Covid-19 drug rationed in the US is abundant in developing countries



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Meanwhile, Dr. Ahmedul Kabir in Bangladesh has a lot.

“We have no shortage of remdesivir in our hospitals,” said Kabir, professor of medicine at Dhaka Medical College. “Bangladesh is a third world country and we have enough numbers. It’s really surprising that America doesn’t have it. There should be a lot of remdes living there.”

CNN research on remdesivir finds that doctors in several developing countries report an ample supply of the drug, while American patients have faced shortages, despite the drug being manufactured by an American pharmaceutical company and developed with help. of US taxpayers’ money.

“The government funded it, and patients in hospitals like ours couldn’t get it,” said Patterson, chief of the infectious diseases division at the University of Texas Health Sciences Center at San Antonio.

At a press conference on Tuesday, doctors, advocates and a member of Congress criticized the Trump administration for failing to secure more remdesivir.

“Some whose suffering could be reduced and hospitalization shortened do not receive any relief due to Trump’s refusal to act,” Rep. Lloyd Doggett, a Democrat from Texas, said in a statement. “We could quickly expand the supply if Trump were to be late in leadership.”

In an email to CNN, a spokesperson for the US Department of Health and Human Services defended the president’s decisions to remdesivir.

“President Trump is putting American patients first and, through his leadership, secured more than 90 percent of Gilead’s commercial supply of this life-saving treatment,” the spokesperson wrote, referring to the pharmaceutical company of California which manufactures remdesivir.

‘Very close to falling off the cliff’

Data submitted by Gilead Sciences to the US Food and Drug Administration does not show that remdesivir saves lives. Rather, it shows that the drug shortens hospital stays, on average, from 15 to 11 days for severe Covid-19 patients. The FDA granted Gilead emergency use authorization for remdesivir in May based on that data.

The drug costs $ 2,340 for a five-day course of treatment and US hospitals don’t buy it outright as they do other drugs. Because there is not enough for everyone, HHS arranges for remdesivir to be shipped regularly to hospitals.

Gilead says it has enough for the demand, but doctors CNN interviewed say they don’t always have enough supply for all of their patients.

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Dr. Peter Chin-Hong, an infectious disease specialist at UCSF Health, said that several times he came close to not having enough for his Covid-19 patients.

“We have come very close to falling off the cliff,” he said.

Then Chin-Hong came up with the idea of ​​asking nearby hospitals to borrow some of his remdesivir, promising that he would return the favor when the next shipment arrived from his hospital.

“It’s like we are in a medieval market and trading chickens and goats,” he said.

A July survey of 131 hospitals by the American Society of Health System Pharmacists showed that nearly a third reported that they had not received enough remdesivir to treat all of their Covid-19 patients who met guidelines for the drug.

Pathways to Increase the Supply of Remdesivir in the US

Kabir, the doctor from Bangladesh, said his hospital has had a lot of remdesivir because they are buying generic versions of the drug.

Doctors in other developing countries said their hospitals are also using generics.

“We have enough remdesivir in our country,” said Dr. Bilal Aziz, assistant professor of medicine at King Edward Medical University in Lahore, Pakistan.

“We have no shortage,” said Dr. Endymion Tan, an infectious disease specialist at the Metropolitan Medical Center in Manila, Philippines.

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Several companies make generic remdesivir, including Beximco Pharmaceuticals in Bangladesh.

“We can produce more. We are currently producing around 80,000 vials per month, and we have the capacity and capacity to produce up to 150,000 per month,” said Rabbur Reza, Beximco’s chief operating officer.

But only Gilead can sell remdesivir in the US There are no generics and Gilead has no competition.

Christopher Morten, a patent law expert at New York University School of Law, said the Trump administration could change that if it wanted to.

Morten said the administration could enforce a law that allows the government to “open” patents so that Gilead can still benefit from the drug, but that other companies could make generic versions of it.

“The US government always has the power to, to put it colloquially, break patents when those patents get in the way of competition, and Gilead is guaranteed fair compensation under the same law, so Gilead would still make a lot of money, “said Morten, deputy director of the NYU Law Clinic for Technology Policy and Law.

He said that in the case of remdesivir, he believes the government also has a second option.

The United States can legitimately claim to be the co-owner of the remdesivir patents, as government funding and expertise was used to do so, according to a co-authored article by Morten and James Krellenstein, co-founder of COVID Working Group NYC.

“I think the US government co-invented and is a co-owner of the major remdesivir patents,” Morten said.

Gilead disagrees, as does HHS.

US Government Supply of Covid-19 Drug Remdesivir Runs Out by End of Month

“There are many patents on remdesivir, and the US government has participated in the investigation of some of these patents. The US government is not listed as a co-inventor in any of the current remdesivir patents,” according to the statement. of the HHS. spokesman.

Now, the US Government Accountability Office is investigating that very problem.

A GAO investigation

In July, two Democratic lawmakers, Sen. Debbie Stabenow of Michigan and Carolyn Maloney of New York, asked the Government Accountability Office to investigate the discovery and development of remdesivir.

“Remdesivir was developed with an estimated $ 70 million in federal funding, and Gilead relied on key scientific contributions from government scientists,” the congresswomen wrote.

More evidence that remdesivir helps some coronavirus patients

GAO expects to have a report by the end of the year, according to Candice Wright, acting director of GAO’s Science, Technology Assessment and Analytics division.

He said his team is speaking with officials from HHS and the Department of Defense, which worked with Gilead on remdesivir.

“We know there were federal contributions based on peer-reviewed articles,” Wright said.

On its website, Gilead details the work the company has done on remdesivir since 2014 with the US Centers for Disease Control and Prevention, the US Army Infectious Diseases Medical Research Institute. And the National Institutes of Health.

In an email sent to CNN, Gilead spokesman Chris Ridley emphasized the role that Gilead, not the government, played in developing the drug.

“The research that led to remdesivir began more than a decade ago. Gilead researchers invented remdesivir, identified its broad-spectrum antiviral activity, optimized the product formulation, and expanded the manufacturing process. Although government funding was used to characterize still plus the profile of remdesivir after its initial discovery, this did not result in the creation of the underlying intellectual property invented by Gilead, “wrote Ridley.

Ridley also said that government grants totaling about $ 76 million were awarded to academics who collaborated with Gilead, “a portion of which was used to support his work with Gilead on remdesivir.”

“Gilead has invested significantly more in remdesivir research and development than public sources,” he added.

But Morten, the NYU attorney, said it’s clear to him that Americans are paying twice for remdesivir: once to help develop it and a second to buy it for the treatment of Covid-19.

“I think this is concerning, it is a very good deal for Gilead,” he said.

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