At the risk of a gratuitous self-plug, the use of these medicines in young children was one of the issues of concern that Ray Moynihan and I highlighted in our book, Ten Questions You Must Ask Your Doctor (Allen & Unwin, 2008). We came across several references raising concerns about these products’ use in children when researching the book back in 2007.

So the TGA is certainly not rushing the jump.

Nonetheless, the move will be such a challenge to accepted practices that it will need to be backed by a long-term educational campaign. So argues Ron Batagol, a Pharmacy and Drug Information Consultant.

He writes:

“In a move that is likely to provoke much spirited debate amongst doctors, pharmacists and, most importantly, the parents and carers who look after the day-to-day health issues of  young children in their care, the Therapeutic Goods Administration (TGA) has given notice that it is intending to  “upschedule” over-the-counter cold and cough products to Prescription Only for children under six years and Pharmacist Only for children aged between six and 12 years.

As part of the upscheduling exercise, the TGA has also recommended cough and cold medicines should not carry dosage instructions for children under six years old. The TGA says that this approach would bring the regulation of cough and cold preparations in Australia into line with measures in place in the UK and Canada.

After extensive  internal and external reviews of the evidence surrounding both  efficacy and safety in use, the proposed changes are stated by TGA to have been made ” in light of the current lack of evidence of efficacy and the historical profile of adverse drug reactions (ADRs) in Australia and overseas”.

It is certainly true, that the  consensus of informed opinion amongst paediatricians about the usefulness and propensity of side-effects of these products is in concurrence with the TGA assessment.

Now I must say that there is a whole fascinating social phenomenon associated with parents and carers buying cough ands cold products for children in their care.

This has, in fact,  been noted in the TGA External Review, where they raise the concept of  “social medication” which researchers have found is, in part, aimed at modifying child behaviour to more acceptable patterns, and in part a ‘coping strategy, and that cough and cold medicines were a common “social medication” in this respect’. Pharmacists at the “coal face” will be very familiar with this belief amongst their clients and the associated behaviour patterns.

Presumably, in recognition of  the social behavioural re-scheduling moves would certainly make them feel to some extent disenfranchised, turning on its head as it does, a long-held, even if erroneous, understanding that recommending a suitable cough and cold product for use by children served both a therapeutic and, as discussed, also a “social” function.

It seems to me that there will need to be long-term educational campaign on this issue, if the  proposed changes are adopted.

Indeed, TGA has said that the changes recommended would need to be widely promoted and explained to medical practitioners, pharmacists, parents and caregivers, and that particular efforts be directed towards educating consumers, medical practitioners and pharmacists that OTC cough and cold medicines have not been shown to be effective, and are potentially harmful in children under 6 years of age.

From recent discussions of this issue, when I raised it on our major pharmacy internet discussion website Auspharmlist, I have no doubt that at all that education and explanation will certainly be needed for many of my pharmacist colleagues, and their professional organizations!  This is, of course, quite understandable.

After all, on the face of it, the proposed issue is somewhat analogous to the lengthy but ultimately quite successful campaign over the past 5-10 years, to “educate” doctors and inform the broader community that antibiotics are not required to treat a whole range of common infections, and may ultimately promote bacterial resistance.

Five to ten years ago, of course, patients virtually demanded an antibiotic from their doctors in such situations.  These days, most patients are aware of this or, at least, do understand the situation when it is explained to them.

But, with TGA inviting responses from  stakeholder organisations, it is going to  require a huge effort to achieve the aims of broader community understanding of the rationale for the move by TGA to restrict availability of this group of widely-used, and generally well-regarded  infant and childrens’ medicines.”

Some of the most critical comments have come from breast cancer consumer advocates - overtones, perhaps, of how prostate cancer consumer groups have sometimes reacted to evidence about the potential harms of prostate cancer screening.

Now Hazel Thornton, an independent advocate for quality in research and health care in the UK, and an Honorary Visiting Fellow, Department of Health Sciences, University of Leicester, gives us another perspective. Thornton describes herself as having being “given the breast cancer label” as the result of undergoing mammographic screening in 1991.

She writes:

“It is unsurprising that women find it hard to accept the facts from papers such as that by Stephen Morell and colleagues from the University of Sydney, and from robust systematic reviews of screening by mammography, or of breast self-examination.

Twenty years of being told what to do in paternalistic promotional literature extolling the benefits of ‘finding it early’, and being frightened by being told that ‘it could save your life’, are difficult to reverse.

As we see, many women’s support and information groups are still encouraging women to disbelieve good evidence of over-diagnosis and over-treatment. They assert that it is acceptable to accept unnecessary lumpectomies, mastectomies, radiotherapy, chemotherapy and hormonal treatments “just in case”.

Promotion and arguing that this utilitarian ethic is acceptable by those in authority is unethical and harmful: it denies those women who trust them proper respect and the right to be properly helped to make up their own minds by neutral presentation of balanced facts. For more information, see the English version leaflet that can be downloaded here.

For too long ‘The Facts’ that women have been provided, e.g. by the UK NHS Breast Screening Programme, have been short on fact, short on evidence-based data, but full of persuasion, estimates, promise of benefit – but silent about harms.

Until this year, that is, when they at last capitulated to exposure by a letter in The Times 19th February 2009 signed by 23 international experts, stating that their invitation leaflet was short on the truth and totally inadequate for the purpose of enabling women to make an informed decision about whether to attend.

Many women were and still are unaware that they have any choice in the matter – and, as Iona Heath entitled her paper in the BMJ: “It`s not wrong to say no!” (abstract is here)

Strenuous objection had repeatedly been made to informing invited women about pre-invasive cancers such as DCIS.

Yet, in the UK, on Sunday 1st November 2009 it was reported in The Sunday Times that “The Government has been forced to rewrite its advice on breast cancer screening after research showed that thousands of women have been misled into having unnecessary surgery.”

Joan Austoker (who is leading the revision of the invitation leaflet) “had admitted it had been a mistake to withhold information about unnecessary treatment for DCIS”. It was also reported that they “want to make sure that all the risks of breast screening are referred to in appropriate detail.”

Only this week, 17th November 2009, the US Preventive Task Force has published guidelines with the following recommendations: “The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take into account patient context, including the patient’s values regarding specific benefits and harms. (Grade C recommendation)” .

Quite a turnaround!

This month in the UK, Sense about Science, addressing poor public understanding about what screening can and cannot do, launched a booklet: “Making Sense of Screening”.

Little by little, reason is beginning to prevail over blind belief!”

Andrew Penman, Chief Executive Officer of Cancer Council NSW, has been considering the complexities of the issues involved, and writes:

“As a public health program, screening for breast cancer makes sense.  It reduces mortality by 30%, the cost incurred in saving a life is competitive, it reduces the number and percentage of women who present with advanced and disfiguring lesions, and opens the door to less invasive treatment options.

Given the impact of breast cancer on population health expectancy and on the lives of women affected it is understandable that there is a large and voluble group of body protagonists for breast cancer screening and their cause is justified.

The evidence that screening reveals early cancers and initiates a treatment pathways in some women who would not have needed to endure it in the absence of screening is well proven.  The size of the effect at around 1 in 4in Australian research also appears a reasonable estimate.

On reflection, it is entirely consistent with our understanding that cancer incorporates an array of neoplasia with varying degrees of biological potential.  However, as our experience of the natural history of cancer has been framed predominantly around clinically significant disease, we are be less attuned to the behaviour of cancers with lesser biological potential.

Given that participation in breast cancer screening remains suboptimal, it is natural for the advocates for screening to be defensive when any evidence to counter the claim for benefit emerges, particularly when that evidence suggest that some participants will bear a burden as a result of screening without commensurate benefit.  But no population health intervention spreads benefit and burdens equally.  If this were a requirement, we would have no immunisation programs. In mammography screening at the very least those who are never diagnosed with cancer carry the burden of participation.

The use of the term “over diagnosis” to describe the detection of cancers with limited biological potential contributes to the defensiveness of advocates for screening.  It carries with it connotations of unnecessary and self-serving medical intervention, of overzealousness with attendant disregard for participant welfare.  Advocates are at pains to downplay any information that may further erode public confidence and participation.

In reality, the detection of cancers (or pre-cancers) with limited biological potential in inherent to the screening methods for all cancers.  It is therefore misleading to represent this as “over diagnosis” with its pejorative connotations, when such detection is part and parcel of the pathway to achieving benefit at the population level as well as at the individual level for the 3 out of 4 women diagnosed.

Screening detects cancers with limited biological potential, but the way the issue is framed affects the way we and participants react.  For participants, a proposition that any lesion detected has a 75% chance of progressing to life endangering cancer is different from a proposition that there is a 25% likelihood that any diagnosis is unnecessary.

Randomised trials of decision aids that deal dispassionately with risks and benefits of screening, including “over diagnosis”, show that women who use the aids are more informed, have less decisional conflict about screening, but continue to participate in screening at the same rate as the control group women.

Screening programs have been fairly criticised for providing inadequate information on the outcomes of screening for participants.  Fears about the dangers of full and unbiased information in the hands of consumers abounds among professionals, but are almost always misplaced, as in this case.   Advocates for screening should welcome the opportunity to engage women more closely in these issues.

The value of accepting and understanding “over diagnosis” lies in how we manage the future.  As more sensitive detection methods are evaluated, the likelihood that “over diagnosis” will increase and diminish population benefit at the margin needs to be assessed.

Research to discriminate between biological potential of cancers should assume a greater priority, and perhaps we should consider trials of more limited primary treatments.  But at the moment, population screening for breast cancer is a very good buy for cancer control, and women who have been given greater opportunity to consider these issues seem to agree that it’s a good buy for them too.”

Croakey has asked a range of individuals and groups to respond, and will post their comments as they land.

Sally Crossing, AM, Chair of Cancer Voices NSW, and member of the Breast Cancer Action Group NSW, comments:

“I was almost at a loss on how to respond to the latest study about the downsides of breast mammography screening.  So I asked an informal – lets ‘fess up – quite impromptu group of women of the screening age what they thought.  Five were “well’ women of the target age group, who screened happily and regularly, two others had been diagnosed – one detected early with no further disease, the other not so lucky.

This large sample, to a women, expressed concern about the findings of Morrell et al which have given rise to much media speculation and consequent public concern.  Where does this leave us now?, they asked.

Discussion continued with the fairly quick result that none of those still screening would stop because – and here’s the rub – we have absolutely no way of knowing whether our little early detected invasive tumour is a “goodie’ or a baddie’.  Not one of those women wanted to take such a risk and could not imagine anyone wittingly doing so.  The two women who had had breast cancer diagnoses had both been detected early – one was fine, and the other not.

The “downsiders” also refer to the “harms” of breast screening.  I know those of us who are breast cancer survivors may be called biased, but we feel pretty comfortable that the “harms” of having to wait for results, perhaps having a fine needle biopsy, even a small excision – are not very major in the big picture of knowing whether you have cancer or not.

Of course, having chemotherapy is a big “harm’ – and this is where it is so important for the research community to find out how to tell if one small lump needs full bore treatment, or not.  There are shades and degrees in this discussion that were not in the ambit of the downsiders.

I notice the journal article is mainly interested in outcomes as measured by death rates.  Here’s another thing to consider – we women are mainly interested in living as long and as well as possible.  We would like to see the endpoint being years of quality life, not numbers of deaths.  And thanks to early detection and more personalised and less toxic treatments, many of us are living much longer and better with our disease.

Of course people should be given good information about any possible risks and benefits of any medical intervention, and indeed of tests like screening.  It needs to be very well accepted information, expressed in terms that are completely understandable.  I don’t think we have reached that point with these findings.

Cancer consumer advocates are concerned that studies on possible over-diagnosis due to screening may be used to restrict publicly-funded screening and undermine the message that early detection saves lives.

Could we not direct the research money which supports these studies to the elephant in the room – finding out which detected cancers will progress and which won’t? Suspicion of over-diagnosis then would not be a researchable issue.

***

Professor Ian Olver, Chief Executive Officer Cancer Council Australia, writes:

“Breast screening has been estimated to reduce mortality from breast cancer in the target population of 50 to 69 year old women by up to 35%.

One of the downsides, though is that the screening test is far from perfect and can result in overdiagnosis. There are widely ranging estimates in the literature about the extent of overdiagnosis because population modelling includes the need to make assumptions which introduces variability.

However, there is no doubt that overdiagnosis does occur, against which the decrease in death has to be balanced.Individual women need to be informed about this.

Having said that, at the individual level we cannot distinguish which of the invasive cancers diagnosed at screening will have an indolent course and need not be treated.

The first consequence of overdiagnosis is that it points out the necessity for further research into being able to detect the slow growing from the more aggressive cancers so that we can identify a group that does not need treatment.

Until that occurs, women will be advised to have treatment which could save their lives.

The participation rate in breast screening is still not ideal and women are still encouraged to have a screening mammogram in the target age group to decrease breast cancer mortality as far as possible.

It would be counterproductive if women were dissuaded from participating in what has been a successful screening program simply because overdiagnosis occurs.”

***

Terry Slevin, Cancer Council WA, writes:

“The Sydney University study is important in helping us understand better the impact of breast cancer screening – but for many of us there are few surprises. They quantify an effect we’ve known about for some time that applies to all cancer screening – not just breast cancer.

But as the resources are more available for breast cancer than most other areas of cancer – we tend to get better data earlier on breast cancer issue compared to other forms of the disease.

In simple terms – when we go systematically looking for more cancer – we are pretty much bound to find it.  It has certainly happened in prostate cancer and is likely to happen in bowel cancer with the National – albeit somewhat half baked – Bowel Cancer Screening program, where not nearly enough people are invited to participate compared to the number we believe will benefit.

The question is – can we maximise the benefit of finding more cancer early so that the “price” of finding and unnecessarily treating cancers that would have otherwise cause no harm, is justified.

And Alex Barratt is right.

Yes – we need to come up with better, more accurate tests that more precisely discriminate between the cancers that need intervention and treatment and those that can be safely left alone.  And we need to better inform those invited to screening of the benefits AND the risks.

Key to this is advancing technologies and ensuring those are thoroughly evaluated before they are marketed.  Easier said than done when many in the biotech world see the next big cancer test is the holy grail for company profits.

Another way to swing the odds in our favour is being VERY careful who we capture in the screening net, and ensuring that everyone is very clear about what they are letting themselves in for.

And all of that is achieved if we keep talking about these issues based on the highest quality research which must be communicated in a clear and accessible manner.

We need to continually weigh up what benefits we get from cancer screening and what price we pay for those benefits.

These principles apply to breast cancer screening, bowel cancer screening and the testing that is done for prostate cancer.  It is important to understand that, based on the best available evidence, most health and medical experts who I deal with agree that the benefits substantially outweigh the costs for breast and bowel cancer screening, but that case has not been proven for prostate cancer screening.

But a nice way to think about it is from a punter’s point if view.

Image you had a cancer (of the x) test today.  The test is positive.  You then undergo further examination and the presence of cancer is confirmed.  You undergo treatment.  Probably surgery, radiotherapy and chemotherapy – and all that goes with them.

In 2019, you are sitting in your comfy lounge chair at home and someone tells you that you had a one in 50 chance of having had your life saved through having had your test.  And a 49 in 50 chance of having undergone all that unnecessarily.  What would you think?  Those are the numbers for prostate cancer.

What if it was one in 10 for having saved your life versus 9 in 10 being unnecessary?

Or one in 3 verses 2 in 3 ?

Where is the cut point for regret ?

Now come back to today.  What numbers from the above scenario would influence whether you do or don’t do the test.  And you are scheduled to do the test tomorrow….

Tough huh !  But those are the challenges we face – and a big part of that is how we better communicate that story to the people we ask to make that decision.  The people we invite to be screened.”

***

Sue Lockwood, Breast Cancer Action Group Vic, writes:

Alex Barratt has been pushing the need for better information and decision aids for women undergoing screening for years.  Of course she is right, we do need to make sure that women are properly informed.  But papers such as the one she has just published giving figures for the “overdiagnosis” of breast cancer do not help inform women.

This is a straight epidemiological study which has no relevance to decisions made by individual women.    A radiologist looking at a mammogram cannot tell whether the invasive cancer he or she can see is one which will develop into full blown cancer or not.  The surgeon who removes the lump and the pathologist  who dissects it cannot distinguish one lump from another except in broad brush terms, e.g.  oestrogen receptor positive or not, Her2 positive or not and the like.  Similarly the oncologist has no real information except for the examples mentioned above.  The chemotherapy women respond to is a bit like picking the winner in the Melbourne Cup.  The main difference is that you can keep trying different horses on different courses.

The other major flaw in Barratt’s argument relates to harms.  She sees unnecessary treatment, surgery, radiotherapy, chemotherapy , and the psychological trauma of a diagnosis of breast cancer as a harm.  Of course she is right, the treatment of breast cancer can be a harm if your breast cancer is not going to progress.  But as I have argued it is impossible at the moment to determine which women are being harmed and which women are getting the correct treatment..  Most women, although they find the treatment traumatic, would see it as taking the opportunity to do as much as possible  to rid their body of breast cancer.

I have argued for many years that the greatest harm is one where breast cancer is not diagnosed correctly or in a timely fashion.  This can lead to the greatest harm of all, DEATH.  This is obviously a disaster for the woman, but also for her family.  It is a trauma several orders of magnitude bigger than the trauma of initial  treatment for breast cancer.

This research should never have been funded.  It is a complete waste of precious funds.  It has not provided any information we did not know already.  Perhaps it made the data available more accurate, but is provides absolutely no information to inform women or  to help improve treatment outcomes.

We already deceive women by providing only 5 year survival statistics.  These figures give a biased view of survival as we know that women continue to die of breast cancer over the long term, 10, 20 years after their initial diagnosis.  We would be much better off looking at how women survive their breast cancers, how many actually go on the develop advanced breast cancer, how long they live and how well they live with  advanced disease.

Please let us focus on the important research, which provides the opportunity to improve the lives of women with breast cancer.

Here she shares with Croakey readers some of the background to the book and her writing of it:

“Flying with Paper Wings is a story of survival. It begins in Ballarat of the 1950s and 60s with painful childhood memories. Sitting in my mind’s eye is the image of my drunken mother, slumped in the passage, bruised and battered, after a beating from my raging father.

Although I shared with my older brother and sister the fear that one day my father would kill my mother, or that she would commit suicide as she so often threatened, the three of us rarely spoke of the constant horror, never daring to share it in or outside our small Ballarat home.

After leaving home, I stumbled through university, graduating in 1975, only to be diagnosed with schizophrenia in 1976.

My fall into madness was catastrophic. Suddenly the person I thought I was became a stranger. With each psychotic episode I went further into the mire of madness. Depression also held me in its sway.

My struggle with madness has been long and arduous. Flying with Paper Wings documents this in detail. My poetry has been a potent force in countering the debilitating effects of my schizophrenia.

In writing about my madness, I have turned disaster into celebration. Poetry gave me back an identity which had been stripped away with the onset of my schizophrenia. The book is also a celebration of friendship.

A decade ago, I decided to retrieve the records of my admissions to mental institutions. It prompted me to begin writing my story – of being drawn into the underworld of madness and returning to tell the tale.

In its telling, I seek self-understanding, but also to discover to what extent nature or nurture are implicated in my  illness, how an ill-formed and fracturing identity can be rebuilt, and how, as a society, we might better treat the mentally ill.

This was a painful and confronting book to write because to see my life on the page, warts and all, left me wondering: why have I revealed so much of myself?

We all have our story to tell and perhaps by me telling my story someone else may be inspired to tell their story too. I wrote the book because I wanted to understand better the life events that have shaped me; to trawl the foul, murky world of my voices; to understand my wildly fanciful delusions.

At the heart of the book is the little girl who watched her parents fight; who experienced her own sexual assault; who left home with a hope for a better life, who flirted with Catholicism to nourish her soul; who fell into the dungeons of madness – she is desperately trying to make sense of these huge life events.

Melbourne writer, Helen Elliot, describes Flying with Paper Wings as ‘anything but a misery memoir. Glittering with black humour and without self-pity, it shifts other people’s perceptions of mental distress beyond kindness, compassion, sympathy and fear into some deeper perception.’”

Flying with Paper Wings is published by Vulgar Press and can be bought from Sane Australia ($33) by visiting here or by ringing 03 9682 5933. It has been warmly endorsed by Anne Deveson and Andrew Denton.

“We don’t want people to panic,” Dr Otis Brawley, the Society’s chief medical officer told the NYT. “But I’m admitting that American medicine has overpromised when it comes to screening. The advantages to screening have been exaggerated.”

The LA Times has another slant on the story.

Professor Ian Olver, CEO of Cancer Council Australia, says it is important to consider the pros and cons of screening for each type of cancer, rather than making blanket statements.

He writes:

“It is not helpful to bundle prostate and breast cancer together in a discussion about the benefits of screening. The aim of screening is to diagnose cancer or pre-cancerous conditions early to significantly improve treatment outcomes. It should never be interpreted as guaranteeing cure for all individuals.

The term “over-diagnosis” can apply to people who have cancers detected by screening but who would have died of something else before the cancer would have been detected in the absence of screening. Obviously very slow-growing cancers would make over-diagnosis more likely.

After many years of mammographic screening for breast cancer, the International Agency for Research in Cancer has estimated that the reduction in the death rate from breast cancer in the main target group of 50 to 69 year olds is 35%, a significant mortality benefit, but not without some cost.

The estimate from the initial mammography trials of over-diagnosis is 2 to 3% (that is cancers that would not have progressed if left untreated). Adding in the pre-invasive DCIS (ductal carcinoma in situ) the range of estimates of over-diagnosis is around 9%. However, this still means that the vast majority of detected cancers did need treatment and that lives were saved.

Prostate cancer is quite different. There is no history of population screening programs to study. Two large randomised trials of PSA testing of asymptomatic men from last year had differing results.

No change in the death rate from prostate cancer was found in an American study while in the European study a 20% relative decrease in mortality was reported.

The overtreatment rate in this study was that for every 49 men who underwent prostatectomy only one life was saved, yet each was at risk of the side effects of impotence and incontinence.

Over-diagnosis and over-treatment are why Cancer Council Australia and a number of other health groups recommend PSA screening be an individual choice. Further research should be encouraged in this and other cancers to find better screening tests and tests that will identify indolent cancers which don’t need immediate treatment.

So, although it has always been known that not every individual will benefit from screening, in the proven population screening programs, for cervical cancer, breast cancer and colorectal cancer, the likelihood of reducing deaths from these diseases outweighs the chance of over-diagnosis.

Nonetheless individuals need to be informed of both the risks and benefits.

It would be a pity if doubts about over-diagnosis discouraged participation in these programs by the groups most likely to benefit or dissuaded government from completing the roll-out of the colorectal screening program,  so that it could not reach its full potential of saving 30 Australian lives each week.”

Regular readers may remember that earlier this year Michele Kosky, executive director of the Health Consumers’ Council in WA, asked the TGA and Medicines Australia to investigate whether the consumer advertisement breaches the ban on direct-to-consumer advertising of prescription medicines.

In June, Croakey reported back that Kosky had not had any response from the TGA. Now it is October and, when I checked recently, she still had not had a response. Perhaps someone from the TGA might like to enlighten us about why the long delay?

Meanwhile, in case you missed her story in the Crikey bulletin last week, Dr Agnes Vitry, from the University of South Australia, has been examining some of the broader issues around direct-to-consumer advertising.

“Pfizer is running a big marketing campaign for its combination heart pill, Caduet. Medical magazines have been carrying full-page advertisements, advising doctors that “patients will soon be asking about their suitability for combination heart medications”.

The advertisement includes a sample from a consumer advertising campaign, which advises readers to talk to their doctor about a combination heart pill if they’re taking multiple medicines for their heart. The consumer ad incudes a rip-out section to take to the doctor, which carries a Pfizer logo and says “I’d like to discuss my treatment for high blood pressure or high cholesterol. Please advise me if a combination heart pill is suitable.”

This is occurring despite a Medicines Australia Code of Conduct, which complements the Australian legislation that prohibits direct-to-consumer advertising of prescription medicines. However, the code has several loopholes that allow pharmaceutical companies to subvert the ban on DTCA.

Unfortunately, direct-to-consumer advertising of Caduet is not an isolated case.

De facto direct-to-consumer advertising increasingly occurs in the form of “unbranded” advertisements or campaigns about specific diseases and conditions, which do not mention of the name of a specific medicine, but may include the company name or their logo.

Famous examples of unbranded marketing campaigns include the Viagra “Welcome Back Tiger” campaign. Pfizer, the maker of Viagra, simultaneously advertised to GPs and to consumers in popular magazines. The only difference between advertisements was the “omission” of the product name and product information in the consumer version. The tiger character became prominent in subsequent campaigns, making it synonymous with the product.

There are multiple examples of ongoing de facto DTCA campaigns in Australia. For example, Pfizer is currently running the “Master” marketing campaign for Champix (varenicline), a new drug marketed for smoking cessation.

The consumer campaign includes TV, radio, outdoor and online advertising. The “Master” is featured by a pack of cigarettes, “representing the manipulative inner voice of nicotine addiction”. This campaign encourages smokers to seek healthcare professional advice and visit outsmartcigarettes.com, a commercial website listing websites for smoking cessation products such as nicotine replacement product. At the same time, Pfizer is promoting Champix towards doctors and pharmacists and give them promotional leaflets to distribute to their patients.

Wide-scale advertising to the public of new medicines, whose long-term health effects are still unknown, is a threat to public health as two-thirds of the medicines that are withdrawn from the market due to safety concerns have been on that market for less than three years.

While advertising a medicine for smoking cessation such as Champix may seem a laudable objective, Champix is a new drug and as such, may cause severe adverse effects that may only be discovered post-marketing. No surprise, it is actually what happened with Champix.

Since the initial marketing of Champix, medicine agencies around the world have issued stronger and stronger safety alerts. In the United Kingdom, 1241 reports of suspected adverse reactions were received during the first year of marketing, mainly psychiatric adverse effects with headaches, abnormal dreams and nightmares, depressions and depressed moods and suicidal ideations.

In December 2008, the Australian Adverse Drug Reactions Advisory Committee (ADRAC) bulletin stated that they had received 339 adverse reaction reports with varenicline up to October 2008, more than 72% being psychiatric symptoms including depression, aggression, agitation, abnormal dreams, insomnia, hallucination and anger. There have also been reports of suicidal/self-injurious ideation or behaviour.

In July 2009, the US Food and Drug Administration required Champix to carry the agency’s strongest safety warning over side-effects including depression and suicidal thoughts. Despite the new, stricter warnings, the FDA said consumers and doctors still have to weigh the benefit versus the risks when taking the drug. “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, the director of the FDA’s Centre for Drug Evaluation and Research.

Another ongoing DTCA campaign is the Bayer’s campaign on how “low testosterone can take the life out of you” (for example, full-page advertisement in the  August 22-23 Weekend Australian Magazine). This campaign encourages men to see their doctors if they have any symptoms such as “lack of vitality, reduced sex drive, mood swings, poor concentration and reduced strength”.

Bayer’s low testosterone campaign is typical of a disease awareness campaign that is used as a strategy to extend the boundaries of illness and to expand markets for new products. In the case of Bayer’s campaign, men are told to view non-specific and common symptoms that may occur in ageing as a treatable disease that could be cured. It is similar to the promotion of hormone replacement therapy (HRT) for menopausal women.

And when you have the “disease”, look out for the drug! A single internet search showed that Bayer was marketing in Australia a range of testosterone products, such as Reandron 1000 and Testogel. The use of testosterone products (androgens) in men outside very limited indications is not a harmless measure.

Severe adverse effects from inappropriate use of androgens include sodium and water retention, oedema, acne, gynaecomastia, impotence, testicular atrophy, priapism, inhibition of spermatogenesis, degenerative changes in seminiferous tubules, impaired glucose tolerance, hypercalcemia, polycythaemia, decreased clotting factors, increased LDL cholesterol, aggressive behaviour, psychotic symptoms, physical and psychological dependence, withdrawal symptoms etc.

The ban on DTCA is related to the ban on direct sales of prescription medicines. It a health protection measure to prevent unsafe and unnecessary medication use. The ban on DTCA is consistent with regulatory aims to protect health and with the National Strategy for Quality Use of Medicines to encourage appropriate medicine use. DTCA may pretend to be information, but its primary objective is to increase sales of one particular medicine without any consideration for the public health issues.

Unbranded product advertising and disease-awareness campaigns are two of the most common forms of DTCA that should not be allowed in Australia if the current regulatory ban was properly enforced.

Over the past 20 years, several complaints have been sent to Medicines Australia about unbranded product advertising and disease-awareness campaigns. To our knowledge, they have never been upheld if the name of the advertised product was not explicitly mentioned in the advertising campaign. Any further complaint to the TGA would just remain ignored because of their absolute “trust” in the efficacy of the self-regulatory system for the control of drug promotion.

In the past few years, the successive waves of international scandals have revealed to a wide public that misleading drug promotion and unethical behaviour of top international drug companies were systemic problems and not isolated cases. The passive attitude of regulatory agencies will have to change if they want to keep the trust of the Australian public.

Parliamentary Secretary for Health Mark Butler recently declared that the government has begun to conduct a complete review of how the relationship between pharma companies and doctors is regulated. We hope that the Australian government will take vigorous steps to enforce the ban of DTCA in Australia including unbranded product advertising and disease-awareness campaigns. We hope that we will regain confidence in the Australian regulatory agencies to achieve what they are meant to achieve: preventing unsafe and unnecessary medication use and protecting the Australian public from the harm of misleading drug promotion.”

• Dr Agnes Vitry is a member of Healthy Skepticism and Health Action International

Vern Hughes, the Secretary of the National Federation of Parents Families and Carers, has joined the discussion which has been going on here, here, here, and here at Croakey and also at Inside Story.

He writes:

“The National Federation of Parents, Families and Carers was one of just two organisations out of 319 which supported the model of competing health plans recommended by the National Health and Hospitals Reform Commission (NHHRC) in its landmark Final Report in June.

The other was Medibank Private.

Defying political orthodoxy, the Federation advocated a system of competing health plans, now badged as Medicare Select, as the only option compatible with a consumer empowerment agenda and consumer-centred transformation of the health system. As we said in our submission,

The Commission should to be bold in advocating Option C
as the only practical framework for health reform that is
based on consumer choice, allowing consumers to choose
a health plan of their preference. Options A and B are
bureaucracy-centred, provider-driven frameworks.

We think a system of competing health plans which enrol populations of consumers, hold and aggregate funds on their behalf, appoint and fund personalised care coordinators for consumers, and assemble packages of integrated care, is better than a model of regional health organisations which ‘capture’ consumers by locality without the accountability than comes from consumers having the power to exit one organisation and take our money and purchasing leverage to someone else.

Why did we adopt this position?

The Federation was formed in 2007 by families/carers of people with disabilities, mental illnesses, aged frailty, and chronic illnesses, usually with two or more of these conditions simultaneously. The families share a common experience of terrible fragmentation and discontinuities of care in their various situations, and are people who have been very active in trying to change these situations. Because of this, they understand, more than most families, what an agenda of coordinated care and consumer choice is about. Many of them exercise consumer choice and self-management of support packages in disability, accident compensation, and increasingly in aged care.

As a pool of families/consumers who understand the agenda of coordinated care, our attention has inevitably turned to general health reform, and a desire to be able to ‘cash out’ various health care payments and entitlements into services that support our loved ones in a pre-emptive, preventative fashion and without the usual service and disciplinary fragmentation. Hence the Federation’s interest in the idea of a health plan that aggregates funds from various sources, and assembles these funds in individual packages of care.

Our view is that practical innovation in consumer empowerment is necessary to get the health reform debate out of the stagnant left-right dichotomy that has paralysed it for decades. The left opposes private sector interests in health and advocates public sector managerialism as an antidote. The right opposes public sector managerialism and advocates private sector managerialism, with heavy state subsidies, in return. The big losers here are consumers. Neither side begins with consumers or a commitment to a consumer-centred health system.

The Federation welcomes the current debate about Medicare Select because at long last the consumer has a chance to become the central player in health reform. We are inviting individuals and organisations to participate in the CIMID Health Plan project, which will be developed as a demonstration project over the next two years to educate governments, health organisations and consumers in what a Health Plan actually is and how it might work.

The CIMID Health Plan will be a voluntary opt-in health plan for people with chronic illness, mental illness and disability (CIMID Chronic Illness, Mental Illness, and Disability). Individuals with these conditions, and their families/carers, will enrol with the Plan, and the Plan will negotiate with the Commonwealth (as a number of indigenous health organisations currently do) for risk-rated capitation-based allocation of funds (from MBS, PBS, hospital funding, specialist disability, mental health and aged care funding streams, HACC, et al). With these funds, the Plan will put together packages of integrated care for its enrolled members, with a strong emphasis on coordinated care and preventative strategies.

Our aim to have the CIMID Health Plan enrolling consumers from the beginning of 2010, and commencing discussions with the Commonwealth in the new year.

Interestingly, Australia actually has a history of competing health plans, which predated the twentieth century’s infatuation with public sector managerialism and supply-side service provision.

Friendly societies in the nineteenth century were competing health plans. Australians in towns and suburbs across the country joined a society of their choice, with a local focus through a lodge, which contracted with GPs, hospitals and pharmacists for capitation-based services. GPs contracted to a lodge provided unlimited treatment for a member, on call, irrespective of how well or ill they were.

From 1900 to 1950, the left and right fought a long battle against the friendly societies’ place in the health system. The left wanted a state-run system, and the right wanted a practitioner-driven system. The friendly societies were caught in a pincer movement, and were gradually killed off. Chifley’s National Health scheme sounded the death knell. After that the friendly societies were reduced to their current ignominious status as insurers and finance houses.

Rediscovering this history is an important part in contemporary health reform, because without a knowledge of this past, we cannot imagine that ordinary citizens can actually form own health plans. We have been so ingrained with the ethos of managerialism through the last century that we think self-help and mutual aid cannot create the institutions that might best serve our needs. But what’s even more significant is that self-help in health maintenance and chronic illness management is now recognised as the key to good health care practice – even only we had systemic arrangements that supported and reinforced self-care.

We think the Commonwealth should be explicit in seeking to encourage and enable aggregates of health consumers, based on cultural or philosophical or religious preferences, to form their own health plans within a competitive framework. This would mean, for instance, an indigenous communities-based health plan, a Catholic-based health plan, a New Age complementary medicine-based health plan, a sports health plan, and so on, to provide genuine consumer-based competition with genuinely different ‘products’ to choose from.

Existing private health insurers, who offer identical products at identical prices to a public that is justifiably not interested in their products, would have to reinvent themselves dramatically to compete with genuinely community-based health plans of this kind.

Rediscovering this history, and developing innovation in consumer self-organisation, are essential parts of the process of enabling Australians to own major change in the health system by understanding it as a return of health care to ‘our’ communities, away from control by bureaucrats and providers.

Medicare Select is a framework in health reform that is compatible with these dynamics. At last we have something in health reform that is worth debating.”

• For information on the CIMID Health Plan

Katoomba Hospital staff - new media activists

You could see it as a measure of the anger and frustration that many doctors, nurses and other health professionals feel about the NSW health system and those charged with running it – including the managers, bureaucrats and State Government.

And you could also see it as a fascinating example of the potential offered by new media for breaking down some of the political and bureaucratic barriers that inhibit open public discussion about the health system. This problem is, of course, not only an issue in NSW. All health departments – federal, state and territory – do an excellent job of keeping the clamps on tight – threatening staff who speak out publicly with sanctions.

It may seem a bit over the top for the Katoomba staffers to be comparing themselves to those who confronted the tanks in Tiananmen Square 20 years ago. No doubt this reflects both the sense of fear and solidarity that the staffers are experiencing. No doubt as well that the Ministerial and bureaucratic tanks will be on their way west soon, if they’re not already.

I asked the bloggers if I could interview someone about the campaign. But they declined, saying they had to remain anonymous, and sent this email:

“As you no doubt will appreciate, the key to our survival is anonymity. Basically, the role of our blog “Who Will Speak For Us?” is to leak information out to the community which they can verify themselves. We have a strong community based lobby group here in the Blue Mountains (HEAL- The Health Equity Access Lobby) whose work has saved Maternity Services at the Hospital.

Because of the gagging of staff, we were unable to let them know what was going on in the Mental Health Unit, Rehab Unit, Theatres, and Kiosk. Some of the staff got together and came up with the idea of an anonymous blog in order to leak information so that the Community knows what questions to ask.

For instance, five beds were closed in the Mental Health Unit since May this year, but the Community did not know until August when we posted it on our blog. They were able to verify these facts by asking the Hospital and Area Health Services.

If we break the anonymity, the staff who have come forward will stop coming forward. You have to realise that everyone in the Executive of the Sydney West Area Health Service who has said “trust me” and has betrayed that trust, so we have to operate the way partisans do.”

It will be interesting to watch the impact of this campaign; will it make any difference; will it galvanise community activism; will we see some copycats springing up; will there be new clauses in employment contracts banning the use of online media?

PostScript:  The bloggers are claiming credit for this local headline in the Blue Mountains Gazette.

Dr Sumitra Ananda, a cancer specialist in Melbourne, is hoping the Federal Government acts on the new findings.

She writes:

“The recent report in the MJA by our group supports the fact that the National Bowel Cancer Screening has the potential to save lives and decrease mortality. The first indicator of this is the dramatic shift in stage distribution between those that were diagnosed through the program and through symptomatic presentation.

Bowel cancer is the second most common cancer in Australia and also second in terms of mortality.

We have known from large randomised controlled trials that there is a potential to reduce mortality by 16-33%.

Breast cancer on the other hand, ranks lower in terms of mortality in Australia but has an established widespread screening program targeting women aged 50-69.

The current program has had a limited roll out to those aged 50, 55 and 65 and has only one screening with no re screening offered.

It is crucial that the government fully roles out the program with rescreening which could potentially save lives and ultimately save cost.

Participation is also a key to the success of a program and comprehensive communications campaign to maximise participation are necessary. The main reasons are likely to be the lack of awareness of the benefits of screening and reluctance or embarrassment to collect and send in a stool sample.

The study also suggests the apparent lack of uptake amongst the socially disadvantaged sections of the population. This may be due to lack of understanding, lack of interest  a study showed that people from more economically deprived areas had less interest in pursuing the test) or access (not the case in our study).

Another consideration would be that these individuals are undergoing initial screening but then not pursuing follow up or have difficulty accessing colonoscopy.

Given the potential impact of the screening program and its potential to save lives, the government must consider the complete roll out of the screening program and support the resources needed to sutain it.”