Drug trials must not abuse peoples’ rights, European Bishops tell EU

Drugs trials necessary but must respect the vulnerable

Drugs trials are necessary before drugs come to market, but those conducting them have ethical duties to obtain consent and respect the rights of those from developing countries, says a statement on behalf of all Catholic Churches in the European Union.

COMECE, the Commission of the Bishops’ Conferences of the European Union, issued the statement through its Bioethics committee in response to the EU Proposal for “A Regulation on clinical trials on medicinal products for human use’ which aims at re-launching clinical research within the EU while at the same time ensuring protection to participants as well as the reliability of the acquired data. The European Commission proposed regulation which will be submitted to a vote of the European Parliament next 29 May

The statement on Ethical assessment of clinical trials on medicinal products: Respect and protection of vulnerable persons and populations  was released by COMECE this week in English and French.

Importance of consent

“Many people who are unable to give consent as well as people from less-developed countries often participate in clinical trials.” The COMECE statement asks how we can better protect them and vulnerable populations against abuse in the process.

The COMECE bioethics team conclude that  EU proposal could go further in the protection of the people concerned. A spokesperson said:

“The COMECE Secretariat welcomes this proposal for a Regulation as it goes in the right direction. The COMECE Reflection Group on Bioethics has monitored the issue from the launch of the public consultation by the European Commission and publishes today its Opinion on this proposal for a Regulation. ”

Key ethical concerns and principles

The COMECE team underlined some principles which they feel should be implemented in the proposed EU Regulation :

Volunteering

“The appreciation of the value of voluntary participation in research projects for the good of the community:  granting financial incentives to any person agreeing to take part in some medical research therefore raises ethical issues.”

Protecting those particularly vulnerable

“A key ethical consideration for research carried out on human subjects is that of respecting and protecting particularly vulnerable people and populations who could be unduly used as easily-exploitable objects for experiments.”

Benefits for the population concerned, especially in developing countries

“Clinical research with a disadvantaged or vulnerable population or community is justified only if it responds to its health needs and priorities and if it is likely that such a population or community will benefit from the results of the research.”

Security of the participants to tests

“The subject of research may agree to become involved in a research protocol that does not fully respond to the individual’s own interests but will do so for the good of others, in the “medical interest of the community” and consequently for the “common good”, insofar as the patient’s physical or psychological integrity is not endangered.” This underlines the importance of full and informed consent.

Benefits to the person incapable of consent

“Trial medicinal products should not be given to persons who are not capable of giving their consent except in cases where the same results cannot be obtained by resorting to persons capable of giving their consent and if the foreseeable benefits/predictable risks ratio is to their advantage.”

Ethics of testing in emergency situations

As for clinical trials in emergency situations, “the only acceptable research is specific research on individuals placed in such a situation that one may have good grounds for anticipating a direct benefit with regard to their condition and that would present a minimal risk and only impose a minimal burden. It is also important to give a sufficiently precise definition of the terms “minimal risk” and “minimal burden”. ”

The full statement on Ethical assessment of clinical trials on medicinal products: Respect and protection of vulnerable persons and populations is available in English and French

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Vatican supports new direction on health for World Health Organization

This week has seen several interventions by the Vatican delegation to the World Health Organization’s key decision making body.

The Sixty-sixth World Health Assembly , which is the  decision-making body of the World Health Organization , and in turn the  public health body of the United Nations was taking place this week in Geneva.

Catholic support for improving population health

Archbishop Zygmunt Zimowski,  head of the Holy See’s delegation, in a brief but wide-ranging speech

  • called on WHO to affirm the centrality of spiritual needs to any approach to universal health care
  • supported the WHO’s aims to prevent non-communicable diseases such as Heart Disease and Cancer
  • affirmed the need to control and prevent disease in older people
  • supported WHO intentions to further reduce preventable deaths especially in women and children but differed on emergency contraception from WHO’s suggested stance
  • reminded the WHO of the significance of the Catholic Church’s health care agencies and infrastructure (up to 25% of HIV care worldwide, over 50% of health care in some countries)

Archishop Zimowski’s intervention is covered in more detail on Catholics in Healthcare blog.

Responding to WHO General Secretary on health of women and children

Dr Margaret Chan, Director General, outlined her goals for her time as Director General as including  “the health of women and of the people of Africa.” Archbishop Silvo Tomasi, the Holy See’s Permanent Observer to the United Nations and part of the Holy See’s delegation at the Assembly expressed his support for these objectives, and went on to explain the Catholic Church’s global and local experience in those areas.

Health of the people of Africa

The Archbishop went on to offer the experience of the Church in support of Dr Chan’s goal for improving the health of the people of Africa. “[M]any nations are still in the grip of famine, war, racial and tribal tensions, political instability and the violation of human rights.” Pope Benedict XVI’s exhortation to the international community is also very appropriate, “we must not forget Africa ….”

Emphasising the care of the whole person

Tomasi finalised his intervention with a vision of health that reminded the WHO of it’s own aspirational definition of health. We should seek a deeper care for every aspect of the human person.

“My delegation urges a perspective on health security that is grounded on an anthropology respectful of the human person in his or her integrity and looks far beyond the absence of disease to the full harmony and sound balance of the physical, emotional, spiritual and social forces within the human person.”

In recent years the Vatican has moved to emphasise not only its stance on reproductive health at WHO events but has taken on a stronger public health focus. This latest WHO Assembly has seen Vatican interventions aimed at sharing the wider health and social justice concerns of the Church.

World Health Organization told spiritual needs “integral” to universal health care

The Sixty-sixth World Health Assembly was told this week that any integral approach to universal health care coverage must include addressing the spiritual needs of populations.

The Assembly is the decision-making body of the World Health Organization , the health and public health body of the United Nations and has universal health care coverage as one of its key strategic aims.

In a wide-ranging intervention which also signalled strong Vatican support for universal health-care measures, Archbishop Zygmunt Zimowski, President of the Vatican’s Pontifical Council for Health Care Workers and head of the Holy See’s delegation to the World Health Assembly said that any “integral” approach to healthcare need must focus on “the spiritual state of the person” and not just medical interventions or economic growth.

“Health and development ought to be integral if they are to respond fully to the needs of every human person. What we hold important is the human person – each person, each group of people, and humanity as a whole.”

The archbishop said that health care contributes to the development of nations “and benefits from it.” The Holy See “strongly believes” that universal health care coverage as a goal of government policy is a more certain way to achieve “the wide range of health concerns,” including preserving present advances.

The archbishop said that health care contributes to the development of nations “and benefits from it.” The Holy See “strongly believes” that universal health care coverage as a goal of government policy is a more certain way to achieve “the wide range of health concerns,” including preserving present advances.

Archbishop Zimowski then turned to efforts to save the lives of millions of people who die each year “from conditions that can easily be prevented.” He praised a resolution before the assembly to improve the quality, supply and use of 13 “life-saving commodities.”

“The Holy See strongly agrees with the need to achieve further reductions in the loss of life and prevention of illness through increased access to inexpensive interventions that are respectful of the life and dignity of all mothers and children at all stages of life, from conception to natural death,” he said.

However, he voiced “serious concerns” about the assembly’s secretariat report and its executive board-recommended resolution that includes “emergency contraception.” He said some of these drugs have an abortifacient effect.

“For my delegation, it is totally unacceptable to refer to a medical product that constitutes a direct attack on the life of the child in utero as a ‘life-saving commodity’ and, much worse, to encourage ‘increasing use of such substances in all parts of the world’,” he said.

The archbishop welcomed the assembly’s proposed global action plan to control non-communicable diseases. He said his delegation was “especially pleased” that the plan recognizes the “key role” of civil society institutions including faith-based organizations in encouraging the prevention and treatment of these diseases.

“Our delegation is aware that Catholic Church-inspired organizations and institutions throughout the world already have committed themselves to pursue such actions at global, regional, and local community levels,” he said.

Archbishop Zimowski also voiced interest in aspects of preventing and controlling diseases in older age, noting faith-based institutions’ long tradition of care for the aged and the rapid growth of the elderly population. He noted that the Vatican will host an international conference Nov. 21-23 about caring for the elderly with neurodegenerative diseases.

 

Happiness, Happiness….a practical take on psychology and wellbeing

Jim McManus

Jim McManus is a Chartered Psychologist, Chartered Scientist and Associate Fellow of the British Psychological Society. He is Editor of Catholics in Healthcare blog

Happiness has been a concern of psychology and public policy since Seligman’s work at least, and the development of new orientations in psychology studying not human problems, but human thriving is just one of the remarkable signs that psychology as a field of science is flourishing. It’s an exciting time to be a psychologist as we see applications of psychology range from long term illness to organizational innovation, child development and human happiness.

The field of psychology has recently seen the emergence of sub-fields like Community Psychology, Positive Psychology and other specialisms, working on human strengths and human flourishing…so seeking strengthen, not problematize, ordinary lives.

The advent of scientifically sound research on this has given impetus to policy developments at national and international level that what we need to do as health systems and communities is help people thrive. With this comes the well-researched insight that population mental wellbeing and resilience is important. This has seen expressions in the last few years (all with good evidence base) ranging from the 5 ways to wellbeing (New Economics Foundation) to the recent Government Strategy no health without mental health and the Royal College of Psychiatrists no health without public mental health.

Doing this practically can often seem to be easier said than done, but there have been a number of practical initiatives run in local areas seeking to put these concepts into practice. Positive Psychology is taking off, and the accredited mental health first aid movement is just one example of how people can turn these insights into a series of programmes. Catholics have a series of demonstration projects and initiatives on mental health, wellbeing and dementia in the Catholic Mental Health Project

But now comes a timely and sensible intervention for faith communities. John Bingham, writing in the news and religion section of today’s Daily Telegraph, tells the story of how Livability, the disability charity with a Christian ethos, is busy rolling out a “happiness” course in parishes and churches across the Country.

Bingham’s piece says “The so-called “Happiness Course” combines basic principles of secular popular psychology with ideas such as forgiveness and gratitude, promoted for centuries by Christianity. It is based on the principle that applying simple Biblical ideas such as “counting your blessings” or forgiving enemies could actively improve people’s psychological well-being.”

In fact, this is not secular popular psychology. This course has links to well researched psychological insight. What is different about positive psychology and the psychology of happiness is that there has been a significant impetus to popularize it while, for the most part, keeping faith with the underlying science.

Positive Psychology,  some of whose  insights the Livability course seems to derive from, is defined by the  Positive Psychology Center at the prestigious University of Pennsylvania as “the  scientific study of the strengths and virtues that enable individuals and communities to thrive. The field is founded on the belief that people want to lead meaningful and fulfilling lives, to cultivate what is best within themselves, and to enhance their experiences of love, work, and play.”

The interesting thing is that Livability are synthesising faith concepts about what makes a healthy and happy life with sound scientific psychology, and finding not only that there is no conflict but that they work well together.

This too has a practical value well-grounded in research. Studies of organizational culture and take-up of health messages show that when people can relate scientifically sound messages to their own belief systems, there is more likelihood the messages will be seen to be salient and the messages will not only be taken up but sustained.

The Livability course is a neat innovation in the field of practical or pastoral theology, and an equally neat innovation in the field of public mental health.

We need to see more of this.

Some useful links

http://www.livability.org.uk/

http://www.ppc.sas.upenn.edu/

http://www.telegraph.co.uk/news/religion/10064228/Archbishops-daughter-spearheads-drive-to-teach-happiness-in-churches.html

http://www.mentalhealthproject.co.uk/

http://positivepsychology.org.uk/

Iraqi Christians

Martyrdom
The Dominicans are posting a series of three interviews with Fr. Nageeb Michael, OP. The second video focuses on the current suffering of Iraqi Christians. Fr. Nageeb speaks at length about the current persecution of the Christian community in his homeland and even introduces his viewers to priests he knows personally who were martyred for the faith. The interview concludes with a plea for solidarity with and prayers for the Christian community of Iraq.
For more on Fr. Nageeb’s work, visit: http://www.hmml.org/preservation10/Iraq.htm
To learn more about the Dominican Friars, visit: http://www.dominicanfriars.org
This video produced by: http://www.DominicanaBlog.com

Anscombe Bioethics Conference on “a giant among women philosophers”

The Moral Philosophy of  Dr Elizabeth Anscombe

On 27th and 28th September 2013 the Anscombe Bioethics Centre will host a major international conference on the moral philosophy of Elizabeth Anscombe, after whom the Centre is named.

Gertrude Elizabeth Margaret Anscombe has been described as ‘a giant among women philosophers’, as ‘the greatest English philosopher of her generation’ and as one of the ‘pioneers of a genuine renewal of Catholic thought’. She was ‘a titan in the world of philosophy’ who was ‘widely recognised as one of the greatest philosophers of the twentieth century’.

The venue will be St Hugh’s College, Oxford (where Dr Anscombe was an undergraduate student).  The price is £140 for ‘early bird’ conference registration, light refreshments and lunch only for the two conference days (without accommodation). Concessions £70. For details please see the booking pages.

Participants, who are all bioethicists and moral philosophers of international standing, will include:
Christopher Coope,
Rev Prof Kevin Flannery SJ
Dr Mary Geach,
Rev David Goodill OP
Prof Luke Gormally,
Dr Edward Harcourt,
Dr David Albert Jones,
Prof Anselm Müller (Anscombe Memorial Lecturer 2013),
Dr Matthew O’Brien,
Prof Thomas Pink,
Prof Duncan Richter,
Dr Roger Teichmann,
Prof Jose Maria Torralba and
Prof Candace Vogler.

For more information, programme and to register visit here

http://bioethics.org.uk/detail/news_and_events/g_e_m_anscombe_s_moral_philosophy_conference

To read more about Elizabeth Anscombe read here

http://www.bioethics.org.uk/page/about_us/about_elizabeth_anscombe

National Secular Society takes exception to NHS funded chaplains – again

 

Terry Sanderson, writing in a blog piece It’s the Church’s Christian duty to support the health service, not leech off it for the National Secular Society, takes exception to Archbishop Vincent Nichols and to NHS funding of chaplains. Again.

Archbishop Nichols, says that hospital chaplaincy services   ought never to be seen as a luxury to be discarded when budgets are tight; or chapels as spaces to be sacrificed to other purposes when needs arise. People need spaces where they can come to pray for their sick relatives and friends. Those who are sick need places to pray, to receive the consoling touch of the divine. Healthcare professionals need somewhere to pray as part of their care for their sick brothers and sisters, as well as to receive strength for their ministry.”

Mr Sanderson feels that religious groups in advocating for the Chaplaincy services the NHS provides, ignore the current NHS financial situation. Medics, not chaplains, make you better he says.