The first research scandal of the coronavirus pandemic has created
unnecessary distraction around the politically divisive drug
hydroxychloroquine, scientists say, as questions swirl around the tiny
health care company at the center of the affair.
On Thursday, most of the authors of major studies that appeared in The Lancet and the New England Journal of Medicine (NEJM)
retracted their work and issued apologies, saying they could no longer
vouch for their data after the firm that supplied it—Chicago-based
Surgisphere—refused to be audited.
At any other time the matter might have led to hang-wringing within
academia, but it has taken on a new dimension as the world grapples with
a virus that has claimed some 400,000 lives.
Of particular interest was the paper in The Lancet that claimed to
have analyzed the records of 96,032 patients admitted to 671 hospitals
across six continents, finding that hydroxychloroquine showed no benefit
and even increased the risk of death.
Its withdrawal is seen as a boost to backers of the decades-old
anti-malarial drug, who include US President Donald Trump and his
Brazilian counterpart Jair Bolsonaro.
“It’s very politicized—there is a group, probably not particularly
small, who have learned to mistrust science and scientists, and this
just feeds into that narrative,” Gabe Kelen, a professor of emergency
medicine at Johns Hopkins University, told AFP.
This is despite the fact that even without The Lancet paper, evidence
has been building against hydroxychloroquine’s use against COVID-19.
On Friday, results from a fourth randomized controlled
trial—carefully designed human experiments considered the most robust
form of clinical investigation—showed it had no impact against the
virus.
Mystery company
The Lancet, which first published in 1823, is one of the world’s most trusted medical journals.
As a result, the hydroxychloroquine paper had an outsized impact: the
World Health Organization, Britain and France all suspended ongoing
clinical trials.
But things soon began unravelling after researchers noticed numerous
red flags, from the huge number of patients involved to the unusual
level of detail about the doses they had received.
Both The Lancet and the equally prestigious NEJM, which
had published a paper on whether blood thinners elevated the risk of
COVID-19 that relied on the same company, issued expressions of
concern—before the authors themselves pulled both papers.
Surgisphere, founded in 2007 by vascular surgeon Sapan Desai, had
refused to share data with third-party reviewers, saying it would
violate privacy agreements with hospitals.
However, when science news site The Scientist began reaching out to
hospitals throughout the US to ask whether they had participated, it
found none.
Surgisphere’s internet profile has also raised numerous questions.
Only a handful of employees could be found on LinkedIn, and most have
now deactivated their accounts.
According to the Guardian newspaper, its employees included an adult
model and until last week the contact page on its website redirected to a
WordPress template for a cryptocurrency website, leaving it unclear how
hospitals could have reached out to them.
Meanwhile Desai, who according to court records has three outstanding
medical malpractice suits against him, has written extensively in the
past on research misconduct.
“The most serious cause of fraud in medical publishing is
manufactured data that authors use to support high impact conclusions,”
he said in a 2013 paper.
Systemic issues
For Ivan Oransky, who founded Retraction Watch in 2010, the affair is
far from surprising, serving instead to highlight systemic issues in
science publishing and the way science is reported to the public.
“No one took a hard look at the data,” said Oransky. “But we’ve known about these issues for literally decades.”
Policymakers should get away from the idea of using the results of a
single study to inform their decisions, he added, as was the case for
the WHO—and the media has a responsibility to place papers in context
instead of hyping them up.
The problem also stems from the fact that even leading journals rely
too heavily on an honor system, but “you never know when a catastrophe
is going to happen, if you’re not willing to put into place some
reasonable safeguards,” added Oransky.
As to the future, the current episode is unlikely to serve as a
wake-up call, he said. If one journal increases its diligence, more
blockbuster papers will start appearing in its competitors.
https://medicalxpress.com/news/2020-06-covid-scandal-unwanted-diversion-pandemic.html
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