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Ethical problems raised by anti-HIV vaccination.

At present questions are being asked world-wide about the risk of the AIDS epidemic. The discovery of an anti-HIV vaccine has become an urgent priority, but it also raises a number of sensitive questions. Ethical problems in this field are particularly delicate, since the perspectives of individual health and public health do not seem to coincide. Our research team conducted a review of more than 400 articles on the ethical problems raised by AIDS. We concentrated particularly on the ethical and legal issues raised by research on anti-HIV vaccine. These problems fall into three main categories: therapeutic assays, which must be controlled by a strict agreement defined by international norms; manufacture of the future vaccine, raising legal difficulties which must be faced and solved now; distribution of the vaccine to the population, which should be conducted on a general basis, i.e. it should be offered to all individuals and not only to risk groups.

Animal Experimentation↗

Point and counterpoint. Should HECs make de facto binding decisions?

It is evident that HEC decisions are de facto binding. Our challenge is to recognize the implications of these decisions for patient care. As a result of the passage of the Patient Self-Determination Act and the recent JCAHO rules mandating dispute resolving mechanisms for ethical issues, case review by ethics committees will undoubtedly have an even greater influence on patient care. Therefore, health care institutions and their medical staffs must strive to find the best way to use the inherent powers of hospital ethics committees to enhance patient care decisionmaking.

Decision Making, Organizational↗

The pros and cons of immunisation -- Paper two: the importance of immunisation.

Like other medicine, all vaccines have some side effects or complications; in general the incidence and severity of complications is lower than for pharmaceuticals. When considered on a population basis, the incidence of serious complications of vaccination is minute, when compared with the outcome of natural infection. Enlightened governments, which promote immunisation as a means of minimising the impact of infectious diseases in their communities, also accept the responsibility for any adverse events which can be demonstrated to be vaccine related, and provide compensation and care for people who are affected.

Australia↗

Compliance, coercion, and compassion: moral dimensions of the return of tuberculosis.

Since 1986, we have seen a rise in the occurrence of tuberculosis in the United States. Long considered defeated in this country, the disease is returning with distressing vigor. Outbreaks of MDR-TB, tuberculosis resistant to more than one medication, have been reported around the country. This article analyzes the Centers for Disease Control and Prevention's National Action Plan to Combat Multidrug-Resistant Tuberculosis, with particular focus on the moral dimensions of mandatory directly observed treatment (DOT) and involuntary quarantine. It is proposed that a moral response to the control of tuberculosis must be one which is sustainable and which can effectively curtail the spread of the disease at a minimal cost to individual rights.

Altruism↗

Teaching humanistic and psychosocial aspects of care: current practices and attitudes.

OBJECTIVE: To assess current practices and attitudes toward teaching humanistic and psychosocial aspects of care in internal medicine residency programs. DESIGN AND PARTICIPANTS: Survey questionnaires were sent to residency directors at all 434 internal medicine residency programs accredited in 1985-1986. Response rate for two mailings was 71%. MEASUREMENTS AND MAIN RESULTS: 78% OF RESIDENCY DIRECTORS and 70% of department chairpersons had high or moderately high levels of commitment to teaching humanistic/psychosocial aspects of care, but only 44% of responding programs offered mandatory training, and only 18% offered elective training in these areas. Obstacles to expanded teaching of the humanistic/psychosocial aspects rated high or moderately high by residency directors included insufficient curriculum time (51%), lack of trained faculty (44%), and pressures to reduce both training costs (40%) and patient-care costs (37%). CONCLUSIONS: Most of the training that does occur in the humanistic/psychosocial aspects of care probably happens informally via mentoring and role modeling. Appeals to expand teaching in these areas raise questions regarding what to include in medical training and the proper scope of internal medicine. Sustainable change will depend on the politics of resource distribution and the influence of general internal medicine and primary care on traditional training.

Clinical Competence↗

Science and the common good: indefinite, non-reviewable mandatory detention of asylum seekers and the research imperative.

Despite a strong historical record of resettling and providing care for refugee populations, the Australian Federal Government has increasingly implemented harsh and restrictive policies regarding the treatment and management of asylum seekers. Most controversial of these has been the mandatory detention of asylum seekers, a policy applied indiscriminately and without discretion where individual cases have not been subject to judicial review or time constraints. From the outset health professionals have raised concerns about the possible adverse mental health impacts of prolonged detention. In contrast, government representatives have characterized conditions in detention as benign and comfortable, and have consistently contested criticism of detention, often citing a lack of scientific evidence as tacit support for the continuation of the policy. Nevertheless, requests for access to the detention centres to undertake rigorous scientific investigations have gone unheeded. In this context we argue that the Australian Government has failed to uphold its commitment to good governance by allowing transparency, openness and a willingness to have the impact of its policies scrutinized by scientists. The manifest conflict of interest in the government position leads to a breach in the normal social contract between mental health researchers and those responsible for the policy of detention. There is, we argue, a legitimate moral imperative in such situations for clinical researchers to breach the walls of enforced silence and give a voice to those who are afflicted. This imperative, however, must be carefully balanced against the risks that may face detainees agreeing to participate in such research.

Australia↗

Renal transplantation in prune-belly syndrome.

We assess the effect of the prune-belly syndrome (PBS) on renal transplantation outcome. Six renal transplantations were performed in five boys affected by PBS (median age 5.8+/-2.1 years, median weight 13.6+/-2.4kg). Renal graft survival, graft function, lower urinary tract dysfunction, urinary tract infections (UTIs), associated complications and patients' survival after 1 and 5 years of follow-up were analysed. The rate for 1-5-year graft survival was 66.7% (mean serum creatinine 98-103 micromol/l). The surgical treatment of the documented bladder obstruction (two patients) and the severe abdominal wall deficit (one patient) led to a reduction of UTI: the patients maintained their native urinary tract and none received prophylactic antibiotics. The lack of abdominal wall musculature led to severe mechanical complication in one patient, but Monfort's abdominal wall reconstruction was able to restore the graft's function. The outcome of patients with PBS who undergo renal transplantation is good. Before the transplant, an accurate assessment of urinary tract anomalies and deficiency of the abdominal wall musculature is mandatory, to program the appropriate treatment and obtain a good long-term prognosis for the renal graft.

Abdominal Wall↗

Prevalence of osteoporosis and its reproductive risk factors among Jordanian women: a cross-sectional study.

Extensive differences in the osteoporosis epidemiological pattern among geographic and ethnic groups have been reported. The evidence concerning association of multiple pregnancies, lactations, and other menstrual history factors with low bone mineral density (BMD) remains inconclusive. Previous local studies addressing these issues in Jordan are very restricted. We present a cross-sectional study of Jordanian women who visited outpatient clinics between August 2000 and August 2002 at two community hospitals in Amman City. BMD measurement was performed for all subjects, while comprehensive appraisal of clinical issues related to reproductive status and past medical history was carried out using a structured questionnaire administered to 50% of the subjects. We also attempted to examine the current hypothesis of possible influence of hyperlipidemia and thyroid abnormalities on decreased BMD. According to WHO criteria, 119 (29.6%) were identified as having osteoporosis, 176 (43.8%) were osteopenic, and 107 (26.6%) had normal BMD. The multiple-linear regression analyses at different bone sites revealed that age, years of menopause, low-density lipoprotein (LDL), and follicle-stimulating hormone (FSH) have strong independent associations with decreased BMD at all lumbar and femoral neck regions. The negative effect associated with number of children (live births) and frequency of lactations was only evident at femoral neck. Although years of menstruation, age at menopause, days of menstrual cycle, number of pregnancies, and duration of hormone replacement therapy (HRT) were positively correlated with BMD, they had weaker associations than previous variables. Moreover, in the final multivariable logistic regression model, variables which rendered significantly independent risk factors after adjustment for age and BMI were: current smokers of more that 25 cigarettes/day, postmenopausal women irrespective of HRT use, menopausal years of > or =5 year intervals, natural early menopause, gastrointestinal disease, rheumatoid arthritis, osteoarthritis, hypertension, and thyroid replacement therapy. Ever-lactation, frequent lactation of 4 or more times, duration of lactation interval of 1-6 months and clinical hyperthyroidism were significant protective factors. Hysterectomy with or without oophorectomy, premature ovarian failure, gravidity, menstrual flow pattern, family history of osteoporosis, clinical hypothyroidism, hyperlipidemia, HRT, and corticosteroids therapy were not independent predictors of osteoporosis among our population. It was concluded that the prevalence of this worldwide public health problem among the Jordanian female population is extremely high, and is even found in younger age categories compared to previous international surveys. Though, the number of pregnancies in our multiparous female population showed a negative impact on femoral neck BMD, no evidence of increased risk of osteoporosis among ever-pregnant women was noted. Conversely, the current data analysis highlight many potential risk factors including associated medical illnesses, and other hormonal alterations experienced during menopausal period. Therefore, increased health awareness and intensive screening programs are mandatory for early detection of low bone mass.

Adult↗

Transjugular intrahepatic portosystemic shunt (TIPS): current status and future possibilities.

Since the insertion of the first TIPS in 1989 much has been learned about this therapeutic procedure. It has an established role for the treatment of some complications of portal hypertension: prevention of recurrent variceal bleeding and rescue of patients with acute uncontrollable variceal bleeding. In addition TIPS is useful for Budd-Chiari syndrome, refractory ascites and hepatorenal syndrome, although its specific role in these indications remains to be definitively established. However, the decrease in sinusoidal blood flow induced by TIPS can lead to the patient developing hepatic encephalopathy and liver failure in some cases. Therefore, TIPS should be used with caution in patients with very poor liver function. From a technical point of view, successful placement of TIPS is achieved in more than 98% of cases by experienced groups. At present, evaluation of TIPS dysfunction based on morphology probably leads to an overdiagnosis of this complication since most of these cases are not associated with clinical manifestations (recurrent bleeding or refractory ascites). The major disadvantage of TIPS remains its poor long-term patency requiring a mandatory surveillance program. The indicator for shunt function/malfunction should be the portosystemic pressure gradient, which is best assessed by intravascular measurements. Shunt obstructions may be prevented or reduced by the use of stent-grafts in the future.

Humans↗

Pouch reconstruction in the pelvis.

ILEAL POUCH RECONSTRUCTION: Proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the procedure of choice in mucosal ulcerative colitis (MUC) and familial adenomatous polyposis (FAP). Because the disease is cured by surgical resection, functional results, pouch survival prognosis, and disease or dysplasia control are the major determinants of success. There is controversy as to whether the IPAA should be handsewn with mucosectomy or stapled, preserving the mucosa of the anal transitional zone. Crohn's disease is a contraindication for IPAA, but long-term outcome after IPAA is similar to that for MUC in patients with indeterminate colitis who do not develop Crohn's disease. As development of dysplasia and cancer in the ileal pouch have been reported, a standardized surveillance program is mandatory in cases of MUC, FAP, and chronic pouchitis. COLONIC POUCH RECONSTRUCTION: Construction of a colonic pouch is a widely accepted technique to improve functional outcome after low or intersphincteric resection for rectal cancer. Several randomized studies comparing colo-pouch-anal anastomosis (CPA) with straight coloanal anastomosis (CAA) have found the pouch functionally superior. Most controlled studies cover only 1-year follow-up, but randomized studies with 2-year follow-up show similar functional results of CPA and CAA. Evacuation difficulty as initially observed was related to pouch size, and the results with smaller pouches (5-6 cm) are more favorable, showing adequate reservoir function without compromising neorectal evacuation. The transverse coloplasty pouch may offer several advantages to J-pouch reconstruction. Current series question whether the neorectal reservoir is the physiological key of the pouch, but rather the decreased motility. The major advantage reported with colonic pouch reconstruction is the lower incidence of anastomotic complications.

Adenomatous Polyposis Coli↗

Pricing and reimbursement of pharmaceuticals in Norway.

Although not a member of the EU, Norway participates in the European-wide regulatory framework for granting marketing authorization to pharmaceutical products. Maximum prices for prescription medicines are determined by the Norwegian Medicines Agency that sets pharmacy purchase prices (based on prices in other Northern European countries) and the Ministry of Health that sets pharmacy margins. A "discount sharing model" encourages pharmacies to perform parallel import and generic switching by allowing them to keep up to 50% of the difference between maximum price and actual price. The costs of pharmaceuticals in Norway are covered in part by the public budget and in part directly by the patient. Over one-half of pharmaceutical costs are borne by the Norwegian National Insurance Administration through the reimbursement scheme; membership in this program is mandatory, and costs are covered through taxes from employers and employees. Over 90% of reimbursed drug sales are accounted for by the established product list for general reimbursement, but supplementary reimbursement can be granted on the basis of individual patient applications and also to ensure that all patients with serious communicable diseases are given adequate treatment without costs to the patient (e.g., HIV/AIDS, tuberculosis). Patient copayment currently amounts to 36% of the total amount of prescriptions; the maximum per prescription is 48 euros, and total within a single calendar year is 180 euros. Copayments for physician visits, radiology examinations, and laboratory tests, can be included in this amount. The overall system is now undergoing reevaluation, as it has been criticized for being complicated and difficult to comprehend for the users.

Journal Article↗

Recertification: update and future issues.

This article describes the history and substance of New York State's proposal for a mandatory recredentialing program for physicians, its implications for the medical profession, and the pros and cons of instituting a recertification policy for ophthalmology.

Certification↗

Prenatal screening for illegal drugs. Dilemma for the nurse-midwife.

Prenatal screening for illegal drugs poses very complex ethical problems for the nurse-midwife who must make the decision whether to screen for illegal drugs and whether to report positive results to state child abuse investigators. We argue that the results of prenatal screening for illegal drug use should not be used for determination of child abuse and that the nurse-midwife should not be required to report the results of these screens for illegal drugs to state child protection agencies. It is far from clear that required reporting offers any benefit to the fetus or future child, and there are serious ramifications of reporting for the fetus, the pregnant woman, and the nurse-midwifery profession. However, we do argue that prenatal screening for both illegal and legal drug use should be encouraged and should be done as early as possible in the pregnancy. Prenatal screening for drugs should only be used by the nurse-midwife as a diagnostic procedure wherein standard informed consent and confidentiality restraints are maintained.

Child Abuse↗