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Product: Health & Beauty (Alternative Therapies)
Advertiser: Patricia Daly
ASAI Code 7th Edition: 2.4(c), 4.1, 4.4, 4.9, 4.10, 11.5
The following are extracts from websites www.patriciadaly.com and www.ketoforyou.com
Web Page A – www.ketoforyou.com
Give Cancer Cells A Tough Time By Removing Their Favourite Food From Your Menu!
Start Learning Now!
EXCLUSIVE TRAINING With Ketogenic Diet Specialist
My Proven Keto Formula:
A Blueprint to Implement a Ketogenic
Diet for Cancer with your Patients.
Join me now and explore the opportunity to add an invaluable tool to your practice!
The ketogenic diet is gaining a lot of traction in the medical world and now is the time to learn about it if you don’t want to miss the boat! Add another string to your bow – i.e. another tool to your practice – and make a real difference to the life of cancer patients and other patients with chronic degenerative disease. Achieving ketosis has been shown to not only enhance your patient’s response to conventional cancer treatment but also have an effect on tumour markers, immune health, mental wellbeing and, most importantly, quality of life. Join me now to learn more!”
Web Page B – www.ketoforyou.com
“EXCLUSIVE TRAINING With Ketogenic Diet Specialist
How To Stop Feeling Overwhelmed By The Ketogenic Diet For Cancer: The 5 Secrets To Make It Work For You!
A Game Changer for Cancer Patients
Achieving ketosis has been shown to not only enhance your response to conventional cancer treatment in pre-trial studies. A ketogenic diet may also have beneficial effect on your tumour markers…”
PAY IN FULL 497.00 USD
Safe, practical and evidence-informed nutritional support for cancer patients can enhance the effectiveness of medical treatments, improve quality of life and help reduce treatment side effects. It has been proven that nutritional intake can impact outcomes and in most cancers also affect the risk of progression and recurrence.”
Web Page C – www.ketoforyou.com
“Used as a success treatment against epilepsy since the 1920’s, the Ketogenic Diet restricts all but non-starchy vegetable carbohydrates and replaces them with low to moderate amounts of protein and high amounts of healthy fats.
The strength of the diet is metabolics. Cancer cells need glucose to thrive and carbohydrates turn into glucose in your body; lowering the glucose level in your blood through a low carb and protein diet serves to literally starve the cancer cells to death. Eating this way will help you convert your body from carb burning mode to fat burning mode.”
Web Page D – www.ketoforyou.com
“Patricia Daly’s Approach is Unique
She’s not only talking the talk as a practitioner and educator but has also been walking the keto for cancer walk over 4 years herself. Her ability to take on board the most recent science and turn it into safe and approachable practice is what makes her stand out from the (nutritional) crowd.
YOUR INVESTMENT: 455 USD PER MONTH (OR 1,226 USD BY PAYING FOR 3 MONTHS IN ADVANCE)
As a fully qualified and experienced nutritional therapist who specialises in cancer nutrition and the ketogenic diet in particular, I’ve supported hundreds of cancer patients on their journey. You can learn how to support yourself through treatments with a ketogenic diet and also in the recovery process.”
Web Page E – www.patriciadaly.com
“I have a problem, for instance, when health practitioners or doctors state that they didn’t take a specific therapy into consideration because they’re waiting for the randomized placebo-controlled trials to advise clients. This is the case with the ketogenic diet for cancer patients, for instance. There were various reasons why I feel uncomfortable with this 100% evidence-based approach and why, 3 years ago, I decided to start guiding cancer patients through the process of implementing the ketogenic diet although large human clinical trials weren’t – and still aren’t – available:
• My priority when I work with clients is “First do not harm” (have a look here for a fab movie). When an intervention – in my case the ketogenic diet – had a track record for safety, I don’t see any reason why I should wait for the results of the rigorous clinical trials, which probably could take years to come in.
• This brings me to the next point. Many chronically ill people and cancer patients in particular don’t have the luxury of time. Many people who contact me were in advanced stages of cancer and waiting for a few months or even years to have “solid evidence” might be too much.”
The complainants, the Irish Nutrition and Dietetic Institute (INDI), said their complaint related to the contents of websites (www.patriciadaly.com and www.ketoforyou.com) run by the advertiser. They considered that claims contained in the websites were matters which gave rise to public safety concerns.
The complainants advised that the advertiser’s websites contained a number of claims regarding the use of the ketogenic diet as a therapy for cancer. They considered that the claims/representations made on the websites were unsubstantiated and/or misleading and/or made by a person who was not suitably qualified.
Website contents, according to the complaint, related to the Ketogenic Diet and which, while not an evidence based treatment for cancer, was a proven medical therapy/treatment for patients with a particular type of intractable epilepsy which did not respond to medication. Being a very low carbohydrate/high fat diet, it needed to be closely monitored by a dietitian as part of a medical team.
By way of further background, the complainants provided information on the ketogenic diet by two senior dietitians in Ireland, one with expertise in ketogenic diet therapies and the other in radiation oncology, and both members of INDI. The information included content which stated that the ketogenic diet was a very high fat, low carbohydrate diet with adequate amounts of protein. The aim of the diet was to produce ketone bodies, which were normally only produced by the body in energy restriction. The diet was very restrictive, as in many situations a maximum of 20g carbohydrate was permitted per day (e.g. 1 Potato= 10-15g carbohydrate). Most of the energy came from the fat in the diet with the main sources being butters, oils, and creams together with protein foods such as eggs, meat, fish and cheese, weighed each day. The ketogenic diet was one of the most challenging and restrictive medical diets, and they said it must be administered and monitored under appropriate supervision to ensure safety and efficacy of the diet therapy, and to allow for medication and diet alteration as required.
For epilepsy treatment, blood ketone and blood sugar levels were monitored daily to assess levels of ketosis and guide any required alteration to the diet that may improve seizure activity if required. This also ensured that ketone levels did not increase to an unsafe level and make the person feel ill or become very medically unwell. There was also the risk that blood sugar levels may be too low which could also have severe side effects. The diet was not suitable for all patients, and a screening process was undertaken for all referrals. They explained, for example that if a person was very underweight, the diet should not be initiated until they were more stable.
The information provided also stated that in the last number of years there had been growing interest and research on the use of ketogenic diet in other neurological disorders but much of the research to date had been based on animal studies. There were also some animal studies outlining the potential for the ketogenic diet to be used as a therapy option alongside conventional treatments of radiotherapy and chemotherapy in some brain tumours especially where there were tumour associated seizures or slow growing brain tumours. However, this was only suggested at present with a small number of individual human case reports and animal studies. Clinical trials, which would influence medical practice, were required to determine if ketogenic diet therapy was an effective and safe therapy option in neuro-oncology.
Research had consistently shown that weight loss during cancer treatment could adversely affect outcome, treatment tolerance, recovery from surgery and could also have a negative impact on quality of life and overall survival. The complainants said that one of the most challenging elements of an oncology dietitian's job was managing patient weight loss during treatment. Different cancers could have different effects on dietary intake and nutritional status, and this should be assessed and managed by a qualified registered dietitian, working in conjunction with an oncologist.
Finally, the information provided by the dietitians stated that the ketogenic diet was not currently recommended by oncologists or dietitians in Ireland for people with cancer.
INDI also submitted comments from the Irish Cancer Society (ICS) who stated that they were supporting the complaint being made. Regarding material contained on the advertiser’s websites referred to above, the ICS highlighted their concerns arising out of what they considered were patients and the general public being exposed to misinformation and misrepresentation pertaining to the efficacy of a ketogenic diet in the prevention and management of many life threatening medical conditions, especially cancer.
The ICS stated that a handful of very early stage clinical trials were underway to examine the utility of a medically defined keto diet on a few cancer types. To date, none of these studies had provided accepted medical evidence as to the anti-cancer efficacy of a ketogenic diet. A randomised phase 3 study was the accepted gold standard for any cancer diagnostic or therapy and no one had conducted a study capable of demonstrating any efficacy for a ketogenic diet.
The ICS stated that a dietitian was the only statutorily recognised profession for giving diet-related advice and guidance to people who have an illness. They stated that the nutritionist qualification referred to by the advertiser was neither recognised, accredited nor originating from any higher education institution (university or college) in Ireland and hence was not subject to any of the accepted oversight processes accepted for professional degrees and diplomas.
The advertiser stated that the complaint was without foundation as it dismissed on-going and developing research into the ketogenic diet, and its potential value in terms of its use alongside or as an adjunct to conventional treatment by cancer patients. She stated that the services provided by her website did not breach any aspect of the ASAI Code.
The advertiser stated that the services offered by her online sites, and all of the research into the ketogenic diet were presented in an informed and transparent manner and seek to ensure that, as a priority, users of her websites were fully informed about the diet; both as to its attributes and potential value in a very clear context. She stated that when both websites were viewed in their entirety, this becomes abundantly clear and that she was aware and conscious that those availing of her services were individuals who were unwell and utmost care was taken by her in that context.
The advertiser stated that a view could not be taken by selective extracts of her websites, as a misleading impression was given, and naturally the content was interpreted in a particular manner and context by the complainants. She noted that the extracts referred to in the complaint were a fraction of what was on the websites, and she asked that consideration be given to the nature of the information given, the research and scientific references, and the manner in which some care was taken to ensure that vulnerable people did not believe that the ketogenic diet was some sort of cure for cancer, or some form of treatment of itself that will rid them of their cancer. She stated that no claims of this nature were made by her and that this was untrue. She stated that the content material on her website as a whole and taken in context did not have the effect, or the probable effect, of misleading or misinforming a reader in any way.
She stated that every scientific view and area of research could be countered by another; what of course was vital was that those supporting a particular view did not make misleading claims to vulnerable people.
The advertiser stated that significant research had been done outside of Ireland on the ketogenic diet and that eighty percent of those people availing of her online services were located outside of Ireland, with her websites aimed at an audience located outside of Ireland, hence the domains “.com”. She stated that some very significant research had been done on the benefits of the ketogenic diet in jurisdictions outside Ireland.
In relation to what the ketogenic diet was, the advertiser stated that there was plenty of pre-clinical data (not only in animals) showing that cancer growth was tightly linked to insulin signaling, IGF-1 and many of the other energetic pathways linked to insulin signalling. She stated that the ketogenic diet had been used for almost a century in epileptic patients and the significant advantage arising compared to other dietary and medical interventions was that safety studies (phase 1 clinical trials) have been done in children suffering from epilepsy. There was other compelling data suggesting that carbohydrate restriction could offer significant benefits for cancer patients.
The advertiser stated that she did not make claims, but rather report the findings of expert registered dietitians, medical doctors, oncologists and professors researching the ketogenic diet as an adjuvant therapy. She stated that the ketogenic diet was a very promising area of cancer research.
The advertiser stated that the ketogenic diet had been proven in RCTs (randomized controlled trials- the gold standard in medicine) to not only be an effective, but most importantly, a safe option to treat children with certain types of epilepsy for decades. Given this safety record, investigating the potential the ketogenic diet had for other chronic illnesses made a lot of sense to open-minded doctors and scientists around the world. The advertiser provided a list of eight experts, six of whom were identified as based in the USA, and five medical professionals based in the UK who she stated were showing an active interest and/or were working with the ketogenic diet as an adjuvant to conventional treatment for cancer. The advertiser also provided website links to current ongoing clinical trials on the ketogenic diet for cancer and a link to how internationally interest into researching the ketogenic diet for cancer was rapidly growing.
The advertiser stated that, contrary to the complaint, she never used the words “treat” or “treatment”, “cure”, “heal” or “alternative” for ketogenic diet and cancer. She stated that as a fully qualified Nutritional Therapist, it was her job to support and help patients manage their illness in relation to diet (amongst other factors such as stress, lifestyle & exercise), especially dealing with side effects of treatment and to improve their quality of life in a safe way. She stated that it was crystal clear on her website that research into the ketogenic diet was in pre-clinical stage, for instance the “FAQ” section under the service descriptions.
The advertiser stated, regarding the suggestion of no results from clinical trials on humans, that there was abundant evidence that this dietary approach was safe and did not put patients in danger, especially when they were monitored by a medical professional.
Addressing the complaint that weight loss could put patients in danger, the advertiser stated that the evidence here was conflicting, especially because there was no clearly established definition of cachexia (the rapid muscle and weight loss that could occur in some cancer patients). A nutrition protocol/drug that had shown clear benefits for cachectic patients currently did not exist and research was ongoing. Very recent studies in humans and animals showed that carbohydrate restriction could be a promising strategy for patients suffering with cachexia. She stated that, again, this topic was subject to ongoing scientific debate, like many others in the area of cancer research.
The advertiser stated that there was lots of data (e.g. laboratory data, biochemical pathways, cohorts) demonstrating that a ketogenic diet as a dietary strategy for cancer patients had significant potential. She outlined that data showed that high glucose reduces p53, a tumour-suppressor gene that protects us from cancer. She stated that this was also an important tumour marker, referencing that comment by the complainant that the ketogenic diet cannot affect tumour markers. Another tumour marker that had been shown to be modulated by the ketogenic diet was TKTL1. Hyperglycaemia was a state of chronically elevated blood sugar levels. If this was the case in a cancer patient, a poorer prognosis could be expected, she stated. There was also research that shows that the higher the blood sugar levels were, the more tumour growth was experienced.
The advertiser stated that she had never claimed or proposed that the ketogenic diet was a universally accepted approach to diet for cancer patients. She stated that it was clear that there was no consensus on both the ketogenic diet and its value in the medical profession at this point in time.
Regarding qualifications, the advertiser stipulated these as dipNT (Nutritional Therapy), mNTOI, Mbant. She stated that she was regulated in the UK (mBANT, rCNHC) as there was no suitable regulatory body for Nutritional Therapists in Ireland.
The Executive requested the advertiser to identify specific documentary content submitted which was relevant to grounding, supporting and evidencing her responses to the complaint. She was also asked to provide further and more detailed information and evidence regarding her qualifications.
The advertiser stated that she could provide further references to her conference presentation and her papers. She stated that, in her earlier submissions, she had quoted and provided references which included a list of UK, US and other medical experts who were working with the ketogenic diet in terms of its value as a nutritional approach to be used alongside conventional treatments for cancer.
She stated that the complainant did not have to agree with the use of this diet, and it was acknowledged by her that support for this diet predominantly came from the US and the UK and not Ireland.
Regarding the complainants’ claim that her websites were misleading, she stated that it was unconscionable that she would mislead vulnerable people. She stated that the website included the statement: “I don’t recommend doing the ketogenic diet as a standalone treatment”. She stated that she encouraged consumers to use the diet under supervision. She added that it was clear on her websites that the value of the ketogenic diet was not accepted by everyone, and that was why she gave careful and clear guidelines about its use and value within a very clear context.
Regarding qualifications, the advertiser responded advising that she was qualified to provide nutritional advice as she met the UK National Occupational Standards in the practice of Nutritional Therapy. Nutritional therapists were regulated by the CNHC (Complementary and Natural Healthcare Council), which was accredited by the Professional Standards Authority for Health and Social Care (PSA). The PSA was the independent government-appointed body that oversees and scrutinises the work of the nine statutory medical, health and care regulators, as well as accredits the registers of health and care occupations that were not regulated by law. Also, the General Medical Council (GMC) in the UK had endorsed use of professionals on CNHC register. She stated that, in short, as a nutritional therapist registered with BANT (British Association for Applied Nutrition and Nutritional Therapy), she was qualified and insured to deal with patients.
The Executive reverted to the advertiser seeking specifics for substantiating evidence regarding the complaint.
The advertiser stated that she had provided ample evidence to demonstrate that she did not make misleading and unsubstantiated claims. She referenced that INDI and ICS have expressed views at odds with hers due to their differing approach to nutrition in the context of cancer support. She stated that there were two conflicting views on a very complicated debate going on worldwide.
The advertiser stated that she had provided full and comprehensive details of her qualifications and provided a link to www.bant.org.uk(1) . She stated that nowhere in her resources was conventional treatment discouraged and references were repeatedly made for patients to seek medical supervision by health care professionals. She stated that she made it more than clear that she was a complementary and integrative rather than an alternative practitioner. She stated that wording that appeared clearly on her websites, as follows:
“NOTICE: The information contained or presented on this website is for educational purposes only. Information on this site is NOT intended to serve as a substitute for diagnosis, treatment, or advice from a qualified, licensed medical professional. The facts presented are offered as information only – not medical advice- and in no way should anyone infer that we or anyone appearing in any content on this website are practising medicine. Any diet, health, or nutritional program you undertake should be discussed with your doctor or other licensed medical professional. Seek the advice of a medical professional for proper application of ANY material on this site to your specific situation”
On 30th March 2017, the Executive observed that there were partial changes to the content of web pages A, B and D and the content of Pages C and E were the same as at the time the complaint was submitted.
The Complaints Committee considered the detail of the complaint and the advertisers’ response.
The Committee noted the volume of material presented by the advertiser, the apparent different approaches to the uses and effectiveness of the diet and the general acceptance that the diet is the subject of ongoing research regarding cancer treatment.
Webpages A to E
The Complaints Committee considered that while disclaiming information was referenced on the website, the webpages concerned did not contain any qualifying statements or links to other pages on the website to explain potential limitations of the diet associated with cancer treatment. Noting that the duty rested with the advertiser to show compliance of an advertisement with the Code, they were concerned by the absence of appropriate levels of authoritative, recognised and compelling research on human clinical trials. In addition, the advertiser, while providing a range of information, had not, as requested, demonstrated how the material submitted supported the advertising claims made.
Taking all the aforementioned factors into account, and notwithstanding the diet being promoted as an adjunct to cancer medical treatment, the Committee were of the view that the content concerned was likely to mislead consumers, and vulnerable cancer patients in particular, regarding the efficacy of the diet as claimed. In the circumstances, the Committee considered the advertising was in breach of Sections 4.1, 4.4, 4.9 and 4.10 of the Code.
The Complaints Committee noted the advertiser’s diploma qualification, professional membership and associations with UK based entities. While they also noted the advertiser’s position that there was no suitable nutritional therapy regulatory body in Ireland, nevertheless the advertisement was published in the Irish jurisdiction.
The Committee noted that, under the Code, advertisers should not discourage essential treatment for conditions for which medical supervision should be sought i.e. they should not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified health professional. For the purposes of the Code, health professionals were considered suitably qualified if they were regulated by a statutory body recognised by the Irish State. In this case, the Committee did not consider that evidence had been provided to demonstrate that the advertiser’s qualifications were regulated by a statutory body recognised by the Irish State.
The provision of advice and/or treatment on the advertiser’s website relating to the ketogenic Diet and cancer were therefore in breach of section 11.5.
The Complaints Committee told the advertiser not to refer to efficacy of the ketogenic diet in relation to cancer treatment until they held appropriate evidence to substantiate the claim. In addition, without holding an appropriate qualification, claims in relation to advice and/or treatment for serious conditions should not be made.