EHA Articles

Would you sell Peripheral Blood derived Stem Cells?

Thu, 01 Mar 2012 18:18:08 +0100

There are many things that are different in the United States of America (USA) and Europe. Some of these differences are in favour of society in the USA and some in Europe. We think there is one area where all European doctors and scientists agree and that is the altruism associated with donating blood, platelets, bone marrow and mobilised peripheral blood stem cells (PBSC). Altruism (a term coined in the 19^th century the philosopher Auguste Comte) is defined as a concern for others and a motivation to provide something of value to a party who must be anyone but one’s self. There must be no expectation of any compensation or benefits, either direct or indirect. Altruism also refers to an ethical doctrine that individuals are morally obliged to benefit others.

In Europe a group of like-minded physicians and scientists, led by Professor Bruno Speck from Switzerland, got together in 1973, calling itself the European Group for Bone Marrow Transplantation (EBMT). Their main focus was to encourage discussion among stem cell ‘transplanters’ about the clinical and scientific problems relating to stem cell transplantation and to collect and collate information from all European centres. These doctors and scientists never considered selling bone marrow or stem cells. They envisaged the donation of these products would always be altruistic. That attitude has persisted in Europe until the present.

We who are involved in human stem cell transplantation know perfectly well that stem cells from bone marrow or mobilized peripheral blood are essentially the same. The recent judgment in the U.S. Court of Appeals reminds us of the quotation by Charles Dickens (1812-70) in his novel Oliver Twist: ‘if the law supposes that’, said Mr Bumble…’the law is a ass – a idiot…and the worst I wish the law is that his eye may be opened by experience – experience’.

Yes, of course there are differences in the distribution of T lymphocytes and memory cells and there are subtle differences in engraftment kinetics and chronic Graft versus Host Disease incidence but the pluripotent cells in the inoculua are doing the same job, i.e. repopulating the recipient’s hemopoietic and immunologic systems. We also know that the statement ‘complications for the donor are exceedingly rare’...is not true. A number of deaths, associated with the procedure, have been reported in peripheral stem cell donors and surprisingly this seems to be a more frequent event than in bone marrow donors.

The European Hematology Association (EHA) has always believed that the donation of bone marrow, mobilized peripheral blood stem cells or stem cells derived from umbilical cord blood should be an altruistic act and the product should be available free of charge (excluding administrative costs which may include transport) to the recipient. While it is true that blood banks in some European countries offer a small token of thanks to blood and platelet donors the donation is still essentially an altruistic act.

The federal government, Cohen states, has an option to review the Flynn decision with the option of a ruling by the Supreme Court. We sincerely hope this is done in a timely fashion and that common sense prevails. Stem cells are stem cells and should not be sold in the market like a commodity such as oil!

Professor Shaun McCann, on behalf of the EHA Communication Committee

Cohen Glen I. Selling Bone Marrow – Flynn v. Holder. N ENGL J MED 2012; 366;4: 296-297
42 U.S.C. 274e (2006)

EHA supports the European Medicines Agency's investigation into risk based quality management of clinical trials

Mon, 20 Feb 2012 10:31:43 +0100

EHA has responded to the EMA’s call for comments on the reflection paper on February 15. In its response, EHA encourages the agency to continue to develop – along the lines described in the paper – a more systematic, prioritized, risk-based approach to quality management of clinical trials in support of the principles of Good Clinical Practice. However, EHA is keen to see that this development does not result in an increase of the administrative burden. Especially where academic trials are concerned, cost reductions and simplification are needed.
Related publications about EHA’s position on Clinical Trials: Revision of the Clinical Trials: No time to waste

Report "Haematology and the next European Decade"

Thu, 22 Dec 2011 10:01:13 +0100

Press Release: Better funding for research into blood diseases will save more lives

Wed, 09 Nov 2011 11:34:21 +0100

“Haematology is probably the area of medicine that has progressed the most in recent years”, said Professor Robin Foà of “La Sapienza” University of Rome. “For example, acute lymphoblastic leukaemia (ALL), the most frequent form of cancer in children, used to kill most children that had it. Before, we used to cure 20 to 30 percent of cases; these days, we cure 80 per cent of cases.” He added: “If we had more funding, we could definitely do more.”
This was one of the key messages on the first day of a two-day conference, “Haematology and the next European decade”, hosted by the European Parliament to highlight the positive impact of haematology research across a range of medical conditions, and the leading role it will have in the knowledge economy envisaged in the European Union’s 2020 Strategy.

Today the conference – attended by doctors, researchers, parliamentarians, patients’ organisations and Commission officials – also discussed the European Commission’s Green Paper on the Common Strategic Framework for the funding of research and innovation, which will affect how much of the €80 billion allocated in the next EU budget to all areas of research will go towards health.

Haematology – a discipline covering all blood-related areas, from frequent diseases like anaemia to rare cancers, including malignant and non-malignant diseases – is always at the forefront of medical research, both at its basic level and its application, which these days often involves working closely with the biotechnology industries.

It is literally vital for patients that any new EU legislation should improve co-operation for more and better-targeted funding for research in haematology, allowing haematologists to secure the research resources they need to help patients access the best possible expertise and treatment. The conference therefore aims to create grass-roots momentum for collaboration by all stake-holders at European, national and regional level to ensure this happens.

This is why initiatives like the Brussels conference, organised jointly by the European Cancer Patient Coalition and the European Hematology Association, the haematologists’ organisation, are crucial for raising awareness in the wider public, but also for sending a clear message to regulators, administrators, officials and MEPs that their voice needs to be heard.

Press Release: “Building the knowledge economy in the world of blood diseases: patients, professionals and Parliamentarians help make the new Europe.”

Wed, 09 Nov 2011 16:27:57 +0100

Brussels, 29^th August 2011

On the 30th & 31st of August a conference will be hosted in the European Parliament that will demonstrate the leading role haematology will have in securing the future knowledge economy envisaged in the Europe 2020 Strategy.

This will be revealed via an exploration of important interlinked legislative dossiers that will eventually realize the Strategy. The dossiers contain many issues which are of concern to both clinicians, their patients and their representatives.

Over the next two days we will explore these issues from a wide range of stakeholder perspectives seeking to set out clearly areas that are both contested and those upon which there is a consensus.

Addressing two of the three legislative dossiers on the conference agenda, the revision of the Common Strategic Framework (CSF) for funding research & innovation and the Clinical Trials Directive, will be their respective Rapporteurs Marisa Matias MEP and Philippe Juvin MEP.

Nessa Childers MEP, a high profile health committee member, will make her own contribution to the discussion of the CSF.

Commission representatives from relevant Directorates will also be present to discuss the dossiers and issues raised concerning them as they will for the Professional Qualifications Directive, the third legislative item to be covered.

This third dossier, in its Single Market policy ambition of the free movement of labour within the European internal market and its contribution to the development of a knowledge economy, need look no further for an illustrative example of its benefits than the Heamatology Curriculum.

Harmonization of continuing medical education by ensuring it be mandatory and enforceable will, when combined with the Curriculum, assist greatly in ensuring the diminution of public concerns about patient safety.

In recognition of Poland’s occupancy of the Presidency Pawel Kowal MEP will open the Conference with a Welcome message followed by Elżbieta Łukacijewska MEP who will talk about haematology and its specialist clinicians.

As Elżbieta will relate; the real mystery is of public ignorance of haematology and the work of haematologists.

This disadvantages the profession and patients who struggle to articulate what haematology is and in what way it is different from its nearest perceived cousin oncology.

However the story they have to tell is a compelling one. It is of forever being at the forefront of medical research both at its most fundamental level where it meets molecular biology and also in the application of that research which often now involves working closely with the biotechnology industries.

There is some public consciousness of stem cells, the huge research effort devoted to revealing their mechanics, and the applicability of the knowledge gained just as there is of imatinib the most spectacularly successful targeted therapy to date.

Yet there is almost zero public recognition of the role played by haematologists in this story. This should, and must change.

Remedial work will commence when a range of speakers reveal the links between these specialities and their rich resulting outputs. This will also serve to illustrate the importance of cross disciplinary coordinated research with academic institutions from across Member States working together to build the future knowledge economy for Europe.

Regulators will also speak of the need to ensure patient safety, the maintenance of assurance and the need for assessment no matter what the context of a patient’s encounter with practices and products they are resourcing to secure a better healthcare outcome.

The support of patients is of vital assistance in discussion of all of these issues since they carry only the self interest of ensuring their survival before them.

The wider public has an instinctive empathy with them because of their awareness that they too might one day joint the ranks of, as one patient put it, “the club that no one wants to join”.

Securing that implicit support and having that transmitted through those “club” members carries weight beyond what can be perceived as the self interest of the professional.

A patient organization & professional association, welded together when jointly organizing events like theses, can send a clear message to regulators, administrators, officials and MEPs that their voice needs to be heard.

For further information please contact:

Denis Horgan, ECPC Head of External Affiars		Thom Duyvené de Wit, EHA Advocacy & Political Affairs
ECPC Head Office Tel.: +32 (0)4 72535104 +32 (0)4 72535104 Email: denis.horgan@ecpc-online.org		EHA Executive Office Tel.: +31 (0)6 11115056 +31 (0)6 11115056 Email: t.duyvenedewit@ehaweb.org

About EHA - European Hematology Association

European Hematology Association is an NGO that promotes excellence in clinical practice, research and education in European haematology. EHA is the representative of haematology and haematologists in Europe (members: 3000+, annual congress attendants: +/-9000 haematologists, Haematologica/The Hematology Journal: the primary general haematology journal in Europe). Further information can be found at http://www.ehaweb.org

About ECPC – The European Cancer Patient Coalition

The European Cancer Patient Coalition was founded in 2003 under the slogan "Nothing About Us, Without Us". It is committed to improving cancer prevention, screening, early diagnosis and best treatment, reducing disparity and inequality across the EU. ECPC seeks to ensure that policy makers, politicians, health professionals, the media and the general public recognise the serious nature of cancer and the need for concerted action to reduce unnecessary death and suffering. Further information can be found at http://www.ecpc-online.org

Dr A van Hylckama Vlieg Announced Winner of the first EHA-ISTH Joint Fellowship

Mon, 21 Nov 2011 15:44:28 +0100

The award of EUR 72,000 over two years is intended to support the study of the physiology of bleeding, coagulation or thrombosis. Dr. van Hylckama Vlieg’s proposal, Ageing of the venous valves and the risk of venous thrombosis in the elderly, aims to clarify which factors predict venous thrombosis in the elderly. The study, referred to as BATAVIA (Biology of Ageing and Thrombosis: Appraisal of Valve thickness and function, an In vivo Assessment, is an extension of her previous work with the AT-AGE (Age and Thrombosis: Acquired and Genetic risk factors in the Elderly) study.

Dr van Hylckama Vlieg’s proposal was selected from 18 competitive submissions for this joint program of EHA and ISTH. “We are very pleased with the number of high-quality research proposals received in response to this initiative in its first year,” said Dr Ian Peake, Co-Chair of the EHA-ISTH Joint Fellowship Review Committee and a past president of ISTH.

“I am very happy to receive this award, said Dr van Hylckama Vlieg. It is an honor to be the first recipient of this unique collaboration between ISTH and EHA.”

Since 2009, Dr van Hylckama Vlieg has served a joint appointment as Senior Clinical Researcher with Leiden University in the Netherlands and the University of Washington in Seattle, Washington, USA. Her research has been focused on the combined effect between hormone use, such as contraceptives and hormone replacement therapies, and statins. Her general research interests have been on venous thrombosis, a common condition of clotting in the veins.

Prior to 2009 Dr van Hylckama Vlieg was a Clinical Researcher in the Department of Clinical Epidemiology at Leiden University Medical Center. She completed her PhD at Leiden University in 2003 and was a post-doctoral research fellow at Addenbrooke’s NHS Trust Hospital in the UK. Dr van Hylckama Vlieg’s work has been published in a number of international journals, including Blood, Journal of Thrombosis and Haemostasis, Arteriosclerosis, Thrombosis, and Vascular Biology and the British Medical Journal. She has been awarded a number of grants and prizes from organizations such as the Dutch Heart Foundation, Foundation LeDucq, and the British Society for Haematology, among others.

The call for applications for the next EHA-ISTH Joint Fellowship is open on the websites of EHA and ISTH.

New at EHA 15: EHA-JSH Joint Symposium

Mon, 21 Nov 2011 10:51:04 +0100

On behalf of JSH Dr Toshiki Watanabe will speak about "Molecular pathogenesis of ATL". Dr Herman Einsele presents EHA with his lecture "New treatments strategies for EBV-associated LPD as a model for immunotherapy of virus-associated/induced tumors". The symposium is chaired by the President of JSH Yuzuru Kanakura and Robin Foà President of EHA.