Monthly Archives: August 2020

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

Posted on by
Reply

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

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

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

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

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

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

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

Perils of haste in the Hydroxychloroquine saga:

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

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

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

Soon, India followed the same… a strange coincidence?

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

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

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

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

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

Its rub-off financial impact in India:

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

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

Perils of haste in the plasma therapy saga:

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

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

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

Conclusion:

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

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

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

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

By: Tapan J. Ray  

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

Covid-19 Vaccines – A Multifaceted Perspective

Posted on by
Reply

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

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

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

Vaccines may not be ‘silver bullets’ for all:

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

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

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

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

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

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

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

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

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

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

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

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

One in three Americans appears reluctant to be vaccinated:

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

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

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

But how broad is this ‘spectrum of doubt’?

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

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

Is there any anti-vaccination movement in India?

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

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

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

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

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

Other challenges for mass vaccinations in India:

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

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

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

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

Conclusion:

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

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

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

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

By: Tapan J. Ray  

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

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

Posted on by
Reply

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

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

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

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

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

The paradox: 

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

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

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

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

Impact on demographic dividend:

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

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

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

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

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

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

Name of Vaccine

Number of years to develop

Varicella

28

FluMist

28

Human papillomavirus

15

Rotavirus

15

Pediatric combination

11

Covid-19 goal

18 months

Some countries promised even sooner:

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

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

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

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

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

Conclusion:

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

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

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

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

By: Tapan J. Ray 

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

 

 

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

Posted on by
Reply

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

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

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

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

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

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

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

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

The current treatment approach and the pharma focus:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Conclusion:

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

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

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

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

By: Tapan J. Ray 

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

 

New Digital Tools To Protect From Infection, Neutralize Covid-19

Posted on by
Reply

There seems to be some light at the end of the dark tunnel of a serious biological threat that the world is passing through, since the nightmarish last seven months. The COVID-19 pandemic has spread to 213 countries and territories, and the number of new cases is continuously rising. According to reports, the severity of the situation has already re-shaped our society, more than ever before.

In tandem, reports are arriving from most countries, testifying the tremendous commitment of the governmental, scientific and clinical communities, to help local populations dealing with the pandemic. Scientists are still far from having a complete picture of the pathophysiology of this dangerous disease, including its long-term implications on individuals.

Amid this challenge, round the clock search for a life-saving and long-term pathway to outmatch the fast-spreading Covid-19, seems to be coming to fruition, soon. If everything materializes as expected, Covid-19 vaccines may be available by the end of this year or at the beginning of the next year. If it happens, this will be a record in the history of any vaccine development process, as the normal ‘mind to market’ period to deliver a scientifically proven, safe and effective vaccine is normally around 10 years. That said, there always exists a gap between the cup and the lip, as the saying goes.

No doubt, vaccines will be the best way to bring the new Coronavirus under a tight leash to help normalize life, restore livelihoods, and putting a nation’s economy back to the growth trajectory. The good news is, alongside this magic bullet, the power of technology is exploring other technological measures to keep the virus at bay, wherever possible. In this article, I shall focus on this interesting area.

Let me hasten to add, the value offerings of these devices can’t be compared with the long-term benefits that vaccines will offer in containing this global pandemic. Nevertheless, the questions still remain, when will a well-documented, safe, effective and affordable vaccine hit the market?

W.H.O expects to deliver 2 billion doses of vaccines by end 2021:

According to a News Release of July 15, 2020, by the World Trade Organization (W.H.O): ‘Seventy-five countries have submitted expressions of interest to protect their populations and those of other nations through joining the COVAX Facility, which aims to:

  • Accelerate the development and manufacture of COVID-19 vaccines.
  • Guarantee fair and equitable access for every country in the world.

The goal of COVAX is to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO pre-qualification, by the end of 2021. Besides W.H.O, other experts are also cautiously optimistic about the availability of Coronavirus vaccines ‘soon’. Here also the question may crop up: how soon is ‘soon’?

How soon is ‘soon’ – for sooner availability of Covid-19 vaccines?

Experts have opined, a vaccine would normally take years, if not decades, to develop. However, in this unprecedented global health crisis, researchers hope to achieve the same amount of work in only a few months, following the ‘fast track’ regulatory pathway. Let me give a sense of the prevailing buzz around the availability of some of these vaccines.

Going by what the Chief Executive Officer (CEO) of Serum Institute of India said about Oxford-AstraZeneca developed vaccine, many expect their availability by the end of the current year in India. The Company CEO, reportedly, said on July 22, 2020: “By November, we hope to launch the vaccine if the trials are positive and if the Drug Controller of India blesses it and says it is safe and effective.”

Further, on July 28, 2020, Moderna Inc. and Pfizer Inc. also launched two 30,000-subject trials of Covid-19 vaccines that could clear the way for regulatory approval and widespread use by the end of this year, as the companies announced. Notably, both vaccine candidates rely on a new technology that allows for faster development and manufacturing than traditional vaccine production methods, but does not have an extensive track record.

According to another report of July 30, 2020, Russia said, the world’s first COVID19 vaccine to be ready by August 12, 2020. The vaccine is being developed by Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology.

India’s indigenous experimental Coronavirus covid19 vaccine candidate, developed by Bharat Biotech, is also undergoing phase 1 and Phase 2 trials at 12 sites spanning across India. The initial results are positive. Earlier, ICMR had announced its launch on August 15, 2020. However, specialists in this area feel, ‘the August 15 timeline seems totally unrealistic, if not entirely impossible.’

Be that as it may, most experts still think a vaccine is likely to become widely available by mid-2021, about 12-18 months after the new virus, known officially as Sars-CoV-2, first emerged. Bringing to the market a Covid-19 vaccine, no doubt, will be considered as a ‘huge scientific feat,’ but ‘there are no guarantees it will work’ for all. It’s also a point to ponder that ‘Coronaviruses already circulate in human beings. They cause common cold symptoms and we don’t have vaccines for any of them’ just yet, as the report highlights.

It’s, therefore, a clear possibility that a well-documented, safe and effective Covid-19 vaccine may not be available, at least, in the next 6 months. Moreover, access to an affordable Coronavirus vaccine by the global population will also not happen in a jiffy. In that case, it is encouraging to note that other cutting-edge technological initiatives are also moving ahead with a great speed, to bring the rapid transmission of the new Coronavirus under a tight leash.

Novel, non-medical tech initiatives to contain the Covid-19 spread:

As potentially lethal Covid-19 is overwhelming the world, besides search for new drugs, faster diagnosis to fight the infection – and most effective preventive measure – vaccines, several non-medical tech initiatives are also underway. Many of these are quietly heading forward in search of user-friendly solutions, not just to ‘take the pressure off overworked health care workers’, but also ‘to stop the spread of the disease.’ These are all running parallel to offer technology driven disease treatment-options during this global health crisis.

An interesting paper from the European Parliamentary Research Sevice (EPRS), also vindicates some critical developments in this area. It focuses on technology-based solutions for various pressing pandemic-related problems. Let me illustrate this point with one example each, in the areas of ‘taking the pressure off overworked health care workers’, and in ‘stopping the spread of the disease.’

Technology to ‘take the pressure off overworked health care workers’:

Even in India, one hears quite a lot about the hardship of overworked health care workers. Various unconventional ways were also prescribed for the nation to encourage them. Some of these aren’t inexpensive, either. From this perspective, one such application is robotics technology. It can be effectively used as an intelligent solution to reduce the risk of person-to-person transmission − especially in pandemic hotspots. As the above EPRS article highlighted, many countries are now deploying robots in other areas also to ‘take the pressure off overworked health care workers,’ such as:

  • To disinfect whole hospitals,
  • Decontaminate public and private sites,
  • Handle biohazardous waste,
  • Deliver food and medication to infected patients,
  • Taking patients ‘ temperatures and act as medical assistants.

For example, an Israeli-made AI-powered robot assistant is, reportedly, being used in hundreds of hospitals, medical centers, nursing homes, and corporate buildings in Asia. This is to help minimize human-to-human contact as millions of people take precautions due to the novel Coronavirus outbreak worldwide. By the way, Israel is now a good friend of India, too.

Technology ‘to stop the spread of the disease’:

On June 01, 2020, Science Daily reported, the researchers at Penn State, the University of Minnesota and two Japanese universities, have found that a personal, handheld device emitting high-intensity ultraviolet light to disinfect areas by killing the novel Coronavirus, is now feasible.

Another report of July 10, 2020 also brought to the fore that the researchers from the University of Houston have created a new air filter that virus tests at the Galveston National Laboratory found can kill 99.8 percent of COVID-19 instantly. The filter could be useful for killing COVID-19 in public places, such as, in airports and airplanes, in office buildings, schools and cruise ships, besides other closed spaces such as schools, hospitals and health care facilities. Thus, the ability of this “catch and kill” air filter to control the spread of the virus could be very useful for society,” confirmed another report.

On July 29, 2020, an Indian business news daily wrote, ‘Bengaluru-based Organization De Scalene has received clearance from the US Food and Drug Administration (USFDA) and the European Union to license and manufacture Scalene Hypercharge Corona Canon (Shycocan).’ The device disables the virus’ capability to infect, by flooding electrons in closed areas. It is claimed that Shycocan ‘has the ability to neutralize 99.9% of the Coronavirus that might be floating in the air in closed spaces.’

Although, it is not an alternative to medicines that can cure infected people or preventive vaccines, the device can be used to keep Covid-19 at bay, at least, till vaccines arrive. Thus, going by these developments, one gets a sense of various non-medical technological activities post Covid-19 pandemic outbreak. Especially about, how today’s technological whiz kids are working alongside the medical scientists to take the sting out of Covid-19 onslaught.

Conclusion:

The Lancet article – ‘Applications of digital technology in COVID-19 pandemic planning and response,’ published on June 29, 2020, also made similar observations. It said: ‘With high transmissibility and no effective vaccine or therapy, COVID-19 is now a global pandemic.’ In this scenario, to contain the spread of a highly transmissible virus, countries that have quickly deployed digital technologies in various critical areas to contain the spread of the infection, may emerge as front-runners in managing disease burden, the paper concluded.

As of August 02, 2020 morning, the recorded Coronavirus cases in India reached a staggering 1,751,919 with 37,403 deaths. Recent Sero-surveys also show COVID-19 peaks in the country is still far away. It is very likely that a vast majority of the population will survive the Covid-19 catastrophe, even if only the existing systems are followed. But, just surviving is neither the reason nor the purpose of life. What most people want today is finding out a comprehensive way for – ‘jaan bhi and jahan bhi’ (life also, the world also).

Understandably, on July 31, 2020, W.H.O has also reiterated: “The pandemic is a once-in-a-century health crisis, the effects of which will be felt for decades to come.” Under this backdrop, unleashing the potential of new non-medical digital tools, as illustrated above, seem to be of immense benefit – not just to protect many more people from the infection, but also to neutralize Covid-19 effectively, especially in 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.