That dossier contained 19 studies EFSA’s health claim panel found pertinent but ultimately non-supporting of the claim, a verdict professor Pierre Bourlioux said should be revisited as significant trial data had been dismissed or ignored.
Professor Bourlioux, who was a Pharmacist and Professor of Microbiology at the Faculty of Pharmacy at the University Paris-Sud between 1973 and 2001, and is a member of Danone’s International Scientific Advisory Board on Health Benefits of Probiotics, said supportive in vitro, pilot study and open trial evidence needed reconsideration.
In a letter to the EC written during the 30-day response period to the EFSA rejection of its article 14 disease reduction claim in December, Professor Bourlioux reiterated a point made in Danone’s own response to the opinion that blinding issues in the central trial of the dossier highlighted by EFSA, were not seen to be problematic by the British Medical Journal.
In that instance EFSA’s Panel on Dietietic Products, Nutrition and Allergies (NDA) found that while the trial patients were genuinely blinded to Actimel and another yoghurt drink in the hospital phase of the trial as they were given the drinks in neutral containers, they were later given two different-shaped bottles, which spoiled the blinding and discounted the statistically significant trial results.
“No additional information on that point was requested by the panel through the evaluation process,” he wrote. “Where is the suspicion of bias coming from and why wasn’t there any previous discussion of that point?”
Danone had proposed the claim wording: “Fermented milk containing the probiotic Lactobacillus casei DN-114001 and yogurt symbiosis decreases presence of Clostridium difficile toxins in the gut (of susceptible ageing people). Presence of Clostridium difficile toxins is associated with the incidence of acute diarrhoea.”
The NDA opinion can be found here. Coverage of the company’s response can be found here.
With or against?
But speaking to NutraIngredients at a European Nutrition and Lifestyle conference in Brussels today, a spokesperson for the Confederation of Food and Drink Industries in Europe (CIAA) warned that companies should consider the broader picture when responding to EFSA’s work.
“Attacking EFSA is not the most productive approach,” he said. “Of course companies have the right to make comments but it is important to consider the way the comments are received. We need EFSA and we need health claims so it is better to be with them than against them.”
He said discussions had revealed EFSA was interested in improving its procedures including the possibility of pre-submission meetings to assist in trial design and dossier construction. But such changes may take 2-3 years to eventuate, he said.