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..

Jewel parent says sale talks proceeding

Exterior of Jewel-Osco's first "Green Store" located at 370 N. Desplaines in Chicago. (Antonio Perez / November 29, 2012)

By Emily Bryson York




Chicago Tribune reporter

6:51 a.m. CST, November 30, 2012

Supervalu, the Minneapolis-based parent of Jewel-Osco said sale talks are proceeding after stock closed down more than 18 percent Thursday, to $2.28.

The beleaguered grocery chain was likely moving to combat reports that sale talks with suitor Cerberus Capital Management had stalled over funding.

"The company continues to be in active discussion with several parties," according to the statement. "There can be no assurance that this process will result in any transaction or any change in the Company's overall structure or its business model."

Supervalu, the third-largest U.S. grocery chain, has acknowledged sale talks since the spring. The company has been closing stores and cutting jobs as it has underperformed competitors like Dominick's parent Safeway and Kroger.

If Supervalu does not sell to Cerberus, it may have to restructure on its own or sell off individual assets, which could have big tax consequences, Bloomberg said.

Reuters reported last month that buyout firm Cerberus was preparing a takeover bid for Supervalu, the third-largest U.S. supermarket chain.

Cerberus officials could not be reached immediately for comment.

-- Reuters contributed to this report

In addition to Jewel, Supervalu owns Albertsons, Cub and other regional grocery chains.

SVU data by YCharts

SVU data by YCharts

Read More..

Winning Powerball tickets sold in Arizona, Kansas City area

The winning numbers for the record Powerball jackpot were drawn Wednesday night. The numbers are 5, 16, 22, 23, 29 and Powerball 6. The jackpot rose to $579.9 million by the time of the drawing.

Two lucky ticket holders — one in Arizona and another in Missouri — are waking up Thursday to new lives as multimillionaires after the largest Powerball jackpot drawing ever.

Powerball officials said two tickets matched all six numbers to win the record $587.5 million jackpot. The numbers drawn for Wednesday night, for the second-highest jackpot in U.S. lottery history, are 5, 16, 22, 23, 29. The Powerball is 6.

It was not clear whether the winning tickets belonged to individuals or were purchased by groups.

One of the winning tickets was sold at a Trex Mart convenience store in Dearborn, Mo., about 35 miles north of Kansas City, the state lottery commission said in a news release.

Earlier Thursday, Missouri Lottery spokesman Gary Gonder said he was on his way to that store to assist with the expected onslaught of media attention. That store will be awarded $50,000 for selling the winning ticket.

"I guess we'll be able to give out Christmas bonuses," said Trex Mart General Manager Kenny Gilbert. "That's nice, especially at this time of year."

It did not appear Wednesday's big winner had yet come forward.

"If you buy Powerball tickets at this location, please find them and check them closely," said May Scheve Reardon, executive director of the Missouri Lottery. "If you find you're holding the winning ticket, be sure you sign the back and put it in a safe place until you can take it to a Missouri Lottery office. You will also want to get some legal and financial advice before you claim."

The winner has 180 days to claim their share in the prize money.

Arizona lottery officials said early Thursday they had no information on the Grand Canyon State's winner or winners, but they planned to announce Thursday morning where the ticket was sold.

Americans went on a ticket-buying spree in the run-up to Wednesday's drawing, the big money enticing many people who rarely, if ever, play the lottery to purchase a shot at the second-largest payout in U.S. history.

Tickets sold at a rate of 130,000 a minute nationwide — about six times the volume from a week ago. That pushed the jackpot even higher, said Chuck Strutt, executive director of the Multi-State Lottery Association. The jackpot rolled over 16 consecutive times without a winner.

Iowa Lottery spokeswoman Mary Neumauer said the jackpot was estimated at $587.5 million by early Thursday, adjusted slightly upward from the $579.9 million estimate at the time of the drawing. The cash payout was $384.7 million.

In a Mega Millions drawing in March, three ticket buyers shared a $656 million jackpot. This remains the largest lottery payout of all time.

Read More..

Lindsay Lohan arrested on assault charge in NYC

NEW YORK (AP) — Actress Lindsay Lohan was arrested Thursday after police said she hit a woman during an argument at a New York City nightclub.

The “Mean Girls” and “Freaky Friday” star was arrested at 4 a.m. and charged with third-degree assault.

She left a police precinct nearly four hours later with a black jacket pulled over her head. She was wearing leggings, a green mini skirt and high-heels, and drove off in a black SUV with a driver and another man who was seen going in and out of the precinct.

She allegedly got into the spat with another woman at Club Avenue, in Manhattan‘s Chelsea section. She struck the woman in face with her hand, police said. The woman did not require medical attention.

Lohan’s publicist did not immediately return a call for comment.

The arrest is Lohan’s latest brush with law enforcement in New York City.

She was involved in a NYPD investigation in September after alleging a man had assaulted her in a New York hotel, but charges against the man were later dropped.

Also in September, the actress was accused of clipping a man with her car outside another Manhattan nightclub, but prosecutors chose not to move ahead with charges.

In October, police were called to her childhood home on Long Island after a report of fight between her and her mother. An investigation revealed “no criminality.”

The actress was also involved in a car accident in California this summer that sent her and an assistant to a hospital, but didn’t result in serious injuries for anyone. The accident remains under investigation.

In May, she was cleared of allegations that she struck a Hollywood nightclub manager with her car.

Lohan remains on informal probation for taking a necklace from a jewelry store without permission last year. That means she doesn’t have to check in with a judge or probation officer but could face a jail term if arrested again.

Her latest film, “Liz & Dick,” in which she portrays screen icon Elizabeth Taylor, premiered on Lifetime on Sunday.

Lohan also recently filmed “The Canyons,” an indie film written by “Less Than Zero” and “American Psycho” author Bret Easton Ellis.

Entertainment News Headlines – Yahoo! News

Read More..

Medicare Is Faulted in Electronic Medical Records Conversion

The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators.

Mike Spencer/Wilmington Star-News, via Associated Press

Celeste Stephens, a nurse, leads a session on electronic records at New Hanover Regional Medical Center in Wilmington, N.C.

Centers for Medicare and Medicaid Services

Marilyn Tavenner, acting administrator for Medicare.

The use of electronic medical records has been central to the aim of overhauling health care in America. Advocates contend that electronic records systems will improve patient care and lower costs through better coordination of medical services, and the Obama administration is spending billions of dollars to encourage doctors and hospitals to switch to electronic records to track patient care.

But the report says Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions.

Medicare “faces obstacles” in overseeing the electronic records incentive program “that leave the program vulnerable to paying incentives to professionals and hospitals that do not fully meet the meaningful use requirements,” the investigators concluded. The report was prepared by the Office of Inspector General for the Department of Health and Human Services, which oversees Medicare.

The investigators contrasted the looser management of the incentive program with the agency’s pledge to more closely monitor Medicare payments of medical claims. Medicare officials have indicated that the agency intends to move away from a “pay and chase” model, in which it tried to get back any money it has paid in error, to one in which it focuses on trying to avoid making unjustified payments in the first place.

Late Wednesday, a Medicare spokesman said in a statement: “Protecting taxpayer dollars is our top priority and we have implemented aggressive procedures to hold providers accountable. Making a false claim is a serious offense with serious consequences and we believe the overwhelming majority of doctors and hospitals take seriously their responsibility to honestly report their performance.”

The government’s investment in electronic records was authorized under the broader stimulus package passed in 2009. Medicare expects to spend nearly $7 billion over five years as a way of inducing doctors and hospitals to adopt and use electronic records. So far, the report said, the agency has paid 74, 317 health professionals and 1,333 hospitals. By attesting that they meet the criteria established under the program, a doctor can receive as much as $44,000 for adopting electronic records, while a hospital could be paid as much as $2 million in the first year of its adoption. The inspector general’s report follows earlier concerns among regulators and others over whether doctors and hospitals are using electronic records inappropriately to charge more for services, as reported by The New York Times last September, and is likely to fuel the debate over the government’s efforts to promote electronic records. Critics say the push for electronic records may be resulting in higher Medicare spending with little in the way of improvement in patients’ health. Thursday’s report did not address patient care.

Even those within the industry say the speed with which systems are being developed and adopted by hospitals and doctors has led to a lack of clarity over how the records should be used and concerns about their overall accuracy.

“We’ve gone from the horse and buggy to the Model T, and we don’t know the rules of the road. Now we’ve had a big car pileup,” said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago. The association, which contends more study is needed to determine whether hospitals and doctors actually are abusing electronic records to increase their payments, says it supports more clarity.

Although there is little disagreement over the potential benefits of electronic records in reducing duplicative tests and avoiding medical errors, critics increasingly argue that the federal government has not devoted enough time or resources to making certain the money it is investing is being well spent.

House Republicans echoed these concerns in early October in a letter to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. “The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments,” said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.

In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it “would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff.” She said Medicare was trying to determine whether electronic records had been used in any fraudulent billing but she insisted that the current efforts to certify the systems and address the concerns raised by the Republicans and others were adequate.

Read More..

French court clears Continental in Concorde crash

French appeals court on Thursday absolved Continental Airlines of blame for a 2000 Concorde crash that killed 113 people and cleared a mechanic at the U.S. airline of the charge of involuntary manslaughter.

The verdict comes over a decade after the accident helped to spell the end of the supersonic airliner. A previous court ruled that a small metal strip that fell onto the runway from a Continental aircraft just before the Concorde took off from Paris, caused the crash.

Continental was originally fined 200,000 euros and ordered to pay the Concorde's operator, Air France, a million euros in damages. Continental appealed the verdict which it described as unfair and absurd.

Welder John Taylor was cleared of a 15-month suspended prison sentence for having gone against industry norms and used titanium to forge the piece that dropped off the plane.

Continental, now part of United Continental Holdings , had been ordered under the original ruling to pay 70 percent of any damages payable to families of victims. Airbus parent EADS would have to pay the other 30 percent.

The crash sped up the demise of the droop-nosed Concorde - the fastest commercial airliner in history and a symbol of Franco-British co-operation - as safety concerns coupled with an economic downturn after 9/11 drove away its wealthy customers.

The Air France Concorde, carrying mostly German tourists bound for a Caribbean cruise, was taking off from Paris on July 25, 2000 when an engine caught fire. Trailing a plume of flames, it crashed into a hotel near Charles de Gaulle airport. All 109 passengers and four people on the ground died.

After modifications, the plane returned to service but its operators, Air France and British Airways, retired it in 2003, citing high operating costs and a drop in demand.
 

Read More..

Powerball sales 'blistering' as jackpot hits $500 million

The Illinois Lottery says Powerball tickets are selling at a "blistering" pace as the jackpot reached $500 million.

Over a 30-minute period around the middle of the day Tuesday, the Illinois Lottery sold more than $200,000 in Powerball tickets across the state.

Lottery officials expected the pace of sales to increase even more ahead of tonight's drawing for the largest jackpot in Powerball history.

A $656 million Mega Millions jackpot set a world lottery record in March. That prize was split three ways. One of the winning tickets was held by Merle and Patricia Butler of Red Bud in southern Illinois. The retired couple took home nearly $119 million.

Powerball has not had a winner for two months, and the pot has already grown by nearly $175 million due to brisk ticket sales after no one won the top prize in Saturday's drawing.

The next drawing for the prize on Wednesday night would dish out a whopping $327.4 million and counting if paid as a lump sum. Alternatively, the $500 million can be paid out in an annuity over three decades.Powerball is sold in 42 states,Washington, D.C., and the U.S. Virgin Islands.

There have been nearly 300 jackpot winners over the past 20 years, taking home payouts of over $11.6 billion.

Among dreamers across the nation lining up at an Arizona grocery store in Tucson for a shot at Wednesday's prize was metal shop worker Errol Simmons, 54, entrusted with a list of lucky numbers by a dozen or so co-workers.

"I've got to get this right," he said as he checked through the list. "I don't want to be the guy who lost us half a billion dollars because I couldn't count.

"If we win, I'll buy a new truck," he said. "For each day of the week."

Looking sharp in a blue pin striped suit, Portland, Oregon, financial adviser Aaron Pearson, 36, said he was taking care to pick his own numbers for the first time - although he was unsure what he would do with the huge jackpot should he win.

"I have no idea. I'd invest it and live off of it. I'd give to charities. I'd start a foundation," he mused.

The chance of winning the jackpot are about one in 175 million, compared to about one in 280,000 for being struck by lightning.

Despite the long odds, the record payout has drawn interest from around the world, said Mary Neubauer, a spokeswoman for the Iowa Lottery, where Powerball is based. Lottery officials have received calls and emails from people outside the United States asking if they can buy a ticket from afar. They cannot.

"Sales across the country are just through the roof. It means lots of people are having fun with this, but it makes it difficult to keep up with the (jackpot) estimate."

The previous top Powerball prize of $365 million was won in 2006 by ConAgra slaughterhouse workers in Nebraska.

Associated Press and Reuters contributed

Read More..

Seattle police plan for helicopter drones hits severe turbulence

SEATTLE (Reuters) – One of the latest crime-fighting gadgets to emerge on the wish lists of U.S. law enforcement agencies – drone aircraft – has run into heavy turbulence in Seattle over a plan by police to send miniature robot helicopters buzzing over the city.

A recent push for unmanned police aircraft in several cities is being driven largely by grants from the U.S. Department of Homeland Security, including more than $ 80,000 the city of Seattle used to buy a pair of drone choppers in 2010.

But getting aerial drones off the ground has run into stiff opposition from civil libertarians and others who say the use of stealth airborne cameras by domestic law enforcement raises questions about privacy rights and the limits of police search powers.

The aircraft would never carry weapons, but the use of drones for even mundane tasks raises ire among some because of the association of pilotless crafts with covert U.S. missile strikes in places such as Pakistan and Yemen.

In Seattle last month, a community meeting where police officials presented plans to deploy their two remote-controlled helicopters erupted into yelling and angry chants of “No drones!”

“My question is simple: What’s the return policy for the drones?” said Steve Widmayer, 57, one of numerous citizens who spoke out against the unmanned aircraft. He predicted the City Council would commit “political suicide” if it backed the plan.

Seattle City Councilman Bruce Harrell said he hoped the council would set strict drone policies by January.

Police in Seattle, along with Florida’s Miami-Dade County and Houston, are among a handful of big-city law enforcement departments known to have acquired aerial drones. But those cities have not started operating the robot aircraft.

FEAR OF FLYING ROBOTS

In Oakland, California, this month, an Alameda County sheriff’s application for a federal grant to buy an aerial drone to help monitor unruly crowds and locate illegal marijuana farms drew opposition at a Board of Supervisors meeting.

“I do not want flying spy robots looking into my private property with infrared cameras,” Oakland resident Mary Madden said. “It’s an invasion of my privacy.”

County Board President Nate Miley said the issue would be taken up by the supervisors’ Public Protection Committee.

The two Draganflyer X6 remote-controlled miniature helicopters purchased by Seattle have so far been mostly grounded, restricted to training and demonstration flights.

Equipped to carry video, still and night-vision cameras, they can remain aloft for only 15 minutes at a time before their batteries run out, police said.

Assistant Police Chief Paul McDonagh said the aircraft would not be used in Seattle for surveillance or for monitoring street protests. Instead, his department’s plans to deploy drones to search for missing persons, pursue fleeing suspects, assist in criminal investigations and for unspecified “specific situations” subject to McDonagh’s approval.

Seattle City Councilman Bruce Harrell said he hoped the council would set strict drone policies by January.

Months ago in Texas, Chief Deputy Randy McDaniel of the Montgomery County Sheriff’s Office raised eyebrows by saying he hoped to equip his department’s drones with rubber bullets and tear gas, though he told Reuters his thinking on armed aircraft has since evolved.

“From a law enforcement standpoint, that’s never going to happen,” he said. McDaniel said his office received Federal Aviation Administration clearance earlier this month to begin operational drone flights but has not yet had occasion to do so.

Actual U.S. domestic use of law-enforcement drone aircraft remains extremely limited.

The Mesa County Sheriff’s Department in Colorado has been operating two small drones, also bought with Homeland Security funds, since 2010.

It uses them largely to create three-dimensional images of crime scenes, said Benjamin Miller, director of the department’s drone program. They are not used for surveillance, he said.

In North Dakota, the Grand Forks police department last year called in a high-flying Predator drone operated by the U.S. Department of Homeland Security to monitor a tense standoff with a rancher over alleged stolen cattle.

The rancher, Rodney Brossart, and five family members are believed to be the first Americans nabbed by police with drone assistance – with the possible exception of operations along the southwest border with Mexico.

The use of drones there by the Customs and Border Protection agency – a part of Homeland Security – led to 7,500 arrests and the seizure of thousands of pounds of drugs up to the end of last year.

The nationality of those arrested in drone assisted operations in the borderlands is not clear, nor is if Customs and Border Protection partnered with local forces in any of those arrests.

(Editing by Steve Gorman and Jackie Frank)

Gadgets News Headlines – Yahoo! News

Read More..

Rihanna’s “Unapologetic” tops Billboard album chart

LOS ANGELES (Reuters) – R&B singer Rihanna shot straight to the top of the Billboard 200 album chart on Tuesday with her seventh record “Unapologetic,” scoring her first No. 1 album despite mixed reviews.

“Unapologetic,” which topped iTunes charts in 43 countries just hours after its release on November19, sold 238,000 copies according to Billboard, scoring the 24-year-old singer from Barbados her best opening sales week to date.

The album’s lead single “Diamonds” landed at the top of the Billboard Hot 100 chart last week, giving Rihanna her 12th No. 1 single and tying her with Madonna and The Supremes for the fourth-most chart-topping singles in Billboard history.

“Unapologetic” left some critics unsettled by the singer’s harder sound and close-to-home lyrics. One track in particular that had everyone talking is “Nobody’s Business,” Rihanna’s collaboration with ex-boyfriend Chris Brown, who was charged with assaulting her three years ago.

The album has been promoted extensively by Rihanna, who embarked on a seven day tour across seven cities around the world, accompanied by a plane full of fans and journalists.

The full Billboard charts will be released on Wednesday.

(Reporting By Piya Sinha-Roy, editing by Jill Serjeant)

Music News Headlines – Yahoo! News

Read More..

Nurses Sue Douglas Kennedy for $200,000

Yana Paskova for The New York Times

Two nurses have accused Douglas Kennedy, a son of Robert F. Kennedy, of assault and battery, negligence and causing them emotional and physical distress after an episode involving his newborn son.

Two nurses in Westchester County have filed a $200,000 lawsuit against Douglas Kennedy, a son of Robert F. Kennedy, accusing him of assault and battery, negligence and causing them emotional and physical distress after an episode involving his newborn son.

The Journal News of Westchester reported that the lawsuit was filed on Tuesday, a week after a court in Mount Kisco, N.Y., acquitted Mr. Kennedy of child-endangerment and harassment charges.

The charges stemmed from Mr. Kennedy’s attempt in January to take his newborn son from a maternity ward.

The two nurses said Mr. Kennedy hurt them as they tried to prevent him from leaving with the newborn. Mr. Kennedy said he was just taking the baby outside for some fresh air.

In a statement, Mr. Kennedy vowed to fight the lawsuit and said it was an attempt to extort money from his family.

Read More..