Vaccine mandates feature prominently in the news at the moment. These are contentious for some health personnel, nurses and doctors among others, who are refusing to be vaccinated and willing to lose jobs if need be.
France and the United States, countries not typically associated with an authoritarian approach, have made Covid vaccines compulsory. Some countries have introduced vaccine passports. Even in countries where vaccine passports are not being introduced, the vaccines are promoted to young people as the passport to a social life – implying that they will be shunned if not banned for not being vaccinated. There are proposals for playgrounds with QR codes in several countries.
Some Australian politicians have openly said that we are heading for a vaccine economy – those who are not vaccinated will not be able to participate. Perhaps they’ll be shipped to an island.
For a light take on this written 8 years ago see Medystopia. Today’s version would see Australia perhaps mending bridges with China by inviting them to build an island in the South China Sea to house the anti-vaxxers. Or with France by doing a deal to house the people soon to no longer be Australian citizens on a French Polynesian island.
The image above is of journalists being detained while reporting on an anti-vaccine demonstration in Melbourne. This probably works because of the contrast between a wispily dressed damsel in distress and knights in armour – even if they’re not about to rescue her.
There is only a small group of people behind RxISK. Everybody, so far as this author knows, is fully vaccinated as are their extended families, including mine – with all vaccines except for HPV in one case and one other exception.
Some people suffering from conditions like protracted SSRI withdrawal have asked us whether the vaccines might be risky for them. There is no good data on this but we have put none of them off getting vaccinated. Many people who have been injured by medicines and have been featured on these pages, such as Altostrata, are enthusiastically pro Covid vaccines.
This post is not going to delve into the evidence for or against Covid vaccine efficacy. The complexities in this area have been handled well by Peter Doshi, a senior editor of BMJ in Decisions without Data as well as in two presentations at FDA Advisory Committees and HERE.
There have been shifts in vaccine confidence in recent years, which have been covered in a recent post Shifting Vaccine Confidence and handled in several books – Maya Goldenberg’s Vaccine Hesitancy (see also Urato Review) and Stuart Blume’s Immunization, which lay out the shifts in how vaccines are viewed without engaging in disputes about whether they work or not.
These references try to find some middle ground rather than take sides. This post though is about taking sides on a problem that at present is going relatively unmentioned.
Needles and Haystacks
Half a year ago we opened up the issue of reporting adverse events to RxISK following a Vaccine – Report Covid Vaccine Effects to RxISK. We didn’t push it, as it wasn’t clear RxISK could do much and has had a lot of other things on its plate. To date we have had some but comparatively few reports.
This dearth of reports could mean that very little is going wrong on vaccines. Except, I and several other people know others who have died shortly after the vaccine, and others again who have been injured.
Those who die clearly are not going to report. Their families are unlikely to report either because the close to universal experience so far from those whom I know who have had pulmonary emboli or heart trouble or other serious conditions has been that doctors pretty well instantly deny that these difficulties could have anything to do with a vaccine – even when the events are widely accepted as being linkable to vaccines.
There are an extraordinary number of reports of deaths to the CDC’s Vaccine Adverse Event Reporting System – VAERS.
Senior FDA and CDC officials give the impression that they take these seriously and are looking for signals of harms but so far have found none.
This is misleading. VAERS is not set up to find problems. It is not clear if those who set it up anticipated that by not being able to find problems, VAERS might become a means of denying there are any problems.
This is even more the case for vaccines than with the equivalent system for drugs.
In the case of both vaccines and drugs, the names of people are removed from reports and neither CDC, in the case of vaccines, nor FDA, in the case of drugs, follow people up to establish whether the vaccine or drug is likely to have caused the problem.
Even though the names are removed from reports of problems on drugs, the hundreds of thousands of reports from tens of thousands of drugs means that proportional reporting rates can be calculated – how common is this problem on this drug compared with the same problem on all other drugs.
Proportional reporting rates throw up what regulators and others call a signal. They give the impression that much much more research is needed to establish if there possibly could be a real fire behind this smoke created by too many people burning anecdotes.
If FDA and CDC had just left people’s names on the reports and called them up by phone they would have been able sort out whether the drug likely caused the problem far better than any controlled trial could – see Clinical Trials are not Safe and People Count even in Trials and finally They Used to Call it Medicine.
If CDC had called any of the pathologists who did post-mortems stating a clear link between a vaccine and death, they could have confirmed that the vaccine can cause a problem. They might have been able to establish that 10% of reported deaths are likely linked to the vaccine and a further 26% possibly linked, as Norway did earlier this year.
The vaccine reports don’t allow the signal detection we can do with drugs. This is partly because there are much fewer vaccines. It is also because the reports of problems on Covid vaccines swamp reports from all other vaccines over the past 30 years combined. This has the effect of washing out all possible signals.
Unless things change, reporting to VAERS is a waste of time. CDC will remain unable to see the haystack for all the needles it is made up of.
In the case of drugs, doctors don’t acknowledge side effects for a few reasons. Their medical insurers tell them never to link a drug they gave to a problem their patient has.
Guidelines only mention the benefits of treatment and steer clear of hazards.
Regulators have approved nothing for treating hazards.
When it comes to adverse events, doctors are increasingly painted into a corner for both drugs and vaccines. They are up against their health service managers, insurers, guidelines, regulators, and increasingly consumers who will trample over them to get the supposed benefits of treatments – even where the evidence for benefits is nil (SSRIs for young people).
It seems invidious to say it but reports to VAERS offer cover to politicians and doctors and others who can convey the impression that the folk in CDC are at it night and day rigorously analysing the reports that come in to them and at the first hints of a problem will press pause – so we can all take stock.
CDC folk are supposedly are the experts and so for even a doctor to say there are or might be problems before that would be plain unethical. In fact, its the other way around. CDC, and FDA and all bureaucrats depend on professionals to make these judgement calls – this is the essence of professionalism – although fewer and fewer doctors seem able to make the judgement calls needed.
The political imperative seems to be to downplay any mention of any problems and hype the benefits.
This transformation of something in the real world into a sacrament (something that can only do good and cannot harm) is a role usually taken by pharmaceutical companies, helped by wearing the right Vestments (Guidelines) and burning the incense of regulatory approval.
The consequences seem to be a loss of trust in Public Health Systems who now, astonishingly, seem to be less admired and trusted than pharmaceutical companies.
Getting back to the real world isn’t easy. In the case of drugs, which governments don’t promote, pharmaceutical companies are legally obliged to consider any reports of problems and work out if their drug caused it – which they do and sometimes change their drug labels to hint that Zoloft or whatever might cause X or Y – even when the doctors who gave the drug say there is no link and even though companies might open themselves up to legal liability. Companies do this usually when there is no way to explain things other than their drug caused it.
Having said that some companies (GSK), if faced with a compelling case their drug can cause a problem have tried claiming that if the problem hasn’t been shown to happen to a statistically significant extent in a randomized controlled trial (RCT) then, however convincing the case, its a matter of deceptive appearances. This is like saying there is no evidence that alcohol makes anyone drunk. Ludicrous though it is, the argument works with lots of experts and regulators and politicians.
Governments aren’t going to attempt to assess causality, especially in this case as they rather than companies are liable.
What this totally foreseeable scenario suggests is that we should have had mandatory reporting of vaccine adverse events and mandatory assessments of causality – before we mandated the giving of vaccines.
To make reporting work, people who are injured, or relatives of those who have died, need to leave their names on the reports and indicate a willingness to be examined and cross-examined (CE).
The wounds and deaths linked to the vaccine are a huge source of distress but equally great is the silencing and gaslighting health and media systems currently inflict on those who have been injured or the relatives of those who have died. Difficult to see how Joe – may god protect our troops – Biden can support this.
Several sites have made important steps forward in this area:
C19VaxReactions – this is based primarily in the US and
VaxTestimonies.org – which is based in Israel.
Nomoresilence.world – which is UK based but features stories from everywhere.
Earlier this year Katinka Newman did something similar for antidepressants with Antidepressantrisks.org.
These need strengthening with featured people committing to being examined and open to being cross-examined. The CE word brings most people out in allergic bumps but this is critical to credibility.
Anyone – a doctor or pharmacist – doing an examination or cross-examination would need to leave their name attached along with details of their background and also indicate a willingness to be cross-examined in turn as to their conclusions. Those in the firing line should be free to record the cross-examination. If we end up with no-one willing to cross-examine, this will speak volumes in its own right.
Establishing causality in medicine is a judicial process undertaken by people with names.
Leaving names in place and inviting examination and cross-examination means the reporting cannot be to VAERS or EMA or any regulatory body, who are obliged by current rules to remove all names in the interests of patient confidentiality. This act, which is invaluable for the pharmaceutical industry, transforms reports into anecdotes or hearsay.
Unless governments get a grip on the mistake they are making in anonymizing reports, the reporting will have to go to an independent body.
Leaving your name attached should not raise confidentiality issues – in that you are revealing nothing about any other medical issues. You were essentially a healthy volunteer when you went for the vaccines. You are now reporting on the outcome of a risk you took hoping to benefit family and friends and your country. By definition you have been pro-vaccine and patriotic.
To make the cross-examination useful, reports need to be as comprehensive as possible. They also ideally need to be accompanied by a print-out of a medical history (or some record of a deceased relative’s history – perhaps an autopsy report). This would clearly remain confidential but would need to be seen by anyone examining your account of what happened.
Anyone examining an account of what happened ideally should also leave a report on their background and credentials for interviewing you.
This process will not establish how many people are injured by or die after a vaccine but it will make very clear that there are linked injuries and deaths. Once this happens, and pro-vaccine patriots do not feel they are been gaslighted, we can work out a way to estimate the frequency with which some of these problems are likely happening.
Ideally this process should be picked up by family doctors whom people should be able to go to and expect to be met by sympathetically. Some of these doctors will be very quick to note any hint of threat or hostility from you, but completely miss their own threatening and hostile demeanour, and all too aware of threats from above to court-martial them if they don’t stay onside and rule out any link between your injuries and the vaccine. See Patient Experiences reporting Adverse Events.
Pharmacists may be better suited to a job – that ultimately risks putting low-salt doctors out of business – For low Salt see Can Doctors Save their Jobs and They Used to Call it Medicine/Girl Who Eats Salt.
Mandates like these would put us all in a better position to judge the validity of mandatory vaccination. The absence of measures like these (and some other measures) makes it more difficult even for those who are pro vaccines to support mandatory vaccination.
Since the above was written, the US group running the harms website above have established a research website – because, as they said, no-one else was doing anything.
It should not need noting but this is a pro-vaccine post and site. It is dealing with issues that pro-vaccine people have had. No-one who is anti-vaxx has made any contribution or could make any contribution to the points raised here.
More next Week.