E-DRUG: BBC: Ivermectin: How false science created a Covid 'miracle' drug
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[The never stopping, rather increasing, problem of false claims for
medicines. It is so distressing. Copied from BBC World. On the website you
will find interesting graphics as well. KM]
https://www.bbc.com/news/health-58170809
By Rachel Schraer & Jack Goodman
BBC Reality Check
7 October 2021
Ivermectin has been called a Covid "miracle" drug, championed by vaccine
opponents, and recommended by health authorities in some countries. But the
BBC can reveal there are serious errors in a number of key studies that the
drug's promoters rely on.
For some years ivermectin has been a vital anti-parasitic medicine used to
treat humans and animals.
But during the pandemic there has been a clamour from some proponents for
using the drug for something else - to fight Covid and prevent deaths.
The health authorities in the US, UK, EU and Australia have found there is insufficient evidence for using the drug against Covid-19, but thousands of supporters, many of them anti-vaccine activists, have continued to vigorously campaign for its use.
Members of social media groups swap tips on getting hold of the drug, even
advocating the versions used for animals.
The hype around ivermectin - based on the strength of belief in the (phony) research
- has driven large numbers of people around the world to use it.
Campaigners for the drug point to a number of scientific studies and often
claim this evidence is being ignored or covered up. But a review by a group
of independent scientists has cast serious doubt on that body of research.
The BBC can reveal that more than a third of 26 major trials of the drug for
use on Covid have serious errors or signs of potential fraud. None of the
rest show convincing evidence of ivermectin's effectiveness.
Dr Kyle Sheldrick, one of the group investigating the studies, said they had
not found "a single clinical trial" claiming to show that ivermectin
prevented Covid deaths that did not contain "either obvious signs of
fabrication or errors so critical they invalidate the study".
Major problems included:
- The same patient data being used multiple times for supposedly different
people
- Evidence that selection of patients for test groups was not random
- Numbers unlikely to occur naturally
- Percentages calculated incorrectly
- Local health bodies unaware of the studies
The scientists in the group - Dr Gideon Meyerowitz-Katz, Dr James Heathers,
Dr Nick Brown and Dr Sheldrick - each have a track record of exposing dodgy
science. They've been working together remotely on an informal and voluntary
basis during the pandemic.
They formed a group looking deeper into ivermectin studies after biomedical
student Jack Lawrence spotted problems with an influential study from Egypt.
Among other issues, it contained patients who turned out to have died before
the trial started. It has now been retracted by the journal that published
it.
The group of independent scientists examined virtually every randomised
controlled trial (RCT) on ivermectin and Covid - in theory the highest
quality evidence - including all the key studies regularly cited by the
drug's promoters.
RCTs involve people being randomly chosen to receive either the drug which
is being tested or a placebo - a dummy drug with no active properties.
The team also looked at six particularly influential observational trials.
This type of trial looks at what happens to people who are taking the drug
anyway, so can be biased by the types of people who choose to take the
treatment.
Out of a total of 26 studies examined, there was evidence in five that the
data may have been faked - for example they contained virtually impossible
numbers or rows of identical patients copied and pasted.
In a further five there were major red flags - for example, numbers didn't
add up, percentages were calculated incorrectly or local health bodies
weren't aware they had taken place.
On top of these flawed trials, there were 14 authors of studies who failed
to send data back. The independent scientists have flagged this as a
possible indicator of fraud.
The sample of research papers examined by the independent group also
contains some high-quality studies from around the world. But the major
problems were all in the studies making big claims for ivermectin - in fact,
the bigger the claim in terms of lives saved or infections prevented, the
greater the concerns suggesting it might be faked or invalid, the
researchers discovered.
While it's extremely difficult to rule out human error in these trials, Dr
Sheldrick, a medical doctor and researcher at the University of New South
Wales in Sydney, believes it is highly likely at least some of them may have
been knowingly manipulated.
A recent study in Lebanon was found to have blocks of details of 11 patients
that had been copied and pasted repeatedly - suggesting many of the trial's
apparent patients didn't really exist.
The study's authors told the BBC that the "original set of data was rigged,
sabotaged or mistakenly entered in the final file" and that they have
submitted a retraction to the scientific journal which published it.
Another study from Iran seemed to show that ivermectin prevented people
dying from Covid.
But the scientists who investigated it found issues. The records of how much
iron was in patients' blood contained numbers in a sequence that was
unlikely to come up naturally.
And the patients given the placebo turned out to have had much lower levels
of oxygen in their blood before the trial started than those given
ivermectin. So they were already sicker and statistically more likely to
die.
But this pattern was repeated across a wide range of different measurements.
The people with "bad" measurements ended up in the placebo group, the ones
with "good" measurements in the ivermectin group.
The likelihood of this happening randomly across all these different
measurements was vanishingly small, Dr Sheldrick said.
Dr Morteza Niaee, who led the Iran study, defended the results and the
methodology and disagreed with problems pointed out to him, adding that it
was "very normal to see such randomisation" when lots of different factors
were considered and not all of them had any bearing on participants' Covid
risk.
But the Lebanon and Iran trials were excluded from a paper for Cochrane -
the international experts in reviewing scientific evidence - because they
were "such poorly reported studies". The review concluded there was no
evidence of benefit for ivermectin when it comes to Covid.
The largest and highest quality ivermectin study published so far is the
Together trial at the McMaster University in Canada. It found no benefit for
the drug when it comes to Covid.
Ivermectin is generally considered a safe drug, though there have been some
reports of side effects.
Calls over suspected ivermectin poisonings in the US have increased a lot
but from a very small base (435 to 1,143 this year) and most of these cases
were not serious. Patients have had vomiting, diarrhoea, hallucinations,
confusion, drowsiness and tremors.
But indirect harm can come from giving people a false sense of security,
especially if they choose ivermectin instead of seeking hospital treatment
for Covid, or getting vaccinated in the first place.
Dr Patricia Garcia, a public health expert in Peru, said at one stage she
estimated that 14 out of every 15 patients she saw in hospital had been
taking ivermectin and by the time they came in they were "really, really
sick".
Large pro-ivermectin Facebook groups have turned into forums for people to
find advice on where to buy it, including preparations meant for animals.
Some groups regularly contain posts about conspiracy theories of ivermectin
cover-ups, as well as pushing anti-vaccine sentiment or encouraging patients
to leave hospital if they aren't getting the drug.
The groups often provide a gateway to more fringe communities on the
encrypted app Telegram.
These channels have co-ordinated harassment of doctors who fail to prescribe
ivermectin and abuse has been aimed at scientists. Prof Andrew Hill, from
the University of Liverpool, wrote an influential positive review of
ivermectin, originally saying the world should "get prepared, get supplies,
get ready to approve [the drug]".
Now he says the studies don't stand up to scrutiny - but after he changed
his view, based on new evidence emerging, he received vicious abuse.
A small number of qualified doctors have had an exaggerated influence on the
ivermectin debate. Noted proponent Dr Pierre Kory's views have not changed
despite the major questions over the trials. He criticised "superficial
interpretations of emerging trials data".
Dr Tess Lawrie - a medical doctor who specialises in pregnancy and
childbirth - founded the British Ivermectin Recommendation Development
(Bird) Group.
She has called for a pause to the Covid-19 vaccination programme and has
made unsubstantiated claims implying the Covid vaccine had led to a large
number of deaths based on a common misreading of safety data.
When asked during an online panel what evidence might persuade her
ivermectin didn't work she replied: "Ivermectin works. There's nothing that
will persuade me." She told the BBC: "The only issues with the evidence base
are the relentless efforts to undermine it."
Around the world it was originally not opposition to vaccines but a lack of
them that led people to ivermectin.
The drug has at various points been approved, recommended or prescribed for
Covid in India, South Africa, Peru and much of the rest of Latin America, as
well as in Slovakia.
Health authorities in Peru and India have stopped recommending ivermectin in
treatment guidelines.
In February, Merck - one of the companies that makes the drug - said there
was "no scientific basis for a potential therapeutic effect against
Covid-19".
In South Africa, the drug has become a battleground - doctors point out the
lack of evidence but many patients desperately want access as the vaccine
rollout has been patchy and problematic. One GP in the country described a
relative, a registered nurse, who didn't book a coronavirus vaccine she was
eligible for and then caught the virus.
"When she started getting worse, instead of getting proper assessment and
treatment, she treated herself with ivermectin," she said.
"Instead of consulting a doctor, she continued with the ivermectin and got
home oxygen. By the time I heard how low her oxygen saturation levels were
(66%), I begged her daughter to take her to casualty.
"At first they were reluctant, but I convinced them to go. She passed away a
few hours later."
Additional reporting by Shruti Menon
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Kirsten Myhr, MScPharm, MPH
Norway
myhr[at]online.no