Jane McCredie: Dilute evidence

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The withdrawn products included the Pleo-Not, Pleo-Quent and Pleo-Fort ranges.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.