Hard News by Russell Brown


An unexpectedly long post about supplements and stuff

I called The Listener with a message for Mr Matt Nippert yesterday. The gist of the message - nay, its entirety - was "Hahahahaha - you're on The Panel with Christine Rankin today". In the event, Matt kept his composure admirably, even when she enthused about how there must be something in astrology because it had, y'know, mathematics in it.

I wonder if Mrs Rankin is still engaged with her chant-for-a-new-BMW middle-class Buddhist cult? (More extensive profile here.)

She's on another mission now though: a crusade against the Therapeutic Products and Medicines Bill, which is at select committee. It enables a joint agreement with Australia on regulation of supplements, natural and alternative medicines.

She shared with us the remarkable factoid that there was only one recorded death from natural remedies - and that was when someone got a pill stuck in their throat and choked! Who knew!?

Rankin declared that she was teaming up with Allison Roe to fight the bill with all her might. As Allison had told her, she said, if our athletes couldn't get their supplements, how would they win gold medals any more?

Allison Roe is an amazing athlete, but I don't think that's why she's taken up arms against the bill. That would more likely be something to do with her involvement with a vedic medicine business for which she supplies a tailored fitness programme that draws on her own expertise plus "timeless knowledge from Maharishi Vedic Medicine." And the products for sale are not cheap. She has an obvious interest.

Indeed, when I sat down yesterday to try and work out what I thought about all this, I discovered that it was quite hard to find an advocate who wasn't either directly commercially interested, or insane.

(They're there, of course. This non-conflicted, non-insane submission on the bill from the New Zealand Organisation for Rare Disorders is one good example.)

Oddly these are some of the same people who scream bloody murder about big-business influence on regulation and want food origins certified all the way back to whatever foreign field from which it hailed. But they want traditional remedies from some other foreign field waved through on trust. Go figure.

Often that's because they're traditional and have been "used for thousands of years".

That's such a shitty argument.

Look at black cohosh, a time-honoured remedy for menopause symptoms - except there's no good evidence that it works, and growing evidence that it can cause liver damage (but lots of people will happily sell it to you in New Zealand.)

Or take sassafras, a revered tonic whose active ingredient, safrole -- once commonly used as an additive in sassafras tea, root beers and the like -- is now known to be somewhat carcinogenic. You can't even use it in soap these days. (Although it is still just the ticket for making Ecstasy.)

Beta-Carotene: a dietary essential, therefore it must be good for you, right? Actually, it turns out that if you're a smoker, taking beta-carotene supplements increases your risk of lung cancer.

This now rather old FDA article has many more zingers, including:

- Germanium: Use of this nonessential element for a long time may cause serious, irreversible kidney damage and has resulted in death. Germanium products are promoted as so-called "health promoting" elixirs or as an "electronutrient" for uses such as neutralizing heavy metal toxicity. There is no evidence of effectiveness.

- Jin Bu Huan: Unapproved labeling claims this Chinese herbal product is useful for relieving pain. After accidentally taking Jin Bu Huan, three preschool children were hospitalized this year in Colorado with life-threatening, very slow heart rates, depressed central nervous systems, and breathing difficulties. After intensive medical care, the children recovered.

In many such cases, the problem is over- or inconsistent dosage. Yet one of the complaints of the bill's opponents is that the potency of some vitamin and mineral supplements will be reduced.

What I find odd is the through-the-looking-glass approach to consumer rights the pro-supplement lobby seems to hold. As a consumer, I might regard it as my right to be protected from poor products and shonky manufacturers. It seems to make sense that someone selling me something I'm going to put into my body should have to demonstrate that it, within reasonable bounds, safe.

The "health freedom" people work it the other way. The authorities should have to prove something isn't safe before you're not allowed to buy it. Check this guy treating the US Food and Drug Administration's recently-won right to assess supplements using a risk/benefit principle like that applied to conventional medicine as if it's the final assault on liberty. Take this part:

The recent Supreme Court case involves the herb Ephedra, wherein a high dose may have adverse cardiovascular side effects. However, there is no evidence that lower doses cause any harm at all. The herb has been in traditional use for several thousand years. The FDA has no proof that it poses any harm whatsoever in smaller amounts. By using drug-related risk/benefit analysis the FDA stated it had the authority to remove Ephedra at any dose – thus overturning basic fundamentals of food and drug law. As long as this case stands the FDA has the legal precedent to do this with any herb or vitamin it chooses.

Actually, several people died as a result of taking products containing ephedra (active ingredient: ephedrine! Party on!) and there were more than 800 "adverse events" reported in the US, until the death of a famous baseballer brought the matter to a head.

So how about here? Annette King refers to three deaths as a consequence of taking complementary medicines. Two of those will be men with prostate cancer taking a Chinese herbal brew called K4, and there is some doubt over exactly what killed them. There is much less doubt, however, about the fact that these men, and 11 others who took the herbal nostrum, suffered liver damage. From a WHO bulletin:

In several cases, patients felt well but liver function tests were consistent with acute hepatitis. In most cases, the hepatitis resolved gradually on withdrawal of K4. Both patients who died presented with acute hepatitis which progressed to massive hepatic necrosis confirmed by liver biopsy. Screening for possible infectious causes, such as infectious hepatitis, was negative.

What I find quite unsettling is that some of the people behind the local "health freedom" lobby have persistently defended both ephedra and K4. I have trouble believing they hold my interests as a citizen and consumer uppermost.

On the other hand, I' more inclined to credit goodwill to the people at Public Citizen, which has some interesting stuff, such is this article that explains why it took so long for US regulators to act on ephedra, even though people who were following the instructions were getting sick: big money, political influence, biddable Republican legislators. More here, and some more reviews of supplement safety. The same people are equally unflinching on big pharma drugs.

Some of the most dramatic rhetoric here has poured forth from the gob of the Greens' Sue Kedgley, who argues that this "highly controversial and, indeed, sinister legislation" will "undermine our sovereignty and national identity". This weird jingoism - it'll be run by Australians! Ewwww! -- is a keynote of the argument.

Kedgley talks a lot about how products that are "FDA approved" won't be for sale here in five years time. Because of the way the FDA works, it's a spectacularly meaningless statement. As this current McClatchy news story serves to demonstrate:

WASHINGTON - The $22 billion dietary supplement industry operates with minimal oversight from the U.S. Food and Drug Administration, despite a history of suspect quality and safety -- and independent lab tests that have found one in four products to be substandard.

About one in four dietary supplements tested don't meet quality or safety standards, according to former FDA research scientist William Obermeyer, a co-founder of the independent testing firm, ConsumerLab.com, which tests thousands of supplement products.

Some are tainted with pesticides, salmonella, glass, bacteria or heavy metals such as lead and cadmium. Others fail for a variety of reasons, including a lack of ingredients, improper ingredients, failure to disintegrate properly and mislabeling.

Because manufacturers seek low-cost ingredients, Obermeyer said it's likely some of the tainted products contain ingredients from China, which typically are cheaper.

Under a 1994 federal law, most dietary supplements -- vitamins, minerals, herbs, amino acids and other substances such as enzymes and metabolites, which are taken orally and intended to augment the diet -- don't need to be registered or approved by the FDA

Read the whole thing - it's terrifying. Obermeyer's website has a lot more on shoddy products and unscrupulous practices.

Further, from the US National Institute of Health:

Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists in the United States for standardization as it applies to dietary supplements ..."

Another view:

How safe are they? In many cases, no one really knows. The U.S. Food and Drug Administration (FDA), which normally checks out the safety of foods and medicines before they come on the market, does not check on the safety of dietary supplements before they're sold. The FDA has to wait until it receives reports of problems caused by supplements before it can investigate and ban a dietary supplement.

So it relies on self-reporting from people who (especially in the case of overdosers or users of more unorthodox therapies) may not have an entirely rational attitude to what they're doing in the first place.

Anyone who thinks we should regulate the way the FDA does is nuts.

Much of the above is not directly related to the bill under consideration, but more a reaction to the character of the argument, which as David Lange put it, I find regrettable.

We certainly need a new regulatory regime, but I've yet to be completely convinced of the merits of that enabled under the bill. If it does impose genuinely onerous regulatory costs, then I don't think that's a good thing. I'd like the benefits of operating a joint regime more clearly explained to me.

But it now looks like New Zealand producers won't even have to follow the joint regime if they don't want to. Traditional Maori healers will also still be able to practice, and make preparations for those in their care; they'd only come under the scope of the system if and when they commercialised.

I can also see the merit of a libertarian argument that people should be free to neck what they like, much as I can in the case of recreational drugs.

And some supplements and therapeutic remedies, taken sensibly, are clearly beneficial. There's even a little evidence for some vedic treatments (although it's hard to say without knowing the real status of some of the journals, and the whole business is far too cultish for my taste). I'd hate to go without cherry fruit extract, whose efficacy in alleviating acute gout symptoms is a matter of more than anecdotal experience.

I'd be delighted to hear any considered opinion about the bill in the discussion thread here (assuming you still have the will to live after reading this far). I feel like there's stuff I don't know.

But the public fever over this bill isn't really over what can be known.

PS: No Right Turn skewers the journalists who ran with a meaningless Sensible Sentencing Trust poll without bothering to check their source.

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