StemCell Therapy

Background. While assisted reproductive technology (ART), including in vitro fertilization has given hope to millions of couples suffering from infertility, it has also introduced countless ethical, legal, and social challenges. The objective of this paper is to identify the aspects of ART that are most relevant to present-day society and discuss the multiple ethical, legal, and social challenges inherent to this technology. Scope of Review. This paper evaluates some of the most visible and challenging topics in the field of ART and outlines the ethical, legal, and social challenges they introduce. Major Conclusions. ART has resulted in a tectonic shift in the way physicians and the general population perceive infertility and ethics. In the coming years, advancing technology is likely to exacerbate ethical, legal, and social concerns associated with ART. ART is directly challenging society to reevaluate the way in which human life, social justice and equality, and claims to genetic offspring are viewed. Furthermore, these issues will force legal systems to modify existing laws to accommodate the unique challenges created by ART. Society has a responsibility to ensure that the advances achieved through ART are implemented in a socially responsible manner.

ART is currently a commonplace technology that has successfully treated millions of infertile couples the world over. However, the explosion of this technology has introduced a myriad of new social, ethical, and legal challenges. This paper evaluates some of the most visible and challenging topics in the field of ART and outlines the ethical, legal and social challenges they introduce.

Infertility has traditionally been an area of medicine in which physicians had limited means to help their patients. The landscape of this field changed dramatically with the announcement of the birth of Louise Brown in 1978 through in vitro fertilization (IVF). This historic moment was eloquently encapsulated by Howard Jones who observed Eleven forty-seven p.m. Tuesday, July 25, 1978, was surely a unique moment in the life of Patrick Steptoe. This was the hour and minute he delivered Louise Brown, the worlds first baby, meticulously, lovingly, and aseptically conceived in the laboratory, but popularly referred to as the worlds first test tube baby [1]. The importance of this birth to scientists, clinicians, and most particularly infertile patients throughout the world cannot be overstated. In several short decades, IVF has exploded in availability and use throughout the world.

Worldwide, more than 70 million couples are afflicted with infertility [2]. Since the first successful IVF procedure in 1978 [3], the use of this and related technologies has expanded to become commonplace around the globe. Over the past decade, the use of ART services has increased at a rate of 510% annually [4, 5].

In 1996, approximately 60,000 IVF cycles were initiated in the United States with approximately 17,000 clinical pregnancies and 14,000 live births [6]. Currently, IVF accounts for approximately 1% of all live births in the United States [6]. As of 2009, 3.4 million children have been born worldwide after ART treatment, and ART utilization is currently increasing at a rate of 510% annually in developed countries [4].

The widespread use of this technology throughout the world has prompted a desire by the public, governmental bodies, and professional organizations to create mechanisms that evaluate the utilization of ART. Advances in the arena of assisted reproductive technologies (ART) are accompanied by ethical and societal concerns. Legislation and professional societies have attempted to address these concerns for some time. For example, in 1986, the American Fertility Society first published guidelines for the ethical implementation of ART in the United States [7]. The dynamic nature of ART and the rapid evolution of the field result in constant paradigm shifts that require frequent and comprehensive evaluation by professional organizations and society alike.

In the 1980s, concerns surrounding ART focused on the safe administration of gonadotropins, transparency of pregnancy data from clinics, and addressing economic barriers to ART access. Some of these issues, such as reporting requirements for ART pregnancy results, have also been mandated with legislation in many nations [8]. Furthermore, ART reporting requirements generally include the number of embryos transferred. This measure has been extremely important in correlating the risk of multiple gestations with the transfer of 2 or more embryos. However, in many nations, reporting regulations are not accompanied by legislation defining practice patterns. For example, in the United States, while physicians are required to report the number of embryos transferred in an IVF cycle, there are no laws that state the allowed number of embryos transferred [8].

Through centralized mandatory reporting registries, general estimates of IVF activity are available in many nations. In an effort to define current IVF statistics and to make this information more transparent and available to patients, the Fertility Clinic Success Rate and Certification Act of 1992 was created in the United States [8]. This law requires clinics providing IVF in the United States to report specific information regarding IVF cycles, including pregnancy rates [6]. This reporting data is only reported on IVF cycle outcomes and does not include detailed information regarding the maternal or paternal medical history [6]. In other countries, similar national registries exist [5], making it possible to evaluate data from IVF cycles on both a national and international scale. A detailed accounting for ART reporting and regulations across the globe is available from the International Federation of Fertility Societies (IFFS) [5]. In their 2010 report, the IFFS reported ART outcomes data from 59 countries [5].

Such laws were implemented in an attempt to ensure that patients may be informed as to which clinics have superior ART pregnancy results. In some instances, however, this has led to some clinics cherry picking patients to improve their overall pregnancy results. This has actually become a barrier to receiving ART for many patients with a relatively poor pregnancy prognosis.

Federally mandated regulations, however, are not limited to registries. Increasingly, nations have enacted legislation that defines the parameters for acceptable practice of ART. The transfer of multiple embryos in a single cycle increases the rates of multiple births [9]. Because of the increased social costs and health risks associated with multiple births, legislation or guidelines from professional societies have been introduced in many countries restricting the number of embryos that may be transferred per IVF cycle in an effort to limit the incidence of multiple gestations [911]. Indeed, a study in the United Kingdom found that the total health care system costs following a singleton birth were 3313, 9122 following a twin birth and 32,354 following a triplet birth [9]. Additionally, the health risks, both to the mother and the infant, increase dramatically with increasing number of infants [9]. In the United States in 2007, the number of embryos transferred per cycle ranged from 2.2 in women under 35 to 3.1 in women over 40 years of age (CDC). Multiple birth rates in the United States in 2007 ranged from approximately 35% in women under 35 to 15% in women over the age of 40 [12]. In Europe, the approximate number of embryos transferred in the year 2006 was one (22%), two (57%), three (19%), or four (1.6%) [13]. In 2007, 79.2% of European births were singletons, with a twin rate of 19.9% and a triplet rate of 0.9% [5].

Pregnancy rates associated with IVF are high compared to those seen in the early days of the procedure. The current efficiency of IVF is more cost effective and efficacious in achieving pregnancy than other modalities, such as injectable gonadotropins coupled with intra uterine insemination (IUI), which traditionally some have preferred [14]. The increased efficiency of IVF has also resulted in an increased rate of multiple gestations. Recent data suggests that single embryo transfer, coupled with subsequent frozen embryo transfer, results in equivalent pregnancy rates compared with the transfer of multiple embryos, without an increase in multiple pregnancy rates [11]. Additionally, single embryo transfer would inherently decrease maternal and infant health risks associated with multiple gestation pregnancies [9]. Therefore, a trend toward single embryo transfer is likely to increase in the future.

Variability of legislation regulating IVF exists in different countries and even states/provinces within a single nation [6]. For example, in an effort to minimize multiple gestation pregnancies resulting from ART, some laws place limits on the number of embryos that may be transferred, cryopreserved, or fertilized per IVF cycle [5, 6, 15, 16]. In some cases, these regulations or fiscal pressures result in couples traveling across international border to obtain treatments that are unavailable in their native country [17]. This practice, known as cross-border reproductive care (CBRC), is thought to account for as much as 10% of the total IVF cycles performed worldwide [17, 18].

Perhaps one of the most obvious ethical challenges surrounding ART is the inequitable distribution of access to care. The fact that significant economic barriers to IVF exist in many countries results in the preferential availability of these technologies to couples in a position of financial strength [19]. The cost of performing ART per live birth varies among countries [4]. The average cost per IVF cycle in the United States is USD 9,266 [20]. However, the cost per live birth for autologous ART treatment cycles in the United States, Canada, and the United Kingdom ranged from approximately USD 33,000 to 41,000 compared to USD 24,000 to 25,000 in Scandinavia, Japan, and Australia [14]. The total ART treatment costs as a percentage of total healthcare expenditures in 2003 were 0.06% in the United States, 0.09% in Japan, and 0.25% in Australia [4]. Some have maintained that the cost for these cycles pales in comparison to the social advantages yielded by the addition of productive members of society [21]. This is especially true in societies that have a negative or flat population growth rate coupled with an aging population [21].

The funding structure for IVF/ART is highly variable among different nations. For example, no federal government reimbursement exists for IVF in the United States, although certain states have insurance mandates for ART [4, 19, 22]. Many other countries provide full or partial coverage through governmental insurance [4, 9]. In many instances, long waiting times for IVF through these government programs encourage couples to seek treatment in private fertility centers that accept remuneration directly from the patients [4, 23, 24]. In the United Kingdom, for example, only approximately 25% of all IVF cycles performed are funded by the National Health Service [9].

Preimplantation genetic screening (PGS) and diagnosis (PGD) offer the unique ability to characterize the genetic composition of embryos prior to embryo transfer. Given the recent successes of these technologies, the broader implementation of this technology in the future is likely. Although controversial, using PGD to choose embryos solely on the basis of gender is currently being practiced [25, 26]. Sex selection in the proper setting may offer a substantial health benefit. For example, choosing to transfer only embryos of a certain sex may confer a therapeutic benefit if used to avoid a known sex linked disorder. However, sex selection PGD purely for the preference of the parents could conceivably, if practiced on a large scale, skew the gender proportions in certain nations where one gender is culturally preferred.

In the near future, with refinements in microarray technology and the defining of genetic sequences associated with certain physical characteristics, it is conceivable that specific physical or mental characteristics may be evaluated to guide the decision as to which embryos to transfer. This possibility raises concerns on both ethical and practical levels. Of more concern is the possibility that in the future, technology will permit the manipulation of genetic material within an embryo. Rigorous public and scientific oversight of these technologies is vital to ensure that scientific advances are tempered with the best interests of society in mind.

Female fertility is well documented to decrease with age [27, 28]. Consequently, much research has been conducted aimed at preserving female fertility before advanced age is realized. Additionally, fertility preservation for individuals afflicted with cancer has important implications as often the chemotherapeutic agents used to treat cancer are toxic to the ovary and result in diminished ovarian reserve and reduced fertility. While techniques for freezing sperm and embryos are well established, techniques for freezing oocytes and ovarian tissue are still considered experimental [29]. Multiple techniques including oocyte cryopreservation and preservation of strips of ovarian cortex with subsequent reimplantation and stimulation have been described, with some pregnancy success [3033]. Fertility preservation for cancer patients using in vitro maturation (IVM), oocyte vitrification and the freezing of intact human ovaries with their vascular pedicles have also been reported [34]. As of 2008, more than 5 babies had been delivered through IVF following ovarian tissue transplantation [35]. Many have suggested that, prior to being treated for cancer, women should be offered fertility preservation measures as outlined above [34].

Recently, several laboratories have demonstrated the ability to successfully cryopreserve oocytes following an IVF cycle. These developments have profound implications. As the birth control pill gave women the ability to prevent pregnancy, oocyte cryopreservation may give women the flexibility to preserve their fertility potential, starting at a young age, while postponing childbearing. However, as this technology at the present time in many countries is generally only available to those with financial means. This poses ethical and social issues that will certainly see more attention in the future.

The use of donor gametes, either in the form of donor sperm or donor oocytes, is commonplace in ART. The use of donor sperm can be traced to the 1800s [36]. In the mid 1980s, oocyte donation was introduced [36]. In recent years, issues surrounding the use of donor gametes have become increasingly visible [37]. Women donating oocytes must undergo IVF. Due to the inherent medical risks associated with IVF, including ovarian hyperstimulation syndrome and surgical risks, a central concern of allowing women to be oocyte donors includes adequate informed consent [37]. Consent, in addition to outlining these medical risks, should include counseling regarding the emotional benefits and risks of donation with an emphasis that long-term data regarding these risks are lacking [37]. Additionally, it is considered an ethical prerequisite that oocyte donors participate voluntarily and without coercion or undue influence [38]. Some have expressed concern that financial compensation of oocyte donors may lead to exploitation as women may proceed with oocyte donation against their own best interests, given the inherent medical risks involved [39]. The concept of commodification, that any buying or selling of human gametes is inherently immoral, is an additional argument used against remunerating women serving as oocyte donors [39]. Due to the substantial controversy surrounding oocyte donation, especially the amount of financial compensation may be given to an oocyte donor, federal regulations governing this practice are constantly evolving and differ substantially from country to country [39].

Another ethical and legal issue surrounding the use of donated gametes is to what extent the anonymity of the donor should be preserved. The issue of anonymity as it relates to gamete and embryo donation is emotionally charged. Indeed, the ability of human beings to know their genetic roots is universally important, at the core of self identity. Either egg and sperm donors may choose to or not to be anonymous, though the vast majority in both groups generally chooses anonymity [40]. The American Society for Reproductive Medicine has identified four levels of gamete donor information sharing depending on the wishes of the donor and recipient parties [37]. Recently, however, there is, increasing consideration of the rights of offspring as it relates to donor gametes and anonymity [40]. Advocates for allowing either gamete donors or their offspring to break anonymity cite the medical advantages of sharing medical information with their genetic offspring, in the case of the donor, or learning about their genetic history directly, in the case of offspring [41, 42]. Others simply argue that both donors and offspring have an inherent right to meet and develop a relationship [43]. Recent court rulings suggest that these rights will become more visible in the future. For example, in the British case Rose v Secretary of State for Health [2002] EWHC 1593, the court ruled that based on the Human Rights Act, donor offspring could obtain information about their genetic parents despite previously established anonymity [43]. The ethical and legal issues surrounding anonymity and gamete donation are sure to be a centrally debated issues within the field of ART for the foreseeable future.

IVF cycles often result in couples transferring several embryos and cryopreserving other embryos produced by the cycle, presumptively for the purpose future pregnancy. However, in many instances, these surplus embryos are never used by the genetic parents and therefore are stored indefinitely [44]. The number of such embryos stored internationally is surprisingly high. In the United States alone, it is estimated that over 400,000 embryos are currently cryopreserved, many of which will not be used by their genetic parents [44]. The ethical and moral issues surrounding how to deal with these surplus embryos have been the source of much debate. In general, four possible fates for these embryos exist [44]:(1)thawing and discarding,(2)donating to research,(3)indefinite storage,(4)donating the embryos to another couple for the purposes of uterine transfer.

All of these strategies have staunch supporters and detractors. Not surprisingly, there are a myriad of laws in different countries governing many aspects of how a human embryo that has been cryopreserved may be handled [44, 45]. The use of embryos for the purpose of research, specifically as it relates to human stem cells, has also been a source of fierce debate internationally and has resulted in substantial regulation that varies substantially from nation to nation [4649].

Another topic of ethical, social, and legal debate surrounds the use of surrogacy and gestational carriers. Surrogacy is defined as a woman who agrees to carry a pregnancy using her own oocytes but the sperm of another couple and relinquish the child to this couple upon delivery [50]. A gestational carrier, by contrast, involves a couple who undergoes IVF with their genetic gametes and then places the resultant embryo in another womans uterus, the gestational carrier, who will carry the pregnancy and relinquish the child to this couple upon delivery [50]. Currently, the use of gestational carriers is far more common than that of surrogates [50].

As with donor gametes, surrogates and gestational carriers are subject to significant medical and emotional risks from carrying a pregnancy and undergoing a delivery [50]. As such, extensive counseling and meticulous informed consent are required [50]. Some also are concerned that the use of surrogates and gestational carriers is a form of child selling or the sale of parental rights [51]. Additionally, the rights of the surrogate or gestational carrier to not relinquish the infant following deliver are not well described [50]. In fact, legal precedent in some states within the United States has actually upheld the right of a birth mother, regardless of genetic relation to the child, to retain parental rights despite the existence of a preexisting gestational carrier contract [50].

Another central concern surrounding the use of surrogates and gestational carriers is the possibility that financial pressures could lead to exploitation and commoidification of the service [5053]. The mean compensation for a gestational carrier in the United State in 2008 was estimated at approximately $20,000 [50]. In contrast, a gestational carrier in India receives an average of $4,000 for the same service [52]. Regulation of surrogates and gestational carriers varies widely from nation to nation and even within regions of individual countries [50, 5256]. Due to these financial and legal considerations, international surrogacy has emerged as an emerging industry, especially in developing nations [52]. This practice has exacerbated the already difficult ethical and legal issues surrounding gestational carriers [52]. At the present time, issues surrounding issues of individual rights, commoidification, exploitation, citizenship of the offspring of international gestational carriers, and even fair trade are largely unresolved internationally [52, 55].

There are questions that remain outstanding regarding the use of IVF. Conflicting data exists about the risks of IVF on the developing embryo. Multiple studies have failed to find a clinically relevant association between IVF or embryo cryopreservation and adverse maternal or fetal effects [5759]. Other studies have suggested that infants of IVF pregnancies may be at a small but statistically significant increased risk for rare epigenetic and other abnormalities [6062].

Despite this controversy, there is a general consensus that IVF confers a small but measurable increased risk for a variety of congenital abnormalities including anatomic abnormalities and imprinting errors as compared to the general population [63]. Some maintain, however, that this is secondary to an increased baseline risk for these problems in the population of infertile patients [63]. Regardless of the cause, this small increased risk, while statistically significant with extremely large sample sizes, will likely not be a powerful enough factor to dissuade infertile couples from pursuing parenthood through IVF.

ART has emerged as one of the most widely adopted and successful medical technologies in the last century. While giving hope to millions of couples suffering from infertility, ART also has presented new ethical, legal, and social questions that society must address. Many countries have taken steps to regulate certain aspects of ART. Specifically, what regulations and laws should be in place for ART reporting, social inequities that may arise from financial barriers to ART, genetic testing, emerging laboratory techniques that have improved embryo and gamete survival when cryopreserved, and an individuals right to their genetic offspring in the setting of gamete or embryo donation are aspects of ART which will become increasingly controversial and debated into the future.

However, the lions share of ethical and legal questions that exist surrounding ART have yet to be resolved. Society must reconcile how to fund ART in a responsible and equitable manner to increase access to care. Additionally, the myriad of unresolved issues surrounding gamete and embryo donation must be addressed in greater detail in future social and legal dialogues.

ART is a field that is dynamic and ever changing. In areas of ART such as preimplantation genetics, new technologies continually change the capabilities of ART. Due to the rapidly evolving nature of the ART, legislation is often unable to keep pace and address all of the ethical and legal issues that are constantly emerging in the field. It is therefore incumbent upon physicians to continually monitor these issues and ensure that ART technologies are offered and delivered in a manner that balances patient care with social and moral responsibility.

The authors declare that there is no conflict of interests.

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The Ethical, Legal, and Social Issues Impacted by Modern ... - Hindawi

Closing Date: 19/12/2022Location: Manchester

An exciting opportunity has arisen at The Christie Pathology Partnership (CPP) for a Band 7 Clinical Cytogeneticist to join our Cytogenetics department. Clinical Cytogeneticist will work as part of a team to provide an effective and high-quality genomic analysis service to aid the diagnosis and treatment of patients with leukaemia and other cancers for Greater Manchester, the North West of England and other customers of the Christie Pathology Partnership. About us The Christie Pathology Partnership was formed in 2014 and is a joint venture between The Christie NHS Foundation Trust and SYNLAB, the largest provider of laboratory pathology and diagnostic services in Europe. We provide Pathology services for The Christie, the largest single site cancer centre in Europe, treating more than 44,000 patients a year and recently rated Outstanding by the CQC. SYNLAB is the European leader in delivery of high quality pathology testing and imaging services. SYNLAB operates in 35 countries across four continents, employing more than 20,000 members of staff and conducting approximately 500 million tests per annum. SYNLAB in the UK is a trusted expert in clinical laboratory services, drug and alcohol testing and food testing. We provide a wide range of testing capabilities and advanced pathology services through to the most innovative molecular and genetic diagnostic tests available today. The purpose of the role is to: To apply specialist scientific knowledge in cancer cytogenomics in the interpretation and reporting of, often complex, genetic information to clinicians and in producing interpretive reports for authorisation by a senior Clinical Cytogeneticist. To participate in laboratory and quality management processes to ensure the effective operation of the department and to maintain the service to standards expected by local policies, professional guidelines and UKAS accreditation, include writing and reviewing SOPs, participation in internal audit and external EQA. The post holder will participate on a rotational basis specific duties covering; duty scientist role including effective specimen handling, interpretation of referral reasons, deciding test and culture regimes, allocation of duties and dealing with telephone enquiries; managing FISH workflow on both liquid and FFPE preparations. The postholder will supervise and provide scientific support to technical staff. The role will involve contributing to the diagnostic workload for G-band chromosome analysis of blood and bone marrow preparations. To participate in SNP array analysis and interpretation, as part of a new service currently in development in the department. The post holder will have specific designated departmental responsibilities, appropriate to the grade of post, allocated according to training and experience. These will be directed by the Service Managers and may be on a rotational basis. Develop personal knowledge of genomics for the benefit of the service and the wider scientific community. The successful candidate will ideally have: A minimum of second class BSc(Hons) in a relevant subject. State registration with Health and Care Professions Council as a Clinical Scientist. Post Graduate Certificate of Competence in Clinical Cytogenetics or equivalent. Formal training as a Clinical Scientist in diagnostic Clinical Cytogenetics including work with chromosome analysis and FISH. High level working knowledge of Cytogenetic techniques including fine laboratory work, sterile culture work, sample preparation and microscopy requiring manual dexterity. Highly skilled in cytogenomic analysis techniques, such as G-banded chromosome analysis, FISH analysis and SNP arrays. We SYNLAB is a committed equal opportunities employer and we are open to flexible working. Once trained, the successful candidate may be expected to cover early evening and weekend sample receipt. We will accept applications from trainee scientists who are nearing registration. Applicants must currently have permission to work in the UK. For further information please email: asmaa.tanver@synlab.co.uk

Asmaa TanverEmail: asmaa.tanver@synlab.co.ukWebsite: https://synlab.co.uk/careers/opportunities/

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BSGM - The British Society for Genetic Medicine

Citizens Jury

In June 2017, we brought together a small, diverse group of citizens to address the question: Would research access to the Guthrie Card heel prick blood tests be in the public interest, and, if so, under what conditions? A Citizens Jury is a well-established method to enable public participation in policy making, allowing informed deliberation on an issue and the provision of recommendations. Our Citizens Jury followed best practice for such deliberative public engagement3. First, we convened a steering group to provide oversight of the materials prepared for the Jurors and to identify a range of expert witnesses to give evidence. Next, we consulted a Patient Participatory Involvement and Engagement (PPIE) panel to review these materials. The academic researchers did not involve themselves directly in the Jury process, other than to provide evidence or observe. The recruitment, facilitation and analysis were conducted by Ipsos MORI, Scotland, to preserve neutrality. Jurors met together for two day-long sittings to hear evidence (neutral, for and against), deliberate and reach conclusions.

Using a quota sample, a representative pool of the adult public was recruited in terms of sex, age, working status and social grade. Additional quotas were set to ensure sufficient representation of people with children under the age of five, and people with a family history of a medical condition. An attitudinal quota was set to ensure inclusion of people with varied levels of trust in public, private and third sector organisations, as previous research has found this to be a significant factor underpinning views of data sharing and use4. A total of 20 were recruited of whom 19 participated on day one, and 18 returned for the second day a week later. Jurors were given monetary recompense for taking part in each sitting.

Day One started with a warmup session sharing their views on health research and health-relevant information, followed by evidence from various experts to stimulate discussion of issues around research use of the newborn blood spots. Day Two included further expert witnesses but more time for Jurors own deliberations and to arrive at a conclusion on the key question. Facilitation tools, such as speed dating techniques, meant that all Jurors could express and reflect on their own views as well as those of others, building up to group and plenary deliberations. The first day focused on more general discussion and information sharing; the second day involved detailed deliberation of the key question and delivering of the verdict. Both days were audio recorded and transcribed for subsequent analysis. A short questionnaire was administered at the end of each day to gauge individual level views and thinking.

Background information was provided by authors SCB and DJP during the morning of Day One. Over the 2 days, six witnesses were called to give evidence and answer Jurors questions. These comprised health care professionals and scientists, a Caldicott Guardian (a person responsible for protecting the confidentiality of peoples health and care information and making sure it is used properly) and a Genewatch spokesperson (representing not-for-profit groups that monitor developments in DNA technologies). Jurors also had access to a short video and other written information about comparative deliberations and policy in California and Denmark. Having heard on Day One some of the health research opportunities uniquely possible if access were granted, an introduction to some of the social, ethical and legal issues, and how the NHS protects privacy, Jurors heard more opposing and critical views on Day Two, with one witness cautioning against allowing research access and another the importance of not compromising the newborn screening programme itself.

The Scottish newborn blood spots archive is stored in around 900 boxes each containing circa 3000 cards in a single secure location under the authority of the Director of the Scottish Newborn Screening laboratory and custodianship of the NHS Research Scotland Greater Glasgow and Clyde Biorepository. A unified digital record is in place from 2000 onwards, but the content and consistency of information available from older cards was not known at the outset. The design and information content of the newborn blood spots was known to have varied over time, but not documented. We were aware that some cards had suffered water damage prior to assembling the nation-wide archive. We also know that for a period of time some cards had been autoclaved before storage. For the vast majority, the newborn blood spots have simply been stored at room temperature. The unified newborn blood spot archive management database has limited, high-level summary information on the contents of each box.

We obtained permission from the Caldicott Guardians of NHS Research Scotland Greater Glasgow and Clyde and of Tayside to retrieve representative boxes from the NHS Research Scotland secure archive. Permission was given for (a) examination and documentation of a sub-sample from each box to provide a snap-shot of the information attached that might be required from the purposes of linkage to other routine health records and (b) sampling of cards corresponding to consented members of Generation Scotland.

Thirty boxes representing each decade from 1965 to 1999 were retrieved and examined by NHS Scotland staff at the NHS Research Scotland Greater Glasgow and Clyde Biorepository. Only summary information was shared with the rest of the study team.

The organisation and information content by box varied over time (Supplementary Fig.1). In some boxes there were unlabelled bundles of cards (Supplementary Fig.1D), but most had 4 labelled foolscap sub-boxes (Supplementary Fig.1B) with multiple, date-labelled bundles of cards (Supplementary Fig.1C).

We drew up a list of potential information that the newborn blood spots might carry from which to judge the feasibility of conducting epidemiological studies by linkage to NHS Scotland routine medical record and potentially additional consented data from research subjects.

For each box, we collected the following information: Box ID; Area Health board; Hospital; Type of card; Date of test; Child forename; Child surname; presence or absence of Community Health Index identifier. No personal information was recorded. Each box took 2 members of staff working in tandem ~2h to document.

Next, circa 1 in 100 cards from each box were examined in detail and the presence or absence of the following features documented: Child DOB; Additional comments on card; Number of blood spots; Size of spots; Mothers CHI; Mothers forename, surname and birth name; Mothers date of birth; Address; Postcode; Whether the cards had been autoclaved prior to archiving; Any other comments.

Cards from 1965 had very little information on them and in many cases did not even record the sex of the baby. Information content increased progressively over time. By the 1990s, the sex of the child and home address were generally recorded.

Over 24,000 Generation Scotland (GS) volunteers were recruited as adults between 2006 and 20115. All were born before 1993, before the digital recording of newborn blood spots began. Consent for linkage to medical records was optional but was given by 98% of volunteers. They were asked to give information about their place of birth (country and council area). A total of 8703 volunteers with linkage consent were born in Glasgow or Tayside area health boards between 1965 and 1992. The set of 30 boxes retrieved and documented for epidemiological purposes were selected on the basis that (a) Greater Glasgow and Tayside were the regions for which we had Caldicott Guardian approval and (b) they were expected to include bundles from Generation Scotland participants as the majority came for these regions. A list of names, birthplace and date of birth was extracted from the GS database and sent to the NHS Greater Glasgow and Clyde Biorepository to look for matching cards. Pseudonymous ids were added to the list so that any samples from matching cards could be labelled and linked back to the GS database after genotyping. Ninety-two matching cards were identified amongst newborn blood spots from Tayside. Of these, 58 were usable for punching having fulfilled the prerequisite of leaving one spot intact (Supplementary Fig.2). Six to ten punches were taken from each card, placed in vials labelled with a pseudonymous ID for matching to the samples donated at baseline by each Generation Scotland volunteer, and couriered to the Edinburgh Clinical Research Laboratory Genetics Laboratory for DNA analysis.

Unlike the Danish Newborn Screening Biobank (DNSB), the Scottish newborn blood spot archive comprises a variety of paper types and storage conditions, particularly for older cards. To establish the effect this might have on the recovery of analysable DNA, a pilot study in 20122014 was undertaken on a de-identified set of 136 newborn blood spots dated from 1965 to 2012 (Table1). The study was mandated by the Scottish Chief Scientist Office, following a favourable opinion from the Scottish Legal Office and North of Scotland Research Ethics Committee. De-identified cards were provided by the Scottish National Dried blood spot collection, Biochemical Genetics Laboratory, Duncan Guthrie Institute, Greater Glasgow Health Authority, Yorkhill, Glasgow. DNA was extracted from 3mm punches using the Sigma ENA kit. Yields varied from sample to sample, but there was no significant effect of date of birth and sufficient material was obtained for Sanger DNA or exome sequencing in 94% of samples (Table1). Exome sequencing used the Ion AmpliSeq exome kit run on IonTorrent Proton sequencer. Data analysis and variant calling used the IonReporter IonExpress variant caller, 4245 million mapped reads, 94.294.7% on target, mean depth 122130 reads per sample. Thirty one of 32 runs met standard QC criteria for variant analysis.

Of the 92 newborn blood spots matched to GS volunteers, 58 (63%) had sufficient dried blood spot material remaining to take 3mm diameter punch samples, while leaving at least one spot intact. These 58 were from Generation Scotland research volunteers born between 1983 and 1989 (i.e. 3238 years between collection and profiling). DNA was extracted from between 6 to 8 blood spot punches using the QIAamp DNA Investigator Kit (Qiagen; cat. no. 56504), following the manufacturers instructions. The concentration of the DNA samples was measured using a Qubit 2.0 fluorometer and the Qubit dsDNA HS assay (Thermo Fisher; cat. no. Q32854). Total yield isolated was between 196 and 1177ng of DNA. Up to 500ng DNA (range 160500ng) underwent bisulfite conversion (Zymo EZ-96). DNA methylation was profiled using the Infinium HumanMethylationEPIC v1.0 BeadChip (Illumina Inc.; cat. no. WG-317-1001), according to the manufacturers protocol (in batches of 8 samples, 56 assayed of the 58 samples processed). Arrays were scanned on an iScan and analysed using GenomeStudio v2011.1.

DNAm profiles were obtained from the 56 individuals using the Illumina MethylationEPIC beadchip, measuring ~850,000 CpGs across the genome. Quality control measures were performed, removing probes with high detection p-values (>0.05) in >5% of samples (N=52,375), or a beadcount <3 in more than 5% of samples (N=5038). Three samples were removed for having >5% of sites with a detection p-value >0.05. In addition to these standard quality control measures, additional checks were performed to ensure newborn blood spots and baseline samples matched with regard to predicted sex and genotype (Supplementary Information Methods, Supplementary Figs.3 and 4 and Supplementary Table1). Quality control and analysis code have been deposited in a public repository6. To access Generation Scotland data, including the data derived in the feasibility study described here, please go to http://www.ed.ac.uk/generation-scotland/for-researchers/access.

Confirmatory analyses were performed using newborn blood spots DNA methylation data to ensure predicted sex (using X-chromosome data) and genotype (using rs control probes on the EPIC array) were consistent with peripheral blood-based genotyping and DNA methylation data on samples collected at baseline recruitment (20062011) (Supplementary Table1). Detailed information on sample checks is presented inSupplementary Information Methods and Supplementary Figs.3 and 4.

An individuals smoking status can be reliably predicted using composite DNA methylation-derived smoking scores, and effects have also been observed in the offspring of mothers who smoked during pregnancy7. Moreover, information from a single probe in the aryl-hydrocarbon receptor repressor gene (AHRR; cg05575921) can serve as a robust marker of smoking, with lower DNA methylation levels associating with current smoker status. Maternal smoking status at the time of sample collection was derived from smoking status at GS baseline, and the years stopped variable for former smokers, where both mother and baby are in GS. DNA methylation-based estimates of smoking status were obtained, using previously validated methods8. A composite score for smoking status (EpiSmokEr) was obtained using Guthrie sample DNAm data and, along with cg05575921 DNA methylation levels, was plotted against maternal smoking status at the time of sampling (Fig.1). Consistent with previous literature, a higher overall value was observed for the EpiSmokEr score in the offspring of current smokers whereas a lower overall value was observed for the offspring of never smokers, supporting an association at the population level (Fig.1a; ever smoker =0.78; sex-adjusted linear regression P=0.026). DNA methylation levels at cg05575921 were also consistent with the literature, with lower overall levels in the offspring of current smokers relative to never smokers (Fig.1b; ever smoker =0.72; sex-adjusted linear regression P=0.05).

Methylation-derived smoking scores from newborn blood spot DNA (y-axis) plotted against maternal smoking status (current, former, never) at time of birth (NCurrentSmokers=10; NFormerSmokers=5; NNeverSmokers=26). Results are shown for the EpiSmokEr score, a composite measure comprised of multiple CpG sites (a), and DNA methylation levels at a single CpG (cg05575921) in the AHRR gene (b). Upper and lower hinges correspond to the upper and lower quartiles, respectively. Whiskers extend to data points as far as 1.5 times the interquartile range. Outlying data points are defined as those beyond the whiskers. Thick horizontal lines represent the median.

The original Sanger DNA and exome sequencing study was mandated by the Scottish Chief Scientist Office, following a favourable opinion from the Scottish Legal Office and the North of Scotland Research Ethics Committee, REC ref. 11/ns.0014. A letter approving the inspection and documentation of newborn blood spots and selective sampling of GS cards for methylation analysis was provided by the Chief Medical Officer for Scotland on 4 September, 2019. The Caldicott Guardians of NHS Greater Glasgow and Clyde and NHS Tayside granted approval on 30 January 2020 and 3 March 2020, respectively. Volunteers for Generation Scotland gave informed consent at the time of recruitment for biological studies, including genetic studies, on their biological samples and for linkage to medical records. A substantial amendment to the Research Tissue Bank approval for Generation Scotland to cover the feasibility study was submitted to the East of Scotland Research Ethics Committee and approved on 13 March 2020.

The Citizens Jury followed INVOLVE guidelines and was conducted by the polling organisation, Ipsos MORI, on behalf of the University of Edinburgh research team. This work was carried out in accordance with the requirements of the international quality standard for Market Research, ISO 20252:2012, and with the Ipsos MORI Terms and Conditions which can be found at http://www.ipsos-mori.com/terms. Ipsos MORI conducted their own internal ethical review through their ethical review team. The Ipsos MORI Project Director (CM) was then responsible for ensuring that the research materials (recruitment screener, participant information sheets, discussion guides) were clear and met the ethics principles on informed consent, right to refuse, principles of anonymity and confidentiality. No sensitive information was collected. Materials were saved in a secure folder with access restricted to the Ipsos MORI team (CM, SD). After completion, all personal information (participant names, contacts details, recordings and transcripts) were securely destroyed using Ipsos MORI digital shredding software.

Further information on research design is available in theNature Research Reporting Summary linked to this article.

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Feasibility and ethics of using data from the Scottish newborn blood spot archive for research | Communications Medicine - Nature.com

There is not a single, universal blueprint for closing down a health care practice. Requirements often differ slightly based on state law and circumstance. That said, in order to make the process go smoothly to minimize any potential risk or liability, there are some general guidelines that health care providers should be aware of prior to closing down a practice.

Notification

There are several parties that a practice may be required to notify prior to its closing. These parties include, but are not limited to: patients, federal and state agencies and licensing boards, employees, payors, vendors, and other business associates. Each party has unique notification requirements, subject to relevant law and custom.

Notification to Patients

Notification to patients normally must occur between one and three months prior to the closing date to avoid claims of abandonment. Notification should be given to all active patients, which depending on your state, can be any patient the physician has treated sometime in the past 12-36 months. The timing and method of notification can differ based on the health status of the patient. For example, high risk patients may need the notice to be sent via certified mail so the practice can track whether it was received or, if undeliverable, the practice can record that an attempt was made to reach the patient in an effort to minimize risk of any claim to the contrary.

In each case, the notice to patients will need to include certain information. This information will likely include the date of closing, the name(s) of local physicians that would be willing to accept new patients, the name of the physician(s) taking over the practice (if applicable), instructions for how to obtain or transfer medical records and a deadline for submitting record requests, new contact information for the departing physician, a way to contact the practice regarding any questions or concerns patients and their families may have in regards to the practice closing, and information regarding where the medical records will be stored after the practice closing. Providing thorough and accurate notice to patients will help address any confusions patients or their families may have, and hopefully reduce any complications going forward.

Some states, such as Illinois, require the notice to be published as an advertisement in the local newspaper. States that have this requirement will specify the period of time prior to closing the advertisement needs to be published and how long the advertisement will need to run. Notification also should be posted throughout the practice, and patients who call or visit should be given verbal reminders.

Notification to Employees

It is important to notify practice employees. It is best that employees hear about the closing from the practice directly and that they are notified early in the process. Practices can incentivize employees to stay until the practice is officially closed, but should be prepared to hire temporary help should employees decide to leave prior to the closing date.

Notification to Entities

When closing a practice, certain federal, state and local agencies and organizations may need to be notified. Each entity will have different requirements, so it is important to be familiar with these requirements or consult with a local expert. For example, notification to the Federal Drug Enforcement Agency (DEA) must be in writing and specify whether you wish to continue or surrender the DEA registration. Also, providers are required to notify the Centers for Medicare & Medicaid Services no later than 90 days after a decision to retire or withdraw from the Medicare program.

Notification also should be made to the practices malpractice insurance carrier and any other insurance carriers that contract with the practice (for example, workers compensation policy or as part of any employee benefit plans). If the practice is affiliated with any hospitals, referring physicians, state and local medical societies, insurers or managed care companies, they also should be given notice.

As with any winding up of a business, it is important to review contracts to which the practice is a party. Contracts, for cleaning services, waste disposal, internet, laboratory services, and the like may require notice in writing of termination and could have penalties for early termination. The same goes for termination or assignment of any lease agreements. If the practice owns the space where it is located, it will need to determine if the space will be sold or leased to a new business.

Record Retention

While the medical record itself generally is understood to be the property of the practice, the information contained in the record is the property of the patient. As such, the practice should obtain HIPAA-compliant authorizations to transfer records at the patients request. Where records are not transferred, they will need to be stored by the practice for a period of time. Some states have specific record retention requirements. Indiana, for example, requires that all records must be retained and kept confidential by the practitioner for at least seven years.

If your state does not have a required period of retention, a good general rule is to arrange to store adult medical records for seven to ten years. For minors, good practice is to retain medical records until they reach the age of 21 years and the length of time the practice retains adult records has gone by since the last treatment date.Medicare and Medicaid records should be retained in their original form for at least ten years.In any case, it is important that records be available for the period prescribed by your states malpractice statute of limitations.

In some states, a state archive or health department will store health records from closed facilities. However, it is more common that records are transferred to another healthcare provider or stored physically in a HIPAA-compliant storage facility or electronical repository. Whether records are held in a storage facility or transferred to another healthcare provider, it is important to notify patients of the storage location and instruct them as to how to obtain records after the practice has closed. Any records that can legally be destroyed should be shredded or otherwise destroyed in a HIPAA-compliant fashion.

Insurance

Closing a practice does not exempt it from liability for anything that may have occurred while the practice was active. The practice will need to ensure that both it and its providers are covered by liability insurance through a tail policy or some other form of continuing coverage. If a provider is retiring and has been with his or her malpractice carrier for a certain period of time, it may be possible to obtain tail coverage for little or no cost.

Additional Considerations

Make sure to collect accounts receivable. The practice may need to arrange for another physician to collect remaining accounts or turn past due accounts over to a collection or billing agency.

Be sure to repay all debts and liabilities and pay malpractice premiums. Once all liabilities have been paid, practice owners will need to determine how to distribute any remaining income. It is recommended that the practice retain some funds for a period of time to cover the cost of surprise or otherwise unknown liabilities that may present at a later date.

It is recommended that the practice consult with legal counsel to complete certain legal documents to properly dissolve the practice entity with the state of formation. Further, the practice should consult with its accountant to make sure any tax-related issues are addressed.

Conclusion

Closing a medical practice may seem like a challenging task. While there are a number of components to consider, it does not need to be an overwhelming experience. By keeping these guidelines in mind, and consulting the necessary experts, a practice can create and execute a plan that allows for a seamless transition and minimizes future legal implications.

Christina M. Kuta, J.D., LL.M., M.S.W., is of counsel in the Health Law group atRoetzel& Andress in Chicago. She can be reached atckuta@ralaw.com.

Delaney Perl, J.D., is an associate in the Health Law group atRoetzel& Andress in Chicago.

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Closing your health care practice: What you need to know - Medical Economics

Survey shows that alternative sites for care are gaining popularity with consumers

When it comes to where Americans prefer to receive their care, retail clinics, virtual health, and community centers are all growing in popularity, according to a survey from the Deloitte Center for Health Solutions. These changes reflect patient preferences to have health care be more similar to other consumer retail experiences.

There is a growing desire to use retail clinics, and this is especially true among underserved populations, according to the survey. Only 10% of consumers have used a retail clinic in the past year, but many more say the would be likely to or maybe would use retail clinics for preventive care (55%) or mental health care (47%). Black, Asian, and Hispanic respondents were more likely than White respondents to use retail clinics, and urban respondents were more likely than rural ones.

Virtual care, which became popular during the worst months of the pandemic, continues to be popular with patients. Nearly three in four consumers with Medicaid (74%) or HIX plans (73%) would use virtual health for mental health visits, and nearly two-thirds of all consumers would use virtual visits for preventive care.

According to the report, health care organizations looking to stay relevant need to take several steps. They should create more access points and include opportunities to address the drivers of health. They need to develop diverse care teams, ensure care continuity, and invest in virtual health technology and training.

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Is the doctor's office heading for extinction? - Medical Economics

On June 24, 2022, the Supreme Court of the United States overturned Roe v. Wade, the landmark 1973 decision that established a constitutional right to abortion across the country.

As a result of the ruling, individual states have the ability to set their own abortion laws.

Now some states have passed laws to restrict abortion to certain points in pregnancy or virtually ban it nearly altogether.

Some of those restrictions have been temporarily blocked due to court challenges.

Voters in some states will also have the opportunity to vote on abortion-related ballot measures in the upcoming midterm elections.

This round-up provides an overview of the current legal status of abortion in all 50 states and Washington, D.C. The information in this article was accurate and up to date at the time of publication, but its possible that some information has since changed.

To learn about your legal rights, consider contacting the Repro Legal Helpline through a secure online form or by calling 844-868-2812.

Here are some common terms that you might come across while learning about abortion laws:

In Connecticut, abortion is legal and unrestricted until a pregnancy reaches viability. After viability, abortion is only legal if your physical or mental health or life is in danger.

Additional restrictions:

In Delaware, abortion is legal until a pregnancy reaches viability. After that, abortion is only legal if:

Additional restrictions:

In Maine, abortion is legal and unrestricted until a pregnancy reaches viability. After that, abortion is only legal if your physical or mental health or life is in danger.

Additional restrictions:

In Massachusetts, abortion is legal before 24 weeks of pregnancy. From week 24 onwards, its only legal if:

Additional restrictions:

In Maryland, abortion is legal until a pregnancy reaches viability. After viability, abortion is only legal if:

Additional restrictions:

In New Hampshire, abortion is legal before 24 weeks of pregnancy. From 24 weeks onwards, its only legal if:

Additional restrictions:

Abortion is legal and unrestricted in New Jersey.

Additional restrictions:

In New York, abortion is legal and unrestricted until a pregnancy reaches viability. After that, abortion is only legal if your physical or mental health or your life is in danger or if the fetus will not survive.

Additional restrictions:

In Pennsylvania, abortion is legal before 24 weeks of pregnancy. From week 24 onwards, its only legal if your physical health is at serious risk or your life is in danger.

Additional restrictions:

In Rhode Island, abortion is legal until a pregnancy reaches viability. After viability, abortion is only legal if its necessary to save your life.

Additional restrictions:

Abortion is currently legal and unrestricted in Vermont. You can legally get an abortion at any stage of pregnancy.

Voters in Vermonts midterm elections will have the opportunity to vote on a constitutional amendment to protect the right to abortion in the state.

Additional restrictions:

Abortion is currently legal and unrestricted in Washington, DC. You can legally get an abortion at any stage of pregnancy.

Additional restrictions:

In Alabama, abortion is banned with very limited exceptions. Its only legal if its necessary to prevent serious risks to your physical health or save your life. Theres no exception for rape or incest.

In Arkansas, abortion is banned with very limited exceptions. Its only legal if its necessary to save your life. Theres no exception for rape or incest.

In Florida, abortion is legal until 15 weeks of pregnancy. After that, its only legal if:

Theres no exception for rape or incest.

Abortion providers are suing to block the ban on abortion after 15 weeks.

Additional restrictions:

In Georgia, abortion is legal until a so-called fetal heartbeat is detected, around 6 weeks of pregnancy.

At six weeks of pregnancy, embryos dont have hearts just cells that emit an electrical charge, which can be detected on an ultrasound.

After that, abortion is only legal if:

Additional restrictions:

In Louisiana, abortion is banned with very limited exceptions. Its only legal if:

Theres no exception for rape or incest.

In Mississippi, abortion is banned with very limited exceptions. Its only legal if:

In August 2022, a US district court judge in North Carolina allowed a 2019 abortion law to go into effect. Under this law, abortion is legal up to 20 weeks of pregnancy. After that, its only legal if your health or life is in danger.

Additional restrictions:

In June 2022, South Carolina passed a law to ban abortion after a so-called fetal heartbeat is detected, which typically happens around 6 weeks of pregnancy.

At six weeks of pregnancy, embryos dont have hearts just cells that emit an electrical charge, which can be detected on an ultrasound.

However, the South Carolina Supreme Court has temporarily blocked that law.

While that law is blocked, abortion is legal before 22 weeks of pregnancy. From 22 weeks onwards, its only legal if:

Additional restrictions:

In Tennessee, abortion is banned with very limited exceptions. Its only legal if:

Theres no exception for rape or incest.

In Kentucky, abortion is currently banned with very limited exceptions. Abortion is only legal if its necessary to prevent serious risks to your physical health or save your life. Theres no exception for rape or incest.

In Novembers midterm elections, Kentucky voters will be asked to vote on a ballot measure to establish that the state constitution does not recognize or protect a right to abortion.

In Virginia, abortion is legal before 27 weeks of pregnancy. From week 27 onwards, its only legal if your physical or mental health or your life is in danger.

Additional restrictions:

As of September 16, 2022, abortion is banned with very limited exceptions in West Virginia.

Its only legal if:

In Illinois, abortion is legal until a pregnancy reaches viability. After viability, abortion is only legal if your health or life is in danger.

In August 2022, Indiana legislators passed a law to ban nearly all abortions. It was scheduled to come into effect in September. However, its currently being challenged in court and has been temporarily blocked.

While that law is blocked, abortion is legal before 22 weeks of pregnancy. From week 22 onwards, its only legal if your physical health or life is in danger.

Additional restrictions:

Currently, abortion is legal before 22 weeks of pregnancy in Iowa. From 22 weeks onwards, its only legal if your physical health or life is in danger.

In 2018, Gov. Kim Reynolds (R) signed a more restrictive law that would only allow abortion until a so-called fetal heartbeat is detected, around 6 weeks of pregnancy. A Polk County district court blocked that law from coming into effect. Now, Gov. Reynolds is asking the court to reinstate the law.

At six weeks of pregnancy, embryos dont have hearts just cells that emit an electrical charge, which can be detected on an ultrasound.

Additional restrictions:

In August 2022, Kansas voters rejected a ballot measure that would have removed abortion protections from the state constitution.

In Kansas, abortion is legal before 22 weeks of pregnancy. From 22 weeks onwards, its only legal if your physical health or life is in danger.

Additional restrictions:

Abortion is currently legal in Michigan until a pregnancy reaches viability. After viability, its only legal if its necessary to save your life.

Voters in Michigans midterm elections will have the chance to vote on an amendment to protect the right to abortion in the states constitution.

Additional restrictions:

In Minnesota, abortion is legal until a pregnancy reaches viability. After viability, its only legal if your physical or mental health or your life is in danger.

Additional restrictions:

In Missouri, abortion is banned with very limited exceptions. Its only legal if your physical health is at serious risk or if its necessary to save your life. Theres no exception for rape or incest.

In Nebraska, abortion is legal before 22 weeks of pregnancy. From 22 weeks onwards, its only legal if your physical health or life is in danger.

Additional restrictions:

Before Roe v. Wade was overturned, North Dakota passed a trigger law that would ban nearly all abortions. However, after an abortion provider filed suit to challenge the ban, a judge temporarily blocked it before it could come into effect.

While that law is blocked, abortion is legal before 22 weeks of pregnancy. From week 22 onwards, its only legal if your physical health or life is in danger.

Additional restrictions:

In June 2022, Ohio passed a law to ban abortion after a so-called fetal heartbeat is detected, which typically happens around 6 weeks of pregnancy. However, that fetal heartbeat law has been temporarily blocked and is currently being challenged in court.

At six weeks of pregnancy, embryos dont have hearts just cells that emit an electrical charge, which can be detected on an ultrasound.

While that law is blocked, abortion is legal before 22 weeks of pregnancy. From 22 weeks onwards, its only legal if your physical health or life is in danger.

Additional restrictions:

In South Dakota, abortion is banned with very limited exceptions. Its only legal if your physical health is at serious risk or its necessary to save your life. Theres no exception for rape or incest.

When Roe. v. Wade was overturned, a long-dormant 1849 Wisconsin law came into effect. Under this law, abortion is only legal if your health or life is in danger. Theres no exception for rape or incest.

Attorney General Josh Kaul (D) is currently suing public officials to block the enforcement of this law. If hes successful, abortion will be legal before 22 weeks of pregnancy. From 22 weeks onwards, it will only be legal if its necessary to prevent serious risk to your physical health or save your life.

On September 23, 2022, a state judge reinstated a law from 1864 that bans abortion with very limited exceptions. As a result, abortion is only legal in this state if its necessary to save your life. Theres no exception for rape or incest.

Before this ruling, state legislators had passed a law that would allow abortion up to 15 weeks of pregnancy.

Abortion is legal and unrestricted in New Mexico. You can legally get an abortion at any stage of pregnancy.

Additional restrictions:

In Oklahoma, abortion is banned with very limited exceptions. Its only legal if its necessary to save your life. Theres no exception for rape or incest.

In Texas, abortion is banned with very limited exceptions. Its only legal if its necessary to prevent serious risk to your physical health or save your life. Theres no exception for rape or incest.

In Alaska, abortion is legal at any stage in pregnancy.

Additional restrictions:

In Novembers midterm elections, Californians will be invited to vote on an amendment to enshrine the right to abortion in the states constitution.

Abortion is currently legal and unrestricted until a pregnancy reaches viability. After viability, abortion is only legal if your health or life is in danger.

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Abortion Access in the U.S.: What to Know on a State-By-State Level - Healthline

Leila Ladaniis on a mission to cultivate a human-centered mindset to guide the design and manufacturing of biomedical devices and implants.

Ladani, a professor in theSchool for Engineering of Matter, Transport and Energy, part of theIra A. Fulton Schools of Engineeringat Arizona State University, is among pioneering biomedical engineers advancing the understandings of how devices can be used more effectively in clinical settings. ASU Professor Leila Ladani (left) works with student Carol Lu (right) in her research lab to develop a biomedical device to determine the presence of cancer in tissue margins during a lumpectomy, which will streamline the cancer removal process and reduce the need for re-excision. Photo courtesy Leila Ladani Download Full Image

Ladani was recently awarded a$3 million grantfrom theNational Science Foundation Research Traineeship Program to develop a new biomedical device manufacturing training program at ASU. Her project, Design and Manufacturing of Medical Devices and Implants: Cultivating a Human-Centered Mindset, will connect engineering students with health care professionals and patients to introduce them to the ethical principles, laws and policies associated with the development and use of biomedical technologies.

We want to put the users right at the forefront of innovation because the users are patients or clinicians, Ladani says. We want to make sure that what we are designing and manufacturing is something that they can actually use, with the mindset that human society is very complex.

Ladani was also recently nominated by ASU Provost Nancy Gonzales to participate in the ELATES leadership development program at Drexel University. The program is designed to support senior female faculty members and allies of all genders in STEM-related fields to hone their leadership effectiveness. Ladani was one of only 30 people to be selected for this years nationwide cohort. Over the course of the yearlong fellowship program, she will attend multiple in-person and online meetings with peers as each attendee develops an institutional action plan to advance a mission of their choosing.

During the process of developing her own biomedical device, Ladani discovered a knowledge gap between biomedical engineers and the communities they serve.

In collaboration withMayo Clinicand one of its well-known surgical oncologists,Dr. Barbara Pockaj, Ladani is developing a device to determine the presence of cancer in tissue margins during a lumpectomy the surgical removal of a portion, or lump, of breast tissue, typically as a treatment for a malignant tumor or breast cancer.

ASU Women and Philanthropyis funding the development of the device, which will streamline the cancer removal process and reduce the need for re-excision.

With the intention of using the device in the operating room during surgery, Ladani realized the complexity of the clinical setting may not allow her current design to be used efficiently.

We needed to make sure the device could detect the location of the cancer accurately and make it easy for the doctors to be able to read the results while they were operating. I figured out that theres a big gap in theory and practice, Ladani says. We develop these innovations in the lab, but we dont really know what makes a device effective unless we have a close connection with the medical side.

Motivated to improve the experience of innovators who might encounter similar situations, Ladani began developing a program that would introduce STEM students to the nuances of device manufacturing. Program team members include faculty at ASU, includingKatina Michael,Jafar Razmi,Kaushal Rege,Karen Anderson,Jean AndinoandRick Hall, as well as Dr. Steven J. Lester, a cardiologist, professor of medicine, and founder and chief medical officer of theMayo Clinic-Arizona State University MedTech Accelerator.

The teams new biomedical device manufacturing program is built on a set of multidisciplinary and convergent research areas, which also builds on the strong relationship between ASU and Mayo Clinic and theMayo Clinic and Arizona State University Alliance for Health Care.

This endeavor represents an important facet in ASUs quest for excellence in which achieving a convergence of disciplines is a key imperative,ASU President Michael Crowsaid in support of the program.

Dr. Rafael Fonseca, chief innovation officer at Mayo Clinic, also strongly supports Ladanis project.

Training engineers who understand the practical limitations of their discoveries and inventions is critical in advancing solution-oriented discoveries, Fonseca says.

To effectively engage students in STEM with the medical aspects of their disciplines, they will connect with Mayo Clinic providers and key collaborators who are interested in the students prospective biomedical technologies or devices to shadow them for a semester.

This process helps create a foundation for truly use-inspired technology development, Lester says. The program is a wonderful example of the collaboration between Mayo Clinic and ASU, which work together to create an intellectual ecosystem with expertise from every area of health care.

Through the programs curricular components, including applied and experiential learning and entrepreneurial activities, students will develop their ideas for biomedical devices. Then, under the guidance of experts, students go through the processes of disclosure and filing patents, involving all the steps necessary to commercialize their innovative products.

The goal is to help students develop a sustainable, scalable product, taking into consideration legal, regulatory, compliance and reimbursement issues. The entrepreneurial focus opens the possibility for some of the students ideas, leading them to establish their own medical device companies.

The program also provides support for doctoral students through stipend and tuition coverage.

As a part of the project, Ladani is creating a new structured mentorship program for students at all levels. The Graduate-Undergraduate Mentorship program will give graduate students opportunities to spend a summer mentoring undergraduate students interested in developing their own devices.

Ladani and her team are also developing new courses to acquaint students with the ethical and regulatory aspects associated with medical devices and implants. The program will also include components like seminars, orientations, retreats and presentations from guest speakers in industry and academia.

Though doctoral students will spend only two years in the program, the community they build during their time as participants is intended to last a lifetime.

These students will have a breadth of understanding in several different areas that will impact their design work, Ladani says. With the information they gain, they will be more equipped to start their own companies to create devices as well as jobs.

The program will enable students to design next-generation medical technologies that enhance care delivery and patient outcomes.

Doctoral students from all engineering disciplines are encouraged to apply via an online portal set to launch in spring of 2023. Interested students can contact Ladani atladani@asu.edu.

Link:
Students can create their own path with new ASU Online biology degree - ASU News Now

Dr. Lance Eliot, an expert on AI & Law currently serving as a Stanford Fellow, argues that while the new US AI Bill of Rights is not a game changer, it is a step in the right direction...

What rights should we have in a society increasingly being scrutinized, monitored, and controlled via the use of Artificial Intelligence (AI)?

Thats a good question.

To address this thorny and unresolved legal issue, the US White House released on October 4, 2022, a white paper informally referred to as anAI Bill of Rights, which more officially is entitled Blueprint for an AI Bill of Rights: Making Automated Systems Work for the American People. The document is the work of the Office of Science and Technology Policy (OSTP), a federal entity that was established in the mid-1970s and serves to advise the American President and the US Executive Office on various technological, scientific, and engineering aspects of national importance.

Lets unpack the AI Bill of Rights and examine the pros and cons of this latest pronouncement pertaining to AI and the law.

Rightfully Thinking About AI And Human Rights

The naming of this as an AI Bill of Rights is a bit askew since it might inadvertently suggest that these are rights associated with AI systems that are considered reaching sentience or otherwise nearing a point of legal personhood. Not so. To clarify, this 73-page long document is abouthuman rightsamid the ongoing onslaught of AI systems that are being deployed without sufficient attention to humankinds safety and well-being.

You might be aware that AI has been put into use by numerous private and public organizations and has ended up acting in a variety of discriminatory ways. Our civil rights and civil liberties are under attack by how AI is crafted and utilized. AI at times is ruinously undercutting data privacy. AI permeates all manner of social media and can wrongfully suppress the speech of those criticizing hate speech, ironically so. AI can be used to stalk someone across both electronic and physical worlds, endangering their personal safety.

On and on, the litany of AI endangerment goes.

A technical companion portion within the AI Bill of Rights describes dozens of real-world examples showcasing how AI is being improperly devised and fostering potential harm. The examples suffice to get the hair standing on the back of your neck. As an additional harbinger of concern, keep in mind that AI is expansively being rolled out and will ultimately be ubiquitous. You can anticipate a non-stop barrage of AI amidst nearly all of our daily apps on our smartphones and likewise AI-powered applications used by major companies and by governmental agencies.

If we are inexorably going to be immersed in an AI-permeated way of existence, the logical response is to stand up for the rights of humankind. Thus, the reasoned basis to forge an AI Bill of Rights that can valiantly protect people.

The US Constitution famously has a historic Bill of Rights that includes vital guarantees of personal freedoms and mindfully addresses the codification of legally stipulated rights. The first ten amendments of the Constitution are breathtaking in their scope and significance. This AI Bill of Rights attempts to leverage the revered nature of the Bill of Rights to draw public attention to what needs to be considered in an AI era (some might readily criticize trying to somewhat exploit the famed Bill of Rights in this naming manner, perhaps overstepping a proper sense of decorum, though it could be a small price to pay for engaging society in the upcoming AI legal morass).

The AI Bill of Rights posits five keystones (excerpts quoted from the official white paper as cited earlier):

AI that is programmed by humans can contain a plethora of hidden risks.

I am not alluding to existential risks such as AI that rises and takes over humanity (we arent yet in that ballpark). The kind of AI that is being confronted consists of non-sentient algorithmic AI. Efforts to legislatively contend with algorithmic AI include the U.S. Congressional ongoing efforts toward crafting the Algorithmic Accountability Act, while in the European realm there is the EU Artificial Intelligence Act (AIA) currently under review.

An Appetizer But Not A Meal

You would be hard-pressed to argue against the proposed precepts of the newly unveiled AI Bill of Rights. The five keystones are indubitably sensible. It is possible to quibble with some of the wording here or there, but overall, the indicated protections are what we need to be diligently considering.

That being said, the AI Bill of Rights has perhaps only whetted our appetite. Envision that this is the precursor or appetizer leading up to a fuller meal.

We have already seen this appetizer in other guises, such as the US Department of Defense (DoD) officially statedEthical Principles of AI and even the somewhat comparabledirectivesby the Vatican in itsRome Call For AI Ethics. A much more extensive elucidation of these types of AI-relevant humankind rights was well-documented in theRecommendation on the Ethics of Artificial Intelligence released last year by UNESCO (United Nations Educational, Scientific, and Cultural Organization) which garnered adopted approval by 193 member countries of the United Nations [8].

In that sense, the AI Bill of Rights has a lot to draw upon and yet also measure up to.

The AI Bill of Rights can be said to be insufficient in many ways, including but not limited to:

Despite those aforementioned insufficiencies, there is certainly something to be said about trying to place a stick in the ground and get the ball rolling on the regulatory governance of AI. Apparently, selected areas of the U.S. federal government will attempt to try out the five keystones of the AI Bill of Rights (as suggested in the white paper as part of leading by example). The belief seems to be that this will illuminate the efficacy of the keystones and reveal ways to bolster and sharpen them.

Lawmakers are ultimately going to be in the drivers seat on all of this.

Those tasked with making our laws are going to be immensely challenged with the complicated chore of bringing together a veritable smorgasbord of recommended soft-law AI ethical practices and patchwork hard-law AI laws that are springing up throughout the states. Furthermore, our lawmakers should be wisely eyeing the globally emerging AI soft-laws and AI hard-laws that are available for the world to see and reuse.

Make no mistake, all of this is a burgeoning part of the law and growth is abundant.

Attorneys and law students will soon see that AI & Law is bubbling up to the surface. As more AI is devised and unleashed, companies and governments will need to seek out savvy AI-aware legal advisors. Meanwhile, the coming glut of new or imagined AI laws will require legal minds that can ensure that the laws as codified are sensible and practical. And the potential harms produced by AI will require lawyers that are willing to fight for humankinds rights against the blitz of dour AI systems.

Per the wisdom of Louis Brandeis, former Associate Justice of the U.S. Supreme Court: If we desire respect for the law, we must first make the law respectable.

Lets all get into the action and make humankinds rights associated with the advent of AI a top priority. It assuredly seems like a respectable thing to do.

About The Author

Dr. Lance Eliot is a global expert on AI & Law and serves as a Stanford Fellow affiliated with the Stanford Law School (SLS) and the Stanford Computer Science Department via the Center for Legal Informatics. His popular books on AI & Law are highly rated and he has been an invited keynote speaker at major law industry conferences. His articles have appeared in numerous legal publications includingMIT Computational Law Journal, Robotics Law Journal, The AI Journal, Computers & Law Journal, Oxford University Business Law (OBLB), New Law Journal, The Global Legal Post, Lawyer Monthly, Legal Business World, LexQuiry, The Legal Daily Journal, Swiss Chinese Law Review Journal, The Legal Technologist, Law360, Attorney At Law Magazine, Law Society Gazette, and others. Dr. Eliot serves on AI & Law committees for the World Economic Forum (WEF), United Nations ITU, IEEE, NIST, and other standards boards, and has testified for Congress on emerging AI high-tech aspects. He has been a professor at the University of Southern California (USC) and served as the Executive Director of a pioneering AI research lab at USC. He has been a top executive at a major Venture Capital (VC) firm, served as a corporate officer in several large firms, and been a highly successful entrepreneur.

Acknowledgment

This research is part of an ongoing initiative on AI & Law and thanks go to the Stanford University CodeX Center for Legal Informatics, a center jointly operated by the Stanford Law School (SLS) and the Stanford Computer Science Department. CodeX s emphasis is on the research and development of computational lawthe branch of legal informatics concerned with the automation and mechanization of legal analysis.

Suggested citation: Lance Eliot, U.S. Releases An AI Bill Of Rights That Though Encouraging Wont Yet Move The Needle, JURIST Academic Commentary, October 5, 2022, https://www.jurist.org/commentary/2022/10/u-s-releases-an-ai-bill-of-rights-that-though-encouraging-wont-yet-move-the-needle/.

This article was prepared for publication by Ingrid Burke-Friedman, Features Editor. Please direct any questions or comments to her at commentary@jurist.org

Opinions expressed in JURIST Commentary are the sole responsibility of the author and do not necessarily reflect the views of JURIST's editors, staff, donors or the University of Pittsburgh.

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U.S. Releases an AI Bill Of Rights That Though Encouraging Won't Yet Move the Needle - JURIST

California officials announced on Wednesday that the state will be awarding up to $20 million in marijuana tax-funded grants to universities that carry out research into cannabis science and policyincluding studies on preventing monopolies in the legal industry and securing the genetics of legacy strains.

This is the second round of academic marijuana grants from the Department of Cannabis Control (DCC), which said it is soliciting research proposals from public colleges with a focus on five priority study areas.

The department said that it developed the top research priorities in consultation with other state agencies, seeking to learn more about the implementation of cannabis legalization from economic vitality to public health to preservation of the states cannabis heritage.

Regulators previously issued $30 million in marijuana research grants to public universities across the state in 2020.

For this new round, DCC said it is looking for solicitations for projects that deal with cannabis potency and cannabinoid analysis, the health of the states marijuana industry, monopolies and unfair competition, legacy cannabis genetics and data on medical marijuana use.

California continues to direct millions of dollars to accelerate scientific understanding of cannabis and evaluate the impacts of legalization, DCC Director Nicole Elliott said in a press release. Decades of federal cannabis prohibition has hindered our collective knowledge related to these issues, to the detriment of consumers, communities, our environment and more.

Our hope is that research resulting from these grants proves beneficial not only to California policymakers but also to those across the nation and world, she said.

One of the more notable research objectives concerns anti-competitiveness in the industrya topic of growing interest as state markets across the U.S. have increasingly consolidated, raising concerns about the future of small cannabis businesses.

DCC said its seeking research and recommendations related to possible policies that would support reasonable competition, reduce anti-competitive behavior, uphold the ability of small businesses to compete in the legal market, or prevent the creation of monopolies within the California market.

California also seems to be leaning into its unique marijuana culture and economy by soliciting study proposals to identify and preserve the history, value and diversity of California legacy cannabis cultivars and the rich experience of its legacy cultivation community.

DCC said that genetic sequencing and chemical profiling of those legacy strains (e.g. Granddaddy Purple) could be part of that research.

Although grant funding is not limited to the identified topics, their prioritization provides additional direction to prospective grantees eager to help state cannabis leaders close gaps in research, the department said. The resulting research and data would continue to inform and support the creation of a safe, sustainable, and equitable cannabis market that protects people, safeguards the environment, and provides adult access to safe, tested products.

Study proposals will be accepted from November 1-30, and grant awardees will be announced in February 2023.

The academic funding opportunity was announced just days after California officials said that they would be accepting another round of applications for grants to support local efforts to promote equity in the marijuana industry.

The Governors Office of Business and Economic Development (GO-Biz) started accepting applications for an earlier round of grants under the programaround this time last year, with a total of $35 million made available for localities across the state. This years funding cap is set at $15 million.

The department separately distributeda round of community reinvestment grantsearlier this year totaling $35.5 million with tax revenue generated from recreational marijuana sales.

GO-Biz announced in July that theyve awarded 78 grants to organizations throughout the state that will support economic and social development in communities disproportionately impacted by the war on drugs. The amount of funding and number of recipients for that programincreased from last years levels, when the state awarded about $29 million in grants to 58 nonprofit organizations through the CalCRG program.

Meanwhile, the state is also taking steps to bring more marijuana businesses above board as it continues to mitigate the illicit market.

California started granting provisional marijuana business licenses as a way to more quickly stand up the adult-use market. That temporary licensing category was set to expire last year, but it was extended to give localities more time to complete the permitting process and meet environmental requirements.

Since then, the state has identified a number of jurisdictions that may need additional support to get those provisional licensees into the traditional, annual license category. A separate grant program run by the Department of Cannabis Control (DCC) is providing that licensure funding.

Ensuring that localities are able to effectively stand up a regulated industry is especially important in California, where more than half of the states jurisdictions havebanned cannabis businesses from operating in their area, which has helped sustain the illicit trade.

Gov. Gavin Newsom (D), along with regulators and lawmakers, have attempted to resolve the issue through different means.

The governor has signedabout a dozen pieces of cannabis reform legislationin the past month, including one proposal that will prevent localities from blocking medical cannabis deliveries, along with measures on interstate cannabis commerce, employment protections for consumers and record sealing of past convictions.

Marijuana Moment is tracking more than 1,500 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they dont miss any developments.Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

The legislaturedelivered numerous cannabis bills to Newsomnear the end of the session, and he acted on the majority of them in one fell swoop last month. The governor said the reforms were necessary to help fulfill the promises of legalization and continue to address the collateral consequences of prohibition.

Newsom as a long record of supporting marijuana reform and backing the states market, so hes generally been expected to sign reform measures delivered to his desk. But despite his record, he recentlyvetoed a key piece of drug policy reform legislationthat would have authorized a safe drug consumption site pilot program in the statea move thats prompted widespread criticism from the harm reduction community.

San Francisco officials have since signaled thattheyre prepared to defy the governorand launch an overdose prevention program regardless of the veto.

In another disappointment for reform advocates, a separate bill that would have legalized possession of limited amounts of certain psychedelics was recentlypulled by the sponsor after its main provisions were gutted, leaving just a study component that advocates say is unnecessary given the existing body of scientific literature on the subject.

Heres an overview of other recent drug policy developments in California:

In July, California officialsawarded more than $1.7 million in grantshelp promote sustainable marijuana cultivation practices and assist growers with obtaining their annual licenses. A total of $6 million will be allotted through the program,which was first announced in August 2021and will remain open for applications through April 2023.

Regulators also recently announced that they are soliciting input onproposed rules to standardize cannabis testing methodsin the statean effort that they hope will stop marijuana businesses from laboratory shopping to find facilities that are more likely to show higher THC concentrations that they can then boast for their products.

California hastaken in nearly $4 billion in marijuana tax revenuesince the states adult-use market launched in 2018, the Department of Tax and Fee Administration (CDTFA) reported in July. And for the first quarter of 2022, the state saw about $294 million in cannabis revenue generated from the excise, cultivation and sales tax on marijuana.

The state collected about$817 million in adult-use marijuana tax revenueduring the last fiscal year. That represented 55 percent more cannabis earnings for state coffers than was generated in the 2020-2021 period.

Three In Four Maryland Voters Support Marijuana Legalization Referendum, Including Majority Of Republicans, Poll Finds

Photo courtesy of Brian Shamblen.

Original post:
California Funds Research On Blocking Marijuana Monopolies And Protecting 'Legacy' Cannabis Strains - Marijuana Moment

By Kate Cook, Catherine M. Cook Group, LLC

In the past two years, the pandemic has kept sponsors developing drugs, biological products, and medical devices from meeting in person with FDA.Advisory committee meetings, workshops, and conferences have gone virtual, too. While some sponsors have hopes that changing pandemic conditions will open the doors to in-person meetings, this seems unlikely.

In-person meetings with FDA officials are likely to remain the rare exception, not the norm.The FDA commitment letter developed in the latest round of prescription drug user fee negotiations sets out FDAs commitments to meet face to face with the sponsor at specified stages in a product development program, but defines face-to-face to include... both in-person meetings and virtual meetings on IT platforms that allow for both audio and visual communication.

This means that FDA can opt to meet virtually instead of in person, and it has strong reasons to do so. Meeting virtually avoids the administrative work needed to bring outsiders onto the secure FDA campus, and the format more easily accommodates individual employee schedules.There are very clear scheduling advantages to virtual advisory committee meetings, which are easier to schedule when busy experts are not required to spend a half day or more traveling to and from an in-person meeting.

Moreover, it can seem impossible to bring FDA meeting participants together in one conference room. FDA staff are increasingly likely to be working remotely at locations nowhere near the FDAs White Oak campus in Maryland. FDA officials have made recent statements about the value in authorizing remote work as a recruitment tool, and it is a tool FDA is likely to be using.

FDA has a lot of recruiting to do.In the latest round of user fee agreements, the agency committed to significant numbers of targeted hires to support the prescription drug user fee program, including, for Fiscal Year 2023, 132 CBER staffers and 77 CDER staffers.Recruiting qualified scientific employees is always a challenge for FDA, but it will also need to address recent staff departures.Exhausted by the work of developing and supporting the FDAs pandemic response, experienced staff members are retiring or seeking outside employment in significant numbers.This exacerbates existing understaffing and can lead to significant losses of expertise and institutional memory.

Once these hundreds of new employees are hired, FDA will have to develop employees who work remotely and do not have the benefit of daily in-person interactions with their managers and mentors who may also be working remotely. This will present management and supervisory challenges for the agency and may change its work culture significantly. One thing for sponsors to look out for is that new reviewers sometimes default to an overly conservative position. Sometimes, it may be necessary for sponsors to ensure that supervisors are involved in giving FDA advice, particularly on novel issues.

The primary mechanism for sponsors to obtain advice from FDA on their development programs is by filing a request for a meeting. When FDA grants the meeting, it may be a face-to-face meeting (defined to include a virtual meeting), a teleconference, or a written response only. FDA and industry have described different meeting types in user fee commitment letters for prescription drugs and biological products (PDUFA), biosimilars (BsUFA), generic drugs (GDUFA), and medical devices (MDUFA) as well as in related guidance documents addressing meetings under PDUFA, BsUFA, GDUFA, and MDUFA.

These guidance documents are likely to be revised to incorporate new user fee commitments under the recently concluded negotiations, once Congress has enacted the legislation necessary to reauthorize these user fee programs. For example, the new PDUFA commitment letter addresses two types of meetings for the first time: INTERACT meetings and Type D meetings. An INTERACT meeting provides an opportunity for sponsors to discuss novel questions and unique challenges in early development, prior to filing an IND.A Type D meeting is focused on a narrow set of issues (typically not more than two issues and associated questions). Requests could include a follow-up question that raises a new issue after a formal meeting, a narrow issue on which the sponsor is seeking agency input with only a few associated questions, or a general question about an innovative development approach that does not require extensive, detailed advice.

FDAs commitment letters and guidance documents describe the criteria the sponsor must meet to be granted a specific type of meeting. Although FDAs user fee commitments recognize a right to a face-to-face meeting at certain stages in a product development program, under other circumstances FDA may decline to schedule a face-to-face meeting and will provide a written response only.The commitment letters and guidance documents address the timeframes for the sponsor to submit their briefing document and for FDA to respond to requests and to schedule meetings.

FDA has committed to send preliminary written responses to a sponsors questions contained in their background package.When a meeting has been scheduled, FDA will send the response in advance of the meeting, giving the sponsor the opportunity to focus the meeting on discussing certain FDA responses, or even to determine that the written response is adequate and a meeting is no longer necessary.

Some sponsors want to initiate meetings with FDA as early in development as possible. FDA has recognized that emerging technologies raising cross-cutting issues may warrant very early discussion and has created forums for such discussions in the Critical Path Innovation Meeting, CDERs Emerging Technology Team Meeting, and the CBER Advanced Technology Team Meeting. However, a sponsor that obtains advice too early in preclinical development of a specific product may find that significant pre-IND questions arise a short time after a pre-IND meeting because they decided to modify the product in important ways.Since FDA generally limits a sponsor to one pre-IND meeting, the sponsor may have to ask for advice on their new questions using a different meeting request format, such as a Type C meeting, which has longer timelines for agency response, or the new Type D meeting if FDA agrees that the scope is narrow enough for such a meeting.FDA has advised that for products regulated by CBERs Office of Tissues and Advanced Therapies (responsible for regulating cell and gene therapies, among other biological products), a pre-IND meeting is appropriate if:

A sponsor should assure that all sponsor attendees can access the video conference platform successfully, and that audio is clear and bug-free.The sponsors meeting plans should address not only who is responsible for the sponsors presentation, but also who is the critical note taker and who is authorized to call for a short internal conference if needed during the meeting.The sponsor should be able to mute the sound to FDA in case there is a need to hold a sidebar with sponsor attendees only.

If possible, all sponsor attendees should assemble at the same location.This can be challenging, given that sponsor employees often work at different locations and that a sponsors external consultants may be in attendance, but having everyone in the same room can allow a sponsor to adjust strategy in real time after an internal sidebar discussion.If it is necessary for sponsor representatives to participate from multiple locations, participants should have a plan in place to address the problems that can occur when one site loses connectivity.This may include identifying and preparing back-up presenters for critical presentations.

In addition, the sponsor should think about how their representatives are likely to present themselves to FDA and be on the lookout for presenters who may come across as dismissive of FDA questions and concerns.

A sponsors briefing book should make its case in support of the sponsors position on the issues they are asking FDA to advise on. This is especially important for a sponsor seeking FDA support for an innovative or less burdensome approach.If specific subject matter expertise is important to understanding the issues, a sponsor should request the participation of specific FDA employees or representatives of specific offices.For example, if an issue requires CMC or other manufacturing expertise, the sponsor may request the involvement of a representative from CDERs Office of Pharmaceutical Quality or CBERs Office of Compliance and Biologics Quality.

A sponsors primary point of contact with FDA is the project manager assigned to the development program.Sponsors regulatory affairs personnel generally understand the value of a good relationship with the project manager, who can sometimes work magic in facilitating informal communications between the sponsor and regulators.

FDAs written response to a briefing package may identify issues of concern to FDA.The sponsor should take every opportunity to probe the scope and significance of these concerns in the meeting and in future product development discussions.It sometimes happens that FDA raises an issue in early correspondence with a sponsor whose application for approval, filed years later, is not successful due to the same issue raised in early communications. Sometimes the early notice has prepared the sponsor for this possibility, and the sponsor is ready to make its case for approval on appeal or has already initiated studies to develop data to satisfy FDAs concern.However, sometimes the sponsor will have discounted the significance of FDAs early comments and is unprepared to address them.

A sponsor should also pay attention to the FDA staff attending the meeting.If you are unfamiliar with someone and their FDA role, do a little research.You may learn from an attendees slide presentations that they specialize in a specific issue, such as the distribution of a drug under a Risk Evaluation and Mitigation Strategy (REMS) program.This may signal that the parameters of a REMS distribution program for your drug are the subject of discussion within FDA. Similarly, the involvement of other individuals or offices may signal that FDA is focusing on a drug exclusivity or other type of issue.

Conclusion

The processes for using meeting requests to interact with FDA may seem overly formal, but a sponsor who follows them carefully, submits high-quality briefing materials, and maximizes their meeting opportunities will maximize their chances of receiving high-quality agency feedback. In addition to the assigned reviewers, a sponsors briefing book will also be read by FDA supervisors, whose supervisory and oversight roles may become more important and more challenging as they are called upon to train, mentor, and develop remote workers.

About The Author:

Kate Cook is an FDA veteran who has worked in legal and policy positions in the Office of Chief Counsel, as well as in the FDA's CBER and CDRH, where she served as associate director for regulations and policy.For more than 20 years, she was involved in every aspect of policy development, authoring or reviewing many regulations and guidances. Since she left the agency in 2016, she has worked as a regulatory attorney and consultant, helping her clients in their interactions with the FDAs medical product centers and on appeals to the Office of Commissioner. Cook graduated from Swarthmore College and the New York University School of Law, and was a New York County Assistant District Attorney and an attorney in private practice before joining the FDA. She founded the Catherine M. Cook Group, LLC, in 2022, and can be reached at Kate.Cook@CatherineMCook.com.

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Tips For Your Virtual Meetings With The FDA - Med Device Online

NEW YORK, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Sema4 Holdings Corp. (NASDAQ: SMFR, SMFRW), Medtronic PLC (NYSE: MDT), Palantir Technologies, Inc. (NYSE: PLTR), and Fulgent Genetics, Inc. (NASDAQ: FLGT). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

Sema4 Holdings Corp. (NASDAQ: SMFR, SMFRW)

Class Period: March 14, 2022 August 15, 2022

Lead Plaintiff Deadline: November 7, 2022

On August 15, 2022, after the market closed, Sema4 announced changes to its research and development leadership team, including that Defendant Schadt was stepping down from his roles as President and Chief R&D Officer. The Company also disclosed that it was eliminating approximately 13% of its workforce as part of a series of restructuring and corporate realignments. During the related conference call, Sema4 revealed that it had reversed $30.1 million of revenue this quarter related to prior periods, in connection with negotiations with one of [Sema4s] larger commercial payors regarding the potential recoupment of payments for Sema4 carrier screening services rendered from 2018 to early 2022.

On this news, Sema4s stock fell $0.80, or 33.3%, to close at $1.60 per share on August 16, 2022, on unusually heavy trading volume.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that there was a significant risk that Sema4 would reverse a material amount of previously recognized revenue that it could not recoup from third party payors; (2) that the Company was experiencing declining selling prices for its reproductive health segment; (3) that, as a result of the foregoing, Sema4s financial results would be adversely affected; and (4) that, as a result of the foregoing, Defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Sema4 class action go to: https://bespc.com/cases/SMFR

Medtronic PLC (NYSE: MDT)

Class Period: June 8, 2019 May 25, 2022

Lead Plaintiff Deadline: November 7, 2022

Medtronic is a medical device company. Among its products is the MiniMed insulin pump system for the treatment of diabetes. The systems include the MiniMed 600 series models and the MiniMed 780G model. Medtronic is currently seeking regulatory approval for the MiniMed 780G model, which uses an advanced hybrid closed loop system. During the Class Period, Medtronic repeatedly assured investors that the MiniMed 780G model was on track for approval by the U.S. Food and Drug Administration (FDA) and would provide Medtronic with the edge it needed to close a growing gap with its competitors in the diabetes market.

Medtronic made these representations despite known issues with the MiniMed 600 series models. Indeed, in November 2019, the company issued a warning that certain MiniMed 600 series insulin pumps might have damaged pump retainer rings, which could cause the system to release too much insulin, and instructed customers with damaged rings to contact the company for replacements. On February 7, 2020, the FDA classified Medtronics November 2019 notification as a Class I recallthe most serious type of recall.

Problems with the MiniMed 600 series mushroomed in October 2021, when the company expanded its recall to all MiniMed model 630G and 670G insulin pump systemswhether or not any retainer ring damage was actually visible. Despite these serious issues with the 600 series, Medtronic assured investors that they expected the MiniMed 780G to drive growth. Consistent with these optimistic statements, Medtronic again assured investors that FDA approval of the MiniMed 780G was imminent.

Investors began to learn the truth about the companys MiniMed operations on December 15, 2021, when Medtronic revealed that it had received a warning letter from the FDA regarding its Northridge, California facility (the Warning Letter). The Warning Letter followed an FDA inspection relating to the companys MiniMed 600 series recall, and focused on the inadequacy of specific medical device quality system requirements . . . in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.

As a result of the Warning Letterincluding the resulting uncertainty about FDA approval of the MiniMed 780G and other products in Medtronics diabetes operating unit, the Diabetes Group, Medtronic lowered its guidance for its Diabetes Group, now projecting that Diabetes Group product revenues would decline in the mid-single digit range for fiscal year 2022. On this news, the price of Medtronic common stock declined $6.75 per share, or approximately 6%, from a close of $111.69 per share on December 14, 2021, to close at $104.94 per share on December 15, 2021.

The financial fallout from the FDAs findings continued to surface on May 26, 2022, when Medtronic reported its financial results for the fourth quarter and full fiscal year 2022, and provided guidance for fiscal year 2023. Notably, Medtronic disclosed that as a result of the companys need to improve its quality control system and its expectation that the MiniMed 780G modelwhich Defendants had repeatedly identified as crucial to future growthwould not be approved in 2023, the company expected revenues from its Diabetes Group to decline between 6% and 7% in fiscal year 2023. On this news, the price of Medtronic common stock fell $6.10 per share, or nearly 6%, from a close of $105.54 per share on May 25, 2022, to close at $99.44 per share on May 26, 2022.

Throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts, about the companys business and operations by failing to disclose that: (1) Medtronics product quality control systems were inadequate; (2) Medtronic had failed to comply with numerous regulations regarding risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events; (3) these failures increased the risk of regulatory investigation and action; (4) as a result of the companys misconduct, the FDA would delay the approval of additional Medtronic MiniMed devices, including the MiniMed 780G; (5) these delays in product approvals, as well as the companys need to improve its quality control systems, would negatively affect Medtronics financial performance and cause it to fall further behind its competitors; and (6) as a result of the foregoing, Defendants statements about the companys business, operations, and prospects lacked a reasonable basis.

For more information on the Medtronic class action go to: https://bespc.com/cases/MDT

Palantir Technologies, Inc. (NYSE: PLTR)

Class Period: November 9, 2021 May 6, 2022

Lead Plaintiff Deadline: November 14, 2022

Palantir builds and deploys software platforms to assist the U.S. intelligence community in counterterrorism investigations and operations. The Company has two operating segments, commercial and government,with the latter primarily serving agencies in the U.S. federal government and non-U.S. governments. Palantir also invests in so-called marketable securities consisting of equity securities in publicly-traded companies.

Palantir has consistently described sources of geopolitical instability and other disruptions e.g., armed conflicts, economic crises, and the COVID-19 pandemicas tailwinds for its business, given that the Companys products and services are purportedly built to aid its customers in assessing and responding to such disruptions.

On May 9, 2022, Palantir issued a press release announcing its Q1 financial results and guidance for Q2. For Q1, Palantir announced adjusted EPS of $0.02, compared to analyst estimates of $0.04 per share, noting on a conference call that the [f]irst quarter adjusted [EPS of] $0.02 . . . includes a negative $0.02 impact driven primarily by unrealized losses on marketable securities. The Company also disclosed that government revenue grew by only 16% year-over-year for Q1, representing a significant slowdown in revenue growth compared to prior quarters, and that, for Q2, the Company expected $470 million in sales, compared to estimates of $483.76 million.

On this news, Palantirs stock price fell $2.02 per share, or 21.31%, to close at $7.46 per share on May 9, 2022.

As multiple news outlets reported that day, Palantirs significant decline in revenue growth, particularly from its government customers, surprised investors, especially given the ongoing geopolitical instability and other disruptions caused by, inter alia, the ongoing COVID-19 pandemic and Russo-Ukrainian Warthat is, precisely the type of destabilizing conditions that the Company had previously touted as tailwinds for its business.

The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Companys business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Palantirs investments in marketable securities were having a significant negative impact on the Companys earnings per share (EPS) results; (ii) Palantir overstated the sustainability of its government segments growth and revenues; (iii) Palantir was experiencing a significant slowdown in revenue growth, particularly among its government customers, despite ongoing global conflicts and market disruptions; (iv) as a result of all the foregoing, the Company was likely to miss consensus estimates for its first quarter 2022 (Q1) EPS and second quarter 2022 (Q2) sales outlook; and (v) as a result, the Companys public statements were materially false and misleading at all relevant times.

For more information on the Palantir class action go to: https://bespc.com/cases/PLTR

Fulgent Genetics, Inc. (NASDAQ: FLGT)

Class Period: March 22, 2019 August 4, 2022

Lead Plaintiff Deadline: November 21, 2022

Fulgent, together with its subsidiaries, provides COVID-19, molecular diagnostic, and genetic testing services to physicians and patients in the United States and internationally. As a result, Fulgent must comply with the federal Anti-Kickback Statute, which prohibits the knowing and willful payment of remuneration to induce or reward patient referrals or the generation of business involving any item or service payable by the Federal health care programs, as well as the federal Stark Law, which prohibits a physician from making referrals for certain designated health services, including laboratory services, that are covered by the Medicare program, to an entity with which the physician or an immediate family member has a direct or indirect financial relationship.

On August 4, 2022, Fulgent released its second quarter 2022 financial results, disclosing, among other items, that the US Securities and Exchange Commission (SEC) was conducting an investigation into certain of the Companys reports filed with the SEC from 2018 through the first quarter of 2020. The disclosure followed the Companys receipt of a civil investigative demand issued by the U.S. Department of Justice related to its investigation of allegations of medically unnecessary laboratory testing, improper billing for laboratory testing, and remuneration received or provided in violation of the Anti-Kickback Statute and the Stark Law.

On this news, Fulgents stock price fell $11.02 per share, or 17.29%, over the following two trading sessions, to close at $52.72 per share on August 8, 2022.

The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Companys business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Fulgent had been conducting medically unnecessary laboratory testing, engaging in improper billing practices in relation to laboratory testing, and providing or receiving remuneration in violation of the Anti-Kickback Statute and Stark Law; (ii) accordingly, Fulgent was likely to become subject to enhanced legal and regulatory scrutiny; (iii) Fulgents revenues, to the extent they were derived from the foregoing unlawful conduct, were unsustainable; (iv) the foregoing, once revealed, was likely to subject the Company to significant financial and/or reputational harm; and (v) as a result, the Companys public statements were materially false and misleading at all relevant times.

For more information on the Fulgent class action go to: https://bespc.com/cases/FLGT

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit http://www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contact Information:

Bragar Eagel & Squire, P.C.

Brandon Walker, Esq.

Melissa Fortunato, Esq.

(212) 355-4648

investigations@bespc.com

http://www.bespc.com

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Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed ... - The Bakersfield Californian

LONDONandNEW YORK, Oct. 04, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc(Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company will exhibit 15 poster presentations at the European Society of Gene and Cell Therapy (ESGCT) 2022 Annual Congress, which will be held from October 11-14, 2022, in Edinburgh, Scotland.

The posters will include data from MeiraGTxs novel gene regulation platform, including the first data demonstrating the potential to regulate CAR-T, as well as data from the Companys promoter platforms and several new, optimized pre-clinical programs addressing severe unmet needs for indications such as amyotrophic lateral sclerosis (ALS) and Wilsons disease. In addition, the Company will have presentations on its proprietary viral vector manufacturing technology and potency assay development.

Were pleased to present data illustrating the depth and versatility of MeiraGTxs scientific platforms, said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. The 15 published abstracts at this years ESGCT Congress reflect the extraordinary productivity of our research efforts in developing new technologies and applying them to the design of optimized genetic medicines, as well as innovation in manufacturing and process development technology. I am particularly excited for us to present our riboswitch gene regulation technology applied to cell therapy for the first time, in this case the regulation of CAR-Ts, which is a huge area of scientific and clinical interest, continued Dr. Forbes. We look forward to presenting these data highlighting our innovative platform technologies and broad R&D capabilities.

Abstract Title (P101): AI-driven promoter optimization at MeiraGTxSession Title: Advances in viral and non-viral vector designDate: October 12, 2022

Abstract Title (P124): Promoter Engineering Platform at MeiraGTxSession Title: Advances in viral and non-viral vector designDate: October 13, 2022

Abstract Title (P243): UPF1 delivered by novel expression-enhanced promoters protects cultured neurons in a genetic ALS modelSession Title: CNS and sensoryDate: October 12, 2022

Abstract Title (P254): Optimization and scale-up of AAV2-AQP1 production using a novel transient transfection agentSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P264): Designing and screening formulations to improve manufacturability and distribution of AAV gene therapiesSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P270): Use of anion exchange chromatography to provide high empty AAV capsid removal and product yieldsSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P320): Multivariate analysis for increased understanding of MeiraGTx upstream processSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P362): Development of AAV-UPF1 gene therapy to rescue ALS pathophysiology using microfluidic platformsSession Title: Disease models (iPS derived and organoids)Date: October 13, 2022

Abstract Title (P399): Titratable and reversible control of CAR-T cell receptor and activity by riboswitch via oral small moleculeSession Title: Engineered T and NK CARs and beyondDate: October 12, 2022

Abstract Title (P436): Novel riboswitches regulate AAV-delivered transgene expression in mammals via oral small molecule inducersSession Title: Gene and epigenetic editingDate: October 13, 2022

Abstract Title (P553): Development of optimized ATP7B gene therapy vectors for the treatment of Wilsons Disease with increased potencySession Title: Metabolic diseasesDate: October 12, 2022

Abstract Title (P554): A CNS-targeted gene therapy for the treatment of obesitySession Title: Metabolic diseasesDate: October 13, 2022

Abstract Title (561): Riboswitch-controlled delivery of therapeutic hormones for gene therapySession Title: Metabolic diseasesDate: October 12, 2022

Abstract Title (P622): Riboswitch-controlled delivery of therapeutic antibodies for gene therapySession Title: OtherDate: October 13, 2022

Abstract Title (P630): Improving AAV in vitro transducibility for cell-based potency assay developmentSession Title: OtherDate: October 13, 2022

About MeiraGTxMeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, and a transformative gene regulation platform technology which allows tight, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring, and developing technologies that give depth across both product candidates and indications. MeiraGTxs initial focus is on three distinct areas of unmet medical need: ocular, including inherited retinal diseases and large degenerative ocular diseases, neurodegenerative diseases, and severe forms of xerostomia. Though initially focusing on the eye, central nervous system, and salivary gland, MeiraGTx plans to expand its focus to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

For more information, please visit http://www.meiragtx.com.

Forward Looking StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and our pre-clinical data and reporting of such data and the timing of results of data, including in light of the COVID-19 pandemic, as well as statements that include the words expect, will, intend, plan, believe, project, forecast, estimate, may, could, should, would, continue, anticipate and similar statements of a future or forward-looking nature. These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of the COVID-19 pandemic on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SECs website at http://www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts

Investors:MeiraGTxInvestors@meiragtx.com

Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com

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MeiraGTx Announces the Upcoming Presentation of 15 Abstracts at the European Society of Gene and Cell Therapy (ESGCT) 2022 Annual Congress -...

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Neighborhood deprivation and coronary heart disease in patients with bipolar disorder | Scientific Reports - Nature.com

Have insurers and defendants been overpaying for asbestos liability claims? Are there other ongoing toxic torts where that might be true today?

The questions arise as a result of a revolution thats now underway in genomic analysis and its application in civil litigation.

Genomic analyses of molecular data can allow medical scientists to identify an individuals genetic propensity to develop cancers like mesothelioma and other conditions. Beyond that, the frequency with which genomic analyses have been used in personal injury casesby both plaintiffs and defendantsis increasing rapidly.

How It Started

An early, impressive use of genomic analysis was in Bowen v. E.I. DuPont de Nemours & Co., 906 A.2d 787 (2006). There, children were born with heart-rending deformities, including malformed eyes. The claim was that fungicide exposure caused the deformities.

Shortly before trial, newly published, peer reviewed research showed that a pathogenic mutation to a particular gene (CHD7) could be the cause of the deformities, independent of any exposure to the fungicide. Genetic testing revealed the children at issue in fact carried pathogenic mutations to the CHD7 gene.

Ultimately, the genetic testing results caused plaintiffs experts to withdraw their prior opinions on causation, and so summary judgment was entered for the defendant fungicide maker.

Since then, there have been numerous orders around the country requiring some amount of genetic testing in a wide range of cases; the orders usually are in cases involving claims of medical malpractice, product liability and negligence. There have been some state-to-state variations and some denials of genetic testing, mainly when counsel did not make a detailed record. And some plaintiff lawyers undertake their own genetic testing before investing heavily in a case or make arguments based on the results of genetic tests.

The Asbestos Question

Many insurance claims professionals have been conditioned to think that virtually anyone who encountered asbestos in their career or life, and subsequently developed mesothelioma, probably had their disease caused by that exposure. Advances in genomics now reveal, however, that this is not necessarily true.

In fact, genomic analyses have scientifically established that a meaningful percentage of mesotheliomas are caused solely by genetic mutations, a fact that holds true for virtually all cancers. Those scientific findings are now reshaping expert testimony in mesothelioma litigation. In very recent deposition testimony (May and June of 2022) a genetic expert often called by plaintiffs (Dr. Joseph Testa) finally acknowledged that, in fact, some mesotheliomas are caused solely by genetic abnormalities.

That overdue acknowledgement arose from multiple factors:

But have insurers been overpaying on asbestos liability claims?

The answer is complicated by group settlements and the fact that there are so many repeat players in mesothelioma cases, thereby inducing trade-offs between cases. In short, yes, settlement payments have been made in some cases where asbestos causation was highly dubious or implausible. And importantly, there soon may well be bad faith claims against insurers who fail to fund genomic defenses in appropriate cases.

Genomic analyses can be highly effective in both mass tort and individual cases. Genomic analysis reports are unique to each person, and so costs are higher than costs for generic reports that have been used hundreds of times over many years and that include only a few paragraphs specific to the person. The costs for genomic analyses, however, are relatively small when compared to the potential jury verdicts in cases involving a person under 60 who has a terminal, painful cancer, especially in view of todays so-called nuclear verdicts. Logically, this potential for outsized verdicts compared to the cost of genomic defenses could fuel bad faith claims against insurers going forward.

The Economics: When to Use Genomic Analyses

Still, the question of precisely when it becomes economical to pursue genomic analysis as part of a defense doesnt have a clear-cut answer.

Genomic defenses are credible and appropriate only in some cases. An initial step is to look for the presence or absence of red flags (a term of art in the genetics literature) that suggest the likely or possible presence of pathogenic hereditary mutationsfor example, personal and family histories of cancer. For defendants, the presence of red flags can suggest investing in genomic analyses for high-value cases or to send a message to plaintiffs counsel to discourage suits against a defendant that does not belong in the case. Consider the math when the plaintiff has targeted only one or two defendants, the plaintiff is relatively young and successful, and counsel is seriously demanding eight-figures to settle the case.

Tsunamis Ahead

Hundreds of thousands of whole genome sequences, linked to anonymized medical data, are on the cusp of arriving at researchers doorsteps with the prospect of transforming both the scientific and legal systems.

Insurers need to understand the speed and scale of advances in this genomic knowledge. The next 10 years will bring multiple tsunami waves of genomic information. The first tsunami arrived last year with a UK groups release of 200,000 whole genome analyses, accompanied by anonymized medical records. Another tsunami will arrive in 2023 with the same groups release of an additional 300,000 whole genomes and anonymized medical records.

Assured Research LLC, a research and advisory firm focused exclusively on the P/C insurance industry, has been working with Law Science Policy law firm since 2015, when the two firms joined forces to describe the scientific, medical, and legal developments shaping a possible third wave of asbestos liabilities. (Related 2015 article, Genetic Markers May Fuel Next Wave of P/C Insurer Asbestos Reserve Hikes)

Since then, William Wilt, president of Assured Research, and Kirk Hartley, founder and principal of LSP, have spoken about these developments to actuarial and insurance audiences, hoping to impress upon insurance professionals the imperative of understanding the revolution now underway in genomic/medical analysis and its application in civil litigation. Hartley also teamed up with a multidisciplinary group of scientists and lawyers to create ToxicoGenomica, which provides fully integrated services for using genomic and systems biology data in civil litigation. ToxicoGenomica scientists have recently published articles showing that mesotheliomas and other cancers can be caused solely by genetic abnormalities, rather than by exposure to asbestos and other substances.

As a result of that research, and forthcoming waves of genomic data that will fuel more research in the next few years, Wilt and Hartley believe that insurers can no longer delay decisions to invest time, effort and money in understanding the application of genomic analysis to civil litigation. They delivered their urgent message is an Aug. 16, 2022, research note, Liability Insurance: Invest in Genomics Now, the Future is Arriving, published by Assured Research. The research note is presented in the form of a Q&A style discussion, with Wilt asking the questions and Hartley supplying the answers.

The accompanying article has been adapted from that research note with permission from the authors.

The tsunamis will continue as more whole genomes and medical records are released from government programs or other databases (see the chart for examples).

The medical records and genomes are now being mined, and disease-specific papers are now being released that far more reliably link specific genes to specific diseases, while other papers show gene/environment interaction. These genomic epidemiology papers in some instances will exonerate defendants and other times will support plaintiffs. Both outcomes create risks of major surprises for stakeholders who are not tracking genomic science as it advances. Stakeholders and lawyers need to start thinking about how they are going to cope with so much risk of a rapid change, and the fact that new knowledge will 1) effect pending claims, 2) may stimulate new claims, and 3) will influence underwriting considerations.

Even though the use of genomics could work for, or against, the defense (e.g., maybe it shows that a toxin was highly likely to have caused the plaintiffs disease), the best move for insurers is to engage early and intelligently in order to avoid extreme surprises. Simply put, the availability of massive amounts of anonymized medical records and matched genomic data is a never before event, and so existing actuarial models simply cannot be as reliable as they are for many other risks. The arrival of genomic epidemiology will not impose surprises and changes as fast or as broadly as did the arrival of COVID. But it seems realistic to suggest the need to manage change and the new data, perhaps by analogizing to the recent development of new forms of extreme weather models based on data and analytic methods that were not available 10 or even five years ago.

The volume of data truly will arrive in tsunamis, and the impact will be highly material for some toxicants. Actuaries simply will not find workable prior models; new methods and models are needed to better manage the changes that will arrive with hundreds of thousands and then millions of anonymized medical records and associated genomic data.

We cant predict the path or exact ramifications of the tsunami of genomic/medical data to be released over the upcoming decade. But, with great confidence, we can predict that insurers sticking their head in the sand take the risk of surprises and outcomes that could have been avoided.

The time has arrived to invest resources and, yes, money in understanding this scientific revolution and its ramifications for the liability landscape.

The accompanying article has been adapted from a Aug. 16, 2022 research note titled Liability Insurance: Invest in Genomics Now, the Future is Arriving, published by Assured Research. Wells Media is publishing with permission from the authors.

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Have Insurers Paid Too Much for Asbestos and Other Toxic Torts? - Claims Journal

During a pregnancy, women are offered prenatal genetic screening and diagnostic testing to determine whether a fetus is healthy or has certain genetic disorders or anomalies.

This information can help patients and their doctors prepare for the pregnancy. But some opt out of such testing, believing that babies should be born regardless of potential abnormalities.

For those who do choose to undergo such testing, maternal-fetal medicine specialists and genetic counselors usually work closely with the pregnant person or couple to explain in detail what the results mean for a birth, for mother and child, if a genetic disorder or fetal anomaly is detected. These health care providers can also provide the pregnant person or couple with guidance on what options are available to them after a diagnosis, which can include aborting apregnancy. That option, however, is limited or no longer available to women in many U.S. states.

Prenatal tests cant diagnose a genetic condition before 6 weeks

Without the protection of Roe v. Wade, the 1973 Supreme Court decision that legalized abortion nationwideand was overturnedin June, the procedure has become illegal or heavily restricted in at least 14 states. Six states Mississippi, Missouri, Tennessee, North Dakota, South Dakota and Ohio prohibit abortions when the fetus may have a genetic anomaly, and infive of those states, its now nearly impossible, because it is banned at about six weeks. This is so early in a pregnancy that many women at that point dont even know they are carrying a child.

A person's first [doctors] appointment in pregnancy doesn't usually happen until eight or 10 weeks, so never mind the rest of the story. That's when obstetric care begins, said Philip D. Connors, lead genetic counselor at Boston Medical Center.

Three [percent] to 4% of all pregnancies are going to be affected by some sort of complication related to a difference in fetal or embryonic development, a genetic condition. And essentially none of those can be screened for or diagnosed until after the gestational age limits that are being placed by some of these really discriminatory laws, Connors added.

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Dr. Tani Malhotra, a maternal-fetal medicine specialist in Cleveland,Ohio, a state where abortions are now illegal after six weeks and where there are no exceptions for cases of rape, incest or fatal fetal anomalies, said it is impossible to assess whether there are any issues with the fetus at such an early point in pregnancy.

The size of the embryo at six weeks is somewhere between 6 to 7 millimeters. It's less than 1 centimeter, and that centimeter is like the size of my finger, right? So it's just impossible for us to be able to detect abnormal findings on an ultrasound at that point, Malhotra said.

KatieSagaser, director of genetic counseling at Juno Diagnostics, a women's health company, told Yahoo News: Theres no genetic testing or screening that can be done prior to six weeks.

One method of testing which she said has revolutionized the landscape of prenatal chromosome screening and is mostly used today is a noninvasive prenatal screening technology known as NIPT or NIPS. This can detect genetic variations as early as nine weeks into pregnancy, using a blood sample from the mother. But the test, Sagaser said, can only indicate if there is a potential problem, and does not replace diagnostic testing, such as chorionic villus sampling (CVS) or amniocentesis, which study the cells from the fetus or placenta and can confirm a diagnosis.

The earliest a CVS diagnostic test can be performed is at the 10th week of pregnancy. Amniocentesisis usually conducted at between 15 and 20 weeks of pregnancy, but can technically be done up until a person gives birth, according to the American College of Obstetricians and Gynecologists.

WASHINGTON, DC - JUNE 24: Abortion-rights activists gather in front of the Supreme Court building following the announcement to the Dobbs v Jackson Women's Health Organization ruling on June 24, 2022 in Washington, DC. (Photo by Nathan Howard/Getty Images)

Aborting a pregnancy because of genetic anomalies

As prenatal screening testing like NIPS has become more common, selective terminations involving genetic conditions have too. Some studies have shown that parents often decide to terminate a pregnancy, even after finding a mild form of a genetic condition, including Turner and Klinefelter syndromes.

Down syndrome is the most common chromosomal disorder in the U.S., and about 6,000 babies are born with it in the U.S. each year, according to the Centers for Disease Control and Prevention.

A published review of studies, which included 24 publications studying pregnancy terminations after a prenatal diagnosis of Down syndrome in the U.S., found that 67% ofthose pregnancies end in abortion.

Terminating a pregnancy after the 2nd trimester because of medical complications

Its notable, however, that the majority of abortions in the U.S.(91%) occur at or before 13 weeks of gestation. Abortions late in pregnancy are rare,butMalhotra said some of the main reasons why they do happen include delays and other barriers in obtaining abortion care, or after discovering medical complications. Those complications often include the discovery of lethal fetal anomalies, which can be detected during a fetal anatomy scan that is usually performed at around 20 weeks of pregnancy. Terminations at this stage, Malhotra said, are difficult and traumatic, because these pregnancies are often desired.

It's really tragic, as you're telling these patients who have been continuing their pregnancy. They're at 20 weeks. They're excited about the pregnancy. They're planning their baby showers. They come to that ultrasound hoping to be able to find out the sex of the baby and you tell them this devastating news, that there is an abnormality that is either not compatible with life, or is going to have significant impact on the quality of life after birth, the Ohio doctor said.

Malhotra told Yahoo News that Ohios new abortion law has made her job even tougher, because she also has to tell patients in these situations who wish to terminate the pregnancy that they cannot receive such care in their state.

It is just horrible, because not only are you giving them this tragic, heartbreaking news, but you're stigmatizing their care, because you're saying, Oh, this thing is illegal here, but you could go to another state. So they have to travel to another state to do something that's illegal, which is a part of medical care, Malhotra said. If they're not able to go out of the state, then we're asking them to take on risks associated with a pregnancy, which we know inherently, pregnancy is not risk-free.

In addition, she explained, she needs to inform these patients that they must act rapidly. Abortions later in a pregnancy are more complex and also more expensive. Medication abortion, which can be taken at home, can only be safely used in the first 70 days, or 10 weeks of pregnancy. After that, women need a surgical abortion, which typically takes about two days and requires inpatient care. A patient who needs to go out of state to receive care must therefore also take into account additional costs related to travel and lodging.

Because of the abortion bans that have gone into effect in the Midwest, surrounding states where the procedure is protected have seen an increase in patients, Malhotra said. They are really backed up, currently complicating the scheduling of an abortion, she said.

Another important reason to act quickly in these situations, according to Malhotra, is because most states do not permit abortions after 24 weeks when a fetus has reached viability and can survive outside the uterus. According to the Guttmacher Institute, a research group focused on reproductive health, 17 states impose a ban at viability.

Little research has been conducted on what happens to women who are unable to terminate a pregnancy because of a fetal genetic condition or anomaly. However, one study conducted by the University of California, San Francisco, that tracked 1,000 women unable to get an abortion because they had passed the gestational limits, found they were more likely to fall into poverty, as well as have worse financial, health and family outcomes, than those who had terminated their pregnancies.

Opponents of abortions conducted as a result of screening for disabilities believe that such procedures are unjust, because all human beings have inherent value from the moment of conception. Malhotra, on the other hand, told Yahoo News that she finds it absolutely horrible to put patients in a position where they dont have a choice anymore.

There are multiple reasons women may choose to terminate a pregnancy because of a genetic condition or anomaly, ranging from the emotional and financial cost of raising a disabled child to the effect that this may have on the existing children in a family, as well as the feeling that it is cruel to give birth to a child who may need a lifetime of constant medical intervention.

Connors said that terminations due to genetic or fetal anomalies are comparatively rare, but are often emphasized unduly in conversations on abortion and abortion care. It inadvertently leads to a narrative about what makes a good or a bad abortion, he said.

Sagaser agreed, saying:There's no benefit to us as a society to say, Oh, there's this one population that really needs access to abortion care more so than other people.'

Everyone deserves to be able to make the choices that are right for them and their family in that unique situation, she added.

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Restrictive abortion laws are limiting the options parents have after receiving genetic test results, experts say - Yahoo Singapore News

Article In Brief

Neurologists who see patients with neurologic conditions who are pregnant, or who are considering pregnancy, said the Supreme Court decision to reverse Roe v. Wade, the right to an abortion, interferes with their ability to provide informed decisions about health care for their patients.

Neurologists who care for patients who are pregnant, or who are planning pregnancies, are facing new discussions about clinical care in the wake of the Supreme Court's June 24 Dobbs v. Jackson Women's Health Organization decision to reverse the historic Roe V. Wade 50-year precedent to legalize abortion.

Neurologists have a critical window into how the reversal of Roe will impact patients with neurologic disease. Neurologic health is inextricably linked with reproductive health, said Sara LaHue, MD, a neurohospitalist and assistant professor of clinical neurology at the University of California, San Francisco.

...Bans on abortion will immediately affect the delivery of current standard neurologic care for many patients, specifically standards that depend on planning or preventing pregnancies using individual choice, Dr. LaHue and colleagues wrote in a viewpoint on the impact of the Dobbs decision on neurology in the July 13 issue of JAMA Neurology article.

I dare say that there are very few specialties within neurology that don't have some connection to how reproductive health influences the health of our patients, said Diana Cejas, MD, MPH, a child neurologist who specializes in autism spectrum disorders, intellectual disabilities, and neurodevelopmental disabilities.

As a pediatric neurologist, I talk about these issues with my patients all the time: the risks of certain medications to a developing fetus, the need to be on birth control, what it would mean for them if they got pregnant. There are all kinds of implications for reproductive health that we are involved with as neurologists. We have patients with significant illnesses and chronic disability within neurology, for whom pregnancy could be devastating if not life-threatening. This decision is absolutely going to affect our patients' health and the way we practice.

Many neurologic conditions that commonly affect women in their reproductive years, including epilepsy, migraine, multiple sclerosis, myasthenia gravis, and brain tumors, are often managed with medications that are known to be teratogenic, with many more lacking clear evidence about their teratogenicity.

As an epileptologist, I see many patients who are on antiseizure medications known to be teratogenic, such as valproic acid, said Ima Ebong, MD, an assistant professor of neurology at the University of Kentucky.

We have conversations about reproductive health and what the consequences of these medications can be, weighing the pros and cons of treating your epilepsy and the protections you need to put in place for yourself and potentially a pregnancy, including barrier contraception, hormonal contraception, and having the ability to abort a pregnancy if necessary. Not every patient wants to use contraception, even though we recommend it; none of the methods are 100 percent effective, and many antiseizure medications lower the efficacy of contraceptives, so it is unavoidable that some people will become pregnant while on these medications. With the reversal of Roe, in some states women no longer have the ability to make these decisions for themselves, and I think it's inevitable that we will see increases in serious birth defects as a result.

Similarly, both the National Multiple Sclerosis Society and the Food and Drug Administration recommend discontinuing the use of most disease-modifying therapies (DMTs) for multiple sclerosis while trying to conceive, during pregnancy, or breastfeeding.

Glatiramer acetate and interferon beta are thought to be the safest of the DMTs, so if a woman wants to get pregnant with active disease, in rare situations a neurologist might leave a woman on one of those therapies, but they are modestly effective compared to the highly effective newer agents, said Amy Hessler, DO, FAAN, who recently left her position as director of women's neurology at the University of Kentucky to establish a women's neurology clinic in Jacksonville, FL.

Teriflunomide is the worst oneif accidental pregnancy occurs while on this agent, the medication is immediately stopped and a rapid elimination procedure is required urgently, as well as counseling [for] the mother about the increased risk of teratogenicity. Dimethyl fumarate should be stopped at the same time the woman stops contraception, due to uncertain but potential risks. Fingolimod is also associated with increased risk of adverse fetal outcomes. There are pregnancy registries associated with all these medications to make the best treatment decisions. Also, there is risk to the woman of rebound relapse if she is rapidly taken off her MS medication, particularly with fingolimod and natalizumab. It can be hard to get it back under control and it can even be life-threatening.

If one of our patients were to become pregnant while on any of these medications that can cause severe teratogenic effects, there are currently no options for them in Texas, said Audrey Nath, MD, PhD, a pediatric epileptologist and clinical assistant professor of neurology at the University of Texas Medical Branch in Galveston.

Concerns about legal restrictions or even prosecution for the use of these medications in a patient's reproductive years could potentially lead neurologists to be restrictive in their prescribing of appropriate therapies, Dr. LaHue and coauthors suggested in the JAMA Neurology article.

In a climate of increased limitations on reproductive rights, whereby pregnancies cannot be reliably timed or prevented, neurologists might possibly restrict use of the effective medications that are standard care for other patient groups because of potential concerns about causing fetal harm, they wrote. This could increase risk of morbidity, mortality, and irreversible disability accumulation for women with neurologic diseases.

Attempts to restrict the use of such medications even when prescribed by a physician have already been reported in states that have banned abortion. Methotrexate, a folate antagonist that can cause miscarriage at high doses and is the preferred treatment for ectopic pregnancy, is also one of the most used drugs for the treatment of inflammatory conditions such as rheumatoid arthritis, lupus, psoriasis and psoriatic arthritis, and Crohn's disease. It is sometimes used off label for the treatment of multiple sclerosis and as a less expensive, steroid-sparing agent for the treatment of myasthenia gravis.

But the cases that keep Dr. Nath up at night are those pertaining to children and teenage girls she has cared for with intellectual disabilities caused by neurodevelopmental conditions. These conditions may be due to a genetic disorder that affects brain development, brain injury earlier in life, or childhood seizure disorders that can affect cognition, she said.

It's well known that young women with intellectual disabilities are at higher risk for unplanned and unwanted pregnancy, Dr. Nath said. They are more likely to be targeted for sexual assault, they may be easier to manipulate because of their intellectual disability and find themselves in situations that they can't handle, and they are at high risk for becoming pregnant because they may not take birth control reliably or even be aware of their menstrual cycles.

They may not even realize they are pregnant, she added. The entire pregnancy and delivery process can be very traumatic for someone with an intellectual disability who may be functioning at a level much below their actual age, and young girls like this are a very high-risk population for pregnancy and delivery.

Women with a family history of neurogenetic disorders, ranging from neurofibromatosis to Fabry disease, Canavan disease, and Tay-Sachs disease are likely to be denied the option to make decisions about their pregnancy depending on the state they live in, said Janet F. Waters, MD, FAAN, clinical associate professor of neurology and division chief for women's neurology at the University of Pittsburgh Medical Center. Previously, these women could undergo testing during pregnancy and make a choice as to whether to continue if the child would be born with these significant and sometimes fatal neurologic diseases, but now they will not have the option.

Sonika Agarwal, MBBS, MD, previously practiced maternal fetal medicine in India and now specializes in fetal and neonatal neurology at the Children's Hospital of Philadelphia of the University of Pennsylvania.

Our role as pediatric neurologists should extend to women's health care before, during, and between pregnancies to maximize both the woman's health and the neonatal outcome which impacts pediatric health, Dr. Agarwal said. This ruling takes away both the patient's autonomy and the primacy of the physician-patient relationship. The only way we can render safe, effective, and evidence-based care in what are often profoundly challenging situations is to come together as a team of medical experts, critically evaluate all testinggenetics, imaging scans for the fetal brain and other systemsand any complications in the pregnant woman's health and go through the complex process of counseling a pregnant woman/couple about the likely prognosis and outcomes.

For example, she continued, in cases of anencephaly, we know the baby is not going to survive. There are other neurologic conditions where the baby may survive but would face significant challenges around birth and need lifelong support due to a severe and complex brain malformation or extensive brain destruction by stroke or brain bleed; we can reasonably say they will have a profoundly impaired neurological function or quality of life, or a reduced lifespan where they will live only for a few years sustaining on life support with feeding and breathing tubes. In these challenging fetal neurologic consultations, the clinicians and the parents together weigh all the information about the quality of life and possible outcomes for the unborn baby and the medical team supports them in the decision-making process. This critical relationship between patient and medical professionals is not something that should be intruded on by legislators.

Abortion bans also limit clinicians' options for managing women who develop life-threatening problems during pregnancy, said Mary Angela O'Neal, MD, FAAN, division chief of general neurology at Brigham and Women's Hospital in Boston and an expert in the neurology of pregnancy.

I've had patients diagnosed with brain cancer in pregnancy, and the treatment for mom is not something that's going to be good for the babysurgery, radiation, chemotherapy or all three. This is a very difficult choice for families to make, but it should be theirs. Or when a woman develops pre-eclampsia, that can cause stroke, hemorrhage, and death, and the only treatment is delivery. Will induction of labor in circumstances like these, such as in the late second trimester when the baby is unlikely to survive, be allowed under some of these state laws?

No one seems to know for sure, as many of these laws are vague and choices about enforcement are left up to local and state officials. In Ohio, for example, state law says that abortion is permitted only in a medical emergency requiring the immediate performance or inducement of an abortion to prevent death or irreversible bodily harm that delay in the performance or inducement of the abortion would create.

With such vague, open-to-interpretation language, how do clinicians decide just how immediate the medical emergency is? If states write laws that are completely vague about what the requirements are, they can still have abortion on the books, but have an environment in which no physician is willing to provide it, Melissa Murray, a law professor at New York University, told opinion writer Michelle Goldberg in a July 14 article in the New York Times.

Dr. Waters is haunted by the case of a woman who was brought to Magee-Womens Hospital at about 21 weeks of pregnancy in flagrant eclampsia like no case I have seen before. She had hidden her pregnancy from a strict family and sought no prenatal care; her pregnancy was diagnosed only after she came to the hospital with seizures and was given a routine pregnancy test prior to undergoing a head CT.

By the time she reached us, this woman was blind, she had so much brain edema that she was essentially comatose. We had to save the mom and save her fast, said Dr. Waters. We had to go through basically a delivery at 21 weeks, which would be considered an abortion under many of these laws. The baby was already gone, but what if it had still been alive? In a state with an abortion ban, what choice do you make? In any decision about delivery, the woman has to come first.

Although abortion remains legal and likely to be protected in 19 states, women in large swaths of the country will have to travel long distances to access an abortion, which poses a significant problem of equity.

Here in Kentucky, our trigger ban was enjoined by a court, but if it goes into place, leaving the state is not realistic for the average person, said Dr. Ebong. Kentucky is a very poor state, and the nearest states are West Virginia, Tennessee, and Ohio, which are in the same boat as Kentucky when it comes to their laws. Women can't just get a plane ticket to go further for an abortion, that's not a realistic option and it shouldn't have to be. You should have access close to where you are.

Individuals who have more resources are going to have more choices, agreed Dr. O'Neal. This will affect lower-income people more devastatingly because they're not going to have the financial and other resources to be able to make those choices. We know that people from marginalized communities have less opportunity to have neurologic care to plan and optimize their medications, so they are at even more risk. Their choices are being taken away from them as we speak, and I can't see this as doing anything but magnifying the already existing inequities.

These laws are directly in conflict with our code of ethics as neurologists and as physicians, which is to put our patient's best interest first, said Dr. Cejas. We won't be able to provide appropriate care. Regardless of what a person thinks about abortion from an ideological perspective, abortion is health care, and it is a medical procedure, and we have to offer our patients multiple options with respect to their care. But as more of these restrictions come into place, we'll see more and more neurologists put into positions where taking the best care of our patients from a medical and ethical perspective is in conflict with what we are allowed to do from a legal perspective. When I talk to colleagues in states with these bans already in place, they don't know what to do and what to tell their patients. And what will our hospitals do to protect us and our right to provide optimal care?

The AAN, Association of American Medical Colleges, the American Medical Association, the American Academy of Pediatrics, the American Psychiatric Association, the American Epilepsy Society, as well as the Child Neurology Foundation and Child Neurology Society, have all published statements in response to the Supreme Court decision, focusing on the primacy of the relationship between physicians and their patients in making health care decisions.

Dr. Nath urges neurologists to make their voices heard by becoming more involved in advocacy. When we have our voices heard in the rooms where they are writing legislation, that can have a very big impact, particularly within state legislatures, she said. This is one among many issues that shows us that we need to have a seat at the table. It's a wakeup call for us. It matters who's in these legislatures, and your professional and life experience matters.

In this issue, we cover the impact of the recent Supreme Court decision overturning Roe vs. Wade on the field of neurology. The editors of Neurology Today believe that abortion is health care, and health care decisions should be made between patients and their physicians. We fear for the impact on the health of women with neurologic disorders, who may find themselves in life-threatening situations due to this decision. We will continue to cover the impact of the Supreme Court decision on our patients and our practice.

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Neurologists Discuss the Impact of Roe v. Wade Reversal on... : Neurology Today - LWW Journals

The U.S. Supreme Court on June 24 overturned Roe v. Wade, the 1973 decision that had provided a constitutional right to abortion. The ruling was expected to lead to abortion bans in roughly half the states, although the timing of those laws taking effect varies.

Some Republican-led states banned or severely limited abortion immediately after the Dobbs v. Jackson decision, while other restrictions will take effect later.

In anticipation of the decision, several states led by Democrats took steps to protect abortion access. The decision also set up the potential for legal fights between the states over whether providers and those who help women obtain abortions can be sued or prosecuted.

Here is an overview of the impact the ruling has had so far in every state and the status of their laws.

ALABAMA

Political control: Alabamas Republican-controlled Legislature and Republican governor want to ban or restrict access to abortions.

Whats happened since Dobbs: Hours after the Dobbs ruling, a judge lifted an order that had blocked a 2019 law with one of the nations most stringent abortion bans from being enforced.

Whats in effect: The ban is now in effect. It makes it a felony to perform an abortion at any stage of pregnancy with no exceptions for rape or incest. There is an exception in cases where the womans health is at serious risk. The penalty is up to 99 years in prison.

Clinics offering abortions? No.

Whats next: Some Republican lawmakers have said they would like to see the state replace the 2019 ban with a slightly less stringent bill that would allow exceptions in cases of rape or incest. Proponents said the 2019 ban was deliberately strict in the hopes of sparking a court challenge to Roe.

ALASKA

Political control: Republicans hold a majority of seats in the Legislature, but the House has a bipartisan coalition majority composed largely of Democrats. Republican Gov. Mike Dunleavy, who believes life begins at conception, is seeking reelection. His main challengers independent former Gov. Bill Walker, and Democrat Les Gara have said they would protect abortion rights if elected.

Whats happened since Dobbs: The Legislature ended its regular session before the decision came out, and there has been no push for a special session.

Whats in effect: The state Supreme Court has interpreted the right to privacy in the state constitution as encompassing abortion rights.

Clinics offering abortions? Yes.

Whats next: Voters in the fall will be asked if they want to hold a constitutional convention, a question that comes up every 10 years. Many conservatives who want to overhaul how judges are selected and do away with the interpretation that the constitutions right to privacy clause allows for abortion rights see an opportunity in pushing for a convention.

ARIZONA

Political control: The GOP controls both chambers of the state Legislature. Republican Gov. Doug Ducey must leave office in January because of term limits.

Whats happened since Dobbs: Legal uncertainty about two different abortion laws prompted clinics to stop providing the procedure. Republican Attorney General Mark Brnovich has asked a judge to lift a decades-old order that blocks enforcement of an abortion ban passed before Arizona was a state. But a new law scheduled to take effect Sept. 24 would be less stringent, banning abortions after 15 weeks of pregnancy. Also after the Dobbs ruling, the U.S. Supreme Court began allowing the state to enforce a 2021 ban on abortions done solely because the fetus has a genetic abnormality such as Down syndrome. But a federal judge in Phoenix in July blocked enforcement of another part of that so-called personhood law that grants legal rights to fertilized eggs or fetuses. Abortion rights supporters said that could have been used to charge providers with assault, child abuse or other crimes for otherwise-legal abortions.

Whats in effect: The law before Dobbs barred abortions after about 22 weeks.

Clinics offering abortions? No.

Whats next: More court battles are expected over whether the earlier, more complete ban is in effect and whether Arizonas less stringent law can take effect in September.

ARKANSAS

Political control: The Legislature and governors office are controlled by Republicans. Gov. Asa Hutchinson is term-limited and will leave office in January. Republican nominee Sarah Sanders, press secretary to former President Donald Trump, is widely favored to succeed him in the November election.

Whats happened since Dobbs: A trigger ban on most abortions adopted in 2019 went into effect.

Whats in effect: Abortions are banned with the exception of when the procedure is needed to protect the life of the mother in a medical emergency.

Clinics offering abortions? No.

Whats next: Hutchinson favors exceptions in the case of pregnancies caused by rape or incest, but he does not expect to ask lawmakers to consider it at a special legislative session.

CALIFORNIA

Political control: Democrats who support access to abortion control all statewide elected offices and have large majorities in the Legislature.

Whats happened since Dobbs: The day of the Dobbs ruling, Gov. Gavin Newsome signed a bill intended to protect patients or providers from being sued in states that have abortion bans. He has also launched a commitment with Oregon and Washington to defend access to abortion.

Whats in effect: Abortion is legal in California until viability, generally considered to be around 24 weeks.

Clinics offering abortion? Yes.

Whats next: Lawmakers plan to put a constitutional amendment on the ballot in November that would explicitly guarantee the right to an abortion and contraceptives.

COLORADO

Political Control: Colorados Democratic-controlled Legislature adopted and its Democratic governor signed into law a fundamental right to abortions in April.

Whats happened since Dobbs: After the legislature introduced the bill codifying abortion rights, Colorado Governor Jared Polis signed an executive order saying Coloradans will not participate in out-of-state abortion-related investigations.

Whats in effect: Colorados Reproductive Health Equity Act declares fundamental rights to abortions at any stage of pregnancy. The law also prohibits local governments from denying, restricting, or depriving individuals of an abortion. State law still prohibits public funding for abortions and requires that minors inform their parents.

Clinics offering abortions? Yes.

Whats next: Republican lawmakers in Colorado have spoken about legislative challenges to the new state law. Colorado clinics are gearing up for an expected wave of out-of-state abortion seekers as surrounding states pass abortion bans.

CONNECTICUT

Political control: Democrats who control the Connecticut General Assembly support access to abortion, as does the states Democratic governor.

Whats happened since Dobbs: A law protecting abortion providers from other states bans took effect July 1. It created a legal cause of action for providers and others sued in another state, enabling them to recover certain legal costs. It also limits the governors discretion to extradite someone accused of performing an abortion, as well as participation by Connecticut courts and agencies in those lawsuits.

Whats in effect: Abortion is legal in Connecticut until viability, generally considered to be around 24 weeks. A law adopted in 2022 allows advanced practice registered nurses, nurse-midwives or physician assistants to perform aspiration abortions in the first 12 weeks of pregnancy.

Clinics offering abortions? Yes.

Whats next: Theres been discussion of amending the state constitution to enshrine the right to abortion, which could take many years.

DELAWARE

Political control: Democrats control the governors office and the General Assembly and have taken several steps to ensure access to abortion.

Whats happened since Dobbs: The state already had a 2017 law to codify the right to abortion and a 2022 law allowing physician assistants and advanced practiced registered nurses to prescribe abortion-inducing medications. After the ruling, the state adopted another law allowing physician assistants, certified nurse practitioners and nurse midwives to perform abortions before viability that includes legal protections for providers and patients.

Whats in effect: Abortion is legal until viability.

Clinics offering abortions? Yes.

Whats next: With protections in place, no major abortion policy changes are expected.

DISTRICT OF COLUMBIA

Political control: The local government in the nations capital is controlled by Democrats, with a Democratic mayor and the D.C. Council split between Democrats and nominal independent politicians, who are all, invariably, Democrats.

Whats happened since Dobbs: No policy changes have come about since the ruling.

Whats in effect: Abortion is legal at all stages of pregnancy.

Clinics offering abortions? Yes.

Whats next: The D.C. Council is considering legislation that would declare Washington, D.C., a sanctuary city for those coming from states where abortion is banned. But because Congress has oversight power over D.C. laws, a future ban or restrictions remain possible depending on control of Congress.

FLORIDA

Political control: Republicans control the House and Senate and governors office, with GOP Gov. Ron DeSantis pledging to expand pro-life protections after the Dobbs decision.

Whats happened since Dobbs: Floridas new 15-week abortion ban law went into effect July 1. The law is the subject of an ongoing lawsuit from abortion providers in Florida but remains in effect.

Whats in effect: The Florida law prohibits abortions after 15 weeks, with exceptions if the procedure is necessary to save the pregnant womans life, prevent serious injury or if the fetus has a fatal abnormality. It does not allow exceptions in cases where pregnancies were caused by rape, incest or human trafficking. Violators could face up to five years in prison. Physicians and other medical professionals could lose their licenses and face administrative fines of $10,000 for each violation.

Clinics offering abortions? Yes.

Whats next: The lawsuit against Floridas 15 week ban is ongoing and is expected to eventually reach the state Supreme Court. Republicans believe the conservative-controlled court will uphold the law.

GEORGIA

Political control: Georgia has a GOP-controlled General Assembly and a Republican governor who support abortion restrictions, but all are up for election this November.

Whats happened since Dobbs: A federal appeals court allowed the states 2019 abortion law to be enforced in a July 20 ruling after three years of being on hold.

Whats in effect: The law bans abortion when fetal cardiac activity can be detected and also declares a fetus a person for purposes including income tax deductions and child support. There are exceptions in cases of rape if a police report is filed and incest. There are exceptions if a womans life or health would be threatened.

Clinics offering abortions? No.

Whats next: Some Republican lawmakers and candidates want Georgia to go further and ban abortion entirely, but Gov. Brian Kemp is unlikely to call a special session before Novembers general election. Lawmakers are likely to consider further action when they return for their annual session in January. A major factor is whether Kemp is reelected or unseated by Democrat Stacey Abrams in Novembers election.

HAWAII

Political control: Hawaiis governor is a Democrat and Democrats control more than 90% of the seats in the state House and Senate.

Whats happened since Dobbs: The law hasnt changed.

Whats in effect: Hawaii legalized abortion in 1970, three years before Roe v. Wade. The state allows abortion until a fetus would be viable outside the womb. After that, its legal if a patients life or health is in danger.

Clinics offering abortions? Yes.

Whats next: Democratic lawmakers are considering how they might protect Hawaii medical workers from prosecution or civil litigation from other states for treating residents who arent full-time Hawaii residents such as military dependents or college students. Policymakers are paying attention to how the state may increase access to abortion on more rural islands where there is a doctor shortage, for example by boosting training for some nurses who under a new law passed last year are allowed to perform first-trimester abortions.

IDAHO

Political control: Republicans hold supermajorities in the House and Senate and oppose access to abortion, as does the states Republican governor.

Whats happened since Dobbs: The ruling triggered a ban on all abortions except in cases of reported rape or incest or to protect the mothers life. It is to take effect Aug. 25. President Joe Biden's administration has sued over the measure, arguing that it conflicts with a federal law requiring doctors to provide pregnant women with medically necessary treatment.

Whats in effect: Current law allows abortions up to viability, around 24 weeks, with exceptions to protect the womans life or in case of nonviable fetuses.

Clinics offering abortions? Yes.

Whats next: The Idaho Supreme Court is expected to rule in August on whether to lift an injunction that blocked enforcement of a law that could subject medical providers who perform abortions to lawsuits and criminal charges.

ILLINOIS

Political control: Illinois is overwhelmingly Democratic with laws providing greater access to abortion than most states. Democrats hold veto-proof supermajorities in the House and Senate, and the Democratic first-term governor seeking reelection this year, J.B. Pritzker, has promoted peaceful protests to protect the right to an abortion.

Whats happened since Dobbs: No major policy changes. Pritzker has called for a special legislative session to expand abortion rights.

Whats in effect: Abortion is legal in Illinois to the point of viability, and later to protect the patients life or health.

Clinics offering abortions? Yes.

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Abortion ruling prompts variety of reactions from states - ABC News

1) After repeated attempts, which are also cost-consuming, many couples opt out of in-vitro fertilisation (IVF) treatments, losing their hope for pregnancy. Can pregnancy be successful after multiple failed IVF attempts?

An IVF cycle can fail because of a few reasons Improper diagnosis of the cause of infertility, improper treatment, chromosomal abnormalities in embryo and failure of implantation/endometrial receptivity. One of the first things that IVF requires is that both the male and female partners go through a few tests, including blood tests and ultrasound, to determine the root cause of infertility. It is only after a thorough investigation of each unique patient case that a treatment can be charted out. In many cases, the couple is required to take up medication to treat underlying health conditions or even other procedures such as removal of uterine fibroids.

Once fertilisation of the egg and sperm takes place and an embryo is formed, pre-implantation genetic testing (or PGT) is performed to check for any genetic anomalies in the embryo; these anomalies can act as a barrier to conception or lead to miscarriage. Thus, PGT helps in two waysa) transfer of the best graded embryo into the uterus, and b) single embryo transfer (multiple embryo transfers can be done in some cases to increase the probability of pregnancy but can lead to complications later). The technology used including minute details such as the temperature and humidity at which gametes are handled can also make a significant difference to the success of an IVF cycle. In most cases, the gap is bridged by understanding the history of the patient, taking a unique approach to the case and choosing the right technology.

2) You had a patient who got pregnant after the 14th attempt. Can you share details?

After repeated cycles of failed in-vitro fertilisation (IVF), Nashik couple Vibha and Abhik (names changed) were successful with a twin pregnancy on their 15th attempt. Married for 15 years, the couple exhibited secondary infertility since they already had an elder child. Hoping to complete their family with more children, they tried to conceive naturally as well as using assisted reproductive technology (ART). Then they opted for IVF.

Vibha (36) reported having chronic hypertension and hypothyroidism. Upon testing for fertility parameters, it was found that the uterine lining, endometrium, had grown into the uterus (called adenomyosis). Additionally, the left fallopian tube was blocked with fluids (left terminal hydrosalpinx) and had less number of viable eggs (poor antral follicular count). On analysing Abhiks semen sample, it was found that he had severe oligoasthenoteratozoospermia or OAT. This condition is marked by three characteristic defects in sperm low sperm count, poor sperm movement and abnormal shape.

The couple had attempted ART 12 times with their own eggs, all of which failed. Given the couples compromised levels of healthy egg reserve and sperm, the best alternative was to opt for donor embryos. Donor embryos are genetically and physically healthy and have better chances of implanting in the uterus, and subsequently leading to a live birth.

In order to prepare Vibhas uterus for implantation, she was given platelet-rich plasma (PRP) 10 days before embryo transfer. Laser assisted hatching also helped to prepare her womb. Two donor embryos were transferred. Levels of human chorionic gonadotropin (hCG) and an ultrasound confirmed the presence of two growing foetuses. But they didnt last full term. This is called recurrent implantation failure. This is a complex problem that occurs due to a number of reasons. The treatment plan varies, depending on the source of the problem. In such cases, the best solution that provides light at the end of the tunnel is personalised treatment, depending on the unique nature of each case.

3) What is the success rate of IVF per cycle according to the age of the couples?

Age has a variety of effects on fertility in general and the efficacy of IVF. According to the Centres for Disease Control and Prevention (CDC), the average percentages of ART cycles that lead to a live birth are: 31 per cent in women younger than 35 years of age 24 per cent in women aged 35 to 37 16 per cent in women aged 38 to 40 8 per cent in women aged 41 to 44 3 per cent in women age 43 and older

These success rates have historically been associated with the biological clock of women and their limited reproductive window. However, new studies on the relation of age and male infertility have found that men, too, have a similar limitation. Men above the age of 40 have been found to have deteriorated sperm quality and reduced fertility.

4) It has been observed that even young couples in the age group of 25 and 35 face infertility and are now opting for IVF treatment. What are the reasons behind early infertility?

Young couples in their mid-20s and 30s are increasingly having difficulty conceiving. This can be attributed to the emergence of lifestyle-related diseases such as diabetes, obesity, hypertension, and thyroid disease. Other lifestyle triggers are work-related stress at work, poor eating habits, increase in consumption of alcohol and tobacco and lack of regular exercise. The pandemic-induced lockdowns and work-from-home formats have meant long sedentary hours, which have upset the hormone patterns of young people. Medical conditions such as endometriosis, endometrial tuberculosis and polycystic ovarian syndrome (PCOS) are also to blame.

It is, however, imperative to mention that there is an increased awareness about infertility. The easy access to information on IVF and an openness to accept a medical solution to infertility have played a significant part in changing mindsets. This is also applicable for people who are born with genetic diseases or congenital limitations.

5) What kind of fertility issues are most common among younger couples nowadays?

There has been a spike in cases among couples experiencing infertility wherein women have been diagnosed with polycystic ovarian syndrome (PCOS) and men with azoospermia. It has also been noted that in many young men experiencing infertility, exposure of the pelvic area to continuous heat (such as laptops or engines) has been a contributor. It is known that the testes need to be a few degrees cooler than the rest of the body. This exposure to heat sources impacts sperm production.

Moreover, with six per cent of the adult Indian population living with one or more sexually transmitted diseases (STDs) that can impact reproductive organs and function, it is essential that those with multiple sexual partners get regular STD tests done so that they can be treated early enough. In women, other fertility health issues can include endometriosis, pelvic inflammatory disease and uterine fibroids. In men, other fertility challenges can include erectile dysfunction, retrograde ejaculation and varicoceles.

6. Considering the changing lifestyle of todays young generation, what suggestions do you have for those who want to marry late?

You must get married or begin a family only when you feel prepared to do so. For young people, especially in urban centres, it has become increasingly common for both partners to become financially independent first before committing to a family. Those who envision having a family in the future can plan their fertility journey ahead in time.

With the help of cryopreservation techniques, they can freeze their eggs and sperm in their 20s to early 30s and use them up to 10 years later when they are ready to get married and/or to start a family. Even for young couples, who are married but would want to focus on their careers or explore the world before bringing in a new life, embryo freezing is a technique that can help them conceive later. This ensures that eggs, sperms and embryos are harvested at a time when they are genetically and morphologically robust.

Additionally, young individuals must also take care of their health to avoid complications. The simple things that one can do is to incorporate a balanced diet, be physically active, maintain a healthy weight, avoid consumption of alcohol and tobacco, take proactive measures to combat stress and anxiety and go for regular health check-ups.

7. Is there a right age for IVF?

Even with technology, age continues to be a major determinant of pregnancy outcomes. Women in their 20s and early 30s, who use IVF, have more chances with pregnancies and single live births. However, after reaching the mid-30s, the success rates begin to drop slowly. Ageing eggs are unable to fertilise with a sperm or have genetic anomalies, reducing chances of a full-term baby. At the age of 30, women have about 12 per cent of the 300,000 eggs that they are born with. By the age of 40, only 9,000 of them remain. As soon as women reach the age of menopause (50-55), there are very less eggs remaining in the ovary and their viability is questionable. Patients are recommended to seek eggs from younger egg donors once they reach the age of 43.

As per the Assisted Reproductive Technology (Regulation) Act, 2021, men and women need to be between the legal age of marriage and 55 respectively to seek treatment. This is essential as conceiving at an older age may also lead to several other complications for both the mother and baby.

Regardless of seeking the entire process of IVF, young couples as well as single men and women have the choice to freeze their sperms and eggs, respectively. This ensures that these gametes are collected early on in their lives and can be utilised when they are ready to have children in the future.

(Why this doctor? Dr Kshitiz Murdia has a fellowship in infertility from Singapore. He has experience of performing more than 15,000 IVF cases)

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Is pregnancy possible after multiple failed IVF attempts? Can your frozen eggs and sperm be as healthy later? - The Indian Express

Hospital Healthcare Europe had the pleasure of speaking with Professor of Orthopaedic Surgery, Javad Parvizi MD FRCS, who shared his thoughts on recently published international consensus meeting recommendations on venous thromboembolism and how they could impact clinical care

Please tell us about your background and institution?

Dr Parvizi originally trained for four years to be cardiovascular surgeon before moving to the US to undertake research on blood flow based in an orthopaedics laboratory. He later took up a residency in orthopaedics at the Mayo Clinic before finally moving to Philadelphia, where he has been since 2003. The Rothman Institute is part of Thomas Jefferson University and one of the largest orthopaedic practices in the world, employing over 300 physicians and surgeons. According to Dr Parvizi, this busy department performs approximately 20,000 joint replacements every year.

What exactly is a DVT and how common is it?

As Dr Parvizi explained, a DVT is a deep vein thrombosis and is a clotting problem that occurs in peoples veins and blocks the vein. He added that sometimes a clot in the lungs can stop people from breathing, leading to a fatal outcome. As he continued, both a DVT and pulmonary embolism or collectively, a venous thromboembolism (VTE), are potentially life-threatening conditions if not treated or prevented.

Dr Parvizi discussed how most VTEs happen after surgical procedures but a VTE can be an unprovoked occurrence, for instance, through air travel, sitting for a long period of time or even out of the blue. Although there is always a risk of developing a DVT after a surgical procedure, Dr Parvizi added that current thinking suggested that some patients have a genetic predisposition to develop a VTE.

How high is the risk of developing a VTE among surgical patients?

According to Dr Parvizi, the risk of developing a VTE after an orthopaedic procedure (even when accounting for other risk factors) is variable. There are two types of VTE: one below the knee (a distal DVT); and a proximal DVT, which occurs above the knee, and which is associated with a greater risk to a patient. Dr Parvizi felt that distal DVTs are common, suggesting that these can occur in 10% 15% of cases after a joint replacement but, fortunately, as he explained, these are all self-limiting, non-significant events. In fact, Dr Parvizi noted how in many cases, both clinicians and patients would be unaware that a DVT occurred and that distal DVTs invariably resolve over time. Nevertheless, the development of a pulmonary embolism (PE) is a much more serious complication, but thankfully the rate at which these develop is much lower. Dr Parvizi estimated that a PE might occur at a rate of perhaps 0.5% or even lower, although the rate of a fatal PE is even lower, perhaps 1 in 1000, although the literature suggests that the actual incidence might be lower still, at 1 in 4000.

What is the patient burden of a VTE?

In most cases where a patient develops a distal DVT after surgery, Dr Parvizi described this as a benign event that commonly resolves without any lasting problems. In contrast, a chronic VTE is more problematic and could lead to postphlebitic syndrome, where there is a blockage of the veins in the legs. As he explained, postphlebitic syndrome can result in chronic swelling, and chronic ulcerations for a patient. However, he ventured that perhaps the most important reason to assess whether a patient had a DVT was to prevent the formation of a PE. Although there is a widely held belief in the mechanical propagation theory, i.e., where a DVT literally travels from distal veins to the pulmonary circulation, Dr Parvizi said that recent work has questioned this theory and that now we think that a DVT doesnt really travel to the lungs but that a PE and DVT can develop at the same time, in a patient who is in a hypercoagulable state.

What about the healthcare and economic burden of chronic DVT?

Dr Parvizi explained how the economic impact of a chronic DVT is significant, as patients require long-term treatment, which might include hospitalisation as well as chronic use of anticoagulants. As he explained, a DVT is more likely to become chronic if a patient develops several DVTs during their procedure or when they become unresponsive to anticoagulation, and this latter effect can arise if an individual has an underlying problem with the anatomy of the veins.

Why do you think that the new guidelines were necessary?

Dr Parvizi explained how surgery induces a hypercoagulable state and which, in turn, increases the risk for the development of VTE. In the past after joint replacement, patients usually stayed in bed for a prolonged period of time. As a result, he added during the 1970s and 80s, the rates of DVT and PE were very high. In recent years, with a shift towards outpatient surgery and implementation of rapid recovery protocols, the overall incidence of VTE has declined drastically. Nevertheless, one practice from the past that has continued is the post-operative use of aggressive anticoagulation and Dr Parvizi discussed how in recent years, given the change in surgical practice and advice to avoid prolonged bed rest, the value of such aggressive anticoagulation has been called into question. A further consideration which might reduce the need for anticoagulation is greater use of intermittent compression devices. According to Dr Parvizi, due to a major shift in the delivery of care, there is now less requirement for aggressive anticoagulation. However, an important driver for change is the attendant risk associated with the use of anticoagulants, which lead to bleeding, increasing the risk for a haematoma, gross bleeding into the surgical wound or even in other organs such as the brain. Additionally, anticoagulants are both expensive and can be inconvenient to the patient, given the need for healthcare professionals to administer and/or monitor the anticoagulation drugs. Furthermore, anticoagulants are not benign drugs, and their use is associated with several other problems that include the need for re-hospitalisation, re-operation, infection and joint stiffness. In fact, Dr Parvizi noted how there have been studies showing that aggressive anticoagulation can kill patients, just like fatal PE.

Dr Parvizi acknowledged that while there are current guidelines available to help surgeons, these are subject to several limitations. For instance, most relate to hip and knee replacement and do not specifically cover other orthopedic procedures such as spine, foot and ankle, and sports surgery.In addition, Dr Parvizi mentioned how the current guidelines are totally disparate and conflicting in nature, with some recommending either for or against aggressive anticoagulation. A further limitation was that the current guidelines do not take into account the genetic or geographic predisposition for formation of VTE. As Dr Parvizi explained, For example, Asian patients are at a much lower risk of developing VTE than Caucasians. A final constraint of the currently available guidelines is that these were outdated, relating to surgical protocols that are not in effect any more, or limited themselves to reviewing literature that was mostly conducted by industry, which of course introduces some degree of bias.

Given all of the limitations, the International Consensus Meeting (ICM) gathered over 500 experts and specialists from across the world to produce updated and global guidelines using a strict and well defined process. The guideline committee reviewed the current literature, formulated relevant questions for current practice and sought consensus on these questions. Ultimately, the finished product was designed to be a global guideline for the prevention of VTE after all orthopaedic procedures.

A further advantage of the new guideline was the inclusion of physicians from other medical disciplines, such as cardiology, haematology, anaesthesia, vascular medicine and others, which enhanced the value of the guidelines and made them more applicable.

What would you say are the overarching principles and key recommendations of the guideline?

Dr Parvizi felt that the overarching principle of the guideline was the prevention and management of VTE for all orthopaedic procedures. He explained how the guideline was divided up into ten parts, one of which was a general section, with each of the subsequent sections being related to the different sub-specialities, e.g., foot and ankle, spine, etc.

The general recommendations were designed to answer questions relevant to all patients who underwent an orthopaedic surgical procedure. A total of 200 questions/issues were covered that included questions such as, are there genetic predispositions that cause VTE? or does prolonged bed rest increase the incidence of VTE? with the answer being yes to both questions.

Dr Parvizi felt that the most important recommendations were the following. Administration of aggressive anticoagulation is not necessary for the majority of patients undergoing orthopaedic procedures. He added that there is now plenty of evidence to show that intermittent compression devices work very well to prevent VTE but also that they provide additional benefits such as a reduction in post-surgical swelling of extremities, offer a better range of motion for the knee, and are associated with better patient satisfaction compared with the use of aggressive anticoagulation.

One overarching conclusion of the guideline, stemming from the available literature, is that low-dose aspirin is cost-effective and a safe modality for prevention of VTE. Studies have shown tha the use of aspirin also reduces post-operative fever, which is a common event that worries the patients and healthcare professionals. Moreover, Dr Parvizi mentioned that the use of aspirin has also been to reduce the rate of extra bone formation in the soft tissues (heterotopic ossification) and stiffness after orthopaedic procedures. He explained how the guideline recommended that aspirin should preferably be given twice a day for a period of four weeks but even two weeks of aspirin appears to be enough for most of these patients.

Overall, Dr Parvizi thinks that the new guidelines will allow clinicians to move away from the use of aggressive anticoagulants and to make greater use of intermittent compression devices and aspirin. In fact, he believes that the use of aggressive anticoagulants should now be reserved for those patients with a genetic predisposition and/or patients an extremely high risk for a VTE.

How will these guidelines impact clinical practice?

Dr Parvizi mentioned how in the US there has been a general shift over the last few years away from the use of aggressive anticoagulation towards the use of aspirin and intermittent compression devices. In fact, he quoted data from a survey of over 3000 joint surgeons showing that over 90% of surgeons now use compression devices and/or aspirin for prevention of VTE after joint replacement. While there has been an important change in practice among US surgeons, he thought that adoption of aspirin and intermittent compression devices by surgeons from other parts of the world has been slow mostly due to medico-legal concerns. A further barrier to adoption of aspirin and intermittent compression devices has been the resistance of colleagues from other specialties, such as haematology and cardiology, who might not be aware of the wealth of orthopaedic literature endorsing the use of aspirin.

He hopes that the publication of the new guidelines will provide the necessary endorsement and reassurance to the medical community to embrace a change in practice.

Are there any remaining uncertainties that might be addressed in the future?

Dr Parvizi felt that one of the benefits of developing a new guideline was that while providing robust evidence to support a change in orthopaedic practice, it also highlighted gaps in the current evidence and enabled the formulation of relevant questions that should be addressed by future research. He believes that there is a need for independent studies to compare the efficacy of low-dose aspirin with other anticoagulation agents. He mentioned one current, ongoing study (PEPPER trial) that is comparing low-dose aspirin, coumadin and factor 10 inhibitors for VTE prevention, the results of which are eagerly awaited. He noted how more studies are required to better understand the genetic mutations that predispose individuals towards having a VTE as well as more work on the role of intermittent compression devices.

Taken together, Dr Parvizi hoped that future studies will facilitate a move away from the use of expensive anticoagulants which ultimately have a huge economic impact. For example, he described how in the US alone there are over one million joint replacement procedures undertaken per year so if 92% of those patients are receiving aspirin, the anticipated cost savings would run into hundreds of millions.

Furthermore, there are a whole range of additional benefits to using aspirin including a reduction in the development of haematomas, infection risk, post-operative fever and subsequent clinical, fever work-up, less need for transfusions and a lower level of post-operative anaemia. He added that the available data suggest that aspirin is actually better than coumadin for the prevention of VTE. Ultimately, he suggested that convenience, efficacy, safety and economic benefits of aspirin are just beyond dispute now and that, over time, there will be a shift towards the use of aspirin and intermittent compression devices instead of expensive anticoagulant medications.

As for the next steps, Dr Parvizi says that the combination of the publication of the guideline in a prestigious orthopaedic journal (Journal of Bone and Joint Surgery) and future translations of the documents into numerous languages will allow effective dissemination of the work that was generated by over 500 experts. The guidelines are being discussed at various conferences and have been endorsed by a number of professional organisations, publishing the guideline on their websites. Finally, Dr Parvizi believes that it is necessary that patients who require orthopaedic procedures should no longer fear the development of a blood clot and become better informed that the changes in surgical procedures and VTE management in recent years are designed to be safer and more convenient for them.

Recommendations from the ICM-VTE: General. The ICM-VTE General Delegates. J Bone Joint Surg 2022;104(suppl 1):4162.

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Meet the Expert: Focus on orthopaedics and VTE - Hospital Healthcare Europe

There are a number of reasons you might consider donating your eggs. For some, the choice is monetary, as you may be well-compensated for your donation. For others, its the act of helping a couple have a baby. And it can certainly be both.

Whatever your motivation, the egg donation process is relatively straightforward and takes place over a 2-month period, according to the Center for Reproductive Health & Gynecology. Once you pass the initial application and legal hurdles, youll use medications to prepare your eggs for the egg procedure.

Keep reading to learn more about the egg donation process, including the possible risks and some tips for ways to prepare yourself before, during, and after the procedure.

Egg donation involves a donor who provides eggs to a recipient for the purpose of getting pregnant. Sometimes this recipient is the intended parent, and other times, it may be a surrogate who will carry a pregnancy for the intended parents.

A 2017 study showed that typically, between 5 to 24 eggs will be retrieved per cycle. The number of eggs retrieved is based on how many you produce and any specific guidelines the clinic follows.

Compensation for egg donation varies by area and fertility clinic. ConceiveAbilities, which has offices across the United States, shares that donor compensation begins at $8,000 per donation. This amount can go up based on various factors specific to each clinic.

The egg donor will receive various injectable medications throughout their menstrual cycle. These medications stimulate your ovaries to produce multiple eggs. Specific medications may include:

First, you will receive a dose of human chorionic gonadotropin (hCG), which is sometimes called a trigger shot. A doctor will remove the eggs in a procedure called egg retrieval. This is performed using a special needle attached to a transvaginal ultrasound device. The needle is passed through your vaginal wall and into your ovary. The eggs are suctioned (aspirated) out and sent to an embryologist for evaluation before fertilization.

Here is a step-by-step overview of the entire process:

Next, the eggs can either be frozen or mixed together with the intended fathers sperm to create embryos. The embryos are then transferred and implanted into the uterus of the birth parent or surrogate.

Yes. Egg donation when closely supervised by a medical professional is generally a safe process and does not carry any long-term health risks. This includes fertility issues, provided you dont develop complications.

A 2015 research review showed that most young adult females have around 400,000 eggs. So, taking even up to 24 eggs per donation cycle for several cycles will leave many to spare for the future.

However, there are some short-term risks to be aware of during the donation cycle. These risks include:

Its not easy to predict the discomfort you may experience before, during, and after the retrieval process. Many factors may contribute to pain, including your personal tolerance level, your bodys reaction to the different medications, as well as any complications you may experience.

Symptoms you may have after the egg retrieval include:

The good news is that you can expect your discomfort to improve as soon as the day or a few days after the retrieval procedure.

Your doctor will advise you about over-the-counter (OTC) medications you can take for pain, such as acetaminophen or ibuprofen. A heating pad may also help ease abdominal discomfort.

If you develop a fever, heavy bleeding, or any other symptoms of infection, call your doctor as soon as possible.

Preparing your body for egg donation is similar to preparing your body for the in vitro fertilization process. First, youll want to take good care of yourself by following a healthy lifestyle.

Fertility clinics, like the CNY Fertility Center, recommend paying special attention to the following areas for 3 months before retrieval for the best quality eggs:

Its also a good idea to create a support network for yourself. Egg donation can be challenging both physically and emotionally, so having trusted friends or family members nearby can help. Your support network can also help if you need transportation to and from appointments or any other assistance during the process.

Above all else: Ask questions. A 2020 survey of egg donors revealed that 55 percent of women did not feel they were well educated on the long-term risks of donation. Your doctor or fertility clinic can give you specific advice and resources to both understand and lower your risk of complications.

There are both state and federal regulations surrounding egg donation. Specifics vary depending on your state, so be sure to check with your clinic for any specific information that applies where you live.

Children born through egg donation are not considered your legal children, despite their genetic relation to you. The intended parent is listed as the guardian on any legal documents, like the birth certificate.

These details should be clearly stated in any contracts that you sign before the physical process begins. Working with lawyers to come up with an egg donation legal agreement can help protect you and ensure youll be fairly compensated.

Areas covered by the egg donation contract may include:

Be sure to ask yourself how much (if any) involvement you would want after your donation. Your rights are protected once you sign your agreement. And as the donor, you should have your own attorney. Tulip Fertility says that this does not come as a cost to you. Instead, the intended parents should cover these fees.

The egg donation process involves various physical, emotional, and potentially legal challenges. Along with doing your own research, reach out to a local fertility clinic for more specifics about your location and your personal situation.

Theres a lot to consider, but donating your eggs can be incredibly rewarding and financially empowering. Once you understand the risks and rewards, you can make the right choice for yourself and your future.

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Egg Donation Process: From Application to Recovery - Healthline