Potential Impact of PCB's on Bluefish, Pomatomus saltatrix, Management

Since 1979, anglers along the U.S. Atlantic coast have landed by weight more bluefish, Pomatomus saltatrix, than any other marine species. A fishery management plan has been developed jointly by three fishery management councils and the Atlantic States Marine Fisheries Commission to preserve the bluefish resource. Major objectives of the plan include prevention of recruitment overfishing and reduction in waste of bluefish. In 1985, a Federal survey found PCB concentrations in larger bluefish (over 500 mm fork length) that exceeded the U.S. Food and Drug Administration tolerance level of 2 parts per million. Harvest strategies are presented in this article to protect the reproductive capability of bluefish while minimizing human health risks associated with dietary intake of PCB's.

Trade secrets: a ten year overview of the illegal import of sea turtle products into the United States

For more than 25 years all sea turtle products have been prohibited from international commerce by the 170-member nations of the Convention on International Trade in Endangered Species (CITES). Sea turtles continue to be threatened by direct take (including poaching) and illegal trade despite multi-national protection efforts. Although take may contribute significantly to sea turtle decline, illegal take is difficult to measure since there are few quantified records associated with legal fisheries and fewer still for illegal take (poaching). We can, however, quantify one portion of the illegal sea turtle trade by determining how many illegal products were seized at United States ports of entry over a recent 10-year period. The United States Fish and Wildlife Service (USFWS) oversees the import and export of wildlife and wildlife products, ensuring that wildlife trade complies with United States laws and international treaties. Additionally, the USFWS has legal authority to target suspected illegal wildlife activity through undercover and field investigations. In an effort to assess the scale of illegal sea turtle take and trade, we have conducted a 10-year (1994 – 2003) review of the law enforcement database maintained by the USFWS. This database tracks the number and type of wildlife cases, the quantity of seized products, and the penalties assessed against violators. These data are minimum estimates of the sea turtle products passing through the United States borders, as smuggled wildlife is oftentimes not detected.

Fish sauce from two species of unexploited deep sea fish Peristedion adeni and Peristedion weberi

Two species of unexploited deep sea fish Peristedion adeni and Peristedion weberi caught from the Exclusive Economic Zone of India were subjected to fermentation at ambient temperature (30 ± 2°C) in the presence of salt in 4:1 ratio. Periodical analysis of the fermented product was carried out up to one year. The sauces had brownish yellow colour and conformed to special grade of the standards prescribed by the Food and Drug Administration. Further solubilization of protein after 9 month's maturation was not appreciable.

Entry and competition in generic biologics

Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologies can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical synthesis, biologies are manufactured through fermentation, a process that is more variable and costly. Regulators might require extensive clinical testing of generic biologies to demonstrate equivalence to the branded product. The focus of the debate on generic biologies has been on legal and health concerns, but there are important economic implications. We combine a theoretical model of generic biologies with regression estimates from generic pharmaceuticals to estimate market entry and prices in the generic biologic market. We find that generic biologies will have high fixed costs from clinical testing and from manufacturing, so there will be less entry than would be expected for generic pharmaceuticals. With fewer generic competitors, generic biologies will be relatively close in price to branded biologies. Policy makers should be prudent in estimating financial benefits of generic biologies for consumers and payers. We also examine possible government strategies to promote generic competition. Copyright © 2007 John Wiley & Sons, Ltd.

From Lydia Pinkham to Queen Levitra:Direct-to-consumer advertising and medicalisation

The medicalisation of life problems has been occurring for well over a century and has increased over the past 30 years, with the engines of medicalisation shifting to biotechnology, managed care, and consumers. This paper examines one strand of medicalisation during the last century: direct-to-consumer advertising (DTCA) of pharmaceuticals. In particular, it examines the roles that physicians and the Food and Drug Administration (FDA) have played in regulating DTCA in the US. Two advertising exemplars, the late 19 century Lydia E. Pinkham's Vegetable Compound (for 'women's complaints') and contemporary Levitra (for erectile dysfunction) are used to examine the parallels between the patent medicine era and the DTCA era. DTCA re-establishes the direct and independent relationship between drug companies and consumers that existed in the late 19 century, encouraging self-diagnosis and requests for specific drugs. The extravagant claims of Lydia Pinkham's day are constrained by laws, but modern-day advertising is more subtle and sophisticated. DTCA has facilitated the impact of the pharmaceutical industry and consumers in becoming more important forces in medicalisation. © 2008 The Authors.

Lead in rice: Analysis of baseline lead levels in market and field collected rice grains

In a large scale survey of rice grains from markets (13 countries) and fields (6 countries), a total of 1578 rice grain samples were analysed for lead. From the market collected samples, only 0.6% of the samples exceeded the Chinese and EU limit of 0.2 μg g− 1 lead in rice (when excluding samples collected from known contaminated/mine impacted regions). When evaluating the rice grain samples against the Food and Drug Administration's (FDA) provisional total tolerable intake (PTTI) values for children and pregnant women, it was found that only people consuming large quantities of rice were at risk of exceeding the PTTI from rice alone. Furthermore, 6 field experiments were conducted to evaluate the proportion of the variation in lead concentration in rice grains due to genetics. A total of 4 of the 6 field experiments had significant differences between genotypes, but when the genotypes common across all six field sites were assessed, only 4% of the variation was explained by genotype, with 9.5% and 11% of the variation explained by the environment and genotype by environment interaction respectively. Further work is needed to identify the sources of lead contamination in rice, with detailed information obtained on the locations and environments where the rice is sampled, so that specific risk assessments can be performed.

Angle-closure glaucoma: impact, etiology, diagnosis, and treatment.

PURPOSE OF REVIEW:

Recent studies underscore the importance of angle-closure glaucoma (ACG) as a cause of world blindness. A major contribution in assessing the true impact of this disease has been an article estimating the number of persons with occludable angles, angle closure, and blindness from ACG in China as 28.2 million, 9.1 million, and 1.7 million, respectively. Although these numbers are based on data from Singapore and Mongolia, which may be applied to China only with caution, they emphasize the blinding potential of ACG, which is three times as likely to be associated with blindness as open-angle glaucoma (OAG).

RECENT FINDINGS:

Recent reports in the Chinese literature on ACG prevalence suffer from definitional problems that would appear to lead to systematic overestimates of ACG prevalence and underestimates of OAG prevalence. Nonetheless, data from studies by Chinese investigators further emphasize the strong association between ACG and blindness, with fully 16% of subjects with ACG blind in one report-a far higher proportion than for OAG in China and elsewhere. The importance of topiramate as a cause of secondary angle closure has recently been understood, in part, because of a series of 19 such cases reported by investigators at the Food and Drug Administration.

SUMMARY:

Angle closure in this setting appears to be caused by uveal effusion and anterior rotation of the ciliary body with resultant closure of the angle. The condition is not always responsive to laser iridectomy, and elimination of the causative agent appears to be critical. Ultrasonic biomicroscopy is a potential new diagnostic modality for ACG, allowing the measurement of novel parameters, such as the angle opening distance (AOD) at 500 microm (AOD 500). The efficacy of such parameters in improving screening for ACG can only be established by prospective studies of potentially at-risk eyes. A number of novel treatments for AC and angle closure have recently been proposed, including cataract extraction, paracentesis, and argon laser iridoplasty. As with proposed new diagnostic modalities, the efficacy of these treatments remains to be demonstrated with prospective studies, ideally organized in a controlled, randomized fashion.

Prevalence of open-angle glaucoma among adults in the United States.

OBJECTIVE:

To estimate the prevalence and distribution of open-angle glaucoma (OAG) in the United States by age, race/ethnicity, and gender.

METHODS:

Summary prevalence estimates of OAG were prepared separately for black, Hispanic, and white subjects in 5-year age intervals starting at 40 years. The estimated rates were based on a meta-analysis of recent population-based studies in the United States, Australia, and Europe. These rates were applied to 2000 US census data and to projected US population figures for 2020 to estimate the number of the US population with OAG.

RESULTS:

The overall prevalence of OAG in the US population 40 years and older is estimated to be 1.86% (95% confidence interval, 1.75%-1.96%), with 1.57 million white and 398 000 black persons affected. After applying race-, age-, and gender-specific rates to the US population as determined in the 2000 US census, we estimated that OAG affects 2.22 million US citizens. Owing to the rapidly aging population, the number with OAG will increase by 50% to 3.36 million in 2020. Black subjects had almost 3 times the age-adjusted prevalence of glaucoma than white subjects.

CONCLUSIONS:

Open-angle glaucoma affects more than 2 million individuals in the United States. Owing to the rapid aging of the US population, this number will increase to more than 3 million by 2020.

Consolidation. An account of parties in the United States, from the convention of 1787, to the present period

This document is an account of a convention of South Carolina state representatives following the drafting of the Declaration of Independence. There were three parties involved in the convention and the account is based on the notes of Mr. Luther Martin who attended as well Mr. Justice Yates’ account. The first party wished to abolish all state governments and have one uniform monarchical government for the continent that would be restricted and limited. The second party did not wish to abolish state governments to give their own state some importance. The third party was advocating for a federal government in conjunction with state government. This document is an account of the convention.

Speech of Hon. James H. Hammond, of South Carolina, on the relation of states; delivered in the Senate of the United States, May 21, 1860

The speech is a response by Hon. James H. Hammond as to whether or not the territorial governments established by Congress have the power to define and declare what shall be and what shall not be property within the territorial boundaries. The speech goes on to discuss colonists who went to newly purchased territory and claimed land as their own. He argues whether or not these people have sovereignty of the land over the government.

Correcting Interdevice Bias of Horizontal White-to-White and Sulcus-to-Sulcus Measures Used for Implantable Collamer Lens Sizing.

PURPOSE: To assess the agreement and repeatability of horizontal white-to-white (WTW) and horizontal sulcus-to-sulcus (STS) diameter measurements and use these data in combination with available literature to correct for interdevice bias in preoperative implantable collamer lens (ICL) size selection. DESIGN: Interinstrument reliability and bias assessment study. METHODS: A total of 107 eyes from 56 patients assessed for ICL implantation at our institution were included in the study. This was a consecutive series of all patients with suitable available data. The agreement and bias between WTW (measured with the Pentacam and BioGraph devices) and STS (measured with the HiScan device) were estimated. RESULTS: The mean spherical equivalent was -8.93 ± 5.69 diopters. The BioGraph measures of WTW were wider than those taken with the Pentacam (bias = 0.26 mm, P < .01), and both horizontal WTW measures were wider than the horizontal STS measures (bias >0.91 mm, P < .01). The repeatability (Sr) of STS measured with the HiScan was 0.39 mm, which was significantly reduced (Sr = 0.15 mm) when the average of 2 measures was used. Agreement between the horizontal WTW measures and horizontal STS estimates when bias was accounted for was г = 0.54 with the Pentacam and г = 0.64 with the BioGraph. CONCLUSIONS: Large interdevice bias was observed for WTW and STS measures. STS measures demonstrated poor repeatability, but the average of repeated measures significantly improved repeatability. In order to conform to the US Food and Drug Administration's accepted guidelines for ICL sizing, clinicians should be aware of and account for the inconsistencies between devices.

Message from the President of the United States to both Houses of Congress at the commencement of the second session of the twelfth Congress

November 4, 1812. Read, and ordered to be printed. Includes Documents accompanying the Message of the President of the United States to the two Houses of Congress, at the opening of the second session of the twelfth Congress United States. 12th Congress, 2nd session, 1812-1813. House.; United States. 12th Congress, 2nd session, 1812-1813. Senate.; United States. Congress. House.; United States. Congress. Senate. Printed by A. and C. Way

Message from the President of the United States, in relation to the claim of Virginia, an account of interest paid by that State, on moneys borrowed for the payment of the militia thereof, for services rendered the United States

April 13, 1824. Printed by order of the Senate of the United States. At head of title: 18th congress, 1st session. [64]. Printed by Cales and Seaton

Message from the President of the United States, to both Houses of Congress, at the commencement of the third session of the thirteenth Congress

Document no. 1 in U.S. 13th Congress, 3d session, 1814-1815. House. September 20, 1814. Read and committed to a committee of the whole House on the State of the Union. Printed by Roger C. Weightman