MAVERICK CITIZEN
Little to lose: A doctor argues we must start using ivermectin now
There is so little downside to using this drug, and huge probable benefit. If it doesn’t work, we’ve lost little, other than hope. If it does, we’ve saved a life and, in some cases, a lifetime of disability.
The threat of death hangs in the very air we breathe. It has not felt so close or so frequent since my internship at the peak of the HIV pandemic. Similarities abound, as do differences – punishing hours, the exhaustion, the helplessness, the fear of infection.
In those days, to avoid infection from patients was simpler – double glove, avoid needlesticks. Now we wear masks, visors and gowns, like amulets warding off unseen demons.
My partner remarked: “It feels like internship without the rats and broken windows.”
The government didn’t care. President Thabo Mbeki withheld antiretrovirals, and nightly we wrapped his corpses. Now, Uncle Cyril’s caring presence is there to comfort. But the South African Health Products Regulatory Authority (SAHPRA) raids medical facilities and prosecutes doctors for prescribing ivermectin, a safe drug, though partly tested on Covid-19.
Again, the government appears to bungle access to the vaccine, and forcibly withholds a potential treatment while we watch our patients suffocate on their own body fluids.
A ‘wonder drug’, or false hope like hydroxychloroquine?
As scientists we want to look at the data. Does it work with Covid-19? As doctors we “first do no harm”.
The data are hopeful, and incomplete. There are no large-scale, randomised control trials proving its efficacy. The drug is off-patent and extremely cheap. No large pharmaceutical company has invested the considerable resources required for such a trial. There are many smaller, imperfect, randomised placebo-controlled trials showing significant effect. There are very few showing ivermectin doesn’t work, and they are generally underdosed.
The last trial published in The Lancet showed no significant difference in primary outcomes on a single dose, but we know we need at least two, if not five, doses to affect mortality. The research has been reviewed and analysed by prominent physicians and researchers, notably Andrew Hill (see his group’s research here or a video presentation of his work here), Paul Marik and Pierre Kory (see their research here), and Theresa Lawrie (see her meta-analysis of ivermectin here and her video to Boris Johnson here), all of whom show it works, with Lawrie saying the argument is “not whether it works, but how much it works”, as prophylaxis, preventing symptomatic disease and as treatment.
Public health policymakers such as the US National Institutes of Health (NIH) want large-scale trials, saying we’ve been fooled before. And they are correct, partly. Hill, a senior researcher at Liverpool University commissioned by the World Health Organisation to study ivermectin in Covid-19, reports that the chance of a so-called alpha error in his meta-analysis is one in 5,000. In other words, based on his data so far, the chance of his assertion that ivermectin appears to work when in fact it doesn’t is only one in 5,000.
How do you explain these complex statistics to a lay person?
A gentle grandfather of four was taking his family on a holiday. At airport security, he was found to have a bomb strapped to his chest. Incredulous, the security asked him what he was thinking. After all, he loved his family, who were travelling with him. “Exactly!” he said, with a twinkle in his eye. “What’s the chance of there being two bombs on the same plane?”
This grandfather was confusing the statistics of probability, which don’t apply when there is intentional action, but the joke makes a good point. Even though there are no large-scale trials, what is the chance of all the trials (of adequate dosing) all showing a benefit to using ivermectin – what is the chance of there being two bombs on the same plane?
At the risk of perseverating, Hill answers this inversely. The probability of the results of his meta-analysis of the data being by chance is one in 5,000. Said differently, according to his data so far, there is a one in 5,000 chance that he is wrong when he says ivermectin works. A one in 5,000 chance that it does not decrease the chance of people dying.
As my patients get sicker, I wonder about the downside of using it versus the 4,999 in 5,000 chance that it does benefit. What risk to my patients is there in using it, versus the chance that it may stop them dying or having permanent disability?
There is no free ride in medicine, but ivermectin has been shown to be safe in hundreds of millions of patients. Noted, it causes seizures, hepatitis, diarrhoea, skin rashes and other side effects, but the use of an SSRI (a selective serotonin reuptake inhibitor), a common antidepressant, carries a similar side effect profile and the same, if not greater, risk of seizure (one in 12,000).
Yet we use it freely and successfully.
We can treat seizures, we can’t treat death and permanent disability. There is so little downside, and huge probable benefit. If it doesn’t work, we’ve lost little, other than hope. If it does, we’ve saved a life and, in some cases, a lifetime of disability.
In concluding her analysis, Lawrie says the data are so strong as to render placebo-controlled trials unethical. This means that to give a placebo to a sick person is to withhold life-saving treatment that she can see works.
Other experts of deep ethical standing and compassion believe the data set is too small to draw any conclusions. The argument, crudely summarised, is: “What is the chance of there being two bombs on the same plane?” The experts are divided and for good reason.
But what do we have to lose? The chance of harm is low.
Of my many Covid-19 patients, one comes to mind. She is older than 60 and has other illnesses, increasing her risk of dying. She is struggling to breathe. Her oxygen saturation was holding up until last week, when it dropped precipitously. Her Interleukin 6, a predictor of respiratory failure (drowning in her own fluid), was doubling daily and not responding to steroids.
The family sourced ivermectin and asked my opinion. Should she take it?
I can only quote data, but cannot recommend it, for that would risk prosecution. Must I watch her die knowing there is so little downside of her taking a drug that may cure her? The law says so. The anxious family and patient must make a decision they’re ill-equipped to make and live with the consequences.
Some source the drug and, from what I’ve seen, do well. Others, for good reason, decide against it. Some do well, some don’t. I have no control group from which to draw definite conclusions.
SAHPRA invites clinical trials, which it will consider prior to approval. In normal times, this approach is correct and ethical, but explain to January’s mourners why it was approved in May.
There is another way.
Approve ivermectin for human use on parasites, where the efficacy and safety data are incontrovertible. This would allow doctors to legally and ethically use the medication off-label, as they do in most other countries, including the US and Australia. Given that the downside is so low, give us the opportunity to give it a shot without fear of prosecution. We don’t need a bureaucratic storm in a teacup. Not now. DM/MC
Paul Freinkel is a medical doctor in private practice in Johannesburg. He heads a family-based, multidisciplinary healthcare centre, and teaches on various Master’s and PhD programmes in South Africa and the UK.
"Information pertaining to Covid-19, vaccines, how to control the spread of the virus and potential treatments is ever-changing. Under the South African Disaster Management Act Regulation 11(5)(c) it is prohibited to publish information through any medium with the intention to deceive people on government measures to address COVID-19. We are therefore disabling the comment section on this article in order to protect both the commenting member and ourselves from potential liability. Should you have additional information that you think we should know, please email [email protected]"
Become an Insider
And some Aspirin to avoid thrombosis?
Paul, Obviously my next question is, so what was the outcome of the Lady that was dying, did she survive after the family, obviously agreed to give her ivermectin, What was the outcome. You supposed to tell the whole story, without fear or favor.❗️ Whats the problem now, tell us all. My story, it has just saved my sisters life, she had 3 days to live, Ivermectin brought her back, albeit, slowly, but she is back at 75 from death. Thats a true story. I have 3 family members it has saved, so i believe its worth the try. Better than no hope, as the vaccine, does not cure Covid. We need hope, living with the fear of death with no known drug cure, other than Ivermectin, which could work, is not an option.
Bruce, give it a break. Dr Freinkel’s career is at stake. He is committed to saving people’s lives. I had the same situation in a state hospital where professionals could not give me straight answers on an entirely different matter before this. Their dependents are at risk as well. We cannot selfishly consider only our own near and dear family members. The real problem is the money lever America’s Big Pharma has on all and sundry. Look at what happened when India made cheap HIV meds. Refer the uproar when Mbeki laid down the law on local pharmaceutical reception. We need to think much wider than just our own.
there is a less obvious risk to not formally allowing off-label use : incorrect use and using the wrong ivermectin. Social media is full of stories about how much of which animal treatment to use where on your body… Desperate people will get ivermectin as much as most smokers got tobacco during the ban. Now : people charge 500% more for blackmarket ivermectin of unknown quality…
Re the earlier article on Ivermectin and Covid you stated:
“The NIH in US approved Ivermectin for off-label use in last few weeks.”
For the record, you may refer to the following URL :
https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/ivermectin/
social media is also fired up that the reason ivermectin is blocked is because it is cheap. IT IS NOT CHEAP! A prophylactic treatment program for a 90kg person is 18mg now, another 18mg in 48 hours and then 18mg every two weeks. The generic 3mg ivermectin pill is therefore 6 pills per dose. The pills cost between $3 and $5 each (and a lot more but I am using cheap country prices like Canada). So call it $50 per month! The vaccines go for around $10 total, once.
It is cheap – number one because you can’t get the vaccine in South Africa right now, and if you have the virus, the vaccine won’t help you overcome the symptoms!
R750 and in most cases you are out of hospital in 48 hours, vs. languishing in hospital for 10-12 days. How much does that cost and how many resources does that tie up?
The vaccines have not yet been tested to be perfectly safe. So, maybe just a cheap death. A one in 5000 probability even of death on Ivermectin reduces to 0.02%. CoVid sites relate death rates of between about 1.7% to 2.74%. That means, on 1.7%/0.02%, you are 85 times more likely to die from CoViD. On 2.74% the likelihood goes up to 137 times. Attacking my figures is a waste of time as much as academic accuracy is in extraordinary times needing extraordinay measures. Besides red balloons burst. There are no guarantees in life. Especially not in this fake perfection medical silver bullets. My point. We need to get our heads straight and understand we have to face this and win it. As you say , there is a less obvious cost in waiting for and using the vaccine. Human life. It is common cause this government simply does not have the logistics in place to cover us all by vaccine. It is time for facing realities. People are dying while we argue about non-existing silver bullets.
Well said Dr Freinkel! “…explain to January’s mourners why it was approved in May”. There is already plenty of useful clinical trial data internationally and much more on the way by mid-Feb, so SAHPRA’s insistence on new trials is simply evil – no doubt caused by the SA government’s usual toxic cocktail of megalomania, incompetence and financial corruption. Except that this time the blood on their hands will be obvious.
Thanks Paul for a cogent and sober argument. I see SAHPRA has just approved controlled and supervised use of the meds. I lost dozens of people during the height of the HIV/AIDS crisis including some of the sharpest minds I knew at the time. As you may know there were a number of highly qualified and compassionate medical professionals, and experts, who were administering meds which were not legally available here. This was not black market stuff. This not irresponsible. It was desperate compassion. I am no medical expert but I did travel extensively at the time with access to such experts abroad. On a passport that was helpful. Thank you for speaking up. These are desperate times. From what I gather ivermectin is hardly dangerous. So extremely low risk it appears. Give it a chance. Whilst we wait again for a superbly ineffective government to figure out where the next tender should go.
Paul- you have not given any reason, biochemical or otherwise, why an antiparasitic drug would work against a virus, an entirely different infection. Parasites extracellular, viruses intracellular.
I hope I am proven wrong, but I think that encouraging people to take a veterinary medicine of no proven benefit to see if it helps is irresponsible and could even be dangerous.
Alan – Remember, Fleming discovered penicillin in 1928, it saved millions of lives during and after WWII and Dorothy Hodgkin figured out the structure of penicillin only years after the war, in 1949.
The actual biochemical mode of action (beta lactam disabling a bacterial enzyme essential for cell wall formation) was only finally figured out in 1981.
Ivermectin was discovered in 1975 and the biochemical mode of action on parasites was figured out only in 2011, decades after millions of people were saved from a fate of river blindness and other tropical diseases.
All this work eventually led to Omura, Campbell and Youyou jointly being awarded the Nobel Prize in 2015.
No doubt there’s a Nobel prize waiting (maybe 2035?) for whoever works out the biochemical mode of action of ivermectin on sars-cov2 in vivo.
But we don’t have to wait.. the numbers don’t lie, it’s effective, safe, we have a good idea of dosages, and the statistical significance of its effectiveness is so overwhelming some healthcare professionals say placebo controlled trials will be unethical.
Now if only we can get SAHPRA officials to actually read. Start with Kory et al. and then, if nothing else, approve Ivermectin for use against parasites, as another reader suggested.
Speaking of Nobel prizes.. I really hope someone nominates the frontline group represented by Dr Pierre Kory.
Thank you, well said! Approve ivermectin for parasites and the doctors can prescribe it. This will keep otherwise law abiding citizens from becoming criminals by sourcing the drug for themselves and their loved ones.
This is an excellent idea to get around the obstacles – but somebody has to urgently lodge the application with SAHPRA to have Ivermectin approved for parasites. The question then becomes, who can do so, and when, and what can we ordinary citizens do to assist?
With due respect to the very eminent author, arguments such as “there is little to lose” apply to just about any relatively harmless substance (eg garlic and onions) you care to put on the table.
The key indicator on whether or not a substance or drug is effective as a treatment against Covid is the scientific data. And here the sources the author has quoted do not inspire a great deal of confidence since they are at odds with key institutions such as the FDA in the United States and (as far as I can make out), the NIH (also in the US).
It would be interesting to know what the British regulatory authority’s reaction to Dr Hill’s 5000 in 1 chance of Invermectin NOT working is. I venture to suggest that if they accepted his findings, Astro-Zeneca would be out of business!
Can we agree that this debate should be about data? Reputable data. Cold hard numbers! And that findings of reputable authorities such as those I mention above should not be put in the balance against the various private clinical trials you mention above. Else we risk becoming a laughing stock (if we are not already so on account of weighty anti-vaxxer sentiment in political circles). That’s not something we can afford if we are serious about tackling this pandemic.