Conflicts between commercial and scientific interests in pharmaceutical advertising for medical journals.
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In 1992, researchers from the University of California, Los Angeles, published a study on the scientific merit and validity of pharmaceutical advertisements in medical journals. Their results led them to conclude, provocatively, that many pharmaceutical advertisements contained deficiencies in areas in which the U.S. Food and Drug Administration had established explicit standards of quality. This article provides a detailed account of third-party reactions to the study following its publication in the Annals of Internal Medicine, as well as the implications for those involved, including the authors, editors, and publisher. The increasingly diverging interests between medical journal editors and publishers are also discussed and highlighted by two recent cases of editors' departures from prominent general-interest medical journals. (+info)
Town-level characteristics and smoking policy adoption in Massachusetts: are local restaurant smoking regulations fostering disparities in health protection?
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OBJECTIVES: We identified and quantified differences in sociodemographic characteristics of communities relative to the strength of local restaurant smoking regulations in Massachusetts. METHODS: We examined the relationship between the strength of the 351 local restaurant smoking regulations in Massachusetts and a number of town-level characteristics, using a multinomial logistic regression model. RESULTS: Characteristics important to the adoption of stronger restaurant smoking regulations included higher education and per capita income, geographic region, voter support for a state cigarette tax initiative, board of health funding to promote clean indoor air policy making, and the presence of a bordering town with a strong regulation. CONCLUSIONS: The current pattern of smoke-free restaurant policy enactment fosters socioeconomic and geographic disparities in health protection, undermining an important national health goal. (+info)
Effect of local restaurant smoking regulations on environmental tobacco smoke exposure among youths.
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OBJECTIVES: We examined the effect of local restaurant smoking regulations on restaurant environmental tobacco smoke exposure among youths. METHODS: We interviewed 3863 Massachusetts youths aged 12-17 years and ascertained how often they saw smokers in restaurants in their town. We assessed the effect of local restaurant smoking regulation strength on nonexposure to environmental tobacco smoke (seeing smokers never or only rarely). RESULTS: Compared with youths from towns with weak regulations, youths from towns with medium-strength regulations had 1.4 times the odds (odds ratio = 1.36; 95% confidence interval = 1.12, 1.65) and youths from towns with strong regulations had twice the odds (odds ratio = 2.03; 95% confidence interval = 1.64, 2.52) of reporting nonexposure. CONCLUSIONS: Strong local restaurant smoking regulations are associated with reduced environmental tobacco smoke exposure among youths (+info)
State legislative efforts to regulate use and potential misuse of genetic information.
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The purpose of this study was to review existing and proposed legislation specifically intended to regulate the collection, use, and potential misuse of genetic data. The study encompasses laws relating to confidentiality, informed consent, discrimination, and related issues. It excludes from consideration legislation relating to medical records generally that may bear indirectly on genetic information. It also excludes both legislation relating to the regulation of DNA data collection for law enforcement purposes and state laws relating to the confidentiality of data collected by newborn-screening programs. While relatively few laws that explicitly regulate the treatment of genetic information have been enacted to date, a considerable amount of activity is currently underway in the nation's legislatures. Although most of the bills under consideration are not comprehensive in scope, they reflect a growing societal awareness that the uncontrolled dissemination and use of genetic data entails significant risks. (+info)
Regulatory pathways for vaccines for developing countries.
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Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. (+info)
Pressure mounts on policy restrictions.
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Following the Democratic primaries, the build-up to the US presidential election has begun and there is a growing call for changes to the science agenda. (+info)
Health Insurance Portability Accountability Act (HIPAA) regulations: effect on medical record research.
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OBJECTIVE: To evaluate the effect of impending HIPAA regulations on Applications for Exemptions from Institutional Review Board (IRB) approval. SUMMARY BACKGROUND DATA: HIPAA was implemented to reduce potential for misuse of personal information and restricts access to medical records by insurers, employers, and clinical researchers. We hypothesized that HIPAA regulations adversely impact medical records research. METHODS: The UW-Madison Human Subjects Committee database was accessed to evaluate success and delays in processing Applications for Exemption between September 1999 and March 2003. The number of protocols submitted, number of required revisions, and number considered nonexempt (requiring full IRB review) were determined. RESULTS: Prior to 2000, applications for medical records research were rare (11 applications in 1999-2000). In anticipation of the implementation of HIPAA regulations, a new application process was instituted in 2001. During that year, 92 of 103 were approved by an expedited process with few requiring full IRB approval. In 2002 to 2003, submissions increased to 199 and approval without revision dropped to 59% (P < 0.0001) as the number requiring revision (25%) and full IRB approval (16%) increased significantly (P < 0.0001 and P < 0.05, respectively). Of the 31 requiring full IRB approval, 7 were pursued while 24 (77%) were abandoned. CONCLUSION: HIPAA appears to inhibit medical record and database research. Ethical considerations in healthcare research are paramount, but current HIPAA implementation strategies increase workload for HSC and researchers, and increase the dropout rate for proposed studies when investigators are unable or unwilling to meet the regulatory requirements. It is unclear whether or to what degree the new requirements add to protection of privacy. Studies designed to investigate the costs and effects on quantity and/or quality of research should be prospectively implemented. (+info)
Europe plans gene testing framework.
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Genetic testing is set to enter mainstream healthcare and further population research but needs new regulation according to a European report, writes Nigel Williams. (+info)