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Patanjali Ayurved Ltd on July 1, 2020, said its Coronil and Swasari drugs, were cleared by the Union Ministry of Ayurveda, Unani, Siddha and Homeopathy or AYUSH. The company had earlier claimed the drugs could cure the novel coronavirus disease (COVID-19).
However, despite the ‘go-ahead’ of the government, significant questions remain unanswered.
Patanjali founder Ramdev told reporters in Haridwar the drugs would soon be available in the market. The AYUSH ministry had halted the publicity of drugs eight days ago.
After the press conference, an AYUSH ministry spokesperson said: “AYUSH ministry has only given permission to sell this particular product as immunity booster and not as a medicinal cure for COVID-19.”
Ramdev did not use the word ‘cure’ as well. But he reiterated that he stood by the ‘results’ of the clinical trial which he put out last week. Ramdev’s aide, Balkrishna, did use the Hindi word “theek” at least twice in the hour-long press meet in terms of result. “Theek” in English can translate to cure.
The Central Trials Registry of India (CTRI) has details about the trial design on the basis of which the AYUSH ministry has given permission to Patanjali. The details are reflected here according to the information given by the agency conducting the trial.
The title, according to CTRI, of the trial is, ‘Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19)’. The word ‘treatment’ is present in the title itself while AYUSH’s spokesperson said the permission granted to the drugs was only for ‘immunity boosting’ and not cure.
There is another issue. “When the researchers designed the trial, they wanted to test its effectivity in patients with lab-proven COVID-19, not its preventive ability. The researchers are also talking about its preventive capacity (boosting the immune response),” SP Kalantri, medical superintendent at the Mahatma Gandhi Institute for Medical Sciences (MGIMS) in Sevagram, said.
“In no scientific trials is one allowed to change what is known as outcomes in the scientific parlance,” Kalantri added.
AYUSH ministry under scanner
The role of the AYUSH ministry is under the scanner for other reasons too. It sent a letter to the Uttarakhand state licensing authority, with a copy to Patanjali Ayurved on June 30.
“It has been observed that M / s Divya Pharmacy, Patanjali Research Foundation Trust has initiated necessary activities for the management of COVID-19 which is duly noted,” the letter said.
Ramdev now stresses that his drugs are for the ‘management’ of COVID-19, and not cure. “The scientific trials are designed to test either the ability of the drug to prevent a disease (prophylaxis) or its effectivity in achieving desired outcomes (treatment). We do not use the word “management” in a clinical trial,” Kalantri, who specialises in clinical research, said.
“It seems the ministry left it deliberately vague so that the Patanjali could use it to its advantage,” he added.
Anant Bhan, a bioethics expert, said this could be fraught with serious ramifications. “Management is a vague term. Till there is no scientific paper, or even a pre-print which can guarantee either treatment or prevention, we can’t believe in either outcomes. But people may not understand this,” he said.
“If Ramdev actually succeeds in transferring these drugs to stores, people may do panic buying. This may install a false sense of security in people and they may throw all social distancing norms to the winds. This will end up exacerbating the disease,” he added.
Down To Earth (DTE) called up and sent text messages to AYUSH ministry secretary Rajesh Kotecha to ask these questions. None were answered.
The phone calls and text messages sent to Uttarakhand Ayurved department licensing authority YS Rawat also did not yield a reply. DTE called up Patanjali’s spokesperson SK Tijarwala for a formal statement and a few follow-up questions. He disconnected the call even before questions could be put up.
But even if one were to get beyond the jugglery of words between the AYUSH ministry statement and Ramdev’s claims, there are still serious conflicting concerns.
Scientific claims not enough
The press release put out by Patanjali on July 1 reads: “Blood serum levels of C-reactive proteins (CRP), Interleukin-6 (IL-6) and TNF alpha cytokines were also detected to be significantly lower in Patanjali medicine treated COVID-19 recovered patients, than the placebo group.”
There are two arms of a randomised control trial — one which receives active form of the drug and the other which gets inactive form (also known as placebo group). The effect of drug on two arms is designed to compare and contrast the results between the two.
‘CRP’, ‘IL-6’ and ‘TNF alpha’ are cytokines whose levels get released multiple times in response to a serious infection. If one gets cured or treated, their level gets lowered. If cytokine levels are getting reduced, going by Ramdev’s own claims for the sake of argument, then this precisely means a cure. So, while Ramdev might avoid the word ‘cure’, as the AYUSH ministry is, but he is meaning exactly the same.
The press release also said 95 ‘mild’ and ‘moderately ill’ patients participated in the trial and cytokines level were detected to be significantly lower in ‘Patanjali medicine treated COVID-19 recovered patients’.
“In mildly ill patients, the cytokine levels don’t go up. They take their time to rise and do so in severely ill patients. The claim that the drug reduced the cytokine levels in all the patients sounds inexplicable,” Kalantri said.
This claim of reduction in cytokine levels is problematic at another level also. “Just to state simply that the levels got lowered is not how you communicate in science. We need to know the effect size and its precision. We also need to know how it was decided that a sample size of 90 patients was enough to understand the difference between two arms of the trial, if it existed,” Kalantri said.
“As for safety of the drug, the study mentions no adverse events in any study participant — a fact biologically impossible to accept. Normally, no new drug — Ayurvedic drugs included — is completely adverse-event free in all study participants,” Kalantri said.
These details can be known only if they are shared via a research paper in a journal, as a pre-print paper or even through press statements. DTE reached to the trial’s principal investigator Ganpat Devpura who is working with Jaipur-based National Institute of Medical Research and Sciences. “We have not yet shared results with CTRI. Once that is done, we will share with journals,” he said.
Asked if he could share those results with DTE as a press statement like pharma firms across the world are doing, Devpura replied in the negative. This, despite Ramdev claiming that these results had been shared with the AYUSH ministry.
The ministry, in turn, has so far refused to put these results either in the public domain or sharing with the media despite requests.