Direct-to-Consumer Advertising of Medical Devices Under Scrutiny

Mitka, Mike

doi:10.1001/jama.2008.528

Cited by 14 publications

(7 citation statements)

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“…The literature on direct-toconsumers-advertisement (DTCA) of health products has raised concerns regarding patient welfare and autonomy, suggesting that it tends to create unrealistic expectations among patients (Mitka, 2008;Geransar and Einsiedel, 2008;Williams-Jones, 2006). While this observation is supported by our findings, our detailed analyses identified the virtual tools and messages by which companies enticed patients to play multiple roles, even though they are not direct purchasers of their technologies.…”

Section: Ethical Implications Of Online Building Relationshipssupporting

confidence: 60%

“…Several studies on direct-toconsumer online advertising and sale in such areas concluded that it can threaten information privacy, challenge equitable and safe access to healthcare, increase exposure to unreliable and biased information (Williams-Jones, 2006;Geransar and Einsiedel, 2008;Boden and Diamond, 2008;Berg and Fryer-Edwards, 2008), impact negatively the patient/physician relationship (Mitka, 2008;Racine et al, 2008), corrupt the physician/ industry relationship, and increase overall spending in medical care (Jost, 2010).…”

Section: The Web As a Space For Corporate Relationship Buildingmentioning

confidence: 99%

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Building Business Relationships Through the Web: How Medical Technology Companies Enroll Stakeholders in Innovation Development and Uptake

Hivon¹,

Lehoux²,

Longo³

et al. 2013

International Review of Social Research

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Websites are perceived as an additional communication space where public and private institutions and their stakeholders can interact and develop sustainable relationships. Although public relations scholars argue that both companies and consumers may benefit from virtual interactions, the growing online direct-to-consumer advertising and sale of health-related products has raised social and ethical concerns. Our study seeks to clarify the scope and nature of the virtual relationships that are specific to medical devices companies. Through a qualitative analysis of website, we show how four Canadian medical technology companies sought to enroll three types of stakeholders into their innovation development and commercialization strategies: investors, healthcare providers and patients. Our findings show that by reinforcing stereotypical relationships with investors, the websites maintain certain disconnect between the worlds of business and healthcare, and by creating proactive roles for healthcare providers and patients, they contribute to forge ethically convoluted relationships.

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Section: Ethical Implications Of Online Building Relationshipssupporting

confidence: 60%

Section: The Web As a Space For Corporate Relationship Buildingmentioning

confidence: 99%

Building Business Relationships Through the Web: How Medical Technology Companies Enroll Stakeholders in Innovation Development and Uptake

Hivon¹,

Lehoux²,

Longo³

et al. 2013

International Review of Social Research

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“…We hypothesize that the rapid adoption of robotic technology by multiple Wisconsin hospitals is caused at least in part by awareness that technology increases hospitals' appeal to patients. Manufacturers increasingly market devices directly to patients 22. Patients request pharmaceuticals from health care providers, and it is possible that they also have begun to respond to this marketing by directly requesting specific devices.…”

Section: Discussionmentioning

confidence: 99%

The Association of Robotic Surgical Technology and Hospital Prostatectomy volumes

Neuner

See

Pezzin

et al. 2011

Cancer

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“…In a prior investigation by The BMJ , the UK Medicines and Healthcare products Regulatory Agency was unable to provide any data on the numbers of high risk devices currently in use, 42 and similarly denied this information to researchers. 28 43 None the less, given the strong incentives for companies to market and sell their products as widely as possible, 44 we believe our studied devices represent those most likely to be used by patients and clinicians.…”

Section: Discussionmentioning

confidence: 99%

Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study

Hwang

Sokolov

Franklin

et al. 2016

BMJ

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Objective To evaluate safety alerts and recalls, publication of key trial outcomes, and subsequent US approval of high profile medical devices introduced in the European Union.Design Cohort study.Setting Novel cardiovascular, orthopedic, and neurologic devices approved in the EU through Conformité Européenne marking between 2005 and 2010.Data sources Public and commercial databases searched up to January 2016 for press releases and announcements of approvals; public Food and Drug Administration and European regulatory authority databases for US approvals and safety alerts and recalls; and Medline, Embase, and Web of Science for peer reviewed publications.Main outcome measures We categorized the novelty of the devices in the study sample as a “major innovation” or an “other change,” and extracted descriptive data about the devices and information on any safety alerts and withdrawals. Linear regression models examined factors associated with differential EU and US approvals. Cox proportional hazards regression models were used to evaluate factors associated with safety alerts and recalls and the publication of trial outcomes for devices categorized as major innovations. Models controlled for time, therapeutic category, regulatory pathway, size of sponsoring company, and indicator variables for devices approved first in the EU and devices approved only in the EU.Results 67% (206/309) of devices identified were approved in both the US and the EU, of which 63% (129/206) were approved first in the EU. The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices approved first in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval 1.4 to 6.2) for devices approved first in the EU. The results of pivotal trials were published for 49% (37/75) of devices categorized as major innovations, with an overall publication rate of 37% five years after approval.Conclusions Devices approved first in the EU are associated with an increased risk of post-marketing safety alerts and recalls. Poor trial publication rates mean that patients and clinicians need greater regulatory transparency to make informed decisions about treatment.

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Direct-to-Consumer Advertising of Medical Devices Under Scrutiny

Cited by 14 publications

References 0 publications

Building Business Relationships Through the Web: How Medical Technology Companies Enroll Stakeholders in Innovation Development and Uptake

Building Business Relationships Through the Web: How Medical Technology Companies Enroll Stakeholders in Innovation Development and Uptake

The Association of Robotic Surgical Technology and Hospital Prostatectomy volumes

Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study

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