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:

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

Blackmores’ black heart: Would you like lies with that?

One can be forgiven for wondering exactly how pharmacist members of The Pharmacy Guild of Australia, will keep a straight face when giving advice about medication.

Not that they don’t have the training to do so. Far from it. Which is what makes the money spinning deal to push Blackmores’ “companion products” to certain medications particularly galling. By it’s very nature this “Coke and fries” (to use Blackmores term) deal is predicated on pharmacists pre-empting doctors and making on the run diagnoses. Diagnoses that they aren’t equipped to make and that may also prove deleterious.

The scam works like this. Blackmores have identified key prescription medicines and isolated potential “nutritional consequences”. They’ve proposed a “companion product” to the prescription with scant regard to the fact that no standing recommendations exist. More so, research into this approach to supplements is both ambiguous and has revealed negative effects.

The four areas you should be terrified about are:

  • Proton pump inhibitors and magnesium deficiency with muscle cramps, vertigo, hyper-irritability, excitability and the inevitable poor concentration. But if you can remember where you’re going for long enough you can limp to the chemist, stagger from wall to wall and unleash your hyper-rage upon stock to ensure a swift diagnosis.
  • Antibiotic treatment, upset GI microflora and the need for probiotics helped along by icky stories of bloating, farting and diarrhoea. Fear not you gaseous, smelly, splattering assault upon polite society, for they have just the probiotic for you.
  • Anti-hypertensives and zinc deficiency along with poor immunity, poor appetite, impaired sense of taste and smell. Topped off with poor skin health (delayed wound healing), GI tract issues with the inevitable diarrhoea which compounds zinc deficiency. Can’t eat, can’t heal, can’t taste, can’t smell and you’re stuck in the toilet. There’s a plus in there somewhere but no doubt you need a zinc supplement.
  • Statins (cholesterol lowering drugs) and myalgia plus (get this) “muscle soreness”. Along with cramping, weakness and fatigue, you clearly need Coenzyme Q 10 and vitamin D3. What a pity you’re already too shattered to get out of bed.

Of course dealing with the nutritional consequences, may have… er, consequences. For example Blackmores go on to tell consumers, CoQ10 may:

• Have hypotensive effects in patients with hypertension and may have additive effects on antihypertensive medications

• Interfere with some types of chemotherapeutic agents. Use with caution

• Decrease the anticoagulant effect of warfarin

• Decrease blood glucose levels in people on hypoglycaemic therapy

Vitamin D3 may theoretically cause hypercalcaemia if taken with thiazide diuretics. Caution is advised in those with hyperparathyroidism, malignancies that increase serum calcium levels or other risk factors for hypercalcaemia. Zinc may decrease absorption and blood levels of tetracycline and quinolone antibiotics unless doses are separated by at least 2 hours.

Magnesium may decrease the absorption and efficacy of tetracycline and quinolone antibiotics, bisphosphonates and chlorpromazine unless doses are separated by at least 2 hours. If using [Blackmores’ probiotic] with antibiotics to which [Blackmores’ probiotic] is sensitive, separate doses by at least two hours.

This is enough to make you pause and think about chatting at length with your doctor. There’s a few other useless spooky observations that the (s)CAM industry simply rock at pulling off. Such as vitamin D deficiency being widespread and associated with poor CV health. Magnesium contributes to healthy teeth, bones, muscle/nerve function, electrolyte balance and normal energy metabolism. Myalgia is one of the most common reported adverse effect of statin use.

Many patients – particularly older ones – may already have poor nutrient intake… 1/3 of Aussies over 18 don’t get the RDI of magnesium. My favourite is the veiled suggestion GP’s aren’t capable of doing their job: “…the TGA have advised prescribers to be alert to hypomagnesaemia in people taking PPIs”. To which I can easily imagine Professor Farnsworth from Futurama saying, “Why yes… which is exactly why cowboy’s like you should stay the hell away from grown up science”.

With the help of Dr. Ken Harvey, who we know here from the SensaSlim saga, we can pin down the extent of frivolity being advanced by this joint venture. The statin claims are particularly bold, given side effects. Also, noting Wyman et al;

Some small clinical trials seem to show that coenzyme Q10 supplements can be used to lower blood pressure and to treat or prevent myalgia caused by hydroxymethylglutaryl coenzyme A reductase inhibitors (statins). However, larger trials are needed to determine if they are truly effective for these purposes.

On the topic of probiotics, The March 2011 issue of Therapeutic Guidelines Antibiotic, states;

There is some evidence that prophylactic probiotics reduce the incidence of antibiotic-associated diarrhoea but the appropriate combination of agents has not been established, so probiotics cannot be recommended for routine use. In immune-compromised patients, occasional cases of probiotic-associated bacteraemia have occurred

Regarding zinc and magnesium supplementation there is no standing recommendation for use with anti-hypertensive therapy and PPI use respectively. As Farnsworth just reminded us, being on the lookout for symptoms is for trained health professionals. Blackmores’ hijacking of professional guidelines is just another trick for selling for the sake of it.

Consumers Health Forum of Australia chief Carol Bennett claims in Fairfax that the entire caper is unethical and urges consumers to demand evidence and report pharmacists who lean on fears. Geraldine Moses, who is a drug safety researcher reminds us of the folic acid related seizures epileptics sustained after taking a supplement to combat the reduction in folate specific to epilepsy medication.

Today The Age reported;

PHARMACISTS have been accused of putting money ahead of patients’ interests after striking a controversial deal to market dietary supplements with prescription medicines.

The Pharmacy Guild of Australia, which represents 94 per cent of Australia’s 5200 pharmacies, has agreed to start recommending a range of Blackmores products to patients when they pick up prescriptions for anti-biotics, blood pressure drugs, cholesterol medicine and proton pump inhibitors.

Last week, Blackmores chief executive Christine Holgate told Pharmacy News the deal meant they could provide ”the Coke and fries” with prescription drugs while providing pharmacies with ”a new and important revenue stream”.

Her comments prompted sharp criticism from doctors and consumer advocates who said it risked turning pharmacies into McDonald’s-like businesses that push products onto patients who do not need them. Under the deal, when a prescription is filled, a prompt in the pharmacist’s computer system will remind them to discuss a particular Blackmores product that has been designed to offset possible side-effects of their prescription drug.

[……]

Australian Medical Association president Steve Hambleton said the move was outrageous and smacked of commercial interest rather than clinical need.

He said he did not know of any solid evidence backing the combination of dietary supplements with the prescriptions included in the deal. ”I think the evidence for Coke and fries is about the same as the evidence for these products,” he said. Dr Hambleton said the recommendations had the potential to confuse patients, who should trust their doctors to prescribe them what they need without any conflicts of interest.

Geraldine Moses, a drug safety researcher and pharmacist based at Brisbane’s Mater Hospital, said she was concerned about the deal because of good evidence that the more drugs a person took, the more likely they were to have adverse reactions and interactions. She said while Blackmores may have evidence showing that prescription drugs reduce particular nutrient levels and that their supplements increase those nutrient levels, it was incorrect to presume that replenishing those levels was the right thing to do.

Outrageous, unethical and potentially dangerous according to experts. This is undoubtedly a grab for money targetting a demographic that is unable to afford trumped up scams with potential risks. Given the appalling performance of the alternative product industry in the recent Auditor General’s Report and concerns raised about regulation of same in the TGA Transparency Review in July, the Pharmacy Guild should be ashamed of itself.

I wish Professor Farnsworth could get a piece of them.

Homeopathy is baloney

A nice video montage of various clips relating to the pros (cough) and cons of homeopathy.

If homeopathically labelled it might read Facts 40C, Baloney 15C. This means that factual material has been vastly more diluted than complete baloney. Which means there’s more impact from fact in this video than hokery pokery. That in itself makes no sense – so we’re off to a good start.

The surprisingly honest episode of Today Tonight featuring Richard Saunders of Australian Skeptics is interspersed with other material. Paul Offit explains the uselessness of Oscillococcinum, James Randi pops in with a refreshing use of the words “health scam”. Simon Singh appears on the BBC and Aussie TV and we meet Mark Wild, a British filmmaker whose decision to use a homeoprophylactic for malaria almost killed him.

Don’t miss the hilarious Charlene Werner casually redefining Einstein’s equation whilst lecturing in homeopathy. And we thank “quantum healer” Joshua Bloom just for using the word “quantum”. Kudos to the guy from Futurama.

Vaccination’s vexed link to bad journalism

Since the obliteration of both Andrew Wakefield’s character and his fraudulent claims, the “vaccines cause autism” lobby has become a most fascinating creature.

On the one hand we have the devout. The fundamentalists waging an emotional jihad against academic reality. Time and again they try to resell Wakefield, sully those who exposed him, concoct some bizarre “confirmation revelation” by distorting other research or parade a wounded parent.

Some plot to sell the compensation myth using cases of children with autism who sustain a vaccine injury. Or children with complex developmental disorders and autistic-like symptoms that were exacerbated by vaccination. Well aware this is not “compensated because of autism”, their intent is to trick others into joining or rejoining their cause.

Others seek to mask their intent. The flawed August attempt by David Austin and Kerrie Shandley from Swinburne to exhume the mercury autism corpse, made it as far as The Age in Melbourne. Devotees to the mercury-in-vaccines cause and members of the Who’s Who of this junk science even these culprits had to publically admit to a meaningless sample, an unproven hypothesis. Yet still they crowed success.

Most recently independent multi-topic author Marj Lefroy joined the obfuscation approach in publishing Vaccination’s vexed link to autism – a “life and style” opinion piece. Posed as a thoughtful observation it soon gives way to a clearly predetermined agenda. All the sign posts are there. The screaming baby being jabbed in the arm file picture, the sheer ignorance of the topic of both vaccination and autism, the erroneous exaggerations, appeal to authority, the seemingly unanswered questions.

It winds up being a free kick for the “vaccines cause autism” lobby. As such it tries to get away with an appalling journalistic standard, void of corroborating research. For example the case of Hannah Poling is raised as some type of proof, yet later Lefroy brings up Dr. David Amaral – who I wrote about recently – as he’s cautiously postulating a maybe. Hannah Poling was destined to manifest the symptoms of mitochondrial enzymatic deficiency vaccines or not. Underlying causes precipitating autistic like symptoms, do not an autism diagnosis make. This is what Amarai is alluding to. Other references to soundly debunked crackpot claims in the US are most cringe-worthy.

Lefroy begins;

Vaccines and autism: why this curious case is not closed

The case is closed. There’s nothing curious about it. An abundance of research has shown no causal relationship between the two and health authorities have bent over backward accommodating the goal post shifting of the anti-vaccination lobby. It remains a threat to confidence in vaccines, thus public health due to articles like this. It is the lack of understanding around autism and the presence of conditions with autistic like symptoms that is a problem.

For many parents, childhood vaccinations are this century’s abortion debate – highly divisive and driving a wedge between friends and neighbours. In the red corner are those banging the ‘vaccinate at any cost’ drum, and in the blue corner a collection of concerned parents and carers who say they’re dealing with the damage done.

Immediately the choice to vaccinate is cast as a thoughtless ideology beholden to vaccines. “Vaccinate at any cost”? This predicates that understanding vaccination means accepting there is a large scale cost to be paid. In truth the only cost in town is that accompanying the decision to not vaccinate. The steadily rising death and permanent injury toll from vaccine preventable disease is forgotten. There are far more common accidents than vaccine injury.

Eg; In the USA 10 children die of gunshot wounds every day [Tanac R et al. “A Case of Gunshot Wound Presenting with Atypical Cardiorespiratory Findings”. Journal of Pediatric Sciences. 2011;3(2):e78]. Aussie kids drown, die on the roads, in accidents at home or become permanently disabled before vaccine injury comes close.

Those in the blue corner, “concerned parents and carers”, are cast as victims of Lefroy’s non-existent ideology. Worse, they are dealing “with the damage done” (from vaccination). This is a complete distortion of the reality.

Firstly, parents with a child who has a condition some blame on vaccination are by no means unanimous. Quite the opposite with parents of such children far more often in favour of vaccination and properly armed with the facts. Secondly most in this other corner adhere to a belief system void of reason, evidence and the vast weight of research. A belief that says far more about their own irrational and tribal rejection of conventional medicine. There’s no evidence the bulk are even parents, much less with a vested interest. They overlap with new age impossibilities and sheer crackpottery.

Claiming they’re “concerned parents and carers”, is a rubber stamp of Lefroy’s ignorance. Organised anti-vaccination lobbyists such as Meryl Dorey and Viera Scheibner in Australia double as scam artists and law breakers. In the main they have very little in reality to deal with – much less “the damage done”. So many are trying to profit from the myth that vaccines potentially cause such harm, that they actively promote it as a choice running scare tactic seminars of unconscionable content. They fall upon anti-vaccination nonsense perpetuated by the Marj Lefroy’s of this world, with glee.

For people in the pro-vaccination camp, the fact that there is even a debate to be had is vexing. “What’s wrong with these irresponsible parents?” they say. “So educated and yet so stupid! Don’t they know that MMR study was discredited? And how can you take a Playboy Bunny seriously?” But there are reasons why the case of the curious link between vaccinations and autism is not closed, and Andrew Wakefield and Jenny McCarthy are not necessarily two of them.

There’s that term Scheibner loves to use: “pro-vaccination”. As if there’s an action that follows an ideological conviction. When in fact the decision to vaccinate is a no brainer. The scale of risk one is exposed to, and exposes others too is difficult to appreciate. As I’ve hinted, those with a vested interest in alternative therapy, new age diagnosis or the sickening “treatments” offered up to parents who believe vaccines caused their child’s injury benefit every time the term is used.

But Lefroy goes one better and even puts words into the mouths of this heartless pro-vaccine-at-any-cost group. Once again the reality is quite the contrary. Health professionals are trained in vaccine myths and part of this training demands not exhibiting ones own position. There is no vexing debate, but a very real psycho-social phenomenon that at times is heart breaking but at it’s roots has the very confidence in mythology Marj Lefroy is exhibiting.

As I also pointed out above Wakefield (whose work and detraction I hope Lefroy has seen) has spawned a belief system buoyed by an army of devout followers. He travels the world persisting in the same falsehood, proclaiming he’s the victim of “a hitman” for Big Pharma. Claims have metamorphosed into everything from complex muti-faceted disorders to simple one line scare tactics about aluminium or formaldehyde. Jenny McCarthy had and has the backing of some of the most powerful media personalities in the world. Far better to calmly point out the absurdity of her claims to have “cured” her son’s autism, and that she has in retrospect edited her web site once claiming “and, boom – the soul’s gone from his eyes”, following vaccination.

If the voices of those concerned parents and carers aren’t enough, consider this: recently, in a case before the US Court of Federal Claims, the US government conceded vaccines had aggravated a young girl’s mitochondrial disorder to the point where she developed autism. As a result, the National Vaccine Injury Compensation Program awarded her family an upfront payment of $1.5 million, and an additional ongoing payment of $500,000 per year to cover her care as well as the family’s lost earnings, pain and suffering.

It has since emerged that dozens of other families have reached similar settlements, and the Centers for Disease Control in the US has announced new research into vaccine safety.

Not true. Hannah Poling was compensated for encephalopathy brought on by mitochondrial enzyme deficiency. Whilst not unusual for children with her disorder to develop autistic like symptoms in the first two years of life, her parents were adamant vaccination was the cause. They fought and won the legal case. What this says clinically is perhaps nothing new. Regrettably her parents made much of the finding calling it a “landmark” in vaccine autism compensation. Jon Poling a neurologist and wife Terry Poling a nurse and lawyer, worked hard to ensure this erroneous message got out.

Yet, again pointing to the compensation myth I opened with above, it is well known that around one in one million children develop encephalopathy following MMR. Quite rightly these children are compensated. It is certainly worth noting at least one in 5,000 measles cases develop the same condition. Thus, we can now see why it has not “emerged that dozens other families have reached similar settlements”. Lefroy’s referring to the scam involving Pace Law students in May this year (I recommend reading this) headed by perpetual touble maker and unscrupulous vaccine fear author Mary Holland.

Not only did Pace Law School administrators come out and distance themselves from the entire disgrace, rather than lending weight to vaccines causing autism, it really shows how run of the mill the Poling’s case is. As media spokesperson for the charade Danielle Orsino said at the time responding to queries for conclusive evidence, “it strongly suggests” a link. Not only did they have nothing, leading telephone interviews made up 3/4 of the sample. And weren’t ethically approved. The CDC officially denies any causal link between autism and vaccination. Period.

Consider this, too: while we still don’t know exactly what causes autism, the latest research – including the study released by Dr Amaral of the University of California last week – is coalescing around the view that it’s a combination of genetic, immune system and environmental factors. Earlier this year, Dr Amaral said that, “there is a small subset of children who may be particularly vulnerable to vaccines if the child had a precondition like a mitochondrial defect … vaccinations, for those children, may be the environmental factor that tipped them over the edge.”

So why hasn’t this come up in vaccination studies to date? Dr Martha Herbert, professor of neurology at Harvard Medical School, says, “the problem with the population studies is they aren’t necessarily designed to have the statistical power to find subgroups like that if the subgroups are small.”

That means we’re not studying the right kids. We don’t even know where to find them, because most of the time we don’t know they have those vulnerabilities until they’re aggravated. Herein lies the great mystery.

The great mystery? To whom for goodness sake? For someone who has been labelling parties and speaking for them, Marj Lefroy seems suddenly remarkably ill informed. “Mitochondrial defect” was the crux of the Hannah Poling case 3 1/2 years ago. Genetic predisposition brought on by environmental exposure in autism (never mind being separate entities) is well established. Research into autism and autoimmune dynamics has been thriving over the last decade.

Many predisposed children will in most if not all cases develop severe disability. Vaccination may temporally get the gong. As might any other medication or indeed any illness. Thankfully, science doesn’t work by gathering seemingly related material, dismissing what one doesn’t want and gushing about what one does want.

So where do I stand on this? I’m not a parent. I haven’t yet had to make the agonising decision about whether or not to vaccinate my child. But I do know this: I’m definitely pro-vaccines and understand all too well the benefits they bring, and I also know they’re toxic for some kids. Because I saw what happened in the case of one of my nephews, for whom vaccination was one of several environmental factors and assaults to his immune system that, along with genetic predisposition and an underlying vulnerability, stressed his body and his mind so much that he slipped into autism. It’s not a conclusion that his mother, a sober individual pushing 40 with an honours degree in science and a background in public health, wanted to reach, but in the end it was undeniable.

His two brothers were vaccinated too, and they were fine. He was not. And it sends a chill down my spine when people talk dismissively about the “acceptable risk” of vaccines in the context of a broader public good. If it were their child, the risk would not be acceptable. Particularly if something could be done to mitigate it without compromising the benefits – and clearly, there is.

Make what you will of this personal, emotive venture. Marj has gone all “pro-vaccine”, despite writing about it like ritual sacrifice to the gods of herd immunity. The giveaway is “agonising decision” to vaccinate. With “toxic for some” vaccines. This in itself is an intellectual absurdity of towering immorality. It sets a tone of potential doom for what is a simple, perfectly safe routine process. And why? Well through a masterpiece of special pleading we get to hear about the autistic nephew. It must be true. “Undeniable” no less – despite zero evidence to support this notion – because his mother has “an honours degree in science and a background in public health”.

Blame. The need to apportion blame. I’ve seen a lot of it in other areas of controversial public health. It’s powerful, it’s blind, it’s destructive and meaningless.

So Marj tries on her new found knowledge about vaccines, genetics and environmental factors, actually coming to a conclusion ahead of David Amaral of The Autism Phenome Project! Marj believes her nephew “slipped into autism” and has used recent knowledge to shape a rationale. Fascinating.

And don’t you go talking of acceptable risk like one in one million trivalent vaccines, vs one in at most 5,000 cases of a single disease for encephalitis. Measles will kill between one in 2,500 – 5,000 depending on age. The MMR vaccine will kill zero. SSPE will afflict one in 8,000 measles cases, the vaccine will render zero cases. Or calculate that feasibly, a person may live to be 8,000 years old sustaining the infant/childhood vaccine schedule every year and still have no serious reaction.

That “chill down my spine” should be reserved for the return of measles, polio, pertussis, varicella, rotavirus, rubella, diphtheria, meningococcal disease, tetanus….. Recent surveys using todays ASD diagnostic criteria indicate autism levels haven’t changed in 30 years – despsite the increase in vaccines.

We can change the ingredients (like we did when we removed mercury). We can change the way they’re administered (using drops instead of injections, so the virus can be broken down by the immune system’s natural defence mechanisms before it gets into the bloodstream, instead of being propelled straight into it at full strength). We can get better at identifying children with vulnerabilities and treating them accordingly. And we can persevere with research until we find out why this keeps happening.

Vaccines “…being propelled straight into it [the bloodstream] at full strength”. Of course this never happens. It’s very telling terminology and hints at where Lefroy’s loyalties lie. Injected intramuscularly there is no sudden insult. In fact, with adjuvants their role in part is to keep the antigen at the injection site longer so the immune response will be controlled and optimal. Also, to lessen the amount of antigen needed. Research will always continue and safer compounds when available will be introduced.

These are things we can and must do. The trouble is, in today’s polarised public square, the middle ground seems to have disappeared from beneath our feet. Conversations about vaccines typically descend into petty point-scoring and vilification, particularly on the troll-fertilising Internet. It discourages honest, respectful discussion. And to those who think giving oxygen to the debate will cause parents to stop vaccinating their kids, I say this: it’s happening anyway. It’s precisely the lack of information, the factual vacuum, that fuels anxiety and stifles life-saving progress.

I can’t find much fault with much of that paragraph. Only to stress the lack of oxygen has been suggested as a suitable means to keep thoroughly disreputable sources where they belong: away from influencing the public. The Australian Vaccination Network is typical. Once given ample oxygen to represent “debate” and “informed choice” they did untold damage. Only now do we know the current president is a charlatan, thief and fraud. Her reach has been pruned splendidly.

I may add however, it’s articles like this very piece by Marj that push parents away from vaccination. There’s not so much a factual vacuum as a hurricane of misinformation. The real trick parents must learn is to trust expertise, not expect to understand what they never can or conclude on what they simply do not understand.

Like any issue with a degree of complexity, there are more than two sides to this one. We must have the courage and maturity to listen to everyone, including the mothers and the fathers dealing with the unacceptable, potentially avoidable consequences. They’re the canaries in the coalmine, and the real reason why this case is not closed. It’s just that science, like the law, sometimes takes a while to catch up.

Sadly, at the last Lefroy is reverting to the past. Desperate to sound rational we hear of courage and maturity. Maturity Lefroy has forgone with respect to an autistic nephew. The work has been done Marj. The risk remains infinitesimal. Irrationality and bizarre belief is spreading, massaged and milked by fringe disciplines, alternative practices and die hard lobbyists. The canaries have been heard, the coalmine has been mapped. The case is indeed closed.

Marj Lefroy signed off as an author with a “special interest” in autism. I’d call it a conflict of interest. Many people, always ill informed, think they can blame a non-existent lag in science for something they simply cannot accept.

It’s such a pity that in this case innocent children will suffer as a result.