Tag Archives: Outbreak

Changing Doctors’ Practice Dynamics With Covid-19 And Beyond

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Unexpectedly, the answer to an onerous question surfaced just around a year’s time. In my article on this blog, written on April 08, 2019, I raised a question – “Would ‘Connected Healthcare’ Catch Pharma Players Off-Guard?” Interestingly, an unexpected and abrupt turn of events in the global healthcare space, including India, triggered by Covid-19 pandemic, signals an early dawn of an evolving reality, related to ‘Connected Healthcare’, in India.

Never ever, I reckon, the Government realized so well that continuation with a fragile public healthcare infrastructure is self-defeating for the country. Allocation of financial resources, at least 2.5 percent of the country’s GDP, for its rejuvenation – powered by AI-based modern digital technology, would help avoid overburden on the healthcare system. This will mean, saving more lives and also a significant reduction of morbidity, especially in a situation, like Covid-19 pandemic. Good health can propel good economy, more effectively.

That’s why, ‘connected healthcare’ – by effectively linking requisite ingredients of all health-related information that medical professionals and the patients would need, appears to be the new reality. This process is being facilitated by rapid acceleration of usage of various digital platforms, by both healthcare consumers and providers. Thus, it is becoming increasing clear now that leveraging digital technology with innovative mindset and a fresh pair of eyes, will be the way forward, in India, as well. It seems very likely, when considered from two angles:

  • What several research data reveals about an increase in usage of digital platforms by healthcare consumers and providers, before and during Covid-19 pandemic. Especially because, this struggle appears to be for a long haul.
  • Most countries are currently struggling to navigate through highly contagious Covid-19 outbreak and simultaneously trying to chart a workable pathway for avoiding similar eventualities in the future.

In this article, I shall try to focus on Covid-19 induced changes in doctors’ practice dynamics – based on research studies, while revisiting the subject on ‘connected healthcare,’ and its relevance now – also in the years ahead.

Research studies capture a new and growing awareness: 

The recent findings from the “Digital Doctor 2020” survey, which is a ‘21-country study of Doctors’ perspectives on digital and connected health, highlight some interesting points. This study was conducted just before the global outbreak of Coronavirus. Some of its findings were also deliberated inan article published in the PharmExec.com on April 23, 2020. The paper is titled, ‘How Prepared Were Physicians for the COVID-19 Digital Upswing? Some of the key points, as reported, are worth noting:

  • Although, the awareness of drug prescribers of different digital technologies related to healthcare is high, how these technologies work in healthcare was unknown to many doctors at the time of the Digital Doctor 2020 survey. It came out that clear benefit statements, will be welcomed when there is such a steep learning curve.
  • Regardless of face-to-face interactions still remaining preferred choice before the pandemic, online channels are on the rise and accelerating with COVID-19 lockdown.
  • Benefits of using connected health devices for patient management and treatment are widely recognized and is believed to play a key role in the future. The respondents agree, even their patients are now more interested in their own health data, as they are gaining control over their weight, diet and physical activities.

Highlighting that their research data over the last few weeks showing increasing usage of digital solution to respond and adapt to the new realities of Covid-19 pandemic, the author of the article concluded: ‘For a long time, digital solutions have often been considered an option; now they have become a necessity.’ To understand the emerging scenario, let us now look at the preferred communication channels of the doctors – pre-Covid-19 outbreak. 

Preferred channels of doctors pre-Covid-19 outbreak:

According to the Ipsos survey of pre-Covid-19 outbreak, face-to-face communication with Medical Representatives (MR) used to be the most favored channel of the doctors, as follows:

Channel Med. Rep Speaker Program Conf. E-detail Journal Ads Med. Liaison E-mail Direct mail Pharma website
Pref. % 35.2 11.7 10.0 8.4 8.4 8.8 8.4 5.0 4.1

However, on April 14, 2020, Ipsos shared the results of their interim research conducted, together with M360, among doctors, conducted during Coronavirus outbreak. The preliminary findings indicate, Covid-19 will permanently alter physician practice dynamics. A clear shift in the engagement model with them – away from in-person detailing, throws several significant questions on the traditional physician engagement template of the pharma players.

It also signals another fundamental change in the physicians’ practice dynamics, as Covid-19 seems to have changed practicality of having face-to-face communication between the representatives and doctors, as before. This situation makes ‘connected healthcare’ a reality – as we move deeper into the everyday- evolving scenario.

Some unexpected and significant changes surfaced in a month: 

The above research also flagged, the following two important changes, among several others, triggered by the Coronavirus outbreak:

  • The mean number of sales representative visits dropped from 15.7 before the Coronavirus outbreak to 1.3 in just the following month, during the pandemic 
  • Overall preference and effectiveness of e-detailing also improved, significantly, where any non-personal communication and interaction with drug companies, either through sales representatives or by others, were considered as e-detailing. 

This brings me back to the question, how are doctors feeling about this never before shift in their practice dynamics?

How are doctors feeling about a never before shift in their practice dynamics?

The ongoing research on this critical area captures a new reality, where many doctors, especially those who are not directly engaged in combating the Covid-19 pandemic, are clearly feeling a shift in their practice dynamics. Curiously, the new feeling of a shift also includes, the way these doctors interact with different drug companies, mostly through their Medical Representatives.

These inklings of the doctors are expected to get translated into some fundamental changes in the real-life situation, as we all sail through the life-changing time caused by Covid-19. Especially, considering the requirements of a new normal – social distancing, wearing a mask always while on outdoor, and several other norms as prescribed from time to time.

‘Connected healthcare,’ is expected to take its place on the center stage:

In this situation, ‘connected healthcare,’ which used to be more discussed than practiced, is expected to take its place on the center stage. It is necessary in the present situation for remote consultations, primarily for chronic ailments – for effective disease management and treatment. More so, as in the current situation individual health awareness of a large population, even in India, is increasing with an accelerated speed, perhaps more than ever before.

Thus, this is the right time to focus on ‘connected healthcare’, powered by AI-based digital technology. It has immense potential to help the Indian population getting immediate medical attention at a lower cost, with an improved access, for all. Though these are early days, it appears the ball has started rolling in the right direction, as the recent draft guidelines of the Indian Council of Medical Research (ICMR) indicates: ‘Patient can WhatsApp, SMS or email consent for Covid-19 clinical trials.’

Conclusion:

Still today, there is no sign of even temporary flattening the disease progression curve in India. As on May 10, 2020 morning, the recorded Coronavirus cases continue to climb sharply to 62,939 with 2,109 deaths, which is rising in India faster than most other countries. On May 07, 2020, AIIMS director again warned that Covid-19 pandemic is yet to peak in the country. “According to modeling data and the way our cases are increasing, it is likely that peak can come in June and July,” he added.

But is it getting worse? Despite stringent lockdown, there has been a surge in cases, which can also be attributed to higher levels of testing. However, from a doubling rate of 11.5 days on May 3, it has shortened to 10.3 days, which means that cases are doubling in quicker time. Each set of 10,000 cases is now increasing at a more rapid pace than the preceding set, highlighted an editorial of a leading news daily.

With a vaccine still elusive, the government had been banking mostly on the lockdown to break the chain of transmission of the virus. Meanwhile, the World Health Organization (WHO) has said: ‘Deliberately infecting healthy people with Coronavirus may speed Covid vaccine studies,’ reflecting more uncertainties in this area. It is also not likely that the country will cease to have any problems with its fragile public healthcare infrastructure and delivery system, even after flattening the disease progression curve.

Along with many other Covid-19 induced life-impacting changes, doctors’ practice dynamics are also expected to undergo a metamorphosis, lasting for an indefinite period. Consequently, I reckon, it’s about time, even for the pharma industry to voluntarily adopt ‘connected healthcare’ as a future way of life. One can get a glimpse of it in the Covid-19 clinical trial draft guidelines of the ICMR. Nonetheless, ‘connected healthcare’ comes with a clear signal of reducing the cost of healthcare and improved patient access, having the potential to effectively mitigate a sizeable part of the precipitated healthcare crisis, caused by Coronavirus.

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: Some Unanswered Questions in India

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Ending all speculations, the national lockdown 2.0 with all previous stringent provisions and more, expecting to bring the deadly microbe under a tight leash in India, commenced on April 15, 2020. This is expected to continue till May 03, 2020, keeping a window of opportunity open, for a case by case review, after April 20, which is today. This is now a known fact. But what is still not known to many are the answers to some critical question, such as, the following three, for example:

  • Will the standalone plan for strict compliance of prescribed social distancing norms for over 40 days and possibly much beyond, a comprehensive strategy to end the Covid 19 warfare in India?
  • As this game plan to save lives also involves livelihood of a large population, will it lead to hunger, involving many families?
  • When will the Covid19 nightmare end in India and how?

In this article, let me deal with these three questions, with illustrations.

Is social distancing’ alone a comprehensive strategy?

Experts believe that ‘social distancing’ is undoubtedly one of the key strategic components in the war against the invisible enemy Covid 19, especially to contain the spread of the virus. However, it’s not considered a standalone or a comprehensive strategy to win Covid19 warfare, for good, as it doesn’t help identify asymptomatic individuals – potential candidates for the continued spread of Coronavirus.

What scientific studies reveal?

Covid19 testing strategy in India is mainly focused on foreign returned and symptomatic individuals, alongside contact tracing. Interestingly, the study on the Covid19 outbreak in China, published by Nature Medicine on April 15, 2020, concluded – 44 per cent of those who tested positive, contracted the disease from an asymptomatic person. This happens, as the viral shedding, that can infect another individual, takes place, at least, 2-3 days before symptoms manifest.

Thus, along with containing the spread, it is equally important to trace the asymptomatic individuals at an early stage, then isolate and quarantine them at appropriate facilities, as necessary. Accordingly, many countries follow intensive testing guidelines from an early stage of disease spread. South Korea, for example, has been successful in this area, during the first wave. The same is being followed in the subsequent waves of outbreaks, till an effective antidote, like a vaccine is available to end the war. Hence, this is considered as a comprehensive strategy in the interim period. It was also well discussed and captured by the Indian media.

Lockdowns delay the peaks by about three months:

Experts indicated, ‘lockdowns merely delay the outbreak’s peak by about three months.’ They have also cautioned: ‘Asian countries risk new waves of Coronavirus infections when they lift lockdowns. The same could happen in the rest of the world.’ The world is now witnessing the second wave of outbreak in many countries.

Two seemingly contradictory messages surface:

Going by the ICMR data, according to media reports, India has conducted around 160,000 tests as on April 8, 2020 with the country’s tally of positive cases stands at 6,237 (at 6 pm on April 9). This indicates, 3.8 percent of the tests yielded positive results for Coronavirus. In comparison, the US with a much lesser population than India, has conducted 2.2 million tests. This is the highest among all countries, and a fifth of all those tests throwing up positive results.

An analysis by Worldometer  Get the data  Created with Datawrapper, of Covid-19 tests per capita of the top ten countries, by the number of tests conducted along with India, reveals something interesting. With a population of around 1.3 billion, India’s Covid-19 tests per 10,000 population has been merely 0.04. This is perhaps one of the lowest, especially considering India’s vast population with high density, poor living conditions of a large number of people, besides other risk factors.

Curiously, even the ICMR acknowledged on April 15 that it is critical to increase testing for Covid-19, as the number of cases in India is “rising exponentially.” However, on April 16, 2020, the Government again defended its testing strategy, as Coronavirus cases in India crossed the 13,000 mark on that day.

Didn’t India get a space to ‘buy time’ in 21-day lockdown period?

It was widely expected that the 21-day national lockdown was announced to buy precious time to prepare the country to roll out a comprehensive strategy. This was expected to include, identification of the asymptomatic individuals or persons with very mild symptoms, through intensive testing. Isolation and quarantine these individuals are of immense importance, thereafter, as the situation will demand.

But, why this hasn’t happened that way, as yet, by garnering requisite wherewithal, from – before, during the 21-day national lockdown period, to date, remains an unanswered question.

Will lockdown 2.0 lead to hunger in many poor families?

Dr. Amartya Sen, the Nobel Laureate and the Harvard University professor  explained the situation in an article, published on April 08, 2020. He wrote: “If a sudden lockdown prevents millions of laborers from earning an income, starvation in some scale cannot be far off.” Even the US, which is considered a quintessential free enterprise economy, has instituted income subsidies through massive federal spending for the unemployed and the poor, Professor Sen wrote.

The current situation was anticipated by global experts, well before it surfaced:

Even before it surfaced so strikingly, Professor Sen cautioned, the more affluent may be concerned only about not getting the disease, while others have to worry also about earning an income, which may be threatened by the disease or by an anti-disease policy, such as a lockdown. For those away from home, such as migrant workers, finding the means of getting back home, could also be a huge emotional concern that needs to be addressed with empathy. The emerging situation in this regard, also increases the risk of disease spread in various different ways.

Another renowned economist, Professor Ricardo Hausmann at Harvard University has, reportedly, said, further lockdowns could have dire consequences. Strict social-distancing measures mean that people must stay at home, so many cannot work, particularly those on a daily wage. Developing nations, such as India, do not have much financial flexibility to pay, for these migrants to stay at home for long, he added. Let me hasten to add, India has already announced a financial package for this purpose. But…

Would the announced stimulus package mitigate the economic and social needs?

1.7 trillion rupees (US$ 22.6 billion) stimulus package that India has announced for the poor, is termed modest by the economists, considering the population of the country. India has to weigh the numbers of deaths that will be caused by the loss of livelihoods against those caused by the disease. “For those who have to stay at home, they starve to death,” Professor Hausmann said.

Thus, the question of charting a clear pathway – striking a right balance between life and livelihood, in the face of Coronavirus pandemic in India, also remains an unanswered question.

When will Covid19 nightmare end and how?

It is virtually impossible to win the war against Coronavirus, decisively, only through social distancing as a standalone strategy. Even ‘The Lancet (Infectious Diseases)’ study of March 23, 2020, concluded: “In the absence of any pharmaceutical intervention, the only strategy against COVID-19 is to reduce mixing of susceptible and infectious people through early ascertainment of cases or reduction of contact.”

‘Early assessment of cases or reduction of contact’ will call for a comprehensive strategy-mix of social distancing – intensive testing of asymptomatic individuals – isolation and quarantining those who will test positive. The paper also underscored: “The effectiveness and societal impact of quarantine and social distancing will depend on the credibility of public health authorities, political leaders, and institutions. It is important that policy makers maintain the public’s trust through use of evidence-based interventions and fully transparent, fact-based communication.”

‘If’ and ‘but’ exist:

Interestingly, in the ‘The Lancet’ study, the authors estimated that 7·5 percent of infections are clinically asymptomatic. Whereas, the study published in Nature Medicine on April 15, 2020, concluded that 44 per cent of those who tested positive contracted the disease from an asymptomatic person.  Moreover, The Lancet paper acknowledged that higher asymptomatic proportions will influence the effectiveness of social-distancing interventions. But, the question remains, when will Covid19 nightmare end and how?

Primary ways to end the war:

This issue has been deliberated with scientific reasons in many articles. One such is titled, ‘Herd immunity is the only way the Coronavirus pandemic will end — and it would require a vaccine. Here’s how it works.’ This was published in the ‘Business Insider,’ on April 14, 2020. Like other papers, it also reiterated that individuals could gain immunity to the new Coronavirus, if they develop antibodies. This can happen, primarily in two ways:

  • Herd immunity or after people get infected and recover
  • Vaccination

According to Gavi, herd immunity is the indirect protection from a contagious infectious disease that happens when a population is immune either through vaccination or immunity developed through previous infection. Even people who aren’t vaccinated, or in whom the vaccine doesn’t trigger immunity, are protected because people around them who are immune can act as buffers between them and an infected person. Once herd immunity has been established for a while, and the ability of the disease to spread is hindered, the disease can eventually be eliminated, e.g., eradication of smallpox.

However, many scientific papers indicate that pursuing herd immunity through infection by allowing the virus to spread, rather than through a vaccine, would lead to hundreds of thousands more deaths. Moreover, some evidence indicates that a recovered person’s immunity may not be permanent. Hence, developing immunity through vaccination will always be a prudent choice.

Although, how fast an effective vaccine will be available for mass vaccination remains a key question,the good news is, a British scientist who is developing a Coronavirus vaccine, expects it to be ready by September, 2020. Meanwhile, I reckon, a disease specific antiviral drugs will be available to treat the infected persons and prevent death.

Conclusion:

Many of us in India, at various times, behave in a difficult to understand or even a mutually contradictory way. For example, at the call of crisis leadership in the country, in the midst of a Janata Curfew on March 22, 2020, people clapped or got engaged in beating pots and pans from their respective balconies, together at 5 pm. This happened with a huge participation, ‘as a mark of respect for the frontline health workers and medical professionals who were working day and night to contain the COVID-19 pandemic and selflessly treating patients who are affected by it.’ Later on, the same health care professionals and workers were assaulted, abused and even stigmatized, as they try hard to fight the virus. Intriguingly, many of the same people earlier participated in beating pots and pans to show respect for them.

Similarly, ‘citizens across the country lit Diya, Candles and flashed their mobile and torch lights on Sunday following our Prime Minister’s appeal, for a 9-minute blackout to dispel the “darkness” spread by Coronavirus.’ Ironically, in later days, many of these people – from the super rich to poor, acted in contrary to this purpose, for totally different reasons. This happened. But, understanding why it happened in India – right from the call – to its immaculate execution and the contradiction that followed on the ground, is a complex task for many. Perhaps, as complex to understand as, why containing the Coronavirus disease spread, through social distancing alone, is being considered as the only way to win the war against Covid19.

All countries in the world, as the experts say, will reach and pass the peak of the first wave of Coronavirus outbreak at some time. This will possibly not mean the end of the Covid19 war, before a vaccine is available. Thus, long term protection of people against Covid19, in the shortest possible time, is the name of the game. In the midst of these, life moves on – with some critical questions still remaining unanswered. Nonetheless, the resolve to fight and win this war, against an invisible enemy, be it only through social distancing, or with a more comprehensive and scientifically explainable strategy and ultimately a vaccine, continues to linger.

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.

Acid Test For Excellence in Crisis Leadership

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On April 12, 2020 – in the morning of the day 19 of the national lockdown, India’s total number of Coronavirus positive cases reached 8,504 with 289 deaths. The country’s trajectory is reportedly  steeper than most Asian peers, such as Singapore, Japan, and Indonesia. Incidences of new infections and deaths are also rising faster. The report also highlighted a possible link between number of tests conducted and the number of confirmed cases across the States. The aggregated impact of Covid19 outbreak has created an unprecedented health, social and economic calamity, changing everybody’s life – now and beyond.

However, going by Prime Minister Modi’s announcement on March 24, 2020, the national lockdown to contain the pandemic should continue till April 14, 2020. But, the above scenario is creating a huge dilemma within almost all Coronavirus crisis management leadership in the States, with the final decision resting upon the Prime Minister of India. Meanwhile, on April 09, 2020, Odisha government decided to extend the lockdown until April 30, followed by Punjab, Maharashtra, Karnataka and Telengana on April 11, 2020. However, all will get to know India’s decision in this regard for the rest of India, as you read this piece today.

The top leaders of Asia, Europe and American continents are handling the grave situation differently, with a varying degree of success, so far. Everybody is watching different world leaders in action – each trying hard to gain control over the unprecedented crisis, making it an acid test for excellence in Crisis Leadership.

Three different types of needs for the country:

As I see, three specific types of needs of three specific classes of people in the social milieu, are emerging in India:

  • Only need is to save life from the disease, with not much problem in procuring other essential requirements – having enough wherewithal to pull through the critical period, better than most others.
  • Strong need exists to save life, but facing tough challenges in arranging for essential needs for daily living.
  • Need to save life, but feel desperate for the means of livelihood – to protect family and defendants from hunger, in a seemingly uncertain future.

In the current situation, while trying to contain the spread of pandemic effectively, the sufferings of especially, the second and third group, as stated above, also need to be addressed, ‘and this is much aided by a participatory democracy.’

An acid test for crisis leadership at the top:

The situation isn’t just a war against Covid19, but much beyond that. The Nobel Laureate Professor Amartya Sen at Harvard University  explained the situation so well in an article, published on April 08, 2020. He lucidly illustrated, that the needs of people in a natural calamity, such as Coronavirus caused a pandemic, are different from a conventional war – against an enemy country. Desirable leadership qualities are also significantly different.

As Professor Sen wrote, while managing a crisis situation during a conventional war, ‘a leader can use top-down power to order everyone to do what the leader wants – with no need for consultation.’ But, managing a crisis during a natural calamity, a leader should demonstrate skills for a ‘participatory governance and alert public discussion.’ Listening to public discussion makes the top leadership understand what needs to be done by the policy makers.

Another paper, titled “Steering Through the Storm,” published in the ‘People + Strategy’, also reiterated the same with different words. It emphasized, “during a crisis, like natural calamity, leaders should engage actively with their constituents whenever possible, distinguishing critical issues from less pressing needs, communicating risks, and maintaining readiness. Throughout the crisis, leaders should remain accessible and open to new sources of information, and take care of their own needs when necessary and appropriate.”

How different countries are demonstrating crisis leadership:

Like other countries, crisis leadership is now clearly visible even in India – right from 1 day ‘people’s curfew’, to the announcement of 21-day national lockdown for Covid19 outbreak. An interesting article, published in Forbes on March 10, 2020, deliberated on what China, Italy and the United States teach us about crisis leadership. These examples give a sense of how different countries, facing similar but country-specific problems with Covid19, reacted with remarkable ‘different approaches and results.’ I am paraphrasing below some recent illustrations on crisis leadership, as captured in the above paper:

China: China was the first country to face this calamity beginning in Wuhan of the Hubei province. With command and control leadership and decisive action China was able to immediately to garner and consolidate all its resources for an aggressive response. The World Health Organization called it as, “perhaps the most ambitious, agile and aggressive disease containment effort in history.” This includes closing down manufacturing sectors, sharing information widely, executing mass testing and quarantining millions of people. The Chinese government made the decision to absorb a significant economic cost to contain COVID-19 rather than potentially lose control and the result was effective - the number of new cases has steadily decreased in weeks’ time.

However, the downside of this type of leadership is the possible erosion of trust in the system. As the Atlantic documented, local Chinese officials reported the Covid19 outbreak to the federal government weeks after it began. They also understated the extent of the disease spread, until whistle-blowers stepped forward – and were subsequently punished. This delay probably cost China valuable time in containing the initial outbreak.

This demonstrates, under a command and control ‘crisis leadership’, when people are afraid to tell the truth and discouraged from speaking up, critical information may not reach leadership, until the problem intensifies, the paper added. That said, whether the COVID19 outbreak may have been contained earlier under different leadership conditions, cannot be concluded for sure, at least, in this case. However, official data release now shows more than doubling of new Coronavirus cases to 99 in Mainland China, on April 11, 2020. Moreover, newly reported asymptomatic Coronavirus cases also nearly doubled to 63 on the same day. Hence, the fire has still not been doused. The crisis lingers.

Italy: The catastrophic impact of Covid19 in Italy, helps identify some avoidable areas in ‘crisis leadership’. With rapidly changing and inconsistent messaging, the leaders possibly created panic and distrust among people of all kinds. The top leadership seems to have underestimated the potential spread of the virus, and was not acting in coordination with various groups and stakeholders to contain it, initially.

It happened, despite Italy is a democratic country, unlike China. But, the country, apparently, did not comply with the robust and critical ‘crisis leadership’ norm of fact-based ‘participatory governance and alert public discussion’, as discussed above. This reconfirms that ‘crisis leadership’ must be very careful in saying something they will end up contradicting later, while handling, especially a social calamity, like Covid19 outbreak.

The United States: With the fire of Covid19 outbreak spreading fast in the United States, one finds again, some basics of crisis management norms were missing in the top leadership of the oldest and a robust democracy of the world. Instead, President Trump demonstrated ‘a tendency to rely heavily on his inner circle rather than subject matter experts and to state opinions as facts.’ The President also contradicted experts on his own task force attempting to educate the public, most notably by consistently overstating the scientifically acknowledged timeline to create a vaccine and the preventive medicine combo. He also questioned the reported fatality rate of the virus.

This type of ‘crisis leadership’ is likely to fail in inspiring trust and confidence with the masses, the article concluded. This is evidenced by the current status of the country. The lethal firepower of Covid19 is still hitting the United States very hard, against all its might to fight the invisible enemy garnering all its resources and possibly taking more lives than what it lost, as on date, while fighting all its wars. As on April 11, 2020, the death toll from Coronavirus in the United States eclipsed Italy’s for the highest in the world, surpassing 20,000 marks.

Now let me focus on India, with my own assessment about the ‘crisis leadership’ while responding to this crisis, of course, initially.

India:

To get a perspective of Covid19 spread in South Asia on a relative yardstick, let’s look at the following Government released figures, as quoted in the Reuters report on April 08, 2020:

Country Ind Pak Afghan Sri Lanka Bangladesh Maldives Nepal Bhutan
Cases 5274 4072 444 189 218 19 9 5
Death 149 58 14 7 20 0 0 0

On April 11, 2020, the World Bank estimated, the ‘worst economic slump in South Asia in 40 years.’ Further, India, Bangladesh, Pakistan, Afghanistan, Sri Lanka and other three smaller nations, with 1.8 billion people and thickly populated cities, although have so far reported relatively few Coronavirus cases, could be the next hotspots for Covid19.

With this, let us look at the Covid19 narrative being unfolded in India, so far. In a lighter vein, following the interesting events with ‘sound’ and ‘light’, the ‘camera’ of time has indeed captured a commendable display of high quality ‘crisis leadership’ in India. Especially, under the given circumstances prevailing at that juncture. The leadership approach fits so well into one of the most critical requirements of crisis management – ‘participatory governance and alert public discussion.’

Even, some seemingly pointless events for some, at the end of the day, did raise morale of many in the fight against Covid19 outbreak, besides their level of participation and involvement in this crisis. Whether or not it is purely due to the personal charisma of the Prime Minister and his huge followings, also doesn’t matter much, as the point is, what really happened, instead of why it happened.

Besides, right from the declaration of ‘Peoples Curfew’ of March 22, 2020 to 21-day national lockdown, the Prime Minister has involved the State Chief Ministers, but also the leaders of opposition parties. Indian Council of Medical Research (ICMR) is also visible in the forefront. The net result is the support that the Prime Minster is getting from all, despite hardship – an epitome of ‘crisis leadership,’ as on date.

Thus, the beginning has been laudable, especially when India had no option but to enforce a lockdown, in one form or the other, without having enough testing kits, Personal Protective Equipment (PPE) for healthcare manpower and required health care infrastructure for quarantine or isolation of people. Let me explain this point with a very recent example.

According to a recent report, Covid19 test guidelines presumed that most patients in India acquired the virus from their travels abroad, or from someone who travelled abroad. Accordingly, with a limited number of kits, tests were conducted to zero in on these patients, isolating and quarantining them, to curb the spread of the virus. very focused with lesser requirements of the testing kits.

However, the data compiled by ICMR from random Coronavirus tests on patients with severe respiratory diseases, indicate that 38 percent of Covid19 patients with no travel or contact history have contracted the virus. On April 10, 2020, the Government said that the testing has now been increased to 16000 from earlier 5000-6000 people per day. This raises the vital question: has Covid19 outbreak in India has progressed or progressing from stage 2 to stage 3 of the outbreak, or has the community spread of the disease begun, the last and final stage being stage 4 – the scary virtually uncontrolled Coronavirus outbreak? Alarmingly, as has been widely reported, even on April 12, 2020: ‘Coronavirus in India: Several targets missed, still no sign of rapid testing kits.’ Currently, ‘India ranks extremely low in the Coronavirus-hit countries list based on the number of tests done per million population.’

Thus, the declaration of 21-day national lockdown on March 24, 2020, at the early stage of the Coronavirus outbreak in India was an unprecedented decision. Besides, containing the rapid disease spread, it gave India a small time-space to prepare itself – with more testing kits, Personal Protective Equipment (PPE) for healthcare manpower and adequate number of high-quality – isolation, quarantine and treatment facilities, equipped the disease specific requirements, such as, ventilators.

No matter what, the decision for a 21-day nationwide complete lockdown, giving priority to life over livelihood was a tough call to take for any leader. It indeed was a part of the critical test for excellence in ‘crisis leadership,’ at that point of time.

Conclusion:

Be that as it may, as the saying goes ‘proof of the pudding is in the eating,’ the acid test for excellence in ‘crisis leadership’, obviously, will be based on the quality of outcomes and the time it will take. This will include multiple key factors, such as, the speed of health, social and economic turnaround of a country, which is sustainable. Nevertheless, the crisis is far from being over – anywhere in the world, just yet, and the jury is still out.

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.

 

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

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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.

Prior to this import ban, a report of February 17, 2020 had flagged that paracetamol prices have shot up by 40 percent in the country, while the cost of azithromycin, an antibiotic used for treating a variety of bacterial infections, has risen by 70 percent. The Chairman of Zydus Cadila also expects: “The pharma industry could face shortages in finished drug formulations starting April if supplies aren’t restored by the first week of the next month,” as the news item highlighted.

No significant drug shortages reported, just yet:

From the above details, it appears, no significant drug shortages have been reported due to Coronavirus epidemics in China – not just yet. Moreover, the Minister of Chemicals and Fertilizers has also assured: ‘No shortage of drug ingredients for next 3 months.’ He further added: ‘All initiatives are being taken to ensure there is no impact of the disease in India.’

However, on March 03, 2020, W.H.O, reportedly has warned of a global shortage and price gouging for protective equipment to fight the fast-spreading coronavirus and asked companies and governments to increase production by 40 percent as the death toll from the respiratory illness mounted. Moody’s Investors Service also predicted, coronavirus outbreak may increase demand, but poses a risk of supply chain disruptions, especially for APIs and components for medical devices sourced from China.

In view of these cautionary notes, especially the health care and regulatory authorities, should continue keeping the eye on the ball. More importantly, commensurate and prompt interventions of the Government, based on real-time drug supply-chain monitoring, along with the trend of the disease spread, will play a critical role to tide over this crisis.

In search of the ‘Magic Bullet’: 

Encouragingly, on February 16, 2020, the National Medical Products Administration of China has approved the use of Favilavir, an anti-viral drug, for the treatment for coronavirus. The drug has reportedly shown efficacy in treating the disease with minimal side effects in a clinical trial involving 70 patients. The clinical trial is being conducted in Shenzhen, Guangdong province. Formerly known as Fapilavir, Favilavir was developed by Zhejiang Hisun Pharmaceutical of China. A large number of other promising R&D initiatives are being undertaken, in tandem, by brilliant scientific minds and entities to find an effective treatment for this viral disease. To give a feel of it, let me cite just a few examples, both global and local, as below.

Pfizer Inc. has announced that it has identified certain antiviral compounds, which were already in development, with potential to treat coronavirus-affected people. The company is currently engaged in screening the compounds. It is planning to initiate clinical studies on these compounds by year-end, following any positive results expected by this month end.

Several large and small pharma/biotech are now engaged in developing a vaccine or a treatment. Gilead has, reportedly, initiated two phase III studies in February 2020, to evaluate its antiviral candidate – remdesivir, as a treatment for Covid -19. Takeda is also exploring the potential to repurpose marketed products and molecules to potentially treat COVID-19, besides developing a plasma-derived therapy for the same. Pipeline candidates of other companies are in earlier stages of development, as reported.

Whereas in India, Serum Institute of India (SIL) is collaborating with Codagenix, a US-based biopharmaceutical company, to develop a coronavirus cure using a vaccine strain similar to the original virus. The vaccine is currently in the pre-clinical testing phase, while human trials are expected to commence in the next six months. SII is expected to launch the vaccine in the market by early 2022.

Zydus Cadila, as well, has launched a fast-tracked program to develop a vaccine for the novel coronavirus, adopting a two-pronged approach, a DNA based vaccine and a live attenuated recombinant measles virus vectored vaccine to combat the virus. These initiatives seem to be a medium to long-term shots – laudable, nonetheless. 

Current off-label drug treatment for coronavirus:

Some of the drugs, reportedly, being used in China to treat coronavirus include, AbbVie’s HIV drug, Kaletra and Roche’s arthritis drug – Tocilizumab (Actemra). However, none of these drug treatments have been authorized yet by drug regulators, to treat patients with coronavirus infection.

According to the Reuters report of March 04, 2020, China’s the National Health Commission, in its latest version of online treatment guidelines, has indicated Roche’s Tocilizumab for coronavirus patients who show serious lung damage and elevated level of a protein called Interleukin 6, which could indicate inflammation or immunological diseases.

However, there is no clinical trial evidence just yet that the drug will be effective on coronavirus patients and it has also not received approval from China’s National Medical Product Administration for use in coronavirus infections. Nonetheless, Chinese researchers recently registered a 3-month clinical trial for Actemra on 188 coronavirus patients. According to China’s clinical trials registration database, the period of trial is shown from February 10 to May 10. 

Is coronavirus becoming a community transmitted infection?

Even while grappling with an increasing number of COVID-19 positive patients, the Indian Government is showing a brave front, as it should. However, it has also confirmed “some cases of community transmission.” This unwelcome trend makes India the part of a small group of countries, including China, Japan, Italy and South Korea, where community transmission of the virus has taken place. This is a cause of an additional concern.

Although, there has been no significant drug shortages reported yet, shortages of  hand sanitizers,recommended for frequent use by the W.H.O and other competent bodies, as they can, reportedly kill Covid-19. Similarly, N95 masks useful to prevent the spread of the disease, have also disappeared, adding more fuel to fire, if not creating a panic-like situation, for many.

Conclusion:

Most global drug players with a business focus on branded – patented drugs, are not expected to fight with the supply disruptions. As reported, ‘Several top drugmakers – including Pfizer, Johnson & Johnson, Bayer, Merck KGaA and Roche—recently confirmed to FiercePharma that they have stock policies in place to minimize the impact.”

But, for the generic drug industry the disruption in the supply chain may have a snowballing effect. For example, as the March 03, 2020 edition of the New York Times (NYT) reported – supply chain disruption in sourcing some APIs from China is being felt most acutely in India, as the Government decided to stop exporting 26 drugs, most of them antibiotics, without explicit government permission. The same article also highlighted the possible multiplier effect of this development with its observation: “That’s a problem for the rest of the world, which relies on India’s drug makers for much of its supply of generic drugs. India exported about $19 billions of drugs last year and accounted for about one-fifth of the world’s exports of generics by volume”, it added.

As on date, there is no known cure for coronavirus infection. The magic-bullet has yet to be found out. However, over 80 clinical trials has, reportedly, been launched to test coronavirus treatments. This includes, repurposing older drugs, as well. Recently, only Favilavir, an anti-viral drug, has been approved for treatment for coronavirus by the National Medical Products Administration of China.

Coming back to the unease of many in India, the country’s perennial shortages of doctors, paramedical staff, hospital beds, adequate quarantine facility for a large number of patients and fragile public healthcare delivery system, still pose a humongous challenge in this crisis. More so, when just in the last week, U.S. intelligence sources, reportedly, told Reuters that ‘India’s available countermeasures and the potential for the virus to spread its dense population was a focus of serious concern.’

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.