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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.

Pharma Innovation Absolutely Critical: But NOT Shorn from Ethics, Propriety, Compliance and Values

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Significant value added innovation is the bedrock of progress of the pharmaceutical industry and is essential for the patients. This is a hard fact.

However, this current buzzword – ‘innovation’ can in no way be shorn from soft business necessities like, ethics, propriety, compliance and values… not just for longer term sustainability of business, but more in the larger interest of patients and patient groups.

Most importantly, ‘ethics, propriety, compliance and values’ are not meant for mere display  in the corporate websites like, any other business showpieces. These should neither be leveraged to create a false positive impression in the minds of the stakeholders with frequent PR blitzkriegs.

The creators of these soft ‘X factors’ are now being increasingly hauled up for gross violations of the same by the Governments in various parts of the world .These are not just legal issues. The net impact of all such acts goes much beyond.

In this article, I shall deliberate on these continuing and annoying issues both in global and local perspectives, quoting relevant examples at random.

The sole purpose of my argument is to drive home that all such repeated gross violations, as reported in the media, go against patients’ interests, directly or indirectly. None of these incidents, in any way, can be negated with stories of great innovations or with any other make of craftily designed shields.

Under increasing scrutiny in the developed world:

Ethics, propriety and business value standards of big pharma, besides various types of legal compliance, are coming under increasing stakeholders’ scrutiny, especially in the developed markets of the world.

Very frequently media reports from across the world, highlight serous indictments of the Government and even judiciary for bribery, corrupt business practices and other unbecoming conduct, aimed at the the global mascot for healthcare.

It is indeed flabbergasting to note that more and more corporates, with all guns blazing at the same time, publicize with equal zest various initiatives being taken by them to uphold high ethical standards and business practices, if not propriety, as the juggernaut keeps on moving forward, unabated.

The scope of ‘ethics and propriety’:

The scope of ‘ethical business conducts, propriety and value standards’ of a company usually encompasses the following, among many others:

  • The employees, suppliers, customers and other stakeholders
  • Caring for the society and environment
  • Fiduciary responsibilities
  • Business and marketing practices
  • R&D activities, including clinical trials
  • Corporate Governance
  • Corporate espionage

That said, such scope should not be restricted to the top management, but must be allowed to percolate downwards in a structured manner, looking beyond the legal and regulatory boundaries.

Statistics of compliance to ‘codes of business ethics and corporate values’ are important to know, but the qualitative change in the ethics and value standards of an organization should always be the most important goal to drive any corporation and the pharmaceutical sector is no exception.

‘Business Ethics and Values’ in the globalized economy:

Globalization of business makes the process of formulating the ‘codes of ethics and values’ indeed very challenging for many organizations in many ways. This is mainly because, the cultural differences at times create a conflict on ethics and values involving different countries.

For this purpose, many business organizations prefer to interact with the cultural and religious leaders in the foreign countries, mainly to ascertain what really drives culturally diverse people to act in certain ways.

With the wealth of knowledge of the local customs and people, the cultural and religious leaders can help an organization to unify the code of ethics and values of the globalized business.

Such leaders can also help identifying the ‘common meeting ground of minds’ from a specific country perspective, after carefully assessing the cultural differences, which are difficult to resolve in the near term.

The ‘common meeting ground of minds’ within a given society, thus worked out, could form the bedrock to initiate further steps to strengthen global business standards of ethics and values of an organization.

OECD with USA started early enacting ‘Foreign Corrupt Practices Act (FCPA)’: 

To prevent bribery and corrupt practices, especially in a foreign land, in 1997, along with 33 other countries belonging to the ‘Organization for Economic Co-operation and Development (OECD)’, the United States Congress enacted a law against the bribery of foreign officials, which is known as ‘Foreign Corrupt Practices Act (FCPA)’.

This Act marked the early beginnings of ethical compliance program in the United States and disallows the US companies from paying, offering to pay or authorizing to pay money or anything of value either directly or through third parties or middlemen. FCPA currently has significant impact on the way American companies are required to run their business, especially in the foreign land.

A dichotomy exists with ‘Grease Payment’:

OECD classified ‘Grease payment’ as “facilitating one, if it is paid to government employees to speed up an administrative process where the outcome is already pre-determined.”

In the FCPA of the US, ‘Grease Payment’, has been defined as “a payment to a foreign official, political party or party official for ‘routine governmental action,’ such as processing papers, issuing permits, and other actions of an official, in order to expedite performance of duties of non-discretionary nature, i.e., which they are already bound to perform. The payment is not intended to influence the outcome of the official’s action, only its timing.”

Many observers opine, ‘Grease Payments’ is an absolute dichotomy to the overall US policy for ethical standards and against corruption.

Currently besides US, only Canada, Australia, New Zealand and South Korea are the countries that permit ‘Grease payments’.

Notwithstanding, the governments of the US and four other countries allow companies to keep doing business without undue delay by making ‘Grease Payments’ to the lower government officials, such payments are considered illegal in most other countries, in which they are paid, including India.

In India such a business practice is viewed as bribery, which is not only perceived as unethical and immoral, but also a criminal offense under the law of the land. Even otherwise, right or wrong, ‘Grease Payments’ are viewed by a vast majority of the population as a morally questionable standard of ‘business conduct’.

Many companies are setting-up the ethical business standards globally:

While visiting the website of especially the large global and local companies, one finds that all these companies, barring a very few exceptions, have already put in place a comprehensive ‘code of business ethics and values’. Some of these companies have also put in place dedicated code compliance officers across the globe.

‘Practice as you preach’:

Despite all these commendable initiatives towards establishing corporate codes of business ethics and values, the moot question that keeps haunting many times and again: “Do all these companies ‘practice what they preach’ in real life?”

Instances are too many for breach in ethics, propriety and value standards:

The media is now increasingly reporting such instances of violations both locally and globally.

Some Indian examples: (At random, not in a chronological order)

Criminal drug regulatory manipulation:

One of India’s top pharma players reportedly will pay a record fine of US$ 500 million in the US for lying to officials and selling badly made generic drugs.

The company has pleaded guilty to improper manufacturing, storing and testing of drugs, closing a year long civil and criminal investigation into the matter.

Compensation for deaths related to Clinical Trials not paid:

In 2011 the Drug Controller General of India (DCGI) reportedly summoned nine pharma companies on June 6 to question them on the amount of compensation they have decided to pay the ‘victims of their clinical trials’, which is a mandatory part of any clinical trial, or else all other trials of these nine companies going on at that time or yet to start, will not be allowed.

Clinical Trial is another area of pharmaceutical business, especially in the Indian context, where more often than not, issues related to ethics and values are being raised. In an article titled, ‘Clinical trials in India: ethical concerns’ published by the World Health Organization (WHO) following observations have been made:

“The latest developments in India reflect a concerted effort on the part of the global public health community to push clinical trials issues to the fore in the wake of several high-profile cases in which pharmaceutical companies were shown to be withholding information from regulators.”

Alleged marketing malpractices:

In 2010, the Parliamentary Standing committee on Health reportedly expressed concern that the “evil practice” of inducement of doctors by the pharma players continues.

Congress MP Jyoti Mirdha sent a bunch of photocopies of air tickets to Prime Minister Manmohan Singh to claim that doctors and their families were ‘beating the scorching Indian summer’ with a trip to England and Scotland, courtesy a pharmaceutical company.

30 family members of 11 doctors from all over the country reportedly enjoyed the hospitality of the concerned company.

Department of Pharmaceuticals reportedly roped in the Revenue Department under Finance Ministry to work out methods to link the money trail to offending companies.

Some global examples: (At random, not in a chronological order)

United States Government sues a Swiss pharma major for alleged multi-million dollar kickbacks:

The United States Government very recently reportedly announced its second civil fraud lawsuit against a Swiss drug major accusing the company of paying multimillion-dollar kickbacks to doctors in exchange for prescribing its drugs.

Fraud fines: 

Two largest drug makers of the world reportedly paid US$ 8 billion in fraud fines for repeatedly defrauding Medicare and Medicaid in the USA over the past decade.

Denigrating generics:

Another global pharma major reportedly has been recently fined US$ 52.8 million for denigrating generic copies.

Drug overcharging: 

Another global drug major reportedly stirred an ethics scandal and paid US$ 499 million towards overcharging the US government for medicines.

Bribing doctors:

  • A top global pharma player reportedly paid total US$ 60.2 million to settle a federal investigation on alleged bribing overseas doctors and other health officials to prescribe medicines. 
  • Another European pharma group reportedly was fined US$ 3bn after admitting bribing doctors and encouraging the prescription of unsuitable antidepressants to children.

 Concealment of important facts:

A judge in USA reportedly ordered a large pharma company to pay more than $1.2 billion in fines after a jury found that the company had minimized or concealed the dangers associated with an antipsychotic drug.

Off-label marketing:

  • A Swiss pharma major reportedly agreed to pay US$ 422.5 million to resolve an investigation into alleged off-label promotion of a drug, as well as civil allegations relating to five other products.
  • The U.S. Justice Department reportedly hit an American drug major with a US$ 322 million penalty for illegally promoting a drug before it received approval by the Food and Drug Administration for that condition.

Other illegal marketing practices:

Yet another European pharma group was reportedly fined USD 34 million by a court in the United States for illegal marketing practices for its medicine.

‘Illegal’ Clinical Trials: 

It was revealed on May 17, 2013 that global pharmaceutical companies reportedly paid millions of pounds to former communist East Germany to use more that 50,000 patients in state-run hospitals as unwitting guinea pigs for drug tests in which several people died.

All these are some random examples of alleged malpractices associated with ‘ethics, propriety, compliance and values’ in the pharma world, both local and global.

Middle and lower management becomes the ‘fall guy’: 

It is interesting to note that whenever, such incidents take place, the fingers are usually pointed towards the middle or lower management cadre of the corporations concerned for violations and non-compliance.

Corporate or top management ownership of such seemingly deplorable incidents still remains confined within a ‘black box’ and probably a distant reality.

Public perception is not encouraging:

In the pharmaceutical sector all over the world, many business practices have still remained very contentious, despite many well-publicized attempts of self-regulation by the industry. The flow of complaints for alleged unethical business practices have not slowed down either, across the world, even after so many years of self-regulation, penalty and severe indictments.

Government apathy in India:

Nearer home, the Government apathy, despite being pressured by the respective Parliamentary Committees and sometimes including judiciary in repose to Public Interest Litigations (PIL), has indeed been appalling, thus far.

The Department of Pharmaceuticals of the Government of India has already circulated a draft ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ for stakeholders to comment on it. The final UCPMP, when it comes into force, if not implemented by the pharmaceutical players in its ‘letter and spirit’, may attract government’s ire in form of strong doses of regulatory measures. However, the moot question remains, will the UCPMP come at all?

Similar issues are there in drug regulatory areas falling under the Ministry of Health, especially in the clinical trial area. In this matter, very fortunately Supreme Court has intervened against a Public Interest Litigation (PIL). Thus, one can expect to witness some tangible steps being taken in this area, sooner than later.

Walking the talk:

The need to formulate and more importantly effectively implement ‘Codes of Business Ethics & Values’ should gain increasing relevance in the globalized business environment, including in India.

It appears from the media reports, many companies across the world are increasingly resorting to ‘unethical behavior, impropriety and business malpractices’ due to intense pressure for business performance, as demanded primarily by the stock markets.

There is no global consensus, as yet, on what is ethically and morally acceptable ‘Business Ethics and Values’ across the world. However, even if these are implemented in a country-specific way, the most challenging obstacle to overcome by the corporates would still remain ‘walking the talk’ and owning responsibility at the top.

Conclusion:

Pharmaceutical innovation will continue to remain the launch pad for the industry growth in the battle against diseases of all types, forms and severity. However, that alone should in no way deserve to receive encouragement from any corner shorn from Ethics, Propriety, Compliance and Values.

Balancing pharmaceutical innovation with Ethics, Propriety, Compliance and Values, I reckon, will in turn help striking a right balance, to a considerable extent, between pharmaceutical innovation and public health interest for everyones’ satisfaction, mostly the patients.

Being equipped with the wherewithal to bring new drugs for the global population and being the fundamental source of growth momentum for the generic drug industry of the world, the innovator companies are expected to lead by setting examples in this area too. After all, as the saying goes:

“Caesar’s wife ought to be above suspicion. ‥Caesar himself ought to be so too”.

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.