Fear and Hypocrisy in Australia: Immigration Detention and Free Speech

It was not long ago that the Abbott government vowed to champion free speech, pledging to amend Section 18C of the Racial Discrimination Act, a section of the act that made almost completely useless speech illegal. This commitment was re-affirmed a number of times, including again in early 2015 after the Charlie Hebdo massacre. It seems however the government’s commitment to free speech is largely selective, actively working to keep the marginalised and powerless out of the debate, happy to gag and attack those who dissent.

The recently introduced Border Force Act has raised the ire of a number of individuals and professional bodies, gaining significant media attention with a possible two year prison sentence for speaking about the conditions in immigration detention. Much has been said about how this will impact on the ability of health professionals to report abuse and advocate for patients, however less has been said about how this will only further silence those who are genuinely voiceless.

Silencing the Silenced

The stories we hear from within detention centres are often told through third parties, with many former employees feeling compelled to speak on behalf of those who could not. For all the noise surrounding immigration detention policies, how many of those voices are refugees or asylum seekers?
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Hannah Arendt explored this powerlessness in The Origins of Totalitarianism, she argued that even though human rights are proclaimed to be universal, asylum seekers and stateless persons were left with nothing to protect their rights, effectively in limbo, no longer a member of a community where their rights could be enforced. This precarious situation has often been referred to as “the right to have rights”.

“… but it turned out that the moment human beings lacked their own government and had to fall back upon their minimum rights, no authority was left to protect them and no institution was willing to guarantee them.”

She emphasised how this stripped away the right to make oneself heard and opinions matter.

“The fundamental deprivation of human rights is manifested first and above all in the deprivation of a place in the world which makes opinions significant and actions effective… They are deprived, not of the right to freedom, but of the right to action; not of the right to think whatever they please, but of the right to have an opinion”

Managing and processing the powerless

Immigration detention in Australia compounds this powerlessness by further limiting asylum seekers ability to control their own lives and speak candidly about their circumstances. Andre Dao reminds us that this powerlessness can manifest in asylum seekers gambling on their bodies, a symbolic way to regain some control, to be heard. As Dao puts it “you are no longer a human being with free will. Instead, you’re a problem to be managed, an object to be processed.” Few better statements sum this up than these words recalled by an ex-detainee on a hunger strike who was being spoken to by a department employee.

“You understand that your life is in our hands. Your death is also in our hands because we won’t let you die.”

Although a number of asylum seekers have spoken out over the years, their voices rarely make it to the mainstream. Furthermore there remains the expectation of silence both during and after detention, it is not until permanent residency has been gained and families reunited that many feel safe to speak about their experiences.

Silenced subjects and misinformation

Maintaining this silence is key to maintaining our current approach to asylum seekers. The system has been built around rhetoric and misinformation, from children overboard to the present day. Most people can bark back three word slogans, but fewer could tell you what percentage of the world’s asylum seekers arrive on our shores or begin to explain the trauma and torture many have faced before finding safety.

The voices we most need in our debates around asylum seeker policy in Australia are absent, not only that, they are actively excluded. So as well as threatening professionals with gaol time, the Border Force Act only further ensures that that we never get to hear these stories, it ensures that we don’t know who we are locking up or for what reason.

It’s not obvious how the Border Force Act serves to “stop the boats” or “smash the people smugglers business model”, taking into account the boats stopped a long time ago. In attempting to justify this legislation however, the rhetoric has boiled down to a very familiar means justifying the ends rationale, something we should all be careful of and something where it seems appropriate to leave the last words with Hannah Arendt.

“The crimes against human rights, which have become a speciality of totalitarian regimes, can always be justified by the pretext that right is equivalent to being good or useful for the whole in distinction to its parts.”

Ryan Essex

PhD Candidate, The University of Sydney.

EVENT: Symposium on Academic Publishing and the Futures of Research

Image taken from page 213 of 'Queen Mab. A novel'
The Centre for Values, Ethics and the Law in Medicine (VELiM) is hosting an event on the academic publishing industry and the commercialization of knowledge production.

In recent years there has been a lot of self-reflection about the effects of neoliberalism on the university and the practices of teaching and research. This symposium will focus on academic publishing and the impacts of paywalls on academic practices, but also democratic access to knowledge required for policy-making and informed public debate.

Speaking to The Guardian, Dr Claire Hooker outlined some of the concerns associated with current academic publishing practice, saying:

There are people out there who are worried about the effects of medicines, or who want to know more about the evidence informing the health policies that affect them, but they can’t find the answers because they hit a paywall.

Professor Paul Komesaroff (Monash), who will also be part of the symposium, argues that more open and democratic models of publishing are needed. According to Komesaroff, scholars are looking for these models. However, it appears that the current institutional arrangements and intensives make it difficult to imagine alternatives.

The symposium looks to explores some of these alternatives. For more information see the below.

Reclaiming the Knowledge Commons
The Ethics of Academic Publishing and the Futures of Research

Type: Seminar
Date: Wednesday 26 August 2015
Time: 9.00 AM to 4.00 PM
Venue: State Library, Mitchell Wing
Cost: Free
Click here to book

Speakers include: Emeritus Professor Stephen Leeder, Professor Paul Komesaroff, Associate Professor Andrew Bonnell, Dr John Byron, JoAnne Sparks, Dr Virginia Barbour, Rosalia Garcia (SAGE), and Professor Christopher Wright.
Chair: Dr Claire Hooker

The symposium will comprise four sessions:

  • 9:00-10:30 Session 1: Corporatization and the commercialization of knowledge
  • 11:00-12:00 Session 2: Democratizing knowledge or selling the farm? The emergence and challenges of ‘Open Access’
  • 12:00-1:00 Session 3:  Dissolving barriers – and boundaries: Scholars and the possibilities of the new digital knowledge commons
  • 2:00-4:00 Session 4: Taking up the challenge of ethical academic publication

Catering is provided

For more information please contact;
Centre for Values, Ethics and the Law in Medicine
T +61 410 161841 | E velim.event@sydney.edu.au

On Not “Getting Out of the Way”: A Reflection on Steven Pinker’s Critique of Bioethics

Title:

Last week well known psychologist, linguist and author Steven Pinker published an op-ed in the Boston Globe, under the title “The Moral Imperative for Bioethics”.*

The article begins with an explicit mention of the CRISP-Cas9 technique for “editing” genomes, and a brief tour through the many diseases which modern medicine and biotechnology is seeking to treat. He goes on to say that research in these areas is essential, a point he frames in terms of reducing the global burden of disease. He then says:

Biomedical research, then, promises vast increases in life, health, and flourishing. Just imagine how much happier you would be if a prematurely deceased loved one were alive, or a debilitated one were vigorous — and multiply that good by several billion, in perpetuity. Given this potential bonanza, the primary moral goal for today’s bioethics can be summarized in a single sentence.

Get out of the way.

Now this is pretty striking, and unsurprisingly many commentators, including myself, were furious. However, I thought I would let the dust settle and see what emerged from the discussion on social media, an email discussion list I am a member of and elsewhere. The stories in Nature and PopSci were reasonable, and Alice Domurat Dreger, Julian Savulescu, Stuart Rennie, Christopher Mayes, Matthew Beard and Russell Blackford make good points.

One point of common ground here, and indeed with Pinker, is that there really is a problem with much bioethics regulation – the processes of research governance and ethics committee oversight. It can be slow, cumbersome, unpredictable, perverse, contradictory and so on. But even so, no one is suggesting we dispense with it altogether – only that it be improved. Pinker himself says:

Of course, individuals must be protected from identifiable harm, but we already have ample safeguards for the safety and informed consent of patients and research subjects.

He also points out, later on in his article, that biomedical technologies which sometimes seemed very promising often fail:

Biomedical research in particular is defiantly unpredictable. The silver-bullet cancer cures of yesterday’s newsmagazine covers, like interferon and angiogenesis inhibitors, disappointed the breathless expectations, as have elixirs such as antioxidants, Vioxx, and hormone replacement therapy.

It is interesting that several of the technologies he mentions didn’t just fail, their failure was often covered up by manufacturers and the regulatory system designed to catch these failures arguably didn’t intervene quickly enough. He doesn’t mention this however; his argument the quasi-libertarian one that scientists should be allowed freedom to explore and innovate without excess regulation. He is less good at noticing the ways in which such innovation takes place in economic conditions which make regulation essential to cope with market failures.

He has two basic arguments for the need for bioethics to get out of the way:

First, slowing down research has a massive human cost. Even a one-year delay in implementing an effective treatment could spell death, suffering, or disability for millions of people.

And:

Second, technological prediction beyond a horizon of a few years is so futile that any policy based on it is almost certain to do more harm than good.

To the first, while on its face it looks plausible, if his second argument is valid, then the problem is we just don’t know whether the research we are doing now actually will save all those lives. Indeed, by investing in this research and not that we may be wasting all those lives he points to. We just don’t know. As to the second, it is almost trivially true, but nonetheless these predictions are what policy-makers and research funders and investors (not forgetting the rest of us) have to make. But he says:

In the other direction, treatments that were decried in their time as paving the road to hell, including vaccination, transfusions, anesthesia, artificial insemination, organ transplants, and in-vitro fertilization, have become unexceptional boons to human well-being.

In other words, some of our bets paid off, some didn’t, and sometimes some of us bet the wrong way on the basis of moral objections which in hindsight look ridiculous. It’s not clear to me why bets the wrong way on other grounds than moral ones get a free pass, but only moral qualms get mocked in this way. I am sure we can make a list of bets the wrong way where moral qualms ought to have played a part and didn’t so we ended up with disastrous consequences for millions. Again, he doesn’t talk about that. The trouble with consequentialist (or decision theoretic?) reasoning of Pinker’s type is that you have to count all the consequences of all the options, not just the ones which favour your own biases. Indeed, if you are going to be a consequentialist you have to be rather good at predicting outcomes (not as bad as he says we are, in other words). But in any case, he reserves special opprobrium for moral reasoning, thus:

Biomedical advances will always be incremental and hard-won, and foreseeable harms can be dealt with as they arise. The human body is staggeringly complex, vulnerable to entropy, shaped by evolution for youthful vigor at the expense of longevity, and governed by intricate feedback loops which ensure that any intervention will be compensated for by other parts of the system. Biomedical research will always be closer to Sisyphus than a runaway train — and the last thing we need is a lobby of so-called ethicists helping to push the rock down the hill.

My initial reaction to the Pinker article was heated. I have spent my entire working life as a bioethicist (roughly speaking, from my first postdoc, as I was not in bioethics as a graduate student or before) with people claiming that what I do is variously a waste of time, a waste of money, ideologically suspect (from any and all directions), intellectually sloppy and so on. Sometimes these criticisms have been levelled at me personally (fine, I can bite back if I need to, and I’m not perfect and sometimes the criticisms have been fair), sometimes at my work (that’s the academic life, I can take it) and sometimes they have been levelled at me and my peers _merely_ because of presumed attitudes, beliefs and values I must have simply because I am a “bioethicist” and “this is what bioethicists think”. Sociologists often do this (not all sociologists…) and historians of medicine often do this (not all historians…). It’s tiresome. If someone wants to know what _I_ think there are various ways of finding out, but a priori judgements of what I “must” think because I am a bioethicist really… get my goat.

My initial reaction to Pinker’s article was that it was an egregious piece of grandstanding which if it had come from the wilder shores of twitter we’d call trolling. However, that would be to attribute motives and intentions to Pinker I cannot verify. What I can say is that it is in a reasonably well established genre of writing which appears quite frequently in the professional medical press (for example, an unsigned editorial about 15 years ago in the Lancet titled “the ethics industry”), and it is perfectly reasonable and sensible to look at the writing as a genre piece, focus on its rhetoric, implied audience and so on. We should also look directly at the arguments, and when I’d cooled off and read Julian and Alice’s pieces I can see that there are arguments in Pinker’s article which have merit and I agree with them. But still, the rhetoric matters. Just as if I am parking my car and someone comes up in my face and shouts “get out of the way” I am liable to take that as a verbal assault even if he then gives me some good and compelling reasons why I might like to move my car a little. This person knows the effect of getting in my face and shouting at me, and it has little to do with the merit of his argumentation. Authors of style guides are pretty good at knowing how rhetoric works too. So are linguists and psychologists.

Never mind. I will get over it. I don’t have to take it personally, after all I don’t recognise myself in his description of bioethicists, so presumably he’s not talking about me anyway. (He wouldn’t know me from Adam).

Turning once more to the arguments, the one argument which has not been touched on directly, and I think is important, is that he says bioethics should not thwart:

…research that has likely benefits now or in the near future by sowing panic about speculative harms in the distant future. These include perverse analogies with nuclear weapons and Nazi atrocities, science-fiction dystopias like “Brave New World’’ and “Gattaca,’’ and freak-show scenarios like armies of cloned Hitlers, people selling their eyeballs on eBay, or warehouses of zombies to supply people with spare organs. Of course, individuals must be protected from identifiable harm, but we already have ample safeguards for the safety and informed consent of patients and research subjects.

Several commentators have questioned whether we can be that sanguine about how well bioethics does the latter. But it’s the former that bothers me. He’s making an asymmetrical argument: we should discount hypotheticals about bad things; but instead be guided by hypotheticals about good things. To my way of thinking they are no less hypothetical. There’s a branch of the sociology of knowledge which explores this in some detail, the sociology of expectations, and one of the main findings in that field is the biomedicine relies on creating narratives about plausible social futures of technologies in order to attract investors and research funders, persuade regulators and so on. No one, nowadays at least, ever chucks money at researchers saying, go and do something interesting, tell us when you’re done.

So my more general point is that bioethics is _precisely_ a way of telling stories about new technologies and exploring them and seeing what we make of them. There are other ways to do this – for example, as Pinker’s own example shows, making films, writing novels and stories, and so on. Or indeed writing business plans, IPOs and suchlike. This is how humans think stuff through. It’s part and parcel of how we make technologies. It’s not an extraneous factor, that can be shoved out of the way. So, once again, rhetoric matters, and not as a bit of optional packaging, but as part of the real work itself.

Some day I am going to write a book about this. Maybe I should thank Pinker for getting my introduction going with a bang.

Richard Ashcroft

Professor of Bioethics
School of Law

Queen Mary University of London

@qmulbioethics

*Pinker has since made further comments found here.

Richard visited VELIM in February 2005 while he was on an Australian Bicentennial Fellow visiting the Centre for Applied Philosophy and Public Ethics, University of Melbourne. He and Dr Ainsley Newson were colleagues at Imperial College London.

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.

Policing parenting: is the Family Court going to punish you for having a drink?

Sascha Callaghan, University of Sydney

News outlets have pounced on a Family Court “order” for parents of a six-year-old boy to not smoke around the child and to limit their alcohol consumption while caring for him. Readers commented that the case represents an unacceptable “intervention by the courts into the personal space of the individual”, and that it was an attempt at “social engineering”.

The idea of a court intervening in family life to prevent what might seem like fairly ordinary activities, such as occasional tobacco smoking or having a glass of wine or two, might seem like evidence of an overreaching “nanny state”. And perhaps it would be if that’s actually what happened – but it didn’t.

It is true, though, that the “right to parent” according to one’s own values and proclivities isn’t actually unfettered. The state can and will intervene in family life in various circumstances.

A definite jurisdiction

State Supreme Courts have powers to make orders under their protective jurisdiction to allow important medical treatment to go ahead if parents won’t consent, for instance. The NSW Supreme Court did exactly that in a 2013 case where a Jehovah’s Witness parent refused a life-saving blood transfusion on behalf of their child.

State agencies can also intercede in family life under child protection laws when a child is at risk of significant harm. This kind of coercive intervention is reserved for serious cases where the child’s basic needs are not being met. And it generally requires much more than a parent who smokes or drinks too much from time to time to trigger intervention.

But child protection laws have also been invoked when parents of a severely overweight boy didn’t go to hospital for treatment, or appropriately manage his diet (the ten-year-old boy later died from heart failure associated with obesity). And when a father, who believed HIV was an invention of pharmaceutical companies, refused to give his child the antiretroviral medication prescribed by doctors.

Not everyone will agree on the limits drawn around decisions parents are allowed to make. But most will agree that the public interest in protecting children means limits must be placed somewhere. And “risk of significant harm” doesn’t seem like a bad starting point.

In addition to child protection laws, the Family Court will intervene in the parenting of children when asked to do so by parents who cannot agree on the relevant decisions themselves. In settling these disputes, the guiding principle is that the court will act to protect the “best interests of children”.

But how do courts interpret this rather wide concept, and where do the limits of personal parental prerogatives lie when a court tries to strike a balance between the strongly held views of parents who bitterly disagree?

The particular case

In the case that has provoked so much comment, the Family Court decided that despite the fact the child’s mother was his primary carer and was “utterly dedicated to the child’s needs”, it would be in his best interests to live with his father.

The Family Court will make parenting decisions when asked to do so by parents who can’t agree on the decisions themselves.
from shutterstock.com

The orders were influenced by the mother’s preference for the advice of her naturopath over an accredited medical practitioner, which the court found was to the detriment of the child; her “conscientious objection to vaccination”; and her “clear and unwavering belief that the child obtains nothing from an ongoing relationship with his father”.

The father, on the other hand, appeared to the court to have a better view of the child’s medical needs and was “the parent more likely to support [the child] in his relationship with his mother”.

Among the 45 orders the court made were two proposed by the mother – that both parents be “restrained from smoking in the presence of the child” and that they will refrain from consuming alcohol “to excess”, or at least to the point of being unable to drive, while the child is in their care. The father agreed to these, in a suite of orders in which his interests mostly prevailed.

These are known as “consent orders” – and they’re quite different to coercive interventions under child protection laws. In fact, health-related agreements are becoming a common feature of consent orders in a culture that increasingly values health and wellness, and in which many parents are likely to want assurances from the other that their child will be in a “healthy” environment when not in their care.

These kinds of concessions are negotiated in families every day of the week – “take Harry to the physio”, or “please can we not have pizza again because last time Sam got sick”. In this sense, consent orders reflect familiar family compromises and the parents’ own values – rather than an out-of-control nanny state imposing orders on passive parents.

It’s just that these fairly unremarkable agreements have been written down and stamped by the court because goodwill has evaporated and parents no longer trust each other to honour everyday deals.

The long arm of the law?

Indeed, the most interesting aspect of this case is perhaps not the agreement by both parents not to smoke in front of their child or get so drunk that they can’t drive, but that in determining a child’s best interests, the overriding priority for the court was securing “the benefit to the child of having a meaningful relationship with both of the child’s parents”.

To many people the idea that a father who had never been in a stable relationship with the mother and had little previous involvement with him should be entitled to a relationship with the child to the extent that his mother’s role as primary carer was lost, would seem ludicrous. But the Family Law Act takes the position that a relationship with both parents will, in the absence of risk of harm to the child, be considered paramount.

With regard to smoking and drinking, there was agreement between the parents with the imprimatur of the court – rather than an order being “imposed”. The most serious issue that remained in dispute was the child’s right to a relationship with both his parents – and this was where the court really did impose the values of the Family Law Act.

Otherwise, unilateral state intervention is reserved for much more serious cases where significant harm is in the offing. So, you can still have a smoko while your child is at home without fear of being touched by the long arm of the law.

The Conversation

Sascha Callaghan is Lecturer in Health Law & Bioethics at University of Sydney.

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

It’s time for the government to stop shooting the messenger

Sydney Health Law

The constant attacks on Professor Gillian Triggs represent attacks on the human rights and civil liberties that Australians value. Since 1986, the Human Rights Commission has been the watchdog for human rights for Australia.  The President and her Commissioners are necessarily independent of government and have a duty to fearlessly advocate for human rights protections and to criticise laws and policies that undermine the rights and freedoms Australians enjoy.

The current barrage of orchestrated attacks on Triggs is supposedly on the basis that her comments are politically motivated. Of course they are. Human rights lie at the core of our political system: they require government to protect their population and provide a political environment in which they can flourish. If human rights weren’t political they would make no sense at all.  The problem for the government is that it wants to ignore human rights yet remain immune from criticism.

The…

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Propaganda or cost of innovation? The high price of new drugs

Propaganda or cost of innovation? The high price of new drugs

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

Ever wonder how much it costs to develop a new drug? The independent, non-profit research group, The Tufts Center for the Study of Drug Development, estimates US$2.6 billion, almost double the centre’s previous estimate a decade ago. But how accurate is this figure?

While the details of the study remain a secret, a press release, slideshow and background document on the Tufts website provide some insight into how this figure was calculated. Interestingly, only slightly more than half of this cost is directly related to research and development (R&D). US$1.2 billion are “time costs” – returns that investors might have made if their money wasn’t tied up in developing a particular drug.

As expected, these costings have attracted the attention of policymakers, consumer advocates and critics of big pharma. In the New England Journal of Medicine, Harvard University Professor of Medicine Jerry Avorn questions several assumptions underpinning the Tufts costing – particularly the unverifiable claim that up to 80% of compounds are abandoned at some point during development.

Avorn is also unconvinced by the Tufts assertion that an annual return on capital of 10.5% (which was used to calculate the “time costs” component) is needed to attract investors, noting that “bonds issued by drug companies often pay only 1 to 5%”.

More broadly, Avorn questions the Tufts claim that its US$2.6 billion figure related to only “self-originated” products and wonders whether this includes contributions from the public purse for underlying basic science. If the Tufts figure didn’t include public contributions to research, the real cost of drug development would be even higher.

Finally, Avorn notes that pharmaceutical companies could fund much of their research themselves with the hundreds of billions of their own (untaxed) capital held outside of the United States.

Avorn’s criticisms echo those of the Union for Affordable Cancer, which complains that the study’s figures are already being used as a propaganda tool to justify high drug prices, particularly for cancer.

Like Avorn, the Union suggests that the Tufts figures also ignore the significant public contribution to drug development, particularly for cancer.

Others have argued the Tufts figure is grossly over-inflated. Rohit Malpani, director of policy and analysis at Doctors without Borders notes drugs can be developed for as little as US$50 million, and at most, for US$186 million when failures are taken into account.

Even Industry heavyweights such as GlaxoSmithKline’s CEO Andrew Witty have undermined the Tufts claims by suggesting in 2013 that the US$1 billion dollar figure was a myth.

So why is this debate important and why does it matter whether or not these estimate are correct?

These costs are used to justify high drug prices. These prices increasingly have the potential to disable health-care systems, create enormous opportunity costs (as funds that could be spent on other goods and services are diverted to purchase more and more expensive drugs), and place medicines out of reach of all but the most wealthy individuals or governments.

This is a reminder that the real issue is not how much it costs to develop a drug, but whether or not these drugs are worth the high prices pharmaceutical companies charge for them.

While advocates of a completely free market might see “just” pricing and all forms of price control as “medieval”, “socialist” or as suppressing innovation, others worry that drug prices bear little, if any, correlation with actual clinical value.

Rewarding innovation is necessary, but allowing drugs to be priced according to whatever the market will bear, rather than according to their benefits and cost-effectiveness, leads to inefficiencies, inequities and dramatic global inconsistencies.

Knowing how much it really costs to develop a drug might make it easier to negotiate drug prices on a global level and make revenues more predictable. This would not only be beneficial for society but could also ensure more predictable returns for the pharmaceutical industry.

At the moment, however, the industry seems entrenched in free-market thinking and has so far countered efforts by US lawmakers to shine a light on how much drug development really costs. While secrecy of this type may benefit industry, at least in the short term, this is simply not in the public interest.

Until we know more about the actual cost of drug development, we are in no position to meaningfully critique the corporate model promulgated by the pharmaceutical industry, the drug costs put before regulators, or the claims of groups such as Tufts. Ultimately, that leaves health systems at the mercy of industry.

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.
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