(See update at end of article).
She followed up this testimony by writing to the New England Journal of Medicine which until recently was viewed as one of the most prestigious medical journals in the world – Americans would say the most prestigious.
I was a participant in Astra-Zeneca’s Covid-19 vaccine trial . I suffered serious and severe adverse effects after the first dose of AZC1222, was disabled and remain so today.
I write to request inaccuracies in the trial publication be corrected, and to demand complete reporting of the trial publication and results.
The authors state that 180 AZD1222 recipients “withdrew” and “all serious adverse events will be recorded from the time of informed consent through day 730.” This is inaccurate. During hospitalization due to my adverse events, the trial investigators unblinded me, saw that I had received AZD1222 and recommended that I not receive the second dose. The trial smartphone app was subsequently disabled on my phone. I did not withdraw. I was withdrawn, and AstraZeneca chose to stop collecting my data after 60 days despite the fact that I remain with persistent symptoms one year later.
The trial publication lacks complete reporting of my adverse events, and readers are not informed that the trial smartphone app did not allow study participants to record adverse events in their own words.
The authors state that “No new vaccine-related safety signals were identified” but this may be an unreliable conclusion due to test clinics and the study sponsor neither recording nor reporting adverse events that did occur in study participants like myself.
Brianne Dressen, Clinical Trial Participant, Founder react19.org
Conflicts of interest: AstraZeneca has provided me $590 for my participation in the trial. They have not paid for any of my medical bills.
 A.R. Falsey, et al, https://www.nejm.org/doi/full/10.1056/NEJMoa2105290
There was an almost instant response from NEJM. Most unusually this came from the editor Eric Rubin. Her letter was too hot to handle and had been kicked upstairs to the boss. The boss’ response however was the standard one to letters or articles they don’t like – its the response that Joan-Ramon Laporte and I had to our modest proposal on how to help patients with Covid.
Dear Mrs. Dressen:
I am sorry that we will not be able to publish your recent letter to the editor. The space available for correspondence is very limited, and we must use our judgment to present a representative selection of the material received. Many worthwhile communications must be declined for lack of space.
Eric J. Rubin, MD, PhD
New England Journal of Medicine
Dear Dr. Rubin,
I am sorry to hear that you will not publish my letter. Apart from the letter itself, the far more important issue is the problems I wrote about. Will the NEJM be issuing any corrections to the Falsey et al. trial publication (https://www.nejm.org/doi/full/10.1056/NEJMoa2105290)? My letter documented how the article omitted key safety data in my case (I am aware of at least one other trial participant who suffered a similar reaction and is also missing from the AZ report) I have documentation proving trial participation as well as diagnosis of vaccine injury from the National Institutes of Health. The other injured participant also reported to the NIH. Omission of adverse reactions is a violation of a key tenet of clinical trial reporting.
Dear Ms. Dressen,
We rarely publish case reports and we have no investigative powers. I suggest that you use standard reporting mechanisms (though, if the diagnosis was made at the NIH, they should report) and follow up with the FDA and/or CDC which can actually investigate.
Dear Dr. Rubin,
I think there has been a misunderstanding. I did not ask to publish a case report, nor have I called for an investigation. I am reporting errors in the NEJM trial publication that require correction, and my understanding is that the journal is the place to report errors in a publication. Will you be taking action?
Dear Ms. Dressen,
The best we could do is forward your letter to the manufacturer. Only they are in a position to see the primary data. But you can do that yourself and I would encourage you to do so. Only you can provide the information that they can use to investigate.
Dear Dr. Rubin,
It is troubling to see that only the manufacturer is in a position to see the primary data. I think I understand what you mean, but I am not sure I fully agree. As I mentioned in my original letter, AstraZeneca stopped recording data on me at day 60, so they do not have all the data on my severe and serious adverse events that persist to this day which is beyond one year. The publication claims “serious adverse events will be recorded from the time of informed consent through day 730” and I am evidence that this is not the case.
At any rate, thank you for your offer to forward my letter to the manufacturer. I would welcome that and look forward to hearing from you what they say. I have read the NEJM publication and am confident in what I have described to you as errors in the publication which require correction. I suggest starting with a query asking whether the participants they describe as “withdrawing” actually “withdrew”. As I explained, I did not withdraw, I was withdrawn and the trial app on my phone was disabled.
Dear Ms. Dressen,
I’m sorry, I wasn’t clear. Our correspondence with authors is all confidential so you would not get any reply. That’s why I’d suggest that you write to them directly. You can also write to the FDA, the only agency with the capability of independently investigating claims of trial misconduct. I’m afraid that our writing about a single patient, without our being able to provide documentation, in a trial with tens of thousands of participants would not have any effect.
Three weeks earlier, Eric Rubin had been a voting member at an FDA Vaccine and Related Biological Products Advisory meeting looking at the issue of approving vaccines for 5-12 year olds – Rubin .
He had voted in favour of doing so, saying:
‘We are never going to learn how safe this vaccine is unless we start giving it’
If Dr Rubin has his way we will never learn how safe this vaccine is, at least not from journals that make so much money from pharma and publish articles from Surgisphere instead.
Meanwhile, Pfizer (and Astra-Z and J&J) will be getting reports of myocarditis and pericarditis and thromboses and strokes, and Guillain Barre syndrome, transverse myelitis, myasthenic disorders, optic neuritis, peripheral neuropathies and other problems following their vaccine. Many of these came from doctors who made links to the vaccine.
The Conclusions of Pfizer’s Safety System in response to all of these – see attached document – has been:
This cumulative case review does not raise new safety issues. Surveillance will continue.
The key word here is New. These were all expected. Expected because the vaccine was known to, or was known to be likely to, cause them. So there would be reports of them but because only things that happen to a statistically significant extent after the vaccine can, in Newspeak, be viewed as being caused by the vaccine, even when we know the mechanisms by which the vaccine does cause them, then they aren’t being caused by the vaccine – so no need for FDA or NEJM to bother their pretty little heads about this.
So unless someone turned blue and grew feathers – did a Sesame Street Sam Eagle on it, there was nothing there for anyone to pay any heed to.
The response to someone injured on the vaccine – See Here– is exactly the same as Pfizer use with BMJ, NEJM, BBC, NBC etc in response to any documents and witness statements a whistleblower might bring their way:
These documents and testimony have not been substantiated.
By this, they mean they have not gone through a Randomized Legal Trial (RLT) (randomized because juries are a crapshoot) and come out the far side of a jury verdict, where Pfizer will be arguing that if it didn’t happen to a statistically significant extent in an RCT didn’t happen.
A jury in Cheyenne Wyoming listed to this argument 20 years ago, thought it was crap and sided with Tim Tobin against GSK.
But while an RLT is a crapshoot once it starts, companies can throw billions of dollars into ensuring they never have to go through a crapshoot like the Tobin trial.
In the meantime, a whistleblower, just like someone injured on a vaccine, is going to come up against a wall of disbelief, or an unwillingness on the part of people in healthcare to entertain anything they might say. They will pretty quickly feel a pariah, a leper, end up being shunned by family and friends, and may even begin to worry whether they are going mad.
There is an ironic counterpoint to this post on RxISK this week – where a 14 year old boy and woman in her thirties are able to establish for sure what is wrong with them by googling Doxycycline and finding posts on RxISK or articles to linked RxISK post that give them enough assurance to stop Doxycycline to see if their problems clear up – which they did. See Mental Hijack.
Almost coinciding with this post, Maryanne Demasi has published an incisive piece covering these issues that contains a stunning detail she appears to have been the first to pick up.
See Are Adverse Events in Covid-19 vaccine trials… you can guess the rest of the title.
There are many striking points in this piece but the one that bowled me over was this
In AstraZeneca’s Phase III trial of its vaccine, the one in which Brianne Dressen was a participant, the 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.”
Given that deaths on the vaccines happen within two weeks of a dose – first or second – and given there are thousands been reported to regulators with reasonable estimates of up to 150,000 in the US alone more than half of which happen in this two week period, this is a quite extraordinary state of affairs.
You can see I’ve struggled not to repeat myself and used incisive, striking, stunning and extraordinary – to which we can add mind-boggling.
Johanna Ryan commenting on Maryanne’s post says:
This maps very neatly onto that “all-virtual” study of fluvoxamine for Covid-19. 100% of the side effects published were infection-related ones (fever, headache, cough), while side effects routinely found in other fluvoxamine trials were entirely absent. Including extremely common ones like dry mouth and excess sweating, which are also not-very-scary and not-very-psychological.
What is really being said here is there is no hint of suicidality or sexual dysfunction either – they aren’t in the pre-populated lists