Author Archives: Paul Gallagher

Time for Blackmores to pull that evidence out of a hat

Posted in Alternative "medicine" scams, Big Placebo, Health by

Where are all the people dying in the street from complementary medicines?

Marcus Blackmore – September 2011

Although a seemingly innocuous if not arrogant turn of a logical fallacy called Begging The Question (and a few others as well) I was surprised at how gullible Blackmore may actually take Australians for. Four deaths in two years and 40 serious adverse reactions reported. But, not in the street to my knowledge. Forget the lead, mercury and arsenic poisoning from imported Chinese herbs.

In this case he’s trying to dismiss the vast vacuum of evidence for efficacy of Blackmores hanky panky, by confusing no medicine (or placebo) with a bad medicine. Confusing no effect with malignant effect. It’s also an inconsistent non-sequitur in that he’s applying the logic we would apply to real drugs (or consumer products under fire) to propose the absence of an outcome that by definition, cannot follow. Regardless of how you see this nonsense, it’s a pearler. It encapsulates so much of what’s wrong with regulation of alternative medicine today, in just a dozen words.

Fortunately for consumers it makes Blackmore look quite the villain. It has zero to do with the problem at hand. Namely the current Pharmacy Guild deal done during an evolving awareness of unsustainable claims and corresponding outrage. Although he hasn’t said this in response to recent criticism, he has been scathing of sound criticism, using this phrase before. More to the point it’s a taunting, if rather melodramatic version of What’s the harm? which to skeptics is a huge clanger. Professor Alastair MacLennan head of obstetrics and gynaecology at Adelaide University, cites “four harms of ‘harmless’ therapy”.

In the recent Trick or Treat article by Gary Tippet, MacLennan is summed up:

Probably most important is delay in seeking effective therapy, if there is one; increasing evidence of side effects and drug interactions, which are under-reported; a placebo effect that wears off within months and sees people ”becoming disappointed, disillusioned and depressed as they move along the health food shop counter seeking placebo after placebo”; and a multibillion-dollar industry that is a waste of the scarce health dollar, if they’re not doing any real good.

Interestingly, Marcus Blackmore’s Dirty Dozen words resonates more or less with each of those points. But back to the fallacy. Just because something isn’t doing harm doesn’t mean it’s doing good. Nor can potential benefits (such as supplements suitable for malnutrition) justify wide scale use or the – quite frankly – astonishing prices of Blackmores’ concoctions. Had he asked the question, “Where are all the people wasting money on complementary medicines?”, one could just steer him toward customer exit of any large store.

Fairfax Poll Today

Chemist Warehouse have made their position plain. But don’t abandon your trusted pharmacy/pharmacist. These guys are about slicing trade from competitors. Including (in my suburb) with the 30 plus metre aisle of junk potions bulging with Blackmores’ goods.

Their grab for the “integrity dollar” was written up today in The Age. The Life and Style section included a poll. Of note, the article continued:

However, in a sign the guild is backing away from the deal, it wrote in its latest newsletter that the Blackmores’ prompts in its computer system were a pilot only, which would be reviewed.
”Contrary to some media reports, there is no compulsion whatsoever on pharmacists to sell these products, nor is there any direct incentive to any pharmacist to sell them,” the guild’s newsletter said.

Fortunately the lack of evidence is now evident. In a great interview recently on ABC is Professor Paul Glaziou of Bond University from the Centre for Research in Evidence based practice. He went looking for and couldn’t find the evidence one would expect from Blackmores. He’s asked for them to make it available. He shouldn’t have to – nobody should be left looking for evidence here.

Or download here.

The clash of reality catching up with an industry that survives on social psychological trends such as the need to take control of ones health, distrust of pharmaceutical companies and a prevailing zeitgeist of choosing something – anything – natural in an environment we are erroneously told is highly toxic is getting louder. Marketers of this junk know this and they’ve been fighting a semantic battle against the growing doubts of efficacy, trying to head off reality at the pass.

We’ve gone from “natural”, to “alternative”, to “complementary” and now we’re getting scammed with Integrative. As though this cockypop mix of potion and ritual actually has a place waiting for it within the current model of evidence based medicine. Purveyors of naturopathy, vitamin therapy, supplemental, acupuncture, reiki, massage, kinesiology, meditation, homeopathy, chiropractic (the one stop shop for self-health sabotage) have delighted in maligning “allopathy” for years.

The paucity of evidence to defend the need for unproven products is summed up well by Dr Wendy Morrow, chief executive of the Complementary Healthcare Council:

Quite frankly, if complementary medicines didn’t work it would have been a fad that was here and gone in the blink of an eye. Their increasing use shows they’re not a fad, they do work if used appropriately, and I don’t see that people are going to stop using them.

Which could also be said about any of the useless rituals above which also come bundled with attacks on vaccination, antibiotic therapy, medication in general and ample conspiracies about “allopathy”. However, late on Friday Blackmores did publish a research summary. Bear in mind however that claims made in advertising are subject to the Therapeutic Goods Advertising Code which is something I wish to look into shortly.

Pharmacy news items reported on Monday October 3rd:

Blackmores reports that while there is evidence to suggest that some medications can affect how the body uses nutrients, this is ‘unrecognised or overlooked by many healthcare practitioners’. Blackmores says that the evidence was compiled in line with the TGA’s Levels of Evidence Guidelines for Listed products and demonstrates that ‘some prescription medicines diminish nutrients and that supplementation can improve nutritional status’, adding that the evidence for its Companion range was reviewed in consultation with ‘leading [unnamed] pharmacists’.

NPS have published Examining The Evidence and looked into each of the four “companion medicines”. They find evidence was “absent” except for the probiotic option, which was “limited”. To summarise each area:

  • Supporting evidence for using Co-enzyme Q10 with statins (none)

Evidence does not support the use of Co-enzyme Q10 to prevent myalgia (muscle pain) during treatment with a statin. 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.

  • Supporting evidence for using magnesium supplements with PPI therapy (none)

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.

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.

  • Supporting evidence for using zinc supplements with antihypertensives (none)

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.

  • Supporting evidence for using probiotics to alleviate antibiotic-associated diarrhoea (some)

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.

58 million prescriptions per year. Coke and fries. 90% non-compliance with regulation. No regulatory enforcement because it’s not “cost effective”. A recent audit finding the TGA has failed for decades to counter deceptive, false and misleading advertisements. If compound X is today found to be unable to make claim Y proper policing applies only to new products coming onto the market. Products already on the Australian Register of Therapeutic Goods cannot be edited.

Given what’s been leaking out about the industry and the paper tiger apathy of the TGA, it shouldn’t be surprising Blackmores’ “Coke and Fries” is geared for consumers money, not health benefits.

Floreani, Golden and the myth of homeopathic immunisation

Posted in Alternative "medicine" scams, Anti-Vaccination Lobby, Chiropractic, Denialism, Health, Scam, Science by

For a mob that officially professes “no position” on vaccination the Chiroprctors’ Association of Australia disseminate ample false, misleading and quite dangerous antivaccination hanky panky.

Take CAA NSW branch vice president, Nimrod Weiner. The Weiner from Newtown Community Chiropractic whose Nimroddery was pegged as a “rant on vaccines” by The Australian. Although he feverishly ran for cover after outraging real doctors, not-a-real-doctor Weiner’s “rant” bibliography can be found here. A hodge podge of dusty conspiracy twaddle and outright lies, much from the Australian Vaccination Network it alone refutes Weiner’s claim:

I’m good at knowing how to read a research aritcle, and knowing whether it’s viable or not. I’m also good at collecting a lot of research. This vaccine topic I update every single week. So what we’re looking at is new as of yesterday morning.

He didn’t write that, but announced this to attendees of his seminar Vaccinations: An informed choice, in what can quite justifiably be called a lie. There’s more on the entire debacle along with a Radio National segment here. At times we’ve met other crackpots from the CAA. Jason Parkes and Rob Hutchings, both of whom approach their profession like a religious fundamentalist approaches taking up arms. Warren Sipser who believes vaccines cause harm yet chiropractic “repairs DNA”. Genevieve Keating is another pleasant sounding predator who specialises in convincing parents chiropractic builds super human kids. They lean toward the weird beliefs of founder Daniel David Palmer and his views on “God given energy flows”.

Sipser was the subject of an article in The Australian headed The Chiro Kids which brought home just how ludicrous (and scurrilous) the new brand of Mystical Chiropractors really are. Thanks to Dr. Rachael Dunlop we can read the CAA’s Media Release warning CAA members of that article. It’s disturbing stuff given these quacks are subsidised by our government (Medicare foots the bill for five sessions per year) and health insurers. Written by CAA national president Simon Floreani, it is a straight out attempt at damage control, obfuscation and dodging questions.

Floreani himself has run antivaccination clinics and is a member of the Australian Vaccination Network. He describes Dorey’s little fraudulent scheme as a valuable resource for patients. Simon is married to Jennifer Floreani, famous for writing an article supposedly describing (Update – as noted below the bogus article has been removed but can be found here pp. 348-349) her newborn’s battle with pertussis, picked up from an older sibling. Given the outcome and treatment the article is almost certainly fraudulent, but if perchance the diagnosis is correct then at best it is reckless neglect and at worst simple child abuse.
She writes (bold hers):

This experience did indeed test our resolve and we were forced to draw on our support network of healthcare providers. We performed chiropractic checks on our baby daily and utilised a whooping cough homeopathic. I dosed myself with an array of vitamins to boost his immunity via breast milk and kept him hydrated with constant breastfeeding.

Whooping cough is often slow to develop and may respond well to conservative management, including chiropractic, osteopathy, homeopathy, herbs, acupuncture or acupressure. Within two days, the severity of our baby’s symptoms cleared and within a two week period, each of our boys had a complete resolution of their symptoms.

Fortunately for the Floreani’s this little tale is just that – a tale and a comical one too. Every type of “conservative management” is absolutely non efficacious. Babies with pertussis gag, choke and may have profound difficulty breathing making this nonsense of super fortified breast milk as a realistic option seem laughable. More so, there’s no evidence an increase of maternal vitamin intake when breastfeeding will do anything but produce expensive maternal urine. Even more farcical is the notion of “boosting immunity” with vitamins. Either way, if their baby did have pertussis there’d be no magic recovery after two days but admission to intensive care many days later as the insanity of their hokery pokery gradually sank in. Yet, that’s not really the point.

The dangerous, deluded and unconscionable message pushed on parents here is that using your breasts, vitamins and witch doctor spells, you can clear up a potentially fatal disease within two days. It’s outrageous and a bald faced lie that I cannot even begin to comprehend the motivation for. What’s infuriating is that chiropractors exploit the confirmation bias in parents and the Floreani’s are prime examples.

Parents who believe these nonsense manipulations cure everything report that yes treatment keeps children healthy. They also report inaccurately that lapses in treatment lead to poor health. Knowing this, chiropractors are famous for setting treatment frequencies, with some even insisting on treatment contracts. That the locus lies with parental bias has been shown splendidly in trials on colic.

As we know, chiropractors claim they can “successfully treat” colic or – in their lingo – Irritable Baby Syndrome. Trials show that if parents believed their baby received chiropractic care, whether they did or did not, they reported improvement. If they believed that no chiropractic care was applied – even when it was – they reported a worsening of colic. You can catch up with Simon Floreani admitting no proper trials exist here on Lateline back in July 2009.

He’s caught out claiming injuries from neck manipulation are one in 5.85 million cases when in fact they are gauged at 1.3-5 per 100,000 manipulations, by insurer Kaiser Permanente, who refuse to cover the practice. In short Floreani is claiming instance of vertebral injury is 60 – 300 times less than it is.

On August 21st this year, a video entitled “Homeopathy evidence and research” filmed by Simon Floreani and featuring homeopath and fraud Isaac Golden, appeared on YouTube. The video below looks initially at the rise of the Mystical Chiropractors and then picks through Golden’s claims of Cuban “homeopathic immunisation” and his own so-called PhD on “homeopathic immunisation”.

When used to defend against a complaint to the TGA about homeoprophylaxis, Golden’s PhD actually helped uphold the CRP decision of misleading claims by fellow crook, Fran Sheffield. This is because even Golden admits in his thesis text that his sample was flawed in size and there was no chance of contracting infection. In short he showed nothing.

Enjoy…

Polio – Unconditional Surrender (1956)

Posted in General, Health, Science by

From The National Foundation for Infantile Paralysis, Unconditional Surrender looks more closely at the steps involved in making the polio vaccine.

The makers of this movie seek to educate how important the vaccine manufacture protocol, thus safety and efficacy, is. Following production comes testing and retesting. And cute bunnies. Then off to The National Institutes for Health complex where the protocol is examined. Samples from every batch end up in the labs of the NIH, tested for sterility, tissue culture, incubation tests, monkey tests… all designed to ensure safety and efficacy. Many are repeats of those done during manufacture.

In that wonderful victorious lilt of 1950’s narration viewers were held in confidence by such turns of phrase as “man’s enemy becomes his servant”. Of course, the unstated purpose was also to maintain confidence following The Cutter Incident named after Cutter Laboratories – the first lab to unwittingly dispense live virus vaccines instead of killed. This resulted in infections, and still later it became plain not only Cutter lab’s were struggling with Salk’s protocol.

It resulted in a suspension of only one fortnight. A good deal of Paul Offit’s book The Cutter Incident can be found at Google Books.

Unconditional Surrender

 

NPS urges independent advice as Blackmores deal may contravene legislation

Posted in Alternative "medicine" scams, Big Placebo, Health, Scam by

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:

Guild & Blackmores “naive money-grubbing action”

Posted in Alternative "medicine" scams, Big Placebo, Health, Scam by

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