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WH Pushes Unproven Drug for Virus 04/07 06:03
President Donald Trump and his administration kept up their out-sized
promotion Monday of an anti-malaria drug not yet officially approved for
fighting the new coronavirus, even though scientists say more testing is needed
before it's proven safe and effective against COVID-19.
WASHINGTON (AP) -- President Donald Trump and his administration kept up
their out-sized promotion Monday of an anti-malaria drug not yet officially
approved for fighting the new coronavirus, even though scientists say more
testing is needed before it's proven safe and effective against COVID-19.
Trump trade adviser Peter Navarro championed hydroxychloroquine in
television interviews a day after the president publicly put his faith in the
medication to lessen the toll of the coronavirus pandemic.
"What do I know, I'm not a doctor," Trump said Sunday. "But I have common
sense." In promoting the drug's possibilities, the president has often stated,
"What have you got to lose?"
Trump held out promise for the drug as he grasps for ways to sound hopeful
in the face of a mounting death toll and with the worst weeks yet to come for
the U.S. The virus has killed more than 10,000 in the U.S., and measures meant
to contain its spread have taken a painful economic toll and all but frozen
life in large swaths of the country.
But medical officials warn that it's dangerous to be hawking unproven
remedies, and even Trump's own experts have cautioned against it.
The American Medical Association's president, Dr. Patrice Harris, said she
personally would not prescribe the drug for a coronavirus patient, saying the
risks of severe side effects were "great and too significant to downplay"
without large studies showing the drug is safe and effective for such use.
Harris pointed to the drug's high risk of causing heart rhythm problems.
"People have their health to lose," she said. "Your heart could stop."
In a heated Situation Room meeting of the White House's coronavirus task
force Saturday, Navarro challenged the top U.S. infectious disease expert, Dr.
Anthony Fauci, over his concerns about recommending the drug based only on
unscientific anecdotal evidence.
Navarro, who has no formal medical training, erupted at Fauci, raising his
voice and claiming the reports of studies he had collected were enough to
recommend the drug widely, according to a person familiar with the exchange who
spoke on the condition of anonymity to describe the blow-up.
Fauci has repeatedly said current studies provide only anecdotal findings
that the drug works. In response, Navarro told CNN on Monday, "I would have two
words for you: 'second opinion.'"
Hydroxychloroquine is officially approved for treating malaria, rheumatoid
arthritis and lupus, not COVID-19. Small, preliminary studies have suggested it
might help prevent the new coronavirus from entering cells and possibly help
patients clear the virus sooner. But those have shown mixed results.
Doctors are already prescribing the malaria drug to patients with COVID-19,
a practice known as off-label prescribing. Research studies are now beginning
to test if the drugs truly help COVID-19 patients, and the Food and Drug
Administration has allowed the medication into the national stockpile as an
option for doctors to consider for patients who cannot get into one of the
studies.
But the drug has major potential side effects, especially for the heart, and
Fauci has said more testing is needed before it's clear that the drug works
against the virus and is safe for such use.
Navarro told Fox News Channel's "Fox & Friends" that doctors in New York
hospitals are already distributing the drug to COVID-19 patients and that
health care workers are taking it in hopes of being protected from infection.
Asked about his credentials for pushing the drug, Navarro cited his
doctorate in social science and said that "in the fog of war, we might take
more risks than we otherwise would." He added, "I'd bet on President Trump's
intuition on this one."
Administration officials say Trump's embrace of the drug stems from his
desire to provide "hope" for the American people as the death toll mounts and
he looks to avoid political consequences from the outbreak.
Some limited studies have been conducted on the use of hydroxychloroquine
and antibiotic azithromycin in concert to treat COVID-19, but they have not
included critical control groups that scientists use to validate the
conclusions.
Researchers in China, for instance, reported that cough, pneumonia and fever
seemed to improve sooner among 31 patients given hydroxychloroquine compared
with 31 others who did not get the drug, but fewer people in the comparison
group had cough or fevers to start with.
Many questions have been raised about another study in France. Some of the
26 people given hydroxychloroquine in that test were not counted in the final
results, including three who worsened and were sent to intensive care, one who
died a day after later testing negative for the virus and one who stopped
treatment because of nausea.
The French study was published in an International Society of Antimicrobial
Chemotherapy journal. The society's president wrote on its website that the
report "does not meet the society's expected standard."
At least one other world leader has also promoted the drugs. Brazil's
President Jair Bolsonaro has touted the benefits of hydroxychloroquine and
azithromycin, saying he's heard reports of 100% effectiveness when administered
in the correct dosages.
Trump's interest in the drug was piqued in part by coverage on conservative
media.
On March 16, Fox News ran a segment on a small French study promoting the
effectiveness of hydroxychloroquine in treating the coronavirus. Hours later,
attorney Gregory Rigano appeared on a prime-time show and said evidence
suggested it could rid the body "completely" of the virus.
Almost instantly, just as the projections of the virus' impact on the nation
grew more dire, the drug's promise bounced around the echo chamber of the
conservative media. Just three days later, Trump himself made the first mention
of the drug.
Among the loudest voices in the president's ear has been Rudy Giuliani, the
president's personal attorney, who has spoken to Trump about the drug and
advocated it in interviews and his new podcast. He has had, as guests, several
experts touting the drug and made a few late-night phone calls to the White
House residence.
"I discussed it with the president after he talked about it," Giuliani said.
"I told him what I had on the drugs. Others around him believe it too."
The president's son, Donald Trump Jr., on Friday tweeted a link to an
article about the drugs' possible success and added: "Waiting for others to
write this up. The Democrats and the media must be really upset because they
tried to destroy @realdonaldtrump for being hopeful that this would be the
case."
Across Europe, there has also been a recent spike in demand for the drugs
even as regulators caution against their unlicensed use.
Last week, the European Medicines Agency warned doctors that since there is
no proof yet of the drugs' effectiveness, they should be used only in clinical
trials or under emergency use provisions.
The jump in demand for the drugs has meant in some instances that patients
who rely on hydroxychloroquine for lupus or other conditions are seeing their
supplies diverted for COVID-19.
If hydroxychloroquine is proven to work well against COVID-19, its sales
would jump, but pharmaceutical analysts say they don't know of any company or
individual that stands to make a windfall. That's because there's so much
competition and the vast majority of prescriptions filled are for generics.
For most people, the virus causes mild or moderate symptoms, such as fever
and cough that clear up in two to three weeks. For some, especially older
adults and people with existing health problems, it can cause more severe
illness, including pneumonia, and death.
(KR)
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