

William Isdale, The University of Queensland






Music: Free Music Archive/Kai Engel – The Idea


The Conversation




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.
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


Accommodation in the Nauru offshore processing facility.

Accommodation in the Nauru offshore processing facility.



Party-Politics & the Report into Children in Detention




Triggs & the Ruin of Party-Politics







Ignoring the Real Issue


Emeritus Professor Miles Little, University of Sydney


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.

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.

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


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





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