Financial conflicts of interest during meetings of the cardiovascular and renal drugs advisory committee.

CONTEXT: The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the Food and Drug Administration (FDA) reviews safety and efficacy data for cardiovascular and renal drugs, ultimately making recommendations to the Commissioner of Food and Drugs for approval. The Open Public Hearing segment of these meetings allows for patients, advocates, healthcare professionals, clinical trialists, and members of the public to provide testimony, which often results in expressing their preference for, or against, drug approval. Prior to providing testimony, the public speakers are highly encouraged to disclose any financial conflicts of interest (FCOIs) with the sponsor or other groups. Given the potential influence of these speakers on drug approval recommendations, we investigated the industry associations disclosed by public speakers in the Open Public Hearing section of the CRDAC meetings. Previous studies, such as one done by Lurie et al. indicated that positive testimony is tied to a higher likelihood of drug approval, and because drug companies provide financial compensation for speakers to provide testimony in general, we wanted to determine the likelihood with which speakers who have an FCOI provided a positive testimony vs. those without any FCOI. OBJECTIVES: The purpose is to evaluate whether public speakers with an FCOI are more likely to provide positive testimony regarding the drug in question during the CRDAC of the FDA between February 2009 and December 2019 through the use of publicly available transcripts. METHODS: Independent researchers investigated public transcripts and minutes of the CRDAC meetings with public speakers (n=20). We identified all speakers, along with characteristics such as an FCOI, and classified statements utilizing a pilot-tested Google form. The data collected were analyzed utilizing Stata. The speaker's testimony was then compared with their FCOI. An ordered logistic regression was performed utilizing the speaker's testimony regarding the drug as the dependent variable. RESULTS: Of the 88 speakers represented in our sample, 35 (35/88, 39.8%) disclosed an FCOI, most commonly regarding travel cost. Among speakers with an FCOI, 30 (30/35, 85.7%) spoke positively. Speakers with an FCOI were 4.96 times more likely to provide positive testimony (OR=4.96, 95% CI 1.67-14.78). Speakers with the disease were also more likely to provide positive testimony (OR=13.05, 95% CI 2.84-59.93). CONCLUSIONS: Public speakers often play a role during meetings, and they may also have an FCOI, most commonly related to travel expenses. Our study shows that speakers with an FCOI are more likely to provide positive testimony. Stipulations, such as requiring disclosure of FCOI and randomizing the selection process of speakers, can help ensure the integrity of the drug approval process.

Can Patients Travel by Air Less Than 1 Week After Lung Nodulectomy?

Objective: The study objective was to determine empirically based timing recommendations for safe air travel following lung nodulectomy. Methods: All patients who underwent pulmonary nonanatomic resection followed by air travel home immediately after discharge were identified at 2 institutions between 2014 and 2018. These patients were surveyed via telephone regarding any complications they may have experienced during their travel home and within the first week after discharge. These complications included shortness of breath, chest pain, drainage from their surgical sites, and evaluation by a health care provider in the interim, if they required. Results: Our study identified 27 patients who fit the inclusion criteria. The median number of days between surgery and flight home in the studied population was 4 days. The median number of days between chest tube removal and flight home was 2 days. None of the 27 patients reported experiencing shortness of breath, chest pain, drainage from their surgical sites, or need for evaluation by a health care provider within 1 week of discharge. Nine patients (33%) traveled by air with a small (<5%) pneumothorax documented on chest radiography after removal of thoracostomy tube. One (4%) patient successfully traveled without complication with a 10% pneumothorax. Conclusions: The findings of our study support the safety of air travel following lung nodulectomy in patients who have undergone uneventful wedge resection and have no significant pulmonary or cardiac comorbidities. It is not necessary for patients to wait the recommended 7 days prior to traveling.

Trial Registry Use in Surgery Systematic Reviews: A Cross-Sectional Study.

OBJECTIVE: To determine the extent to which systematic reviews published in surgery journals reported a clinical trial registry search as part of their search strategy and whether systematic reviews that omitted such searches would have located additional trials for inclusion. BACKGROUND: Systematic reviews are used by clinicians to guide clinical decision making. When conducting systematic reviews, the comprehensive search strategy is particularly critical to identify all studies-whether published or not-for producing an overall summary effect. Inclusion of only published studies may lead to overestimated and inaccurate summary effects; thus, it is important to consider unpublished studies. Here, we investigate the extent of clinical trial registry searches performed in surgical systematic reviews because trial registries may be the most viable approach to locate unpublished trial data. METHODS: We retrieved systematic reviews from the top surgery journals and the Cochrane Collaboration. Each was reviewed to determine which bibliographic databases were used and which, if any, trial registries were searched. RESULTS: Of 996 total systematic reviews, 252 (25.3%) reported having included a clinical trial registry search, with systematic reviews published in journals reporting searches of unpublished research at a rate of 6.4% (47/737). Reviews published by the Cochrane Collaboration included searches of unpublished research 79.2% of the time (205/259). CONCLUSIONS: Many systematic reviews published in surgery journals include only published research, which may contribute to publication bias. We recommend that authors maximize available information by using unpublished trial data found in clinical trial registries.