No abstract

Four lactating cows fitted with T-type cannulae in the proximal duodenum were utilized in a 4 X 4 Latin square design to study rumen microbial degradation of methionine hydroxy analog, a methionine supplement. A diet consisting of 55% concentrate and 45% corn silage was fed ad libitum four times daily. The four treatments were 1) control, no methionine hydroxy analog, 2) methionine hydroxy analog in the form of a calcium salt, 3) methionine hydroxy analog in the acid form, and 4) DL-methionine. The amino acids were incorporated into a grain mix, which was top-dressed. All diets were isonitrogenous. Twelve samples of duodenal digesta and fecal matter were collected during the last 3 d of each of the four 14-d periods. Samples were composited for analysis. Microbes either altered or degraded 99% of the methionine hydroxy analog in the rumen, since recovery of the analog in duodenal digesta was less than 1% of the amount fed for both the acid form and the calcium salt.

The policy change resulted in both price decreases and increases without substantive implications on affordability.

letters containing 655 violations for 204 drugs across multiple therapeutic areas were issued by the FDA all of which were clinical. Most often multiple violations for > 1 drug were contained in a single letter. On average, ~36 warning letters were issued per year. Omission of risk information was the most frequently violation claim (29.0%) followed by unsubstantiated/overstatement of efficacy claims (24.76%), and broadening of indication (11.6%). There were no misleading QoL, or economic claims issued. Warning letters were primarily directed to manufacturers of oncology (17.5%), psychiatry (9.6%), cardiovascular (9.6%), and pain (8.8%) products. Approximately half (49.5%) of claims contained promotional materials directed to physicians. CONCLUSIONS: We found that misleading clinical outcome claims, specifically omission of risk information and inaccurate efficacy, formed the majority of the promotional violations. Compared to the preceding 6 years (2003)(2004)(2005)(2006)(2007)(2008), substantially more FDA warning letters were issued (65 vs 178) possibly indicating greater surveillance by the FDA of pharmaceutical promotional materials