Oracle Corp. has built and donated to the U.S. government a web portal and online platform aimed at crowdsourcing information about the experimental drugs being used to treat the new coronavirus, the company and Trump administration officials said.
Health and Human Services Secretary Alex Azar urged healthcare providers April 3 to register on the site and report their outcomes information about the therapies they are using for patients with COVID-19, the disease caused by the novel coronavirus.
Oracle said its system will allow healthcare providers and agencies "a fast way to study COVID-19 patient outcomes in aggregate."
But registration is voluntary, so the crowdsourced data may not provide a full view of any experimental drug's efficacy and safety issues.
The crowdsourcing portal is hosted on Oracle's website, so it is unclear what role HHS will play in overseeing the collection and protection of the data.
There are no drugs approved by the U.S. Food and Drug Administration to treat COVID-19, though there are a number of experimental therapies in clinical testing.
Last week, the FDA created a special emergency program to expedite therapies for the disease.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci first talked about the new online system last month, saying it would have the capability to collect information about the experimental use of chloroquine and hydroxychloroquine in COVID-19 patients.
The two drugs are approved in the U.S. for malaria, lupus and rheumatoid arthritis, but the medicines have been linked to a number of serious side effects, including suicide.
President Donald Trump has repeatedly touted hydroxychloroquine and chloroquine as coronavirus treatments and has incorrectly said the FDA granted approval to the drugs.
The FDA on March 28 issued an emergency use authorization for supplies of the two drugs that have been donated to the U.S. Strategic National Stockpile use in hospitalized patients with COVID-19.
The data for hydroxychloroquine and chloroquine "are really just at best suggestive," Fauci said April 5 on CBS' "Face the Nation." "In terms of science, I don't think we could definitively say it works."
On "Fox & Friends" on April 3, Fauci pushed back on the results of a physician survey that found 37% said they felt hydroxychloroquine was an effective treatment for COVID-19.
President Donald Trump and NIAID Director Anthony Fauci
"We don't operate on how you feel," Fauci said. "We operate on what evidence is, what data is."
No one should be making a "majestic leap" from a suggestion to assuming hydroxychloroquine is a "knock out drug," he said.
At an April 5 briefing, Trump again promoted hydroxychloroquine not only in COVID-19 patients but also as a prophylactic therapy.
Fauci was asked at the briefing to comment on Trump's remarks, but declined.
India bans hydroxychloroquine exports
On April 4, Trump said the U.S. had acquired 29 million doses of hydroxychloroquine but is seeking more supplies of the drug for COVID-19.
Trump said he called Indian Prime Minister Narendra Modi to ask him to lift his export restrictions imposed in March on the drug.
"And they are giving it serious consideration," Trump said.
But on the same day, Indian Director General of Foreign Trade Amit Yadav placed a full prohibition on exporting the drug "without any exception."
President Donald Trump with FDA Commissioner Stephen Hahn and Coronavirus Response Coordinator Deborah Birx
Federal stockpile redefined
Also last week, HHS changed the definition of the U.S. Strategic National Stockpile on the government's website a day after Jared Kushner, Trump's son-in-law and senior adviser, said the supplies were intended for the federal government and not states.
"The notion of the federal stockpile was it's supposed to be our stockpile. It's not supposed to be state stockpiles that they then use," Kushner told reporters April 2.
A number of reporters noted on Twitter HHS' website stated the stockpile was "for use in a public health emergency severe enough to cause local supplies to run out."
"When state, local, tribal and territorial responders request federal assistance to support their response efforts, the stockpile ensures that the right medicines and supplies get to those who need them most during an emergency," the website said.
But mid-morning on April 3, HHS replaced that language, stating instead the stockpile's "role is to supplement state and local supplies during public health emergencies" and to act as a "short-term stopgap buffer."
In a statement on Twitter, HHS said it first began working on updating the text "a week ago to more clearly explain the role of the Strategic National Stockpile" and noted it had used it in some recent statements.
On April 4, Trump said his administration could distribute the medical supplies to states but did not have to because "we need it for the federal government."