Leiber’s consultant, analyze&realize, in June submitted comments to the European Commission questioning EFSA’s treatment of primary and secondary outcome parameters in its submission for its Yestimun blend, but EFSA dismissed the comments.
Dr Juliane Kleiner, the unit head of EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) wrote that a post-hoc analysis conducted by analyze&realize that removed summer months from a mainly winter-based study on the incidence of common colds did not remove potential diagnostic error from the study.
Analyze&realize argued that increased pollen counts and therefore incidences of allergic rhinitis (a minor aspect of the study) in the summer months warped the results so that statistical significance was not achieved, and that those summer months should be discounted when interpreting the study.
The German consultancy also criticised EFSA for focusing on this part of the post-hoc analysis when its central theme was that common colds were more prevalent in winter.
But Dr Kleiner, in consultation with her panel, along with the chair of the NDA panel, Dr Albert Flynn and Professor Sean Strain, chair of the Working Group on Claims, said occurrence of allergic rhinitis was not restricted to the summer months.
“…EFSA does not accept that avoidance of possible misdiagnosis error is an appropriate justification for the conducted post-hoc analysis.”
Analyze&realize consultant Christiane Alexander, PhD, told NutraIngredients a new study was underway that began in October and would end in March, 2010 that would remove any summer-winter seasonal debate from the equation.
Causality not demonstrated
Dr Kleiner also wrote that a reduction in secondary outcomes such as sore throats, hoarseness or coughing could not be directly attributed to effects on the immune system.
“Pathological consequences of a viral infection are immunologically mediated only in part and effects on the symptoms of infections per se cannot be attributed to effects on the immune system.”
In dismissing these objections Dr Kleiner affirmed the initial opinion that causality had not been demonstrated. That opinion can be found here .
Alexander told said her firm and Leiber were frustrated by the EFSA response, which she said “lacked detail” and did not address all the points raised in its June submission.
That submission can be found here.
She said no guidance had been given about how to better design and conduct trials with immunity end points and questioned recent EFSA-issued gut health/immunity guidance which seemed to be validating certain molecular biomarkers that had been discounted in the Yestimun opinion.
But Ian Rowland, professor of human nutrition at the University of Reading’s Department of Food and Nutritional Sciences said the dossier appeared to fall short in regard to, “immune markers such as T cell activation and cytokine profiles”.
This meant too much emphasis was placed on the secondary measures such as cold incidence, he said.