This post asks anyone taking any Covid vaccine to report to RxISK using a RxISK Report if an event or condition occurs soon or some time after a jab that might be linked to the jab.
You will need to specify just which vaccine you have been given and the dates of the first and second shot. The RxISK report form is not ideal for this. Please make the best job of it you can. Please give as much detail about any event or conditions as you can – fill a page if need be.
There is a very brief history of vaccine adverse event related issues HERE.
Several vaccines are now being rolled out to help contain Covid 19. It is not clear what we can expect in terms of hazards.
The trial data has not been made available for scrutiny. It is almost for certain the regulators have not seen the data. They will have seen reports prepared for them, with appendices containing figures and may even have notional access to files containing the results of examinations, questionnaires, and tests administered. This is not the data though.
People are the data. Having data means being able to interrogate it. Without the ability to check if the people behind the paperwork actually exist and if the event that is recorded as happening to them marries up with their understanding of what happened them, we don’t have access to the data in the sense that science requires.
With the HPV vaccine, and in most recent drug trials, the paperwork has people dropping out with the drop-out coded as intercurrent illness or something similar. This is a coding trick industry discovered two decades ago that lets them get away without filing a detailed report on whatever it was that happened to the person in the trial.
In the case of Study 329 for instance one teenager dropped out as having an intercurrent illness. A bipolar disorder. He had gone ‘manic’ – he was waving a gun around threatening to shoot people. If it was coded as a drop out because of hospitalization (he was hospitalized), or as a serious event (the police were involved), the company would have had to give a detailed description of what happened at the time of the event and after.
This kind of hostility happened to healthy volunteers when they took paroxetine and sertraline. It is almost certainly caused in all or most of these instances by a combination of the disinhibiting and agitating effects of SSRIs.
Following the person up to see what happened after he stopped the drug or months after the vaccine is the only way to work out what happened.
Serious problems on HPV vaccines appear to have disappeared down this intercurrent illness plughole.
No-one in FDA, EMA or MHRA is likely to have chased up any of the HPV vaccine subjects or is likely to check out Covid subjects. There is no scientific or clinical reason why the rest of us couldn’t see the data down to the names of people in the trial – these people had no medical condition to begin with.
There are business reasons though why we cannot check things out. It’s good for business to be able to claim “the science shows…”
The science doesn’t at present show and likely won’t ever show whatever it is companies and governments claim. This doesn’t mean company or government claims are wrong – it means it’s not science. This point is lost on journal editors and others who publish business claims in medical journals, alongside their other adverts.
The labels/inserts/Patient information Leaflets and related materials for vaccines that have been published contain lists that appear to give some information about hazards. But few doctors or nurses know how to interpret these materials and accordingly will not be able to brief any of us who ask about things companies concede might go wrong.
For instance, on drug labels, there is a section for other reports which most clinical staff and likely most of the rest of us read as reports sent in by Flat-Earthers and anti-vaxxers. We see companies as being wonderfully transparent including even these in the label and of course we are not going to believe that these things are caused by a drug or vaccine.
In fact, hazards only get into this section when companies have done their damnedest to explain an event away. Left with only one option that their drug has likely caused it, they include mention in this part of their label. Goodness only knows what will happen in the case of Covid vaccines.
Katherine Eban’s Bottle of Lies has put an additional complication on the radar. The original of a drug or vaccine may be prepared to a high standard in one setting but subsequent versions – both brand and generic – may be manufactured in India or China and contain contaminants that in the case of vaccines risk triggering auto-immune reactions.
It is possible therefore that vaccines this year will be pretty good, and relatively free of complications like auto-immune disorders but next year or the year after things may be different. Or disadvantaged may have a different profile of effects to privileged settings.
To keep track of this possibility means asking about the batch number of the shot you have been given. This allows you to trace it back to source. The team giving you the vaccines will not be used to anyone asking them for the batch number. They might not be pleased.
The ideal scenario moving forward is not a proper and transparent RCT. RCTs bring their own problems – See The Fault Lies in our Stars.
In the case of pregnancy, we should have registries with every pregnant woman recording what she was on before and during a pregnancy and any outcomes for her or her child with the record kept open for several years.
Working out what conditions might be linked to which treatments is a matter for everyone with a stake in the issue, women, doctors, regulators, companies and others to get involved in. Differing points of view are needed. We need people, perhaps driven by conflicts of interest, to defend their drug. At the end of the day the person who should decide whether to take something on the basis of these data and given the condition she has is the woman who is pregnant or thinking about getting pregnant.
The same applies to vaccines. Clearly there is a group rather than just individual issue to consider in this case. But it’s one thing to force a treatment on people where they and we know exactly what the risks are and the likelihood of them, its another to force a treatment on someone who has not been let know the risks or their likelihood.
RxISK will not be rushing out claims about vaccine x causing problem y. We may ask you some more questions and will ask you to update us over time.
The RxISK report gives you an opportunity to forward your report to the regulator in your country.
It will also include your contact details – an email. This means that it cannot be dismissed as anecdotal. Your name is removed from everything you or your doctor sends to FDA, MHRA, EMA and other regulators gets your name removed. This immediately makes it anecdotal. It cannot be properly followed up. As a result no regulator can ever say that drug x or vaccine x caused this or that.
Another advantage to your report is that the vaccine labels may give a one word description of a possible event – dizziness or nausea perhaps – but your report may give people a much better idea of just what the dizziness or nausea is like in this case.
My children are frontline healthcare workers one of whom has had a Covid vaccine and the other will take. My children had all vaccines. My extended family and all close acquaintances whose views I know are pro-vaccine. The only hesitation I’ve heard expressed is in terms of being happy not to be a priority for a Covid vaccine, so we have a chance to see what comes through after a lot of people have had it first.
I have painted myself into a corner in a BMJ contribution with Peter Doshi about data transparency, where I declared under the conflict of interest heading an unwillingness to take a vaccine where there was not access to the underlying data. This position is not anti-vaccine any more than it is anti-medication – I make a living from prescribing meds. Its anti-sequestration of data.
This year there is such a premium on taking a vaccine I will likely be prepared to compromise my principles.
Peter Doshi has a further contribution to this debate HERE.
Covid vaccines look like they might become an annual thing along with flu jabs. If so, we could do with some group, perhaps medical students from one country, to be a test group who takes annual flu and Covid jabs for 3-5 years, with another group of medical students taking nothing.