"There's now enough data to support consideration of access under an emergency use authorization by FDA." "The data from NIAID [National Institute of Allergy and Infectious Diseases] study should push this firmly over the line." Scott Gottlieb, former commissioner, U.S.Food and Drug Administration
"The
study demonstrates the potential for some patients to be treated with a
five-day regimen, which could significantly expand the number of
patients who could be treated." Chief Medical Officer Merdad Parsey, Gilead Sciences Inc.
"As part of the FDA's commitment to expediting the development and
availability of potential COVID-19 treatments, the agency has been
engaged in ... discussions with Gilead Sciences regarding making
remdesivir available to patients as quickly as possible, as
appropriate." Michael Felberbaum, spokesman, U.S. Food and Drug Administration
"The data shows that remdesivir has a clear-cut, significant, positive
effect in diminishing the time to recovery." "Although a 31% improvement doesn't seem like a knockout 100%, it is
very important proof of concept." "What it has
proven is that a drug can block this virus." "[But] whenever you have clear-cut evidence that a drug works, you have an
ethical obligation to immediately let the people in the placebo group
know so that they can have access." Dr. Anthony Fauci, immunologist, director, National Institute of Allergy and Infectious Diseases
"[The drug is] not the end of the story [when it comes to treatments for Covid-19]."
"We have work to do. We are looking for other therapies. This trial is going to continue."
"Four
days [fewer] in a hospital is, for me as a clinician -- as a clinical
practitioner -- it is not only significant but very meaningful. [This would matter] to all my patients and even to myself,
if I would be in the same situation."
Dr.Andre Kalil, principal investigator behind the clinical trial
The experimental
antiviral drug remdesivir, according to results out of Gilead Sciences'
Inc.Bottles of remdesivir in a hospital for Covid-19 patients in Wuhan,
China.
FeatureChina via AP
The experimental antiviral drug remdesivir, according to conclusions
reached through a clinical trial launched by Gilead Sciences Inc.,
helped to improve outcomes for patients diagnosed with COVID-19, the
data indicating that the drug worked more efficiently when used earlier
in the course of the illness that has caused a global pandemic,
infecting over a million people world-wide and leading to countless
deaths.
Several studies had previously been released whose outcomes presented a
contradictory picture of the drug's effectiveness. There were two
clinical trials linked to Gilead; a study conducted by the NIAID met its
major goal helping patients suffering a severity range of symptoms from
the disease caused by the novel coronavirus. That trial compared how
patients receiving remdesivir fared in comparison to others given a
placebo, expected to definitively demonstrate any benefits provided by
the drug.
Gilead announced that 62 percent of patients given early treatment with
remdesivir were able to be discharged early from hospital, as opposed to
40 percent of patients who were given the drug treatment later in the
course of the infection. The trial, with 397 patients taking part,
evaluated safety and efficacy related to the five-day regimen. Still,
there have been doubts expressed that it may not present a significant
benefit.
The Lancet
medical journal published results of a trial conducted in China which
reached the conclusion that remdesivir had failed to improve the
condition of patients. Gilead expressed its opinion that the Chinese
trial was inconclusive merely as a result of the study being terminated
too early. The result of the Chinese trial had been inadvertently
released by the WHO's emergencies program. Dr.Mike Ryan who heads the
WHO program declined comment.
This represents a general opinion site for its author. It also offers a space for the author to record her experiences and perceptions,both personal and public. This is rendered obvious by the content contained in the blog, but the space is here inviting me to write. And so I do.
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