NPS urges independent advice as Blackmores deal may contravene legislation

Already the myth that the AMA is critical of Blackmores scam to push woo woo at point of sale because of profit jealousy has emerged.

Whilst there are justified criticisms of medical and pharmaceutical industry cooperation, it is frequently blown up to conspiratorial levels. Or misunderstood as being a negative influence on doctors in total. There’s no evidence doctors are immune to incentives – none of us are – but regulations and guidelines exist for a reason. Also, the strongest push to place ethics before the benefits of pharmacy marketing comes from doctors themselves.

Quite frankly though, it also has zip to do with this new problem lapping around the ankles of patients visiting pharmacies to have scripts filled. Drugs work. In the vast majority of cases the consumer can choose a cheaper brand at point of purchase. Alternative products may loosely be said to not so much work, as to carry almost no risk. And this lack of risk, if you pause and think, by definition in the vast majority of cases brings a lack of efficacy. That is, after all, the basis by which they make it onto shelves. That is what differentiates a listed product from a regulated product.

You may have noticed there’s no black market in echinacea. “Naturopath shopping” due to a high tolerance of spirulina or glucosamine isn’t a problem. Clandestine labs aren’t employing criminals to smurf homeopathic tablets so the latest ATS can continue to be supplied. Pharmacies aren’t ram raided in the dead of night so the probiotic fridge or magnesium supplements can be carried off. No cries in emergency departments of “Quick nurse… two teaspoons of Ethical Nutrients fish oil… No – make that Cod Liver Oil. And no fruity flavour Godammit!”.

Alternative medicines have been shown to not work reliably over and again. Those with demonstrable effect suffer from unpredictable results, varying concentration and drug interaction. If Blackmores’ hanky panky does anything well, it’s interferring with the expected effect of real medication. Being not customised per patient needs, it’s impossible to claim one size fits all immediately after claiming it is for something so difficult to quantify as “nutritional deficiency”. A deficiency that may or may not exist at all and if so, demands individual follow up and perhaps a pathology test.

Yet side stepping this final step in patient specificity is exactly what Blackmores seeks to do in mass managing highly specific, and very rare, potential eventualities.

Which brings us back to the grandiose sell being pushed in Blackmores promotion. Claims made in advertising are frequently not backed by evidence. 80 of 82 complaints pertaining to the relevant Advertising Code this year were upheld by the TGA. The two failed complaints were specific to competing companies.

Yet presently there’s no way to follow through and prosecute for non compliance with TGA demands to address false advertising claims. Readers may remember crook and homeopath Fran Sheffield smirking at TGA demands to publish a retraction of outrageous claims on her website. It is simply not cost effective to prosecute, according to the TGA. Indeed it is so cost ineffective, it is not judged to be in the public interest. Pages 130-131 of The Auditor Generals Report into the TGA and Complimentary Medicines, includes;

The TGA’s Advertising Unit is not aware of having successfully used the full range of sanctions, such as seeking a prosecution for breaches:

Due to the very low financial penalties currently available (a maximum of $6600 for individuals and $33 000 for corporations) for advertising offences in the Act and other investigative priorities for the TGA, it is not cost‐effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence for consideration of prosecution by the Director of Prosecutions …

It has never been cost‐ effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence.

The size of penalties attached to criminal offences may also mean that it is seen as not in the public interest to proceed. This view is consistent with legal advice provided to the Advertising Unit about specific breaches.

The TGA has also observed that “prosecution is currently the only available option where administrative requests fail to achieve compliance”. There have never been any cases that have been referred for prosecution action and accepted.

In 2010 a DoHA review found 90% of products reviewed were found to be non-compliant with regulatory requirements. The infamous 31 products selected at random yielded 68 breaches;

20 medicines had labelling issues such as non‐compliance with labelling requirements and/or breaches which may mislead consumers.
12 included incomplete and/or inappropriate information on the Australian Register of Therapeutic Goods (ARTG).
22 were found to have manufacturing and/or quality issues.
14 did not have adequate evidence to substantiate claims made about the medicines.

It is into this highly unsatisfactory environment the Blackmores Beast is born. Ken Harvey has written an excellent summary in addition to his Fairfax piece noted in the last post. Pharmacies to push supplements as fries and Coke to prescriptions is hosted on The Conversation.

In a change from Pharmacy Guild president Kos Sciavos being “personally thrilled” to announce the deal, it now also emerges;

The National President of the Pharmaceutical Society of Australia, Grant Kardachi, is meeting Blackmores this week and will seek an apology for the damaging and denigrating comments made about the profession of pharmacy.

Mr Kardachi said the “coke and fries‟ comment by Blackmores‟ Chief Executive was more than unfortunate and ill-considered.

One can only await further developments with interest.

In other news…

 The NPS have come out against the deal:

Whilst contravention of legislation has also been raised:

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Guild & Blackmores “naive money-grubbing action”

Today’s Letters to the Editor in Fairfax’s The Age offer ample criticism and no praise for the Blackmores scam (see PDF below) outlined here recently. Pharmacist and health store proprietor, Ian Collins writes;

AS A pharmacist and health store proprietor, I find the guild’s action of linking with one company a most naive and money-grubbing action. To be forced to recommend one company bringing out a new range of products, whose composition has not been widely discussed and has no track record, is beyond belief. To attempt to give all people with blood-pressure problems, no matter what the cause, one formula, ignoring all other health factors, is incomprehensible.

There are so many other products from different brands that may be more effective, products with a history of being useful; why pick this small range of untried products? Maybe the answer is that complementary medicine is basically ignored in pharmacy degrees and very few pharmacists have the knowledge to discuss or ask the relevant questions regarding complementary products.
How embarrassing for pharmacists to be caught with their hand in the till.

Prominent Mornington skeptic Graeme Hannigan writes;

I AM a health consumer and am disgusted at this agreement. If it wasn’t enough that pharmacies credulously offer such quackery as ear candles and the good old magic water of homeopathy, the agreement with Big Quacka means that any lingering vestiges of trust in pharmacies has vanished. Pharmacies are putting financial objectives well ahead of the ethical treatment of customers.
All guild pharmacies should come with a health warning and advice to customers to wash off the snake oil after visiting their pharmacy. I trust the guild will also make available the results of the peer-reviewed randomised double-blinded clinical trials of Blackmores Companion preparations so customers can make informed choices.

In a comprehensive Opinion article, Dr. Ken Harvey digs for some evidence to back this caper, finding little more than a business deal. He writes in part;

So what is the evidence to support the use of Blackmores Companions products?

Its Biotic Companion contains the probiotic strain Lactobacillus reuteri, which is claimed to reduce antibiotic-associated bloating, flatulence and diarrhoea. The risk of suffering these side-effects is relatively low. There is some evidence certain probiotics may reduce the incidence of antibiotic-associated diarrhoea in some populations, but routine use is not recommended by medical authorities. In immune-compromised patients, occasional cases have been reported where probiotic organisms have caused serious blood-stream infection.

Anti-HT Companion contains zinc gluconate to complement use of antihypertensive therapy. There are occasional reports that such therapy may lower zinc levels, but I am unaware of any independent medical authority that recommends routine zinc supplements with antihypertensive drugs.

Stat Companion contains coenzyme Q10 and vitamin D3 allegedly to support statin use. Muscle pain occurs in about one to two patients in 1000 receiving statins, especially if a high dose is used. The evidence that coenzyme Q10 and vitamin D3 can relieve statin-associated muscle pain is not clear-cut and the evidence that taking these ingredients together with statins prevents muscle symptoms is even less clear. As a result, the routine use of CoQ10 and vitamin D in statin-treated patients is not recommended.

PPI Companion contains magnesium to aid use of proton pump inhibitors. There are only occasional reports of clinically significant magnesium deficiency occurring in the many patients receiving PPI therapy. If this rare problem is diagnosed, the recommended management is to stop the PPI. Routine supplementation with magnesium for all patients on PPIs is not recommended.
The fine print of the material Blackmores provides about its products states that if a nutritional deficiency is suspected, pharmacists should refer customers to their GPs for further investigations. I agree.

When the rare person develops a nutrient deficiency on a prescription drug, the evidence-based approach is to confirm the diagnosis objectively with a blood test, case by case, and then treat accordingly. Sometimes that might mean prescribing a supplement. There is some evidence to support that.

But what the Pharmacy Guild-Blackmores arrangement implies is supplementation en masse, in the hope nutrient depletion will be prevented. I am unaware of any good evidence to support that. More importantly, this deal unnecessarily adds to the ”medication burden” and financial cost that many elderly patients already struggle with when taking multiple drugs.

Debate over the lack of evidence to justify the move as patient, not profit oriented, was also reported in Pharmacy News. CEO of APESMA, Chris Walton observed;

We are deeply concerned that pharmacists are increasingly being asked to put their expertise and professional ethics aside by pharmacy owners more interested in making money than doing what is in the best interests of their patients

Blackmores promotional material