Posted 17 April 2013
Rychol claims to reduce cholesterol. Pharmachoice laid a complaint against this claim with the ASA. The ASA ruled against the claims. Rychol appealed and asked a retired professor, Professor Van Gelder, to substantiate the claims for the product. Reading his report, he appears to NOT unequivocally support the claims, but then says that he evaluated the data that the company itself supplied, and therefore that the claims for Rychol are true. It is unfathomable that any scientist would accept unpublished, non-peer-reviewed data at face value of a company selling a product, and claiming that the data will suffice!
We have evaluated the evidence on studies for the individual ingredients, some combined with other ingredients used in Rychol, and simply they do not add up. For example, Rychol uses berberine at 60-120 mg per day (Cholesterol levels above 5 : take 2 tablets per day; above 6: take 3 tablets per day; above 7: take 4 tablets per day). Peer reviewed studies used berberine 500 mg twice a day , berberine 500mg, policosanol 10mg and red yeast rice 200mg per day , 500 mg berberine orally three times a day 
A recent review concluded: “longer trials are needed to better evaluate the safety profile of the molecule, when administered alone or in association with other anti-hyperlipidemic or anti-diabetic drugs” 
Rychol also uses Coenzyme Q10 and Red Yeast Rice. The very reputable Natural Medicines Comprehensive Database states for Coenzyme q10:
“POSSIBLY INEFFECTIVE: Hyperlipidemia. One clinical study in obese patients shows that taking coenzyme Q-10 200 mg daily for 12 weeks does not significantly reduce total cholesterol, triglycerides, or oxidized low density lipoprotein (LDL); or increase high density lipoprotein (HDL) compared to placebo (17704)“.
For Red Yeast Rice:
“POSSIBLY EFFECTIVE – Hyperlipidemia. Some clinical research shows that taking specific red yeast rice products (Cholestin, Pharmanex, and others) 1.2-3.15 grams daily can significantly lower total and low-density lipoprotein (LDL) cholesterol levels, and triglycerides when used for 8-12 weeks (2624, 6988, 6993, 16656). However, these products provided up to about 10 mg daily of HMG-CoA reductase inhibitors, similar to “statin” drugs, such as lovastatin.
Other clinical research shows that taking a specific red yeast rice product (Red Yeast Rice, Sylvan Bioproducts) 1800 mg twice daily, providing about 6 mg of lovastatin daily, significantly lowers total and LDL cholesterol compared to placebo when used for 12-24 weeks (16836). The same red yeast rice product, taken in a dose of 2400 mg twice daily, was comparable to taking pravastatin 20 mg twice daily for lowering LDL-cholesterol in another clinical trial lasting 12 weeks (17089). In the US, the Food and Drug Administration (FDA) considers red yeast rice products that contain statins to be illegal unapproved drugs (6610). Some red yeast rice products available in the US contain little or no statins; however, many still contain significant concentrations of statins. One analysis shows that that some of these products can contain up to 5 mg of statins per tablet (16655). It is not known if the red yeast rice products that contain a lower concentration of statins significantly reduce cholesterol levels in patients with hyperlipidemia.”
Natural Medicines Comprehensive Database defines POSSIBLY EFFECTIVE as “this product has some clinical evidence supporting its use for a specific indication; however, the evidence is limited by quantity, quality, or contradictory findings. Products rated ‘Possibly Effective’ might be beneficial, but do not have enough high-quality evidence to recommend for most people.“
Rychol uses Red Yeast Rice at 1,000 – 2,000mg per day. Compare this with the above dosages. The most damning conclusion is reached by the journal that promotes complementary medicines (Complementary Therapies in Medicine) which concluded in a December 2012 review: “Results of Red Yeast Rice (RYR) clinical trials presented here have limitations and RYR’s clinical use should be further investigated before using RYR as one of the alternative treatments for dyslipidemia management, despite the fact that the strongest evidence for RYR use is in dyslipidemia versus other clinical conditions.” 
So the conclusion is clear from experts, that the evidence does not support Rychol. However, a Professor van Gelder claimed that the companies internal study supported the claims and the ASA ruled in the company’s favour, which is strange for the study was not independent, and secondly, the evidence from published studies do not support the possibility that the product would work. Extraordinary claims require extraordinary evidence!
[note note_color=”#effcb5″]Rychol / Phamachoice / 20171 (AIT)
Ruling of the : Advertising Industry Tribunal
In the matter between:
Winthrop Pharmaceuticals (Pty) Limited Complainant(s)/Appellant(s)
Medical Institute South Africa (Pty) Limited Respondent[/note]
26 Mar 2013
In a ruling dated 5 July 2012, the DIRECTORATE accepted the respondent’s voluntary undertaking to withdraw or amend its advertising.
The undertaking was accepted on condition that the advertisements in their current format were “withdrawn within the deadlines stipulated in Clause 15.3 of the Procedural Guide, and are not used again in future”. With regard to the RyChol packaging, it was specifically noted that “the packaging must be phased out by 5 September 2012”.
In addition to this, the DIRECTORATE specifically drew the respondent’s attention to the provisions of Clause 15.5 of the Procedural Guide.
The packaging submitted as part of the complaint stated, inter alia, as follows:
“Combats high cholesterol”; and
“RyChol … consists of a combination of natural compounds that display different but synergistic cholesterol lowering effects.”
The pharmacy shelf display submitted stated, inter alia: “Combat high cholesterol without prescription drugs …”
SUBSEQUENT TO THE RULING
On 30 July 2012 Attorneys Edward Nathan Sonnenbergs, on behalf of the complainant, lodge a breach complaint against the respondent’s radio commercial for its Rychol product, which was broadcast on 5FM on 26 July 2012. It submitted that the new commercial contained the claim “combat cholesterol with Rychol” in clear contravention of the undertaking as noted in the ruling.
In terms of Clause 15.3.2 of the Procedural Guide, the deadline for withdrawal of radio advertising is “immediately as deadlines permit”. Accordingly the new radio commercial should not have been broadcast more than one or two days after the date of the ruling.
The complainant further requested the DIRECTORATE to exercise its discretion, in terms of Clause 14.6 of the Procedural Guide, and impose sanction in the event of non-adherence.
RELEVANT CLAUSE OF THE CODE OF ADVERTISING PRACTICE
In light of the breach allegation the DIRECTORATE considered Clause 15 of the Procedural Guide (Enforcement of rulings) as relevant.
Attorneys Erasmus De Klerk Inc, on behalf of the respondent, denied acting in breach of the previous ruling. It referred to its letter of response dated 5 June 2012, in which it undertook to withdraw the “material referred to in the complaint” without acknowledging any liability. At no stage did it make any reference to Clause 15.3 of the Procedural Guide, nor did it intend to do so. Its understanding in making the undertaking was that all material, including advertising material and not just packaging, would be phased out within three month period.
It added that under the circumstances, even where there is an alleged breach of the Code after the ruling (which is denied) such breach was certainly not wilful. The respondent further explained the steps taken as a result of the undertaking which included extensive consultation with the respondent’s legal representatives and an expert in the field. The packaging material was amended in line with the recommendation of the expert.
To the extent that the complainant suggests that the claim that Rychol “combat[s] high cholesterol” was also improper, it disagrees, because it never gave an undertaking or acknowledged any liability that such a claim was incorrect. It elaborated on why it believes it was entitled to make this claim despite the previous ruling, noting that it has since amended its packaging insert to specifically state that it regards “high cholesterol” as “cholesterol levels above 4.9mmol/l”, and that it holds adequate substantiation.
To the extent that its attention was drawn to Clause 15.5 of the Procedural Guide, it has complied with its undertaking and not in breach of the ASA’s ruling.
ASA DIRECTORATE RULING
The ASA DIRECTORATE considered the relevant documentation submitted by the respective parties.
The essential question before the DIRECTORATE is whether or not the respondent’s advertisement is in breach of the original ruling. For this to be the case, the respondent would have to be making the same, or materially similar claims to those originally complained of.
The respondent insists that the complainant cannot now allege that the claim that RyChol combats high cholesterol is problematic on the strength of the undertaking given in relation to its packaging, as these are separate issues.
The DIRECTORATE does not share this view for two reasons:
While the original complaint was supported by, inter alia, packaging examples, paragraph 7.3 of the complaint specifically stated “Please note that this complaint is not limited to the Advertising Materials, but is against the claims wherever they might appear, and that Clause 15.5 of the ASA Procedural Guide should apply in this regard”. This makes it clear that the complainant’s main gripe relates to the claims used, and not only the packaging and in-store examples submitted,
The original ruling specifically drew attention to the provisions of Clause 15.5 of the Procedural Guide, which reads “Offending advertising is to be withdrawn from every medium in which it appears, notwithstanding that the complaint did not specifically refer to that particular medium”.
From these two factors alone it is evident that the respondent was compelled to give effect to its undertaking across all media, and that the undertaking would apply to the claims disputed.
Similarly, the argument that its undertaking should be interpreted to mean that “… all material, including advertising material and not just packaging, would be phased out within a 3 month period …” is rejected. Clause 15.3 of the Procedural Guide provides clear guidelines as to when advertising has to be removed for each specific media-type. The only media that has a three month deadline for withdrawal is packaging, and it is unclear why the respondent assumed it could take three months to withdraw any other advertising. In any event, it made no request for leniency in this regard.
The radio commercial at issue was broadcast nearly two weeks after the initial ruling. It states:
“There is a silent killer in our midst endangering the lives of 70% of our adult population. Cholesterol. Causing heart diseases and death. Check your cholesterol levels and COMBAT HIGH CHOLESTEROL WITH RYCHOL. Rychol has a very low side-effect profile developed by the Medical Nutritional Institute. Rychol, South Africa’s leading non-prescription cholesterol combating brand” (emphasis added).
Clearly this still communicates one of the claims previously complained of, and does so in contravention of the respondent’s voluntary undertaking.
Given this, the commercial was in breach of the previous ruling, and therefore in contravention of Clause 15 of the Procedural Guide.
Under ordinary circumstances, the DIRECTORATE would consider whether or not sanctions were warranted.
However, a cursory view of rulings stored on the ASA’s electronic archives reveals that the respondent does not have a history of adverse rulings from the ASA. In fact, other than the original ruling in this matter, it would appear that the respondent has not been hauled before the ASA as a respondent in some years.
Accordingly, the DIRECTORATE did not believe sanctions were appropriate at the time.
The respondent was cautioned, however, that the responsibility to ensure compliance with the ASA ruling lies with it. Should the DIRECTORATE uphold further justified breach allegations, it may take this ruling into account when considering the imposition of sanctions.
The breach allegation was therefore upheld, with no additional sanctions imposed on the respondent other than the immediate withdrawal of the claim, “combat high cholesterol …” from any media in which it currently appears.
THE APPEAL (AND APPLICATION FOR CONDONATION)
On the 4 September 2012 the appellant filed an application for condonation against the DIRECTORATE’s rulings of 5th July and 16th August. Condonation was granted on the 20th of November by the Chairperson of the AIT.
The appellant claimed that the DIRECTORATE had misinterpreted its undertaking dated 5th June 2012 and that it had not intended to withdraw its claim “Combat High Cholestrol” in its advertising material and that the DIRECTORATE had not considered the merits of the matter in issuing its ruling when deciding on the breach ruling on the 16th August 2012. Attached to the appeal was the report of an independent expert Professor A L Van Gelder providing substantiation for the claim “Combat High Cholestrol”. The appellant asked that the DIRECTORATE ruling of the 5th July and 16th August be set aside with costs.
RESPONSE TO THE NOTICE OF APPEAL
The response of appeal was filed on the 11th January 2013 after the respondent became aware of the granting of the condonation on the 12th December 2012. In essence the respondent argues that the appellant should be held to its undertaking. The respondent does not dispute the expertise of Professor Van Gelder but challenges the methodologies used in reaching the opinion expressed in the report. It also argues that the conclusions in the report are not supported by the report and asked that the appeal be dismissed with costs.
At the hearing the appellant was represented by Marion Du Plessis CEO and Dr Conrad Smith a director of the .appellant The focus of the hearing was to draw the Tribunals attention to the experts report and highliting that no contradictory expert report had been filed and accordingly the conclusion of the expert that the clinical data substantiated the claims “Rychol-Q10 might be affective to lower cholesterol and LDL cholesterol” and that a person can “combat high cholesterol by using Rychol-Q10” was uncontested.
The respondent was represented by Dr Rashem Mothilal. The essence of the respondent’s submission was again to attack the methodology used to conduct the clinical trials The respondent was asked why no independent medical opinion had been submitted and the response was that one could be obtained.
The view of the Tribunal was that the undertaking given by the appellant dated 5th June 2012 was poorly worded and that the DIRECTORATE should never have construed that as an unequivocal undertaking or should at least have sort clarity from the appellant as to the nature and scope of the undertaking. Based on the facts before the Tribunal it is clear that the continued use of the word combats high cholesterol was only substantiated at the earliest on the 4th September 2012 and therefore the DIRECTORATE’s ruling that the appellant had breached the ruling of the 5th July as at the 16th August is correct.
It is clear from rule 4.1.1 of the Code that if an advertiser wishes to make a claim it should have substantiation at hand at the time of making the claim. The appellant was only able to provided substantiation as at 4th September 2012 once it had been given leave to appeal the DIRECTORATE’s ruling dated 5th July 2012.
Regarding the issue of considering expert opinions, the ASA has advised on numerous occasions the members of its committees are not experts and rely on the parties to provided guidance to them in dealing with expert opinions. The opinion provided by Professor Van Gelder was in the view of the majority of the Tribunal sufficiently well reasoned and clear to support the claims made by the appellant as set out above. The respondent had the opportunity to submit its own expert opinion but chose not to do so though apparently it could have. It did not object to the experts report as part of the appeal and it fact delves into the merit of the report
Accordingly in the view of the Tribunal the appellant ‘s claims as set out in the experts report were substantiated, but only as at the 4th September and it was in breach of the DIRECTORATE’s ruling of the 5th July as at the 16th of August and that the adverse ruling stands against the appellant . The DIRECTORATES ruling of 5 July is set aside as from to-days date.
In the view of the Tribunal there should be no order as to costs.
|Expert Opin Biol Ther. 2013 Feb 27. [Epub ahead of print]Effects of berberine on lipid profile in subjects with low cardiovascular risk.Derosa G, D’Angelo A, Bonaventura A, Bianchi L, Romano D, Maffioli P.Source University of Pavia, Department of Internal Medicine and Therapeutics, Fondazione IRCCS Policlinico S. Matteo , P.le C. Golgi, 2 – 27100 Pavia , Italy +39 0382 526217 ; +39 0382 526259 ; [email protected]Abstract|
Objective: To evaluate the efficacy as antihypercholesterolemic agent of berberine in patients with low cardiovascular risk.
Research design and methods: 144 Caucasian subjects were enrolled. After a 6-month run-in period following diet and practicing physical activity, patients were randomized to take placebo or berberine 500 mg twice a day, for 3 months, in a double-blind, placebo-controlled design. Berberine and placebo were then interrupted for 2 months (washout period), and all patients continued with only diet and physical activity. At the end of the washout period, patients restarted berberine or placebo twice a day for further 3 months. Anthropometric and metabolic parameters were assessed during the run-in period, at randomization, before and after the washout period.
Results: A decrease of body weight and BMI was observed after the run-in period. Berberine reduced total cholesterol, triglycerides and LDL cholesterol and increased HDL cholesterol after 3 months from randomization and compared with placebo. After the washout period, lipid profile worsened; afterward, when berberine was reintroduced, lipid profile improved again both compared with the washout period, and with placebo.
Conclusions: Berberine is effective and safe to mildly improve lipid profile in subjects with low risk for cardiovascular disease.
|Nutraceutical pill containing berberine versus ezetimibe on plasma lipid pattern in hypercholesterolemic subjects and its additive effect in patients with familial hypercholesterolemia on stable cholesterol-lowering treatment.Pisciotta L, Bellocchio A, Bertolini S.Source Department of Internal Medicine, University of Genoa, Viale Benedetto XV n. 6, 16132, Genoa, Italy.Abstract|
Although statins (STs) are drugs of first choice in hypercholesterolemic patients, especially in those at high cardiovascular risk, some of them are intolerant to STs or refuse treatment with these drugs. In view of this, we have evaluated the lipid-lowering effect of a nutraceutical pill containing berberine (BBR) and of ezetimibe, as alternative treatments, in monotherapy or in combination, in 228 subjects with primary hypercholesterolemia (HCH), with history of STs intolerance or refusing STs treatment. In addition, since PCSK9 was found up-regulated by STs dampening their effect through an LDL receptors (LDLRs) degradation, and BBR suppressed PCSK9 expression in cellular studies, we supplemented the stable lipid-lowering therapy of 30 genotype-confirmed Familial Hypercholesterolemia heterozygotes (HeFH) with BBR, searching for a further plasma cholesterol reduction. Plasma lipid pattern was evaluated at baseline and during treatments.
In HCH subjects the nutraceutical pill resulted more effective than EZE in lowering LDL cholesterol (-31.7% vs -25.4%, P < 0.001) and better tolerated. On treatment, LDL-C level below 3.36 mmol/L (≤130 mg/dl) was observed in 28.9% of subjects treated with the nutraceutical pill and 11.8% of those treated with EZE (P <0.007). In the group treated with EZE the subjects carrying the G allele of the g.1679 C > G silent polymorphism of NPC1L1 gene showed a higher response to EZE than homozygous for the common allele (GG + CG: LDL-C -29.4±5.0%, CC -23.6±6.5%, P <0.001). Combined treatment with these drugs was as effective as STs in moderate doses (LDL cholesterol -37%, triglycerides -23%). In HeFH patients the addition of BBR resulted in LDL cholesterol reductions inversely related to those induced by the stable therapy (r = -0.617, P <0.0001), with mean 10.5% further decrease.
The alternative treatments tested in our HCH subjects were rather effective and safe. The findings in HeFH patients suggest that BBR might act in vivo increasing expression and stability of LDLRs and/or suppressing PCSK9 expression.
270 subjects were randomized by lot on 2:1 basis either to a treatment with a nutraceutical-combined pill (containing berberine 500mg, policosanol 10mg and red yeast rice 200mg; BBR/P/RR) or ezetimibe 10mg/day (EZE) for six months.
|Phytomedicine. 2012 Jul 15;19(10):861-7. doi: 10.1016/j.phymed.2012.05.009. Epub 2012 Jun 26.Lipid-lowering effect of berberine in human subjects and rats.Hu Y, Ehli EA, Kittelsrud J, Ronan PJ, Munger K, Downey T, Bohlen K, Callahan L, Munson V, Jahnke M, Marshall LL, Nelson K, Huizenga P, Hansen R, Soundy TJ, Davies GE.Source Avera Institute for Human Genetics, Sioux Falls, SD 57108, USA. [email protected]Abstract |
Due to serious adverse effects and the limited effectiveness of currently available pharmacological therapies for obesity, many research efforts have focused on the development of drugs from natural products. Our previous studies demonstrated that berberine, an alkaloid originally isolated from traditional Chinese herbs, prevented fat accumulation in vitro and in vivo. In this pilot study, obese human subjects (Caucasian) were given 500 mg berberine orally three times a day for twelve weeks. The efficacy and safety of berberine treatment was determined by measurements of body weight, comprehensive metabolic panel, blood lipid and hormone levels, expression levels of inflammatory factors, complete blood count, and electrocardiograph. A Sprague-Dawley rat experiment was also performed to identify the anti-obesity effects of berberine treatment. The results demonstrate that berberine treatment produced a mild weight loss (average 5 lb/subject) in obese human subjects. But more interestingly, the treatment significantly reduced blood lipid levels (23% decrease of triglyceride and 12.2% decrease of cholesterol levels) in human subjects. The lipid-lowering effect of berberine treatment has also been replicated in the rat experiment (34.7% decrease of triglyceride and 9% decrease of cholesterol level). Cortisol, calcitriol, ACTH, TSH, FT4, and SHBG levels were not significantly changed following 12 weeks of berberine treatment. However, there was interestingly, an increase in calcitriol levels seen in all human subjects following berberine treatment (mean 59.5% increase, p=0.11). Blood inflammatory factors (CRP, IL-6, TNFα, COX-2) and erythrocyte sedimentation rate (ESR) were not significantly affected by treatment with berberine. Tests of hematological, cardiovascular, liver, and kidney function following berberine treatment showed no detrimental side effects to this natural compound. Collectively, this study demonstrates that berberine is a potent lipid-lowering compound with a moderate weight loss effect, and may have a possible potential role in osteoporosis treatment/prevention.
|Expert Opin Biol Ther. 2012 Aug;12(8):1113-24. doi: 10.1517/14712598.2012.704014.Berberine on metabolic and cardiovascular risk factors: an analysis from preclinical evidences to clinical trials.Derosa G, Maffioli P, Cicero AF.Source University of Pavia, Department of Internal Medicine and Therapeutics, Fondazione IRCCS Policlinico S. Matteo, P.le C. Golgi, 2-27100 Pavia, Italy. [email protected]Abstract|
|Complement Ther Med. 2012 Dec;20(6):466-74. doi: 10.1016/j.ctim.2012.07.004. Epub 2012 Aug 17.|
The effect of red yeast rice (Monascus purpureus) in dyslipidemia and other disorders.
Yang CW, Mousa SA.
SourceThe Pharmaceutical Research Institute at the Albany College of Pharmacy and Health Sciences, Rensselaer, NY 12144, USA.
Results of RYR clinical trials presented here have limitations and RYR’s clinical use should be further investigated before using RYR as one of the alternative treatments for dyslipidemia management, despite the fact that the strongest evidence for RYR use is in dyslipidemia versus other clinical conditions.