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quinta-feira, 31 de março de 2016

Garoto chinês recupera visão após transplante de uma córnea de porco

11/03/2016 08h35 - Atualizado em 11/03/2016 08h35

Garoto chinês recupera visão após transplante de uma córnea de porco

Cirurgia foi feita na Universidade Zhongshan de Cantão.
Jovem perdeu visão no olho direito após ficar ferido por fogos de artifício.

Da Agência Efe
Um adolescente chinês recuperou a visão após passar por um transplante de córnea procedente de um porco, na província de Cantão, informou nesta sexta-feira (11) o jornal local "Southern Metropolis Daily".
Garoto chinês recupera visão após transplante de uma córnea de porco (Foto: Reprodução/Weibo/Ettodaynet)Garoto chinês recupera visão após transplante de uma córnea de porco (Foto: Reprodução/Weibo/Ettodaynet)




















A Universidade Zhongshan de Cantão realizou em fevereiro esta pouco habitual intervenção na qual os médicos, perante a escassez de córneas humanas na China, decidiram obter de um porco esta parte que forma a camada externa do olho.
O jovem de 14 anos, natural da vizinha província de Jiangxi, tinha perdido quase toda sua visão no olho direito após ficar ferido por fogos de artifício no início de ano.
Uma semana depois da operação, o paciente começou a recuperar a visão e os médicos esperam que continue melhando caso siga o tratamento prescrito.
Apesar do número de doadores ter crescido na China para 2.766 em 2015, um número recorde que coincidiu com a proibição do uso de órgãos de prisioneiros executados, o país asiático sofre com um enorme de déficit, já que estima-se que só cobre 1% da demanda de transplantes.


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CEBID - Centro de Estudos em Biodireito

Only in Sweden

Ernada Hidanovic and her son Armando, refugees in Sweden / Paul Madej      


The political and policing problems of allowing hundreds of thousands of refugees from Africa, the Middle East, and Afghanistan to plod into Western Europe tend to overshadow the difficulties of settling them into a new and alien society.
On the medical front countries in Western Europe are well prepared to cope with the massive influx, according to the World Health Organization. But inevitably there are exotic health issues. Female genital mutilation is one that has made headlines. One that hasn’t is “resignation syndrome” in refugee children and adolescents in Sweden.
This must be one of the most bizarre medical stories of the past decade, although it has received almost no publicity outside of Sweden. Hundreds of children and teenagers, aged 7 to 19, have been diagnosed with a mysterious ailment which leaves them unable to eat, speak and move. According to an article by Dr Karl Sallin and colleagues in Frontiers of Behavioural Neuroscience, the typical patient is “totally passive, immobile, lacks tonus, [is] withdrawn, mute, unable to eat and drink, incontinent and not reacting to physical stimuli or pain”.
Unless they are given intensive nursing care, they will die.
And it happens only in Sweden.
In 2014 Swedish medical authorities started calling the phenomenon “resignation syndrome”, but this is just a label, not a solution. All of the affected children are members of ethnic minorities, many of them from former Soviet republics, with a disproportionate share being Uighurs. Many of them have been traumatised by experiencing domestic abuse, witnessing violence or being harassed. But only children from refugee families are affected; unaccompanied children are not.
None of the conventional explanations hold water. It could be a reaction to stress and trauma. It could be a projection of the anxieties of traumatised mothers. But there are 50 million traumatised refugees scattered all over the world. Why does “resignation syndrome” happen only in Sweden?
Dr Sallin proposes a two-fold diagnosis in his article. He argues that the affected children are actually suffering from an old and well-studied ailment: catatonia. They are conscious, but unable to move or respond, even to painful stimuli.
His second point is more controversial. He maintains that it is a kind of mass hysteria. Jean-Martin Charcot, a French neurologist in the late 19th century, was the first to characterise this phenomenon. The symptoms of his patients, mostly women, were recurring fits, often quite bizarre, which seemed to follow a standard path of growing severity.
After ruling out a physical cause, he concluded that the cause was psychological, and the ailment was transmitted by imitating other people’s hysterics. When the symptoms became “unfashionable”, the hysterical fits declined. Sallin believes that symptoms of hysteria evolve over time “through the continuous negotiation between physicians and patients immersed in cultural context”. This leads him to suggest that the refugee children are suffering from a mass psychogenic illness tailored for people in their community, just as in past outbreaks.
So this leads us to the bioethical angle to this strange phenomenon. Publicising the illness in the media may make the public more aware of a pressing public health issue, but it may be spreading it at the same time. And indeed it appears that there was a peak in cases of “resignation syndrome” when it was given extensive coverage in the media.
So Sallin concludes with a morose reflection upon the dilemma that doctors find themselves in. As physicians they are bound to tube-feed their catatonic patients, but caring for them may cause the syndrome to spread even further: “The appeal to culture-bound psychopathology raises an ethical dilemma … by offering treatment, to which there is no alternative, we are also, on another level, causing new cases.” 



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CEBID - Centro de Estudos em Biodireito

More bracket creep in Belgian euthanasia



Three bills which could significantly expand the scope of euthanasia in Belgium have been proposed by Laurette Onkelinx, the leader of the Belgian Socialists and a former Deputy Prime Minister.
The first (PDF) would remove a five-year sunset clause for advance declaration of a patient’s willingness to accept euthanasia. This would mean that a document written 20 or 30 years before would be valid, no matter what a patient might have thought in recent times.
The second (PDF) would force doctors to give a rapid turn-around to requests for euthanasia. They would have to answer within seven days. If they refused, they would have to transfer the patient’s file to a doctor who would be willing to give a lethal injection. This threatens to remove physicians’ right to conscientious objection to euthanasia. It would also force doctors to treat a request as a matter of urgency, even though it might have come during a psychological crisis which would soon pass.
The third (PDF) would remove the right of institutions like hospitals or nursing homes to refuse to allow euthanasia on their premises. Ms Onkelinx insists that institutions have no right to conscientious objection; only doctors do. Her bill affirms a doctor’s right to follow his conscientious belief in the practice of euthanasia. In an explanatory memorandum, she invokes the principle that “a doctor can be neither forced to nor prevented from practicing euthanasia in legal conditions, wherever he might be.”


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CEBID - Centro de Estudos em Biodireito

UK health service may harvest organs from babies with lethal defects


The UK’s National Health Service is to encourage pregnant women whose children have a fatal birth defect to bring them to term so that their organs can be harvested. This shocking story was reported by the Mail on Sunday, so it must be taken with a grain of salt. However, the newspaper quotes a number of doctors who support the idea  and cites plans being studied by the NHS.
The proposal was apparently mooted at the annual conference of the British Transplantation Society in Glasgow. 
Transplant surgeon Niaz Ahmad, of St James's University Hospital in Leeds, said: “We are looking at rolling it out as a viable source of organ transplantation nationally. A number of staff in the NHS are not aware that these organs can be used. They need to be aware. These can be transplanted, they work, and they work long-term.”
Apparently anencephalic babies are ideal for this purpose. These are children who are born without a brain, or with very little brain tissue. In today’s UK hospitals 230 are aborted annually and only 12 brought to term. However, more and more women are deciding not to abort the child, according to Dr Joe Brierley, a specialist at Great Ormond Street Hospital for Children in London. Women who have made this decision could be counselled that their child’s organs could benefit other patients. Near the time of birth the child would be pronounced brain-dead and its organs removed.
However, the newspaper reports that NHS Blood and Transplant said: “Under no circumstances would our staff or anybody else within the NHS pressure women to continue with a pregnancy solely for the possibility of organ donation.” 
Dr Brierley defended the plans vigorously:
Given that three people a day die waiting for an organ transplant, I welcome anything that improves the number of donors. Helping the families of those dying in intensive care to have the best information to make this decision is vital. With anencephaly, such discussions occur with a woman who has been told her pregnancy may result in stillbirth, or – if the baby is born alive – it will die as a newborn.
Whilst provision of such information is the cornerstone of good care, my view is that this should not be used to persuade a woman not to undergo termination. However, if a decision is made to continue the pregnancy for other reasons, then all palliative care options – including donation – ought to be discussed.
Bioethicist Dr Trevor Stammers told the Mail on Sunday that the suggestion was “abhorrent”. “It is a ghoulish suggestion that can only undermine public confidence in transplantation – one of the greatest medical advances of my lifetime. The concept reduces the baby to nothing more than a utilitarian means to an end – a collection of spare parts – rather than respecting life for its own sake.”



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CEBID - Centro de Estudos em Biodireito

Et si Alzheimer venait d'un virus ?

Et si Alzheimer venait d'un virus ?

Par Marion Degeorges

L'herpès est dans le viseur des chercheurs qui étudient la piste des virus et des bactéries pour comprendre le développement de la maladie d'Alzheimer.

Malgré plusieurs centaines d'essais cliniques, Alzheimer reste invincible. C'est notamment ce constat qui a poussé un groupe de 31 chercheurs du monde entier à signer une tribune dans le « Journal of Alzheimer's Disease » pour appeler à investiguer de toute urgence une piste qu'ils estiment jusqu'ici « négligée ».
Leur regard accusateur se dirige droit vers un lien probable entre Alzheimer et les virus et les bactéries. Un virus en particulier retient leur attention : celui de l'herpès. Selon eux, ce virus, ainsi que les bactéries chlamydia et spirochètes, sont les principaux coupables dans le développement de la maladie dégénérative.
« Nous disons que, de toute évidence, il existe un élément microbien en sommeil dans le développement de la maladie d'Alzheimer. Nous ne pouvons plus ignorer toutes les preuves », revendique le professeur Douglas Kell de la School of Chemistry de l'Université de Manchester, auprès du « Telegraph ».

L'origine de la formation des plaques

Pour l'heure, dans la lutte contre Alzheimer, la plupart des chercheurs se concentrent sur les pathologies amyloïdes. Soit, quand un type de protéine s'agglomère dans le cerveau et forme des plaques, ce qui empêche les neurones de communiquer normalement et provoque la perte de mémoire et les problèmes cognitifs.
Mais dans leur édito, les 31 chercheurs affirment que ce serait en fait une infection virale ou bactérienne qui provoquerait la formation de ces plaques en premier lieu. De fait, cibler précisément ces infections avec un traitement antimicrobien « pourrait ralentir, voire stopper la progression d'Alzheimer », écrivent-ils.
« Nous faisons référence à plusieurs études, principalement conduites sur des hommes, qui impliquent des microbes spécifiques au cerveau âgé, et plus particulièrement l'Herpès simplex type 1, la Chlamydia pneumoniae, et plusieurs types de spirochètes », précisent-ils dans leur édito.

L'herpès touche deux personnes sur trois

Le virus de l'herpès est connu pour endommager le système nerveux central, et le système limbique (qui joue un rôle important dans la gestion des émotions et la formation de la mémoire), rappelle le « Telegraph ». Au cours de leur vie, environ 2/3 des hommes et des femmes attrapent le virus de l'herpès. Mais beaucoup ne s'en rendent pas compte.
Selon ces 31 spécialistes, même si des bactéries ou des virus sont « en sommeil » dans le cerveau, ils peuvent très bien « se réveiller » après un stress, ou si le système immunitaire est affaibli.
Il est prouvé que les virus, les bactéries et même les champignons sont courants dans le cerveau des personnes âgées, « mais il apparaît aussi qu'il y en a davantage chez les personnes qui sont mortes de la maladie d'Alzheimer », affirme de son côté le Docteur James Pickett, directeur des recherches à l'Alzheimer's Society.

Qui dit virus dit transmission

Pas de panique, veut cependant rassurer le Docteur Pickett. « Alors même que ces recherches sont intéressantes et méritent d'être approfondies, pour l'heure, les preuves qui permettraient d'affirmer que la majorité des cas d'Alzheimer sont dus à un microbe sont insuffisantes. Nous voulons rassurer les gens sur le fait qu'il n'existe pas de preuve qu'Alzheimer est contagieux, ou peut se transmettre d'une personne à l'autre comme un virus », affirme-t-il.
« Nous proposons que davantage de recherches sur le rôle des agents infectieux dans l'apparition de la maladie d'Alzheimer soient conduites, y compris des études prospectives de traitements antimicrobiens », demandent d'ailleurs les 31 chercheurs dans leur tribune.
Selon eux, les potentiels résultats pourraient également avoir des conséquences sur le traitement de la maladie de Parkinson, ainsi que d'autres maladies neurologiques, rapporte le « Telegraph ».
En France aujourd'hui, environ 900.000 personnes sont atteintes d'Alzheimer. Et si rien ne change, en 2020, la maladie touchera un français sur quatre de plus de 65 ans, soit 1,3 million de personnes.
















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CEBID - Centro de Estudos em Biodireito

terça-feira, 29 de março de 2016

CONVITE - LANÇAMENTO DO LIVRO ENSAIOS SOBRE A INFÂNCIA E A ADOLESCÊNCIA







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CEBID - Centro de Estudos em Biodireito

Comissão aprova realização de testes da fosfoetanolamina em humanos


Comissão aprova realização de testes da fosfoetanolamina em humanos

Conep aprovou a pesquisa com o composto em pacientes com câncer.
Secretaria da Saúde afirma que ainda não foi informada sobre o parecer.

Do G1 São Carlos e Araraquara
Fosfoetanolamina sintética (Foto: Ely Venâncio/EPTV)Fosfoetanolamina sintética vai ser fornecida a pacientes de estudo (Foto: Ely Venâncio/EPTV)













A Comissão Nacional de Ética em Pesquisa do Conselho Nacional de Saúde (Conep) informou aoG1 nesta terça-feira (8) que o protocolo de pesquisa com a fosfoetanolamina sintética foi aprovado. O parecer era necessário para o início da pesquisa anunciada pela Secretaria de Estado da Saúde de São Paulo, que informou ainda não ter sido comunicada oficialmente.
Distribuída pela USP de São Carlos por causa de decisões judiciais, a fosfoetanolamina é alardeada como cura para diversos tipos de câncer, mas não passou por testes em humanos, por isso não é considerada um remédio. Ela não tem registro na Agência Nacional de Vigilância Sanitária (Anvisa) e seus efeitos nos pacientes são desconhecidos.
Furp em Américo Brasiliense não poderia sintetizar as cápsulas (Foto: Ely Venâncio/EPTV)Composto será encapsulado na Furp de Américo
Brasiliense (SP) (Foto: Ely Venâncio/EPTV)
Segundo a Conep, o protocolo foi aprovado na última sexta-feira (4) com uma recomendação, de retirar a limitação proposta ao ressarcimento de transporte e alimentação para os participantes nos dias de visita. Também ficou estipulado que a pesquisa será acompanhada pelo Comitê de Ética da Faculdade de Medicina da Universidade de São Paulo (USP).
"É uma questão simples que pode ser resolvida em poucos dias e não atrapalhará o início da pesquisa em abril, conforme proposto. O protocolo tramitou três vezes na Conep até a aprovação e o tempo total somado na Conep foi de quinze dias", informou Jorge Alves de Almeida Venancio, coordenador da comissão que tem como principal atribuição o exame dos aspectos éticos das pesquisas que envolvem seres humanos.
O laboratório PDT Pharma, que vai sintetizar o composto para os testes clínicos no Estado, informou que aguarda a chegada de equipamentos específicos e que espera iniciar a produção na última semana de março.
Estudo clínico
A pesquisa será coordenada pelo Instituto do Câncer do Estado de São Paulo e envolverá outros três centros públicos de saúde no Estado, com investimento estimado pelo governo em R$ 5 milhões.
Segundo Secretaria de Estado da Saúde, na primeira fase, serão avaliados 10 pacientes para determinar a segurança da dose que vem sendo utilizada na comunidade. Após essa primeira etapa, caso o composto não apresente efeitos colaterais graves, a pesquisa prosseguirá com até mil pacientes.
A pasta disse nesta terça-feira (8) que ainda não tem informações sobre o processo de seleção de interessados em participar dos testes.
Ministério
O Ministério da Ciência, Tecnologia e Inovação, que em articulação com o Ministério da Saúde também está realizando pesquisas com o composto, informou que os ensaios pré-clínicos continuam.
"A estimativa é de que, após a finalização dos ensaios pré-clínicos, o que possivelmente ocorrerá no 2° semestre de 2016, já poderão ser iniciados os testes clínicos de fase I em humanos, caso os estudos pré-clínicos demonstrem que o composto é seguro", afirmou a assessoria de imprensa da pasta.
Fosfoetanolamina sintética foi desenvolvida por pesquisadores da USP de São Carlos (Foto: Reprodução/EPTV)Fosfoetanolamina foi sintetizada por pesquisadores
da USP de São Carlos (Foto: Ely Venâncio/EPTV)
Pelo plano de trabalho do ministério, os testes pré-clínicos e os estudos clínicos de fase I devem ser executados pelo Núcleo de Pesquisa e Desenvolvimento de Medicamentos da Universidade Federal do Ceará (NPDM/UFC) e pelo Centro de Inovação de Ensaios Pré-Clínicos (CIEnP).
"As análises estão transcorrendo conforme o cronograma inicial", disse o ministério. "Neste sentido, está sendo finalizado o primeiro relatório das atividades realizadas pelos laboratórios e o mesmo será publicado, possivelmente ainda no primeiro trimestre, nowebsite dedicado à fosfoetalonamina", completou.


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CEBID - Centro de Estudos em Biodireito

Primeira mulher a receber transplante de útero nos EUA teve que tirar órgão

09/03/2016 19h24 - Atualizado em 09/03/2016 19h25

Primeira mulher a receber transplante de útero nos EUA teve que tirar órgão

Segundo instituição, paciente teve complicações, mas passa bem.
Em nota, paciente agradeceu por orações e pensamentos positivos.

Do G1, em São Paulo
 Lindsey (que não quis divulgar seu sobrenome) e seu marido Blake apresentaram-se para a imprensa ao lado da equipe médica da Cleveland Clinic nesta segunda-feira; ela foi a primeira a receber um transplante de útero nos EUA  (Foto: Marvin Fong/The Plain Dealer via AP)Lindsey (que não quis divulgar seu sobrenome) e seu marido Blake apresentaram-se para a imprensa ao lado da equipe médica da Cleveland Clinic nesta segunda-feira; ela foi a primeira a receber um transplante de útero nos EUA, mas teve de retirar órgão (Foto: Marvin Fong/The Plain Dealer via AP)



























A primeira paciente que recebeu um transplante de útero nos Estados Unidos teve o órgão retirado devido a complicações, segundo nota divulgada nesta quarta-feira (9) pela Cleveland Clinic, instituição responsável pelo procedimento.
A cirurgia foi feita no dai 25 de fevereiro e, nesta segunda-feira, a clínica tinha anunciado que a paciente tinha uma boa evolução. Agora, as circunstâncias da complicação estão sendo investigadas, segundo a clinica.
"Enquanto isso tem sido difícil tanto para a aciente quanto para a equipe médica, Lindsey passa bem e está se recuperando. O estudo, que planeja incluir 10 mulheres, está em andamento com o compromisso de obter avanço da pesquisa médica e uma opção a mais para mulheres e suas famílias", afirma a nota divulgada ela instituição.
"Infelizmente, eu perdi o útero devido a complicações. No entanto, eu estou bem e agradeço por todas as preces e pensamentos positivos", afirmou Lindsey, paciente que não quis ter o sobrenome divulgado, também em nota.
Caso de sucesso na Suécia
Em 2014, em um feito inédito da medicina, umamulher da Suécia deu à luz depois de receber um transplante de útero.
A mãe, de 36 anos, recebeu o útero de uma amiga próxima de sua família no ano passado. Seu bebê, um menino, nasceu prematuro, mas saudável.
Na Turquia, houve um caso de uma paciente que, depois do transplante de útero, ficou grávida, mas acabou perdendo o bebê.
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CEBID - Centro de Estudos em Biodireito

Incisão pioneira com células-tronco regenera olhos de crianças com catarata Procedimento conseguiu recuperar parte do olho de crianças afetadas pela doença na China.

James GallagherEditor de Saúde da BBC News
 Técnica de uso de células-tronco para tratar catarata foi testada em crianças, mas testes em pacientes mais velhos já começaram (Foto: Stephen Jaffe/AFP)Técnica de uso de células-tronco para tratar catarata foi testada em crianças, mas testes em pacientes mais velhos já começaram; foto de 1999 mostra paciente em cirurgia tradicional de catarata (Foto: Stephen Jaffe/AFP)
Um procedimento pioneiro feito por médicos conseguiu restaurar, a partir de células-tronco, o olho de crianças vítimas de catarata na China.
Mais da metade dos casos de cegueira são causados por catarata, quando o cristalino - a lente natural existente no globo ocular - fica opaco.
Em geral, o tratamento de catarata consiste no implante de uma lente artificial.
Já o novo procedimento, descrito na revista especializada "Nature", ativou células-tronco no olho para desenvolver uma nova lente.
Especialistas descreveram o tratamento como um dos maiores avanços na medicina regenerativa.
Tratamentos e complicações
Cerca de 20 milhões de pessoas no mundo todo perderam a visão devido à catarata. A doença é comum mais entre idosos, mas afeta algumas crianças desde o nascimento.
Os tratamentos tradicionais usam ultrassom para amolecer e quebrar a lente natural deficiente. Em seguida, ela é retirada do olho. Uma lente intraocular artificial é então implantada no olho, mas esse procedimento pode resultar em complicações, principalmente em crianças.
A nova técnica desenvolvida por cientistas da Universidade Sun Yat-sen, na China, e da Universidade da Califórnia em San Diego, Estados Unidos, remove a catarata da lente interna do olho através de uma incisão minúscula e deixa a superfície exterior, chamada de cápsula da lente, intacta.
A estrutura é então forrada com as células-tronco epiteliais, que geralmente reparam os danos.
A lente de células-tronco fica atrás da pupila e focaliza a luz na retina.
Segundo os cientistas, o novo procedimento foi feito em 12 crianças depois de testes feitos em coelhos e macacos terem sido bem-sucedidos.
Em oito meses, as lentes de células-tronco já chegavam ao tamanho normal.
"Esta é a primeira vez que uma lente completa foi regenerada. As crianças passaram pela cirurgia na China e continuam muito bem, com visão normal", disse Kang Zhang, um dos pesquisadores.
O procedimento também teve uma taxa de complicações muito menor.
Mas, de acordo com o Kang Zhang, são necessários mais testes antes que esse tratamento se transforme no padrão para tratar crianças com catarata.
Crianças e idosos
O procedimento foi testado em crianças pois suas células-tronco epiteliais da lente do olho são mais jovens e têm uma capacidade maior de regeneração do que as de idosos.
Mas a grande maioria dos casos de catarata acontece em idosos.
Zhang afirma que já começaram os testes em pacientes mais velhos e os primeiros resultados "parecem promissores".
Para Robin Ali, do Instituto de Oftalmologia do Universidade College London, mesmo ainda estando na fase de testes, o trabalho dos cientistas chineses e americanos é "formidável".
"Esta nova abordagem oferece uma perspectiva muito melhor de tratamento para a catarata pediátrica, porque resulta na regeneração de uma lente normal que cresce naturalmente", afirmou.
Para Ali pode ser mais difícil conseguir resultados parecidos em adultos, mas o impacto pode ser grande.
"Pode ser superior às lentes artificiais implantadas atualmente pois as lentes naturais podem permitir que a pessoa enxergue em distâncias diferentes de forma mais eficaz", afirmou.
"O estudo é uma das maiores conquistas no campo de medicina regenerativa até o momento. É o melhor da ciência", disse Dusko Ilic, palestrante em ciência de células-tronco no King's College de Londres.
Potencial
Kang Zhang acredita que usar células-troncos dos olhos tem um "grande potencial" para tratar uma grande variedade de doenças além da catarata, como degeneração macular e glaucoma.
Um outro estudo realizado pela Universidade de Osaka, no Japão, e pela Universidade de Cardiff, na Grã-Bretanha, usou células-tronco para produzir outros tecidos do olho.
Neste estudo os cientistas conseguiram produzir uma série de tecidos oculares incluindo os que fazem parte da córnea, conjuntiva, lente e retina.
"Nosso trabalho não apenas tem potencial para o desenvolvimento de células para tratamento de outras partes do olho, mas também pode estabelecer a base para testes humanos no futuro e transplantes (...) para restaurar a função visual", disse Andrew Quantock, um dos pesquisadores.




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CEBID - Centro de Estudos em Biodireito

“At some point, I stopped looking back”





A man who has suffered for 14 years from Amyotrophic Lateral Sclerosis (ALS) has been a named president of the Agenzia italiana del farmaca (AIFA)- the peak body for regulating pharmaceutical products in Italy.
Mario Melazzini was named president by the Minister of Health in January 2016, after the previous president stood down as a result of accusations of conflict of interest. Melazzini, a 57-year-old doctor, was diagnosed with ALS in 2002. The average life expectancy for sufferers with this condition is around five years. Melazzini himself is wheelchair-bound and depends on a ventilator and on parenteral nutrition. In the summer of 2003 he had an appointment at an assisted suicide clinic in Switzerland; but he never showed up. Melazzini describes his change of plans simply: “at some point, I stopped looking back”.
In 2006, as president of the Italian Association of ALS patients, Melazzini intervened in the euthanasia debate in Italy that surround the case of Piergiorgio Welby. Among the goals he has in his new role, Melazzini says he wants to encourage the use of generic and biosimilar medicines, and to reinvest money saved to research diseases such as Hepatitis C. 
Dr Phil Elias writes from Rome. 


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CEBID - Centro de Estudos em Biodireito

terça-feira, 22 de março de 2016

Costa Rica’s battle with IVF


Couples who want Costa Rica's IVF ban lifted in a meeting last year with President Luis Guillermo Solís
In most countries, IVF is a fact of life, even if it is constantly caught up in controversy. However, in the Central American nation of Costa Rica, it has been banned since 2000. And four years after an international court ordered Costa Rica to lift the ban, the country’s legislature and courts are still successfully stalling.
The Inter-American Court of Human Rights (IACHR) ruled in 2012 that lack of access to IVF  infringed a right to private and family life. However, Costa Rica’s constitution says that life begins at conception and IVF is criticised because it involves wastage of embryos. The constitutional court banned it in 2000 for that reason.
So IVF has become a political football.
Last year President Luis Guillermo Solís signed a decree to legalise IVF but the constitutional court annulled it, arguing that IVF should be regulated by law and not by presidential decree. Now the IACHR has ruled that a presidential decree is sufficient.
The president is under pressure from six couples who sued Costa Rica after the constitutional court’s decision in 2000. They say that they can no longer wait, as their fertility is waning.




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CEBID - Centro de Estudos em Biodireito

Nurse ignites debate over euthanasia in Portugal



The head of Portugal's national nurses' association has blown the whistle on covert euthanasia in public hospitals. Ana Rita Cavaco told a radio program that she personally had heard doctors discussing the topic.
She declared on the Catholic station Rádio Renascença, that euthanasia “is sometimes practiced in the health service hospitals, with doctors suggesting this solution for some patients”.
“I have personally witnessed such situations - I don’t need to look for further other examples. I have seen cases where doctors have suggested administering insulin to induce an insulin coma. I am not going to shock anybody as everyone who works in the health service knows these things happen out of sight and sound, so let’s talk about it openly.”
She gave no details, but the mere suggestion was enough for Portugal’s national medical association to demand that she be prosecuted for alleging that doctors were participating in an illegal activity. The association declared that Portuguese should have complete confidence in doctors.
"These statements can not be passed over in silence with the swiftness with which they were uttered. They are libellous and undermine the dignity of doctors and nurses, so it must be proven or clearly and formally denied".
The Health Ministry has ordered an urgent inquiry into the allegations.
The controversy comes at a sensitive time in Portugal as Parliament will probably debate euthanasia later this year, after a high-profile petition secured enough signatures to bring the matter before the legislature. 

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CEBID - Centro de Estudos em Biodireito

Bioethics and natural law: an interview with John Keown




Bioethics discourse is often divided into two broad categories: utilitarian perspectives and so-called deontological or Kantian approaches to ethics. An alternative viewpoint that receives far less attention is a natural law perspective on ethics and medicine. The natural law approach emphasizes interests or ends common to all members of humanity, and offers a teleological account of morality and human flourishing.
Professor John Keown of Georgetown University’s Kennedy Institute for Ethics recently co-authored a book on natural law with the late Georgetown Professor Alfonso Gómez-Lobo. The book is entitled Bioethics and the Human Goods: An Introduction to Natural Law Bioethics. The Deputy Editor of BioEdge, Xavier Symons, interviewed Professor Keown about his latest work. 
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Xavier SymonsWhat led you to write Bioethics and the Human Goods: An Introduction to Natural Law Bioethics?
John Keown: The book was largely written by my distinguished colleague and friend, the late Professor Alfonso Gómez-Lobo, who held the Ryan Chair in Metaphysics and Moral Philosophy at Georgetown. Before his untimely death at the end of 2011, he had submitted a manuscript to Georgetown University Press. With the kind permission of his widow, and with the approval of the Press, I completed the project, incorporating amendments that he had indicated, in his comments on the referees’ reports, that he wanted to make, and some amendments that I thought appropriate. About a third of the book is material I added to his original manuscript. I thought it important, given the regrettable dearth of introductory books on bioethics from a natural law perspective, that his manuscript should be enlarged, updated and completed
What contribution do you think natural law can make to the field of bioethics?
Natural law has made, and has the potential to make in future, a signal contribution to the ethics of healthcare and to bioethics more broadly conceptualised.  Natural law theory could be described as the most enduring and important moral tradition in Western thought, and it has had a profound influence on Western law, professional medical ethics, and culture.
Many laws and codes of ethics are grounded in the natural law articulation of certain fundamental moral principles that should always be respected, regardless of the consequences. For example, in relation to euthanasia, the prohibition on intentionally killing patients, which is still reflected in the law of the vast majority of jurisdictions, and in the ethics of the World Medical Association, is grounded on one such principle: the principle that it is always wrong intentionally to kill a person, even at that person’s request. 
Unlike other approaches to bioethics, most notably utilitarianism, natural law theory can offer a coherent account of the intrinsic wrongness of treating patients in certain ways, such as intentionally killing them, lying to them, or exploiting them, however beneficial it might be to others or to society to do so.
Moreover, although utilitarianism and ‘principlism’, in their various forms, are undoubtedly dominant in bioethics education today, it is important for students to realise that there is an alternative ethical tradition, one which makes sense of much of contemporary law and professional ethics, and which offers a radically different approach to bioethical reflection. Indeed, it seems to me that no student can understand bioethics (or, indeed, biomedical law) properly without at least a basic grasp of natural law theory. Without such a grasp, they have at best a partial understanding of the field. I fear that the many students of bioethics who are unfamiliar with the natural law tradition do not even know what they do not know.
Unfortunately, although the literature on bioethics is vast, that literature largely either ignores natural law theory, mentions it only in passing, or misunderstands it. There is, therefore, an important and urgent need for this book, and more books like it.  
I have lost count of the number of times I have been asked ‘Could your recommend a clear, introductory book on natural law bioethics, suitable for the college student or the general reader?’ Now, I have a ready answer. Previously, I recommended one or two books like Professor Gómez-Lobo’s Morality and the Human Goods (Georgetown University Press, 2002). However, although that book does touch on a number of bioethical issues (especially abortion and euthanasia), it is more an introduction to natural law ethics rather than natural law bioethics.  Still, it would make an excellent companion volume, and I think students would find it valuable to read it before reading Bioethics and the Human Goods.
Professor John Keown

The book mentions ‘basic goods’ and their importance for natural law theory. What are they and why are they so important?
The starting-point for natural law theory is to ask ‘What is the Good Life?’ It rejects standard utilitarian answers, whether in terms of pleasure or the satisfaction of desires, both of which could be used to justify obviously immoral acts. The answer given by natural law theory is that the Good Life is a life which involves true human fulfilment or flourishing. And what is a truly flourishing life? One in which one participates in the goods of life, health, friendship, knowledge, appreciation of art and beauty, work, play and practical reasonableness. (The precise formulation of basic goods may vary depending on which theorist one reads, but the theorists share the same, basic idea.) These goods are ‘basic’ in the sense that they are not merely instrumental goods, but are ends in themselves, worth pursuing for their own sake, and self-evidently so. (Of course, basic goods like health and knowledge can also be instrumentally valuable, but that does not reduce their worth to mere instrumentality. It is, for example, good for us to know about bioethics, or the history of the American Revolution, or one’s own personal history, even if one never uses that knowledge instrumentally.)
The basic goods form an objective basis for natural law ethics, but they need to be supplemented by intermediate moral principles, intermediate between the basic goods and our judgment about the ethics of particular conduct (‘Is it right for me to tell the patient he is fine when I know he is dying?’ ‘Should I allow the patient’s refusal of consent to prevent me from carrying out harmless and potentially ground-breaking research on her while she is anaethetised?’)  Much of Professor Gómez-Lobo’s book Morality focused on the key principles of ‘care’ and ‘respect’. In Bioethics he reformulates them in terms of ‘beneficence’ and ‘non-maleficence’. In doing so, he recognises the influential ‘four principles’ approach advocated by Professors Tom Beauchamp and Jim Childress, but he explains how those principles are conceived and applied from a natural law, rather than from a principlist, perspective. He rejected the ‘four principles’ approach on the ground that it failed to give a substantive account of the Good. Without such an account, he argued, it is impossible to judge what truly benefits or harms another.
In your book you suggest that, although natural law theory is compatible with major religious traditions, it is not grounded in religion. Can you explain?
Adherents of the great religions will find much in natural law that resonates with their teachings, such as its insistence that all human beings share a fundamental equality-in-dignity, including the most vulnerable, whether babies, people with profound intellectual disabilities, the comatose, the demented, the suffering and the dying.
For example, natural law theory’s opposition to infanticide (in contrast to its endorsement by leading utilitarians) resonates with the long-standing opposition to infanticide in the Judaeo-Christian tradition (in contrast to its endorsement by the ancient Greeks and Romans).  Natural law thinkers reject the ‘dualist’ notion of personhood, in which only some human beings, with certain mental abilities, count as ‘persons’ and others, like babies or elderly folk with severe dementia, do not.  Moreover, natural law theory is the philosophical tradition of the Catholic church.  Further, my brother Professor Damien Keown has, in his many publications, noted similarities between natural law ethics and Buddhist ethics. 
Despite these resonances between natural law theory and teachings of the great religions, however, natural law theory remains a philosophy, not a theology. It traces its origins to pre-Christian Greek thinkers like Aristotle, and is reflected in contemporary human rights documents in what many would describe as our post-Christian world.  Anyone can, and many do, adopt natural law’s absolute prohibitions on, say, torture or euthanasia, without having any religious belief whatsoever. In short, natural law is grounded on reason, not faith.
Is there not some distance between natural law theory and a detailed practical ethics? How can a medical practitioner use it to address thorny ethical issues in clinical practice?
There is always a distance between theory and practice, whichever ethical theory one adopts. But, partly because of the centuries-long history of the natural law tradition, much of the intellectual heavy lifting about its application to practical situations has already been done. That rich storehouse of reflection has shaped our laws and codes of professional ethics, whether in relation to carrying out research on patients, to treating or withholding treatment, and to killing or not killing.
That is not to say that natural law has figured out definitive answers to all the bioethical questions clinicians face in the contemporary world, but many of these questions are largely old questions in a new form. For example, the question of the moral status of the human embryo in vitro may have seemed utterly novel to many, but natural law theorists have been reflecting on the moral status of human embryos in vivo for centuries.  Again, the question whether to withhold or withdraw tube-feeding from a patient in PVS may, again, seem completely new and to require us to invent new ethical principles, but to natural law thinkers the answer lies in applying established ethical criteria which ask whether tube-feeding is a medical treatment and, if so, whether it is disproportionate as being either futile or too burdensome. This is not to suggest that the answers to such questions are easy, and will always attract consensus (even among natural law theorists) but it is to say that even challenging, contemporary bioethical questions can be resolved by the intelligent application of well-established principles.
In any event, we should not forget that most clinicians, most of the time, are not confronted with complex, thorny bioethical issues.  Most bioethical issues they face in everyday practice are fairly easily resolved by the application of established principles and codes of bioethics, such as those requiring informed consent and respect for confidentiality. And those principles and codes often reflect, to a greater or a lesser extent, natural law thinking, which requires respect for the basic rights and equality-in-dignity of each patient, not least the vulnerable, and that patients never be used as a mere means to the good of others. 
What would you say to natural law critics of the ‘new’ natural law theory which has been championed by philosophers like Grisez and Finnis?
Professors Grisez  and Finnis (and their collaborators, not least Professor Boyle) have been largely responsible for the exciting renaissance of natural law theory over the past 35 years or so. They would resist the label ‘new’ natural law on the ground that their theory is but a modern restatement of classical natural law theory. Not all natural lawyers would agree with that, but it seems to me that many of the criticisms are based on misunderstandings of the ‘new’ natural law project. This is one reason I co-edited (with Professor Robert P George of Princeton) a Festschrift in honour of John Finnis, (Reason, Morality and Law: The Philosophy of John Finnis) which was published by Oxford University Press in 2013, to allow both supporters and critics of his new classical theory to engage with him, and him with them.
In any event, college students and health care professionals interested in learning the basics of natural law bioethics may well find disagreements about whether and if so how the new classical theory of natural law differs from the old rather abstract and abstruse, and I would encourage them to start with some of the more introductory books and articles on natural law bioethics, written by scholars including Christopher Kaczor, Christopher Tollefsen, David Oderberg, Luke Gormally, David Jones, Helen Watt  and, of course, the late Alfonso Gómez-Lobo.







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