z92x38y12
protocol: "Aluminium adjuvants used in vaccines versus placebo or no intervention"
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD...
Cochrane Systematic Review - Intervention - Protocol Version published: 24 September 2017
"More than 10 years has passed since the systematic review by Jefferson and colleagues, new adjuvants are being introduced continuously, and FDA and WHO do not require genotoxicity or cardiotoxicity studies of new aluminium adjuvants (WHO 2014b; FDA 2015). Lately, symptoms following HPV vaccination have been suspected of being caused by the addition of aluminium adjuvant (Tomljenovic 2011; Lee 2012; Poddighe 2014; Brinth 2015b; Gruber 2015; Martinez‐Lavin 2015). A recent animal study by Inbar and colleagues managed to spark further controversy by demonstrating behavioral abnormalities in mice administered the aluminium‐containing HPV vaccine Gardasil (Inbar 2016a). Compared to previous animal studies on HPV vaccines, the authors included two control groups: one where mice were administered aluminium adjuvant alone and another with placebo without adjuvant (Inbar 2016a). Inbar and colleagues concluded that Gardasil via both its aluminium adjuvant and HPV antigens can trigger neuro‐inflammation and autoimmune reactions, leading to behavioural changes in mice (Inbar 2016a). Upon submission to a peer‐reviewed journal, the paper was accepted with revisions, and published. However, it was soon withdrawn by the editor (Inbar 2016), only to be published in a competing journal shortly thereafter (Inbar 2016a). The initial withdrawal was allegedly due to "unsound scientific results"; an assertion which was not supported by the final publisher.
The theory that aluminium adjuvant is responsible for symptoms following HPV vaccination is impossible to refute or prove based on the current data. Aluminium adjuvant has been administered to both experimental and control group in the vast majority of randomised clinical trials on HPV vaccines, thus masking its potentially harmful effects (Exley 2011). Clinical trials designed to administer vaccine adjuvants to the experimental group as well as the placebo group do, de facto, not compare an intervention against a true placebo, and therefore, do not adequately assess safety (Exley 2011). Indeed, aluminium adjuvants, new or old, should be evaluated for benefits and harms on their own merits.
Aluminium is the most frequently used adjuvant, introduced in vaccination programmes worldwide (Tritto 2009). While the consequences of adding aluminium to vaccines have been discussed broadly, no systematic review has been conducted to assess the effects of aluminium adjuvants across vaccines. The effects of aluminium adjuvants remain to be properly assessed using Cochrane methodology to determine whether they are beneficial, or causally linked to the numerous adverse events reported following immunisation."
- Industry trial funding and other conflicts of interest
- No real placebo test - and it is normal according to the expert.
- etc.
"No included trial in the Cochrane review used a placebo comparator All 26 trials included in the Cochrane review used active comparators: adjuvants (aluminium hydroxide (Al[OH]3) or amorphous aluminium hydroxyphosphate sulfate [AAHS]) or hepatitis vaccines."
"The Cochrane authors mistakenly used the term placebo to describe the active comparators. They acknowledged that ‘The comparison of the risks of adverse events was compromised by the use of different products (adjuvants and hepatitis vaccines) administered to participants in the control group’. Nevertheless, this statement can easily be overlooked, as it comes after 7500 words about other issues in the discussion and under the heading ‘Potential biases in the review process’. Active comparators was not a bias in the review process but a bias in the design of the HPV vaccine trials."
source:
"The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias"
BMJ Evidence-Based Medicine October 2018 | volume 23 | number 5 |
context:
(14 January 2019 )
As one reviewer put it: “The article transparently lays out not just that the EPA and IARC came to different conclusions about the genotoxicity of glyphosate-based herbicides, but how this result occurred and its impact on the overall conclusions about its carcinogenicity. The analyses contained in this article and accompanying text enhances the understanding of the state of the science of the potential carcinogenicity of glyphosate-based herbicides and gaps in understanding that future studies may help to resolve. As such, it is an important contribution to the literature”
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Editorial:
"Some food for thought: a short comment on Charles Benbrook´s paper “How did the US EPA and IARC reach diametrically opposed conclusions on the genotoxicity of glyphosate-based herbicides?” and its implications"
https://enveurope.springeropen.com/articles/10.1186/s12302-0...
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more ... more ... ( & Open )
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(14 January 2019)
"How did the US EPA and IARC reach diametrically opposed conclusions on the genotoxicity of glyphosate-based herbicides?"
https://enveurope.springeropen.com/articles/10.1186/s12302-0...
"""
" Three of the study authors were tapped by the EPA as board members for a 2016 scientific advisory panel on glyphosate. The new paper was published by the journal Mutation Research /Reviews in Mutation Research, whose editor in chief is EPA scientist David DeMarini.
The study’s authors say their meta-analysis is distinctive from previous assessments. “This paper makes a stronger case than previous meta-analyses that there is evidence of an increased risk of NHL due to glyphosate exposure,” said co-author Lianne Sheppard, a professor in the Environmental and Occupational Health Sciences department at the University of Washington. “From a population health point of view there are some real concerns.”
Sheppard was one of the scientific advisers to the EPA on glyphosate and was among a group of those advisers who told the EPA that it failed to follow proper scientific protocols in determining that glyphosate was not likely to cause cancer. “It was wrong,” Sheppard said of the EPA glyphosate assessment. “It was pretty obvious they didn’t follow their own rules. “Is there evidence that it is carcinogenic? The answer is yes.”
An EPA spokesperson said: “We are reviewing the study.”
""" https://www.theguardian.com/business/2019/feb/14/weed-killin...
(Irish university scientists) willingness to buy GM baby food? (41.4% would buy; 45% would not; 13.6% not sure)
"4. Willingness of scientists to buy GM food : Respondents were asked how willing they would be to buy certain types of genetically engineered food if they were at the same price as similar non-GM products. The axiom that those buying food would do so to consume it was drawn. These results are shown in Table II. Of the respondents 60.4 per cent would buy genetically modified food items if they were the same price as non-GM food with the notable exception of baby food (41.4 percent would buy; 45percent would not; 13.6 percent not sure). T-tests carried out showed that when the means were compared, the drop in willingness to buy GM baby food was statistically significant (p < 0.01). This drop is an interesting insight into risk analysis of the scientist."
"Genetically modified food issues: Attitudes of Irish university scientists - Shane H. Morris Catherine C. Adley" (2000)