Policy masquerading as science: an examination of non-state actor involvement in European risk assessment policy for genetically modified animals

In 2013, at the request of the European Commission, the European Food Safety Authority (EFSA) announced a new risk assessment policy: Guidance on the environmental risks of genetically modified (GM) animals (‘Guidance’). This policy specifies the issues to be addressed in future risk assessments for GM animals. EFSA is the European Commission's scientific arm, responsible for food-related risk assessment. EFSA relies heavily on independent experts and consults non-state actors. Employing expert interviews and documentary analysis, the article explores non-state actor involvement in a traditionally expert domain through a case study. Analysis of EFSA's consultation demonstrates the inability of non-state actors to influence policy. The article argues that despite international legal obligations to develop risk assessment policy, the European Commission failed to recognize the Guidance as policy. When policy masquerades as science, unjustified restrictions are placed on non-state actor involvement and value judgements are cloaked from public scrutiny

Cultural sensitivity in screening adults for a history of childhood abuse: evidence from a community sample

BACKGROUND: A number of practice guidelines and recommendations call for the assessment of childhood abuse history among adult medical patients. The cultural sensitivity of screening questions, however, has not been examined. OBJECTIVE: To assess whether questions that inquire about childhood abuse history function differently for black and white patients. DESIGN: Cross-sectional telephone surveys in 1997 and 2003. SUBJECTS: Randomly sampled adults from Memphis, Tenn (1997, N = 832; 2003, N = 967). MEASUREMENTS: Physical, emotional, and sexual abuse scales of the Childhood Trauma Questionnaire–Short Form (CTQ-SF). Standardized mean difference technique for differential item functioning to assess for possible bias in CTQ-SF items. RESULTS: Controlling for total physical abuse scale scores, black respondents were significantly (P < .01) more likely than white respondents to report that they had been punished with a hard object during their childhood, but less likely to report having being hit so hard that it left marks, have been hit so hard that someone noticed, or to believe they had been physically abused. CONCLUSIONS: Inquiries that do not explicitly differentiate physical punishment from physical abuse may not be useful for black respondents because they tend to identify black respondents who report fewer clearly abusive experiences than comparable white respondents. Although untested in this study, one possible explanation is that physical discipline may be used more frequently and may play a different role among black families than among white families. These results underline the importance of attending to cultural factors in clinical history taking about childhood abuse histories

An evaluation of screening questions for childhood abuse in 2 community samples: implications for clinical practice

A number of practice guidelines and recommendations call for the assessment of childhood abuse in adult medical patients, but none specifies how best to do this. The objective of this study was to use evidence from 2 community-based population samples to evaluate abuse-screening questions that are often asked in medical clinics and to identify a small set of questions to improve screening practices. Methods: The Childhood Trauma Questionnaire Short Form (CTQ-SF) was administered in 2 randomized telephone interview surveys with adults aged 18 to 65 years. Results: A total of 880 (2003 survey) and 998 (1997 survey) respondents completed the CTQ-SF in the 2 surveys. In both surveys, the rates of physical (16% and 15%), emotional (31% and 29%), and sexual (10% and 9%) abuse elicited using 3 behaviorally descriptive items in each abuse category were approximately twice the rates elicited using the explicit labeling terms physically abused (8% and 8%), emotionally abused (15% and 13%), or sexually abused (5% and 5%) (P <.001 for each). Inquiries explicitly using the labeling term abuse successfully identified a low percentage of respondents who reported behaviorally described abusive experiences for each type of abuse (34%-51%). In addition, after adjustment for the number and frequency of abusive experiences in both surveys, women were more likely than men to label themselves as explicitly abused for any abuse (odds ratio [OR], 1.7; P=.11 and OR, 2.8; P <.01), physical abuse (OR, 2.1; P = .14 and OR, 2.9; P <.01), emotional abuse (OR, 2.7; P <.01 and OR, 3.3; P <.01), and sexual abuse (OR, 3.5; P=.08 and OR, 1.5; P=.55). Conclusion: Inquiries about childhood abuse that use broad labeling questions identify a substantially smaller number of patients than behaviorally specific questions and may be less effective in initial screening for a history of abuse

Maxillary Orthopedics In Class III Treatment

BACKGROUND: Ipilimumab is a fully human monoclonal antibody that binds cytotoxic T-lymphocyte antigen 4 to enhance antitumour immunity. Our aim was to assess the use of ipilimumab after radiotherapy in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel chemotherapy. METHODS: We did a multicentre, randomised, double-blind, phase 3 trial in which men with at least one bone metastasis from castration-resistant prostate cancer that had progressed after docetaxel treatment were randomly assigned in a 1:1 ratio to receive bone-directed radiotherapy (8 Gy in one fraction) followed by either ipilimumab 10 mg/kg or placebo every 3 weeks for up to four doses. Non-progressing patients could continue to receive ipilimumab at 10 mg/kg or placebo as maintenance therapy every 3 months until disease progression, unacceptable toxic effect, or death. Patients were randomly assigned to either treatment group via a minimisation algorithm, and stratified by Eastern Cooperative Oncology Group performance status, alkaline phosphatase concentration, haemoglobin concentration, and investigator site. Patients and investigators were masked to treatment allocation. The primary endpoint was overall survival, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00861614. FINDINGS: From May 26, 2009, to Feb 15, 2012, 799 patients were randomly assigned (399 to ipilimumab and 400 to placebo), all of whom were included in the intention-to-treat analysis. Median overall survival was 11.2 months (95% CI 9.5-12.7) with ipilimumab and 10.0 months (8.3-11.0) with placebo (hazard ratio [HR] 0.85, 0.72-1.00; p=0.053). However, the assessment of the proportional hazards assumption showed that it was violated (p=0.0031). A piecewise hazard model showed that the HR changed over time: the HR for 0-5 months was 1.46 (95% CI 1.10-1.95), for 5-12 months was 0.65 (0.50-0.85), and beyond 12 months was 0.60 (0.43-0.86). The most common grade 3-4 adverse events were immune-related, occurring in 101 (26%) patients in the ipilimumab group and 11 (3%) of patients in the placebo group. The most frequent grade 3-4 adverse events included diarrhoea (64 [16%] of 393 patients in the ipilimumab group vs seven [2%] of 396 in the placebo group), fatigue (40 [11%] vs 35 [9%]), anaemia (40 [10%] vs 43 [11%]), and colitis (18 [5%] vs 0). Four (1%) deaths occurred because of toxic effects of the study drug, all in the ipilimumab group. INTERPRETATION: Although there was no significant difference between the ipilimumab group and the placebo group in terms of overall survival in the primary analysis, there were signs of activity with the drug that warrant further investigation. FUNDING: Bristol-Myers Squibb