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PubMed2003

Potential human cancer risks from exposure to PCBs: a tale of two evaluations.

In 1999 the Agency for Toxic Substances and Disease Registry (ATSDR) released a Draft Toxicological Profile for Polychlorinated Biphenyls (PCBs). In reviewing the potential human carcinogenicity of PCBs, ATSDR (1999) concluded that "The weight of evidence does not support a causal association for PCBs and human cancer at this time." Just 1 year later, in an updated Toxicological Profile for Polychlorinated Biphenyls (PCBs), the conclusions of another analysis (ATSDR, 2000) on whether exposure to PCBs might represent a carcinogenic risk to humans had dramatically changed to "Overall, the human studies provide some evidence that PCBs are carcinogenic" and "some of these studies provide meaningful evidence that PCBs are carcinogenic in humans." Because this is a substantially different conclusion than that reached only one year previously, it raises a number of questions that must be considered particularly since "weight of evidence" has a precise meaning in the context of evaluating a body of epidemiological data. The present review addresses the additional scientific data that became available between the ATSDR 1999 and 2000 evaluations that was of a magnitude to offset the weight of evidence from numerous epidemiological studies that exposure to PCBs was not causally associated with human cancer to a conclusion only 1 year later that there was now "meaningful evidence" that PCBs posed a carcinogenic risk to humans. Also of interest are the criteria upon which this conclusion is based and the distinction between "weight of evidence" and the newer descriptors of "some evidence" and "meaningful evidence." However, as shown in this review, only one relevant study was published between the ATSDR 1999 and 2000 evaluations and the results of this study were unequivocally supportive of the 1999 conclusion. Because of the continuing controversy surrounding this issue, in this review, all relevant epidemiological data on PCBs are summarized and subjected to another weight of evidence evaluation. This critical review is based on the most recent guidelines (U.S. EPA, 1999a, 2003) for conducting weight-of-evidence evaluations on a body of epidemiological data. Applying a weight-of-evidence evaluation to the PCB epidemiological studies can only lead to the conclusion that there is no causal relationship between PCB exposure and any form of cancer, thereby confirming the conclusions of ATSDR (1999). Also considered is the methodology and logic used by ATSDR (2000) that resulted in overturning the weight of evidence conclusions concerning the human carcinogenicity of PCBs in ATSDR (1999). This issue may have public health and policy implications. It seems appropriate that unbiased evaluations of a body of data, even of controversial issues such as the potential human carcinogenicity of PCBs, be conducted in a transparent manner following applicable guidelines. The dramatic differences between the conclusions of ATSDR (1999) and ATSDR (2000) do not appear to be consistent with this process.

Animals↗

PubMed1987

[Therapeutic modalities applied to tuberculotics in the Rhône Department in 1982].

Four hundred tuberculous patients who had been recorded in the register of the Rhône department during 1982 were retrospectively investigated for treatment procedures (hospital care and drug regimen); 89 had to be excluded: 42 died during treatment, in 30 the initial diagnosis was no longer maintained, 17 were lost to follow up. Hospital admission was required in more than 91% patients and 60% patients were sent to sanatoria. The duration of hospital care varied with the physician (university or not, pneumologist or not), the disease (localization, bacteriology) and the patients: the shortest duration was seen in young North African women, the longest in maghrebian men. Compared with "official recommendation" chemotherapy is usually prescribed for longer than necessary (mean treatment duration: 11 months. Ethambutol prescription for 8 months). These data illustrate the usual gap seen between "scientific" data given by controlled trials and routine practice.

Adolescent↗

PubMed1995

The dissemination of false data through inadequate citation.

OBJECTIVES: That occupational exposure to mercury causes reproductive failure in dental personnel has been propagated by repeated reference to a single epidemiological study in Poland, published in 1987. The present paper scrutinizes the results of this study, and monitors its subsequent citation in the literature. METHOD: Articles referring to the study were located in the Science Citation Index. From references in these papers and through other references, further articles were found. These papers were reviewed, and their content organized in relation to the way in which the Polish study was cited. RESULT: Most authors referred to the findings in the Polish study without critical evaluation of the data presented. CONCLUSIONS: Citation of irrelevant or misleading scientific data in the literature raises unfounded concerns in nonscientific circles and may lead to unwarranted regulations. It is therefore essential that editors and reviewers of scientific articles also scrutinize the literature quoted.

Abortion, Spontaneous↗

PubMed1998

Cervical spine disorders.

Recent research of disorders of the neck has concentrated on the efficacy of manual and other conservative therapies for neck pain and whiplash. Systematic reviews paint a poor picture of the quality of literature upon which many conventional, conservative therapies are based. Conclusive scientific data are lacking. Despite its unsavory reputation, whiplash has attracted considerable scientific inquiry. Multiple studies have brought data to bear that indicate that chronic neck pain after whiplash is not psychogenic, and that psychologic distress is secondary to the pain. Strong studies have shown that cervical zygapophysial joint pain is the most common basis for chronic neck pain after whiplash but that this condition cannot be diagnosed other than by using controlled diagnostic blocks. Surgical treatment of cervical zygapophysial joint pain has been proven to be effective in a double-blind controlled trial.

Humans↗

PubMedDate not supplied

The controversy about what constitutes safe and nurturant infant sleep environments.

In 1999, the U.S. Consumer Product Safety Commission stated that cribs provide the safest sleep environment for infants. Scientific data fails to support that statement and controversy continues in the scientific, medical, and parenting communities. Recent data demonstrate that cribs may represent the most unsafe sleep. This article seeks to inform health care professionals of the issues involved in the controversy and to offer guidelines for educating parents about safe and unsafe sleep practices.

Bedding and Linens↗

PubMed2000

[Results of large-scale clinical trials and medical practice].

The results of large scale clinical trials are part of the scientific data on which medical and, in particular therapeutic decisions, are base; very concordant data may even be used to define appropriate or inappropriate prescribing behaviour in the context of recommendations or references of good medical practice. Large scale clinical trials, however, have limitations inherent to their method; they give a mean result observed in an average population. The true question is to know if the therapeutic benefit proved in a therapeutic trial will be observed in a given individual in the future. If the aim of treatment is to make a symptom disappear or act on an objective intermediate criterion related to the prognosis, the benefits for the individual are easy to assess. When the aim is to prolong life or prevent a recurrence of a serious illness, the probability of avoiding a complication by treatment is only a statistic. This probability depends o: the amplitude of the therapeutic benefit observed in the trials; the resemblance of the patient to the "mean population" included in trials; the comparison of the treatment of the patient with the "mean treatment" used in the trials. An exact understanding of scientifically proven data then encounters the limits of the capacity of human memory. Probability medicine remains, however, the method which enables, for a given patient, the choice of treatment with the greatest chance of being effective, providing the elementary rules of utilisation of the information are respected.

Clinical Trials as Topic↗

PubMed2004

[Medicinal cannabis for diseases of the nervous system: no convincing evidence of effectiveness].

--In 1996, the Netherlands Health Council issued a negative recommendation regarding the use of medication on the basis of cannabis (marihuana). However, interest in medicinal cannabis has certainly not waned since. --The neurological diseases for which cannabis could presently be used therapeutically are: multiple sclerosis, chronic (neuropathic) pain and the syndrome of Gilles de la Tourette. --Since September 2003, the Dutch Ministry of Health, Welfare and Sport delivers medicinal cannabis to Dutch pharmacies, so that now for the first time, medicinal cannabis can be given to patients on a prescription basis within the framework of the Opium Law. The result of this is that doctors and patients now assume that this is a medication for which the efficacy and safety have been established. --The question arises whether new scientific data have become available since 1996 that provide scientific support for the current Governmental policy. --In a recent clinical trial that has aroused much discussion, patients with multiple sclerosis and problematic spasticity were treated with oral cannabis or a placebo. There was no significant effect of treatment on the primary outcome measure, i.e. objectively determined spasticity. Nevertheless, it was concluded that the mobility was improved and that the pain was subjectively decreased. --Until now, convincing scientific evidence that cannabinoids are effective in neurological conditions is still lacking. --However, it is also not possible to conclude definitely that cannabinoids are ineffective; still, this is no basis for official stimulation of their use.

Cannabis↗

PubMed2000

Use of a secure Internet Web site for collaborative medical research.

Researchers who collaborate on clinical research studies from diffuse locations need a convenient, inexpensive, secure way to record and manage data. The Internet, with its World Wide Web, provides a vast network that enables researchers with diverse types of computers and operating systems anywhere in the world to log data through a common interface. Development of a Web site for scientific data collection can be organized into 10 steps, including planning the scientific database, choosing a database management software system, setting up database tables for each collaborator's variables, developing the Web site's screen layout, choosing a middleware software system to tie the database software to the Web site interface, embedding data editing and calculation routines, setting up the database on the central server computer, obtaining a unique Internet address and name for the Web site, applying security measures to the site, and training staff who enter data. Ensuring the security of an Internet database requires limiting the number of people who have access to the server, setting up the server on a stand-alone computer, requiring user-name and password authentication for server and Web site access, installing a firewall computer to prevent break-ins and block bogus information from reaching the server, verifying the identity of the server and client computers with certification from a certificate authority, encrypting information sent between server and client computers to avoid eavesdropping, establishing audit trails to record all accesses into the Web site, and educating Web site users about security techniques. When these measures are carefully undertaken, in our experience, information for scientific studies can be collected and maintained on Internet databases more efficiently and securely than through conventional systems of paper records protected by filing cabinets and locked doors. JAMA. 2000;284:1843-1849.

Computer Security↗

PubMed1996

[Impact of rapid advancement of international standardization on technical requirements for new drug registration].

Internationalization of new drug research and development is rapidly progressing. When mutual international acceptance of clinical trial data is realized, scientifically superior data will eradicate and replace all not so scientific data. This means that healthy competition would benefit the data of clinical trials. The same is true of anti-tumor drugs. Some Japan originated antitumor drugs were developed in foreign countries prior to domestic clinical development. In future, geographic centralization of clinical trials in areas which can conduct scientifically more consistent trials is expected. There are only a limited number of institutes which can conduct high-quality clinical trials of antitumor drugs, so they want Japan, a potential country, to come to other areas to produce high-quality clinical trial data. The resolution of a number of daily stumbling blocks such as informing the patient that he or she is suffering from cancer is a prerequisite for conducting high-quality clinical trials. But every effort must be made so that it will not be said: "Data produced overseas are better. There is no need for Japan to use its knowledge and effort in the field of clinical development."

Antineoplastic Agents↗

PubMed2004

Techniques for optimization of queries on integrated biological resources.

Today, scientific data are inevitably digitized, stored in a wide variety of formats, and are accessible over the Internet. Scientific discovery increasingly involves accessing multiple heterogeneous data sources, integrating the results of complex queries, and applying further analysis and visualization applications in order to collect datasets of interest. Building a scientific integration platform to support these critical tasks requires accessing and manipulating data extracted from flat files or databases, documents retrieved from the Web, as well as data that are locally materialized in warehouses or generated by software. The lack of efficiency of existing approaches can significantly affect the process with lengthy delays while accessing critical resources or with the failure of the system to report any results. Some queries take so much time to be answered that their results are returned via email, making their integration with other results a tedious task. This paper presents several issues that need to be addressed to provide seamless and efficient integration of biomolecular data. Identified challenges include: capturing and representing various domain specific computational capabilities supported by a source including sequence or text search engines and traditional query processing; developing a methodology to acquire and represent semantic knowledge and metadata about source contents, overlap in source contents, and access costs; developing cost and semantics based decision support tools to select sources and capabilities, and to generate efficient query evaluation plans.

Algorithms↗

PubMed2003

Axiope tools for data management and data sharing.

Many areas of biological research generate large volumes of very diverse data. Managing this data can be a difficult and time-consuming process, particularly in an academic environment where there are very limited resources for IT support staff such as database administrators. The most economical and efficient solutions are those that enable scientists with minimal IT expertise to control and operate their own desktop systems. Axiope provides one such solution, Catalyzer, which acts as flexible cataloging system for creating structured records describing digital resources. The user is able specify both the content and structure of the information included in the catalog. Information and resources can be shared by a variety of means, including automatically generated sets of web pages. Federation and integration of this information, where needed, is handled by Axiope's Mercat server. Where there is a need for standardization or compatibility of the structures usedby different researchers this canbe achieved later by applying user-defined mappings in Mercat. In this way, large-scale data sharing can be achieved without imposing unnecessary constraints or interfering with the way in which individual scientists choose to record and catalog their work. We summarize the key technical issues involved in scientific data management and data sharing, describe the main features and functionality of Axiope Catalyzer and Axiope Mercat, and discuss future directions and requirements for an information infrastructure to support large-scale data sharing and scientific collaboration.

Animals↗

PubMed2005

Use of complementary and alternative medicine for the treatment of genital herpes.

Conventional antiviral drugs have proven effectiveness for genital herpes; however, patients continue to use a variety of complementary and alternative medicine (CAM) treatments. Given that patients may be using these products, it is important that healthcare providers become familiar with the data regarding safety and efficacy. We have reviewed available scientific data on six commonly used treatments (echinacea, eleuthero, L-lysine, zinc, bee products and aloe). In addition, information about a number of other products is presented in tabular form. Currently, there are insufficient clinical data to be confident of the efficacy and safety of any of these products for the treatment of genital herpes. It is hoped that future clinical trials will be conducted with sufficient rigour to provide guidance to the patients using these products.

Antiviral Agents↗

PubMedDate not supplied

Spatial domain wavelet design for feature preservation in computational data sets.

High-fidelity wavelet transforms can facilitate visualization and analysis of large scientific data sets. However, it is important that salient characteristics of the original features be preserved under the transformation. We present a set of filter design axioms in the spatial domain which ensure that certain feature characteristics are preserved from scale to scale and that the resulting filters correspond to wavelet transforms admitting in-place implementation. We demonstrate how the axioms can be used to design linear feature-preserving filters that are optimal in the sense that they are closest in L2 to the ideal low pass filter. We are particularly interested in linear wavelet transforms for large data sets generated by computational fluid dynamics simulations. Our effort is different from classical filter design approaches which focus solely on performance in the frequency domain. Results are included that demonstrate the feature-preservation characteristics of our filters.

Algorithms↗

PubMed1998

Complementary therapies for depression: an overview.

Depression is one of the most common reasons for using complementary and alternative therapies. The aim of this article is to provide an overview of the evidence available on the treatment of depression with complementary therapies. Systematic literature searches were performed using several databases, reference list searching, and inquiry to colleagues. Data extraction followed a predefined protocol. The amount of rigorous scientific data to support the efficacy of complementary therapies in the treatment of depression is extremely limited. The areas with the most evidence for beneficial effects are exercise, herbal therapy (Hypericum perforatum), and, to a lesser extent, acupuncture and relaxation therapies. There is a need for further research involving randomized controlled trials into the efficacy of complementary and alternative therapies in the treatment of depression.

Acupuncture Therapy↗

PubMed2006

What influences a health risk assessment?

In this paper it is claimed that the health risk assessment process is influenced by (at least) four general factors, namely: the regulatory framework, the quality and availability of scientific data, general risk assessment principles, and case-by-case assumptions. Furthermore, the scientific basis of risk assessment relies on three overall types of methods for data generation: standardized animal experiments, epidemiology, and non-standardized mechanism data. In this paper, the use of the different types of data for risk assessment purposes are analyzed in the light of the factors claimed to influence the risk assessment process. It is concluded that the availability of pre-defined criteria for the interpretation and evaluation of data for regulatory health risk assessment purposes need to be further developed. Especially with the implementation of the new European chemicals legislation REACH.

Animals↗

PubMed2005

Ritual use of plants with possible action on the central nervous system by the Kraho Indians, Brazil.

The aim of the present study was to document the use of plants, probably acting on the central nervous system (CNS), in rituals carried out by the Kraho Indians, who occupy the cerrado biome in the central region of Brazil. The 2 years of fieldwork were guided by methods of anthropology and botany. The local shamans have indicated 286 formulas, consisting of 138 plant species in 50 uses that could be associated with some type of action on the CNS; of which 98 formulas, 87 plants and 25 uses, appear to involve psychoactive properties, such as: 'to get slow', 'stimulant effect', 'to calm down', 'to enhance memory', 'to reduce anxiety' and 'to induce sleep'. Phytochemical and pharmacological literature data were queried to establish any correlation between indigenous knowledge and scientific indications, for each one of the 138 plant species. Studies were available for 11 of these plants; and for two of them, scientific data coincided with indigenous information.

Brazil↗

PubMed2002

Radio frequency chaff: the effects of its use in training on the environment.

Chaff is a radiofrequency countermeasure released by military aircraft, ships, and vehicles to confuse enemy radar. Chaff consists of aluminum-coated glass fibers ranging in lengths from 0.8 to 0.75 cm and is released in packets of 0.5 to 100 million fibers. The Department of Defense has determined that use of chaff in training is required for maintaining proficiency in the use of this countermeasure. At least 500 tons of chaff is released annually during training within selected military operating areas in the United States. Concerns have been raised about impact on the environment and its potential toxicity to humans, livestock, and wildlife. Many of these concerns have been addressed or are being researched by the Department of Defense and other agencies, but much of the data are unpublished. Herein, the authors summarize the issues and review scientific data for the impact of chaff use on humans, animals, and the environment.

Animals↗

PubMed2002

[Pneumocystis carinii pneumonia in patients without acquired immunodeficiency syndrome (AIDS)].

The incidence of Pneumocystis Carinii pneumonia (PCP) may rise due to a more extensive use of immunosuppressive therapy. Information and guidelines in the last decade regarding prevention, diagnosis and treatment of the disease were based upon data collected in patients with Acquired Immuno Deficiency Syndrome (AIDS). However, scientific data regarding risk factors, clinical manifestations and treatment of PCP in patients without AIDS is accumulating. The major risk factors for acquiring PCP are hematological malignancies and treatment with immunosuppressive drugs, especially corticosteroids. The clinical course deteriorates more rapidly than in patients with AIDS and many patients have other opportunistic coinfections, especially with Cytomegalovirus and Candida. The duration of treatment may be shorter and drug tolerance is usually better than in patients with AIDS. However, mortality remains high even with appropriate treatment and necessitates a high index of suspicion and the use of empiric treatment even before a definitive diagnosis is made.

Candidiasis↗