Patients before paradigms

It is in the public interest that all claims to prevent, treat or cure disease are judged by the same strict criteria, no matter what the paradigm.

A Draft National policy on African Traditional Medicine published in 2008 stated that: “Different research methodologies and registration processes will need to be developed (for traditional medicines) as current research methodologies for allopathic medicine are not in all instances appropriate.”

It is also often argued that clinical trials are inappropriate for some paradigms of healing, that it is wrong to impose the ‘narrow-minded scientific method’ on alternative forms of healing like homeopathy or acupuncture. Even supplement companies sometimes employ the “paradigm defence”, arguing that ‘natural’ products (if you can call supplements natural) should not require the same burden of proof as pharmaceuticals. On one local pharmacy mailing list a lawyer argued that certain supplements should be regulated as foodstuffs rather than medicines.

The logical flaw in the paradigm defence is that it confuses the treatment paradigm with the outcome. There may be many healing paradigms worth exploring. But when it comes to testing and regulation we are interested in whether it works, not the paradigm. We are not testing homeopathy as a paradigm, but the claim that homeopathy can treat or cure a specific disease. And if we really care about the welfare of patients, we will make sure that we get the best possible answer to whether the claim is accurate– that is to say whether the treatment is safe and effective. Similarly, no matter what treatment or paradigm you are using, someone’s CD4 count either improves or it doesn’t, HIV viral load either drops or it does not, cancer is either in remission or it is not.

The most reliable measure of whether people get better or not from a specific treatment is the double-blinded randomised clinical trial (RCT). RCTs measure outcomes, and are blind to the details of the method, or paradigm. Rather than excluding many alternative remedies, the power of RCTs is precisely that they can give alternative remedies a fair chance by reducing bias and focussing on measurable outcomes. RCTs are not inherently 'western'. The RCT is simply the best tool we have for establishing the safety and efficacy of health interventions.

In the same way that we use clinical trials to test whether the latest experimental antiretroviral suppresses HIV, we can use them to test whether homeopathic preparations are of any benefit to diabetics. We can do similar tests with vitamin supplements and with herbs used by traditional healers. As yet, I have seen no compelling arguments as to why complementary and alternative medicines should not be subjected to these powerful knowledge-enhancing tests.

This is not just an academic triviality. Knowing what medicines are effective can determine what the Department of Health, medical schemes and individuals spend their limited funds on. It can make the difference between someone seeking appropriate help for a serious medical problem or choosing to self-medicate with an untested product. Allowing untested claims to proliferate literally costs lives.

It is therefore crucial that strict medicines regulation is written into law and that no exemptions are made for complementary or alternative medicines. And, for the most part, our legal framework does provide very good protection.

According to the Medicines Act something is a medicine if you claim it can treat an illness or condition. For example, if you claim that the hair of Ziggy the dog (pictured above) can cure cancer, Ziggy’s hair is a medicine.

If something is a medicine it is subject to the Medicines Act. This then means you may not market the medicine without it having been registered with the Medicines Control Council (MCC). I cannot sell Ziggy’s hair as an AIDS cure if it is not registered as such with the MCC. Similarly, appendix F of the advertising code does not allow me to claim that Ziggy's hair is a treatment or cure for HIV unless it is registered as such with the MCC.

The power of this arrangement is that it defines a medicine according to its claimed outcome, and not its method. That is to say, irrespective of the ‘paradigm’, medicines are all judged equally in terms of the evidence of efficacy and safety.

This system has been challenged on various fronts in recent years. From Manto Tshabalala-Msimang’s suggestive comments that ‘western’ forms of testing are inappropriate for traditional medicines to the ill-conceived complementary and alternative medicines notice of 2002 and some shocking early drafts to the medicines amendment act, it is clear that we cannot take the common sense regulation of medicines for granted.

More recently we learned that ASASA has temporarily stopped ruling on Appendix F complaints against advertising claims made by Solal Technologies who are challenging the legality of Appendix F rulings. I do not know the legal details of this case, but Solal’s response to a recent ASASA complaint makes it clear that they want to lower the burden of proof for the claims they make about their products. Should they succeed, consumers will increasingly be left in the dark about the true safety and efficacy of supplements.

It is in the public interest that all claims to prevent, treat or cure disease are judged by the same strict criteria, no matter what the paradigm. This is the only way we can ensure patient safety and protect the consumer’s right to accurate information. Any other arrangement will privilege providers of complementary and alternative medicines at the expense of the people who use those medicines.