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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About @advodiaboli
I'm not really a cast iron flying pig.

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