Fiscal Impasse Leads to Caution After Election

Business leaders and investors on Wall Street reacted cautiously to President Obama’s re-election early Wednesday, warning that the focus would quickly shift from electoral politics to the looming fiscal uncertainty in Washington.

Stocks opened sharply lower in New York, with the Standard & Poor’s 500-stock index down 1.4 percent, while European shares drifted lower and Asian stocks were mixed. While many executives on Wall Street and in other industries favored Mitt Romney, most had already factored in the likelihood of Mr. Obama winning a second term.

“The bottom line is that this looks like a status quo election,” said Dean Maki, chief United States economist at Barclays. “The problem with that is that it doesn’t resolve some of the main sources of uncertainty that are hanging over the economy.”

Companies in some sectors, like hospitals and technology, could see a short-term pop, said Tobias Levkovich, chief United States equity strategist with Citi. Other areas, like financial services as well as coal and mining, could be hurt as investors contemplate a tougher regulatory environment.

Mr. Levkovich predicted that the market would remain volatile between now and mid-January. If Congress and the president cannot come up with a plan to cut the deficit, hundreds of billions in Bush-era tax cuts are set to expire at the beginning of 2013 while automatic spending cuts will sharply cut the defense budget and other programs.

Known as the fiscal cliff, this simultaneous combination of dramatic reductions in government spending and tax increases could push the economy into recession in 2013, economists fear.

In early trading, the Euro Stoxx 50 index, a barometer of euro zone blue chips, fell 1 percent, while the FTSE 100 index in London was 0.4 percent lower.

The S.&P./ASX 200 in Australia closed up 0.7 percent, as did the Hang Seng Index in Hong Kong. The Nikkei 225 stock average in Japan ended trading little changed.

“There’s a huge question mark hanging over what happens in the next few weeks,” said Aric Newhouse, senior vice-president of policy and government relations at the National Association of Manufacturers. “The fiscal cliff is the 800-pound gorilla out there.”

“We can’t wait,” he said. “We think the idea of going over the cliff has to be taken off the table. We’ve got to get to the middle ground.”

For all the anticipation, some observers said the election still left plenty of unanswered questions.

“While we have clarity on the players now, we don’t have any more clarity on what will happen in terms of the fiscal cliff,” Mr. Maki said. “We still have a divided government and they haven’t been able to agree on what to do.”

If the full package of tax increases and spending cuts go into effect, that would equal a $650 billion blow to the economy, Mr. Maki said, equivalent to 4 percent of the gross domestic product.

Mr. Maki envisions a partial compromise, with $200 billion in tax increases and spending cuts. Partly because of that, he estimates, the annual rate of economic growth will dip to 1.5 percent in the first quarter of 2013 from 2.5 percent in the fourth quarter. He predicted that if the full fiscal cliff were to hit, the economy would contract in the first half of 2013.

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Alarm Over India’s Dengue Fever Epidemic

Enrico Fabian for The New York Times

A man at the Yamuna River, an ideal breeding ground for mosquitoes. Filthy standing water abounds in New Delhi. More Photos »

NEW DELHI — An epidemic of dengue fever in India is fostering a growing sense of alarm even as government officials here have publicly refused to acknowledge the scope of a problem that experts say is threatening hundreds of millions of people, not just in India but around the world.

India has become the focal point for a mosquito-borne plague that is sweeping the globe. Reported in just a handful of countries in the 1950s, dengue (pronounced DEN-gay) is now endemic in half the world’s nations.

“The global dengue problem is far worse than most people know, and it keeps getting worse,” said Dr. Raman Velayudhan, the World Health Organization’s lead dengue coordinator.

The tropical disease, though life-threatening for a tiny fraction of those infected, can be extremely painful. Growing numbers of Western tourists are returning from warm-weather vacations with the disease, which has reached the shores of the United States and Europe. Last month, health officials in Miami announced a case of locally acquired dengue infection.

Here in India’s capital, where areas of standing water contribute to the epidemic’s growth, hospitals are overrun and feverish patients are sharing beds and languishing in hallways. At Kalawati Saran Hospital, a pediatric facility, a large crowd of relatives lay on mats and blankets under the shade of a huge banyan tree outside the hospital entrance recently.

Among them was Neelam, who said her two grandchildren were deathly ill inside. Eight-year-old Sneha got the disease first, followed by Tanya, 7, she said. The girls’ parents treated them at home but then Sneha’s temperature rose to 104 degrees, a rash spread across her legs and shoulders, and her pain grew unbearable.

“Sneha has been given five liters of blood,” said Neelam, who has one name. “It is terrible.”

Officials say that 30,002 people in India had been sickened with dengue fever through October, a 59 percent jump from the 18,860 recorded for all of 2011. But the real number of Indians who get dengue fever annually is in the millions, several experts said.

“I’d conservatively estimate that there are 37 million dengue infections occurring every year in India, and maybe 227,500 hospitalizations,” said Dr. Scott Halstead, a tropical disease expert focused on dengue research.

A senior Indian government health official, who agreed to speak about the matter only on the condition of anonymity, acknowledged that official figures represent a mere sliver of dengue’s actual toll. The government only counts cases of dengue that come from public hospitals and that have been confirmed by laboratories, the official said. Such a census, “which was deliberated at the highest levels,” is a small subset that is nonetheless informative and comparable from one year to the next, he said.

“There is no denying that the actual number of cases would be much, much higher,” the official said. “Our interest has not been to arrive at an exact figure.”

The problem with that policy, said Dr. Manish Kakkar, a specialist at the Public Health Foundation of India, is that India’s “massive underreporting of cases” has contributed to the disease’s spread. Experts from around the world said that India’s failure to construct an adequate dengue surveillance system has impeded awareness of the illness’s vast reach, discouraged efforts to clean up the sources of the disease and slowed the search for a vaccine.

“When you look at the number of reported cases India has, it’s a joke,” said Dr. Harold S. Margolis, chief of the dengue branch at the Centers for Disease Control and Prevention in Atlanta.

Neighboring Sri Lanka, for instance, reported nearly three times as many dengue cases as India through August, according to the World Health Organization, even though India’s population is 60 times larger.

Hari Kumar contributed reporting.

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Alarm Over India’s Dengue Fever Epidemic

Enrico Fabian for The New York Times

A man at the Yamuna River, an ideal breeding ground for mosquitoes. Filthy standing water abounds in New Delhi. More Photos »

NEW DELHI — An epidemic of dengue fever in India is fostering a growing sense of alarm even as government officials here have publicly refused to acknowledge the scope of a problem that experts say is threatening hundreds of millions of people, not just in India but around the world.

India has become the focal point for a mosquito-borne plague that is sweeping the globe. Reported in just a handful of countries in the 1950s, dengue (pronounced DEN-gay) is now endemic in half the world’s nations.

“The global dengue problem is far worse than most people know, and it keeps getting worse,” said Dr. Raman Velayudhan, the World Health Organization’s lead dengue coordinator.

The tropical disease, though life-threatening for a tiny fraction of those infected, can be extremely painful. Growing numbers of Western tourists are returning from warm-weather vacations with the disease, which has reached the shores of the United States and Europe. Last month, health officials in Miami announced a case of locally acquired dengue infection.

Here in India’s capital, where areas of standing water contribute to the epidemic’s growth, hospitals are overrun and feverish patients are sharing beds and languishing in hallways. At Kalawati Saran Hospital, a pediatric facility, a large crowd of relatives lay on mats and blankets under the shade of a huge banyan tree outside the hospital entrance recently.

Among them was Neelam, who said her two grandchildren were deathly ill inside. Eight-year-old Sneha got the disease first, followed by Tanya, 7, she said. The girls’ parents treated them at home but then Sneha’s temperature rose to 104 degrees, a rash spread across her legs and shoulders, and her pain grew unbearable.

“Sneha has been given five liters of blood,” said Neelam, who has one name. “It is terrible.”

Officials say that 30,002 people in India had been sickened with dengue fever through October, a 59 percent jump from the 18,860 recorded for all of 2011. But the real number of Indians who get dengue fever annually is in the millions, several experts said.

“I’d conservatively estimate that there are 37 million dengue infections occurring every year in India, and maybe 227,500 hospitalizations,” said Dr. Scott Halstead, a tropical disease expert focused on dengue research.

A senior Indian government health official, who agreed to speak about the matter only on the condition of anonymity, acknowledged that official figures represent a mere sliver of dengue’s actual toll. The government only counts cases of dengue that come from public hospitals and that have been confirmed by laboratories, the official said. Such a census, “which was deliberated at the highest levels,” is a small subset that is nonetheless informative and comparable from one year to the next, he said.

“There is no denying that the actual number of cases would be much, much higher,” the official said. “Our interest has not been to arrive at an exact figure.”

The problem with that policy, said Dr. Manish Kakkar, a specialist at the Public Health Foundation of India, is that India’s “massive underreporting of cases” has contributed to the disease’s spread. Experts from around the world said that India’s failure to construct an adequate dengue surveillance system has impeded awareness of the illness’s vast reach, discouraged efforts to clean up the sources of the disease and slowed the search for a vaccine.

“When you look at the number of reported cases India has, it’s a joke,” said Dr. Harold S. Margolis, chief of the dengue branch at the Centers for Disease Control and Prevention in Atlanta.

Neighboring Sri Lanka, for instance, reported nearly three times as many dengue cases as India through August, according to the World Health Organization, even though India’s population is 60 times larger.

Hari Kumar contributed reporting.

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Social Media Finds a Role in Case Against Zimmerman

MIAMI — When Mark O’Mara agreed to defend George Zimmerman in the Trayvon Martin murder case, one of his first major decisions was to embrace the Internet.

He set up a legal defense Web site for his client, a Twitter page and a Facebook account, all with the purpose of countering what he called the “avalanche of misinformation” about the case and Mr. Zimmerman.

It was a risky move, unorthodox for a criminal defense lawyer, legal experts said, but a bold one. Late last month, the judge in the case, rebuffing the prosecution, allowed Mr. O’Mara to keep the online presence.

In so doing, the judge sanctioned the use of social media in a high-profile murder case that was already steeped in the power of Facebook, Twitter and blogs. Not long after Mr. Martin was shot and killed, protesters took their cues from Facebook and demonstrated across the country. Angry words coursed through Twitter.

Mr. Zimmerman, in hiding, started a Web site to raise money. The Martin family’s lawyers, who made ample use of traditional media, used Twitter to bring attention to Mr. Martin’s death.

Social media is playing a role in the courtroom, too. Mr. O’Mara wants to use Mr. Martin’s Facebook page and Twitter feed to bolster Mr. Zimmerman’s claim of self-defense. But he will most likely face a protracted battle to authenticate the material, in part because Mr. Martin is no longer alive. Last month, the judge allowed Mr. O’Mara to subpoena Twitter and Facebook for the information.

In ways large and small, the State of Florida v. George Zimmerman is serving as a modernized blueprint for deploying social media in a murder case.

“The way the whole case has been playing out in social media is typical of our times, but more typical of civil cases than criminal cases,” said Robert Ambrogi, a lawyer and technology expert who writes a blog on the intersection of the legal profession and social media. “It’s not without precedent, but it’s on the cutting edge.”

In civil cases, lawyers routinely dig up Facebook photos of people claiming to have a back injury dancing atop bars or revealing posts from supposedly faithful spouses.

“In the world of electronic information, the amount of potentially relevant information in discovery has exploded,” said Kenneth Withers, the director of judicial education and content for The Sedona Conference, a nonprofit law and policy research organization, referring to the pretrial exchange of information and evidence between lawyers on both sides. “And with social media, there has been an explosion of an explosion.”

It no longer makes sense for criminal defense lawyers who have tread more cautiously into social media to brush it off or avoid it, legal experts said.

Nicole Black, a co-author of “Social Media for Lawyers,” said criminal lawyers are getting crash courses on how to best use social media to help their clients and themselves.

“There is almost hysteria among the lawyers to understand it and how it’s affecting their practice,” said Ms. Black, who is also the director of business development and community relations at MyCaseInc.com.

Mr. O’Mara said as much in court recently when he pressed for access to Mr. Martin’s Facebook page and for the continued use of the legal defense Web site and its Twitter feed. “This is 2012, and I’m sorry, I used to have the books on the shelf, and those days are long gone,” he said. “We now have an active vehicle for information. I will tell you that today, if every defense attorney is not searching for information on something like this, he will be committing malpractice.”

Mr. Zimmerman, a Hispanic neighborhood watch volunteer in Sanford, Fla., is charged with second-degree murder in the shooting death of Mr. Martin, an unarmed black teenager who was killed in February as he walked to a house where he was staying as a guest.

Mr. O’Mara has been careful to hew to ethical requirements on his Twitter feed and Web site, which he uses to post legal documents, react to developments in the case and raise money for his client. He allows comments to be posted so long as they are not inflammatory. When the Facebook page “devolved into people bickering,” he said, he shut it down.

Social media is difficult to control, which for many is precisely its allure. Last month, Mr. Zimmerman’s brother, Robert Zimmerman Jr., fired off an angry post on Twitter at Natalie Jackson, one of the Martin family’s lawyers.

“My Life’s work = you WILL be held accountable for your words/actions. You A’INT seen NOTHIN’ yet ... I will see U disbarred,” he posted on Twitter.

Mr. O’Mara wrote a reaction on his Web site.

“Regarding Robert Zimmerman Jr.’s media campaign and Twitter comments, Robert is acting on behalf of his family, and he is not acting with the approval or the input of the defense team,” he wrote. He noted that, “The Zimmerman family has been through a lot, and they have been frequently misrepresented in the media, so we do not begrudge Robert for wanting to speak out and set the record straight.”

While Mr. O’Mara has become adept at social media, rattling off the number of Google hits on the words Trayvon Martin and the tally of visits to the legal defense site — 267,089 as of Monday — plunging into the world of Twitter, Facebook and blogs is not a welcome development for all in the courtroom.

“I’m new to this, quite frankly; I’m old,” a prosecutor, Bernie de la Rionda, said as the two sides faced off over social media in the courtroom.

Before long, Judge Debra S. Nelson will have to decide how to handle social media during the trial, which is scheduled to begin on June 10. Some jurors in other cases across the country have taken to posting about the proceedings on Facebook or Twitter, posing a risk of mistrials. Judges have cracked down.

Considering the publicity in the case, Judge Nelson may wind up following the lead of the judge in another high-profile Florida murder trial, that of Casey Anthony, who was acquitted of killing her young daughter. She could sequester the jury members, confiscate their cellphones and laptops, and monitor their calls and computer time.

If Judge Nelson does follow suit, she must be prepared to deal with another juror dilemma: extreme withdrawal.

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Divided U.S. Gives Obama More Time

Doug Mills/The New York Times

Americans voted to give President Obama a second chance to change Washington. More Photos »

Barack Hussein Obama was re-elected president of the United States on Tuesday, overcoming powerful economic headwinds, a lock-step resistance to his agenda by Republicans in Congress and an unprecedented torrent of advertising as a divided nation voted to give him more time.

In defeating Mitt Romney, the president carried Colorado, Iowa, Ohio, New Hampshire, Virginia and Wisconsin, a near sweep of the battleground states, and was holding a narrow advantage in Florida. The path to victory for Mr. Romney narrowed as the night wore along, with Mr. Obama winning at least 303 electoral votes.

A cheer of jubilation sounded at the Obama campaign headquarters in Chicago when the television networks began projecting him as the winner at 11:20 p.m., even as the ballots were still being counted in many states where voters had waited in line well into the night. The victory was far narrower than his historic election four years ago, but it was no less dramatic.

“Tonight in this election, you, the American people, reminded us that while our road has been hard, while our journey has been long, we have picked ourselves up, we have fought our way back,” Mr. Obama told his supporters early Wednesday. “We know in our hearts that for the United States of America, the best is yet to come.”

Mr. Obama’s re-election extended his place in history, carrying the tenure of the nation’s first black president into a second term. His path followed a pattern that has been an arc to his political career: faltering when he seemed to be at his strongest — the period before his first debate with Mr. Romney — before he redoubled his efforts to lift himself and his supporters to victory.

The evening was not without the drama that has come to mark so many recent elections: For more than 90 minutes after the networks projected Mr. Obama as the winner, Mr. Romney held off calling him to concede. And as the president waited to declare victory in Chicago, Mr. Romney’s aides were prepared to head to the airport, suitcases packed, potentially to contest several close results.

But as it became increasingly clear that no amount of contesting would bring him victory, he called Mr. Obama to concede shortly before 1 a.m.

“I wish all of them well, but particularly the president, the first lady and their daughters,” Mr. Romney told his supporters in Boston. “This is a time of great challenges for America, and I pray that the president will be successful in guiding our nation.”

Hispanics made up an important part of Mr. Obama’s winning coalition, preliminary exit poll data showed. And before the night was through, there were already recriminations from Republican moderates who said Mr. Romney had gone too far during the primaries in his statements against those here illegally, including his promise that his get-tough policies would cause some to “self-deport.”

Mr. Obama, 51, faces governing in a deeply divided country and a partisan-rich capital, where Republicans retained their majority in the House and Democrats kept their control of the Senate. His re-election offers him a second chance that will quickly be tested, given the rapidly escalating fiscal showdown.

For Mr. Obama, the result brings a ratification of his sweeping health care act, which Mr. Romney had vowed to repeal. The law will now continue on course toward nearly full implementation in 2014, promising to change significantly the way medical services are administrated nationwide.

Confident that the economy is finally on a true path toward stability, Mr. Obama and his aides have hinted that he would seek to tackle some of the grand but unrealized promises of his first campaign, including the sort of immigration overhaul that has eluded presidents of both parties for decades.

But he will be venturing back into a Congressional environment similar to that of his first term, with the Senate under the control of Democrats and the House under the control of Republicans, whose leaders have hinted that they will be no less likely to challenge him than they were during the last four years.

Michael Cooper contributed reporting.

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Antwerp Journal: Antwerp’s Diamond Industry Facing Challenges

Colin Delfosse for The New York Times

Indian businessmen in the diamond district of Antwerp, Belgium.

ANTWERP, Belgium — Step off the train here and you cannot miss the signs on the stores: Diamond World, Diamond Gallery, Diamond Creations or simply, Diamonds. Of late, there are the banners and posters reading simply, “Antwerp Loves Diamonds.”

Though this Belgian port has had a love affair with diamonds for centuries, of late it seems to be losing some of its passion. For years now, much of the lucrative but labor-intensive business of cutting and polishing stones has been drifting to low-wage centers in the developing world, like Mumbai, Dubai and Shanghai.

More ominously, in recent years, diamond traders have been accused of a range of violations, including tax fraud, money laundering and cheating on customs payments when buying and selling stones.

Local business leaders recognize the threat. This year, they embarked on what local newspapers described as a “charm offensive.” In a 160-page program, titled Project 2020, the World Diamond Center, a trade-promotion group, outlined plans to draw business back to Antwerp by simplifying and accelerating trading via online systems. That, the industry hopes, will win back some of the polishing business lost to Asian countries with new technology, like fully automated diamond polishers, and generally burnish the image of the diamond business in the public’s jaded eye.

“This is our strength,” said Ari Epstein, 36, a lawyer who is chief executive of the World Diamond Center and the son of a diamond trader, whose father emigrated from a village in Romania in the 1960s. “We have the critical mass so that every diamond finds a buyer and seller.”

Antwerp has by no means fallen out of love with the gems. In all, the market employs 8,000 people and creates work indirectly for 26,000 others as insurers, bankers, security guards and drivers. Last year, turnover in the local diamond business amounted to $56 billion, Mr. Epstein said, its best year ever.

While total revenues are expected to drop this year because of the troubled world economy, he acknowledged, a stroll along Hoveniersstraat, or Gardner’s Street, leads through the heart of the market, where almost 85 percent of the world’s uncut diamonds are still traded.

“I come here once a month,” said Sheh Kamliss, a trader in his 30s, who travels from his native India to buy uncut stones and sell polished diamonds. “This is the international market,” he added, chatting with fellow Indian traders outside the Diamond Club of Antwerp, one of many locations where deals are struck.

On any given day but Friday or the Jewish holidays, Hoveniersstraat, with its tiny Sephardic synagogue, is liberally sprinkled with Orthodox Jewish traders, many of them Hasidim.

But their once dominant presence has been squeezed by the arrival of traders from new markets, like Mr. Kamliss. Now people from about 70 nations are present, including Indians, Israelis, Lebanese, Russians, Chinese and others. Along neighboring Lange Herentalsestraat, Rachel’s Kosher Restaurant is now flanked by the Bollywood Indian Restaurant and the Shanti Shop Indian supermarket. In the nearby Jewish quarter, Patel’s Cash & Carry recently installed itself right next to Moszkowitz, the butcher.

Some here say this globalization of the business has opened the door to abuse.

Omega Diamonds, a major market maker, came under investigation and its executives fled Belgium when an employee-turned-whistle-blower revealed in 2006 how Omega had traded diamonds out of Africa for years, avoiding taxes by transacting deals through Dubai, Tel Aviv and Geneva, then moving the profits back to Belgium.

“Because of global changes, the trade routes have changed,” said David Renous, 47, the whistle blower, who is now writing a book on the subject. “New hubs, like Dubai, the Singapore of the Middle East, sometimes close their eyes to criminality.”

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New Drugs for Lipids Set Off Race

LOS ANGELES — A new class of powerful cholesterol-reducing drugs is showing promising results, potentially offering a new option for people who do not respond to medication now on the market, according to studies presented at a conference of heart specialists here on Monday.

Although the final word on the effectiveness of the drugs is still a few years away, the results so far are so promising that pharmaceutical companies are racing to bring them to market.

In early- and middle-stage trials, use of the experimental drugs reduced so-called bad cholesterol by about 40 to 70 percent in a matter of weeks, equivalent to the reduction achieved by the most effective statins like Lipitor. But it appears that the new drugs can be used along with statins, lowering cholesterol even further.

“With these drugs, together with statins, you can get virtually everyone to the goal,” Dr. Frederick Raal of the University of the Witwatersrand, in Johannesburg, South Africa, who presented one of several studies on these new drugs at the American Heart Association’s scientific meeting here.

The most advanced of the drugs, which as a class are called PCSK9 inhibitors, is only now entering the final stages of clinical trials and is not likely to get to market until 2015 at the earliest.

And there are still some caveats. One is that while the drugs lower cholesterol, it has not yet been shown that they actually reduce the risk of heart attacks, strokes or other cardiovascular problems.

Furthermore, many of the studies so far have lasted no more than 12 weeks and involved fewer than 200 people. Far longer and larger studies are needed to show that the drugs would keep working over a lifetime and would be safe.

So far, however, the studies show “quite good safety,” Dr. Peter Wilson of Emory University said in a presentation here discussing the studies. “This is extremely promising.”

The drugs have to be injected, typically every two to four weeks. That means that the PCSK9 inhibitors are not likely to be widely used for “garden variety high cholesterol,” said Dr. Gordon Tomaselli, chief of cardiology at Johns Hopkins.

Still, millions of Americans cannot lower their cholesterol sufficiently using statins alone, providing a market that could reach billions of dollars in annual sales for a successful drug.

Leading the race so far is the team of Sanofi, the big French drug company, and Regeneron Pharmaceuticals, a biotechnology company in Tarrytown, N.Y.

The companies announced Monday that they were beginning a Phase 3 trial — usually the last step before filing for approval — involving 18,000 patients with a recent heart attack or worsening chest pain who cannot lower their cholesterol with statin therapy alone. The patients will inject themselves once every two weeks with either the drug or a placebo, while continuing to take statins.

The study, which will take at least two years, will determine whether the drug, known by the awkward code name SAR236553/REGN727, can reduce the rate of heart attacks, strokes and other cardiovascular problems.

In a midstage study published recently in The New England Journal of Medicine, patients who took the Sanofi drug plus a high dose of atorvastatin, the generic equivalent of Lipitor, had a mean 73 percent reduction in low-density lipoprotein cholesterol, the so-called bad cholesterol, compared with a 17 percent reduction for those taking only the high dose of the statin.

Amgen seems to be next in line, saying it plans to begin Phase 3 trials early next year. Pfizer and Roche have drugs in midstage clinical trials. Others in pursuit include Eli Lilly & Company and Alnylam.

Dr. Evan A. Stein of the Metabolic and Atherosclerosis Research Center in Cincinnati, said that about 10 to 20 percent of patients could not tolerate statins at all, or at least could not tolerate doses high enough to lower cholesterol sufficiently. Their main alternative now is Merck’s Zetia, which reduces cholesterol about 18 percent.

Dr. Stein, who is a consultant to Amgen, presented the results on Monday of a trial of Amgen’s drug, AMG 145, in such patients.

Patients receiving AMG 145 experienced an average reduction in LDL cholesterol after 12 weeks of 41 to 51 percent, depending on the dose. Those who received both AMG 145 and Zetia had an even greater average reduction — 63 percent. By contrast, those who received Zetia and a placebo had a drop in bad cholesterol of only 15 percent.

After 12 weeks, only 7 percent of the patients on Zetia alone reduced LDL to 100 milligrams per deciliter, which is the goal for many people. About 61 percent of those on the highest dose of AMG 145 did so, as did 90 percent on both AMG 145 and Zetia. The trial results were also published online by The Journal of the American Medical Association.

LDL cholesterol is removed from the blood when it binds to LDL receptors on the surface of liver cells, and then is taken inside the cells. PCSK9 — which stands for proprotein convertase subtilisin/kexin type 9 — also binds to the LDL receptor, and when it does so, the receptor is destroyed along with the LDL.

But if PCSK9 does not bind, the receptor can return to the surface of the cell and remove more cholesterol. The drugs, which in general are proteins known as monoclonal antibodies, block PCSK9 from binding to the receptor.

Read More..

New Drugs for Lipids Set Off Race

LOS ANGELES — A new class of powerful cholesterol-reducing drugs is showing promising results, potentially offering a new option for people who do not respond to medication now on the market, according to studies presented at a conference of heart specialists here on Monday.

Although the final word on the effectiveness of the drugs is still a few years away, the results so far are so promising that pharmaceutical companies are racing to bring them to market.

In early- and middle-stage trials, use of the experimental drugs reduced so-called bad cholesterol by about 40 to 70 percent in a matter of weeks, equivalent to the reduction achieved by the most effective statins like Lipitor. But it appears that the new drugs can be used along with statins, lowering cholesterol even further.

“With these drugs, together with statins, you can get virtually everyone to the goal,” Dr. Frederick Raal of the University of the Witwatersrand, in Johannesburg, South Africa, who presented one of several studies on these new drugs at the American Heart Association’s scientific meeting here.

The most advanced of the drugs, which as a class are called PCSK9 inhibitors, is only now entering the final stages of clinical trials and is not likely to get to market until 2015 at the earliest.

And there are still some caveats. One is that while the drugs lower cholesterol, it has not yet been shown that they actually reduce the risk of heart attacks, strokes or other cardiovascular problems.

Furthermore, many of the studies so far have lasted no more than 12 weeks and involved fewer than 200 people. Far longer and larger studies are needed to show that the drugs would keep working over a lifetime and would be safe.

So far, however, the studies show “quite good safety,” Dr. Peter Wilson of Emory University said in a presentation here discussing the studies. “This is extremely promising.”

The drugs have to be injected, typically every two to four weeks. That means that the PCSK9 inhibitors are not likely to be widely used for “garden variety high cholesterol,” said Dr. Gordon Tomaselli, chief of cardiology at Johns Hopkins.

Still, millions of Americans cannot lower their cholesterol sufficiently using statins alone, providing a market that could reach billions of dollars in annual sales for a successful drug.

Leading the race so far is the team of Sanofi, the big French drug company, and Regeneron Pharmaceuticals, a biotechnology company in Tarrytown, N.Y.

The companies announced Monday that they were beginning a Phase 3 trial — usually the last step before filing for approval — involving 18,000 patients with a recent heart attack or worsening chest pain who cannot lower their cholesterol with statin therapy alone. The patients will inject themselves once every two weeks with either the drug or a placebo, while continuing to take statins.

The study, which will take at least two years, will determine whether the drug, known by the awkward code name SAR236553/REGN727, can reduce the rate of heart attacks, strokes and other cardiovascular problems.

In a midstage study published recently in The New England Journal of Medicine, patients who took the Sanofi drug plus a high dose of atorvastatin, the generic equivalent of Lipitor, had a mean 73 percent reduction in low-density lipoprotein cholesterol, the so-called bad cholesterol, compared with a 17 percent reduction for those taking only the high dose of the statin.

Amgen seems to be next in line, saying it plans to begin Phase 3 trials early next year. Pfizer and Roche have drugs in midstage clinical trials. Others in pursuit include Eli Lilly & Company and Alnylam.

Dr. Evan A. Stein of the Metabolic and Atherosclerosis Research Center in Cincinnati, said that about 10 to 20 percent of patients could not tolerate statins at all, or at least could not tolerate doses high enough to lower cholesterol sufficiently. Their main alternative now is Merck’s Zetia, which reduces cholesterol about 18 percent.

Dr. Stein, who is a consultant to Amgen, presented the results on Monday of a trial of Amgen’s drug, AMG 145, in such patients.

Patients receiving AMG 145 experienced an average reduction in LDL cholesterol after 12 weeks of 41 to 51 percent, depending on the dose. Those who received both AMG 145 and Zetia had an even greater average reduction — 63 percent. By contrast, those who received Zetia and a placebo had a drop in bad cholesterol of only 15 percent.

After 12 weeks, only 7 percent of the patients on Zetia alone reduced LDL to 100 milligrams per deciliter, which is the goal for many people. About 61 percent of those on the highest dose of AMG 145 did so, as did 90 percent on both AMG 145 and Zetia. The trial results were also published online by The Journal of the American Medical Association.

LDL cholesterol is removed from the blood when it binds to LDL receptors on the surface of liver cells, and then is taken inside the cells. PCSK9 — which stands for proprotein convertase subtilisin/kexin type 9 — also binds to the LDL receptor, and when it does so, the receptor is destroyed along with the LDL.

But if PCSK9 does not bind, the receptor can return to the surface of the cell and remove more cholesterol. The drugs, which in general are proteins known as monoclonal antibodies, block PCSK9 from binding to the receptor.

Read More..

Silicon Valley Objects to Online Privacy Rule Proposals for Children

Washington is pushing Silicon Valley on children’s privacy, and Silicon Valley is pushing back.

Daniel Rosenbaum for The New York Times

Phyllis H. Marcus, a lawyer for the F.T.C., is leading a team that is updating a privacy rule to require more parental consent.

Apple, Facebook, Google, Microsoft and Twitter have all objected to portions of a federal effort to strengthen online privacy protections for children. In addition, media giants like Viacom and Disney, cable operators, marketing associations, technology groups and a trade group representing toy makers are arguing that the Federal Trade Commission’s proposed rule changes seem so onerous that, rather than enhance online protections for children, they threaten to deter companies from offering children’s Web sites and services altogether.

“If adopted, the effect of these new rules would be to slow the deployment of applications that provide tremendous benefits to children, and to slow the economic growth and job creation generated by the app economy,” Catherine A. Novelli, vice president of worldwide government affairs at Apple, wrote in comments to the agency.

But the underlying concern, for both the industry and regulators, is not so much about online products for children themselves. It is about the data collection and data mining mechanisms that facilitate digital marketing on apps and Web sites for children — and a debate over whether these practices could put children at greater risk.

In 1998, Congress passed the Children’s Online Privacy Protection Act in an effort to give parents control over the collection and dissemination of private information about their children online. The regulation, known as Coppa, requires Web site operators to obtain a parent’s consent before collecting personal details, like home addresses or e-mail addresses, from children under 13.

Now, federal regulators are preparing to update that rule, arguing that it has not kept pace with advances like online behavioral advertising, a practice that uses data mining to tailor ads to people’s online behavior. The F.T.C. wants to expand the types of data whose collection requires prior parental permission to include persistent ID systems, like unique device codes or customer code numbers stored in cookies, if those codes are used to track children online for advertising purposes.

The idea is to preclude companies from compiling dossiers on the online activities — and by extension the health, socioeconomic status, race or romantic concerns — of individual children across the Web over time.

“What children post online or search as part of their homework should not haunt them as they apply to colleges or for jobs,” Representative Edward J. Markey, Democrat of Massachusetts and co-chairman of the Bipartisan Congressional Privacy Caucus, said in a recent phone interview. “YouTube should not be turned into YouTracked.”

The agency’s proposals have provoked an intense reaction from some major online operators, television networks, social networks, app platforms and advertising trade groups. Some argue that the F.T.C. has overstepped its mandate in proposing to greatly expand the rule’s scope.

Others say that using ID systems like customer code numbers to track children “anonymously” online is benign — and that collecting information about children’s online activities is necessary to deliver the ads that finance free content and services for children.

“What is the harm we are trying to prevent here?” said Alan L. Friel, chairman of the media and technology practice at the law firm Edwards Wildman Palmer. “We risk losing a lot of the really good educational and entertaining content if we make things too difficult for people to operate the sites or generate revenue from the sites.”

The economic issue at stake is much bigger than just the narrow children’s audience. If the F.T.C. were to include customer code numbers among the information that requires a parent’s consent, industry analysts say, it might someday require companies to get similar consent for a practice that represents the backbone of digital marketing and advertising — using such code numbers to track the online activities of adults.

“Once you’ve said it’s personal information for children that requires consent, you’ve set the framework for a requirement of consent to be applied to another population,” Mr. Friel said. “If it is personal information for someone that’s 12, it doesn’t cease being personal information when they are 13.”

Indeed, many of the F.T.C.’s proposed rule revisions have vocal detractors.

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Egyptian Vigilantes Crack Down on Abuse of Women

Tara Todras-Whitehill for The New York Times

A self-appointed citizens patrol that tries to protect women on Cairo’s streets spray-painted a youth for identification last month.

CAIRO — The young activists lingered on the streets around Tahrir Square, scrutinizing the crowds of holiday revelers. Suddenly, they charged, pushing people aside and chasing down a young man. As the captive thrashed to get away, the activists pounded his shoulders, flipped him around and spray-painted a message on his back: “I’m a harasser.”

Egypt’s streets have long been a perilous place for women, who are frequently heckled, grabbed, threatened and violated while the police look the other way. Now, during the country’s tumultuous transition from authoritarian rule, more and more groups are emerging to make protecting women — and shaming the do-nothing police — a cause.

“They’re now doing the undoable?” a police officer joked as he watched the vigilantes chase down the young man. The officer quickly went back to sipping his tea.

The attacks on women did not subside after the uprising. If anything, they became more visible as even the military was implicated in the assaults, stripping female protesters, threatening others with violence and subjecting activists to so-called virginity tests. During holidays, when Cairenes take to the streets to stroll and socialize, the attacks multiply.

But during the recent Id al-Adha holiday, some of the men were surprised to find they could no longer harass with impunity, a change brought about not just out of concern for women’s rights, but out of a frustration that the post-revolutionary government still, like the one before, was doing too little to protect its citizens.

At least three citizens groups patrolled busy sections of central Cairo during the holiday. The groups’ members, both men and women, shared the conviction that the authorities would not act against harassment unless the problem was forced into the public debate. They differed in their tactics: some activists criticized others for being too quick to resort to violence against suspects and encouraging vigilantism.  One group leader compared the activists to the Guardian Angels in the United States.

“The harasser doesn’t see anyone who will hold him accountable,” said Omar Talaat, 16, who joined one of the patrols.

The years of President Hosni Mubarak’s rule were marked by official apathy, collusion in the assaults on women, or empty responses to the attacks, including police roundups of teenagers at Internet cafes for looking at pornography.

“The police did not take harassment seriously,” said Madiha el-Safty, a sociology professor at the American University in Cairo. “People didn’t file complaints. It was always underreported.”

Mr. Mubarak’s wife, Suzanne, who portrayed herself as a champion of women’s rights, pretended the problem hardly existed. As reports of harassment grew in 2008, she said, “Egyptian men always respect Egyptian women.”

Egypt’s new president, Mohamed Morsi, has presided over two holidays, and many activists say there is no sign that the government is paying closer attention to the problem. But the work by the citizens groups may be having an effect: Last week, after the Id al-Adha holiday, Mr. Morsi’s spokesman announced that the government had received more than 1,000 reports of harassment, and said that the president had directed the Interior Ministry to investigate them.

“Egypt’s revolution cannot tolerate these abuses,” the spokesman quoted Mr. Morsi as saying.

Azza Soliman, the director of the Center for Egyptian Women’s Legal Assistance, dismissed the president’s words as “weak.” During the holiday, she said, one of her sons was beaten on the subway after he tried to stop a man who was groping two foreign women. The police tried to stop him from filing a complaint. “The whole world is talking about harassment in our country,” Ms. Soliman said. “The Interior Ministry takes no action.”

For years, anti-harassment activists have worked to highlight the problems in Egypt, but the uprising seemed to give the effort more energy and urgency.

Asmaa Al Zohairy contributed reporting.

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