QUICK READ: STAT News post entitled “Early peek at data on Gilead drug suggests patients are responding to treatment” was irresponsible and had led to investors gambling on a drug that has no substantial clinical data behind it. Both Gilead and the hospital urged caution. “Information from an internal forum for research colleagues concerning work in progress was released without authorization,” said University of Chicago Medicine. “Drawing any conclusions at this point is premature and scientifically unsound.”
Wall Street shares are on track for a higher opening on Friday after a report suggested a drug developed by Gilead Sciences had shown positive results in a clinical trial, giving investors hope that a treatment could ease the pandemic and open up the global economy. However In a statement after its shares leapt, Gilead urged caution. “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,” it said.
“ 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. We expect the data from our phase 3 study in patients with severe Covid-19 infection to be available at the end of this month, and additional data from other studies to become available in May.”
Jefferies equity analysts said the excitement was “overdone in the near term”, and highlighted that the findings do not come from the later stages of clinical research. “We appreciate that the broader market is in a risk-on and glass-half-full environment and investors are looking for a good story,” the analysts said.
What remains uncertain?
Almost everything. Even if the positive findings from Chicago are confirmed when they are officially released, probably later this month, skeptics will point out that it is what researchers call an “open label trial” in which everyone knows that remdesivir is being infused. The progression of Covid-19 is variable and unpredictable — and the positive results might have been good luck.
As one analyst said “what do you mean encouraging? Doing a study without virology or planning for it? It’s malpractice! Read the elegant virology report in the NEJM. The symptoms did not get better as the virology showed no changes with the combo. Get rid of the virus, symptoms will improve”.
I am very disappointed that STAT news would release such a story, but at the same time I believe Gilead’s response was appropriate. Investors could give a damn about patients they are gambling and in their zeal to reap rewards they are spreading false hope.
Originally published at https://worldofdtcmarketing.com on April 17, 2020.