International Clearinghouse for Birth Defects Monitoring Systems. Proceedings of the 24th annual meeting. Cape Town, South Africa, 19 November 1997. Abstracts.
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There is no evidence concerning human carcinogenic potential of most substances to which workers are exposed. A case-control type method has been developed to discover heretofore unsuspected occupational carcinogens. Incident cases of cancer of several sites are ascertained and the subjects are interviewed to obtain detailed job histories. The job histories are subsequently examined by chemists and engineers who infer for each job a list of potential chemical and physical exposures. These lists of exposures then become the basis of case-control type statistical analyses, wherein each site included and each exposure noted in any history are evaluated for possible association. Controls can be selected in the general population, among non-cancer hospital patients or, as we do, among other cancer patients. Preliminary findings from a pilot study in Montreal show that 1) an efficient case ascertainment system and an acceptable interview procedure can be set up, 2) job histories provided by respondents are quite valid, 3) chemists' translations of job histories into histories of chemical exposures seem to be meaningful and useful, and 4) at least one carcinogenic agent, cigarette smoking, is detectable whether a population control series or a cancer control series is used.
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PURPOSE: The analgesic Tramadol HCl (Ultram) was approved in 1994 as a non-scheduled drug under the CSA provided that a novel risk-management program would be developed by an Independent Steering Committee (ISC). The risk-management program began in 1995 with the launch of Ultram, and has been modified over the past decade to accommodate Ultracet (Ultram and acetaminophen) in 2001 and generic tramadol in 2002. This provided a unique opportunity to study the potential changes in abuse as the generic and combination products became available. METHODS: To proactively detect cases of abuse and diversion, the ISC developed a comprehensive questionnaire which was completed quarterly by an extensive network of drug abuse experts (n = 309) and police agencies (n = 100) who were asked to indicate how many diversion cases involving Ultram, Ultracet, and generic tramadol were identified during the preceding 3 months and what were the ten most commonly diverted drugs in their catchment area during that period. RESULTS AND CONCLUSIONS: The data generated demonstrate that the abuse of tramadol remained very low despite new branded and generic formulations. Contrary to the hypothesis that cheaper generic drugs would lead to higher rates of abuse, we found no increase in abuse with the introduction of generic tramadol. Ultracet abuse rates, unlike those found with other widely used hydrocodone and oxycodone combination products, have been even lower than that observed for tramadol. Since the FDA has now mandated that proactive risk-management plans be implemented for new drugs, the tramadol risk-management plan may be useful as a prototypic model which can be modified to accommodate other drugs with abuse potential.
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Field-trapping experiments with synthetic 2,7-nonadiyl dibutyrate, the female-produced sex pheromone of the orange wheat blossom midge, Sitodiplosis mosellana (Géhin), demonstrated that pheromone traps were highly attractive to males and caught very few non-target organisms. Different formulations of pheromone were tested to identify the optimum release rate and dispenser type for use in pheromone traps in the UK. Key findings were that racemic pheromone was as effective as enantiomerically pure (2S,7R)-2,7-nonadiyl dibutyrate, that release rates higher than 0.5 microg day(-1) were not necessary and that the optimal formulation was a 1 mg pheromone loading in a rubber septum. Pheromone traps gave a reliable indication of peak midge emergence, onset of flight and abundance of midges throughout the season. A strong correlation between maximum trap catch and crop infestation levels was obtained.
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Clinical trials only allow for a limited assessment of adverse drug reactions (ADRs) due to their restricted number of patients, their short duration, and their narrow inclusion criteria. To assess potential ADRs in the population actually treated after drug approval, different systems for signal generation such as spontaneous reporting systems have been established and are required by drug laws in many countries. As of today epidemiological methods for signal confirmation for rare adverse events or events with long induction periods use record linkage databases such as the United Health Care (Ingenix) in the USA or the practice databases such as the General Practice Research Database in Great Britain. However, this approach also has its limitations. This type of database will be presented in this paper. In addition, databases operated by German public health insurance will be described. The topic of linking different data sources in Germany to support pharmaco-vigilance activities will be addressed.
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