Drug Shortages Are Becoming Persistent in U.S.


Paul Davis, the chief of a rural ambulance squad in southern Ohio, was down to his last vial of morphine earlier this fall when a woman with a broken leg needed a ride to the hospital.


The trip was 30 minutes, and the patient was in pain. But because of a nationwide shortage, his morphine supply had dwindled from four doses to just one, presenting Mr. Davis with a stark quandary. Should he treat the woman, who was clearly suffering? Or should he save it for a patient who might need it more?


In the end, he opted not to give her the morphine, a decision that haunts him still. “I just feel like I’m not doing my job,” said Mr. Davis, who is chief of the rescue squad in Vernon, Ohio. He has since refilled his supply. “I shouldn’t have to make those kinds of decisions.”


From rural ambulance squads to prestigious hospitals, health care workers are struggling to keep vital medicines in stock because of a drug shortage crisis that is proving to be stubbornly difficult to fix. Rationing is just one example of the extraordinary lengths being taken to address the shortage, which health care workers say has ceased to be a temporary emergency and is now a fact of life. In desperation, they are resorting to treating patients with less effective alternative medicines and using expired drugs. The Cleveland Clinic has hired a pharmacist whose only job is to track down hard-to-find drugs.


Caused largely by an array of manufacturing problems, the shortage has prompted Congressional hearings, a presidential order and pledges by generic drug makers to communicate better with federal regulators.


The problem peaked in 2011, when a record 251 drugs were declared in short supply. This year, slightly more than 100 were placed on the list, and workers say the battle to keep pharmacy shelves stocked continues unabated. The list of hard-to-find medicines ranges from basic drugs like the heart medicine nitroglycerin to a lidocaine injection, which is used to numb tissue before surgery.


A deadly meningitis outbreak caused by contamination at a large drug producer could worsen the situation, federal officials have warned. The Food and Drug Administration said that shortages of six drugs — medicines used during surgery and to treat conditions like congestive heart failure — could get worse after a big compounding pharmacy closed over concerns about drug safety. The pharmacy, Ameridose, shares some management with the New England Compounding Center, which is at the center of a meningitis outbreak that has claimed 33 lives.


“When you can’t treat basic things — cardiac arrest, pain management, seizures — you’re in trouble,” said Dr. Carol Cunningham, the state medical director for the Ohio Department of Public Safety’s emergency services division. “When you only have five tools in your toolbox and three of them are gone, what do you do?”


Dr. Margaret A. Hamburg, the F.D.A. commissioner, said in an interview this week that she was “guardedly optimistic” that the shortage crisis was abating. “I think there’s been an enormous amount of progress,” she said. “We’re seeing real change in the number of shortages that we’re able to recognize early.” More than 150 new shortages have been prevented this year, according to the agency.


But Erin Fox, who tracks supply levels for a broader range of drugs at the University of Utah, said once a drug became scarce, it tended to stay scarce. The university’s Drug Information Service was actively tracking 282 hard-to-find products by the end of the third quarter of this year, a record.


“The shortages we have aren’t going away — they’re not resolving,” she said. “But the good news is we’re not piling more shortages on top.”


In 2011, prompted by emotional pleas by cancer patients and others who said the drug shortage was threatening lives, President Obama issued an executive order requiring drug makers to notify the F.D.A. when a shortage appeared imminent. The agency also loosened some restrictions on importing drugs, and sped up approvals by other manufacturers to make certain medicines.


A law passed this summer contains several provisions aimed at improving the situation, including expediting approval of new generic medicines and requiring the agency’s enforcement unit to better coordinate with its drug-shortage officials before it takes action against a manufacturer.


Ralph G. Neas, the chief executive of the Generic Pharmaceutical Association, said fixing the drug shortage was complex and would take time, but was a top priority. “One shortage is one shortage too many,” he said. “One patient not getting a critical drug is one patient too many.”


Federal drug officials trace much of the drug shortage crisis to delays at plants that make sterile injectable drugs, which account for about 80 percent of the scarce medicines. Nearly a third of the industry’s manufacturing capacity is not running because of plant closings or shutdowns to fix serious quality issues. Other shortages have been caused by supply disruptions of the raw ingredients used to make the drugs, or by manufacturers exiting the market.


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Well: Meatless Main Dishes for a Holiday Table

Most vegetarian diners are happy to fill their plates with delicious sides and salads, but if you want to make them feel special, consider one of these main course vegetarian dishes from Martha Rose Shulman. All of them are inspired by Greek cooking, which has a rich tradition of vegetarian meals.

I know that Greek food is not exactly what comes to mind when you hear the word “Thanksgiving,” yet why not consider this cuisine if you’re searching for a meatless main dish that will please a crowd? It’s certainly a better idea, in my mind, than Tofurky and all of the other overprocessed attempts at making a vegan turkey. If you want to serve something that will be somewhat reminiscent of a turkey, make the stuffed acorn squashes in this week’s selection, and once they’re out of the oven, stick some feathers in the “rump,” as I did for the first vegetarian Thanksgiving I ever cooked: I stuffed and baked a huge crookneck squash, then decorated it with turkey feathers. The filling wasn’t nearly as good as the one you’ll get this week, but the creation was fun.

Here are five new vegetarian recipes for your Thanksgiving table — or any time.

Giant Beans With Spinach, Tomatoes and Feta: This delicious, dill-infused dish is inspired by a northern Greek recipe from Diane Kochilas’s wonderful new cookbook, “The Country Cooking of Greece.”


Northern Greek Mushroom and Onion Pie: Meaty portobello mushrooms make this a very substantial dish.


Roasted Eggplant and Chickpeas With Cinnamon-Tinged Tomato Sauce and Feta: This fragrant and comforting dish can easily be modified for vegans.


Coiled Greek Winter Squash Pie: The extra time this beautiful vegetable pie takes to assemble is worth it for a holiday dinner.


Baked Acorn Squash Stuffed With Wild Rice and Kale Risotto: Serve one squash to each person at your Thanksgiving meal: They’ll be like miniature vegetarian (or vegan) turkeys.


Read More..

Well: Meatless Main Dishes for a Holiday Table

Most vegetarian diners are happy to fill their plates with delicious sides and salads, but if you want to make them feel special, consider one of these main course vegetarian dishes from Martha Rose Shulman. All of them are inspired by Greek cooking, which has a rich tradition of vegetarian meals.

I know that Greek food is not exactly what comes to mind when you hear the word “Thanksgiving,” yet why not consider this cuisine if you’re searching for a meatless main dish that will please a crowd? It’s certainly a better idea, in my mind, than Tofurky and all of the other overprocessed attempts at making a vegan turkey. If you want to serve something that will be somewhat reminiscent of a turkey, make the stuffed acorn squashes in this week’s selection, and once they’re out of the oven, stick some feathers in the “rump,” as I did for the first vegetarian Thanksgiving I ever cooked: I stuffed and baked a huge crookneck squash, then decorated it with turkey feathers. The filling wasn’t nearly as good as the one you’ll get this week, but the creation was fun.

Here are five new vegetarian recipes for your Thanksgiving table — or any time.

Giant Beans With Spinach, Tomatoes and Feta: This delicious, dill-infused dish is inspired by a northern Greek recipe from Diane Kochilas’s wonderful new cookbook, “The Country Cooking of Greece.”


Northern Greek Mushroom and Onion Pie: Meaty portobello mushrooms make this a very substantial dish.


Roasted Eggplant and Chickpeas With Cinnamon-Tinged Tomato Sauce and Feta: This fragrant and comforting dish can easily be modified for vegans.


Coiled Greek Winter Squash Pie: The extra time this beautiful vegetable pie takes to assemble is worth it for a holiday dinner.


Baked Acorn Squash Stuffed With Wild Rice and Kale Risotto: Serve one squash to each person at your Thanksgiving meal: They’ll be like miniature vegetarian (or vegan) turkeys.


Read More..

Shortcuts: The Meaning in a Drawer Full of Old Family Snapshots


Eric Thayer/Reuters


A resident found photos as she sifted the debris of a house destroyed by Hurricane Sandy in Union Beach, N.J.







I WASN’T going to write about Hurricane Sandy. I was going to write about the changing nature of photographs and our relationship to them in this digital age.








Doug Mills/The New York Times

Picture-taking is now mainly digital, making prints of photos uncommon.






But as I began my research, I came across a Facebook page where lost photos from the storm were posted. Called “Union Beach — Photos and Misplaced Items,” the page shows photos of newborns and birthday parties, weddings and family gatherings.


Starting the morning after the storm devastated her community of Union Beach, N.J., Jeanette Van Houten and her niece have collected over a thousand photos and some photo albums. She is making it her mission to scan and post to Facebook as many as possible, including those turned into the fire department, police station and borough hall.


In addition, she was handed a drawerful of over a thousand family photos that must have been wrenched from a dresser.


About 60 photos have been claimed so far, and some professionals have offered to restore damaged photos free.


“These photos were passed down through families and they survived Sandy, even if the structures they were in didn’t,” Ms. Van Houten said. “They tell our story.”


With the Facebook page, Ms. Van Houten uses newer technology to help people reconnect with their old-fashioned snapshots. And seeing the photographs of mundane scenes and milestones on Facebook, along with the grateful comments from people who got back a bit of their lives, reminded me of both the fragility and strength of photos and their continuing importance in our lives. Judith Dupré, author of “Monuments: America’s History in Art and Memory” (Random House, 2007), and other books, teaches a class at her local library in Mamaroneck, N.Y., called “Stories from My Life,” for older residents. They use photos and stories to write about their lives.


“They bring in a basketful of photos,” Ms. Dupré said. “Each one of these photos contains a story — they’re like a key that opens the door to a life.”


And a printed photo “is a different species than a digital photo,” she said. “I don’t think anyone’s figured out the place of digital photos in terms of memory keeping.”


When an elderly aunt of hers died and left behind lots of photographs, Ms. Dupré said the family took them to the memorial service.


“We had a table and people could select and take what they wanted,” she said. “It was a very moving part of the memorial.”


Of course, even prints can lose their meaning and poignancy through the generations.


And in some cases, as with Hurricane Sandy, photos may be safer in cyberspace than in an album on a bookshelf — as long as you remember to upload them to a site like Flickr, Shutterfly, Snapfish or countless other photo sites available. (And make sure you know how long a site will keep your photos. Some, for example, require you to show some activity at least once a year.) That way, if you lose your hard drive, you don’t lose your photos.


But Ms. Dupré said she worried that photos that existed only online somewhere might die with the photographer.


“I don’t even know what my parents have in terms of digital photography,” she said. She said she put the password to her photos safely away with her will and other documents, so her children can access them.


Now I’m not trying to say that the old-fashioned way is the only way. Photography has constantly evolved. The Brownie camera, first sold by Kodak for $1 in 1900, radicalized photography by making it available to just about everyone.


But, and I know this largely a generational thing, I can’t help but wonder about the ubiquity of the cellphone photo. As Ms. Dupré said, “The infinite number of digital photos that can be taken has devalued the single image and made one-of-a-kind prints that much more precious.”


E-mail: shortcuts@nytimes.com



Read More..

Israel Sticks to Tough Approach in Conflict With Hamas





TEL AVIV — With rockets landing on the outskirts of Tel Aviv and Jerusalem on Friday and the Egyptian prime minister making a solidarity visit to Gaza, the accelerating conflict between Israel and Hamas — reminiscent in many ways of so many previous battles — has the makings of a new kind of Israeli-Palestinian face-off.




The combination of longer-range and far deadlier rockets in the hands of more radicalized Palestinians, the arrival in Gaza and Sinai from North Africa of other militants pressuring Hamas to fight more, and the growing tide of anti-Israel fury in a region where authoritarian rulers have been replaced by Islamists means that Israel is engaging in this conflict with a different set of challenges.


The Middle East of 2012 is not what it was in late 2008, the last time Israel mounted a military invasion to reduce the rocket threat from Gaza. Many analysts and diplomats outside Israel say the country today needs a different approach to Hamas and the Palestinians based more on acknowledging historic grievances and shifting alliances.


“As long as the crime of dispossession and refugeehood that was committed against the Palestinian people in 1947-48 is not redressed through a peaceful and just negotiation that satisfies the legitimate rights of both sides, we will continue to see enhancements in both the determination and the capabilities of Palestinian fighters — as has been the case since the 1930s, in fact,” Rami G. Khouri, a professor at the American University of Beirut, wrote in an online column. “Only stupid or ideologically maniacal Zionists fail to come to terms with this fact.”


But the government in Israel and the vast majority of its people have drawn a very different conclusion. Their dangerous neighborhood is growing still more dangerous, they agree. That means not concessions, but being tougher in pursuit of deterrence, and abandoning illusions that a Jewish state will ever be broadly accepted here.


“There is a theory, which I believe, that Hamas doesn’t want a peaceful solution and only wants to keep the conflict going forever until somehow in their dream they will have all of Israel,” Eitan Ben Eliyahu, a former leader of the Israeli Air Force, said in a telephone briefing. “There is a good chance we will go into Gaza on the ground again.”


What is striking in listening to the Israelis discuss their predicament is how similar the debate sounds to so many previous ones, despite the changed geopolitical circumstances. In most minds here, the changes do not demand a new strategy, simply a redoubled old one.


The operative metaphor is often described as “cutting the grass,” meaning a task that must be performed regularly and has no end. There is no solution to security challenges, officials here say, only delays and deterrence. That is why the idea of one day attacking Iranian nuclear facilities, even though such an attack would set the nuclear program back only two years, is widely discussed as a reasonable option. That is why frequent raids in the West Bank and surveillance flights over Lebanon never stop.


And that is why this week’s operation in Gaza is widely viewed as having been inevitable, another painful but necessary maintenance operation that, officials here say, will doubtless not be the last.


There are also those who believe that the regional upheavals are improving Israel’s ability to carry out deterrence. One retired general who remains close to the military and who spoke on the condition of anonymity said that with Syria torn apart by civil war, Hezbollah in Lebanon discredited because of its support for the Syrian government, and Egypt so weakened economically, Israel should not worry about anything but protecting its civilians.


“Should we let our civilians be bombed because the Arab world is in trouble?” he asked.


So much was happening elsewhere in the region — the Egyptian and Libyan revolutions, the Syrian civil war, dramatic changes in Yemen and elections in Tunisia — that a few rockets a day that sent tens of thousands of Israeli civilians into bomb shelters drew little attention. But in the Israeli view, the necessity of a Gaza operation has been growing steadily throughout the Arab Spring turmoil.


In 2009, after the Israeli invasion pushed Hamas back and killed about 1,400 people in Gaza, 200 rockets hit Israel. The same was true in 2010. But last year the number rose to 600, and before this week the number this year was 700, according to the Israeli military. The problem went beyond rockets to mines planted near the border aimed at Israeli military jeeps and the digging of explosive-filled tunnels.


“In 2008 we managed to minimize rocket fire from Gaza significantly,” said Lt. Col. Avital Leibovich, a military spokeswoman. “We started that year with 100 rockets a week and ended it with two a week. We were able to give people in our south two to three years. But the grass has grown, and other things have as well. Different jihadist ideologies have found their way into Gaza, including quite a few terrorist organizations. More weapons have come in, including the Fajr-5, which is Iranian made and can hit Tel Aviv. That puts nearly our entire population in range. So we reached a point where we cannot act with restraint any longer.”


Gazans see events in a very different light. The problem, they say, comes from Israel: Israeli drones fill the Gazan skies, Israeli gunboats strafe their waters, Palestinian militants are shot at from the air, and the Gaza border areas are declared off limits by Israel with the risk of death from Israeli gunfire.


But there is little dissent in Israel about the Gaza policy. This week leaders of the leftist opposition praised the assassination of Ahmed al-Jabari, the Hamas military commander, on Wednesday. He is viewed here as the equivalent of Osama bin Laden. The operation could go on for many days before there is any real dissent.


The question here, nonetheless, is whether the changed regional circumstances will make it harder to “cut the grass” in Gaza this time and get out. A former top official who was actively involved in the last Gaza war and who spoke on the condition of anonymity said it looked to him as if Hamas would not back down as easily this time.


“They will not stop until enough Israelis are killed or injured to create a sense of equality or balance,” he said. “If a rocket falls in the middle of Tel Aviv, that will be a major success. But this government will go back at them hard. I don’t see this ending in the next day or two.”


Read More..

Automated Bidding Systems Test Old Ways of Selling Ads





Publishers and broadcasters have long tried to offer advertisers the right audience for their products. Want to sell pick-ups to people who like sports? Buy ads at halftime during a football game. Selling luggage or airline tickets? Buy ads in the travel section of a newspaper or Web site.




In digital advertising, that formula is being increasingly tested by fast-paced, algorithmic bidding systems that target individual consumers rather than the aggregate audience publishers serve up. In the world of “programmatic buying” technologies, context matters less than tracking those consumers wherever they go. And that kind of buying is the reason that shoe ad follows you whether you’re on Weather.com or on a local news blog.


That shift is punishing traditional online publishers, like newspaper, broadcast and magazine sites, who are receiving a much lower percentage of ad dollars as marketers use programmatic buying across a much broader canvas. Some sites, like CNN.com, refuse to even accept advertising through programmatic buying because they do not want to cede control over what ads will appear.


“It’s allowing advertisers to assign value to media rather than publishers,” said Ben Winkler, the chief digital officer at OMD, an agency in the Omnicom Media Group. Publishers, he said, “can’t control the price, but they can control the quality of the content and the audience on that site.”


About 10 percent of the display ads that consumers see online have been sold through programmatic bidding channels, according to Walter Knapp, the executive vice president of platform revenue and operations at Federated Media, one of the world’s largest digital advertising networks.


Advertisers like Nike, Comcast, Progressive and Procter & Gamble are now using the programmatic buying, and luxury advertisers are starting to follow. According to data from Forrester Research, all ads traded on exchanges, as programmatic ads are, increased more than 17.5 percent to about 629 billion impressions (the number of times an ad appears) in 2012, from 535 billion in 2011.


That growth is affecting publishers of all stripes, but few are willing to discuss their internal numbers. “For a publisher to admit they’ve been hurt is tough for the big guys,” said John Ebbert, the executive editor and publisher of the Web site AdExchanger.


When The New York Times Company announced its earnings last month, the company posted a profit, but said that digital advertising fell 2.2 percent. Jim Follo, the company’s senior vice president and chief financial officer, attributed the dip, in part, on a “shift toward ad exchanges, real-time bidding and other programmatic buying channels that allow advertisers to buy audience at scale.”


Programmatic buying began as a way for advertisers to place lower-cost ads for products like teeth-whitening products and belly fat pills that filled up the back pages of Web sites. But the practice has gained in sophistication and breadth, with major advertisers and many of the world’s largest ad agencies creating private exchanges to automate the buying and selling of ads.


Programmatic buying includes a number of different technologies and strategies, but it essentially allows advertisers to bid, often in real time, on ad space largely based on the value they have assigned to the consumer on the other side of the screen. Say, for example, that Nike wants to sell running gear to a particular consumer who has a high likelihood of buying shoes based on the data it has collected, including the type of Web sites that consumer typically visits. Because the ad-buying is done through computer trading, the price for that space can change rapidly.


“Accessing media is a commodity now,” said Sheldon Gilbert, the founder and chief executive of Proclivity Media, a company that specializes in digital advertising technologies. “Instead of having to commit four months in advance, you can now bid and buy an individual impression in real time.”


In the short run, the growth in programmatic buying has forced overall ad prices to fall. A media buyer who would have once spent $50,000 worth of advertising on a publisher’s site, at, say, an $8 cost-per-thousand, can now buy ad impressions on any Web site on which they happen to find their intended audience and pay less per ad, Mr. Ebbert said.


“There is no scarcity of premium online,” said Dan Salmon, an equity research analyst at BMO Capital Markets. “There’s only one Super Bowl, but there are lots of different places to buy banner ads online.”


While the “halo effect” of buying an ad against premium content has not disappeared entirely — many advertisers still want front-page placement on popular Web sites — the shift is prompting publishers to rethink how they sell their ads.


Clark Fredricksen, the vice president for communications at eMarketer, a data company, said that publishers were “going to have to double down to prove the value of their inventory as they compete with other, cheaper inventory.”


And some publishers are jumping into the game themselves. During the most recent AOL earnings call, Tim Armstrong, the company’s chairman and chief executive, said it was bullish on programmatic buying, despite being a publisher itself with properties that include TechCrunch and The Huffington Post. The company trades its ads through its own ad network, Ad.com, and others like it.


“We will continue to invest in people and technology to capture the programmatic business of advertising,” Mr. Armstrong said.


Like AOL, Weather.com is also aggressively moving into programmatic bidding. “Instead of thinking of us a publisher, think of us as a marketing engine,” said Curt Hecht, the chief global revenue officer for the Weather Company.


Neal Mohan, the vice president for product management at Google, which sells advertising though its DoubleClick network, says that in the long run, publishers could see higher returns from programmatic advertising. In the last year, the number of advertisers and publishers using the DoubleClick platform has doubled, Mr. Mohan said, while the rates for those using the platform have increased 11 percent. But that means publishers will have to play by different rules.


“Context still matters and so does placement,” Mr. Ebbert said. “But it’s only one element.”


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For Alzheimer’s, Detection Advances Outpace Treatment Options


Joshua Lott for The New York Times


Awilda Jimenez got a scan for Alzheimer’s after she started forgetting things. It was positive.







When Awilda Jimenez started forgetting things last year, her husband, Edwin, felt a shiver of dread. Her mother had developed Alzheimer’s in her 50s. Could his wife, 61, have it, too?




He learned there was a new brain scan to diagnose the disease and nervously agreed to get her one, secretly hoping it would lay his fears to rest. In June, his wife became what her doctor says is the first private patient in Arizona to have the test.


“The scan was floridly positive,” said her doctor, Adam S. Fleisher, director of brain imaging at the Banner Alzheimer’s Institute in Phoenix.


The Jimenezes have struggled ever since to deal with this devastating news. They are confronting a problem of the new era of Alzheimer’s research: The ability to detect the disease has leapt far ahead of treatments. There are none that can stop or even significantly slow the inexorable progression to dementia and death.


Families like the Jimenezes, with no good options, can only ask: Should they live their lives differently, get their affairs in order, join a clinical trial of an experimental drug?


“I was hoping the scan would be negative,” Mr. Jimenez said. “When I found out it was positive, my heart sank.”


The new brain scan technology, which went on the market in June, is spreading fast. There are already more than 300 hospitals and imaging centers, located in most major metropolitan areas, that are ready to perform the scans, according to Eli Lilly, which sells the tracer used to mark plaque for the scan.


The scans show plaques in the brain — barnaclelike clumps of protein, beta amyloid — that, together with dementia, are the defining feature of Alzheimer’s disease. Those who have dementia but do not have excessive plaques do not have Alzheimer’s. It is no longer necessary to wait until the person dies and has an autopsy to learn if the brain was studded with plaques.


Many insurers, including Medicare, will not yet pay for the new scans, which cost several thousand dollars. And getting one comes with serious risks. While federal law prevents insurers and employers from discriminating based on genetic tests, it does not apply to scans. People with brain plaques can be denied long-term care insurance.


The Food and Drug Administration, worried about interpretations of the scans, has required something new: Doctors must take a test showing they can read them accurately before they begin doing them. So far, 700 doctors have qualified, according to Eli Lilly. Other kinds of diagnostic scans have no such requirement.


In another unusual feature, the F.D.A. requires that radiologists not be told anything about the patient. They are generally trained to incorporate clinical information into their interpretation of other types of scans, said Dr. R. Dwaine Rieves, director of the drug agency’s Division of Medical Imaging Products.


But in this case, clinical information may lead radiologists to inadvertently shade their reports to coincide with what doctors suspect is the underlying disease. With Alzheimer’s, Dr. Rieves said, “clinical impressions have been misleading.”


“This is a big change in the world of image interpretation,” he said.


Like some other Alzheimer’s experts, Dr. Fleisher used the amyloid scan for several years as part of a research study that led to its F.D.A. approval. Subjects were not told what the scans showed. Now, with the scan on the market, the rules have changed.


Dr. Fleisher’s first patient was Mrs. Jimenez. Her husband, the family breadwinner, had lost his job as a computer consultant when the couple moved from New York to Arizona to take care of Mrs. Jimenez’s mother. Paying several thousand dollars for a scan was out of the question. But Dr. Fleisher found a radiologist, Dr. Mantej Singh Sra of Sun Radiology, who was so eager to get into the business that he agreed to do Mrs. Jimenez’s scan free. His plan was to be the first in Arizona to do a scan, and advertise it.


After Dr. Sra did the scan, the Jimenezes returned to Dr. Fleisher to learn the result.


Dr. Fleisher, sad to see so much plaque in Mrs. Jimenez’s brain, referred her to a psychiatrist to help with anxiety and suggested she enter clinical trials of experimental drugs.


But Mr. Jimenez did not like that idea. He worried about unexpected side effects.


“Tempting as it is, where do you draw the line?” he asks. “At what point do you take a risk with a loved one?”


At Mount Sinai Medical Center in New York, Dr. Samuel E. Gandy found that his patients — mostly affluent — were unfazed by the medical center’s $3,750 price for the scan. He has been ordering at least one a week for people with symptoms ambiguous enough to suggest the possibility of brain plaques.


Most of his patients want their names kept confidential, fearing an inability to get long-term care insurance, or just wanting privacy.


Read More..

For Alzheimer’s, Detection Advances Outpace Treatment Options


Joshua Lott for The New York Times


Awilda Jimenez got a scan for Alzheimer’s after she started forgetting things. It was positive.







When Awilda Jimenez started forgetting things last year, her husband, Edwin, felt a shiver of dread. Her mother had developed Alzheimer’s in her 50s. Could his wife, 61, have it, too?




He learned there was a new brain scan to diagnose the disease and nervously agreed to get her one, secretly hoping it would lay his fears to rest. In June, his wife became what her doctor says is the first private patient in Arizona to have the test.


“The scan was floridly positive,” said her doctor, Adam S. Fleisher, director of brain imaging at the Banner Alzheimer’s Institute in Phoenix.


The Jimenezes have struggled ever since to deal with this devastating news. They are confronting a problem of the new era of Alzheimer’s research: The ability to detect the disease has leapt far ahead of treatments. There are none that can stop or even significantly slow the inexorable progression to dementia and death.


Families like the Jimenezes, with no good options, can only ask: Should they live their lives differently, get their affairs in order, join a clinical trial of an experimental drug?


“I was hoping the scan would be negative,” Mr. Jimenez said. “When I found out it was positive, my heart sank.”


The new brain scan technology, which went on the market in June, is spreading fast. There are already more than 300 hospitals and imaging centers, located in most major metropolitan areas, that are ready to perform the scans, according to Eli Lilly, which sells the tracer used to mark plaque for the scan.


The scans show plaques in the brain — barnaclelike clumps of protein, beta amyloid — that, together with dementia, are the defining feature of Alzheimer’s disease. Those who have dementia but do not have excessive plaques do not have Alzheimer’s. It is no longer necessary to wait until the person dies and has an autopsy to learn if the brain was studded with plaques.


Many insurers, including Medicare, will not yet pay for the new scans, which cost several thousand dollars. And getting one comes with serious risks. While federal law prevents insurers and employers from discriminating based on genetic tests, it does not apply to scans. People with brain plaques can be denied long-term care insurance.


The Food and Drug Administration, worried about interpretations of the scans, has required something new: Doctors must take a test showing they can read them accurately before they begin doing them. So far, 700 doctors have qualified, according to Eli Lilly. Other kinds of diagnostic scans have no such requirement.


In another unusual feature, the F.D.A. requires that radiologists not be told anything about the patient. They are generally trained to incorporate clinical information into their interpretation of other types of scans, said Dr. R. Dwaine Rieves, director of the drug agency’s Division of Medical Imaging Products.


But in this case, clinical information may lead radiologists to inadvertently shade their reports to coincide with what doctors suspect is the underlying disease. With Alzheimer’s, Dr. Rieves said, “clinical impressions have been misleading.”


“This is a big change in the world of image interpretation,” he said.


Like some other Alzheimer’s experts, Dr. Fleisher used the amyloid scan for several years as part of a research study that led to its F.D.A. approval. Subjects were not told what the scans showed. Now, with the scan on the market, the rules have changed.


Dr. Fleisher’s first patient was Mrs. Jimenez. Her husband, the family breadwinner, had lost his job as a computer consultant when the couple moved from New York to Arizona to take care of Mrs. Jimenez’s mother. Paying several thousand dollars for a scan was out of the question. But Dr. Fleisher found a radiologist, Dr. Mantej Singh Sra of Sun Radiology, who was so eager to get into the business that he agreed to do Mrs. Jimenez’s scan free. His plan was to be the first in Arizona to do a scan, and advertise it.


After Dr. Sra did the scan, the Jimenezes returned to Dr. Fleisher to learn the result.


Dr. Fleisher, sad to see so much plaque in Mrs. Jimenez’s brain, referred her to a psychiatrist to help with anxiety and suggested she enter clinical trials of experimental drugs.


But Mr. Jimenez did not like that idea. He worried about unexpected side effects.


“Tempting as it is, where do you draw the line?” he asks. “At what point do you take a risk with a loved one?”


At Mount Sinai Medical Center in New York, Dr. Samuel E. Gandy found that his patients — mostly affluent — were unfazed by the medical center’s $3,750 price for the scan. He has been ordering at least one a week for people with symptoms ambiguous enough to suggest the possibility of brain plaques.


Most of his patients want their names kept confidential, fearing an inability to get long-term care insurance, or just wanting privacy.


Read More..

Gadgetwise Blog: Q&A: Removing Programs on a Mac

Windows computers have the Add/Remove Program option and many programs include uninstaller software, but how do you uninstall a Mac program?

Some Mac programs do come with their own uninstaller programs to remove the software from the computer. If the program you want to delete does not offer that utility, you can get rid of it in other ways.

Just dragging the program’s icon out of the Applications folder to the Mac’s desktop Trash can — and then going to the Finder’s File menu and choosing Empty Trash — gets rid of the program and many of its associated files. Some Mac application icons contain many more files than just the program itself; just right-click on an icon in the Applications folder and choose Show Package Contents from the menu to see what lies beneath.

Some programs leave other files around the Mac’s system, though, and just deleting the application’s icon from the computer may leave some digital detritus on your drive. If you are comfortable with poking around in OS X, tutorials like those from Cult of Mac or Raw Computing show where to look in your clean-up mission. For a more automatic approach, free or inexpensive utility apps like AppDelete, AppZapper and CleanApp can take care of the job for you.

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BP to Admit Crimes and Pay $4.5 Billion in Gulf Settlement








LONDON — BP, the British oil company, said Thursday it would pay $4.5 billion in fines and other payments to the United States government and plead guilty to 14 criminal charges in connection with the giant oil spill in the Gulf of Mexico two years ago.







US Coast Guard, via Associated Press

The explosion on the Deepwater Horizon drilling rig in the Gulf of Mexico that was connected to a well owned by BP killed 11 workers and spilled millions of barrels of oil.









The payments include a $4 billion fine to be paid over five years, with much of it to go to government environmental agencies, BP said in a statement.


As part of the settlement, BP pleaded guilty to 11 felony misconduct or neglect charges related to the deaths of 11 people in the Deepwater Horizon accident in 2010, which unleashed millions of barrels of oil into the gulf.


A law enforcement official familiar with the case also said that two BP employees would be charged with manslaughter in the case. The United States attorney general, Eric H. Holder Jr., was scheduled to hold a news conference in New Orleans later Thursday.


“Today’s agreement is consistent with BP’s position in the ongoing civil litigation that this was an accident resulting from multiple causes, involving multiple parties, as found by other official investigations,” the company said in a news release.


The company said earlier Thursday it was in advanced talks with the United States about settling all criminal claims stemming from the spill.


Even with a settlement on the criminal claims, BP would still be subject to other claims, including federal civil claims and claims for damages to natural resources.


In particular, this settlement does not include what is potentially the largest penalty: fines under the Clean Water Act. The potential fine for the spill under the Clean Water Act is $1,100 to $4,300 per barrel spilled. That means the fine could be as much as $21 billion, according to Peter Hutton of RBC Capital Markets in London.


BP repeatedly said it would like to reach a settlement with claimants if the terms were reasonable. The unresolved issue of the claims has been weighing on BP’s share price as the oil company has been under pressure from investors to move on from the disastrous oil spill that had hurt the company’s reputation and finances.


An explosion in 2010 on the Deepwater Horizon drilling rig in the Gulf of Mexico that was connected to a well owned by BP killed 11 oil workers and spilled millions of barrels of oil into the surrounding water.


BP in March agreed with the lawyers for plaintiffs to settle claims on economic loss, including from the local seafood industry, and medical claims stemming from the oil spill. BP said at the time it expected the cost of that settlement to be about $7.8 billion, which it will pay from a trust the company set aside to cover such costs.


The company returned to profitability in the third quarter and increased its dividend, it said in October. It has been shrinking as it sold assets to raise funds to pay for costs related to the oil spill.


Stanley Reed contributed reporting from London. Charlie Savage contributed from Washington.


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Beta Blockers May Calm Nerves, Keeping Them Banned by PGA and L.P.G.A.





Greg Norman, winner of 91 tournaments worldwide, remembers a time when panic attacks on the elite golf circuit were often alleviated with the illicit use of a common heart and blood pressure medicine, the beta blocker.




“In my day, lots of guys were on beta blockers,” Norman, 57, said in an interview at the P.G.A. Championship in August. “It wasn’t openly acknowledged, but it was obvious to the rest of us. A guy’s personality would change. In practice rounds or friendly matches, we’d see the real guy under stress. Then in competition, he was like a different, calmer person. Those guys were trying to take the nerves out of the game. But nerves are very much a part of the game.”


Norman was far from the only one with the tacit understanding that beta blockers, also prescribed for stage fright, were part of big-time golf. So in 2008, when the PGA and L.P.G.A. Tours were establishing their antidoping programs, beta blockers were included on the banned substance lists.


The little pill that inadvertently, or not so inadvertently, soothes the jitters and helps settle the bets in a recreational weekend match — nearly one in three Americans have high blood pressure, so it might be resolving a lot of $5 wagers — is strictly policed when the PGA Tour paydays top $1 million.


The permissibility of beta blockers in golf’s top level has come into focus anew this week. Charlie Beljan won a PGA Tour event Sunday, two days after being hospitalized with a panic attack. Beljan, who said that this week he was going to consult doctors near his home in Arizona, might be treated with medication to prevent future panic attacks. But in competition, he will not be allowed to take certain medications, like beta blockers, without applying for a therapeutic use exemption, which requires a review by an independent panel of doctors.


Dr. Nicole Danforth, a psychiatrist, the medical director of Massachusetts General Hospital’s sports psychology program and a former professional golfer, said, “I think beta blockers could treat the yips, and I think the tours think so, too, or they wouldn’t ban them.”


Beta blockers are prohibited in many sports other than golf, including Olympic sports. The PGA Tour took its lead from the United States Anti-Doping Agency and the World Anti-Doping Agency in adding beta blockers to its list.


“One of the many pharmacological uses of beta blockers is the steadying of hand tremors,” said Andy Levinson, the executive director of the PGA Tour’s antidoping program. “Anything requiring fine motor skills could be affected, something necessary in sports like archery or golf.”


At the 2008 Beijing Olympics, Kim Jong-su of North Korea had to return the silver medal he won in the 50-meter pistol event and the bronze he won in the 10-meter air pistol event after testing positive for propranolol, a beta blocker.


For millions of Americans who take beta blockers, enhancing athletic performance is far from the purpose. Beta blockers are heart medicines meant to control blood pressure, slow the heartbeat and treat a variety of other heart conditions. That they might help calm nerves in a pressure situation is almost an accidental side effect.


“It so happens that the response to an anxiety-producing situation is also driven by the sympathetic nervous system that the beta blocker is trying to control for the good of the patient’s heart,” said Dr. Binoy K. Singh, the associate chief of cardiology at Lenox Hill Hospital in New York.


But Singh said he knew of no long-term, randomized clinical trials measuring beta blockers’ effectiveness in resolving anxiety or improving performance in pressure situations, even if he has had patients tell him they have noticed a calmness in those settings.


There is, in fact, no universal agreement on whether beta blockers help or hurt in some athletic situations.


“Some level of anxiety is good for performance,” said Richard Ginsburg, a sports psychologist at the Harvard Medical School and Massachusetts General Hospital. “It keeps you on your game. A beta blocker can take away some edge, mellow you too much.”


Danforth, who twice played in the United States Women’s Open, agreed, though she added that beta blockers, purely from a golf perspective, had been likened to the stabilizing advantage some find using a long putter.


There are medical concerns for those who acquire beta blockers without a prescription, perhaps through the plethora of Web sites selling the drugs. Singh said there was a serious risk for people using beta blockers without a genuine, long-term medical need for them.


“They are a very powerful class of drugs that have enormous impact on essential bodily functions,” he said. “They are not without adverse effects.”


Beta blockers are far from the primary treatment for panic attacks. There are a variety of medications, doctors said, and there are multiple treatments that do not involve drugs. Among the most effective treatments has been cognitive behavioral therapy. Some anti-anxiety drugs, like Xanax or Valium, are not on most prohibited substance lists, including the one used by the PGA Tour.


But if a golfer on the PGA or L.P.G.A. Tours can prove a documented medical condition that requires the use of a prohibited substance, an exemption is granted. Levinson said a beta blocker exemption had been granted.


When it comes to the recreational golfing community, no doctors said they had a patient who requested a beta blocker prescription to help with the frustrations and strain of playing golf. Singh, who said he was a golfer who had played in stressful weekend matches, was asked if he had ever been tempted to take a beta blocker for the benefits it might bring to his scorecard.


“No, but I would have benefited from a better golf game,” he said.


Read More..

Beta Blockers May Calm Nerves, Keeping Them Banned by PGA and L.P.G.A.





Greg Norman, winner of 91 tournaments worldwide, remembers a time when panic attacks on the elite golf circuit were often alleviated with the illicit use of a common heart and blood pressure medicine, the beta blocker.




“In my day, lots of guys were on beta blockers,” Norman, 57, said in an interview at the P.G.A. Championship in August. “It wasn’t openly acknowledged, but it was obvious to the rest of us. A guy’s personality would change. In practice rounds or friendly matches, we’d see the real guy under stress. Then in competition, he was like a different, calmer person. Those guys were trying to take the nerves out of the game. But nerves are very much a part of the game.”


Norman was far from the only one with the tacit understanding that beta blockers, also prescribed for stage fright, were part of big-time golf. So in 2008, when the PGA and L.P.G.A. Tours were establishing their antidoping programs, beta blockers were included on the banned substance lists.


The little pill that inadvertently, or not so inadvertently, soothes the jitters and helps settle the bets in a recreational weekend match — nearly one in three Americans have high blood pressure, so it might be resolving a lot of $5 wagers — is strictly policed when the PGA Tour paydays top $1 million.


The permissibility of beta blockers in golf’s top level has come into focus anew this week. Charlie Beljan won a PGA Tour event Sunday, two days after being hospitalized with a panic attack. Beljan, who said that this week he was going to consult doctors near his home in Arizona, might be treated with medication to prevent future panic attacks. But in competition, he will not be allowed to take certain medications, like beta blockers, without applying for a therapeutic use exemption, which requires a review by an independent panel of doctors.


Dr. Nicole Danforth, a psychiatrist, the medical director of Massachusetts General Hospital’s sports psychology program and a former professional golfer, said, “I think beta blockers could treat the yips, and I think the tours think so, too, or they wouldn’t ban them.”


Beta blockers are prohibited in many sports other than golf, including Olympic sports. The PGA Tour took its lead from the United States Anti-Doping Agency and the World Anti-Doping Agency in adding beta blockers to its list.


“One of the many pharmacological uses of beta blockers is the steadying of hand tremors,” said Andy Levinson, the executive director of the PGA Tour’s antidoping program. “Anything requiring fine motor skills could be affected, something necessary in sports like archery or golf.”


At the 2008 Beijing Olympics, Kim Jong-su of North Korea had to return the silver medal he won in the 50-meter pistol event and the bronze he won in the 10-meter air pistol event after testing positive for propranolol, a beta blocker.


For millions of Americans who take beta blockers, enhancing athletic performance is far from the purpose. Beta blockers are heart medicines meant to control blood pressure, slow the heartbeat and treat a variety of other heart conditions. That they might help calm nerves in a pressure situation is almost an accidental side effect.


“It so happens that the response to an anxiety-producing situation is also driven by the sympathetic nervous system that the beta blocker is trying to control for the good of the patient’s heart,” said Dr. Binoy K. Singh, the associate chief of cardiology at Lenox Hill Hospital in New York.


But Singh said he knew of no long-term, randomized clinical trials measuring beta blockers’ effectiveness in resolving anxiety or improving performance in pressure situations, even if he has had patients tell him they have noticed a calmness in those settings.


There is, in fact, no universal agreement on whether beta blockers help or hurt in some athletic situations.


“Some level of anxiety is good for performance,” said Richard Ginsburg, a sports psychologist at the Harvard Medical School and Massachusetts General Hospital. “It keeps you on your game. A beta blocker can take away some edge, mellow you too much.”


Danforth, who twice played in the United States Women’s Open, agreed, though she added that beta blockers, purely from a golf perspective, had been likened to the stabilizing advantage some find using a long putter.


There are medical concerns for those who acquire beta blockers without a prescription, perhaps through the plethora of Web sites selling the drugs. Singh said there was a serious risk for people using beta blockers without a genuine, long-term medical need for them.


“They are a very powerful class of drugs that have enormous impact on essential bodily functions,” he said. “They are not without adverse effects.”


Beta blockers are far from the primary treatment for panic attacks. There are a variety of medications, doctors said, and there are multiple treatments that do not involve drugs. Among the most effective treatments has been cognitive behavioral therapy. Some anti-anxiety drugs, like Xanax or Valium, are not on most prohibited substance lists, including the one used by the PGA Tour.


But if a golfer on the PGA or L.P.G.A. Tours can prove a documented medical condition that requires the use of a prohibited substance, an exemption is granted. Levinson said a beta blocker exemption had been granted.


When it comes to the recreational golfing community, no doctors said they had a patient who requested a beta blocker prescription to help with the frustrations and strain of playing golf. Singh, who said he was a golfer who had played in stressful weekend matches, was asked if he had ever been tempted to take a beta blocker for the benefits it might bring to his scorecard.


“No, but I would have benefited from a better golf game,” he said.


Read More..

State of the Art: A Review of New Activity-Tracking Bands From Nike and Jawbone





Maybe you’ve heard: Americans are becoming less fit and more fat. There are all kinds of theories about why — bigger meal portions, omnipresent corn syrup and sugar, fewer pickup stickball games after school. But people are starting to think that in many cases, body weight might somehow be linked to diet and exercise.




Now, studies have shown that if there’s some visible, omnipresent monitor of your negative behavior — spending too much money, eating too much food, using too much power in your home — you’re far more likely to correct it.


That’s the idea behind personal activity-tracking bracelets like the Nike FuelBand ($150) and the improved Jawbone Up band ($130). They make you constantly aware of how active you are (or aren’t). They let you compare your data with friends online, establishing a friendly rivalry or at least guilt. And they therefore motivate you to make changes that add up: park farther away, take the stairs, get off one bus stop early.


There are plenty of other fitness trackers, including clip-onto-clothing trackers (like the FitBit and Striiv) and wristwatchlike gadgets (like Motorola’s MotoActiv). But the beauty of the bracelets is that you can leave them on — asleep, in the shower, shirtless or even all three — and so you’re more likely to stick with the program.


Now, those who follow the wearable, accelerometer-based fitness-tracking gadget industry are no doubt scratching their heads right about now. The Up band? Wasn’t that a bracelet that came out about a year ago, and crashed and burned in a humiliatingly public epidemic of hardware failures? Didn’t Jawbone, a company known for Bluetooth speakers and earpieces, pull Up off the market, offering a generous mea culpa (“You can receive a full refund for UP. This is true even if you decide to keep your UP band”)?


Yes.


The company says that after months of testing and millions of dollars in research, it realized that the original band, billed as waterproof, actually wasn’t quite. Water, sweat and shower soap managed to seep inside and short out the components.


The new Up band, the company swears, is bulletproof. Or at least really, truly waterproof. The company says it redesigned 17 parts and made 28 improvements in the manufacturing process. The new band looks identical — it’s still a stiff, rubber, overgrown C in a choice of colors, with ends that overshoot each other — but inside, it’s far better shielded and enclosed. (It’s also $30 more expensive.)


The corresponding iPhone app has had some work done, too. The central conceit is a Facebook-style timeline of your life. Each “post” represents a day’s worth of activity, or a night of sleep, or a meal. (You can enter nonstep-based workouts manually, like biking or weights.) Your friends’ health developments can show up in your stream, too.


That doesn’t mean that the app is ready for its close-up. It’s fairly baffling, housing as it does duplicate hidden menus, and it has its share of bugs and quirks. Why, on a screen that’s much taller than it is wide, are your progress graphs inch-tall bars swimming in empty space? And wow — if you did a situp every time you got the “Sorry, there was an error connecting with the UP server” message, you’d have abs of concrete. (An Android app is in the works.)


What’s great, though, is that the Up’s ambitions extend beyond simple activity tracking. If you do a double press on the button at the end of the band when you go to bed, for example, the bracelet does an impressive job of tracking your night of sleep: how long it takes you to drift off, how many times you wake up, how many hours you spend in light and deep sleep.


A related, extremely useful feature: when you need a power nap (a 25-minute quick sleep, whose refreshing qualities have been well documented in studies), the band doesn’t start counting until it sees that you’re actually asleep. So you actually get 25 minutes, after which the band vibrates to rouse you. That’s something the average pedometer doesn’t do.


You can track your food intake in any of three ways: by taking a photo of what you eat, by scanning the bar code on its package (the app instantly and correctly identifies it) or by choosing from a categorized list of common foodstuffs. It’s still fairly manual — no wristband can tell what you’re shoving into your mouth — so most people probably won’t bother.


E-mail: pogue@nytimes.com



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Attacks Resume After Israeli Assault Kills Hamas Leader





KIRYAT MALACHI, Israel — Israel and Hamas widened their increasingly deadly conflict over Gaza on Thursday, as a militant rocket killed three civilians in an apartment block in this small southern town. The deaths were likely to lead Israel to intensify its military offensive on Gaza, now in its second day of airstrikes.




In Gaza, the Palestinian death toll rose to 11 as Israel struck what the military described as medium- and long-range rocket and infrastructure sites and rocket-launching squads. The military said it had dispersed leaflets over Gaza warning residents to stay away from Hamas operatives and facilities, suggesting that more was to come.


The regional perils of the situation sharpened, meanwhile, as President Mohamed Morsi of Egypt warned on Thursday that his country stood by the Palestinians against what he termed Israeli aggression, echoing similar condemnation on Wednesday.


“The Egyptian people, the Egyptian leadership, the Egyptian government, and all of Egypt is standing with all its resources to stop this assault, to prevent the killing and the bloodshed of Palestinians,” Mr. Morsi said in nationally televised remarks before a crisis meeting of senior ministers. He also instructed his prime minister to lead a delegation to Gaza on Friday and said he had contacted President Obama to discuss strategies to “stop these acts and doings and the bloodshed and aggression.”


In language that reflected the upheaval in the political dynamics of the Middle East since the overthrow of Hosni Mubarak last year, Mr. Morsi said: “Israelis must realize that we don’t accept this aggression and it could only lead to instability in the region and has a major negative impact on stability and security in the region.”


The thrust of Mr. Morsi’s words seemed confined to diplomatic maneuvers, including calls to the United Nations secretary general, Ban Ki-moon, the head of the Arab League and President Obama.


The 120-nation Nonalignmed Movement, the biggest bloc at the United Nations, added its condemnation of the Gaza airstrikes in a statement released by Iran, the group’s rotating president and one of Israel’s most ardent foes. “Israel, the occupying power, is, once more, escalating its military campaign against the Palestinian people, particularly in the Gaza Strip,” the group’s coordinating bureau said in the statement. The group made no mention of the Palestinian rocket fire but condemned what it called “this act of aggression by the Israelis and their resort to force against the defenseless people” and demanded “decisive action by the U.N. Security Council.”


In his conversation with Mr. Obama, Mr. Morsi said, he “clarified Egypt’s role and Egypt’s position; our care for the relations with the United States of America and the world; and at the same time our complete rejection of this assault and our rejection of these actions, of the bloodshed, and of the siege on Palestinians and their suffering.”


Mr. Obama had agreed to speak with Israeli leaders, Mr. Morsi said.


The Thursday’ deaths in Kiryat Malachi were the first casualties on the Israeli side since Israel launched its assault on Gaza, the most ferocious in four years, in response to persistent Palestinian rocket fire.


Southern Israel has been struck by more than 750 rockets fired from Gaza this year that have hit homes and caused injuries. On Thursday, a rocket smashed into the top floor of an apartment building in Kiryat Malachi, about 15 miles north of Gaza. Two men and one woman were killed, according to witnesses at the scene. A baby was among the injured and several Israelis were hospitalized with shrapnel wounds after rockets hit other southern cities and towns, they said.The apartment house was close to a field in a blue-collar neighborhood and the rocket tore open top-floor apartments, leaving twisted metal window frames and bloodstains.


Nava Chayoun, 40, who lives on the second floor, said her husband, Yitzhak, ran up the stairs immediately after the rocket struck and saw the body of a woman on the floor. He rescued two children from the same apartment and afterward, she said, she and her family “read psalms.”


Isabel Kershner reported from Kiryat Malachi, Israel, and Fares Akram from Gaza. Reporting was contributed by Rina Castelnuovo from Kiryat Malachi; Mayy El Sheikh and David D. Kirkpatrick from Cairo; Gabby Sobelman from Jerusalem; Rick Gladstone from New York; and Alan Cowell from Paris.



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Major Retailers Start Selling Financial Products, Challenging Banks





On a recent shopping trip to Costco, Lilly Neubauer picked up paper towels, lentils, carrots — and a home mortgage.




While Ms. Neubauer, 27, said she was surprised to find the warehouse club selling financial products, she and her husband saved about $200 a month by refinancing there this year. She also bought home insurance from Costco, she said, again because it was cheaper there.


“It opened us up to the fact that Costco is more than toilet paper,” said Ms. Neubauer, who lives in Dallas.


As the nation’s largest banks stay stingy with credit and a growing portion of the population has no bank at all, major retailers are stepping into the void. Customers can now withdraw cash at an A.T.M. with a prepaid card from Walmart, take out a loan at Home Depot for a kitchen renovation or kick-start a new venture with a small-business loan from Sam’s Club. This year, Walmart even started to test selling a life insurance policy.


Consumer advocates are torn about the growth of this shadow banking industry. Financial products are making it into the hands of people who otherwise might not qualify for them, but these products are not always subject to the same regulations as bank products are. And to turn a profit, retailers generally have to charge more to people with poor credit or none at all.


“These products can come with high fees and few real protections,” said Norma P. Garcia, a senior lawyer with Consumers Union.


For the retailers, banking products are not huge profit centers but a business strategy, meant to put money into customers’ hands and get them buying more.


“You’ve got to remember, Walmart is intended to be a one-stop shop,” said Charles M. Holley Jr., the company’s chief financial officer.


Retailers were once interested in actually becoming banks. Sears, in the 1980s, tried a “socks and stocks” strategy that included acquiring the Dean Witter brokerage firm. And Wal-Mart Stores sought a banking charter for almost a decade before finally abandoning the quest in 2007.


While supermarket chains have leased space to bank branches for years, they are now offering their own products or teaming with small financial firms to do an end run around big banks. While the banks are likely to bristle at such competition, supporters of the retailers say the stores are stepping into areas that banks have abandoned.


“The banks kind of dropped the ball, and in my mind, and in the consumers’ mind, they left it open for different approaches,” said Robert L. Phillips, a professor at Columbia Business School.


Part of the lure is the so-called underbanked population — people who use few, if any, bank services. The Federal Deposit Insurance Corporation estimates that roughly 10 million households in the United States do not use a bank, up from nine million three years ago. And the agency says 24 million more households have a bank account but still use nonbank financial services, like prepaid cards.


Mr. Holley said that 20 to 25 percent of Walmart customers were unbanked.


“The more kinds of services we can offer our core customer like that, the better for them,” he said.


Last month, Walmart unveiled a prepaid card with American Express. The card operates much like a debit card except that it is not attached to a bank account. It comes with free customer-service telephone support, and fees are relatively low, but the account is not backed by the F.D.I.C.


Frustrated with the fees charged by her bank, Nancy Fry, a real estate broker in Logan, Utah, bought a prepaid card from Walmart this year. But this was even worse, she said — she was charged $3 every time she loaded money onto the card. “I really don’t have very much money and can’t afford these fees,” she said.


Consumer advocates complain that prepaid cards are loosely regulated and can cannibalize the money put on them. Consumer lawyers have pushed for greater disclosure of fees and more stringent regulation of the card providers. The government is expected to issue new rules this year.  


Walmart began to test selling a one-year MetLife life insurance policy this year, and customers can wire money or pay bills at any Walmart store.


Costco is also courting customers who are fed up with their banks. “A lot of members think their bank fees are too high, or the trust level has gone down over the years, or they’re having issues with debit and credit cards,” said Jay Smith, Costco’s director of business and financial services.


Costco sells auto and homeowners’ insurance, offers credit card processing for small businesses and began making mortgages in late 2010. It does not make money on the mortgages, which are offered by small lenders, Mr. Smith said. The idea is to get people to renew their store memberships, where Costco makes a large chunk of its profit.


Home Depot, whose customers are mainly homeowners, is trying to increase sales by extending credit to people who would otherwise have trouble getting it. Last year, the company began offering loans of up to $40,000, and this year it extended its no-interest credit card payment terms. “We have the ability to get credit to consumers in this tight credit market, and we wanted people to take advantage of that in a market where people don’t have access to home-equity lines of credit like they used to,” said Dwaine Kimmet, Home Depot’s treasurer and vice president for financial services.


Mr. Kimmet said the loans were especially useful for people who needed emergency items, like a water heater, though shoppers use them for other home décor projects as well.


They are also helpful for Home Depot, whose sales growth has been squeezed by the housing crisis.


Mr. Kimmet said the store loans, unlike home-equity lines of credit, did not require collateral, meaning Home Depot could not seize someone’s house for a failure to pay.


The interest rate on Home Depot’s credit card is higher than that on a typical credit card — 18 percent to 27 percent, depending on credit score, compared with an average of 14.59 percent, according to Bankrate. But Mr. Kimmet said the retailer offered cards to people with credit scores as low as 600, below what many lenders accept.


Other retailers are also trying to make it easier for people to qualify for financial products. Office Depot and Sam’s Club offer loans backed by the government’s Small Business Administration, and both involve quick, one-page initial applications. More than 1,000 Sam’s Club members have used the program since its introduction two years ago, the company said.  


When Kent Prater was about to open a restaurant in Lumberton, N.C., he searched online for loans backed by the Small Business Administration and found that Sam’s Club sold them. He applied online for a $25,000 loan and was approved for a $10,000 loan, with an interest rate of about 10 percent. With a bank, “I think it would probably be a little bit more difficult, because of the environment — the economy and the regulatory environment,” said Mr. Prater, who opened Thai Chili last month.


Paco Underhill, who researches shopper behavior as founder and chief executive of Envirosell, said retailers offering financial products was only the beginning.


“The banks are going to scream bloody murder when retailers try to obtain banking charters,” he said. “But it’s not hard for a retail organization to look across the landscape and say, ‘Who are my customers, and what else could I be selling them?’ ”


Read More..

Drug Compounders Get Help on Capitol Hill





WASHINGTON — Despite two decades of dire health warnings and threats of federal intervention, the specialty drugmakers at the center of the nation’s deadly meningitis outbreak have repeatedly staved off tougher federal oversight with the help of powerful allies in Congress.




Over the years, industry friends like Tom DeLay, the former House Republican leader from Texas, have come to its defense. Even Senator Edward M. Kennedy, regarded as the strongest health care advocate in Congress in recent times, dropped efforts to impose new safeguards.


But the pharmacists known as compounders are now facing their biggest regulatory threat as they confront questions on Wednesday and Thursday at Congressional hearings on the deadly outbreak. The question is whether Congress will move to oversee the niche industry more aggressively.


“A lot of the blame for the meningitis situation lies at Congress’s door,” said Larry D. Sasich, a research pharmacist who has written about compounders’ safety record. For specially mixed drugs that fall into a gray area of federal law, he said, “the protections for your cat or dog are stronger than for your wife and children.”


By Washington standards, the industry’s financial clout is not terribly large. The main trade group, the International Academy of Compounding Pharmacists, has spent $1.1 million on lobbying in the past decade, while major players in the business have given at least $300,000 to candidates since 2008, according to data from the Center for Responsive Politics, a research group in Washington.


But by positioning itself as a more affordable, community-based alternative to huge drug manufacturers, compounders have attracted broad support from politicians. They have become popular among proponents of hormone therapy to slow aging and advocates for the autistic, who often distrust the traditional pharmaceutical industry, and rely on compounders’ tailor-made blends.


If history is a guide, it often takes a disaster to get real change in the law.


In 1938, Congress passed the Food, Drug and Cosmetic Act after a drug company mixed an antibiotic with a toxic solvent and more than 100 people were killed, many of them children. In 1962, it amended that act to effectively create the modern drug approval system after thalidomide, a German drug intended to treat morning sickness in pregnant women, caused severe birth defects in Europe, said Kevin Outterson, an associate professor of law at Boston University.


Experts say the magnitude of the current crisis, in which more than 400 people have been sickened with meningitis and 32 have died, may finally spur action. This week’s hearings are expected to include testimony from the head of the Food and Drug Administration and the head of the Massachusetts pharmacy that produced the tainted drug.


Much of the scrutiny has focused on lax oversight by state boards and the Food and Drug Administration. But public health and drug industry experts say Congress is partly to blame for failing to clearly define the F.D.A.’s authority to police the practice.


A familiar cycle has played out in Washington since the 1990s: Publicity over illnesses or deaths from compounding drugs prompts outrage. Expert witnesses warn of the dangers of an unregulated industry. Proposals to fix the system follow. Then nothing happens.


“The public is at risk, an alarming great risk,” one pharmacist warned in 2003 Senate testimony after one person died and five more fell ill from contaminated medicine in 2002 produced by a South Carolina pharmacy.


Compounding, the practice of mixing medicines for individual patients, has grown in recent decades, helping fill gaps during drug shortages and offering cheaper versions of commercial drugs. But it has also become prone to abuse, with some pharmacies becoming, in effect, mini-drug manufacturers.


While the F.D.A. has clear authority to regulate drug manufacturers, state authorities have the main jurisdiction over pharmacies. Determining which category a company falls into is difficult because compounders are not required to give the F.D.A. access to their books.


Ultimately, stronger regulation has been stymied by sharp opposition from the industry and its defenders in Congress, both Democrats and Republicans, many of whom have compounders in their districts.


In 2008, the F.D.A. challenged what it said were misleading claims by compounders that their hormone therapy for older women was safer and more natural than that of big drug makers; it was met with staunch opposition, including objections from Suzanne Somers, the celebrity anti-aging advocate. The agency eventually prevailed.


Hundreds of members of Congress have attended conferences or taken part in charitable events and letter-writing campaigns organized by the International Academy of Compounding Pharmacists. The trade group said recently that its Congressional supporters had surged in recent years and that compounding had “gone from being a little-known practice to having a strong and steady presence in Washington.”


Texas, home to many compounding pharmacies and their main trade lobbying group, has been an important base of support, producing industry allies like Mr. DeLay and Representative Joe L. Barton, a Texas Republican.


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Drug Compounders Get Help on Capitol Hill





WASHINGTON — Despite two decades of dire health warnings and threats of federal intervention, the specialty drugmakers at the center of the nation’s deadly meningitis outbreak have repeatedly staved off tougher federal oversight with the help of powerful allies in Congress.




Over the years, industry friends like Tom DeLay, the former House Republican leader from Texas, have come to its defense. Even Senator Edward M. Kennedy, regarded as the strongest health care advocate in Congress in recent times, dropped efforts to impose new safeguards.


But the pharmacists known as compounders are now facing their biggest regulatory threat as they confront questions on Wednesday and Thursday at Congressional hearings on the deadly outbreak. The question is whether Congress will move to oversee the niche industry more aggressively.


“A lot of the blame for the meningitis situation lies at Congress’s door,” said Larry D. Sasich, a research pharmacist who has written about compounders’ safety record. For specially mixed drugs that fall into a gray area of federal law, he said, “the protections for your cat or dog are stronger than for your wife and children.”


By Washington standards, the industry’s financial clout is not terribly large. The main trade group, the International Academy of Compounding Pharmacists, has spent $1.1 million on lobbying in the past decade, while major players in the business have given at least $300,000 to candidates since 2008, according to data from the Center for Responsive Politics, a research group in Washington.


But by positioning itself as a more affordable, community-based alternative to huge drug manufacturers, compounders have attracted broad support from politicians. They have become popular among proponents of hormone therapy to slow aging and advocates for the autistic, who often distrust the traditional pharmaceutical industry, and rely on compounders’ tailor-made blends.


If history is a guide, it often takes a disaster to get real change in the law.


In 1938, Congress passed the Food, Drug and Cosmetic Act after a drug company mixed an antibiotic with a toxic solvent and more than 100 people were killed, many of them children. In 1962, it amended that act to effectively create the modern drug approval system after thalidomide, a German drug intended to treat morning sickness in pregnant women, caused severe birth defects in Europe, said Kevin Outterson, an associate professor of law at Boston University.


Experts say the magnitude of the current crisis, in which more than 400 people have been sickened with meningitis and 32 have died, may finally spur action. This week’s hearings are expected to include testimony from the head of the Food and Drug Administration and the head of the Massachusetts pharmacy that produced the tainted drug.


Much of the scrutiny has focused on lax oversight by state boards and the Food and Drug Administration. But public health and drug industry experts say Congress is partly to blame for failing to clearly define the F.D.A.’s authority to police the practice.


A familiar cycle has played out in Washington since the 1990s: Publicity over illnesses or deaths from compounding drugs prompts outrage. Expert witnesses warn of the dangers of an unregulated industry. Proposals to fix the system follow. Then nothing happens.


“The public is at risk, an alarming great risk,” one pharmacist warned in 2003 Senate testimony after one person died and five more fell ill from contaminated medicine in 2002 produced by a South Carolina pharmacy.


Compounding, the practice of mixing medicines for individual patients, has grown in recent decades, helping fill gaps during drug shortages and offering cheaper versions of commercial drugs. But it has also become prone to abuse, with some pharmacies becoming, in effect, mini-drug manufacturers.


While the F.D.A. has clear authority to regulate drug manufacturers, state authorities have the main jurisdiction over pharmacies. Determining which category a company falls into is difficult because compounders are not required to give the F.D.A. access to their books.


Ultimately, stronger regulation has been stymied by sharp opposition from the industry and its defenders in Congress, both Democrats and Republicans, many of whom have compounders in their districts.


In 2008, the F.D.A. challenged what it said were misleading claims by compounders that their hormone therapy for older women was safer and more natural than that of big drug makers; it was met with staunch opposition, including objections from Suzanne Somers, the celebrity anti-aging advocate. The agency eventually prevailed.


Hundreds of members of Congress have attended conferences or taken part in charitable events and letter-writing campaigns organized by the International Academy of Compounding Pharmacists. The trade group said recently that its Congressional supporters had surged in recent years and that compounding had “gone from being a little-known practice to having a strong and steady presence in Washington.”


Texas, home to many compounding pharmacies and their main trade lobbying group, has been an important base of support, producing industry allies like Mr. DeLay and Representative Joe L. Barton, a Texas Republican.


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