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PubMed1988

Skin notation in the context of workplace exposure standards.

In the establishment of workplace exposure standards, the potential for cutaneous absorption is taken into consideration through the addition of "skin notation" to the relevant substance. In the TLVs Documentation (ACGIH, 1986) dermal lethal dose to 50% (LD50) or human data are the bases for the assignment of "skin notation" to 91 of 168 substances. For the other substances, the "skin" attribution seems to be based on undocumented statements in 24 (14.5%), skin effects in 13 (8%), and analogy in 7 (4%), while in the remaining 33 (20%) any reference is lacking as to the basis for notation of the cutaneous route of entry. Furthermore, since the established "cut-off" value of 2 g/kg is sometimes bypassed when a notation is added or omitted, the use of dermal LD50 is perplexing. Given the relevance of the skin notation for the validation of threshold limit values (TLVs) in the workplace, a full examination and citation of all available scientific data are recommended when establishing the TLV of substances absorbable through the skin.

Dermatitis, Occupational↗
PubMed2002

[Hepatitis B vaccination. Advocating for a protection principle].

Hepatitis B is a worldwide disease. More than 350 million persons are chronic carriers and around one-quarter of these chronic carriers will develop cirrhosis or liver cancer within 30 years. Since 1981, more than a billion doses of hepatitis B vaccine have been used worldwide and it is considered one of the safest vaccines ever produced. The suggestion of a link between hepatitis B vaccine and demyelinating diseases has arisen because of case reports, although inevitably some people will develop symptoms of demyelination by chance after receiving hepatitis B vaccine. Scientific data could never demonstrate a causal association between hepatitis B vaccine and central nervous system diseases, including MS. However, the hypothesis of a potential causal relationship between vaccination and multiple sclerosis (MS) and other demyelinating diseases was brought to public debate by the French Health Authority after the publication of these cases. Since 1998, in France, several court decisions held pharmaceutical companies responsible for the development of multiple sclerosis in patients who were given hepatitis B vaccine on two grounds: the chronological coincidence between vaccination and the development of the plaintiffs' MS, and the fact that a causal link between the two cannot be excluded, although the Appeals Court did declare that "it is indisputable that there is no definite scientific evidence of a relation between vaccination and the onset of the disease". On 1st October 1998, the French Minister of Health decided to stop hepatitis B vaccination in schools. Stopping immunization on the basis of unfounded worries has led to decreased vaccine coverage levels among children. Two recent studies published in the N Engl J Med in February 2001 confirm the lack of evidence of an association between hepatitis B vaccination and multiple sclerosis. The Académie nationale de Médecine should be consulted about this major public health issue.

France↗
PubMed1999

[Exposure to asbestos. Role of thoracic imagery in screening and follow-up].

Chest radiograph and computed tomography are the most appropriate imaging tools for detecting asbestos-related pleural and parenchymal disease due to their availability and performances. The cost and irradiation delivery of conventional chest X-rays are limited. Technical parameters and reading should be standardized. Digital chest radiograph will progressively replace conventional techniques but technical standards and performance data are lacking. Computed tomography, using spiral or conventional mode, explores the whole lung and pleura. High resolution computed tomography samples both lung and pleura but its sensitivity for parenchymal fibrosis detection is greater. Several methods can be employed and should be recommended to reduce radiation dose in spiral and high resolution computed tomography. Computed tomography is more sensitive and specific than chest radiograph in early detection of pleural plaques and parenchymal fibrosis but is not infallible. The error reading rate of chest radiograph for early detection of bronchial carcinoma is high. Computed tomography is more sensitive but lacks specificity and leads to detect a high rate of lesions the relation to asbestos exposure of which are difficult to establish. No scientific data are available to assess the contribution of imaging in early detection of mesothelioma.

Asbestosis↗
PubMed2000

Autoimmune lymphoproliferative syndrome. A human disorder of abnormal lymphocyte survival.

The importance of Fas in the homeostatic balance between lymphocyte survival and death is underscored by the three main consequences of defective Fas-mediated apoptosis, as experienced by patients with ALPS: (1) abnormal accumulation of lymphocytes results in lymphadenopathy, hepatosplenomegaly, and hypersplenism; (2) failure of removal of potentially autoreactive lymphocytes, a process normally used to eliminate lymphocytes that have escaped negative selection in the thymus and bone marrow (see article by Fleisher and Blessing, p. 1197), is associated with the appearance of autoimmune manifestations; and (3) inappropriate survival of lymphocytes may lead to the development of malignancies. As with other "experiments of nature," the many aspects of ALPS have provided valuable new insights into the immune system and the importance of a proper balance between life and death of lymphocytes. ALPS is an example of how a mouse disease model was applied directly to the identification of the molecular basis and the understanding of a remarkable disease in humans. It is also an example of clinical observations being linked to basic scientific data to unlock the underlying defect(s) causing a disease. Despite the difficulty in fully understanding the complex nature of the clinical course, the immunologic abnormalities, and the genetic aspects of ALPS, the accumulated experience in diagnosis, treatment, and follow-up of patients and relatives has generated a "road map" that can be used as a guide for their care. As examples, the appreciation that manifestations of lymphoproliferation usually subside over time has allowed a "wait-and-see" approach in many patients who might previously have been treated aggressively. The appreciation that these patients are at increased risk for malignancies has mandated the adoption of careful and lifelong follow-up. Future efforts directed at careful clinical follow-up and scientific investigation are required to learn more about the incidence and natural history of ALPS, therapeutic interventions directed at altering the consequences of TNFRSF6 mutations, and the identification of other genetic and environmental factors that may have a role in the pathogenesis of ALPS.

Apoptosis↗
PubMed1992

Trends in the pharmacologic treatment of insomnia.

Data from the National Disease and Therapeutic Index for the time period 1987-1991 (IMS, America) were examined for recent trends in the pharmacologic treatment of insomnia. All medications given with the desired action of promoting sleep or sedation at night were categorized as benzodiazepine hypnotics, benzodiazepine nonhypnotics, antidepressants, or other. From 1987 to 1991, the following trends were found: (1) overall pharmacologic treatment for insomnia decreased by approximately 10%, (2) use of benzodiazepine hypnotics fell about 30% during this time period, (3) use of antidepressants for insomnia increased by 100%, and (4) the noted changes were somewhat stronger for institutionalized patients than for ambulatory patients. These changes in the pharmacologic treatment of insomnia may be related to widespread media attention and are not supported by scientific data.

Adult↗
PubMed1990

Guidelines for medical practice: 2. A possible strategy.

The recognition that much current medical practice is based on incomplete scientific evidence has led to calls for the generation of guidelines for optimal patterns of practice. These guidelines must be developed from a synthesis of existing scientific data ideally obtained from randomized clinical trials. However, at present we may have to rely on less satisfactory data and the views of experts in the field. The primary purpose of these initiatives must be to improve patient care. The Ontario Medical Association has made recommendations on how such guidelines should be produced, and in a recent survey a substantial majority of family physicians supported them. There is general agreement that the coordinating body should be independent of government and other interested parties. In addition, the medical profession must have the primary role, and a number of medical organizations should also be represented. We propose a possible structure for a group charged with developing guidelines for medical practice at a provincial level and on an experimental basis. Recommendations are made on its membership, function and relationship with other organizations. The identification and diffusion of justifiable, scientific practice patterns will help reduce waste of scarce resources, maintain the role of the profession as guardian of the quality of care and ultimately benefit the patient.

Canada↗
PubMedDate not supplied

Estimated biological variation of the mature human milk fatty acid composition.

We estimated the biological variation (CV(biol)) of 28 fatty acids (FA) in 465 mature human milk samples from The Netherlands, Caribbean, Jerusalem, Tanzania and Pakistan, by using data from the observed variation (CV(obs)) and analytical variation (CV(anal)). CV(biol) of the various regions was remarkably similar. The average CV(biol) of 455 samples, Pakistan excluded, ranged from 12.7% for 16:0 and 18.9% for 18:1 omega 9 to 68% for 22:6 omega 3 and about 100% for 20:5 omega 3. Those of 20:4 omega 6, 18:2 omega 6 and 18:3 omega 3 were 28.0, 33.0 and 37.3%, respectively. Because of the large CV(biol) and the many dietary changes in recent history, it seems impossible to consider the present human milk FA composition as the 'gold standard' for infant formula. Optimal human milk FA composition should rather derive from populations that consume traditional diets or from the scientific data that show the function of the individual FAs in neonatal development.

Adult↗
PubMed1986

Regional Review Boards of Ontario: a medico-legal review.

The functioning of the Regional Review Boards of Ontario (RRB) or their equivalents in other provinces has not been previously reviewed. This study reviews socio-demographic and clinical data of 248 patients seen between 1974 and 1983 by the RRB. The RRB heard 132 applications as 116 were withdrawn. The results are compared with 173 matched inpatient controls. Applications by psychiatrists were infrequently withdrawn or revoked. Long delays between the time of application and the hearing, and a trend towards increasing numbers of applications were noted. Schizophrenia and affective disorder were the most prevalent diagnosis with alcohol abuse and organic brain syndrome being less common among applicants. An increase in duration of stay and transfer to chronic care institutions were found among applicants. Results suggest that RRB's are not 'rubber stamping bodies' and should be more readily available and should have increased public accountability. Future changes to the Mental Health Act should be based on scientific data.

Commitment of Persons with Psychiatric Disorders↗
PubMed1995

Paid-versus-volunteer blood donation in the United States: a historical review.

Several points are clear from this historical review. Over 50 years ago the first indications that hepatitis could be transmitted from the serum or plasma of one human to another became evident. This was confirmed in human transfer experiments although the agent causing hepatitis was not known and there was no specific test for what eventually was presumed to be a virus. It soon became clear that hepatitis was a complication of blood and plasma transfusion. Over the course of 10 to 20 years (the 1950s and 1960s) the connection was made between posttransfusion hepatitis and certain high-risk donors and behaviors. Despite the availability of scientific data to support the idea that not all commercial or paid blood donors were associated with higher rates of post-transfusion hepatitis, public opinion and emotions seemed to be a major driving force behind increased government regulation of blood banking. Because there were commercial blood banks that continued to recruit, collect, and pay blood donors from low-income, skid row areas, despite the mounting evidence that such donors clearly harbored higher rates of hepatitis, all commercial blood banks were reduced to that common denominator. Clearly economic factors were also being thrown into the equation. Political and philosophical differences between the major professional organizations involved in blood procurement and recruitment were important factors favoring more government control. The public pressured politicians and government agencies for more regulation and many scientific and medical professionals requested greater regulation. By the early 1970s the die was cast for increased regulation by the federal government.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Banks↗
PubMed1995

Local control of veins: biomechanical, metabolic, and humoral aspects.

The incidence of vein diseases (varicosity, thrombophlebitis, phlebosclerosis, orthostatic intolerance) is extremely high. In several countries it may exceed that of the arterial pathology by an order of magnitude. In the last decades, this recognition and the rapid accumulation of experimental data have resulted in a progressive reevaluation of the physiological significance of the venous system, which had been rather neglected earlier by scientists. The major aim of this review is to provide a critical survey of recent selected literature related to different physiological functions of the venous system as well as to biomechanical, metabolic, and humoral (ionic, hormonal) aspects of the local venous control. Local neural control mechanisms, including effects of catecholamines and other transmitters, are regarded to be beyond the scope of this work. At present, the synthesis of information available in the literature meets certain difficulties, because occasionally poorly defined methodological techniques and physiological parameters have been applied. On the other hand, a significant part of works dealing with venous physiology is excellent and inspirational. We have good reason to believe that the fast accumulation of reliable scientific data on this very important field will soon reach a new critical level, then an even more effective integration of knowledge will be possible.

Animals↗
PubMed2002

Pan-African sanctuary alliance: status and range of activities for great ape conservation.

While wild populations continue to decrease, the number of orphaned primates, sanctuaries, and attempts to reintroduce primates back to the natural environment are increasing. An umbrella organization called the Pan-African Sanctuary Alliance (PASA) was formed in 2000 and recently the IUCN Reintroduction Specialist Group developed a set of specific policy guidelines for primates (2002). Data presented in this report are based upon questionnaire responses by managers from 17 African facilities that have become members of PASA (membership in PASA is defined by attendance at an annual PASA workshop). These PASA facilities house over 500 great apes. (There may be other facilities not represented here simply because their managers did not attend a PASA workshop.) The majority of the apes arrived at the sanctuaries when they were less than 4 years old and half were confiscated. Over 40% were found awaiting sale, and 30% had been previously kept as pets. Common ailments upon arrival included internal parasites, behavioral abnormalities, and malnutrition; 20% of the total sanctuary population died prematurely. Most sanctuaries use a combination of enclosures surrounded by electric fencing and cages to accommodate the apes. Sanctuaries actively participate in conservation education, habitat protection, tourism, scientific data collection, local development, and reintroduction. The median total facility operating cost was 65,000 US dollars per annum. The median facility cost per ape was 2,222 US dollars per annum. Most funding comes from overseas nongovernmental agencies. Discussion focuses on evaluating the present status of sanctuaries, the problems facing them, and their potential role in African conservation issues.

Africa↗
PubMed2003

Nutrigenomics: the Rubicon of molecular nutrition.

The success of the Human Genome Project and the powerful tools of molecular biology have ushered in a new era of medicine and nutrition. The pharmaceutical industry expects to leverage data from the Human Genome Project to develop new drugs based on the genetic constitution of the patient; likewise, the food industry has an opportunity to position food and nutritional bioactives to promote health and prevent disease based on the genetic constitution of the consumer. This new era of molecular nutrition--that is, nutrient-gene interaction--can unfold in dichotomous directions. One could focus on the effects of nutrients or food bioactives on the regulation of gene expression (ie, nutrigenomics) or on the impact of variations in gene structure on one's response to nutrients or food bioactives (ie, nutrigenetics). The challenge of the public health nutritionist will be to balance the needs of the community with those of the individual. In this regard, the excitement and promise of molecular nutrition should be tempered by the need to validate the scientific data emerging from the disciplines of nutrigenomics and nutrigenetics and the need to educate practitioners and communicate the value to consumers-and to do it all within a socially responsible bioethical framework.

Biotechnology↗
PubMed2002

The age 60 rule: age discrimination in commercial aviation.

BACKGROUND: The Federal Aviation Administration's Age 60 Rule, promulgated in 1959, prohibits airline pilots from working in Part 121 operations once they have reached the age of 60. The Age 60 Rule remains a most contentious and politically sensitive topic, with challenges to the Rule currently mounted in both legislative and legal arenas. METHODS: An extensive review of the medical literature was accomplished using MEDLINE. Pertinent Federal Regulations were examined. Legal proceedings and public domain documents were noted. Letters and personal communication were solicited where necessary information could not be ascertained by other means. RESULTS: The Age 60 Rule was not based on any scientific data showing that airline pilots aged 60 and older were any less safe than younger pilots, and there is evidence to indicate that the choice of age 60 was actually based on economic rather than safety considerations. Airline pilots consistently exceed general population norms for longevity, physical health, and mental abilities. Fear of an adverse pilot health event causing a crash in standard multi-crew operations is not justified. For decades, airline pilots under age 60 have been granted the means to demonstrate their fitness for flying by taking medical, cognitive, and performance evaluations that are denied to airline pilots when they reach age 60. Actual flight experience demonstrates that older pilots are as safe as younger pilots. International aviation experience indicates that abolishing the Age 60 Rule will not compromise aviation safety. CONCLUSION: There appears to be no medical, scientific, or safety justification for the Age 60 Rule. As such, perpetuation of the Age 60 Rule, where age alone is used as the single criterion of older pilot fitness, represents age discrimination in commercial aviation.

Accidents, Aviation↗
PubMed2006

Why would laparoscopic gastric bypass patients choose open instead?

BACKGROUND: Laparoscopic Roux-en-Y gastric bypass (LRYGBP) has been demonstrated to be comparable to open Roux-en-Y gastric bypass (ORYGBP) surgery in randomized studies. Although a steep learning curve exists, laparoscopic bariatric surgery offers advantages if performed by an experienced bariatric surgeon. Despite these facts, some patients still choose to undergo ORYGBP. This investigation explored the reasons why patients who have had LRYGBP would decide to undergo the laparoscopic operation. METHODS: A survey was given to patients who had undergone LRYGBP. The survey was designed to ascertain what factors would influence them to have LRYGBP versus ORYGBP. Incomplete responses were not included in the data analysis. RESULTS: There were 41 patients who filled out the survey. Over 90% of the patients felt LRYGBP is better than open gastric bypass. There were 4 patients who had seen another surgeon who recommended ORYGBP. Approximately 61% (23/38) of the patients would have stayed with their surgeon even if their surgeon did not offer LRYGBP. In addition, 79% of patients (31/39) would have ORYGBP if their insurance did not cover LRYGBP. Most patients (67%) would have ORYGBP if their surgeon thought LRYGBP was experimental. If they were told that LRYGBP was too risky for them, 77% of patients (30/39) would have undergone ORYGBP. Only 15% of patients (6/40) would not have had surgery if LRYGBP did not exist. CONCLUSIONS: Patients are willing to undergo ORYGBP even if they believe that LRYGBP is better. Non-medical factors and/or surgeon recommendations instead of scientific data influence patient decision-making when choosing ORYGBP over LRYGBP.

Adult↗
PubMed2005

ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis.

The International Conference on Harmonization (ICH) stems from the initiative of three major world partners (Japan, USA, European Community) who composed a mutually accepted body of regulations concerning the safety, quality and efficacy requirements that new medicines have to meet in order to receive market approval. Documents on non-clinical safety pharmacology already composed by this organisation include two guidelines: the S7A adopted in 2000 and, its companion, the S7B guideline, in a draft form since 2001. The S7A guideline deals with general principles and recommendations on safety pharmacology studies designed to protect healthy volunteers and patients from potential drug-induced adverse reactions. The S7B recommends a general non-clinical testing strategy for determining the propensity of non-cardiovascular pharmaceuticals to delay ventricular repolarisation, an effect that at times progresses into life-threatening ventricular arrhythmia. In the most recent version of this document (June 2004), the strategy proposes experimental assays and a critical examination of other pertinent information for applying an 'evidence of risk' label to a compound. Regrettably, the guideline fails to deal satisfactorily with a number of crucial issues such as scoring the evidence of risk and the clinical consequences of such scoring. However, in the latter case, the S7B relies on the new ICH guideline E14 which is currently in preparation. E14 is the clinical counterpart of the S7B guideline which states that non-clinical data are a poor predictor of drug-induced repolarisation delay in humans. The present contribution summarises and assesses salient aspects of the S7A guideline as its founding principles are also applicable to the S7B guideline. The differences in strategies proposed by the various existing drafts of the latter document are critically examined together with some unresolved, crucial problems. The need for extending the objective of the S7B document to characterise the full electrophysiological profile of new pharmaceuticals is argued as this approach would more extensively assess the non-clinical cardiac safety of a drug. Finally, in order to overcome present difficulties in arriving at the definitive version of the S7B guideline, the Expert Working Group could reflect on the introduction of the S7B guideline recommendations in the S7A document, as originally intended, or on postponing the adoption of an harmonized text until the availability of novel scientific data allows solving presently contentious aspects of this and the E14 guidelines.

Arrhythmias, Cardiac↗
PubMed1993

Why different regulatory decisions when the scientific information base is similar?--Human risk assessment.

The main objective of this analysis has been to characterize the role of science, in a broad sense, in relation to social, economical, political, and other factors in explaining why regulatory decisions vary in different countries, although they are based on more or less identical scientific data. Eleven countries from different geographical areas and with varying cultural background have provided information in response to an extensive questionnaire aimed at identifying procedures for registration, restricting, or banning registration for certain selected pesticides. Although many of these responses lacked sufficient detail in certain aspects, together with other documentary sources they nonetheless provided insight with respect to some of the main concerns among and between nations regarding decisions in pesticide management. Among the main conclusions presented in this analysis, the following deserves particular emphasis: The underlying reasons for introducing restrictions on pesticide use on the national level will have to be more explicitly stated and openly declared by regulatory bodies of all nations. Although more pronounced in some countries, there is a strong influence of nonscientific considerations in pesticide management, that is not always based on rational considerations. In the field of hazard and risk assessment differences in scientific opinion have primarily, but not exclusively been identified regarding the evaluation of carcinogenic effects in experimental animals. In this area debated issues are the interpretation of the significance for man of certain types of tumors, methods for dose-response extrapolation, genotoxic versus nongenotoxic carcinogens, the use of MTD in long-term studies, mechanistic approaches to interpret cancer induction, and others. Another area identified to cause divergence is exposure assessment. Evaluation of pesticides on the national level for the purpose of regulation involves a tremendous duplication of efforts that could be substantially reduced by effective cooperation on the international level.

Environmental Health↗
PubMed2000

IUBMB updates Ph.D. standards.

The Education Committee of the International Union of Biochemistry (IUB, but IUBMB since 1991) published its report on "Standards for the Ph.D. Degree in Biochemistry and Molecular Biology" in 1989. Developments since then have led to the disappearance of the traditional demarcations between many of the biological disciplines, while information technology and bioinformatics have revolutionized the analysis, storage, and communication of scientific data. To meet these challenges, that report has now been revised through a broad interdisciplinary and international consultation. This has led to the recent publication, on behalf of the same Committee, of "Standards for the PhD Degree in the Molecular Biosciences". Like its predecessor this revised report not only defines in behavioural terms the qualities and skills expected of doctoral graduates by the international community of molecular bioscientists but also offers useful suggestions and advice as to how those skills can be developed and maximized. In addition, it discusses various topics related to doctoral education.

Biochemistry↗
PubMed2000

Alternating antipyretics: is this an alternative?

OBJECTIVES: To identify current fever management strategies and their basis, and to assess the frequency of alternating acetaminophen and ibuprofen. BACKGROUND: Practicing pediatricians confront the dilemma of elevated temperature and the anxiety this creates for parents. An informal survey of pediatricians revealed a variety of management strategies, including alternating acetaminophen and ibuprofen. There are no scientific data regarding alternating these 2 products. Design. During professional meetings, pediatricians voluntarily filled out a 15-item questionnaire. RESULTS: One hundred sixty-one completed surveys were reviewed. Respondents were mostly general pediatricians (67.7%), with >/=20 years in practice (55.9%). Most respondents chose a temperature of 101(o)F to start antipyretic treatment (61.9%). A small percentage used discomfort alone as the indication (13%). The antipyretic of choice was temperature-dependent in 50% of respondents; 57% used ibuprofen for temperature >/=102 degrees F. Fifty percent of respondents advised parents to alternate acetaminophen and ibuprofen. The method of alternation varied. The most common answers given for choosing a particular antipyretic regime were recommendations of the American Academy of Pediatrics (29%) and opinions of colleagues and mentors (25%). Physicians with <5 years of practice were significantly more likely to alternate antipyretics (69.7%). CONCLUSION: Acetaminophen and ibuprofen are commonly being used in an alternating manner for management of fever. There is presently no scientific evidence that this combination is safe or achieves faster antipyresis than either agent alone. There is evidence that the improper use of these agents may cause harm. Despite 29% of participants citing American Academy of Pediatrics recommendations as the basis for fever management, no such policy or recommendations exist. The observation that this practice is more common in younger practitioners may reflect their continued anxiety about fever (fever phobia). Until properly controlled studies have assessed the risk of combining these 2 products, practitioners should proceed with caution.

Acetaminophen↗