FDA approves brain-zapping device to relieve OCD
By MATTHEW PERRONE
AP Business Writer
WASHINGTON (AP) — Patients suffering from obsessive, distressing thoughts have a new treatment option: a pacemaker-like device that relieves anxiety with electrical jolts to the brain.
The Food and Drug Administration on Thursday approved Medtronic’s Reclaim Deep Brain Stimulator device as the first implant to treat obsessive-compulsive disorder, which causes uncontrollable worries, such as fear of germs or dirt.
Patients suffering from the disorder try to relieve their anxiety with obsessive behavior, such as washing their hands or checking locks repeatedly.
“These are obtrusive thoughts that take control of people’s lives to the point that they lose their jobs, can’t have relationships and in many cases, can’t even leave their homes,” said Dr. Hooman Azmi of Hackensack University Medical Center.
While about 2.2 million Americans have the disorder, the new device would only be available to a small group of patients who don’t respond to other treatments, such as antidepressant drugs and therapy.
The FDA approved the device under a program reserved for conditions that effect fewer than 4,000 people each year.
The FDA’s director for devices stressed that Reclaim provides some relief, but patients likely will have to continue taking medications as well.
“Reclaim is not a cure,” Dr. Daniel Schultz said in a statement. “Individual results will vary and patients implanted with the device are likely to continue to have some mild to moderate impairment.”
Shaped like a pacemaker, the Reclaim device is implanted under the skin of the chest and then connected to four electrodes in the brain. The electrodes deliver steady pulses of electricity that block abnormal brain signals.
Similar devices have been used since the 1990s to treat movement disorders like Parkinson’s disease and tremors. But where prior devices target areas of the brain that deal with movement, Medtronic said its product delivers electrical signals to areas that control mood and anxiety.
“What deep brain stimulation does is modulate those circuits that we believe are hyperactive in patients with obsessive compulsive disorder,” said Paul Stypulkowski, the company’s senior director of research.
Medtronic Inc., the world’s largest medical device maker, also is studying the use of the technology in patients with severe depression.
In 2005, rival Cyberonics became the first company to win FDA approval for a device to treat depression. However, the company’s Vagus Nerve Stimulator has been plagued by questions of effectiveness.
Members of Congress and consumer watchdog groups campaigned against the Cyberonics device, citing research that some patients who have received it had worsening depression. A number of insurers, including the government’s Medicare program, have refused to pay for the device in depression patients.
Medtronic representatives point out that their technology differs from that used by Houston-based Cyberonics, which delivers an electrical signal to nerves in the neck. Medtronic’s devices stimulate the brain directly.
Shares of Minneapolis-based Medtronic fell 20 cents to $34.13 Thursday.
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
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Amid nurse shortage, hospitals focus on retention
By RASHA MADKOUR
Associated Press Writer
MIAMI (AP) — Newly minted nurse Katie O’Bryan was determined to stay at her first job at least a year, even if she did leave the hospital every day wanting to quit.
She lasted nine months. The stress of trying to keep her patients from getting much worse as they waited, sometimes for 12 hours, in an overwhelmed Dallas emergency room was just too much. The breaking point came after paramedics brought in a child who’d had seizures. She was told he was stable and to check him in a few minutes, but O’Bryan decided not to wait. She found he had stopped breathing and was turning blue.
“If I hadn’t gone right away, he probably would have died,” O’Bryan said. “I couldn’t do it anymore.”
Many novice nurses like O’Bryan are thrown into hospitals with little direct supervision, quickly forced to juggle multiple patients and make critical decisions for the first time in their careers. About 1 in 5 newly licensed nurses quits within a year, according to one national study.
That turnover rate is a major contributor to the nation’s growing shortage of nurses. But there are expanding efforts to give new nursing grads better support. Many hospitals are trying to create safety nets with residency training programs.
“It really was, ‘Throw them out there and let them learn,’” said University of Portland nursing professor Diane Vines. The university now helps run a yearlong program for new nurses.
“This time around, we’re a little more humane in our treatment of first-year grads, knowing they might not stay if we don’t do better,” she said.
The national nursing shortage could reach 500,000 by 2025, as many nurses retire and the demand for nurses balloons with the aging of baby boomers, according to Peter Buerhaus of Vanderbilt University Medical Center. The nursing professor is author of a book about the future of the nursing work force.
Nursing schools have been unable to churn out graduates fast enough to keep up with the demand, which is why hospitals are trying harder to retain them.
Medical school grads get on-the-job training during formal residencies ranging from three to seven years. Many newly licensed nurses do not have a similar protected period as they build their skills and get used to a demanding environment.
Some hospitals have set up their own programs to help new nurses make the transition. Often, they assign novices to more experienced nurses, whom they shadow for a few weeks or months while they learn the ropes. That’s what O’Bryan’s hospital did, but for her, it wasn’t enough.
So more hospitals are investing in longer, more thorough residencies. These can cost roughly $5,000 per resident. But the cost of recruiting and training a replacement for a nurse who washed out is about $50,000, personnel experts estimate.
One national program is the Versant RN Residency, which was developed at Childrens Hospital Los Angeles and since 2004 has spread to 70 other hospitals nationwide. One of those, Baptist Health of South Florida in the Miami area, reports cutting its turnover rate from 22 percent to 10 percent in the 18 months since it started its program.
The Versant plan pairs new nurses with more experienced nurses and they share patients. At first, the veterans do the bulk of the work as the rookies watch; by the end of the 18-week training program, those roles are reversed.
The new nurses must complete a 60-item checklist. They must learn how to put in an IV line and urinary catheter; interpret different heart rhythms and know how to treat them; monitor patients on suicide watch and do hourly checkups on very critically ill patients; know how to do a head-to-toe physical assessment on a patient, as well as how to inform families about the condition of their loved one.
For Yaima Milian, who’s currently in the program at Baptist, this is markedly different from the preparation she got at her first hospital in New Jersey. She left after a six-week orientation because she didn’t feel ready to work solo.
While Milian was paired with a more experienced nurse at the New Jersey hospital, they didn’t see patients together; they split the workload. Her first week on the job, Milian was charged with caring for several patients with complicated issues — those on ventilators and with chest tubes — and she felt thoroughly unprepared.
“It just didn’t feel right, it felt very unsafe,” Milian said.
Besides the residency’s professional guidance, which includes classroom instruction, new nurses also get personal support from mentors — people they can call after a bad day or to get career advice. The new nurses also gather with their peers for regular debriefing, or “venting” sessions.
“Here you have this group that is pretty much experiencing the same things you’re experiencing,” Milian said, “and it makes you feel better.”
To be sure, not all the nurses who leave do so because of a rocky transition. But for nurses who do leave because of stress, these programs seem to help.
The American Association of Colleges of Nursing and the University HealthSystem Consortium teamed up in 2002 to create a residency primarily for hospitals affiliated with universities. Fifty-two sites now participate in that yearlong program and the average turnover rate for new nurses was about 6 percent in 2007.
“We believe all new graduates should be given this kind of support system,” said Polly Bednash, the nursing association’s executive director. “We are facing downstream a horrendous nursing shortage as a large number of nurses retire from the field… So you need to keep the people you get and keep them supported.”
The federal government has jumped on the bandwagon. Since 2003, it has awarded $17 million in grants for 75 hospitals to start first-year training programs.
The National Council of State Boards of Nursing is considering a standardized transition program. It cited a study showing a link between residencies and fewer medical errors, but also pointed to the inconsistency among current efforts.
That’s something O’Bryan, the Dallas nurse, knows about. Her hospital — which she declined to identify because she didn’t want to be seen as complaining about a former employer — had a three-month program, in which she attended weekly classes and was assigned a nurse to shadow. After that period was over, though, O’Bryan was abruptly alone, even as she continued to face new situations that she wasn’t sure how to handle.
“When things are going good and I’m not overwhelmed and I’m able to help people, I love it,” she said, recalling the gratification of seeing a bedridden patient finally manage to take a few steps.
“There are always those moments,” she said, “but they’re interrupted pretty quickly.”
The 27-year-old is currently looking for a new job. She’s not sure it will be in nursing.
___
American Association of Colleges of Nursing: http://www.aacn.nche.edu/
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
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Ruined financiers committing desperate acts
By DEBORAH HASTINGS
AP National Writer
In the abyss of financial ruin, faced with sure disgrace and possibly prison, some of the newly scandalized rich have taken desperate measures in these despairing times.
The black hole of hopelessness can be overwhelming. A man who lost $1.4 billion to Bernie Madoff sits down in his Manhattan office and carefully writes a series of suicide letters to family and friends, then swallows a fatal dose of pills and conscientiously places a wastebasket under his bleeding arm, after slicing it with a box cutter.
Others are mind-boggling in their brazenness. A financier accused of stealing from his investors boards his private plane alone, sends a fake distress call over Alabama saying his windshield has shattered and he is bleeding profusely, then parachutes from the still-moving Piper Malibu, which is later found in a Florida swamp with no signs of blood or an imploded windshield.
In the past year, there have been more than 10 such incidents, from points across the country and beyond, executed by men whose finances disintegrated, sometimes into greed and possible thievery — with the same dizzying speed of the roller-coaster global market.
In January alone, three cases surfaced. German billionaire investor Adolf Merckle, who lost a fortune in shorted Volkswagen stock, threw himself under a commuter train. Patrick Rocca, an Irish property investor who lost millions when the real estate market bottomed out, waited until his wife took their children to school before he shot himself in the head. Outside Chicago, real estate mogul Steven L. Good was found dead in his Jaguar, apparently from a self-inflicted gunshot wound.
“Suicide does not discriminate on the basis of social status,” said psychologist Alden Cass, who treats financial traders. “The ego of the successful person … is not used to failure, not used to being wrong. They’re perfectionists. They don’t allow for the gray in life. They don’t allow for second place. When that is taken away, they’re stripped of everything they know.”
Three days before Christmas, after writing his farewell notes, Rene-Thierry Magon de la Villehuchet killed himself in his 22nd-floor office in Midtown. He’d lost his entire savings, and his clients’ money, to Madoff’s alleged Ponzi scheme, which may have swallowed $50 billion from investments made by the very rich and the pension plans of everyday people.
The 65-year-old Frenchman, an aristocrat and professional investor, was deeply shamed and depressed, friends and family said. He felt he had ruined the lives of his clients, many of whom were friends. His brother, Bertrand, called his brother’s suicide an honorable act. “At first he thought he’d be able to get the money back,” Bertrand said in a Paris phone interview with The Associated Press after his brother’s death. “Gradually he realized he wouldn’t be able to. He trusted Madoff completely.”
The black dog of depression gnaws at these men. “They see no answers,” said Cass. “There is no hope. There is no way out.”
Running and hiding is an entirely different reaction. Those who fake their deaths are “people with sociopathic and narcissistic tendencies,” Cass says. “They believe they’re smarter than everyone else. They think they’re untouchable. They don’t believe they have to abide by the rules.”
In hindsight, Marcus Schrenker’s plan to disappear doesn’t appear particularly smart. The 38-year-old Indiana businessman, accused of betraying investors by not telling them about hundreds of thousands in fund fees — and facing a $533,000 legal judgment — bailed out of his plane, authorities say, two days after losing his court case.
Military jets were scrambled in response to his mayday call on Jan. 11. Pilots saw a dark cockpit and an open door before the small aircraft crashed near a residential area in Florida. The next day, Schrenker sent an e-mail to a friend, apologizing for the trouble he’d caused and saying he would be gone by the time the note was read.
But the only place Schrenker went was to jail. U.S. Marshals found him holed up in a Florida campground the following night. This time he was bleeding profusely; he’d slashed his wrist and was muttering the word “die.” His financial travails now include charges of deliberately crashing an aircraft and making a false distress call.
Convicted hedge fund scammer Sam Israel III, 49, lasted a month on the lam in an RV complete with motor scooter before surrendering to authorities.
Sentenced to 20 years in prison for defrauding investors of $450 million, Israel was supposedly driving himself to jail when he disappeared last June.
On the dusty hood of his SUV, which he parked on an upstate New York bridge 150 feet above the Hudson River, Israel had finger-painted “suicide is painless,” the title of television’s “M-A-S-H” theme song.
He didn’t jump. He got into a recreational vehicle driven by his girlfriend, who later admitted she trailed Israel on his aborted trip to prison and picked him up. He dropped her off at their home in Armonk, N.Y.
Then Israel grew a beard, and apparently rambled around a Massachusetts campground while police — who didn’t buy his vehicular postscript and arrested Ryan on charges of aiding and abetting — searched for him. His mother begged him to surrender.
On July 2, he puttered up to a Massachusetts police station on his scooter and gave himself up. Returned to New York, he stood before a furious judge, complaining of his bad back.
The judge ordered his $500,000 bail forfeited. He faces up to 10 additional years in prison for running.
“In their minds, all they have to do is erase the stigma and start over,” said M. Harvey Brenner, a public health professor emeritus at Johns Hopkins University in Baltimore. “It’s not easy to do. You have to have the constitution of a spy and live a double life.”
Brenner, who is more empathetic than psychologist Cass, says people like Israel “believe they can regain their reputation with new people. Then they can put the bad stuff behind them.”
Others might call them delusional. And there is little sympathy for those caught stealing from others in this nightmare recession, where already dismal unemployment rates jumped last week to 7.6 percent, reflecting the biggest loss of jobs since December 1974.
Web sites are rife with disdain. “These guys do not deserve any sympathy. Instead of taking their punches like a man they wimped out and took the easy way out. Some of them lost their money out of simple greed and did not want to face the consequences,” reads one of the printable Internet comments, this one posted at Conde Nast’s Portfolio.com.
“Most people don’t earn anywhere near what these people earn,” said Brenner. And it goes against the basis of the American work ethic. “You work hard, with the same principles and ethics your parents did. You try to lead an honorable life.”
Disgraced or desperate fatcats have a long history in this country. Public lore has stockbrokers falling like rain after the 1929 stock market crash — though the prevalence of such suicides has long been argued.
But Winston Churchill, visiting New York City at the time, wrote of awakening the day after Black Tuesday to a noisy crowd outside the Savoy-Plaza Hotel. “Under my very window a gentleman cast himself down fifteen storeys and was dashed to pieces, causing a wild commotion and the arrival of the fire brigade.”
In 1933, as the Great Depression peaked, and 25 percent of the work force had no jobs, the suicide rate of Americans rose from 14 to 17 per 100,000 — the highest in history.
Wall Street trader Jesse Livermore was nicknamed “Boy Wonder” for his outrageous market antics. In 1907, he made $3 million by short-selling the market as it crashed. In 1929, he made $100 million doing the same thing. He o wned a series of mansions around the world, each with a full, permanent staff, and possessed a steel-hulled ship for overseas trips.
Livermore told anyone who’d listen to follow his Wall Street strategy: increase your position as the market moves in your direction, and quickly cut your losses. But he often failed to heed his own advice. He lost two fortunes, accumulated a third, and lost that, too. In 1940, in the bar of the Sherry-Netherland Hotel in New York City, he shot himself to death, leaving $365,000 in debts and a rambling, 8-page suicide note to his second wife. “I am a failure. I am a failure. I am a failure,” it said.
But it’s not just reckless speculators who may be left feeling emotionally bankrupted.
Robert Chew, a writer and consultant, invested $1.2 million with Stanley Chais, a longtime Beverly Hills, Calif., philanthropist. Chais, in turn, invested with Madoff.
But Chew and wife Sarah had never heard of Madoff until a call came to their Colorado home in December, telling them they’d lost all their invested money.
Looking back, Chew says he knew it should have been too good to be true — high returns on secretive funds that continually did well. But he and his wife had watched her family members do well for decades with Chais. “We thought this guy was a genius,” he said.
Chais has said he, too, was duped.
With no retirement money, the Chews struggle to find a reason to believe life will get better.
“You look around and you wonder what more is there to my life? My life is over,” Robert Chew says. “I’m 56. Will I be able to find another job? Or will we be out in the street?”
For now, Chew is writing columns about the financial crisis for Time magazine. His first, titled “How I Got Screwed by Bernie Madoff,” ran in December.
“We all knew it was a risk, we were told to make sure we were diversified, blah blah, but my God, it had been going strong for so long and with such fantastic returns, we had to get in,” he wrote. “We deluded ourselves into thinking we were smarter than the others.”
Now, he knows very little about today or the future.
“We don’t know what we’re going to do,” he says. “We find ourselves at night, with the lights out, crying, asking, ‘What are we going to do?’”
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
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Iowa agency: Housing for disabled men was criminal
By NIGEL DUARA
Associated Press Writer
IOWA CITY, Iowa (AP) — An Iowa state agency said Tuesday it intends to file criminal charges against the party responsible for lodging 21 mentally disabled factory workers in an unsafe, poorly heated building.
The state Department of Inspections and Appeals would file charges of operating a health care facility without a license, but it’s unclear who can be charged, said agency spokesman Dave Werning.
“We’re pursuing criminal charges,” he said. “But the suspects have yet to be determined.”
The state got a tip last week that the 21 men were working at West Liberty Foods, a meatpacking plant that hired laborers through a Texas-based company called Henry’s Turkey Service. The men are believed to be from Texas.
State officials said the men were housed in a 106-year-old, boarded-up building with space heaters. Most of them apparently have worked at West Liberty for 20 years or longer.
Werning said Tuesday that “a box of documentation” seized during a raid at the building will be analyzed to determine whether the workers were financially exploited.
“We’re looking to see what happened to their money, what happened to their taxes,” he said.
Representatives of Henry’s Turkey Service and West Liberty did not immediately respond to calls seeking comment.
Criminal charges would be based on a determination by the state that the men are dependent adults and need care. Charges of operating a health care facility without a license can be brought when three or more dependent adults are living in one residence that’s not licensed.
The men were taken Tuesday to residential-care facilities in Waterloo operated by Exceptional Persons Inc., a nonprofit that works with mentally disabled people.
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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3rd Service Member Electrocuted in Shower in Iraq
By KIMBERLY HEFLING
Associated Press Writer
WASHINGTON (AP) — A third U.S. service member has been determined to have been electrocuted in a shower in Iraq, and Navy criminal investigators are investigating, The Associated Press has learned.
Navy Petty Officer 3rd Class David A. Cedergren, 25, of South St. Paul, Minn., died Sept. 11, 2004, while showering. His family was told he died of natural causes.
Late last year, the Armed Forces Institute of Pathology changed the manner of Cedergren’s death to “accidental,” caused by electrocution and inflammation of the heart. The Naval Criminal Investigative Service has reopened an investigation into his death, Ed Buice, a NCIS spokesman, said Monday.
Cedergren’s death is among 18 electrocution deaths — 16 U.S. service members and two military contractors — under review as part of a Department of Defense Inspector General inquiry. Improperly installed or maintained electrical devices have been blamed in some of the deaths, while accidental contact with power lines caused others.
The inquiry primarily involves electrical work done at a facility where a Green Beret, Staff Sgt. Ryan Maseth, 24, of Pittsburgh, was electrocuted while showering in January 2008.
Cedergren — a medic — was found in an outdoor shower stall in Camp Iskandariyah, Iraq, not breathing and without a pulse.
His brother, Barry Cedergren, said his family initially suspected he’d been shocked because, according to reports shown to the family, witnesses told investigators that some service members had reported being shocked in the shower.
He said military investigators took a second look at the case after a request from former Sen. Norm Coleman, R.-Minn.
“We’re looking further into what our options are,” said Barry Cedergren, of Ramsey, Minn.
Maseth’s death was initially considered accidental, but is now classified by Army investigators as “negligent homicide” caused by Houston-based contractor KBR Inc. and two of its supervisors. An Army investigator said the contractor failed to ensure that “qualified electricians and plumbers” did the work. The case is under legal review.
Last year, Maseth’s family sued KBR in Allegheny County, Pa., alleging wrongful death. The case was moved to federal court in western Pennsylvania, where it is pending.
NCIS spokesman Buice said he could not comment on evidentiary issues such as who was maintaining the shower where David Cedergren died.
Another service member electrocuted in Iraq while showering in a U.S.-maintained facility was identified in a congressional report as Army Cpl. Marcos Nolasco, 34, of Chino, Calif. Investigators concluded he was electrocuted when an ungrounded water heater shorted, the report said.
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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