Consumer Safety Agency Studies Adult Bedrail Deaths

WASHINGTON — The Consumer Product Safety Commission on Thursday released a review of bedrail deaths and injuries of adults as it considered how to address potential hazards associated with the products.

Using data from death certificates and hospital emergency room visits, the report cited 155 deaths involving bedrails from January 2003 to this past September. About 126 of those who died were 60 or older.

Sixty-one percent of the bedrail deaths occurred at home. About a quarter occurred at a nursing home or an assisted living facility, the report said.

It also found that nearly half of those who died in bedrail accidents had medical problems — dementia, heart disease and Parkinson's disease among them. Most of the 155 deaths occurred when a person became stuck in the bedrails, mainly with his or her head or neck getting caught.

Almost 37,000 people were injured in bedrail accidents and treated at hospital emergency rooms from 2003 through 2011, the agency said. Data for 2012 was not yet available.

Consumer safety advocates, who have long campaigned for federal regulators to study bedrail deaths and injuries, called the report an important first step. But they said that it failed to address several issues, including jurisdictional matters concerning which agency has responsibility for some types of bedrails: the Consumer Product Safety Commission or the Food and Drug Administration.

The advocates said that the question of oversight remained one of the biggest problems with bedrails, because there are unanswered technical questions about which rails are medical devices and which are consumer products.

The report did not review bedrail designs for potential problems. The consumer agency has pointed out that the makers of bedrails are usually not identified on death certificates or doctors' notes.

The safety agency said it would use the findings to study what steps it should take next, including how it can educate caregivers and the public about potential hazards.

It said it had forwarded its findings to the Food and Drug Administration. The F.D.A. did not respond to requests for comment.

In response to a lack of coordination between federal regulators, Representative Edward J. Markey, Democrat of Massachusetts, called for the consumer and drug agencies, as well as the Federal Trade Commission, to form a task force to address the regulation of bedrails and bed systems, specifically rails that blur the line between being medical devices and consumer products.

"We need a national task force dedicated to addressing any regulatory gaps and protecting these vulnerable patients from preventable bedrail injuries," Mr. Markey said in a statement.

Giselle Barry, a spokeswoman for Mr. Markey, said the congressman would send a formal letter to the agencies on Friday calling for the task force.

13.57 | 0 komentar | Read More

In Study, Fears That Life Insurers Are Courting Reserve Risk

WASHINGTON — After more than a year studying a surge of intricate financial deals in the life insurance industry, regulators said Thursday that they had found transactions that could "give the industry a black eye," but could not agree on what to do about them.

"There are some transactions out there that we're not comfortable with, and we're not sure you'd be comfortable with," Douglas Slape, chairman of the research panel, told a ballroom full of industry representatives at a conference in suburban Washington. "We can't go into the details because it's confidential."

Differences among the panelists soon became apparent as the group laid out its findings. Some expressed concern that insurers were "betting the policyholders' money," while others argued that the transactions were carefully vetted and safe.

The National Association of Insurance Commissioners convened the research project, in part, in response to an article in The New York Times on the growing practice among life insurers of offloading huge numbers of policies into opaque, off-balance-sheet subsidiaries. The transactions, often valued in the hundreds of millions or even billions of dollars, can improve the appearance of the insurers' balance sheets and free up money for other projects, or to pay shareholder dividends.

The Times article questioned whether the use of the special-purpose vehicles meant a shadow insurance industry was being created, outside the usual reach of state insurance regulators.

Diverging views among Thursday's panel of state regulators pose a problem because the transactions often involve an insurer in one state, a subsidiary in another, and policies sold to customers in any number of other states. States, rather than the federal government, are the primary regulators of the nation's insurance companies.

"Our entire financial solvency system falls apart if there is not uniformity" among state regulators, said Joseph Torti, a panelist from Rhode Island. "We need to be able to understand what our sister states are doing."

Separately, New York State is conducting its own investigation of the off-balance-sheet insurance deals. This year it called on the insurers under its jurisdiction to provide detailed information about their special-purpose subsidiaries, why they had created them, and whether the subsidiaries were counting assets that the insurer itself would not be allowed to include on its balance sheet.

In recent years, some states passed laws allowing insurance companies to set up the subsidiaries, because they were perceived as creating good jobs.

Conventional state insurance regulation protects policyholders by requiring companies to set aside enough of the premium money they take in to build reserves to pay all future claims. Companies are also required to maintain a healthy surplus, and regulators can make them stop selling new policies if they fall too far short.

When the life insurers secure their policies through special-purpose vehicles, however, they can do so without building up a body of liquid, cashlike reserves, as prescribed by regulators.

Instead, they offer some form of collateral, like a letter of credit, to stand behind the policies. Some regulators said there were cases in which the collateral was inadequate and would not have been admitted under the usual regulatory standards.

Data compiled by SNL Financial, a data and news company, shows that the practice of securing life policies through a wholly owned subsidiary has grown sharply in the last five years. In 2006, the companies SNL surveyed used such subsidiaries for 31 percent of the policies they reinsured; by 2011, it was up to 45 percent.

SNL also found that while the practice was very popular at some companies, others did not use it at all. The American International Group used subsidiaries for nearly 80 percent of the life policies that it reinsured in 2011, for instance, while Northwestern Mutual used only unaffiliated reinsurers, where the terms would be set in an arms' length transaction. Still others, like State Farm, were not reinsuring their life policies as of 2011.

13.57 | 0 komentar | Read More

Ranbaxy, a Generic Drug Maker, Stops Making Cholesterol Pill

Ranbaxy Pharmaceuticals, the largest producer of the generic version of Lipitor, has halted production of the drug until it can figure out why glass particles may have ended up in pills that were distributed to the public, the Food and Drug Administration announced Thursday.

The agency said it had not received any reports of patients being harmed by the particles, which are about the size of a grain of sand. Earlier this month, Ranbaxy recalled more than 40 lots of the drug because of the glass contamination.

The company has declined to say where the drug was manufactured or why the problem occurred, but a spokeswoman for the F.D.A. said Thursday that the company would stop making the pill's active ingredient, which is made in India, until the investigation is completed.

The contamination was the latest episode in a history of manufacturing lapses at Ranbaxy, which is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo. The company has been operating under a court-ordered consent decree since January, one that federal authorities have called "unprecedented in scope," after they identified a host of manufacturing problems at the company's plants in India and the United States, and concluded that Ranbaxy had submitted false data in drug applications to the F.D.A..

The decree prevents Ranbaxy from manufacturing drugs at its most troubled facilities until it can show it is meeting United States standards, although it was allowed to continue making products — including the generic version of Lipitor — at other plants.

The F.D.A. spokeswoman, Sarah Clark-Lynn, said the affected lots were not made at "the same facilities whose conduct gave rise to the consent decree." Nonetheless, she said in an e-mail Monday, "the consent decree provides the F.D.A. with additional tools to address violations for other Ranbaxy facilities."

A spokesman for Ranbaxy declined to comment beyond an informational statement on the company's Web site.

Some drug manufacturing experts said Ranbaxy's latest troubles highlight the disparities in oversight of plants in the United States versus those overseas. "I have pretty good faith in companies and plants that make drugs in this country because I know from my own experience that they try to do a good job," said Prabir K. Basu, executive director of the National Institute for Pharmaceutical Technology and Education, who previously worked in manufacturing and global outsourcing for pharmaceutical companies, including Searle and Pharmacia. "But my confidence is not that high when we are getting products from outside the country."

He pointed to studies that have shown the F.D.A. inspects foreign generic manufacturing plants about once every seven to 13 years, compared with once every two years for domestic manufacturers. A law passed over the summer will eventually require the F.D.A. to apply the same standards when inspecting all manufacturing plants, regardless of which country they're in.

Allan Coukell, director of medical programs at the Pew Health Group and an expert on drug safety, said the new law would level what he described as an uneven playing field, but "it's incumbent on F.D.A. to hire the staff and to make the shift to a risk-based inspection system." Under the law, fees collected from generic manufacturers will help pay for more inspectors.

Mr. Basu said the law, called the Generic Drug User Fee Amendments of 2012 and known as Gdufa (Gah-doofuh) was a step in the right direction, but fixing the problem would require more than simply hiring more people. "This is a very difficult and complex system, and how do we ensure the integrity of this supply chain?" he said. "I don't know how much Gdufa will help."

Ranbaxy has held a significant share of the market for generic Lipitor, also known as atorvastatin, since it became one of the first companies to sell it after Pfizer lost patent protection for the top-selling drug last November; another company, Watson, sold a generic version that was authorized and manufactured by Pfizer. In October, Ranbaxy's product accounted for 43 percent of prescriptions for atorvastatin, a widely used drug to lower cholesterol levels, according to an analysis by Michael Faerm, an analyst for Credit Suisse who used prescription data from the research firm IMS Health.

In its statement on Thursday, the F.D.A. said it did not expect a shortage of atorvastatin. Erin Fox, who tracks drug shortages as director of the Drug Information Service at the University of Utah, said drugs in pill form have long shelf lives and suppliers can keep large quantities in stock. Other generic manufacturers with approval to sell the drug include Apotex, Dr. Reddy's Labs, Mylan, Sandoz, and Teva, according to the F.D.A. Web site.

Ranbaxy has posted a list of the recalled lots on its Web site, and has warned that patients should not stop taking the drug without guidance from their doctor. The lot numbers are found on the side of Ranbaxy pill bottles and the company advised patients to check with their pharmacist if customers received pills in a container dispensed by the pharmacy.

The agency said the potential for injury because of the contamination appeared to be low and "if any adverse events are experienced, they would be temporary."

13.57 | 0 komentar | Read More

Hockey Coaches Defy Doctors on Concussions, Study Finds

Despite several years of intensive research, coverage and discussion about the dangers of concussions, the idea of playing through head injuries is so deeply rooted in hockey culture that two university teams kept concussed players on the ice even though they were taking part in a major concussion study.

The study, which will be published Friday in a series of articles in the journal Neurosurgical Focus, was conducted during the 2011-12 hockey season by researchers from the University of Western Ontario, the University of Montreal, Harvard and other institutions.

"This culture is entrenched at all levels of hockey, from peewee to university," said Dr. Paul S. Echlin, a concussion specialist and researcher in Burlington, Ontario, and the lead author of the study. "Concussion is a significant public health issue that requires a generational shift. As with smoking or seat belts, it doesn't just happen overnight — it takes a massive effort and collective movement."

The study is believed to be among the most comprehensive analyses of concussions in hockey, which has a rate of head trauma approaching that of football. Researchers followed two Canadian university teams — a men's team and a women's team — and scanned every player's brain before and after the season. Players who sustained head injuries also received scans at three intervals after the injuries, with researchers using advanced magnetic resonance imaging techniques.

The teams were not named in the study, in which an independent specialist physician was present at each game and was empowered to pull any player off the ice for examination if a potential concussion was observed.

The men's team, with 25 players and an average age of 22, played a 28-game regular season and a 3-game postseason. The women's team, with 20 players and an average age of 20, played 24 regular-season games and no playoff games. Over the course of the season, there were five observed or self-reported concussions on the men's team and six on the women's team.

Researchers noted several instances of coaches, trainers and players avoiding examinations, ignoring medical advice or otherwise obstructing the study, even though the players had signed consent forms to participate and university ethics officials had given institutional consent.

"Unless something is broken, I want them out playing," one coach said, according to the study.

In one incident, a neurologist observing the men's team pulled a defenseman during the first period of a game after the player took two hits and was skating slowly. During the intermission the player reported dizziness and was advised to sit out, but the coach suggested he play the second period and "skate it off." The defenseman stumbled through the rest of the game.

"At the end of the third period, I spoke with the player and the trainer and said that he should not play until he was formally evaluated and underwent the formal return-to-play protocol," the neurologist said, as reported in the study. "I was dismayed to see that he played the next evening."

After the team returned from its trip, the neurologist questioned the trainer about overruling his advice and placing the defenseman at risk.

"The trainer responded that he and the player did not understand the decision and that most of the team did not trust the neurologist," according to the study. "He requested that the physician no longer be used to cover any more games."

In another episode, a physician observer assessed a minor concussion in a female player and recommended that she miss the next night's game. Even though the coach's own playing career had ended because of concussions, she overrode the medical advice and inserted the player the next evening.

According to the report, the coach refused to speak to another physician observer on the second evening. The trainer was reluctant to press the issue with the coach because, the trainer said, the coach did not want the study to interfere with the team.

"Interesting gap between theory and practice," one of the study's physicians said in the report. "The athlete's and coach's decision to return to play the next day despite incurring a minor concussion reflects what occurs thousands of times every day."

After this second instance of a coach overriding medical advice following a concussion diagnosis, the researchers talked to the coaches about the serious long-term threat their actions posed to their players' health. By the end of the study, the teams' cooperation improved markedly.

A similar study by Echlin's research team followed two Canadian junior hockey teams, with male players ages 16 to 20, for the 2009-10 season. In that study, independent specialists examined players immediately after on-ice collisions and were able to recommend they be held out of games. Coaches and trainers resisted that study as well, and one of the two junior teams dropped out during the season.

That study found concussion rates seven times higher than previously reported. In the study to be published Friday, the male players sustained concussions at three times the rate reported in most previous studies, and the female players at five times the rate reported in most studies. The women also sustained concussions almost twice as frequently as the men, despite rules in women's hockey designed to curb body checking. The brain scans taken after the season also showed substantive metabolic changes among the majority of players, including those who were not diagnosed with concussions. Researchers said the changes in the brains might be evidence of trauma caused by subconcussive blows.

"You may not need to have a diagnosed concussion to actually have changes in your white matter," said Dr. Inga K. Koerte, a researcher in the study. "It may be that subconcussive blows to your head accumulate over time, so that you develop changes that are similar to when you have one clinical concussion."

Koerte, of Brigham and Women's Hospital in Boston, Harvard and the University of Munich, stressed that the finding in this area was preliminary and required further research.

Echlin said that dismissive attitudes toward head trauma persisted in hockey at all levels, despite the widespread attention on Sidney Crosby's drawn-out recovery from concussion symptoms in 2011 and 2012.

"This is our national game which we all love," Echlin wrote, "and it is time to consider a cultural shift to address the prevention and treatment of this serious brain injury that is occurring at epidemic proportions."

13.57 | 0 komentar | Read More

Phys Ed: Keeping Your Eye on the Ball

Recently, researchers in England set out to determine whether weekend golfers could improve their game through one of two approaches. Some were coached on individual swing technique, while others were instructed to gaze fixedly at the ball before putting. The researchers hoped to learn not only whether looking at the ball affects performance, but also whether where we look changes how we think and feel while in action.

Phys Ed

Gretchen Reynolds on the science of fitness.

Back in elementary school gym class, virtually all of us were taught to keep our eyes on the ball during sports. But a growing body of research suggests that, as adults, most of us have forgotten how to do this. When scientists in recent years have attached sophisticated, miniature gaze-tracking devices to the heads of golfers, soccer players, basketball free throw shooters, tennis players and even competitive sharpshooters, they have found that a majority are not actually looking where they believe they are looking or for as long as they think.

It has been less clear, though, whether a slightly wandering gaze really matters that much to those of us who are decidedly recreational athletes.

Which is in part why the British researchers had half of their group of 40 duffers practice putting technique, while the other half received instruction in a gaze-focusing technique known as "Quiet Eye" training.

Quiet Eye training, as the name suggests, is an attempt to get people to stop flicking their focus around so much. But "Quiet Eye training is not just about looking at the ball," says Mark Wilson, who led the study, published in Psychophysiology, and is a senior lecturer in human movement science at the University of Exeter in England. "It is about looking at the ball for long enough to process aiming information." It involves reminding players to first briefly sight toward the exact spot where they wish to send the ball, and then settle their eyes onto the ball and hold them there.

This tight focus on the ball, Dr. Wilson says, blunts distracting mental chatter and allows the brain "to process the aiming information you just gathered" and direct the body in the proper motions to get the ball where you wish it to go.

A quiet, focused eye, in other words, seems to encourage a quiet, focused mind, which then makes for more accurate putting.

And in fact, after Dr. Wilson had his golfing volunteers practice for hours on either specific aspects of stroke technique or on focusing their gaze and not worrying about technique, those who had worked on their gaze were more accurate than those who had fine-tuned their technique. Those trained to focus also had lower heart rates and less muscle twitchiness, indicating less performance anxiety.

Similar results have been reported among soccer penalty kickers, who, like golfers, need to precisely place a ball but have the added distraction of a peripatetic, obstructive goalie. Many players tend to glance at the goalie as they prepare to shoot. Their eyes are not quiet, and their aim is affected.

But in a study published last year in the journal Cognitive Processing, collegiate players who were instructed to look briefly toward one of the upper, far corners of the goal and then immediately back to the ball, ignoring the goalie, significantly improved their shooting accuracy and reduced by 50 percent the number of times the goalie blocked their try, compared to teammates who didn't quiet their gaze.

It did not seem to matter, says Greg Wood, also of the University of Exeter, who led the study, that kickers were glancing briefly toward where they planned to shoot, potentially telegraphing their intentions to the goalie. "An accurate shot kicked with typical speed will reach the goal in approximately 400 milliseconds, leaving the goalie with insufficient processing and response time," he says. Players needn't disguise intent if their aim is true.

Of course, merely keeping your eye on the ball won't induce it to roll or rise to the desired location if you employ miserable technique. No amount of laser-eyed focus will get one of my putts to land. But what is interesting about Quiet Eye-style training, Dr. Wilson says, is that it can allow recreational and novice athletes with rudimentary skills to progress rapidly.

Specifically, Dr. Wilson says, after having extensively studied just how the best golfers look, he now teaches novice golfers at his lab to "keep their gaze on the back of the ball, which is the contact point for the putter, for a brief period before starting the putting action" — long enough to, for instance, "say 'back of the cup' to themselves," he says. The golfers are told to hold that position throughout the putting stroke and, he says, "importantly, after contact for a split second. I often ask golfers to rate the quality of their contact on the ball from 1 to 10, before they look up to see where the ball went."

Inexperienced putters who followed these instructions improved much more rapidly, he says, than those who merely practiced putts repeatedly.

"It seems so obvious," Dr. Wilson says. "It is almost too simple. People assume that they are doing all of this already. 'You mean I should look at the ball?' Duh!"

But, he concludes, "the fact is that many people do not look at the right place at the right time."

13.57 | 0 komentar | Read More

Hypothermia and Carbon Monoxide Poisoning Cases Soar in New York After Hurricane Sandy

The number of cold-exposure cases in New York City tripled in the weeks after Hurricane Sandy struck compared with the same period in previous years, the health department reported in an alert to thousands of doctors and other health care providers on Wednesday.

And even though power and heat have been restored to most of the city, there are still thousands of people living in the cold, the department said.

The department warned health care providers that residents living in unheated homes faced "a significant risk of serious illness and death from multiple causes."

The number of cases of carbon monoxide exposure, which can be fatal, was more than 10 times as high as expected the week of the storm and 6 times as high the next week, reflected in greater numbers of emergency department visits. Calls to the city's poison center also increased, health officials said.

And as temperatures dip, health officials said the cold could lead to other health problems, including a worsening of heart and lung diseases and an increase in anxiety and depression.

"My bigger concern is what happens in the future as we get closer to winter in the next four weeks," Dr. Thomas A. Farley, the city's health commissioner, said in an interview. "There are probably about 12,000 people living in unheated apartments right now."

Between Nov. 3 and 21, more than three times as many people visited emergency rooms for cold exposure as appeared during the same time periods from 2008 to 2011, the health department said. The storm hit on Oct. 29.

It took days before many elderly and disabled residents, trapped in cold, dark apartments without working elevators or phones, were visited by emergency responders and health workers. Some went to emergency rooms.

Dr. Farley said prolonged exposure to cold even slightly below room temperature could be deadly, and he urged residents of unheated apartments to consider relocating. He said they could find help by calling 311.

The alert said residents in cold apartments should wear layers of dry, loosefitting clothing. They should not use ovens or portable gas heaters because of the risks of fire and carbon monoxide.

The statistics were collected through a system that gathers major complaints daily from most of the city's hospital emergency departments. The number of hypothermia cases reported to the system since the storm is 65, but that is considered an undercount.

Health department officials said the figure also did not reflect the much larger number of people whose underlying heart and lung problems had worsened in cold environments. An increase in asthma attacks, heart attacks and stroke would be more difficult to detect immediately. Officials said both the very young and older people, as well as people with chronic diseases, mental illness and substance use, were most at risk.

Dr. Farley said the increase in hypothermia cases was greatest immediately after the hurricane and during the cold period around the northeaster on Nov. 7.

Some people exposed to cold were treated at Staten Island University Hospital. "Our initial cases were people immersed in water, most in the process of being rescued," said Dr. Brahim Ardolic, chairman of the hospital's department of emergency medicine.

Makeshift efforts to keep warm also caused health problems. Many city residents without heat used stoves and, in some cases, generators indoors or in garages, leading to exposure to carbon monoxide, a colorless, odorless gas.

"It's a really scary exposure because you usually don't realize what happened," Dr. Ardolic said. "It can be insidious enough that you can go to sleep and wake up, if you're lucky, with a severe headache. If you're unlucky, you just won't wake up."

One post-storm patient was Hazel Mintz, 90, who lives on the 12th floor of an apartment building in Far Rockaway, Queens, that lost heat. She was taken to the emergency room after the storm because of chest pain. Days later, after neighbors heard a carbon monoxide alarm and smelled something burning in Ms. Mintz's empty apartment, a caregiver opened the door to find a blackened kettle atop a burner with a gas flame. "I put on the gas to warm up," Ms. Mintz, who has recovered, said.

At St. John's Episcopal Hospital in Far Rockaway, one of the areas hardest hit by the storm, 13 people have been treated for carbon monoxide exposure since the storm, including a family of three burning charcoal indoors to keep warm, said Dr. Rajiv Prasad, the emergency department director.

13.57 | 0 komentar | Read More

Medicare Is Faulted in Electronic Medical Records Conversion

The conversion to electronic medical records — a critical piece of the Obama administration's plan for health care reform — is "vulnerable" to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators.

Mike Spencer/Wilmington Star-News, via Associated Press

Celeste Stephens, a nurse, leads a session on electronic records at New Hanover Regional Medical Center in Wilmington, N.C.

Centers for Medicare and Medicaid Services

Marilyn Tavenner, acting administrator for Medicare.

The use of electronic medical records has been central to the aim of overhauling health care in America. Advocates contend that electronic records systems will improve patient care and lower costs through better coordination of medical services, and the Obama administration is spending billions of dollars to encourage doctors and hospitals to switch to electronic records to track patient care.

But the report says Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions.

Medicare "faces obstacles" in overseeing the electronic records incentive program "that leave the program vulnerable to paying incentives to professionals and hospitals that do not fully meet the meaningful use requirements," the investigators concluded. The report was prepared by the Office of Inspector General for the Department of Health and Human Services, which oversees Medicare.

The investigators contrasted the looser management of the incentive program with the agency's pledge to more closely monitor Medicare payments of medical claims. Medicare officials have indicated that the agency intends to move away from a "pay and chase" model, in which it tried to get back any money it has paid in error, to one in which it focuses on trying to avoid making unjustified payments in the first place.

Late Wednesday, a Medicare spokesman said in a statement: "Protecting taxpayer dollars is our top priority and we have implemented aggressive procedures to hold providers accountable. Making a false claim is a serious offense with serious consequences and we believe the overwhelming majority of doctors and hospitals take seriously their responsibility to honestly report their performance."

The government's investment in electronic records was authorized under the broader stimulus package passed in 2009. Medicare expects to spend nearly $7 billion over five years as a way of inducing doctors and hospitals to adopt and use electronic records. So far, the report said, the agency has paid 74, 317 health professionals and 1,333 hospitals. By attesting that they meet the criteria established under the program, a doctor can receive as much as $44,000 for adopting electronic records, while a hospital could be paid as much as $2 million in the first year of its adoption. The inspector general's report follows earlier concerns among regulators and others over whether doctors and hospitals are using electronic records inappropriately to charge more for services, as reported by The New York Times last September, and is likely to fuel the debate over the government's efforts to promote electronic records. Critics say the push for electronic records may be resulting in higher Medicare spending with little in the way of improvement in patients' health. Thursday's report did not address patient care.

Even those within the industry say the speed with which systems are being developed and adopted by hospitals and doctors has led to a lack of clarity over how the records should be used and concerns about their overall accuracy.

"We've gone from the horse and buggy to the Model T, and we don't know the rules of the road. Now we've had a big car pileup," said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago. The association, which contends more study is needed to determine whether hospitals and doctors actually are abusing electronic records to increase their payments, says it supports more clarity.

Although there is little disagreement over the potential benefits of electronic records in reducing duplicative tests and avoiding medical errors, critics increasingly argue that the federal government has not devoted enough time or resources to making certain the money it is investing is being well spent.

House Republicans echoed these concerns in early October in a letter to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. "The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments," said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.

In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it "would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff." She said Medicare was trying to determine whether electronic records had been used in any fraudulent billing but she insisted that the current efforts to certify the systems and address the concerns raised by the Republicans and others were adequate.

13.57 | 0 komentar | Read More

Cost of Brand-Name Prescription Medicines Soaring

The price of brand-name prescription medicines is rising far faster than the inflation rate, while the price of generic drugs has plummeted, creating the largest gap so far between the two, according to a report published Wednesday by the pharmacy benefits manager Express Scripts.

The report tracked an index of commonly used drugs and found that the price of brand-name medicines increased more than 13 percent from September 2011 to this September, which it said was more than six times the overall price inflation of consumer goods. Generic drug prices dipped by nearly 22 percent.

The drop in the price of generics "represents low-hanging fruit for the country to save money on health care," said Dr. Steve Miller, the chief medical officer of Express Scripts, which manages the drug benefits for employers and insurers and also runs a mail-order pharmacy.

The report was based on a random sample of six million Express Scripts members with prescription drug coverage.

The Pharmaceutical Research and Manufacturers of America, the trade group representing brand-name manufacturers, criticized the report, saying it was skewed by a handful of high-priced specialty drugs that are used by a small number of patients and overlooked the crucial role of major drug makers.

"Without the development of new medicines by innovator companies, there would be neither the new treatments essential to progress against diseases nor generic copies," Josephine Martin, executive vice president of the group, said in a statement.

The report cited the growth of specialty drugs, which treat diseases like cancer and multiple sclerosis, as a major reason for the increase in spending on branded drugs. Spending on specialty medicines increased nearly 23 percent during the first three quarters of 2012, compared with the same period in 2011. All but one of the new medicines approved in the third quarter of this year were specialty drugs, the report found, and many of them were approved to treat advanced cancers only when other drugs had failed.

Stephen W. Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota, said the potential benefits of many new drugs did not always match the lofty price tags. "Increasingly it's going to be difficult for drug-benefit programs to make decisions about coverage and payment and which drugs to include," said Mr. Schondelmeyer, who conducts a similar price report for AARP. He also helps manage the drug benefit program for the University of Minnesota.

"We're going to be faced with the issue that any drug at any price will not be sustainable."

Spending on traditional medicines — which treat common ailments like high cholesterol and blood pressure — actually declined by 0.6 percent during the period, the report found. That decline was mainly because of the patent expiration of several blockbuster drugs, like Lipitor and Plavix, which opened the market for generic competitors. But even as the entry of generic alternatives pushed down spending, drug companies continued to raise prices on their branded products, in part to squeeze as much revenue as possible out of an ever-shrinking portfolio, Dr. Miller said.

Drug makers are also being pushed by from companies like Express Scripts and health insurers, which are increasingly looking for ways to cut costs, said C. Anthony Butler, a pharmaceuticals analyst at Barclays. "I think they're pricing where they can but what they keep telling me is they're under significant pressure" to keep prices low, he said.

Express Scripts earns higher profits from greater use of generic medicines than brand name drugs sold through their mail-order pharmacy, Mr. Butler said. "There's no question that they would love for everybody to be on a generic," he said.

Dr. Miller acknowledged that was true but said that ultimately, everyone wins. "When we save people money, that's when we make money," he said. "We don't shy away from that."

13.57 | 0 komentar | Read More

Tobacco Companies Are Told to Correct Lies About Smoking

WASHINGTON (AP) — A federal judge on Tuesday ordered tobacco companies to publish corrective statements that say they had lied about the dangers of smoking and that disclose smoking's health effects, including the death on average of 1,200 people a day.

The judge, Gladys Kessler of United States District Court for the District of Columbia, previously said she wanted the industry to pay for corrective statements in various types of advertisements. But Tuesday's ruling is the first time she laid out what the statements will say.

Each corrective ad is to be prefaced by a statement that a federal court has concluded that the defendant tobacco companies "deliberately deceived the American public about the health effects of smoking." The corrective statements are part of a case the government brought in 1999.

Judge Kessler ruled in that case in 2006 that the nation's largest cigarette makers had concealed the dangers of smoking for decades, and said she wanted the industry to pay for "corrective statements" in various types of ads.

The Justice Department proposed corrective statements, which Judge Kessler used as the basis for some of the ones she ordered Tuesday.

Tobacco companies had urged Judge Kessler to reject the government's proposed industry-financed corrective statements; the companies called them "forced public confessions." Judge Kessler wrote that all of the corrective statements were based on specific findings of fact made by the court.

"This court made a number of explicit findings that the tobacco companies perpetuated fraud and deceived the public regarding the addictiveness of cigarettes and nicotine," she said.

13.57 | 0 komentar | Read More

Nurses Sue Douglas Kennedy for $200,000

Yana Paskova for The New York Times

Two nurses have accused Douglas Kennedy, a son of Robert F. Kennedy, of assault and battery, negligence and causing them emotional and physical distress after an episode involving his newborn son.

Connect with NYTMetro

Follow us on Twitter and like us on Facebook for news and conversation.

Two nurses in Westchester County have filed a $200,000 lawsuit against Douglas Kennedy, a son of Robert F. Kennedy, accusing him of assault and battery, negligence and causing them emotional and physical distress after an episode involving his newborn son.

The Journal News of Westchester reported that the lawsuit was filed on Tuesday, a week after a court in Mount Kisco, N.Y., acquitted Mr. Kennedy of child-endangerment and harassment charges.

The charges stemmed from Mr. Kennedy's attempt in January to take his newborn son from a maternity ward.

The two nurses said Mr. Kennedy hurt them as they tried to prevent him from leaving with the newborn. Mr. Kennedy said he was just taking the baby outside for some fresh air.

In a statement, Mr. Kennedy vowed to fight the lawsuit and said it was an attempt to extort money from his family.

13.57 | 0 komentar | Read More

F.D.A. May Tap Experts on Energy Drinks

The Food and Drug Administration said in a letter released on Tuesday that it was likely to seek advice from outside experts to help determine whether energy drinks posed particular risks to teenagers or people with underlying health problems.

The letter appears to signal a change in the agency's approach to the drinks, which contain high levels of caffeine.

Previously, F.D.A. officials have said that they were investigating possible risks posed by popular products like 5-Hour Energy, Monster Energy and Red Bull. But an agency spokeswoman, Shelly Burgess, said the new letter was the first time that the F.D.A. had said it might turn to outside experts.

The F.D.A. letter, which was released Tuesday by Senator Richard J. Durbin of Illinois and Senator Richard Blumenthal of Connecticut, follows disclosures that the agency received reports of 18 deaths and over 150 injuries that mentioned the possible involvement of energy drinks.

The filing of such reports with the F.D.A. does not prove that a product was responsible for a death or an injury. Energy drink makers have said their products are safe and were not responsible for the health problems.

The officials said a review of the drinks might be "greatly enhanced by also engaging specialized expertise" from an outside group, like the Institute of Medicine, which is part of the National Academy of Sciences.

Industry analysts said the letter indicated that the F.D.A. did not plan any immediate actions on energy drinks, an interpretation that set off a rally on Tuesday in the stock of Monster Beverage, the producer of Monster Energy. Company shares closed at $51.97, up over 13 percent. Any regulatory outcome is likely to be "benign," Judy Hong, an analyst at Goldman Sachs, said in a note to investors, according to Bloomberg News.

In Canada, however, the use of an outside panel led to limits on caffeine levels in energy drinks.

In their letter, F.D.A. officials indicated that an outside review would focus on the possible risks posed by high levels of caffeine, a stimulant, to certain groups. They reiterated that daily consumption of significant levels of caffeine, which is found in products like coffee and tea, is safe.

"Areas of particular focus would include such matters as the vulnerability of certain populations to stimulants and the incidence and consequence of excessive consumption" of energy drinks, especially by young people, F.D.A. officials wrote.

In Canada, an expert panel made several recommendations, including arguing that such beverages be labeled "stimulant drug-containing drinks."

Health Canada, that country's counterpart to the F.D.A., did not adopt many of the group's recommendations, but it has put in place new rules limiting caffeine levels in cans of energy drinks to 180 milligrams.

Some larger-size cans of energy drinks sold in the United States, like the 24-ounce can of Monster Energy and the 20-ounce can of Red Bull, have caffeine levels above that limit.

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

In the new letter, F.D.A. officials also said that studies that had examined other ingredients, like taurine, that are often used in energy drinks had determined those substances were safe. The agency also said that a survey suggested that energy drinks constitute a small portion of the caffeine consumed in this country, even by teenagers.

13.57 | 0 komentar | Read More

Amid Hurricane Sandy, a Race to Get a Liver Transplant

Charles Manley/The New York Times

Vin and Dolores Dreeland with their daughter Natalia and Dr. Tomoaki Kato, second left, and Dr. Nadia Ovchinsky, center, at NewYork-Presbyterian Morgan Stanley Children's Hospital.

It was the best possible news, at the worst possible time.

The phone call from the hospital brought the message that Dolores and Vin Dreeland had long hoped for, ever since their daughter Natalia, 4, had been put on the waiting list for a liver transplant. The time had come.

They bundled her into the car for the 50-mile trip from their home in Long Valley, N.J., to NewYork-Presbyterian Morgan Stanley Children's Hospital in Manhattan. But it soon seemed that this chance to save Natalia's life might be just out of reach.

The date was Sunday, Oct. 28, and Hurricane Sandy, the worst storm to hit the East Coast in decades, was bearing down on New York. Airports and bridges would soon close, but the donated organ was in Nevada, five hours away. The time window in which a plane carrying the liver would be able to land in the region was rapidly closing.

In a hospital room, Natalia watched cartoons. Her parents watched the clock, and the weather. "Our anxiety was through the roof," Mrs. Dreeland said. "It just made your stomach into knots."

The Dreelands, who are in their 60s, became Natalia's foster parents in 2008 when she was 7 months old, and adopted her just before she turned 2. They have another adopted daughter, Dorothy Jane, who is 17.

Natalia is a "smart little cookie" who loves school and dressing up Alice, her favorite doll, her mother said. At age 3, Natalia used the word "discombobulated" correctly, Mr. Dreeland said.

Natalia's health problems date back several years. Her gallbladder was taken out in 2010, and about half her liver was removed in 2011. The underlying problem was a rare disease, Langerhans cell histiocytosis. It causes a tremendous overgrowth of a type of cell in the immune system and can damage organs. Drugs can sometimes keep it in check, but they did not work for Natalia.

In her case, the disease struck the bile ducts, which led to progressive liver damage. "She would have eventually gone into liver failure," said Dr. Nadia Ovchinsky, a pediatric liver transplant specialist at NewYork-Presbyterian. "And she demonstrated some signs of early liver failure."

The only hope was a transplant.

Dr. Tomoaki Kato, Natalia's surgeon, knew that the liver in Nevada was a perfect match for Natalia in the two criteria that matter most: blood type and size. The deceased donor was 2 years old, and though Natalia is nearly 5, she is small for her age. Scar tissue from her previous operations would have made it very difficult to fit a larger organ into her abdomen.

Though Dr. Kato had considered transplanting part of an adult liver into Natalia, a complete organ from a child would be far better for her. But healthy organs from small children do not often become available, Dr. Kato said. This was a rare opportunity, and he was determined to seize it.

But as the day wore on, the odds for Natalia grew slimmer. The operation in Nevada to remove the liver was delayed several times.

At many hospitals, surgery to remove donor organs is done at the end of the day, after all regularly scheduled operations. The Nevada hospital had a busy surgical schedule that day, made worse by a trauma case that took priority.

At the hospital in New York, Tod Brown, an organ procurement coordinator, had alerted a charter air carrier that a flight from Nevada might be needed. That company in turn contacted West Coast carriers to pick up the donated liver and fly it to New York.

Initially, two carriers agreed, but then backed out. Several other charter companies also declined.

Mr. Brown told Dr. Kato that they might have to decline the organ. Dr. Kato, soft-spoken but relentless, said, "Find somebody who can fly."

Dr. Kato used to work in Miami, where pilots found ways to bypass hurricanes to deliver organs. Even during Hurricane Katrina, his hospital performed transplants.

"I asked the transplant coordinators to just keep pushing," he said.

Mr. Brown said, "Dr. Kato knew he was going to get that organ, one way or another."

As the trajectory of the storm became clearer, one of the West Coast charter companies agreed to attempt the flight. The plan was to land at the airport in Teterboro, N.J. The backup was Newark airport, and the second backup was Albany, from where an ambulance would finish the trip.

The timing was critical: organs deteriorate outside the body, and ideally a liver should be transplanted within 12 hours of being removed.

Early Monday, as the storm whirled offshore, the plane landed at Teterboro. Soon a nurse rushed to tell the Dreelands that she had just seen an ambulance with lights and sirens screech up to the hospital. Someone had jumped out carrying a container.

At about 5 a.m., the couple kissed Natalia and saw her wheeled off to the operating room.

Three weeks later, she is back home, on the mend. The complicated regimen of drugs that transplant patients need is tough on a child, but she is getting through it, her father said.

Recently, Mr. Dreeland said, he found himself weeping uncontrollably during a church service for the family of the child who had died. "Their child gave my child life," he said.

Though only time will tell, because the histiocytosis appeared limited to Natalia's bile ducts and had not affected other organs, her doctors say there is a good chance that the transplant has cured her.

This article has been revised to reflect the following correction:

Correction: November 28, 2012

Because of an editing error, a picture caption with an article on Tuesday about a girl who received a liver transplant during Hurricane Sandy misspelled the surname of the girl's family. As the article correctly noted, it is Dreeland, not Vreeland.

13.57 | 0 komentar | Read More

Letters: Cycle of Birth and Death (1 Letter)

To the Editor:

Re "Amid Cosmic Fatigue, Scarcely a Star Is Born" (Out There, Nov. 20): Though one may bemoan the rapidly declining birthrate of stars, the inescapable fact is that everything ends. People live for about 80 years, but any one of us could die tomorrow. As for our species, a cosmic impact causing mass extinctions like that of the dinosaurs occurs every 100 million years or so, although we may extinguish ourselves long before that through war or by destroying our environment.

Our planet will be incinerated in about 5 billion years when our Sun, in its own death throes, becomes a red giant. And our Milky Way galaxy will collide and merge with Andromeda in 3 to 4 billion years. Even the universe itself will end in either fire or ice, depending on whether its expansion continues forever, causing a "big rip," or is reversed, resulting in a "big crunch."

Happy holidays!

Stephen A. Silver

San Francisco

13.57 | 0 komentar | Read More

Global Update: Investing in Eyeglasses for Poor Would Boost International Economy

BSIP/UIG Via Getty Images

Eliminating the worldwide shortage of eyeglasses could cost up to $28 billion, but would add more than $200 billion to the global economy, according to a study published last month in the Bulletin of the World Health Organization.

The $28 billion would cover the cost of training 65,000 optometrists and equipping clinics where they could prescribe eyeglasses, which can now be mass-produced for as little as $2 a pair. The study was done by scientists from Australia and the Johns Hopkins Bloomberg School of Public Health.

The authors assumed that 703 million people worldwide have uncorrected nearsightedness or farsightedness severe enough to impair their work, and that 80 percent of them could be helped with off-the-rack glasses, which would need to be replaced every five years.

The biggest productivity savings from better vision would not be in very poor regions like Africa but in moderately poor countries where more people have factory jobs or trades like driving or running a sewing machine.

Without the equivalent of reading glasses, "lots of skilled crafts become very difficult after age 40 or 45," said Kevin Frick, a Johns Hopkins health policy economist and study co-author. "You don't want to be swinging a hammer if you can't see the nail."

If millions of schoolchildren who need glasses got them, the return on investment could be even greater, he said, but that would be in the future and was not calculated in this study.

13.57 | 0 komentar | Read More

Clearing the Fog Around Personality Disorders

For years they have lived as orphans and outliers, a colony of misfit characters on their own island: the bizarre one and the needy one, the untrusting and the crooked, the grandiose and the cowardly.

Their customs and rituals are as captivating as any tribe's, and at least as mystifying. Every mental anthropologist who has visited their world seems to walk away with a different story, a new model to explain those strange behaviors.

This weekend the Board of Trustees of the American Psychiatric Association will vote on whether to adopt a new diagnostic system for some of the most serious, and striking, syndromes in medicine: personality disorders.

Personality disorders occupy a troublesome niche in psychiatry. The 10 recognized syndromes are fairly well represented on the self-help shelves of bookstores and include such well-known types as narcissistic personality disorder, avoidant personality disorder, as well as dependent and histrionic personalities.

But when full-blown, the disorders are difficult to characterize and treat, and doctors seldom do careful evaluations, missing or downplaying behavior patterns that underlie problems like depression and anxiety in millions of people.

The new proposal — part of the psychiatric association's effort of many years to update its influential diagnostic manual — is intended to clarify these diagnoses and better integrate them into clinical practice, to extend and improve treatment. But the effort has run into so much opposition that it will probably be relegated to the back of the manual, if it's allowed in at all.

Dr. David J. Kupfer, a professor of psychiatry at the University of Pittsburgh and chairman of the task force updating the manual, would not speculate on which way the vote might go: "All I can say is that personality disorders were one of the first things we tackled, but that doesn't make it the easiest."

The entire exercise has forced psychiatrists to confront one of the field's most elementary, yet still unresolved, questions: What, exactly, is a personality problem?

Habits of Thought

It wasn't supposed to be this difficult.

Personality problems aren't exactly new or hidden. They play out in Greek mythology, from Narcissus to the sadistic Ares. They percolate through biblical stories of madmen, compulsives and charismatics. They are writ large across the 20th century, with its rogues' gallery of vainglorious, murderous dictators.

Yet it turns out that producing precise, lasting definitions of extreme behavior patterns is exhausting work. It took more than a decade of observing patients before the German psychiatrist Emil Kraepelin could draw a clear line between psychotic disorders, like schizophrenia, and mood problems, like depression or bipolar disorder.

Likewise, Freud spent years formulating his theories on the origins of neurotic syndromes. And Freudian analysts were largely the ones who, in the early decades of the last century, described people with the sort of "confounded identities" that are now considered personality disorders.

Their problems were not periodic symptoms, like moodiness or panic attacks, but issues rooted in longstanding habits of thought and feeling — in who they were.

"These therapists saw people coming into treatment who looked well put-together on the surface but on the couch became very disorganized, very impaired," said Mark F. Lenzenweger, a professor of psychology at the State University of New York at Binghamton. "They had problems that were neither psychotic nor neurotic. They represented something else altogether."

Several prototypes soon began to emerge. "A pedantic sense of order is typical of the compulsive character," wrote the Freudian analyst Wilhelm Reich in his 1933 book, "Character Analysis," a groundbreaking text. "In both big and small things, he lives his life according to a preconceived, irrevocable pattern."

Others coalesced too, most recognizable as extreme forms of everyday types: the narcissist, with his fragile, grandiose self-approval; the dependent, with her smothering clinginess; the histrionic, always in the thick of some drama, desperate to be the center of attention.

In the late 1970s, Ted Millon, scientific director of the Institute for Advanced Studies in Personology and Psychopathology, pulled together the bulk of the work on personality disorders, most of it descriptive, and turned it into a set of 10 standardized types for the American Psychiatric Association's third diagnostic manual. Published in 1980, it is a best seller among mental health workers worldwide.

These diagnostic criteria held up well for years and led to improved treatments for some people, like those with borderline personality disorder. Borderline is characterized by an extreme neediness and urges to harm oneself, often including thoughts of suicide. Many who seek help for depression also turn out to have borderline patterns, making their mood problems resistant to the usual therapies, like antidepressant drugs.

Today there are several approaches that can relieve borderline symptoms and one that, in numerous studies, has reduced hospitalizations and helped aid recovery: dialectical behavior therapy.

This progress notwithstanding, many in the field began to argue that the diagnostic catalog needed a rewrite. For one thing, some of the categories overlapped, and troubled people often got two or more personality diagnoses. "Personality Disorder-Not Otherwise Specified," a catchall label meaning little more than "this person has problems" became the most common of the diagnoses.

It's a murky area, and in recent years many therapists didn't have the time or training to evaluate personality on top of everything else. The assessment interviews can last hours, and treatments for most of the disorders involve longer-term, specialized talk therapy.

Psychiatry was failing the sort of patients that no other field could possibly help, many experts said.

"The diagnoses simply weren't being used very much, and there was a real need to make the whole system much more accessible," Dr. Lenzenweger said.

Resisting Simplification 

It was easier said than done.

The most central, memorable, and knowable element of any person — personality — still defies any consensus.

A team of experts appointed by the psychiatric association has worked for more than five years to find some unifying system of diagnosis for personality problems.

The panel proposed a system based in part on a failure to "develop a coherent sense of self or identity." Not good enough, some psychiatric theorists said.

Later, the experts tied elements of the disorders to distortions in basic traits.

13.57 | 0 komentar | Read More

Books: Woe Is Syphilis, and Other Afflictions of Famous Writers

The old Irishman was a swollen, wheezing mess, blood pressure wildly out of control, kidneys failing, heart fibrillating. "What we have here," said his new Spanish doctor, "is an antique cardiorenal sclerotic of advanced years."

In fact, what the doctor had there was William Butler Yeats: the poet had a long list of chronic medical problems and experienced one of his regular cardiac crises while wintering in Spain. He still had three poetically productive years ahead of him before he died of heart failure in 1939, at age 73.

What makes antique case histories like Yeats's so compelling to research, so interesting to read? Admittedly, they have educational value — medicine moves forward by looking back — but their major attraction is undoubtedly the operatic vigor of their emotional punch. As we contemplate the poor health of historic notables, we can sigh gustily at the immense suffering our ancestors considered routine, wince at the lunatic treatments they so innocently underwent, and marvel over and over again that the body, the brain and the mind can take such divergent paths.

These pleasures are present in abundance in the newest addition to the genre of medical biography, "Shakespeare's Tremor and Orwell's Cough." Dr. John J. Ross, a Harvard physician, writes that he stumbled into the field by accident while trying to enliven a lecture on syphilis with a few literary references. The discovery that Shakespeare was apparently obsessed with syphilis (and suspiciously familiar with its symptoms) hooked Dr. Ross.

The resulting collection of 10 medico-literary biographical sketches ranges from the tubercular Brontës, whose every moist cough is familiar to their fans, to figures like Nathaniel Hawthorne, whose medical stories are considerably less familiar.

Dr. Ross's discussion of Shakespeare is unique in the collection for its paucity of relevant data: so few details are known of the playwright's life, let alone his health, that all commentary is necessarily supposition. Dr. Ross is not the first to note that references to syphilis are "more abundant, intrusive and clinically exact" in Shakespeare's works than those of his contemporaries. This observation, along with the apparent deterioration of Shakespeare's handwriting in his last years, leads to the hypothesis that Shakespeare had syphilis repeatedly as a young man, and wound up suffering more from treatment than disease.

The Elizabethans dosed syphilis with a combination of hot baths (treating the disease by raising body temperature endured into the 20th century), cathartics and lavish quantities of mercury. The drooling that accompanies mercury poisoning was considered a sign of excellent therapeutic progress, Dr. Ross writes: "Savvy physicians adjusted the mercury dose to produce three pints of saliva a day for two weeks."

And so, when Shakespeare signed his will a month before he died with a shaky hand, was his tremor not possibly a sign of residual nerve damage from the mercury doses of his sybaritic youth? No amount of scholarship is likely to confirm this theory, but details of the argument are gripping and instructive nonetheless.

The story of the blind poet John Milton runs for a while along similar lines. Much is known about the long deterioration of Milton's vision and other particulars of his delicate health, but Dr. Ross observes that many of his problems seem to have cleared up once he actually became blind. Was he vigorously medicating himself with lead-based nostrums in hopes of forestalling what Dr. Ross argues was probably progressive retinal detachment, then recovering from lead poisoning once his vision was irretrievably gone? Another intriguing if unanswerable question.

Just as the competing injuries of disease and treatment battered the luminaries of English and American literature, so did pervasive mental illness.

Jonathan Swift was a classic obsessive-compulsive long before he succumbed to frontotemporal dementia (Pick's disease). Poor Hawthorne, so forceful on the page, was in person a tortured shrinking violet, the embodiment of social phobia and depression. Emily Brontë's behavior was strongly suggestive of Asperger syndrome; Herman Melville was clearly bipolar; Ezra Pound was just nuts.

Yet they all wrote on, despite continual psychic and physical torments. Perhaps the thickest medical chart of all belongs to Jack London, who survived several dramatic episodes of scurvy while prospecting in the Klondike (he was treated with raw potatoes, a can of tomatoes and a single lemon), then accumulated a long list of other medical problems before killing himself (inadvertently, Dr. Ross argues) with an overdose of morphine from his personal and very capacious medicine chest.

Dr. Ross has not written a perfect book. The fictionalized scenes he creates between some of his subjects and their medical providers should all have been excised by a kindly editorial hand, which might also have addressed more than a few grammatical errors. Frequent leaps from descriptive to didactic mode as Dr. Ross updates the reader on various medical conditions can be jarring, like PowerPoint slides suddenly deployed in a poetry reading. True literary scholars might dismiss the book as lit crit lite, a hodgepodge of known facts culled from the usual secondary sources.

But all these caveats fade into the background when Dr. Ross hits his narrative stride, as he does in chapter after chapter. Then the stories of the wounded storytellers unfold smoothly on the page, as mesmerizing as any they themselves might have told, those squinting, wheezing, arthritic, infected, demented, defective yet superlative examples of the human condition.

13.57 | 0 komentar | Read More

M.I.T. Lab Hatches Ideas, and Companies, by the Dozens

HOW do you take particles in a test tube, or components in a tiny chip, and turn them into a $100 million company?

Dr. Robert Langer, 64, knows how. Since the 1980s, his Langer Lab at the Massachusetts Institute of Technology has spun out companies whose products treat cancer, diabetes, heart disease and schizophrenia, among other diseases, and even thicken hair.

The Langer Lab is on the front lines of turning discoveries made in the lab into a range of drugs and drug delivery systems. Without this kind of technology transfer, the thinking goes, scientific discoveries might well sit on the shelf, stifling innovation.

A chemical engineer by training, Dr. Langer has helped start 25 companies and has 811 patents, issued or pending, to his name. That's not too far behind Thomas Edison, who had 1,093. More than 250 companies have licensed or sublicensed Langer Lab patents.

Polaris Venture Partners, a Boston venture capital firm, has invested $220 million in 18 Langer Lab-inspired businesses. Combined, these businesses have improved the health of many millions of people, says Terry McGuire, co-founder of Polaris.

Along the way, Dr. Langer and his lab, including about 60 postdoctoral and graduate students at a time, have found a way to navigate some slippery territory: the intersection of academic research and the commercial market.

Over the last 30 years, many universities — including M.I.T. — have set up licensing offices that oversee the transfer of scientific discoveries to companies. These offices have become a major pathway for universities seeking to put their research to practical use, not to mention add to their revenue streams.

In the sciences in particular, technology transfer has become a key way to bring drugs and other treatments to market. "The model of biomedical innovation relies on research coming out of universities, often funded by public money," says Josephine Johnston, director of research at the Hastings Center, a bioethics research organization based in Garrison, N.Y.

Just a few of the products that have emerged from the Langer Lab are a small wafer that delivers a dose of chemotherapy used to treat brain cancer; sugar-sequencing tools that can be used to create new drugs like safer and more effective blood thinners; and a miniaturized chip (a form of nanotechnology) that can test for diseases.

The chemotherapy wafer, called the Gliadel, is licensed by Eisai Inc. The company behind the sugar-sequencing tools, Momenta Pharmaceuticals, raised $28.4 million in an initial public offering in 2004. The miniaturized chip is made by T2Biosystems,  which completed a $23 million round of financing in the summer of 2011.

"It's inconvenient to have to send things to a lab," so the company is trying to develop more sophisticated methods, says Dr. Ralph Weissleder, a co-founder, with Dr. Langer and others, of T2Biosystems and a professor at Harvard Medical School.

FOR Dr. Langer, starting a company is not the same as it was, say, for Mark Zuckerberg with Facebook. "Bob is not consumed with any one company," says H. Kent Bowen, an emeritus professor of business administration at Harvard Business School who wrote a case study on the Langer Lab. "His mission is to create the idea."

Dr. Bowen observes that there are many other academic laboratories, including highly productive ones, but that the Langer Lab's combination of people, spun-out companies and publications sets it apart. He says Dr. Langer "walks into the great unknown and then makes these discoveries."

Dr. Langer is well known for his mentoring abilities. He is "notorious for replying to e-mail in two minutes, whether it's a lowly graduate school student or the president of the United States," says Paulina Hill, who worked in his lab from 2009 to 2011 and is now a senior associate at Polaris Venture Partners. (According to Dr. Langer, he has corresponded directly with President Obama about stem cell research and federal funds for the sciences.)

Dr. Langer says he looks at his students "as an extended family," adding that "I really want them to do well."

And they have, whether in business or in academia, or a combination of the two. One former student, Ram Sasisekharan, helped found Momenta and now runs his own lab at M.I.T. Ganesh Venkataraman Kaundinya is Momenta's chief scientific officer and senior vice president for research.

Hongming Chen is vice president of research at Kala Pharmaceuticals. Howard Bernstein is chief scientific officer at Seventh Sense Biosystems, a blood-testing company. Still others have taken jobs in the law or in government.

Dr. Langer says he spends about eight hours a week working on companies that come out of his lab. Of the 25 that he helped start, he serves on the boards of 12 and is an informal adviser to 4. All of his entrepreneurial activity, which includes some equity stakes, has made him a millionaire. But he says he is mainly motivated by a desire to improve people's health.

Operating from the sixth floor of the David H. Koch Institute for Integrative Cancer Research on the M.I.T. campus in Cambridge, Mass., Dr. Langer's lab has a research budget of more than $10 million for 2012, coming mostly from federal sources.

The research in labs like Dr. Langer's is eyed closely by pharmaceutical companies. While drug companies employ huge research and development teams, they may not be as freewheeling and nimble, Dr. Langer says. The basis for many long-range discoveries has "come out of academia, including gene therapy, gene sequencing and tissue engineering," he says.

He has served as a consultant to pharmaceutical companies. Their large size, he says, can end up being an impediment.

"Very often when you are going for real innovation," he says, "you have to go against prevailing wisdom, and it's hard to go against prevailing wisdom when there are people who have been there for a long time and you have some vice president who says, 'No, that doesn't make sense.' "

Pharmaceutical companies are eager to tap into the talent at leading research universities. In 2008, for example, Washington University in St. Louis announced a $25 million pact with Pfizer to collaborate more closely on biomedical research.

But in some situations, the close — critics might say cozy — ties between business and academia have the potential to create conflicts of interest.

There was a controversy earlier this year when it was revealed that the president of the University of Texas M.D. Anderson Cancer Center owned stock in Aveo Oncology, which had announced earlier that the university would be leading clinical trials of one of its cancer drugs.  Last month, the University of Texas announced that he would be allowed to keep his ties with three pharmaceutical companies, including Aveo Oncology; his holdings will be placed in a blind trust.

13.57 | 0 komentar | Read More

Well: Mindful Medicine for the Terminally Ill

The woman was terminally ill with advanced cancer, and the oncologist who had been treating her for three years thought the next step might be to deliver chemotherapy directly to her brain. It was a risky treatment that he knew would not, could not, help her.

When Dr. Diane E. Meier asked what he thought the futile therapy would accomplish, the oncologist replied, "I don't want Judy to think I'm abandoning her."

In a recent interview, Dr. Meier said, "Most physicians have no other strategies, no other arrows in their quiver beyond administering tests and treatments."

"To avoid feeling that they've abandoned their patients, doctors throw procedures at them," she said.

Dr. Meier, a renowned expert on palliative care at Mount Sinai Medical Center in New York, was the keynote speaker this month at the Buddhist Contemplative Care Symposium, organized by the New York Zen Center for Contemplative Care and the Garrison Institute. She described contemplative care as "the discipline of being present, of listening before acting."

"Counter to how the American medical system is structured, which pays for what gets done," she said, "its approach is, 'Don't just do something, stand there.' "

But the idea is not to do just that. Rather, she said, the goal is to "restore the patient to the center of the enterprise."

Under the Affordable Care Act, she said, unnecessary procedures may decline as more doctors are reimbursed for doing what is best for their patients over time, not just for administering tests and treatments. But more could be done if physicians were able to step away from the misperception that everything that can be done should be done.

Dr. Meier's question prompted Judy's doctor to realize that what his patient needed most at the end of her life was not more chemotherapy, but for him to sit down with her, to promise to do his best to keep her comfortable and to be there for the rest of her days.

Doctors Suffer, Too

Patients and families may not realize it, but doctors who care for people with incurable illness, and especially the terminally ill, often grieve with their patients. Unable to cope with their own feelings of frustration, failure and helplessness, doctors may react with anger, abruptness and avoidance.

Visits may be reduced to a quick review of the medical chart, and phone calls may not be returned. Even though their doctors are still there, incurably ill patients may feel neglected and depressed. Dr. Michael K. Kearney, a palliative care physician at Santa Barbara Cottage Hospital, told the Contemplative Care conference that doctors, especially those who care for terminally ill patients, are subject to two serious forms of occupational stress: burnout and compassion fatigue.

He described burnout as "the end stage of stresses between the individual and the work environment" that can result in emotional and physical exhaustion, a sense of detachment and a feeling of never being able to achieve one's professional goals.

He likened compassion fatigue to "secondary post-traumatic stress disorder, or vicarious traumatization — trauma suffered when someone close to you is suffering."

A doctor with compassion fatigue may avoid thoughts and feelings associated with a patient's pain, become irritable and easily angered, and face physical and emotional distress when reminded of work with the dying. Compassion fatigue can lead to burnout.

In one study of 18 oncologists, published in 2008 in the Journal of Palliative Medicine, those who saw their role as both biomedical and psychosocial found end-of-life care very satisfying. But those "who described a primarily biomedical role reported a more distant relationship with the patient, a sense of failure at not being able to alter the course of the disease and an absence of collegial support," the authors noted.

Healing the Healer

For doctors at risk of becoming overwhelmed by the stresses of their jobs, Dr. Kearney recommends adopting the time-honored Buddhist practice of "mindfulness meditation," which involves cultivating mental techniques for stress reduction that are native to all of us but practiced by too few. He likened meditation to "learning to breathe underwater, or finding sources of renewal within work itself."

To achieve it, a person sits quietly, paying attention to one's breathing and whenever a distracting thought intrudes, turning one's attention back to the sensation of breathing. This can help calm the mind and prepare it for a clearer perspective.

Dr. Kearney said this practice could help doctors "really pay attention and be tuned into their patients and what the patients are experiencing."

"Patients, in turn," he said, "experience a doctor who's not just focused on a medical agenda but who really listens to them."

He said mindfulness meditation helps doctors become more self-aware, empathetic and patient-focused, and to make fewer medical errors. It enables doctors to notice what is going on within themselves and to consider rational options instead of just reacting.

"It's like pressing an internal pause button," Dr. Kearney said. "The doctor is able to recognize he's being stressed, and it prevents him from invoking the survival defense mechanisms of fight ('Let's do another course of chemotherapy'), flight ('There's nothing more I can do for you — I'll go get the chaplain') and freeze (the doctor goes blank and does nothing)." Such reactions can be highly distressing to a dying patient.

When a patient asks for the impossible, like "Promise me I'm not going to die," the mindful doctor is more likely to step back and say, "I can promise you I'll do everything I can to help you. I'm going to continue to care for you and support you as best as I can. I'll be back to see you later today and again tomorrow," Dr. Kearney said.

Although Dr. Kearney does mindfulness meditation for 30 minutes every morning, he said as little as 8 to 10 minutes a day has been shown helpful to practicing physicians.

In addition, doctors can factor moments of meditation into the course of the workday — say, while washing their hands, having a snack or coffee or pausing before entering the next patient room to focus on breathing.

To deal with the emotional flood that can come after a traumatic event, he suggested taking a brief timeout or calling a colleague to say "I need a walk."

13.57 | 0 komentar | Read More

Agency Investigates Deaths and Injuries Associated With Bed Rails

Thomas Patterson for The New York Times

Gloria Black's mother died in her bed at a care facility.

In November 2006, when Clara Marshall began suffering from the effects of dementia, her family moved her into the Waterford at Fairway Village, an assisted living home in Vancouver, Wash. The facility offered round-the-clock care for Ms. Marshall, who had wandered away from home several times. Her husband Dan, 80 years old at the time, felt he could no longer care for her alone.

Thomas Patterson for The New York Times

Gloria Black, visiting her mother's grave in Portland, Ore. She has documented hundreds of deaths associated with bed rails and said families should be informed of their possible risks.

But just five months into her stay, Ms. Marshall, 81, was found dead in her room apparently strangled after getting her neck caught in side rails used to prevent her from rolling out of bed.

After Ms. Marshall's death, her daughter Gloria Black, who lives in Portland, Ore., began writing to the Consumer Product Safety Commission and the Food and Drug Administration. What she discovered was that both agencies had known for more than a decade about deaths from bed rails but had done little to crack down on the companies that make them. Ms. Black conducted her own research and exchanged letters with local and state officials. Finally, a letter she wrote in 2010 to the federal consumer safety commission helped prompt a review of bed rail deaths.

Ms. Black applauds the decision to study the issue. "But I wish it was done years ago," she said. "Maybe my mother would still be alive." Now the government is studying a problem it has known about for years.

Data compiled by the consumer agency from death certificates and hospital emergency room visits from 2003 through May 2012 shows that 150 mostly older adults died after they became trapped in bed rails. Over nearly the same time period, 36,000 mostly older adults — about 4,000 a year — were treated in emergency rooms with bed rail injuries. Officials at the F.D.A. and the commission said the data probably understated the problem since bed rails are not always listed as a cause of death by nursing homes and coroners, or as a cause of injury by emergency room doctors.

Experts who have studied the deaths say they are avoidable. While the F.D.A. issued safety warnings about the devices in 1995, it shied away from requiring manufacturers to put safety labels on them because of industry resistance and because the mood in Congress then was for less regulation. Instead only "voluntary guidelines" were adopted in 2006.

More warnings are needed, experts say, but there is a technical question over which regulator is responsible for some bed rails. Are they medical devices under the purview of the F.D.A., or are they consumer products regulated by the commission?

"This is an entirely preventable problem," said Dr. Steven Miles, a professor at the Center for Bioethics at the University of Minnesota, who first alerted federal regulators to deaths involving bed rails in 1995. The government at the time declined to recall any bed rails and opted instead for a safety alert to nursing homes and home health care agencies.

Forcing the industry to improve designs and replace older models could have potentially cost bed rail makers and health care facilities hundreds of million of dollars, said Larry Kessler, a former F.D.A. official who headed its medical device office. "Quite frankly, none of the bed rails in use at that time would have passed the suggested design standards in the guidelines if we had made them mandatory," he said. No analysis has been done to determine how much it would cost the manufacturers to reduce the hazards.

Bed rails are metal bars used on hospital beds and in home care to assist patients in pulling themselves up or helping them out of bed. They can also prevent people from rolling out of bed. But sometimes patients — particularly those suffering from Alzheimer's — can get confused and trapped between a bed rail and a mattress, which can lead to serious injury or even death.

While the use of the devices by hospitals and nursing homes has declined as professional caregivers have grown aware of the dangers, experts say dozens of older adults continue to die each year as more rails are used in home care and many health care facilities continue to use older rail models.

Since those first warnings in 1995, about 550 bed rail-related deaths have occurred, a review by The New York Times of F.D.A. data, lawsuits, state nursing home inspection reports and interviews, found. Last year alone, the F.D.A. data shows, 27 people died.

As deaths continued after the F.D.A. warning, a working group put together in 1999 and made up of medical device makers, researchers, patient advocates and F.D.A. officials considered requiring bed rail makers to add warning labels.

But the F.D.A. decided against it after manufacturers resisted, citing legal issues. The agency said added cost to small manufacturers and difficulties of getting regulations through layers of government approval, were factors against tougher standards, according to a meeting log of the group in 2000 and interviews.

13.57 | 0 komentar | Read More

Dr. Eben Alexander’s Tells of Near Death in ‘Proof of Heaven’

For years Dr. Eben Alexander III had dismissed near-death revelations of God and heaven as explainable by the hard wiring of the human brain. He was, after all, a neurosurgeon with sophisticated medical training.

But then in 2008 Dr. Alexander contracted bacterial meningitis. The deadly infection soaked his brain and sent him into a deep coma.

During that week, as life slipped away, he now says, he was living intensely in his mind. He was reborn into a primitive mucky Jell-o-like substance and then guided by "a beautiful girl with high cheekbones and deep blue eyes" on the wings of a butterfly to an "immense void" that is both "pitch black" and "brimming with light" coming from an "orb" that interprets for an all-loving God.

Dr. Alexander, 58, was so changed by the experience that he felt compelled to write a book, "Proof of Heaven," that recounts his experience. He knew full well that he was gambling his professional reputation by writing it, but his hope is that his expertise will be enough to persuade skeptics, particularly medical skeptics, as he used to be, to open their minds to an afterworld.

Dr. Alexander acknowledged that tales of near-death experiences that reveal a bright light leading to compassionate world beyond are as old as time and by now seem trite. He is aware that his version of heaven is even more psychedelic than most — the butterflies, he explained, were not his choice, and anyway that was his "gateway" and not heaven itself.

Still, he said, he has a trump card: Having trained at Duke University and taught and practiced as a surgeon at Harvard, he knows brain science as well as anyone. And science, he said, cannot explain his experience.

"During my coma my brain wasn't working improperly," he writes in his book. "It wasn't working at all."

Simon & Schuster, which released the book on Oct. 23, is betting that it can appeal to very different but potentially lucrative audiences: those interested in neuroscience and those interested in mystical experiences. Already Dr. Alexander has been a guest on "The Dr. Oz Show" and is scheduled to appear as the sole guest of an hourlong special with Oprah Winfrey on Sunday.

"This book covers topics that are of interest to a lot of people: consciousness, near death, and heaven," said Priscilla Painton, the executive editor at Simon & Schuster, who acquired the book.

The company took the unusual step of releasing the book in hardcover, paperback and e-book format, so it could simultaneously sell to a wider range of readers — at Walmarts and grocery stores as well as independent bookstores and online. It rose instantly to No. 1 on The New York Times's paperback best-seller list and is there again for next week.

Ms. Painton would not elaborate on what type of audience the book had attracted so far, but she did say she expected it to continue to be a big seller. The publisher has printed nearly one million copies, combined hardcover and paperback, to be snapped up at airports and as stocking stuffers at big retailers like Target. Another 78,000 digital copes have been sold.

In a recent interview at the Algonquin Hotel lobby in Manhattan, however, Dr. Alexander made it clear that he was less interested in appealing to religious "believers," even though they had been a core audience for similar books.

He rejected the idea that readers of his book would be the same as those who bought "Heaven Is for Real," a 2010 mega best-seller about a preacher's son who sat on Jesus' lap during a near-death experience.

"It is totally different," he insisted. "Those who believed in heaven when they read the book were not happy. They didn't like the title. They say, 'This is not scientific proof.' "

In fact, he said, "Proof of Heaven" was not his idea for a title. He preferred "An N of One," a reference to medical trials in which there is only a single patient.

Wearing a yellow bow tie, Dr. Alexander talked about his career and his years at Harvard, sounding every bit the part of a doctor one might trust to drill open skulls and manipulate their contents.

He left Harvard in 2001, he said, because he was tired of "medical politics." In 2006 he moved to Lynchburg, Va., where he did research on less invasive forms of brain surgery through focused X-rays and digital scanners. Then the meningitis felled him.

After recovering, he originally planned to write a scientific paper that would explain his intensely vivid recollections. But after consulting the existing literature and talking extensively to other colleagues in the field he decided no scientific explanation existed.

"My entire neocortex — the outer surface of the brain, the part that makes us human — was entirely shut down, inoperative," he said.

He hesitated nevertheless. It took him two years, he said, to even use the word God in discussing his experience. But then he felt an obligation to all those dealing with near-death experience, and particularly to his fellow doctors. He felt compelled to let them know.

So far he has spoken at the Lynchburg hospital, where he was treated, and said he has been invited to address a group of neurosurgeons at Stanford.

But these invitations, he acknowledged, do not mean that his theory is gaining ground among doctors. In private conversations, he said, very few of his colleagues offered counterarguments. Some agreed with his conclusion that science could not explain what he saw, but none of them were willing to be named in his book.

Other former colleagues reached for comment were not convinced. Dr. Martin Samuels, chairman of the neurology department at Brigham and Women's Hospital, a Harvard teaching affiliate, remembered Dr. Alexander as a competent neurosurgeon. But he said: "There is no way to know, in fact, that his neocortex was shut down. It sounds scientific, but it is an interpretation made after the fact."

"My own experience," Dr. Samuels added, "is that we all live in virtual reality, and the brain is the final arbiter. The fact that he is a neurosurgeon is no more relevant than if he was a plumber."

Dr. Alexander shrugs off such analysis. He still hopes to tour "major medical centers and hospices and nursing homes," he said, to relate his experience in distinctly medical environments.

His messages to those who deal with dying is one of relief. "Our spirit is not dependent on the brain or body," he said. "It is eternal, and no one has one sentence worth of hard evidence that it isn't."

This article has been revised to reflect the following correction:

Correction: November 25, 2012

An earlier version of this article misstated the term used for a clinical trial with only one patient. It is "an N of One,'' not "an In of One.''

13.57 | 0 komentar | Read More