07 July 2012

ICC and Down Syndrome

New Zealand advocacy group Saving Downs is reported to have persuaded the International Criminal Court (ICC) to conduct a preliminary examination in response to the group's claim that the New Zealand government’s prenatal screening programs (which include identification of Down Syndrome) amounts to genocide. The group is associated with Right To Life NZ.

It is important to read the group's promotional material critically, as there is no indication that the ICC has endorsed the group's claims regarding 'genocide', 'ethnic cleaning', 'social engineering' and 'selective breeding'. A preliminary investigation simply means that someone in the ICC prosecutor's office has received the group's paperwork and is looking at it prior to deciding whether the basis of the complaint against the NZ government is reasonable in relation to the ICC's charter.

The group has previously been unsuccessful in action within New Zealand, having argued that the availability of screening violates Article 2 of the United Nations Convention on the Prevention and Punishment of the Crime of Genocide because it imposes measures intended to prevent births within a 'specific human group'. Saving Downs characterises people with Down syndrome as both an ethnic group and a racial group on the basis that they are a stable and permanent group of people, linked genetically through having a third 21st chromosome, and share the same physical characteristics. From its perspective screening discriminates against people with Down syndrome and likewise supposedly violates the Crimes Act 1961 (NZ).

Article 2 of the Convention defines genocide as any act committed with intent to destroy - in whole or in part - a national, ethnic, racial or religious group. That act might include the imposition of measures intended to prevent births within the group. Article 6 of the Rome Statute of the International Criminal Court refers to “imposing measures intended to prevent births within the group'. The Statute - discussed in Building the International Criminal Court (Cambridge University Press, 2008) by Benjamin Schiff, The Emerging Practice of the International Criminal Court ( Martinus Nijhoff, 2009) by Carsten Stahn and An Introduction to the International Criminal Court (Cambridge: Cambridge University Press 2004) by William Schabas - gives the ICC the power to investigate and prosecute international crimes of genocide, crimes against humanity, war crimes, and crimes of aggression. Importantly the Statute refers only to groups of religious, ethnic, racial, and national classification.

It is unlikely that the ICC will conceptualise people with Down Syndrome as representing a group under the Statute. That means it will not go on to address the New Zealand screening program as genocide. The NZ Government has in the past argued that it is not mandating abortion on the basis of prenatal screening or euthanasia of minors. It has also recurrently indicated that screening is not compulsory and has been available in some form in New Zealand since 1968.

The New Zealand Human Rights Commission (HRC) reportedly determined that people with Down syndrome are not protected under Article 6 of the Statute and that screening as such is not in breach of the Human Rights Act 1993 (NZ). In subsequent consideration by the New Zealand Director of Human Rights Proceedings it was also reportedly determined that people with Down syndrome are not a discrete group protected under Article 6. The Director was approached by Right to Life NZ for representation in group proceedings before the NZ Human Rights Review Tribunal under s 80(4) of the Human Rights Act 1993 (NZ) on the grounds that the screening programme violated the Convention and the 1961 Crimes Act.

His determination was apparently provided in confidence to those who had sought his support and there is no clear information on the HRC/Director's site.

Claims that deaf people represent a discrete 'ethnicity' have similarly not gained traction in international law. Given its charter the ICC has not aspired to address all human rights abuses (and does not have the authority or resources to do so). It has not for example investigated offences against women and ethno-religious minorities in Saudi Arabia or China.

Given the attention received by claims of genocide it is perhaps unsurprising that advocates have used that characterisation in complaints to the Court. One example is the bizarre complaint that Zachie Achmat and Treatment Action Campaign (TAC) was guilty of genocide in South Africa for promoting cheap access to AZT and other anti-retrovirals, a matter discussed in works such as Jonathan Wolff's The Human Right To Health (Norton, 2012) and Ben Goldacre's Bad Science.

Trams

It's interesting to watch responses to the Victorian student-led initiative for 'tramsurance', promoted as letting "you fare protest worry free".

It appears that the idea was that people who were worried about penalties for evading fares on Melbourne public transport - particularly those lovely trams - would be able to contribute money ($19 per month) to an 'insurance' scheme, which would pay the fine for evaders who were caught by fare inspectors under the Transport (Compliance and Miscellaneous) Act 1983 (Vic).

One enthusiast claimed that "It's cheaper than buying tickets and has attracted around 1000 members since launching a couple of weeks ago". A proponent characterised the scheme as a fighting fund rather than insurance, with the comment "We will pay out all fines up to the limits of Tramsurance's income. Everyone has basically put money into a pool and then people claim their money out of it" and that "“We’re considering $19 per month. (But) to compare that, it’s $120 a month if you’re buying [the standard monthly ticket]”.

The state public transport authority (Public Transport Victoria) was unimpressed, arguing that the scheme was illegal because it incited consumers to break the law and that there were questions about whether the scheme could be made to work (eg would contributions be safeguarded and what would happen if the detection of a few evaders absorbed all of the contributions?).

There are arguably better ways to express discontent with ticket prices or the management of the public transport system than what seems to have initially promoted as an insurance scheme. One reason is that insurance in favour of an illegal act is in itself unviable. Australian law does not for example endorse insurance against loss of illegal drugs, failure of an assassination or an unsuccessful bank robbery. As a corollary it does not welcome insurance against imprisonment or fines imposed for criminal behaviour, eg if you are convicted for burglary you get to cash in at your insurer's expense.

Another reason is that the operation of insurance schemes and financial services schemes involves compliance with national law, notably the Insurance Act 1983 (Cth). It is highly unlikely that APRA, the national regulator, is going to be enthusiastic about a scheme that centres on illegality and would be persuasively claimed by the Victorian Government as contrary to the public interest. There is no indication that the students have the expertise required for compliance with regulatory requirements for offering an 'insurance product' or more fundamentally that they would satisfy the capital requirements regarding insurance. The likelihood of gaining a licence under the Financial Services Reform Act 2001 (Cth) for Tramsurance as a financial service is equally dim. The Dario Fo financial model, however well-meant and irrespective of whether it was promoted at an entrepreneurship event, simply won't fly.

Tramsurance initially put on a brave face after receiving a 'cease & desist' letter from Public Transport Victoria. It stated that -
we're coming against some very strongly worded letters. Never fear - it'll take more than words to stop us. There is too much momentum and support behind us now. All we have at this stage is an idea, an idea that has become very popular very quickly for one reason. The Melbourne public is dissatisfied with with how public transport and Myki have been handled. Public Transport Victoria is threatening to litigate against us rather than address the concerns of those it represents.
We will not take down the site. That would be a little silly given that we haven't operated anything yet. Tramsurance started off as a simple experiment, but we can all agree that it's much more than that now. We are currently seeking legal advice to better understand the options open to us. Rest assured, the final version of Tramsurance will operate fully within the law. We will announce our decision tomorrow, when we are better informed. In the meantime, please don't fare evade. That's against the law.
The organisers subsequently released an Open Letter that states
Tramsurance started only as an idea. Most people I know evade the fares every now and then. Why? Some didn’t want to endorse a system that didn’t represent them, but most just couldn’t afford to. It’s cheaper for them to pay the occasional fine than to pay for the fares. I understood that mathematically at least, Tramsurance could exist.
It is not just an idea any more. We were not surprised at the support for Tramsurance, though we didn’t expect it to explode like it did. This indicates how poorly the transport system has served its users. There would be no demand for Tramsurance if we were satisfied with the public transport in Melbourne. Demand has, of course, been explosive.
To address Public Transport Victoria’s statement we’ve publicized, we have no intention of breaking the law. Nor have we ever. We do not advocate fare evasion, even of a system whose fares are unaffordable to the more vulnerable members of society. It’s against the law. Don’t do it. We’ve outlined with our idea a simple possibility, and with that the failure of our government to meet the needs of its people.
Public Transport Victoria claims we are encouraging fare evasion. We have said we do not, repeatedly. Whether the proposed fund would encourage it is moot, but all we have is the proposal. We have not facilitated any transactions or written any code to do so. We don’t plan to either. Tramsurance is an idea that has simply illustrated the failings of our public transport system. It’s reprehensible that the government would rather threaten two 19 year olds than address the concerns of those it is supposed to represent.
In May this year the PTV announced [PDF] that there had been a 16% increase in the number of tickets being checked, with 154,000 fines for ticketing offences (up 47% on the previous year) - "no longer a case of if you get caught, but rather when” - and "a substantial decrease in the tram fare evasion rate, down from 20.3 per cent in May 2011 to 13.3 per cent in May 2012".

Paste

'My name is Paste. Copy Paste' in the 3 July Economist reports on another incident of academic plagiarism involving senior EU politicians -
According to party loyalists, Prime Minister Victor Ponta is in select company. Interior minister Ioan Rus on Friday claimed that "ever since Plato and Aristoteles, everyone who has ever written a PhD in philosophy, in social sciences, has plagiarised." Apart from the bemusement that Mr Rus's statement may cause, it is also an indication that despite energetic (foes say clumsy) attempts to silence the plagiarism scandal, the 39-year-old Prime Minister may be heading for the same political graveyard that contains the corpses of the German defence minister Theodor zu Guttenberg and the president of neighbouring Hungary, Pál Schmitt.
In an interview  with El Pais last week, Mr Ponta promised to resign if proven that his PhD about the International Criminal Court was an act of plagiarism. He made those statements before the ethics committee in charge gave its ruling, with its chairman saying it was plagiarised "copy-paste style", 85 pages out of a total of 307, from the work of another Romanian scholar.

Slippery

Breach of the Crimes Act? The SMH reports that Peter Slipper - the deliciously retro sometime Speaker in the Australian House of Representatives - wants to refer former aide James Ashby to the Australian Federal Police -
for investigation into whether he committed a criminal offence when he sent copies of the Speaker's diary to a former Howard government minister, Mal Brough, and the News Ltd journalist Steve Lewis. 
In a letter to Mr Ashby, Mr Slipper's lawyers suggested the former media adviser could have breached sections of the Commonwealth Crimes Act, which prohibits public servants from publishing or communicating internal documents without authorisation. The offence carries a maximum two years' jail. 
The letter, written on June 28, also suggests Mr Ashby could be prosecuted for participating in a conspiracy with Mr Brough, Lewis, and another Slipper aide, Karen Doane. Further, he may have committed the offence of causing harm to a public official under the Commonwealth Criminal Code. That offence carries a maximum 10 years' jail.
Ashby is suing Slipper and the Commonwealth, with claims that Slipper made unwelcome advances and sent him sexually suggestive text messages. Slipper and the Commonwealth allege the litigation is intended to ''vilify'' Slipper and ''destroy or seriously damage'' his reputation. They are seeking an order that proceedings be stopped as an abuse of process.

Ashby in response has referred to a right to claim a privilege against self-incrimination, given that he has been accused of serious criminal offences. The Commonwealth and Slipper argue Ashby should be forced to at least address the areas that did not raise a risk of self-incrimination.

Rares J has reportedly agreed that Ashby could not be forced to incriminate himself and excused him from putting on any evidence or revealing his defence until the case against him had been presented in full.

In the UK the Supreme Court in Phillips (Respondent) v Mulcaire (Appellant) [2012] UKSC 28 [PDF] has considered confidentiality, intellectual property and the privilege against self-incrimination.

The appellant Glenn Mulcaire had pleaded guilty in 2007 to offences regarding unauthorised access to voicemail messages (notably that of members of the royal household) as part of what's now often dubbed the News of the World phone hacking affair, discussed in Dial M for Murdoch (London: Allen Lane 2012) by Tom Watson &Martin Hickman. Mulcaire and News subsequently faced civil claims by individuals who alleged that messages on their mobile phones had been unlawfully intercepted. Respondent Nicola Phillips, in proceedings against News regarding messages left by clients on her mobile, argued that the messages on her mobile included
factual information, some of which is private information and some of which is commercially confidential information, including that relating to her clients’ personal lives and relationships, health, finances, incidents in which the police have become involved, personal security or publicity issues, commercial business transactions, professional relationships and future career plans
Phillips later applied to add Mulcaire as a defendant and for an order that he disclose the identity of the person instructing him to intercept the messages. Mulcaire opposed the order for disclosure arguiing that he could not be required to disclose that information as to do so would tend to expose him to prosecution. Phillips contested that argument, relying on the Senior Courts Act 1981 s 72 for excluding the privilege. That section applies to, among others, proceedings for infringement of rights pertaining to any intellectual property and, when it applies, it excludes the privilege if the offence to which the person would tend to be exposed is a related offence. The High Court and Court of Appeal held that Mulcaire could not rely on the privilege as both of those conditions were made out. Mulcaire was accordingly ordered to provide the requested information.

On appeal the Supreme Court considered whether -
  • information left in voicemail messages on Ms Phillips’s mobile is “technical or commercial information” within the definition of “intellectual property” such that the proceedings are “for infringement of rights pertaining to any intellectual property”; and 
  • on the footing that Mr Mulcaire would expose himself to a charge of conspiracy in providing the information ordered, such proceedings would be for a “related offence” within the meaning of s.72(5)
The Court's explanation of the leading judgment indicates that
the definition in s.72(5) contains the words “technical or commercial information”. The meaning of those words must be something in which a civil claimant has rights capable of being infringed. The fact that technical and commercial information ought not, strictly speaking, to be described as property cannot prevail over the clear statutory language. Whether or not confidential information can only loosely, or metaphorically, be described as property is simply irrelevant. Not all technical or commercial information is confidential. Conversely a secret about a person’s private life is not naturally described in normal usage as technical or commercial, even if it could be turned to financial advantage by disclosing it, in breach of confidence, to the media. Purely personal information is not “other intellectual property” within the meaning of s.72(5). The purpose of s.72 was to prevent remedies against commercial piracy from being frustrated, not to cover the whole of the law of confidence. While there may be commercial value in personal information and this may lead to some difficult borderline cases, it is not a reason for adopting an unnatural construction of the definition. On the facts pleaded in this appeal there is no great difficulty as to “mixed messages”, where some of the information is commercial and some is not. Ms Phillips’s pleading is to the effect that the voicemail messages left by her clients contained commercially confidential information. There is no reason to suppose that the commercial information was not significant. 
There must be a sufficient connection between the subject-matter of the claimant’s civil proceedings and the offence with which the defendant has a reasonable apprehension of being charged. Pursuant to s.72(5) the offence must be committed by or in the course of the infringement to which the proceedings relate unless the offence involves fraud or dishonesty, in which case a looser connection is sufficient. It is well established that conspiracy is a continuing offence. While the offence is committed as soon as the unlawful agreement is made, the conspiracy continues until the point when the agreement is terminated by completion, abandonment or frustration. If Mr Mulcaire conspired to intercept messages on mobile phones, an offence was committed when the unlawful agreement was made. But the offence continued so long as the agreement was being performed. Every interception pursuant to the unlawful agreement would be in the course of the offence.

04 July 2012

Lawfare

'Lawfare, Wikileaks, and the Rule of Law' by Eric Engle argues that
 "Lawfare" is the idea that international law only exists as a strategem; that states only comply with or create international rules as part of their quest for power; that power, not law or morality or even trade dominates international relations; and that states are rational power maximizers. As such, it is a variant within the (failed) IR Realist theory of international law.
This article outlines the tenets of "lawfare" placing "lawfare" in the broader historical context. It then places lawfare into the practical contemporary context. It positions lawfare within a spectrum of ideas and movements opposing globalization such as Wikileaks, Al Qaeda, Occupy Wallstreet, and also Neoconservatism. The article concludes that global liberalism ("Empire") will likely meet and triumph over each of these challenges because liberalism is open textured, sustainable, and self-replicating whereas its opponents are conspiratorial, fragmented, disorganized, lack a mass base, and cannot articulate a comprehensive and compelling alternative vision. ...
I wish to look at Wikileaks as an example of Foucault's theory of knowledge-as-power applied in practice to a network. Network theory argues that networks are more powerful (dominant) than isolated autarchic actors due to productive synergies and improved communications allowing more effective rationalizations and uses of power. The ideal power relationship, according to network theory, is a constantly growing and ever linked network: many nodes, with many linkages, and the number of nodes and linkages growing. Drawing from network theory, Assange/Wikileaks decided to try a disruptive strategy intended to render a network of international relations militarists inoperative. Notice however, that we can really only understand wikileaks as an instance of altruism, of enlightened self interest. The "payoff" for Assange/wikileaks, other than peer-recognition and whatever that entails (hot chicks, wild parties?) is decidedly not monetary. Wikileaks versus (U.S.) Empire is, like Al Qaeda versus (U.S.) Empire, a struggle between competing networks. Each seeks to disrupt the others' nodes and the linkages between the opponent's nodes. Low intensity conflict seems to be the present and future face of war, as exemplified in terrorist attacks and information warfare. Are the Chinese and Leo Strauss right? Is there no justice? To answer that, we must return to Aristotle.
Engle concludes - more poetically than (for me) persuasively -
The struggles, some overt, some covert, between Al Qaeda, Empire, Wikileaks, Chinese Maoists, and other international movements such as OWS swirl about us, dancing in the shadows. Sometimes, they strike fast and furious, like hell-fire, leaving a trail of tears and blood in their wake. To decipher these secret wars we must thread our way through the web of war, the maze of the minotaur man-beast, following Ariane's golden wisdom. We are in darkness. We seem lost. Yet, there is an exit. It is illuminated by the lamp of knowledge, a magic lantern: the knowledge of the rule of law as the means to justice to attain the good life of peace and prosperity for all. Will our fellow travelers take heed? I cannot say. There is an exit. Follow me. I know the way.

03 July 2012

Pharma Fraud

What were they thinking? In reading the overnight announcement about the US$3bn settlement by GlaxoSmithKline (GSK) with the US Government I'm struck by several passages in the Department of Justice media release -
The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18. The United States further alleges that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended. 
There's nothing like the old ghost-written journal article, an international practice highlighted here, here, here, here, here, here and the 2010 Grassley report [PDF].

Grassley noted that -
Medical ghostwriting is a practice where pharmaceutical or device companies hire medical education, marketing or communications companies to draft articles that are presented to prominent physicians and scientists to sign on as authors to increase the likelihood that the article will be published in important medical journals. Ghostwritten articles include articles that are drafted by pharmaceutical or device company employees who are not acknowledged in the final publication. The articles may be review articles, editorials or primary research papers, and they are typically presented to physicians and scientists affiliated with academic institutions. The physicians and scientists agree to sign on even if they may not be intimately familiar with the underlying data or relevant research or provided limited input on the article. Authors who make little to no contribution to a publication are also referred to as “guest” authors. 
Senator Grassley is concerned about the lack of transparency that exists in medical ghostwriting. Not only are the articles typically initiated and paid for by a pharmaceutical or device company, but also more significantly, the final publications do not disclose the company’s role and financial support for the article. Ghostwritten articles can have a significant impact on, among other things, physician prescribing practices. When prominent physicians and scientists lend their names to an article, it raises the credibility of the findings and conclusions presented. This, in turn, can affect the pocketbook of the American taxpayer since Medicare and Medicaid pay billions of dollars for prescription drugs. In addition, manipulation of medical literature could lead physicians to prescribe drugs that are more costly or may even harm patients.
A prominent researcher and professor of medicine at a leading medical school informed Committee staff that in the late 1990s and early 2000s it was common practice for pharmaceutical companies to approach him and his colleagues with requests to review and sign on as primary authors to company studies. Specifically, a company would tell a physician or scientist at an academic institution that it completed a study and would like his or her interpretation and feedback on the results of that study. In return, the company would offer that physician or scientist lead authorship on the paper, which was written by someone other than the physician or scientist. The physician or scientist would not be paid for being the author of the paper, but he or she may receive compensation for the time and effort related to reviewing and commenting on the study results. The researcher who contacted Senator Grassley stated that while he was aware of colleagues accepting the companies’ offers, his own policy is “I won’t touch it if I wasn’t involved in the concept of the study.”
The DOJ media release goes on to report that -
The United States contends that GSK paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wllbutrin for these unapproved uses. GSK has agreed to plead guilty to misbranding Wellbutrin in that its labeling did not bear adequate directions for these off-label uses. For the Paxil and Wellbutrin misbranding offenses, GSK has agreed to pay a criminal fine and forfeiture of $757,387,200.
 The DOJ notes that GSK
agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.
GSK supports the International Federation of Pharmaceutical Manufacturers & Associations 'global position' on misbehaviour, has its own corporate 'code of best practice' [PDF] and has vaunted [PDF] its ethical excellence.

Leftovers

Custodians of health data sometimes walk away from medical records and responsibilities, with a particularly egregious Australian example being the Dore clinic noted here.

The UK Information Commissioner (ICO) - counterpart of Australia's OAIC - has hit Belfast Health & Social Care (BHSC) Trust with a £225,000 Civil Monetary Penalty over a serious breach of the Data Protection Act. The Trust was responsible for the management of over 50 largely disused sites, including Belvoir Park Hospital. In March 2010 the Trust was alerted that trespassers had gained access to the Belvoir Park site, taken photos of patient records and posted them online.

That breach involved the sensitive personal data of thousands of patients, including notes, X-rays, scans and lab results. It also involved staff records such as unopened payslips. Media reports indicate that some records were offered for sale on the net. Others apparently featured in horror movie videos - in the style of The Blair Witch Project? - made by intruders who accessed the buildings and got to play around with medical records, used x-ray machines, lab equipment and other kit.

A superficial search of sites such as Flickr reveals a large number of snaps of the interiors of various buildings, medical equipment and piles of files. That's consistent with the vogue for 'asylum gothick' evident in for example Asylum: Inside the Closed World of State Mental Hospitals (MIT Press 2009) by Christopher Payne.

The Commissioner reports that the Trust -
carried out inspections of seven buildings at the hospital and a large quantity of patient and staff records were discovered, some dating back to the 1950s. However, some parts of the site were not inspected because they were either locked or inaccessible, due to concerns about asbestos contamination
While the Trust took action to improve the security of the site, including repairing damaged doors and windows, on 11 April 2011, the Irish News reported that it was still possible to access the site without authorisation. The Trust then increased the number of security guards on site and carried out a full inspection which revealed further records, many of which were being retained in breach of the Trust’s ‘Records Retention and Disposal’ policy. 
The Trust failed to report the situation at the Belvoir Park site to the ICO. The ICO’s investigation found that the Trust failed to keep the information secure and also to securely destroy medical documents which it no longer required.
The Commissioner comments that -
The Trust failed to take appropriate action to keep the information secure, leaving sensitive information at a hospital site that was clearly no longer fit for purpose. The people involved would also have suffered additional distress as a result of the posting of this data on the Internet. “The Trust has therefore failed significantly in its duty to its patients, and we hope that the action we’ve taken sets an example for all organisations that they must keep personal data secure, irrespective of where they choose to store it.
The  Commissioner has meanwhile imposed a £325,000 penalty on the Brighton & Sussex University Hospitals NHS Trust over exposure of "highly sensitive personal data belonging to tens of thousands of patients and staff" via Trust hard drives sold on an internet auction site in 2010.

The breach occurred when the Trust’s IT service provider was asked to destroy some 1000 hard drives held at Brighton General Hospital. A data recovery company bought four hard drives from a seller on the auction site.
Although the ICO was assured in our initial investigation following this discovery that only these four hard drives were affected, a university contacted us in April 2011 to advise that one of their students had purchased hard drives via an Internet auction site. An examination of the drives established that they contained data which belonged to the Trust. .... The Trust has been unable to explain how the individual removed at least 252 of the approximate 1000 hard drives they were supposed to destroy from the hospital during their five days on site.
The data included -
  •  details of patients’ medical conditions and treatment, disability living allowance forms and children’s reports. 
  • documents containing staff details including National Insurance numbers, home addresses, ward and hospital IDs, and information referring to criminal convictions and suspected offences.