Health Testing on Mice Is Found Misleading in Some Cases

Evan McGlinn for The New York Times

Dr. H. Shaw Warren is one of the authors of a new study that questions the use of laboratory mice as models for all human diseases.

For decades, mice have been the species of choice in the study of human diseases. But now, researchers report evidence that the mouse model has been totally misleading for at least three major killers — sepsis, burns and trauma. As a result, years and billions of dollars have been wasted following false leads, they say.

The study’s findings do not mean that mice are useless models for all human diseases. But, its authors said, they do raise troubling questions about diseases like the ones in the study that involve the immune system, including cancer and heart disease.

“Our article raises at least the possibility that a parallel situation may be present,” said Dr. H. Shaw Warren, a sepsis researcher at Massachusetts General Hospital and a lead author of the new study.

The paper, published Monday in Proceedings of the National Academy of Sciences, helps explain why every one of nearly 150 drugs tested at a huge expense in patients with sepsis has failed. The drug tests all were based on studies in mice. And mice, it turns out, can have something that looks like sepsis in humans, but is very different from the condition in humans.

Medical experts not associated with the study said that the findings should change the course of research worldwide for a deadly and frustrating condition. Sepsis, a potentially deadly reaction that occurs as the body tries to fight an infection, afflicts 750,000 patients a year in the United States, kills one-fourth to one-half of them, and costs the nation $17 billion a year. It is the leading cause of death in intensive-care units.

“This is a game changer,” said Dr. Mitchell Fink, a sepsis expert at the University of California, Los Angeles, of the new study.

“It’s amazing,” said Dr. Richard Wenzel, a former chairman at the department of internal medicine at Virginia Commonwealth University and a former editor of The New England Journal of Medicine. “They are absolutely right on.”

Potentially deadly immune responses occur when a person’s immune system overreacts to what it perceives as danger signals, including toxic molecules from bacteria, viruses, fungi, or proteins released from cells damaged by trauma or burns, said Dr. Clifford S. Deutschman, who directs sepsis research at the University of Pennsylvania and was not part of the study.

The ramped-up immune system releases its own proteins in such overwhelming amounts that capillaries begin to leak. The leak becomes excessive, and serum seeps out of the tiny blood vessels. Blood pressure falls, and vital organs do not get enough blood. Despite efforts, doctors and nurses in an intensive-care unit or an emergency room may be unable to keep up with the leaks, stop the infection or halt the tissue damage. Vital organs eventually fail.

The new study, which took 10 years and involved 39 researchers from across the country, began by studying white blood cells from hundreds of patients with severe burns, trauma or sepsis to see what genes were being used by white blood cells when responding to these danger signals.

The researchers found some interesting patterns and accumulated a large, rigorously collected data set that should help move the field forward, said Ronald W. Davis, a genomics expert at Stanford University and a lead author of the new paper. Some patterns seemed to predict who would survive and who would end up in intensive care, clinging to life and, often, dying.

The group had tried to publish its findings in several papers. One objection, Dr. Davis said, was that the researchers had not shown the same gene response had happened in mice.

“They were so used to doing mouse studies that they thought that was how you validate things,” he said. “They are so ingrained in trying to cure mice that they forget we are trying to cure humans.”

“That started us thinking,” he continued. “Is it the same in the mouse or not?”

The group decided to look, expecting to find some similarities. But when the data were analyzed, there were none at all.

“We were kind of blown away,” Dr. Davis said.

The drug failures became clear. For example, often in mice, a gene would be used, while in humans, the comparable gene would be suppressed. A drug that worked in mice by disabling that gene could make the response even more deadly in humans.

Even more surprising, Dr. Warren said, was that different conditions in mice — burns, trauma, sepsis — did not fit the same pattern. Each condition used different groups of genes. In humans, though, similar genes were used in all three conditions. That means, Dr. Warren said, that if researchers can find a drug that works for one of those conditions in people, it might work for all three.

This article has been revised to reflect the following correction:

Correction: February 11, 2013

An earlier version of this article misstated the position of Dr. Richard Wenzel. He is a former chairman of the department of internal medicine at Virginia Commonwealth University. He is not currently the chairman.

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For Families Struggling with Mental Illness, Carolyn Wolf Is a Guide in the Darkness

When a life starts to unravel, where do you turn for help?

Melissa Klump began to slip in the eighth grade. She couldn’t focus in class, and in a moment of despair she swallowed 60 ibuprofen tablets. She was smart, pretty and ill: depression, attention deficit disorder, obsessive-compulsive disorder, either bipolar disorder or borderline personality disorder.

In her 20s, after a more serious suicide attempt, her parents sent her to a residential psychiatric treatment center, and from there to another. It was the treatment of last resort. When she was discharged from the second center last August after slapping another resident, her mother, Elisa Klump, was beside herself.

“I was banging my head against the wall,” the mother said. “What do I do next?” She frantically called support groups, therapy programs, suicide prevention lines, anybody, running down a list of names in a directory of mental health resources. “Finally,” she said, “somebody told me, ‘The person you need to talk to is Carolyn Wolf.’ ”

That call, she said, changed her life and her daughter’s. “Carolyn has given me hope,” she said. “I didn’t know there were people like her out there.”

Carolyn Reinach Wolf is not a psychiatrist or a mental health professional, but a lawyer who has carved out what she says is a unique niche, working with families like the Klumps.

One in 17 American adults suffers from a severe mental illness, and the systems into which they are plunged — hospitals, insurance companies, courts, social services — can be fragmented and overwhelming for families to manage. The recent shootings in Newtown, Conn., and Aurora, Colo., have brought attention to the need for intervention to prevent such extreme acts of violence, which are rare. But for the great majority of families watching their loved ones suffer, and often suffering themselves, the struggle can be boundless, with little guidance along the way.

“If you Google ‘mental health lawyer,’ ” said Ms. Wolf, a partner with Abrams & Fensterman, “I’m kinda the only game in town.”

On a recent afternoon, she described in her Midtown office the range of her practice.

“We have been known to pull people out of crack dens,” she said. “I have chased people around hotels all over the city with the N.Y.P.D. and my team to get them to a hospital. I had a case years ago where the person was on his way back from Europe, and the family was very concerned that he was symptomatic. I had security people meet him at J.F.K.”

Many lawyers work with mentally ill people or their families, but Ron Honberg, the national director of policy and legal affairs for the National Alliance on Mental Illness, said he did not know of another lawyer who did what Ms. Wolf does: providing families with a team of psychiatrists, social workers, case managers, life coaches, security guards and others, and then coordinating their services. It can be a lifeline — for people who can afford it, Mr. Honberg said. “Otherwise, families have to do this on their own,” he said. “It’s a 24-hour, 7-day-a-week job, and for some families it never ends.”

Many of Ms. Wolf’s clients declined to be interviewed for this article, but the few who spoke offered an unusual window on the arcane twists and turns of the mental health care system, even for families with money. Their stories illustrate how fraught and sometimes blind such a journey can be.

One rainy morning last month, Lance Sheena, 29, sat with his mother in the spacious family room of her Long Island home. Mr. Sheena was puffy-eyed and sporadically inattentive; the previous night, at the group home where he has been living since late last summer, another resident had been screaming incoherently and was taken away by the police. His mother, Susan Sheena, eased delicately into the family story.

“I don’t talk to a lot of people because they don’t get it,” Ms. Sheena said. “They mean well, but they don’t get it unless they’ve been through a similar experience. And anytime something comes up, like the shooting in Newtown, right away it goes to the mentally ill. And you think, maybe we shouldn’t be so public about this, because people are going to be afraid of us and Lance. It’s a big concern.”

Her son cut her off. “Are you comparing me to the guy that shot those people?”

“No, I’m saying that anytime there’s a shooting, like in Aurora, that’s when these things come out in the news.”

“Did you really just compare me to that guy?”

“No, I didn’t compare you.”

“Then what did you say?”

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For Families Struggling with Mental Illness, Carolyn Wolf Is a Guide in the Darkness

When a life starts to unravel, where do you turn for help?

Melissa Klump began to slip in the eighth grade. She couldn’t focus in class, and in a moment of despair she swallowed 60 ibuprofen tablets. She was smart, pretty and ill: depression, attention deficit disorder, obsessive-compulsive disorder, either bipolar disorder or borderline personality disorder.

In her 20s, after a more serious suicide attempt, her parents sent her to a residential psychiatric treatment center, and from there to another. It was the treatment of last resort. When she was discharged from the second center last August after slapping another resident, her mother, Elisa Klump, was beside herself.

“I was banging my head against the wall,” the mother said. “What do I do next?” She frantically called support groups, therapy programs, suicide prevention lines, anybody, running down a list of names in a directory of mental health resources. “Finally,” she said, “somebody told me, ‘The person you need to talk to is Carolyn Wolf.’ ”

That call, she said, changed her life and her daughter’s. “Carolyn has given me hope,” she said. “I didn’t know there were people like her out there.”

Carolyn Reinach Wolf is not a psychiatrist or a mental health professional, but a lawyer who has carved out what she says is a unique niche, working with families like the Klumps.

One in 17 American adults suffers from a severe mental illness, and the systems into which they are plunged — hospitals, insurance companies, courts, social services — can be fragmented and overwhelming for families to manage. The recent shootings in Newtown, Conn., and Aurora, Colo., have brought attention to the need for intervention to prevent such extreme acts of violence, which are rare. But for the great majority of families watching their loved ones suffer, and often suffering themselves, the struggle can be boundless, with little guidance along the way.

“If you Google ‘mental health lawyer,’ ” said Ms. Wolf, a partner with Abrams & Fensterman, “I’m kinda the only game in town.”

On a recent afternoon, she described in her Midtown office the range of her practice.

“We have been known to pull people out of crack dens,” she said. “I have chased people around hotels all over the city with the N.Y.P.D. and my team to get them to a hospital. I had a case years ago where the person was on his way back from Europe, and the family was very concerned that he was symptomatic. I had security people meet him at J.F.K.”

Many lawyers work with mentally ill people or their families, but Ron Honberg, the national director of policy and legal affairs for the National Alliance on Mental Illness, said he did not know of another lawyer who did what Ms. Wolf does: providing families with a team of psychiatrists, social workers, case managers, life coaches, security guards and others, and then coordinating their services. It can be a lifeline — for people who can afford it, Mr. Honberg said. “Otherwise, families have to do this on their own,” he said. “It’s a 24-hour, 7-day-a-week job, and for some families it never ends.”

Many of Ms. Wolf’s clients declined to be interviewed for this article, but the few who spoke offered an unusual window on the arcane twists and turns of the mental health care system, even for families with money. Their stories illustrate how fraught and sometimes blind such a journey can be.

One rainy morning last month, Lance Sheena, 29, sat with his mother in the spacious family room of her Long Island home. Mr. Sheena was puffy-eyed and sporadically inattentive; the previous night, at the group home where he has been living since late last summer, another resident had been screaming incoherently and was taken away by the police. His mother, Susan Sheena, eased delicately into the family story.

“I don’t talk to a lot of people because they don’t get it,” Ms. Sheena said. “They mean well, but they don’t get it unless they’ve been through a similar experience. And anytime something comes up, like the shooting in Newtown, right away it goes to the mentally ill. And you think, maybe we shouldn’t be so public about this, because people are going to be afraid of us and Lance. It’s a big concern.”

Her son cut her off. “Are you comparing me to the guy that shot those people?”

“No, I’m saying that anytime there’s a shooting, like in Aurora, that’s when these things come out in the news.”

“Did you really just compare me to that guy?”

“No, I didn’t compare you.”

“Then what did you say?”

Read More..

Well: Think Like a Doctor: A Confused and Terrified Patient

The Challenge: Can you solve the mystery of a middle-aged man recovering from a serious illness who suddenly becomes frightened and confused?

Every month the Diagnosis column of The New York Times Magazine asks Well readers to sift through a difficult case and solve a diagnostic riddle. Below you will find a summary of a case involving a 55-year-old man well on his way to recovering from a series of illnesses when he suddenly becomes confused and paranoid. I will provide you with the main medical notes, labs and imaging results available to the doctor who made the diagnosis.

The first reader to figure out this case will get a signed copy of my book, “Every Patient Tells a Story,” along with the satisfaction of knowing you solved a case of Sherlockian complexity. Good luck.

The Presenting Problem:

A 55-year-old man who is recovering from a devastating injury in a rehabilitation facility suddenly becomes confused, frightened and paranoid.

The Patient’s Story:

The patient, who was recovering from a terrible injury and was too weak to walk, had been found on the floor of his room at the extended care facility, raving that there were people out to get him. He was taken to the emergency room at the Waterbury Hospital in Connecticut, where he was diagnosed with a urinary tract infection and admitted to the hospital for treatment. Doctors thought his delirium was caused by the infection, but after 24 hours, despite receiving the appropriate antibiotics, the patient remained disoriented and frightened.

A Sister’s Visit:

The man’s sister came to visit him on his second day in the hospital. As she walked into the room she was immediately struck by her brother’s distress.

“Get me out of here!” the man shouted from his hospital bed. “They are coming to get me. I gotta get out of here!”

His brown eyes darted from side to side as if searching for his would-be attackers. His arms and legs shook with fear. He looked terrified.

For the past few months, the man had been in and out of the hospital, but he had been getting better — at least he had been improving the last time his sister saw him, the week before. She hurried into the bustling hallway and found a nurse. “What the hell is going on with my brother?” she demanded.

A Long Series of Illnesses:

Three months earlier, the patient had been admitted to that same hospital with delirium tremens. After years of alcohol abuse, he had suddenly stopped drinking a couple of days before, and his body was wracked by the sudden loss of the chemical he had become addicted to. He’d spent an entire week in the hospital but finally recovered. He was sent home, but he didn’t stay there for long.

The following week, when his sister hadn’t heard from him for a couple of days, she forced her way into his home. There she found him, unconscious, in the basement, at the bottom of his staircase. He had fallen, and it looked as if he may have been there for two, possibly three, days. He was close to death. Indeed, in the ambulance on the way to the hospital, his heart had stopped. Rapid action by the E.M.T.’s brought his heart back to life, and he made it to the hospital.

There the extent of the damage became clear. The man’s kidneys had stopped working, and his body chemistry was completely out of whack. He had a severe concussion. And he’d had a heart attack.

He remained in the intensive care unit for nearly three weeks, and in the hospital another two weeks. Even after these weeks of care and recovery, the toll of his injury was terrible. His kidneys were not working, so he required dialysis three times a week. He had needed a machine to help him breathe for so long that he now had to get oxygen through a hole that had been cut into his throat. His arms and legs were so weak that he could not even lift them, and because he was unable even to swallow, he had to be fed through a tube that went directly into his stomach.

Finally, after five weeks in the hospital, he was well enough to be moved to a short-term rehabilitation hospital to complete the long road to recovery. But he was still far from healthy. The laughing, swaggering, Harley-riding man his sister had known until that terrible fall seemed a distant memory, though she saw that he was slowly getting better. He had even started to smile and make jokes. He was confident, he had told her, that with a lot of hard work he could get back to normal. So was she; she knew he was tough.

Back to the Hospital:

The patient had been at the rehab facility for just over two weeks when the staff noticed a sudden change in him. He had stopped smiling and was no longer making jokes. Instead, he talked about people that no one else could see. And he was worried that they wanted to harm him. When he remained confused for a second day, they sent him to the emergency room.

You can see the records from that E.R. visit here.

The man told the E.R. doctor that he knew he was having hallucinations. He thought they had started when he had begun taking a pill to help him sleep a couple of days earlier. It seemed a reasonable explanation, since the medication was known to cause delirium in some people. The hospital psychiatrist took him off that medication and sent him back to rehab that evening with a different sleeping pill.

Back to the Hospital, Again:

Two days later, the patient was back in the emergency room. He was still seeing things that weren’t there, but now he was quite confused as well. He knew his name but couldn’t remember what day or month it was, or even what year. And he had no idea where he was, or where he had just come from.

When the medical team saw the patient after he had been admitted, he was unable to provide any useful medical history. His medical records outlined his earlier hospitalizations, and records from the nursing home filled in additional details. The patient had a history of high blood pressure, depression and alcoholism. He was on a long list of medications. And he had been confused for the past several days.

On examination, he had no fever, although a couple of hours earlier his temperature had been 100.0 degrees. His heart was racing, and his blood pressure was sky high. His arms and legs were weak and swollen. His legs were shaking, and his reflexes were very brisk. Indeed, when his ankle was flexed suddenly, it continued to jerk back and forth on its own three or four times before stopping, a phenomenon known as clonus.

His labs were unchanged from the previous visit except for his urine, which showed signs of a serious infection. A CT scan of the brain was unremarkable, as was a chest X-ray. He was started on an intravenous antibiotic to treat the infection. The thinking was that perhaps the infection was causing the patient’s confusion.

You can see the notes from that second hospital visit here.

His sister had come to visit him the next day, when he was as confused as he had ever been. He was now trembling all over and looked scared to death, terrified. He was certain he was being pursued.

That is when she confronted the nurse, demanding to know what was going on with her brother. The nurse didn’t know. No one did. His urinary tract infection was being treated with antibiotics, but he continued to have a rapid heart rate and elevated blood pressure, along with terrifying hallucinations.

Solving the Mystery:

Can you figure out why this man was so confused and tremulous? I have provided you with all the data available to the doctor who made the diagnosis. The case is not easy — that is why it is here. I’ll post the answer on Friday.

Friday Feb. 8 4:13 p.m. | Updated Thanks for all your responses. You can read about the winner at “Think Like a Doctor: A Confused and Terrified Patient Solved.”

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Rules and Regulations: Post your questions and diagnosis in the comments section below.. The correct answer will appear Friday on Well. The winner will be contacted. Reader comments may also appear in a coming issue of The New York Times Magazine.

Correction: The patient’s eyes were brown, not blue.

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Daniel Doctoroff Enlists Bloomberg in A.L.S. Research

Nicole Bengiveno/The New York Times

Daniel L. Doctoroff, second from right, chief executive of Bloomberg L.P., at Columbia University’s Motor Neuron Center.

Daniel L. Doctoroff watched in pain as his father developed a limp one day, was found to have Lou Gehrig’s disease, and died within two years. Then an uncle also developed symptoms of the same disease, and died soon after.

Now Mr. Doctoroff, like many other relatives of Lou Gehrig’s disease victims, worries that he or his children may someday develop the illness.

But unlike many, he is in a position to try to do something about it. At a time when scientists are making rapid gains in the genetic roots of many diseases, Mr. Doctoroff, a former deputy mayor and private equity investor, is working with Mayor Michael R. Bloomberg and a private equity director, David M. Rubenstein, to put together a $25 million package of donations to support research to try to cure this rare and usually fatal degenerative neurological illness.

“This is a devastating disease,” Mr. Doctoroff said in an interview this week in the glass high-rise on the Upper East Side that houses Bloomberg L.P., the mayor’s media and financial information company, where Mr. Doctoroff is now chief executive. “Up to now, there’s been basically no hope. I have the resources, and I think it’s my obligation to do that.”

The gift is part of a wave of investment based on the booming field of genomic analysis. The money will go to a project called Target A.L.S., a consortium of at least 18 laboratories, including ones at Columbia and at Johns Hopkins, the mayor’s alma mater, working to find biological “targets,” like gene mutations, and the biochemical changes they cause in the spinal cord, that could be used to test potential drug therapies for the disease, formally known as amyotrophic lateral sclerosis.

It comes on top of a previous $15 million gift by Mr. Doctoroff, Bloomberg Philanthropies and other donors. By comparison, the National Institutes of Health, the single largest source of research financing for the disease, expects to give $44 million in 2013.

This is not Mr. Bloomberg’s first time supporting charitable causes that are dear to his close associates. The mayor quietly gave at least $1 million to put the name of his top deputy mayor, Patricia E. Harris, on a new academic center at her alma mater, Franklin & Marshall College in Lancaster, Pa.

Mr. Doctoroff said the conversation about A.L.S. in which he got Mr. Bloomberg involved “lasted about five seconds.” He declined to say what share of the money each of the three donors was giving.

Mr. Rubenstein, a founder of the Carlyle Group, said Wednesday that he had long been fascinated with A.L.S. because of its association with Gehrig, the baseball player who died of it. He wondered why more than 70 years later so little progress had been made in treating it.

He said he jumped at the chance to join in because he thought that A.L.S. research was underfinanced owing to the rarity of the disease, and that even a small amount of money could make a big difference.

In the Bloomberg administration, where he was deputy mayor for economic development and rebuilding from 2002 to 2008, Mr. Doctoroff was best known for his dogged — and ultimately dashed — attempt to bring the 2012 Olympics to New York City. (London got the Games.) Now that he has left City Hall, he no longer rides his bike to work — he says the 2.6-mile route from the Upper West Side to his office is too short — but he sometimes runs.

At Bloomberg, he sits in front of a conference room with walls of hot-pink glass, while carp swim in a giant fish tank nearby. He keeps no family photos or other personal mementos on his desk, and talking about his family’s disease history does not seem easy for him.

A.L.S. is rare, with about 2 new cases diagnosed a year per 100,000 people, according to the A.L.S. Association. A vast majority of cases are “sporadic,” in people who have no family history, while only 5 to 10 percent of cases are inherited. There appear to be no racial, ethnic or socioeconomic predispositions.

There is some speculation about environmental factors, like exposure to toxic chemicals and high physical activity that athletes might endure, “but nothing firm,” said Christopher E. Henderson, a researcher at Columbia and the Target A.L.S. project’s scientific director. Some researchers suspect a link between A.L.S. and head trauma suffered by professional football players.

Mr. Doctoroff’s father, Martin, an appeals court judge in Michigan, received the diagnosis in 2000 and died in 2002. One of Martin Doctoroff’s brothers, Michael, was found to have the disease in 2009 and died in 2010.

“When my father contracted the disease and passed away, it was very easy to chalk it up to bad luck,” Mr. Doctoroff said. “When my uncle got it, it obviously had broader implications.”

Given his family history, Mr. Doctoroff estimates that there is a 50-50 chance that he has the gene, C9orf72, that could lead to A.L.S. But he has chosen not to be tested, which would have implications not just for him but for his three children. “It’s very personal, but I’m not sure that I want to know,” he said.

Even when family members develop the disease, it can occur at vastly different ages, so he could still be in suspense even after testing. “Assuming you have the gene, you don’t know when you would actually get the disease,” he said. His uncle was 71. His father was 66. He is now 54.

Sheelagh McNeill contributed reporting.

This article has been revised to reflect the following correction:

Correction: February 8, 2013

Because of an editing error, a picture caption on Thursday with an article about efforts by Daniel L. Doctoroff, a former deputy mayor of New York, to research Lou Gehrig’s disease misstated his title at Bloomberg L.P. in some editions. He is the chief executive, not the executive director.

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Personal Health: Effective Addiction Treatment

Countless people addicted to drugs, alcohol or both have managed to get clean and stay clean with the help of organizations like Alcoholics Anonymous or the thousands of residential and outpatient clinics devoted to treating addiction.

But if you have failed one or more times to achieve lasting sobriety after rehab, perhaps after spending tens of thousands of dollars, you’re not alone. And chances are, it’s not your fault.

Of the 23.5 million teenagers and adults addicted to alcohol or drugs, only about 1 in 10 gets treatment, which too often fails to keep them drug-free. Many of these programs fail to use proven methods to deal with the factors that underlie addiction and set off relapse.

According to recent examinations of treatment programs, most are rooted in outdated methods rather than newer approaches shown in scientific studies to be more effective in helping people achieve and maintain addiction-free lives. People typically do more research when shopping for a new car than when seeking treatment for addiction.

A groundbreaking report published last year by the National Center on Addiction and Substance Abuse at Columbia University concluded that “the vast majority of people in need of addiction treatment do not receive anything that approximates evidence-based care.” The report added, “Only a small fraction of individuals receive interventions or treatment consistent with scientific knowledge about what works.”

The Columbia report found that most addiction treatment providers are not medical professionals and are not equipped with the knowledge, skills or credentials needed to provide the full range of evidence-based services, including medication and psychosocial therapy. The authors suggested that such insufficient care could be considered “a form of medical malpractice.”

The failings of many treatment programs — and the comprehensive therapies that have been scientifically validated but remain vastly underused — are described in an eye-opening new book, “Inside Rehab,” by Anne M. Fletcher, a science writer whose previous books include the highly acclaimed “Sober for Good.”

“There are exceptions, but of the many thousands of treatment programs out there, most use exactly the same kind of treatment you would have received in 1950, not modern scientific approaches,” A. Thomas McLellan, co-founder of the Treatment Research Institute in Philadelphia, told Ms. Fletcher.

Ms. Fletcher’s book, replete with the experiences of treated addicts, offers myriad suggestions to help patients find addiction treatments with the highest probability of success.

Often, Ms. Fletcher found, low-cost, publicly funded clinics have better-qualified therapists and better outcomes than the high-end residential centers typically used by celebrities like Britney Spears and Lindsay Lohan. Indeed, their revolving-door experiences with treatment helped prompt Ms. Fletcher’s exhaustive exploration in the first place.

In an interview, Ms. Fletcher said she wanted to inform consumers “about science-based practices that should form the basis of addiction treatment” and explode some of the myths surrounding it.

One such myth is the belief that most addicts need to go to a rehab center.

“The truth is that most people recover (1) completely on their own, (2) by attending self-help groups, and/or (3) by seeing a counselor or therapist individually,” she wrote.

Contrary to the 30-day stint typical of inpatient rehab, “people with serious substance abuse disorders commonly require care for months or even years,” she wrote. “The short-term fix mentality partially explains why so many people go back to their old habits.”

Dr. Mark Willenbring, a former director of treatment and recovery research at the National Institute for Alcohol Abuse and Alcoholism, said in an interview, “You don’t treat a chronic illness for four weeks and then send the patient to a support group. People with a chronic form of addiction need multimodal treatment that is individualized and offered continuously or intermittently for as long as they need it.”

Dr. Willenbring now practices in St. Paul, where he is creating a clinic called Alltyr “to serve as a model to demonstrate what comprehensive 21st century treatment should look like.”

“While some people are helped by one intensive round of treatment, the majority of addicts continue to need services,” Dr. Willenbring said. He cited the case of a 43-year-old woman “who has been in and out of rehab 42 times” because she never got the full range of medical and support services she needed.

Dr. Willenbring is especially distressed about patients who are treated for opioid addiction, then relapse in part because they are not given maintenance therapy with the drug Suboxone.

“We have some pretty good drugs to help people with addiction problems, but doctors don’t know how to use them,” he said. “The 12-step community doesn’t want to use relapse-prevention medication because they view it as a crutch.”

Before committing to a treatment program, Ms. Fletcher urges prospective clients or their families to do their homework. The first step, she said, is to get an independent assessment of the need for treatment, as well as the kind of treatment needed, by an expert who is not affiliated with the program you are considering.

Check on the credentials of the program’s personnel, who should have “at least a master’s degree,” Ms. Fletcher said. If the therapist is a physician, he or she should be certified by the American Board of Addiction Medicine.

Does the facility’s approach to treatment fit with your beliefs and values? If a 12-step program like A.A. is not right for you, don’t choose it just because it’s the best known approach.

Meet with the therapist who will treat you and ask what your treatment plan will be. “It should be more than movies, lectures or three-hour classes three times a week,” Ms. Fletcher said. “You should be treated by a licensed addiction counselor who will see you one-on-one. Treatment should be individualized. One size does not fit all.”

Find out if you will receive therapy for any underlying condition, like depression, or a social problem that could sabotage recovery. The National Institute on Drug Abuse states in its Principles of Drug Addiction Treatment, “To be effective, treatment must address the individual’s drug abuse and any associated medical, psychological, social, vocational, and legal problems.”

Look for programs using research-validated techniques, like cognitive behavioral therapy, which helps addicts recognize what prompts them to use drugs or alcohol, and learn to redirect their thoughts and reactions away from the abused substance.

Other validated treatment methods include Community Reinforcement and Family Training, or Craft, an approach developed by Robert J. Meyers and described in his book, “Get Your Loved One Sober,” with co-author Brenda L. Wolfe. It helps addicts adopt a lifestyle more rewarding than one filled with drugs and alcohol.

This is the first of two articles on addiction treatment.

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Question Mark: Women’s Eggs Diminish With Age

Baby girls enter the world with enough of them to populate perhaps 40 small cities. A dozen or so years later, the first will make a debut of its own. And in the months and years to come, others will appear regularly, sometimes greeted with relief, other times with disappointment, perhaps most often with a touch of annoyance.

Abdullah Pope/Agence France-Presse — Getty Images

Not women's eggs, obviously.

Now, for women in the baby boom generation, they may be coming more sporadically, or not at all, signaling unmistakably that one time of life is over, and another begun. But what happened to all those eggs?

When girls are born, they have about two million eggs in their ovaries, nestled in fluid-filled cavities called follicles. That may sound like a lot, but consider that months earlier, when they were still in utero, they may have had as many as six or seven million eggs. Those eggs are still immature, and the proper name for them, by the way, is oocytes (rhymes with: nothing).

The first eggs to bite the dust were those in the fetus, which waste away. And by the time a girl reaches puberty, most of her remaining eggs have also deteriorated and been reabsorbed. If that sounds ominously like something from a “Star Trek” episode about the Borg, imagine if all those eggs had to take the customary path out of the body.

Even with the Great Egg Disappearance, girls enter puberty with many more than they will use, 300,000 or more. Each month, the body produces a hormone, FSH, which stimulates the follicles to prepare an egg for maturation and release.

With eggs backed up like bowling balls on a busy Saturday night at the lanes, the ovaries can afford to be a little wasteful, and as many as several dozen follicles are called into action. Then a single mature egg — usually, anyway — gets the tap on the shoulder and begins its travels to the uterus.

As for the maturing eggs that didn’t make the grade, there is no second chance. But they do not go out on their own. “Each month you probably lose a thousand or so,” said Dr. James T. Breeden, president of the American Congress of Obstetrics and Gynecology. “There’s just a natural death of them.”

For all the eggs a woman begins with, in the end only about 400 will go through ovulation. While men produce sperm throughout their lives, over time the number of eggs declines, and they disappear with increasing frequency the decade or so before menopause. Those that remain may decline in quality. “When you have a thousand or less within the ovaries, you’re thought to have undergone menopause,” said Dr. Mitchell Rosen, the director of the Fertility Preservation Center at the University of California, San Francisco.

It’s true that women make far more eggs than they end up using, but men should not pass judgment. “They produce millions of sperm, millions,” Dr. Rosen said. “The whole process is not the most efficient in the world.”

Questions about aging? E-mail boomerwhy@nytimes.com

Booming: Living Through the Middle Ages offers news and commentary about baby boomers, anchored by Michael Winerip. You can follow Booming via RSS here or visit nytimes.com/booming. You can reach us by e-mail at booming@nytimes.com.

This article has been revised to reflect the following correction:

Correction: February 5, 2013

An earlier version of this article incorrectly described estrogen levels at the time of ovulation. They rise, rather than fall.

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Well: Expressing the Inexpressible

When Kyle Potvin learned she had breast cancer at the age of 41, she tracked the details of her illness and treatment in a journal. But when it came to grappling with issues of mortality, fear and hope, she found that her best outlet was poetry.

How I feared chemo, afraid
It would change me.
It did.
Something dissolved inside me.
Tears began a slow drip;
I cried at the news story
Of a lost boy found in the woods …
At the surprising beauty
Of a bright leaf falling
Like the last strand of hair from my head

Ms. Potvin, now 47 and living in Derry, N.H., recently published “Sound Travels on Water” (Finishing Line Press), a collection of poems about her experience with cancer. And she has organized the Prickly Pear Poetry Project, a series of workshops for cancer patients.

“The creative process can be really healing,” Ms. Potvin said in an interview. “Loss, mortality and even hopefulness were on my mind, and I found that through writing poetry I was able to express some of those concepts in a way that helped me process what I was thinking.”

In April, the National Association for Poetry Therapy, whose members include both medical doctors and therapists, is to hold a conference in Chicago with sessions on using poetry to manage pain and to help adolescents cope with bullying. And this spring, Tasora Books will publish “The Cancer Poetry Project 2,” an anthology of poems written by patients and their loved ones.

Dr. Rafael Campo, an associate professor of medicine at Harvard, says he uses poetry in his practice, offering therapy groups and including poems with the medical forms and educational materials he gives his patients.

“It’s always striking to me how they want to talk about the poems the next time we meet and not the other stuff I give them,” he said. “It’s such a visceral mode of expression. When our bodies betray us in such a profound way, it can be all the more powerful for patients to really use the rhythms of poetry to make sense of what is happening in their bodies.”

On return visits, Dr. Campo’s patients often begin by discussing a poem he gave them — for example, “At the Cancer Clinic,” by Ted Kooser, from his collection “Delights & Shadows” (Copper Canyon Press, 2004), about a nurse holding the door for a slow-moving patient.

How patient she is in the crisp white sails
of her clothes. The sick woman
peers from under her funny knit cap
to watch each foot swing scuffing forward
and take its turn under her weight.
There is no restlessness or impatience
or anger anywhere in sight. Grace
fills the clean mold of this moment
and all the shuffling magazines grow still.

In Ms. Potvin’s case, poems related to her illness were often spurred by mundane moments, like seeing a neighbor out for a nightly walk. Here is “Tumor”:

My neighbor walks
For miles each night.
A mantra drives her, I imagine
As my boys’ chant did
The summer of my own illness:
“Push, Mommy, push.”
Urging me to wind my sore feet
Winch-like on a rented bike
To inch us home.
I couldn’t stop;
Couldn’t leave us
Miles from the end.

Karin Miller, 48, of Minneapolis, turned to poetry 15 years ago when her husband developed testicular cancer at the same time she was pregnant with their first child.

Her husband has since recovered, and Ms. Miller has reviewed thousands of poems by cancer patients and their loved ones to create the “Cancer Poetry Project” anthologies. One poem is “Hymn to a Lost Breast,” by Bonnie Maurer.

Oh let it fly
let it fling
let it flip like a pancake in the air
let it sing: what is the song
of one breast flapping?

Another is “Barn Wish” by Kim Knedler Hewett.

I sit where you can’t see me
Listening to the rustle of papers and pills in the other room,
Wondering if you can hear them.
Let’s go back to the barn, I whisper.
Let’s turn on the TV and watch the Bengals lose.
Let’s eat Bill’s Doughnuts and drink Pepsi.
Anything but this.

Ms. Miller has asked many of her poets to explain why they find poetry healing. “They say it’s the thing that lets them get to the core of how they are feeling,” she said. “It’s the simplicity of poetry, the bare bones of it, that helps them deal with their fears.”

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Have you written a poem about cancer? Please share them with us in the comments section below.

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Phys Ed: Helmets for Ski and Snowboard Safety

Phys Ed

Gretchen Reynolds on the science of fitness.

Recently, researchers from the department of sport science at the University of Innsbruck in Austria stood on the slopes at a local ski resort and trained a radar gun on a group of about 500 skiers and snowboarders, each of whom had completed a lengthy personality questionnaire about whether he or she tended to be cautious or a risk taker.

The researchers had asked their volunteers to wear their normal ski gear and schuss or ride down the slopes at their preferred speed. Although they hadn’t informed the volunteers, their primary aim was to determine whether wearing a helmet increased people’s willingness to take risks, in which case helmets could actually decrease safety on the slopes.

What they found was reassuring.

To many of us who hit the slopes with, in my case, literal regularity — I’m an ungainly novice snowboarder — the value of wearing a helmet can seem self-evident. It protects your head from severe injury. During the Big Air finals at the Winter X Games in Aspen, Colo., this past weekend, for instance, Halldor Helgason, a 23-year-old Icelandic snowboarder, over-rotated on a triple back flip, landed headfirst on the snow and was briefly knocked unconscious. But like the other competitors he was wearing a helmet, and didn’t fracture his skull.

Indeed, studies have concluded that helmets reduce the risk of a serious head injury by as much as 60 percent. But a surprising number of safety experts and snowsport enthusiasts remain unconvinced that helmets reduce overall injury risk.

Why? A telling 2009 survey of ski patrollers from across the country found that 77 percent did not wear helmets because they worried that the headgear could reduce their peripheral vision, hearing and response times, making them slower and clumsier. In addition, many worried that if they wore helmets, less-adept skiers and snowboarders might do likewise, feel invulnerable and engage in riskier behavior on the slopes.

In the past several years, a number of researchers have tried to resolve these concerns, for or against helmets. And in almost all instances, helmets have proved their value.

In the Innsbruck speed experiment, the researchers found that people whom the questionnaires showed to be risk takers skied and rode faster than those who were by nature cautious. No surprise.

But wearing a helmet did not increase people’s speed, as would be expected if the headgear encouraged risk taking. Cautious people were slower than risk-takers, whether they wore helmets or not; and risk-takers were fast, whether their heads were protected or bare.

Interestingly, the skiers and riders who were the most likely, in general, to wear a helmet were the most expert, the men and women with the most talent and hours on the slopes. Experience seemed to have taught them the value of a helmet.

Off the slopes, other new studies have brought skiers and snowboarders into the lab to test their reaction times and vision with and without helmets. Peripheral vision and response times are a serious safety concern in a sport where skiers and riders rapidly converge from multiple directions.

But when researchers asked snowboarders and skiers to wear caps, helmets, goggles or various combinations of each for a 2011 study and then had them sit before a computer screen and press a button when certain images popped up, they found that volunteers’ peripheral vision and reaction times were virtually unchanged when they wore a helmet, compared with wearing a hat. Goggles slightly reduced peripheral vision and increased response times. But helmets had no significant effect.

Even when researchers added music, testing snowboarders and skiers wearing Bluetooth-audio equipped helmets, response times did not increase significantly from when they wore wool caps.

So why do up to 40 percent of skiers and snowboarders still avoid helmets?

“The biggest reason, I think, is that many people never expect to fall,” said Dr. Adil H. Haider, a trauma surgeon and associate professor of surgery at Johns Hopkins University in Baltimore and co-author of a major new review of studies related to winter helmet use. “That attitude is especially common in people, like me, who are comfortable on blue runs but maybe not on blacks, and even more so in beginners.”

But a study published last spring detailing snowboarding injuries over the course of 18 seasons at a Vermont ski resort found that the riders at greatest risk of hurting themselves were female beginners. I sympathize.

The take-away from the growing body of science about ski helmets is in fact unequivocal, Dr. Haider said. “Helmets are safe. They don’t seem to increase risk taking. And they protect against serious, even fatal head injuries.”

The Eastern Association for the Surgery of Trauma, of which Dr. Haider is a member, has issued a recommendation that “all recreational skiers and snowboarders should wear safety helmets,” making them the first medical group to go on record advocating universal helmet use.

Perhaps even more persuasive, Dr. Haider has given helmets to all of his family members and colleagues who ski or ride. “As a trauma surgeon, I know how difficult it is to fix a brain,” he said. “So everyone I care about wears a helmet.”

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Ferrol Sams, Doctor Turned Novelist, Dies at 90

Ferrol Sams, a country doctor who started writing fiction in his late 50s and went on to win critical praise and a devoted readership for his humorous and perceptive novels and stories that drew on his medical practice and his rural Southern roots, died on Tuesday at his home in Fayetteville, Ga. He was 90.

The cause, said his son Ferrol Sams III, also a doctor, was that he was “slap wore out.”

“He lived a full life,” his son said. “He didn’t leave anything in the tank.”

Dr. Sams grew up on a farm in the rural Piedmont area of Georgia, seven mud-road miles from the nearest town. He was a boy during the Depression; books meant escape and discovery. He read “Robinson Crusoe,” then Mark Twain and Charles Dickens. One of his English professors at Mercer University, in Macon, suggested he consider a career in writing, but he chose another route to examining the human condition: medical school.

When he was 58 — after he had served in World War II, started a medical practice with his wife, raised his four children and stopped devoting so much of his mornings to preparing lessons for Sunday school at the Methodist church — he began writing “Run With the Horsemen,” a novel based on his youth. It was published in 1982.

“In the beginning was the land,” the book begins. “Shortly thereafter was the father.”

In The New York Times Book Review, the novelist Robert Miner wrote, “Mr. Sams’s approach to his hero’s experiences is nicely signaled in these two opening sentences.”

He added: “I couldn’t help associating the gentility, good-humored common sense and pace of this novel with my image of a country doctor spinning yarns. The writing is elegant, reflective and amused. Mr. Sams is a storyteller sure of his audience, in no particular hurry, and gifted with perfect timing.”

Dr. Sams modeled the lead character in “Run With the Horsemen,” Porter Osborne Jr., on himself, and featured him in two more novels, “The Whisper of the River” and “When All the World Was Young,” which followed him into World War II.

Dr. Sams also wrote thinly disguised stories about his life as a physician. In “Epiphany,” he captures the friendship that develops between a literary-minded doctor frustrated by bureaucracy and a patient angry over past racism and injustice.

Ferrol Sams Jr. was born Sept. 26, 1922, in Woolsey, Ga. He received a bachelor’s degree from Mercer in 1942 and his medical degree from Emory University in 1949. In his addition to his namesake, survivors include his wife, Dr. Helen Fletcher Sams; his sons Jim and Fletcher; a daughter, Ellen Nichol; eight grandchildren; and nine great-grandchildren.

Some critics tired of what they called the “folksiness” in Dr. Sams’s books. But he did not write for the critics, he said. In an interview with the Georgia Writers Hall of Fame, Dr. Sams was asked what audience he wrote for. Himself, he said.

“If you lose your sense of awe, or if you lose your sense of the ridiculous, you’ve fallen into a terrible pit,” he added. “The only thing that’s worse is never to have had either.”

This article has been revised to reflect the following correction:

Correction: February 2, 2013

An earlier version of this obituary misstated the town in which Mr. Sams died. It was Fayetteville, Ga., not Lafayette, Ga.

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Birth Control Rule Altered to Allay Religious Objections

WASHINGTON — The Obama administration on Friday proposed yet another compromise to address strenuous objections from religious organizations about a policy requiring health insurance plans to provide free contraceptives, but the change did not end the political furor or legal fight over the issue.

The proposal could expand the number of groups that do not need to pay directly for birth control coverage, encompassing not only churches and other religious organizations, but also some religiously affiliated hospitals, universities and social service agencies. Health insurance companies would pay for the coverage.

The latest proposed change is the third in the last 15 months, all announced on Fridays, as President Obama has struggled to balance women’s rights, health care and religious liberty. Legal experts said the fight could end up in the Supreme Court.

Kathleen Sebelius, the secretary of health and human services, said the proposal would guarantee free coverage of birth control “while respecting religious concerns.”

But Kyle Duncan, the general counsel of the Becket Fund for Religious Liberty in Washington, which is representing employers in eight lawsuits, said the litigation would continue. “Today’s proposed rule does nothing to protect the religious freedom of millions of Americans,” Mr. Duncan said.

Religious groups dissatisfied with the new proposal want a broader, more explicit exemption for religious organizations and protection for secular businesses owned by people with religious objections to contraceptive coverage.

The tortured history of the rule has played out in several chapters. The Obama administration first issued standards requiring insurers to cover contraceptives for women in August 2011, less than a month after receiving recommendations to that effect from the National Academy of Sciences. In January 2012, the administration rejected a broad exemption sought by the Roman Catholic Church for insurance provided by Catholic hospitals, colleges and charities. After a firestorm of criticism from Catholic bishops and Republican lawmakers, the administration offered a possible compromise that February. But it left many questions unanswered and did not say how coverage would be provided for self-insured religious organizations.

Under the new proposal, churches and nonprofit religious organizations that object to providing birth control coverage on religious grounds would not have to pay for it.

Female employees could get free contraceptive coverage through a separate plan that would be provided by a health insurer. Institutions objecting to the coverage would not pay for the contraceptives.

Chiquita Brooks-LaSure, who helped develop the proposal as deputy director of the federal office that regulates health insurance, said: “Under the proposed rule, insurance companies — not churches or other religious organizations — will cover contraceptive services. No nonprofit religious institution will be forced to pay for or provide contraceptive coverage, and churches and houses of worship are specifically exempt.”

Moreover, she said, “Nonprofit religious organizations like universities, hospitals or charities with religious objections won’t have to arrange, contract or pay for coverage of these services for their employees or students.”

But some of the lawsuits objecting to the plan have been filed by businesses owned by people who say they have religious reasons for not wanting to provide contraceptive coverage. Under the proposed rule, “for-profit secular employers” would have to provide birth control coverage to employees, even if the business owners had a religious objection to the idea.

Insurers said they were studying the proposal, but had questions about how it would work. Many insurers asked where they would get the money to pay for birth control pills if — as the proposed rule says — they cannot “impose any premium, fee or other charge” for the coverage. The 2010 health care law generally requires employers to provide women with coverage at no cost for “preventive care and screenings,” which the administration says must include contraceptives for women under most health plans.

The administration says employers must cover sterilization and the full range of contraceptive methods approved by the Food and Drug Administration, including emergency contraceptive pills, like those known as ella and Plan B One-Step. Employers that do not provide such coverage will be subject to financial penalties.

The proposed rule is somewhat ambiguous about exactly who would pay the cost of contraceptive coverage.

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Hip Implant’s Risks Inadequately Assessed, DePuy Report Found in 2010

A review conducted internally by Johnson & Johnson soon after it recalled a troubled hip implant found that the company had not adequately assessed the device’s potential risks before it was used in more than 90,000 patients, court testimony on Thursday showed.

The engineering report, which was done in 2010, also found that Johnson & Johnson’s orthopedic unit had used inadequate or incorrect standards in trying to assess some of those risks before first selling the implant in 2003. The device at issue — the Articular Surface Replacement, or A.S.R. — proved to be among the most flawed orthopedic devices sold in recent decades.

The report was introduced on Thursday in Los Angeles Superior Court, in the first A.S.R.-related lawsuit to go to trial against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 similar lawsuits have been filed in the United States.

In videotaped testimony shown in court, Jimmy Smith, a compliance manager at DePuy, was asked about the report, and he said it indicated that company officials had not used appropriate engineering controls to try to anticipate the device’s problems.

“They did their job, but they could have done it better,” Mr. Smith said.

Separately, a DePuy engineer, Graham Isaac, testified on Thursday that before selling the A.S.R., the company only tested its performance on laboratory equipment at one angle of implantation.

Depending on the surgical technique and a patient’s build, orthopedic surgeons can implant the cup component of an artificial hip at a variety of angles. And because the A.S.R. had a design flaw, normal variance from the single angle at which DePuy had tested it made it more likely for the joint’s cup and ball components to strike each other, releasing metallic debris inside a patient.

DePuy conducted the post-mortem review of the A.S.R. in November 2010, just three months after it recalled the all-metal implant, but it never released the analysis. It also, apparently, did not conduct a similar review in response to the mounting number of complaints about the device that it received from doctors and others in 2008 and 2009.

Lorie Gawreluk, a spokeswoman for DePuy, said that she could not comment on any details of the lawsuit, but that the company believed that the evidence would show it acted appropriately. The trial’s proceedings were monitored over the Courtroom View Network.

The A.S.R. is projected to fail within five years in about 40 percent of patients who received the implant. That early failure rate, which is expected to grow over time, is many times higher than the failure rate for most hip replacements.

In the post-recall review in 2010, DePuy engineers examined the criteria and “controls,” or standards, that were used nearly a decade earlier when company officials tried to anticipate how the A.S.R. might perform. Because the version of the device that was sold in the United States was never clinically tested in patients, officials used the controls to assess the implant.

Among other things, DePuy officials failed to anticipate that the A.S.R. would have a high rate of wear as a patient moved, even though the control referenced in the device’s records demonstrated “that the product is more likely to experience contact between the head and rim” than competing implants.

In previously recorded testimony presented in court on Wednesday, DePuy’s president, Andrew Ekdahl, was shown an e-mail in which he was warned about the A.S.R.’s problems nearly three years before it was recalled.

Mr. Ekdahl and other DePuy executives have asserted that they acted properly and in a timely fashion to the device’s problems. The company spokeswoman, Ms. Gawreluk, said Mr. Ekdahl would not be made available for an interview.

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During Trial, New Details Emerge on DuPuy Hip

When Johnson & Johnson announced the appointment in 2011 of an executive to head the troubled orthopedics division whose badly flawed artificial hip had been recalled, the company billed the move as a fresh start.

But that same executive, it turns out, had supervised the implant’s introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.

In addition, the executive also held a senior marketing position at a time when Johnson & Johnson decided not to tell officials outside the United States that American regulators had refused to allow sale of a version of the artificial hip in this country.

The details about the involvement of the executive, Andrew Ekdahl, with the all-metal hip implant emerged Wednesday in Los Angeles Superior Court during the trial of a patient lawsuit against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 lawsuits have been filed against DePuy in connection with the device — the Articular Surface Replacement, or A.S.R. — and the Los Angeles case is the first to go to trial.

The information about the depth of Mr. Ekdahl’s involvement with the implant may raise questions about DePuy’s ability to put the A.S.R. episode behind it.

Asked in an e-mail why the company had promoted Mr. Ekdahl, a DePuy spokeswoman, Lorie Gawreluk, said the company “seeks the most accomplished and competent people for the job.”

On Wednesday, portions of Mr. Ekdahl’s videotaped testimony were shown to jurors in the Los Angeles case. Other top DePuy marketing executives who played roles in the A.S.R. development are expected to testify in coming days. Mr. Ekdahl, when pressed in the taped questioning on whether DePuy had recalled the A.S.R. because it was unsafe, repeatedly responded that the company had recalled it “because it did not meet the clinical standards we wanted in the marketplace.”

Before the device’s recall in mid-2010, Mr. Ekdahl and those executives all publicly asserted that the device was performing extremely well. But internal documents that have become public as a result of litigation conflict with such statements.

In late 2008, for example, a surgeon who served as one of DePuy’s top consultants told Mr. Ekdahl and two other DePuy marketing officials that he was concerned about the cup component of the A.S.R. and believed it should be “redesigned.” At the time, DePuy was aggressively promoting the device in the United States as a breakthrough and it was being implanted into thousands of patients.

“My thoughts would be that DePuy should at least de-emphasize the A.S.R. cup while the clinical results are studied,” that consultant, Dr. William Griffin, wrote.

A spokesman for Dr. Griffin said he was not available for comment.

The A.S.R., whose cup and ball components were both made of metal, was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use here in standard hip replacement that used the same cup component as the resurfacing device. Only the standard A.S.R. was sold in the United States; both versions were sold outside the country.

Before the device recall in mid-2010, about 93,000 patients worldwide received an A.S.R., about a third of them in this country. Internal DePuy projections estimate that it will fail in 40 percent of those patients within five years; a rate eight times higher than for many other hip devices.

Mr. Ekdahl testified via tape Wednesday that he had been placed in charge of the 2005 introduction of the standard version of the A.S.R. in this country. Within three years, he and other DePuy executives were receiving reports that the device was failing prematurely at higher than expected rates, apparently because of problems related to the cup’s design, documents disclosed during the trial indicate.

Along with other DePuy executives, he also participated in a meeting that resulted in a proposal to redesign the A.S.R. cup. But that plan was dropped, apparently because sales of the implant had not justified the expense, DePuy documents indicate.

In the face of growing complaints from surgeons about the A.S.R., DePuy officials maintained that the problems were related to how surgeons were implanting the cup, not from any design flaw. But in early 2009, a DePuy executive wrote to Mr. Ekdahl and other marketing officials that the early failures of the A.S.R. resurfacing device and the A.S.R. traditional implant, known as the XL, were most likely design-related.

“The issue seen with A.S.R. and XL today, over five years post-launch, are most likely linked to the inherent design of the product and that is something we should recognize,” that executive, Raphael Pascaud wrote in March 2009.

Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant.

The F.D.A. also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.

DePuy never disclosed the F.D.A. ruling to regulators in other countries where it was still marketing the resurfacing version of the implant.

During a part of that period, Mr. Ekdahl was overseeing sales in Europe and other regions for DePuy. When The Times article appeared last year, he issued a statement, saying that any implication that the F.D.A. had determined there were safety issues with the A.S.R. was “simply untrue.” “This was purely a business decision,” Mr. Ekdahl stated at that time.

This article has been revised to reflect the following correction:

Correction: January 30, 2013

An earlier version of this article, in the summary, described the start of the DePuy trial incorrectly. It began last week, not this week.

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Report Links Rodriguez and Others to Clinic and P.E.D.’s

Investigators for Major League Baseball created an improvised war room in the commissioner’s Park Avenue offices in Manhattan in recent months, mapping out potential evidence that would tie an anti-aging clinic in Coral Gables, Fla., to the possible use of performance-enhancing drugs by some of baseball’s more prominent players. 

But because the investigators cannot compel witnesses to talk, they could do nothing more than scrutinize the clinic. As a result, they found themselves mere spectators Tuesday as a weekly Miami newspaper reported that it had obtained medical records from the clinic that tied a half-dozen players — Alex Rodriguez, Melky Cabrera, Gio Gonzalez, Bartolo Colon, Nelson Cruz and Yasmani Grandal — to the use of banned substances like human growth hormone.

The newspaper, Miami New Times, said it had received the records from a former employee of the clinic, which is now closed, and that they included handwritten notations listing various drugs that were reportedly distributed to various players. At least some of those documents were displayed online by the newspaper. However, the documents have not been independently authenticated, and Rodriguez, the Yankees slugger, and Gonzalez, a standout pitcher for the Washington Nationals, both issued statements denying they had been patients at the clinic.

Anthony Bosch, the operator of the clinic, known as Biogenesis of America, also issued a statement of denial through his lawyer, saying the Miami New Times article was “filled with inaccuracies, innuendos and misstatements in fact.”

“Mr. Bosch vehemently denies the assertions that MLB players such as Alex Rodriguez and Gio Gonzalez were treated or associated with him,” the statement added.

Nevertheless, despite the denials, Major League Baseball, long suspicious of the clinic’s actions, will continue to proceed in the belief that the assertions in the article have merit. Major League Baseball has been particularly curious about Rodriguez, who admitted in 2009 that he used performance enhancers from 2001 to 2003, but who has denied in several meetings with baseball’s investigators that he has done so since.

But what exactly baseball can do about Rodriguez, or any of the other players named, is unclear.

Because the potential evidence does not involve failed drug tests, baseball is back where it has been in the past, seeking perhaps to punish players without having the necessary evidence to do so. In the case of the Biogenesis clinic, baseball’s investigators did travel to Florida to meet with members of the Drug Enforcement Administration, who were taking a close look at the facility.

But whether federal authorities would share with baseball any evidence they develop on the clinic is unclear. In other instances over the last decade, that has not happened.

“If the feds are not going to prosecute this case, it would be much better for us for them to give us some usable evidence like the documents so we can do our job and suspend the players,” a baseball official said. “We could be in discipline hell if that doesn’t happen.”

That official knows that baseball has had little success in suspending players for violating the drug testing program when the players have not actually tested positive. Of the roughly 40 players who have been suspended for violating the testing program since 2005, only a handful have been suspended based on evidence developed by baseball’s investigators or from medical records or court documents.

The most high-profile instance of a suspension without a drug test occurred in 2005 when relief pitcher Jason Grimsley was barred for 50 games after federal authorities unsealed court documents that showed that Grimsley admitted to a federal agent that he had used human growth hormone.

As for the Florida clinic, it has been on the radar of both baseball and the federal government since at least 2009, when investigators uncovered evidence that the slugger Manny Ramirez had received a banned drug from the facility. Ramirez was ultimately suspended 50 games for that infraction.

Last summer, baseball’s investigators began to take another look at the clinic after Cabrera, then leading the National League in hitting as the San Francisco Giants’ starting left fielder, tested positive for elevated testosterone. In the course of that positive test, two people in baseball said, baseball’s investigators uncovered evidence that an employee for Cabrera’s agents, Sam and Seth Levinson, had hatched a cover-up scheme to deceive a baseball arbitrator and have the suspension for the positive drug test thrown out.

Angered, baseball officials began investigating the employee, Juan Nunez, and the Levinsons.

Steve Eder and Alain Delaquérière contributed reporting from New York, and Lizette Alvarez from Miami.

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Personal Health: Keeping Blood Pressure in Check

Since the start of the 21st century, Americans have made great progress in controlling high blood pressure, though it remains a leading cause of heart attacks, strokes, congestive heart failure and kidney disease.

Now 48 percent of the more than 76 million adults with hypertension have it under control, up from 29 percent in 2000.

But that means more than half, including many receiving treatment, have blood pressure that remains too high to be healthy. (A normal blood pressure is lower than 120 over 80.) With a plethora of drugs available to normalize blood pressure, why are so many people still at increased risk of disease, disability and premature death? Hypertension experts offer a few common, and correctable, reasons:

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Jane Brody speaks about hypertension.

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¶ About 20 percent of affected adults don’t know they have high blood pressure, perhaps because they never or rarely see a doctor who checks their pressure.

¶ Of the 80 percent who are aware of their condition, some don’t appreciate how serious it can be and fail to get treated, even when their doctors say they should.

¶ Some who have been treated develop bothersome side effects, causing them to abandon therapy or to use it haphazardly.

¶ Many others do little to change lifestyle factors, like obesity, lack of exercise and a high-salt diet, that can make hypertension harder to control.

Dr. Samuel J. Mann, a hypertension specialist and professor of clinical medicine at Weill-Cornell Medical College, adds another factor that may be the most important. Of the 71 percent of people with hypertension who are currently being treated, too many are taking the wrong drugs or the wrong dosages of the right ones.

Dr. Mann, author of “Hypertension and You: Old Drugs, New Drugs, and the Right Drugs for Your High Blood Pressure,” says that doctors should take into account the underlying causes of each patient’s blood pressure problem and the side effects that may prompt patients to abandon therapy. He has found that when treatment is tailored to the individual, nearly all cases of high blood pressure can be brought and kept under control with available drugs.

Plus, he said in an interview, it can be done with minimal, if any, side effects and at a reasonable cost.

“For most people, no new drugs need to be developed,” Dr. Mann said. “What we need, in terms of medication, is already out there. We just need to use it better.”

But many doctors who are generalists do not understand the “intricacies and nuances” of the dozens of available medications to determine which is appropriate to a certain patient.

“Prescribing the same medication to patient after patient just does not cut it,” Dr. Mann wrote in his book.

The trick to prescribing the best treatment for each patient is to first determine which of three mechanisms, or combination of mechanisms, is responsible for a patient’s hypertension, he said.

¶ Salt-sensitive hypertension, more common in older people and African-Americans, responds well to diuretics and calcium channel blockers.

¶ Hypertension driven by the kidney hormone renin responds best to ACE inhibitors and angiotensin receptor blockers, as well as direct renin inhibitors and beta-blockers.

¶ Neurogenic hypertension is a product of the sympathetic nervous system and is best treated with beta-blockers, alpha-blockers and drugs like clonidine.

According to Dr. Mann, neurogenic hypertension results from repressed emotions. He has found that many patients with it suffered trauma early in life or abuse. They seem calm and content on the surface but continually suppress their distress, he said.

One of Dr. Mann’s patients had had high blood pressure since her late 20s that remained well-controlled by the three drugs her family doctor prescribed. Then in her 40s, periodic checks showed it was often too high. When taking more of the prescribed medication did not result in lasting control, she sought Dr. Mann’s help.

After a thorough work-up, he said she had a textbook case of neurogenic hypertension, was taking too much medication and needed different drugs. Her condition soon became far better managed, with side effects she could easily tolerate, and she no longer feared she would die young of a heart attack or stroke.

But most patients should not have to consult a specialist. They can be well-treated by an internist or family physician who approaches the condition systematically, Dr. Mann said. Patients should be started on low doses of one or more drugs, including a diuretic; the dosage or number of drugs can be slowly increased as needed to achieve a normal pressure.

Specialists, he said, are most useful for treating the 10 percent to 15 percent of patients with so-called resistant hypertension that remains uncontrolled despite treatment with three drugs, including a diuretic, and for those whose treatment is effective but causing distressing side effects.

Hypertension sometimes fails to respond to routine care, he noted, because it results from an underlying medical problem that needs to be addressed.

“Some patients are on a lot of blood pressure drugs — four or five — who probably don’t need so many, and if they do, the question is why,” Dr. Mann said.

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How to Measure Your Blood Pressure

Mistaken readings, which can occur in doctors’ offices as well as at home, can result in misdiagnosis of hypertension and improper treatment. Dr. Samuel J. Mann, of Weill Cornell Medical College, suggests these guidelines to reduce the risk of errors:

¶ Use an automatic monitor rather than a manual one, and check the accuracy of your home monitor at the doctor’s office.

¶ Use a monitor with an arm cuff, not a wrist or finger cuff, and use a large cuff if you have a large arm.

¶ Sit quietly for a few minutes, without talking, after putting on the cuff and before checking your pressure.

¶ Check your pressure in one arm only, and take three readings (not more) one or two minutes apart.

¶ Measure your blood pressure no more than twice a week unless you have severe hypertension or are changing medications.

¶ Check your pressure at random, ordinary times of the day, not just when you think it is high.

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Ariel Sharon Brain Scan Shows Response to Stimuli

JERUSALEM — A brain scan performed on Ariel Sharon, the former Israeli prime minister who had a devastating stroke seven years ago and is presumed to be in a vegetative state, revealed significant brain activity in response to external stimuli, raising the chances that he is able to hear and understand, a scientist involved in the test said Sunday.

Scientists showed Mr. Sharon, 84, pictures of his family, had him listen to a recording of the voice of one of his sons and used tactile stimulation to assess the extent of his brain’s response.

“We were surprised that there was activity in the proper parts of the brain,” said Prof. Alon Friedman, a neuroscientist at Ben-Gurion University of the Negev and a member of the team that carried out the test. “It raises the chances that he hears and understands, but we cannot be sure. The test did not prove that.”

The activity in specific regions of the brain indicated appropriate processing of the stimulations, according to a statement from Ben-Gurion University, but additional tests to assess Mr. Sharon’s level of consciousness were less conclusive.

“While there were some encouraging signs, these were subtle and not as strong,” the statement added.

The test was carried out last week at the Soroka University Medical Center in the southern Israeli city of Beersheba using a state-of-the-art M.R.I. machine and methods recently developed by Prof. Martin M. Monti of the University of California, Los Angeles. Professor Monti took part in the test, which lasted approximately two hours.

Mr. Sharon’s son Gilad said in October 2011 that he believed that his father responded to some requests. “When he is awake, he looks at me and moves fingers when I ask him to,” he said at the time, adding, “I am sure he hears me.”

Professor Friedman said in a telephone interview that the test results “say nothing about the future” but may be of some help to the family and the regular medical staff caring for Mr. Sharon at a hospital outside Tel Aviv.

“There is a small chance that he is conscious but has no way of expressing it,” Professor Friedman said, but he added, “We do not know to what extent he is conscious.”

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Well: Ask Well: Squats for Aging Knees

You are already doing many things right, in terms of taking care of your aging knees. In particular, it sounds as if you are keeping your weight under control. Carrying extra pounds undoubtedly strains knees and contributes to pain and eventually arthritis.

You mention weight training, too, which is also valuable. Sturdy leg muscles, particularly those at the front and back of the thighs, stabilize the knee, says Joseph Hart, an assistant professor of kinesiology and certified athletic trainer at the University of Virginia, who often works with patients with knee pain.

An easy exercise to target those muscles is the squat. Although many of us have heard that squats harm knees, the exercise is actually “quite good for the knees, if you do the squats correctly,” Dr. Hart says. Simply stand with your legs shoulder-width apart and bend your legs until your thighs are almost, but not completely, parallel to the ground. Keep your upper body straight. Don’t bend forward, he says, since that movement can strain the knees. Try to complete 20 squats, using no weight at first. When that becomes easy, Dr. Hart suggests, hold a barbell with weights attached. Or simply clutch a full milk carton, which is my cheapskate’s squats routine.

Straight leg lifts are also useful for knee health. Sit on the floor with your back straight and one leg extended and the other bent toward your chest. In this position, lift the straight leg slightly off the ground and hold for 10 seconds. Repeat 10 to 20 times and then switch legs.

You can also find other exercises that target the knees in this video, “Increasing Knee Stability.”

Of course, before starting any exercise program, consult a physician, especially, Dr. Hart says, if your knees often ache, feel stiff or emit a strange, clicking noise, which could be symptoms of arthritis.

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F.D.A. Panel Recommends Restrictions on Hydrocodone Products Like Vicodin

Trying to stem the scourge of prescription drug abuse, an advisory panel of experts to the Food and Drug Administration voted on Friday to toughen the restrictions on painkillers like Vicodin that contain hydrocodone, the most widely prescribed drugs in the country. 

The recommendation, which the drug agency is likely to follow, would limit access to the drugs by making them harder to prescribe, a major policy change that advocates said could help ease the growing problem of addiction to painkillers, which exploded in the late 1990s and continues to strike hard in communities from Appalachia and the Midwest to New England. 

But at 19 to 10, the vote was far from unanimous, with some opponents expressing skepticism that the change would do much to combat abuse. Oxycodone, another highly abused painkiller and the main ingredient in OxyContin, has been in the more restrictive category since it first came on the market, they pointed out in testimony at a public hearing. They also said the change could create unfair obstacles for patients in chronic pain. 

 Painkillers now take the lives of more Americans than heroin and cocaine combined, and since 2008, drug-induced deaths have outstripped those from traffic accidents. Prescription drugs account for about three-quarters of all drug overdose deaths in the United States, with the number of deaths from painkillers quadrupling since 1999, according to federal data.

The change would have sweeping consequences for doctors, pharmacists and patients. Refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed. Distributors would be required to store the drugs in special vaults.

The vote comes after similar legislation in Congress failed last year, after aggressive lobbying by pharmacists and drugstores.

“This is the federal government saying, ‘We need to tighten the reins on this drug,’ ” said Scott R. Drab, associate professor of pharmacy and therapeutics at the University of Pittsburgh’s School of Pharmacy. “Pulling in the rope is a way to rein in abuse, and, consequently, addiction.”

But at the panel’s two-day hearing at F.D.A. headquarters in Silver Spring, Md., many spoke against the change, including advocates for nursing home patients, who said frail residents with chronic pain would have to make the trip to a doctor’s office. The change would also ban nurse practitioners and physician assistants from prescribing the drugs, making it harder for people in underserved rural areas.

Panelists also cautioned that the change would produce a whack-a-mole effect, pushing up abuse of other drugs, like heroin, which has declined in recent years.

“Many of us are concerned that the more stringent controls will eventually lead to different problems, which may be worse,” said Dr. John Mendelson, a senior scientist at the Addiction and Pharmacology Research Laboratory at the California Pacific Medical Center Research Institute in San Francisco.

The F.D.A. convened the panel, made up of scientists, pain doctors and other experts, after a request by the Drug Enforcement Administration, which contends that the drugs are among the most frequently abused painkillers and should be more tightly controlled.

If the F.D.A. accepts the panel’s recommendation, it will be sent to officials at the Department of Health and Human Services, who will make the final determination. The F.D.A. denied a similar request by the D.E.A. in 2008, but the law enforcement agency requested that the F.D.A. reconsider its position in light of new research and data.

While hydrocodone products are the most widely prescribed painkillers, they make up a minority of deaths, because there is less medication in each tablet than some of the other more restricted drugs, like extended-release oxycodone products, said Dr. Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine in Boston. Oxycodone and methadone products account for about two-thirds of drug overdose deaths, he said, despite accounting for only a fraction of hydrocodone prescriptions.

The importance of Friday’s vote was more symbolic, he said, a message to doctors that they will need to think twice before prescribing hydrocodone, and to patients that the days of “unbridled access” are coming to an end. The tide has been turning against easy opioid prescriptions, as the medical system and federal regulators slowly make adjustments to reduce the potential for abuse.

“It will help shape thinking,” said Dr. Katz, whose clinical research company, Analgesic Solutions, is trying to develop other treatments for pain. “It’s an important marker in the progressively more conservative swing of the pendulum in opioid prescribing.”

He cautioned that patients who need the medications for pain should not suffer inappropriate barriers to access because of the change, a concern that the dissenters shared.  Medical professionals battling the prescription drug abuse epidemic applauded the change.

“This may be the single most important intervention undertaken at the federal level to bring the epidemic under control,” said Dr. Andrew Kolodny, chairman of psychiatry at Maimonides Medical Center in New York and president of Physicians for Responsible Opioid Prescribing, a New York-based advocacy group. “This is about correcting a mistake made 40 years ago that’s had disastrous consequences.”

Testimony at the hearing included emotional appeals from parents who had lost their children to painkiller addiction. Senator Joe Manchin III, a Democrat from West Virginia, a state that has been hit hard by the prescription drug epidemic, pleaded for tougher restrictions.

“When I go back to West Virginia, I hear how easy it is for anybody to get their hands on hydrocodone drugs,” Mr. Manchin said. “For under-age children, these drugs are easier to get than beer or cigarettes.”

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