Opinion: India Shrugs at Another Gandhi

Kapil Sethi/Associated Press

Rahul Gandhi, center, waves during an event organized by the National Students Union of India in Chandigarh, India, on Oct. 11, 2012.

A WELL-KNOWN Indian fashion designer, who had recently flown home from New York, said to me at a dinner in Delhi: “For the first time in a long time, I didn’t feel like coming back. I felt like it used to be in the old days, when we would go abroad and didn’t want to come back.”

The designer was referring to the malaise that has settled over this once hopeful country. People in India will give you many reasons for it. They will cite the growth rate — once nearing 10 percent, now barely 5 — they will talk of the corruption, in every sector from telecom to land to coal, that has totally discredited Prime Minister Manmohan Singh’s government; they will mention the reforms that never happened. And they are not wrong to talk of these things. But these are only symptoms. Not the cause of the gloom, but emanations from it.

What really ails the world’s largest democracy, and what has caused it to lose its footing at this crucial moment in its development, is that its oldest party, its ruling party, the party that invented dynastic democracy, the Congress Party, has found, in the person of Rahul Gandhi, an abysmal mediocrity for an heir. It makes for such sad reading, this tale of the failed crown prince, that it hardly bears telling, were it not for the fact that it has derailed the aspirations of a billion people.

The story began in 2009, when the Congress Party was re-elected at the head of an alliance of parties. At that point, Mr. Singh, the distinguished architect of India’s economic reforms, had been prime minister for five years. Although there are no term limits on the post, he was already in his late 70s. And his party, which had for so long sought legitimacy in the cult of the Gandhi family, felt it was time to put in place a succession plan: a restoration, after a gap of some two decades, of a Gandhi to the office of prime minister. Mr. Singh was set up as the able regent, Rahul Gandhi — grandson of Indira Gandhi — as the 42-year-old prince in waiting.

Of course — this being a democracy — the heir had to prove himself at the polls. The party, though careful to protect him from having to take full responsibility for an election, wanted him, at the very least, to increase the party’s showing in a major state election or two. They wanted him to display some of that old Gandhi charisma, so that a media only too keen to anoint him anyway would be able to report that the people of India were keener still.

Mr. Gandhi has always come across as a diffident politician. He has turned down the prime minister’s repeated pleas to join the cabinet; he has shied away from projecting himself as his party’s choice for prime minister in 2014; as its general secretary, he has spoken out against dynasty and tried to make his party fairer, less sycophantic. He has, at times, even seemed like a crusader against the very power structure that has bestowed such tremendous unelected power upon him.

All this noblesse oblige would have served as a charming and tasteful backdrop to his rise — an unwilling heir accepting his heavy mantle with a heavy heart. But there was one small problem. In dress rehearsal after dress rehearsal, it became clear that, if anyone was more reluctant to see Rahul Gandhi become prime minister than Rahul Gandhi himself, it was the Indian electorate.

THE party machinery slaved away in state after state. But they could not find a single major election in which Rahul Gandhi was, on the back of his own effort, granted anything resembling a face-saving success. Everywhere he went and, unluckily for him, he went everywhere, he managed to leave the political fortunes of his party either damaged or unchanged.

In Bihar, a state with almost three times the population of California, he succeeded in 2010 in reducing the party’s toehold in an assembly of 243 from 9 seats to 4. Two years later, in Uttar Pradesh, the country’s most populous state, the result was even worse. He toured many of the state’s 400 or so seats, making excited speeches in labored Hindi (never his strong suit) and lavishly promising more handouts, more populist schemes. And yet the Congress Party finished last among the big parties. It lost even in places like Amethi and Rae Bareli, Gandhi family strongholds for decades.

The prince was decent; he was hardworking; he was sincere. But he was, as far as the ballot box went, an unmitigated and un-photo-shoppable disaster.

The author of the memoir “Stranger to History: A Son’s Journey Through Islamic Lands.”

Read More..

Lobbying, a Windfall and a Leader’s Family

The New York Times

Ping An, one of China’s largest financial services companies, is building a 115-story office tower in Shenzhen. The company is a $50 billion powerhouse now worth more than A.I.G., MetLife or Prudential.

SHENZHEN, China — The head of a financially troubled insurer was pushing Chinese officials to relax rules that required breaking up the company in the aftermath of the Asian financial crisis.

The survival of Ping An Insurance was at stake, officials were told in the fall of 1999. Direct appeals were made to the vice premier at the time, Wen Jiabao, as well as the then-head of China’s central bank — two powerful officials with oversight of the industry.

“I humbly request that the vice premier lead and coordinate the matter from a higher level,” Ma Mingzhe, chairman of Ping An, implored in a letter to Mr. Wen that was reviewed by The New York Times.

Ping An was not broken up.

The successful outcome of the lobbying effort would prove monumental.

Ping An went on to become one of China’s largest financial services companies, a $50 billion powerhouse now worth more than A.I.G., MetLife or Prudential. And behind the scenes, shares in Ping An that would be worth billions of dollars once the company rebounded were acquired by relatives of Mr. Wen.

The Times reported last month that the relatives of Mr. Wen, who became prime minister in 2003, had grown extraordinarily wealthy during his leadership, acquiring stakes in tourist resorts, banks, jewelers, telecommunications companies and other business ventures.

The greatest source of wealth, by far, The Times investigation has found, came from the shares in Ping An bought about eight months after the insurer was granted a waiver to the requirement that big financial companies be broken up.

Long before most investors could buy Ping An stock, Taihong, a company that would soon be controlled by Mr. Wen’s relatives, acquired a large stake in Ping An from state-owned entities that held shares in the insurer, regulatory and corporate records show. And by all appearances, Taihong got a sweet deal. The shares were bought in December 2002 for one-quarter of the price that another big investor — the British bank HSBC Holdings — paid for its shares just two months earlier, according to interviews and public filings.

By June 2004, the shares held by the Wen relatives had already quadrupled in value, even before the company was listed on the Hong Kong Stock Exchange. And by 2007, the initial $65 million investment made by Taihong would be worth $3.7 billion.

Corporate records show that the relatives’ stake of that investment most likely peaked at $2.2 billion in late 2007, the last year in which Taihong’s shareholder records were publicly available. Because the company is no longer listed in Ping An’s public filings, it is unclear if the relatives continue to hold shares.

It is also not known whether Mr. Wen or the central bank chief at the time, Dai Xianglong, personally intervened on behalf of Ping An’s request for a waiver, or if Mr. Wen was even aware of the stakes held by his relatives.

But internal Ping An documents, government filings and interviews with bankers and former senior executives at Ping An indicate that both the vice premier’s office and the central bank were among the regulators involved in the Ping An waiver meetings and who had the authority to sign off on the waiver.

Only two large state-run financial institutions were granted similar waivers, filings show, while three of China’s big state-run insurance companies were forced to break up. Many of the country’s big banks complied with the breakup requirement — enforced after the financial crisis because of concerns about the stability of the financial system — by selling their assets in other institutions.

Ping An issued a statement to The Times saying the company strictly complies with rules and regulations, but does not know the backgrounds of all entities behind shareholders. The company also said “it is the legitimate right of shareholders to buy and sell shares between themselves.”

In Beijing, China’s foreign ministry did not return calls seeking comment for this article. Earlier, a Foreign Ministry spokesman sharply criticized the investigation by The Times into the finances of Mr. Wen’s relatives, saying it “smears China and has ulterior motives.”

Read More..

Morsi Urged to Retract Edict to Bypass Judges in Egypt

Tara Todras-Whitehill for The New York Times

A demonstrator takes a breather during protests in downtown Cairo on Saturday.

CAIRO — Egyptian judges and prosecutors struck back on Saturday against an attempt by President Mohamed Morsi to place his decrees above judicial review, vowing to challenge his edict in court and reportedly going on strike in Alexandria.

Abdel Meguid Mahmoud, a prosecutor whom Mr. Morsi is seeking to fire, declared to a crowd of cheering judges at Egypt’s high court that the presidential decree was “null and void.” Mr. Mahmoud, who was appointed by Mr. Morsi’s predecessor, Hosni Mubarak, denounced “the systematic campaign against the country’s institutions in general and the judiciary in particular.”

Outside the court, the police fired tear gas at protesters who were denouncing Mr. Morsi and trying to force their way into the building.

The judicial backlash widened a power struggle over the drafting of a new constitution that has raised alarms about a return to autocracy 22 months after the ouster of Mr. Mubarak.

Mr. Morsi, the Islamist who became Egypt’s first elected president in June, is seeking to assert an authority unchecked by judicial review to forestall a court ruling expected on Dec. 2 that could disband the constitutional assembly and extend by two months the year-end deadline for that body to finish its work.

A high court dissolved an earlier assembly that was to draft a constitution last spring, and Mr. Morsi’s supporters accuse their secular opponents and judges appointed by Mr. Mubarak of trying to delay or derail the transition to democracy to prevent the Islamist majority from taking power.

The president’s opponents, in turn, accuse Mr. Morsi of seizing unchecked authority, noting that he holds executive and legislative power under a vague patchwork of interim constitutional declarations put in place by the military leaders who managed the first 18 months of Egypt’s post-Mubarak transition. The Supreme Constitutional Court dissolved the Islamist-dominated Parliament on the eve of Mr. Morsi’s election.

A council that oversees the judiciary on Saturday denounced Mr. Morsi’s decree, which was issued Thursday, as “an unprecedented attack” on its authority, and urged the president to retract the aspects of the decree circumscribing judicial oversight. State news media reported that judges and prosecutors walked out in Alexandria, and there were other news reports of walkouts in Qulubiya and Beheira, but those could not be confirmed.

In Cairo on Saturday, a coalition of secular opposition leaders and parties called for Mr. Morsi to withdraw his decree and disband the constituent assembly. The groups have long complained about the body’s domination by Islamists.

On Friday night their supporters set up a tent city for an open-ended sit-in in Tahrir Square, the center of the Egyptian revolt, and the groups have called for a demonstration there on Tuesday.

The Muslim Brotherhood, the Islamist group allied with Mr. Morsi, has called for demonstrations Sunday and Tuesday to support his moves as an effort to speed up Egypt’s transition to a constitutional democracy.

Near the square, a few hundred young men engaged in an unrelated battle with the police that has been going on for more than five days. They are demanding retribution against security officers who killed more than 40 people and blinded others with birdshot in clashes a year ago.

The protesters had hung a yellow banner across the street declaring “No Entry to the Brotherhood.” They blame the Muslim Brotherhood for failing to back them during last year’s protests.

On Saturday, most appeared unconcerned, if cynical, about Mr. Morsi’s decree, though some approved of his efforts to fire the Mubarak-appointed prosecutor and retry officials previously acquitted in the killings. “A drop of honey in a pool of poison,” said Hassan el-Masry, 19, who lost an eye during last year’s clashes.

Nevine Ramzy and Mai Ayyad contributed reporting.

Read More..

Gadgetwise Blog: Having a Beer With a Smartphone

Drinking beer used to be simple. But the exploding popularity of craft beer over the past several years has changed that, giving beer drinkers a new world of possibilities — and a range of hard decisions.

Predictably, the ever-expanding roster of oatmeal stouts and vanilla porters has been accompanied by the creation of dozens of beer-related apps. These include local guides to the best pints, inane games, beery social networks and recommendation engines that determine which beers you might like based on what you have enjoyed in the past.

An app released this month, Craft Beer New York, gives local connoisseurs an excellent guide to the city’s bars, breweries and bottle shops ($1.99 for iPhones and other iOS devices; you must be 17 years old to download this and the other Apple beer apps). Its developer, Blue Crow Media, also makes attractive apps focused on coffee. The content for this app comes from Joshua M. Bernstein, a beer writer living in Prospect Heights, Brooklyn, and the author of Brewed Awakening, a book about the craft beer movement.

The app rates 122 bars, 34 shops and 22 breweries. I first tested it out in Astoria, Queens, where I live, and it seemed to get things right without just picking the most obvious places to drink. There were short entries on half a dozen establishments, including specific recommendations on which beers to order.

It is worth noting that this app is different from a guide to bars. Good spots will not show up if they have pedestrian beer selections. At the same time, bars do not automatically get good ratings for having lots of choices. Mr. Bernstein acknowledges that the Beer Authority, a 70-tap bar that recently opened on a stretch of Eighth Avenue in Midtown Manhattan, is “a life preserver for folks working around the Port Authority.” But the app still sticks it with a 2 out of 5 rating because of its unimaginative décor, high prices and a tendency to play lame music.

Mr. Bernstein updates the app with newly opened establishments, and it also has a news tab that includes bulletins on things like how to ensure that an I.P.A. is fresh, or how to help out beer-related businesses affected by Hurricane Sandy. An Android version is due out in early 2013.

One of the more popular beer apps is Untappd, a location-based social-networking app for beer drinkers (free and available for Android and iOS). The app is designed to get people to share their impressions of beers, keeping track of what they liked while also guiding friends and strangers to good bars and brews. The app has an active community, but like any crowdsourced project there is a lot to sift through to find anything useful.

Another way to find new beers to try is to tell an algorithm what you drink and have it determine what else you might like. BrewGene is a nice version of this idea (free and available for Android, iOS or on the Web). It has a truly extensive database. I recently ordered a Goose Island I.P.A. from a bar, but when I went to enter it into the app found that there were five different beers with that name. I rated a few beers from the app’s top 100 list, and it began generating credible suggestions for me. The app’s ability to point me toward an establishment that would serve me these beers is lacking, however. Its “Places” function pulled in a seemingly random selection of nearby bars, bodegas and restaurants. There’s supposed to be a beer menu for each establishment, but all the ones I got were blank.

Have a favorite New York City app? Send tips via e-mail to appcity@nytimes.com or via Twitter to @joshuabrustein.

Read More..

Indian Prostitutes’ New Autonomy Imperils AIDS Fight

MUMBAI, India — Millions once bought sex in the narrow alleys of Kamathipura, a vast red-light district here. But prostitutes with inexpensive mobile phones are luring customers elsewhere, and that is endangering the astonishing progress India has made against AIDS.

Indeed, the recent closings of hundreds of ancient brothels, while something of an economic victory for prostitutes, may one day cost them, and many others, their lives.

“The place where sex happens turns out to be an important H.I.V. prevention point,” said Saggurti Niranjan, program associate of the Population Council. “And when we don’t know where that is, we can’t help stop the transmission.”

Cellphones, those tiny gateways to modernity, have recently allowed prostitutes to shed the shackles of brothel madams and strike out on their own. But that independence has made prostitutes far harder for government and safe-sex counselors to trace. And without the advice and free condoms those counselors provide, prostitutes and their customers are returning to dangerous ways.

Studies show that prostitutes who rely on cellphones are more susceptible to H.I.V. because they are far less likely than their brothel-based peers to require their clients to wear condoms.

In interviews, prostitutes said they had surrendered some control in the bedroom in exchange for far more control over their incomes.

“Now, I get the full cash in my hand before we start,” said Neelan, a prostitute with four children whose side business in sex work is unknown to her husband and neighbors. (Neelan is a professional name, not her real one.)

“Earlier, if the customer got scared and didn’t go all the way, the madam might not charge the full amount,” she explained. “But if they back out now, I say that I have removed all my clothes and am going to keep the money.”

India has been the world’s most surprising AIDS success story. Though infections did not appear in India until 1986, many predicted the nation would soon become the epidemic’s focal point. In 2002, the C.I.A.’s National Intelligence Council predicted that India would have as many as 25 million AIDS cases by 2010. Instead, India now has about 1.5 million.

An important reason the disease never took extensive hold in India is that most women here have fewer sexual partners than in many other developing countries. Just as important was an intensive effort underwritten by the World Bank and the Bill and Melinda Gates Foundation to target high-risk groups like prostitutes, gay men and intravenous drug users.

But the Gates Foundation is now largely ending its oversight and support for AIDS prevention in India, just as efforts directed at prostitutes are becoming much more difficult. Experts say it is too early to identify how much H.I.V. infections might rise.

“Nowadays, the mobility of sex workers is huge, and contacting them is very difficult,” said Ashok Alexander, the former director in India of the Gates Foundation. “It’s a totally different challenge, and the strategies will also have to change.”

An example of the strategies that had been working can be found in Delhi’s red-light district on Garstin Bastion Road near the old Delhi railway station, where brothels have thrived since the 16th century. A walk through dark alleys, past blind beggars and up narrow, steep and deeply worn stone staircases brings customers into brightly lighted rooms teeming with scores of women brushing each other’s hair, trying on new dresses, eating snacks, performing the latest Bollywood dances, tending small children and disappearing into tiny bedrooms with nervous men who come out moments later buttoning their trousers.

A 2009 government survey found 2,000 prostitutes at Garstin Bastion (also known as G. B.) Road who served about 8,000 men a day. The government estimated that if it could deliver as many as 320,000 free condoms each month and train dozens of prostitutes to counsel safe-sex practices to their peers, AIDS infections could be significantly reduced. Instead of broadcasting safe-sex messages across the country — an expensive and inefficient strategy commonly employed in much of the world — it encircled Garstin Bastion with a firebreak of posters with messages like “Don’t take a risk, use a condom” and “When a condom is in, risk is out.”

Surprising many international AIDS experts, these and related tactics worked. Studies showed that condom use among clients of prostitutes soared.

“To the credit of the Indian strategists, their focus on these high-risk groups paid off,” said Dr. Peter Piot, the former executive director of U.N.AIDS and now director of the London School of Hygiene and Tropical Medicine. A number of other countries, following India’s example, have achieved impressive results over the past decade as well, according to the latest United Nations report, which was released last week.

Sruthi Gottipati contributed reporting in Mumbai and New Delhi.

Read More..

Pigeon Code Baffles British Cryptographers

They have eavesdropped on the enemy for decades, tracking messages from Hitler’s high command and the Soviet K.G.B. and on to the murky, modern world of satellites and cyberspace. But a lowly and yet mysterious carrier pigeon may have them baffled.

Britain’s code-breakers acknowledged on Friday that an encrypted handwritten message from World War II, found on the leg of a long-dead carrier pigeon in a household chimney in southern England, has thwarted all their efforts to decode it since it was sent to them last month.

As the bird’s story made headlines, pigeon specialists said they believed it may have been flying home from British units in France at around the time of the D-Day Normandy landings in 1944 when it somehow expired in the chimney at the 17th-century home where it was found in the village of Bletchingley, south of London.

After sustained pressure from pigeon-fanciers, the Britain’s GCHQ code-breaking and communications interception unit in Gloucestershire agreed to try to crack the code. But on Friday the secretive organization, whose initials stand for Government Communications Headquarters, acknowledged that it had been unable to do so.

“The sorts of code that were constructed during operations were designed only to be able to be read by the senders and the recipients,” a historian at GCHQ told the British Broadcasting Corporation.

“Unless we get rather more idea than we have about who sent this message and who it was sent to, we are not going to be able to find out what the underlying code was,” said the historian, who was identified only as Tony under GCHQ’s secrecy protocols.

Code-breakers, he said, believed that there could be two possibilities about the encryption of the message, both of them requiring greater knowledge about the identity of those who devised or used the code.

One possibility, he said, was that it was based on a so-called onetime pad that uses a random set of letters, known only to the sender and the recipient, to convert plain text into code and is then destroyed.

“If it’s only used once and it’s properly random, and it’s properly guarded by the sender and the recipient, it’s unbreakable,” the historian said.

Alternatively, if the message was based on a code book designed specifically for a single operation or mission, GCHQ code-breakers were “unlikely” to crack it, Tony said. “These codes are not designed to be casually or easily broken,” he said.

The pigeon’s skeleton was initially found by David Martin, a now-retired probation officer at his home in Bletchingley, when he was cleaning out a chimney as part of a renovation. The message, identifying the pigeon by the code name 40TW194, had been folded into a small scarlet capsule attached to its leg.

“Without access to the relevant codebooks and details of any additional encryption used, it will remain impossible to decrypt,” GCHQ said in a news release. “Although it is disappointing that we cannot yet read the message brought back by a brave carrier pigeon, it is a tribute to the skills of the wartime code-makers that, despite working under severe pressure, they devised a code that was undecipherable both then and now.”

Mr. Martin said he was skeptical of the idea that GCHQ had been unable to crack the code. “I think there’s something about that message that is either sensitive or does not reflect well” on British special forces operating behind enemy lines in wartime France, he said in a telephone interview. “I’m convinced that it’s an important message and a secret message.”

There was some indication on Friday, though, that GCHQ was not taking 40TW194’s code as seriously as, say, tracking satellite phone communications between militants in the Hindu Kush.

One of the most “helpful” ideas about the code, according to Tony, the GCHQ historian, had come from an unidentified member of the public who suggested that, with Christmas looming and thoughts turning, in the West at least, to a red-robed, white-bearded, reindeer-drawn bearer of gifts skilled at accessing homes through their chimneys, the first two words of the message might be “Dear Santa.”

Read More..

The Shrewd Shopper Carries a Smartphone

Tim Gruber for The New York Times

From left, Tara Niebeling, Sarah Schmidt, Bridget Jewell and Erin Vande Steeg are members of the social media team at the Mall of America in Bloomington, Minn.

Retailers are trying to lure shoppers away from the Internet, where they have increasingly been shopping to avoid Black Friday madness, and back to the stores. The bait is technological tools that will make shopping on the busiest day of the year a little more sane — and give shoppers an edge over their competition.

Those with smartphones in hand will get better planning tools, prices and parking spots. Walmart has a map that shows shoppers exactly where the top Black Friday specials can be found. A Mall of America Twitter feed gives advice on traffic and gifts, and the Macy’s app sends special deals for every five minutes a shopper stays in a store.

“The crazy mad rush to camp out and the crazy mad rush to hit the doorbusters have really made people think, ‘I’m just going to stay home on Black Friday,’ ” said Carey Rossi, editor in chief of ConsumerSearch.com, a review site. “This is going to invite some people back and say, ‘You know what? It doesn’t have to be that crazy.’ ”

Part of the retailers’ strategy is to slap back at online stores like Amazon.com, which last year used apps to pick off shoppers as they browsed in physical stores. But the stores are also recognizing that shopping on the Friday after Thanksgiving need not require an overnight wait in line, a helmet and elbow pads. A smartphone gives shoppers enough of an edge.

“This takes away that frantic Black Friday anxiety,” said Lawrence Fong, co-founder of BuyVia, an app that sends people price alerts and promotions. “While there’s a sport to it, life’s a little too short.”

Denise Fouts, 45, who works repairing fire and water damage in Chandler, Ariz., was already using apps, including Shopkick, Target’s app and one called Black Friday, before Thanksgiving to prepare for Black Friday. “There still are going to be the crowds, but at least I already know ahead of time what I’m going specifically for,” Ms. Fouts said.

Last week, Macy’s released an update to its app with about 300 Black Friday specials and their location. In the Herald Square store, for instance, the $49.99 cashmere sweater specials will be in the Broadway side of the fifth-floor women’s department.

“With the speed that people are shopping with on Black Friday, they need to be really efficient about how they’re spending their time,” said Jennifer Kasper, group vice president for digital media at Macy’s.

When shoppers keep the app open, Macy’s will start sending special deals to the phone every five minutes. The deals are not advertised elsewhere.

Walmart has had an app for several years, but recently introduced an in-store mode, which shows things like the current circular or food tastings when a shopper is near a certain location. Twelve percent of Walmart’s mobile revenue now comes from when a person is inside a store.

For Black Friday, the app will have a map of each store, with the precise location of the top sale items — so planners can determine the best way to run. “The blitz items are not where you think they would be, because for traffic reasons, maybe the hot game console is in the lawn and garden center,” said Gibu Thomas, senior vice president for mobile and digital for Walmart Global eCommerce.

Target is also testing a way-finding feature on its app at stores that include some in Seattle, Chicago and Los Angeles. If a shopper types in an item, the app will give its location.

Other app makers are betting that shoppers want apps that pull in information from many stores.

RedLaser, an eBay app, lets shoppers use their phones to compare prices and recently started using location data to give shoppers personalized promotions when they walk into stores, including items not on store shelves at Best Buy, for instance. RetailMeNot, which offers e-commerce coupons, now has offline coupons that will pop up on users’ cellphones when they step near 500 malls on Black Friday.

“Consumers are not going to download 40 different apps for 40 different stores,” said Cyriac Roeding, co-founder of Shopkick, a location-based app that gives shoppers points, redeemable for perks, when they walk into stores or scan certain items.

For Black Friday, Shopkick is publishing what it calls a little black book with the top doorbusters. Shoppers will earn extra points and rewards for shopping on Black Friday.

Read More..

Documents Show F.D.A.’s Failures in Meningitis Outbreak

Newly released documents add vivid detail to the emerging portrait of the Food and Drug Administration’s ineffective and halting efforts to regulate a Massachusetts company implicated in a national meningitis outbreak that has sickened nearly 500 people and killed 34.

In the documents, released on Tuesday in response to a Freedom of Information Act request, the agency would threaten to bring the full force of its authority down on the company, only to back away, citing lack of jurisdiction.

The company, the New England Compounding Center, at times cooperated with F.D.A. inspectors and promised to improve its procedures, and at other times challenged the agency’s legal authority to regulate it, refused to provide records and continued to ship a drug in defiance of the agency’s concerns.

Some of the documents were summarized last week by Congressional committees that held hearings on the meningitis outbreak. Republicans and Democrats criticized the F.D.A. for failing to act on information about unsafe practices at the company as far back as March 2002.

By law, compounding pharmacies are regulated primarily by the states, but the pharmacies have grown over the years into major suppliers of some of the country’s biggest hospitals. The F.D.A. is asking Congress for stronger, clearer authority to police them, but Republicans have said the agency already has enough power.

Records show that the agency was sometimes slow in pursuing its own inspection findings. In one case involving the labeling and marketing of drugs, the agency issued a warning letter to New England Compounding 684 days after an inspection, a delay that the company’s chief pharmacist complained was so long that some of the letter’s assertions no longer applied to its operations.

The agency said in a statement Wednesday that it “was not the timeline we strive for,” but that much of the delay was because of “our limited, unclear and contested authority in this area.” Because of litigation, it said, there was “significant internal discussion about how to regulate compounders.”

The agency first inspected the company in April 2002 after reports that two patients had become dizzy and short of breath after being injected with a steroid made by the company.

 On the first day of the inspection, Barry Cadden, the chief pharmacist, was cooperative, but the next day, the agency inspectors wrote, Mr. Cadden “had a complete change in attitude & basically would not provide any additional information either by responding to questions or providing records,” adding that he challenged their legal authority to be at his pharmacy at all.

The F.D.A. was back at New England Compounding in October 2002 because of possible contamination of another of its products, methylprednisolone acetate, the same drug involved in the current meningitis outbreak.

 While the F.D.A. had the right to seize an adulterated steroid, officials at the time said that action alone would not resolve the company’s poor compounding practices. In a meeting with Massachusetts regulators, F.D.A. officials left authority in the hands of the state, which “would be in a better position to gain compliance or take regulatory action,” according to a memo by an F.D.A. official summarizing the meeting.

 David Elder, compliance branch director for the F.D.A.’s New England District, warned at the meeting that there was the “potential for serious public health consequences if N.E.C.C.’s compounding practices, in particular those relating to sterile products, are not improved.”

 The company fought back hard, repeatedly questioning the F.D.A.’s jurisdiction. In a September 2004 inspection over concerns that the company was dispensing trypan blue, a dye used for some eye surgeries that had not been approved by the F.D.A., Mr. Cadden told the agency inspector that he had none in stock.

But in the clean room, the inspector noticed a drawer labeled “Trypan Blue,” which contained 189 vials of the medicine.

A few days later, Mr. Cadden was defiant. He told the agency that he was continuing to dispense trypan blue and that there was nothing in the law saying a compounder could not dispense unapproved products.

 The conversation turned testy. “Don’t answer any more questions!” Mr. Cadden told another pharmacy executive, according to the F.D.A.’s report.

Mr. Cadden rejected many of the assertions in the warning letter that finally came in December 2006. The next correspondence from the agency did not come until almost two years later, in October 2008, saying that the agency still had “serious concerns” about the company’s practices, and that failing to correct them could result in seizure of products and an injunction against the company and its principals.

It is not known whether any corrective actions were taken. The agency did not conduct another inspection until the recent meningitis outbreak.

Denise Grady contributed reporting.

Read More..

Documents Show F.D.A.’s Failures in Meningitis Outbreak

Newly released documents add vivid detail to the emerging portrait of the Food and Drug Administration’s ineffective and halting efforts to regulate a Massachusetts company implicated in a national meningitis outbreak that has sickened nearly 500 people and killed 34.

In the documents, released on Tuesday in response to a Freedom of Information Act request, the agency would threaten to bring the full force of its authority down on the company, only to back away, citing lack of jurisdiction.

The company, the New England Compounding Center, at times cooperated with F.D.A. inspectors and promised to improve its procedures, and at other times challenged the agency’s legal authority to regulate it, refused to provide records and continued to ship a drug in defiance of the agency’s concerns.

Some of the documents were summarized last week by Congressional committees that held hearings on the meningitis outbreak. Republicans and Democrats criticized the F.D.A. for failing to act on information about unsafe practices at the company as far back as March 2002.

By law, compounding pharmacies are regulated primarily by the states, but the pharmacies have grown over the years into major suppliers of some of the country’s biggest hospitals. The F.D.A. is asking Congress for stronger, clearer authority to police them, but Republicans have said the agency already has enough power.

Records show that the agency was sometimes slow in pursuing its own inspection findings. In one case involving the labeling and marketing of drugs, the agency issued a warning letter to New England Compounding 684 days after an inspection, a delay that the company’s chief pharmacist complained was so long that some of the letter’s assertions no longer applied to its operations.

The agency said in a statement Wednesday that it “was not the timeline we strive for,” but that much of the delay was because of “our limited, unclear and contested authority in this area.” Because of litigation, it said, there was “significant internal discussion about how to regulate compounders.”

The agency first inspected the company in April 2002 after reports that two patients had become dizzy and short of breath after being injected with a steroid made by the company.

 On the first day of the inspection, Barry Cadden, the chief pharmacist, was cooperative, but the next day, the agency inspectors wrote, Mr. Cadden “had a complete change in attitude & basically would not provide any additional information either by responding to questions or providing records,” adding that he challenged their legal authority to be at his pharmacy at all.

The F.D.A. was back at New England Compounding in October 2002 because of possible contamination of another of its products, methylprednisolone acetate, the same drug involved in the current meningitis outbreak.

 While the F.D.A. had the right to seize an adulterated steroid, officials at the time said that action alone would not resolve the company’s poor compounding practices. In a meeting with Massachusetts regulators, F.D.A. officials left authority in the hands of the state, which “would be in a better position to gain compliance or take regulatory action,” according to a memo by an F.D.A. official summarizing the meeting.

 David Elder, compliance branch director for the F.D.A.’s New England District, warned at the meeting that there was the “potential for serious public health consequences if N.E.C.C.’s compounding practices, in particular those relating to sterile products, are not improved.”

 The company fought back hard, repeatedly questioning the F.D.A.’s jurisdiction. In a September 2004 inspection over concerns that the company was dispensing trypan blue, a dye used for some eye surgeries that had not been approved by the F.D.A., Mr. Cadden told the agency inspector that he had none in stock.

But in the clean room, the inspector noticed a drawer labeled “Trypan Blue,” which contained 189 vials of the medicine.

A few days later, Mr. Cadden was defiant. He told the agency that he was continuing to dispense trypan blue and that there was nothing in the law saying a compounder could not dispense unapproved products.

 The conversation turned testy. “Don’t answer any more questions!” Mr. Cadden told another pharmacy executive, according to the F.D.A.’s report.

Mr. Cadden rejected many of the assertions in the warning letter that finally came in December 2006. The next correspondence from the agency did not come until almost two years later, in October 2008, saying that the agency still had “serious concerns” about the company’s practices, and that failing to correct them could result in seizure of products and an injunction against the company and its principals.

It is not known whether any corrective actions were taken. The agency did not conduct another inspection until the recent meningitis outbreak.

Denise Grady contributed reporting.

Read More..

Israel and Hamas Maintain Cease-Fire, After Push by the U.S. and Egypt

CAIRO — A cease-fire agreed to under intense Egyptian and American pressure between Israel and the Palestinian militant group Hamas to halt eight days of bloody conflict seemed to be holding on Thursday, averting a full-scale Israeli ground invasion of the Gaza Strip without resolving the underlying disputes.

With Israeli forces still massed on the Gaza border, a tentative calm in the fighting descended after the agreement was announced on Wednesday night. Some of the tens of thousands of Israeli reservists called up during the conflagration appeared to be making preparations on Thursday to redeploy away from staging areas along the Gaza border where the Israeli military had mounted a buildup of armor and troops.

The success of the truce will be an early test of how Egypt’s new Islamist government might influence the most intractable conflict in the Middle East.

In southern Israel, the target of more than 1,500 rockets fired from Gaza over the past week, wary residents began to return to routine. But schools within a 25-mile radius of the Palestinian enclave remained closed and thousands of soldiers, mobilized for a possible ground invasion, remained along the Gaza border. The military said that a decision regarding the troop deployment would be made after an assessment of the situation later Thursday.

A rocket alert sounded at the small village of Nativ Haasara near the border with Gaza on Thursday morning, sending residents skeptical from the start about the cease-fire running for shelter. The military said the alert had been a false alarm.

In Gaza, traffic returned to streets that had been deserted, stores and markets opened and workers began the huge task of cleaning up the debris left by days of aerial and naval bombardment. Thousands of Palestinians demonstrated in Gaza in support of the cease-fire as the Hamas leadership emerged from the fighting claiming victory.

Israel Radio said a dozen rockets were fired from Gaza in the first few hours of the cease-fire, but Israeli forces did not respond. In the rival Twitter feeds that offered a cyberspace counterpoint to the exchanges of airstrikes and rockets, the Israel Defense Forces said they had achieved their objectives while the armed Al Qassam Brigades in Gaza said Israeli forces had “raised the white flag.”

After more than a week of nights punctuated by the crash of bombardment and the sound of outgoing missiles, reporters in Gaza said the night had been quiet.

At the same time, Israeli security forces said on Thursday that they detained 55 Palestinian militants in the West Bank after earlier confrontations. The army said the detentions were designed to “continue to maintain order” and to “prevent the infiltration of terrorists into Israeli communities.”

The United States, Israel and Hamas all praised Egypt’s role in brokering the cease-fire as the antagonists pulled back from violence that had killed more than 150 Palestinians and five Israelis over the past week. The deal called for a 24-hour cooling-off period to be followed by talks aimed at resolving at least some of the longstanding grievances between the two sides.

Gazans poured into the streets declaring victory against the far more powerful Israeli military. In Israel, the public reaction was far more subdued. Many residents in the south expressed doubt that the agreement would hold, partly because at least five Palestinian rockets thudded into southern Israel after the cease-fire began.

The one-page memorandum of understanding left the issues that have most inflamed the tensions between the Israelis and the Gazans up for further negotiation. Israel demands long-term border security, including an end to Palestinian missile launching over the border. Hamas wants an end to the Israeli embargo.

The deal demonstrated the pragmatism of Egypt’s new Islamist president, Mohamed Morsi, who balanced public support for Hamas with a determination to preserve the peace with Israel. But it was unclear whether the agreement would be a turning point or merely a lull in the conflict.

The cease-fire deal was reached only through a final American diplomatic push: Secretary of State Hillary Rodham Clinton conferred for hours with Mr. Morsi and the United Nations secretary general, Ban Ki-moon, at the presidential palace here. Hanging over the talks was the Israeli shock at a Tel Aviv bus bombing on Wednesday — praised by Hamas — that recalled past Palestinian uprisings and raised fears of heavy Israeli retaliation. After false hopes the day before, Western and Egyptian diplomats said they had all but given up hope for a quick end to the violence.

David D. Kirkpatrick reported from Cairo, and Jodi Rudoren from Gaza. Reporting was contributed by Fares Akram from Gaza, Isabel Kershner and Ethan Bronner from Jerusalem, Mayy El Sheikh from Cairo, Rick Gladstone from New York, and Alan Cowell from Paris.

Read More..