Oscillococcinum – ASA ruling

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Posted 26 April 2012 

Consumer complaints were lodged against a Boiron laboratories television commercial as promoting the product Occilococcinum. The voice-over states, “When flu symptoms appear, take Oscillococcinum immediately”, “Take Oscillococcinum immediately for the relief of flu symptoms” and “Oscillococcinum, homeopathic medicine from Boiron laboratories”.

In essence the complainants submitted that the implied efficacy of the product is unsubstantiated and misleading. The complainants explained that this product is nothing more than duck liver and heart, which has been processed, and then diluted to a measure of one part liver/heart extract to 100200 parts water (100 to the power of 200). As such, there are literally no heart/liver molecules left in the final product solution. What’s more, there is no evidence to show that consuming duck liver/heart has any effect on the flu.

The ASA ruled in favour of the complainants.

OSCILLOCOCCINUM / Z JOUBERT & OTHERS / 18385
Ruling of the : ASA Directorate
In the matter between:
ADV ZACH JOUBERT DR HARRIS STEINMAN Complainant(s)/Appellant(s)
BOIRON LABORATORIES GLENMARK (PTY) LTD LEBRON PHARMACEUTICALS (PTY) LTD Respondent  

14 Dec 2011

http://www.asasa.org.za/ResultDetail.aspx?Ruling=5911&Keyword=18385

Consumer complaints were lodged against a Boiron laboratories television commercial as promoting the product Occilococcinum. Reference was also made to claims appearing on the www.lebron.co.za website among others.

The animated commercial shows a father and daughter travelling by bus, with other passengers coughing around them. Each time a person coughs, the father and daughter turns slightly more red in the face and nose. The voice-over states, “When flu symptoms appear, take Oscillococcinum immediately”, “Take Oscillococcinum immediately for the relief of flu symptoms” and “Oscillococcinum, homeopathic medicine from Boiron laboratories”. During this, the father pulls on the emergency brake, and the two of them are “transported” home, where each take a dose of the advertised product.

COMPLAINT
In essence the complainants submitted that the implied efficacy of the product is unsubstantiated and misleading. The complainants explained that this product is nothing more than duck liver and heart, which has been processed, and then diluted to a measure of one part liver/heart extract to 100200 parts water (100 to the power of 200). As such, there are literally no heart/liver molecules left in the final product solution. What’s more, there is no evidence to show that consuming duck liver/heart has any effect on the flu.

The first complainant took issue with the fact that there is only passing reference to the fact that this is a homeopathic medicine, and as such, people who are not familiar with the implications of how this practice prepares medicine would be misled into expecting efficacy where none exists, perhaps even causing consumers to forgo other treatments in favour of the product.

RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint the following clauses were taken into consideration:

• Section II clause 4.1 – Substantiation

• Section II clause 4.2.1 – Misleading claims

RESPONSE
Response from Stefan Vos Marketing Regulation Advisers.

Stefan Vos Marketing Regulation advisers, on behalf of the respondent, submitted that the television commercial has a disclaimer stating, “Consult your doctor if symptoms persist” as well as the legal disclaimer, “Oscillococcinum Flu Granules: Ana Barbariae Hepatis et Cordis Extr. 200K, U2151 (Act 101/1965) www.lebron.co.za”. The overall take out of the commercial is therefore that Oscillococcinum, a homeopathic medicine from Boiron Laboratories, relieves flu symptoms.

Mr Vos was at pains to point out that the product claims to treat the symptoms of flu, not to prevent flu. He added that the product is currently registered as a homeopathic medicine in 20 countries, and provided a list of these countries, the date of registration as well as the therapeutic indications (which include flu-like symptoms, fever, chills, malaise, pain, body aches, headaches, runny nose, cough, ear complications, muscle and peri-articular pain).

The argument was made that the therapeutic indications registered in these countries indicate that Oscilococcinum treats the symptoms of flu, namely chills, body aches, fever, headaches. These registrations therefore support the television claim as well as the website claim, “Oscillococcinum is the proven solution for the prevention and treatment of flu symptoms”.

In addition to this, the argument was advanced that the respondents are legitimately entitled continue selling this product until such time as the Medicines Control Council (the MCC) decides otherwise. Oscillococcinum was submitted to the MCC for registration more than 25 years ago and has since been awaiting registration. The claims made do not go beyond those indicated in the package insert which is awaiting approval.

In view of the fact that the international registration of Oscillococcinum support the efficacy claims, the ASA should accept, in accordance with the principle established in Bobtail Natures Best / Mars / 14136 (30 July 2010) that the certificates of registration constitute acceptable substantiation within the meaning of the ASA Code. It would be inappropriate for the ASA to interfere with the respondent’s vested rights in this product without the MCC making any determination.

It added that the matter is indeed complex and novel, and the ASA Directorate requires outside assistance by means of co-option as catered for in the Procedural Guide. It recommended that the ASA consults with the Health Products Association, as its member, to enable the ASA to co-opt experts in the field of homeopathy and the prevention of symptoms of the flu.

In support of the efficacy claims, the respondent also submitted an evaluation report from Dr David Nye in support of its response. It pointed out that Dr Nye has been appointed by the ASA in the matter of Herbex Slimmers for Men / Dr H A Steinman / 879 as an arbitrator. A letter from the Health Products Association of South Africa was also submitted from which it should be clear that they regard Dr Nye as a credible expert in relation to the treatment of the symptoms of flu with homeopathic remedies.

Response from Dr Nye
Dr Nye submitted that he has prescribed Oscillococcinum to many patients for the prevention and treatment of flu symptoms and that many patients requested a supply regularly.

The first complainant appears to suggest that the advertiser has attempted to conceal the fact that the product is homeopathic by mentioning it only once in the commercial. There is nothing unethical or illegal about mentioning the word “homeopathic” only once.

The complainants concern that a dilution as high as the final product likely does not contain a single molecule of the original liver is in fact true. However, it must be pointed out that Newtonian physics should not be applied to explaining homeopathic medicine. An unidentified “Hypothesis to explain the process whereby Homeopathic Medicines are prepared” was submitted, and Dr Nye alleged that Quantum Physics is now an established science, and provides insight as to how homeopathy works.

In dealing with the suggestion that Oscillococcinum “may even pose a danger, as sick and vulnerable people will choose to forgo legitimate treatments in favour of this well-marketed sugar pill”, he pointed out that Oscillococcinum itself is devoid of adverse effects and the commercial clearly states “consult your doctor if symptoms persist”. It was added that Oscillocossinum can hardly pose a danger to forgo these “legitimate treatments” (such as bed rest, lots of fluid and anti-pyretics) as influenza is generally self-limiting.

Dr Nye made submissions relating largely to the following published papers:

Ferley JP, Zmirou D, D’Adhmar D, Balducci F. A controlled evaluation of a homeopathic preparation in the treatment of influenza-like syndrome. British Journal of Clinical Parmacology 1989; 27: 329-35;

Papp R, Schuback G, Beck E, et al. Oscillococcinum in patients with influenza-like syndromes. British Homeopathic Journal 1998; 87: 69-76;

Vickers AJ, Smith C. Homeopathic Oscillococcinum for preventing and treating influenza-like syndromes. Cochrane Database Syst Rev 3, 2006: CD001957. Doi:10.1002/14651858.CD001957.pub3. PMID 16855981

The papers that he evaluated will be dealt with in more detail on the ruling. However, he concluded that the evidence he reviewed supports the claim that Oscillococcinum is beneficial in the treatment of influenza and influenza-like symptoms, not the prevention of influenza. The commercial correctly states that it is a homeopathic preparation and states it ingredients and further cautions the user to seek medical advice if symptoms persist.

ASA DIRECTORATE RULING
The ASA Directorate considered the relevant documentation submitted by the respective parties.

ASA’s ability to interfere with the respondent’s right to trade
The argument appears to be that the Directorate cannot interfere with the respondent’s advertising simply because the respondent is awaiting MCC registration or otherwise.

This holds no water, and there is no provision in the Code which prevents the Directorate from performing its duties in relation to published advertising under such circumstances. In addition, in SolalTech Omega 3 & 6 / K Charleston / 16711 (7 October 2011) the Advertising Standards Committee (the ASC) similarly ruled as follows:

“The Appellant contends that its right to sell is restricted which is not correct. It is free to sell its products as it sees fit but it is not free to offer advice in its advertisements that contravene Appendix F. Like the MCC, as set out above, the Appellant is free to make submissions on amending the Code including Appendix F through the appropriate channels if it believes the Appendix serves no purpose in a self regulated environment”.

The same principle applies here, and the respondent, and its representative, ought to know that the Directorate does not purport to restrict an advertiser’s right to sell. The ASA’s jurisdiction is limited to advertising content only, and its decisions will relate to such material.

This argument is therefore irrelevant for the purposes of this ruling.

Registration in other countries and package insert
The respondent submitted that twenty different countries have registered the product as a homeopathic medicine and for specific therapeutic indication. The respondent submitted that these registrations and the therapeutic indications support the claims made in the advertisements.

Essential Medicine Monitor, a publication from the World Health Organisation, dated March 2010 states, “Homeopathy is used worldwide, however, the national regulatory framework and the place of homeopathy within the health care system differ from country to country”.

Given this and the fact that the South African Department of Health and the Medicines Controls Council have as yet to formalise a system for regulation and registration of homeopathic preparations, the Directorate does not accept that registration in another country qualifies as substantiating the claims with respect to the Code. Certain countries may accept registration under circumstances contradictory to the South African context and practice of homeopathy. In any event, the Directorate is not bound by registration in foreign countries and cannot rely on other countries’ acceptance of a homeopathic medicine as sufficient substantiation for claims made in advertising aimed at the South African market.

In a similar vein, it is unclear how, or why, the respondent believes that the packaging insert of a yet unregistered (and by implication unapproved) product would suffice as substantiation. The argument appears to be based on the fact that the MCC have not made any decision over whether or not the product should be registered or banned in the past 25 years, and as such the respondent, who has been selling the product in the interim, is entitled to keep doing so.

As explained above, the Directorate’s duty is detached from the respondent’s ability to sell the product or the MCC’s decision to register. Given that the package insert has, by implication, not yet been considered and approved by the MCC, there is nothing before the Directorate to show why this would suffice as substantiation for the respondent’s claims.

These arguments are therefore dismissed.

Co-option
The respondent submitted that the ASA should consult with the Health Products Association to seek experts to co-opt on the matter given its complex and novel nature. The Medicines Control Council and the Department of Health have indeed not formalised an approach to the regulation of homeopathic remedies, which makes the matter at hand complex and novel.

Clause 8.8 of the Procedural Guide reads as follows:

“Where, as a result of the complexity or novelty of the complaint, the Directorate cannot rule on the complaint without outside assistance, but where the urgency of the complaint nevertheless makes it impractical for the complaint to be referred to either the Advertising Standards Committee or Advertising Industry Tribunal, the Directorate shall be entitled to co-opt up to four persons, at its discretion, either drawn from the advertising industry or who have expertise in the subject matter of the complaint”.

While the MCC and the Department of Health have not formalised an approach on the registration of homeopathic preparations, the ASA is not called upon to qualify the legitimacy of the practice of homeopathy. The Directorate can still fulfil the ASA’s mandate to look at the content of advertising.

The issues at hand are certainly not “novel” as the Directorate and indeed the ASA has considered countless pieces of advertising for complementary medicines. Similarly, there is nothing “complex” in this matter beyond what the Directorate and the ASA have considered before; namely whether or not the respondent holds adequate substantiation in terms of Clause 4.1 of Section II of the Code for its efficacy claims. The Directorate is therefore satisfied that the submissions that have been made do not require that an expert be co-opted. The Directorate will be guided by the Code of Advertising Practice to judge the content of the advertising in question.

Legal actions against the respondent.
Both submissions from the complainants and the respondents included concerns relating to legal processes involving the advertiser and product before different international forums. While the Directorate has taken note of these, it should be emphasised that any such decisions or impending actions are not binding on the ASA. The Directorate has a duty to still apply its own mind to this issue and interpret the advertising, the submissions and the provisions of the Code accordingly.

Misleading claims
The letters of complaint objected to the misleading nature of the commercial based on the following grounds:

The word “homeopathy” was only mentioned once
The product may pose a danger as sick and vulnerable individuals may forgo other treatments in favour of the product.

The Directorate is satisfied that the reference to being a “homeopathic medicine …” is sufficiently clear and would not likely be missed by any person paying due attention to the commercial.

Secondly, it is not clear how or why the first complainant believes that people would forego their right to ask for medical assistance as a result of this commercial. While there is possibly room for such an argument in an instance where the advertising claims to cure a specific disease with significant consequence (such as, for example, claiming to treat or cure diabetes, AIDS, or cancer), this is not the case here and there is nothing in the commercial that discourages viewers from making use of any other treatment or advice.

Given the above, it is the Directorates view that this aspect is not misleading in terms of Clause 4.2.1 of Section II. This aspect of the complaint is dismissed.

Substantiation
Clause 4.1 of Section II of the Code states, “Before advertising is published, advertisers shall hold in their possession documentary evidence as set out in Clause 4.1, to support all claims, whether direct or implied, that are capable of objective substantiation.

The complainants are seeking substantiation for the claims: “Take Oscillococcinum immediately for relief of flu symptoms”, “Oscillococcinum is a clinically proven homeopathic medicine” and “Oscillococcinum is the proven solution and treatment of flu symptoms”.

While the Directorate agrees with the respondent that the commercial is not claiming to prevent people from getting the flu, it cannot overlook the overall communication and context.

The commercial shows a man and his daughter becoming infected with the flu as a result of catching the virus on the bus. When they leave the bus and take the respondent’s product, they appear to instantly be healed. Taking into consideration the fact that advertising has to exaggerate to some extent to get the relevant message across, the Directorate does not feel that this “healing” would be expected to be instantly.

However, the voice-over emphasises that this product should be taken “immediately” as it is a “clinically proven” treatment for flu symptoms. This attributes definite and material efficacy to the product. In other words, the implication is that any person who uses this product will, as a matter of fact, benefit from it in a manner that results in these symptoms disappearing fast. The question is therefore whether or not the respondent’s substantiation is adequate. Keeping in mind that general flu symptoms tend to pass on their own within a matter of days, the Directorate assumes that a hypothetical reasonable person would infer that the respondent’s product delivers effective improvement at a much more rapid pace.

Without commenting on whether or not Dr Nye is a suitable expert within the meaning of Clause 4.1 of Section II, the Directorate needs to point out the following:

In Lifebuoy / Dettol / 14813 (27 August 2011), the Advertising Industry Tribunal (the AIT) ruled as follows:

‘While we accept and indeed agree that because the Directorate (or any other ASA body for that matter) invariably may not or will not have the technical expertise to evaluate technical or scientific documentary evidence, it will often be required to rely, if not heavily, upon any expert views or opinions furnished, this does not mean that the Directorate may relinquish its responsibility to ensure that sufficient documentary substantiation in fact exists to any such expert. It is accordingly required, as would any other administrative body, or a court of law, in a similar position, to assess any expert view proffered and satisfy itself as to the adequacy, at the very least, of the expert view.

In the instant case we do not believe that the Directorate did properly satisfy itself of the adequacy of the expert view and in our view did not properly apply its mind to the question of whether sufficient and adequate substantiation had been put before it to support the claims in issue.

As we have noted, Dr Jardine’s expert opinion constituted a letter comprising one paragraph in which all that he says is that he has perused the research protocol, has applied his own knowledge and understanding to the matter and that it was his opinion that the claims are substantiated. No reasons for this conclusion are provided, there is no mention of the nature of the tests conducted in the research protocol, the date when they were carried out and by whom, what methodology was used or even the results of the tests. In truth all that we are told is that in his opinion the claims are substantiated. In effect the ‘opinion’ amounts to no more than a say so by Dr Jardine that the claims are substantiated.

In our view this does not constitute a reasoned expert opinion. Even assuming that the requirements of Clause 4.1.4 may be met by the furnishing alone of an expert opinion without a copy of the supporting substantiating documents, or at the very least sufficiently detailed summary of the studies / documentation being evaluated, (in respect of which we do not express any conclusive view) the one paragraph letter from Dr Jardine does not in our view constitute adequate expert opinion for the purposes of Clause 4.1.4.

Because it does not contain any explanation of the research methodology adopted nor any explanation of the basis / grounds upon which he concluded that the results of the study support the claims in issue, it was impossible for the Directorate or indeed anyone else, regardless of their expertise or lack thereof, to in fact satisfy themselves of the soundness of Dr Jardine’s conclusions. In the result, we are of the view that the Directorate misdirected itself in taking the view that the letter constituted sufficient substantiation for the purposes of Clause 4.1.4 of Section II of the Code’ …”

The implication of this is that the Directorate has to interrogate the substance of substantiation, and cannot simply accept the say-so of an expert, irrespective of whether or not such an expert has been accepted by the ASA before. While the Directorate accepts that Dr Nye’s opinion is substantially more reasoned than that of Dr Jardine in the Dettol matter referred to above, the Directorate could not overlook the following apparent discrepancies between what appears to be Dr Nye’s “unequivocal” verification, and the somewhat more ambivalent and qualified research it appears to be based on.

The Ferley, JP et al. study on which Dr Nye relies makes the following statement:

“Patients with an influenza-like syndrome who receive the homeopathic preparation showed a greater early recovery rate than those who received a placebo. This study sheds no light on the mode of action of this drug. Despite the use of terms such as attributable fraction which have specific meaning in clinical epidemiology parlance, IT WOULD BE UNWISE TO CLAIM THAT THE STUDY HAS DEMONSTRATED A CAUSE AND EFFECT RELATIONSHIP BETWEEN THE DRUG AND THE RECOVERIES. The positive effect of the homoeopathic preparation cannot be explained in our present state of knowledge, and thus calls for further investigation …” (our emphasis).

Although other shortcomings and potential concerns are highlighted in the article, they do not require replication at this time. The Directorate also notes that this article dates back to 1989, and it is unclear whether this could or should be regarded as “up to date and current” for the purposes of Clause 4.1 of Section II of the Code.

The Papp R et al. study, aside from finding that at 7-10 days after the start of the trial the differences in recovery between the treatment (verum) group and the placebo group were not statistically significant, included the statement that:

“The health of 12.6% of the patients of the verum group (16% of the placebo group) had not improved after 48% hours. Almost one third of the patients in the verum group took other medication during the trial. The fact that according to final assessment, 80% of the patients of the verum group (77 % of the placebo group) had recovered is not surprising since the disease lasts only 5-10 days even without medication …”

It is noted, however, that the study concludes that “… This clinical trial confirms the curative effects of Oscillococcinum …”

Here too the Directorate cannot ignore the fact that the study found no statistically significant difference between the recovery groups, or the fact that this study dates back to 1998, which again presents the question of whether or not this is sufficiently up to date and current for the purposes of Clause 4.1 of Section II. Neither Dr Nye nor the respondent deals with this question.

In the Cochrane Collaboration study, the author concludes as follows:

“Oscillococcinum appears to have a moderate effect in the treatment of influenza and influenza-like syndrome” and “Confirmatory trials of Oscillococcinum are warranted. The main difficulty of such trials will be the requirement for a large sample size. Oscillococcinum is inexpensive (approximately $ 5 US per influenza episode), easy to take and apparently very safe. It is worth taking Oscillococcinum even if it is of only very moderate benefit. At a population level, there would be significant gains from even five percent reduction in the length of influenza episodes. However, detecting such moderate but worthwhile benefits would require large sample sizes.”

However the study concluded, “Oscillococcinum appears to have a moderate effect in the treatment of influenza and influenza-like syndrome”.

Dr Nye’s evaluation is silent on the concerns raised in each of the studies regarding further investigation, statistical significance, or relevancy. It is unclear as to whether the evaluation only considered the elements that confirm the claims and not the elements that do not, or that the elements that do not confirm the claims are not relevant to the substantiation of the claims. However, the fact that the studies have all raised concerns is an element that cannot be ignored.

It is the opinion of the Directorate that there is somewhat of a gap between the findings of the studies and those of the expert used. This gap is not explained by any of the submissions at hand, and the Directorate cannot, in accordance with the principle established in the Dettol matter, turn a blind eye to this. Given that the research relied on does not create the same implication or expectation of a definitive, material and accelerated improvement, the claims, in the context in which they are made in the commercial, are currently unsubstantiated.

Given this, it is the Directorates view that the advertising is in breach of Clause 4.1 of Section II.

Based on the above, the respondent is required to:

Withdraw the television commercial complained of;

Action the withdrawal of the commercial with immediate effect upon receipt of this ruling;

Ensure that the commercial is withdrawn within the deadlines stipulated in Clause 15.3 of the Procedural Guide; and

Not use the commercial in the current format again in the future.

The complaints are upheld.

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