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Blackmore's and the Pharmacy Guild - a marriage made in Hell
Many years ago I did some stage acting, and one of the plays we performed was Rhinocéros by Eugene Ionesco which was part of what was known as "The Theatre of the Absurd", a sort of literary equivalent to surrealist art, where what was happening was challenging to the senses and the observer's perception of reality. I thought I had fallen into another Ionesco play in September this year when I read that an arrangement had been made between the Pharmacy Guild of Australia (the professional body for retail pharmacists) and Blackmore's (the country's leading manufacturer of supplements and "alternative" medicines). The proposal was that when people had prescriptions filled for certain classes of medications the pharmacist would advise them of "complementary" Blackmore's products to counter the side effects of the medications.
I suppose that I shouldn't have been too surprised, because The Pharmacy Guild has form on this. In 2005 they joined forces with the Complementary Health Care Council of Australia (the professional body for snake oil manufacturers and distributors) to run a "Natural Healthcare Expo" in Sydney. In 2008 the retail pharmacists of Australia were awarded The Bent Spoon by Australian Skeptics for the practice of selling rubbish in a manner which legitimised it by association with real, tested, effective medications and medical treatments.
This new proposal went beyond what had happened in the past. Previously, pharmacists had carried shelf loads of supplements and nostrums and if asked gave vague recommendations based on what little knowledge they had of the supposed effects of these products. The Blackmore's agreement had them recommending one of four specific Blackmore's products whenever a prescription was filled for one of four drug classes: zinc supplement to go with antihypertensives (blood pressure drugs, or ACE inhibitors), Coenzyme Q10 with statins (cholesterol control), lactobacillus probiotics to treat the diarrhoea associated with antibiotics, and magnesium supplement for proton pump inhibitors (for the treatment of gastric reflux and related conditions). It is probably no coincidence that these four categories make up a very large proportion of all prescribed medicines. The specific recommendations would be displayed to the dispensing pharmacists by the Guild software used to record prescriptions as they were filled, just in case they forgot.
Opposition to the arrangement appeared almost as soon as it was announced. One significant blow came from the pharmacy chain Chemist Warehouse, who placed signs on the front windows of all their shops saying "Our pharmacists� recommendations are not for sale. Chemist Warehouse will not participate in the Pharmacy Guild's Blackmores Endorsement program. Chemist warehouse will never instruct our staff to automatically recommend a complementary product with your prescription. Chemist Warehouse Pharmacists � Professionals Practising Professionally".
Blackmore's claimed to have scientific evidence to back up the recommendations, but this research was hard to locate. The company said that the research would be made available on their web site, but this took some time.
While we were waiting for Blackmore's to make the research available, the National Prescribing Service (http://www.nps.org.au) published the following statement:
People shouldn't take complementary medicines just because their prescription medicines could cause nutritional deficiencies or side effects.
Adding an additional medicine should never be done lightly, especially if you're already on multiple medicines -- it adds to your financial cost, and might cause side effects or medicine interactions or even affect how well you take your other medicines.
If someone has, or suspects they have a deficiency or other side effect that is a result of taking a prescription medicine, it is important for them to see their doctor and ask questions about their medicine. Evidence of effectiveness and safety with complementary medicines is often limited.
Evidence for using zinc supplements with antihypertensives
Routine use of zinc supplements is unnecessary for people taking blood pressure lowering medicines (or �antihypertensives�). There is evidence that long-term treatment with certain types of antihypertensives may reduce zinc levels, but it is unclear how often this causes zinc deficiency.
Limitations of evidence
Evidence for any benefit of zinc supplementation in the absence of zinc deficiency is limited. People taking anithypertensives should only be considered for a zinc supplement if they are deficient in zinc.
Results from the only trial investigating zinc supplementation with an antihypertensive (hydrochlorothiazide) were inconclusive.
Evidence for using Co-enzyme Q10 with statins
Evidence does not support the use of Co-enzyme Q10 to prevent myalgia (muscle pain) during treatment with a statin.
No clear evidence of benefit
No trials have shown that taking a Co-enzyme Q10 supplement with a statin prevents myalgia. Randomised controlled trials of Co-enzyme Q10 to manage statin-associated myalgia have conflicting results and do not support routine use with statin therapy.
Evidence for using magnesium supplements with PPI therapy
Magnesium deficiency or �hypomagnesaemia� has been associated with long-term use of proton pump inhibitors (PPIs). Case reports indicate that stopping the PPI is the best way to normalise magnesium levels. Taking a magnesium supplement with the PPI may not be enough to correct the magnesium deficiency.
Limitations of evidence
No studies have investigated the use of a magnesium supplement to prevent magnesium deficiency during PPI therapy. A magnesium supplement should only be considered if a PPI has caused a deficiency in magnesium that requires treatment. Evidence for using a supplement with a PPI to treat magnesium deficiency is based on case reports.
Probiotics with antibiotic-associated diarrhoea
There is some evidence from trials that probiotics may prevent antibiotic-associated diarrhoea in some adults and children. But limitations with the trials mean that the true effect of probiotics is uncertain, as is the most effective product or dose.
Limitations of evidence
There is not enough evidence to determine the following about probiotics:
(I haven't included the complete statements about each class of drugs. The full NPS commentary can be found at http://www.nps.org.au/topics/companion_products)
It seems, then, that there is little evidence to support the need for the supplements which were to be recommended to a very large cohort of prescription drug users. (Pharmaceutical Benefits Scheme statistics for the twelve months up to June 2010 show that over 72 million prescriptions were filled for the four categories of drugs. Three of the categories occupied the top three positions in the ranking of numbers of prescriptions filled, with antibiotics taking only a lowly sixth place.)
Blackmore's finally published the research supporting their four Companion Products. Unfortunately, the research wasn't made available to just anybody as you had to be some sort of "healthcare professional", although this was rather easily bypassed.
A couple of paragraphs stood out for me.
The evidence was compiled in line with the Therapeutic Goods Administration's Levels of Evidence Guidelines for listed products, and demonstrates that some prescription medicines diminish nutrients and that supplementation can improve nutritional status.
Where it says "listed products" it refers to a class of medical devices or preparations which do not have to prove efficacy, just that they don't do too much damage when taken according to directions. Put another way, for something to get a "Listed" classification it does not have to be shown to work or even provide any benefit at all. Homeopathic products are "Listed". Real medicines are usually "Registered", because that classification means that evidence has been produced that they do what the promoters say they do.
In addition, evidence was sourced using two key resources identified by the National Prescribing Service as having the highest quality of information for complementary medicines: The Natural Standard Professional Database and the Natural Medicines Comprehensive Database.
Leaving aside my opinion about databases of magical snake oil preparations, the important message to be taken from this paragraph is that the National Prescribing Service cited had already issued a statement saying that none of the Blackmore's Companion Products actually have any benefit at all. It is standard operating procedure for pseudoscientists to refer to authorities in the almost certain knowledge that the general public will be impressed by the reference and fail to see what the authority really had to say.
On October 5 the Pharmacy Guild bowed to pressure and announced that the arrangement was not going ahead. Even then, however, they were not apologetic, and the media release consisted largely of justifications for the idea, an example being that they said that they were just responding to "some media reporting of the endorsement which was ill-informed and inflammatory".
The release also said that "The last thing the Guild would ever want to do is deplete the credibility of community pharmacists, or damage the trust in which they are held by Australians". Perhaps one day they will realise that partnerships with pseudoscience can't possibly do anything except "deplete the credibility" of members of a scientific profession.
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