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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.

Hepatitis C: A Silent, Deadly Disease: Treatment Beyond Reach of Most Indians

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Every year, July 28 is remembered as the ‘World Hepatitis Day’. In India, this year too, the day had gone by virtually uneventful, for various reasons. This happened despite increasing trend of the disease in the country.

Though, there are five main hepatitis virus types, namely A, B, C, D and E, of which B and C are the most fatal, in this article, I shall focus mainly on hepatitis C.

According to the World Health Organization (WHO), globally around 150 million people are infected with chronic hepatitis C virus (HCV), which is considered as one of the key factors for liver cirrhosis, fibrosis and hepatocellular carcinoma. At least, 350,000 HCV infected people die annually from these ailments.

A July 2014 study conducted by Metropolis Healthcare reportedly found that 17.97 percent of 78,102 samples studied in major cities of India such as, Mumbai, Delhi and Chennai, were infected with HCV and the patients belonged to the age group of 20 to 30 years. Out of 10,534 the tested sample in the age group of 0 to 10 years, 3,254 samples (30.89 percent) tested positive with HCV.

Institutes of Medicine (IOM) and the Department of Health and Human Services (HHS) of the United States consider hepatitis C infections a “silent epidemic,” as many patients infected with HCV are symptom free, without even leaving any hint to them that they are infected. The infected persons may feel healthy, even when serious liver damage is taking place, sometimes through decades.

All these patients are also potential carriers of HCV, risking rapid spread of the virus, as identification of the infected individuals for remedial measures continue to remain mostly eluding in India.

According to experts, around 80 percent of the HCV patients ultimately develop chronic hepatitis with serious liver damage, causing significant debility. With further progression of the disease, around 20 percent of these patients could develop fatal liver cirrhosis and 5 percent may fall victim of liver cancer.

A situation like this, is indeed a cause of yet another major worry in the healthcare space of India. Deadly hepatitis C crisis would likely to worsen much, if it does not receive healthcare focus of all stakeholders, sooner.

Traditional treatment regime:

There is no vaccine developed for HCV, as yet. HCV usually spreads through sharing of needles, syringes or other equipment to inject drugs, infected blood transfusion and tattooing, among others.

The standard treatment for HCV is interferon-based injections, which could make patients feel ill and give rise to flulike symptoms. Moreover, the treatment with interferon lasts from six months to a year and cures only 40 to 50 of HCV infected patients.

Now, chronic HCV treatment also includes a combination of three drugs – ribavirin (RBV), pegylated interferon (PEG) and a protease inhibitor, such as, simeprevir or boceprevir or telaprevir. These three drug combinations inhibit viral replication for enhancing immune response of the body to hopefully eradicate the virus.

At times, patients with very advanced liver disease may not be able to tolerate this traditional treatment with interferon-based injections, as those could make them feel worse.

The latest development in treatment:

There has been a significant advance in the treatment of HCV patients today with a new drug in the form of tablet that has doubled the viral cure rates from 40 to 50 percent to 90 to 100 percent.

Moreover, the new drug not just enables the physicians switching from injectibles to oral tablet, but at the same time reduces the duration of treatment to just 12 weeks, instead of 6 months to one year, offering a huge advantage to patients suffering from HCV.

This new generation of treatment now includes only Sovaldi (sofosbuvir) of Gilead, which is the first drug approved to treat certain types of hepatitis C infection, without any compelling need to co-administer with interferon.

Some other global pharma majors, such as Bristol-Myers Squibb, Merck & Co, Johnson & Johnson and AbbVie are also developing oral treatment regimens for HCV. All these have shown equally dramatic results in clinical trials, reducing the requirement for debilitating interferon injections.

Allegation of profiteering:

Looking at the high cure rate of more than 90 per cent for much-distressed HCV infected patients, none would possibly dispute that Sovaldi of Gilead signifies a giant leap in the treatment of HCV. But Gilead, according to a ‘Financial Times (FT)’ report, faces strong criticism of alleged ‘profiteering’ for its pricing strategy of this drug.

Sovaldi has been priced by Gilead at Rs 60,000 (US$ 1,000) per tablet with a three-month course costing Rs1.8 Crore (US$ 84,000), when it reportedly costs around U$130 to manufacture a tablet. This treatment cost is being considered very high for many Americans and Europeans too.

“At the US price, Gilead will recoup its Sovaldi development investment  . . . in a single year and then stand to make extraordinary profits off the backs of US consumers, who will subsidize the drug for other patients around the globe”, the FT report states.

This line of argument has been gaining ground on Capitol Hill, as well. This month, two senior members of the US Senate Finance Committee wrote to John Martin, Gilead Chief Executive, asking him to justify Sovaldi’s price, the report mentioned.

Half yearly sales of US$ 5.8 billion came from just 9,000 patients:

Be that as it may, the bottom line is, in the midst of huge global concerns over alleged ‘profiteering’ with this exorbitantly priced HCV drug, Gilead has reportedly registered US$ 5.8 billion in sales for Sovaldi in the first half of 2014.

The company has reportedly noted on its earnings call that it believes 9,000 people have been cured of HCV so far with Sovaldi. This means that the 6-month turnover of Sovaldi of US$ 5.8 billion has come just from 9000 patients. If we take the total number of HCV infected patients at 150 million globally, this new drug has benefited just a minuscule fraction of less than one percent of the total number of patients, despite clocking mind-boggling turnover and profit.

Stakeholders’ pressure building up:

Coming under intense pressure from all possible corners, Gilead has reportedly announced that it has set a minimum threshold price of US$ 300 a bottle, enough for a month. With three months typically required for a full course and taking into account the currently approved combination with interferon, the total cost per patient would be about US$ 900 for a complete treatment against its usual price of US$ 84,000. The company would offer that price to at least 80 countries.

For this special price, Gilead reportedly has targeted mostly the world’s poorest nations, but also included some middle income ones such as Egypt, which has by far the highest prevalence of HCV in the world. In Egypt, about 10 million people remain chronically infected and 100,000 new infections occur each year, according to Egyptian government figures. However, independent surveys  put this number between 200,000 and 300,000. Gilead has already signed an agreement with the Egyptian government in early July 2014 and the drug would be available there in September 2014. This would make Egypt the first to have access to Sovaldi outside the US and the EU.

What about India?

Gilead has reportedly announced, “In line with the company’s past approach to its HIV medicines, the company will also offer to license production of this new drug to a number of rival low-cost Indian generic drug companies. They will be offered manufacturing knowhow and allowed to source and competitively price the product at whatever level they choose.”

This is indeed a welcoming news for the country and needs to be encouraged for expeditious implementation with support and co-operation from all concerned.

Regulatory requirement:

However, despite all good intent, Gilead says, “ Some countries, such as India and China, are not satisfied with the tests conducted in the US and elsewhere for Sovaldi. They want additional clinical trials to be conducted on their own patients as a precondition for authorization, which will add extra costs and delays.”

Patent status:

It is worth noting here that the Indian patent office has not even recognized Sovaldi’s patent for the domestic market.

Local measures to address chronic hepatitis:

On May 22, 2014, the World Health Assembly adopted a resolution to improve prevention, diagnosis and treatment of viral hepatitis, in general. However, as things stand today in India, the surveillance systems for viral hepatitis are grossly inadequate and preventive measures are not universally implemented.

The Union Government of India has now expressed its intent to set up ten regional laboratories through the National Communicable Disease Centre (NCDC) for surveillance of viral hepatitis in the country. The key objective of these laboratories would be to ascertain the burden of viral hepatitis in India by 2017 and to provide lab support for investigating outbreaks.

Government sources indicate, the initial focus would be more on the preventive aspects rather than treatment of viral hepatitis given the limited health resources available. Setting up universal guidelines for immunization along with mass awareness and education have been considered as critical to fight this dreaded disease in the country. Simultaneously introduction of nucleic acid testing (NAT) and standardization of blood bank practices would be undertaken for preventing blood transfusions related viral hepatitis, in general.

Treatment for HCV is not widely available in the country. All types of HCV treatments, especially the newer and innovative ones, must be made available to all infected patients, as these drugs have high cure rates, short duration of treatment and minimal side effects.

Conclusion:

Viral hepatitis in general and hepatitis C in particular are becoming great national health concerns, as these contribute to significant morbidity and mortality, further adding to the national economic burden. India should just not strengthen its prevention strategies; it needs to focus on all the factors that influence speedy diagnosis and treatment of HCV.

As the WHO says, “New drugs have the potential to transform hepatitis C treatment, with safe and simple treatments resulting in cure rates of over 90 per cent”. The raging debate on Sovaldi needs to explore the newer avenues and measures for appropriately pricing the innovative medicines in the days ahead.

Concerned pharma players, the government and other stakeholders must work together and in unison to ensure that all those infected with HCV are diagnosed quickly and have access to life-saving treatments.

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.