US Congressman called for the Securities and Exchange Commission on Friday, April 17, to investigate the newly leaked video that included a conference between physicians at the University of Chicago who were talking about experimental drug Remdesivir's positive effect on Coronavirus patients.
Texas Democrat Lloyd Doggett, chair of the House Ways and Means Health Subcommittee said that the leak was "so significant" at the time when the world is desperately looking for COVID-19 cure.
Remdesivir test
Researchers at the University of Chicago are helping test an antiviral drug made by Gilead Sciences, remdesivir in Coronavirus patients. Dr Kathleen Mullane, an infectious disease specialist at the university is currently leading the clinical trial funded by Gilead.
In the video conference, obtained by STAT News, a health news website, it was revealed how the patients are responding to the medication. It should be noted that the drug, which was actually created to treat Ebola, has shown early promise in treating some Chinese COVID-19 patients and is proven safe for humans. In a press conference in China, Bruce Aylward, a WHO official said, "There's only one drug right now that we think may have real efficacy. And that's remdesivir." As per early reports among all the drugs claimed to be working against the Coronavirus, remdesivir, developed by Gilead sciences could be the closest to commercial launch.
In the recent video, which was released on Thursday, Mullane said, "The best news is that most of our patients have already been discharged, which is great. We've only had two patients perish."
New questions raised by congressman
The 73-year-old Doggett said that "providing information that's designed to impact the stock market is not something that is permitted under federal securities law." He also mentioned that from where the video was leaked is also not clear and "That's why we need a thorough SEC investigation."
A spokesperson from Gilead, Chris Ridley said that the makers of remdesivir was not involved in the leak. He clearly stated that "Gilead had nothing to do with the information sourced by STAT from an internal recording out of the University of Chicago hospital."
University of Chicago remdesivir trial
There are two trials currently running in the University of Chicago which are paid for by Gilead. While one of the trails include COVID-19 patients with severe symptoms, the other group includes patients with moderate symptoms.
As per the video, Mullane said, "Most of our patients are severe and most of them are leaving at six days, so that tells us the duration of therapy doesn't have to be 10 days."
However, the trial does not include what is known as the control group, so it will be difficult to confirm whether the drug is actually helping COVID-patients or not because some participants do not receive the medication in a control group to determine whether it is the drug that is improving or affecting their health condition.
But there is a separate remdesivir trial sponsored by the National Institute of Allergy and Infectious Diseases which includes a control group. Dr Kathryn Hibbert, director of the medical intensive care unit at Massachusetts General Hospital who is participating in the NIAID trial said, "We have seen patients who've received remdesivir who've had remarkable recoveries and we've seen patients who've not received remdesivir and had remarkable recoveries."
Earlier, Gilead said, "We understand the urgent need for a COVID-19 treatment and the resulting interest in data on our investigational antiviral drug Remdesivir. The totality of the data needs to be analyzed in order to draw any conclusions from the trial. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of Remdesivir as a treatment for COVID-19."
Hibbert told CNN that doctors should be extremely cautious about "responding too enthusiastically" to the early data. In addition, she added that "over decades, we've established that critical review of clinical trials is the best way to determine if the data is strong enough to inform clinical decisions."
