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Cacophony Over Coronavirus Lockdown

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

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

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

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

The Government’s rationale behind 3 weeks lockdown:

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

  • The incubation period of Covid19 is around 5 to 14 days. This is also the potential transmission period of the microbe. Effective social distancing of all, may contain or even stop its spread.
  • As all viruses can sustain or exist only by replicating, they are completely dependent on a host cell for survival and can’t reproduce outside a cell. Social distancing may help in this area, as well.
  • Since, the world doesn’t have any vaccine for Covid19, as yet, prevention alternatives are limited.

Cacophony includes: Is complete national lockdown the only answer?

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

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

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

Are our doctors adequately protected against Covid19?

Today, even the doctors and other health care workers remain extremely vulnerable to the disease.  Even in AIIMS doctors, reportedly, are using masks and sanitizers made by themselves or buying them. There is already a shortage of Personal Protective Equipment (PPE), which doctors are worried about. PPE includes face masks, eye shield, shoe cover, gown and gloves. These can be used for only five or six hours before having to discard them. Even N-95 face masks cannot be used for more than a day or two. And there is an elaborate protocol in place, as well, on how to dispose them. As the report said, doctors fighting Covid19 asked: ‘Not just claps, give us personal protective gear.’

Further, the Huffpost article of March 20, 2020 had emphasized with details: “Staying home can be hard, but it’s not even an option for the health care workers and scientists on the front lines of our global effort to thwart the COVID-19 pandemic. They have to arm themselves to face potentially infected patients and deadly viruses every day.” This gets vindicated by a March 26, 2020 report. It brought to our notice that 900 people have been quarantined after a Delhi Doctor unprotected by PPE tests COVID19 positive.

Another news article reported: “A day after the entire nation flocked to their balconies to clap for the heroes in the medical field, who are working relentlessly to arrest the Coronavirus pandemic, doctors in Telangana and Andhra Pradesh were greeted with humiliation and assault.”

Cacophony expands to religious solutions and explanations:

With the panic on Coronavirus spreading, the cacophony also includes religious solutions to the disease. For example, as reported by Reuters on March 14, 2020, ‘Hindu group offers cow urine in a bid to ward off Coronavirus.’ Another YouTube video also shows: ‘Hindu activists in India drink cow urine to ‘protect’ themselves from Coronavirus.’ According to many there are many takers of such concepts, whether one likes it or not.

Intriguingly, a top film star with 40.7 million twitter followers twitted on March 22, justifying public clapping at 5 pm during ‘Janata curfew’ and attributing a bizarre reason to it: ‘clapping vibrations destroy virus potency,’ which he later deleted against strong adverse comment from the scientific community. However, a number of, apparently responsible people, a few of whom are also known to me, often comment – such things can happen and do happen in a vast country like India. It isn’t a big deal. The cacophony goes on.

Be that as it may, regardless of enthusiastic public clapping and availability of cow-urine based solutions – fighting deadly Covid19 of potentially infected patients – without PPE, I reckon, is quite akin to asking a professional army to fight a tough battle without having adequate battle-gear.

Level of India’s preparedness just before national lockdown:

To ascertain this, leaving aside other critical areas, such as, quarantine and isolation facilities, let me cite a few examples related to PPE and testing kits. A news that came just a day before the national lockdown, reported a Government official commenting on a textile material used for masks and other PPEs: “Currently, demand is for 8 lakh bodysuits and N95 masks of the material. Orders for these have been placed.”

However, the Directorate General of Foreign Trade (DGFT), reportedly, banned the export of textile material for masks and coveralls, under the Foreign Trade (Development) and Regulation Act, just recently. Interestingly, as Reuters reported on March 28, 2020, ‘India needs at least 38 million masks and 6.2 million pieces of personal protective equipment as it confronts the spread of Coronavirus.”

Further, when testing is the only acid test to diagnose Covide19 infection – as on March 19, 2020, India, reportedly, had tested 14,175 people in 72 state-run labs, which is regarded as one of the lowest testing rates in the world. This is because: India has limited testing facilities. Thus, only those people who have been in touch with an infected person or those who have travelled to high-risk countries, or health workers managing patients with severe respiratory disease and developing Covid-19 symptoms are eligible for testing. Whereas, according to W.H.O, “All countries should be able to test all suspected cases, they cannot fight this pandemic blindfolded”.

However, after declaration of the national lockdown, the Indian Council of Medical Research (ICMR) on March 25, 2020, reportedly, invited quotations from manufacturers for supply of 1 million kits to test patients suspected of suffering from COVID-19. After getting a glimpse of the cacophony over the national lockdown for Coronavirus supported by a few examples, let us see what steps the W.H.O advises for all countries to follow in this pandemic. 

The steps W.H.O recommends following:

On March 16, 2020, the Director General (DG) of the World Health Organization (W.H.O) said: “We have a simple message to all countries – test, test, test.” On that day, observing that more cases and deaths have been reported in the rest of the world than in China, as compared to the past week, the DG elaborated the following:

  • Although, there has been a rapid escalation in social distancing measures, like closing schools and cancelling sporting events and other gatherings, but, not an urgent enough escalation in testing, isolation and contact tracing – which is the backbone of the response.
  • Social distancing measures can help reduce transmission and enable health systems to cope with. Handwashing and coughing into your elbow can also reduce the risk for yourself and others. But on their own, they are not enough to extinguish this pandemic. It’s the combination that makes the difference. Thus, all countries must take a comprehensive approach.
  • The most effective way to prevent infections and save lives is breaking the chains of transmission. And to do that, you must test and isolate. You cannot fight a fire blindfolded. And we cannot stop this pandemic if we don’t know who is infected. We have a simple message for all countries: test, test, test. Test every suspected case.
  • If they test positive, isolate them and find out who they have been in close contact with up to 2 days before they developed symptoms, and test those people too. Every day, more tests are being produced to meet the global demand.

Curiously, even three months after the massive outbreak of the Coronavirus epidemic in China, India doesn’t seem to have procured enough PPEs for the doctors and testing kits to diagnose the disease. Besides, lack of advance preparation to create adequate quarantine and isolation facilities in the country make the situation even more complex to effectively deal with.

Other challenges and frugal options:

With eight doctors per 10,000 people in India, compared to 41 in Italy and 71 in Korea and one state-run hospital for more than 55,000 people, the general population has developed a much avoidable habit, over a period of time. It is quite likely, even in the event of getting flu-like symptoms, the majority may not go to doctors. Instead, may try home remedies or go to a retail chemist for drugs. Some may even resort to self-medication, until a full-blown disease surfaces, complicating the situation further.

Hence, only two options are left. One – for each individual to take care of personal hygiene and physical distancing, and second – for the Government to announce a national lockdown, through its second sudden and late evening order, effective midnight of the same day. This took almost everybody by surprise and possibly creating a widespread panic – not so much about the disease – at least initially, but more for regular availability of essential daily necessities – food and for many people – medicines, besides means for daily living of scores of families. This was further fueled by the gross lack of empathy by the law enforcers.

Conclusion:

As reported, if Covid19 continues to spread at its current pace, India could face between around 100,000 and 1.3 million confirmed cases of the disease caused by the new Coronavirus by mid-May, according to a team of scientists based mainly in the United States. It’s important to note that with just 6.8 tests per million, one of the lowest rates in the world, India has been criticized for not testing enough.

Moreover, besides panic and economic fallout of the disease, the long-term impact that Covid19 may have on the mental health of different people, for various reasons, will also need to be ascertained. As Professor Vikram Patel of Harvard Medical School said in his above article, ‘the deliverable is not how many people clanged pots and pans’ or how many obediently followed the Prime Minister’s advice of staying indoors. “The deliverable is how many people got tested, how many doctors have protective gear, how many ventilators the government managed to manufacture or buy overnight.” Another deliverable is isolation centers, temporary hospitals in indoor stadia and quarantine facilities that are fit for human beings, he added.

On November 24, 2020 – when 21-day national lockdown commenced, the total number of confirmed cases in the country were reported as 564. Just at the beginning of the 5th day of the lockdown on March 29, 2020, as I write this piece, as many as 1032 people have been tested positive for Covid19 with 28 deaths. Against the above backdrop, some critical points that surfaced while exploring the cacophony over the national lockdown, can possibly be wished away only at one’s own peril.

Nevertheless, under the prevailing circumstances, there was no other alternative for the Government, but to announce immediate national lockdown, which all should abide by, religiously. However, whether Coronavirus will be won in India with 21-day of national lockdown – just three days more of what the Mahabharata war took, as the Prime Minister expects, will start revealing from April 15, 20120 – as the moment of truth arrives.

By: Tapan J. Ray  

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

 

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

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

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

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

The impact assessment has commenced:

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

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

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

The current status:

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

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

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

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

No significant drug shortages reported, just yet:

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

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

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

In search of the ‘Magic Bullet’: 

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

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

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

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

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

Current off-label drug treatment for coronavirus:

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

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

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

Is coronavirus becoming a community transmitted infection?

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

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

Conclusion:

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

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

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

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

By: Tapan J. Ray 

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