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            Fast-tracked drug tied to Alabama is ready to battle COVID, but questions remain

            Remdesivir coronavirus drug

            Allyson Curry, the inventory/buyer with the department of Pharmacy at Penn State Health Milton S. Hershey Medical Center, holds a bottle of remdesivir in the pharmacy on Wednesday, May 20, 2020.

            The FDA approved a COVID drug tied to Alabama but worries remain about its effectiveness.

            Researchers at an Alabama university played key roles developing remdesivir, the first FDA-approved treatment for COVID-19, but the drug has shown mixed results in clinical trials and raised concerns about private profit from publicly funded research.

            Last week, the U.S. Food and Drug Administration approved Veklury, also known as remdesivir, an anti-viral drug owned by California drug company Gilead Sciences for treatment of coronavirus. Hospitals have been using the drug since May, when the FDA issued an emergency use authorization. It’s the first treatment officially approved for treatment of coronavirus.

            But not everyone is excited about its potential. Dr. Michael Saag, an infectious disease specialist at the University of Alabama at Birmingham mentioned the drug in a recent episode of the podcast Outbreak Alabama.

            “Then we got a drug called remdesivir in the first part of May, and it works but not great,” Saag said.

            Remdsivir’s approval comes on the heels of conflicting study results, which find no proven effect on the rate of death.

            But it may shorten the course of the infection for people with symptoms. One study funded by the National Institute of Allergy and Infectious Diseases (NIAID) found that patients who received remdesivir had shorter hospital stays than those who received a placebo. However, another study overseen by the World Health Organization found no benefit.

            Gilead, the drug company, released a statement questioning the results of the World Health Organization study.

            “We are concerned that the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design,” the drug company said.

            Researchers at UAB participated in the study that found some effect on length of hospital stays. Dr. Nathan Erdmann, a researcher and professor in the University of Alabama at Birmingham’s Department of Infectious Diseases, said the NIAID study compared people who received remdesivir with those who did not. Even he and his team did not know which patients received the treatment and which ones received the placebo. Such studies are the “gold standard” for scientific research.

            “It’s not so powerful that people can just jump out of bed two days after they receive it,” Erdmann said. “But It’s a good drug, it seems to help.”

            Remdesivir can only be administered through an IV to patients in the hospital, Erdmann said. For that reason, it has only been used in the most critically ill patients.

            The study from the World Health Organization did not sort patients into treatment and placebo groups. Instead, it sought to measure the real-world effect of treatments in hospital settings in a large number of people. That trial examined the effects of four drugs, including remdesivir, and found “little to no benefit.”

            Erdmann said the NIAID study only looked at average length of hospital stay, which was shorter in remdesivir patients. Although the study didn’t measure death rates, he said the results indicated an advantage for treated patients.

            “The way the drug works is that it seems to interrupt the progression of the disease so patients can start getting better,” Erdmann said.

            UAB’s involvement in the development of remdesivir started long before this year’s NIAID study. The university runs the Antiviral Drug Discovery and Development Center, which has played a key role in remdesivir research since it was founded in 2014.

            First identified in 2014 as a potential treatment for Ebola, remdesivir’s development benefitted from years of federal support, said Kathryn Ardizzone, an attorney at Knowledge Ecology International.

            “Gilead had a library of compounds that I don’t think were being put to any use,” Ardizzone said. “The government helped screen, refine and test that compound for effectiveness. All of that research that was funded by the government.”

            Knowledge Ecology International, a non-profit organization that explores drug patents and public health, published a history of the drug’s development earlier this year. The drug was discovered by federal scientists in a library of potential antivirals owned by Gilead. The company made its name developing treatments for viral infections such as HIV and hepatitis c.

            Since the beginning of the pandemic, the government’s investment in drug development has been “on steroids,” Ardizzone said. But private companies like Gilead are already profiting from research funded by the federal government.

            “There’s this issue of the government putting a lot of money into research and development and how that’s privatized and whether or not the practices on licensing and pricing are in the interest of the general public,” said James Love, director of Knowledge Ecology International.

            According to an announcement released Wednesday, Gilead earned $873 million in sales of remdesivir during the third quarter of 2020. Gilead priced the drug at $2,340 for a five-day treatment course.

            Remdesivir proved less effective as a treatment of Ebola than other compounds. Researchers decided to test it against deadly coronaviruses SARS and MERS. Much of that research was coordinated in Alabama by UAB’s Drug Discovery and Development Center, under the direction of Dr. Richard Whitley. Whitley also serves as a board member for Gilead Sciences.

            When the pandemic began, remdesivir had been shown to be safe for use in humans and promising as a treatment in cornaviruses animal studies.

            Usually drug studies take years to plan and complete, Erdmann said. It took less than a year to identify remdesivir as a potential COVID-19 treatment, test it and get FDA approval.

            “The first person enrolled in the study on February 21, emergency use authorization happened on May 1 and then we got approval in October,” Erdmann said. “That’s incredibly fast.”

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