Merck KGaA cancer drug Stimuvax fails late-stage trial






FRANKFURT (Reuters) – German drugmaker Merck KGaA‘s cancer vaccine Stimuvax has failed to meet its goal of improving the survival of lung cancer patients in a late-stage trial.


“It is disappointing that the… trial did not meet its primary endpoint, in particular for patients suffering from NSCLC (non-small cell lung cancer),” the trial’s coordinating investigator, Frances Shepherd, said in a statement on Wednesday.






The trial was testing Stimuvax on more than 1,500 patients with stage III non-small cell lung cancer whose tumors could not be completely removed via surgery and whose disease had at least stabilized following chemoradiotherapy.


Merck shares fell 3.5 percent to 98.00 euros in early trade, while Germany’s blue-chip DAX index was up 0.2 percent. The news that Stimuvax failed its Phase III trial is also a fresh blow to Oncothyreon Inc, the vaccine’s developer.


But Merck said it had seen “notable treatment effects” in certain subgroups of patients and would analyse further data on the drug in the coming weeks. It said it would discuss the data with experts and regulatory authorities over the coming months.


Stimuvax is one of a number so-called therapeutic cancer vaccines being developed by drug companies to fight tumors by stimulating the body’s immune system.


The first such vaccine was approved two years ago but Provenge for prostate cancer, made by Dendreon, has met with limited success, due to management missteps and doctors’ reluctance to adopt the difficult-to-administer therapy.


A number of other cancer vaccines are in development that analysts believe may be more successful, including a product from GlaxoSmithKline against melanoma and lung cancer which is set to report clinical trial results next year.


Some investors had already been wary about prospects for Stimuvax after Merck said in March the trial would be continued and final data would be presented later than expected, raising doubts over its success.


“Given the history of the drug development with postponements, discontinuations and break-ups we are not surprised about today’s outcome,” DZ Bank analyst Peter Spengler said.


(Reporting by Maria Sheahan and Ben Hirschler; Editing by David Cowell)


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After Ghana vote, investors turn to economy






JOHANNESBURG (Reuters) – A closely fought but peaceful election in Ghana this month has burnished the international image of the west African oil, gold and cocoa producer as “the Switzerland of Africa.”


But to win economic bragging rights too, Ghana’s new government will have to convince investors that it can tame a swelling fiscal deficit, stabilize a volatile currency and rebuild foreign exchange reserves that have declined this year while those of other African economies have grown.






Elected President John Dramani Mahama‘s administration will have to confront these challenges while economic growth slows – albeit to a robust 7.8 percent projected for 2013, from a blistering 14.5 percent last year.


Then there is the pressure of high expectations from ordinary Ghanaians impatient to see the benefits of oil production, which started in 2010.


Investors say they would also like more opportunities to participate in Ghana’s capital markets, but the main constraints are a bond yield curve that ends at five years and a small and illiquid stock market with just 34 listed companies.


“Ghana is one of our favorite places,” said Sven Richter, head of frontier markets at Renaissance Asset Managers. “We would have more in Ghana if there was more liquidity. We have less than one percent of our fund there and we’d quite happily have 10 percent.”


Despite a legal challenge by the opposition to Mahama’s narrow victory earlier this month, the largely incident-free election in a region known for coups and civil wars has given foreign investors comfort.


“Someone described Ghana to us as the Switzerland of Africa. I think that’s an apt description,” said Ayo Salami, chief investment officer of asset manager Duet Group’s Africa Opportunities Fund. “There seems to be a continuing commitment on the part of the government to institutional reform, to embedding democratic culture. All these are things we like.”


But the government has to show it is serious about cutting Ghana’s twin deficits – on its budget and current account – which are putting pressure on the currency, Salami said, echoing the concerns of credit rating agencies.


Continuing an election year trend, heavy public spending forced the government to revise its 2012 budget deficit target to 6.7 percent of gross domestic product (GDP), from the original 4.8 percent. Some analysts think it could end up in double digits when figures are published next year.


Fitch, which affirmed Ghana’s B+ rating in September, said the gap reflects a combination of repayment of arrears, public sector wage increases and higher energy subsidies.


OIL HOPES


Finance Minister Kwabena Duffuor said last week the country would pursue a fourth year of fiscal consolidation in 2013, expecting oil, agriculture and an infrastructure program to underpin economic growth.


Salami at Duet Group warns, however, against relying too much on oil, even if output is set to increase to 120,000 barrels per day next year, from around 90,000 bpd now.


“I know the government is hoping or waiting for oil revenues to come as the cavalry over the hill to sort this out for them,” he said. “What usually happens is that when governments get a new source of revenue they find a new way to spend it.”


Ghana’s current account deficit is likely to hit 14 percent this year, from 11 percent last year, due to infrastructure spending and demand for imports from local businesses and a growing middle class.


The deficit contributed to a near 20 percent depreciation in the local cedi currency in the first half of the year before the central bank intervened.


But its efforts to shore up the cedi have hit Ghana’s foreign exchange reserves, now at $ 5.2 billion or 2.9 months of imports, just below the traditional 3-month benchmark. Ghana also bucks a sub-Saharan African trend as Nigeria, Kenya, Mozambique and others have built up their reserves this year.


DEBT CONCERNS


While the smooth elections may have allowed investors “to cut the country a bit more slack”, the worsening fiscal picture means they will not do so for long, said Giulia Pellegrini, JP Morgan strategist for sub-Saharan Africa.


She expects the cedi to lose another 5-8 percent in the new year. “Investors will increasingly be monitoring the fiscal and current account situation,” she said.


“People are taking in the full picture rather than simply saying ‘it’s stable, it’s looking good, let’s just go for it’. They’re becoming more discerning if anything.”


The country’s rapid accumulation of debt since debt relief is also a cause for concern, Pellegrini said, with external debt currently at $ 7.8 billion, nearly double its 2008 levels.


Finance Minister Duffuor said Ghana would issue a second Eurobond next year, which should help to lower borrowing costs. Ghana’s 2017 bond is trading at a yield of 4.9 percent, much lower than the 21 percent investors demanded for a 3-year domestic bond sold in October.


Given high liquidity globally and the success of previous Eurobonds from African sovereigns, the issue should do well. But investors could make Ghana pay if it does not work on its budget. “Investors would still show quite a bit of interest but would want to be compensated for that,” Pellegrini said.


(Reporting by Tosin Sulaiman; Editing by Pascal Fletcher/Ruth Pitchford)


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“Zero Dark Thirty” review: Like a really good “Law & Order” – with waterboarding






LOS ANGELES (TheWrap.com) – It’s always a challenge to tell a story where the audience knows the ending. The trick comes in offering a new perspective on familiar events or at least generating suspense in a way that makes us nervous that Apollo 13 might not land safely, even when history tells us otherwise.


“Argo” and “Lincoln” are two films that successfully tread these waters, and now comes “Zero Dark Thirty,” Kathryn Bigelow‘s eagerly awaited follow-up to “The Hurt Locker.”






She and screenwriter Mark Boal have consciously chosen to take a just-the-facts-ma’am approach to the manhunt and subsequent killing of Osama bin Laden, and while there’s no denying the skill with which they’ve gone about telling the tale, the results are simultaneously uninvolving and somewhat infuriating.


Uninvolving, to some extent, because the people in this movie are not so much characters as they are plot functionaries, chess pieces that move around strategically to capture their target. Jessica Chastain stars as Maya, a CIA agent who, with each passing year, grows more determined to nab the man behind the 9/11 attacks.


There’s nothing wrong with this style of storytelling — giving us some backstory about Maya’s taste in men or love of antique cars or whatever wouldn’t necessarily add anything to what Bigelow and Boal are trying to do here – but it’s a gamble that doesn’t quite pay off.


After spending its first half getting into the false leads and call-tracing and all the nitty-gritty of a manhunt, “Zero Dark Thirty” subjects its capable lead character to the requisite scene in which she snaps and barks at her bureaucrat boss (played by Kyle Chandler) that she’s so close, and not to take her off the case.


It’s a moment that feels like it might have come from any given episode of “Homeland” or any TNT show about a plucky female cop, and it capsizes a movie that, until that point, had been a fairly fascinating examination of the unglamorous sausage-making that goes into a worldwide search for a terrorist.


The somewhat infuriating facet comes early on, as we watch Maya observe seasoned interrogator Dan (Jason Clarke, giving a fascinating performance) torture terror suspects to find out what they know about September 11. The movie indirectly implies that waterboarding and electrodes to the genitals and all that other stuff that George W. Bush‘s consiglieri convinced him were kosher actually resulted in actionable intelligence, despite the reams of reportage that suggested otherwise.


I believe Bigelow and Boal’s after-the-fact denials that they intended to glorify torture in any way, but when you include material like this in a movie that takes such a coolly detached tone in telling its story, you can’t then be surprised later when some viewers interpret a filmmaker’s neutral tone as an implicit endorsement.


Still, even if the eventual raid on the bin Laden compound isn’t as exciting as the film’s first half (this is where some “Argo”-style suspense might have come in handy), there’s a lot to recommend about “Zero Dark Thirty,” which more often than not reflects Bigelow’s consummate abilities as an action filmmaker; her no-frills skills in mounting car chases, surveillance and the other tools of the CIA trade get a full workout.


The acting is also uniformly strong, although if you found the parade of famous faces popping up in “Lincoln” to be distracting, you ain’t seen nothing yet. Many recognizable performers turn up very briefly for their chance to be in the new Bigelow movie, to the occasional point of distraction. (I started counting lines from well-known actors; “Torchwood” star John Barrowman? Two.)


And even if “Zero Dark Thirty” packs something less of a punch than “The Hurt Locker,” it’s still a movie that’s going to part of the national discussion, both politically and artistically, and deservedly so. Whether you love it, hate it, or have mixed feelings, it’s not to be ignored.


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Syrian rebels take control of Damascus Palestinian camp






BEIRUT (Reuters) – Syrian rebels took full control of the Yarmouk Palestinian refugee camp on Monday after fighting raged for days in the district on the southern edge of President Bashar al-Assad‘s Damascus powerbase, rebel and Palestinian sources said.


The battle had pitted rebels, backed by some Palestinians, against Palestinian fighters of the pro-Assad Popular Front for the Liberation of Palestine-General Command (PFLP-GC). Many PFLP-GC fighters defected to the rebel side and their leader Ahmed Jibril left the camp two days ago, rebel sources said.






“All of the camp is under the control of the (rebel) Free Syrian Army,” said a Palestinian activist in Yarmouk. He said clashes had stopped and the remaining PFLP fighters retreated to join Assad‘s forces massed on the northern edge of the camp.


The battle in Yarmouk is one of a series of conflicts on the southern fringes of Assad’s capital, as rebels try to choke the power of the 47-year-old leader after a 21-month-old uprising in which 40,000 people have been killed.


Government forces have used jets and artillery to try to dislodge the fighters but the violence has crept into the heart of the city and activists say rebels overran three army stations in a new offensive in the central province of Hama on Monday.


On the border with Lebanon, hundreds of Palestinian families fled across the frontier following the weekend violence in Yarmouk, a Reuters witness said.


Syria hosts half a million Palestinian refugees, most living in Yarmouk, descendants of those admitted after the creation of Israel in 1948, and has always cast itself as a champion of the Palestinian struggle, sponsoring several guerrilla factions.


Both Assad’s government and the mainly Sunni Muslim Syrian rebels have enlisted and armed divided Palestinian factions as the uprising has developed into a civil war.


“NEITHER SIDE CAN WIN”


Syrian Vice President Farouq al-Sharaa said in a newspaper interview published on Monday that neither Assad’s forces nor rebels seeking to overthrow him can win the war.


Sharaa, a Sunni Muslim in a power structure dominated by Assad’s Alawite minority, has rarely been seen since the revolt erupted in March 2011 and is not part of the president’s inner circle directing the fight against Sunni rebels. But he is the most prominent figure to say in public that Assad will not win.


Sharaa said the situation in Syria was deteriorating and a “historic settlement” was needed to end the conflict, involving regional powers and the U.N. Security Council and the formation of a national unity government “with broad powers”.


“With every passing day the political and military solutions are becoming more distant. We should be in a position defending the existence of Syria. We are not in a battle for an individual or a regime,” Sharaa was quoted as telling Al-Akhbar newspaper.


“The opposition cannot decisively settle the battle and what the security forces and army units are doing will not achieve a decisive settlement,” he said, adding that insurgents fighting to topple Syria’s leadership could plunge it into “anarchy and an unending spiral of violence”.


Sources close to the Syrian government say Sharaa had pushed for dialogue with the opposition and objected to the military response to an uprising that began peacefully.


In a veiled criticism of the crackdown, he said there was a difference between the state’s duty to provide security to its citizens, and “pursuing a security solution to the crisis”.


He said even Assad could not be certain where events in Syria were leading, but that anyone who met him would hear that “this is a long struggle…and he does not hide his desire to settle matters militarily to reach a final solution.”


In Hama province, rebels and the army clashed in a new campaign launched on Sunday by rebels to block off the country’s north, activists said.


The Syrian Observatory for Human Rights, an opposition-linked violence monitor, said fighting raged through the provincial towns of Karnaz, Kafar Weeta, Halfayeh and Mahardeh.


It said there were no clashes reported in Hama city, which lies on the main north-south highway connecting the capital with Aleppo, Syria’s second city.


Qassem Saadeddine, a member of the newly established rebel military command, said on Sunday fighters had been ordered to surround and attack army positions across the province. He said Assad’s forces were given 48 hours to surrender or be killed.


In 1982 Hafez al-Assad, father of the current ruler, crushed an uprising in Hama city, killing up to 30,000 civilians.


Qatiba al-Naasan, a rebel from Hama, said the offensive would bring retaliatory air strikes from the government but that the situation is “already getting miserable”.


(Additional reporting by Oliver Holmes, Erika Solomon and Dominic Evans in Beirut, Afif Diab at Masnaa, Lebanon; editing by Philippa Fletcher)


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Hairstyles may keep some black women from exercise






NEW YORK (Reuters Health) – A number of obstacles may stand between a person and exercise, and hairstyles may be one of them for African-American women, according to a new study.


Researchers found about two of every five African-American women said they avoid exercise because of concerns about their hair, and researchers say that is concerning given the United States’ obesity epidemic.






“As an African-American woman, I have that problem, and my friends have that problem. So I wondered if my patients had that problem,” said Dr. Amy McMichael, the study’s senior researcher and a dermatologist at the Wake Forest University School of Medicine in Winston-Salem, North Carolina.


McMichael and her colleagues, who published their findings in the Archives of Dermatology on Monday, said hair care can be tedious and costly for African-American women.


Rochelle Mosley, who owns Salon 804 in the Harlem neighborhood of New York City, told Reuters Health some of her African-American clients come in once per week to get their hair straightened at a cost of about $ 40.


They may not want to wash their hair more than once a week to keep their hairstyle, and may avoid sweating because of that.


To find out if women were putting hair above their health, the researchers surveyed 103 African-American women who came to the dermatology clinic at Wake Forest University in October 2007.


They found that more than half of the women were exercising for less than 75 minutes per week, which is less than the U.S. Department of Health and Human Services‘ recommendation of 150 minutes of moderate-intensity exercise.


That’s also less than U.S. women on average, according to a 2007 study from the U.S. Centers for Disease Control and Prevention that found about half of all U.S. women were exercising close to 150 minutes per week.


More than a quarter of the women in the new study said they didn’t exercise at all.


About a third of the women said they exercise less than they’d like because of their hair, and half said they have considered changing their hair for exercise.


McMichael and her colleagues found that women who avoided exercise because of their hair were almost three times less likely to meet the recommended physical activity guidelines. That finding, however, could have been due to chance.


Also, scalp issues, such as itching and dandruff, played a role in the women’s decision-making process.


SALON OWNER NOT SURPRISED


McMichael also admits that they only surveyed African-American women, and they can’t say whether this is a problem shared by other ethnicities.


“It is a really important conversation that African-American women want to have, and they’re looking for solutions,” said McMichael.


Salon 804′s Mosley told Reuters Health that she’s not surprised by the findings based on her 22 years in business.


Previously, studies have connected people who get their hair done and their overall health. Some barbershops and salons even act as health clinics (see Reuters article of June 29, 2011 here: http://reut.rs/WjFXgB).


Mosley added that some women schedule their visits around their exercise schedule, but she also tries to find a hairstyle that will work with physical activity.


“If you don’t have a healthy body then you aren’t going to have any hair to fix,” she said.


SOURCE: http://bit.ly/WjBo5P Archives of Dermatology, online December 17, 2012.


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Sweden cuts main interest rate to 1 percent






STOCKHOLM (AP) — Sweden‘s central bank has cut its key interest rate by a quarter of a percentage point to 1 percent as inflationary pressures remain benign and problems in Europe weigh on the Scandinavian country’s economy.


Tuesday’s decision was widely expected.






The Riksbank also says that its main interest rate will likely “remain at this low level for the coming year” due to the economic slowdown, rising unemployment and subdued inflation.


By the end of 2013, it expects inflation to start edging up as the global economic recovery gathers steam, partly on the back of recent measures taken by the 17 EU countries that use the euro to get a grip on their 3-year debt crisis.


The Riksbank says the weaker European economy has so far had “a clear effect” on Sweden.


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“The Playroom” lands distributor






LOS ANGELES (TheWrap.com) – Freestyle Releasing and Freestyle Digital Media have acquired the theatrical, DVD and VOD rights to “The Playroom,” a drama directed by Julia Dyer (“Late Bloomers”), which stars John Hawkes (“Winter’s Bone,” “The Sessions”) and Molly Parker (“Dexter,” “The Firm”).


The film is slated for a day-and-date theatrical release and on DVD/VOD on February 8, 2013.






“The Playroom” premiered in the gala/spotlight section of this year’s Tribeca Film Festival. It was produced by Stephen Dyer (“Hysteria”) and Angie Meyer (“Wuss”).


Set in the suburbs during the1970s, the family drama tells the story of Maggie (Olivia Harris), a vulnerable teenager who acts as a big sister to her three younger siblings. Upstairs in the attic, she tells them stories to mask what is happening downstairs with their hard-drinking parents.


Julia Dyer has created a beautiful time machine back to the ’70s,” said Susan Jackson, president of Freestyle. “The film is a bird’s eye view of a tumultuous period told from the perspective of children.”


Freestyle Digital Media‘s slate of releases includes “Samsara,” from Ron Fricke and Mark Magidson, as well as the recently released “You May Not Kiss the Bride,” starring Katharine McPhee and Rob Schneider.


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Iran media: Son of ex-president released on bail






TEHRAN, Iran (AP) — Iranian media say the son of influential former President Akbar Hashemi Rafsanjani has been released on bail.


Several papers, including the pro-reform Etemad daily, say Mahdi Hashemi was released late Sunday and immediately went to his father’s home.






Authorities arrested the younger Hashemi in late September, a day after he returned to Iran from Britain.


He is held on charges of fomenting unrest in the aftermath of Iran’s disputed 2009 presidential election that brought President Mahmoud Ahmadinejad a second term in office. Hashemi also faced corruption charges.


His arrest came days after his sister, Faezeh, was taken into custody to serve a six-month sentence on charges of making propaganda against Iran’s ruling system.


Since Rafsanjani backed Ahmadinejad’s reformist challenger in 2009, his family has come under pressure from hardliners.


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Kat Von D Accepts DJ Deadmau5′s Marriage Proposal — Via Twitter






Saturday was just another crazy day in the love life of Kat Von D – you know, marriage proposals via Tweet, etc.


After a two-month hot and heavy romance with Canadian DJ Deadmau5 (followed by a November breakup), the pair is not only back together, they’re engaged — and it all went down on Twitter.






PLAY IT NOW: Meet The Six Little McGhees


“I can’t wait for Christmas so…. Katherine Von Drachenberg, will you marry me?” Deadmau5 (Joel Zimmerman) Tweeted on Saturday, along with a photo of the engagement ring he plans to get the tattoo artist.


Click HERE to see the ring – complete with a diamond flanked by (what else?!) two skulls!


VIEW THE PHOTOS: Stars Who Got Engaged In 2012


Kat replied with a series of exclamation points, to which Deadmau5 romantically responded with, “Holy f***ing s**t. im engaged and stuff!”


The freshly-minted engaged couple then thanked their followers for their support.


“Mi corazon!!! Thank you all for the lovely congratulations!” Kat wrote. “Please excuse me while I go squeeze the hell out of my fiance!”


VIEW THE PHOTOS: Guess The Celebrity Ink!


“Thanks for the well wishes and support from the horde and everyone else!” Deadmau5 Tweeted. “brb while i spend the rest of my evening with my future wife icon smile Kat Von D Accepts DJ Deadmau5s Marriage Proposal    Via Twitter


VOTE: Will Kat & Deadmau5 make it down the aisle?


VIEW THE PHOTOS: Hollywood’s Smokin’ Hot Couples


Prior to her whirlwind romance with Deadmau5, Kat was recently engaged to Sandra Bullock’s ex-husband, Jesse James, but the now-ex-couple broke it off in June, 2011.


As previously reported on AccessHollywood.com, Kat and her new fiance, dubbed “Kat and Mau5″ (mouse), were first spotted together in September, and the DJ called Kat “The love of my life” just one month later.


One month after his declaration of love, the pair broke up.


– Erin O’Sullivan


Copyright 2012 by NBC Universal, Inc. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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Keep thimerosal in vaccines: pediatricians






NEW YORK (Reuters Health) – A mercury-containing preservative should not be banned as an ingredient in vaccines, U.S. pediatricians said Monday, in a move that may be controversial.


In its statement, the American Academy of Pediatrics (AAP) endorsed calls from a World Health Organization (WHO) committee that the preservative, thimerosal, not be considered a hazardous source of mercury that could be banned by the United Nations.






Back in 1999, a concern that kids receiving multiple shots containing thimerosal might get too much mercury – and develop autism or other neurodevelopmental problems as a result – led the AAP to call for its removal, despite the lack of hard evidence at the time.


“It was absolutely a matter of precaution because of the absence of more information,” said Dr. Louis Cooper, from Columbia University in New York, who was on the organization’s board of directors at the time.


“Subsequently an awful lot of effort has been put into trying to sort out whether thimerosal causes any harm to kids, and the bottom line is basically, it doesn’t look as if it does,” Cooper, who wrote a commentary published with the AAP’s statement, told Reuters Health.


In a 2004 safety review, for example, the independent U.S. Institute of Medicine concluded there was no evidence thimerosal-containing vaccines could cause autism. A study from the Centers for Disease Control and Prevention came to the same conclusion in 2010.


With the exception of some types of flu shots, the compound is not used in vaccines in the United States, which are distributed in single-dose vials.


And nobody is arguing that should change, according to Dr. Walter Orenstein, a member of the AAP Committee on Infectious Diseases and a researcher at the Emory Vaccine Center in Atlanta.


But in countries with fewer resources – where many children still die of vaccine-preventable diseases – it’s cheaper and easier to use multi-dose vials of vaccines against diphtheria and tetanus, for example.


Thimerosal prevents the rest of a multi-dose vial from getting contaminated with bacteria or fungi each time a dose is used.


Researchers estimated it could cost anywhere from two to five times as much to manufacture vaccines for developing countries without thimerosal, and both transporting vaccines and keeping them refrigerated would be much harder as well.


“If we had to take the thimerosal out of those multi-dose vials, we’re having a hard time completing the task of getting every kid immunized now, that would add a tremendous burden,” Cooper said – and more children would probably die as a result.


“Children who can now be protected from these life-threatening diseases could become vulnerable,” Orenstein told Reuters Health.


The new statement is published in the AAP’s journal Pediatrics.


Thimerosal contains a type of mercury called ethyl mercury. Toxic effects have been tied to its cousin, methyl mercury, which stays in the body for much longer.


Earlier this year, the WHO said replacing thimerosal with an alternative preservative could affect vaccine safety and might cause some vaccines to become unavailable.


Mercury, however, is still on the list of global health hazards to be banned in a draft treaty from the United Nations Environment Program – which would mean a ban on thimerosal.


Reducing mercury exposure “is a wonderful thing,” Orenstein said.


However, “We need this exception because thimerosal is so vital for protecting children.”


He said keeping thimerosal in vaccines is essential mostly for humanitarian reasons – although preventing childhood diseases in the developing world could also help the U.S. because other countries can serve as reservoirs for illness.


“For American parents, this is more looking at the world and our role and responsibility in protecting the children of the world than it is a direct impact,” Orenstein said.


SOURCE: http://bit.ly/cxXOG Pediatrics, online December 17, 2012.


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