This post follows last weeks The Evidence that Counts for FDA. The image of dog or bear in a burning house with an untested fire extinguisher is one that many medical managers have used when referring to the Covid crisis and vaccines – the vaccines may not be perfect but we are in a burning house and even if untested they are better than nothing.
Thanks to the College of Physicians and Surgeons of Ontario for this idea, who told me an image showing this was circulating widely on the internet – this was 5 months ago. If anyone can find the original image please send – it might be apocryphal or an urban myth.
In 1962, when the current regulatory system for medicines was put in place, every one knew the regulators were bureaucrats, primarily concerned with establishing a paper trail to support the licensing of a drug. A license permits a medicine to be prescribed and certain claims to be made.
The role of a regulator is to ensure that drugs, just like butter or other foodstuffs, and words like organic or artisanal, meet certain criteria. Regulators do not offer views on whether drugs or butter are good for us or whether this vaccine or that chocolate is a good vaccine or good chocolate, or the use of the word organic meets general understandings of what that word means. [The mRNA agents did not meet dictionary definitions of vaccines; the dictionaries were updated].
Regulators are not scientists, clinicians, investigators, or public health officials. It is not their role to think, other than to think about whether something conforms to a previously established template.
Around 1962 and for three decades afterwards, while regulators licensed medicines, physicians, not regulators, evaluated them in practice and established what other effects these medicines might have. Physicians were viewed as the most important part of a broader regulatory apparatus for these unique products that were available on prescription-only.
Regulators followed a developing consensus among clinicians in respect of evaluative methods or harms, embodying them in rules. Clinicians, for instance, told them RCTs were a good idea – not the other way around. Regulators did not tell clinicians how to do their job.
A medicine has two parts, one chemical and the other information on how to use that chemical. The chemicals are mostly inorganic and unsafe. All medical and regulatory systems explicitly view the chemicals used in medical practice as inherently and unavoidably hazardous.
The dominant medical wisdom was that giving these chemicals necessarily entailed risks. Even if the intention is to bring good out of the use of a chemical, giving such chemicals is an act of therapeutic poisoning and the patient might well end up poisoned. The information component of a medicine aims at managing those risks as best as possible.
Anesthetics, for instance, regularly kill people going for surgery. We give them in the hope that while using them we can bring about other changes that will be of benefit – and we tell the patient there is a risk they won’t wake up.
Two hundred years ago, Philippe Pinel said that it is a great art to be able to use medicines to good effect, but an even greater art lies in knowing when not to use them.
Phrases like the art of medicine now conjure up a contrast between soft clinical interviews and a hard science which for many means randomized controlled trials (RCTs).
RCTs hinge on quantification and algorithmic processes. These can give an appearance of objectivity in contrast to which a clinical interview with someone reporting an adverse event on treatment might appear subjective. Good interviews are all too likely to be seen as an art rather than a science.
After interviewing people and investigating their report of a harm, up to 1990 clinicians routinely wrote up their observations and conclusions in articles which were published in medical journals in the form of case reports. These came with the names of the clinicians attached and today may often have the patient’s name also.
In 1991, a crisis blew up about SSRIs causing suicide. The company response to compelling case reports that these drugs could cause suicide was that these unfortunate cases were anecdotes (today’s misinformation) not science. See Where Does the Misinformation Come From,
In response, companies produced the appearances of analysing their RCTs and on this basis claimed that the science showed there was no problem. Companies challenged the public, politicians and the legal system to decide whether they were Going to Believe the Science or the Misinformation. See Vampire Medicines
This 1991 clash was not between Hard Science in the form of RCTs and a Soft Art in the form of Good Interviews, that gave rise to Misinformation. It was a clash between Fraud and what I am calling here a Judicial Process. This choice of words is explained below.
As outlined above company RCTs are close to fraudulent. The fraud is not readily checked as there is no easy way to establish what actually happened to people in these trials. When the records are accessed, it turns out that there were people in the RCTs to whom exactly the same hazards such as suicidal events or sexual dysfunction happened as doctors later reported in the Case Reports. More trial subjects had these events than were prevented from having such events by treatment.
The scale of the problem happening in these RCTs was obscured by egregious company manoeuvres, several of which breached FDA regulations. FDA noted but turned a blind eye to these breaches.
Words like fraud are emotive. The key point is that RCTs are not ipso facto science and case reports are not ipso facto non-science or misinformation.
Company RCTs are better viewed as Assay Systems – a set of maneuvers designed to get their drug or vaccine approved. These are not exercises aimed at exploring the effects of or best use of a vaccine or drug.
A lot of Science, and even more so Assay Systems, comes bedecked with the appearances of quantification and algorithmic processes which the laity see as untouched by potentially biased human hands. But quantification and algorithms are not the hallmarks of science.
Science has rules of evidence and requires judgements, verdicts, diagnoses. These judgements are ordinarily provisional and come with a requirement to be reviewed should new evidence emerge.
When it began around 1660, science distinguished itself from philosophy and theology on the basis of a requirement to explain observable events in front of individuals, without appealing to matters that could not be settled by experiment. The beliefs or biases of Christians, Muslims, Jews and Atheists had to be left outside and there was no leaving the room until a consensus was reached – other than to do further experiments.
Forty years before these ground rules laid the basis for the Royal Society and science, the British legal system reached a similar conclusion as regards Rules of Evidence for legal trials following the execution of Walter Raleigh. Raleigh had been convicted on the basis of hearsay. After his execution, the new Rules meant that cases could only be decided on the basis of the testimony of witnesses who came into the court to be examined and cross-examined. A verdict as to what the observable testimony supported required unanimity among 12 people with differing backgrounds.
This approach to Rules of Evidence is shared by Science and Judicial Systems. It better characterizes Science than any adherence to quantification and algorithms.
The term judicial process here means a process of interrogating observable data that culminates in a judgement. The processes of science are judicial in this sense.
When done properly the construction of a case report about a hazard or other novel effect revealed by the use of a medicine is similarly judicial (in the sense of weighing evidence and coming to a verdict/diagnosis) in its approach and as rigorously Evidence based as anything in medicine’s ancillary sciences.
In judicial settings (whether legal or clinical), a rigorous approach to Rules of Evidence shape the observables that jurors, judges and clinicians face. This does not mean that the right answer is supposed to arise magically from the observable data. Clearly there is a need for insights that grasp the possible relations between the observables and judgements as to which of the possible relations is the most probable. These judgements are called verdicts in legal settings and diagnoses in medical settings.
In both legal and clinical settings, verdicts can be shaped by the credibility of experts and witnesses. This might appear problematic from a scientific point of view, but this potential bias is as nothing compared to the systematic bias that stems from abandoning judgement altogether, which has led to an effectively fraudulent medical literature.
Without verdicts and diagnoses, we know nothing. Algorithmic processes, ratings scales for behaviour that preclude judgement calls as to whether a disease or its treatment has led to suicidality, and statistical processes are inherently meaningless.
The crisis with the SSRIs and suicide however led to an abandonment of verdicts. Lilly appeared to prevail in the case of Prozac and suicide in 1991, and while the company’s success on the issue of Prozac and suicide has been completely overturned, its legacy is a widespread belief that the only form of knowledge in medicine that counts comes from controlled trials. In legal settings, this is the central plank of company presentations to Daubert hearings in cases involving treatment induced injury or death.
After 1991, medical journals became scared to publish case reports of treatment induced hazards. With the changed landscape, they worried about being sued by pharmaceutical companies for publishing something companies could claim was misinformation. In addition, journals made far more money from publishing RCTs and analyses of these trials, which were bought by companies for marketing purposes, than they did from case reports.
Given the difficulties in getting published, the only place for doctors to report was to regulators. This made no sense in that regulators have no experience in or training in determining whether a drug or vaccine might have caused a problem. The regulators of drugs are concerned with the wording of adverts only. They turn a blind eye to fraudulent scientific publications but quibble over claims made in adverts.
In respect of harms reported to them, regulators do three things.
This is striking in the case of Covid-vaccine related death reports which outnumber reports of deaths from all other vaccines over several decades twenty-fold. These deaths congregate in the first two weeks after a vaccine is administered, many in very healthy people.
If a wife shoots a husband, it is possible that in one case out of a hundred he died from a heart attack just beforehand. An autopsy might help us with this. But we feel pretty comfortable coming to a verdict as to what happened even without the autopsy. Doctors however have reached a point where they seem inhibited in making a diagnosis in a case like this that even a 12-year-old could diagnose.
Given their diagnostic faculties in respect of harms have remained unused for three decades, doctors may have lost this ability, but in failing to make diagnoses and make them public, doctors have abandoned their birth right, as much as any judge or lawyer would were they to advocate abandoning jury trials in favour of algorithmic processes.
The vaccine or drug-related harms that doctors witness in their clinics can be investigated in a scientifically appropriate manner. A doctor’s investigation and diagnosis, especially when replicated by others, is better evidence about how best to practice than anything that comes from trials run by Contract Research Organizations (CROs) whose data is concealed by force majeure and a selected proportion of which appears in ghostwritten publications that hype the benefits and conceal the harms of treatments.
This latter material, that today parades under the banner of Evidence Based Medicine, should not get in the way of a doctor being a scientist and following the only evidence they or anyone else can follow.
While doctors continue to fail in their duty to establish the harms of treatment and communicate information about these hazards, they further compromise the ability of any of us to give informed consent to treatment. They have lost their salt as doctors and the profession risks going out of business unless this changes – See Can Doctors Save the World – and Their Jobs.
A medicine is a chemical that comes with information. Drugs and vaccines are chemicals and, as that word connotes, they are hazardous to put into the human body. The information that comes with these chemicals is what makes them medicines. The chemicals will always be hazardous. In recent decades the information has been degraded and now poses an increasing threat to any of us who take any on-patent medicine.
This degradation has underpinned a pandemic of overtreatment that has led to falls in life expectancy in Western countries even before Covid struck.
It is important for the common good, even more than for individual liberties, to question vaccine mandates, which risk entrenching the very factors, the fraud, that has led to this pandemic of overtreatment.
We might board a spacecraft and leave earth to escape a deadly virus if we were confident it would take off and land safely. In this case, the Pfizer and Astra-Zeneca vaccines have a track-record of blowing up on lift-off and we still don’t know if they can land. In these circumstances many reasonable people might prefer their chances with the virus.
Patients with a problem that might have stemmed from a vaccine or drug come to a doctor for help. The first step in helping is a diagnosis/verdict.
The ability of a patient to get a fair hearing has been severely compromised since 1991. For instance, although the commonest effect of SSRIs is on genitals and sexual function, and even before these drugs were launched companies had healthy volunteer and other evidence that sexual dysfunction might endure after treatment stopped, the RCTs that brought these drugs to market indicated that enduring problems were non-existent and other problems were rare and would clear when treatment stopped.
As a result, 30 years later clinicians dismiss patients who bring them problems of enduring post SSRI sexual dysfunction (PSSD). It took close to two decades before reports of these problems reached the medical literature and this only happened because some clinicians reported their own PSSD, albeit without making this clear.
If a problem, like PSSD, does not appear in the supposed Evidence Base, patients are told their difficulties are in their mind rather than stemming from a prior medicine – how could a drug that has been out of your body for months still be causing this? Ridiculed and dismissed like this, some people have committed suicide. This blatant miscarriage of the clinical process strongly suggests to them that nobody is doing any research on PSSD or possible cures for it.
These miscarriages of justice continue to happen even though PSSD has now been written into the label of these drugs. The ‘recognition’ appears in a part of the drug label that nudges most clinicians to translate this mention as ‘we have also had reports from flat-earthers and anti-vaxxers – make of them what you will’.
What pretty well no doctors know is that mentions like this only happen when companies have cases that even they can only explain in terms of the effect of their drug – or when they hope to phase out their drug in favour of another more lucrative product.
It is little exaggeration to say that a Nobel Prize awaits someone who can establish how SSRIs bring about PSSD. A cure would both save lives and open up ways to engineer new treatments which taken in short courses could have enduring beneficial effects – rather like the effects of mRNA agents.
PSSD is a dramatic example of what is now the norm. Death and disability from medical treatments is now our commonest cause of death and disability. This stems in part from a failure to recognise that treatment can harm, a failure to recognise that having people on multiple treatments is even more likely to harm, and a failure to appreciate that this is an inevitable consequence of tolerating a ghostwritten literature with lack of access to trial data and entrusting bureaucrats to keep us safe rather than doctors.
For this to change, doctors need to realise that the judicial processes they conduct, and the verdicts they come to, are more important to justice for their patients than any steer from a government or regulatory apparatus – See They Used to Call it Medicine.
In the case of vaccines, it is very clear that healthy people, many of them enthusiastically pro-vaccine, as well as others driven by fear of the virus or losing a job, are being killed and seriously injured by these mRNA agents. When injured they meet medical systems and personnel who ridicule them and tell them their problems are in their mind or the pain in their chest is a sign that the vaccine is working.
Doctors and nurses have lost jobs for linking injuries and vaccines. This inhibits others from doing so and blocks the possibility of early diagnoses that might encourage research on these injuries and lead to treatments that might minimize disability and prevent deaths.
It now appears to be the norm for doctors facing a patient with thrombosis, myocarditis, peripheral neuropathy or other problems following a first dose of a Covid vaccine to refuse to endorse an application for a medical exemption from the second dose. In this case, the doctor is de facto denying a causal link to treatment. Its a bizarre abrogation of the role of a physician.
If a doctor writes a letter supporting an exemption, this will ordinarily be turned down by another person in the system, commonly working in public health, who has never met and will never meet the injured person and will almost certainly have less medical expertise in managing that injury than the person supporting the exemption.
Over the past three decades, the encroachment of a fake literature paraded as gold standard evidence has produced soft mandates that have eroded the likelihood that patients will get justice in clinical settings for injuries stemming from SSRIs, statins for cholesterol, bisphosphonates for osteoporosis, other drugs used to manage risks, and the mRNA agents now designated as vaccines.
The addition of hard mandates for these mRNA agents can only make things worse.
The argument outlined here is not based on the rights of individuals to bodily autonomy. It speaks to the wider rights of all of us to the benefits that stem from all of us co-operating in accordance with the jointly held values that are embodied in what we call science and justice.
|Trial Data Inaccessible||Yes||Yes|
|Regulators Approve on Basis of Negative Trials||Yes||Possibly|
|Harms Hidden under Misleading Codes||Yes||Yes|
|Harms Hidden under Patient Exposure Years||Yes||Yes|
|Harms not Collected||Yes||Yes|
|Harms Hidden using Simpson's Paradox||Yes||Yes|
|Harms not Collected as Autopsies not Done||Yes||Yes|
|Harms labeled Misinformation||Yes||Yes|
|Blame the Disease Strategy||Yes||Yes|
|Treatment linked Death & Injury added to Placebo||Yes||Yes|
|Post Treatment linked Death and Injury Added to Placebo||Yes||Apparently|
|Placebo Patients given Active Treatment||Yes||Yes|
|Real World Evidence to counter Negative Trials||Yes||Yes|
|Lose Job if Stop Treatment||Yes||Yes|
|Life Expectancy Falling||Yes||Yes|
|Rebranded From||Anxiolytics||Gene Therapy|
|Harms vilified in Progressive Media||Yes||Yes|
|Efficacy glorified in Progressive Media||Yes||Yes|
|Stigmatization of the Untreated||Yes||Yes|
|Harms vilified as||Scientology Inspired||Anti-Vax Inspired|
These two posts will hopefully be supplemented by another next week – Who’s Afraid of Science.