Last night’s Four Corners program may have focused on the American experience, but Australians should not assume that different, tighter regulations here mean that complementary medicines are all evidence-based, say industry commentators.
And pharmacists, as medicines experts, should be helping consumers understand the evidence base.
Friends of Science in Medicine’s Ken Harvey told the AJP today that many consumers do not understand what the AUST L and AUST R numbers on complementary medicines actually mean.
All complementary medicines legally available for sale in Australia must be included on the TGA’s publicly accessible database, the Australian Register of Therapeutic Goods. The TGA conducts a safety assessment on ingredients in Listed CMs (AUST L number), which most CMs are.
“There’s a few registered CMs, and some are grandfathered (which is ridiculous) but a couple of evidence-based ones are registered; the problem is that while we would encourage that, sponsors don’t bother to go through registration,” Dr Harvey says.
“Clearly the listing doesn’t protect consumers – most complementary medicines have an AUST L number which means nobody’s looked at it to see if it works, and people don’t understand that there are high levels of non-compliance.
“This is what you’d expect from a trust-based system with no real penalties.”
He said that of 330 post-marketing reviews of listed complementary medicines undertaken by the TGA between January 2015 and February 2016, the TGA found that of 208 random reviews, 66% were non-compliant; of the 122 targeted reviews, 87% were non-compliant.
Of the targeted reviews, 82 originated as a “complaint or referral”.
Taree pharmacist and Friends of Science in Medicine member Ian Carr told the AJP that efficacy aside, the Australian system is genuinely tighter than the American.
“However, if you look at the press reports I’ve seen in recent months and years, we’ve seen products slipping through that are adulterated, stories coming up of say, fish oil that doesn’t contain the stated amount and so on.
“So I would like personally to see the system tightened further.
“With AUST L, the principle that they work on is that a particular substance is assumed to be safe; but at the same time we’ve seen, especially with herbs, that this isn’t always the case; there have been issues around liver toxicity with a herbal menopause treatment.”
One of the commentators interviewed during the Four Corners story said that people can increase their risk of certain illnesses by taking megavitamins.
Carr says that it’s hard to quantify whether taking supplements has a beneficial effect on an individual over time, simply because people stop taking them as trends change, new products become available and people swap between brands.
“If you don’t have a good body of unbiased clinical trials behind you, then you really have a very vague view of what the endpoint of your experiment on yourself is, other than ‘wellbeing’ or ‘more energy’ and these are likely to be placebo effects from your treatment anyway,” he says.
Dr Harvey says that people would need to take very large amounts of vitamins to actually harm themselves, but that this could happen, partly due to a belief among consumers that CMs, being “natural,” carry little or no risk.
“You’ve got to take a lot before they’re actively harmful,” he says. “But given some products contain more than the daily requirements, and that people double and triple up, it’s a possibility.
“There’s this idea perpetuated by advertisers that if you don’t eat enough fruit and vegetables, you can pop a multivitamin and you’ll be right.
“That’s not true. Supplements are no substitute for fruit and vegetables and all the evidence shows isolated ingredients are not a substitute for a proper amount of oily fish in the diet, for example. There’s this myth perpetuated in advertising that if you’ve a busy lifestyle or you’re stressed, just pop a multivitamin.”
He says that some supplements are evidence-based, such as folic acid in pregnancy and vitamin D/calcium for seniors in nursing homes, and that it’s valid for pharmacy to stock these. However, he expressed concerns about encouraging consumers to self-select without talking to a pharmacist.
“I’d like to see pharmacists put up a huge sign over their natural therapy products, saying ‘these products have not been evaluated by the Australian health authorities to see if they work; they can interact with prescription and OTC medicines; before you purchase any, talk to your pharmacist’.
“As for naturopathy in pharmacy, to me that’s scraping the bottom of the barrel and pharmacists are just abdicating their responsibilities by putting a naturopath in there.
“Pharmacists are the experts in medicines; they’re pretty good at prescription and OTC medicines and they should be equally good at complementary – they just need training and a proper database, and be able to give advice.
“Naturopathy is not a regulated profession. There’s good ones – you can have a four-year uni course to be a naturopath and not be too bad, though the associations still talk about stuff like homeopathy – but a lot in practice end up pushing detox products and the like.
“There’s no reason pharmacists can’t be reasonably expert in complementary medicines and get people to talk to them. They mightn’t sell as much, but they would be more respected.”