About New York: One Boy’s Death Moves State to Action to Prevent Others





Prompted by the death of a 12-year-old Queens boy in April, New York health officials are poised to make their state the first in the nation to require that hospitals aggressively look for sepsis in patients so treatment can begin sooner. Under the regulations, which are now being drafted, the hospitals will also have to publicly report the results of their efforts.




The action by New York has elated sepsis researchers and experts, including members of a national panel who this month formally recommended that the federal government adopt standards similar to what the state is planning.


Though little known, sepsis, an abnormal and self-destructive immune response to infection or illness, is a leading cause of death in hospitals. It often progresses to severely low blood pressure, shock and organ failure.


Over the last decade, a global consortium of doctors, researchers, hospitals and advocates has developed guidelines on early identification and treatment of sepsis that it says have led to significant drops in mortality rates. But first hints of the problem, like a high pulse rate and fever, often are hard for clinicians to tell apart from routine miseries that go along with the flu or cold.


“First and foremost, they need to suspect sepsis,” Dr. Mitchell M. Levy, a professor at Brown University School of Medicine and a lead author of a paper on the latest sepsis treatment guidelines to be published simultaneously next month in the United States in a journal, Critical Care Medicine, and in Europe in Intensive Care Medicine.


“It’s the most common killer in intensive care units,” Dr. Levy said. “It kills more people than breast cancer, lung cancer and stroke combined.”


If started early enough, the treatment, which includes antibiotics and fluids, can help people escape from the drastic vortex of sepsis, according to findings by researchers working with the Surviving Sepsis Campaign, the global consortium. The tactics led to a reduction of “relative risk mortality by 40 percent,” Dr. Levy said.


Although studies of 30,000 patients show that the guidelines save lives, “the problem is that many hospitals are not adhering to them,” said Dr. Clifford S. Deutschman, director of the sepsis research program at the Perelman School of Medicine at the University of Pennsylvania and the president of the Society of Critical Care Medicine.


About 300 hospitals participate in the study, and the consortium has a goal of having 10,000. “The case is irrefutable: if you take these sepsis measures, and you build a program to help clinicians and hospitals suspect sepsis and identify it early, that will mean more people will survive,” Dr. Levy said.


At a symposium in October, the New York health commissioner, Dr. Nirav R. Shah, said that he would require state hospitals to adopt best practices for early identification and treatment of sepsis. Gov. Andrew M. Cuomo intends to make it a major initiative in 2013, said Josh Vlasto, a spokesman for the governor. “The state is taking unprecedented measures to prevent and effectively treat sepsis in health care facilities across the state and is looking at a wide range of additional measures to better protect patients,” Mr. Vlasto said.


In April, Rory Staunton, a sixth grader from Queens, died of severe septic shock after he became infected, apparently through a cut he suffered while playing basketball. The severity of his illness was not recognized when he was treated in the emergency room at NYU Langone Medical Center. He was sent home with a diagnosis of an ordinary bellyache. Hours later, alarming laboratory results became available that suggested he was critically ill, but neither he nor his family was contacted. For an About New York column in The New York Times, Rory’s parents, Ciaran and Orlaith Staunton, publicly discussed their son’s final days. Their revelations prompted doctors and hospitals across the country to seek new approaches to heading off medical errors.


In addition, Commissioner Shah in New York convened a symposium on sepsis, which included presentations from medical experts and Rory’s parents.


At the end of the meeting, Dr. Shah said that he had listened to all the statistics on the prevalence of the illness, and that one had stuck in his memory: “Twenty-five percent,” he said — the portion of the Staunton family lost to sepsis.


He said he would issue new regulations requiring hospitals to use best practices in identifying and treating sepsis, actions that, he said, he was taking “in honor of Rory Staunton.”


The governor’s spokesman, Mr. Vlasto, said that “the Staunton family’s advocacy has been essential to creating a strong public will for action.”


Dr. Levy said New York’s actions were “bold, pioneering and grounded in good scientific evidence,” adding, “The commissioner has taken the first step even before the federal government.”


Dr. Deutschman said that initiatives like those in New York were needed to overcome resistance among doctors. “You’re talking about a profession that has always prided itself on its autonomy,” he said. “They don’t like to be told that they’re wrong about something.”


The availability of proven therapies should move treatment of sepsis into a new era, experts say, comparing it to how heart attacks were handled not long ago. People arriving in emergency rooms with chest pains were basically put to bed because not much could be done for them, said Dr. Kevin J. Tracey, the president of the Feinstein Institute for Medical Research at North Shore-Long Island Jewish Health System. Dr. Tracey, a neurosurgeon, has made major discoveries about the relationship between the nervous system and the runaway immune responses of sepsis.


If physicians and nurses were trained to watch for sepsis, as they now routinely do for heart attacks, many of its most dire problems could be headed off before they got out of control, he said. The Stauntons have awakened doctors and nurses to the possibility of danger camouflaged as a stomach bug.


“We are with sepsis where we were with heart attack in the early 1980s,” Dr. Tracey said.


“If you don’t think of it as a possibility, this story can happen again and again. This case could change the world.”


E-mail: dwyer@nytimes.com


Twitter: @jimdwyernyt



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As Shoppers Hop From Tablet to PC to Phone, Retailers Try to Adapt


Ryan O’Neil, a Connecticut government employee, was in the market to buy a digital weather station this month. His wife researched options on their iPad, but even though she found the lowest-price option there, Mr. O’Neil made the purchase on his laptop.


“I do use the iPad to browse sites,” Mr. O’Neil said, but when it comes time to close the deal, he finds it easier to do on a computer.


Many online retailers had visions of holiday shoppers lounging beneath the Christmas tree with their mobile devices in hand, making purchases. The size of the average order on tablets, particularly iPads, tends to be bigger than on PCs. So retailers poured money and marketing into mobile Web sites and apps with rich images and, they thought, easy checkout.


But while visits to e-commerce sites and apps on tablets and phones have nearly doubled since last year, consumers like Mr. O’Neil are more frequently using multiple devices to shop. In many cases, they are more comfortable making the final purchase on a computer, with its bigger screen and keyboard. So retailers are trying to figure out how to appeal to a shopper who may use a cellphone to research products, a tablet to browse the options and a computer to buy.


“I’ve been yelling at customers for two years, saying, ‘Mobile, mobile, mobile,’ ” said Jason Spero, director of mobile sales and strategy at Google. “But the funny thing is, now we’re going to say: ‘Don’t put mobile in a silo. It’s also about the desktop.’ ”


The challenges are daunting, though. It is technically difficult to track consumers as they hop from phone to computer to tablet and back again. This means customers who, say, fill shopping carts on their tablets have to do all the work again on their PCs or other devices. The biggest obstacle, retailers say, is that the tools used to track shoppers on computers — cookies, or bundles of data stored in Web browsers — don’t transfer across devices.


Instead, retailers are figuring out how to sync the experience in other ways, like prompting shoppers to log in on each device. And being able to track people across devices gives retailers more insight into how they shop.


The retailers’ efforts are backed by research. While one-quarter of the visits to e-commerce sites occur on mobile devices, only around 15 percent of purchases do, according to data from I.B.M. According to Google, 85 percent of online shoppers start searching on one device — most often a mobile phone — and make a purchase on another.


At eBags, customers are shopping on their tablets in the evening and returning on their work computers the next day. But eBags has not yet synced the shoppers across devices, so customers must build their shopping carts from scratch if they switch devices.


“That is a blind spot with a lot of sites,” said Peter Cobb, co-founder of eBags. “It is a requirement moving forward.”


At eBay, one-third of the purchases involve mobile devices at some point, even if the final purchase is made on a computer.


At eBay, once shoppers log in on a device, they do not need to log in again. Their information, like shipping and credit card details and saved items, syncs across all their devices. If an eBay shopper is interested in a certain handbag, and saves that search on a computer, eBay will send alerts to her cellphone when a new handbag arrives or an auction is about to end.


“They might discover an item on a phone or tablet, do a saved-search push alert later on some other screen and eventually close on the Web site,” said Steve Yankovich, who runs eBay Mobile. “People are buying and shopping and consuming potentially every waking moment of the day.”


ModCloth, an e-commerce site for women’s clothes, said that while a quarter of its visits come from mobile devices, people are not yet buying there in the same proportion, though they are becoming more comfortable with checking out on those devices.


“She’s visiting us more on the phone, but she’s actually transacting somewhere else,” said Sarah Rose, vice president of product at ModCloth.


For example, a shopper will skim through new arrivals on her phone while on the bus and add items to her wish list, then visit that evening on her tablet to make a purchase, Ms. Rose said.


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Boehner rejects Democrats' push for immediate vote on gun bill









WASHINGTON -- House Speaker John A. Boehner rejected calls from Democrats to schedule a vote on new gun restrictions before the end of the year, saying he wants to wait for recommendations from a newly formed White House task force before committing to a legislative response to the mass shooting at a Connecticut school.

“When the vice president's recommendations come forward, we'll certainly take them into consideration,’’ Boehner (R-Ohio) said Thursday in his first public comments on calls for new gun legislation since the slaying of 20 students and six adults at Sandy Hook Elementary School. “But at this point I think our hearts and souls ought to be to think about those victims in this horrible tragedy.”


President Obama on Wednesday said he had asked Vice President Joe Biden to lead a task force to come up with initiatives to stem gun violence by the end of next month. House Democratic Leader Nancy Pelosi of San Francisco and fellow Democrats have pressed for an immediate vote on a long-stalled bill that would ban ammunition magazines containing more than 10 rounds.





Obama has outlined a slightly slower pace for action, urging Congress to hold a vote “in a timely manner” in the new year.


Both Obama and Democrats on Capitol Hill say they are trying to seize on what appears to be a burst of momentum behind gun legislation in the wake of the Newtown, Conn., tragedy. Similar efforts initiated after other high-profile shootings faltered after national attention veered elsewhere.


Biden held the first meeting of the task force Thursday, gathering several cabinet members and White House officials with a group of local law enforcement leaders. In remarks before the meeting, the vice president noted his work on the 1994 crime bill, which banned the sale of some assault weapons, and said he would again be working closely with police groups to craft proposals.


“What I think the public has learned about you is you have a much more holistic view of how to deal with violence on our streets and in our country that you’re ever given credit for,” Biden told the law enforcement officials. “I want to hear your views because, for anything to get done, we’re going to need your advocacy.”


richard.simon@latimes.com


Twitter: @richardsimon11


kathleen.hennessey@latimes.com


Twitter: @khennessey





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Net Neutrality, Data-Cap Legislation Lands in Senate



A proposal forbidding internet service providers from turning the data-cap meter off to grant a so-called internet fast lane to preferential online services was introduced Thursday in the Senate.


The bill by Sen. Ron Wyden (D-Oregon) comes a week after a report found that the institutionalization of data caps by ISPs is geared toward profiteering rather than the stated goal of managing traffic congestion.


“A covered internet service provider may not, for purposes of measuring data usage or otherwise, provide preferential treatment of data that is based on the source or the content of the data,” (.pdf) Wyden’s bill reads.


Ars Technica noted that Comcast had not counted its Xbox video-streaming app against its data caps. Comcast, however, no longer enforces its data caps.


“Data caps create challenges for consumers and run the risk of undermining innovation in the digital economy if they are imposed bluntly and not designed to truly manage network congestion,” Wyden said in a statement.


Among other things, the proposal demands a standardized method for measuring data and also questions data caps altogether. That’s because it grants the Federal Communications Commission with regulatory power over data-cap pricing.


“The commission shall evaluate a data cap proposed by an internet service provider to determine whether the data cap functions to reasonably limit network congestion in a manner that does not unnecessarily discourage use of the internet,” according to the proposal.


That means internet companies might have to explain why the caps are imposed at low-traffic times, such as in the middle of the night.


The proposal was immediately applauded by the digital rights group Public Knowledge.


“Data caps create an artificial scarcity in the broadband market that limits consumer choice and hinders the creation of new competitive content online,” Christopher Lewis, the group’s vice president, said in a statement.


For the moment, the proposal is going nowhere as lawmakers are expected to adjourn for the year in the coming days.



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World Music Awards postponed due to visa issues, Newtown tragedy






LOS ANGELES (Reuters) – The World Music Awards was postponed on Thursday due to “logistical and multiple visa issue,” organizers said, two days before the event was scheduled to be held in Miami.


Event producers John Martinotti and Marcol International said in a statement that the December 22 awards ceremony also was being delayed in the wake of the elementary school shooting in Newtown, Connecticut, last week.






“We are sorry for any inconvenience but this decision had to be made due to logistical and multiple visa issues and in view of this week’s national mourning. Fans have been a great support to the artists and have voted online in huge numbers,” the producers said in a statement.


The winners in categories ranging from world’s best song, world’s best artists and entertainer of the year, are picked by fans who vote online. The statement said that votes will continue to be collected until a new date is set for the show.


This year’s nominees include Usher, Justin Bieber, Nicki Minaj, Rihanna and Chris Brown. Past winners include Whitney Houston, Mariah Carey and Michael Jackson.


The awards ceremony, founded in 1989 and hosted by Monaco’s Prince Albert II, has primarily taken place in Monte Carlo and proceeds from the show go to charity. This year, show producers decided to move it to Marlins Park Stadium in Miami.


(Reporting By Piya Sinha-Roy, editing by Eric Kelsey)


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Obama makes gun control top priority









WASHINGTON — President Obama committed himself to placing gun control at the top of his second-term agenda, redoubling his intention to tackle the problem of gun violence in spite of daunting political obstacles that have frustrated similar efforts for years.


Appearing before reporters in the White House briefing room Wednesday, Obama sought to erase any doubts that he is prepared to stake his prestige on combating what he called an "epidemic of gun violence." Although he spoke in the aftermath of the massacre last Friday at a Connecticut elementary school, he placed the issue in a broader context, specifically mentioning people killed since then in the "lesser-known tragedies that visit small towns and big cities all across America every day."


As a first step, Obama gave Vice President Joe Biden the task of coming up with specific proposals before the end of next month. Working with Cabinet members and outside organizations, Biden is to come up with ideas that probably will include actions Obama can take administratively to bypass potential clashes with Congress.





The working group is expected to examine not only proposals for gun control measures, but also steps to improve services for the mentally ill and to push back against violence in popular culture.


Obama promised that he would detail "very specific" initiatives early next year, including in his State of the Union address, and sought to rebut the idea that Biden's group would be another ineffective Washington commission.


Biden has long experience with the politics of gun control from his service as the head of the Senate Judiciary Committee during the 1980s and 1990s. But neither his familiarity with the issue nor Obama's determination to press forward changes the extremely difficult nature of the fight that lies ahead for them.


In many respects, the climate for congressional action is less favorable than it was in 1994, when President Clinton's exhaustive personal lobbying campaign for a ban on assault-style weapons managed to prevail in a House of Representatives that Democrats controlled by two votes.


Despite an uptick in the aftermath of the latest tragedy, public support for stricter gun control laws remains significantly lower today than in the 1990s, according to polls.


"The politics are absolutely gruesome," said Paul Begala, a former Clinton advisor who worked to reelect Obama in 2012. "In many areas, the country is moving left, certainly in terms of gay rights, and on issues like marijuana. But from the time I was working with President Clinton, we've moved significantly to the right on gun control."


Patrick J. Griffin, a Clinton White House aide who was at the center of the fight over the 1994 crime bill, called it "probably tougher than healthcare" to get through Congress.


A handful of pro-gun-rights Democrats have stepped forward this week to suggest the need for tougher gun laws or at least a need for what Sen. Joe Manchin III of West Virginia called "a conversation on everything."


Republicans, however, have largely remained silent, making the Republican-controlled House of Representatives a particular stumbling block.


Asked whether GOP lawmakers would soon speak out in favor of tighter laws, Republican strategist Whit Ayres said no, "because they don't believe that more gun laws are likely to stop gun violence committed by mentally ill people."


Obama alluded to the daunting legislative math he faces by noting that many House Republicans represent districts that GOP presidential nominee Mitt Romney won last month. Indeed, a majority of the new House — 219 representatives out of 435 — will be Republicans from districts that Obama failed to carry, noted David Wasserman of the Cook Political Report.


In his remarks, Obama pledged to push ahead regardless of that political arithmetic. "The fact that this problem is complex can no longer be an excuse for doing nothing," he said.


He called on the new Congress to vote "in a timely manner" on banning the sale of assault-style weapons and high-capacity ammunition clips and on a requirement for background checks before all gun purchases. Those proposals, which Sen. Dianne Feinstein (D-Calif.) and others plan to introduce as early as next month, have repeatedly been blocked in Congress by the gun lobby and its allies.


The president also said the Senate should confirm a permanent director of the Bureau of Alcohol, Tobacco, Firearms and Explosives, a position that has been filled on an interim basis over the last six years because of opposition from gun rights forces.


Obama did not preview how he might try to prod reluctant lawmakers, but employing the memory of the Sandy Hook Elementary School shooting victims will probably be one technique.


Progress could be made "if those of us who were sent here to serve the public trust can summon even one tiny iota of the courage those teachers, that principal, in Newtown summoned on Friday," he said.


At one point, a reporter suggested that the president had essentially been absent from the gun control fight over the last four years, through repeated episodes of mass gun violence.





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Thingiverse Removes (Most) Printable Gun Parts



In the wake of the Sandy Hook shooting, Thingiverse is cracking down on 3-D printable gun parts.


When the team at Wiki Weapon set the internet on fire by announcing a 3-D printable gun, what they’d actually accomplished was creating a barely working part for an AR-15 assault rifle, the same gun platform that Adam Lanza used in Sandy Hook Elementary. The plans for that part were available through yesterday on Thingiverse MakerBot’s repository for 3-D printable plans. Today, the files have been taken down.

The AR-15 part had been uploaded by gunsmith Michael Guslick, who goes by HaveBlue on the site. The part has been available since before Thingiverse changed its terms of service to forbid weapons and weapon parts.


Thingiverse’s latest Terms of Service say, “You agree not to use the Site or Services to collect, upload, transmit, display, or distribute any User Content … (ii) that … promotes illegal activities or contributes to the creation of weapons.”


In a statement obtained by CNET, MakerBot’s attorney said that “Thingiverse has always been, and is currently, evolving … as is the company as it pursues innovation and growth. We have always had the discretion to take action for policy violations. Recent events served as the impetus here to take immediate action (and there were several) and reiterate or emphasize the site’s focus on creative empowerment for products that have a positive impact.”



Policing those terms of service is a challenging task, and a quick search reveals several borderline cases that remain online.


There is a custom grip for the Ruger LCP pistol uploaded by user Pawl. One user who has printed the part indicates that it has a tendency for the clip attaching it to the gun to break off, while another asks for a version then can be re-sized for a Glock.


User jballard‘s projects include blueprints for an M-16 Receiver and a Colt M1911A1 Pistol, along with a Picatinny Rail iPhone Mount. “With this Iphone mount you will no longer miss a text or a call while you are hunting, ‘plinking,’ or just having a good ol time!” reads the description, “I have shown it mounted to the top of an AR-15 Reciever, it can also be mounted on the botom of pistol rails and any other type of picatinny accesory rails you can find!”


Jballard seems aware of the line they are toeing, because they also offer a Weaponized Fork. “This is a fork. You can eat with it. You can stab things with it. You can launch it with a device made to launch such objects. This thing has changed the world, can you?”


Meanwhile, there are a lot of prop weapons like this revolver from user Renosis, and a galaxy of plans for Nerf weapons and attachments (including a Nerf claymore).


The link between DIYers and gun enthusiasm runs deep. As Christopher Mims reports, the AR-15 that Lanza used isn’t so much a gun as a highly customizable weapon platform and a consumer toy with a whole industry of aftermarket parts and DIY upgrades.


For a glimpse into that world, you can visit AR15.com, which features a thread with close to 4,000 posts of members swapping photos of their beloved weapon with the most recent additions having been made today.


A tour through that thread reveals a culture of guns fandom that is as wide as America. There are guns with Star Wars insignia, guns with jokes about the zombie apocalypse, pink guns, minimalist machined guns, and baroque monsters covered in bells and whistles and laser sights. Each one was lovingly built and detailed with the same care given to modding a hot rod, custom-building a PC, or creating a 3-D printed Yoda head.



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Music, roses at singer Jenni Rivera’s memorial






UNIVERSAL CITY, Calif. (AP) — Jenni Rivera‘s “celestial graduation” was marked by festive music, heartfelt speeches in Spanish and English and passionate chants of “Jen-ni! Jen-ni!”


Rivera’s children and famed singers Olga Tanon and Joan Sebastian performed during the nearly 2 ½-hour memorial service Wednesday at the Gibson Amphitheatre, where thousands of fans gathered to salute the “Diva de la Banda” who died in a plane crash Dec. 9.






One fan, Veronika Flores, drove nearly eight hours from her home in Woodland, Calif., near Sacramento, to be united with other fans at the service.


“I just came to say goodbye to a Latina woman, La Gran Senora,” she said, invoking the name of one of Rivera’s most beloved songs.


Famed Mexican singers Marco Antonio Solis and Ana Gabriel and actors Lou Diamond Phillips and Kate del Castillo were also among the guests at Wednesday’s service.


A red casket sat onstage amid a sea of white roses as images of Rivera played on three big screens. Family members embraced and kissed the casket at the conclusion of the service, laying more white roses atop it.


While most of the speeches and songs were delivered in Spanish, Rivera’s children spoke in English, often directly to their late mother.


“We’re not here to mourn the death,” said son Michael, 21. “We’re here to celebrate the life and graduation of a singer, an entertainer, a diva, a fighter, an entrepreneur, a philanthropist, and more than anything, a mother — the best mother.”


He then called for 27 seconds of silence for the victims of the massacre in Newtown, Conn.


Rivera’s youngest child, 11-year-old Johnny, was heartbreakingly poised as he said, “The person that everyone’s talking about is my mom.”


“Mama, I’ve been crying so much these last few days. I miss you so much,” said the little boy, wearing a red bow tie like many of his family members. “I hope you’re taking care of my dad and I hope he’s taking care of you, too.”


Rivera’s second husband, Juan Lopez, died in 2009. The couple divorced in 2003.


Rivera’s brothers and sisters spoke lovingly of the singer, calling her “the queen of queens,” ”perfectly imperfect” and an “eternal diva.” Her father said Rivera’s “happiness, smile and care for the public will never be forgotten.” He then performed a song he wrote about his daughter, a woman who rose from humble roots to become “la Diva de la Banda.”


One of Rivera’s brothers said his sister “made it OK for women to be who they are. Jenni also made it OK to be from nothing with the hopes of being something.”


The family asked that Latin radio stations play Rivera’s song “La Gran Senora” at noon Thursday in her honor.


The service was closed to most media, although a broadcast of the proceedings was made available.


The burial will be private.


Rivera’s last album before her death, “La Misma Gran Senora,” topped the Latin albums chart this week, selling 27,000 copies — the best sales week for any Latin album this year. Rivera also holds three spots on the Billboard 200 albums chart.


Rivera and six other people died Dec. 9 in a northern Mexico plane crash that remains under investigation. Rivera, a mother of five children and grandmother of two, was 43.


Rivera sold more than 15 million copies of her 12 major-label albums. Her soulful singing style and honesty about her tumultuous personal life won her fans on both sides of the U.S.-Mexico border. She was also an actress and reality TV star.


Born in Los Angeles, Rivera launched her career by selling cassette tapes at flea markets. By the end of the 90s, she won a major-label contract and built a loyal following.


Many of her songs deal with themes of dignity in the face of heartbreak, which Rivera spoke of openly with her fans.


She had recently filed for divorce from her third husband, was once detained at a Mexico City airport with tens of thousands of dollars in cash, and publicly apologized after her brother assaulted a drunken fan who verbally attacked her in 2011.


“She was a fighter, a woman who can push boundaries,” said Flores. “That’s why I liked her, because I’m just like her.”


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F.D.A. and States Meet About Regulation of Drug Compounders


Mary Calvert/Reuters


Margaret Hamburg, the F.D.A. commissioner, testified on the meningitis outbreak before Congress in November. She addressed the need for greater federal oversight of large compounding pharmacies, which mix batches of drugs on their own, often for much lower prices than major manufacturers charge.







SILVER SPRING, Md. – The Food and Drug Administration conferred with public health officials from 50 states on Wednesday about how best to strengthen rules governing compounding pharmacies in the wake of a national meningitis outbreak caused by a tainted pain medication produced by a Massachusetts pharmacy.




It was the first public discussion of what should be done about the practice of compounding, or tailor-making medicine for individual patients, since the F.D.A. commissioner, Dr. Margaret Hamburg, testified in Congress last month about the need for greater federal oversight of large compounding pharmacies. So far, 620 people in 19 states have been sickened in the outbreak, and 39 of them have died.


Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how the states see the federal role. Some states said they would prefer to see the F.D.A. handle large-scale compounders like the New England Compounding Center, or N.E.C.C., the Massachusetts pharmacy that was the source of the outbreak.


“The consensus in our group was that there is a role for the F.D.A. to be involved in facilities like N.E.C.C.,” said Cody Wiberg, the executive director of the Minnesota Board of Pharmacy. “If you’re talking about compounding, most states have the authority and resources to handle that. If you’re talking about nontraditional compounding,” he said, referring to large-scale enterprises like N.E.C.C., “fewer states may have the resources to do that.”


Large-scale compounding has expanded drastically since the early 1990s, driven by changes in the health care system, including the rise of hospital outsourcing.


“It is very clear that the health care system has evolved and the role of the compounding pharmacies has really shifted,” Dr. Hamburg said in a telephone interview on Tuesday. She said the laws had not kept pace.


“We need legislation that reflects the current environment and the known gaps in our state and federal oversight systems,” Dr. Hamburg said.


Under current law, compounders are not required to give the F.D.A. access to their books, and about half of all the court orders the agency obtained over the past decade were for pharmacy compounders, although compounders are only a small part of the agency’s regulatory responsibilities.


The F.D.A.'s critics argue that the agency already has all the legal authority it needs to police compounders. They say that many compounders have been operating as major manufacturers, shipping to states across the country, and that the F.D.A. should be using its jurisdiction over manufacturers to regulate those companies’ activities.


“There should be one uniform federal standard that is enforced by one agency – the F.D.A.,” said Michael Carome, deputy director of Public Citizen’s Health Research Group, a nonprofit consumer organization, who has been a critic of the agency’s approach. “They have been lax in enforcing that standard.”


But Dr. Hamburg contends that the distinction is not so simple. Lumping large compounders in with manufacturers would mean they would have to file new drug applications for every product they make, a costly and time-consuming process that is not always necessary for the products they make, like IV feeding tube bags, for example. Dr. Hamburg has proposed creating a new federal oversight category for large-scale compounders, separate from manufacturers.


“What concerns me is the idea that we could assert full authority over some of these facilities as though they were manufacturers, as though there were an on-off, black-white option,” Dr. Hamburg said. “That is a heavy-handed way to regulate a set of activities that can make a huge positive difference in providing necessary health care to people.”


The central problem, state representatives said, is how to define large-scale compounding. Should companies be measured by how much they produce, whether they ship across state lines, the types of products they produce, or some combination of those factors?


“It’s easy to stand at a distance and ask why can’t there be a bright line?” said Jay Campbell, executive director of the North Carolina Board of Pharmacy. “Let’s not let the perfect get in the way of the good. We won’t be able to make a distinction that is razor sharp.”


Large-scale compounders play an important role in the health care supply chain when they produce high-quality products, F.D.A. officials say. They fill gaps during shortages and supply hospitals with products that can be made more safely and cost-effectively in bulk than in individual hospitals.


Officials said they wanted to make sure the products made by such suppliers were safe, but were also concerned about disrupting that supply.


Carmen Catizone, head of the National Association of Boards of Pharmacy, said that states were not equipped to regulate the large-scale compounders and that the F.D.A. needed to find a middle path for regulating them.


“Either hospitals are not going to like the solution, or the manufacturers aren’t going to like the fact that these guys get a shorter path,” he said. “But something’s got to give.”


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State of the Art: Android Cameras From Nikon and Samsung Go Beyond Cellphones - Review




60 Seconds With Pogue: Android Cameras:
David Pogue reviews the Nikon Coolpix S800C and the Samsung Galaxy Camera.







“Android camera.” Wow, that has a weird ring, doesn’t it? You just don’t think of a camera as having an operating system. It’s like saying “Windows toaster” or “Unix jump rope.”




But yes, that’s what it has come to. Ever since cellphone cameras got good enough for everyday snapshots, camera sales have been dropping. For millions of people, the ability to share a fresh photo wirelessly — Facebook, Twitter, e-mail, text message — is so tempting, they’re willing to sacrifice a lot of real-camera goodness.


That’s an awfully big convenience/photo-quality swap. A real camera teems with compelling features that most phones lack: optical zoom, big sensor, image stabilization, removable memory cards, removable batteries and decent ergonomics. (A four-inch, featureless glass slab is not exactly optimally shaped for a hand-held photographic instrument.)


But the camera makers aren’t taking the cellphone invasion lying down. New models from Nikon and Samsung are obvious graduates of the “if you can’t beat ’em, join ’em” school. The Nikon Coolpix S800C ($300) and Samsung’s Galaxy Camera ($500 from AT&T, $550 from Verizon) are fascinating hybrids. They merge elements of the cellphone and the camera into something entirely new and — if these flawed 1.0 versions are any indication — very promising.


From the back, you could mistake both of these cameras for Android phones. The big black multitouch screen is filled with app icons. Yes, app icons. These cameras can run Angry Birds, Flipboard, Instapaper, Pandora, Firefox, The New York Times, GPS navigation programs and so on. You download and run them exactly the same way. (That’s right, a GPS function. “What’s the address, honey? I’ll plug it into my camera.”)


But the real reason you’d want an Android camera is wirelessness. Now you can take a real photo with a real camera — and post it or send it online instantly. You eliminate the whole “get home and transfer it to the computer” step.


And as long as your camera can get online, why stop there? These cameras also do a fine job of handling Web surfing, e-mail, YouTube videos, Facebook feeds and other online tasks. Well, as fine a job as a phone could do, anyway.


You can even make Skype video calls, although you won’t be able to see your conversation partner; the lens has to be pointing toward you.


Both cameras get online using Wi-Fi hot spots. The Samsung model can also get online over the cellular networks, just like a phone, so you can upload almost anywhere.


Of course, there’s a price for that luxury. Verizon charges at least $30 a month if you don’t have a Verizon plan, or $5 if you have a Verizon Share Everything plan. AT&T charges $50 a month or more for the camera alone, or $10 more if you already have a Mobile Share plan.


If you have a choice, Verizon is the way to go. Not only is $5 a month much more realistic than $10 a month, but Verizon’s 4G LTE network is far faster than AT&T’s 4G network. That’s an important consideration, since what you’ll mostly be doing with your 4G cellular camera is uploading big photo files. (Wow. Did I just write “4G cellular camera?”)


These cameras offer a second big attraction, though: freedom of photo software. The Android store overflows with photography apps. Mix and match. Take a shot with one app, crop, degrade and post it with Instagram.


Just beware that most of them are intended for cellphones, so they don’t recognize these actual cameras’ optical zoom controls. Some of the photo-editing apps can’t handle these cameras’ big 16-megapixel files, either. Unfortunately, you won’t really know until you pay the $1.50 or $4 to download these apps.


E-mail: pogue@nytimes.com



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