It was time for dinner when he called for help. Before this call, we spoke only twice, when she was looking to fill a position in a media house several years ago.
“I need remdesivir at any cost for my father who is hospitalized due to covid-19. I need to save her,” he told me over the phone in a desperate, weeping tone.
He told me that this was not his first attempt at finding a drug. In fact, she managed to buy a vial remdesivir For Rs.30,000 – More than five times the (erstwhile) basic MRP of Rs.5500.
But her father’s doctor, who is being treated at a reputed hospital in central Delhi, told that the vial is “probably fake”.
“The person who sold it to me promised it was genuine. Now, his number is locked and our doctor says the vial is not closed enough.”
Since then, for the next three days, I made several calls, but all my attempts failed. I checked with everyone – from state drug controllers to executives from top pharma companies, but the vials were not found.
It was the last week of April and we were in the middle of a dreadful second wave of covid. Every possible communication platform – including Twitter, Facebook, Instagram and WhatsApp status messages – was flooded with emotional appeals to find plasma donors or remdesivir.
Fortunately, his father survived. He began to respond to treatment, which included steroids but not remdesivir or plasma.
This column is not about him. But this is about relatives – son, daughter, wife, sister or any other relative – who failed to get remdesivir and their loved ones failed to survive.
Free yourself from the guilt of not being able to save them with remdesivir. It was an experimental drug, but never a miracle drug.
Dr Pratima Murthy, director of NIMHANS, told me in October that many relatives who have lost loved ones to COVID call their national helpline number to share their grief and inability to save. They are haunted by memories of a drug struggle and continue to grieve.
Read also | India cuts use of remdesivir, tocilizumab, multivitamins, steroids in Covid-19 treatment
The National Institute of Mental Health and Neurosciences (NIMHANS) runs a 24×7 national helpline (080-4611 0007) to handle distress calls related to Covid-19.
Forever, remdesivir and plasma were never as effective as we thought.
Here is the proof.
plasma It was removed from the country’s COVID-19 treatment guidelines after several studies proved fruitless. Duration.
Now addressing the elephant in the room—the usefulness of remdesivir.
In India, the Ministry of Health and Family Welfare has further downplayed the role of remdesivir in the treatment of Covid-19.
It can only be given to patients who require oxygen support but are not on ventilator support or ECMO. Therefore, this drug can be given to a very small subset of patients.
The guidelines clearly state that there is “no evidence of benefit” of the drug for more than five days of treatment.
Many doctors believe the government is “playing safe”.
“They are trying to mark all the boxes,” a doctor told me. “The drug is part of the treatment protocol as till date, there is only one approved anti-viral for COVID-19. They don’t want to use it, but want to keep it.”
In November 2020, long before the outbreak of the second wave, the World Health Organization issued a conditional recommendation against the use of remdesivir in hospitalized patients, regardless of disease severity, saying that “there is currently no evidence of that remdesivir improves survival and other outcomes in (Covid 19) patients”.
Available evidence based on WHO’s Solidarity Trial – suggested no significant effect on all parameters – mortality, need for mechanical ventilation, time to clinical recovery, and other patient-important outcomes.
The Solidarity trial conducted in 405 hospitals in 30 countries on patients hospitalized with Kovid-19 showed that 2,750 patients remdesivir 2,708 patients were expected to die on standard care. The drug did not reduce the mortality rate or the time taken for Covid-19 patients to recover.
In the DisCoVeRy trial sponsored by the French government, the European Union Commission and others, the drug showed no clinical benefit.
Some authors have, in the past, received lecture fees or individual fees from Gilead Sciences – in both the WHO’s Solidarity Trial and the Recovery Trial. The disclaimer showed that no one had a significant role in the company.
“If we combine data from five clinical trials involving more than 7,000 patients with COVID-19, remdesivir did not reduce the risk of death nor mechanical ventilation compared to standard of care (routine treatment). was needed,” Dr. SP Kalantari, professor of medicine at a medical college told me.
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“This should reassure the public that it is not a life-saving drug,” he concluded.
Only 9 lakh patients got Remdesivir?
IQVIA data shows that only 54 lakh vials have been sold between November 2019-2020 and November 2020-2021. Six vials are needed to treat one patient. The usual prescription is – 2 vials on the first day, and then 1 vial a day for four days.
Assuming that everyone managed to complete the full course of medicine, only nine lakh COVID patients ended up taking the medicine. In contrast, India has already seen more 3.80 crore covid cases and nearly 5 lakh deaths.
Since the drug was widely available on the black market, there is no clarity on the actual number of vials sold in India.
Nonetheless, in less than two years, the revenue earned through legitimate channels is around Rs 1,500 crore.
Studies to Support Remdesivir
In a recent study published in the New England Journal of Medicine, researchers from Baylor University Medical Center and affiliated institutions found that a three-day course of remdesivir increased the risk of hospitalization in symptomatic, non-hospitalized Covid-19 patients. reduced by 87.5%. , The study is funded by Gilead Sciences – the originators of the drug.
In addition, the manuscript was produced by an author employed by Gilead Sciences with input from all authors.
Another latest study, led by researchers at Johns Hopkins Medicine, supports the use of remdesivir for patients with low flow oxygen or no oxygen. The study’s lead author, Dr. Brian Garibaldi, received consulting fees from Gilead Life Sciences Inc. – the study clarifies in the column under Disclosures of Conflict of Interest. In addition, he is a member of the Pulmonary-Asthma Drug Advisory Committee of the US FDA. The US FDA is the agency that made Remdesivir a wonder drug by making it the first drug to be approved for use in Kovid patients.
Another latest Canadian study suggests the antiviral drug remdesivir may have a “modest but significant effect” on COVID-19 patient outcomes, including reducing the need for mechanical ventilation by about 50 percent.
While it claims to be an extension of the study solidarity testIn Canada, the disclaimer points out that one of the study’s authors, Conar O’Neill, is a member of the Gilead Sciences advisory board.
The US study – funded by the National Institute of Allergy and Infectious Diseases (NIAID) – named ACTT-1, showed that remdesivir was superior to a placebo (dummy pill) in reducing the time to recovery in adults who had been diagnosed with Covid-19. Was admitted to the hospital together.
Here too, six writers have been linked to Gilead in some way, such as receiving a grant or being employed by the company. However, the disclaimer clarifies that NIAID ultimately made all decisions.
New recipe coming soon. Ready for new experiments?
The data collected so far shows that the drug is “definitely not recommended” in mild and moderately ill patients who do not require oxygen support, nor are those on ventilators or ECMOs critical. The drug is recommended in sick ICU patients.
Sure, some patients may go home a few days earlier assuming that the drug shortens the days spent in hospitals, but we must ask whether the people, time, money and resources we invest to achieve the small benefits Is it really worth it?
It is useless for governments to invest in remdesivir based on the idea that it can help a small group of patients.
Now, after driving many of us for a lifetime, new studies suggest that this drug should be given either in home-settings or in day care (or OPD) centers of hospitals, shortly after the onset of symptoms. The US regulator, the US FDA, has approved the drug for high-risk Covid patients who are not sick enough to require hospitalization – somewhat similar to Merck’s molnupiravir or Pfizer’s paxlovid. In fact, the latter two are pills while remdesivir needs to be injected intravenously.
Overall, the drug – which is expensive, invasive and painful – has failed to affect significant outcomes for the patient – a reduction in deaths.
Another major reason for stopping the use of remdesivir is the possibility of it making a stronger strain of coronavirus.
Former ICMR Scientist Dr Raman Gangakhedkar I was once told during an interview that the administration of these antiviral treatments or plasma therapy would lead to the development of new drug-resistant mutations.
He told me that indiscriminate use of treatments, which have failed to prove effective in different stages of COVID-19, “could help the SARS CoV2 virus to mutate more and become stronger”.
In short, remdesivir has hardly lived up to the hype.
We must stop giving up on scientific reasoning, citing desperate times. It is a disease-detecting drug, not vice versa.
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