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Kerger BD, Bernal A, Paustenbach DJ, Huntley-Fenner G. Halo and spillover effect illustrations for selected beneficial medical devices and drugs. BMC Public Health 2016; 16:979. [PMID: 27630095 PMCID: PMC5024505 DOI: 10.1186/s12889-016-3595-7] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2015] [Accepted: 08/18/2016] [Indexed: 12/12/2022] Open
Abstract
BACKGROUND Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a 'negative halo effect,' a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a 'negative halo effect' may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1) intrauterine contraceptive devices (IUDs); 2) silicone gel-filled breast implants (SGBI); 3) metal-on-metal hip implants (MoM); and 4) the drug Tysabri. METHODS Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events. RESULTS We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product's safety reputation and prevalent use may take decades in the U.S., even while these products may exhibit widespread use and good safety records in other countries. CONCLUSIONS We conclude that the 'negative halo effect' associated with a stigma, rather than an objective risk-benefit assessment of medical products can increase negative health outcomes for patients due to reduced or inappropriate product usage.
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Affiliation(s)
| | - Autumn Bernal
- Cardno ChemRisk, 130 Vantis, Suite 170, Aliso Viejo, CA 92656 USA
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Aladro Y, Terrero R, Cerezo M, Ginestal R, Ayuso L, Meca-Lallana V, Millán J, Borrego L, Martinez-Ginés M, Rubio L, de Andrés C, Miralles A, Guijarro C, Rodríguez-García E, García-Dominguez JM, Muñoz-Fernández C, López de Silanes C, Gómez M, Thuissard I, Cerdán M, Palmí I, Díaz-Garzón LF, Meca-Lallana J. Anti-JC virus seroprevalence in a Spanish multiple sclerosis cohort: JC virus seroprevalence in Spain. J Neurol Sci 2016; 365:16-21. [PMID: 27206867 DOI: 10.1016/j.jns.2016.03.050] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2016] [Revised: 03/28/2016] [Accepted: 03/30/2016] [Indexed: 10/22/2022]
Abstract
OBJECTIVE To estimate the seroprevalence of anti-JCV antibodies, seroconverting rates and evolution of antibody levels in a multiple sclerosis (MS) Spanish cohort. METHODS Multicenter, retrospective cross-sectional and longitudinal study. The JCV seroprevalence was analyzed in 711 MS patients by using 1st (STRATIFY-1) and 2nd generation (STRATIFY-2) two-step ELISA over 2.65 (±0.97) years. Seroconversion rate was obtained over 2 samples from 314 patients, and index stability from 301 patients with 3 or more samples available. The effect of each ELISA generation, demographics, clinical characteristics and therapy on seroprevalence was assessed by logistic regression. RESULTS The overall anti-JCV seroprevalence was 55.3% (51.6-58.9), similar across regions (p=0.073). It increased with age (p<0.000) and when STRATIFY-2 was used (60.5%, p=0.001). Neither sex nor immunosuppressive therapy had any influence. Yearly seroconversion rate was 7% (considering only STRATIFY-2). Serological changes were observed in 24/301 patients, 5.7% initially seropositive reverted to seronegative and 7% initially seronegative changed to seropositive and again to seronegative, all these cases had initial index values around the assay's cut-off. CONCLUSIONS JCV seroprevalence in Spanish MS patients was similar to that reported in other European populations. Changes in serostatus are not infrequent and should be considered in clinical decisions.
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Affiliation(s)
- Yolanda Aladro
- Multiple Sclerosis Unit, Department of Neurology, Getafe University Hospital, European University of Madrid, Spain.
| | - Rodrigo Terrero
- Multiple Sclerosis Unit, Department of Neurology, Getafe University Hospital, European University of Madrid, Spain
| | - Marta Cerezo
- Multiple Sclerosis Unit, Department of Neurology, Getafe University Hospital, European University of Madrid, Spain
| | - Ricardo Ginestal
- Department of Neurology, Universitary Hospital "Fundación Jiménez Díaz", Madrid, Spain
| | - Lucía Ayuso
- Department of Neurology, Universitary Hospital "Príncipe de Asturias", Alcalá de Henares, Madrid, Spain
| | | | - Jorge Millán
- Department of Neurology, General Hospital "La Mancha Centro", Alcázar de San Juan, Ciudad Real, Spain
| | - Laura Borrego
- Department of Neurology, Universitary Hospital "Fundación de Alcorcón", Madrid, Spain
| | | | - Luisa Rubio
- Department of Neurology, Universitary Hospital "Príncipe de Asturias", Alcalá de Henares, Madrid, Spain
| | - Clara de Andrés
- Department of Neurology, University Hospital "Gregorio Marañón", Madrid, Spain
| | - Ambrosio Miralles
- Department of Neurology, University Hospital "Infanta Sofía", San Sebastián de los Reyes, Madrid, Spain
| | - Cristina Guijarro
- Department of Neurology, Hospital "Santa Bárbara", Puertollano, Ciudad Real, Spain
| | | | | | | | | | - Mayra Gómez
- Department of Neurology, Universitary Hospital "Infanta Leonor", Madrid, Spain
| | | | - María Cerdán
- Department of Neurology, MS Unit, Universitary Clinic Hospital "Virgen de la Arrixaca" (IMIB-Arrixaca), Murcia, Spain; Cátedra de Neuroinmunología Clínica y Esclerosis Múltiple, UCAM, Universidad Católica San Antonio de Murcia, Spain
| | - Itziar Palmí
- Department of Neurology, Universitary Hospital "La Princesa", Madrid, Spain
| | | | - Jose Meca-Lallana
- Department of Neurology, MS Unit, Universitary Clinic Hospital "Virgen de la Arrixaca" (IMIB-Arrixaca), Murcia, Spain; Cátedra de Neuroinmunología Clínica y Esclerosis Múltiple, UCAM, Universidad Católica San Antonio de Murcia, Spain
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Gajofatto A, Benedetti MD. Treatment strategies for multiple sclerosis: When to start, when to change, when to stop? World J Clin Cases 2015; 3:545-555. [PMID: 26244148 PMCID: PMC4517331 DOI: 10.12998/wjcc.v3.i7.545] [Citation(s) in RCA: 183] [Impact Index Per Article: 18.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/29/2014] [Revised: 03/02/2015] [Accepted: 05/06/2015] [Indexed: 02/05/2023] Open
Abstract
Multiple sclerosis (MS) is a chronic inflammatory condition of the central nervous system determined by a presumed autoimmune process mainly directed against myelin components but also involving axons and neurons. Acute demyelination shows as clinical relapses that may fully or partially resolve, while chronic demyelination and neuroaxonal injury lead to persistent and irreversible neurological symptoms, often progressing over time. Currently approved disease-modifying therapies are immunomodulatory or immunosuppressive drugs that significantly although variably reduce the frequency of attacks of the relapsing forms of the disease. However, they have limited efficacy in preventing the transition to the progressive phase of MS and are of no benefit after it has started. It is therefore likely that the potential advantage of a given treatment is condensed in a relatively limited window of opportunity for each patient, depending on individual characteristics and disease stage, most frequently but not necessarily in the early phase of the disease. In addition, a sizable proportion of patients with MS may have a very mild clinical course not requiring a disease-modifying therapy. Finally, individual response to existing therapies for MS varies significantly across subjects and the risk of serious adverse events remains an issue, particularly for the newest agents. The present review is aimed at critically describing current treatment strategies for MS with a particular focus on the decision of starting, switching and stopping commercially available immunomodulatory and immunosuppressive therapies.
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