Thank you for your reasoned and patient replies to the correspondence on Red
Yeast Rice (BPJ 32, Nov 2010). Indeed the Becker study comparing simvastatin plus written diet and exercise advice,
against red yeast rice tablets, plus fish oil supplements, plus a 12 week supervised and coached exercise programme,
plus counselling from a dietician, is one of the best examples of the worst way to do a clinical trial, from which,
no scientific conclusions can be drawn. A correct scientific study would have been comparing simvastatin, plus written
diet and exercise advice, against red yeast rice tablets, plus the same written diet and exercise advice. In my opinion
it is amazing that this study was even published.
A further matter for consideration is that to my knowledge, herbal medicines/supplements are not subject to any mandatory
regulatory requirement for safety or toxicity testing prior to being launched on the unsuspecting public. Thus we doctors
often may advocate to our patients herbal or nutritional supplement products which have no safety testing whatsoever.
Medicines such as simvastatin are required to conform to safety and toxicity testing including single dose toxicity
lethal dose, repeat or ongoing dose toxicity, carcinogenicity, genotoxicity or mutagenicity and embryotoxicity or reproduction
toxicity. If the regulators believe that a medicine is safe in all of these areas and the proposed medicine dosage for
humans is significantly less than the dosages which could cause potential problems in animals, then the product is allowed
to be safety tested on volunteer humans. Further clinical studies in efficacy and comparison with other therapies continue.
As well as this progressive safety hierarchy of medicine testing, we currently have post-marketing studies and intensive
adverse drug reaction reporting to give us more data on any unexpected positive or negative effects once a medicine is
registered and in use. Indeed, we usually think in terms of unexpected new negative effects showing up. However, the
recent large scale study reported in the Lancet showing use of statins causing a significant 12% reduction in the incidence
of bowel cancer, shows that such surveillance can bring up further positive effects that the initial pharmaceutical manufacturers
and investigators never envisaged.
I know of no such safety procedures with any of the myriad of herbal and nutritional supplements, vitamins and “natural” remedies
that I see marketed at present. If we GPs are going to follow the dictum “Primum Non Nocere”, how can we
confidently say to our patients it's safe just because it's natural? We may easily blame the pharmaceutical industry
for withholding data, poor study design or investigations being done by people with vested interests. However, registered
medicines that I use still have a markedly better basic consumer safety system than our “feel good natural products
Dr Steve Culpan, GP