A Star is Born
What we want when it comes to illness, and desperately so in pandemics, are silver bullets – cheap, safe, effective, easily manufactured drugs with no side effects, ideally already in wide use. When COVID19 came along, Hydroxychloroquine was the first to claim the mantle, but was soon found to do more harm than good. Next in line was Ivermectin! Some interesting theory and rushed research later – A star is born!
There have been sensational claims for the effectiveness of Ivermectin, a drug effective against a wide range of parasites and with some anti viral activity at high doses in the lab.
For some it seemed worth exploring, for others the lack of biological plausibility meant it was not worth examining at all. Some of the early results from a scattering of trials and subsequent meta-analyses were literally too good to be true, yet opinions were invested in, and attitudes entrenched which led to politicisation of the debate.
Entrenched positions were dug by proponents like the FLCCC who heavily publicised the early studies and saw the motivation for any bad news on Ivermectin as inevitably caused by an alliance of Big Pharma, Big Government, Big Finance and their chums in the media wanting to milk the pandemic for profit. Many of them made names for themselves in the public eye, became social media heroes, and lost their jobs in hospitals not prepared to go along with their unproven multi drug approach to prevention and treatment. A typical David vs Goliath, with natural sympathy for Davids milked; heroes and enemies were created.
July 21st was World Ivermectin day – I kid you not!!
So needs must! That was the claim of proponents of Ivermectin and a cocktail of other drugs for Covid19 – standards of research must be lowered to identify and bring into rapid use medications which have potential to help a genuine, rapidly evolving emergency. On the surface it may sound appealing, but how did it turn out?
Opening up pre-print servers meant anyone could publish just about anything in professional looking on-line formats. This has the advantage of getting ideas out there for debate, but also led to a snowstorm of poorly designed studies, lacking the filter of peer review, which were open to misinterpretation and exaggeration, particularly in the public domain where the dull and complex nuances of statistical accuracy are far from the readers mind. In one analysis of 26 trials conducted by volunteers with a track record of exposing bad science, 19 had serious error or fraud. Positive, widely publicised results of pooled trials were shown to be heavily biased by many unreliable studies.
Much was made of associations which had nothing to do with causation.
For instance, in one trial, a Brazilian doctor asked for volunteers from the health sector to take IVM, and compared them to those who didn’t – an unblinded, uncontrolled trial of two very different groups of people and led to claims of IVM’s effectiveness that a child could see through, but nonetheless made global headlines. One of the main meta-analysis findings were when such flaws were uncovered.
In Mexico, pandemic kits containing masks, a pulse oximeter, azithromycin, aspirin, paracetamol were offered to citizens with mild COVID19 and then followed up and those who accepted compared to those who refused. Those who had the kits were over half as likely to be admitted – again, great headlines! Yet, there was no placebo, no randomisation and incomplete follow up, 40% of those not taking the kit were not contactable.
While admiring the effort of the authorities trying to do everything they can, there is the ethical question of knowing the causes of the any differences in outcome will be impossible to disentangle and lead to more confusion. People who said no to the kits are a a different group from those who said yes, and which component, or combinations thereof made the difference? How much harm was done by large numbers of people taking the drugs with known side effects, not to speak of antibiotic resistance?
The implication of the results would be to roll these kits out globally, and would be absolutely wrong.
A jail in Arkansas is being sued by four inmates who had severe side effects from high dose IVM given without their knowledge.
Further spurious claims were made for the effectiveness of IVM from Uttar Pradesh, IVM enthusiasts associating ministerial comments allowing its use with the falling wave of Covid19, again leading to great headlines based on fallacies.
As time went by the case for IVM got weaker. On the one hand, retraction Watch now lists a growing number of papers on IVM, published in pre-print servers which had then to be retracted due to error, poor methodology or fraud. On the other hand, when randomised controlled trials were performed, IVM was found to be ineffective in or out of hospital.
The IVM saga offered several big lessons when it comes to the pandemic and more.
Garbage in, garbage out.
The first has to be on quality of research and how it is controlled. Low quality studies give low quality results but can yield sensational headlines. Conversely, high quality studies which give negative results are often unreported. An example of this was a small preliminary study of the effect of Omega-3 supplements given to children with behaviour problems – the positive results made lots of front pages. The much larger, more comprehensive ensuing full trial left no doubt that the supplement made no difference at all – and not only made no headlines but was not reported at all. The problem then is that millions are left believing the false notion that you can improve complex behaviour with fish oil.
Trials which are underpowered or conducted badly will lead to at best unreliable and at worst plain false results.
There is a serious question of ethics here. What is the point of research which cannot answer its own questions?
The successful development of vaccines shows that when money is no object, well conducted trials can be performed rapidly and the pandemic has shown that long pipelines in deployment of good medicines can be shortened considerably. The Recover, Solidarity and Together platforms showed how effective and ineffective treatments can be identified and integrated into care at speed. Perhaps next time, potential treatments like IVM could be looked at earlier, though for the platforms, it was some way down the queue of potential treatments.
Being Utopian for a moment, perhaps Government could commission medical research, performed in Universities to find out which treatments works for what, and then put the contract out for drug companies to competitively bid for. Looking at Pfizers obscene profits, this could eventually save money, time and ensure research is directed to what is needed by humanity rather that the next anti-impotence drug, baldness treatment or the endless list of “me-too” drugs where treatment already exists. Thats another story.
For many, and completely understandably, trust in politicians, drug companies and the media are at a low ebb. Most recently, Boris Johnson has shown scant regard for truth and any claim for anything must be taken with a huge pinch of salt. Neoliberalism fuelled by world leaders since Thatcher and Reagan has meant that right wing and authoritarian politicians are effectively funded by corporations and are now happy with the impotence of voting to make a real difference. Voting has less appeal as a way of changing things.
The other main feature of the IVM debacle is trust, specifically, its lack.
World leaders from the UK, China to South America are not to be trusted. Much of the media, TV, printed and social are of terrible quality and loaded with vested interests.
However, there might be babies in the bathwater when it comes to assuming that everything that comes from drug companies or regulatory bodies is tainted. This is certainly the case in the US, where attitudes to IVM are strictly partisan, mirroring attitudes, it has to be said, to just about any serious issue, most recently the imminent overturning of reproductive rights orchestrated by religious extremists on the ground, and Trumps three supreme court appointments. If that’s not systemic corruption, I don’t know what is.
In this sense, good old IVM is the ideal hero for those whose thinking is dominated by suspicion.
A cheap, widely used drug, with ‘no side effects’ soon became the golden boy, particularly of the American right and anyone who wanted a simple answer to a complex problem. Any unfavourable comment or science becomes suppression of IVM and answered by accusations of being in the pocket of Bill Gates, Big Pharma, the corporate world and thus corrupt, heretic indeed.
All those pesky government restrictions of freedom – otherwise know as effective public health measures, expensive new drugs, and of course vaccines, were the manipulated evil behind the shining armour of the wonderful IVM. This needs to be understood as much of the suspicion is understandable, but lacks discrimination between that baby and the bathwater.
Another question is how much effort and cash has been spent on IVM (and HCQ) research? Too much is the obvious answer. A couple of well conducted trials might have been done earlier, but many were not convinced about its case. Those done subsequently tanked.
Then there is the hype about IVM’s low cost. Yet, it seems in the US, the cost of IVM to insurance companies is estimated to be $127m annually. This does not include the cost of dangerous delay in treatment or avoidance of vaccines in those who buy into the supposition that IVM works, which it clearly doesn’t.
Why this matters.
When you go to the doctor you go because they are likely to know something you don’t, are able to access the information needed to help and to prescribe, refer or admit depending on need – you need help, and we need your trust. The Oxycontin story shows that this is not well earned and that culture as well as straight corruption can mean that care is needed on both sides of the table. Prescribing drugs is always a balance, some will be harmed, but more should be helped. Patients should expect more than prescribing drugs in hope rather than in expectation and for this reliable studies of new interventions are needed before prescribing.
Further, another pandemic is completely inevitable, assuming we don’t blow ourselves to smithereens first. Next time we should do better.
Platforms such as the RECOVER, SOLIDARITY and TOGETHER will I hope swing into action early with well conducted trials to give solid answers to questions asked by those at either end of the prescription pad, and the whole IVM controversy would be avoided. Masses of time, energy and resources wasted on low quality trials would be avoided, doctors could get on with their work, and as many patients as possible cold get on with their lives after evidence based treatment.
Of course, antivirals generally are not straightforward. Remdesivir is barely effective, Molnupiravir is a poor bet, and now there are big uncertainties about Paxlovid. Despite being very effective in preventing hospital admission in the vulnerable unvaccinated, benefits for those more unwell or vaccinated is unknown.
That hasn’t stopped the UK spending a whopping £2billion (about the most we could expect to raise from windfall taxes on the deadly fossil fuel companies), on stockpiling the drugs, including a staggering 2.75 million doses of Paxlovid. There are uncomfortable echoes of the Tamiflu fiasco where huge stockpiles of a useless drugs cost the taxpayer £600m, sat on shelves until the expiry date went by.
Pfizer profits and shareholders dividends are simply unacceptable, yet not only accepted, but encouraged. Is this is another huge scandal in the pipeline?
Freedom of speech vs responsibility
For many of the worse medical offenders there is a payback brewing which will of course lead to yet more polarisation, particularly in the ‘two nations’ USA. In California, they are considering laws to remove the licenses of doctors who criticise or refuse to prescribe effective treatments and who thus create harm.
This can of course be looked on two ways – the first is that freedom of speech is sacred, but doctors also have a responsibility to reduce harm – and the anti-vaccine movement continues to create significant unnecessary illness and death.
Of course there are grey areas open to debate, but when the consensus is arrived at and vaccines shown to prevent illness, or that a medication is useful, then advising against them must be assumed to increase risk of harm and doctors should not be in a position to do this. As citizens they can, but not as licensed doctors.
I am astonished at what some media savvy doctors in the US are able to get away with. Perhaps other states will follow California, perhaps they will be all the states not preparing to make abortion illegal and cause direct harm and death for women. The politicisation of medicine again.
Patients have a human right to receive balanced, verifiable information from those who they trust by virtue of their qualifications and there must be boundaries which for me, antivaccine doctors leap well over. Pilots are not free to have a quick drink before a flight. Freedom is a relative concept. For instance…..
Recently Joe Mercola, one of the leaders of the US antivaccine movement posted on the theoretical merits of IVM for treating cancer, claiming that: “that the “war against cancer” has been ongoing for decades, with little to show in terms of lives saved.”
That is not my experience or the experience of millions of cancer survivors who have gone on to lead their lives after successful treatment for cancer. He goes on to highlight some interesting research which hints that IMV may have some activity against tumour cells in the lab, echoing its antiviral effects against COVID19 in the lab which did not translate to clinical effectiveness. It’s one thing treating cells in the lab, another treating solid tumours in real human beings.
Sure, the post is couched in the usual legally savvy language of “may” and”potentially”, but stating the cancer treatment have little to show is a dangerous comment. If a reader with cancer – and Mercola has plenty of gullible readers – decides to go out and buy some IVM, whose effectiveness is totally unexplored on living human beings, instead of getting prompt cancer treatment , then that is directly doing harm to those who trust him and at a minimum should not carry the authority of ‘medical’ advice.
Freedom of Speech is important, but Doctors should do better than this. If I was in California, I would be voting in favour of the law. Of course, then Mercola would become a martyr as well as a hero and would, Trump like, enhance the adoration of his followers, but might permit some to see the weak foundations for much of his pronouncements.
Of course, politics and money don’t go together well. An extreme example, perhaps the most extreme, is the Global Warming Policy Foundation, a well funded fossil fuel lobby group which aims it to oppose Zero Carbon initiatives. Despite being totally anti-science (and even survival) they have considerable influence in the US and now over here. Unbelievable! Lobbyists now have more influence that voters.
Part of the IVM sage is a reaction to our own impotence in the face of the dominance of our democracies by corporations, finance and their media chums, and played out in the confidence trick of Trumpism, Johnson and others. It seems appealing and plausible that a simple cheap solution to the misery of the pandemic was just ignored, but the real problems go far deeper; the end of democratic power to effect real change. Frustration, anger and impotence found, for moment at least, a distracting champion. If only it were true.
There is a lot more data than wisdom!
Ideally, data is meant to lead to information, information to knowledge, knowledge to wisdom, and wisdom to helpful action.
The IVM sage hints how far from that we are.