Pagano back to coach Colts after cancer treatment

 Chuck Pagano stepped to the podium Monday, hugged his team owner, thanked his family for its support and wiped a tear from his eye.
He might, finally, turn out the lights in his office, too.
Nearly three months to the day after being diagnosed with leukemia, the Colts' first-year coach returned to a team eager to reunite with a boss healthy enough to go back to work.
"I told you my best day of my life was July 1, 1989," Pagano said, referring to his wedding date. "Today was No. 2. Getting to pull up, drive in, get out of my car, the key fob still worked. I was beginning to question whether it would or not. When I asked for Bruce to take over, I asked for him to kick some you-know-what and to do great. Damn Bruce, you had to go and win nine games? Tough act to follow. Tough act to follow. Best in the history of the NFL. That's what I have to come back to."
The comment turned tears into the laughter everyone expected on such a festive occasion.
For Pagano and the Colts, Monday morning was as precious as anyone could have imagined when Pagano took an indefinite leave to face the biggest opponent of his life, cancer.
In his absence, all the Colts was win nine of 12 games, make a historic turnaround and clinch a playoff spot all before Sunday's regular-season finale against Houston, which they pegged as the day they hoped to have Pagano back. If all goes well at practice this week, Pagano will be on the sideline for the first time since a Week 3 loss to Jacksonville.
Pagano endured three rounds of chemotherapy to put his cancer in remission.
That Pagano's return came less than 24 hours after Indy (10-5) locked up the No. 5 seed in the AFC and the day before Christmas seemed fitting, too.
"I know Chuck is ready for this challenge. In speaking to his doctor multiple times, I know that the time is right for him to grab the reins, get the head coaching cap on and begin the journey," owner Jim Irsay said. "It's been a miraculous story. It really is a book. It's a fairytale. It's a Hollywood script. It's all those things but it's real."
The reality is that he's returning to a vastly different team than the one he turned over to Arians, his long-time friend and first assistant coaching hire.
Back then, the Colts were 1-2 and most of the so-called experts had written them off as one of the league's worst teams. Now, they're ready to show the football world that they can be just as successful under Pagano as they were under Arians, who tied the NFL record for wins after a midseason coaching change.
Pagano also has changed.
The neatly-trimmed salt-and-pepper hair and trademark goatee that were missing in November have slowly returned, and the thinner man who appeared to be catching his breath during a postgame speech in early November, looked and sounded as good as ever Monday.
He repeatedly thanked fans for their prayers and letters, the organization and his family for their unwavering help and promised to provide comfort and support to other people who are facing similar fights. During one poignant moment that nearly brought out tears again, Pagano even recounted a letter sent to him by a 9-year-old child who suggested he suck on ice chips and strawberry Popsicles in the hospital and advised him to be nice to the nurses regardless of how he felt — and he never even paused.
"I feel great, my weight is back, my energy is back and again, it's just a blessing to be back here," Pagano said.
In the minds of Colts players and coaches, Pagano never really left.
He continually watched practice tape and game film on his computer, used phone calls and text messages to regularly communicate with players and occasionally delivered a pregame or postgame speech to his team.
"He texted me and called me so much, it was like he was standing there in my face every day," said receiver Reggie Wayne, who has been friends with Pagano since the two were working together at the University of Miami.
But the Colts found plenty of other ways to keep Pagano's battle in the forefront.
They began a fundraising campaign for leukemia research, calling it Chuckstrong. Players had stickers with the initials CP on their locker room nameplates, and Arians wore an orange ribbon on his baseball cap during games. Orange is the symbolic color for leukemia. At one point, nearly three dozen players shaved their heads to show their ailing coach they were with him.
That's not all.
Arians and first-year general manager Ryan Grigson decided to leave the lights on in Pagano's office until he returned. Pagano noted the team even installed plastic clips to make sure those lights were not mistakenly turned off while he was gone. Those clips were removed when Pagano arrived Monday morning.
And Arians said nobody sat in the front seat of the team bus.
"He's always been our head coach," Arians said.
So after getting medical clearance from his oncologist, Dr. Larry Cripe, to return with no restrictions, Pagano couldn't wait to get to the office Monday morning.
Arians arrived at 7 a.m., three hours early for the scheduled team meeting. By then, Pagano had already driven past the inflatable Colts player with the words "Welcome Back Chuck" printed on its chest and was back in his office preparing for the Texans.
Players showed up a couple of hours later, and when the torch was passed from Arians back to Pagano, players gave their returning coach a standing ovation that Wayne said was well-deserved.
All Pagano wants to do now is emulate the success Arians and his players have had this season.
"I asked him (Arians) if he would lead this team and this ballclub and this organization and take over the reins," Pagano said. "What a masterful, masterful job you did Bruce. You carried the torch and all you went out and did was win nine ballgames. You got us our 10th win yesterday and you got us into the playoffs. You did it with dignity and you did it with class. You're everything that I always knew you were and more.

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Pagano joins playoff bound Colts after battle with cancer

The Indianapolis Colts and their fans got an early Christmas gift when head coach Chuck Pagano returned to work on Monday, three months after being forced to the sidelines to battle cancer.
Diagnosed with leukemia in late September, Pagano spent the last three months undergoing treatment, including chemotherapy, while his inspired team led by rookie quarterback Andrew Luck battled on the field earning an unlikely playoff spot.
"Circumstances don't make you, they reveal you," an emotional Pagano told reporters after reporting for work at the teams Indianapolis training facility. "The way I look at it is, my job has just begun.
"Besides my job here...my job now is to give back everything I can possibly give back to everyone out there who's fighting some type of illness, some type of disease, some type of cancer."
The Colts, who tied for the NFL's worst record last season at 2-14, improved to 10-5 with their win over the Kansas City Chiefs on Sunday clinching an AFC wild card.
After three games into a rebuilding season, the Colts learned Pagano would take indefinite leave to fight his cancer and was replaced by assistant coach and offensive coordinator Bruce Arians.
The goal of the Colts became to keep playing until Pagano could return to work.
Indianapolis went 9-3 under Arians, who will hand over the head coaching job back to Pagano for the regular season finale this Sunday against the Houston Texans.
"It's a fairy tale," said Colts owner Jim Irsay. "It's a Hollywood script. But it's real.

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Ryan says Tebow would have done wildcat if asked

 Tim Tebow would have done whatever Rex Ryan asked — if the New York Jets coach had asked him.
Ryan acknowledged Monday that Tebow wasn't happy when the coach chose Greg McElroy to start for the benched Mark Sanchez, but insisted Tebow was willing to play in any role Sunday against San Diego — including the wildcat.
"He was disappointed, there's no question," Ryan said Monday. "He was disappointed that he was not named the starter, but with that being said, I'm not going to get into private conversations that I have with players, but it was my decision to use Jeremy Kerley in the wildcat, without question.
"But I'll say this: I believe if Tim's number was called, he would've went in and played. I don't think there's any doubt about that."
A person familiar with the situation told The Associated Press that Tebow asked out of his wildcat offense duties last week after hearing that McElroy, the third-stringer, would get his first NFL start over Tebow, listed as the No. 2 quarterback.
Another person, also familiar with the situation, said that wildcat plays involving Kerley instead of Tebow were added before practice last Wednesday.
Both people spoke on condition of anonymity because the Jets do not disclose personnel discussions.
ESPN New York first reported that Tebow opted out of running wildcat plays. ESPN also reported that Tebow said his relationship with Ryan was "strained" for a few days, but they smoothed things over. Ryan had all three quarterbacks active for Sunday's 27-17 loss, but Tebow never got onto the field in any capacity.
Ryan did not deny that Tebow asked out of running wildcat plays, but also refused to go into any details of what happened.
"I've been transparent and all that stuff without question, but I'm not going to give you a private conversation that I would have with a player," Ryan reiterated. "That's between him and I. If he wants to share whatever the conversation is, Tim or anybody else, then that's up to him."
Ryan was also asked if it could be considered "insubordination" if a player refuses to play in a role designed for him.
"You guys are assuming something's a fact or whatever, and that's fine," Ryan said. "If I would have asked Tim to play in anything, Tim would have gone into the game and done that."
After the game, Tebow would say only that "it just happened" that he didn't play in the wildcat package. He has done his best to hide his frustration throughout what he could consider a lost year on the playing field.
"Well, it's been disappointing," Tebow said of the season. "Obviously, it didn't go as we thought, as I had hoped, but sometimes in life you have that. Sometimes you have setbacks and you just have to look at them as another opportunity for you to step back up and keep working and figure out what to do."
New York will either trade or release Tebow after the season, a disappointing and frustrating one-year stint with the Jets that just seems to get worse. Tebow was asked after the game if he could remember the last time he had played so little.
"Three or 4 years old, probably," Tebow said. "Since I started."
Tebow has not played a single snap in four of the last five games, although some of that inactivity was due to him breaking two ribs at Seattle on Nov. 11. He has been cleared to play, and got a full offensive series at quarterback last Monday night at Tennessee, but Ryan confirmed that Tebow "still has two cracked ribs."
The Jets (6-9) were eliminated last week with their loss to the Titans, and Ryan announced after the game against San Diego that McElroy — despite being sacked 11 times — would start in the season finale at Buffalo. Whether Tebow actually plays in that game or has taken his last snap with the Jets remains to be seen.
Tebow was acquired from Denver in a stunning trade last March and expected to be a major contributor to the offense. He has been only a role player — whenever he actually plays.
"I thought we'd do some better things out of that wildcat," Ryan said. "It hasn't happened. I'm not blaming it on Tim Tebow. I'm sure there's multiple reasons, but for whatever reason, it has not had the results that I envisioned for it."
Some reports have Jacksonville interested in bringing Tebow in to compete for its quarterback job next season. The Jaguars were the only team other than the Jets that tried to trade for Tebow last year, plus it would be a homecoming for Tebow if he played in Jacksonville.
"I'm not pulling the tampering thing," Ryan said. "Tim's under contract with us and that's all I know."
Jaguars coach Mike Mularkey told Jacksonville reporters that he wasn't aware of reports that his team looked into pursuing Tebow before the trade deadline earlier this season.
"I am not going to talk about that," he added. "I don't talk about other players on other teams right now."
NOTES: Ryan was still disgusted by how many times McElroy was sacked by the Chargers on Sunday. "The 11 sacks and all that, that's as poor as I can ever remember as far as the pass protection was concerned," he said. It was the most a Jets QB was sacked since David Norrie in 1987 against Dallas — a game played by replacements. ... The Jets waived WR Mardy Gilyard, who had two catches for 15 yards in three games for New York.

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Column: Seattle isn't just sleepless, it's loud!

That dull roar still rumbling between your ears a day later is not your imagination.
It's the echo from the 49ers-Seahawks game Sunday night, when an already notoriously loud hometown crowd outdid itself. How?
Start with CenturyLink Field, a U-shaped stadium with cantilevered roofs extending over most of the 67,000 seats in the grandstands, a configuration designed to bounce back sound. Then throw in some fans presumably hopped up on espresso and, thanks to a later starting time, some more who stopped at Safeco Field on the way over to quaff 24-oz. beers offered through a promotion at a mere $4.50 each.
Next, mix in their dislike for a nasty NFC West rival and especially coach Jim Harbaugh, who smacked the Washington Huskies every chance he got when he was at Stanford and has been tormenting Seahawks coach Pete Carroll ever since.
Finally, throw in that early, unexpected lead and — voila! — a near-perfect sound storm.
Just know it could have been worse.
"Obviously, they were jacked up last night," said Fred Gaudelli, the innovative producer of "Sunday Night Football" on NBC. "But in my mind, it's one of the underrated sports towns in America. Actually, the special challenge there is always to convey how loud it actually is.
"We knew that going in, plus we knew the 49ers were the team their fans hate the most. So at Wednesday's regular 'brainstorming session,' we turn to our head audio engineer and said, 'How do we make viewers understand you can't hear the person next to you most of the time, even if he's yelling?' We wanted to be ready."
Gaudelli knows what can happen to a team that ventures into Seattle without preparing for the wall of noise.
In 2005, the visiting New York Giants collected 11 false-start penalties in a single game, the start of a five-year span when opponents piled up league-leading totals, averaging twice as many there as the Seahawks. The Carolina Panthers once practiced for a game there by dragging loudspeakers down to the practice field and simulating the sound of a jet engine. If that sounds over the top, it is, by about 18 decibels. Jets are routinely measured at around 130, Century Link's best is only 112.
Gaudelli and his crew hatched a plan to demonstrate that by having sideline reporter Michele Tafoya speak into a microphone as the sound reverberated, then take a step back and try again. When they ran through it before the game, he had a stadium staffer simulate the crowd noise over the PA system. At the point Tafoya's words were drowned out the system was cranked to 50 percent of volume.
"So I asked the guy, is it really going to be that loud? He looked at me," Gaudelli chuckled into the phone, "and said, 'Double it.'"
The guy was right. That much was apparent at the start of the broadcast, when Tafoya interviewed Carroll — remember, the game hadn't even begun — and didn't dare stand anywhere but uncomfortably close.
Uncomfortable might be the right word to describe the 49ers as well, at least in the early going, when they had to burn timeouts as relatively inexperienced quarterback Colin Kaepernick was having trouble getting the play calls from his sideline. Right about then, he probably wished the 49ers had devoted more time to mastering their silent snap counts.
"The crowd's explosive, it really is," Seattle quarterback Russell Wilson said. "They love us so much, and it brings so much energy to our football team. They keep us in the game, obviously, and they keep us alert."
Experts have been arguing over the worth of home-field advantage for decades. Most concluded that in those places where it's statistically significant, it's usually because of a number of factors and not just one, such as noise. Since CenturyLink opened up in 2002, Seattle is 58-29 at home, a 67 percent winning clip that ranks the Seahawks sixth in the NFL over that span. That's a far cry from New England's league-best 72-15 record (83 percent).
But the Seahawks haven't had Tom Brady at quarterback, and their road record is dismal enough (33-55) that the boost the fans at CenturyLink have provided might be best measured by their last four playoff appearances. If that's not exact enough, try this: After a 2001 earthquake shook a viaduct that runs along the water and near the stadium, the University of Washington set up a lab to track future "seismic events." One of them actually occurred during Marshawn Lynch's thundering, winning, 67-yard touchdown run in a memorable upset of the then-defending Super Bowl champion New Orleans Saints on Jan. 9, 2011.
Yet while we know how Seattle fans make so much noise, why remains the subject of much speculation. Gaudelli, like a lot of people, blames coffee. But I'm going with a theory advanced Sunday night by announcer Al Michaels, who suggested the locals roar non-stop because showcase games gives them a rare chance to remind the rest of the country they're there.
"For media people on the East Coast," he said half in jest, "Seattle might as well be Bulgaria.

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Manning, Peterson, Pagano: 2012 a year to remember

From Peyton Manning overcoming four neck surgeries to Adrian Peterson's rebound from a shredded knee to Chuck Pagano's fight with leukemia, this has been the Year of the Comeback in the NFL.
A season besmirched by tragedies, replacement officials and a bounty scandal also will go down as one in which some of the game's greats not only regained their old form but somehow surpassed it.
There are always feel-good stories about those who overcome long odds and broken bodies to regain at least a sliver of their past glory. This season provided an abundance of them.
When the season started, who could have expected Manning to recapture his MVP play so quickly with a new team? Or for Peterson to come back less than nine months after shredding his left knee. Or for Jamaal Charles to return better than ever after suffering a similar injury.
Then there's Pagano beating the biggest opponent of his life.
A year ago, Manning was in the midst of four neck operations to fix a nerve injury that had caused his right arm to atrophy and had sidelined him for an entire season. Soon, he would say a tearful farewell to Indianapolis, a city he'd put back on the NFL map, and hook up with John Elway in Denver.
Peterson's left knee was still swollen after he'd shredded it on Christmas Eve, an injury similar to the one Charles suffered earlier last season. Yet both would defy medicine and conventional wisdom alike to rebound as better runners than they were before getting hurt.
Pagano's fight started three months ago when it was disclosed he had cancer, forcing the first-year Colts coach to take time off for chemotherapy treatments. He returned to work this week, taking the reins from assistant Bruce Arians, who guided the team to a surprising playoff berth in his absence.
"When I asked for Bruce to take over, I asked for him to kick some you-know-what and to do great. Damn Bruce, you had to go and win nine games?" Pagano said. "Tough act to follow."
If all goes well at practice this week, Pagano will be on the sideline for the regular-season finale against Houston. That's a final tuneup for the AFC wild-card playoffs that nobody saw coming for the Colts so soon after cutting ties with Manning, who switched teams, coaches, cities and colors and didn't miss a beat in 2012.
Despite a new supporting cast and a 36-year-old body he insists continues to confound him, the quintessential quarterback has had one of the best seasons in his storied career. Manning set franchise or NFL records just about every week while completing 68 percent of his passes for 4,355 yards with 34 TDs and just 11 interceptions.
And yet, he insists he's not anything close to what he used to be, that all he can do is maximize what's left in a body that's been slowed by so many surgeons' scalpels, and trips around the sun.
"I know you don't believe me when I say this; I'm still learning about myself physically and what I can do, it's still the truth," Manning said after guiding Denver to its 10th straight win. "I still have things that are harder than they used to be, so (there's) things I have to work on from a rehab standpoint and a strength standpoint. That's just the way it is and maybe that's the way it's going to be from here on out, I don't know."
Maybe Manning's being modest, maybe he's suckering opponents into blitzing him more often so he can burn them again. Either way, it's a remarkable rebound for a man whose right arm was so weakened after one of his neck surgeries that he could hardly throw the football 15 yards.
Long before Manning ever dreamed he'd be wearing the orange-mane mustang on his helmet instead of the blue and white horseshoe, Manning met up with college buddy Todd Helton of the Colorado Rockies for a workout during last year's NFL lockout. They retreated to an indoor batting cage at Coors Field with a trainer in tow, and Manning's first pass nose-dived so badly that Helton told him to quit goofing around.
Manning wasn't messing with him. He was dead serious. His arm was shot, his future in football in doubt. A few days later, he underwent spinal fusion surgery and would miss the entire 2011 season.
If doctors had told him that was it, Manning said he would have called it a career without regret. But they gave him a bit of hope and that's all he needed to embark on his comeback in Colorado.
Coach John Fox, never one to lobby for awards, suggested this week that Manning deserves a fifth MVP honor for the numbers he's put up, the obstacles he's overcome, the shift of culture he's engineered.
Manning isn't interested in talking about MVPs or comeback awards. He just wants enough wins to get a shot at hoisting another Lombardi Trophy in New Orleans in six weeks.
Peterson, on the other hand, is unabashedly clear in his desire for some recognition after overcoming torn anterior cruciate and medial collateral ligaments in his left knee, requiring the kind of reconstructive surgery that usually turns dominant players into ordinary ones.
There's a long, long list of players who had shortened careers because of such injuries. But Peterson returned to the Vikings lineup less than nine months after his operation, and with a league-high 1,898 yards, he's 207 yards shy of Eric Dickerson's single-season record. He can topple it with another big game Sunday when Minnesota faces Green Bay with a playoff berth on the line for the Vikings.
With typical unflinching confidence, Peterson said in a recent interview with The Associated Press he's expecting to win the comeback award.
"I kind of have that in the bag, especially how I've been telling people I'm going to come back stronger and better than ever," he said.
Carrying the Vikings to the playoffs without a potent passing game in a league dominated by strong-armed, accurate quarterbacks would only burnish the credentials of this thoroughbred throwback.
In any other year, the zenith of comebacks might be that of Carolina linebacker Thomas Davis, who battled back from three torn right ACLs — in 2009, 2010 and 2011 — to be a major contributor to the Panthers this year. No player in NFL history has returned after tearing the same ACL three separate times.
Charles missed nearly all of 2011 with a torn left ACL. Yet the former All-Pro running back has run for 1,456 yards, the seventh-best season in franchise history. He can break his single-season-high set in 2010 with 12 yards against the Broncos on Sunday.
Charles ran for 226 yards last weekend, when he surpassed 750 career carries, which also qualifies him for the NFL record for yards per carry. Charles is averaging 5.82 yards on 770 attempts, which far surpasses the 5.22 yards that Hall of Famer Jim Brown averaged in 2,359 attempts from 1957-65.
Charles, Peterson and Davis are all better than ever. Manning might be, too, but he'll never say it.
"I'm trying to be as good as I can at this stage," Manning said. "A 36-year-old quarterback coming off a year and a-half off, playing on a new team, I'm trying to be as good as I possibly can in this scenario.
"It's a different kind of body I'm playing in and just a different kind of quarterback play for me."
Yet, as transcendent as ever.
"If he's lost anything, I can't see it," said Broncos receiver Brandon Stokley, who played with Manning in his prime in Indianapolis. "I'm sure in some ways he's better than he ever was. And he's always been great.

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Hepatitis C tests continue after NH tech's arrest

Hospitals across the country recommended hepatitis C testing for about 7,900 patients last summer after a traveling medical worker was accused of stealing drugs and infecting patients with tainted syringes in New Hampshire. But five months later, nearly half of those who were possibly exposed to the liver-destroying disease in other states have yet to be tested. Described by prosecutors as a "serial infector," David Kwiatkowski is accused of stealing syringes of the powerful painkiller fentanyl from the cardiac catheterization lab at New Hampshire's Exeter Hospital and replacing them with saline-filled syringes tainted with his own blood. In jail since his arrest in July, he pleaded not guilty to 14 federal drug charges earlier this month and is expected to go to trial next fall. Before April 2001, when he was hired in New Hampshire, Kwiatkowski worked as a traveling cardiac technologist in 18 hospitals in seven states, moving from job to job — despite being fired twice over allegations of drug use and theft. Thirty-two people in New Hampshire have been diagnosed with the same strain of hepatitis C that Kwiatkowski carries, along with six in Kansas, five in Maryland and one in Pennsylvania. At least 3,700 people outside New Hampshire have yet to be tested, hospitals and public health officials told The Associated Press. For example, in Michigan, where Kwiatkowski grew up and started his career, about 2,300 patients at five hospitals were notified that they may have been exposed to hepatitis C by Kwiatkowski. As of early December, only about 500 had gone in for testing, none of whom were diagnosed with a strain linked to the New Hampshire outbreak, according to the Michigan Department of Community Health. In Pennsylvania, 2,280 patients at the University of Pittsburgh Medical Center Presbyterian were notified that they should get tested, but only 840 have, one of whom was diagnosed with a matching strain of hepatitis C. Kwiatkowski was fired a few weeks into his temporary job at UPMC in 2008 after a co-worker accused him of swiping a fentanyl syringe from an operating room and sticking it down his pants. Citing a lack of evidence, hospital authorities didn't call police, and neither the hospital nor the medical staffing agency that placed him in the job informed the national accreditation organization for radiological technicians. Within days, Kwiatkowski was starting a new job at the Baltimore VA Medical Center, where one patient also has since been diagnosed with hepatitis C linked to Kwiatkowski. Though the VA center initially said it had identified 168 patients who may have been exposed, that number was later lowered, and 68 patients ultimately were tested. Two other Maryland hospitals where Kwiatkowski worked also have completed their testing, with no diagnosed cases of hepatitis C matching Kwiatkowski. But at the fourth, The Johns Hopkins Hospital in Baltimore, four patients have been diagnosed with the strain of disease linked to Kwiatkowski. About 500 of the 1,567 patients notified by Johns Hopkins have yet to be tested, according to hospital spokeswoman Kim Hoppe. Kwiatkowski had been referred by a staffing agency that assured Johns Hopkins that it had followed a vigorous vetting process, Hoppe said. He worked there for two 13-week stints, from July 2009 to January 2010. Saint Francis Hospital in Poughkeepsie, N.Y., where Kwiatkowski worked in late 2007 and early 2008, notified and tested 31 patients without finding any linked cases to Kwiatkowski. In Kansas, nearly all of the 416 patients who may have been exposed at Hays Medical Center have been tested and six have been diagnosed with infections linked to the New Hampshire outbreak. There have been no cases linked to Kwiatkowski in Arizona, where about 300 patients from two hospitals have been asked to get tested and about 280 have done so. Kwiatkowski worked at Maryvale Hospital in Phoenix in 2009 and the Arizona Heart Hospital in 2010. He was fired from the latter job after 10 days after a co-worker found him passed out in a bathroom stall with a stolen fentanyl syringe floating in the toilet. That incident was reported to police, Kwiatkowski's staffing agency, a state regulatory board and the national accreditation organization, but the accreditation group dropped its inquiry after learning police hadn't filed charges. Days later, Kwiatkowski landed a new job filling in for striking technicians at Temple University Hospital in Philadelphia. That hospital has recommended testing for 312 patients but won't say how many have followed through or have been diagnosed with hepatitis C. A hospital spokesman referred questions to the city health department, which did not return calls. Testing also is still under way in the last place Kwiatkowski worked before heading to New Hampshire — Houston Medical Center in Warner Robins, Ga. According to the hospital, fewer than 100 people have yet to be tested, and there haven't been any cases yet linked to Kwiatkowski. In New Hampshire, where about 3,300 patients were tested, Kwiatkowski is charged with seven counts of illegally obtaining drugs and seven counts of tampering with a consumer product, though prosecutors have said further charges are possible. Although New Hampshire cannot charge him for possible violations in other states, it can use evidence gathered in those jurisdictions in its trial, U.S. Attorney John Kacavas said. Other states are waiting to see the outcome of New Hampshire's case before deciding whether to file charges, he said. "We continue to reach out to other states affected by this matter," Kacavas said this week. "Other health organizations and departments continue to do their work in their states, but nothing has changed in the sense that our prosecution will go forward. At this point, we are the only prosecution in the country, and we'll see how it rolls out.

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Analysis: Stop-gap fix most likely outcome of "fiscal cliff" talks

The "fiscal cliff" deadline is days away and the U.S. Congress and President Barack Obama have left town for Christmas. But even if they were still here, it wouldn't have mattered, according to Steny Hoyer, the second-ranking Democrat in the House of Representatives. He says they were going nowhere to resolving the disagreement over how to fix the nation's fiscal problems. Last month's dreams of a "grand bargain" of tax hikes and spending cuts seem long gone. They had been reduced to more modest bargains in mid-December, and as 2013 approaches, are on the verge of relegation to a "stop-gap measure," at best the sort of temporary fix that Congress undertook in 2011. A stop-gap that puts everything off for a while but resolves nothing is now the most promising alternative, if there is to be one, to the across-the-board tax hikes and spending cuts described as a "fiscal cliff" because they threaten to send the U.S. economy plunging into another recession. It is also the way fiscal showdowns have ended in Washington in recent years. Such a fix, at best, would delay the spending cuts and tax hikes further into 2013 as well as work to address in a long-term way a government budget that has generated deficits exceeding $1 trillion in each of the last four years. Even worse, it would set up a huge fight in January and February over raising the U.S. debt ceiling, which controls the amount of money the federal government can borrow. Dysfunction in Washington was specifically cited as one of the reasons rating agency Standard & Poor's cut the U.S. debt rating to AA-plus after a battle over the debt ceiling in 2011. That alone - not to mention going over the cliff - could lead to another rating cut. At worst, the new year could start with a full-fledged jump off the 'cliff,' with an understanding, communicated to financial markets, that Congress and the White House would come back and try again for a solution. Given the apparent deadlock, some congressional aides this week said that Washington needed to begin telegraphing to Wall Street that markets should not panic if a "fiscal cliff" deal is not struck in December. The goal, one aide said on condition of anonymity, is to avoid starting 2013 with a steep stock market drop like the one the U.S. suffered in 2008, when the country's financial industry was falling apart and Congress was divided over what to do. On Friday, Obama acknowledged that only small steps might be possible with so little time remaining. Those, the Democratic president said, would consist of extending benefits for the long-term unemployed and keeping income tax rates low for 98 percent of Americans - meaning raising taxes on households with net incomes above $250,000 a year but not for those earning less. He held out the possibility of something "comprehensive," as he put it, but it had a hollow ring at the close of a work week that saw House Speaker John Boehner step back from negotiations and pursue a partisan plan that even some of his fellow Republicans could not stomach. MARKET PRESSURE The steps that Obama outlined were immediately rejected by Republicans, who have given ground on their previous steadfast opposition to any tax hikes but are still demanding that the White House agree to more substantial spending cuts. "The president has failed to offer any solution that passes the test of balance," declared Boehner spokesman Brendan Buck, minutes after the end of Obama's statement on Friday. On Saturday, a spokesman for Senate Republican leader Mitch McConnell was similarly dismissive, noting Obama's call had neither bipartisan support nor spending cuts to ride along with tax increases. McConnell, on Friday, suggested bringing up a House-passed bill that extends current tax rates for all Americans, including the top earners, and then pushes for comprehensive tax reform next year that theoretically could raise new revenues to help cut deficits. But Obama has promised repeatedly to veto any extension of the expiring Bush-era tax cuts that fail to hike rates for the wealthy. And Democrats, who control the Senate, have dismissed the McConnell idea, arguing that Obama ran his successful 2012 re-election campaign on a promise of forcing the wealthy to bear more of the burden of deficit reduction. Democratic aides in Congress think their own bill implementing Obama's $250,000 income threshold, which passed the 100-member Senate in July with 51 votes, could breeze through this month, or next year after the "fiscal cliff" is breached. The prospect of a breach is being discussed far more seriously now, and not just as a bluff or to set up the other side for blame. "I think we're going to go over the cliff," said Republican Representative Patrick Tiberi of Ohio. "I don't see something getting done." In an MSNBC interview Friday, Hoyer, a 31-year veteran of Congress from Maryland, said it wouldn't matter if everyone was in Washington instead of on holiday. "Frankly, we've been in town for four weeks and members haven`t been doing much," he said, calling it "one of the least productive times that I've been in Congress." Even Obama speaks of "a mismatch" between how people are thinking about the looming tax hikes and spending cuts "outside of this town and how folks are operating here. And we've just got to get that aligned," he said in his statement. ITG Investment Research Chief Economist Steve Blitz on Saturday said sliding the "fiscal cliff" negotiations into the new year was not a huge deal. "I think markets will pressure for a deal in January," he said. The "pressure" could be in the form of a significant stock market drop, which would hit workers' retirement plans, threaten to deter consumer and business spending, and possibly rattle other countries' economies at a time when the global economy is far from robust.

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Violence, fear & suspicion imperil Pakistan's war on polio

Pakistani health worker Bushra Bibi spent eight years trekking to remote villages, carefully dripping polio vaccine into toddlers' pursed mouths to protect them from the crippling disease. Now the 35-year-old mother is too scared to go to work after masked men on motorbikes gunned down nine of her fellow health workers in a string of attacks this week. "I have seen so much pain in the eyes of mothers whose children have been infected. So I have never seen this as just a job. It is my passion," she said. "But I also have a family to look after ... Things have never been this bad." After the deaths, the United Nations put its workers on lockdown. Immunizations by the Pakistani government continued in parts of the country. But the violence raised fresh questions over stability in the South Asian nation. Pakistan's Taliban insurgency, convinced that the anti-polio drive is just another Western plot against Muslims, has long threatened action against anyone taking part in it. The militant group's hostility deepened after it emerged that the CIA - with the help of a Pakistani doctor - had used a vaccination campaign to spy on Osama bin Laden's compound before he was killed by U.S. special forces in a Pakistan town last year. Critics say the attacks on the health workers are a prime example of the government's failure to formulate a decisive policy on tackling militancy, despite pressure from key ally the United States, the source of billions of dollars in aid. For years, authorities were aware that Taliban commanders had broadcast claims that the vaccination drive was actually a plot to sterilize Muslims. That may seem absurd to the West, but in Pakistan such assertions are plausible to some. Years of secrecy during military dictatorships, frequent political upheaval during civilian rule and a poor public education system mean conspiracy theories run wild. "Ever since they began to give these polio drops, children are reaching maturity a lot earlier, especially girls. Now 12 to 13-year-old girls are becoming women. This causes indecency in society," said 45-year-old Mir Alam Khan, a carpet seller in the northern town of Dera Ismail Khan. The father of four didn't allow any of his children to receive vaccinations. "Why doesn't the United States give free cures for other illnesses? Why only polio? There has to be an agenda," he said. While health workers risk attacks by militants, growing suspicions from ordinary Pakistanis are lowering their morale. Fatima, a health worker in the northwestern city of Peshawar, said that reaction to news of the CIA polio campaign was so severe that many of her colleagues quit. "People's attitudes have changed. You will not believe how even the most educated and well-to-do people will turn us away, calling us U.S. spies and un-Islamic," said the 25-year-old who did not give her last name for fear of reprisals. "Boys call us names, they say we are 'indecent women'." Pakistan's government has tried to shatter the myths that can undermine even the best-intentioned health projects by turning to moderate clerics and urging them to issue religious rulings supporting the anti-polio efforts. Tahir Ashrafi, head of the All Pakistan Ulema Council, said the alliance of clerics had done its part, and it was up to the government to come to the rescue of aid workers. "Clerics can only give fatwas and will continue to come together and condemn such acts," he said. "What good are fatwas if the government doesn't provide security?" RISK OF POLIO RETURNING That may be a tall order in Pakistan, where critics allege government officials are too busy lining their pockets or locked in power struggles to protect its citizens, even children vulnerable to diseases that can cripple or disfigure them. Pakistani leaders deny such accusations. Politicians also have a questionable track record when it comes to dealing with all the other troubles afflicting nuclear-armed Pakistan. The villages where health workers once spent time tending to children often lack basic services, clinics, clean water and jobs. Industries that could strengthen the fragile economy are hobbled by chronic power cuts. Deepening frustrations with those issues often encourage Pakistanis to give up on the state and join the Taliban. So far it's unclear who is behind the shootings. The main Taliban spokesman said they were opposed to the vaccination scheme but the group distanced itself from the attacks. But another Taliban spokesman in South Waziristan said their fighters were behind an attack on a polio team in the northwestern town of Lakki Marwat on Monday. "The vaccinations were part of "a secret Jewish-American agenda to poison Pakistanis", he said. What is clear is the stakes are high. Any gaps in the program endanger hard-won gains against a disease that can cause death or paralysis within hours. A global effort costing billions of dollars eradicated polio from every country except Nigeria, Afghanistan and Pakistan. Vaccinations cut Pakistan's polio cases from 20,000 in 1994 to 56 in 2012 and the disease seemed isolated in a pocket in the north. But polio is spread person-to-person, so any outbreak risks re-infecting communities cleared of the disease. Last year, a strain from Pakistan spread northeast and caused the first outbreak in neighboring China since 1999. Oliver Rosenbauer, a spokesman for the World Health Organization, said the group had been coming closer to eradicating the disease. "For the first time, the virus had been geographically cornered," he said. "We don't want to lose the gains that had been made ... Any suspension of activities gives the virus a new foothold and the potential to come roaring back and paralyze more children." MOURNING FAMILIES Condemnation of the killings has been nearly universal. Clerics called for demonstrations to support health workers, the government has promised compensation for the deaths and police have vowed to provide more protection. For women like Fehmida Shah, it's already too late. The 44-year-old health worker lived with her family in a two-room house before gunmen shot her on Tuesday. Her husband, Syed Riaz Shah, said she spent her tiny salary - the equivalent of just $2 a day - on presents for their four daughters. Even though the family was struggling, she always found some spare money for any neighbor in need. "She was very kind and big hearted. All the women in our lane knew her," he said. "The entire neighborhood is in shock. Pray for my daughters. I will get through this. But I don't know how they will.

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Meanwhile, Deep Inside Your Belly Button …

Researchers have found that more than 2,000 different species of bacteria live in our umbilicus – the medical word for belly button. That means you have more kinds of bacteria in your belly button than there are different kinds of ants or birds in North America, according to the study. The majority of these bacteria were rare and occurred in just one individual. No single type was common to all 60 belly buttons sampled. “I don’t find it alarming,” said Dr. William Schaffner, an expert in infectious diseases at Vanderbilt University Medical Center in Nashville, Tenn. “We knew belly buttons weren’t sterile.” However, Schaffner believes that this does not minimize the study’s findings. “This is in the context of a much larger study, which is trying to … get greater insight into the source of pathogens and how the [bacteria on our body] changes with antimicrobial therapy and age.” Perhaps, he said, we can “use this to develop new antimicrobials.” The benefits may extend beyond antibiotics. “Understanding the biodiversity of our bodies and how it differs among people may play an important role in understanding why some … people are susceptible to the same pathogen or respond to the same drug or diet,” said Dr. Rob Knight, associate professor of molecular biophysics at the University of Colorado – Boulder. Although the findings of the study do not have any immediate implications, this is good timing for a public service announcement from Dr. Gregory Poland, infectious disease expert at the Mayo Clinic in Rochester, Minn. “The current fad of women piercing their umbilicus has led to many case reports of infections,” Poland said. “And with today’s multiple drug-resistant bacteria, it can lead to disasters.

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Cancer Immunotherapy Where Are We Going?

The compelling concept of utilizing the patient's own immune system for a stronger and more effective way to attack cancer cells is not a new one. William Coley observed in 1891 that infections produced in patients with inoperable cancer following an injection of streptococcal organisms (Gram-positive bacteria) led to tumor shrinkage especially when the patients developed fever and other signs of a full-blown infection.1 Since then, research has embraced approaches to "train" the patient's own immune system to recognize certain biomarkers or proteins that are mainly found on cancer cells and to destroy the cells. After several setbacks the first cellular immunotherapy, Dendreon's Sipuleucel-T (Provenge(R)), was approved for the treatment of prostate cancer in 2010. Today, new promising cancer immunotherapy approaches are in clinical trials. Most recently, researchers at the 54th American Society of Hematology (ASH) meeting reported early success with a developmental-stage cell-based cancer vaccine for the treatment of leukemia and have shown remission in several patients 2,3, including a 7-year old girl who relapsed twice after chemotherapy. Cancer immunotherapy can be thought of as either active or passive immunotherapy. The most prominent passive immunotherapies, which have revolutionized cancer therapy, are monoclonal antibodies that either target tumor-specific antigens and receptors or block important pathways central to tumor growth and survival. Therapeutic monoclonal antibodies are the market leader in the targeted cancer therapy space and include blockbusters such as trastuzumab (Herceptin(R)) or rituximab (Rituxan(R)). In general, antibodies are significant elements of the body's adaptive immune system. They play a dominant role in the recognition of foreign antigens and the stimulation of the immune response. Therapeutic antibodies target and bind to antigens, usually proteins that are mainly expressed on diseased cells such as cancer cells. After binding, cancer cells can be destroyed by different mechanisms such as antibody-dependent cellular cytotoxicity, the activation of the complement system -- an important part of the immune system -- and triggering cell death. Although very successful, especially in oncology, therapeutic antibodies have a significant limitation: they don't generate a memory response by the immune system, and thus, repeated antibody infusions are required. Further, monoclonal antibodies are only able to recognize specific proteins present of the cell surface. Monoclonal antibodies are mostly produced in cell culture systems which are often costly. Humanization of murine monoclonal antibodies by replacing of certain parts of the antibody with human sequences has improved the tolerability of antibodies and made them less immunogenic, but even fully human sequence-derived antibodies can carry some immunological risk. Novel approaches in the passive immunization strategy include antibody drug conjugates, a combination of targeting antibody with a very potent drug such as the recently approved brentuximab vedotin (ADCETRIS(TM)) for Hodgkin lymphoma and anaplastic large cell lymphoma (ALCL). ADCETRIS comprises an anti-CD30 monoclonal antibodyanti-CD30 monoclonal antibody and a cytotoxic (cell-killing) agent that is released upon internalization into CD30-expressing tumor cells. Currently, the development of next generations of ADCs is underway. Alternatively, specific and durable cancer immunotherapies designed to actively "train" or stimulate the patient's intrinsic immune response have been more problematic; however, recent success stories, such as the cell-based immunotherapy Provenge, have revitalized this field. Dendreon's approach modifies the patients' own dendritic cells to present a protein specific to prostate cancer cells. Dendritic cells are the most potent, "professional" antigen-presenting cells. They process the antigen material and present it on their surface to other cells of the immune system. Once activated, the dendritic cells migrate to the lymphoid tissues where they interact with T-cells and B-cells -- white blood cells and important components of the immune system -- to initiate and shape the adaptive immune response. To develop Provenge, each patient's own dendritic cells are harvested and then loaded ex vivo with the tumor-associated antigen. Now "presenting" the antigen, the dendritic cells are administered back into the patient to induce a potent, cell-mediated anticancer immune response resulting in tumor shrinkage and clinical benefit. In another experimental approach for the treatment of leukemia, patients' own modified T-cells were infused back into the patients. Prior to this, the T-cells were transduced with a lentivirus to express the CD19-specific chimeric antigen receptor. CD19 is an antigen which is found on B-cell neoplasms, cancerous B-cells, and the lentivirus was the vehicle to transfer the genetic material for CD19 into the cells. A case report published in the New England Journal of Medicine stated that a patient with chronic lymphocytic leukemia (CLL) was in ongoing remission 10 months after treatment.3 These promising results have spurred continued research for new and safe ways to achieve effective tumor vaccination, and drug developers have explored many cancer immunotherapy strategies. To generate an effective antitumor immunity, therapeutic intervention should drive several functions; specifically, it should promote the antigen presentation functions of dendritic cells, promote the production of protective T-cell responses, stimulate B-cells and overcome immunosuppression characteristics that are common to tumor cells.4 Cell-based therapeutic vaccines are most frequently produced outside the patient's body and involve isolation of the specific cells, such as dendritic cells, and the introduction of preselected antigens, often with the use of specific vehicle, into the cells. The antigens can be encoded in viral vectors (frequently DNA) or administered as peptides or proteins in a suitable adjuvant and carrier through a long and cumbersome process. During my doctoral thesis, I conducted immunization experiments using RNA as a negative control, assuming that the RNA would be degraded during the experiment thus making it impossible to use as a vaccine. The physiological role of messenger (m) RNA is to transfer genetic information from the nucleus to the cytoplasm where this information is translated into the corresponding protein. mRNA is known to be very unstable and has a relatively short half-life. But astonishingly, we were able to measure a solid T-cell immune response. We repeated the experiment and confirmed that the RNA we had produced had the potential to be used as a vaccine. Importantly, we didn't need to isolate the patients' cells: mRNA-based vaccines can be injected directly into the skin (intradermal). The mRNA-based vaccines are then taken up by antigen-presenting cells, such as dendritic cells, and are then able to induce an immune response. Importantly, mRNA-vaccines can also be synthesized quickly for any antigen sequence identified.5 The first mRNA-based vaccines (RNActive(R)) are now in the clinic for the treatment of prostate cancer and lung cancer and have demonstrated that they do what they are supposed to do - induce a balanced humoral, as well as T cell-mediated, immune response that is entirely HLA independent. The HLA (human leukocyte antigen) system is used to differentiate the body's own cells (self) and non-self cells. Additionally, RNA-vaccines do not need a vehicle such as a virus for delivery to the cells, nor do they contain virus-derived elements that are often found in DNA-vaccines. These attributes make RNActive a very safe therapeutic. The risk of integration of the RNA into the host-genome is minimized (RNA would have been transcribed first to DNA, and then it has to be transported to the nucleus), as is the residual risk of DNA-based vaccines for inactivating or activating genes or affecting cellular regulatory elements, which can induce oncogenesis. Thus, the favorable safety profile of mRNA-based therapies broadens their potential use not only for the treatment of diseases but for use as prophylactic vaccinations. A recent proof-of-concept study using mRNA-based vaccines (RNActive) in animal models for influenza was published in Nature Biotechnology.6 Therapeutic cancer immunotherapies and vaccines have come a long way, and novel, promising approaches give hope for safe and effective treatment options. This may one day lead to the treatment of all cancers as chronic diseases. Literature 1Kirkwood JM, Butterfield LH, Tarhini AA, Zarour H, Kalinski P, Ferrone S: Immunotherapy of cancer in 2012. CA Cancer J Clin. 2012 2June CH, Blazar BR: T-Cell Infusions: A New Tool for Transfusion Medicine That Has Come of Age. Presentation at 54th ASH Annual Meeting 2013 3Porter DL, Levine BL, Kalos M, Bagg A, and June CH: Chimeric Antigen Receptor-Modified T Cells in Chronic Lymphoid Leukemia. N Engl J Med 2011 4Mellman I, Coukos G, Dranoff G: Cancer immunotherapy comes of age. Nature. 2011 Petsch B, Schnee M, Vogel AB, Lange E, Hoffmann B, Voss D, Schlake T, Thess A, Kallen KJ, 5Hoerr I, Obst R, Rammensee HG, Jung G: In vivo application of RNA leads to induction of specific cytotoxic T lymphocytes and antibodies. Eur J Immunol. 2000 6Petsch B, Schnee M, Vogel AB, Lange E, Hoffmann B, Voss D, Schlake T, Thess A, Kallen KJ, Stitz L, Kramps T: Protective efficacy of in vitro synthesized, specific mRNA vaccines against influenza A virus infection. Nat Biotechnol. 2012

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