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PubMed1987

Lack of effect of sucralfate on prednisone bioavailability.

The relative bioavailability of single oral doses of prednisone with and without sucralfate administration was determined in 12 healthy male volunteers. Each subject participated in a randomized three-way cross-over study consisting of the following three phases: treatment A, prednisone given alone; treatment B, 2 days pretreatment with sucralfate with a concomitant dose of sucralfate administered with prednisone; and treatment C, 2 days pretreatment with sucralfate with a sucralfate dose administered 2 h after the oral prednisone dose. Plasma prednisolone concentrations (active moiety of prednisone) were determined by a specific and sensitive high-performance liquid chromatographic assay and unbound prednisolone concentrations were determined by equilibrium dialysis. Bioavailability was assessed by comparing the areas under the plasma prednisolone concentration-time curves as well as peak concentrations, time to peak concentration, elimination rate constant, and half-life. No significant differences were noted in any of the treatment phases for any of the parameters except for the time of peak concentration which was slightly delayed from 1.0 +/- 0.6 to 1.7 +/- 0.9 h when sucralfate was concomitantly administered with the prednisone. Thus, the data from this study indicate that sucralfate does not have a clinically significant effect on the bioavailability of orally administered prednisone. The use of these two drugs in combination does not result in an interaction requiring dosage regimen alteration.

Adult↗
PubMed2003

The David Jayne amendment: the story of one man's determination to improve the lives of thousands.

Stricken by ALS at the age of 27, David Jayne slowly lost the ability to walk, to eat, to speak, and to breathe. With the assistance of home health professionals, medical technologies, and volunteers, he has managed to maintain as full a life as possible, participating in some of his children's activities and even managing, with great effort, to attend a football game. However, when he was the subject of a newspaper article, his home health coverage was dropped because he didn't meet the federal definition of "homebound." This is the story of how he took on the political establishment single-handedly, and eventually realized a victory that has the potential of helping thousands of people in similar situations to no longer be imprisoned at home.

Adult↗
PubMed1994

House subcommittee rejects effort to remove abortion coverage.

On May 12, (1994) a subcommittee of the House Education and Labor Committee voted 16-11 in support of retaining abortion coverage in the President's proposed health care plan. With its vote, the Labor/Management Relations subcommittee rejected an amendment by Representative Ron Klink (D-PA), which would have allowed insurers to cover abortions only in cases of forcible rape or incest, or life endangerment. Two Republican Representatives joined 14 Democrats voting against the amendment, while 3 Democratic Representatives were among the 11 people supporting the Klink amendment. The subcommittee also defeated an amendment introduced by Representative Dick Armey (R-TX), which would have prohibited any language in a health care reform bill from overruling constitutional state laws restricting abortion. 14 subcommittee members voted against the Armey amendment; 11 voted in favor. The subcommittee is not expected to act on a final health care measure before the Memorial Day recess. In related news, a Veterans' Affairs House subcommittee voted 11-8 on May 11 to prohibit the performance of abortions at Department of Veterans' Affairs Hospitals or the coverage of abortion services by VA funds. The amendment was introduced in the Hospitals and Health Care subcommittee by Representative Chris Smith (R-NJ). Neither subcommittee action represents a final decision on abortion coverage in health care reform and none of the 5 Congressional committees considering health reform is expected to finalize their proposals before the Memorial Day recess. The Senate Labor and Human Resources Committee and the House Ways and Means Committee started work on health care reform on May 18. The Senate Finance Committee has only been meeting privately thus far, while neither the full House Education and Labor Committee nor the House Energy and Commerce Committee has met.

Abortion, Induced↗
PubMed1987

Reproductive Health Services v. Webster, 17 March 1987, amended on 30 April 1987.

The plaintiff physicians and organizations providing abortion-related services challenged the constitutionality of provisions of a Missouri statute that a) state that life begins at conception and that unborn children have a protectable interest in life, health, and well being; b) require a physician to inform a woman seeking an abortion of certain facts; c) require all post sixteen-week abortions to be performed in a hospital; d) require certain tests to be performed in order to determine gestational age and viability; and e) prohibit the use of public funds, public employees, and public facilities for performing or assisting an abortion or encouraging or counseling an abortion except to save a woman's life. The Court ruled that all of these provisions were unconstitutional and in conflict with its previous rulings on a woman's right to obtain an abortion. In a related case the United States District Court, E.D. Missouri, E.D., held that the plaintiff physicians could not attack a statement of intent of the same law, which provides that "It is the intention of the general assembly of the state of Missouri to grant the right to life to all humans, born and unborn, and to regulate abortion to the full extent permitted by the Constitution of the United States, decisions of the United States Supreme Court, and federal statutes." See Women's Health Ctr. of West Cty. v. Webster, 24 September 1987, 670 F.Supp. 845.

Abortion, Induced↗
PubMed2004

The responses of selected terrestrial plants to short (<12 days) and long term (2, 4 and 6 weeks) hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) exposure. Part I: Growth and developmental effects.

Soils contaminated with explosive materials like hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) is a concern nation-wide on military installations and sites where explosives are manufactured, stored, or disposed. Terrestrial plants are a vital group of receptor organism, yet limited published information is available on the potential impacts of RDX exposure in terrestrial plants. This research comprised the initial phases in the development of a short-term (<12 days) screening experiment for assessing the environmental impacts of RDX exposure in terrestrial plants. Fifteen plants (dicots and monocots) were exposed to three soils amended with 0-4000 microg g(-1) of RDX during the short-term screening experiments. Growth responses (maximum root and shoot lengths, percent emergence) and adverse developmental effects were the assessment endpoints. Sunflower was identified as the most RDX sensitive plant and selected for evaluation during the long-term (2, 4, and 6 weeks) experiments. Two life stages of sunflower (embryos and 2-week old seedlings) were exposed to Grenada soil amended with 0-100 microg g(-1) of RDX. The assessment endpoints during the long-term experiments included: biomass, maximum shoot and root length, root bio-volume, maximum stem diameter, number of leaves, and adverse developmental effects. Statistically significant differences were measured in several of the growth parameters following the short and long term exposure studies, however there were no consistent patterns. The consistent indicators of detrimental impacts from RDX exposure were the adverse developmental effects observed, regardless of life stage, soil type, or exposure duration. Typically, more adverse developmental effects were observed in dicots than monocots. The efficacy of the short-term screening experiments for estimating the impacts of long-term RDX exposure was validated.

Hazardous Waste↗
PubMed1985

Right to refuse treatment with psychotropic medication.

The law regarding refusal of psychiatric patients to take psychotropic medication is reviewed. The law in this area is traced through its evolution beginning in the 1960s when failure to administer medication to psychiatric patients was considered mistreatment of the patient. The legal basis for forcible administration of drugs is reviewed, and a discussion of cases in which patients refused to accept treatment on religious grounds is presented. When children are involved, the courts are generally in accord that the parents' right to freedom of religion ends where the child's right to life begins or when there is a threat to public health and safety. In cases involving adults, without a threat to public health or safety, relevant opinions rule that medical treatment should not be ordered against the patient's religious beliefs because it would constitute a violation of the First Amendment. Two leading cases involving the forcible administration of medication, Rennie v. Klein and Rogers v. Okin, held that administration should be limited to emergency situations when there is substantial risk of injury to the patient or others in the hospital. The Supreme Court made it clear that the right to refuse must be derived from state law, not from the federal Constitution, apparently giving health-care professionals broad leeway in exercising professional judgment in this area.

Humans↗
PubMed2005

Optimizing chemotherapy for advanced non-small cell lung cancer: focus on docetaxel.

Systemic chemotherapy with platinum-based combinations provides modest improvements in both survival and quality of life for patients with advanced non-small cell lung cancer (NSCLC). For first-line treatment of advanced NSCLC patients with a good performance status, the accepted standard of care is a platinum agent combined with docetaxel, paclitaxel, gemcitabine, vinorelbine or irinotecan. Several studies have attempted to identify an optimal platin-based regimen, however, all regimens offer some combination of clinical benefit with characteristic toxicities and no regimen appears clearly superior. Non-platinum regimens have also shown equivalent efficacy compared to platinum combinations, but again, none are clearly superior. Most recently, the existing standard of care is being amended to reflect the survival advantage gained from adding a new targeted agent, bevacizumab, to traditional platinum-doublet therapy for patients with non-squamous NSCLC. Docetaxel is the only agent currently approved for both first- and second-line treatment of advanced NSCLC. Multiple randomized clinical trials have established the efficacy of platin-docetaxel regimens for first-line treatment of advanced NSCLC. Improvements in various lung cancer related symptoms and global quality of life indices have also been noted with docetaxel-based regimens. Based on the efficacy of platin-docetaxel regimens in advanced disease, they are now being incorporated into the adjuvant and neoadjuvant treatment of early-stage disease.

Adult↗
PubMed1994

Federal regulation of experimental animal use in the United States of America.

The author outlines the regulation of animal experimentation in the United States of America (USA). Regulation in this field is at the developmental stage; issues are still being defined as public interest in animal welfare focuses on various aspects of animal science. Society continues to initiate regulations for animal experimentation in response to technological advances which were unknown when the first USA Federal legislation in this field (the Laboratory Animal Welfare Act) was signed in 1966. Under the sponsorship of animal welfare activists and, more recently, animal rights advocates, amendments to the 1966 law have increased the scope of Federal authority by extending both the number of species covered and the areas of care which are regulated. A greater awareness has evolved of the issues raised by animal experimentation, both among the general public and within the scientific communities. The importance of the Institutional Animal and Care Use Committees in research facilities is described, together with other factors which affect Federal legislation. Government regulatory philosophy is also changing towards a participatory relationship between regulators and public interest groups. Various affiliations to global and regional organisations have heightened national awareness with regard to the perceived exploitation of animal species. The author demonstrates clearly that the prevailing trend in the USA is towards expanded agreements which are jointly derived and implemented, and which will be instrumental in the search for resolutions. The author concludes that these resolutions will continue to revolve around the ethical need to respect the nature of animal species and the need for knowledge concerning both humans and animals which can help to extend and enhance the quality of life.

Analgesia↗
PubMed1994

Polychlorinated biphenyls (PCBs) in the British environment: sinks, sources and temporal trends.

This paper estimates the present UK environmental loading of polychlorinated biphenyls (PCBs). Of the estimated approximately 40,000 t SigmaPCB sold in the UK since 1954, only an estimated 1% (400 t) are now present in the UK environment. Comparisons of estimated production and current environmental loadings of congeners 28, 52, 101, 138, 153 and 180 suggest that PCB persistence broadly increases with increasing chlorination. Those PCBs that are not now present in the UK environment are considered to have been destroyed--by natural or anthropogenic mechanisms, to be still in use, to reside in landfills or to have undergone atmospheric and/or pelagic transport from the UK. The dramatic fall in PCB levels in archived UK soils and vegetation between the mid-1960s and the present is evidence that the latter mechanism is the most important and that a significant proportion of PCBs released into the UK environment in the 1960s have subsequently undergone environmental transport away from the UK. The bulk (93.1%) of the estimated contemporary UK environmental burden of SigmaPCBs is associated with soils, with the rest found in seawater (3.5%) and marine sediments (2.1%). Freshwater sediments, vegetation, humans and sewage sludge combined account for 1.4% of the present burden, whilst PCB loadings in air and freshwater are insignificant. Although consideration of individual congeners does not reveal any major deviations from the relative partitioning of Sigma PCBs, the importance of sinks other than soils is enhanced for individual congeners, particularly 138 and 180. In particular, around 2% of the total UK burden of congener 180 is present in humans, implying that biodata as a whole may constitute an important sink for the higher chlorinated congeners. The contemporary flux of SigmaPCBs to the UK surface is estimated at 19 t yr(-1), compared with an estimated annual flux to the atmosphere of 44-46 t. This implies that the major sources of PCBs to the UK atmosphere have been identified and that there is currently a net loss of these compounds from the UK. These sources are: volatilisation from soils (88.1%), leaks from large capacitors (8.5%), the production of refuse-derived fuel (RDF) (2.2%), leaks from transformers (0.6%), the recovery of contaminated scrap metal (0.5%) and volatilisation from sewage sludge-amended land (0.2%). Interestingly, whilst large excesses of estimated annual fluxes to the atmosphere over deposition fluxes for individual congeners exist for congeners 28, 52 and 101, estimates of fluxes in both directions across the soil-atmosphere interface agree closely for congeners 138, 153 and 180. This suggests that lower chlorinated congeners are more susceptible to both long-range environmental transport beyond the UK and to atmospheric degradation. Retrospective analysis of dated sediment cores, vegetation and soils indicates that environmental transport from North America and continental Europe introduced PCBs into the British environment well before the onset of their commercial production in the UK in 1954. Since that time, the input of PCBs to the UK environment has essentially reflected temporal trends in UK use. After peaking in the 1960s they declined rapidly through the 1970s following restrictions on PCB use. Recent evidence, however, is that the rate of decrease has diminished and that further significant reductions in fresh environmental input will take some time to occur. Such reductions will be especially slow for humans and other biota with long life-spans. This stems partly from cross-generational transfer from parents to offspring and also because the persistence of PCBs in biota means that present body burdens will reflect past as well as current exposure.

Journal Article↗
PubMed1995

Assisted suicide and the savings clause.

In December 1994, the Michigan Supreme Court decided a group of cases comprising constitutional challenges to a Michigan statute against assisted suicide and prosecutions of Dr. Jack Kevorkian for his role in two incidents of suicide. The court rejected arguments that the statute infringed a right of "personal autonomy" under the Fourteenth Amendment to the US Constitution; it noted that, although US Supreme Court opinions indicate that decisions to withdraw or reject life-sustaining treatment are constitutionally protected, a legal difference exists between permitting death to occur by natural means and taking affirmative steps to end life. The Michigan court also decided that Kevorkian could not be charged with murder for supplying only the means by which suicide occurred, but he could be charged with a common law crime of assisting in suicide although the statute outlawing such actions became effective only after the suicides occurred. Because suicide was a crime under the prerevolutionary English Common Law, which forms the foundation of Michigan law, assisting in suicide is also a residual crime under the "savings clause" of the Michigan statutes, which incorporates common law crimes into the law of that state when no superseding statute exists.

Criminal Law↗
PubMed1982

Requirements applicable to sterilizations (hysterectomies)--Health Care Financing Administration. Final rule.

Current Department regulations for the Medicaid and Public Health Service programs provide that no Federal funds are available for hysterectomies unless the woman or her representative has signed an acknowledgment that she was informed that the operation would make her sterile. These amended rules eliminate the "acknowledgment requirement" in certain situations where the patient is already sterile or a life-threatening emergency situation exists. The regulations also clarify certain ambiguities. The purpose of these regulations is to remove an unnecessary administrative burden created by the current requirements. The regulations also reinstate a cross-reference, which makes the Medicaid sterilization requirements applicable to the social services block grant. This cross-reference was inadvertently deleted in an earlier publication. States may choose to make the provisions retroactive to March 8, 1979 or any date thereafter through the date of publication of these regulations. These rules may also be effective retroactive to March 8, 1979 or any date thereafter through the date of publication of these regulations for the PHS programs they apply to.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1989

Baby Doe, Congress and the states: challenging the federal treatment standard for impaired infants.

In its amendments to the Child Abuse Prevention and Treatment Act, Congress set forth a strict standard for treatment of impaired infants. The statute, shaped by right-to-life groups and certain medical organizations, calls for aggressive treatment in virtually all cases, regardless of the degree of suffering imposed and the burdens and risks involved. The federal rule evidences deep distrust of parental decisionmaking, relegating most parents to a nonparticipatory bystander role. Congress did not make its rule binding on the states. Rather, it conditioned the receipt of federal funds upon incorporation of the rule into each state's law. Most states have accepted the condition, largely through rulemaking by state child abuse agencies. This article challenges the authority of state administrators to promulgate these rules, and argues that state constitutions, little mentioned in the Baby Doe debate thus far, may prohibit many states from adopting the federal standard. Ordering medical interventions that perpetuate extreme conditions of physical and mental devastation, subjecting infants to grave suffering for uncertain benefits, and depriving parents of virtually all decisionmaking power violates the norm of governments constitutionally committed to individual liberty, human dignity and family autonomy. A constitutionally sound approach to this issue would permit careful, ethical deliberation, attention to the individual circumstances of each infant Doe and a reasonable degree of parental control.

Child Abuse↗
PubMed2001

Effects of epoetin alfa on hematologic parameters and quality of life in cancer patients receiving nonplatinum chemotherapy: results of a randomized, double-blind, placebo-controlled trial.

PURPOSE: This randomized, double-blind, placebo-controlled clinical trial assessed the effects of epoetin alfa on transfusion requirements, hematopoietic parameters, quality of life (QOL), and safety in anemic cancer patients receiving nonplatinum chemotherapy. The study also explored a possible relationship between increased hemoglobin and survival. PATIENTS AND METHODS: Three hundred seventy-five patients with solid or nonmyeloid hematologic malignancies and hemoglobin levels < or = 10.5 g/dL, or greater than 10.5 g/dL but < or = 12.0 g/dL after a hemoglobin decrease of > or = 1.5 g/dL per cycle since starting chemotherapy, were randomized 2:1 to epoetin alfa 150 to 300 IU/kg (n = 251) or placebo (n = 124) three times per week subcutaneously for 12 to 24 weeks. The primary end point was proportion of patients transfused; secondary end points were change in hemoglobin and QOL. The protocol was amended before unblinding to prospectively collect and assess survival data 12 months after the last patient completed the study. RESULTS: Epoetin alfa, compared with placebo, significantly decreased transfusion requirements (P =.0057) and increased hemoglobin (P <.001). Improvement of all primary cancer- and anemia-specific QOL domains, including energy level, ability to do daily activities, and fatigue, was significantly (P <.01) greater for epoetin alfa versus placebo patients. Although the study was not powered for survival as an end point, Kaplan-Meier estimates showed a trend in overall survival favoring epoetin alfa (P =.13, log-rank test), and Cox regression analysis showed an estimated hazards ratio of 1.309 (P =.052) favoring epoetin alfa. Adverse events were comparable between groups. CONCLUSION: Epoetin alfa safely and effectively ameliorates anemia and significantly improves QOL in cancer patients receiving nonplatinum chemotherapy. Encouraging results regarding increased survival warrant another trial designed to confirm these findings.

Activities of Daily Living↗
PubMed1994

State legislative approaches to regulating coverage for experimental procedures.

As addressed in past issues of the Newsletter, the Employment Retirement Income Security Act ("ERISA"), 29 U.S.C. sections 1001 et seq., limits the ability of states to regulate the terms and conditions of group health plans. See Newsletters, Vol. 8, No. 6, June 1993, at 6 and 23; Vol. 8, No. 1, January 1993, at 7; Vol. 7, No. 2, February 1992, at 13; Vol. 6, No. 11, November 1991, at 3. Under ERISA, states cannot mandate that self-insured group health plans or employers provide specific types of coverage. Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724, 105 S.Ct. 2380 (1985). Such mandates are enforceable only as to insurance companies and HMOs, and only to the extent that they are deemed to "regulate insurance." Id. As a result, state legislative attempts to regulate experimental treatment insurance coverage have largely been limited to health plans that are not self insured. Given the inconsistent handling of experimental treatment insurance coverage by both insurance companies and courts across the nation, state legislatures have demonstrated that they are ready to address this matter themselves. However, unless ERISA is amended to afford employees with self-insured plans the same protections as those with insured plans, such state efforts will not be able to resolve the problem for all citizens.

Bone Marrow Transplantation↗
PubMedDate not supplied

[Maternal allegations for weaning: qualitative study].

OBJECTIVE: To study the reasons for weaning given by women receiving care at a Baby-Friendly Maternity in Teresina, state of Piauí, Brazil. METHODS: The methodological principles of qualitative research were applied, supported by the social representation theory. Data were collected from 24 women who were in the process of weaning their babies before the 4th month of life. RESULTS: The decision-making process that leads women to wean their babies is complex and guilt-ridden. The following reasons for weaning were mentioned: having weak or little milk; puerperal problems affecting the breasts; lack of experience; disparity between the needs of the mother and the needs of the baby; external factors; work; ambiguity between wish/capacity to breastfeed and between burden/desire. CONCLUSIONS: A sense of solitude/isolation on the part of the mother and the need for support, not only from health services, but also from other segments of society, were conveyed in all interviews. The model of health care providing should be amended so as to treat breastfeeding as an act to be learned by women and protected by society.

Breast Feeding↗
PubMed1990

[Sterilization of the mentally handicapped according to section 1905 of the German Civil Code in relation to developing a patient management regulation].

Discussions on the sterilization of the mentally handicapped are still overshadowed to a great extent by the dire consequences of National Socialist policies which were only poorly concealed in the legislation of the period. These laws have meanwhile been rescinded but that has not eradicated the phenomenon itself. In fact, in recent years about 1,000 mentally handicapped persons have been sterilized--without their consent and without any firm legal basis for such action--shortly before reaching the age of 18. In most cases, the parents and the physicians involved joined forces in taking the matter into their own hands. Against this background there is a clear need for legislative action. Virtual agreement has been reached on this between the political groupings represented in the Bundestag and the organizations working for the welfare of the handicapped. Nonetheless, the recently submitted draft of a new bill is for the most part unacceptable. It is an improvement of earlier drafts in asmuchas the attempt to establish a close and often inappropriate link with Sect.218 a of the Penal Code (concerning abortion) has at least partly been given up. But the fact remains that handicapped women are still subjected to greater burdens than their male counterparts. Under the planned amendment to Sect.1905 Para. 1 (4) of the Civil Code, the act itself will define the requirements for a sterilization to be carried out "for medical reasons" (i.e. if life or health of the expectant mother are in jeopardy). Sect.1905 of the Civil Code contains no specific regulations as to when a sterilization is permissible "for eugenic reasons," but the fact remains that it can still be quite easily carried out under the general grounds. Pursuant to Sect.218a of the Penal Code an abortion can be exempt from punishment under special circumstances (i.e. on "social grounds") if the mother is at the time in a desperate situation which cannot be rectified in any other way. It certainly reflects very poorly on us if we do not succeed in giving the handicapped the help and support they need in their life situations which are so completely different from ours.

Child↗
PubMed1995

The compulsory removal of elderly people in England and Wales under Section 47 of the National Assistance Act and its 1951 Amendment: a survey of its implementation in England and Wales in 1988 and 1989.

Section 47 of the National Assistance Act 1948 and its 1951 Amendment allow for the compulsory removal from their homes of predominantly elderly people to a place of safety. The Amendment has been in use for over 40 years. Little information is available on the workings of the Acts in England and Wales. For the period 1988 to 1989 inclusive, 771 requests for compulsory removal were received by 148 'proper officers'. We examined referrals and removals under the Acts. During this time 165 people were removed. The majority of referrals were from family practitioners (46%), but social workers also played a role (18%). Of the 165 people who were actually removed from their homes, 41 were removed under Section 47 of the National Assistance Act and 124 under its 1951 Amendment. The outcome of compulsory removal was only known in 126 instances. In 34% of cases the person was transferred to residential care and 24% returned home; 18% of the detainees died during their compulsory admission. The outcome varied significantly between health regions (chi 2 = 72; p < 0.001), with for example apparently high death rates in the North West, Trent and South West regions. For a disturbing 24% of people nothing is known of their fate. A mandatory reporting system to examine the use of this legislation is required.

Activities of Daily Living↗
PubMed1989

[Atresia of the left coronary ostium. Repair in a 2-month-old infant].

A case of atresia of the left coronary ostium revealed by neonatal heart failure is reported. The initial diagnosis was anomalous origin of the left coronary artery from the pulmonary artery. At surgery performed in this 6-week old infant the diagnosis was amended and the malformation was repaired. Soon after the operation the child rapidly developed hypertrophic "myocardiopathy" of the left ventricle. Seven and a half months later, he is asymptomatic and the echocardiographic parameters of left ventricular systolic function are gradually returning to normality. Atresia of the left coronary ostium is an exceptional anomaly which must be considered, together with the other anomalous origins of the left coronary artery, when confronted with a case of severe heart failure caused by coronary ischaemia during the first months of life. The diagnosis rests on opacification of the coronary network during cardiac catheterization. Coronary "revascularization" may be performed either by aortocoronary bypass or by anatomical repair of the malformation.

Angiocardiography↗