Speaking with: Aric Bendorf on how to increase organ donation rates in Australia

William Isdale, The University of Queensland

Roughly 1,600 people are currently on waiting lists to receive an organ transplant in Australia. But for many, the wait will be unsuccessful due to the low number of donors.

Australia was once a world leader in organ donations, but today its organ donation rate is lower than much of the developed world. The country ranks 20th in the world for donations, despite having a higher than average rate of potential donors, and sits below world leaders such as Spain, Belgium, France and the USA.

Australia’s approach has been to focus on signing up more people to be donors and on encouraging families to consent to donation after the death of a relative. But if Australia wants to be world-leading, that’s not enough.

William Isdale spoke with Aric Bendorf about what needs to change if Australia is to, once again, become a leader in organ donation.

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Music: Free Music Archive/Kai Engel – The Idea

Additional audio: Sunrise (Channel 7), Organ and Tissue Authority, The World Today (ABC Radio National)

The Conversation

William Isdale, Research Assistant, T.C. Beirne School of Law, The University of Queensland

This article was originally published on The Conversation. Read the original article.

If we don’t talk about value, cancer drugs will become terminal for health systems

Narcyz Ghinea, University of Sydney; Ian Kerridge, University of Sydney, and Wendy Lipworth, University of Sydney

More than 100 prominent oncologists from across the United States have called on cancer patients to challenge the high prices charged by pharmaceutical companies for new cancer drugs. They claim drug companies, insurance companies, some patient advocacy groups and many hospitals and physicians are too financially conflicted to be driving the debate.

Their call is motivated by the astronomical prices charged for some new cancer drugs. And Australia is in the same boat. Earlier this year, for instance, the Pharmaceutical Benefits Scheme (PBS) started subsidising pembrolizumab (Keytruda) for the treatment of patients with advanced melanoma. The drug is expected to cost A$150,000 per patient for each year of treatment, which is almost twice the national average annual income.

Unlike in the United States, where patients’ insurance covers the costs, the Australian taxpayer subsidises drugs listed on the PBS. In cases where new drugs are not subsidised, they’re paid for directly by patients, or by state-funded hospitals (often after approval by drug committees). They can also be provided free or subsidised by pharmaceutical companies for “compassionate use”.

Blurred by emotion

Decisions to subsidise drugs and improve their accessibility should be based on an assessment of their value. In Australia, for instance, the Pharmaceutical Benefits Advisory Committee examines new drugs for effectiveness, safety and value for money compared to other treatments before recommending PBS listing – or not.

But the imperative to “save lives” or “beat cancer” — particularly where there’s vigorous public, professional and industry advocacy — can be so profound that it overwhelms the requirement that medicines should be efficacious and cost-effective. This tension between emotional and economic considerations frequently challenges and compromises public decision-making about the value of drugs.

Consider the case of eribulin (Halaven), a drug for treating advanced breast cancer. The UK National Institute for Health and Clinical Excellence (NICE is the rough equivalent of PBAC although it has a broader role) considered the drug but rejected it as too expensive.

Eribulin was subsequently covered by the UK Cancer Drugs Fund, a pool of public money allocated to pay for drugs not approved via the usual route. The price accepted by the fund was among the highest in Europe for the drug; the price rejected by NICE had been the lowest.

Clearly, when standards of cost-effectiveness are reduced in the name of “improved access”, prices can rise arbitrarily. In most markets, supply and demand, competition and consumer choice curtail  such arbitrary fluctuations in price.

But the market for innovative cancer drugs doesn’t follow this pattern because prices can increase dramatically even in “growing” markets, without clear reasons. In 2013, for example, a group of experts in chronic myeloid leukemia described how the price of imatinib (Gleevec) increased three-fold over a decade. This happened even though all research and development costs were accounted for in the original price, and the number of people using the drug was dramatically increasing. Heightened demand alone cannot explain such an increase.

What makes cancer drugs different

Cancer drug markets clearly behave quite differently to what we might expect. There are three key reasons for this.

First, governments are creating a “price deregulation eco-system” for cancer drugs by establishing special funds that challenge accepted standards of value, and by curtailing the ability of payers to negotiate prices. The UK government has the Cancer Drugs Fund discussed above, while US legislation limits the ability of Medicare – the US government’s health insurance program for people who are 65 and older and certain others –
to negotiate drug prices. Laws in the latter country effectively force the health insurer to pay for cancer drugs used for a “medically accepted indication”, and prevent it from considering related cancer drugs as interchangeable.

In other words, US Medicare cannot make the call about whether the drug is worth its asking price, or negotiate prices based on cheaper available alternatives. The fact that the US pays the most for many drugs — including many cancer drugs —  should therefore be no surprise. And if other countries are paying high prices for drugs, it makes it easier to justify these high prices elsewhere.

Second, there’s a lack of significant competition for many new cancer drugs. In an attempt to understand why South Korea paid so much less for drugs used to treat chronic myeloid leukemia — in some instances less than 20% of the US price — the same group of experts mentioned previously noted the country had its own locally discovered drug for treating this disease. The price of competing products appeared to be based on this local drug’s price.

The lack of competition in the cancer drugs market is exacerbated by the rise of new “biological agents”, which are more difficult to replicate than small-molecule drugs, and by industry practices aimed at extending the patent lives of  existing products, thwarting generic competition.

Finally, markets in health care, including for high-cost cancer drugs, are powerfully influenced by existential and moral considerations — specifically fear of death and disability, and desire for greater quantity and quality of life. Cancer patients, their families and the oncologists who care for them are often willing to try drugs in the hope they will work, regardless of the price or prospect of benefit, which is frequently quite limited in the case of new, expensive cancer therapies. And as long as there are people willing to pay high prices or, as is usually the case, to demand subsidised access to cancer drugs, there’s no reason for the industry to reduce its prices.

Hope, fear and desperation, along with the unique characteristics of the cancer drug market, create a “perfect storm” that continues to drive up prices for cancer drugs. Unless we regain sight of the need to use regulatory incentives to reward only genuine innovation, and ensure that we receive sufficient value for the money we spend on new medicines, this upward trend for cancer drug prices is set to continue.

The call by the US oncologists for patients to demand reductions in the price of the new drugs may be too much of an ask as these people have more to lose in this debate. It may also be too narrowly focused as it’s not just cancer patients but all of us who should demand the drugs we need at a price that our publicly funded health systems can afford.

CORRECTION: This article has been amended to reflect the fact that the PBS lists subsidised drugs, not the Therapeutic Goods Administration it said originally.

The Conversation

Narcyz Ghinea is Postdoctoral Research Associate, Centre for Values, Ethics and the Law in Medicine at University of Sydney.
Ian Kerridge is Associate Professor in Bioethics & Director, Centre for Values and Ethics and the Law in Medicine at University of Sydney.
Wendy Lipworth is Senior Research Fellow, Bioethics at University of Sydney.

This article was originally published on The Conversation.
Read the original article.

Politics, Power and Children in Detention

Politics are all around us, playing out in national, local and even domestic governance. Politics have to do with the polis, the people who make up groups of any kind. In that sense, politics are unavoidable. Our relationships with others always contain a political element. Party politics are a subset of politics in its broad sense. Party politics are partisan, ideologically informed patterns of thought and action that suggest how politics should translate into governance in a way that is consistent with a set of underlying values. They condense around different beliefs in power relationships between governors and governed, in the rights and statuses of the different groups that make up the polis, in the control and dissemination of information, and in the responsibilities of government and individuals towards one another.

Accommodation in the Nauru offshore processing facility.

Accommodation in the Nauru offshore processing facility.

Party politics is made up of what Gallie termed ‘essentially contested concepts’. No one, for example, disputes the existence of the multitudes of people fleeing poverty, instability, persecution and fear. Nor do they dispute the reality of the moral and practical problems they pose for the countries to which they try to flee. But the agreements end at about this point. Some interpret this mass movement as a challenge to their sense of humanity and to their obligations to observe human rights. Others, while acknowledging the human problems of displacement, feel that local territorial rights and laws take precedence, and that the welfare of the host countries is paramount. Turning unregistered and unscreened refugees (“illegals”) away is, in that ideology, a better and safer and fairer alternative to dealing with them by taking them in.

Australia has been foremost among western countries in ‘turning back the boats’ and in making off-shore detention inevitable for those who do manage the journey, pointing to the success of that policy in preventing drownings and restricting the numbers of refugees who reach Australian territorial waters. By contrast, Italy has done its best to rescue enormous numbers of people fleeing North Africa, and to find some kind of accommodation for them. Neither side can be said to have found ‘the’ answer to a massive humanitarian crisis. Italy’s resources have been overstretched. The Australian mode of management appears to contravene United Nations conventions on refugees.

Party-Politics & the Report into Children in Detention

Into the middle of this dilemma, which is partly political in the broad sense and strongly party political in a narrower sense, came the Report into Children in Detention, chaired by the Australian Human Rights Commissioner, Gillian Triggs. The Report found more than 200 children to be in off-shore or Australian detention under conditions that harm their development and infringe the UN statements on human rights. The Commission’s findings seem to be supported by doctors who have visited the detention centres, and by various leaks from people who have worked in Nauru and Christmas Island. The Australian Government’s response has been to deny the accuracy of the report, to attack Triggs’s integrity, to accuse her of partisan reporting, and to call for her resignation.

The report calls for the early release of children from detention, and for proper acknowledgement of their rights, particularly their rights to grow into reasonable adulthood, equipped with education and some sense of identity and stability. It makes many comments about the suffering of adults, but its focus is on children and the overwhelming impact that violence, insecurity, uncertainty, heat, lack of space and lack of hygiene will have on their lives.

The report does not deal so much with the original party-political decision to turn back the boats. It does take issue with both political parties’ decisions to enforce mandatory detention, and it does so predominantly in the context of the impact of that policy on children.

Triggs & the Ruin of Party-Politics

It makes disturbing reading. Presumably that is why it has provoked such extreme responses from both sides of party politics.

On the right, party politicians and right-wing newspapers have belittled Triggs and accused her of bias against them, of dishonesty and inaccuracy. They question the timing of the inquiry, which began soon after the election of the LNP in 2013. They have recommended imprisonment for anyone who leaks relevant information to the media, such as those who supplied some of the information that Triggs relied upon.

On the left (and in the centre), politicians, commentators and media have called for the report to be taken seriously, for secrecy to be lifted and for legislation to protect refugee children. For these people, the timing of the report is irrelevant because its contents demand some major response. At the same time, those who oppose the present government’s theories and practices have used the report as a lever to destabilise the government’s refugee policies more generally, pointing out that what happens to the children is a consequence of what happens to “illegal” refugees at large.

All these conflicts of interpretation and accusations of dishonesty signal the presence of an essentially contested concept. The big concerns for us are:

  1. That politics in the broad sense have been confused with a much narrower party politics;
  2. That the present government’s refusal to allow access to the detention facilities effectively disables any public debate;
  3. That the punishments threatened against anyone who reveals ‘classified’ information about the centres are Draconian;
  4. That the government’s vigorous attacks on the report and its author suggest that they had a pre-formed notion of what the report should say.

Essentially contested concepts make up a significant part of our ‘political’ lives – they always have and they always will. What is important is the way in which these contests are handled. A totalitarian government will settle them one way; a liberal democracy will try to find another.

Ignoring the Real Issue

What is at stake in this confrontation is not Gillian Triggs’s credibility, but the public perception of its preferred mode of government. Apparently, more than 50% of the population approve the present government’s approach to refugees or believe that it should be more extreme. We can only hope that they understand that Triggs, in her appointed role as Human Rights Commissioner, was writing about children in detention, and that government decisions to discredit her well-supported findings by political force majeur raise serious concerns about the reality of our much vaunted participatory democracy.

Emeritus Professor Miles Little, University of Sydney

Miles was the Founding Director of the Centre for Values, Ethics and the Law in Medicine (1996-2003). He was also the Foundation Professor of Surgery at Westmead Hospital in 1978 and a Co-Founder of the World Association of Hepatic, Pancreatic and Biliary Surgeons (1987). Since 1996, Miles is an Emeritus Professor of Surgery at the Sydney Medical School. At the VELiM, he continues to teach and is directing the Cancer Survivorship Project. Miles interests include Medical Sociology and Biomedical Ethics. He is also a published poet.

How we can increase Australia’s organ donation rate

Aric Bendorf, University of Sydney; Ainsley Newson, University of Sydney, and Ian Kerridge, University of Sydney

The Australian government has commissioned a private consultancy to review the country’s poor organ donation rates. While the review may make some interesting observations, the answer to increasing the rate is already clear: we need to better manage patients nearing brain death.

In 2008, the Rudd Labor government allocated A$136 million to create a nationwide government body called the Organ and Tissue Authority (OTA), and charged it with increasing Australia’s low deceased organ and tissue donation rates.

The initiative failed. After initially increasing rates to our highest-ever of 16.9 deceased organ donors per million population (pmp) in 2013, the rate fell again to 16.1 in 2014. And our year-to-date projections point to a further decrease in this rate for 2015.

Even though there has been a small relative increase in the number of people who have received transplants – 56.3 transplants pmp in 2008 to 58.9 transplants in 2014 – this 4.6% increase has cost more than A$250 million. And Australia’s donation rate remains in the bottom half of developed countries, with a rate less than half that of world-leading Spain.

The OTA’s failure to achieve higher donation levels or to maintain its early improvements raises questions about its strategic approach. We believe there are three key areas where its approach differs from world’s best practice.

1. A focus on donation after cardio-circulatory death has decreased the number of organs available for transplant

The kinds of deaths that can lead to organ donation are very rare; they typically comprise around two in 100 deaths. There are two main kinds of “eligible” deaths. The first, and most common, is donation after brain death. People who are brain dead can normally donate many organs because even though their brain is dead, their heart continues to beat and their organs remain viable for transplant.

The second is donation after cardio-circulatory death, which is donation after the donor’s heart stops beating under controlled conditions in hospital. Because circulation has ceased, the number of organs able to be retrieved is normally fewer than that following brain death; they donate, on average, 1.5 times fewer organs than brain dead donors.

Under the OTA, Australia’s level of donation after brain death has increased by 4.5% (from 11.04 pmp donors in 2008 to 11.54 pmp in 2014), while donation after cardio-circulatory death has increased by 422% (from 1.08 pmp in 2008 to 4.56 pmp in 2014). This picture is completely different to countries with world-leading donation rates, all of which have greatly improved their donation after brain death rates relative to their donation after cardio-circulatory death rates.

The OTA’s focus on donation after cardio-circulatory death may well have come at the expense of donation after brain death. And this has potentially reduced the number of organs available for transplantation. While technological advances, including “re-animation”, will likely reduce barriers to organ retrieval from non-heart-beating donors, changing the focus from donation after cardio-circulatory death to donation after brain death still represents the most effective way for improving organ donation rates in this country.

2. Publicity campaigns to increase public support for organ donation have wasted resources and are unlikely to achieve significant long-term benefit

It may sound counter-intuitive but high organ donation rates don’t correspond with public support for organ donation. In fact, many countries with the world’s highest organ donation rates have among the lowest public support for donation, which suggests public education campaigns are unlikely to significantly improve organ donation rates.

But each year the OTA spends significant resources trying to increase community awareness through advertising, public relations and merchandise. These efforts include “Have you had the chat that saves lives,” the DonateLife Corporate Partnership Program and other public outreach campaigns.

While such campaigns may have high public, media and political profile, there is little evidence they directly influence organ donation rates.

A focus on donation after cardio-circulatory death has decreased the number of organs available for transplant.
Dmitry Kalinovsky/Shutterstock

It’s noteworthy that many world-leading donor countries, including Spain (which has approximately twice Australia’s population), provide considerably less financial support for their equivalent national organ authorities. In 2015 the Spanish ONT – Spain’s equivalent of the OTA – received the equivalent of A$5.66 million for its total funding, whereas the OTA has a budget of approximately A$40 million. Spain’s donation authority has little to no budget for advertising, public relations or marketing and relies primarily on systematic organisation of the health-care system to support organ donation.

3. Focusing on consent to donation doesn’t yield the same benefit as early identification of potential donation after brain death donors

Australia’s 2014 consent rate (the percentage of families who give their consent to donate their loved one’s organs) of 61% is almost identical to that of France and similar to many other countries with world-leading deceased organ donation rates. Clearly, while consent plays an important role in the success of any organ donation program, it’s not the main determinant of whether a country achieves high organ donation rates.

Politicians, policymakers and transplant advocates have also raised the prospect of making it impossible for families to veto a potential donor’s expressed wish to donate their organs. But this may be counterproductive. It may increase family distrust and alienation regarding donation. And it’s unnecessary as virtually all countries with world-leading organ donation rates allow families to veto organ donation.

In fact, there’s only one factor that determines whether or not a country will have a high deceased organ donation rate and that’s how often it treats critically ill patients until they reach brain death. International data suggests it’s impossible to raise organ donation rates to more than 20 donors pmp population without implementing effective programs that focus on effectively identifying critically ill patients who may be approaching brain death.

Increasing donation after brain death

Australia has struggled to increase its deceased organ donation rates for more than 25 years. To achieve better rates, the OTA must shift its focus away from public awareness campaigns and instead focus on improving effectiveness in early identification of critically ill patients who are likely to become brain dead.

The conditions that lead to brain death are just as prevalent in Australia as they are in other leading donor countries. Indeed more Australians die from traumatic brain injury – the primary cause of death for donation after brain death donors in Australia – than in many other world-leading donor countries. This indicates the potential for Australia to achieve world-leading organ donation rates is real. The clinical identification of brain death must, of course, go hand in hand with appropriate, timely and sensitive discussions with a patient’s loved ones.

It is up to the OTA to lead on this potential and help the Australian medical community identify cases of brain death more effectively, and increase the number of organs being donated.

The Conversation

Aric Bendorf is Postdoctoral Research Fellow at the Centre for Values, Ethics and the Law in Medicine (VELiM) at University of Sydney.
Ainsley Newson is Senior Lecturer in Bioethics at University of Sydney.
Ian Kerridge is Associate Professor in Bioethics & Director, Centre for Values and Ethics and the Law in Medicine at University of Sydney.

This article was originally published on The Conversation.
Read the original article.

Waste not, want not: new organ donation policy could save lives

By Aric Bendorf, University of Sydney and Ainsley Newson, University of Sydney

Australia has never had a great deceased organ donor rate – and it fell last year. But proposed guidelines from the National Health and Medical Research Council (NHMRC) could change how donor organs are obtained and allocated for the better.

DonateLife Australia, the government body responsible for organ donation and transplantation, has just announced there were 16.1 deceased organ donors per million people in Australia in 2014. This represents a 5% decline from 2013 and maintains Australia’s deceased organ donor rate in the bottom half of OECD countries. It’s important to note, though, that the 2013 rate was the highest ever recorded.

More people in this country die waiting for organ transplants than in many other developed countries, but it’s not all bad news: Australia has a long and successful history in organ transplantation.

Outcomes following organ transplantation are world leading – more than 90% of patients who receive a kidney, heart, heart-lung or liver transplant are alive a year later. And more than 90% of people who receive a transplant have normal function of their new organ. The number of organs retrieved from each deceased donor is also higher than in many countries.

Continue reading

There’s more to Pradaxa’s problems than meets the eye

By Wendy Lipworth, University of Sydney and Ian Kerridge, University of Sydney

Pharmaceutical companies don’t have a particularly good reputation, for some very good reasons. But we can’t let suspicions about the motives of such companies cloud our assessments of drug safety because patients may also suffer.

People with abnormal heart rhythms and other diseases that cause blood clots (thromboses) often require blood-thinning (anticoagulation) medications. For many decades, warfarin has been the most widely used such drug but it’s associated with a risk of bleeding (including fatal haemorrhage) and requires regular blood tests to monitor safety and efficacy.

So the advent of new oral anticoagulant drugs was heralded as a major advance by both patients and clinicians – principally on the grounds that they appeared as effective as warfarin, may be associated with a lower risk of serious bleeding, and are cost-effective because patients don’t need ongoing blood monitoring.

For these reasons, a number of these new drugs, including dabigatran (Pradaxa) and rivaroxaban (Xarelto) were fast-tracked through the regulatory approval processes in the United States and in New Zealand. Continue reading

Why care about the health and well-being of asylum seekers?

By Stacy Carter, University of Sydney and Ian Kerridge, University of Sydney

A report on the refugee detention centre in Nauru by five independent clinical experts posted online by The Guardian on Friday paints a bleak picture of life on the island, particularly for children. But why should we care about how these people are being treated?

The report describes the now-familiar wretched conditions of refugee detention. Tents that leak in the rain and become unbearably hot and humid by 10am. Burning white rocks underfoot, little natural shade, dust everywhere, only electric fans for cooling in most areas of the camp.

Mosquitoes that prevent sleep and may carry diseases. Overwhelming boredom. And the hopelessness, helplessness, frustration and despair that accompany radical uncertainty about the future.

The authors detail the effects of this environment on the physical and mental health of asylum seekers. And, not unexpectedly, they recommend changes to the detention centre. This implies, of course, that current conditions should change; that the damage we are doing to these adults and children is unacceptable.

But the Australian government disagrees. It claims current policy is justified because it prevents asylum seekers from dying at sea. Let’s assume for a moment that this is truly the purpose of offshore mandatory detention. The goal – preventing deaths – is worthy, but what means are justified to reach it? Continue reading