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Ethical and legal issues and the "new genetics" | The …

Wednesday, June 27th, 2018

In recent years there has been an explosion of knowledge in the science of genetics but often less general awareness of the ethical and legal implications of genetic advances. Fueled by sensationalist media reporting, developments are often exaggerated and create unrealistic expectations for the "new genetics".1 Medicine has a great capacity to test and screen for gene mutations, but currently little ability to cure the clinical consequences of these mutations. Because of the newness of this information, and the deterministic way in which many interpret the data, there is a risk that predictive genetic information will be misunderstood and too much weight will be placed on it.1 Genetic determinism is particularly unwelcome, because most common diseases involve the interaction of predisposing genes with a facilitative environment the value of genetic knowledge is usually to allow accurate environmental or pharmacological intervention.

Concerns have been raised about the misuse of genetic information, particularly with computerisation and linkage of health records.2 These concerns may reduce the willingness of individuals to undergo genetic testing, even when the tests are clearly beneficial. In a recent initiative in Victoria, only a small proportion of people offered free gene screening for haemochromatosis accepted the test. One can only speculate as to the reasons for this low uptake, but fears about confidentiality and potential misuse of the information may have played some part.3,4 This was in spite of the fact that the clinical consequences of haemochromatosis can be completely averted if appropriate action is taken. Furthermore, a unique agreement had been reached with the Investment Financial Services Association (IFSA), the peak body of the life insurance industry in Australia, that people who tested positive for haemochromatosis and agreed to take preventive measures (regular blood donation) would not be refused life insurance or have their premiums loaded because of their genetic status.5

In many cases, ethical concerns about genetics simply underscore existing concerns about marginalisation, stigmatisation and discrimination of disadvantaged groups. Although these concerns may be valid, they are not new or unique to genetics. However, the sheer scope of genetics and the complex nature of genetic information, extending beyond individuals, mean that these concerns are now more pressing. There are also some significant new ethical and legal issues emerging from the application of the human genome project to medicine, particularly with regard to predictive information about common diseases and for traits (such as criminality or ability) that are not diseases at all.

Our aim in this article is to give a broad overview of the main ethical and legal challenges presented by the new genetics and their implications for the medical profession. In many instances, these issues have not been resolved and the full debate remains to be had. Typically, there are no easy answers to the dilemmas raised, but awareness of what the key issues are and sketching of directions will help healthcare professionals understand and participate in these developments.

Some basic principles to keep in mind when considering ethics are presented in Box 1. In Australia, ethics usually revolves around informed choices by individuals. However, the pervasive and predictive nature of genetic information means that every clinician has to be familiar not only with its clinical significance, but also the ethical implications.7 As well as thinking of patients as individuals, doctors must think of families, because gene analyses affect parents, siblings, children, the unborn, and sometimes entire ethnic groups. Doctors must be aware that this responsibility to family may conflict with the individual's right to privacy.

There are some fairly straightforward ethical issues that arise with respect to genetics:

Is the application of genetics lawful? If it is not, it cannot be offered, as is the case for using DNA to select the sex of an embryo in Victoria, except to avoid transmission of a genetic disorder.8 Even if it is lawful, do you, as a doctor have an ethical objection to this test or procedure, such that you would have to advise the patient to see another doctor?

Is it safe? If it can cause harm, is the likely harm balanced by the likely benefit?

Is it helpful in dealing with the problems you perceive as relevant to this patient, this family? Is it helpful in dealing with the problems as perceived by them?

Is it evidence-based, or still a research procedure?

Is it cost-effective?

These types of issues arise with every medical procedure, but arise with an unprecedented intensity for genetics.

The availability of genetic testing offers the "capacity to know" about one's genetic destiny with greater certainty than revealed by family history alone, but knowledge will not always be welcome and individuals are generally at liberty to decide whether they want this information. The ethics of testing are different if action can be taken to prevent or treat a disease, as for haemochromatosis, as compared with conditions for which no treatments are presently available, such as Huntington disease. If prevention or early treatment is available, it is unethical not to offer testing. However, some people want and use knowledge even if there is no treatment, for example, for reproductive choice. Particular care needs to be taken with the predictive genetic testing of children: this is widely regarded as inappropriate unless preventive strategies are available.9,10

The capacity to use test data for reproductive choice brings a range of ethical dilemmas. Genetic testing of fetuses with a view to termination of pregnancy is met with alarm by some disability advocates, who are concerned about approaches that treat disability as a "problem" that should be prevented using genetic means, rather than dealing with the issue of non-discrimination of people with disabilities.11 Concerns have been expressed that the range of conditions that may be tested for will extend to good looks and abilities, leading to fears of "designer babies" and the spectre of eugenics.

Society will set the limits within which choices will be made. Although there is some disquiet about genetic interventions, as a society we need to ensure that we have a balanced ethical debate on issues of concern and that we distil the real ethical issues. The challenge ahead is to ensure that the newness of genetics does not unreasonably impede its implementation. There may be a natural resistance to the expansion of genetic science and technology, particularly where it extends beyond the therapeutic model (eg, to enhance appearance or intelligence), but it is important that we not limit the available options unless there is sound justification for doing so. This also underscores the importance of offering appropriate genetic counselling, particularly for the more complex situations in predictive or prenatal testing, so that individuals can make informed choices in both an individual and a social context.

The law needs to set limits within which scientific development and clinical practice can operate. Although the scope and extent of protection that should be provided by the law is a matter for debate, there is consensus that the law should protect individuals from avoidable harm.

The metaphor of the law "limping in the rear" of the march of science12 is often invoked, and nowhere more so than in the context of the new genetics. There are few laws in Australia regulating the collection and use of personal genetic information, and none that do so explicitly for genetic information. The present legal framework in this area consists primarily of anti-discrimination and privacy legislation. We end up with a complex legislative patchwork, which has some influence on the permissible collection and use of personal human genetic information, but does not effectively "regulate" it. For this reason, there has been much agitation for reform to respond to the new challenges created by the increase in the range of available genetic testing.

The collection and use of human genetic information, and the measures that may be necessary to protect the individual are under intense scrutiny by the Australian Law Reform Commission (ALRC) and the Australian Health Ethics Committee (AHEC).13 A discussion paper released in August 2002 canvasses a range of issues and makes numerous proposals for regulation.14 These are being finalised for public discussion and possible enactment.

The availability of the new genetics has implications with regard to doctors' legal duty of care to their patients. Doctors have a responsibility to keep up to date with the new genetics so that they can give advice on what tests are available. As with any medical procedure, the law protects the autonomy of competent individuals to decide whether to undergo genetic testing and to accept medical treatment or advice about lifestyle changes arising from such testing. However, there are tensions between the rights of individuals and the rights of the family, for whom this information may have relevance to health. Privacy regulation in Australia comprises a combination of common law and legislation.15 At present, no special status is afforded to genetic information. Strictly, even taking a person's family history involves a potential breach of the privacy of other family members. This difficulty has now been addressed through the Federal Privacy Commissioner making a Public Interest Determination to cover family medical histories.16

Problems can also arise with the disclosure of an individual's genetic information to other family members. At present, standard rules regarding the disclosure of health information apply, limiting disclosure to circumstances where there is a threat of serious and imminent harm to others or a serious public health risk.17 However, the familial nature of genetic information demands some modification of the usual principles of privacy and non-disclosure, in both directions. The information should be able to be shared with family members whose health may benefit from access to this information by alerting them to the risk of genetic disease and enabling them to institute preventive or therapeutic strategies,18 but be protected more carefully from outsiders. One aspect of the ALRC/AHEC proposals that is likely to be of practical relevance to doctors is the proposal to expand the circumstances in which genetic information may be released to other family members.14

There are also vexing questions about whether third parties should be entitled to access personal genetic information. When applying for insurance, individuals are required to disclose family history and the results of any genetic tests,19 and insurers are entitled to take this information into account for the purposes of underwriting for life insurance and related products. Insurers are exempt from disability discrimination,20 but must be able to justify the way in which they use the genetic information with regard to actuarial, statistical or other data. There are concerns about the adequacy of available data for underwriting purposes and the potential for unfair genetic discrimination (Box 2).22 In several jurisdictions, including the United Kingdom, moratoriums have been introduced on the use of genetic test information by insurers, or such use has been prohibited by legislation. Current proposals for reform put forward by the ALRC/AHEC retain the insurers' entitlement to use genetic test information for risk assessment, but seek to regulate more stringently what genetic tests can be used by devolving this responsibility to the proposed Human Genetics Commission of Australia.14

In the sphere of employment, the challenge is to ensure that legitimate uses of genetic test information are permitted, such as offering screening for susceptibility to workplace hazards that cannot otherwise be avoided, but to protect employees and job seekers from unfair discrimination motivated by employers' expediency and profit. The proposals advanced by the ALRC/AHEC seek to strike a proper balance to allow uses of genetic testing which are consistent with occupational health and safety interests, but prohibit other uses.14

Fundamental questions are also being raised about the status of genetic samples collected for pathology examination, such as blood or other sources of DNA, including pathological tissue blocks and human tissue on microscope slides. At present, these are generally regarded as the property of the hospital, over which the donor may have no legally enforceable rights. Although such samples have no clear legal status as property, opinions are divided over whether it is appropriate to create legally enforceable rights, especially if the sample proves to have a commercial value.23,24 The line between research and clinical care is ethically blurred when a sample is studied by a specialist or a pathologist, and becomes even more confusing as we move towards an increasingly commercialised environment in which the potential for profit from genetic knowledge is real and the clamour for patents resonates.25

When it comes to regulation of artificial reproductive technology, the situation is even more confused. In Victoria, South Australia and Western Australia, there is legislation regulating this area.26-28 These Acts, to varying degrees, restrict the circumstances in which genetic testing can be undertaken. The other States and Territories have no legislation, and this lack of uniformity invites "doctor shopping".29

There is great concern that genetics will be used for "designer babies", but no one knows whether this will be possible, economically viable, or wanted by anyone. Couples are now being allowed to choose pregnancies that will provide an infant with a particular genetic make-up in the context of a sibling with a very serious illness.30 The baby can then be a donor of cord blood stem cells to the seriously ill sibling. Although this is occasionally described as "designer babies", it is clearly far from what concerns the public. It is important for doctors to be aware of and emphasise the difference between the use of clinical interventions to save the lives of children with serious diseases, as compared with the use of procedures for trivial purposes such as choosing hair or eye colour. The former is generally thought to be ethical, the latter unethical. There is concern that over-the-counter DNA tests will soon be available, but knowledge has for generations been regarded as a positive, not a negative, commodity. Doctors may be the gatekeepers of the new genetic knowledge, but they will not be its owners.

The draft sequence of the human genome is now on the Web, and advances in our understanding of the relationships between genes and environment and disease occur almost daily. Challenging issues lie on the horizon in terms of defining the role of doctors with respect to their patients and the extent of their duty of care, as we learn more of the relationship between genes, the environment and complex diseases and behaviours. Because of community concerns, there will be pressure for laws to regulate the application of genetics in medicine. However, knowledge of genetics and the methods of applying it to people are changing rapidly, so there is an overwhelming need for flexibility in the development of solutions. This may encourage the use of regulations and other "soft" laws, such as guidelines and codes of practice, in preference to statute law, as the former are easier to adapt to new situations.

The new genetics has enormous potential to confer clinical benefits. The challenge is to harness these benefits and to minimise the risk of harm. Fortunately, most doctors, patients and families want to make sensible choices. The ethical interpretations we offer, and the legal framework that is used to interpret these ethical principles, must ensure that application of the new genetics is not unreasonably restricted as it develops. The better informed doctors are of the ethical and legal issues arising from the new genetics, the better equipped they will be to give appropriate information to patients and the community.

1: Ethical principles

There are many religions and belief systems, and it is important that healthcare ethics should be able to inform decisions of the whole community. Four principles that could underpin an ethical approach to healthcare issues are: 6

1. Respect autonomy: educate, communicate, consult, respect and empower. (Autonomy is both very important and controversial in genetics. Conflict between the rights of the individual, the family and the community arise more often for genetic issues than for most medical procedures.)

2. Beneficence: provide net benefits, but ensure these are realistic.

3. Non-maleficence: do no avoidable harm, to individuals or groups.

4. Promote justice: fair distribution of resources, respect for rights and respect for morally acceptable laws. (One problem of genetics is that it "is not fair". We are not "created equal", because our genetics differs, and with it our health risks. However, the doctor has to try to create a level playing field, in the interests of justice.)

When applied in the context of genetics, beneficence and non-maleficence sit easily, but, for the reasons noted above, autonomy and justice are problematic.

2: Genetic discrimination

Genetic discrimination can be defined as different treatment of an individual by a third party such as an insurer or employer on the basis of genetic factors real, inferred or wrongly imputed. Discrimination can be positive or negative: the concerns relate to unfavourable discrimination, involving decisions adverse to the interests of the individuals involved. Unfavourable discrimination can be justifiable and lawful: anti-discrimination legislation, which provides protection for some forms of unfair discrimination, contains exemptions from discrimination by insurers and employers in some circumstances.

A team of researchers, funded by the Australian Research Council, is conducting a major empirical study into the nature and extent of genetic discrimination in Australia and its social and legal implications.21 The study seeks to gain the experience and perspective of all key stakeholders: "consumers" (those considered to be at risk because of a genetic test result or their family history); third parties such as insurers and employers (the groups against which allegations of genetic discrimination have most frequently been made); and the various organisations within the legal system through which complaints of alleged genetic discrimination may be pursued.

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Health-Care Issues Remain – The Central New York Business Journal

Thursday, September 7th, 2017

Nobody knew that health care could be so complicated. President Donald Trump

I was shocked by the quote above from our president, who made thisstatement in February 2017, soon after being inaugurated. As you all know, this statement was followed by six months of political debate over the repeal and replacement of Obamacare, also known as the Affordable Care Act. Contrary to the presidents statement, virtually anyone that has any connection to the U.S. health-care system knows that it is extraordinarily complicated. Medical professionals, health-system employees, patients, suppliers, vendors, and the majority of the citizenry would clearly disagree with the presidents statement that nobody knew.

This past six months, I have debated with myself whether a column related to health-care reform would be of value. After considerable thought and reflection, I realized that the following column, originally published in the Rochester Business Journal in January 2005, was as relevant today as it was then. As you read the following, it will be clear that the health-care debate has been a subject in political football since the enactment of the Medicare and Medicaid programs in 1965. As you read, remember that I did not have to change one word of what I published in the column some 12 years ago.

January 2005 column

Our health-care cost crisis is of our own making. Before launching into my health-care solutions agenda, please be advised that my opinions are predicated on a foundation of irrefutable assumptions.

All people are created equalNo human being is immortalWe live in a capitalist, not socialist, economyEvery individual has a right to access health-care servicesSocioeconomic factors create inequality in wealth distributionHealth-care cost is of legitimate concernThe vocal majority rules in health-care decision-makingThere is no such thing as unanimous support for health-care policy decisions

With these baseline assumptions, allow me to articulate a 10-point program for improving the cost-effectiveness of our communitys health-care system. Even though I must admit a fiscal bias due to my profession, the quality of health care is of equal importance in addressing these potential solutions. Also, I never intend to run for political office, and these opinions will ensure that I could never be elected.

With all due respect to myriad interest groups and health-care lobbies, here is Archibalds Top 10 list, in David Letterman format, with no humor intended:

10. Controllable behaviors that negatively impact an individuals health should be reflected as an increased cost in insurance premiums. If I smoke two packs a day, I should pay more. Abuse of controllable behaviors costs more in life and automobile insurance, why not health care? Tobacco and alcohol companies, beware.

9. Tort reform and caps on personal injury, pain and suffering awards are a legislative requirement. Maine took the first step in what I hope will be a trend in limiting awards in the litigation area. One of the platform issues of the new administration that I agree with is tort reform.

8. Successful reform of the health-care legal system should allow providers to immediately reduce costs associated with defensive medicine. The costs of unnecessary visits, tests, and procedures ordered by service providers to reduce the potential risk of litigation total billions of dollars each year. And malpractice-insurance-premium decreases will be an ancillary benefit.

7. Reintroduce the consumers wallet into health-care access and decision-making. If an individual wants to access health-care services, there should be a direct cost to the consumer, subject to income limitations. The recent adoption of health-savings accounts as an incentive for employers and employees to take control of escalating health-care costs is a paradigm shift in our governments attitude towards health care. Health-care costs are virtually invisible to consumers, and a Wegmans vs. Tops price comparison would certainly affect costs. If you want proof, look at the declining cost trends for Lasik surgery procedures.

6. Reduce the level of administrative and regulatory compliance costs in health care. Depending upon the study, costs in these areas consume up to 26 percent of every health-care dollar. The potential savings are enormous.

5. Technology advancement is wonderful and our nations research industry is the finest in the world. However, technology advances frequently increase costs through obsolescence of existing equipment and the incremental cost to providers of adding the new technology. This area may be one of the most difficult to address since any control mechanism that limits new technology must be balanced with appropriate incentives for research initiatives.

4. Controls over the drug manufacturers and pharmaceutical suppliers must be established. The efficacy of drug therapies must be assessed. Blatant and excessive advertising by the pharmaceutical industry to a public that is largely not responsible for the drug cost must be reined in. The final three items on my list are the most controversial of all. If I havent lost your vote yet, I am confident that the Big Three will push you to pull another lever.

3. Health-care capacity must be addressed through a local community effort. The debate is not about either competition or cooperation but, as Deion Sanders once said, I want both. Health-care delivery in this country is largely controlled by local communities. Competition among service providers is an essential element of health-care cost and quality in every community. Leadership without bias is a necessity for success in this area.

2. Establishing standards for patients expectations of their right to access health care, both basic and advanced, is a necessity. The research discoveries on the near horizon from genetic mapping will create new opportunities and make obsolete existing equipment and facilities. Bioethical debate must address the essential question of, Who is entitled to what and at what cost?

1. End-of-life care must be addressed. We are making progress in this area with health-care proxies, palliative-care initiatives, and other planning processes. However, its staggering to know that the majority of your lifetime health-care costs will be spent in the last year of your life.

Health-care spending is approaching 15 percent of our gross domestic product. The baby boom generation, of which I am a proud member, is beginning to retire. The health-care issues we face as a community and a country are overwhelming.

As CEO of Excellus, the dominant insurer in our community, David Kleins piece in the Dec. 19, 2004, edition of the daily newspaper was of interest. He stated: A healthier community is fostered when its business leaders, physicians and other health service providers are included in the dialogue and when these professionals work in an environment that has its major health service and financing organizations working more cooperatively and with a focus on community benefit. While this quote is a mouthful of words, action in support of this philosophy is what is needed.

Each of us must look in the mirror. A realistic assessment of our mortality and myriad issues that must be addressed is imperative. True innovation and industry reform can be a reality in health care.

Ignoring the debate and compromise necessary will only make matters worse.

The only modification to the 2005 column is that health-care costs now represent 18 percent of our gross domestic product. It is truly fascinating to me how little has been accomplished in the past 12 years. We can only hope that the future will bring rational reforms that address each of the major issues discussed in my 2005 column.

Gerald J. Archibald, CPA, is a partner in charge of the management advisory services at The Bonadio Group. Contact him at (585) 381-1000, or email: garchibald@bonadio.com

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Profit Maximization is Easy: Invest in Violence – Pressenza International Press Agency

Wednesday, September 6th, 2017

For those of us committed to systematically reducing and, one day, ending human violence, it is vital to understand what is causing and driving it so that effective strategies can be developed for dealing with violence in its myriad contexts. For an understanding of the fundamental cause of violence, see Why Violence?

However, while we can tackle violence at its source by each of us making and implementing My Promise to Children, the widespread violence in our world is driven by just one factor: fear or, more accurately, terror. And I am not talking about jihadist terror or even the terror caused by US warmaking. Let me explain, starting from the beginning.

The person who is fearless has no use for violence and has no trouble achieving their goals, including their own defence, without it. But fearlessness is a state that few humans would claim. Hence violence is rampant.

Moreover, once someone is afraid, they will be less likely to perceive the truth behind the delusions with which they are presented. They will also be less able to access and rely on other mental functions, such as conscience and intelligence, to decide their course of action in any context. Worse still, the range of their possible responses to perceived threats will be extremely limited. And they will be more easily mobilised to support or even participate in violence, in the delusional belief that this will make them safe.

For reasons such as these, it is useful for political and corporate elites to keep us in a state of fear: social control is much easier in this context. But so is profit maximization. And the most profitable enterprise on the planet is violence. In essence then: more violence leads to more fear making it easier to gain greater social control to inflict more violence. And starting early, by terrorizing children, is the most efficient way to initiate and maintain this cycle. See Why Violence? and Fearless Psychology and Fearful Psychology: Principles and Practice.

So, for example, if you think the massive number of police killings of innocent civilians in the United States see Killed by Police and The Counted: People killed by police in the US is a problem, you are not considering it from the perspective of maintaining elite social control and maximizing corporate profit. Police killings of innocent civilians is just one (necessary) part of the formula for maintaining control and maximising profit.

This is because if you want to make a lot of money in this world, then killing or exploiting fellow human beings and destroying the natural world are the three most lucrative business enterprises on the planet. And we are now very good at it, as the record shows, with the planetary death toll from violence and exploitation now well over 100,000 human beings each day, 200 species driven to extinction each day and ecological destruction so advanced that the end of all life (not just human life) on Earth is postulated to occur within decades, if not sooner, depending on the scenario. See, for example, The End of Being: Abrupt Climate Change One of Many Ecological Crises Threatening to Collapse the Biosphere.

So what forms does this violence take? Here is a daily accounting.

Corporate capitalist control of national economies, held in place by military violence, kills vast numbers of people (nearly one million each week) by starving them to death in Africa, Asia and Central/South America. This is because this economic system is designed and managed to allocate resources for military weapons and corporate profits for the wealthy, instead of resources for living.

Wars kill, wound and incapacitate a substantial number of civilians, mostly women and children, as do genocidal assaults, on a daily basis, in countries all over the planet. Wars also kill some soldiers and mercenaries.

Apart from those people we kill every day, we sell many women and children into sexual slavery, we kidnap children to terrorise them into becoming child soldiers and force men, women and children to work as slave labourers, in horrific conditions, in fields and factories (and buy the cheap products of their exploited labour as our latest bargain).

We condemn millions of people to live in poverty, homelessness and misery, even in industrialized countries where the refugees of western-instigated wars and climate-destroying policies are often treated with contempt. We cause many children to be born with grotesque genetic deformities because we use horrific weapons, like those with depleted uranium, on their parents. We also inflict violence on women and children in many other forms, ranging from ordinary domestic violence to genital mutilation.

We ensnare and imprison vast numbers of people in the police-legal-prison complex. See The Rule of Law: Unjust and Violent. We pay the pharmaceutical industry and its handmaiden, psychiatry, to destroy our minds with drugs and electro-shocking. See Defeating the Violence of Psychiatry. We imprison vast numbers of children in school in the delusional belief that this is good for them. See Do We Want School or Education? And we kill or otherwise exploit animals, mostly for human consumption, in numbers so vast the death toll is probably beyond calculation.

We also engage in an endless assault on the Earths biosphere. Apart from the phenomenal damage done to the environment and climate by military violence: we emit gases and pollutants to heat and destroy the atmosphere and destroy its oxygen content. We cut down and burn rainforests. We cut down mangroves and woodlands and pave grasslands. We poison the soil with herbicides and pesticides. We pollute the waterways and oceans with everything from carbon and nitrogenous fertilizers to plastic, as well as the radioactive contamination from Fukushima. And delude ourselves that our token gestures to remedy this destruction constitutes conservation.

So if you are seeking work, whether as a recent graduate or long-term unemployed person, then the most readily available form of work, where you will undoubtedly be exploited as well, is a government bureaucracy or large corporation that inflicts violence on life itself. Whether it is the military, the police, legal or prison system, a weapons, fossil fuel, banking, pharmaceutical, media, mining, agricultural, logging, food or water corporation, a farm that exploits animals or even a retail outlet that sells poisonous, processed and often genetically-mutilated substances under the label food see Defeating the Violence in Our Food and Medicine you will have many options to help add to the profits of those corporations and government services that exist to inflict violence on you, your family and every other living being that shares this biosphere.

Tragically, genuinely ethical employment is a rarity because most industries, even those that seem benign like the education, finance, information technology and electronics industries, usually end up providing skilled personnel, finance, services or components that are used to inflict violence. And other industries such as those in insurance and superannuation, like the corporate banks, usually invest in violence (such as the military and fossil fuel industries): it is the most profitable.

So while many government bureaucracies and corporate industries exist to inflict violence, in one form or another, they can only do so because we are too scared to insist on seeking out ethical employment. In the end, we will take a job as a teacher, corporate journalist or pharmaceutical drug pusher, serve junk food, work in a bank, join the police or military, work in the legal system, assemble a weapons component rather than ask ourselves the frightening questions Is this nonviolent? Is this ethical? Does it enhance life?

And yes, I know about structural violence and the way it limits options and opportunities for those of particular classes, races, genders. But if ordinary people like us dont consider moral issues and make moral choices, why should governments and corporations?

Moral choices? you might ask in confusion. In this day and age? Well, it might seem old-fashioned but, in fact, while most of us have been drawn along by the events in our life to make choices based on such considerations as self-interest, personal gain and financial security, there is a deeper path. Remember Gandhi? True morality consists not in following the beaten track, but in finding the true path for ourselves, and fearlessly following it.

Strange words they no doubt sound in this world where our attention is endlessly taken by all of those high-tech devices. But Gandhis words remind us that there is something deeper in life that the violence we have suffered throughout our lives has taken from us. The courage to be ourselves and to seek our own unique destiny.

Do you have this courage? To be yourself, rather than a cog in someone elses machine? To refuse to submit to the violence that surrounds and overwhelms us on a daily basis?

If you are inclined to ponder these questions, you might also consider making moral choices that work systematically to end the violence in our world: consider participating in The Flame Tree Project to Save Life on Earth, signing the online pledge of The Peoples Charter to Create a Nonviolent World and/or helping to develop and implement an effective strategy to resist one or the other of the many threats to our survival using the strategic framework explained in Nonviolent Campaign Strategy.

Of course, these choices arent for everyone. As Gandhi observed: Cowards can never be moral.

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Do You (And Jon Snow) Suffer From Genealogical Bewilderment? – Above the Law

Friday, September 1st, 2017

Egg donors and sperm donors are the angels sent from above. Theyre the answer to prayers for a baby for many people trying to grow their family. Singles, gay couples, and straight couples suffering from infertility alike all turn to the generosity of gamete donors. But when it comes to whether a donor should enjoy anonymity or not, the debate continues to rage on.

International Bewilderment. South Africa is the latest country to take the issue seriously. The South African Law Reform Commission released a discussion paper open for public comment through the end of this month. It concerns the question of whether the law should entitle donor-conceived children the right to know their biological roots.

Right to Know Ones Biological Identity. If South Africa opted to take this path, it would not be the first country to ban anonymity for sperm and egg donors. Australia, Britain, and Sweden all give donor-conceived children the legal right to know the identity of their genetic parents. The South African discussion paper argues that children unable to know their genetic identity may suffer from genealogical bewilderment. (The paper doesnt mention Jon Snow by name, but I assume that is who the researchers have in mind.) The argument continues that some children need to know their genetic identity for normal psychological development. (Hmm, isnt Bran the creepy one these days?)

Pro for Anonymity. Its easy to say that a donor-conceived person should be able to know their identity. Who would object to that? But its not so simple. Fertility doctors object, for instance. And people trying to conceive using a donor. And, of course, donors themselves. The spokesperson for South Africas Infertility Awareness Association, Meggan Zunkel, reported that most donors do not want to be contacted by their donor-conceived offspring, and that many people considering turning to an egg or sperm donor would not do so without the promise of donor anonymity.

Dr. Paul Le Roux, the spokesman for the African Society for Reproductive Medicine and Gynecological Endoscopy, elaborated that non-disclosure can be essential for some parents as they need to keep the gamete donation private for specific reasons. This can be important in cultures where gamete donation is less accepted, or where gamete donation is not accepted for religious reasons for example the Muslim Community in South Africa. Le Roux further noted that: Studies on children who have not been informed of their biological parents show that their development has not been harmed and that they are also doing psychologically well.

Is This Debate Moot? Many argue that there is no true choice to remain anonymous. Anonymity, in other words, is dead.Wendy Kramer, the founder of the Donor Sibling Registry (www.donorsiblingregistry.com) a website that connects donor-conceived children with their half-siblings points to a quote from Dr. JLH Ever, Editor-in-Chief of Human Reproduction: All parties concerned must be aware that, in 2016, donor anonymity has ceased to exist.

Kramer explains, if you are planning on being an anonymous donor, it is important to understand that because of commercial DNA testing and Internet search engines, the likelihood of your remaining anonymous in the future is not likely. Kramer feels strongly that egg and sperm banks need to stop promoting the false idea of anonymity to their donors. She notes that just this morning there was a post to the Donor Sibling Registry Facebook page, Exciting news. We are only a few weeks into the DNA journey but I think I have identified my childs donor. Kramer notes that this type of message is very common. Anonymous donors can be found.

Its just that easy. Its time to put the debate to bed and focus on educating donors of the reality of anonymity. Now if only Jon Snow had access to a 23andMe kit. He could have saved us 7 seasons of wondering.

Ellen Trachman is the Managing Attorney of Trachman Law Center, LLC, a Denver-based law firm specializing in assisted reproductive technology law, adoption, and estate planning, and Co-Director of Colorado Surrogacy, LLC, a surrogacy matching and support agency. You can reach her at babies@abovethelaw.com.

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Pot Valet Discusses the Threat of Trademarked Cannabis Strains – PR Newswire (press release)

Friday, September 1st, 2017

SANTA MONICA, Calif., Aug. 31, 2017 /PRNewswire/ --Pot Valet is a leading provider of premium-grade cannabis in California. With its medical marijuana delivery service growing to every city in the state, and soon the whole country, the company offers patients safe, legal, and discreet access to their medicine, eliminating their need to visit a cannabis dispensary.According to Pot Valet, intellectual property rights for cannabis strains are a growing, yet dangerous trend.

Companies are creating their own marijuana strains and protecting them with trademark laws. Profits are taking priority over the rights of patients to access genetically pure medication. A trademark is a visual cue, such as a symbol, phrase, or word that businesses use to identify and distinguish their products from those of their competitors. While this may be a branding advantage, it has consequences.

The purpose of patenting strains and trademarking them is to create an association in consumer's minds between brands and products. It gives the owner exclusionary rights to it, which means that he or she can prevent others from using it, or have confusingly similar marks of their own. Establishing whether a mark infringes on another, hinges on the likelihood of confusing consumers over the product's source.

A trademark environment in the cannabis industry can endanger the genetic purity of the marijuana plant. Companies are spending vast sums of money creating strains nobody will ever hear about in an already strain-flooded market. If the goal of strain breeding is to trademark varieties for future profits, there is a real risk of monopolies forming that can undermine the quality of genetically pure strains.

Creating strains willy-nilly will create chaos in the marijuana industry. Not only will finding the correct strains become an overwhelming task for medical patients, but many 'breeders' will also not comply with proper breeding and registration practices. Creating quality strains requires a database of information about parents, chemical levels, and other crucial characteristics of every strain created.

Overwhelming the market with unregistered strains will diminish the value of this knowledge. Unknown hybrid varieties can confuse entire lineages, reduce their quality, and lead to cross-pollination issues. Pot Valet stands by original household-name cannabis strains. Lab-tested and verified by SC Labs for medical quality, all of its products have a platinum-grade, genetically pure guarantee.

Pot Valet is an online cannabis dispensary based in Santa Monica serving patients across California. Its large selection of products consistently meet regulatory requirements for the highest quality medical marijuana and the company only delivers to valid medical patients.

Patients across California can now get their orders in less than 45 minutes. Those still using the company's Overnight Delivery Service get their medicine the next day. Pot Valet is expanding its Immediate Delivery Service throughout the United States and soon, patients everywhere will enjoy the same benefits.

To order marijuana delivery through Pot Valet, patients must upload a copy of their Medical Marijuana Recommendation and a government I.D. photograph. The company is fully compliant with state laws and regulations.

DISCLAIMER: The content of this press release is the opinion of Pot Valet, written from the company's perspective.

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California law supports surrogacy for gay and straight couples with fertility issues – North Bay Business Journal

Tuesday, August 29th, 2017

California is one of the most receptive states in the country for folks who want to enter surrogacy agreements, according to Wright, who practices law in Marin County. Court support through case law for surrogacy in California goes back some 20 years, she said.

In California, a pre-birth court order can grant parental rights in-utero, whether or not the intended parents have any biological connection to the embryo. When the birth certificate comes out, theres no mention of surrogacy, Kimborough said.

Many surrogate mothers report that the most rewarding part of the process is handing over the baby to new parents, who often view the surrogate as angelic. Anyone who knows me knows Im not an angel, Kimborough said, laughing. Surrogates feel that they gain. Its not that we give so much.

Emotional business

The business has powerful emotional underpinnings. There is an altruism that is unparalleled, Wright said.

Intended parents usually come into the process from a place of loss, Wright said. Unfortunately, my husband and I struggled with fertility issues over nearly seven years, she said. She had both miscarriage and late-term pregnancy loss. Through in vitro fertilization with her egg and her husbands sperm, they were able to eventually have a son, now age 6. Along the way, they considered both adoption and surrogacy. Infertility is statistically about a third of the time tracked to the woman, a third to the man and a third inexplicable.

Its a difficult, traumatic thing, Wright said of fertility issues. You hope and then you lose, hope and then you lose internal battles. Surrogates come from the other side. Pregnancy has been easy, fun, family-building. They come together this incredible meeting.

Adoption and surrogacy rarely cross paths, Kimborough said. We dont compete with adoption agencies. Most intended parents choose one route or the other. It has to do with who you are as a person. Adoption contains more unknowns, with no biological connection or history on the mother or pregnancy. Adoption through foster care can be invasive, she said.

Some women in heterosexual couples who cannot have children on their own struggle with allowing another woman to be a surrogate.

Can I watch somebody else carry my child, have another woman in my life who can do something I cant do, Kimborough said, and give my husband something I could not give very emotional parts of being a woman insecurity or hurt thats so deep she cant get past it.

State laws vary on surrogacy

The American Society for Reproductive Medicine issued guidelines for gestational carriers in surrogacy, Kimborough said.

In many states, those receiving a child must go through an adoption process after the child is born, Wright said.

California Assembly Bill 1217, which became law in 2013, amended the Family Code to require a surrogate mother and intended parents to be represented by independent counsel before entering an assisted-reproduction agreement for gestational carriers. The law required that such an agreement include certain information and be notarized or witnessed. Parties to a surrogacy arrangement cannot undergo an embryo transfer or injectable medication for assisted reproduction until such an agreement has been properly executed.

Traditional surrogacy agreements, where the surrogate is the source of the egg, may be structured as pre-planned adoption agreements. Gestational surrogacy, such as the pregnancy of Gamble, is not allowed in some states but is common in California.

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Dog Bites: A New Book Offers Comprehensive Data and Cross-Disciplinary Analyses – HuffPost

Tuesday, August 29th, 2017

Dog Bites: A Multidisciplinary Perspective is the most comprehensive book ever assembled on all aspects of dog bites. Thirty-two original essays by 39 authors tell it all.

Why dogs bite, the medical, legal, and other consequencesof humans being bitten by dogs, and how to manage them, are"hot" topics globally. (Note 1) I'm very interested in the general topic ofdog biting,but when I go to the web to learn about specific studies there are numerous hits and it's often difficult to make sense of the data and to separate fact from fiction. So, I was thrilled to learn of a new book edited by Daniel Mills and Carri Westgarth calledDog Bites: A Multidisciplinary Perspective. To say this volume is encyclopedic is amajor understatement, and each time I go back to it I learna lot of new information. Its description reads:

Dog Bites is organized into nine sections titled Fundamental Principles, Perceptions of Dogs that Bite, Dog Bites and Risk, Investigative and Legal Issues, Health Issues, Handling the Aggressive Dog, Managing Future Risk, Prevention, and Concluding Comments. Thirty-nine contributors wrote its 32 chapters.

I reached out to Dr. Mills,Europe's first professor of veterinary behavioural medicine,and Dr. Westgarth,a Research Fellow at the University of Liverpool where she completed her Ph.D. in Veterinary Epidemiology and Masters degree in Public Health, and they agreed to answer a few questions about their landmark book. Dr. Mills' answers are in italics and Dr. Westgarth's are in plain text. Our interview went as follows.

Why did you decide to compile the essays for Dog Bites: A Multidisciplinary Perspective?

Dr. Mills: It has been clear that so many people are stakeholders in this and its implications and many people see to use the data for their own agenda by being both selective and over simplifying things. There was however no single authoritative point of reference and so this what we decided to set about addressing.

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Dr. Westgarth: I have always been a very multidisciplinary person, perhaps a jack of all trades, master of none type so to speak, and this extends to my research. But this enabled me to see that different disciplines I was viewing the subject of dog bites from were seeing the problem and the solutions quite differently. For example, dog behaviour counselling (people do stupid things to dogs and simply need to stop) compared to human public health (people do what they do because their environment sets them up to do that and its very difficult to do any different). A broad reference point was needed in order to challenge our personal thinking.

Why is it essential to take a broad and multidisciplinary perspective on the problems at hand?

Its a bit about the three blind men and the elephant- one has the trunk, one the ear and one the leg, they all perceive the animal very differently and so it is with aggressive behaviour we need people to at least appreciate that its complex and that we need to be critical of simple solutions- if they existed it would be solved by now. Only with us coming together can we make real difference.

Even experts in one particular area of dog bites make a lot of assumptions. This was really apparent in reading the manuscript drafts, where authors of one chapter were stating background assumptions to introduce their specialist area whereas another author (who was the specialist in that area) was busting that myth in their chapter. We have to think more broadly and put the pieces of the puzzle together if we are going to effectively prevent and treat dog bites.

Can you briefly summarize some of your findings, noting general trends and surprises?

Oh thats a hard one -- to me, the main thing to appreciate is that we know very little with much confidence generally the data is very poor, but that does not mean that all solutions are equally valid. I think if we can be more critical we can perhaps at least have better pragmatic solutions until the research catches up.

I think people will be surprised at how little we actually know, especially when it comes to risk factors for aggression. Its very easy to read one research paper and think their results are great and must hold true but it is only when you look at a whole body of work and really critically engage with it, which we gave our authors liberty to do (and we did of them), that you start to really see the contrasting findings and gaps. We actually dont know for sure how many dog bites there are, who is at most risk, or how to effectively prevent them. I am also excited by the new data that this book contributes, including breed variations in jaw structure and bite strength, media and societal perceptions of aggressive dogs, and my own data on deep reaching impacts of even minor dog bites on victims.

Who is your intended audience?

Anyone with a serious interest in this, but especially the professions covered by the authorship as well as academics

I hope that there is something for everyone who is interested in dog bites, even if someone is already at the top of the game in their own discipline. For example, dog trainers can learn about statistics, epidemiological risk factors and bacterial infections caused by dog bites. Surgeons can learn about best practice aggressive dog rehabilitation methods and educational initiatives for prevention of bites to children. Vets can learn about societal constructions of aggressive breeds and forensic investigation of human fatalities. It will hopefully open up new worlds for everyone.

Do you have hope that there are solutions to reduce the incredible number reported dog bites and how might this be done? What role can veterinarians play?

It think we can -- but we also need to abandon the idea that all bites are preventable- living with dogs caries an inevitable risk the first question is to educate people about what these risks are and what as a society we think is acceptable- bearing in mind the enormous benefits dog ownership brings. Vets have a role to play (I am a vet) but its relatively small, as they are not well trained in behaviour it needs cross-disciplinary collaboration.

In my mind we definitely have to abandon the blame the victim or owner approach and we cannot rely on education. Education alone does not work in any other health promotion topic, why would it work for dog bites? People often know that they are at risk of being bitten but carry on anyway! We also need to challenge the perceptions that dog bites are just one of those things that cant be prevented. I think many of them can, but there is no one solution, prevention has to happen at a number of levels. The swiss cheese model is one way to think about it: Think of slices of swiss cheese lined up against each other. Each hole is a potential point in the barrier through which failure to prevent the risk could occur. When all these holes align a dog bite occurs. For example, a puppy from a sire with a nervous disposition, the pup went to socialisation classes, but was attacked by another dog a few years later and developed back pain that made him suspicious of being handled, one day a parcel delivery man comes and the dog is usually shut away during these situations but he managed to push on the door and it sprang open and the dog ran to the front of the house, the delivery man reached to stroke him on his back, and was bitten. Hypothetical but you can see where there area number of events and contexts which contributed to this one dog bite event. Each one alone may not have.

Is there anything else you'd like to share with readers?

Not that springs to mind,other than its not a self help book it is a point of reference I actually like your conceptualisation of it as a series of essays in a moreencyclopedicway -- hadnt thought about it like that.

We hope readers find it useful, and to expect some myth-busting and conflicting points of view!

What are some of your current and future projects?

In relation to dog aggression I have on-going work on cultural factors altering perception and how we communicate better interventions, work Im writing up on when the aggressive behaviour becomes seen to be a problem and what that means, and then on-going work on medical issues affecting dogs that show aggressive behaviour.

I have a Ph.D. student investigating in detail perceptions and beliefs regarding risk and safety around dogs, using detailed interviews and field observations, in particular of work places at risk of dog bites. Ive been working closely with Royal Mail on their dog bite prevention initiatives over 7000 postal workers in the UK are bitten each year. We need to better understand how high risk people such as this can be protected from bites. My other research is regarding peoples motivations for walking their dogs, and beneficial effects on human wellbeing. We need to balance the risks and benefits of dogs to society.

Thank you Drs. Mills and Westgarth for compiling this much-needed and timely volume, and thanks to your 39 contributors as well. I find myself picking it up and randomly going to chapters and to the tables and graphs to absorb what you and your authors have written.

All in all,Dog Bites: A Multidisciplinary Perspectiveis extremely comprehensive and a most valuable addition to a scattered and difficult to interpret literature.I hope itreceives a broad global audience, because dog bites know no geographical boundaries. As we learn more and more about why dogs bite, it'll be a win-win for them and for us. And, our companions need all the help they can get (for more on this topic please see "Companion Animals Need Much More Than We Give Them," "Dogs Want and Need Much More Than They Usually Get From Us," and links therein).

Please stay tuned for more information on dogs and other nonhuman companions with whom share our lives. There's no shortage of new studies coming our way.

Note 1: The World health Organization (WHO) reports "There are no global estimates of dog bite incidence, however studies suggest that dog bites account for tens of millions of injuries annually. In the United States of America for example, approximately 4.5 million people are bitten by dogs every year. Of these, nearly 885 000 seek medical care; 30 000 have reconstructive procedures; 318% develop infections and between 10 and 20 fatalities occur. Other high-income countries such as Australia, Canada and France have comparable incidence and fatality rates." According to DogsBite.org, "Each day about 1,000 U.S. citizens require emergency care treatment for serious dog bite injuries. Annually, about 9,500 citizens are hospitalized due to dog bite injuries.1The below statistics and studies examine injury occurrence and the breeds of dogs most likely to inflict severe and fatal injuries. For those new to this area,Quick Statisticsand recentDog Bite Studiesare good starting points. Also see our October report that reviewslevel 1 trauma center studies from 2009 to 2016. More graphics can be seen here.

Marc Bekoffs latest books areJaspers Story: Saving Moon Bears(with Jill Robinson);IgnoringNatureNo More: The Case for Compassionate Conservation;Why Dogs Hump and Bees Get Depressed: The Fascinating Science of AnimalIntelligence, Emotions,Friendship, and Conservation;Rewilding Our Hearts: Building Pathways of Compassion and Coexistence;The Jane Effect: Celebrating Jane Goodall(edited with Dale Peterson);andThe Animals Agenda: Freedom, Compassion, and Coexistence in the Human Age(with Jessica Pierce).Canine Confidential: Why Dogs Do What They Dowill be published in early 2018. Learn more atmarcbekoff.com.

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Dog Bites: A New Book Offers Comprehensive Data and Cross-Disciplinary Analyses - HuffPost

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Tuesday, August 29th, 2017

Theres a lot to be said for being in the right place at the right time, but could Air Supplys long-time success be the result or a chance meeting or was the cosmos working overtime on a little something called destiny? Maybe, but one thing is for surenone of it would have been possible at all without their hard work and tenacity to make it happen.The two Russells, Graham Russell and Russell Hitchcock, happened to be cast in the same Sydney, Australian production of Jesus Christ Superstar in 1975, and everything changed after that.

Many an audience member has probably asked himself if a fine looking group of ladies about to take the stage could possibly do justice to one of the most popular rock bands in the world. Its a legitimate question considering its not easy music to play, so a person cant help but wonder if the music will be taken as seriously as the people in the audience do. However, once the guitars are plugged in and the girls dig into those first few chords, the obvious answer to that question is, oh, hell, yes.

Many a cook tries their hand at duplicating foods they love in restaurants and specialty shops, telling themselves, it cant be that difficult. Often times, theyre right. It can be doneand its pretty simple. However, sometimes, its not as easy as it looks.Mexican food for example looks easy because ingredients are simple, sauces are often slow-cooked and meat is marinated, making this comfort food one of Americas favorite. Recipes are often handed down and each time theyre prepared, a spice might be tweaked or flavor added, depending on taste and preference.

Its been 40 years since Elvis Presley died (August 16, 1977) and millions of people still have the date circled in red on their calendars. People still remember and they still mourn. Some internet sites have gone to the extent of estimating what he would look like now, if he were still here in the physical.This time of year Memphis fills up with more people than usual as crowds in large numbers make their pilgrimages to Graceland for visits to his home while tribute shows pop up all around the country to remember the huge icon that he was.

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CRISPR, Patents, and Nobel Prizes – lareviewofbooks

Tuesday, August 29th, 2017

AUGUST 23, 2017

A CRACK IN CREATION is not The Double Helix. They are both stories of revolutionary biological advances, told by one of the discoverers, but The Double Helix feels like a novel. And, like a historical novel, it was eventually understood to be based on real events but not always reliable history.

A Crack in Creation is also not a history that is, a detailed and precise explanation of who did what and when to produce CRISPR/Cas9, this centurys biggest biological discovery to date. That history awaits its Horace Freeland Judson, whose magisterial The Eighth Day of Creation provided a gripping blow-by-blow account of the birth and adolescence of molecular biology, or its Robert Cook-Deegan, whose The Gene Wars illuminated the beginnings of the Human Genome Project.

Nor is this a how to book for aspiring do-it-yourself CRISPR users; or a deep analysis of the ethical, legal, and social issues CRISPR and its progeny will raise; or a legal analysis of the already (in)famous CRISPR patent fight; or a look at the unresolved Nobel Prize race. And it is not a gossipy inside look at the people intimately involved in CRISPRs invention.

So what is A Crack in Creation? It is an essential start to educating the public.

Humans use of the bacterial defense mechanism called clustered regularly interspaced short palindromic repeats (CRISPR), with or without CRISPR associated protein 9 (Cas 9) along with the technologies that eventually will modify or displace it is of vast importance. Thats not because it is the first way we have found to edit DNA. It misses that distinction by over 40 years. But it is the first truly fast, cheap, easy, and accurate way to do so. It is biotechnologys Model T. The Model T was not, by several decades, the first automobile, but it transformed cars from expensive, unreliable, inconvenient, and rare objects to something everyone could, and soon did, own. It is the change in degree, not in kind, that has transformed the world we live in (nowhere more than California). Similarly, humans have been manipulating living organisms, including ourselves, at least since the dawn of modern man, but CRISPR is the change in degree that turns gene editing from expensive, unreliable, inconvenient, and rare to ubiquitous. It vastly increases our powers to edit all life, including our own.

A Crack in Creation tells the story of CRISPR through the eyes and in the voice of Jennifer Doudna, the UC Berkeley biochemist who was a central figure in harnessing it. (The co-author, Samuel Sternberg, is Doudnas former graduate student.) It divides elegantly into two four-chapter parts, plus prologue and epilogue. The first part describes what CRISPR is and how it was discovered; and the second sets out CRISPRs possible uses in the environment and medicine, and in editing humankind.

It is not, however, the first publication to recount the origins of CRISPR. Indeed, as with the double helix, the identity of the originators is contested. In January 2016, Eric Lander, director of the Cambridge, Massachusettsbased Broad Institute (jointly owned by Harvard and MIT), published a 7,200-word essay titled The Heroes of CRISPR in Cell, one of three leading journals for bioscience publications. It was widely criticized for minimizing the contributions of Doudna and one of her key collaborators, Emmanuelle Charpentier, and highlighting instead the work of Feng Zhang, a researcher at the Broad (and hence Landers employee). As well as triggering, fairly or not, debate over the issue of sexism in science, Landers piece was particularly controversial in that the publication never mentioned its authors conflicts of interest, not just in promoting Zhang as CRISPRs hero, but because of the very expensive patent fight over CRISPR between the Broad Institute and Doudnas employer, the University of California (UC).

This said, what both Lander and Doudna do well is reveal the complex, interlocking, and thoroughly international nature of todays bioscience. They acknowledge the work of a dizzying number of contributors to CRISPR. The first publication to show that CRISPR could be used to edit bacterial DNA was Doudna and Charpentiers Science article in June 2012 but, by that time, scores of researchers had already been exploring what was regarded as a tantalizing bacterial curiosity.

In his Cell article, Lander writes that [t]he story starts in the Mediterranean port of Santa Pola, on Spains Costa Brava, with Francisco Mojica who published a report in 2005 on the existence of, and possible immune system function of, certain odd, largely palindromic, DNA repeats in several bacterial species. Researchers at a yogurt company, Danisco, also played important roles, as did Sylvain Moineau in Quebec and John van der Oost from the Netherlands. Even before her first meeting with Doudna in March 2011, Charpentier and her lab at the University of Ume in Sweden had also contributed to the development of the CRISPR system.

Virginijus iknys, a Lithuanian researcher, greatly improved researchers understanding of the proteins bacteria used with CRISPR. He saw some of the possibilities of CRISPR as a tool and submitted a paper to Cell on the topic on April 6, 2012. Cell rejected his paper, which was eventually published on September 4, 2012, in the Proceedings of the National Academy of Sciences. In the meantime, Doudna and Charpentiers paper was submitted to Science on June 8 and published 20 days later.

But if this is more or less the beginning of the CRISPR discovery story, it is certainly not the end.

Feng Zhang, a brilliant young researcher at the Broad, had spent much of 2011 and 2012 working on a way to use CRISPR in mammalian cells. Zhang submitted his first CRISPR publication on October 5, 2012. Later that month, George Church, an exceptionally wide-ranging and creative Harvard researcher, submitted a paper on using CRISPR in human cells, which Science published in the same issue as Zhangs on January 3, 2013.

This summary does not come close to mentioning all the laboratories involved in discovering and developing CRISPR and does not even begin to talk about the vital contributions of the post-docs and graduate students in those labs, all of them highlighted in A Crack in Creation.

Whose version is closest to the true history of CRISPR? Landers history was widely attacked and A Crack in Creation has already been criticized in a review in Nature for downplaying Zhangs role (though it mentions him more than Lander mentioned Doudna). I suspect neither Lander nor Doudna and Sternberg could tell the full story for at least one sad reason lawyers probably wouldnt let them. Their employers are locked in a patent struggle. The details of who did, said, or knew what when could be crucial to its outcome. How many changes in the manuscripts came as a result of lawyers comments? Probably more than a few.

In fairness, A Crack in Creation never promises to be the definitive history of CRISPR much less a story of all its heroes. It tells Doudnas CRISPR story, as well as the authors thoughts on its potential uses and implications. These uses and implications make up the books second part, The Task. It begins with the use of CRISPR in the non-human world for agricultural purposes and beyond, including the ongoing development of gene drives, an important adaptation of CRISPR that can speed the spread of desired genetic changes in sexually reproducing species, as well as plausible speculation about future unicorns (in this case, the mythical animal). It then addresses the medical applications of CRISPR to living people in the form of so-called somatic gene editing, intended to heal their bodies without changing their eggs or sperm and so not affecting future generations. The authors rightly view this as the least controversial use of CRISPR. The last chapters address what has become the stickiest question for most people: the use of CRISPR to make changes in the genome of the human germline (eggs and sperm) that can be inherited from generation to generation.

Doudnas interest in these last issues is neither new nor shallow. In October 2014, I was invited to a small meeting she was organizing in Napa Valley the following January to discuss the ethical issues of CRISPR. (Coincidentally, this was almost exactly 40 years after the famous 1975 Asilomar meeting to assess safety issues of the first gene editing, recombinant DNA.) The Napa meeting involved about a dozen prominent scientists including Paul Berg and David Baltimore, the two Nobel Prize winners who helped organize the Asilomar meeting and two law professors who work in the field, Alta Charo from the University of Wisconsin and myself. Doudnas genuine concern was evident, not just in calling the meeting but in her active and thoughtful participation in it. And human germline genome editing was clearly the focus of that concern.

The Napa meeting reached consensus surprisingly quickly: the somatic cell uses of CRISPR should be pursued actively, but human germline modifications needed more thought. Doudna took the lead in drafting a commentary, signed by the meetings participants and several others, which Science published in March 2015.

The commentary made four recommendations about human germline editing:

The Science article was not alone. Nature had published a commentary on human gene editing the week before, endorsing somatic cell uses of genome editing, but rejecting germline changes. And two weeks later, an obscure journal published an article in which Chinese scientists reported their (slightly) successful efforts using CRISPR to edit human embryos.

The Chinese group had carefully used human embryos that were not viable and thus could never become babies, but the article still set off a firestorm. One of its results was a US National Academies of Sciences, Engineering, and Medicine initiative to study genome editing. A major part of that initiative was an International Summit on Human Gene Editing held in Washington, DC in December 2015, with additional sponsorship from the Chinese Academy of Sciences and the UK Royal Society. At its end, the summits planning committee (not the sponsoring academies) issued its conclusions, roughly echoing the March Science commentary.

As A Crack in Creation usefully points out, the debate over germline modification is not new. The issue was discussed in print at least 30 years before CRISPR was imagined. But a sense of urgency and some specificity about both the likely intervention and the societies into which it will be launched helps focus discussions. Since the International Summit (and submission of the last manuscript of the book), the National Academies alone have published at least three relevant reports two concerning non-human uses of CRISPR in October 2016 and March 2017, and the third, issued in February 2017 on Valentines Day, on CRISPR and humans, endorsing somatic cell uses of CRISPR and opening the door for possible germline editing for medical reasons.

A Crack in Creation hints that the discussions thus far have modified Doudnas views. Like the February 2017 report, the book shows some openness to human germline modification, at least for addressing clearly genetic diseases.

Personally, I think we focus too much on human germline genome modification. There is no human germline genome there are over seven billion of them, each changing slightly by mutation in every generation. Editing out rare, disease-causing DNA variations or replacing them with the more common safe variants hardly seems radical. The real concerns for germline or somatic human gene editing should be about enhancements (as opposed to disease), but that is just one part of a much wider conversation about all kinds of biological, electronic, and mechanical enhancements. The combination of our great concern about the safety of babies and our ignorance regarding enhancing genetic variants, however, means we have time to get this right. But were way behind in regulating the use of CRISPR in non-humans. The medical, practical, and political constraints around human babies do not exist for mosquito babies, let alone genetically modified microbes or plants. For the moment, we need to concentrate on this much less constrained use of CRISPR, which is already beginning.

Doudna called for discussions about the uses of CRISPR in Napa in January 2015 and A Crack in Creation amplifies that plea, providing the interested public with the background critical to such discussions. But CRISPR has raised two other interesting questions, which, though not discussed in the book, are worth mentioning: the Nobel Prize and the patent fight.

A Crack in Creation says nothing about the likely Nobel Prize for CRISPR, but CRISPR junkies regularly discuss it. A Nobel Prize in either Chemistry or in Medicine and Physiology seems almost certain, and will likely be granted soon. But who will receive it?

Scores of people in many countries contributed to its discovery, but Nobel Prizes in the sciences are limited to not more than three people. Doudna and Charpentier should be shoo-ins, for their own insights, for the work of their labs, and for their first publication. Plausible other candidates include at least Mojica, iknys, Zhang, and Church but four into one wont go.

Many have read Landers Cell article as an effort to tilt the third spot toward his faculty member, Zhang, but the fight over the patent rights for CRISPR could also influence who wins the prize. A Crack in Creation mentions the patent fight only once, as a disheartening twist to what had begun as collegial interactions and genuine shared excitement about the implications of the research. But the patent cases over CRISPR have been unusual, and unusually fascinating, from the beginning. (For more details see various pieces by Jacob Sherkow, the law professor who has followed this most closely.)

In December 2012, Zhang and others (meaning the Broad Institute on behalf of Zhang and others) filed a patent application on the use of CRISPR in any cells from complex organisms, called eukaryotic cells, which include everything from algae to us, as opposed to prokaryotic cells (bacteria and archaebacteria) and viruses. Doudna and Charpentiers patent application had been filed seven months earlier, claiming the use of CRISPR in all cells. But the Broad paid for and got a special expedited patent procedure so that its patent application, though filed after the UCs, was granted in April 2014, before the UCs was decided.

A year later, in April 2015, the UC invoked an interference proceeding, asking the Patent and Trademark Office (PTO) to resolve an apparent inconsistency in patent applications and determine who was the first inventor. In February 2017, the PTO ruled in favor of Zhang and the Broad. But the UC has appealed this decision, and even if it stands, it is possible that the Doudna and Charpentier patent and the Zhang patent will be held valid, in which case someone who wanted to use CRISPR in eukaryotic cells, including human cells, would need licenses from both UC and the Broad.

Furthermore, all patents are limited to the jurisdiction that granted them. US patents have no force outside the United States. This past March, the European Patent Organization granted CRISPR patents to UC, as have the patent authorities in China and the United Kingdom. So we could have a world where the Broad seems to control important US uses and the UC the European, British, and Chinese uses. The rest of the world is, at this point, up for grabs.

What does all this mean? In terms of the ultimate ownership of the most basic CRISPR patent rights, stay tuned. It is too soon to tell. But, in a larger sense, I dont think it matters.

This is mainly a fight about money: about which American universities will make money, and how much of it, off some uses of CRISPR. If the money goes to the UC system, as a Californian I would be pleased. But the question of who profits shouldnt change the adoption of CRISPR. That is, as long as either entity uses a good licensing strategy. Of course, even that may not matter. The CRISPR patents will give the players ownership of some approaches, but they will be of little value if novel approaches are developed. Already various inventors have come up with alternatives to Cas9 as part of the CRISPR complex. Bacteria invented CRISPR billions of years ago and have had time, and selective pressure, to invent variations on it. The harder the Broad or UC try to enforce rigorous patent terms, the more they encourage researchers to invent around their patents. The more they tighten their grip, the sooner the money will slip through their hands.

This raises the more fundamental question of why the CRISPR patent fight is happening at all. Like many people, I initially thought the UC and the Broad would settle their patent dispute quickly. Each would take a certain percent of the royalties for their combined patents and be happy not least because they would avoid tens of millions of dollars of expense, months of distraction for their researchers, and years of uncertainty. If one of the institutions involved were a novice in technology licensing, then it might get greedy and seek a complete victory, but neither the UC system nor the Broad (and certainly not the Broads owners, Harvard and MIT) are novices. They have some of the most experienced and sophisticated technology licensing offices in the world.

So why are they spending so much money on this fight? It might, in part, relate to the Nobel Prize. If Lander really wants to bolster Feng Zhangs case for winning a CRISPR Nobel Prize, then he may think that having Feng win some or all of the patents will be helpful. That seems a bit far-fetched, and yet it could be one factor in the Broads litigation strategy. If so, it is not clear whether it will succeed, even if the Broad patents eventually sweep the field. The Nobel Prize decision-makers need not follow the patent office of any country.

In the end, the history, the prizes, and the patents dont really matter. The structure of DNA would have been discovered without Watson and Crick, and CRISPR did not require Doudna and Charpentier (or Zhang). The discoveries, not those who make them, are important and those discoveries are only important as they affect people. CRISPR heralds a new era of massively increased human control over life, one that will affect every person on Earth, directly or indirectly, and much of the rest of our planets biosphere. If humans are to have any chance of harnessing its benefits, avoiding its risks, and using it in ways consistent with our values and cultures, then we all not just the scientists, ethicists, and patent lawyers need to understand something about CRISPR and its implications. A Crack in Creation is a great place to start.

In the interest of full disclosure, the author has met, been on panels with, and likes Doudna, Charpentier, Zhang, Church, and many of the other scientists discussed in the review. He also has lectured the last three summers in a CRISPR program held by the Innovative Genomics Institute at UC Berkeley for modest honoraria.

Henry T. Greely is a professor of Law, and professor by courtesy of Genetics, at Stanford University, where he directs its Center for Law and the Biosciences and Program in Neuroscience and Society. He is an expert on the ethical, legal, and social implications of advances in the biosciences.

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Ventilin inhaler – Ventolin salbutamol syrup dosage for adults – The Santa Clara

Monday, August 21st, 2017

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Fearing stigmatization, patient’s father seeks retraction of paper on rare genetic mutation – Retraction Watch (blog)

Wednesday, August 9th, 2017

The father of a boy with a rare genetic mutation has accused a scientist of exploiting his child by proclaiming the defect a genetic syndrome and naming it after herself.

At an impasse with scientists investigating, publicizing, and interpreting his sons condition, the father seems willing to use any leverage he can muster to remove the syndrome entry in an online genetic disease database. Based solely on an email he obtained from the database director, the father became convinced that if the paper underpinning the entry were retracted, the syndrome would go down with it. So earlier this year, he withdrew his consent and asked the journal that published the paper for a retraction, based on improper patient consent. He has also threatened to lob accusations of research misconduct at the papers last author.

Marc Pieterse, of The Netherlands, is the father of Vincent, a teenager who has a mutation in the RPS23 gene that has only been found in one other person, so far. In March, an international team of researchers published a paper on Vincents RPS23 mutation in the American Journal of Human Genetics (AJHG), linking it to defective ribosomes, organelles involved in protein synthesis.

One of the scientists Pieterse engaged several years ago is Alyson MacInnes, a rare disease researcher at the University of Amsterdams Academic Medical Center. She is last author of the AJHG paper and the person whose name is now connected to an entry in the Online Mendelian Inheritance in Man (OMIM) database. MacInnes told Retraction Watch that, contrary to what Pieterse claims, she played no direct role in naming the syndrome; OMIM confirmed this account.

The OMIM entry for MacInnes Syndrome, which links the RPS23 mutation with a collection of features that resemble Vincents hearing loss, issues with the hands was created on March 29, weeks after the paper was published. Pieterse said he was shocked when he found it in April as he was browsing the database.

Pieterse told us he feels used and fears that the designation will stigmatize his sons mutation. A syndrome is a disease, he said. Now, he wants the database entry either changed he prefers the umbrella term ribosomopathy, which is used in the paper or taken down.

Believing MacInnes submitted Vincents condition for consideration, Pieterse demanded she find a way to remove it. When she didnt respond, he went directly to AJHG and OMIM to get the paper and syndrome entry removed.

So far, nothing has worked.

A campaign begins

The Pieterses found out about Vincents mutation after a long diagnostic odyssey that ultimately resorted to sequencing all the protein-coding regions of Vincents genome. In 2015, the Journal of the American Medical Association published a news feature on Vincents diagnosis, saying it heralded a new era of clinical genomics.

Marc is a former telecommunications engineer and entrepreneur who has shifted his focus to raising his four children. He told Retraction Watch that although hes not a scientist, in the years since receiving Vincents diagnosis he has committed himself to advocating for further study of the mutation and has even co-authored a paper on RPS23. Marc claims he played a role in connecting MacInnes, Baserga, and several other European scientists, who eventually published the AJHG paper together.

When Pieterse found the OMIM entry for MacInnes syndrome, he believed that MacInnes had created it to boost her career. He told us that after he found it, he tried asking her to take it down. However, their relationship had at that point already suffered a communication breakdown and he didnt hear back. This further upset him and he began a campaign to bring down the entry by any means possible.

But MacInnes told us she had nothing to do with either the OMIM entrys creation or its naming:

I did not submit this paper to OMIM or in any way initiate this entry as a syndrome. This was independently picked up by OMIM and registered as such; apparently such registrations are made upon their decision only.

OMIM director Ada Hamosh confirmed this to Retraction Watch:

Dr. Macinnes did not ask for this to be named after herself and did not bring it to our attention.

We are dealing with this gene-phenotype relationship exactly as we would any other. We did this because this is what we do.

Hamosh, a geneticist at Johns Hopkins University, told us that the term syndrome is for a constellation of features and that the naming was done in accordance with policies that have long been in place at OMIM:

Sometimes something has too many features to be described succinctly. In that case, the default way to name something is to use the first authors last name and last authors last name.

Indeed, Hamosh told us that at first the syndrome was called Paolini-MacInnes syndrome, after first author Nahuel Paolini, of the University of Amsterdam. However, Hamosh said OMIM later realized there were four co-first authors. OMIM never adds more than three names to a syndrome, so Hamosh simply named it after MacInnes:

Given how little we know about it, it makes more sense to name it eponymously than after some features I cant put my hands on, especially since we have a policy on not ever naming something after a gene.

Its stigmatizing

Part of Pieterses issue with dubbing the condition a new syndrome is the early and ongoing nature of RPS23 research, and he isnt alone. In an email to Hamosh, MacInnes co-author Susan Baserga, a professor at the Yale School of Medicine, said:

I was very surprised that you are so pressed to name the phenotype as a new syndrome, especially since the clinical findings are so non-specific. I find this very odd indeed, and worry that it muddles the medical and genetic literature instead of providing clarity. This is so new that I am not even sure that it is a syndrome, and worry that it is presumptuous at best and wrong at worst.

Baserga, who did not respond to our requests for comment, also suggested that OMIM simply call the condition a ribosomopathy, as the AJHG paper does. But Hamosh told Retraction Watch:

We never, ever, ever, name a disease after a gene.

Gene symbols are not stable. More fundamentally, many, many, many genes have more than one condition associated with them. It is not a good idea to put a gene name into a disease name. Thats why we wont call it RPS23 ribosomopathy. Its not personal, we wont do this for any gene.

Pieterse told us that neither Hamosh, nor anybody else from OMIM, has ever informed him that OMIM itself created the entry and that MacInnes Syndrome is the result of standard naming procedures.

Like MacInnes, Hamosh wont respond to his attempt at contact. But Pieterse has obtained an email chain, from late April, between those two scientists, as well as Baserga. In it, Hamosh wrote:

Are you planning to retract or correct the paper to indicate the apparent uncertainty regarding its conclusions? If so, we will remove the phenotype and reclassify the variants.

Niether MacInnes nor Baserga thought a retraction was necessary, but this exchange convinced Pieterse that a retraction would force OMIM to remove the entry. So he wrote MacInnes to inform her he was withdrawing his parental consent and asked AJHG to retract the paper. Pieterse told Retraction Watch that the consent form he submitted to the University of Freiburgs medical center, in Germany (cells used in the study were created there) was very broad and that he believed it would allow him get the paper pulled.

Readers may recall some of the cases weve covered in which patient consent issues have led to papers being retracted. Pieterses situation most closely resembles a story we covered in 2015, where the authors requested a retraction from the Journal of Medical Case Reports after a legal guardian withdrew permission after publication.

But his attempt to trigger retraction didnt work. AJHG editor David Nelson, of the Baylor College of Medicine, told Pieterse the journal had looked into the situation but found nothing improper. According to an email shared by Pieterse, Nelson wrote:

Because there was no reason to retract the article due to misrepresentation of scientific content, we investigated the issues around withdrawal of patient consent. We have been in communication with the [University of Amsterdam Academic Medical Center] Biobank Committee and Medical Ethics Committee and they have confirmed that withdrawal from the study is not relevant to the article and data that have been published already.

Given the serious implications of a retraction on the journal, the authors of the article, and the scientific record, we have therefore decided that the American Journal of Human Genetics will not retract the article.

In an email to Retraction Watch, Nelson expanded on what he told Pieterse:

Our understanding from the authors and their institutions who obtained and approved consent for this study is that it is possible for research subjects to withdraw their consent at any time and that samples and information should be destroyed upon withdrawal. However, published scientific articles deriving from the studies are not subject to the consent withdrawal and this was confirmed by individuals familiar with European Union Regulations relating to personal data.

Pieterse told us that knows a retraction would be counterproductive to his long-term goal, which is to see the research around Vincents mutation grow. But he still wants to see the OMIM entry come down:

At a certain moment, people are going to cite OMIM in genetics papers and its going to spread. If you want to correct something, you should correct it fast. Once the internet is soaked, you cannot do that.

Like Retraction Watch? Consider making atax-deductible contribution to support our growth. You can also follow uson Twitter, like uson Facebook, add us to yourRSS reader, sign up on ourhomepagefor an email every time theres a new post, or subscribe to ourdaily digest. Clickhere to review our Comments Policy. For a sneak peek at what were working on,click here.

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Modification of genes in human embryos could mark turning point in human evolution – The Globe and Mail

Tuesday, August 8th, 2017

It appears, by all accounts, to be a momentous scientific achievement and possibly a turning point in human evolution. In a study released last week, scientists at Oregon Health and Science University confirmed they were able to modify genes in viable human embryos, proving the potential to permanently alter the makeup of a genetic line.

In this case, that meant replacing and repairing a mutated gene that causes a common and deadly heart disorder. But the possibilities heralded by gene-editing technology are endless, the scenarios as divided as they are bold. In some visions, it leads to a population of designer babies or consumer eugenics. Others imagine a utopia of scientific advancement where humans live free of disease, and devastating conditions are eradicated for the betterment of humanity. What direction the technology will take is the topic of much debate.

The big thing which is making the scientific and ethics community get excited, and on the other hand a little bit hot and bothered, is its a mechanism to change genes for multiple generations, says Dr. Alice Virani, a genetic counsellor and director of ethics at British Columbias Provincial Health Services Authority. There are two ways to look at it, the more realistic ramifications and the sci-fi, if-this-was-out-of-control ramifications.

Opinion: Gene editing is not about designer babies

The team at the Oregon universitys Center for Embryonic Cell and Gene Therapy used technology called CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, to repair or edit the gene carrying the heart disorder, seemingly with greater success than previous attempts by scientists in China.

News of the research has been anxiously anticipated by many in the field, both for what it means for the potential eradication of a disease such as hypertrophic cardiomyopathy and for the fundamental questions it raises about human reproduction, health and society.

When the study was leaked days before its publication in the journal Nature, its lead scientist, Dr. Shoukhrat Mitalipov, attributed the release to likely a combination of hot words: CRISPR, gene-editing, and designer babies.

The study and its combination of hot words didnt disappoint.

The New York Times hailed the milestone in research, while The New York Post cried BABE NEW WORLD and described an amazing and slightly terrifying breakthrough. A headline on Vox declared simply, This Is Huge.

Even actor Ashton Kutcher tweeted enthusiastically about the scientific breakthrough, writing: Scientists successfully used CRISPR to fix a mutation that causes disease. This is why I wanted to be a geneticist!

The tweet ignited among his followers the same range of responses that are always so keenly tied to the issue of changing human genes, from hope that devastating conditions such as muscular dystrophy will be eradicated, to fear about the unknown consequences of playing God.

Dr. Timothy Caulfield, a Canada Research Chair in Health Law and Policy and professor at the University of Alberta, says the polarized and dramatic response he has seen in recent days reminds him of early reaction to stem-cell science, where, he says, It was either going to be cloned armies, or we were going to eradicate all disease.

In fact, neither has turned out to be the case, and so it may be with gene editing as well.

We need to be cautious not to hype the benefits and be cautious not to hype the ethical concerns, he says. There are real issues on both sides of the debate but lets make sure our discourse is evidence-formed.

He described the new research as a genuinely exciting area, and said the potential of CRISPR which is used not only in human genetics, but also has potentially revolutionary applications for agriculture, animals, plants and food has introduced both exciting possibilities and reasons for deep policy reflection.

Erika Kleiderman, a lawyer and academic whose work focuses on gene-editing technologies, stem-cell research and regenerative medicine at the Centre of Genomics and Policy at McGill University, says the Oregon teams research is exciting because it confirms the ability of CRISPR technology to repair genetic mutations, and establishes the basic safety of the technique in a research context. And while she said people often go straight to thinking about the potential for manipulating genes to create so-called designer babies, a concept that is cool but also quite frightening, the medical implications could be equally staggering, and are far more likely.

For example, something like Huntington disease, she says. Being able to prevent that or treat that one day, in my opinion, would be a fantastic leap for our scientific knowledge and medical advancement. That being said, people will raise the eugenics argument. Is that a possibility? Yes. Are we close to that? I dont think so.

Canada has strict laws around genetic modification and editing, and altering genes in a way that could be passed on to future generations is a criminal offence under the Assisted Human Reproduction Act, punishable with fines up to $500,000 or 10 years in prison.

But as the technology takes a large step forward, Ms. Kleiderman and Dr. Caulfield and are among a group of Canadian scientists and academics calling for less regulation around genetic science and research in Canada, not more.

Both were involved in the creation of an editorial published in the journal Regenerative Medicine in January calling for new consideration of the issues and ethics involved in gene editing, and a revision of Canadian legal policy.

A criminal ban is a suboptimal policy tool for science as it is inflexible, stifles public debate, and hinders responsiveness to the evolving nature of science and societal attitudes, the editorial read. It was signed by seven other experts and ethicists, and came out of a think tank on the future of human gene editing in Canada held at McGill last summer.

Dr. Caulfield says legal prohibition of certain genetic research doesnt make sense when we dont yet know or understand where the science is going, or what the benefits or harms could be. Instead, he says he believes in regulation in problematic areas, while allowing for studies and trials. He says that some of the slippery slope scenarios people fear such as using genetic modification for human enhancement and to achieve superficial traits such as height remain distant possibilities given the complexity of the science.

That is not to say there are not risks or issues to be addressed as the technology continues to evolve. Ms. Kleiderman says that includes consideration of the potential risk to future generations, the safety of the technology and other irrevocable, if unintended, consequences, although she says those risks are not unique to gene modification but true of all technologies.

When it comes to CRISPR, one of the areas it would be most beneficial is with the treatment of prevention of disease which I think most people would be in agreement with, she says. Of course, we need to be mindful of doing not-so-positive things with it, like going down the enhancement route.

She said other potential issues, such as the preservation of human diversity and individuality, the welfare of children born from this technology and the potential for creating new forms of inequality, discrimination or societal conflict, all require significant consideration and research.

There is time. Although the technology is moving quickly, there is still a long way before gene editing is used in clinical human trials. Even after that, Dr. Virani says for the foreseeable future the technology will most likely be used by a small group of people in specific scenarios related to the prevention of serious genetic disease.

Im not saying we shouldnt be concerned about those potential issues, but sometimes we make that leap too quickly, she said. We dont necessarily [think] that the most likely scenario is that couples will use this technology on a very limited basis if they know their child may potentially have a devastating genetic condition. Thats not something that suddenly everyone is going to start to do. I think theres sometimes that leap to, Oh, we can create designer babies, but I think were very much in the lessening-burden-of-disease phase rather than the designer-baby phase, though thats where peoples minds go.

Dr. Virani said one of her own concerns is the possibility of off-target effects, where changing a gene unexpectedly alters something else in the genome. Other concerns are more social reality than science fiction, including that the technology and the ability to prevent disease may only be available to those who can pay for it. Eradicating a horrible disease is one thing. Eradicating it only for families who can afford it is another.

So is it going to look like just the wealthy are going to be able to afford this type of technology? she asks. Thats very problematic in my eyes from an ethics point of view, and thinking about fairness in society. If only poor people get Huntington disease, then the lobby to support Huntington disease research is greatly diminished. Its kind of like a two-fold negative effect.

On Thursday, the American Journal of Human Genetics ran a policy statement signed by 11 organizations from around the world, including the Canadian Association of Genetic Counsellors, urging a cautious but pro-active approach as the science moves forward. The statement includes an agreement that gene editing should not yet be performed in embryos carried on to human pregnancy. (The embryos used in the Oregon research were created only for the research, and were not developed further.) It also outlines a number of criteria that should be met before clinical trials take place, and supports public funding for the research. The U.S. government does not allow federal funding for genetic research on embryos. The Oregon research was funded by the university.

We dont want it to go speeding ahead, said Kelly Ormond, the lead author of the policy statement and a genetics professor at Stanford University in California. We want people to be very transparent about whats happening and we want things to undergo good ethics review, and for society to actually be engaged in these dialogues now while this research is just starting to happen.

She said she believes its important to be pro-active in talking and thinking about the issues related to the technology, and starting a broader conversation of how gene editing should and will be used.

We can all agree that that world [of eugenics and designer babies] doesnt feel very comfortable, and I think most of us dont want to go there, she said. So we need to find ways to prevent that from happening.

Follow Jana G. Pruden on Twitter: @jana_pruden

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The Tragedy of Playing Politics with Children’s Health – HuffPost

Saturday, August 5th, 2017

by Johan Bester MBchB, PhD, MPhil and Eric Kodish MD

The case of Charlie Gard, a terminally ill British 11-month-old who passed away Friday, is deeply tragic for all involved: the parents who must try to come to terms with the fact that no curative therapy existed for their child; the physicians and nurses who have dedicated their lives to helping children and must continue to do what they think is best for the patient; and the judges who use phrases such as heaviest of hearts when handing down their judgments.

The tragedy is compounded when such cases become politicized, as has happened with Charlie.

Charlie was born with encephalomyopathic mitochondrial DNA depletion syndrome (MDDS), a rare genetic illness. Charlie suffered respiratory failure, muscle weakness, congenital deafness, encephalopathy, and eventual structural brain damage.

Charlies parents hoped to pursue an experimental treatment in the U.S. nucleoside therapy which has never been tried for Charlies variant of MDDS, but has shown some extension of life expectancy in patients with a different genetic variant of MDDS.

However, doctors at Londons Great Ormond Street Hospital did not believe this to be in Charlies best interest, and sought permission from the British courts to withdraw life-sustaining treatment and move Charlie to palliative care, where the focus would be on ensuring that his last days would be as comfortable as possible.

A lengthy series of court cases followed. At each stage at the High Court, the Supreme Court and to the European Court of Human Rights judges agreed that life sustaining treatment be withdrawn, that a palliative care approach should be followed, and that nucleoside therapy would be inconsistent with Charlies best interest. At this point, Charlie was considered to be terminally ill.

The court judgments explicitly rejected financial considerations as a basis for making the judgment, focusing instead on evidence of benefit versus harm and Charlies best interest.

As news coverage of the case exploded, it did not take long for coverage of the case to take on a political and ideological tone.

President Donald Trump and Pope Francis both offered to intervene to provide continued treatment to Charlie. Not long after, Vice President Mike Pence stated in an interview that Charlies parents were submitted to a government program that says, No, were going to remove life support from your precious 11-month-old child because the government has decided that the prospects of their life are such that they no longer warrant an investment in health services, and the American people ought to reflect on the fact that for all the talk on the left about single-payer, thats where it takes us.

Although the leaders on the left have been largely silent on Charlies case, some voices from the left responded with a rebuttal; some rightly pointed out that the central consideration in Charlies case had always been about Charlies best interests. Others went further, decrying the political vampirism of the right and defending universal healthcare systems.

The effect of all of this is to politicize the case.

Jonathan Haidt, an ethicist and social psychologist, tells us what happens in the psychology of politics: Otherwise reasonable people adopt a team mentality, us-against-them. When confronted with a politicized issue, they instinctively choose as their team would choose, and then come up with rational arguments to defend their choice afterwards.

Reasoned dialogue becomes less possible; people form into groups, aligned with their political tribe, becoming more and more entrenched in their respective ideologies.

Politicizing Charlie means that suddenly his case ceases to be about the suffering of a boy and his parents; it has been co-opted for a political and ideological purposes, complete with a set of villains who are ready to withhold from a child and parents what are rightly theirs.

It uses the emotion around the case to galvanize people towards a specific political goal. It now becomes about us against them. The facts of the case and the suffering caused is now almost incidental to what has become a political phenomenon.

In all of this, a greater tragedy occurs.

The case is used for a purpose that has nothing to do with those whose interests are at stake. Central to this case are grieving parents and healthcare professionals and, most importantly, a sick child. Because this case has now become a political football, their interests are compromised. The parents cannot grieve on their own; their every emotion, decision, and question is broadcast in the media and scrutinized by those who have an agenda.

It is hard for parents to come to terms with the loss of a child. It is even harder when they do it in public, and as the public faces of a political agenda. In the public discourse Charlies best interests take a back seat to the political purpose he serves. He has become an object rather than a person.

Politicizing such tragedies unnecessarily adds pain and angst to an already heartbreaking situation. The healthcare of children should not be a partisan issue, and it should not be politicized. Wherever one is on the political spectrum, what is best for the child should be the central consideration when making healthcare decisions for children.

What can we do to avoid politicizing future cases? First, we call for media restraint. It is difficult to report nuanced ethical and legal issues in medicine in a way that clarifies rather than confuses. If this cannot be done, it should not be done. Sensationalism should be avoided at all costs.

Second, we recommend that courts, hospitals and doctors adopt policies to keep things private that should be private. This is challenging, but should be thought through carefully.

Lastly, this case and others like it underlines the place for clinical ethics consultation in hospitals. In situations like these, clinical ethicists are invaluable at the bedside and on the hospital floor. Wed like to see clinical ethics consultation be part of every hospital.

Charlies case was not the first to be politicized; think of other high-profile cases such as the Sciavo case. In all such cases, tragedy is made worse by politicizing it. Let us hope that Charlies will be the last.

Johan Bester, MBchB, Ph.D., M.Phil., is the director of Bioethics at the UNLV School of Medicine, University of Las Vegas, Nevada. Eric Kodish, M.D., is a professor of Pediatrics and Bioethics at Cleveland Clinics Lerner College of Medicine.

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First human embryo editing experiment in US ‘corrects’ gene for heart condition – Washington Post

Saturday, August 5th, 2017

Scientists have successfully edited the DNA of human embryos to erase a heritable heart condition that isknown for causingsudden death in young competitive athletes, cracking openthe doors toa controversial new era in medicine.

This is the first time gene editing on human embryos has been conducted in theUnited States. Researcherssaid in interviews this weekthat theyconsider their work very basic. The embryos were allowed to grow for only a few days, and there was never any intention to implant them to create a pregnancy. But they also acknowledged that they will continue to move forward with the science, with theultimate goal of being able to correct disease-causing genes in embryos that will develop into babies.

News of the remarkable experiment began to circulate last week, but details became public Wednesday with a paper in the journal Nature.

The experiment is the latest example of how the laboratory tool known as CRISPR (orClustered Regularly Interspaced Short Palindromic Repeats), a type of molecular scissors, is pushing the boundaries of our ability to manipulate life, and it has been receivedwith both excitement and horror.

The most recent work is particularly sensitive because it involves changes to the germ line that is, genes that could be passed on to future generations. The United States forbids the use of federal funds for embryo research, and theFood and Drug Administration is prohibited from considering any clinical trials involving genetic modifications that can be inherited. A report from the National Academies of Sciences, Engineering and Medicine in February urged caution in applying CRISPR to human germ-line editingbut laid out conditions by whichresearch should continue. The new study abides by those recommendations.

This animation depicts the CRISPR-Cas9 method for genome editing a powerful new technology with many applications in biomedical research, including the potential to treat human genetic disease or provide cosmetic enhancements. (Feng Zhang/McGovern Institute for Brain Research/MIT)

Shoukhrat Mitalipov, one of the lead authors of the paper and a researcher at Oregon Health & Science University, said that he is conscious ofthe need for a larger ethical and legal discussion about genetic modification of humans but that his team's work isjustified because it involves correcting genes rather than changing them.

Really we didnt edit anything. Neither did we modify anything, Mitalipov said. Our program is toward correcting mutant genes.

Alta Charo, a bioethicist at the University of Wisconsin at Madison who is co-chair of the National Academies committee that looked at gene editing,said that concerns about the work that have been circulating in recent days are overblown.

What this represents is a fascinating, important and rather impressive incremental step toward learning how to edit embryos safely and precisely, she said. However, no matter what anybody says, this is not the dawn of the era of the designer baby. She said that characteristics that some parents might desire, such as intelligence and athleticism, are influenced by multiple genes and that researchers don't understand all the components of how such characteristics areinherited, much less have the ability to redesign them.

The research involved eggs from 12 healthy female donors and sperm from a male volunteer who carries the MYBPC3 gene, which causes hypertrophic cardiomyopathy. HCM is a disease that causes an abnormal thickening of the heart muscle butcan cause no symptoms and remain undetected until it causes sudden cardiac death. There's no way to prevent or cure it, and it affects1 in 500 people worldwide.

Around the time the sperm was injected into the eggs, researchers snipped out the gene that causes the disease. The result was far more successful than the researchers expected: As the embryo's cells began to divide and multiply, a huge number appearedto be repairing themselves by using the normal, non-mutated copy of the gene from the women'sgenetic material. In all, they saw that about 72 percent were corrected, a very high number. Researchers also noticed that theredidn't seem to be any off-target changes in the DNA, which has been a major safety concern ofgene-editing research.

Mitalipov said he hoped the technique could one day be applied to a wide variety of genetic diseases and that one of the team'snext targets may be the BRCA gene mutation, which is associated with breast cancer.

The first published work involving human embryos, reported in 2015, was done in Chinaand targeted a gene that leads to theblood disorder beta thalassemia. But those embryos were abnormal and nonviable, and there were far fewer than the number used in the U.S. study.

Juan Carlos Izpisua Belmonte, a researcher at the Salk Institute who is also a co-author on the new study, saidthat there are many advantages to treating an embryo rather than a child or an adult. When dealing with an embryo in its earliest stages, only a few cells are involved, while in a more mature human being there aretrillions of cells in the body and potentially millions that must be corrected to eradicate traces of a disease.

Izpisua Belmonte said that even if the technology is perfected, it could deal with only a small subset of human diseases.

Idont want to be negative with our own discoveries, but it is important to inform the public of what this means, he said. In my opinion the percentage of people that would benefit from this at the current way the world is rather small. For the process to make a difference, the child would have to be born through in vitro fertilization or IVF and the parentswould have to know the child has the gene for a disease to get it changed. But the vast majority ofchildren are conceived the natural way, and this correction technology would not work in utero.

For years, some policymakers, historians and scientists have been calling for a voluntary moratorium on the modification of the DNA of human reproductive cells. The most prominent expression of concern came in the form of a 2015 letter signed by CRISPR co-inventor Jennifer Doudna, Nobel Laureate David Baltimore and 16 other prominent scientists. They warned that eliminating a genetic disease could have unintended consequences on human genetics, society and even the environment far into the future.

On Wednesday,Marcy Darnovsky, executive director of the Center for Genetics and Society, warned that the O.H.S.U. research would result in fertility clinics offering genetic upgrades to those able to afford them.

Once those commercial dynamics kick in, we could all too easily find ourselves in a world where some peoples children are considered biologically superior to the rest of us, she said in a statement. We need to ask ourselves whether we want to add that new kind of excuse for extreme social disparities to the ones we already tolerate.

Researchers who worked on the heart-condition experiment appear to have differing views on where their work is headed.

Paula Amato, a reproductiveendocrinologist with O.H.S.U., was excited about the idea of being able to editout diseases before birth. She said that while pre-implantation genetic screening of embryos is now available, it isn't perfect.She talked about how one of her patients went through three cycles of in vitro fertilizationbut all theeggs that were harvested hadthegene mutation that causes diseases.

With gene correction technology, Amatosaid, we could have rescued some of those embryos.

ButIzpisua Belmonte said he is focusing on using thefindings from this study to further research into gene modifications during a pregnancy or after birth into adulthood.

Ifeel that the practical thing to do is deal with the diseases people have, not with the disease they may have, he said.

Mitalipov said he hopes regulators will provide more guidance on what should or should not be allowed.

Otherwise, he said, this technology will be shifted to unregulated areas, which shouldnt be happening.

This story has been updated.

Read more:

A new CRISPR breakthrough could lead to simpler, cheaper disease diagnosis

Scientists debate the ethics of CRISPR

Ethicists urge caution in applying CRISPR to humans

Jennifer Doudna ponders 'what it means to be human' on the frontier of gene editing

More:
First human embryo editing experiment in US 'corrects' gene for heart condition - Washington Post

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Genetics expert discusses creating ground rules for human germline editing – Medical Xpress

Saturday, August 5th, 2017

A Stanford professor of genetics discusses the thinking behind a formal policy statement endorsing the idea that researchers continue editing genes in human germ cells.

A team of genetics experts has issued a policy statement recommending that research on editing human genes in eggs, sperm and early embryos continue, provided the work does not result in a human pregnancy.

Kelly Ormond, MS, professor of genetics at the Stanford School of Medicine, is one of three lead authors of the statement, which provides a framework for regulating the editing of human germ cells. Germ cells, a tiny subset of all the cells in the body, give rise to eggs and sperm. Edits to the genes of germ cells are passed on to offspring.

The statement, published today in the American Journal of Human Genetics, was jointly prepared by the American Society for Human Genetics and four other human genetics organizations, including the National Society of Genetic Counselors, and endorsed by another six, including societies in the United Kingdom, Canada, Australia, Africa and Asia.

Germline gene editing raises a host of technical and ethical questions that, for now, remain largely unanswered. The ASHG policy statement proposes that federal funding for germline genome editing research not be prohibited; that germline editing not be done in any human embryo that would develop inside a woman; and that future clinical germline genome editing in humans not proceed without a compelling medical rationale, evidence supporting clinical use, ethical justification, and a process incorporating input from the public, patients and their families, and other stakeholders.

Ormond recently discussed the issues that prompted the statement's creation with writer Jennie Dusheck.

Q: Why did you think it was important to issue a statement now?

Ormond: Much of the interest arose a couple of years ago when a group of researchers in China did a proof of principle study demonstrating that they could edit the genes of human embryos.

The embryos weren't viable [meaning they could not lead to a baby], but I think that paper worried people. Gene editing in human germ cells is not technically easy, and it's not likely to be a top choice for correcting genetic mutations. Still, it worried us that somebody was starting to do it.

We've been able to alter genes for many years now, but the new techniques, such as CRISPR/Cas9, that have come out in the past five years have made it a lot easier, and things are moving fast. It's now quite realistic to do human germline gene editing, and some people have been calling for a moratorium on such work.

Our organization, the American Society of Human Genetics, decided that it would be important to investigate the ethical issues and put out a statement regarding germline genome editing, and what we thought should happen in the near term moving forward.

As we got into the process, we realized that this had global impact because much of the work was happening outside of the United States. And we realized that if someone, anywhere in the world, were moving forward on germline genome editing, that it was going to influence things more broadly. So we reached out to many other countries and organizations to see if we could get global buy-in to the ideas we were thinking about.

Q: Are there regulations now in place that prevent researchers from editing human embryos that could result in a pregnancy and birth?

Ormond: Regulations vary from country to country, so research that is illegal in one country could be legal in another. That's part of the challenge and why we thought it was so important to have multiple countries involved in this statement.

Also, since 1995 the United States has had regulations against federal funding for research that creates or destroys human embryos. We worry that restricting federal funding on things like germline editing will drive the research underground so there's less regulation and less transparency. We felt it was really important to say that we support federal funding for this kind of research.

Q: Is germline editing in humans useful and valuable?

Ormond: Germline editing doesn't have many immediate uses. A lot of people argue that if you're trying to prevent genetic disease (as opposed to treating it), there are many other ways to do that. We have options like prenatal testing or IVF and pre-implantation genetic testing and then selecting only those embryos that aren't affected. For the vast majority of situations, those are feasible options for parents concerned about a genetic disease.

The number of situations where you couldn't use pre-implantation genetic diagnosis to avoid having an affected child are so few and far between. For example, if a parent was what we call a homozygote for a dominant condition such as BRCA1 or Huntington's disease, or if both members of the couple were affected with the same recessive condition, like cystic fibrosis or sickle cell anemia, it wouldn't be possible to have a biologically related child that didn't carry that gene, not unless germline editing were used.

Q: What makes germline editing controversial?

Ormond: There are families out there who see germline editing as a solution to some genetic conditions. For example, during a National Academy of Sciences meeting in December of 2015, a parent stood up and said, "I have a child who has a genetic condition. Please let this move forward; this is something that could help."

But I also work in disability studies, as it relates to genetic testing, and there are many individuals who feel strongly that genetic testing or changing genes in any way makes a negative statement about them and their worth. So this topic really edges into concerns about eugenics and about what can happen once we have the ability to change our genes.

Germline gene editing impacts not just the individual whose genes are edited, but their future offspring and future generations. We need to listen to all of those voices and try to set a path that takes all of them into account.

That's a huge debate right now. A lot of people say, "Let's not mess around with the germline. Let's only edit genes after a person is born with a medical condition." Treating an existing medical condition is different from changing someone's genes from the start, in the germline, when you don't know what else you're going to influence.

Q: There was a paper recently about gene editing that caused mutations in excessive numbers of nontargeted genes, so called "off-target effects." Did that result surprise you or change anything about what you were thinking?

Ormond: I think part of the problem is that this research is moving very fast. One of our biggest challenges was that you can't do a good ethical assessment of the risks and benefits of a treatment or technology if you don't know what those risks are, and they remain unclear.

We keep learning about potential risks, including off-target mutations and other unintended consequences. Before anyone ever tries to do germline gene editing in humans, it is very important that we do animal studies where the animals are followed through multiple generations, so that we can see what happens in the long term. There's just a lot that we don't know.

There are so many unknowns that we don't even know what guidelines to set. For example, what's an appropriate new mutation level in some of these technologies? What is the risk we're willing to take as we move forward into human studies? And I think those guidelines need to be set as we move forward into clinical trials, both in somatic cells [cells of the body, such as skin cells, neurons, blood cells] and in germline cells.

It's really hard because, of course, we're talking about, for the most part, bad diseases that significantly impact quality of life. So if you're talking about a really serious disease, maybe you're willing to take more risk there, and these new mutations aren't likely to be as bad as the genetic condition you already have. But we don't know, right?

We haven't had any public dialogue about any of this, and that's what we need to have. We need to find a way to educate the public and scientists about all of these issues so people can have informed discussions and really come together as this moves forward, so that were not in that reactive place when it potentially becomes a real choice.

And that goes back to your first question, which is why did we feel like we needed to have a statement now? We wanted to get those conversations going.

Explore further: 11 organizations urge cautious but proactive approach to gene editing

See the original post here:
Genetics expert discusses creating ground rules for human germline editing - Medical Xpress

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Inside researchers’ amazing and terrifying gene editing discovery – NEWS.com.au

Saturday, August 5th, 2017

Chinas eagerness to use genetic enhancement technology has led some to suggest the deeply divisive issue could cause a new kind of Cold War conflict.

WELCOME to the brave new world of gene editing.

An international team of scientists in the United States have safely repaired a gene mutation that causes a heritable heart defect in human embryos sparking debate about the new frontier of genetic engineering.

The first-of-its-kind research, which was spearheaded by the Oregon Health and Science University and published last week in the journal Nature, could one day help families affected by inherited diseases.

I, for one, believe, and this paper supports, the view that ultimately, gene editing of human embryos can be made safe. Then the question truly becomes: If we can do it, should we do it? said Dr. George Daley, the dean of Harvard Medical School.

One major fear is that this kind human embryo modification could give rise to designer babies, allowing parents to pay for desirable traits they want in their kids. I think gene editing can be used to help people who are sick, Marcy Darnovsky, director of the Center for Genetics and Society said.

But the idea of using it on the front end to engineer a future generation we need to draw a bright line there.

She insisted that current embryo-screening technology, done routinely at in-vitro fertilisation clinics across America, already helps parents avoid passing on genetic diseases to their kids.

If youre worried about passing on some inherited disease, you can already do that without mucking around with your childs genes, she said.

David King, of the Human Genetics Alert, a UK-based organisation, said governments need to wake up and pass an immediate global ban on creating cloned or GM [genetically modified] babies before it is too late.

If irresponsible scientists are not stopped, the world may soon be presented with a fait accompli of the first GM baby, he said.

In this photo provided by Oregon Health & Science University, taken through a microscope, human embryos grow in a laboratory for a few days after researchers used gene editing technology to successfully repair a heart disease-causing genetic mutation.Source:AP

But Shoukhrat Mitalipov, an embryologist at OHSU who led the gene-editing experiment, said the research was about correcting genes that cause diseases, not altering them.

Really, we didnt edit anything. Neither did we modify anything, Mitalipov said. Our program is toward correcting mutant genes.

The researchers used a gene-editing tool called CRISPR-Cas9 which acts like a pair of molecular scissors to target a mutation that causes hypertrophic cardiomyopathy, a disease that weakens the heart and has led to the sudden deaths of many apparently healthy young athletes.

They then injected sperm from a donor with the heart disease, which affects 1 in 500 people worldwide, into eggs from 12 healthy patients, along with the genetic scissors to snip out the mutated gene. Scientists were surprised to discover the embryos then repaired themselves, taking a healthy copy of the gene from the egg as its cells began to multiply.

The embryos are really looking for the blueprint, Mitalipov said. Were finding embryos will repair themselves if you have another healthy copy.

All told, the experiment was successful in 42 of the 58 embryos used, about 72 per cent of the time.

Mitalipov now hopes the strategy could one day be used to prevent a slew of heritable diseases caused by gene mutations, which include Huntingtons disease and cystic fibrosis.

Every generation on would carry this repair because weve removed the disease-causing gene variant from that familys lineage, he said. By using this technique, its possible to reduce the burden of this heritable disease on the family and eventually the human population.

There have been previous attempts to edit embryos in China but those experiments were marred by a problem called mosaicism, which means some cells in the embryo still carry the mutation.

Mitalipov said they solved that problem by intervening before fertilisation. Everybody was injecting too late, he said.

But Chinas eagerness to use CRISPR technology has heightened concerns about designer babies and prompted some to suggest the deeply divisive issue of genetic enhancement could cause a new kind of Cold War conflict.

Shoukhrat Mitalipov, left, talks with research assistant Hayley Darby in the Lab. Mr Mitalipov led a research team that, for the first time, used gene editing to repair a disease-causing mutation in human embryos. Picture: Kristyna Wentz-Graff/Oregon Health & Science UniversitySource:AP

Scientists are still a long way off from taking their gene-editing experiments out of the lab and using them on pregnant women. There are safety concerns, of course, but also regulatory roadblocks in the US.

The National Institutes of Health doesnt fund research involving embryos, and Congress doesnt allow the FDA to consider any experiments that involve genetically modified human embryos. This experiment was financed by OHSU, the Institute for Basic Science in South Korea and others.

Particularly controversial is the idea of germ-line editing making precise genetic changes that can pass on to future generations.

Advances in technology have given us an elegant new way of carrying out genome editing, but the strong arguments against engaging in this activity remain, the NIH said in 2015.

These include the serious and unquantifiable safety issues, ethical issues presented by altering the germ line in a way that affects the next generation without their consent and a current lack of compelling medical applications justifying the use of CRISPR-Cas9 in embryos.

But more recently, the National Academies of Sciences, Engineering and Medicine took a softer approach, advising caution but not prohibiting germ-line editing.

We say proceed with all due caution, but we dont prohibit germ line after considerable discussion and debate, said Richard Hynes, an MIT biologist who chaired the review. Were talking only about fixing diseases.

Mitalipov said regulators should start giving more guidance on whats permissible especially since some scientists may resort to conducting their experiments in areas that dont have regulations. This technology will be shifted to unregulated areas, which shouldnt be happening, he told The Washington Post.

Mitalipov added that they could be interested in continuing their work in other countries, like the United Kingdom, NPR reported.

Medical ethicist Arthur Caplan said the technology is still at embryonic stages in terms of developing legal guidelines. Who should own genetic-engineering techniques, and what, if any, requirements will they have to make the taxpayer-funded research that made this possible available and accessible at affordable prices? said Caplan, founder of the Division of Medical Ethics at NYU School of Medicine.

This article originally appeared on The New York Post.

Read the rest here:
Inside researchers' amazing and terrifying gene editing discovery - NEWS.com.au

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