Love v. Superior Court (People)
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AIDS Serodiagnosis↗
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When is cloning lawful?
The infertility (Medical Procedures) Act (Victoria) is the first legislation in the common-law world designed to regulate the practice of in vitro fertilization. This act explicitly prohibits "cloning," without providing a definition of this term. The legislative history of the act suggests that it refers only to the production of multiple, identical copies of human individuals. But other scientific procedures, for which cloning is also a correct scientific term, may unintentionally be banned. The act should be amended in order to remove doubts about the position of molecular biologists, cytologists, and cytogeneticists, whose work may involve the production of "clones" of human cells and/or human genes in vitro.
Advisory Committees↗
On cestodes of Passer domesticus I. Choanotaenia, Raillietine and Proparuterina.
An investigation on the cestode fauna of the common sparrow, Passer domesticus (Linnaeus) was carried out for about five years. In all 445 birds were examined during this period and only five species of cestodes were found to parasitize this bird: of these, three are known while two are new forms, the latter are the rarities. This part includes critical accounts of Choanotaenia passerina (Fuhrmann, 1907), Raillietine (R.) galeritae (Skrjabin, 1915) and Proparuterina lali sp. nov. - Choanotaenia passerina (Fuhrmann, 1907) has been previously studied by Fuhrmann (1907), Johnston (1909), Stunkard & Milford (1937) and Kintner (1938). The present study provides additional data. The writers find two rows of rostellar hooks in the present material. Fuhrmann and Johnston reported two rows of rostellar hooks, but Kintner apparently found a single row of rostellar hooks. Variations have been found in the number of testes and extent of cirrus sac. Amongst the previous workers, only Johnston (1909) paid attention to study the protective coverings present around the hexacanth and described two envelopes, but the writers find three. - Raillietine (R.) galeritae (Skrjabin, 1915) has been restudied and redescribed from fresh material. Previously Mahon (1958) studied this species from P. domesticus. The present account includes important variations and some additions too. Suckers have been found to be armed in contradiction to what Mahon stated. Gravid proglottides have been found to develop a velum. Egg capsules contain 3-13 eggs each. Two protective envelopes have been found around the hexacanth. This is the first record of the occurrence of this species in P. domesticus in India. Proparuterina lali sp. nov. is a rare parasite of Passer domesticus. Only one more species viz. P. aruensis Fuhrmann, 1911 is known. The present species differs from P. aruensis in the number and distribution of testes, bilobed nature and median position of ovary, position of vitellarium and of genital pore. The generic diagnosis of Proparuterina Fuhrmann, 1911 has been amended in the light of the morphology of the present species.
Animals↗
Unexpected acute neurologic toxicity in the treatment of children with acute lymphoblastic leukemia.
BACKGROUND: Our current protocol for treatment of childhood acute lymphoblastic leukemia (ALL) was designed to assess the efficacy of methotrexate (MTX) plus L-asparaginase and of etopisode (VP-16) plus cytarabine (ARA-C) during intensive consolidation and continuation therapies and to determine the feasibility of intensifying MTX therapy by the use of divided oral doses of MTX. The protocol was associated with unexpected acute neurotoxicity. There are few reports of such toxic effects during therapy for ALL. PURPOSE: This report describes these toxic effects and outlines our successful approach to the problem. METHODS: The standard four-drug induction regimen consisted of vincristine, L-asparaginase, daunorubicin, and prednisone. In consolidation therapy, oral MTX was given in divided doses (dMTX) of 25 mg/m2 every 6 hours four times daily in four weekly courses concomitant with weekly triple intrathecal therapy--MTX, ARA-C, and hydrocortisone--plus one dose of leucovorin 24 hours after triple intrathecal therapy. Consolidation treatment ended with three daily doses of intravenous VP-16 and ARA-C. The first 16 months of continuation therapy included 6-week cycles of dMTX and L-asparaginase, both given every other week for 5 weeks, with 6-mercaptopurine nightly, and then two doses of VP-16 plus ARA-C and one dose of triple intrathecal therapy. RESULTS: Twenty-five of the 138 patients evaluated had acute neurotoxicity. Ten of the first 72 experienced a seizure or episode of transient neurological deficit 9-11 days following the administration of intravenous ARA-C, VP-16, and triple intrathecal therapy. Despite discontinuation of intrathecal ARA-C, which eliminated simultaneous intravenous and intrathecal treatment with ARA-C, acute neurotoxicity was observed in six previously unaffected patients and six of 42 patients treated after the elimination of intrathecal ARA-C. Therefore, as a second amendment, oral leucovorin was given 24 and 36 hours after dMTX and intrathecal MTX in continuation therapy. No acute neurotoxicity has been seen in 24 patients subsequently entered in the study. CONCLUSION: These findings suggest that folate replacement due to administration of leucovorin modulated MTX toxicity and/or modified an interaction among VP-16, ARA-C, intrathecal therapy, and the central nervous system.
Adolescent↗
Driving with epilepsy: a contemporary perspective.
A committee of concerned neurologists in cooperation with the Tennessee Department of Safety and other agencies reviewed the present state licensing rules for epileptics and offered recommendations for amendments. Epileptics, diabetics, and patients with cerebrovascular disease have an accident rate of approximately twice that of the general population. Seizures probably account for approximately .02% of all vehicle accidents and only .5% to .01% of the fatal accidents. Accidents caused by seizures involve the driver's vehicle alone or an immovable object 80% of the time and occur in less populated and developed areas than controls. The number of seizures within the first three months of therapy is a powerful prognostic indicator. With knowledgeable individual consideration, licensing epileptics to drive could be done much earlier than previously allowed, without affecting road safety. Physicians giving recommendations for licensing in good faith should be protected by law from liability for unforeseen seizure recurrence.
Accidents, Traffic↗
Errors by the American Psychiatric Association, the American Psychological Association, and the National Educational, Association in representing homosexuality in amicus briefs about Amendment 2 to the U.S. Supreme Court.
In October 1995, consortiums of psychiatric and educational profes sional organizations, including the American Psychological Association and the American Psychiatric Association and the National Educational Association, submitted amicus briefs to the U.S. Supreme Court asserting that the scientific literature unequivocally supports the following propositions (a) that homosexuals, including homosexual teachers, do not disproportionately molest children, (b) that children of homosexual patients are not more likely to become homosexuals, (c) that professionals agree that homosexuality is not a pathology, and (d) that homosexual attractions are biologically or genetically predetermined and are therefore beyond the control of the individual. The first two contentions are inconsistent with the scientific literature, and the second two grossly oversimplify a contentious and uncertain literature.
Adult↗
Predicting faecal indicator fluxes using digital land use data in the UK's sentinel Water Framework Directive catchment: the Ribble study.
The Ribble drainage basin is the single UK sentinel study area chosen for examining the implementation of the EU Water Framework Directive (WFD 20/60/EC). The study which has generated the data for this paper was initiated to quantify 'catchment-derived' fluxes of faecal indicators originating from both point and diffuse sources to inform the competent authorities on the potential for, and prioritization of, further options for reducing the faecal indicator loadings to this crucial coastal environment. It represents the first UK drainage basin-scale 'profile' of faecal indicator sources as recommended by WHO [1999. Health Based Monitoring of Recreational Waters: The Feasibility of a New Approach; the "Annapolis Protocol". World Health Organisation Geneva, Switzerland; 2003. Guidelines for Safe Recreational-Water Environments Volume 1: Coastal and Fresh-Waters. World Health Organisation Geneva, Switzerland] and incorporated into current drafts of the revised Bathing Water Directive [Anon, 2004. Council of the European Communities Amended proposal for a Directive of the European Parliament and of the Council concerning the management of bathing water quality. Brussels 23rd June]. This paper focuses on the relationships between land use and faecal indicator organism concentrations in surface waters within this very large drainage basin (1583 km2) containing some extensive urban areas. A geographical information system comprising readily available digital elevation, remotely sensed land cover and digital map data was used to generate the land use variables for subcatchments draining to 41 locations across the study area. Presumptive concentrations of coliforms, Escherichia coli and enterococci (colony forming unit (cfu) 100 ml(-1)) were measured at each location on at least 20 occasions over a 44-day period within the 2002 bathing season. The sampling programme targeted hydrograph events. Hydrometric records were used to allocate results as either base flow or high flow. At each site, geometric mean faecal indicator organism concentrations were significantly elevated at high flow compared to base flow. Stepwise regression modelling produced statistically significant models predicting geometric mean base and high-flow faecal indicator organism concentrations from land use variables (r2: 49.5-68.1%). The dominant predictor variable in each case was the proportion of built-up land in subcatchments, suggesting that this land use type, with associated sewage-related inputs, is a critical source of faecal indicator organisms in this drainage basin.
Biomarkers↗
[Evaluation of a checklist for anesthetic equipment before use].
OBJECTIVE: To describe and to assess the use of a checklist for anaesthetic equipment, the effects on the quality of care, as well as the difficulty to obtain a complete and permanent compliance of anaesthesia staff to the use of the checklist, in comparison with the practice patterns in other countries and of the recommendations by the French society of anaesthesia and intensive care for the anaesthetic machine checking. STUDY DESIGN: Prospective quality assurance study with two subsequent phases. METHODS: Both a detailed and a simplified checklist were initially tested over a 57-day-period to evaluate the incidence and severity of recognized abnormalities and to assess the compliance of the staff with this new procedure. Four months later, the same evaluation was performed again. The detailed checklist was used before the first anaesthetic in the morning and called "Theater opening form". The simplified list was used before the subsequent anaesthetics and called "Checking before induction form". RESULTS: During phase I, the detailed and simplified forms of the checklist were only used in 54% and 32% of cases respectively. They were more often completed in scheduled (93%) than in emergency cases (31%). The detailed checklist detected 5/165 potentially severe abnormalities in the breathing system that could be amended before use. After formal discussion with all members of the department, the simplified checklist was abandoned, as it did not detect any significant abnormality and was considered too time-consuming. During the phase II of the study, as the staff checked the anaesthetic machine more often in emergency cases (52%), the overall compliance increased (73%) but remained insufficient. However, no critical incident could be detected during the second evaluation period. DISCUSSION: This study demonstrated the safety benefits associated with the procedure of checking anaesthetic equipment, but also pointed out the difficulty to obtain a full participation of the staff in quality-assurance programmes.
Anesthesiology↗
Nitrogen, carbon and phosphorus mineralization in soils from semi-arid highlands of central Mexico amended with tannery sludge.
Tannery sludge contains valuable nutrients and could be used as a fertilizer to pioneering vegetation in heavily eroded soils of the semi-arid highlands of central Mexico. Soil collected under and outside the canopy of mesquite (Prosopis laeviginata), huizache (Acacia tortuoso) and catclaw (Mimosa biuncifera), and cultivated with maize (Zea mays) and beans (Phaesolus vulgaris) was amended with 1.5 g tannery sludge kg-1 soil or 210 kg dry sludge ha-1 or left unamended. Amended and unamended soils were incubated aerobically for 70 days at 22 +/- 2 degrees C and CO2 production, available P, and inorganic N concentrations were monitored. The CO2 production rate, total C and P, available P, biomass C and P were larger under the canopy of the vegetation than outside of the canopy. The soils were depleted of N as more than 50 mg N kg-1 soil could not be accounted for in the first days of the incubation. Nitrification showed a lag, which lasted 28 days, and concentration of available P remained constant or increased slightly. Application of tannery sludge to soil increased CO2 production with 6.5 mg CO2 kg-1 soil d-1 and inorganic N with 30 mg N kg-1 soil after 70 days, but available P did not increase. Application of tannery sludge increased C and N mineralization and could thus provide valuable nutrients to a pioneer vegetation. Although no inhibitory effects on the biological functioning of the soil were found, further investigation into possible long-term environmental effects are necessary.
Biomass↗
Private health insurance of the Medicare population and the Baucus legislation.
The appropriateness of the benefits associated with the private insurance coverage of the Medicare population has been the subject of considerable concern. Section 507 of the Social Security Amendments of 1980, also known as the Baucus legislation, reflects public concerns about the level of benefits in relation to premiums, duplicative coverage, the complexity and difficulty of insurance terminology, and marketing abuses. Data from the National Medical Care Expenditure Survey can provide useful baseline data on the distribution of Baucus-like plans. In 1977, private insurance held by the Medicare population was more likely to cover inpatient than outpatient services and to emphasize "first dollar" benefits for long-term care. Multivariate analyses show that the distribution of Baucus-like insurance policies is highly associated with health status, source of insurance, region, and place of residence. The importance of state regulations, suggested in other research, may account for these patterns.
Aged↗
Substrate specificity and colorimetric assay for recombinant TrzN derived from Arthrobacter aurescens TC1.
The TrzN protein, which is involved in s-triazine herbicide catabolism by Arthrobacter aurescens TC1, was cloned and expressed in Escherichia coli as a His-tagged protein. The recombinant protein was purified via nickel column chromatography. The purified TrzN protein was tested with 31 s-triazine and pyrimidine ring compounds; 22 of the tested compounds were substrates. TrzN showed high activity with sulfur-substituted s-triazines and the highest activity with ametryn sulfoxide. Hydrolysis of ametryn sulfoxide by TrzN, both in vitro and in vivo, yielded a product(s) that reacted with 7-chloro-4-nitrobenz-2-oxa-1,3-diazole (NBD-Cl) to generate a diagnostic blue product. Atrazine chlorohydrolase, AtzA, did not hydrolyze ametryn sulfoxide, and no color was formed by amending those enzyme incubations with NBD-Cl. TrzN and AtzA could also be distinguished by reaction with ametryn. TrzN, but not AtzA, hydrolyzed ametryn to methylmercaptan. Methylmercaptan reacted with NBD-Cl to produce a diagnostic yellow product having an absorption maximum at 420 nm. The yellow color with ametryn was shown to selectively demonstrate the presence of TrzN, but not AtzA or other enzymes, in whole microbial cells. The present study was the first to purify an active TrzN protein in recombinant form and develop a colorimetric test for determining TrzN activity, and it significantly extends the known substrate range for TrzN.
Amino Acid Sequence↗
Bioremediation of residual fertilizer nitrate: I. Laboratory demonstration of an on-farm in situ pollution control system.
This exploratory laboratory study was undertaken to develop and test an in situ bioremediation system intended to point the way toward a possible field application. The proposed method uses a water table management (WTM) system to deliver nutrients or other amendments to subsoil microorganisms for biostimulation and subsequent biodegradation of pollutants in the saturated and unsaturated zones of the soil. The study was carried out on packed soil columns and bioremediation of residual fertilizer nitrate was attempted. Different levels of organic carbon supplement (glucose C) were introduced into these columns via subirrigation in order to supplement the readily available organic carbon levels in the soil. The study was carried out in two experimental setups. The first setup investigated (i) the effect of addition of a high (970 mg L(-1)) and a low (120 mg L(-1)) glucose C level and (ii) the efficacy of using the subirrigation system as a method for nutrient delivery in bioremediation of leached nitrate. This setup was monitored with time, depth, and with reference to the nitrate residue in the soil solution. Leached nitrate was denitrified to less than 10 mg L(-1) nitrate N at both glucose levels. The second setup investigated the effect of a range of low levels of glucose C on nitrate decontamination, soil pH, and total microbial count in order to find out an optimal glucose C level that reduced the most nitrate and maintained the pH homeostasis of soil.
Agriculture↗
Patterns of psychiatric hospital service use in Finland: a national register study of hospital discharges in the early 1990s.
We were interested in studying the possible concurrent changes in the psychiatric inpatient population during a rapid phase of deinstitutionalisation, and severe economic recession with a record level unemployment rate, and after the amendment of the mental health legislation. Although there were 4540 fewer beds in the psychiatric hospitals in 1993 compared to 1990, the rate of patient admissions remained the same. There was a significant increase in readmissions (P < 0.001) to the psychiatric hospitals, and particularly in multiple (three or more) readmissions among new inpatients (P < 0.001). The prevalence of inpatients with major depression increased by 0.2/1000 in the whole cohort and by 0.12/1000 among first-timers from 1990 to 1993 (P < 0.001). In addition, the rate of involuntary admissions decreased significantly (P < 0.001).
Adolescent↗
Pramlintide: (AC 137, AC 0137, Symlin, Tripro-Amylin).
Adis CommentsPramlintide [AC 0137, AC 137, tripro-amylin, Symlin] is a synthetic human amylin analogue with proline substitutions at positions 25, 28 and 29, which limits the self-aggregation seen with native amylin. Pramlintide improves glycaemic control, and appears to reduce postprandial blood glucose peaks and flatten the glucose peaks and troughs observed in diabetic patients. The reduction of hypoglycaemia would be an immediate advantage, and the reduction of hyperglycaemia could potentially prevent diabetic complications. Development - US: Amylin has submitted an NDA in the US for pramlintide acetate (Symlin trade mark ) as an adjunctive therapy for the treatment of type 1 and type 2 diabetes mellitus. However, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee at their meeting on 26 July 2001, voted not to recommend approval of pramlintide for type 1 and type 2 diabetes. Although eight out of nine Committee members were convinced of the potential of pramlintide therapy, the Committee expressed concerns regarding safety issues and requested additional data addressing these concerns. Finally, on 12 October 2001, Amylin received an 'approvable letter' for Symlin- for the treatment of diabetes. In April 2002, Amylin commenced a trial in 250 patients with type 1 diabetes to evaluate the safety issues regarding cases of severe hypoglycaemia with pramlintide in combination with insulin reported in this group of patients. The trial will investigate dose titration in the initial first month of the treatment period combined with insulin adjustment for the optimisation of glucose control. Patients are then treated for 6 months at a steady-state dose of pramlintide or placebo, accompanied by the additional insulin adjustments. Amylin has completed patient enrolment in September 2002. Final approval is subject to satisfactory results from this safety and dose titration study and the four small pharmacology studies already completed or underway. Amylin plans to file an amendment to the pramlintide's NDA in the Q1 of 2003. Development - non-USA: A wholly owned subsidiary of Amylin Pharmaceuticals, Amylin Europe, filed a regulatory submission with the European Agency for Evaluation of Medicinal Products (EMEA) and Switzerland for pramlintide for the treatment of both type 1 and type 2 diabetes under the centralised procedure. Amylin completed pivotal phase III clinical trials with pramlintide acetate (Symlin trade mark ) for the treatment of type 1 and type 2 diabetes mellitus in North America and Europe. However, in October 2002, Amylin announced that following consultation with the Committee for Proprietary Medicinal Products (CPMP) of the EMEA, it has found that additional information is necessary to proceed with review of the MAA for pramlintide for diabetes. Since, the centralised procedure does not allow the adding of new information to the application that is already under review, Amylin has decided to withdraw the MAA for pramlintide. The company will continue discussions with the EMEA to clarify the information required for a resubmission of the application. The submission for pramlintide in Switzerland is currently under review. In a separate phase II programme, Amylin is investigating the use of pramlintide in type 2 diabetes mellitus patients who are not achieving satisfactory results with oral hypoglycaemic agents but who have not progressed to using insulin. Collaborations: Pramlintide was under joint development with Amylin Pharmaceuticals and Johnson and Johnson, as an injectable partner hormone for insulin for the treatment of both type 1 and type 2 diabetes mellitus. The terms of the agreement between Amylin and Johnson and Johnson were that Amylin had primary responsibility for development and regulatory submissions, while Johnson and Johnson had primary responsibility for marketing; development costs and eventual profits were to be shared equally. Later, Johnson and Johnson decided to terminate the collaboration to commercialise pramlintide. An earlier development collaboration betweion between Amylin and Glaxo Wellcome was also discontinued. However, Amylin is in new ongoing discussions with collaborative partners for pramlintide in Europe and Japan. Amylin has signed an agreement with CP Pharmaceuticals in the UK to manufacture pramlintide.
Amyloid↗
Evaluation of an information booklet for patients considering participation in phase I clinical trials in cancer.
Phase I trials in cancer patients, although essential, are a difficult field of clinical research. A particularly challenging area for all members of the clinical research team is that concerned with information-giving and informed consent leading to patient participation in the trial. An information booklet for patients was written in an attempt to address some of those issues, with the overall aim of improving the informed consent process and influencing patient decision-making. Questions covered in the booklet include: What is a phase I trial? Who can take part? Are there any side-effects or risks involved? What if I say no? The booklet was given to patients prior to consent. On the first day of receiving treatment they were given a questionnaire to evaluate the usefulness and acceptability of the booklet. The results showed the booklet to be generally well accepted by patients and the majority of them perceived the content and volume of information to be appropriate. The booklet did support patient decision-making and the evaluation showed that the optimal time for patients to receive it was prior to the signing of a consent form. Minor amendments have been made to the booklet, which is now given routinely to all patients at the cancer centre who are considering participation in a phase I trial, and is a valuable addition to the informed consent process.
Clinical Trials, Phase I as Topic↗
Pilot randomized study of early tacrolimus withdrawal from a regimen with sirolimus plus tacrolimus in kidney transplantation.
We performed a randomized trial to compare two regimens of low-risk kidney allograft recipients in the first year after transplantation. Both regimens initially included sirolimus, tacrolimus and steroids; one with long-term maintenance with these drugs vs. tacrolimus withdrawal. Group I: sirolimus levels of 4-8 ng/mL, plus tacrolimus 8-12 ng/mL for 3 months, and 5-10 ng/mL after month 3. Group II: sirolimus concentration of 8-16 ng/mL, plus tacrolimus 3-8 ng/mL with tacrolimus elimination from month 3 onwards. Owing to difficulties in achieving target levels, the protocol was amended to increase the doses. Eighty-seven patients were recruited. In the intention-to-treat analysis, glomerular filtration rate (GFR) at 12 months, adjusted to zero for graft loss, was similar in both groups (58.8 and 59.9 mL/min). Analysis of patients remaining on protocol showed that GFR was higher in group II only in the patients postamendment (58.4 and 72.9 mL/min, p = 0.03). Rates of biopsy-confirmed rejection (BCAR) were 9.3% and 22.7% in groups I and II, respectively (p = NS). After amendment, BCAR rates were 10.3% and 11.1% (p = NS). Diastolic blood pressure was significantly lower in patients who eliminated tacrolimus (80.4 vs. 75.6 mmHg) (p = 0.03). Combining sirolimus and tacrolimus with adequate loading doses was associated with a low incidence of BCAR, and allowed tacrolimus elimination in a high proportion of patients, which may be followed by amelioration in renal function and blood pressure.
Adult↗
Biodegradation of [(sup14)C]Benzo[a]pyrene Added in Crude Oil to Uncontaminated Soil.
To investigate the possible cometabolic biodegradation of benzo[a]pyrene (BaP), crude oil spiked with [7-(sup14)C]BaP and unlabeled BaP was added to soil with no known pollution history, to give 34 g of oil and 67 mg of BaP/kg of dry soil. The oil-soil mixture was amended with mineral nutrients and incubated in an airtight container with continuous forced aeration. Total CO(inf2) and (sup14)CO(inf2) in the off-gas were trapped and quantified. Soil samples were Soxhlet extracted with dichloromethane at seven time points during the 150-day incubation period, and the extracted soil was subjected to further fractionation in order to recover reversibly and irreversibly bound radiocarbon. Radiocarbon recovery was 100% (plusmn) 3% for each time point. During the first 50 days of incubation, no (sup14)CO(inf2) was evolved, but over the next 100 days, 50% of the BaP radiocarbon was evolved as (sup14)CO(inf2). At 150 days, only 5% of the intact BaP and 23% of the crude oil remained. Of the remaining radiolabel, 20% was found in solvent-extractable metabolites and 25% was incorporated into soil organic matter. Only 1/10 of this could be solubilized by chemical hydrolysis. An abiotic control experiment exhibited binding of only 2% of the BaP, indicating the microbial nature of the BaP transformations. We report that in soil containing suitable cosubstrates, BaP can be completely degraded.
Journal Article↗
To what extent can the law control human cloning?
This paper explores the legal ramifications of human reproductive cloning in response to 'Dolly'--the first animal cloned from an adult cell. No attempt is made to address the complex moral and ethical dilemmas that will inevitably be consequential on future successes in human reproductive cloning. Some of the potential benefits of cloning are briefly summarized but discussion is focused primarily on the current state of the law in the UK and some other European jurisdictions. Attempts to legislate on human cloning in the US, the emerging role of the EU and amendments to the European Convention on Human Rights are outlined. The potential problems likely to be encountered in the enforcement of any global treaties or international regulations are highlighted. It is argued that attempting to control human cloning by imposing legal prohibition is futile and a pragmatic solution to this impending problem is required forthwith.
Adult↗