Chiropractors: How some are creating an unconscionable con

I just recently popped in to buy a single item at the local Woolworths. As I entered I was given a free raffle ticket. A $25 gift voucher was the prize. My Skepdar scanned for the expected catch but returned a green light rating. I acquiesced and wandered off thinking I’d be long gone before raffle time.

As it turned out an announcement shortly came over that the draw was five minutes away. I checked my ticket – number 1099. As I scanned shelves the draw was announced with the winning ticket “Ten Ninety Six… 1096”. Immediately I felt a brief intuitive Doh! as if I’d come close to winning because my ticket number was a mere three numbers off. Because I’d “come so close”, I actually felt rather good and more interested in this raffle business – as though I’d done well in the great cosmic fate of ticket draws. Part of my brain was ready to believe a confidence and satisfaction just out of reach.

Of course, this all took place in a second or two, and at much the same time I marvelled at how our brains can be so easily fooled by intuition born of utterly irrelevant information. I’d come no closer to winning than any other ticket holder in the draw. For all I knew ticket 1096 could be stuffed in the pocket of the guy on the microphone. How many shoppers lingered that extra five minutes, selecting products they may not otherwise have? But what if the irrelevant information was much more complex than reasoning odds – or if I lacked the ability to analyse the true outcome? What if I was prone to go with intuition over analysis and had an emotional investment at stake? What if there was someone nearby interested in my experience, empathetic, concerned and generously explaining that all this information didn’t present a brief belief but proof I was right in feeling better, more confident and satisfied?

I’d come for one tiny item, only been there six minutes and already found myself in a privileged few – and feeling better! What then would I make of advice to persist with faith in my intuition? How far could I be led if the information was well beyond my ability to understand or critically analyse and presented as evidence that “raffles” had significant merit for my general well being? Perhaps my friends and neighbour’s were already “raffle” devotees offering glowing testimonies. In the absence of a proper grounding in or ability to analyse the credibility of information presented to me, the more likely I would be to believe testimonies, promises and trust my intuition backed by an empathic consultant.

In fact, in a confronting article in The Weekend Australian on the high risk practice of paediatric chiropractic, we can see exactly these questions being answered. And the overall message suggests I’d be a sitting duck ruthlessly exploited and ripped off in my blissful ignorance. What’s worse I’d be likely to sing the praises of those who are misguided carers at best or unconscionable charlatans at worst. Professor Jenny Couper, head of paediatrics at Adelaide University points to evidence that shows people who consult empathic practitioners are 70% more likely to report improvement, when treated with placebo. That’s a nice way of saying 7 out of 10 people would endorse a scam if conned properly. We’ve long known about white coat syndrome and blue sugar pills being more effective than red, yellow more effective than white and “scientician” jargon. This has been great for the multitude of pseudoscientific gigs rorting gullible Aussies and by extension Australian taxpayers. But what if there was a one stop shop where everything can be maintained, improved, treated, cured or prevented?

Enter the New Age Chiropractor armed with fundamentalist mumbo jumbo a Wellness “Clinic” and the title of “Doctor”, able to tackle anything from allergies to addiction. I first encountered the bizarre, grandiose, combative and frankly offensive anti-science and anti-medicine views of these chiropractor’s when debating the merits of vaccination. More and more chiropractors were refuting vaccine efficacy, inserting themselves into debate, distributing material from their practice, offering lethal witness testimony or running evening seminars wherein they imparted the very worst of anti-vaccination propaganda. They could provide a spinal adjustment which would defy the rules of neuro-physiology, virology, immunology and optimise your immune system such that vaccination was unnecessary. In peddling such misinformation chiropractors essentially profit financially from contributing to the resurgence of vaccine preventable disease with consequent infant and child fatalities along with untold disabilities.

The Weekend Australian focuses on primary offender Warren Sipser. He distributes anti-vaccination propaganda based on debunked and dangerous far out fringe notions. If he can successfully con grateful parents to abuse their children in this way, no doubt they’ll be back for “immune optimisation” and treatment when they catch vaccine preventable disease. What’s certain is that his sleight of hand will help no-one in the sample of children who suffer terribly, endure weeks of hospitalisation, are maimed for life and who die from catching diseases he’s helping to spread. He says of his qualifications in this regard;

“It isn’t outside our role because our role is to provide information on healthcare. If there is a potential for something to harm someone, whatever that may be, I am well within my scope of practice to warn them.”

Sipser is also known in vaccine defence circles as the “expert witness” who argued in the family court against vaccination of a five year old girl. Dad had remarried and wanted the child vaccinated for her health and that of his new family. Mum was arguing the risk of vaccine preventable disease was small. Here’s where the sheer threat from people like Sipser is highlighted. Rather than explain that the risk of disease far outweighs any risk from any vaccine, he failed this mother, accepted a large fee and gave public voice to sheer quackery. This intellectual repugnance won him Fishslapper of the week – an award given by a real doctor on the Skepticbros site. Fishslapper is named after the comical health insurance advertisement, offering premiums for real treatments that featured an alternative practitioner chanting and slapping his “patient” with dead fish.

The court decision finally handed down was an order for the mother to have her child vaccinated. Many of you will remember Meryl Dorey, on and off president of the disgraced Australian Vaccination Network reacting with “Court orders rape of child… we’re talking rape with full penetration”, even disgusting her own members in an attempt to further cultivate her prison planet vaccine conspiracy. At the time various news.com.au reports noted of Sipser;

The decision shocked paediatric chiropractor and author Dr Warren Sipser. “It’s a sad situation,” Dr Sipser said outside court.

“I think it’s dangerous to impose [immunisations] on anyone when there are two opposing viewpoints and when there is credible evidence they may do more harm than good,” he said.

But there is no evidence. Far less than one in one million will suffer serious reactions from MMR vaccination. As many as one in 200 will suffer the same from measles alone, resulting in meningitis and encephalitis. Death and the brain damaging Subacute Sclerosing Panencephalitis – SSPE – are not associated with MMR. From measles cases the rate may be as many as one in 8,000 and one in 2,500 respectively. Blindness (rubella, mumps) and deafness from mumps is all too common to even contemplate gambling with an innocent childs health and life potential. Presently the rise of vaccine preventable disease focuses on “educated parents” making the decision not to vaccinate. Yet only the conspiracy minded can be sucked in by the vitriolic ramblings that dominate anti-vaccination sites. We need another variable – and that variable is people like Warren Sipser taking advantage of the many intuitive failings in human reasoning. The same failings I experienced with my Woolworths raffle ticket.

This new chiropractic belief system is almost endless. Seeing an opportunity to cash in on Australia’s growing alternative practice market many if not most chiropractors have long since abandoned their ethical standard. As long as 20 years ago, I had many professional experiences with unethical chiropractors promising the impossible to road trauma patients usually within a set number of appointments. As many patients had severe brain injuries resulting in compromised cognition it was a heartbreaking and deeply disturbing lesson in callousness and greed. Many of these cases however, were exaggerations of the concept of manipulation for lower back pain. A type of othopaedic magic. Bed wetting has been a staple “chiro’ cure” for at least 50 years and impossible claims about peripheral symptoms managed by spinal adjustments have grown steadily, culminating in today’s pseudoscientific everything.

Sipser rattles off  “colds, ear infections, colic, bed-wetting, hyperactivity, asthma” and reflux in a six week old. Think about that. Reflux in a six week old. It’s chilling to think he “manipulates” soft vertebra after massaging a mother’s irrational anxiety. As he told one mother he can “fix everything”. As such he represents a clear and present danger, not just to his “patients” but to public health in Australia. He argues, “… taking a proactive approach means you can see kids on an ongoing basis for body balance and even DNA repair.” The DNA myth is based on a single much debunked Journal of Vertebral Subluxation article. Professor Steven Salzberg, director of the Centre for Bioinformatics and Computational Biology at the University of Maryland notes a statistical error rendering it meaningless.

In 2006 chiropractors resurrected training in their 19th century founders’ teachings – this action alone representing an all too common theme for 21st century devotees of debunked dogma. Daniel David Palmer, a USA born magnetic healer believed that spinal adjustments unlock the body’s God-given energy flows. Known today as vertebral subluxation complex [VSC] this hanky panky sounds like homeopathy’s “water memory” or TCM’s “energy meridians” and “chakras”. It’s listed as one of chiropractic’s “core beliefs”. We’re told with a straight face VSC is the theory of tiny misalignments of the spine upsetting the “expression of innate intelligence”, and from there flows disease. From The Weekend Australian:

The fundamentalists argue that each vertebra in the spine influences corresponding internal organs, and that chiropractors can heal the body by correcting minor spinal lesions known as “subluxations” which affect nerve-flows. This theory has been repudiated by many leading chiropractors in the 120 years since Palmer proposed it; last year, Britain’s General Chiropractic Council reiterated that it is a purely theoretical concept “not supported by any clinical research evidence”.

Noting that this discipline attracts intelligent students it strains at credibility to accept they are about anything less than scamming vulnerable patients to line their own pockets. However, I’ve no doubt there are some New Age Chiropractor’s who care for their patients, want to do the right thing but are befuzzled by confirmation bias and struggling with cognitive dissonance. To this we must add the genuinely honest chiropractors such as John Reggars, past president of the Chiropractors Registration Board of Victoria and present vice president of the Chiropractic and Osteopathic College of Australasia.

On May 11th Paul Smith writing for Australian Doctor, published an article that referenced a paper Reggars had written targetting the irresponsibility of RMIT University in Melbourne who offer a Bachelor of Health Science in chiropractic. RMIT run their own children’s clinic using techniques medical experts have likened to child abuse. This welcome condemnation reported in the BMJ came in support of a submission to federal health minister Nicola Roxon urging her to shut the clinic down. It was authored by former Australian Skeptic of the year, successful activist against useless and risky treatments, and vocal chiropractic critic, Loretta Marron.

The submission cited the no-nonsense opinion of David Colquhoun, professor of pharmacology at University College in London. He notes the “principles of chiropractics are no better than witchcraft” insisting that the “idea that just about any disease originates from some problem in the spine is pure rubbish”. Ian Frazer and John Dwyer were among eleven scientists who put their name to Loretta’s submission. Marron has also noted the bizarre claim by some that they can treat ADHD. Later I list articles in which astonishing claims about addiction, compulsive disorders and hyperactivity all stemming from a single successfully treatable chiropractic phenomenon are made.

Reggars was scathing toward RMIT’s teaching of pseudoscience to chiropractic students. Reggars was also highly critical of the Chiropractors’ Association of Australia – the CAA. Correctly pointing out how the CAA had abandoned science for fundamentalist ideologies, he wrote that the “all-encompassing alternative system of healthcare is both misguided and irrational”.

Quoting the article, Paul Smith wrote;

“Chiropractic trade publications and so-called educational seminar promotion material often abound with advertisements of how practitioners can effectively sell the vertebral subluxation complex to an ignorant public,” Mr Reggars said.

“Phrases such as ‘double your income’, ‘attract new patients’ and ‘keep your patients longer in care’, are common enticements for chiropractors to attend technique and practice management seminars.” Mr Reggars, who stressed his support for the “mainstream majority”in the profession, also condemned the use of care contracts, where patients signed up to a fixed number of treatment sessions.

“Selling such concepts as lifetime chiropractic care, the use of contracts of care, the misuse of diagnostic equipment such as thermography and surface electromyography and the X-raying of every new patient, all contribute to our poor reputation, public distrust and official complaints.”

“For the true believer, the naive practitioner or undergraduate chiropractic student who accepts in good faith the propaganda and pseudoscience peddled by the VSC teachers, mentors and professional organisations, the result is the same, a sense of belonging and an unshakable and unwavering faith in their ideology.”


An example of the preemptive fear mongering and pseudoscientific “scientician” jargon can be found in this Australian Family article, Building Brain Power, by marketing and advertising guru Barbara Grace. Note the seamless transition from a reasonable thesis to implausibility, all the time leading to the conclusion chiropractic “treatment” alone can help. Let’s remember visual, auditory, taste and olfactory (smell) are senses with no connections to the spinal cord. If these senses were “carried by the nervous system to the spinal cord” quadriplegics would be blind, deaf and bereft of smell and taste. [Bold mine].

During a child’s early years, some children don’t progress according to developmental milestones, with delays in learning, socialisation and motor co-ordination limiting their potential…. Neuroplasticity research shows that a child’s environment shapes brain development, with all sensory perception carried via the nervous system to the spinal cord, where it is integrated into the brain’s cortical map. Helping a child achieve full potential begins early with positive environmental experiences.

‘We are sensory organisms and we develop through our sensory experiences,’ says Dr Genevieve Keating, a Melbourne pediatric chiropractor whose research into ‘how we are who we are’ underpins her work with young children. ‘The richness of our environment wires the brain and affects motor and cognitive development,’ she says.  A baby’s brain, the most immature organ at birth, continues developing as higher brain centres integrate primitive (startle, suckle) reflexes and establish postural reflexes (for movement, balance, co-ordination) as a child grows.  ‘We know that failure to integrate primitive reflexes in the normal developmental windows is a reliable predictor for further interruption to development,’ says Dr Keating.

‘Sometimes babies won’t crawl, but move along on their bottom, an action commonly known as ‘butt scooting’ or ‘bottom shuffling’. This behaviour can indicate a developmental delay. When a child puts his or her hand on the floor to assist butt-scooting, then the child is developing asymmetry in their nervous system,’ says Keating. Strong sensory and motor pathways enhance clarity of thinking, smoothness of thought and social skills. If a child has poor social development, Keating believes that often it indicates the child hasn’t yet developed maturity in their neural pathways.

‘Children with poor social development often are unable to read other people well, they’re too ‘in your face’, or they’ll be uncoordinated and bump into other children and display inappropriate reactions.’

The article then broaches plagiocephaly, the asymmetrical distortion of any skull bones. It may result from intrauterine conditions or from sleeping on the back, particularly due to SIDS awareness. It’s true that the SIDS sleeping campaign has increased the incidence of plagiocephaly. It is more than adequately treated with physiotherapy and occupational therapy (the arch nemesi of credibility poor chiropractors), sometimes requiring a customised orthopaedic band. Nonetheless, the above article misleads by selectively referring to a “recent” paper by Miller and Claren. “… published in the prestigious journal Pediatrics, showed that 39.7 per cent of babies with this condition later required an individual education plan involving speech education, physical therapy, occupational therapy or special education services.”

When you read about an unreferenced “recent paper” in such publications you may arguably be assured it isn’t. Miller and Claren were published in February 2000 – Long-Term Developmental Outcomes in Patients With Deformational Plagiocephaly. [Pediatrics, Vol 105 No. 2, Feb. 2000 doi: 10.1542/peds.105.2.e26 ]. Miller and Claren are also cited frequently in physiotherapy journals, and I stress again the important clinical role of physiotherapists in managing plagiocephaly. A General Practitioner or paediatrician may assist with a referral to a physiotherapist skilled in this area. The most important point is do not ever subject your children to the pseudoscience of chiropractic. Dangerous advice given by chiropractors, specific to plagiocephaly, is to sleep babies prone. This is in direct contravention to the SIDS safe sleeping campaign. A far safer approach is to increase “tummy time” when babies are awake and can be monitored.

The harvesting of research and the cherry picking of data by chiropractors is designed to convey a fear of brain dysfunction, as if the brain has been adversely effected by skull shape. In fact the paper is describing routine occupational, speech or physical therapy. As the bones begin to reshape, babies are beginning to vocalise. With cheek and jaw bones moving into place it’s vital that the bad habits or coping techniques previously learned are not carried into the phase of speech development. But why not forget that, take a swipe at conventional medicine and praise the magic of the paediatric chiropractor instead?

Many medical practitioners, including GPs and pediatricians, assume a ‘watch and wait’ procedure when parents express concern over their child’s development, which without intervention can delay a child’s development by up to a year and seriously impact on ability to learn.

Dr Sharon Pedersen-Jones, a chiropractor on the Bellarine Peninsula agrees. ‘Once we assess a child and begin adjustments, parents often report an improvement to their child’s literacy skills and attention span as pressure is released from nerves in the neck. This release allows for optimal brain communication, which can improve a child’s concentration and overall energy levels.‘

Or as Professor Jenny Couper said above, 70% of people will report favourably with no evidence of any change. There’s ample nonsense here, but I found the appalling distortion of the development of proprioceptive attenuation almost hilarious. As children grow it takes time for the growing body to be properly represented in the sensory motor cortex. The constant feedback on joint and limb position is accurate but the fact it represents a changing limb part is a catch up duty for the brain. Tripping over feet or miscalculating leg length is simply a part of growing up. In Building Brain Power, we read;

Petersen also comments that while stumbles and falls are a natural part of childhood, ‘the body’s pain receptors don’t fully mature until 16 years of age, meaning the body will adapt if there’s been a shift in a bone’s position.

‘This is why spinal problems often go unnoticed in children. Pain often presents when a child is older, hosting problems developed much earlier in their lives.’

It seems a pattern for these arguably unconscionable con artists is to turn routine everyday normality into pseudo-pathology, whilst misinforming the public and undermining conventional medicine. A visit to the one stop chiro’ shop however will work like magic.

Not much is beyond them. Addiction treatment has been redefined years ago as “Reward Deficiency Syndrome”. A truly spectacular abuse of the neuropharmaco-kinetics and dynamics of the nucleus accumbens aka the “drug pleasure reward system”. The Chiropractic Journal once reported a Discovery Channel documentary on the topic.

The Brain Reward Cascade and RDS explain how persons can manifest a deficiency in their state of well-being, which interferes in their potential and quality of life. This work was eventually published in the Journal of Psychoactive Drugs….. Although RDS is estimated to be as high as 30% of the general population, persons suffering from addiction best represent RDS, as RDS is responsible for most addictions and compulsive disorders. The five addictions include work, eating disorders, sex, gambling and drugs. Compulsive disorders include Attention Deficit Disorder, ADHD and Tourette’s Syndrome.

Eh Gads! Almost a one in three chance of having RDS which is best represented by “persons suffering from addiction”. You could already have it! And what type of parent would take those risks? Drugs, sex, gambling, food and work. Or porn as we see below. Probably Gonzo Porn. Could you imagine what would happen if Gail Dines found out about this!? Hooley Dooley, a 30% chance of being addicted to the horrors of entwined flesh, bottom spanking, appalling music and lack luster plot lines.

Only 11 months ago Fighting Addiction With Chiropractic Care was published in Australia. In Beating Addiction – Chiropractic we read the fallacy;

In a randomized clinical trial with 98 addicts designed by Robert Duncan, Ph.D., biostatistician at the University of Miami School of Medicine, Dr. Holder found that daily chiropractic adjustments five times a week over a 30-day period increased the retention rate to 100%. “This is unheard of; it’s never happened before in addiction treatment,” Dr. Holder says. At a national average of only $40 per chiropractic adjustment, this rate of success costs only about $800 per month. Add to this $50 for a one-month’s supply of amino acids and $240-$400 a month for four addiction counseling sessions, and you have a total program cost of $1,100 to $1,250.

“This is unheard of; it’s never happened before in addiction treatment.” No kidding? And in Super Healthy, we read about “Super Recovery”. This guy kinda goes off the rails somehow, even squeezing in autism as a compulsive or addictive “behaviour”;

It could be a minister of religion gripped by an addiction to online pornography; it could be a housewife who covers her emotional and physical pain with prescription and over-the counter pain and anti-depressant pills….

Could Reward Deficiency Syndrome (RDS) be the common psychological thread that links a myriad of compulsive and addictive behaviors? What single trait is shared by… addiction to drugs (be they alcohol, cocaine, heroin, marijuana, or cigarettes); sugar and carbohydrate bingeing; pathological gambling; sex-related addictions; ADHD; Tourette’s Syndrome; Autism; Anorexia and Bulimia; Being a Workaholic; Risk-taking behaviors; and even many of the compulsive disorders?

In 2008 lacking evidence to support the claim of ability to treat colic – something science writer Simon Singh referred to as “bogus”, the British Chiropractic Association filed against him for libel. This rightly prompted England’s most senior judge to comment, “The opportunities to put this right have not been taken… I’m just baffled. If there is reliable evidence, why hasn’t someone published it?” He was also critical of the BCA’s inability to provide evidence of their ability to treat “childhood asthma and other ailments”.

These are exactly the claims being made by Warren Sipsis and his ilk, and I can assure readers there remains not a jot of evidence to support the notion of this lucrative one stop shop. What followed in the UK was that a full 25% of chiropractors fell under investigation for making unsubstantiated claims following the backlash from Singh supporters, the launch of Keep Libel Laws out of Science by Sense About Science and eventual dropping of the libel case against Simon Singh.

A major problem in Australia remains our toothless Therapeutic Goods Administration. Rubbish treatments and phoney diagnostic aids are approved on a risk basis – not an efficacy basis. This sees tricks like “crystal therapy” rated in the highest class for heart valve failure, electrical field treatment second and evidence based surgical replacement rated three categories on in the lowest. Therein lies another issue with sham treatments – the exploitation of practitioner and “patient” gullibility. Sipser has paid a small fortune no doubt, effectively for a “Machine that goes ‘Bing'” – used to fool the medical administrator in Monty Pythons The Meaning of Life. Fortunately The Weekend Australian captures the “sciencey” calming of intuition perfectly;

[Sipsers’ wellness practice has an] Insight Subluxation Station, which Sipser uses to diagnose patients. It employs surface electromyography (EMG) to detect electrical impulses in muscles, along with information on heart-rate and temperature which is fed through a computer to produce a chiropractic diagnosis. “It measures how much activity is in the muscles, and the thermal reading measures activity in the autonomic nervous system,” explains Sipser. “It shows how the nervous system is communicating with the organs.”

Reggars believes this is absolute nonsense. “Surface electromyography as typically used by chiropractors is just a gimmick and sales tool to encourage people to have chiropractic care,” he says. There is absolutely no evidence that surface EMG yields any information about internal organs, says Reggars, an opinion shared by Sydney University’s co-ordinator of musculoskeletal physiotherapy, Andrew Leaver. “I don’t know of any research that has even looked at the link between EMG results and organ pathology,” says Leaver.

For a parent concerned about her child’s health, however, watching the computer-screen’s horizontal graph-lines turn from dangerous black to benign white is reassuringly scientific. “I do like it because it’s something black and white, you can see the changes in the body,” says Liz van der Slot, whose children receive an EMG every six months.

Warren Sipser’s arrogance however, shows through in his dismissal of Reggars evidence based stance and focus on musculoskeletal problems. “That’s a very small part of the profession and they sometimes get publicity because controversy sells newspapers and television shows,” he says. “In truth, their numbers are so small that we can’t gauge what effect they are having”, he says. It’s a pity the same cannot be said about pseudoscientists like paediatric chiropractors. I’ve little doubt there are many like Sipser, and if the ranting of my anti-vaccination interlocutors is any sign as to how they cling to their demonstrably false beliefs there’s a genuine malignancy in Australian public health.

Ultimately there must be concerted efforts to complain about and deconstruct the false claims and grand promises of this fundamentalist new age money spinning hanky panky. It appeals directly to the “worried well” and insults collective intelligence by attacking conventional medicine. There’s no nice way to put it, but a great many chiropractors are perhaps liars and charlatans who make it up as they go. Others are sincerely misled with a high risk tendency to draw conclusions where there can be none. From a health care standing they are all to medicine what theologians are to astrophysics.

Finally the ball as ever is in our regulators court. The TGA must enforce much stricter standards on fake diagnostic tools and supplements that adorn chiropractor reception areas. The federal health portfolio must seek to take away as much rubbish, as it does add and reinforce genuine services.

Perhaps however, the greatest impact will come from science advocates, skeptics and mainstream medical activists using social media and large scale networking to call this scam to account.

Rachael Dunlop talks homeopathy

Dr. Rachael Dunlop, Vice President of Australian Skeptics, chats on 4MK about homeopathy in Australia [approx 11min].

Rachael touches on the harm caused by homeopathy – the denial of evidence based medicine. Specifically, baby Gloria Thomas and Penelope Dingle – wife of the unimaginably unethical Dr. Peter Dingle.

Dingle, a professional “toxin” fear monger made a pact with a homeopath to write a book about the hoped for “cure”, gambling with his wife’s life. Feel free to read the inquest below. Page 40 begins the evidence and demolition of the lies of homeopath Francine Scrayen. The bald faced lying of Dingle himself begins on page 61. The brutality of the pairs callousness defies description. The State Coroner of Western Australia dismisses the veracity of both their testimonies.

It’s true that Penelope believed homeopathy would work. Yet, the decision to save her and follow medical advice was refuted by Peter Dingle and Scrayen time and again. Soon to be on ABC’s Australian Story – watch promo. Below that is a confronting video on baby Gloria, who died of eczema after her parents dismissed medical advice or failed to follow through. They were jailed for manslaughter.

What’s The harm: Gloria Thomas Sam

“Diet-aid firm’s law suit halts review of it’s ‘outlandish’ ads”

© Louise Hall at Fairfax writes:

An academic who complained to health authorities about a company that marketed a herbal spray as ”the most effective slimming solution available in the world today” has failed to have an $800,000 defamation case thrown out.
Ken Harvey, an adjunct senior lecturer at La Trobe University in Melbourne and a regular campaigner against non-scientific products and services, has accused SensaSlim of stymying an investigation by the Therapeutic Goods Administration into its weight-loss product by launching legal action in the NSW Supreme Court.
The TGA’s complaints resolution panel had received a number of complaints about the product, including those from Dr Harvey and Professor Lesley Campbell, from the St Vincent’s Hospital diabetes centre, alleging that SensaSlim has made outlandish claims without scientifically acceptable evidence.
However, the panel is restrained from investigating the product while legal proceedings are under way.
”By having a legal case, they have totally stopped the complaint panel for at least a year but they can continue promoting and selling it and they are laughing all the way to the bank,” Dr Harvey said.
Terry Harrison, SensaSlim’s legal adviser, denied it was designed to ”gag” Dr Harvey, and said it was a response to his complaint on http://www.auspharmacist .net.au. ”He’s trying to suggest this is some sort of gag order. Nothing can be further from the truth,” Mr Harrison said.
But in a newsletter to SensaSlim franchisees obtained by the Herald, a company spokesman, Adam Adams, said its lawyers had ”found a way to defend the company”.
”This defamation action, which could be in the courts for a year or two or even longer, basically gives an iron-clad protection that nobody can raise a complaint against SensaSlim to the [complaints resolution panel] and hurt us,” Mr Adams said.

Continue reading

Beware The Lure Of New Treatments

Originally published, June 14th © MJA Insight by John Dixon.

Associate Professor John Dixon is an NHMRC Senior Research Fellow in obesity research at the Baker IDI Heart and Diabetes Institute, Melbourne, and head of the obesity research unit, Department of General Practice, Monash University, Melbourne.

The excitement of being able to participate or even lead in the development of new treatments in difficult areas such as obesity, cancer prevention and treatment, arthritis and back pain is enticing.
Unfortunately for medical practitioners, there are business entrepreneurs ready to trade on their genuine enthusiasm and – dare I say – naivety. A recent example involves weight loss. It’s not easy to lose weight and even harder to keep it off. Motivation, willpower, energy in and energy out – it sounds so simple but it isn’t.
We now know weight and fat stores are carefully regulated by powerful physiological mechanisms that actually defend against permanent weight loss – all understandable when we consider that our body computes weight loss as a signal of starvation, famine and death.
With the failure of the pharmaceutical companies to develop acceptably safe medications in this difficult area, we are left with an enormous vacuum and a huge untapped market of people who want to lose weight. The field is fertile for the “scam” professionals and complementary medicines are an easy target.
As medical practitioners we can become unwittingly entrapped in these scams. We too want to believe someone has finally developed an effective remedy.
A recent example involved a mouth spray, launched onto the Australian market with great fanfare. There were statements of massive randomised controlled trials (RCTs) with exceptional results – results that those of us in the know would think were “too good to be true”.
How could this large, multicentre RCT involving thousands of people globally have not come to our attention? A prominent European weight loss physician was engaged as a consultant by the manufacturers/promoters with the promise of the trial data being supplied.
In the meantime, this physician’s name was widely used to support the claims, giving the appearance of expert validation, which aided promotion. However, the data to support the claims was never supplied, leaving the physician high and dry with his reputation damaged.
By the time the penny finally dropped he was in an uncomfortable position as the promoters had changed from being soft and appreciative to being aggressive, confrontational and threatening. This particular matter is heading for a legal resolution.
An Australian medical practitioner, concerned about the extraordinary claims being made about this product, openly questioned the results and advised the Australian Therapeutic Goods Administration of his concerns. He was also met with aggressive, confrontational behaviour and legal action by the same promoters.
This intimidatory modus operandi is often used by the unscrupulous to suppress the squeaky wheel and delay the appropriate assessment by regulators. Meanwhile, the income rolls in and by the time the dust settles the original product has had its day and the next scam is already up and running.
This practice is not restricted to weight loss. Wherever there are regulatory grey zones, for example complementary and traditional medicines, and cosmetics, unwary consumers and medical practitioners are at risk of being exposed to unscrupulous operators.
Beware the company that delays provision of quality data, or becomes defensive or aggressive, or attempts to turn the table of blame back on practitioners who push for answers and evidence.
It takes a very strong practitioner to weather this storm but protecting the wellbeing of Australian health consumers from expensive and potentially dangerous scams makes it worthwhile.

A health product activist in court and a regulatory body in question

As Ken Harvey’s defamation hearing has begun it’s quite proper to ask questions about the impotent regulations that led to this point.
Source of article, “Prominent Activist In Court Dispute” – © Pharmainfocus July 13th, 2011 (ABC links added)
By Niamh Mullen
A defamation action against prominent activist Ken Harvey relating to a TGA complaint he made about a complementary product is scheduled for a hearing the Supreme Court of NSW today [Monday 13th].
Dr Harvey, a lecturer at La Trobe University in Melbourne, hopes to have the case taken by SensaSlim Australia thrown out. In March he submitted a complaint about the promotion of the weight-loss spray SensaSlim to the Complaints Resolution Panel, the TGA, and the Australian Competition and Consumer Commission (ACCC).
In April, the defamation action was launched. The defamatory imputations concern details of the complaint he lodged with the TGA and a report of the complaint that was published on the pharmacy news website
Auspharmacist.net.au. A Therapeutic Goods Regulation, called 42ZCAJ, means the TGA has had to stop all investigation of the complaint until the court proceedings have been finalised.
Dr Harvey has said this regulation provides an incentive to a sponsor that is being complained about to initiate a legal action. “They can drag out a court complaint; it can be very expensive for a complainant and often the complainants roll over because they can’t afford to continue the litigation. It’s a very fraught area and it’s not surprising that there aren’t many complaints,” he said on the ABC Radio National show, The Health Report. [MP3 here]. Dr Harvey said it illustrated the failings of the current regulatory system for complementary products. He pointed out that four months after a first complaint was submitted, promotion of the product continued. He said the regulators appeared to be “paper tigers”. He also said the case showed that making complaints to the appropriate authorities was not without risk.
Ken Harvey’s observations with problems about current legislation were;
Some sponsors have actually sued people who have put in complaints with what we call slap writs, strategic litigation against public participation. This can be a litigation which asks for example a stay of a report into these problems or into complaints on the grounds that this information is alleged to be defamatory. In practice what happens is that that stops the complaint resolution panel from hearing complaints because there is an obscure therapeutic goods regulation which says that if after a complaint has been made to a panel a proceeding begins in a court about the subject matter of a complaint the panel cannot deal with the complaint until the proceeding is finally disposed of.
Now that provides a lovely incentive to a sponsor that is being complained about to initiate a legal action which then stops the complaint, lets them continue to market and away they go. And of course they can drag out a court complaint; it can be very expensive for a complainant and often the complainant’s role over because they can’t afford to continue the litigation. It’s a very fraught area and it’s not surprising that there aren’t many complaints.
More so, a survey by the National Prescribing Service showed that 50% of Aussies assume complimentary medicines are independently tested. That means by a third party serving only to provide impartial results. Results that would rightly influence TGA decisions on what makes it to market in a lucrative multi-billion dollar industry. 70% of Aussies use a complimentary medicine at some point. That’s a large number but it’s a static figure. What concerns me is that some people use certain Complimentary and Alternative Medicines – CAM’s – regularly. Some of these, ensconced in the false believe that “natural” medicines are incapable of causing serious harm – if any – consume excessive amounts.
Interestingly, as can be seen below, the TGA does require, and reinforce, that manufacturers clearly label what is in the packaging. To list components of CAM’s. This satisfies TGA requirements that only ingredients on a TGA approved list are present, and accounted for. Some manufacturers go to great lengths to add some pizzazz by ambitiously qualifying what each ingredient supposedly does. You may have read these: “Each tablet/capsule/spoonful/dose contains 30 mg of xxx for added vitality, 43mg of diddlie dee to promote rapid wound healing, 12 mg of trala trala to assist in quality sleep… strong tissues, healthy bones, optimal nutrient uptake, sustained energy, immune integrity”, and so on. They do not have to advise that no independent clinical tests exist.
That means manufacturers of CAM can legally fail to inform the 50% of consumers under the impression of safe and effective testing that they are mistaken. As I’ve mentioned before, in such situations consumers are placing trust in the equivalent of a slogan.
In this light one may reasonably ask what is required to bring a product to market. In other words, how does a company successfully register their product on the Australian register of therapeutic goods to the satisfaction of the TGA prior to selling under the above conditions? Ken Harvey told ABC’s Joel Werner;
They’ve got to show that they are producing them in terms of good manufacturing practice standards. Secondly they’ve got to choose their ingredients from what is a relatively limited list held by the Therapeutic Goods Administration of ingredients they regard as relatively safe. Some sponsors regard this as a bit of a game, so if the ingredients for example in their product don’t happen to be on the list of the TGA you can happily tick whatever you find on a drop down list that you think is similar and the product will get up. And indeed recent audits from the TGA have found that up to 90% of violations when they actually sit down and get a human being to look at what’s been put into the automated system, the advantages from the manufacturers’ or sponsors’ point of view it is very easy to get these products to market.
The sponsor is meant to tick a box to say they hold evidence that the products work. When one checks up and looks at the scientific evidence it’s often very lacking for the claims that are made. The TGA do a limited amount of post-marketing surveillance in which they randomly look at products that have been listed. Those are the ones that they’ve been finding up to 90% violations. The only other constraint is people who put in complaints about complementary medicines and that system has got problems also.
Back to Niamh Mullen;
Also speaking on The Health Report, [a week laterMP3 here] the TGA’s National Manager, Rohan Hammett, said he was not aware that any individual had ever been subject to court action as a result of simply complaining through the usual complaints resolution processes. He also said it was normal practice for administrative proceedings to be put on hold when a higher court was considering a matter.
“Many of the complaints that actually arise about therapeutic products arise between commercial competitors. So one company may complain about another company’s advertising to seek to gain commercial advantage from that and hence there are processes in place that lay out clearly the steps for making an effective complaint. But also, where there are matters for courts to decide, they allow those courts to make those decisions and I think that’s actually an appropriate way for our legal system to operate,” Dr Hammett said.
That particular episode of The Health Report opens with a comment on TGA figures showing 9 out of 10 CAM products breach regulations in some way, with 22% unable to provide the evidence of efficacy they claimed existed. TGA national manager, Rohan Hammett sounded quite the apologist in saying;
Well Joel the data that we released on Friday is the sort of data that we’re hoping to make more available in the future to people about the compliance activities that the TGA undertakes. And these data do raise significant concerns about the current rates of compliance amongst the complementary medicine sector. I have to say though Joel, just to perhaps provide some context to that, many of the breaches in the compliance are of a relatively minor nature, people may for instance be using the wrong size font on a package of their complementary medicines in breach of a guideline that says the font has to be a certain size.
Or they may in fact have a document missing from their application. That is technically a breach but actually doesn’t affect the quality of the product in any way.
Somehow I don’t think consumers are worried that boasts of Xmg of diddlie dee providing strong bones or an aid to concentration may be written (aptly I might add) in large Comic Sans and not properly sized Ariel font. No, I’m pretty sure the 22% evidence vacuum trumps not having to fumble for ones glasses to read bollocks.
To put that in perspective, a large warehouse type chemist I visited had a CAM aisle easily 25 metres long. With shelves on both sides that’s 5 metres of products that do not have evidence backing the claims adorning their labels. In major suburban pharmacies one in five of those splendidly displayed products cannot be trusted.
There are demonstrably many benefits to Ken Harvey taking the actions he has over this unusual failure to regulate in the interests of community safety. To get a feel for the apathy and impotence of the TGA compare these two comments from different Health Report episodes. On May 16th Ken Harvey stated;
….. Why hasn’t anything happened? Well clearly I think there are two reasons. Firstly the complementary medicine industry is very reluctant to have anything happen because they are making good money doing what they’re doing. And the second problem I think is the Therapeutic Goods Administration. It’s a risk-based organisation, it can only put its limited resources where it thinks the big problems are and it would regard ripping off consumers as less of a problem than for example some prescription medicines which have really nasty side effects which can kill you.
However, not concentrating at all on the problem of complementary medicines has let the problem blow out. I might say there’s one other problem that people have perceived and that is that the TGA is 100% funded now by industry fees and again some people have unkindly suggested that if you’ve got an organisation 100% funded by industry that it may be more reluctant to take measures that would impact on industry profitability and indeed on the TGA’s own finances.
The following week this was brought to the attention of Rohan Hammett. He responded with spin;
Well Joel with respect to Dr Harvey those claims are absolute nonsense. The TGA is an organisation established by the Australian government to fulfil a public health role. I get up every day as do the other 600 employees here to improve public health in this country by making sure that people have access to safe and effective therapeutic products in a timely manner.
The fact that the industry has to pay fees to recover the cost of that regulation is a common practice across Commonwealth regulatory agencies. That removes the burden of the costs of that regulation from the tax payer. Why should the tax payer have to fund the regulatory costs for a commercial sector that is then going to generate profits from that regulation?
So just to emphasise that the TGA’s key stakeholders are clearly the Australian people and that is who we work for and our role is very much to provide public health benefits for them.
So to be clear, the TGA is most certainly 100% funded by the industry that’s failing to adhere to regulations. What Hammett thinks is nonsense is that this situation influences the capacity of the TGA to act with impartial conviction. He perhaps should have stopped there. The rest of his commentary appears to be special pleading.
In fact, the burden of proof is of course on the TGA to show that it’s present funding source is not a conflict of interest. That in my mind has not been done.