Adam Smith

Science and Communications Officer, ANH-Intl

Clearly responding to recent criticism of its working methods, including serious and multiple charges of conflicts of interest on its expert panels, the European Food Safety Authority (EFSA) held a public meeting on Wednesday 12th October. Unfortunately, this golden opportunity to turn over a new leaf was squandered – in fact, the meeting felt to us like a classic cover-up. But with EFSA more sensitive to criticism than ever, now is the time to increase the pressure. Get involved and help us to shine a spotlight on EFSA!

An Authority adrift

Without a doubt, the ‘good ship EFSA’ has been taking on water in choppy seas. Many saw it as an encouraging sign when the Agency announced a ‘consultative workshop on [its] Independence and Scientific Decision-Making Processes’ scheduled for 12th October in Brussels. Interested stakeholders, including ANH-Intl, were given the opportunity to question officials not only from EFSA, but also from the USA’s Food and Drug Administration and the UK’s Food Standards Agency. Underlining its professed commitment to, “Strengthening the way in which the Authority assures independence and transparency in its work”, EFSA has been working on a draft Policy on Independence and Scientific Decision-Making Processes, to be unveiled at the workshop. Sounds very positive, we thought, and armed with optimism and some relevant questions, we took the trip to Brussels.

Little expense spared

EFSA certainly appeared to be taking the issue seriously. Held at boutique venue The Hotel – starting average room rate: EUR215 per night – the workshop was professionally recorded for the accompanying webcast, with an audio-visual crew that would have done a middle-ranking rock group proud. Attendees were spoilt for choice in terms of EFSA-related reading material, available in both English and French. The meeting’s moderator was UK broadcast veteran Vivienne Parry, and everyone was treated to some delicious food and wine. Obviously, there is some wriggle room in EFSA's EUR80 million per year budget.

We were pleased to note that EFSA’s most vocal opponents were present, including Greenpeace and Corporate Europe Observatory (CEO) in addition to ANH-Intl. However, we couldn’t help but wonder whether all this window dressing was designed to take EFSA’s critics off guard, but decided it was far too early for cynicism. 

EFSA independence workshop in progress at The Hotel, Brussels, 12th Oct 2011

Building trust in science the EFSA way

Opening speeches came from EFSA chief Catherine Geslain-Lanéelle and Kartika Tamara Liotard MEP, a previous critic of EFSA, who emphasised that the issue of public trust is especially important for European Union (EU) agencies like EFSA: “Without public trust, EFSA’s decisions become hollow and lose their authority”. Continuing the theme, the morning session consisted of presentations on Trust in science: what are the basic ingredients?, followed by a panel discussion. We were most interested in the afternoon session with its three interactive discussions, and particularly the first panel topic, Quality of science. 

First up in the morning session was Professor Ortwin Renn of the University of Stuttgart, and his thoughts on ‘Science and society: public engagement and confidence in science’. He was specifically concerned with, “When scientists are mandated or asked to give advice to public policy makers”. His suggestions were sensible: independence, i.e. freedom of scientists from external influences; fairness in representing interests, as opposed to neutrality or disinterestedness; quality control through mechanisms such as peer review; and transparency of working methods, among others. Prof Renn also addressed the challenges and potential solutions for scientific advice in policy-making, before ending on an Aristotle quote very dear to ANH-Intl's heart: “To progress in knowledge and action means to doubt what conventional wisdom suggests”.

Wadge of dishonour

The morning continued with a presentation 'Explaining the scientific process' from Andrew Wadge, Chief Scientist at the UK's FSA. “We estimate that the numbers of people in the EU who get food poisoning runs into several millions,” he began. This situation, “Can damage trust and confidence in food safety – and the processes in place to protect consumers.” However science, believes Wadge, can play a role in rebuilding that trust.

In outlining how science might go about this, he began, “Science enables us to eat safely because our risk assessments are based on firm scientific principles”. This may be true, but as we have been pointing out for a long time, if those principles are not tested and validated against real-life experience – as is the case with the risk-assessment model being used to develop MPLs – they become meaningless. Furthermore, Wadge believes that, “Science is an open process...Scientific understanding progresses not through dogma, but through open challenge and peer-review”. Fine sentiments, certainly, but MEPs who challenged EFSA on some of its decisions on health claims earlier this year may wonder about EFSA's lack of dogma and willingness to accept criticism.

Wadge displayed the classic, patronising 'we know best' attitude of the bureaucrat – we could almost feel his paternal hand patting us on the head at times: “The fact that [complex dioxin science] is open to scrutiny by those who do understand gives us reassurance,” for example. This attitude has obvious dangers when it comes to new and unproven technology like genetically modified (GM) food, of course. While Wadge correctly observed that, “Science cannot prove...that a particular GM food is safe,” his prejudices – and by extension, those of the FSA and EFSA – were obvious for all to see. “We can use the information on its composition and metabolism in humans to conclude that it is as safe as its conventional counterpart...many millions of meals containing GM food have been eaten without apparent harmful effects.” But this conclusion is possible only through deliberate ignorance of the huge amount of scientific information to the contrary. What kind of attitude is this for a Chief Scientist, let alone a food safety regulator?

Wadge also introduced a theme that cropped up throughout the day. “I have no problem with industry-funded research, provided it is subject to the same peer review requirements [as independent research]...it does not make the research or the scientists tainted.”

Hmmmmmmm.

Before leaving Wadge in his odd bureaucratic bubble, where scientific evidence only exists if it agrees with some official worldview, we have a quiz question for you, our esteemed readers. Wadge believes that, “Decisions to ban the use of Bisphenol A [BPA] in certain products are not justified on scientific grounds alone.” Can you suggest any other criteria that should be used when considering a ban on BPA, a substance about which the FDA has, “Some concern about the potential effects...on the brain, behavior, and prostate gland of fetuses, infants and children” and is considering banning? Tea leaves, perhaps? Casting runes? Animal intestines? Answers on a postcard, please.

Managing EFSA's independence and the FDA

Martijn Groenleer from the University of Delft next gave a presentation on 'Managing independence of scientific authorities: the case of EFSA'. His point was that, while authorities like EFSA's independence from both industry and non-governmental organisations is important, too much separation may actually be detrimental. Why? Because the authorities initially have less information than those they wish to regulate, such 'information asymmetry' could be increased if the parties don't talk to each other. Groenleer's solution is a system of 'institutional autonomy' for EFSA, with a particular structure of management boards, committees and panels receiving advice from experts and 'other actors'.

Next, we were interested to hear the point of view of Murray Lumpkin of the FDA, who presented some 'Learnings from an international perspective'. Unfortunately, Mr Lumpkin rattled through so much information in 15 minutes that his presentation was rather a blur. What was clear from his description of how the FDA has approached the issues of openness, transparency and conflicts of interest, however, is how similarly the FDA and EFSA are already working – and that this process looks set to continue and deepen. Mr Lumpkin said that he, “Always enjoys my time in Brussels” with “my colleagues at EFSA”, and believes that these issues are, “Not unique to Europe – it's something with which all of us around the world struggle with”. This 'coming together' of EU and US regulators is something we have been observing for some time.

Round table discussion

The presentations were all very well, but we began to get a flavour of the meeting during the subsequent discussion. Dr Verkerk asked an important question regarding the tolerance of risks relating to food: “How do you create a system whereby you can validate the quality control system [in order to] prioritise risk without allowing politics to focus a huge amount of attention on [issues of relatively little importance], such as vitamins and minerals, without omitting the big issues, such as the intolerance that so many have for wheat and dairy products?”  

In his answer, Andrew Wadge talked about identifying parts of the food chain that present a particular risk to public health; he used the example of Campylobacter contamination in chicken. Nothing about the actual topic of our question at all! In this neat piece of avoidance, he was ably abetted by the moderator, Vivienne Parry, of whom more later.

EFSA's new policy on independence and scientific quality

For EFSA, the unveiling of its new draft Policy on Independence and Scientific Decision-Making Processes was one of the big events of the day. It's a shame, therefore, that they didn't choose someone with a more dynamic presentation style to give the speech. Dirk Detken, Head of Legal and Regulatory Affairs, gave a presentation rich in information but lacking in star quality. For us, now is not the time for a thorough analysis of the new Policy, but we shall doubtless return to it at a later date.

Scientific quality at EFSA

After a very agreeable lunch, we returned for the session we were most interested in: the interactive discussion on 'Quality of science', chaired by Vittorio Silano, Chair of EFSA's Scientific Committee. The format of these sessions involved three presentations on the relevant topic, the speakers having contributed to the consultation process leading up to EFSA's new draft Policy, after which questions were taken.

In brief, the three presentations involved: Didier Jans of FEFANA (EU Association of Specialty Feed Ingredients and their Mixtures) basically saying what a great job EFSA is doing; Dr Christoph Then of Testbiotech giving a hard-hitting overview of conflicts of interest and other corruption at EFSA; and Jan Schlundt of Danish Technical University proposing that conflict of interest is a simple matter of economic interest, in contrast to the attitude of previous speakers.

The ensuing discussion, unfortunately, did not shed much light on how EFSA can guarantee the quality of science upon which it relies, partly because the topic of conflicts of interest kept coming up. However, that was not the only problem.  Dr Verkerk tried to ask an important question about scientific validation: “When you separate conflict of interest, you still don't have a mechanism to guarantee good science. What is desperately missing from the current framework is some methodology that validates scientific evidence empirically. We have a situation now where one of the reasons that people are very frustrated is that they see no health claims granted for probiotics, they see not a single berry fruit having the capacity to make an antioxidant claim, and there is copious evidence available that these things actually have specific functions in the human body.” At this point, the moderator – who elsewhere seemed remarkably familiar with the chemotherapy drug Avastin – interrupted with, “Well, that's the advert for goji berries over with!”

Dr Verkerk continued: “My background as a scientist was about developing models that you then test against reality, and that seems something that, so far, has been missing...I'd like some views on that.” This was a crucial intervention that went to the heart of why the model being used by EFSA to develop MPLs is so flawed – and yet the moderator ignored it entirely, immediately asking for another question! Check it out for yourself on the webcast – Dr Verkerk's question begins at almost exactly the 4-hour mark.

The rest of the discussion didn't go any deeper into the quality of EFSA's science.  In fact, the representative of the BfR, the German regulators, ended the discussion by declaring that since each scientific paper is a contribution to the overall picture, no further discussion was required.

EFSA obsesses about safety — but not about health

Conflicts about conflicts of interest

If the first afternoon session was disappointing, the next two sessions descended toward farce.  The second interactive session was on 'Governance, openness and transparency', and to EFSA's credit, they had asked Nina Holland of Corporate Europe Observatory (CEO) to speak.

However, while CEO is one of EFSA's sternest critics in the area of conflicts of interest, it has little knowledge on EFSA's governance and openness.  Ms Holland's presentation was a damning look at EFSA's history of clear conflicts of interest, and was the only one of the three presentations in the second session that added anything useful to the day's activities.  The audience agreed, for in the following discussion, most of the questions were about conflicts of interest!  But, of course, Ms Holland's presentation actually belonged in the final interactive session – which allowed the moderator, Ms Parry, to kick questions about conflicts of interest into the long grass.

The final session of the day proved the effectiveness of this strategy.  The panel on 'Assessing interest' was populated by Rainer Wittkowski of BfR, the German risk assessor that is closely linked to EFSA and is the keenest advocate of low MPLs, Nico van Belzen of the Institute of Life Sciences International (ILSI) — the Big Food front group which can count BASF, Bayer, Coca-Cola, Dow., Kraft, McDonalds, Monsanto, Tate & Lyle and Unilever among its European members, and whose name is connected with the some of EFSA's conflict of interest scandals — and Camilla Udsen of the European Consumer's Organisation, who are heavily funded by the European Union.

Unsurprisingly, we learned little of note about EFSA's supposed drive to eliminate conflicts of interest from such a panel.  It was chaired by Hubert Deluyker, Director of Risk Assessment and Scientific Assistance at EFSA, who was very adept at stonewalling important questions.  Ms Holland of CEO asked him, “[With regard to] one of the concrete examples I gave, the vice-chair of one of the expert panels works for a lab that has been funded by Nestle since 2005, and by other industry associations that make flavours.  Why is this tolerated?”  His reply?  “The information that you presented today...has been submitted to EFSA previously.  There is nothing new, unless I am missing something...it's also important to make sure that the audience knows that we have procedures in place.  We don't all of a sudden need to invent procedures, we have them, we utilise them...it's a communication issue.”  One strong impression we took away from the day was that many people within EFSA seem to believe that simply declaring conflicts of interest solves the problem – which, of course, it does not.

Conclusion

In terms of getting useful or enlightening answers from EFSA, this was a bitterly disappointing meeting.  However, it offered yet more information on how EFSA is prepared to deal with criticism.  What it has done, in short, is to spend a fair whack of cash – provided by generous EU taxpayers – on a well-run, well-organised public meeting.  It has invited some of its fiercest critics, some of whom were even given a platform at the meeting, giving the impression of willingness to address its past problems.

The devil, as always, is in the detail.  Questions of vital importance to millions of people who work in and depend upon the natural healthcare sector were simply ignored or blown aside with hot air.  Experts in EFSA's conflicts of interest were shunted off into the wrong discussion panel, allowing the moderator to drive the discussion down avenues more comfortable to her hosts.  And the panel on conflicts of interest, a topic of crucial importance to the audience, was stuffed with EFSA cronies and an organisation responsible for corrupting EFSA in the first place!  You couldn't make it up if you tried.

We'll leave the penultimate words to Catherine Geslain-Lanéelle, from her opening speech: “While two-thirds of [Eurobarometer] respondents agreed that science and technology can improve their lives, 58% thought that scientists cannot be trusted on controversial scientific and technological issues because of their associations with industry...Nearly three-quarters of respondents regarded scientists as trusted sources of information on food-related risks, however less than half agreed that this scientific advice is independent of commercial or political interests.”

While EFSA keeps green-lighting genetically-modified foods, telling European citizens that aspartame and BPA are safe – while at the same time rejecting health claims for the vast majority of healthy foods — the status quo is unlikely to change in a hurry.

Call to Action

Write to your Members of the European Parliament, expressing your dismay at EFSA's unwillingness to address the issues that bring it into disrepute.

Or contact EFSA directly - address your letters to:

Ms Catherine Geslain-Laneelle

European Food Safety Authority

Largo N. Palli 5/A

43121 Parma

ITALY

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