Dr Summers appeal argument

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Posted 18 May 2010

Part A: Heads of Argument – To be read at the appeal as I was unable to attend the hearing

Part B: The essential written argument against Dr Beverley Summers being re-instated as a “credible expert” for purposes of substantiating products for Homemark.

[note note_color=”#f9fca8″]Documents submitted by Dr Beverley Summers Her argument in favour of her re-instatement as a “credible expert” Her response to my argument against her being reinstated. Her substantiation of Slim Coffee with Caralluma fimbriata (1 MB pdf file)[/note]

Part A: Heads of Argument
[non-essential aspects removed]

15 March 2010

Dear Mr Makgato and Jude King: 

Re: Homemark Slim Coffee / HA Steinman / 12988: Final appeal 

I am unfortunately not able to attend the appeal hearing and no disrespect is intended. As I am unable to personally make representation, I have synthesised the essential rationale as to why Dr Beverley Summers should not be regarded as a “credible expert” by the ASA:

  1. In the Peel Away the Pounds arbitration, Dr Summers’ substantiation for the product was not simply dismissed because of a minor matter of a difference of interpretation between experts of the conclusions of the study, but that every aspect of her assessment was rubbished – not only by the two arbitrators but by four other experts.
  2. Dr Summers substantiated two products for Homemark months or years after the USA Federal Trade Commission deemed them to be “scams” based on scientific interrogation.
  3. Other critical points, detailed below, and among other:
    1. Dr Summers substantiation of Homemark products places the average consumer at great risk: health and financially.
    2. Dr Summers, as a pharmacist and an expert, is expected to guide the ASA into making the correct decisions, and therefore to comment if the ASA’s decision is inconsistent with her substantiation, and not to claim that it is either Homemark’s or the ASA responsibility for making a decision that she was not exact on, i.e., the claim that she stated “could” and that the ASA misinterpreted her substantiation as “would” – a claim I will show to not be true.

I need to stress that I have not claimed that Dr Summers is not a credible expert regarding cosmetic products, or in other areas where she has proven expertise, but that her expertise and/or credibility regarding the substantiation of weight loss products are sorely lacking.

I am aware that this letter serves as my verbal submission, i.e., heads of arguments, for the appeal. I will try to be as brief as possible, but Dr Beverley Summers, in her letter submitted for the final appeal, and in her deconstruction of my letter to the ASA dated 08 December 2009, made a number of points that need to be adequately addressed and rebutted. 

A. Peel Away the Pounds Study and arbitration

 Dr Summers makes the claim that she stated that this product “could” and not “does” result in weight loss and that the ASA were responsible for this misinterpretation. She also states “the main difference between the arbitrators report and my opinion was with regard to the statistical interpretation” and “[I]f the report is read carefully it will be seen that they criticise very few of my statements apart for the area of statistical significance”. She also claims that “[T]he arbitrator’s conclusion was not that I was in error, but that they “do not agree with the ASA ruling of October 2005”. [Point 1: Appeal letter 6 February 2010]

This is simply astounding and disingenuous. The arbitrators attacked every aspect of her substantiation, from the size of the study, the methodology, the interpretation of the statistics and the conclusion.

The arbitrators either made independent comments, or agreed with the opinions of the 5 experts who had evaluated the study (four blinded to the product, and Prof Roy Jobson), stating “[W]e support the following statements”. One of the arbitrators, Dr Rene Blaauw is now a full professor at the University of Stellenbosch.

I have selected a number of statements from the arbitration report to illustrate this: 

  1. 1.”Although the full protocol for the study was not received, we do not believe that the baseline diet and lifestyles of the two groups were measured and compared and could therefore had an effect on the results.”
  2. “The design and results of the pilot study is flawed by poor design, inadequate numbers, short duration and no statistics being performed between the two groups taking part (Letter Prof Jobson, 23 February 2006)”
  1. “Comparisons cannot be done within groups to prove statistical significance. The only valid comparison is between the 2 groups and looking at those results, there are no significant differences between the 2 groups for weight loss at the end of either week 1 or week 2 (Letter Dr Lombard 21 September 2006)”
  1. “The results of the intervention group were not compared to that of the control group and hence cannot be used. Also the study was too short to draw conclusion on for a weight loss trial (Letter Prof Venter 4 October 2006)”
  1. “The study results are inconclusive due to methodological problems (too small numbers, too short duration and properly randomised allocation of groups) (Letter Dr Charlton 9 October 2006)”
  1. “It is not possible to make weight loss claims based on the results of a study with so few participants and of such short duration (Letter Dr Steyn 10 October 2006).”
  1. “No measurement were made regarding any of the other claims, namely;
    ‘increases metabolism’

    ‘burns fat’
    ‘suppresses hunger’” [My emphasis]
  1. “The results of the pilot study do not provide evidence for the efficacy of the system as a whole because the intervention between the 2 groups differed and the compliance to the diet programme was not assesses nor commented upon (Letter Prof Jobson, 23 February 2006)”
  1. “No mention is being made to the 30 and 33% respectively of study participants that actually gained weight during the 2 week study (Letter Prof Jobson, 23 February 2006)”
  • 10.   “The pilot study does not meet evidence-based criteria in terms of study design, duration, monitoring and most importantly, statistical interpretation of the results”
  • 11.   “The composition of the meal replacement drink and the efficacy thereof should have been discussed, since this is one of the 2 main differences between the treatment and control groups”
  • 12.   “The statistical significant of the results was not correctly calculated and interpreted and therefore not usable. The results of the pilot study are thus not correctly interpreted and the claim for weight loss is not adequately substantiated”
  • 13.   “Making claims based on the results of the pilot study is misleading and incorrect. If the patches work through a placebo effect (according to the expert) then marketing the product with the strong emphasis on the patches (revolutionary treatment) is misleading and incorrect”
  • 14.   “Although the system is marketed as a whole system in South Africa, all the evidence provided is based on the effect of iodine absorbed through the patch. There is, therefore, no difference between the local system and the one used in the USA. It is only a playing with words”

Point 7 above is particularly significant, for Dr Summers is quoted in the ASA ruling of 24 October 2005 as stating that “the research material evaluated supports weight loss claims as well as claims to the effect that the system as a whole, when used at the recommended dosage, boosts energy levels and burns fat.” (Ruling 24 October 2005) Furthermore, Dr Summers’ stated in her substantiation: “ . . . statistically significant average weight losses . . .”. Based on Dr Lombard’s, Prof. Christine Venter and Dr Nelia Steyn, this would appear to be evidence of a lack of expertise in her evaluation of the statistical analysis included in the study. This is further corroborated by her nonsensical statement in her comment in the Notice of Meeting documents where she wrote: “Academic Exercise: Had the size of the groups been doubled (18 in control and 20 in test) and the data been of the same orders of magnitude as in the study, then the group differences would have been statistically significant”. This statement alone is incredulous and if anything, would result her failing a statistics exam.

I also wish to draw attention to the appeal panel that I had previously canvassed the opinion of Dr Beverley Summers substantiation from 4 local but internationally recognised experts who assessed the study (blinded to the name of the product) which stated among other: 

1. “No intervention effect is found for BMI which will be a difficult change to show.” and “The effect is minimal and probability of no clinical value. No long term claim can be made on this data.” [My emphasis]

Dr Carl Lombard, Biostatistics at the Medical Research Council

21 September 2006 

2. “In summary, the results of this trial are inconclusive due to methodological problems associated with the design of the trial and analysis of the data.

She does note in her introduction “Based on the information supplied to me (5 pages in total), the methodology of the trial is not adequately described.” In other words, she actually points out that the study was flawed from the outset in that it did not adequately set out the parameters or methodology adequately. [My emphasis]

Prof. Karen Charlton

Research Fellow, Chronic Diseases of Lifestyle Unit, Medical Research Council

Cape Town

9 October 2006. 

3. “In the statistical analysis, the mean weight loss in the intervention group was not compared to weight loss in the control group. Therefore, nothing can be concluded from the results” and “[T]he study was extremely short (2 weeks). Hardly any conclusions can be made from such a short weight reduction trial.”

Prof Christine Venter

School for Physiology, Nutrition and Consumer Sciences,

North-West University

4 October 2006 

4. Although the weight loss appears to be significant in statistical terms it is in fact rather insignificant in real weight terms. Overall a group of 10 adults lost about ½ kg on average over 2 weeks. This could be solely the effect of the increased physical activity…and in my view is the most likely explanation. No reputable scientist would make any “weight loss claims’ based on such a small study of such a short duration. [My emphasis]

Dr Nelia Steyn (BSc. Diet Hons, Postgrad dipl. Hosp diet. MSc. MPH, PhD)

Chief Specialist Scientist

Chronic Diseases of Lifestyle Unit

10 October 2006 

I stated in a letter to the ASA dated 09 October 2006, “[I]t is evident from the summaries of 4 South African experts in the fields of statistics and nutrition, that Dr Summers’ lack of expertise has allowed Homemark to continue making claims for the worthless product Peel Away the Pounds. It confirms the opinion of the USA Federal Trade Commission’s (FTC) panel of five experts which resulted in the FTC prosecuting the manufacturers and marketers of Peel Away the Pounds in the USA.” In other words, by Dr Summers substantiating this product based on “minimal effects” and “probability of no clinical value”, she has directly impacted on the health and welfare of South African consumers. Yet Dr Summers claims to have no knowledge of the FTC ruling, even expressed in this letter to the ASA dated 09 October 2006 (see below).

I raised the issue in arguments to the ASA that the USA Federal Trade Commission had ruled against Peel Away the Pounds and had instituted legal action against the company. The company were financially penalised and the owners precluded them from selling any weight loss products in the future. Dr Summers claims that she did not know these facts (“does not have such correspondence to hand, so cannot comment.”) [Comment A38] Does she therefore claim that these facts that I brought to the attention of the ASA and Homemark, and requesting the substantiators explanation why her substantiation is contrary to these facts, was never shown to her by Homemark? As a “credible expert” does she claim that she never utilised the internet to search for data involving this product? (She points out in her documents that she did utilise the internet for data on other products).

Furthermore, I have it on good authority that she subscribes to DrugInfo (which she acknowledges by pointing out that I allegedly defamed her in this discussion group), and I point out that I posted a comment to readers questioning how she could have substantiated the product when the FTC experts had ruled against the product, and that the company had settled out of court acknowledging that the study was insufficient evidence for claims of efficacy. Yet Dr Summers made no comment on this anomaly. 

Dr Summers does not provide one expert to support her substantiation, contrary to the 4 “blinded” experts I have provided, Prof Roy Jobson, and the results of the FTC panel of experts. 

Therefore one can only conclude that Dr Summers does not have sufficient expertise to evaluate studies, i.e., may be inept, or potentially, that she had purposefully lied. Note, the interpretation of the study was not based solely on data that can be interpreted in various ways – it is significant that Dr Summers made a significant error and the consumer paid the price.  

B. Second unacceptable substantiation: SlimCoffee – First formulation (Citrus aurantium)

Dr Summers writes: “How is it that Dr Steinman brings in a product that is not at issue? [Comment A22 Letter 8 December 2009] This is self-evident, I need to argue that Dr Summer’s expertise and/or credibility in substantiating weight-loss products should remain revoked, and therefore, that as I accept that any credible expert can make an error once, but twice or more is significant. Therefore although I have argued that Dr Summers’ problematic substantiation of Peel Away the Pounds is severely flawed to disqualify her as a credible expert, that I am compelled to point out that as I would have expected Dr Summers to be doubly cautious in her substantiation of a second product for Homemark, i.e., SlimCoffee, yet she once more failed by not displaying due diligence. (I am reflecting on a pattern). 

As with Peel Away the Pounds, Dr Summers appears to not have paid any attention to my arguments that the FTC had ruled against the product (and all its variants) based on a lack of sufficient scientific evidence – and not based on legislative requirements alone. Does Dr Summers claim that Homemark hid this documentation from her as well, and that she did not examine the internet for any data on SlimCoffee (she does admit looking for the research entity, “Horus” and one would assume the search would very likely have brought up the FTC’s ruling). 

I pointed out that the research entity did/does not exist and that the study is therefore false and likely to have been fabricated. Dr Summers did not alter her substantiation, or re-evaluate her substantiation, nor did she attempt to prove that my claims were false. I also want to emphasise that Dr Summers is regarded by the ASA as the “credible expert” and I am not, therefore how is it that I was able to ascertain the true facts and she not? 

Dr Summers also argues that synephrine found in the product is safe: “To put this in context – Citrus aurantium is Seville Orange – which is ingested regularly by millions throughout the world as marmalade. In an email (29 Jan 06) Dr Summers “drew Homemark’s attention two (sic) single case studies and to a review . . . which stated ‘although no adverse events have been associated with the ingestion of C aurantium thus far, synephrine . . . has the potential to increase cardiovascular events.’” [Comment A27] In comment A28 she adds “… Web searches in early 2008 did not reveal any updated information regarding the toxicity of C. aurantium” [My emphasis] 

Contrast her claims above with the following facts:

1.       As an expert in pharmacology, and considering that she subscribes to DrugInfo, it is unlikely that she had no knowledge of the cautionary statement regarding the toxicity of Citrus aurantium put out by the World Health Organisation pharmacy newsletter regarding Citrus aurantium (11/07/2007), and available on the web (and referred to documents I submitted to the ASA). Furthermore, in a Request for access to record of private body (Section 53(1) of the Promotion of Access to Information Act, 2000 (Act No. 2 of 2000) [Regulation 10] sent to both Homemark and Dr Summers, dated 25 April 2008, I referred to this newsletter: “Slim Coffee contains, among other, extracts of Guarana and Citrus aurantium. Health Canada received 21 domestic reports of adverse reactions suspected of being associated with Citrus aurantium (bitter orange). Of these, 15 reports were of cardiovascular adverse reactions, 10 of which were serious and included one report of myocardial infarction. According to Health Canada, synephrine, an alpha-adrenoceptor agonist found in bitter orange, can have serious adverse effects on heart rate and blood pressure; these effects are significantly potentiated by caffeine.”

2.       Dr Summers statement that “Citrus aurantium is Seville Orange – which is ingested regularly by millions throughout the world as marmalade” is misleading and disingenuous, and as an expert, she should be fully aware that Citrus aurantium used in these products are highly concentrated and are manufactured using dried extracts. Is this what one expects from a credible expert?

 

Synephrine Levels Bitter Orange Materials

Material

mg %

(mg/100 g)

Fresh fruit

270

0.020

Dried fruit

380

0.352

Dried extract

3000

3.003 – 3.079

Products

250-2500

0.250 – 0.989

Source: Pellati et al. 2002 

3.       Dr Summers states: “Web searches in early 2008 did not reveal any updated information regarding the toxicity of C. aurantium”. Yet a search of the most important medical scientific index, Pubmed, shows a number of studies that caution against this ingredient. In 2005, the American Journal of Medicine stated “Ephedra-free weight loss supplements have significant cardiovascular stimulant actions, similar to ephedra. These effects are not likely caused by C. aurantium alone, because an eightfold higher dose of synephrine (Advantra Z) had no effect on blood pressure, but may be attributable to caffeine and other stimulants in the multi-component formulation”, and this was in a study conducted in healthy individuals! [Haller CA, Benowitz NL, Jacob P 3rd. Hemodynamic effects of ephedra-free weight-loss supplements in humans. Am J Med. 2005 Sep;118(9):998-1003.] (SlimCoffee contained both)

4.       Dr Summers quotes in her defence and her expertise “although no adverse events have been associated with the ingestion of C aurantium thus far, synephrine . . . has the potential to increase cardiovascular events” [Comment A27] but takes this out of context and edited out two highly relevant sentences: “Although no adverse events have been associated with ingestion of C. aurantium products thus far, synephrine increases blood pressure in humans and other species, and has the potential to increase cardiovascular events” and “[T]here is little evidence that products containing C. aurantium are an effective aid to weight loss.” [My emphasis] And in 2001: “Individuals with severe hypertension, tachyarrhythmias, and narrow-angle glaucoma and monoamine oxidase inhibitor recipients should avoid SOJ consumption. Persons taking decongestant-containing cold preparations should also refrain from SOJ intake.” [Penzak SR, Jann MW, Cold JA, Hon YY, Desai HD, Gurley BJ. Seville (sour) orange juice: synephrine content and cardiovascular effects in normotensive adults. J Clin Pharmacol. 2001 Oct;41(10):1059-63.]

I argue that these are significant factors that a credible expert would have taken seriously, as was by Prof. Roy Jobson.

Subsequent to this product being referred to arbitration, Homemark quickly changed the formula arguing that they have become aware of its potential toxicity. However, Prof. Roy Jobson, the World Health Organisation, and even I was aware of this. Does Dr Summers suggest that either she did not know this fact, or does she argue that she warned Homemark but they did not pay attention. Certainly as a credible expert, I expect her to have not only known and to have warned relevant authorities.

And for a third Homemark product, SlimCoffee – Second formulation with Caralluma fimbriata, she again gave arguments in support of Homemarks’ claims for the product, yet in previous correspondence, she, as have other substantiators, indicated that the Natural Medicines Comprehensive Database (NMCD) (“Scientific Gold Standard for Evidence-Based, Clinical Information on Natural Medicines”) is a highly relevant and credible source for scientific evidence in support of substantiation. The NMCD states for this ingredient: “Effectiveness: INSUFFICIENT RELIABLE EVIDENCE to RATE. Weight loss. Preliminary evidence shows that taking a caralluma extract 500 mg twice daily for 60 days might decrease waist circumference, feelings of hunger, and fat and calorie intake. But it does not seem to decrease weight, body mass index (BMI), body fat, or hip circumference (15272). More evidence is needed to rate caralluma for this use.” Reference 15272 is the same as that referred to by Dr Summers: Kuriyan R, Raj T, Srinivas SK, et al. Effect of Caralluma Fimbriata extract on appetite, food intake and anthropometry in adult Indian men and women. Appetite 2007;48:338-44. 

Again it seems that Dr Beverley Summers opinion is contrary to international scientific standards, and considering that these products are being sold to scientifically naïve consumers, it would be critical for the “credible expert” to consider not only whether the science validates the claims, whether the science is adequate and robust, but also whether the final price to the consumer is commiserate with the health claims, and at around R1,600 for two months SlimCoffee supply, I simply cannot fathom how Dr Summers as a “credible expert” could have supported the claims for this product. 

 

C. Further critical points raised by Dr Summers in her appeal arguments:

I can understand that Dr Beverley Summers, in fighting for her “survival”, may make statements that are either devoid of truth, misrepresented, or out of context. I intended not addressing every issue she has raised for they may not be absolutely central to this appeal, but as she has raised these issues for the appeal, some particular statements do require a response in order to correct these misrepresentations.

1.       ASA interpretation of “could” or “does” for a product

I was informed during Ms Gail Schimmel’s tenure (and by Mr Leon Grobler), that the term “may” or “could” was not sufficient to substantiate a product and in these situations (as arose with Ms Vienings and her substantiation for Bioslim prior to this product), that the substantiator is contacted and the meaning clarified i.e., the substantiation “does” support the claims for the product.

2.       Complaint with the Pharmacy Council

Dr Summers writes: “I am given to understand that the complaint letter was received by the SAPC by June 2009. However, the SAPC has not, over 6 months later, seen fit to contact me to inform me that the letter has been received (which would be the first step in any disciplinary action). I do not believe that this reflects negatively on the SAPC, but rather, reflects positively on my track record as a committed pharmacist . . .“ [Letter dated 6th February 2010]

Contrary to Dr Summer’s claims, I have it on good authority (Ms Debbie Hoffman, Legal Services of the Pharmacy Council), that the complaint was forwarded to Dr Summers for comment some months before the end of 2009. I re-confirmed this telephonically with Ms Debbie Hoffman on the 10th March 2010, and where she affirmed that my complaint against Dr Summers had not been dismissed. (See accompanying letter) Ms Hoffman assured me that the Pharmacy Council is taking my charges against Dr Summers very seriously because of the gravity of the arguments. In my initial telephonic discussion with Ms Hoffman in 2009 made in order to request guidance in the process required for laying complaints with the Pharmacy Council, I verbally requested “for Dr Summers censure” and possible “de-registration as a pharmacist”.

3.       Dr Summer’s responsibility

Dr Summers writes “she is not involved with Homemark’s business decisions or product marketing choices”. Is she saying that she does not take cognisance of Homemark’s products claims and that her role in having the product with particular claims being accepted is not part of her ambit or responsibility? This is clearly argued in my submission to the Pharmacy Council. 

Conclusion

In conclusion, I argue that the previous ruling that stripped Dr Beverly Summers of her status as a “credible expert” was correct.

Sincerely,


Part B: The essential written argument against Dr Beverley Summers being re-instated

08 December 2009

Dear Makgato: 

Re: HOMEMARK SLIM COFFEE / H A STEINMAN / 12988 – Homemark’s appeal 

The Directorate’s decision to no longer accept Dr Beverley Summers as an independent credible expert for weight loss products and dietary supplements is a correct decision. The basis for the Directorate’s decision was the arbitration ruling in the Peel Away the Pounds case. 

Mr Wheeldon commences by stating that the Directorate’s finding that Dr Summers could no longer be accepted as an independent credible expert is “unprecedented”. This is not correct. Other “experts” have previously been rejected. For example: Dr Arien van der Merwe – a medical doctor – was initially accepted as a credible expert by the Advertising Standards Committee for purposes of substantiating a product; her status being revoked following the presentation of valid reasons by the complainant to have this status overturned. See: http://www.asasa.org.za/ResultDetail.aspx?Ruling=3504 

It must be noted that according to the Code of Advertising Practice’s Procedural Guide, Clause 16.2 arbitration is final and binding. Any consideration of the correctness or otherwise of the arbitration finding must therefore be beyond the scope or terms of reference of the appeal. 

It would furthermore be unacceptable to introduce Dr Summers’ substantiation of the new formulation of Slim Coffee into the appeal, as this would be tantamount to accepting that the Directorate had not made a correct decision before the appeal has even been decided. 

There is no dispute that Dr Summers has an impressive CV and professional record. This does not however trump her track record as far as substantiating advertising claims for weight loss products and dietary supplements. It is the latter with which we need to be concerned. 

There is also no dispute about her independence. 

An expert is someone widely recognized as a reliable source of technique or skill whose faculty for judging or deciding rightly, justly, or wisely is accorded authority and status by their peers or the public in a specific well-distinguished domain.[i] There are broadly two academic approaches to the understanding and study of expertise: that applicable to science understands expertise as an emergent property of communities of practice. In this view expertise is socially constructed; tools for thinking and scripts for action are jointly constructed within social groups enabling that group jointly to define and acquire expertise in some domain.1 Pharmacology and medicine have defined methodology and processes to ensure acceptable interpretation and implementation of findings from studies to the general population.[ii] 

In considering Dr Summers’ credibility and expertise, the focus must be on the process and methodology she used to reach her conclusions, rather than considering her conclusions per se, I intend to show that Dr Summers’ has repeatedly substantiated weight loss products and dietary supplements based on insufficient evidence and has also failed to adequately follow-up and assess important related information. 

The Code of Advertising Practice, Section I, Clause 4.25 defines “scientific substantiation” as: 

“Scientific substantiation” means substantiation based on statistically valid data, employing a validated, proven scientific method and applicable to the claim being made. 

Three components of scientific substantiation are clear from this. It must 

  • be based on scientifically valid data
  • employ a proven validated scientific method
  • be applicable to the claim(s) being made 

Clearly the substantiation of claims for weight loss products and dietary supplements can only be scientific and must therefore meet the Code’s criteria. Substantiation in this context is therefore not a matter of “opinion” – not even in the sense of “legal” opinion. 

Homemark is correct in stating that sometimes “experts” may not agree: this may occur in situations where the results are ambivalent but both points of view are arrived at by applying rigorous scientific principles in the review of the evidence – guidelines established and published. 

The Peel Away the Pounds arbitration clearly showed that in reaching her conclusions about the product’s advertising claims, Dr Summers had failed to accurately assess the study design, the statistical validity of the data, and the applicability of the study. Importantly and of relevance is the conclusion of the arbitration, that there was not simply a difference of opinion, but significantly that Dr Beverley Summers had not applied rigorous and vital scientific principles. The arbitrators state clearly and unequivocally:

“Any health claim should be substantiated by scientific based evidence. Three reputable institutions/organisations give the following criteria:

More than one randomized controlled trail (RCT) is needed because reproducibility is fundamental to progress in biological science (Aggett et a/.. 2005)

• According to the Position of the American Dietetic Association on Functional Foods “Foods that have a PDA-approved health claim generally are supported by 2 dozen or more well-designed published clinical studies” (ADA, 2004)

• The standard of scientific validity for a health claim includes two components: 1) that the totality of the publicly available evidence supports the substance/disease relationship that is the subject of the claim, and 2) that there is significant scientific agreement among qualified experts that the relationship is valid (FDA, 1999).” 

Dr Beverley Summers has failed to apply even minimal conditions for scientific based evidence in ALL the substantiations she produced for Homemark. 

For example, a pilot study is a small-scale methodological test intended to ensure that proposed methods and procedures will work in practice before being applied in a large, expensive investigation – conclusions of a pilot study cannot be applied to the public or groups in general, a critical fault (among other) of Dr Beverley Summers in her substantiation of Peel Away the Pounds. These failures are indicated in my line of reasoning below. 

The Directorate’s finding that a reasonable doubt had been raised was probably an understatement, but the decision to no longer accept Dr Summers as an expert was absolutely correct. 

The Directorate decided that Dr Summers’ substantiation for the revised Slim Coffee formulation could not be used and provided the following reasoning: “Given the inherent risks associated of (sic) potential exploitation of vulnerable consumers desperate to lose weight, the Directorate adopts a cautious approach. It cannot ignore the fact that Dr Summers’ evaluation of another similar weight loss product was regarded as incorrect by expert arbitrators.” (emphasis added) In my view this approach of placing risks to the consumer at the centre of the issue is both correct and responsible. 

From more than one substantiation submitted by Dr Summers in which she has accepted data that are not generalisable to large numbers of consumers, it would appear that Dr Summers is not particularly concerned about the end consumer. This however is one of two main purposes of the Advertising Standards Authority as stated in Clause 12 of the Preface to the COAP: 

The Code has two main purposes, namely, to protect the consumer, and to ensure professionalism among advertisers.” (emphasis added) 

Inadequate assessment of the safety of Citrus aurantium 

Of greater concern is that in the process of substantiating the original Slim Coffee formulation, Dr Summers failed to adequately investigate one of the main ingredients: Citrus aurantium. However, the Directorate accepted her substantiation for the product. Although arbitration was requested and the process of finding and identifying arbitrators was in process, the arbitration did not proceed because Homemark changed the formulation of Slim Coffee. 

I believe that in substantiating the original formulation of Slim Coffee, Dr Summers showed an unacceptable lack of expertise and credibility. 

The documentary evidence used by the ASA in making its decision (according to the ruling dated 8 April 2008) was a report written by Dr Beverley Summers dated March 22, 2006, submitted by Homemark as substantiation for a product she referred to as ‘Slim Coffee mix (also known as Silhouette Express “O”)’. Some additional information relating to the study’s ingredients and the packaging was provided in a letter from Dr Summers dated March 17, 2008 (nearly two years later!). 

In her substantiation dated March 22, 2006, Dr Summers seemingly ignored the warning issued in a World Health Organization Pharmaceutical Newsletter No 6, 2004, concerning serious adverse effects related to Citrus aurantium, as well as the additional warning that these adverse effects would be exacerbated by caffeine. Not only did the original formulation contain both Citrus aurantium and caffeine (as well as a caffeine-like substance – guarana), Dr Summers’ failure to adequately investigate the ingredients resulted in her stating that the product could be used “safely”. In her letter two years later, she again failed to comment on the WHO warning, even though it had been repeated in the WHO Pharmaceutical Newsletter No 3, 2007. She failed to comment on this warning even though I had brought this matter to her attention through my correspondence with the ASA. 

Furthermore, Homemark claims to have changed its Slim Coffee formulation almost a year later, arguing that the Medicines Control Council had taken a decision to schedule synephrine in April 2008. (Letter dated 3 February 2009 from Mr Hadjipaschalis to Mrs Omar) However the Schedules published on 5 September 2008 (Government Gazette 31387, Government Notice No 935) do not list synephrine  at all. In fact the Schedules do however, continue to list phenylephrine as they have done for many years prior to her substantiation of this product. Whether the decision to change the formulation because of “scheduling” decision or a concern for the safety of this ingredient, the fact is that this decision was made almost a year following Dr Summers substantiation which casts grave doubt on Dr Summers’ expertise or credibility. It is not clear who advised Homemark to change the formulation of Slim Coffee on the basis of a decision to Schedule synephrine, but if it was Dr Summers, her information was incorrect. 

Dr Summers mistakenly identified “guarana” as the active ingredient, and failed to recognise that bitter orange (Citrus aurantium) was the main active ingredient of the Slim Coffee formulation. Dr Summers furthermore failed to report that Citrus aurantium contains various isoforms of synephrine. One of the isoforms of synephrine is phenylephrine – which is a Scheduled substance according to the Medicines Act (and has been scheduled since at least 2003 when the Act was last amended.) 

This failure, on record, of Dr Summers’ inadequate assessment of the original Slim Coffee formulation could possibly have had detrimental effects on consumers. (It is fortunate for consumers that Homemark withdrew the product and changed the formulation even though Dr Summers had stated that the product should augment weight loss safely and effectively.) 

It is unfortunate that during the year following her 17 March 2008 letter and Mr Hadjipaschalis’s 3 February 2009 letter, Dr Summers did not withdraw her substantiation of the original Slim Coffee formulation considering a case report and a letter to the editor of the South African Medical Journal concerning the safety of synephrine. The case report in the May 2008 edition was of a 39 year old body builder using a mixture the included synephrine and similar compounds as well as caffeine. The young man experienced a non-fatal heart attack. The letter in the July 2008 edition was explicit in its heading: “Citrus aurantium – beware of the bitter orange” which describes a similar case of a British 28 year old man experiencing a myocardial infarct after exposure to synephrine. These articles are attached. 

An expert in weight loss products would have been well aware of the controversy surrounding Bitter orange / Citrus aurantium / synephrine. Dr Summers seems to have been quite unaware of the concerns about this substance and her credibility cannot but be considered questionable. 

Inadequate evidence that Slim Coffee mix and Silhouette Express “O” are the same 

Dr Summers failed to provide any documentary evidence that Slim Coffee mix was in fact the same as Silhouette Express “O” – she merely stated in her letter of March 17 2008, that the ingredients used in the study of Silhouette Express “O” were “consistent with” those contained in Slim Coffee. The more usual scientific evidence would be to provide certificates of analysis of each product showing that they were in fact the same. Basing one’s conclusions on a manufacturer’s packaging is not generally accepted as scientific validation. 

Ignoring the negative FTC conclusions about the study 

Dr Summers’ credibility and expertise must also be questioned in the context of the Federal Trade Commission (FTC) ruling against Slim Coffee. Dr Summers’ stated in her 17 March 2008 letter that “the product ruled against by the FTC in the USA which purportedly contains hoodia, is not the same product as that marketed by Homemark (Pty) Limited in South Africa.” 

This again reveals a lack of expertise for had Dr Summers adequately investigated the FTC complaint she would have found that the study was for the product not  containing hoodia and the ruling was against both hoodia and non-hoodia versions. The study rejected by the FTC was in fact the study for the product without hoodia, and appears, at face value, to have been the very study Dr Summers substantiated. Whether or not the study was the same, it would appear that Dr Summers did not adequately investigate, interpret or understand the full implications of the FTC ruling against the product. 

Similarly in the Peel Away the Pounds matter, it was clear to Dr Summers that the FTC expert panel decided unanimously that the study purporting to confirm the efficacy of this product was inadequate, not only for it being a pilot study, but for the fact that only ten women were evaluated of which only one lost weight, but resulting in an average loss for the group greater than the control group. It was also pointed out to Dr Summers that the manufacturers had settled out of court acquiescing that the study was inadequate to support the claims. An “expert” always evaluates new evidence brought to attention and interrogates the new evidence in the deliberations of the evaluation, neglected by Dr Summers. 

Although Homemark and Dr Summers claim that the Peel Away the Pounds ruling in the USA was not for the product as a whole system, this is in direct contradiction to the evidence: “Plaintiff FTC brings this action under Section 13(b) of the Federal Trade Commission Act (“FTC Act”), 15 U.S.C. § 53(b), to secure a permanent injunction, rescission of contracts and restitution, disgorgement of ill-gotten gains, and other equitable relief against the Defendants for engaging in deceptive acts or practices in connection with the advertising, marketing and sale of the Peel Away the Pounds System (“Peel Away”), a purported weight loss “system” including the Pound A Patch transdermal patch, in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52. “ “When consumers have ordered Peel Away, they have received a 30-day supply of Pound A Patch (10 patches, each to be worn for three days), a 21-serving canister of “Drink and Shrink” snack/meal replacement powder, an instruction booklet including the “Eat and Shrink” four-week meal planner, and the “Move and Shrink” low-impact exercise program and video.” This highlights her “expertise” and/or “credibility”. 

Failure to appreciate the extent of Good Clinical Practice (GCP) 

Dr Summers indicates in her letter of 22 March 2006 that the study appeared to have been conducted according to international Good Clinical Practice (GCP) guidelines. However, considerable efforts were made to verify the existence of the Italian research facility where the study was purportedly carried out. It was not possible to do this, and neither was the Italian Consulate based in Cape Town able to locate the research entity, the address of the entity supplied in Dr Summers’ substantiation, or even any record of its having previously existed. Dr Summers should have indicated, as part of GCP, that there appears to no longer be any record of the facility’s existence. At least Dr Summers should have commented on this discrepancy when brought to her attention, and re-confirmed her substantiation with proof that the entity did exist to counter my argument that the study was probably fabricated. 

The South African GCP requirements state unequivocally that appropriate study design is part of GCP. As will be shown, this was not the case in the Slim Coffee study, and this element of GCP was not adhered. Dr Summers appears to have a limited understanding of GCP – again making her expertise and credibility questionable. 

Failure to meet the COAP criteria for scientific substantiation 

The requirements of the COAP for scientific substantiation of the original Slim Coffee formulation, as with the Peel Away the Pounds substantiation, were not met. 

Dr Summers vouched for the validity of the study said to support the claims of Slim Coffee, without noting that:

1.       it is a single study (and therefore has insufficient data to make generalisations about or to substantiate a product)

2.       it has never been peer-reviewed (a universal requirement for studies)

3.       it has never been published (and can therefore not be publicly accessed and assessed)

4.       it was conducted by a seemingly non-accredited research centre of no well known standing, which no longer appears to exist (as indicated above)

5.       the study, (as described by Dr Summers), was a three month, three-arm study using 90 volunteers. Most significantly, she does not mention any comparison arm using “non-slim” coffee. (In other words the method was not a valid scientific method, and not of adequate power or duration to provide statistically or scientifically valid data)

6.       there is no evidence that the study was applicable to the product as the study was purportedly performed on a product called Silhouette Express “O”. 

All these factors must be taken in conjunction with Dr Summers’ failure to adequately and appropriately assess the Peel Away the Pounds product as well as her failure to adequately investigate the original Slim Coffee formulation. She in fact declared it safe when clearly she had failed to take the available evidence into consideration, and potentially put the public at risk. This alone should be sufficient evidence to confirm the Directorate’s decision to not accept Dr Summers as an expert for the purpose of substantiating weight loss products and dietary supplements. 

If the appeal committee decides to consider Dr Summers’ substantiation of the new formulation of Slim Coffee – which I believe it should not because the very appeal revolves around Dr Summers’ credibility and expertise – then I would wish to make the following statement. 

Applying the Code of Advertising Practice, Section I, Clause 4.25 definition of “scientific substantiation” as elaborated upon above, and considering the Directorate’s argument that “[G]iven the inherent risks associated of (sic) potential exploitation of vulnerable consumers desperate to lose weight, the Directorate adopts a cautious approach” to Dr Summer’s substantiation of the new Slim Coffee formulation, it is evident that she fails on both. Her substantiation does not make it absolutely clear to the ASA that the peer-reviewed published study does NOT confirm statistically significant weight loss for the new main ingredient in Slim Coffee, but uses the non-peer-reviewed study to suggest that the product will be effective. She furthermore does not meet the third criterion of the substantiation being applicable to the claims being made for the product because it is not the product as a whole that has been tested, but only a single ingredient. This approach has previously been found unacceptable by the ASA, and it is also not scientifically valid to substantiate a whole product’s claims without testing the whole product. 

Considering that it is recommended that users ingest 3 cups of Slim Coffee per day to obtain the equivalent dose of the active ingredient in the study substantiated by Dr Summers, this translates to consumers having to spend R1,600 over two months, surely indicative of exploitation of vulnerable consumers. I quote Bjorn Lomborg, who wrote: “… as scientists we are ethically bound to the scientific method, in effect promising to tell the truth, the whole truth, and nothing but – which means that we must include all the doubts, the caveats, the ifs, ands, and buts.”

Sincerely,

 


[i] http://en.wikipedia.org/wiki/Expert

[ii] Jüni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001 Jul 7;323(7303):42-6.

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  1. ASA ruling: Homemark Slim Coffee ruling | CAMcheck - 18 May, 2010

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