Ad description

A website for Dr P E Idahosa, www.mobilepsychiatricclinic.co.uk, included a web page headed “Chelation therapy throughout the UK”. Further text stated “Following its initial use in the 1950s by the US navy, when they used EDTA to treat lead poisoning in personnel, chelation therapy quickly gained ground as a treatment for cleansing arteries in people with cardiovascular disease. Chelation lowers serum ionized calcium, which decreases clotting, reduces spasms and softens arterial hardening. Chelation can be administered intravenously, orally or rectally. There are usually 1-4 treatment sessions a week for several months, with up to 30 sessions to achieve the maximum effect. As the chelation process can overload the kidneys, renal function must be monitored. Patients should take regular exercise and eat a healthy, balanced diet. With chelation therapy, patients should experience an increase in blood circulation, increased energy levels, enhanced memory and normalised blood pressure. Lost bodily functions may be restored and levels of pain reduced. HDL cholesterol is increased, whilst LDL cholesterol decreases. Chelation treatment has been successfully used to treat: Cardiovascular disease, Cognitive decline, Diabetes Mellitus, Intermittent claudication, Macular degeneration, Plaque build-ups caused by calcium, Arthritis, Hypertension, Scleroderma, Psoriasis, Parkinson's disease, Neurological conditions, Chronic Fatigue Syndrome … Chelation therapy should not be seen as a remedy for acute problems, but as a great cleanser, or detoxifier, of the human body. The possible adverse effects on kidney function are real and must be taken seriously”.

Issue

Stephen Barrett, M.D., operator of quackwatch.org, challenged the chelation therapy claims of “… increase in blood circulation, increased energy levels, enhanced memory and normalised blood pressure. Lost bodily functions may be restored and levels of pain reduced. HDL cholesterol is increased, whilst LDL cholesterol decreases” and that it could treat the listed conditions could be substantiated.

Response

Dr P E Idahosa said he was a physician trained in internal medicine and cardiology as well as public health and natural healing. He said that chelation therapy had begun as a treatment for lead poisoning, but had become the choice of physicians in the treatment of cardiovascular conditions, notably angina and peripheral vascular disease, and that it was superior to coronary artery bypass surgery. He said that chelation therapy removed most of the toxic metals in the body, such as lead, mercury, arsenic and aluminium, which had the effect of increasing the volume of blood flowing through the body. He said that as a consequence of this increased blood flow more oxygen and nutrients were carried to tissues in the body, leading to increased energy levels, enhanced memory and reduced or normalised blood pressure as the arteries became more flexible and dilated. He said that chelation therapy benefited people with erectile dysfunction, diabetes, diabetic retinopathy, macular degeneration, Parkinson’s disease and memory problems. He provided evidence which he said supported the claims in the ad. He said that some documents related to a ten-year study of chelation therapy and accompanying assessments and opinions. He also provided information from websites listing the benefits of chelation therapy and information regarding clinical research studies into chelation therapy. He said all studies into the therapy had been positive. He said that some of the documents he had provided were handwritten because he had been unable to print them out.

Assessment

Upheld

The ad stated that chelation therapy could "experience an increase in blood circulation, increased energy levels, enhanced memory and normalised blood pressure. Lost bodily functions may be restored and levels of pain reduced. HDL cholesterol is increased, whilst LDL cholesterol decreases" and that "Chelation treatment has been successfully used to treat: Cardiovascular disease, Cognitive decline, Diabetes Mellitus, Intermittent claudication, Macular degeneration, Plaque build-ups caused by calcium, Arthritis, Hypertension, Scleroderma, Psoriasis, Parkinson's disease, Neurological conditions, Chronic Fatigue Syndrome". We therefore considered whether the evidence that had been provided substantiated those claims.

Dr Idahosa had provided a 2013 clinical trial, published in an American peer reviewed medical journal, which had examined the effects of chelation therapy on cardiovascular events in patients with previous myocardial infarction (MI). We therefore considered the study was relevant to the claim in the ad that chelation therapy had been successfully used to treat cardiovascular disease. The trial was double-blinded, randomised and placebo controlled and was conducted on 1708 patients aged 50 years or older who had experienced an MI at least six weeks previously; 289 patients withdrew during the trial. The trial was conducted from September 2003 to October 2011. The primary end point measured was a composite end point of total mortality, recurrent MI, stroke, coronary revascularisation or hospitalisation for angina. We considered that the trial methodology appeared to be robust, and noted that it had been published in a reputable American medical journal. The primary end point occurred in 26% of the chelation group and 30% of the placebo group, and the difference was statistically significant, although there was no statistically significant difference in mortality between the two groups. The authors concluded that among stable patients with a history of MI, compared to placebo, the use of chelation therapy modestly reduced the risk of adverse cardiovascular outcomes, in particular revascularisation procedures. They said that patients with diabetes and with anterior MI had particularly benefited from the treatment.. However, they said that the results provided evidence to guide further research, but were not sufficient to support the routine use of chelation therapy for treatment of patients who had had an MI. They also commented on the limitations of the study. These included the use of a composite end point, which meant that there was inevitable uncertainty about the actual treatment benefit because the study power was insufficient to show an effect on any individual end point and the components were not all of equal clinical importance. The most frequently observed end point in the study was coronary revascularisation, which was considered "softer" because of the necessary element of physician decision making, although they said that in the study such events were verified by staff who were unaware of which treatment group the patient was in. They also commented that an unusually high number (17%) of patients withdrew from the study, which did lead to some lost data. They also observed that unblinding was a possible explanation for the observation that placebo patients were more likely to discontinue therapy, withdraw consent or be lost to follow-up than chelation patients. They commented that the lack of a well-established hypothesis for the mechanism of any benefit limited their ability to understand and use the results. They also said that 40-infusion regime tested in the study was not easy for patients to receive because each infusion took about three hours, and the first 30 infusions were administered at weekly intervals. Finally, they commented that one trial could not answer all the questions needed to transform a novel hypothesis into a clinical treatment that merited guideline endorsement and that the possibility that the results represented chance findings must be considered, especially in light of the narrow difference between the significance level calculated and that prescribed for the analysis. They said the study did not provide evidence to support the routine use of chelation therapy in clinical practice. Although the study appeared to be robust we noted the limitations of the study acknowledged by its authors, and also that they concluded that the study was not a sufficient basis on which to recommend the routine use of chelation therapy in clinical practice. We therefore did not consider that the study was sufficient to support claims that chelation therapy could treat cardiovascular disease.

Dr Idahosa had also provided information from websites listing the benefits of chelation therapy. However, we considered that this was background information only and was not sufficient to support efficacy claims. He had also provided handwritten copies of various study abstracts. However, because we were not provided with the studies in full so that we could examine them we did not consider that these were sufficient to support efficacy claims. A copy of a web page referred to studies regarding chelation therapy but the studies themselves were not provided in full. A study which analysed improvement in cerebrovascular blood flow following chelation therapy was provided. However, the details of the study were very brief, it did not appear to have been published and was not randomised, controlled or double-blinded. A further study which analysed improved blood flow in cerebrovascular disease following chelation therapy was provided. However, it did not appear to be published, involved only a small number of patients and was not randomised, controlled or double-blinded. We therefore did not consider those studies to be sufficiently robust to support efficacy claims for chelation therapy. We were also provided with information about chelation therapy in India. However, these were handwritten and did not relate to clinical studies so we did not consider them sufficient to support efficacy claims. We were not provided with any full clinical studies relevant to the claims that chelation therapy could "… increase in blood circulation, increased energy levels, enhanced memory and normalised blood pressure. Lost bodily functions may be restored and levels of pain reduced. HDL cholesterol is increased, whilst LDL cholesterol decreases", or that it could be used to treat "Cognitive decline, Diabetes Mellitus, Intermittent claudication, Macular degeneration, Plaque build-ups caused by calcium, Arthritis, Hypertension, Scleroderma, Psoriasis, Parkinson's disease, Neurological conditions, Chronic Fatigue Syndrome".

We considered that the evidence provided was not sufficiently robust to substantiate the claims in the ad that chelation therapy could "… increase in blood circulation, increased energy levels, enhanced memory and normalised blood pressure. Lost bodily functions may be restored and levels of pain reduced. HDL cholesterol is increased, whilst LDL cholesterol decreases" and that it could treat the listed conditions. We therefore concluded that the claims had not been substantiated.

The ad breached CAP Code (Edition 12) rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising),  3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.  (Substantiation) and  12.1 12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
 (Medicines, medical devices, health-related products and beauty products).

Action

The ad must not appear again in its current form. We told Dr P E Idahosa not to make claims that chelation therapy could “… increase in blood circulation, increased energy levels, enhanced memory and normalised blood pressure. Lost bodily functions may be restored and levels of pain reduced. HDL cholesterol is increased, whilst LDL cholesterol decreases” or that it could treat cardiovascular disease, cognitive decline, diabetes mellitus, intermittent claudication, macular degeneration, plaque build-ups caused by calcium, arthritis, hypertension, scleroderma, psoriasis, Parkinson’s disease, neurological conditions or chronic fatigue syndrome.

CAP Code (Edition 12)

12.1     3.1     3.7    


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