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

Mary Calvert/Reuters

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

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

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

Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how they see the federal role. Large-scale compounding has expanded dramatically since the early 1990s, driven by changes in the health care system, including the rise of hospital outsourcing.

“It is very clear that the health care system has evolved and the role of the compounding pharmacies has really shifted,” Dr. Hamburg said in a telephone interview on Tuesday. She said the laws have not kept pace. “We need legislation that reflects the current environment and the known gaps in our state and federal oversight systems.”

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

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

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

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

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

Large-scale compounders play an important role in the health care supply chain when they produce quality products, F.D.A. officials say. They fill gaps during shortages and supply hospitals with products that can be made more safely and cost-effectively in bulk than in individual hospitals. Officials said they wanted to make sure the products made by such suppliers were safe, but were also concerned about disrupting that supply.

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

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

Read More..

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

Mary Calvert/Reuters

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

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

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

Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how they see the federal role. Large-scale compounding has expanded dramatically since the early 1990s, driven by changes in the health care system, including the rise of hospital outsourcing.

“It is very clear that the health care system has evolved and the role of the compounding pharmacies has really shifted,” Dr. Hamburg said in a telephone interview on Tuesday. She said the laws have not kept pace. “We need legislation that reflects the current environment and the known gaps in our state and federal oversight systems.”

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

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

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

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

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

Large-scale compounders play an important role in the health care supply chain when they produce quality products, F.D.A. officials say. They fill gaps during shortages and supply hospitals with products that can be made more safely and cost-effectively in bulk than in individual hospitals. Officials said they wanted to make sure the products made by such suppliers were safe, but were also concerned about disrupting that supply.

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

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

Read More..

Challenging France to Do Business Differently

Pool photo by Bertrand Langlois

President Francois Hollande, at the Élysée Palace this week, turned to the prominent industrialist Louis Gallois for advice on how to put corporate France on a more competitive footing with the rest of Europe.

PARIS — Louis Gallois, one of France’s most influential industrialists, knew he was about to make waves for the country’s Socialist president.

It was late October, and President François Hollande, faced with an alarming deterioration in the economy, had turned to Mr. Gallois for advice on how to put corporate France on a more competitive footing with the rest of Europe.

Mr. Gallois didn’t sugar-coat the message. His report called for a “competitiveness shock” that would require politicians to curb the “cult of regulation” he said was choking business in France.

The report said that unless France relaxed its notoriously rigid labor market, the country would continue on an industrial decline that had destroyed more than 750,000 jobs in a decade and helped shrink France’s share of exports to the European Union to 9.3 percent, from 12.7 percent, during that period. The report also called for cuts to a broad range of business taxes used to pay for big government and France’s expensive social safety net.

But some wonder whether those measures, even if they can be adopted, would suffice. For them, there is a larger question: Can France be fixed?

While the European crisis has made the French acutely aware of the need to modernize the economy, the country may be running short on time. And there are mixed signals on whether the Hollande government is willing to heed the advice.

As details of the report leaked, the French news media went into a frenzy over whether their country — so resistant to change that the government still controls the price of a baguette of bread — was prepared for such upheaval.

Mr. Hollande quickly provided an answer: a competitiveness “pact” between business and government would better suit French society.

As Mr. Hollande’s finance minister, Pierre Moscovici, hastened to explain, “A shock causes trauma, whereas a pact reassures.”

But many observers say reassurance may no longer be an option.

Even the Germans are alarmed: Behind closed doors, Chancellor Angela Merkel and officials in her entourage are said to be worried that a failure by Mr. Hollande to improve competitiveness could ricochet back to the weakening German economy, further stalling what had long been twin engines of growth for Europe.

“The concern is not just that France could be the next candidate affected by turbulence” from the euro crisis, said Lars P. Feld, an economics professor at the University of Freiburg and an adviser to the German government. “The fear is that it doesn’t manage to cope with the loss of competitiveness and therefore produces little growth or perhaps even stagnation for the next few years,” Mr. Feld said. “And that after that, it could become the new sick man of Europe.”

France still has much working in its favor. Second only to Germany as Europe’s biggest economy, and the fifth-largest in the world, France is a wealthy country with a high savings rate, large foreign direct investment and world-class research and development capabilities.

And the interest rate on French 10-year bonds is only about 2 percent. That is much closer to Germany’s rate than to those of the euro zone’s staggering giants, Italy and Spain, which are above 4 percent and 5 percent respectively, as they struggle to clean up their economies.

Yet, last week the French central bank warned that growth would shrink 0.1 percent in the last three months of 2012, after stagnating for most of the year. Last month Moody’s Investors Service followed Standard & Poor’s in stripping France of its triple-A credit rating, saying the government was failing to ignite competitiveness fast enough.

Meanwhile, an ambitious effort Mr. Hollande began shortly after his election in May to cut the deficit to 3 percent next year from 4.5 percent through tax increases and spending cuts may dampen growth further and ratchet up unemployment, which recently neared 11 percent, twice the rate in Germany.

Read More..

India Ink: Indians Outraged Over Rape on Moving Bus in New Delhi

The police said the men were looking for some fun. They had been drinking, having a party, and decided to go on a joy ride. They began circling the capital in a private bus, the police said, when they spotted a couple looking for a ride home. They waved the man and woman onboard and charged them each 36 cents.

And then, the police said, the men beat the couple with an iron rod and repeatedly raped the woman as the bus circled the city. The woman suffered severe injuries to her head and intestines and required multiple operations, local news media reported, indicators of an assault so savage that India’s capital on Tuesday was shaking with public outrage. Protesters encircled a local police station and blocked a major highway. India’s Parliament erupted in angry protests and condemnation.

“A terrible, terrible atrocity has happened,” Renuka Chowdhary, a member of Parliament, said Tuesday during a raucous session in the upper house. “I am not going to allow this incident to become another statistic.”

Sushma Swaraj, the leader of the opposition in the lower house, demanded that the death penalty be imposed for rapists. “She will live her whole life as a living corpse if she survives,” Ms. Swaraj said of the victim. “Why should there not be the death penalty in such a case?”

The attack is the latest grisly sexual assault in northern India, many of them occurring in the national capital, now often described in the media as India’s rape capital. Horrific cases of violence against women seem to happen with disturbing regularity. In one highly publicized case in October, a 16-year-old girl in the neighboring state of Haryana was raped repeatedly by a group of eight men, perhaps more, who filmed the assault on their cellphones and threatened to kill her if she told anyone. But the family came forward after the videos circulated and her father killed himself by drinking pesticide.

The latest attack occurred on Sunday evening, in the southern rim of the capital. The woman, a 23-year-old medical student, had been out with a male friend; Indian news media reported that they had seen a film together. It was about 9:10 p.m., and the police said the couple were trying to find a ride to a city neighborhood known as Palam. A bus pulled over, and they boarded.

New Delhi has a mix of public and private buses serving more than seven million people every day. The police said the man and woman were tricked into believing that the bus was part of the city’s public fleet: one of the suspects was posing as a conductor, calling out for passengers. Instead, the bus was part of a fleet owned by a private charter company. One of the suspects worked for the company by day, driving a bus for a private school.

As the bus began moving, three young men confronted the couple and began harassing the woman, the police said. Her friend tried to intervene, but they beat him with an iron rod and then repeatedly raped the woman, the police said.

Eventually, the two were stripped of their clothing and thrown out of the bus onto a national highway on the southern outskirts of the capital.

In a briefing on Tuesday afternoon, the Delhi police commissioner, Neeraj Kumar, said the suspects had taken the bus after an evening of drinking and eating. “The idea was to have fun,” he said.

The police said they had arrested four of the six suspects in the case, based on evidence from closed-circuit surveillance cameras. The commissioner said the courts would be asked to “fast track” the case, while prosecutors are expected to seek the maximum sentence of life in prison.

The woman is being treated at Safdarjung Hospital in New Delhi, and regained consciousness on Tuesday, local media reported. She is communicating through writing.

Across New Delhi on Tuesday, women’s groups and students organized protests to demand better security, at one point shutting down the city’s outer ring road, a major route. Several hundred other protesters gathered around the police station where the complaint was filed, holding placards and chanting slogans.

“This is an expression of our horror and anger and discontent at how things are,” said Komal, a doctoral student at Jawaharlal Nehru University who asked to be identified only by her first name. “The government has to take responsibility.”

She said she regularly took buses and often felt unsafe traveling in the capital region. Being sexually harassed is an “everyday experience,” she said. Women are constantly followed by men and groped while on public transportation, she said.

Anupama Ramakrishnan, 33, who is studying sociology at Delhi University, blamed what she called “a deeply held sense of patriarchy” for the attack.

“This is not about sexuality,” she said. “It is about power and violence.”

New Delhi has one of the highest reported rates of crime against women in India, though most experts believe that the official numbers barely hint at the real scale of the problem. Nearly 600 rapes were reported last year, according to the National Crime Records Bureau, more than the reports from Mumbai, Chennai and Bangalore combined. This year, the capital has already recorded more than 600 rapes and may set a record.

In northern India, reports of rape are often followed by questions about the victim’s behavior, and even accusations that she provoked the assault. On Tuesday, some of India’s most prominent activists and social commentators took to Twitter to voice their opinions.

“Security in mobility for a woman is the first right she needs to be guaranteed!” wrote Kiran Bedi, once one of India’s highest-ranking female police officers. “Failure to ensure this is clear failure of governance!”

Hari Kumar contributed reporting.

Read More..

Samsung Drops Action to Block Apple in Europe

PARIS — Samsung said Tuesday that it had dropped its request for a ban on sales of certain Apple phones and tablet computers in Europe, a sharp tactical turn in a patent war that the companies have been fighting on multiple fronts around the world.

Samsung, the South Korean electronics giant, had been seeking injunctions in a number of countries, including Britain, France, Germany, Italy and the Netherlands, contending that Apple, Samsung’s biggest rival in the smartphone market, had infringed on Samsung patents.

The move came only a day after a ruling in a related case in San Francisco, where a U.S. District Court judge rejected a request by Apple, which is based in California, for an injunction to block sales of certain Samsung devices. The decision followed a previous jury ruling that Samsung had violated Apple patents.

After the latest twist in the European case, Samsung said it had acted “in the interest of protecting consumer choice.” Analysts said other factors might have been in play, including a possible nudge from the European Commission.

In January, the commission opened a formal antitrust investigation of Samsung’s terms for licensing patents covering wireless technologies. Under a previous agreement, Samsung had pledged to make the patents available to competitors on “fair, reasonable and nondiscriminatory” terms.

“The scope of what was withdrawn precisely matches the area in which the European Commission has been investigating,” said Florian Müller, a patent consultant in Germering, Germany. “It’s not just that the plot is thickening; in my view, there can be no other plausible view than that there is pressure from Brussels.”

The commission had said previously that it was concerned about possible abuse of patents like the ones at issue in the Apple-Samsung injunction request, those covering technologies needed for a device to function. Without some of these “standard essential patents” from Samsung, for example, phones cannot connect to high-speed wireless networks.

“Regulators have been saying, if the patent holders try to abuse these patents, then they are going to get in trouble,” Mr. Müller said.

The commission declined to comment directly on whether there might be a link between Samsung’s announcement Tuesday and the antitrust case in Brussels. “We take note of this development,” said Antoine Colombani, the spokesman for the E.U. competition commissioner, Joaquín Almunia. “Our investigation is ongoing.”

Samsung, meanwhile, said it could not comment on the proceedings. It said it was “fully co-operating with the European Commission.”

“Samsung remains committed to licensing our technologies on fair, reasonable and nondiscriminatory terms, and we strongly believe it is better when companies compete fairly in the marketplace, rather than in court,” it said in a statement.

There has been speculation that Samsung and Apple have been in talks to try to reach a settlement, though the broad scale of the litigation between the two companies, with lawsuits seeking sales bans or damages continuing on several continents, could make that challenging.

“We cannot comment on details of ongoing legal proceedings, but we believe a commercial resolution is achievable,” Samsung said in a statement.

Alan Hely, a spokesman for Apple, declined to comment.

The announcement by Samsung does not end litigation between the two companies in Europe. Samsung said it planned to pursue lawsuits seeking damages from Apple for what it contends is patent infringement.

Apple and Samsung have also been battling over other patents, covering nonessential features of their devices, like design.

Apple, too, has previously secured bans on the sale of certain Samsung products. Last year, for example, a court in Düsseldorf ruled that Samsung could not sell one of its Galaxy tablet devices in Germany because it bore too close a resemblance to the iPad 2 from Apple.

While some analysts cited regulatory pressure as a possible reason for Samsung’s decision Tuesday, others said the company might have decided that the lawsuits were simply a distraction. Samsung’s phones, especially its Galaxy S3, have been selling well.

In the third quarter, the S3 surpassed the iPhone 4S to become the world’s best-selling smartphone, according to Strategy Analytics, a research firm.

“Maybe the market was telling them that they were succeeding and their time was better spent promoting sales of their product,” said Charles Golvin, an analyst at Forrester Research.

James Kanter contributed reporting from Brussels.

Read More..

Samsung Drops Action to Block Apple in Europe

PARIS — Samsung said Tuesday that it had dropped its request for a ban on sales of certain Apple phones and tablet computers in Europe, a sharp tactical turn in a patent war that the companies have been fighting on multiple fronts around the world.

Samsung, the South Korean electronics giant, had been seeking injunctions in a number of countries, including Britain, France, Germany, Italy and the Netherlands, contending that Apple, Samsung’s biggest rival in the smartphone market, had infringed on Samsung patents.

The move came only a day after a ruling in a related case in San Francisco, where a U.S. District Court judge rejected a request by Apple, which is based in California, for an injunction to block sales of certain Samsung devices. The decision followed a previous jury ruling that Samsung had violated Apple patents.

After the latest twist in the European case, Samsung said it had acted “in the interest of protecting consumer choice.” Analysts said other factors might have been in play, including a possible nudge from the European Commission.

In January, the commission opened a formal antitrust investigation of Samsung’s terms for licensing patents covering wireless technologies. Under a previous agreement, Samsung had pledged to make the patents available to competitors on “fair, reasonable and nondiscriminatory” terms.

“The scope of what was withdrawn precisely matches the area in which the European Commission has been investigating,” said Florian Müller, a patent consultant in Germering, Germany. “It’s not just that the plot is thickening; in my view, there can be no other plausible view than that there is pressure from Brussels.”

The commission had said previously that it was concerned about possible abuse of patents like the ones at issue in the Apple-Samsung injunction request, those covering technologies needed for a device to function. Without some of these “standard essential patents” from Samsung, for example, phones cannot connect to high-speed wireless networks.

“Regulators have been saying, if the patent holders try to abuse these patents, then they are going to get in trouble,” Mr. Müller said.

The commission declined to comment directly on whether there might be a link between Samsung’s announcement Tuesday and the antitrust case in Brussels. “We take note of this development,” said Antoine Colombani, the spokesman for the E.U. competition commissioner, Joaquín Almunia. “Our investigation is ongoing.”

Samsung, meanwhile, said it could not comment on the proceedings. It said it was “fully co-operating with the European Commission.”

“Samsung remains committed to licensing our technologies on fair, reasonable and nondiscriminatory terms, and we strongly believe it is better when companies compete fairly in the marketplace, rather than in court,” it said in a statement.

There has been speculation that Samsung and Apple have been in talks to try to reach a settlement, though the broad scale of the litigation between the two companies, with lawsuits seeking sales bans or damages continuing on several continents, could make that challenging.

“We cannot comment on details of ongoing legal proceedings, but we believe a commercial resolution is achievable,” Samsung said in a statement.

Alan Hely, a spokesman for Apple, declined to comment.

The announcement by Samsung does not end litigation between the two companies in Europe. Samsung said it planned to pursue lawsuits seeking damages from Apple for what it contends is patent infringement.

Apple and Samsung have also been battling over other patents, covering nonessential features of their devices, like design.

Apple, too, has previously secured bans on the sale of certain Samsung products. Last year, for example, a court in Düsseldorf ruled that Samsung could not sell one of its Galaxy tablet devices in Germany because it bore too close a resemblance to the iPad 2 from Apple.

While some analysts cited regulatory pressure as a possible reason for Samsung’s decision Tuesday, others said the company might have decided that the lawsuits were simply a distraction. Samsung’s phones, especially its Galaxy S3, have been selling well.

In the third quarter, the S3 surpassed the iPhone 4S to become the world’s best-selling smartphone, according to Strategy Analytics, a research firm.

“Maybe the market was telling them that they were succeeding and their time was better spent promoting sales of their product,” said Charles Golvin, an analyst at Forrester Research.

James Kanter contributed reporting from Brussels.

Read More..

Observatory: Fossils of New Species Discovered in England

University of Leicester

A view of Pauline avibella, a shrmplike marine creature, from a computer-generated model.

A tiny, fossilized crustacean that lived 425 million years ago has been discovered, remarkably intact, in a rock formation in Herefordshire, England. Paleontologists say it represents a new genus and species, belonging to a class of shrimplike marine creatures called ostracods.

Despite their age, the two specimens were well preserved. They included the shell and the soft parts of the animal, including its body, limbs, eyes, gills and alimentary system.

“It gives us a really special insight into the biology of these animals,” said David Siveter of the University of Leicester in England. He and colleagues from the University of Oxford, Imperial College and Yale discuss the findings in the journal Proceedings of the Royal Society B.

The researchers determined that the animal had large eyes and seven pairs of limbs, with the front two pairs adapted for swimming.

It probably used these limbs to swim near the water’s bottom rather than in the water column, Dr. Siveter said.

Analyzing the fragile fossil posed a challenge. “We couldn’t grab it from the rock because it’s so delicate and small,” Dr. Siveter said. “And we couldn’t X-ray it because there wasn’t enough density contrast between the rock and the fossil.”

So the researchers used physical tomography, grinding minute slices off the fossils and capturing an image of each new section. The process, permitted by international guidelines for establishing new species, destroys the fossils themselves but yields detailed data to produce a computer-generated model.

The crustacean is named Pauline avibella, after Dr. Siveter’s deceased wife, Pauline.

Read More..

News Analysis: Message, if Murky, From U.S. to the World

At the global treaty conference on telecommunications here, the United States got most of what it wanted. But then it refused to sign the document and left in a huff.

What was that all about? And what does it say about the future of the Internet — which was virtually invented by the United States but now has many more users in the rest of the world?

It may mean little about how the Internet will operate in the coming years. But it might mean everything about the United States’ refusal to acknowledge even symbolic global oversight of the network.

The American delegation, joined by a handful of Western allies, derided the treaty as a threat to Internet freedom. But most other nations signed it. And other participants in the two weeks of talks here were left wondering on Friday whether the Americans had been negotiating in good faith or had planned all along to engage in a public debate only to make a dramatic exit, as they did near midnight on Thursday as the signing deadline approached.

The head of the American delegation, Terry Kramer, announced that it was “with a heavy heart” that he could not “sign the agreement in its current form.” United States delegates said the pact could encourage censorship and undermine the existing, hands-off approach to Internet oversight and replace it with government control.

Anyone reading the treaty, though, might be puzzled by these assertions. “Internet” does not appear anywhere in the 10-page text, which deals mostly with matters like the fees that telecommunications networks should charge one another for connecting calls across borders. After being excised from the pact at United States insistence, the I-word was consigned to a soft-pedaled resolution that is attached to the treaty.

The first paragraph of the treaty states: “These regulations do not address the content-related aspects of telecommunications.” That convoluted phrasing was understood by all parties to refer to the Internet, delegates said, but without referring to it by name so no one could call it an Internet treaty.

A preamble to the treaty commits the signers to adopt the regulations “in a manner that respects and upholds their human rights obligations.”

Both of these provisions were added during the final days of haggling in Dubai, with the support of the United States. If anything, the new treaty appears to make it more intellectually challenging for governments like China and Iran to justify their current censorship of the Internet.

What’s more, two other proposals that raised objections from the United States were removed. One of those stated that treaty signers should share control over the Internet address-assignment system — a function now handled by an international group based in the United States. The other, also removed at the Americans’ behest, called for Internet companies like Google and Facebook to pay telecommunications networks for delivering material to users.

Given that the United States achieved many of its stated goals in the negotiations, why did it reject the treaty in an 11th-hour intervention that had clearly been coordinated with allies like Britain and Canada?

In a Dubai conference call with reporters early on Friday, Mr. Kramer cited a few remaining objections, like references to countering spam and to ensuring “the security and robustness of international telecommunications networks.” This wording, he argued, could be used by nefarious governments to justify crackdowns on free speech.

But even Mr. Kramer acknowledged that his real concerns were less tangible, saying it was the “normative” tone of the debate that had mattered most. The United States and its allies, in other words, saw a chance to use the treaty conference to make a strong statement about the importance of Internet freedom. But by refusing to sign the treaty and boycotting the closing ceremony, they made clear that even to talk about the appearance of global rules for cyberspace was a nonstarter.

It may have been grandstanding, but some United States allies in Europe were happy to go along, saying the strong American stand would underline the importance of keeping the Internet open.

Read More..

Aid: African Children Still at Risk of Pneumonia Despite Ceramic Stoves

Small ceramic indoor stoves, such as those sold by women in AIDS self-help groups in Africa, do save fuel and cut down on eye-irritating smoke, a new study has found — but they do not save children from pneumonia.

The study, published in The American Journal of Tropical Medicine and Hygiene, compared 168 households in rural Kenya that used either “upesi jiko” stoves or traditional three-stone indoor fires. The former — the name means “quick stove” in Swahili — has a locally made ceramic firebox that sells for $3. Clay and mud must be built up around it to insulate it and support the pot.

Since it uses less wood, it saves local forests. But it has no chimney, so the smoke stays indoors.

Biweekly visits by researchers found that children in both the stove and open-fire homes got pneumonia equally often. Pneumonia is a leading cause of death for infants in poor countries, and a 2008 study showed that the fine particles and toxic gases in cooking smoke inflame their lungs, doubling the pneumonia risk.

Two years ago, Secretary of State Hillary Rodham Clinton committed $50 million in American aid to help the Global Alliance for Clean Cookstoves get 100 million efficient stoves into households by 2020. But experts are still divided over which stove to pursue; chimneys do not solve all the problems, and stoves with fans burn more cleanly but are expensive and fragile.

Read More..

Aid: African Children Still at Risk of Pneumonia Despite Ceramic Stoves

Small ceramic indoor stoves, such as those sold by women in AIDS self-help groups in Africa, do save fuel and cut down on eye-irritating smoke, a new study has found — but they do not save children from pneumonia.

The study, published in The American Journal of Tropical Medicine and Hygiene, compared 168 households in rural Kenya that used either “upesi jiko” stoves or traditional three-stone indoor fires. The former — the name means “quick stove” in Swahili — has a locally made ceramic firebox that sells for $3. Clay and mud must be built up around it to insulate it and support the pot.

Since it uses less wood, it saves local forests. But it has no chimney, so the smoke stays indoors.

Biweekly visits by researchers found that children in both the stove and open-fire homes got pneumonia equally often. Pneumonia is a leading cause of death for infants in poor countries, and a 2008 study showed that the fine particles and toxic gases in cooking smoke inflame their lungs, doubling the pneumonia risk.

Two years ago, Secretary of State Hillary Rodham Clinton committed $50 million in American aid to help the Global Alliance for Clean Cookstoves get 100 million efficient stoves into households by 2020. But experts are still divided over which stove to pursue; chimneys do not solve all the problems, and stoves with fans burn more cleanly but are expensive and fragile.

Read More..