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PubMed2002

Euthanasia and physician-assisted suicide in Scandinavia--with a conceptual suggestion regarding international research in relation to the phenomena.

This article analyses and compares recent research on Scandinavian physicians' attitudes towards, as well as their practice of, euthanasia and physician-assisted suicide. The studies discussed are quite dissimilar in their design, resulting in considerable difficulties as far as comparability is concerned. Such difficulties are common in these fields of research. As an intended contribution to the amendment of future research, we suggest what we take to be detailed and precise definitions of the terms euthanasia and physician-assisted suicide for use internationally. Our definitions, or interpretations, basically draw on the Dutch experience and understanding of these terms. The Dutch approach implies that acts of abstention from life-prolonging treatment, i.e., withholding and withdrawing treatment, and pain and symptom treatment that theoretically could shorten life (including terminal sedation) are to be considered 'normal medical practice'. Furthermore, death is seen as having natural causes in all of these acts. That, however, is not the case with euthanasia and physician-assisted suicide. When a physician performs either of these acts, he or she is required to state 'unnatural death' in the patient's death certificate. Our conceptual suggestions do not address the ethical status of the various medical decisions that are made with regard to the death of patients; our aim is conceptual clarity only. As far as euthanasia and physician-assisted suicide in Scandinavia is concerned, even though comparisons prove difficult, we do think some observations may be made: physicians from Norway, Denmark and Sweden display differences in both attitude and practice concerning these phenomena. Norwegian physicians are most restrictive with regard to attitude. Danish and Swedish physicians display a more liberal attitude, the latter being the most liberal. These findings did not fit the physicians' practice. Danish physicians have performed euthanasia and physician-assisted suicide more often than Norwegian physicians. Swedish physicians, even though they are the most liberal when it comes to attitude, appear never to have performed euthanasia and very seldom physician-assisted suicide.

Attitude of Health Personnel↗

PubMed1988

Frisby v. Schultz, 27 June 1988.

The plaintiffs, anti-abortion protesters, challenged a Brookfield Wisconsin ordinance making it "unlawful for any person to engage in picketing before or about the residence or dwelling of any individual" and declaring that the primary purpose of the ban is to "protec[t] and preserv[e] the home" through assurance "that members of the community enjoy in their homes . . . a feeling of well-being, tranquillity, and privacy." They claimed that the ordinance violated their First Amendment rights of free speech. The Court reversed lower court rulings finding the ordinance unconstitutional. It held that the ban on picketing did not ban all picketing in residential areas, but, rather, only "focused picketing" taking place solely in front of a specific residence, and that the ordinance left ample means of alternative channels of communication. It concluded that the ordinance served a significant government interest of protecting residential privacy and that there was no constitutional right to force speech into the home of an unwilling listener. In 1988, US courts reached the following decisions with respect to the activities of anti-abortion protesters: 1) action charging anti-abortionists with conspiracy under federal laws is allowed (Portland Feminist Women's Health Center vs. Advocates for Life, US District Court, D. Oregon, 28 June 1988 [712 F.Supp. 165]); 2) action charging anti-abortionists with conspiracy under federal laws not allowed, but action charging anti-abortionists with violation of racketeering laws allowed (Feminist Women's Health Center vs. Roberts, US District Court, W.D. Washington, 11 March 1988 [1988 US Dist. Lexis 16325]); 3) action charging anti-abortionists with violation of racketeering laws allowed (Northeast Women's Center, Inc. vs. McMonagle, US District Court, E.D. Pennsylvania, 31 March 1988 [689 F.Supp. 465]); and 4) action charging anti-abortionists with conspiracy under federal laws and with violation of racketeering laws is allowed (Roe vs. Operation Rescue, US District Court for the Eastern District of Pennsylvania, 19 December 1988 [1988 US District Lexis 14484]).

Abortion, Induced↗

PubMedDate not supplied

The Medicaid cutoff and abortion services for the poor.

Since 1977, the Hyde Amendment's restrictions on federal funding of abortions have prevented poor women from obtaining abortions through the federal Medicaid program. This article describes research undertaken to determine the impact of these restrictions on low-income women. Patients who had Medicaid-funded abortions at a clinic in St. Louis, Missouri, in 1977 (when Medicaid funding of abortions was available) were compared with Medicaid-eligible patients who had abortions at the same clinic in 1982 (when public funding of abortions was allowed only if the woman's life would be endangered by continuation of the pregnancy). Their experiences were also compared with those of higher income women attending the same clinic in both years. Finally, some of the 1982 patients were interviewed in 1983 to determine how they went about raising the money that they needed to pay for their abortions. In 1977, Medicaid-eligible patients experienced no delay in obtaining abortions compared with other women, even when demographic differences are considered. However, in 1982, they were significantly delayed; on average, the Medicaid-eligible women who were delayed had abortions 2-3 weeks later than the others. Fifty percent of patients eligible for Medicaid in 1982 had abortions at 10 weeks of gestation or later, compared with 37 percent in 1977. Medicaid-eligible women who were interviewed in depth had abortions about a week later than the other women. Increased delays occurred both between their first suspicion of pregnancy and their pregnancy test and between their decision to have an abortion and the procedure.(ABSTRACT TRUNCATED AT 250 WORDS)

Abortion, Induced↗

PubMed2006

The role of disease burden measures in future estimates of endemic waterborne disease.

The 1996 Safe Drinking Water Act amendments require the US Environmental Protection Agency and the Centers for Disease Control and Prevention to develop a national estimate of the occurrence of waterborne infectious disease that is attributable to public drinking water systems in the United States. Much of the information for developing the national estimate will be derived from epidemiologic data, and the primary outcome of this effort will be an estimate of the number of cases of gastrointestinal illness. While quantifying the number of these cases provides some measure of waterborne disease impact, the usefulness of this measure may be limited because the full spectrum of societal impact also involves consideration of the additional effects of these diseases such as hospitalization costs and lost productivity. If decision-makers wish to compare the impact of waterborne infectious diseases to the impact of some other public health concern (e.g. to aid in resource allocation decisions), then a comparison of case numbers may prove inadequate. Case numbers alone do not provide sufficient information about the severity of different illnesses. Society may value the avoidance of a few cases of severely debilitating illness more than it values the avoidance of many cases of mild illness. In order to compare disparate public health concerns, "burden of disease" measures that incorporate indicators of disease severity, costs, or societal values may prove essential for some types of decisions. We describe epidemiologic measures of severity, quality adjusted life years (QALYs), disability adjusted life years (DALYs), willingness-to-pay, and cost-of-illness methods commonly used for burden of disease estimates, and discuss how some of these summary measures of burden might be used for waterborne disease estimates.

Chronic Disease↗

PubMed2005

Phase I and pharmacokinetic study of DE-310 in patients with advanced solid tumors.

PURPOSE: To assess the maximum-tolerated dose, toxicity, and pharmacokinetics of DE-310, a macromolecular prodrug of the topoisomerase I inhibitor exatecan (DX-8951f). in patients with advanced solid tumors. EXPERIMENTAL DESIGN: Patients received DE-310 as a 3-hour infusion once every 2 weeks (dose, 1.0-2.0 mg/m(2)) or once every 6 weeks (dose, 6.0-9.0 mg/m(2)). Because pharmacokinetics revealed a drug terminal half-life exceeding the 2 weeks administration interval, the protocol was amended to a 6-week interval between administrations also based on available information from a parallel trial using an every 4 weeks schedule. Conjugated DX-8951 (the carrier-linked molecule), and the metabolites DX-8951 and glycyl-DX-8951 were assayed in various matrices up to 35 days post first and second dose. RESULTS: Twenty-seven patients were enrolled into the study and received a total of 86 administrations. Neutropenia and grade 3 thrombocytopenia, and grade 3 hepatotoxicity with veno-occlusive disease, were dose-limiting toxicities. Other hematologic and nonhematologic toxicities were mild to moderate and reversible. The apparent half-life of conjugated DX-8951, glycyl-DX-8951, and DX-8951 was 13 days. The area under the curve ratio for conjugated DX-8951 to DX-8951 was 600. No drug concentration was detectable in erythrocytes, skin, and saliva, although low levels of glycyl-DX-8951 and DX-8951 were detectable in tumor biopsies. One patient with metastatic adenocarcinoma of unknown primary achieved a histologically proven complete remission. One confirmed partial remission was observed in a patient with metastatic pancreatic cancer and disease stabilization was noted in 14 additional patients. CONCLUSIONS: The recommended phase II dose of DE-310 is 7.5 mg/m(2) given once every 6 weeks. The active moiety DX-8951 is released slowly from DE-310 and over an extended period, achieving the desired prolonged exposure to this topoisomerase I inhibitor.

Adult↗

PubMed2006

Florida's weakened motorcycle helmet law: effects on death rates in motorcycle crashes.

OBJECTIVES: Effective July 1, 2000, Florida's universal helmet law was amended to exclude riders ages 21 and older with insurance coverage providing at least 10,000 US dollars in medical benefits for injuries sustained in a motorcycle crash. Observed helmet use in Florida was reported to have declined from nearly 100% in 1998, before the law change, to 53% after. This study examined the effects of the law change on the likelihood of death, given involvement in a motorcycle crash. METHODS: Rates of motorcyclist deaths per crash involvement in Florida for 2001-2002 (after the law change) were compared with those for 1998-1999 (before the law change). Before/after death rate ratios (95% CIs) were examined, and logistic regression models estimated the effect of the helmet law change on the odds of death in a crash, while controlling for rider gender, age, and seating position, and number of vehicles. RESULTS: The motorcyclist death rate increased significantly after the law change, from 30.8 to 38.8 deaths per 1,000 crash involvements. Motorcyclist death rates increased for single- and multiple-vehicle crashes, for male and female operators, and for riders of all ages including those younger than 21. After controlling for gender and age, the likelihood of death given involvement in a motorcycle crash was 25% higher than expected after the law change. It is estimated that 117 motorcyclist deaths could have been avoided during 2001-2002 if Florida's universal helmet law had remained in place. CONCLUSIONS: This study provides evidence of the life-saving benefits of universal helmet laws. The results also suggest that age-specific helmet laws are not effective in protecting the youngest drivers. This is not surprising, as these laws are largely unenforceable.

Accidents, Traffic↗

PubMed2004

A phase I trial of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone in combination with gemcitabine for patients with advanced cancer.

PURPOSE: 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP), a new and potent inhibitor of ribonucleotide reductase (RR), increases the cellular uptake, DNA incorporation, and cytotoxicity of gemcitabine in tumor cell lines. A phase I trial was initiated to determine the safety profile and maximum tolerated doses of 3-AP and gemcitabine when used in combination in patients with advanced cancer. STUDY DESIGN: 3-AP and gemcitabine were administered on days 1, 8, and 15 of each 28-day cycle. Initially, 3-AP was infused over 2 h at a fixed dose of 105 mg/m(2). Gemcitabine was given over 30 min beginning no less than 1 and no more than 4 h after 3-AP. The first cohort received 3-AP alone in the first cycle. Subsequently, the gemcitabine dose was escalated beginning at 600 mg/m(2) in cohorts of three to six patients. Following the gemcitabine 1000 mg/m(2) dose level, the study was amended to determine if the 3-AP dose could be escalated above 105 mg/m(2). RESULTS: 3-AP at 105 mg/m(2) administered over 2 h followed in 1-4 h by gemcitabine at 1000 mg/m(2) produced a toxicity profile similar to that expected for gemcitabine alone at the same dose. When the dose of 3-AP was escalated to 140 and 185 mg/m(2) administered over 2 h and subsequently over 4 h, acute hypotension, hypoxia, and EKG changes including non-specific ST-T wave changes and mild QT prolongation were observed, and one patient with underlying diffuse coronary artery disease had an asymptomatic myocardial infarction. 3-AP was shown to cause mild, reversible methemoglobinemia. Average end-of infusion serum concentrations for 3-AP at all doses were within the range capable of enhancing gemcitabine cytotoxicity in vitro. Gemcitabine plasma concentrations at end-of-infusion and elimination half-life were consistent with values reported in the literature. Among 22 evaluable patients, one complete response and two partial responses were observed, and an additional patient had prolonged stabilization of a large liver metastasis. CONCLUSIONS: 3-AP at 105 mg/m(2) infused over 2-4 h followed by gemcitabine at 1000 mg/m(2) on a days 1, 8, and 15 schedule every 28 days was generally well-tolerated and had a toxicity profile similar to that of gemcitabine alone. 3-AP produced mild to modest methemoglobinemia, which could cause acute symptoms in patients with limited pulmonary or cardiovascular reserve. The combination demonstrated antitumor activity and merits further exploration in phase II trials.

Adult↗

PubMed2006

A phase I study of a new nucleoside analogue, OSI-7836, using two administration schedules in patients with advanced solid malignancies.

PURPOSE: To investigate the safety, tolerability, and pharmacokinetic profile of the novel nucleoside analogue OSI-7836 in patients with advanced solid malignancies. EXPERIMENTAL DESIGN: OSI-7836 was initially given as a 60-minute i.v. infusion on day 1 every 21 days. In view of its dose-limiting toxicities, the administration time was amended to a 5-minute bolus, and subsequently, the schedule was amended to weekly for 4 weeks followed by a 2-week rest. Blood and urine samples were collected for pharmacokinetic studies. Analyses of cytokines and lymphocyte subsets were added later in the study to elucidate a mechanism for the severe fatigue and lymphocyte depletion observed in earlier patients. RESULTS: Thirty patients received a total of 61 treatment cycles. Fatigue was the main dose-limiting toxicity. Maximum-tolerated dose was defined as 300 mg/m2 in the 60-minute infusion, (three times per week) schedule; 400 mg/m2 in the 5-minute bolus infusion, (three times per week) schedule; and 100 mg/m2 in the weekly schedule. Other common toxicities were nausea, vomiting, rash, fever, and a flu-like syndrome. There were no clinically significant hematologic toxicities. Following the initial dose, OSI-7836 was eliminated from plasma with a median (range) elimination half-life of 48.3 minutes (22.6-64.8 minutes). Lymphocyte subset analysis showed a significant drop in B cell counts, which persisted to day 14 and beyond. Cytokine analysis showed significant elevations of interleukin-6 and interleukin-10 in all patients who received > or = 200 mg/m2 OSI-7836. Best response was disease stabilization in seven patients. CONCLUSION: OSI-7836 was associated with excessive fatigue, and despite changes in its schedule and duration of administration, we did not observe an improvement in its tolerability. Its potentially selective effect on B lymphocytes could be exploited in further studies in specific hematologic malignancies.

Adult↗

PubMedDate not supplied

[Epidemiological study of Chlamydia trachomatis infection in a sample of women requesting voluntary termination of pregnancy, treated with rokitamycin].

BACKGROUND: Infection with Chlamydia trachomatis usually involves the cervix uteri, causing no symptoms, and may easily be unrecognised and untreated until troublesome symptoms arise, such as pelvic inflammatory disease, which can affect fertility and reproductive life. Therapies include the macrolide antibiotics, and in this class rokitamycin offers marked lipophilia, excellent intracellular penetration, and bactericidal activity at concentrations close to the MIC. The present study was therefore designed to establish the frequency of intracervical infection with Chlamydia trachomatis in women applying for termination of pregnancy, and to assess the efficacy and safety of this drug in this indication. METHODS: Women aged 18-40 years were admitted for termination of pregnancy, with a positive cervical swab for Chlamydia trachomatis. The study was conducted in accordance with the Declaration of Helsinki and amendments. Patients were given one oral tablet of 400 mg rokitamycin in the morning, and one in the evening, for two weeks. Treatment started ten days before the termination, within 48 h of taking the swab. Partners were to receive the same treatment. RESULTS: 292 women requiring termination of pregnancy, on average at the 9th week of pregnancy, were assessed. Of these, 24 (8.2%), mean (+/- SD) age 27.1 +/- 6.1 years, range 18-39, with a positive cervical swab for Chlamydia trachomatis, were treated with rokitamycin; 22 of their partners were treated too. Forty days after the start of treatment 22 patients (92%) gave negative results; these were all the cases whose partners had received treatment. No adverse events were reported and the acceptability of the treatment was considered good or excellent in 91% and fair in 9% of the cases. CONCLUSIONS: The findings confirm that rokitamycin is one of the most useful and effective macrolides for the treatment of infections caused by intracellular microorganisms; it is extremely well tolerated and has marked microbiological efficacy.

Abortion, Therapeutic↗

PubMed2002

Regulatory aspects of noninvasive glucose measurements.

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the Act) established three regulatory classes for medical devices. Section 513 of the Act specifies three classes based upon the degree of control and Food and Drug Administration (FDA) oversight that is necessary to assure that the various types of devices are safe and effective. High-risk devices are placed into the most regulated device class, Class III. Under Section 515 of the Act, all devices placed in Class III are subject to premarket approval (PMA) requirements. PMA by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Advisory panel review is required of virtually all original submissions. Manufacturing facilities of devices requiring PMA approval are also subject to preapproval inspection to assure data integrity and compliance with good manufacturing practices. An approved PMA is granted for marketing a particular medical device for a particular intended use. FDA considers noninvasive and minimally invasive glucose devices that are intended to measure, monitor, or predict blood glucose levels in diabetics to be high-risk medical devices. These devices will have a significant potential impact on the medical care of people with diabetes. The technology offers potential improvements in the quality of life, enhanced blood glucose control through increased frequency of testing, or access to testing, in a broader range of patients. However, the technology is not yet well understood, and the information obtained from these devices is often different from the information that has been the traditional base for the management of diabetes. As a result, FDA requires both analytical and clinical studies to support the intended claims for these new devices.

Blood Glucose↗

PubMed2001

[Long-term oxygen therapy (LTOT) in chronic obstructive lung disease (COL)].

UNLABELLED: A substantive amendment to this systematic review was last made on 12 April 1999. Cochrane reviews are regularly checked and updated if necessary. BACKGROUND AND OBJECTIVES: To determine the effect of domiciliary oxygen therapy on survival and quality of life in patients with chronic obstructive pulmonary disease. SEARCH STRATEGY: Randomised controlled trials (RTCs) were identified using the Cochrane Airways Group Chronic Obstructive Pulmonary Disease (COPD) register using the search terms: home or domiciliary and oxygen. SELECTION CRITERIA: Any randomised controlled trial in patients with hypoxia and chronic obstructive pulmonary disease that compared long term domiciliary or home oxygen therapy with a control treatment. DATA COLLECTION AND ANALYSIS: Data extraction was performed independently by two reviewers. MAIN RESULTS: Four randomised controlled trials were identified. Data from none of these trials could be aggrigated because of differences in trial design and patient selection. Trial 1, continuous oxygen therapy versus nocturnal oxygen therapy: there was a significant improvement in mortality after 24 months (Peto odds ratio 0.45, 95% confidence interval 0.25 to 0.81). Trial 2, oxygen versus no oxygen: there was a significant improvement over five years in mortality in the group receiving oxygen (Peto odds ratio 0.42, 95% confidence interval 0.18 to 0.98). Trial 3, nocturnal oxygen versus no oxygen in patients with arterial desaturation at night: there was no difference in mortality at 36 months. Trial 4, long term oxygen versus no oxygen in moderate hypoxaemia: there was no effect on survival for up to three years of follow up. REVIEWERS' CONCLUSION: Long term oxygen therapy improves survival in a selected group of COPD patients with severe hypoxaemia (arterial PO2 less than 8.0 kPa). Long term oxygen does not appear to improve survival in patients with moderate hypoxia or those who only have arterial desaturation at night.

Contraindications↗

PubMed2006

Preoperative chemotherapy for resectable thoracic esophageal cancer.

BACKGROUND: Surgery has been the treatment of choice for localized esophageal cancer. A number of studies have investigated whether preoperative chemotherapy followed by surgery leads to an improvement in cure rates but the individual reports have been conflicting. An explicit systematic update of the role of preoperative chemotherapy in the treatment of resectable thoracic esophageal cancer is, therefore, warranted. OBJECTIVES: The objective of this review is to determine the role of preoperative chemotherapy on patients with resectable thoracic esophageal carcinomas. SEARCH STRATEGY: Trials were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to 2006), EMBASE (1988 to 2006) and CANCERLIT (1993 to 2002). There were no language restrictions. SELECTION CRITERIA: All trials of patients with potentially resectable carcinomas of the esophagus (of any histologic type) who were randomised to having either chemotherapy or no chemotherapy before surgery. DATA COLLECTION AND ANALYSIS: The primary outcome was survival, which was assessed using hazard ratios. This is an amendment to the original review which used relative risks to assess survival at yearly intervals. Hazard ratios (HR) have now been introduced to summarise the complete survival experience in a single analysis. The risk ratio (relative risk; RR) was used to compare rates of resections, tumour recurrences and treatment morbidity and mortality. MAIN RESULTS: There were eleven randomised trials involving 2019 patients. Eight trials (1729 patients) reported sufficient detail on survival to be included in a meta-analysis for the primary outcome. There was some evidence to suggest that preoperative chemotherapy improves survival, but this was inconclusive (HR 0.88; 95% CI 0.75 to 1.04). There was no evidence to suggest that the overall rate of resections (RR 0.96, 95% CI 0.92 to 1.01) or the rate of complete resections (R0) (RR 1.05; 95% CI 0.97 to 1.15) differ between the preoperative chemotherapy arm and surgery alone. There is no evidence that tumour recurrence (RR 0.81, 95% CI 0.54 to 1.22) or non-fatal complication rates (RR 0.90; 95% CI 0.76 to 1.06) differ for preoperative chemotherapy compared to surgery alone. Trials reported risks of toxicity with chemotherapy that ranged from 11% to 90%. AUTHORS' CONCLUSIONS: In summary, preoperative chemotherapy plus surgery may offer a survival advantage compared to surgery alone for resectable thoracic esophageal cancer, but the evidence is inconclusive. There is some evidence of toxicity and preoperative mortality associated with chemotherapy.

Antineoplastic Agents↗

PubMed2005

[Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)].

With the 12th Law Amending the German Drug Law and the Ordinance on GCP (GCPV), new legal provisions for clinical trials came into force in August 2004. These include specific definitions and differentiated reporting obligations affecting investigators, sponsors, authorities and ethics committees concerning pharmacovigilance in clinical trials. The definitions according to section sign3 (6-8) GCP-V make clear that these provisions focus on those adverse events and adverse drug reactions, which are related to investigational medicinal products. In the GCP-V for the first time legally binding provisions for investigators are laid down defining obligations to report all serious adverse events to the sponsor. The sponsor of clinical trials plays a decisive role concerning the evaluation, documentation and reporting to the competent higher authorities, ethics committees and investigators involved in the clinical trial. In the GCP-V different time limits concerning the reporting for sponsors are laid down. The requirements concerning expedited reporting focus on suspected unexpected serious adverse reactions (SUSARs), i. e. those adverse serious reactions, which are not described in the information on the investigational medicinal product. The time limit for reporting SUSARs leading to death or life-threatening SUSARs is 7 days, while for other SUSARs the time limit is 15 days. Besides the responsibilities on expedited reporting the sponsor has to submit a line listing of all serious adverse reactions which occurred during the clinical trial and a report on the safety of the trial subjects on an annual basis or on request. On the European level the harmonisation concerning the provisions on pharmacovigilance in clinical trials according to the Directive 2001/20/EC and the Eudravigilance database should contribute to reach a faster and more effective exchange of safety information related to clinical trials between the different competent authorities of the EU member states.

Adverse Drug Reaction Reporting Systems↗

PubMed1996

Report 59 of the AMA Board of Trustees (A-96). Physician-assisted suicide. Reference Committee on Amendments to Constitution and Bylaws.

This Board of Trustees report calls for reaffirmation of the position of the American Medical Association (AMA) in opposition to physicians assisting their patients in committing suicide. The AMA maintains that the appropriate step for physicians is not to assist a patient in death but to provide compassion and palliative care. In providing end-of-life care, the option of allowing physicians to intentionally cause the death of patients is a line that should not be crossed. This position is based on the historical role of physicians as advocates for healing. The report discusses AMA activity to design and implement a comprehensive physician education plan on end-of-life care in response to the House of Delegates' action in adopting Board of Trustees Report 48-I-95, "Quality Care at the End of Life." This plan will further the AMA's commitment that patients should receive high quality care during every stage of life, including the end of life. The goal of this educational campaign is to advance the medical culture by making palliative treatment and care directions based on values-based advance care planning the standard of care for meeting the needs of patients at the end of life. The basis for this activity will be the acknowledgment that physicians, while unable to always provide a cure, should always be able to relieve suffering, address the psychological needs of patients at the end of life, add value to remaining life, and help patients die with dignity. The report presents information on state legislative activities and judicial actions relating to physician-assisted suicide. The report also presents a discussion on the ethical under-pinnings against physician participation in patients' suicides. This report recommends that: the AMA reaffirm current policies 140.952 and 140.966 (AMA Policy Compendium), in accordance with Council on Ethical and Judicial Affairs Opinion 2.211 (opposition to physician-assisted suicide); the AMA initiate an educational campaign to make palliative treatment and care directions based on values-based advance care planning the standard of care for meeting the needs of patients at the end of life; the AMA continue to seek out opportunities to present the views of medicine on physician-assisted suicide and improving the quality of care for patients at the end of life; the AMA disseminate this report throughout the Federation with a request that it be distributed to local physicians; and the Board of Trustees present the House of Delegates with an update on these and related activities at the 1996 Interim Meeting and the 1997 Annual Meeting.

American Medical Association↗

PubMed2001

Phase I study of gemcitabine and carboplatin in advanced non-small cell lung carcinoma.

BACKGROUND: This phase I study was designed to determine the maximum tolerated dose of carboplatin with a fixed dose of gemcitabine without growth factor or hematopoietic precursor support. METHODS: Nineteen patients with previously untreated non-small cell lung cancer (NSCLC) were treated at three dose levels. Initially, the gemcitabine dose was 1000 mg/m(2) given on days 1 and 8. Of the first five patients treated with carboplatin AUC 4, three experienced dose limiting toxicity (DLT). The study was, therefore, amended to decrease the dose of gemcitabine to 800 mg/m(2) given on days 1 and 8 in a 21-day cycle. RESULTS: Dose limiting toxicity (neutropenia and thrombocytopenia) were seen at dose level 2A (carboplatin AUC=5). Thus, no further dose escalation was performed. Grade 3 and 4 toxicities were seen as follows: leukopenia in five of 18 (28%); neutropenia, four of 18 (22%); and thrombocytopenia, four of 18 (22%) evaluable patients. Grade 3 or 4 anemia occurred in one of 18 (6%) patients and no neutropenic fever or treatment related mortality was observed. Partial responses were seen in six patients and one patient with evaluable disease had an objective response. The overall response rate was 37% (seven of 19). Six other patients had stable disease. A total of 89 courses were administered with a median of five courses per patient (range: two to six courses). The median time to progression for all patients was 3.7 months. The median overall survival was 7.4 months with four patients still alive (median follow up 13.5 months). The survival at 6 months and 1 year is 64 and 23%, respectively. CONCLUSION: The maximum tolerated dose (MTD) in this group of patients was defined as carboplatin AUC 4 when administered with gemcitabine 800 mg/m(2) on days 1 and 8 of a 21-day schedule.

Adenocarcinoma↗

PubMed2006

Current nutritional treatments of obesity.

Obesity in our country is a growing concern. There are several different options for weight loss; however, individuals must be self-motivated and amendable to change in order to achieve success with their weight loss goals. Several strategies used by professionals in the US today to treat overweight and obesity, include diet therapy, exercise, behavior modification, pharmacotherapy, and surgery. The focus of the American Dietetic Association (ADA) Weight Management Position Statement is no longer just on weight loss but now on weight management. Reaching one's ideal body weight is recommended but not often realistic. Frequently, the goal of treatment shifts to maintenance of ones current weight or attempts at moderate weight loss. Lifestyle modification or behavioral modification interventions rely on analyzing behavior to identify events that are associated with appropriate vs. inappropriate eating, exercise, or thinking habits. Certain primary strategies that have been found to be useful for helping people change their behaviors so that they can lose weight and maintain their weight loss, include self-monitoring, stimulus control, cognitive restructuring, stress management, social support, physical activity, and relapse prevention. Weight loss programs should strive to combine a nutritionally balanced dietary regimen with exercise and lifestyle modifications at the lowest possible cost. There are several different methods used for dietary modifications; low calorie diets, very low calorie diets, fasting, formula diets and meal replacement programs, and popular diets. Bariatric surgery is gaining popularity as it has been an effective way to treat obesity. Following gastric bypass surgery, the patients must be prepared to modify their eating behaviors and dietary selections to assist with weight loss and prevent potential complications. Patients should be educated on the dietary guidelines extensively prior to surgery and again post-operatively.

Bariatric Surgery↗

PubMed2000

Comparison of anticoagulant effects and safety of argatroban and heparin in healthy subjects.

STUDY OBJECTIVE: To evaluate and compare the relationship between dosage and coagulation parameters, as well as safety profiles, of ascending bolus and infusion dosages of argatroban versus heparin in three phase I studies. DESIGN: Two randomized, double-blind studies compared argatroban and heparin, and one open-label, dose-escalation study further evaluated argatroban. SETTING: University teaching hospital clinical research unit. PATIENTS: Healthy men (aged 22-62 yrs). INTERVENTION: In the first study, 36 subjects received an argatroban 30-, 60-, 120-, or 240-microg/kg bolus, or a heparin 30-, 60-, 120-, or 240-U/kg bolus for three subjects, then amended to 15, 30, 60, or 120 U/kg. In the second study, 37 subjects received argatroban 1.25, 2.5, 5, or 10 microg/kg/minute with or without a 250-microg/kg bolus, or heparin 0.15, 0.20, 0.25, or 0.30 U/kg/minute with or without a 125-U/kg bolus. In the third study (open-label), nine subjects received an argatroban 250-microg/kg bolus plus an infusion of 15, 20, 30, and 40 microg/kg/minute. MEASUREMENTS AND MAIN RESULTS: When administered as a bolus dose in the first study, argatroban and heparin both produced dose-related increases in activated clotting time (ACT) and activated partial thromboplastin time (aPTT) within 10 minutes of administration. Dissipation of anticoagulant effect was approximately 4-fold faster for argatroban than for heparin. When administered by infusion with or without a bolus in the second study, argatroban, but not heparin, produced predictable dose-related increases in ACT and aPTT that were generally consistent across both effect measures and modes of administration. Effect steady state was attained by five or more subjects per dosing group receiving argatroban (5-9) but typically two or fewer subjects per group receiving heparin (0-7). Furthermore, upon cessation of infusion, anticoagulant effects dissipated faster for argatroban (effect half-life 18-41 min) than for heparin (effect half-life 23-134 min). When argatroban was infused without a bolus, peak and effect steady-state values for ACT and aPTT generally were attained within 1-3 hours. Data from the second and third studies show that for argatroban dosages up to 40 microg/kg/minute, plasma drug concentrations attained at 4 hours of infusion increased linearly with dose, and weight-adjusted plasma clearance was dose independent. In all studies, argatroban and heparin were well tolerated. CONCLUSION: Anticoagulation was more predictable with argatroban than with heparin as measured by ACT and aPTT, with comparable safety profiles.

Adult↗

PubMedDate not supplied

Post legalisation challenge: minimizing complications of abortion.

Abortion has been legalized in Nepal since September 2002 by 11th amendment to the Muluki Ain. The present study was conducted in Paropakar Shree Panch Indra Rajya Laxmi Devi Maternity Hospital to assess the magnitude of induced abortion, its causes and the types of complications, in the post legalization phase. Prospective descriptive analyses of the patients who were admitted with history of induced abortion from 16th Dec 2003 to 13th March 2004 was carried out. A total of 305 cases of abortion complications were admitted during the three-month study period, which is 39.7% of the total gynaecological admissions (768). Of these 31 (10.25%) patients had history of induced abortion. Half of the induced abortion cases (52%) were of age group 21-29 yrs and 42% had three or more children. 39% of the cases had history of induced abortion at more than 12 weeks and almost half of the cases (48%) had history of family planning. The most common reason for seeking abortion was too many children (59%) followed by illegitimate pregnancy (16%). Twenty-one patients gave history of abortion being performed by doctors and the most common method used was D and C (75%). 77% of cases presented as incomplete abortion and one case presented with uterine perforation, bowel injury and peritonitis. Twenty patients had evacuation under sedation while five had manual vacuum aspiration (MVA); one patient required laparatomy. In two third of the patients intravenous fluid and antibiotics were used. Four patients required blood transfusion. Abortion complications constitute almost 40% of the total gynaecological admissions. Ten percent of the abortion cases had history of induced abortion. Medical persons, mainly doctors, performed most of the cases of induced abortion and D and C was the most commonly used method. However the patients had faced various types of complications. Untrained provider, resulting in serious life threatening injuries, performed more than a third of the cases of induced abortion at more than twelve weeks gestation. This points to the need for improved monitoring of the quality of services provided, and adherence to the criteria set by the procedural order.

Abortion, Induced↗