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.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.
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."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.
Lol.Well, that's really the key thing right there. It's really just another example of confirmation bias.
Because the entire complaint hinges on a group of anecdotes, not on actual scientific evidence and is incredibly sloppy.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?
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.
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:
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.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.
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.
Going almost entirely with the data from the drug companies seems pretty questionable. They want to keep moving product, ya know?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.
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: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.
This is exactly what I keep pointing out. Studies done by the manufacturer can be managed or structured so as NOT to spot problems.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.