Halo and spillover effect illustrations for selected beneficial medical devices and drugs

Abstract

BackgroundNegative 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.MethodsData 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.ResultsWe 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.ConclusionsWe 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.

An evaluation of the FDA adverse event reporting system and the potential for reporting bias

“…Cognitive biases have been documented in various social scenarios, including the perception of side effects from placebo drugs (eg, the nocebo effect), the influence of a vegetarian label on calorie perception and food choices, and the perception of medical device category. [6][7][8] Similarly, increased media coverage has been shown to impact product impression. 9 Specifically, Faasse et al argued that increased symptom reporting was likely due to the news coverage increasing viewers' anxiety and increasing patients' expectations that they would also experience similar side effects.…”

“…These biases can be positive (“halo effect”) or negative (“horn effect”) and can result from a subjective experience rather than an objective, scientific process. Cognitive biases have been documented in various social scenarios, including the perception of side effects from placebo drugs (eg, the nocebo effect), the influence of a vegetarian label on calorie perception and food choices, and the perception of medical device category 6‐8 . Similarly, increased media coverage has been shown to impact product impression 9 .…”

Emerging health technology firms’ strategies and their impact on economic and healthcare system actors: a qualitative study

“…As heard many times during the interviews, a key strategy employed by entrepreneurs to educate large number of actors is to recruit support from other actors to enhance their reputation, via the prominence of key opinion leaders. This approach, also imported from pharmaceuticals, favors the firm visibility and positive image by providing access to key information such as case studies and practical applications to a set of actors who otherwise would have already formed an opinion of the product on incomplete information (Kerger et al 2016).…”