sábado, 29 de abril de 2017

BioEdge: Recreating the womb for preemies

BioEdge: Recreating the womb for preemies

Saturday, April 29, 2017



Recreating the womb for preemies
     


Researchers have moved a step closer to ectogenesis – brewing babies in an artificial womb. A team at the Center for Fetal Research in Philadelphia have developed a womb-like environment in which premature lambs have already lived at least four weeks before being delivered.

A similar system for babies is at least two years off, but if it is successful, it would give the tiniest newborns a precious few weeks to develop their lungs and other organs.

The fetal lambs grow in a temperature-controlled, near-sterile environment, breathing amniotic fluid as they normally do in the womb, their hearts pumping blood through their umbilical cord into a gas exchange machine outside the bag.

Of the one in ten US births that are premature (younger than 37 weeks gestational age), about 30,000 per year are critically preterm -- younger than 26 weeks. Extreme prematurity is the nation's leading cause of infant mortality and morbidity, accounting for one-third of all infant deaths and one-half of all cases of cerebral palsy attributed to prematurity.

Neonatal care practices have improved overall survival of premature infants and have pushed the limits of viability to 22 to 23 weeks of gestation. At that age an infant weighs below 600 grams -- little more than a pound -- and has a 30 to 50% chance of survival. But this survival comes at a high price in quality of life, with a 90% risk of morbidity, from chronic lung disease or other complications of organ immaturity. Survivors face lifelong disability.

Previous researchers have investigated versions of an artificial placenta in animal models, but pumpless systems have achieved a maximum duration of 60 hours, and the animals have sustained brain damage. The new system, in contrast, has operated up to 670 hours (28 days) with some animals, which remained healthy. The lambs showed normal breathing and swallowing, opened their eyes, grew wool, became more active, and had normal growth, neurological function and organ maturation.

The team does not aim to extend viability to an earlier period than the current mark of 23 weeks. Before that point, limitations of physical size and physiologic functioning would impose unacceptably high risks.

The development of an artificial womb will inevitably be linked to the abortion debate. Reasoning that babies could survive after 20 weeks, some legislators might try to ban abortions after 20 weeks of gestation. And if it became a viable alternative, the meaning of abortion changes. As Peter Singer wrote with Deane Wells in 1985 in The Reproductive Revolution, “Freedom to choose what is to happen to one’s body is one thing; freedom to insist on the death of a being that is capable of living outside of one’s body is another.”


Bioedge

Saturday, April 29, 2017

The Belgian media was abuzz this week with the news that the Catholic hospitals which provide a substantial portion of psychiatric beds will permit euthanasia for non-terminally-ill patients. It is an unprecedented reversal of their stand on end-of-life care.
Supporters of euthanasia, of course, were delighted. “The last relics of the paternalism of the shepherd have been replaced by individual self-determination," said one politician. Opponents, however, were puzzled and alarmed. Fifteen years after Belgium legalised euthanasia, it has become hard to find a hospital where is it not being practised. Read about it below. 


Michael Cook
Editor
BioEdge

NEWS THIS WEEK
 
by Michael Cook | Apr 29, 2017
From now on it will be difficult to find a psychiatric hospital where euthanasia is not offered
 
by Michael Cook | Apr 29, 2017
US researchers are close to an artificial womb for extremely premature babies
 
by Michael Cook | Apr 29, 2017
Life expectancy has risen steeply
 
by Michael Cook | Apr 29, 2017
Why should they settle for anything less than heterosexual couples?
 
by Michael Cook | Apr 29, 2017
There was no lack of ethical training in the Nazi era
 
by Paul Russell | Apr 27, 2017
Ezekiel Emanuel says that pain is not the the reason people ask doctors to end their lives
 
by Michael Cook | Apr 26, 2017
Ellinor Grimmark has had to move to Norway to find work
BioEdge
Suite 12A, Level 2 | 5 George St | North Strathfield NSW 2137 | Australia
Phone: +61 2 8005 8605
Mobile: 0422-691-615
New Media Foundation | Level 2, 5 George St | North Strathfield NSW 2137 | AUSTRALIA | +61 2 8005 8605 

BioEdge: Counting Down syndrome Americans

BioEdge: Counting Down syndrome Americans

Saturday, April 29, 2017



Counting Down syndrome Americans
     


Down syndrome is the leading cause of intellectual disability in the United States. But how many Americans have Down syndrome? There is no clear answer to that question, as the US does not record this information systematically.

Brian Skotko, of Harvard Medical School, and colleagues have done a statistical analysis of Down syndrome Americans in the journal Genetics in Medicine and come up with some very interesting statistics.

The number has quadrupled in the last 60 years because people with DS have a much higher life expectancy.

“We estimate that the number of people with DS living in the United States has grown from 49,923 in 1950 to 206,366 in 2010, which includes 138,019 non-Hispanic whites, 27,141 non-Hispanic blacks, 32,933 Hispanics, 6,747 Asians/Pacific Islanders, and 1,527 American Indians/American Natives. Population prevalence of DS in the United States, as of 2010, was estimated at 6.7 per 10,000 inhabitants (or 1 in 1,499).”
The impact of abortion is substantial:

“In the absence of elective terminations, these predicted numbers would have been 245,981, including 167,992 NHW, 31,836 NHB, 33,620 HIS, 10,716 AS/PI, and 1,817 AI/AN. This corresponds with reductions in population prevalence related to elective terminations, which are estimated to be 19% for all people with DS, 19% for NHW, 16% for NHB, 13% for HIS, 47% for AS/PI, and 16% for AI/AN.”
The impact of abortion is even higher in the UK:

“In the United States, in 1995, there were an estimated 8% fewer people with DS than there would have been without elective terminations, and this value increased to approximately 19% in 2010. In the United Kingdom, the corresponding estimated values were 10 and 26%, respectively.”
Down syndrome people are living much longer. In the US, Down syndrome is no longer a childhood disability:

“According to our model, the mean and median age of death also increased, and even more rapidly, from an estimated 3 and 0 years, respectively, in 1950 to 12 and 2 years in 1970 to 35 and 38 years in 1990 to 48 and 54 years in 2010.”


Bioedge

Saturday, April 29, 2017

The Belgian media was abuzz this week with the news that the Catholic hospitals which provide a substantial portion of psychiatric beds will permit euthanasia for non-terminally-ill patients. It is an unprecedented reversal of their stand on end-of-life care.
Supporters of euthanasia, of course, were delighted. “The last relics of the paternalism of the shepherd have been replaced by individual self-determination," said one politician. Opponents, however, were puzzled and alarmed. Fifteen years after Belgium legalised euthanasia, it has become hard to find a hospital where is it not being practised. Read about it below. 


Michael Cook
Editor
BioEdge

NEWS THIS WEEK
 
by Michael Cook | Apr 29, 2017
From now on it will be difficult to find a psychiatric hospital where euthanasia is not offered
 
by Michael Cook | Apr 29, 2017
US researchers are close to an artificial womb for extremely premature babies
 
by Michael Cook | Apr 29, 2017
Life expectancy has risen steeply
 
by Michael Cook | Apr 29, 2017
Why should they settle for anything less than heterosexual couples?
 
by Michael Cook | Apr 29, 2017
There was no lack of ethical training in the Nazi era
 
by Paul Russell | Apr 27, 2017
Ezekiel Emanuel says that pain is not the the reason people ask doctors to end their lives
 
by Michael Cook | Apr 26, 2017
Ellinor Grimmark has had to move to Norway to find work
BioEdge
Suite 12A, Level 2 | 5 George St | North Strathfield NSW 2137 | Australia
Phone: +61 2 8005 8605
Mobile: 0422-691-615
New Media Foundation | Level 2, 5 George St | North Strathfield NSW 2137 | AUSTRALIA | +61 2 8005 8605 

BioEdge: Counting Down syndrome Americans

BioEdge: Euthanasia is a ‘sideshow’ in end-of-life care, says leading US bioethicist

BioEdge: Euthanasia is a ‘sideshow’ in end-of-life care, says leading US bioethicist

Saturday, April 29, 2017



Euthanasia is a ‘sideshow’ in end-of-life care, says leading US bioethicist
     


The Medical Journal of Australia has just published a commissioned paper on euthanasia and assisted suicide by one of America’s leading bioethicists, Dr Ezekiel Emanuel. Emanuel is not a palaeo-conservative. A brother of Obama’s former chief-of-staff, Rahm Emanuel, a fellow at the Center for American Progress, and a professor at the University of Pennsylvania, his liberal credentials are impeccable. However, he regards euthanasia as a “side-show” in the vital discussion of end-of-life care.

Emanuel cites the data from places where euthanasia and physician-assisted suicide (PAS) are legal and notes that premature death by the methods employed are rare. While rarity is a matter of degree and interpretation, it is true to say that the vast majority of people do not seek to access premature death. Emanuel concludes:

"These data mean that the claim that legalising euthanasia and PAS will help solve the problem of poor end-of-life care is erroneous. Euthanasia and PAS do not solve the problem of inadequate symptom management or improving palliative care. These interventions are for the 1% not the 99% of dying patients. We still need to deal with the problem that confronts most dying patients: how to get optimal symptom relief, and how to avoid the hospital and stay at home in the final weeks.

“Legalising euthanasia and PAS is really a sideshow in end-of-life care — championed by the few for the few, extensively covered by the media, but not targeted to improve the care for most dying patients who still suffer."
It's not about pain

The public perception of the justification for E & AS seems to be largely focussed on pain. The word “suffering” is extends to “existential”' issues. But existential suffering - like pain itself, is well managed by good care. In any case, it remains the case that the drivers of euthanasia argument and understanding in the community is about a supposedly compassionate response to pain experienced by people with difficult and demanding prognoses.

Emanuel debunks this myth by reference to the data:

"Second, pain is not the primary reason why people seek euthanasia or PAS. It is commonly thought that patients in excruciating and unremitting pain would want these interventions. Many healthy people believe that pain would be the reason why they may want them; however, evidence suggests otherwise. Patients who request and receive euthanasia or PAS infrequently experience pain; similarly, few patients in pain actually want euthanasia or PAS.

Two decades ago, research with patients who had cancer or HIV showed that those who were interested in euthanasia or PAS were not those experiencing pain. This has been confirmed multiple times; for instance, the data from the state of Oregon in the US, which has followed patients who have requested and used PAS for 17 years now, show that fewer than 33% of patients are experiencing — or fearing — inadequate pain control. Even in Australia, when for a brief moment seven patients were given euthanasia in the Northern Territory, none had uncontrolled pain.

"If not pain, then what motivates patients to request euthanasia and PAS? Depression, hopelessness, being tired of life, loss of control and loss of dignity. These reasons are psychological — they are clearly not physical pain — and are not relieved by increasing the dose of morphine, but by antidepressants and therapy. In the states of Oregon and Washington, the reasons for wanting PAS were: 90% of patients reported loss of autonomy, 90% were less able to engage in activities that make life enjoyable and 70% declared loss of dignity — depression and hopelessness are not listed and are not included in the reporting list. Likewise, in the Netherlands, the main legal requirement is “extreme physical or mental suffering,” and patients’ reasons are classified in this manner, making it hard to know whether the reasons are physical symptoms of depression.

However, when researchers from the Netherlands — who were convinced that the main rationale was pain — interviewed patients who requested euthanasia, they found that few of the ones using euthanasia were experiencing pain, but most were depressed".
He moves on to discuss psychological suffering which, generally speaking, would include a great deal of that which is claimed to be existential:

"The importance of psychological suffering as patients’ rationale for requesting euthanasia and PAS indicates that these interventions are less like palliative care and more like traditional suicide condoned and assisted by the medical community. The main drivers of traditional suicide are psychological problems. Despite the importance of psychological suffering as the main motivator, few physicians in the jurisdictions where euthanasia and PAS are legal receive psychiatric consultation.

Indeed, in the states of Oregon and Washington, less than 4% of patients who had PAS had a psychiatric consultation. In Belgium, where an independent physician needs to be consulted for non-terminal cases, in 42–78% of cases that physician is a psychiatrist. Since psychological reasons dominate, one would think that requiring psychiatric evaluation would be a reasonable safeguard before providing euthanasia or PAS. Therefore, we need to think very differently about what drives people to want euthanasia. The picture most people have of patients who are writhing in uncontrolled pain despite morphine is simply wrong." (emphasis added)
A painless exit?

The marketing and sloganeering of the pro euthanasia and assisted suicide brigade would have us believe that the provision of a premature death by way of a lethal dose is “dignified” because it is quick and painless. The likes of Exit International and Philip Nitschke going so far as to market products and methods under the slogan, the “peaceful pill”. This is false and ignores the reality, as Emanuel points out:

"Third, many people believe euthanasia and PAS are flawless, quick and painless. This belief is common but mistaken. No medical procedure — even simple ones like blood draws — is flawless; every medical procedure has problems and complications. Euthanasia and PAS are no exceptions.

According to a study in the Netherlands from 2000, 5.5% of all cases of euthanasia and PAS had a technical problem and 3.7% had a complication. An additional 6.9% of cases had problems with completing euthanasia or PAS. Technical problems, including difficulty finding a vein and administering oral medications, occurred in 4.5% of euthanasia cases and in 9.8% of PAS cases. Moreover, 3.7% of euthanasia cases and 8.8% of PAS cases had complications, such as nausea, vomiting and muscle spasms. Overall, an additional 1.1% of patients who had euthanasia or PAS did not die but awoke from coma. The data suggest that the common view of euthanasia and PAS as quick, flawless, and painless ways to die is unrealistic." (emphasis added)
In conclusion, Emanuel questions the entire thrust towards patient killing and patient suicide:

"When considering this evidence, the case for legalising euthanasia and PAS looks less compelling. They will not improve the care of many dying patients, they are not helping people in pain and enduring inadequately treated physical symptoms, and are far from quick and flawless. What is then the great impetus to legalise interventions to end lives for a small minority of patients who are depressed, worried about losing autonomy and being tired of life?

"We should end the focus on the media frenzy about euthanasia and PAS as if it were the panacea to improving end-of-life care. Instead, we need to focus on improving the care of most of the patients who are dying and need optimal symptom management at home."
If Emanuel is right that we should “end the focus on the media frenzy” then it would seem to be an imperative that the media, in turn, report on his observations. Yet, in Australia, this paper was noted only once in the daily papers and only twice in brief news articles on line.

Paul Russell is director of HOPE: preventing euthanasia & assisted suicide, which is based in Australia. This article has been edited and republished from his blog with permission.


Bioedge

Saturday, April 29, 2017

The Belgian media was abuzz this week with the news that the Catholic hospitals which provide a substantial portion of psychiatric beds will permit euthanasia for non-terminally-ill patients. It is an unprecedented reversal of their stand on end-of-life care.
Supporters of euthanasia, of course, were delighted. “The last relics of the paternalism of the shepherd have been replaced by individual self-determination," said one politician. Opponents, however, were puzzled and alarmed. Fifteen years after Belgium legalised euthanasia, it has become hard to find a hospital where is it not being practised. Read about it below. 


Michael Cook
Editor
BioEdge

NEWS THIS WEEK
 
by Michael Cook | Apr 29, 2017
From now on it will be difficult to find a psychiatric hospital where euthanasia is not offered
 
by Michael Cook | Apr 29, 2017
US researchers are close to an artificial womb for extremely premature babies
 
by Michael Cook | Apr 29, 2017
Life expectancy has risen steeply
 
by Michael Cook | Apr 29, 2017
Why should they settle for anything less than heterosexual couples?
 
by Michael Cook | Apr 29, 2017
There was no lack of ethical training in the Nazi era
 
by Paul Russell | Apr 27, 2017
Ezekiel Emanuel says that pain is not the the reason people ask doctors to end their lives
 
by Michael Cook | Apr 26, 2017
Ellinor Grimmark has had to move to Norway to find work
BioEdge
Suite 12A, Level 2 | 5 George St | North Strathfield NSW 2137 | Australia
Phone: +61 2 8005 8605
Mobile: 0422-691-615
New Media Foundation | Level 2, 5 George St | North Strathfield NSW 2137 | AUSTRALIA | +61 2 8005 8605 

BioEdge: Euthanasia is a ‘sideshow’ in end-of-life care, says leading US bioethicist

BioEdge: Swedish midwife opposed to abortion appeals to European Court of Human Rights

BioEdge: Swedish midwife opposed to abortion appeals to European Court of Human Rights

Saturday, April 29, 2017



Swedish midwife opposed to abortion appeals to European Court of Human Rights
     
Ellinor Grimmark speaking to the press    
Swedish midwife Ellinor Grimmark has decided to appeal to the European Court of Human Rights over Sweden’s hard line on conscientious objection.

The Swedish Appeals Court decided earlier this month that the government can force medical professionals to perform and cooperate in abortions, or else be forced out of their profession. Because the ruling in Grimmark v. Landstinget i Jönköpings Län appears to contradict international law protecting conscientious objection, Grimmark wants to appeal to Strasbourg.

Three different medical clinics denied her employment because she will not assist with abortions. In Sweden, midwives are essentially nurses who specialize in pregnancy and child birth and seldom do abortions. It would have been relatively easy to find a way to accommodate Grimmark’s preferences.

However, the clinics’ intransigence has meant that Grimmark and her family have had to move to neighbouring Norway. “In the beginning, I was hoping to stay in Sweden,” she told Fox News. “But we have now made Norway home. I have a job here where they are not concerned with my beliefs.”

In November 2015, a district court found that her right to freedom of conscience had not been violated by refusing to employ her. That court even required her to pay the local government’s legal costs of 100,000 Euros (US$106,000).

“Participation in abortions should not be a requirement for employment as a medical professional. In accordance with international law, the court should have protected Ellinor’s fundamental right to freedom of conscience,” said Robert Clarke, of the Alliance Defending Freedom (ADF International), an American group which is helping with Grimmark’s case.

 “The desire to protect life is what leads many midwives and nurses to enter the medical profession in the first place,” Clarke said. “Instead of forcing desperately needed midwives out of their profession, governments should safeguard the moral convictions of medical staff. The Parliamentary Assembly of the Council of Europe has affirmed that ‘no person, hospital or institution shall be coerced, held liable, or discriminated against in any manner because of a refusal to perform, accommodate, assist, or submit to an abortion.’ As a member state, Sweden must be held to its obligation to respect this freedom.”

The shut-up-or-leave approach to conscientious objection in healthcare issues is widely accepted in Sweden. In a recent article in the Journal of Medical Ethics, bioethicist Christian Munthe, of the University of Gothenburg, explains that “No legal right to conscientious refusal for any profession or class of professional tasks exists in Sweden, regardless of the religious or moral background of the objection”. Swedes feel a strong commitment to civic duties and non-discrimination.

However, the “Swedish solution” may be eroding, for two reasons, neither of them related to Grimmark’s complaint.

The first is political. The general council of the Swedish Medical Association recently agreed to work toward a legal right to conscientious refusal to refer patients to clinics offering alternative medicine. The doctors feel that these upstarts should not be included in the healthcare system.

The second is the very real possibility that Sweden may someday legalise euthanasia or assisted suicide. The medical profession opposes this unless the law includes a provision for conscientious objection. So paradoxically, as Munthe points out, at the moment the Swedish solution to conscientious objection both supports abortion and blocks euthanasia.

Michael Cook is editor of MercatorNet. 


Bioedge

Saturday, April 29, 2017

The Belgian media was abuzz this week with the news that the Catholic hospitals which provide a substantial portion of psychiatric beds will permit euthanasia for non-terminally-ill patients. It is an unprecedented reversal of their stand on end-of-life care.
Supporters of euthanasia, of course, were delighted. “The last relics of the paternalism of the shepherd have been replaced by individual self-determination," said one politician. Opponents, however, were puzzled and alarmed. Fifteen years after Belgium legalised euthanasia, it has become hard to find a hospital where is it not being practised. Read about it below. 


Michael Cook
Editor
BioEdge

NEWS THIS WEEK
 
by Michael Cook | Apr 29, 2017
From now on it will be difficult to find a psychiatric hospital where euthanasia is not offered
 
by Michael Cook | Apr 29, 2017
US researchers are close to an artificial womb for extremely premature babies
 
by Michael Cook | Apr 29, 2017
Life expectancy has risen steeply
 
by Michael Cook | Apr 29, 2017
Why should they settle for anything less than heterosexual couples?
 
by Michael Cook | Apr 29, 2017
There was no lack of ethical training in the Nazi era
 
by Paul Russell | Apr 27, 2017
Ezekiel Emanuel says that pain is not the the reason people ask doctors to end their lives
 
by Michael Cook | Apr 26, 2017
Ellinor Grimmark has had to move to Norway to find work
BioEdge
Suite 12A, Level 2 | 5 George St | North Strathfield NSW 2137 | Australia
Phone: +61 2 8005 8605
Mobile: 0422-691-615
New Media Foundation | Level 2, 5 George St | North Strathfield NSW 2137 | AUSTRALIA | +61 2 8005 8605 

BioEdge: Swedish midwife opposed to abortion appeals to European Court of Human Rights

Press Announcements > FDA approves new combination treatment for acute myeloid leukemia

Press Announcements > FDA approves new combination treatment for acute myeloid leukemia

u s food and drug administration

FDA approves new combination treatment for acute myeloid leukemia


The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML.

AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. The National Cancer Institute estimated that approximately 19,930 people would be diagnosed with AML in 2016 and 10,430 were projected to die of the disease.
“Rydapt is the first targeted therapy to treat patients with AML, in combination with chemotherapy,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “The ability to detect the gene mutation with a diagnostic test means doctors can identify specific patients who may benefit from this treatment.”
Rydapt is a kinase inhibitor that works by blocking several enzymes that promote cell growth. If the FLT3 mutation is detected in blood or bone marrow samples using the LeukoStrat CDx FLT3 Mutation Assay, the patient may be eligible for treatment with Rydapt in combination with chemotherapy.
The safety and efficacy of Rydapt for patients with AML were studied in a randomized trial of 717 patients who had not been treated previously for AML. In the trial, patients who received Rydapt in combination with chemotherapy lived longer than patients who received chemotherapy alone, although a specific median survival rate could not be reliably estimated. In addition, patients who received Rydapt in combination with chemotherapy in the trial went longer (median 8.2 months) without certain complications (failure to achieve complete remission within 60 days of starting treatment, progression of leukemia or death) than patients who received chemotherapy alone (median three months).
Common side effects of Rydapt in patients with AML include low levels of white blood cells with fever (febrile neutropenia), nausea, inflammation of the mucous membranes (mucositis), vomiting, headache, spots on the skin due to bleeding (petechiae), musculoskeletal pain, nosebleeds (epistaxis), device-related infection, high blood sugar (hyperglycemia) and upper respiratory tract infection. Rydapt should not be used in patients with hypersensitivity to midostaurin or other ingredients in Rydapt. Women who are pregnant or breastfeeding should not take Rydapt because it may cause harm to a developing fetus or a newborn baby. Patients who experience signs or symptoms of lung damage (pulmonary toxicity) should stop using Rydapt.
Rydapt was also approved today for adults with certain types of rare blood disorders (aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm or mast cell leukemia). Common side effects of Rydapt in these patients include nausea, vomiting, diarrhea, swelling (edema), musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, fever, headache and shortness of breath.
The FDA granted this application Priority ReviewFast Track (for the mastocytosis indication) and Breakthrough Therapy (for the AML indication) designations.
The FDA granted the approval of Rydapt to Novartis Pharmaceuticals Corporation. The FDA granted the approval of the LeukoStrat CDx FLT3 Mutation Assay to Invivoscribe Technologies Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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