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Discussion Starter · #1 ·
This is a scientific response addressing the critique of the EMA which has been echoed by a number of stakeholders, including the DHMA who surprisingly seem to have partially abandoned their conclusions from July 2015. But – it is also a personal responsum. I have been in this highly explosive field in four years now. I want to voice my ever increasing feeling of our considerable inabillity to be nuanced and balanced when discussing vaccines – both their efficacy and side effects. We are in desperate need of a shift in paradigm, a groundbreaking one, or the future of public confidence in vaccines will be lost.
This doctor is pro-vaccine. Weirdly, she thinks addressing and studying problems will help maintain the vaccine program. Where did she get such a silly idea?

https://t.co/6BKBhvVC5t
 

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Discussion Starter · #2 ·
Fascinating.

The EMA report accuses Dr. Brinth of selecting patients to fit a hypothesis. This isn't what happened. But the fascinating thing is that Dr. Wakefield was hit with the exact same accusation.

Dr. Brinth is really having a hard time understanding why her work, which is quite clear and clearly stated is being deliberately misinterpreted. I guess she is new to the vaccine wars.

EMA writes:
“Overall, the case series reported by Brinth and colleagues (2015) is considered to represent a highly selected sample of patients, apparently chosen to fit a pre-specified hypothesis of vaccine-induced injury.”(Page 24)
This is the most serious allegation I have ever been presented with. I can only understand this statement and their use of the word “apparently” as if they actually reveal that they just made an assumption. They made a guess. Contrary to this assumption made by the EMA, we did not select patients to fit a pre-specified hypothesis of vaccine-induced injury. We did not select patients based on symptoms in order to make sure that they would fit into a preexisting hypothesis. EMA suggests that we did. We did not.
from page 17

There really are patterns of behavior sometimes...
 

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Discussion Starter · #3 ·
Continuing to read. This is from page 24.
As I understand it, the observed versus expected analyses is a measure of the "observed" rate of the event versus the "expected" background rate. I believe that the "observed" rate is calculated with both an uncertain numerator and an uncertain denominator: the numerator being the total number of AER (which we believe may be a very large underestimation?) and the denominator is the total number of doses of the vaccine sold or distributed (which we know is a very large overestimation – I believe that health clinics buy in bulk and leave on the shelf and use until the expiration date comes). Therefore, of course, if you underestimate the numerator and you overestimate the denominator, you get a smaller-than-true "observed" rate. As I read it, the "expected" rate is taken primarily from literature sources? Given the overwhelming problem with the use of different diagnostic terms – or no diagnosis at all in this group of patients – how does this make any sense?
Note: It doesn't make any sense except to vaccine pushers, whose purpose has nothing to do with health or wellness. It is all about selling the maximum number of vaccine doses. Reports of illness following vaccination interfere with this purpose. Doctors who get in the way find their reputations trashed. This process is well underway for Dr. Brinth.

The goal of the vaccine pushers is to ignore, shove under the carpet, discount, explain away or simply deny anything that could possibly be counted as a vaccine reaction. Dr. Brinth and her colleagues did several things wrong.

1) They listened to the patients.
2) They collected information from the patients, wrote it up as 3 case series, and published them.
3) They didn't do any analysis that would help to dismiss or explain away the problems.

Now Dr. Brinth is compounding her sins by pointing out that the vaccine defenders aren't actually doing good science. What they are doing is lying and distorting what she actually did and wrote. I think Dr. Brinth is rather puzzled as to WHY the lies and distortions.

She'll live and learn.
 

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Discussion Starter · #4 ·
The good doctor is getting steadily more puzzled.
So – altogether I find the criticism put forth with regard to my work and my scientific approach unjust. I find that the evaluation of my work presented by EMA is based on many assumptions. Most of these assumptions are to my best knowledge wrong. I find this approach strange and unscientific. I find it very worrying that EMA apparently base their judgement of my work – and thereby indirectly also part of their judgement of the safety of the HPV-vaccines - on guesses. This is too important for guess-work. We need to know and we need to reach consensus on what we know, what we need to know and what should be done.I do not think EMA’s methods, approach and rhetoric encourages this.
If only she could have been enlightened by someone like Skeptical Rapture before this whole thing began. She would have known that any patient who brought up any vaccine as possibly connected to any chronic ill health was just a troublemaker and should be ignored.
 

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Discussion Starter · #5 ·
However, the hypothesis which was generated by the UMC based upon this data “that the same clinical syndrome may be occurring following HPV vaccination but is being diagnosed/coded differently across countries” appears to have been acknowledged by the EMA “…it cannot be excluded that this is the case”. I find it strange that the EMA is not interested in further investigating this possibility given the gravity of the situation at hand.
The grave situation that the EMA is trying to sort out is the possible suspension of the recommendation for the vaccine as happened in Japan. They don't consider hundreds of very ill girls a grave situation at all.

This quote follows a section where Brinth compares what the EMA report says as compared to what the Uppsala Monitoring Center (UMC) report says. Basically the EMA took out a bunch of significant information in order to get the results they wanted (a clean bill of health for the vaccine) and Brinth is, again, quite puzzled as to why the EMA is playing such silly games and risking girl's health.
 

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Discussion Starter · #6 ·
How to present a united front? Just gag the individuals.

Creating a sort of false consensus based on the participants being bound to secrecy will inevitably lead to the impression that “all these many experts agreed on the conclusion set forth by EMA”. This makes it difficult for solitary scientists and medical professionals as myself to disagree. Who am I to disagree with all these many experts who voice this conclusion unanimously? I am not questioning whether the people selected for the SAG-meeting were qualified. I am not saying that they did not do a good job. But I find it hard to believe that they all agreed on all aspects of this highly complicated and controversial matter. I believe that all the different viewpoints presented at a meeting like this would enable us to grasp a little more of the nuances of this issue.
Nuances? Who wants nuances? Defending the vaccine is what matters!
 

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Discussion Starter · #7 ·
Both CRPS and POTS are difficult syndrome diagnosis with huge overlap to other syndrome diagnosis. For both diagnoses goes that they often will only be diagnosed at specialized clinics. They are applied very differently by different countries. It is difficult to count things that may not necessarily have a label or a labeled differently around the world.
And yet it is possible to claim that there is a known "background rate" of these syndromes? And on that basis claim that there is no increase in incidence and therefore the vaccine is not connected?

Very impressive!
 

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Discussion Starter · #8 ·
Following several pages in which she discusses the problems of diagnosis and the possibility that the underlying cause is linked to auto-immunity, Dr. Brinth begins to sum up what she sees as the core problem.
I have been contacted by quite a few fellow- doctors, researchers from Denmark as well as from other countries. Many of them tell me that they have the same suspicion, they see the same pattern – but most of them tell me that they are afraid to speak up. I find that we have established a culture where it is not acceptable to have a critical approach towards vaccines. We may all state that ”of course all medicine, vaccines included, have the potential of eliciting side effects….” But when it gets tangible and concrete – when an actual doctor suspects that an actual patient has contracted an actual disease as a side effect to an actual vaccine – then many of us find it difficult to handle. We want him or her to shut up. We want the suspicion to go away. We want vaccines to be 100% safe.
Sure sounds familiar.
 

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Discussion Starter · #9 ·
It would be good if the sort of thoughtful and thorough work that Dr. Brinth suggests were to be undertaken.

I have small hopes.

What is more likely is the following:

Dr. Brinth will be viciously attacked in an attempt to shut her up and to intimidate any other doctors who might have be considering speaking out.

The parents and the girls and the boys will continue to make all the noise they can about the problems they are experiencing.

The authorities will continue to deny any connections.

Uptake of the vaccines will continue to decline or at best hold level. This will be blamed on the "anti-vaxers" and on "religious fanatics".

In the US there will be more attempts to mandate these vaccines as was done in Rhode Island, only without any option to refuse.

There will continue to be attempts to bury, deny and hide any problems.
 
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Discussion Starter · #10 ·
I'm bumping this up since we have been discussing Dr. Brinth and her work in another thread.

She'll be getting slapped with an "anti-vaccine" label any day now.

Some people don't want to read her entire 60 page analysis. This thread has a number of excerpts to make it easy for folks with limited time available.
 

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Discussion Starter · #11 ·
https://t.co/GGCGQtZhce

New document released by the Nordic Cochrane Institute.

The prominent symptoms, which are suspected of being caused by the vaccine, are similar to those seen in so-called functional disorders such as chronic fatigue syndrome (CFS) and include postural orthostatic tachycardia syndrome (POTS) and chronic regional pain syndrome (CRPS). The hypothetical mechanism is an autoimmune reaction triggered by either the active component of the vaccine or the adjuvant in the vaccine. These syndromes are difficult to diagnose; their causes are poorly understood; and they are likely to be underreported. This complicates studies of a causal link.
 

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Discussion Starter · #12 ·
This document is 19 pages long. I challenge any HPV vaccine supporter who was pleased with the EMA report to read it and respond. It is scathing.
 

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Discussion Starter · #15 ·
I've finished reading the entire document. There are huge problems with the EMA report and, as a direct result, a large loss of trust in HPV vaccines.

One point mentioned is that when narcolepsy was first described as a side-effect of Pandemrix, the first thing done by authorities was to mock and attack the doctors who brought forward the info. It turned out that they were right, but even if they had been wrong, doctors who raise concerns about possible safety problems with drugs or vaccines should be supported, not attacked. [my summary of content]

Unless, of course, the main purpose of agencies like the EMA is to protect drug companies from loss of sales income.
 

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Discussion Starter · #16 ·
I'm going to work my way through the 19 page document from the Nordic Cochrane Centre page by page summarizing the main points.

I can't do a lot of quoting without violating copyright so I'm going to summarize instead.

Page 1

Starts by quoting the Charter of Fundamental Rights of the European Union on "openness" and questions whether the EMA is complying.

They question the quality of the science.

They criticize the attacks on Louise Brinth, the main whistleblower bringing forward concerns about the HPV vaccine safety.

They also ask if the Danish Health and Medicines Authorities and the Uppsala Monitoring Centre were treated fairly after they raised concerns.

They ask whether having the manufacturers assess the safety of their own products results in a legitimate process

They critique what they call "extreme secrecy" in the EMA process. [Side-note, this extreme secrecy seems to be failing, someone leaked the much longer, 256 page, internal report which doesn't agree in all particulars with the 40 page public report].

Thus ends page 1.
 

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Discussion Starter · #17 ·
Continuing with page 2 of the Cochrane critique of the EMA report

Freedom of info requests arrived with "redactions" and the first question is whether these were legitimate.

Asks about possible conflicts of interest in two people involved in producing the report

Asks if the EMA HAS to use experts with conflicts of interest, i.e. links to manufacturers?

Suggests that conflict of interest statements for absolutely everyone involved be made public.

The next section gives an overview of the sequence of events, starting with various organizations in Denmark raising concerns about the safety of Gardasil.

They point out (this is the part I quoted a few posts above) that the symptoms are tricky to diagnose and there is no easy way to sort out what is going on.

They point out that the official report makes it look as though it is perfectly clear: no connection between vaccine any health concerns. However, the internal report isn't anywhere near as clear, and a few months before the EMA had been taking the situation much more seriously.

end of page 2
 

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Discussion Starter · #18 · (Edited)
Page 3 through page 8 reviews Dr. Brinth's response to the EMA report which has already been discussed in this thread. Cochrane states multiple times that they agree with Dr. Brinth. They also point out that at the time she wrote her response, she did not have access to the 256 page internal report which was eventually leaked.

Wanted to add that Cochrane obviously agrees with Dr. Brinth's response.
 
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Discussion Starter · #19 ·
The foot of page 8 begins a new section.

Cochrane points out that redactions in documents obtained via Freedom of Info requests make no sense, based on the leaked 256 page internal report. In other words, they can easily compare what is being redacted with the complete info, and in many cases there is no reason to redact something, or it is still obvious from the context.

On page 9 they give several specific examples of redactions. Some seem to be attempts to make it difficult to impossible for readers to follow information to a source, or to muddy the waters to make it harder to sort out what is really going on in various countries. And some are just plain silly.

At the foot of page 9 they start a new section discussing uncertainties in the science which are visible in the leaked internal report and hidden in the public report.

Pages 10, 11 and part of 12 list expressions of scientific uncertainty from the internal report which ceased to exist for the public report. There are 6 such expressions listed, none of them minor.
 
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Discussion Starter · #20 ·
On page 12 there is a discussion entitled "Are the Vaccines Safe?"

They go through the placebo problem of a small group that got a real placebo, versus the much larger group that was injected with a significant dose of aluminum. They accuse the company and the EMA of deception and mention Vioxx and the way that problems with that drug were hidden from the public.

They aren't enthusiastic about the idea that the vaccine is so important that data cover-up and even lies are necessary. The term they direct at the EMA is "scientific misconduct."

The next section, still starting on page 12, discusses conflicts of interest. It begins by pointing out that the EMA depended on the manufacturers of the vaccines to provide the data. This is a conflict of interest, as the data was discussed but not critically analyzed. Ouch.

I won't go through all of the various conflicts of interest. If someone is interested, start on page 12 and continue on through part of page 15.

Pages 15-17 offer final remarks. These are scathing. I'd sum it up by saying that the authors feel that the EMA desire to defend the vaccine was so strong that they abandoned good science and even basic honesty.

Is this an anti-vaccine organization? Why else would they criticize the EMA for defending these wonderful vaccines?
 
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