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PubMed2002

Fluoridation at fifty: what have we learned?

The question posed by the title of this article encompasses more than just the law and science applied to fluoridation. A review of the history and present status of fluoridation policy development and implementation makes it quickly apparent that the lessons learned are applicable to a wide range of public health policy and that the public health community needs to be very concerned about the status and trends of legal precedent. Indeed, in the context of recent U. S. Supreme Court decisions, the need for a comprehensive and coordinated effort to educate the public, legislators, and jurists about the safety and efficacy of community water fluoridation is clear. Two fundamental issues are at the core of this article: (1) the use of science in formulating and defending public health policy, and (2) how to connect scientific fact with the legal process in connection with the actual circumstances regarding a community's health status. The opening section of this article presents an analysis of fluoridation's great success in preventing dental caries over the past 50 years, along with a discussion of current data scientifically demonstrating that fluoride is safe when properly utilized. A second section provides an overview of one state's legislative experience in mandating fluoridation and the political challenges encountered. A final section discusses the legal issues associated with fluoridation, including the bases of legal challenges to public laws mandating it.

Dental Caries↗
PubMed2002

[Results of comprehensive data collection concerning urologic laparoscopy].

To evaluate the current status of laparoscopy, the "Working Group Laparoscopy" of the German Urological Association performed a questionnaire among urologists in Germany. Of 300 questionnaires 183 were returned and analyzed (61%): 54% of the departments already performed laparoscopy and another 50% are planning to introduce this technique. The major concerns are economical (70%), long learning curve (92%), investment (53%), and lack of scientific data (76%). Simple nephrectomy, cryptorchism, and varicoceles are treated by 66, 59, and 58 of the 96 departments laparoscopically (of 183 resp.). Laparoscopic surgery for radical prostatectomy and tumor nephrectomy is done by 32 and 34 of 96 departments. Only a minority of the centers performs more than 40 laparoscopies per year and indication. Compared to a survey conducted in 1995, the acceptance level of this technique has increased (100% vs 48%). Only a minority of the departments performs more than 40 laparoscopic interventions per year for one indication.

Attitude of Health Personnel↗
PubMed1994

Meta-analysis of the literature: guideline development for prostate cancer treatment. American Urological Association Prostate Cancer Guideline Panel.

Medical interventions are identified to be in need of practice guidelines based on several criteria, including uncertainty of therapeutic benefit, economic impact, variation in practice patterns and lack of objective data for new developments. Treatment of localized adenocarcinoma of the prostate meets these criteria and has been identified as an issue in need of practice guideline development. The American Urological Association began working toward establishing prostate cancer treatment guidelines in 1989. An explicit method based on collection of scientific data was adopted, which requires complete review of the literature and analysis of the evidence collected. An update on the progress toward this data analysis and guideline document is presented.

Adenocarcinoma↗
PubMed1996

Biotechnology and society: we scientists have responsibilities too.

When a new technology is introduced, scientists can help improve public understanding and acceptance. In the case of biotechnology, scientists should communicate more effectively: to provide accurate scientific data to facilitate policy analysis; to clarify issues in active political debate; to explain science to the lay public to dispel general ignorance and enable rational choice; to assist the media in producing more thoughtful journalism; to share expertise to allow beneficial applications in developing countries; and to advance scientific discovery.

Biotechnology↗
PubMed1995

A study of the angular dependence problem in effective dose equivalent assessment.

The newly revised American National Standard N13.11 (1993) includes measurements of angular response as part of personnel dosimeter performance testing. However, data on effective dose equivalent (HE), the principle limiting quantity defined in International Commission on Radiological Protection (ICRP) Publication 26 and later adopted by U.S. Nuclear Regulatory Commission (NRC), for radiation incident on the body from off-normal angles are little seen in the literature. The absence of scientific data has led to unnecessarily conservative approaches in radiation protection practices. This paper presents a new set of fluence-to-HE conversion factors as a function of radiation angles and sex for monoenergetic photon beams of 0.08, 0.3, and 1.0 MeV. A Monte Carlo transport code (MCNP) and sex-specific anthropomorphic phantoms were used in this study. Results indicate that Anterior-posterior (AP) exposure produces the highest HE per unit photon fluence in all cases. Posterior-anterior (PA) exposure produces the highest HE among beams incident from the rear half-plane of the body. HE decreases dramatically as one departs from the AP and PA orientations. The results also indicate that overestimations caused by using isotropic dosimeters in assessing effective dose equivalent from near-overhead and near-underfoot exposures are 550%, 390%, and 254% for 0.08, 0.3, and 1.0 MeV, respectively. Comparisons of the angular dependence of HE with those based on the secondary quantities defined in International Commission on Radiation Units and Measurements (ICRU) Reports 39, 43, and 47 show significant differences. This paper discusses why more accurate assessments of HE are necessary and possible. An empirical equation is proposed which can be used as the optimum dosimeter angular response function for radiation angles ranging from 0 degrees to 90 degrees for dosimeter calibration, performance testing, and design.

Dose-Response Relationship, Radiation↗
PubMed2002

Jayjock and Lewis reply.

The current state-of-the-science, in our opinion, is incapable of accurately predicting the human health risk at environmental exposures to chemicals. We believe that dose-response models represent an integral part of the scientific method but that all models require valid scientific data in the realm of actual exposure in order to be derived and function properly. Given this current state, the evidence to date and the promise of hormesis to provide a detectable signal at low-dose, we view it as a variable and valuable hypothesis worthy of significant scientific effort.

Animals↗
PubMed1997

Perineal dermatitis in the elderly. A critical review of the literature.

The review of literature revealed a significant lack of research on the pathogenesis of perineal dermatitis in the elderly. The majority of what is known about this condition stems from the pediatric population. The differences between TEWL and skin surface pH levels in pediatric and geriatric skin raises questions about the further generalizability of the pediatric studies. There appears to be some controversy in the literature regarding whether baseline TEWL is increased or decreased in cutaneous aging. The literature did reveal some data indicating that skin surface pH increases with age; however, no data on the perineum was found. No studies examining the role of TEWL and skin surface pH and its association in the development of perineal dermatitis in the elderly were found. Additionally, no studies were found that examine the nursing variables identified in the literature search. The paucity of scientific data on this serious and costly condition warrants additional research in this area.

Aged↗
PubMed1995

Using science to influence the Supreme Court on the right to refuse treatment: amicus curiae briefs in Washington v. Harper.

The Supreme Court's use of empirical behavioral science data has grown dramatically in the 40 years since Brown v. Board of Education. Most of these data are submitted in amicus curiae (friend of the court) briefs submitted by parties with an interest in the outcome of the significant mental health law cases coming before the court. The increasing use of such briefs raises important questions. Is there evidence that the court is actually influenced by such briefs? Can scientific/professional organizations present scientific data objectively in a clearly adversarial document? A review of the nine amicus briefs filed in Washington v. Harper, a right to refuse treatment case, and a comparison of the Court's opinion with that of the dissent demonstrate that both the majority and the dissent refer to arguments contained in the briefs, incorporate elements of these arguments, and occasionally paraphrase references cited in the briefs. It remains unclear whether the Court uses such arguments to formulate opinions or to justify them. A comparison of the briefs presented by the American Psychological Association and the American Psychiatric Association highlights the challenge to scientific objectivity inherent in participation in the amicus process.

Antipsychotic Agents↗
PubMed1998

Classification of childhood arthritis: a work in progress.

The classification of chronic childhood arthritis has challenged physicians for a century. Currently used classifications are all based on clinical characteristics and because they are frequently used imprecisely, communication of scientific data has been difficult. The new classification of the International League of Associations of Rheumatologists (ILAR) represents the results of an international effort to clarify the classification of this group of diseases based on identification of clinically homogeneous groups. This classification process is ongoing, and will reflect the results of scientifically based studies as they become available.

Arthritis, Juvenile↗
PubMed1999

Nursing presence. As real as a milky way bar.

Data sets from three individual studies on nursing judgment were reviewed from a wider perspective. This yielded meanings and phenomena not readily identified in the individual studies, and it was tentatively labeled presence. A hermeneutic study using 10 transcripts from each data set asked: What are the common features of the context of nursing judgment? and, What are the features of the nurses' connection with the patient that contribute to nursing judgment? The analysis yielded six features of nursing presence: uniqueness, connecting with the patient's experience, sensing, going beyond the scientific data, knowing (what will work and when to act), and being with the patient. These features of nursing presence are logical distinctions and serve as ways to grasp the idea of nursing presence.

Cues↗
PubMed2000

[Standards, Options and Recommendations (SOR): consequences of the SOR guidelines project in terms of liability for French Cancer Centers].

Context. The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centers (FNCLCC), the 20 French comprehensive Cancer Centers and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. Objectives. To identify consequences in terms of liability of the development of SOR guidelines and to formulate recommendations for the FNCLCC and medical doctors using SOR. Methods. Data have been identified by literature search on legal matters by CNEH's Legal Center JuriSanté, then submitted to a group of 8 experts. Results. The main conclusions of the present study are: 1)The SOR attest a high level of quality and methodological rigor; 2) according to legal considerations and in comparison to the available scientific data, the SOR guidelines can be considered as the state of the art in oncology at time of release; 3) the study identified six quality properties of Standards, Options and Recommendations (SOR): information contained in the SOR must be serious, accurate, reliable, complete, up-to-date and secure. The respect of these quality criteria is essential in the matter of liability; 4) when gathered, they can prevent the actors from being implicated on questions of liability. Specialists who use the SOR may avoid problems of liability, nevertheless evidence and the state of the art may evolve with time; 5) clinicians who do not use the SOR, may appear to be responsible for disasters, except if they can justify their medical decision (evolution of scientific knowledge or specific clinical circumstances, etc.); 6) therefore, SOR developers need to keep in mind these essential properties when SOR are prepared; 7) the SOR steering committee (COSOR) analysed the conclusions of the present legal study and defined a series of actions and procedures to guarantee the respect of the above quality criteria.

Clinical Competence↗
PubMed1993

Relationship between safety data and biocontainment design in the environmental assessment of fermentation organisms--an FDA perspective.

The Center for Veterinary Medicine requires strain/construct-specific data for recombinant fermentation organisms used in the production of animal drugs and feed additives. Fermentation plant biocontainment schemes are chosen based, in part, upon the ability of the organism to survive and persist in the environment and to transfer genetic information to indigenous organisms. Survival and persistence study methods may include one of the following ecosystems: activated sludge, mammalian gut, soil or river water. Gene transfer protocols can be incorporated into a persistence study. These studies are designed to show that the recombinant construct behaves similarly to the host in a representative ecosystem where the organism could be introduced inadvertently. The studies need to provide repeatable results and reflect current state-of-art design and methods. Data verification is conducted by FDA investigators during Good Laboratory Practice inspections. Biocontainment guidelines, such as those developed by the NIH Recombinant DNA Advisory Committee, set general biocontainment goals for large groupings of recombinant organisms. The FDA, as required under the National Environmental Policy Act, must base its decision making on verifiable scientific data specific to each application. Therefore, in addition to using these guidelines as benchmarks, sponsors are required to submit strain/construct-specific data to support the selection of an appropriate biocontainment level. Once additional well-controlled studies for a variety of constructs are available, broader generalizations as to biocontainment may be drawn.

Containment of Biohazards↗
PubMed2001

Radio frequency radiation exposure standards: considerations for harmonization.

Radio frequency radiation exposure standards vary in origin, development process, legal status, and in the actual exposure limits. To identify the sources of differences in limits, we evaluated technical aspects of eight standards that included supporting information on the scientific data and rationale. Comparisons were made among the standards by examining the scope of the underlying database, the rationales for safety factors and other issues underlying exposure limits in the energy-deposition range (0.1 MHz to 10.0 GHz) and in the surface-heating range (about 10 or 15 GHz to 300 GHz). The framework for this assessment was based on the methods recommended by the scientific and regulatory organizations for developing health-based exposure limits. General guidelines for performing risk assessments for threshold acting agents have been developed by the U.S. Environmental Protection Agency, Health Canada's Environmental Health Directorate, and the International Program on Chemical Safety of the World Health Organization. This general methodology was applied to radiofrequency radiation for this assessment. Because these methods strive to identify scientific issues and separate them from risk management or policy, they provide a basis for evaluation of standards in this paper. This distinction can provide a foundation for the longer-term goal of global harmonization of radio frequency radiation standards. Each of the standards evaluated in the energy-deposition range was found to use the same basic restriction, based on biological data and a 10-fold safety factor, yet explanations reflect different interpretations of the underlying biological data. Rationales differ for the magnitude of the safety factor, for the circumstances of exposure, for the nature of sensitive populations, and for the presumed health status of the individuals for whom the basic restriction is applicable. In the surface-heating range, broad variability in exposure limits are seen in the limit itself, as well as in the approach to time averaging and frequency dependence. Averaging times differ among standards, as do tissue geometries for defining partial-body exposures. The differences in approaches to develop the standards do not completely explain differences among the exposure limits, and methods for computing exposure limits from basic restrictions are not always defined. This analysis suggests harmonization of standards will require more detailed review and coordination of biological and engineering data and of policy options.

Canada↗
PubMed2006

Biomechanics and anterior cruciate ligament reconstruction.

For years, bioengineers and orthopaedic surgeons have applied the principles of mechanics to gain valuable information about the complex function of the anterior cruciate ligament (ACL). The results of these investigations have provided scientific data for surgeons to improve methods of ACL reconstruction and postoperative rehabilitation. This review paper will present specific examples of how the field of biomechanics has impacted the evolution of ACL research. The anatomy and biomechanics of the ACL as well as the discovery of new tools in ACL-related biomechanical study are first introduced. Some important factors affecting the surgical outcome of ACL reconstruction, including graft selection, tunnel placement, initial graft tension, graft fixation, graft tunnel motion and healing, are then discussed. The scientific basis for the new surgical procedure, i.e., anatomic double bundle ACL reconstruction, designed to regain rotatory stability of the knee, is presented. To conclude, the future role of biomechanics in gaining valuable in-vivo data that can further advance the understanding of the ACL and ACL graft function in order to improve the patient outcome following ACL reconstruction is suggested.

Journal Article↗
PubMed1985

Exercise and the primary prevention of cardiovascular disease.

Longitudinal population studies have consistently demonstrated an association between sedentary lifestyles and the incidence of coronary artery disease (CAD). Diverse lines of evidence from clinical and experimental studies further implicate physical inactivity as an important risk factor for CAD. The relation between physical inactivity and CAD appears to be curvilinear and independent of other major risk factors, but of lower magnitude. Several training-induced physiologic adaptations offer plausible mechanisms for the protective effects of physical activity. Extrapolation from available data indicates that exercise must be habitual, vigorous and continuous to provide protection from CAD. However, the observed association between inactivity and CAD could represent several hypotheses other than cause and effect. The need for an appropriately designed clinical trial is apparent, but such an endeavor is not feasible at present. Until more rigorous scientific data are available, judgment on the use of exercise in prevention of CAD must necessarily be based on the accumulation of evidence supporting the role of physical activity. The rationale for exercise in preventing the occurrence of CAD is reviewed.

Adult↗
PubMed1995

Pediatric critical care physicians' attitudes about guidelines for the use of ribavirin in critically ill children with respiratory syncytial virus pneumonia.

OBJECTIVE: To determine the attitude of pediatric critical care physicians concerning the use of ribavirin in children with respiratory syncytial virus lung disease in light of the revised American Academy of Pediatrics practice guidelines. DESIGN: A questionnaire was sent to 145 pediatric critical care doctors in the United States. MEASUREMENTS AND MAIN RESULTS: Seventy-seven percent of questionnaires were returned. The vast majority (91%) of the respondents think that the available literature does not support the Academy's recommendations for the administration of ribavirin to critically ill children with respiratory syncytial virus pneumonia. The largest single group of respondents (42%) does not usually prescribe ribavirin for these patients, but may be persuaded to use it by colleagues or consultants in individual cases. Twenty-six percent of all respondents stated that they do not use ribavirin at any time, even in severely ill patients with documented infection. Twenty-two percent of the respondents say that they will prescribe ribavirin, not because they believe it is efficacious, but because they believe the Academy guidelines compel them to do so as a standard of care. The respondents reported adverse effects of the drug, most notably exacerbations of bronchospasm (92%), far more often than the Academy document asserts. When solicited for general comments, the respondents were frequently concerned that critical care physicians were not involved in the development of the guidelines, the guidelines were based on a paucity of reliable data, and that the guidelines could put them at risk of malpractice litigation should they choose to not use ribavirin. CONCLUSIONS: Practice guidelines are increasingly being incorporated into patient care and quality improvement regimens, and it is imperative both that appropriate experts be included in their development, and that they be based on valid scientific data. The pediatric critical care community currently treats most of the severely ill patients with respiratory syncytial virus pneumonia. As a group, they remain unconvinced about the efficacy and safety of this drug, and many pediatricians are concerned about the ramifications of individualizing ribavirin therapy in their patients in light of the revised Academy recommendations.

Attitude of Health Personnel↗
PubMed2006

Formaldehyde as a potential human leukemogen: an assessment of biological plausibility.

The International Agency for Research on Cancer (IARC, 2004) recently reevaluated the epidemiological data on formaldehyde and concluded that there was "strong but not sufficient evidence for a causal association between leukaemia and occupational exposure to formaldehyde." This conclusion was tempered since a mechanism for leukemia induction could not be identified. Chemically induced leukemia is a well-studied phenomenon with benzene and a number of cancer chemotherapeutic drugs recognized as capable of causing this effect. Abundant in vitro and in vivo data in animals and humans demonstrate that exposure to sufficient doses of these recognized leukemogens can initiate a cascade of events leading to hematopoietic toxicity and the subsequent development of leukemia. This review addresses the biological plausibility that formaldehyde might be capable of causing any type of leukemia by providing a broad overview of the scientific data that must be considered in order to support or refute a conclusion that a particular substance might be leukemogenic. Data on benzene and selected chemotherapeutic cancer drugs are used as examples and are briefly summarized to demonstrate the similar biological events thought to result in leukemogenesis. These data are compared and contrasted with the available data on formaldehyde in order to judge whether they fulfill the criteria of biological plausibility that formaldehyde would be capable of inducing leukemia as suggested by the epidemiological data. Based on the epidemiological data, it is reasonable to expect that if formaldehyde was capable of inducing leukemia, in vivo and in vitro data would offer supporting evidence for biological plausibility. In particular, there is (1) no evidence to suggest that formaldehyde reaches any target organ beyond the site of administration including the bone marrow, (2) no indication that formaldehyde is toxic to the bone marrow/hematopoietic system in in vivo or in vitro studies, and (3) no credible evidence that formaldehyde induces leukemia in experimental animals. As discussed in this review, based on the key biological events that occur in the process of chemically induced leukemia, there is inadequate biological evidence currently available to corroborate existing weak epidemiological associations. This provides an insufficient database to conclude that there is a causal relationship for formaldehyde and leukemia risk.

Animals↗
PubMedDate not supplied

[Controversial or arguable therapies in neurodevelopmental disorders].

OBJECTIVE: To analyze the therapies and methods not scientifically documented that more frequently are offer and used for the treatment of neurodevelopmental disorders. DEVELOPMENT: These therapies are divided into three main groups: a) Therapies directed upon brain functioning; b) Therapies directed upon nutritional needs, and c) Others. Parents and close relatives of children with developmental disorders are vulnerable to any person, institution or method that offers a quick and easy solution to their problem. It is a priority that all health professionals are familiar with the unproven therapies, that are offered for the therapy of developmental disorders, so that they can inform, educate and advise correctly to parents and close relatives of their patients. To deal with unproven treatments involves more than analyzing the available scientific data. It is required a comprehension and understanding of the personal and family dynamics in front of a threat of illness or disfunction. CONCLUSION: Responsible and well informed parents in relation to an unproven therapy should be free and have the right to decide whether or not to use a controversial procedure prior to a scientific determination of its validity; they also must keep in mind that at least some procedures, beside of not been useful, could be harmful for the physical, emotional and economical well-being of the patient and/or his family.

Brain↗