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IT’S not often you see a homeopathy manufacturer in trouble for including an actual therapeutic ingredient in their product, but that’s what happened in the US recently.
A company called Terra Medica last month voluntarily recalled 56 products in its Pleo range after the Food and Drug Administration determined they could contain penicillin or its derivatives.
The products had been marketed for the treatment of a range of bacterial infections, with the claim they did not contain antibiotics and would therefore not cause side effects “such as allergies, liver damage, destruction of the intestinal flora and the formation of penicillin-resistant strains”.
The withdrawn products included the Pleo-Not, Pleo-Quent and Pleo-Fort ranges.
Pleo-Fort would, I suppose, be a stronger preparation than the others, which would mean a weaker one — one of the principles of homeopathy is that the more you dilute something the stronger it becomes, so perhaps “Fort” actually means weaker, which means stronger, which … all right, I’m confused.
In any case, saying something doesn’t contain antibiotics when it does is no laughing matter since, as the FDA pointed out, even low-level exposure could be potentially life-threatening for some people with an allergy to the drugs.
It’s not the first time a homeopathic manufacturer has been in trouble with the FDA.
A 2012 warning letter to a UK manufacturer would be hilarious if it didn’t raise serious quality concerns.
The company had failed to implement measures to prevent contamination of its products with broken glass, despite a recurring problem with glass vials breaking on the production line. It also didn’t appear particularly rigorous about ensuring the so-called active ingredients in its homeopathic products were being consistently included.
In relation to one batch, an FDA investigator observed “one out of every six bottles did not receive the dose of active homeopathic drug solution due to the wobbling and vibration of the bottle assembly … The active ingredient was instead seen dripping down the outside of the vial assembly”.
The letter also raised concerns about variable amounts of the active ingredient in pillules, with those “at the top of the bottle contain[ing] more active ingredient than pillules at the bottom”.
Well, all I can say is it’s lucky those homeopathic ingredients don’t actually appear to do anything, as the NHMRC’s long-awaited draft information paper on evidence for homeopathy made clear last week.
After examining evidence for homeopathy’s effects in 61 different health conditions, from asthma to migraine, the NHMRC concluded there was no reliable evidence of benefit in any of them.
“No good-quality, well-designed studies with enough participants for a meaningful result reported either that homeopathy caused greater health improvements than a substance with no effect on the health condition (placebo), or that homeopathy caused health improvements equal to those of another treatment”, the paper says.
None of that is going to convince the true believers, of course. The Australian Homeopathic Association’s Ana Lamaro responded last week, in an interview on ABC Radio National in which she suggested the NHMRC process, with its reliance on systematic reviews, was unfair to homeopathy.
“Evidence is a bit like beauty — it’s in the eye of the beholder”, she said in another interview published in the Sunshine Coast Daily.
The findings probably won’t reduce Australians’ spending on homeopathic products either — estimated at US$7.3 million a year, according to the NHMRC — though you might hope they’d influence the 8.5% of rural and regional NSW GPs found to have made repeated referrals for homeopathy in a 2013 study.
They are likely to have an impact on the federal government’s review of private health insurance rebates for alternative therapies — and so they should, given that the rebates are, in effect, a government subsidy.
For the last word on homeopathy, if you haven’t already seen this Mitchell and Webb skit set in a homeopathic emergency department, it is worth watching.
Jane McCredie is a Sydney-based science and medicine writer.
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Readers might be interested to know that Nancy Malik is a ”homeopathic doctor”, trained (according to her on-line information) at ”Homoeopathic Medical College and Hospital’’, Chandigarh, India. She runs a blog where she promotes homeopathy as ”science-based”. It is possible that the responses to the two polls listed as being on her website might be subject to section bias.
There are two more polls on homeopathy.
Poll 1: Should pharmaceutical drug treatments be publicly funded by the NHS UK? http://drnancymalik.wordpress.com/2012/06/05/poll-2/ Poll2: Poll: Which form of medicine would you prefer to use? http://drnancymalik.wordpress.com/2012/06/04/polls/ The poll closes on 28th April 2014.
One does, however, have to be amused by those product names: ”Pleo-Not, Pleo-Quent and Pleo-Fort”. The profix ”pleo” (derived from Greek) means ”more”. “Quent” appears to be a sciency-sounding neologism, while ”fort” is a contraction of ”forte”, meaning ”strong”. And ”not”, I presume, carries its standard meaning. Can’t you just imagine a few twenty-something marketing graduates around the table throwing in these names?
Dr Joe – how do we know that Tamiflu is less effective than first thought? Because the medical profession assesses efficacy, analyses data and reviews its position. But homeopathy? No review of the principles expounded by a nineteenth century German guy. No glass houses there.
Homeopathy doesnt work.It is easy to be triumphalist anout this until we remeber that Tamiflu doesnt work either. And billions of dollars have been wasted.Increasingly as a profession we need to be very careful about glass houses.
Thanks for the article, Jane. The issues with homeopathy are multiple – beyond lack of evidence of efficacy (beyond placebo) to its very plausibility (we would have to re-invent physics and chemistry for it to be plausible). Then there are the consumer issues and truth-in-labelling – how would you know whether that little bottle no longer contained a single molecule of Nat Mur, or whether it no longer contains Nux vomica? And why spend around $900 per litre for what essentially contains brabdy and/or water. The whole world has moved on from when Samual Hahnemann came up with the model of similars, and of dilution, at a time when conventional medicine was using blood-letting. I suspect Hahnemann would now be turning in his grave, watching people still cling to his old theories, while chatting about it on their smartphones. Cognitive dissonance indeed.
I’m embarrassed to say it only just occurred to me, at the time of the most recent hike in my private health insurance premium, that I was paying indirectly for other members to access non-evidence based alternative treatments, including, of course, homeopathy. Meanwhile I can only claim $400 a year for my son’s speech therapy when the annual bill comes to around $5000. Forget consumer choice – alternative practitioners should be required to present good quality evidence of efficacy before their chosen modality becomes rebatable through private health insurance.