Meningitis-linked U.S. firm not a drug maker in 2003 -report

WASHINGTON (Reuters) – Government health regulators in 2003 told the pharmacy now at the center of a deadly meningitis outbreak that its drug compounding activities did not constitute a manufacturing operation that would merit strict federal safety standards, a congressional report said on Monday.

The report by the Republican staff of a U.S. House of Representatives committee, said the Food and Drug Administration and Massachusetts state officials decided to leave oversight of the New England Compounding Center to a state pharmacy board, despite evidence of health problems linked to two drugs in 2002.

One of the drugs was methylprednisolone acetate, the same steroid treatment health officials have identified as the source of a current U.S. fungal meningitis outbreak that the U.S. Centers for Disease Control and Prevention says has grown to 438 cases, including 32 deaths, in 19 states.

Where to draw the line between drug manufacturing and drug compounding is a central question for U.S. lawmakers, who will hold separate House and Senate hearings this week as part of two investigations to determine whether the FDA should be given stronger authority to regulate compounding operations.

The House Energy and Commerce Committee, which produced the Republican report, is scheduled to hold its hearing on Wednesday with testimony expected from FDA Commissioner Margaret Hamburg, interim Massachusetts health commissioner Lauren Smith and NECC co-owner Barry Cadden, who has been subpoenaed to appear.

A separate hearing before the Senate Health, Education, Labor and Pensions Committee is scheduled for Thursday with a similar roster of witnesses expected.

A handful of Democrats have called for new legislation to strengthen federal oversight of the compounding industry, in which pharmacists traditionally alter or recombine drugs to meet the special needs of specific patients.

Drug compounding has evolved in recent decades to include large-scale production that some experts view as drug manufacturing that should be subject to FDA regulation.

But the compounding industry is currently overseen mainly by state authorities that are often ill-equipped for the job.

Up to now, compounding pharmacies have waged long legal and lobbying battles to stave off federal regulation. And some in Congress worry that failure to act before the end of the current lame duck session could postpone legislation in 2013 and risk losing momentum driven by the growing number of cases.

The advocacy group Public Citizen earlier this month called on the Obama administration to launch an independent probe into FDA’s lack of action against NECC. The group alleges that FDA already has the authority it needs, but that agency officials failed to take steps that could have prevented the current outbreak

Responding to a Reuters query about Public Citizen’s claims, the Department of Health and Human Services, which oversees FDA, said the agency has limited powers over compounders and urged Congress to strengthen its authority.

SERIOUS CONSEQUENCES

The House Republican report does not say how health officials determined NECC to be a pharmacy instead of a manufacturer. But the decision came after NECC had doubled its production space and begun pursuing a marketing strategy that called for selling compounded drugs to customers in all 50 states.

“It was decided that ‘current findings supported a compounding role’ and that ‘the state would be in a better position to gain compliance or take regulatory action against NECC as necessary’,” said the report.

The decision came at a February 5, 2003 meeting between FDA and state officials that ended with federal regulators emphasizing the potential for “serious public health consequences” if NECC’s compounding practices, in particular those relating to sterile products, did not improve.

“It is noteworthy that after closing out the inspection … FDA’s primary NECC investigator and her supervisor recommended that the ‘firm be prohibited from manufacturing until they can demonstrate ability to make product reproducibly and dependably’.”

Cadden was informed soon after the meeting that FDA did not consider his company to be a manufacturer. On February 26, 2003, he responded in writing to an FDA document calling for corrective measures at NECC by saying: “We are not subject to (nor are we voluntarily subjecting ourselves to) current good manufacturing practices as promulgated by FDA, since we are a compounding pharmacy, not a manufacturer.”

The decision to leave oversight largely to state officials also followed an April 2002 encounter between FDA investigators and Cadden in which the report said the NECC executive challenged the FDA’s authority to be at his pharmacy and refused to provide information or records to the federal agency.

But problems continued at NECC, and the FDA finally issued a warning letter in 2006 warning that the company’s compounding operations had begun to resemble manufacturing operations and still posed potential health risks from the compounding of sterile drugs.

“NECC has a long history of very similar, if not identical, underlying misconduct,” said the congressional report.

“Some of the violations observed by regulators as early as 2002 include the company’s failure to maintain adequate safeguards for sterile injectable products — the very issue at the center of the current meningitis outbreak.”

On Monday, FDA said it discovered insects, a flying bird and other unsanitary conditions at NECC’s sister company, Ameridose LLC. [ID:nL1E8MCDDH]

(Reporting by David Morgan; Editing by Michele Gershberg and Tim Dobbyn)

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Probe shows federal power to access email

WASHINGTON (AP) — Your emails are not nearly as private as you think.

The downfall of CIA Director David Petraeus demonstrates how easy it is for federal law enforcement agents to examine emails and computer records if they believe a crime was committed. With subpoenas and warrants, the FBI and other investigating agencies routinely gain access to electronic inboxes and information about email accounts offered by Google, Yahoo and other Internet providers.

"The government can't just wander through your emails just because they'd like to know what you're thinking or doing," said Stewart Baker, a former assistant secretary at the Department of Homeland Security and now in private law practice. "But if the government is investigating a crime, it has a lot of authority to review people's emails."

Under the 1986 Electronic Communications Privacy Act, federal authorities need only a subpoena approved by a federal prosecutor — not a judge — to obtain electronic messages that are six months old or older. To get more recent communications, a warrant from a judge is required. This is a higher standard that requires proof of probable cause that a crime is being committed.

Public interest groups are pressing Congress for the law to be updated because it was written a quarter-century ago when most emails were deleted after a few months because the cost of storing them indefinitely was prohibitive. Now, "cloud computing" services provide huge amounts of inexpensive storage capacity. Other technological advances, such as mobile phones, have dramatically increased the amount of communications that are kept in electronic warehouses and can be reviewed by law enforcement authorities carrying a subpoena.

"Technology has evolved in a way that makes the content of more communications available to law enforcement without judicial authorization, and at a very low level of suspicion," said Greg Nojeim, a senior counsel at the Center for Democracy & Technology.

The chairman of the Senate Judiciary Committee, Patrick Leahy, has proposed changing the law to require a warrant for all Internet communications regardless of their age. But law enforcement officials have resisted because they said it would undercut their ability to catch criminals.

A subpoena is usually sufficient to require Internet companies to reveal names and any other information that they have that would identify the owner of a particular email account. Google, which operates the widely used Gmail service, complied with more than 90 percent of the nearly 12,300 requests it received in 2011 from the U.S. government for data about its users, according to figures from the company.

Even if a Gmail account is created with a fictitious name, there are other ways to track down the user. Logs of when messages are sent reveal the Internet address the user used to log onto the account. Matching times and dates with locations allow investigators to piece together the chain.

A Gmail account figured prominently in the FBI investigation that led to Petraeus' stunning resignation last week as the nation's spy chief. Petraeus, a retired Army general, stepped down after he confessed to an extramarital affair with Paula Broadwell, an Army Reserve officer and his biographer.

The inquiry began earlier this year after Jill Kelley, a Florida woman who was friends with Petraeus and his wife, Holly, began receiving harassing emails. Kelley is a Tampa socialite. That is where the military's Central Command and Special Operations Command are located.

Petraeus served as commander at Central Command from 2008 to 2010.

FBI agents eventually determined that the email trail led to Broadwell, according to two federal law enforcement officials, who spoke on condition of anonymity because the sources were not authorized to speak about the matter on the record. As they looked further, the FBI agents came across a private Gmail account that used an alias name. On further investigation, the account turned out to be Petraeus's.

The contents of several of the exchanges between Petraeus and Broadwell suggested they were having an affair, according to the officials. Investigators determined that no security breach had occurred, but continued their investigation into whether Petraeus had any role in the harassing emails that Broadwell had sent to Kelley, which was a criminal investigation.

Petraeus and Broadwell apparently used a trick, known to terrorists and teen-agers alike, to conceal their email traffic.

One of the law enforcement officials said they did not transmit all of their communications as emails from one's inbox to the other's inbox. Rather, they composed some emails in a Gmail account and instead of transmitting them, left them in a draft folder or in an electronic "dropbox." Then the other person could log onto the same account and read the draft emails there. This avoids creating an email trail which is easier to trace. It's a technique that al-Qaida terrorists began using several years ago and teen-agers in many countries have since adopted.

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Associated Press writer Pete Yost contributed to this report.

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BBC must reform or die, says Trust chairman

LONDON (Reuters) – The BBC could be doomed unless it makes radical changes, the head of its governing trust said on Sunday, after its director general quit to take the blame for the airing of false child sex abuse allegations against a former politician.

Chris Patten, chairman of the BBC Trust, said confidence had to be restored if the publicly funded corporation was to withstand pressure from rivals, especially Rupert Murdoch‘s media empire, which would try to take advantage of the turmoil.

“If you’re saying, ‘Does the BBC need a thorough structural radical overhaul?’, then absolutely it does, and that is what we will have to do,” Patten, a one-time senior figure in Prime Minister David Cameron‘s Conservative Party and the last British governor of Hong Kong, told BBC television.

“The basis for the BBC’s position in this country is the trust that people have in it,” Patten said. “If the BBC loses that, it’s over.”

George Entwistle resigned as director general on Saturday, just two months into the job, to take responsibility for the child sex allegation on the flagship news programme Newsnight.

The witness in the report, who says he suffered sexual abuse at a care home in the late 1970s, said on Friday he had misidentified the politician, Alistair McAlpine. Newsnight admitted it had not shown the witness a picture of McAlpine, or approached McAlpine for comment before going to air.

Already under pressure after revelations that a long-time star presenter, the late Jimmy Savile, was a paedophile, Entwistle conceded on the BBC morning news that he had not known – or asked – who the alleged abuser was until the name appeared in social media.

The BBC, celebrating its 90th anniversary, is affectionately known in Britain as “Auntie”, and respected around much of the world.

But with 22,000 staff working at eight national TV channels, 50 radio stations and an extensive Internet operation, critics say it is hampered by a complex and overly bureaucratic and hierarchical management structure.

THOMPSON’S LEGACY

Journalists said this had become worse under Entwistle’s predecessor Mark Thompson, who took over in the wake of the last major crisis to hit the corporation and is set to become chief executive of the New York Times Co on Monday.

In that instance, both director general and chairman were forced out after the BBC was castigated by a public inquiry over a report alleging government impropriety in the fevered build up to war in Iraq, leading to major organisational changes.

One of the BBC’s most prominent figures, Newsnight presenter Jeremy Paxman, said since the Iraq report furore, management had become bloated while cash had been cut from programme budgets.

“He (Entwistle) has been brought low by cowards and incompetents,” Paxman said in a statement, echoing a widely-held view that Entwistle was a good man who had been let down by his senior staff.

Prime Minister Cameron appeared ready to give the BBC the benefit of the doubt, believing that “one of the great institutions of this country” could reform and deal with its failings, according to sources in his office.

Patten, who must find a new director general to sort out the mess, agreed that management structures had proved inadequate.

“Apparently decisions about the programme went up through every damned layer of BBC management, bureaucracy, legal checks – and still emerged,” he said.

“One of the jokes I made, and actually it wasn’t all that funny, when I came to the BBC … was that there were more senior leaders in the BBC then there were in the Chinese Communist Party.”

Patten ruled out resigning himself but other senior jobs are expected to be on the line, while BBC supporters fear investigative journalism will be scaled back. He said he expected to name Entwistle’s successor in weeks, not months.

Among the immediate challenges are threats of litigation.

McAlpine, a close ally of former prime minister Margaret Thatcher, has indicated he will sue for damages.

Claims for compensation are also likely from victims who say Savile, one of the most recognisable personalities on British television in the 1960s, 70s and 80s, sexually abused them as children, sometimes on BBC premises.

INQUIRIES

Two inquiries are already under way, looking at failures at Newsnight and allegations relating to Savile, both of which could make uncomfortable reading for senior figures.

Police have also launched a major inquiry into Savile’s crimes and victims’ allegations of a high-profile paedophile ring. Detectives said they had arrested their third suspect on Sunday, a man in his 70s from Cambridgeshire in central England.

Funded by an annual licence fee levied on all TV viewers, the BBC has long been resented by its commercial rivals, who argue it has an unfair advantage and distorts the market.

Murdoch’s Sun tabloid gleefully reported Entwistle’s departure with the headline “Bye Bye Chump” and Patten said News Corp and others would put the boot in, happy to deflect attention after a phone-hacking scandal put the newspaper industry under intense and painful scrutiny.

He said that “one or two newspapers, Mr. Murdoch’s papers” would love to see the BBC lose its national status, “but I think the great British public doesn’t want to see that happen”.

Murdoch himself was watching from afar.

“BBC getting into deeper mess. After Savile scandal, now prominent news program falsely names senior pol as paedophile,” he wrote on his Twitter website on Saturday.

It is not just the BBC and the likes of Entwistle and Patten who are in the spotlight.

Thompson, whom Entwistle succeeded in mid-September, has also faced questions from staff at the New York Times over whether he is still the right person to take one of the biggest jobs in American newspaper publishing.

Britain’s Murdoch-owned Sunday Times queried how Thompson could have been unaware of claims about Savile during his tenure at the BBC as he had told British lawmakers, saying his lawyers had written to the paper addressing the allegations in early September, while he was still director general.

(Editing by Kevin Liffey and Sophie Hares)

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Judy’s Garland’s Oz dress fetches $480K in auction

BEVERLY HILLS, Calif. (AP) — The now-faded blue gingham dress Judy Garland wore in “The Wizard of Oz” has sold for $ 480,000.

Auction house Julien’s Auctions says the pinafore fetched the highest price of any item during a two-day auction of Hollywood memorabilia that attracted bids from around the world. The auction ended Saturday in Beverly Hills, Calif.

Steve McQueen‘s racing jacket sold for $ 50,000, as did a purple skirt worn by Marilyn Monroe while filming “River of No Return” in Canada. Julie Andrews‘ “Sound of Music dress” brought $ 38,400.

Sunglasses worn by Jean Reno in “Leon” went for $ 8,320, while Johnny Depp‘s shades fetched $ 3,250.

Bidders also snapped up pieces of royal wedding cakes. Prince William and Kate Middleton’s cake sold for $ 7,500 while Prince Charles and Princess Diana’s cake sold for $ 1,375.

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Next-day discharge after C-section may be okay: study

(Reuters) – Some women who deliver their babies by cesarean section may be able to check out of the hospital the next day without raising their risk of problems, according to a Malaysian study.

The study, which appeared in the journal Obstetrics & Gynecology, looked at 360 women in Malaysia, who were randomly assigned to go home either one or two days after having a C-section.

Both groups were equally satisfied with their care, and the women who were discharged sooner seemed to have no more problems with breastfeeding or mental well-being.

“Day 1 discharge compared with day 2 discharge after a planned cesarean delivery resulted in equivalent outcomes,” wrote lead author Peng Chiong Tan, at the University of Malaya in Kuala Lumpur.

Those results don’t mean that hospitals should start discharging women the day after a C-section, but they do suggest that a next-day discharge is something women can talk about with their doctors, researchers said.

In the United States, where C-sections are done in about one-third of births, women typically stay in the hospital for three to four days after the procedure. That compares with about two days for women who deliver vaginally.

In the past, there were concerns about insurers pushing mothers to leave the hospital before they’re ready. That led to a 1996 law requiring insurers to pay for a 48-hour hospital stay after a vaginal delivery and a 96-hour stay after a C-section.

Still, the American College of Obstetricians and Gynecologists (ACOG) says a shorter stay after a C-section is an option if the baby is ready to go home, though the mother should meet certain requirements first such as normal blood pressure, no signs of infection and adequate pain control.

At Tan’s hospital in Malaysia, women who have a C-section are routinely told to expect just a two-day stay, and some providers there have discharged new mothers the day after.

Tan’s team randomly assigned the 360 women having a planned C-section to go home either one or two days after delivering. In the end, 16 percent of the women in the day-after group were not discharged that early, because either they or their babies were having problems.

But when they did go home the day after, there didn’t seem to be a greater risk of difficulties. When the women were interviewed two weeks later, 87 percent were happy with their discharge timing.

The same was true for almost 86 percent of women who went home two days after their C-section.

While the findings would likely extend to women in other countries too, these Malaysian women typically went home to a lot of support – often, an extended family network, Tan said.

“Where this support is not available, next-day hospital discharge may not be associated with the same degree of satisfaction, acceptability and good outcome as we have found,” she added.

SOURCE:http://bit.ly/TzbGoz

(Reporting from New York by Amy Norton at Reuters Health; editing by Elaine Lies)

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Obama hails veterans, pledges continued support

ARLINGTON, Virginia (Reuters) - President Barack Obama laid a wreath at the Tomb of the Unknown Soldier to mark the Veterans Day holiday on Sunday, declaring that soldiers' needs would be met even as the country winds down wars in the Middle East and Asia.

In the ceremony at Arlington National Cemetery, Obama pledged continuing support for veterans as they make the transition to civilian life.

"This is the first Veterans Day in a decade in which there are no American troops fighting and dying in Iraq," the president said at the cemetery across the Potomac River from Washington, where soldiers' graves are marked with row upon row of simple white stones.

"After a decade of war, our heroes are coming home," he said. "Over the next few years more than a million service members will transition back to civilian life."

The president touted the work of first lady Michelle Obama and Jill Biden, wife of Vice President Joe Biden, for their work in the Joining Forces campaign, which urges businesses to hire veterans. He also reaffirmed his commitment to continuing the post-9/11 GI Bill program, which provides college education funding for those who have served, and said soldiers suffering war-related health problems will get the care they need.

"No one who fights for this country overseas should ever have to fight for a job, or a roof over their head, or the care that they have earned when they come home," he said.

After the ceremony, Obama visited with people in an area of the cemetery known as Section 60, where many of the solders who died in the Iraq and Afghanistan wars are buried.

The Democratic president won re-election to a second four-year term on Tuesday and now faces tough negotiations with Republican congressional leaders to avoid sharp spending cuts that loom at the end of the year. A big chunk of those reductions would come through a decline in defense spending.

During the campaign, Obama and Biden regularly pledged their commitment to bringing troops home from Afghanistan and taking care of American veterans. Obama criticized his opponent, Republican Mitt Romney, for failing to mention the war in Afghanistan during his speech to the Republican National Convention.

(Reporting by Samson Reiny, writing by Mark Felsenthal; Editing by Doina Chiacu)

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Twin explosions strike southern Syrian city

BEIRUT (AP) — Syria‘s state-run news agency says two large explosions have struck the southern city of Daraa, causing multiple casualties and heavy material damage.

SANA did not immediately give further information or say what the target of Saturday’s explosions was.

The Britain-based Syrian Observatory for Human Rights says the blasts went off near a branch of the country’s Military Intelligence in Daraa.

The Observatory, which relies on a network of activists on the ground, says the explosions were followed by clashes between regime forces and rebels fighting to topple President Bashar Assad.

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Sony Animation preps sequel to hit “Hotel Transylvania”

NEW YORK (TheWrap.com) – Sony Pictures Animation will make a sequel to “Hotel Transylania,” one of the year’s surprise hits, a spokesman for the studio told TheWrap.

Tentatively titled “Hotel Transylvania 2,” the film is set for a 2015 release. There is no director attached at the moment. Genndy Tartakovsky, who directed the first one, will be helming Sony Pictures Animation‘s “Popeye.”

“Hotel Transylvania” opened to $ 42.5 million at the domestic box office and $ 50.6 worldwide, setting a new record for a September opening. It has grossed more than $ 250 million at the global box office so far.

Adam Sandler voiced the character of Dracula, who owns the titular five-star resort designed as a place for monsters to relax away from humans. Other monsters such as Murray the Mummy (Cee Lo Green), Frankenstein’s Monster (Kevin James) and Griffin the Invisible Man (David Spade) descend upon the hotel for the 118th birthday of Dracula‘s daughter Mavis (Selena Gomez).

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FBI probe of Petraeus began with 'suspicious emails'

WASHINGTON (Reuters) - The FBI investigation that led to the discovery of CIA Director David Petraeus' affair with author Paula Broadwell was sparked by "suspicious emails" that initially did not contain any connection to Petraeus, U.S. law enforcement and security officials told Reuters on Saturday.

But the CIA director's name unexpectedly turned up in the course of the investigation, two officials and two other sources briefed on the matter said.

It was "an issue with two women and they stumbled across the affair with Petraeus," a U.S. government security source said.

The Washington Post reported on Saturday that the FBI probe was triggered when Broadwell sent threatening emails to an unidentified woman close to the CIA director.

The woman went to the FBI, which traced the threats to Broadwell and then uncovered explicit emails between Petraeus and Broadwell, the Post said.

Attempts by Reuters and other news media to reach Broadwell, an Army reserve offer and author of a biography of Petraeus, have not been successful.

The FBI and CIA declined comment on Saturday.

Many questions in the case remain unanswered publicly, including the identity of the second woman; the precise nature of the emails that launched the FBI investigation; and whether U.S. security was compromised in any way.

Nor is it clear why the FBI waited until Election Day to tell U.S. Director of National Intelligence James Clapper, who oversees the CIA and other intelligence agencies, about its investigation involving Petraeus.

The CIA director announced his resignation suddenly on Friday, acknowledging an extramarital affair and saying he showed "extremely poor judgment.

The developments likely ended the public career of one of the United States' most highly regarded generals, who was credited with helping pull Iraq out of civil war and led U.S. and NATO troops in Afghanistan.

Meanwhile, new details emerged on Saturday about developments in the final days leading to Petraeus' departure from atop the CIA.

Clapper was notified by the FBI on Tuesday evening about 5 p.m. - just as returns in the U.S. presidential election were about to come in - about "the situation involving Director Petraeus," a senior intelligence official said. Clapper and Petraeus then spoke that evening and the following morning.

WHITE HOUSE NOTIFIED WEDNESDAY

"Director Clapper, as a friend and a colleague and a fellow general officer, advised Director Petraeus that he should do the right thing and he should step down," the official said.

Clapper is a retired Air Force lieutenant general; Petraeus served nearly four decades in the U.S. Army.

On Wednesday, Clapper notified the National Security Council at the White House that Petraeus was considering resigning and President Barack Obama should be informed, the official said.

U.S. law enforcement and intelligence officials agreed to discuss the Petraeus matter only on condition of anonymity because of the issue's sensitivity and because it is the subject of a law enforcement investigation.

Once Petraeus' name turned up in the investigation, the importance of the FBI inquiry was immediately escalated, as investigators became concerned the CIA chief somehow might have been compromised, the law enforcement official said.

However, the official and two sources briefed on the matter said no evidence has turned up suggesting Petraeus had become vulnerable to espionage or blackmail. At this point, it appears unlikely that anyone will be charged with a crime as a result of the investigation, the official said.

The FBI investigation began fairly recently - months ago rather than years ago, when Petraeus would still have been in uniform as one of the U.S. Army's top field commanders, the official said.

Representative Peter King, Republican chairman of the House of Representatives' Homeland Security Committee, said in an interview on MSNBC the FBI was "investigating or monitoring ... the director of the CIA for four or five months."

Several officials briefed on the matter said senior officials at the Pentagon, CIA and Congress knew nothing of the FBI's investigation of Petraeus until Thursday afternoon at the earliest, and some key officials were not briefed on the details until Friday.

There is no evidence at this time that anyone at the White House had knowledge of the situation involving Petraeus prior to the U.S. presidential election on Tuesday, which saw Obama elected to a second four-year term.

Another U.S. government security source said it was not until Friday afternoon that some members of the House and Senate intelligence oversight committees were notified about Petraeus' resignation by Clapper's office.

The congressional committees were told that it was a personal issue that Petraeus had to discuss with his wife. When pressed, a representative of the Office of the Director of National Intelligence said it involved another woman.

(Writing by Warren Strobel; Additional reporting by Doug Palmer and Matt Spetalnick; Editing by Todd Eastham)

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Syria opposition bloc elects Christian as leader

DOHA, Qatar (AP) — Syria‘s main opposition group in exile has elected a Christian Paris-based former geography teacher as its new president.

George Sabra said Friday that his election as head of the Syrian National Council is a sign that the opposition is not plagued by sectarian divisions.

Sabra says the SNC‘s main demand is to receive weapons from the international community. The U.S. and some other foreign backers of rebels fighting the regime of President Bashar Assad have so far refused to send weapons for fear they can fall into the wrong hands.

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