This is an invited article by a guest author who points out a discrepancy between the 'talk' and the 'walk' so often demonstrated by dedicated sellers of complementary medicines.
Here’s a quote from the Health Products Association’s (HPA) website written by pharmacist Brent Murphy, B.Pharm (RHODES), MPS, and a director of Solal Technologies, about natural and complementary medicines which bears closer scrutiny:
‘What about the fraudsters?
In the current climate of poor regulations, there are a few charlatans out there. These companies profit from the desperately hopeful by making exaggerated claims of effectiveness, such as a substance showing possible benefit for the immune system suddenly becomes a cure for AIDS, or something that is an antioxidant is marketed as treating cancer. When these fraudulent and exaggerated claims are exposed, it gives the impression that natural and complementary medicines are based on quackery and mumbo-jumbo pseudo-science.’
Is there a current climate of poor regulations?
Yes. The Medicines Control Council (MCC) have not yet finalised the Regulations for Complementary Medicines despite the first draft of these being gazetted for comment in 2004. The complementary medicines industry, including the HPA, essentially prevented their implementation through their objections. But the MCC’s website still states that all complementary medicines are subject to the Medicines Act. There is probably little need for separate Regulations because the Medicines Act, as it stands, adequately caters for all medicines. The deeply flawed Complementary Medicines Call Up of 2002 has, according to the HPA been rescinded – but because the HPA has appealed this decision, the situation is in a state of limbo. It is not known when this appeal will be heard. In the meantime, thanks to the HPA, the public continues to be exposed to thousands of products which are not regulated at all.
Are there a few charlatans out there?
No – there are hundreds if not thousands of charlatans cashing in on an assumed regulatory vacuum. Those products that have been taken to the High Court however (e.g. Dr Rath’s vitamin therapies for AIDS) have been judged to still be subject to the Medicines Act.
The charlatans have simply chosen to not submit their products for registration with the MCC probably because mostly they know they would not be able to provide the necessary evidence and data. This means that at present no regulatory authority is independently checking that these products are safe, of adequate quality, and effective. The public therefore directly carries the risks themselves. The sellers / manufacturers of these products are ‘de facto’ conducting unauthorised medical experiments on the public without the public’s fully informed consent. Fully informed consent cannot be given if the sellers / manufacturers have not done the studies in humans to prove that their products are safe and effective. This contravenes Section 12 Clause 2c of the Constitution of our country which requires that [fully] informed consent be given for any medical or scientific experimentation in humans.
The risks to the public are also financial (spending money on products that have not definitively been shown to work). Health risks could arise due to delays in seeking medical diagnosis and treatment, especially because as part of the natural and complementary medicines industry, people are encouraged to take ‘self-responsibility’ and to ‘self diagnose’. Self diagnosis based on insufficient training and/or understanding of pathophysiological processes is in fact the very opposite of taking responsibility for oneself. But where does the responsibility lie when individuals and companies sell products that have not been adequately proven to be safe and effective?
Do these companies profit from the desperately hopeful by making exaggerated claims of effectiveness?
Yes the companies profit enormously. The estimated value of this market is in the region of R5 billion a year in 2010. There are many desperately hopeful vulnerable people who are willing to try anything when they have serious conditions such as HIV/AIDS or cancer; or even those desperately hopeful vulnerable people who just want to lose weight. Charlatans almost always, by definition, prey on vulnerable people. The claims of effectiveness are always exaggerated if the specific products (not just a few ingredients), have not been clinically proven to do what they claim to do.
Do companies misrepresent substances showing possible benefits for the immune system as a cure for AIDS?
Yes. The controversial Ubhejane would fit into this category – despite recent claims that it has been ‘registered’ by the MCC. It has probably been submitted to the MCC under the deeply flawed Complementary Medicines Call-up and received a ‘registry’ (or tracking) number. A number of companies (including HPA members) display the registry/tracking number in their advertising, on their websites, and even on the labels of their products to give them a look of legitimacy.
It is interesting that the HPA is willing to be bedfellows with, and protect the interests of the sellers and manufacturers of Ubhejane — a direct consequence of their appeal.
Other products do not claim to cure AIDS, but do claim that they may be helpful in assisting the immune system to control HIV. Examples of some of these inadequately proven substances available from Solal Technologies include lipoic acid, bitter melon, carnitine, curcumin, cysteine, DHEA, and several others.
Do companies misrepresent some antioxidants as suitable for treating cancer?
Yes, although the claims may be modified or softened to include substances other than antioxidants; and may further imply that the substances they’re selling are suitable for helping with, or even in preventing cancer. Some products focus on the dangers of ‘free radicals’ without recognising that free radicals themselves may help prevent cancer by killing aberrant cancer cells. Some products claim to counteract cancer through the immune system. Examples of the substances available from Solal Technologies for which cancer claims are made include: epigallo-catechin-gallate (EGCG), carnosine, chlorella, conjugated linoleic acid (CLA), co-enzyme Q10, curcumin, cysteine, dimethyl-glycine, ascorbyl palmitate, selenium, lipoic acid, arginine, Ashwagandha, beta-sitosterol, and several others. None of these are adequately proven clinically.
Is the impression created that natural and complementary medicines are based on quackery and mumbo-jumbo pseudo-science when fraudulent and exaggerated claims are exposed?
Yes, although believers in these products usually don’t concern themselves with the science or the evidence. Unfortunately fraudulent claims are not adequately exposed because of organisations like the HPA protecting its members’ businesses at the expense of the public and ordinary consumers. The evidence for this is in the appeal launched by the association against the rescission of the complementary medicines call up.
The quote used above is part of a longer article called ‘Science or Mumbo-Jumbo?’ written by pharmacist Brent Murphy. He is a Director of the company whose products have been used as examples in this blog (except for Ubhejane). In analysing the claims for the examples used, many of them do qualify as pseudo-science. Some are based on animal studies. Animal studies cannot be used to make claims of efficacy in humans. Others are based on laboratory studies on cell lines — which also cannot be used to make claims in living human beings. Others are based on study samples which are too small and/or the study is not long enough to draw valid clinically statistical conclusions. So who does Brent Murphy really consider to be a fraudster?
Unfortunately, many in the natural and complementary medicines industry present themselves as being upstanding and honourable citizens of our country despite knowingly selling unproven products. The Simply Slim saga is an example of this. Even more unfortunately, some of the sellers / manufacturers of unproven products who prey on a vulnerable and desperate public are health professionals who should know better — including doctors, pharmacists, dieticians, and nurses, amongst others.