Misjudged remedy: What is unworkable is made to work !

Medicines which are approved for treatment of Covid-19 did not complete clinical trials for their efficacy. Not even one of them was originally developed to target Covid-19. Some of the medicines were withdrawn after the approval. By the time, large drug makers could make their fortunes better. Their stock prices shot through the roof and made their investors richer at the peril of sick people. When the story of traditional medicines’ successful contribution in the fight against the infection and saving life of many people were heard loudly some players wanted Ayush to stay demoted. 

Judges are not doctors. They are neither expected to be so nor do they ever claim to be doctors. Doctors can be judges of a patient's health, but can never be the judges to deliver justice to public issues. Let judges do their honorable job and doctors theirs. Our constitution may become more beautiful, if everyone does only what is mandated to do.

We know, judges are not lawmakers, but an authority to make judgment based on prudence of what lawmakers may have put in place. A public interest litigation (PIL) filed in March 2020 sought the Court direction to the State government to include all Ayush treatment in accordance with the Ayush Ministry notification in the fight against the pandemic. The Kerala High court passed a judgment on 27th August, 2020. In the judgment it said: "If any qualified doctor practicing AYUSH medicine, makes any advertisement or prescribes any drugs or medicines, as a cure for COVID-19 disease, except those specifically mentioned in Annexure-I advisory to Exhibit-P1 D.O. letter dated 6.3.2020, it is open for the respondents to take appropriate action under the provisions of the Disaster Management Act, 2005, and the orders of the governments, both Central as well as the State, issued from time-to-time”. It further said: “Only those tablets or mixtures shall be given as immunity booster and not as a cure for COVID-19.” AYUSH medical practitioners were ordered not to violate the Government Order dated 6.3.2020.”

Of course, the government can caution doctors not to prescribe any fake medicine advertised through the media or sold through company representatives. Of course, there are systems in place which can control false publicity of medicines. Wrong advertisements are curtailed by dedicated codes under Advertising Standards Council of India (ASCI). No drug can be sold in the market for unintended or uncertified purposes under a tight regime. If a qualified doctor finds any medicine that is useful for certain illness and sees himself working well safely, can there be any law to prohibit doctors from prescribing it? I admit that the pandemic is a different situation. WHO has set a standard treatment protocol for the entire world. Most countries are supposed to go by it. Unfortunately, there is no targeted medicine for treatment of Covid-19.

People who are very vocal and specialized in filing PIL never file where there is an urgency. If a medicine is not approved for treatment, no doctor is expected to prescribe the same. He identifies immunity medicine as immunity medicine and curative as curative with no room for confusion. Medicines are not usually advertised, but hospitals used to do that. As a product, advertisement of medicine through the media is not necessary since the same is bought by people against doctors’ prescription. Doctors are the targets of every medicine advertisement. That target can be met without advertising through mass media. However, there is another avenue called the news hype, which is more powerful and impactful than display advertisements. Sadly, there is no rule to curtail it. Covid-19 saw many drug companies launching medicines for treatment of Covid-19, though none of them was developed for that target. There were medicines, which were approved and sold out before the approval was withdrawn. Sadly, none wanted to file any PIL against the action. 

Thank God, the judgment was only on what the petitioner sought for, with a calibrated interest.  While the honorable Court went by what the government had dictated in the name of protocol, it seemed to have overlooked the individual freedom to seek treatment for disease, according to their choice and trust.

There are reports of Ayurveda playing a great role in fighting against the pandemic. I have seen many individuals who have been seeking only Ayurvedic treatment for Covid-19 in Maharashtra. They have chosen a line of treatment they trusted for their disease. They may have their own reasons for the choice. Neither they nor I have ever heard any patient under Ayurvedic treatment died of wrong medicine. Many people who have been severely and multiple infected could find relief through Ayurvedic medicines.

A patient has his or her own freedom to choose a treatment for illness. The government cannot compel a patient to go only to a place where the government dictates.

Each individual is more cautious about his or her own health than the government is. First of all the government directed medical protocol disallowing treatment of Covid-19 by none other than the government is senseless these days when the infection is spreading like a wildfire. It is not the government, which will treat any disease, but collectively the medical fraternity.

I see the judgment is plain and revalidation of what the government wants, but not what the public at large wants. Here the role of the Court was not necessary, but the regulators and bureaucracy were enough. A qualified medical practitioner is not supposed to prescribe medicines which are unapproved by government authorities. Immunity boosters are approved medicines as a preventive solution. If a qualified medical practitioner feels that particular immunity booster can also treat the disease, what is wrong with prescribing the same even after infection?

Indeed, the government can issue codes of conduct but can never ask doctors not to deliver treatment to a patient who seeks their help with a medicine that doctors believe suitable. By setting a rigid protocol in the context of no targeted medicine available for the treatment of the pandemic, the more influential drug makers grab a huge stake in the market of pandemic treatment. That is what we have seen since March this year. Drug Controller General of India (DCGI) approved medicines one after the other since the pandemic began to be aggressive. But in all these drug cases patients’ recovery depended rather on their luck than on the quality of the medicine. 

While giving the approval the regulator also knew none of the medicines was proven to treat the Coronavirus disease. Those medicines were not even tested for retargeting the Covid-19 indications. The medicines were said to be used in emergency or as an off-label dosage to control the pandemic. Many of these medicines were either unsafe or unworkable in several cases.

Let’s see how some of the approvals worked. Hydroxychloroquine and lopinavir (ritonavir), which was one of the first to rock the Covid-19 market, was found to be unworkable soon after granting the approval. Weren’t clinical scientists then aware of the medicines indications? Hydroxychloroquine makers had become richer overnight. The solidarity trial promoted by WHO and its partners found hydroxychloroquine delivering no benefit of treatment. Other trials also found the same result. Almost three months after the active use of hydroxychloroquine and lopinavir, WHO accepted Solidarity Trial’s International Steering Committee's recommendation to discontinue the trials. In fact, hydroxychloroquine was said to have side effects of severe heart arrhythmia. All the countries, including India withdrew the approval. By the time, several containers had moved around the world and the manufacturers built their fortune.

Another medicine favipiravir, an oral antiviral drug, fast-tracked by DCGI did not have approval in the US and European Union. The medicine was launched with a big fanfare in India. In the first week of July 2020, DCGI approved remdesivir, which was originally developed for targeting Ebola, for treatment of Covid-19. The efficacy of the drug for the treatment was not proven when the drug was given Emergency Use Authorisation. Drug companies sold it for a song. Patients now search for the medicine in the grey market, which is made in India under license from a US company, Gilead Hetero. Soon, DCGI also approved tocilizumab, an immunosuppressive injectable drug developed for targeting rheumatoid arthritis and systemic juvenile idiopathic arthritis. The medicine was manufactured by the global drug giant Roche Pharmaceuticals. This prohibitively high cost medicine was said to render higher risk of bacterial infections. Sadly, this medicine, known as rich men’s vials, sold through premium brand hospitals. Some “dealers” became richer as this costly medicine was sold for premium. Another high cost itolizumab, which was used for treating psoriasis was also given Emergency Use Authorisation before the final clinical trial report was out. The National Task Force on Covid-19 later decided against this medicine.

Drug companies’ stock prices had shot through the roof. None of the medicine could reduce mortality. The drug induced post recovery sickness would be huge as many people reported serious health discomfort. They look for an immunity booster, which prevents infection.  

When Covid-19 continued to roar, a British clinical trial found that the steroid called dexamethasone could work on reducing mortality. Though it was prescribed for late-stage patients of ventilator cases, it also had post-recovery risks like stomach upset, headache, dizziness, menstrual changes, trouble sleeping, increased appetite, or weight gain.

When the number of infections soared, the government wanted doctors to use medicines they feel fit for the patient. But those who were keen to hold on their forte wanted to see traditional medicines remaining where it was, despite their excellent performance. Huge volume of research papers, too many expert opinions and confusion of local governing bodies in managing rapidly rising cases made the pandemic management move off the track. As people resort to traditional ways of treatment as a self defence, they remain safe in terms of health and wealth. When several cases were treated by traditional medicines and reduced caseload, cartels did not want people to trust the traditional medicines.

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