The Dhaka Times Desk A drug called Remdesivir is being used in the treatment of Corona. This drug is produced by 6 pharmaceutical companies in Bangladesh. Why is the United States calling Remdesivir 'effective' without enough research?
A couple of weeks ago, the announcement of the drug manufacturer Gilead Sciences started a worldwide uproar that a study by the National Institutes of Health (NIH), the United States government health agency, showed that the use of a drug called Remdesivir in the treatment of Covid-19 was very beneficial. After the death of two and a half lakh people, there is hope in the minds of the people of the world that the best weapon to fight the corona virus epidemic has been found.
But behind this light of hope there is a dark complex chapter! Determining how safe and effective a new drug is for patients is often difficult. There is also a lot of complexity regarding the stage at which the research should be completed. Recently, many discussions and criticisms are going on for and against the sudden termination of research on Remdesivir and declaring it effective in the treatment of Corona.
A detailed report on this issue has been published by US health website statnews.com. Its magnetic part is highlighted as-
For the National Institute of Allergy and Infectious Diseases (NIAID) of the United States, the decision to give remdesivir to corona patients was quite complicated. Remdesivir was administered to some patients who were supposed to be given a placebo (a drug without side effects; eg, saline) for research purposes. The trial found that 8 percent of patients treated with remdesivir died. In contrast, the mortality rate among placebo recipients was 11.6 percent. That is, there was no major change in life expectancy with the use of remdesivir.
But there is no regret in the minds of NIAID officials. H. Clifford Lane, the institute's clinical director, said, 'That's right, there was consensus across the institute.'
"Patients receiving remdesivir had their oxygen support discontinued or discharged within 11 days of their hospital stay, at least four days less than those receiving placebo," he added.
But Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, disagrees with Lane. He said, 'We have closed (lockdown) the entire society not to reduce the time spent in the hospital by corona patients, but to prevent the death of patients.'
When the remdesivir results were announced, the NIH said the data came from an internal analysis. That is, the study was quickly terminated. The reason is that they were so sure about the effectiveness of this drug that they did not even think it necessary to continue researching it. However, Clifford Lane thinks that this decision was not the right decision at all. According to him, it was necessary to publish the results only after the research was completed naturally.
The ACT (Adaptive Covid-19 Treatment Trial) study of remdesivir began last February. The patient who received its first dose was a US citizen who contracted the virus from the Diamond Princess cruise ship. As part of the study, hospitalized patients were given either remdesivir or a placebo. At the end of 15 days, the result of this study was that one in every 8 people died, that is, 1 person died against 8 healthy people.
However, after hearing about research on remdesivir in China as well, Len and his team thought that waiting 15 days might result in a complete failure of the drug, even if the drug was beneficial. That's why they decided to change the type of research on March 22. The study will instead measure the condition of patients on an 8-point scale per day, until patients reach one of 3 pre-determined outcomes. On April 2 the decision was finalized that; It was then posted on clinicaltrials.gov, the government registry of clinical trials, on April 16.
Interestingly, even if the type of research was not changed, the results would have been positive, according to H. Lane. As the nature of this research has changed, so has the nature of its analysis. Now the NIAID has decided that the analysis will be from the time when 400 of the 1,63 patients have recovered.
These results are usually analyzed by an independent expert committee called DSMB (Data and Safety Monitoring Board). Although anonymous, they are the most important and powerful alliance in medical research. Their job is mainly twofold: to ensure that experimental drugs do not harm patients and to be more certain that the drug is undoubtedly effective.
But the DSMB has not done any analysis of the remdesivir study, Clifford Lane said. All patient data were collected in this study by April 20. A meeting of the DSMB was scheduled to take place on April 22, but it was cancelled. The committee met on April 27 and made a recommendation to NIAID that day.
That recommendation made no mention of whether or not remdesivir should be given to placebo patients! Instead, it recommended the next phase of the DSMB study, which calls for Eli Lilly's arthritis drug Olumiant to be tested against remdesivir.
Based on this recommendation, the NIAID concluded that remdesivir could be given to all patients receiving placebo. This program has been started from last April 28.
However, Lane has second thoughts on this matter. According to him, only 1 thousand 63 people were tested out of which 480 people recovered. Researchers could have collected more information on this.
In this case, the most unusual thing is that the United States Food and Drug Administration (FDA) has approved the use of remdesivir in the treatment of corona before the results obtained in the study have been fully analyzed. On the other hand, a Chinese study found remdesivir to be ineffective. The results of some more studies on this may be published soon. The related experts think that more details will be known about this.
However, one thing needs to be mentioned here that it has been decided to use Remdesivir in the treatment of corona patients in Bangladesh. That is why the drug administration has given permission to 6 companies to manufacture this drug. If there is so much criticism about this drug, how can Bangladesh take the initiative to use it? That is the question now.
Things to do to prevent Corona virus
# stay at home all the time.
# Follow the rules and use mask when going out for emergency.
# three-layer surgical mask can be washed if desired.
# wash clothes after coming home from outside. Or hang it without shaking for at least four hours.
# Wash hands thoroughly (for at least 20 seconds) with soap or liquid before coming outside.
# plastic PPE or eyes, mouth, head after single use
Of course it can be washed thoroughly with detergent and dried.
# Wear PPE made of cloth or clean as described.
# Use a head cap that completely covers the hair.
# Those who have sneeze cough should follow all the rules promulgated by the government. Also, wash hands as directed before and after handling food items, keys, switches, mice, remote controls, mobiles, watches, computer desks, TVs, etc. and after using the bathroom. Those who have dry hands use Moisture after washing their hands. Soap or hand liquid can be used. Why can this virus remain in the crackle (cracked part) of dry hands? Avoid using highly alkaline soaps or detergents.
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