FDA advisory panel backs efficacy of J&J TB drug

(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Wednesday voted that data suggest an experimental Johnson & Johnson drug for multidrug-resistant tuberculosis is effective, the drugmaker said.

The medicine, called bedaquiline, is a member of a new class of drugs that target adenosine triphosphate synthase, an enzyme the tuberculosis bacterium needs to generate its energy.

J&J said the panel of outside medical experts, in a vote of 18 to 0, found that trial data support the efficacy of bedaquiline in adults, taken in combination with standard treatments.

In September, the FDA granted priority review of the medicine, based on data from two mid-stage trials that tested it among patients with tuberculosis that is resistant to standard drugs.

J&J is hoping the agency will grant accelerated approval of the drug, on the basis of favorable data from mid-stage trials. The company plans to begin a larger Phase 3 study in the fourth quarter.

In a pair of completed Phase 2 trials, two doses of the medicine were tested for 24 weeks, in combination with standard treatments, followed by continuation of standard therapy for a year to 18 months.

The planned larger trial will involve nine months of treatment with bedaquiline, in combination with standard drugs, compared with standard drugs alone for the same period. The total nine-month treatment period would be far shorter than the current 18- to 24-month treatment period for multidrug-resistant tuberculosis drugs recommended by the World Health Organization, J&J said.

Cowen and Co has forecast peak annual sales of $ 300 million for bedaquiline, which would make it a fairly modest product for the diversified healthcare company.

Multidrug-resistant tuberculosis is caused by strains of the bacterium that have become resistant to at least isoniazid and rifampin, the two most potent drugs for TB.

Resistance to anti-TB drugs can occur when they are misused or mismanaged, for instance when patients don’t complete their full course of treatment or when doctors prescribe the wrong treatment, wrong dose or length of time taking the drugs.

An estimated 8.7 million people in 2011 fell ill with tuberculosis – which is spread by coughing and sneezing — while 1.4 million died from the disease, according to the World Health Organization. About 310,000 cases of multidrug-resistant TB were reported the same year, the organization said, with almost 60 percent in India, China and Russia.

(Reporting by Ransdell Pierson; Editing by Jan Paschal and Carol Bishopric)

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Two winners in record Powerball jackpot

Winning tickets for the record Powerball jackpot worth more than $587 million were purchased in Arizona and Missouri.

Missouri Lottery official Susan Goedde confirmed to ABC News this morning that one of the winning tickets was purchased in the state, but they would not announce which town until later this morning.

Arizona lottery officials said they had no information on that state's winner or winners but would announce where it was sold during a news conference later in the day.

The winning numbers for the jackpot were 5, 23, 16, 22 and 29. The Powerball was 6.

The jackpot swelled to $587.5 million, according to Lottery official Sue Dooley. The two winners will split the jackpot each getting $293.75 million. The cash payout is $192.5 million each.

An additional 8,924,123 players won smaller prizes, according to Powerball's website.

"There were 58 winners of $1 million and there were eight winners of $2 million. So a total of $74 million," said Chuck Strutt, Director of the Multi-State Lottery Association.

In Photos: Biggest Lotto Jackpot Winners

This is the 27th win for Missouri, ranking it second in the nation for lottery winners after Indiana, which has 38 wins. Arizona has had 10 Powerball jackpot wins in its history.

Players bought tickets at the rate of 131,000 every minute up until an hour before the deadline of 11 p.m. ET, according to lottery officials.

The jackpot had already rolled over 16 consecutive times without a winner. That fact, plus the doubling in price of a Powerball ticket, accounted for the unprecedented richness of the pot.

"Back in January, we moved Powerball from being a $1 game to $2," said Mary Neubauer, a spokeswoman at the game's headquarters in Iowa. "We thought at the time that this would mean bigger and faster-growing jackpots."

That proved true. The total, she said, began taking "huge jumps -- another $100 million since Saturday." It then jumped another $50 million.

The biggest Powerball pot on record until now -- $365 million -- was won in 2006 by eight Lincoln, Neb., co-workers.
As the latest pot swelled, lottery officials said they began getting phone calls from all around the world.

"When it gets this big," said Neubauer, "we get inquiries from Canada and Europe from people wanting to know if they can buy a ticket. They ask if they can FedEx us the money."

The answer she has to give them, she said, is: "Sorry, no. You have to buy a ticket in a member state from a licensed retail location."

About 80 percent of players don't choose their own Powerball number, opting instead for a computer-generated one.
Asked if there's anything a player can do to improve his or her odds of winning, Neubauer said there isn't -- apart from buying a ticket, of course.

Lottery officials put the odds of winning this Powerball pot at one in 175 million, meaning you'd have been 25 times more likely to win an Academy Award.

Skip Garibaldi, a professor of mathematics at Emory University in Atlanta, provided additional perspective: You are three times more likely to die from a falling coconut, he said; seven times more likely to die from fireworks, "and way more likely to die from flesh-eating bacteria" (115 fatalities a year) than you are to win the Powerball lottery.

Segueing, then, from death to life, Garibaldi noted that even the best physicians, equipped with the most up-to-date equipment, can't predict the timing of a child's birth with much accuracy.

"But let's suppose," he said, "that your doctor managed to predict the day, the hour, the minute and the second your baby would be born."

The doctor's uncanny prediction would be "at least 100 times" more likely than your winning.

Even though he knows the odds all too well, Garibaldi said he usually plays the lottery.

When it gets this big, I'll buy a couple of tickets," he said. "It's kind of exciting. You get this feeling of anticipation. You get to think about the fantasy."

So, did he buy two tickets this time?

"I couldn't," he told ABC News. "I'm in California" -- one of eight states that doesn't offer Powerball.

In case you were wondering, this Saturday's Powerball jackpot is starting at $40 million.

ABC News Radio contributed to this report.

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US rabbi says jailed American in good health

HAVANA (AP) — A prominent New York rabbi and physician visited an American subcontractor serving a long jail term in Cuba and said the man is in good health, despite his family’s concerns about a growth on his right shoulder.

Rabbi Elie Abadie, who is also a gastroenterologist, told The Associated Press in an exclusive interview following Tuesday’s 2 1/2-hour visit at a military hospital in Havana that he personally examined Alan Gross and received a lengthy briefing from a team of Cuban physicians who have attended him.

He said the 1 1/2-inch growth on Gross’s shoulder appeared to be a non-cancerous hematoma that should clear up by itself.

“Alan Gross does not have any cancerous growth at this time, at least based on the studies I was shown and based on the examination, and I think he understands that also,” Abadie said.

Abadie said the hematoma, basically internal bleeding linked to the rupture of muscle fiber, was likely caused by exercise Gross does in jail. He said the growth ought to eventually disappear on its own.

Gross’s plight has put already chilly relations between Cuba and the United States in a deep freeze. The Maryland native was arrested in December 2009 while on a USAID-funded democracy building program and later sentenced to 15 years in jail for crimes against the state.

He claims he was only trying to help the island’s small Jewish community gain Internet access.

Gross’s health has been an ongoing issue during his incarceration. The 63-year-old, who was obese when arrested, has lost more than 100 pounds while in jail.

Abadie, a rabbi at New York’s Edmund J. Safra Synagogue, said Gross’s weight is appropriate for a man his age and height.

Photos that Abadie and a colleague provided to AP of Tuesday’s meeting with Gross showed him looking thin, but generally appearing to be in good spirits.

In one photo, Gross holds up a handwritten note that says “Hi Mom.”

“He definitely feels strong. He is in good spirits. He feels fit, to quote him, physically. But of course, like any other person who is incarcerated or in prison, he wants to be free. He wants to be able to go back home,” Abadie said.

Gross’s family has repeatedly appealed for his release on humanitarian grounds, noting his health problems and the fact that his adult daughter and elderly mother have both been battling cancer.

Jared Genser, counsel to Alan Gross, said late Tuesday that Rabbi Abadie is not Gross’s physician and he would like an oncologist of his choosing to evaluate him.

“While we are grateful Rabbi Abadie was able to see Alan, we have asked an oncologist to review the test results to determine if they are sufficient to rule out cancer. More importantly, if Alan is so healthy, we cannot understand why the Cuban government has repeatedly denied him an independent medical examination by a doctor of his choosing as is required by international law,” said Genser.

Gross and his wife recently filed a $ 60 million lawsuit against his former Maryland employer and the U.S. government, saying they didn’t adequately train him or disclose risks he was undertaking by doing development work on the Communist-run island.

They filed another lawsuit against an insurance company they say has reneged on commitments to pay compensation in case of his wrongful detention.

Separately, a lawyer for Gross has written the United Nations’ anti-torture expert, saying Cuban officials’ treatment of his client “will surely amount to torture” if he continues to be denied medical care.

Rumors have been swirling in U.S. media that Cuba might soon release Gross as a gesture of good will or in the hopes of winning concessions from the administration of President Barack Obama, but Abadie said that those reports appeared to be false.

“As far as I know there is no truth to it,” he said.

Abadie said he met with senior Cuban officials who expressed their desire to resolve the case “as quickly as possible,” but would not say specifically who he spoke with or what they offered.

“They claim that they are more than willing to sit at the table,” he said.

Cuban officials have strongly implied they hope to trade Gross for five Cuban agents sentenced to long jail terms in the United States, one of whom is already free on bail.

Abadie said Gross made clear that he does not want his case linked to that of the agents, known in Cuba as “The Five Heroes,” because he does not believe he is guilty of espionage.

But Abadie said Gross is hoping for a “constructive and productive” dialogue between U.S. and Cuban officials to resolve his case.

___

Follow Paul Haven on Twitter: http://www.twitter.com/paulhaven.

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Nokia wins tribunal ruling on wireless patents

HELSINKI (Reuters) – Nokia has won its dispute with BlackBerry maker Research In Motion (RIM) over use of its patents related to wireless local access network (WLAN) technology, the Finnish company said on Wednesday.

Announcing that an arbitrator had ruled in its favor, Nokia said: “It found that RIM was in breach of contract and is not entitled to manufacture or sell WLAN products without first agreeing royalties.”

Nokia, which is trying to boost its royalty income as its phone business tumbles, said that it had filed cases in the United States, Britain and Canada to enforce the arbitrator’s ruling.

“This could have a significant financial impact, as all BlackBerry devices support WLAN, although the volumes are currently very low in these countries,” IDC analyst Francisco Jeronimo said.

RIM was not immediately available to comment.

Nokia said it signed a cross-license agreement with RIM covering standards-essential cellular patents in 2003; a deal that was amended in 2008. RIM sought arbitration in 2011, arguing that the license should be extended to cover WLAN patents.

Nokia, along with Ericsson and Qualcomm, is among the leading patent holders in the wireless industry. Patent royalties generate annual revenue of about 500 million euros ($ 646 million) for Nokia.

Based on a Nortel patent sale and Google’s acquisition of Motorola Mobility, some investors and analysts say that Nokia’s patent portfolio alone merits its current share price of 2.50 euros.

However, the patent market has cooled since those deals were made and industry experts say that fair value of patents in large portfolios is $ 100,000 to $ 200,000, pricing Nokia’s portfolio at up to 0.50 euros per share. ($ 1 = 0.7733 euros)

(Editing by David Goodman)

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Soy unlikely to help hot flashes

NEW YORK (Reuters Health) – Women who eat a lot of soy-based foods or fiber don’t seem to have fewer menopause symptoms, according to a new study.

The findings add to other studies that have found no benefits from eating extra amounts of soy, a food abundant in dietary estrogen.

“It might be a dead end,” said William Wong, a professor at Baylor College of Medicine who has studied the effects of soy protein on menopause symptoms.

Plant-based estrogens, also called phytoestrogens, are found in foods such as seeds, nuts and soybeans. Their chemical structure is similar to human estrogens.

Hormone replacement therapy, based on estrogen among other hormones, is effective in reducing hot flashes and other menopause symptoms, but carries some risks of heart disease and cancer, a large federally funded study released a decade ago found.

Researchers have been testing whether plant estrogens can offer benefits, perhaps without the risks.

“Many women can’t or don’t want to take hormones,” making dietary estrogen an appealing alternative, said Ellen Gold, the lead author of the study and a professor at the University of California Davis School of Medicine.

But studies on plant estrogens have been mixed.

A review of 17 studies on soy supplements has found that the pills can reduce the frequency and severity of hot flashes, while some individual trials on soy protein pills have found no benefits (see Reuters Health reports of April 27, 2012 http://reut.rs/K95gLr and August 8, 2011 http://reut.rs/prmTwt).

To see if women who choose to eat more phytoestrogens have an easier time through menopause, Gold and her colleagues tracked 1,651 women for 10 years.

At the beginning of the study, none of the women had gone through menopause.

Each year the researchers followed up with them to gather any reports of hot flashes or night sweats, and every few years the women filled out a food survey.

By the end of the study, Gold’s team could find no consistent pattern between the amount of phytoestrogens eaten and how often or how severely women experienced hot flashes and night sweats.

The same was true for how much fiber the women ate.

In some cases, the researchers did see a relationship between one type of dietary estrogen and menopause symptoms, but it didn’t always carry through when they examined women of different ethnicities or looked at different points in time.

Those apparent results, they write in the journal Menopause, may have been due to chance.

Gold said it’s possible that for some subsets of women, plant estrogens might have a benefit, but they weren’t able to tease that out in this study.

“I think the more promising avenue for us in the future is to see if there are some women who might benefit,” she told Reuters Health.

Wong, who was not part of the study, is less optimistic because of the negative results seen in long term studies of women taking soy protein supplements.

“After looking at our own clinical trial data and others, we don’t see it,” he told Reuters Health. “I think we should move on.”

SOURCE: http://bit.ly/Uq77iV Menopause, October 29, 2012.

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Powerball fever grips country

With 47 percent of the popular vote, Mitt Romney may become the president of nothing more than Ironystan. Yes, the final general-election tally is trickling in and, as fate would have it, Romney's total might look more like that mythical number after all. Well, according to David Wasserman of the Cook Political report, it's more like 47.49 and dropping, which, of course rounds down to 47 — the same percentage of Americans he said were moochers and takers in a video that was one of the nails in the coffin of his presidential campaign.

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Mexican beauty queen killed in shootout

CULIACAN, Mexico (AP) — A 20-year-old state beauty queen died in a gun battle between soldiers and the alleged gang of drug traffickers she was traveling with in a scene befitting the hit movie “Miss Bala,” or “Miss Bullet,” about Mexico’s not uncommon ties between narcos and beautiful pageant contestants.

The body of Maria Susana Flores Gamez was found Saturday lying near an assault rifle on a rural road in a mountainous area of the drug-plagued state of Sinaloa, the chief state prosecutor said Monday. It was unclear if she had used the weapon.

“She was with the gang of criminals, but we cannot say whether she participated in the shootout,” state prosecutor Marco Antonio Higuera said. “That’s what we’re going to have to investigate.”

The slender, 5-foot-7-inch brunette was voted the 2012 Woman of Sinaloa in a beauty pageant in February. In June, the model competed with other seven contestants for the more prestigious state beauty contest, Our Beauty Sinaloa, but didn’t win. The Our Beauty state winners compete for the Miss Mexico title, whose holder represents the country in the international Miss Universe.

Higuera said Flores Gamez was traveling in one of the vehicles that engaged soldiers in an hours-long chase and running gun battle on Saturday near her native city of Guamuchil in the state of Sinaloa, home to Mexico’s most powerful drug cartel. Higuera said two other members of the drug gang were killed and four were detained.

The shootout began when the gunmen opened fire on a Mexican army patrol. Soldiers gave chase and cornered the gang at a safe house in the town of Mocorito. The other men escaped, and the gunbattle continued along a nearby roadway, where the gang’s vehicles were eventually stopped. Six vehicles, drugs and weapons were seized following the confrontation.

It was at least the third instance in which a beauty queen or pageant contestants have been linked to Mexico’s violent drug gangs, a theme so common it was the subject of a critically acclaimed 2011 movie.

In “Miss Bala,” Mexico’s official submission to the Best Foreign Language Film category of this year’s Academy Awards, a young woman competing for Miss Baja California becomes an unwilling participant in a drug-running ring, finally getting arrested for deeds she was forced into performing.

In real life, former Miss Sinaloa Laura Zuniga was stripped of her 2008 crown in the Hispanoamerican Queen pageant after she was detained on suspicion of drug and weapons violations. She was later released without charges.

Zuniga was detained in western Mexico in late 2010 along with seven men, some of them suspected drug traffickers. Authorities found a large stash of weapons, ammunition and $ 53,300 with them inside a vehicle.

In 2011, a Colombian former model and pageant contestant was detained along with Jose Jorge Balderas, an accused drug trafficker and suspect in the 2010 bar shooting of Salvador Cabanas, a former star for Paraguay‘s national football team and Mexico’s Club America. She was also later released.

Higuera said Flores Gamez’s body has been turned over to relatives for burial.

“This is a sad situation,” Higuera told a local radio station. She had been enrolled in media courses at a local university, and had been modeling and in pageants since at least 2009.

Javier Valdez, the author of a 2009 book about narco ties to beauty pageants entitled “Miss Narco,” said “this is a recurrent story.”

“There is a relationship, sometimes pleasant and sometimes tragic, between organized crime and the beauty queens, the pageants, the beauty industry itself,” Valdez said.

“It is a question of privilege, power, money, but also a question of need,” said Valdez. “For a lot of these young women, it is easy to get involved with organized crime, in a country that doesn’t offer many opportunities for young people.”

Sometimes drug traffickers seek out beauty queens, but sometimes the models themselves look for narco boyfriends, Valdez said.

“I once wrote about a girl I knew of who was desperate to get a narco boyfriend,” he said. “She practically took out a classified ad saying ‘Looking for a Narco’.”

The stories seldom end well. In the best of cases, a beautiful woman with a tear-stained face is marched before the press in handcuffs. In the worst of cases, they simply disappear.

“They are disposable objects, the lowest link in the chain of criminal organizations, the young men recruited as gunmen and the pretty young women who are tossed away in two or three years, or are turned into police or killed,” Valdez said.

___

Associated Press Writer E. Eduardo Castillo contributed to this report

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India: 2 policemen suspended, magistrate transferred for arrest of 2 women over Facebook post

NEW DELHI – An Indian official says two senior policemen have been suspended for arresting two women over a Facebook post criticizing the shutdown of Mumbai for the funeral of a powerful politician.

Maharashtra state Home Minister R.R. Patil said Tuesday the policemen were suspended indefinitely and the magistrate who registered the case against the women has been transferred to another district.

Police also arrested nine men who vandalized a medical clinic run by the uncle of one of the women, Patil said.

One of the women had posted a Facebook comment complaining that Mumbai had come to a standstill after the death of rightwing leader Bal Thackeray. Her friend “liked” the post.

Their arrest last week was seen as a misuse of Internet laws and an attempt to curb freedom of expression.

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Outbreak-Tied Peanut Butter Plant Shut

Nov 26, 2012 7:37pm

The Food and Drug Administration today shut down the country’s largest organic peanut butter processor following a salmonella outbreak that sickened scores of people nationwide.

For the first time the FDA has utilized new power granted by the 2011 food safety law and shut down Sunland Inc.’s New Mexico processing plant.

In a statement on their website, the FDA said that the link between the company and the salmonella outbreak that sickened 41 people in 20 states along with “Sunland’s history of violations led FDA to make the decision to suspend the company’s registration.”

Between June 2000 and September 2012 eleven product lots of nut butter tested positive for presence of Salmonella. And, according to the FDA, between March 2010 and September 2012, Sunland Inc. distributed at least a portion of eight product lots after they had tested positive.

The FDA also found the presence of Salmonella in 28 environmental samples during a September and October 2012 inspection.  FDA inspectors reported that employees of Sunland Inc. failed to wash hands, improperly handled equipment used to process food as well as providing  ”no records” to document cleaning of equipment. Additionally, the building housing the production and packaging had no hand-washing sinks even though employees had “bare-handed contact” with the product.

“The super-sized bags used by the firm to store peanuts were not cleaned despite being used for both raw and roasted peanuts.  There was a leaking sink in a washroom which resulted in water accumulating on the floor, and the plant is not built to allow floors, walls and ceilings to be adequately cleaned.

Finally, investigators found that raw materials were exposed to potential contamination.  Raw, in-shell peanuts were found outside the plant in uncovered trailers. Birds were observed landing in the trailers and the peanuts were exposed to rain, which provides a growth environment for Salmonella and other bacteria.  Inside the warehouse, facility doors were open to the outside, which could allow pests to enter.”

In a November 15 statement the president and CEO of Sunland, Jimmie Shearer, emphasized that at “no time” did the company distribute products they knew to be contaminated. The company has submitted a response to the FDA outlining their response to the recall and contaminated product testing.

“We believe that drawing any inferences much less conclusions about the Company’s practices based solely on the observations as set forth in the Form 483 without considering the Company’s response would be wholly premature and unduly prejudicial to Sunland.”

Food Safety Modernization Act, which the FDA acted under to shut down the plant, grants the agency the authority to suspend manufacturing when there is “reasonable probability of causing serious adverse health consequences or death to humans or animals, and other conditions are met.”

Sunland Inc., can request an informal hearing to lift the suspension.  However the 24-year-old company will only have its registration returned after the FDA decides the company has safe manufacturing practices.

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Arafat's remains exhumed for poison tests

RAMALLAH, West Bank (Reuters) - Forensic experts took samples from Yasser Arafat's buried corpse in the West Bank on Tuesday, trying to determine if he was murdered by Israeli agents using the hard-to-trace radioactive poison, Polonium.

Palestinians witnessed the funeral of their hero and longtime leader eight years ago, but conspiracy theories surrounding his death have never been laid to rest.

Many are convinced their icon was the victim of a cowardly assassination, and may stay convinced whatever the outcome of this autopsy. But some in the city of Ramallah where he lies deplored the exhumation.

"This is wrong. After all this time, today they suddenly want to find out the truth?" said construction worker Ahmad Yousef, 31, who stopped to watch the disinterment, carried out behind a wall of blue plastic near the Palestinian presidency headquarters.

"They should have done it eight years ago," he said.

French magistrates in August opened a murder inquiry into Arafat's death in Paris in 2004 after a Swiss institute said it had discovered high levels of polonium on clothing of his which was supplied by his widow, Suha, for a television documentary.

"Samples will be taken according to a very strict protocol and these samples will be analyzed," said Darcy Christen, spokesman for Lausanne University Hospital in Switzerland that carried out the original tests on Arafat's clothes.

"In order to do these analyses, to check, cross-check and double cross-check, it will take several months and I don't think we'll have anything tangible available before March or April next year," he added.

Arafat was always a freedom fighter to Palestinians but a terrorist to Israelis first, and a partner for peace only later. He led the bid for a Palestinian state through years of war and peacemaking, then died in a French hospital aged 75 after a short, mysterious illness.

No autopsy was carried out at the time, at the request of Suha, and French doctors who treated him said they were unable to determine the cause of death.

But allegations of foul play immediately surfaced, and many Palestinians pointed the finger at Israel, which confined Arafat to his West Bank headquarters in Ramallah for the final two and a half years of his life after a Palestinian uprising erupted.

Israel denies murdering him. Its leader at the time, Ariel Sharon, now lies in a coma from which he is expected never to awake. Israel invited the Palestinian leadership to release all Arafat's medical records, which were never made public following his death and still have not been opened.

FRENCH INVESTIGATORS

Polonium, apparently ingested with food, was found to have caused the death of former Russian spy Alexander Litvinenko in London in 2006. But some experts have questioned whether Arafat could have died in this way, pointing to a brief recovery during his illness that they said was not consistent with radioactive poisoning. They also noted he did not lose all his hair.

Eight years is considered the limit to detect any traces of the fast-decaying polonium and Lausanne hospital questioned in August if it would be worth seeking any samples, if access to Arafat's body was delayed as late as "October or November."

Not all of Arafat's family agreed to the exhumation, and his wife Suha chose not to attend the operation she had prompted.

Working in parallel with the forensic team, French magistrates were in Ramallah this week to ask if members of Arafat's inner circle might be able to shed light on his death.

One source told Reuters the French had a list of 60 questions, and had questioned one man for five hours.

Many Palestinians acknowledge that a Palestinian would almost certainly have had to administer any poison, wittingly or unwittingly.

(Writing by Crispian Balmer; Editing by Douglas Hamilton and Tom Pfeiffer)

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