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 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 potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

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. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

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. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

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 developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail 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 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

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Wall Street rallies on growth optimism

NEW YORK (Reuters) - Stocks rose on Monday, suggesting the equity rally was intact as investors grew more confident that the global economy would continue to grow.

Stocks have been strong performers so far this year, with the S&P 500 jumping 6.2 percent in 2013 to hover around its highest levels since 2007. That has prompted many to call for a pullback, though recently any dip has been used as a buying opportunity.

While the S&P fell last week, the decline was a slight 0.3 percent and was the first weekly drop after a seven-week string of gains.

"The major trend is that indexes will keep moving higher, a reflection that the economy continues to grow at a moderate pace," said Bernard Baumohl, managing director at the Economic Outlook Group in Princeton, New Jersey.

The Dow Jones industrial average <.dji> was up 45.78 points, or 0.33 percent, at 14,046.35. The Standard & Poor's 500 Index <.spx> was up 6.90 points, or 0.46 percent, at 1,522.50. The Nasdaq Composite Index <.ixic> was up 16.87 points, or 0.53 percent, at 3,178.69.

Equities will face a test with the looming debate over sequestration, massive U.S. government budget cuts that will take effect on Friday if lawmakers fail to reach an agreement over spending and taxes. The White House issued warnings about the harm the cuts are likely to inflict on the economy if enacted.

Early results from Italy's general election cheered markets there after the pro-reform, center-left Democratic Party was leading Silvio Berlusconi's conservative bloc. [ID:nL6N0BPFBQ] Investors worried if the elections went the wrong way, efforts to handle Italy's debt problems would be undermined.

"Odds are that there will be a coalition government that will let the austerity measures stay in place, allowing yields to come down and avoiding what would have been a headwind for U.S. markets," said Baumohl.

European shares <.fteu3> rose 0.4 percent while Italy's main FTSE MIB <.ftmib> soared 3.5 percent.

The Nasdaq was lifted by a rallies at SanDisk Corp , which jumped 2.7 percent to $50.81, and Amgen Inc , up 3.8 percent to $90.16.

Barnes & Noble Inc climbed 7.8 percent to $14.56 after the Wall Street Journal reported that Chairman Leonard Riggio was considering a bid for the company's bookstore business.

Lowe's Cos Inc reported earnings that beat expectations, helped by rebuilding efforts after Hurricane Sandy in the United States. After climbing in premarket, shares dipped 0.7 percent to $37.42.

With 83 percent of the S&P 500 having reported results, 69 percent of beat profit expectations, compared with a 62 percent average since 1994 and 65 percent over the past four quarters, according to Thomson Reuters data.

Fourth-quarter earnings for S&P 500 companies are estimated to have risen 6 percent, according to the data, above a 1.9 percent forecast at the start of the earnings season.

Dynavax Technologies Inc shares plunged 34 percent to $1.96 after the Food and Drug Administration denied approval for the company's adult hepatitis B vaccine and sought additional data for evaluate its safety.

(Editing by Chizu Nomiyama and Kenneth Barry)

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IHT Rendezvous: As Oscars Fever Builds, Some Chinese Ask: ‘What About Our Films?’

BEIJING — As Oscar fever grows around the world with the 85th Academy Awards set to begin in Los Angeles just hours from now, excitement is building in China, even though it has no films in competition. There is also a sense of frustration here about why China’s movies aren’t nominated for the world’s biggest awards?

China sees itself as advancing in many ways, growing richer and more powerful, so its inability to come up with serious Oscars contenders rankles.

The most popular answer to the question, held by ordinary Chinese and film experts alike, is: “Too few good films. That’s the real reason in recent years Chinese films have moved further and further away from the Oscars dream,” wrote The International Herald Leader newspaper, in a story carried on the country’s popular Tencent entertainment site.

An article by The Economic Daily, carried on People’s Daily Web site, gave another interpretation: “The Oscars have never been a communal forum, the films taken seriously have only the responsibility to portray the North American world view and the lives they’re willing to see.”

As I’ve explored elsewhere, strict censorship hobbles the Chinese film industry. Directors are increasingly voicing their frustration in public, yet there’s little they can do against the directives of the state. One result of this hamstringing of talent is it’s virtually impossible to make probing films about contemporary society, which has many social tensions the government doesn’t want openly explored. Instead, filmmakers retreat to the safety of historical themes, with tales of warring dynasties commonplace.

Also, strict import rules governing overseas movies mean few may be shown here. As a person with the handle LA-YIN wrote on Sina Weibo, the microblog: “With the exception of Ang Lee’s ‘Life of Pi,’ none of the nominated films has screened in China.”

Much attention is being focused on a prediction of winners in an annual list drawn up by the actress Zhang Ziyi. Ms. Zhang starred in “Crouching Tiger, Hidden Dragon,” a hit in 2000 by the Taiwanese director Ang Lee. She is also the first Chinese star from the People’s Republic of China to be listed on the jury for the Oscars, in 2005, Xinhua, the state news agency, reported.

Many netizens are pointing out that Ms. Zhang’s list runs at an estimated 90 percent accuracy rate. So what’s she tapping?

Best Director? Mr. Lee and Steven Spielberg (“Lincoln”) are in tight competition, she writes. “Emotionally, I’m drawn to Ang Lee. Intellectually I’m drawn to Spielberg. These are the two films I’ve liked most this year.”

Best Film? “Lincoln. Whether you like the movie or not, it gives off glamor and radiance. I salute Spielberg’s youthfulness,” she wrote.

China is 16 hours ahead of Los Angeles, so watching will be tricky for people headed into a normal working day on Monday. As –Mostro- wrote on a microblog site, “It’s the Oscars today!!!!!!! But it’ll only be on tomorrow, Beijing time ….I can’t watch it,” followed by four yellow, grimacing emoticons.

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You're Invited to PEOPLE.com's Oscars Party!

02/24/2013 at 08:40 AM EST

From left: Bradley Cooper, Oscar, Jessica Chastain

AFP/Getty; Wireimage; Splash News Online

Oscars host Seth MacFarlane isn't the only one gearing up for Hollywood's biggest night – we are too!

Be a part of the glamour and excitement Sunday starting at 6 p.m. ET/3 p.m. PT when we roll out the red carpet for our PEOPLE.com VIPs.

Here's what you can expect:
• Tune in to our live red carpet preshow for exclusive A-list interviews
• Be the first to see the gorgeous gowns – and make your own best-dressed list
• Download your own play-along ballot – and vote on your Academy Awards picks
• Tweet with our editors at #PeopleOscars, and watch the conversation on our homepage. We'll be joined by DKNY PR Girl (@dkny), model Coco Rocha (@cocorocha), the hilarious Go Fug Yourself (@fuggirls), @WhoWhatWear and blogger @Possessionista!
• Take our up-to-the-minute Oscars polls

And come back the next day for so much more ...
• See the night's best dresses from all angles with our 360º slideshow
• Come inside the most exclusive Oscars after-parties
• Relive the most memorable quotes of the show
• Get the scoop on the night's biggest shockers and funniest moments everyone is talking about

We're looking forward to a fun, fashion-filled night – see you then!

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U.N. Rejects Claim for Direct Compensation to Victims of Cholera Epidemic in Haiti

There will be no direct financial compensation from the United Nations for the more than 8,000 Haitians who died and the 646,000 sickened by cholera since the disease struck the earthquake-ravaged country in October 2010, Secretary General Ban Ki-moon told the Haitian president this week.

More than 15 months after the United Nations received a legal claim seeking to hold peacekeeping troops responsible for setting off the epidemic, its lawyers declared the claim “not receivable,” citing diplomatic immunity.

At the same time, Partners in Health, the leading nongovernmental health care provider in Haiti, has stepped forward to urge the United Nations to invest more seriously in Mr. Ban’s own largely unfunded anticholera initiative to make amends.

In an Op-Ed article posted Friday night on the Web site of The New York Times, Dr. Louise C. Ivers, the group’s senior health and policy adviser, says the United Nations has “a moral, if not legal, obligation to help solve a crisis it inadvertently helped start.” Evidence, she said, finds the United Nations “largely, though not wholly” culpable for the outbreak of cholera.

To date, Mr. Ban has not acknowledged the reigning scientific theory about the origin of Haiti’s cholera epidemic — that peacekeepers from Nepal imported the cholera and, through a faulty sanitation system at their base, infected a tributary of the country’s largest river.

Dr. Ivers, however, while noting the “causality” of epidemic disease is complex, says that no other reasonable hypothesis for Haiti’s cholera has been put forth.

What makes her comments especially striking is that her organization’s co-founder and chief strategist, Dr. Paul Farmer, served as the United Nations’ deputy special envoy for Haiti for the past three years and was appointed by Mr. Ban in December to lead the very anticholera initiative that she found lacking.

Dr. Farmer declined to comment, but a spokeswoman for Partners in Health said Dr. Ivers’s statements represented the group’s concerns about the 10-year, $2.2 billion anticholera initiative that he was supposed to advise.

The ambitious initiative is intended to upgrade Haiti’s abysmal water and sanitation infrastructure while increasing cholera prevention and treatment efforts, including the expansion of a small cholera vaccination campaign that Partners in Health and a Haitian health care group, Gheskio, undertook last year.

Donors have pledged $215 million. The United Nations said it would contribute $23.5 million — 1 percent of the initiative’s cost, Dr. Ivers said.

In contrast, she said, this year’s budget for the United Nations peacekeeping mission, $648 million, “could more than fund the entire cholera elimination initiative for two years.”

Expressing his “deep sorrow and solidarity with the many Haitian families who lost loved ones in this terrible epidemic,” Nigel Fisher, the new head of the peacekeeping mission, nonetheless said that the United Nations had “mobilized resolutely to combat the disease.” It spent some $118 million on cholera before the initiative was announced, officials have said.

Mr. Ban, through his spokesman, also expressed “his profound sympathy” while announcing on Thursday that the legal claim had been rejected.

Mario Joseph, lead lawyer for the cholera victims, said, “While these sympathies are welcome, they will not stop cholera’s killing or ensure that survivors can go on living after losing breadwinners to cholera.”

The demand, filed in an internal United Nations claims unit, had sought $100,000 for each bereaved family and $50,000 for each cholera survivor.

Mr. Joseph described the United Nations’ terse rejection of a claim filed over a year ago as “disgraceful,” and he and his American colleagues at the Institute for Justice and Democracy in Haiti said they would file a lawsuit in Haiti or abroad.

Though the death rate from cholera has declined significantly since the epidemic initially devastated Haiti, the disease is still coursing through the country. National statistics show a spike of reported cases in December 2012 over that same month in 2011 — 11,220 compared with 8,205.

“The U.N. will not pay,” said a headline Friday on the Web site of Haiti’s Le Nouvelliste newspaper.

“It’s not surprising,” a reader responded.

This article has been revised to reflect the following correction:

Correction: February 23, 2013

An earlier version of this article misrendered a quotation from an Op-Ed article by Dr. Louise C. Ivers. The quotation should have read “largely, though not wholly,” not “largely, if not wholly.”

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Reeva Steenkamp's Father: If Oscar Pistorius Speaks the Truth, 'I Can Perhaps Someday Forgive Him'

By Stephen M. Silverman

02/23/2013 at 09:30 AM EST

Oscar Pistorius and Reeva Steenkamp

Elite/EMPICS Entertainment/ABACA

Having been freed on bail Friday as he awaits trial for the premeditated murder of his girlfriend Reeva Steenkamp, Oscar Pistorius "will have to live with his conscience," her father said Saturday.

Speaking to the Beeld newspaper (and translated by the BBC), Barry Steenkamp – referring to Pistorius's claim that he fatally fired his gun four times at Reeva because he thought an intruder had broken into his house – said: "If it didn't happen the way he says it did, he must suffer and he will suffer."

Steenkamp also said, "It does not matter how much money he has and how good his legal team is, he will have to live with his conscience. But if he speaks the truth, I can perhaps someday forgive him."

The next hearing for the Paralympian, 26, is scheduled for June 4.

Besides setting bail at $114,000 – the amount is considered high for a murder trial in South Africa, reports The New York Times – Magistrate Nair Desmond also ordered Pistorius to relinquish firearms and passports, and to stay away from his home, because it is an official crime scene.

In addition, he is not permitted to contact witnesses, leave Pretoria without official permission or use drugs or alcohol. He is to report to a police station twice every week.

Arnold Pistorius, an uncle speaking on behalf of the family, told reporters Friday, "We are relieved by the fact that Oscar got bail today, but at the same time, we are in mourning for Reeva Steenkamp and her family."

Oscar Pistorius is reportedly staying at Arnold's home in an upscale part of Pretoria. News photos showed the athlete being picked up from the courtroom and driven away by his sister, Aimee.

Reeva Steenkamp's mother June told Beeld that the Pistorius family had sent a bouquet of flowers.

"But what does it mean?" she said. "Nothing."

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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 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 potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

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. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

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. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

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 developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail 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 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

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Investors face another Washington deadline

NEW YORK (Reuters) - Investors face another Washington-imposed deadline on government spending cuts next week, but it's not generating the same level of fear as two months ago when the "fiscal cliff" loomed large.

Investors in sectors most likely to be affected by the cuts, like defense, seem untroubled that the budget talks could send stocks tumbling.

Talks on the U.S. budget crisis began again this week leading up to the March 1 deadline for the so-called sequestration when $85 billion in automatic federal spending cuts are scheduled to take effect.

"It's at this point a political hot button in Washington but a very low level investor concern," said Fred Dickson, chief market strategist at D.A. Davidson & Co. in Lake Oswego, Oregon. The fight pits President Barack Obama and fellow Democrats against congressional Republicans.

Stocks rallied in early January after a compromise temporarily avoided the fiscal cliff, and the Standard & Poor's 500 index <.spx> has risen 6.3 percent since the start of the year.

But the benchmark index lost steam this week, posting its first week of losses since the start of the year. Minutes on Wednesday from the last Federal Reserve meeting, which suggested the central bank may slow or stop its stimulus policy sooner than expected, provided the catalyst.

National elections in Italy on Sunday and Monday could also add to investor concern. Most investors expect a government headed by Pier Luigi Bersani to win and continue with reforms to tackle Italy's debt problems. However, a resurgence by former leader Silvio Berlusconi has raised doubts.

"Europe has been in the last six months less of a topic for the stock market, but the problems haven't gone away. This may bring back investor attention to that," said Kim Forrest, senior equity research analyst at Fort Pitt Capital Group in Pittsburgh.

OPTIONS BULLS TARGET GAINS

The spending cuts, if they go ahead, could hit the defense industry particularly hard.

Yet in the options market, bulls were targeting gains in Lockheed Martin Corp , the Pentagon's biggest supplier.

Calls on the stock far outpaced puts, suggesting that many investors anticipate the stock to move higher. Overall options volume on the stock was 2.8 times the daily average with 17,000 calls and 3,360 puts traded, according to options analytics firm Trade Alert.

"The upside call buying in Lockheed solidifies the idea that option investors are not pricing in a lot of downside risk in most defense stocks from the likely impact of sequestration," said Jared Woodard, a founder of research and advisory firm condoroptions.com in Forest, Virginia.

The stock ended up 0.6 percent at $88.12 on Friday.

If lawmakers fail to reach an agreement on reducing the U.S. budget deficit in the next few days, a sequester would include significant cuts in defense spending. Companies such as General Dynamics Corp and Smith & Wesson Holding Corp could be affected.

General Dynamics Corp shares rose 1.2 percent to $67.32 and Smith & Wesson added 4.6 percent to $9.18 on Friday.

EYES ON GDP DATA, APPLE

The latest data on fourth-quarter U.S. gross domestic product is expected on Thursday, and some analysts predict an upward revision following trade data that showed America's deficit shrank in December to its narrowest in nearly three years.

U.S. GDP unexpectedly contracted in the fourth quarter, according to an earlier government estimate, but analysts said there was no reason for panic, given that consumer spending and business investment picked up.

Investors will be looking for any hints of changes in the Fed's policy of monetary easing when Fed Chairman Ben Bernake speaks before congressional committees on Tuesday and Wednesday.

Shares of Apple will be watched closely next week when the company's annual stockholders' meeting is held.

On Friday, a U.S. judge handed outspoken hedge fund manager David Einhorn a victory in his battle with the iPhone maker, blocking the company from moving forward with a shareholder vote on a controversial proposal to limit the company's ability to issue preferred stock.

(Additional reporting by Doris Frankel; Editing by Kenneth Barry)

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BBC Leaders Have Harsh Words for Own Corporation

LONDON (AP) — The BBC is a bloated, top-heavy, and poorly-led corporation staffed by dull executives — and that's just what the company's leadership says.

In 3,000 pages of emails and interviews published Friday, the BBC's top officials have harsh words for the institutional culture of their respected media group, whose reputation has been tarnished by a pedophilia scandal.

Leading BBC presenter Jeremy Paxman says it has recruited many people "who are clearly not the most creative." BBC Trust Chairman Chris Patten says the organization once had "more senior leaders than China."

The comments are contained in the BBC's probe of its handling of sex crime allegations against the late entertainer Jimmy Savile. It concluded that chaos and miscommunication were to blame for a bungled response to the sex abuse revelations.

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Music Mogul Clive Davis: My Lucky Life

By Kevin O'Donnell

02/22/2013 at 10:00 AM EST

On a late January afternoon, Clive Davis is sitting in his wood-paneled office in Sony Music's Manhattan headquarters. Soon he'll be off to catch the opening night of his pal Barry Manilow's new Broadway show.

But right now he's gazing at his wall, which holds photos of him with just about every superstar musician through the years: Whitney Houston, Alicia Keys, Aretha Franklin.

Growing up in Brooklyn in the '30s and '40s, the legendary music mogul, now 80, was never obsessed with music – "My charts were baseball charts!" – and today sometimes even he can't believe his enormous success. "Luck played a part," he says.

Luck and a phenomenal gift for recognizing, nurturing and selling talent. In his new memoir, The Soundtrack of My Life, the five-time Grammy-winning Hall of Famer reflects on his nearly five decades as a record producer and executive, discovering and guiding performers like Houston and Alicia Keys, overseeing the careers of, at one time, Barbra Streisand and Bob Dylan and helping Santana make a huge comeback in 1999.

"The breadth of styles he can bring to the top – no one can touch that," says Bill Werde, Billboard's editorial director. "Clive deeply feels the music."

His memoir also pulls back the curtain on his personal life. Though married twice and father to four grown children, he reveals that he is bisexual and that his current relationship is with a man.

Though he says he never hid his sexual orientation from those closest to him, he's telling the rest of the world in his book because "this is the story of my life," he says. "I knew I was going to include that important part of it."

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