Genetic Gamble : Drugs Aim to Make Several Types of Cancer Self-Destruct

C.J. Gunther for The New York Times

Dr. Donald Bergstrom is a cancer specialist at Sanofi, one of three companies working on a drug to restore a tendency of damaged cells to self-destruct.

For the first time ever, three pharmaceutical companies are poised to test whether new drugs can work against a wide range of cancers independently of where they originated — breast, prostate, liver, lung. The drugs go after an aberration involving a cancer gene fundamental to tumor growth. Many scientists see this as the beginning of a new genetic age in cancer research.

Great uncertainties remain, but such drugs could mean new treatments for rare, neglected cancers, as well as common ones. Merck, Roche and Sanofi are racing to develop their own versions of a drug they hope will restore a mechanism that normally makes badly damaged cells self-destruct and could potentially be used against half of all cancers.

No pharmaceutical company has ever conducted a major clinical trial of a drug in patients who have many different kinds of cancer, researchers and federal regulators say. “This is a taste of the future in cancer drug development,” said Dr. Otis Webb Brawley, the chief medical and scientific officer of the American Cancer Society. “I expect the organ from which the cancer came from will be less important in the future and the molecular target more important,” he added.

And this has major implications for cancer philanthropy, experts say. Advocacy groups should shift from fund-raising for particular cancers to pushing for research aimed at many kinds of cancer at once, Dr. Brawley said. John Walter, the chief executive officer of the Leukemia and Lymphoma Society, concurred, saying that by pooling forces “our strength can be leveraged.”

At the heart of this search for new cancer drugs are patients like Joe Bellino, who was a post office clerk until his cancer made him too sick to work. Seven years ago, he went into the hospital for hernia surgery, only to learn he had liposarcoma, a rare cancer of fat cells. A large tumor was wrapped around a cord that connects the testicle to the abdomen. “I was shocked,” he said in an interview this summer.

Companies have long ignored liposarcoma, seeing no market for drugs to treat a cancer that strikes so few. But it is ideal for testing Sanofi’s drug because the tumors nearly always have the exact genetic problem the drug was meant to attack — a fusion of two large proteins. If the drug works, it should bring these raging cancers to a halt. Then Sanofi would test the drug on a broad range of cancers with a similar genetic alteration. But if the drug fails against liposarcoma, Sanofi will reluctantly admit defeat.

“For us, this is a go/no-go situation,” said Laurent Debussche, a Sanofi scientist who leads the company’s research on the drug.

The genetic alteration the drug targets has tantalized researchers for decades. Normal healthy cells have a mechanism that tells them to die if their DNA is too badly damaged to repair. Cancer cells have grotesquely damaged DNA, so ordinarily they would self-destruct. A protein known as p53 that Dr. Gary Gilliland of Merck calls the cell’s angel of death normally sets things in motion. But cancer cells disable p53, either directly, with a mutation, or indirectly, by attaching the p53 protein to another cellular protein that blocks it. The dream of cancer researchers has long been to reanimate p53 in cancer cells so they will die on their own.

The p53 story began in earnest about 20 years ago. Excitement ran so high that, in 1993, Science magazine anointed it Molecule of the Year and put it on the cover. An editorial held out the possibility of “a cure of a terrible killer in the not too distant future.”

Companies began chasing a drug to restore p53 in cells where it was disabled by mutations. But while scientists know how to block genes, they have not figured out how to add or restore them. Researchers tried gene therapy, adding good copies of the p53 gene to cancer cells. That did not work.

Then, instead of going after mutated p53 genes, they went after half of cancers that used the alternative route to disable p53, blocking it by attaching it to a protein known as MDM2. When the two proteins stick together, the p53 protein no longer functions. Maybe, researchers thought, they could find a molecule to wedge itself between the two proteins and pry them apart.

The problem was that both proteins are huge and cling tightly to each other. Drug molecules are typically tiny. How could they find one that could separate these two bruisers, like a referee at a boxing match?

In 1996, researchers at Roche noticed a small pocket between the behemoths where a tiny molecule might slip in and pry them apart. It took six years, but Roche found such a molecule and named it Nutlin because the lab was in Nutley, N.J.

But Nutlins did not work as drugs because they were not absorbed into the body.

Roche, Merck and Sanofi persevered, testing thousands of molecules.

At Sanofi, the stubborn scientist leading the way, Dr. Debussche, maintained an obsession with p53 for two decades. Finally, in 2009, his team, together with Shaomeng Wang at the University of Michigan and a biotech company, Ascenta Therapeutics, found a promising compound.

The company tested the drug by pumping it each day into the stomachs of mice with sarcoma.

Read More..

Genetic Gamble : Drugs Aim to Make Several Types of Cancer Self-Destruct

C.J. Gunther for The New York Times

Dr. Donald Bergstrom is a cancer specialist at Sanofi, one of three companies working on a drug to restore a tendency of damaged cells to self-destruct.

For the first time ever, three pharmaceutical companies are poised to test whether new drugs can work against a wide range of cancers independently of where they originated — breast, prostate, liver, lung. The drugs go after an aberration involving a cancer gene fundamental to tumor growth. Many scientists see this as the beginning of a new genetic age in cancer research.

Great uncertainties remain, but such drugs could mean new treatments for rare, neglected cancers, as well as common ones. Merck, Roche and Sanofi are racing to develop their own versions of a drug they hope will restore a mechanism that normally makes badly damaged cells self-destruct and could potentially be used against half of all cancers.

No pharmaceutical company has ever conducted a major clinical trial of a drug in patients who have many different kinds of cancer, researchers and federal regulators say. “This is a taste of the future in cancer drug development,” said Dr. Otis Webb Brawley, the chief medical and scientific officer of the American Cancer Society. “I expect the organ from which the cancer came from will be less important in the future and the molecular target more important,” he added.

And this has major implications for cancer philanthropy, experts say. Advocacy groups should shift from fund-raising for particular cancers to pushing for research aimed at many kinds of cancer at once, Dr. Brawley said. John Walter, the chief executive officer of the Leukemia and Lymphoma Society, concurred, saying that by pooling forces “our strength can be leveraged.”

At the heart of this search for new cancer drugs are patients like Joe Bellino, who was a post office clerk until his cancer made him too sick to work. Seven years ago, he went into the hospital for hernia surgery, only to learn he had liposarcoma, a rare cancer of fat cells. A large tumor was wrapped around a cord that connects the testicle to the abdomen. “I was shocked,” he said in an interview this summer.

Companies have long ignored liposarcoma, seeing no market for drugs to treat a cancer that strikes so few. But it is ideal for testing Sanofi’s drug because the tumors nearly always have the exact genetic problem the drug was meant to attack — a fusion of two large proteins. If the drug works, it should bring these raging cancers to a halt. Then Sanofi would test the drug on a broad range of cancers with a similar genetic alteration. But if the drug fails against liposarcoma, Sanofi will reluctantly admit defeat.

“For us, this is a go/no-go situation,” said Laurent Debussche, a Sanofi scientist who leads the company’s research on the drug.

The genetic alteration the drug targets has tantalized researchers for decades. Normal healthy cells have a mechanism that tells them to die if their DNA is too badly damaged to repair. Cancer cells have grotesquely damaged DNA, so ordinarily they would self-destruct. A protein known as p53 that Dr. Gary Gilliland of Merck calls the cell’s angel of death normally sets things in motion. But cancer cells disable p53, either directly, with a mutation, or indirectly, by attaching the p53 protein to another cellular protein that blocks it. The dream of cancer researchers has long been to reanimate p53 in cancer cells so they will die on their own.

The p53 story began in earnest about 20 years ago. Excitement ran so high that, in 1993, Science magazine anointed it Molecule of the Year and put it on the cover. An editorial held out the possibility of “a cure of a terrible killer in the not too distant future.”

Companies began chasing a drug to restore p53 in cells where it was disabled by mutations. But while scientists know how to block genes, they have not figured out how to add or restore them. Researchers tried gene therapy, adding good copies of the p53 gene to cancer cells. That did not work.

Then, instead of going after mutated p53 genes, they went after half of cancers that used the alternative route to disable p53, blocking it by attaching it to a protein known as MDM2. When the two proteins stick together, the p53 protein no longer functions. Maybe, researchers thought, they could find a molecule to wedge itself between the two proteins and pry them apart.

The problem was that both proteins are huge and cling tightly to each other. Drug molecules are typically tiny. How could they find one that could separate these two bruisers, like a referee at a boxing match?

In 1996, researchers at Roche noticed a small pocket between the behemoths where a tiny molecule might slip in and pry them apart. It took six years, but Roche found such a molecule and named it Nutlin because the lab was in Nutley, N.J.

But Nutlins did not work as drugs because they were not absorbed into the body.

Roche, Merck and Sanofi persevered, testing thousands of molecules.

At Sanofi, the stubborn scientist leading the way, Dr. Debussche, maintained an obsession with p53 for two decades. Finally, in 2009, his team, together with Shaomeng Wang at the University of Michigan and a biotech company, Ascenta Therapeutics, found a promising compound.

The company tested the drug by pumping it each day into the stomachs of mice with sarcoma.

Read More..

Amazon Book Reviews Deleted in a Purge Aimed at Manipulation

Giving raves to family members is no longer acceptable. Neither is writers’ reviewing other writers. But showering five stars on a book you admittedly have not read is fine.

After several well-publicized cases involving writers buying or manipulating their reviews, Amazon is cracking down. Writers say thousands of reviews have been deleted from the shopping site in recent months.

Amazon has not said how many reviews it has killed, nor has it offered any public explanation. So its sweeping but hazy purge has generated an uproar about what it means to review in an era when everyone is an author and everyone is a reviewer.

Is a review merely a gesture of enthusiasm or should it be held to a higher standard? Should writers be allowed to pass judgment on peers the way they have always done offline or are they competitors whose reviews should be banned? Does a groundswell of raves for a new book mean anything if the author is soliciting the comments?

In a debate percolating on blogs and on Amazon itself, quite a few writers take a permissive view on these issues.

The mystery novelist J. A. Konrath, for example, does not see anything wrong with an author indulging in chicanery. “Customer buys book because of fake review = zero harm,” he wrote on his blog.

Some readers differ. An ad hoc group of purists has formed on Amazon to track its most prominent reviewer, Harriet Klausner, who has over 25,000 reviews. They do not see how she can read so much so fast or why her reviews are overwhelmingly — and, they say, misleadingly — exaltations.

“Everyone in this group will tell you that we’ve all been duped into buying books based on her reviews,” said Margie Brown, a retired city clerk from Arizona.

Once a populist gimmick, the reviews are vital to making sure a new product is not lost in the digital wilderness. Amazon has refined the reviewing process over the years, giving customers the opportunity to rate reviews and comment on them. It is layer after layer of possible criticism.

“A not-insubstantial chunk of their infrastructure is based on their reviews — and all of that depends on having reviews customers can trust,” said Edward W. Robertson, a science fiction novelist who has watched the debate closely.

Nowhere are reviews more crucial than with books, an industry in which Amazon captures nearly a third of every dollar spent. It values reviews more than other online booksellers like Apple or Barnes & Noble, featuring them prominently and using them to help decide which books to acquire for its own imprints by its relatively new publishing arm.

So writers have naturally been vying to get more, and better, notices. Several mystery writers, including R. J. Ellory, Stephen Leather and John Locke, have recently confessed to various forms of manipulation under the general category of “sock puppets,” or online identities used to deceive. That resulted in a widely circulated petition by a loose coalition of writers under the banner, “No Sock Puppets Here Please,” asking people to “vote for book reviews you can trust.”

In explaining its purge of reviews, Amazon has told some writers that “we do not allow reviews on behalf of a person or company with a financial interest in the product or a directly competing product. This includes authors.” But writers say that rule is not applied consistently.

In some cases, the ax fell on those with a direct relationship with the author.

“My sister’s and best friend’s reviews were removed from my books,” the author M. E. Franco said in a blog comment. “They happen to be two of my biggest fans.” Another writer, Valerie X. Armstrong, said her son’s five-star review of her book, “The Survival of the Fattest,” was removed. He immediately tried to put it back “and it wouldn’t take,” she wrote.

In other cases, though, the relationship was more tenuous. Michelle Gagnon lost three reviews on her young adult novel “Don’t Turn Around.” She said she did not know two of the reviewers, while the third was a longtime fan of her work. “How does Amazon know we know each other?” she said. “That’s where I started to get creeped out.”

Mr. Robertson suggested that Amazon applied a broad brush. “I believe they caught a lot of shady reviews, but a lot of innocent ones were erased, too,” he said. He figures the deleted reviews number in the thousands, or perhaps even 10,000.

The explosion of reviews for “The 4-Hour Chef” by Timothy Ferriss shows how the system has evolved from something spontaneous to a means of marketing and promotion. On Nov. 20, publication day, dozens of highly favorable reviews immediately sprouted. Other reviewers quickly criticized Mr. Ferriss, accusing him of buying supporters.

He laughed off those suggestions. “Not only would I never do that — it’s unethical — I simply don’t have to,” he wrote in an e-mail, saying he had sent several hundred review copies to fans and potential fans. “Does that stack the deck? Perhaps, but why send the book to someone who would hate it? That doesn’t help anyone: not the reader, nor the writer.”

As a demonstration of social media’s grip on reviewing, Mr. Ferriss used Twitter and Facebook to ask for a review. “Rallying my readers,” he called it. Within an hour, 61 had complied.

A few of his early reviews were written by people who admitted they had not read the book but were giving it five stars anyway because, well, they knew it would be terrific. “I am looking forward to reading this,” wrote a user posting under the name mhpics.

A spokesman for Amazon, which published “The 4-Hour Chef,” offered this sole comment for this article: “We do not require people to have experienced the product in order to review.”

The dispute over reviews is playing out in the discontent over Mrs. Klausner, an Amazon Hall of Fame reviewer for the last 11 years and undoubtedly one of the most prolific reviewers in literary history.

Mrs. Klausner published review No. 28,366, for “A Red Sun Also Rises” by Mark Hodder. Almost immediately, it had nine critical comments. The first accused it of being “riddled with errors in grammar, spelling and punctuation.” The rest were no more kind. The Harriet Klausner Appreciation Society had struck again.

Mrs. Klausner, a 60-year-old retired librarian who lives in Atlanta, has published an average of seven reviews a day for more than a decade. “To watch her in action is unbelievable,” said her husband, Stanley. “You see the pages turning.”

Mrs. Klausner, who says ailments keep her home and insomnia keeps her up, scoffs at her critics. “You ever read a Harlequin romance?” she said. “You can finish it in one hour. I’ve always been a speed reader.” She has a message for her naysayers: “Get a life. Read a book.”

More than 99.9 percent of Mrs. Klausner’s reviews are four or five stars. “If I can make it past the first 50 pages, that means I like it, and so I review it,” she said. But even Stanley said, “She’s soft, I won’t deny that.”

The campaign against Mrs. Klausner has pushed down her reviewer ratings, which in theory makes her less influential. But when everything is subject to review, the battle is never-ending.

Ragan Buckley, an aspiring novelist active in the campaign against Mrs. Klausner under the name “Sneaky Burrito,” is a little weary. “There are so many fake reviews that I’m often better off just walking into a physical store and picking an item off the shelf at random,” she said.

Read More..

Syrian Resort Town Is Stronghold for Alawites

TARTUS, Syria — Loyalists who support the government of President Bashar al-Assad are flocking to the Mediterranean port of Tartus, creating an overflowing boomtown far removed from the tangled, scorched rubble that now mars most Syrian cities.

The New York Times

The port city of Tartus is sheltered by a mountain range.

There are no shellings or air raids to interrupt the daily calm. Families pack the cafes lining the town’s seaside corniche, usually abandoned in December to the salty winter winds. The real estate market is brisk. A small Russian naval base provides at least the impression that salvation, if needed, is near.

Many of the new residents are members of the Alawite minority, the same Shiite Muslim sect to which Mr. Assad belongs. The latest influx is fleeing from Damascus, people who have decided that summer villas, however chilly, are preferable to the looming battle for the capital.

“Going to Tartus is like going to a different country,” said a Syrian journalist who recently met residents here. “It feels totally unaffected and safe. The attitude is, ‘We are enjoying our lives while our army is fighting overseas.’ ”

Should Damascus fall to the opposition, Tartus could become the heart of an attempt to create a different country. Some expect Mr. Assad and the security elite will try to survive the collapse by establishing a rump Alawite state along the coast, with Tartus as their new capital.

There have been various signs of preparations.

This month, the governor of Tartus Province announced that experts were studying how to develop a tiny local airfield, now used mostly by crop-dusters, into a full-fledged civilian airport “to boost transportation, business, travel and tourism,” as the official Syrian news agency, SANA, reported. The announcement coincided with the first attacks on the airport in Damascus, forcing it to close temporarily to international traffic.

More important, security forces are continuously tightening an extensive ring of checkpoints around the potential borders of an Alawite canton. The mountain heartland of the Alawites rises steeply to the east of Tartus, separating it from much of Syria. Across the mountains, the Orontes River creates a rough line separating Alawite territory from central Syria. Rebel military commanders from adjoining Hama Province said government soldiers vigorously maintain checkpoints on routes leading up into the mountains.

“If we bomb a checkpoint, it is back in place sometimes within hours,” said Basil al-Hamwi, a rebel fighter, speaking on the sidelines of a meeting of opposition military commanders in Turkey. “Once, in Hama Province, we destroyed five in one day and they were all back the next day. This area is even more important for them than Damascus.”

Mr. Hamwi and other rebel leaders said there were about 40 government checkpoints along more than 60 miles in Homs and Hama Provinces alone. Many Alawite commanders of Mr. Assad’s army have sent their families to their home villages, so they are particularly aggressive in protecting the area, said Hassan M. al-Saloom, a rebel battalion commander. They have formed committees to guard the outskirts of their villages, he said, and often negotiate local truces.

“Nobody goes inside, and they don’t come out,” he said.

There are widespread suspicions within the opposition that the military is shipping weapons into the Alawite hinterland, or has already positioned them. “The mountains and the coast make it hard to raid,” Mr. Saloom said.

Castles left by the Crusaders dot the coastal range, a testament to its strategic value.

If Mr. Assad fled to Tartus, he could seek protection from the Russian naval base here, or flee aboard a Russian vessel. Russia announced Tuesday that it was sending a small flotilla toward Tartus, possibly to evacuate its citizens who live in Syria. But Tartus residents said that the Russian families from the naval base had already left, while the officers do not leave the base, which is little more than an enclosure near the civilian port.

An employee of The New York Times reported from Tartus, and Neil MacFarquhar from Antakya, Turkey. Hania Mourtada contributed reporting from Beirut, Lebanon, and Hala Droubi from Dubai, United Arab Emirates.

Read More..

Amazon Book Reviews Deleted in a Purge Aimed at Manipulation

Giving raves to family members is no longer acceptable. Neither is writers’ reviewing other writers. But showering five stars on a book you admittedly have not read is fine.

After several well-publicized cases involving writers buying or manipulating their reviews, Amazon is cracking down. Writers say thousands of reviews have been deleted from the shopping site in recent months.

Amazon has not said how many reviews it has killed, nor has it offered any public explanation. So its sweeping but hazy purge has generated an uproar about what it means to review in an era when everyone is an author and everyone is a reviewer.

Is a review merely a gesture of enthusiasm or should it be held to a higher standard? Should writers be allowed to pass judgment on peers the way they have always done offline or are they competitors whose reviews should be banned? Does a groundswell of raves for a new book mean anything if the author is soliciting the comments?

In a debate percolating on blogs and on Amazon itself, quite a few writers take a permissive view on these issues.

The mystery novelist J. A. Konrath, for example, does not see anything wrong with an author indulging in chicanery. “Customer buys book because of fake review = zero harm,” he wrote on his blog.

Some readers differ. An ad hoc group of purists has formed on Amazon to track its most prominent reviewer, Harriet Klausner, who has over 25,000 reviews. They do not see how she can read so much so fast or why her reviews are overwhelmingly — and, they say, misleadingly — exaltations.

“Everyone in this group will tell you that we’ve all been duped into buying books based on her reviews,” said Margie Brown, a retired city clerk from Arizona.

Once a populist gimmick, the reviews are vital to making sure a new product is not lost in the digital wilderness. Amazon has refined the reviewing process over the years, giving customers the opportunity to rate reviews and comment on them. It is layer after layer of possible criticism.

“A not-insubstantial chunk of their infrastructure is based on their reviews — and all of that depends on having reviews customers can trust,” said Edward W. Robertson, a science fiction novelist who has watched the debate closely.

Nowhere are reviews more crucial than with books, an industry in which Amazon captures nearly a third of every dollar spent. It values reviews more than other online booksellers like Apple or Barnes & Noble, featuring them prominently and using them to help decide which books to acquire for its own imprints by its relatively new publishing arm.

So writers have naturally been vying to get more, and better, notices. Several mystery writers, including R. J. Ellory, Stephen Leather and John Locke, have recently confessed to various forms of manipulation under the general category of “sock puppets,” or online identities used to deceive. That resulted in a widely circulated petition by a loose coalition of writers under the banner, “No Sock Puppets Here Please,” asking people to “vote for book reviews you can trust.”

In explaining its purge of reviews, Amazon has told some writers that “we do not allow reviews on behalf of a person or company with a financial interest in the product or a directly competing product. This includes authors.” But writers say that rule is not applied consistently.

In some cases, the ax fell on those with a direct relationship with the author.

“My sister’s and best friend’s reviews were removed from my books,” the author M. E. Franco said in a blog comment. “They happen to be two of my biggest fans.” Another writer, Valerie X. Armstrong, said her son’s five-star review of her book, “The Survival of the Fattest,” was removed. He immediately tried to put it back “and it wouldn’t take,” she wrote.

In other cases, though, the relationship was more tenuous. Michelle Gagnon lost three reviews on her young adult novel “Don’t Turn Around.” She said she did not know two of the reviewers, while the third was a longtime fan of her work. “How does Amazon know we know each other?” she said. “That’s where I started to get creeped out.”

Mr. Robertson suggested that Amazon applied a broad brush. “I believe they caught a lot of shady reviews, but a lot of innocent ones were erased, too,” he said. He figures the deleted reviews number in the thousands, or perhaps even 10,000.

The explosion of reviews for “The 4-Hour Chef” by Timothy Ferriss shows how the system has evolved from something spontaneous to a means of marketing and promotion. On Nov. 20, publication day, dozens of highly favorable reviews immediately sprouted. Other reviewers quickly criticized Mr. Ferriss, accusing him of buying supporters.

He laughed off those suggestions. “Not only would I never do that — it’s unethical — I simply don’t have to,” he wrote in an e-mail, saying he had sent several hundred review copies to fans and potential fans. “Does that stack the deck? Perhaps, but why send the book to someone who would hate it? That doesn’t help anyone: not the reader, nor the writer.”

As a demonstration of social media’s grip on reviewing, Mr. Ferriss used Twitter and Facebook to ask for a review. “Rallying my readers,” he called it. Within an hour, 61 had complied.

A few of his early reviews were written by people who admitted they had not read the book but were giving it five stars anyway because, well, they knew it would be terrific. “I am looking forward to reading this,” wrote a user posting under the name mhpics.

A spokesman for Amazon, which published “The 4-Hour Chef,” offered this sole comment for this article: “We do not require people to have experienced the product in order to review.”

The dispute over reviews is playing out in the discontent over Mrs. Klausner, an Amazon Hall of Fame reviewer for the last 11 years and undoubtedly one of the most prolific reviewers in literary history.

Mrs. Klausner published review No. 28,366, for “A Red Sun Also Rises” by Mark Hodder. Almost immediately, it had nine critical comments. The first accused it of being “riddled with errors in grammar, spelling and punctuation.” The rest were no more kind. The Harriet Klausner Appreciation Society had struck again.

Mrs. Klausner, a 60-year-old retired librarian who lives in Atlanta, has published an average of seven reviews a day for more than a decade. “To watch her in action is unbelievable,” said her husband, Stanley. “You see the pages turning.”

Mrs. Klausner, who says ailments keep her home and insomnia keeps her up, scoffs at her critics. “You ever read a Harlequin romance?” she said. “You can finish it in one hour. I’ve always been a speed reader.” She has a message for her naysayers: “Get a life. Read a book.”

More than 99.9 percent of Mrs. Klausner’s reviews are four or five stars. “If I can make it past the first 50 pages, that means I like it, and so I review it,” she said. But even Stanley said, “She’s soft, I won’t deny that.”

The campaign against Mrs. Klausner has pushed down her reviewer ratings, which in theory makes her less influential. But when everything is subject to review, the battle is never-ending.

Ragan Buckley, an aspiring novelist active in the campaign against Mrs. Klausner under the name “Sneaky Burrito,” is a little weary. “There are so many fake reviews that I’m often better off just walking into a physical store and picking an item off the shelf at random,” she said.

Read More..

Your Money: Walking the Tightrope on Mental Health Coverage

Insurance covers more mental health care than many people may realize, and more people will soon have the kind of health insurance that does so. But coverage goes only so far when there aren’t enough practitioners who accept it — or there aren’t any nearby, or they aren’t taking any new patients.

In the days after the Newtown, Conn., school shooting, parents and politicians took to the airwaves to make broad-based proclamations about the sorry state of mental health care in America. But a closer look reveals a more nuanced view, with a great deal of recent legislative progress as well as plenty of infuriating coverage gaps.

The stakes in any census of mental health insurance coverage are high given how many people are suffering. Twenty-six percent of adults experience a diagnosable mental disorder in any given year, and 6 percent of all adults experience a seriously debilitating mental illness, according to the National Institute of Mental Health. Twenty-one percent of teenagers experience a severe emotional disturbance between the ages of 13 and 18.

According to this year’s Society for Human Resource Management survey of 550 employers of all sizes, including nonprofits and government entities, 85 percent offer at least some mental health insurance coverage. A 2009 Mercer survey found that 84 percent of employers with more than 500 employees covered both in-network and out-of-network mental health and substance abuse treatments.

For now, some people who have no health insurance or who buy it on their own may avoid purchasing mental health coverage too, or may avoid seeking treatment for things like addiction or depression. This happens for many of the same reasons that there has historically been less mental health coverage than there has been for other illnesses. The earliest objections among insurance providers and employers had to do with whether mental disorders existed at all, according to Howard Goldman, a professor of psychiatry at the University of Maryland school of medicine. Then there were questions about whether treatment actually worked. Next, concerns arose over cost and how often people would avail themselves of costly mental health treatments.

But a subset of adults who have good insurance coverage still avoid treatment for mental illness to this day, according to Edward A. Kaplan, senior vice president and national practice leader for the Segal Company, a benefits consultant that works with many unions. “Culturally, a lot of people driving trucks don’t believe in it and suffer through,” he said. “And a lot of transport unions don’t trust employers and think they will look at it and use it to retaliate against the workers.”

For many of the people who do have mental health coverage, there is now a bit more of it at a lower cost than there might have been five years ago, even if mental health insurance over all remains much less generous than it was many years ago when employees did not pay as much out of pocket. That’s because a 2008 federal law requires employers with more than 50 employees that do offer mental health coverage to have no more restrictions than there are for physical injuries or surgery, and no higher costs.

This so-called parity bill now applies to a crucial provision of President Obama’s Affordable Care Act. Insurance plans in the exchanges that will offer health coverage to millions of uninsured individuals starting in 2014 must cover many items and services, including mental health disorders and substance abuse.

The combination of parity and expanded care is crucial, according to Anthony Wright, the executive director of Health Access, a consumer advocacy organization in California. After all, parity doesn’t do much good if the mental health coverage need only be equivalent to a meager health insurance plan that covers very little.

Then again, what good is parity in mental health insurance if you can’t get the treatment you need? Plenty of psychiatrists in private practice accept no insurance at all, though it is not clear how many; their professional organizations claim to have no recent or decent data on the percentage of people in private practice who take cash on the barrelhead, write people a receipt and send them off to their insurance company to request out-of-network reimbursement if they have any at all.

According to a 2008 American Psychological Association survey, 85 percent of the 2,200 respondents who said they worked at least part time in private practice received at least some third-party payments for their services. That doesn’t mean they take your insurance, though.

Nor does it guarantee that they or other mental health practitioners are anywhere near you or have any imminent openings for appointments. This can be a challenge for people who live far from major cities or big medical centers and need treatment for mental illnesses like severe depression or schizophrenia or disorders like autism.

But it is a particular problem for parents of autistic children who need specialized treatment that is relatively new or that not many people are trained to do. Amanda Griffiths, who lives in Carlisle, Pa., and is the mother of two autistic boys, called 17 providers within two hours of her home before finding one who was qualified to evaluate her younger son and was accepting new patients his age.

“No amount of insurance is going to magically make a provider appear,” she said.

And it remains a struggle to persuade insurance companies and employers to cover treatment that is new or expensive, even if it’s likely to be effective. Ira Burnim, legal director of the Bazelon Center for Mental Health Law, points to something called assertive community treatment, a team-based approach that has proved useful for adults with severe mental illness and holds promise for children, too. There, the challenge is to define what kinds of interaction with a patient outside of an office setting is billable and write rules for coverage.

Autistic children can benefit from an intensive treatment called applied behavior analysis, but many insurance companies haven’t wanted to cover what can be a $60,000 or $70,000 annual cost. They claim that the treatment, which can include intensive one-on-one interaction and assistance with both basic and more complex skills, is either too experimental or an educational service that schools should provide. This can be a tricky area for parents to navigate, because it isn’t always clear which part of an overall health insurance policy ought to cover various possible treatments.

A law school professor named Lorri Unumb faced a bill that big several years ago when her son Ryan was found to be autistic and she discovered that her insurance would not pay for treatment. After moving to South Carolina and meeting families there who had not been able to afford the therapy, she spent two years persuading state legislators to pass a law that forced insurance companies to pay for the treatment. “I did not really know how to write a bill,” she said. “I had watched ‘Schoolhouse Rock’ before, and that was kind of my inspiration and guidance.”

Autism Speaks, a national advocacy organization, saw what she accomplished and hired her to barnstorm the country in an effort to get similar laws passed. There are now 32 states that have them, though there’s a crucial catch: they don’t apply to the many large employers who pool their own resources in so-called self-funded insurance plans.

If you work in such a company, it may be up to you to lobby your human resources department to cover applied behavioral analysis or whatever mental health therapy you or your child may need. Sometimes a personal appeal will succeed; Mr. Kaplan, the benefits consultant, noted that when a parent called about a child, an employer might be particularly sensitive.

But a part of Ms. Unumb’s job these days is to assist parents with appeals where employers have said no or appear likely to. She has accompanied parents to meetings with their human resources departments all over the country to request that the employer expand coverage for everyone. She has a 115-page presentation that she draws on, pointing out that at its core, autism is a medical condition diagnosed by a doctor, the very thing health insurance is supposed to cover.

At $60,000 or more annually for children with particularly acute treatment needs, the coverage does not come cheaply. But Autism Speaks estimates that that expense, spread over thousands of employees, raises premium costs 31 cents a month.

Ms. Unumb notes that for many autistic children, intensive early intervention can allow them to function in mainstream classrooms and prevent a host of problems there and once they finish school. “You pay for it now or you pay for it later,” she said. “And you pay for it a lot more if you choose later, in more ways than just financial.”

Read More..

Your Money: Walking the Tightrope on Mental Health Coverage

Insurance covers more mental health care than many people may realize, and more people will soon have the kind of health insurance that does so. But coverage goes only so far when there aren’t enough practitioners who accept it — or there aren’t any nearby, or they aren’t taking any new patients.

In the days after the Newtown, Conn., school shooting, parents and politicians took to the airwaves to make broad-based proclamations about the sorry state of mental health care in America. But a closer look reveals a more nuanced view, with a great deal of recent legislative progress as well as plenty of infuriating coverage gaps.

The stakes in any census of mental health insurance coverage are high given how many people are suffering. Twenty-six percent of adults experience a diagnosable mental disorder in any given year, and 6 percent of all adults experience a seriously debilitating mental illness, according to the National Institute of Mental Health. Twenty-one percent of teenagers experience a severe emotional disturbance between the ages of 13 and 18.

According to this year’s Society for Human Resource Management survey of 550 employers of all sizes, including nonprofits and government entities, 85 percent offer at least some mental health insurance coverage. A 2009 Mercer survey found that 84 percent of employers with more than 500 employees covered both in-network and out-of-network mental health and substance abuse treatments.

For now, some people who have no health insurance or who buy it on their own may avoid purchasing mental health coverage too, or may avoid seeking treatment for things like addiction or depression. This happens for many of the same reasons that there has historically been less mental health coverage than there has been for other illnesses. The earliest objections among insurance providers and employers had to do with whether mental disorders existed at all, according to Howard Goldman, a professor of psychiatry at the University of Maryland school of medicine. Then there were questions about whether treatment actually worked. Next, concerns arose over cost and how often people would avail themselves of costly mental health treatments.

But a subset of adults who have good insurance coverage still avoid treatment for mental illness to this day, according to Edward A. Kaplan, senior vice president and national practice leader for the Segal Company, a benefits consultant that works with many unions. “Culturally, a lot of people driving trucks don’t believe in it and suffer through,” he said. “And a lot of transport unions don’t trust employers and think they will look at it and use it to retaliate against the workers.”

For many of the people who do have mental health coverage, there is now a bit more of it at a lower cost than there might have been five years ago, even if mental health insurance over all remains much less generous than it was many years ago when employees did not pay as much out of pocket. That’s because a 2008 federal law requires employers with more than 50 employees that do offer mental health coverage to have no more restrictions than there are for physical injuries or surgery, and no higher costs.

This so-called parity bill now applies to a crucial provision of President Obama’s Affordable Care Act. Insurance plans in the exchanges that will offer health coverage to millions of uninsured individuals starting in 2014 must cover many items and services, including mental health disorders and substance abuse.

The combination of parity and expanded care is crucial, according to Anthony Wright, the executive director of Health Access, a consumer advocacy organization in California. After all, parity doesn’t do much good if the mental health coverage need only be equivalent to a meager health insurance plan that covers very little.

Then again, what good is parity in mental health insurance if you can’t get the treatment you need? Plenty of psychiatrists in private practice accept no insurance at all, though it is not clear how many; their professional organizations claim to have no recent or decent data on the percentage of people in private practice who take cash on the barrelhead, write people a receipt and send them off to their insurance company to request out-of-network reimbursement if they have any at all.

According to a 2008 American Psychological Association survey, 85 percent of the 2,200 respondents who said they worked at least part time in private practice received at least some third-party payments for their services. That doesn’t mean they take your insurance, though.

Nor does it guarantee that they or other mental health practitioners are anywhere near you or have any imminent openings for appointments. This can be a challenge for people who live far from major cities or big medical centers and need treatment for mental illnesses like severe depression or schizophrenia or disorders like autism.

But it is a particular problem for parents of autistic children who need specialized treatment that is relatively new or that not many people are trained to do. Amanda Griffiths, who lives in Carlisle, Pa., and is the mother of two autistic boys, called 17 providers within two hours of her home before finding one who was qualified to evaluate her younger son and was accepting new patients his age.

“No amount of insurance is going to magically make a provider appear,” she said.

And it remains a struggle to persuade insurance companies and employers to cover treatment that is new or expensive, even if it’s likely to be effective. Ira Burnim, legal director of the Bazelon Center for Mental Health Law, points to something called assertive community treatment, a team-based approach that has proved useful for adults with severe mental illness and holds promise for children, too. There, the challenge is to define what kinds of interaction with a patient outside of an office setting is billable and write rules for coverage.

Autistic children can benefit from an intensive treatment called applied behavior analysis, but many insurance companies haven’t wanted to cover what can be a $60,000 or $70,000 annual cost. They claim that the treatment, which can include intensive one-on-one interaction and assistance with both basic and more complex skills, is either too experimental or an educational service that schools should provide. This can be a tricky area for parents to navigate, because it isn’t always clear which part of an overall health insurance policy ought to cover various possible treatments.

A law school professor named Lorri Unumb faced a bill that big several years ago when her son Ryan was found to be autistic and she discovered that her insurance would not pay for treatment. After moving to South Carolina and meeting families there who had not been able to afford the therapy, she spent two years persuading state legislators to pass a law that forced insurance companies to pay for the treatment. “I did not really know how to write a bill,” she said. “I had watched ‘Schoolhouse Rock’ before, and that was kind of my inspiration and guidance.”

Autism Speaks, a national advocacy organization, saw what she accomplished and hired her to barnstorm the country in an effort to get similar laws passed. There are now 32 states that have them, though there’s a crucial catch: they don’t apply to the many large employers who pool their own resources in so-called self-funded insurance plans.

If you work in such a company, it may be up to you to lobby your human resources department to cover applied behavioral analysis or whatever mental health therapy you or your child may need. Sometimes a personal appeal will succeed; Mr. Kaplan, the benefits consultant, noted that when a parent called about a child, an employer might be particularly sensitive.

But a part of Ms. Unumb’s job these days is to assist parents with appeals where employers have said no or appear likely to. She has accompanied parents to meetings with their human resources departments all over the country to request that the employer expand coverage for everyone. She has a 115-page presentation that she draws on, pointing out that at its core, autism is a medical condition diagnosed by a doctor, the very thing health insurance is supposed to cover.

At $60,000 or more annually for children with particularly acute treatment needs, the coverage does not come cheaply. But Autism Speaks estimates that that expense, spread over thousands of employees, raises premium costs 31 cents a month.

Ms. Unumb notes that for many autistic children, intensive early intervention can allow them to function in mainstream classrooms and prevent a host of problems there and once they finish school. “You pay for it now or you pay for it later,” she said. “And you pay for it a lot more if you choose later, in more ways than just financial.”

Read More..

As Shoppers Hop From Tablet to PC to Phone, Retailers Try to Adapt

Ryan O’Neil, a Connecticut government employee, was in the market to buy a digital weather station this month. His wife researched options on their iPad, but even though she found the lowest-price option there, Mr. O’Neil made the purchase on his laptop.

“I do use the iPad to browse sites,” Mr. O’Neil said, but when it comes time to close the deal, he finds it easier to do on a computer.

Many online retailers had visions of holiday shoppers lounging beneath the Christmas tree with their mobile devices in hand, making purchases. The size of the average order on tablets, particularly iPads, tends to be bigger than on PCs. So retailers poured money and marketing into mobile Web sites and apps with rich images and, they thought, easy checkout.

But while visits to e-commerce sites and apps on tablets and phones have nearly doubled since last year, consumers like Mr. O’Neil are more frequently using multiple devices to shop. In many cases, they are more comfortable making the final purchase on a computer, with its bigger screen and keyboard. So retailers are trying to figure out how to appeal to a shopper who may use a cellphone to research products, a tablet to browse the options and a computer to buy.

“I’ve been yelling at customers for two years, saying, ‘Mobile, mobile, mobile,’ ” said Jason Spero, director of mobile sales and strategy at Google. “But the funny thing is, now we’re going to say: ‘Don’t put mobile in a silo. It’s also about the desktop.’ ”

The challenges are daunting, though. It is technically difficult to track consumers as they hop from phone to computer to tablet and back again. This means customers who, say, fill shopping carts on their tablets have to do all the work again on their PCs or other devices. The biggest obstacle, retailers say, is that the tools used to track shoppers on computers — cookies, or bundles of data stored in Web browsers — don’t transfer across devices.

Instead, retailers are figuring out how to sync the experience in other ways, like prompting shoppers to log in on each device. And being able to track people across devices gives retailers more insight into how they shop.

The retailers’ efforts are backed by research. While one-quarter of the visits to e-commerce sites occur on mobile devices, only around 15 percent of purchases do, according to data from I.B.M. According to Google, 85 percent of online shoppers start searching on one device — most often a mobile phone — and make a purchase on another.

At eBags, customers are shopping on their tablets in the evening and returning on their work computers the next day. But eBags has not yet synced the shoppers across devices, so customers must build their shopping carts from scratch if they switch devices.

“That is a blind spot with a lot of sites,” said Peter Cobb, co-founder of eBags. “It is a requirement moving forward.”

At eBay, one-third of the purchases involve mobile devices at some point, even if the final purchase is made on a computer.

At eBay, once shoppers log in on a device, they do not need to log in again. Their information, like shipping and credit card details and saved items, syncs across all their devices. If an eBay shopper is interested in a certain handbag, and saves that search on a computer, eBay will send alerts to her cellphone when a new handbag arrives or an auction is about to end.

“They might discover an item on a phone or tablet, do a saved-search push alert later on some other screen and eventually close on the Web site,” said Steve Yankovich, who runs eBay Mobile. “People are buying and shopping and consuming potentially every waking moment of the day.”

ModCloth, an e-commerce site for women’s clothes, said that while a quarter of its visits come from mobile devices, people are not yet buying there in the same proportion, though they are becoming more comfortable with checking out on those devices.

“She’s visiting us more on the phone, but she’s actually transacting somewhere else,” said Sarah Rose, vice president of product at ModCloth.

For example, a shopper will skim through new arrivals on her phone while on the bus and add items to her wish list, then visit that evening on her tablet to make a purchase, Ms. Rose said.

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Monti Resigns in Italy, but May Seek to Regain Office

ROME — Prime Minister Mario Monti resigned on Friday evening following Parliament’s confidence vote on the 2013 budget, but he is still expected to play a major role in early elections, possibly as a candidate, analysts said.

At a news conference scheduled for Sunday, Mr. Monti is expected to present a political agenda — pro-Europe and pro-fiscal rigor — and call on all parties to endorse it, aides said Friday. Mr. Monti, an economist who has helped restore Italy’s international credibility but has suffered politically for championing a series of tax increases and budget cuts, has steadfastly refused to say whether he will run for prime minister or present an agenda that he hopes parties will endorse. Whether he does run or not, however, he has already radically shifted Italy’s political landscape.

With Italy facing economic uncertainty and sluggish growth, Mr. Monti has emerged as a centrist force in a field previously divided between the center-left Democratic Party of Pier Luigi Bersani, which opinion polls place first, and former Prime Minister Silvio Berlusconi, who has risen in polls since taking to the airwaves with a populist message critical of Mr. Monti’s tax increases.

“He’s de facto a candidate. He is the head politician of this coalition,” said Stefano Folli, a columnist for the business daily Il Sole 24 Ore, referring to a centrist grouping that has been courting Mr. Monti.

On Friday evening, Mr. Monti handed in his resignation to President Giorgio Napolitano, who in a tough speech to lawmakers last week lamented the “brusque” end of the government and Parliament’s failure to carry out significant structural changes in Italy’s encrusted economy.

Mr. Napolitano is soon expected to dissolve Parliament, opening a hard-fought campaign amid rising unemployment, taxes and populism. Mr. Monti will stay on as caretaker prime minister until a new government is formed. In that time, he is expected to retain the power to pass emergency legislation.

“He’s already a senator for life, so he doesn’t have to become a candidate in the technical way,” Mr. Folli added.

After losing the support of Mr. Berlusconi’s People of Liberty party this month, Mr. Monti said that he would step down after the budget was passed. On Friday, lawmakers voted 373 in favor and 67 against with 15 abstentions in a confidence vote over the budget, which stipulates spending cuts of $4.8 billion through 2015.

Mr. Monti could run as a candidate or endorse a centrist alliance that includes a veteran political party, the Union of Christian Democrats, and Toward the Third Republic, a fledgling civic movement led by the chairman of Ferrari, Luca Cordero di Montezemolo. If Mr. Monti lends his name to the centrists, he is expected to draw moderates from Mr. Berlusconi’s party. Mr. Monti also has the implicit support of the Catholic Church, which is crucial to the survival of any Italian government.

After weeks of wavering, Mr. Monti seems to have decided to stay involved in Italian politics after other European leaders, concerned about the prospect of an increasingly populist Mr. Berlusconi, urged him to stay in the picture.

Last week, members of the European People’s Party, a group of center-right parties across Europe, asked the unelected Mr. Monti to attend a summit in Brussels, which Mr. Berlusconi attended as the head of Italy’s largest center-right party. “I can say that there was massive support from E.P.P. members that Monti should remain at the helm of Italy,” said Kostas Sasmatzoglou, the group’s spokesman.

“It was Europe pushing him to continue,” Mr. Folli, the columnist, said. “Germany already has Hollande,” he said, referring to France’s Socialist prime minister, François Hollande. “It doesn’t want another country to go to the left, to go back on fiscal rigor.”

He added: “It can have Bersani, but Bersani ‘corrected’ and supported by Monti.”

Indeed, if he lends them his support, Mr. Monti and the centrist groupings are not expected to get more than 15 percent of the vote. Mr. Bersani’s Democratic Party is expected to place first, but without enough votes to govern in both houses even if it allies with the smaller Left Ecology and Freedom party. It remains to be seen if the center will take votes away from Mr. Berlusconi or Mr. Bersani.

On Thursday, Mr. Monti was widely perceived to have begun his campaign with a politically calculated speech at a Fiat automotive plant in southern Italy. With Fiat’s chairman, Sergio Marchionne, by his side, he said that Italy needed to stay the course on structural changes. The speech effectively challenged Mr. Bersani, a moderate who will most likely have to tack further left.

Mr. Monti came to power in November 2011, replacing Mr. Berlusconi amid global financial panic. He helped burnish Italy’s image abroad, but effectively raised taxes, worsening Italy’s recession. Although populists have depicted Mr. Monti and his government as a puppet of Europe and the banks, many Italians support him as a needed change from politics as usual.

“I prefer Monti to Berlusconi or any other politician, even if he left us in our underwear,” said Annalisa di Piero, 50, a costume designer and stylist, referring to the tax increases that have left Italians with less in their pockets in the holiday shopping season. “I just paid my property tax, but I still prefer him to these other clowns.”

Gaia Pianigiani contributed reporting.

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U.S. Makes Arrest in Olympus Accounting Scandal

Federal agents arrested a former bank executive in Los Angeles on Thursday in connection with the accounting scandal that erupted last year at Olympus, the Japanese camera and medical equipment maker.

Prosecutors in New York said that the executive, Chan Ming Fon, received more than $10 million from Olympus for assisting in its accounting fraud.

The Federal Bureau of Investigation said Mr. Chan, 50, was a citizen of Taiwan living in Singapore. He was charged with conspiracy to commit wire fraud, with a maximum potential penalty of 20 years in prison. His lawyer was not disclosed.

“As alleged, Chan Ming Fon was handsomely paid to play an international shell game with hundreds of millions of dollars of assets in order to allow Olympus to keep a massive accounting fraud going for years,” said Preet Bharara, the United States attorney in Manhattan, in a news release.

The authorities did not identify the financial institutions with which Mr. Chan was affiliated.

In February, the Japanese authorities arrested seven people in connection with the accounting missteps at Olympus, including Tsuyoshi Kikukawa, the company’s former chairman. Mr. Chan was not among those seven.

The company has admitted that executives set up a scheme to cover up $1.7 billion in losses. The illicit maneuvers came to light after Olympus fired Michael C. Woodford, its British chief executive, in October 2011. Soon after, Mr. Woodford made allegations of accounting misdeeds at Olympus.

The Olympus scandal rocked the Japanese corporate sector. The case is being watched closely to gauge how serious the Japanese authorities will be in their pursuit of white-collar crime. The men arrested in February could each serve up to 10 years if found guilty.

The allegations against Mr. Chan could shed more light on Olympus’s elaborate accounting ruses. The company hid losses sustained in the 1990s, later masking them with inflated acquisitions and payments through shadowy overseas funds.

Mr. Chan was a principal at a fund that received large payments from Olympus, according to the F.B.I. The bureau contends that Mr. Chan told Olympus’s auditors in 2009 that the fund held hundreds of millions of dollars on behalf of Olympus, in the form of conservative investments like Japanese government bonds. The complaint says, however, that the money had been passed on to an entity controlled by Olympus to pay off a loan.

In the complaint, the F.B.I. said that Mr. Chan “acknowledged that it was wrong to assist Olympus in deceiving its auditor.”

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Amgen Workers Helped U.S. in Aranesp Marketing Inquiry

“I hope no one is taping this,” the Amgen manager remarked at a company sales meeting in 2005.

The manager then boasted of how she had given a $10,000 unrestricted grant to a pet project of a doctor who was an adviser to the local Medicare contractor. In turn, she said, the doctor would help persuade the contractor to provide reimbursement for an unapproved use of Amgen’s anemia drug, Aranesp.

Someone, it turned out, was taping it. Jill Osiecki, a longtime sales representative at Amgen, was wearing a recording device under her clothes, transmitting the proceedings to agents of the Department of Health and Human Services.

The result of Ms. Osiecki’s undercover work, and information provided by other whistle-blowers, led to Amgen’s agreement this week to pay $762 million to settle federal investigations regarding the marketing of some of its top-selling drugs.

Judge Sterling Johnson Jr. of Federal District Court in Brooklyn accepted the settlement on Wednesday, clearing the way for 10 whistle-blower lawsuits to be unsealed.

Amgen, the world’s largest biotechnology company, will pay $150 million in criminal penalties after pleading guilty to one misdemeanor count of marketing Aranesp for unapproved uses and in unapproved doses.

The rest of the money — $612 million — will go to settle civil false claims lawsuits filed by the federal government, states and whistle-blowers. These contain accusations that go well beyond the off-label marketing of Aranesp.

They include off-label marketing of other drugs like Enbrel for psoriasis and Neulasta, which increases the levels of white blood cells. Amgen is also accused of offering kickbacks to doctors and clinics to induce them to use its drugs. These reportedly came as cash, rebates, free samples, educational and research grants, dinners and travel, and other inducements. The government also accused the company of knowingly misreporting the prices of some of its drugs.

Except for those in the criminal count, Amgen denied the other accusations, though it did issue a statement on Wednesday acknowledging the settlement.

“The government raised important concerns in the criminal prosecution,” Cynthia M. Patton, chief compliance officer at Amgen, said in the statement. “Amgen acknowledges that mistakes were made, and we did not live up to our standards.”

Ms. Osiecki, 52, was one of the main whistle-blowers and will be entitled to a share of the settlement. The amount each whistle-blower will receive has not been determined or is being kept confidential, their lawyers said.

Ms. Osiecki worked as a sales representative for Merck for nine years before joining Amgen in 1990, soon after the biotechnology company won regulatory approval for its first product. The company, based outside Los Angeles, had “good science, good products, strong ethics,” Ms. Osiecki said in an interview.

But, she said, the corporate culture changed starting around 2000. That was when new management came in and Aranesp was approved, setting up a fierce marketing battle with Johnson & Johnson and its rival anemia drug, Procrit.

“It was more important to make your numbers than to follow the rules,” said Ms. Osiecki, who was based in Milwaukee and sold Aranesp.

In August 2004, with her concerns mounting, Ms. Osiecki called the Office of Inspector General of the Department of Health and Human Services and left a message. Within days, she was called back, and she went to see an agent, who persuaded her to secretly record meetings. She did that 13 times over about 15 months, mainly sales meetings.

Aranesp is used mainly in a hospital, clinic or physician’s office. It is bought by the medical practice, which can make a profit if the patient and insurers pay more for the use of the drug than the practice paid.

Ms. Osiecki said Amgen “marketed the spread,” trying to make it more profitable for doctors to use Aranesp rather than Procrit.

Such financial inducements could also spur greater overall use of a drug and can violate anti-kickback laws, said Ms. Osiecki’s lawyer, Brian P. Kenney of Kenney & McCafferty in Blue Bell, Pa.

Ms. Osiecki said the first sales meeting at which she wore the recording device, wrapped around her midriff under baggy clothes, was in October 2004 in a Milwaukee hotel. She could look down from the meeting room and see the car parked across the street containing the agent with the receiving device. She said she was not particularly nervous.

The speaker was a pharmacist from an oncology practice going through the numbers on how his practice could make a million dollars more a year using Aranesp rather than Procrit.

Ms. Osiecki said Amgen was careful to cover up such marketing. Spreadsheets showing doctors how much more money they could make using Aranesp were “homemade bread,” meaning they were created by each sales representative, not by the company. And representatives were told not to leave the presentations behind after showing them to doctors.

Her 107-page complaint, filed in late 2004, contains many other accusations.

Other whistle-blowers made other accusations. Kassie Westmoreland, a former sales representative, said Amgen overfilled vials of Aranesp, essentially providing free drugs to doctors. They could then bill Medicare or private insurers for the use of that drug, making an extra profit.

“Amgen was offering a kickback in the form of extra product subsidized by the taxpayers,” said Robert M. Thomas Jr., one of Ms. Westmoreland’s lawyers.

Elena Ferrante and Marc Engelman, both former sales representatives, contended that Amgen promoted Enbrel’s off-label use for mild psoriasis when the drug was approved only for moderate or severe cases of the disease.

Lydia Cotz, one of their lawyers, said the two refused to go along with the off-label marketing. They are now pursuing wrongful termination claims against Amgen in arbitration proceedings that Amgen requires be kept confidential, she said.

“It’s been a very long heroic journey for my clients,” she said.

Ms. Osiecki is now also a former Amgen sales representative. She said that she was fired in December 2005 after she let slip that she had retained a company voice mail message that she thought provided evidence of illegal activity. Leaving the pharmaceutical industry, she moved to Amelia Island, Fla. She now works for a small business.

Mosi Secret and Barry Meier contributed reporting.

Read More..

Amgen Workers Helped U.S. in Aranesp Marketing Inquiry

“I hope no one is taping this,” the Amgen manager remarked at a company sales meeting in 2005.

The manager then boasted of how she had given a $10,000 unrestricted grant to a pet project of a doctor who was an adviser to the local Medicare contractor. In turn, she said, the doctor would help persuade the contractor to provide reimbursement for an unapproved use of Amgen’s anemia drug, Aranesp.

Someone, it turned out, was taping it. Jill Osiecki, a longtime sales representative at Amgen, was wearing a recording device under her clothes, transmitting the proceedings to agents of the Department of Health and Human Services.

The result of Ms. Osiecki’s undercover work, and information provided by other whistle-blowers, led to Amgen’s agreement this week to pay $762 million to settle federal investigations regarding the marketing of some of its top-selling drugs.

Judge Sterling Johnson Jr. of Federal District Court in Brooklyn accepted the settlement on Wednesday, clearing the way for 10 whistle-blower lawsuits to be unsealed.

Amgen, the world’s largest biotechnology company, will pay $150 million in criminal penalties after pleading guilty to one misdemeanor count of marketing Aranesp for unapproved uses and in unapproved doses.

The rest of the money — $612 million — will go to settle civil false claims lawsuits filed by the federal government, states and whistle-blowers. These contain accusations that go well beyond the off-label marketing of Aranesp.

They include off-label marketing of other drugs like Enbrel for psoriasis and Neulasta, which increases the levels of white blood cells. Amgen is also accused of offering kickbacks to doctors and clinics to induce them to use its drugs. These reportedly came as cash, rebates, free samples, educational and research grants, dinners and travel, and other inducements. The government also accused the company of knowingly misreporting the prices of some of its drugs.

Except for those in the criminal count, Amgen denied the other accusations, though it did issue a statement on Wednesday acknowledging the settlement.

“The government raised important concerns in the criminal prosecution,” Cynthia M. Patton, chief compliance officer at Amgen, said in the statement. “Amgen acknowledges that mistakes were made, and we did not live up to our standards.”

Ms. Osiecki, 52, was one of the main whistle-blowers and will be entitled to a share of the settlement. The amount each whistle-blower will receive has not been determined or is being kept confidential, their lawyers said.

Ms. Osiecki worked as a sales representative for Merck for nine years before joining Amgen in 1990, soon after the biotechnology company won regulatory approval for its first product. The company, based outside Los Angeles, had “good science, good products, strong ethics,” Ms. Osiecki said in an interview.

But, she said, the corporate culture changed starting around 2000. That was when new management came in and Aranesp was approved, setting up a fierce marketing battle with Johnson & Johnson and its rival anemia drug, Procrit.

“It was more important to make your numbers than to follow the rules,” said Ms. Osiecki, who was based in Milwaukee and sold Aranesp.

In August 2004, with her concerns mounting, Ms. Osiecki called the Office of Inspector General of the Department of Health and Human Services and left a message. Within days, she was called back, and she went to see an agent, who persuaded her to secretly record meetings. She did that 13 times over about 15 months, mainly sales meetings.

Aranesp is used mainly in a hospital, clinic or physician’s office. It is bought by the medical practice, which can make a profit if the patient and insurers pay more for the use of the drug than the practice paid.

Ms. Osiecki said Amgen “marketed the spread,” trying to make it more profitable for doctors to use Aranesp rather than Procrit.

Such financial inducements could also spur greater overall use of a drug and can violate anti-kickback laws, said Ms. Osiecki’s lawyer, Brian P. Kenney of Kenney & McCafferty in Blue Bell, Pa.

Ms. Osiecki said the first sales meeting at which she wore the recording device, wrapped around her midriff under baggy clothes, was in October 2004 in a Milwaukee hotel. She could look down from the meeting room and see the car parked across the street containing the agent with the receiving device. She said she was not particularly nervous.

The speaker was a pharmacist from an oncology practice going through the numbers on how his practice could make a million dollars more a year using Aranesp rather than Procrit.

Ms. Osiecki said Amgen was careful to cover up such marketing. Spreadsheets showing doctors how much more money they could make using Aranesp were “homemade bread,” meaning they were created by each sales representative, not by the company. And representatives were told not to leave the presentations behind after showing them to doctors.

Her 107-page complaint, filed in late 2004, contains many other accusations.

Other whistle-blowers made other accusations. Kassie Westmoreland, a former sales representative, said Amgen overfilled vials of Aranesp, essentially providing free drugs to doctors. They could then bill Medicare or private insurers for the use of that drug, making an extra profit.

“Amgen was offering a kickback in the form of extra product subsidized by the taxpayers,” said Robert M. Thomas Jr., one of Ms. Westmoreland’s lawyers.

Elena Ferrante and Marc Engelman, both former sales representatives, contended that Amgen promoted Enbrel’s off-label use for mild psoriasis when the drug was approved only for moderate or severe cases of the disease.

Lydia Cotz, one of their lawyers, said the two refused to go along with the off-label marketing. They are now pursuing wrongful termination claims against Amgen in arbitration proceedings that Amgen requires be kept confidential, she said.

“It’s been a very long heroic journey for my clients,” she said.

Ms. Osiecki is now also a former Amgen sales representative. She said that she was fired in December 2005 after she let slip that she had retained a company voice mail message that she thought provided evidence of illegal activity. Leaving the pharmaceutical industry, she moved to Amelia Island, Fla. She now works for a small business.

Mosi Secret and Barry Meier contributed reporting.

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Adding to Rules for Online Privacy

In a move intended to give parents greater control over data collected about their children online, federal regulators on Wednesday broadened longstanding privacy safeguards covering children’s mobile apps and Web sites. Members of the Federal Trade Commission said they updated the rules to keep pace with the growing use of mobile phones and tablets by children.

The regulations also reflect innovations like voice recognition technology, global positioning systems and behavior-based online advertising, or ads tailored to an individual Internet user.

Regulators had not significantly changed the original rule, based on the Children’s Online Privacy Protection Act of 1998, or Coppa. That rule required operators of Web sites directed at children under 13 to notify parents and obtain their permission before collecting or sharing personal information — like first and last names, phone numbers, home addresses or e-mail addresses — from children.

The intent of that was to give parents control over entities seeking to collect information about their children so that parents could, among other things, prevent unwanted contact by strangers.

The new rule, unveiled at a news conference in Washington, significantly expands the types of companies required to obtain parental permission before knowingly collecting personal details from children, as well as the types of information that will require parental consent to collect.

Jon D. Leibowitz, the chairman of the trade commission, described the rule revision as a major advance for children’s privacy. “Congress enacted Coppa in the desktop era and we live in an era of smartphones and mobile marketing,” Mr. Leibowitz said. “This is a landmark update of a seminal piece of legislation.”

The agency’s expanded privacy protections for children also represent the first step in a larger effort by a few regulators and legislators to give adult consumers some rights to control data collected about them.

“The Coppa rule revisions which we are announcing today are a critical piece in our overall approach to how we deal with consumer privacy in this technological age,” said Julie Brill, a member of the commission.

Industry analysts said the new rule represented a partial victory for Web site operators, app developers and advertising networks because regulators watered down some of their original proposals to which companies like Apple, Facebook, Google and Twitter had objected. Apple and Google, for example, opposed proposals that suggested they would be responsible for the data collected by children’s apps sold in their app stores. Regulators have now clarified that general-interest app stores would not be held liable for that.

Yet, few companies lent any support to the commission at its news conference; Viacom and Disney sent representatives, but other companies were absent.

“What we’ve got here is an expansion of Coppa that some in the industry would say has gone too far,” said Alan Friel, a lawyer who leads the media and technology practice at the firm of Edwards Wildman Palmer. “But the F.T.C. has provided exceptions that continue to allow internal use of a child’s data, including one-time use of contact information for facilitating promotions and send-a-friend e-mails.”

In an era of widespread photo sharing, video chatting and location-based apps, the revised children’s privacy rule makes clear that companies must obtain parental consent before collecting certain details that could be used to identify, contact or locate a child. These include photos, video and audio as well as the location of a child’s mobile device.

While the new rule strengthens such safeguards, it could also disrupt online advertising. Web sites and online advertising networks often use persistent identification systems — like a cookie in a person’s browser, the unique serial number on a mobile phone, or the I.P. address of a computer — to collect information about a user’s online activities and tailor ads for that person.

The new rule expands the definition of personal information to include persistent IDs if they are used to show a child behavior-based ads. It also requires third parties like ad networks and social networks that know they are operating on children’s sites to notify and obtain consent from parents before collecting such personal information. And it makes children’s sites responsible for notifying parents about data collection by third parties integrated into their services.

Collecting data to show children contextual ads based on the content of a site or app, however, will not require parental consent. “The only limit we place is on behavioral advertising,” Mr. Leibowitz said. “Until and unless you get parental consent, you may not track children to create massive profiles” for behavior-based ads.

Stuart P. Ingis, a lawyer representing several marketing associations, said that reputable online marketers did not knowingly profile children to show them behavior-based ads. He added that industry guidelines prohibited the practice.

He agreed with regulators that privacy protections for children online needed to keep pace with new technologies. But he said he was concerned that the restrictions on cookie-based identifiers might cause some children’s sites to reduce their use of ad networks to avoid having to notify parents about data collection by those services.

“There might be overreaction that would limit just general third-party collection of data, which is very useful to businesses and consumers,” said Mr. Ingis, who represents the Direct Marketing Association and the Association of National Advertisers.

The revised rule also clarifies requirements for sites that are not primarily directed at young children but whose audience may include them, like a Disney family site, for example. Those sites can now screen visitors by age, but they will be required to obtain permission from a parent to collect personal data about children under 13.

Children’s advocates generally welcomed the strengthened protections.

“Clearly, this is a major step forward, but the devil is in the details,” said Jeffrey Chester, the executive director of the Center for Digital Democracy, an advocacy group in Washington.

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Three State Department Officials Resign After Benghazi Report

WASHINGTON — Three State Department officials resigned on Wednesday after an independent panel criticized the “grossly inadequate” security at a diplomatic compound in Benghazi, Libya, that was attacked on Sept. 11, leading to the deaths of Ambassador J. Christopher Stevens and three other Americans.

The officials were Eric J. Boswell, the assistant secretary of state for diplomatic security; Charlene R. Lamb, the deputy assistant secretary responsible for embassy security; and Raymond Maxwell, a deputy assistant secretary who had responsibility for North Africa, an administration official said.

The panel’s classified report identified officials in the State Department’s Bureau for Diplomatic Security whose performance reflected a “lack of proactive leadership,” and complained that the Bureau of Near Eastern Affairs had displayed a “lack of ownership of Benghazi’s security issues.”

The report did not criticize any other senior officials, including Patrick F. Kennedy, the under secretary for management, who has vigorously defended the State Department’s decision-making on Benghazi to Congress, or Secretary of State Hillary Rodham Clinton.

At a news conference at the State Department on Wednesday, Thomas R. Pickering, a former ambassador who led the independent review, said that most of the blame should fall on officials in the two bureaus.

“We fixed it at the assistant secretary level, which is, in our view, the appropriate place to look, where the decision-making in fact takes place, where, if you like, the rubber hits the road,” said Mr. Pickering, who did not identify the officials.

At the same time, the report that Mr. Pickering oversaw suggested that there was a culture of “husbanding resources” at senior levels of the State Department that contributed to the security deficiencies in Benghazi. Without identifying Mr. Kennedy or other senior officials, the report said that attitude “had the effect of conditioning a few State Department managers to favor restricting the use of resources as a general orientation.”

Two deputy secretaries of state, William J. Burns and Thomas R. Nides, are scheduled to testify to Congressional committees on Thursday. The question of whether senior officials at the State Department should be held accountable is likely to be raised by lawmakers at the hearing.

“The board severely critiques a handful of individuals, and they have been held accountable,” said Representative Ed Royce, Republican of California, who is the incoming chairman of the House Foreign Affairs Committee. “The degree that others bear responsibility warrants Congressional review, given the report’s rather sweeping indictment. And the Foreign Affairs Committee must hear from Secretary Clinton concerning her role, which this report didn’t address.”

Mrs. Clinton, in a letter to Congress, outlined a number of steps the department is taking to improve security, including hiring hundreds of additional Marine guards for high-risk embassies and consulates around the world.

Another issue, which might be raised and which was largely skirted by the independent panel, concerns what role the American military should play in protecting diplomats abroad.

The Pentagon had no forces that could be readily sent to Benghazi when the crisis unfolded. The closest AC-130 gunship was in Afghanistan. There are no armed drones thought to be within range of Libya. There was no Marine expeditionary unit — a large seaborne force with its own helicopters — in the Mediterranean Sea. The Africa Command, whose area of operation includes North Africa, also did not have on hand its own force able to respond rapidly to emergencies — a Commanders’ In-Extremis Force, or C.I.F. Every other regional combatant command had one at the time.

The Defense Department has repeatedly declined to say whether the Africa Command requested that any of these forces be on hand during the anniversary of the Sept. 11, 2001, terrorist attacks. Nor has it said whether Defense Secretary Leon E. Panetta or Gen. Martin E. Dempsey, the chairman of the Joint Chiefs of Staff, gave any thought to moving forces in the region as a precaution.

The unclassified version of the Benghazi report concluded that “there simply was not enough time given the speed of the attacks for armed U.S. military assets to have made a difference.” But the report did not address whether it would have been prudent to station quick-reaction forces in the region or whether the United States would have been in a position to quickly respond militarily had Ambassador Stevens been kidnapped and the crisis dragged on, as was initially feared.

The United States military’s best-trained team to extract diplomats under fire — Delta Force commandos — was half a world away, in Fort Bragg, N.C., and by the estimates of both military officials and some members of the investigation panel, it would have taken at least 18 hours, and perhaps considerably longer, for those commandos to get into the city. By that time, Mr. Stevens and three others were dead.

“What this report shows is that we need a fundamental rethink of the problem,” said one senior Pentagon official who has spent considerable time examining the issue of protecting American diplomats since the attack in September. “It’s not the military’s job to protect diplomats; it’s the host government’s. But in the absence of a real government, we never asked the question, ‘So how do we do this?’ ”

Gen. Carter F. Ham, the head of the Africa Command, indicated in a recent appearance at George Washington University that the question of whether the military should adjust its deployments to respond to diplomatic compounds under threat was being discussed.

But as the military budget declines, some ranking officers are wary about taking on new commitments, even ones that involve protecting Americans.

“It is not reasonable nor feasible to tether U.S. forces at the ready to respond to protect every high-risk post in the world,” Mike Mullen, the retired admiral and former chairman of the Joint Chiefs of Staff, who served as vice chairman of the independent review, said Wednesday.

David E. Sanger contributed reporting.

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