Posted 1 June 2010
The following formal complaint was laid with the South African Pharmacy Council against the ongoing actions of the pharmacist, Dr Beverley Summers for her continuing substantiation of products with no valid scientific proof of benefit, and at least two having been banned in the USA (and regarded as scams)
18 May 2009
The South African Pharmacy Council
PO Box 40040
Attention: Mrs Debbie Hoffmann
Dear Registrar/Mrs Hoffmann:
Re: Dr Beverley Summers – Request for Investigation into unprofessional conduct
I wish to lay a complaint with the South African Pharmacy Council against Dr Beverley Summers, a pharmacist, presumably registered with the Council, for what I believe to be irresponsible and unprofessional conduct. I believe that she has acted in this way by erroneously substantiating to the Advertising Standards Authority of South Africa (ASA), the efficacy of a number of “natural” products: Peel Away the Pounds, Slim Coffee (formulation Citrus aurantium) and Slim Coffee (formulation Caralluma fimbriata), on insufficient evidence, and in at least one instance has substantiated an unsafe product.
Peel Away the Pounds
A complaint was laid with the Advertising Standards Authority (ASA) on 23 November 2003 against the Homemark product, Peel Away the Pounds. The product, which included amongst others, a “kelp” skin patch, claimed to have efficacy in weight loss. Subsequent to my initial complaint to the ASA, I pointed out in numerous breaches of the ASA ruling, that a panel of 5 weight-loss experts of the USA FDA and Federal Trade Commission (FTC) found the substantiating evidence to support Peel Away the Pounds (which was exactly the same product being marketed and advertised in South Africa) inadequate, and consequently instituted a severe fine against Peel Away the Pounds for unsubstantiated claims, and banned the product from being sold in the USA: http://www.ftc.gov/opa/2004/03/peelaway.htm.
The manufacturers settled out of court admitting that the pilot study of ten individuals was insufficient support for the product. In spite of this fact and my argument that there was no evidence that kelp will be absorbed transdermally, Dr Summers “substantiated” the product in October 2005 claiming that there was sufficient evidence proving that the product as a whole had efficacy. Based on Dr Summers’ incorrect opinion, the ASA ruled in Homemark’s favour therefore allowing this unproven “scam” product to continue being sold to naïve consumers.
I appealed the ruling and argued that Dr Summers had erred, and that the study provided insufficient evidence. I supported my arguments with expert assessments from Dr Carl Lombard, Biostatistics at the Medical Research Council, Prof. Christine Venter, Department of Nutrition at the University of Potchefstroom, Prof Karen Charlton, previous head of the Department of Dietetics at the University of Cape Town and now attached to the MRC, and Dr Nelia Steyn, an expert on nutrition and the Chief Specialist Scientist, Chronic Diseases of Lifestyle Unit at the Medical Research Council who agreed with my arguments. In spite of this Dr Beverley Summers continued to insist that the product had proven benefit to consumers.
I subsequently requested arbitration, and an assessment by Drs Renee Blaauw and Edelweiss Wentzel-Viljoen concluded: “[T]he evidence, however, provided to substantiate the claims is based on one small pilot study (not a properly randomized control trial), which only evaluated the effect of the whole system on weight changes. The results are based on incorrect statistical methodology and incorrect interpretation of statistical calculations. The claims for increased metabolism and burning of fat are based on assumptions that iodine is absorbed from the patches, that the iodine is available to the body in sufficient amounts to increase metabolism which in turn will burn fat. No evidence was provided for either of these two claims. In conclusion, we do not agree with the ASA ruling of 27 October 2005 that “the system as a whole results in ‘weight loss; and that it ‘burns fat’ and ‘increases metabolism’.”
In other words, Dr Summers’ ability to adequately evaluate the evidence was refuted.
Homemark Slim Coffee
Homemark advertised Slim Coffee containing Citrus aurantium and making claims of efficacy in weight loss. I laid a complaint with the ASA on 23 January 2008 arguing that this product, claiming “Helps to Burn Fat”, “Suppress Appetite”, “Rapid results are scientifically proven” and to be a “Dietary Supplement” to either be misleading or unsubstantiated and therefore taking advantage of naïve consumers. The product also claimed “Drink Slim Coffee with every meal and your appetite is suppressed, your hunger pangs and cravings are curbed and your body is turned into a fat burning furnace”.
I pointed out that the FTC had acted against the manufacturers and marketers of this product. http://www.ftc.gov/opa/2008/01/dietcoffee.shtm . According to the FTC, the marketers “agreed to settle Federal Trade Commission charges that their advertising falsely claimed that their product would enable its users to lose significant amounts of weight without diet or exercise.”
I pointed out to the ASA that The FTC ruling stated, among other, “According to a complaint filed by the FTC in federal district court, the defendants’ weight-loss claims for Slim Coffee were false and unsupported by any reliable scientific studies, in violation of the FTC Act. Among other things, the Commission’s complaint alleged that neither Slim Coffee nor any of its individual ingredients, including hoodia, would enable its users to lose as much as two to five pounds per week . . . ” (Note: although the company markets two variants – one with Hoodia, and another without, it was the variant without hoodia that was marketed in South Africa. The FTC has acted against both variants.)
In the court documents, the ruling was not against Slim Coffee with Hoodia, but explicitly against Slim Coffee .
The court documents can be accessed as follows:
· Stipulated Final Judgment and Order for Permanent Injunction and other Equitable Relief as to Defendant Diet Coffee, Inc: http://www.ftc.gov/os/caselist/0723052/080104dietcoffeestipfinal.pdf
· Stipulated Final Judgment and Order for Permanent Injunction and Other Equitable Relief as to Defendant David Stocknoff: http://www.ftc.gov/os/caselist/0723052/080110dietcoffeestocknofforder.pdf
· Stipulated Final Judgment and Order for Permanent Injunction and other Equitable Relief as to Defendant David Attarian: http://www.ftc.gov/os/caselist/0723052/080104dietcoffeeattarianorder.pdf
· Complaint for Permanent Injunction and Other Equitable Relief (Including Exhibits A-K):http://www.ftc.gov/os/caselist/0723052/080104dietcoffeecmplt.pdf
I also pointed out at in a latter submission, that the product contains Guarana (Paullinia cupana) extract and Citrus aurantium extract but that the dosages are not indicated on the packaging.
In spite of the previous ruling questioning Dr Summers’ ability to adequately assess evidence, she substantiated this product as well.
Both Homemark and Dr Summers refused me access to the study, which had not been published nor peer reviewed. However, from Dr Summers’ documents I was able to glean some information and argued that:
1. There is no doubt that Dr Summers substantiation is flawed, simply because the substantiation submitted to and accepted by the ASA was a three month, three-arm study using 90 volunteers. There was no comparison group using “non-slim” coffee.
- That the study may not have been appropriately conducted for the name and address of the clinical research facility that “conducted” the research no longer existed, and the address provided was false. I was supported in checking this by the Italian consulate.
I requested arbitration. It was also pointed out to Dr Summers in a subsequent letter in support of my request for arbitration by Prof Roy Jobson, dated 5th May 2008, “[A]s a result of not reviewing the latest information available, which I would have expected from a credible expert, Dr Summers failed to point out that the World Health Organization (WHO) reported safety concerns about Citrus aurantium (in 2004 and again last year) in its Pharmaceutical Newsletters (No’s 2004, No 6 and 2007, No 3). Her written statement that the product should augment weight loss safely, is therefore, in light of this information, also questionable.” (emphasis added)
In spite of this, Dr Summers stuck to her position that the claims for the product could be substantiated and was safe.
Almost a year passed before an arbitrater was appointed, and upon being informed of this on 2nd February 2009, Homemark responded on the 4th February 2009 that they had changed the formulation and had removed Citrus aurantium having replaced it as explained by Homemark:
“As advised verbally towards the end of November 2008, we had already taken the decision to discontinue the Slim Coffee product in its current “disputed” formulation, back in June 2008, the last deliveries went into the marketplace in August 2008 and by now, there should be very few units left on the shelves in remote pharmacies and other retail chains…
Our reasons for discontinuing the product are as follows:
1 Back in April 2008, the Medicines Control Council took the decision to “schedule” an ingredient by the name of “Synephrine”. As soon as we became aware of this we sought advice from our consultants and manufacturers as to the status of Slim Coffee, because Citrus Aurantlum. the main active ingredient of Slim Coffee does contain “Synephrine”.
2. The advice was two-fold: First, to reinforce our warnings on the taking of Slim Coffee (which are stated on the external packaging and the enclosed leaflet) not only for people who are caffeine-sensitive, pregnant women and people with mild heart problems, but also for people with specific cardiovascular disease problems, hypertension, nervous system disorders etc. – Second, we were asked to seriously consider replacing Citrus Aurantium with another natural ingredient which can achieve the same results.
3 As a result, we implemented both recommendations even though we understand that Citrus Aurantium has not been scheduled by the MCC As from August/September last year, the “old” Slim Coffee formulation is no longer sold and instead, the new formulation is now sold.”
Dr Summers substantiated this new product around February 2008. So called “warnings” were placed, according to my information, around 6 months later. Did Dr Summers point out the seriousness of this or did Homemark ignore her advice? Furthermore, Homemark’s assertion that “synephrine” was only Scheduled in April 2008. This is blatantly untrue because as phenylephrine it was scheduled even prior to 2003 when the Medicines Act was amended. (Note: phenylephrine is another name for m-synephrine. It is surprising that Dr Summers’ did not point this out in her initial substantiation as would be expected of a responsible pharmacist acting in the interest of the public.)
Slim Coffee (formulation Caralluma fimbriata),
With the discontinuation of the earlier Slim Coffee formulation, the product was replaced by this version making the same claims as before.
I laid a complaint with the ASA and stated, among other:
Homemark claims they have proof of efficacy for this product. In fact, there is no study that has evaluated this new product which is a mixture of various ingredients. The dosage of the ingredients is not on the packaging. Homemark is suggesting that they are able to make the same claims as before based on the ingredient Caralluma fimbriata. In fact, only one study has ever been done utilising this ingredient. The findings of this study are significant. It found that, as summarized by Natural Medicines Complementary Database (NMCD): “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. NMCD, the “Scientific Gold Standard for Evidence-Based, Clinical Information on Natural Medicines”, used by numerous credible experts that the ASA has received substantiations from before, states” [M]ore evidence is needed to rate caralluma for this use.] In other words, one study is inadequate and requires independent reproduction to verify the findings. [My emphasis]
The abstract of the original study quoted in the NMCD’s summary, is posted below:
Appetite. 2007 May;48(3):338-44.
Effect of Caralluma fimbriata extract on appetite, food intake and anthropometry in adult Indian men and women.
Kuriyan R, Raj T, Srinivas SK, Vaz M, Rajendran R, Kurpad AV.
Division of Nutrition, Institute of Population Health and Clinical Research, St John’s National Academy of Health Sciences, Bangalore 560034, India. [email protected]
Caralluma fimbriata is an edible cactus, used by tribal Indians to suppress hunger and enhance endurance. The effect of Caralluma extract was assessed in overweight individuals by a placebo controlled randomized trial. Fifty adult men and women (25-60 years) with a body mass index (BMI) greater than 25 kg/m2 were randomly assigned into a placebo or experimental group; the latter received 1 g of Caralluma extract per day for 60 days. All subjects were given standard advice regarding a weight reducing diet and physical activity. At the end of 30 and 60 days of intervention, blood glucose and lipids, anthropometric measurements, dietary intake and assessment of appetite was performed. Waist circumference and hunger levels over the observation period showed a significant decline in the experimental group when compared to the placebo group. While there was a trend towards a greater decrease in body weight, body mass index, hip circumference, body fat and energy intake between assessment time points in the experimental group, these were not significantly different between experimental and placebo groups. Caralluma extract appears to suppress appetite, and reduce waist circumference when compared to placebo over a 2 month period. (emphasisi added)
Here are the relevant data from the study:
Table2: Anthropometric parameters of the subjects at baseline, day 30 and day 60 of the study
Note, there was no weight loss in users using Caralluma extract, the ONLY change was in the difference in waist reduction which was from 97 to 94 in the experimental vs 95 to 93 in the control group, i.e., 3cm vs 2 cm. Therefore in two months, only 1 cm of hip circumference loss can be expected, which may be statistically significant, but is clinically insignificant, and is not accompanied by weight loss.
It is therefore clear that Homemark cannot substantiate the claims being made for this product. Furthermore, and highly misleading, is the fact that Homemark does not indicate how much of this product has to be ingested daily. In the original study, even if weight-loss had occurred, a dose of 1g of Caralluma fimbriata was ingested per day to get a particular effect (in this instance no weight loss). That means that to conform to the study used , the user has to drink an equivalent amount added to the coffee. Would this be 5 cups, 10 cups, 20 cups or more? This is highly misleading to the consumer who would not know that drinking only 4 cups of Slim Coffee a day may not deliver the dose studied.
Furthermore, the consumer will be ingesting guarana as well. Guarana is a form of caffeine. As dried coffee will contain caffeine anyway, Homemark have now added more caffeine. This makes this product a high risk product with stimulant properties.
And of course, we don’t know what happens when you mix Caralluma fimbriata with coffee, caffeine or guarana! Maybe the effects (or side effects) are synergistic for one or more of the ingredients, or opposite. There is also no robust proof that guarana or caffeine will result in weight loss.
In spite of my having detailed the reasons for lack of proof of this product, Dr Summers was prepared to substantiate the claims for this product, stating that there was sufficient proof that this product was efficacious for weight loss, and other claims inter alia, “Energize, Nutritionally Enriched, Helps to Burn Fat and Suppress Appetite…”
I dispute Dr Summers conclusions about this and other products she has substantiated based on the limited scientific data to which I’ve had access, and I believe she has misinterpreted the information. The ASA have ruled that they will no longer accept Dr Summers as a credible expert for the substantiation of claims for weight loss products.
However, in the meantime Dr Summers has directly contributed to the continued marketing of unregistered products which made therapeutic claims without evidence of efficacy. This can surely be considered irresponsible and unprofessional behaviour that will have a direct influence on the public. It also does not comply with Good Pharmacy Practice (GPP) as gazetted and as published by the SA Pharmacy Council.
As the MCC is empowered only to regulate the availability and advertising of medicinal products, and has no standing in the issue of pharmacists’ professional conduct or GPP, I am directing my complaint to the Pharmacy Council. The MCC has by default relegated the issue of advertising to the ASA, which has no medical or scientific expertise of its own. The responsibility of pharmacists in their submissions to the ASA therefore becomes as important as the MCC’s own responsibilities in this regard. Pharmacists (and others) substantiating advertising of medicinal and health products are in effect standing “in loco” for the MCC, and the public must surely be able to expect responsible, ethical and professional conduct of pharmacists who choose to participate in such an exercise.
In the Government Gazette of 17 December, 2004, number 27112, the SA Pharmacy Council published the Board Notice 129 of 2004, titled Rules Relating to Good Pharmacy Practice, issued in terms of section 35A(b)(ii) of the Pharmacy Act 53 of 1974, as amended.
The third edition of these rules has been published on the Pharmacy Council website at http://www.pharmcouncil.co.za/documents/GPP%202008.pdf.
In the Introduction to this document, the following statement is made: “The vision of the South African Pharmacy Council (“Council”), in serving the public interest and in terms of its statutory obligation, is to ensure that pharmaceutical services are the best to meet the health care needs of the people.
“The vital element in this vision is the commitment of the pharmacy profession to promote excellence in practice for the benefit of those they serve. The public and other professions will judge the pharmacy profession on how that commitment is translated into the practice they observe.” (p1/233)
Although I am not a pharmacist, I would consider the substantiating of advertising claims as falling within the broad ambit of a pharmaceutical service – particularly as the primary basis for the ASA accepting Dr Summers was on her background in pharmacy. I therefore submit that Dr Summers is subject to GPP in substantiating advertising claims of pharmaceutical products.
I would further submit that because the “Scope of Practice of Pharmacists” section of GPP, subsection iii of section a, states that: “[the] furnishing of information and advice to any person with regard to the use of medicine;” (p3/233) this information and advice would logically also include advertising claims for medicines and any act that would lead to these advertising claims being made.
The section “Good Pharmacy Practice Requirements” indicates under section f subsection ix that “good pharmacy practice as published in rules by Council must be adhered to by all pharmacists practising in South Africa;” (p5/233) and that this would include Dr Summers.
This is followed by a statement indicating that “(b) Professional standards for services” is addressed as an element of GPP in the document (p5/233) and the substantiation of advertising claims by a pharmacist, as a service, would therefore form an element of GPP.
On p7/233 under the heading “General Objectives and Requirements of Pharmaceutical Services” section h states: “medicine information must be provided to promote the safe, effective and economic use of medicines by active and passive provision of accurate information and advice to all members of the health care professions and the public.” (emphasis in original) I submit that by erroneously substantiating advertising claims for medicines, Dr Summers failed to provide accurate information advice to members of the public (and health care professions) in order to promote safe, effective and economic use of medicines, but that by substantiating false and misleading advertising claims, she was providing misinformation about the safe, effective and economic use of medicines. She would appear to have contravened this GPP rule.
Chapter 2, Section 2.8, “Minimum Standards for Patient Information and Advice”, Subsection 2.8.2 “General Considerations” part d states: “Pharmacists must assess and, where appropriate, comment on promotional materials for medicines and other products associated with health.” (p73/233) This statement very specifically places marketing and advertising of medicines and other products firmly in the pharmacists’ arena. I would submit that by erroneously substantiating the products outlined above, Dr Summers has contravened this GPP rule.
Section 2.22 is headed: “Minimum Standards for the Provision of Complementary Medicine” and there is a subheading “Guidance” which reads: “Information about complementary medicine must be suitable for the needs of specific groups of clients and must not make claims which in the pharmacist’s judgement, are misleading or speculative.” (p160/233) Dr Summers judgement concerning the information about the complementary medicines she substantiated the advertising claims for was erroneous and the information in the advertising claims was misleading. She would appear to have contravened this GPP rule.
The GPP rules frequently and repeatedly state that in the provision of any service a pharmacist must “always act in the best interest of the patient”. I believe it is not in the best interest of any patient for a pharmacist to erroneously substantiate advertising claims which as a result may lead to misleading advertising and consequently possible adverse effects (including financial) for the patient. I would submit that by erroneously substantiating the advertising claims of certain products, Dr Summers has contravened this most fundamental of all GPP rules.
In addition to the above apparent contraventions of GPP, the Pharmacy Council Website (www.pharmcouncil.co.za) has a webpage under the heading of “ethics”. This has a subheading: “Rules Relating To Acts Or Omissions In Respect Of Which The Council May Take Disciplinary Steps” and is dated January 1992. I accessed the webpage on 16 April, 2009.
Rules 22 and 23 state:
22. The performance by a pharmacist of professional acts for which he (sic) is inadequately trained or insufficiently experienced.
23. The sale or promotion of the sale of medicine in any manner which has its aim or may be interpreted or regarded as having as its aim, the promotion of the misuse or abuse or detrimental or injudicious or unsafe use of medicine.
I believe, based on the several possible contraventions of GPP indicated above and the ruling of the ASA (Annexure I), that Dr Summers is inadequately trained and insufficiently experienced to rigorously and scientifically substantiate the advertising claims for these products, thus contravening rule 22.
I believe that the effect of her substantiating the efficacy of Slim Coffee (the others are no longer available) could be to promote the sale of a medicine which may be interpreted as having as the aim of its promotion, the injudicious and/or unsafe use of this medicine.
I would like to respectfully point out to Council that, in the context of Rule 23, this product meets the definition of a medicine in terms of the Medicines and Related Substances Act (Act 101 of 1965), and that, because of the therapeutic claims made, it cannot be considered a so-called “dietary supplement”. I would refer you to the High Court judgment of 2008, concerning Dr Rath in this respect. I would also like to point out that, to the best of my knowledge, there is at present no legal definition of “dietary supplement” in South African law.
I am also informed that as a general principle, a pharmacist would not substantiate a product if evidence of the quality of the product was not available. It is unknown whether or not Ms Summers had access to an independently obtained certificate of analysis for the finished product. This is not mentioned in the ASA ruling.
In addition, I would not expect a pharmacist to substantiate claims for efficacy in the absence of evidence of safety and an acceptable benefits-harms profile of the product. There’s no evidence in the ASA ruling that Dr Summers considered safety of Citrus aurantium in Slim Coffee. Safety issues have however been reported with Citrus aurantium by the WHO.
From my point of view as a health professional, albeit not a pharmacist, these all constitute unprofessional conduct and I would respectfully request that the Pharmacy Council investigate and take the necessary action.
I would furthermore respectfully request that when the GPP rules are revised, that the issues of marketing and advertising of products, and their substantiation be made explicit. I have had to rely on a general interpretation of GPP in pointing out, what I perceive to be, contraventions of GPP by Dr Summers.
I look forward to hearing from you.
The results of the complaint can be read here: “South African Pharmacy Council absolves substantiators“