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| Oracle Providing White House With Software to Study Unproven Coronavirus Drugs | Oracle Providing White House With Software to Study Unproven Coronavirus Drugs |
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| WASHINGTON — 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. | WASHINGTON — 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| The Oracle project has been heavily influenced by Dr. David B. Agus, a professor of medicine and engineering at the University of Southern California, who is working with the White House and Oracle, according to senior officials. Oracle’s co-founder, Lawrence J. Ellison, is a backer of Mr. Trump. | The Oracle project has been heavily influenced by Dr. David B. Agus, a professor of medicine and engineering at the University of Southern California, who is working with the White House and Oracle, according to senior officials. Oracle’s co-founder, Lawrence J. Ellison, is a backer of Mr. Trump. |
| Dr. Agus, a CBS News medical correspondent, has campaigned for the drugs over the past week, saying on television that “the earlier you use them, the better.” | Dr. Agus, a CBS News medical correspondent, has campaigned for the drugs over the past week, saying on television that “the earlier you use them, the better.” |
| Dr. Agus has boasted to senior administration officials that he has talked about the benefits of the drugs with Mr. Trump, who has publicly counseled that medical efforts not be wedded to traditional drug trials. That has alarmed senior health officials, who see the Oracle project as a way around the rigor and consensus of the government’s drug safety oversight. | Dr. Agus has boasted to senior administration officials that he has talked about the benefits of the drugs with Mr. Trump, who has publicly counseled that medical efforts not be wedded to traditional drug trials. That has alarmed senior health officials, who see the Oracle project as a way around the rigor and consensus of the government’s drug safety oversight. |
| On Tuesday afternoon, Dr. Fauci met with Drs. Deborah L. Birx, the White House’s coronavirus coordinator, Robert R. Redfield, director of the Centers for Disease Control and Prevention, and Stephen M. Hahn, the F.D.A. commissioner, to go over their concerns with the Oracle project and review new Chinese data that indicated the drugs have no meaningful effect. | On Tuesday afternoon, Dr. Fauci met with Drs. Deborah L. Birx, the White House’s coronavirus coordinator, Robert R. Redfield, director of the Centers for Disease Control and Prevention, and Stephen M. Hahn, the F.D.A. commissioner, to go over their concerns with the Oracle project and review new Chinese data that indicated the drugs have no meaningful effect. |
| One person familiar with the Oracle discussions said the project would be driven by science and data, not political calculations. Another person familiar with the conversations said there had been other talks between the Trump administration and television medical experts, such as Dr. Mehmet Oz, a widely watched and often criticized television personality who joined a Fox News-hosted virtual town hall with the president and Vice President Mike Pence on Tuesday to ask a question about hydroxychloroquine. | One person familiar with the Oracle discussions said the project would be driven by science and data, not political calculations. Another person familiar with the conversations said there had been other talks between the Trump administration and television medical experts, such as Dr. Mehmet Oz, a widely watched and often criticized television personality who joined a Fox News-hosted virtual town hall with the president and Vice President Mike Pence on Tuesday to ask a question about hydroxychloroquine. |
| In response to the question, Mr. Pence said that patients should defer to their doctors on whether to take the drug. | In response to the question, Mr. Pence said that patients should defer to their doctors on whether to take the drug. |
| On some of the president’s favorite Fox News programs in recent weeks, including Laura Ingraham’s, guests have pitched chloroquine as a coronavirus treatment. On March 14, Dr. Marc K. Siegel, a Fox News medical correspondent, said on “Justice with Judge Jeanine” that “no one is talking about" antiviral treatments, but that “we can try some of these treatments.” | On some of the president’s favorite Fox News programs in recent weeks, including Laura Ingraham’s, guests have pitched chloroquine as a coronavirus treatment. On March 14, Dr. Marc K. Siegel, a Fox News medical correspondent, said on “Justice with Judge Jeanine” that “no one is talking about" antiviral treatments, but that “we can try some of these treatments.” |
| Mr. Trump’s own chloroquine boosterism began as early as last Wednesday in a private Oval Office meeting, where he told a group of top officials, including Dr. Hahn, that promoting the drug would be a shot of inspiration for the public. The F.D.A., Mr. Trump said in the meeting, should promote chloroquine treatment, two senior administration officials said. | Mr. Trump’s own chloroquine boosterism began as early as last Wednesday in a private Oval Office meeting, where he told a group of top officials, including Dr. Hahn, that promoting the drug would be a shot of inspiration for the public. The F.D.A., Mr. Trump said in the meeting, should promote chloroquine treatment, two senior administration officials said. |
| Early that morning, and to the surprise of top officials at the F.D.A., Mr. Trump wrote on Twitter that he would be holding a news conference “to discuss very important news from the F.D.A. concerning the Chinese Virus!” Pleading with the White House, officials at the F.D.A. were able to hold it off, according to a senior administration official, forcing Mr. Trump to take his message to the next day’s coronavirus task force news briefing, where he told reporters that chloroquine would be distributed to “large groups of people” even before the government had concluded studying its safety and effectiveness. | Early that morning, and to the surprise of top officials at the F.D.A., Mr. Trump wrote on Twitter that he would be holding a news conference “to discuss very important news from the F.D.A. concerning the Chinese Virus!” Pleading with the White House, officials at the F.D.A. were able to hold it off, according to a senior administration official, forcing Mr. Trump to take his message to the next day’s coronavirus task force news briefing, where he told reporters that chloroquine would be distributed to “large groups of people” even before the government had concluded studying its safety and effectiveness. |
| “We’re going to be able to make that drug available almost immediately,” the president said. | “We’re going to be able to make that drug available almost immediately,” the president said. |
| At the same Thursday news conference, Dr. Hahn appeared to walk back the promise, saying it was the responsibility of the F.D.A. to make sure products are “safe and effective,” and that “what’s also important is not to provide false hope, but to provide hope.” | At the same Thursday news conference, Dr. Hahn appeared to walk back the promise, saying it was the responsibility of the F.D.A. to make sure products are “safe and effective,” and that “what’s also important is not to provide false hope, but to provide hope.” |
| A spokesman for the F.D.A. said that the agency has been working on therapeutics “from the beginning of this pandemic,” and has been keeping the White House and Mr. Trump apprised, including on hydroxychloroquine and chloroquine. | A spokesman for the F.D.A. said that the agency has been working on therapeutics “from the beginning of this pandemic,” and has been keeping the White House and Mr. Trump apprised, including on hydroxychloroquine and chloroquine. |
| Proponents of the drugs have cited Chinese and French reports that indicated they have been successful in treating coronavirus patients. But that research did not have control groups or other measures needed to determine whether a drug actually works. | Proponents of the drugs have cited Chinese and French reports that indicated they have been successful in treating coronavirus patients. But that research did not have control groups or other measures needed to determine whether a drug actually works. |
| Updated August 24, 2020 | |
| One article published in the International Journal of Antimicrobial Agents said that a combination of hydroxychloroquine and azithromycin, a common antibiotic, appeared to help patients. But that study involved giving hydroxychloroquine to just 26 people with confirmed coronavirus infections, including some with no symptoms. Only six of the patients were also given azithromycin. Some in the group did not even complete the study, including three who were sent to intensive care, one who died, and one who stopped treatment because of nausea. | One article published in the International Journal of Antimicrobial Agents said that a combination of hydroxychloroquine and azithromycin, a common antibiotic, appeared to help patients. But that study involved giving hydroxychloroquine to just 26 people with confirmed coronavirus infections, including some with no symptoms. Only six of the patients were also given azithromycin. Some in the group did not even complete the study, including three who were sent to intensive care, one who died, and one who stopped treatment because of nausea. |
| Dr. Joshua M. Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health and a former principal deputy commissioner at the F.D.A., said that the only way to know whether chloroquine works as a coronavirus treatment is through a high-quality clinical trial. | Dr. Joshua M. Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health and a former principal deputy commissioner at the F.D.A., said that the only way to know whether chloroquine works as a coronavirus treatment is through a high-quality clinical trial. |
| “I think there’s a major misconception in this country that getting good evidence means red tape,” he said. “Getting good evidence is knowing the difference between something that works and something that doesn’t.” | “I think there’s a major misconception in this country that getting good evidence means red tape,” he said. “Getting good evidence is knowing the difference between something that works and something that doesn’t.” |
| On Monday, an Arizona man died and his wife was hospitalized after they ingested chloroquine phosphate, a substance used frequently in aquariums to clean fish tanks, according to Banner Health, a hospital system based in Phoenix which treated the couple. The woman told NBC News that she took the substance, which she used on koi fish, after seeing Mr. Trump discuss it on television. | On Monday, an Arizona man died and his wife was hospitalized after they ingested chloroquine phosphate, a substance used frequently in aquariums to clean fish tanks, according to Banner Health, a hospital system based in Phoenix which treated the couple. The woman told NBC News that she took the substance, which she used on koi fish, after seeing Mr. Trump discuss it on television. |
| “Trump kept saying it was basically pretty much a cure,” the woman said. | “Trump kept saying it was basically pretty much a cure,” the woman said. |
| Dr. Daniel Brooks, a medical director with the Banner Poison and Drug Information Center, said on Monday, “It’s incredibly dangerous and foolish for people to be doing this.” | Dr. Daniel Brooks, a medical director with the Banner Poison and Drug Information Center, said on Monday, “It’s incredibly dangerous and foolish for people to be doing this.” |
| “This is not going to be a magic pill for us to get us through this,” he added. | “This is not going to be a magic pill for us to get us through this,” he added. |
| Some of the biggest pharmaceutical manufacturers, including Teva and Mylan, are ramping up production of hydroxychloroquine. Rising Pharmaceuticals, a manufacturer of chloroquine, has said it is also increasing production. And Bayer announced that it was donating millions of pills of chloroquine to the U.S. government. | Some of the biggest pharmaceutical manufacturers, including Teva and Mylan, are ramping up production of hydroxychloroquine. Rising Pharmaceuticals, a manufacturer of chloroquine, has said it is also increasing production. And Bayer announced that it was donating millions of pills of chloroquine to the U.S. government. |
| The demand for the drugs has caused a nationwide crisis for people with conditions reliant on hydroxychloroquine, like lupus and rheumatoid arthritis. Patients have described difficulty locating the drug at pharmacies, and hospitals have rushed to stash the treatments in an effort to treat severely ill patients. | The demand for the drugs has caused a nationwide crisis for people with conditions reliant on hydroxychloroquine, like lupus and rheumatoid arthritis. Patients have described difficulty locating the drug at pharmacies, and hospitals have rushed to stash the treatments in an effort to treat severely ill patients. |
| Doctors have begun hoarding it by writing prescriptions for themselves and family members, according to pharmacy boards in states across the country. | Doctors have begun hoarding it by writing prescriptions for themselves and family members, according to pharmacy boards in states across the country. |
| “The last thing I want to happen now is that, especially since President Trump and others have been mentioning this by name, is that people will go out and ask their doctors to write prescriptions, just in case,” said Onisis Stefas, the chief pharmacy officer for New York-based Northwell Health’s 23 hospitals. | “The last thing I want to happen now is that, especially since President Trump and others have been mentioning this by name, is that people will go out and ask their doctors to write prescriptions, just in case,” said Onisis Stefas, the chief pharmacy officer for New York-based Northwell Health’s 23 hospitals. |
| The stockpiling has become so worrisome in Idaho, Kentucky, Ohio, Nevada, Oklahoma, North Carolina, and Texas that the boards in those states have issued emergency restrictions or guidelines on how the drugs can be dispensed at pharmacies. | The stockpiling has become so worrisome in Idaho, Kentucky, Ohio, Nevada, Oklahoma, North Carolina, and Texas that the boards in those states have issued emergency restrictions or guidelines on how the drugs can be dispensed at pharmacies. |
| David McCabe contributed reporting from Washington, and Katie Thomas from Chicago. | David McCabe contributed reporting from Washington, and Katie Thomas from Chicago. |