An anti-COVID drug developed by the Defence Research and Development Organisation (DRDO), which received emergency use authorisation from the Drug Controller General of India (DCGI), was launched on Monday, 17 May.
Union Defence Minister Rajnath Singh distributed around 10,000 doses of the same to some hospitals in the national capital.
The treatment which was developed by the DRDO in collaboration with the pharmaceutical company Dr Reddy’s Laboratory involves the ‘therapeutic application of the drug 2-deoxy-D-glucose (2-DG)’ for moderate to severe COVID cases.
In its statement, the Ministry of Defence has said, "clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence."
This treatment, the ministry hopes, will help combat the severe oxygen dependency and hospitalisation that has been rampant in the second wave.
But how robust is the study? And why are many experts not convinced?
Faulty Design, Limited Data: Experts Not Convinced With DRDO Drug
1. What Is the Drug?
DRDO-Dr Reddy's drug involves the therapeutic application of 2-deoxy-D-glucose (2-DG), a glucose molecule for the treatment of COVID.
The particular drug will be available in powder form and is meant to be dissolved in water and administered orally.
Once consumed, it spreads throughout the body and works on the virus-infected cells in a targeted manner, says DRDO.
“It accumulates on the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production.”
The Ministry of DefenceThey also add that "its selective accumulation in virally-infected cells makes this drug unique."
Dr Sudhir Chandna, a scientist at the Institute of Nuclear Medicine and Allied Sciences (INMAS)-DRDO, has said that the drug is safe and should be available for use by next month, reported Mint.
Expand2. Limitations With Clinical Trials
Laboratory experiments by DRDO in collaboration with the Centre for Cellular and Molecular Biology (CCMB) is said to have started in April 2020.
Based on the data collected in this, the DCGI granted permission to take it forward and conduct phase 2 clinical trials to test the safety and efficacy of the drug in May 2020.
The emergency use approval was granted to the drug based on data from phase 3 clinical trials which was presented to the DCGI.
The phase 3 clinical trials were conducted in November and involved 220 participants across 27 COVID hospitals in 10 states.
According to their statement, during this trial, by Day 3, 42 percent of the participants in the 2-DG arm improved symptomatically and became free from supplemental oxygen dependence, as compared to the 31 percent in the group that received standard care.
Similar results have also said to have been observed in those over the age of 65 years.
Expand3. Why Are Researchers Not Convinced?
Some researchers have questioned the opacity of the drug's primary trial results and the lack of peer-reviewed research papers available in the public domain.
Dr Reeteka Sud, Neuroscientist at NIMHANS Bengaluru, among other researchers, has pointed to the lack of access to the data from the clinical trials.
Others have pointed to the inadequate sample size used in the phase 3 trials that involved 220 participants when, according to the US FDA, the number should usually range between 300-3,000.
Researchers have also pointed to the unsatisfactory description of the primary outcome of the trial.
Dr Varun C explains the problem with this in a Twitter thread. He says when primary endpoints (what is the trials meant to achieve) are not recorded at the beginning of the trial, it allows the makers to point out at any possible outcomes as its end point post trials.
It has also been pointed out that 2-deoxy-D-glucose is an already existing drug used for cancer treatment.
While it is laudable that the DRDO and their research partners were able to repurpose the drug for treating COVID, to claim they 'developed' it, or that it is a 'new drug' (like many media outlets are doing) would be unethical.
And while having an anti-COVID medicine as this – which is both easy to produce and administer – that could reduce dependency on oxygen and hospitalisation would be a godsend at the point we're at, the data will have to be published and reviewed before its safety and efficacy can be fully assessed and accepted.
(This story was first published in FIT and has been republished with permission.)
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)
Expand
What Is the Drug?
DRDO-Dr Reddy's drug involves the therapeutic application of 2-deoxy-D-glucose (2-DG), a glucose molecule for the treatment of COVID.
The particular drug will be available in powder form and is meant to be dissolved in water and administered orally.
Once consumed, it spreads throughout the body and works on the virus-infected cells in a targeted manner, says DRDO.
“It accumulates on the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production.”The Ministry of Defence
They also add that "its selective accumulation in virally-infected cells makes this drug unique."
Dr Sudhir Chandna, a scientist at the Institute of Nuclear Medicine and Allied Sciences (INMAS)-DRDO, has said that the drug is safe and should be available for use by next month, reported Mint.
Limitations With Clinical Trials
Laboratory experiments by DRDO in collaboration with the Centre for Cellular and Molecular Biology (CCMB) is said to have started in April 2020.
Based on the data collected in this, the DCGI granted permission to take it forward and conduct phase 2 clinical trials to test the safety and efficacy of the drug in May 2020.
The emergency use approval was granted to the drug based on data from phase 3 clinical trials which was presented to the DCGI.
The phase 3 clinical trials were conducted in November and involved 220 participants across 27 COVID hospitals in 10 states.
According to their statement, during this trial, by Day 3, 42 percent of the participants in the 2-DG arm improved symptomatically and became free from supplemental oxygen dependence, as compared to the 31 percent in the group that received standard care.
Similar results have also said to have been observed in those over the age of 65 years.
Why Are Researchers Not Convinced?
Some researchers have questioned the opacity of the drug's primary trial results and the lack of peer-reviewed research papers available in the public domain.
Dr Reeteka Sud, Neuroscientist at NIMHANS Bengaluru, among other researchers, has pointed to the lack of access to the data from the clinical trials.
Others have pointed to the inadequate sample size used in the phase 3 trials that involved 220 participants when, according to the US FDA, the number should usually range between 300-3,000.
Researchers have also pointed to the unsatisfactory description of the primary outcome of the trial.
Dr Varun C explains the problem with this in a Twitter thread. He says when primary endpoints (what is the trials meant to achieve) are not recorded at the beginning of the trial, it allows the makers to point out at any possible outcomes as its end point post trials.
It has also been pointed out that 2-deoxy-D-glucose is an already existing drug used for cancer treatment.
While it is laudable that the DRDO and their research partners were able to repurpose the drug for treating COVID, to claim they 'developed' it, or that it is a 'new drug' (like many media outlets are doing) would be unethical.
And while having an anti-COVID medicine as this – which is both easy to produce and administer – that could reduce dependency on oxygen and hospitalisation would be a godsend at the point we're at, the data will have to be published and reviewed before its safety and efficacy can be fully assessed and accepted.
(This story was first published in FIT and has been republished with permission.)
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)