OmniAct Mango – A fortified Mango (Mangifera indica) extract with high anti-oxidant potential
Ajinomoto NaturalSpecialities
Lina Paulionis, senior scientific and regulatory consultant at Intertek Cantox’s Canada bureau, made the controversial assertion at the Probiotic Summit in Brussels yesterday in response to an exasperated presentation from veteran probiotic academic, Professor Ger Rijkers.
The Dutch researcher compared EFSA’s dismissive treatment of probiotic science – no probiotic has yet won a positive opinion from the agency - to a roulette game where there were no winners because every number was ‘0’, prompting Paulionis to question the peer-review publishing process.
Paulionis acknowledged the EU system was tough in a presentation that compared it with US and Canadian regimes, but said EFSA’s hard line was also shining a light on failures in peer-review mechanisms.
“I think EFSA has uncovered a big flaw in the peer-review process and really uncovering limitations in peer-reviewed publications,” she said, adding, “I think it is overrated in the sense that peer reviewers are not given any guidance on what exactly to critically appraise a manuscript for…”
That said, Paulionis said good science did exist and was capable of winning health claims under the EU nutrition and health claims regulation (NHCR), if dossiers are compiled in the right way.
7 comments (Comments are now closed)
Good Science, you know it makes sense
So, thinking as someone with a sceptical scientific turn of mind, with an interest in politics & economics, have I got this right?
Politicians, being good people, care for the economy & the population's health by insisting on Evidence Based Medicine.
EBM proponents insist on Good Science.
..Good Science may rule out all long-standing common experience, all clinical outcome studies, any "Un-Scientific" observations, as unreliable, as "unacceptable evidence".
..Good Science accepts only the one plank of EBM, the RCT. Obviously the very best plank, and you need no more than one plank to build a bridge.
..Good Science that accepts only the DBPCRCT, with narrowly defined hypotheses, published & peer-reviewed in major journals.
...This is the Placebo Controlled Trial, depending on the Placebo, a substance that has No Effect. Except for the Placebo Effect, that is. Which is not fully understood by Good Science.
....(The Placebo Effect that is, which, since only recently, we find it would be unethical for doctors to use. And unprofitable.)
This is the Placebo Controlled Trial, where you expect to see Regression to Mean, a herd effect that only occurs for deadly toxins, and for profitable "herd" treatments, but does not apply for holistic treatments (go on, work it out).
This is the Placebo Controlled Trial, where long-term adverse effects commonly do not exhibit themselves, largely because of a narrow definition of "success".
(We know that from long experience, of course. But long experience, we now know, is not Acceptable Evidence. Not Good Science.)
.. Peer-reviewed by, well, by peers who have a vested interest in maintaining their authority, and are often personally or departmentally funded by, oh, the major money-spinners of medicine.
.. And are products of the very systems they seek to maintain.
... In major Journals, independently edited, owned by, oh, the major money-spinners of medicine.
.... Who, very altruistically, often donate large sums to the very best political parties.
So, Good Science nowadays depends solely on this excellent method of Scientific assessment.
Except, it seems, when it doesn't.
Except when someone can be found to stand up and challenge what looks like a positive advance in health Science.
(Science, remember , depends on such challenges to the status quo. Or is it to stopping unprofitable advances? I forget.)
Except when powerful lobbies (and, oh, major money-spinners of medicine) don't actually like the well-published, augustly peer-reviewed DBPCRCTsWNDOs.
Maybe they get a sniff of something there, that might actually make people healthy.
A healthy herd, remember, is very, very bad for their business, especially if it's unprofitable to muscle in, because basic nutritional medicine is not patentable.
And if "alternative medicine" were effective, remember, it would become just "medicine".
Unles it can't be profitably be patented, of course. Then it becomes just "banned".
Have I got that straight?
So, in matters of our personal health, Good Science (& Profits) must rule.
It's for our own good, after all.
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Posted by Bill LaChenal
17 February 2012 | 20h28
Prebiotics to gain recognition
Actually, as a dietitian , Millie should evaluate the benefits of the prebiotic soluble fibre ,Inulin , in the dietary regimen spoken of in the comment below. The cost of this functional food ingredient which induces the acidic gut, is far below that of the transiting , non-indigenous , dead or live , encapsulated, commercially manufactured probiotic strains of bacteria that are being promoted incessantly through all forms of the media. Eventually prebiotics' functionality will be recognized and calmly promoted as soluble fibre that actually maintains a healthy gut and immune system.
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Posted by Larry Whetstone
10 February 2012 | 20h01
Tweedledee Millie thread
Tweedledee's and Millie's divergent opinions highlight the nub of the problem. Millie's years of clinical experience, a form of evidence that was intended to be an important element in healthcare decision-making according to the original definition of evidence-based medicine (JAMA, 1992; 268(17): 2420-5), now apparently counts for nothing. Which other branch of science has so completely divorced itself from observational and empirical evidence? High-quality RCTs are a useful adjunct to the evidence base, but they should not be the sole source of evidence. It's interesting that those that attempt to invalidate clinical experience are very rarely clinicians. Nor are they patients who have experienced major improvements in health that were associated, at least temporally, with an altered nutritional regimen including probiotic supplementation.
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Posted by Dr Robert Verkerk
09 February 2012 | 11h23
Restrictive EFSA criteria act disproportionately against small businesses
One of the great challenges for probiotics is that EFSA's criteria dismiss a huge body of biologically relevant science and require new studies to be conducted. This may be in the reach of some very large companies, but ironically, many of the manufacturers or suppliers of the best quality probiotic products are smaller companies that simply don't have the resources to conduct new studies. Forcing companies to conduct new studies to secure general function claims is, in my view, outside the spirit of generic claims environment that was meant to be represented by the Article 13.1 claims regime. EFSA have used a 'let's make it up as we go along' approach that now makes it impossible for thousands of products that are patently capable of delivering considerable benefits to consumers from being sold with claims to help inform consumer decisions.
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Posted by Dr Robert Verkerk
08 February 2012 | 18h41
Probiotics
The curves and turns of our human digestive tract support an active and diverse microbial ecosystem. The tens of trillions of bacteria aren't just passive transient consumers of food; they interact intimately with our immune system, and are so integral to our health that some scientists have deemed them the “forgotten organ. Into this milieu we, by whom I mean clinicians and practitioners have added probiotics and prebiotics.
Mostly done in good faith, but with little substantive published evidence for their reproducible outcome, certain strains have none the less begun to be identified as compliant messengers that influence outcomes for the better.
The comments that peer review has serious flaws are not without precedent, as most of us know peer review has its positive and negative impact on science and medicine (as well as its share of dubious papers). To dismiss out of hand the work of scientists across the world, who are researching this rapidly evolving arena on the basis that EFSA have somehow identified a flawless mechanism for identifying validity of clinical application is equally as bizarre a statement.
Probiotics and their effects are very difficult to demonstrate consistently across nations and different conditions by nature of the great variable – what the individuals eat, as every mouthful of food will impact on probiotic functionality. Hence the somewhat contradictory outcomes sometimes reported. The differing gene sets both human and bacterial will also play confounder from time to time.
As a practitioner using probiotics as part of a therapeutic input into a general practice of complex GI problems, I have found them to mostly be helpful and at worst benign. Assuming a small exogenous bacterial load can induce adequate functional change without the consideration of food source, will I suspect continue to limit consistency in terms of research data, but should not diminish the value of work already undertaken and the future applications.
Health claim assessment by EFSA focuses on defining given foods/probiotics, assessing their health relationship, and evaluating relevant studies with an emphasis on controlled human intervention research. Challenges include the focus of claims on healthy populations, as most intervention studies have been conducted among patients. A further problem attends the risk reduction claim, which requires changes in generally accepted biomarkers reflecting the risk of disease to those that are universally agreed when they do not currently exist.
Mimura, T. et al. Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis. Gut 53, 108–114 (2004).
Amit-Romach, E., Uni, Z. & Reifen, R. Therapeutic potential of two probiotics in inflammatory bowel disease as observed in the trinitrobenzene sulfonic acid model of colitis. Dis. Colon Rectum 51, 1828–1836 (2008).
Rauch M, Lynch S. The potential for probiotic manipulation of the gastrointestinal microbiome. Curr Opin Biotechnol. 2011 Nov 30
Kolida S, Gibson GR. Synbiotics in health and disease. Annu Rev Food Sci Technol. 2011;2:373-93. Review.
Quigley EM. Prebiotics and Probiotics: Their Role in the Management of Gastrointestinal Disorders in Adults. Nutr Clin Pract. 2011 Nov 29.
Konieczna P, Groeger D, Ziegler M, Frei R, Ferstl R, Shanahan F, Quigley EM, Kiely B, Akdis CA, O'Mahony L Bifidobacterium infantis 35624 administration induces Foxp3 T regulatory cells in human peripheral blood: potential role for myeloid and plasmacytoid dendritic cells. Gut. 2012 Mar;61(3):354-66. Epub 2011 Nov 3.
Vasile N, Ghindea R, Vassu T. Probiotics--an alternative treatment for various diseases. Roum Arch Microbiol Immunol. 2011 Apr-Jun;70(2):54-9. Review
Wang Y, Kirpich I, Liu Y, Ma Z, Barve S, McClain CJ, Feng W. Lactobacillus rhamnosus GG treatment potentiates intestinal hypoxia-inducible factor, promotes intestinal integrity and ameliorates alcohol-induced liver injury. Am J Pathol. 2011 Dec;179(6):2866-75.
Gibson GR, Brummer RJ, Isolauri E, Lochs H, Morelli L, Ockhuizen T, Rowland IR, Schrezenmeir J, Stanton C, Verbeke K.The design of probiotic studies to substantiate health claims. Gut Microbes. 2011 Sep 1;2(5).
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Posted by Michael Ash
08 February 2012 | 16h48
Probiotics
@Millie - unfortunately anecdotal experience is no substitute for well controlled trials.
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Posted by Tweedledee
08 February 2012 | 15h37
probiotics
Actually, as a dietitian, I have found probiotics to be the single most effective supplement or food recommendation in my many years of working. They are excellent for diarrhea, constipation and IBS. It would be sad if they were no longer an option
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Posted by Millie
08 February 2012 | 15h00
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