A frequent refrain we hear on the news these days is whether there are medicines and other potential solutions to help Americans in our fight against the novel coronavirus (COVID-19).
On Saturday, April 4, 2020, Daniel O’Day, the Chairman and CEO of Gilead Sciences, Inc., posted an online update on what Gilead is doing to help in the fight against COVID-19. He noted that Gilead has been working in tandem with regulatory authorities to “establish additional expanded access programs for remdesivir, our investigational medicine for COVID-19.”
According to O’Day, these expanded access programs allow hospitals – or individual physicians – to apply to use remdesivir on an emergency basis for multiple severely ill patients at a time. These patients are those who cannot take part in clinical trials. In addition to the expanded access programs for severely ill patients, Gilead is providing remdesivir “on an individual compassionate use basis for children and pregnant women” and that more than 1,700 patients have been treated through those programs.
While Gilead does acknowledge remdesivir is currently an investigational medicine and has not been approved by regulatory authorities anywhere, there are multiple clinical trials currently underway for remdesivir, “involving thousands of patients with COVID-19 across the world.”
Gilead has ramped up production and “significantly increased our available supply of remdesivir using the inventory of active pharmaceutical ingredients we already had on hand.” Currently, their existing supply “amounts to 1.5 million individual doses,” which depending on the optimal treatment duration, “could equate to well over 140,000 treatment courses for patients.”
Gilead is willing to “provide the entirety of this existing supply at no cost, to treat patients with the most severe symptoms of COVID-19. The 1.5 million individual doses are available for compassionate use, expanded access and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations. These doses are for treating patients with severe symptoms, through daily intravenous infusions in a hospital setting. Having a potential treatment in our hands comes with significant responsibility. Providing our existing supplies at no charge is the right thing to do, to facilitate access to patients as quickly as possible and in recognition of the public emergency posed by this pandemic.”
This could be a game changer.
Scott Gottlieb Op Ed
On Sunday, April 5, 2020, former United States Food and Drug Commissioner Dr. Scott Gottlieb wrote an op-ed in the Wall Street Journal. In it, he noted that he doesn’t believe we will be able to “beat” COVID-19 absent a technological breakthrough. He mentioned “aggressive surveillance and screening” which may be helpful to warn of new clusters or the possibility of a vaccine against the virus (but that there isn’t enough time for one to come out this year), and that the “best near-term hope” is an “effective therapeutic drug.”
Dr. Gottlieb went on to note two paths that would help move a drug to market, and that both “could be available soon if government and private industry do things right.” The first approach would be with an antiviral drug, such as remdesivir, that blocks “the mechanisms that viruses use to replicate.” The second approach would be with an antibody drug, which mimic the function of immune cells and can be used to fight an infection and reduce the risk of contracting the disease.
A medication that significantly reduced the likelihood of becoming severely ill with coronavirus may “restore at least $1 trillion in economic activity,” according to the article, with credit for that figure being given to Kevin Warsh, a former Federal Reserve governor.