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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.

Innovative ‘Medicines Too Damn Expensive’: Health Risk For Billions of People

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Most ‘medicines are too damn expensive. And a key part of the problem is the lack of consistent information about drug pricing. It’s not often that the Trump administration and the anti-poverty NGO Oxfam find themselves singing from the same hymn sheet.’ This was articulated in the article carrying a headline, ‘No One Knows The True Cost Of Medicines, And Blaming Other Countries Won’t Help,’ published by Forbes on March 03, 2019.

In the oldest democracy of the world, on the eve of the last Presidential election, Kaiser Health Tracking Poll, September 2016 captured the public anger on skyrocketing cost of prescription drugs, which they ranked near the top of consumers’ health care concerns. Accordingly, politicians in both parties, including the Presidential candidates, vowed to do something about it.

Ironically, even so close to General Election in the largest democracy of the world, no such data is available, nor it is one of the top priority election issues. Nevertheless, the discontentment of the general public in this area is palpable. The final push of election propaganda of any political party is now unlikely to include health care as one of the key focus areas for them. This is because, many seemingly trivial ones are expected to fetch more votes, as many believe.

In this area, I shall dwell on the ‘mystic’ area of jaw dropping, arbitrary drug pricing, especially for innovative lifesaving drugs – drawing examples from some recent research studies in this area.

High drug prices and associated health risks for billions of people:

New Oxfam research paper, titled: ‘Harmful Side Effects: How drug companies undermine global health,’ published on September 18, 2018, ferreted out some facts, which, in general terms, aren’t a big surprise for many. It highlighted the following:

  • Abbott, Johnson & Johnson, Merck and Pfizer – systematically hide their profits in overseas tax havens.
  • By charging very high prices for their products, they appear to deprive developing countries more than USD 100 million every year – money that is urgently needed to meet health needs of people in these countries.
  • In the UK, these four companies may be underpaying around £125m of tax each year.
  • These corporations also deploy massive lobbying operations to influence trade, tax and health policies in their favor and give their damaging behavior greater apparent legitimacy.
  • Tax dodging, high prices and political influencing by pharmaceutical companies exacerbate the yawning gap between rich and poor, between men and women, and between advanced economies and developing ones.

The impact of this situation is profound and is likely to further escalate, if left unchecked, the reason being self-regulation of pharma industry is far from desirable in this area.

As discussed in the article, titled ‘Why Rising Drug Prices May Be the Biggest Risk to Your Health,’ published in Healthline on July 18, 2018, left unchecked, the rising cost of prescription drugs could cripple healthcare, as well as raise health risks for millions of people. Although this specific article was penned in the American context, it is also relevant in India, especially for lifesaving patented drugs, for treating many serious ailments, such as cancer.

Is pharma pricing arbitrary?

The answer to this question seems to be no less than an emphatic ‘yes’. Vindicating this point, the above Forbes article says: ‘It’s a myth that the costs of medicines need to be high, to cover the research & development costs of pharmaceutical companies.’

Explaining it further, the paper underscored, ‘Prices in the pharma industry aren’t set based on a particular acceptable level of profit, or in relation to the cost of production. They’re established based on a calculation of the absolute maximum that enough people are willing to pay.’

The myth: ‘High R&D cost is the reason for high drug price’: 

Curiously, ample evidences indicate that this often-repeated argument of the drug companies’, is indeed a myth. To illustrate the point, I am quoting below just a few examples, as available from both independent and also the industry sources that would bust this myth:

  • Several research studies show that actual R&D cost to discover and develop a New Molecular Entity (NME) is much less than what the pharma and biotech industry claims. Again, in another article, titled ‘The R&D Factor: One of the Greatest Myths of the Industry,” published in this blog on March 25, 2013, I also quoted the erstwhile CEO of GlaxoSmithKline (GSK) on this subject. He clearly enunciated in an interview with Reuters that: “US $1 billion price tag for R&D was an average figure that includes money spent on drugs that ultimately fail… If you stop failing so often, you massively reduce the cost of drug development… It’s entirely achievable.”
  • In addition, according to the BMJ report: ‘More than four fifths of all funds for basic research to discover new drugs and vaccines come from public sources,’ and not incurred by respective drug companies.
  • Interestingly, other research data reveals that ‘drug companies spend far more on marketing drugs – in some cases twice as much – than on developing them.’ This was published by the BBC New with details, in an article, titled ‘Pharmaceutical industry gets high on fat profits.’

World Health Organization (WHO) recommends transparency in drug pricing:

The report of the United Nations Secretary-General’s High-Level Panel on ‘Access to Medicines’ released on September 14, 2016 emphasized the need of transparency in this area of the pharma sector. It recommended, governments should require manufacturers and distributors to disclose to drug regulatory and procurement authorities information pertaining to:

  • The costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval to each expense category separated; and
  • Any public funding received in the development of any health technology, including tax credits, subsidies and grants.

But the bottom-line is, not much, if any, progress has been made by any UN member countries participating in this study. The overall situation today still remains as it has always been.

Conclusion:

The Oxfam report, as mentioned above, captures how arbitrarily fixed exorbitant drug pricing, creates a profound adverse impact on the lives of billions of people in developing and underdeveloped countries. Let me quote here only one such example from this report corroborating this point. It underlined that the breast cancer drug trastuzumab, costing around USD 38,000 for a 12-month course, is almost five times the average income for a South African household. The situation in India for such drugs, I reckon, is no quite different.

To make drug pricing transparent for all, the paper recommends, “attacking that system of secrecy around R&D costs is key.” Pharma players have erected a wall around them, as it were, by giving reasons, such as, ‘commercial secret, commercial information, no we can’t find out about this’…if you question intellectual property, it’s like you’re questioning God.” The report adds.

In India, the near-term solution for greater access to new and innovative lifesaving drugs to patients, is to implement a transparent patented drug pricing policy mechanism in the country. This is clearly enshrined in the current national pharma policy document, but has not seen the light of the day, just yet.

In the battle against disease, life-threatening ailments are getting increasingly more complex to treat, warranting newer and innovative medicines. But these ‘drugs are too damn expensive’.

In the midst of this complicated scenario, billions of people across the world are getting a sense of being trapped between ‘the devil and the deep blue sea.’Occasional price tweaking of such drugs by the regulator are no more than ‘palliative’ measures. Whereas, a long-term solution to this important issue by the policy makers are now absolutely necessary for public health interest, especially in a country like 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.

Exigency of Cybersecurity in Digitalized Pharma

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Digitalization – as it unfolds and imbibed by most drug companies, is presumed to herald a whole new ballgame in the Indian pharma business. Equally significant is the quantum benefit that the process will deliver to pharma stakeholders – right from drug companies to patients. It has already hastened the process of new drug discovery and will also help charting newer ways to meaningfully engage with stakeholders, besides enhancing treatment outcomes for patients, appreciably.

However, the flip side is, more benefits a company accrues from digitalization, greater will be the risks of cyber-attacks. Thus, preventive measures should also be equally robust. Otherwise, hackers can bring a company’s digital system to a standstill, causing not just a temporary loss in revenue and profit, but also valuable data leak, with considerable impact on even long-term business.

Strangely, associated risks of digitalization to pharma companies are seldom outlined in any discussion, leave aside alternatives for salvaging such untoward situation, if or as and when it comes. Unless, it is felt that the scope of such discussion doesn’t cover the implementors and falls totally on cybersecurity experts.

Nonetheless, it is intriguing in the pharma space. The reason being, pharma industry believes, while talking about the efficacy of any drug, its vulnerability in terms of side-effects, contraindications or drug interactions, should also be known to its users. That’s the purpose of a packaging leaflet. It’s a different reason though, that most drug companies in India have virtually jettisoned this practice as a cost saving measure, even for drugs that are not under price control. That apart, in this article, I shall explore the relevance of cybersecurity in the digitalized pharma world.

A question that help understand its implication:

During organizational transformation through digitalization in pharma, just like any other business, all crucial documents get transferred from paper to digital formats. The key question that follows in this regard is – what happens to these digital documents post cyber-attacks, if any? Any attempt to answer this question holistically will help people realize its implication – that ‘cybersecurity must be more than an afterthought.’

‘Cybersecurity must be more than an afterthought’:

The article, ‘Cybersecurity in the Age of Digital Transformation,’ published by MIT Technology Review Insights on January 23, 2017, stressed upon this critical point. It highlighted: “As companies embrace technologies such as the Internet of Things, big data, cloud, and mobility, security must be more than an afterthought. But in the digital era, the focus needs to shift from securing network perimeters to safeguarding data spread across systems, devices, and the cloud.”

Thus, while discussing the need to digitally transform a company’s business, cybersecurity must be part of that conversation from the very start – the paper underscored in no uncertain terms. That’s exactly what we are deliberating today - ‘as companies embark on their journeys of digital transformation, they must make cybersecurity a top priority.’

The cybersecurity threat may cripple innovation and slow business:

Cisco explored the concept of Cybersecurity as a Growth Advantage by a thought leadership global study. While assessing the impact of cybersecurity on digitalization, it surveyed more than 1,000 senior finance and line-of-business executives across 10 countries. Some of the key findings, as captured in the Cisco report, may be summarized, as follows:

  • 71 percent of executives said that concerns over cybersecurity are impeding innovation in their organizations.
  • 39 percent stated that they had halted mission-critical initiatives due to cybersecurity issues.

Interestingly, 73 percent of survey respondents admitted that they often embrace new technologies and business processes, despite cybersecurity risk. However, as we shall see below, pharma executives are quite confident of cybersecurity, probably because of inadequate experience in this area, as on date.

Companies are struggling with their capabilities in cyber-risk management:

The paper published in the May 2014 issue of the McKinsey Quarterly journal, titled “The rising strategic risks of cyberattacks”, also flagged this issue. It said: “More and more business value and personal information worldwide are rapidly migrating into digital form on open and globally interconnected technology platforms. As that happens, the risks from cyberattacks become increasingly daunting. Criminals pursue financial gain through fraud and identity theft; competitors steal intellectual property or disrupt business to grab advantage; ‘hacktivists’ pierce online firewalls to make political statements.”

McKinsey’s research study on the subject, conducted in partnership with the World Economic Forum also upheld that companies are struggling with their capabilities in cyber-risk management. As highly visible breaches occur with growing regularity, most technology executives believe that they are losing ground to attackers. Its ongoing cyber-risk-maturity survey research also ferreted out the following important points:

  • Large companies reported cross-sector gaps in their risk-management capabilities.
  • 90 percent had “nascent” or “developing” ones.
  • 5 percent was rated “mature” overall across the practice areas studied.

Interestingly, the research found no correlation between spending levels and risk-management maturity. Some companies spend less, but do a comparatively good job of making risk-management decisions. Others spend vigorously, but without much sophistication. Even the largest firms had substantial room for improvement – McKinsey reiterated.

‘Corporate espionage’– a prime reason behind cyberattack on pharma:

An interesting article appeared in The Pharma Letter on July 18, 2017 on this subject. The paper is titled “Cyber-attacks: How prepared is pharma?” It said:“The pharmaceutical industry is a prime target for hackers. In 2015, a survey of Crown Records Management revealed that nearly, two-thirds of pharma firms had experienced breaches in data, and that one fourth of these same companies had been victims of hacking.”The paper also highlighted ‘corporate espionage’ as one of the prime reasons behind hacking.

In view of this, the author articulated that the need for pharma and healthcare companies to fortify their security systems has become clear in recent years. The best method of protection is to prevent cyber-attacks from happening, or at least reduce the risk of a hack, he advised.

Instances of cyber-attacks in pharma are many:

To drive home the point that when firms and other organizations fail to strengthen IT systems against attacks, they incur high costs -the above paper cited an example from the year 2016. It said: “The average global cost of data breach per stolen record was US$ 355 for healthcare groups, higher than losses in other fields such as education (US$ 246/record), transportation (US$ 129), and research (US$ 112).”

The author further emphasized that besides financial losses, pharma companies and other healthcare groups risk losing the trust of patients and other stakeholders. With the ongoing digitization in pharma, new threats may become even more pervasive and sophisticated. “Thus, investment in cybersecurity must be a priority, if pharma players are to protect their data and the data of their stakeholders”, he added.

Are pharma executives experienced enough on cybersecurity?

As reported by Pharma IQ on July 31, 2018, one of its recent surveys found that around 70 percent of senior pharma decision makers are “confident” or even “very confident” in their company’s IT security. But, digging deeper, the survey uncovered that:

  • 42 percent of respondents’ companies do not routinely follow IT security policies,
  • 49 percent said that the corporate risk profile is not firmly understood across all departments.

The survey concluded that this could potentially lead to gaps in the security process. To me it appears, this could, as well, be due to inadequate experience of pharma executives in this area.

But, investment in pharma IT is increasing:

The good news is, even in the current scenario, many pharmaceutical companieshave started making investments in IT solutions, in general. This is corroborated by the 2018 survey by Global Data. Some of its important findings are, as follows:

  • 79 percent of them are currently making investments in identity and access management (IAM) solutions
  • 72 percent are considering investment in the solutions over the next two years.
  • 75 percent of the respondents are currently deploying some form of backup, archiving, alongside content and web filtering solutions to store, as well as, preserve their online information. 

Conclusion:

In pharma perspective, digitalization of business promotes paperless culture. It radically changes the basic infrastructure of maintaining critical documents in the workplace. Digital document storage systems become the nerve center of information on the company. All data – strategic or related to operations – internally generated or acquired – right across all critical functional areas, such as IP, research, clinical trials, manufacturing, sales and marketing, finance, supply chain legal and even of the CEO’s office, find a space in this digital data sever.

Although, the benefits of digitalization are well known and much discussed, it has a contraposition, as well – related to the vulnerability of the system to cyber-attacks. This flags a demanding need for protection of digitally stored assets from cyber-attacks, or to frustrate even any misdemeanorfrom amateur hackers. Thus, creating an almost impregnable, well-firewalled digital data storage server assumes prime importance. Equally important is formulating and religiously implementing a robust digital policy for the same.

Creating strong awareness among employees and stakeholders regarding cybersecurity and involving them in tandem with a system-approach, sans an iota of complacency, is expected to mitigate such vulnerability, appreciably. Thus, a sense ofexigency for cybersecurity in the digitalized pharma world, I reckon, is very real.

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.

Relevance Of Outliers In Pharma Sales Forecasting

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Just like any other predictions or forecasting – on a broader sense, pharma sales forecasts are also a tough and tedious task. Availability of many sophisticated state of the art digital software tools and techniques, notwithstanding.

In an article, published in the July-August 2007 issue of Harvard Business Review (HBR), Paul Saffo – a forecaster based in Silicon Valley, California – expressed this point succinctly with a nice example. He said: “Prediction is possible only in a world in which events are preordained and no amount of action in the present can influence future outcomes. That world is the stuff of myth and superstition. The one we inhabit is quite different—little is certain, nothing is preordained, and what we do in the present affects how events unfold, often in significant, unexpected ways.”

At this point, I would respectfully prefer to slightly alter the last sentence of the quote as, “….and what we and (others) do in the present affects how events unfold, often in significant, unexpected ways.”  This is important to me, as we may have control over what ‘we do’, but may not have much control over what ‘others do’ in the present, which may also greatly affect how events unfold, often in significant, unexpected ways.

However, the author distinctly differentiates predictions from forecasts by clarifying that prediction is concerned with future certainty, whereas forecasting looks at how hidden currents in the present, signal possible changes in direction for companies. Thus, unlike a prediction, a forecast must have a logic to it and the forecasters must be able to articulate and defend that logic.

My own hands-on experience in the domestic, as well as the pharma industry of the western world tells me that the actual sales and profit may seldom be a replica of the respective forecasts for the same. However. a reasonably good forecast is the one that is much closer to reality.

That said, it is important to note in the same context, what the above HBR paper has said, in this regard. The author underscores whether a specific forecast actually turns out to be accurate is only part of the picture. Citing a nice simile it says, even a broken clock is right twice a day. Thus, the forecaster’s one of the key tasks is to map uncertainty where our actions in the present influence the future. Uncertainty is an opportunity, he articulates.

In this article, I shall try to explore the possible reasons why, despite the availability of so many sophisticated digital software tools and techniques, the reality in most cases is much different. In a significant number of occasions, the actual sales is much less than the sales forecasts.

The criticality of forecast accuracy:

As we know, sales forecasts today are generally data pooling or consensus forecasts for better buying-in by the implementer, as there exists a critical need, just not to deliver closer to the forecasts, but to exceed the same, especially for the new products.

One will get the flavor of criticality of sales forecast accuracy from the McKinsey research study titled, “The Secret of Successful Drug Launches”, published in March 2014. It found that two-thirds of the sample group of drug-launches failed meeting pre-launch sales forecasts in their very first year on the market. The sample for this study comprised 210 new drugs launched between 2003 and 2009, for which McKinsey gathered necessary consensus-forecasts data for launch from EvaluatePharma. Three important findings of this EvaluatePharma – McKinsey analysis may be summed up, as follows:

1. Actual sales during the first year of launch as % of sales forecast one year before launch:

  • % of launches below forecasts: 66
  • % of launches on or near forecasts: 8
  • % of launches exceeded the forecast: 26

2. Of launches that exceeded the forecasts in the year 1:

  • 65% continued to do so in the year 2
  • 53% of those exceeded forecasts in the year 3

3. Of launches that lagged forecasts in the year 1:

  • 78%continued to do so in the year 2
  • 70% of those lagged forecasts in the year 3

In an eloquent way, this study highlights the benefits of sales forecast accuracy for a sustainable performance excellence, especially with new products.

Wide room for improvement in forecasts:

Although, my focus in this article will be on sales revenue forecasts, there is a wide room for improvement in other related forecasts, as well.

Another interesting article titled, “Outsmart Your Own Biases”, appeared in the May 2015 issue of the Harvard Business Review revealed, when researchers asked hundreds of chief financial officers from a variety of industries to forecast yearly returns for the S&P 500 over a nine-year horizon, their 80% ranges were right only one-third of the time. The authors considered it as a terribly low rate of accuracy for a group of executives with presumably vast knowledge of the economy of the United States.

The study further indicated that projections are even further off the mark when people assess their own plans, partly because their desire to succeed skews their interpretation of the data.

Such a scenario prompts the need of yet greater application of a mix of creative and analytical minds to ferret out the reasons behind general inaccuracy in forecasting, which incidentally does not mean setting out an easy target, and then exceeding it. Right sales forecasting with high accuracy, is expected to make use of every potential future opportunity in the best possible way to achieve continuous excellence in performance.

Analyzing outliers in consensus forecasting:

A recent paper deliberated on this area backed by some relevant case studies to capture the relevance of outliers in consensus-forecasting for the pharma companies.

The 2017 study of EvaluatePharma, titled “The Value of Outliers in Consensus Forecasting” flagged some important points. It also asked, are we questioning the level of agreement or disagreement, while leveraging each estimate for consensus forecasts?

However, in this article, I shall highlight only on the relevance of outliers in pharma sales forecasting, and keep aside the question on the level of agreement or disagreement while leveraging each estimate for consensus forecasts, for another discussion.

As many of us have experienced, there will always be outliers in most of the consensus forecasting process, which are usually removed while arriving at the final numbers. Nonetheless, this article brings on to the table the importance of outliers who, on the contrary, can provide an insightful view, especially in those areas with more upside potential and downside risk.

Just to recapitulate, an outlier is a data point that lies at an abnormal distance from other data points, which in this case is data related to consensus-forecast. This divergence can be either very high or very low. Which is why, outlier removal is a common practice, as it is considered as bad data by many. Nonetheless, before singling out and elimination of outliers, it will be a good idea to analyze and understand the exact reasons behind the same.

The above paper also indicates that combining consensus forecasts with the analysis of outliers will enable the pharma companies:

  • To better balancing risk and upside
  • Improving accuracy of new product selection

Conclusion:

Just as in any business, for pharmaceuticals too, sales forecasting holds a crucial importance, having a far-reaching impact. This is primarily because, many critical decisions are taken based on sales forecasts, such as internal revenue and capital budgeting, financial planning, deployment of sales, marketing and other operational resources, including supply chain, to name a few. All these, individually and collectively, necessitate that sales forecasts, especially for new products, should be of high accuracy.

One of the recent trends in this area, is pooling or consensus forecasts, though, it is not free from some criticism. The recent EvaluatePharma study, as quoted above, clearly demonstrates that this approach helps increase forecast accuracy, especially in situations with a high degree of uncertainty.

The upper and lower bounds of consensus known as outliers, may often identify potential upside or downside events that could significantly affect the outlook of a pharmaceutical company.

With this perspective, it now clearly emerges that in-depth analysis of outliers is of high relevance to improve accuracy of pharma sales forecasts, in a significant way.

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.

Pioglitazone Conundrum: Should The Drug Regulator Step Over The Line?

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Recent order of the Indian drug regulator to withdraw all formulations of the well known, yet controversial, anti-diabetic drug – Pioglitazone from the domestic market has created a flutter in the country, ruffling many feathers at the same time.

Withdrawal of any drug from the market involves well-considered findings based on ongoing robust pharmacovigilance data since the concerned product launch. To ascertain long-term drug safety profile, this process is universally considered as important as the processes followed for high quality drug manufacturing and even for R&D.

A paper titled, “Withdrawing Drugs in the U.S. Versus Other Countries” brings to the fore that one of the leading causes of deaths in the United States is adverse drug reaction. Assessing enormity and impact of this issue, the United Nations General Assembly for the first time in 1979 decided to publish a list of banned pharmaceutical products that different countries may use for appropriate decisions keeping patients’ safety in mind, as they will deem necessary from time to time.

An interesting finding:

Quite interestingly, the paper also highlights:

“There are a number of pharmaceuticals on the market in the USA that have been banned elsewhere and similarly, there are some drug products that have been banned in the United States, but remain on the market in other countries.”

Different policies in different countries:

The reason for the above finding is mainly because, various countries follow different policies to address this important health related issue. For example, though the United States will withdraw drugs based on the decision taken by its own FDA, it will also compare the action taken by countries like, UK, Japan, Australia and Sweden on the same subject.

However, many experts do believe that United Nations must take greater initiative to make all concerned much more aware about the UN list of dangerous drugs, which should be continuously updated to expect the least.

Need transparency in pharmacovigilance:

Pharmacovigilance has been defined as:

“The task of monitoring the safety of medicines and ensuring that the risks of a medicine do not outweigh the benefits, in the interests of public health.”

An article on Pharmacovigilance by A.C. (Kees) van Grootheest and Rachel L. Richesson highlights as follows:

“The majority of post marketing study commitments are never initiated, and the completion of post marketing safety studies (i.e., phase IV studies) declined from 62% between 1970 and 1984 to 24% between 1998 and 2003.”

Thus, in many countries, due to lack of required transparency in the pharmacovigilance process, harmful drugs continue to remain in the market for many years before they are withdrawn, for various reasons.

The above paper strongly recommends, “While there might be monetary benefits for each country in keeping these drugs on the market, the U.N. must step up the visibility of the withdrawal of dangerous drugs list.”

Recent Pioglitazone withdrawal in India:

Recently in India, the Ministry of Health under Section 26A of the Drugs and Cosmetics Act, 1940 has suspended the manufacture and sale of Pioglitazone, along with two other drugs, with immediate effect, through a notification issued on June 18, 2013.

As per the Drugs and Cosmetic Rule 30-B, import and marketing of all those drugs, which are prohibited in the country of origin, is banned in India. Just as in the United States, the Ministry of health, while taking such decisions in India, compares long-term safety profile of the concerned drugs in countries like, USA, UK, EU and Australia.

A Parliamentary Standing Committee of India has already indicted the drug regulator for not taking prompt action on such issues to protect patients’ treatment safety.

Pioglitazone: the risk profile:

In India:

A leading medical journal (JAPI) cautions:

“Given the possible risk of bladder cancer, physicians have to be extremely careful about using pioglitazone indiscriminately in the future.”

The JAPI article continues to state:

“We require more robust data on the risk of bladder cancer with pioglitazone and Indian studies are clearly needed. Till that time, we may continue the use of this drug as a second or third line glucose-lowering agent. In all such cases, the patient should be adequately informed about this adverse effect and drug should be used in as small a dose as possible, with careful monitoring and follow up.”

In the USA:

In 2011 The US FDA as a part of its ongoing safety review of pioglitazone informed physicians and the public that use of this drug for more than 12 months is linked to an increased risk of bladder cancer.

The USFDA review is reportedly based on “an ongoing 10-year observational cohort study as well as a nested, case-control study of the long-term risk of bladder cancer in over 193,000 patients with diabetes who are members of the Kaiser Permanente Northern California (KPNC) health plan.”

Based on this finding US FDA directed that physicians should:

  • Not use pioglitazone in patients with active bladder cancer.
  • Use pioglitazone with caution in patients who have a prior history of bladder cancer, adding, “The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.”
  • Tell patients to report any signs or symptoms of “blood in the urine, urinary urgency, pain on urination, or back or abdominal pain, as these may be due to bladder cancer.”
  • Urge patients to read the pioglitazone medication guide.
  • Report adverse events involving pioglitazone medicines to the FDA MedWatch program.

The moot point:

Considering the above US FDA directives in the Indian context, the moot point therefore is, whether it will be possible for the drug regulator to ensure that physicians and the patients in India follow such steps for drug safety with pioglitazone?

In Canada:

Another new Canadian study has again reportedly linked Pioglitazone with risks of bladder cancer and cautioned, “physicians, patients and regulatory agencies should be aware of this association when assessing the overall risks and benefits of this therapy.”

Pioglitazone and its combinations banned in France and Germany:

After a government-funded study, tracking diabetics from 2006 to 2009, concluded that Pioglitazone increases bladder cancer risk, the French Medicines Agency (FMA) announced withdrawal of Pioglitazone along with its fixed-dose combination with Metformin, as well.

FMA also advised doctors to stop prescribing Pioglitazone, plain or in combination, and asked patients, who are on this drug to consult their doctors immediately.

Simultaneously, German health authorities also acted on similar lines.

An intriguing comment by the Indian drug regulator:

Keeping all these in view, it is indeed intriguing to note that the Indian drug regulator is reportedly open to re-examine the case of pioglitazone and revoking its ban in India, if strong scientific evidences emerge in support of safety and efficacy of the drug.

However, the question then comes up is what more new scientific evidences that the Indian drug regulator is now expecting, especially when the pharmacovigilance studies are almost non-existent in India?

Moreover, such comments of the drug regulator not only prompt raising doubts about the fragility and hastiness of his own decision of banning Pioglitazone in India, but also amply demonstrate lack of seriousness in his part on this extremely important decision on drug safety?

‘Drug Product Liability Claims’ in India virtually non-existant:

In most of the developed countries, appropriate regulations are in place for product liability claims.

Under this law, if any patient suffers injury in any form while administering  a pharmaceutical drug, the patient concerned is eligible to make pharmaceutical-drug-based product liability claims, which usually involve a huge amount of money by any imaginable standard.

These claims are based on:

  • Improperly marketed pharmaceutical drugs. This category includes:

- Failure to provide adequate or accurate warnings regarding a dangerous side effect.

- Failure to provide adequate instructions on safe and appropriate use of the drug.

- The “bad advice”, which may have been given by the manufacturer or by a doctor, pharmacist, sales rep, or some other medical provider.

In the United States drug safety and effectiveness related litigations reportedly also include:

-        Criminal and civil complaints brought by the U.S. Department of Justice.

-        Lawsuits brought by state Attorney Generals and private plaintiffs under state consumer protection acts and other causes of action.

In India, closer to the above system there is a law in paper, named as “Products Liability”. This law deals with the liability of manufacturers, wholesalers, distributors, and vendors for injury to a person or property caused by dangerous or defective products. The aim of this law is to help protecting consumers from dangerous or defective products, while holding manufacturers, distributors, and retailers responsible for putting into the market place products that they knew or should have known were dangerous or defective. However, in reality, there are hardly any damages slapped by consumers on to the manufacturers in India under this ‘Product Liability’ law.

It may sound however bizarre, but is a hard fact that many drugs in Fixed Dose Combinations (FDCs) had never even gone through any form clinical trials on human volunteers before they were for the first time allowed to be marketed in India by the drug regulators.

In absence of any active steps taken by the government to educate and encourage patients to make use of this law, patients, by and large, would continue to pay a heavy price for their ignorance, keeping their mouth shut all the way, while using:

- Defectively manufactured pharmaceutical drugs.

- Pharmaceutical drugs with dangerous side effects.

- And even improperly marketed pharmaceutical drugs.

As stated before, it is worth repeating, neither is their any functional pharmacovigilance system in place in India.

Drug product liability suit for Pioglitazone in the United States:

Just to cite an example, one report indicates:

“According to court filings, all of the Actos (Pioglitazone) lawsuits pending in the Western District of Louisiana allege Takeda Pharmaceuticals failed to provide adequate warnings to doctors and patients regarding the drug’s association with an increased risk of bladder cancer. Last month (April, 2013), the nation’s first trial involving Actos bladder cancer allegations ended with a Los Angeles Superior Court jury awarding $6.5 million to a plaintiff who was diagnosed with the disease after taking the drug for four years”. However, the judge overseeing the case granted Takeda Pharmaceuticals’ request to set aside the verdict.

The report also indicates, ‘more than 1,200 Actos bladder cancer claims are pending in the Louisiana litigation. Additional Actos lawsuits have been filed in state litigations in California and Illinois.’

Indian doctors and manufacturers protest together against Pioglitazone ban:

It is equally intriguing to note, despite serious life threatening side-effect and restricted usage profile of Pioglitazone, as established internationally through robust and large clinical studies, both the doctors and the Pioglitazone manufacturers in India are urging the government to lift ban on this drug immediately, keeping the silent patient community in the front line, as usually happens all over.

A news report highlighted that ‘doctors flayed the ban on anti-diabetes drug Pioglitazone and requested the Centre to reverse its decision in interest of patients.’

Another media report highlighted, major drug makers are strongly opposing the move of the government to ban Pioglitazone, in India.

Conclusion:

Without generating another set of robust evidence proving contrary to what has been already concluded in the United States and EU based on strong supporting pharmacovigilance data, if the Indian drug regulator revokes the ban of Pioglitazone, it will be construed as a huge compromise with patients’ safety interest with this drug.

This issue assumes even greater importance, when the ‘drug product liability’ system is almost dysfunctional in India.

The other alternative of the drug regulator is to revoke the ban, wilting under combined pressure of the manufacturers and doctors and ask for safety warnings trying to emulate, as it were, what has been done by the US FDA.  

In which case, with full knowledge that it is virtually impossible for any one to comply with the above US FDA requirements in India, will the drug regulator not step over the line, yet again?

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.