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Bioethic information and analysis newsletter

Following Letter

N°60 - December 2004

Draft law on the end of life : Passed almost unanimously

On 30th November 2004, the French National Assembly passed on first reading, almost unanimously (548 votes for and 3 abstentions) the draft Léonetti law « concerning the rights of the sick and at the end of life ». It defines a right to « allow to die » and rejects therapeutic tenacity, but stops short of legalising euthanasia.

No unreasonable obstinacy
The text states that treatment should not be pursued « with unreasonable obstinacy, when there is no hope of achieving an improvement in the state of health of the patient and that it involves artificially extending life» (art.1). The latter expression was preferred to therapeutic tenacity. A person in a terminal phase (or, if unable to express their wishes, the designated next of kin), may decide to limit or to curtail all treatment. They can authorise the administration of pain killers even if the latter accelerate death.

Confusion between treatment and care ?
In the draft documents, euthanasia is defined as the administration of a lethal substance, not the deliberate omission of vital care. Even if a treatment, which is considered unreasonable, may legitimately be curtailed, care remains due to the patient.

The question of feeding
In the presentation of the motives of the draft law, feeding is clearly considered as a treatment and not as care and the text specifies « by authorising a conscious patient to refuse all treatment, the device implicitly acknowledges the right to refuse artificial feeding ». Surely there is a danger in so doing to introduce in this way a form of euthanasia, by stopping feeding certain patients ? For example in the "Vincent Humbert case" would the text authorise to stop feeding Vincent, since apparently there was "no hope of achieving any improvement of (his) state of health" ? The associations campaigning for the legalisation of euthanasia say they are satisfied with the text even if they consider that it does not go far enough in its proposals and that it can only therefore be considered as a first stage.

Palliative care encouraged
The medical project of every major medico-social department or establishment accommodating the elderly will now have to include a « palliative activity in the departments » aspect and state the number of staff who will need to be trained, and the number of beds identified as such.

Umbilical cord blood stem cells : A means of avoiding the ethical and clinical dilemma

Their multipotency

A recent article in the Journal of Experimental Medicine¹ amazingly confirms the therapeutic potential of stem cells contained in the blood from the umbilical cord. Initially used by Dr. Eliane Gluckman for haematological grafts for children² then for adults³, the stem cells from the umbilical cord now promise many extra-haematological applications in heart, vascular, liver and neurone grafts. Collected in small quantities at birth, the stem cells in the blood taken from the umbilical cord were cultivated ex vivo without losing their multipotency and differentiated into homogeneous groups of adipocytes, hepatocytes, osteoblasts, chondroblasts, heart cells and neural cells. Known as unrestricted somatic stem cells (USSCs), these placentar stem cells managed to regenerate in vitro and in vivo bone, cartilage, liver cells, heart cells and neurones. Being less quiescent than adult stem cells, their plasticity is closer to embryonic stem cells, with the advantage that they do not exhibit any tumorigenic tendency after transplantation. The team at the Düsseldorf Medical School concludes that the blood from the umbilical cord « could thus be used as a universal source for cellular therapy and regenerative medicine » (J. Exp. Med., 2004 : 200, 2) without the need to resort to human embryos, therapeutic cloning, or medicine babies. Indeed, why produce embryonic clones when there are alternative techniques available which are medically effective and ethically legitimate ? Still only timidly mentioned in the public debate on embryonic and adult stem cells, the blood from the umbilical cord could represent the point of equilibrium between ethics and clinics, i.e. the middle of the road between respect for human life and the rights of patients to benefit from the advances in regenerative medicine.

Medicine child /discrimination

Why produce babies by IVF, then select them by pre-implantation diagnostics (PID), since in the end the intended aim consists in merely collecting some histocompatible blood from the umbilical cord for a graft ? In an emergency situation, why produce in such a complex way tailor-made live donors, whereas it would be possible to collect the same histocompatible graft without any gestation period if the placentar blood banks held a sufficient number of HLA types ? Beyond the major reservations regarding the reification and utilitarian approach to the medicine child, it should be pointed out that from an ethical point of view, this technique constitutes a characteristic form of positive discrimination, from the moment that the embryo is selected by PID on the sole criterion of its genetic profile. Yet the Oviedo Convention and the universal Declaration on the human genome are expressly in agreement to recall that « nobody should be subject to discriminations founded on their genetic characteristics »⁴. How can one resolve such a contradiction ? In fact the existence of the medicine child is related to its genotype ; it is the result of positive discrimination based on genetic characteristics. Legalised in France by the law dated 4th August 2004, the creation of medicine babies is based on the argument that, under certain conditions, the end (obtaining a histocompatible umbilical cord) justifies the means (selection of a child according to its genetic profile). Does the precipitate creation of a medicine child truly represent the only and unique option, is it the last chance ? In order to achieve the same therapeutic objective, the expansion of umbilical cord blood banks would doubtless provide an ethical, realistic and durable alternative.

Replacement of bone marrow banks

Governments remain to be convinced, however, of the need to invest in public placentar blood banks in order to increase the number of cryopreserved units, mutualize biological resources on a world-wide scale and finally, gradually overcome the chronic shortage of organ banks. Today there are some 170,000 units of umbilical cord blood held in 37 public banks to cover the needs of 6 billion individuals. In 2004, the American Congress adopted a budget of $150 million to provide its public banks with 150,000 units in 5 years, i.e. the equivalent of the total number of umbilical cord units in the world. The intended objective was to gradually replace the bone marrow banks with umbilical cord blood banks. Indeed, apart from their comparable effectiveness for haematological grafts in children and in adults  (N. Eng. J. Med. 2004, 351 ; 22), umbilical cord blood banks provide unequalled advantages compared with bone marrow registers, because the grafts are immediately available, are collected without risk and can be stored for up to twenty years.

The umbilical cord blood banks bring the promise of major clinical applications (heart, liver, bone, vascular, neuronal)  far outstripping the possible uses of bone marrow grafts. Following in the footsteps of the United States, Japan and Australia have also elected to give precedence to their umbilical cord blood banks, rather than investing in the recruitment of new bone marrow donors. Paradoxically, France recently decided to adopt the reverse policy by enlarging its register of bone marrow donors by 100,000 units between now and 2015, whilst limiting the number of umbilical cords to 5,000 units for a French population of 60 million. A pioneer in 1988, France is now relegated to the 14th position in the world with respect to the number of placentar blood units per inhabitant⁵.

1 Kögler G, Sensken S, Airey J, et al., A New Human Somatic Stem Cell from Placental Cord Blood with Intrinsic Pluripotent Differentiation Potential, Journal of Experimental Medicine, 2004 ; 200, n°2: 123-135.
2 Gluckman E, Broxmeyer HA, Auerbach AD, et al., Hematopoietic reconstitution in a patient with Fanconi’s anemia by means of umbilical-cord blood from an HLA-identical sibling. N. Eng. J. Med. 1989 ; 321 : 1174-8.
3 Rocha V, Labopin M, Sanz G, et al., Transplants of Umbilical-Cord Blood or Bone Marrow from Unrelated Donors in Adults with Acute Leukemia, N. Eng. J. Med. 2004 ; 351: 2276-85. See also Laughlin M, Eapen M, Rubinstein P, et al., Outcomes after Transplantation of Cord Blood or Bone Marrow from Unrelated Donors in Adults with Leukemia, N. Eng. J. Med. 2004 ; 351: 2265-75.
4 Unesco, Universal declaration on the human genome and the rights of man, 1997 : articles 2 and 6. Oviedo Convention on Human Rights and Biomedicine : article 11.
5 BMDW, Annual Report, 2004.

Cloning banned by the UNO : Defeat for the convention

When the small minority wins...
The session of the sixth commission of the UNO General Assembly, tasked with elaborating an international convention to prohibit human cloning, ended on 19th November without any agreement, despite a large majority (3/4) declaring itself against any form of cloning. In fact, on one side, backing Costa Rica, the vast majority of nations (62 nations) including the United States, support a ban on any form of human cloning (reproductive and so-called therapeutic), and the other, backing Belgium, 22 nations, including France, wish only to ban reproductive cloning and leave each nation to elaborate its own legislation regarding therapeutic cloning. The Islamic Conference Organisation, (ICO) on its part, through its official representative, Turkey, is seeking a consensus on the question. Turkey, on an individual basis, has declared itself in favour of the Belgian proposal. But opinions are split within the Conference : the Arab League member nations (included in the ICO) in June 2004 signed a proposed total ban on human cloning.

Towards a simple declaration
After avoiding a vote on a cloning ban, Belgium proposed working on a simple declaration prohibiting the cloning of "human beings". Italy tabled an amendment proposing to « prohibit any attempt to create human life by cloning and all research intended to achieve that end ». Finally, the commission, in accordance with the Belgian proposal, the leader of the nations not wishing to ban therapeutic cloning, decided to abandon the vote for a convention and proposed the establishment of a working group tasked with elaborating by February 2005 « a United Nations declaration on cloning », based on the Italian amendment. But whatever the final text which is adopted, remember that a declaration, as opposed to a convention, is not compulsory... The UNO despite a very large majority, would appear to have failed in its will to ban human cloning on a world-wide scale ?