Gilead Sciences’ (NASDAQ:GILD) antiviral drug remdesivir has been praised by President Trump and the World Health Organization (WHO) as a possible treatment for the respiratory illness caused by coronavirus. The WHO even branded it the “most promising” therapy for COVID-19.
In one clinical trial at the University of Chicago Medicine, rapid recoveries in fever and respiratory symptoms were witnessed. All but two of the over 100 trial participants were discharged in under a week, as STAT reported Thursday.
Shares of Gilead Sciences and the broader market surged after the news.
Clinical trials consume time and resources before authorities can green light therapies. Despite the positive outcomes, the University of Chicago remdesivir trial cannot withstand scientific scrutiny. So far, its effectiveness in treating COVID-19 patients is only anecdotal.
The University of Chicago Medicine warned that using the results to draw conclusions is “premature and scientifically unsound.”
This anecdotal evidence isn’t isolated, though, which is adding to the growing hype around the drug.
Last week, the New England Journal of Medicine reported that another trial involving remdesivir had shown positive outcomes in some COVID-19 patients. This too was anecdotal evidence, as patients had been given the antiviral on a compassionate-use basis.
To determine the effectiveness of a drug, a proper clinical trial requires a control group. In the University of Chicago Medicine case, there was no placebo group involved in the trial.
Scientifically, it cannot be conclusively determined that remdesivir is responsible for the positive outcomes–even though it might very well be.
A placebo group would equally have determined whether side effects, if any, are as a result of COVID-19 or the therapy.
It’s worth mentioning that the results from the University of Chicago are only a snapshot, as there are other related trials happening elsewhere. A clearer picture will only emerge after the results from other clinical trials are in.
Besides the U.S., Gilead is conducting trials in Asia and Europe, while WHO is conducting a global trial. The French National Institute of Health and Medical Research is also running tests in Europe.
Before definite conclusions can be drawn, there is need for more data from randomized controlled studies around the world on the effectiveness of remdesivir.
It’s also worth remembering that remdesivir is just an investigational therapy without authorized used anywhere in the world. Even if it proves effective, there are still many unanswered questions, including the safety and efficacy of the drug, dosage, contraindications and so on.
Last week Gilead’s CEO Daniel O’Day urged caution , saying “we have some way to go.”
He’s right. The right call is to wait for the science to speak before popping the champagne.