Category Archives: healthy

Home Health Care: Shouldn’t It Be Work Worth Doing?

Home Health Care: Shouldn’t It Be Work Worth Doing?

Do you know who is going to care for you when you are old and frail? By current standards, it’s likely to be a middle-aged immigrant woman, with maybe a high school education and little if any training, making $20,000 a year.

And that’s if you are lucky. If you live in rural America, you may already have a hard time finding somebody to look after you. Paul Osterman of the Massachusetts Institute of Technology’s Sloan School of Management calculates that if nothing is done to draw more workers into the field, there will be a shortage of at least 350,000 paid care providers by 2040.

This, I’m sure you’ll agree, makes little sense.

How to provide long-term care for a fast-aging population poses one of the more convoluted challenges of the American labor market. Care providers — home health aides, personal care attendants and certified nursing assistants, in the government’s classification — are expected to be among the nation’s fastest-growing occupations. The Department of Labor’s economists expect about a million more will be added from 2014 to 2024.

And yet despite their critical importance to the well-being of tens of millions of aging Americans, one-fourth of these aides live in poverty. The jobs are so unappealing that it is hard to keep workers in them: four in 10 leave the occupation entirely within a year. Many prefer the fast-food business.

“Home care is absolutely the bottom rung on the ladder, but home-care workers are the people that spend the most time with the client,” said Adria Powell, who runs Cooperative Home Care Associates, a worker-owned long-term-care agency in New York.

As President Trump promises to recover the jobs of an ancestral age populated by well-paid coal miners, steelworkers and assemblers of air-conditioners, he is missing one of the most critical challenges of the American work force: transforming long-term care into a higher-quality, better-paid job that could support the middle class of the future.

It can be done. In his new book, “Who Will Care For Us?,” to be published next month by the Russell Sage Foundation, Professor Osterman suggests that improving these jobs could actually improve the quality and efficiency of the entire health care system. “It could save the system money,” he told me.

There are a few reasons long-term care is such a bad job. “Most people see it as glorified babysitting,” said Robert Espinoza, vice president for policy at PHI, an advocacy group for personal care workers that also develops advanced training curriculums to improve the quality of the work force.

The fact that most workers are immigrant women does not help the occupation’s status. Occupational rules that reserve even simple tasks for nurses, like delivering an insulin shot or even putting drops into a patient’s eye, also act as a barrier against providing care workers with better training.

But perhaps the most important barrier is the government’s budget: Medicaid — funded by federal and state governments — picks up more than half the tab for the $300 billion or so spent every year on long-term care.

States spend about $200 billion of their own funds on Medicaid. It is the second-biggest item on their budget, after education. To raise reimbursement rates for long-term care agencies, they would have to find the money elsewhere.

Still, Professor Osterman points out that shortchanging long-term care is shortsighted. Home health aides trained to do more — to spot patients’ health problems, to keep track of their pills and doctors’ appointments and to offer advice on healthy living — could wring billions of dollars in savings from the health care system.

Better-trained aides could help patients manage chronic conditions like obesity and diabetes. They could also help manage the transition out of a hospital, ensuring that patients took their medication and followed up with the doctor, to prevent them from having a relapse or ending up in a nursing home.

Maria Soto , left, receiving instruction from Marisol Rivera, a senior aide at Cooperative Home Care Associates. Credit Hiroko Masuike/The New York Times

One assessment of the academic literature concluded that there are $250 billion in savings to be had from better managing chronic conditions and reducing hospital and emergency room admissions and readmissions.

And there are other jobs for personal care aides to do. For instance, community health workers doing home visits can help bridge the gap between patients and doctors — improving rates of immunization, helping manage conditions like high blood pressure and otherwise encouraging healthy behaviors.

Marisol Rivera offers a glimpse at how this could be done. After 16 years as an aide for Cooperative Home Care Associates, she was promoted to senior aide, assisting less-experienced aides in the field. She reminds them how to use the Hoyer lift to get patients out of bed and into their wheelchair. She keeps tabs on hospital discharge papers to make sure patients — which the firm calls members — make their next doctor’s appointment. “Most of time the reason members go back to hospital is because they don’t check back with the doctor,” Ms. Rivera said.

Ms. Rivera offers some hope for the profession. Her hourly wage went from $11 to more than $15. Still, her situation is rare. Worker-owned Cooperative Home Care Associates has only two senior aides like her. What’s more, she says, “I still live week by week.”

Changing the system of long-term care, to give more responsibilities to better-trained, higher-paid aides will not be easy. For starters, there is the awkward question of the distribution of costs and benefits. Medicaid pays for most long-term care, but Medicare would reap most of the potential cost savings from things like fewer hospital readmissions.

Cash-short states have resisted efforts to raise aides’ pay. Worried that overtime rules would break their budget, some opposed the Obama administration’s effort to cover home care aides under the Fair Labor Standards Act, from which they had been excluded based on the outdated argument that they were little more than babysitters.

Then there are the powerful nursing unions, ready to fight tooth and nail to keep aides from encroaching on their turf. Carol Raphael, former chief executive of the Visiting Nurse Service of New York, the largest home health agency in the United States, told Professor Osterman that when the association tried to expand the role of home-care aides, the “nurses went bonkers.”

Even advocates for older Americans have lobbied against tighter rules covering things like training for long-term care workers. Many of them also opposed covering aides under the Fair Labor Standards Act, as states facing overtime payments might cap the workweek for aides at 40 hours. If a relative were caring for you and the government said that she could work for only 40 hours, how would you get more hours if you needed them?

Still, overhauling long-term care seems within reach. Penalties for excessive readmissions are already encouraging hospitals to rethink the role of home-care aides. And Obamacare is changing the health care industry in ways that would support a better-trained, better-paid home-care work force, pushing providers to manage the overall health of patients rather than offer health services for a fee.

“There is a light bulb that is sort of going off,” Ms. Powell said. “Shouldn’t we figure out how to leverage this work force and invest in this work force to reduce hospitalization, to reduce E.R. visits, to manage chronic diseases that are so expensive?”

This is encouraging the formation of health teams, in which long-term-care aides — who are cheaper than doctors or nurses — could have a larger role in managing patients’ well-being.

You might think of it in terms of demographics. By 2040, there will be more than 50 million disabled people in the United States needing some form of long-term care, 12 million more than today. Most will be cared for by family members, but the demand for care workers will explode.

It makes sense for these workers to be better trained and empowered to offer better care. If nothing is done to improve the quality of their jobs, many will go unfilled — losing the competition for workers with McDonald’s.

In the end, the issue is not just who will care for you when you are old and frail. The broader issue is what American society will look like then. Because these are the jobs of America’s future. And America will look much better if they can sustain a middle class.

Breast-Feeding May Lower Risk of Endometriosis

Breast-Feeding May Lower Risk of Endometriosis

Breast-feeding is linked to a reduced risk for endometriosis, a new study reports.

Endometriosis — the growth of uterine tissue outside the uterus — can cause severe pain and excessive bleeding during menstruation, among other problems. It is a chronic disorder with an unknown cause.

Researchers studied 72,394 women who had had one or more pregnancies. There were 3,296 diagnoses of endometriosis among them. Compared with women who nursed for less than a month per pregnancy, those who nursed for a year or more had a 32 percent reduced risk for endometriosis. For each additional three months of nursing, they reduced their risk by 8 percent.

The study, in BMJ, controlled for body mass index, smoking, oral contraceptive use, age at menarche and other factors, but it depended on self-reports of breast-feeding, which are not always reliable.

The mechanism remains unclear, but women who stopped having periods for a time after giving birth also reduced their risk, and breast-feeding prolongs the pause in menstruation. Still, menstrual delay accounted for only a portion of the effect.

“Understanding risk factors for endometriosis that are modifiable is really important,” said the lead author, Leslie V. Farland, a research scientist at Brigham and Women’s Hospital in Boston. “And our finding builds on what we already know about breast-feeding — that it’s very beneficial for both the child and the mother.”

Hormone Treatment for Prostate Cancer Tied to Heart Risks

Hormone Treatment for Prostate Cancer Tied to Heart Risks

A common treatment for prostate cancer may increase the risk for heart disease.

A study in the British Journal of Cancer identified 7,637 men in California who had new diagnoses of localized prostate cancer from 1998 to 2008 and followed them through 2010.

About 30 percent of the men received androgen deprivation therapy, or A.D.T., a drug treatment that deprives prostate cancer cells of male sex hormones, which encourage their growth.

Men who did not have pre-existing cardiovascular disease who underwent A.D.T. had an 81 percent increased relative risk for heart failure compared with men who did not get the drug regimen. They also had slightly increased risks for heart rhythm disorders.

Men treated with A.D.T. who already had cardiovascular disease were also at higher risk for heart rhythm and conduction disorders compared to heart patients who did not get the drugs.

The study controlled for race, age, prostate tumor characteristics, other medications and cardiovascular risk factors.

The lead author, Reina Haque, a research scientist at Kaiser Permanente in Pasadena, Calif., said that the results could be particularly important for prostate patients who have risk factors for heart disease. The study, she said, provides “a way to begin a conversation about whether A.D.T. is a treatment you should use.”

Gilead to Buy Kite, Maker of Cancer Treatments, for $11.9 Billion

The drugmaker Gilead Sciences said on Monday that it would buy Kite Pharma for about $11.9 billion to bolster its aging portfolio with an emerging cancer treatment.

The acquisition, Gilead’s first major deal since 2011, is a departure from the path followed by the broader pharmaceutical industry, where — apart from Johnson & Johnson’s $30 billion takeover of the Swiss biotechnology company Actelion — the pace of acquisitions had largely slowed this year. Many drugmakers that had been busy with takeover activity in recent years have since been at work integrating their purchases.

Under the terms of the agreement, Gilead will pay $180 a share in cash, a 29 percent premium to Kite’s closing price on Friday.

With the deal, Gilead would acquire Kite’s new cancer-fighting method, which harnesses the body’s immune system to attack malignant cells. Kite’s most promising treatment, for non-Hodgkin lymphoma, is expected to receive government approval within the next year.

“The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers,” John F. Milligan, Gilead’s chief executive, said in a statement.

Large pharmaceutical companies have traditionally made a substantial impact on deal-making activity in the wider health care sector, using acquisitions of smaller drugmakers with promising treatments rather than spending billions of dollars on research and development.

Gilead, which made its name selling treatments for H.I.V. and hepatitis C, has been seeking to strike a deal for some time as it hunted for the next big drug: Its business has faced pressure amid competition in the market for hepatitis C treatments. Gilead’s revenue from sales of those drugs dropped in the second quarter this year to $2.9 billion, compared with $4 billion a year before.

Gilead shares had fallen nearly 8 percent in the 12 months that ended last week, as investors worried that the company had not yet found a suitable addition to its product pipeline.

In November, however, the company’s chief financial officer, Robin L. Washington, told analysts: “We have a healthy balance sheet to invest in our pipeline and external opportunities.”

As of June 30, Gilead reported having $21.6 billion in cash and short-term investments.

The acquisition of Kite would be Gilead’s biggest purchase, surpassing its $11 billion deal for Pharmasset in 2011, according to Standard & Poor’s Global Market Intelligence.

Questions remain about Kite’s prospects, as Novartis and other rivals rush to bring similar cancer treatments to market.

The deal is expected to close by the end of the year.

Gilead took advice from Bank of America Merrill Lynch, Lazard and the law firm Skadden, Arps, Slate, Meagher & Flom. Kite worked with Centerview Partners, Jefferies, Cowen and Company and the law firms Sullivan & Cromwell and Cooley.

With a Simple DNA Test, Family Histories Are Rewritten

Bob Hutchinson’s mother told him and his siblings almost nothing about her family, no matter how often they asked. “She was good at brushing people off,” said Mr. Hutchinson, 60.

Growing up, there were no photos of his mother as a child in the home, or of her own parents. She said that she was an only child, that her parents were dead. Her heritage, she claimed, was Italian and Swedish.

Mr. Hutchinson suspected there was more to the story. Then his sister-in-law, digging into the family past, found his mother’s childhood home listed in a 1930 census.

The family had lived in Montclair, N.J., and was described as “Negro.” Mr. Hutchinson, who runs an advertising agency and lives in Pacifica, Calif., had never been told he had African-American heritage.

These days, family secrets like this one are becoming harder to keep.

A growing number of companies now offer DNA tests that promise to pinpoint a customer’s heritage and, with permission, to identify genetic relatives. The firms include generalists like 23andMe and Ancestry.com and specialty companies like African Ancestry.

Millions of people have signed up for the tests, sending saliva samples to laboratories and paying $100 to $350 or more for an analysis.

The customers are eager to know where they came from, to find a familial context that may be lacking. The answers hidden in DNA can be revelatory, shedding light on hidden events occurring decades earlier and forever changing the family narrative.

The Best DNA Test Kits

The Wirecutter, a product review site owned by The New York Times Company, analyzed at-home DNA test kits and has a guide to the finding the best ones.

But a new analysis of DNA test kits by The Wirecutter, a review site owned by The New York Times, finds that the services also have limitations that the providers do not always fully acknowledge.

Mr. Hutchinson decided to have his DNA analyzed by 23andMe. The report revealed he is one-eighth sub-Saharan African, which means that his mother was of mixed race. There was some Italian and Swedish heritage.

Mr. Hutchinson also learned that his mother was not an only child, but had a brother. A genealogist helped him track down some first cousins in Alabama, who said they had been told never to contact Mr. Hutchinson or his family.

The cousins were delighted to hear from him. He plans to visit next year at Mardi Gras.

Mr. Hutchinson’s results were enlightening, but in other contexts ethnicity has posed a particularly knotty problem for DNA testing firms. The very definitions of “race” and “ethnicity” are fuzzy, said Joseph Pickrell, a computational geneticist at the New York Genome Center laboratory, affiliated with Columbia University.

“Different people mean different things when they say ‘race,’” he said. In the United States, for example, a person with almost any African ancestry often is identified as black.

“That’s not necessarily the case in other parts of the world,” Dr. Pickrell said.

Researchers at 23andMe acknowledged the difficulty in a recent paper, writing, “It is important to note that ancestry, ethnicity, identity and race are complex labels that result both from visible traits, such as skin color, and from cultural, economic, geographical and social factors.”

In a recent study, the researchers decided to use Census Bureau definitions — black, white, Hispanic — to ask how often people who identify as one race actually have genetic markers indicating a mixed heritage.

After examining data from 160,000 customers who agreed to participate, the geneticists learned that 3.5 percent of those who said they were white actually had DNA that was 1 percent or more African in origin.

The chances of having African ancestry were highest in the South, and highest of all in South Carolina, where at least 13 percent of those who said they were white had African ancestors.

Among those who said they were black, genetic ancestry over all was 73.2 percent African, 0.8 percent Native American and 24 percent European. Experts say the large proportion of European DNA found in African-Americans can be traced to before the Civil War, and the rape of enslaved African women.

Mr. Hutchinson’s family photographs. Through the genetic testing service 23andMe, Mr. Hutchinson learned that his mother had a brother and a sister, and a genealogist helped him track down some first cousins in Alabama, who said they had been told never to contact Mr. Hutchinson or his family. Credit Brian Flaherty for The New York Times

The ancestry of those who said they were Hispanic was something of a hodgepodge. Some had no Native American ancestry; others had 50 percent or more.

Hispanics living in the South tended to have more African ancestry. As a group, their DNA was 6.2 percent African, 18 percent Native American and 65.1 percent European.

Jewish ancestry, on the other hand, is far easier to discern. Historically, these populations were small and Jews tended not to marry outsiders. As a result, they share telltale sequences of DNA, easily identified by testing.

But is this sort of ethnic categorization really instructive? Human beings share more than 99.9 percent of their DNA; what makes us different is vanishingly insignificant in terms of genetics.

If testing “tells me I’m 95 percent Ashkenazi Jewish and 5 percent Korean, is that really different from 100 percent Ashkenazi Jewish and zero percent Korean?” Jonathan Marks, an anthropology professor at the University of North Carolina at Charlotte, wondered in The Wirecutter.

The question of ethnicity is enmeshed with another difficult challenge for DNA testers: geography.

Genetics researchers generally know which DNA sequences originated on which continents. But pinpointing a particular country of origin, as many testing services claim to do, is far trickier.

Scientists simply do not have good data on the genetic characteristics of particular countries in, say, East Africa or East Asia. Even in more developed regions, distinguishing between Polish and, for instance, Russian heritage is inexact at best.

The precise numbers offered by some testing services raise eyebrows among genetics researchers. “It’s all privatized science, and the algorithms are not generally available for peer review,” Dr. Marks said.

“That’s why their ads always specify that this is for recreational purposes only: lawyer-speak for, ‘These results have no scientific standing.’”

For many, though, the point of DNA testing has nothing to do with ethnicity. Theresa Musumeci, 49, of Hockessin, Del., wanted to solve a longstanding mystery in her family. Who was her biological grandmother?

Mr. Hutchinson’s cousins Sandra Green, left, and Eve Clark. Ms. Green and Ms. Clark are mail carriers in Daphne, Ala., and Mr. Hutchinson has plans to join them for Mardi Gras next year. Credit Bryan Tarnowski for The New York Times

Decades ago, Ms. Musumeci’s mother had discovered she had been adopted after she overheard the nuns at her Catholic high school in Camden, N.J., talking about it.

For years, she searched for clues to her birth mother’s identity, eventually learning her name: Mary Culliton. But Ms. Musumeci’s mother died in 1995, at 55, without learning much more.

Ms. Musumeci decided to continue the quest by submitting a sample to Ancestry.com, which also will notify users of relatives in its database if they have given permission.

Among the matches were Ms. Musumeci’s half brother and a few well-known cousins — but also a man she had never heard of. His great-aunt, it turned out, was Ms. Musumeci’s great-grandmother — Mary Culliton’s mother. He filled her in on the woman’s life.

Eventually Ms. Musumeci discovered other long-lost aunts and uncles. “I found five great family members,” she said. Yet there is one regret: Her mother did not survive long enough to learn the story.

“I feel bad that the technology was not available for her,” Ms. Musumeci said.

If DNA testing has the potential to shed light on new family relationships, it also can muddy those that had seemed settled. While putting together The Wirecutter’s own report, one researcher learned that a grandparent was in fact not biologically related.

Such news can be burdensome — or freeing.

Mark, a banker in Delaware, got his test results back from Ancestry.com along with a list of relatives in its database. Oddly, there was no one on the list from his father’s side of the family.

There was one name he recognized, though: his father’s best friend. Who, it turned out, actually was his biological father.

Mark, 43, whose last name was withheld to protect his family’s privacy, is estranged from his mother, and the man he knew as his father died more than a decade ago. So he reached out to his father’s best friend, who confirmed an affair with his mother decades ago.

The two live near each other and have gotten together several times recently. The secret that the older man thought he would take to his grave is well out of the bag.

On one recent outing, Mark said, “he even showed me the place where I probably was conceived.”

Correction: 
An earlier version of this article incorrectly described the family of Bob Hutchinson, who discovered relatives he did not know of following a DNA test. He has just one sibling, not two, and his mother had just one sibling, not two. The article also incorrectly described the person who began investigating the family’s history. It was Mr. Hutchinson’s sister-in-law, not his sister. In addition, the article misstated the results of the test. He was found to be one-eighth African American, not one-quarter, and to have some Swedish and Italian heritage, not none.

Can Your ‘Good’ Cholesterol Be Too High?

Can Your ‘Good’ Cholesterol Be Too High?

High levels of HDL, or “good” cholesterol, are generally considered healthy. But can you have too much of a good thing?

Possibly so, a study in the European Heart Journal found. Danish researchers tracked more than 116,508 men and women, average age 57, for an average of six years. There were 10,678 deaths.

After adjusting for other factors, an HDL of 73 milligrams per deciliter in men and 93 in women was associated with the lowest all-cause mortality. Compared with that, men with HDL levels of 97 to 115 had a 36 percent increased risk for death, and twice the risk above 116. Women at greater than 135 had a 68 percent increased risk. (Only 2.3 percent of men had levels above 97, and 0.3 percent of women had levels above 135.)

Low HDL, too, was tied to higher mortality risk, consistent with other studies. At levels under 39, the lower the HDL, the greater the increased risk for death.

The senior author, Dr. Borge G. Nordestgaard, a clinical professor at the University of Copenhagen, said that until now, he would “congratulate” patients with very high HDL. “The higher the better!”

“But now we know that’s not so. These people should protect themselves — exercise, stop smoking, eat a healthy diet and so on.”

Safer Cars Help Keep Older Drivers on the Road

Safer Cars Help Keep Older Drivers on the Road

More than three decades ago, I fell in love with the first minivan I spotted parked in my Brooklyn neighborhood. Though I was never a “soccer mom,” I travel as if there were no stores at my destination, and here was a car that could carry half a household. And I loved sitting up high, able to see beyond the car in front of me.

Now four minivans later, I’ve downsized. At the urgings of a son and daughter-in-law concerned about keeping me alive on the road, I got a car with a long list of safety features – in my case, a Subaru Outback – that would have all the bells and whistles to compensate for any driving-related losses I may have suffered since getting a license 56 years ago.

Yes, after 10 years in a Toyota Sienna that I adored, there will be a steep learning curve. But driving home from the Subaru dealer with the lane departure feature activated, I immediately saw one benefit: The car beeped me and displayed a visual image every time I got too close to either side of my lane when I wasn’t signaling a turn. Backing out of a parking lot, the dashboard backup camera assured me that I wasn’t about to hit another car or pedestrian, though I also used my eyes and mirrors as added insurance.

Given the tsunami of baby boomers and their predecessors still driving, the auto industry anticipated a need for vehicles with features that can enable people like me to remain independent and easily connected to distant friends, family and favored places.

When a crash occurs involving an older driver, it tends to garner media attention, whereas the same accident with a younger driver would not. “That’s unfair to the general population of older adults, who are among the safest drivers on the road,” said Jacob Nelson, the director of traffic safety advocacy and research at AAA.

After years of advising others on how to get older drivers to relinquish the car keys, which often resulted in lost independence, isolation and depression (as well as family disputes), driving experts like Mr. Nelson now focus on helping the elderly select vehicles that can accommodate their physical disabilities and certain sensory or cognitive losses.

As Elin Schold Davis, coordinator of the Older Driver Initiative of the American Occupational Therapy Association, put it, “It’s not about taking away the keys based on age, it’s about function.” The current approach is “to support people to enable them to drive as long as possible” without unduly endangering themselves or anyone else.

Ms. Schold Davis highly recommended a $400 consultation with an occupational therapy driving rehabilitation specialist “as perhaps the best investment to make before selecting features in a car to best fit your health and physical issues.”

“There’s no such thing as the best car for an older person,” Mr. Nelson said. “What matters are the features, and the features appropriate for one older driver are not necessarily appropriate for another.”

For example, as someone with arthritic hands (among other body parts), I’m aided by power seats that can be preset two ways: one for my best driving position and the other to ease entry and exit from the car. Other useful features include power windows and mirrors, a thicker steering wheel that is easier to grip, keyless entry, an automatic tailgate closer and a push-button to start (and stop) the engine.

However, Mr. Nelson warned drivers of all ages about one feature now in most new cars: the backup camera. While great for older adults with flexibility issues and short people like me who can’t see objects directly behind the car, it won’t detect anything in the blind spot. That is, it cannot see people, vehicles or bicycles approaching the car from the side. The camera is meant to supplement, not replace, a driver’s visual checks. You must still check your mirrors, turn your head if possible and proceed with caution.

The AAA has created a very useful computerized site to help older drivers identify the makes and models of vehicles within various price ranges that may best suit their particular issues. At SeniorDriving.AAA.com/SmartFeatures, drivers can use drop-down menus to choose among categories like diminished vision, limited upper body range of motion, short stature or overweight, and decreased leg strength.

For those with various vision problems common among the elderly, for example, features like a high-contrast instrument panel with large number and letter displays, an auto-dimming rearview mirror and glare-reducing side mirrors can enhance driver safety.

Sometimes features that auto engineers consider helpful are annoying or distracting for some drivers. Several of the visual or audible warnings in my new car can be turned on or off by the driver.

Ms. Schold Davis urged people to “plan to spend time choosing a car and select the latest built-in safety features you can afford.” Noting that “not all safety features are alike car-to-car,” she said choosing the right car should be individualized according to each driver’s needs. The ultimate goal: “Decrease the likelihood of a crash and cushion against serious injury should a crash occur,” she said.

With the exception of dementia or certain conditions like serious visual impairment, “the diagnosis of a medical condition should not determine whether it’s safe for someone to drive,” Mr. Nelson said. “What does matter is how you manage your condition — whether, for example, you have diabetes and keep your blood sugar under control to prevent a blackout.” Manage your health issue properly

Texas Abortion Restriction Is Temporarily Blocked

Sophia Ruiz, a patient advocate at a Whole Woman’s Health clinic in San Antonio. Whole Woman’s Health and other organizations are challenging an anti-abortion law in Texas. Credit Ilana Panich-Linsman for The New York Times

A federal judge has temporarily blocked a Texas law that would restrict the most common type of second-trimester abortion.

In a 17-page ruling on Thursday, Judge Lee Yeakel of the United States District Court for the Western District of Texas found that opponents of the law had shown “a substantial likelihood of success on the merits,” and granted a two-week restraining order while the case proceeds. The restriction had been scheduled to take effect on Friday.

The law — part of Senate Bill 8, passed this spring — would require doctors to stop the fetus’s heart before performing a dilation-and-evacuation abortion, in which the cervix is dilated and the fetus is removed in pieces. This would be done either by injecting chemicals or by cutting the umbilical cord. There would be an exception for life-threatening emergencies.

Proponents of the new law say this would ensure the “humane termination” of the fetus. Opponents say it would require women seeking abortions to undergo medically unnecessary and untested procedures — and note that using the chemicals in question would violate another Texas law, which prohibits the off-label use of drugs to induce abortions.

“The state’s interest notwithstanding, this court finds no authority for holding that government-mandated medically unnecessary, untested, or a more invasive procedure, or a more complicated and risky procedure with no proven medical benefits over the safe and commonly used banned procedure, is a permissible means of regulating previability abortions,” Judge Yeakel wrote.

The next step is a hearing on Sept. 14 on whether to grant a preliminary injunction, which could block the law from taking effect until the case is resolved. From there, the case could proceed to a full trial before the District Court or move on to the United States Court of Appeals for the Fifth Circuit. Ultimately, it could end up before the United States Supreme Court, said Janet Crepps, a senior counsel at the Center for Reproductive Rights, which is representing Texas abortion providers alongside lawyers from Planned Parenthood.

“We’re grateful that today’s decision will protect women’s access to one of the safest and most common methods of abortion in the second trimester,” Dr. Raegan McDonald-Mosley, chief medical officer at the Planned Parenthood Federation of America, said in a statement.

The Texas attorney general, Ken Paxton, criticized the ruling. Marc Rylander, a spokesman for Mr. Paxton’s office, said in a statement that dilation-and-evacuation abortions were “gruesome and inhumane, which makes it troubling that a District Court would block Texas’ lawful authority to protect the life of unborn children from such a barbaric practice.”

The statement emphasized that the law would not ban second-trimester abortions, saying it simply “ensures more humane treatment of the unborn child.”

Supporters of the law cited studies that they said demonstrated the safety of the additional procedures the law would require. However, medical officials generally oppose them. The American Congress of Obstetricians and Gynecologists has said that standard dilation-and-evacuation abortions are “evidence-based and medically preferred” in the second trimester because they cause “the fewest complications for women compared to alternative procedures.”

“We don’t really know what is the next best alternative because we haven’t had to use it as a medical community for decades,” said Dr. Bhavik Kumar, medical director of the Texas Whole Woman’s Health clinics, the main plaintiffs in the case. “There isn’t any good evidence, if any evidence, to support any of the alternatives’ being viable options.”

Before the ruling came down, Dr. Kumar said, he felt panicky thinking about having to tell patients “that this is how I normally would do the procedure if I were in any other state, but because of the new state law, I now have to provide you with care that is substandard.”

Joe Pojman, the executive director of the Texas Alliance for Life, which supports the Texas law, said in a statement that the state “should have the right to protect innocent unborn babies from dismemberment abortions, in which a doctor kills a child by tearing him or her into pieces.” The fact that courts have consistently ruled against bans on dilation-and-evacuation abortions, he argued, “shows how extremely out of touch the Supreme Court precedent is with modern science, which clearly tells us that an unborn child’’ is a living human being.

In an interview on Thursday, Dr. Daniel Grossman, a professor of obstetrics at the University of California, San Francisco, said that second-trimester abortions had increased since Texas imposed a separate set of restrictions on abortion clinics in 2013. (The Supreme Court struck those down last year.) There was a 27 percent increase in second-trimester abortions from 2013 to 2014, according to a study by Dr. Grossman and others, which might reflect women’s having trouble obtaining abortions in a timely manner. The increase in later-term abortions occurred even as the overall number of abortions in Texas declined.

“It’s particularly ironic that the state would then be imposing a ban on the safest and most commonly used procedure in the second trimester,” Dr. Grossman said, “when there’s some indication that previous restrictions they’ve imposed are pushing women to need this procedure more.”

F.D.A. Approves First Gene-Altering Leukemia Treatment, Costing $475,000

F.D.A. Approves First Gene-Altering Leukemia Treatment, Costing $475,000

The Food and Drug Administration on Wednesday approved the first-ever treatment that genetically alters a patient’s own cells to fight cancer, a milestone that is expected to transform treatment in the coming years.

The new therapy turns a patient’s cells into a “living drug,” and trains them to recognize and attack the disease. It is part of the rapidly growing field of immunotherapy that bolsters the immune system through drugs and other therapies and has, in some cases, led to long remissions and possibly even cures.

The therapy, marketed as Kymriah and made by Novartis, was approved for children and young adults for an aggressive type of leukemia — B-cell acute lymphoblastic leukemia — that has resisted standard treatment or relapsed. The F.D.A. called the disease “devastating and deadly” and said the new treatment fills an “unmet need.”

Novartis and other companies have been racing to develop gene therapies for other types of cancers, and experts expect more approvals in the near future. Dr. Scott Gottlieb, the F.D.A. commissioner, said that more than 550 types of experimental gene therapy were being studied.

There are drawbacks to the approach. Because Kymriah can have life-threatening side effects, including dangerous drops in blood pressure, the F.D.A. is requiring that hospitals and doctors be specially trained and certified to administer it, and that they stock a certain drug needed to quell severe reactions.

Kymriah, which will be given to patients just once and must be made individually for each, will cost $475,000. Novartis said that if a patient does not respond within the first month after treatment, there will be no charge. The company also said it would provide financial help to families who were uninsured or underinsured.

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Emily Whitehead, shown here in May, was near death at age 6 from leukemia and became the first pediatric patient to receive the experimental gene therapy. She is now 12 and has been in remission for more than five years. Credit Children’s Hospital of Philadelphia, via Associated Press

Discussing the high price during a telephone news conference, a Novartis official noted that bone-marrow transplants, which can cure some cases of leukemia, cost even more, from $540,000 to $800,000.

About 600 children and young adults a year in the United States would be candidates for the new treatment.

The approval was based largely on a trial in 63 severely ill children and young adults who had a remission rate of 83 percent within three months — a high rate, given that relapsed or treatment-resistant disease is often quickly fatal.

The treatment was originally developed by researchers at the University of Pennsylvania and licensed to Novartis. It was identified in previous reports as CAR-T cell therapy, CTL019 or tisagenlecleucel.

The first child to receive the therapy was Emily Whitehead, who was 6 and near death from leukemia in 2012 when she was treated, at the Children’s Hospital of Philadelphia. Now 12, she has been free of leukemia for more than five years.

To customize Kymriah for individual patients, white blood cells called T cells will be removed from a patient’s bloodstream at an approved medical center, frozen, shipped to Novartis in Morris Plains, N.J., for genetic engineering and multiplying, frozen again and shipped back to the medical center to be dripped into the patient. That processing is expected to take 22 days.

Novartis said the treatment would be available at an initial network of 20 approved medical centers to be certified within a month, a number that would be expanded to 32 by the end of the year. Five centers will be ready to start extracting T cells from patients within three to five days, the company said.

An intravenous bag of Kymriah, which must be customized for individual patients. It is expected to cost $475,000 and can have potentially fatal side effects. Credit Novartis, via Associated Press

Certification is being required because the revved-up T cells can touch off an intense reaction, sometimes called a cytokine storm, that can cause high fever, low blood pressure, lung congestion, neurological problems and other life-threatening complications. Medical staff members need training to manage these reactions, and hospitals are being told that before giving Kymriah to patients, they must be sure that they have the drug needed to treat the problems, tocilizumab, also called Actemra.

Dr. Kevin J. Curran, a pediatric oncologist at Memorial Sloan Kettering Cancer Center in Manhattan, said his hospital was “99 percent” of the way through the certification process, and would soon be offering Kymriah.

“This is a big paradigm shift, using this living drug,” Dr. Curran said. “It will provide a lot of hope. This is the beginning.”

He said he expected that eventually this type of treatment would work for other, more common types of cancer, not just for leukemia.

The F.D.A.’s approval of Kymriah ushers in “a new approach to the treatment of cancer and other serious and life-threatening diseases,” the agency said in a statement, noting that the new therapy is “the first gene therapy available in the United States.”

Dr. Carl June, a leader in developing the treatment at the University of Pennsylvania, recalled that in 2010, when tests showed that the first patient was leukemia-free a month after being treated, he and his colleagues did not believe it. They ordered another biopsy to be sure.

“Now, I have to keep pinching myself to see that this happened,” Dr. June said, his voice breaking with emotion. “It was so improbable that this would ever be a commercially approved therapy, and now it’s the first gene therapy approved in the United States. It’s so different from all the pharmaceutical models. I think the cancer world is forever changed.”

 

New Fathers Are Older Than Ever

A young family in California in 1936. Researchers at Stanford University found that the average age of the father of a newborn in the United States has risen to 30.9. Credit Dorothea Lange, via Library of Congress

New fathers in the United States are getting older.

Researchers at Stanford University reviewed data on 168,867,480 live births from 1972 to 2015, making statistical adjustments for missing paternal records. The average age of the father of a newborn in the United States, the investigators found, has risen to 30.9 from 27.4 in 1972.

Paternal age increased across the country: the oldest fathers lived in the Northeast, and the youngest in the South. There were average age increases across all educational levels, races and ethnicities. The report appears in the journal Human Reproduction.

In 2015, fathers with college degrees were 33.3 years old on average, compared with 29.2 for those with only a high school diploma. Asian fathers were the oldest on average by ethnicity, and blacks and Hispanics the youngest.

Japanese fathers saw the largest increase in average age during the study period, from 30.7 in 1972 to 36.3 in 2015. White fathers were on average 27.6 years old in 1972 and 31.1 in 2015, while the average age of black fathers increased to 30.4 from 27.2.

Over the study period, the percentage of fathers older than 40 increased to 8.9 percent from 4.1 percent of all annual births, the percentage over 45 to 2.9 percent from 1.5 percent, and the percentage over 50 to 0.9 percent from 0.5 percent.

The trend is not exclusive to the United States. In Germany, for example, the median age of fathers rose during the 1990s to 33.1 from 31.3. In England, fathers over 35 accounted for 40 percent of all births in 2003, compared with 25 percent in 1993.

“One thing that did surprise me is that the difference between mothers’ and fathers’ ages has been decreasing,” said Dr. Michael L. Eisenberg, the lead author of the report and director of male reproductive medicine and surgery at Stanford.

“The father is still older than the mother, but the gap is narrowing.”

Older paternal age has been associated with higher rates of miscarriage, birth defects, some cancers, schizophrenia and autism. Some experts have suggested that older sperm is more likely to have mutations that lead to disease.

But a study last year in Nature Genetics concluded that such mutations are probably a small part of the cause. Instead, men who are genetically predisposed to psychiatric and other illnesses are also more likely to delay fatherhood, and those genetic tendencies are inherited by their children. The question remains unsettled.

A little more than 10 percent of birth certificates don’t include paternal data, a problem that needs fixing, Dr. Eisenberg said. “Fertility is a team sport. It’s a disservice to ignore one half of the equation.”