Showing posts with label Health. Show all posts
Showing posts with label Health. Show all posts

Well: Straining to Hear and Fend Off Dementia

At a party the other night, a fund-raiser for a literary magazine, I found myself in conversation with a well-known author whose work I greatly admire. I use the term “conversation” loosely. I couldn’t hear a word he said. But worse, the effort I was making to hear was using up so much brain power that I completely forgot the titles of his books.

A senior moment? Maybe. (I’m 65.) But for me, it’s complicated by the fact that I have severe hearing loss, only somewhat eased by a hearing aid and cochlear implant.

Dr. Frank Lin, an otolaryngologist and epidemiologist at Johns Hopkins School of Medicine, describes this phenomenon as “cognitive load.” Cognitive overload is the way it feels. Essentially, the brain is so preoccupied with translating the sounds into words that it seems to have no processing power left to search through the storerooms of memory for a response.


Katherine Bouton speaks about her own experience with hearing loss.


A transcript of this interview can be found here.


Over the past few years, Dr. Lin has delivered unwelcome news to those of us with hearing loss. His work looks “at the interface of hearing loss, gerontology and public health,” as he writes on his Web site. The most significant issue is the relation between hearing loss and dementia.

In a 2011 paper in The Archives of Neurology, Dr. Lin and colleagues found a strong association between the two. The researchers looked at 639 subjects, ranging in age at the beginning of the study from 36 to 90 (with the majority between 60 and 80). The subjects were part of the Baltimore Longitudinal Study of Aging. None had cognitive impairment at the beginning of the study, which followed subjects for 18 years; some had hearing loss.

“Compared to individuals with normal hearing, those individuals with a mild, moderate, and severe hearing loss, respectively, had a 2-, 3- and 5-fold increased risk of developing dementia over the course of the study,” Dr. Lin wrote in an e-mail summarizing the results. The worse the hearing loss, the greater the risk of developing dementia. The correlation remained true even when age, diabetes and hypertension — other conditions associated with dementia — were ruled out.

In an interview, Dr. Lin discussed some possible explanations for the association. The first is social isolation, which may come with hearing loss, a known risk factor for dementia. Another possibility is cognitive load, and a third is some pathological process that causes both hearing loss and dementia.

In a study last month, Dr. Lin and colleagues looked at 1,984 older adults beginning in 1997-8, again using a well-established database. Their findings reinforced those of the 2011 study, but also found that those with hearing loss had a “30 to 40 percent faster rate of loss of thinking and memory abilities” over a six-year period compared with people with normal hearing. Again, the worse the hearing loss, the worse the rate of cognitive decline.

Both studies also found, somewhat surprisingly, that hearing aids were “not significantly associated with lower risk” for cognitive impairment. But self-reporting of hearing-aid use is unreliable, and Dr. Lin’s next study will focus specifically on the way hearing aids are used: for how long, how frequently, how well they have been fitted, what kind of counseling the user received, what other technologies they used to supplement hearing-aid use.

What about the notion of a common pathological process? In a recent paper in the journal Neurology, John Gallacher and colleagues at Cardiff University suggested the possibility of a genetic or environmental factor that could be causing both hearing loss and dementia — and perhaps not in that order. In a phenomenon called reverse causation, a degenerative pathology that leads to early dementia might prove to be a cause of hearing loss.

The work of John T. Cacioppo, director of the Social Neuroscience Laboratory at the University of Chicago, also offers a clue to a pathological link. His multidisciplinary studies on isolation have shown that perceived isolation, or loneliness, is “a more important predictor of a variety of adverse health outcomes than is objective social isolation.” Those with hearing loss, who may sit through a dinner party and not hear a word, frequently experience perceived isolation.

Other research, including the Framingham Heart Study, has found an association between hearing loss and another unexpected condition: cardiovascular disease. Again, the evidence suggests a common pathological cause. Dr. David R. Friedland, a professor of otolaryngology at the Medical College of Wisconsin in Milwaukee, hypothesized in a 2009 paper delivered at a conference that low-frequency loss could be an early indication that a patient has vascular problems: the inner ear is “so sensitive to blood flow” that any vascular abnormalities “could be noted earlier here than in other parts of the body.”

A common pathological cause might help explain why hearing aids do not seem to reduce the risk of dementia. But those of us with hearing loss hope that is not the case; common sense suggests that if you don’t have to work so hard to hear, you have greater cognitive power to listen and understand — and remember. And the sense of perceived isolation, another risk for dementia, is reduced.

A critical factor may be the way hearing aids are used. A user must practice to maximize their effectiveness and they may need reprogramming by an audiologist. Additional assistive technologies like looping and FM systems may also be required. And people with progressive hearing loss may need new aids every few years.

Increasingly, people buy hearing aids online or from big-box stores like Costco, making it hard for the user to follow up. In the first year I had hearing aids, I saw my audiologist initially every two weeks for reprocessing and then every three months.

In one study, Dr. Lin and his colleague Wade Chien found that only one in seven adults who could benefit from hearing aids used them. One deterrent is cost ($2,000 to $6,000 per ear), seldom covered by insurance. Another is the stigma of old age.

Hearing loss is a natural part of aging. But for most people with hearing loss, according to the National Institute on Deafness and Other Communication Disorders, the condition begins long before they get old. Almost two-thirds of men with hearing loss began to lose their hearing before age 44. My hearing loss began when I was 30.

Forty-eight million Americans suffer from some degree of hearing loss. If it can be proved in a clinical trial that hearing aids help delay or offset dementia, the benefits would be immeasurable.

“Could we do something to reduce cognitive decline and delay the onset of dementia?” he asked. “It’s hugely important, because by 2050, 1 in 30 Americans will have dementia.

“If we could delay the onset by even one year, the prevalence of dementia drops by 15 percent down the road. You’re talking about billions of dollars in health care savings.”

Should studies establish definitively that correcting hearing loss decreases the potential for early-onset dementia, we might finally overcome the stigma of hearing loss. Get your hearing tested, get it corrected, and enjoy a longer cognitively active life. Establishing the dangers of uncorrected hearing might even convince private insurers and Medicare that covering the cost of hearing aids is a small price to pay to offset the cost of dementia.



Katherine Bouton is the author of the new book, “Shouting Won’t Help: Why I — and 50 Million Other Americans — Can’t Hear You,” from which this essay is adapted.


This post has been revised to reflect the following correction:

Correction: February 12, 2013

An earlier version of this article misstated the location of the Medical College of Wisconsin. It is in Milwaukee, not Madison.

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Catholic Bishops Reject Contraception Compromise



The bishops said they would continue fighting the federal mandate in court.


The administration said the proposal, issued last Friday, would guarantee free employee coverage of birth control “while respecting religious concerns” of organizations that objected to paying or providing for it.


The bishops said the proposal seemed to address part of their concern about the definition of religious employers who could be exempted from the requirement to offer contraceptive coverage at no charge to employees. But they said it did not go far enough and failed to answer many questions, like who would pay for birth control coverage provided to employees of certain nonprofit religious organizations.


“The administration’s proposal maintains its inaccurate distinction among religious ministries,” said Cardinal Timothy M. Dolan of New York, the president of the United States Conference of Catholic Bishops. “It appears to offer second-class status to our first-class institutions in Catholic health care, Catholic education and Catholic charities. The Department of Health and Human Services offers what it calls an ‘accommodation,’ rather than accepting the fact that these ministries are integral to our church and worthy of the same exemption as our Catholic churches.”


The bishops’ statement, issued after they had reviewed President Obama’s proposal for six days, was more moderate and measured than their criticisms of the original rule issued by the White House early last year. Cardinal Dolan said the bishops wanted to work with the administration to find a solution.


The administration had no immediate reaction to the bishops’ statement, other than to say it was not a surprise.


Marcia D. Greenberger, co-president of the National Women’s Law Center, said that 99 percent of women used contraceptives at some point in their lives and that their interests must be considered.


“The health needs, the religious and conscience beliefs of women deserve to be respected and protected,” said Ms. Greenberger, who supports the White House proposal.


Under the latest proposal, churches and nonprofit religious groups that object to providing birth control coverage on religious grounds would not have to pay for it. Women who work for such organizations could get free contraceptive coverage through separate individual health insurance policies. The institution objecting to the coverage would not pay for the contraceptives. Costs would be paid by an insurance company, with the possibility that it could recoup the costs through lower health care expenses resulting in part from fewer births.


The administration refused to grant an exemption or accommodation to secular businesses owned by people who said they objected to contraceptive coverage on religious grounds.


The bishops rallied to the defense of such employers.


“In obedience to our Judeo-Christian heritage,” Cardinal Dolan said, “we have consistently taught our people to live their lives during the week to reflect the same beliefs that they proclaim on the Sabbath. We cannot now abandon them to be forced to violate their morally well-informed consciences.”


Federal courts have issued differing judgments on the legality of the federal rule. The litigation appears likely to end up in the Supreme Court.


Archbishop Charles J. Chaput of Philadelphia said that the administration’s proposal, at first glance, had “struck some people as a modest improvement.” The proposal, he said, appeared to increase the number of religiously affiliated entities that could claim exemption from the requirement.


But on closer examination, the archbishop said, the federal mandate “remains unnecessary, coercive and gravely flawed.”


“The White House has made no concessions to the religious conscience claims of private businesses, and the whole spirit of the ‘compromise’ is minimalist,” Archbishop Chaput said.


In court cases, judges have expressed keen interest in details of the arrangements for contraceptive coverage. The most difficult question, which the administration has yet to resolve, is how coverage will be provided and financed for employees of self-insured faith-based institutions, which serve as both employers and insurers.


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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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In Nigeria, Polio Vaccine Workers Are Killed by Gunmen





At least nine polio immunization workers were shot to death in northern Nigeria on Friday by gunmen who attacked two clinics, officials said.




The killings, with eerie echoes of attacks that killed nine female polio workers in Pakistan in December, represented another serious setback for the global effort to eradicate polio.


Most of the victims were women and were shot in the back of the head, local reports said.


A four-day vaccination drive had just ended in Kano State, where the killings took place, and the vaccinators were in a “mop-up” phase, looking for children who had been missed, said Sarah Crowe, a spokeswoman for the United Nations Children’s Fund, one of the agencies running the eradication campaign.


Dr. Mohammad Ali Pate, Nigeria’s minister of state for health, said in a telephone interview that it was not entirely clear whether the gunmen were specifically targeting polio workers or just attacking the health centers where vaccinators happened to be gathering early in the morning. “Health workers are soft targets,” he said.


No one immediately took responsibility, but suspicion fell on Boko Haram, a militant Islamist group that has attacked police stations, government offices and even a religious leader’s convoy.


Polio, which once paralyzed millions of children, is now down to fewer than 1,000 known cases around the world, and is endemic in only three countries: Nigeria, Pakistan and Afghanistan.


Since September — when a new polio operations center was opened in the capital and Nigeria’s president, Goodluck Jonathan, appointed a special adviser for polio — the country had been improving, said Dr. Bruce Aylward, chief of polio eradication for the World Health Organization. There have been no new cases since Dec. 3.


While vaccinators have not previously been killed in the country, there is a long history of Nigerian Muslims shunning the vaccine.


Ten years ago, immunization was suspended for 11 months as local governors waited for local scientists to investigate rumors that it caused AIDS or was a Western plot to sterilize Muslim girls. That hiatus let cases spread across Africa. The Nigerian strain of the virus even reached Saudi Arabia when a Nigerian child living in hills outside Mecca was paralyzed.


Heidi Larson, an anthropologist at the London School of Hygiene and Tropical Medicine who tracks vaccine issues, said the newest killings “are kind of mimicking what’s going on in Pakistan, and I feel it’s very much prompted by that.”


In a roundabout way, the C.I.A. has been blamed for the Pakistan killings. In its effort to track Osama bin Laden, the agency paid a Pakistani doctor to seek entry to Bin Laden’s compound on the pretext of vaccinating the children — presumably to get DNA samples as evidence that it was the right family. That enraged some Taliban factions in Pakistan, which outlawed vaccination in their areas and threatened vaccinators.


Nigerian police officials said the first shootings were of eight workers early in the morning at a clinic in the Tarauni neighborhood of Kano, the state capital; two or three died. A survivor said the two gunmen then set fire to a curtain, locked the doors and left.


“We summoned our courage and broke the door because we realized they wanted to burn us alive,” the survivor said from her bed at Aminu Kano Teaching Hospital.


About an hour later, six men on three-wheeled motorcycles stormed a clinic in the Haye neighborhood, a few miles away. They killed seven women waiting to collect vaccine.


Ten years ago, Dr. Larson said, she joined a door-to-door vaccination drive in northern Nigeria as a Unicef communications officer, “and even then we were trying to calm rumors that the C.I.A. was involved,” she said. The Iraq and Afghanistan wars had convinced poor Muslims in many countries that Americans hated them, and some believed the American-made vaccine was a plot by Western drug companies and intelligence agencies.


Since the vaccine ruse in Pakistan, she said, “Frankly, now, I can’t go to them and say, ‘The C.I.A. isn’t involved.’ ”


Dr. Pate said the attack would not stop the newly reinvigorated eradication drive, adding, “This isn’t going to deter us from getting everyone vaccinated to save the lives of our children.”


Aminu Abubakar contributed reported from Kano, Nigeria.



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The New Old Age: The Executor's Assistant

I’m serving as executor for my father’s estate, a role few of us are prepared for until we’re playing it, so I was grateful when the mail brought “The American Bar Association Guide to Wills and Estates” — the fourth edition of a handbook the A.B.A. began publishing in 1995.

This is a legal universe, I’m learning, in which every step — even with a small, simple estate that owes no taxes and includes no real estate or trusts — turns out to be at least 30 percent more complicated than expected.

If my dad had been wealthy or owned a business, or if we faced a challenge to his will, I would have turned the whole matter over to an estate lawyer by now. But even then, it would be helpful to know what the lawyer was talking about. The A.B.A. guide would help.

Written with surprising clarity (hey, they’re lawyers), it maps out all kinds of questions and decisions to consider and explains the many ways to leave property to one’s heirs. Updated from the third edition in 2009, the guide not only talks taxes and trusts, but also offers counsel for same-sex couples and unconventional families.

If you want to permit your second husband to live in the family home until he dies, but then guarantee that the house reverts to the children of your first marriage, the guide tells you how a “life estate” works. It explains what is taxable and what isn’t, and discusses how to choose executors and trustees. It lists lots of resources and concludes with an estate-planning checklist.

In general, the A.B.A. intends its guide for the person trying to put his or her affairs in order, more than for family members trying to figure out how to proceed after someone has died. But many of us will play both these parts at some point (and if you are already an executor, or have been, please tell us how that has gone, and mention your state). We’ll need this information.

Editor’s Note: More information about “The American Bar Association Guide to Wills and Estates” can be found here.


Paula Span is the author of “When the Time Comes: Families With Aging Parents Share Their Struggles and Solutions.”

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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.”


Have you written a poem about cancer? Please share them with us in the comments section below.
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The New Old Age Blog: For Women, Reduced Access to Long-Term Care Insurance

“This was a very, very good business for a short time, with people buying long-term care insurance like it was candy in a candy store,’’ said Michael Perry, a vice president at the Opus Advisory Group, a strategic financial planning firm in Purchase, N.Y.

No more. Mr. Perry has sold only one long-term care policy in the last six months and is “backing off from marketing’’ them as he watches this corner of the insurance business contract, raise premiums, tighten eligibility requirements and reduce key benefits. Long-term care insurance is a comparatively new product, launched in the late ’80s, and only now, as claims begin to pour in, have the actual costs to insurers become apparent.

Companies like MetLife, Prudential Financial, Allianz and Berkshire Financial (a subsidiary of Guardian) have stopped selling new policies and are hiking premiums for the ones already in place — up 37 percent, by one estimate, in 2011. Insurers are increasing elimination periods — the period during which a beneficiary must cover his or her own costs — and reducing inflation protection to 3 percent from 5 percent, once customary. They are requiring home visits instead of phone interviews from new applicants, as well as blood tests and a thorough examination of their medical records.

But the change that has generated the most public attention is so-called gender-distinct pricing, a new strategy that will raise rates for single women by as much as 40 percent beginning in April. Genworth Financial, the nation’s largest long-term care insurance provider with more than a million policy holders, is the first to win approval by state insurance commissions to raise rates for single women purchasing new policies. Women, most of them single by the time they reach advanced age, cost the company $2 of every $3 in benefits paid so far, according to Steve Zabel, Genworth’s senior vice president for long-term care insurance.

The company also will introduce what Mr. Zabel called “enhanced underwriting,” or more stringent qualifying standards, including blood testing to check for nicotine, drugs and markers of cardiovascular disease for all new applicants, regardless of gender or marital status.

Now permitted in all states except Montana and Colorado, gender-distinct pricing will not affect Genworth’s current policyholders, only new applicants. But all other carriers are likely to follow, according to Jesse Slome, executive director of the American Association for Long-Term Insurance, a trade group in Westlake Village, Calif. With the entire industry headed toward higher rates, Mr. Slome recently warned women that “the window is closing” and that now is the time to grab a policy while the price is still manageable.

Women have always paid less than men for life insurance. But because they live longer, women are the disproportionate beneficiaries of long-term care insurance, which paid out $6.6 billion in benefits in 2011. Mr. Slome expects that number to top $7 billion in 2012.

The reasons are well known:

* On average, women outlive men by five years. Among those born in 1960, the average man will live to age 67 and the average woman to age 73. And women who reach age 65 can expect to live an average of 20 more years.

* By age 75, 7 in 10 women are widowed, divorced or have never been married. Some 40 percent of them live alone, compared to 22 percent of men. Two-thirds of those past the age of 85 are women, as are 80 percent of centenarians.

* Women who live to age 65 experience on average two years of disability requiring assistance before death. Those who reach age 80 will require three years of assistance.

* In nursing homes, the most expensive form of long-term care, 7 in 10 residents are women. They represent 76 percent of the residents in assisted living facilities and two-thirds of the recipients of home care. Virtually none of this is paid for by Medicare, the government’s health plan for those 65-and-over. In nursing homes, Medicaid, a poverty program, kicks in for residents who run out of money.

“Woman live longer than men,” said Suzanna de Baca, a vice president of wealth strategies at Ameriprise Financial. “This may mean we experience a longer period of decline. Unfortunately, we are often less likely to have a partner around to help take care of us than our male counterparts.’’

Long-term care, Mr. Slome said, “is truly a women’s issue.”

While acknowledging the extra expense of caring for women, Mr. Slome said that in his view insurance carriers are being disingenuous in blaming the new policies on long-apparent gender differences. Rather he said, the culprit in the changing requirements is interest rates. “Blame the Federal Reserve,’’ he said.

Insurance carriers invest premiums and need to earn enough on that investment to pay benefits. When interest rates were higher, it was not all that difficult. Now the numbers don’t pencil out, and stockholders are fuming. But it is illegal to file for premium increases with the state insurance commissions based on changes in the financial market, Mr. Slome said.

This position does not endear Mr. Slome to his membership, at least one of whom disputes the claim. Asked if the new rate policies were related to interest rates, Mr. Zabel of Genworth, in an e-mail, replied with a succinct “no.”

Insurers say they were not able to judge the costs of care until the payouts began in earnest.

So what is a woman trying to prepare for old age supposed to do, especially after the elimination of the Class Act, a modest attempt to include long-term care in the Affordable Care Act?

Ms. da Baca suggests “careful and thorough budgeting,” “focusing on wellness,” and “proactive steps” to research suitable places to live when home is no longer an option. Ms. da Baca also advises women to make home modifications — incrementally, as one’s budget permits — to increase the chances that you’ll be able to stay there longer.

Mr. Perry, of the Opus Advisory Group, suggests an intriguing option: life insurance with a chronic care rider, which permits the policy-holder to spend money for such needs while alive, although doing so will reduce the tax-free death benefit. Still, not all buyers — or their survivors — are willing to sacrifice those benefits.

“The need is still there, no question about it,’’ Mr. Perry said. But long-term care insurance is likely to become much harder for everyone to find and afford, especially women.


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Well: Warning Too Late for Some Babies

Six weeks after Jack Mahoney was born prematurely on Feb. 3, 2011, the neonatal staff at WakeMed Hospital in Raleigh, N.C., noticed that his heart rate slowed slightly when he ate. They figured he was having difficulty feeding, and they added a thickener to help.

When Jack was discharged, his parents were given the thickener, SimplyThick, to mix into his formula. Two weeks later, Jack was back in the hospital, with a swollen belly and in inconsolable pain. By then, most of his small intestine had stopped working. He died soon after, at 66 days old.

A month later, the Food and Drug Administration issued a caution that SimplyThick should not be fed to premature infants because it may cause necrotizing enterocolitis, or NEC, a life-threatening condition that damages intestinal tissue.


Catherine Saint Louis speaks about using SimplyThick in premature infants.



Experts do not know how the product may be linked to the condition, but Jack is not the only child to die after receiving SimplyThick. An F.D.A. investigation of 84 cases, published in The Journal of Pediatrics in 2012, found a “distinct illness pattern” in 22 instances that suggested a possible link between SimplyThick and NEC. Seven deaths were cited; 14 infants required surgery.

Last September, after more adverse events were reported, the F.D.A. warned that the thickener should not be given to any infants. But the fact that SimplyThick was widely used at all in neonatal intensive care units has spawned a spate of lawsuits and raised questions about regulatory oversight of food additives for infants.

SimplyThick is made from xanthan gum, a widely-used food additive on the F.D.A.’s list of substances “generally recognized as safe.” SimplyThick is classified as a food and the F.D.A. did not assess it for safety.

John Holahan, president of SimplyThick, which is based in St. Louis, acknowledged that the company marketed the product to speech language pathologists who in turn recommended it to infants. The patent touted its effectiveness in breast milk.

However, Mr. Holahan said, “There was no need to conduct studies, as the use of thickeners overall was already well established. In addition, the safety of xanthan gum was already well established.”

Since 2001, SimplyThick has been widely used by adults with swallowing difficulties. A liquid thickened to about the consistency of honey allows the drinker more time to close his airway and prevent aspiration.

Doctors in newborn intensive care units often ask non-physician colleagues like speech pathologists to determine whether an infant has a swallowing problem. And those auxiliary feeding specialists often recommended SimplyThick for neonates with swallowing troubles or acid reflux.

The thickener became popular because it was easy to mix, could be used with breast milk, and maintained its consistency, unlike alternatives like rice cereal.

“It was word of mouth, then neonatologists got used to using it. It became adopted,” said Dr. Steven Abrams, a neonatologist at Texas Children’s Hospital in Houston. “At any given time, several babies in our nursery — and in any neonatal unit — would be on it.”

But in early 2011, Dr. Benson Silverman, the director of the F.D.A.’s infant formula section, was alerted to an online forum where doctors had reported 15 cases of NEC among infants given SimplyThick. The agency issued its first warning about its use in babies that May. “We can only do something with the information we are provided with,” he said. “If information is not provided, how would we know?”

Most infants who took SimplyThick did not fall ill, and NEC is not uncommon in premature infants. But most who develop NEC do so while still in the hospital. Some premature infants given SimplyThick developed NEC later than usual, a few after they went home, a pattern the F.D.A. found unusually worrisome.

Even now it is not known how the thickener might have contributed to the infant deaths. One possibility is that xanthan gum itself is not suitable for the fragile digestive systems of newborns. The intestines of premature babies are “much more likely to have bacterial overgrowth” than adults’, said Dr. Jeffrey Pietz, the chief of newborn medicine at Children’s Hospital Central California in Madera.

“You try not to put anything in a baby’s intestine that’s not natural.” If you do, he added, “you’ve got to have a good reason.”

A second possibility is that batches of the thickener were contaminated with harmful bacteria. In late May 2011, the F.D.A. inspected the plants that make SimplyThick and found violations at one in Stone Mountain, Ga., including a failure to “thermally process” the product to destroy bacteria of a “public health significance.”

The company, Thermo Pac, voluntarily withdrew certain batches. But it appears some children may have ingested potentially contaminated batches.

The parents of Jaden Santos, a preemie who died of NEC while on SimplyThick, still have unused packets of recalled lots, according to their lawyer, Joe Taraska.

The authors of the F.D.A. report theorized that the infants’ intestinal membranes could have been damaged by bacteria breaking down the xanthan gum into too many toxic byproducts.

Dr. Qing Yang, a neonatologist at Wake Forest University, is a co-author of a case series in the Journal of Perinatology about three premature infants who took SimplyThick, developed NEC and were treated. The paper speculates that NEC was “most likely caused by the stimulation of the immature gut by xanthan gum.”

Dr. Yang said she only belatedly realized “there’s a lack of data” on xanthan gum’s use in preemies. “The lesson I learned is not to be totally dependent on the speech pathologist.”

Julie Mueller’s daughter Addison was born full-term and given SimplyThick after a swallow test showed she was at risk of choking. It was recommended by a speech pathologist at the hospital.

Less than a month later, Addison was dead with multiple holes in her small intestine. “It was a nightmare,” said Ms. Mueller, who has filed a lawsuit against SimplyThick. “I was astounded how a hospital and manufacturer was gearing this toward newborns when they never had to prove it would be safe for them. Basically we just did a research trial for the manufacturer.”

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Well: A Doctor's Struggle With Numbers

My youngest child has been struggling with numbers.

This all started around the time of his 4th birthday, in mid-November. He knew he was getting older and asked a lot of questions about babies, who were “too little to have a number,” being less than 1 year old. Then, on the day of his birthday, he wanted to know when he was turning 4.

I told him that today was his birthday, that he turned 4 today.

“But when do I turn 4?” He had recently learned to emphasize certain words in an effort to assist his dim parents in getting his questions answered.

I told him at 8 in the morning, the time he was born.

“No, no, when do I turn 4?”

I looked at him helplessly, wondering whether he was expecting some pivotal moment when he would suddenly gain five inches in height. He decided that the anointed time occurred later that day, after he received his presents.

A week later, his mother and I went for a car ride with her parents, both in their mid-70s. In a rare quiet moment amid the usual barrage of instructions on how to navigate the rural western Pennsylvania roads, our son spoke up.

“When is Pappy going to die?”

The adults fell over themselves responding, trying to both reassure him and ourselves, as if the faster and louder we answered his question, the more we would negate it: A lot of years. Not for a long, long time. We hope he never does.

This satisfied him for the moment, but much like his father, he broods about these types of important topics. A couple of hours later, back at the house, he asked as if in mid-thought: “But, what is the last number?”

I repeated his question, stalling.

“Yes, what is the last number? What’s my last number?” he asked. His mother and I glanced at each other, in a quick game of chicken to see who would answer first.

“We don’t know, honey,” I finally said. He looked up at my wife, who nodded in agreement.

My son’s words came back to me the following Monday when I saw my first patient, a man in his 70s whose leukemia didn’t get worse on chemotherapy, but unfortunately also didn’t get better. We had run out of options, aside from supportive care.

“How long does he have?”

My patient’s son asked the question that was on everyone’s mind, and when he did, the wave of emotion that washed across the room was almost palpable. My patient’s daughter crossed her legs, and his wife started to cry. So did my patient, though he tried to hide it, glancing up at the fluorescent ceiling lights of the clinic room. Guys in his generation, I’ve found, don’t like to appear weak in front of their family.

I turned to my patient and asked him if he wanted me to talk about this, about his prognosis. My first responsibility in this type of situation is always to my patient and what he wants to hear. Some people want to know specifics, down to the half-month of predicted survival; others want no information at all, as if hearing a number will seal their fate.

“Sure, I guess so,” he answered. He did want to know, but he didn’t want to know.

Oncologists are notoriously bad at predicting survival, and none of us wants to be known as “the doctor who told me I would be dead by now,” the doctor who made a prediction of imminent demise, sending a family into a terrifying tailspin of goodbyes, only to be proven wrong and subsequently mocked for years to come. One of my patients, upon being told by another doctor that she had two months to live, held Christmas in April so she could spend one last holiday with her grandchildren. She survived to see two more Christmases.

At the same time, we need to be truthful and give guidance to people who want time to prepare, time to write wills and pay off debts, to say goodbyes and to leave instructions, to tie up the loose ends of a life now heavy with meaning.

We try to provide hope, but not false hope.

So we give ranges, starting with the best estimate of survival, because my patients have told me they shut down after they hear the worst estimate. We talk about setting goals, about maximizing quality of life, because we don’t have much leverage with quantity of life. We emphasize spending as much time as possible with family and friends, and as little time as possible with people wearing white coats. We tell them we’re not going to give up if they don’t give up.

But the truth is, we don’t know.



Dr. Mikkael Sekeres is director of the leukemia program at the Cleveland Clinic.

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Concerns About A.D.H.D. Practices and Amphetamine Addiction


Before his addiction, Richard Fee was a popular college class president and aspiring medical student. "You keep giving Adderall to my son, you're going to kill him," said Rick Fee, Richard's father, to one of his son's doctors.







VIRGINIA BEACH — Every morning on her way to work, Kathy Fee holds her breath as she drives past the squat brick building that houses Dominion Psychiatric Associates.










Matt Eich for The New York Times

MENTAL HEALTH CLINIC Dominion Psychiatric Associates in Virginia Beach, where Richard Fee was treated by Dr. Waldo M. Ellison. After observing Richard and hearing his complaints about concentration, Dr. Ellison diagnosed attention deficit hyperactivity disorder and prescribed the stimulant Adderall.






It was there that her son, Richard, visited a doctor and received prescriptions for Adderall, an amphetamine-based medication for attention deficit hyperactivity disorder. It was in the parking lot that she insisted to Richard that he did not have A.D.H.D., not as a child and not now as a 24-year-old college graduate, and that he was getting dangerously addicted to the medication. It was inside the building that her husband, Rick, implored Richard’s doctor to stop prescribing him Adderall, warning, “You’re going to kill him.”


It was where, after becoming violently delusional and spending a week in a psychiatric hospital in 2011, Richard met with his doctor and received prescriptions for 90 more days of Adderall. He hanged himself in his bedroom closet two weeks after they expired.


The story of Richard Fee, an athletic, personable college class president and aspiring medical student, highlights widespread failings in the system through which five million Americans take medication for A.D.H.D., doctors and other experts said.


Medications like Adderall can markedly improve the lives of children and others with the disorder. But the tunnel-like focus the medicines provide has led growing numbers of teenagers and young adults to fake symptoms to obtain steady prescriptions for highly addictive medications that carry serious psychological dangers. These efforts are facilitated by a segment of doctors who skip established diagnostic procedures, renew prescriptions reflexively and spend too little time with patients to accurately monitor side effects.


Richard Fee’s experience included it all. Conversations with friends and family members and a review of detailed medical records depict an intelligent and articulate young man lying to doctor after doctor, physicians issuing hasty diagnoses, and psychiatrists continuing to prescribe medication — even increasing dosages — despite evidence of his growing addiction and psychiatric breakdown.


Very few people who misuse stimulants devolve into psychotic or suicidal addicts. But even one of Richard’s own physicians, Dr. Charles Parker, characterized his case as a virtual textbook for ways that A.D.H.D. practices can fail patients, particularly young adults. “We have a significant travesty being done in this country with how the diagnosis is being made and the meds are being administered,” said Dr. Parker, a psychiatrist in Virginia Beach. “I think it’s an abnegation of trust. The public needs to say this is totally unacceptable and walk out.”


Young adults are by far the fastest-growing segment of people taking A.D.H.D medications. Nearly 14 million monthly prescriptions for the condition were written for Americans ages 20 to 39 in 2011, two and a half times the 5.6 million just four years before, according to the data company I.M.S. Health. While this rise is generally attributed to the maturing of adolescents who have A.D.H.D. into young adults — combined with a greater recognition of adult A.D.H.D. in general — many experts caution that savvy college graduates, freed of parental oversight, can legally and easily obtain stimulant prescriptions from obliging doctors.


“Any step along the way, someone could have helped him — they were just handing out drugs,” said Richard’s father. Emphasizing that he had no intention of bringing legal action against any of the doctors involved, Mr. Fee said: “People have to know that kids are out there getting these drugs and getting addicted to them. And doctors are helping them do it.”


“...when he was in elementary school he fidgeted, daydreamed and got A’s. he has been an A-B student until mid college when he became scattered and he wandered while reading He never had to study. Presently without medication, his mind thinks most of the time, he procrastinated, he multitasks not finishing in a timely manner.”


Dr. Waldo M. Ellison


Richard Fee initial evaluation


Feb. 5, 2010


Richard began acting strangely soon after moving back home in late 2009, his parents said. He stayed up for days at a time, went from gregarious to grumpy and back, and scrawled compulsively in notebooks. His father, while trying to add Richard to his health insurance policy, learned that he was taking Vyvanse for A.D.H.D.


Richard explained to him that he had been having trouble concentrating while studying for medical school entrance exams the previous year and that he had seen a doctor and received a diagnosis. His father reacted with surprise. Richard had never shown any A.D.H.D. symptoms his entire life, from nursery school through high school, when he was awarded a full academic scholarship to Greensboro College in North Carolina. Mr. Fee also expressed concerns about the safety of his son’s taking daily amphetamines for a condition he might not have.


“The doctor wouldn’t give me anything that’s bad for me,” Mr. Fee recalled his son saying that day. “I’m not buying it on the street corner.”


This article has been revised to reflect the following correction:

Correction: February 3, 2013

An earlier version of a quote appearing with the home page presentation of this article misspelled the name of a medication. It is Adderall, not Aderall.



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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 Lafayette, 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.”


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Well: Gluten-Free Muffin Recipes

For people who need to eliminate gluten from their diet, baking becomes a challenge. Beginners often find gluten-free baked goods too dense. Even the Recipes for Health columnist Martha Rose Shulman didn’t like the flavor of a commercial gluten-free flour mix, which left her gluten-free cookies and tart-shells with a strong taste of bean flour. As a result, she created her own gluten-free mix for baking muffins. She writes:

My son Liam still doesn’t know that the muffins he has been devouring all week are gluten-free.

I put together my own gluten-free flour mix, one without bean flour, and turned to America’s favorite Gluten-Free Girl, Shauna James Ahem, for guidance. I was already thinking about making muffins, and I wanted a mix that could replace the whole wheat flour I usually use in conjunction with other grains or flours. Her formula for a whole-grain flour mix is simple – 70 percent ground gluten-free grain like rice flour, millet flour, buckwheat flour or teff (the list on her site is a long one) and 30 percent starch like potato starch, cornstarch or arrowroot.

For this week’s recipes, I used what I had, which was brown rice flour, potato starch and cornstarch – 20 percent potato starch and 10 percent cornstarch — and that’s the basis for the nutritional analyses of this week’s recipes. I used this mix in conjunction with a gluten-free meal or flour, so the amount of pure starch in the batters is much less than 30 percent.

When you bake anything it is much simpler and results are more consistent if you use grams and scale your ingredients. This is especially true with gluten-free baking, since you are working with grain and starch formulas. Digital scales are not expensive and I urge you to switch over to this method if you like to bake. I have given approximate cup measures so the recipes will work both ways, but scaling is more accurate.

Here are five ways to bake gluten-free muffins:

Gluten-Free Banana Chocolate Muffins: These dark chocolate muffins taste more extravagant than they are.


Gluten-Free Cornmeal, Fig and Orange Muffins: A sweet and grainy cornmeal mixture makes for a delicious muffin.


Gluten-Free Whole Grain Cheese and Mustard Muffins: A savory muffin with a delicious strong flavor.


Gluten-Free Buckwheat, Poppy Seed and Blueberry Muffins: The buckwheat flour is high-fiber and makes a dark, richly-flavored muffin.


Gluten-Free Cornmeal Molasses Muffins: Strong molasses provides a good source of iron in an easy-to-make muffin.


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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

The headline on an earlier version of this article described the start of the DePuy trial incorrectly. It began last week, not Wednesday. The error was repeated in an earlier summary.



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The Consumer: The Drug-Dose Gender Gap

Most sleeping pills are designed to knock you out for eight hours. When the Food and Drug Administration was evaluating a new short-acting pill for people to take when they wake up in the middle of the night, agency scientists wanted to know how much of the drug would still be in users’ systems come morning.

Blood tests uncovered a gender gap: Men metabolized the drug, Intermezzo, faster than women. Ultimately the F.D.A. approved a 3.5 milligram pill for men, and a 1.75 milligram pill for women.

The active ingredient in Intermezzo, zolpidem, is used in many other sleeping aids, including Ambien. But it wasn’t until earlier this month that the F.D.A. reduced doses of Ambien for women by half.

Sleeping pills are hardly the only medications that may have unexpected, even dangerous, effects in women. Studies have shown that women respond differently than men to many drugs, from aspirin to anesthesia. Researchers are only beginning to understand the scope of the issue, but many believe that as a result, women experience a disproportionate share of adverse, often more severe, side effects.

“This is not just about Ambien — that’s just the tip of the iceberg,” said Dr. Janine Clayton, director for the Office of Research on Women’s Health at the National Institutes of Health. “There are a lot of sex differences for a lot of drugs, some of which are well known and some that are not well recognized.”

Until 1993, women of childbearing age were routinely excluded from trials of new drugs. When the F.D.A. lifted the ban that year, agency researchers noted that because landmark studies on aspirin in heart disease and stroke had not included women, the scientific community was left “with doubts about whether aspirin was, in fact, effective in women for these indications.”

Because so many drugs were tested mostly or exclusively in men, scientists may know little of their effects on women until they reach the market. A Government Accountability Office study found that 8 of 10 drugs removed from the market from 1997 through 2000 posed greater health risks to women.

For example, Seldane, an antihistamine, and the gastrointestinal drug Propulsid both triggered a potentially fatal heart arrhythmia more often in women than in men. Many drugs still on the market cause this arrhythmia more often in women, including antibiotics, antipsychotics, anti-malarial drugs and cholesterol-lowering drugs, Dr. Clayton said. Women also tend to use more medications than men.

The sex differences cut both ways. Some drugs, like the high blood pressure drug Verapamil and the antibiotic erythromycin, appear to be more effective in women. On the other hand, women tend to wake up from anesthesia faster than men and are more likely to experience side effects from anesthetic drugs, according to the Society for Women’s Health Research.

Women also react differently to alcohol, tobacco and cocaine, studies have found.

It’s not just because women tend to be smaller than men. Women metabolize drugs differently because they have a higher percentage of body fat and experience hormonal fluctuations and the monthly menstrual cycle. “Some drugs are more water-based and like to hang out in the blood, and some like to hang out in the fat tissue,” said Wesley Lindsey, assistant professor of pharmacy practice at Auburn University, who is a co-author of a paper on sex-based differences in drug activity.

“If the drug is lipophilic” — attracted to fat cells — “it will move into those tissues and hang around for longer,” Dr. Lindsey added. “The body won’t clear it as quickly, and you’ll see effects longer.”

There are also sex differences in liver metabolism, kidney function and certain gastric enzymes. Oral contraceptives, menopause and post-menopausal hormone treatment further complicate the picture. Some studies suggest, for example, that when estrogen levels are low, women may need higher doses of drugs called angiotensin receptor blockers to lower blood pressure, because they have higher levels of proteins that cause the blood vessels to constrict, said Kathryn Sandberg, director of the Center for the Study of Sex Differences in Health, Aging and Disease at Georgetown.

Many researchers say data on these sex differences must be gathered at the very beginning of a drug’s development — even before trials on human subjects begin.

“The path to a new drug starts with the basic science — you study an animal model of the disease, and that’s where you discover a drug target,” Dr. Sandberg said. “But 90 percent of researchers are still studying male animal models of the disease.”

There have been improvements. In an interview, Dr. Robert Temple, with the Center for Drug Evaluation and Research at the F.D.A., said the agency’s new guidelines in 1993 called for studies of sex differences at the earliest stages of drug development, as well as for analysis of clinical trial data by sex.

He said early research on an irritable bowel syndrome drug, alosetron (Lotronex), suggested it would not be effective in men. As a result, only women were included in clinical trials, and it was approved only for women. (Its use is restricted now because of serious side effects.)

But some scientists say drug metabolism studies with only 10 or 15 subjects are too small to pick up sex differences. Even though more women participate in clinical trials than in the past, they are still underrepresented in trials for heart and kidney disease, according to one recent analysis, and even in cancer trials.

“The big problem is we’re not quite sure how much difference this makes,” Dr. Lindsey said. “We just don’t have a good handle on it.”


Readers may submit comments or questions for The Consumer by e-mail to consumer@nytimes.com.

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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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Well: 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:


Jane Brody speaks about hypertension.




¶ 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.


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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Brain Aging Linked to Sleep-Related Memory Decline


For decades scientists have known that the ability to remember newly learned information declines with age, but it was not clear why. A new study may provide part of the answer.


The report, posted online on Sunday by the journal Nature Neuroscience, suggests that structural brain changes occurring naturally over time interfere with sleep quality, which in turn blunts the ability to store memories for the long term.


Previous research had found that the prefrontal cortex, the brain region behind the forehead, tends to lose volume with age, and that part of this region helps sustain quality sleep, which is critical to consolidating new memories. But the new experiment, led by scientists at the University of California, Berkeley, is the first to link structural changes directly with sleep-related memory problems.


The findings suggest that one way to slow memory decline in aging adults is to improve sleep, specifically the so-called slow-wave phase, which constitutes about a quarter of a normal night’s slumber.


Doctors cannot reverse structural changes that occur with age any more than they can turn back time. But at least two groups are experimenting with electrical stimulation as a way to improve deep sleep in older people. By placing electrodes on the scalp, scientists can run a low current across the prefrontal area, essentially mimicking the shape of clean, high-quality slow waves.


The result: improved memory, at least in some studies. “There are also a number of other ways you can improve sleep, including exercise,” said Ken Paller, a professor of psychology and director of the cognitive neuroscience program at Northwestern, who was not involved in the research.


Dr. Paller said that a whole array of changes occurred across the brain during aging and that sleep was only one factor affecting memory function.


But Dr. Paller said that the study told “a convincing story, I think: that atrophy is related to slow-wave sleep, which we know is related to memory performance. So it’s a contributing factor.”


In the study, a research team in California took brain images from 19 people of retirement age and 18 in their early 20s. It found that a brain area called the medial prefrontal cortex, roughly behind the middle of the forehead, was about a third smaller on average in the older group than in the younger one — a difference due to natural atrophy over time, previous research suggests.


Before bedtime, the team had the two groups study a long list of words paired with nonsense syllables, like “action-siblis” and “arm-reconver.” The team used such nonwords because one type of memory that declines with age is for new, previously unseen information.


After training on the pairs for half an hour or so, the participants took a test on some of them. The young group outscored the older group by about 25 percent.


Then everyone went to bed — and bigger differences emerged. For one, the older group got only about a quarter of the amount of high-quality slow-wave sleep that the younger group did, as measured by the shape and consistency of electrical waves on an electroencephalogram machine, or EEG. It is thought that the brain moves memories from temporary to longer-term storage during this deep sleep.


On a second test, given in the morning, the younger group outscored the older group by about 55 percent. The estimated amount of atrophy in each person roughly predicted the difference between his or her morning and evening scores, the study found. Even seniors who were very sharp at night showed declines after sleeping.


“The analysis showed that the differences were due not to changes in capacity for memories, but to differences in sleep quality,” said Bryce A. Mander, a postdoctoral fellow at Berkeley, and the lead author of the study. His co-authors included researchers from the California Pacific Medical Center in San Francisco; the University of California, San Diego; and the Lawrence Berkeley National Laboratory.


The findings do not imply that medial prefrontal atrophy is the only age-related change causing memory problems, said Matthew P. Walker, a professor of psychology and neuroscience at Berkeley, and a co-author of the study.


“But these things are interrelated,” Dr. Walker said. “Essentially, with time, the less and less tissue you have in this prefrontal area, the less and less quality deep wave sleep you get, the less and less you remember of content that you just learned.”


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Religious Groups and Employers Battle Contraception Mandate


Shawn Thew/European Pressphoto Agency


President Obama, with his health secretary, Kathleen Sebelius, offering a compromise on the contraception mandate last year.







In a flood of lawsuits, Roman Catholics, evangelicals and Mennonites are challenging a provision in the new health care law that requires employers to cover birth control in employee health plans — a high-stakes clash between religious freedom and health care access that appears headed to the Supreme Court.




In recent months, federal courts have seen dozens of lawsuits brought not only by religious institutions like Catholic dioceses but also by private employers ranging from a pizza mogul to produce transporters who say the government is forcing them to violate core tenets of their faith. Some have been turned away by judges convinced that access to contraception is a vital health need and a compelling state interest. Others have been told that their beliefs appear to outweigh any state interest and that they may hold off complying with the law until their cases have been judged. New suits are filed nearly weekly.


“This is highly likely to end up at the Supreme Court,” said Douglas Laycock, a law professor at the University of Virginia and one of the country’s top scholars on church-state conflicts. “There are so many cases, and we are already getting strong disagreements among the circuit courts.”


President Obama’s health care law, known as the Affordable Care Act, was the most fought-over piece of legislation in his first term and was the focus of a highly contentious Supreme Court decision last year that found it to be constitutional.


But a provision requiring the full coverage of contraception remains a matter of fierce controversy. The law says that companies must fully cover all “contraceptive methods and sterilization procedures” approved by the Food and Drug Administration, including “morning-after pills” and intrauterine devices whose effects some contend are akin to abortion.


As applied by the Health and Human Services Department, the law offers an exemption for “religious employers,” meaning those who meet a four-part test: that their purpose is to inculcate religious values, that they primarily employ and serve people who share their religious tenets, and that they are nonprofit groups under federal tax law.


But many institutions, including religious schools and colleges, do not meet those criteria because they employ and teach members of other religions and have a broader purpose than inculcating religious values.


“We represent a Catholic college founded by Benedictine monks,” said Kyle Duncan, general counsel of the Becket Fund for Religious Liberty, which has brought a number of the cases to court. “They don’t qualify as a house of worship and don’t turn away people in hiring or as students because they are not Catholic.”


In that case, involving Belmont Abbey College in North Carolina, a federal appeals court panel in Washington told the college last month that it could hold off on complying with the law while the federal government works on a promised exemption for religiously-affiliated institutions. The court told the government that it wanted an update by mid-February.


Defenders of the provision say employers may not be permitted to impose their views on employees, especially when something so central as health care is concerned.


“Ninety-nine percent of women use contraceptives at some time in their lives,” said Judy Waxman, a vice president of the National Women’s Law Center, which filed a brief supporting the government in one of the cases. “There is a strong and legitimate government interest because it affects the health of women and babies.”


She added, referring to the Centers for Disease Control and Prevention, “Contraception was declared by the C.D.C. to be one of the 10 greatest public health achievements of the 20th century.”


Officials at the Justice Department and the Health and Human Services Department declined to comment, saying the cases were pending.


A compromise for religious institutions may be worked out. The government hopes that by placing the burden on insurance companies rather than on the organizations, the objections will be overcome. Even more challenging cases involve private companies run by people who reject all or many forms of contraception.


The Alliance Defending Freedom — like Becket, a conservative group — has brought a case on behalf of Hercules Industries, a company in Denver that makes sheet metal products. It was granted an injunction by a judge in Colorado who said the religious values of the family owners were infringed by the law.


“Two-thirds of the cases have had injunctions against Obamacare, and most are headed to courts of appeals,” said Matt Bowman, senior legal counsel for the alliance. “It is clear that a substantial number of these cases will vindicate religious freedom over Obamacare. But it seems likely that the Supreme Court will ultimately resolve the dispute.”


The timing of these cases remains in flux. Half a dozen will probably be argued by this summer, perhaps in time for inclusion on the Supreme Court’s docket next term. So far, two- and three-judge panels on four federal appeals courts have weighed in, granting some injunctions while denying others.


One of the biggest cases involves Hobby Lobby, which started as a picture framing shop in an Oklahoma City garage with $600 and is now one of the country’s largest arts and crafts retailers, with more than 500 stores in 41 states.


David Green, the company’s founder, is an evangelical Christian who says he runs his company on biblical principles, including closing on Sunday so employees can be with their families, paying nearly double the minimum wage and providing employees with comprehensive health insurance.


Mr. Green does not object to covering contraception but considers morning-after pills to be abortion-inducing and therefore wrong.


“Our family is now being forced to choose between following the laws of the land that we love or maintaining the religious beliefs that have made our business successful and have supported our family and thousands of our employees and their families,” Mr. Green said in a statement. “We simply cannot abandon our religious beliefs to comply with this mandate.”


The United States Court of Appeals for the 10th Circuit last month turned down his family’s request for a preliminary injunction, but the company has found a legal way to delay compliance for some months.


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