Mostrar mensagens com a etiqueta Bioética. Mostrar todas as mensagens
Mostrar mensagens com a etiqueta Bioética. Mostrar todas as mensagens

quarta-feira, 4 de dezembro de 2013

A Programme for the future with one foot in the past - There were strong reasons for the EU not to miss the opportunity to take a step forward with regard to funding stem cell research - by José Ramos-Ascensão

In europeinfos
 
Seven years ago, in a Press release of 22.12.2006 relating to the final adoption of the 7th Research Framework Programme (FP7), the General Secretary of COMECE stated that “given that the financial means available for research are limited, EU funding must – in order to spend the available means in the most appropriate manner – concentrate on joint priorities.” This statement was produced in view of the possibility, foreseen under the FP7, of funding research in human embryonic stem cells (hESC), a research that entails the destruction of human embryos. If this was plainly valid in 2006, it is simply incomprehensible that the new programme, Horizon 2020, that has just been adopted by the European Parliament (EP), sticks with that wrong, ethically reproachable approach to research.

A key Programme with a major ethical problem

Horizon 2020 is an EU programme to run from 2014 to 2020 and was proposed in a legislative package of proposals presented by the European Commission on 20 November 2011. As a major instrument for promoting growth through research and innovation in the European Union Horizon 2020 is to be welcomed.

After almost two years and 1824 amendments tabled in the ITRE (Industry, Research and Energy) Committee of the European Parliament, the procedure has finally came to an end. Unfortunately, as regards the ethical framework of the Programme, some shortcomings have to be mentioned; for example, no reference is made to key principles applicable in the field: protection of human dignity and the principle of primacy of the human being – putting the interests and welfare of the human being before that of society or science.

Nevertheless, the major ethical problem of Horizon 2020 is still the possibility of funding research on hESC. On 21 November last, by voting against six amendments which reproduced the Opinion adopted on 18 November 2012 by the JURI (Legal Affairs) Committee, the EP Plenary upheld the common text allowing for such funding as already agreed with the Council in the context of the trilogue negotiations. It is worth saying that JURI is the EP Committee actually competent to analyse the compliance of European Union acts with primary law and for the interpretation of European law and the analysis of ethical questions related to new technologies.

A position grounded on solid reasons

The Secretariat of COMECE has voiced its position against funding such research on many occasions ever since the proposals were published (cf. Press release of 13.09.2012 and Press release of 7.12.2011). In October 2012 the Secretariat welcomed the granting of the Nobel Prize for Medicine for research on alternatives to embryonic stem cells research (cf. Press release of 8.10.2012).  Horizon 2020 as now adopted does not even prioritize funding research in alternative, much more promising research (can we still say that hESC are promising?) on non-ethically problematic sources of stem cells (see Europeinfos no. 140, of July-August 2011), and this is a matter for regret. On the other hand, the text of Horizon 2020 as adopted has not duly taken into consideration the ruling in the case of Greenpeace v. Brüstle, whereby the European Court of Justice reaffirmed the legal protection of the human embryo, defined as any human ovum after fertilisation », and the non-patentability of inventions that make use hESC (see Europeinfos no. 139, of June 2011, and Europeinfos no. 144, of December 2011).

Inconsistency and perplexity

The EP Plenary also adopted an amendment referring to a statement of the European Commission on the ethical framework of Horizon 2020. This statement is very much the same as the one adopted by the Commission in 2006 with regard to FP7, so the status quo as concerns funding research on hESC is basically maintained. By paragraph 12 of the statement now adopted, the Commission commits itself to continue with the current practice» which means that it will not  consider «projects which include research activities which destroy human embryos, including for the procurement of stem cells», making sure however that «the exclusion of funding of this step of research will not prevent Community funding of subsequent steps involving human embryonic stem cells». This is rather inconsistent from an ethical perspective, especially if we bear in mind that such funding of subsequent steps stimulates the procurement of hESC and, thus, escalates human embryo-destructive research. The Secretariat of COMECE has always upheld the exclusion of any research involving the use of hESC including in steps subsequent to their derivation.

Meanwhile, as the European citizens’ initiative One of Us (see Europeinfos no. 150, of June 2012) calls for the EU to stop funding such kinds of research, the reply is much awaited to a Question for written answer asking what measures will the Commission take to ensure that the adoption of Horizon 2020 will not pre-empt such an initiative, the biggest so far with about 1.9 million signatures.

By way of a conclusion to what has been said above, one can say that for ethical reasons, but also in the light of new scientific and legal developments and their impact on the economic rationale of research, it is surely to regret the missed opportunity to take this step forward in the field of EU research policy with regard to stem cells.

terça-feira, 3 de dezembro de 2013

Where Do (Modern) Babies Come From? - by Alana S. Newman

In The Public Discourse

“Eggsploitation” reveals the predatory practices of the fertility industry, which lures young women in need of money to undergo medical procedures that carry the risk of severe long-term health problems.

In 2000, a California nurse named Jennifer Lahl founded a nonprofit in the East Bay called The Center for Bioethics and Culture Network. CBCN is dedicated to educating the public about the troubling bioethical issues unfolding in the modern medical field.

Although she had no previous experience in filmmaking, Lahl managed to raise some money and set out to create a documentary. The resulting film, Lines That Divide, explored the stem-cell research debate, highlighting its terrifying connection to human cloning, and revealing how it required vast quantities of human eggs in order for the research to progress. As she began to write and speak publicly about egg donation and its risks, Lahl started to receive emails from women who had been harmed by selling their eggs.

Concerned for her three daughters, and for all young women, she began work on her second documentary Eggsploitation, which was originally released in 2010. Eggsploitation captured the attention of women’s advocacy groups around the country, including the National Organization for Women. It was the first film to shine light on the predatory nature of the fertility industry and its exploitation of college-aged women. It gave a voice to women who were lured by money and ended up sacrificing their health, fertility, and—in some cases—their very lives.

The original film had a low budget and was clearly the product of a nurse on a mission, not an experienced filmmaker. But, like a Bob Dylan song, the film’s powerful content broke through any aesthetic weaknesses, and it won Best Documentary in the 2011 California Independent Film Festival. So far, it has sold over 6,000 copies worldwide, with translations in Italian, French, and Japanese. Lahl has become an effective public advocate, making a huge impact and appearing on national TV shows such as Dr. Oz.

In the last three years, young women have poured out their stories, affirming Eggsploitation’s thesis that egg donation harms healthy young women. If you visit the film’s website you can read interviews with women like Y, who became infertile at 28 and suspects that her early menopause was caused by her egg harvesting, or Americus Dotter, who shares her frightening experience with postpartum psychosis.

In fact, so many more women came forward with their stories and concerns that Lahl felt she had to compile a second cut of Eggsploitation. The expanded film features new stories and updated facts and footage that show the unadvertised power dynamics and big money involved in this industry. The production value of the new Eggsploitation has dramatically improved. The cast is comprised of both familiar and new interviewees. The audience gets a helpful history of IVF, including its startling failure rate (70 percent) and price tags ($12,000+ per cycle).

The human stories are the heart of the documentary, and the egg donors in the film are given the compassion and generosity they deserve. Yet respect for scientific research and medical facts is equally central. It is this combination, undoubtedly a byproduct of Lahl’s decades of experience as both a nurse and a mom, that makes the documentary so extraordinarily compelling.

“Egg donors are not sick, yet they assume all the risk in order to help someone else.” –Jennifer Lahl

Kylee and Calla, two egg donors interviewed in the documentary, suffered strokes as a direct result of their egg harvesting. Alexandra lost an ovary and eventually developed breast cancer (a condition which does not run in her family). Sindy almost bled to death. Linda and Latoya were hospitalized with Ovarian Hyper-Stimulation Syndrome. And Jessica was diagnosed with colon cancer at age 29, then died at 34.

One of the primary drugs used in egg harvesting is Lupron–which has never been approved by the FDA for fertility use. And in the thirty years the human egg trade has existed, there has never been one peer-reviewed study confirming that egg harvesting is safe long-term.

“Economic desperation causes healthy women to accept risks that are against their own health interests.” –Jennifer Lahl

The elite and wealthy who hope to further science or become parents may assume that these women undergo such invasive treatments altruistically, because $8,000 is an inconsequential sum to them. But a few thousand dollars can mean the world to a broke and ambitious young woman. It’s a needle-length journey into a whole new class—through a college degree, the “right” address, or travel experience.

The exchange of money is problematic because the commissioning parents may feel entitled to mistreat and use the egg donor as just another service-provider. And it is problematic to the donor, in particular, because she risks her health in exchange for money. But money can’t buy back her health once it’s gone. This is why we don’t sell organs. It threatens human thriving.

Leah Campbell, a former egg donor, wrote a book called Single Infertile Female: Adventures in Love, Life and Infertility detailing her inability to conceive and her struggles with IVF just two years after selling her eggs. Speaking publicly at a recent event, Campbell said that when she told the clinic about her infertility—probably caused by her egg donation—they delightfully offered to connect her with a similarly unsuspecting young egg donor to aid in her now-desperate efforts to have a baby of her own. They were happy to have her back as a customer.

The infertility industry works hard to recruit “smart” egg donors, because good grades and name-brand colleges sell better. But when those same young women use their intelligence to ask questions about proper dosages and try to advocate for their own health, their concerns are dismissed or ignored entirely. They are pressured to continue painful cycles against their intuition in order to have a successful harvest, because medicine wasted is money wasted.

I remember when I was twenty and sold my eggs.
That $8,000 seemed like the gateway to millions more. I had never seen that much money, and it seemed like the answer to all of my heart’s desires. I was small and compliant as I interviewed with the agency personnel. I didn’t want to make a fuss or be difficult in any way, because my eye was on the check. My only act of defiance was insisting on being open for contact if the children ever wanted to know my identity.

During the week of the egg harvest, my body cavity was as dense and inflexible as the trunk of an oak. I couldn’t so much as lightly jog due to the pain. I used part of the money to record my first EP—my musical debut. In the recording studio, I made my sound engineer uncomfortable as I writhed on the floor in pain, unable to sit in a chair for the pressure I felt in my abdomen. But I’m one of the lucky ones. I was still able to have children later when I met my husband.

But beyond the temporary physical pain, there is a guilt that lingers: the realization that I sold my children. To strangers. It’s a reasonable conclusion to come to when you start to unravel the euphemisms.

Eggsploitation is just what the doctor ordered—or fears, rather—in the debate on reproductive technologies and stem-cell research. Show it to every college-aged woman you care for. And if you’re trying to make a case against third-party reproduction to an audience you think might be antagonistic, this powerful documentary is the perfect place to start.

quarta-feira, 11 de setembro de 2013

On Melting Snowflakes and Saving Babies: The State of the Question - by Dr. Jeff Mirus

In CC


The debate continues on the morality of embryo adoption, often called the adoption of “snowflake babies”. What is at issue here is whether it is moral to transfer a frozen embryo created through some other procedure into the uterus of a woman who is willing to carry the child to term and give birth in order to save that child’s life. Recently, for example, Joseph Mazzara argued on Catholic Stand that such an embryo transfer is immoral (see Snowflake Babies: Don’t Melt Them). This reminds me that the issue is still troubling to Catholics who try hard to think with the Church.

Mazzara is to be commended for his effort to explore a difficult question, but the particular arguments he used in this instance will not stand close examination. As some others have also done, he attempted to show that the 1987 instruction of the Congregation for the Doctrine of the Faith, Donum Vitae, teaches that embryo transfer is intrinsically immoral. But the obvious rejoinder (as we will see) is that this is not what the document says.

Pressed on this point in the ensuing discussion, Mazzara seemed to retreat into a rhetorical question: How can a woman become pregnant with another man’s child without having, in effect, committed some form of adultery? But this question (as at least one critic pointed out) assumes what it hopes to prove, for the obvious response is that a woman can become pregnant without being adulterous precisely through embryo transfer. Embryo transfer cannot be pre-defined as involving the sin of adultery because the fact of pregnancy has no bearing on the sinfulness of adultery. While pregnancy with another man’s child, in the usual course of things, is evidence of adultery, the sin of adultery does not consist in pregnancy at all, but in engaging with another in what is supposed to be a conjugal or marital act, with its implications of complete self-giving, of lifelong fidelity and commitment to one’s spouse. Pregnancy may or may not be a consequence and, if so, it may be regarded as either fortunate or unfortunate. But it has nothing to do with the intrinsic immorality of adultery.
Clearly it is necessary to go back a step, back to the text itself.

Understanding a Poor Argument

What Mazzara and many others believe is a conclusive magisterial argument against embryo transfer is drawn—through an unfortunate misunderstanding of what the text actually says—from Donum Vitae in Section II, B, 5, “Is Homologous In Vitro Fertilization Morally Licit”. In this section, “IVF” stands for “in vitro fertilization” and “ET” stands for “embryo transfer”. The two are repeatedly linked together as “IVF and ET” because, obviously, the nature of the entire procedure is first to fertilize the egg in vitro and then to transfer the resulting embryo into the body of the woman. This coupling is what has apparently caused some commentators to mistake the meaning of the text.

The section in question considers the “homologous” case (that is, the case in which the egg and sperm have been taken from the married couple involved in the embryo transfer, so that the woman carrying the baby is its biological mother, and the man to whom she is married is the biological father). Further, the text assesses the morality of the process in and of itself, that is, not based upon the question of whether other embryos have been destroyed in the process. Thus it is as close as we come magisterially to an evaluation of the intrinsic morality of the “IVF and ET” technique, abstracting from questions of parentage, abortion, and even masturbation. The most relevant passage is this:

the so-called “simple case,” i.e., a homologous IVF and ET procedure that is free of any compromise with the abortive practice of destroying embryos and with masturbation, remains a technique which is morally illicit because it deprives human procreation of the dignity which is proper and connatural to it.
So IVF and ET taken together are immoral; that much is clear. But why is this technique morally illicit? Where is the moral fault located? Every time Donum Vitae explains its conclusion it gives exactly the same reason. For example, this explanation immediately follows the judgment quoted above:

Certainly, homologous IVF and ET fertilization is not marked by all that ethical negativity found in extra-conjugal procreation; the family and marriage continue to constitute the setting for the birth and upbringing of the children. Nevertheless, in conformity with the traditional doctrine relating to the goods of marriage and the dignity of the person, the Church remains opposed from the moral point of view to homologous in vitro fertilization. Such fertilization is in itself illicit and in opposition to the dignity of procreation and of the conjugal union, even when everything is done to avoid the death of the human embryo.

In other words, the only thing that the Church has judged intrinsically immoral in the “IVF and ET” technique is the “IVF” part of it, the artificial process of fertilization. This is because, as the Church has explained in several documents, the creation of new life is intended by God to be effected through His participation in the conjugal act, which is the proper expression of the committed love characteristic of the spouses and of the family for which they will care. Creation of a new person by any other means becomes a process of technological manufacture, which inescapably tends to make the child an object, over the very existence of which the parents assume total control. Such an approach undermines the essential respect and even reverence which is always due to the human person.

The “ET” portion of “IVF and ET” is never separately considered in Donum Vitae. The question of whether “ET” is morally licit to save the life of a child who has already been illicitly conceived is neither answered nor even envisioned in this document.

Current State of the Question

In a more recent document issued by the CDF in 2008, Dignitas Personae, the question of embryo transfer is mentioned (the expression used is actually “a form of ‘prenatal adoption’”) but remains essentially unchanged. In fact, at the presentation of the document Archbishop Rino Fisichella stated that embryo adoption was still an open question. If this is true—and a strict reading of the text does support his conclusion—then what is the present state of the question?

First, let me state my own opinion (and it is just that, my opinion at present). I would argue that embryo transfer is not intrinsically immoral, and so its morality must be determined by extrinsic factors, including the intention. Think, for example, of the possibility of removing a naturally-conceived embryo from its mother’s womb in order to correct a severe medical problem which would otherwise kill the baby, and then putting it back when the successful medical intervention is completed. Approving embryo transfer in this case, of course, would not mean it would be moral in adoptive cases. But these questions remain to be resolved. In suggesting that embryo transfer is not intrinsically immoral, I am in agreement with Janet Smith, a renowned orthodox Catholic moralist who holds the Father Michael J. McGivney Chair of Life Ethics at the Sacred Heart Major Seminary in Detroit—though, as befits an open question, Dr. Smith acknowledges that some other moralists who are equally committed to orthodoxy disagree with her (see, for example, Adopting Embryos: Why Not?, which was written in March of 2009; there have been no magisterial clarifications since).
My own opinion notwithstanding, the Magisterial state of the question very clearly suggests caution, so much so that those who view embryo transfer as immoral under all circumstances have some grounds for thinking they have at least chosen the higher and safer ground. This is evident from the following three statements:

  1. In Donum Vitae (1987): “In consequence of the fact that they have been produced in vitro, those embryos which are not transferred into the body of the mother and are called ‘spare’ are exposed to an absurd fate, with no possibility of their being offered safe means of survival which can be licitly pursued.” Caveat: In 1987, of course, this could simply mean that no licit option had then been suggested. Again, the document gives no evidence of any awareness of the possibility of embryo transfer to save the life of the child.
  2. By John Paul II in an address to a 1996 Symposium on Evangelium Vitae and Law: “[I] appeal to the conscience of the world’s scientific authorities and in particular to doctors, that the production of human embryos be halted, taking into account that there seems to be no morally licit solution regarding the human destiny of the thousands and thousands of ‘frozen’ embryos which are and remain the subjects of essential rights and should therefore be protected by law as human persons”. Caveats: Here the statement is not Magisterial; moreover, even if embryo adoption were licit, it would be unlikely to resolve the problem posed by the production of huge numbers of human embryos; finally, the Pope’s use of the word “seems” is telling.
  3. In Dignitas Personae (2008): “It has also been proposed, solely in order to allow human beings to be born who are otherwise condemned to destruction, that there could be a form of ‘prenatal adoption’. This proposal, praiseworthy with regard to the intention of respecting and defending human life, presents however various problems not dissimilar to those mentioned above” (19). Here we have the first Magisterial comment on embryo adoption specifically. Caveat 1: The problems alluded to could relate to embryo transfer intrinsically, to the morality of surrogate motherhood, to the connection of the adoptive woman to the immoral process by which the embryo came into existence, or to the false impression that embryo transfer somehow legitimates the production of embryos. The section immediately concludes by repeating the Church’s statement of difficulty: “All things considered, it needs to be recognized that the thousands of abandoned embryos represent a situation of injustice which in fact cannot be resolved” (19). Caveat 2: But again, this would be true even if embryo adoption were ultimately determined to be licit, not least because of the sheer numbers involved.

Thus there are clear grounds for caution in Dignitas Personae, but the strict attention to what is enjoined and prohibited in properly understanding a magisterial text does not preclude the possibility that the Church will in the future resolve her moral concerns in favor of embryo adoption to save the life of the child, thereby affording at least a partial solution to an untenable situation.

This, then, is the state of the question. Embryo transfer presents problems similar enough to actions already determined to be immoral as to preclude the Church, in her latest treatment of the subject, from endorsing embryo adoption as moral. Even if she did endorse it as moral, it would certainly not be an adequate solution to (let alone provide any excuse for) the immoral production of embryos outside of the marital act. Yet neither has the Church yet concluded that embryo transfer is intrinsically immoral regardless of motive. And that is why the question remains open.

Printers Aren't Just For Homework Anymore: The Science and Ethics of Bioprinting - by Christian Brugger




What do you get when you combine the technology of inkjet printers, digital modeling, and 3-D manufacturing?  Right.  3-D printers. 
Okay, that was easy.  Now add living tissues to the mix. 

Very funny.  But no… not an Obama bobble head with human hair.

The real answer?  Three-dimensional cellular construction, also known as 3-D bioprinting.
Standard 3-D printers have been around since the 1980s.  Guided by a three-dimensional computer image, the printer-head lays down successive layers of a material such as plastic in the form of an image, say, the Eifel Tower.  The outcome is a precisely-fashioned plastic model of the thing imaged. 

In the last ten years, the technology has become quite common in fields such as dental, automotive and aerospace engineering, architecture, as well as in the design of footwear, jewelry, eyewear, etc.

Printing Human Tissues
Scientists in the field of regenerative medicine conceived the idea of using 3-D printing technology to produce—to print—human tissues and organs.  Rather than layers of plastic, bioprinters set down layer upon layer of biomaterials such as living cells, which are built up into three-dimensional structures.  The technology is at various stages of development, most still at the research phase.

What’s “the ink”?  Most techniques use induced Pluripotent Stem (iPS) cells, the revolutionary technology that we’ve covered in these pages several times over the last few years.  The iPS cells are usually derived from healthy tissue samples taken from would-be transplant recipients.

One example of the new technique is skin printing, which researchers hope will improve graft treatments for burn victims.  It involves printing sheets of iPS cells derived from healthy skin samples from burn victims.  The cells grow and differentiate into the different layers of skin and then can be transplanted.  In some cases, the skin cells are printed directly onto a victim’s wound.

At Cornell University, experimental heart valves and knee cartilage have been printed; at Wake Forest, functional kidney cells; and at the University of Missouri-Columbia, sheets of beating heart muscle.

Bio-scaffolding

Even more innovative is the technique of bio-scaffolding to create larger organs, for example, new bones for bone replacement surgery.  A digital image of a segment of bone is developed from a bone injury patient.  From that image, a three-dimensional bone scaffold identical to the segment is “printed out” using artificial materials.  The scaffold is then coated with stem cells derived from the patient’s own body.  The printed bone structure is then transferred into the patient, where, over time, the artificial scaffold harmlessly degrades, leaving behind new bone grown from the patient’s own stem cells.
Scaffolding technology has already been used to create replacement tracheas, blood vessels and bladders for use in surgical transplants (watch this interesting video). Researchers at the University of Louisville predict that within ten years, bioprinting will be used to create fully-functioning “bioficial” human hearts.
Ethical Considerations
What ethical questions are raised by the new technology?  The first concerns the sources of stem cells used in a given technique.  Although most bioprinting protocols use iPS cells, not all do.  Some use adult stem cells, which are morally legitimate.  But others use stem cells derived from destroying human embryos.  This is the case, for example, with research at Heriot-Watt University in Edinburgh, Scotland, where researchers have developed a bioprinter that uses human embryonic stem cells as its “ink.” 
Safety concerns are also important to consider.  The urgent need for transplantable organs mustn’t move us to cut corners in clinical safety trials with this new generation of “bioficial” products.
We also have reasons to be concerned about researchers stretching towards unethical boundaries; for example, if they were to begin coveting the forbidden fruit of producing whole brains for purposes of transplanting them into humans. 
I do not mean to stigmatize research into the repair and regeneration of damaged neurological tissue.  I have family members with Alzheimer’s disease and would welcome (they would welcome!) therapeutic treatment options for overcoming the crippling condition. 
But whole brain transplants?  Even if they were ever possible utilizing brain matter derived from one’s own stem cells, which is doubtful, they would so impact a person’s personality and conscious identity (loss of memory, character, psychological development, brain-body history) that in all but the most narrow of circumstances I don’t see how they could be ethically licit.  (Perhaps in fetuses with severe traumatic brain injury; but only perhaps.)
Not all agree.  Just last week, the Promethian juices of scientists were stimulated when the journal Nature announced that “mini-brains” had been produced in vitro for the first time. 
Austrian researchers grew stem cells upon a gel that resembled some of the brain’s natural connective tissues.  The cells developed into neural tissue clumps that when infused with nutrients and oxygen began to interact in ways characteristic of fetal brains in the early weeks of human development. 
One enthusiastic scientist interviewed for the article (and not involved in the study) proclaimed: “It’s a seminal study to making a brain in a dish!”  But, he continued, a “fully formed artificial brain might still be years away.”  Phew!  I guess we don’t need to worry.
Defend Our Ethical Boundaries

This new technology, especially the scaffolding method, puts us in reach within a decade of the elusive goal of achieving a surplus of transplantable organs for those who need them.  And it seems that the goal can be achieved through morally licit forms of research. 
This is unbelievable.
Ten years ago scientists were arguing that this was only possible if we “relaxed” our morality: “give us embryos,” they cried, “otherwise people will die;” or if not embryos, then at least suspend the “dead-donor rule” for vital organ donation. 
The amoralists were proven wrong; iPS cell research and adult stem cell research now dominate the field of regenerative medicine.
But the amoralists haven’t gone away.  Even in the face of the staggering failure of embryonic stem cell research, they’re still clamoring for human embryos, though not as loudly.  And more and more are advocating for the abandonment of the dead-donor rule in transplant medicine.
We mustn’t lose hope that reason will prevail over lust in the field of regenerative medicine.  Where scientific genius is guided by good morals, remarkably good things can happen.  Shinya Yamanaka’s breakthrough with iPS cells in 2007 is merely the most recent example.