In an earlier post, I wrote about the FDA trying to stamp out the practice of some people using the livestock deworming drug ivermectin as a Covid-19 treatment. We have even reached a stage where people are going to court to force hospitals to provide it to patients.
When there is a matter of urgency like covid-19, a lot of exploratory research is done on treatments, using small samples or on animals or in petri dishes. In the age of the internet, the results of such studies can become widely known and people can seize on any positive information and think that the treatment should be freely used, even if there is the potential for danger. In the case of ivermectin, it has not yet been shown to be an effective treatment against the virus and can be dangerous in large doses. Preliminary results showed no appreciable efficacy.
Based on the current very low‐ to low‐certainty evidence, we are uncertain about the efficacy and safety of ivermectin used to treat people with COVID‐19 in the inpatient and outpatient settings and to prevent a SARS‐CoV‐2 infection in people after having high‐risk exposure. There is also no evidence available from the study pool as to which is the best dose and regimen of ivermectin. Overall, the reliable evidence available does not support the use of ivermectin for treatment or prevention of COVID‐19 outside of well‐designed randomized controlled trials (RCTs).
Clearly both prevention (using vaccines) and treatments should be explored. But prevention is to be preferred since it is always easier to do that with a simple injection than treating acute medical conditions. But we are long past the time for such subtleties. We are now in a situation where people seem to have chosen sides in the prevention and treatment debate and rather than seeing them as complementary paths that should be both pursued, now see them as enemies.
This trend had caught me unawares and I became curious as to how it originated and this article clued me in. It started with small studies during the early days of the pandemic, a time of desperation when people were exploring all manner of options, that suggested that this cheap and plentiful drug may have some benefits in treating covid-19. But when scientists started examining it more closely using standard protocols, they encountered a hostile reaction.
The University of Minnesota physician and infectious disease researcher [David Boulware] had seen a few small but encouraging studies on the drug, which was most often used by vets to treat parasites in horses and sheep (and sometimes lice and scabies in people). Boulware, who specializes in running clinical trials, set up the study early in 2021 with a methodology considered to be the gold standard: the randomized controlled trial, where one group of patients receives the drug, and the other gets a placebo.
In May, Boulware’s team put the word out about the study, aiming to recruit 1,100 volunteers. But then something strange happened: He began receiving hostile emails and messages on Twitter from people who fervently believed that ivermectin was a miracle cure for COVID-19 and that administering a placebo to some trial participants was therefore unethical. “Are you a reembodied NAZI Josef Mengele?” wrote one in an email. “WHAT ARE YOU THINKING? Eliminate your plan to abuse people as needless controls. You have a duty of care.”
Boulware was stunned. In decades of running similar trials for diseases including HIV/AIDS and tuberculosis, he had never received any feedback from strangers, let alone hate mail. But as all things COVID-19 seem to have become politicized, so too has clinical research. There is a growing divide between people who believe the key to ending the pandemic is in preventive measures—vaccines, masks, and distancing—and those who favor treatments. Clearly, these two public health approaches should not be mutually exclusive, but somehow in the current climate, they are. Angela Reiersen, a clinical researcher who is studying potential COVID treatments at Washington University in St. Louis, has seen this pattern play out on her own Twitter feed. “If I post something about vaccines as positive, then I will have a lot of people jumping on that and attacking me, and it’s these people who are all pro early treatment,” she told me. When she tweets good news about potential treatments, on the other hand, she has noticed that she provokes the ire of vaccine advocates. “They kind of seem to suppress any information about early treatment,” she said, “maybe because they feel like it’s going to make people think they don’t need to be vaccinated.”
Often, but not always, the divide is partisan, with the left on Team Prevention and the right on Team Treatment. President Trump sowed the seeds for this dynamic with his full-throated endorsement of the malaria drug hydroxychloroquine. Even after it turned out to be a dud, Trump, Fox News, some right-wing physicians, and other right-wing media outlets continued to tout its supposed benefits. As it happened, a raft of studies, including preliminary results from the first large trial, ultimately found that ivermectin was not terribly effective at treating COVID-19. Accordingly, Boulware has since moved on to studying other drugs (including a promising antidepressant called fluvoxamine, which I’ll come back to later). Yet despite the evidence against ivermectin, the same conservative pundits who promoted hydroxychloroquine have now taken up the ivermectin cause, and, with scant scientific evidence, tout both ivermectin and hydroxychloroquine as highly effective treatments.
Physicians prescribing “off-label” uses of drugs to treat patients for whom the standard treatments are not appropriate, and rigorous double-blind studies to see if that treatment is generally effective, are not mutually exclusive practices.
[T]here is one key piece of nuance that has been lost in outlets’ breathless reporting about treatments that don’t seem to work. In some cases, it may be appropriate for a doctor to prescribe a COVID drug for which the evidence is mixed or not robust—say, if a patient is suffering from a condition that disqualifies them from receiving standard treatment. When prescribing drugs, physicians generally follow guidelines from the National Institutes of Health, which are based on an extensive body of studies and clinical trials. But these guidelines aren’t law. Also, because they look at overall evidence of benefit to a population rather than focusing on individual patients, there are legitimate reasons to deviate from them. If doctors think certain drugs might help a patient for specific reasons, they are allowed to—and regularly do—prescribe drugs “off-label,” or for a purpose that’s different from their approved use. Currently, the NIH recommends only a few COVID-19 drugs for outpatients at risk of severe complications—certain kinds of monoclonal antibodies, as well as some steroids.
Part of the problem is that running large-scale clinical trials to show that a drug that has shown some promise in lab tests or with animals or in small trials works on a large scale is expensive and usually, at least in the US, is at least partly funded by drug companies hoping to reap profits later. But if the drug is already available cheaply or in generic form, then getting funding for such studies is not easy unless governments are willing to do it.
All these are important questions that should be explored but doing so thoughtfully is hard because we seem to have reached a stage where pretty much every issue where there are multiple options quickly devolves into a partisan binary battle where people are expected to choose sides and the other is viewed as the enemy.
I was under the impression that if a patient is on the verge of death, then one can usually get approval for emergency use of an experimental treatment or for off-label use. It is not clear what the situation is concerning the patient for whom the judge ordered the ivermectin treatment.
Michael Kosta thinks there may be a way to reach the ivermectin enthusiasts.
Reginald Selkirk says
It seems clear enough to me. The patient is very sick with COVID-19 in a hospital. The patient’s wife found a doctor who is not affiliated with the hospital who is all-in for ivermectin. This quack doctor thinks the patient should receive ivermectin, but the hospital, which is staffed with competent people, says no. So the patient’s wife takes to the courts.
Scientists have done a well designed clinical trial. Ivermectin doesn’t work for Covid-19 virus.
This patient has been on a ventilator for a month. This article has his prognosis as 30%. In other words, low.
Ivermectin has a large number of side effects, depending on the dose and the patient’s condition. The danger here is not negligible. With a patient this sick, Ivermectin could well just push him over the edge, from living to…dead.
Matt G says
Is the bit about vaccine advocates getting down on treatment successes an attempt to create balance? The ultimate goal, I believe, is to save lives (except for those interested in “owning” their opponents). An ounce of prevention is worth a pound cure, and treatment for COVID is a huge drain on limited resources (human, medical, etc.). I’m having a hard time accepting that pro-science people aren’t happy about newer, better treatment options. What we are unhappy about is the shocking wastefulness of the treatment-only crowd.
There is no divide.
At least on the science and medicine side.
You need both prevention and treatment. Because neither works all the time on their own.
Right now, treatment for Covid-19 virus isn’t all that great. It’s mostly treating the symptoms, not the cause. The only direct antivirals are remsdesivir and a few monoclonals and they work best given early in the disease process and not all that well. The ventilators have their own set of problems. The best survival I’ve seen with ventilator patients is 75%. Sometimes it is 5%.
It also costs a lot. The average hospitalized patient runs up a bill of $50,000. A vaccine costs something like $10 to $35.
We need antiviral drugs like we have with HIV. 40 different drugs in 7 or 8 different classes. OTOH, those HIV drugs took several decades to develop. Drug development is much slower than vaccine development. People are working hard on anti-Covid-19 virus drugs, but it will be years before we see them.
Reginald Selkirk says
I agree with Matt G @4. There is no bias on “the left” (i.e. among sane and rational people) against treatments that work. The problem with ivermectin is that it does not work. I am all for treatments that do work, because of breakthrough infections, people who cannot legitimately be vaccinated, and the possibility of new variants that circumvent the vaccine.
It should also be clear that ignoring available prevention for petty political reasons is stupid. Because even if treatments that work do materialize, it costs more -- in both money and health -- to treat a sick person than to prevent illness in the first place. And perhaps a person might find themself in a position where treatment is not available readily.
Stop the “both-sides-ism”. It is not an accurate portrayal of reality.
consciousness razor says
What’s amazing is how quickly (and almost imperceptibly) the roles were reversed for many Ds and Rs after the election. When it was still thought of as Trump’s vaccine, many either believed immediately that it would do miracles or they claimed it would be dangerous and should not be taken. Sounds familiar, no? It’s just that a few months later, those positions were adopted by completely different people, because the political circumstances as they saw them had changed.
Don’t believe me or don’t remember? Here’s a fairly stomach-churning Twitter thread, among many others like it, which obviously came after both Biden and Harris had expressed their vague “concern” while on the campaign trail.
I admit that I was also somewhat skeptical that a vaccine could be properly tested in such a short time. I did nonetheless get it as soon as I could and have tried to convince others to do the same. And of course, we have learned more about how effective it really is as the months have gone by and many more people have taken it. Fortunately, it wasn’t a complete disaster …. only about half of a disaster I guess.
It’s also worth pointing out that other strategies to fight the pandemic that we’ve been entertaining have ebbed and flowed along with these tides of evidence-free opinion and fear-mongering propaganda. So, what we’ve gotten along those lines is a disorganized and inconsistent clusterfuck of inadequate policies, as well as even less trust in so-called experts and officials in the government.
I don’t think you can explain much about any of it, based on who the current vaccine-hesitant/anti-vaxxer crowd happens to be (i.e., they’re science-hating Republicans and so forth) Because if Trump had won and nothing else were different, many of these people would just be trading places, yet the stories we’re telling ourselves to try to make sense of it all would be totally different.
Reginald Selkirk says
Another treatment that has done well in a large clinical trial: Fluvoxamine
BTW, it is my understanding that remdesivir is not that great.
ZOMG, Horsey Vax was hilarious.
And as always, This Modern World was spot on.
“Treatment only” will rapidly over-run any medical system, but will keep undertakers in business.
Matt G says
raven@5- Speaking of HIV, I just read that a vaccine trial by J&J using the same adenovirus system as their SARS-CoV-2 vaccine didn’t go well: 25% efficacy.
Who Cares says
They didn’t really speed up the creation & development or testing. The main time saving was achieved speed running the bureaucracy. First they got out the emergency use playbook instead of full authorization, then they ran as much of the red tape as possible concurrently instead of consecutively and with priority instead of putting it at the bottom of the pile as would happen in normal times.
Reginald Selkirk says
@12 -- I would argue that the technology has sped up creation and development. Pfizer/BioTech and Moderna used mRNA technology, J&J used adenovirus. This means that the tedium of finding conditions to grow virus and to purify viral protein is replaced with a software problem -- which content to load.
Yes, the bureaucracy was also sped up.
@12 & 13,
The third piece of that puzzle is that mRNA vaccine delivery systems had been in development for almost 20 years, since the first SARS scare. So there was a long history of creation and development of the mRNA technology, with lots of testing and results. The work was even done using similar respiratory viruses, so it wasn’t like they were adapting a technology developed for a measles vaccine.
In short, we were incredibly lucky that researchers had been working on the mRNA technology and had it basically ready to go for this pandemic. If we had to rely on traditional vaccine development we would probably have a vaccine available (there would have been incredible political pressure to release something at the same time the Russians and Chinese did), but it would likely only be 40-60% effective.
Then these squash-heads decide that a substance which will stimulate their personal immune system to fight off the disease is more risky than livestock de-wormer. Mainly due to talking-heads JAQing off.
Who Cares says
Moderna might have been working on vaccines as well but BioNTech only signed a deal to develop a Flu vaccine in 2019. Further mRNA is not a guarantee that a vaccine is successful, CureVac is a good example of that when they withdrew their candidate for only getting 47%.
The range for Adeno viruses is 50%-90%, Oxford (AZ) 76%, J&J 74%. Technically speaking Sputnik could hit the 90%+ due to the use of two different vectors but we don’t know for sure due to the Russians refusing to hand over the data needed to make a correct assessment (and what is being shipped from different production plants being so different from what comes from the other plants that even friendly regimes won’t approve it), which also makes it likely that it didn’t hit the 90% but 50%-70%.
Traditional vaccine development was as speedy as the mRNA vaccines, AZ/Oxford was developed on the same timetable as the mRNA vaccines (even if you exclude the BoJo stunt of approving it). You haven’t heard of Merck and a host of other big name companies since their candidate(s) were found lacking at roughly the same time that AZ/Oxford and Moderna and Pfizer/BioNTech managed to complete their phase 3.
“In decades of running similar trials for diseases including HIV/AIDS ”
I was volunteering for AIDS Service Center, the only place on the west coast where you could get help (in NYC it was Gay Men’s Health Crisis). This divide in approach philosophy is as old as that if not older. (Read some accounts of plague in Europe and you tell me.) When I read that quoted bit, I wonder if that doctor is faking his resume.
The Centers for Disease Control AND PREVENTION got that extra phrase added to its name on-purpose because in the minds of quite a few people they are NOT the same. It is irrelevant how dumb that any all y’all think that they are. Those folks will remain both disease reservoirs and opposition to collective action as long as you continue to hide in your lexical ivory tower about how words are used.
Beating them over the head and/or ridiculing them will not get you their cooperation. You can pretend you don’t need it all you like. … … … yeah keep on doing that … sure.
Mr Singham and his band are acting more and more like dead-enders.
They are afflicted with the TDS (Trump Derangement Syndrome) virus and there is no vaccine against the TDS virus. So they go around searching for “studies” that feeds to their confirmation bias that all treatments involving Ivermectin or hydroxychloroquine MUST be BAD!!! Why? Because Orange-Man-Bad mentioned hydroxychloroquine.
Mr Singham’s credibility drops when he mis-characterizes a study he referenced. The study made no conclusions, just stated that the results were conflicting. Another study Mr Singham referenced was based on a dubious assumption that ivermectin interferes in viral reproduction. The physicians in the field used ivermectin for its anti-inflammatory properties, NOT for anti-viral properties. Different assumptions, different lines of treatment, different results. The targets of anti-inflammation drugs are not the viruses but specialized white blood cells which can cause cytokine storms.
Ivermectin has been gaining momentum. The chairman of the Tokyo Medical Association, Haruo Ozaki, held a press conference Feb. 9, 2021 announcing that the anti-parasite medicine Ivermectin seems to be effective at stopping COVID-19 and publicly recommending that all doctors in Japan immediately begin using Ivermectin to treat COVID.
A prominent Japanese physician, Dr. Kazuhiro Nagao, appeared on Japanese television proposing that COVID-19 should be treated as a Class 5 illness as opposed to its current classification as a Class 2. In Japan, illnesses are categorized by a classification system; approaching COVID as a Class 5 illness would mean that it could be treated like a seasonal flu.
Dr. Nagao said he has used Ivermectin as an early treatment for over 500 COVID patients with practically a 100% success rate, and that it should be used nationwide.
Meanwhile…….Israel recorded 1,892 cases per million people on Wednesday (Sept 1) — nearly 0.2% of entire population in single day.That was significantly higher than second worst-hit Mongolia, where the rate was 1,119 per million, and double the figures for Kosovo (980), Georgia (976) and Montenegro (909), which rounded out the top five.
John Morales says
friedfishe, your doltish provocations are not just wrong, but also futile.
(I’d dispute you, but you’re a drive-by poster, so that would be futile too)
Who Cares says
There is a reason that Friedfish had to go back to late January and early February seeing that the current knowledge (late August) is “Ivermectin in doses that aren’t potentially lethal for a human have no effect on COVID.”
Do also note that they deliberately went for a Japanese doctor due to the language barrier, makes it a lot harder to find an in depth explanation.
Do also note that they specifically do not mention what group of patients Nagao gave Ivermectin to. It wasn’t the group on the ventilator, it wasn’t to people on the ICU, it wasn’t even on people requiring hospital care (from what I’ve managed to piece together as non-Japanese speaker). It was on the group that would have recovered on their own without Ivermectin. Worse is that the good doctor didn’t record any of the data that would be relevant with such a group (See how Remdesivir was studied). All the Nurgle cultist has is a press-conference or else said an anecdote (and an anecdote is not data, the plural of anecdote is not data but anecdotes, the plural of anecdotes is still anecdotes).
Finally note the magical thinking in which a single press-conference nullifies all actual studies done on Ivermectin, since not a single study that wasn’t fraudulent has resulted in a positive for the use of Ivermectin.
John Morales says
“Nurgle cultist”… heh. Good one.
“In Japan, illnesses are categorized by a classification system; approaching COVID as a Class 5 illness would mean that it could be treated like a seasonal flu.”
interesting. what proportion of seasonal flu sufferers in Japan end up with iron lungs? is it different? yes? THEN WHY THE FUCK WOULD YOU CLASSIFY THEM THE SAME.
how can people be such idiots and yet think they are doing the world a favor spreading their idiocy? don’t you just want to slap them until their head spins?