Irish Autism Action pointed me to a piece picked up by Yahoo news from October 25th, written by staff from the Coalition for Mercury-Free Drugs (CoMeD) . It is a critique of sorts, of a paper published in Pediatrics, in 2003, on “Thimerosal and the Occurrence of Autism: Negative Ecological Evidence from Danish Population-Based Data” which may be read (free, thanks to the AAP) here.

The paper first.

It is written by seven Danish scientists. Poul Thorsen, of whom more later, is the fourth author. To understand the importance of this paper, you need to know that Denmark has one of the best health information systems in the world. The vast majority of contacts between Danish residents and their health services are recorded, with a unique identifier, which allows one to identify the first contact, and to avoid counting the same people twice. This system is reliable, not infallible, but far better than equivalent systems in the UK. There are no such systems in Ireland.

Thiomersal or Thimerosal

Thimerosal or Thiomersal is a chemical, containing mercury. In the body it is converted to ethylmercury. A lot is known about the toxicity of a related compound, methylmercury, which caused the terrible tragedy of Minanmata disease. Much less is known about the toxicity of ethylmercury, but it is felt to be wise to assume that it too is toxic. Thiomersal has been used as a preservative in multi-dose vaccine vials for many years, but, because of concerns about possible toxicity, is now largely phased out in the EU, and the USA. There has been an extensive controversy about the links between thiomersal exposure in infancy and childhood, and the development of childhood autism.

What the Danish paper adds

The Danes analyzed first diagnoses of autism, (the ‘incidence’ of autism in the jargon of my profession), in children, aged between 2 and 10, and diagnosed between 1971 and 2000. Thiomersal was used as a vaccine preservative up to March 1992. They found just under 1000 cases of autism diagnosed in Denmark over this period. The rate of occurrence of autism is shown in Figure 1 from their paper.

Briefly this shows autism rates low, and steady from 1971 to about 1987 or 1988. After this autism rates rise steadily, first in the youngest children (ages 2 to 4), then in the next group (ages 5 to 6), and finally in the oldest children, (ages 7 to 9). These are children newly diagnosed with autism. Rates are beginning to dip in the two older groups in 2000, as compared with 1999. The vertical line on the graph, in 1992, shows when thimerosal containing vaccines stopped being produced in Denmark.

What does this mean?

This graph shows a significant increase in the incidence of autism. This is similar to that recorded in many other countries at the same time. No-one really knows the cause of this increase. It is widely believed by experts that a big part of it is due to a mix of better access to child psychiatric services, better and more rigorous diagnosis, and to the broadening of autism diagnoses into the Autism Spectrum disorders (see the recent review by Fombonne). This does not mean that some part of the increase may not be real, but it is widely believed that most of it reflects other things besides a real increase in autism.

There are also specific factors which very likely contributed to the rise in Denmark – and are mentioned in their paper. First they moved classification systems, for autism, and all other diagnoses, in 1994, from ICD-8 to ICD-9. Secondly, outpatient diagnoses were accepted from 1995, but the authors examined inpatient diagnoses separately, and found the same pattern in these data. They did not show the inpatient only data, but this is a common practice, enforced by editors, when there is pressure on space in published papers.

It’s easier to say what this does not mean. If you believe that thiomersal in vaccines caused any significant proportion of cases of autism, you should no longer believe this. I can think of no mechanism by which removing a major cause of autism, could lead to a rise in the incidence of the syndrome. The dip in incidence in 2000 is interesting, though modest, but cannot be related to the removal of mercury from vaccines eight years earlier.

And the scandal?

The COMED story makes two specific allegations

• The authors suppressed data from 2001, which showed a further fall in autism prevalence. CDC officials knew about this.
• One of the authors, Poul Thorsen, has been sacked by his employers, Aarhus university, and is under investigation for large scale financial fraud against the US government, related to grants for autism research.

So, let’s take these in order.

Suppressing data?

First, the fall in autism incidence in 2001. As I mentioned the paper shows data up to 2000, with some indication that incidence is falling in 2000 compared with 1999. The email mentioning the 2001 data is largely redacted, so it’s hard to make much sense out of it. But if we suppose that the rate had indeed fallen further, what implication does this have for the published paper? The paper shows clearly a large increase in autism incidence starting a few years before thimerosal was removed in 1992, and continuing at the same pace for at least six further years (up to 1999). Removing thimerosal in 1992 cannot affect autism rates in children aged 5 to 6 in 2000, it is simply impossible. Neither can it affect rates in 2001.

Many scientists in my discipline struggle with the ‘just one more year’ problem. Data are seldom complete on December 31st. It takes time to clean data, to check it, and to make it available. It then takes more time to get it, analyze it, and write a paper about it. By then the next year’s data may have come out. Most of us decide, usually after a quick look at the new data, if we want to hold up the paper for another six months while we repeat the process. At some point, you just have to publish. This is life, not a scandal!

Poul Thorsen

First, a declaration. I know Dr. Thorsen. I have met him two or three times, when I was working on a study to design methods to estimate the prevalence of autism across Europe. If, as alleged, he has defrauded scientific funds paid by the US, to Aarhus university for autism research, I do not defend him. However, even if every charge in the grand jury indictment were proved, I do not see that this ought to affect how we read the paper.

Thorsen was one of seven authors, and was neither the first, nor the last, the two most significant slots in our business. The paper was not funded by his research funds, and had no organic connection with them. No allegation of scientific fraud has been made against him. An ancient, and disreputable debating strategy is the ‘ad hominem’ attack – I can’t attack what you say, so instead I will attack you. Scientists didn’t attack Andrew Wakefield personally, they attacked his paper, because the conclusions he presented, did not follow from the evidence he presented. Similarly, an attack on Poul Thorsen, justified, or otherwise, does not speak to the correctness, or otherwise, of this paper.

One swallow does not a summer make

One of the mottoes of my profession is ‘Never believe one study’. Any single study can come up with a completely wrong answer, no matter how well it is done, no matter how skilled, conscientious, and honest, those who work on it. In the case of thiomersal and autism, there is a small flock of good studies, all saying pretty much the same thing – there is no evidence for a causal link between autism and thiomersal exposure. The paper by Madsen et al. is only one of the flock, but it is flying in the same direction as the others.

Is thiomersal safe?

Many countries still need to use thiomersal, because it is cheap, effective, and allows vaccines to be used safely in hot climates. We don’t use it, because we can afford not to. José G. Dórea, from the Universidade de Brasilia in Brazil, has a very thoughtful review article assessing the evidence, and concludes that, if we have to use it, and Brazil does, we need to be very careful with thiomersal in babies. He finds no good evidence of harm, but this not the same as evidence of safety. If thiomersal has to be used, there are steps that can be taken to protect and develop babies’ brains in other ways, and these ought to be adopted widely in any event. I would fully agree with him.

Scandal?

I do not speak for the Coalition for Mercury-Free Drugs, and I make no assertion about their objectives in writing this story. However, they are wrong. There is no scandal here, and the problems they identify with the paper are acknowledged and addressed by the authors. There is a
long report, sent by CoMED, to Béatrice Sloth of the Secretariat for the Danish Committees on Scientific Dishonesty, which forms, I think, the basis for the press release. I have read it carefully, and I see no evidence of scientific wrong-doing in the report. There are critcisms of the paper, but the major scientific issues raised, the change in diagnosis codes, and the inclusion of outpatient care, are addressed in the paper by the authors. This is not stated in the report.

All in all, this is a non-story. It is typical of too many others, written by people who seem to only half understand the science, and seemingly intended to strike fear into the hearts of parents. Some children died, and many more were unnecessarily brain damaged, by the original measles vaccine scare. Is that not enough? Isn’t it time to stop?

This opinion piece was published in the Irish Times on Tuesday 12th February 2011.

Implementing Social Health Insurance in Ireland, a report of the workshop held on December 6th, 2010, will be published today by DCU. The report is edited by Prof Anthony Staines of the school of nursing in DCU which sponsored the workshop. Participants included Prof Peter Groenewegen of Nivel, the Netherlands Institute for Health Services Research; Prof Orla Hardiman of Beaumont Hospital; Dr Martin White of Nobber General Practice; Dr Steven Thomas of Trinity College Dublin; Dr Gerard Crotty from Tullamore; as well as Dr Davida De La Harpe, FPHM; Dr Michael Drumm, MMUH; Dr Maire O’Connor, FPHM; Dr Susan Smith, Inchicore Medical Centre; Dr Mary Rose Sweeney, DCU; and others

It seems likely the next government will be made up of Fine Gael and Labour. Both propose extensive changes to the health service and both propose to introduce universal health insurance.

Last weekend, Fine Gael published a detailed policy proposing to introduce a social health insurance scheme, modelled roughly on the system in the Netherlands. Labour has yet to publish its detailed policies.

In the Netherlands everyone is required to have health insurance, with the premium paid, or subsidised, by the state for people on low incomes. This provides free access on equal terms to primary care, ie GPs and related services, to prescriptions, to mental health services and to hospital care.

Like our own health insurers, they apply community rating, but unlike ours, they have a working system of risk equalisation. Long-term care is funded separately from other health services.

Can we really implement a social health insurance system in Ireland? A group of national and international experts, clinicians, managers, policy makers and others met in Dublin just before Christmas to consider this question. Some basic principles of care delivery were brought out at the conference.

Care needs to be patient centred, not determined by the needs of the institutions. Access to care must not depend on patients’ resources. A system which places a high priority on equity and social solidarity can be built and can be delivered within the existing budget. Such a system must have accountability, visibility of outcomes, resources and activity.

The first source of concern is the miserable track record of both the Health Service Executive (HSE) and the Department of Health in effecting change. Although there are some recent successes, most notably the partial reorganisation of cancer services, there are a lot more failures. Overcoming this will need political, managerial and clinical leadership, as well as substantial training and support for staff.

The leadership exists within HSE. Will it come out? Will managers and clinicians line up behind the sort of radical reform that is needed? The view of those of us who met before Christmas is that clinical leadership is essential, and will be forthcoming.

In primary care, including general practice, the main obstacle is overcoming decades of underinvestment without spending much money. It is possible to build up primary care relatively cheaply. There are large resources spent in the sector, but there is an absence of co-ordination between different professionals.

Providing shared spaces, meetings and common record systems will cost little, and should be helpful. Moving away from the present highly centralised model of primary care development, acknowledging that the best ideas for primary care development in each area will come from the people working there and supporting a more organic model of service development, more attuned to local needs, will help. This is all quite possible.

The acute hospital sector is of very variable quality and it is impossible to make any reasoned assessment of the performance of these organisations. Maurice Hayes’s recent report on Tallaght hospital, allegedly one of the better run facilities, does not make for comforting reading.

It ought to be possible to save money and get a more intelligent use of resources by merging hospitals into groups with a common management. The first steps on this path have already been taken. A much wider use of shared services is also essential, with, for example, a common purchasing agency for the whole sector.

It will be much harder to get the hospitals to refocus on servicing primary care. To take one example, there are several huge clinics for treating diabetes in Irish hospitals. These are very costly and most of these patients ought to be fully managed in general practice. There are a number of other examples of this kind of pointless gigantism. A revised hospital system would have many staff, doctors, nurses and others, who spent most of their time off the premises.

Long-term care is also a challenge. The question is: “Whose interests will prevail: those of the clients, or those of the institutions which seek to provide care for them?” At the moment the institutions are winning. It’s not at all clear that the Fair Deal nursing home funding policy is economically sustainable.

The nursing home sector grew rapidly, and in a completely unplanned way, thanks to careless tax breaks. It’s not clear that it meets the needs, or the reasonable desires, of elderly people to remain living in their own homes. The budget for home care for the frail elderly is under threat and this may lead to people being bumped into nursing homes who do not need to be there and do not wish to be there.

The same issue affects people with disabilities. A more reasonable model for both groups is to provide them with individual budgets and let them source the care they need, using their own judgement.

The final pieces of the jigsaw are the insurance companies and their regulators. It’s very doubtful if any of the current crop of health insurers have the skills and the capacity to take on the task of running a social health insurance system. The demands on the insurers are much tougher than in our current system, and so the new insurer will cost a lot more to run. In fact, it’s questionable whether there is room for more than one such insurance company in a small country of only 4.5 million people.

Equally, the regulator will need to change its role. Without very tight regulation, and very tough enforcement, a social health insurance system will fail.

A key question is who controls the basic package of services? This is the core compulsory insurance and will be the only cover held by most people. As such it is essential that it provides enough cover; that the quality of the care provided is closely monitored; and that the outcomes of care and other quality measures are made public.

To support all this, Ireland will need a modern health information infrastructure. There are several successful models of this, for example the free open-source Vista system used by the American Veterans’ Administration. Such a system could be in place in three to four years. It would both improve productivity in the system and provide the infrastructure for the health regulator to do its job.

All of this depends on leadership. Without political leadership, nothing at all will happen. Without leadership from clinicians (doctors, nurses and others), what happens will not work. Without leadership from managers in HSE and the Civil Service, what happens will not be sustainable.

Our view is that, if the necessary training and support are provided, Ireland could have a working social health insurance scheme in five years’ time. What are we waiting for?

More detail of our report, and a number of useful resources are found elsewhere on this website.

“Congregated settings” is the jargon term used in our health services to describe facilities where more than ten disabled people live. They range in size from ten up to several hundred, and, apparently, from excellent to very poor. In 2007 HSE set up a “Working Group on Congregated Settings” to ‘develop a national plan and change programme for transferring people with disabilities living in institutions into the community’ (Dail records – John Maloney 6th July 2010 in answer to Phil Hogan).
On July 12th 2010, under the headline “Institutions for disabled should be closed down, says report”, Carl O’Brien of the Irish Times, wrote :-
“ALL INSTITUTIONS for people with intellectual disabilities should be closed down within the next seven years because they are in breach of residents’ basic rights.
That is the main conclusion of an unpublished report by the working group established by the Health Service Executive (HSE) to examine conditions in “congregated settings”, or institutions with 10 residents or more.
The 72 institutions, which cost the State just under €500 million each year, accommodate some 4,000 people. Most are run by voluntary organisations and religious groups. The report recommends replacing them with supported or independent placements in the community.
The report, which is expected to be published in the coming months, found major variations in the cost of care across the congregated settings it surveyed. The average cost per resident was €115,000 a year, while costs ranged between €46,000 and €385,500 per resident in different units.”
The large charities providing services, and HSE, seem to have adopted a pre-emptive strategy. They will build lots of housing for people with disabilities, and fill it with their own long-term residents. This secures the long-term viability of the services, and will, I am sure, improve the conditions for the residents. However, is it what the residents want? Has anyone asked them?
Noelin Fox (a PhD student in Galway, writes “Are we creating new institutions for people with disabilities?” Based on an analysis of our obligations under the UN Convention on the Rights of Persons with Disabilities, Fox argues that parking large numbers of disabled people in campus settings is simply inadequate. It is hard to disagree.
This policy response is proceeding, largely using taxpayers funds, but there does not seem to have been any published economic, or human rights, evaluation of the new developments. It’s not known whether the report, apparently entitled “Time to Move on from Congregated Settings: A Strategy for Inclusion” has done such an evaluation, but they have considered campus settings, as well as dormitory settings in their work.
What is driving the large service providers? It’s possible that they are running scared of the idea of individual budgeting. This strategy would do away with the current focus on large line budgets for single institutions, replacing these with an individual budget held by the disabled individual, or their guardian where necessary. These individual budgets would be used to provide whatever services the disabled person chooses to help them live their own lives. Budgets would be set annually on the basis of an individual needs assessment for the client, rather than the current very cumbersome, and costly, clinical assessments. The implications of this for the existing large scale disability services are profound. They would need to reconfigure very extensively just to survive. However, a large number of new jobs would be created, so the state might get much better value for the same money.
The report remains closely held three weeks before the election. One wonders why?

I’ve just finished watching the PrimeTime program on home care for the elderly. In summary, a number of not-for-profit and for-profit home care providers are using untrained staff, breaching various acknowledged standards, managing care staff very poorly, and generally providing crummy care to some of the most vulnerable people in society.

A nice man, Noel Mulvihill, assistant national director for older care indicates that he will write to his staff to instruct them to monitor the quality of the care they are paying many tens of millions a year for. One wonders what, exactly, Mr Mulvihill and his colleagues have been doing for the last few years. In fairness to them, they have been working hard on standards for residential home care, but I do feel that HSE ought to have considered home care quality too. If you wonder why they have concentrated on nursing home care, try looking up Lea’s Cross on Google.

Even more worrying, Deputy Aine Brady, Minister for Older People, was interviewed. She did not seem very perturbed, at the findings of the report, and expressed doubt about the need for more regulation in the sector. She is one of our hereditary TDs, the daughter of one TD, sister of two others, and married to a fourth.

Kate Hartigan, another assistant national director in HSE, was interviewed after the program on Pat Kenny’s show. She is talking about future regulation, building on their work on defining care packages. They have taken some steps to deal with the companies covered by the program, but it would seem little more has been done. Sara Burke did a nice hatchet job on the staggeringly incoherent policy which has lead us to this mess. The goal of the policy was to drive down the costs, and this has worked. The quality has not been assessed yet. There is still a large amount of variation between counties in service provision.

Can we change this? It will cost money to do it.

The US NAP have just published a report on the ‘Future of Nursing’. I’ve only skimmed it, but I’m impressed enough that I’ve ordered a copy. The US are facing exactly the same types of problem that we face, albeit in an even more dysfunctional system.
The authors note the accumulating evidence that nurses have a vital role in delivering care which is of high quality, accessible, and provides value for money.

They have 4 key messages :-

1. Nurses should practice to the full extent of their education and training.
2. Nurses should achieve higher levels of education and training through an improved education system that promotes seamless academic progression.
3. Nurses should be full partners, with physicians and other health professionals, in redesigning health care in the United States.
4. Effective workforce planning and policy making require better data collection and an improved information infrastructure.

We need to pay attention. The whole report is available from the link above, (registration is required), and ought to be compulsory reading for us all.

There’s a new paper published at Health Affairs which gives the final lie to the general thrust of Irish Government health policy. The heart of the actual policy is the maximization of private health care. The huge expansion of private health care, largely funded by tax breaks, has succeeded. We now have a big private sector, which, according to the CEO of the VHI, “has excess capacity [which] it will take a few years to be utilised. We do not need any more new hospitals. I don’t think we can fund it. I can’t see the business rationale for me as procurer of services to add to that capacity. It doesn’t make sense for us and we are entitled as a procurer who we contract with. Our view is that there needs to be a two- to three-year moratorium on expansion or new facilities.” (Sunday Tribune September 5th).

One might fairly object that this is not stated policy. Stated policy is [still!] the 2001 ‘Quality and Fairness, a health system for you’. However, this is not being implemented, or at least, not so as you would notice, so I prefer to stick with what actually gets done.

So, what are the likely consequences of these policies? Well, the problems of private health care are quite well understood. There’s fair evidence, from other countries, of failures in cost-control, shifting of risks, and costs, to the public sector, and fragmentation of care. The basic inequities in our system are well established. These policies will likely make the problems worse.

There;s new data from the US, published on the 7th. which is very relevant to this discussion. Muenig and Glied examine US 15 year survival data for middle-aged and older people, to answer the question “Is the US health system at least partly to blame for this deterioration in international rankings for life expectancy and medical costs? Or can the declines be better explained by statistical, demographic, behavioral, and social factors?” The short answer, is yes, for the longer answer read the paper.

Brian Kenny kindly invited me to give a talk to the IHCA AGM in Adare, Co. Limerick. I spoke about running the health services through a recession. I also wrote a piece which appeared in the Irish Times, on the same day, Saturday 2nd October. My original slides are here as a 6MB OpenOffice Impress file, and, if you insist, here, as a 6 MB Powerpoint file and here as an 9 MB Adobe pdf.

HSE needs a programme of rapid, focused cost savings

“IRELAND IS experiencing its worst economic crisis since the Great Depression of the 1930s. What are the implications for the public health service of the recent budget cuts and the likely ones to come?

The HSE has had rising budgets since 1995. This rise has partly gone to higher salaries, and partly to playing catch-up from the severe under-investment before then. The HSE will lose about €600 million this year, and is likely to lose as much again, or more, in 2011 and again in 2012.

These cuts are hitting frontline services quite disproportionately, for several reasons. First, many services are delivered by temporary staff, or low-paid staff on short-term contracts. Examples include home helps, some hospital nurses, some social workers, and others. Second, many frontline staff grades are young, and so have higher staff turnover for social reasons. Again, this affects key staff like nurses, community welfare officers, psychologists and social workers. Finally, some frontline services have been, effectively, discontinued, non-emergency dental services being an example. Given another two years of this, our health services will be badly damaged. What can we do to avoid this?

The various problems of the HSE have been thoroughly discussed in the media. It is well known that we have unaccountable services of variable quality. We have a two-tier health service with a vicious bias against poorer people. Our GP services are laughably underdeveloped. We have a large, unplanned, and unsustainable private health sector, which is destabilising the public services and the insurers. Services for adult and child mental health are a national scandal. Services for disability and long-term care are equally poorly developed. Ours is neither a quality nor a fair health service.

There are glimmers of hope. The concentration of cancer services in eight centres has worked well. Drug costs are falling, a little. New clinical pathways are being developed in the acute hospital sector. The quality of HSE management has improved.

There are less cheery signs. The primary care strategy is, more or less, dead. The HSE still has 11 financial systems, which are not mutually compatible. There is still intense confusion of roles and lines of responsibility within the HSE. The co-location of private hospitals consumes scarce HSE management resources.

So, what can be done now to avoid serious harm to patients over the next two or three years? In my view, the HSE needs a better financial structure and a rapid programme of focused cost savings.

The HSE’s financial system was described by the Minister for Health’s expert group on resource allocation as “fail[ing] to meet most of the guiding principles that [we] would consider essential to have a system that is fit for purpose”. There are now two detailed reports on this, one from my colleagues and me and one from the resource allocation group chaired by Frances Ruane. These reports agree in detail and complement each other. We need action on these, not further prevarication.

There are some obvious areas where a lot of money can be saved quickly – drugs, acute hospitals and private healthcare. For drugs significant savings have already been made and more are possible. Examples include the use of restricted drug lists; requiring high levels of generic prescribing; payment for the care of long-term illnesses (eg diabetes) based on following standard protocols of care; setting restrictive budgets for very costly new drugs; and requiring proof of cost-effectiveness for these drugs before they will be reimbursed. All of this could save as much as one-fifth of the total public drugs bill, about €240 million.

Improving acute hospital efficiency is certainly possible. A study of the economies, and the diseconomies, of scale in our system, should guide future decisions on hospital size and location. Measuring the efficiency of hospitals against their peers would be a powerful motivation for change. Requiring hospitals, as well as other service providers, to make more use of shared purchasing and shared services could save a lot of money. Setting up a unified management and budget structure within each of the eight new hospital networks would be a major step forward. I do not know how much this might save.

A decision to stop subsidising private healthcare would save a lot of money. Private healthcare in Ireland receives very large annual subsidies. These include €260 million in tax relief on insurance premiums; €90 million for the National Treatment Purchase Fund; €50 million to €100 million in the subsidy for private patients in public hospitals; and millions more in payments from insurers that never get collected. The tax relief on new buildings costs tens of millions a year at least; the costs of the co-location project are unknown, but might be as much as another €30 million a year. At least €20 million is the cost of training for staff from public institutions. Personal indemnity insurance for private practice by consultants and the two private maternity hospitals is an unknown cost but might be another €20 million annually. The opportunity cost of having consultants working off site is not known, but is probably high. This all costs at least €500 million a year and perhaps as much as €700 million.

A final source of income for the HSE is consultants’ fees. Private health insurance premium income is probably €1.4 billion this year. At least €350 million is paid to people who also hold public contracts. This could be levied directly by their employers, say at a rate of 50 per cent per year, bringing in a very useful €175 million a year.

These are drastic actions, but we live in very hard times. These measures would not be enough to avoid all the problems, but they would be a start. If the State does not do something radical, all health service users will suffer. These are, largely, the elderly, the disabled, the poor and the sick. While services will (still) be inadequate, at least they will be evenly inadequate. Is there any other hope?

Yes there is. It lies in the people who work in our truly awful healthcare system; the people who make it work, day in, day out, despite the problems; the people who do their best for their patients morning, noon and night. The film-maker Alan Gilsenan, writing in this paper on Tuesday, said of a nursing home in central Dublin, “Real care does not reside in the building or its facilities, but rather in the spirit of the people within.” The same is true of the HSE.”