'Only trial and error'
Dr Ketan Vagholkar, professor of surgery, DY Patil Medical College echoed similar concerns and said, "Different patients present a wide variety of symptoms. Therefore, it is difficult to ascribe a particular drug to treat COVID-19. Scientists are also finding it difficult to develop a vaccine, in view of its biological nature. A variety of drugs are being used in different parts of the world, with varied results. A trial and error approach, is the only way to use various drugs, which may or may not be of much use in curing the patients."

However different centres may have achieved positive results, with a select few drugs, as a result, these centres are propagating the use of these drugs, which may not be useful for other population groups. Effectively all the said drugs which are in use, are acting to reduce the severity of the disease, and not offering any cure, said Dr Vagholkar. "There is a high probability that the results of studies from different parts of the world may perhaps be guided by monetary benefits. Therefore, the authenticity of articles published is highly debatable," said Dr Vagholkar.

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Dr Shaikh on why the drugs stated above could not be termed as 'wonder drugs' explained, "Remdesivir is an anti-viral drug which failed in the trial for the Ebola virus. In a trial conducted on 1,000 COVID-19 patients who were given Remdesivir by the National Institute of Allergy and Infectious diseases in USA, two months ago, there was no significant clinical benefit. But the average hospitalisation of COVID positive cases came down from 15 days to 12 days, if Remdesivir was given. The mortality rate from COVID came down from 11 per cent to 8 per cent when Remdesivir was administered. So this cannot be termed as a magic bullet. The side effects of Remdesivir include increase in liver enzyme resulting in jaundice, drop in blood pressure, cardiac arrest and then death."

Dr Shaikh also said that there is no evidence for Favipiravir resulting in benefits to COVID patients. This drug also has side effects such an increase in liver enzyme leading to jaundice as well as increased in uric acid levels which could result in gout (painful arthritis).

Dr Shaikh also commented on Ivermectin, Tocilizumab and plasma therapy. He said Ivermectin is an anti-parasite drug. It had been found that this drug requires 10 times its usual dosage to inhibit the COVID-19 virus in the laboratory, and this dose is toxic to human beings. It could result in serious side effects like muscle pain, rash, swelling of hands, feet and ankles. "The Bangladesh result, which has been quoted in favour of a combination of Ivermectin and Doxycyline, has never been published as a study in any medical journal, which means there is no clinical research to support this claim in treating COVID-19," said Dr Shaikh.

COVID-19 can lead to a condition called cytokine storm (IL-6). In this condition, the patient has an elevated level of a cytokine (a group of proteins) called IL-6, which lead to fever followed by damage to body tissues, heart, lungs and kidneys. Tocilizumab is now being used by the Brihanmumbai Municipal Corporation (BMC) in treating select patients at KEM, Nair, Sion, Seven Hills etc. "It seems to be working on select patients with IL-6 problem, but not as anti-COVID," said Dr Shaikh.

Plasma therapy debatable
While trials on plasma therapy for COVID-19 continue, one set of medical experts feels that it can work wonders with a supportive line of treatment, while the other set opines that it is too premature to make such claims without thorough clinical evidence. Plasma therapy means giving antibodies from a cured COVID-19 patient to one still suffering from it. This is not within the principle of immunology.

Dr Asha Kishore, medical director, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, said, "While there have been a few reports of convalescent plasma therapy being effective in treating COVID patients, unless there is a clinical study it is premature to consider it as an accepted form of treatment. It should be considered experimental therapy and should be monitored and regulated by the health ministry. Even data from China is too limited to confirm successful experiment of plasma therapy."

Dr Ajay Chaughule, a senior cardio thoracic surgeon, expressed similar concerns, and said, "The state government has recently announced the setting up of the world's biggest plasma bank in Mumbai, without realising the efficacy of the therapy, which is still under trial, and without realising the humongous waste of life-saving plasmas, if the trial fails. This has irked the medical fraternity in Mumbai."

'Follow guidelines'
When asked whether doctors should treat new diseases like COVID-19 symptomatically instead of waiting for clinical trials conducted or commissioned by national regulatory agencies to be completed, Dr Subhash Hira, professor of Global Health, University of Washington, USA, said, "National regulatory bodies like the Ministry of Health assemble teams of experts to develop 'national treatment guidelines' for every disease. These are revised frequently depending upon new developments and findings, both nationally and internationally." He added, "The treating doctors are required to follow the guidelines and provide feedbacks to the MOH. Any available medicines under "repurposed" use for COVID-19 should also be approved by the regulatory agency and put in to revised treatment guidelines before these medicines are prescribed."

However, countering this, Dr Shaikh stated that no drug can be used in any disease without positive result from trials. But if these drugs have to be used, they should be purely used on an emergency and experimental basis.

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