CAM regulations “draconian, misleading and insulting”, says Leon Louw

The South African Department of Health (DoH) published regulations related to complementary medicines in 2013, and these regulations have left Leon Louw, executive director of the Free Market Foundation, somewhat displeased. In the opening paragraph, he tells us:

In the name of science, they might promote rather than curb scams and pseudoscience. Instead of protecting consumers, they erode access to products and information. They subject supposedly unscientific Cams to supposedly scientific allopathic standards. Notwithstanding the regulations and the pretentious explanatory memorandum, the difference between the two is smaller than protagonists of science assume.

Those “supposedly”‘s – along with scare-quotes around words like “unscientific” and “scientific proof” at other points in the column – seem to signal that Louw thinks the DoH has fallen prey to some sort of biased “scientism”, whereby they expect that CAMs should satisfy criteria that (according to Louw) even allopathic medicine cannot.

Complementary-Medicine-Using-NaturopathsLouw gets various things wrong in his column – perhaps most fundamentally, the idea that a double-standard might be in operation. The whole point of the regulations is to bring all medicine under one regulatory framework, and I have little doubt that the DoH would have no hesitation in calling an untested allopathic medicine “unscientific” just as quickly as they would apply that label to a CAM, if the respective medicines had not undergone some testing.

The alternative to not testing medicines – of whatever sort – is to allow people to buy what they choose, and take their chances, based on unverified claims made by the manufacturer. But this approach is clearly foolish – without monitoring and verifying those claims, including details regarding the production process (because even homeopathy might harm you, if enough impurities get into your lactose pills or water), we’re putting lives at risk.

So some framework is necessary, and it would constitute simple special pleading to want CAMs to be held to a less stringent standard than allopathic medicine is. Seeing as we want allopathic medicines to be regulated (well, I do – maybe Leon doesn’t, but his column doesn’t rest on an argument for abandoning oversight for all medicines), why not require CAMs to fall under the same framework?

The fact that it’s the same framework, rather than the same exact rules for each sort of medicine, is key. Contrary to Louw’s claim of the DoH displaying its “characteristic disregard for the public and Parliament”, the guidelines on CAMs were open for public comment in 2011. I was one of those who offered comment on those guidelines, so I can confirm that I at least received a response.

It’s not sufficient, as Louw suggests, that “unless treatments are shown to be dangerous, they should be allowed without false or misleading claims”. Because the dose makes the poison, and non-specialists looking to alleviate some pain or other malady might take either inappropriate doses of something that might otherwise help them, or perhaps take an inappropriate medicine.

CAMs have been known to cause lead poisoning, for example – in a local case, an Ayurvedic skincare product put 8 people in hospital, and many herbal treatments are known to have the potential for harmful effects. You don’t need to be a dogmatic proponent of allopathic medicine to recognise that regulation could be useful for guiding consumers to make safe choices.

But Louw seems to assume that it’s this sort of dogmatism that animates those of us who support the regulations. He says

Pretentious regulators want us to believe, and may themselves believe, that science proves things. It does not. Especially not health science. There is no such thing as “scientific proof”. The father of the scientific method, Karl Popper, explained that science establishes degrees of probability, never absolutes except disproof.

There’s no such thing as certainty in science, no – but it’s misleading to suggest that there’s no such thing as “scientific proof”. When (most) scientists speak of proof, they’re speaking of the preponderance of evidence pointing to things being one way, versus the other. Overwhelming evidence is spoken of as proof, even though later information might force you to change your mind.

Louw says as much himself in the passage quoted above, and goes on to say that the preponderance of evidence can conduce to near-certainty, in some cases. So what’s the problem with ranking CAMs on this same spectrum, with medicines that might be simple placebo on the one hand, to things that can actually generate beneficial chemical reactions on the other?

It’s true, as Louw says, that mainstream medicine often starts as alternative. But this doesn’t mean that existing alternative medicine needs to be treated as if it were already mainstream, and exempted from demonstrating that it does what it says on the tin.

And it’s irrelevant that some mainstream medicines don’t do what they say on the tin, or that mainstream medicines can be found to have previously unknown or undisclosed side-effects, as with the example of statins that Louw uses. These are arguments for regulation, and for a regulator with teeth, rather than for no regulation. Misleading claims – for any sort of medicine – need to be exposed, and those who make misleading claims need to be censured.

“Consumer rights are violated by laws that ban nonfraudulent products and good-faith claims”, Louw says – but I’m puzzled by how we would be able to distinguish fraudulent products from non-fraudulent ones, and good-faith claims from bad-faith ones, without some sort of set of standards for claims and products.

Those standards are what the framework is offering. It’s entirely reasonable to argue that the licensing procedure is too expensive, or too onerous – but Louw seems to be suggesting that it’s entirely inappropriate to require this form of oversight, and this seems an unreasonable position to take in light of the potential (and demonstrated) risks.

As for whether the process might be too expensive or onerous, I don’t think it is. CAM producers need to pay R 5 500 per registration (for registrations that don’t require a toxicology report), and account for the quality, safety and efficacy of the product. Depending on how ambitious your claims of efficacy are, you need to provide less or more evidence to support those claims.

So long as your product isn’t harmful, and you want to market it as a “tonic for well-being” or somesuch, there’s little indication that this will prove little more than an admin headache – and recouping R 5 500 from your customer base shouldn’t prove that difficult. On the other hand, if you want to claim that your product cures cancer, some serious evidence would (rightly) be demanded.

As Kevin Charleston puts it, the “MCC have got it just about right: a compromise with which neither side feels they have won the absolute advantage. It is not perfect, but I think it is workable.” Those of us who are skeptical of alternative medicines have to tolerate the fact that they are taken seriously by the medicines control council – merely treated as medicines, in fact – and those who are fans of alternative medicine need to take responsibility for giving consumers value for money.

Far from reducing customer choice, the regulations enhance those choices. For how can you call something a choice if you don’t know what you’re choosing?