Boiron is the world’s largest manufacturer of homeopathic products. The 2016 sales figures of the company amounted to 614 489 000 Euro. Boiron has recently been very active promoting its products, not least on Twitter where I note about 10 of their promotional tweets every day. I saw the following tweet yesterday:
Acidil temporarily relieves occasional heartburn, acid indigestion, bloating or upset stomach. (link: http://bit.ly/2gCARdu)
This prompted me to look up what this product contains. The ingredients (potencies) are as follows:
- Abies nigra (4C)
- Carbo vegetablilis (4C)
- Nux vomica (4C)
- Robinia pseudoacacia (4C)
Just to remind you, 4C means the substance is diluted at a rate of 1: 100 000 000. Even the most deadly poison would be ineffective at such a dilution.
So, how can they claim that it is effective?
To find the answer, I did a Medline search and found the only listed trial of Acidil (if anyone knows of further studies, please let me know). Here is its abstract:
BACKGROUND:
It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM) are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD) is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.
METHODS:
24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1) either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2) either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.
RESULTS:
There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41), however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01). Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.
CONCLUSION:
An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this visit-based intervention are warranted.
The question I have is simple: why are they allowed to make false medical claims?
Is there anyone out there who can answer it?
12 Responses to Boiron: why are they allowed to make false claims?
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The tweets come from the US arm of Boiron and they aren’t allowed to make false advertising claims. It’s more a case of US consumer protection being really weak and the only effective recourse being via the Courts.
Boiron have been the subject of class actions in the US and Canada.
It’s interesting to note that Boiron doesn’t have a UK presence.
and what about the claims printed on the US packaging?
Here are the requirements – http://www.hpus.com/Revised-Labeling-Guidelines-04-14.pdf
It’s the Federal Trade Commission that deals with marketing claims for OTC products in the US – and that would include indications. The rule of thumb is that if the manufacturer can supply two “scientific trials” showing efficacy, indications are permitted (yes, it’s that weak). However, certain indications would not be permitted by either the FDA or the Homoeopathic Pharmacopoeia Convention of the United States – products would be prescription only. Asthma is a good example of where this is widely ignored. If a product is prescription only, FDA deal with marketing claims.
US regulation is a total mess.
thanks for this concise explanation.
however, I fail to see that they have 2 scientific trials for the claims on the package.
It only comes into play when FTC deign to get involved. Case of FTC v. Wright, et al. (“HCG Platinum”) is illuminating. This statement https://www.ftc.gov/system/files/documents/cases/141211hcgramirezstatement.pdf spells it out.
I should mention that I was involved in bringing homeopathic hCG to the attention of FDA and FTC.
Would these count (not to you, to the FTC and Boiron)
Placebo vs. not double blinded remedy.
Nothing vs. remedy/intervention.
Combinations of the above.
Surveys of users just asking if they thought it worked…
Very small studies with a liberal interpretation of significance.
Obviously there are hundreds (thousands?) of such studies of homeopathy out there, as homeopaths cite them all the time!
The most hilarious claims include “temporarily relieves occasional” [names of symptoms]. So does custard.
Not forgetting “dissolve 2 tablets under the tongue every 15 minutes for 1 hour”. I guess if it were potentized to 30C this would read “Take one tablet every week”.
Then there’s “Store at 68-77°F (20-25°C)”. So the product is not much use outside the Tropics and the USA, where homes are regularly heated above 20 °C.
I live in France and this company makes the same sort of claims in their television advertising for lots of it’s products even though there are regulations on advertising. As for why they’re allowed to make false advertising claims, the answer is quite simple: it’s because they can and they get away with it and make a fortune doing it.
Homeopathy is ‘accepted’ in France and promoted widely even by pharmacists (and their shop assistants) and of course make Boiron a fortune.
living half of my time in France, I can only confirm this.
Well EU Directive 2001/83/EC does permit EEA member states to set up a scheme to register homeopathic medicines with indications. Where member states vary is in the evidence base required for those claims. L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) obviously has very lax requirements.
Has L’ARPP made any rulings on homeopathy?
Thankfully living in a EU-state without any more than the most basic inclusion of homeopathy in the medicinal product laws – no indication, no dosage, no use advice, nothing less “potentiated” than D4 (or more for certain products), nothing but oral or topical administration… And none of the pharmacy chains stocking the products! Go Sweden!
“Why are they allowed to make false claims?”
Who would stop them?
Not governments because:
(a) The Mao Gambit – it is better for a government to have some care available for its population than none.
(b) Government (and the regulators they appoint) are not interested in ‘Truth’ – just listen to ’em.
They are content to have an industry develop which employs folks (manufacturers, pharmacists, practitioners).
(c) They are delighted with the VAT returns to government’s coffers.
(d) No doubt lobbying goes on – some of it may not be appropriate (making false claims is not, for a start).
It’s called ‘vested interests’.