Experts fear unnecessary push of remdesivir, hydroxychloroquine

Pharmacologists and virologists have spoken against ‘unnecessary enthusiasm’ about remdesivir and hydroxychloroquine, two drugs now under examination for COVID-19 treatment in the USA, as several companies in Bangladesh are set to produce the medicines.

They said that the drugs’ success in treating COVID-19 was yet to be proved and that these drugs should not be ‘promoted’.

There are several severe side effects of these drugs and using them might bring about severe consequences like organ failure, they said.

Remdesivir is a broad-spectrum antiviral medication developed by the US biopharmaceutical company Gilead Sciences.

 

It is under tests as a specific treatment for COVID-19 and has been authorised for ‘emergency use’ in the USA and has been approved for use in Japan for people with severe symptoms.

The drug is being used for only who are in critical state in those countries under strict regulation as it has many side effects.

The most common adverse effects in studies of remdesivir for COVID-19 include respiratory failure and organ impairment, including low albumin, low potassium, low count of red blood cells, low count of platelets that help with clotting, and yellow discoloration of the skin, according to the experts.

Other reported side effects include gastrointestinal distress, elevated transaminase levels in the blood (liver enzymes), and infusion-site reactions, they said.

Additionally, hydroxychloroquine, a medicine for malaria patients and rheumatoid arthritis, has also showed no proof to have cured COVID-19.

Hydroxychloroquine’s side effects include blindness, reduced heart rates and blood pressure, chest pain, headache, muscular weakness, retinal damage and sudden fall in blood sugar level.

Bangabandhu Sheikh Mujib Medical University pharmacology professor Sayedur Rahman pointed out that when there was no proven success of these drugs, the mass campaign about these drugs was unacceptable.

There is no strong evidence that these drugs are effective for treating COVID-19, but we are going for its production… the mass campaign smacks of ulterior motive, he said.

Sayedur suspects that these costly medicines would be ‘pushed’ for use in the country by unholy quarters. ‘The media campaign for its use is part of such unnecessary “push”,’ he added.

‘These medicines should not be sold,’ he said, adding, ‘We have to wait for  scientifically strong evidence for its use.’

BSMMU virology chairman Saif Ullah Munshi said that hydroxychloroquine should not be discussed as no studies were found that it worked against COVID-19.

For remdesivir, he said, the medicine was still under trial by the National Institute of Allergy and Infectious Diseases of USA and so far no significant results emerged supporting its use.

‘Their trial findings of using remdesivir are not statistically significant,’ he said.

‘We should read the result carefully,’ he said.

‘Though we are in need of such holy grail, we have to think about the cost-benefit of using these  medicines for the patients in the lower, middle-income countries like Bangladesh, when the result is not that significant,’ he said.

‘We have to know before we start using it, if it will really bring any benefit,’ he added.

USA’s National Institutes of Health on Friday said on its website that a randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019 (COVID-19) has begun.

The trial is now enrolling hospitalised adults with COVID-19 in the United States. The trial is expected to open at approximately 100 USA and international sites.

Investigators currently anticipate enrolling more than 1,000 participants. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is sponsoring the trial, it said.

The clinical trial is the next iteration of NIAID’s Adaptive COVID-19 Treatment Trial, which began on February 21 to evaluate remdesivir, an investigational broad-spectrum antiviral treatment developed by Gilead Sciences, Inc.

‘More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report,’ said National Institutes of Health.

A study published by The New England Journal of Medicine on Thursday on the use of hydroxychloroquine said that in the analysis [under the study] involving a large sample of consecutive patients who had been hospitalised with COVID-19, the risk of intubation or death was not significantly higher or lower among patients who received hydroxychloroquine than among those who did not received it.

The study done on patients at a large hospital in New York was also sponsored by the USA’s National Institutes of Health.

Directorate General of Drug Administration spokesperson Ruhul Amin said that eight companies — Beximco, Skayf, Square, Healthcare, Becon, Opsonin, Popular and Incepta — were given the nod to produce remdesivir as an anti-viral medicine not as a COVID-19 medicine.

‘And those medicine should be passed through our drug testing lab,’ he said.

The marketing authorisation certificates were also yet to be issued, he added.

On giving approval for production of the drug when there was no significant proof of its success was found, Ruhul, also director of DGDA, said that it was part of the country’s preparation for treatment of COVID-19.

‘We will use the medicine if the global scientific studies find it effective,’ he said.

Bangladesh Association of Pharmaceutical Industries general secretary SM Shafiuzzaman said that they went for production of the medicines as a ‘hope against hope’.

‘We don’t want to stay behind production of any medicine which is being proposed as a possible solution when there is no other medicines available,’ he said.

News Courtesy: www.newagebd.net