Study Bolsters Link Between Routine Hits to Head and Long-Term Brain Disease





The growing evidence of a link between head trauma and long-term, degenerative brain disease was amplified in an extensive study of athletes, military veterans and others who absorbed repeated hits to the head, according to new findings published in the scientific journal Brain.




The study, which included brain samples taken posthumously from 85 people who had histories of repeated mild traumatic brain injury, added to the mounting body of research revealing the possible consequences of routine hits to the head in sports like football and hockey. The possibility that such mild head trauma could result in long-term cognitive impairment has come to vex sports officials, team doctors, athletes and parents in recent years.


Of the group of 85 people, 80 percent (68 men) — nearly all of whom played sports — showed evidence of chronic traumatic encephalopathy, or C.T.E., a degenerative and incurable disease whose symptoms can include memory loss, depression and dementia.


Among the group found to have C.T.E., 50 were football players, including 33 who played in the N.F.L. Among them were stars like Dave Duerson, Cookie Gilchrist and John Mackey. Many of the players were linemen and running backs, positions that tend to have more contact with opponents.


Six high school football players, nine college football players, seven pro boxers and four N.H.L. players, including Derek Boogaard, the former hockey enforcer who died from an accidental overdose of alcohol and painkillers, also showed signs of C.T.E. The study also included 21 veterans, most of whom were also athletes, who showed signs of C.T.E.


The study was conducted by investigators at the Boston University Center for the Study of Traumatic Encephalopathy and the Veterans Affairs Boston Healthcare System, in collaboration with the Sports Legacy Institute. It took four years to complete, included subjects 17 to 98 years old, and more than doubled the number of documented cases of C.T.E. The investigators also created a four-tiered system to classify degrees of C.T.E., hoping it would help doctors treat patients.


The volume of cases in the study “allows us to see the disease at all stages of severity and how it starts and spreads in the brain, which gives us an idea of the mechanism of the injury,” said Ann McKee, the main author of the study, who is a professor of neurology and pathology at Boston University School of Medicine and works at the V.A. Boston.


Those categorized as having Stage 1 of the disease had headaches and loss of attention and concentration, while those with Stage 2 also had depression, explosive behavior and short-term memory loss. Those with Stage 3 of C.T.E., including Duerson, a former All-Pro defensive back for the Chicago Bears who killed himself last year, had cognitive impairment and trouble with executive functions like planning and organizing. Those with Stage 4 had dementia, difficulty finding words and aggression.


Despite the breadth of the findings, the study, like others before it, did not prove definitively that head injuries sustained on the field caused C.T.E. To do that, doctors would need to identify the disease in living patients by using imaging equipment, blood tests or other techniques. Researchers have not been able to determine why some athletes who performed in the same conditions did not develop C.T.E.


The study also did not demonstrate what percentage of professional football players were likely to develop C.T.E. To do that, investigators would need to study the brains of players who do not develop C.T.E., and those are difficult to acquire because families of former players who do not exhibit symptoms are less likely to donate their brains to science.


“It’s a gambler’s game to try to predict what percentage of the population has this,” said Chris Nowinski, a co-author of the study and a co-director of the Center for the Study of Traumatic Encephalopathy at Boston University School of Medicine. “Many of the families donated the brains of their loved ones because they were symptomatic. Still, this is probably more widespread than we think.”


Researchers expected the details in the study to dispel doubts about the likelihood that many years of head trauma can lead to C.T.E. The growing connections between head trauma and contact sports, though, have led some nervous parents and coaches to assume that any concussion could lead to long-term impairment. Some doctors say that oversimplifies matters. Rather, the total amount of head trauma, including smaller subconcussive hits, as well as how they were treated, must be considered when evaluating whether an athlete is more at risk of developing a disease like C.T.E.


“All concussions are not created equal,” said Robert Cantu, a co-author of the study and a co-director of the encephalopathy center. “Parents have become paranoid about concussions and connecting the dots with C.T.E., and that’s wrong. The dots are really about total head trauma.”


Read More..

A Mets Owner and Claims of Consumer Fraud





This article is by Steve Eder, Richard Sandomir and Alison Leigh Cowan.




In March 2012, a group of online retailers was sued in federal court, accused of having participated in a cynical and longstanding scheme to cheat customers out of millions of dollars. One of the named defendants is 1-800-Flowers.com Inc., which says it is the world’s leading florist and gift shop.


The plaintiffs said the system worked this way: a customer, perhaps racing to buy flowers online for Mother’s Day, would enter a credit card number, click “Purchase,” and then be offered a cash-back rebate. If the customer clicked on the rebate option and failed to read the fine print, however, he or she wound up registering for a near-worthless club membership that would charge the credit card for months, sometimes years, before the expenses on the credit card statements were detected. Outfits like 1-800-Flowers.com received a cut of the operation, what regulators and others have called “bounties.”


A recent legal filing by lawyers in the case asserted that “1-800-Flowers was well aware that its customers were getting defrauded.”


Shortly after the lawsuit was filed in Connecticut last spring, the founder and chief executive of 1-800-Flowers.com officially became a minority owner of the Mets. The company executive, James F. McCann, had been selected by the team’s owners as one of a handful of investors whose infusion of cash was needed to help rescue the Mets from a financial crisis.


The team’s owners, Fred Wilpon and Saul Katz, have never told the public, or fans, the identity of the emergency investors — and new part owners. But McCann, whose company has long been an official sponsor of the Mets, and whose advertisements are prominently displayed at Citi Field, has acknowledged that he now owns a small chunk of the team.


It is unclear if Wilpon and Katz knew that McCann’s company had been accused of defrauding customers.


But a review of 1-800-Flowers.com’s legal problems makes clear that the 2012 lawsuit is hardly the first time someone has accused McCann’s business of knowingly participating in defrauding customers — with some of its victims quite possibly Mets fans, given the company’s aggressive marketing to the team’s loyal supporters.


Two years ago, a lawsuit was filed in federal court in Long Island claiming consumer fraud and racketeering violations against 1-800-Flowers.com and other companies, alleging they had worked together to “levy unauthorized charges on the unsuspecting consumers’ credit or debit card accounts” by inducing customers to pay for memberships to discount clubs without their knowledge.


That lawsuit, now in the process of being consolidated with the Connecticut case, came after the New York attorney general at the time, Andrew M. Cuomo, launched an investigation into the “discount club” industry, finding that 1-800-Flowers.com and other companies had “tricked” consumers into signing up for these memberships that charged them hidden fees.


There were also Senate investigative reports, issued in November 2009 and May 2010, that prominently cited 1-800-Flowers.com for its aggressive online sales tactics, saying the Long Island-based flower firm had been paid more than $10 million for allowing others to engage in what the report described as “post-transaction marketing.”


A spokesman for McCann and 1-800-Flowers.com would not comment for this article but said in an e-mail that the matters raised “are more than two years old, have been largely resolved and have been previously disclosed in our company’s public filings.” Last month, 1-800-Flowers.com Inc. said in a regulatory filing that it intended to defend itself vigorously in each of the outstanding lawsuits.


But in a 2010 settlement with the New York attorney general, the company paid $325,000 and promised to end practices Cuomo’s office had called “fraudulent,” at least as they related to the company’s New York customers. The company neither admitted nor disputed claims of wrongdoing as part of the settlement.


The settlement noted that 1-800-Flowers.com had since removed the solicitation and membership club enrollment link from its order confirmation page.


A spokesman for Wilpon and Katz and the Mets declined to comment on McCann’s legal entanglements.


In 2008, when Bernard L. Madoff was arrested and his multibillion-dollar Ponzi scheme collapsed, Wilpon and Katz, as longtime Madoff clients with investments of hundreds of millions of dollars, had their financial empire upended. Things got worse when, late in 2010, the court-appointed trustee representing Madoff’s victims sued Wilpon and Katz for $1 billion, saying they had enriched themselves for years while ignoring warnings that Madoff was up to no good.


Wilpon and Katz, as a consequence, went in search of cash. The men needed to repay some of their debt and deal with operating losses that rose to $70 million in 2011. The men ultimately decided to raise $200 million by selling 10 to 12 shares in the club, each representing a 4 percent ownership stake. Eventually, 12 were sold, but only a small number went to true outsiders.


One of those outsiders is Steven A. Cohen, the head of SAC Capital Advisors, a $14 billion hedge fund at the focus of an intensifying government investigation into insider trading. Cohen has not been accused of wrongdoing and may never be, but last month federal prosecutors charged a former portfolio manager with a $276 million insider trading scheme that for the first time connected Cohen to some questionable trades. Prosecutors have called the most recent case against an associate of Cohen’s the most lucrative insider trading case in history.


McCann, while technically an outside investor, is an old friend of Wilpon’s. McCann has long been part of a group that every season visits spring training at Port St. Lucie, Fla.


Read More..

Egyptian Court Postpones Ruling on Charter


Wissam Nassar


Egyptian police officers stood guard outside Egypt's Supreme Constitutional Court on Sunday, while supporters of President Mohamed Morsi protested near the entrance of the building.







CAIRO — Egypt’s highest court on Sunday postponed its much-awaited ruling on the legitimacy of the legislative assembly that drafted a new charter last week, accusing a crowd of Islamists of blocking judges from entering their building on what it called “a dark black day in the history of the Egyptian judiciary.”




Although hundreds of security officers were on hand to ensure that judges of the Supreme Constitutional Court could get into the court, and civilians came and went without any problems, the accusations intensified a standoff between the judges appointed under former President Hosni Mubarak and Egypt’s new Islamist leaders that has thrown the political transition into a new crisis 22 months after Mr. Mubarak’s ouster.


Upon approaching the court on Sunday morning, the judges said in a statement that they saw crowds “closing the entrances of the roads to the gates, climbing the fences, chanting slogans denouncing its judges and inciting the people against them.”


The judges were prevented from entering “because of the threat of harm and danger to their safety,” the statement said, calling it “an abhorrent scene of shame and disgrace.”


As a result, the judges announced that they were “suspending the court’s sessions” until they could resume their work without “psychological and physical pressures.”


Anticipation of the court’s decision on the new constitution had set off the latest political crisis. Fear that the court would dissolve the assembly and undo months of work led President Mohamed Morsi, of the Muslim Brotherhood’s political party, to announce 10 days ago that his edicts were not be subject to judicial review until the completion of the constitution.


Despite Mr. Morsi’s attempt, the same anticipation of dissolution drove the Islamist-dominated assembly to rush out a hurried constitution before the court could act and against the objections of Egypt’s secular parties and the Coptic Christian Church. Judges appointed by Mr. Mubarak have previously dissolved the elected Parliament and the first constitutional assembly.


The sudden effort by the president and his Islamist allies to push through a constitution over any objections from their secular factions or the courts has unified the opposition, prompted hundreds of thousands of protesters to take to the streets and set off a wave of attacks on a dozen offices of the Brotherhood’s Freedom and Justice Party. A judicial trade association has urged judges across the country to go on strike, and some of the highest courts have joined it.


Over the weekend, Mr. Morsi continued to push his plans for the new constitution, setting a national referendum on it for Dec. 15.


“I pray to God and hope that it will be a new day of democracy in Egypt,” he said in a nationally televised speech, calling for a “national dialogue.”


But his recent tone and actions reminded critics of the autocratic ways of his predecessor, and have aroused a new debate here about his commitment to democracy and pluralism at a time when he and his Islamist allies dominate political life.


Mr. Morsi’s advisers call the tactics a regrettable but necessary response to genuine threats to the political transition from what they call the deep state — the vestiges of the autocracy of former President Mubarak, especially in the news media and the judiciary.


But his critics say they hear a familiar paranoia in Mr. Morsi’s new tone that reminds them of talk of the “hidden hands” and foreign plots that Mr. Mubarak once used to justify his authoritarianism.


“I have sent warnings to many people who know who they are, who may be committing crimes against the homeland,” Mr. Morsi declared in an interview with state television on Thursday night, referring repeatedly to secret information about a “conspiracy” and “real and imminent threats” that he would not disclose. “If anybody tries to derail the transition, I will not allow them.”


Mayy El Sheikh contributed reporting.



Read More..

Jets backup QB Tebow, Cards WR Roberts inactive

EAST RUTHERFORD, N.J. (AP) — New York Jets backup quarterback Tim Tebow is not active for the team's game against the Arizona Cardinals because of a rib injury.

Tebow has two broken ribs, suffered at Seattle on Nov. 11, and was limited in practice all week. Third-stringer Greg McElroy is active for the first time in his NFL career and will back up starter Mark Sanchez. Tebow was active Thanksgiving night against New England, but did not play.

Cardinals wide receiver Andre Roberts is out with an ankle injury, while defensive end Calais Campbell is sidelined with a calf injury. Starting quarterback Kevin Kolb is out for the sixth consecutive game, as expected, with a rib injury. Rookie Ryan Lindley is starting for the second straight game.

___

Online: http://pro32.ap.org/poll and http://twitter.com/AP_NFL

Read More..

Opinion: A Health Insurance Detective Story





I’VE had a long career as a business journalist, beginning at Forbes and including eight years as the editor of Money, a personal finance magazine. But I’ve never faced a more confounding reporting challenge than the one I’m engaged in now: What will I pay next year for the pill that controls my blood cancer?




After making more than 70 phone calls to 16 organizations over the past few weeks, I’m still not totally sure what I will owe for my Revlimid, a derivative of thalidomide that is keeping my multiple myeloma in check. The drug is extremely expensive — about $11,000 retail for a four-week supply, $132,000 a year, $524 a pill. Time Warner, my former employer, has covered me for years under its Supplementary Medicare Program, a plan for retirees that included a special Writers Guild benefit capping my out-of-pocket prescription costs at $1,000 a year. That out-of-pocket limit is scheduled to expire on Jan. 1. So what will my Revlimid cost me next year?


The answers I got ranged from $20 a month to $17,000 a year. One of the first people I phoned said that no matter what I heard, I wouldn’t know the cost until I filed a claim in January. Seventy phone calls later, that may still be the most reliable thing anyone has told me.


Like around 47 million other Medicare beneficiaries, I have until this Friday, Dec. 7, when open enrollment ends, to choose my 2013 Medicare coverage, either through traditional Medicare or a private insurer, as well as my drug coverage — or I will risk all sorts of complications and potential late penalties.


But if a seasoned personal-finance journalist can’t get a straight answer to a simple question, what chance do most people have of picking the right health insurance option?


A study published in the journal Health Affairs in October estimated that a mere 5.2 percent of Medicare Part D beneficiaries chose the cheapest coverage that met their needs. All in all, consumers appear to be wasting roughly $11 billion a year on their Part D coverage, partly, I think, because they don’t get reliable answers to straightforward questions.


Here’s a snapshot of my surreal experience:


NOV. 7 A packet from Time Warner informs me that the company’s new 2013 Retiree Health Care Plan has “no out-of-pocket limit on your expenses.” But Erin, the person who answers at the company’s Benefits Service Center, tells me that the new plan will have “no practical effect” on me. What about the $1,000-a-year cap on drug costs? Is that really being eliminated? “Yes,” she says, “there’s no limit on out-of-pocket expenses in 2013.” I tell her I think that could have a major effect on me.


Next I talk to David at CVS/Caremark, Time Warner’s new drug insurance provider. He thinks my out-of-pocket cost for Revlimid next year will be $6,900. He says, “I know I’m scaring you.”


I call back Erin at Time Warner. She mentions something about $10,000 and says she’ll get an estimate for me in two business days.


NOV. 8 I phone Medicare. Jay says that if I switch to Medicare’s Part D prescription coverage, with a new provider, Revlimid’s cost will drive me into Medicare’s “catastrophic coverage.” I’d pay $2,819 the first month, and 5 percent of the cost of the drug thereafter — $563 a month or maybe $561. Anyway, roughly $9,000 for the year. Jay says AARP’s Part D plan may be a good option.


NOV. 9 Erin at Time Warner tells me that the company’s policy bundles United Healthcare medical coverage with CVS/Caremark’s drug coverage. I can’t accept the medical plan and cherry-pick prescription coverage elsewhere. It’s take it or leave it. Then she puts CVS’s Michele on the line to get me a Revlimid quote. Michele says Time Warner hasn’t transferred my insurance information. She can’t give me a quote without it. Erin says she will not call me with an update. I’ll have to call her.


My oncologist’s assistant steers me to Celgene, Revlimid’s manufacturer. Jennifer in “patient support” says premium assistance grants can cut the cost of Revlimid to $20 or $30 a month. She says, “You’re going to be O.K.” If my income is low enough to qualify for assistance.


NOV. 12 I try CVS again. Christine says my insurance records still have not been transferred, but she thinks my Revlimid might cost $17,000 a year.


Adriana at Medicare warns me that AARP and other Part D providers will require “prior authorization” to cover my Revlimid, so it’s probably best to stick with Time Warner no matter what the cost.


But Brooke at AARP insists that I don’t need prior authorization for my Revlimid, and so does her supervisor Brian — until he spots a footnote. Then he assures me that it will be easy to get prior authorization. All I need is a doctor’s note. My out-of-pocket cost for 2013: roughly $7,000.


NOV. 13 Linda at CVS says her company still doesn’t have my file, but from what she can see about Time Warner’s insurance plans my cost will be $60 a month — $720 for the year.


CVS assigns my case to Rebecca. She says she’s “sure all will be fine.” Well, “pretty sure.” She’s excited. She’s been with the company only a few months. This will be her first quote.


NOV. 14 Giddens at Time Warner puts in an “emergency update request” to get my files transferred to CVS.


Frank Lalli is an editorial consultant on retirement issues and a former senior executive editor at Time Warner’s Time Inc.



Read More..

John McAfee Plays Hide-and-Seek in Belize


Photo Illustration by The New York Times


John McAfee, right, a pioneer in computer security who lives in Belize, is a “person of interest” in the murder of his neighbor. More Photos »





DANIEL GUERRERO promised during his campaign for mayor here to clean up San Pedro, the only town on this island, a 20-minute puddle jump from the mainland. But if he ever runs for re-election, don’t expect him to mention that vow.


“I meant clean up the trash, the traffic, that sort of thing,” he says. “I didn’t mean this.”


“This” is a full-blown international media frenzy and the kind of mess that no politician could have seen coming. It started on Nov. 11, the morning that Gregory Faull, a 52-year-old American, was found dead, lying face up in a pool of blood in his home. He had been shot in the head. His laptop and iPhone were missing. A 9-millimeter shell was found nearby.


What happened next turned this from a local crime story to worldwide news: The police announced that a “person of interest” in the investigation was a neighbor, John McAfee, a Silicon Valley legend who years ago earned millions from the computer virus-fighting software company that still bears his name.


A priapic 67-year-old, with an improbable mop of blond-highlighted hair and a rotating group of young girlfriends, Mr. McAfee quickly melted into the island’s lush green forest. Then, for Belizean authorities, the real embarrassment began.


Asserting his innocence, Mr. McAfee became a multiplatform cyberdissident, with a Twitter account, and a blog at whoismcafee.com with audio links, a comments section, photographs and a stream of invective against the government and the police of Belize. He has done interviews on podcasts, like the “Joe Rogan Experience,” and offered a $25,000 reward for information leading to the arrest of “the person or persons” who killed Mr. Faull. He has turned lamming it into a kind of high-tech performance art.


“I am asking all people of conscience to read this blog, especially the links in the ‘Background’ section,’ and see the ugly truth unfolding here,” he posted on Nov. 18. “Speak out. Write your congressmen. Write the prime minister. Do what you can.”


Before he went underground, Mr. McAfee led a noisy, opulent and increasingly stressful life here. He was known for the retinue of prostitutes who he says moved in and out of his house, and for employing armed guards, some of whom stood watch on the beach abutting his house. He also kept a pack of untethered dogs on his property who barked at and sometimes bit passers-by.


Two days before the murder, someone had poisoned a handful of those dogs. As it happens, Mr. Faull had complained about the animals, as well as the guards and the constant late-night inflow and outflow of taxis on the dirt path that runs behind his and Mr. McAfee’s homes — a path so tiny that it’s supposed to be off-limits to cars.


Mr. Faull had shown up at the town council office a few weeks ago with a letter decrying the din and the dogs, as well as Mr. McAfee’s guns and behavior. Nothing came of it.


“We were planning to meet with John McAfee and hand him the letter,” Mr. Guerrero said. “But it never happened. We were busy doing other work.”


In hindsight, that looks like a blunder. Mr. McAfee has since said on his blog that he had no choice but to flee because police and politicians in Belize are corrupt and eager to kill him. As proof, he has written at length about a late April raid that the country’s Gang Suppression Unit conducted at a property of his on the mainland, in a district called Orange Walk.


Some McAfee watchers have a different theory — namely, that he grew paranoid and perhaps psychotic after months of experimenting with and consuming MDPV, a psychoactive drug. These experiments were described in detail by Mr. McAfee himself, under the pseudonym “Stuffmonger” in a forum on Bluelight, a Web site popular with drug hobbyists.


So, here’s one hypothesis: Rich man doses himself to madness while seeking sexual bliss through pharmacology. Then shoots neighbor in a rage. Case closed, right? Ah, but those Bluelight posts were a ruse, Mr. McAfee would later blog, just one of the many pranks he has perpetrated over the years — part of a bet with a friend to see if he could create Bluelight’s largest-ever thread.


Read More..

KC police: Chiefs player involved in shootings

KANSAS CITY, Mo. (AP) — Police say a 25-year-old Kansas City Chiefs player was involved in two shootings Saturday, one of which occurred in the parking lot near Arrowhead Stadium.

Kansas City police Supervisor Andrea Khan could not release the name of the player involved. The condition of the two parties was not immediately known.

Khan said the first shooting happened in a Kansas City, Mo., neighborhood and the second happened at Arrowhead Stadium, about five miles away, at about 8 a.m. Saturday.

The Chiefs issued a statement saying, "We can confirm that there was an incident at Arrowhead earlier this morning. We are cooperating with authorities in their investigation."

Read More..

Israel Moves to Expand Settlements in East Jerusalem


Ronen Zvulun/Reuters


Construction in the West Bank settlement of Maale Adumim last June. More Photos »







JERUSALEM — As the United Nations General Assembly voted overwhelmingly to upgrade the Palestinians’ status Thursday night, Israel took steps toward building housing in a controversial area of East Jerusalem known as E1, where Jewish settlements have long been seen as the death knell for a two-state solution to the Israeli-Palestinian conflict.




A senior Israeli official, speaking on the condition of anonymity, said on Friday that the decision was made late Thursday night to move forward on “preliminary zoning and planning preparations” for housing units in E1, which would connect the large settlement of Maale Adumim to Jerusalem and therefore make it impossible to connect the Palestinian cities of Ramallah and Bethlehem to Palestinian neighborhoods of East Jerusalem. Israel also authorized the construction of 3,000 housing units in other parts of East Jerusalem and the West Bank, the official said.


The prime minister’s office refused to comment on whether the settlement expansion — first reported on Twitter by a reporter for the Israeli daily Haaretz — was punishment for the Palestinians’ success in obtaining nonmember observer state status at the United Nations, but it was widely seen as such. The United States, one of only eight countries that stood with Israel in voting against the Palestinians’ upgrade, has for two decades vigorously opposed construction in E1, a 3,000-acre expanse of hilly parkland where a police station was opened in 2008.


Hagit Ofran, who runs the Settlement Watch project of Peace Now, called E1 a “deal breaker for the two-state solution” and decried the decision as “disastrous.”


“Instead of punishing the Palestinians, they are actually punishing Israel,” Ms. Ofran, who is Israeli, said in an interview. “Instead of taking advantage of this bid in the U.N. and calling for negotiations to get to a two-state solution, this government is choosing to take actions that might prevent the possibility of a two-state solution.”


Read More..

Saints' Vilma, Smith attend Williams hearing

WASHINGTON (AP) — Right from the start, the NFL said Gregg Williams was in charge of a pay-for-pain bounty system with the New Orleans Saints.

The former defensive coordinator — who told the league about others' involvement — was being cross-examined Friday by lawyers for players appealing their suspensions in the case.

And two of those players, Saints linebacker Jonathan Vilma and defensive lineman Will Smith, attended Williams' session.

"We all know why we're here today," Vilma said Friday on his way into the hearing.

The hearing is part of the latest round of player appeals overseen by former NFL Commissioner Paul Tagliabue. Former Saints assistant coach Mike Cerullo faced questions Thursday, when lawyers for the league and for players spent more than nine hours in a Washington office building.

Tagliabue and various lawyers declined to comment Thursday or Friday.

Vilma and Smith traveled to Washington after playing in New Orleans' 23-13 loss at Atlanta on Thursday night.

Neither player was required to attend Friday, but Smith said this week that "part of the things that we wanted all along was to face our accusers."

Vilma and Smith — along with two former Saints, free-agent defensive lineman Anthony Hargrove and Cleveland Browns linebacker Scott Fujita — were suspended by the NFL for the Saints' cash-for-hits program that the league says Williams ran from 2009 to 2011.

Smith, suspended four games, and Vilma, suspended for the entire current season, have been playing while their appeals are pending.

The NFL has described Vilma and Smith as ringleaders of a performance pool designed to knock targeted opponents out of games. The league has sworn statements from Williams and Cerullo saying Vilma offered $10,000 to anyone who knocked quarterback Brett Favre out of the NFC championship game at the end of the 2009 season.

NFL Commissioner Roger Goodell issued the initial suspensions, which also included a full-season ban for Saints head coach Sean Payton.

Lawsuits brought by Vilma and the NFL Players Association to challenge Goodell's handling of the case, including his decision in October to appoint Tagliabue as the arbitrator for the appeals, are pending in federal court in New Orleans.

On Thursday, U.S. District Judge Ginger Berrigan gave the parties until Monday to answer questions about whether the NFL's collective bargaining agreement prevents a commissioner from handing out discipline for legal contact, and whether the CBA's passages about detrimental conduct are "ambiguous, hence unenforceable."

In March, the NFL announced that its investigation showed the Saints put together a bounty pool of up to $50,000 to reward game-ending injuries inflicted on opponents. "Knockouts" were worth $1,500 and "cart-offs" $1,000 — with payments doubled or tripled for the playoffs, the league said.

According to the league, the pay-for-pain program was administered by Williams, with Payton's knowledge. At the time, Williams apologized for his role, saying: "It was a terrible mistake, and we knew it was wrong while we were doing it."

Later that month, Payton became the first head coach suspended by the league for any reason — banned for all of this season without pay — and Williams was suspended indefinitely.

Williams was known for his aggressive, physical defenses as a coordinator for Tennessee, Washington, Jacksonville and New Orleans, and during his time as head coach of Buffalo. In January, he was hired by St. Louis to lead their defense.

___

Connect with Howard Fendrich on Twitter at http://twitter.com/HowardFendrich

___

Online: http://pro32.ap.org/poll and http://twitter.com/AP_NFL

Read More..

Ranbaxy, a Generic Drug Maker, Stops Making Cholesterol Pill


Ranbaxy Pharmaceuticals, the largest producer of the generic version of Lipitor, has halted production of the drug until it can figure out why glass particles may have ended up in pills that were distributed to the public, the Food and Drug Administration announced Thursday.


The agency said it had not received any reports of patients being harmed by the particles, which are about the size of a grain of sand. Earlier this month, Ranbaxy recalled more than 40 lots of the drug because of the glass contamination.


The company has declined to say where the drug was manufactured or why the problem occurred, but a spokeswoman for the F.D.A. said Thursday that the company would stop making the pill’s active ingredient, which is made in India, until the investigation is completed.


The contamination was the latest episode in a history of manufacturing lapses at Ranbaxy, which is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo. The company has been operating under a court-ordered consent decree since January, one that federal authorities have called “unprecedented in scope,” after they identified a host of manufacturing problems at the company’s plants in India and the United States, and concluded that Ranbaxy had submitted false data in drug applications to the F.D.A..


The decree prevents Ranbaxy from manufacturing drugs at its most troubled facilities until it can show it is meeting United States standards, although it was allowed to continue making products — including the generic version of Lipitor — at other plants.


The F.D.A. spokeswoman, Sarah Clark-Lynn, said the affected lots were not made at “the same facilities whose conduct gave rise to the consent decree.” Nonetheless, she said in an e-mail Monday, “the consent decree provides the F.D.A. with additional tools to address violations for other Ranbaxy facilities.”


A spokesman for Ranbaxy declined to comment beyond an informational statement on the company’s Web site.


Some drug manufacturing experts said Ranbaxy’s latest troubles highlight the disparities in oversight of plants in the United States versus those overseas. “I have pretty good faith in companies and plants that make drugs in this country because I know from my own experience that they try to do a good job,” said Prabir K. Basu, executive director of the National Institute for Pharmaceutical Technology and Education, who previously worked in manufacturing and global outsourcing for pharmaceutical companies, including Searle and Pharmacia. “But my confidence is not that high when we are getting products from outside the country.”


He pointed to studies that have shown the F.D.A. inspects foreign generic manufacturing plants about once every seven to 13 years, compared with once every two years for domestic manufacturers. A law passed over the summer will eventually require the F.D.A. to apply the same standards when inspecting all manufacturing plants, regardless of which country they’re in.


Allan Coukell, director of medical programs at the Pew Health Group and an expert on drug safety, said the new law would level what he described as an uneven playing field, but “it’s incumbent on F.D.A. to hire the staff and to make the shift to a risk-based inspection system.” Under the law, fees collected from generic manufacturers will help pay for more inspectors.


Mr. Basu said the law, called the Generic Drug User Fee Amendments of 2012 and known as Gdufa (Gah-doofuh) was a step in the right direction, but fixing the problem would require more than simply hiring more people. “This is a very difficult and complex system, and how do we ensure the integrity of this supply chain?” he said. “I don’t know how much Gdufa will help.”


Ranbaxy has held a significant share of the market for generic Lipitor, also known as atorvastatin, since it became one of the first companies to sell it after Pfizer lost patent protection for the top-selling drug last November; another company, Watson, sold a generic version that was authorized and manufactured by Pfizer. In October, Ranbaxy’s product accounted for 43 percent of prescriptions for atorvastatin, a widely used drug to lower cholesterol levels, according to an analysis by Michael Faerm, an analyst for Credit Suisse who used prescription data from the research firm IMS Health.


In its statement on Thursday, the F.D.A. said it did not expect a shortage of atorvastatin. Erin Fox, who tracks drug shortages as director of the Drug Information Service at the University of Utah, said drugs in pill form have long shelf lives and suppliers can keep large quantities in stock. Other generic manufacturers with approval to sell the drug include Apotex, Dr. Reddy’s Labs, Mylan, Sandoz, and Teva, according to the F.D.A. Web site.


Ranbaxy has posted a list of the recalled lots on its Web site, and has warned that patients should not stop taking the drug without guidance from their doctor. The lot numbers are found on the side of Ranbaxy pill bottles and the company advised patients to check with their pharmacist if customers received pills in a container dispensed by the pharmacy.


The agency said the potential for injury because of the contamination appeared to be low and “if any adverse events are experienced, they would be temporary.”


Read More..