Third-party certification of dietary supplements: prevalence and concerns.

According to recent studies, over 50% of the general population (and nearly 70% of military personnel) report regular use of dietary supplements (DS). Military personnel may be at greater risk for adverse reactions to DS because of operational environments and stressors (extreme heat, altitude, or sleep deprivation) associated with military deployments and training. As a recent example, the Department of Defense placed a medical hold on all DS containing the ingredient 1,3-dimethylamylamine in response to several fatalities linked to the use of this product. This study investigated product certification for DS in military commissaries (grocery stores), exchanges (department stores), and civilian retail stores. Overall, only 12% of the available products were certified by an independent scientific agency. Consumers should be aware that most over-the-counter DS do not have independent certification of product integrity. Although "third-party certification" does not ensure DS safety or effectiveness, it is important that consumers and health care providers are made aware that such product screening takes place, to help patients make more informed decisions about the purchase and use of DS.

Case reports: Death of active duty soldiers following ingestion of dietary supplements containing 1,3-dimethylamylamine (DMAA).

Dietary supplements and their associated adverse events are not uncommon in the U.S. military, and selected dietary supplements have been associated with a number of nontraumatic deaths in service members. Specific ingredients and dietary supplement products in the civilian community are often associated with multiple adverse events and some have subsequently been removed from the marketplace; the most notable in the last decade is ephedra. We present case reports for two soldiers who were taking commercially available dietary supplements containing multiple ingredients to include the sympathomimetic, 1,3-dimethylamylamine (DMAA); both collapsed during physical exertion from cardiac arrest and ultimately died. A presentation of their clinical courses and a discussion of the history and pharmacology of dietary supplement ingredients, including DMAA, are provided. Our cases highlight concerns that DMAA in combination with other ingredients may be associated with significant consequences, reminiscent of previous adverse events from other sympathomimetic drugs previously removed from the market.

Geoseq: a tool for dissecting deep-sequencing datasets.

BACKGROUND: Datasets generated on deep-sequencing platforms have been deposited in various public repositories such as the Gene Expression Omnibus (GEO), Sequence Read Archive (SRA) hosted by the NCBI, or the DNA Data Bank of Japan (ddbj). Despite being rich data sources, they have not been used much due to the difficulty in locating and analyzing datasets of interest. RESULTS: Geoseq http://geoseq.mssm.edu provides a new method of analyzing short reads from deep sequencing experiments. Instead of mapping the reads to reference genomes or sequences, Geoseq maps a reference sequence against the sequencing data. It is web-based, and holds pre-computed data from public libraries. The analysis reduces the input sequence to tiles and measures the coverage of each tile in a sequence library through the use of suffix arrays. The user can upload custom target sequences or use gene/miRNA names for the search and get back results as plots and spreadsheet files. Geoseq organizes the public sequencing data using a controlled vocabulary, allowing identification of relevant libraries by organism, tissue and type of experiment. CONCLUSIONS: Analysis of small sets of sequences against deep-sequencing datasets, as well as identification of public datasets of interest, is simplified by Geoseq. We applied Geoseq to, a) identify differential isoform expression in mRNA-seq datasets, b) identify miRNAs (microRNAs) in libraries, and identify mature and star sequences in miRNAS and c) to identify potentially mis-annotated miRNAs. The ease of using Geoseq for these analyses suggests its utility and uniqueness as an analysis tool.

PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy.

OBJECTIVES: Men with elevated serum prostate-specific antigen (PSA) levels and negative prostate biopsy findings present a dilemma because of the lack of an accurate diagnostic test. We evaluated the potential utility of the investigational prostate cancer gene 3 (PCA3) urine assay to predict the repeat biopsy outcome. METHODS: Urine was collected after digital rectal examination (three strokes per lobe) from 233 men with serum PSA levels persistently 2.5 ng/mL or greater and at least one previous negative biopsy. The specimens were collected from April 2004 to January 2006. The PCA3 scores were determined using a highly sensitive quantitative assay with transcription-mediated amplification. The ability of the PCA3 score to predict the biopsy outcome was assessed and compared with the serum PSA levels. RESULTS: The RNA yield was adequate for analysis in the urine samples from 226 of 233 men (ie, the informative specimen rate was 97%). Repeat biopsy revealed prostate cancer in 60 (27%) of the of 226 remaining subjects. Receiver operating characteristic curve analysis yielded an area under the curve of 0.68 for the PCA3 score. In contrast, the area under the curve for serum PSA was 0.52. Using a PCA3 score cutoff of 35, the assay sensitivity was 58% and specificity 72%, with an odds ratio of 3.6. At PCA3 scores of less than 5, only 12% of men had prostate cancer on repeat biopsy; at PCA3 scores greater than 100, the risk of positive biopsy was 50%. CONCLUSIONS: In men undergoing repeat prostate biopsy to rule out cancer, the urinary PCA3 score was superior to serum PSA determination for predicting the biopsy outcome. The high specificity and informative rate suggest that the PCA3 assay could have an important role in prostate cancer diagnosis.