Cacophony Over Coronavirus Lockdown

Cacophony Over Coronavirus Lockdown

Currently, the entire India is trying hard to comply with the 21-day lockdown of the country, as communicated by Prime Minister Narendra Modi to the nation at 8 pm on March 24, 2020. The very next day,  while addressing his parliamentary constituency of Varanasi via video, he said, “the Mahabharata war was won in 18 days but this war against Coronavirus will take 21 days.”

After this announcement most people’s life, as I myself can feel it, has changed as never before in the past. Unlike the West, in India most of us are too much dependent on domestic help, for routine chores of the family. How difficult these are, at least, I never experienced in the past. Will life, in its entirety, ever be the same gain?

In addition, shortages of most of the essential items were felt everywhere, be these vegetables, grocery items or medicines. Leave aside, the non-essential necessities. But, the bottom-line is, the lockdown has to be followed. There isn’t any other effective alternative to protect ourselves, those working for us to make our lives easier and comfortable, our respective neighborhood and thereby our country. In its midst, a cacophony over this decision is palpable, whatever may be the reason. Many are from highly credible sources.

Exploring various facets of the cacophony, this article will dwell on the question that will arise at the moment of truth – on or after April 15, 2020: What happened after 21-day lockdown of the entire nation. I shall try to focus on this question with the most relevant facts.

The Government’s rationale behind 3 weeks lockdown:

As explained by the Prime Minister and later by several Indian experts, the rationale behind the 21-day lockdown will include primarily the following:

• The incubation period of Covid19 is around 5 to 14 days. This is also the potential transmission period of the microbe. Effective social distancing of all, may contain or even stop its spread.

• As all viruses can sustain or exist only by replicating, they are completely dependent on a host cell for survival and can’t reproduce outside a cell. Social distancing may help in this area, as well.

• Since, the world doesn’t have any vaccine for Covid19, as yet, prevention alternatives are limited.

Cacophony includes: Is complete national lockdown the only answer?

Several highly credible voices are asking: Is the complete lockdown of the nation the only answer? For example, Professor Vikram Patel at Harvard Medical School, wondered about the relevance of national lockdown in his article of March 26, 2020. He wrote, without any widespread community transmission of the disease, the Government might have staved off the worst without a sledge-hammer approach of national lockdown, which no country at India’s stage of the epidemic has imposed.

Elaborating the alternative approach, he suggested to intensify case finding approach through testing and contact tracing, quarantining those who are infected, physical distancing by everyone, graded travel restrictions, preparing the health system to cater to those who may need intensive care and protect health care workers. Even locking-down limited populations with community transmission will be prudent. When properly implemented these steps ‘could have stopped the epidemic in its tracks.’ Citing examples, he wrote, many of our Asian neighbors have done it successfully. Even China, the original epicenter of the epidemic, did not lock down the entire country.

According to other reports, as well, the countries, such as, Singapore, Germany, Turkey, Taiwan and China, have so far handled Covid19 much better than other countries in containing the pandemic. They all ‘refrained from imposing a complete, nationwide curfew-like lockdown.’ China did bring only the Hubei province under complete lockdown, but not the whole country. Scientists expect that Covid19 will exist despite lockdown – till an effective vaccine is developed and made available for all.

Are our doctors adequately protected against Covid19?

Today, even the doctors and other health care workers remain extremely vulnerable to the disease.  Even in AIIMS doctors, reportedly, are using masks and sanitizers made by themselves or buying them.…continue reading…

What A New Microbe Can Man Can’t?

What A New Microbe Can Man Can’t?

Our world is indeed so fascinating, where mankind is in possession of a predictable lethal power to annihilate fellow citizens of any country or countries – just in minutes or hours or days, as it would decide. Whereas, any sudden attack of an unpredictable crippling power of unknown microbes, can make the same mankind feel helpless – grappling to save lives of the citizens – along with its socioeconomic fabric.

Because of the sudden nature of such crippling attacks, mankind is put to fight against time to build a new arsenal of medicines and vaccines – while defending itself under an umbrella of preventive measures. It’s not that such a situation was never envisaged. On the contrary, as we shall see below, the warning from the same came from several credible sources. Even Bill Gates during a TED Talk five years ago had warned: “If anything kills over 10 million people in the next few decades, it’s most likely to be a highly infectious virus rather than a war – not missiles, but microbes.”

A few years later, the 2018 publication of the World Health Organization (WHO) – ‘Managing epidemics,’ articulated a similar cautionary note, which I am quoting in verbatim: “We are continuously learning about the unpredictable powers of nature. This is nowhere more true than in the continuous evolution of new infectious threats to human health that emerge – often without warning – from the natural environment.” Elaborating the point, it further cautioned: “Given the effects of globalization, the intense mobility of human populations, and the relentless urbanization, it is likely that the next emerging virus will also spread fast and far. It is impossible to predict the nature of this virus or its source, or where it will start spreading.”

Ironically, in about a year’s time, by end 2019, a new Coronavirus broke out in Wuhan of China. From January to March 22, 2020, 13,569 people, reportedly, died globally due to Coronavirus (Covid 19) infection. In India, as I write as I write during 14 hours long public curfew, 341 confirmed cases and 6 deaths have been reported. This outbreak has now shaken, almost the entire world – more than even before. The reverberation of the life-shattering impact of the disease, is now being felt and heard across all the facets of human life, including social, economic and political. Thus, the broad point to ponder in this article: Why the mankind can’t do what a new microbe can?

Various elements to it:

There are various elements of the above broad issue. A comprehensive response to which would involve, at least, two critical sub-questions:

• Was it avoidable? If so, to what extent?
• Or, at least, could its overall impact have been blunted?

Moving in that direction, let me try to explore some important facts that may help taking an unknown microbe bull by the horn, if such calamity strikes again – unannounced, in future.

None of these facts were unknown:

As we have seen above, the possibility of emergence and a sudden crippling strike of a new microbe was not unknown, including the warning of a global crisis from the W.H.O.  Besides, ‘nearly 50,000 men, women and children are dying every day from infectious diseases; many of these diseases could be prevented or cured for as little as a single dollar per head.’

Another interesting report: ‘Global rise in human infectious disease outbreaks,’ published in the Journal of the Royal Society interface on December 06, 2014, presents more facts. It says: Since 1980, over the last 30 years till 2014, outbreaks of infectious disease mostly caused by bacteria and viruses are steadily increasing with different health impact in different countries.

Several reasons for the high death rate related to infectious disease:

Several reasons could be attributed to high death rates for infectious disease, despite the availability of a large number of powerful antibiotics in the world, which include the following:

• Developing nations with lesser access to drugs.
• Fast development of Antimicrobial Resistance (AMR) owing to misuse and abuse of antibiotics.
• Emergence of new bacteria and viruses, such as, Covid19 catching the population off-guard, as is being warned by top experts, from time to time.

Several times in the past, I wrote on the subjects of access to medicine, Antimicrobial Resistance (AMR), as well as the recent Coronavirus outbreak. Nevertheless, for this specific discussion, I shall focus only on the second and the third points, in the reverse order, with a different perspective.

Fresh threats of new infections are ongoing:

As the 2018 paper of ‘Managing epidemics’, published by the World Health Organization (WHO) had articulated – besides new microbial pandemics, the history of previous viral outbreaks can also possibly repeat themselves. That means: ‘A new HIV, a new Ebola, a new plague, a new influenza pandemic are not mere probabilities. Whether transmitted by mosquitoes, other insects, contact with animals or person-to-person, the only major uncertainty is when they, or something equally lethal, will arrive.’

As these being ‘newer’ types – just as Covid19 is so different from…continue reading…

Setting A Cost Of Time That Patients May Gain From A New Therapy

Setting A Cost Of Time That Patients May Gain From A New Therapy

Since quite some, an intense ongoing debate about setting a cost of time, often by a few months, that patients could possibly gain from a new therapy for complex diseases. The answer still remains elusive.  Meanwhile, newer therapies for treating cancer, such as, Kymriah, priced at US$ 475,000, alongside several rare diseases, hit the market with jaw-dropping prices. The latest being - Zolgensma of Novartis, carrying a price tag of US$ 2.12 million – the most expensive treatment ever. This trend assumes greater significance as Bio – claimed as the world’s largest trade association representing biotechnology companies, and related organizations, across the United States and in more than 30 other nations, also makes some interesting points in this area.

This article will dwell on the relevance of this important issue, both in today’s and also in the future perspective. It will try to explore, why pharma and biotech companies are not keen to use a ‘transparent multi-factorial life-value calculator’, especially for prolonging life or curing an incurable disease, with a high-priced novel therapy.

Emotional ads to justify the trend, against tough practical questions: 

A part of a sleek looking advertisement from Bio, depicting the power of new therapies to prolong life, carries a headline – ‘Time. The Currency of Life,” followed by three emotive lines and two equally emotive questions: “Another decade with a spouse. A few more years with your best friend. A rich, fuller life rather than one cut short. How do we place value on these?” It then asks: “What is more precious? What is more priceless?”

Turning this emotive question on its head to a rational one, an article published in the Stat News on February 25, 2016 questioned: “How much is an extra month of life worth?” It asked the drug makers to calculate the same. The same article also quoted a Yale University economist and practicing radiologist asking: “It’s all well and good to just say life is priceless, but the reality is we are paying for it.”

Emotive ads try to justify funding towards innovation for such drugs:

The same advertisement, as above, while trying to indirectly justify such exorbitant drug costs, used yet another emotive note in its playbook. It emphasized: “By continuing to fund the innovation pipeline that has served us so well, we will be able to reduce the costs associated with modern-day health care.”

Such claims are being scientifically challenged – head on, by many important studies. To illustrate this point, I shall quote the following two, both were published in the JAMA Network. The first one in the JAMA Otolaryngology-Head & Neck Surgery and the next one in JAMA Oncology.

The first article is the ‘John Conley Lecture’, carrying a title, ‘Unintended Consequences of Expensive Cancer Therapeutics—The Pursuit of Marginal Indications and a Me-Too Mentality That Stifles Innovation and Creativity,’ appeared on December 2014. On innovative drugs of such genre, the paper concluded: “The use of expensive therapies with marginal benefits for their approved indications and for unproven indications is contributing to the rising cost of cancer care. We believe that expensive therapies are stifling progress, by:

• Encouraging enormous expenditures of time, money, and resources on marginal therapeutic indications and
• Promoting a me-too mentality that is stifling innovation and creativity.

The second article is an ‘original investigation, titled ‘Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated with New Cancer Medicines.’ It also underscored: ‘Although innovation in the oncology drug market has contributed to improvements in therapy, the magnitude and dimension of clinical benefits vary widely, and there may be reasons to doubt that claims of efficacy reflect real-world effectiveness exactly.’

Here again, the emotional appeal is being made by creating a ‘perfect World’ scenario. Whereas, scientific analysis of the innovative and high-priced drugs, reveals the reality for other stakeholders to take note of. Different pharma trade associations, although being a part of the same orchestrated effort, try differently to take the eyes off the humongous prices of new life-saving drugs. But many continue to believe that new cancer drug prices have long gone beyond control.

90 percent Biopharma companies do not earn a profit – A bizarre claim?

As is well-known, besides justifying high drug prices by highlighting ‘high R&D cost,’ drug manufacturers often say, as the Bio ad campaign makes an eyebrow raising claim – “Of the approximately 1,200 Biopharma companies in the United States, more than 90 percent do not earn a profit.”…continue reading…

Coronavirus Outbreak: Drug Shortage, Treatment And Unease – A Review

Coronavirus Outbreak: Drug Shortage, Treatment And Unease – A Review

The Coronavirus outbreak has reached a “decisive point” and has “pandemic potential”, said the Director General of the World Health Organization (W.H.O), reportedly, on February 27, 2020, urging governments to act swiftly and aggressively to contain the virus. He further added, “We are actually in a very delicate situation in which the outbreak can go in any direction based on how we handle it.” Alerting all, he appealed, “this is not a time for fear. This is a time for taking action to prevent infection and save lives now.”

As on March 08, 2020 – 106,211 coronavirus cases (view by country) were reported globally, with 3,600 deaths and 60,197 patients recovered. Thus, the most relevant question now is the level of preparedness of each country, to prevent a possible epidemic, which may even strike at a humongous scale. This will be relevant for both, the countries already infected with a coronavirus – in a varying degree, as well as, those who are still out of it.

From the drug industry perspective, equally pertinent will be to assess on an ongoing basis its impact on the medical product supply-chain and further intensifying ongoing efforts to find the ‘magic bullet’ – an effective remedy, partly addressing the unease of all, on this score. In this article, I shall try to ferret out the current status on these points, based on available and contemporary data.

The impact assessment has commenced:

While on the current impact assessment, I shall restrict my discussion on the largest pharma and biological market of the world – the United States (US) and of course, our own – India, starting with the former. On February 14, 2020, the US released a statement of the Commissioner of Food and Drugs Administration titled, ‘FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad.’ Highlighting the proactive actions of the regulatory agency, the statement recorded:

“We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages.” Adding further, he revealed that the US-FDA is in touch with regulators globally and has added resources to quickly spot “potential disruptions or shortages.”

Whereas in India, the Chemicals and Fertilizers Ministry has also announced: “The Government of India is closely monitoring the supply of APIs/intermediates/Key starting materials (KSMs) which are imported from China and the effect of the outbreak of a novel coronavirus in China on their supply.”

The current status:

As this is an ongoing emergency exercise, on February 27, 2020, by another statement, the US-FDA reported the first shortage of a drug, without naming it, due to the COVID-19 outbreak. It identified about 20 other Active Pharmaceutical Ingredients (APIs) or finished drug formulations, which they source only from China. Since January 24, the US-FDA has, reportedly, been in touch with more than 180 manufacturers of human drugs to monitor the situation and take appropriate measures wherever necessary. However, the prices of some key ingredients have already started increasing.

Back home, on March 03, 2020, Reuters reported, the Indian Government has asked the Directorate General of Foreign Trade (DGFT) to restrict export of 26 APIs and other formulations, including Paracetamol, amid the recent coronavirus outbreak. Interestingly, these 26 active pharmaceutical ingredients (APIs) and medicines account for 10 percent of all Indian pharmaceutical exports and includes several antibiotics, such as tinidazole and erythromycin, the hormone progesterone and Vitamin B12, among others, as the report indicated.

It is unclear, though, how this restriction would impact the availability of these medicines in the countries that import from India, especially formulations, and also China. For example, in the United States, Indian imports, reportedly accounted for 24 percent of medicines and 31 percent of medicinal ingredients in 2018, according to the U.S. Food and Drug Administration. Be that as it may, it still remains a reality that China accounted for 67.56 per cent of India’s total imports of bulk drugs and drug intermediates at USD 2,405.42 million in 2018-19. …continue reading…

UCPMP: Vacillating Between ‘The Perfect’ And ‘The Real’ World?

UCPMP: Vacillating Between ‘The Perfect’ And ‘The Real’ World?

In the ‘perfect world’ one takes ‘perfect decisions’, while in the ‘real world’ one takes a ‘real decision’ – as the saying goes. In tandem, a raging debate continues on what is ‘perfect’ and what is ‘real’, in the world we live in today. This may cause a dilemma to many, which seems to be all pervasive today. Understandably, many critical industry practices and processes are also a part of this quagmire. The pharma industry, the world over, including India, is no exception, where such dilemma and debates span across virtually all the business domains of the industry.

However, in this article, I shall focus only on one specific issue – alleged pharma marketing malpractices that continue unabated, regardless of severe punitive measures in many cases, from several parts of the world. Has it then become a universal ‘culture’ in this area? For greater clarity, let me start the ball rolling by trying to understand the line that differentiates ‘the perfect world’ norms from ‘the real world’ ones.

Understanding the ‘line’ between the ‘Perfect World’ and the ‘Real World’:

I reckon, in ‘the perfect world’ people develop ideal values, ethical standards and practices. The social, business and economic environments also encourage and promote an uncompromising value system that culminates into perfect and desirable behavioral traits for all. Consequently, there are no grey areas in the ethics and value judgement, especially regarding what is ‘right’ and what is ‘wrong’.

Whereas, in ‘real world’, the surrounding social, business and economic environment usually encourages and promotes self-serving interests, mostly from the shelter of ‘perfect world,’ as we shall see later. There also appears to be a flexibility in the overall value system – drawn around different guidelines, for preferred behavior and practices in most spheres of life. Consequently, one can spot many grey areas in that space, which are subject to different interpretation by different people. ‘Exceptions’ to the preferred behavior are also many.

As construed by many, one contemporary and broad example could perhaps be, the ethics, values and governance – enshrined in the Indian Constitution, arguably belong to the ‘perfect world.’ The same for ‘the real world’ is, what the majority of the population, including those who are governing the country demonstrate through words, deeds and action on the ground.

Living in ‘the real world’ – most expect others to practice ‘the perfect world’ norms:

Although, most people, including several different entities, actually prefer to live in ‘the real world,’ following commensurate practices and exceptions – generally expect others to practice ‘the perfect world’ norms – following commensurate ethics and values. Governments usually, try to exhibit that they want all citizens to be in ‘the perfect world’. However, under pressure of different nature, their policy enforcement arms keep maintain the status-quo of ‘the real world.’

Let me illustrate this point from the Indian perspective, with some recent examples related to the prevailing Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in the country. Here itself, we shall find, even the Government machinery vacillating between the both worlds.

Government vacillating between ‘both worlds’:

A recent media report related to the ongoing allegation on pharma marketing malpractices in India raised a controversy. It reported, on January 13, 2020 – ‘PM Modi warns pharma companies not to bribe doctors with women, foreign trips and gadgets,’ during his meeting with the senior officials from top drug-makers. This move was, reportedly, triggered by the report of “Support for Advocacy and Training to Health (SATHI)” – an NGO.…continue reading…

India’s Preparedness Against Biological Threats

India’s Preparedness Against Biological Threats

Recent Coronavirus outbreak poses a ‘very grave threat to the rest of the world’ – the head of the World Health Organization (WHO), reportedly said on February 11, 2020. Earlier, on January 28, 2020, it had changed the viruses’ risk-status from ‘moderate’ to ‘high’. As it creates a havoc in China, Coronavirus has recorded a limited spread in India, besides France, Canada, US, Japan, Thailand, Sri Lanka. This article will explore how prepared is India to tackle any similar biological threat to protect its citizens from a possible health catastrophe.

Let me begin by assessing pros and cons of the current initiatives of the Indian Government, both at the Center, as well as, in the States, in this regard.

The pros and cons:

Some of the ‘pros’, that the Ministry of Health and Family Welfare promptly initiated are as follows:

• Updated Travel advisory for travelers visiting China. 
• Discharge policy for suspected or confirmed novel Coronavirus (2019-nCoV) cases.
• Guidelines on Clinical management of Severe Acute Respiratory Illness (SARI) in suspect/confirmed 2019-nCoV cases.
• Guidance on surveillance for human infection with 2019-nCoV.
• Guidelines for ‘Infection Prevention and Control in Healthcare Facilities’.
• Guidance for sample collection, packaging and transportation for 2019-nCov.

The above steps are as commendable as some other prompt initiatives of the Ministry to stop Coronavirus from entering the country, such as leveraging technology for both thermal and symptomatic screening, especially at the high-risk airports.

However, according to global experts – India, along with several other countries are still ill prepared to face biological threats of a magnitude that we are now witnessing in China. On the other hand, according to February 12, 2020 publication of The World Economic Forum, there about a dozen of countries in the world who are best prepared for meeting similar health emergencies.

Similar calamity was predicted two years back by W.H.O: 

Interestingly, a similar situation was predicted by none other than Tedros Adhanom, Director General of the World Health Organization and was reported on February 15, 2018. He then said, “We have a problem. A serious one. At any moment, a life-threatening global pandemic could spring up and wipe out a significant amount of human life on this planet. The death toll would be catastrophic. One disease could see as many as 100 million dead.”

“This is not some future nightmare scenario,” he added. “This is what happened exactly 100 years ago during the Spanish flu epidemic.” Again: “A devastating epidemic could start in any country at any time and kill millions of people because we are still not prepared. The world remains vulnerable.”Explaining the reason for the same, the Director General pinpointed: “The threat of a global pandemic comes from our apathy, from our staunch refusal to act to save ourselves — a refusal that finds its heart in our indifference and our greed.”

Now, when the world is grappling with the menace of Coronavirus …continue reading…

An Essential ‘Acrobatic Feat’ Remains Relevant Even In Digital Pharma World

http://bit.ly/2UVX0c1An Essential ‘Acrobatic Feat’ Remains Relevant Even In Digital Pharma World

“A manager must, so to speak, keep his nose to the grindstone while lifting his eyes to the hills — quite an acrobatic feat!” This profound statement was articulated by the Management Guru of all-time – Peter F. Drucker, in his book named “The Practice of Management.” This book was published probably before many management experts of today were even born – in 1954. This epic quote of Drucker is in context of the critical requirement to harmonize management decisions affecting the short and the long-term strategic business goals.

While looking at the pharma industry from the above perspective, one may often find, the quality-time spent, especially by its marketers, on ‘lifting their eyes to the hills’ – looking for the early signals on critical changes in future success requirement – is often minimal. Most seem comfortable in ‘keeping their nose to the grindstone’ to deliver the short-term objectives, with a belief that the future brand success factors will replicate the present ones. Thus, honing the current strategies would automatically ensure achieving the long-term requirements.

This prompts a question, should pharma marketers predominantly concentrate on sharpening their traditional marketing tools for near-term excellence or reach out much beyond that? Today’s article will deliberate on this subject, in the context of changing market dynamics and consumer expectations in the today’s world.

Are the brand success parameters changing?

Scores of data-based assessments of progressive changes in the customer value trend, highlight significant shifts from the past, necessitating an overhaul of the value delivery parameters and the system – not just honing. More often than not, such reconditioning could even be disruptive in nature – as may happen with the change to a well-integrated digital marketing system.

For example, until recently pharma brands used to be differentiated primarily based on its intrinsic key features and benefits, like efficacy and speed of recovery, safety and side-effects profile, ease of compliance and nature of drug interactions during concomitant use and more. Today, the parameters of brand differentiation have gone much beyond that, which could have been captured by an astute marketer while ‘lifting his eyes to the hills’, alongside ‘keeping his nose to the grindstone.’

The evolving parameters of brand-differentiation are not just restricted to the features and benefits, but call for unique customer value creation – such as providing a unique treatment experience to patients – understanding their needs, expectations and preferences. This, in turn, change the traditional pharma marketing ball game, as the success ingredients are so different.

Capturing, conceptualizing and delivering customer value, following the traditional pharma marketing tools and processes will increasingly be a daunting task. New digital tools and platforms – well-integrated into the evolving pharma marketing processes, would be necessary to win customers’ share of mind, more effectively than ever before. Nevertheless, value delivery still remains at the core of the pharma marketing system.

Value delivery still remains at the core – with significant changes: 

Value delivery will always remain the core purpose, and a constant factor in pharma marketing initiatives. It was so in the past, is at present, and will continue to be in the future, regardless of changes in the market and customer dynamics.…continue reading…