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Science vs nonsense: On Patanjali’s COVID-19 claim
ICMR, CSIR must call out any breach of due process in the appraisal of any drug
The unrelenting spread of COVID-19 has set off both mass anxiety and a clamour for a panacea. Fear paves the way for profiteers. Patanjali Ayurved’s recent claim of having discovered a “cure†and the publicity that this garnered, bypassing every regulatory requirement without any serious consequence so far, shows that India’s regulatory checks and balances are wanting. The company said in Haridwar that its product, ‘Coronil’, had cured everyone in a clinical trial. While quackery and the potency of ‘magic drugs’ are a part of life in India, its declarations could not be ignored because of the tremendous influence its products wield and its claim to have proved the product through a clinical trial, which makes it open to evaluation by the standards of modern medicine.
As it now emerges, the company has probably misrepresented the drug’s efficacy. The clinical trial tested the drug on 45 and another 50 were administered a placebo. All of the participants had tested positive for the virus. On the third day, 31 who were given the drug recovered and 25 of those on the placebo recovered. That is not a measurable improvement considering the small number enrolled in the trial. Moreover, they were mildly symptomatic. Ramdev claimed that by the seventh day, all had recovered. If this also included all those on the placebo, then it further weakens the claim that it was the drug alone that worked. The doctors in the trial have spelt out on the clinical trials registry the process they would employ to test the drug but said they had neither published their results nor submitted it for peer-review. Therefore, the company’s claim of a cure by all accounts was a clear subversion of the scientific process. When hydroxychloroquine was being touted as a potential wonder drug for COVID-19, some of India’s scientists were quick to join a global opprobrium that raised methodological issues with a study in The Lancet, that claimed no effect — and even harm — from HCQ. The study was retracted as it relied on a spurious database. But its overall finding that HCQ does not work has been borne out by other validated studies. Thus, more than the outcome, it is the method deployed that ought to be scrutinised by scientists to reinforce public trust in scientific assessment. There has always been a tension between traditional Indian systems of medicine and pharmaceutical drugs but there is now consensus in India’s regulatory system that claims by both systems of developing safe efficacious drugs must pass clinical trials. It is well within the domain of institutions of the ICMR or the CSIR or national science academies to call out a breach of due process in the appraisal of any drug, whether allopathic, ayurvedic or homeopathic. To not do so would amount to criminal negligence.
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Editorial
Scientific disinterest: On Health Minister’s presence at Coronil promotion event
Ministers and public figures must not be seen as endorsing drugs whose efficacy is in doubt
The presence of Union Health Minister Harsh Vardhan at a press conference to promote Coronil, an Ayurvedic pill promoted by Baba Ramdev’s Patanjali Ayurved, is objectionable on more than one count. Coronil is a concoction of common herbs known to Ayurveda. Since June, there have been attempts to deploy it into India’s COVID-19 management protocol. Dr Vardhan, alongside Cabinet colleague Nitin Gadkari, was at a press conference with Baba Ramdev and other promoters of Patanjali to announce a scientific publication describing the efficacy of Coronil in ridding volunteers, part of a clinical trial, of coronavirus. For one, Coronil is a product manufactured by a private company. Doctors — Harsh Vardhan is an ENT surgeon — are explicitly barred from promoting drugs of any sort. Though Dr Vardhan didn’t explicitly mention Coronil in his address at the function, what public functionaries are seen to be doing speaks louder than what they say. Baba Ramdev first claimed that his product was endorsed by the WHO. Following media reports, WHO South-East Asia tweeted that it hadn’t reviewed or certified the effectiveness of any traditional medicine for the treatment of COVID-19. What transpired was that India’s apex drug regulator had certified Coronil as a pharmaceutical product in “supporting COVID treatment and an immunity booster†and cleared it for export. It hasn’t recommended it as treatment for COVID-19.
The publication of a double-blinded, randomised clinical trial in a research journal isn’t an endorsement of a product, but an essential requirement of reporting the drug’s action to subject experts. The report reveals that the medicine was only tested on 95 of those asymptomatic and “mildly symptomatic†but confirmed as RT-PCR positive. The 45 patients who got the actual treatment (and not a dummy pill) tested COVID-19 negative significantly quicker. However, these numbers are small. A large proportion of those with mild or no symptoms are expected to clear out the infection without any external intervention. There was no information in the study on the number of days that elapsed before the patients tested positive, making the role of the drug in clearing out the virus unclear. True, allopathic medicine too has cut corners: an ICMR-led trial ultimately couldn’t justify the administration of hydroxychloroquine; the Drugs Controller General of India approved itolizumab by Biocon that was tested only in a sample of 30 but was advertised as a “breakthrough drug†; and Covaxin was approved before its efficacy was known. Processes are imperfect, but the government must demonstrate its scientific disinterest when evidence is wanting.
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The Times of India, June 25, 2020
Editorial
Follow protocols: Drugs claiming to be Covid cures without scientific standards should not be allowed
Times of India’s Edit Page team comprises senior journalists with wide-ranging interests who debate and opine on the news and issues of the day.
In a prudent move, Ayush ministry has directed Baba Ramdev’s Patanjali Ayurved to stop advertising and publicising its claims about its recently launched Covid-19 treatment medicines. Patanjali was touting its latest ayurvedic formulations, Coronil and Swasari, as the world’s first cure for Covid. In fact, it claimed that clinical trials had been conducted for the formulations and that 69% of the Covid-positive test subjects turned negative in three days while all test subjects were cured in a week. However, Ayush ministry has said that it was neither aware of the facts of Patanjali’s claims nor cognisant about the scientific study carried out on the formulations.
The ministry has now asked Patanjali to provide it with details of the medicines and results data of the study. This is welcome as finding effective treatment for Covid is serious business. All medicines and vaccines have to undergo rigorous trials and scientific validation processes. Therefore, one should be extremely wary of drugs being proclaimed as Covid cures without going through government approved processes.
Such unverified cures will end up doing more harm as people may avoid scientific treatment protocols and go for these so-called magic potions, thinking they are thereby protected from infection. With more than 4.5 lakh Covid cases and counting in India, the last thing we need is people falling for unapproved drugs and becoming super spreaders. In fact, Ayush ministry itself had issued a circular to states on June 2 to take necessary action against instances of misleading information, fake claims and misbranding of products in relation to Covid control. Plus, the regulatory framework for alternative medicines has been generally weak. Ayurveda may embody ancient Indian medical wisdom. But its application in the 21st century must adhere to recognised scientific protocols. This is no time for alchemy.
SEE ALSO:
A cure for COVID-19: Only science can combat virus. Scientific community must not remain silent on tall claims
Even though COVID-19 continues to rule and ruin our daily worlds, it still does not give the right to the righteous of the land to promote cures, remedies and preventions which are beyond the realm of their understanding and operation. Prudence is the need of the hour and prudence comes from wisdom.
Written by Shah Alam Khan ( June 27, 2020)
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Another First: Health Minister Pushes Unproven Covid Drug
by Suhit K Sen (25 Feb 2021) https://www.newsclick.in/Another-First-Health-Minister-Pushes-Unproven-Covid-Drug
