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Ivermectin: Further claims of ‘serious errors or potential fraud’ in studies

An investigation claims further serious errors in various key studies on which the promoters of Ivermectin for COVID-19 rely. Citing a group of five scientists, BBC News reports that “more than a third of 26 major trials of the drug for use on COVID have serious errors or signs of potential fraud”.

For some years Ivermectin has been a vital anti-parasitic medicine used to treat humans and animals. But there has been a clamour from many to use the drug to fight COVID-19, despite health authorities in the US, UK, EU, and other countries, including SA, finding insufficient evidence to support this.

Pro-campaigners point to scientific studies and 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 shows 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 Sheldrick, each has a track record of exposing dodgy science, writes the BBC. They’ve been working together remotely on an informal and voluntary basis during the pandemic, and looked 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 It has now been retracted by the journal that published it.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 key studies regularly cited by the drug’s promoters.

The team also looked at six particularly influential observational trials, looking at what happens to those who are taking the drug anyway, so can be biased by the types of people choosing to take the treatment.

Out of 26 studies examined, five showed evidence the data might 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: numbers didn't add up, percentages were calculated incorrectly or local health bodies weren’t aware they had taken place. Apart from the flawed studies were 14 authors of studies who failed to send back data. The 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, Sheldrick, who is a researcher at the University of New South Wales in Sydney, believes it is highly likely at least some of them might 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 from dying of 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, Sheldrick said.

Dr Morteza Niaee, who led the Iran study, defended the results and the methodology and disagreed with problems pointed out to him, saying it was “very normal to see such randomisation” when many different factors were considered and not all 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 cases were not serious. Patients 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, 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 made unsubstantiated claims implying the 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 described a relative, a registered nurse, who didn’t book a coronavirus vaccine for which she was eligible 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 died a few hours later.

 

BBC article – Ivermectin: How false science created a Covid ‘miracle’ drug (Open access)

 

The Health Nerd Blog contains the analysis in five parts (Open access)

 

See more from MedicalBrief archives:

 

Ivermectin papers show limitations of ‘inherently unreliable’ summary data

 

COVID withdrawn over ethical concerns

 

Australian regulator bans off-label Ivermectin use as prescriptions climb

 

Ivermectin is not a ‘miracle drug’ against COVID. Vaccines are

 

UKZN professor challenges Ivermectin expose

 

Ivermectin fails as COVID-19 treatment in limited Colombian trial

 

 

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