A Saint Michael's Medical Center employee in the intensive care unit
of a patient with COVID-19 on a respirator.
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NEWARK, NJ -- One of the most promising treatments for COVID-19 is being made available
through an expanded access program at Prime Healthcare’s Saint Michael’s
Medical Center in Newark.
Remdesivir, considered by the World Health Organization to be the most
promising drugs to treat COVID-19, was developed by Gilead Sciences to
treat Ebola. The antiviral drug is effective against two other coronaviruses
that cause deadly respiratory diseases – SARS and MERS – and
is in five large clinical trials for the treatment of COVID-19.
Saint Michael’s is one of only a handful of sites in the world to
participate in the expanded access program, which will allow the hospital
to administer remdesivir to critically ill patients who are on ventilators.
The hospital has been a leader in clinical infectious disease research
and has worked with Gilead since the pharmaceutical company was founded in 1987.
There is currently no treatment approved for COVID-19, a disease which
has infected more than 1.2 million worldwide and resulted in nearly 70,000 deaths.
Saint Michael’s is located in the New York metropolitan area, which
has become ground zero for COVID-19 infection in the United States. In
the last week, Saint Michael’s has seen a spike in patients with
the disease. Currently nearly every bed in the hospital is filled with
patients who have tested positive for the virus. New Jersey has the second
most cases in the United States, behind New York.
“The trial use of remdesivir is just one way Prime Healthcare hospitals
are helping in the fight against this unprecedented pandemic,” said
David Silverman, PharmD, vice president of pharmacy services for Prime
Healthcare. “We are currently exploring options for expanded access
programs of the drug.”
Prime Healthcare, a national health system with 45 hospitals in 14 states,
purchased the 358-bed hospital in the heart of Newark’s business
and university community in 2016.
“Prime Healthcare’s mission of saving hospitals to save lives
has never been more important and we have been working tirelessly to provide
resources to our patients and care givers that will transform care, such
as access to the most promising emerging treatments,” said Kavitha
Bhatia, MD, MMM, Prime Healthcare’s Chief Medical Officer of Strategy.
James Fallon, the director of clinical research at Saint Michael’s,
said remdesivir was previously available on a limited basis through a
“compassionate use” program for individual patients who were
too ill to participate in a clinical trial. About 1,000 people were participating
in the compassionate use program.
Gilead Sciences Chairman and CEO Daniel O’Day wrote in an open letter
published in March week that compassionate use typically works well when
there are a limited number of requests for the drug.
“But the system cannot support and process the overwhelming number
of applications we have seen with COVID-19,” O’Day wrote.
“There is nothing typical about this crisis.”
With expanded access, hospitals or physicians can apply for emergency use
of remdesivir for multiple severely ill patients at a time. “This
approach will ultimately accelerate emergency access for more people,”
Dr. Jihad Slim, who heads the Department of Infectious Diseases at Saint
Michael’s, has been involved in clinical research at the hospital
since the late 1980s. Dr. Slim worked with Gilead on drug treatments for
HIV/AIDS and played a leading role in the fight against HIV during the
“Just as we played an important role in helping to find medications
for AIDS, our Infectious Disease Department is once again ready to take
on that role as we fight against COVID-19,” Dr. Slim said. “If
remdesivir works the way we all hope it will, it will be a game changer.”