The White House is preparing to use software provided by the technology giant Oracle to promote unproven coronavirus treatments, including a pair of malaria drugs publicized by President Trump, potentially before the government approves their use for the outbreak, according to five senior administration officials and others familiar with the plans.
An online platform designed by Oracle, in collaboration with the White House, is still taking shape, but it is likely to be used to collect information about off-label use of the drugs, chloroquine and hydroxychloroquine, which are not yet approved by the Food and Drug Administration to treat Covid-19, the disease caused by the coronavirus.
Mr. Trump has tried to reassure Americans that what he has called a “game changer” treatment is imminent, but his language has alarmed senior health officials and public health experts, who say that the Oracle program would amount to a sprawling, crowdsourced clinical trial without the usual controls of the F.D.A.
Chloroquine has been used to treat malaria for nearly a century; the bark of the quinine tree, where the drug comes from, has been used as medicine for hundreds of years. The president has been fixated on it for days. On Monday, at his orders, the federal government was helping obtain “large quantities” of it.
The president’s promotion has pitted him against some of his top health officials, including Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, who has warned that there is only anecdotal evidence so far that the drugs may be effective in treating the coronavirus. Amy P. Abernethy, the principal deputy commissioner of the F.D.A., said on Tuesday that a randomized controlled trial is the “most appropriate way” to decide whether the drugs are a suitable treatment.
Both drugs are still being studied by the F.D.A. for their effectiveness in treating the virus.
The president’s senior adviser and son-in-law, Jared Kushner, as well as agencies within the Department of Health and Human Services such as the Centers for Medicare and Medicaid Services and the F.D.A., are involved in the Oracle efforts, according to two senior administration officials.
Two senior administration officials familiar with the planning say it could gather data from physicians who prescribe the malaria drugs and track patient symptoms. The officials said planners had also discussed using the platform to mail the drugs to patients involved in the trial.
SOURCE: New York Times