The sunshine act and medical publications: Guidance from professional medical associations

Toroser, Dikran; DeTora, Lisa; Cairns, Angela; Juneja, Renu; Georgieva, Anna; Weigel, Al; Pepitone, Kim

doi:10.1080/00325481.2015.1084211

Cited by 9 publications

(19 citation statements)

References 21 publications

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“…Hence, most lack of clarity relates to medical writing support outside of this context. According to some recent publications, reporting such support as a TOV may potentially create a negative impression, such as the appearance of payment for authorship 7,15 .…”

Section: What's Clear?mentioning

confidence: 99%

“…Concerns have been raised over public misperception, which may potentially have unpredictable effects on physicians' behavior. Physicians may perhaps unnecessarily limit their interactions with manufacturers, perhaps limiting their participation in clinical research, which may be detrimental to research and innovation 7 . Additionally, some researchers may become more reluctant to be authors of industry sponsored research if TOVs attributed to them are perceived negatively by their home institutions 19 .…”

Section: Impact On the Research Processmentioning

confidence: 99%

“…A recent report concluded that professional guidance on how to interpret elements of the Sunshine Act is not extensive, and that the lack of information could potentially have a "chilling effect" on physicians' desire to participate in clinical trials and publish results 15 . Thus far, the guidance provided to physicians on the Act and the interpretation of non-monetary support from industry is at best sparse 7,24 . Some physician specialty groups have published information to help aid in understanding the context of the information contained in the Open Payments database.…”

Section: Impact On the Research Processmentioning

confidence: 99%

“…An important focus of the Sunshine Act is on research-related TOV 7,19 . Some recent reports have noted a coincident decrease in research spending with the implementation of the Act; however, it seems premature to suggest a causal association between the Act and changes in research funding 23 .…”

Section: Impact On the Research Processmentioning

confidence: 99%

“…due to corporate integrity agreements (CIAs) and state-level laws, the Sunshine Act is much broader in scope. In preparation, the largest medical association, the American Medical Association (AMA), advised its members to "be prepared for inquiries from the media, your patients and your friends" and provided a set of "talking points" for members 7 .…”

Section: Introductionmentioning

confidence: 99%

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Two years into the Sunshine Act: synopsis of opportunities, challenges, learnings, and potential implications

Toroser

Pepitone²

2016

Current Medical Research and Opinion

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Responsible transparency helps to promote integrity between industry and researchers and has the potential to increase public trust. As part of its inevitable evolution, the Open Payments database is likely to have opportunities to increase and improve the context around the data that it reports, thus leading to a decrease in the currently encountered confusion and misinterpretation of the data. A major challenge faced by the Centers for Medicare and Medicaid Services is to make the data more informative and educational, to allow the Sunshine Act to meet its transparency goals while improving healthcare innovation. ARTICLE HISTORY

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Section: What's Clear?mentioning

confidence: 99%

Section: Impact On the Research Processmentioning

confidence: 99%

Section: Impact On the Research Processmentioning

confidence: 99%

Section: Impact On the Research Processmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Two years into the Sunshine Act: synopsis of opportunities, challenges, learnings, and potential implications

Toroser

Pepitone²

2016

Current Medical Research and Opinion

Self Cite

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Association of Mandatory Disclosure Policies and Laws With Physician-Industry Financial Relationships

et al. 2019

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Beside the goal of increasing transparency to the public, disclosure policies and laws have been established with a goal to also reduce ethically questionable financial relationships between physicians and the medical industry. Data on these relationships should be reviewed to understand the association between these policies and laws and the attainment of reduced relationships. OBJECTIVE To assess whether disclosure policies and laws have been associated with a decrease in financial disclosure reporting by physicians. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional study uses yearly data from 2008 through 2015 from the participants in the American Academy of Ophthalmology's Annual Meeting. Trends in financial disclosures over time were investigated for the association of disclosure policies and laws with potentially beneficial, as well as ethically questionable physician-industry ties. Linear regression models were used to estimate the annual change in financial disclosures and are reported with 95% CIs. EXPOSURES Disclosure policies and laws. MAIN OUTCOMES AND MEASURES The annual aggregate financial disclosures by type (ie, consultant, lecturer, employee, grant support, equity owner, patent holder). RESULTS Financial disclosures increased from 3966 in 2008 to 5266 in 2015 (P < .001). The number of disclosures reported in the categories consultant, equity owner, patents, and grant support all increased from 2008 to 2015 (consultant disclosures, 121 [95% CI, 88-155] per year; P < .001; equity owner disclosures, 32 [95% CI, 22-42] per year; P < .001; patent disclosures, 19 [95% CI, 13-26] per year; P < .001; grant support disclosures, 78 [95% CI, 48-107] per year; P < .001), while the employee and lecturer categories did not change significantly. The percentage of financial disclosures in the lecturer category decreased relative to the total (estimate, −1.1% [95% CI, −1.3% to −0.8%] per year; P < .001), owing to the number of financial disclosures for this category remaining stable while most other types increased. CONCLUSIONS AND RELEVANCE Disclosure was not associated with a chilling effect (decrease in financial disclosures associated with potentially beneficial physician-industry ties). Disclosure was associated with a possible disinfecting effect, whereby the percentage of ethically questionable disclosures (ie, lecturers) decreased, although the frequency remained stable. A permissive effect (physicians becoming more inclined to having industry relationships) was also observed. Thus, disclosure rules should be enhanced or alternative approaches to disclosure reconsidered to promote a decrease in ethically questionable relationships.

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Ethical Concerns When Cancer Patients Become Human Research Participants and Are Treated on Clinical Trials

Theriault

2017

Ethical Challenges in Oncology

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The sunshine act and medical publications: Guidance from professional medical associations

Cited by 9 publications

References 21 publications

Two years into the Sunshine Act: synopsis of opportunities, challenges, learnings, and potential implications

Two years into the Sunshine Act: synopsis of opportunities, challenges, learnings, and potential implications

Association of Mandatory Disclosure Policies and Laws With Physician-Industry Financial Relationships

Ethical Concerns When Cancer Patients Become Human Research Participants and Are Treated on Clinical Trials

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