We Won’t Get Fooled Again sounds much tamer now than it once did. It was an anthem for the left in 1972 but in this context its not clear who’s anthem it might be. The message of the WHO song is we will get fooled again – see the RxISK We Will Get Fooled Again.
Conspiracies and Cock-ups covered some current views about what is going on in the health domain. It left out one important angle – we’ve seen it all before. MRNA is the new SSRI.
Common to both SSRI and mRNA stories are Contract Research Organizations (CROs) who run the trials, often inventing patients who don’t exist or data on patients who do exist and sequestering trial data.
In both narratives, medical writing companies have ghostwritten the trials, academics have been willing to have their names on papers whose data they have seen nothing of and regulators have been willing to approve treatments on the back of negative studies and to turn a blind eye to publications claiming a treatment worked well when the regulator and company have agreed it is negative.
Very few of those fulminating against vaccines now seem to realise this.
Rebranding
To be marketed as antidepressants, the SSRIs had to be rebranded. These drugs are primarily anxiolytic. Owing to a benzodiazepine dependence crisis, it was impossible to market a new anxiolytic in the late 1980s. As a result, the SSRIs were redesignated as antidepressants. SSRIs are less effective than older antidepressants and completely ineffective for severe depressive disorders such as melancholia.
Good marketing, hinging on our wish to be fooled again, overcame these facts and has obscured the fact that the people primarily treated with these new revolutionary drugs were the people treated with the old revolutionary benzodiazepines. It was obvious in 1990 how things would play out – more people are now dependent on SSRIs than ever were on benzodiazepines.
The mRNA Covid vaccines have also been rebranded. They are relatively ineffective in terms of blocking infection with and transmission of the Covid virus. They did not meet the old definition of a vaccine that held up to January 2021, which was a fragment of a dead bacterium, or an attenuated or live virus, designed to produce immunity. The new definition covers a strand of genetic material used by the body to produce an antigenic substance such as a spike protein – a gene therapy.
Effective or Fooled by Surrogates?
Ordinarily, an antibody response to a viral protein from a virus would be taken as a surrogate marker of immunity.
Changes on depression rating scale scores are surrogate markers of antidepressant efficacy.
SSRI depression rating scale scores do not correlate with effectiveness, with lives saved, or suicidal events, or recovery where recovery means a return to function without having to stay on treatment.
In the case of mRNA vaccines, the production of antibodies does not appear to function as a marker for immunity, as it does in the case of a measles vaccine for instance.
There may be an effect of mRNA agents in that pneumonias seem less likely, with people less likely to die in intensive care units, or people less likely to have coughs and be PCR tested, but these may yet turn out to be a treatment effect rather than a vaccine effect or even a placebo effect.
Wash in – Wash out
In SSRI trials, companies required patients to stop taking pre-existing medication prior to starting on blinded treatments. After abruptly stopping dependence producing medicines, patients entered an up to 2-week period designated as wash-out or run-in, prior to starting active or placebo preparations.
There was a high rate of suicidal events and completed suicides during this two-week period. In breach of regulations, companies designated these events as placebo events and added them to the suicidal events happening on placebo in the trials – in a bid to hide the problems active treatment was causing.
In SSRI trials, there was a 30 day follow up after the treatment phase ended. In some instances, during this period, patients on placebo were put on an SSRI and went on to a suicidal event that was designated as a placebo event.
In Covid vaccine trials, events such as infection with Covid or serious adverse events that happened in the period after a first vaccine right up to 5 or 7 weeks later were not attributed to the vaccine. Patients with Covid or dying from Covid or from vaccines, after the first dose of a vaccine have been routinely referred to as unvaccinated.
There are thousands of deaths now reported in the two weeks after the first dose of vaccine and again after the second dose. On an Intention to Treat basis, in trials these should be counted as vaccinated but aren’t and patients admitted to hospital are viewed as unvaccinated.
The superficial rationale for coding suicides and suicidal events as placebo is that people were not on the trial drug at the time. The superficial rationale for counting deaths post vaccine as unvaccinated is that patients have not at that point developed full immunity and so are unvaccinated.
Disease not drug
Early in a public crisis about SSRIs causing suicide, Eli Lilly, the makers of Prozac, ran an it’s-the-disease-not-the-drug defence.
This defence can be particularly successful when both the disease and drug cause overlapping symptoms such as suicidality, apathy,and sexual dysfunction.
From the start of the Covid pandemic, articles stressed that Covid could cause neurological problems, along with thromboses, cardiac issues and other problems.
These were all highly likely to be reproduced with vaccines that make Spike proteins. Early studies of vaccine related problems have argued that neurological problems, thromboses, cardiac and other problems occur on vaccines but at a lesser frequency than happen in the untreated illness. The general argument has been that whatever has happened you post vaccine, things would have been worse had you not been vaccinated.
Misinformation or Science
When convincing reports of SSRIs causing suicide emerged, companies asked the scientific and lay media whether they were going to believe the anecdotes or the science. Companies and regulators said these are sad cases, but while the earth might appear flat, the science shows it’s not.
RCTs were the supposed science in the SSRI case. It turned out that, behind a ghostwriting of publications and sequestration of trial data, these RCTs showed an excess of suicides and suicidal events on active treatment compared to placebo.
The company argument then became one of claiming that this increase was not statistically significant for any one SSRI in one trial and therefore there was no evidence for a problem. This claim later also turned out to be untrue.
Companies went on to say there is no evidence that SSRIs have any side effects at all. Unless something is shown to happen to a statistically significant extent in one RCT then we have no real evidence to think the drugs cause a problem.
In the case of the vaccines, all evidence of harms is designated as misinformation as these have not been proven to happen to a statistically significant extent in RCTs.
Since then, tens of thousands of reports of deaths, and of neurological, cardiac and other problems have poured into Pfizer, FDA, CDC and their equivalents in other countries, many from doctors making a link to the vaccine. The response from companies and regulators is to say that ‘reports’ like these are expected. There is no evidence of new effects – such as someone turning blue and growing feathers – and so there is nothing to action.
Company use of the term ‘reports’ insinuates they may be from anti-vaxxers or more generally unreliable and of course people cannot be tracked down to establish what if anything actually happened them.
In the case of someone turning blue, or something else new, as in vaccine enhancement of the risk or severity of a Covid infection, there are reports of vaccine enhancement but companies have decided they do not have enough detail as to whether this could be happening or not.
Blood on Your Hands
Those mentioning the harms of vaccines are typically accused of causing deaths.
This is the same as the treatment visited on people raising the harms of SSRIs or other drugs. The precursors of what would now be called social media trolls routinely made wildly over the top statements claiming anyone who was raising harms as an issue would have blood on their hands.
This plays into a widely held wish particularly on the Left – that medicines are sacraments, which can only do good and cannot harm.
Health is the religion of progressives; progressives who want to believe we are moving toward life saving medicines. Many have lost the ability to comprehend the idea that, while done with good intentions, medicine and surgery necessarily involve poisoning and mutilation. It is a problem if either we or our doctors forget this.
In the case of vaccines a host of doctors, often anonymously portray themselves as Morally Injured by the unvaccinated – seeing these as people take up beds in hospital through a wilful refusal to get vaccinated – denying treatment to deserving others in the process.
Intercurrent Disorders
In all clinical trials, there are adverse events. Where these involve death, hospitalization or a life-threatening event, companies are obliged to file narratives laying out what has happened.
In their SSRI trials, companies discovered a loophole in the mid-1990s. If a patient was deemed to have an intercurrent illness, raising the possibility that this pre-existing illness should have excluded the patient from recruitment to the trial, no narrative had to be compiled. In Study 329, a study of paroxetine versus placebo in teenage depression, all drop-outs for intercurrent illness happened on paroxetine and were likely adverse reactions to paroxetine.
In similar fashion, in trials of later vaccines, such as the HPV vaccine for cervical cancer, some patients with postural orthostatic tachycardia syndrome (POTS) or other problems developing after vaccination were designated as intercurrent illness and discounted from the reckoning on this basis.
In the Covid vaccine trials, adverse reactions, particularly neurological reactions have been coded as anxiety states or functional neurological disorder, both of which imply pre-existing conditions. As pre-existing, these events have not been viewed as vaccine-related even when they manifest themselves for the first time shortly after vaccine administration.
In AstraZeneca’s Phase III trial of its Covid vaccine, the published study stated;
“Deaths that were adjudicated as not related to Covid-19 were treated as intercurrent events and therefore censored at the date of death.”
There are vast number of Covid deaths that occur in the first two weeks after the first dose of vaccine. In trials these events are all likely to have been coded as not related to Covid-19 and from the Astra-Zeneca statement above appear likely to have simply vanished. What we don’t know is the proportion of those deaths that happened on vaccine compared to placebo but at present it looks like close to all of them represent vaccine harms.
Concomitants
Recent vaccine trials have compared active treatment with treatments designated as placebo but which in fact often contain elements such as the adjuvants that have been part of the vaccine. It is possible, and seems highly likely, that these adjuvants, especially if there are other proteins in the mix, may have caused reactions masking some of the adverse effects of the active vaccine.
In SSRI trials, people on placebo got serotonin reuptake inhibiting antihistamines, which produce many of SSRI side effects on vision, bowels, and sex, to agitation and suicidality.
The mRNA agents contain mRNA fragments which at present are linked to a multiplicity of effects with death as a common denominator.
Dependence
SSRIs were known from healthy volunteer trials to cause dependence prior to their launch. Within three years of paroxetine’s launch in Britain there were more reports of dependence on it than from all benzodiazepines combined in the previous twenty years.
This prior knowledge made it possible to design trials to conceal this problem. It has taken thirty years for establishment medical bodies to concede that SSRIs can cause dependence.
In the case of mRNA agents, it appears that antibody production wanes over time and may switch in some individuals from predominantly neutralizing antibodies to enhancing antibodies – that is putting people at more risk of contracting an infection than not.
The descent into sequential booster doses of vaccines points to an increasing dependence.
In contrast to vaccine induced antibodies, which belong to the IgG group, the immunity that comes from infection involves IgA and IgG antibodies along with T-cell immunity and is more secure and less likely to put people at increased risk of further infection. Infection makes people more resilient where vaccination, it appears, may compromise resilience.
Similarly, treatment with antidepressants may compromise resilience. In treatment trials, those treated with and recovering on placebo are less likely to relapse in the future than those treated with either antidepressants or psychotherapy. In the case of antidepressants, withdrawal produces a relapse enhancing effect, at least in so far as reinstating treatment is a marker for this.
Finally, there appears to be an overlap between Long SSRI Syndrome – protracted withdrawal syndrome – and Long Covid Syndrome. Rather than investigate the physiological basis for either of these conditions, it seems more convenient for everyone except those injured to view these problems as ‘functional’ which translates as psychogenic or hysterical.
Special Populations
With both SSRIs and mRNAs there have been vigorous efforts to treat pregnant women and children.
In the case of the SSRIs, it was known early on that these drugs caused miscarriages, along with birth defects and behavioural defects like autistic spectrum disorder but this has not stopped physicians and the media from encouraging women against their better instincts to take these drugs in pregnancy.
There is a similarly strong push to get pregnant women vaccinated without evidence to show that this is safe.
In the case of children, 45 of 45 trials of antidepressants in depressed minors have been negative with a clear elevation of suicide risk and risks of other adverse behavioural consequences. Yet there has been an increasingly strong current pulling children toward these drugs so that they are now the second most commonly taken drugs by teenage girls.
There is a comparable push to vaccinate children despite widespread agreement children have little to gain from being vaccinated and run considerable risks.
Real World Data 1
The trials of SSRIs show more suicidal events on treatment than on placebo. In response to these findings, companies turned to Real World Data, arguing that national suicide rates have shown a fall since the introduction of SSRIs proving these drugs don’t cause suicide.
In the case of the vaccines, the lack of lives saved in RCTs and possible harms caused by treatment is countered by claims that Real World Evidence shows the vaccine working well with an overwhelming proportion of those dying in ICUs being unvaccinated. It is now increasingly recognized however that there is a difference between dying with Covid and dying from Covid.
In the case of the SSRIs, it is easy to demonstrate that suicide rates were falling before SSRIs came on stream and this seems linked to a fall in autopsy rates and rise in deaths of undetermined cause.
In the case of Covid and its vaccines, getting data on all cause mortality broken out by age and sex is important and all deaths from 1 minute after a first shot should count as vaccinated in contrast to the current counting all vaccine deaths in some instances up to 21 days after a second shot as unvaccinated.
There appear to have been instructions not to do autopsies in the case of those dying shortly after vaccination. We await good explanations that reconcile the apparent clinical trial and real-world evidence for vaccines.
Real World Data 2
With SSRI treatment the problem of patients becoming suicidal on treatment appeared in clinics after the drugs were launched. These clinical cases showed challenge, dechallenge, and rechallenge effects, dose response effects, a response to antidotes, and convincing clinical narratives that made it certain that these drugs could cause people to become suicidal.
The challenge then was to reconcile this clear evidence of a treatment induced problem with RCT evidence that appeared to argue against this possibility. Investigating this issue brought to light the fact that there was an increase in suicidal events in controlled trials of the SSRIs that was not apparent owing to a sequestration of the clinical trial data and ghostwriting of the medical literature.
There now appear to be a very high number of convincing neurological and other adverse events post vaccine that at first blush appear at odds with the clinical trial literature. One of the scientific tasks ahead will be to reconcile the apparent discrepancies.
This task is urgent because patients with convincing problems are at present being ridiculed and told their problem is in their mind because their doctors appear to assume that, if a problem did not appear in published clinical trials, it cannot be caused by the treatment in question.
A clinical condition, now called post SSRI sexual dysfunction (PSSD), illustrates the issues. Sexual effects happen close to universally after a first SSRI pill but were missed in the clinical trials of these drugs, because the focus on a primary therapeutic endpoint means that problems happening more frequently can be missed. PSSD was in fact reported before the SSRIs launched but still the publication of a ghostwritten literature reporting the results of clinical trials that make no mention of these possibilities mean patients are ridiculed and some commit suicide because of the ridicule.
RCTs focus on a primary endpoint, such as whether this drug has an effect on mood. The focus is so extreme that something that happens to everyone 30 mins after their first pill can be missed – the genitals of takers become numb or irritable. This should be unmissable but was missed.
This numbing not just of genitals but also of reactivity and emotions is a core effect of these drugs, through which they produce any effects they produce on mood.
Similarly, mRNA trials have had an intense focus on whether these agents produce immunity, which appears at best rather minimal. What we know is they produce Spike proteins. The RCT focus was on whether there is evidence of immunity rather than on Spike protein production and what these proteins might do. People it seems have been able to drop dead on the day they received the vaccine without the link to the vaccine being noticed.
Stratagems
In the case of the SSRIs the stratagems used to hide problems included expressing the problem in terms of patient exposure years rather than in terms of patients exposed. This made it possible to keep some people doing well on SSRIs on treatment for extended periods of time, which diluted the problem being caused by treatment.
Other approaches involved unusual coding of adverse events such as suicidality, which has been coded under a range of headings from emotional lability to nausea or burns.
Another stratagem is to break what might be one effect into 6 or more such as agitation, akathisia, anxiety, hyperactivity, nervousness, restlessness or tension.
Or grouping behavioural events with common neurological events like headache or dizziness which make the behavioural events disappear.
A more recently developed strategy seen in both vaccine and drug trials is to use an adverse event tracker app which only allows participants to endorse pre-populated items. In this way companies can exclude things they know might be happening but don’t want the world to know about.
Stigma
If a person with AIDs says they are not taking their Triple Therapy people recoil, as they do if a person with epilepsy says they are not taking anticonvulsants.
Many women can sense the relief settling over a group when they indicate that they are taking an SSRI – this defines them as competent, sensible, and not liable to an hysterical outburst.
The unvaccinated are now treated as lepers even though their likely natural immunity is better for them and others than vaccine induced cover which wanes.
Natural immunity is the counterpart of the resilience that stems from recovering from a nervous or depressive episode without treatment – it reduces the risk of relapse in the longer run. Taking a technology, however, is increasingly seen as the way to contain the original sin of being human.
Placebo or Oedipal effects
The SSRIs barely beat placebo in trials, and likely don’t beat placebo in real-world terms. The availability of SSRIs acted like a placebo for doctors encouraging them to undertake the difficult task of transitioning patients out of the benzodiazepine frying pan.
Psychotropics whether benzodiazepines, SSRIs, or other agents have placebo effects on doctors – relieving them of the stress of wondering..