Tentative Accord Reached to Raise Taxes on Wealthy

Drew Angerer/Getty Images

Vice President Joseph R. Biden Jr. arrived for a closed-door meeting with Senate Democrats on Monday evening.

WASHINGTON — Furious last-minute negotiations between the White House and the Senate Republican leadership on Monday secured a tentative agreement to allow tax rates to rise on affluent Americans, but the measure was not going to pass in time for Congress to meet its Dec. 31 deadline for averting automatic tax increases and spending cuts deemed a threat to the economy.

While the Senate moved toward a vote on legislation to avoid the so-called fiscal cliff, the House was not going to consider any deal until Tuesday afternoon at the earliest, meaning that a combination of tax increases and spending cuts would go into effect as 2013 began. If Congress acts quickly and sends the legislation to President Obama, the economic impact could still be very limited.

Under the agreement, tax rates would jump to 39.6 percent from 35 percent for individual incomes over $400,000 and couples over $450,000, while tax deductions and credits would start phasing out on incomes as low as $250,000, a clear win for President Obama, who campaigned on higher taxes for the wealthy.

“Just last month Republicans in Congress said they would never agree to raise tax rates on the wealthiest Americans,” Mr. Obama said at a hastily arranged news briefing, with middle-income onlookers cheering behind him. “Obviously, the agreement that’s currently being discussed would raise those rates and raise them permanently.”

Democrats also secured a full year’s extension of unemployment insurance without strings attached and without offsetting spending cuts, a $30 billion cost.

As negotiators tied up the last points of dispute, officials said that the two top Democrats on Capitol Hill — Senator Harry Reid of Nevada and Representative Nancy Pelosi of California — had signed off on the agreement. In an effort to win over other Democrats uneasy with the proposal, Vice President Joseph R. Biden Jr., who had bargained directly with Republican leaders, traveled to the Capitol on Monday night for a 90-minute meeting with his former Senate colleagues.

In one final piece of the puzzle, negotiators agreed to put off $110 billion in across-the-board cuts to military and domestic programs for two months while broader deficit reduction talks continue. Those cuts begin to go into force on Wednesday, and that deadline, too, might be missed before Congress approves the legislation.

The nature of the deal ensured that the running war between the White House and Congressional Republicans on spending and taxes will continue at least until the spring. Treasury Secretary Timothy F. Geithner formally notified Congress that the government reached its statutory borrowing limit on New Year’s Eve. Through some creative accounting tricks, the Treasury Department can put off action for perhaps two months, but Congress must act to keep the government from defaulting just when the “pause” on pending cuts is up. Then in late March, a temporary law financing the government expires.

And the new deal does nothing to address the big issues that Mr. Obama and Speaker John A. Boehner hoped to deal with in their failed “grand bargain” talks two weeks ago: booming entitlement spending and a tax code so complex that few defend it anymore.

Though the tentative deal had a chance of success if put to a vote, it landed with a thud on Capitol Hill. Republicans accused the White House of “moving the goal posts” by demanding still more tax increases to help shut off across-the-board spending cuts beyond the two-month pause. Democrats were incredulous that the president had ultimately agreed to around $600 billion in new tax revenue over 10 years when even Mr. Boehner had promised $800 billion. But the White House said it had also won concessions on unemployment insurance and the inheritance tax among other wins.

Still, Democrats openly worried that if Mr. Obama could not drive a harder bargain when he holds most of the cards, he will give up still more Democratic priorities in the coming weeks, when hard deadlines will raise the prospects of a government default first, then a government shutdown. In both instances, conservative Republicans are more willing to breach the deadlines than in this case, when conservatives cringed at the prospects of huge tax increases.

“I just don’t think Obama’s negotiated very well,” said Senator Tom Harkin, Democrat of Iowa.

Jennifer Steinhauer and Robert Pear contributed reporting.

Read More..

Letters: Recovery After Trauma

To the Editor:

Re “A New Focus on the ‘Post’ in Post-Traumatic Stress” (Mind, Dec. 25): Social contexts are well-established predictors of adjustment following trauma. Sexual abuse survivors who are believed and supported following an abuse disclosure fare better than those who are not, and returning veterans’ social support predicts P.T.S.D. over and above the extent of military trauma exposure. Interpersonal traumas cause greater psychological scars than do noninterpersonal traumas like accidents or disasters, with the worst outcomes linked to trauma perpetrated by someone to whom the victim was close.

Rachel Goldsmith

New York

The writer is a clinical psychologist.

Read More..

Letters: Recovery After Trauma

To the Editor:

Re “A New Focus on the ‘Post’ in Post-Traumatic Stress” (Mind, Dec. 25): Social contexts are well-established predictors of adjustment following trauma. Sexual abuse survivors who are believed and supported following an abuse disclosure fare better than those who are not, and returning veterans’ social support predicts P.T.S.D. over and above the extent of military trauma exposure. Interpersonal traumas cause greater psychological scars than do noninterpersonal traumas like accidents or disasters, with the worst outcomes linked to trauma perpetrated by someone to whom the victim was close.

Rachel Goldsmith

New York

The writer is a clinical psychologist.

Read More..

Antivirus Makers Work on Software to Catch Malware More Effectively

Rina Castelnuovo for The New York Times

Amichai Shulman, the chief technology officer at Imperva. The data security firm recently found that antivirus software programs perform poorly against new viruses.

SAN FRANCISCO — The antivirus industry has a dirty little secret: its products are often not very good at stopping viruses.

Symantec

Security experts at the Symantec Security Operation Center in Alexandria, Va. The word “antivirus” is less used on its products.

Consumers and businesses spend billions of dollars every year on antivirus software. But these programs rarely, if ever, block freshly minted computer viruses, experts say, because the virus creators move too quickly. That is prompting start-ups and other companies to get creative about new approaches to computer security.

“The bad guys are always trying to be a step ahead,” said Matthew D. Howard, a venture capitalist at Norwest Venture Partners who previously set up the security strategy at Cisco Systems. “And it doesn’t take a lot to be a step ahead.”

Computer viruses used to be the domain of digital mischief makers. But in the mid-2000s, when criminals discovered that malicious software could be profitable, the number of new viruses began to grow exponentially.

In 2000, there were fewer than a million new strains of malware, most of them the work of amateurs. By 2010, there were 49 million new strains, according to AV-Test, a German research institute that tests antivirus products.

The antivirus industry has grown as well, but experts say it is falling behind. By the time its products are able to block new viruses, it is often too late. The bad guys have already had their fun, siphoning out a company’s trade secrets, erasing data or emptying a consumer’s bank account.

A new study by Imperva, a data security firm in Redwood City, Calif., and students from the Technion-Israel Institute of Technology is the latest confirmation of this. Amichai Shulman, Imperva’s chief technology officer, and a group of researchers collected and analyzed 82 new computer viruses and put them up against more than 40 antivirus products, made by top companies like Microsoft, Symantec, McAfee and Kaspersky Lab. They found that the initial detection rate was less than 5 percent.

On average, it took almost a month for antivirus products to update their detection mechanisms and spot the new viruses. And two of the products with the best detection rates — Avast and Emsisoft — are available free; users are encouraged to pay for additional features. This despite the fact that consumers and businesses spent a combined $7.4 billion on antivirus software last year — nearly half of the $17.7 billion spent on security software in 2011, according to Gartner.

“Existing methodologies we’ve been protecting ourselves with have lost their efficacy,” said Ted Schlein, a security-focused investment partner at Kleiner Perkins Caufield & Byers. “This study is just another indicator of that. But the whole concept of detecting what is bad is a broken concept.”

Part of the problem is that antivirus products are inherently reactive. Just as medical researchers have to study a virus before they can create a vaccine, antivirus makers must capture a computer virus, take it apart and identify its “signature” — unique signs in its code — before they can write a program that removes it.

That process can take as little as a few hours or as long as several years. In May, researchers at Kaspersky Lab discovered Flame, a complex piece of malware that had been stealing data from computers for an estimated five years.

Mikko H. Hypponen, chief researcher at F-Secure, called Flame “a spectacular failure” for the antivirus industry. “We really should have been able to do better,” he wrote in an essay for Wired.com after Flame’s discovery. “But we didn’t. We were out of our league in our own game.”

Symantec and McAfee, which built their businesses on antivirus products, have begun to acknowledge their limitations and to try new approaches. The word “antivirus” does not appear once on their home pages. Symantec rebranded its popular antivirus packages: its consumer product is now called Norton Internet Security, and its corporate offering is now Symantec Endpoint Protection.

“Nobody is saying antivirus is enough,” said Kevin Haley, Symantec’s director of security response. Mr. Haley said Symantec’s antivirus products included a handful of new technologies, like behavior-based blocking, which looks at some 30 characteristics of a file, including when it was created and where else it has been installed, before allowing it to run. “In over two-thirds of cases, malware is detected by one of these other technologies,” he said.

Read More..

Ruthless Smuggling Rings Put Rhinos in Cross Hairs

KRUGER NATIONAL PARK, South Africa — They definitely did not look like ordinary big-game hunters, the stream of slender young Thai women who showed up on the veld wearing tight bluejeans and sneakers.

But the rhinoceros carcasses kept piling up around them, and it was only after dozens of these hulking, relatively rare animals were dead and their precious horns sawed off that an extravagant scheme came to light.

The Thai women, it ends up, were not hunters at all. Many never even squeezed off a shot. Instead, they were prostitutes hired by a criminal syndicate based 6,000 miles away in Laos to exploit loopholes in big-game hunting rules and get its hands on as many rhino horns as possible — horns that are now worth more than gold.

“These girls had no idea what they were doing,” said Paul O’Sullivan, a private investigator in Johannesburg who helped crack the case. “They thought they were going on safari.”

The rhino horn rush has gotten so out of control that it has exploded into a worldwide criminal enterprise, drawing in a surreal cast of characters — not just Thai prostitutes, but also Irish gangsters, Vietnamese diplomats, Chinese scientists, veterinarians, copter pilots, antiques dealers and recently an American rodeo star looking for a quick buck who used Facebook to find some horns.

Driven by a common belief in Asia that ground-up rhino horns can cure cancer and other ills, the trade has also been embraced by criminal syndicates that normally traffic drugs and guns, but have branched into the underground animal parts business because it is seen as “low risk, high profit,” American officials say.

“Get caught smuggling a kilo of cocaine, you will receive a very significant prison sentence,” said Ed Grace, a deputy chief with the United States Fish and Wildlife Service. But with a kilogram of rhino horn, he added, “you may only get a fine.”

The typical rhino horn is about two feet long and 10 pounds, much of it formed from the same substance as fingernails. Yet it can fetch nearly $30,000 a pound, more than crack cocaine, and conservationists worry that this “ridiculous price,” as one wildlife manager put it, could drive rhinos into extinction.

Gangs are so desperate for new sources of horn that criminals have even smashed into dozens of glass museum cases all across Europe to snatch them from exhibits.

“Astonishment and rage, that’s what we felt,” said Paolo Agnelli, a manager at the Florence Museum of Natural History, after three rhino horns were stolen last year, including a very rare one from 1824.

American federal agents recently staged a cross-country undercover rhino horn sting operation, called Operation Crash, “crash” being the term for a herd of rhinos.

Among the 12 people arrested: Wade Steffen, a champion steer wrestler from Texas, who pleaded guilty in May to trafficking dozens of horns that he found through hunters, estate sales and Facebook; and two members of an Irish gang — the same gang suspected of breaking into the museums in Europe.

In an e-mail to an undercover agent, an Irish gangster bragged: “Believe me WE NEVER LOSES A HORN TO CUSTOMS, we have so many contacts and people payed off now we can bring anything we want out of nearly any country into Europe.”

Corruption is a huge element, just like in the illegal ivory trade, in which rebel groups, government armies and threadbare hunters have been wiping out tens of thousands of elephants throughout Africa, selling the tusks to sophisticated criminal networks that move them across the globe with the help of corrupt officials.

Here in South Africa, home to the majority of the world’s last surviving 28,000 rhinos or so, the country is throwing just about everything it has to stop the slaughter — thousands of rangers, the national army, a new spy plane, even drones — but it is losing.

The number of rhinos poached in South Africa has soared in the past five years, from 13 killed in 2007 to more than 630 in 2012. The prehistoric, battleship-gray animals are often found on their knees, bleeding to death from a gaping stump on their face.

Gaia Pianigiani contributed reporting from Rome.

Read More..

Chinese Firm Is Cleared to Buy American DNA Sequencing Company

Ramin Rahimian for The New York Times

DNA sequencing machines at Complete Genomics in California. The firm dismissed concerns about its acquisition.

The federal government has given national security clearance to the controversial purchase of an American DNA sequencing company by a Chinese firm.

The Chinese firm, BGI-Shenzhen, said in a statement this weekend that its acquisition of Complete Genomics, based in Mountain View, Calif., had been cleared by the federal Committee on Foreign Investment in the United States, which reviews the national security implications of foreign takeovers of American companies. The deal still requires antitrust clearance by the Federal Trade Commission.

Some scientists, politicians and industry executives had said the takeover represented a threat to American competitiveness in DNA sequencing, a technology that is becoming crucial for the development of drugs, diagnostics and improved crops.

The fact that the $117.6 million deal was controversial at all reflects a change in the genomics community.

A decade ago, the Human Genome Project, in which scientists from many nations helped unravel the genetic blueprint of mankind, was celebrated for its spirit of international cooperation. One of the participants in the project was BGI, which was then known as the Beijing Genomics Institute.

But with DNA sequencing now becoming a big business and linchpin of the biotechnology industry, international rivalries and nationalism are starting to move front and center in any acquisition.

Much of the alarm about the deal has been raised by Illumina, a San Diego company that is the market leader in sequencing machines. It has potentially the most to lose from the deal because BGI might buy fewer Illumina products and even become a competitor. Weeks after the BGI deal was announced, Illumina made its own belated bid for Complete Genomics, offering 15 cents a share more than BGI’s bid of $3.15. But Complete Genomics rebuffed Illumina, saying such a merger would never clear antitrust review.

Illumina also hired a Washington lobbyist, the Glover Park Group, to stir up opposition to the deal in Congress. Representative Frank R. Wolf, Republican of Virginia, was the only member of Congress known to have publicly expressed concern.

BGI and Complete Genomics point out that Illumina has long sold its sequencing machines — including a record-setting order of 128 high-end machines — to BGI without raising any security concerns. Sequencing machines have not been subject to export controls like aerospace equipment, lasers, sensors and other gear that can have clear military uses.

“Illumina has never previously considered its business with BGI as ‘sensitive’ in the least,” Ye Yin, the chief operating officer of BGI, said in a November letter to Complete Genomics that was made public in a regulatory filing. In the letter, Illumina was accused of “obvious hypocrisy.”

BGI and Complete said that Illumina was trying to derail the agreement and acquire Complete Genomics itself in order to “eliminate its closest competitor, Complete.”

BGI is already one of the most prolific DNA sequencers in the world, but it buys the sequencing machines it uses from others, mainly Illumina.

Illumina, joined by some American scientists, said it worried that if BGI gained access to Complete’s sequencing technology, the Chinese company might use low prices to undercut the American sequencing companies that now dominate the industry.

Some also said that with Complete Genomics providing an American base, BGI would have access to more DNA samples from Americans, helping it compile a huge database of genetic information that could be used to develop drugs and diagnostic tests. Some also worried about protection of the privacy of genetic information.

“What’s to stop them from mining genomic data of American samples to some unknown nefarious end?” Elaine R. Mardis, co-director of the genome sequencing center at Washington University in St. Louis, said in an e-mail.

Dr. Mardis could not specify what kind of nefarious end she imagined. But opponents of the deal cited a November article in The Atlantic saying that in the future, pathogens could be genetically engineered to attack particular individuals, including the president, based on their DNA sequences.

BGI and Complete Genomics dismissed such concerns as preposterous.

Read More..

Chinese Firm Is Cleared to Buy American DNA Sequencing Company

Ramin Rahimian for The New York Times

DNA sequencing machines at Complete Genomics in California. The firm dismissed concerns about its acquisition.

The federal government has given national security clearance to the controversial purchase of an American DNA sequencing company by a Chinese firm.

The Chinese firm, BGI-Shenzhen, said in a statement this weekend that its acquisition of Complete Genomics, based in Mountain View, Calif., had been cleared by the federal Committee on Foreign Investment in the United States, which reviews the national security implications of foreign takeovers of American companies. The deal still requires antitrust clearance by the Federal Trade Commission.

Some scientists, politicians and industry executives had said the takeover represented a threat to American competitiveness in DNA sequencing, a technology that is becoming crucial for the development of drugs, diagnostics and improved crops.

The fact that the $117.6 million deal was controversial at all reflects a change in the genomics community.

A decade ago, the Human Genome Project, in which scientists from many nations helped unravel the genetic blueprint of mankind, was celebrated for its spirit of international cooperation. One of the participants in the project was BGI, which was then known as the Beijing Genomics Institute.

But with DNA sequencing now becoming a big business and linchpin of the biotechnology industry, international rivalries and nationalism are starting to move front and center in any acquisition.

Much of the alarm about the deal has been raised by Illumina, a San Diego company that is the market leader in sequencing machines. It has potentially the most to lose from the deal because BGI might buy fewer Illumina products and even become a competitor. Weeks after the BGI deal was announced, Illumina made its own belated bid for Complete Genomics, offering 15 cents a share more than BGI’s bid of $3.15. But Complete Genomics rebuffed Illumina, saying such a merger would never clear antitrust review.

Illumina also hired a Washington lobbyist, the Glover Park Group, to stir up opposition to the deal in Congress. Representative Frank R. Wolf, Republican of Virginia, was the only member of Congress known to have publicly expressed concern.

BGI and Complete Genomics point out that Illumina has long sold its sequencing machines — including a record-setting order of 128 high-end machines — to BGI without raising any security concerns. Sequencing machines have not been subject to export controls like aerospace equipment, lasers, sensors and other gear that can have clear military uses.

“Illumina has never previously considered its business with BGI as ‘sensitive’ in the least,” Ye Yin, the chief operating officer of BGI, said in a November letter to Complete Genomics that was made public in a regulatory filing. In the letter, Illumina was accused of “obvious hypocrisy.”

BGI and Complete said that Illumina was trying to derail the agreement and acquire Complete Genomics itself in order to “eliminate its closest competitor, Complete.”

BGI is already one of the most prolific DNA sequencers in the world, but it buys the sequencing machines it uses from others, mainly Illumina.

Illumina, joined by some American scientists, said it worried that if BGI gained access to Complete’s sequencing technology, the Chinese company might use low prices to undercut the American sequencing companies that now dominate the industry.

Some also said that with Complete Genomics providing an American base, BGI would have access to more DNA samples from Americans, helping it compile a huge database of genetic information that could be used to develop drugs and diagnostic tests. Some also worried about protection of the privacy of genetic information.

“What’s to stop them from mining genomic data of American samples to some unknown nefarious end?” Elaine R. Mardis, co-director of the genome sequencing center at Washington University in St. Louis, said in an e-mail.

Dr. Mardis could not specify what kind of nefarious end she imagined. But opponents of the deal cited a November article in The Atlantic saying that in the future, pathogens could be genetically engineered to attack particular individuals, including the president, based on their DNA sequences.

BGI and Complete Genomics dismissed such concerns as preposterous.

Read More..

Chinese Firm Is Cleared to Buy American DNA Sequencing Company

Ramin Rahimian for The New York Times

DNA sequencing machines at Complete Genomics in California. The firm dismissed concerns about its acquisition.

The federal government has given national security clearance to the controversial purchase of an American DNA sequencing company by a Chinese firm.

The Chinese firm, BGI-Shenzhen, said in a statement this weekend that its acquisition of Complete Genomics, based in Mountain View, Calif., had been cleared by the federal Committee on Foreign Investment in the United States, which reviews the national security implications of foreign takeovers of American companies. The deal still requires antitrust clearance by the Federal Trade Commission.

Some scientists, politicians and industry executives had said the takeover represented a threat to American competitiveness in DNA sequencing, a technology that is becoming crucial for the development of drugs, diagnostics and improved crops.

The fact that the $117.6 million deal was controversial at all reflects a change in the genomics community.

A decade ago, the Human Genome Project, in which scientists from many nations helped unravel the genetic blueprint of mankind, was celebrated for its spirit of international cooperation. One of the participants in the project was BGI, which was then known as the Beijing Genomics Institute.

But with DNA sequencing now becoming a big business and linchpin of the biotechnology industry, international rivalries and nationalism are starting to move front and center in any acquisition.

Much of the alarm about the deal has been raised by Illumina, a San Diego company that is the market leader in sequencing machines. It has potentially the most to lose from the deal because BGI might buy fewer Illumina products and even become a competitor. Weeks after the BGI deal was announced, Illumina made its own belated bid for Complete Genomics, offering 15 cents a share more than BGI’s bid of $3.15. But Complete Genomics rebuffed Illumina, saying such a merger would never clear antitrust review.

Illumina also hired a Washington lobbyist, the Glover Park Group, to stir up opposition to the deal in Congress. Representative Frank R. Wolf, Republican of Virginia, was the only member of Congress known to have publicly expressed concern.

BGI and Complete Genomics point out that Illumina has long sold its sequencing machines — including a record-setting order of 128 high-end machines — to BGI without raising any security concerns. Sequencing machines have not been subject to export controls like aerospace equipment, lasers, sensors and other gear that can have clear military uses.

“Illumina has never previously considered its business with BGI as ‘sensitive’ in the least,” Ye Yin, the chief operating officer of BGI, said in a November letter to Complete Genomics that was made public in a regulatory filing. In the letter, Illumina was accused of “obvious hypocrisy.”

BGI and Complete said that Illumina was trying to derail the agreement and acquire Complete Genomics itself in order to “eliminate its closest competitor, Complete.”

BGI is already one of the most prolific DNA sequencers in the world, but it buys the sequencing machines it uses from others, mainly Illumina.

Illumina, joined by some American scientists, said it worried that if BGI gained access to Complete’s sequencing technology, the Chinese company might use low prices to undercut the American sequencing companies that now dominate the industry.

Some also said that with Complete Genomics providing an American base, BGI would have access to more DNA samples from Americans, helping it compile a huge database of genetic information that could be used to develop drugs and diagnostic tests. Some also worried about protection of the privacy of genetic information.

“What’s to stop them from mining genomic data of American samples to some unknown nefarious end?” Elaine R. Mardis, co-director of the genome sequencing center at Washington University in St. Louis, said in an e-mail.

Dr. Mardis could not specify what kind of nefarious end she imagined. But opponents of the deal cited a November article in The Atlantic saying that in the future, pathogens could be genetically engineered to attack particular individuals, including the president, based on their DNA sequences.

BGI and Complete Genomics dismissed such concerns as preposterous.

Read More..

Questcor Finds Profit for Acthar Drug, at $28,000 a Vial

Kevin Moloney for The New York Times

Christina Culver with her son Tyler, 6, at home in Colorado Springs this month. In 2007, Tyler was hospitalized when the price of Acthar soared.

THE doctor was dumbfounded: a drug that used to cost $50 was now selling for $28,000 for a 5-milliliter vial.

The physician, Dr. Ladislas Lazaro IV, remembered occasionally prescribing this anti-inflammatory, named H.P. Acthar Gel, for gout back in the early 1990s. Then the drug seemed to fade from view. Dr. Lazaro had all but forgotten about it, until a sales representative from a company called Questcor Pharmaceuticals appeared at his office and suggested that he try it for various rheumatologic conditions.

“I’ve never seen anything like this,” Dr. Lazaro, a rheumatologist in Lafayette, La., says of the price increase.

How the price of this drug rose so far, so fast is a story for these troubled times in American health care — a tale of aggressive marketing, questionable medicine and, not least, out-of-control costs. At the center of it is Questcor, which turned the once-obscure Acthar into a hugely profitable wonder drug and itself into one of Wall Street’s highest fliers.

At least until recently, that is. Now some doctors, insurance companies and investors are beginning to have doubts about whether the drug is really any better than much cheaper alternatives. Short-sellers have written scathing criticisms of the company, questioning its marketing tactics and predicting that its shareholders are highly vulnerable.

 That Acthar is even a potential blockbuster is a remarkable turn of events, considering that the drug was developed in the 1950s by a division of Armour & Company, the meatpacking company that once ruled the Union Stock Yards of Chicago. As in the 1950s, Acthar is still extracted from the pituitary glands of slaughtered pigs — essentially a byproduct of the meatpacking industry.

The most important use of Acthar has been to treat infantile spasms, also known as West syndrome, a rare, sometimes fatal epileptic disorder that generally strikes before the age of 1.

For several years, Questcor, which is based in Anaheim, lost money on Acthar because the drug’s market was so small. In 2007, it raised the price overnight, to more than $23,000 a vial, from $1,650, bringing the cost of a typical course of treatment for infantile spasms to above $100,000. It said it needed the high price to keep the drug on the market.

“We have this drug at a very high price right now because, really, our principal market is infantile spasms,” Don M. Bailey, Questcor’s chief executive, told analysts in 2009. “And we only have about 800 patients a year. It’s a very, very small — tiny — market.”

Companies often charge stratospheric prices for drugs for rare diseases — known as orphan drugs — and Acthar’s price is not as high as some. Society generally tolerates those costs to encourage drug companies to develop crucial, possibly lifesaving drugs for these often neglected diseases.

But Questcor did almost no research or development to bring Acthar to market, merely buying the rights to the drug from its previous owner for $100,000 in 2001. And while the manufacturing of Acthar is complex, it accounts for only about 1 cent of every dollar that Questcor charges for the drug.

Moreover, the tiny “orphan” market soon became much bigger. Before long, Questcor began marketing the drug for multiple sclerosis, nephrotic syndrome and rheumatologic conditions, even though there is little evidence that Acthar is more effective for those other conditions than alternatives that are far cheaper. And the company did so without being required to prove that the drug actually works. That is because Acthar was approved for use in 1952, before the Food and Drug Administration required clinical trials to show a drug is effective for a particular disease. Acthar is essentially grandfathered in.

Today, only about 10 percent of the drug’s sales are for infantile spasms. The new uses, Mr. Bailey has told analysts, represent multibillion-dollar opportunities for Acthar and Questcor, its sole maker.

The results have been beyond even the company’s wildest dreams. Sales of Acthar, which accounts for essentially all of Questcor’s sales, totaled nearly $350 million in the first nine months this year, up 145 percent from the period a year earlier. In the same period, Questcor’s earnings per share nearly tripled, to $2.12. In the five years after the big Acthar price increase in August 2007, Questcor shares rose from around 60 cents to about $50, in one of the best performances of any stock in any industry.

But in September, the shares plummeted after Aetna, the big insurer, said it would no longer pay for Acthar, except to treat infantile spasms, because of lack of evidence the drug worked for other diseases. The stock now trades at $26.93.

Peter Wickersham, senior vice president for cost of care at Prime Therapeutics, a pharmacy benefits manager that has found the drug is possibly being overused, says the huge increase in Acthar’s price for patients “just invites the type of scrutiny that it’s received.”

Read More..

Cold-Weather Aid Trickles Into Afghan Camps

But camp leaders and Afghan government officials criticized the aid delivery as inadequate to protect residents from the weather and to prevent more deaths.

Last winter, more than 100 children died of the cold in refugee camps around Kabul, with 26 dying in the Charahi Qambar camp alone. That is the same camp where the 3-year-old died Friday; it was the first confirmed death because of the cold this winter.

The distribution of supplies at the camp, which is home to about 900 families in western Kabul, had been scheduled before news reports about the child’s death, said Mohammad Nader Farhad, a spokesman for the United Nations refugees agency in Kabul.

On less than an hour’s notice, the agency convened a news conference with Afghan government officials at the camp to announce the distribution.

Each family was given warm children’s clothing, blankets, tarps, cooking utensils and soap. Separately, other aid groups, financed by the United Nations and other donors, will be distributing charcoal once every month through February, officials said.

United Nations officials acknowledged, however, that the fuel distributions in themselves were not enough to heat the mud and tarp huts throughout the season, and there were no plans to distribute food to the families. In most cases the men, who are largely war-displaced refugees, are unable to find day work as laborers in the cold weather, so they are usually unable to buy food.

“We are happy to receive this,” said Tawoos Khan, one of the camp representatives. “But we want food, and we need more fuel; we have all run out of firewood and charcoal.” He and other camp officials said large sacks of charcoal were distributed to every family more than two weeks ago, but supplies had run out.

“It’s supplementary,” said Douglas DiSalvo, a protection officer with the United Nations agency who was at the Charahi Qambar camp. “People have some level of support they can achieve for themselves.”

Mr. Farhad said, “The assistance we are providing, at least it is mitigating the harsh winter these families are experiencing right now.”

The estimated 35,000 people in 50 camps in and around Kabul are not classified as refugees from an international legal point of view, but as “internally displaced persons.” Since the United Nations agency’s mandate is to primarily help refugees — defined as those who flee across international borders — it has not provided support to the Kabul camps in the past. That changed late last winter when the Afghan government asked it to do so in response to the conditions that were taking so many lives.

This year, the agency is spearheading the effort to supply the camps, along with the Afghan government’s Ministry of Refugees and Repatriation, other United Nations agencies, and several aid groups, in order to prevent a recurrence of the crisis last winter.

Ministry officials, however, criticized the effort on Sunday — even though they were among the sponsors. “We have never claimed that we provided the internally displaced Afghans with sufficient food items, clothing or means of heat. We admit this. What the internally displaced people have received so far is not adequate at all,” said Islamuddin Jurat, a spokesman for the Ministry of Refugees and Repatriation.

“Before the arrival of harsh winter,” he added, “we asked the international community and donor countries to help the internally displaced people, and luckily today U.N.H.C.R. provided them with some humanitarian assistance. But again we believe it’s not sufficient at all.”

Both aid officials and the Afghan government have said they are wary about providing too much aid for fear that it would encourage more people to leave their homes. That fear has also been why the Afghan government has refused to allow permanent buildings to be erected in the camps, many of which are five or more years old.

“The illegal nature of these squatter settlements poses an obstacle to more lasting interventions and improvements,” said Mr. Farhad of the United Nations refugees agency. “Coordination this year has been very strong, and we expect that the multiagency effort will help us to detect and respond to particular problem areas as the winter progresses.”

Little is provided in the way of food aid. The only food aid in the Charahi Qambar camp is a hot lunch program for 750 students at a tented school run by Aschiana, an Afghan aid group.

The United Nations High Commissioner for Refugees is providing the cold-weather packages to 40,000 families, 5,000 of them in the Kabul camps, at a cost of $6 million. Other Kabul camps will receive distributions in the next two days, Mr. Farhad said.

The packages, which cost about $150 each, include two tarps, three blankets, six bars of soap, a cooking utensils set, and 26 items of clothing ranging from jackets and sweaters to socks and hats, mostly for children.

Taj Mohammad, the father of the child who died, Janan, said Sunday that he believed that his son might have survived if the cold-weather kit had arrived earlier. But like many of the refugees, he was critical of its contents, which he said were hard to sell in exchange for food.

“I didn’t know a package costs $150,” he said. “It’s a lot of money. It would have been much better if they had given us the money, and we would have spent it on what we need the most.”

Read More..