The Impact Of Regulatory Stringency On The Foreign Direct Investment Of Global Pharmaceutical Firms

Cross-national regulatory differences in safety, price and intellectual property protection are an inherent feature of the operating environment of the global pharmaceutical firm. Institutional, transaction cost and more recent ‘race to the bottom’ theories assume that regulation represents a cost to the firm; therefore firms ‘vote with their feet’ and avoid investment in stringently regulated markets. However, a cross-national empirical study of the FDI levels of 20 firms across 19 markets reveals that regulatory stringency is not related to FDI, and price control stringency is positively related to FDI, when controlling for other market factors. National governments are not powerless in games of regulatory arbitrage, and have in fact developed adaptive strategies to maintain high regulatory standards and FDI simultaneously. Furthermore, global firms weigh various factors in their investment decisions, and suffer from classic optimisation problems, including information asymmetries and bounded rationality, which prevent total ‘regulatory optimisation’. The implications for existing theories of international business, globalisation and regulation are discussed.international business, foreign direct investment (FDI), globalisation, regulation, responses to regulation, political economy

Looking to the Future: Key Points for Sustainable Management of Northern Great Plains Grasslands

The grasslands of the northern Great Plains (NGP) region of North America are considered endangered ecosystems and priority conservation areas yet have great ecological and economic importance. Grasslands in the NGP are no longer self-regulating adaptive systems. The challenges to these grasslands are widespread and serious (e.g. climate change, invasive species, fragmentation, altered disturbance regimes, and anthropogenic chemical loads). Because the challenges facing the region are dynamic, complex, and persistent, a paradigm shift in how we approach restoration and management of the grasslands in the NGP is imperative. The goal of this article is to highlight four key points for land managers and restoration practitioners to consider when planning management or restoration actions. First, we discuss the appropriateness of using historical fidelity as a restoration or management target because of changing climate, widespread pervasiveness of invasive species, the high level of fragmentation, and altered disturbance regimes. Second, we highlight ecosystem resilience and long-term population persistence as alternative targets. Third, because the NGP is so heavily impacted with anthropogenic chemical loading, we discuss the risks of ecological traps and extinction debt. Finally, we highlight the importance of using adaptive management and having patience during restoration and management. Consideration of these four points will help management and restoration of grasslands move toward a more successful and sustainable future. Although we specifically focus on the NGP of North America, these same issues and considerations apply to grasslands and many other ecosystems globally

Fossa Navicularis Strictures Due to 22F Catheters Used in Robotic Radical Prostatectomy

Background and objectivesFossa navicularis strictures following radical prostatectomy are reported infrequently. We recently experienced a series of fossa strictures following robot-assisted laparoscopic radical prostatectomy. Fossa strictures are usually procedure-induced, arising from urethral trauma or infection; catheter size has not been reported as a factor. We describe herein our experience to determine and prevent fossa navicularis stricture development.MethodsFrom June 2002 until February 2005, 248 patients underwent robot-assisted laparoscopic prostatectomy with the da Vinci surgical system at our institution. Fossa strictures were diagnosed based on acute onset of obstructive voiding symptoms, IPSS and flow pattern changes, and bougie calibration. During our series, we switched from an 18F to a 22F catheter to avoid inadvertent stapling of the urethra when dividing the dorsal venous complex. All patients had an 18F catheter placed after the anastomosis for 1 week. Parameters were evaluated using Fisher's exact test and the Student t test for means.ResultsThe 18F catheter group (n=117) developed 1 fossa stricture, whereas the 22F catheter group (n=131) developed 9 fossa strictures (P=0.02). The fossa stricture rate in the 18F group was 0.9% versus 6.9% in the 22F group. The 2 groups had no differences in age, body mass index, cardiovascular disease, International Prostate Symptom Score, urinary bother score, SHIM score, preoperative PSA, operative time, estimated blood loss, cautery use, prostate size, or catheterization time.ConclusionsUsing a larger urethral catheter size during intraoperative dissection appears to increase the risk 8-fold for fossa stricture as compared with the 18F catheter. The pneumoperitoneum and prolonged extreme Trendelenberg position could potentially contribute to local urethral ischemia

Hypothermic Cooling Measured by Thermal Magnetic Resonance Imaging; Feasibility and Implications for Virtual Imaging in the Urogenital Pelvis.

OBJECTIVE: To study the combination of thermal magnetic resonance imaging (MRI) and novel hypothermic cooling, via an endorectal cooling balloon (ECB), to assess the effective dispersion and temperature drop in pelvic tissue to potentially reduce inflammatory cascade in surgical applications. METHODS: Three male subjects, before undergoing robot-assisted radical prostatectomy, were cooled via an ECB, rendered MRI compatible for patient safety before ECB hypothermia. MRI studies were performed using a 3T scanner and included T2-weighted anatomic scan for the pelvic structures, followed by a temperature mapping scan. The sequence was performed repeatedly during the cooling experiment, whereas the phase data were collected using an integrated MR-high-intensity focused ultrasound workstation in real time. Pelvic cooling was instituted with a cooling console located outside the MRI magnet room. RESULTS: The feasibility of pelvic cooling measured a temperature drop of the ECB of 20-25 degrees in real time was achieved after an initial time delay of 10-15 seconds for the ECB to cool. The thermal MRI anatomic images of the prostate and neurovascular bundle demonstrate cooling at this interface to be 10-15 degrees, and also that cooling extends into the prostate itself ~5 degrees, and disperses into the pelvic region as well. CONCLUSION: An MRI-compatible ECB coupled with thermal MRI is a feasible method to assess effective hypothermic diffusion and saturation to pelvic structures. By inference, hypothermia-induced rectal cooling could potentially reduce inflammation, scarring, and fistula in radical prostatectomy, as well as other urologic tissue procedures of high-intensity focused ultrasound, external beam radiation therapy, radioactive seed implants, transurethral microwave therapy, and transurethral resection of the prostate

Monocyte chemotactic protein-1 (MCP-1) as a predictor of prolonged urinary incontinence after radical prostatectomy

Objectives: To investigate monocyte chemotactic protein-1 (MCP-1) as a novel urinary biomarker to predict prolonged post prostatectomy incontinence. Methods: Men submitted urine samples prior to robotic radical prostatectomy. MCP-1 values were derived using an ELISA test. Pad usage at 7, 30, and 60 days were documented by patient post cards mailed when zero pads was reached. The primary outcome was defined as no incontinence pad usage at 30 days at prostatectomy. Results: After exclusions, 76 patients were included in analyses. Continence was reached by 29% (22/76), 56% (42/76), and (75/76) 98% at 7, 30, and 60 days, respectively. The average MCP-1 (p=0.258) was not different between the continent and incontinent groups. Highest quartile of MCP-1 (MCP > 166 pg/mL) and normalized MCP-1 (MCP-1/TV >0.53) noted a significant delay in continence at 30 days (p=0.050 and p=0.003). Only 26% (5/19) in the highest MCP1/TV quartile were continent, whereas 65% (37/57) of men in the 3 lower quartiles reached zero pad continence (p=0.003). In a logistic regression model the highest quartile of MCP1/TV had a significant chance of being incontinent at 30 days (OR 0.22; 95% CI 0.058-0.80; p=0.022). Conclusion: MCP-1/TV is a urinary biomarker that may predict prolonged urinary incontinence after radical prostatectomy