05/16/20
For two months, President Trump repeatedly pitched hydroxychloroquine as a safe and effective treatment for coronavirus, asking would-be patients “What the hell do you have to lose?”
© Jabin Botsford/The Washington Post White House coronavirus response coordinator Dr. Deborah Birx, left, and Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony S. Fauci listen as President Trump participates in a vaccine development event in the Rose Garden on Friday
Growing evidence shows that, for many, the answer is their lives.
Clinical trials, academic research and scientific analysis indicate that the danger of the Trump-backed drug is a significantly increased risk of death for certain patients. Evidence showing the effectiveness of hydroxychloroquine in treating covid-19 has been scant. Those two developments pushed the Food and Drug Administration to warn against the use of hydroxychloroquine outside of a hospital setting last month, just weeks after it approved an emergency use authorization for the drug.
Alarmed by a growing cache of data linking the anti-malaria drug to serious cardiac problems, some drug safety experts are now calling for even more forceful action by the government to discourage its use. Several have called for the FDA to revoke its emergency use authorization, given hydroxychloroquine’s documented risks.
“They should say, ‘We know there are harms, and until we know the benefits, let’s hold off,’ ” said Joseph Ross, a professor of medicine and public health at Yale University, who added that the original authorization may have been warranted but new evidence has emerged about the drug’s risks.
“I’m surprised it hasn’t been revoked yet,” said Luciana Borio, who served as director for medical and biodefense preparedness of the National Security Council and was acting chief scientist at the FDA.
Testimony this week from a former top vaccine official removed from his post last month further highlighted allegations that Trump’s White House pressured government scientists to quickly sign off on the untested drug in March, at the same time the president was pitching it as a “game changer.”
Rick Bright, former director of the Biomedical Advanced Research and Development Authority, told Congress on Thursday that political pressure forced “dozens of federal scientists” to spend a harried 48-hour stretch rushing to put together a protocol for approving hydroxychloroquine for widespread use in covid-19 patients. Ultimately, that approach wasn’t taken. The FDA issued an emergency authorization for hospitalized covid-19 patients who cannot participate in a clinical trial.
In his whistleblower complaint, Bright said he was removed from his position in part because of his reluctance to promote the use of chloroquine and hydroxychloroquine, because they had not been tested and deemed safe for treating covid-19.
“It’s important to use available clinical data,” Bright told lawmakers. “And if we know there are potential risks, we need to make sure that we are cognizant of those risks and make sure those drugs are used in a very safe and controlled manner.”
The White House did not respond to requests for comment. Health and Human Services Secretary Alex Azar attacked Bright on Thursday, saying “his allegations do not hold water.”
In a recent interview, FDA Commissioner Stephen Hahn denied that he was pressured to authorize hydroxychloroquine: “I can assure you 100 percent that the president has never pressured me to make a decision regarding any regulatory aspect of the FDA’s work.”
The FDA said in a statement Friday that it is continuing to evaluate its emergency use authorization for chloroquine and hydroxychloroquine, as it does with all such authorizations for drugs to ensure their continued safety.
“In general, the FDA may revise or revoke an EUA under certain circumstances, including information related to linked or suspected adverse events, newly emerging data that may contribute to revision of the FDA’s initial conclusion that a product may be effective against the particular threat or a material change in the risk/benefit assessment based on evolving understanding of the disease or condition,” the statement said.
Trump has continued to promote hydroxychloroquine without reservation while attacking those who question its effectiveness. He has described Bright as a “disgruntled employee” who is resisting the proposed treatment without cause.
“So we have had some great response, in terms of doctors writing letters and people calling on the hydroxychloroquine,” Trump told reporters Thursday. “And this guy is fighting it. There’s no reason to fight it. There’s no reason. But more importantly than that, we’ve had tremendous response to the hydroxy.”
But doctors, health experts and officials from Trump’s own administration say the evidence does not back up the president’s positive assertions. Those assertions, which Trump has claimed are partly based on “a feeling,” could be costing lives, they said.
Yogen Kanthi, assistant professor in the division of cardiovascular medicine at the University of Michigan, said that it has been clear that the combination of hydroxychloroquine and azithromycin — used to treat bacterial infections — could lead to cardiac arrhythmias, which cause the heart to beat irregularly or too fast or slow. Many patients hospitalized for covid-19 had underlying cardiovascular disease that put them at higher risk for arrhythmias, “so it shouldn’t be surprising we saw an increase in death,” he said.
“The question has been answered that if you have the infection and it’s significant enough to be in the hospital, the drug doesn’t seem to do anything for you,” he said. “It may be the horse is out of the barn.”
Many hospitals have stopped using the drug outside of clinical trials.
“We no longer are keeping large quantities and have returned most of it,” said Nishaminy Kasbekar, director of pharmacy for the Penn Presbyterian Medical Center in Philadelphia. “I think they should revoke the EUA because clearly based on the data it is no longer considered a treatment for covid.”
Some doctors, including one in Texas who is also a Republican committeeman, have continued to give the drug to coronavirus patients — with mixed results.
A study of Veterans Affairs patients hospitalized with the coronavirus found no benefit and higher death rates among those taking hydroxychloroquine, researchers said last month.
More than 27 percent of patients treated with hydroxychloroquine died, and 22 percent of those treated with the combination therapy died, compared with an 11.4 percent death rate in those not treated with the drugs, the study said.
The National Institutes of Health announced Thursday that it had begun a clinical trial of 2,000 adults to determine if the combination of hydroxychloroquine and azithromycin — the cocktail touted by Trump — works as a therapeutic for those with coronavirus.
“Although there is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes,” Anthony S. Fauci, the nation’s top infectious disease expert, said in a statement.
While Fauci has cautioned against drawing broad conclusions from anecdotal evidence, Trump’s promotion of the drug has been almost exclusively based on personal stories he has heard — often on cable news. He has largely ignored scientific studies to pitch the drug without caveat.
In a tweet shared 102,800 times and liked 384,800 times on March 21 Trump claimed that “HYDROXYCHLOROQUINE AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine.”
He invited several recovered coronavirus patients to the White House last month, including some who said hydroxychloroquine saved their lives.
From mid-March through early April, Trump touted the drug as a potential panacea while downplaying any potential risks.
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