ASA
Posted: Thu Jul 04, 2013 9:53 am
ASA - UK'S INDEPENDENT REGULATORS FOR ADVERTISEMENTS ACROSS ALL MEDIA- HAS RULED ON JULY 3 2013 AS FOLLOWS:
A magazine ad for a pro-homeopathy organisation was headlined "Homeopathy cares" and contained 13 claims under the subheadlines "Homeopathy has a history of success in chronic illness", "Homeopathy offers a caring alternative" and "Opposition to homeopathy is based on propaganda".
Six public complainants, two of whom later became associated with the Nightingale Collaboration, challenged whether the following claims could be substantiated:
1. "Homeopathy has a history of success in chronic illness";
2. "At Bristol Homeopathic Hospital 70.7% of 6,500 patients with chronic conditions benefited from homeopathic treatment and had reduced need for conventional medicine";
3. "... more randomised controlled trials are positive than negative"; and
4. "In Cuba, an integrated approach to healthcare has led to homeopathy being used to enable 2.3 million, including the elderly, to be cheaply and effectively protected against endemic Leptospirosis".
The complainants challenged whether the following claims were misleading:
5. "About 6 million people in the UK choose Homeopathy";
6. ". of the 2,500 most commonly used treatments in the NHS, 51% have unknown effectiveness";
7. "Even a small increase in spending on homeopathy could produce dramatic benefits, reducing care needs and increasing patient quality of life";
8. "Sense About Science" is funded by pharmaceutical companies and relies on a strategy of propaganda stunts rather than scientific research"; and
9. "(Trick or Treatment?) has been shown to be scientifically unreliable".
They also challenged whether the following claims were irresponsible or denigratory:
10. "The NHS spends £2 billion annually on treating adverse side effects of conventional drugs. Homeopathy has no side effects";
11. "The leading so-called 'expert' and critic of homeopathy, Professor Edzard Ernst, has admitted that he has no qualifications in homeopathy"; and
12. "The recent Science and Technology Committee report on homeopathy was voted for by only three MPs".
Assessment
The ASA acknowledged that H:MC21 believed the RCTs upon which the ASA relied were limited, because they were capable of producing scientifically invalid conclusions if scientifically invalid parameters were used. We noted H:MC21 believed the clinical evidence that was available supported their claims.
We also noted the House of Commons Science and Technology Committee's EC2 report. We noted that the Committee's investigation was not into homeopathy itself but rather it examined the provisioning of Homeopathy on the NHS and the licensing of the same via the MHRA. We noted that EC2 included an investigation into the evidence for the efficacy of homeopathy, and that part of this investigation involved a public consultation period during which interested parties, including members of the homeopathic community submitted evidence to the Committee.
The Committee agreed that the gold standard of efficacy was randomised, double-blinded, controlled trials. It also concluded that meta-analyses and systematic reviews were useful in increasing the statistical reliability of these trials and therefore in establishing evidence of efficacy. The Committee also concluded that patient satisfaction analysis would not be helpful in proving efficacy.
Whilst noting the policy issues at the source of the Committee's investigation, we nevertheless understood from expert advice that the review of scientific evidence for homeopathy reported in EC2 was a robust and fair examination of the evidence available to it.
During our investigation of H:MC21's marketing, we considered only that part of EC2 that commented on the evidence for the efficacy of homeopathy. We did not consider the investigation's conclusions on the public policy questions asked by the Committee to be relevant in this respect.
1. Upheld
The ASA noted there was a large amount of data and numerous case studies on homeopathy that dated back hundreds of years and understood that there was significant support for the use of homeopathy in the treatment of chronic illnesses. We noted H:MC21's belief that there was significant evidence to support the basic science upon which homeopathy was based and to support more specific claims for successful treatment of chronic disease and illness. However, we noted many of the studies which reported positive outcomes were based on patient self-assessments only, whereas a substantial review of over 100 placebo controlled trials showed no convincing evidence that homeopathy was superior to placebo.
We also noted the publication 'Homeopathy in Healthcare' that H:MC21 submitted in support of their views on RCTs and the ASA's approach to assessing the evidence for homeopathy, as well as in support of the efficacy of homeopathy.
The publication's main conclusion regarding efficacy was drawn from a reconsideration of a previous meta-analysis of qualifying trials which found no significant difference between placebo and homeopathic treatment and had been published in a reputable peer reviewed journal. It featured a reworking of the analysis of the data by considering only therapeutic studies, and removing the prevention studies. This led to the number of significant versus non-significant trials becoming 28 vs. 23, as opposed to 32 vs. 33 in the original publication. The publication's editors described this as "a truly remarkable result in favour of homeopathy". Our expert did not agree with this assertion. However, the authors, in the section that discussed the study, stated, "While the above argument does not allow us to draw the reverse conclusion that homeopathy is effective, it does support the claim that the Shang et al (2005a) study does not prove the ineffectiveness of homeopathy". Our expert agreed with this second statement only.
Our expert pointed out that 'Homeopathy in Healthcare' looked at issues beyond efficacy, such as 'real world effectiveness', safety and economy. This was a wider consideration than those found in conventional medical reviews. However, our expert advised that a problem with studies looking at measures beyond efficacy was that positive effectiveness outcomes could not be differentiated from the result of the placebo effect alone.
After seeking expert advice, we considered that 'Homeopathy in Healthcare' did not move the case forward in favour of the efficacy of homeopathy in treating medical conditions, in light of conventional standards for efficacy. We noted that proponents of the homeopathic approach often objected to conventional medicine's focus on RCTs as the gold standard for assessing efficacy, and instead they favoured other forms of measurement in their assessment, such as patient self-analysis and outcome studies. Nevertheless, we continued to expect claims, that a particular medicine or approach could be used to treat medical conditions, be substantiated with a robust body of evidence, consisting of RCTs conducted on human subjects, where appropriate. We did not consider the alternatives put forward, such as patient self-analysis or outcome studies alone to be suitably robust to support efficacy. Because the 'Homeopathy in Healthcare' did not include robust evidence, of the type we considered necessary, we considered that it was insufficient to substantiate the efficacy claims made in the ad.
We concluded that H:MC21 had not supplied sufficient evidence to substantiate the claim and noted there was a lack of evidence to support claims for its efficacy. We concluded that the ad was misleading.
On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
2. Upheld
We considered that most readers would interpret the claim "At a Bristol Homeopathic Hospital 70.7% of 6,500 patients with chronic conditions benefited from homeopathic treatment and had reduced need for conventional medicine" to mean that the study demonstrated that over 70% of the patients tested experienced a reduction in the symptoms of their chronic illness following the introduction of homeopathic treatment. We noted the study contained patients' self-assessments of their health following GP referral to a homeopathic hospital before, during and after the introduction of the homeopathic treatment and that the study reported 50.7% reported the improvement in their symptoms as 'much better' and that in all, 70.7% of patients had reported a degree of improvement . However, we considered that because there was no in-depth objective clinical assessment of patients' observable conditions following the introduction of homeopathic treatment, the evidence was not capable of substantiating the claim. We noted several other similar studies had also been carried out and noted those reports, and independent assessments of those reports had stated that many of the patients who were included in the studies reported a reduced reliance on conventional medicine. However, we considered that in the context of the text directly underneath the headline "Homeopathy has a history of success in chronic illness", the claim implied that it had been shown in those cases that any improvement and subsequent reduction in their reliance on conventional medicine was directly related to the homeopathic treatment provided. Because H:MC21 had not demonstrated that, we concluded that the claim was misleading.
On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
3. Upheld
We noted H:MC21's reasoning for not including the percentage of studies that had inconclusive findings. However, we considered that the statement was likely to be interpreted by the average reader as a claim that RCTs on homeopathy demonstrated that the science behind homeopathy was substantiated because more "positive" than "negative" results were achieved. We noted the assessment of the Faculty of Homeopathy, the British Homeopathic Association and the Complementary Medicine Research Group at the University of York to the Commons Science and Technology Committee evidence stated that 44% of findings reported positive results, 7% reported negative results and that 49% reported "inconclusive" results. We considered that within the context of the claim ". more randomised trials are positive than negative", the 49% of inconclusive results was a significant piece of information and should have been included in the ad because it indicated that under RCT conditions, inconclusive results had occurred more often than positive results. Because this information was omitted, we concluded that the ad was misleading.
On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
4. Upheld
We considered that most consumers would interpret the claim "In Cuba, an integrated approach to healthcare has led to homeopathy being used to enable 2.3 million, including the elderly, to be cheaply and effectively protected against endemic Leptospirosis", to mean that homeopathy had been used to protect against the disease as a result of an integrated approach to a health crisis. We noted a homeopathic medicine had been used as part of the treatment of Leptospirosis prevention in Cuba and that during the same year and the years that followed, it had been reported that incidences of the disease had decreased significantly. We noted evidence had not been supplied to demonstrate that the homeopathic medicine referred to in the report had been shown to be efficacious against Leptospirosis under clinical conditions and therefore considered that the vast reduction in the incidences of the disease had not been shown to be directly attributed to the homeopathic remedy that had been administered. We therefore concluded that the claim was misleading.
On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
Action
The ad should not appear again in its current form.
http://www.asa.org.uk/Rulings/Adjudicat ... 39800.aspx
A magazine ad for a pro-homeopathy organisation was headlined "Homeopathy cares" and contained 13 claims under the subheadlines "Homeopathy has a history of success in chronic illness", "Homeopathy offers a caring alternative" and "Opposition to homeopathy is based on propaganda".
Six public complainants, two of whom later became associated with the Nightingale Collaboration, challenged whether the following claims could be substantiated:
1. "Homeopathy has a history of success in chronic illness";
2. "At Bristol Homeopathic Hospital 70.7% of 6,500 patients with chronic conditions benefited from homeopathic treatment and had reduced need for conventional medicine";
3. "... more randomised controlled trials are positive than negative"; and
4. "In Cuba, an integrated approach to healthcare has led to homeopathy being used to enable 2.3 million, including the elderly, to be cheaply and effectively protected against endemic Leptospirosis".
The complainants challenged whether the following claims were misleading:
5. "About 6 million people in the UK choose Homeopathy";
6. ". of the 2,500 most commonly used treatments in the NHS, 51% have unknown effectiveness";
7. "Even a small increase in spending on homeopathy could produce dramatic benefits, reducing care needs and increasing patient quality of life";
8. "Sense About Science" is funded by pharmaceutical companies and relies on a strategy of propaganda stunts rather than scientific research"; and
9. "(Trick or Treatment?) has been shown to be scientifically unreliable".
They also challenged whether the following claims were irresponsible or denigratory:
10. "The NHS spends £2 billion annually on treating adverse side effects of conventional drugs. Homeopathy has no side effects";
11. "The leading so-called 'expert' and critic of homeopathy, Professor Edzard Ernst, has admitted that he has no qualifications in homeopathy"; and
12. "The recent Science and Technology Committee report on homeopathy was voted for by only three MPs".
Assessment
The ASA acknowledged that H:MC21 believed the RCTs upon which the ASA relied were limited, because they were capable of producing scientifically invalid conclusions if scientifically invalid parameters were used. We noted H:MC21 believed the clinical evidence that was available supported their claims.
We also noted the House of Commons Science and Technology Committee's EC2 report. We noted that the Committee's investigation was not into homeopathy itself but rather it examined the provisioning of Homeopathy on the NHS and the licensing of the same via the MHRA. We noted that EC2 included an investigation into the evidence for the efficacy of homeopathy, and that part of this investigation involved a public consultation period during which interested parties, including members of the homeopathic community submitted evidence to the Committee.
The Committee agreed that the gold standard of efficacy was randomised, double-blinded, controlled trials. It also concluded that meta-analyses and systematic reviews were useful in increasing the statistical reliability of these trials and therefore in establishing evidence of efficacy. The Committee also concluded that patient satisfaction analysis would not be helpful in proving efficacy.
Whilst noting the policy issues at the source of the Committee's investigation, we nevertheless understood from expert advice that the review of scientific evidence for homeopathy reported in EC2 was a robust and fair examination of the evidence available to it.
During our investigation of H:MC21's marketing, we considered only that part of EC2 that commented on the evidence for the efficacy of homeopathy. We did not consider the investigation's conclusions on the public policy questions asked by the Committee to be relevant in this respect.
1. Upheld
The ASA noted there was a large amount of data and numerous case studies on homeopathy that dated back hundreds of years and understood that there was significant support for the use of homeopathy in the treatment of chronic illnesses. We noted H:MC21's belief that there was significant evidence to support the basic science upon which homeopathy was based and to support more specific claims for successful treatment of chronic disease and illness. However, we noted many of the studies which reported positive outcomes were based on patient self-assessments only, whereas a substantial review of over 100 placebo controlled trials showed no convincing evidence that homeopathy was superior to placebo.
We also noted the publication 'Homeopathy in Healthcare' that H:MC21 submitted in support of their views on RCTs and the ASA's approach to assessing the evidence for homeopathy, as well as in support of the efficacy of homeopathy.
The publication's main conclusion regarding efficacy was drawn from a reconsideration of a previous meta-analysis of qualifying trials which found no significant difference between placebo and homeopathic treatment and had been published in a reputable peer reviewed journal. It featured a reworking of the analysis of the data by considering only therapeutic studies, and removing the prevention studies. This led to the number of significant versus non-significant trials becoming 28 vs. 23, as opposed to 32 vs. 33 in the original publication. The publication's editors described this as "a truly remarkable result in favour of homeopathy". Our expert did not agree with this assertion. However, the authors, in the section that discussed the study, stated, "While the above argument does not allow us to draw the reverse conclusion that homeopathy is effective, it does support the claim that the Shang et al (2005a) study does not prove the ineffectiveness of homeopathy". Our expert agreed with this second statement only.
Our expert pointed out that 'Homeopathy in Healthcare' looked at issues beyond efficacy, such as 'real world effectiveness', safety and economy. This was a wider consideration than those found in conventional medical reviews. However, our expert advised that a problem with studies looking at measures beyond efficacy was that positive effectiveness outcomes could not be differentiated from the result of the placebo effect alone.
After seeking expert advice, we considered that 'Homeopathy in Healthcare' did not move the case forward in favour of the efficacy of homeopathy in treating medical conditions, in light of conventional standards for efficacy. We noted that proponents of the homeopathic approach often objected to conventional medicine's focus on RCTs as the gold standard for assessing efficacy, and instead they favoured other forms of measurement in their assessment, such as patient self-analysis and outcome studies. Nevertheless, we continued to expect claims, that a particular medicine or approach could be used to treat medical conditions, be substantiated with a robust body of evidence, consisting of RCTs conducted on human subjects, where appropriate. We did not consider the alternatives put forward, such as patient self-analysis or outcome studies alone to be suitably robust to support efficacy. Because the 'Homeopathy in Healthcare' did not include robust evidence, of the type we considered necessary, we considered that it was insufficient to substantiate the efficacy claims made in the ad.
We concluded that H:MC21 had not supplied sufficient evidence to substantiate the claim and noted there was a lack of evidence to support claims for its efficacy. We concluded that the ad was misleading.
On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
2. Upheld
We considered that most readers would interpret the claim "At a Bristol Homeopathic Hospital 70.7% of 6,500 patients with chronic conditions benefited from homeopathic treatment and had reduced need for conventional medicine" to mean that the study demonstrated that over 70% of the patients tested experienced a reduction in the symptoms of their chronic illness following the introduction of homeopathic treatment. We noted the study contained patients' self-assessments of their health following GP referral to a homeopathic hospital before, during and after the introduction of the homeopathic treatment and that the study reported 50.7% reported the improvement in their symptoms as 'much better' and that in all, 70.7% of patients had reported a degree of improvement . However, we considered that because there was no in-depth objective clinical assessment of patients' observable conditions following the introduction of homeopathic treatment, the evidence was not capable of substantiating the claim. We noted several other similar studies had also been carried out and noted those reports, and independent assessments of those reports had stated that many of the patients who were included in the studies reported a reduced reliance on conventional medicine. However, we considered that in the context of the text directly underneath the headline "Homeopathy has a history of success in chronic illness", the claim implied that it had been shown in those cases that any improvement and subsequent reduction in their reliance on conventional medicine was directly related to the homeopathic treatment provided. Because H:MC21 had not demonstrated that, we concluded that the claim was misleading.
On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
3. Upheld
We noted H:MC21's reasoning for not including the percentage of studies that had inconclusive findings. However, we considered that the statement was likely to be interpreted by the average reader as a claim that RCTs on homeopathy demonstrated that the science behind homeopathy was substantiated because more "positive" than "negative" results were achieved. We noted the assessment of the Faculty of Homeopathy, the British Homeopathic Association and the Complementary Medicine Research Group at the University of York to the Commons Science and Technology Committee evidence stated that 44% of findings reported positive results, 7% reported negative results and that 49% reported "inconclusive" results. We considered that within the context of the claim ". more randomised trials are positive than negative", the 49% of inconclusive results was a significant piece of information and should have been included in the ad because it indicated that under RCT conditions, inconclusive results had occurred more often than positive results. Because this information was omitted, we concluded that the ad was misleading.
On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
4. Upheld
We considered that most consumers would interpret the claim "In Cuba, an integrated approach to healthcare has led to homeopathy being used to enable 2.3 million, including the elderly, to be cheaply and effectively protected against endemic Leptospirosis", to mean that homeopathy had been used to protect against the disease as a result of an integrated approach to a health crisis. We noted a homeopathic medicine had been used as part of the treatment of Leptospirosis prevention in Cuba and that during the same year and the years that followed, it had been reported that incidences of the disease had decreased significantly. We noted evidence had not been supplied to demonstrate that the homeopathic medicine referred to in the report had been shown to be efficacious against Leptospirosis under clinical conditions and therefore considered that the vast reduction in the incidences of the disease had not been shown to be directly attributed to the homeopathic remedy that had been administered. We therefore concluded that the claim was misleading.
On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
Action
The ad should not appear again in its current form.
http://www.asa.org.uk/Rulings/Adjudicat ... 39800.aspx
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