Personhood Seeking New Life with Republican Control

Just three days prior to the inauguration of Donald J. Trump as President of the United States, Representative Jody B. Hice (R-GA) introduced the Sanctity of Human Life Act (H R. 586), which, if enacted, would provide that the rights associated with legal personhood begin at fertilization. Then, in October 2017, the Department of Health and Human Services released its draft strategic plan, which identifies a core policy of protecting Americans at every stage of life, beginning at conception. While often touted as a means to outlaw abortion, protecting the lives of single-celled zygotes may also have implications for the practice of reproductive medicine and research. Indeed, such personhood efforts stand apart and distinct from more incremental attempts to restrict abortion that target the abortion procedure and those who would perform it. While personhood efforts have not been successful to date at either the state or federal levels, abortion opponents may find a friend in President Trump and his Supreme Court nominees. What is more, because the recent decision by the Court in Whole Woman\u27s Health v. Hellerstedt makes it more difficult for states to impose incremental restrictions on the abortion procedure, restrictions focused on the status of the unborn may assume increasing importance. Personhood rhetoric is often seen in proceedings involving the disposition of unused embryos and in laws that restrict access to abortion on the basis of gender, race, or disability. Laws outlawing abortion on the basis of fetal pain are also on the rise. With so much uncertainty surrounding the political landscape, this Article places the personhood movement in historical context with other antiabortion strategies. This Article further explores the theoretical underpinnings of the personhood movement and considers its future prospects with regard to abortion and other reproductive services

Germ-Line Gene Editing and Congressional Reaction in Context: Learning From Almost 50 Years of Congressional Reactions to Biomedical Breakthroughs

On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs—Recombinant DNA, in vitro fertilization, Cloning, Stem Cells—to better analyze how Congress is, and should, regulate this exciting and promising science

Handle with Care: The WHO Report on Human Genome Editing

On July 14, 2021, the Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing of the World Health Organization released a much-anticipated report comprised of two separate documents, Human Genome Editing: Recommendations and Human Genome Editing: A Framework for Governance. The committee also released a “position paper” on both. These documents—collectively referred to as the WHO Report on Human Genome Editing—complement a recently issued report by the International Commission on the Clinical Use of Human Germline Genome Editing, a joint effort of the National Academy of Medicine, the National Academy of Sciences, and the Royal Society from September 2020. Other significant reports were issued earlier by the Nuffield Council on Bioethics, the German Ethics Council, and a host of others. The WHO report, therefore, stands along-side a long list—more than five dozen—of other, similar re-ports about the ethics of human germline genome editing. But the WHO report also stands out in several respects. It is far more synoptic in scope than its predecessors, recognizing the multidimensional (and multijurisdictional) nature of governing human genome editing. It also contains recommendations for governance mechanisms that are far more nuanced than those in prior attempts. These include using intellectual property licensing as a private governance tool, an instrument largely unexplored in earlier reports. In addition, the WHO report is among the first to explicitly contemplate a world in which human germline genome editing is readily available, and it identifies a list of governance questions that regulators, developers, and users of the technology should consider in the technology’s implementation. Rather than adopting a mechanistic framework of color-coded permissibilities or prohibitions, the WHO report suggests that ethical assessments of human germline genome editing are deeply complex and surprisingly fragile, that the technology, rather than being accepted in some circumstances and banned in others, should be handled with care.Ope

Governing Human Germline Editing Through Patent Law

In the wake of the heritable human genome editing (HHGE) experiments carried out by He Jiankui in China, widely condemned as unethical and scientifically ill grounded, attention has shifted to questions concerning hard law and regulation. The World Health Organization (WHO) recently released a report along with several auxiliary documents exploring international governance tools for human genome engineering. However, as long as such governance occurs only at the national legal level, the possibility of medical tourism to circumvent domestic prohibitions remains a risk. In this Viewpoint, we articulate the case for patent licensing as international governance instrument, as well as discussing patent law's limits.Ope

Gene Editing Sperm and Eggs (not Embryos): Does it Make a Legal or Ethical Difference?

Heritable, human genome editing constitutes one of the most contentious issues facing science policy. This was starkly illustrated by Dr. He’s unsafe, unethical, and irresponsible editing of twin girls’ embryos in an attempt to confer HIV immunity. The hubris of those experiments stands in contrast to calls for a regulated pathway from the U.S.’s National Academies and the U.K.’s Nuffield Council. But in all of the public discussion of the topic, the focus has been on editing embryos. What about editing sperm or eggs? Weighed down by technical, statutory, as well as sectarian challenges, the prospect of editing a human embryo’s genome at fertilization still remains a long-term goal. Mindful of this reality, the 2015 International Summit on Human Gene Editing reported the editing of mouse spermatogonial stem cells followed by testicular transplantation, resulting in the repair of a cataract-causing mutation. Further experimental work in this area, however, has proven limited. Similarly limited efforts have characterized editing eggs, although the editing of gametes is likely to flourish as the prospect of stem cell-derived gametes becomes reality. This outcome is bound to shift the focus from genome editing the embryo to its antecedent gametes. This will likely increase control of the genome editing process, including eliminating problems of embryonic mosaicism. In this paper we discuss how the editing of sperm and eggs differs from embryos from a bioethical and U.S. legal perspective.Open Restriction set for Item 118072 on 2021-08-05T15:50:13Z with date null by [email protected] by Jacob Sherkow ([email protected]) on 2021-08-05T15:56:56Z No. of bitstreams: 1 Cohen, Sherkow, Adashi - 2020 - Gene Editing Sperm and Eggs (not Embryos) Does it Make a Legal or Ethical Difference.pdf: 133139 bytes, checksum: 197054b9af3ca135a5b3a84b686b58f7 (MD5)Approved for entry into archive by Ayla Kenfield ([email protected]) on 2021-08-05T16:21:37Z (GMT) No. of bitstreams: 1 Cohen, Sherkow, Adashi - 2020 - Gene Editing Sperm and Eggs (not Embryos) Does it Make a Legal or Ethical Difference.pdf: 133139 bytes, checksum: 197054b9af3ca135a5b3a84b686b58f7 (MD5)Made available in DSpace on 2021-08-05T16:21:37Z (GMT). No. of bitstreams: 1 Cohen, Sherkow, Adashi - 2020 - Gene Editing Sperm and Eggs (not Embryos) Does it Make a Legal or Ethical Difference.pdf: 133139 bytes, checksum: 197054b9af3ca135a5b3a84b686b58f7 (MD5) Previous issue date: 2020-10-07Ope

Insulin: Its role in the central control of reproduction

Insulin has long been recognized as a key regulator of energy homeostasis via its actions at the level of the brain, but in addition, plays a role in regulating neural control of reproduction. In this review, we consider and compare evidence from animal models demonstrating a role for insulin for physiological control of reproduction by effects on GnRH/LH secretion. We also review the role that insulin plays in prenatal programming of adult reproduction, and consider specific candidate neurons in the adult hypothalamus by which insulin may act to regulate reproductive function. Finally, we review clinical evidence of the role that insulin may play in adult human fertility and reproductive disorders. Overall, while insulin appears to have a significant impact on reproductive neuroendocrine function, there are many unanswered questions regarding its precise sites and mechanisms of action, and their impact on developing and adult reproductive neuroendocrine function

Ovarian follicular cells have innate immune capabilities that modulate their endocrine function

Oestrogens are pivotal in ovarian follicular growth, development and function, with fundamental roles in steroidogenesis, nurturing the oocyte and ovulation. Infections with bacteria such as Escherichia coli cause infertility in mammals at least in part by perturbing ovarian follicle function, characterised by suppression of oestradiol production. Ovarian follicle granulosa cells produce oestradiol by aromatisation of androstenedione from the theca cells, under the regulation of gonadotrophins such as FSH. Many of the effects of E. coli are mediated by its surface molecule lipopolysaccharide (LPS) binding to the Toll-like receptor-4 (TLR4), CD14, MD-2 receptor complex on immune cells, but immune cells are not present inside ovarian follicles. The present study tested the hypothesis that granulosa cells express the TLR4 complex and LPS directly perturbs their secretion of oestradiol. Granulosa cells from recruited or dominant follicles are exposed to LPS in vivo and when they were cultured in the absence of immune cell contamination in vitro they produced less oestradiol when challenged with LPS, although theca cell androstenedione production was unchanged. The suppression of oestradiol production by LPS was associated with down-regulation of transcripts for aromatase in granulosa cells, and did not affect cell survival. Furthermore, these cells expressed TLR4, CD14 and MD-2 transcripts throughout the key stages of follicle growth and development. It appears that granulosa cells have an immune capability to detect bacterial infection, which perturbs follicle steroidogenesis, and this is a likely mechanism by which ovarian follicle growth and function is perturbed during bacterial infection

Sociodemographic and geographic characteristics associated with patient visits to osteopathic physicians for primary care

<p>Abstract</p> <p>Background</p> <p>Health care reform promises to dramatically increase the number of Americans covered by health insurance. Osteopathic physicians (DOs) are recognized for primary care, including a "hands-on" style with an emphasis on patient-centered care. Thus, DOs may be well positioned to deliver primary care in this emerging health care environment.</p> <p>Methods</p> <p>We used data from the National Ambulatory Medical Care Survey (2002-2006) to study sociodemographic and geographic characteristics associated with patient visits to DOs for primary care. Descriptive analyses were initially performed to derive national population estimates (NPEs) for overall patient visits, primary care patient visits, and patient visits according to specialty status. Osteopathic and allopathic physician (MD) patient visits were compared using cross-tabulations and multiple logistic regression to compute odds ratios (ORs) and 95% confidence intervals (CIs) for DO patient visits. The latter analyses were also conducted separately for each geographic characteristic to assess the potential for effect modification based on these factors.</p> <p>Results</p> <p>Overall, 134,369 ambulatory medical care visits were surveyed, representing 4.6 billion (NPE) ± 220 million (SE) patient visits when patient visit weights were applied. Osteopathic physicians provided 336 million ± 30 million (7%) of these patient visits. Osteopathic physicians provided 217 million ± 21 million (10%) patient visits for primary care services; including 180 million ± 17 million (12%) primary care visits for adults (21 years of age or older) and 37 million ± 5 million (5%) primary care visits for minors. Osteopathic physicians were more likely than MDs to provide primary care visits in family and general medicine (OR, 6.03; 95% CI, 4.67-7.78), but were less likely to provide visits in internal medicine (OR, 0.37; 95% CI, 0.24-0.58) or pediatrics (OR, 0.21; 95% CI, 0.11-0.40). Overall, patients in the pediatric and geriatric ages, Blacks, Hispanics, and persons in the South and West were less likely to utilize DOs, although there was some evidence of effect modification according to United States Census region.</p> <p>Conclusions</p> <p>Health care reform provides unprecedented opportunities for DOs to reach historically underserved populations and to overcome the "pediatric primary-care paradox."</p

The association of breast mitogens with mammographic densities

Radiologically dense breast tissue (mammographic density) is strongly associated with risk of breast cancer, but the biological basis for this association is unknown. In this study we have examined the association of circulating levels of hormones and growth factors with mammographic density. A total of 382 subjects, 193 premenopausal and 189 postmenopausal, without previous breast cancer or current hormone use, were selected in each of five categories of breast density from mammography units. Risk factor information, anthropometric measures, and blood samples were obtained, and oestradiol, progesterone, sex hormone binding globulin, growth hormone, insulin-like growth factor-I and its principal binding protein, and prolactin measured. Mammograms were digitised and measured using a computer-assisted method. After adjustment for other risk factors, we found in premenopausal women that serum insulin-like growth factor-I levels, and in postmenopausal women, serum levels of prolactin, were both significantly and positively associated with per cent density. Total oestradiol and progesterone levels were unrelated to per cent density in both groups. In postmenopausal women, free oestradiol (negatively), and sex hormone binding globulin (positively), were significantly related to per cent density. These data show an association between blood levels of breast mitogens and mammographic density, and suggest a biological basis for the associated risk of breast cancer