Saturday, August 19, 2017

“We will teach them a historic lesson”

Pro-government assembly in Venezuela takes Congress’ powers


Standoff between President Nicolas Maduro and his political foes escalates
“We will teach them a historic lesson,” constitutional assembly President Delcy Rodriguez said as delegates broke into loud applause while voting by acclamation for the measure.

Obesity: "...government must do more..."

Public Health England says government must do more to tackle childhood obesity



The levy, or sugar tax, will create an additional charge for drinks manufacturers whose products exceed around 5% sugar content.
But the Obesity Health Alliance (OHA), a coalition of more than 40 leading health charities, medical colleges and campaign groups, said that "despite some good progress", its assessment of the plan was: "Must try harder."

Medicaid waivers and negotiated federalism in the US: is there relevance to other federal systems?

 2017 Jan 1:1355819617702175. doi: 10.1177/1355819617702175. [Epub ahead of print]

Medicaid waivers and negotiated federalism in the US: is there relevance to other federal systems?

Author information

1
1 LeRoy Collins Eminent Scholar and Professor of Political Science, Department of Political Science, Florida State University, USA.
2
2 Professor of Political Science and Public Health Program Director, Florida State University, FL, USA.

Abstract

Medicaid waivers have been a principal tool of innovation in health policy in the US since at least the mid 1970s. As Republicans seek to give the states more flexibility in their implementation and management of both Medicaid and the Affordable Care Act or its replacement, waiver authority is likely to be one of the key work arounds for avoiding political barriers in the US Senate. While block-granting Medicaid may require 60 senate votes, waiver authority already exists in both Medicaid law and the Affordable Care Act. Waivers also have great potential for application in other federal nations. Yet there is no theory to explain the way the application and review process evolves or the factors likely to shape the outcome. After a discussion of the theoretical underpinnings of what we call 'negotiated federalism', we apply it to examples of Medicaid waivers to see if the theory's key elements - politics, party congruence, leverage, credit taking and experience - offer a useful perspective on this federal-state interaction so important to health policy.

"Should the FDA evaluate and oversee the truthfulness and veracity of drug product claims or should this be left to decisions by the courts and/or self-regulation by manufacturers? This question now extends to EHRs..."

In Reply—Electronic Health Records and Drugs Prescribed for Off-label Indications

Tim K. Mackey, MAS, PhD
University of California, San Diego, CA
Bryan A. Liang, MD, JD, PhD
Global Health Policy Institute, San Diego, CA

"Importantly, the problem identified by Dr Porter is emblematic of a larger battle in our medical legal and regulatory environment. As detailed in our June commentary in this journal on the court decision Amarin v FDA1 and as discussed in subsequent commentaries in journals such as the New England Journal of Medicine2 and JAMA Internal Medicine,3 recent court decisions have consistently eroded the FDA's regulatory authority over off-label promotion activities. This is happening despite hundreds of millions of dollars in off-label fraud and abuse settlements successfully prosecuted by the US Department of Justice, many of which involved egregious off-label marketing that has directly endangered patients (such as promoting a drug for an indication or patient population with a “black box” warning).4

At the heart of this debate is a simple question: Should the FDA evaluate and oversee the truthfulness and veracity of drug product claims or should this be left to decisions by the courts and/or self-regulation by manufacturers? This question now extends to EHRs, with court decisions like Amarin stripping away the FDA's ability to vigorously regulate how commercial entities like EHR data vendors market and disseminate off-label information. It also raises a more fundamental issue: should commercial free speech be constitutionally protected, even when it potentially endangers public health?

Collectively, we argue that leaving important scientific and clinical decisions about off-label promotion in the hands of commercially driven entities endangers the checks and balances of the FDA's drug approval processes that emphasize safety and efficacy. It also compromises the important role of clinicians as the learned intermediary because the easing of off-label regulation, the retreat of FDA oversight, and more selective US Department of Justice enforcement will likely lead to the proliferation of poor-quality off-label information that clinicians will have to navigate and interpret."


The Views of Clergy Regarding Ethical Controversies in Care at the End of Life

 2017 Aug 14. pii: S0885-3924(17)30366-4. doi: 10.1016/j.jpainsymman.2017.05.009. [Epub ahead of print]

The Views of Clergy Regarding Ethical Controversies in Care at the End of Life.

Author information

1
Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA; Initiative on Health, Religion, and Spirituality within Harvard, Boston, MA. Electronic address: michael_balboni@dfci.harvard.edu.
2
Department of Biostatistics, Brown University, Providence, RI.
3
Harvard Medical School Center for Bioethics, Boston, MA.
4
Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA; Division of Palliative Medicine. Department of Medicine, Brigham and Women's Hospital, Boston, MA.
5
University of Chicago Medical and Divinity Schools, Chicago, IL.
6
Initiative on Health, Religion, and Spirituality within Harvard, Boston, MA; Departments of Epidemiology and Biostatistics, Harvard School of Public Health, Boston, MA.
7
Initiative on Health, Religion, and Spirituality within Harvard, Boston, MA; Departments of Radiation Oncology and Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA; Brigham and Women's Hospital, Boston, MA.

Abstract

CONTEXT:

While religion often informs ethical judgments, little is known about the views of American clergy regarding controversial end-of-life ethical issues including allowing to die and physician-aid in dying or physician-assisted suicide (PAD/PAS).

OBJECTIVE:

To describe the views of U.S. clergy concerning allowing to die and PAD/PAS.

METHODS:

A survey was mailed to 1665 nationally representative clergy between 8/2014 to 3/2015 (60% response rate). Outcome variables included beliefs about whether the terminally ill should ever be "allowed to die" and moral/legal opinions concerning PAD/PAS.

RESULTS:

Most U.S. clergy are Christian (98%). Clergy agreed that there are circumstances in which the terminally ill should be "allowed to die" (80%). A minority agreed that PAD/PAS was morally (28%) or legally (22%) acceptable. Mainline/Liberal Christian clergy were more likely to approve of the morality (56%) and legality (47%) of PAD/PAS, in contrast to all other clergy groups (6%-17%). Greater end-of-life medical knowledge was associated with moral disapproval of PAD/PAS (adjusted odds ratio [AOR], 1.51; 95% CI, 1.04 to 2.19), p=0.03). Those reporting distrust in healthcare were less likely to oppose legalization of PAD/PAS (AOR 0.93; 95% CI, 0.87 to 0.99, p<0.02). Religious beliefs associated with disapproval of PAD/PAS, included "life's value is not tied to the patient's quality of life" (AOR 2.12; 95% CI, 0.1.49 to 3.03, p<0.001) and "only God numbers our days" (AOR 2.60; 95% CI, 1.77 to 3.82, p<0.001).

CONCLUSION:

Most U.S. clergy approve of "allowing to die" but reject the morality or legalization of PAD/PAS. Respectful discussion in public discourse should consider rather than ignore underlying religious reasons informing end-of-life controversies.

Newsflash: Communism was not "...a boon for free expression in the Eastern Bloc..."

The Forgotten World of Communist Bookstores

Communist bookstores were one of the most important public spaces for radicals in twentieth century America.




"Despite these challenges, surviving communist bookstores enjoyed a small renaissance in the late 1960s and 1970s. The New Communist Movement— an ultra-left offshoot of the New Left — launched an array of Marxist-Leninist organizations and sought to radicalize existing unions in these years. But in the 1980s and ’90s, two unforeseen transformations overwhelmed this modest uptick in activity.
First, and most dramatically, nearly twenty Communist governments fell in a three-year-stretch. The Soviets had directed American Communists and overseen their bookstores for decades, so the Berlin Wall’s collapse and the implosion of state socialism — despite being a boon for free expression in the Eastern Bloc — had a deleterious effect on communist bookstores in the US."

"...excess calories..."

UK Targets Calorie Reduction In Popular Food Items To Combat Childhood Obesity


"What they plan to do is to set targets to reduce the amount of excess calories in popular food items. This includes ready-to-eat meals, burgers, pizzas, and other savory food items.
To clarify, accepting and following the target caloric reductions will be merely voluntary for the food industry. However, officials at the government's advisory board are prepared to legislate accordingly should they refuse to respond."

Wednesday, August 16, 2017

Medical Liability - Prospects for Federal Reform

 2017 May 11;376(19):1806-1808. doi: 10.1056/NEJMp1701174. Epub 2017 Mar 29.

Medical Liability - Prospects for Federal Reform.

Author information

1
From Stanford Law School (M.M.M., D.M.S.) and the Departments of Medicine (D.M.S.) and Health Research and Policy (M.M.M.), Stanford University School of Medicine, Stanford, CA; and the Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston (A.K.).


"How promising are these reform ideas? Safe harbors for physicians who adhere to evidence-based practice is an idea that dates back to the 1980s. It has attracted interest from health care provider groups, health insurers, and health policy experts. Theoretically, it could reduce the practice of defensive medicine while encouraging wider adherence to guidelines — responses that harmonize with improving the quality of care.
However, the limited evidence base does not suggest that guideline-based safe harbors are effective in reducing liability claims or costs (see table). In states that have tried them, they do not appear to have had an impact, and the programs have withered. One key reason is the surprisingly small overlap between aspects of care disputed in malpractice litigation and aspects addressed by CPGs. One recent simulation study showed that safe harbors would have eliminated defendants’ malpractice payments in less than 1% of claims; in 85% of cases no guideline applied, and when one did, physicians generally prevailed regardless.3 A surge in availability and use of CPGs could enlarge the overlap, but the effects of safe harbors on liability costs would probably be modest at best. Nevertheless, safe harbors are appealing for other reasons: they promote quality of care and safety by providing incentives for practicing evidence-based medicine, and they may accelerate claim resolution."

Tuesday, August 15, 2017

FCC Chair Ajit Pai "...seems to have never met a regulation he didn’t want to kill..."

Congress starts work on net neutrality — but does it understand the issue?

"Puushed by its new Republican chairman, Ajit Pai, who seems to have never met a regulation he didn’t want to kill, the Federal Communications Commission has proposed repealing the tough net neutrality rules his predecessor, Democrat Tom Wheeler, adopted in 2015 and replacing them with … well, that part’s not clear. One possibility Pai floated is to have the FCC punt oversight of broadband providers such as Comcast and AT&T to the Federal Trade Commission, which can do little more to first-time offenders than tell them they’ll be punished if they transgress again."

HT:LR

Saturday, August 12, 2017

Immunohistochemistry of Pulmonary Biomarkers: A Perspective From Members of the Pulmonary Pathology Society

 2017 Jul 7. doi: 10.5858/arpa.2017-0106-SA. [Epub ahead of print]

Immunohistochemistry of Pulmonary Biomarkers: A Perspective From Members of the Pulmonary Pathology Society.

Abstract

The use of immunohistochemistry for the determination of pulmonary carcinoma biomarkers is a well-established and powerful technique. Immunohistochemisty is readily available in pathology laboratories, is relatively easy to perform and assess, can provide clinically meaningful results very quickly, and is relatively inexpensive. Pulmonary predictive biomarkers provide results essential for timely and accurate therapeutic decision making; for patients with metastatic non-small cell lung cancer, predictive immunohistochemistry includes ALK, (ROS1, EGFR in Europe), and programmed death ligand-1 (PD-L1) testing. Handling along proper methodologic lines is needed to ensure patients receive the most accurate and representative test outcomes.

“Elvis could focus better than any artist I ever worked with..."

Elvis Presley’s friends feel love, pain, 40 years after his death


Putnam, a bass guitarist and member of the renowned Muscle Shoals rhythm section, played on 120 Presley songs. He recalls how much energy Presley displayed during the marathon recording sessions that ran all night at RCA Studio B in Nashville in 1970.

“Elvis could focus better than any artist I ever worked with,” Putnam said. “He would learn a new song in five to 10 minutes, and was ready to deliver a killer vocal on the first take. That was very unusual.”

"Insurers attempting to price their plans and determine which states and counties they will service next year face a great deal of uncertainty."

An Early Look at 2018 Premium Changes and Insurer Participation on ACA Exchanges


"Insurers attempting to price their plans and determine which states and counties they will service next year face a great deal of uncertainty. They must soon sign contracts locking in their premiums for the entire year of 2018, yet Congress or the Administration could make significant changes in the coming months to the law – or its implementation – that could lead to significant losses if companies have not appropriately priced for these changes. Insurers vary in the assumptions they make regarding the individual mandate and cost-sharing subsidies and the degree to which they are factoring this uncertainty into their rate requests."

"All the old nostrums about independence suddenly seemed like unaffordable luxuries."

When Silicon Valley Took Over Journalism

The pursuit of digital readership broke the New Republic—and an entire industry.

"At the beginning of this century, journalism was in extremis. Recessions, coupled with readers’ changing habits, prodded media companies to gamble on a digital future unencumbered by the clunky apparatus of publishing on paper. Over a decade, the number of newspaper employees dropped by 38 percent. As journalism shriveled, its prestige plummeted. One report ranked newspaper reporter as the worst job in America. The profession found itself forced to reconsider its very reasons for existing. All the old nostrums about independence suddenly seemed like unaffordable luxuries."

Eat right. Work out.

Exercise does so much for you. Why won’t it make you lose weight?


Exercise helps keep lost pounds off, but exercise alone can’t do the initial job of losing it.
“I think the role of exercise in weight loss is highly overrated,” says Marc Reitman, chief of the diabetes, endocrinology and obesity branch of the National Institute of Diabetes and Digestive and Kidney Diseases, or NIDDK. “I think it’s really great for being healthy, but I’m a strong believer that overeating is what causes obesity. To exercise your way out of overeating is impossible.”

Human Genome Editing: Science, Ethics, and Governance

Human Genome Editing: Science, Ethics, and Governance.

Editors

National Academies of Sciences, Engineering, and Medicine; National Academy of Medicine; National Academy of Sciences; Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations.

Source

Washington (DC): National Academies Press (US); 2017 Feb.

Excerpt

Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.

Rosie Roach

FROM DECEMBER 2015:


Funeral shrine celebrates fallen Texas A&M cockroach


Published 2:00 pm, Monday, December 21, 2015


"There has been a dead cockroach in the anthropology building's stairwell for at least two weeks," professor Michael Alvard wrote on Facebook on December 3, along with a picture of Rosie laid beside her mini-headstone. "Some enterprising person has now made her a little shrine."




Friday, August 11, 2017

Guidelines for Pathologic Diagnosis of Malignant Mesothelioma: 2017 Update of the Consensus Statement From the International Mesothelioma Interest Group

Guidelines for Pathologic Diagnosis of Malignant Mesothelioma: 2017 Update of the Consensus Statement From the International Mesothelioma Interest Group.


 2017 Jul 7. doi: 10.5858/arpa.2017-0124-RA. [Epub ahead of print]

Abstract

CONTEXT:

- Malignant mesothelioma (MM) is an uncommon tumor that can be difficult to diagnose.

OBJECTIVE:

- To provide updated, practical guidelines for the pathologic diagnosis of MM.

DATA SOURCES:

- Pathologists involved in the International Mesothelioma Interest Group and others with an interest and expertise in the field contributed to this update. Reference material included up-to-date, peer-reviewed publications and textbooks.

CONCLUSIONS:

- There was discussion and consensus opinion regarding guidelines for (1) distinguishing benign from malignant mesothelial proliferations (both epithelioid and spindle cell lesions), (2) cytologic diagnosis of MM, (3) recognition of the key histologic features of pleural and peritoneal MM, (4) use of histochemical and immunohistochemical stains in the diagnosis and differential diagnosis of MM, (5) differentiating epithelioid MM from various carcinomas (lung, breast, ovarian, and colonic adenocarcinomas, and squamous cell and renal cell carcinomas), (6) diagnosis of sarcomatoid MM, (7) use of molecular markers in the diagnosis of MM, (8) electron microscopy in the diagnosis of MM, and (9) some caveats and pitfalls in the diagnosis of MM. Immunohistochemical panels are integral to the diagnosis of MM, but the exact makeup of panels employed is dependent on the differential diagnosis and on the antibodies available in a given laboratory. Depending on the morphology, immunohistochemical panels should contain both positive and negative markers for mesothelial differentiation and for lesions considered in the differential diagnosis. Immunohistochemical markers should have either sensitivity or specificity greater than 80% for the lesions in question. Interpretation of positivity generally should take into account the localization of the stain (eg, nuclear versus cytoplasmic) and the percentage of cells staining (>10% is suggested for cytoplasmic and membranous markers). Selected molecular markers are now being used to distinguish benign from malignant mesothelial proliferations. These guidelines are meant to be a practical diagnostic reference for the pathologist; however, some new pathologic predictors of prognosis and response to therapy are also included.

Ready Player One: Proponents of Later School Start Times See Momentum

Proponents of Later School Start Times See Momentum

With students getting ready to hit the books again, some will be getting some more sleep first.



"A key factor in the push for later school start times is the changing sleep pattern of children when they reach puberty. Research shows that as a result of shifting melatonin levels, adolescents need an increased amount of sleep, can have trouble falling asleep before 11 p.m. and function best when allowed to sleep until 8 a.m. or later."

Sunday, August 6, 2017

Nannystate: Toddlers to be banned from having fruit juice at nursery

JUICE NO MORE 

Toddlers to be banned from having fruit juice at nursery in new crackdown on child obesity


Experts fear the young kids may not get their recommended five-a-day fruit and veg intake


"The new menus recommend that nurseries only offer water or milk to youngsters at meal times.
Before the shakeup, The Children’s Food Trust – which drew up the new guidelines – said kids could have some juice at meals, if diluted with water."
























Overfat

Is 'overfat' the new obesity?



What is overfat?

"Overfat is a term created to describe if you have a body fat level that can actually hurt your health. Even people who are considered 'normal weight' or 'non-obese' by traditional standards can fall into this category.

The authors of this new study argue that BMI misses about 50% of the people who still have dangerous amounts of fat. Those are typically people who have the proverbial beer belly, but are otherwise in decent shape."

"...the well-documented need for effective clinical communication tools and therapeutic interventions where a child's mother is diagnosed with life-threatening gynecological cancer."

 2017 Aug 4. doi: 10.1089/jpm.2017.0058. [Epub ahead of print]

My Kite Will Fly: Improving Communication and Understanding in Young Children When a Mother Is Diagnosed with Life-Threatening Gynecological Cancer.

Author information

1
1 Department of Obstetrics and Gynecology, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne , Parkville, Victoria, Australia .
2
2 Social Work and Cultural Diversity, The Royal Melbourne Hospital , Parkville, Victoria, Australia; Department of Cancer Experience Research, Peter MacCallum Centre, Parkville, Victoria, Australia .
3
3 Department of Social Work, Faculty of Medicine, Dentristry and Health Sciences, The University of Melbourne , Parkville, Victoria, Australia .
4
4 Department of Social Work, Faculty of Medicine Nursing and Health Sciences, Monash University and Monash Health , Clayton, Victoria, Australia .
5
5 My Kite Will Fly Research Project, The Writing Practice , Melbourne, Victoria, Australia .
6
6 Centre for Women's Mental Health, Royal Women's Hospital , Parkville, Victoria, Australia .
7
7 Department of Psychiatry, The University of Melbourne , Parkville, Victoria, Australia .
8
8 International Gynecologic Cancer Society (IGCS) , Louisville, Kentucky.

Abstract

STUDY AIMS:

The My Kite Will Fly (MKWF) research program is built on the well-documented need for effective clinical communication tools and therapeutic interventions where a child's mother is diagnosed with life-threatening gynecological cancer.

METHODS:

The Dignity Model and Child-Centered approach were two key study foundations in this pilot cohort. Quantitative survey and qualitative semistructured methods were employed to gather data from patient families at three distinct phases: Diagnosis, Treatment, and Palliative care. Participants were identified from patient groups at The Royal Women's Hospital and Peter MacCallum Cancer Center, Melbourne, Australia. A purposive sample (n = 36 children) (24 girls and 12 boys aged between 3 and 12 years) drawn from 19 families completed structured art therapy workbook activities. The principal researcher and a specialist educational assistant undertook cross-case thematic analysis of all interviews and children's drawings.

RESULTS:

Five central themes were profiled in six illustrative case studies. Interviews with all families (n = 19) showed 86.1% positive evaluation of the MKWF workbook template at diagnosis. During treatments, 66.6% of parents reported better understanding of the chemotherapy process and better communication with younger family members. At palliative care, 97.3% of families reported stabilization of family routines and improved illness coping. Exit interviews with six children and surviving parents (n = 4) showed that the program substantially prepared them for parental bereavement.

CONCLUSIONS:

Results from this pilot cohort confirm the importance of enhanced parent-child communication and stabilized family routines. Current results provide an important platform for future evaluative research among larger patient-family populations across multisite oncology settings.

Saturday, August 5, 2017

Think opera's boring?

Think opera's boring?

Still my favorite Gangnam Style parody

Houston, what's the problem?

Poor sleep habits increase risk for obesity, study says



Poor sleep habits increase risk for obesity, study says


According to study co-author Greg Potter, "The number of people with obesity worldwide has more than doubled since 1980. Obesity contributes to the development of many diseases, most notably type 2 diabetes. Understanding why people gain weight has crucial implications for public health."


Combination Therapy of Radiotherapy and Anti-PD-1/PD-L1 Treatment in Non-Small-cell Lung Cancer

 2017 Jul 6. pii: S1525-7304(17)30202-4. doi: 10.1016/j.cllc.2017.06.015. [Epub ahead of print]

Combination Therapy of Radiotherapy and Anti-PD-1/PD-L1 Treatment in Non-Small-cell Lung Cancer: A Mini-review.

Author information

1
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
2
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. Electronic address: gouji104kawa@gmail.com.

Abstract

Immune checkpoint inhibitors against programmed cell death-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) are a standard pharmacologic therapy for patients with non-small-cell lung cancer (NSCLC). Substantial data have accumulated in recent years showing that radiotherapy combined with immunotherapy is more effective than monotherapy alone. Preclinical studies have shown that PD-L1 expression is upregulated on tumor cells after radiotherapy, resulting in the synergistically enhanced antitumor effect of irradiation and PD-L1 blockade. In the clinical setting, patients receiving radiotherapy before anti-PD-1 treatment have had a significantly better prognosis than those who have not undergone radiotherapy. In the present report, we reviewed previous studies of the combination of radiotherapy and anti-PD-1/PD-L1 treatment for NSCLC. In addition, we report our case of a patient whose PD-L1 expression gradually increased in brain metastases from NSCLC after repeated radiotherapy. In the perspectives portion, we focused on the questions of how to integrate radiotherapy into anti-PD-1/PD-L1 agent regimens and described several ongoing clinical trials.

Human Germline Genome Editing

 2017 Aug 3;101(2):167-176. doi: 10.1016/j.ajhg.2017.06.012.

Human Germline Genome Editing.

Author information

1
Department of Genetics and Stanford Center for Biomedical Ethics, School of Medicine, Stanford University, Stanford, CA 94305, USA. Electronic address: kormond@stanford.edu.
2
Vanderbilt Genetics Institute and Department of Molecular Physiology and Biophysics, Vanderbilt University, Nashville, TN 37232, USA.
3
American Society of Human Genetics, Bethesda, MD 20814, USA.
4
Li Ka Shing Knowledge Institute of St. Michael's Hospital, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON M5B 1W8, Canada.
5
Division of Genomics and Society, National Human Genome Research Institute, Bethesda, MD 20892, USA.
6
Genomic Medicine Institute, Geisinger Health System, Danville, PA 17822, USA; National Society of Genetic Counselors.
7
Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital and Research Institute, Seattle, WA 98101, USA; Division of Bioethics, Department of Pediatrics, University of Washington, Seattle, WA 98101, USA.
8
National Society of Genetic Counselors; Joan H. Marks Graduate Program in Human Genetics, Sarah Lawrence College, Bronxville, NY 10708, USA.
9
Dr. John T. Macdonald Foundation Department of Human Genetics and Institute for Bioethics and Health Policy, University of Miami Miller School of Medicine, Miami, FL 33136, USA.
10
Society and Ethics Research Group, Connecting Science, Wellcome Genome Campus, Hinxton, Cambridge CB10 1SA, UK; Association of Genetic Nurses and Counsellors.
11
Cardiovascular Institute, Departments of Medicine and Genetics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.
12
Center for Research on Genomics and Global Health, National Human Genome Research Institute, Bethesda, MD 20892, USA; International Genetic Epidemiology Society.
13
Provincial Health Service Authority of British Columbia and Department of Medical Genetics, University of British Columbia, BC V6H 3N1, Canada; Canadian Association of Genetic Counsellors.

Abstract

With CRISPR/Cas9 and other genome-editing technologies, successful somatic and germline genome editing are becoming feasible. To respond, an American Society of Human Genetics (ASHG) workgroup developed this position statement, which was approved by the ASHG Board in March 2017. The workgroup included representatives from the UK Association of Genetic Nurses and Counsellors, Canadian Association of Genetic Counsellors, International Genetic Epidemiology Society, and US National Society of Genetic Counselors. These groups, as well as the American Society for Reproductive Medicine, Asia Pacific Society of Human Genetics, British Society for Genetic Medicine, Human Genetics Society of Australasia, Professional Society of Genetic Counselors in Asia, and Southern African Society for Human Genetics, endorsed the final statement. The statement includes the following positions. (1) At this time, given the nature and number of unanswered scientific, ethical, and policy questions, it is inappropriate to perform germline gene editing that culminates in human pregnancy. (2) Currently, there is no reason to prohibit in vitro germline genome editing on human embryos and gametes, with appropriate oversight and consent from donors, to facilitate research on the possible future clinical applications of gene editing. There should be no prohibition on making public funds available to support this research. (3) Future clinical application of human germline genome editing should not proceed unless, at a minimum, there is (a) a compelling medical rationale, (b) an evidence base that supports its clinical use, (c) an ethical justification, and (d) a transparent public process to solicit and incorporate stakeholder input.