While the anti-malarial drugs are also being tested in clinical trials, the primary purpose of Oracle’s new website and mobile app is to help gather information on patients prescribed the medications outside of trials and more quickly assess whether the drugs — or any others that may emerge as possible treatments — are effective against covid-19, for which there is no proven treatment. The company plans to donate the site to the government.
Chloroquine and hydroxychloroquine are approved for malaria, so doctors can prescribe them for other illnesses. Some are trying them on patients with covid-19 based on anecdotal reports that they are sometimes helpful. The Oracle technology is meant to help the government collect data “in real time” and faster than in traditional Food and Drug Administration clinical trials, said one person familiar with the discussions, who spoke on the condition of anonymity because he was not authorized to speak publicly.
Oracle declined requests to comment for this story.
The administration is also exploring whether it will offer bonus payments to doctors who use the technology. This raises ethical concerns among some health officials, who fear that will further promote the use of unproven drugs, according to a person familiar with the plans, who also spoke on the condition of anonymity because he was not authorized to share the conversations. Some of the president’s top health officials have urged the government to proceed with randomized clinical trials to ensure they have definitive data about what does and does not work, several senior administration officials said.
The White House did not respond to multiple requests for comment.
Trump’s conversations with Ellison have played a significant role in the president’s recent statements during daily White House coronavirus briefings and on Twitter pushing the anti-malarials, according to four people familiar with the conversations, who spoke on the condition of anonymity because they were not authorized to share them.
The president’s recent statements underscore his desire for a quick fix to the rapidly escalating pandemic that has infected more than 53,000 Americans and killed upward of 600. They have also resulted in shortages of chloroquine and hydroxychloroquine for patients who need them for other uses. Even in private, the president has dismissed concerns from doctors that the drugs are not adequately tested, saying it is a dire situation and he wants people to have options, say senior officials.
Last week, shortly after Trump’s initial conversations with Ellison, he convened several top health officials and aides in an Oval Office meeting to discuss whether the government could expedite approval of chloroquine, hydroxychloroquine and remdesivir, an antiviral that has not been approved for any use but is currently being scrutinized in several late-stage trials.
The meeting included FDA Commissioner Stephen Hahn, Centers for Disease Control and Prevention Director Robert Redfield and Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, among others, according to people familiar with the gathering.
The officials pushed back on the idea, urging the president to wait for the results of randomized clinical trials that meet the FDA’s standards.
But Health and Human Services Secretary Alex Azar, who had been asked by Trump earlier that day to find legal authority to immediately approve the drugs, told the president he had conferred with his lawyers and had options for immediate approval if Trump wanted them, including emergency authorities granted to the health secretary.
A senior administration official said Azar was not advocating for immediate approval but presenting the president with options he had requested.
The other officials in the room were stunned at the suggestion and urged Trump to rely on the clinical trials.
Trump ultimately stood down, but still turned to Ellison and Oracle to build a website to collect data on the drugs’ efficacy outside of official clinical trials, and he has continued to push the drugs as possible treatments in daily briefings.
Ellison is heavily involved in health care, in addition to software. He launched a wellness company called Sensei and is a major shareholder in Quark Pharmaceuticals, which develops therapeutics based on gene discovery. He also funded a cancer institute at the University of Southern California led by Los Angeles doctor David Agus, who has been involved in discussions with the administration.
Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, said he had heard few details about the Oracle website but was unenthused based on what he knew.
“It sounds like a very poor substitute for a well-designed clinical trial,” said Sharfstein, who was FDA deputy commissioner during the Obama administration. He added that a trial could be conducted quickly without a large number of patients.
The fastest, best way to know whether something works is to randomly assign patients to treatments and then see what happens, he said. “Otherwise, it’s hard to know whether something works.”
Trump has repeatedly talked up the malaria drugs from the White House podium. He has cited a small study of 36 patients in France that administered chloroquine and an antibiotic called azithromycin. “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine,” Trump tweeted Saturday.
“I feel like I feel, as the expression goes, what do we have to lose? Because, you know, I feel very, I feel very good about it,” Trump said during a White House briefing Saturday.
Fauci interjected to say the president was right to have hope, but he urged caution in placing too much faith in the drugs without proper data.
“Many of the things that you hear out there are what I had called anecdotal reports. They may be true, but they’re anecdotal,” Fauci said. “So the only thing that I was saying is that if you really want definitively to know if something works, that you’ve got to do the kind of trial that you get, the good information. The president is talking about hope for people. And it’s not an unreasonable thing to hope for people.”
Medical and health experts have raised concerns that the president is pushing unproven treatments, leading people to try to obtain the drug. After hearing the president’s remarks, an Arizona man ingested chloroquine phosphate, a fish tank cleaner, in an effort to prevent covid-19, and died shortly after. His wife also ingested the substance and has been hospitalized.
“When the president comes in and says that he has a feeling that something is going to work very well, he makes it much harder to do that science,” said Ashish Jha, a professor at Harvard University and director of the Harvard Global Health Institute. “He makes it much harder for us to learn and figure out which treatments are going to work.”
On Tuesday, the state of New York was scheduled to begin testing chloroquine and hydroxychloroquine as treatments for covid-19.