Patients before paradigms

Debunking the paradigm defence

It is often argued that complementary or alternative medicines should not be judged or regulated according to the same criteria as pharmaceutical medicines. The argument is logically flawed and it also puts the interests of health providers ahead of patients.

In our paradigm, the hair of Ziggy the labrador has miraculous healing powers
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.

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Comments in chronological order (2 comments)

Jack Lewis wrote on 15 April 2011 at 7 a.m.:

Apropos Ziggy!

Researchers claim that animal owners are less likely to develop non-Hodgekin's lymphoma, a cancer of the lymphatic system that affects around 9000 Britons an year. This is mainly due to the boosted immune system made effective by pets, which was discovered in a study conducted by scientists at University of California, SF and Stanford University also in San Francisco. Previous studies have proved that children with pets have taken fewer days off and toddlers who grew up around cats and dogs are less likely to suffer allergies or asthma. The lymphatic system is mainly affected in non-Hodgekin's lymphoma or NHL, where a network of vessels and glands that transports infection fighting blood cells round the body.

For the sake of statistics, the number of people affected by this disease is steadily rising at 4% for the last 50 years, which might make NHL as common as breast cancer or lung cancer. The results of certain tests conducted showed that pet owners are 30 per cent less likely to have cancer than those who never kept pets. Researchers are still working on the exact cause of NHL and its contributing factors, which is a large-scale study that will manifest results with time.

Roy wrote on 15 April 2011 at 7:51 p.m.:

This is a beautifully clear argument, Marcus.

When the definition of a medicine states "purports to be suitable for use for . . ." this is clearly equivalent to what you're referring to as the "outcome". I agree that we should be looking at the outcomes of the use of all medicines in a scientifically acceptable way.

The other aspect of making claims that Ziggy's hair has healing properties for cancer or for AIDS is whether medicines which treat cancer and/or AIDS have been called up. They have. And not based on their formulation or whether they are complementary or conventional medicines -- but based on their actions (outcomes). Regulation 25 of the Medicines Act lists all the medicines (classes and categories) that have been called up.

So, unless you can provide the data as required by the MCC for registration of Ziggy's hair (that unequivocally prove that Ziggy's hair works) and have it accepted by the MCC -- it would be illegal to market Ziggy's hair as a healing agent. Just as so many other dubious (sorry Ziggy!) products being marketed in South Africa is surely illegal.

But no-one in authority seems to care, and as you say, the providers of these products are privileged at the expense of the consumers! Surely this contravenes the Bill of Rights in the Constitution of South Africa.

So let's start looking at outcomes using the scientific paradigms that have been proven.

@Jack With respect, Marcus's argument has nothing to do with being a pet owner, but is about whether a particular component of that pet (Ziggy's hair) is an effective medicine.

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