© Louise Hall at Fairfax writes:
Category Archives: Health
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 later – MP3 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.
Progressive policy and fundamentalist resistence
A close look at the rejection of evidence and application of religious belief as guiding principles for members of the Negative team, in debating if drugs should be legalised. Jade Lewis, Greg Pike and Paul Sheehan.
Last post we looked at the debate All drugs should be legalised held by Intelligence Squared. One of the greatest moral, social and human rights based questions today is: Should illicit drugs be legalised?
We ask this question because the harm caused at the community and personal level by prohibition is irrefutable. To this we can add the devastating effects of The War On Drugs – crafted initially by Nixon on the back of the Vietnam war. Few realise the first head of the US Drug Enforcement Administration had his office in Saigon. Returning veterans had to produce clean urine to show they were not using heroin.
Once begun, this foreign policy bonanza worked much like Dr. Whoʼs “psychic paper” pass. Flash it at a sentry and they read whatever convinces them of ones legitimacy. But more so was the USAʼs powerful control over the UNODCP and hence, UN drug policy. Most in the Western world have knowledge of Harm Reduction. The acceptance that punitive measures for drug users ultimately inflicts personal, monetary and social cost on the wider community, and accepting use whilst minimising harm reaps benefits for all.
For this reason nations who focus on evidence and the international right to health provide clean needles through NSPʼs – needle and syringe programmeʼs. Safe injecting facilities are provided increasingly in Europe and elsewhere. Australia has over 1,000 NSPʼs and one Medically Supervised Injecting Facility – MSIC – in Kings Cross, Sydney.
These programmeʼs and facilities serve to manage high risk behaviour, control the spread of blood borne viruses, motivate/provide for users to seek treatment, and they meet community discontent arising from obvious illicit drug use. Most users can return to work, pay taxes, raise a family and remain healthy. But what of intractable addiction? More recently several heroin on prescription schemes in Europe have shown dramatic results in reducing crime, death/illness, uptake of heroin use and length of heroin addiction. Portugal has full decriminalisation and demonstrates a resounding success to date.
Once world leaders in harm reduction, Australia was ready to be the first nation since the War On Drugs began to introduce a heroin on prescription trial in 1997. Despite State government sanction of 6-3, John Howard personally intervened to stop this, and weʼve been backsliding ever since. The rise of Christian Evangelical lobbyists has caused bemusement, angst and disgust.
Australiaʼs full policy is Harm Minimisation – HM. Supply reduction, demand reduction and harm reduction. Zero Tolerance has only ever been rhetoric. Harm reduction is the least funded, with the struggle to repel supply and the education and (usually failed) advertisements thrust at young Australianʼs taking the two highest shares respectively.
Those who resist drug legalisation seek to distort the argument by misrepresenting the success of harm minimisation. Indeed despite overall reduction in drug use they fraudulently and falsely argue that HM encourages, condones, increases or has no positive effect on use. Attacks on successful initiatives with peacock terminology and weasel worded opinion pieces are common. Published as “research” these are brought up time and again.
In the case of Drug Free Australiaʼs Case For Closure [PDF] against the MSIC, written during itʼs trial status, it is simply rehashed, republished and recirculated. One speaker, Greg Pike is co-author and “statistical analyst”. Greg is best known from his role as Director of the Southern Cross Bioethics Institute, which presently promotes his part in the upcoming debate. Another co-author is the infamous “naltrexone fatality” doctor, Stuart Reece. Embattled DFA secretary Gary Christian is another.
You may wonder why, if supply and demand reduction are funded more than harm reduction, that such groups attack harm reduction – HR. My psychological profiling days may be behind me, but this is clear. HR already attracts right wing condemnation and is easy to misrepresent. The evil druggie and his/her filthy lifestyle is a false pop culture phenomenon. However, conservative Christians cast HR in pop culture format usually in the context of blaming HM. Enter the suggestion of why we need demand reduction. Young Aussies take drugs. Kids from all walks of life. From all faith backgrounds.
For the religiously conservative mind this is an affront. An insult to parenting skills, the instillation of Christian values and indeed, Godʼs work. God “cures” addiction. He does not leave vacuums of vulnerability, in the mind of the fundamentalist. Thus HM in totality is an affront to conservative Christians. Overlaying this is the fear of the success of HR education. An analogue of sex education and condom availability, no proper child would fail to just say no to sex and drugs – or rock n roll for that matter. With two down, supply reduction must be increased along with punitive measures for users. And DFA are adamant they speak for “all Australians”, promoting behaviour control: Harm Prevention.
Another speaker and DFA identity – whose intentions I kind of understand – Jade Lewis wants a drug free Australia, [surprise!] through application of biblical values and the never ending sale of her “story” on DVD. Not your story, or the story of drug policy, or evidence based material – her amazing religious conversion. Jade is ruthlessly exploited by DFA. The excessively priced, only-seen-if-you-buy-it DVD, “Golden Haze” earned Jade the title “The goose that laid the golden haze” – (more on Jade later).
Greg Pike
Greg is co-author of the Case for Closure and a crusader against humane or progressive policy and free choice. His “bioethics institute” gig is a misleading peacock in some of today’s most pressing health issues. Abortion to him is of course, murder and at one time he claimed – as a research outcome – most women do not want choice. His argument against euthanasia once included the appalling claim that a patient travelled to Switzerland – with others – to die with dignity, as “… a case of someone wanting to pursue death under activist like circumstances.” [ABC 7:30 Report Feb. 2007].
Greg Pike
The right to die for the terminally ill is supported by as many as 85% of Aussies according to some polls. The reluctance of politicians shows the grip of the Australian Christian Lobby on vote wary parties. Prior to the above debacle, Pike wrote “Once the killing starts, there’s no stopping it” in January 2007. It included;
All Drugs Should Be Legalised – Intelligence Squared Debate
On May 10th this year Intelligence Squared – the forum for live debate – hosted All Drugs Should Be Legalised in Sydney Australia.
You can watch the video alone here, or check out the audio here. They note on their website.
In most cases, prohibition has failed to curb demand and the provision of illicit drugs has become the lucrative trade of organised crime – with the associated ills of corruption, violence and health risks.
Some people urge tighter restrictions on all recreational drugs as the cure for social ills linked to their use and abuse. Others argue that all drugs should be legal – subject only to prudent regulation.
Below are the pre and post debate audience figures for All drugs should be legalised.
| Question | Pre-debate poll | Post-debate poll |
|---|---|---|
| For: | 46.8% | 69% |
| Undecided: | 32.3% | 8% |
| Against: | 20.9% | 23% |
Well prior to this debate, I was struck (to put it mildly) at the makeup of the negative team. Decorated veterans from The Enemies of Reason army, I felt more disappointment than the outrage I expected would engulf me. It was clear those bastions of moral evangelism and anti-drug hysteria, Drug Free Australia had quite likely been called upon to muster a good riposte to the ever expanding evidence supporting a change in policy. Like calling upon conspiracy theorist and anti-vaccination lobbyist Meryl Dorey of the AVN for “balance” one can rest assured DFA, enamored with pseudoscience, could fill the anti-drug niche. For “balance” if you like.
My next post will be my own biography of the negative team. These guys have a lot in common and I feel it’s only just to point out the “incestuous” relationship that manifests as informed opinion, but is in fact a superstitious, narrow and morality based attack on secular Australia, progressive policy, free thought, free choice, human rights and individuality. Yet my disappointment in “releasing the hounds”, so to speak stems from the fact I myself can argue against legalisation for reasons never mentioned here. Yet they tend to be reasons on variations of legality and access. Or concerns over black markets. Or solutions proffered by other pro legalisation movements. Australia is unique. Great arguments come from Norm Stamper and his colleagues at LEAP – Law Enforcement Against Prohibition. But we don’t have shoot outs in suburban streets and thankfully, haven’t tortured and jailed our civilians at the rate the USA has. We already have Harm Reduction – we just need more. Period.
The negative team is:
Jade Lewis is a former drug addict who now campaigns and educates against use of illegal drugs. As a young teenager she was a champion junior athlete who competed internationally, and won the WA Doug Hancy Award, Athlete of the Year and Junior Sportswoman of the Year. Her records remain unbeaten in Western Australia. Her later heroin addiction, criminal behaviour and volatile relationships are recorded in her book, Golden Haze. She now educates at schools on positive relationships and runs a program for women prisoners.
Dr Greg Pike is the Director of the Southern Cross Bioethics Institute in Adelaide, South Australia where he focuses primarily on the influence of bioethics on public policy development. He trained as a physiologist with a PhD in muscle electrophysiology, becoming Hospital Research Scientist at the Royal Adelaide Hospital in the Department of Surgery. He is the Chairman of the Board of the Australian Drug Treatment and Rehabilitation Program and a member of the Institute on Global Drug Policy, has served as a Deputy Member on the SA Council on Reproductive Technology and was a member of the Australian Health Ethics Committee for the 2006-09 triennium.
Paul Sheehan is one of the most thought-provoking commentators in Australia today. A columnist for The Sydney Morning Herald, Sheehan is a prominent writer and has written on the bigger debate about the politics of cultural diversity in contemporary Australia. He is one of Australia’s best-selling authors with three best-selling books including, most recently, the number-one best-seller, Girls Like You.
The positive team is:
Nicholas Cowdery AM QC BA LLB was the NSW Director of Public Prosecutions running the largest prosecuting agency in Australia from 1994 to 2011. He became a Barrister in 1971 and was Public Defender in Papua New Guinea for four years. As a Barrister in private practice in Sydney, he specialised in criminal law appearing in many high profile cases including the prosecutions of the late Justice Lionel Murphy (of the High Court of Australia) and of the late Sir Joh Bjelke-Petersen (former Premier of the State of Queensland). He is a member of the NSW Sentencing Council and the Advisory Committee, Sydney Institute of Criminology and the National Advisory Committee, Centre for Transnational Crime Prevention, University of Wollongong. He is the author of Getting Justice Wrong: myths, media and crime.
Wendy Harmer is a prominent Australian broadcaster, entertainer and veteran of countless international comedy festivals. She has presented top-rating morning radio and has hosted, written and appeared in a wide variety of TV shows including ABC’s Big Gig and In Harmer’s Way. Harmer is the author of several books for adults, two plays and a series of children’s books. She has also hosted the television Logie Awards and has been a regular newspaper and magazine contributor.
Dr Alex Wodak AM is a physician and has been Director of the Alcohol and Drug Service, St Vincent’s Hospital since 1982. His major interests include prevention of HIV among injecting drug users, treatment of drug users and drug policy reform. Dr Wodak is President of the Australian Drug Law Reform Foundation and was President of the International Harm Reduction Association (1996-2004). He helped establish the first needle syringe program (1986) and the first medically supervised injecting centre (1999) in Australia when both were pre-legal. Dr Wodak helped establish the National Drug and Alcohol Research Centre (1987) and the Australian needle syringe program annual survey (1995).
Losing In The Lucky Country 