Category: Medical


Freedom of information and unpublished data from a randomised controlled trial on ME/CFS

12 June 2013 by David Hart QC

zCCQueen Mary University of London v the Information Commissioner (1) and Robert Courtney (2) First Tier Tribunal EA/2012/0229 read judgment

Rosalind English has recently posted here on incomplete academic work in the climate change field. This appeal is closely related, in that it concerns a university’s claim to hold on to data from a publicly-funded randomised controlled trial pending peer-reviewed publication.

Between 2005 and 2010 Queen Mary ran a trial into the efficacy and safety of the current treatments for Chronic Fatigue Syndrome/Myalgic Encephalopathy, namely Adaptive Pacing Therapy , Cognitive Behaviour Therapy and Graded Exercise Therapy. £5m of public money was spent, and the perceived benefits (and some of the detriments) were written up into a major article published in the Lancet in March 2011. The upshot, said this article, was that CBT and GET could be safely added to current medical care with a moderate improvement in outcomes. This recommendation has already fed into an interim review of the NICE guidelines on CFS/ME.

However, the data on deterioration within the trial had not been fully published. You could not see how many patients deteriorated in response to each therapy, just the net deterioration over the whole cohort. Our appellant, Mr Courtney, is evidently a bit sceptical about the results of this trial. As he pointed out, the deterioration data had a 20 point difference, whereas the improvement had only to be modest – an 8 point difference. And, he said, how can patients sensibly form a view on treatment without knowing how much deterioration that specific treatment might cause?

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Can an employer increase the sanction for misconduct on appeal?

11 June 2013 by Martin Downs

pdp0564782_97This was the question confronting Judge Hegarty QC in, McMillan v Airedale NHS Foundation Trust [2013] EWHC 1504 QB – read judgment

The answer of the Court was that clear and express words in the contract would be required in order to confer a power to increase a sanction on an Appeal Panel.

The Claimant was a Consultant Obstetrician and Gynaecologist who was involved in a serious untoward incident when a patient suffered significant and uncontrolled bleeding in the aftermath of a successful caesarean delivery which necessitated emergency surgery to remove her spleen. In the aftermath, the Trust’s Medical Director formed the view that the Claimant had not been honest about the care of the patient and had, in fact, given conflicting accounts. This was also the conclusion of a disciplinary hearing which then issued a final written warning and referred the case to the GMC. The Claimant appealed.

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Comment | Abortion and conscientious objection: what about human rights? – Elizabeth Prochaska

22 May 2013 by Guest Contributor

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Doogan and Wood v. NHS Greater Glasgow & Clyde Health Board [2013] CSIH 36 – read judgment here and Alasdair Henderson’s commentary here

It is easy to become complacent about women’s reproductive rights in mainland Britain. Compared to our Irish neighbours, women here are able to access their chosen contraceptive, abortion and maternity services with relative ease. When Savita Halappanavar died after she was refused an abortion in Galway, commentators lamented a system where a woman could be told by healthcare staff that she couldn’t have an abortion because Ireland is a Catholic country. We imagined that such events could not happen here. A recent judgment of the Scottish Inner House of the Court of Session (the Scottish Court of Appeal) shakes that belief. Of most concern is that the court failed to engage with the human rights implications of its decision.

Our abortion law is found in the Abortion Act 1967. Section 1 makes abortion lawful only when it has been authorised by two doctors who attest that continuing the pregnancy poses a risk to a woman’s physical or mental health, or where the child would ‘suffer from such physical or mental abnormalities as to be seriously handicapped’. In effect, all abortions, save those for fetal abnormality, are performed on the basis that there is a threat to the woman’s physical or mental integrity as a result of pregnancy. Section 4 excuses a person from ‘participating in any treatment’ under the Act if they express a conscientious objection to abortion. As the Abortion Rights campaign points out, the law gives doctors control over women’s informed choices about their pregnancy that can lead to damaging delays in accessing abortion services.

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Closing the loophole: Care services and human rights protection – Sanchita Hosali and Helen Wildbore

22 May 2013 by Guest Contributor

Care homeMuch of the House of Lords debate surrounding yesterday’s Second Reading of the Care and Support Bill focused on seeking solutions to complex issues around the future provision of care. Additionally, as several peers flagged, the Bill also provides a timely opportunity to clarify which bodies have legal obligations to uphold protections under the Human Rights Act. Baroness Campbell noted “those who receive their care not from a public authority but from a private body lack the full protection of the Human Rights Act…[This] is a loophole that must be closed.”

What loophole?

Section 6 of the Human Rights Act essentially creates a legal duty to respect, protect and fulfil certain human rights (drawn from the European Convention on Human Rights). This duty is placed on public authorities and those performing “public functions”. The second type of body – those performing public functions – has proved somewhat awkward in practice, particularly in relation to those who receive care services.

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Assisted dying in Switzerland: Unclear lethal drug prescribing guidelines breached human rights

15 May 2013 by Isabel McArdle

Syringe-used-for-flu-vacc-007GROSS v. SWITZERLAND – 67810/10 – Chamber Judgment [2013] ECHR 429 – Read judgment / press summary

The European Court of Human Rights has ruled that Swiss guidelines for doctors prescribing lethal drugs were too unclear and therefore breached article 8 ECHR, the right to private and family life. Ms Gross sought a prescription for a lethal drug to end her own life. She has no critical illness, but is elderly and feels that her quality of life is so low that she would like to commit suicide. The Swiss medical authorities refused to provide her with the prescription.

Assisted dying and the right to die have been firmly back in the spotlight this week, with the cases of Lamb and “Martin” going to the English and Wales Court of Appeal. Mr Lamb is taking up the point made by Tony Nicklinson in the High Court, before his death, that doctors should have a defence of necessity to murder charges in cases of assisted suicide. Mr Nicklinson’s widow, Jane, is continuing his fight too. The cases also challenge the current guidelines on when prosecution should be brought for assisting suicide. You can read more about the background to the right to die caselaw here.

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Conscientious objection to abortion: Catholic midwives win appeal

3 May 2013 by Alasdair Henderson

human-foetus_1666004cDoogan and Wood v. NHS Greater Glasgow & Clyde Health Board [2013] CSIH 36 – read judgment here

The Inner House of the Court of Session (the Scottish civil court of appeal) ruled last week that two midwives from Glasgow could not be required to delegate to, supervise or support staff on their labour ward who were involved in abortions. 

The ruling makes it clear that the conscientious objection provision in s.4 of the Abortion Act 1967 has very broad scope. This probably means that the General Medical Council (GMC), the Nursing and Midwifery Council (NMC), the Royal College of Midwives (RCM) and the Royal College of Nursing (RCN) will all need to change their guidance on the subject, since the existing versions take a much narrower view. This judgment affects England and Wales as well as Scotland (since the Act covers all three countries), but not Northern Ireland.

The facts of the case, and the original decision of Lady Smith in the Outer House of the Court of Session are covered in our previous blog post here.

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Genetic testing of children up for adoption

27 April 2013 by Rosalind English

12280487228O6zG0Y and Z (Children), 25 April 2013 [2013] EWHC 953 (Fam) – read judgment

Having children is a lottery. No judge or court in the land would sanction the regulation of childbearing, however feckless  the parents, unsuitable the conditions for childrearing, or unpromising the genetic inheritance.

Adoption on the other hand is stringently regulated, set about with obstacles for prospective parents, and strictly scrutinised by an army of authorities backed up by specialist family courts and a battery of laws, statutory instruments and guidance papers. Usually the filtering is in one direction only: the suitability of the parents to the child or children up for adoption. But sometimes it goes the other way, and this case raises the fascinating and somewhat futuristic question of whether children’s chance of finding a suitable home might be increased by genetic testing.

The circumstances were somewhat exceptional here, since the local authority had ascertained from the biological father  of the two young boys in question that they might have a chance of inheriting a rare genetic disorder of the central nervous system. Huntington’s Chorea is caused by a single gene mutation on chromosome IV and causes damage of the nerve cells and areas of the brain which in due course leads to severe physical, mental and emotional deterioration. Anyone whose parent has the disease is born with a fifty per cent chance of inheriting the gene. Anyone who inherits the gene will, at some stage, develop the disease. 
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Doctor entitled to rely on GMC’s assurance that his Caribbean qualification would be acceptable in UK

18 April 2013 by Rosalind English

785px-Doctors_stethoscope_1Patel, R(on the application of) v The General Medical Council  [2013] EWCA Civ 327 – read judgment

Kate Beattie of 1 Crown Office Row was led by Richard Drabble QC for the appellant in this case. She has nothing to do with the writing of this post.

The registration criteria for doctors trained abroad have been changed to respond to abuse by medical schools claiming false affiliations with the institutions listed in the WHO Directory. Although the 2006 rules effecting this change were lawful,  the appellant had a legitimate expectation that he could rely on individual and specific assurances that he would be allowed to register on completion of his training.

The appellant, a qualified pharmacist, wished to qualify as a doctor. He sought assurances from the GMC that his part time course with a medical school in St Kitts. affiliated with the London College of Medicine, would lead to an acceptable qualification. The GMC’s replies indicated that it would be. He performed his pre-clinical studies by distance learning at IUHS in St. Kitts and then completed his supervised clinical rotations at United Kingdom hospitals. This course clearly represented a huge investment of time and money by the appellant.  However, registration of his Primary Medical Qualification (PMQ) was subsequently refused because the registration criteria had been changed.
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The Patentability of Human Genes: more developments

20 March 2013 by Rosalind English

Breast Cancer in DNA StrandsCancer Voices Australia v Myriad Inc 13 February 2013 – read judgment

Another battle in the war against gene patenting has been lost, this time in Australia.

The US litigation is still ongoing, with the US Court of Appeals for the Federal Circuit upholding Myriad’s patents on DNA sequenced in the laboratory: see my post on that judgment. On 30 November 2012, the US Supreme Court announced that it would hear an appeal in the Myriad case. The US law in relation to the patentability is therefore not likely to be settled until the Supreme Court reaches it own decision on the issue.

This Federal Court ruling in Australia has now endorsed the government’s rejection of calls for an outright ban on the patenting of genes  by ruling that  isolated nucleic acid (including isolated DNA and RNA) is patentable.  
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Fine tuning medical diagnoses to rare genetic disorders

9 March 2013 by Rosalind English

298x232-dna_genetic_test-298x232_dna_genetic_testMeiklejohn v St George’s Healthcare Trust [2013] EWHC 469 (QB) – read judgment

Richard Booth of 1 Crown Office Row acted for the claimant in this case. He is not the author of this post.

There is no doubt that medical diagnosis and therapy are struggling to keep pace with the genetic information pouring out of the laboratories and sequencing centres. And the issue of medical liability is being stretched on the rack between conventional treatment and the potential for personalised therapy. Treatment of disease often turns out to be different, depending on which gene mutation has triggered the disorder. However fine tuned the diagnosis, it may turn out to be profoundly wrong in the light of  subsequent discoveries.

This is perhaps an oversimplified characterisation of what happened in this case, but it exemplifies the difficulties facing clinicians and the courts where things go wrong, against the backdrop of this fast-moving field of scientific endeavour.
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Mid Staffs Inquiry report: Human rights abuses need human rights solutions – Sanchita Hosali

6 February 2013 by Guest Contributor

Stafford hospital report over deaths

This guest post is by Sanchita Hosali, Deputy Director at the British Institute of Human Rights. A number of 1 Crown Office Row barristers represented parties to the Inquiry, none of whom has contributed to this post.

Hundreds of people have died; others have been starved, dehydrated and left in appalling conditions of indignity, witnessed by their loved ones. Surely this is what Chris Grayling, Justice Secretary, had in mind when he recently cautioned to need to “concentrate on real human rights”?

Yet the rights, legal accountability, and practical benefits of the Human Rights Act are rarely mentioned in discussions about the shocking failures of care such as those featured in today’s Public Inquiry Report in events at Staffordshire Hospital between 2005-2008.

As Mr Francis makes clear, what happened at Staffordshire Hospital was a breach of basic rights to dignity and respect, and what is needed now are stronger lines of accountability and culture change which places patients at the heart of healthcare. Human rights speak to the fundamental standards that the Report says are needed to achieve this transformation in care.

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Mid Staffordshire Public Inquiry report published

6 February 2013 by Adam Wagner

Screen Shot 2013-02-06 at 11.37.46The Mid Staffordshire NHS Foundation Trust Public Inquiry report has been published. Robert Francis QC was tasked to investigate the role of the commissioning, supervisory and regulatory bodies in the monitoring of Mid Staffordshire Foundation NHS Trust. 

Read the report:

The report built on the work of Francis’s earlier independent inquiry into the care provided the hospital between January 2005 and March 2009. A number of 1 Crown Office Row barristers, including me, represented various participants at the Inquiry. They were:

  • Sally Smith QC and Christopher Mellor for the Strategic Health Authority;
  • David Hart QC for the CQC
  • Owain Thomas for the NHSLA;
  • Jeremy Hyam and Kate Beattie for a number of the families;
  • Shaheen Rahman and Peter Skelton for AVMA and the Patients Association;
  • Adam Wagner for the Department of Health.

Child radiotherapy case: “one cannot enjoy even diminished quality of life if one is not alive”.

19 January 2013 by Rosalind English

Sally+Roberts+arriving+at+the+High+CourtAn NHS Trust v SR [2012] EWHC 3842 (Fam) – read judgment

The highly publicised case about a seven year old boy whose estranged parents could not agree about the necessary treatment following surgery for his brain tumour was resolved by a firm ruling in favour of orthodox medicine by Bodey J, four days before Christmas.

The facts of the case are well known, but it may be instructive to lay out some of the details of the procedure that follows in a situation like this, and to point up the approach of the courts to a matter where orthodox science lies flat against the claims of complementary medicine. Where the life of a child is at stake, there is no polite equivocation between the two.

Background

Briefly, the mother would not agree to the recommended post-operative course of chemo- and radiotherapy (carrying an 80% chance of success), believing instead that her son would fare better with alternative forms of treatment and would avoid or reduce the undoubtedly detrimental long-term side effects of the treatment package being proposed. In a serious matter such as this, where the parents cannot agree, an application has to be made to the court for a declaration that the procedure in question is lawful. That involves a decision as to the child’s best interests, being the court’s paramount consideration. Hence it was incumbent on the NHS Trust concerned to apply to the High Court to determine the issue of N’s treatment following on from his brain surgery two months previously.
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From base pairs to the bedside: medical confidentiality in a changing world

12 December 2012 by Rosalind English

DNA database impact on human rightsThis week David Cameron announced plans  to introduce whole genome mapping for cancer patients and those with rare diseases within the NHS. 

Single gene testing is already available across the NHS ranging from diagnosing cancers to assessing patients’ risk of suffering side effects from treatment, but this initiative will mean that the UK will be the first country in the world to introduce the technology within a mainstream health system, with up to 100,000 patients over three to five years having their whole genome – their personal DNA code –sequenced. According to Chief Medical Officer Professor Dame Sally Davies

The genome profile will give doctors a new, advanced understanding of a patient’s genetic make-up, condition and treatment needs, ensuring they have access to the right drugs and personalised care far quicker than ever before.

What will this mean for medical confidentiality?  The official announcement ends with the following declaration:

1. Genome sequencing is entirely voluntary. Patients will be able to opt out of having their genome sequenced without affecting their NHS care.

2.  Whole genome sequence data will be completely anonymised apart from when it is used for an individuals own care.

3. A number of ways to store this data will be investigated. The privacy and confidentiality of NHS patients will be paramount in this decision.
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Should any genetic information be a trade secret?

3 December 2012 by Rosalind English

dna_infograph1I posted previously on the decision by the   US Court of Appeals for the Federal Circuit to uphold the patents on the genetics company Myriad’s gene sequences for breast cancer research and therapy. In September 2012 the American Civil Liberties Union once again petitioned for Supreme Court review.  The Court should decide today whether to review the case.

The whole question of proprietary claims over genetic information is not limited to patents and is very much open to debate.  In my piece on the US Bioethics Commission’s report to the Obama administration I discussed the challenge faced by lawmakers in regulating the increasing flow of genomic information so as to protect people’s privacy without shutting down the flow of data vital to biomedical research. Whilst it is true that the availability of patent protection creates vital incentives for such research, genetic testing companies like Myriad can extend their exclusivity beyond their patented products by creating limiting access to private databases containing information vital to interpreting the clinical significance of human genetic variations. There is concern that this threatens to impede the clinical interpretation of genomic medicine. The Genomics Law Report Journal reports that

National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing.
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