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Results tagged ' Melky Cabrera '
Drew's 4 RBIs Leads Assault As Nova Tames Chisox
The past two seasons the offense for the New York Yankees struggled to score even three runs a game because injuries decimated the roster. The 2015 version is healthy and – as the Chicago White Sox found out on Sunday – they are firing on all cylinders.
Stephen Drew drove in four runs and Jacoby Ellsbury and Mark Teixeira each homered to back a strong six innings from right-hander Ivan Nova as New York captured the rubber game of weekend series at U.S. Cellular Field.
The Yankees put the game out of reach by scoring five runs in the fourth and three runs in fifth against right-hander Jeff Samardzija (8-6), who ended up leaving in the fifth inning in what was his shortest outing of the season.
The stage was set when Ellsbury led off the game with his fourth home run of the season to give the Nova (4-3) and the Yankees an early 1-0 lead.
The Yankees turned the game into a rout starting with what looked to be a routine popup in shallow center by Brian McCann that became a single that dropped between three White Sox fielders with one out in the fourth inning.
Carlos Beltran followed by drawing a walk and Chase Headley hit a lined single to right to load the bases. Didi Gregorius then looped a two-run, opposite-field single to left.
Drew singled to reload the bases and Ellsbury hit a sacrifice fly that scored Headley and Brett Gardner rolled a two-run single to center to extend the lead to 6-0.
Teixeira opened the fifth by launching his 29th home run of the season and his third in the weekend series.
Later in the inning, after two were out, Samardzjia finally succumbed to the 100-degree heat and a rising pitch count by hitting Headley with a pitch and walking Gregorius.
White Sox manager Robin Ventura replaced Samardzjia with right-hander Scott Carroll and Drew greeted him with a two-run double to left.
Samardzjia was charged with a season-high nine runs on eight hits and two walks with three strikeouts in 4 2/3 innings of work.
Nova, meanwhile, was able to hold the White Sox down despite coming off an outing in which he left after five innings with arm fatigue.
Nova kept the White Sox off the board until the sixth, when Adam Eaton drew a walk to lead off the inning and advanced to second on a groundout by Jose Abreu. He then scored on a two-out single by Melky Cabrera.
Nova yielded just the one run on five hits and two walks with seven strikeouts in six innings.
The Yankees scored three more runs off Carroll in the seventh on a two-run triple by Drew and an RBI groundout by Ellsbury.
In their past three victories, the Yankees have outscored their opponents by a combined score of 46-14.
The victory improves the Yankees' season record to 59-45 and they hold a six-game lead over both the Baltimore Orioles and the Toronto Blue Jays in the American League East. The White Sox dropped to 50-53.
- Drew is doing a great job of recreating the Phoenix rising from the ashes. He was 3-for-5 with a double, a triple, two runs scored and three RBIs on Sunday. Drew has lost playing time this season to Gregorio Petit, Jose Pirela, Rob Refsnyder and Brendan Ryan and seemed destined to be released by the team. But he lately has been hitting the ball well as a platoon second baseman. On July 22, Drew was hitting .179. Since that time, he is 11-for-31 (.355) with a homer and seven RBIs. That has raised his season average to .199.
- The bottom of the order did the most damage to the White Sox with Headley batting seventh, Gregorius eighth and Drew ninth. That trio combined for seven of the 11 hits, eight of the 12 runs scored and seven of the 12 RBIs. Pitchers are finding out lately that those supposed soft spots in the batting order are no longer there. Samardzija expended so much energy dodging Alex Rodriguez, Teixeira, McCann and Beltran that the bottom of the order ended being his downfall.
- Nova bounced back nicely after leaving his last start after just 75 pitches due to concerns about his arm after undergoing Tommy John surgery last season. Nova has now won his past three starts and he has a 2.65 ERA with 13 strikeouts in 17 innings in that span. With Michael Pineda on the disabled list, it is good to see Nova begin to start to get a good groove going heading down the stretch.
Normally reliable left-hander Chasen Shreve gave up a pair of solo home runs to Alexei Ramirez and Geovany Soto in the seventh inning but the Yankees were already leading 12-1. Other than that there was nothing to say about this victory. The offense is just devastating and it is carrying this team for the first time in three seasons.
The Yankees placed rookie right-hander Diego Moreno on the 15-day disabled list on Sunday due to discomfort in his right elbow. Moreno, 28, was impressive in throwing 5 1/3 innings of scoreless and hitless relief against the Texas Rangers last week to win in his Major-League debut. However, he was tagged for four runs in three innings in an 8-2 loss to the White Sox on Saturday. He reported the discomfort to the Yankees on Sunday and he is scheduled to visit Dr. Christopher Ahmad in New York on Monday. The Yankees recalled right-hander Branden Pinder from Triple-A Scranton/Wilkes-Barre to take Moreno's place on the roster.
The Yankees will try to keep their bats hot despite a day off on Monday before opening up a three-game home series with the Boston Red Flops on Tuesday.
Right-hander Masahiro Tanaka (7-4, 3.80 ERA) will open the series of the Yankees. Tanaka gave up four runs on nine hits and three walks with three strikeouts in a loss to the Rangers on Wednesday.
The last-place Red Flops will have left-hander Henry Owens make his Major-League debut against the Yankees. Owens, 23, is 3-8 with a 3.16 ERA in 21 starts at Triple-A Pawtucket this season. The only reason he is pitching is because the Red Flops are now 13 games out and in last place in the division. So much for the pundits who predicted they would win the division. Hah!
Game-time will be 7:05 p.m. EDT and the game will be broadcast nationally by the MLB Network and locally by the YES Network.
Kuroda, Tex Help Yankees End Skid Against Jays
There are some managers who will say that their team needs to learn how to win. After four straight losses, Yankees manager Joe Girardi must have given his team a master class in Winning 101 on Wednesday.
Hiroki Kiroda gave the Yankees a solid effort, pitching into the seventh inning, and Mark Teixeira homered and drove in three runs as New York salvaged the final game of a three-game set against Toronto in front of a paid crowd of 34,710 at Rogers Centre.
Kuroda (5-5) yielded three runs on eight hits and two walks with four strikeouts in 6 1/3 innings to win his first game since May 28 when he defeated the Cardinals in St. Louis.
Initially, it did not look good for Kuroda when Jose Reyes led off the bottom of the first by cranking Kuroda's first offering into the second deck in the right-field bleachers to give the Blue Jays an early 1-0 lead.
However, Huroda settled in and the Yankees were able to score four runs in the third inning off right-hander Drew Hutchison.
Kelly Johnson opened the frame by drawing a walk and Francisco Cervelli slammed a double into the gap in right-center to score Johnson and tie the game. It was only Cervelli's second RBI of the season.
Two batters later, Jacoby Ellsbury singled up the middle to score Cervelli and Teixeira then launched a 0-1 change-up into the right-field bleachers to give Kuroda and the Yankees a comfortable 4-1 lead. It was Teixeira's 14th home run of the season and his second in three games in Toronto.
"The whole dugout was excited about those four runs," Teixeira told reporters after the game. "It had been a while since we had a lead."
The Blue Jays, however, did draw closer in the bottom of the fifth.
Munenori Kawasaki drew a one-out walk and with two out Reyes stroked a ground-rule double. Then Melky Cabrera slapped an opposite-field single to left to score two runs to cut the Yankees' lead to a run.
Hutchison (5-6) left after six innings having given up four runs on seven hits and two walks while he fanned six batters.
The Yankees did add a run in the sixth after Blue Jays left-hander Rob Rasmussen walked Brett Gardner, hit Derek Jeter in the foot with a pitch and then issued another free pass to Ellsbury to load the bases.
Blue Jays manager John Gibbons summoned right-hander Sergio Santos to pitch to Teixeira and Teixeira was able to loft a sacrifice fly to deep center to score Gardner.
The Yankees' bullpen took it from there as Shawn Kelley, Matt Thornton, Adam Warren and David Robertson held the Blue Jays scoreless on just two hits with no walks and three strikeouts over the final 2 2/3 innings.
Robertson retired all five batters he faced, including striking out the first three batters he faced, to earn his 18th save in 20 opportunities this season.
The victory improved the Yankees' season record to 40-37 and they are now 2 1/2 games behind the first-place Blue Jays in third place in the American League East. The Blue Jays dropped to 44-36.
- After poor outings from Chase Whitley and David Phelps the past two games, Kuroda was able to keep the Blue Jays contained to allow the Yankee offense to get untracked. Kuroda, 39, has been somewhat of a disappointment after he pitched so well in 2012 and 2013. With his 4.23 ERA, Kuroda could stand to start putting together some good outings and pitch more consistently.
- Teixiera's three RBIs give him 39 on the season, which currently leads the team. The Yankees are nearly at the halfway point of the season and it is embarrassing that their team leader only has 39 RBIs. But with Teixiera slowed by a hamstring injury and a sore right wrist and Brian McCann, Alfonso Soriano and Carlos Beltran all underperforming the Yankees will take anything they can get from Teixeira.
- Ellsbury was 3-for-4 with a run scored and an RBI. Ellsbury has now put together a stretch of eight games in which he is 11-for-31 (.355). But he only has one extra-base hit (a double) and three RBIs in that span.
- Brian Roberts was the only Yankee starter who failed to reach base in the game. He was 0-for-4 with a strikeout. Roberts was 7-for-18 (.389) with a home run and two RBIs in his previous five games. Roberts, 36, had his season average fall to .240.
- Despite the victory the Yankees were just 1-for-10 with runners in scoring position and they left the bases loaded in both the fifth and seventh innings. It is getting to the point where pitchers might just as well just intentionally walk the first three Yankees each inning because the odds the Yankees will score any runs is virtually nil.
The Yankees will have a day off on Thursday before opening a three-game home series starting on Friday against the reeling Boston Red Sox.
Left-hander Vidal Nuno (1-4, 5.88 ERA) will begin the series for the Yankees. His one victory was on May 7 and he is 0-4 with a 6.12 since then. He gave up four runs on six hits and two walks in 6 1/3 innings against the Baltimore Orioles on Saturday.
The Red Sox will pitch right-hander Brandon Workman (1-0, 2.88 ERA). Workman surrendered two runs on five hits and two walks with seven strikeouts in six innings in a no decision against the Cleveland Indians on June 15.
Game-time will be 7:05 p.m. EDT and the game will be broadcast nationally by the MLB Network and locally by the YES Network.
Yankees Force Jays Back To Earth With Sweep
When the Yankees came off their recent West Coast road trip to face the first-place Blue Jays at home they were hoping that they could just gain some ground on them. After completing a three-game sweep of them on Thursday the Yankees have to feel extremely blessed.
David Phelps pitched seven very gutty innings and the offense, while it did not send a single ball into the seats, wore down their American League East rivals as New York won its 16th straight game against Toronto at Yankee Stadium in front of a paid crowd of 40,169.
Phelps (3-4) held the booming bats of the Blue Jays in check except for a two-out two-run home run he served up to Melky Cabrera in the third inning that tied the score at 2-2. Those two runs were all Phelps would give up while holding the Jays to six hits while he walked two and struck out seven.
Phelps even helped himself out with a do-or-die fielding play in the fifth inning. With two out and Colby Rasmus on third, Cabrera hit a rocket shot that ricocheted off Phelps and rolled behind the mound. Phelps scrambled back to the ball and fired quickly to Mark Teixeira at first to barely nip Cabrera.
Meanwhile, the Yankees hitters were putting right-hander Drew Hutchinson (5-4) through a draining pitch-count wringer.
They scored single runs off him in the first two innings on sacrifice flies by Jacoby Ellsbury in the first and Kelly Johnson in the second. They then broke the 2-2 tie in the third inning when Ellsbury led off with a single, stole second and advanced to third on a single by Teixeira.
One batter later, Carlos Beltran scored Ellsbury with the Yankees' third sacrifice fly of the evening. In the meantime, they had forced Hutchison to throw 76 pitches in the first three innings.
The Yankees added a run in the fifth when Ellsbury laced a one-out single and, again, stole second. Then Teixeira drew a walk that ended the night for Hutchison.
Left-hander Aaron Loup was able to retire Brian McCann on an infield liner but Beltran lofted a ground-rule double into the bleachers in left-center to score Ellsbury.
Hutchinson was charged with four runs on six hits and four walks while he struck out three in 4 1/3 innings.
The Yankees added single runs in the sixth and seventh innings to extend their lead to 6-2 on a night when two big contributors to their bullpen, Dellin Betances and closer David Robertson, were unavailable.
Brian Roberts and his base-running keyed the sixth inning when he led off the frame with a single and stole second and third base. But manager Joe Girardi deserves some credit for some strategy after Brett Gardner drew a one-out walk.
Girardi elected to send Gardner as Derek Jeter bounced a ball to Jose Reyes at shortstop. Instead of being able to turn a double play, Reyes was forced to retire Jeter at first as Roberts scored and Gardner was standing safely at second.
The Yankees were able to load the bases on right-hander Steve Delabar in the seventh inning when Roberts drew a walk with two outs. Delabar then walked Yangervis Solarte to force in a run.
The Blue Jays did manage to make things interesting in the eighth inning when Jose Bautista drew a one-out walk from right-hander Shawn Kelley and Edwin Encarnacion followed by planting his 21st home run of the season into the left-field bleachers.
However, Kelley retired Dioner Navarro and Matt Thornton got the final out in the eighth and the first out in the ninth before he was touched for a single off the bat of Rasmus.
Adam Warren then came in to get pinch-hitter Munenori Kawasaki and Reyes to complete the sweep and earn his second save of the season.
With the victory, the Yankees are 38-33 and they are 1 1/2 games out of first place in the A.L. East. The struggling Blue Jays fell to 41-33.
- Phelps lost four consecutive starts from May 22 through June 7 and he was 1-4 with a 4.88 ERA at that point. But in his past two starts he has defeated the team with the best record in the American League (Oakland) and the best team in the A.L. East (Toronto). In those two starts he has given up two runs on eight hits and two walks and struck out 11 in 13 2/3 innings. He is 2-0 with a 1.32 ERA in those starts, which has lowered his season ERA to 4.11.
- The Yankees very much need Beltran's bat and they got it on Thursday. Beltran was 1-for-3 with a run scored and two RBIs. It was his first multiple RBI game since he drove in two runs against the Boston Red Sox on April 22 at Fenway Park. Beltran entered the contest 7-for-40 (.175) with a home run and three RBIs since he came off the disabled list on June 5.
- Ellsbury had another good night in going 2-for-4 with two stolen bases, two runs scored and an RBI. Ellsbury is now hitting .279 with four homers and 31 RBIs. But he also has stolen a team-best 20 bases and has an on-base percentage of .346. Add his skilled fielding in center and you have a very good player and a very smart free-agent signing by the Yankees.
Why complain when starters Masahiro Tanaka, Chase Whitley and Phelps combined to give up just five runs in 19 innings (a 2.37 ERA) in the three games against the hard-hitting Blue Jays. Whitley and Phelps may be considered as blowout patches for a starting rotation that lost Ivan Nova, CC Sabathia and Michael Pineda. But they are more than holding their own for Yankees at a time when they are very much needed. No complaints about this game.
The game was delayed for some time in the fourth inning when a rare base-runner interference play was called on Encarnacion after he led off with a single. Navarro followed with a routine pop fly to Teixeira just inside the first-base bag. Encarnacion used both of his hands to slide around Teixiera to return to first base while the ball was in the air and he was immediately called for interference by first-base umpire Chris Conroy. After initially calling Navarro out on the pop fly, the umpires conferred and placed Navarro at first base on a fielder's choice. . . . Johnson had to leave the game in the sixth inning when the fingers on his left hand were struck with the ball as he was attempting a bunt. Johnson was removed from the game and replaced by Solarte with a 3-2 count. Solarte struck out but the Yankees later scored Roberts on Jeter's groundout. Johnson underwent X-rays that did not indicate any broken bones. But Johnson is listed as day-to-day.
The Yankees now hope to continue their momentum against their A.L. East rivals when they begin a weekend three-game home series against the Baltimore Orioles.
Right-hander Hiroki Kuroda (4-5, 3.42 ERA) will open the series for the Yankees. Kuroda lost his start on Saturday, giving up four runs on five hits and three walks against the Oakland Athletics. Kuroda is 1-0 against the Orioles this season after beating them 4-2 on April 7 at Yankee Stadium in his second start of the season.
Right-hander Ubaldo Jimenez (2-8, 4.86 ERA) will start for the O's. The disappointing free agent gave up two runs on three hits and five walks in six innings in a loss to the Blue Jays last Friday. He has not won a game since May 8 and he was the losing pitcher to Kuroda in that game on April 7.
Game-time will be 7:05 p.m. EDT and the game will be broadcast nationally by the MLB Network and locally by MY9.
McCann-ical: Yankee Catcher's 5 RBIs Dumps Jays
For most of the season, the Yankees have been wondering where their All-Star slugging catcher Brian McCann was because the one they have been watching was hitting ,220 with seven homers and 28 RBIs. Well, cross your fingers and do a sign of the cross, but there was a rare McCann sighting at Yankee Stadium on Wednesday night.
McCann lined a two-run home run to put the Yankees ahead and later added a three-run triple as part of a career-best-tying five RBIs to lead New York past Toronto to bring them to within 2 1/2 games of the first-place Blue Jays in the American League East.
A paid crowd of 41,342 in the Bronx, N.Y., watched the Yankees win their 15th consecutive game over the Blue Jays at home.
Chase Whitley (3-0), buoyed by an early 1-0 lead, held the Blue Jays scoreless until the fourth inning when he was stung by back-to-back two-out RBI singles by Dioner Navarro and Colby Rasmus, who was just activated from the 15-day disabled list prior to the game.
But the Yankees were able to answer in the bottom of the fourth against left-hander Mark Buehrle (10-4), who has now lost his past three starts.
Carlos Beltran led of the frame with a single and McCann, after battling Buehrle to a 2-2 count in a nine-pitch at-bat, lined a curveball into the second row of the bleachers in right-field to give the Yankees a lead they would not relinquish the rest of the evening.
The home run was McCann's eighth of the season but his first since May 23 at U.S. Cellular Field in Chicago.
Buehrle was also touched for an unearned run in the first inning when Brett Gardner led off with a single, one of his four singles on the night. Derek Jeter then reached when Blue Jays third baseman Brett Lawrie misplayed Jeter's slow roller into an error.
Two batters later, another one of the Yankees struggling sluggers, Alfonso Soriano, slapped Buehrle's first pitch up the middle to score Gardner.
Buehrle was charged with three runs (two earned) on six hits and two walks with four strikeouts in six innings.
Whitley, however, was able to hold on for his third straight victory and the Yankees are now 7-0 in his starts since he was called up from Triple-A Scranton/Wilkes-Barre on May 15. He yielded two runs on five hits and one walk with two strikeouts in five innings.
The Yankees were able to put the game away in the seventh inning against right-hander Chad Jenkins and left-hander Brett Cecil.
Gardner singled and, two outs later, Jacoby Ellsbury and Mark Teixeira hit consecutive singles to load the bases. Blue Jays manager John Gibbons replaced Jenkins with Cecil and pinch-hitter Ichiro Suzuki drew a walk for score Gardner.
McCann then followed with a base-clearing triple into the gap in right-center to become the first Yankees catcher to hit a home run, a triple and drive in five runs in a game since Elston Howard did it in 1962.
The Blue Jays scored a run in the eighth off rookie right-hander Jose Ramirez on a leadoff double by Melky Cabrera and an RBI double off the bat of Jose Bautista. But the bullpen combination of Adam Warren, Dellin Betances and David Robertson pitched four scoreless innings on no hits, one walk and six strikeouts to close out the victory for Whitley.
The Yankees' season record is now 37-33 and they only trail the Jays by one game in the loss column in the tightly bunched A.L. East. The Blue Jays fell to 41-32.
- McCann was 2-for-3 with a walk and his five RBIs on Tuesday leave him in a tie with Teixeira for the team lead with 33. McCann, 30, a career .274 hitter, is still hitting only .226 but the Yankees are hoping that he is about to break out of what has been a prolonged power and hitting drought to provide what he did for the Atlanta Braves in his previous eight seasons.
- Gardner entered the game hitting .325 at Yankee Stadium this season and he added to it with a 4-for-5 night with four singles and two runs scored. In 30 games at home, Gardner is now 41-for-119 (.345) with four home runs and 15 RBIs. In his past nine games, Gardner is 14-for-38 (.386) with two homers and five RBIs.
- Whitley, who turned 25 on Saturday, got caught up in a heavy pitch count in trying to battle the major league's best home run hitting team. But he kept the Yankees in the game until the Yankees were able to take the lead in the fourth. Whitley's walk to Cabrera with one out in the fifth was the first he has issued since May 21 against the Chicago Cubs at Wrigley Field. In 38 2/3 innings, Whitley has walked just four batters. It looks like he is going to be a keeper in the rotation.
There are hints that the Yankees may be ready to bust out of their offensive funk and it could not have come at a better time because the Yankees are in the midst of 15 games against teams in their division. They have now won the first two of those 15 games against the best team in the division. They need to keep it going.
Left-hander CC Sabathia threw a bullpen session at Yankee Stadium on Wednesday for a second consecutive day and he is expected to throw another bullpen session on Saturday. Sabathia, who was limited to throwing just fastballs on Tuesday, mixed in some sliders on Wednesday and reported no problems with his right knee after the session. Sabathia has been sidelined since May 10 after having a stem-cell injection in his right knee. . . . Manager Joe Girardi told reporters on Wednesday that he is not considering any shakeup in the starting rotation but he is watching left-hander Vidal Nuno closely. Nuno is 1-3 with a 5.90 ERA this season and he was shelled for eight runs on eight hits in three-plus innings against the Oakland Athletics on Sunday. With right-hander Shawn Kelley back in the bullpen after a stint on the DL, Warren could be inserted into the rotation if Girardi needs to make a move.
The Yankees have a chance to sweep the first-place Blue Jays on Thursday and draw to within 1 1/2 games of the lead in the division.
Right-hander David Phelps (2-4, 4.32 ERA) gets the start for the Yankees. Phelps, 27, is coming off what may have been the best start of his career on Saturday when he shut out the A's on two hits and three walks while fanning four in 6 2/3 innings. That victory broke a string of four straight losses for Phelps.
Right-hander Drew Hutchison (5-4, 3.62 ERA) will pitch for the Blue Jays. Hutchison, 23, shut out the Baltimore Orioles on six hits with no walks and three strikeouts in seven innings for his fifth victory on Friday. He was lit up for six runs on six hits and three walks in 3 1/3 innings by the Yankees in Toronto on April 6.
Game-time will be 7:05 p.m. EDT and the game will be broadcast by the YES Network.
Tanaka Earns 11th Win As Yankees Top Blue Jays
Whispers around the American League caution teams that to beat Masahiro Tanaka you better get to him early in the count and in the game. The Toronto Blue Jays applied that game plan in Tanaka's first major-league start and again on Tuesday and it did not work either time.
In Tanaka's major-league debut, Melky Cabrera led off the game with a home run and the Blue Jays lost the game 7-3. Jose Reyes led off Tuesday's game by hitting Tanaka's first delivery into the right-field bleachers and Toronto still lost the game.
Tanaka (11-1) pitched six innings to record his major-league-leading 11th victory as New York cut a game off the Blue Jays' lead in the American League East with a victory over Toronto in front of a paid crowd of 41,834 at Yankee Stadium.
The 25-year-old right-hander yielded just that one run on five hits and two walks and he fanned 10 to lower his A.L.-leading ERA to 1.99 and post his 14th quality start in as many games pitched.
"What he's done has been remarkable," Yankees manager Joe Girardi told reporters.
The victory also was Girardi's 600th in his career as the team's manager, the sixth skipper to reach that mark.
Tanaka and the Yankees weathered the early 1-0 deficit before taking the lead in the bottom of the third against rookie right-hander Marcus Stroman, who is a native of nearby Medford, N.Y.
Kelly Johnson laced a one-out double to the wall in right-center and Brett Gardner followed by lining a 2-1 slider off the netting of the right-field foul pole for his sixth home run of the season.
Stroman (3-2) was charged with two runs on four hits and three walks while he struck out two in 3 2/3 innings.
The Yankees pushed across another run against left-hander Aaron Loup when Derek Jeter reached on an infield single and advanced to second on a wild pitch. After Jacoby Ellsbury's groundout advanced Jeter to third, Loup made a mistake by failing to walk Mark Teixeira on a 3-1 pitch.
Instead, the switch-hitting Teixeira lined Loup's inside fastball up the middle for a one-out RBI single with the left-hand-hitting Brian McCann on deck.
Meanwhile, Tanaka got even tougher, striking out Cabrera, Jose Bautista and Edwin Encarnacion on swinging strikes in succession in the fifth inning.
Rookie Dellin Betances pitched a perfect two innings, striking out three, and David Robertson pitched around a two-out triple by Munenori Kawasaki to notch his 17th save in 19 chances this season.
The victory improves the Yankees' season record to 36-33 and boosts them into second place in the A.L. East 3 1/2 games behind the first-place Blue Jays. The Jays are now 41-31.
- The conventional wisdom prior to the game was that because Tanaka's loss came against the only team he has faced twice this season, the Chicago Cubs, that the Blue Jays would have success against him in their second meeting. It did not happen. Tanaka was even better. "They mowed us down pretty good tonight," Blue Jays manager John Gibbons told reporters.
- If you combined the numbers this season for Tanaka, Betances and Robertson they are 15-3 with a 2.09 ERA with 224 strikeouts in 164 innings. I doubt seriously you can name a better starter and two-man bullpen combination in baseball today. They just dominate hitters and they combined on Tuesday to strike out 15 batters against the best home-run hitting team in baseball.
- Gardner was batting .344 in his past 14 home games and his home run on Tuesday was his fourth at Yankee Stadium. Overall, Gardner is hitting .325 at home this season and he also leads the Yankees in bating with runners in scoring position at .315. Despite mostly batting in the leadoff spot, Gardner is tied with McCann and Yangervis Solarte for third on the team in RBIs with 28.
The Yankees probably could have done better than just six hits against Stroman and the Blue Jays relievers but with Tanaka on the mound it just does not seem to matter. The Yankees face the Blue Jays in five of the next 10 games. So winning the first one is a good start in cutting their lead in the division.
As expected on Tuesday, the Yankees activated catcher Francisco Cervelli from the 60-day disabled list and John Ryan Murphy was optioned back to Triple-A Scranton/Wilkes-Barre. Cervelli, 28, has been sidelined since April 13 with a torn right hamstring and just completed a 10-game minor-league rehab stint. Murphy, 22, hit .286 with a home run and eight RBIs and drew raves about his play over 24 games. Cervelli, however, was out of options and the Yankees did not want to risk losing him. . . . CC Sabathia reported no issues with his right knee of Tuesday after throwing a bullpen session at Yankee Stadium on Monday. Sabathia, 33, has been on the 15-day disabled list since May 11 after requiring a stem-cell injection to his knee when some degenerative breakdown in the cartilage was discovered by Dr. James Andrews. There is still no firm date for Sabathia's return but it likely will be sometime after the All-Star break.
The Yankees will continue their three-game midweek series with Blue Jays on Wednesday.
Rookie right-hander Chase Whitley (2-0, 2.41 ERA) will make his seventh start of the season. Whitley is 2-0 with a 2.45 ERA in past two starts including giving up just two runs on five hits with no walks and six K's in his major-league best 7 2/3 innings against the Seattle Mariners on Thursday.
Left-hander Mark Buehrle (10-3, 2.28 ERA) will pitch for the Blue Jays. Buehrle is coming off back-to-back losses and yielded four runs on eight hits and one walk in 6 1/3 innings against the Baltimore Orioles on Thursday.
Game-time will be 7:05 p.m. EDT and the game will be broadcast by the YES Network.
Jays Fall As Gardner Hits First Yankee Homer
The Yankees entered play on Sunday without a home run in their first five games. How can the Bronx Bombers be the Bronx Bombers when they are not hitting homers?
Well, it finally was taken care of by, of all people, Brett Gardner. The 30-year-old outfielder lined a 3-2 slider over the right-field wall in the fourth inning to give the Yankees a 6-1 lead and New York held on edge Toronto in front of a paid crowd of 34,067 at Rogers Centre.
Gardner's blast capped a three-run third inning after they had scored three runs on the first inning off right-hander Drew Hutchison (1-1).
It was just the fifth time since 1923 the Yankees have gone this far in to the season without hitting a home run and the first time since 1990 when Mel Hall hit the team's first home run in the eighth game of the season.
Meanwhile, left-hander CC Sabathia (1-1) rebounded from a bad first outing to record his first victory of the season.
The Yankees broke out on top early, taking advantage of Hutchison's poor command.
Hutchison walked Gardner to begin the game. Gardner then stole second and advanced to third on a Derek Jeter ground-out. He then scored on Jacoby Ellsbury's ground-out.
Brian McCann then drew a two-out walk and Hutchison hit Alfonso Soriano with a pitch. Kelly Johnson then laced a two-run double off the wall in center-field, which gave the Yankees an early 3-0 lead.
After former Yankee Melky Cabrera clubbed his third home run in three days against his former teammates to lead off the bottom of the first inning, Sabathia settled in and held the Blue Jays to only two more hits through the first five innings.
The Yankees added to their lead in the third when Hutchison walked Brian Roberts to start the frame. Roberts then stole second and he scored one batter later on an RBI double off the bat of red-hot rookie Yangervis Solarte, who was 5-for-12 with five RBIs in the three-game series.
Gardner then homered to give the Yankees a commanding 6-1 lead.
Hutchison gave up all six runs on six hits and three walks while he struck out six in 3 1/3 innings. Four of the six runs he gave up scored after reaching base without the benefit of a hit.
The Blue Jays did mount a two-out rally in the sixth inning off Sabathia to get back into the game.
Jose Bautista hit a bloop opposite-field single and Edwin Encarnacion followed with an opposite field single of his own. Dioner Navarro then slapped a double down the left-field line to score Bautista and Eric Kratz followed with a two-run single to center.
But Sabathia got Brett Lawrie out on a fly ball to center and relievers Adam Warren, Shawn Kelley and David Robertson protected Sabathia's lead the rest of the way to allow the Yankees to win the three-game series against the Blue Jays.
Sabathia gave up four runs on seven hits no walks and he struck out six in six innings.
Robertson did allow the Blue Jays to get the potential winning run to the plate with one out in the ninth when Lawrie singled and Robertson walked pinch-hitter Adam Lind. But Robertson retired pinch-hitter Colby Rasmus on an infield popup and Cabrera flied out to right.
Robertson earned his second save in two opportunities this season.
With the victory the Yankees evened their season record at 3-3. The Blue Jays fell to 3-4.
- Gardner's home run was only the 24th of his career but it was his fourth against the Blue Jays. Gardner may only be 5-for-18 (.278) this season but his on-base percentage is a sparkling .409. When the Yankees are struggling to hit home runs it is vital that Gardner get on base and use his speed to get into scoring position as he did on the first inning.
- Solarte has only started in four of the Yankees' six games but he is 8-for-15 (.533) with four doubles and five RBIs in those four games. There is a good chance that Solarte will cool off as opposing teams find out what his weaknesses are. But for now, Solarte looks to be the real deal and he is providing a spark to an offense that is not hitting on all cylinders yet.
- For a team struggling to hit with runners in scoring position, Johnson's two-out double in the first was huge. They were Johnson's first two RBIs of the season and it hopefully will get him started because he is just 4-for-18 (.222) in the early going.
- If it had not been for the sixth inning Sabathia would have had a very good outing. But the Blue Jays were able to take the veteran left-hander's pitches to the opposite field. In his first two starts, Sabathia has yielded 10 runs on 15 hits and one walk in 12 innings. His ERA stands at 7.50. He is going to have to do better than that if the Yankees are to contend in the American League East.
- Robertson is 2-for-2 in save situations but his work on Sunday was a bit shaky. Lawrie ripped a single up the middle and Robertson pitched too carefully to Lind and walked him. That allowed manager John Gibbons to go to his bench to use Rasmus and Cabrera has been the hottest hitter on the Blue Jays since spring training started.
- Though Soriano finally singled in the fifth inning off right-hander Todd Redmond, he is still 1-for-19 (.053) to start the season.
Jeter was 2-for-5 on Sunday and those two hits moved him past Paul Molitor for eighth place on the all-time hits list with 3,320. The 39-year-old team captain singled in the first inning off Hutchison to tie Molitor. He then singled again in the fourth inning to pass Molitor and he chased Hutchison from the game. Jeter is also fourth on the all-time American League hits list. . . . Francisco Cervelli took ground balls at first base on Sunday as manager Joe Girardi said the backup catcher could be called on to play first base while Mark Teixiera is on the 15-day disabled list with a strained right hamstring. Cervelli has never played first base but has appeared in four games at third base and two at second base.
After a opening week on the road the Yankees will play their home opener on Monday against the Baltimore Orioles.
Right-hander Hiroki Kuroda (0-1, 3.00 ERA) will get the start for the Yankees. Kuroda lost his first start on Wednesday against the Houston Astros despite yielding just two runs in six innings. The Yankees did not score any runs for him and he took a tough loss.
The Orioles will counter with right-hander Ubaldo Jimenez (0-1, 6.00 ERA). Jimenez was tagged for a pair of home runs in a loss to the Boston Red Sox on Wednesday. He is 1-1 with a 4.15 ERA in two starts at Yankee Stadium.
Game-time will be 1:05 p.m. EDT and the game will be broadcast nationally by the MLB Network and locally by the YES Network.
Yankees Knuckle Under To Dickey, Jays' Bullpen
The Yankees have been around enough to know that facing a knuckleball pitcher is always a 50-50 proposition. When the knuckleball is not working the game is easy. When it is working you can probably figure on losing.
R.A. Dickey held the Yankees scoreless for 6 2/3 innings and the three relievers who followed him completed the shutout as Toronto downed New York on Saturday in front of a sellout crowd of 45,446 at Rogers Centre.
Dickey (1-1) was shelled for six runs by the Tampa Bay Rays on Opening Day on Monday but he rebounded to yield only five hits and one walk while he struck out six to get credit for the victory on Saturday.
His mound opponent, Michael Pineda, was making his first major-league start since the end of the 2011 season and he deserved a better fate.
Pineda (0-1) held the Blue Jays to just one run on five hits, he did not walk a batter and he fanned five in six innings. He ended up on the short end because the Yankees could not solve Dickey or his knuckleball.
The Blue Jays lone run off Pineda came in the second inning when Adam Lind led off with a double and one batter later Josh Thole blooped a single into left to score Lind.
That run held up until the Blue Jays decided to play "Home Run Derby" in the eighth inning off reliever David Phelps. Melky Cabrera cranked a one-out solo shot, his second in two nights against his former teammates.
After Colby Rasmus stroked a ground-rule double, Jose Bautista blasted his third home run of the season to cap the scoring.
Sergio Santos pitched the final 1 1/3 innings for the Blue Jays to earn his second save.
The loss dropped the Yankees' season record to 2-3. The Blue Jays evened their record at 3-3.
- After Pineda missed two full major-league seasons recovering from shoulder surgery the Yankees have to be extremely pleased with what the 25-year-old right-hander did on Saturday. His fastball reached as high as 95 miles-per-hour. Even more important was that Pineda did not issue a walk. If Pineda is the team's No. 5 starter they have the makings of one of the best No. 5 starters in baseball.
- Yangervis Solarte continues to be impressive with the bat. The 26-year-old rookie was 2-for-3 with two singles and he is 7-for-13 (.538) on the young season. I was honestly stunned the Yankees would designate for assignment Eduardo Nunez to make room on the roster for Solarte. But now that they have made the move it looks like they made the right choice. The youngster is something special.
- Francisco Cervelli started behind the plate while Brian McCann was the designated hitter and Cervelli was 2-for-3 with a double and he threw out a runner on the bases. Jacoby Ellsbury, who was 3-for-4 on Friday, was 3-for-5 on Saturday. Cervelli, Ellsbury and Solarte combined to collect all seven of the Yankees' hits.
- The middle of the order had a really rough time with Dickey and the Blue Jays' relievers. Carlos Beltran, McCann, Alfonso Soriano and Kelly Johnson combined to go 0-for-16 with four strikeouts and they stranded nine base-runners. Beltran killed a big rally with no outs in the sixth after Ellsbury singled and Derek Jeter walked by hitting into a double play. After Ellsbury singled and and Jeter walked to start the eighth off left-hander Aaron Loup, Beltran struck out on a pitch that bounced in the dirt.
- It goes without saying that the Yankees were 1-for-11 with runners in scoring position. That hit came in the third inning after Cervelli had doubled and Ellsbury delivered a two-out single to center. However, Rasmus' throw to Thole at home plate beat Cervelli as he slid into home plate. That is pretty much the way the day went for the Yankees.
- Phelps gave up eight home runs in 86 2/3 innings last season. This season he already has given up three in 3 1/3 innings. Phelps, 27, needs to start doing a better job of keeping the ball in the yard.
Before the game started the Yankees placed first baseman Mark Teixeira on the 15-day disabled list with a strained right hamstring. Teixeira, 33, sustained the injury in the second inning of Friday's game against the Blue Jays as he tried to field a ground ball in foul territory. Teixeira will have an MRI on Monday in New York to determine the severity of the strain. To take his place on the roster the Yankees recalled catcher Austin Romine from Triple-A Scranton/Wilkes-Barre. Johnson will take Teixeira's place at first base and Solarte will take Johnson's spot at third.
The Yankees will try to win the three-game series against the Blue Jays on Sunday.
Left-hander CC Sabathia (0-1, 9.00 ERA) will start for the Yankees trying to atone for a horrible Opening Day start in which he gave up six runs in the first two innings to the Houston Astros before finishing with four scoreless innings.
Sabathia, 33, will be opposed by 23-year-old right-hander Drew Hutchison (1-0, 0.00 ERA), who shut out the Rays on three hits and three walks while striking out four in 5 1/3 innings in his 2014 debut.
Game-time will be 1:07 p.m. EDT and the game will be broadcast nationally by the MLB Network and locally by the YES Network.
Tanaka Bows To Pressure But Still Wins Debut
With the crush of American and Japanese media on hand and an unfriendly sellout crowd at Rogers Centre on Friday it was understandable if Masahiro Tanaka was a little nervous making his major-league regular season debut.
After Melky Cabrera deposited his third offering over the center-field wall reality set in. But Tanaka gradually overcame his nerves and settled in to win his first game in the United States as New York pounded out 16 hits to defeat Toronto in front of paid crowd of 48.187.
Tanaka (1-0) actually lost a 2-1 lead in the second inning when two hits and an error loaded the bases and Jonathan Diaz touched him for a two-run single. But after that hit, the 25-year-old right-hander retired 16 of the next 18 batters he faced, striking out six of them to allow the Yankees to come back and win the game.
Tanaka's final line was excellent. He allowed three runs (two earned) on six hits and no walks and he struck out eight batters in seven innings.
"I was missing some spots earlier in the game, but as the game progressed, I think I was getting better out there," Tanaka told reporters through an interpreter. "Obviously I'm happy. I think No. 1 is that I'm relieved."
Meanwhile, the Yankees' offense was once again sparked by rookie infielder Yangervis Solarte, who was 3-for-3 with two runs scored and an RBI in his major-league debut against Houston Astros on Thursday.
With the Yankees trailing 3-2 in the third inning, Brian Roberts drew a one-out walk from Blue Jays right-hander Dustin McGowan (0-1) and stole second. One out later, Ichiro Suzuki bound a ground ball to Ryan Goins at second base and Suzuki was called out on a close play at first.
However, manager Joe Girardi successfully overturned first-base umpire Dana Demuth's call through a instant-replay challenge, which put Roberts at third and Suzuki at first for Solarte.
The 26-year-old switch-hitter Solarte then laced a two-run double to right-center to give the Yankees a lead they would never relinquish.
That hit also ended McGowan's evening. The 32-year-old right-hander, who was making his first major-league start since 2011, was charged with four runs on eight hits and a walk while he struck out three in 2 2/3 innings.
The Yankees took an early 2-0 lead against McGowan in the first inning as Jacoby Ellsbury, who was 3-for-4 with a walk, stole two bases and scored two runs in the game, cranked a double to deep center. Brett Gardner advanced him to third on a hard-hit single to left.
Carlos Beltran then scored Ellsbury with a bloop single to left-center and Mark Teixeira scored Gardner with a single to right.
The Yankees only bad news of the evening came in the third inning as the Blue Jays took the lead against Tanaka. Teixiera injured his right hamstring while moving to field a foul ball. He was forced to leave the game and his immediate status is unclear.
The Yankees padded their lead in the fourth when Brian McCann scored Ellsbury with a one-out RBI single off left-hander Aaron Loup after the Blue Jays elected to intentionally walk Beltran to face the lefty swinging McCann.
They added single runs in the eighth on Gardner's RBI single off right-hander Steve Delabar and in the ninth on another RBI double by Solarte off right-hander Jarred Jeffress.
With the victory, the Yankees evened their season record to 2-2. The Blue Jays fell to 2-3.
- Tanaka's ability to recover from the mistakes he made pitching to Cabrera and Diaz are a testament to the fact he is not just a thrower. Tanaka knows how to pitch and make adjustments at a very young age. That attribute actually may be just as valuable as his split-finger fastball. The $155 million the Yankees invested in him may end up being a bargain. He is that good.
- After two games, Solarte is 5-for-10 (.500) with three doubles and two runs scored. He also leads the team in RBIs with four. If Teixeira is sidelined for any length of time it is a pretty good bet that Kelly Johnson will move from third base to play first and Solarte will become the starting third baseman. The Yankees may have found a real gem in this youngster.
- Ellsbury showed what he can do from the leadoff spot on Friday. His two doubles, two stolen bases and two runs scored really set the tone for the evening. To top it all off, Ellsbury also made a nice sliding catch of Dioner Navarro's sinking line drive in the sixth inning.
- Teixeira's injury exposes the weakest area on the Yankees' roster. Johnson is not an experienced first baseman and he will be asked to fill in while Teixiera is out. The Yankees do have corner infielder Russ Canzler at Triple-A Scranton/Wilkes-Barre but he is not anywhere close to Teixeira in offense or defense. he also is not on the 40-man roster. The Yankees have to hope Teixiera is not sidelined for an extended period of time.
- Dellin Betances was brought in to the game in the eighth to face Jose Bautista with two out and a four-run lead. He walked him. Although he got out of the inning by retiring Edwin Encarnacion, he opened the ninth by walking Adam Lind on four pitches that were nowhere near the strike zone. Girardi then summoned David Robertson to close out a game in which he should not have had to appear. Betances has had control issues in the past so he bears watching.
Teixeira will be re-evaluated on Saturday but it is highly unlikely he will play. The strain is is considered mild but Teixeira is scheduled to have an MRI on the right hamstring in New York on Monday. Teixeira played in only 15 games last season before having to undergo surgery to repair a torn sheath in his right wrist. . . . After Solarte got his first major-league hit in his debut on Thursday, Dean Anna singled in the ninth inning in his first major-league start on Saturday. Anna, 27, was in the lineup at shortstop to give Derek Jeter a rest. Anna was 1-for-4 with a walk and scored a run.
The Yankees wil continue their three-game series with the Blue Jays on Saturday.
After trading top prospect Jesus Montero to the Seattle Mariners before the 2012 season the Yankees will finally see Michael Pineda on the mound for them in a major-league game. Pineda, 25, was 2-1 with a 1.20 ERA and 16 strikeouts in 15 innings this spring after missing almost two seasons due to shoulder surgery to repair a torn labrum.
He will be opposed by right-handed knuckleball specialist R.A. Dickey (0-1, 10.80 ERA), who was out of sync in his 2014 debut against the Tampa Bay Rays on Monday. Dickey walked six batters and ended up surrendering six runs on five hits in five innings.
Game-time will be 1:07 p.m. EDT and the game will be broadcast by the YES Network.


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Over his two decades with the Johnstown Police Department Lt. David Gilbo has investigated many crimes, but until last month he was never put in charge of recovering a single coffeemaker. "I've investigated coffeepot thefts as parts of larger burglaries," he said, "but never like this." On April 9, Fulton County District Attorney Louise Sira noticed the Keurig coffeemaker kept by her office in the county office building grand jury meeting room was missing. A ...
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Firefox 3.6: Speed, Look, and Video
The Mozilla Firefox 3.6 browser is now available and provides performance improvements and numerous technical enhancements.
TThe TraceMonkey JavaScript engine used in the new release is supposed to be 3x faster than in Firefox 3.0 and 20 percent faster than in 3.5. To mitigate security risks from older plugins, the project suggests removing them before installing 3.6.
The new browser version now provides audio and video output in Ogg Theora format according to HTML 5 specifications, and in full picture mode with videos. Also new are CSS color profiles that no longer drop colors from background images as before. Furthermore, Web Open Font Format (WOFF) support serves in loading fonts more quickly.
The new browser also includes a new drag-and-drop API and an interface for location and motion sensing, much like what is built into MacBooks. Annding an individual persona to your browser is now easier, too.
Mozilla's Mike Beltzner, director of Firefox development, demos the new features in a two-minute YouTube video.
Firefox 3.6 is available in numerous languages and for download to multiple platforms.
Issue 194/2017
Buy this issue as a PDF
openSUSE Rolls Out 42.2 Leap
New release targets Linux professionals.
Cutting-Edge Fedora 25 Released
The Fedora project adds Wayland and Gnome 3.22
CeBIT 2017: The Open Source Forum
CeBIT 2017: Open Source Forum Call for Papers
Say it Ain't So! Microsoft Joins the Linux Foundation
Long-time Linux antagonist joins the revolution.
How to Bypass Authentication on a Linux System
Major bug affects Debian/Ubuntu distributions.
Ubuntu Core 16
Canonical releases the minimal edition for embedded devices, Internet of Things, and cloud deployments.
Red Hat Releases Red Hat Enterprise Linux 7.3
The new release features improvements across the board, from performance to security.
The Linux Foundation Announces a New Board of Directors
Two out of three of the new members are women.
OpenStack Summit in Barcelona
More than 5,000 people attended the event.
Linux Voice Joins the Linux New Media Family
Linux Magazine will include the best of both magazines.


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As many bloggers have pointed out, yes, we did drop the ball on this story. That's the bottom line and we're not denying it. Here's how the great non-National Science Fair story came about:
Our niche as a community newspaper is covering the news of Bee County. We will no doubt publish hundreds of student awards stories this year – from spelling bees to UIL musical solos to football and welding competitions. This is what we do and don't mind sharing the good news about kids doing well.
So our reporter takes a call from the principal at R.A. Hall Elementary School and is asked to come take a picture and write up a story on a fourth-grader who has won the junior division of the National Science Fair. That's a good story in a small community, so off the reporter goes.
There with the school principal are the student and her father, who is a community member of note having been appointed to the school board and running for that post in 2008. They've got a letter, an engraved plaque, trophy and medal. The reporter takes the picture, gathers quotes, grabs a copy of the letter and heads back to the office to file this as one of her many stories for the week.
Now this is a drill we replicate multiple times a week. It's not a situation where our first thought is to send out an investigative reporter. We're looking at it in the context of a local student makes good, not through the prism of a blogging battleground for, or against, global warming.
As the story progressed through editing, its oddities did register somewhat with the idea of exploring the ironies in a more detailed follow-up story, including some portion of the project itself.
It's not in our normal protocol to phone foundations every time a student receives an award or scholarship – particularly when the news comes through the schools. With the advantage of hindsight and several days to reconsider events, we certainly should have done so in this case.
As today's story demonstrates, there are still many unanswered questions and things that don't add up in this bizarre episode. We're still not sure where it yet ends.
To our readers, we owe a mea culpa. To the bloggers, a thank you for the assist (and head slaps).


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Mathias, Anita A PhD*; Hinkle, John PhD*; Menning, Mark PhD*; Hui, James PhD*; Kaul, Sanjeev PhD†; Kearney, Brian P PharmD*; for the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen Development Team
From *Gilead Sciences, Foster City, CA; and †Bristol-Myers Squibb, Princeton, NJ.
Received for publication March 2, 2007; accepted June 14, 2007.
Presented in part as a poster at the XVI International AIDS Conference, Toronto, Ontario, Canada, August 13-18, 2006 and in part as a podium presentation at Seventh International Workshop on Clinical Pharmacology of HIV Therapy, Lisbon, Portugal, April 20-22, 2006.
Correspondence to: Anita A. Mathias, PhD, Clinical Research Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404 (e-mail: email@example.com).
Objective: Efavirenz (EFV; 600 mg), emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg) are preferred agents for treatment of HIV-1 infection in adults. This study evaluated the pharmacokinetics (PK) and bioequivalence of an investigational coformulation of EFV/FTC/TDF (test) single-tablet regimen compared with the commercially available individual dosage forms (EFV+FTC+TDF; reference treatment) in healthy subjects.
Methods: Subjects were randomized to 1 of 2 treatment sequences (test→reference or reference→test) in an open-label crossover study design. Study drug was administered under fasted conditions, and serial blood samples were obtained over 504 hours after oral administration of each treatment. Formulation bioequivalence was assessed in accordance with the US Food and Drug Administration bioequivalence criteria.
Results: Forty-eight subjects were enrolled, and 45 completed the study, with all study treatments being generally well tolerated. For EFV (n = 44), the geometric mean ratios (90% confidence interval [CI]) for maximum concentration (Cmax), area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last), and area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) were 99.9 (93.4 to 107), 95.7 (90.5 to 101), and 95.2 (88.9 to 102), respectively. For FTC (n = 45), the geometric mean ratios (90% CI) for Cmax, AUC0-last, and AUCinf were 88.8 (84.0 to 93.9), 98.0 (94.9 to 101), and 98.0 (94.9 to 101), respectively. For tenofovir (n = 45), the geometric mean ratios (90% CI) for Cmax, AUC0-last, and AUCinf were 91.5 (84.6 to 98.8), 99.3 (91.0 to 108), and 100 (93.2 to 108), respectively.
Conclusions: The coformulation of EFV/FTC/TDF is bioequivalent to administration of its individual components.
Therapeutic strategies for treatment of HIV-1 infection have been markedly improved by the availability of potent combination highly active antiretroviral therapy (HAART), making it possible to suppress HIV-1 replication and reduce plasma HIV-1 RNA to undetectable levels.1-3 However, many patients exhibit incomplete viral suppression despite the availability of highly effective antiretroviral therapies.4-6 Successful long-term treatment of HIV/AIDS requires exceptionally high levels of adherence to therapy to prevent emergence of drug-resistant HIV variants with reduced susceptibility that leads to treatment failure and risk for disease progression.7,8 Incomplete adherence to the drug regimens is often a consequence of their complexity, frequent, and often discordant dosing intervals and side effects; therefore, strategies to simplify regimen adherence are desirable, particularly for first-line regimens, where adherence considerations are important determinants of treatment outcomes, including reduction of HIV-related morbidity and mortality.6,9 Availability of fixed-dose combinations such as the nucleoside/nucleotide combination of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) and other nucleoside combinations (eg, zidovudine/lamivudine [ZDV/3TC], abacavir sulfate/3TC, ZDV/3TC/abacavir sulfate) offer partially simplified treatment regimens by reducing pill burden and dosing frequency of the nucleoside backbone of HAART regimens.
Current clinical practice guidelines recommend the regimen of efavirenz (EFV), a nonnucleoside reverse transcriptase inhibitor (NNRTI), plus FTC and TDF nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/NtRTIs) as preferred agents for initial antiretroviral therapy for HIV-1 infection in adults.10-12 The combination of EFV, FTC, and TDF has demonstrated durable efficacy and safety in long-term controlled clinical trials.13-15 Long plasma half-lives of EFV, FTC and tenofovir (TFV) and longer intracellular half-lives of active anabolites of TFV and FTC make these agents amenable for once-daily dosing.16-18 Recently published data from Gallant et al15 have demonstrated that the combination of EFV, FTC, and TDF provides superior outcomes in terms of virologic suppression, CD4 cell response, and adverse events in treatment-naive patients compared with the previous gold-standard regimen of fixed-dose ZDV/3TC plus EFV.
The 25 years since the beginning of the HIV epidemic have seen the development of more than 20 antiretrovirals including 10 years of HAART; however, no simple single-tablet, once-daily, fixed-dose, standard-of-care regimen is available for patients. Therefore, with the goal of simplifying antiretroviral therapy, facilitating adherence, and optimizing durable treatment responses for patients, Gilead Sciences (Foster City, CA) and Bristol Myers Squibb (Princeton, NJ) have collaborated to develop a single, once-daily, fixed-dose, triple-combination tablet of EFV, FTC, and TDF. The current study was conducted to establish the bioequivalence of the fixed-dose, triple-combination, single-tablet regimen as compared with the commercialized individual dosage forms.
A total of 48 healthy male and female subjects (nonpregnant and nonlactating) between 18 and 45 years of age and with a measured body weight within ±15% of the protocol-specified range (as defined by 1999 Metropolitan Height and Weight Tables) were enrolled in the study. To rule out pregnancy, female subjects of childbearing potential had pregnancy tests (urine and plasma) at screening, before administration of study drug(s), and at several specified time points within the study. Laboratory values for all subjects had to be within the normal range, or if they were outside this range, deviations had to be assessed for clinical insignificance by the principal investigator and medical monitor. Subjects were excluded if they had a history or current manifestations of clinically significant diseases/disorders or were receiving any prescription medication (30 days before study) or over-the-counter medication and herbal product (2 weeks before commencement of study), with the exception of vitamins, acetaminophen, and/or hormonal contraceptives (oral, implant, patch, or injections). The prohibition toward use of medication(s) before commencement of study was extended to 60 days if the drug(s) exhibited an elimination half-life >10 days and to 30 days for drug therapy known to induce or inhibit hepatic drug metabolism. Additional restrictions included consumption of grapefruit juice or grapefruits 1 week before receiving study medication and until completion of the study. Subjects with a history of active alcohol or chemical dependency were excluded. The principal investigator reviewed medical histories and clinical laboratory evaluations and performed physical examinations before a subject's enrollment in the study.
Because EFV is assigned to US Food and Drug Administration (FDA) pregnancy category D, additional precautionary measures were implemented during the study to avoid/minimize the risk of developing pregnancies. Female participants of childbearing potential (ie, not surgically sterile or at least 2 years postmenopausal) were required to agree to use highly effective contraception methods while on study treatment and for 2 months after the last dose of study drugs. Highly effective methods included 2 separate forms of contraception, 1 of which was required to be an effective barrier contraceptive method. Female subjects using a hormonal contraceptive as a birth control method were required to have used the same method of contraception for at least 3 months before study dosing. Male subjects who were sexually active were required to use 2 forms of barrier contraception from screening through completion of the study and continuing for at least 30 days from the date of last dose of study drug and to refrain from sperm donation from day 1 through at least 30 days after the last dose of study drug.
Informed consent was obtained from each study participant. The protocol was approved by the MDS Pharma Services Institutional Review Board (Phoenix, AZ) before study initiation. The study was carried out in accordance with the clinical research guidelines established by the basic principles defined in the U.S. 21 CFR Part 312.20 and the principles enunciated in the latest version of the Declaration of Helsinki.
In accordance with FDA guidance for conducting bioavailability and bioequivalence studies for orally administered drug products, healthy subjects were investigated in this study.19 This allowed for removal of confounding effects of background antiretroviral and other therapies and avoidance of the potential for multiple short-term changes in treatment regimens of HIV-infected patients for the sole purpose of examining pharmacokinetic (PK) parameters.
This was a randomized, single-dose, open-label, 2-way, crossover study. The fixed-dose single-tablet regimen containing 600 mg of EFV, 200 mg of FTC, and 300 mg of TDF (EFV/FTC/TDF; test) was compared with concurrent administration of individual dosage forms of 600 mg of EFV, 200 mg of FTC, and 300 mg of TDF (EFV+FTC+TDF; reference treatment) to healthy adults under fasted conditions. All subjects received test and reference treatments. The duration of the study was 50 consecutive days and consisted of 2 periods: period 1 (day 1 to 28) and period 2 (day 29 to 50).
Subjects were randomized to 1 of 2 study treatment sequences (test→reference or reference→test). A single dose of study drug(s) was administered on days 1 and 29 under fasted conditions (8-hour fast). Mouth checks were performed after each dosing to ensure that subjects had ingested all study medication. Subjects continued fasting until after the 4-hour PK blood sampling time point.
Serial blood samples for PK assessments were collected over a 21-day (504-hour) period from days 1 to 22 and days 29 to 50 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336, and 504 hours after oral administration of each treatment. The number, frequency, and timing of blood samples were based on the concentration-time profiles of the individual drugs to assess bioequivalence accurately based on maximum concentration (Cmax) and area under the concentration-time curve (AUC). An additional washout period of 1 week was introduced after the last blood sample draw in period 1 because of the long half-life of EFV.20 The blood samples were centrifuged, and plasma collected was frozen at −20°C until analysis.
The use of any prescription or over-the-counter medication, including those contraindicated in the individual drug(s) prescribing information, was prohibited during the study. Any concomitant medications that were required to be administered during the study needed review and approval from the sponsor.
Safety was evaluated by assessment of clinical laboratory tests at baseline and at various time points during the study; by periodic physical examinations, including vital signs; and by documentation of adverse events throughout the study. Subjects were also contacted by telephone 7 days after the last PK visit to inquire about any new adverse events. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 8.0. Adverse events and abnormal laboratory values were graded according to the Gilead Sciences Modified National Institute of Allergy and Infectious Diseases (NIAID) Common Toxicity Grading Scale (mild = 1, moderate = 2, severe = 3, and possibly life-threatening = 4).21
EFV, FTC, and TFV concentrations in human plasma were determined by a validated high-performance liquid chromatography/mass spectroscopy/mass spectroscopy (HPLC/MS/MS) assay. Briefly, the methodology was as follows: 100 μL of human plasma was deproteinized using methanol solution spiked with internal standard (IS). After extraction, EFV (IS: reduced EFV), FTC (IS: 3TC) and TFV (IS: adefovir) were resolved on reverse-phase chromatographic system under isocratic conditions, with a lower limit of quantitation of 5 ng/mL for EFV and FTC and 10 ng/mL for TFV. EFV and reduced EFV were detected in the selected reaction monitoring (SRM) mode using atmospheric pressure chemical ionization (APCI) with negative polarity and the following ion transitions: m/z 314→m/z 244 for EFV and m/z 286→m/z 216 for reduced EFV. FTC, TFV, and their ISs were detected in the SRM mode using electrospray ionization (ESI) with positive polarity and the following ion transitions: m/z 248→m/z 130 for FTC, m/z 288→m/z 176 for TFV, m/z 230→m/z 112 for 3TC, and m/z 274→m/z 162 for adefovir. Calibration curves for EFV and TFV were obtained using a linear regression algorithm of the peak area ratio of each analyte to its IS versus concentration. Calibration curves for FTC were obtained using a quadratic regression algorithm of the peak area ratio of FTC to 3TC versus concentration. The precision and accuracy in the assay validation were evaluated using 3 separate analytic runs, with each containing quality control (QC) samples (n = 4) in replicates of 5 for FTC and TFV and replicates of 6 for EFV. Inter- and intra-assay precision had a <13% coefficient of variation, and accuracy was within 16% of expected.
The PK analysis set for each analyte comprised all randomized subjects who received study drug and completed both PK sampling sessions. For analyses, all predose sample times of less than time 0 were converted to 0. Values less than the lower limit of quantitation in bioanalytic assays that occurred before the first quantifiable concentration were assigned a value of 0 to prevent overestimation of the initial AUC. Samples less than the lower limit of quantitation at all other time points were treated as missing data to avoid bias in the estimation of the terminal elimination rate constant. In accordance with FDA guidance for bioequivalence studies, subjects with a predose drug concentration in period 2 of >5% of Cmax or who experienced emesis at or before 2 times the median time to maximum concentration (Tmax) for the analyte were excluded from the PK analysis set.19
The plasma concentration-time data after oral administration of a single dose(s) of test and reference treatment were analyzed using a noncompartmental method (WinNonlin, version 5.0.1; Pharsight, Mountain View, CA) to estimate the area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last), area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf), Cmax, last quantifiable concentration (Clast), Tmax, time of Clast (Tlast), and terminal elimination half-life (T½).
For a 2-period crossover design, a total of 48 enrolled subjects (targeting 38 evaluable subjects for PK, with 19 subjects per sequence) were estimated to provide 90% power at the 5% significance level to reject the null hypothesis of lack of equivalence in favor of the alternative hypothesis of equivalence with regard to Cmax, AUC0-last, and AUCinf. Power was based on findings from previous studies (EFV, FTC, and TFV data on file, Gilead Sciences) and was determined by the within-subject SD of logarithmic transformed Cmax (0.211 for EFV, 0.198 for FTC, and 0.288 for TFV). Because equivalence on all primary endpoints was needed to declare overall bioequivalence between the test and the reference formulations, additionally, an estimate of overall "effective" power was determined by multiplying together the individual estimated power (for demonstrating equivalence) of each comparison. Effective power analyses estimated that 38 subjects (19 per sequence) would provide at least an 88% probability that bioequivalence was supported if the true geometric mean ratio (test/reference) was 1.00 for all endpoints and at least a 77% probability that bioequivalence would be supported if the true geometric mean ratio (test/reference) was 1.05 for all endpoints.
Demographic data and PK parameters were summarized by treatment using descriptive statistics. For each analyte (EFV, FTC, and TFV), the bioequivalence for primary PK parameters (Cmax, AUC0-last, and AUCinf) was analyzed using natural log-transformed values. These PK values were compared between the test and reference treatments by an analysis of variance (ANOVA) using SAS PROC MIXED (SAS Institute, Cary, NC) appropriate for a 2-treatment crossover design. The mixed-effects model included the following fixed effects: sequence, period, and treatment; it also included a random effect: subjects-within-sequence. In accordance with scientific standards and international guidelines for bioequivalence studies, formulation bioequivalence was concluded if the 90% confidence interval (CI) for the ratio of the geometric least-squares means (test treatment/reference treatment) was within the bounds of 80% to 125% for the primary PK parameters (Cmax, AUC0-last, and AUCinf) for all analytes.19,22
Forty-eight healthy subjects received at least a single administration of the test or reference treatment. Forty-five subjects received the test treatment, whereas 48 subjects received the reference treatment. The ethnic background of subjects was as follows: 90% Hispanic, 6% white, 2% American Indian, and 2% black. There was a greater proportion of female (73%) than male (27%) subjects. The mean (SD) age was 30 (7.1) years, mean weight (SD) at screening was 65.2 (7.15) kg, mean height (SD) was 163.3 (8.01) cm, and mean (SD) body mass index (BMI) was 24.5 (2.45) kg/m2 (24.3 kg/m2 for female subjects and 24.8 kg/m2 for male subjects). Forty-five subjects completed the study; 3 subjects were discontinued by the investigator for protocol violations (2 pregnancies and 1 positive drug test).
EFV, FTC, and TDF administered once daily in a fixed-dose combination tablet or as individual drugs given concurrently were generally well tolerated by the study subjects. Treatment-emergent adverse events were reported in 21 (46.7%) of 45 subjects after administration of the test treatment compared with 25 (52.1%) of 48 subjects receiving the reference treatment. Adverse events reported included central nervous system effects (primarily headache and dizziness) as the most frequent drug-related adverse events in 24.4% (test) to 29.2% (reference) of subjects. Gastrointestinal disorders (primarily nausea, abdominal pain, lower abdominal pain, and diarrhea) were the second most frequent treatment-emergent adverse events in 17.8% (test) to 16.7% (reference) of subjects. The adverse events were mild and transient and consistent with events commonly associated with EFV, FTC, and TDF.23-25
Two serious adverse events occurred during the study. Two female subjects had spontaneous abortions in the first trimester of pregnancy, and the subjects were discontinued from study during dosing period 1. Both subjects became pregnant on study after administration of the reference treatment on day 1 despite consensual agreement to all warnings and precautions relevant to pregnancy and explicit protocol requirements of contraception to avoid pregnancy. Details on these subjects were added to the antiretroviral registry to track the outcome of the pregnancy.
The PK analyses data set for EFV included 44 subjects, whereas the data set for FTC and TFV included 45 subjects. One subject had predose concentrations of EFV >5% of period 2 Cmax and was not included in the PK analysis criteria for EFV. Mean (SD) EFV, FTC, and TFV plasma concentration-time profiles are presented in Figure 1 (A-C, respectively). The derived plasma PK parameters for EFV, FTC, and TFV were similar after administration of the test or reference treatment throughout the monitoring period. Plasma PK parameters for EFV, FTC, and TFV after dosing of the test or reference treatment are summarized in Table 1, Table 2, and Table 3, respectively.
Statistical analyses of EFV, FTC, and TFV PK parameters after administration of the test or reference treatment are presented in Table 4. The ratios of the geometric means (%) of all primary PK metrics for EFV, FTC, and TFV were close to 1 (100%), and the corresponding 90% CIs around the ratio were contained within the bioequivalence bounds of 80% to 125%, indicating that the plasma PK parameters of EFV, FTC, and TFV after administration of the test treatment or reference treatment were bioequivalent.
The EFV/FTC/TDF coformulated single-tablet regimen and coadministered EFV+FTC+TDF did not differ with respect to the median Tmax or T1/2 value. As seen in Tables 1, 2, and 3, the amount of area under the curve that occurred after the last quantifiable sampling time point (%AUCexp) for any analytes was <17%, demonstrating adequate sampling and accurate estimation of the elimination phase and its rate constant. The mean [SD] apparent oral clearance (mL/h/kg) of EFV in these healthy subjects for the test (70.0 [21.7]) and reference (67.1 [23.6]) treatments was consistent with historical data (Bristol-Myers Squibb, data on file).
The results of this study demonstrate that the EFV/FTC/TDF fixed-dose, single-combination, single-tablet regimen is bioequivalent to the administration of commercially available EFV, FTC, and TDF, each of which is a preferred agent in the treatment guidelines for HIV infection in adults by the Department of Health and Human Services.10-12,26,27
All 3 agents of this regimen were developed to be administered once daily, and their long plasma (EFV ∼40 to 55 hours25) or intracellular (FTC ∼39 hours28 and TFV ∼>60 hours16) half-lives are complementary. In a large prospective trial with 517 treatment-naive patients, Gallant et al15 have demonstrated over 48 weeks that the combination of EFV, FTC, and TDF fulfilled the criteria for noninferiority to the well-established fixed-dose regimen of ZDV/3TC and EFV and proved superior in terms of virologic suppression, CD4 cell response, and adverse events resulting in discontinuation of the study drugs. The superior outcome in that study supports the use of EFV, FTC, and TDF as a standard-of-care regimen for treatment-naive patients starting therapy or for switching patients on this or other EFV-containing regimens. Offering this treatment in a single-tablet regimen provides the benefit of a simple regimen to facilitate adherence and lead to improved treatment outcomes.
Three previous formulations of the fixed-dose triple-combination tablet comprising an admixture of the 3 individual components had been developed using traditional dry and wet granulation methodologies; however, all 3 failed to demonstrate bioequivalence compared with the individual dosage forms. Factors such as high doses of active drugs, the low solubility/high permeability properties of EFV (Biopharmaceutics Classification System [BCS] class II), and chemical stability of TDF and FTC contributed to the difficulties in developing a coformulated single tablet. Formulation and process modifications were implemented, including bilayer tableting, to increase the dispersibility, absorption, and exposure of EFV in the fixed-dose combination tablet and to minimize potential physical and chemical interactions of EFV, FTC, and TDF. The proposed commercial formulation of the fixed-dose tablet that was assessed in this study is a bilayer film-coated tablet containing excipients such as croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. This design was proposed to increase the dispersibility of EFV and to enhance systemic exposure. This formulation was approved for commercialization in the United States by the FDA in July 2006 and is currently under regulatory review in the European Union and other countries.
Single doses of EFV, FTC, and TDF administered once daily in a fixed-dose triple-combination tablet or as individual drugs given concurrently were generally well tolerated by the study subjects. Adverse events reported included nervous system effects and gastrointestinal disorders; however, most events were mild and transient and consistent with events commonly associated with EFV, FTC, and TDF. In conclusion, the fixed-dose combination of EFV/FTC/TDF was bioequivalent to the individual dosage forms administered concurrently and is the first single-tablet, once-daily, complete antiretroviral regimen for the treatment of HIV-1 infection.
This article has been cited 3 time(s).
bioequivalence; efavirenz; emtricitabine; fixed-dose combination; tenofovir disoproxil fumarate
© 2007 Lippincott Williams & Wilkins, Inc.
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Rogart, Jason N. MD*,†
*Capital Health Center for Digestive Health, Pennington
†Division of Gastroenterology, Robert Wood Johnson Medical School, University of Medicine and Dentistry, New Brunswick, NJ
The author declares that there is nothing to disclose.
Reprints: Jason N. Rogart, MD, Director of Interventional Gastroenterology & Therapeutic Endoscopy, Capital Health Center for Digestive Health, Two Capital Way, Suite 380, Pennington, NJ 08534 (e-mail: email@example.com).
It has been estimated that 44,000 new cases of pancreatic cancer will be diagnosed and 37,000 deaths will occur in 2012.1 The vast majority of these patients are unresectable and consequently suffer from substantial morbidity, including obstruction of the distal bile duct. In patients with pancreatic head cancer, as well as those with other cancers that result in biliary obstruction (eg, cholangiocarcinoma and ampullary adenocarcinoma), endoscopic treatment is often successful in alleviating symptoms, reducing the risk of cholangitis, and improving biliary drainage so that hepatically metabolized chemotherapeutic agents can be used safely.2 Furthermore, over the past decade, there has been a preponderance of data suggesting that endoscopic placement of a self-expandable metal stent (SEMS) in nonresectable patients or in those whose surgical status is uncertain is cost-effective.3,4
Unfortunately, in a certain percentage of patients with malignant biliary obstruction, conventional endoscopic placement of an SEMS is not feasible because of the inability to perform, or the failure of, endoscopic retrograde cholangiography (ERC). Usually this occurs when the ampulla is inaccessible because of duodenal obstruction from an invading tumor, or when cannulation of the major papilla is unsuccessful. When these situations are encountered, conventional options include either surgical biliary bypass or percutaneous transhepatic biliary drainage (PTBD). During PTBD, the goal of the interventional radiologist is to either percutaneously place a SEMS or, if not feasible, place an external drainage catheter, with the hopes of internalizing it in the future. PTBD, however, is a more invasive procedure than endoscopy and carries with it a complication rate of up to 30%.5
Over the past few years, another option has been increasingly reported in small case series: endoscopic ultrasound (EUS)-guided access to the bile duct. Intuitively, to endosonographers, this makes sense, as the extrahepatic bile duct is visualized in exquisite detail with EUS and is only a short distance away from the duodenal wall. Furthermore, the therapeutic, linear-array echoendoscope has an oblique-viewing lens, a large working channel, and an elevator to help direct devices, much like a duodenoscope used for ERC. In this issue of the Journal of Clinical Gastroenterology, Artifon and colleagues present the first prospective, randomized study comparing EUS-choledochoduodenostomy (EUS-CD; placing an SEMS through the duodenal wall into the bile duct) with conventional PTBD.6 The authors are to be commended on 2 fronts: first, for comparing EUS-CD directly with PTBD, which as mentioned above is the most common "rescue" procedure for failed ERC, and, second, for using a technique that is quite straightforward and familiar to well-trained therapeutic endoscopists. In fact, the steps involved are nearly identical to those of EUS-guided pseudocyst drainage, including use of the same devices.
Artifon and colleagues randomized 25 unresectable patients with failed ERC or EUS-guided transpapillary rendezvous (of a total of 149 patients referred) to either EUS-CD or PTBD. Preprocedural characteristics of the 2 groups, including the size of their bile ducts and degree of hyperbilirubinemia, were similar. The technical success in both groups was 100% and outcomes were not statistically different between them, including the degree of improvement in serum bilirubin levels, length of hospital stay, quality of life, and low rate of complications. The overall complication rate in the EUS-CD group was 15%, and both cases were mild. There was only 1 bile leak. Although there was a trend toward lower costs of EUS-CD compared with PTBD, this was not statistically significant. Mean follow-up was fewer than 80 days, although the authors pointed out that this was largely because 76% of the patients were not alive at 3 months. The study reported no incidents of stent migration, presumably because of the exclusive use of partially covered SEMS, which likely has a lower risk of migration compared with fully covered SEMS.
Although the authors are to be commended on presenting the first randomized study comparing an "experimental" technique with an established technique for biliary drainage, the study's biggest weakness is that the numbers in each arm are small, and therefore the study is likely not adequately powered. In addition, the patient population appears to be highly selected and may represent more advanced disease than the average therapeutic endoscopist sees on a daily basis—for example, patients with very high bilirubin levels, nonresectable patients (borderline resectable patients were not included), and a high number of patients in whom standard ERC had failed (>25%). Nevertheless, the authors recognize that this is a pilot study and provide thought-provoking data suggesting that EUS-CD, in expert hands, may be a reasonable alternative to PTBD.
Hence, is EUS-CD ready for prime time? I think it may be close. It was first reported >10 years ago by Giovannini and colleagues, and since then several reports have demonstrated its safety and efficacy.7–20 In addition to being less invasive compared with its nonendoscopic alternatives,17,18 it certainly has many other benefits including use of familiar techniques and devices, the ability to be performed at the same session when ERC fails, immediate internal drainage, and advantages over PTBD, including lack of pain at the percuatenous site and avoidance of the inconvenience of an external drainage bag when an internal stent cannot be placed. Despite the enthusiasm, however, there are still many unanswered questions. First, and most obviously, will the positive data presented by Artifon and colleagues hold up in much larger, multicenter studies? Although randomized, this was a small, single-center study with 1 endoscopist performing all the procedures. Second, where does EUS-CD fit in with respect to other EUS-guided rescue procedures such as EUS-rendezvous (where EUS puncture of the bile duct is performed and a wire is passed antegrade through the papilla so that conventional ERC can be performed) or EUS access to intrahepatic ducts through the stomach?21 In addition, when the papilla is accessible, should EUS-CD be considered before needle-knife precut sphincterotomy? Third, can EUS-CD be used in patients for whom resectability is uncertain, or will it make a surgeon's task more difficult? Fourth, what is the optimal technique (Should a needle-knife be used? What should be the optimal size of the dilating catheter and/or balloon? Should a partially covered SEMS be utilized or a fully covered one?), and should we wait for better-designed scopes (eg, forward-viewing echoendoscope) or devices specifically tailored to this novel procedure (eg, shorter stents designed to better appose the duodenal and biliary walls)?
Despite all these questions, I have no doubt that EUS will have an increasingly important role in biliary access for malignant disease in the very near future, as many of us are already using some of these techniques (or seriously considering them) in select situations. Similar to the history of many endoscopic procedures including upper gastrointestinal endoscopy, colonoscopy, and ERCP, we have seen EUS transform, in a relatively short period of time, from a purely diagnostic procedure to a technology that is offering an increasing array of therapeutic possibilities such as fine-needle injection, pancreatic pseudocyst drainage, pancreaticobiliary access and stenting, and radiofrequency ablation. For a procedure whose future relevance and utility was questioned by many gastroenterologists not too long ago, EUS has surely arrived at the party.
© 2012 Lippincott Williams & Wilkins, Inc.
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|Topical fat reduction in specific areas of the body is a common concern for women. Ronsard popularized the term "cellulite" to describe the dimpling and "orange peel" external appearance of the thighs, the cause of which was attributed to the aging process by later researchers.
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My First Gun
Palestinians boys playing with their new toy guns on the Muslim holiday of Eid al Fitr, August 9, 2013.
According to Wikipedia, Eid al-Fitr marks the end of the fasting month of Ramadan, and has to do with the communal aspects of the fast, expressing many of the basic values of the Muslim community.
Now you know.Yori Yanover
About the Author: Yori Yanover has been a working journalist since age 17, before he enlisted and worked for Ba'Machane Nachal. Since then he has worked for Israel Shelanu, the US supplement of Yedioth, JCN18.com, USAJewish.com, Lubavitch News Service, Arutz 7 (as DJ on the high seas), and the Grand Street News. He has published Dancing and Crying, a colorful and intimate portrait of the last two years in the life of the late Lubavitch Rebbe, (in Hebrew), and two fun books in English: The Cabalist's Daughter: A Novel of Practical Messianic Redemption, and How Would God REALLY Vote.
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If he's not careful, political writer and contributor to Forbes and The Washington Monthly, regular commentator on Fox News, and friend of health insurance whistleblower and single-payer advocate Wendell Potter, might find squads of United Healthcare, Wellpoint, or Aetna thugs waiting for him around a corner.
First, he wrote a great column about how a provision in the Affordable Care Act (ACA) requiring insurance companies to spend 80% of income on actual health care (rather than million-dollar salaries for their CEOs, corporate jets, or lobbying) would lead to single-payer health care.
Then he wrote about the good news/bad news report of a decrease in medical spending since 2010. He writes, "The headline is that health care spending grew at only 3.9 percent in 2010—just .1 percent more than the rate of growth in 2009. Combine the numbers from 2009 and 2010 and we're looking at the slowest two-year rate of growth since the Center for Medicare & Medicaid Services (CMS) began keeping tabs on these numbers 51 years ago. play online bingo ipad
"So, why am I feeling so "blah" about it all?
"Because as much as I would like to believe that the results are due to good government or the private markets making some sort of change to bring down the out-of-control advancement in the costs of medical care, I know very well that the real reason we spent less is because we simply had less to spend.
"When people aren't working; when people are uninsured; and when people are under-insured, you don't have to be a trained actuary to understand that people are forced to put their medical issues and concerns to the side and hope for the best. Thus, there is less spending on medical care because there are fewer people with enough insurance coverage or money in their pocket to pay for the care they need." top online casino promotions spartan slots
I can personally attest to that. In 2009, my co-pay to see any doctor was $10 per visit. I spent almost 12% of my income on health insurance and health care in 2009, though I had the "gold standard" Blue Cross Blue Shield PPO.
In 2010, co-pays doubled to $20 to see my primary care doc and quadrupled to $40 to see any of the five "specialists" I'm supposed to see at least once a year. I stopped seeing my primary care doc every three months for monitoring of my Type II diabetes, blood pressure, and primary biliary cirrhosis, cutting back to every six months. Because $40 is half my weekly food budget, visits to my ophthalmologist, dermatologist, rheumatologist, podiatrist, chiropractor, and orthopedic surgeon were eliminated. The only specialist I saw in 2011 was my retina specialist because I admit to being scared as hell of going blind. He was kind enough to squeeze in the laser surgery necessary for macular edema on the same day, so that I wouldn't have to pay a separate co-pay. So my percentage spent on insurance and health care in 2011 went down to about 7%. sky king online casino
Thankfully, I'm not in any new pain, noticing new symptoms, or seeing elevations in blood sugar or pressure. I also switched from the PPO to an HMO in October – even though the co-pays are still high, I now only pay $20 per paycheck, rather than $100, for the premium. Of course, if something should happen that seems to require a visit to the doctor, I would now have to see my primary care doctor for a referral to a specialist, thus netting $60 in co-pays. I'll be handling whatever comes up myself, until I pass out or die. wizard of oz slots online
But isn't that what Republicans/conservatives/evangelicals want anyway? It would be, after all, the most efficient cost-cutting measure if all the expensively and/or chronically sick people would just hurry up and die. Might help with those unemployment, homelessness, and mental health problems too. slots online real money usa
On January 14, I e-mailed Rick Ungar to tell him I appreciate his work and how hard it must be to write like he does for Forbes, as well as to solicit his support for DUH. Much to my delight, he responded almost immediately:
Hi Sue-
Thanks for the note. roulette online real money indonesia
I imagine it won't be too difficult to get me to your Oct event in DC. Sounds like fun!
It actually is not difficult for me to write for a magazine like Forbes. I have never much enjoyed preaching to the converted and find it way more interesting to try and persuade among those who find it difficult to be persuaded. As a result, I tend to gravitate to media opportunities where I might not be expected to show up. This would explain my appearing every Saturday on Fox News!
I hope you'll stay in touch and let me know how your plans are proceeding. Please feel free to call on me if there is anything I can do to help.
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I certainly will stay in touch and I'll look forward to shaking his hand at DUH. Until then, I hope he continues to dare to write and speak sense to those who are so resistant to it. Having had pleasant, civilized conversations with Republicans myself, I know not only the value, but the satisfaction of making headway with the opposition who will have to become allies if single-payer is ever going to be achieved. I might even make myself watch Fox News! us online casino iphonevirtual city casino withdrawal