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How processing health data has become increasingly problematic – Irish Times

Thursday, August 24th, 2017

Almost four and a half years ago, then minister for health Dr James Reilly ordered the Health Service Executive not to destroy more than one million blood samples taken from newborn children in the Republic between 1984 and 2002.

The heel-prick tests, known as Guthrie tests, are carried out on all babies to screen for genetic conditions.

The decision to destroy the cards with the blood samples on them came after it emerged that those taken before July 1st, 2011, were being retained without consent, and therefore in breach of national and EU data protection law.

The Royal College of Physicians at the time said there was an explosion of molecular genetics every day that was being added to and that the museum piece cards could prove to be even more valuable in the future.

The Irish Heart Foundation, which had campaigned to save the cards, said some 1,400 families that had lost a member through sudden adult death syndrome would, as a result, be able to get a genetic diagnosis to see if they were at risk.

The debate over those cards and the legality of retaining them still rumbles on, as do ethical questions about the privacy of highly sensitive medical data obtained for one purpose and whether it should ever be used for another without the consent of the original subject, in the absence of a legal exemption.

Meanwhile, medical and scientific researchers are closely watching the new EU General Data Protection Regulation (GDPR) and what it might mean for them and their work after it takes effect next May.

While the regulation allows certain exemptions for processing special cateogories of data, including genetic and biometric data, the Irish legislation hasnt been written yet and researchers are waiting to see what it will mean for their work.

In some cases, they are worried about what the new law will mean for historic datasets and longitudinal studies and whether they will have to delete them on the grounds that they will not have the appropriate standards of explicit consent post May 2018 to retain them.

Even in just a few years, the medical, legal, ethical and social dilemmas involved in processing health data, including biological samples obtained from patients or research study volunteers have become vastly more complex.

The ethical issues that arise around areas such as stem cell research, embryo research and reproductive cloning, genome sequencing, gene editing and population-scale biobanks are huge.

Opportunities for uncovering the causes of disease, for resolving fertility issues, for fixing genetic conditions, for treating cancers, are within the grasp of scientists and researchers, but there is still no international consensus on many issues.

Concerns are evolving too in light of new models for funding research, such as venture capital-backed projects where highly sensitive data used for research, and effectively a permanent record, may ultimately end up being used by or sold for profit to companies or other third parties anywhere in the world.

Researchers are still uncertain what exactly the GDPR will mean for them in terms of the exemptions from data protection legislation that will apply to so-called special categories of data including genetic and biometric health data used for research.

At a recent event in Dublin, the Irish Platform for Patients Organisations, Science and Industry (IPPOSI) explored the concerns about data protection, consent and the forthcoming regulation.

IPPOSI chief executive Dr Derick Mitchell told the event: Patients are aware that the altruistic benefit of being involved in research far outweighs the risks, but they do expect that they will be consulted on the use of their data.

He said empowerment of the data owner was fundamental to the forthcoming changes in the law, and the event explored a model of so-called dynamic consent to allow people consent to have their data used for research, possibly allowing broad consent at the outset and opt-outs at a later stage where they did not agree to new uses. The legal jury is still out on whether such a model is even possible.

Dr Mitchell said a national response was required to GDPR and not just for health research.

He hoped that guidance on the question of consent for processing of personal data expected later in the year from the independent body representing all of the EUs national data protection authorities would be a step forward.

But I think the real crux is the code of conduct and each institution in effect will have to develop their own code of conduct as to how they approach data protection from the beginning of projects rather than having it as a kind of tick-box exercise at the end of a project, he said.

Dr Mitchell said the explicit consent referred to in the EU regulation, for example, had very real consequences for the continuation of large-scale population biobanks, for example.

There was also an ethical argument going on as to whether a persons consent could be said to be informed if they ultimately did not know what the research project might ultimately examine.

Prof Jane Grimson, a member of the e-health Ireland committee and a former director of Health Information in the Health Information and Quality Authority, said the potential of health data and research had to be balanced with a patients right to privacy.

Ownership of patient records was critical, she said.

I think the way we are moving now is much more towards electronic health records that will be owned and controlled by the individual. Its their information and they should be in control of who has a right to see information and the information (that is used in research).

Ethics research committees were critical and needed to operate to a very high standard to ensure the trust of people, she added.

Its an absolute minefield but I really think that ethics committees are critical.

Prof Orla Sheils, director of the Trinity Translational Medicine Institute and director of medical ethics at the School of Medicine, TCD, said she believed GDPR would have immediate consequences for data already being processed by researchers. It was a very grey area.

The difficulty with that is that if data has been collected over a long period of time that a person may not want to be reminded of the time that they were ill. Thats the balance you are trying to find there. So the way to get around that is to try to give people enough options up front to decide yes, I want to gift my sample and provided the research thats going to be done is ethical and has been approved, thats okay by me.

Prof Sheils, who sits on the St Jamess and Tallaght hospital research ethics committee, said all research involving humans had to be approved by such a committee.

Its never an ethical issue if the answer is easy, she said.

Like everything else in life, its about finding that happy balance that people are comfortable with, she said.

There is never really a right answer when there is an ethical dilemma. What I always say to students is that you are hoping for the least bad option.

Cathal Ryan said the new EU regulation would bring harmonisation, transparency and accountability to a very dense and complex area. The regulation was very pragmatic and the code of conduct within it would act as a form of self-regulation, with the additional oversight of an independent monitoring body. But he said adequate transparency on data protection in the sector had been lacking.

If there is an erosion of trust, if the health sector doesnt treat an individuals data in the right way, there will be problems.

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Another voice: On gun violence research, California sets an example for the nation – Tampabay.com

Thursday, August 24th, 2017

California has never been reluctant to take the lead on critical issues facing the nation. When federal funding was cut off for embryonic stem cell research, it created its own state program. It adopted standards for vehicle emissions and fuel efficiency that have been emulated by other states, and it has doubled down on a commitment to climate change policy in the face of disinterest, if not outright hostility, from the Trump administration. But perhaps nothing is more welcome than California's decision to advance the science of gun violence prevention with the establishment of the country's first publicly funded research center.

The Firearm Violence Research Center, launched last month at the University of California at Davis with a $5 million appropriation from the state, aims to find effective ways to prevent firearm violence through scientific investigation and understanding. Located at the university's Sacramento campus, the research institute will augment the work of Garen Wintemute, an emergency room physician and nationally recognized expert on the epidemiology of firearm violence who serves as its director.

California's decision to be at the forefront of research on gun violence as a public health issue stands in contrast to the dismal abdication of the federal government. Legislation passed by Congress in 1996 barring the Centers for Disease Control and Prevention from spending any funds "to advocate or promote gun control" made the agency skittish about conducting research. Scientific investigation has been key in devising lifesaving solutions to other public health issues, such as automobile safety and swimming pool safety, so the dearth of research into firearms, a leading cause of death for Americans under the age of 65, is intolerable.

Indeed, it is instructive that the lawmaker who successfully carried the National Rifle Association's water in getting the restrictive rider through Congress eventually came to have a change of heart. The late Jay Dickey, a Republican from Arkansas whose amendment led to the scarcity of gun research, joined forces with Mark Rosenberg, former director of the CDC's National Center for Injury Prevention and Control, to advocate federally funded gun research as well as champion in the face of predictable opposition from the gun lobby the establishment of California's center.

Wintemute stressed that the center is not about validating predetermined political agendas but rather, as he told the Los Angeles Times, "understanding the problem of firearm violence that cuts across pro-gun and anti-gun boundaries." In wanting to confront the problem of gun violence with sound data about causes, consequences and effective solutions, California once again sets a good example.

Another voice: On gun violence research, California sets an example for the nation 08/23/17 [Last modified: Wednesday, August 23, 2017 3:40pm] Photo reprints | Article reprints

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Engagement and Events Officer – The Conversation AU

Tuesday, August 22nd, 2017

Department of Anatomy and NeuroscienceFaculty of Medicine, Dentistry and Health Sciences

Salary: $68,892 - $79,130 p.a. plus 9.5% superannuation

Stem Cells Australia (SCA), is a multi-million dollar research initiative supported by the Australian Research Council and several research institutions across Australia. The Centre for Stem Cell Systems (CSCS) was formed in 2016 to facilitate interdisciplinary collaboration between stem cell researchers in the Parkville Precinct, which encompasses the University and affiliated medical research institutes. Together, SCA and CSCS aim to support and promote high quality stem cell research and lead public discussion about the important ethical, legal and societal issues associated with stem cell science.

The Engagement and Events Officer will help build and deliver an effective communications and engagement strategy, including website maintenance, newsletter content and distribution, event coordination, and other outreach activities. The incumbent will work closely with the executive teams of SCA and CSCS to develop promotional content and to develop communication portfolios to meet the needs of our dynamic research network.

Close date: 5 Sep 2017

Position Description and Selection Criteria

0043864.pdf

For information to assist you with compiling short statements to answer the selection criteria, please go to our website.

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Sperm from stem cells could help some types of male infertility – BioNews

Tuesday, August 22nd, 2017

Cells from genetically infertile male mice have been turned into sperm, and used to produce healthy pups.

Researchers hope the technique could one day help men with certain causes of infertility. Experts hailed the work as 'very encouraging' and 'fascinating science', while noting that the technique is experimental only, and raises ethical and legal considerations should it be developed for humans.

'Our approach allowed us to create offspring from sterile XXY and XYY mice,' says first author Dr Takayuki Hirota at the Francis Crick Institute in London. 'It would be interesting to see whether the same approach could one day be used as a fertility treatment for men with three sex chromosomes.'

Having an extra sex chromosome three instead of two can cause infertility in mice and men. In humans, about onein 500 men may have either an extra X chromosome (Klinefelter's syndrome) or an extra Y chromosome (Double Y) in their genomes.

British and Japanese researchers aimed to removethe extra sex chromosome in infertile male mice with this problem. They took cells from the ears of the mice and cultured them in the lab to collect fibroblast (connective tissue) cells. They then coaxed the fibroblast cells into iPS (induced pluripotent stem) cells in the process some of the cells lost their extra sex chromosome.

Using specific chemical signals, the researchers could guide these stem cells into becoming the cells which can develop into sperm. When these were transplanted into the testes of live mice, they matured into sperm, which were used in assisted reproduction to give healthy pups.

Others agree the study offers potential. 'Although a mouse study, this research is exciting, since it raises the future possibility that sperm without the extra X chromosome could be made,' saidDr Channa Jayasena, a reproductive endocrinologist at Imperial College London. 'This could offer potential hope for affected couples.'

Indeed, a preliminary experiment by the researchers turning fibroblast cells from men with Klinefelter's syndrome into stem cells in vitro managed to lose the extra X chromosome.

But, Dr Jayasena notes the new study 'raises important ethical issues'.

Professor Allan Pacey at the University of Sheffield, UK, said: 'This is very encouraging. The only fly in the ointment is that currently the use of such sperm in the UK is not lawful and it would take a change of primary legislation to allow us to use such sperm in infertility treatment.'

While praising the study, Professor Adam Balen, chair of the British Fertility Society, said its application in improving fertility in men with Klinefelters syndrome 'is a long way off clinical practice'.

He also noted: 'Furthermore there are possible significant risks outlined in the paper which mean that any therapeutic application is far from certain.'

The study, published in Science, found that when the cells were transplanted into the testes of mice, some of the animals developed teratomas.

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Will CRISPR fears fade with familiarity? – Albany Times Union

Tuesday, August 22nd, 2017

(The Conversation is an independent and nonprofit source of news, analysis and commentary from academic experts.)

Patricia Stapleton, Worcester Polytechnic Institute

(THE CONVERSATION) The first test-tube baby made headlines around the world in 1978, setting off intense debate on the ethics of researching human embryos and reproductive technologies. Every breakthrough since then has raised the same questions about designer babies and playing God but public response has grown more subdued rather than more engaged as assisted reproductive technologies have become increasingly sophisticated and powerful.

As the science has advanced, doctors are able to perform more complex procedures with better-than-ever success rates. This progress has made in vitro fertilization and associated assisted reproductive technologies relatively commonplace. Over one million babies have been born in the U.S. using IVF since 1985.

And Americans acceptance of these technologies has evolved alongside their increased usage, as weve gotten used to the idea of physicians manipulating embryos.

But the ethical challenges posed by these procedures remain and in fact are increasing along with our capabilities. While still a long way from clinical use, the recent news that scientists in Oregon had successfully edited genes in a human embryo brings us one step closer to changing the DNA that we pass along to our descendants. As the state of the science continues to advance, ethical issues need to be addressed before the next big breakthrough.

Louise Brown was born in the U.K. on July 25, 1978. Known as the first test-tube baby, she was a product of IVF, a process where an egg is fertilized by sperm outside of the body before being implanted into the womb. IVF opened up the possibility for infertile parents to have their own biologically related children. But Browns family was also subjected to vicious hate mail, and groups opposed to IVF warned it would be used for eugenic experiments leading to a dystopian future where all babies would be genetically engineered.

The reaction in the U.S. had another layer to it when compared to other developed countries. Here, research on embryos has historically been linked to the debate on abortion. The 1973 Supreme Court decision to make abortion legal in Roe v. Wade fueled anti-abortion groups, who also oppose research on human embryos.

Embryonic research and procedures offer the hope of eliminating devastating diseases, but scientists also destroy embryos in the process. Under pressure from these groups over the ethical implications of embryo creation and destruction, Congress issued a moratorium in 1974 on federally funded clinical research on embryos and embryonic tissue, including on IVF, infertility and prenatal diagnosis. To this day, federal funds are still not available for this type of work.

In hindsight, the sharp media attention and negative response from anti-abortion groups to IVF didnt accurately represent overall public opinion. The majority of Americans (60 percent) were in favor of IVF when polled in August 1978, and 53 percent of those polled said they would be willing to try IVF if they were unable to have a child.

So while the intense media coverage at the time helped inform the public of this new development, the insensitive labeling of Louise Brown as a test-tube baby and warnings about dystopian results didnt stop Americans from forming positive opinions of IVF.

In the nearly 40 years since IVF was introduced for use in humans, scientists have developed several new technologies from freezing eggs to genetically testing embryos before implantation that have improved patient experience as well as the chances that IVF will result in the birth of a baby. The announcement of each of these breakthroughs has resulted in flurries of media attention to the ethical challenges raised by this type of research, but there has been no consensus social, political or scientific on how to proceed.

Americans general opinion of assisted reproductive technologies has remained positive. Despite opposition groups efforts, surveys show that Americans have separated out the issue of abortion from embryonic research. A Pew Research Center poll from 2013 revealed that only 12 percent of Americans say they personally consider using IVF to be morally wrong. Thats a significant decrease from the 28 percent of respondents in 1978 who replied that they opposed the procedure for being not natural. In addition, the 2013 poll showed that twice as many Americans (46 percent) said they do not personally consider using IVF to be a moral issue compared to the number of Americans (23 percent) who said they personally do not consider having an abortion to be a moral issue.

Although most Americans dont think of embryonic research and procedures like IVF as a moral issue or morally wrong, the introduction of new technologies is outpacing Americans understanding of what they actually do.

Polls from 2007-2008 showed that only 17 percent of respondents reported that they were very familiar with stem cell research, and that there was a relative absence of knowledge about even the most prominent of the embryo-research issues. When Americans are asked more specific questions that explain IVF, they show less support for certain procedures, like freezing and storing eggs or using embryos for scientific research.

In light of recent developments, surveys show that nearly 69 percent of Americans have not heard or read much or know nothing at all about gene editing. Additionally, support for gene editing depends on how the technology will be used. A majority of Americans generally accept gene editing if the purpose is to improve the health of a person, or if it will prevent a child from inheriting certain diseases. The scientists in Oregon used a gene-editing technique that allowed them to correct a genetic defect in human embryos that causes heart disease. This type of progress falls into the category that most Americans would support.

But the technique thats used to make this correction, known as CRISPR-Cas9, can potentially be used for editing genes in other ways, not just to eliminate diseases. The success of the Oregon team opens the door to many possibilities in gene editing, including ones unrelated to health, such as changes to appearance or other physical characteristics.

Advancements in assisted reproductive technologies have happened rapidly over the last few decades, leading to over five million births worldwide. But as common as these procedures have become, scientists are not yet in agreement over how to integrate CRISPR and gene editing to the IVF toolkit. There are concerns about changing the genomes of human embryos destined to be babies, particularly since any modifications would be passed on to future generations. Scientific committees have noted that decisions on whether and how to use gene editing should be revisited on a regular basis. The newest breakthrough with CRISPR is providing us with one of those opportunities.

We should focus our attention on answering the ethical questions that have long gone unanswered: What are the boundaries to this type of research? Who decides what is an ethical use of CRISPR? What responsibility do we have to people affected by genetic conditions? Who pays for these medical procedures? How will this research and potential clinical use be regulated?

The successful use of assisted reproductive technologies has skyrocketed in the last decade, making Americans complacent about some of the ethical concerns that these procedures raise. Its important that we engage with these issues now, before gene editing becomes as familiar to us as IVF.

This article was originally published on The Conversation. Read the original article here: http://theconversation.com/will-crispr-fears-fade-with-familiarity-82419.

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Will CRISPR fears fade with familiarity? - Albany Times Union

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Dolphins QB Ryan Tannehill will reportedly have surgery, miss entire season – FOXSports.com

Saturday, August 12th, 2017

MIAMI (AP) Ryan Tannehill has decided surgery can no longer be avoided.

The Miami Dolphins quarterback will undergo an operation to repair the torn ACL in his left knee and will miss the entire season, a person familiar with the decision said Friday.

The person confirmed the decision to The Associated Press on condition of anonymity because the Dolphins hadnt disclosed it publicly. Tannehill will be placed on injured reserve, the person said.

Tannehill, who missed the final four games of last season with two sprained ligaments in his knee, reinjured it a week into training camp on Aug. 3. The Dolphins consulted with specialists before the team and Tannehill decided surgery was the best option.

Tannehill opted not to have surgery after last seasons injury, and instead rehabilitated the partially torn ligaments and underwent stem cell treatments.

Jay Cutler, who parted with the Chicago Bears after eight seasons, agreed to delay his fledgling network TV career and signed a $10 million, one-year contract Monday to replace Tannehill. Cutler, 34, might make his Dolphins debut in their second exhibition game next Thursday.

Tannehill won the No. 1 job for Miamis opener in his rookie season of 2012 and made 77 consecutive starts before his injury last season. Hes expected to be ready for the start of training camp next season.

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Stem cell research: the debate continues to rage – CosmicNovo.com (Science and Technology)

Saturday, August 12th, 2017

The list of medical or scientific endeavours mired in controversy is fairly short, but stem cell research and related therapy are some of the most contentious issues in modern science. Simply, stem cell therapy involves the use of stem cells to treat or prevent a disease or condition, a form of this type of treatment involves bone marrow transplant which is a relatively common operation. Whilst this may not strike you as something worthy of debate, it is because it is the further research in stem cell therapy that has become a battleground of ideology and discussion.

There is research and case studies showing that stem cell therapy involving cells from the umbilical cord blood of infants as well embryonic stem cells from human embryos. Although the former is fairly innocuous, is the latter, which requires a human embryo that has caused controversy, as to harvest them, you must destroy the embryo.

Understandably, there is a lot of opposition to the use of human embryonic stem cells in research, often times based on a range of philosophical, moral, or religious objections, with most protesters worried of cloning embryos just to harvest these cells. Theology, philosophy and morality aside, the medical possibilities of embryonic stem cells are almost limitless.

Doctors have explained that due to the nature of these cells, they are more flexible and can be put to a far greater range of uses than other more conventional stem cells. They pertain that these cells could help treat an incredibly high amount of diseases and illnesses including but not limited to neurodegenerative diseases and conditions such as diabetes and heart disease.

Of course, this only adds to the mounting debate surrounding the use of these cells, further driving questions from a moral and philosophical viewpoint as to whether or not it is ethical to be using embryonic stem cells, despite the purported benefits. Although research continues into the use of these specific cells, and governments grapple with potential legal and medical ramifications, it is important to realize that there are several other stem cell opportunities that do not require the same controversial source.

Although there has been blowback on other forms of research in the sector namely the use of umbilical blood the use of bone marrow transplants and other such alternative continue to save lives daily. However, until society catches up with science and medicine, there will be a continued debate as to the ethics and morality of this type of research, its applications, and what it could open the door for.

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Stem cell research: the debate continues to rage - CosmicNovo.com (Science and Technology)

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Congressional voting record may make or break Putnam’s run for governor – Miami Herald

Saturday, August 12th, 2017

Adam Putnam was the youngest member of Congress when he went to Capitol Hill in 2001 six months shy of his 26th birthday.

Success came quickly to the newcomer from Bartow, whose grasp of policy and skill at messaging made him a protg of House Speaker Dennis Hastert and No. 3 in the House Republican hierarchy.

Along the way, Putnam racked up a record of votes, some of which haunt him as he seeks the Republican nomination for governor next year in a field that is yet to take shape.

Putnam voted for a new Medicare prescription drug benefit; $700 billion for the so-called Wall Street bailout; $187 billion to rescue mortgage lenders Freddie Mac and Fannie Mae; and $2 billion for a Cash for Clunkers car trade-in program.

Lets go back and look at what the world was like, Putnam said in a Herald/Times interview at a Masonic lodge in rural Wausau, recalling the Great Recessions misery in 2008 and 2009 with its double-digit unemployment. Every decision I made then was hard but had working men and women and families in mind.

But for Putnam, who has long dreamed of life in the Governors Mansion, one issue in Congress still stalks him like no other.

On immigration, many conservatives see any attempt to chart a pathway to citizenship for undocumented immigrants as amnesty, a vague but toxic term in a race for governor in which Putnam is sure to face serious challenges from the right.

Amnesty is an elastic word. The dictionary says its the act of an authority [such as a government] by which pardon is granted to a large group of individuals. Sen. Jeff Flake, R-Ariz., has called it an unconditional pardon.

Putnam, whose familys citrus and cattle business employs immigrants who are legally eligible to work in Florida, twice pushed for legislation in Congress that would have helped undocumented workers. Both proposals had conditions that had to be met, such as specific work hours and a clean criminal record.

Agriculture Commissioner Adam Putnam speaks with Bob Swindell, with the Greater Fort Lauderdale Alliance and Jose Basulto, with Memorial Hospital System, at the Greater Fort Lauderdale Alliance Luncheon on May 15, 2017.

Emily Michot emichot@miamiherald.com

Eight years ago, he was a co-sponsor of H.R. 2414, a bill known as the Agricultural Jobs, Opportunity, Benefits and Security Act, or the Ag Jobs Act of 2009.

A bipartisan effort in President Barack Obamas first term to repair the nations broken immigration system, it had a guest worker program and was supported by some of the most liberal members of Congress such as Democratic Sen. Dianne Feinstein of California.

That state, like Florida, has an agricultural economy that needs immigrant labor, both legal and illegal.

The bill had a pilot program of earned status for immigrants, who after working a specific number of hours in the fields, would get work visas known as blue cards. Then, after three years of lawful labor, they could apply for citizenship an idea labeled amnesty by a prominent conservative group

This would provide amnesty and a direct path to citizenship, the Heritage Foundation said at the time. Reject amnesty.

It died without a vote. Then as now, Putnam rejects the notion that he favors amnesty for immigrants.

Ive never supported amnesty, he said. I worked to find a way to fix a broken immigration system.

After a White House meeting on immigration with President Obama and congressional leaders in 2009, Putnam said: Immigration is a complex issue, so there are any number of reforms possible. But granting amnesty to people who are here illegally must not be one of them.

Six years earlier, in 2003, Putnam was one of a dozen House Republicans who co-sponsored a bill, H.R. 2899, with a guest worker program for undocumented immigrants in all job sectors, patterned after a proposal by Arizona Sen. John McCain. It failed to pass.

Former U.S. Rep. Robert Wexler, D-Boca Raton, who served in Congress from 1996 to 2010, praised Putnams approach to immigration.

He often was about solving problems, Wexler said. He was part of the responsible wing of the Republican Party.

But asked if Putnam still supports those ideas, his campaign said it was unrealistic to take stands on bills that are dead.

Adam Putnam felt then and does now that our national immigration system is broken and Washington needs to fix it, spokeswoman Amanda Bevis said.

Jack Oliver of North Palm Beach, legislative director of an anti-immigration group, Floridians for Immigration Enforcement, said hes disillusioned with Putnams overall record on immigration, including his lack of support for a federal law known as E-Verify to check the legal status of immigrant workers.

Oliver recalled that Putnam, in his first year on Floridas Cabinet in 2011, worked with then-Republican Sen. JD Alexander of Lake Wales to narrow the scope of an E-Verify bill (SB 2040) in the Florida Senate.

Adam Putnam campaigns at the 48th annual Possum Festival in Wausau, Fla., on Saturday, Aug. 5.

Paul Goulding Real Florida Media

Alexander noted that his family citrus businesses in Polk County employed immigrants, and the E-Verify proposal drew flak from contractors and the Florida Chamber of Commerce, which questioned its reliability and accuracy.

The amended bill limited E-Verify to one-stop career centers and state agencies and exempted private employers.

Its the same old thing, Oliver said of Putnam. When they run, they say theyre for something. Then when push comes to shove, they dont follow through. Were just kind of leery. Hes been a disappointment in the past.

Putnams campaign said that he opposes a patchwork of state laws and that immigration is a federal responsibility.

Throughout Putnams decade on Capitol Hill, he compiled a voting record that The Almanac of American Politics called reliably conservative.

Putnam consistently got A-plus grades from the NRA, and his ratings from the American Conservative Union ranged between 92 and 100. Congressional Quarterly said Putnam voted with President George W. Bush about 98 percent of the time.

Numbers USA, an advocacy group that supports lower immigration levels, was not so generous. Putnams record with the group was a 65 a C.

That reflected both his support for guest worker bills and his opposition to other proposals, such as giving legal status to Dreamers, children who came to the U.S. illegally, and a requirement that federal contractors use E-Verify.

On other key issues, Putnam voted for Bushs tax cuts, oil drilling in the Arctic National Wildlife Refuge and allowing the parents of Terri Schiavo to intervene in the Pinellas County womans right-to-die case.

He opposed stem cell research, raising the minimum wage and ending a ban on same sex marriages.

Putnam, 43, is a rarity: a candidate for Florida governor with a long voting record in Congress. Democrat Lawton Chiles, also a Polk County native, walked away from a safe U.S. Senate seat and ran for governor in 1990. Jim Davis had served as a Democratic Tampa U.S. representative for 10 years when he ran for governor in 2006. His opponent, Charlie Crist, ran a series of TV ads that lampooned his tenure in Congress.

Putnams track record on Capitol Hill has not yet emerged as an issue because he didnt have announced opponents until Friday.

Sen. Jack Latvala, R-Clearwater, joined the race Friday, filing papers to make his campaign official. He could seek a moderate path to the Republican nomination in a four- or five-person race.

Adam Putnam campaigns at the 48th annual Possum Festival in Wausau, Fla., on Saturday, Aug. 5.

Steve Bousquet Tampa Bay Times

U.S. Rep. Ron DeSantis, R-Ponte Vedra Beach, and House Speaker Richard Corcoran, R-Land OLakes, are both poised to run as conservatives, with Corcoran hiring a pollster and political advisers who shaped President Donald J. Trumps message and TV ads in 2016.

Corcoran pollster Tony Fabrizio was among the first to directly attack Putnam over immigration.

Fabrizio posted a tweet July 7 on Putnams lengthy pro-illegal immigration record. On Aug. 1, Fabrizio again tweeted: Adam Putnam is for amnesty for illegals.

PolitiFact rated Fabrizios claims half-true because of Putnams frequent votes to stop illegal immigration, such as a 2010 vote to oppose amnesty for so-called Dreamers.

Putnam won two statewide elections, but they were for the most obscure Cabinet post.

In whats sure to be a brutal primary, Putnams rivals will try to define him before he can do it himself, using those votes in Congress.

His opponents are thinking, We will define who Adam used to be before he has the opportunity to, said a veteran Florida political strategist, J.M. (Mac) Stipanovich, a harsh critic of Trump who says Putnam is pandering to supporters of the president.

Every election cycle is different, but they are clearly fighting the last war 2016. Its dispiriting, Stipanovich said.

Putnam has led a charmed life in Florida politics.

His closest race was his first run for Congress, in 2000, when he got 57 percent of the vote. He has never been seriously tested in a Republican primary.

Anticipating the attacks, Putnam said: Im a consistent conservative. Im a long, strong conservative. Ive been attacked by the media from time to time for being too much of a conservative.

Tampa Bay Times researcher Caryn Baird contributed to this report.

As a member of Congress from 2001-10, Adam Putnam cast hundreds of votes and rose to No. 3 in the House GOP hierarchy, which required him to support his partys agenda. Some Putnam votes will be controversial with Republican primary voters if, as expected, he is challenged from the right.

Year

Issue

Position

2003

Create new visa program for undocumented immigrants

Yes*

2003

Add a new prescription drug benefit under Medicare

Yes

2005

Raise members of Congress salaries by $3,100, to $165,200 a year

Yes

2008

Increase the federal debt ceiling

Yes

2008

Override Pres. Bushs veto of farm programs, crop subsidies, food stamps

Yes

2008

Approve $700 billion Wall Street bailout for banks to buy distressed homes

Yes

2009

Grant U.S. citizenship to farm workers who work a certain number of years

Yes*

2009

Approve $187 billion bailout for mortgage lenders Fannie Mae, Freddie Mac

Yes

2009

Spend $2 billion for Cash for Clunkers vehicle trade-in program

Yes

* Neither bill passed, but Putnam was a co-sponsor of both.

Sources: Almanac of American Politics; CQs Politics in America; Congressional Record; votesmart.org; Congress.gov; legistorm.com

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Britain can lead the world in gene editing – The Times

Saturday, August 12th, 2017

August 7 2017, 12:01am,The Times

Matt Ridley

We can uphold our bold but sensitive approach to regulation while seizing opportunities in agriculture and medicine

Britain has an opportunity to seize on the latest breakthroughs in gene editing and pioneer new approaches in agriculture, research and medicine. We are well placed to be bold but responsible gene editors. Bolder than continental countries, looking over their shoulder to the disapproving Roman Catholic church; more responsible than China, where decisions on such matters are taken by officials with little consultation with the public; and without the culture battles over moral and legal issues that so often divide the United States on matters of biology.

This is partly a matter of good regulation. Britains pioneering debate in the 1980s on how to regulate embryo research, allowing such work up to 14 days, drew the sting from subsequent arguments about cloning, stem cells and

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Opinion: Human genome editingwe should all have a say – Phys.Org

Wednesday, August 2nd, 2017

Mitalipov's team is not the first to genetically modify human embryos. This was first accomplished in 2015 by a group of Chinese scientists led by Junjiu Huang. Mitalipov's team, however, may be the first to demonstrate basic safety and efficacy using the CRISPR technique.

This has serious implications for the ethics debate on human germline modification which involves inserting, deleting or replacing the DNA of human sperm, eggs or embryos to change the genes of future children.

Ethically controversial

Those who support human embryo research will argue that Mitalipov's research to alter human embryos is ethically acceptable because the embryos were not allowed to develop beyond 14 days (the widely accepted international limit on human embryo research) and because the modified embryos were not used to initiate a pregnancy. They will also point to the future potential benefit of correcting defective genes that cause inherited disease.

This research is ethically controversial, however, because it is a clear step on the path to making heritable modifications - genetic changes that can be passed down through subsequent generations.

Beyond safety and efficacy

Internationally, UNESCO has called for a ban on human germline gene editing. And the "Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine" the Oviedo Convention specifies that "an intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants."

In a move away from the positions taken by UNESCO and included in the Oviedo Convention, in 2015 the 12-person Organizing Committee of the first International Summit on Human Gene Editing (of which I was a member) issued a statement endorsing basic and preclinical gene editing research involving human embryos.

The statement further stipulated, however, that: "It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application."

Mitalipov's research aims to address the first condition about safety and efficacy. But what of the second condition which effectively recognizes that the human genome belongs to all of us and that it is not for scientists or other elites to decree what should or should not happen to it?

Modification endorsed

Since the 2015 statement was issued, many individuals and groups have tried to set aside the recommendation calling for a broad societal consensus.

For example, in February 2017, the U.S. National Academy of Sciences and National Academy of Medicine published a report endorsing germline modification. It states unequivocally that "clinical trials using heritable germline genome editing should be permitted" provided the research is only for compelling reasons and under strict oversight limiting uses of the technology to specified criteria.

Seeds of change in Canada

In Canada, it is illegal to modify human germ cells. Altering "the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants" is among the activities prohibited in the 2004 Assisted Human Reproduction Act.

Worried that "Canadian researchers may fall behind on the international scene" and that "restrictive research policies may lead to medical tourism," the Canadian Institutes for Health Research (with input from the Canadian Stem Cell Network) has begun to plant the seeds of change.

In its Human Germline Gene Editing report, CIHR hints at the benefits of changing the legislation. It also suggests professional self-regulation and research funding guidelines could replace the current federal statutory prohibition.

Future of the species

With the recent announcement of Mitalipov's technological advances and increasing suggestions from researchers that heritable modifications to human embryos be permitted, it is essential that citizens be given opportunities to think through the ethical issues and to work towards broad societal consensus.

We are talking about nothing less than the future of the human species. No decisions about the modification of the germline should be made without broad societal consultation.

Nothing about us without us!

Explore further: Genome editing in human cells

This article was originally published on The Conversation. Read the original article.

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Patents in Brazil – Lexology (registration)

Wednesday, August 2nd, 2017

What are the criteria for patentability in your jurisdiction?

A creation must first be considered an invention or utility model. There is no statutory definition of invention, although the Brazilian Patent Statute does provide a list of what is not an invention. A utility model, on the other hand, is defined as an object of practical use or a part thereof.

To be patentable, an invention must meet the requirements of novelty, inventiveness and industrial applicability. Utility models share the same requirements of novelty and industrial applicability, but the level of inventiveness required for utility models is lower than that required for inventions.

What are the limits on patentability?

The Patent Statute stipulates that the following are not considered to be inventions or utility models and are therefore unpatentable:

To what extent can inventions covering software be patented?

Only the softwareper se that is, the source code is excluded from patentability. Any technical result obtained from a given software can be patented (eg, a method carried out by software instructions and systems or devices affected by software instructions). The Brazilian Patent and Trademark Office (BPTO) Examination Guidelines state:

An industrial creation process or product associated with the process implemented by a computer program, which solves a problem found in the technique not solely concerning the way in which this computer program is written, can be considered an invention.

To what extent can inventions covering business methods be patented?

Business methodsper seare not patentable. However, the simple fact that a method has a commercial nature does not necessarily render it ineligible for patent protection. The claimed matter must be analysed as a whole, particularly if it solves a technical problem. For example, a method for authenticating a user for a financial transaction and a method for increasing the security of bank accounts both constitute patentable subject matter.

To what extent can inventions relating to stem cells be patented?

Stem cells are not eligible for patent protection a claim directed to a stem cell in its preamble will be rejected. Natural living beings (eg, animals), in whole or in part (eg, cells), are excluded from patentability even if they are in modified or recombinant form. Therefore, cells derived from animals are not considered to be inventions in Brazil.

However, compositions containing stem cells, the processes of obtaining stem cells and applications (ie, uses) thereof may be patentable if they do not imply or include a therapeutic or surgical method.

Are there restrictions on any other kinds of invention?

Yes, the Patent Statue sets out additional limitations on patentable subject matter. The following are not patentable:

Grace period

Does your jurisdiction have a grace period? If so, how does it work?

Yes. Any disclosure of the invention or the utility model made within one year before filing the application in Brazil or the priority date claimed will not be considered as a prior art reference, provided that such disclosure is made by:

Oppositions

What types of patent opposition procedure are available in your jurisdiction?

Pre-grant and post-grant oppositions are available. Pre-grant oppositions essentially entail submitting observations up to the end of the patent application examination period. It is not a formal opposition procedure, inasmuch as the applicant is not obliged to submit a response. The BPTO examiner will take into account any submitted observations during the substantive examination phase. Post-grant oppositions, on the other hand, must be formally commenced by a party with a legitimate interest within six months from grant. The patentee will be notified to respond within 60 days, after which a first opinion from the BPTO concerning the nullity request will be issued. Both parties will then have 60 days to submit their final considerations.

Apart from oppositions, are there any other ways to challenge a patent outside the courts?

Yes. If a patent application is rejected after substantive examination and the applicant decides to appeal, it is possible for a third party to submit counterarguments to the appeal within 60 days of its publication.

How can patent office decisions be appealed in your jurisdiction?

Before the BPTO or the courts.

Timescale and costs

How long should an applicant expect to wait before being granted a patent and what level of cost should it budget for?

The average backlog at the BPTO is around 11 years. This timeframe may increase, depending on the technical nature of the application (eg, backlogs for telecoms and pharmaceutical applications can extend up to 15 years). In view of this, applicants should consider using some of the fast-track options available. Costs will depend on the complexity of each matter, but applicants should budget $10,000 on average.

Enforcement through the courts

Strategy

What are the most effective ways for a patent owner to enforce its rights in your jurisdiction?

Filing an infringement suit before a state trial court is the best way to enforce patent rights in Brazil. The patent owner can request the court to grant preliminary injunctive relief against the infringer. In practice, the legal standards for obtaining injunctions are relatively low when compared to other jurisdictions, since there is no need to give notice to the defendant or to post a bond or give security, and typically there are no discussions regarding the balance of hardships or public interest. This makes Brazil an attractive jurisdiction for patent owners seeking to enforce their rights.

What scope is there for forum selection?

As a general rule, the plaintiff must file the suit before the state trial court of the venue where the infringer is headquartered. Nevertheless, patent infringement suits in which damages are claimed alongside restraining orders may be filed wherever the infringement is taking place or even where the plaintiff resides.

Pre-trial

What are the stages in the litigation process leading up to a full trial?

First, there is a mandatory conciliation hearing as an attempt at alternative dispute resolution, unless both parties indicate that they have no interest in doing so. Thereafter, if no agreement is reached, the parties are entitled to file briefs with their arguments and to present documents in support of their case. At this stage, it is common to file technical and legal opinions prepared by renowned scholars or experts in their respective fields. Next, the judge decides on the controversies that need to be resolved and an unbiased court-appointed expert prepares a technical report regarding the case. Courts typically rely on the technical report prepared by the court-appointed expert. After this, the parties can file briefs in response to the technical report prepared by the court-appointed expert and can present final arguments. Finally, the judge in charge of the case issues a decision on the merits (bench trial).

How easy is it for defendants to delay proceedings and how can plaintiffs prevent them from doing so?

Most of the delay depends on the judges schedule and willingness to rule on the case. Another factor is the time that it takes the court-appointed expert to deliver the technical report. Defendants often try to delay the proceedings by filing pointless motions, unnecessary questions for the courts expert or unnecessary interlocutory appeals. However, the new Federal Rules of Civil Procedure (adopted in 2015) provide parties fewer appeal opportunities, which makes delaying attempts less effective. Also, it is now harder to delay the proceedings because such attempts may be punished by a court-issued fine. Nevertheless, if the plaintiff can obtain preliminary injunctive relief, the defendant will have no interest in delaying the procedure.

How might a party challenge the validity of a patent through the courts in anticipation of a potential suit for infringement being issued against it?

Brazil has a bifurcated system (similar to the German and Japanese systems) whereby invalidity suits must be filed in separate court proceedings before federal district courts (while infringement actions are filed before state trial courts).

At trial

What level of expertise can a patent owner expect from the courts?

Most patent-related cases are filed before the courts sitting in Rio de Janeiro, Sao Paulo and Brasilia. Except for certain judges in these jurisdictions, most Brazilian courts have no expertise in patent law.

Are cases decided by one judge, a panel of judges or a jury?

Cases are decided by a single judge at the first-instance trial level and by a panel of appellate court judges at the appellate level. Juries do not decide IP-related disputes in Brazil.

If jury trials do exist, what is the process for deciding whether a case should be put to a jury?

Not applicable.

What role can and do expert witnesses play in proceedings?

Expert witnesses play a key role in convincing the judge to grant or reject a request for preliminary injunctive relief. Moreover, they work with the unbiased court-appointed expert during the expert examination, addressing questions to him or her and delivering opinions on his or her technical report.

Does your jurisdiction apply a doctrine of equivalents and, if so, how?

Yes, the Patent Statute provides for patent infringement on an equivalence of means basis. However, it does not set out the criteria for applying the doctrine of equivalents and there is no binding precedent establishing a test or standard for applying the doctrine.

Is it possible to obtain preliminary injunctions? If so, under what circumstances?

Yes. The legal requirements for obtaining injunctions arefumus boni juris(ie, there is a likelihood of the complaint being decided in favour of the plaintiff) andpericuluminmora(ie, immediate measures are needed to cease the infringement and thus prevent the plaintiff from bearing further damages).

How are issues around infringement and validity treated in your jurisdiction?

Infringement suits must be brought before state courts, while invalidity suits must be brought before federal courts against both the patent owner and the Brazilian Patent and Trademark Office.

Will courts consider decisions in cases involving similar issues from other jurisdictions?

Attorneys typically quote foreign precedents in support of their arguments, particularly when there is no Brazilian precedent or rule dealing with the issue. However, judges rarely cite foreign cases or rely on them to ground their own decisions.

Damages and remedies

Can the successful party obtain costs from the losing party?

The prevailing party may recover a small part of the attorneys fees, in addition to court costs and the fees charged by the court-appointed expert.

What are the typical remedies granted to a successful plaintiff?

A permanent injunction preventing the defendant from using the claimed technology and damages.

How are damages awards calculated? Are punitive damages available?

Damages are calculated based on:

The basis chosen for damages calculation depends on what works best for the plaintiff. There are no statutory punitive damages and such requests are usually rejected pursuant to case law.

How common is it for courts to grant permanent injunctions to successful plaintiffs and under what circumstances will they do this?

Courts often grant permanent injunctions whenever the final ruling favours the rights holder.

Timescale and costs

How long does it take to obtain a decision at first instance and is it possible to expedite this process?

Most courts take approximately three years to issue a first-instance decision on the merits. The timescale depends on the judges schedule and willingness to rule on the case, as well as on how long the court-appointed expert takes to prepare and present his or her technical report.

How much should a litigant plan to pay to take a case through to a first-instance decision?

Costs vary significantly according to the case, but a litigant should expect to spend at least $200,000 from the beginning of the case until a first-instance decision on the merits, including legal fees, court costs and fees charged by the court-appointed expert.

Appeal

Under what circumstances will the losing party in a first-instance case be granted the right to appeal? How long does an appeal typically take?

The defeated party is always entitled to appeal the decision. A ruling by the court of appeals usually takes up to three years.

Options away from court

Are there other dispute resolution options open to parties that believe their patents to be infringed outside the courts?

Alternative dispute resolution methods are available, but they are not relevant to most patent infringement cases.

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More Americans Than Ever Say Polygamy Is Morally Acceptable – HuffPost

Tuesday, August 1st, 2017

The practice of polygamy, or having more than one spouse at the same time, is illegal in all 50 states. But the percentage of Americans who say the practice is morally acceptable reached an all-time high this year, according to a recent Gallup poll.

Gallup has measured American attitudes toward a number of social issues and behaviors, such as divorce, same-sex relations, and stem cell research, since 2001. In that time, the percentage of Americans who find polygamy to be morally acceptable has risen from seven to 17 percent.

Of all the issues and behaviors Gallup asked about, polygamy is among those to gain the most ground on moral acceptance since 2001, after same-sex relations, having a baby out of wedlock, sex between an unmarried man and woman and divorce.

Gallup initially attributed a 2011 bump in Americans acceptance of polygamy to a change in the wording of the question.Before 2011, Gallup defined polygamy as being when a husband has more than one wife at the same time.

But polygamy is actually a gender-neutral term that refers to the practice of having more than one spouse at a time. The majority of polygamous societies around the globe practice polygyny, when a man marries more than one woman. Another form of polygamy, called polyandry, refers to when a woman has more than one husband.

In 2011, Gallup changed its definition to reflect the terms gender-neutrality, identifying polygamy as when a married person has more than one spouse at the same time.

The change in wording coincided with a bump in the percentage of Americans who found polygamy morally acceptable but the continued rise likely has little to do with semantics, Gallup analyst Andrew Dugan wrote in a recent article.

The growing moral acceptance of polygamy may be part of a broaderleftward shifton moral issues, Dugan wrote, as well as increased depictions of the marital practice in popular media.

In the wake of the Supreme Courts 2015 ruling legalizing same sex marriage in all 50 states, scholar and cultural commentator Fredrik deBoer argued in article on Politico that polygamy would be the next horizon of social liberalism.DeBoer seemed to echo in positive terms what many social conservatives ominously warned: that legal changes to so-called traditional marriage could lead to anything even group marriage.

Within the U.S., though, polygamy tends to be most common among highly religious groups, including conservative Muslim immigrants from parts of Africa and Asia and the insular, isolated Fundamentalist Church of Jesus Christ of Latter-Day Saints.

The latter, a religious sect that broke off from the Church of Jesus Christ of Latter-Day Saints or Mormon Church in the 1930s, has been associated with the sexual abuse of children. Its leader,Warren Jeffs, was sentenced to life in prison in 2011 for having sex with underage girls.

In addition to several high-profile cases of child abuse linked to polygamous groups, plural marriage has also been linked to genetic disorders, child development problems for the offspring of such unions, a number of social issues including rape and substance abuse in societies where theres a disproportionate number of unmarried men as a result of polygyny, and even an increased risk of heart disease for polygamous men.

Even with polygamys problems and traditionally religious associations, Gallup found that acceptance of the practice is highest among non-religious Americans. Thirty-two percent of Americans who arent affiliated with any religion or who arent religious at all said polygamy ismorally acceptable.

Americans who identify as Christian were more likely than the overall same average to find the practice to be morally intolerable, even given the Biblical precedent for polygamy.

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Charlie Gard Dies, Leaving a Legacy of Thorny Ethics Questions – New York Times

Tuesday, August 1st, 2017

Our final wish

They lost their fight. On Thursday, Ms. Yates, who works as a caregiver, said in statement that the hospital had denied us our final wish.

Most people wont ever have to go through what we have been through, she said. Weve had no control over our sons life and no control over our sons death.

But the doctors treating Charlie at Great Ormond Street Hospital in central London countered that the risk of an unplanned and chaotic end to Charlies life at home was unthinkable. For months, the hospital had argued that he had irreversible brain damage, that the life support should be removed and that he should be allowed the right to die with dignity.

We deeply regret that profound and heartfelt differences between Charlies doctors and his parents have played out in court over such a protracted period, the hospital said in a statement. We will never do anything that could cause our patients unnecessary and prolonged suffering.

The case laid bare several issues, among them: Should parents or doctors or the courts have the final say in irreconcilable disputes over the treatment of sick children? And at what point should the limits of medicine be recognized and the parents of an infant be compelled to let go?

Biomedical ethicists said the case offered a cautionary tale of how a legal battle, scrutiny by the global news media and intractable differences between parents and doctors can spiral out of control in the social media age. Both the hospital and the parents in the Gard case dug in, their arguments playing out on Facebook and Twitter and capturing the attention of world figures including President Trump and Pope Francis.

The pope posted a message on his personal Twitter account shortly after news broke of the infants death. I entrust little Charlie to the Father and pray for his parents and all those who loved him, the tweet said.

Dr. Robert D. Truog, a physician at the pediatric intensive-care unit at Boston Childrens Hospital and the director of the Center for Bioethics at Harvard Medical School, said that Charlies parents were like parents all over the world they were willing to do absolutely anything to save the life of their child.

He added: They were the victims, not the cause, of this tragic situation.

The parents raw emotions played out in the courtroom, where Ms. Yates broke down in tears of frustration, at one point shouting, What if it was your child? before fleeing the room. At another moment, Mr. Gard, a mailroom worker, cried out, Evil after a hospital lawyer spoke.

On several occasions, both parents stormed out of the courtroom. Some of the lawyers and journalists covering the case were reduced to tears.

The case went through several courts, including Britains Supreme Court and the European Court of Human Rights, which backed the hospitals views, in part because experts said Charlie could be suffering. His parents insisted he was not.

Some American conservatives seized on the case as a warning of the pitfalls of socialized medicine and the abrogation of parental rights, even as the High Court judge presiding over the case, Nicholas Francis, countered that to make a scapegoat out of Britains National Health Service was nonsensical.

In most cases, medical experts say, doctors decide when to remove life support from an incurably ill child, in consultation with parents, and these cases rarely wind up in court. But in Britain, the courts are the final arbiter when irreconcilable disputes arise.

Charlie also became a powerful symbol for anti-abortion groups the world over. Protesters picketed outside Great Ormond Street Hospital, and Judge Francis denounced death threats against hospital staff members.

The case also spurred questions about the wisdom of offering parents the hope of experimental treatment when faced with an incurable disease. That debate took center stage after Dr. Michio Hirano, a neurologist at Columbia University Medical Center in New York, offered Charlies parents a ray of hope that an experimental treatment known as nucleoside therapy could improve Charlies condition.

The treatment had been tested on mice and on 18 people with a mutation in a gene known as TK2. But it had never been tried on someone with Charlies particularly debilitating form of mitochondrial DNA depletion syndrome, which is caused by a different genetic mutation.

During an often-acrimonious and emotional High Court hearing this month, Charlies parents argued that he should be allowed to receive the experimental treatment. But lawyers for Great Ormond Street Hospital countered that Dr. Hirano had held out hope without even examining the child or reviewing his full medical charts.

(Dr. Hirano said in a statement he had been contacted by the parents and agreed to speak with Charlies doctors to determine whether the experimental therapy he was developing could help improve the childs condition).

When Dr. Hirano traveled to London this month to examine Charlie, about six months after he had first been invited, a series of scans showed that the boy had suffered muscular atrophy, that the damage was irreversible and that treatment would be futile.

Ms. Yates criticized the hospital, saying it had dragged its feet about the treatment until it was too late.

The hospital consistently stood by its contention that treatment would have been useless and that Charlie had irreversible brain damage.

If Charlie has had a relationship with the world around him since his best interests were determined, it has been one of suffering, it said in a statement.

Dominic Wilkinson, a neonatologist and professor of medical ethics at Oxford University, said the case offered a tragic lesson about the risks of doctors offering uncertain hope to desperate parents. At the same time, he said, the case underscored the importance of mediation during a dispute about treatment, noting that the communication breakdown in the Gard case had all the attributes of a messy divorce.

To let a child go is incredibly difficult, but it is also incredibly important, he said. It is heartbreaking, but we have to know when to say enough is enough.

Dr. Truog of Harvard Medical School said the parents legal battle had tapped into the health care debate in the United States, and was being seized upon by some to affirm a money-driven system in which patients who have the means can pursue experimental treatments, even if the chances of success are slim. But he said experimental treatments must be weighed against the benefits for society as a whole.

In the United States, no one can demand nonbeneficial treatments simply by claiming they are paying out of pocket, he wrote in a recent article on the Gard case in The Journal of the American Medical Association.

It would be extremely rare for a hospital in the United States to admit patients for the exclusive purpose of receiving homeopathic therapy or unproven stem cell infusions, he wrote, regardless of how much the patient paid.

The parents now face coming to terms with Charlies death. Addressing the court this past week, Ms. Yates acknowledged that this would not be easy.

We are struggling to find any comfort or peace with all this, she said. But one thing that does give us the slightest bit of comfort is that we truly believe that Charlie may have been too special for this cruel world.

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India needs biannual amendment to Stem Cell Rules, Section 8 of Rules controversial: Dr Totey – pharmabiz.com

Tuesday, August 1st, 2017

India needs stem cell guidelines which can be amended biannually, said Dr Satish Totey, founder, chairman & managing director, Aureostem Research Pvt Ltd.

There cannot be a permanent set of guidelines. Every year we should make new draft guideline and seek public opinion. This must be discontinued immediately since valuable time and money are invested in the same. Instead it should be amended biannually, Totey told Pharmabiz.

Although the recent guidelines are comprehensive and may ensure patients get reliable and safe stem cell products in India in near future, yet the controversial section of this is Section 8. The section defines level of stem cell manipulation as minimum and major which is absolutely unnecessary and gives clear escape route to push unapproved stem cell for therapy by the clinicians, he said.

Desperate patients do not understand this terminology and often misled by the clinicians. For instance adipose derived stromal vascular fraction (AD-SVF) or bone marrow derived mononuclear cells (BM-MNC) which is minimal manipulated cells are being extensively used by the clinicians and giving impression to the patients that it do not require any clinical trials.

Now several clinicians use minimal manipulated cells for transplanting in retinas or in the brain without knowing its safety and efficacy. Much of what is being injected through minimum manipulated cells are not even stem cells. Moreover, one that come from fat or bone marrow are not capable of living in the human body for more than a day. There are several reports that patients become blind after such transplants, explained Dr Totey.

Another aspect which was totally ignored in the guideline is stem cell devices. Several clinicians use stem cell devices routinely in India which has limited approval from US FDA even for specific clinical conditions in the US. Therefore, such devices cannot be used in India. But clinicians are seen to mislead patients and giving impression that they have US FDA approval for stem cell therapy. This is a most dangerous procedure where, clinician can treat any condition without even having clinical speciality. For example, cosmetologists are now treating neurological or cardiac conditions. One of the key issues are oversight. But in these cases it is not just about desperate patients losing money but the genuine and tangible harms being done in the absence of oversight, he said.

Real progress in stem cell research and the development of cellular pharmaceuticals is not going to result from clinics making dramatic marketing claims. True progress requires extensive basic and pre-clinical research. It should be backed by carefully designed and properly conducted randomized clinical trials to ensure high-quality safety and efficacy data is generated.

Conducting such research in an ethical, scientific, and legal manner is difficult, costly, time-consuming, but necessary. More than 300 stem cell clinics that are operating in India are making dramatic advertising claims about stem cell treatments, but in most cases they have no evidence to support their hard-sell marketing, said Dr Totey.

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Stem Cell Therapy: You can be sexually active again – Vanguard … – Vanguard

Sunday, July 9th, 2017

By David Ikudayisi

Stem Cell Therapy comes in different types. Embryonic Stem Cell Therapy involves the use of embryonic stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo at 4 days old to around 12 days old, leading to the destruction of the blastocyst which raises ethical and religious issues. Therefore, this type of Stem Cell Therapy is not the focus of this piece. The focus is Adult Stem Cells (ADSCs) and Induced Pluripotent Stem Cells (iPSCs). iPSCs are produced in the laboratories by reprogramming adult cells to express embryonic stem cells characteristics whereas ADSCs are cells obtained from an adult patient who will also be the recipient of the same stem cells.

In the United States, we must transplant the cells back to the same patient on the same day, while in some countries, the stem cells can be cultured to increase the quantity of stem cells before transplanting them back to the same patient who donated them.

Stem Cell Transplantation is a complex process that needs the care of experts in Regenerative Medicine, a new speciality of medicine . In order to ensure that science remains as the vehicle for hope and not harm, the controversies associated with the legal, social and legal issues of certain areas of stem cells research and stem cells potential clinical applications must be carefully examined. Advancing treatment and care for patients to save a life is and must be the ultimate goal.

Regenerative Medicine helps people to naturally regenerate and rejuvenate their bodies from the different conditions they may be suffering from without using chemicals or the orthodox medicine we are used to, but Adult Stem Cells Platelet Rich Plasma (PRP), that is, blood plasma that has been enriched with platelets, and contains growth factors which may elicit the gathering of stem cells around the damaged region stimulating cellular proliferation and tissue regeneration. PRP can be used to promote healing of injured tendons, ligaments, muscles, joints and can be applied to various musculoskeletal problems. The process allows your own (autologous) stem cells to be re-introduced into/around areas of damage or chronic disease. As mentioned earlier, the extraction and transplantation of the stem cells are done on the same day in the United States. Bone marrow transplant has been the most widely used Stem Cell Therapy till date, but Adult Adipose-Derived (fat) Stem Cell Therapy is fast gaining popularity as fat harvesting is less invasive than bone marrow harvesting. You get more stem cells from fat than bone marrow, and fat stem cells are not age-dependent. Adult Stem Cell Therapy may hold answers to many questions and problems that we doctors believed had no solutions, especially neurological disorders. The therapy, with or without PRP, revitalizes and regenerates the body organs and systems; it also reverses and repairs many pending subclinical medical problems before they become apparent, including the diseases that are age-related. Generally, Adult Stem Cell Therapy is safe as shown by many published research reports and clinical trials. However, this does not guarantee that adverse effects cant occur if the treatment is done by physicians that are not properly trained.

The therapy has helped a lot of people all over the world to regain their lives from debilitating ailments and Nigerians are not left behind. There are people in Nigeria that were either wheelchair bound and walking with occasional use of a cane before but now walking without one; diabetes patients are able to have restoration of vision in their eyes, and some feel and look younger. It has helped chronic kidney disease patients in Nigeria that are on hemodialysis to either reduce the frequency of hemodialysis per week or like a patient that was recommended to have kidney transplant a year ago but who is now off hemodialysis and off diabetic medications, and remains stable for the past months. Men with Erectile Dysfunction are now feeling like young men again. I cannot but mention that the type of treatment protocol and dosage of stem cells used also play a role in the efficacy of the treatment, and not everyone will respond in the same manner. Most of the patients, in studies, showed improvements after the first treatment, and the few that needed second treatment went on to see great results after more treatments were done; needless to say that they were elated with the results. The only group of patients that will always need more than a couple of transplantation sessions are patients with neurological disorders. Latest researches and evidence-based studies showed the number of treatment sessions needed to get significant clinical results can decrease by adding Exosomes to the treatment sessions.

In a recently publication in Germany, the new concept, developed around 2010 of how stem cells works, was reinforced where it stated that most of the effects of stem cells are through the Paracrine effects, delivered by the Exosomes. Exosomes are extracellular cell-derived vesicles that are present in almost all biological fluids. When secreted by stem cells, Exosomes are those tiny communication vesicles that interact with surrounding cells, thereby creating therapeutic activity. This is called the Paracrine effect. The Paracrine soluble factors (communication vesicles) have specialized functions and play a key role in intercellular signaling and in the following properties immune modulatory, neuroprotective, anti-inflammatory, neurotrophic, angiotrophic, anti-apoptotic and anti-oxidatory. Stem cells also secrete other important proteins and cytokines that have healing properties.

There are some diseases that conventional treatments have no cure for, but Adult Stem Cell Therapy can reverse the symptoms of those diseases, repair and regenerate the damaged tissues or organs affected. In some cases, it significantly slows down the progression of the disorder. For example, it can regenerate the bony joints in arthritis, repair and strengthen partial rotator cuff tears and avascular necrosis of the hip without surgery, revitalize the sexual organs in men and women, regenerate renal cells in kidney diseases, modulate immune system without use of medications that have very serious side effects in conditions like Rheumatoid Arthritis, Lupus, Scleroderma, Crohns disease, etc. Another advantage is its application in neurological disorders like ALS and spinal cord injury.

Adult Stem Cell Therapy can gradually lower diabetic medications dosage and eventually may get the patients off diabetic medications. This is evidenced by stem cells in a hyperglycemic medium differentiating into pancreatic cells; therefore leading to increased development of new blood vessels, secretion of various products of the immune system, and upregulation of pancreatic transcription factors and vascular growth factor. This aids the pancreas to regenerate and boost its ability to produce insulin. In stroke patients, stem cells activate cells around the suffering brain tissue to catalyze rapid healing and to improve brain function, thereby restoring motor function. Until recently, it was believed that damage to the brain tissue was permanent. This is being challenged by the evidences of re-growth of brain cells and improvements of neurological function documented with the use of Adult Stem Cells.

A procedure called P-Shot for Men uses the PRP Therapy to resolve challenges relating to Erectile Dysfunction by regenerating the damaged tissues. It gives treated men the possibility of saving their relationships by increasing stamina, enjoying bigger and harder genitals, and eventually increasing the length and girth. Orgasm-Shot for Women, the regenerative medicine procedure for womens sexual function, leads to increased ability to have orgasm, better arousal from clitoris stimulation, decreased pain during intercourse, tighter vaginal opening, increased sexual desire and natural lubrication, and increased arousal from G-spot stimulation. In addition, because of the O-Shot rejuvenation capabilities, there is help available for women suffering from urinary stress incontinence without the need for invasive surgery.

Since the stem cells used are autologous, there is no risk of rejection of the stem cell transplant. Nevertheless, as with any procedure, there is a risk of infection which can be very minimal or non-existent if done under the right conditions. Adult Stem Cells Transplantation can also be considered by people looking for alternative treatments especially in the areas of diabetes, hypertension, kidney disease, female and male sexual dysfunction, joint pain, neurological disorder and autoimmune disease. The cost of treatment varies, and it is not for everyone. However, you cant place a price tag on life just as the saying goes that health is wealth.

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Bedford inmate’s family criticizes jail staff – Altoona Mirror

Sunday, July 9th, 2017

When state police apprehended 49-year-old Jeffrey McCracken June 25 for a suicide attempt, authorities set a date for his court hearing about a week later: July 3.

Instead, McCrackens loved ones spent July 3 at his funeral.

McCracken hanged himself at the Bedford County Correctional Facility sometime in the night between June 26 and 27, barely 48 hours after the near-miss attempt that had sent him there.

He wasnt under observation, officials said, because a screening had not shown any evidence he had any serious psychological issues.

I dont know how, within less than 14 hours of somebody attempting suicide with a gun, that you determine they are not a threat to themselves, McCrackens fiancee, Keri Moore of Burnt Cabins, said. I believe they failed him. The procedures are wrong. He should have been in a psych ward or some kind of medical place where he could be watched. There should have been something to help him along the way.

Moore has been in contact with a lawyer and is considering her legal options, she said this week.

Bedford County jail Warden Troy Nelson said a standard psychological screening, carried out by contracted medical staff, revealed little to indicate McCracken was a threat to himself. If it had, Nelson said, jail staff would have kept him in isolation and checked him regularly.

My investigation into Mr. McCrackens untimely death revealed that all facility protocol was handled accordingly and was simply an unfortunate occurrence beyond the control of my staff, Nelson said Friday in an email.

The events that led to McCrackens death began in the predawn hours of June 25 in a rural home along Great Cove Road in Fulton County.

McCracken and Moore had argued the prior evening, state police wrote in an affidavit. Between midnight and 1 a.m., McCracken called Moore to the kitchen, where he was armed with a long gun a rifle according to Moore, a shotgun according to state police.

McCracken pointed the gun at his own head. Moore lunged toward him and grabbed the barrel; McCracken pulled the trigger and a shot blasted into the ceiling.

Moore and her sister tried to wrestle the gun away, police wrote, but McCracken kept it and fled outside. The sisters called the police, who staged a manhunt in the woods and fields around the house.

Ive never ever felt that my life was in danger. Maybe thats why I felt so comfortable going after his weapon, Moore said last week.

McCracken had shown signs of depression, she said. The outdoorsman who once loved long solo trips in the woods a member of a national cave-exploration group and the Potomac Appalachian Trail Club had confided in her that he now feared being alone.

He was kind of hippie-like, Moore said. He loved animals, plants. He was a very passive person. No type of aggression out of him.

Now he was hiding from armed police. Moore said troopers reached him by cellphone and asked him to reveal himself: Come out; we just want to get you help.

Hours later, after sunrise, troopers found McCracken inside the house, Moore said. He was charged with three crimes: discharging a firearm into an occupied building (a felony) and simple assault and recklessly endangering another person, both misdemeanors.

Fulton County doesnt have a full-size jail, and officials in neighboring Franklin County threatened this year to eject their 20 Fulton County inmates as overcrowding worsens there. Instead, McCracken was sent directly to the Bedford County jail.

At Bedford, McCracken underwent a face-to-face psychiatric discussion with a contracted medical professional, Nelson said. A 2014 state inspection confirmed all inmates receive an initial health risk assessment within 24 hours of booking.

When Mr. McCracken arrived at the facility an Intake Screening was conducted per policy, whereby no signs of anger, depression or other related emotional abnormalities appeared to exist, Nelson said in an email. This particular screening includes a number of questions relating specifically to the inmates psychological state.

Inmates found to have emotional or psychological problems are held in an isolation cell, watched by guards and personally checked every 15 to 30 minutes, Nelson said.

Instead, McCracken was sent to a gymnasium with an attached restroom an area used as overflow when other blocks are full or undergoing maintenance, Nelson said. He could get out if his loved ones could secure $125,000 bond, court documents show.

After his booking, McCracken spoke with Moore twice by phone. He only vaguely recalled the night of the suicide attempt, she said.

He paused for a little while and said, Im sorry,' Moore said. I dont know how to put it. He didnt sound like himself.

He asked Moore to visit him the next day. She said she would.

Moores understanding of the events that followed stem largely from police who visited her afterward. Multiple attempts by the Mirror to reach Bedford County Coroner Rusty Styer were unsuccessful.

Sometime in the night of June 26 or the morning of June 27, McCracken walked to the attached bathroom, closed the door and hanged himself with a bedsheet, Moore said. It is unclear precisely how long it took for staff to find him, but Moore claims it took an hour.

County 911 dispatchers later said Styer was called to the scene at 6:07 a.m.

Officials then called Moores sister and told her police were on the way to explain what happened. Moore said she demanded answers: How could they have determined he wasnt a threat to himself? Why didnt he get treatment before he was sent to jail?

Since that day amid funeral planning and legal responsibilities Moore and others have sought legal help as they investigate what happened. Nick Hoffman, a Moore family friend with experience in law enforcement, said he has looked at case law on similar situations.

I think, if the guy would have got some proper treatment, he still wouldve been here today, Hoffman said.

Suicide is the leading cause of death in local and county jails, accounting for 35 percent of all deaths in 2014, according to the U.S. Department of Justice. Rates keep rising, with suicides jumping 13 percent from 2013-14, the latest year for which the department has released data.

Some jail deaths are unavoidable, and others have spurred policy changes. In 2014, after a Bedford County jail inmate died of a health condition, the county commissioners voted to pay for an additional medical shift, although they did not explicitly attribute the change to the death.

Hoffman remains confident, however, that McCrackens suicide could have been prevented.

They should have known better, Hoffman said. The main thing here is to set an example. You dont do this stuff.

Mirror Staff Writer Ryan Brown is at 946-7457.

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Stem cell agency faces leadership challenge – Capitol Weekly

Monday, July 3rd, 2017

News

by DAVID JENSEN posted 06.27.2017

Californias 12-year-old stem cell research effort is expected to give away tens of millions of dollars in public this week, but its most important matters issues that deal with its survival and future likely will be discussed behind closed doors at a meeting Thursday of its governing board.

On the table is the leadership of the $3 billion organization, which is scheduled to run out of cash in just three years, which amounts to a mere tick of the clock in the world of biomedical research. Beginning next week the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, will be minus its chief executive officer and its longtime counselor, who even predates the organizations actual creation in 2004.

CIRM has a checkered record in recruiting new presidents for a variety of reasons (seehere,hereandhere).

CIRM directors are scheduled to meet Thursday at the San Francisco Marriott hotel in Burlingame, Ca., to confirm the appointment of Maria Millan, CIRMs vice president of therapeutics, as interim president of the agency. She will assume the duties of Randy Mills, who is leaving CIRM next week to head the National Marrow Donor Progam.

Mills, who was paid $573,00 last year, also made it clear to the California Stem Cell Report in May that Millan is the appropriate person to take over the agency on a permanent basis after he leaves.

However, the decision is up to the 29-member board, which has scheduled an executive session Thursday to discuss the interim replacement for Mills. Hejoined the agency only three years ago but has left an impressive mark.

CIRM directors have also scheduled a July 17 meeting of their presidential search subcommittee to deal with the agencys leadership during what could be the last years of its life.

CIRM has a checkered record in recruiting new presidents for a variety of reasons (seehere,hereandhere). Some candidates have rejected offers. Other search efforts have been excessively prolonged.

The agency hopes to add 38 more trials over the next three years. But there are no guarantees that any will be successful.

Finding a new president from outside CIRM poses difficulties that would not have been in place, for example, five years ago. They include the tenuous future of CIRM along with the time needed for a normal executive search, plus the learning curve for a new CEO.

While CIRM is a small enterprise in some ways (less than 50 employees), it is an unusual mix of government, biotech business and academia, unlike any other state agency. The combination has raised hurdles in the past.

The clock is running out fast at the agency. Any alterations in the plan put in place by Mills, Millan and company could slow its efforts to fulfill voter expectations that the agency would actually generate a widely available therapy. CIRM is helping to finance 27 current clinical trials, which are the last stages in research prior to a product reaching the market. The agency hopes to add 38 more trials over the next three years. But there are no guarantees that any will be successful.

Millan can step in and pick up the job relatively seamlessly. Bringing in a CEO from outside could well take six months or more, including relocation. But serving as the head of an organization that could be out of business in three years may not be appealing to many and could prolong recruitment.

Looming in the background is a gossamer plan for another ballot initiative to fund CIRM beyond 2020.

If Millan is bypassed by the board, she may well leave the agency, triggering a cascade of departures as other CIRM employees also look to their own professional futures. An employee drain would hamper the agencys drive to come up with a commercial therapy.

James Harrison, the longtime counsel to the agency, is also leaving at the end of this week, returning to other pursuits at his private practice. Harrison has been a cornerstone of CIRM and has influence well beyond the not-so-simple legal matters involving the agency. He was also one of the authors of the 10,000-word ballot initiative that created the agency in 2004.

Scott Tocher, a longtime veteran of the agency, will replace Harrison. An announcement of the appointment is expected at the Thursday meeting.

Looming in the background is a gossamer plan for another ballot initiative to fund CIRM beyond 2020. Bob Klein, a Palo Alto real estate investment banker who led the campaign that created CIRM, is talking about a $5 billion bond measure on the ballot as early as November of next year. Some political observers have predicted a less-than-warm-reception for such a proposal, given that the agency has yet to measure up to its 2004 campaign promises.

Another, rival proposal is being mentioned that would, in fact, move stem cell funding away from the agency.

One stem cell scientist, Paul Knoepfler of UC Davis, wrote last week about the agencys presidential search.

Commenting on his blog, Knoepfler said that CIRM directors should pick a fantastic person to replace Mills. Knoepfler said the new president should have strong leadership skills, a big picture clinical vision and impeccable stem cell credentials, criteria that one could argue have not been met by most CIRM CEOs.

In the past, debate about presidential candidates centered on whether they should be stem cell stars or a leader who can execute an aggressive program that is already approved and in place. Given the current CIRM challenges, other criteria, such as speed and continuity, are also high.

The journal Nature this year said that the agency is in its last stage. CIRM directors may well have that admonition on their minds as they consider fresh leadership for the program. Sphere: Related Content Eds Note: DavidJensen is a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report, where this story first appeared. He has published more than 4,000 items on California stem cell matters in the past 11 years.

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Pros And Cons Of Stem Cell Research – Popular Issues

Monday, July 3rd, 2017

Pros and Cons of Stem Cell Research - What are Stem Cells? There has been much controversy in the press recently about the pros and cons of stem cell research. What is the controversy all about? "Stem" cells can be contrasted with "differentiated" cells. They offer much hope for medical advancement because of their ability to grow into almost any kind of cell. For instance, neural cells in the brain and spinal cord that have been damaged can be replaced by stem cells. In the treatment of cancer, cells destroyed by radiation or chemotherapy can be replaced with new healthy stem cells that adapt to the affected area, whether it be part of the brain, heart, liver, lungs, or wherever. Dead cells of almost any kind, no matter the type of injury or disease, can be replaced with new healthy cells thanks to the amazing flexibility of stem cells. As a result, billions of dollars are being poured into this new field.

Pros and Cons of Stem Cell Research - Where Do They Come From? To understand the pros and cons of stem cell research, one must first understand where stem cells come from. There are three main sources for obtaining stem cells - adult cells, cord cells, and embryonic cells. Adult stem cells can be extracted either from bone marrow or from the peripheral system. Bone marrow is a rich source of stem cells. However, some painful destruction of the bone marrow results from this procedure. Peripheral stem cells can be extracted without damage to bones, but the process takes more time. And with health issues, time is often of the essence. Although difficult to extract, since they are taken from the patient's own body, adult stem cells are superior to both umbilical cord and embryonic stem cells. They are plentiful. There is always an exact DNA match so the body's immune system never rejects them. And as we might expect, results have been both profound and promising.

Stem cells taken from the umbilical cord are a second very rich source of stem cells. Umbilical cells can also offer a perfect match where a family has planned ahead. Cord cells are extracted during pregnancy and stored in cryogenic cell banks as a type of insurance policy for future use on behalf of the newborn. Cord cells can also be used by the mother, the father or others. The more distant the relationship, the more likely it is that the cells will be rejected by the immune system's antibodies. However, there are a number of common cell types just as there are common blood types so matching is always possible especially where there are numerous donors. The donation and storage process is similar to blood banking. Donation of umbilical cells is highly encouraged. Compared to adult cells and embryonic cells, the umbilical cord is by far the richest source of stem cells, and cells can be stored up in advance so they are available when needed. Further, even where there is not an exact DNA match between donor and recipient, scientists have developed methods to increase transferability and reduce risk.

Pros and Cons of Stem Cell Research - Embryonic Cells The pros and cons of stem cell research come to the surface when we examine the third source of stem cells - embryonic cells. Embryonic stem cells are extracted directly from an embryo before the embryo's cells begin to differentiate. At this stage the embryo is referred to as a "blastocyst." There are about 100 cells in a blastocyst, a very large percentage of which are stem cells, which can be kept alive indefinitely, grown in cultures, where the stem cells continue to double in number every 2-3 days. A replicating set of stem cells from a single blastocyst is called a "stem cell line" because the genetic material all comes from the same fertilized human egg that started it. President Bush authorized federal funding for research on the 15 stem cell lines available in August 2001. Other stem cell lines are also available for research but without the coveted assistance of federal funding.

So what is the controversy all about? Those who value human life from the point of conception, oppose embryonic stem cell research because the extraction of stem cells from this type of an embryo requires its destruction. In other words, it requires that a human life be killed. Some believe this to be the same as murder. Against this, embryonic research advocates argue that the tiny blastocyst has no human features. Further, new stem cell lines already exist due to the common practice of in vitro fertilization. Research advocates conclude that many fertilized human cells have already been banked, but are not being made available for research. Advocates of embryonic stem cell research claim new human lives will not be created for the sole purpose of experimentation.

Others argue against such research on medical grounds. Mice treated for Parkinson's with embryonic stem cells have died from brain tumors in as much as 20% of cases.1 Embryonic stem cells stored over time have been shown to create the type of chromosomal anomalies that create cancer cells.2 Looking at it from a more pragmatic standpoint, funds devoted to embryonic stem cell research are funds being taken away from the other two more promising and less controversial types of stem cell research mentioned above.

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Stem cell laws – Wikipedia

Sunday, January 29th, 2017

Stem cell laws are the law rules, and policy governance concerning the sources, research, and uses in treatment of stem cells in humans. These laws have been the source of much controversy and vary significantly by country.[1] In the European Union, stem cell research using the human embryo is permitted in Sweden, Finland, Belgium, Greece, Britain, Denmark and the Netherlands; however, it is illegal in Germany, Austria, Ireland, Italy, and Portugal. The issue has similarly divided the United States, with several states enforcing a complete ban and others giving financial support.[2] Elsewhere, Japan, India, Iran, Israel, South Korea, China, and Australia are supportive. However, New Zealand, most of Africa (except South Africa), and most of South America (except Brazil) are restrictive.

The information presented here covers the legal implications of embryonic stem cells (ES), rather than induced pluripotent stem cells (iPSCs). The laws surrounding the two differ because while both have similar capacities in differentiation, their modes of derivation are not. While embryonic stem cells are taken from embryoblasts, induced pluripotent stem cells are undifferentiated from somatic adult cells.[3]

Stem cells are cells found in most, if not all, multi-cellular organisms. A common example of a stem cell is the Hematopoietic stem cell (HSC) which are multipotent stem cells that give rise to cells of the blood lineage. In contrast to multipotent stem cells, embryonic stem cells are pluripotent and are thought to be able to give rise to all cells of the body. Embryonic stem cells were isolated in mice in 1981, and in humans in 1998.[4]

Stem cell treatments are a type of cell therapy that introduce new cells into adult bodies for possible treatment of cancer, Somatic cell nuclear transfer, diabetes, and other medical conditions. Cloning also might be done with stem cells. Stem cells have been used to repair tissue damaged by disease.[5]

Because Embryonic Stem (ES) cells are cultured from the embryoblast 45 days after fertilization, harvesting them is most often done from donated embryos from in vitro fertilization (IVF) clinics. In January 2007, researchers at Wake Forest University reported that "stem cells drawn from amniotic fluid donated by pregnant women hold much of the same promise as embryonic stem cells."[4]

In 2000, the NIH, under the administration of President Bill Clinton, issued guidelines that allow federal funding of embryonic stem-cell research.[4]

The European Union has yet to issue consistent regulations with respect to stem cell research in member states. Whereas Germany, Austria, Italy, Finland, Ireland, Portugal and the Netherlands prohibit or severely restrict the use of embryonic stem cells, Greece, Sweden and the United Kingdom have created the legal basis to support this research.[6]Belgium bans reproductive cloning but allows therapeutic cloning of embryos.[1]France prohibits reproductive cloning and embryo creation for research purposes, but enacted laws (with a sunset provision expiring in 2009) to allow scientists to conduct stem cell research on imported a large amount of embryos from in vitro fertilization treatments.[1]Germany has restrictive policies for stem cell research, but a 2008 law authorizes "the use of imported stem cell lines produced before May 1, 2007."[1]Italy has a 2004 law that forbids all sperm or egg donations and the freezing of embryos, but allows, in effect, using existing stem cell lines that have been imported.[1]Sweden forbids reproductive cloning, but allows therapeutic cloning and authorized a stem cell bank.[1][6]

In 2001, the British Parliament amended the Human Fertilisation and Embryology Act 1990 (since amended by the Human Fertilisation and Embryology Act 2008) to permit the destruction of embryos for hESC harvests but only if the research satisfies one of the following requirements:

The United Kingdom is one of the leaders in stem cell research, in the opinion of Lord Sainsbury, Science and Innovation Minister for the UK.[7] A new 10 million stem cell research centre has been announced at the University of Cambridge.[8]

The primary legislation in South Africa that deals with embryo research is the Human Tissue Act, which is set to be replaced by Chapter 8 of the National Health Act. The NHA Chapter 8 has been enacted by parliament, but not yet signed into force by the president. The process of finalising these regulations is still underway. The NHA Chapter 8 allows the Minister of Health to give permission for research on embryos not older than 14 days. The legislation on embryo research is complemented by the South African Medical Research Council's Ethics Guidelines. These Guidelines advise against the creation of embryos for the sole purpose of research. In the case of Christian Lawyers Association of South Africa & others v Minister of Health & others[9] the court ruled that the Bill of Rights is not applicable to the unborn. It has therefore been argued based on constitutional grounds (the right to human dignity, and the right to freedom of scientific research) that the above limitations on embryo research are overly inhibitive of the autonomy of scientists, and hence unconstitutional.[10]

China prohibits human reproductive cloning but allows the creation of human embryos for research and therapeutic purposes.[1]India banned in 2004 reproductive cloning, permitted therapeutic cloning.[1] In 2004, Japans Council for Science and Technology Policy voted to allow scientists to conduct stem cell research for therapeutic purposes, though formal guidelines have yet to be released.[1] The South Korean government promotes therapeutic cloning, but forbids cloning.[1] The Philippines prohibits human embryonic and aborted human fetal stem cells and their derivatives for human treatment and research. In 1999, Israel passed legislation banning reproductive, but not therapeutic, cloning.[1][6]Saudi Arabia religious officials issued a decree that sanctions the use of embryos for therapeutic and research purposes.[1] According to the Royan Institute for Reproductive Biomedicine, Iran has some of the most liberal laws on stem cell research and cloning.[11][12]

Brazil has passed legislation to permit stem cell research using excess in vitro fertilized embryos that have been frozen for at least three years.[1]

Federal law places restrictions on funding and use of hES cells through amendments to the budget bill.[13] In 2001, George W. Bush implemented a policy limiting the number of stem cell lines that could be used for research.[4] There were some state laws concerning stem cells that were passed in the mid-2000s. New Jersey's 2004 S1909/A2840 specifically permitted human cloning for the purpose of developing and harvesting human stem cells, and Missouri's 2006 Amendment Two legalized certain forms of embryonic stem cell research in the state. On the other hand, Arkansas, Indiana, Louisiana, Michigan, North Dakota and South Dakota passed laws to prohibit the creation or destruction of human embryos for medical research.[13]

During Bush's second term, in July 2006, he used his first Presidential veto on the Stem Cell Research Enhancement Act. The Stem Cell Research Enhancement Act was the name of two similar bills, and both were vetoed by President George W. Bush and were not enacted into law. New Jersey congressman Chris Smith wrote a Stem Cell Therapeutic and Research Act of 2005, which made some narrow exceptions, and was signed into law by President George W. Bush.

In November 2004, California voters approved Proposition 71, creating a US$3 billion state taxpayer-funded institute for stem cell research, the California Institute for Regenerative Medicine. It hopes to provide $300 million a year.

President Barack Obama removed the restriction of federal funding passed by Bush in 2001, which only allowed funding on the 21 cell lines already created. However, the Dickey Amendment to the budget, The Omnibus Appropriations Act of 2009, still bans federal funding of creating new cell lines. In other words, the federal government will now fund research which uses the hundreds of more lines created by public and private funds.[14]

In March 2002, the Canadian Institutes of Health Research announced the first ever guidelines for human pluripotent stem cell research in Canada. The federal granting agencies, CIHR, Natural Sciences and Engineering Research Council, and Social Sciences and Humanities Research Council of Canada teamed up and agreed that no research with human IPSCs would be funded without review and approval from the Stem Cell Oversight Committee (SCOC).[15]

In March 2004, Canadian parliament enacted the Assisted Human Reproduction Act (AHRA), modeled on the United Kingdoms Human Fertilization and Embryology Act of 1990. Highlights of the act include prohibitions against the creation of embryos for research purposes and the criminalization of commercial transactions in human reproductive tissues.[16]

In 2005, Canada enacted a law permitting research on discarded embryos from in vitro fertilization procedures. However, it prohibits the creation of human embryos for research.[1]

On June 30, 2010, The Updated Guidelines for Human Pluripotent Stem Cell Research outline that:

Canada's National Embryonic Stem Cell Registry:

Australia is partially supportive (exempting reproductive cloning yet allowing research on embryonic stem cells that are derived from the process of IVF). New Zealand, however, restricts stem cell research.[17]

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Charity Watchlist – Get Involved | American Life League

Saturday, January 28th, 2017

The list of charitable research organizations and their corresponding positions on the life issues posted to our website is neither all pro-life nor all anti-life; it is mixed. Unfortunately, most of the organizations on our list are marked with the red minus sign. It is simply just a sad fact that most national medical research/advocacy groups support some form of unethical research. There is no listing, to our knowledge, of only pro-life research organizations.

A green positive/plus sign indicates that ALL considers the organization worthy of support from pro-lifers. ALL considers an organization to be pro-life if it is opposed to abortion, human embryonic stem cell and/or aborted fetal body parts research, all forms of cloning and other attacks against the human person at any stage of development as well as Planned Parenthood Federation and other pro-abortion organizations.

A red negative/minus signs indicates that ALL does not consider the organization worthy of support from pro-lifers. If the organization supports, in any way (theory, advocacy, lobbying, granting and/or research) any offenses to life, it is not considered pro-life. Further, if any organization refuses to answer our inquiries, refuses to be clear about its position and/or attempts to couch its answer in terms of referring to another agency (i.e., federal government branches), it is not considered pro-life.

A plain yellow circle indicates that ALL urges caution when considering support for the organization due to a change in a prior rating. That is, an organization may have previously received a green positive or a red negative because of certain policy positions which are now questionable or cannot be verified.

The rating is based on the organizations response to written correspondence (regular postal or e-mail), a review of the organizations website, verifiable news reports, verifiable correspondence forwarded to us by others and/or a combination of any of these.

Research into other organizations not listed is an on-going process, but may be limited by staff and resources at ALL. If you have information (and documentation) about organizations that you would like to see listed, we would be most happy to receive it. Currently, we are not in a position to print the list (it amounts to more than 100 pages, not including documentation in hyperlinks) however, feel free to pass the link to the website to everyone you know!

Alex's Lemonade Stand Foundation 333 E. Lancaster Ave Suite 414 Wynnewood, PA 19096 Phone: 866-333-1213 Fax: 610-649-3038 http://www.alexslemonade.org Liz Scott, Alex's mother and co-executive director of Alex's Lemonade Stand Foundation, stated in an e-mail to ALL in May, 2012, that: "Alex's Lemonade Stand Foundation has not funded anything even remotely related to embryonic stem cell research."

However, when it was pointed out to Mrs. Scott that, according to the Foundation's website, there were grant funds being directed toward researchers and research facilities that support, promote and conduct such research, she responded:

"Although we have not issued a public policy position, I can tell you that ALSF has always followed all federal guidelines for research that involves human-derived cells and tissues. We are very sensitive to the variety of opinions on issues related to stem cells, and are committed to funding research programs that meet all of the stringent ethical standards at the institutional, foundation and government levels, that are designed to find cures for childhood cancer. I can tell you that when we award funds to our grant recipients 100% of the funds are used for their project onlythe institution is not allowed to take any indirect costs or general operating costs from the award funds or to use funds for other projects."

ALL cautions that federal guidelines allow for both human embryonic stem cell research and the use of aborted fetal materials in research.

When contacted by email in July 2014 with an update request, someone by the name of Lisa responded:

We do not have a policy. We have never received an application that includes embryonic stem cells so this isnt an issue for us.

When asked what the organization would do if it did receive a grant application that involved the use of human embryonic stem cells or aborted fetal material, there was no further reply.

Alliance for Aging Research 1700 K Street, NW Suite 740 Washington, DC 20006 Phone: 202-293-2856 Fax: 202-955-8394 http://www.agingresearch.org The Alliance for Aging Research is a 501(c)(3) group that advocates for medical research and scientific discoveries to improve the health and independence of Americans as they age. As such, the Alliance supports public policies that advance research involving both adult and embryonic stem cells and regenerative medicine in general.

While the Alliance for Aging Research opposes efforts to copy human life through cloning technologies, it is a leader among patient groups and science advocates supporting public funding for broad activities in stem cell research as well as therapeutic cloning of compatible stem cell lines for research and potential therapies. On its own and through membership in the Coalition for the Advancement of Medical Research, the Alliance will support the enactment of legislation to encourage increased federal funding for advances in stem cell research. https://web.archive.org/web/20130907070614/http://www.agingresearch.org/content/topic/detail/?id=1018&template=position

UPDATE: July 2, 2014

In an email to ALL from Noel Lloyd, Communications Manager at AAR:

The Alliance supports public policies that advance medical research with the potential to prevent, postpone or otherwise lessen diseases and disabilities that increase with aging. This includes policy support though not direct funding of a broad scope of regenerative medicine, including research on induced pluripotent and human embryonic stem cells.

Alliance for Regenerative Medicine 525 2nd Street, N.E. Washington, DC 20002 Phone: 202-568-6240 http://www.alliancerm.org "The Alliance for Regenerative Medicine (ARM)s mission is to advance regenerative medicine by representing, supporting and engaging all stakeholders in the field, including companies, academic research institutions, patient advocacy groups, foundations, health insurers, financial institutions and other organizations."

According to the website, regenerative medicine includes cell-based therapies, gene therapy, biologics, tissue engineering, bio-banking, and stem cells for drug discovery, toxicity testing and disease modeling. It is this last branch of regenerative medicine which causes the most concern: "Companies are increasingly learning to leverage the use of stem cells and/or living tissue constructs to create in vitro models to study human mechanisms of disease and the effects of drugs on a variety of cell and tissue types such as human heart, liver and brain cells. These models, built predominantly using embryonic and induced pluripotent stem cells, allow for faster and safer drug development." (http://alliancerm.org/industry-snapshot)

Many of ARM's membersare companies, foundations, and associations with public positions of support for human embryonic stem cell research.

ALS Association (Amyotrophic Lateral Sclerosis Association) 1275 K Street, NW Suite 250 Washington, DC 20005 Phone: 202-407-8580 http://www.alsa.org In an email to ALL from Carrie Munk at the ALS Association July 2, 2014:

The ALS Association primarily funds adult stem cell research. Currently, The Association is funding one study using embryonic stem cells (ESC), and the stem cell line was established many years ago under ethical guidelines set by the National Institute of Neurological Disorders and Stroke (NINDS); this research is funded by one specific donor, who is committed to this area of research. In fact, donors may stipulate that their funds not be invested in this study or any stem cell project. Under very strict guidelines, The Association may fund embryonic stem cell research in the future.

The ALS Association also financially supports NEALS (the Northeast ALS Consortium) which performs human embryonic stem cell research:

The ALS Association Awards $500,000 to the NEALS Consortium for Its TREAT ALS Clinical Trials Network For the sixth consecutive year, The ALS Association is pleased to announce its support of the Northeast ALS Consortium (NEALS), the largest consortium of ALS clinical researchers in the world. This years award totals $500,000 and will fund new initiatives and ongoing programs that will increase the quality and efficiency of clinical trials for ALS. (www.alsa.org/news/archive/neals-consortium-award.html)

The Northeast ALS Consortium (NEALS) is an international, independent, non-profit group of researchers who collaboratively conduct clinical research in Amyotrophic Lateral Sclerosis (ALS) and other motor neuron diseases.

Study utilizing the spinal cord neural stem cells from electively aborted fetus.

Alzheimer's Association 225 N. Michigan Avenue Floor 17 Chicago, IL 60601-7633 Phone: 312-335-8700 Fax: 866-699-1246 http://www.alz.org The Alzheimers Association policy supports and encourages any legitimate scientific avenue that offers the potential to advance this goal, including human embryonic stem cell research; and, we oppose any restriction or limitation on research, provided that appropriate scientific review, and ethical and oversight guidelines and compliance are in place." http://www.alz.org/national/documents/statements_stemcell.pdf

American Cancer Society 250 Williams St., NW Atlanta, GA 30303 Phone: 800-227-2345 http://www.cancer.org The American Cancer Society is not considered a pro-life organization for the following reasons:

Support for human embryonic stem cell research

The American Cancer Society (ACS) has, for many years, insisted that the federal government remains the institution best suited to both fund and oversee research using human embryonic stem cells while claiming to fund only explorations into uses of human adult stem cells and stem cells from umbilical cord blood.

However, in August 2001, when then-President Bush signed an executive order restricting federal funding of human embryonic stem cell research to stem cell lines that were already in existence at the time, the ACS issued a statement commending the administration for allowing stem cell research to proceed, and expressed hope for its future.

The Society believes that such research holds extraordinary potential in the fight against a variety of life-threatening diseases currently afflicting an estimated 140 million Americans, the statement said. It continued, The American Cancer Society commends the Administration for allowing this vital scientific research to proceedeven in a limited way.

The American Cancer Society remains hopeful that both the government and commercial sectors will continue to work collaboratively and with an open mind to explore additional solutions that will allow for the continuation of human embryonic stem cell research as necessary and appropriate, the ACS statement concluded.

These statements can no longer be found on the ACS website, but can be viewed here: http://replay.waybackmachine.org/20030626004233/http://www.cancer.org/docroot/NWS/content/NWS_1_1x_President_Supports_Limited_Stem_Cell_Research.asp

Keep in mind that during the eight years that followed Bushs order, Congress passed legislation to expand human embryonic stem cell research and each time it was vetoed. When President Barack Obama took office in 2009, one of his first acts as president was to issue an executive order expanding the research policy. The National Institutes of Health (NIH) began funding grants in the field of human embryonic stem cell research.

No ACS grants which provide for the direct funding of human embryonic stem cell research have been identified; however, grant funding to facilities and labs where such research abounds is indeed prominent.

The American Cancer Society has, in the past, also awarded financial grants to Planned Parenthood, the nations leading provider of abortion. http://www.lifesitenews.com/news/american-cancer-society-gives-planned-parenthood-grant-money-for-just-sayin

Despite the outcry over the connection to Planned Parenthood, the ACS maintains the association. Visitors to the ACS website can type Planned Parenthood into the search field and find a number of results:

Referral to Planned Parenthood as source of information and support for testicular cancer: http://www.cancer.org/cancer/testicularcancer/moreinformation/doihavetesticularcancer/do-i-have-testicular-cancer-add-res and http://www.cancer.org/acs/groups/cid/documents/webcontent/003172-pdf.pdf

Referral to Planned Parenthood as source of information and support for cervical cancer: http://www.cancer.org/cancer/cervicalcancer/overviewguide/cervical-cancer-overview-additional

The ACS refers to Planned Parenthood as a Voluntary Health Organization which should be invited into schools: http://www.cancer.org/acs/groups/content/@nho/documents/document/keycommunityrepresentativespdf.pdf

Planned Parenthood affiliate locations are used as sites for ACS awareness activities: http://www.cancer.org/myacs/eastern/areahighlights/cancernynj-news-blue-albany

The ACS notes that use of IUDs correlate with decreased risk of cervical cancer and that multiple pregnancies correlate to increased risk. The ACS recommends the HPV vaccine (Gardasil or Ceravax). The ACS also lists Planned Parenthood Federation of America as a source of information and support concerning HPV. http://www.cancer.org/acs/groups/cid/documents/webcontent/003042-pdf.pdf

J. Diane Redd, ACS Director for Major and Planned Gifts for New Jersey is a former fundraiser for Planned Parenthood: https://www.cancer.org/involved/donate/otherwaystogive/plannedgiving/diane_redd

Mady J. Schuman, a member of ACS' executive leadership used to work for Planned Parenthood: https://www.cancer.org/involved/donate/otherwaystogive/plannedgiving/mady_schuman

Kris Kim, ACS' CEO for the Eastern Division was the associate vice president for communications at Planned Parenthood New York City: http://www.cancer.org/acs/groups/content/@eastern/documents/document/acspc-028409.pdf

Similarly, the American Cancer Society has links to another pro-hESCR/pro-abortion organizationLance Armstrongs LIVESTRONG. The ACS is listed as an ambassador to the LIVESTRONG Global Cancer Campaign in honor of Lance Armstrongs return to professional cycling (http://www.livestrong.org/Who-We-Are/Our-Strength/LIVESTRONG-Societies/Ambassadors). Ambassadors committed to donating $250,000 or more in 2009.

Lance Armstrong supports human embryonic stem cell research http://livestrongblog.org/2009/03/09/president-obama-lifts-stem-cell-funding-ban/ and the LIVESTRONG Foundation lists abortion providers on its website. http://www.livestrong.com/search/?mode=standard&search=planned+parenthood

Aside from the American Cancer Societys support for human embryonic stem cell research and questionable grant funding, it refuses to acknowledge the abortion/breast cancer link and declines to even support the idea that doctors should mention it to their patients. Source: http://www.abortionbreastcancer.com/newsletter102202.htm

Lastly, in its document on fertility in women with cancer, the ACS suggests egg freezing, embryo freezing, in vitro fertilization, egg donation, and surrogacy. http://www.cancer.org/acs/groups/cid/documents/webcontent/acspc-041244-pdf.pdf

And, in its document on fertility in men with cancer, the ACS suggests sperm banking, sperm donation and in vitro fertilization. http://www.cancer.org/acs/groups/cid/documents/webcontent/acspc-041228-pdf.pdf

American Council on Science and Health 1995 Broadway Suite 202 New York, NY 10023-5860 Phone: 866-905-2694 Fax: 212-362-4919 http://www.acsh.org The American Council on Science and Health (ACSH) is a consumer education consortium concerned with issues related to food, nutrition, chemicals, pharmaceuticals, lifestyle, the environment, and health. ACSH was founded in 1978 by a group of scientists who had become concerned that many important public policies related to health and the environment did not have a sound scientific basis. These scientists created the organization to add reason and balance to debates about public health issues and to bring common sense views to the public. http://www.acsh.org/about/

Im pleased with the courts [U.S. appeals court rules in favor of stem cell research, August 2012] decision, says ACSHs Dr. Gilbert Ross, since stem cells have such vast potential to solve currently insoluble medical problems, including illnesses such as ALS and perhaps, eventually, Alzheimers disease. Certainly, to continue scientific advances in this field, research on stem cells must not be discouraged. http://acsh.org/2012/08/u-s-appeals-court-rules-in-favor-of-stem-cell-research/

ACSH has been a fervent advocate for supporting research progress in ESCs (embryonic stem cells) for years, despite the controversy involving the objections of some to using human embryonic tissues in research. http://acsh.org/2013/07/small-step-in-stem-cell-research-a-giant-leap-for-mankind/

American Diabetes Association National Office 1701 N. Beauregard St. Alexandria, VA 22311 Phone: 800-342-2383 http://www.diabetes.org We strongly support the protection and expansion of all forms of stem cell research, which offer great hope for a cure and better treatments for diabetes. We support legislation and proposals that enhance funding for stem cell research at the federal and state levels. http://www.diabetes.org/advocacy/advocacy-priorities/funding/stem-cell-research.html#sthash.PUBLIjKV.FhjarP2n.dpuf

The American Diabetes Association applauds President Obama for issuing an Executive Order that will advance stem cell research by lifting existing restrictions on the use of embryonic stem cells, while maintaining strict ethical guidelines.

The American Diabetes Association has long been a strong advocate for ending the current restrictions on stem cell research. http://www.diabetes.org/newsroom/press-releases/2009/statement-from-the-american-2009.html

American Heart Association National Service Center 7272 Greenville Ave Dallas, TX 75231 Phone: 800-242-8721 http://www.heart.org The American Heart Association website states the following regarding stem cell research:

Stem Cell Research The American Heart Association funds meritorious research involving human adult stem cells because it helps us fight heart disease and stroke. We dont fund research involving stem cells derived from human embryos or fetal tissue.

However, it continues:

Inducing adult stem cells into a pluripotent state may lead to patient-specific cell therapies that could reduce many of the underlying complications in therapies with embryonic stem cells.

Its important for research to continue in both cell types. To know how induced adult stem cells need to perform, we must know more about the innate function of embryonic stem cells. http://www.heart.org/HEARTORG/Conditions/Research-Topics_UCM_438796_Article.jsp

American Lung Association 55 Wacker Dr., Suite 1150 Chicago, IL 60601 Phone: 312-801-7630 http://www.lung.org The American Lung Association recognizes that research with human stem cells offer significant potential to further our understanding of fundamental lung biology and to develop cell-based therapies to treat lung disease. The American Lung Association supports the responsible pursuit of research involving the use of human stem cells. http://www.lung.org/get-involved/advocate/advocacy-documents/research.pdf

American Medical Association AMA Plaza 330 N. Wabash Ave., Suite 39300 Chicago, IL 60611-5885 Phone: 80-262-3211 http://www.ama-assn.org "The principles of medical ethics of the AMA do not prohibit a physician from performing an abortion in accordance with good medical practice and under circumstances that do not violate the law." http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion201.page?

The AMA supports the legal availability of mifepristone (RU-486) for appropriate research and, if indicated, clinical practice. (Res. 100, A-90; Amended: Res. 507, A-99) http://www.ama-assn.org/ad-com/polfind/Hlth-Ethics.pdf

The AMA reaffirms its position in support of the use of fetal tissue obtained from induced abortion for scientific research. (Res. 540, A-92; Reaffirmed: CSA Rep. 8, A-03) http://www.ama-assn.org/ad-com/polfind/Hlth-Ethics.pdf

Our AMA (1) supports continued research employing fetal tissue obtained from induced abortion, including investigation of therapeutic transplantation; and (2) demands that adequate safeguards be taken to isolate decisions regarding abortion from subsequent use of fetal tissue, including the anonymity of the donor, free and non-coerced donation of tissue, and the absence of financial inducement. (Res. 170, I-89; Reaffirmed by Res. 91, A-90; Modified: Sunset Report, I-00) http://www.ama-assn.org/ad-com/polfind/Hlth-Ethics.pdf

American Parkinson's Disease Association National Office 135 Parkinson Avenue Staten Island, NY 10305 Phone: 800-223-2732 Fax: 718-981-4399 http://www.apdaparkinson.org "We were very pleased on September 28, 2010 that the DC Circuit Court of Appeals issued a stay of the preliminary injunction pending its review of the appeal of the judicial challenge to federal funding for human embryonic stem cell (hESC) research. Without getting mired down in all the various terms and courts, what this means is that federal funding for hESC research will continue at least for the time period that it takes for the Court of Appeals to review Judge Lamberth's August 23rd decision to enjoin funding. You should also know that yesterday the Coalition for the Advancement of Medical Research (CAMR), of which PAN is a founding member, filed an amicus brief in the District Court. This brief supports and compliments the Department of Justice (DoJ) brief that was filed on behalf of the National Institutes of Health (NIH) on Monday."

[Department of Veteran Affairs and APDA Winter 2011 Parkinson Press Newsletter] http://bit.ly/1nsENqi

American Red Cross 2025 E. Street NW Washington, DC 20006 Phone: 202-303-4498 http://www.redcross.org A report issued from the International Federation of the Red Cross and Red Crescent in December of 2011 caused concerns that the organization may start advocating for abortion rights.

In a section of the report on human rights, IFRC quotes a widely criticized document issued by Anand Grover, the UN Special Rapporteur on the Right to Health, which said,

"States must take measures to ensure that legal and safe abortion services are available, accessible, and of good quality." The IFRC report goes on to editorialize, "But the real challenge is to find out how many states will indeed change their policies accordingly.

This may lead some to believe IFRC could eventually declare abortion a human right as Amnesty International did in 2007. Amid much controversy, Amnesty International simply announced that endorsing abortion as a right was a "natural" outgrowth of its 2-year campaign countering violence against women. http://www.c-fam.org/fridayfax/volume-14/analysis-is-the-red-cross-about-to-declare-abortion-a-human-right.html.

There have been no further developments in this area.

The American Red Cross has no formal public policy statements that we could find on life issues. It should be noted, however, that the American Red Cross has been under intense scrutiny and has been sued repeatedly by federal regulators to force improvements in blood safety. http://www.forbes.com/sites/gerganakoleva/2012/01/17/american-red-cross-fined-9-6-million-for-unsafe-blood-collection/

The American Red Cross also has a Diversity Program which officially recognizes and encourages participation in Gay and Lesbian Pride Month. American Red Cross Fires Employee for Refusal to Celebrate 'Gay and Lesbian Pride Month,' LifeSiteNews, August 5, 2005

American Spinal Injury Association 2020 Peachtree Road, NW Atlanta, GA 30309 Phone: 404-355-9772 Fax: 404-355-1826 ASIA_Office@shepherd.org http://asia-spinalinjury.org/ ASIA is a multidisciplinary organization whose membership is composed of physicians and allied health professionals specifically involved in spinal cord injury management. Current membership numbers 452 of which 85% are physicians. The remaining 15% are nurses, therapists, psychologists and other allied health professionals.

ASIA positions on the life topics are not clear; ALL is awaiting a response to our inquiry.

American Thoracic Society 25 Broadway New York, NY 10004 Phone: 212-315-6498 http://www.thoracic.org The American Thoracic Society (ATS) is an organization dedicated to serving patients with lung disease through research, advocacy, training, and patient care. As such, it supports making federal funding available for research using human embryonic stem cells with appropriate guidelines and federal and institutional oversight.

. . . [adult stem cell research] approaches should neither distract from nor preempt research for which the goal is to assess the use of pluripotent embryonic stem cells for the treatment of lung diseases. http://www.thoracic.org/statements/resources/research/stemcell.pdf

Amnesty International US 5 Penn Plaza New York, NY 10001 Phone: 212-807-8400 http://www.amnestyusa.org Amnesty International defends access to abortion for women at risk In April 2007, Amnesty International changed its neutral stance on abortion to supporting access to abortion in cases of rape and incest, and when the life or the health of the mother might be threatened. Amnesty's official policy is that they "do not promote abortion as a universal right" but "support the decriminalisation of abortion". http://www.amnesty.org/en/library/asset/POL30/012/2007/en/c917eede-d386-11dd-a329-2f46302a8cc6/pol300122007en.pdf

Amnesty International Continues Pushing Abortion Worldwide (2013) Amnesty International, a human rights organization that used to be abortion neutral, is now using the problem of maternal mortality to advocate for abortion. In a new report, ostensibly on medical care for maternal health, Amnesty calls on governments to repeal abortion laws and conscience protection for medical workers who may object. They also call for public health systems to train and equip health care providers to perform abortions.

Amnestys Maternal Health is a Human Right campaign focuses attention on four countries: Sierra Leone, Burkina Faso, Peru, and the United States. Amnesty argues that maternal mortality will decrease if it is treated as a human rights issue, if costs to health care are covered by governments, and if a right for women to control their reproductive and sex lives is established. http://www.lifenews.com/2012/08/09/amnesty-international-continues-pushing-abortion-worldwide/ http://www.amnestyusa.org/our-work/campaigns/demand-dignity/maternal-health-is-a-human-right

Amnesty International Launches New Campaign to Push Abortion Worldwide (2014) Amnesty International has been under fire for years for its pro-abortion positions and now the venerable human rights group is launching a new global effort to push abortion on a worldwide scale. The My Body My Rights campaign encourages young people around the world to know and demand their right to make decisions about their health, body, sexuality and reproduction without state control, fear, coercion or discrimination. It also seeks to remind world leaders of their obligations to take positive action, including through access to health services, the group says. http://www.lifenews.com/2014/03/10/amnesty-international-launches-new-campaign-to-push-abortion-worldwide/

"Amnesty International believes that everyone should be free to make decisions about if, when and with whom they have sex, whether or when they marry or have children and how to best protect themselves from sexual ill-health and HIV." http://www.amnesty.org/en/news/sexual-and-reproductive-rights-under-threat-worldwide-2014-03-06

Avon Foundation for Women 777 Third Avenue New York, NY 10017 Phone: 866-505-2866 http://www.avonfoundation.org The Avon Foundation for Women is a 501(c)(3) public charity founded in 1955 with the mission to promote or aid charitable, scientific, educational, and humanitarian activities, with a special emphasis on those activities that improve the lives of women and their families. In its work to realize those aspirations, the Foundations current mission focus is to lead efforts to eradicate breast cancer and end domestic and gender violence.

The Avon Breast Cancer Crusade was established in 1992. Since then, more than $815 million has been raised for breast cancer awareness and education, screening and diagnosis, access to care, support services and scientific research. Beneficiaries range from leading cancer research centers to local, nonprofit breast health programs, creating a powerful international network of research, medical, social service, and community-based breast cancer organizations.

The Avon Foundation is one of many breast cancer research fundraising groups that has yet to acknowledge the link between abortion and breast cancer.

While the Avon Foundation does not direct grant funding to Planned Parenthood, the more detailed answer on its website seems to indicate that it mightif it received a grant request that met its criteria.

Q: Does the Avon Foundation for Women support Planned Parenthood?

Our records indicate that in the last five years the Avon Foundation has received only one Planned Parenthood affiliate grant application from among more than an estimated 3,000 grant applications received during that time period, and it was not among our funded applicants. Our grant programs are highly competitive and unfortunately we receive many more quality applicants than available funds can support. Our Safety Net Program, Avon Breast Health Outreach Program and eight Avon Breast Health Centers of Excellence provide more than $15 million annually to address the needs for education, screening and treatment programs for underserved and uninsured women. http://www.avonfoundation.org/press-room/avon-foundation-for-women-response-to-recent-inquiries-about-breast-cancer-funding-support.html

The Speak Out Against Domestic Violence program was launched in the U.S. in 2004 and global expansion began shortly thereafter, with programs now in Central and South America and Europe. The Speak Out mission focuses on raising funds and awareness for domestic violence awareness, education and prevention programs while developing new community outreach and support for victims, and there is a special focus on supporting programs that assist children affected by domestic violence. Already more than $38 million has been awarded to over 250 organizations in the U.S.

In 2008, Avon Products, Inc. and the Avon Foundation introduced the company's first-ever global fundraising product, the Women's Empowerment Bracelet, designed to save and improve women's lives worldwide. The bracelet was unveiled by Avon Foundation Honorary Chair Reese Witherspoon at the second annual Global Summit for a Better Tomorrow, presented by the United Nations Development Fund for Women (UNIFEM) in partnership with Avon, at the United Nations in celebration of International Women's Day. Since then an entire catalog of fundraising products has been created.

UNIFEM is the United Nations Development Fund for Women. Established in 1976, it is self-described as fostering womens empowerment and gender equality and helping to make the voices of women heard at the United Nations. Two international agreements form the framework for UNIFEMs mission and goals: The Beijing Platform for Action and the Convention on the Elimination for All Forms of Discrimination Against Women (CEDAW).

In 1995, the Beijing Platform for Action (Beijing Platform) expressly called upon governments to reexamine restrictive abortion laws that punish women. By linking womens health to abortion law reform, the Beijing Platform affirmed what [pro-abortion] advocates [believe] worldwide: removing legal barriers to abortion saves womens lives, promotes their health, and empowers women to make decisions crucial to their well-being.

The Beijing mandate also reflects a global trend toward abortion law liberalizationa trend that first gained momentum in the late 1960s and continues to this day. http://reproductiverights.org/sites/default/files/documents/pub_bp_abortionlaws10.pdf

CEDAW, created in 1979, is actually a global Equal Rights Amendment. CEDAW mandates gender re-education, access to abortion services, homosexual and lesbian rights, and the legalization of voluntary prostitution as a valid form of professional employment. http://www.heritage.org/research/reports/2001/02/how-un-conventions-on-womens http://frcblog.com/2010/03/abortion-the-united-nations-and-cedaw/

See also http://www.all.org/newsroom_judieblog.php?id=2043.

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