EU regulator reviews COVID drug safety

India’s fatality number likely an undercount: experts

LONDON, Oct 4, (AP): The European Medicines Agency says it has started a safety review after some patients taking the coronavirus drug remdesivir reported serious kidney problems.

In a statement on Friday, the EU regulator said it isn’t clear whether remdesivir was causing the “acute kidney injury”, but that the issue “warrants further investigation”.

Remdesivir was given a conditional marketing authorization by the EMA on July 3 and can be used to treat people older than age 12 with severe COVID-19 and pneumonia who require oxygen treatment. The approval for the drug was fast-tracked with the understanding that more evidence would be submitted after a license was granted.

“The benefits to these severely ill patients outweigh the risks of making the medicine available despite having less complete data than normally expected,” the EMA said.

Remdesivir is one of the few licensed treatments for the coronavirus, in addition to the generic steroid dexamethasone. In July, health experts criticized the United States for buying up a significant portion of the drug, made by Gilead Sciences.

The European Medicines Agency said the potential problem of kidney toxicity caused by remdesivir was evaluated when the conditional approval was given but that analysis was mainly based on animal studies. It noted that kidney injuries can be caused by other factors, including diabetes and the coronavirus itself.

The regulator said recommendations for the use of remdesivir remain unchanged; doctors are already advised to monitor patients for kidney complications prior to starting treatment and not to use the drug in patients with known kidney problems.

Monitoring

The agency said “enhanced safety monitoring” is in place to detect potentially worrying and unexpected side effects from remdesivir through monthly safety reports.

Early studies testing remdesivir in patients hospitalized with COVID-19 found that those who received the treatment recovered quicker than those who didn’t.

On Thursday, the EMA said it had begun the process of potentially fasttracking approval for an experimental COVID-19 vaccine developed by Oxford University and AstraZeneca.

Meanwhile, India passed a grim milestone in its fight against the coronavirus on Saturday, with health authorities saying the country has recorded more than 100,000 virus-related deaths since the pandemic began.

The announcement from the Health Ministry means that nearly 10% of the more than 1 million people to die globally in the pandemic have done so in India, behind only the United States and Brazil. India has seen more than 6.4 million total confirmed infections, recording more than 79,000 new cases in the past 24 hours.

Prime Minister Narendra Modi and his government are facing criticism for failing to stop the march of the virus, which in September hit India harder than any other nation in the world. Almost 41% of India’s total infections and 34% of COVID-19 deaths were reported in September alone, with an average of nearly 1,100 Indians dying every day from the virus.

As in many countries, Modi and his government have struggled with how to balance virus restrictions with the the need to boost a contracting economy in which millions are newly jobless.

Even as the nation reaches 100,000 confirmed deaths, experts say that number is likely still an undercount. They say many COVID-19 deaths may have been attributed to other causes, especially in the early days of the pandemic when testing was abysmally low for a country with a population of 1.4 billion.

Damage

“India’s fatalities numbers don’t reflect the true extent of the damage the virus has done,” said Dr T. Jacob John, a retired virologist.

India’s poor track record to register mortality data even before the pandemic has further amplified questions over the actual death toll. On Wednesday, US President Donald Trump, during the first presidential debate, suggested India was under-reporting deaths, though he provided no evidence.

India’s first COVID-19 death was reported on March 12. Over the next five months, the disease killed 50,000 people. It took just 45 more days for that number to double, underscoring the severity of a pandemic that has swamped intensive care units and morgues and also contributed to the deaths of medical professionals.

The Indian Medical Association on Friday said at least 500 doctors have died of the coronavirus, adding the toll could be far higher. The association last month accused the government of “indifference” after it said there was no complete data on the number of frontline health care workers who had contracted the coronavirus and died.

Among the lives taken was 58-yearold Abdul Quddoos of Hapur, Uttar Pradesh, who died May 28. He was a general physician, a husband and a father of three.

On Saturday, his son, 32-year-old Mohd Danish, stood next to his grave in New Delhi’s largest Muslim cemetery and spread flower petals on it.

“I feel patients are not being taken care of in the hospitals,” Danish said.

Meters away, Mohammad Shameem, a gravedigger who now also oversees the burials, helped lower another body in a grave with ropes. As grieving relatives looked on, a visibly tired Shameem described the extent of the virus toll.

“There is very little space is left now at the burial ground,” said Shameem. “We are going to increase the space for the fourth time.”

The virus has exacted an especially vicious toll on southern Maharashtra, one of India’s largest and richest states. It has recorded nearly 1.3 million cases including more than 37,000 deaths. In neighboring Karnataka, the fatalities stand at nearly 9,000.

Comprise

The two states comprise almost 45% of total COVID-19 deaths in the country.

Other states like Delhi, West Bengal, Uttar Pradesh and Andhra Pradesh have had more than 5,000 deaths each.

Overall numbers also show that India’s urban districts have so far accounted for nearly 80% of the death toll, but health experts have warned of a “slow burn” surge in the country’s vast hinterlands.

“India has an inadequate health system, which is lopsided and unjustly distributed. The virus exacerbated these problems in India’s cities and the rural areas will soon face the same,” John said.

Even as the numbers keep rising, India’s senior health officials have used the COVID-19 fatality rate of 1.56%, which is nearly half of the global one, as evidence of its success in fighting the pandemic and a basis for relaxing restrictions and reopening the economy.

India also has the highest number of recovered patients in the world. More than 5.4 million people have recovered, a rate of more than 83% of those infected, according to the Health Ministry.

With the second-most reported infections in the world, the crisis India faces stands in stark contrast to Modi’s claim before the March lockdown that “the battle against coronavirus will take 21 days”.

Public health experts say a disorderly lockdown, which led millions of migrant workers to flee from cities to villages, possibly carrying the virus with them, further complicated the fight against the virus.

Still, India is preparing to reopen cinemas and entertainment parks with limited capacity beginning Oct 15, in an effort to revive the economy.

Health experts warn the move has the potential for the virus to spread during the upcoming religious festival and winter season.