Research and subsequent media reports, claiming that the labels of certain locally-produced probiotic products contain false information, have caused a lot of confusion among consumers. But the claims made by the researchers and the media are misleading and wrong. In this article, we bring you the full story.
Right now, probiotics are hot news in South Africa. Newspaper articles featuring sensational headings, such as, Health supplements ‘falsely labelled’ (Sunday Times, 22 February); Problems around probiotics (Pretoria News, 26 February); Bacterial battle hots up (Pretoria News, 4 March) and Bitter battle over probiotics (Pretoria News, 18 March) have appeared in the popular press in recent months. Many more similar articles are bound to be published too.
Dieticians have recently received a letter via e-mail from Thebe Pharmaceuticals and the Department of Health (DOH) about this matter, and aggrieved probiotic manufacturers have published a rebuttal advertisement in the Sunday Times.
What is this storm in our scientific Petri dish all about? And what do health professionals believe? Do probiotic products sold in South Africa contain viable organisms at levels specified on labels? Or are these products ineffective and contaminated?
At this point it may be useful to review the sequence of events that led to this furore.
The original article
An article entitled An evaluation of nine probiotics available in South Africa, August 2003 was published in the February issue of the South African Medical Journal (SAMJ). This article was written by Drs Elliott and Teversham.
In their introduction, the authors point out that five new commercial probiotic products were launched in South Africa in the last two years and because of the finding that probiotics sold in Europe and the USA, when analysed “have shown poor correlation between label claims and actual contents”, they were motivated to carry out an evaluation of nine probiotic products available on the South African market in 2003.
The following products were evaluated:
- BioPro Reuteri straws
- BioPro Reuteri chew tabs
- Bioflora Combiforte capsules distributed by SciPharm
- Pharma Dynamics Culturelle sachets
- Pharma Dynamics Culturelle tablets
- Bioflora Infantiforte capsules distributed by SciPharm
- Lacteol Forte capsules distributed by Mirren
- Lacteol Forte sachets distributed by Mirren
- Cipla Medpro Lactovita capsules
All nine products had expiry dates ranging from June 2004 to January 2006.
According to the paper, sampling was done by “an independent retail pharmacist” who ordered a selection of probiotic products via his wholesale suppliers. The authors class this method of sampling as “random” as there is no way to “predict the batch”.
Subsequently the samples were kept refrigerated at 4 degrees Celsius until collected by a courier and were then sent overseas “under cold-chain conditions” to the University of Ghent in Belgium.
The paper states that samples were analysed and evaluated at the Laboratory of Microbiology of the University of Ghent. Few details of the methods used for the analyses are given and most readers who are not microbiologists would not be able to judge if these methods are either appropriate or adequate to identify various types of micro-organisms or determine viable cell counts.
Elliott and Teversham published the following results:
- Only three of the nine products contained bacteria indicated on the labels, namely the BioPro Reuteri straws and Reuteri chew tabs (both containing Lactobacillus reuteri), and the Bioflora Infantiforte capsules (containing Bifidobacterium infantis);
- The Bioflora Combiforte capsules, only contained two organisms L. acidophilus and Bifidobacterium infantis, of which only the former was listed on the label - the authors classified the contents of this product as only ‘partially correlating’ with the label;
- The Pharma Dynamics Culturelle sachets and tablets “showed no correlation between the label claim and the actual Lactobacillus and Bifidobacterium species identified.” Instead of the Streptococcus thermophilus listed on the label of the sachets, Enterococcus faecium, a potential pathogen, was found.
- Cipla Medpro Lactovita capsules contained the yeast Saccharomyces cerevisiae and no lactic acid bacteria as listed on the label, could be found.
- Lacteol Forte capsules and sachets distributed by Mirren did not contain any ‘measurable’ organisms. According to the authors, the package inserts of the Lacteol Forte products list the contents as ‘killed bacteria’ and argue that they should not be sold as probiotics.
- Only five of nine tested products “contained sufficient numbers of organisms to have probiotic potential”.
Elliott and Teversham conclude: “The results of our evaluation clearly show the limitations of the current system of evaluation of probiotics for registration and the lack of post-marketing surveillance.”
Shortly after publication of the this article, Thebe Pharmaceuticals – the manufacturers of BioPro Reuteri straws and chew tabs, two of the three tested products that were found to conform to labelling criteria, who initiated and financed the study and employ both Dr Teversham’s wife Sharon as their CEO, and Dr Teversham as their medical adviser – started an intensive publicity campaign to make the results of the study known to the public and healthcare professionals.
At the same time, a press release was sent out to the media and publication of the findings by means of radio interviews was initiated.
On 23 February, dieticians received an e-mail from Thebe informing them about the findings of the study, “for their patients’ sake” and pointing out that their two Reuteri products were found to conform to all requirements.
At the same time Thebe’s representatives visited pharmacies and health shops to make the findings of the study known.
Another letter from Thebe Pharmaceuticals was sent to doctors in which the company reiterates that they “are confident of the validity of the results of this independent analysis by Dr Temmerman at the University of Ghent in Belgium, who received his PhD for his work on the analysis of probiotics.”
The letter goes on to say, “.. in Temmerman’s analysis of nine locally available probiotics the BioPro Reuteri chew tabs and straws came out tops - in the study they were two of only three probiotic products which contained the bacteria indicated on the label and in sufficient amounts to be effective.”
Understandably the manufacturers and distributors of the products named in the SAMJ article were highly incensed that the good names of their companies and the integrity and efficacy of their probiotic products had been publically discredited. Not only were the names of all the manufacturers listed in the Elliott and Teversham article, but the efficacy of their products was questioned. In addition, the article implies that these products were wrongly labelled (i.e. misleading the public) and that at least one of them contained a potentially harmful organism. Strong stuff.
Within days of the publication in the SAMJ, the media picked up on the implications of the published results and a flurry of articles appeared while radio interviews were held on most stations with BioPro representatives. Bear in mind that this is also the company that produces two out of the three probiotic products that passed the tests with flying colours.
Three of the companies that had their products ‘tested’, namely Bioflora, Cipla Medpro and Pharma Dynamics, reacted swiftly by publishing a statement on Probiotic Products: False Accusations of False Labelling in the Sunday Times of 20 February.
The statement claims that “a well-orchestrated campaign by a probiotic manufacturer, apparently under cover of ‘concern for public health’, is using a scientifically flawed article to discredit competitors’ products and undermine public confidence in probiotics in general.”
The three companies then assured the South African public and Healthcare Professionals that their respective probiotic products are of the highest quality, conform to international standards, and that the label claims have been independently verified.
The companies point out that the above mentioned study has “been evaluated by specialists in the field and found to be inaccurate and fundamentally flawed” and that “the authors of the study used questionable methodology, without controls and statistical data (a prerequisite for any scientific publication) and appear to be unfamiliar with the current classification of probiotic bacteria.”
Dr Ela Johannsen – owner of Bioflora, which developed and manufactures Infantiforte and Combiforte in co-operation with the Agricultural Research Council (ARC), is one of South Africa’s leading microbiologists, with 30 years of experience in the field and who is also the author of over 75 scientific papers – submitted a letter to the editor of the SAMJ which was published in March.
In this letter, Dr Johannsen points out the conclusions published by Elliott and Teversham are “fundamentally flawed” and “highly questionable”, that the study lacks basic statistical data and gives “an overall impression of being hurriedly prepared, with methodology incompletely described and the results, as well as the conclusions not thoroughly considered.”
Dr Johannsen is of the opinion that the paper should never have been accepted for publication particularly as the scientific methodology was at best questionable.
She has suggested that the SAMJ should invite specialists in the field of probiotics to evaluate her comments and if these specialists confirm the points she has made, that the SAMJ should officially revoke the findings and make a public apology.
Exposure for the sake of advertising?
The authors of this controversial study have stirred up a great deal of ill feeling, which could easily have been avoided if they had not published the brand names of any of the tested products or the names of the manufacturers and distributors, or used the results for advertising purposes.
A number of nutrition research papers have been published in the past which examined potentially controversial micro-organism-related subjects, including, for instance, the viability of micro-organisms in yoghurt (Lourens et al, 2000), the prevalence of Listeria species in SA dairy products (Wnorowski and Bergman, 1993), the presence of food-borne bacterial pathogens in meat (Vorster et al, 1991), and contaminants in fruit yoghurts (Jordaan and Bester, 1995). However, none of these studies published brand or company names.
Antoinette Booyzen, an Assistant Director in the Directorate: Food Control, of the Department of Health has informed dieticians that the findings of the paper published by Elliott and Teversham should be “treated with caution” until they have been critically evaluated and the results of such an evaluation have been accepted.
In my opinion, one of the fundamental questions that must be asked is what value publication of potentially flawed information can have for the public, other health professionals or dieticians. Any researcher knows that it is fundamentally important to establish the facts before going to print with your findings. Moreover these facts must stand up to the scrutiny of peers and other specialists in the field.
If the facts or findings of any such investigation are sensational and the methodology and criteria used are beyond reproach then the scientific community – including dieticians and health professionals – will welcome that information and be guided by its findings.
But if the information itself is questionable and the methodology and criteria used can be doubted then my question is simply, why risk publishing the article in the first place?
Perhaps it could be argued that, like many publications all over the world, the pursuit of a sensational article can and does influence the decision to publish. But as any publisher or editor will assert, if the facts are in doubt, leave them out.
Of course it’s hardly surprising that Thebe Pharmaceuticals used the findings to promote sales of their products. Who can blame Thebe for taking advantage of the marketing opportunity created for them? The methodology may be questionable but the principle is simply to make sales. What I find disturbing is that a supposedly scientific article can be used to justify one product and undermine others.
Of course there are arguments and counter-arguments being presented by the affected parties in the probiotics saga and we will have to wait and see what transpires.
It remains a pity, though, that so much confusion has been created in the minds of the public. After all, it is these consumers who can benefit from the true value of a number of different probiotics products.
References used in this article are available from Dr Ingrid van Heerden on request.
Published in Inside Out, Vol 1, No 1, April to June 2004.
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