Estimating production costs and retail prices in different poultry housing systems: conventional, enriched cage, aviary, and barn in Japan.

For many producers, introduction of improved animal welfare systems is a turning point in their future production strategies as it increases production costs. The increase in egg retail prices is of growing concern not only for producers, but also for retailers and consumers. However, no report has calculated the estimated production costs or retail prices associated with introducing practices that support improved animal welfare in poultry farms in Japan. Therefore, this study aimed to estimate the production costs and table egg prices of 6 types of laying hen systems: conventional cage (CC): 8- and 12-tiers (CC8, CC12), enriched cage (EC): 8- and 12-tiers (EC8, EC12), aviary (AV), and barn systems (BR). Production costs include land purchases, construction costs of facilities, equipment and machinery, quantity of feed provided, farming materials invested, and wages. As a result, farm gate prices were estimated as CC8 = 12.19, CC12 = 12.19, EC8 = 14.52, EC12 = 14.52, AV = 21.14, and BR = 28.74 [yen/egg], and the production cost, including building the new farm, increased by EC8 = 19.1%, EC12 = 19.1%, AV = 73.4%, and BR = 135.7%, respectively, referring to the value of CC. The results show that the prices increase in systems between CC and BN. The retail price or table egg price was estimated to be CC8 = 24.68, CC12 = 24.68, EC8 = 28.07, EC12 = 28.07, AV = 37.27, and BR = 48.53 [yen/egg]. The retail price of BR is approximately twice that of CC. In addition, assuming that all of Japan's eggs were produced in the BR system, the soaring cost of eggs would likely affect the prices of factory eggs, such as liquid eggs and other products, thus affecting the prices of various food products. Understanding the significant management costs that affect the retail price of eggs would facilitate improved policies and practical approaches to support poultry farms and sustainable farming activities while addressing public concerns.

Clinical development and review times for new drugs in Japan: associated factors.

The length of clinical development and review procedures related to new drugs approved in Japan in 2000-2009 were analyzed. The length of time taken for clinical development varied depending on diversification of strategies, and the review times showed a decline during this period. Regression analyses suggested that clinical development times were significantly shorter for non-new molecular entities (non-NMEs), priority reviews, conditional approvals, and drugs utilizing foreign clinical data. The review times were shorter for new drug applications (NDAs) submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) and for priority reviews. The effects of pre-NDA consultations were mixed; the review time was shorter, but the clinical development period was prolonged.

Delays in new drug applications in Japan and industrial R&D strategies.

The gap between Japan and both the United States (US) and the European Union (EU) with regard to access to new drugs is becoming a major issue in Japan. We analyzed the time lags involved in new drug application (NDA) and biological license application submissions in Japan, the US, and the EU in order to identify the causes of delayed access. The time lag related to submission of applications ("submission lag") was longer for in-licensed products and for non-Japanese companies. Factors related to costs of clinical studies and potential volumes of sales were not associated with the submission lag. A bridging strategy (extrapolative use of foreign clinical data in the clinical data package based on International Conference on Harmonisation guideline E5) seemed to reduce submission lag, but the association between the two diminished when the cause-and-effect relationship was specifically investigated. These results suggest that multinational companies are likely to place more emphasis on the choice of development strategies that successfully lead to their goal rather than on direct costs and expected sales when deciding to introduce their pharmaceutical products in Japan. Our findings indicate that the clinical development guidances that helps pharmaceutical companies decide on investment and strategies are also the key to narrowing the gap in access to new drugs.

Alpha-fetoprotein-producing male breast cancer accompanied with hepatocellular carcinoma: assessment by lectin-affinity profile.

An autopsy case associated with both male breast cancer and hepatocellular carcinoma in which serum alpha-fetoprotein (AFP) was extremely elevated is described. The source of AFP production was investigated. In lectin-affinity chromatography of the patient's serum, concanavalin A (ConA) binding pattern was not consistent with that of hepatocellular carcinoma, and lens culinaris agglutinin A (LCA) affinity indicated a similar pattern to hepatocellular carcinoma. The immunohistochemistry staining for AFP revealed positive reactivity in breast cancer cells, but was negative in hepatocellular carcinoma cells. To the best of our knowledge, there have been no reports of breast cancer exhibiting immunohistochemically positive AFP in breast cancer cells. In the present case, ConA binding test was useful for identification of the source of AFP production. Furthermore, corresponding aggravation of breast cancer to the elevation of AFP suggested the possibility that AFP might enhance breast cancer growth.

American Academy of Pediatrics. Committee on Practice and Ambulatory Medicine and Committee on Medical Liability. Pediatric physician profiling.

Employers, insurers, and other purchasers of health care services collect data to profile the practice habits of pediatricians and other physicians. This policy statement delineates a series of recommendations that should be adopted by health care purchasers to guide the development and implementation of physician profiling systems.

Effect of naftopidil on urethral obstruction in benign prostatic hyperplasia: assessment by urodynamic studies.

Thirty-two patients with voiding dysfunction attributable to symptomatic benign prostatic hyperplasia were treated with naftopidil, an alpha 1-blocker, at doses of 25-75 mg/day for 4-6 weeks. The efficacy of the drug was assessed from the changes in urinary symptoms and urodynamic data. Total symptom scores were significantly reduced after treatment (P < 0.001). Average flow rate and maximum flow rate were significantly increased (P < 0.001 and P < 0.001, respectively), and residual urine volume, residual urine rate (ratio of residual urine volume/sum of voided volume and residual urine volume), and maximum urethral closure pressure were significantly (P < 0.05, P < 0.01, and P < 0.05, respectively) reduced, and at bladder capacity, the first desire to void was significantly (P < 0.05) increased. The pressure/flow study demonstrated no changes in intravesical pressure at maximum flow, but a significant (P < 0.05) reduction in minimum urethral resistance. A mild side effect (dizziness) was noted in one patient (3.3%), which soon disappeared after the dose was decreased. The efficacy was good or excellent in 21 of 30 patients (70.0%). The drug was evaluated to be promising in the treatment of bladder outlet obstruction due to benign prostatic hyperplasia.

[Pharmacological assessment of functional alterations in the brain of rats exposed prenatally to methylazoxymethanol].

Functional development of the brain of rats exposed to methylazoxymethanol (MAM) at a dose of 1, 5 or 20 mg/kg, i.p., on day 15 of fetal life was assessed using pharmacological responses to several CNS acting drugs. In the rats treated with 20 mg/kg of MAM, the following results were observed: A marked decrease in the rearing activity in an openfield, failure of the development of supersensitivity in cataleptic response to haloperidol administered weekly, an increase in the head down sniffing frequency after apomorphine administration, prolongation of pentobarbital-induced sleeping time, a decrease in the seizure threshold to picrotoxin and kainic acid, and a significant decrease in the growth rate. In addition, the rats administered 1 mg/kg of MAM, which have been reported to detect no biochemical changes in the brain, exhibited different responses to the drugs used: A marked decrease in the rearing activity, nearly normal threshold to picrotoxin and kainic acid, a pronounced hypothermia after chlorpromazine administration, and no significant change in the brain weights. The results suggest that rats exposed to MAM in varying doses would be useful for evaluating the developmental process of neurons and its unification.

Comparative assessment of ultrasonography and computed tomography in adrenal disorders.

Comparative diagnostic assessment by ultrasonography (US) and computed tomography (CT) was performed in each of 17 patients with adrenal disorders. US is better than CT for demonstrating the intratumorous characteristics, the relationship between the tumor and the surrounding organs, and the organ from which large tumors arise, such as pheochromocytoma. On the other hand, CT is better able to detect small adrenal tumors in primary aldosteronism, although US with a sector or linear scanner can also detect small tumors in some cases. Adrenal hyperplasia in both Cushing's disease and congenital adrenogenital syndrome was more easily demonstrated by CT than by US. Of the two US instruments, a sector scanner was more useful in the delineation of the enlarged right nontumorous adrenal by scanning from the right intercostal region, but both scanners were of no use in the delineation of the enlarged nontumorous left adrenal in patients with obesity.