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 Bolsonaro - a vaccine skeptic and promoter of discredited treatments
such as hydroxychloroquine - said this new drug, Proxalutamide,
would "soon be available to all Brazil." He invited a little-known
Health Ministry official, Helio Angotti, to expand on its promise.
Angotti, an eye doctor with no epidemiological experience, cited a
domestic Proxalutamide study showing a 92% decrease in mortality
risk among hospitalized COVID-19 patients. It was a dramatic claim
amid a global struggle to find effective treatments. He said he
aimed to "get it to the Brazilian population as soon as possible."
But the study - co-authored by a consultant Angotti hired - hasn't
been peer-reviewed or published, beyond a cursory results
presentation the authors released in a March news conference. The
drug does not have regulatory approval and isn't available for sale.
Alexandre Cavalcanti, director of Sao Paulo's HCor Research
Institute, said the claimed effectiveness in the study Angotti cited
far exceeds any vetted COVID-19 treatment.
"I don't believe it," said Cavalcanti, who co-authored a major
study, published last year in the New England Journal of Medicine,
that found hydroxychloroquine essentially useless for COVID-19.
As a comparison, Cavalcanti cited the commonly used steroid,
Dexamethasone, has been shown to reduce deaths by up to one-third in
patients with severe COVID-19. The Chinese biotech firm that makes
Proxalutamide, Kintor Pharmaceutical Limited [9939.HK], has seen its
stock soar as it touted the Brazilian study and reported other
progress, Reuters reported in a related story https://reut.rs/3uPlT8p
today.
The appearance with Bolsonaro was the latest sign of Angotti's
rising influence amid a pandemic that has killed about 430,000
Brazilians. Current and former Health Ministry employees say the
mid-level official has quietly amassed power by elevating what they
say is questionable science to support Bolsonaro's convictions: that
masks are useless, lockdowns are dangerous, vaccines are no silver
bullet, and other miracle cures are available or soon will be.
Angotti declined to comment for this story. Bolsonaro's office and
the Health Ministry did not respond to requests for comment.
Carlos Wambier, one of the co-authors of the Brazilian Proxalutamide
study, acknowledged it lacked peer-review but said its findings were
"really very encouraging." He dismissed its critics as "more
concerned with politics than with scientific results."
"If the article is published, I believe any government in the world
will pay attention," said Wambier, a dermatology professor at Brown
University who specializes in cosmetic procedures such as Botox
injections and tattoo removal.
Reuters reviewed internal ministry documents and interviewed over
two dozen current and former officials, scientists and politicians
to chart Angotti's rise in Bolsonaro's administration. Angotti last
year became chief of the Health Ministry's Science, Technology,
Innovation and Strategic Inputs (SCTIE) department. Among other
duties, the SCTIE decides which drugs - not including vaccines -
Brazil's vast public health system purchases.
The sources said his department's focus on unproven coronavirus
remedies such as hydroxychloroquine, along with its opposition to
masks and lockdowns, contributed to the explosive spread of the
infectious P1 variant, which originated last year in Manaus, the
capital of Amazonas state, and made Brazil one of the world's worst
hotspots.
Federal prosecutors in Amazonas have accused Angotti of
administrative misconduct, in a civil proceeding that can result in
fines or job loss, for pushing health workers there to prescribe
hydroxychloroquine. Angotti declined to comment on that accusation.
Angotti is also under scrutiny in a high-profile congressional probe
into Bolsonaro's pandemic response. The Senate has been grilling
administration officials in public hearings for about two weeks, and
three senators have formally called for Angotti to testify before
the investigative committee, which has not yet considered their
requests. The committee will produce written findings but has no
power to punish administration officials.
Angotti's ascent reveals the central role that unproven treatments
continue to play in Brazil. It also exemplifies the unconventional
makeup of Bolsonaro's government, a coalition of soldiers, free
marketeers and social conservatives.
"Helio is the face of that anti-science group that seized control of
the ministry," said Adriano Massuda, who led the SCTIE department in
2015. "It's the ideological wing of the Bolsonaro government that
now gives orders at the Health Ministry."
Angotti's efforts to support Bolsonaro's pandemic strategy came as
the administration - now on its fourth health minister of the
pandemic - was widely criticized for Brazil's delayed vaccine
rollout. https://www.reuters.com/article/health-coronavirus-brazil-vaccines-idCNL1N2JW1R3
As other nations scrambled to cut deals with pharmaceutical firms,
Bolsonaro's administration was slow to secure vaccines for Brazil's
210 million people. About 15% of Brazilians have now received at
least one dose, compared with 36% in neighboring Uruguay, 46% in the
United States and between 20% and 35% in many European nations,
according to Our World in Data, a nonprofit public-service research
organization.
THREE CONSULTANTS AND A RESEARCH MEMO
Angotti taught at a university in southeastern Brazil before he
joined the Health Ministry in 2019, when Bolsonaro took office. He
served as a health education manager before being promoted last
June. Like Bolsonaro, Angotti is an avowed follower of the esoteric
Brazilian philosopher Olavo de Carvalho, who promotes false
conspiracy theories including a claim that Pepsi used the cells of
aborted fetuses as sweetener.
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Bolsonaro, who took hydroxychloroquine when he contracted the virus
last July, has questioned the safety and effectiveness of vaccines
and declined to take a shot himself. Angotti declined to comment to
Reuters on whether he considers vaccines effective.
By November of last year, Angotti had hired and assigned three
consultants to find evidence to support Bolsonaro's medical claims,
according to a Nov. 19 memo Angotti wrote. The memo, reviewed by
Reuters, hasn't been previously reported.
Among the consultants were Ricardo Zimerman, an infectologist with
some 60,000 followers on Instagram, where he regularly posts news
about experimental COVID-19 treatments and photos of himself pumping
iron. The two others were Bruno De Souza, a management professor at
the Federal University of Pernambuco who also has a doctorate in
psychology; and Rute Costa, a medical researcher.
The consultants did not respond to requests for comment.
Angotti's Nov. 19 memo instructed the consultants to "list and
criticize the protocols and articles related to the different
immunization proposals." The consultants were also to update the
ministry protocol for treating COVID-19 with a cocktail of anti-malarials,
such as hydroxychloroquine, along with other drugs. Angotti told
them to add "the newest proposed therapies," showing how they can
"save many lives."
The memo also directed the consultants to produce a "comprehensive
assessment" of lockdowns, focusing on the "social and economic
impacts of social isolation." In March, the consultants co-authored
a study that went beyond examining social-isolation impacts and
concluded that lockdowns were "associated" with the emergence of the
P1 variant in Manaus, asserting that the virus had mutated in
cooped-up households.
In early December, the consultants shocked some staffers on the
ministry's coronavirus operations desk with a presentation on why
masks don't work to control virus spread, according to two people
present. Others were less surprised: When Bolsonaro visited the desk
in October, officials were told not to wear masks, according to a
person in attendance.
HYDROXYCHLOROQUINE TO THE RESCUE
As Angotti's team chased evidence for unproven treatments, the P1
variant exploded in Manaus, accounting for three-quarters of the
city's cases by the end of January, according to a study by Fiocruz,
a federally funded biomedical institute. The city's hospitals
quickly ran out of oxygen; the variant soon spread across Brazil.
The Health Ministry sent at least 120,000 hydroxychloroquine pills
to Amazonas state and flew 12 medical professionals to the city of
Manaus to push healthcare workers to use anti-malarials. Zimerman,
De Souza and Costa were in the group, according to a Feb. 23
statement sent by one of Angotti's colleagues to federal prosecutors
in Amazonas, responding to their inquiries about the ministry's
handling of the Manaus crisis. Angotti's SCTIE financed their trips,
the statement says.
The ministry also deployed a short-lived phone app that purported to
help medical professionals diagnose COVID-19 with a symptoms
questionnaire - then instructed them to prescribe anti-malarials
like hydroxychloroquine. The app was based on a diagnostic tool that
Angotti's consultants helped to develop.
Less than two weeks after its January launch, Brazil's Federal
Council of Medicine (CFM), which licenses and regulates medical
professionals, asked the Health Ministry to deactivate the app
because it claimed "scientific validation for drugs without
international recognition." The council said the app had been
available to people who were not doctors and that it encouraged them
to self-medicate. The ministry shut the app down.
The focus on hydroxychloroquine in the Manaus crisis was emblematic
of the Bolsonaro administration's failed pandemic response, said
Felipe Naveca, one of the first scientists to study the P1 variant
and the deputy research director at the Fiocruz Amazônia biomedical
institute, the organization's outpost in Manaus.
"The scale of the problem was never taken seriously," he said. "So
they focused on a miraculous solution that doesn't exist."
Amid the chaos in Manaus, one of Angotti's consultants, Zimerman,
joined with other researchers to launch the study of Proxalutamide,
the drug Bolsonaro and Angotti would later tout on the social media
video. On March 10, just weeks after starting the study, the authors
called a news conference in Manaus to announce their results.
"As a researcher, I can confirm that I've never seen anything like
this - and I conduct a lot of trials," said Cadegiani, one of the
study's co-authors. "We're not kidding around."
Cadegiani declined to comment on the criticisms of the study.
Cavalcanti, the Sao Paulo scientist, said the presentation of
findings for the still-unpublished study didn't meet the standards
for such research.
"That study is amateur," he said. "The way it was announced, how the
data were presented, those guys are amateurs."
(Reporting by Gabriel Stargardter; editing by Brian Thevenot)
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