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SUNDAY SCIENCE: INFAMOUS PAPER THAT POPULARIZED UNPROVEN COVID-19
TREATMENT FINALLY RETRACTED  
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Cathleen O’Grady
December 17, 2024
Science
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_ Study on hydroxychloroquine by Didier Raoult and colleagues gets
pulled on ethical and scientific grounds _

Scientists have been raising the alarm about research by
microbiologist Didier Raoult and his colleagues since early 2020.,
CHRISTOPHE SIMON/AFP via Getty Images

 

Related article:

‘Failure at every level’: How science sleuths exposed massive
ethics violations at a famed French institute
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By Cathleen O’Grady
7 Mar 2024

A 2020 paper that sparked widespread enthusiasm for hydroxychloroquine
as a COVID-19 treatment was retracted today
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following years of campaigning by scientists who alleged the research
contained major scientific flaws
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may have breached ethics regulations. The paper was pulled because of
ethical concerns and methodological problems, according to a
retraction notice.

The paper in the International Journal of Antimicrobial
Agents (IJAA), led by Philippe Gautret of the Hospital Institute of
Marseille Mediterranean Infection (IHU), claimed that treatment with
hydroxychloroquine, an antimalarial drug, reduced virus levels in
samples from COVID-19 patients, and that the drug was even more
effective if used alongside the antibiotic azithromycin. Then–IHU
Director Didier Raoult, the paper’s senior author, enthused about
the promise of the drug on social media and TV, leading to a wave of
hype, including from then–U.S. President Donald Trump.

But scientists immediately raised concerns about the paper, noting the
sample size of only 36 patients and the unusually short peer-review
time: The paper was submitted on 16 March 2020 and published 4 days
later. On 24 March, scientific integrity consultant Elisabeth
Bik noted on her blog
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six patients who were treated with hydroxychloroquine had been dropped
from the study—one of whom had died, and three of whom had
transferred to intensive care—which potentially skewed the results
in the drug’s favor. Larger, more rigorous trials carried out later
in 2020 showed hydroxychloroquine did not benefit COVID-19 patients
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Critics of Raoult’s paper have pointed out more damning problems
since. In an August 2023 letter
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in Therapies, Bik and colleagues noted the cutoff for classifying a
polymerase chain reaction test as positive was different in the
treatment and control groups. The letter also raised questions about
whether the study had received proper ethical approval, and noted an
editorial conflict of interest: IJAA’s editor-in-chief at the time,
Jean-Marc Rolain, was also one of the authors. (A statement saying he
had not been involved in peer review was later added to the paper.)
The letter called for the paper to be retracted.

The retraction notice states Elsevier and the International Society of
Antimicrobial Chemotherapy, which co-own the journal, decided to
retract the paper because of ethical issues, “as well as concerns
raised by three of the authors themselves regarding the article’s
methodology and conclusion.”

An investigation by Elsevier could not establish whether the
researchers had obtained ethical approval for the study before
recruiting patients, nor whether the patients had given informed
consent to be treated with the antibiotic azithromycin. This
medication would not have been part of standard care for these
patients in France at the time, the investigation concluded, so would
have been considered an experimental treatment that required consent.

According to the notice, the three authors who raised concerns about
the paper “no longer wish to see their names associated with the
article.” Gautret and several other authors told the investigators
they disagreed with the retraction, and the investigators did not
receive a response from Raoult, the corresponding author. To date, 32
papers published by IHU authors have been retracted
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28 of them co-authored by Raoult, and 243 have expressions of concern.

In a press release
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the French Society of Pharmacology and Therapeutics says the
now-retracted study was the “cornerstone” of a scandal that saw
millions of people take hydroxychloroquine unnecessarily, endangering
patients who experienced side effects including heart attacks. “This
series of events serves as a reminder of an essential point when it
comes to medicines: Even in times of health crisis, prescribing
medicines without solid proof of efficacy, outside the rigorous
framework of well-conducted clinical trials, remains unacceptable,”
the society says. “One of the fundamental principles of
medicine—_primum non nocere_ (‘first, do no harm’)—has been
sacrificed here, with dramatic consequences.”

doi: 10.1126/science.z8aky7n

CATHLEEN O’GRADY is a South African science journalist based in
Scotland. She has a Ph.D. in cognitive science from the University of
Edinburgh, where she studied evolutionary linguistics at the Centre
for Language Evolution. Her work has appeared in The
Atlantic, National Geographic, FiveThirtyEight, Hakai, and The
Guardian, among others. Cathleen covers behavioral and life sciences,
climate and environment, and science policy.

_The SCIENCE family of journals is published by the American
Association for the Advancement of Science (AAAS), the world’s
oldest and largest general science organization. The nonprofit AAAS
serves 10 million people through primary memberships and affiliations
with some 262 scientific societies and academies._

_A voice for science and scientists everywhere, AAAS fulfills its
mission to “advance science and serve society” by communicating
the value of science to the public, helping governments formulate
science policy, promoting advancements in science education and
diversity, and helping scientists develop their careers._

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