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Discussion Starter · #3 · (Edited)
I saw that.

I must say, getting a Julie/Julie wrong (if they did) does not negate any of their concerns.
 

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Considering a fairly substantial part of their complaint was about her alleged undeclared and dishonest conflicts of interest and conflicts of interest in general, yes it is a big deal that they got the completely wrong person and does negate a lot of their concerns since the "real" Julie does not have any conflicts of interest. In fact, 3 out of their 10 listed complaints at the beginning of the letter are about conflicts of interest.

The post addressed many of their other concerns as well, but I cannot copy and paste the whole thing. I provided a link for those who are interested.
 

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Considering a fairly substantial part of their complaint was about her alleged undeclared and dishonest conflicts of interest and conflicts of interest in general, yes it is a big deal that they got the completely wrong person and does negate a lot of their concerns since the "real" Julie does not have any conflicts of interest. In fact, 3 out of their 10 listed complaints at the beginning of the letter are about conflicts of interest.

The post addressed many of their other concerns as well, but I cannot copy and paste the whole thing. I provided a link for those who are interested.
Besides which, it's such an indication of rush to judgment. It's easy to find "evidence" of something you already think is there, because you lose critical thinking.
 

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Besides which, it's such an indication of rush to judgment. It's easy to find "evidence" of something you already think is there, because you lose critical thinking.
Right. Plus, the basis of their entire complaint is a group of case reports (aka fancy anecdotes) that have "no controls, no denominators, and no baselines."
 

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And yes, they are totally different people.

Wales Julie is from Wales, has a degree in psychology from Cardiff University, is one of the world's leading researchers on Alzheimer's, and still works there. This is the wikipedia link that the complaint referenced about her.

https://en.wikipedia.org/wiki/Julie_Williams_(scientist)#cite_note-Welsh_Government-3

Compare that to EMA Julie http://www.ema.europa.eu/docs/en_GB/document_library/contacts/jwilliams_CV.pdf. Totally different degrees, college, location and study focus.

Lol. Epic fail.
 

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Discussion Starter · #9 ·
I find it very sad that a serious complaint is being dismissed over nitpicky-ness. Sad and telling. Why on earth are you (speaking generally) so quick to defend the status quo without consideration of the complaint?

Can you see why some of us have trust issues when even a complaint made by a prestigious body is blown off?
 
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Discussion Starter · #10 ·
Well, that's really the key thing right there. It's really just another example of confirmation bias.
Lol.

I see bloggers rush to dismiss the complaint and the pro-vaxxers on this thread latching onto what skeptic bloggers said, instead of considering the actual complaint.

I do indeed call confirmation bias.
 

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I find it very sad that a serious complaint is being dismissed over nitpicky-ness. Sad and telling. Why on earth are you (speaking generally) so quick to defend the status quo without consideration of the complaint?

Can you see why some of us have trust issues when even a complaint made by a prestigious body is blown off?
Because the entire complaint hinges on a group of anecdotes, not on actual scientific evidence and is incredibly sloppy.

She is also not *just* a "skeptic blogger". Her name is Helen Petousis Harris:

Her background is predominantly biological sciences, and she did her PhD in Vaccinology, specifically around vaccine reactions. She has worked at the Immunisation Advisory Centre at the University of Auckland since 1998 where she has developed a passion for all things vaccine. Currently Helen has an appointment as a Senior Lecturer in the Department of General Practice and Primary Health Care and her teaching is largely around vaccination.
 

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Discussion Starter · #12 ·
There is a lot in the report and definitely gives me more pause than before with regards to HPV.

I will quote this one part, as it mirrors how this discussion is going:

"The bottom line for the EMA seems to have been that the vaccine should be protected from criticism at all costs because it is believed to save lives by protecting against development of cervical cancer. One sign of this is that the text in the official report is nearly identical to the assessments of the rapporteur and the companies. However, this paternalistic attitude comes at a great cost. The EMA accepted uncritically substandard research performed by the MAHs and produced a superficial, substandard official report (2) that was clearly flawed and unrepresentative, considering the serious concerns raised in internal discussions, which were sealed by life-long confidentiality agreements. Unprofessional and defamatory criticism, such as the one the EMA raised against the Danish researchers, is not unknown to scientists but it is a serious threat to scientific progress and public health. Those who raise concerns should be complemented for their courage, even if their suspicions are later shown to be wrong."
 

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This part is particularly relevant:

The complaint begins by outlining the case of Dr Louise Brinth’s article that describes some cases of chronic fatigue-related syndromes along with a hypothesis. This article presents a series of cases and the only case provided in detail had an alternative explanation of viral illness at the time of vaccination. Only a very high level overview is provided in the paper for the other cases and no comparison with unvaccinated cases is included, despite the author suggesting that they had a very long experience of diagnosing these cases which would presumably pre-date the start of the vaccination programme. Below is the EMA conclusion on the Brinth paper, which they reviewed:

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. The methods used to ascertain the trigger and time to onset of specified symptoms of autonomic dysfunction may inherently bias patient recall. Whilst Brinth and colleagues (2015) acknowledge that their cases series cannot prove a causal association with HPV vaccine, they do not acknowledge or discuss the possibility that their case series simply reflects the expected characteristics and prevalence of POTS and autonomic dysfunction amongst a population cohort with 90% vaccine uptake. The authors speculate that high intensity physical exercise may be a risk factor for development of HPV vaccine-induced illness, but do not reflect upon the available medical literature suggesting that this is a commonly-reported characteristic in POTS patients, regardless of putative trigger. Finally, Brinth and colleagues (2015) now propose that their case series should be considered as having CFS induced by HPV vaccine and that this requires further, robust study, but dismiss an existing study that has already tested this hypothesis and found no association.
I think this whole thing boils down to one author disgruntled that their case series data (and that of others) has not being found to imply causality.

If the Cochrane Collaboration are all about evidence as a whole then why would they argue the value of a series of case reports when no other evidence supports them? They don’t tend to include case reports. A whingey letter in no way constitutes scientific evidence.
 

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Yeah, Dr. Brinth was very angry about her case series being described as selected. She responded to the EMA in detail explaining exactly how and why the cases went in.

What I LOVE about this whole process is the sequence.

Dr. sees problems in real live patients that follow actual vaccine administration. She reports this and writes up a case series in the usual way, which passes peer review and is published.

Then she gets attacked. Her work is misrepresented. I'm sure that within a few more weeks she'll be called "anti-vaccine."

Ladies, this isn't a scientific process. This is vaccine defense 101 and it is totally standard.
 
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Just wanted to add that none of the pro-vaxers on this forum were willing to actually read what Dr. Brinth wrote and it looks like none of them have actually read what Nordic Cochrane wrote. They are reading a skeptic's analysis of the documents...
 
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Discussion Starter · #16 ·
I have skimmed it twice.

A lot of the issues seem to come down to secrecy and allowing pharmaceutical companies to be their own judge and jury.
 
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Discussion Starter · #17 ·
An intersting point on vaccine safety:

"According to the firms they are safe. Initially, the vaccine was compared with a placebo group being vaccinated with physiological serum, whereby the number of adverse reactions was much higher and much more serious than in the control group. After comparing 320 patients in the saline placebo group a quick move was made to an aluminium-containing placebo, in order to be able to only evaluate the effects of the active substance. However, this distorted the comparison, because no one voluntarily wants to be vaccinated with toxic aluminium, as this is not really necessary, when inoculation with a harmless saline solution can be done. The differences between Gardasil and the saline placebo group were, however, already noticeable15. Here we can refer to the Vioxx scandal, where the adverse reactions in fact were known, but concealed by the firm. Here also the difference between the vaccine and the saline placebo is concealed in all publications, as the table below clearly shows. For serious adverse reactions one suddenly takes the saline and aluminium group together, perhaps to cover up the major differences between these two groups.

These two experts question seriously the prevailing assumption, apparently also at the EMA, that the vaccine is so important for public health that it is justified not to communicate to the public 1) that there are uncertainties related to vaccine safety, 2) that drug companies cannot be trusted; and 3) that it is wrong to lump together results obtained with a genuine placebo with those obtained with a potentially neurotoxic placebo. We agree with the two experts when they suggest that this lumping may represent a cover up and we also find that the EMA should have informed the public about this unacceptable lumping of a true placebo with an active placebo instead of keeping it secret. This is totally unacceptable and contrary to good scientific practice to such a degree that we consider it outright scientific misconduct committed by the EMA."

ouch.
 
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I have skimmed it twice.

A lot of the issues seem to come down to secrecy and allowing pharmaceutical companies to be their own judge and jury.
Going almost entirely with the data from the drug companies seems pretty questionable. They want to keep moving product, ya know?

The longer report that was kept secret made it clear that there were some serious issues that were swept away to present a unanimous front for the short version.

Both of those problems represent valid concerns, even if the authors made a terrible mistake by getting one scientist mixed up with another scientist.
 
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Medscape discussion of the Nordic Cochrane report. They discuss some of the actual issues rather than looking for reasons to dismiss all concerns and to attack any doctor who raises concerns. http://www.medscape.com/viewarticle/865686#vp_1

At the heart of the issue is whether the chronic symptoms that have been reported after HPV vaccination are causally related to the vaccine.
"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 Nordic group explains. "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," it adds.
I'm very concerned about the push to dismiss all case reports. HOW IN THE WORLD can a proper evaluation be made of the risk of an intervention if case reports are automatically dismissed without further research? Or with research that consists of this sort of arrangement:
The leaked internal document quotes one of the experts, who was unnamed, as saying: "In the search for cases coded as POTS in the database the manufacturers make a further selection by case definition criteria that appears too limiting.... 83 reports are identified as medically confirmed but out of these almost half (40 cases) are then dismissed for not meeting the case definition for POTS. It appears that they have been dismissed mainly due to lack of information in the reports. This does not appear to be in accordance with good practice, since spontaneous reports cannot be expected to describe all details for a diagnosis given to a patient."
Another issue is that the manufacturers were asked to search their databases "for reports specifically containing the terms POTS and CRPS" and were also asked to use "common search strategies...to identify possible cases of undiagnosed CRPS and POTS," but these strategies were not described.
"This is extraordinary, as the companies have a huge vested interest in not finding these possible harms in their databases," the Nordic group comments.
It illustrates the point with a case from the not-distant past. In 2014, the Danish Health and Medicines Authorities asked Sanofi Pasteur MSD to review its database for potential adverse effects of its HPV vaccine. The company searched it in such a way that very few of the known cases showed up ― only 3 of 26 Danish reports of POTS came up in the company's search.
This is exactly what I keep pointing out. Studies done by the manufacturer can be managed or structured so as NOT to spot problems.

Again, speaking as a librarian, I could easily structure a search of our library database so that certain material WOULDN'T turn up. Even though it was there. And there are people who are so trusting that they are sure that MERCK wouldn't do a sloppy search that missed some actual problems--when there are billions of dollars in income depending on missing those problems for as long as possible?

It is okay if the manufacturer does a selection of cases that makes the vaccines look safer--but Dr. Brinth who did NOT select her cases is attacked for selecting cases--and is having her character destroyed because her research and reports are undermining "trust" in the vaccine.

I'd trust Dr. Brinth over Merck any day. I'd also trust Dr. Brinth over any of the skeptic bloggers who are so passionately loved by some folks.

But, I should acknowledge that it is hopeless. The commitment to defending Gardasil goes very deep and no real concerns about the safety of this vaccine will ever be taken seriously.
 

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Bumping up this thread because people are still defending Gardasil and refusing to acknowledge that ANY of the problems following the vaccine might represent real reactions.
 
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