COVID Crisis: Be Scientific,  Convalescence Is No Answer

 COVID 2

It is well known that Covid pandemic is caused by a novel virus (SARS-CoV-2), Its variants and mutated forms which did not exist earlier. It is natural not to have drugs that would prevent or eradicate this new virus! But if lakhs of people are getting infected, and suffering to the tune of thousands of deaths, the medical profession would not sit silently with hands crossed. Until scientific research determines the accurate therapies and therapeutic approaches, physicians will try to treat and find a cure for a new disease, by using drugs available, based on their experience of dealing with germs that are closely related to the pathogens of the disease in consideration.

In the process, scientists and physicians apply a variety of medications to study what treatment is effectively combating this new condition. This search goes on in multiple centres. All these experiences are analysed and a new approach is determined by making appropriate changes to the medication and confirming the appropriate dosage. The World Health Organization reviews these experiences from around the world and releases guidelines from time to time.  In our country the ICMR, the Drug Controller of India, and the Union Ministry of Health determine such recommendations. And all the doctors in the country follow these instructions and implement them and provide treatments. The guide lines, of course, are not statutory or mandatory but are followed in general as a precept.

Some of the many drugs being investigated in this order may fail.  Some drugs may not be hopeful initially, but become handy later. It may also turn out that some of the drugs that worked very well earlier are proved later ‘not as useful’.  In our country Organizations like I.C.M.R. should coordinate this sequence from time to time and make the most scientific suggestions. It is the responsibility of not just the scientists but also the government officials and political leaders alike to direct them. Is such scrupulous scrutiny followed regularly in our country?

Certain guidelines and recommendations are released by AIIMS,  ICMR-COVID-19 National Task force/joint monitoring group and Ministry of health and Family welfare, on 22nd  April. Some revised guidelines were issued by Ministry of health on 28 th April. The present guidelines are said to be in supersession to guidelines issued on 2nd july2020 on the subject of home isolation of mild cases. Let us see them in conjunction.

The first recommendations were made in March 2020. That was a time when there was very limited experience and information about the covid disease. After more than a year’s experience, the second set of recommendations are pronounced but they seem to be shallow. ICMR recommends some drugs that have been rejected and discarded as useless in many parts of the world.

The management experience gained throughout the world in this miserable year does not seem to be fully codified in guidelines. Over a year, doctors throughout India have followed central instructions and their experience has shown that some of the medications they prescribe are not so useful. Drugs such as chloroquine, ivermectin, and Fabi flu have shown some positive results in the past, but after extensive use they have been shown to be less effective. However, some of them are still finding place in our government recommendations. This means that doctors have to use drugs which they know are of no use.

Perhaps during the intervening period (September 2020 to March 2021) from the first boom to this second wave, no one cared to collect and analyse the data properly. The Prime Minister’s political statements in a theatrical style even from international platforms- “We conquered corona, -” seem to have been literally accepted by scientists and academics alike.

In spite of repeated intimations and cautions from the scientific committees and sectors regarding the possibility of a drastic condition of a more violent second wave of covid, not even a minimum protocol of preventive actions was framed or thought off. More over everything was let loose in the name of rejuvenation of economy, “atma nirbhar bharat”, and such other high pitch slogans were chanted. Self-glorifying programmes and a very complacent attitude studded with anti-scientific approaches were at the helm. The so-called decision-making duo of the government did not spare a second to prevent the forth coming tsunami. It was arrogance and carelessness towards people that prevented sensible action. The same attitude echoed in bureaucracy and people are made to believe that all is well.

Lack of readiness and lack of development of infrastructure in the interim period has led to almost a collapse of the system to combat the tsunami-like second outbreak of the covid 19. This left the country in the same or even more miserable plight of inability to face it. But all blame is shifted conveniently on to the people, for not wearing masks and not maintaining social distance.

I am yet to understand how people follow certain directions when the highest offices are not following. In addition, many politicians engaged and promoted huge conglomerations of people for political and religious purposes. From Panchayats to state offices multiple level elections for a protracted period were conducted. The focus from covid is shifted to elections and whole administration is after that so called “democratic process” without giving an iota of care to lives of the people and no precautions taken to prevent the viral spread.

It is no wonder if someone calculates that the spread of covid cases has increased by 530% in the election held states. When a minister (Assam) himself says there is no need of wearing masks, why to blame people? When prime minister expresses his great satisfaction and happiness on a big gathering of masses in an election meeting, whom to condemn for not maintaining social distance? When all parties promote rallies and processions for the sake of “democratic elections” what else can be done except a court coining election commission as culprit fit to be hanged.

They say virus will not spread from Kumbh mela even if lakhs of people gather there due to sanctity of Ganges. I still fail to understand why scores of akhadas died after the sacred mela and thousands of cases appeared in all corners of India, once the pilgrims returned to their places.

What did we learn from one year of living together with the corona virus? When we direct and adopt such an attitude in social events, how much scientific care is extended in health care is any body’s guess. Did any scientific advisory body open its mouth and fix the responsibility genuinely?

It is doubtful whether the old precepts were released in a hurry with new dates and not really updating the guidelines. After 11 January 2021, the scientific task force on covid 19, the Supreme Committee of India, which makes these decisions, did not meet, despite the increase in cases in February and March. They met on April 15 and released the guidelines on the 22nd. Hence the suspicion whether due care was taken in making scientific recommendations. Let’s look at some examples.

Methodically patients are divided into three categories mild, moderate and severe grades of the disease depending on clinical symptomatology. Well, this is acceptable but the lines and divisions are indistinct and there is scope for wrong grading and the whole treatment regime changes accordingly.

Rightly stress is given for home quarantine, in mild cases. But as a physician I observed if one person is isolated in the house, within a very short time all other members of the family, mainly the elder parents and neighbours are sure to become positive patients. Simple reason being that the houses are so small and crowded that real isolation (in a separate room) in most houses is a myth. Social centres for isolation should have been recommended.

Those in the home quarantine and negative but contacts in the same house are advised to use tab. Chloroquine (Hcqs) to prevent infection. Many countries have stopped using this drug. European countries have banned the use of HCQS in Covid disease on the grounds that it may aggravate some heart diseases.

Most of us remember how Hcqs was aggressively promoted in USA initially by the then President Trump. Then Indian government audaciously declared it will supply the drug to the whole world. It is to be noted that 70% of worlds chloroquine production is from India. HCQ is an anti -malarial, malaria is prevalent in India but not in the developed countries. So other countries won’t produce it. The production was increased and saw a false rally in stock prices.

In spite of the populist and hurried statement by the president the US FDA has not approved chloroquine. Later it was declared useless in USA. Hence the exports fell down sharply. We did not stop it and the Indian government has distributed about 10 crore chloroquine tablets till January2021, in the name of curbing the virus, which is of no real value. But it serves two purposes, one to gain some reputation that government is doing service to fight against virus, (which is not a weapon at all ! )  and secondly benefitting the pharma companies like cadila, Ipca and Torrent etc., to clear their pent-up stocks. They hiked the prices from 9 to 16% in this period.

The country has a monthly production capacity of 40 tons of HCQ. Indian government ordered for 10 crore tabs in the peak demand season and purchased them even after knowing that HCQ has no significant role in preventing or treating Covid. The drug after initial promotion was stopped for some time in India also. Again, this drug is recommended as ‘therapy based on low certainty of evidence’. It is now distributed in the free kits given to positive patients during home quarantine. For whose benefit is it being practised?

Also, ivermectin, a drug that is used as anti-parasite. It was claimed to reduce viral load in the early stages, its use gave mixed results and most countries removed it from recommendations. It is also observed by many Indian physicians that it has no effect on reducing the severity of the disease. This drug is now recommended in early stages and also as a measure to prevent infection. It is recommended though without much significant evidence as “may use” or may not use category. when the highest scientific body cannot decide whether to prescribe it or not, how can a practising clinician decide? Now the proponents and individual institutes produce data, not so authentic, to highlight the positive effect of drug.

Let’s take a look at the most commonly used drug in the past called favipiravir (fabiflu). The drug was approved in Japan in 2014 to prevent the flu. It was then identified as a very harmless drug. The corona is also similar to the flu, so the drug is tried for Covid as well, but its dose had to be increased. For Flu it was 1200 mg dose. For covid it is increased up to 3600 mg on the first day. In these trials and experiments it worked better than drugs like Lopinavir and Ritonavir. It reduced the virus load in vitro(lab). But in the actual treatment the expected result was not achieved. Glenmark pharmaceuticals launched this in june2020, with much hype, as the first Covid-19 antiviral drug from India.

Now ICMR, AIIMS have removed it from their list. However, it is such a popular drug that patients buy and use it on their own. So even doctors are writing it out profusely.

A similar remedy is injection Remdesivir. In May 2020, the USFDA approved the drug for emergency use in the United States. It was then recommended as a priority medication for those on oxygen in the ICUs, as patients are on the verge of death. But experience showed this has had many side effects. In particular, the liver, blood clotting system, and many other enzymes in the digestive system need to be checked regularly if the drug be administered. So, India permitted, Remdesivir for severely ill patients.

It is to be noted that India mostly follows the American foot steps and very rarely takes into consideration the experiences of UK or EU and almost never from China or East Asian countries. The fruitful rich experience of China in combating Covid can be adopted by India but it is not considered as a source.

Gilead sciences co., produces this medicine and in june2020 they were hopeful of supplying to 20 lakh patients by the end of the year.  They confidently estimated that by end of 2021 they would do a business of about 200 to 300 crore dollars. Seven pharmaceutical giants in India like cadila, cipla, Dr Reddy labs and Hetereo etc, are in to this product. A 100mg vial was fixed between Rs3000toRs.4500.

The World Health Organization (WHO) has stated that the drug ‘does not need to be used’ at any stage of the disease, regardless of the severity. The drug did not reduce the severity of the disease or the number of deaths. It is a very expensive drug, has to be administered through intravenous route, under medical supervision. The workload on nursing staff will increase much and is difficult to follow in this pandemic condition. So, there are limitations to the use of this drug and its low efficacy in advanced stage is established. (Study by Siemieniuk RC, Bartoszko JJ)

Almost all studies have shown that the drug may be given within 5 to 10 days of exposure to the virus at a moderate level, with a slight drop in oxygen level, but there is no benefit afterwards.

But it is so popular in our country that people believe that the remedy is Brahmastra to Corona. This was promoted so by vested interests. They view it as the life-giving Sanjeevani. Some doctors are sceptical that it is not.

Some doctors and hospitals are pushing that drug and people are prepared to buy it on the black market for lakhs of rupees instead of an average MRP of Rs 3000. All the manufactures of Remdesivir slashed prices two months ago on the request of government.one company was supplying at Rs.899 only.

Today the black supply chain is well organised from a corporate hospital to a small nursing home in semiurban areas, everywhere you get the drug, the question is only about the price. This artificial scarcity is mainly due to holding it for monitory benefits. If the business perspective is removed and the drug is used solely on the basis of its scientific indication no shortage or no hike in price occurs.

The guidelines now given correctly state that this drug should be used in limited cases with a limited purpose. But in practice almost everyone who goes to the hospital (regardless of whether it is a private or public hospital) is prescribed this injection.

We should look into the issue of transfusion of convalescent plasma. During first wave phase, it was promoted as the most advanced and most definitive treatment. Voluntary organizations, associations and government agencies have organized promotional programs to roll in plasma donors, organized camps for plasma donation. The donors, obviously who came out of the brunt of covid safely and successfully were treated as heroes and publicized as nobles saving life of unfortunate patients.

But later it was learnt that the result of this treatment was also not as fruitful as expected. it is said that plasma treatment should not be given unnecessary importance as it is of some use at a time when the viral load is low and in some vulnerable patients who do not have enough immunity.

ICMR by 17-11-2020, based on its multicentric study concluded that convalescent plasma therapy was of some use if given within 7-8 days of infection of the virus, but later it was not useful. This means that plasma is of no use when the patient is admitted to the ICU and is kept on ventilator support. Therefore, this recommendation has been pushed to the bottom in the new guidelines.

It is true that family members are pushing for plasma if the patient’s condition is deteriorating. This is due to misconception created by medical profession and media’s bogus promotion. Some treatment centers are also making unnecessary haste for plasma to show that they have made all efforts, such as expensive medicines and plasma transfusion etc.

It MUST be stressed that inj. Remdesivir, Tocilizumab and convalescent plasma are mentioned for off label use. Based on limited available evidence and only in SPECIFIC conditions, clearly defined but all the three have become mainstay treatment in all corporate hospitals.

Technically the transfused plasma should have high titers of anti- bodies to be of any help to recipient. But in an emergency situation where attendants are pressurized to secure plasma, some plasma is secured even without checking for anti- bodies, being purchased at exorbitant prices. If family members cannot secure the required quantity of plasma, medicines or injections like remdesivir, they are engulfed by a feeling of guilt and helplessness that haunt them lifelong, and feel dejected. This messy, commercial angle results in loss of trust, loss of credibility and loss of confidence on health care institutions.

This mistrust is doubled as covid patients are kept isolated and no attendants are allowed. Patients undergo depression and anxiety, seek lot of attention and are not easily satisfied with the present state of care by an inefficient and incompetent system with poor infrastructure.

The CMO of a corporate hospital in Hyderabad, and head Association of corporate hospitals of TS, summarizes the situation by revealing how patients through influential persons, political leaders and friends of the hospital administrators directly or by phone calls try to force them to arrange for the rich plasma, high flow oxygen, instead of nonbreathing face mask, NIV oxygen or ventilator etc, even if not needed. They prefer remdesivir to methylprednisolone and low molecular heparin. Patient’s attendants feel safe and secure if they are arranged beforehand. This is an inevitable result of the situation of shortage of medicines and materials versus increasing number of patients requiring them. This is the result of havoc and psychological pressure created in society due to mishandling of pandemic, deficiencies in service and institutional inadequacies.

However, in the guidelines given by ICMR, there is no ban on the use of medicines that have not been proved to be useful.   Not even a warning was included against their use. Some medicines are used because there are suggestions in guidelines that they can be used under the head “Not Must, but may be Used” category.  Moreover, a patient is given a variety of drugs (multiple drugs) at the same time for various reasons. The doses of steroids and route of administration are also followed as per the will and wish of the physician not necessarily on base of evidence. The useful drugs are misused in early or in extended indications causing some harm rather than benefit to patient. Added to this, various systems of medicine are suggesting various tricks and tips. Some of them are proved detrimental but there is no control about this either.

Due to the lack of publicity about removing some medicines which were prescribed in past, they are still used. Drugs such as doxycycline, azithromycin, flavipiravir, itolizumab (monoclonal antibody used in anti- cancer treatment and approved for covid initially) etc. are being used. These names are not mentioned in today’s suggestions, but due to the publicity from the beginning, and marketing strategies. nearly 80% of doctors use them extensively. It is not known how far they are useful for corona patients.

Be Scientific in approach

It should be noted that unnecessary medication can cause harm. It is worth recalling Dr.B.M.Hegde, former vice chancellor of Manipal University  who emphasizes that ‘for every ill there is no pill, but for every pill there is an ill, sometimes it may kill.” Let us see how greed of pharmaceutical companies, create a magic of markets and resort to deplorable methods like blatant lies in the name of scientific research and the governing persons act as hand and glove. During the process scientific cover is used to fool the public.

On February 19, Yoga guru Ramdev released a research paper by Patanjali Ayurved on what he claimed was the “first evidence-based medicine” -coronil- for the coronavirus at an event that was attended by Union ministers Harsh Vardhan and Nitin Gadkari. The yoga guru claimed that both the central government and the World Health Organization had given a green signal to the medicine. He claimed the drug was WHO GMP certified, meaning it holds a certificate of pharmaceutical product and is recognised by the World Health Organisation’s Good Manufacturing Practices (NDTV.)

“Patanjali has made history in the field of Ayurveda as Coronil has been recognized by WHO as First Evidence Based Medicine for Corona, Several Bharatiya Janata Party leaders also backed Patanjali’s claim. BJP spokesperson described it as “no less [than] a huge endorsement for Ayurveda and India’s homegrown start up ecosystem that has flourished under the Modi government”.

But the World Health Organization soon clarified that it had not reviewed or certified the effectiveness of any traditional medicine. The Indian medical association questioned the health minister “how justified is it to release such falsely fabricated unscientific product to people of the whole country and how ethical was it to promote the product in unethical, wrong and false ways,” IMA National President Jayalal urged. “Let us not adulterate Ayurveda on the pretext of market gain to some monopoly corporate and create a disaster for humanity.”

This is just one example of how things are managed for the sake of market advantages and proves beyond doubt that everything that is circulated as scientific recommendation is neither scientific nor genuine. This is true with all big business houses involved with covid management either medicine or medical products. Market management with the help of highest governing and controlling bodies and profit driven policies are resorted to at the cost of science.

The furore over vaccination is yet another example of how trade takes upper hand over science. Though every sensible person agrees to the need of introduction of vaccines as early as possible, science cannot be sacrificed for the sake of emergency. The astonishing   rapidity with which the vaccines were brought out throughout the world casted doubts on their efficacy. India is not away from this mad rat race condensing all scientific studies and shortening study periods.

Who introduces the vaccine first? became an issue of pseudo national pride. It is considered as a chance of seizing the market rather than triumph of science. Naturally It created such doubts on the effectiveness and safety of vaccines that In India even the frontline warriors of covid were hesitant to accept the vaccination. The adverse comments and marketing tactics one on the name of international standards and another on the name of “true national developed vaccine with local studies” added to the confusion. The role of government in supporting one against the other, and also acting as mediator, makes it clear the role of political sponsorship.

If you enjoy that sponsorship. You can alter any rule to your advantage. The covishield vaccine is scheduled to be given in two doses with a gap of 28 days and was followed like that initially, then the company recommended to increase the interval to 45 days, and now the company quotes a study which says efficacy increases to 85% if the interval is 90 days. The covid working group endorses it and recommends 12 to 16 weeks interval between two doses. Do these frequent changes indicate true science or altered to suit the production capacity and stock position of vaccine in the market.

It is well known that the production capacity of SII-Covishield is between 5-6crore doses and Bharat biotech -covaccine is 1.6 crore doses per month. No other company was allowed to produce vaccine and no import arrangements were made. The Sputhnik-V, vaccine however is available with Dr.Reddy labs but still waiting for clearances to be marketed. Now arrangements are made to ramp up monthly production of covishield to 10 crore doses and covaccine to 7.8 crore doses by the end of August. Few other vaccines may be available after 3 or 4 months.    But still government takes pride in announcing as the largest vaccination programme in the world being conducted rapidly. Not even 13 crore doses are administered, the programme reached a stage of stagnation due to the shortage of supplies.  But still our empty assurances will not stop and day after day new sections of people, now up to 18 yrs age are included for vaccination. The two companies are allowed to enhance their production capacity the results if any will be seen 2 months later. Can we call it the world class leadership of combating covid pandemic?

If all the known medicines are not useful, what else should be done?

The disease should be recognized as of viral origin. It should be known that there is no drug as of now that kills the virus and treatment is given for symptoms and effects on organs like lungs and heart.  In the first phase (week), medicines should be used to reduce cough, cold and fever. If you enter the second week, use medicines to arrest replication of virus, steroid inhalations and oxygen to improve lung function. If the condition is too serious, steroid injections and anti- coagulants should be used judiciously to prevent blood clots and ease the blood supply. Ventilator help may be required.

At all stages, immune-boosting, vitamin fortified food and pranayama, which improves respiration, are required. People who are covid positive, and those negative but symptomatic, should be in isolation for at least three weeks under medical surveillance. Above all, the virus should be prevented with the trident of wearing masks, maintaining the cleanliness of surroundings and bodies, and maintaining physical distance. Wear a shield called vaccination.

The solution should be to prevent the disease rather than worrying about treatment. It is not impossible to prevent the disease if you give up panic and take appropriate precautions. If exposed to the disease, you should be treated at home. Strong mental morale and positive attitude are of paramount importance to boost your immunity rather than multiple drugs put together. Careful monitoring especially of oxygen level, fever, respiratory rate and blood pressure must be strictly followed. All comorbid conditions be attended with due care. Any change should not be ignored, but health care taker be informed and on his/her advice, should go to the hospital quickly and get special services, advices and treatments. Since the death rate from this disease still restricted to1or2 per cent, the fear of corona disease being deadly should not be entertained. It be fought en masse with a focus on prevention.

It may not be out of place to share that I am an orthopaedic surgeon but ever since the virus took charge of the world I have been following the scientific and social  proceedings. I am on free online consultation and telemedicine and treated hundreds of patients with home quarantine, very few of them requiring hospital admissions, I don’t hesitate to mention that in the second wave of the progression of disease is faster and more younger people are in need of hospital admissions in comparison to the first wave cases.

It is also observed that some patients in hospitals’ monitoring and apparently in good vital status face sudden death with cardiac arrest.  Such facts are not given due importance in the new guidelines. I emphasize that fear and apprehension are the principal factors that shake majority of patients rather than hypoxia or cytokine storm. Too much information and misinformation are leading to anxiety and apprehension rather than inculcating knowledge and confidence in them.

We should use our resources fairly and treat the collapsed medical system in a way that does not burden us unnecessarily. It is not impossible to get out of this chaos if the rulers act responsible and show empathy, recognizing the fact that half a million people are becoming sick daily. At least for now, stop speeches, plan and execute. People are dying.

I conclude by quoting Dr.Gangakhedkar, the Ex ICMR scientist who speaks against irrational and non-scientific  treatments. He advised “The government should clearly communicate with doctors and hospitals to stop or rationalize the ongoing use of convalescent plasma and antiviral drug remdesivir” and cautioned that We could become a breeding ground for several mutants…if we do not adhere to evidence-based treatments.

Dr. S. Jatin Kumar is an orthopaedic surgeon


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