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I.R.S. to Base Insurance Affordability on Single Coverage

Written By Unknown on Kamis, 31 Januari 2013 | 13.57

WASHINGTON — The Obama administration adopted a strict definition of affordable health insurance on Wednesday that will deny federal financial assistance to millions of Americans with modest incomes who cannot afford family coverage offered by employers.

In deciding whether an employer's health plan is affordable, the Internal Revenue Service said it would look at the cost of coverage only for an individual employee, not for a family. Family coverage might be prohibitively expensive, but federal subsidies would not be available to help buy insurance for children in the family.

The policy decision came in a final regulation interpreting ambiguous language in the 2010 health care law.

Under the law, most Americans will be required to have health insurance starting next year. Low- and middle-income people can get tax credits to help them pay premiums, unless they have access to affordable coverage from an employer.

The law specifies that employer-sponsored insurance is not affordable if a worker's share of the premium is more than 9.5 percent of the worker's household income. The I.R.S. said this calculation should be based solely on the cost of individual coverage, what the worker would pay for "self-only coverage."

"This is bad news for kids," said Jocelyn A. Guyer, an executive director of the Center for Children and Families at Georgetown University. "We can see kids falling through the cracks. They will lack access to affordable employer-based family coverage and still be locked out of tax credits to help them buy coverage for their kids in the marketplaces, or exchanges, being established in every state."

In 2012, according to an annual survey by the Kaiser Family Foundation, total premiums for employer-sponsored health insurance averaged $5,615 a year for single coverage and $15,745 for family coverage. The employee's share of the premium averaged $951 for individual coverage and more than four times as much, $4,316, for family coverage.

Under the I.R.S. rule, such costs would be considered affordable for a family making $35,000 a year, even though the family would have to spend 12 percent of its income for full coverage under the employer's plan.

The tax agency proposed this approach in August 2011 and made no change in the definition of "affordable coverage" despite protests from advocates for children and low-income people and many employers. Employers did not want to be required to pay for coverage of employees' dependents. But they said that family members should have access to subsidies so they could buy insurance on their own.

However, that would have increased costs to the government, which would have been required to spend more on subsidies.

Paul W. Dennett, senior vice president of the American Benefits Council, which represents many Fortune 500 companies, said: "Individuals who do not have affordable family coverage should be eligible for premium tax credits in the exchange. The final rule does not provide that."

Under the law, people who go without insurance will generally be subject to tax penalties. In a separate proposed regulation issued on Wednesday, the Internal Revenue Service said that the uninsured children and spouse of an employee would be exempt from the penalties if the cost of coverage for the entire family under an employer's plan was more than 8 percent of household income.

Bruce Lesley, the president of First Focus, a child advocacy group, said: "The administration recognizes that the cost of family coverage will be unaffordable for many families. They will not have to pay the penalty. But that will not be much of a consolation to families who cannot get health insurance for their kids."

The 2010 health care law extended Medicaid to many childless adults and others who were previously ineligible. The Supreme Court said the expansion of Medicaid was an option for states, not a requirement as Congress had intended.

Kathleen Sebelius, the secretary of health and human services, said Wednesday that she wanted to use her discretion to prevent the imposition of tax penalties on certain uninsured low-income people in states that choose not to expand Medicaid.

A rule proposed by her department would guarantee an exemption from the penalties for anyone found ineligible for Medicaid solely because of a state's decision not to expand the program. The administration said this was "an appropriate use of the hardship exemption."

About 20 states are expected to expand Medicaid; governors in other states are opposed or uncommitted. Many illegal immigrants, prisoners and members of certain religious groups opposed to the acceptance of insurance benefits will also be exempt from penalties if they forgo coverage, the administration said.

The Congressional Budget Office predicts that 30 million people will be uninsured in 2016 and that 6 million of them will pay penalties.


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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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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. They protect your head from severe injury. During the Big Air finals at the Winter X Games in Aspen, Colo., this past weekend, for instance, 23-year-old Icelandic snowboarder Halldor Helgason over-rotated on a triple back flip, landed head-first 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 attempted 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 helmeted or bare.

Interestingly, the skiers and riders who were the most likely, in general, to don 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 of 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," says 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 takeaway 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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Well: Waiting for Alzheimer's to Begin

My gray matter might be waning. Then again, it might not be. But I swear that I can feel memories — as I'm making them — slide off a neuron and into a tangle of plaque. I steel myself for those moments to come when I won't remember what just went into my head.

I'm not losing track of my car keys, which is pretty standard in aging minds. Nor have I ever forgotten to turn off the oven after use, common in menopausal women. I can always find my car in the parking lot, although lots of "normal" folk can't.

Rather, I suddenly can't remember the name of someone with whom I've worked for years. I cover by saying "sir" or "madam" like the Southerner I am, even though I live in Vermont and grown people here don't use such terms. Better to think I'm quirky than losing my faculties. Sometimes I'll send myself an e-mail to-do reminder and then, seconds later, find myself thrilled to see a new entry pop into my inbox. Oops, it's from me. Worse yet, a massage therapist kicked me out of her practice for missing three appointments. I didn't recall making any of them. There must another Nancy.

Am I losing track of me?

Equally worrisome are the memories increasingly coming to the fore. Magically, these random recollections manage to circumnavigate my imagined build-up of beta-amyloid en route to delivering vivid images of my father's first steps down his path of forgetting. He was the same age I am now, which is 46.

"How old are you?" I recall him asking me back then. Some years later, he began calling me every Dec. 28 to say, "Happy birthday," instead of on the correct date, Dec. 27. The 28th had been his grandmother's birthday.

The chasms were small at first. Explainable. Dismissible. When he crossed the street without looking both ways, we chalked it up to his well-cultivated, absent-minded professor persona. But the chasms grew into sinkholes, and eventually quicksand. When we took him to get new pants one day, he kept trying on the same ones he wore to the store.

"I like these slacks," he'd say, over and over again, as he repeatedly pulled his pair up and down.

My dad died of Alzheimer's last April at age 73 — the same age at which his father succumbed to the same disease. My dad ended up choosing neurology as his profession after witnessing the very beginning of his own dad's forgetting.

Decades later, grandfather's atrophied brain found its way into a jar on my father's office desk. Was it meant to be an ever-present reminder of Alzheimer's effect? Or was it a crystal ball sent to warn of genetic fate? My father the doctor never said, nor did he ever mention, that it was his father's gray matter floating in that pool of formaldehyde.

Using the jarred brain as a teaching tool, my dad showed my 8-year-old self the difference between frontal and temporal lobes. He also pointed out how brains with Alzheimer's disease become smaller, and how wide grooves develop in the cerebral cortex. But only after his death — and my mother's confession about whose brain occupied that jar — did I figure out that my father was quite literally demonstrating how this disease runs through our heads.

Has my forgetting begun?

I called my dad's neurologist. To find out if I was in the earliest stages of Alzheimer's, he would have to look for proteins in my blood or spinal fluid and employ expensive neuroimaging tests. If he found any indication of onset, the only option would be experimental trials.

But documented confirmation of a diseased brain would break my still hopeful heart. I'd walk around with the scarlet letter "A" etched on the inside of my forehead — obstructing how I view every situation instead of the intermittent clouding I currently experience.

"You're still grieving your father," the doctor said at the end of our call. "Sadness and depression affect the memory, too. Let's wait and see."

It certainly didn't help matters that two people at my father's funeral made some insensitive remarks.

"Nancy, you must be scared to death."

"Is it hard knowing the same thing probably will happen to you?"

Maybe the real question is what to do when the forgetting begins. My dad started taking 70 supplements a day in hopes of saving his mind. He begged me to kill him if he wound up like his father. He retired from his practice and spent all day in a chair doing puzzles. He stopped making new memories in an all-out effort to preserve the ones he already had.

Maybe his approach wasn't the answer.

Just before his death — his brain a fraction of its former self — my father managed to offer up a final lesson. I was visiting him in the memory-care center when he got a strange look on his face. I figured it was gas. But then his eyes lit up and a big grin overtook him, and he looked right at me and said, "Funny how things turn out."

An unforgettable moment?

I can only hope.



Nancy Stearns Bercaw is a writer in Vermont. Her book, "Brain in a Jar: A Daughter's Journey Through Her Father's Memory," will be published in April 2013 by Broadstone.


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F.D.A. Approves Genetic Drug to Treat Rare Disease

Written By Unknown on Rabu, 30 Januari 2013 | 13.57

The Food and Drug Administration approved a new drug Tuesday that not only treats a rare inherited disorder that causes extremely high cholesterol levels and heart attacks by age 30, but does so using a long-sought technology that can shut off specific genes that cause disease.

The drug, Kynamro, which was invented by Isis Pharmaceuticals and will be marketed by Sanofi's Genzyme division, is unlikely to be a blockbuster. It has some worrisome side effects and there might be no more than a few hundred people in the United States with the disease, known as homozygous familial hypercholesterolemia, or HoFH.

Still, Kynamro could become the first commercial success for the gene silencing technique, which is known as antisense, and which some experts say is finally poised to fulfill its promise after over two decades of research and numerous disappointments.

"What many people have been waiting for is validation where someone actually makes a profit and where patients actually benefit," said Arthur M. Krieg, chief executive of RaNA Therapeutics, an antisense drug developer in Cambridge, Mass.

Isis, which is based in Carlsbad, Calif., has been pursuing antisense technology since the company's founding in 1989, spending about $2 billion. It had one drug approved in 1998 for an infection associated with AIDS, but the drug did not sell well and some experts said it did not really use the gene-silencing mechanism.

Isis's experience contrasts with that of Gilead Sciences, which was also founded in the late 1980s to pursue antisense technology. It gave up after several years — selling the patents it no longer needed to Isis — and went on to develop antiviral drugs using other techniques. It is now a biotech superstar with a market value of $59.8 billion, compared with $1.4 billion for Isis.

Stanley T. Crooke, the founder and chief executive of Isis since its inception, said the long period of development was not unusual for a new technology.

"I told people it would be at least 20 years and $2 billion before we knew if the technology would work," he said in an interview Tuesday. "We think it's a seminal day for the technology and the company."

Isis or its partners are developing drugs to lower triglycerides, treat spinal muscular atrophy and reduce scarring from operations, among other things. The partners include Biogen Idec, Pfizer and AstraZeneca.

Two rival antisense companies, Sarepta Therapeutics and Prosensa are developing drugs for muscular dystrophy that have shown promise in early clinical trials.

Still, Dr. Cy Stein, a longtime antisense researcher, said it was too early to say that antisense had arrived. There have been false dawns in the field before.

Antisense drugs work essentially by shooting the messenger. The recipe to make a protein is carried from a gene in the nucleus into the body of a cell by a single strand of RNA, called messenger RNA.

Antisense drugs are small snippets of synthetic DNA or RNA that bind to that messenger RNA in a way that inactivates or destroys it.

In theory, an antisense drug can be made to shut down any gene, providing a means to develop a virtually unlimited number of drugs. But in practice, it has been difficult to deliver the drugs into cells with sufficient potency and lack of toxicity. Companies have developed ways to chemically modify the drugs to help in that regard.

Kynamro, known generically as mipomersen, inhibits action of a gene, apolipoprotein B, that is involved in the formation of particles that carry cholesterol in the blood.

If untreated, people with HoFH can have levels of LDL cholesterol, the so-called bad cholesterol, as high as 1,000 milligrams per deciliter. A level of 130 or less for LDL is generally considered desirable.

Statins work for these patients and have helped increase the typical life span to 33 years, from 18, but further cholesterol reduction is needed. Patients can also have their blood cleansed of cholesterol by being connected to a machine for a few hours once a week.

Patients in the main clinical trial of Kynamro started with LDL levels of around 400. After 26 weeks of treatment, those getting Kynamro had a mean decline in LDL cholesterol of 24.7 percent compared with a decline of 3.3 percent for those getting a placebo.

The label for Kynamro will carry a boxed warning about potential liver damage. Other side effects include injection-site reactions and flulike symptoms.

Kynamro will share the market with Juxtapid, a drug developed by Aegerion Pharmaceuticals that won approval last month.

In October, an F.D.A. advisory committee voted 13-to-2 in favor of approval of Juxtapid but only 9-to-6 in favor of Kynamro, largely because of concern about side effects. Juxtapid is a once-a-day pill, while Kynamro is injected once a week.

Genzyme has not announced the price for Kynamro but it might be similar to that of Juxtapid, which costs $235,000 to $295,000 a year, similar to some other drugs for extremely rare conditions.


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IGF-1 Has Long Been Banned as a Performance Enhancer

In theory, at least, IGF-1 seems almost too good to be true.

It can, at least in animals, heal tendon injuries and build muscles. Available at anti-aging clinics, IGF-1, or insulinlike growth factor-1, has also found favor among athletes for the same reasons that its better-known relative human growth hormone has: it is believed to make an athlete bigger, faster and stronger. It may boost muscle, reduce fat and improve endurance.

IGF-1 came to foreground Tuesday when it was mentioned among the performance-enhancing drugs that a South Florida clinic provided to six baseball players and other professional athletes, according to a report in the Miami New Times newspaper. Sports Illustrated also reported Tuesday that some football players used a substance taken from deer-antler velvet that contains IGF-1.

Although IGF-1 is unknown to most sports fans, for years the drug has been a mainstay in the constellation of banned performance-enhancing drugs. It has long been on the World Anti-Doping Agency banned substances list, alongside human growth hormone.

There is no widely available urine test for IGF-1, but like human growth hormone, IGF-1 can be detected in blood tests. However, until this month, Major League Baseball and its players union had not reached an agreement to conduct in-season blood testing for human grown hormone.

IGF-1 is made in response to growth hormone and is needed for growth hormone to have its effects on muscles and other tissues. Growth hormone, synthesized in the pituitary gland, travels to the liver, which then responds by producing IGF-1.

The Food and Drug Administration has approved IGF-1 for children with a rare condition in which they fail to make enough of it. Their bones do not grow sufficiently and the children are very short. The drug, sold by Ipsen, is injected under the skin and travels through the blood to bones, stimulating them to grow.

IGF-1 and deer-antler sprays have drawn attention among elite athletes in recent years. St. Louis Rams linebacker David Vobora won a $5.4 million judgment against Sports With Alternatives to Steroids, or S.W.A.T.S., over the use of one of its sprays, which reportedly contained banned substances including IGF-1. The IGF-1 that the company sells is "natural, not synthetic," said Mitch Ross, the founder of S.W.A.T.S., adding that it is "a raw food, not a drug."

IGF-1 is "just like giving someone human growth hormone," said Don Catlin, the former head of U.C.L.A.'s Olympic Analytical Lab, best known for breaking the Bay Area Laboratory Co-operative doping ring. "It goes to the same kinds of receptors and turns them on."

The S.W.A.T.S. Web site promotes the company as being for "athletes competing without cheating" and its Facebook page lists "IGF-1 Supplement (Deer Antler Velvet)" among its products. Online message boards brim with commentary about its effectiveness, but doctors have called into question whether IGF-1 works in spray form.

Ross, of S.W.A.T. S, said that while he had not tested the long-term effects of natural IGF-1, he maintained that the drug was safe. "If you abuse it, you could have side effects," he said.

While IGF-1 could help athletes in theory, said Dr. Alan Rogol, a vice president of the Endocrine Society, there are no scientific studies with humans to show the expected effects actually occur. In animals, he said, if IGF-1 is injected into the body, muscles grow. If an animal is produced with genes that cause one muscle to overproduce IGF-1, that muscle grows, and if a tendon is injured, IGF-1 speeds healing.

One of the two tests used to detect growth hormone should also detect abuse of IGF-1. It's called the marker test and what it actually measures is not growth hormone but growth hormone's effects — an increase in IGF-1 and an increase in one of the metabolites released when a tendon is being repaired. The other growth hormone test, the isoform test, looks directly for the hormone and so it would not pick up IGF-1.

Rogol, among a small group of doctors who evaluate therapeutic exemptions for the antidoping agency, said the marker test has picked up a few athletes who tested positive, and most admitted growth hormone abuse.

Both growth hormone and IGF-1 are expensive, he added. Each may cost more than $25,000 a year for a child who is using one of the drugs for legitimate reasons. Athletes may use five or 10 times as much IGF-1 or growth hormone because they are bigger and use higher doses.

For professional athletes making millions of dollars a year, "that cost may be trivial," Rogol said.

Still, the age-old temptations to pursue the use of performance-enhancing drugs remain and make IGF-1 still relevant, doping experts said.

"The only sport where you may not want to use it is curling," Charles Yesalis, a professor emeritus of health policy and administration at Penn State, said of IGF-1. "In what sport does not being bigger and faster help you do better?"

Given the lags in implementing blood testing for the drug and number of anti-aging clinics sprinkled throughout the country, Yesalis said he was far from surprised when he heard about the wave of headlines Tuesday about IGF-1.

"I think this goes on all the time," he said. "My response to this one is kind of a yawn. Drug tests didn't bust these guys. It's just business as usual."


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Super Bowl: At Media Day, Spotlight on Head Injuries Grows

Chang W. Lee/The New York Times

Coach Jim Harbaugh arranged his 49ers for a Super Bowl photo at the Super Dome.

NEW ORLEANS — It has become a staple of Super Bowl week, as much a part of the pregame to the N.F.L.'s biggest event as the annual media day: a discussion of how football is being affected by head injuries and the mounting evidence that long-term brain damage can be linked to injuries sustained on the field.

Years ago, players rarely spoke about the issue and league officials dismissed suggestions that on-field injuries could lead to life-altering health problems. Now, however, the league is facing lawsuits from thousands of former players, rules are being instituted in an attempt to diminish injuries on the field and even President Obama has said that the way football is played will have to change. This week, Bernard Pollard, a hard-hitting safety for the Baltimore Ravens, created a stir by saying that the N.F.L. would not exist in 30 years because of the rules changes designed with safety in mind, but that he also believed there would be a death on the field at some point.

At media day Tuesday, players reacted to the comments made by Pollard and Obama, with some agreeing with Pollard that recent rules changes would change the sport to such an extent that it would be less entertaining and lead to a loss of popularity. Pollard stood by his comments. He added, however, that while he was comfortable with the physical risk he was taking by playing football, he was not sure he would want future generations, including his 4-year-old son, to follow his example.

"My whole stance right now is that I don't want him to play football," Pollard said. "Football has been good to me. It has been my outlet. God has blessed me with a tremendous talent to be able to play this game. But we want our kids to have things better than us."

He said he did not want his son to go through the aches and pains caused by the physicality of the game.

"You keep playing football, you're going to have your injuries, no one is exempt from that," he said. "You're going to have concussions. You're going to have broken bones. That's going to happen. But I think for the most part, we know what we signed up for."

The sentiment was echoed by Baltimore quarterback Joe Flacco. "I play the game and I understand that I'm going to get hit," Flacco said. "Just because they fine the guys is not going to stop them from hitting me. I find it tough to fine people who are doing their job."

In a recent interview with The New Republic, Obama expressed concern about on-field injuries, though he added that N.F.L. players were grown men who are "well-compensated for the violence they do to their bodies."

The president added: "I think that those of us who love the sport are going to have to wrestle with the fact that it will probably change gradually to try to reduce some of the violence. In some cases, that may make it a little bit less exciting, but it will be a whole lot better for the players, and those of us who are fans maybe won't have to examine our consciences quite as much."

While many current players seem focused on rules changes and how they will affect the nature of the game, more than 4,000 former N.F.L. players have filed a lawsuit against the league, contending that it knew hits to the head could lead to long-term brain damage but did not share that information with players. The judge in the case said Tuesday that she would hear oral arguments April 9 regarding the league's motion to dismiss the lawsuit. The family of Junior Seau, a former star linebacker who shot and killed himself last year, has also sued the N.F.L., claiming it failed to inform players about the risks of brain injury.

Pollard's counterparts on the San Francisco 49ers, safeties Dashon Goldson and Donte Whitner, considered one of the hardest-hitting tandems in the N.F.L., thought the key was not removing big hits, but making sure the hits that are delivered are legal.

"You can be vicious and you can hit people hard, but do it the right way," Whitner said. "For the most part, you know what you can and cannot do. Do you want to go out there and do the right things or do you want to make that big hit to gain a big name? That's what it comes down to."

Ravens guard Marshal Yanda said he thought the topic was so personal for Pollard because of the unique nature of being a hard-hitting defensive back, one of the positions most affected by the league's attempts to increase player safety.

"I think Bernard is frustrated because he plays a tough position where it's a bang-bang play and he's getting fined," Yanda said. "That's a tough deal as far as him playing football his whole life knowing how to play one way and then all of a sudden you have to change."

One of the few people to disagree entirely with Pollard's view that skewing the rules to protect offensive players would harm the league was Warren Sapp, a retired defensive tackle who at one point went by the Twitter handle @QBKilla. He said a desire for points would always result in defenses being limited.

"They like points," Sapp said. "I like it too. You're going to have to make some key stops here and there but it's an offensive game, no doubt about it."


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Well: Helmets for Ski and Snowboard Safety

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. They protect your head from severe injury. During the Big Air finals at the Winter X Games in Aspen, Colo., this past weekend, for instance, 23-year-old Icelandic snowboarder Halldor Helgason over-rotated on a triple back flip, landed head-first 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 attempted 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 helmeted or bare.

Interestingly, the skiers and riders who were the most likely, in general, to don 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 of 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," says 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 takeaway 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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The Consumer: The Drug-Dose Gender Gap

Written By Unknown on Selasa, 29 Januari 2013 | 13.57

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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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:


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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Biotech Firms, Billions at Risk, Lobby States to Limit Generics

In statehouses around the country, some of the nation's biggest biotechnology companies are lobbying intensively to limit generic competition to their blockbuster drugs, potentially cutting into the billions of dollars in savings on drug costs contemplated in the federal health care overhaul law.

Genentech, via Associated Press

The biological drug Avastin for cancer from Genentech.

The complex drugs, made in living cells instead of chemical factories, account for roughly one-quarter of the nation's $320 billion in spending on drugs, according to IMS Health. And that percentage is growing. They include some of the world's best-selling drugs, like the rheumatoid arthritis and psoriasis drugs Humira and Enbrel and the cancer treatments Herceptin, Avastin and Rituxan. The drugs now cost patients — or their insurers — tens or even hundreds of thousands of dollars a year.

Two companies, Amgen and Genentech, are proposing bills that would restrict the ability of pharmacists to substitute generic versions of biological drugs for brand name products.

Bills have been introduced in at least eight states since the new legislative sessions began this month. Others are pending.

The Virginia House of Delegates already passed one such bill last week, by a 91-to-6 vote.

The companies and other proponents say such measures are needed to protect patient safety because the generic versions of biological drugs are not identical to the originals. For that reason, they are usually called biosimilars rather than generics.

Generic drug companies and insurers are taking their own steps to oppose or amend the state bills, which they characterize as pre-emptive moves to deter the use of biosimilars, even before any get to market.

"All of these things are put in there for a chilling effect on these biosimilars," said Brynna M. Clark, director of state affairs for the Generic Pharmaceutical Association. The limits, she said, "don't sound too onerous but undermine confidence in these drugs and are burdensome."

Genentech, which is owned by Roche, makes Rituxan, Herceptin and Avastin, the best-selling cancer drugs in the world Amgen makes Enbrel, the anemia drugs Epogen and Aranesp, and the drugs Neupogen and Neulasta for protecting chemotherapy patients from infections. All have billions of dollars in annual sales and, with the possible exception of Enbrel, are expected to lose patent protection in the next several years.

The trench fighting at the state level is the latest phase in a battle over the rules for adding competition to the biotechnology drug market as called for in the Patient Protection and Affordable Care Act of 2010.

A related battle on the federal level is whether biosimilars will have the same generic name as the brand name product. If they did not, pharmacists could not substitute the biosimilar for the original, even if states allowed it.

Biosimilars are unlikely to be available in the United States for at least two more years, though they have been on the market in Europe for several years. And the regulatory uncertainty appears to be diminishing enthusiasm among some companies for developing such drugs.

"We're still dealing with chaos," said Craig A. Wheeler, the chief executive of Momenta Pharmaceuticals, which is developing biosimilars. "This is a pathway that neither industry nor the F.D.A. knows how to use."

Biotech drugs, known in the industry as biologics, are much more complex than pills like Lipitor or Prozac.

That makes it extremely difficult to tell if a copy of a biological drug is identical to the original. Even slight changes in the cells that make the proteins can change the drug's properties.

The 1984 law governing generics does not cover biologicals, which barely existed then. That is why it was addressed in the 2010 law.

One reason generic pills are so inexpensive is that state laws generally allow pharmacists to substitute a generic for a brand-name drug unless the doctor explicitly asks them not to. That means generic drug manufacturers need not spend money on sales and marketing.

The bills being proposed in state legislatures would expand state substitution laws to include biosimilars. So Amgen and Genentech say the bills support the development of biosimilars.


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Rescuer Appears for New York Downtown Hospital

Manhattan's only remaining hospital south of 14th Street, New York Downtown, has found a white knight willing to take over its debt and return it to good health, hospital officials said Monday.

NewYork-Presbyterian Hospital, one of New York City's largest academic medical centers, has proposed to take over New York Downtown in a "certificate of need" filed with the State Health Department. The three-page proposal argues that though New York Downtown is projected to have a significant operating loss in 2013, it is vital to Lower Manhattan, including Wall Street, Chinatown and the Lower East Side, especially since the closing of St. Vincent's Hospital after it declared bankruptcy in 2010.

The rescue proposal, which would need the Health Department's approval, comes at a precarious time for hospitals in the city. Long Island College Hospital, just across the river in Cobble Hill, Brooklyn, has been threatened with closing after a failed merger with SUNY Downstate Medical Center, and several other Brooklyn hospitals are considering mergers to stem losses.

New York Downtown has been affiliated with the NewYork-Presbyterian health care system while maintaining separate operations.

"We are looking forward to having them become a sixth campus so the people in that community can continue to have a community hospital that continues to serve them," Myrna Manners, a spokeswoman for NewYork-Presbyterian, said.

Fred Winters, a spokesman for New York Downtown, declined to comment.

Presbyterian's proposal emphasized that it would acquire New York Downtown's debt at no cost to the state, a critical point at a time when the state has shown little interest in bailing out failing hospitals.

The proposal said that if New York Downtown were to close, it would leave more than 300,000 residents of Lower Manhattan, including the financial district, Greenwich Village, SoHo, the Lower East Side and Chinatown, without a community hospital. In addition, it said, 750,000 people work and visit in the area every day, a number that is expected to grow with the construction of 1 World Trade Center and related buildings.

The proposal argues that New York Downtown is essential partly because of its long history of responding to disasters in the city. One of its predecessors was founded as a direct result of the 1920 terrorist bombing outside the J. P. Morgan Building, and the hospital has responded to the 1975 bombing of Fraunces Tavern, the 1993 and 2001 attacks on the World Trade Center, and, this month, the crash of a commuter ferry from New Jersey.

Like other fragile hospitals in the city, New York Downtown has shrunk, going to 180 beds, down from the 254 beds it was certified for in 2006, partly because the more affluent residents of Lower Manhattan often go to bigger hospitals for elective care.

The proposal says that half of the emergency department patients at New York Downtown either are on Medicaid, the program for the poor, or are uninsured.

NewYork-Presbyterian would absorb the cost of the hospital's maternity and neonatal intensive care units, which have been expanding because of demand, but have been operating at a deficit of more than $1 million a year, the proposal said.


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Super Bowl — Tom Dempsey, Former N.F.L. Kicker, Is Dealing With Dementia

Written By Unknown on Senin, 28 Januari 2013 | 13.57

JEFFERSON, La. — "He liked to hit people," Carlene Dempsey said flatly. "He didn't care if he got his bell rung."

She was referring to her Falstaffian husband, Tom Dempsey, the former N.F.L. kicker born without toes on his right foot who in November 1970 — after a long night of drinking and debauchery in the French Quarter of New Orleans — set the league record for the longest field goal in a regular-season game. The 63-yard kick lifted the New Orleans Saints to a 19-17 victory over the Detroit Lions, and in the process helped transform Dempsey into a folk hero in the city hosting the Super Bowl on Sunday, the rare Saints player to hold a prominent N.F.L. record before the Sean Payton era.

Now 66, Dempsey sat recently with his wife at the dining room table in the modest 1,500-square-foot home they share with their daughter, Ashley, and their grandson, Dylan, in this New Orleans suburb. It quickly became apparent that when reflecting upon his football career, Dempsey seemed to take more delight discussing the hits he had delivered than the kicks he had made.

He wistfully recalled how, in high school and college, if his coaches wanted someone on the opposing team knocked out, they usually called on him to deliver a teeth-rattling hit. And his eyes twinkled with glee when he talked about how the coaches he played for over the course of his 10-year N.F.L. career with the Saints, the Eagles, the Rams, the Oilers and the Bills would sometimes call on him to be the wedge buster — football's version of a kamikaze pilot — on kickoffs.

"I would hit anybody," Dempsey boasted, echoing the sentiment of Carlene, his wife of more than 40 years. "I didn't care."

The cruel irony in this is that Dempsey's love of hitting people on the football field may very well be responsible for the syndrome that is slowly depriving him of the hard-hitting memories he so delights in sharing. He is suffering from dementia.

In a recent interview, Carlene was by Dempsey's side to dutifully and lovingly act as fact-checker and blank filler. A couple of times, she prompted him to share a story she knew he would be keen to share. She also did not hesitate to step in and correct him when it appeared his memory was failing him.

"I went to Encinitas High School," he said at one point. That prompted Carlene to say, "No, honey, you went to San Dieguito High School in Encinitas, remember?" He replied, "Oh yeah, that's right."

Dr. Daniel Amen, a brain disorder specialist who has done extensive studies on football players, made the initial diagnosis of Dempsey. He said he was astonished by the amount of damage he noticed in his brain after getting back the results of some scans.

"I wondered, Why does this kicker's brain look not so good?" Amen said in a phone interview. "Because I was thinking that kickers should have the best-looking brains. But he didn't."

What Amen later learned is that bygone-era kickers like Dempsey, who was listed at 6 feet 2 inches and 255 pounds, did things on the field that are pretty much unheard-of today: they played other positions on offense and/or defense, as Dempsey did in high school and college, not to mention being vital components on special-teams units — unlike modern kickers, who usually get near a return man only if he manages to get past the 10 other guys on the coverage team, and that is only if the kickoff does not sail out of the end zone for a touchback.

After being kicked off the football team at Palomar College for punching one of his coaches, Dempsey was brought into the N.F.L. by Vince Lombardi and the Green Bay Packers in the hopes of turning him into a kicker/offensive lineman in the mold of Lou Groza. But for the first time in his football life, Dempsey was heavily outmatched physically by the famed monsters on the Packers' defensive line.

"I got beat up pretty bad every day in practice," said Dempsey, who never played a game in a Packers uniform. It was then, he says, that he decided, after a stint playing for a semipro team in Massachusetts, that he wanted to focus exclusively on being a kicker. But again, that did not stop him from hitting people on the football field.

Over the course of his career, the Dempseys say, Tom had three concussions that were diagnosed, but that several others likely went undiagnosed. They recalled one game in which Dempsey, after laying a jarring hit on someone after kicking off, was so disoriented that he ran to the wrong sideline and grabbed a seat on the opposing team's bench. He had to be shown back to his place across the field by an equipment manager, and he later returned to the game.


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Dave Purchase, Who Led Needle-Exchange Movement, Dies at 73

Dave Purchase, a bearded biker who 24 years ago began handing out sterile syringes to prevent AIDS among drug addicts on the streets of Tacoma, Wash., and went on to become a national leader of the needle-exchange movement, died on Jan. 21 in Tacoma. He was 73.

The cause was complications of pneumonia, said his son, Dylan.

With a borrowed television tray and a folding chair that he set up on a downtown street steps away from a heroin den, Mr. Purchase began handing out syringes, bottles of bleach, cotton swabs and condoms in the summer of 1988. Within five months he had exchanged 13,000 clean needles (most of them bought at his own expense) for dirty ones — and was gaining wide attention from the news media.

"How does this work?" a toothless addict asked him, The New York Times reported in January 1989.

"You give me an old one, I give you a sterile one, and it keeps your butt alive," Mr. Purchase responded.

Mr. Purchase would trade as many as 10 needles at a time, while also handing out cookies and mittens.

By 1993 he had founded both the Point Defiance AIDS Project, with support from the Tacoma-Pierce County Health Department, and the North American Syringe Exchange Network. The network, which buys syringes wholesale and sells them at cost to programs across the country, now distributes more than 15 million syringes annually.

Articles over the years have cited Mr. Purchase's 1988 street-corner operation as the first exchange in the nation. Ethan Nadelmann, the executive director of the Drug Policy Alliance, which promotes alternatives to harsh legal treatment of drug users, could not confirm that.

"Whether or not he was literally the first to hand out syringes to stop AIDS, he was undoubtedly the godfather of needle exchange in America," Mr. Nadelmann said in an interview. "He was a mentor and adviser to activists and public health workers around the world."

In the early days of the AIDS epidemic, when many critics argued that needle exchanges encouraged drug use, Mr. Purchase "was able to get political acceptance in Tacoma and obtain public funding," said Don Des Jarlais, the director of research for the Chemical Dependency Institute at Beth Israel Medical Center in Manhattan.

When Mr. Purchase set up shop, he was without official government sanction or financial backing and, he said, was prepared to go to jail for 90 days for the misdemeanor offense of possessing drug paraphernalia. But he soon received support from the Tacoma police chief, Ray Fjetland, who suspended enforcement of the syringe law.

Mr. Purchase also worked closely with the county health department. The program became something of a model.

By 2011, according to a survey by Dr. Des Jarlais, there were 197 known needle-exchange programs in 36 states, the District of Columbia and Puerto Rico. That year, those exchanges distributed more than 36 million syringes.

"Given that over the course of the epidemic there have been several million people who injected drugs," Dr. Des Jarlais said, "the efforts of Dave and people like him have literally saved hundreds of thousands of lives."

In a way, David Joe Purchase found his calling on a Harley-Davidson. Born in Tacoma on Aug. 29, 1939, to Kenneth and Bernice Purchase, he was something of a rebel as a youngster. He worked at several jobs after dropping out of college.

"My dad was a biker, with the big beard, the black leather jacket," Mr. Purchase's son said. "Because of that look, he started assisting a friend who was a drug counselor who would send him around town when clients went missing — into bars, down an alley."

Mr. Purchase was nearly killed in 1983 when a drunken driver crashed into his motorcycle. After a long rehabilitation, he returned to work as a drug counselor and soon realized that many of his clients were dying of AIDS. He used $3,000 from a settlement from the accident to buy syringes and set up his table.

Mr. Purchase's marriages, to Sally Riewald and Sue Powers, ended in divorce. Beside his son, he is survived by a daughter from his first marriage, Rebecca Ford; two stepsons, Blake Barry and Kelly Powers; a stepdaughter, Krista Townsend; a sister, Karen Robinson; and three step-grandchildren.

In 2006, Mr. Purchase told The News Tribune in Tacoma that he would never consider giving up his work.

"I'd have to live with that," he said. "This is life and death. There were unnecessary deaths, unnecessary and preventable deaths."


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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: 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:

¶ 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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40 Years After Roe v. Wade, Thousands March to Oppose Abortion

Written By Unknown on Minggu, 27 Januari 2013 | 13.57

Drew Angerer/The New York Times

Pro-life activists made their way down Constitution Avenue toward the Supreme Court during the March for Life in Washington on Friday.

WASHINGTON — Three days after the 40th anniversary of the decision in Roe v. Wade, the landmark Supreme Court case that legalized abortion, tens of thousands of abortion opponents from around the country came to the National Mall on Friday for the annual March for Life rally, which culminated in a demonstration in front of the Supreme Court building.

On a gray morning when the temperature was well below freezing, the crowd pressed in close against the stage to hear more than a dozen speakers, who included Tony Perkins, the president of the Family Research Council; Representative Diane Black, Republican of Tennessee, who recently introduced legislation to withhold financing from Planned Parenthood, and Senator Rand Paul, Republican of Kentucky; Cardinal Seán Patrick O'Malley of Boston; and Rick Santorum, the former senator from Pennsylvania and Republican presidential candidate.

Mr. Santorum spoke of his wife's decision not to have an abortion after they learned that their child — their daughter Bella, now 4 — had a rare genetic disorder called Trisomy 18.

"We all know that death is never better, never better," Mr. Santorum said. "Bella is better for us, and we are better because of Bella."

Jeanne Monahan, the president of the March for Life Education and Defense Fund, said that the march was both somber and hopeful.

"We've lost 55 million Americans to abortion," she said. "At the same time, I think we're starting to win. We're winning in the court of public opinion, we're winning in the states with legislation."

Though the main event officially started at noon, the day began much earlier for the participants, with groups in matching scarves engaged in excited chatter on the subway and gaggles of schoolchildren wearing name tags around their necks. Arriving on the Mall, attendees were greeted with free signs ("Defund Planned Parenthood" and "Personhood for Everyone") and a man barking into a megaphone, "Ireland is on the brink of legalizing abortion, which is not good."

The march came two months after the 2012 campaign season, in which social issues like abortion largely took a back seat to the focus on the economy. But the issue did come up in Congressional races in which Republican candidates made controversial statements about rape or abortion. In Indiana, Richard E. Mourdock, a Republican candidate for the Senate, said in a debate that he believed that pregnancies resulting from rape were something that "God intended," and in Illinois, Representative Joe Walsh said in a debate that abortion was never necessary to save the life of the mother because of "advances in science and technology." Both men lost, hurt by a backlash from female voters.

Recent polls show that while a majority of Americans do not want Roe v. Wade to be overturned entirely, many favor some restrictions. In a Gallup poll released this week, 52 percent of those surveyed said that abortions should be legal only under certain circumstances, while 28 percent said they should be legal under all circumstances, and 18 percent said they should be illegal under all circumstances. In a Pew poll this month, 63 percent of respondents said they did not want Roe v. Wade to be overturned completely, and 29 percent said they did — views largely consistent with surveys taken over the past two decades.

"Most Americans want some restrictions on abortion," Ms. Monahan said. "We see abortion as the human rights abuse of today."

Speaker John A. Boehner of Ohio, who spoke via a recorded video, called on the protest group, particularly the young people, to make abortion "a relic of the past."

"Human life is not an economic or political commodity, and no government on earth has the right to treat it that way," he said.

The crowd was dotted with large banners, many bearing the names of the attendees' home states and churches and colleges. Gary Storey, 36, stood holding a handmade sign that read "I was adopted. Thanks Mom for my life." Next to him stood his adoptive mother, Ellen Storey, 66, who held her own handmade sign with a picture of her six children and the words "To the mothers of our four adopted children, 'Thank You' for their lives."

Mr. Storey said he was grateful for the decision by his biological mother to carry through with her pregnancy. "Beats the alternative," he joked.

Last week, the Planned Parenthood Federation of America started a new Web site, and on Tuesday, its president, Cecile Richards, released a statement supporting abortion rights.

"Planned Parenthood understands that abortion is a deeply personal and often complex decision for a woman to consider, if and when she needs it," she said. "A woman should have accurate information about all of her options around her pregnancy. To protect her health and the health of her family, a woman must have access to safe, legal abortion without interference from politicians, as protected by the Supreme Court for the last 40 years."

This article has been revised to reflect the following correction:

Correction: January 25, 2013

A summary that appeared on the home page of NYTimes.com with an earlier version of this article misstated the day of the march. It took place on Friday, not Thursday.


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Diner’s Journal Blog: PepsiCo Will Halt Use of Additive in Gatorade

PepsiCo announced on Friday that it would no longer use an ingredient in Gatorade after consumers complained.

The ingredient, brominated vegetable oil, which was used in citrus versions of the sports drink to prevent the flavorings from separating, was the object of a petition started on Change.org by Sarah Kavanagh, a 15-year-old from Hattiesburg, Miss., who became concerned about the ingredient after reading about it online. Studies have suggested there are possible side effects, including neurological disorders and altered thyroid hormones.

The petition attracted more than 200,000 signatures, and this week, Ms. Kavanagh was in New York City to tape a segment for "The Dr. Oz Show." She visited The New York Times on Wednesday and while there said, "I just don't understand why they can't use something else instead of B.V.O."

"I was in algebra class and one of my friends kicked me and said, 'Have you seen this on Twitter?' " Ms. Kavanagh said in a phone interview on Friday evening. "I asked the teacher if I could slip out to the bathroom, and I called my mom and said, 'Mom, we won.' "

Molly Carter, a spokeswoman for Gatorade, said the company had been testing alternatives to the chemical for roughly a year "due to customer feedback." She said Gatorade initially was not going to make an announcement, "since we don't find a health and safety risk with B.V.O."

Because of the petition, though, Ms. Carter said the company had changed its mind, and an unidentified executive there gave Beverage Digest, a trade publication, the news for its Jan. 25 issue.

Previously, a spokesman for PepsiCo had said in an e-mail, "We appreciate Sarah as a fan of Gatorade, and her concern has been heard."

Brominated vegetable oil will be replaced by sucrose acetate isobutyrate, an emulsifier that is "generally recognized as safe" as a food additive by the Food and Drug Administration. The new ingredient will be added to orange, citrus cooler and lemonade Gatorade, as well Gatorade X-Factor orange, Gatorade Xtremo citrus cooler and a powdered form of the drink called "glacier freeze."

Ms. Carter said consumers would start seeing the new ingredient over the next few months as existing supplies of Gatorade sell out and are replaced.

Health advocates applauded the company's move. "Kudos to PepsiCo for doing the responsible thing on its own and not waiting for the F.D.A. to force it to," said Michael Jacobson, executive director of the Center for Science in the Public Interest.

Mr. Jacobson has championed the removal of brominated vegetable oil from foods and beverages for the last several decades, but the F.D.A. has left it in a sort of limbo, citing budgetary constraints that it says keep it from going through the process needed to formally ban the chemical or declare it safe once and for all.

Brominated vegetable oil is banned as a food ingredient in Japan and the European Union. About 10 percent of drinks sold in the United States contain it, including Mountain Dew, which is also made by PepsiCo; some flavors of Powerade and Fresca from Coca-Cola; and Squirt and Sunkist Peach Soda, made by the Dr Pepper Snapple Group.

PepsiCo said it had no plans to remove the ingredient from Mountain Dew and Diet Mountain Dew, both of which generate more than $1 billion in annual sales.

Heather White, executive director at the Environmental Working Group, said of PepsiCo's decision, "We can only hope that other companies will follow suit." She added, "We need to overhaul how F.D.A. keeps up with the latest science on food additives to better protect public health."

Ms. Kavanagh agreed. "I've been thinking about ways to take this to the next level, and I'm thinking about taking it to the F.D.A. and asking them why they aren't doing something about it," she said. "I'm not sure yet, but I think that's where I'd like to go with this."


This post has been revised to reflect the following correction:

Correction: January 26, 2013

An earlier version of this article misspelled the surname of the 15-year-old who started a petition on Change.org to end the use of brominated vegetable oil in Gatorade. She is Sarah Kavanagh, not Kavanaugh.

A version of this article appeared in print on 01/26/2013, on page B1 of the NewYork edition with the headline: PepsiCo Will Halt Additive Use In Gatorade.

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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.

More than 45 lawsuits have been filed in federal courts challenging the contraceptive coverage requirement of the Affordable Care Act.

Most come from religiously-affiliated institutions and remain largely suspended while the government tries to offer a compromise.

More than a dozen suits are from private companies that do things like run mines, sell crafts and ship produce.

Of those, nine companies have received some form of temporary relief while the cases prepare for trial; five lawsuits have been rejected.

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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