Absurdity of Oscillococcinum: ASA FAC ruling

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Posted 19 September 2012

This is a story of money, of failure of appropriate interpretation of evidence, of a legal process trumping facts. This is a story of consumers being screwed.

This is not a story of whether homeopathy works or does not work – it is about whether evidence and proof is less strong than personal opinion, and of whether “experts” can be believed or even trusted.

This is a story of whether a “belief” should be superseded by the accumulation of evidence and facts that contradicts that belief, and how strongly a commercial company will fight back to keep making money even if the product is actually useless.

 

What is Oscillococcinum?

Oscillococcinum is a homeopathic alternative “medicine” marketed to relieve influenza-like symptoms. The preparation is derived from duck liver and heart, diluted to “200C” – a ratio of one part duck offal to 100200 parts water (which is a 1 followed by 400 zeroes). This is such a high dilution that the final product likely contains not a single molecule of the original liver. Homeopaths claim that the molecules leave an “imprint” in the dilution that causes a healing effect on the body. This article won’t discuss whether the belief is possible, or absolutely ridiculous.

Wikipedia has a good overview of the product.

HomeoWatch has an excellent overview of “The True Story of Oscillococcinum”.

 

The essence of the complaint to the Advertising Standards Authority was this:

The television advert for this product made a claim that this product was effective for colds with the clear impression that most if not all users of the product will benefit.

 

The ASA agreed with the complainants that there was insufficient proof that the product has any efficacy and ruled in favour of the complainants. In fact the ASA evaluated the evidence submitted by Dr David Nye, a homeopath and the “expert” substantiating the product on behalf of the company in favour of the claims of the product, and dismissed his substantiation seeing very clearly that the evidence was insufficient.

However the company appealed the decision, and the appeal committee (comprising non ASA staff), without examining the argument of the complainants, sided with the company and ruled in their favour by simply accepting that the company’s expert, Dr Nye, was an “expert” in homeopathy and therefore his testimony is factual and correct.

The consumers appealed and the case came before Judge King who also ruled in favour of the company dismissing the appeal based largely on the fact that the company had not had a chance to examine the counter argument (evidence) provided by the consumers.

 

In other words, the company’s own “facts” and Dr Nye’s substantiation was not compared with the counter argument which in fact showed that Dr Nye’s interpretation of the science was blatantly wrong (incompetence? deliberate?) and that the product is in fact useless.

Here are the facts (not assessed by Judge King):

  • The company’s own statistician agreed with the consumer’s argument that only 7 out of 100 will benefit from using this product. And as had previously been pointed out, may benefit only by a few hours (the range being 1.5 to 12 hours).
  • Dr Nye misrepresented the Cochrane report (confirmed by the author or the Cochrane Report).

 

The Cochrane Report is a form of evaluating all the evidence around a particular claim or product. It is regarded as the highest level evidence for or against a product. Dr Nye accepts that the Cochrane Report is a “Gold Standard” and therefore that the evidence from this report should be believed.

Dr Nye wrote: “[T]he Cochrane Review is instructive as it covers all the trials carried out on Oscillococcinum like products. Extract from the author’s conclusions of Cochrane review state: ‘However the company did not mention the preceding sentence “Oscillococcinum is inexpensive, 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 social gains from even a five per cent reduction in the length of influenza episodes

This was NOT my interpretation of the report and I wrote to the author of the report, Dr Vickers, to ask whether this is the correct interpretation. NO was his response – the evidence for Oscillococcinum is that it does not work – at best it appears to have some benefit in around 7 out of 100 people and then the benefit is in the range of 1.5 to 12 hours. Dr Vickers pointed out that the last part of the above paragraph was completely out of context.

Dr Vickers wrote: “I did not say ‘Oscillococcinum has moderate benefits; it would be worth taking if it had moderate benefits; therefore take it’. What I said was “it would be worth taking if it had moderate benefits; to detect moderate benefits you need very large sample sizes; more research is needed with very large sample sizes”.

In other words, to conclude, for 93 people using this product, NO benefit can be expected.

Dr Nye claims to be getting great results from using this product – which seems to be in direct contradiction to a summary of all the studies on this product. His misinterpretation of the actual conclusions of the Cochrane Report leads to a potential hoodwinking of ordinary consumers like you and I.

On the Health Products Association’s (HPA) newsletter, titled “CAMS VICTORY”, the following is stated: “We beat the complaint based on the merits of our substantiation and the paradigm of homeopathy,” concludes [Vernon] Bartlett. “We are obviously thrilled, not only for Oscillococcinum, but also because we have secured a landmark victory for CAMS.”

What incredible bull!

Don’t believe me?

Here are the actual documents.

  • The company’s, and Dr Nye’s claim that the product works based on inter, alia the Cochrane Report
  • The consumer’s argument showing that the product does not work, supported by the author of the Cochrane Report
  • The company’s “heads of argument” before Judge King
  • Judge King (Final Appeal Committee of the ASA) ruling

 

[accordion][spoiler title=”Judge King’s FAC ruling” style=”fancy”]

BEFORE THE FINAL APPEAL COMMITTEE OF THE ADVERTISING STANDARDS
AUTHORITY OF SOUTH AFRICA (FAC)
Ref: 18385
In the appeal of the ruling of the Advertising Standards Committee of 1 June 2012 in the
matter referenced OSCILLOCOCCINUM / Z JOUBERT & ANOTHER /18385:
DR HARRIS STEINMAN: Appellant
And
BOIRON LABORATORIES: First Respondent
GLENMARK (PTY) LTD: Second Respondent

FINAL APPEAL COMMITTEE RULING

1. In July 203.1 the Respondent flighted a television commercial promoting the product
Oscillococcinum. 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 turn slightly more red in the face. The voice over states: “When the 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 puts on the emergency brake and the two of them are transported home
where they each take a dose of the advertised product, in the commercial it is stated: “Consult
your doctor if symptoms persist.” The overall takeout of the commercial is that
Oscillococcinum, a homeopathic product, could relieve flu symptoms but if it does not you
should consult your doctor.

2. There were two complaints about the advertisement. One by an Advocate Zach Joubert
and the other by a Dr H Steinman. The gist of their complaints was that there was no evidence
to support the claim that Oscillococcinum could relieve flu like symptoms, it was also pointed
out that there had been no approval of the product from the body entrusted to assess the
safety, quality and efficacy of medicines.

3. In response to these complaints the Respondents, inter alia, filed an evaluation from a Dr
David Nye. It was contended that Dr Nye was an independent and credible expert in the
context of Clause 4 of Section 11 of the Code, particularly in the field of homeopathy and
natural medicine. Dr Nye has two internationally accredited post-graduate qualifications in
homeopathy, is an experienced lecturer on the principles and practices of homeopathy to
medical doctors, has been in general practice for the last thirty years and has treated the
symptoms of flu in numerous cases. As a homeopath Dr Nye has prescribed Oscillococcinum
to many patients for the treatment of flu symptoms with excellent results. Dr Nye has both
theoretical knowledge and actual experience of the matters on which he testified.

4. Dr Nye pointed out that Oscillococcinum has been evaluated in several random controlled
trials and that peer reviewed evidence supports the claim that Oscillococcinum is beneficial in
the treatment of flu-like symptoms. The Respondents consequently claimed that they had
substantiation for their claims in terms of Clause 4.2.1 of Section II of the Code, and that
consequently their claims were not misleading.

5. The Directorate found that Dr Nye’s evidence did not go far enough to satisfy the tests set
out in the ruling of Lifebouy/Dettol of 27 August 2011 which in short laid down that the
Directorate had to apply its mind to the expert evidence tendered for substantiation to ensure
that it was properly motivated and that the conclusion was a reasonable one based on the
motivation. The Directorate concluded that the verification relied on by Dr Nye was not
unequivocal and that there was somewhat of a gap between the findings of the studies
tendered by the Respondents and those of Dr Nye. The Directorate consequently ruled that
the Respondents had not established substantiation as required by the Code and that the
commercial was in breach of the Code. Based on that the Directorate required the
Respondents to withdraw the television commercial.

6. The Respondents appealed to the Advertising Standards Committee (ASC) against the
Directorate’s ruling and both Advocate Joubert and Dr Steinman opposed the Respondents’
appeal against the Directorate’s ruling. In its appeal to the ASC, the Respondents filed a
further evaluation by Dr Nye. The two complainants contended, inter alia, that the further
evaluation should not be considered as it constituted new evidence on appeal before the ASC.
The ASC accepted the additional evaluation in terms of Clause 4.1.7 of Section If of the Code
as being new substantiation after a ruling had been made by the Directorate. The latter had
not ruled on the additional substantiation which formed part of the appeal. The ASC acting in
terms of clause 9.10 of the Procedural Guide ruled on this additional substantiation.

7. The ASC concluded that the present case was distinguishable from the Dettol matter in that
Or Nye had provided a professional and reasoned opinion on the efficacy of Oscillococcinum
in the treatment of flu-like symptoms. The ASC accordingly upheld the appeal and set aside
the Directorate’s ruling, finding that the Respondent had established substantiation of their
claims in terms of the Code. It must be remembered that the ASA Code provides for a prima
facie procedure in terms of Clause 4.1 of Section 11, given that the Directorate or any
committee of the ASA could never have the expertise in all the particular fields of advertising
to enable them to determine whether the person validating the claims at issue is independent,
credible and an expert in the particular field.

8. The complainant, Dr Steinman, filed an appeal against the ASC’s ruling to the Final Appeal
Committee (FAC). Advocate Joubert did not file an appeal to the FAC. Dr Steinman
contended that Dr Nye was not an expert on science, scientific analysis or scientific
deconstruction. He also argued that Dr Nye had misinterpreted the clinical importance of two
studies dealt with in his notice of appeal.

9. In the Respondents’ reply to the Appellant’s Notice of Appeal they pointed out that Dr Nye
holds an M.F. Horn. (UK) diploma qualification which he obtained in 2001, is registered with
the Allied Health Professions Council as a Homeopath in South Africa, besides being a
registered Medical Practitioner. His opinions are based on direct observation of patients and
he is a highly trained observer subject to peer review by his professional council, In support of
this the Respondents filed a further affidavit by Dr Nye in which he deals with certain studies
on Oscillococcinum and the rebuttals dealt with by the Appellant in his Notice of Appeal. He
concluded that all the studies demonstrated that Oscillococcinum does have a beneficial
effect in the treatment of symptoms of flu. He quoted from the so-called “Coccinum Review”:
“It is worth taking Oscillococcinum even if it is of only very moderate benefit. At a population
level there would be significant social gains from even a 5% reduction in the length of
influenza episodes.”

10. On Sunday 22 July 2012 Dr Steinman mailed further argument and evidence in which,
inter alia, he attacked the credibility of Dr Nye. This was new ground and one that had not
been explored before the Directorate or the ASC. The Respondents did not have adequate
opportunity to deal with it and Dr Steinman did not promote any reasons why his late
submissions should be accepted by the FAC. Not only did he not do so to his mail of 22 July
2012, but he did not appear before the FAC to argue his appeal.

11. Mr G Malindi SC, on behalf of the Respondents, argued that the Health Products
Association of South Africa had now submitted a draft Code for the regulation of
Complementary and Alternative medicines (CAMS) which would be considered at the next
Annual General Meeting of the ASA and that I should exercise my discretion under clause
12.19 of the Procedural Guide to postpone the hearing of the Appeal until the Appendix on
CAMS was approved at the AGM. He was unable to advise the Committee from the Bar over
how many years the HPA has attempted to create an Appendix on CAMS and whether
anyone could be assured that the draft Code would be accepted at the AGM in the terms set
out in his heads of argument. The exercise of a discretion has to be done judicially and facts
are needed on which to base such a judicial discretion. There was nothing before me which
could guide me in exercising the requested discretion. In consequence I cannot accede to this
request.

12. Secondly Mr Malindi argued that the Appellant’s case had been brought in the wrong
forum because substantially he was arguing expert scientific evidence which was a matter for
arbitration and not appeal. The Appellant was using the appeal process as an arbitration and
was thus abusing the appeal process. In this regard the Appellant had the right to either elect
to go on appeal or to request arbitration. He elected the former. Accepting for the purposes of
argument that the Appellant’s grounds of appeal are more suited to the arbitral process in the
Code this only goes to the weight and quality of his grounds of appeal. We do not agree that it
is an abuse justifying dismissal of the appeal.

13. On the merits Mr Malindi argued that consumers are familiar with the symptoms of flu and
that a consumer would clearly understand the commercial to mean that it was limited to the
relief of flu symptoms and clearly implied that if it did not work, the consumer should consult
his or her doctor. The implication in the advertisement was that it would not relieve a
consumer of flu symptoms in every case. The Appellant in his new evidence, which could not
be heard by this Committee for the reasons set out above, concluded that “If the advertising of
Oscillococcinum were to be not misleading, it would have to state that by taking
Oscillococcinum, about seven out of every 100 people would benefit and will experience relief
of their symptoms about 6 times more rapidly than if they had taken nothing at all.” There is
nothing to indicate a claim of percentages by the Respondents and Dr Nye’s evidence is a
sufficient substantiation that Oscillococcinum will in some cases relieve flu symptoms.

14. We have consequently concluded that the ASC was correct in accepting the
substantiation proffered by the Respondents in the form of the testimony of Dr Nye as a
credible and independent expert in the field of homeopathy.

15. In all the circumstance the appeal of Dr Steinman cannot succeed and is dismissed.

16. There will be no order as to costs as the Respondents did not seek any order as to costs.

Mervyn E.King S.C. President
Date 30/07/2012 [/spoiler] [/accordion]

 

———————————-

HPA Newsletter text

CAMS VICTORYIt was a triumphant moment for South Africa’s spokesperson of the Boiron product Oscillococcinum, Vernon Bartlett, when the distributor’s appeal against a complaint lodged with the Advertising Standards Authority (ASA) was successful. The ruling also represented a significant victory for CAMS, as the health products industry has for years been plagued by an inordinate number of complaints lodged with the ASA by a small group of activists with an aversion to the CAMS industry.“The endorsement of a right-to-advertise supported claims for a tried and tested product like Oscillococcinum – falling under a legitimate paradigm such as homeopathy – is long overdue,” states Bartlett. “We believe a necessary precedent has been set and like to think it contributes importantly to the debate on appropriate and relevant control of CAMS, for which the HPA has long been campaigning. Hopefully it will also help encourage sensible reflection on the free-for-all that has developed in place of this control.”Complaints were lodged by Dr Harris Steinman against a Boiron laboratories television commercial promoting the product Oscillococcinum. Reference was also made to claims appearing on the www.lebron.co.za website, among others. Stefan Vos Marketing Regulation Advisers acted on behalf of the respondents and in support of the efficacy claims, while the respondents also submitted an evaluation report by Dr David Nye.“It is so easy for some individuals or companies to exploit the current situation with regard to suspect products and claims, and vigilance is therefore absolutely necessary,” continues Bartlett. “Sadly, it has similarly become commonplace for some with their own agendas to use available platforms to attack not only worthy products, but often also their recognised disciplines. Unfortunately, in all of this the rights of the consumer are too often compromised.”“We beat the complaint based on the merits of our substantiation and the paradigm of homeopathy,” concludes Bartlett. “We are obviously thrilled, not only for Oscillococcinum, but also because we have secured a landmark victory for CAMS.”
[note note_color="#f6fdde" radius="4"]CamCheck posts related to Oscillococcinum
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