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 Hydroxychloroquine - which has anti-inflammatory and antiviral
properties - inhibited the coronavirus in laboratory experiments but
has not been proven effective in humans, particularly in
placebo-controlled, randomized clinical trials considered the gold
standard for data.
The debate has become highly politicized, and many scientists have
voiced concern.
Nearly 150 doctors signed an open letter to the Lancet last week
calling the article's conclusions into question and asking to make
public the peer review comments that preceded publication.
"This is not some sideshow or minor issue," said Dr. Walid Gellad, a
professor at University of Pittsburgh's medical school, who was not
a signatory of the letter but has been critical of the study.
"We're in an unprecedented pandemic. We've organized these enormous
clinical trials to figure out if something works. And this study
stopped or paused a couple of those trials, and changed the
narrative around a drug that no one knows if it works or not," he
said.
The observational study published in the Lancet on May 22 looked at
96,000 hospitalized COVID-19 patients, some treated with the
decades-old malaria drug that Trump said he took and has urged
others to use.
Several clinical trials were put on hold after the study was
published.
The study, using data provided by healthcare data analytics firm
Surgisphere, was not a traditional clinical trial that would have
compared hydroxychloroquine to a placebo or other medicine.
The Lancet's editors said in a note that serious scientific
questions about the study were brought to their attention and an
independent audit of the data has already been commissioned.
Surgisphere said in a statement that the audit "will bring further
transparency to our work (and) further highlight the quality of our
work."
Earlier on Tuesday, the New England Journal of Medicine (NEJM) said
it was concerned about the quality of the data behind a different
study it published in May that also used data from Surgisphere and
had the same lead author.
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Dr. Mandeep Mehra, the lead author and a professor of Medicine at Harvard
Medical School, defended the use of the Surgisphere dataset as an intermediary
step until clinical data is available.
"I eagerly await word from the independent audits, the results of which will
inform any further action," Mehra said in a statement after the Lancet note.
The World Health Organization (WHO) suspended hydroxychloroquine's use in a
large trial on COVID-19 patients after the Lancet study. Following the WHO trial
suspension, the governments of France, Italy and Belgium halted the use of
hydroxychloroquine for COVID-19 patients.
Among the critics of the study to sign the letter last week were several
academics from the University of Oxford and Mahidol Oxford Tropical Medicine
Research Unit (MORU) in Bangkok, which had been conducting the global "COPCOV"
trial of hydroxychloroquine as a treatment of COVID-19.
The trial was paused last week, after the Lancet article.
In March, Trump, with little scientific evidence, said hydroxychloroquine used
in combination with the antibiotic azithromycin had "a real chance to be one of
the biggest game changers in the history of medicine." He later said he took the
drugs preventively after two people who worked at the White House were diagnosed
with COVID-19.
Trump and Brazilian President Jair Bolsonaro discussed a joint research effort
on using hydroxychloroquine as both a prophylaxis and treatment for the
coronavirus, the White House said on Tuesday.
(Reporting by Michael Erman; additional reporting by Alistair Smout, Editing by
Bill Berkrot, Peter Henderson and Tom Brown)
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