Coronavirus 2-DG drug: Regulator nod cuts little ice with doctors; experts flag unreliable clinical data

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May 20, 2021 5:55 PM

Refusing to prescribe the drug as of now, Dr Sumit Ray from Holy Family Hospital said there is a sea of difference between theoretical value and clinical outcome and the team of researchers have not shown any significant clinical outcomes so far.

However, as per the details uploaded on the trial registry only 40 patients participated in the phase 2 trials.However, as per the details uploaded on the trial registry only 40 patients participated in the phase 2 trials.

Even as the central government has launched the 2-DG (2-deoxy-D-Glucose) drug which it has claimed reduces the recovery time and oxygen requirement of Coronavirus patients, a large section of experts and medical fraternity have expressed doubts about the efficacy of the drug. According to an Indian Express report, the launched drug has been previously used in cancer treatment and helps prevent the process of glycolysis through which the replicating virus gets energy. Even as the drug appears to be the right prescription in theory, doctors and many health experts have said that in the absence of robust clinical data they cannot use it for Coronavirus patients.

The drug launched by Defence Research Development Organisation (DRDO) in association with pharma major Dr Reddy’s Laboratories is based on a paper written by a team of researchers at Haridwar’s Patanjali Research Institute. The paper which is not peer reviewed has Acharya Balakrishna, chairman, Patanjali Ayurved as its lead author. The paper has also been cited in the January-February 2021 issue of the Indian Council of Medical Research’s (ICMR) Indian Journal of Medical Research. Other authors of the research paper include a majority of members associated with the Patanjali Institute and some members from Vivekanand Education Society’s Institute of Technology, Jain Vishva Bharati Institute and Chennai-based SIMATS, Saveetha Institute of Medical and Technical Sciences.

Dr Shashank Joshi who is a member of the Maharashtra Covid task force told the Indian Express that he would only prefer using the drug in research mode until more data is available in public domain. Dr Joshi also said that the clinical trials have not been conducted for diabetics and patients suffering from coronary artery disease.

Director of the Lok Nayak Jai Prakash Narayan (LNJP) Hospital Suresh Kumar told the Indian Express that it needs to be watched how the drug performs in patients who have been prescribed the drug. Refusing to prescribe the drug as of now, Dr Sumit Ray, head of critical care at Holy Family Hospital told the Indian Express that there is a sea of difference between theoretical value and clinical outcome and the team of researchers have not shown any significant clinical outcomes so far.

In addition to the lack of significant clinical data, health experts have also flagged lack of transparency in the regulatory approval granted to the drug. The Indian Express reported that as per the press release issued by the Ministry of Defence, the drug clinical trial phase 2 had a total of 110 patients. However, as per the details uploaded on the trial registry only 40 patients participated in the phase 2 trials. Even after the passage of more than 20 days since the emergency use approval was granted to the 2-DG by the Drug regulator, the minutes of the meeting of the Subjects Expert Committee have still not been made public by the regulator.

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