THE CODIFICATION OF INTERNATIONAL LAW

Any conclusion about the desirability or the practicability of codifying international law ought to be based on a clear idea of what the process would involve, and unfortunately codification is an ambiguous word. In the sense in which British and American lawyers use the word it relates to the form in which the law is presented. When we codify, we do not regard the task as one of improving the substance of the law, but as one of collecting the existing rules and stating them concisely and clearly. It is true that, even so, the work must involve some element of law-creating, for when we examine the materials on which we have to work, the customary rules, the judicial precedents, the particular statutes or conventions, we inevitably come across points on which no authority exists, or on which the existing authorities are conflicting, and it would be pedantic to insist that, because codification is concerned only with the form of the law, these defects should be reproduced in the finished code. Where the authorities are in conflict therefore, the codifier must choose the rule which seems the most desirable; where there are gaps in the existing law, he must suggest a new rule to fill them. To that extent codifiers must legislate. But it is only a limited extent. In the main, the work is not one of legislation, but of careful drafting. The few examples that we in England have of codification have been of this type. We have codified our law of sale of goods, and of bills of exchange in this way, and the result has been to tidy up the law on these topics. But that is its only important effect. It has not provided the layman with a sort of legal ready-reckoner, which many people seem to think a code ought to be able to do; and for the practising lawyer the chief difference is that instead of deducing the applicable rule from the decisions, he now uses the decisions to explain and illustrate the statutory rule

Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol

Background: Abiraterone acetate plus prednisolone (herein referred to as abiraterone) or enzalutamide added at the start of androgen deprivation therapy improves outcomes for patients with metastatic prostate cancer. Here, we aimed to evaluate long-term outcomes and test whether combining enzalutamide with abiraterone and androgen deprivation therapy improves survival. Methods: We analysed two open-label, randomised, controlled, phase 3 trials of the STAMPEDE platform protocol, with no overlapping controls, conducted at 117 sites in the UK and Switzerland. Eligible patients (no age restriction) had metastatic, histologically-confirmed prostate adenocarcinoma; a WHO performance status of 0–2; and adequate haematological, renal, and liver function. Patients were randomly assigned (1:1) using a computerised algorithm and a minimisation technique to either standard of care (androgen deprivation therapy; docetaxel 75 mg/m2 intravenously for six cycles with prednisolone 10 mg orally once per day allowed from Dec 17, 2015) or standard of care plus abiraterone acetate 1000 mg and prednisolone 5 mg (in the abiraterone trial) orally or abiraterone acetate and prednisolone plus enzalutamide 160 mg orally once a day (in the abiraterone and enzalutamide trial). Patients were stratified by centre, age, WHO performance status, type of androgen deprivation therapy, use of aspirin or non-steroidal anti-inflammatory drugs, pelvic nodal status, planned radiotherapy, and planned docetaxel use. The primary outcome was overall survival assessed in the intention-to-treat population. Safety was assessed in all patients who started treatment. A fixed-effects meta-analysis of individual patient data was used to compare differences in survival between the two trials. STAMPEDE is registered with ClinicalTrials.gov (NCT00268476) and ISRCTN (ISRCTN78818544). Findings: Between Nov 15, 2011, and Jan 17, 2014, 1003 patients were randomly assigned to standard of care (n=502) or standard of care plus abiraterone (n=501) in the abiraterone trial. Between July 29, 2014, and March 31, 2016, 916 patients were randomly assigned to standard of care (n=454) or standard of care plus abiraterone and enzalutamide (n=462) in the abiraterone and enzalutamide trial. Median follow-up was 96 months (IQR 86–107) in the abiraterone trial and 72 months (61–74) in the abiraterone and enzalutamide trial. In the abiraterone trial, median overall survival was 76·6 months (95% CI 67·8–86·9) in the abiraterone group versus 45·7 months (41·6–52·0) in the standard of care group (hazard ratio [HR] 0·62 [95% CI 0·53–0·73]; p<0·0001). In the abiraterone and enzalutamide trial, median overall survival was 73·1 months (61·9–81·3) in the abiraterone and enzalutamide group versus 51·8 months (45·3–59·0) in the standard of care group (HR 0·65 [0·55–0·77]; p<0·0001). We found no difference in the treatment effect between these two trials (interaction HR 1·05 [0·83–1·32]; pinteraction=0·71) or between-trial heterogeneity (I2 p=0·70). In the first 5 years of treatment, grade 3–5 toxic effects were higher when abiraterone was added to standard of care (271 [54%] of 498 vs 192 [38%] of 502 with standard of care) and the highest toxic effects were seen when abiraterone and enzalutamide were added to standard of care (302 [68%] of 445 vs 204 [45%] of 454 with standard of care). Cardiac causes were the most common cause of death due to adverse events (five [1%] with standard of care plus abiraterone and enzalutamide [two attributed to treatment] and one (<1%) with standard of care in the abiraterone trial). Interpretation: Enzalutamide and abiraterone should not be combined for patients with prostate cancer starting long-term androgen deprivation therapy. Clinically important improvements in survival from addition of abiraterone to androgen deprivation therapy are maintained for longer than 7 years. Funding: Cancer Research UK, UK Medical Research Council, Swiss Group for Clinical Cancer Research, Janssen, and Astellas

THE CODIFICATION OF INTERNATIONAL LAW

Any conclusion about the desirability or the practicability of codifying international law ought to be based on a clear idea of what the process would involve, and unfortunately codification is an ambiguous word. In the sense in which British and American lawyers use the word it relates to the form in which the law is presented. When we codify, we do not regard the task as one of improving the substance of the law, but as one of collecting the existing rules and stating them concisely and clearly. It is true that, even so, the work must involve some element of law-creating, for when we examine the materials on which we have to work, the customary rules, the judicial precedents, the particular statutes or conventions, we inevitably come across points on which no authority exists, or on which the existing authorities are conflicting, and it would be pedantic to insist that, because codification is concerned only with the form of the law, these defects should be reproduced in the finished code. Where the authorities are in conflict therefore, the codifier must choose the rule which seems the most desirable; where there are gaps in the existing law, he must suggest a new rule to fill them. To that extent codifiers must legislate. But it is only a limited extent. In the main, the work is not one of legislation, but of careful drafting. The few examples that we in England have of codification have been of this type. We have codified our law of sale of goods, and of bills of exchange in this way, and the result has been to tidy up the law on these topics. But that is its only important effect. It has not provided the layman with a sort of legal ready-reckoner, which many people seem to think a code ought to be able to do; and for the practising lawyer the chief difference is that instead of deducing the applicable rule from the decisions, he now uses the decisions to explain and illustrate the statutory rule