Tag Archives: Coronavirus

Taming Two Critical Covid Uncertainties For Pharma’s Sustainable Growth

Posted on by
Reply

The reasons behind a great urgency of the Governments, besides high expectations of the general public, to have the ‘ultimate solution’ very soon, against the ongoing pandemic, are understandable. However, various media-hyped narratives on their clinical trials, and timeframe for expected launch – ranging from November this year to anytime in 2021, are making many experts to raise eyebrows on the scientific processes followed for Covid vaccine development.

Exact answers to the ultimate efficacy standard, safety profile and dates of their availability to the entire population, are still not clear – not even to many domain experts. Besides, two other critical and fundamental questions in India, are related to huge financial resources and other wherewithal, such as, countrywide stringent cold-chain logistics network, required to achieve this goal.

While effective, safe and high-quality vaccines, as and when these will come, will be pivotal to contain the alarming spread of Covid-19 – and that too in a wave after wave manner. Alongside, the intense search for effective anti-Covid medicines are also expected to come to fruition. Doctors will then have in their arsenals a number of highly effective alternatives, that can predictably cure individuals, when infected by this lethal virus.

It causes a great concern when someone asks, when will those days of great relief to all come? For, those days may or may not be very soon – could well be for an indefinite period. No one seems to know the answer, yet.

Until then, pharma companies can’t afford to remain in a ‘quick-fix mode’ to address the problems related to Covid related market and consumer mindset changes. Choosing this path could eventually prove to be very costly, especially for the lost time in leveraging some key opportunities. Moving in that direction, would entail rebuilding the organization by creating a new work-culture – a mindset to be all-time ready for any disruptive changes in business. Most importantly, if or as and when it comes, the organization should not get as overwhelmed, as is happening during the current global pandemic.

In this article, I shall deliberate the following two critical and interrelated Covid-19 issues:

  • The uncertainty in achieving what everybody is expecting to get right away – getting a preventive vaccine or a cure for the infected patients.
  • Inordinate delay in getting prompt medical care by many patients for non-Covid related serious ailments, leading to complexity of the disease. How long this situation will continue still remains uncertain.

As things stand today, these uncertainties could continue for an indefinite period, making some of the Covid related changes irreversible. Thus, my aim will be, first to recap where we are today with these niggles. And then, focusing on the crucial need to pave a balanced pathway – uncharted by anyone, for destination success – in the new world order. Let me begin with the first issue first.

The uncertainty in achieving what everybody is expecting:

Although, some Covid vaccines, reportedly, will be ready by early 2021, uncertainties and delays are still anticipated on the way. Some the reasons may include the following:

  • A critical challenge: About 5.6 billion people worldwide would need to be immune in order to end the pandemic (NEJM). Thus, vaccination process may take years to achieve the coverage necessary for everyone to be protected.
  • Huge investment required: India would need to invest between Rs 3,000 -5,000 crore to create additional facilities for making a huge number of vaccines, required for the Indian population. Currently no one has the capacity to manufacture it for 1.3 billion Indian populations. Moreover, vaccine alone is not the solution to the COVID-19 problem, according to experts.
  • High vaccine cost in India: As these vaccines come from a very difficult platform its cost is going to be significantly higher than many other vaccines, so there is going to be a requirement to think about how we are going to fund this.
  • Coronavirus mutating, potentially evolving: As reported on September 24, 2020, Covid’s continual mutation may make it increasingly contagious. The study says, it’s possible that when our population-level immunity gets high, this Coronavirus will find ways to get around our immunity.
  • The logistical challenge of a lifetime: Getting billions of doses of COVID-19 vaccines around the world quickly, would require 15,000 flights and 15 million cooling boxes. Stringent temperature control requirements for the vaccine supply chain must not be compromised at any point, not even in rural India. It’s worth noting, some of these vaccines may need to be kept at temperatures as low as -80 degrees Celsius. Currently, even in the developed world, the most efficient medical supply chain conventionally distributes vaccines at +2–8°C.
  • Vaccines may not provide complete protection: If COVID-19 re-infections are common, “vaccines might not completely protect against the virus” and would instead require a design similar to seasonal flu shots to protect from new variants. Interestingly. India may, reportedly, approve covid-19 vaccines that show 50 percent efficacy in clinical trials.

Converting problems into opportunities:

Such uncertainties may not only aggravate people’s overall health risks, but also their exposure to Covid infection. Drug companies, drug authorities and various Governments have been working hard on these issues. However, as flagged earlier, amid this health crisis, there is also another growing concern of a very serious nature. It pertains to many people delaying their non-Covid related medical care and medical interventions, for various reasons.

Pharmaceutical companies can convert this problem into a golden business opportunity with ‘patient-centric’ innovative strategies having a cutting-edge, and from a number of platforms. Let me illustrate this point with an interesting example of an initiative taken by a global pharma major, in this area.

A pace setting initiative:

On September 22, 2020, Fierce Pharma reported, ‘J&J wants everyone to know that taking care of their health can’t wait—even during a pandemic.’ This effort is based on the findings of a recent Harris Poll commissioned by them. This study revealed, the COVID-19 pandemic has caused many Americans (68 percent) to delay healthcare treatment. It ranges from standard routine exams to important elective surgeries to ER visits – with physicians sharing concerns about the long-term impact of patients delaying care. The situation is expected to be no different in other countries of the world, including India.

Based on this finding Johnson & Johnson (J&J) have recently launched a US-based online initiative, aimed at giving both patients and physicians information and resources about health care options. This unique campaign has been named – “My Health Can’t Wait”.

By a statement J&J announced: “As the largest healthcare company in the world, we are committed to helping people live their healthiest lives, which means getting the care they need, when they need it.” It added: “Through My Health Can’t Wait, we hope to provide patients and healthcare providers with resources to help stay connected and prioritize their health care, both during this pandemic and in the future.” The point, especially take note of is, ‘both during this pandemic and in the future.’ This part of the above sentence of J&J, echoes the well-known management dictum – converting problem into opportunities, I add, even during the Covid pandemic.

I hope, many pharma players may also wish to pursue similar direction, responding to their own specific needs. But, not just to keep the head above water, in combating this unprecedented health crisis, but with a long-term strategic perspective – to rebuild the organization – for business excellence the new normal.

The concept reverberates:

I find the concept of ‘rebuilding the organization now, for business excellence the new normal’, reverberating in several expert voices. For example, The McKinsey ‘Briefing Note’ of September 16, 2020 – ‘COVID-19 and the great reset.’ It said: ‘The world anxiously awaits an effective COVID-19 vaccine that can be readily distributed. Until then, the priority is to re-energize organizations—to act rather than react. Even as the uncertainties of the COVID-19 crisis multiply, the goal must be to rebuild for the longer term.’

The authors emphasized, ‘a crisis has a way of bringing things to a head.’ Many believe, the coming months might be the best opportunity in memory for healthcare companies to pursue exponential innovation. This, according to McKinsey, ‘could create an additional $400 billion in value by 2025. And now is the time to claim the hundreds of billions of dollars that could be saved through productivity gains.’

Thus, I reckon, apart from creating a great business compulsion of working harder to neutralize the short-term operational constraints, Covid pandemic also provides a unique opportunity to pharma leadership. It gives a space for them for thinking long-term, and from a strategic perspective. The aim is to rebuild the organization, placing it at a higher trajectory for success, in an uncharted frontier, thus far.

Conclusion:

Meanwhile, as on September 27, 2020 morning, India had recorded a staggering figure of 5,992,532 of Coronavirus cases with 94,534 deaths. The virus’s unprecedented onslaught on the country still continues, unabated. Be that as it may, coming back to where I started from, I reckon, pharma companies, in general, could play a stellar role in converting the dual problems of uncertainties into a number of opportunities. In that process, they can create a win-win situation for all, in the health care space.

The uncertainties related to scientifically proven, safe and effective Covid drugs and vaccines will, hopefully, be addressed – sometime, by the scientists and medical researchers. However, as the above McKinsey paper wrote: ‘Until then, the priority is to re-energize organizations – to act rather than react. Even as the uncertainties of the COVID-19 crisis multiply, the goal must be to rebuild for the longer term.’ Thus, the second issue, needs to be creatively leveraged mostly by individual drug players, starting from now.

From this perspective, pharma leadership, will need to commit quality time of thinking people, supported by adequate resources, for conceiving and effectively implementing a ‘patient-centric’ strategy, that patients will fall for in the new normal. That being done, the top honchos, will require to roll up their sleeves to prioritize primary, secondary and tertiary action areas.

Instead of trying to do a little bit of everything, in all possible areas of Covid related changes in the market dynamics, ‘primary action areas’ ought to be the starting point, deploying all resources. And then, expand to the ‘secondary’ and ‘tertiary’ ones, in a well-calibrated manner. Evaluation of results and tightening the strategic loose knots, if any, should be an ongoing process. If implementation of the process requires handholding, so be it. Because, taming these two critical Covid related uncertainties, is intimately related to a sustainable growth for the pharma companies.

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.

 

Aptness Of Pharma Marketing Audit In Covid Days And Beyond

Posted on by
Reply

That, Covid-19 pandemic has changed the operational dynamics of many areas of the pharma industry, as compared to the old normal, is being felt by many. These changes generally fall into two categories. Some are broad industry specific changes, giving rise to a new normal. Whereas, a lot more could often be specific changes required by individual companies in the changing times – depending on how these companies were operating in pre-Covid days. The good news is, the industry specific ones are being well deliberated by many domain experts, almost on an ongoing basis.

Most experts are suggesting digital solutions, for a number of problem areas in the pharma industry as a whole. But, the reality is, for rapid adaptation of the new normal, there is also a crucial need to dovetail the Company specific solutions, with the industry specific generic ones. This effort will call for effective use of robust, well-structured and time-tested systems. However, not as many discussions seem to be taking place in this area, as on date.

As I see around, one such comprehensive and well proven approach is ‘Marketing Audit’. This can be effectively used to ascertain Company specific changes, required for successful pharma business operation during the Coronavirus triggered paradigm shift. It may not sound as zesty as a ‘digital approach,’ but remains fundamentally important for pharma marketers, nonetheless.

In this article, I shall discuss the relevance and the key importance of a comprehensive pharma Marketing Audit, in this trying time for business. Its key purpose is to give shape to a cutting-edge strategy in today’s unfamiliar order. Let me begin with a brief background of the same, for better understanding of all.

Marketing Audit demonstrated its perennial importance over decades:

To put it in perspective, let me refer to a landmark article by Philip Kotler, titled ‘‘The Marketing Audit Comes of Age.’ It was published by the MIT Sloan Management Review, on January 15, 1989. In his review of the need for Marketing Audit, one can get a sense of perennial importance of Marketing Audit, proven over decades.

In Kotler’s own words: ‘The marketing audit as an idea, dates back to the early 1950s.’ An executive at Booz Allen & Hamilton, conducted marketing audits as early as 1952. Its importance of improving business results, was captured by an excellent set of papers under the title ‘Analyzing and Improving Marketing Performance,’ published by the American Management Association, in 1959.  

Covid-19 Surveys highlight general trends, not any Company specific:

We all are witnessing these days, how the Coronavirus pandemic is changing the pharma consumers. In my June 22, 2020 article in this blog on ‘Enhancing Pharma Brand Experience in The New Normal,’ I highlighted some of the basic changes required in the traditional pharma sales and marketing practices.’ These were the generic changes in the marketplace involving the stakeholders. To illustrate this point better, let me cite some recent examples.

The pandemic has suddenly accelerated certain trends:

The lockdowns have brought to the fore certain shortcomings of the pharma industry, more than ever before. Consequently, its serious fallout compelled almost all players ‘to evaluate and adapt its roles and responsibilities almost overnight.’ This point was captured in the ‘Survey results: Accelerating digital transformation during COVID-19,’ published by Reuters Events– Pharma on September 04, 2020. Some of the survey findings included the following:

  • Although, adoption of digital engagement has accelerated, pharma’s ability to deliver exceptional virtual engagement and content is being put to test.
  • Customer Relationship Management (CRM), Content Management Systems (CMS) and customer engagement platforms were found wanting and not fully exploited.
  • There will be a greater emphasis on the Connected healthcare customer journey.
  • Providing a unique customer experience will emerge as a competitive edge.
  • The industry must re-direct resources accordingly, and re-tool to make the most of them.

Let’s now examine some India specific findings from another survey in this space.

Some India specific survey findings:

To explore the impact of COVID-19 on the Indian pharmaceutical industry, another survey, conducted by C Com Digital of India, came out with some interesting findings, some of which are as follows:

  • The new normal warrants a strategic shift in the business operation, besides engagement with doctors and patients.
  • Increasingly, drug companies are moving into online business operations from mostly offline operations of pre-Covid days.
  • Many companies are considering dedicating about 5 percent to 10 percent of their marketing budget towards creating webinars and online communications.
  • Teleconsultations and online consultations are steadily increasing and around 42 percent patients are getting their prescriptions in this way.
  • Doctor visits dropped by 5 percent only during March-April 2020 period.
  • Companies are expanding in online patient education, and online field staff training through custom made e-Learning modules.

As we find above, the emerging new trends are all generic in nature – not enough to prepare any comprehensive company specific strategy for success in the prevailing situation. This brings us to the question: What exactly is Marketing Audit and its relevance during pandemic days?

Relevance of Marketing Audit during pandemic days and beyond:

Thus, the extent of changes required on all sales and marketing related areas, during the pandemic period and beyond, has to be carefully and productively evaluated by each Company, separately. No wonder, why a comprehensive ‘Marketing Audit,’ is also considered “a marketing mirror” - so appropriately.

Without going into the theoretical details, let me first try to explain this terminology in simple terms. It has clearly been established that a Marketing Audit helps understanding, both internal and external marketing environments of an organization, in a comprehensive way. Mainly because, it involves an in-depth and data analysis of the concerned company’s business domain, not just to accurately diagnose the new areas of problems, but also to work out a contemporary – cutting edge marketing strategy.

Thus, I reckon, this tool should be effectively used by pharma marketers, as a high potential mechanism in the marketing warfare, especially during the global pandemic and beyond. Still, some can raise the question, what exactly pharma industry surveys will tell you and what those won’t, – and what gaps company specific surveys will help bridge.

The gaps that Marketing Audit will help bridge:

Industry specific surveys on Covid-19 pandemic would tell the Companies where they should aim to reach. However, each Company would still need to figure out where they currently are in those areas, and most importantly how to reach the target point. An effective Marketing Audit will help the Companies get exact information on where they currently are, and how to reach where they want to reach.

As the new normal is changing, it needs to be done periodically: 

The information obtained through a robust Marketing Audit will help address both customer and market needs – on the one hand and honing or reorganizing the company’s internal value delivery systems commensurately, on the other. However, when an unprecedented or a disruptive change, such as the Covid-19 pandemic keeps striking all conceivable entities, very hard, ‘the new normal’ keeps changing. In this situation, most of the past success ingredients will no longer yield results. Thus, to realign the business with changing market demand, pre-Covid strategic blueprint needs to be redrawn, alongside the necessary wherewithal required for the same.

Marketing Audit, therefore, becomes a periodic requirement for all organizations, assuming the importance of a key business success imperative, if not for survival in the new normal. Any delay in this area may lead to significant loss of Company business.

Conclusion:

According to Covid-19 update of Evaluate Pharma, ‘seemingly uncontrollable advance of Covid-19 in India,’ is perturbing. As on September 20 morning, the country had recorded a staggering figure of 5,400,619 of Coronavirus cases with 86,774 deaths, overtaking Brazil the week before.

The above report points out the potential danger of ‘the country’s health care system to buckle under the weight of hospital admissions for the virus.’ However disturbing this trend may be, from the pharma industry perspective, it sends, at least, four clear signals:

  • It’s a long-haul struggle for the business, as Covid-19 is not going to vanish any time soon.
  • The barriers to in-person interaction will continue for an indefinite period.
  • The market dynamics will keep changing, mostly based on Government’s new guidelines.
  • A robust, flexible, contemporary and comprehensive marketing strategy needs to be supported by stronger and time-tested marketing systems for all times.

From the above perspective, one such time-tested mechanism still remains – ‘the Marketing Audit.’ For business excellence during Covid times, it carries a game changing potential, by dovetailing the industry specific generic problems with company specific strategic solutions.

The criticality of ‘Marketing Audit’ does not remain limited just to bright pharma marketers. It also provides an equally critical top management decision support tool, especially for risk-benefit analysis of the corporate business. Thus, relevance and importance of ‘Marketing Audit’, would remain undiluted, not just during the Covid pandemic – but much beyond.

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.

Neutralize Covid-19 Impact on Drug Prices And Market Access For Faster Recovery

Posted on by
Reply

Covid-19 pandemic that has not spared any facet of human lives and livelihoods, has also reignited several ongoing debates related to the drug industry. The need to urgently resolve these issues grows manifold, as the real magnitude of this health crisis doesn’t seem to be clear even to the key Government decision makers.

This is vindicated by the research paper, written by government scientists and other experts, published on September 10, 2020 in the Indian Journal of Medical Research. It reveals, India had nearly 6.5 million cases as early as May 2020. Whereas, according to the health ministry, the total number cases stood at around 180,000 in late May. This happened because, ‘large numbers of cases could have gone under the radar earlier this year, because testing was limited to symptomatic patients or states had varying testing rates,’ the paper highlighted.

From the pharma industry perspective, a pandemic of such magnitude is also causing indefinite delay in pre-planned market access of several important drugs and vaccines. Some are due to technical reasons. However, many others are related to their value-based cost-effectiveness in the new normal, when the pandemic has put enormous strain on health expenditure, across the world.

In this situation, past mechanisms of new drug pricing, are required to undergo significant changes. The new yardsticks, I reckon, will be based on two critical factors. The first – the disease treatment priorities, as will be decided jointly by both doctors and patients. And the second – the paying capacity of both payers and individual patients, based on the value that each treatment will offer – again, as perceived by patients.

As it appears, the impact of Covid-19 on the pharma industry will continue till the medium term, if not beyond. Consequently, the concept of new drug pricing – based on well-documented, differential value offerings of treatments, would need to be revisited and recalibrated. This has to be realigned with evolving patient needs. Considering the emerging scenario, this article will focus on the exigency to neutralize Covid-19 impact on new drug prices and pre-planned ‘market access’ – for faster business recovery.

Covid-19 has increased the drug price sensitivity:

The challenge of increasing drug price sensitivity – triggered by the new Coronavirus pandemic, has now assumed a global dimension. A June 18, 2020 study, flags: ‘Nine in 10 Concerned About Rising Drug Costs Due to COVID-19.’ Although, this particular study (Gallup Poll) was conducted in the United States, general public apprehension is no different in other parts of the world, including India, for various reasons.

Even in America, which is considered Eldorado for pharma business, primarily for unregulated drug pricing, is also changing with the impact of Covid-19. The reason being, reported instances of drug prices are rapidly rising, amid the pandemic. As the above Gallup Poll highlights, today ‘a large majority of Americans support direct negotiations by the federal government with the drug manufacturer on the price of a treatment for the disease itself.” Interestingly, ‘significant support exists across all major demographic groups.’

Other specialists on pharmaceutical pricing and market access, also envisage that pharmaceutical companies will be faced with increased price sensitivity, and are quite concerned with the long-term impact of the pandemic on health care systems.

Covid-19 pandemic would seriously impact pharma spending:

As quoted above, several other specialists for pharmaceutical pricing and market access have also pointed out some critical Covid-19 impact areas, including:

  • Tremendous increase in pandemic related public expenditure, could prompt further austerity measures in already strained health care budgets, besides job losses or pay cuts of scores of people for different reasons.
  • The pandemic is likely to result in a redistribution of health care funding towards infectious diseases (e.g. prioritization of antivirals and vaccines) and chronic diseases associated with worsening COVID-19 outcomes.
  • This may result in more drug pricing pressure in other disease areas, besides push for increasing use of similar cheaper generics and biosimilars, unless absolutely necessary.
  • Stricter monitoring of usage of medicines, especially in private hospitals, to ensure their use within the regulatory label and/or within the reimbursed population.
  • Possibility of mandatory price cuts either across the board or for drugs which have been on the market for a specific duration.

The report also envisages, pharmaceutical companies will be faced with increased price sensitivity and decrease in willingness to pay by authorities. Consequently, the key question in this area becomes: What impact will COVID-19 have on the future of pricing and market access? And how to address this issue, effectively? 

Need for an appropriate drug pricing models in the new normal:

Overall scenario for drug pricing model has not changed much, till Convid-19 pandemic overwhelmed the world. The age-old concept of drug pricing, being treated as almost given, is changing fast. As I wrote earlier, it started in the developed world, with newer concepts, such as, Health Technology Assessment (HTA), besides a few others. However, to illustrate the point, I shall focus only on the HTA model. It includes a multi-faceted assessment of the clinical, economic, ethical, legal, and societal perspectives that may be impacted by a new technology, procedure, drug, or process.

Application of HTA in Medicine Pricing:

The ‘Working Paper 6’ of June 2013, on ‘The Role of Health Technology Assessment in Medicine Pricing and Reimbursement,’ published jointly by the World Health Organization (WHO) and the Health Action International (HAI), is worth referring to.

The paper aims to identify and describe the role of HTA in price-setting and reimbursement of pharmaceuticals, with a focus on its use in low and middle-income countries (LMICs). However, as Covid-19 is now fueling the drug price sensitivity across the globe, and not just in the LMIC, this reference will help drive home the point, as one faces today.

While combating health care resource crunch in the face of the Coronavirus quagmire, many countries are contemplating a variety of approaches to maintain affordable access to healthcare for patients. The concept of HTA is one such common approach. It includes pharmaceuticals, vaccines, medical devices, medical and surgical procedures, besides the systems within which health is protected and maintained.

Relevance of a recalibrated HTA in the new normal:

For a new drug, as the Institute For Clinical And Economic Review (ICER) puts it, a final HTA report would attempt to answer the following questions, besides a few others:

  • Is it safe and effective?
  • Which patients benefit the most?
  • Is there a meaningful improvement in health status?
  • Can all people afford to pay who might need it?
  • Will it offer a good value in the long run?
  • What other considerations make it important?

These points need to be looked at keeping in view that Covid-19 pandemic has seriously impacted the health care spending. Thus, the process needs to be recalibrated in the new normal. In any case, HTA has the potential to play a critical role in new drug pricing, by assessing the intrinsic value of medicines that can significantly expand patient-access to care. In tandem, it could maximize the value for money in health expenditure with most efficient allocation of scarce health resources, that most countries are facing today. Nevertheless, there could well be a few company or country specific barriers to capture the value of a drug or treatment, as well. A robust plan for their mitigation needs to be well-thought through, to ensure effective implementation and achieve desirable outcomes.

HTA in India:

At least, on paper HTA exists even in India. The Government of India had created an institutional arrangement called “Health Technology Assessment in India (HTAIn)”, under the Department of Health Research (DHR). It was entrusted with collation and the generation of evidences on cost effectiveness and safety of health care interventions, including medicines and devices.

The key goals are, to reduce the cost of patient care, overall cost of medical treatment, reduction in out of pocket expenditure of patients, besides streamlining the medical reimbursement procedures. Nevertheless, it remains a million dollar question whether India would leverage this system to ensure fair pricing of new drugs in India.

Some pre-requisites to implement HTA – afresh:

In those countries, where HTA for drug pricing and reimbursement doesn’t already exist, there could be several pre-requisites. These may include, as the above paper indicates, establishing a medicines regulatory system, developing and enforcing legislation, employing the appropriate technical expertise, and the allocation of sector-wide financial resources in accordance with the decisions of the organization using the HTA.

That said, the bottom-line is, the quest to arrive at fair pricing for a new drug, could also help ‘market access’, especially in a difficult time, like today’s health care crisis. In that endeavor, let me briefly dwell on the concept of ‘fair pricing a drug’.    

The concept of ‘fair pricing a drug’:

This issue has been well deliberated by many experts around the world. However, let me quote a recent article – ‘Defining the concept of fair pricing for medicines,’ published by The BMJ on January 13, 2020.

The paper articulates, ‘a fair price for a medicine is affordable to the buyer while covering the seller’s costs and providing a reasonable profit margin. Within a fair pricing zone, a specific price may be higher or lower, possibly reflecting differential value.

Interestingly, the authors also noted: ‘Applying the framework to decision making would require access to data on R&D, manufacturing, and distribution costs, which is generally not publicly disclosed. This lack of transparency about costs undermines efforts to assess the fairness of medicines prices.’

The article underscored, lack of transparency in these areas, ‘also exacerbates information asymmetry to the sellers’ advantage.’ It suggested, disclosure can be enforced through legislation, regulation, and judicial action. Or as a condition of receiving public research funds, tax benefits, regulatory approval. Or listing in a formulary for reimbursement. ‘In the absence of disclosure, decision makers may rely on reasonable estimates based on publicly available information,’ the paper concluded.

Conclusion:

As recorded in the morning of September 13, 2020, total Coronavirus cases in India have reached a staggering figure of 4,754,356 with 78,614 deaths, overtaking Brazil. This trend continues going North, as days pass by.

All-pervasive Covid-19 pandemic is fueling severe resource constraints, especially for health care. Amid this complexity, to combat this deadly virus – alongside other non-Covid related illnesses – value added drugs and treatments could help overcome many hurdles in this area. They could help improve cost-effectiveness of treatments to price-sensitive patients, besides other stakeholders.

Recalibrated HTA mechanism, which I have used in this article as an example to effectively overcome prevailing drug price sensitivity, is one among a few others. Importantly, HTA mechanism exists even in India. It can be appropriately used for new drugs and vaccines pricing, if the Government wishes to.

On the other hand, it’s up to individual companies to choose any other price-value model’ that they will deem appropriate, to arrive at a ‘fair value for new drugs’. However, the goal remains common for all - Neutralizing Covid-19 impact on drug prices and market access, to ensure faster recovery of the business.

By: Tapan J. Ray   

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

Covid-19 Pushes Pharma To Walk The Talk of ‘Patient-Centricity’

Posted on by
Reply

Echoing many other industries, such as, Fast-Moving Consumer Goods (FMCG), pharmaceutical industry leaders, as well, have been talking about putting their customer at the center stage of strategic decision-making processes. In other businesses this grand intent is generally expressed as, ‘customer oriented’ or ‘customer-focused’, or ‘customer-driven’, besides several other similar expressions.

However, in the pharma industry this popular expression is widely talked about as ‘patient-centricity.’ Nonetheless, it is also generally believed that pharma leaders, weren’t hugely inclined to ‘walk this talk’ – until Covid-19 pandemic struck the world – very hard. In this article, I shall delve into this area, focusing on several aspects of it. Let me begin with, what COVID-19 has taught about pharma’s ‘patient-centricity’ efforts.

What COVID-19 has taught about pharma’s patient-centricity efforts:

A recent study, titled, ‘What COVID-19 has taught us about pharma’s patient centricity efforts,’ published by ZS on July 05, 2020, unravels some interesting findings in this area. Some of those points are as follows:

  • ZS’ mid-2019 ‘Patient Centricity Industry Study’ had found nearly universal agreement about the importance and significance of being patient-centric.
  • But the investment for the same did not match the intent, creating an “optimism gap” where senior leaders think more progress than middle the management.
  • At that time, while 73 percent of participants agreed that ‘patient centricity’ is fundamental to their organization, only 16 percent said they understood their individual role in the organization’s ‘patient centricity’ initiatives.
  • Whereas, during the past few months as the industry responds to Covid-19 pandemic, ‘pharma has demonstrated that it can quickly mobilize to surround and support patients, making the workforce focus on the patient priorities.
  • Over the past three months, organizations were found to look at new ways to engage with patients. For example, patient panels to continually check in and monitor the impact on the patient experience, connecting with patient advocacy groups – to get a pulse on critical needs and leveraging the field force to hear from physicians where their patients need the most help.
  • These companies are also investing now to understand the impact of Coronavirus on the patient and partner with others in the ecosystem.

Some interesting industry initiatives during Covid-19 pandemic:

This  ZS study noted, several pharma companies are showing great flexibility and creativity in tapping into their combined expertise and skills to support patients and the healthcare community, in a time of need. Some of the interesting examples cited in the paper include:

  • Pfizer rolled out a five-point plan, including an R&D SWAT team to support vaccine development.
  • Lilly, Merck and others banded together to help employees with relevant skills, volunteer on the front lines of treatment
  • Several other pharma companies have also joined with the Bill and Melinda Gates Foundation to share data.

I hasten to add, according to this study, some industry leaders did agree that COVID-19 has proven that it’s possible to actually be more patient centric in business operations for better outcomes. However, many pharma players would still need to ‘walk this talk’ and put in hard work with adequate resources in getting there – the study noted.

Could ‘patient-centric pathway lead to post Covid-19 business recovery?

Just lip service on ‘patient-centricity’, as witnessed earlier, is unlikely cut any ice in the new normal, as people start living with the new Coronavirus, in everyday life. Making this more touted, but less practiced concept work on ground in pharma, is expected to be one of the effective pathways for early business recovery, as we move on.

The McKinsey article of May 12, 2020, titled ‘Pharma operations: The path to recovery and the next normal’ has also flagged this issue, alongside a few more. Similar to the findings of the above ZS study, this paper also noted that ‘leaders of operations in the pharmaceutical industry have been historically slow to respond to changing times. Interestingly, during COVID-19 pandemic, many of those leaders were found highly responsive to the new demand of time. They ‘rallied to enable the supply of key medicines across borders, manage workforce safety, and handle evolving government restrictions, while beginning to prepare for new vaccines and therapeutics, it noted.

More importantly, several companies have now put in place crisis-response command centers. These hubs play critical roles to appropriately manage and bring stability in an otherwise unstable time. From this experience, in my view, ‘patient-centricity’ could be an effective pathway to follow for post Covid-19 business recovery. Having said that, let me try to tighten some loose knots of understanding in this specific area, as below. To start with, let us together recapitulate a brief background of evolution of ‘patient-centricity’ concept in the drug industry.

“No decision about me, without me”:

Not so long ago, the National Health Service (NHS) of U.K realized that every patient should be as actively involved in making decisions about their health and health care as they wish to be. Accordingly, in 2012 it released the White Paper - ‘Equity and Excellence: Liberating the NHS,’ setting out the U.K Government’s vision of an NHS that puts patients and the public first, where “no decision about me, without me” is the norm.

The concept of ‘patient centricity’ in the pharma industry is believed to have grown from the above concept. The core idea of the concept, as defined in a BMJ article is, “Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family”.

The authors envisage, effective implementation of the same would provide an opportunity for drug companies to adopt and use its core facets as reference points for patient engagement, throughout a product life cycle. In tandem, this also flags an important point: Why the concept of ‘patient-centricity’ is mostly talked so ‘passionately’ by almost all drug companies, while very few of them seem keen to ‘walk the talk?’

The key barriers to achieving ‘patient-centricity’:

The key puzzle on ‘Patient centricity: everyone wants it; not everyone gets it’, was well-deliberated by Reuters Events (Pharma), published on December 14, 2024. It pointed out – as an aim ‘patient-centricity’ is all too often overlooked, despite the fact that even several top pharma companies often express their desire to be patient centric organizations; such as:

  • “Inspired by patients, driven by science” (UCB);
  • “Science and patients…the heart of everything we do” (AstraZeneca);
  • “A global integrated healthcare leader focused on patients’ needs” (Sanofi).

Analyzing the overall reasons for the same, the paper articulated: ‘Difficulties in communication with patients, skepticism about their input, and unwillingness to relinquish control are some of the barriers to achieving patient centricity.’ Interestingly, this situation remains generally unchanged even today.

Conclusion:

Meanwhile, as recorded in the morning of September 06, 2020, total Coronavirus cases in India have reached a staggering figure of 4,113,811 with 70,679 deaths, despite every effort taken by the Government. As PTI reported on September 05, 2020: At the current pace, India will overtake Brazil early next week to become the country that has seen the second highest number of cases.’ With this perspective, let us now look at the concept of ‘patient-centricity’ for better treatment outcomes.

As deliberated earlier, just as providing affordable care for all – making ‘patent-centricity’ the centerpiece of the core business strategy for pharma, had remained akin to chasing the ‘Holy Grail’. This happened, despite last so many years one could easily spot inclusion ‘patient-centricity’ even in the corporate vision and mission statements of many drug companies.

As it appears today, the term ‘patient centricity’ remained another cliche, till Covid-19 disrupted the status quo of the old normal? But, will it last long? Only another robust study in the future, I reckon, will be able to confirm it. However, this would mostly depend on whether patients continue sending signals of: “No decision about me, without me,” for better health outcomes.

It’s not a terribly disputed fact, either that various stringent norms in the Covid lockdown period, have prompted many health care consumers switching from their good old health care practices, to the digital or online mode to meet with similar needs. Consequently, they are now becoming more digitally empowered than ever before. In this situation, leveraging AI with expert help, would help implement ‘patient-centricity’ more productively to meet challenges of the new normal.

If done with precision, it would help move even beyond ‘patient-centricity’ in the new normal, with better disease prevention or management and ‘connected healthcare,’ leading to better quality of lives for many. Thus, Covid-19 pandemic – pushing pharma to ‘Walk the Talk’ of ‘patient-centricity,’ if lasts long, could usher in a fundamental change in the health care space. It has demonstrated its huge potential during the ongoing pandemic to ensure patient-friendly, high quality, affordable and universal health care value delivery – for patients’ sake.

By: Tapan J. Ray   

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

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

Posted on by
Reply

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

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

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

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

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

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

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

Perils of haste in the Hydroxychloroquine saga:

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

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

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

Soon, India followed the same… a strange coincidence?

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

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

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

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

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

Its rub-off financial impact in India:

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

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

Perils of haste in the plasma therapy saga:

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

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

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

Conclusion:

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

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

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

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

By: Tapan J. Ray  

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

Covid-19 Vaccines – A Multifaceted Perspective

Posted on by
Reply

Even after the destruction of millions of lives, livelihoods, social fabric and national economy of almost all countries – the mayhem of the Coronavirus pandemic continues, unabated.

Echoing what many other global experts, the United States National Institute of Allergy and Infectious Diseases Director has also reiterated ‘that the only “ultimate solution” for the Coronavirus would be a vaccine.’ He added, the social distancing measures and travel restrictions could help curb the outbreak but can’t last forever. Moreover, the virus might come back. Thus, only a vaccine could help in the long run.

That a speedy progress in achieving this goal, is the most critical remits for the global medical scientists and technologists, attract not many contrarian viewpoints. Nevertheless, some red flags are also visible in this critical area. Thus, to give a multifaceted perspective to the ‘Covid-19 vaccine story’, let me dwell on some of these contentious areas.

Vaccines may not be ‘silver bullets’ for all:

According to the news release of the World Health Organization (W.H.O) on July 15, 2020, 75 countries have submitted expressions of interest to protect their populations and those of other nations through joining the COVAX Facility. This is a mechanism designed to guarantee rapid, fair and equitable access to COVID-19 vaccines worldwide. These countries would finance the vaccines from their own public finance budgets and partner with up to 90 lower-income countries.

It further added, interest from governments representing more than 60 percent of the world’s population offers ‘tremendous vote of confidence’ in the effort to ensure truly global access to COVID-19 vaccines, once developed.

Expressing its optimism and also a concern at the same time, the W.H.O on August 03, 2020, informed – out of a number of vaccines, which are now in phase-3 clinical trials, it hopes to have a number of effective vaccines that can help prevent people from infection. Interestingly, in the same breath, it cautioned, “there’s no silver bullet at the moment and there might never be.” The question, that may arise, if a ‘silver bullet’ in the form of Covid-19 vaccines is not available and a vaccine doesn’t work for all, how complicated would then the situation be? Can one expect Covid-19 to end, at all?

When can one expect Covid-19 to end, if at all?

Closely following the above message – “there’s no silver bullet at the moment and there might never be,” another message, a bit intriguing, though, came from the W.H.O on August 22, 2020. This time the W.H.O said, “it hopes the planet will be rid of the Coronavirus pandemic in less than two years — faster than it took for the Spanish flu.” Elaborating the point, the W.H.O Chief underscored, by “utilizing the available tools to the maximum and hoping that we can have additional tools like vaccines, I think we can finish it in a shorter time than the 1918 flu.”

The impact of anti-vaccine movement to end Coronavirus pandemic: 

The question may sound crazy to many people, especially in India, but a similar concern has been expressed by many experts. The article – ‘Anti-vaccine movement could undermine efforts to end Coronavirus pandemic, researchers warn,’ published by the Nature on May 13, 2020, also raised this issue. The researchers of the study at the George Washington University, wrote - ‘studies of social networks show that opposition to vaccines is small but far-reaching — and growing.’

That anti-vaccine sentiments continue growing online, as medical scientists are flooring the gas pedal, has also been reported by ‘India Today’ on May 28, 2020 in an article titled, ‘Experimental Covid shots inject anti-vaccine sentiments.’ This belief was ‘prompted by theories that fast-tracked programs are profit-driven, loaded with health risks and will eventually lead to enforced immunization,’ it underscored. Notably, the W.H.O also has flagged the growing anti-vaccine feeling.

W.H.O flagged the growing anti-vaccine feeling:

The issue of growing anti-vaccine feeling has also been flagged by the W.H.O. It noted several reasons for fear of or opposition to vaccination, such as:

  • Some people have religious or philosophical objections,
  • Some see mandatory vaccination as interference by the government into what they believe should be a personal choice,
  • Others are concerned about the safety or efficacy of vaccines,
  • Or may believe that vaccine-preventable diseases do not pose a serious health risk.

Several of these could be significant in some geographical areas, within activist groups, community leaders, people with a different mindset, which may not be too difficult to overcome. Whereas, a few others may throw huge financial and logistical challenges to the nations. Interestingly, ‘one in three Americans is reluctant to take a COVID-19 vaccine.’

One in three Americans appears reluctant to be vaccinated:

According to a Gallup poll conducted between July 20, 2020 and August 02, 2020 ‘one in three Americans would not get a COVID-19 vaccine.’ This poll brought out the fact that ‘many Americans appear reluctant to be vaccinated, even if a vaccine were FDA-approved and available to them at no cost. Asked if they would get such a COVID-19 vaccine, 65 percent say they would, but 35 percent would not.’ Moreover, the percentage of Americans who feel strongly that parents should get their children vaccinated has also dropped by 10 percentage points, since 2001.

Other recent polls, reportedly, also found, whereas, around 50 percent of people in the United States are committed to receiving a vaccine, another quarter is still wavering. Some of the communities most at risk from the virus are also the “most leery.” ‘In France, 26 percent said they wouldn’t get a Coronavirus vaccine.’

Which is why, Covid-19 vaccines, which are expected to be available by early 2021, ‘won’t be mandated by the federal government’, according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “I don’t think you will ever see mandating of a vaccine, particularly for the general public. If someone refuses the vaccine in the general public you cannot force someone to take it,” he opined.  

But how broad is this ‘spectrum of doubt’?

As captured in the article, “The Coronavirus pandemic is the moment of truth for anti-vaccine movement,” published by the Financial Times on April 28, 2020, some of the emerging issues are worth pondering. It wrote, although, there is a small, highly organized group of people who are implacably against vaccinations, ‘there is a whole spectrum of people who are concerned, or are on the fence, about them.’ According to a poll it conducted in late March 2020, Covid-19 ‘outbreak has the potential to change their minds’ in different ways, such as:

  • Just 5 per cent of people in the UK say they would not take a Covid-19 vaccine if it were available, down from 7 per cent the week before.
  • Whereas, in Austria, 18 per cent said they would not take a Covid-19 jab, compared with 16 per cent three weeks previously.
  • The figure is similar in France, where 33 per cent – the highest proportion in the world — disagree with the statement “vaccines are safe”, according to another 2018 survey by the health research organization – the Wellcome Foundation.

Is there any anti-vaccination movement in India?

This issue has been well deliberated in many papers, one such is the article, “Theme – Ethical And Legal Challenges Of Vaccines And Vaccination, Public trust in vaccination: an analytical framework.” It was published in the Indian Journal of Medical Ethics (IJME), Vol 2, No 2 (NS) (2017). It makes some noteworthy points:

  • While vaccination is one of the most successful public health interventions, there has always been a parallel movement against vaccines.
  • Apart from scientific factors, the uptake of vaccinations is influenced by historical, political, socio-cultural and economic factors.
  • In India, the health system is struggling with logistical weaknesses in taking vaccination to the remotest corners; while on the other hand, some people in places where vaccination is available, resist it.
  • Unwillingness to be vaccinated is a growing problem in the developed world. This trend is gradually emerging in several parts of India as well.
  • Other factors, such as heightened awareness of the profit motives of the vaccine industry, conflicts of interest among policymakers, and social, cultural and religious considerations have eroded many people’s trust in vaccination.

The paper concludes by arguing that engaging with communities and having a dialogue about the vaccination policy is an ethical imperative. Be that as it may, the question still remains: With vaccines can people go back to the old normal?

Despite vaccines ‘We cannot go back to the way things were’:

It is for sure now that despite vaccination, people won’t be able to get back to the old normal. On August 21, 2020, the W.H.O further clarified ‘that a vaccine will be a “vital tool” in the global fight against the Coronavirus, but it won’t end the Covid-19 pandemic on its own and there’s no guarantee scientists will find one.’ One can find a clear meaning to this statement, if the same is read along with the W.H.O Chief’s earlier statement that “there’s no silver bullet at the moment and there might never be.”

Other challenges for mass vaccinations in India:

There are some research studies in this area. Let me quote one of those, published in the International Journal of Pharmaceutical Sciences and Research. The paper noted – although, immunization is the most cost-effective intervention for infectious diseases, there exists a scarcity of information on vaccination status of young adults and the role of socioeconomic conditions in India.

The study concluded – although Td/Tdap (97.3 percent) and MMR (66.4 percent) coverage was in line with the recommendations, for all the other vaccines the coverage was lower – varying from 5.5 percent to 35.4 percent. A number of factors were found responsible for limited growth and penetration of vaccines in India, such as:

  • Lack of adequate awareness among both physicians and patients.
  • Patients prefer treating rather than preventing diseases.
  • Vaccines are provided free under UIP program, but only for highly communicable and life-threatening diseases.
  • Obtaining vaccines through private system is expensive and medical insurance policies do not cover vaccines.
  • A lack of quality data on disease burdens and vaccine efficacy is the biggest obstacle in vaccine coverage in India.
  • Distribution is hampered by inadequate cold chains and constrains to last mile distribution. Storage in the clinics is limited due to frequent electricity blackouts in India.

The vaccination coverage was found better in respondents with higher educated and higher income parents. The researchers suggested patient education, planning by government for the implementation of policy for adult vaccination and involvement of physicians are must for better adult vaccination coverage.

Conclusion:

The United States, Brazil and India now account for more than half the total of over 22 million Coronavirus cases, globally. The number of fatalities had also gone past 782,000, as on August 20, 2020.  However, the Coronavirus cases in the country, as recorded in the morning of August 23, 2020, have also reached a staggering figure of 3,044,940 with 56,846 deaths, despite all measures that the country has been taking. No signs of any respite, just yet.

The Government of India has officially acknowledged that for protection from Covid-19 infection, ‘the herd immunity level is “far away” for the Indian population and it can only be achieved through immunization by vaccines.’ Hence, the country’s dependence and stake on this ‘silver bullet’ are very high. From this angle, the vaccine story needs to be viewed from a multifaceted perspective, including what the W.H.O has already cautioned:

  • ‘There’s no silver bullet at the moment and there might never be.”
  • ‘That a vaccine will be a “vital tool” in the global fight against the Coronavirus, but it won’t end the Covid-19 pandemic on its own and there’s no guarantee scientists will find one.’
  • The Coronavirus vaccines alone won’t end pandemic: ‘We cannot go back to the way things were’ in the old normal. In other words, people should try to adapt to the new normal to lead a normal life.

Besides, there could be other problems like, making vaccination mandatory. Or, distributing affordable Covid-19 vaccines through uninterrupted cold-chains in the remotest part of India, and appropriate storage there. Does India have a robust logistics support for the same, in place? Who will pay for all these? And more importantly, are there Plan B, C & D ready, to meet any unforeseen critical situation. Each of these warrants a deep-stick analysis – with a multifaceted perspective, as the devastating impact of Covid-19 pandemic is so real for all, especially for India.

By: Tapan J. Ray  

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

Covid-19: A Paradox: Impact On Demographic Dividend: Vaccine Rush

Posted on by
Reply

Not so long ago, on September 25, 2019, while delivering the keynote address at the Bloomberg Global Business Forum in New York, Prime Minister Modi talked about the future direction of India’s growth story. He emphasized, this story was built on four pillars, namely Democracy, Demography, Demand and Decisiveness. Today, except perhaps the first pillar – Democracy, all three other pillars have been greatly impacted, especially by Covid-19 pandemic, just round a year’s time. Interestingly, while delivering the 74th Independence Day speech on August 15, 2020, the Prime Minister indicated: ‘Covid-19 is not an obstacle big enough to hamper self-reliant India’s growth’

That said, out of those 3 pillars, ‘demography’ of the country, I reckon, offers a key differential economic advantage to the nation. According to the Prime Minister’s own words: “This growth is facilitated by India’s demographic dividend and young and talented people.” Alarmingly, the collateral damage of the new Coronavirus pandemic has significantly affected this critical growth pillar, as well. Thus, I would cite this ‘pillar’ as an example, to drive home the point – how Covid-19 is impacting the demographic dividend, impeding the economic growth of a country, like India.

At the same time, it is becoming increasingly clear today, the new Coronavirus ‘maze’ is refusing to signal any clear pathway to get back to the ‘old normal,’ while the ‘new normal’ is yet to crystallize.From this perspective, let me deliberate in this article, with examples from the following two important areas:

  • A paradox that is directly related to Covid-19 transmission in various countries.
  • The collateral damage on ‘demographic dividend’.

These illustrations will vindicate that there isn’t any other meaningful option – for an indefinite period, but to wait (or rush) for vaccines, in the prevailing quandary.

The paradox: 

As the world awaits scientifically proven, safe and effective vaccines, duly approved by the drug regulators, to come out of Covid-19’s lethal shackles, several paradoxes further add to the complexity of the problem. Many of these seem to be quite difficult to untangle. One such paradox, for example, the observed case-fatality ratio (CFR). It indicates, the number of deaths either per 100 confirmed Covid-19 cases or per 100,000 population. The latter represents a country’s general population, with both confirmed cases and healthy people.

As analyzed by the Johns Hopkins University - among the twenty countries most affected by COVID-19 worldwide as of August 09, 2020, the United Kingdom (UK) had over 300,000 confirmed cases along with 70.16 deaths per 100,000 of its inhabitants. Peru and Chile had the second and third highest total per 100,000 of the population with 64.55 and 53.45 respectively, while the U.S. followed – with 49.65.

Similarly, while India shows a CFR of 2.0, other countries – quite different, particularly in economic and demographic parameters, are also not doing too badly, some are doing even, better as far as the CFR is concerned. These nations include, Pakistan 2.1, Vietnam 1.8, Thailand 1.7, Myanmar 1.7, Philippines 1.7, Australia 1.6, Malaysia 1.4, Bangladesh 1.3, Sri Lanka 0.4, Maldives 0.4 and Nepal, to name a few.

From these numbers, it appears, the CFR has neither any bearing on the degree of overall economic development of a country, nor how robust is the nation’s health care infrastructure, beside others. In that case, in which areas a country should focus to keep Convid-19 death rate low? A specific answer to this question is awaited. Till then does it not remain a paradox?

Impact on demographic dividend:

Besides the direct impact of rapid transmission of the Coronavirus infection and its associated fall outs, the livelihoods of many and crippling blows on the national economy, Covid-19 pandemic is silently making serious collateral damages. One of these is a significant impact on the demographic dividend, especially for a country like India. As many would know, ‘demographic dividend’ broadly refers to the growth in an economy that is the result of a change in the age structure of a country’s population, where the proportion of the working population out of the total population is high.

This issue has been well-captured in the August 11, 2020 report – ‘Youth & COVID-19: Impacts on jobs, education, rights and mental well-being,’ of the International Labor Organization (ILO). The report captures the immediate effects of the pandemic on the lives of young people (aged 18–29) with regards to employment, education, mental well-being, rights and social activism. Over 12,000 responses were received from young people in 112 countries. A large proportion of these came from educated youths with access to the Internet. Some of the key findings of this survey may indeed be a cause of worry for many, such as:

  • The pandemic is inflicting a heavy toll on young workers, destroying their employment and undermining their career prospects.
  • 38 per cent of young population is uncertain of their future career prospects due to the pandemic. They expect COVID-19 crisis to create more obstacles for them, besides lengthening the transition from school to work.
  • Mental well-being is lowest for young women and younger youths between the ages of 18 and 24 years.
  • One in six young people (17 per cent) – employed before the outbreak, stopped working altogether, most notably they are younger workers – aged 18 to 24 years.
  • Among those who thought that their education would be delayed or might fail, 22 percent were likely to be affected by anxiety or depression, compared to 12 percent of students whose education remained on track.
  • Young people whose education or work was either disrupted or had stopped completely being most twice as likely to be affected by anxiety or depression as compared to those who continued to be employed or whose education was not affected.
  • The new Coronavirus has left one in eight young people (13 per cent) without any access to courses, teaching or training — a situation, particularly acute among the youth in low-income countries and one that serves to underline the sharp digital divide that exists between regions.

The paper acknowledged that even before the onset of this crisis, the social and economic integration of young people was an ongoing challenge. Nevertheless, COVID-19 pandemic has disrupted every aspect of peoples’ lives, adversely impacting the demographic dividend. The paper cautioned, unless urgent action is taken right now, young people are likely to suffer severe and long-lasting impacts from the pandemic. Intriguingly, not many remedial measures in this space are visible just yet, not even in India.

A global rush to cling on to vaccines as a ‘safety belt’:

Amid such grim scenario, there exists an understandable global rush to cling on to get Covid-19 vaccines at an unprecedented record time, despite huge safety concerns of their users, if the development process is rushed through. The reason being, any previous vaccine development process has typically taken a decade or longer. Just to give a feel of it, according to reports:

Name of Vaccine

Number of years to develop

Varicella

28

FluMist

28

Human papillomavirus

15

Rotavirus

15

Pediatric combination

11

Covid-19 goal

18 months

Some countries promised even sooner:

Let me give two recent examples – one from India and the other from Russia.

According to the media news, Indian Council of Medical Research (ICMR) was planning to launch the Covid-19 vaccine by August 15 this year. Another report also indicated that on July 2, ICMR wrote to all 12 trial sites for the Covid-19 vaccine candidate - Covaxin, that all clinical trials had to be completed by August 15, in time for a public launch.

However, bioethics experts have questioned how all three phases of testing for a vaccine candidate, yet to even begin human trials, can be crunched into a timeframe of a month. Be that as it may, The Ministry of Science and Technology has since clarified that none of the Coronavirus vaccine candidates, including India’s Covaxin and ZyCov-D, are likely to be ready for public use before 2021.

Meanwhile, on August 12, 2020, Russia launched the world’s first registered COVID-19 vaccine ‘Sputnik V’ – again amid huge safety concern, as all three phases of clinical trials are yet to be over. This vaccine, apparently, will be first given to doctors and teachers after which there will be a mass vaccination campaign in October 2020. However, according to the Russian Health Minister, “Clinical trials of a Coronavirus vaccine developed by the Gamaleya Centre are over, paperwork is underway for the vaccine’s registration.”

Amid this rush, there comes good news. On August 10, 2020, the USFDA Commissioner assuredphysicians and other healthcare providers that vaccine and therapeutics approvals for the COVID-19 pandemic will be “based on good science and sound data.” And: “Nothing else will be used to guide our decisions,” he reiterated. By the way, six Covid-19 vaccine candidates from around the world are now in phase three of human trials.

Conclusion:

Currently, India is recording the highest count of fresh Covid-19 cases in the world while also reporting the most daily deaths from the virus. As on August 16, 2020 morning, the recorded Coronavirus cases in the country reached 2,590,501 with 50,099 deaths, despite all measures that the country is taking. The steep ascending trend continues, unabated. As I wrote on July 13, 2020 in this blog – what will be the ultimate fallout of this global health crisis, it will ultimately assume what form, when and how long? Similarly, clear reasons are not still available as to why many Covid-19 related catastrophic impacts in different nations, neither have any bearing on the degree of overall economic development of a country, nor how robust is the nation’s health care infrastructure, and the likes.

The answer to the question – Why many Covid-19 related things are happening, the way these are happening, even in India, continues to remain a paradox. Some experts are trying to attribute reasons to these, though, almost on a daily basis, which are also subsequently changing, as days pass by. In tandem, many significant collateral damages caused by the pandemic, are also surfacing, such as, weakening of an important growth pillar – demographic dividend, of a large country like India.

In the midst of all, the rush for a new Covid-19 vaccine development in a near impossible timeframe of around a year is gaining momentum. However, as the reports indicate, ‘despite the unprecedented push for a vaccine, researchers caution that less than 10 percent of drugs that enter clinical trials are ever approved by the Food and Drug Administration. The rest fail in one way or another: They are not effective, don’t perform better than existing drugs or have too many side effects,’ the report emphasized.

Incidentally, there doesn’t seem to be any other robust solution, either. On August 15, 2020, while addressing the nation on its 74th Independence Day, Prime Minister Modi said, ‘three Coronavirus vaccines are at different stages of testing in India and the government has a plan to ensure that a vaccine, when approved, reaches every Indian.’ The takeaway message from various developments on the global fight against the new lethal Coronavirus remains somewhat paradoxical. With the efforts to save lives and the livelihoods becoming more and more challenging, and the economic growth retarding faster every day, as it were. Thus, vaccines have to come sooner – but, no matter what?

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.

 

 

Shift from Disease Centered Care To Patient-Goals Directed Care In The New Normal

Posted on by
Reply

In the initial days of the first quarter of 2020, no one could fathom that just within the next 4 months over two million fellow citizens will get infected by an unknown virus, recording over 45,500 deaths. Many authorities may wish to project or analyze these Covid-19 numbers in so many different ways. Nevertheless, the fact remains, currently, in passing each day India is recording the highest count of fresh Covid-19 cases in the world, alongside the most daily deaths from the virus.

In the early days of Covid19 in India, many expected a remedial pathway to emerge soon – conventional or unconventional. Accordingly, Indian citizens across the country responded to the call of some national leaders by observing some – even unconventional measures, such as:

  • On March 22, 2014, to “boost morale” of doctors and public workers, as urged by the Indian Prime Minister, many people banged pots and pans on balconies across India.
  • On April 05, 2020, again responding to the Prime Minister’s passionate call, a large number of Indians turned off lights, lighted candles and Diyas hoping to dispel COVID-19 darkness.
  • On May 02, 2020, as organized by the Government, the country’s armed forces engaged in a nationwide exercise to express gratitude to doctors, paramedics, sanitation staff and other front-line workers involved in fighting the Coronavirus pandemic.

Gradually, the stark reality sank in, as the old normal faded out in the horizon. Public expectations arguably started shifting from heavenly interventions, as it were, to science-based measures. It has now been generally accepted that there is no alternative to social distancing and wearing a mask at the public places. These should continue, till the ‘silver bullet’ – vaccines arrive. More so, when going for herd immunity “cannot be a strategic choice or option,” given the size of India’s population, as the Government said.

Billions of people have now started hoping for the ‘silver bullet’ to come soon. This sky-high expectation continues to be fueled by media hype – based primarily by the Press Releases of the concerned companies. In the midst of these, comes a word of caution from the apex health body of the world. As recent as August 03, 2020, the World Health Organization (W.H.O) announced, ‘despite strong hopes for a vaccine, there might never be a “silver bullet” for COVID-19, and the road to normality would be long.’

To add some degree of certainty in this humongous – primarily scientific and logistical challenge to save lives, – pharma and biotech industry, as usual, are coming to the forefront. Billions of eyeballs are now glued on to them – following every bit of what they are saying – as the devastating impact of this health catastrophe is profound. Besides individual health, the fall-out of the pandemic is intimately intertwined with livelihoods, nation’s economy, social fabric and adjusting to the new way of living, including new mechanisms for most transactions.

Obviously, this would create a new normal – quite different from the old one – and naturally would include pharma business, as well. In this scenario, patients will assume a much different status, especially in the disease treatment process. More patients would likely to prefer their individual health-goals directed holistic care, which calls for a holistic disease treatment solution. The process needs to be contactless as far as practicable, less time intensive and above all cost effective

In this article, let me focus on this area. I reckon, many pharma players are also evaluating the impact of this shift to achieve business excellence in the new normal.

The current treatment approach and the pharma focus:

A recent paper, published in the JAMA Cardiology on the April 2016, made some interesting observations in this area. Citing cardiology disease area as an example, the authors noted the following, among other points:

  • Physicians’ decision-making process generally ‘concentrates on disease-specific outcomes, following practice guidelines for specific conditions.’
  • Value-based purchasing also largely focus on individual diseases.
  • However, disease-centered framework is ill-suited for persons with multiple chronic conditions, including older adults and the majority of adult health care users of all ages.
  • Disease-centered decision-making results in treatment burden when patients must adhere to multiple guidelines and harm when guideline recommendations conflict.
  • Furthermore, disease-centered recommendations may not address what matters most to these patients – varying health priorities.

The shortcomings of this approach from the patients’ perspectives, besides adding greater value for patients, prompt a need for change. From the current disease-oriented treatment approach, and pharma’s business-related focus in sync with this system.

Habit of visiting specialists at the very beginning complicates the process:

The disease-oriented treatment approach, as it is today, isn’t a legacy issue. In the good old days, General Practitioners (GP) used to examine their patients thoroughly – covering the entire body. Thereafter, depending on the specific areas of need, expert interventions used to be recommended.

However, todays well-informed people, equipped with health information of all kinds, can possibly figure out the broad outline of their health problems. Accordingly, many of them directly arrange appointment with specialists. As most of them are generally not terribly wrong in figuring out the problem areas, specialists’ treatment progresses in the same direction. Other existing health issues, not being of high priority treatment areas for persons concerned, could remain ignored, till these also flare up.

Undoubtedly this approach, even if is made ‘patient-centric’, in a broader sense, by pharma players, would cost more time, more money to patients. Besides, loss of income and increase in morbidity. This is certainly an avoidable situation for all – patients, doctors and pharma companies.

Go beyond ‘patient-centricity’ encompassing ‘patient-goals directed care’:  

The new focus should be directed towards ‘patient-goals directed care.’ This approach, which flows from a very old and a classic concept of  Sir William Osler articulated in the 19th century. This remains as relevant today for any holistic - ‘patient-goals directed care.’ It goes way beyond much hyped ‘patient-centric’ approach.

Sir William Osler once said, “The good physician treats the disease; the great physician treats the patient who has the disease.” The great physician understands the patient and the context of that patient’s illness. Accordingly, I reckon, pharma players new focus needs to be in conformance to this concept. It fits in so well with changing patients’ expectations in the new normal.

As has been evaluated in many studies, although, patient-goals directed care may appear to be particularly useful for persons with multiple chronic conditions, ‘this approach works across the age and health span, making it a compelling path toward value-based care from the patient’s perspective.’

‘Each patient represents a story’ which needs to be carefully deciphered: 

The article – ‘To Be a Great Physician, You Must Understand the Whole Story,’ published in the Medscape General Medicine on March 26, 2007, elucidated the point nicely. It said, each patient represents a story, which includes their diseases, their new problem, their social situation, and their beliefs. A physician needs to understand this story. Accordingly, perform a targeted physical examination based on the historical clues, order the correct diagnostic tests, and interpret them in the context of the history and physical exam. Once the appropriate data are collected, the patient’s story needs to be revisited, based on scientific data.

Revisiting process of the patients’ story includes making the correct diagnosis or diagnoses. The story must reveal the patient’s context – Who is this patient? – What is the patient’s goal? – How might the patient’s personal situation impact the treatment options? And more – as the above article highlights.

Each patient’s story’ is important for pharma companies, as well:

Patients’ disease related stories are of crucial importance to the pharma players, as well, for strategic reasons. Not just to gain insights on the disease manifestation process, but more importantly to facilitate a company’s engagement with them.

Another interesting article has brought out some more important issues in this area. The paper is titled, ‘Patient Centricity and Pharmaceutical Companies: Is It Feasible?’ It was published by the SAGE Journals on March 28, 2017, where the authors underscored, engagement with patients can only be possible, if there is credibility. Elaborating this point, the paper cited two GSK examples aimed at building trust with patients and physicians, as follows:

  • Change in marketing practices: In 2011, GSK eliminated prescription sales targets in the US and introduced a new incentive model for sales and marketing practices based on value and feedback from prescribers; external speakers/ convention travel support was discontinued (2016).
  • Clinical transparency: Since 2013 GSK has committed to promote transparency of clinical research and is a leading example in the pharmaceutical industry—it was the first company to grant access to anonymized patient data. The ‘All trial campaign (2013)’ commits to publishing all trial data; the GSK patient-level data access site has become a multi-sponsored portal (2014).

Conclusion:

As of August 09, 2020 morning, the recorded Coronavirus cases in India have crossed a staggering 2 billion mark, reaching 2,153,10 with 43,452 deaths. The figure keeps climbing – faster than expected, unabated.

The business relevance for a shift from the conventional disease centered care to patient-goals directed care, require deep understanding of the top pharma leadership along with its very purpose, in the new normal. Patients deserve this now, more than ever before, as explained above.

In my view, a changing mindset to align pharma business strategy – from providing a disease-oriented care to patient-goals directed care, is expected to improve patient outcomes manifold. Nevertheless, like what the above SAGE article emphasized, the organization at its end would require defining collectively and with clarity – why is this change now? How it is to be done – step by step?  And what are the results the company aims to achieve?

Consequently, it would help create a large pool of delighted and company loyal customers having strong ‘word of mouth’ advantages. Top pharma leadership’s ‘buying in’ this concept, with an appropriate organizational structure in place, would herald a new dawn of ‘Patient Value-Based Care’ – Convid-19 pandemic notwithstanding.

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.