Valio demands EFSA reveal its “methodological and statistical requirements”

By Shane Starling

- Last updated on GMT

Related tags: Scientific method

"Will EFSA release guidance documents in the near future?" asks Valio.
"Will EFSA release guidance documents in the near future?" asks Valio.
Finnish dairy group and ingredients supplier Valio has challenged the European Food Safety Authority’s rejection of its probiotic-gut health claim submission earlier this year, and called on the agency to better define its “methodological and statistical requirements”.

Additionally, in a letter just published by the European Commission, Valio queried the interpretation of certain studies by EFSA’s health claims panel in its 86-study strong dossier that was rejected in February, along with what Valio considered to be damagingly truncated communications between the two parties.

Like other companies such as Danone, Valio has called for pre-submission discussions with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) to help bridge what it sees as a scientific requirement knowledge gap.

Wasteful redundancy?

“It is important for applicants and scientists designing new clinical trials to understand the detailed methodological andstatistical requirements that the Panel [NDA] is applying above and beyond current practices in high qualitypeer review scientific journals,”​ wrote Valio R&D VP Professor Gerrit Smit and R&D development manager, Dr Tuula Tuure.

“In addition, it would be helpful to understand how statistical re-treatment of raw data in well-designed historical trials could be validly applied to avoid enforcing awasteful redundancy in much scientific investment to date, including much work funded by the European Union. Will EFSA release such guidance documents in the near future?”

Valid data dispute

The two company scientists highlighted one 2001 study (Szajewska et al.) where they were confounded by NDA’s conclusion that a rotavirus had not been statistically reduced between placebo and groups taking its Lactobacillus rhamnosus GG​ (LGG) strain.

While they agreed this was the case in terms of before-and-after antigen headcount, the trial had shown a statistically significant reduction in its associated malady – diarrhoea – which they said should have not been disputed due to an absence of data on antibiotic use.

“The absence of data on antibiotic use should not vitiate this finding,” ​they wrote, “as clinical symptoms and the presence of rotavirus antigen together are sufficient for the diagnosis of rotavirus infection.”

The letter calls for more data in non-healthy populations to be utilised in the same way the NDA had indicated that data from trials with patients suffering from irritable bowel syndrome (IBS) could be used as primary material to back claims.

In its opinion​ NDA stated: “In the absence of evidence for an effect of LGG consumption on the development of GI infections in the generalpopulation, these studies cannot be used as a source of data for the scientific substantiation as their resultscannot predict the occurrence of an effect of LGG on the development of GI infection in vivo in humans.”

Tuure and Smit nodded to the consequences of the opinion for Valio and others. “We would like to emphasize that there is ample scientific research available on micro-organisims with beneficial effects on health, accepted already by scientific communities around the world."

"It is important to find ways to exploit this research for communication to the benefit of European consumers. Without such opportunity the European food industry is losing significant commercial potential.”

New avenues in health advancement

London-based paediatrician, Dr Chan Yue Sun, from the Baby & Child Specialist Centre, also wrote to the Commission, urging it to review the NDA negative opinion.

“In its search for health advancement, it is not often that mankind finds a new avenue in its therapeutic armamentarium for health as well as disease,” ​Dr Sun wrote.

“A negative opinion from the Panel in the face of such an abundance of scientific evidence on the most basic health effect of this most researched probiotic strain will derail further research on preventive bacteriotherapy.”

“Therefore I sincerely urge you and the European Commission to take steps to review and reevaluate the scientific evidence supporting this reference strain for bacteriotherapy before this valuable and promising health-promoting option is sidelined and pushed into irrelevance by EFSA’s opinion.”

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