FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla (kad-SY'-luh) from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a double-shot of anti-tumor poison.

Cancer researchers say the drug may offer a clear advantage over older drugs because it delivers more medication with fewer side effects.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug.

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was co-developed by South San Francisco-based Genentech and ImmunoGen Inc., of Waltham, Mass. ImmunoGen developed the technology that binds the drug ingredients together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 33 cents, or 2.27 percent, to $14.63 in midday trading.

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The Duggars Visit Asia on Upcoming TLC Special: Catch a Sneak Peek

TV Watch

By Tim Nudd

02/21/2013 at 12:50 PM EST

Kids, we're not in Arkansas anymore.

One of America's most populous family, the Duggars, visit the world's most populous country, China, as part of a longer trip to Asia captured in a three-episode special coming to TLC in March.

Getting 25 Duggars and their 40 suitcases to the airport is a struggle all its own. But then they tour Japan and China, where the familiar logistical challenges are compounded by the cultural differences.

Their adventures find them experimenting with local food, riding Rickshaws, donning traditional Geisha dress and fighting as Samurai warriors.

In Beijing, they finally negotiate the subway and get to Tiananmen Square, only to find themselves to be something of a tourist attraction in their own right.

19 Kids and Counting: Duggars Do Asia will air on TLC on March 12, 19 and 26 at 9ET/PT.

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Flu shot did poor job against worst bug in seniors

ATLANTA (AP) — For those 65 and older, this season's flu shot is only 9 percent effective against the most common and dangerous flu bug, according to a startling new government report.

Flu vaccine tends to protect younger people better than older ones and never works as well as other kinds of vaccines. But experts say the preliminary results for seniors are disappointing and highlight the need for a better vaccine.

For all age groups, the vaccine's effectiveness is moderate at 56 percent, which is nearly as well as other flu seasons, the Centers for Disease Control and Prevention said Thursday.

For those 65 and older, it is 27 percent effective against the three strains in the vaccine, the lowest in about a decade but not far below from what's expected. But the vaccine did a particularly poor job of protecting older people against the harshest flu strain, which is causing most of the illnesses this year. CDC officials say it's not clear why.

Vaccinations are now recommended for anyone over 6 months, and health officials stress that some vaccine protection is better than none at all. While it's likely that older people who were vaccinated are still getting sick, many of them may be getting less severe symptoms.

"Year in and year out, the vaccine is the best protection we have," said CDC flu expert Dr. Joseph Bresee.

To be sure, the preliminary data for seniors is less than definitive. It is based on fewer than 300 people scattered among five states.

But it will no doubt surprise many people that the effectiveness is that low, said Michael Osterholm, a University of Minnesota infectious disease expert who has tried to draw attention to the need for a more effective flu vaccine.

Among infectious diseases, flu is considered one of the nation's leading killers. On average, about 24,000 Americans die each flu season, according to the CDC.

This flu season started in early December, a month earlier than usual, and peaked by the end of year. Older people are most vulnerable to flu and its complications, and the nation has seen some of the highest hospitalization rates for people 65 and older in a decade.

Flu viruses tend to mutate more quickly than others, and it's not unusual for multiple strains to be spreading at the same time. A new vaccine is formulated each year targeting the three strains expected to be the major threats. But that involves guesswork.

Because of these challenges, scientists tend to set a lower bar for flu vaccine. While childhood vaccines against diseases like measles are expected to be 90 or 95 percent effective, a flu vaccine that's 60 to 70 percent effective in the U.S. is considered pretty good.

By that standard, this year's vaccine is OK. The 56 percent effectiveness figure means people have a 56 percent lower chance of winding up at the doctor for treatment of flu symptoms.

For seniors, a flu vaccine is considered pretty good if it's in the 30 to 40 percent range, said Dr. Arnold Monto, a University of Michigan flu expert.

Older people have weaker immune systems that don't respond as well to flu shots. That's why a high-dose version was recently made available for those 65 and older. The new study was too small to show whether that made a difference this year.

The CDC estimates are based on about 2,700 people who got sick in December and January. The researchers traced back to see who had gotten flu shots and who hadn't. An earlier study put the vaccine's overall effectiveness slightly higher, at 62 percent.

The CDC's Bresee said there's a danger in providing preliminary results because it may result in people doubting — or skipping — flu shots. But the data was released to warn older people who got shots that they may still get sick and shouldn't ignore any serious flu-like symptoms, he said.

The new data highlights an evolution in how experts are evaluating flu vaccine effectiveness. For years, it was believed that if the viruses in the vaccine matched the ones spreading around the country, then the vaccine would be effective. This year's shot was a good match to the bugs going around this winter, including the harsher H3N2 that tends to make people sicker.

But the season proved to be a moderately severe one, with many illnesses occurring in people who'd been vaccinated.

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Online:

CDC report: http://www.cdc.gov/mmwr

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Wall Street extends losses, Nasdaq down 1 percent

DEAR ABBY: My boyfriend, "Doug" (24), and I (22) have been in a long-distance relationship for a year, but we were friends for a couple of years before that. I had never had a serious relationship before and lacked experience. Doug has not only been in two other long-term relationships, but has had sex with more than 15 women. One of them is an amateur porn actress.I knew about this, but it didn't bother me until recently. Doug had a party, and while he was drunk he told one of his buddies -- in front of me -- that he should watch a certain porn film starring his ex-girlfriend. ...

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Bulgarian government resigns amid growing protests

SOFIA (Reuters) - Bulgaria's government resigned on Wednesday after mass protests against high power prices and falling living standards, joining a long list of European administrations felled by austerity during four years of debt crisis.

Prime Minister Boiko Borisov, an ex-bodyguard who took power in 2009 on pledges to root out graft and raise incomes in the European Union's poorest member, faces a tough task of propping up eroding support ahead of an expected early election.

Wage and pension freezes and tax hikes have bitten deep in a country where earnings are less than half the EU average and tens of thousands of Bulgarians have rallied in protests that have turned violent, chanting "Mafia" and "Resign".

Moves by Borisov on Tuesday to blame foreign utility companies for the rise in the cost of heating homes was to no avail and an eleventh day of marches saw 15 people hospitalized and 25 arrested in clashes with police.

"My decision to resign will not be changed under any circumstances. I do not build roads so that blood is shed on them," said Borisov, who began his career guarding the Black Sea state's communist dictator Todor Zhivkov.

A karate black belt, Borisov has cultivated a Putin-like "can-do" image since he entered politics as Sofia mayor in 2005 and would connect with voters by showing up on the capital's rutted streets to oversee the repair of pot-holes.

But critics say he has often skirted due process, sometimes to the benefit of those close to him, and his swift policy U-turns have wounded the public's trust.

The spark for the protests was high electricity bills, after the government raised prices by 13 percent last July. But it quickly spilled over into wider frustration with Borisov and political elites with perceived links to shadowy businesses.

"He made my day," said student Borislav Hadzhiev in central Sofia, commenting on Borisov's resignation. "The truth is that we're living in an extremely poor country."

POLLS, PRICES

The prime minister's final desperate moves on Tuesday included cutting power prices and risking a diplomatic row with the Czech Republic by punishing companies including CEZ, moves which conflicted with EU norms on protection of investors and due process.

CEZ officials were hopeful on Wednesday that it would be able to avoid losing its distribution license after all and officials from the Bulgarian regulator said the company would not be punished if it dealt with breaches of procedure.

But shares in what is central Europe's largest publicly-listed company fell another 1 percent on Wednesday.

If pushed through, the fines for CEZ and two other foreign-owned firms will not encourage other investors in Bulgaria, who already have to navigate complicated bureaucracy and widespread corruption and organized crime to take advantage of Bulgaria's 10-percent flat tax rate.

Financial markets reacted negatively to the turbulence on Wednesday. The cost of insuring Bulgaria's debt rose to a three-month high and debt yields rose some 15 basis points, though the country's low deficit of 0.5 percent of gross domestic product means there is little risk to the lev currency's peg against the euro.

Borisov's interior minister indicated that elections originally planned for July would probably be pulled forward by saying that his rightist GERB party would not take part in talks to form a new government.

MILLIONS GONE

GERB's woes have echoes in another ex-communist EU member, Slovenia, where demonstrators have taken to the streets and added pressure to a crumbling conservative government.

A small crowd gathered in support of Borisov outside Sofia's parliament, which is expected to approve his resignation on Thursday, while bigger demonstrations against the premier were expected in the evening.

Unemployment in the country of 7.3 million is far from the highs hit in the decade after the end of communism but remains at 11.9 percent. Average salaries are stuck at around 800 levs ($550) a month and millions have emigrated, leaving swathes of the country depopulated and little hope for those who remain.

GERB's popularity has held up well and it still led in the latest polls before protests grew in size last weekend, but analysts say the opposition Socialists should draw strength from the demonstrations.

The leftists, successors to Bulgaria's communist party, have proposed tax cuts and wage hikes and are likely to raise questions about public finances if elected.

(Additional reporting by Angel Krasimirov; editing by Patrick Graham)

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Sean Lowe: Tierra Made Me Feel Like 'Such a Fool'

TV Watch

The Bachelor

02/20/2013 at 12:15 PM EST

Sean Lowe and Tierra on The Bachelor

No regrets? Not so fast.

In his PEOPLE.com blog, The Bachelor's Sean Lowe has written about how he never saw Tierra LiCausi behaving badly – despite what the other women told him about the controversial contestant, who is now engaged.

But after watching, Sean realized the women were right.

"Man, I was such a fool," Sean, told host Chris Harrison on Sean Tells All special Tuesday night. "I really do feel like I was duped."

In fact, Sean, 28, who had an immediate connection with Tierra, says he never should have met her that first night.

"Tierra never should have come on this show. She's not suited for this show," he said. "She doesn't know how to handle herself in this environment. She's a woman who ... simply can't get along with her peers."

Not only did Tierra waste his time, Sean says, he witnessed her "getting into arguments and fights with the sweetest, best people in the house."

But no one may be more upset about Tierra than the women who was sent home instead of Tierra, Jackie Parr, on a two-on-one date in Montana.

I wouldn't have kept [Tierra]," Sean said on Tuesday's special. "I wish I would have kept Jackie on the two-on-one."

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Drug overdose deaths up for 11th consecutive year

CHICAGO (AP) — Drug overdose deaths rose for the 11th straight year, federal data show, and most of them were accidents involving addictive painkillers despite growing attention to risks from these medicines.

"The big picture is that this is a big problem that has gotten much worse quickly," said Dr. Thomas Frieden, head of the Centers for Disease Control and Prevention, which gathered and analyzed the data.

In 2010, the CDC reported, there were 38,329 drug overdose deaths nationwide. Medicines, mostly prescription drugs, were involved in nearly 60 percent of overdose deaths that year, overshadowing deaths from illicit narcotics.

The report appears in Tuesday's Journal of the American Medical Association.

It details which drugs were at play in most of the fatalities. As in previous recent years, opioid drugs — which include OxyContin and Vicodin — were the biggest problem, contributing to 3 out of 4 medication overdose deaths.

Frieden said many doctors and patients don't realize how addictive these drugs can be, and that they're too often prescribed for pain that can be managed with less risky drugs.

They're useful for cancer, "but if you've got terrible back pain or terrible migraines," using these addictive drugs can be dangerous, he said.

Medication-related deaths accounted for 22,134 of the drug overdose deaths in 2010.

Anti-anxiety drugs including Valium were among common causes of medication-related deaths, involved in almost 30 percent of them. Among the medication-related deaths, 17 percent were suicides.

The report's data came from death certificates, which aren't always clear on whether a death was a suicide or a tragic attempt at getting high. But it does seem like most serious painkiller overdoses were accidental, said Dr. Rich Zane, chair of emergency medicine at the University of Colorado School of Medicine.

The study's findings are no surprise, he added. "The results are consistent with what we experience" in ERs, he said, adding that the statistics no doubt have gotten worse since 2010.

Some experts believe these deaths will level off. "Right now, there's a general belief that because these are pharmaceutical drugs, they're safer than street drugs like heroin," said Don Des Jarlais, director of the chemical dependency institute at New York City's Beth Israel Medical Center.

"But at some point, people using these drugs are going to become more aware of the dangers," he said.

Frieden said the data show a need for more prescription drug monitoring programs at the state level, and more laws shutting down "pill mills" — doctor offices and pharmacies that over-prescribe addictive medicines.

Last month, a federal panel of drug safety specialists recommended that Vicodin and dozens of other medicines be subjected to the same restrictions as other narcotic drugs like oxycodone and morphine. Meanwhile, more and more hospitals have been establishing tougher restrictions on painkiller prescriptions and refills.

One example: The University of Colorado Hospital in Aurora is considering a rule that would ban emergency doctors from prescribing more medicine for patients who say they lost their pain meds, Zane said.

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Stobbe reported from Atlanta.

___

Online:

JAMA: http://www.jama.ama-assn.org

CDC: http://www.cdc.gov

___

AP Medical Writer Lindsey Tanner can be reached at http://www.twitter.com

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Wall Street dips after rally, energy shares weaker

NEW YORK (Reuters) - Stocks dipped on Wednesday, with energy shares falling as investors found few reasons to buy following a rally that has held major indexes near five-year highs for three weeks.

In addition, investors waited for the minutes from the Federal Open Market Committee's January meeting due at 2 p.m. (1900 GMT) for clues to the interest rate outlook.

Traders said there were unconfirmed rumors in the market that a troubled hedge fund was selling assets.

"I heard the chatter about a hedge fund liquidating things today but how big, I don't know. Certainly it sparks concern," said Michael James, senior trader at Wedbush Morgan in Los Angeles.

A jump in January of permits for future home building offered hope the housing market's recovery remains on track. A separate report showed wholesale prices rose last month for the first time in four months.

The S&P 500 has jumped about 7 percent so far this year, and is on track for its eighth straight week of gains. However, many of those weekly gains have been slight, with equities trading within a narrow range for the past few weeks, suggesting valuations may be stretched at current levels.

"The market seems very tired and listless, and investors are prone to take profits now as they wait for the music to stop," said Matt McCormick, money manager at Bahl & Gaynor in Cincinnati.

Energy companies were among the weakest, hurt by disappointing corporate results and a 2.4 percent drop in crude oil prices.

Newfield Exploration fell 5.8 percent to $25.73 while Devon Energy Corp fell 1.6 percent to $59.60. Both companies posted fourth-quarter losses, with Devon hurt as it wrote down the value of its assets by $896 million due to weak natural gas prices.

Groundbreaking to build new U.S. homes fell 8.5 percent in January but new permits for construction rose to a 4 1/2-year high while producer prices rose in January for the first time in four months.

Investors will look to the minutes from the Fed's January meeting for any indication as to how long the Fed will keep buying $85 billion in bonds each month to bolster U.S. employment. Economic data should enable the Fed to maintain its easy monetary policy.

The Dow Jones industrial average <.dji> dropped 16.03 points, or 0.11 percent, to 14,019.64. The Standard & Poor's 500 Index <.spx> dropped 5.81 points, or 0.38 percent, to 1,525.13. The Nasdaq Composite Index <.ixic> dropped 13.82 points, or 0.43 percent, to 3,199.77.

Shares of OfficeMax Inc fell 3.8 percent to $12.51 while Office Depot slumped 13 percent to $4.37 as the companies announced a $1.2 billion merger agreement. The shares had risen sharply earlier this week after a source said a deal would be announced. Rival Staples Inc fell 3.5 percent.

Toll Brothers Inc lost 4 percent to $35.43 after the largest luxury homebuilder in the United States, reported first-quarter results well below analysts' estimates.

The stock is up 9 percent so far this year, building on jump of nearly 60 percent in 2012.

"Valuations appear a bit high at these levels, and if I was in a name that had seen a huge run, I'd want to take some chips off the table," said McCormick, who helps oversee about $8.2 billion in assets.

SodaStream dropped 6.5 percent to $49.04 after the seller of home carbonated drink maker machines posted fourth-quarter earnings and provided a 2013 outlook.

According to Thomson Reuters data through Tuesday morning, of the 405 companies in the S&P 500 that have reported results, 71 percent have exceeded analysts' expectations, compared with a 62 percent average since 1994 and 65 percent over the past four quarters.

Fourth-quarter earnings for S&P 500 companies are estimated to have risen 5.7 percent, according to the data, above a 1.9 percent forecast at the start of the earnings season.

(Editing by Kenneth Barry)

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Venezuela's Maduro would win vote if Chavez goes: poll

CARACAS (Reuters) - Venezuelan Vice President Nicolas Maduro would win a presidential vote should his boss Hugo Chavez's cancer force him out, according to the first survey this year on such a scenario in the South American OPEC nation.

Local pollster Hinterlaces gave Maduro 50 percent of potential votes, compared to 36 percent for opposition leader Henrique Capriles.

Chavez made a surprise return to Venezuela on Monday, more than two months after cancer surgery in Cuba, to continue treatment at home for the disease that is jeopardizing his 14-year socialist rule.

He has named Maduro, 50, a former bus driver and union activist, as his preferred successor.

Capriles, 40, a center-left state governor who lost to Chavez in a presidential vote last year, likely would run again.

Chavez still has not spoken in public since his December 11 operation in Cuba. Venezuelans were debating on Tuesday the various possible scenarios after his homecoming - from full recovery to resignation or even death from the cancer.

There was widespread expectation Chavez would soon be formally sworn in for his new six-year term at the Caracas military hospital where officials said he was staying. The January 10 ceremony was postponed while he was in Cuba.

"The president's timeline is strictly linked to his medical evolution and recovery," said Rodrigo Cabezas, a senior member of Chavez's ruling Socialist Party who, like other officials, would not comment on when he might be sworn in.

CAPRILES ANGRY

Should Chavez be forced out, Venezuela's constitution stipulates an election must be held within 30 days, giving Capriles and the opposition Democratic Unity coalition another chance to end the socialists' lengthy grip on power.

Capriles, who crossed swords with Hinterlaces at various points during the presidential election, again accused its director, Oscar Schemel, of bias in the latest survey.

"That man is not a pollster, he's on the government's payroll," Capriles told local TV.

"He said in December I would lose the Miranda governorship," he added, referring to his defeat of government heavyweight Elias Jaua, now foreign minister, in that local race.

Opinion surveys are notoriously controversial and divergent in Venezuela, with both sides routinely accusing pollsters of being in the pocket of the other. But Hinterlaces successfully forecast Chavez's win with 55 percent of the vote in October.

Its latest poll was of 1,230 people between January 30-February 9.

Polls last year showed Capriles - an energetic basketball-playing lawyer who admires Brazil's centrist mix of free-market economics with strong social welfare policies - as more popular than any of Chavez's senior allies.

But Chavez's personal blessing of Maduro, on the eve of his last cancer surgery, has transformed his status and made him the heir apparent for many of the president's supporters.

As de facto leader since mid-December, Maduro also has built up a stronger public profile, copying the president's techniques of endless live TV appearances, especially to inaugurate new public works or promote popular policies like subsidized food.

He lacks Chavez's charisma, however, and opponents have slammed him as a "poor imitation" and incompetent.

EMOTION

Local analyst Luis Vicente Leon said that should Chavez die, Maduro would benefit from the emotion unleashed among his millions of passionate supporters in Venezuela.

"The funeral wake for Chavez would merge into the election campaign," he told a local newspaper, noting how Argentine President Cristina Fernandez's popularity surged when her husband and predecessor Nestor Kirchner died in 2010.

Maduro already has implemented an unpopular devaluation of the local currency and said more economic measures are coming this week in what local economists view as austerity measures after blowout spending prior to last year's election.

In Caracas, the streets were quieter after tumultuous celebrations of Chavez's homecoming by supporters on Monday. A few journalists stood outside the military hospital.

Prayer vigils were planned in various parts of Venezuela.

"We hope Chavez will stay governing because he is a strong man," supporter Cristina Salcedo, 50, said in Caracas.

Student demonstrators who had chained themselves near the Cuban Embassy last week, demanding more information on Chavez's condition, called off their protest after his return.

Until photos were published of him on Friday, the president had not been seen by the public since his six-hour December 11 operation, the fourth since cancer was detected in mid-2011.

The government has said Chavez is breathing through a tracheal tube and struggling to speak.

Bolivian President Evo Morales arrived in Caracas on Tuesday in the hope of visiting his friend and fellow leftist.

(Additional reporting by Deisy Buitrago, Mario Naranjo, Girish Gupta in Caracas, Carlos Quiroga in La Paz; Editing by Bill Trott)

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Serve Up Dinner Straight from the South Beach Wine & Food Festival

02/19/2013 at 12:05 PM EST

Carrot Lemon Thyme Sorbet and Executive Chef Hector Morales's Gazpacho

Come Thursday, there will be plenty of familiar faces heating up Miami Beach. And we mean in the kitchen.

As celeb chefs such as Bobby Flay, Paula Deen and Rachael Ray flock to the South Beach Wine & Food Festival presented by FOOD & WINE, you, too, can get a taste of the festivities, which run through the weekend. And you don't even have to leave your kitchen – just follow these recipes.

Carrot Lemon Thyme Sorbet

From Restaurant: Impossible chef Robert Irvine, who will be serving up his sorbet at the Whole Foods Market Grand Tasting Village

• 1 tbsp. lemon zest
• 1 cup carrot juice
• 1 cup water
• ¾ cup granulated sugar
• 1 tsp. thyme (minced)
• 1 cup fresh lemon juice
• ¾ cup sparkling water
Over medium high heat, bring water, juice, lemon zest, mint and sugar to a boil. Once boiling, reduce heat to medium, and simmer for additional 10 minutes. Then remove from heat and pour through chamois; let cool. Next, in a bowl, add prepared syrup and sparkling water. Finish in an ice cream machine.

Executive Chef Hector Morales's Gazpacho

Grab a cup from Badia Spices

• 4 large beefsteak tomatoes
• 1 pint orange juice
• 1 pint tomato juice
• 3 red peppers (cleaned, seeded and chopped)
• 1 green pepper (cleaned, seeded and chopped)
• 1 large cucumber (peeled and seeded, cut in cubes)
• 1 medium onion (peeled and diced)
• 2 cloves garlic (roasted and chopped; rub with olive oil before roasting)
• 2 pieces of celery (chopped)
• 2 tsp. sea salt (recipe recommends Badia's)
• ¾ cup extra-virgin olive oil (recipe recommends Badia's)
• ¼ cup apple cider vinegar
• cayenne pepper to taste
Rub tomatoes with extra-virgin olive oil, and sprinkle with sea salt. Roast in a 400ºF oven until skin starts to come off. Let cool and peel the skins; chop the tomatoes.

Mix all ingredients together in a blender and purée until smooth.

Chef Curtis Stone's Cocktail

Chef Curtis Stone's Cocktail

The Aussie chef will host Moët Hennessy's The Q After Dark at the fest

• 2 oz. vodka (recipe recommends Belvedere)
• ¾ oz. fresh lemon juice
• ¾ oz. simple syrup
Shake and strain over cubed ice into a rocks glass. Garnish with a wedge of lemon.

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