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EFSA accused of industry bias by food policy expert

NOTE: The incisive article below on the food sweetener aspartame precisely nails the problem of scientific decision making at the European Food Safety Authority (EFSA). EFSA accepts weak industry data claiming safety for a risky product, but relentlessly finds fault with and dismisses independent scientific studies that find risk. 

The 2012 study of Prof G-E Seralini and team on GM maize and Roundup is one example among many of a carefully designed and conducted study that found risk but which was dismissed by EFSA. Other examples include shedloads of independent studies showing risks from the plastics chemical bisphenol A, which EFSA dismissed in favour of a few industry-funded studies claiming safety.

This asymmetric scrutiny is applied by EFSA on a regular basis, as confirmed in an interview with former EFSA GMO panel member Prof. Joachim Schiemann, who said of EFSA's scrutiny of the scientific literature on GMOs: "Of course, studies that describe potential negative environmental effects of GMOs are discussed particularly intensively."
 http://www.gmo-safety.eu/news/622.efsa-members-gmo-panel.html

According to a study by food policy expert Erik Millstone and colleagues, this practice is interpreted by the European public as an illegitimate support for the biotechnology industry on the part of the supposedly impartial risk assessor. 

Millstone and colleagues state, "greater institutional care was taken to try to avoid false positives [when a study finds risk from a product that's really safe] than to avoid false negatives [when a study claims safety for a product that is actually not safe]. That implies that critical scrutiny has been applied in an asymmetrical fashion that prima facie seems difficult to reconcile with a precautionary approach".
(Millstone E, van Zwanenberg P, Marris C, Levidow L, Torgersen H: Science in Trade Disputes Related to Potential Risks: Comparative Case Studies. Seville: European Commission; 2004.)    

EFSA is not alone in this practice of asymmetric scrutiny of scientific studies: it's fairly universal among regulatory agencies worldwide. A major problem with EFSA, as Millstone says in the article below, is that many of the experts that write EFSA opinions have direct or indirect conflicts of interest with industry.
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EFSA accused of industry bias over aspartame draft
EU Food Policy
01 Mar 13
Reproduced with kind permission of EU Food Policy
Subscribe:  http://www.eufoodpolicy.com/

The European Food Safety Authority has accepted industry data on aspartame without asking any questions and come up with "flimsy" excuses on why independent studies should be ruled out.

It is also accused of selecting the "evidence" by using excessively restrictive criteria and excluding "vital documents that bear directly on the scientific competence" of some studies.

These are two key criticisms in 67 pages of comments by the leading food policy academic, Erik Millstone, who argues that the ANS [EFSA panel on food additives] draft on aspartame is "deeply flawed".

Prof Millstone, who filed his comments to EFSA by last week's deadline, says: "The ANS panel could only have reached its conclusion that aspartame is safe by implicitly assuming that almost all studies indicating no adverse effects are entirely reliable, even though they have numerous weaknesses.

"By contrast, all the studies indicating that aspartame may be unsafe were deemed unreliable, "even though they sometimes have particular methodological strengths".
He accuses the ANS panel of taking the 80 commercially funded studies at "face value" while being "unremittingly critical" of the 27 independent studies.

"Often these worrying studies are dismissed not because of evidence but on flimsy grounds, by invoking speculative hypothesis without supporting evidence."

Prof Millstone, who has sent his comments to the European Commission and key MEPs including Corinne Lepage (French Liberal) and Kartika Liotard (Dutch Left), is calling for EFSA to discount the report from the ANS panel and convene a new panel which is independent.

Prof Millstone says one possible reason for the “biased" draft is that, of the 17 members of the panel, seven have "direct commercial conflicts of interest" and a further five have "institutional conflicts of interest." 

The academic from Sussex University in the UK who specialises in food policy calls on EFSA to review "all the evidence, not just some of it" and to make the criteria used both explicit and consistently applied.

Commission responsibility

"The European Commission and the European Parliament should also take responsibility for ensuring that EFSA acts properly to protect consumers rather than assisting the food and chemical industries."

Prof Millstone himself submitted a list of 30 documents for the ANS panel to consider but says the panel only addressed four of these and, even then, "fails to address the clearest of implications".

He argues that the panel has included all dossiers by the original applicants within the scope of its review but ignored those from independent people such as himself, some of which focussed on the shortcomings in the testing by GD Searle, the original applicant.

Prof Millstone's comments follow the scathing attack on the draft by Reseau Environnement Sante last week. He shares its strong criticisms of the way the panel disregarded the three studies by the Ramazzini Institute linking the low calorie sweetener to cancer.

He agrees there was a high rate of respiratory infection in the Ramazzini rats but says the rates of infection were "not significantly different" between the rats fed aspartame and those in the control group.

"Therefore the rates of infection cannot account for the dose-related increase in cancer evidence, and do not provide sound grounds for discounting the findings."

He acknowledges "imperfections" in the Ramazzini studies but says "all studies are characterised by some imperfections". 

The study was more sensitive than most and, therefore, less likely than conventional studies to general false negatives or false positives, a fact that the panel did not acknowledge.

He is also highly critical of the way EFSA dismisses the Halldorsson study, which linked pre-term babies to consumption of artificial sweeteners.

As artificial sweeteners other than aspartame were used in some drinks, the premature delivery of babies cannot be wholly attributed to aspartame, he says. 

"But the EFSA panel interpreted it as it if had no bearing on the risks that aspartame might pose, even though in Denmark artificially sweetened drinks are most commonly sweetened with aspartame."

Like RES, he notes that the panel found the design and large size of the study were major strengths but still discounted the results. He says EFSA should have called for follow-up studies.

Prof Millstone also reviews a huge number of recent independent studies on aspartame, arguing that the panel is insisting on "positive evidence of harm set very high" whereas for negative studies it merely "accepts plausibility".

In the document, Prof Millstone makes extremely detailed comments and has offered to travel to Parma to discuss them with EFSA.

His comments alone would appear to require a much longer discussion than the one-day meeting EFSA is planning for everyone's comments.