It’s telling that a new report from the NSW Cancer Council called Roadblocks to Radiotherapy is using the power of patients’ stories to raise broader issues of concern about the inequitable access to radiotherapy that have been highlighted in literally dozens of reports and inquiries over the years. It will be interesting to see whether this report has more impact than all those that have gone before.

Radiation oncologist Professor Graeme Morgan has been a tireless advocate over many years for improved access to radiotherapy. Here is his analysis of the report – and a call to action:

“On Friday, NSW Stateline documented the personal traumas of cancer patients attempting to access grossly inadequate radiotherapy services provided by NSW Health.

In NSW, only 36% of cancer patients receive radiotherapy – well short of the benchmark of 52%. In June this year, the NSW Auditor-General criticised the inability of NSW Health to provide enough treatment machines and recommended it develop a 10 year Strategic Plan for Radiotherapy.

Although NSW Health now has a draft Plan, it fails to substantively tackle the lack of access and equity for treatment.

But the rest of Australia is little better with the national radiotherapy treatment rate at 38%, largely unchanged since 1999 – varying from 43% in Victoria to 31% in Western Australia.

How has this been allowed to happen? Well, it’s not due to a lack of reports or inquiries – in the 10 years from 1986 to 1996 over 50 reports had been published – an average of 5 per year.

In 2002, former Senator Peter Baume in “A Vision for Radiotherapy In Australia” recommended the formation of a central body – Radiation Oncology Australia  – for planning, quality and funding, and to overcome the fragmentation between different levels of government – sound familiar?

But after seven years, little has been achieved – still only 38% are being treated, but the number missing out has risen from 7,400 in 1999 to 16,200 in 2008, and as a result 2,500 premature deaths each year due to lack of radiotherapy.

In the last Federal budget, funding was announced for ten regional cancer centres. But this will be to no avail if money is not allocated through a central body for radiotherapy – as occurs with chemotherapy through the PBS.

During the election campaign, Rudd committed to taking over health care from the states if they could not show they were able to improve service delivery within 12 – 18 months. In the case of radiotherapy services, the States have had years to address the problem.

It’s time Rudd took over so that all cancer patients in Australia have equitable access to this essential cancer treatment.”

And now for an anecdote from Croakey:

Last year, when researching an article on cancer care in the bush for Australian Rural Doctor magazine, I heard many distressing stories about what the lack of radiotherapy services in the NT means for cancer patients there, especially for those from remote areas. I tried to imagine what it must be like for Aboriginal people from remote areas having to travel thousands of kilometres to Brisbane or Adelaide when they were unwell.

It became clear that the trauma of a cancer diagnosis, bad enough in the best of circumstances, is  magnified terribly in remote communities. It inevitably means a long, arduous journey into a foreign world far from home and kin. One doctor told me of  an Aboriginal man with a young family, who  had to spend several months living in a hostel in Adelaide while having radiotherapy without the support of a familiar face. It was his first trip outside the NT. He was not the only such patient the doctor had seen develop serious depression.

Others chose to go without treatment. The doctor told me of one such patient who had to be sent back to Darwin, to die without any family around her.

So there are plenty more powerful stories out there, many beyond NSW’s borders.

That is the suggestion of this very interesting piece below from Patrick Bolton, who has long and diverse experience in the industry.  He has worked as a GP and hospital administrator in urban and rural Australia in several states and territories. He has researched and published in health data, information management and health systems evaluation. He is national vice-president of the Australian Hospitals and Healthcare Association, and Conjoint Associate Professor, School of Public Health and Community Medicine, University of NSW.

Bolton writes:

“When he is not solving the world’s climate and economic problems, I understand that the Prime Minister is touring the nation consulting about the future direction of the healthcare system. I’ve knocked around in, and been an observer of, that system for a while, and I offer the following observations in the hope of informing that debate.

There are always more things that can be done in healthcare than money to do them

As a result, some people miss out on some care some of the time, and this will always be so. This isn’t rationing because there is nothing rational about it.  At present the system responds to this truth by pretending it doesn’t exist. A problem must be acknowledged before it can be addressed.

Some of the people who miss out make a noise – for example by complaining to an MP – and then get what they want. This is unfair on those who don’t complain because it means that limited resources are shifted to the loudest.

It is not irrational for the people who complain to complain. They will benefit, assuming the medical care they receive does more good than harm. It is society as a whole that loses. There is no-one arguing on the side of society as loudly as individuals argue in their own self-interest. The hit the individual faces is large, the personal cost to each individual in society small.

Of greater effect on the system is that healthcare workers make choices for individual patients, not for society. Again this is rational. As a healthcare worker I want to provide the best care for each individual that I look after, and as a patient this is the standard I expect of the healthcare workers who care for me. Even were I prepared to favour the interests of society over the individual, I would have to trust that others in the same position will do the same. If they do not, then my altruism is benefiting them and not me.

This factor creates a difficulty because doctors are arguably best placed to assess which patients will benefit most from which interventions, but any management system that asks them to do this puts them in a position of conflict of interest. This is a source of professional dissatisfaction for healthcare workers

The difference between what people want and what the system can provide is one of the sources of dissatisfaction with the system. It contributes to the perception that reform is required.

The only way to make the health system cheaper is to reduce services

Many of the initiatives proposed by the Hospitals and Healthcare Reform Commission are said to improve health outcomes and so make us live longer and healthier lives. This is desirable if it is correct. Unfortunately, we will all still be dead in the long run, and around 80% of healthcare resources are consumed in the last two years of life, whether we die at 70 or 100. None of the proposed changes are about reducing cost as an end in itself. If the proposed changes work we will live longer – so consuming healthcare resources for a longer period, albeit possibly at a slower rate, then cost the same amount when we finally die.

There a no great savings for the healthcare system in this, although there may be increased  productivity as an offset. Health is a superior good, one on which individuals and communities spend more as they become wealthier, and this may justify additional expenditure.

It is not clear what the objective of the health system is

It is difficult to go somewhere unless one knows where one wants to go. Individual needs, expectations, and capacity to assess outcomes of the healthcare system vary. This means that the perceived purpose of the healthcare system varies depending on who you ask.

It would be surprising if the interests of the most vocal group – healthcare providers – coincided with that of the majority who pay for these services. There are no other areas where the interests of vendors and customers coincide, so why expect this in healthcare?

Healthcare doesn’t seem to make much difference to health

This is well known and such a show-stopper that everybody, me included, seems to acknowledge it and move on. I think it reflects several factors. These are:

a)    There is good evidence that the health of first world societies is closely associated with the level of equality in that society, not to the level of healthcare. If this relationship is causal then it can be argued that one should invest in strategies to promote equality in preference to healthcare.

b)    Individuals are not good at assessing the outcomes of the care they receive and the system is not good at measuring outcomes.

Most people recover from illness, but some do not. The outcome is multi-factorial, so it can be difficult to say which part of an individual’s health outcome is a result of the care that they received and which due to other factors. It is particularly difficult for lay people to judge the quality of the care they receive.

Changes in healthcare tend to be incremental, and so outcomes compare current treatments with alternatives which are likely to be only slightly better at best, as opposed to no treatment. It is generally held to be unethical to compare new treatments against no treatment. One might argue that this is irrational in cases where current therapy has not been shown to be superior to no treatment.

The quality of outcomes measurement of the healthcare system is woeful. Given that much of the money for healthcare comes from the public purse this is a significant failing of accountability.

c)    There is a high error rate in healthcare. International studies repeatedly show that errors in healthcare delivery occur in around 10% of cases. In Australia these errors are associated with about half of all in-hospital deaths. If death is the outcome measure then Australian hospitals may be killing as many people as are killed by the conditions for which they were admitted. The harm that the health system causes may offset any benefit that it delivers.

d)    Estimates are that one-third of what is done in healthcare is unnecessary. Two things follow from this. First, if unnecessary care can be identified and stopped, then the efficiency of the healthcare system can be improved by up to 30%. Second, unnecessary care still causes harm, and this offsets the benefit from effective and necessary care for the system as a whole.

Healthcare in Australia is not a very enjoyable place to work

This has important implications for workforce engagement and sustainability.

Poor work hygiene is bound up in the foregoing issues. It is hard to feel satisfied about what one is creating if the value of the product is at best unclear, and possibly negative.

The response of policy makers to these issues has been to tighten the leash and increasingly micromanage healthcare delivery. Healthcare workers are highly skilled employees, expert at making individualised decisions in complex settings. It is unlikely that directive management can lead to better outcomes that professionals can provide themselves, so micromanagement results in alienation of the work force without improving performance.

Suggested pre-requisites to change

There is nothing new in any of this, but it needs to be said because the healthcare system cannot improve until these factors are addressed. Some suggestions to do this are:

1.    The new health system needs to be as clear as possible about what it is trying to achieve, and collect data which measures performance towards these achievements.

2.    The new healthcare system needs to be able to demonstrate that the things that it does are effective, cost effective and done to people who will benefit, and not those who will not.

3.    The new health system is going to have to allocate resources transparently on the basis of 1 and 2 above. This is so that equity and efficiency are maintained in the face of other interests.

Addressing these factors is necessary but may not be sufficient. If they are addressed, then healthcare will improve under the current governance model. Some other governance model may be preferable for the reasons currently being debated, but we can’t know this until the problems discussed here have been addressed.

No governance model can be properly assessed until these underlying distortions are addressed. Introducing the kinds of major change contemplated is not without risk. It will be impossible to manage and measure the impact of this risk until these factors are addressed.”

There I told you – it was worth taking the time for the read, wasn’t it? Plenty of food for thought there.

She writes:

“Last week the 2009 annual report from the National Committee for Quality Assurance  (NCQA) was released.

The NCQA is a private, not-for-profit organization that was founded in 1990. The State of Health Care Quality report monitors and reports annually on performance trends over time, tracks variations in patterns of care, and provides recommendations for future quality improvement.

This report highlights how valuable an independent analysis of quality measures for private health insurance plans and the two government-funded plans, Medicare and Medicaid, is for everyone involved – policy makers, budget managers, health care services and professionals and patients.  The analysis is based on data that the health plans report voluntarily.

This year the results are disappointing, as they show that for the third year in a row, the quality of US health care has not improved across many key measures of clinical quality.

There are probably multiple reasons for the flat results of 2009, but a key factor is the lagging US economy which has led purchasers to focus more on cost than on quality.  Insurance plans have naturally followed suit and paid more attention to negotiating discounts and less to improving performance. And the most effective tool — tying payments to performance — is not being well utilised enough, especially by the Medicare program.

A related issue is that a many Americans lose their jobs, there is greater demand on Medicaid programs at a time when stets budgets are under maximum pressure.

But the report also shows that quality care is not necessarily expensive care, which does mean that in difficult financial times, improvements in quality should still be possible

Failure to jump-start quality improvement carries a significant price. This report estimates that improvements made in years past have saved between 165,000 and 272,000 lives, and there is much more progress possible. If all health plans performed at the same level as the top 10 percent of plans (the 90th percentile), between 49,400 and 115,300 deaths could be prevented each year, along with billions saved in health care spending.

The NCQA goes further with the data which is reported to them  – they rank the plans and publish the results every year in USA Today and on their website.

This transparency is not without its downside, and the private health insurance funds, under pressure from promised health care reforms, have been doing their best to airbrush their failing results.

As the NCQA President states in the preface, “This report provides ample evidence of the need for reform. ……These warning lights cannot be ignored.”

Will we ever get to such openness in Australia?  And would we feel that health care reform was a little more urgent if we had some longitudinal data to highlight where quality could be improved, and lives and dollars saved?”

Lesley Russell is the Menzies Foundation Fellow at the Menzies Centre for Health Policy at the University of Sydney and the Australian National University, and a Research Associate at the US Studies Centre, University of Sydney. She is currently a Visiting Fellow at the Center for American Progress in Washington DC.

But at least we now have some idea of what sort of questions we should be asking, thanks to a report released this week by the Australian Institute of Health and Welfare, called Towards national indicators of safety and quality in health care (and available here).

The Australian Commission on Safety and Quality in Health Care funded the Institute to develop safety and quality indicators for various health settings, including primary care and community health care services, hospitals, specialised health services (such as palliative care, defence health services etc), and residential aged care.

Now that we at least know the questions to ask, we’re somewhat further down the path towards open public reporting of health service performance.

The report notes, however, that the issue remains extremely contentious and that “Australia has yet to follow the lead of countries such as the United States of America and United Kingdom which have adopted detailed regular public reporting at the provider level”.

While there are many concerns about the impact and usefulness of open public reporting, the report says it could have two purposes: to provide transparency and to inform decision-making about overall priorities and system-level strategies for safety and quality improvement; and to inform quality improvement activities of service providers.

It cites one study comparing the degree to which performance information stimulated quality improvement activity in hospitals if it was publicly reported or if hospitals received private reports.

The authors reported finding strong evidence that “….making performance information public stimulates quality improvement in the areas where performance is reported to be low. Since quality improvement efforts among the public-report hospitals appear to be significantly greater than in hospitals given only private reports, there is added value to making performance information public.”

To give you an idea of the indicators suggested by the report, they include:

For primary care and community health services:

• General practices with a register and recall system for patients with chronic disease
• People with moderate to severe asthma who have a written asthma action plan
• Mental health care plans in general practice
• Annual cycle of care for people with diabetes mellitus

For hospitals:

• Assessment for risk of venous thromboembolism in hospitals
• Pain assessment in the emergency department
• Stroke patients treated in a stroke unit
• Complications of transfusion
• Health care associated infections acquired in hospital
• Adverse drug events in hospitals
• Malnutrition in hospitals and residential aged care facilities
• Pressure ulcers in hospitals and residential aged care facilities

For specialised health services:

• Post-discharge community care for mental health patients
• Functional gain achieved in rehabilitation
• Multi-disciplinary care plans in sub-acute care

For residential aged care:

• Oral health in residential aged care
• People receiving a medication review
• Falls resulting in patient harm in hospitals and residential aged care facilities

The report note that indicators already exist for specific types of services, including Key Performance Indicators for Public Sector Mental Health Services, Australian Council on Healthcare Standards clinical indicator sets, for specific population groups such as the Aboriginal and Torres Strait Islander Health Performance Framework, and the COAG National Healthcare Agreement Performance Indicators.

Now that we have all these questions to ask, when will the answers be made available to the public? And will we make best use of them? So many questions searching for answers…

Carol Bennett, executive director of the Consumers Health Forum, is encouraging the public to discuss the pros and cons of vaccination with their health provider, rather than relying on media coverage to inform their decisions.

Here is what she has to say:

“While I do not claim to be an expert on the H1N1 vaccine and the specific risks associated with the vaccination, I think we will need to rely on individual health service providers to be aware of, and inform, consumers about the risks rather than expecting consumers to rely on a broad media discussion of potential risk factors.

I know that the risks of any vaccination vary considerably according to individual characteristics – a preschool child has different risks to a teenager who has different risks to an obese middle aged nurse or an older businessman with pre existing asthma and diabetes.

Knowing there are some risks does not inform individuals about how the risk relates to them personally.

I am not one to support health consumers being treated as mugs, but I am confident most health consumers would prefer to discuss their specific circumstances with their health service provider rather than base their risk assessment on generalised advice provided by media summaries of a Health Minister’s statement about potential side effects.

My reading of the media is that the Health Minister has been transparent in both the advice she has received (including potential risk factors) and the policy that she is adopting.”

Below is a document that the Medical Indemnity Protection Society has sent members, making it clear that they will be covered only if they obtain informed consent from patients. This means discussing the potential benefits and risks of vaccination versus no vaccination.

It is interesting to contrast what the Government is telling the public with what doctors are expected to tell their patients. Quite a contrast.

Now, don’t get me wrong. I am not opposed to vaccination per se, and I am certainly not seeking to inflame anti-vaccination campaigns generally.

What I do want, however, is for those in positions of authority to be upfront and honest with the public – in the way that the health professionals charged with delivering the vaccination program are expected to be.

I’ve been thinking about what Minister Roxon could feasibly say when asked about the pros and cons of vaccination and issues such as the infection control concerns around multidose vials.

Of course she doesn’t want to say anything that will lead to alarmist tabloid headlines. But that doesn’t mean she can’t acknowledge that there are legitimate concerns, and to explain how these are being addressed.

Apart from anything, this discussion might help members of the public play a more active role in their care. I was struck by a comment on the earlier Croakey post, where a reader asked: “Is there anything ‘mug consumers’ of swine flu vaccination can do to minimise their risk of contamination with multidose vials?”

It’s not such a silly question. Ensuring consumers are informed about potential risks is well acknowledged within the broader safety and quality field of being one way to minimise the risk of adverse events or to ensure they are effectively managed if they do arise.

If the Government insists on treating the general public like mugs who are incapable of engaging with these issues in a sensible way, it is missing an opportunity. And so are the health professionals who would prefer all these debates stay firmly behind closed doors.

Anyway, enough ranting from me. Here is the advice from the Medical Indemnity Protection Society to doctors:

SWINE FLU VACCINATION – MEMBER INFORMATION
The Australian Government plans to distribute the swine flu (H1N1) vaccine in the near future. This information from MIPS clarifies the indemnity issues surrounding this vaccination program for members and their employees.

Indemnity for members
MIPS will indemnify its members for administering the H1N1 vaccine however, members are required to:
•    provide patients with adequate informed consent including a succinct summary of the current information needed to make an informed decision about H1N1 vaccination.  This should include information about the risks of the vaccine, the general risks of an injection and risks of electing not to have the vaccine;
•    follow the current draft RACGP Guidelines for the use of multi-dose vials (MDV’s) available at http://www.racgp.org.au/h1n1/33545; and
•    meet MIPS general requirements of appropriate qualifications, training and experience.

Informed consent
Members need to appropriately advise patients of the risks of H1N1 and the risks of having or not having a H1N1 vaccination based on their individual circumstances so that patients can make an informed decision (and therefore provide informed consent to undergo vaccination).
For example this should include:
•    information regarding risks associated with H1N1 compared with seasonal flu;
•    information comparing risks from catching H1N1 compared with risks associated with vaccination;
•    advising that the vaccine is currently undergoing clinical trials; and
•    that it is currently not clear whether one or two doses will be required to achieve immunity.

Although presumed, it is not yet confirmed that the risks of H1N1 are in general much higher than normal seasonal flu and/or the extent that the risks of H1N1 are more serious and/or more likely than the risks associated with vaccination.

According to the Australian Government there have been no concerns raised from early vaccination trial data, however it is possible concerns might be subsequently identified.  Members should also set patient expectations that a second vaccination dose may be required and ensure appropriate recall systems are in place to achieve that.

Ultimately, it is the patient after having been appropriately informed, that must make a decision as to whether they wish to proceed with vaccination or not.

Information material
The Australian Government has advised it will provide health professionals and patients with Pandemic H1N1 Influenza Vaccine Information material and also a “consent” form. These should be used.  Refer www.healthemergency.gov.au.  As for any health service the patient’s medical record must also reflect advice given and the patient decision.

Multi-dose vials
For adults the H1N1 vaccine will be presented in multi-dose vials. Practitioners and patients need to be aware of the steps taken to remove potential risks associated with use of multi-dose vials particularly in relation to vertical transmission of blood borne diseases. Strict adherence to the RACGP Draft “Guidelines for the use of multi-dose vials” is required by MIPS because it will remove that risk and thereby provide confidence to patients when making a decision about H1N1 vaccination.

Other matters
The normal issues associated with seasonal influenza vaccines for e.g. egg allergies/potential issues with preservative, risk of bruising, infection, sterile abscess, nerve damage etc. remain for consideration in respect of H1N1 vaccination.

In addition, strict attention to maintaining the cold chain (especially in view of the huge volume of vaccine and potential vaccinations) provides a greater challenge than for other vaccination programmes.

Indemnity for members, those under members direct supervision and practice staff
For those members whose practices are considering arranging for employed staff such as practice nurses to administer the vaccine, in addition to compliance with the above requirements (e.g. for advice and use of multi-dose vials) it is important to remember under the individual MIPS Insurance medical indemnity policy a MIPS member is covered for vicarious liability claims that arise from the provision of healthcare by others under the member’s direction in accordance with clause 12.1.7 of the member’s medical indemnity policy. The relevance of the clause is the requirement for the member’s appropriate and adequate direct supervision and also for the supervised individual to act within practice protocols. The MIPS Insurance Policy can respond if the member’s practice staff seeks indemnity from the member on the basis that the claim against them is as a result of the member’s actions or inactions but only if all requirements are met.

MIPS Members’ Practice staff and the practice entity are also indemnified in accordance with the terms and conditions of the MIPS Member Practice Entity Policy. (A practice entity is defined as a practice in which a member has a financial interest and the majority of shares are owned by medical practitioners working in the practice). In general terms this policy provides cover for health care errors made by practice nurses, receptionists and other administrative staff who act independently and which may financially implicate the practice and/or the member.

It is important to remember that MIPS requirements (as listed above including consent and use of RACGP guidance for the use of multi-dose vials) will be a pre-requisite in relation to indemnity for any H1N1 vaccination matters that arise.

Asked about infection control concerns surrounding the use of multidose vials(as outlined in this Crikey story recently), Minister Roxon said these are “very minimal”.

Does she realise what dangerous territory she’s entering here?

Our national infection control guidelines (you can read them here) state that the use of multidose vials is a “high risk” procedure (p49).

The guidelines cite the Australian Drug Evaluation Committee’s advice that “injectable products packaged in multidose vials should not be used except where products such as insulin are intended solely for the exclusive use of an individual patient”.

The guidelines also state: “When single-dose vials or ampoules are not available, the risk of cross-contamination is high if injectable products are used on multiple patients.” They recommend several measures for controlling this risk.

If the Government and its advisors have decided the potential benefits of a mass vaccination program outweigh the costs, including potential harms, then fair enough. Not everyone agrees with them, but that’s their call.

It’s another matter entirely to mislead the public in an effort to sell their program.

This will come back to bite them on the bum, pardon the language, if history is any guide. You don’t have to look too far back to find an example of the perils of health ministers spruiking pharmaceuticals.

Below follows is an extract from Ten Questions You Must Ask Your Doctor, which I wrote with another health journalist Ray Moynihan. This particular section comes from a chapter urging readers to be more alert to the possibility of side effects from medications and notes that these are often downplayed.

“In June 2000, the then Australian Minister for Health, Dr Michael Wooldridge, issued a most extraordinary media statement. In it, he announced that the first of a new class of arthritis drugs called COX 2 inhibitors would be funded by the Australian Government. He said the drug, celecoxib (sold under the brand name Celebrex), was significantly safer than older types of drugs used to treat arthritis and called it a ‘major breakthrough in arthritis therapy’.

It was highly unusual that a Health Minister would feel the need to single out any one drug for such an enthusiastic plug. It was even more remarkable considering that a careful reading of the scientific literature would have shown there were already rumblings of concern about the safety of COX 2 inhibitors. Over the next few years, these rumblings turned into a roar of alarm and an international scandal damaging public trust in drug regulatory agencies, medical journals and drug companies alike.

We now know that tens of thousands of people around the world paid a very high price – suffering heart attacks and strokes – for following advice to take drugs that they had been assured, wrongly as it turned out, were safer than older types of arthritis drugs.

Taxpayers and patients also paid a very high price for the overly enthusiastic promotion of these drugs, which reaped huge profits for their manufacturers. While safety concerns surround many of the COX 2 inhibitors, including the one so warmly endorsed by Dr Wooldridge, the most alarming case is that of rofecoxib, which was sold under the brand name Vioxx by the drug giant Merck.

The history of rofecoxib reveals how so many different groups failed to protect the public’s safety…”

I am not suggesting that swine flu vaccination will turn into this scale of disaster. I sincerely hope not.

But the point is that there are enough lessons from recent history for Health Ministers to be extremely cautious about how they pitch pharmaceuticals and other health interventions to the public.

We need to be able to have an open and frank discussion about the costs and potential harms of any interventions – including vaccines – as well as their potential benefits.

Healthy Skepticism is hosting the panel discussion, at the Women and Children’s Hospital, to examine questions such as:

• Do partnerships with industry (as set out in Australia’s National Medicines Policy) bring about better health  outcomes?

• What are the strengths and deficiencies of our current system of regulation?

• Do the Therapeutic Goods Administration and state regulatory authorities have the political support and resources necessary to maintain objectivity?

• Is public access to regulatory processes and decisions sufficient to properly evaluate the operation of the policy?

The panellists will be:

• Hon Mark Butler MP, Parliamentary Secretary for Health
• Emeritus Prof Lloyd Sansom, AO, Chair, Pharmaceutical Benefits Advisory Committee
• Assoc/Prof Chris Doecke, Director of Pharmacy Services, Royal Adelaide Hospital
• Emeritus Prof Peter McDonald, AM, retired Infectious Diseases physician
• Dr Agnes Vitry, Senior Research Fellow, School of Pharmacy and Medical Sciences, Uni SA
• Dr Ken Harvey, Senior Research Fellow, School of Public Health, La Trobe University
• Dr Jon Jureidini, Head, Department of Psychological Medicine, Women’s & Children’s Hospital, and Chair, Healthy Skepticism
• Dr Peter Mansfield, OAM, GP and Director, Healthy Skepticism

The session will be facilitated by Prof Anne Tonkin Director, Medicine Learning & Teaching Unit, Adelaide University.

And here is the statement announcing the forum:

Healthy Skepticism, the international campaign against misleading health marketing, today called for a major review of government controls of medicines in Australia.

“Vioxx killed more Australians than the Victorian bushfires. Just as we re-think bushfire preparedness, it’s time we re-examined how well the public is protected by pharmaceutical regulation,” said Dr Peter Mansfield, the organisation’s director.

Australian regulatory processes failed to prevent the Vioxx disaster a few years ago because of failure on several fronts: “Drug regulators did not warn prescribers appropriately about potential cardiovascular risks. The Pharmaceutical Benefits Scheme did not limit unjustified drug expenditures. … Drug companies ran intense and misleading promotional campaigns. … Independent drug information was insufficient to counter the effects of the millions of dollars spent on advertising.”1

Dr Agnes Vitry (School of Pharmacy and Medical Sciences, University of South Australia) says that although Australia has a strong National Medicines Policy compared to most other countries, there are concerns that Australian regulators’ dependence on fees paid by drug companies might create a situation where they are more focused on serving the industry rather than prioritising the interests of public health e.g. by fast-tracking assessments without appropriate data to assess safety issues. The medicines agency requires more power and resources to ensure that safety is actively monitored after drugs are approved.

There are also concerns about Australia’s reliance on industry “self-regulation” to control the advertising and promotion of medicines. As Dr Ken Harvey (School of Public Health, La Trobe University) says, “The focus on self-regulation has produced a plethora of industry codes and complaint systems which makes it difficult for complainants to know where to send a complaint. There are gross inconsistencies between various codes.”

Healthy Skepticism would like to see much more streamlined and effective system, capable of meaningful constraint of companies like Pfizer, whose inappropriate marketing recently prompted US courts to order payment of $2.3 billion.

By contrast, as Harvey says, “Pfizer Australia has had 17 complaints against Medicines Australia (MA) Code of Conduct upheld during 2005-09. Although one of these complaints received the maximum fine of $200,000, over this time the fines only averaged $50,000. There is no evidence that such modest fines have reduced Code violations by Pfizer or other member companies. “

1. Vitry A, Lexchin J, Mansfield PR. Is Australia’s national medicines policy failing? The case of COX-2 inhibitors.  Int J Health Serv. 2007;37:735-44.

More details are available here.

Dawson contributed to the fatigue risk management guidelines which recently caused Queensland Health some media grief, and today he’s taken us well beyond those headlines.  Adelaide surgeon Guy Maddern also wrote about related issues in Crikey this week.

I particularly liked Dawson’s observation that:

“Fatigue risk management is the perfect example of what Tony Blair described as a ‘wicked problem’. That is, one for which the solution is complex, multi-factorial and will require thoughtfulness, flexibility and time. Successful fatigue risk management in health care will require exactly that.”

Using that definition, it seems to me that most problems in health are absolutely wicked.

Instead, he seems to have added fuel to the fire – at least, according to Dr Ken Harvey, who argues that the Government and TGA are making things all too cosy for the industry, at the expense of the public interest.

Harvey writes:

“Australian Medicines Policy is meant to be based on partnership with all the players, including consumers and health professionals. It is not meant to be a bilateral relationship between the Therapeutic Goods Administration and industry.

Yet, once again (see Mark Butler’s press release):

“The TGA is meeting with all the therapeutic industry associations next week to discuss their respective codes and consider potential strategies for a way forward.”

and Mr Butler said:

“I look forward to receiving advice on industry agreed options for working together to strengthen codes of conduct, provide a level playing field, and ensure that self-regulation retains public and Government confidence.”

In my opinion, these bilateral consultations between the TGA and industry are not in accord with the spirit of Australian Medicines Policy and the debate on ethical promotion must be opened up to include health professional and consumer groups as well.

Self-regulation is ultimately self-serving and these matters should not be left solely to the pharmaceutical industry.

If you agree, I suggest you communicate your concern to Mark Butler (as I have done).”

• Dr Ken Harvey is Adjunct Senior Research Fellow, School of Public Health, La Trobe University