Pharmacy Blames Cleaners in Meningitis Outbreak

Jan 4, 2013 11:41am

Credit: Minnesota Department of Health/AP Photo

The pharmacy at the heart of the fungal meningitis outbreak says a cleaning company it hired should share the blame for the tainted steroid injections that caused more than 600 illnesses in 19 states, killing 39 people.

Click here to read about the road to recovery for fungal meningitis victims.

The New England Compounding Pharmacy, which made the fungus-tainted drugs, sent a letter to UniFirst Corp., which provided once-a month cleaning services to the Framingham, Mass., lab, “demanding” it indemnify NECC for the meningitis outbreak, according to a UniFirst filing with the Securities and Exchange Commission.

“Based on its preliminary review of this matter, the company believes that NECC’s claims are without merit,” UniFirst wrote in its quarterly filing.

The New England Compounding Center recalled 17,000 vials of tainted steroid injections on Sept. 26 before recalling all drugs and shutting down on Oct. 6.

The Food and Drug Administration investigated NECC’s lab and found that a quarter of the steroid injections in one bin contained “greenish black foreign matter,” according to the report.  The FDA also identified several cleanrooms that had bacterial or mold overgrowths.

UniFirst’s UniClean business cleaned portions of the NECC cleanrooms to NECC’s specifications and using NECC’s cleansing solutions, UniFirst spokesman Adam Soreoff said in a statement. It provided two technicians once a month for about an hour and a half.

“UniClean was not in any way responsible for NECC’s day-to-day operations, its overall facility cleanliness, or the integrity of the products they produced,” Soreoff said. “Therefore, based on what we know, we believe any NECC claims against UniFirst or UniClean are unfounded and without merit. ”

Click here for our fungal meningitis outbreak timeline, “Anatomy of an Outbreak.”

NECC was not immediately available for comment.

The House of Representatives subpoenaed Barry Cadden, who owns NECC,  to a hearing in Washington, D.C. on Nov. 14. He declined to testify when members of Congress pressed him on his role in ensuring that the drugs his company produced were safe and sterile.

“On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges including the Fifth Amendment of the Constitution of the United States,” he said at the hearing.

Members of Congress also questioned whether the FDA could have prevented the outbreak.

Compounding pharmacies, which are intended to tailor drugs to individuals with a single prescription from a single doctor, are typically overseen by state pharmacy boards rather than the FDA because they are so small. However, in 2006, the FDA issued a warning letter to NECC, accusing it of mass-producing a topical anesthetic cream, and jeopardizing another drug’s sterility by repackaging it.

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Abbas sees Palestinian unity as Fatah rallies in Gaza

GAZA (Reuters) - President Mahmoud Abbas predicted the end of a five-year split between the two big Palestinian factions as his Fatah movement staged its first mass rally in Gaza with the blessing of Hamas Islamists who rule the enclave.

"Soon we will regain our unity," Abbas, whose authority has been limited to the Israeli-occupied West Bank since the 2007 civil war between the two factions, said in a televised address to hundreds of thousands of followers marching in Gaza on Friday, with yellow Fatah flags instead of the green of Hamas.

The hardline Hamas movement, which does not recognize Israel's right to exist, expelled secular Fatah from Gaza during the war. It gave permission for the rally after the deadlock in peace talks between Abbas's administration and Israel narrowed the two factions' ideological differences.

The Palestinian rivals have drawn closer since Israel's assault on Gaza assault in November, in which Hamas, though battered, claimed victory.

Egypt has long tried to broker Hamas-Fatah reconciliation, but past efforts have foundered over questions of power-sharing, control of weaponry, and to what extent Israel and other powers would accept a Palestinian administration including Hamas.

An Egyptian official told Reuters Cairo was preparing to invite the factions for new negotiations within two weeks.

Israel fears grassroots support for Hamas could eventually topple Abbas's Palestinian Authority (PA) in the West Bank.

"Hamas could seize control of the PA any day," Israeli Prime Minister Benjamin Netanyahu said on Thursday.

The demonstration marked 48 years since Fatah's founding as the spearhead of the Palestinians' fight against Israel. Its longtime leader Yasser Arafat signed an interim 1993 peace accord that won Palestinians a measure of self rule.

Hamas, which rejected the 1993 deal, fought and won a Palestinian parliamentary election in 2006. It formed an uneasy coalition with Fatah until their violent split a year later.

Though shunned by the West, Hamas feels bolstered by electoral gains for Islamist movements in neighboring Egypt and elsewhere in the region - a confidence reflected in the fact Friday's Fatah demonstration was allowed to take place.

"The success of the rally is a success for Fatah, and for Hamas too," said Hamas spokesman Sami Abu Zuhri. "The positive atmosphere is a step on the way to regain national unity."

Fatah, meanwhile, has been riven by dissent about the credibility of Abbas's statesmanship, especially given Israel's continued settlement-building on West Bank land. The Israelis quit Gaza unilaterally in 2005 after 38 years of occupation.

"The message today is that Fatah cannot be wiped out," said Amal Hamad, a member of the group's ruling body, referring to the demonstration attended by several Abbas advisers. "Fatah lives, no one can exclude it and it seeks to end the division."

In his speech, Abbas promised to return to Gaza soon and said Palestinian unification would be "a step on the way to ending the (Israeli) occupation".

(Editing by Dan Williams, Alistair Lyon and Jason Webb)

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Westinghouse to show Roku Ready TV at CES

Westinghouse's UX60 will be certified Roku Ready.

(Credit:
Westinghouse)

Today Westinghouse announced a line of TVs designed to work with the Roku Streaming Stick, a USB-key-sized dongle that provides the functionality of a full-fledged Roku box--our Editors' Choice for streaming video--without having to connect additional wires.

The TVs have MHL (Mobile High Definition Link)-enabled HDMI inputs, into which the stick can be plugged. Numerous other MHL-equipped TVs will also be announced at
CES next week, theoretically allowing them to also work with the Stick, but many will likely have their own Smart TV suites built in, and few will be guaranteed such functionality by offering Roku Ready certification.

A Stick plugged into an Insignia TV's HDMI input.

(Credit:
Sarah Tew/CNET)

CNET spoke to Westinghouse VP of Marketing Rey Roque, who said the company will show a 60-inch, edge-lit
LED TV at CES that's bundled with the stick. The TV's remote will control both the set and the full Roku experience. Westinghouse will also sell smaller sizes (46, 50 and 55) that might also be bundled, as well as Roku Ready TVs that don't include the $99 stick.

Currently we know about a couple of other Streaming Stick Ready TVs, from Hitachi and Insignia. In our review of the latter the Stick worked well, replicating the full Roku experience, so we expect the same from these Westinghouse models.

The Stick is currently a niche product and most buyers would be better served with a standard Roku box, especially when paired with a good universal remote. But if more TVs like the Westinghouse come out, and especially if that $99 price drops, the future of streaming video could be on a stick.

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FTC: Google does not violate antitrust laws

Google hasn't violated any antitrust laws, the Federal Trade Commission announced Thursday, but it has agreed to make some changes in how it treats its rivals as part of a settlement to end the 19-month investigation into its business practices.

The FTC's investigation focused on allegations that Google has been abusing its dominance in Internet search. Google's rivals say the company has been highlighting its own services on its influential results page while burying the links to competing sites.

Google Inc. has fiercely defended its right to recommend the websites that it believes are the most relevant.

The FTC said it voted unanimously to close the investigation on whether Google's algorithm unfairly favored itself because there was no evidence that Google violated antitrust laws.

"Although some evidence suggested that Google was trying to eliminate competition, Google's primary reason for changing the look and feel of its search results to highlight its own products was to improve the user experience," FTC chairman Jon Leibowitz said to reporters Thursday.

Google was also investigated for abusing patent protection against competitors like Apple. As part of the settlement, Google is agreeing to license patents deemed to be "essential" for rival mobile devices such as Apple Inc.'s iPhone and iPad, regulators said.

Regulators say Google is also promising that upon request, it will exclude snippets copied from other websites in its summaries of key information, even though the company had insisted the practice is legal under the fair-use provisions of U.S. copyright law.

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Sandy Hook Parents Cope With Students' Return

Sandy Hook parents put their children on school buses this morning and waved goodbye as the yellow bus rolled away, but this first day back since the pre-Christmas massacre is anything but normal for the families of Sandy Hook Elementary School.

Erin Milgram, the mother of a first grader and a fourth grader at Sandy Hook, told "Good Morning America" that she was going to drive behind the bus and stay with her 7-year-old Lauren for the entire school day.

"I haven't gotten that far yet, about not being with them," Milgram said. "I just need to stay with them for a while."

Today is "Opening Day" for Sandy Hook Elementary School, which is re-opening about six miles away in the former Chalk Hill school in Monroe, Conn.

Lauren was in teacher Kaitlin Roig's first grade class on Dec. 14 when gunman Adam Lanza forced his way into the school and killed 20 students and six staffers.

Roig has been hailed a hero for barricading her students in a classroom bathroom and refusing to open the door until authorities could find a key to open the door.

The 20 students killed were first-graders and the Milgrams have struggled to explain to Lauren why so many of her friends will never return to school.

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"She knows her friends and she'll also see on the bus... there will be some missing on the bus," Milgram said. "We look at yearbook pictures. We try to focus on the happy times because we really don't know what we're doing."

"How could someone be so angry?" Lauren's father Eric Milgram wondered before a long pause. "We don't know."

The school has a lecture room available for parents to stay as long as they wish and they are also allowed to accompany their children to the classroom to help them adjust. Counselors will be available throughout the day for parents, staff and students, according to the school's website.

The first few days will be a delicate balancing act between assessing the children's needs and trying to get them back to a normal routine.

"We don't want to avoid memories of a trauma," Dr. Jamie Howard told "Good Morning America." "And so by getting back to school and by engaging in your routines, we're helping kids to do that, we're helping them to have a natural, healthy recovery to a trauma."

Security is paramount in everyone's mind. There is a police presence on campus and drivers of every vehicle that comes onto campus are being interviewed.

"Our goal is to make it a safe and secure learning environment for these kids to return to, and the teachers also," Monroe police Lt. Keith White said at a news conference on Wednesday.

A "state-of-the-art" security system is in place, but authorities will not go into detail about the system saying only that the school will probably be "the safest school in America."

White said at a news conference today that the security presence would be evaluated on a day-by-day and week-by-week basis moving forward.

"We are trying to keep a balance," he said. "We don't want them [the students] to think that this is a police state. This is a school and a school first."

Every adult in the school who is not immediately recognizable will be required to wear a badge as identification, parent and school volunteer Karen Dryer told ABCNews.com.

"They want to know exactly who you are at sight, whether or not you should be there," Dryer said.

Despite the precautions and preparations, parents will still be coping with the anxiety of parting with their children.

"Rationally, something like this is a very improbable event, but that still doesn't change the emotional side of the way you feel," Eric Milgram said.

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Syria rebels in push to capture air base

AZAZ, Syria (Reuters) - Rebels battled on Thursday to seize an air base in northern Syria, part of a campaign to fight back against the air power that has given President Bashar al-Assad's forces free rein to bomb rebel-held towns.

More than 60,000 people have been killed in the 21-month-old uprising and civil war, the United Nations said this week, sharply raising the death toll estimate in a conflict that shows no sign of ending.

After dramatic advances over the second half of 2012, the rebels now hold wide swathes of territory in the north and east, but are limited in exerting control because they cannot protect towns and villages from Assad's helicopters and jets.

Hundreds of fighters from rebel groups were attempting to storm the Taftanaz air base, near the northern highway that links Syria's two main cities, Aleppo and the capital Damascus.

Rebels have been besieging air bases across the north in recent weeks, in the hope this will reduce the government's power to carry out air strikes and resupply loyalist-held areas.

A rebel fighter speaking from near the Taftanaz base overnight said the base's main sections were still in loyalist hands but insurgents had managed to infiltrate and destroy a helicopter and a fighter jet on the ground.

The northern rebel Idlib Coordination Committee said the rebels had detonated a car bomb inside the base.

The government's SANA news agency said the base had not fallen and that the military had "strongly confronted an attempt by the terrorists to attack the airport from several axes, inflicting heavy losses among them and destroying their weapons and munitions".

Rami Abdulrahman, head of the opposition-aligned Syrian Observatory for Human Rights which monitors the conflict from Britain, said as many as 800 fighters were involved in the assault, including Islamists from Jabhat al-Nusra, a powerful group that Washington considers terrorists.

Taftanaz is mainly a helicopter base, used for missions to resupply army positions in the north, many of which are cut off by road because of rebel gains, as well as for dropping crude "barrel bombs" of explosives on rebel-controlled areas.

"WHAT IS THE FAULT OF THE CHILDREN?"

Near Minakh, another northern air base that rebels have surrounded, government forces have retaliated by regularly shelling and bombing nearby towns.

In the town of Azaz, where the bombardment has become a near nightly occurrence, shells hit a family house overnight. Zeinab Hammadi said her two wounded daughters, aged 10 and 12, had been rushed across the border to Turkey, one with her brain exposed.

"We were sleeping and it just landed on us in the blink of an eye," she said, weeping as she surveyed the damage.

Family members tried to salvage possessions from the wreckage, men lifting out furniture and children carrying out their belongings in tubs.

"He (Assad) wants revenge against the people," said Abu Hassan, 33, working at a garage near the destroyed house. "What is the fault of the children? Are they the ones fighting?"

Opposition activists said warplanes struck a residential building in another rebel-held northern town, Hayyan, killing at least eight civilians.

Video footage showed men carrying dismembered bodies of children and dozens of people searching for victims in the rubble of the destroyed building, shouting "God is greatest". The provenance of the video could not be independently confirmed.

In addition to their tenuous grip on the north, the rebels also hold a crescent of suburbs on the edge of Damascus, which have come under bombardment by government forces that control the center of the capital.

On Wednesday, according to opposition activists, dozens of people were incinerated in an inferno caused by an air strike on a petrol station in a Damascus suburb where residents were lining up for precious fuel.

The civil war in Syria has become the longest and bloodiest of the conflicts that rose out of uprisings across the Arab world in the past two years.

Assad's family has ruled for 42 years since his father seized power in a coup. The war pits rebels, mainly from the Sunni Muslim majority, against a government supported by members of Assad's Shi'ite-derived Alawite minority sect and some members of other minorities who fear revenge if he falls.

The West, most Sunni-ruled Arab states and Turkey have called for Assad to leave power. He is supported by Russia and Shi'ite Iran.

(Additional reporting by Khaled Yacoub Oweis in Amman and Dominic Evans in Beirut; Writing by Peter Graff; Editing by Ruth Pitchford)

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Relief for Google as US ends monopoly probe

WASHINGTON: US regulators Thursday closed a lengthy antitrust probe into Google, saying there was not enough evidence to show the Internet giant manipulated its search results to harm its competitors.

The Federal Trade Commission said it lacked a legal basis to bring a monopoly abuse case against Google for "search bias," as alleged by some rivals, but won commitments from the tech titan to end its "most troubling" practices on search and advertising.

FTC chairman Jon Leibowitz said the action concludes a year-and-a-half probe of the Internet giant, accused by rivals of abusing its market dominance.

Many of Google's critics "wanted the Commission to go further in this investigation and regulate the intricacies of Google's search engine algorithm," Leibowitz said.

The FTC "exhaustively investigated allegations that Google unfairly manipulated its search engine results to harm its competitors," but found the evidence did not support an enforcement action, he said.

"The facts weren't there under the law we apply," he Leibowitz added.

Even though some rivals dislike Google search, "it doesn't violate the American antitrust laws," he said.

Still, Google made "enforceable commitments" to change some practices criticised by rivals in a voluntary settlement.

Leibowitz said Google had "committed to stop the most troubling of its business practices related to Internet search and search advertising."

Google agreed to stop misappropriating or "scraping" the content of rivals that makes it appear as if it were from Google and to drop contractual restrictions that limited the ability of small businesses to advertise on competing search engines, he said.

In a separate patent case, Google agreed to an FTC order "to stop seeking to exclude competitors using essential patents," mainly from Motorola, which Google purchased, the FTC chief said.

The action in Washington leaves unclear the outcome of a similar probe by the European Commission into Google's alleged monopoly abuse.

The European Union said last month it was still seeking commitments from the US firm that it abused its dominant market position in Internet search.

Google's chief legal officer David Drummond said of the FTC decision: "The conclusion is clear: Google's services are good for users and good for competition."

Drummond added, "We've always accepted that with success comes regulatory scrutiny. But we're pleased that the FTC and the other authorities that have looked at Google's business practices... have concluded that we should be free to combine direct answers with Web results. So we head into 2013 excited about our ability to innovate for the benefit of users everywhere."

Leibowitz said Google's commitments are "binding" and "enforceable" because the company made a written pledge to the federal regulatory agency. Any violation of those promises could result in fines, he said.

"This is a major victory for Google," said Greg Sterling, an analyst with Sterling Market Intelligence who blogs at Search Engine Land.

"The search bias argument was always one of the hardest and most unconvincing parts of any potential case against Google -- though it's the issue competitors probably care most about."

Sterling said EU regulators "arguably have a stronger negotiating position than the FTC. The Europeans also seem more intent on exacting bigger concessions from Google than the FTC. Yet a full-blown antitrust action against the company in Europe is unlikely."

Google has close to 70 per cent of the search market in the United States, and more in some other markets.

According to the research firm eMarketer, Google had around 75 per cent of US Internet search advertising revenues and 93 per cent in the mobile search ad market.

- AFP/jc

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What Google's settlement with the FTC means for users

FTC Chairman Jon Leibowitz announces the Google agreement.

(Credit:
Screenshot by CNET)

The Federal Trade Commission announced today that it has completed a nearly two-year investigation into Google's business practices. Here are some of the key takeaways:

On the issue most important to Google, Google won. The most potentially damaging line of inquiry undertaken by the FTC concerned accusations that Google's search results were unfairly biased in favor of its own products. Some critics wanted to see mandated changes to Google algorithms. But after considering a number of approaches, FTC commissioners decided unanimously that Google was not violating any antitrust laws when it comes to search results. For Google, this is a major victory.

Search results are going to look more or less the same. A handful of companies may choose to stop showing their results inside Google products like Google+ Local, Google Shopping, and Hotels. But otherwise Google can continue operating as normal.

Competitors are upset with the decision.
FairSearch, which represented many of the Google competitors pressing for stronger action, was among those who predicted that the FTC's decision would allow Google to further consolidate its power. "The FTC's inaction on the core question of search bias will only embolden Google to act more aggressively to misuse its monopoly power to harm other innovators," the group said in a statement. Yelp, who has been among the company's most vocal critics, called it "a missed opportunity to protect innovation in the Internet economy, and the consumers and businesses that rely upon it."

Google will have to license some of the patents it acquired from Motorola more liberally. The FTC found that Google's use of some of the patents it acquired from Motorola to be anticompetitive. Google can no longer file injunctions against competitors that make use of those patents, which are needed for complying with technical standards. In the settlement's only binding agreement, Google agreed to allow competitors access to the patents, "on fair, reasonable and non-discriminatory terms."

The victories won by Google's critics here are minor and technical. In response to the investigation, Google said it would allow creators of vertical search products like Yelp and travel-booking services to opt out of having their results "scraped" and displayed on certain Google results pages. To opt out, companies must fill out a Web-based notice form to be made available within 90 days. In a separate agreement, advertisers won a concession from Google on its AdWords platform; Google will modify the product to let advertisers more easily manage ad campaigns that run both on AdWords and competing platforms.

All eyes now turn to the European Commission, which has mounted a separate antitrust investigation into Google's business practices. Google Executive Chairman Eric Schmidt and the European Union antitrust chief Joaquin Almunia met last month in Brussels, Belgium. At the time, Almunia said he expected an offer from Google this month to settle its additional antitrust probe.

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Sandy Hook survivors welcomed at new school

A man waves to a child on a bus on the first day of classes after the holiday break, in Newtown, Conn.,Wednesday, Jan. 2, 2013. / AP Photo/Jessica Hill

Updated 1:21 p.m. ET

MONROE, Conn. The children who escaped last month's shooting at Sandy Hook Elementary School in Newtown were welcomed Wednesday to a school in a neighboring town that was overhauled specially for them.

Play Video

Orientation day for Sandy Hook students

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Heroism of Sandy Hook teachers

The open house at the former Chalk Hill School in Monroe marks the students' first time in a formal classroom setting since the massacre on Dec. 14, when a gunman killed 20 of their fellow classmates and six educators. Classes are starting for the Sandy Hook students on Thursday.

The road leading to the school in a rural, largely residential neighborhood was lined with signs greeting the students, saying "Welcome Sandy Hook Elementary School" and "Welcome. You are in our prayers." Several police cars were parked outside the school.

Teams of workers, many of them volunteers, prepared the former Chalk Hill middle school with fresh paint and new furniture and even raised bathroom floors so the smaller elementary school students can reach the toilets. The students' desks, backpacks and other belongings that were left behind following the shooting were taken to the new school to make them feel at home. Superintendent Janet Robinson said the rooms may not look exactly the same, but the school has been renamed Sandy Hook Elemntary.

Monroe police officers said at a press conference Wednesday it was "the safest school" in the country.

Counselors say it's important for children to get back to a normal routine and for teachers and parents to offer sensitive reassurances.

When classes start on Thursday, Robinson said teachers will try to make it as normal a school day as possible for the children.

"We want to get back to teaching and learning," she said. "We will obviously take time out from the academics for any conversations that need to take place, and there will be a lot of support there. All in all, we want the kids to reconnect with their friends and classroom teachers, and I think that's going to be the healthiest thing."

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Lawmakers Furious at Boehner Over Sandy 'Betrayal'

Republican lawmakers from New York and New Jersey whose storm-ravaged residents are desperate for federal aid are fuming at their party's leaders for refusing to hold a vote on a $60 billion disaster relief package despite promises that help was on the way.

"This was a betrayal," Rep. Michael Grimm, R-N.Y., told ABC News.com. "It's just reprehensible. It's an indefensible error in judgment not have given relief to these people that are so devastated."

New Jersey Gov. Chris Christie, a Republican, called it a "dereliction of duty" in a joint statement with New York Gov. Andrew Cuomo, a Democrat.

"This failure to come to the aid of Americans following a severe and devastating natural disaster is unprecedented," the governors said.

Lawmakers were told by Speaker John Boehner, R-Ohio, that the relief bill would get a vote on Tuesday night following an eleventh hour vote on the fiscal cliff bill. But in an unexpected switch, Boehner refused to put the relief bill to a vote, leading to lawmakers from parties yelling on the floor of the House.

Congress historically has responded to natural disasters by promptly funding relief efforts. The Senate already passed its version of the bill that would replenish an emergency fund set to run out of cash next week and which will help repair subways and tunnels in New York City and rebuild parts of the New Jersey shore devastated by superstorm Sandy.

Time is particularly pressing, given that a new Congress will be sworn in Thursday. The Senate will therefore have to vote on the bill again before it comes to the House, which could be as late as February or March.

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Rep. Peter King, R- N.Y., took the floor of the House and to the airwaves and aimed his outrage squarely at Boehner, accusing him plunging "a cruel knife in the back" of storm-ravaged residents "who don't have shelter, don't have food," he said during a House session this morning.

"This is not the United States. This should not be the Republican Party. This shouldn't not be the Republican leadership," King said on the floor of the House.

He made no attempt to hide his anger, suggesting that residents in New York and New Jersey should stop sending money to Republicans and even questioning aloud whether he could remain a member of the party.

"Anyone who donates one cent to the Republican Congressional Campaign Committee should have their head examined," King, a staunch conservative and Republican congressman for 10 years, told CNN.

"They have written off New York and New Jersey. They've written me off…. Party loyalty, I'm over that. When your people are literally freezing in the winter… Then why should I help the Republican Party?" he added.

He said that Boehner refused to talk to Republican members from New York and New Jersey when they tried to ask him about the vote Tuesday night.

"He just decided to sneak off in the dark of night," King said.

Democrats were also outraged.

"It is truly heartless that the House will not even allow the Sandy bill to come to the floor for a vote, and Speaker Boehner should reconsider his ill advised decision," Sen. Chuck Schumer, D- N.Y., said in a statement.

October's storm was the worst natural disaster ever to hit the region, causing billions in damage and leaving 120 people dead.

More than 130,000 people are expected to make claims to the federal government, but without a funding increase only about 12,000 people can be covered with existing funds.

"It doesn't make sense they wouldn't vote on this. There are truly people in need," said Steve Greenberg, whose home was flooded and damaged by fire in the hard-hit Breezy Point section of Queens. "Not of these people are fit to serve," he said.

Grimm said Boehner's decision fuels a perception that the Republican Party does not care about people.

"It buys into the ideology that Republicans don't care and are callous," he said. Grimm said there were enough votes to get the bill passed and that it makes fiscal sense, because the money would go to help spur small businesses.

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