Примери за използване на Brinth на Английски и техните преводи на Български
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We agree with Brinth.
Brinth: Nausea, headache, abdominal pain, fatigue etc.
We agree with Brinth.
Brinth:“As far as I can see, the minutes of the[EMA] meetings are not released.
It is noteworthy that the co-rapporteurs agree with Brinth see“7.
Brinth” above and that this support for her arguments did not make it to the EMA's official report(2).
The vast majority of POTS reports came from a centre in Denmark(Brinth et al, 2015)1.
Brinth did not have access to the confidential internal report(4) when she wrote the document, only to the official one(2).
It seems to us that it is the EMA that uses andaccepts substandard methods, not Brinth(see more examples below).
Brinth:“Were there any opportunities for PRAC-members, SAG-members or other assessors to ask additional questions or for clarifications?
There are many problems with the EMA's official report,and Louise Brinth has drawn attention to them in a 63-page document from 17 December 2015(5).
Brinth: According to the UMC report, chronic fatigue syndrome has“been increasing since 2012 with a marked increase between 2012 and 2013”(5, p27).
This is very serious,as the EMA used the companies' assessments to overrule the research done by Brinth, which is of a much higher standard.
Brinth furthermore writes that her observations and hypotheses were supported by the independent review of the global data made by the Uppsala Monitoring Centre(5, p26).
The co-rapporteurs are highly critical of the EMA's draft report and yet again,they agree with Brinth, but this strong support for her arguments did not make it to the EMA's official report(2).
We agree with Brinth that the EMA misrepresented the UMC review in its own report, thereby creating the impression that Brinth should have published substandard research.
Whether the EMA has treated fairly- in a manner that guarantees that the administrationenjoys legitimacy- a Danish whistleblower, PhD Louise Brinth, when she raised concerns about possible serious harms of the HPV vaccines?
Brinth states in her report that she and her co-workers included all consecutively referred patients, with the exception of the ones excluded because they met the exclusion criteria(5, p17).
The EMA asserts that:“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”(2, p24).
Brinth: The UMC noted that“a significantly greater proportion of the reports from Denmark were considered“good reports”; were classified as“serious”; and were received from either a physician, consumer or a lawyer(5, p28).
Brinth: The EMA asked the MAHs to provide an analysis of the observed number of post-marketing cases of CRPS and POTS in association with their HPV vaccine in comparison to those expected in the target population.
Brinth says it would have been relevant to have these search strategies clearly defined and given because, to the best of her knowledge, there are no common search strategies which have been previously defined for either POTS or CRPS(5, p35-36).
Brinth writes that the EMA's official report notes on page 12 that PRAC requested the MAHs to search not only“for reports specifically containing the terms POTS and CRPS” but also to use.
Brinth:“Reading EMA's report it seems to me that the review of the safety data which includes available data from the clinical trials and post-marketing surveillance and the literature review was all collected by the marketing authorization holders(MAHs)[GlaxoSmithKline Biologicals, Merck Sharp& Dohme Limited, and Sanofi Pasteur MSD]?
Brinth: The EMA's question 2 to the companies”does not make any sense to me: If both the“vaccine group” and the“control group” received aluminium adjuvanted“placebo” or another aluminium adjuvanted vaccine as“placebo”- how does it make sense to ask the company to only discuss potential explanations including risk factors for the development if a difference is observed?