DealBook: In a Switch, Investors Are Buying European Bank Bonds

LONDON — European bank debt, once an investment pariah, is suddenly popular.

In recent weeks, money managers have been readily buying the new bonds of the region’s financial institutions, deals that just months ago would have seemed unpalatable. Bank of Ireland, which received a bailout in 2010, sold $1.3 billion of bonds on Tuesday and found strong demand. It was the largest offering by an Irish bank without a government guarantee in almost three years.

The gradual thawing of the capital markets is a good sign for the region’s banks. In the midst of the crisis, institutions, especially in troubled economies like Ireland and Portugal, have been struggling to raise money from private investors. The latest deals will help bolster banks’ capital levels and strengthen their balance sheets.

But the bonds could leave investors exposed, especially given the precarious situation in Europe. The sovereign debt crisis continues to weigh on the economy. The financial markets remain volatile. And profit at the region’s banks is flagging.

“It’s a great time to be issuing high-yield debt but not to be investing in it,” said Robin Doumar, managing partner at the private equity firm Park Square Capital.

For now, bondholders are taking comfort in the policy makers’ response to the sovereign debt crisis.

In late August, the European Central Bank began an unlimited bond-buying program aimed at lowering countries’ borrowing costs and breathing life into local economies. By essentially offering a blank check to help Europe’s troubled governments, policy makers calmed short-term fears that some of the region’s banks might need to be bailed out, reviving interest in the companies’ bonds.

“The biggest driver of demand has been the policy responses from the European Central Bank,” said Melissa Smith, head of European high-grade debt capital markets at JPMorgan Chase in London. “It’s provided stability as policy makers have stated their commitment to preserving the euro zone.”

With interest rates at record lows, European bank debt looks especially appealing to investors.

On Thursday, the British bank Barclays sold $3 billion of 10-year bonds at 7.6 percent. The Portuguese lender Banco Espírito Santo recently issued $958 million worth of debt at 5.9 percent.

By comparison, a 10-year Treasury is paying 1.8 percent. Germany has offered a negative yield on some of its sovereign debt maturities this year.

Even the yields on junk bonds, the risky corporate debt that pays high interest rates, are coming down as investors pile into such securities. The average yield is now just 5.8 percent, according to a Bank of America Merrill Lynch index. Historically, they have paid 10 percent or even more.

“There’s been a huge contraction,” said Robert Ellison, head of European debt capital markets for financial institutions at UBS in London.

The industry has been quick to capitalize on investors’ desperate hunt for returns. Banks in Europe have issued a combined $318 billion of unsecured debt so far this year, almost triple the amount raised by their American counterparts, according to the data provider Dealogic.

The capital markets are being discerning. This year, well-financed companies in Northern Europe, like Nordea Bank of Sweden, have been able to sell the largest lots of bonds at relatively reasonable rates. Smaller banks, particularly in Southern Europe, have had to offer investors better rates to win support for their bond deals.

Even so, it is a stark contrast from almost a year ago. With the capital markets paralyzed, the European Central Bank then had to step in to stabilize the banks, offering $1.3 trillion in short-term, low-cost loans to financial companies.

As they find renewed interest from private investors, European banks can more easily raise money, fortifying their balance sheets in case of unexpected losses. At regulators’ behest, financial institutions in the region have been increasing their capital levels.

But bond investors, in their thirst for yield, may be overlooking signs of potential trouble.

Barclays, for instance, sold a controversial type of debt, known as contingent convertible bonds. With these so-called CoCo bonds, investors can be wiped out if the bank’s capital falls below a certain threshold. While Barclays’ balance sheet is in good shape, bondholders’ willingness to accept such conditions highlights the risks in the market. Traditional bondholders can usually recoup at least some of their principal even if a company goes bankrupt.

At the same time, many European financial institutions are still in fragile shape. The Bank of Ireland, in which the Irish government still has a small stake, is struggling to divest itself of many risky loans that it made before the financial crisis. Portugal’s economy is also expected to contract 3 percent this year, which will probably depress the earnings of Banco Espírito Santo.

The question for investors is whether the reward is worth the risk.

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Alzheimer’s Tied to Mutation Harming Immune Response

Alzheimer’s researchers and drug companies have for years concentrated on one hallmark of Alzheimer’s disease: the production of toxic shards of a protein that accumulate in plaques on the brain.

But now, in a surprising coincidence, two groups of researchers working from entirely different starting points have converged on a mutated gene involved in another aspect of Alzheimer’s disease: the immune system’s role in protecting against the disease. The mutation is suspected of interfering with the brain’s ability to prevent the buildup of plaque.

The discovery, researchers say, provides clues to how and why the disease progresses. The gene, known as TREM2, is only the second found to increase Alzheimer’s risk substantially in older people.

“It points very specifically to a potential metabolic pathway that you could intervene in to change the course of Alzheimer’s disease,” said William Thies, chief medical and scientific officer of the Alzheimer’s Association.

Much work remains to be done before scientists understand precisely how the newly discovered gene mutation leads to Alzheimer’s, but already there are some indications from studies in mice. When the gene is not mutated, white blood cells in the brain spring into action, gobbling up and eliminating the plaque-forming toxic protein, beta amyloid. As a result, Alzheimer’s can be staved off or averted.

But when the gene is mutated, the brain’s white blood cells are hobbled, making them less effective in their attack on beta amyloid.

People with the mutated gene have a threefold to fivefold increase in the likelihood of developing Alzheimer’s disease in old age.

The intact gene, says John Hardy of University College London, “is a safety net.” And those with the mutation, he adds, “are living life without a safety net.” Dr. Hardy is lead author of one of the papers.

The discovery also suggests that a new type of drug could be developed to enhance the gene’s activity, perhaps allowing the brain’s white blood cells to do their work.

“The field is in desperate need of new therapeutic agents,” said Alison Goate, an Alzheimer’s researcher at Washington University in St. Louis who contributed data to Dr. Hardy’s study. “This will give us an alternative approach.”

The fact that two research groups converged on the same gene gives experts confidence in the findings. Both studies were published online Wednesday in The New England Journal of Medicine. “Together they make a good case that this really is an Alzheimer’s gene,” said Gerard Schellenberg, an Alzheimer’s researcher at the University of Pennsylvania who was not involved with the work.

The other gene found to raise the odds that a person will get Alzheimer’s, ApoE4, is much more common and confers about the same risk as the mutated version of TREM2. But it is still not clear why ApoE4, discovered in 1993, makes Alzheimer’s more likely.

Because the mutations in the newly discovered gene are rare, occurring in no more than 2 percent of Alzheimer’s patients, it makes no sense to start screening people for them, Dr. Thies said. Instead, the discovery provides new clues to the workings of Alzheimer’s disease.

To find the gene, a research group led by Dr. Kari Stefansson of deCODE Genetics of Iceland started with a simple question.

“We asked, ‘Can we find anything in the genome that separates those who are admitted to nursing homes before the age of 75 and those who are still living at home at 85?’ ” he said.

Scientists searched the genomes of 2,261 Icelanders and zeroed in on TREM2. Mutations in that gene were more common among people with Alzheimer’s, as well as those who did not have an Alzheimer’s diagnosis but who had memory problems and might be on their way to developing Alzheimer’s.

The researchers confirmed their results by looking for the gene in people with and without Alzheimer’s in populations studied at Emory University, as well as in Norway, the Netherlands and Germany.

The TREM2 connection surprised Dr. Stefansson. Although researchers have long noticed that the brain is inflamed in Alzheimer’s patients, he had dismissed inflammation as a major factor in the disease.

“I was of the opinion that the immune system would play a fairly small role, if any, in Alzheimer’s disease,” Dr. Stefansson said. “This discovery cured me of that bias.”

Meanwhile, Dr. Hardy and Rita Guerreiro at University College London, along with Andrew Singleton at the National Institute on Aging, were intrigued by a strange, rare disease. Only a few patients had been identified, but their symptoms were striking. They had crumbling bones and an unusual dementia, sclerosing leukoencephalopathy.

“It’s a weird disease,” Dr. Hardy said.

He saw one patient in her 30s whose brain disease manifested in sexually inappropriate behavior. Also, her bones kept breaking. The disease was caused by mutations that disabled both the copy of TREM2 that she had inherited from her mother and the one from her father.

Eventually the researchers searched for people who had a mutation in just one copy of TREM2. To their surprise, it turned out that these people were likely to have Alzheimer’s disease.

They then asked researchers around the world who had genetic data from people with and without Alzheimer’s to look for TREM2 mutations.

“Sure enough, they had good evidence,” Dr. Hardy said. The mutations occurred in one-half of 1 percent of the general population but in 1 to 2 percent of patients with Alzheimer’s disease.

“That is a big effect,” Dr. Hardy said.

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Alzheimer’s Tied to Mutation Harming Immune Response

Alzheimer’s researchers and drug companies have for years concentrated on one hallmark of Alzheimer’s disease: the production of toxic shards of a protein that accumulate in plaques on the brain.

But now, in a surprising coincidence, two groups of researchers working from entirely different starting points have converged on a mutated gene involved in another aspect of Alzheimer’s disease: the immune system’s role in protecting against the disease. The mutation is suspected of interfering with the brain’s ability to prevent the buildup of plaque.

The discovery, researchers say, provides clues to how and why the disease progresses. The gene, known as TREM2, is only the second found to increase Alzheimer’s risk substantially in older people.

“It points very specifically to a potential metabolic pathway that you could intervene in to change the course of Alzheimer’s disease,” said William Thies, chief medical and scientific officer of the Alzheimer’s Association.

Much work remains to be done before scientists understand precisely how the newly discovered gene mutation leads to Alzheimer’s, but already there are some indications from studies in mice. When the gene is not mutated, white blood cells in the brain spring into action, gobbling up and eliminating the plaque-forming toxic protein, beta amyloid. As a result, Alzheimer’s can be staved off or averted.

But when the gene is mutated, the brain’s white blood cells are hobbled, making them less effective in their attack on beta amyloid.

People with the mutated gene have a threefold to fivefold increase in the likelihood of developing Alzheimer’s disease in old age.

The intact gene, says John Hardy of University College London, “is a safety net.” And those with the mutation, he adds, “are living life without a safety net.” Dr. Hardy is lead author of one of the papers.

The discovery also suggests that a new type of drug could be developed to enhance the gene’s activity, perhaps allowing the brain’s white blood cells to do their work.

“The field is in desperate need of new therapeutic agents,” said Alison Goate, an Alzheimer’s researcher at Washington University in St. Louis who contributed data to Dr. Hardy’s study. “This will give us an alternative approach.”

The fact that two research groups converged on the same gene gives experts confidence in the findings. Both studies were published online Wednesday in The New England Journal of Medicine. “Together they make a good case that this really is an Alzheimer’s gene,” said Gerard Schellenberg, an Alzheimer’s researcher at the University of Pennsylvania who was not involved with the work.

The other gene found to raise the odds that a person will get Alzheimer’s, ApoE4, is much more common and confers about the same risk as the mutated version of TREM2. But it is still not clear why ApoE4, discovered in 1993, makes Alzheimer’s more likely.

Because the mutations in the newly discovered gene are rare, occurring in no more than 2 percent of Alzheimer’s patients, it makes no sense to start screening people for them, Dr. Thies said. Instead, the discovery provides new clues to the workings of Alzheimer’s disease.

To find the gene, a research group led by Dr. Kari Stefansson of deCODE Genetics of Iceland started with a simple question.

“We asked, ‘Can we find anything in the genome that separates those who are admitted to nursing homes before the age of 75 and those who are still living at home at 85?’ ” he said.

Scientists searched the genomes of 2,261 Icelanders and zeroed in on TREM2. Mutations in that gene were more common among people with Alzheimer’s, as well as those who did not have an Alzheimer’s diagnosis but who had memory problems and might be on their way to developing Alzheimer’s.

The researchers confirmed their results by looking for the gene in people with and without Alzheimer’s in populations studied at Emory University, as well as in Norway, the Netherlands and Germany.

The TREM2 connection surprised Dr. Stefansson. Although researchers have long noticed that the brain is inflamed in Alzheimer’s patients, he had dismissed inflammation as a major factor in the disease.

“I was of the opinion that the immune system would play a fairly small role, if any, in Alzheimer’s disease,” Dr. Stefansson said. “This discovery cured me of that bias.”

Meanwhile, Dr. Hardy and Rita Guerreiro at University College London, along with Andrew Singleton at the National Institute on Aging, were intrigued by a strange, rare disease. Only a few patients had been identified, but their symptoms were striking. They had crumbling bones and an unusual dementia, sclerosing leukoencephalopathy.

“It’s a weird disease,” Dr. Hardy said.

He saw one patient in her 30s whose brain disease manifested in sexually inappropriate behavior. Also, her bones kept breaking. The disease was caused by mutations that disabled both the copy of TREM2 that she had inherited from her mother and the one from her father.

Eventually the researchers searched for people who had a mutation in just one copy of TREM2. To their surprise, it turned out that these people were likely to have Alzheimer’s disease.

They then asked researchers around the world who had genetic data from people with and without Alzheimer’s to look for TREM2 mutations.

“Sure enough, they had good evidence,” Dr. Hardy said. The mutations occurred in one-half of 1 percent of the general population but in 1 to 2 percent of patients with Alzheimer’s disease.

“That is a big effect,” Dr. Hardy 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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Israelis Launch Major Assault on Gaza, Killing Hamas Commander

GAZA — Israel on Wednesday launched one of the most ferocious assaults on Gaza since its invasion four years ago, hitting at least 20 targets in aerial attacks that killed the top military commander of Hamas, drew strong condemnation from Egypt and escalated the risks of a new war in the Middle East.

The Israelis coupled the intensity of the airstrikes with the threat of another ground invasion and warnings to all Hamas leaders in Gaza to stay out of sight or risk the same fate as the Hamas military commander, Ahmed al-Jabari, who was killed in a pinpoint airstrike as he was traveling by car down a Gaza street. “We recommend that no Hamas operatives, whether low level or senior leaders, show their faces above ground in the days ahead,” the Israel Defense Forces said in a Twitter message.

The ferocity of the airstrikes, which Israel called Operation “Pillar of Defense” in response to repeated rocket attacks by Gaza-based Palestinian militants, provoked rage in Gaza, where Hamas said the airstrikes amounted to war and promised a harsh response. It quickly launched dozens of rockets into southern Israel, including several that struck the city of Beersheba, shattering windows and damaging cars but causing no injuries.

Civil-defense authorities in Israel, anticipating retaliation, raised alert levels early in the day and told residents in southern Israel to take precautions. Many remained indoors or congregated in bomb shelters.

The Hamas-run Health Ministry in Gaza said the Israeli attacks had killed at least five others besides Mr. Jabari, including a baby and a 7-year-old girl, and had wounded at least 40.

The abrupt escalation in hostilities between Israel and Hamas, the militant organization regarded by Israel as a terrorist group sworn to Israel’s destruction, came amid rising tensions between Israel and all of its Arab neighbors. Israel has faced growing lawlessness on its border with the Sinai, including cross-border attacks. It recently fired twice into Syria, which is caught in a civil war, after munitions fell in the Israeli-occupied Golan Heights, and it has absorbed rocket fire from Gaza, which has damaged homes and frightened the population.

Israeli officials had promised a robust response to the rocket fire, but for the moment, at least, opted against a ground invasion and instead chose airstrikes and targeted killings.

The Israeli attacks especially threatened to further complicate Israel’s fragile relations with Egypt, where the Islamist-led government of President Mohamed Morsi, reversing a policy of ousted predecessor Hosni Mubarak, had established closer ties with Hamas and had been acting as a mediator to restore calm between Israel and Gaza-based militant groups.

In the first crisis in Israeli-Egyptian relations since Mr. Morsi came to power, he called the Israeli actions “wanton aggression on the Gaza Strip.” He ordered Egypt’s ambassador to Israel to return home, summoned the Israeli ambassador to protest, and called for emergency meetings of both the United Nations Security Council and the Arab League over the Gaza attacks. Egyptian state media said Foreign Minister Mohamed Amr had “warned Israel against the consequences of escalation and the negative reflections it may have on the security and stability of the region.”

Mr. Morsi’s Freedom and Justice Party, which was founded by the Muslim Brotherhood, posted a video on its Web site of what was described as the burned body of a Palestinian child said to have been killed in the Israeli attacks, in what appeared to be a deliberate attempt to inflame passions. His party also issued a statement saying: “The wanton aggression against Gaza proves that Israel has yet to realize that Egypt has changed and that the Egyptian people who revolted against oppression will not accept assaulting Gaza.”

A spokesman for Hamas, Fawzi Barhoum, said the Israelis had “committed a dangerous crime and broke all redlines,” and that “the Israeli occupation will regret and pay a high price.”

Military officials in Israel, which announced responsibility for the death of Mr. Jabari, later said in a statement that their forces had carried out additional airstrikes in Gaza targeting what they described as “a significant number of long-range rocket sites” owned by Hamas that had stored rockets capable of reaching 25 miles into Israel. The statement said the airstrikes had dealt a “significant blow to the terror organization’s underground rocket-launching capabilities.”

Yisrael Katz, a minister from Israel’s governing Likud Party, issued a statement saying that the operation had sent a message to the Hamas political leaders in Gaza “that the head of the snake must be smashed. Israel will continue to kill and target anyone who is involved in the rocket attacks.”Hamas and medical officials in Gaza said both Mr. Jabari and a companion were killed by the airstrike on his car in Gaza City. Israeli news media said the companion was Mr. Jabari’s son, but there was no immediate confirmation.

Fares Akram reported from Gaza, and Isabel Kershner from Jerusalem. Reporting was contributed by Mayy El Sheikh and David D. Kirkpatrick from Cairo, Gabby Sobelman in Jerusalem, Rina Castelnuovo in Beersheba, Israel, and Rick Gladstone from New York.

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5-Hour Energy Is Cited in 13 Death Reports

Federal officials have received reports of 13 deaths over the last four years that cited the possible involvement of 5-Hour Energy, a highly caffeinated energy shot, according to Food and Drug Administration records and an interview with an agency official.

The disclosure of the reports is the second time in recent weeks that F.D.A. filings citing energy drinks and deaths have emerged. Last month, the agency acknowledged it had received five fatality filings mentioning another popular energy drink, Monster Energy.

Since 2009, 5-Hour Energy has been mentioned in some 90 filings with the F.D.A., including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion, a summary of F.D.A. records reviewed by The New York Times showed.

The filing of an incident report with the F.D.A. does not mean that a product was responsible for a death or an injury or contributed in any way to it. Such reports can be fragmentary in nature and difficult to investigate.

The distributor of 5-Hour Energy, Living Essentials of Farmington Hills, Mich., did not respond to written questions about the filings, and its top executive declined to be interviewed. Living Essentials is a unit of the product’s producer, Innovation Ventures.

However, in a statement, Living Essentials said the product was safe when used as directed and that it was “unaware of any deaths proven to be caused by the consumption of 5-Hour Energy.”

Since the public disclosure of reports about Monster Energy, its producer, Monster Beverage of Corona, Calif., has repeatedly said that its products are safe, adding that they were not the cause of any of the health problems reported to the F.D.A.

Shares of Monster Beverage, which traded above $80 earlier this year, closed Wednesday at $44.74.

The fast-growing energy drink industry is facing increasing scrutiny over issues like labeling disclosures and possible health risks. Some lawmakers are calling on the F.D.A. to increase its regulation of the products and the New York State attorney general is investigating the practices of several producers.

Unlike Red Bull, Monster Energy and some other energy drinks that look like beverages, 5-Hour Energy is sold in a two-ounce bottle referred to as a shot. The company does not disclose the amount of caffeine in each bottle, but a recent article published by Consumer Reports placed that level at about 215 milligrams.

An eight-ounce cup of coffee, depending on how it is made, can contain from 100 to 150 milligrams of caffeine.

The F.D.A. has stated that it does not have sufficient scientific evidence to justify changing how it regulates caffeine or other ingredients in energy products. The issue of how to do so is complicated by the fact that some high-caffeine drinks, like Red Bull, are sold under agency rules governing beverages, while others, like 5-Hour Energy and Monster Energy, are marketed as dietary supplements. The categories have differing ingredient rules and reporting requirements.

In an interview Wednesday, Daniel Fabricant, the director of the agency’s division of dietary supplement programs, said the agency was looking into the death reports that cited 5-Hour Energy. He said that while medical information in such reports could rule out a link with the product, other reports could contain insufficient information to determine what role, if any, a supplement might have played.

Mr. Fabricant said that the 13 fatality reports that mentioned 5-Hour Energy had all been submitted to the F.D.A. by Living Essentials. Since late 2008, producers of dietary supplements are required to notify the F.D.A. when they become aware of a death or serious injury that may be related to their product.

Currently, the agency does not publicly disclose adverse event filings about dietary supplements like 5-Hour Energy. Companies that market energy drinks as beverages are not required to make such reports to the agency, although they can do so voluntarily, Mr. Fabricant said.

Along with caffeine, 5-Hour Energy contains other ingredients, like very high levels of certain B vitamins and an amino acid called taurine.

Reached by telephone, the chief executive of the Living Essentials, Manoj Bhargava, declined to discuss the filings and said he believed an article about the reports would cast the company in a negative light.

“I am not interested in making any comment,” Mr. Bhargava said.

Subsequently, the company issued a statement that said, among other things, that it took “reports of any potential adverse event tied to our products very seriously,” adding that the company complied “with all of our reporting requirements” to the F.D.A.

The company also stated that it marketed 5-Hour Energy to “hardworking adults who need an extra boost of energy.” The product’s label recommends that it not be used by woman who are pregnant or by children under 12 years of age.

The number of reports filed with the F.D.A. that mention 5-Hour Energy appears particularly striking. In 2010, for example, the F.D.A. received a total of 17 fatality reports that mentioned a dietary supplement or a weight loss product, two broad categories that cover more than 50,000 products, according to Mr. Fabricant, the F.D.A. official.

He added that it was difficult to put the volume of 5-Hour Energy filings into context because he believed that some supplement manufacturers were probably not following the mandated reporting rules and that consumers and doctors might also be unaware that they can file incident reports with the agency. Last year, the F.D.A. received only 2,000 reports about fatalities or serious injuries that cited dietary supplements and weight loss products, he said.

Another federal agency, the Substance Abuse and Mental Health Services Administration, reported late last year that more than 13,000 emergency room visits in 2009 were associated with energy drinks alone.

Along with Living Essentials, The Times sent queries last week to several producers asking whether they had received reports linking fatalities or serious injuries to their products.

Representatives for two of those companies — Red Bull and Coca-Cola, which sells NOS and Full Throttle — said they were unaware of any such reports. A representative for PepsiCo, which makes Amp, also said it was unaware of any such reports.

In addition to Red Bull, NOS, Full Throttle and Amp are also marketed as beverages, rather than as dietary supplements.

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Kidney Donors Given Mandatory Safeguards

ST. LOUIS — Addressing long-held concerns about whether organ donors have adequate protections, the country’s transplant regulators acted late Monday to require that hospitals thoroughly inform living kidney donors of the risks they face, fully evaluate their medical and psychological suitability, and then track their health for two years after donation.

Enactment of the policies by the United Network for Organ Sharing, which manages the transplant system under a federal contract, followed six years of halting development and debate.

Meeting at a St. Louis hotel, the group’s board voted to establish uniform minimum standards for a field long regarded as a medical and ethical Wild West. The organ network, whose initial purpose was to oversee donation from people who had just died, has struggled at times to keep pace with rapid developments in donations from the living.

“There is no question that this is a major development in living donor protection,” said Dr. Christie P. Thomas, a nephrologist at the University of Iowa and the chairman of the network’s living donor committee.

Yet some donor advocates complained that the measures did not go far enough, and argued that the organ network, in its mission to encourage transplants, has a conflict of interest when it comes to safeguarding donors.

Three years ago, the network issued some of the same policies as voluntary guidelines, only to have the Department of Health and Human Services insist they be made mandatory.

Although long-term data on the subject is scarce, few living kidney donors are thought to suffer lasting physical or psychological effects. Kidney donations, known as nephrectomies, are typically done laparoscopically these days through a series of small incisions. The typical patient may spend only a few nights in a hospital and feel largely recovered after several months.

Kidneys are by far the most transplanted organs, and there have been nearly as many living donors as deceased ones over the last decade. What data is available suggests that those with one kidney typically live as long as those with two, and that the risk of a donor dying during the procedure is roughly 3 in 10,000.

But kidney transplants, like all surgery, can sometimes end in catastrophe.

In May at Montefiore Medical Center in the Bronx, a 41-year-old mother of three died when her aorta was accidentally cut during surgery to donate a kidney to her brother. In other recent isolated cases, patients have received donor kidneys infected with undetected H.I.V. or hepatitis C.

Less clear are any longer-term effects on donors. Research conducted by the United Network for Organ Sharing shows that of roughly 70,000 people who donated kidneys between late 1999 and early 2011, 27 died within two years of medical causes that may — or may not — have been related to donation. For a small number of donors, their remaining kidney failed, and they required dialysis or a transplant.

The number of living donors — 5,770 in 2011 — has dropped 10 percent over the last two years, possibly because the struggling economy has made it difficult for prospective donors to take time off from work to recuperate. With the national kidney waiting list now stretching past 94,000 people, and thousands on the list dying each year, transplant officials have said they must improve confidence in the system so more people will donate.

The average age of donors has been rising, posing additional medical risks. And new ethical questions have been raised by the emergence of paired kidney exchanges and transplant chains started by good Samaritans who give an organ to a stranger.

Brad Kornfeld, who donated a kidney to his father in 2004, told the board that it had been impossible to find good information about what to expect, leaving him to search for answers on unreliable Internet chat rooms. He said he had almost backed out.

“If information is power,” said Mr. Kornfeld, a Coloradan who serves on the living donor committee, “the lack of information is crippling.”

Under the policies approved this week, the organ network will require hospitals to collect medical data, including laboratory test results, on most living donors to study lasting effects. Results must be reported at six months, one year and two years.

Similar regulations have been in place since 2000, but they did not require blood and urine testing, and hospitals were allowed to report donors who could not be found as simply lost.

That happened often. In recent years, hospitals have submitted basic clinical information — like whether donors were alive or dead — for only 65 percent of donors and lab data for fewer than 40 percent, according to the organ network. Although the network holds the authority, no hospital has ever been seriously sanctioned for noncompliance.

“It’s time we put some teeth into our policy,” said Jill McMaster, a board member from Tennessee.

By 2015, transplant programs will have to report thorough clinical information on at least 80 percent of donors and lab results on at least 70 percent. The requirements phase in at lower levels for the next two years.

Dr. Stuart M. Flechner of the Cleveland Clinic, the chairman of a coalition of medical societies that made recommendations to the organ network, said 9 of 10 hospitals would currently not meet the new requirement.

Donna Luebke, a kidney donor from Ohio who once served on the organ network’s board, said the new standards would matter only if enforcement were more rigorous. She noted that the organization was dominated by transplant doctors: “UNOS is nothing but the foxes watching the henhouse,” she said.

Another of the new regulations prescribes in detail the medical and psychological screenings that hospitals must conduct for potential donors. It requires automatic exclusion if the potential donor has diabetes, uncontrolled hypertension or H.I.V., among other conditions.

The new policies also require that hospitals appoint an independent advocate to counsel and represent donors, and that donors receive detailed information in advance about medical, psychological and financial risks.

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Kidney Donors Given Mandatory Safeguards

ST. LOUIS — Addressing long-held concerns about whether organ donors have adequate protections, the country’s transplant regulators acted late Monday to require that hospitals thoroughly inform living kidney donors of the risks they face, fully evaluate their medical and psychological suitability, and then track their health for two years after donation.

Enactment of the policies by the United Network for Organ Sharing, which manages the transplant system under a federal contract, followed six years of halting development and debate.

Meeting at a St. Louis hotel, the group’s board voted to establish uniform minimum standards for a field long regarded as a medical and ethical Wild West. The organ network, whose initial purpose was to oversee donation from people who had just died, has struggled at times to keep pace with rapid developments in donations from the living.

“There is no question that this is a major development in living donor protection,” said Dr. Christie P. Thomas, a nephrologist at the University of Iowa and the chairman of the network’s living donor committee.

Yet some donor advocates complained that the measures did not go far enough, and argued that the organ network, in its mission to encourage transplants, has a conflict of interest when it comes to safeguarding donors.

Three years ago, the network issued some of the same policies as voluntary guidelines, only to have the Department of Health and Human Services insist they be made mandatory.

Although long-term data on the subject is scarce, few living kidney donors are thought to suffer lasting physical or psychological effects. Kidney donations, known as nephrectomies, are typically done laparoscopically these days through a series of small incisions. The typical patient may spend only a few nights in a hospital and feel largely recovered after several months.

Kidneys are by far the most transplanted organs, and there have been nearly as many living donors as deceased ones over the last decade. What data is available suggests that those with one kidney typically live as long as those with two, and that the risk of a donor dying during the procedure is roughly 3 in 10,000.

But kidney transplants, like all surgery, can sometimes end in catastrophe.

In May at Montefiore Medical Center in the Bronx, a 41-year-old mother of three died when her aorta was accidentally cut during surgery to donate a kidney to her brother. In other recent isolated cases, patients have received donor kidneys infected with undetected H.I.V. or hepatitis C.

Less clear are any longer-term effects on donors. Research conducted by the United Network for Organ Sharing shows that of roughly 70,000 people who donated kidneys between late 1999 and early 2011, 27 died within two years of medical causes that may — or may not — have been related to donation. For a small number of donors, their remaining kidney failed, and they required dialysis or a transplant.

The number of living donors — 5,770 in 2011 — has dropped 10 percent over the last two years, possibly because the struggling economy has made it difficult for prospective donors to take time off from work to recuperate. With the national kidney waiting list now stretching past 94,000 people, and thousands on the list dying each year, transplant officials have said they must improve confidence in the system so more people will donate.

The average age of donors has been rising, posing additional medical risks. And new ethical questions have been raised by the emergence of paired kidney exchanges and transplant chains started by good Samaritans who give an organ to a stranger.

Brad Kornfeld, who donated a kidney to his father in 2004, told the board that it had been impossible to find good information about what to expect, leaving him to search for answers on unreliable Internet chat rooms. He said he had almost backed out.

“If information is power,” said Mr. Kornfeld, a Coloradan who serves on the living donor committee, “the lack of information is crippling.”

Under the policies approved this week, the organ network will require hospitals to collect medical data, including laboratory test results, on most living donors to study lasting effects. Results must be reported at six months, one year and two years.

Similar regulations have been in place since 2000, but they did not require blood and urine testing, and hospitals were allowed to report donors who could not be found as simply lost.

That happened often. In recent years, hospitals have submitted basic clinical information — like whether donors were alive or dead — for only 65 percent of donors and lab data for fewer than 40 percent, according to the organ network. Although the network holds the authority, no hospital has ever been seriously sanctioned for noncompliance.

“It’s time we put some teeth into our policy,” said Jill McMaster, a board member from Tennessee.

By 2015, transplant programs will have to report thorough clinical information on at least 80 percent of donors and lab results on at least 70 percent. The requirements phase in at lower levels for the next two years.

Dr. Stuart M. Flechner of the Cleveland Clinic, the chairman of a coalition of medical societies that made recommendations to the organ network, said 9 of 10 hospitals would currently not meet the new requirement.

Donna Luebke, a kidney donor from Ohio who once served on the organ network’s board, said the new standards would matter only if enforcement were more rigorous. She noted that the organization was dominated by transplant doctors: “UNOS is nothing but the foxes watching the henhouse,” she said.

Another of the new regulations prescribes in detail the medical and psychological screenings that hospitals must conduct for potential donors. It requires automatic exclusion if the potential donor has diabetes, uncontrolled hypertension or H.I.V., among other conditions.

The new policies also require that hospitals appoint an independent advocate to counsel and represent donors, and that donors receive detailed information in advance about medical, psychological and financial risks.

Read More..

Free Online Courses to Be Evaluated for Possible College Credit

While massive open online courses, or MOOCs, are still in their early days, the race has begun to integrate them into traditional colleges — by making them eligible for transfer credits, and by putting them to use in introductory and remedial courses.

On Tuesday, the American Council on Education, the leading umbrella group for higher education, and Coursera, a Silicon Valley MOOC provider, announced a pilot project to determine whether some free online courses are similar enough to traditional college courses that they should be eligible for credit.

The council’s credit evaluation process will begin early next year, using faculty teams to begin to assess how much students who successfully complete Coursera MOOCs have learned. Students who want to take the free classes for credit would have to pay a fee to take an identity-verified, proctored exam. If the faculty team deems the course worthy of academic credit, students who do well could pay for a transcript to submit to the college of their choice. Colleges are not required to accept those credits, but similar transcripts are already accepted by 2,000 United States colleges and universities for training courses offered by the military or by employers.

Coursera, founded last year by two Stanford computer professors, Daphne Koller and Andrew Ng, has 33 university partners and nearly two million students, who currently can earn certificates of completion, but not academic credit, for their work.

“I feel strongly that degrees are really valuable to people, and having MOOCs allow for credit down the line will increase the number of students with the confidence and wherewithal to complete degrees,” Professor Koller said. “If you’re a random student from another country, what are your chances of being admitted to a university here? But if you can show you’re a motivated student who’s completing five courses and done well on the proctored exam, I think a university would pay attention.”

The project is being watched closely by higher-education experts who expect MOOCs to broaden access to higher education and bring down the costs.

“With the additional benefits of ACE credit recommendation for Coursera courses, students will have an unprecedented opportunity to obtain recognized credentials for their work,” said William G. Bowen, the former president of Princeton University and the Mellon Foundation, and senior adviser to Ithaka, a nonprofit group devoted to digital technologies in higher education.

Also on Tuesday, the Bill and Melinda Gates Foundation announced 13 grants, totaling more than $3 million, for MOOC research. The grants are intended to encourage the development of MOOCs in introductory courses, like developmental math and writing, to see how they might be integrated into community colleges to bolster completion, and to develop a pathway for MOOC transfer credit.

While there is some overlap between the Coursera project and the Gates grants, only four of the nine schools that received grants are putting their MOOCs on Coursera, while the others use different platforms.

The largest grants go to three groups — the American council, Ithaka and the Association of Public and Land-Grant Universities — that will explore the credit issue, consider a possible consortium for collaborating on digital courseware, and research the University of Maryland’s experience with MOOCs.

“It certainly appears that there is potential here, and we ought to kick all the tires and see what we can learn,” said Molly Corbett Broad, the president of the American council.

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Changing of the Guard: Hu Jintao’s Military Role in China Uncertain as Congress Winds Down

BEIJING — Even as the Communist Party Congress concludes its sweeping leadership transition later this week, the question of whether the departing president, Hu Jintao, will keep his powerful post as head of the military looms as a major unresolved issue, and one of deepest intrigue.

Mr. Hu is scheduled to cede the chairmanship of the ruling party to Vice President Xi Jinping at the end of the congress. But will he cling to a position of considerable influence as the civilian military chief for two more years, and delay the ascension of Mr. Xi to that post? Or will Mr. Hu depart the scene completely?

Competing possibilities have been floated in recent days, with the preponderant view being that Mr. Hu, unlike his two predecessors, Jiang Zemin and Deng Xiaoping, will completely retire rather than stay on as the top overseer of military affairs. That would give Mr. Xi greater influence over the military and a firmer grip on power from the start.

But some insiders still suggest that Mr. Hu, who appears to have lost out to Mr. Jiang, 86, in shaping the new lineup for the top decision-making body, the Politburo Standing Committee, will nonetheless still hold on to the military post for two more years.

Whatever the outcome, the position, known as chairman of the Central Military Commission, is likely to be the last piece of leverage for Mr. Hu as top party officials tussle down to the wire over promotions of protégés and protection of long-held interests. The bargaining over whether Mr. Hu stays or goes is almost certainly fierce, party insiders said Monday.

Mr. Hu could be arguing that if he is to leave the military post then one of his protégés should be added to the Standing Committee, where five of the projected seven seats are believed to have been allotted to Mr. Jiang’s allies. Though considered unlikely, that suggests that the makeup of the Standing Committee could change at the last minute, before the formal announcement expected Thursday.

Some political insiders also point out that Mr. Hu has promoted some of his military allies to senior posts recently, so he can leave confident that he can exercise his influence through them.

A political commentator in Beijing, Chen Ziming, who is following the congress closely, said he believed that Mr. Hu would retire from the commission, although he had not heard a definitive decision.

“I don’t think that Hu Jintao is so full of ambition that he wants to stay on and exert control over Xi Jinping,” Mr. Chen said, “and I don’t think he will have the power to do that.”

Last week, a former Chinese official and businessman agreed that Mr. Hu was likely to step down from the commission, and that he would do so in the interests of modernization of the military in a new era of competition with the United States.

For Mr. Hu to hand the reins of the military to Mr. Xi “accords with Hu’s and other leaders’ interest in institutional progress,” the former official said. “The former practice of waiting for a period before stepping down was a bad habit that created problems.”

There are also conflicting notions of how the competition for influence between Mr. Hu and Mr. Jiang could affect Mr. Hu’s role after the congress. One supporter of Mr. Hu’s said Mr. Jiang, despite what appears to be his antipathy to Mr. Hu, was leaning heavily on his successor to stay on as military chairman, even though Mr. Hu did not want to.

According to this version, proffered by a prominent Chinese businessman with strong ties to Mr. Hu, Mr. Jiang was suggesting that Mr. Hu stay in the top military post so that Mr. Jiang would “look good in the history books.”

Mr. Jiang retired as party secretary in November 2002 and stepped down as state president the next March. But he remained the chief of the military until late 2004, causing undercurrents of grumbling, until Mr. Hu finally took over the commission.

Earlier, Deng Xiaoping stayed on as military chief for two more years after giving up his remaining civilian titles in 1987, a position that allowed him to order the army to crack down on demonstrators in Tiananmen Square in 1989. But unlike Mr. Jiang or Mr. Hu, Mr. Deng had long exercised sweeping authority without holding official titles like party chief or president, so his decision to keep the military post was not as much of a conspicuous effort to retain power in retirement.

“Hu as a person has high integrity, and he doesn’t want to stay on,” the Hu supporter said.

Others have said Mr. Hu will stay on because he wants to. The former Hong Kong chief executive, Tung Chee-hwa, who remains close to the inner leadership in Beijing, said last month in a CNN interview that Mr. Hu would remain as chairman of the commission “for some time.”

But a senior diplomat in Beijing said he understood that Mr. Hu would probably leave, giving Mr. Xi, who has the strong backing of Mr. Jiang, more maneuvering room to set the nation’s agenda as the first among equals in China’s collective leadership. “I’m hearing the Shanghai crowd has won a decisive victory,” the diplomat said about Mr. Jiang and his supporters. “And that includes Hu out of the C.M.C.” Shanghai was Mr. Jiang’s power base before he ascended to the country’s top leadership posts.

Edward Wong and Jonathan Ansfield contributed reporting.

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