Patanjali’s ‘breakthrough’ needs vetting, say experts
The principal investigator running the clinical trial at a Jaipur medical college confirmed the findings but said they were preliminary and the study, ongoing.Updated: Jun 25, 2020 08:04 IST
India’s traditional systems of medicine, including ayurveda, have several proven preventive and curative drugs and therapies, but Patanjali Ayurved Ltd’s claim of a breakthrough cure for the coronavirus disease (Covid-19) needs vetting, experts said, despite the company claiming to have conducted a randomised placebo-controlled clinical trial.
The principal investigator running the clinical trial at a Jaipur medical college confirmed the findings but said they were preliminary and the study, ongoing. He also clarified that the study was conducted on patients who were asymptomatic or had mild symptoms, between the ages of 35 and 45, and that no people with co-morbidities (considered the most vulnerable to the disease) were part of the trial.
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Interestingly, a spokesperson for Patanjali, SK Tijarawala said that the company never “claimed that it (the medicines) were a cure for coronavirus disease; all we said was that the medicines in our kit that Patanjali has been selling individually to boost immunity and provide relief to patients of respiratory illness has been effective in improving symptoms of Covid-19 patients”.
Patanjali submitted (preliminary) results of the clinical trial to the ministry of Ayush (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) only after the latter demanded ”facts of the claim and details of the stated scientific study”. That came after the company, promoted by yoga guru Baba Ramdev, went public with its discovery. He was later interviewed by several TV channels where he talked up the discovery. The scientific title of its clinical trial, according to documents submitted by the company is : Impact of Indian traditional Ayurvedic treatment regime for nCov-2 (Covid-19)
On Tuesday, the ministry also directed the company to stop advertising the product till the claim was verified.
The Ayush ministry is currently in the process of examining the documents.
“It’s a good thing that Baba Ramdev has given a new medicine to the country, but as per rules, it has to come to the Ayush ministry first. They even said that they have sent a report; we will look into it and permission will be given after seeing the report,” Ayush minister Shripad Naik told news agency ANI on Wednesday.
It wasn’t immediately clear how the company launched its product without a clearance from the ministry.
A senior official in the ministry of Ayush added on condition of anonymity that the claims made by Patanjali were being verified by experts in the ministry.
“We weren’t aware of it (the drug) until yesterday (Tuesday), and now that they have submitted the documents, our experts will be examining it before anything is said conclusively. There is a protocol for conducting clinical trials for any medicine under the Ayush system that we have notified, so we will examine what kind of approvals they have, and what type of trial was conducted with the primary and secondary objective. All technical parameters will be examined,” the official said.
According to the trial data submitted by the company, in a double blind single centre randomised study at a hospital in Jaipur, the National Institute of Medical Sciences, the drug was tested on 120 patients. The primary outcome was the virological clearance in a RT-PCR test at “baseline”, after three days, and after seven days.
The secondary outcome was reduction in Serum C reactive protein (CRP) and IL-6 levels. High CRP and IL-6 levels are an indicator of inflammation.
According to the findings of the trail, there was a 69% recovery on Day 3 in the treatment group, and 100% recovery at Day 7, which was 35% better recovery than the placebo group. The documents said that “Serum CRP levels are lesser in treatment group” and that there was a “remarkable decrease in IL-6 levels”.
According to Dr Ganpat Devpura, a professor of medicine at NIMS and the principal investigator of the trial, by design, excluded people with co-morbidities and the age of patients studied was 35-45 years . He also added that the patients were either asymptomatic or mildly symptomatic because those were the kind of patients available for the trial at the hospital.
Clinical trials usually have wider samples -- for instance, before being approved, allopathic medicines go through trials that sometimes involve tens of thousands of people.
Several voices have raised concerns about the trial design since Tuesday when Patanjali made the results public.
“The #PatanjaliAyurved trial enrolled 120 COVID+mildly ill patients & looked at viral clearance and decrease in IL-6 levels as endpoints. IL-6—the indicator of severe inflammation & cytokine storm—is unlikely to be elevated early in these patients. How would the drug impact it?” tweeted SP Kalantri, who identifies himself as a physician, teacher and researcher among other things.
Indeed, some of the findings may not be a measure of the efficacy of the drugs being tested, another expert said: Explaining the implications, Dr Yatin Mehta, chairman, critical care, Medanta Hospital, said: “In early stages of the disease it’s highly unlikely that a patient will develop cytokine storm indicated by high levels of c-reactive protein and IL-6. Almost 80-90% cases are mild who would recover on their own anyway so if the resolution being talked about is reduction in IL-6 or CRP levels then for mild cases it doesn’t seem to be suitable.”
“These are just initial findings and not yet peer reviewed. We will submit final results to Central Council for Research in Ayurvedic Sciences for review but it should take about a month or two. The trial is still on-going. As to why the company has already begun manufacturing the drug you must ask the manufacturer. I cannot comment on that,” said Dr Devpura.
Pantanjali spokesperson Tijarawala reiterated that no rules were flouted. “Everything is in order; nothing has been violated. medicines have been in use for years, and we only lent scientific validity to its results.”
While the drug trial is registered with the central trials registry of India (CTRI) , which is run by the Indian Council of Medical Research (ICMR), the data has not been yet uploaded on the site.
“The results will be uploaded on CTRI website soon,” said Patanjali in its documents submitted to the Ayush ministry.
Dr Anurag Agarwal, director, CSIR-Institute of Genomics and Integrative Biology, said everything depends on the data and the design: “Interim results can be useful in some cases, but it all depends on the study design. If the results aren’t out in public domain that it becomes difficult to say.”
ICMR, however, said registering with CTRI is just a small part of the clinical trials process, and that the crucial part is declaring and getting the results vetted. The findings of the study are also yet to be peer-reviewed.
“The data has to be made public and reviewed by experts, which in this case is the ministry of Ayush. There are several approvals such as institutional ethics committee’s approval, and factors such as number of trial participants and the quality of data generated and where it is published that are to be considered. CTRI can only enrol but efficacy and non-efficacy is different process altogether that we cannot comment on but is for the Ayush ministry to verify,” said Dr Rajnikant Srivastava, spokesperson ICMR.
Meanwhile Uttarakhand’s licensing department for Ayurveda told news agency ANI, “As per Patanjali’s application, we issued them a license. They didn’t mention coronavirus, we only approved license for immunity booster, cough and fever. We will issue them notice asking how they got permission to make the kit.”
Patanjali’s Tijarawala added that the “state Ayush department has been in the loop all throughout and adequate permissions were sought from it for the use of these medicines in combination”.