. Coming back to India specific concerns, let’s have a look at the sociocultural issues in the country, associated with AMR.

Sociocultural issues are fueling the fire:

Understandably, the AMR problem remains intricately intertwined with a number of sociocultural issues of India. It has been established in several studies that social level, socioeconomic and socio-cultural status can play a significant role in the health status of people. Most research done on this subject indicates that higher level of socioeconomic classes reflects at a higher level of health and longevity. Much of this comes from the fact that there is a higher level of education and health care that is available for ‘this class level’.

Sociocultural issues in India also includes, poor hygienic practices, inadequate clean water and good sanitation facilities across the country, besides improper implementation and lack of good governance of health policies, rules and regulations. These factors are also aggravating the AMR problems in the country, as stated in the article, titled ‘‘Public Health Challenges in India,’ published in the Indian Journal of Community Medicine, in its April-June 2016 issue. Which is why, just addressing the indiscriminate use of antibiotics and restricting its wide consumption, aren’t not enough, any longer.

Is India in the eye of the AMR storm?

‘Antimicrobial resistance (AMR) has emerged as a major threat to public health estimated to cause 10 million deaths annually by 2050. India carries one of the largest burdens of drug-resistant pathogens worldwide.’ This was highlighted in the research paper, titled ‘Antimicrobial resistance: Progress in the decade since the emergence of New Delhi metallo-β-lactamase in India’, published in the Indian Journal of Community Medicine, on March 12, 2019.

The article noted, ‘AMR has been identified as a global health threat with serious health, political, and economic implications.’ The paper concluded with a serious note, which is worth taking note of. It found, the full throttle efforts to tackle the AMR challenge in India still requires significant efforts from all stakeholders. It underscored, ‘Despite the adoption of a national policy and significant activities already underway, progress is limited by a lack of clear implementation strategy and research gaps.’ 

Suggested areas of focus in India:

As ‘the Sword of Damocles’, in the form of AMR, hangs over the head of Indian population, there are certain important measures that the country can definitely take to contain AMR, whereas some other critical ones will be challenging to roll out, immediately.

It is unlikely, during this period India will have the requisite wherewithal to focus on discovery and development of new antibiotics to tackle AMR. Similarly, only framing rules and regulations for doctors, patients, dispensing chemists or hospitals to prevent antibiotic misuse, which are not persuasively yet strongly implemented, won’t also yield desired results. Nevertheless, efforts must continue for their effective compliance.

That said, what the country can seriously focus on, sans much constraints, is on taking collective measures in resolving some of the crucial but intimately associated sociocultural issues, with all sincerity and precision. A few of these important areas include, intense public awareness campaigns on the growing threat to life due to AMR, clubbing the benefits of availing good sanitation facilities, hygienic lifestyle and everyday practices.

Moreover, misuse of antibiotics in poultry, animal farming and agriculture should be curbed. Alongside, mass vaccination program for prevention of bacterial and viral infections, should be made available all over the country. Monitoring of the incidence of death due to AMR, on an ongoing basis, is another practice should also feature in the must-do list, providing access to this database to public. Responding meaningfully to International coalition for country-specific action, is also very important. To attain this goal a healthy socioeconomic environment needs to be encouraged, with corruption free efficient governance.

Conclusion:

That India is in the eye of the AMR storm, can’t be wished away any longer. Thus, the fight against AMR will need to be a well-orchestrated one, engaging all stakeholders as partners. The private sector should also actively participate in the AMR awareness programs under public–private partnership (PPP) or through Corporate Social Responsibility (CSR) initiatives.

The whole process should be backed by a creative strategy, having buying-in from all concerned, but spearheaded by the government. That’s the minimum that, I reckon, should happen when the country is in the eye of the impending AMR storm.

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.

 

The Challenge of Holistic Value Creation With Pharma M&A

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Two mega deals, right at the dawn of 2019 gave a flying start to Merger & Acquisition (M&A) activities, in search of inorganic growth, by some large pharma companies. The two biggest ones are Bristol-Myers Squibb’s (BMS) USD 74 billion buyout of Celgene, and AbbVie’s USD 63 billion purchase of Allergan, as announced on January 03, 2019 and June 25, 2019, respectively. However, overall in the second quarter of 2019, there were, reportedly, only 22 deals – ‘the smallest quarterly deal count for at least a decade.’

As a strategic option for greater value creation to drive growth, M&A is being actively considered over a long period of time. The key focus of such value creation for the company remains primarily on enriching the pipeline of New Chemical or Molecular Entities (NCE/NME) for revenue synergy, besides cost synergy. This is understandable. But, for various reasons, alongside, a key question also comes up for debate – is the core purpose of such value creation to drive companies’ growth, primarily with more number new drugs, sustainable? The query assumes greater relevance in the evolving new paradigm. This is because, a basic shift is taking place in the core organizational purpose of value creation.

Thus, it appears, the nature of value creation through M&A would also matter as much. Can it still remain a drug company’s financial health centric, any longer? Should the M&A initiatives also not take under their wings, the value-offerings expected by patients from a drug company – beyond innovative pills? Would a holistic value creation through M&A would now be the name of the game? If so, how?  The discussion of my today’s article will revolve around these questions. Let me initiate the deliberation by recapitulating the key motivation behind M&A initiatives of the drug industry.

A key motivation behind the M&A initiatives in the drug industry:

While recapitulating one of the key motivations behind pharma M&As, let me refer to some interesting and recent studies, such as, the 2019 paper of McKinsey titled, ‘What’s behind the pharmaceutical sector’s M&A push.’ It also acknowledges, the use of M&A to bolster drug innovation is unlikely to change any time soon.

That many drug companies actively pursue the M&A option as a game changer for inorganic growth, is vindicated by the recent big deals, as quoted above. Since early 2000 and before, the companies that made the biggest deals to create new value synergies with, have been paying heavy deal premium to enrich their new product pipelines. Quite often it includes several new and emerging classes of drugs, as acquisition targets.

This also gets corroborated in the Press Release of the 2019 BMS deal, which says: ‘The transaction will create a leading focused specialty biopharma company well positioned to address the needs of patients with cancer, inflammatory and immunologic disease and cardiovascular disease through high-value innovative medicines and leading scientific capabilities.’

Lesser yield of traditional pharma M&A than the broader market:

This was emphasized in the June 06, 2019 article, published in The Washington Post, titled ‘Big Pharma Has to Bet Big on M&A. Investors Don’t.’ The analysis found, the returns from the big pharma deals ‘don’t look as good compared to the broader market’, although for very patient investors many of these have resulted in longer-term gains. To illustrate this point, the paper pointed out: ‘Of the eight biopharma deals worth more than USD 40 billion that closed in the last 20 years, only one delivered better returns than the S&P 500 five years after it closed.’

Naming Merck & Co..’s USD 47 billion acquisition of Schering-Plough Corp. in 2009, the researcher justified: ‘That deal is arguably something of an accidental winner. Long-term success didn’t come from any of the products that Merck targeted in the merger; instead, an afterthought of an antibody that was initially set to be sold off became Keytruda, a cancer drug that’s projected to generate USD 15 billion in sales in 2021.’

Innovative product launches no longer a holistic value-creation for patients: 

Thus, unlike yesteryears, enriching new and innovative product pipeline through M&A won’t serve the key purpose of value-creation for patients to treat deadly diseases in a holistic way. The primary reason for the same was articulated in the Deloitte Paper titled, ‘Disruptive M&A: Are you ready to define your future?’ The article emphasized: ‘The confluence of technological change, shifting customer preferences, and convergence across sectors is redesigning how products and services are developed, delivered, and consumed.’

Thus, mere acquisitions of innovative product portfolios, intended to provide better treatment choices for patients, may not meet the holistic needs of consumers’ while going through the disease treatment process. In depth understanding of such preferences with all associated nuances, is absolutely essential in today’s complex business scenario. Which is why, it calls for avant-garde type or ‘disruptive M&As’, that can help alter the business growth trajectories, making the disrupted company disrupt the competitive space, being game changers of the industry.

Calls for avant-garde type or disruptive pharma M&As:

Today, it’s crucial for any drug company to create a unique treatment experience for patients. This is emerging as a pivotal factor for the success of a brand.

Even most innovative products will need to be supported by disruptive back-office technology for market success. Thus, acquisition of disruptive technology to effectively augment the brand value delivery process is equally important, in tandem with enrichment of new product pipeline. This is expected to emerge as a critical driver in pharma M&A. Such takeovers, I reckon, may be termed as avant-garde type or disruptive M&As – for holistic value creation for patients.

‘Disruptive M&A’ creates a much broader range of possibilities and targets:

For a holistic value creation through disruptive M&A focus for target selection needs to be significantly different from the standard models of M&As – and not just about the quality of NCE and NME pipeline. The above paper also highlighted: ‘Disruptive M&A opportunities requires evaluating and assessing a much broader range of possibilities and targets than traditional M&A.’

With the right kind of target selection after a thorough analysis of the business model, disruptive M&A may help the acquiring drug companies to go beyond achieving revenue and cost synergies. It can also provide cutting-edge business capabilities, alongside enriching and expanding the talent pool, key business processes, and, of course, the state-of-the-art technology –inorganically.

Initiatives and focus of drug companies of this genre, are expected to be more in the coming years, primarily driven by a new type of value creation to offer a unique disease treatment experience for patients with their respective brands.

A new type of value creation for patients in healthcare space:

It has already started happening in the recent years. For example, Amazon, on January 30, 2018 , announced, it is collaborating with Warren Buffet’s Berkshire Hathaway, and the bank JP Morgan Chase to create an independent, nonprofit health care company ‘with the goal of increasing user satisfaction and reducing costs.’ They also announced the organizational focus on two of the following areas, which are interesting and unconventional:

  • Technology solutions that will provide U.S. employees and their families simplified, high-quality and transparent healthcare at a reasonable cost.
  • Draw on their combined capabilities and resources to take a fresh approach.

As the New York Time (NYT) reported: ‘The alliance was a sign of just how frustrated American businesses are with the state of the nation’s health care system and the rapidly spiraling cost of medical treatment.’ The report further added: ‘It also caused further turmoil in an industry reeling from attempts by new players to attack a notoriously inefficient, intractable web of doctors, hospitals, insurers and pharmaceutical companies.’

Although, this has happened in the United States, it sends a strong signal to the state of things to come sooner than expected in the health care space, dominated, so far, by pure pharma and biotech players, across the world.  New types of value creation for patients of similar nature, especially by tech greenhorns in the pharma space, can be wished away at one’s own peril.

Consumer-focused digital companies redefining healthcare value creation:

‘2019 EY M&A Firepower’ report also highlights the innovative efforts of consumer-focused, digital companies to carve out a solid niche for themselves in the pharma dominated health care space. With ‘effective deployment of their ‘connected devices, data analytics skills and deep consumer relationships, these new entrants are positioned to have access to important real-world data that could, in part or in full, determine future product utilization and payment,’ as the report emphasized.

Such fast-evolving development also prompt pharma players to act fast. And the most practical way of doing so, with a high possibility of success, is through disruptive M&A. Ongoing entry of consumer-focused, digital companies in health care increase the urgency for life sciences companies to act, now.

Conclusion:

Thus far, pharma and biotech companies have been engaged in a massive wealth creation for themselves by using their biological and chemical know-how for novel drugs and devices. This ballgame has to change now, ‘as the lines between health and technology continue to blur’, according to the EY Firepower report.

Capabilities of big data and analytics will increasingly be more essential for success, regardless of having a rich pipeline of NCEs and NMEs, even with the potential to achieve blockbuster status in the market. Thus, the ballgame has to change.

Against this backdrop, the key challenge of pharma players for a brighter tomorrow would undoubtedly be ‘holistic value creation.’ Its core purpose should be to deliver a unique patient experience, encompassing the entire disease treatment process – going beyond innovative drugs. One of the quickest routes to create this virtuous cycle, I reckon, is through ‘disruptive M&As – moving away from the traditional model for the same.

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.

Deadly Climate Change Impact On Human Health: How Prepared Is India?

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It’s not uncommon to find many people, including heads of countries, expressing their serious apprehensions in public, about the scary impact of climate change. Just the last year, on November 26, 2018, BBC News captured one of such incidences with the astonishing headline: “Trump on climate change report: I don’t believe it.” The findings of this report have underscored, ‘unchecked global warming would wreak havoc on the US economy.’

Similarly, a few years ago, on September 05, 2014,CNN News 18 quoted Prime Minister Narendra Modi as saying: “Climate has not changed. We have changed. Our habits have changed,’ while answering to a question on climate change. Regardless of the outcome of any split-hair analysis of the rationale behind such statements from the world leaders, such public discourse could trivialize the possible catastrophic impact of climate change on the planet earth.

Be that as it may, that climate change is taking place, carrying all its ill-effects, is real now, without any ambiguity. There is also widespread consensus among the members of the United Nations that ‘the Earth is warming at a rate unprecedented during post hunter-gatherer human existence.’

It is worth noting that way back in 2001, the ‘Third Assessment Report of the Intergovernmental Panel on Climate Change’, further recorded: “There is new and stronger evidence that most of the warming observed over the last 50 years is likely to be attributable to human activities”, most importantly the release of greenhouse gases from fossil fuels.

Several ‘International Agreements’, including the Paris Agreement on Climate Change - all supported by hard scientific data, have called for immediate, quantifiable measures in each country to address the ‘wide-ranging environmental threats, such as ozone depletion and long-range transboundary air pollution.’ Against this backdrop, in this article, I shall focus on the dreadful effect of climate change in the proliferation of a wide-variety of ailments, especially infectious diseases, within a few decades. While doing so, let me first have a quick recap on what is ‘Climate Change’, in a simple language.

Climate Change – a quick recap:

According to the United Nations, ‘Climate Change is the defining issue of our time and we are at a defining moment. From shifting weather patterns that threaten food production, to rising sea levels that increase the risk of catastrophic flooding, the impacts of climate change are global in scope and unprecedented in scale. Without drastic action today, adapting to these impacts in the future will be more difficult and costly.’

It’s important to note, although, the planet Earth’s climate is constantly changing over geological time, the current period of warming is occurring more rapidly than many past events. Scientists are concerned that the natural fluctuation or variance, is being overtaken by a rapid human-induced warming, as they emit more greenhouse gases. As these gases get trapped in the atmosphere, more heat is retained that has serious implications for the stability of the planet’s climate, even impacting human health with grave consequences. The World Health Organization (W.H.O) has also warned that the health of millions could be threatened by increases in malaria, waterborne disease and malnutrition.

Its impact human health:

The direct and indirect impact of climate change on human health is profound. Before I go into the specifics, let me indicate some of the direct ones, as captured by the Center for Health and the Global Environment (CHanGE), University of Washington. This is sans any charts and maps, unlike the usual practice:

  • Increasing temperatures are causing poor air quality that can affect the heart and worsen cardiovascular disease.
  • Increasing exposure to pollen, molds, and air pollution, all of which can worsen allergies and other lung diseases, such as asthma.
  • Changes in the geographic range of disease-carrying insects, such as mosquitoes, ticks, fleas and other similar ones, which can fast spread many tropical ailments, such as dengue fever and malaria to humans.
  • Increasing frequency and severity of extreme weather and climate events can cause, besides many physical illnesses, several kinds of mental illnesses – increasing both morbidity and mortality.
  • Frequent flooding events and sea level rise can contaminate water with harmful pathogens and chemicals, potentially causing food-borne and waterborne illnesses.
  • Changing weather patterns affect the quality and quantity of nutritious foods with increasing incidence of under-nutrition and micronutrient deficiencies.
  • Additional stress placed on hospital and public health systems, could limit people’s ability to obtain adequate health care during extreme weather events and disease outbreaks.

Most specific and the deadly one:

The World Health Organization (W.H.O) publication - ‘Climate change and human health – Risks and Responses,’ clearly flagged that ‘Changes in infectious disease transmission patterns are a likely major consequence of climate change.’

Citing a pertinent analogy to explain the reason, it said: “Humans have known that climatic conditions affect epidemic diseases from long before the role of infectious agents was discovered, late in the nineteenth century. Roman aristocrats retreated to hill resorts each summer to avoid malaria. South Asians learnt early that, in high summer, strongly curried foods were less likely to cause diarrhea.”

Would pharma players convert these problems into opportunities?

Curiously, some pharmaceutical investors are researching to fathom potential business opportunities lying underneath the above problem, especially for vaccines and newer antimicrobials. It’s probably a blessing in disguise not just for the drug companies, but also for the general public, considering the following two issues, prevailing in the current scenario:

  • According to W.H.O, Antimicrobial Resistance (AMR) is an increasingly serious threat to global public health. It threatens the effective prevention and treatment of an ever-increasing range of infections caused by bacteria, parasites, viruses and fungi, causing the success of even major surgery and cancer chemotherapy seriously compromised.
  • ‘Pharmaceutical companies are backing away from a growing threat that could kill 10 million people a year by 2050’, reported a July 19, 2018 article. This is because, ‘Antibiotics Aren’t Profitable Enough for Big Pharma to Make More,’ wrote another article, published in Bloomberg Businessweek, on May 3, 2019.

Interestingly, a recent report analyzed and evaluated how this can be done, and which companies will be benefitted most in that process. 

“Climate change to fetch a big business opportunity for pharma”:

As reported on July 25, 2019, Morgan Stanley told investors that climate change will cause an increased prevalence and rapid spread of infectious diseases that may be a boon for some drug companies with big vaccine portfolios. It also highlighted, between 383 million and 725 million more people may be exposed to Zika, dengue and other diseases by 2050, depending on the pace and severity of global warming.

The analysts estimated, especially 7 pharma companies will be critical to fighting infectious diseases brought on by climate change. According to the research note of thebank, ‘the USD 500 billion infectious disease market could see demand for an added USD 125 billion in new vaccines, or as much as USD 200 billion assuming premium pricing for more complex new treatments.’

The top possible gainers:

Identifying the top possible gainers, Morgan Stanley apprised, vaccine development being more difficult and expensive, companies that are already in that business will have an upper hand.

Hence, Sanofi and GlaxoSmithKline are expected at the top, given their existing pipelines and manufacturing capacity. Takeda and Merck both have vaccines in the works for dengue fever, one of the diseases that climate change is likely to exacerbate. Janssen and Pfizer are both active in the vaccines market, but would need to establish new research programs to take on tropical diseases. ‘Moderna’ is also in a good position because it has demonstrated a potential pipeline for drugs combating the Zika virus., as Morgan Stanley further elaborated.

Nevertheless, Morgan Stanley isn’t the only bank looking at investment opportunities from climate change, on July 24, 2019, Goldman Sachs also, reportedly, said it was hiring a sustainable-finance group that is looking into issues related to sustainability. Thus, on the positive side, climate change could fetch a big business opportunity for many pharma players, across the world.

600 million people at risk for climate change in India:

On June 24, 2019, a reputed national business news daily of India reported, “600 million people at risk: Climate change may soon turn critical in India.” Against this threat, the current public health care infrastructure in the country, continues to remain fragile, as stated in India’s National Health Profile, 13th Issue.

It also states, the cost of treatment has been on the rise in India and it has led to inequity in access to health care services. Intriguingly, the country spends around 1.02 percent of its GDP towards public health, which has remained static to declining over a long period of time. Although, health insurance is a growing segment, it hasn’t taken off fully. Several measures are needed to improve and expand insurance coverage.

Further, according to the report by the Center for Disease Dynamics, Economics & Policy (CDDEP) in the US, India is facing shortage of 600,000 doctors and 2 million nurses. This report was widely quoted by the Indian media, on April 14, 2019.

These facts give a perspective on what is India’s level of preparedness to address the critical health issues related to climate change, especially the havoc that the dreaded infectious diseases can cause to so many.

Conclusion:

Astute health policy makers, including a large section of the top political echelon of the country are, apparently, aware of various ill effects of climate change. They also seem to be cognizant that these are likely to accelerate the worsening health problems of the population, including infectious diseases, asthma and other respiratory diseases.

Assuming, new and modern drugs will keep coming to help treat these ailments, do we have a functioning and efficient public health infrastructure to grapple with such issues. What about high out of pocket expenditure towards healthcare for a large section of the population, regardless of Ayushman Bharat?

As the (W.H.O) publication - ‘Climate change and human health – Risks and Responses’ recommended, ‘early planning for health is essential to reduce, hopefully avoid, near future and long-term health impacts of global climate change. The optimal solution, however, is in the hands of governments, society and every individual—a commitment to a change in values, to enable a full transition to sustainable development.’

That said, as India is also a signatory to the latest Paris Agreement on Climate Change, can we assume, India will walk the talk to significantly contain its deadly impact on human health? How is India preparing itself to meet this great challenge of Probably it is anybody’s guess, at least, as on date?

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.

Self-made Barriers To Business Transparency Impacting Drug Access

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A recently published book on pharma industry tried to expose the deceit behind many generic-drug manufacturing—and the consequent risks to global health. This publication is described as an ‘explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale.’ However, I reckon, this is just a part of the story, and its huge adverse impact on public health flows generally from the following facts:

  • Greater use of generic drugs is hailed as one of the most important public-health developments of the twenty-first century.
  • Today, almost 90 percent of global pharma market, in volume terms, is comprised of generics.
  • These are mostly manufactured in China and India.
  • The drug regulators continuously assure patients and doctors that generic drugs are identical to their brand-name counterparts, just less expensive.

No question, such deceit, blatant fraud and data manipulation – seriously affecting drug quality of generic medicines, shake the very purpose of making affordable drugs accessible to many. But, simultaneously, lack of transparency – right across the various functions of a pharma business, is also making a host of modern life-saving drugs unaffordable and inaccessible to even more patients. Although, both are despicable acts, but the latter one is not discussed as much.

Thus, in this article, I shall dwell on the second one – how attempts for pharma business ‘transparency’ for expanded drug access to patients, getting repeatedly foiled, especially in light of what happened on May 28, 2019, in the 72nd World Health Assembly (WHA).

Does pharma want low business transparency to continue?

Despite so many encouraging initiatives being taken in the pharma industry over a period of time, gross lack of transparency in its business continues, since long, despite this is being a raging issue. The obvious question, therefore, remains: Does pharma want low business transparency to continue? Thus, to give a perspective to this pertinent point, I shall quote two important observations, appeared in ‘MIMS Today’ – the first one on April 17, 2017, and the other came a year before that, on November 20, 2016, as follows:

  • “A market cannot function when purchasers have limited information and, in the case of prescription drugs, pricing is a black box. Prices for drugs are clearly rising at rates that far exceed inflation and the level of any rebates or discounts offered by manufacturers,” experts opined. They further said, to hold the industry accountable, Access to Medicine Foundation (AMF)’ regularly compiles an index to rank the progress made by each large drug maker in the area of business transparency. Curiously, they concluded, ‘the number and quality of evaluations for the effectiveness of these programs are lacking.’
  • “Lack of transparency of drug makers was also identified. Their policy positions, political contributions, marketing activities and memberships in associations and the associated financial support provided and board seats held were all analyzed. And only then, the ‘AMF’ reached a consensus that transparency remains low in all areas. The analysts further added, ‘there is a lack of transparency and rigor in monitoring and evaluating the access-to-medicines initiatives as well as the link between prices and development costs. Thus, ‘greater transparency from manufacturers to disclose R&D costs for drugs and evaluation of the initiatives’ is imperative.

Despite key policy makers’ favoring transparency, it remains elusive:

To illustrate this point, let me draw a recent example from the United States.

Alex M. Azar II, who is currently the Secretary of Health and Human Services of the United States, also served as president of Eli Lilly USA. LLC from 2012 to 2017 supports the need of business transparency in the pharma industry. Last year, he also emphasized:

“Putting patients in charge of this information is a key priority. But if we’re talking about trying to drive not just better outcomes, but lower costs, we also have to do a better job of informing patients about those costs. That is where our emphasis on price transparency comes in.” By naming the key health care product and service providers, Azar added, “So this administration is calling on not just doctors and hospitals, but also drug companies and pharmacies, to become more transparent about pricing and outcomes of their services and products.”

Like Secretary Azar, policy makers in several other countries, including India, are also talking and seemingly in favor of transparency in health care business systems, but it remains elusive, as we shall see below.

Do vested interests create over-powering pressure to maintain status-quo?

The above examples give some idea about the pressure created by vested interested to maintain a status-quo in this important area. Although, business transparency is a must, pharma influence on policy makers is so powerful that even a recent global resolution on the subject, had to dilute its original version in its final avatar, significantly, which I shall now focus on, as yet another vindication on this issue.

The final version of the 2019 WHA resolution made weaker in transparency:

On May 28, 2019, by a News Release in Geneva, the World Health Organization (W.H.O) announced, to help expand access to medicines for all, the72nd World Health Assembly (WHA) adopted a significant resolution on improving the transparency of markets for medicines, vaccines and other health products, globally. I repeat, this was a global effort to expand access. The assembly brought together delegates from 194 Member States of the W.H.O, including India – from 20 to 28 May 2019, in Geneva, Switzerland.

Intriguingly, as several reports highlighted, ‘the final resolution is considerably weaker than the original draft.’ Nevertheless, it still provides, at least, some measures, which have potential to make an impact on market access, globally.

What exactly was the 2019 WHA original resolution?

The original WHA draft resolution, titled ‘Roadmap for access 2019-2023 – Comprehensive support for access to medicines and vaccines’, urged the Member states the following:

  • To enhance public sharing of information on actual prices paid by governments and other buyers for health products,
  • Greater transparency on pharmaceutical patents, clinical trial results and other determinants of pricing along the value chain from laboratory to patient.
  • Requests the WHO secretariat to support efforts towards transparency and monitor the impact of transparency on affordability and availability of health products, including the effect of differential pricing.

Highlighting that access to medicines is the key to advancing the Universal Health Coverage (UHC), the resolution aims to help the Member States:

  • To make more informed decisions when purchasing health products,
  • Negotiate more affordable prices
  • And ultimately expand access to health products for the populations.

Palpable discomfort of large pharma associations:

The May 30, 2019 article of the Pharm Exec Magazine on this resolution, carried a headline with a query: Is it ‘A Watershed on Transparency and International Collaboration in Drug Pricing?’ The paper brought out some important points that may help explain why the 2019 original WHA resolution, could not be adopted as such. Apparent discomfort in this regard of some top industry associations, which were created and fully funded by large global drug companies, was palpable, according to this report.

For example, “the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), warned governments ‘to carefully consider potential risks to patients, particularly in less developed countries, of sharing outcomes of confidential price negotiations across countries.’ The implication is that prices in less-affluent countries could rise if the wealthier nations used international transparency to demand lower prices for their markets.”

Why couldn’t the original resolution on business transparency be adopted?

To instantiate the level of discomfort of vested interests, let me highlight some critical changes made in the 2019 in final WHA resolution at the international level, as I get from the above paper. A few of which are as follows:

In the original draft Changes in the final resolution
1. “Undertake measures to publicly share information on prices and reimbursement cost of medicines, vaccines, cell and gene-based therapies and other health technologies.” Refers to publicly sharing of information only on net prices.
2. “Require the dissemination of results and costs from human subject clinical trials, regardless of outcome or whether the results will support an application for marketing approval.” “Take the necessary steps, as appropriate, to support dissemination of and enhanced availability of and access to aggregated results data and, if already publicly-available or voluntarily-provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval.”
3. “Require the publication of annual reports on sales revenue, prices, units sold, and marketing costs for individual products, as well as details of the costs of each trial used to support a marketing authorization application and information on financial support from public sources used in the development of a drug.” Calls on the member states to “work collaboratively to improve the reporting of information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives.”
4. Wanted the WHO Director-General to “propose a model/concept for the possible creation of a web-based tool for national governments to share information, where appropriate, on medicines prices, revenues, units sold, patent landscapes, R&D costs, the public sector investments and subsidies for R&D, marketing costs, and other related information, on a voluntary basis.” Diluted only to “assessing the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for health products, including investments, incentives, and subsidies.”
5. Proposed the creation of a forum to “develop suitable options for alternative incentive frameworks to patent or regulatory monopolies for new medicines and vaccines” that would both promote universal health coverage and adequately reward innovation. This point doesn’t find any place in the final resolution.

It appears, the final 2019 WHA resolution has been able to remove the key points of discomfort for the drug industry – caused by greater business transparency. It is largely due to the fact that the final pledges ‘consist largely of recommendations for voluntary action rather than the requirements for comprehensive disclosure proposed in the original draft.’

Conclusion:

To arrive at a consensus, especially over promoting transparency in costs incurred towards R&D of drugs and health-related technologies, appeared challenging for the W.H.O Member States, inthe 72nd World Health Assemblythat concluded on May 28, 2019.Overall resolution changed the narrative from a mandatory process to a voluntary initiative. As I said before, it still prescribes several measures, which can help expand access to medicines for all, across the world.

In tandem, it also comes out clearly that barriers to business transparency to ensure better access to drugs for all, across the world, are not easy to uproot, either. Especially, when it comes to fighting against concerted efforts of powerful pharma lobby groups, other vested interests and some looney fringes.

The process of adoption of the May 2019 WHA final resolution of the world’s most relevant public health issues, is just an example.

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.

Pharma ‘Chatbots’: For Better Stakeholder Engagement

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The critical value of meaningful interaction and engagement with individual customers – responding to their specific needs, is fast drawing attention of many businesses, for sustainable performance excellence. The same is happening in the pharma industry, as well. Creative use of this process leveraging modern technological support systems, would also provide a unique scope of cutting-edge brand service differentiation, in well researched areas.

That, it is a very important focus area for the pharma players, is no-brainer. Nonetheless, what really matters most is the novelty in strategizing such interactions and engagements, especially with patients and doctors. I also wrote about it in my article, titled ‘Indian Pharma To Stay Ahead of Technology Curve,’ published in this blog on May 22, 2017. Over two years ago, I clearly indicated there that application of AI via digital tools, called ‘Chatbots’ – the shorter form of ‘Chat Robot’, is one of the ways that pharma may wish to explore this area.

Illustrating this point in that article, I mentioned that on March 05, 2017, a leading bank in India announced the launch of an AI-driven Chatbot named Eva, coined from the words Electronic Virtual Assistant (EVA), to add more value to their services for greater customer satisfaction. ‘According to reports, Eva is India’s first AI driven banking Chatbot that can answer millions of customer queries on its own, across multiple channels, immediately.’

In this article, I shall dwell on this interesting area, with a primary focus on pharma sales and marketing, and assess the progress made in this space, thus far, by several drug companies, including some Indian players. Let me start by recapitulating the basic function and purpose of ‘Chatbots’ in pharma.

Pharma ‘Chatbots’ – the function and purpose:

Simply speaking, pharma ‘Chatbots’ are also AI-powered, fully automated virtual assistants. Its basic function is to mimic one-to-one human conversation on particular areas, as desired by the user. Likewise, its basic purpose is to genuinely help and assist the customers who are in search of right answers to specific disease related questions, in a one-to-one conversational format, having a higher source-credibility.

In that process, ‘Chatbots’ can effectively satisfy the patients and doctors by providing them the required information, immediately. In tandem, pharma companies also reap a rich harvest, by developing not just a trust-based healthy relationship with them, but also in building a robust corporate brand – creating a long-term goodwill that competition would possibly envy.  

Effective customer satisfaction is an area that can’t be ignored:

In the digital age, a new type of general need is all pervasive, with its demand shooting north. This is the need to satisfy a voracious appetite among a large section of the population for all types of information, with effortless and prompt availability of the required details – as and when these come to one’s mind.

When such information need relates to health concern of a person, such as – available treatment options against affordability, or drug price comparisons – factoring in effectiveness, safety concern – exactly the same thing happens. Most individuals won’t have patience even to write an email and wait for an answer, even the wait is just for a short while.

In the current scenario, it will be interesting to fathom, how would a pharma company, generally, interact or engage with such patients, to further business and creating a possible long-time customer? Some companies have started responding to this need – effectively and efficiently, by providing easy access to information through ‘Chatbots’, created on advances AI platforms. But, such players are a few in number.

Can pharma also think of ‘Chatbots’, like ‘Siri’ or ‘Alexa’?

Today, several people are using standalone and branded Chatbot devices in everyday life, such as, Siri (Apple), Alexa (Amazon), Cortana (Microsoft) or Google Now (Android). Interestingly, many industries, including a few companies in pharma, have also started developing their own version of ‘Chatbot dialog application systems.’

Industry specific ‘Chatbots’ are designed to meet with some specific purpose of human communication, including a variety of customer interaction, information acquisition and engagement – by providing a range of customized services to the target group.’ ‘Siri’ or ‘Alexa’ or the likes, on the other hand, are all-purpose general Chatbots, though, for everyday use of individuals. Thus, the question that comes up, in which areas pharma companies can use Chatbots to add value to their interactions and engagements with patients, in general, and also doctors.

Where to use ‘Chatbots’ as a new pharma marketing channel?

Some of the findings on the application of ‘Chatbots’, especially in pharma sales and marketing, featured in the CMI Media publication in December, 2016. It found that drug companies have a unique scope to leverage this new sales and marketing – channel, by developing ‘Chatbots’ in the company represented therapy areas. Following are just a few most simple illustrations of possible types ‘Chatbots’ for interaction and engagement with patients, which can be designed in interesting ways:

  • That can answer all types of patient questions on specific diseases, educate them about the disease and available treatment options with details.
  • That allows patients or physicians to get all relevant information about the prescription drugs that they require to prescribe for patients to start treatment, including potential side effects, adverse events, tolerability, dosing, efficacy and costs, besides others.
  • Once a treatment option is chosen, a third kind of Chatbot can help with patient adherence to treatment, provide reminders when the treatment should be administered, explain how to properly dose and administer the treatment, and other relevant information.

Chatbots could also be useful for doctors and nurses:

As the above paper finds, ‘Chatbots have value for serving healthcare professionals as well, for example:

  • When, physicians and nurses want to understand the pathogenesis, pathophysiology, and/or progression of a specific disease in their patients.
  • Although, such content may also be available on disease state awareness sites, but branded Chatbots would make that content readily available in more of an FAQ format.
  • When health care professionals would like to get data around safety/toxicity, or information about dosing strengths, calculations, and titrations, while using specific brands.

Chatbots can also be effectively utilized by the drug manufacturer to gain deep insights into customer behavior across all touchpoints, to enhance end-to-end customer experience, as I wrote in this blog on July 02, 2018. The data created through this process, can also be put to strategic use to design unique brand offerings.

Need to chart this frontier with caution:

Pharma, being a highly regulated industry in every country of the world, with a varying degree, though, the ‘Chatbot’ development process should strictly conform to all ‘Dos’ and ‘Don’ts’, as prescribed by the regulators of each country. Each and every content of the ‘Chatbot’ should pass through intense, not just regulatory, but also legal and medical scrutiny. Yet another, critical redline that ‘Chatbots’ should never cross is the ‘privacy’ of any individual involved in the process.

Three critical areas to consider for pharma ‘Chatbots’:

Effective pharma ‘Chatbots’ are expected to get ticks on all three of the following critical boxes:

  • Meeting clearly defined unmet needs of patients in search of a health care solution or most suitable disease treatment options.
  • Brand value offerings should match or be very close to the targeted patients’ and doctors’ expectations.
  • Should facilitate achieving company’s business objectives in a quantifiable manner, directly or indirectly, as was planned in advance.

Pharma has made some progress in this area, even in India:

To facilitate more meaningful and deeper engagements with patients, some drug companies, including, in India, are using ‘Chatbots.’ Here, I shall give just three examples to drive home the point – two from outside India and one from India.

October 23, 2018 issue of the pharma letter reported, a study from DRG Digital Manhattan Research found, ‘Novo Nordisk and Sanofi brands rank best for the digital type 2 diabetes patient experience.’ The article wrote, about some pharma players ‘facilitating deeper engagement through the use of automated tools like Chatbots to triage inquiries and get patients the answers they need faster, and through interactive content like quizzes and questionnaires that pull patients in and help them navigate health decisions,’ as follows:

  • Novo Nordisk‘s diabetes website includes an automated Chat feature dubbed “Ask Sophia,” helping patients access disease and condition management information more quickly.
  • Likewise, Merck & Co‘s website for Januvia employs interactive quizzes to educate patients and caregivers.

Similarly, on November 23, 2018, a leading Indian business daily came with a headline, ‘Lupin launches first Chatbot for patients to know about their ailments.’ It further elaborated, the Chatbot named ‘ANYA’, is designed to provide medically verified information for health-related queries. The disease awareness bot aims to answer patient queries related to ailments,’ the report highlighted.

Chatbots – global market outlook:

According to the report, titled ‘Healthcare Chatbots – Global Market Outlook (2017-2026),’the Global Healthcare Chat bots market accounted for USD 97.46 million in 2017 and is expected to reach USD 618.54 million by 2026 growing at a CAGR of 22.8 percent.

The increasing demand for Chatbot ‘virtual health assistance’, is fueled primarily by the following two key growth drivers, the report added:

  • Increasing penetration of high-speed Internet.
  • Rising adoption of smart devices.

Conclusion:

With the steep increase of the usage of the Internet and smart phones, general demand to have greater access to customized information is also showing a sharp ascending trend, over a period of time. A general expectation of individuals is to get such information immediately and in a user-friendly way.

Encouraged by this trend, and after a reasonably thorough information gathering process, mainly from the cyberspace, many patients now want to more actively participate in their treatment decision making process with the doctors. This new development has a great relevance to drug companies, besides other health service providers. They get an opportunity to proactively interact and engage with patients in various innovative ways, responding to individual health needs and requirements, thereby boosting the sales revenue of the corporation.

The unique AI-driven technological platform of pharma ‘Chatbots’, is emerging as cutting-edge tools for more productive stakeholder engagement – so important for achieving business excellence in the digital world. The recent growth trajectory of ‘Chatbots’ in the health care space, vindicates this point.

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.