By T. Grim. California State University, Monterey.

Savage sets out the medical sequelae of Caesarean section in terms which make it clear that judicial interventions to enforce Caesareans on unwilling women put the patient at far greater risk order 120mgmg sildalist with mastercard. From then until 1998 best 120mgmg sildalist, English law cheap sildalist 120 mg online, although based on this basic misunderstanding, moved closer and closer to overturning the traditional common law doctrine that the fetus is not a legal person (Scott, 2000). In the process, the Mental Health Act 1983 was also used to enforce Caesarean sections, although section 63 of that statute makes it clear that it must only be used to sanction forcible treatment for a mental 4 D. Savage also brieXy considers the opposite situation, in which the woman requests a Caesarean section which the doctor opposes on the grounds that it is not clinically indicated and will increase the patient’s level of risk. Women, Daniels argues, are seen as solely to blame for subsequent harm to fetuses, disregarding the documented connection be- tween paternal exposures to toxins and fetal health. Male reproduction is construed in terms of virility, female in terms of vulnerability – with the exception of women of colour, who loom large in the American public debate about ‘abusive’ crack mothers. Bewley, who is lead clinician in maternal–fetal medicine at St Thomas’s Hospital, London, faces similar dilemmas to those which concern Savage – how far should a feminist obstetrician go in impos- ing treatment on women in the name of their own best interest, and/or that of the fetus? Bewley is willing to recognize the interests of the fetus to a greater, more pragmatic extent – or more correctly, to recognize the uniqueness of the maternal–fetal relationship, without necessarily assuming, in a naturalis- tic manner, that this uniqueness carries moral weight. Bewley maintains that the regulation of women who have chosen to maintain their pregnancy is also Introduction 5 adiVerent question from the abortion debate. The concepts which have evolved in the abortion literature are not really relevant to the clinician’s dilemma in dealing with a drug-using pregnant patient. In attempting to develop a conceptual framework which Wts this particular clinical situation, Bewley draws on Frankfurt’s distinction between Wrst- and second-order desires (Frankfurt, 1971). Bewley’s article is a model for what this book tries to achieve – the marriage of analytical and clinical arguments, put forward by a philosophi- cally and legally aware clinician. The British medical lawyer Jean McHale (Chapter 6) likewise considers the manner in which ‘pregnancy over the last decade has become policed by those who advocate responsible motherhood’. As more widespread genetic information becomes available, she warns, ‘it is likely to render us increasing- ly critical of those who make what we regard as being the ‘‘wrong’’ decision in relation to reproduction’. McHale is sceptical of this argument, suggesting that codes of practice stressing parental duties not to reproduce unless the oVspring meet certain criteria are really just rationing tools. The argument that it is unfair for society to bear the ‘costs’ of the couple’s penchant for reproduction, if their children are likely to be handi- capped, meets with no friendlier reception from her. Pressing on beyond these politically motivated arguments, McHale asks whether there could conceivably be any remedy in law for enforcing a ‘right not to be born’. In a previous book, Breaking the Abortion Deadlock: From Choice to Consent (1996), McDonagh sought to unite opponents and proponents of abortion behind an argument justifying abortion not in terms of the woman’s right to choose, but of her consent to further continuation of the pregnancy. Conceding fetal personhood in ar- guendo, as most pro-choice activists do not, McDonagh argued that even if the fetus were a person, its claims would not necessarily ‘trump’ the mother’s right to withhold consent to continuing the pregnancy and giving birth. Dickenson again breaks down the barriers between feminist and antifeminist arguments: ‘The problem of abortion has been deWned by pro-life activists (as we would expect), but also by pro-choice advocates (as we might not expect) on the basis of a very traditional model of motherhood, one invoking cultural and ethical depictions of women as maternal, self-sacriWcing nurturers’. That is, by stressing the way in which unwanted pregnancy forces women into the stereotype of sacriWcial victims, the model of motherhood used by pro- abortion campaigners is actually deeply conservative, and possibly counter- productive. McDonagh’s chapter, like Daniels’s, takes this section of the book out of the conWnes of the dyadic doctor–patient relationship and into the political arena. By contrast, Franc¸oise Baylis and Susan Sherwin (Chapter 18) extend the political power dimension into a very familiar and ‘ordinary’ side of the obstetrician–patient encounter – ‘non-compliance’. Baylis and Sherwin draw our attention to the way in which this apparently value-free term is used to reinforce the physician’s power and to label the patient as an object of concern rather than a partner in the clinical relationship. In some instances, however, failure to follow professional recommendations elicits pejorative judgements of non-compliance, and while these judgements are provoked by a failure to comply with speciWc advice, typically they are applied to the patient as a whole’. By alerting the conscientious practitioner to the ubiquitous presence of ethical issues, Baylis and Sherwin help to counteract the popular media assumption that the only serious questions in reproductive ethics are those about new technologies. The impact of new technologies and new diseases The questions asked by McHale about limiting the rhetoric of responsible parenting recur in a more technology-driven form in the chapter by the American philosopher and feminist theorist Rosemarie Tong (Chapter 5). Likewise, the aims of medicine may conceivably be extended from doing no harm to this particular mother and fetus to producing the best babies possible. As Tong remarks, physicians are unable to resist patient demands for genetic enhancement because there is no Introduction 7 generally agreed set of aims of medicine with which to counter such demands – ‘Medicine, it has been argued, is simply a set of techniques and tools that can be used to attain whatever ends people have; and physicians and other health care practitioners are simply technicians who exist to please their customers or clients, and to take from them whatever they can aVord to pay’. Unless doctors are content to play this passive role, it is essential that they should think through the ethical issues surrounding new technologies and the increased demands to which they give rise. They are also mixed blessings when, while provid- ing a means to desired motherhood for some, they occasion pressures on others to undergo risks they would not otherwise encounter’. Higher-order pregnancies, as a form of iatrogenic harm occasioned by misapplication of fertility technologies, are the particular focus of Mahowald’s attention. This distinction is not merely semantic Wnickiness – ‘fetal reduction’ obscures the fact that some fetuses are being aborted, and yet even a ‘pro-lifer’ might 8 D. Can selective termination ever be justiWed, or is allowing ‘targeting’ of a particular fetus on grounds of sex, for example, simply wrong whether that sex is male or female?

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Therefore 120 mg sildalist fast delivery, the largest amount of missing information concerns the role played by lawyers and judges buy sildalist 120mg on line, such as statement by counsel cheap 120mgmg sildalist otc, opening statement by the prosecution, cross-examinations and judges’ summing up, which were habitually excluded. Despite the abridgments, the Old Bailey Proceedings website represents an invaluable historical corpus that facilitates both The Old-Bailey Proceedings: Medical Discourse in Criminal Cases 237 diachronic socio-linguistic and socio-pragmatic research. Although this study will not take a diachronic perspective, but will conduct a synchronic analysis of expert witness narratives and discursive th strategies in trials in the early 20 century, trials and expert witness testimonies undoubtedly represent a good example of spoken language data from earlier periods and moreover provide an invaluable source of information on the participants’ age, sex, status, culture, and their relationship in a specific context and setting which would not otherwise be available. This seems to be one of the major obstacles that historical pragmatics has to face: knowledge of the spoken interaction of the past is only confined to what can be gleaned from written records (Culpeper/Kytö 2000). In considering the value of the Old Bailey Proceedings as a source of historical data, it is important to remember that even if they “do not provide a full transcript of everything that was said in court”, as the website itself states, the materials reported can be considered accurate and their reliability has often been confirmed by other manuscripts or published records which can be checked using multiple sources or a ‘triangulation’ procedure, as suggested by Culpeper and Kytö (2010). Additionally, it can be presumed that the trials under scrutiny here, occurring in a period between 1902 and 1913, were very likely to have undergone a comparison with other reports or alternative accounts before publication. As Culpeper and Kytö (2000: 188) explain, many trial proceedings were designed for general public consumption and “sometimes part of the marketing strategy was to claim, usually in the title page, that the proceeding was a ‘true’ or ‘faithful’ record taken in court”. The same authors later state that the important factor in this kind of historical research is that “the historical speech report purports to be a faithful report” (Culpeper/Kytö 2010: 81). The inquiry will focus on the managing of specific medical lexis and phraseology (such as, for 238 Michela Giordano example, the expressions a separate existence, puerperal fever and transitory mania) and their embedding in the legal context of which the particular setting and situation call for explanations and clarifications of meanings unknown to the lay jury, the lawyers and the judge himself as well as most of the people present in the courtroom. Medical experts in the historical courtroom The present chapter analyses the position and the discourse of medical experts in the historical courtroom: the adjective historical here carries multiple meanings. The first and more straightforward one is that which alludes to the old period being considered, in this case the decade 1902-1913, more than a century ago. The second meaning points to the distinction between the salient features of early courtrooms and the present-day ones and looks at what insights present-day courtroom linguistic studies can gain from the investigations of early or historical courtroom discourse. More precisely, the expression historical courtroom is utilised by authors such as Kryk-Kastovky (2000, 2006), Jucker (2008) and Chaemsaithong (2011), who see the courtroom of earlier periods as the site from which examples of original spoken language of the past can be derived. Following this, the historical linguist or pragmatist is confronted with the question of how the written data available nowadays actually reflects the language spoken in that given historical period, in order to understand the “conventions of language use in communities that once existed and are no longer accessible for direct observation” (Archer 2005: 6). However, the same author reports that, already in 1554, a judge declared, The Old-Bailey Proceedings: Medical Discourse in Criminal Cases 239 If matters arise in our law which concern other sciences or faculties we com- monly apply for the aid of that science or faculty, which it concerns. For thereby it appears that we don’t despise all other sciences but our own, but we approve of them and encourage them, as things worthy of recommendation. Historically, experts could in fact participate as specialist jurors whose particular knowledge was gained from their personal experience and th th training. In the late 13 and 14 centuries, such specialist juries were generally composed of goldsmiths, aldermen, cooks, fishmongers and masters of grammar who used their specialized knowledge to render their verdict (Chaemsaithong 2011). Towards the early modern period, there began a constant and continual decline in the use of a knowledgeable and informed jury that was entrusted with a “fact- finding, investigatory role” (Stygall 2001: 331). It was gradually replaced with a silent and uninformed jury whose responsibility was merely to consider evidence and testimony from the other witnesses in a trial. Thus, expert witnesses became necessary to give specialised testimony and evidence that would better inform the jury about the case before pronouncing their verdict (Chaemsaithong 2011). Since they had personally observed the facts and testified as to their conclusions, they could express their opinions; yet these were not differentiated from those of lay jurors who could do exactly the same, basing themselves on their direct knowledge of the facts of the case (Golan 2003). Furthermore, what must be borne in mind is that the growth of expert knowledge in fields such as medicine and its recognition as such is a relatively recent phenomenon, dating back to about the end th of the 19 century. This was of course the result of the growing reliance on science and the simultaneous rise of university and mass education systems that helped to legitimize the privileged status of 240 Michela Giordano experts, resulting from their professional expertise, capability and competence (Chaemsaithong 2011). However, as still happens in the modern adversarial court, expert witnesses in the historical courtroom needed to construct and negotiate their identity, especially during the cross-examination when they were obliged “to counterbalance sceptical attitudes and hostile attempts aimed to undermine their testimony that accompanied their vulnerable status and image” (Chaemsaithong 2011: 472). An analysis of their discursive practices could also help shed light on the means they adopted to gain control during the interaction and (re)negotiate and (re)affirm their identity and professionalism. Analysis and discussion The defendants in the fourteen trials under investigation were all un- married women, aged 18-29 who worked as tailoresses, laundresses or domestic servants who were all accused of infanticide generally following an illegitimate pregnancy. Most of them were judged guilty and condemned to imprisonment or hard labour; some received the death penalty, and some were considered unfit to plead because of their (presumed) insanity. As can be seen from Table 3, the medical experts were generally medical superintendents, or assistant medical officers, registered medical practitioners, divisional surgeons of the police, or pathologists. Despite their titles and qualifications, as stated above, medical experts in the historical courtroom had to negotiate their professional identity and their expertise. Experts were not always allowed to expand on their answers or provide further explanations of medical evidence for the benefit of the jurors and the judge. The medical narratives in direct examinations are generally longer than in the other examinations and this can be explained by its less challenging and taxing nature. Medical jargon embedded in the legal context From a thorough reading of the transcripts, the use of two particular phrases comes immediately to the reader’s attention: separate exis- tence, referred to the newly-born baby and puerperal fever, referred to the mother. As will be explained later through the selected excerpts, the experts in the trials in the corpus appear to have had the opportunity to provide clarifications and details about the meaning of the two expressions and this can be explained by what Chaemsaithong (2011) states about expansions of response. In their answers to the lawyers’ questions, they were able to provide detailed information and to expand their replies, often adding explanations of the most difficult medical terminology or of the expressions which needed to be clarified for the lay jury and the public present in the courtroom or even for the legal professionals who had no knowledge of or even familiarity with certain scientific and medical facts. Additionally, Chaemsaithong (2011: 480) notes that, differently from lay witnesses, experts in historical courtrooms were there to convey their opinion about a particular issue based on their qualifications and thus The Old-Bailey Proceedings: Medical Discourse in Criminal Cases 243 attempted to shield themselves from blame and criticism. The expansion of responses had several communicative goals for medical experts: a) to establish their identity as experts; b) to negotiate positive self-representation and prevent their already vulnerable status from being attacked; c) to propagate and reproduce the scientific ideology.

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The purpose of the study initi- Of primary importance to the investigator is the ation meeting is to orientate the study staff to the rationale for use of the drug and the expected safety requirements of the protocol order sildalist 120mg mastercard. The protocol should be explained buy sildalist 120mgmg free shipping, must ensure that the study medication and mater- including the requirements for the patient popula- ials are available at the site generic sildalist 120 mg visa. To be a successful monitor, the sponsor repre- sentative should know: how to interpret hospital/ subinvestigator(s), the study coordinator or re- clinic records/charts, laboratory tests, and inter- search nurse, pharmacist, and laboratory personnel pretations; has to query resolution procedures; or specialists as needed. Procedures for subject enrollment are addition, a monitor needs to have excellent inter- particularly important, since this is the area which personal communication and problem-solving may cause the most problems for the site. Conducting Clinical Trial Monitoring Clinical trial monitoring includes those activities The frequency of clinical monitoring depends on that ensure that the study is being conducted the actual accrual rate of the patients. Monitoring permits an studies may need to be visited more frequently, in-process assessment of the quality of the data depending on the accrual rate of subjects, the being collected. Monitors Following a monitoring visit, the monitor will ensure that the study is conducted, recorded and prepare a monitoring report for sponsor records reported in accordance with the protocol. The monitor reconciles investigational Local affiliate name Expiry date product shipped, dispensed and returned; arranges for shipment of investigational product to core country or investigative sites; checks investiga- supplies are being kept under the required storage tional product supplies at site against enrollment conditions. Failure to do so can result product inventory problems; implements tracking in some of the data having to be discarded during system for investigational product management on statistical analysis. This issue can prove to be prob- a study and project level; arranges for the return lematic when a single site is studying patients at and/or destruction of unused investigational prod- different locations. Finally, the double-blind code uct supplies; and ensures final reconciliation of must not be broken, except when essential for the investigational product supplies. Drug packaging should follow as consistent a Management of safety is a principal responsibil- format as possible within a project and must be ity of the sponsor monitor. Regulatory docu- sponsibility for informing the investigator about ments required for investigational drug use in the the safety requirements of the study. Drug supplies should be rec- changes from baseline with expected pharmaco- onciled and the integrity of the double-blind logical effects, acute and chronic effects and mul- treatment codes should be confirmed. In multicenter about the event to headquarters within 24 h and trials, a single lead investigator may sign a pooled headquarters will get the information to the drug study report. Presents the detailed efficacy the annual report must be written in a clear, concise findings, including the intent-to-treat analysis manner that accurately summarizes and interprets population and the efficacy data listings. Presents the detailed safety find- vide clear, simple graphs, tables, and figures to ings, including the intent-to-treat analysis illustrate and support safety findings. What is needed to get a drug Fourth, the chapters on Phase I clinical trials and approved is not the same as what is needed to make pharmacoeconomic research have been written by that drug into a commercial success. The typical pharmaceutical velopment, how this is done, and what preclinical physician has usually paid little attention to these information is needed in order to carry it out. Pharmaceutical physicians, spe- view regulatory affairs as the implementation of cialized though they may be in one discipline or their clinical development plans (and probably another, are well-advised to keep an observant eye vice versa), the proper constraints imposed by regu- on the interactions between their own and other latory authorities are so fundamental that they de- company departments. From the cellular stage, the re- searcher next defines specific molecular targets, An outline of the thought processes involved in such as receptors or cellular enzymes that comprise designing and implementing a Drug Discovery pro- the destructive phenotype. This chapter Researchers will target systems which are will discuss the process, and give practical examples affected by, or may be directly involved with, a from contemporary drug discovery scenarios. The treatments arising from All drug discovery projects depend on luck to these types of approaches can be palliative, or be successful, but research and careful planning can may find a market or need as disease-modifying improve chances of success and lower the cost. Prime examples of palliative therapies are Project teams can streamline the discovery process drugs designed to alleviate side effects of treatment by mapping the most direct methods that will yield with toxic chemotherapeutic drugs, such as nausea a discovery. In these cases, drug discovery scien- biology, chemistry, robotics, and computer simula- tists search for drugs which alleviate each symptom tions, years can be eliminated from the search for as if it were an isolated pathology. The costs of getting a new therapeutic Disease-modifying drugs are those which directly into the marketplace in 1997 were estimated at affect the primary disease. In many cases, prelimin- from a particular receptor in normal cells, but are ary research has been published on several aspects mutated, and thus are constitutively active or con- of the pathology. Is there an anomaly in a cell derived from a ations in the cellular architecture required for tumor, to use a cancer example, which renders that mitosis (cytoskeleton and cell motility). Unless a company can work faster or Hypothetically, because we also know that ster- better than the competition by taking a direct ap- oids, a currently used therapeutic, works by inhib- proach, it is, perhaps, a better strategy to approach ition of gene expression of many of these mediators, the target identification issue less directly. Are the transcription mechanisms known, seek to inhibit transcription factor activation by and if so, are there any other required enzymes or phosphorylation or proteolysis, while another proteins which are regulated by those same mech- group seeks to inhibit the binding of the transcrip- anisms? The real work comes in families with patterns of hereditary disease, and sequencing and identifying these genes, and ascer- mapping the transmission of the disease to find taining which are the unknown, novel sequences. The are then used in functional assays to prevent a Human Genome Project is a consortium of govern- response thought to be critical for disease develop- ment and industry-funded laboratories, which se- ment. Genomics and New Target Identification At the time of writing complete genomic se- quences are available for atleast 141 viruses, 51 Drug companies have recently become involved in organelles, two eubacteria, one eukaryote and the use of genomics to identify new genes which most mammalian mitochondria.

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