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Covid analysis 10pc results, 90pc methodology

By Dr Steve Humphries

Dr Steve HumphriesIn my last article I explained why our government doesn’t recommend ivermectin for treating Covid-19 – it’s because the studies supporting its use are of poor quality.

Scientific analysis is 10 percent looking at the results, and 90 percent looking at the methodology.

Speaking of methodology, one of the largest ivermectin studies, a 600-patient randomised control trial showing ivermectin could reduce Covid-19 mortality rate by an incredible 90 percent, has just been withdrawn. There were serious issues with the data and analysis. As one reviewer put it, the data appeared to be “just totally faked”. This is the second study to be withdrawn among allegations of fraud and fabrication.

I will reply to a letter to this paper arising from my last article as it raises some important issues.

The low number of reported Covid-19 deaths in Tanzania (21) is because the then president, John Magufuli, stopped the release of Covid-19 data at the beginning of the pandemic in April 2020, believing it might fuel public panic. Health professionals then felt unable to report Covid-19 for fear of government reprisal. The government was distrustful of vaccines and instead promoted local herbs and prayer. It didn’t go well.

Under a new president, Tanzania is now rolling out a mass Covid-19 vaccination programme.

People have argued that the low number of Tanzania’s reported Covid-19 deaths was because of the widespread use of ivermectin for treating parasitic worms. Not a convincing argument given the data being used.

The UK researchers who have concluded that the Covid-19 vaccines are “unsafe for humans” go against the results of all the clinical safety studies, and the Phase 4 worldwide pharmacovigilance programmes with more than four billion doses now administered. Their claim warrants scrutiny.

The UK researchers are a small private research and consultancy business, led by Dr Tess Lawrie. She says there are a “disturbing number of injuries and deaths as a result of the Covid jabs”. The evidence for her claim is the UK “Yellow Card” reporting scheme for vaccine side effects, with 1,037,376 adverse reactions to the Covid-19 vaccines ranging from mild to severe, and 1440 deaths, as of June 30, 2021.

But, as all reporting schemes warn, correlation is not causation: what we really want to know is not how many people died after the vaccination, but how many died because of the vaccination. This requires careful analysis that includes comparing the vaccinated deaths to what we would expect in a non-vaccinated matched population and looking at the timing and mechanism of individual deaths. Only then can it be determined how many deaths were caused by the vaccine.

But Dr Lawrie isn’t interested in this. She says the question is: “How many people have died within 28 days of vaccination?” That’s not the question at all. The question is: “How many people have died within 28 days because of vaccination?” For that she provides no data, though she could get that information from any number of pharmacovigilance databases.

So why does someone with a medical degree and a PhD provide information they must know is misleading? In denigrating Covid-19 vaccines, while promoting ivermectin as a cure for Covid, perhaps her ivermectin GoFundMe site provides the answer. Dr Lawrie’s claims about both Covid vaccines and ivermectin have been flagged on the internet as unsupported and misleading.

Beware of the mercenary contrarian. If science says masks help prevent Covid transmission, they say they don’t. If science says the PCR test is useful for tracking Covid infections, they say it’s ineffective. If science says we have good data for the safety of the Covid vaccine, they say the virus is killing people in droves. But, of course, they require donations for their cause, or a book to sell. Contrarian views are popular on social media, so it’s an attractive haunt for the mercenary contrarian – as their likes go up, so does revenue.

When large populations are vaccinated it’s not surprising there are many adverse events following immunisation (AEFIs). Some are simply coincidence; many are common mild vaccine responses such as headache or tiredness.

Rare serious adverse events are looked at carefully. If a safety concern arises, a vaccination programme may be halted pending additional analyses, possible further studies, and a risk-benefit analysis. After 1.8 million doses of the Pfizer vaccine administered in New Zealand, Medsafe reports no indications to suggest the vaccine has caused any deaths – as we would expect given the overseas analyses of AEFIs.

Another question raised is why do all the makers of Covid-19 vaccines seek government indemnities? No drug, or vaccine, is free of risk. Likely benefits are weighed against likely risks to determine if the risk is tolerable. Based on all the clinical trials, and the ongoing pharmacovigilance programmes, the Covid vaccines are assessed to have tolerable risk. But tolerable risk is not no risk, and in the large rollout of a pandemic (with billions of doses to be administered) adverse reactions to the vaccine will build up.

Who is to shoulder the burden of those adverse reactions? Vaccine companies argue society should not enjoy all the benefits of an acceptable risk vaccine made in good faith, while passing the burden back to them. If the vaccine companies were made liable, they would have to cover that cost, and vaccines would become more expensive. Claims would also have to be settled through the lengthy court process.

Our system works better. Based on independent assessment of the benefits and tolerable risk of a vaccine, our government takes on the liability. Covid vaccine injuries are then compensated through our ACC scheme. Vaccine companies don’t have full indemnity. They are still criminally liable for fraudulent misrepresentation of their vaccine’s safety or efficacy, or careless manufacture.

n Health scientist Dr Steve Humphries is a director at Hebe Botanicals in Ōtaki. He was previously a lecturer at Massey University and director of the Health Science Programme.

 
 
 

 

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