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Bloomberg Law – First Look at Gilead Drug Virus Response to Open Data Floodgates

Bloomberg Law – First Look at Gilead Drug Virus Response to Open Data Floodgates

The first look at how well Gilead’s Ebola drug treats Covid-19 patients in an NIH clinical trial should come in a matter of weeks, the agency’s head said Monday.


If available, that initial analysis would come a little more than two months after the trial began. It’s also the first wave in a deluge of data the National Institutes of Health and the Food and Drug Administration will need to assess as they aggressively shepherd new medicines to treat the viral outbreak.


The data won’t just come from closely controlled clinical trials like for Gilead’s remdesivir but also from information gleaned from doctors prescribing hydroxychloroquine off-label to combat Covid-19 infections.


“We’ve got this urgency to learn what we can as soon as we can” from patients who are receiving care right now, FDA Principal Deputy Commissioner Amy Abernethy said during a Duke-Margolis webinar. She acknowledged that approach “takes us out of comfort zone.”

Ebola Drug Most Promising

Remdesivir, originally developed to combat Ebola, is one of 20 antivirals and more than 100 Covid-19 treatments in the research pipeline, according to a vaccine and treatment tracker by the think tank Faster Cures. In development since 2014, it’s the one considered the most advanced in clinical development. Gilead has said it expects data from a separate remdesivir trial in China this month.


Gilead Sciences Inc. also has offered remdesivir as part of an expanded access protocol, allowing patients access to the drug in a way that will also allow the company to collect data. Scott Gottlieb, a former FDA commissioner who’s been informally advising the White House, said this approach could serve as a model for conducting trials in future public health outbreaks.


“In some ways it’s optimal,” Gottlieb said during the Duke-Margolis event. “You have the rigorous trial underway to definitely answer the data question while you’re collecting incremental information in open-label studies that are being run alongside that and not impinging your ability to bring that randomized trial to completion.”


An open-label study is when both the health-care providers and the patients are aware they’re getting the treatment, whereas randomized controlled trials are blinded studies to eliminate bias.


Even if remdesivir proves effective against Covid-19, NIH Director Francis Collins said during the Duke-Margolis webinar that it won’t be a silver bullet and other therapeutics will still need to come to the market.


“If HIV takes more than one drug, I’m not sure why we think coronavirus SARS-Cov-2 will be cured with one,” Collins said. “We may very well may combination therapies.”


Developing treatments will be vital for preventing a second wave of infections after the hot and humid weather of summer months tamp down the virus, allowing schools and business travel to resume, Gottlieb said.


“It’s incumbent upon regulators around the world to focus on the products that could be available and try to pull them through development,” he said.

Covid-19 Accelerator

A new initiative called the COVID-19 Evidence Accelerator aims to pool ongoing data sources from government and academic researchers, health systems, and private companies to solutions for Covid-19. With so much information becoming available rapidly, the accelerator will aid data sharing and establish some uniformity around data collection.


“The goal in putting this together was really to try and unify numerous different, disparate efforts that are already underway,” Jeff Allen, president of Friends of Cancer Research, said in an interview Monday. Friends established the accelerator along with the Reagan-Udall Foundation, a nonprofit for FDA public-private partnerships.


The accelerator involves 30 organizations, with 10 or 20 more potentially coming on board. It builds on ongoing efforts to maximize real-world data, or patient-generated data from electronic health records and other data collected outside a clinical trial. Participating researchers will hold weekly meetings to present and critically discuss findings from different data sources.…