Saturday, August 13, 2011

Health - Cholera Outbreaks Spread Across Somalia, U.N. Says

Health - Cholera Outbreaks Spread Across Somalia, U.N. Says

Cholera Outbreaks Spread Across Somalia, U.N. Says

Posted: 12 Aug 2011 10:00 PM PDT

NAIROBI, Kenya — A cholera epidemic is sweeping across Somalia, the United Nations said on Friday, as thousands of starving people flee famine zones and pack into crowded camps in the capital, Mogadishu.

Multimedia
Photographs
Famine in Somalia

Related

According to the United Nations World Health Organization, 181 people have died from suspected cholera cases in a single hospital in Mogadishu, and there have been several other confirmed cholera outbreaks across the country.

“We don’t see the end of it,” said Tarik Jasarevic, a spokesman for the World Health Organization. “As long as we have people on the move, in crowded places and using contaminated water, we will see a rise in cases. All the causes are still there.”

Parts of southern Somalia are in the grip of a famine, the result of years of conflict and one of the worst droughts in 60 years. Compounding the problem are the limitations of the transitional government of Somalia, which controls little more than the capital — and it is a loose control at that — and much of the country is in the hands of a group of Islamist militants, the Shabab, who have forced out many Western aid organizations.

United Nations agencies and private aid groups are struggling to respond to the needs, and though some progress has been made in recent weeks, many Shabab areas are essentially off-limits. More than 100,000 people have recently fled famine areas and settled in makeshift camps in Mogadishu, which have become breeding grounds for measles, cholera and other diseases.

Cholera is spread through dirty water. It is easily treated with oral rehydration salts and antibiotics. But many health centers in Somalia lack even these basic supplies.

The American government estimates that at least 29,000 Somali children have died so far from the famine, and many more are expected to die unless enough emergency food and trained medical personnel can reach the famine areas soon.

Shortcuts: Family Happiness and the Overbooked Child

Posted: 12 Aug 2011 09:40 PM PDT

I LIVE in an area where most parents would rather cut back on indulgences for themselves than stop paying for their children’s activities.

Enlarge This Image
Pat Gallagher/The Valdosta Daily Times, via Associated Press

Learning to play a musical instrument may bring a child lifelong joy, but don't count on it to reveal hidden genius.

Music lessons, gymnastics, horseback riding, tutoring, summer-long residential camps, sports teams — the list goes on and on. Often, so do the costs.

And even if the money is not there, some parents find a way. I know people who have borrowed from family, used home equity accounts and run up their credit cards to pay for all the stuff they believe their children just cannot miss.

“The experiences we thought kids had to have before high school has moved down to junior high and now elementary,” said William Doherty, a professor of family studies and director of the marriage and family therapy program at the University of Minnesota. “Soon, we’ll be talking about leadership opportunities for toddlers.”

To come clean, my children through the years have taken ice skating, tennis, violin and yes, even tae kwon do (of which the only residue now seems to be lots of colored belts around the house). Some lessons lasted a few months, some for years.

And what is wrong with that? Maybe we know that some parents go overboard on extracurricular activities, but aren’t these important for their children’s future success?

Somehow, not offering our children every possible opportunity “feels like bad parenting,” said Wendy Mogel, a clinical psychologist and author of “The Blessing of a B Minus,” (Scribner, 2010).

But in an effort to give their children everything, some parents end up not just depleting financial resources, but also their own emotional energy.

“A lot of parents are exhausted by their own overparenting,” said Bryan Caplan, an economics professor at George Mason University. “They make so many sacrifices and are so stressed out by driving around so much that they explode at kids for changing the radio station.”

But isn’t it worth it for the ultimate good of our children? Not necessarily. Some of the most interesting insights into this question come not from psychologists, but economists.

“It’s easy to take a look at the more successful kids and assume that all the activities are why they are more successful,” Professor Caplan said. But research doesn’t bear that out.

On a recent National Public Radio program, Steven D. Levitt, a professor of economics at the University of Chicago, said he and another economist could find no evidence that that sort of parental choices could be correlated at all with academic success.

“And my guess is,” he went on, “that when it comes to the happiness of kids, that kind of cramming has got to be negatively correlated. Being rushed from one event to the other is just not the way most kids want to live their lives, at least not my kid.” Professor Levitt was also co-author of the New York Times blog Freakonomics.

All right, the economists are largely talking about academic success. But I would wager that most parents believe these experiences are not just for good grades, or are the key to the right college, but are also for the opportunities they give children.

Most parents know that an infinitesimal number of children will go on to be world class in any field. But maybe those pricey golf lessons will earn your son a place on the high school team. Or the acting classes will propel your daughter into the lead in the school play.

And what parent doesn’t dream that piano lessons will instill a lifelong love of playing, even if it is only in the living room?

The trouble is, many of us have bought into the idea that every child has a “hidden talent,” Professor Doherty said, and that we are failing our children if we don’t do everything possible to bring it to light.

There are certainly good reasons to offer our children some of these experiences, but there are more negative ones as well, if we rely on them to make us feel like good parents, or if we think that arming them with a myriad of skills can guarantee their later success in life.

The desire to offer every conceivable opportunity is a “displaced fear about the collapse of the future,” Dr. Mogel said.

The reality is that failing to give your child ballet lessons at age 6 probably has not deprived her of a career as a prima ballerina.

And even if a child is passionate about something, that doesn’t mean you have to go all out, “if it’s to the detriment of the parent’s sanity or a connected family life,” Professor Doherty said.

Or to one’s finances.

E-mail: shortcuts@nytimes.com

Recipes for Health: Greek Salad Sandwich

Posted: 12 Aug 2011 01:39 PM PDT

Greek salad on a bun makes a wonderfully satisfying meal. The English muffins absorb the sweet and tangy juices from the salad without becoming soggy.

Recipes for Health

Martha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.

Related

2 tomatoes, ripe but firm, 1 thinly sliced, 1 cut in small dice

2 ounces cucumber, thinly sliced

2 ounces green pepper (about 1/2 small pepper), seeded and thinly sliced

1 slice red onion, cut in half, rings separated, rinsed and drained (optional)

1 tablespoon crumbled feta (about 1/2 ounce)

1 to 2 teaspoons chopped fresh mint

1 teaspoon sherry vinegar or red wine vinegar

2 teaspoons extra virgin olive oil

Salt and freshly ground pepper (optional)

2 small (3 1/2-inch) whole-wheat English muffins, lightly toasted

2 teaspoons mayonnaise

Dijon mustard (optional)

1. In a medium bowl, combine the diced tomato, cucumber, green pepper, onion, feta and mint. Toss with the vinegar and olive oil. Season if desired with salt and pepper.

2. Spread the bottom half of an English muffin with half the mayonnaise. Layer half of the sliced tomato on top. Top with half the Greek salad mixture. Spread the top half of an English muffin with mustard if desired, and place on top of the salad. Press down, cut in half and serve. Alternately, you may wrap the sandwich in plastic and refrigerate. Use the remaining ingredients for a second sandwich.

Yield: Two sandwiches.

Advance preparation: The sandwiches will keep well for a day. Wrap tightly in plastic wrap, and place in a bag. Keep cold if possible.

Nutritional information per serving: 258 calories; 2 grams saturated fat; 1 gram polyunsaturated fat; 4 grams monounsaturated fat; 8 milligrams cholesterol; 34 grams carbohydrates; 7 grams dietary fiber; 352 milligrams sodium (does not include salt to taste); 8 grams protein

Martha Rose Shulman is the author of "The Very Best of Recipes for Health."

Hot Chemotherapy Bath: Patients See Hope, Critics Hold Doubts

Posted: 12 Aug 2011 01:17 PM PDT

SAN DIEGO — This is cancer therapy at its most aggressive, a treatment patients liken to being filleted, disemboweled and then bathed in hot poison.

Multimedia
Slide Show
A Controversial Cancer Treatment, Step by Step

Related

The therapy, which couples extensive abdominal surgery with blasts of heated chemotherapy to the abdominal cavity and its organs, was once a niche procedure used mainly against rare cancers of the appendix. Most academic medical centers shunned it.

More recently, as competition for patients and treatments intensifies, an increasing number of the nation’s leading medical centers has been offering the costly — and controversial — therapy to patients with the more common colorectal or ovarian cancers. And some hospitals are even publicizing the treatment as a hot “chemo bath.”

To critics, the therapy is merely the latest example of one that catches on with little evidence that it really works. “We’re practicing this technique that has almost no basis in science,” said Dr. David P. Ryan, clinical director of the Massachusetts General Hospital Cancer Center.

But to some patients, the procedure, however grueling and invasive, represents their best hope for survival: “It’s throwing everything but the kitchen sink at cancer,” said Gloria Borges, a 29-year-old Los Angeles lawyer who had her colon cancer treated with what she called the “pick it out, pour it in” procedure.

For hours on a recent morning at the University of California, San Diego, Dr. Andrew Lowy painstakingly performed the therapy on a patient.

After slicing the man’s belly wide open, he thrust his gloved hands deep inside, and examined various organs, looking for tumors. He then lifted the small intestine out of the body to sift it through his fingers.

As he found tumors, he snipped them out. “You can see how this is coming off like wallpaper,” Dr. Lowy said as he stripped out part of the lining of the man’s abdominal cavity.

After about two hours of poking and cutting, Dr. Lowy began the so-called shake and bake. The machine pumped heated chemotherapy directly into the abdominal cavity for 90 minutes while nurses gently jiggled the man’s bloated belly to disperse the drug to every nook and cranny.

The treatment is formally called cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy, or Hipec.

Recent converts include University Hospitals Case Medical Center in Cleveland, Montefiore Medical Center in the Bronx, and even Massachusetts General. The Memorial Sloan-Kettering Cancer Center is looking at it, according to people in the field. Advocates predict that the number of procedures could grow to 10,000 a year from about 1,500 now.

The therapy has even been featured on an episode of the TV series “Grey’s Anatomy.”

But Dr. Ryan, a gastrointestinal oncologist, suggested in an interview that the procedure was being extended to colorectal cancer because “you can’t make a living doing this procedure in appendix cancer patients.”

He debated the procedure publicly at the recent annual meeting of the American Society of Clinical Oncology. While some patients did seem to live much longer than expected, he said that they had been carefully selected and might have fared well even without the therapy.

Proponents say that if cancer has spread into the abdominal cavity but not elsewhere, then lives can be prolonged by removing all the visible tumor and killing what’s missed with Hipec.

By contrast, said Dr. Paul Sugarbaker, a surgeon at Washington Hospital Center and the leading proponent of Hipec, “there are no long-term survivors with systemic chemotherapy — zero.”

Dr. Sugarbaker, who opposed Dr. Ryan in the debate, said that it has long been known that cancerous cells are unable to withstand as much heat as healthy cells. And putting the chemotherapy on top of tumors should be more effective than systematically delivering it through the bloodstream.

One randomized trial done more than a decade ago involving 105 patients in the Netherlands did show a striking benefit. The median survival of those getting surgery and Hipec, plus intravenous chemotherapy, was 22.3 months, almost double the 12.6 months for those getting only the intravenous chemotherapy. But 8 percent who got the surgery and Hipec died from the treatment itself. And critics say that since that trial was conducted, new drugs have come to market that allow patients with metastatic colorectal cancer to live two years with intravenous chemotherapy alone.

A new trial in the United States has been temporarily suspended so that researchers can find a way to recruit patients. After nearly a year only one patient had enrolled, because people were reluctant to chance winding up in the control group, according to one of the investigators.

While proponents contend that the risk of dying from the surgery has been reduced since the Dutch trial, the procedure still lasts eight hours or more and full recovery can take three to six months. “It’s maximally invasive,” said Dr. Sugarbaker, who often removes the “spare parts” — organs a patient can live without, like the spleen, the gall bladder, the ovaries and the uterus.

The New Old Age Blog: Do Hospitalists Save Money?

Posted: 12 Aug 2011 08:46 AM PDT

Chimp’s Victim Gets a New Face

Posted: 11 Aug 2011 10:20 PM PDT

Enlarge This Image
Reuters

Charla Nash, before she was attacked by a 200-pound chimpanzee two years ago, and right, after her most recent surgery.

Metro Twitter Logo.

Connect With Us on Twitter

Follow @NYTMetro for New York breaking news and headlines.

HARTFORD (AP) — The new face of a Connecticut woman who was mauled by a chimpanzee two years ago was revealed for the first time on Thursday, in video and photographs that showed a startling transformation.

The video of the woman, Charla Nash, was broadcast on the “Today” show on NBC; the photographs appeared in Hearst Connecticut Newspapers.

Ms. Nash, 57, had a face transplant in May at Brigham and Women’s Hospital in Boston. She did not appear in person on “Today” because, family members said, she was too weak for an interview. The video was recorded in the hospital; in it, she indicated that she was able to smile and smell. She is also able to eat.

Ms. Nash was attacked in Stamford, Conn., in February 2009 by a friend’s 200-pound chimpanzee; it ripped off her nose, lips, eyelids and hands. The attack left her blind.

The Texas Tribune: Delight and Unease Over Law on Student Vaccinations

Posted: 11 Aug 2011 09:00 PM PDT

Among the things 22-year old Jamie Schanbaum could not have anticipated three years ago was standing two inches taller, winning a national Paralympic gold medal in cycling and reveling in the Texas Legislature’s passage of two bills in her honor. Those gains, however, came after significant losses — most noticeably of both legs below the knee and much of each finger, the result of a bout with meningococcal septicemia in her sophomore year at the University of Texas.

Enlarge This Image
Callie Richmond for The Texas Tribune

Jamie Schanbaum, a victim of bacterial meningitis, has had two vaccine-related laws named for her.

The Texas Tribune

Expanded coverage of Texas is produced by The Texas Tribune, a nonprofit news organization. To join the conversation about this article, go to texastribune.org.

Commonly known as bacterial meningitis, meningococcal disease is a potentially fatal bacterial infection that saddles about one-fifth of its survivors with lifelong effects. Texas had 336 cases in 2009, according to the Department of State Health Services, 34 of them in people ages 15 to 29.

Ms. Schanbaum underwent numerous operations during months in the hospital, where the onset of a flesh-eating bacteria ultimately necessitated the amputations.

“It could have been worse,” Ms. Schanbaum said. “I could have been blind. I could have been deaf. I could have had brain damage. I could have died. I wouldn’t say I feel unlucky at all. I would say I consider this significant.”

So does Texas, which — after Gov. Rick Perry signed the second bill named for Ms. Schanbaum into law in May — became the first state to require every college student to be vaccinated against bacterial meningitis. (The Jamie Schanbaum Act of 2009 already required students living in campus dorms to be vaccinated.)

The new law, which will take effect at the start of 2012, expands that provision to apply to any new student under 30 taking on-campus classes even if they live off campus. While the tweak sounds deceptively simple, it has colleges and universities scrambling to raise awareness of such a broad policy and to figure out how to put it into effect.

Some critics, like Representative David Simpson, Republican of Longview, argue that the new laws amount to government intrusion, though students can opt out for medical or religious reasons.

The most recent bill, introduced in the Senate by Wendy Davis, Democrat of Fort Worth, was also named for Nicolis Williams, a Texas A&M University student who died in February after contracting bacterial meningitis. Mr. Williams, 20, lived off campus.

“I think it brings meaning to Nicolis’s death,” Ms. Davis said of her bill. “From this day forward, we’ll never know, of course, whose life was saved as a consequence, but no doubt there will be people whose lives are saved.”

Nevertheless, Mr. Simpson and 17 other House members opposed the bill. “I’m for freedom,” he said. “I’m not for the government dictating to us what we must do with our bodies.”

Mr. Simpson said it was comparable to what he considers invasive actions by federal airport security officers, which he has publicly challenged, and to a proposed ban on texting while driving that Mr. Perry vetoed — in Mr. Simpson’s view, correctly — for allowing government too much say in the personal lives of drivers.

Mr. Simpson also noted with particular frustration a February ruling in which the Supreme Court ruled that vaccine makers are protected from lawsuits by parents who believe shots harmed their children.

Mr. Williams’s father, Greg, an administrator at Texas Southern University who championed the bill, said, “I knew at the time of his death that there was probably a bigger plan in place in than I even thought of, because too many things happened that, in my mind, were more than a coincidence.”

Among those things was an empathetic state representative, Charlie F. Howard, Republican of Sugar Land, who had also lost a son. Mr. Howard sponsored the bill in the House.

Most important, the Advisory Committee on Immunization Practices at the federal Centers for Disease Control and Prevention had just updated its recommendations for the bacterial meningitis vaccine to include all college students. The update came after it was found that the vaccination given to preteenagers was wearing off, leaving all young adults ages 17 to 21 vulnerable, not just those living in crowded dorms.

rhamilton@texastribune.org

Well: Letting Doctors Make the Tough Decisions

Posted: 11 Aug 2011 09:49 AM PDT

App Smart: Curl Up With a Soothing Smartphone and Relax

Posted: 10 Aug 2011 10:00 PM PDT

Unless you’re listening to “Dark Side of the Moon” on your smartphone, it’s hard to see them as devices for relaxation. More often, they’re for aggressive thumb-tapping, Angry-Birding exercises.

Enlarge This Image

"Simply Being," available for Apple, Android and BlackBerry, offers guided meditation of various lengths.

Enlarge This Image

Mindfulness Meditation is written and narrated by Stephan Bodian, the author of “Meditation for Dummies.”

But for every yin there is a yang. And mobile phones are no exception.

A path to a quiet mind can travel through apps dedicated to guided meditation and sleep enhancement. And fortunately, for those who need more, or better, rest, or who are inclined to still their minds for a few minutes a day, some good ones exist on all the major mobile platforms.

Simply Being ($1 on Apple, Android and BlackBerry) and Mindfulness Meditation ($2 on Apple, with an Android version in the works) are among the better ones, while Universal Breathing - Pranayama Free (free on Apple) and Pranayama Free (on Android) are useful for those who want to test the waters.

Those with pressing insomnia issues should consider Pzizz Sleep ($6 on Apple, with a Lite version for $2). On Android, the app costs $5.69 and goes by the name Pzizz, the Insomnia Solution. Another good, but pricey, option, is Mayo Clinic Insomnia Wellness Solutions ($25 on Apple).The meditation apps, though, may well be enough to get you to sleep — or at least help calm you down.

Pranayama Free is the simplest. It leads you through exercises meant to limit you to seven breaths per minute, five breaths per minute, or about four breaths per minute. When I tried it, the graphics were helpful, but the music was a tad obtrusive.

A bigger problem was that it was slow to load and not very responsive to the touch (at least on my Droid2), so it was barely more relaxing than frustrating.

I tried Simply Being not long after in the middle of a workday that had gone haywire. I was surrounded by e-mail-toting gadgets that, I was sure, were loading important messages from colleagues.

I grabbed my iPhone and opened Simply Being, and the screen offered four options for “guided meditation for relaxation and presence.” I chose the 5-minute option, and left the 10-, 15- and 20-minute options for another day.

I then chose music, rather than nature sounds, to accompany the narrative, and I tweaked the volume of each so the narrative was clearly audible.

I was braced for a narrator who had the sort of whispery, saccharine tone that’s as relaxing as a Sawzall on a steel pipe, but fortunately, the narrator, Mary Maddux, used an approach that didn’t sound like a parent cooing a baby to sleep.

Ms. Maddux’s husband and co-developer of the app, Richard Maddux, composed the admirable soundtrack.

After five minutes I was nearly asleep.

Not everyone will respond to a given narrator’s voice, so another good choice is Mindfulness Meditation, which is written and narrated by Stephan Bodian, the author of “Meditation for Dummies.”

Mr. Bodian’s narrative was thorough, relaxing and well pitched for a meditation novice like me. There is no music or sound accompaniment, but there is more content to the app than in Simply Being.

Users can choose meditations of 5, 10, 15, 20 and 30 minutes, or a simpler relaxation narrative of 10 minutes.

A guide also offers audio tips for finding the best meditation position, for instance, and there is a text-based checklist of eight factors to improve the experience.

About an hour after nearly falling asleep to Ms. Maddux’s voice, I did the same with Mr. Bodian’s voice.

That drowsiness was partly due to a bout of insomnia the previous night. Lying awake at 3 a.m., I tried Brain Wave ($2 on Apple), which features binaural electronic tones against the backdrop of nature sounds. According to the app’s description, it requires earbuds or earphones to work properly.

Brain Wave, which has attracted good ratings from iTunes users, also has programs for easing anxiety, improving mental focus and the like, but I chose the option “Deep Sleep.” It wasn’t very practical because I couldn’t lay my head to either side or the earbuds would jam into my ear.

Either because of that, or because the binaural sounds simply didn’t work for me, I felt no closer to sleep after 45 minutes. I turned off the program, pulled out the earbuds and later managed to get to sleep.

Another option is Pzizz Sleep, which uses binaural sounds, spoken words and music in new combinations each time the user opens the app. It’s a smart choice for those who tend to grow weary of repeated narrations on other apps.

The Mayo clinic app is generally good, as well. Given how much money insomniacs spend on other treatment options, it is arguably worth the $25 investment.

That’s especially true for iPad users. The app is split between a multipage stress assessment and roughly 90 minutes of videos, and the videos, especially, render nicely on the iPad’s screen. (Free tip: It’s a myth that exercising before bedtime will help you fall asleep more easily.)

For the price, though, users should be able to expect an experience that is devoid of fluff. Although many of the video tutorials are useful, including an in-depth discussion of insomnia by Mayo Clinic specialists, far too much video is devoted to a promotion of the app’s developer and the Mayo Clinic.

It’s anyone’s guess, for instance, why insomniacs would need to watch a testimonial from a mother whose son was diagnosed with a rare form of cancer at the Mayo Clinic.

It’s enough to make you mad — that is, if you weren’t already in full command of your emotions.

Quick Calls

Lose It!, a popular (and free) weight-loss app for Apple, is now available on Android. ... An Android version of Poetry, a great (free) app on Apple, for lovers of verse, also recently had its debut. ... Shnap (free on Apple) is a cool new photo filtering and sharing tool. Earn points by posting popular pictures of your own and rating photos of others.

Test Can Tell Fetal Sex at 7 Weeks, Study Says

Posted: 10 Aug 2011 08:42 AM PDT

A simple blood test that can determine a baby’s sex as early as seven weeks into pregnancy is highly accurate if used correctly, a finding that experts say is likely to lead to more widespread use by parents concerned about gender-linked diseases, those who are merely curious and people considering the more ethically controversial step of selecting the sex of their children.

Enlarge This Image
Michael Stravato for The New York Times

Raylene Lewis, 34, with her daughter Rilynn, 5, who a test from a now-defunct company indicated was going to be a boy.

Well

Share your thoughts on this column at the Well blog.

Go to Well »

The appeal of the test, which analyzes fetal DNA found in the mother’s blood, is that it can establish sex weeks earlier than other options, like ultrasound, and is noninvasive, unlike amniocentesis and other procedures that carry small risks of miscarriage. The finding came in a study published online Tuesday in The Journal of the American Medical Association.

The tests have been available to consumers in drugstore chains and online for a few years, but their use has been limited, partly because their accuracy was unclear. One company, which guaranteed 99.9 percent accuracy as early as five weeks into pregnancy, filed for bankruptcy after a lawsuit by scores of women whose tests showed the opposite sex of the baby they ended up having.

European doctors now routinely use the tests to help expectant parents whose offspring are at risk for rare gender-linked disorders determine whether they need invasive and costly genetic testing. For example, Duchenne muscular dystrophy affects boys, but if the fetus is not the at-risk sex, such tests are unnecessary. But doctors in the United States generally have not prescribed the tests because they are unregulated and medical labs are not yet federally certified to use them.

That and other aspects of the pregnancy landscape could change as a result of the new study. The journal study analyzed reams of research on fetal DNA tests — 57 studies involving about 6,500 pregnancies — and found that carefully conducted tests could determine sex with accuracy of 95 percent at 7 weeks to 99 percent at 20 weeks.

The study “has wide-reaching implications,” said Dr. Louise Wilkins-Haug, director for maternal-fetal medicine and reproductive genetics at Brigham and Women’s Hospital in Boston, who was not involved in the research. “Individuals need to be careful” to ensure that companies use rigorous laboratory procedures and support accuracy claims with data, she added.

One potential worry is that women might abort fetuses of an undesired sex. Several companies do not sell tests in China or India, where boys are prized over girls and fetuses found to be female have been aborted. While sex selection is not considered a widespread objective in the United States, companies say that occasionally customers expressed that interest, and have been denied the test. A recent study of third pregnancies in the journal Prenatal Diagnosis found that in some Asian-American groups, more boys than girls are born in ratios that are “strongly suggesting prenatal sex selection,” the authors said.

At least one company, Consumer Genetics, which sells the Pink or Blue test, requires customers to sign a waiver saying they are not using the test for that purpose. “We don’t want this technology to be used as a method of gender selection,” said the company’s executive vice president, Terry Carmichael. Sex-determination tests are part of a new frontier of fetal DNA testing, which can be used to determine paternity and blood type, and is being used to develop early screening tests for genetic diseases like Down syndrome.

The new study found that to be reliable, the sex-determination tests had to be performed after at least seven weeks of gestation. Most tests that were highly accurate were conducted on a mother’s blood, not urine. And certain rigorous laboratory procedures had to be followed. For the blood tests, women prick their fingers and send blood samples to labs. If the Y chromosome is detected, the fetus is male. Absence of a Y chromosome would probably mean the fetus is female, but could mean that fetal DNA was not found in that sample.

The tests are not regulated by the Food and Drug Administration because they are not used for medical purposes, a spokeswoman said, but the agency is investigating the explosion of home genetic tests like these and genome-sequencing kits.

Dr. Diana Bianchi, executive director of the Mother Infant Research Institute at Tufts Medical Center in Boston and the lead author of the sex-determination report, said, “A very important aspect of the study is how this advances prenatal care.”

But there are potential concerns too, she said, including that women may spend more than $250 for the tests when they don’t have insurance for prenatal care. A typical blood test like Pink or Blue, for example, costs $25 for the kit. Lab fees and shipping costs, which vary, bring the total expense to $265 to $330.

Dr. Bianchi is conducting another study to “try to find out why people are buying these things and what are the consequences,” she said. “It’s very important to educate health care providers that pregnant women are buying these tests.”

Another type of test not studied by the researchers has become popular because it is cheaper and can be done at home. These tests analyze hormones in women’s urine, a method that several experts said has not been studied as rigorously as DNA. Rebecca Griffin, a founder of the biggest seller, Intelligender, said two independent studies found it 90 percent accurate at 10 weeks.

Another company, TrovaGene, has developed a DNA test using urine, which, according to Gabriele Cerrone, TrovaGene’s co-founder and director, is 95 percent accurate at predicting boys at seven weeks, and 88 percent accurate at predicting girls. TrovaGene is also developing a test for Down syndrome.

Most DNA tests on the market use blood.

Raylene Lewis, 34, of College Station, Tex., had a frustrating experience with a now-defunct company, Acu-Gen, which guaranteed 99.9 percent accuracy with its blood tests. In 2005, she was told she was having a boy, and she chose a name, bought boy clothes and told everyone. When an ultrasound revealed she was carrying a girl, “I was absolutely shocked,“ she said. She was not unhappy, she said, but “it was like the baby boy disappeared.”

When the Lewises complained to Acu-Gen’s president, they were told, “We are very sure that genetically you are having a male,” she said, reading a transcript of the conversation, which they recorded. The official suggested that the baby might be “what a baby girl looks like on the outside,” but that “we’re giving you the results on the inside.”

Ms. Lewis, who sued Acu-Gen, said she ultimately received a refund. Lawyers for Acu-Gen could not be reached for comment.

The Pink or Blue test, which claims 95 percent accuracy at seven weeks and gives refunds for wrong results, appears to meet the standards described in the new study.

Chelsea Wallace, 23, of Okeechobee, Fla., was thrilled early this year when the test she took at seven weeks said she was having a boy, a result confirmed weeks later by ultrasound. Ms. Wallace, who has a 3-year-old daughter, said she also would have been happy with a girl, but that since she and her fiancé could not agree on a boy’s name, finding out early gave them time to choose the name Layton. It also helped her plan, she said.

“As soon as I found out I was pregnant,” said Ms. Wallace, whose son is due in September, “I wanted to know what I was having.”

This posting includes an audio/video/photo media file: Download Now

Johnson & Johnson to Settle Charge Over Drug’s Marketing

Posted: 10 Aug 2011 01:02 AM PDT

Johnson & Johnson reached an agreement in principle to settle a misdemeanor criminal charge related to the marketing of its antipsychotic drug Risperdal, the company said in a regulatory filing on Tuesday.

Prosecutors have been investigating the company’s Risperdal sales practices since 2004, including accusations that it marketed the drug for unapproved uses, Johnson & Johnson said in its quarterly filing.

“Discussions have been ongoing in an effort to resolve criminal penalties under the Food, Drug and Cosmetic Act related to the promotion of Risperdal,” Johnson & Johnson said. “Certain issues remain open before a settlement can be finalized.”

The agreement in principle on the criminal charge is on a single misdemeanor violation of the Food, Drug and Cosmetic Act, the company said.

The Justice Department and the United States attorney in Philadelphia “are continuing to pursue both criminal and civil actions,” the company said.

Johnson & Johnson said it had adjusted the accrued amount in the second quarter of 2011 to cover the financial component of the proposed criminal settlement, but did not disclose an amount for the reserve.

The company said it was also in negotiations to settle civil investigations related to the marketing of Risperdal and another drug, Invega. It said it was not sure a settlement could be reached on those claims.

10 Years and a Diagnosis Later, 9/11 Demons Haunt Thousands

Posted: 10 Aug 2011 09:29 AM PDT

In the safety of her therapist’s office in late 2001, Dr. Margaret Dessau made a tape reliving what it was like to look out her living room window after she heard the boom of a hijacked plane eight blocks away.

Related

Enlarge This Image
Raymond McCrea Jones/The New York Times

Earl Holland is one of at least 10,000 survivors of 9/11 with post-traumatic stress disorder.

Running naked from her bath, she saw pigeons and paper flying through the air. “It’s kind of beautiful in a way,” she recalls on the recording she made and listened to over and over as part of her treatment. “There’s these silver pieces just floating in the air.”

Her gaze met the hole in the tower. “The flames get worse, and then I start seeing all these people hanging out there. The guy with this white towel, and he’s waving it.”

He jumps. Children at a nearby school scream.

“How are you feeling?” her therapist, David Bricker, is heard asking on the tape.

“I start crying,” she replies.

Dr. Dessau’s husband yells at her, “Stop looking at it, stop looking at it.” But, she says, “I can’t tear myself away from it.”

One measure of the psychological impact of 9/11 is this: At least 10,000 firefighters, police officers and civilians exposed to the terrorist attack on the World Trade Center have been found to have post-traumatic stress disorder, and in a kind of mass grieving, many of them have yet to recover, according to figures compiled by New York City’s three 9/11 health programs.

In interviews over the last several months, Dr. Dessau and others revealed a wide-ranging but consistent body of symptoms. They cannot sleep. They replay the disaster in their minds, or in their nightmares. They have trouble concentrating. They are jittery and overreact to alarms or loud noises. They feel helpless, hopeless, guilty and cut off from the people who are close to them. They avoid anything that reminds them of that terrible day.

Millions of dollars will be spent treating them over the next few years through the James Zadroga 9/11 Health and Compensation Act, passed by Congress in December, which provides $4.3 billion to compensate and treat people with 9/11-related illnesses.

Some are emergency responders and others who vainly searched the debris for survivors. But some were residents, commuters and office workers caught in the dust cloud. And others were passive witnesses with no direct connection to the attack other than proximity.

Because of lingering questions about the bounds of the PTSD diagnosis, which is only three decades old, people with mental problems are eligible only for treatment assistance, whereas people with physical ailments, in most cases breathing difficulties, qualify for both treatment and compensation. And money available to treat patients with the stress disorder might decline if the government concludes there is a link between certain cancers and 9/11, which would give cancer patients access to the same pool of money. Doctors are expecting a surge in PTSD patients with the coming 10th anniversary, as they have on each Sept. 11.

Charles Figley, professor of disaster mental health at Tulane University’s School of Social Work and a former Marine, advanced the concept of PTSD in a 1978 book on Vietnam War veterans. He said one reason the trauma had been so hard to shake was that it ripped at the most ordinary fabric of daily life.

The landmark is not a distant hill in Afghanistan that one will never see again. “It’s the places you see every day, where you proposed to your wife, where you remember getting the news that you got promoted, where your young children played,” Dr. Figley said.

“You go into a combat zone and then you leave,” he added. “You don’t leave home. You return all the time.”

Ancient but Evolving Illness

“The Iliad” described warriors consumed by feelings of guilt, rage and grief. World War I had “shell shock,” and World War II had “combat fatigue.” PTSD has been found in survivors of Nazi concentration camps, fires and railway accidents. But it was not until 1980, after the Vietnam War, that post-traumatic stress disorder was added to the psychiatric bible, the Diagnostic and Statistical Manual of Mental Disorders.

The current manual, the DSM-IV, says PTSD can develop through a range of exposures to death or injury: direct personal involvement, witnessing it or, if it concerns someone close, just learning about it. Almost no other psychiatric diagnosis has generated as much controversy, according to Dr. Robert L. Spitzer, a retired psychiatry professor from Columbia University and an expert in mental disorder classifications. It has become so vague that stressed-out college students and people who watched horror movies could fit the profile, he and two other experts wrote in a professional journal article.

“It’s a way of saying something terrible has happened to me and I’ve been damaged in some way, but that doesn’t necessarily mean it’s an illness,” Dr. Spitzer, who advocates tightening the criteria, said in an interview.

Some experts have been skeptical of studies finding that people suffered the disorder from watching television coverage of the Sept. 11 attacks. (Congress effectively excluded TV watchers from its treatment program by requiring that victims had lived or worked within certain geographic boundaries.)

Alain Delaquérière contributed research.

Treatment for Leukemia Is Showing Early Promise

Posted: 10 Aug 2011 10:10 PM PDT

Scientists are reporting very preliminary success with a new approach for treating leukemia — turning the patients’ own blood cells into assassins that hunt and destroy their cancer cells.

So far, researchers have treated three patients with chronic lymphocytic leukemia, and their published paper reports the results for one of them. The patient had initially responded to chemotherapy but relapsed, leaving him only one option, a risky bone marrow transplant. So far, the researchers say, that patient and another leukemia patient appear cancer-free up to a year after treatment. The third patient improved but still has some cancer.

Papers describing the work were published Wednesday in The New England Journal of Medicine and Science Translational Medicine.

But an editorial in The New England Journal of Medicine urged caution, pointing out that there were complications with the therapy and that it was too soon to assess its effectiveness.

“Only with the more widespread use of” the therapy “will we learn whether the results reported by Porter et al. reflect an authentic advance toward a clinically applicable and effective therapy or yet another promising lead that runs into a barrier that cannot be easily overcome,” wrote the editorialists, Dr. Walter J. Urba of the Providence Cancer Center in Portland, Ore., and Dr. Dan L. Longo, a deputy editor at The New England Journal of Medicine.

But the study’s lead researcher, Dr. Carl June, was optimistic.

“It worked great; we were surprised it worked as well as it did,” said Dr. June, a gene therapy expert at the University of Pennsylvania. “We’re just a year out now. We need to find out how long these remissions last.”

Dr. June and his colleagues used a novel carrier to deliver the new genes into patients’ white blood cells — T cells — and added a signaling mechanism telling the T cells to kill and multiply.

The treatment had a potentially serious side effect, however. It depleted patients’ antibody producing cells, their B cells. That was, the investigators wrote, “an expected chronic toxic side effect.”

And, Dr. Urba said, “it’s still just three patients,” adding, “Three’s better than one, but it’s not 100.”

What happens long-term is key, he said: “What’s it like a year from now, two years from now, for these patients.”

Cuba-to-Florida Quest Defeats Swimmer at 61

Posted: 10 Aug 2011 10:50 PM PDT

MIAMI — Three miles off Havana on Sunday evening, the Florida Straits were still glasslike when the 61-year-old marathon swimmer Diana Nyad felt her right shoulder seize up with pain. But she kept swimming.

Enlarge This Image
Rob O'Neal/Florida Keys News Bureau, via Associated Press

Diana Nyad cried as she addressed reporters after cutting her attempt to swim from Cuba to Florida short.

Related

Enlarge This Image
Franklin Reyes/Associated Press

Ms. Nyad started her swim from offshore Havana on Sunday.

At 1:30 p.m. Monday, with the ocean swells now buffeting her, Ms. Nyad was struck by an asthma attack, her first ever, and struggled to breathe. But she kept swimming.

Nearly twelve hours later, halfway between Cuba and her destination of Key West, Fla., Ms. Nyad was treading water when she began vomiting. She then reluctantly allowed herself to be pulled aboard a support boat named the Bellissimo, where she was quickly wrapped in blankets. After swimming nearly 29 hours, Ms. Nyad abandoned her quest to complete the 60-hour, 103-mile journey, spread across three days, between Cuba and the United States.

“It was my decision to stop and nobody else’s,” Ms. Nyad said during a phone interview Tuesday morning moments after arriving at a Key West marina. “I’m deeply grieved and disappointed, but I can hold my head up high. We pictured that moment of me crawling up on that Key West shore. We knew it was my year and my time, even at 61.”

She added, “It was a fairy tale, but the fairy tale didn’t come true.”

Her doctor, Michael Broder, said Ms. Nyad had not suffered from dehydration but was violently vomiting when she was hoisted out of the water. “Physically, she is exhausted and mentally she is exhausted,” Dr. Broder said. “Considering what she has been through, she looks pretty good.”

Ms. Nyad said she had no regrets. She had concluded that the combination of her injured shoulder and the asthma attack made continuing impossible. “It was over, I knew it,” she said. “My body was at the absolute very end. Willpower wasn’t a part of it anymore.”

Ms. Nyad, a commentator for the Los Angeles public radio station KCRW, began her “Xtreme Dream” journey on Sunday evening. She was the first person to attempt the swim without a shark cage. Moments before slipping into the water at Hemingway Marina on the outskirts of Havana, Ms. Nyad, clad in a black swimsuit and a blue swim cap, played reveille on a bugle. “I’m almost 62 years old,” she declared. “I’m standing here at the prime of my life; I think this is the prime, when one reaches this age. You still have a body that’s strong, but now you have a better mind.”

On Tuesday morning, she said that her goal had been to demonstrate to people in their 60s that “life is not over” and that the age of “60 is the new 40.”

“I wasn’t the best swimmer I could be — the asthma and the shoulder made sure of that,” she said. “I was my most courageous self.”

At the age of 29, Ms. Nyad set a record for the longest ocean swim: 102.5 miles from Bimini in the Bahamas, to Jupiter, Fla. A year earlier, she had tried to swim the Cuba-to-Key West passage. Strong currents and rough water had banged her body against a metal shark cage, forcing her to quit after swimming 41 hours and 49 minutes.

This time, she tried the swim without a shark cage despite warnings that the warm waters are infested with sharks. She was guarded by a flotilla of boats equipped with satellites, Global Positioning System devices, advanced navigation systems and shark shields.

In 1997, an Australian endurance swimmer named Susie Maroney, swimming inside a shark cage, crossed from Havana to Key West in 24 hours, 30 minutes, an unusually fast time that led some to conclude that the cage helped her make it that fast.

Ms. Nyad had trained and prepared nearly two years for this week’s swim. She swam 12 hours every other day; in between, she lifted weights. She also organized a group of 22 people to support her. All of them, with visas, accompanied her to Cuba last week.

Ms. Nyad said she did not feel as if she had let them down, or the thousands of fans who had followed the progress of her swim on Facebook and Twitter. “I’ll say this for myself and my team — there is no way 30 hours should have brought me to my knees,” she said. “Even yesterday afternoon, I really believed I was going to walk up on that shore, even though it wouldn’t be the way I had wanted it to be.”

The passage between Cuba and the United States carried important symbolism for Ms. Nyad and her friends. “I don’t know if there is a more famous stretch of ocean than the one between Cuba and Florida,” she explained. “How many Cubans are on the bottom of the ocean who didn’t make it across? Our countries are so close — you can almost swim across.”

Will Ms. Nyad try the 103-mile swim again? No, she said quickly.

“I think I’m going to live a life when I did not swim from Cuba to Florida,” she said. “I think I can live with that.”

She added that she hopes her quest might inspire others her age to begin energizing their lives with exercise. “Life goes by so quickly and, at my age, you really feel the passage of time,” she said. “People my age must try to live vital, energetic lives. We’re still young. We’re not our mothers’ generation at 60.”

For people over 60, she said, the goal should be “to live a life with no regrets and no worries about what you are going to do with your time. Fill it with passion. Be your best self.”

New York City Will Mandate Sex Education

Posted: 10 Aug 2011 02:17 PM PDT

For the first time in nearly two decades, students in New York City’s public middle and high schools will be required to take sex-education classes beginning this school year, using a curriculum that includes lessons on how to use a condom and the appropriate age for sexual activity.

Related

Related in Opinion
Room For Debate

How to Close the Race Gap in H.I.V.?

How can public health officials fight the spread of H.I.V. among young gay black men?

Metro Twitter Logo.

Connect With Us on Twitter

Follow @NYTMetro for New York breaking news and headlines.

The new mandate is part of a broader strategy the Bloomberg administration announced last week to improve the lives of black and Latino teenagers. According to city statistics, those teenagers are far more likely than their white counterparts to have unplanned pregnancies and contract sexually transmitted diseases.

“It’s obviously something that applies to all boys and all girls,” said Linda I. Gibbs, the deputy mayor for health and human services. “But when we look at the biggest disadvantages that kids in our city face, it is blacks and Latinos that are most affected by the consequences of early sexual behavior and unprotected sex.”

The change will bring a measure of cohesion to a patchwork system of programs largely chosen by school principals.

It will also bring to New York the roiling national debate about what, exactly, schools should teach students about sex.

Nationwide, one in four teenagers between 2006 and 2008 learned about abstinence without receiving any instruction in schools about contraceptive methods, according to an analysis by the Guttmacher Institute, which studies reproductive health. As of January, 20 states and the District of Columbia mandated sex and H.I.V. education in schools. An additional 12 states, New York included, required H.I.V. education only, according to a policy paper published by the institute.

New York City’s new mandate goes beyond the state’s requirement that middle and high school students take one semester of health education classes. The city’s mandate calls for schools to teach a semester of sex education in 6th or 7th grade, and again in 9th or 10th grade, suggesting they use HealthSmart and Reducing the Risk, out-of-the-box sets of lessons that have been recommended since 2007. A city survey of principals last year found that 64 percent of middle schools were using the HealthSmart curriculum.

For the Bloomberg administration, which last week announced a three-year, $130 million initiative to improve the lives of young minority men in the city, the sex-education mandate joins a number of other public health efforts — like the mayor’s push to reduce residents’ intake of salt and sugary sodas — that have sometimes been criticized as interventionist. It is also unusual because the city does not often tell schools what to teach.

“We have a responsibility to provide a variety of options to support our students, and sex education is one of them,” the chancellor, Dennis M. Walcott, said in an interview on Monday.

Parents will be able to have their children opt out of the lessons on birth-control methods. City officials said that while there would be frank discussions with students as young as 11 on topics like anatomy, puberty, pregnancy and the risks of unprotected sex, the focus was to get students to wait until they were older to experiment. At the same time, knowing that many teenagers are sexually active, the administration wants to teach them about safe sex in the hopes of reducing pregnancy, disease and dropouts.

Some are already preparing for a backlash.

“We’re going to have to be the bridge between the chancellor’s requirements and the community,” said Casimiro Cibelli, principal of Middle School 142 in the Baychester section of the Bronx, where many of the students come from immigrant, religious families with traditional views on sex. “Hopefully, we’ll allay their concerns because of their trust in us.”

At Mr. Cibelli’s school, the current semester-long health course does not stray from subjects like nutrition and physical fitness.

The new classes, which will be coeducational, could be incorporated into existing health education classes, so principals will not have to scramble to find additional instructional time. The classes would include a mix of lectures, perhaps using statistics to show that while middle school students might brag about having sex, not many of them actually do; group discussions about, for example, why teenagers are often resistant to condoms; and role-playing exercises that might include techniques to fend off unwanted advances. 

Schools that have not been offering sex education — the number is unclear because the city’s Department of Education has not kept a tally, a spokeswoman said — can hire a teacher to do it or assign the task to one who is already on the staff. The department will offer training sessions before the start of classes Sept. 8.

Some New Yorkers of older generations remember explicit sex-education classes with frank talk about libido and demonstrations of how to use a diaphragm.

In 1987, the state mandated the adoption of an H.I.V./AIDS curriculum in every school. For students in the city, that has meant at least five class sessions each year, from kindergarten through 12th grade. In those classes, younger students are taught to avoid touching open wounds, and older ones are talked to about sex, but not necessarily about preventing pregnancies.

Opposition from religious groups and school board members eventually defeated a city mandate approved in the 1980s for a sex-education curriculum. But a survey by NARAL Pro-Choice New York in 2009 found that 81 percent of city voters thought sex education should be taught in public schools.

High schools in New York have been distributing condoms for more than 20 years. In the new sex-education classes, teachers will describe how to use them, and why, going where some schools have never gone before. To others, though, the topic will be familiar territory.

At John Dewey High School in Gravesend, Brooklyn, 10th graders already take a nine-week course called Human Sexuality, which the school’s health teachers designed some years ago and which covers many of the same topics that the city will require.

Some schools have relied on nonprofit or community groups like Planned Parenthood and the Door to teach their sex-education classes, an arrangement that is likely to continue once the new policy takes effect.

Mary Cheng, a health teacher at Murry Bergtraum High School in Lower Manhattan, said she devoted two months of students’ required five-month health class to sex education, combining lessons from the recommended high school curriculum with materials of her own. Ultimately, it will be up to schools to design the lessons; they will have until the beginning of the second semester to begin the classes.

“We will work with our schools and school communities to ensure they are prepared,” Mr. Walcott said.

The New Old Age Blog: My House, Our Home

Posted: 09 Aug 2011 09:07 AM PDT

18 and Under: ‘Environment’ Poses a Knotty Challenge in Autism

Posted: 09 Aug 2011 08:49 AM PDT

Parents of children with autism often ask pediatricians like me about the cause of the condition, and parents-to-be often ask what they can do to reduce the risk. But although there is more research in this area than ever before, it sometimes feels as if it’s getting harder, not easier, to provide answers that do justice to the evidence and also offer practical guidance.

Enlarge This Image
Yarek Waszul

Well

Share your thoughts on this column at the Well blog.

Go to Well »

Multimedia
Interactive Feature
Patient Voices: Autism

Related

Recent research has taught us more about the complexity of the genetics of autism, but the evidence also has suggested an important role for environmental exposures. It has become a very complicated picture: Genes matter, but we usually can’t tell how. Environmental exposures matter, but we usually don’t know which.

In July, a study of autism in twins was published online in Archives of General Psychiatry. Researchers looked at almost 200 sets of twins in California. In each pair, one twin was autistic.

The study sought to determine how likely the second twin was to have some form of autism. If autism was highly heritable, identical twins should have been far more likely to both have autism than fraternal twins. But the researchers found that fraternal twins were unexpectedly likely to both have autism.

The implication is that something in their common gestational or early childhood experience may have contributed to this similarity.

“The data definitely did surprise me,” said Dr. Joachim Hallmayer, the lead author of the study and an associate professor of psychiatry and behavioral sciences at Stanford University. “I expected the fraternal twin rates to be lower than what we found.”

This new twin study supported the importance of genetics, but also the role of environmental exposures — and that is part of a general shift in how autism is being discussed.

In the 1950s, autism famously was blamed on bad parenting and emotionally remote “refrigerator mothers.” As the research advanced, including early important twin studies, the inherited basis of the disorder became clear. In a 2010 article published in an American Psychiatric Association journal, autism spectrum disorder is described as “among the most heritable of psychiatric disorders.”

Yet in recent years, researchers have implicated a variety of possible environmental associations as well. Today many scientists believe autism results both from genetic predisposition and from environmental influence.

But “environment” is a tricky word. To many scientists studying autism, it means “everything that’s not the inherited DNA,” said Irva Hertz-Picciotto, a professor of epidemiology at the University of California, Davis, MIND Institute. An environmental influence might be a chemical the fetus is exposed to via the placenta, or it might refer to aspects of nutrition, maternal health, stress — or perhaps exposure to a microbe.

The causal links most strongly supported by research include rubella infection during pregnancy and prenatal exposure to medications like thalidomide and valproic acid, an anti-seizure drug. Other environmental factors, like air pollution and exposure to certain pesticides and other chemicals, have been found to be associated with autism, but without evidence of causality.

In a 2010 paper in the journal NeuroToxicology, Dr. Amir Miodovnik, a pediatrician at the Mount Sinai School of Medicine, and his colleagues showed that children who had been exposed to high levels of phthalates prenatally were more likely to show social impairments at 7 to 9 years of age.

Phthalates, chemicals found in many consumer products, are so-called endocrine disruptors, hormonally active substances that can interfere with a variety of developmental processes, including brain development. Yet these data don’t demonstrate cause and effect, Dr. Miodovnik said, “only that these substances are associated with symptoms found in autism.” Conversely, taking prenatal vitamins around the time of conception has been associated with a lower risk of autism in a recent study.

These epidemiologic associations may point us in the direction of still other factors involved in the making of autism. “Every case is probably a result of the confluence of many factors,” Dr. Hertz-Picciotto said. “No case probably has one cause.”

So it’s hard — and frustrating — to offer prospective parents advice about avoiding risks we still can’t clearly identify and factors that may differ from family to family. But some advice seems well grounded, if unsurprising: Take prenatal vitamins before trying to conceive. Make sure your immunizations are up to date. Get good prenatal care. Talk to your doctor about the risks and benefits of any medications you take.

Dr. Miodovnik points out that potentially toxic substances are ubiquitous and cannot be completely avoided, but suggests that prospective parents try to avoid pesticides, don’t microwave plastics that may contain endocrine disruptors, and consider choosing fragrance-free personal products (phthalates are used in many fragrances).

Still, it’s hard to talk about this without terrifying parents. And I wonder if in giving advice about prevention, we risk repeating the errors of the past, making parents feel they’re to blame for a child’s autism because they failed to micromanage an environment full of complex agents with potential to interact with fetal genes in a range of damaging but poorly understood disruptions.

Learning more and understanding more ought to make us more helpful to parents, and of course to children. We respect them by acknowledging that there is nothing simple in the development of autism: The causes are genetic, and not simple, and environmental, and not simple. And if the studies tell us anything clearly, it is that we have much to learn about the interplay of genes and environmental exposure and the individuality of this complex disorder.

Well Blog: The Sandwich Gets a Makeover

Posted: 12 Aug 2011 08:23 AM PDT

Well Blog: Do Patients Have the Toughest Job in Medicine?

Posted: 12 Aug 2011 08:30 AM PDT

Well Blog: Arthritis and the Exercise Gap

Posted: 12 Aug 2011 08:38 AM PDT

Well Blog: How Tanning Changes the Brain

Posted: 12 Aug 2011 08:24 AM PDT

Well Blog: More Children Hospitalized With Skin Infections

Posted: 11 Aug 2011 09:34 AM PDT

Room For Debate: How to Close the Race Gap in H.I.V.?

Posted: 10 Aug 2011 02:45 PM PDT

The Two-Minus-One Pregnancy

Posted: 12 Aug 2011 08:40 AM PDT

As Jenny lay on the obstetrician’s examination table, she was grateful that the ultrasound tech had turned off the overhead screen. She didn’t want to see the two shadows floating inside her. Since making her decision, she had tried hard not to think about them, though she could often think of little else. She was 45 and pregnant after six years of fertility bills, ovulation injections, donor eggs and disappointment — and yet here she was, 14 weeks into her pregnancy, choosing to extinguish one of two healthy fetuses, almost as if having half an abortion. As the doctor inserted the needle into Jenny’s abdomen, aiming at one of the fetuses, Jenny tried not to flinch, caught between intense relief and intense guilt.

Motherlode

Adventures in parenting. Visit the blog posts on pregnancy »

Katherine Wolkoff for The New York Times

“Things would have been different if we were 15 years younger or if we hadn’t had children already or if we were more financially secure,” she said later. “If I had conceived these twins naturally, I wouldn’t have reduced this pregnancy, because you feel like if there’s a natural order, then you don’t want to disturb it. But we created this child in such an artificial manner — in a test tube, choosing an egg donor, having the embryo placed in me — and somehow, making a decision about how many to carry seemed to be just another choice. The pregnancy was all so consumerish to begin with, and this became yet another thing we could control.”

For all its successes, reproductive medicine has produced a paradox: in creating life where none seemed possible, doctors often generate more fetuses than they intend. In the mid-1980s, they devised an escape hatch to deal with these megapregnancies, terminating all but two or three fetuses to lower the risks to women and the babies they took home. But what began as an intervention for extreme medical circumstances has quietly become an option for women carrying twins. With that, pregnancy reduction shifted from a medical decision to an ethical dilemma. As science allows us to intervene more than ever at the beginning and the end of life, it outruns our ability to reach a new moral equilibrium. We still have to work out just how far we’re willing to go to construct the lives we want.

Jenny’s decision to reduce twins to a single fetus was never really in doubt. The idea of managing two infants at this point in her life terrified her. She and her husband already had grade-school-age children, and she took pride in being a good mother. She felt that twins would soak up everything she had to give, leaving nothing for her older children. Even the twins would be robbed, because, at best, she could give each one only half of her attention and, she feared, only half of her love. Jenny desperately wanted another child, but not at the risk of becoming a second-rate parent. “This is bad, but it’s not anywhere as bad as neglecting your child or not giving everything you can to the children you have,” she told me, referring to the reduction. She and her husband worked out this moral calculation on their own, and they intend to never tell anyone about it. Jenny is certain that no one, not even her closest friends, would understand, and she doesn’t want to be the object of their curiosity or feel the sting of their judgment.

This secrecy is common among women undergoing reduction to a singleton. Doctors who perform the procedure, aware of the stigma, tell patients to be cautious about revealing their decision. (All but one of the patients I spoke with insisted on anonymity.) Some patients are so afraid of being treated with disdain that they withhold this information from the obstetrician who will deliver their child.

What is it about terminating half a twin pregnancy that seems more controversial than reducing triplets to twins or aborting a single fetus? After all, the math’s the same either way: one fewer fetus. Perhaps it’s because twin reduction (unlike abortion) involves selecting one fetus over another, when either one is equally wanted. Perhaps it’s our culture’s idealized notion of twins as lifelong soul mates, two halves of one whole. Or perhaps it’s because the desire for more choices conflicts with our discomfort about meddling with ever more aspects of reproduction.

Ruth Padawer (ruthpadawer@yahoo.com) is a writer and teacher. Her most recent article for the magazine was about how DNA testing is changing fatherhood.

Editor: Vera Titunik (v.titunik-MagGroup@nytimes.com)

Personal Health: A Campaign to Carry Pregnancies to Term

Posted: 09 Aug 2011 10:45 AM PDT

The March of Dimes opened a new campaign this summer to curb the large and growing number of otherwise healthy pregnancies that are deliberately ended early by induced labor or Caesarean delivery.

Enlarge This Image
Yvetta Fedorova

Related

Research has clearly shown that a change in approach that emphasizes allowing babies to develop fully when both mother and baby are doing well could result in healthier babies and lower medical costs. The campaign is called “Healthy babies are worth the wait.”

What prompted the campaign is what many experts view as an alarming trend in American obstetrics — the steady rise in elective deliveries of singleton babies before 39 weeks of gestation, when fetal development is complete. Gestation is calculated from the first day of a woman’s last menstrual period. Studies have shown that as many as 36 percent of elective deliveries now occur before 39 weeks, and many of these early deliveries are contributing to an unacceptable number of premature births and avoidable, costly complications.

Although guidelines issued 12 years ago by the American College of Obstetricians and Gynecologists cautioned against elective delivery by induction or Caesarean before 39 weeks, an overwhelming majority of new mothers and many doctors who deliver babies believe it is just as safe for birth to occur weeks earlier.

Complications

But the medical facts say otherwise. With each decreasing week of gestation below 39 to 40 weeks, there is an increased risk of complications like respiratory distress, jaundice, infection, low blood sugar, extra days in the hospital (including time in the neonatal intensive care unit), and even deaths of newborn babies and older infants.

Although tests may show that the baby’s lungs are well developed at, say, 37 weeks, research has demonstrated that the risk of newborn complications is still significantly higher than if delivery occurs two to three weeks later. In a study published last December of babies demonstrated to have mature lungs before birth, those delivered at 36 to 38 weeks had two and a half times the number of complications compared with those delivered at 39 to 40 weeks. Problems more common among babies delivered earlier in gestation included respiratory distress, jaundice and low blood sugar.

Yet in 2008 among a national sample of 650 women who had recently given birth, 51.7 percent chose 34 to 36 weeks of gestation as “the earliest point in pregnancy that it is safe to deliver the baby” and 40.7 percent chose 37 to 38 weeks. Only 7.6 percent selected 39 to 40 weeks, the true length of a full-term pregnancy, and the time when complications, including stillbirth, are least likely to occur.

Although many women think that weight gain is all that happens to babies during the last few weeks of pregnancy, Dr. Eve Lackritz, chief of the maternal and infant health branch of the national Centers for Disease Control and Prevention in Atlanta, said vital organs like the brain, lungs and liver are still developing. There are also fewer vision and hearing problems among babies born at full term.

“Babies aren’t fully developed until at least 39 weeks,” Dr. Lackritz told a news briefing in New York convened by the March of Dimes. For example, a baby’s brain at 35 weeks gestation weighs only two-thirds of what it will weigh at 39 to 40 weeks.

“If there are no medical complications, the healthiest outcome for both mother and infant is delivery at 40 weeks,” Dr. Lackritz said.

This is not to suggest that women should panic if labor begins earlier on its own. “It’s a whole different story when a woman goes into labor early than when labor is induced,” Dr. Uma M. Reddy of the National Institute of Child Health and Human Development said in an interview. She explained that the labor process helps to prevent lung problems. At the same gestational age, there are fewer respiratory problems when labor occurs naturally than when it is medically induced, Dr. Reddy said.

Dr. Reddy and colleagues analyzed more than 46 million singleton live births that occurred from 1995 to 2006 and found that newborn death rates at 37 weeks of gestation were two and a half to nearly three times the number at 40 weeks and were also elevated at 38 weeks of gestation. For example, in 2006 the infant mortality rate at 37 weeks gestation was 3.9 per 1,000 live births; at 38 weeks, 2.5 per 1,000 births; and at 40 weeks, 1.9 per 1,000 births. They reported their findings in the journal Obstetrics & Gynecology in June. The researchers also found that these so-called early-term births were associated with higher rates of death after birth and during infancy than were full-term births occurring at 39 to 41 weeks.

Dr. Reddy said that the textbook definition of “term pregnancy” as one that lasts from 37 to 41 weeks “is arbitrary — it has no biological basis. If a woman’s water hasn’t broken, if labor hasn’t begun on its own, if there are no medical or obstetrical problems, there’s no reason for a woman to be delivered before 39 weeks.”

The recommendation applies not just to women whose labor is induced, but also to those having a scheduled Caesarean delivery. Too often, women are mistaken about when they got pregnant, which can throw off the calculation of their due date. Even when a “dating” ultrasound is done during the first trimester of pregnancy, there can be as much as a two-week margin of error. Thus, a woman may think her pregnancy has lasted 39 weeks when it is only 37 weeks along. Or she may think she is 37 weeks pregnant when she is only 35 weeks; a delivery at that point would result in a premature birth.

Countering Early Elective Births

Dr. Reddy pointed out that “late preterm births” — between 34 and 37 weeks of gestation — in pregnancies with no complications are more common among older white women with higher levels of education who “are more likely to ask their obstetricians to deliver them before term.”

Well-educated women may be more inclined to want to schedule birth at a convenient time for themselves and other family members. Doctors, too, may suggest an elective delivery so that birth occurs at a time that best suits their schedules, including office hours and vacation times. Sometimes doctors, fearing a malpractice suit if something should go wrong if a pregnancy proceeds to term, choose to deliver babies early when they are alive and well.

To counter the avoidable complications and higher costs associated with preterm elective deliveries, beginning in January 2001 a network of nine urban hospitals in the Intermountain Healthcare system in Utah instituted a program to greatly limit elective deliveries before 39 weeks of gestation. The program included educational programs for doctors, nurses and pregnant women. However, not until strict monitoring of births was instituted by the hospitals did the rate of early deliveries drop to less than 3 percent from 28 percent, with a host of benefits but “no adverse effects” seen on the health of the mothers or babies.

Really?: The Claim: For Better Hydration, Drink Coconut Water

Posted: 08 Aug 2011 11:48 AM PDT

The New Old Age Blog: The Elderly, at Home in Manhattan

Posted: 12 Aug 2011 01:16 PM PDT

Deal in Place for Inspecting Foreign Drugs

Posted: 12 Aug 2011 10:20 PM PDT

More than 80 percent of the active ingredients for drugs sold in the United States are made abroad, mostly in a shadowy network of facilities in China and India that are rarely visited by government inspectors, who sometimes cannot even find the plants.

Enlarge This Image
Jeff Swensen for The New York Times

Heather Bresch's proposal to tax the generic drug industry to aid inspections was largely adopted.

RSS Feed

RSS Get Science News From The New York Times »

But after decades of failed attempts, the federal government and the generic drug industry have reached an agreement that is almost certain to pass Congress and that will lead to routine inspections of these overseas plants, potentially transforming the enormous global medicine trade.

Under the landmark agreement, expected to be completed within weeks, generic drug companies — which make 75 percent of the prescription medicines sold in the United States — would pay $299 million in annual fees to underwrite inspections of foreign manufacturing plants every two years, the same frequency required of domestic plants.

Self-interest helped drive the agreement because the industry will not only get speedier approvals of new products as part of the deal but also may avoid scandals involving tainted medicines, which tend to hurt confidence in the entire industry.

At its present pace, the Food and Drug Administration would need more than 13 years to inspect every foreign drug plant exporting to the United States. Some plants have never been inspected, which saves them huge sums in cleanup and other compliance costs — an important reason that drug manufacturing is disappearing from the United States and that tainted-drug scandals occur.

In one infamous case, Chinese manufacturers deliberately substituted a cheap fake for the dried pig intestines used to make the blood-thinning drug heparin. The tainted drug was linked to 81 deaths and exposed tens of thousands of people to danger. The F.D.A. never inspected the plants making the crucial ingredients, a larger problem that only now, more than three years later, may be fixed.

“This agreement is epoch-making,” said Guy Villax, chief executive of Hovione, a generic drug maker with plants in New Jersey, Europe and China. Supply chains for many generic drugs often contain dozens of middlemen and “are highly susceptible to being infiltrated by falsified” drugs, Mr. Villax said.

Dr. Margaret Hamburg, commissioner of the F.D.A., said she was pleased with the generic drug fee proposals. “If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough,” Dr. Hamburg said. “F.D.A.’s entire generic drug program would be placed on a much more stable footing.”

The agreement will not affect the making of over-the-counter medicines or vitamins, whose global supply chains are even more vulnerable to tampering since government inspectors almost never visit their makers. Aspirin and vitamin C supplements, among others, are now made almost entirely in uninspected plants in China.

Nor will the agreement change the F.D.A.’s oversight of name-brand prescription medicines. Although branded drugs usually have more secure supply chains than those of generics, major pharmaceutical companies have moved aggressively into China in recent years and often rely on rarely inspected suppliers.

Federal officials for years have expressed concerns about the nation’s growing reliance on sometimes mysterious foreign drug suppliers, but they had largely despaired of fixing the problem. Congress has never given the F.D.A. the money needed to inspect these plants, and for nearly two decades the generic drug industry resisted proposals to pay inspection fees.

The industry changed its stance for several reasons. First, the heparin scandal scared everyone. The fake ingredient was good enough to pass a sophisticated test, so the conspirators probably knew that deaths would result, reflecting a callous level of greed. And the Chinese government refused to allow the F.D.A. to investigate, suggesting that the perpetrators were not only smart but politically well connected.

Second, the generic drug industry is no longer a motley collection of struggling mom-and-pop companies. Years of consolidation have created giants like Israel-based Teva Pharmaceuticals that understand that their businesses depend on winning the confidence of patients and regulators alike, and they can afford to pay the fees needed to achieve that confidence.

This posting includes an audio/video/photo media file: Download Now

Paul Meier, Statistician Who Revolutionized Medical Trials, Dies at 87

Posted: 13 Aug 2011 12:40 AM PDT

Paul Meier, a leading medical statistician who had a major influence on how the federal government assesses and makes decisions about new treatments that can affect the lives of millions, died on Sunday at his home in Manhattan. He was 87.

Enlarge This Image

Paul Meier

The cause was complications of a stroke, his daughter Diane Meier said.

As early as the mid-1950s, Dr. Meier was one of the first and most vocal proponents of what is called “randomization.”

Under the protocol, researchers randomly assign one group of patients to receive an experimental treatment and another to receive the standard treatment. In that way, the researchers try to avoid unintentionally skewing the results by choosing, for example, the healthier or younger patients to receive the new treatment.

If the number of subjects is large enough, the two groups will be the same in every respect except the treatment they receive. Such randomized controlled trials are considered the most rigorous way to conduct a study and the best way to gather convincing evidence of a treatment’s effects.

Before randomization, the science of clinical trials was imprecise. Researchers, for example, would give a new treatment to patients who they thought might benefit and compare the outcomes to those of previous patients who were not treated, a method that could introduce serious bias.

The Food and Drug Administration requires randomized trials before approving new drugs, and the National Institutes of Health spend large parts of their budget conducting randomized clinical trials.

Among the other leading advocates of randomization was Sir Richard Peto, a renowned researcher at Oxford University. In an e-mail, Mr. Peto said that Dr. Meier, “perhaps more than any other U.S. statistician, was the one who influenced U.S. drug regulatory agencies, and hence clinical researchers throughout the U.S. and other countries, to insist on the central importance of randomized evidence.”

“That strategic decision half a century ago has already saved millions of lives,” Mr. Peto continued, “and those millions should be attributed to Paul.”

Perhaps as significant to the field of medical statistics was Dr. Meier’s cooperation with Edward L. Kaplan, a researcher at the University of California Radiation Laboratory, in formulating a now widely accepted standard for estimating patient survival. (Dr. Kaplan died in 2006.)

In a paper published in the Journal of the American Statistical Association in June 1958, the collaborators put forth a new, efficient method for estimating patient survival rates, taking into account the fact that some patients die during research trials while others survive beyond the trials. The method, called the Kaplan-Meier estimator, is based on a complex mathematical formula using information from those who died and those who survived to estimate (depicted in a curve) the proportion of patients alive at any point during the trial.

“If you have a patient with breast cancer receiving a particular treatment or drug, you can estimate her 5-, 10- or 15-year survival rate,” Theodore Karrison, a researcher at the University of Chicago, said Thursday. “It has become the standard tool used by medical researchers for determining the duration of survival in thousands of studies, ranging from cancer to AIDS to cardiovascular disease to diabetes, to name just a few.”

Today, almost every medical study includes Kaplan-Meier curves. And the original paper is one of the most widely quoted in medical literature, having been cited more than 35,000 times, according to the Thomson Reuters Web of Knowledge, a Web site that maintains citation databases.

Born in Newark on July 24, 1924, Paul Meier was one of two sons of Frank and Clara Meier. His father was a chemist; his mother, a school principal.

Besides his daughter Diane, Dr. Meier is survived by his wife of 63 years, the former Louise Goldstone; two other daughters, Karen Meier and Joan Meier; and five grandchildren.

Dr. Meier received his bachelor’s degree in physics and mathematics from Oberlin in 1945, then earned his master’s in mathematical logic in 1947 and his doctorate in statistics in 1951, both at Princeton. He taught at Lehigh from 1948 to 1952, at Johns Hopkins until 1957 and then joined the faculty at the University of Chicago, where he became chairman of the statistics department. He later taught at Columbia.

Researchers were not always attuned to Dr. Meier’s advocacy. “When I said ‘randomize’ in breast cancer trials,” he recalled in a 2004 interview for Clinical Trials, the publication of the Society for Clinical Trials, “I was looked at with amazement by my medical colleagues: ‘Randomize? We know that this treatment is better than that one.’ I said, ‘Not really!’ ”

On Thursday, Robert T. O’Neill, director of the Office of Biostatistics at the Federal Drug Administration’s Center for Drug Evaluation and Research, said that as a member of the agency’s advisory committee, Dr. Meier “forcefully expressed the statistical principles that we follow today, particularly randomization and the follow-up of patients.”

“When Paul spoke, people listened, and few could spar with him.”

Health Law Is Dealt Blow by a Court on Mandate

Posted: 12 Aug 2011 10:00 PM PDT

The provision in President Obama’s health care law requiring Americans to buy health insurance or face tax penalties was ruled unconstitutional on Friday by the United States Court of Appeals for the 11th Circuit, in Atlanta.

Multimedia
Interactive Feature
The Growing Legal and Political Opposition
INTERACTIVE FEATURE: Appeals Court Ruling Against Health Law Mandate

It was the first appellate review to find the provision unconstitutional — a previous federal appeals court upheld the law — and some lawyers said that the decision made it more likely that the fate of the health care law would ultimately be decided by the Supreme Court.

The court found that Congress exceeded its powers to regulate commerce when it decided to require people to buy health insurance, a provision of the health care law known as the “individual mandate.” But the court held that while that provision was unconstitutional, the rest of the wide-ranging law could stand.

A 2-to-1 majority ruled that the mandate was beyond Congress’s power under the Commerce Clause of the Constitution, writing that “what Congress cannot do under the Commerce Clause is mandate that individuals enter into contracts with private insurance companies for the purchase of an expensive product from the time they are born until the time they die.”

The 11th Circuit case may have been the most closely watched of the health law cases wending their ways through the courts, in part because its plaintiffs included Republican governors and attorneys general from 26 states. But it was just the second of at least three appellate reviews. The Obama administration prevailed in the first round in June, when the individual mandate was found to be constitutional by the United States Court of Appeals for the Sixth Circuit, in Cincinnati. The next opinion is expected shortly from the Fourth Circuit in Richmond, Va.

Supporters and opponents of the law, known as the Affordable Care Act, expect that the Supreme Court will eventually decide the issue. Some lawyers said the fact that the Atlanta court created a conflict among courts of appeals made it more likely that the Supreme Court would hear the case as early as its next term, which starts in October.

The health care law — passed in 2010 after more than a year of wrangling, and frequently criticized by Republican presidential candidates and members of Congress — is intended to insure 32 million Americans by mandating that most people obtain health insurance, subsidizing policies for the poor and requiring insurers to accept people with pre-existing health problems.

Supporters of those provisions, which take effect in 2014, argue that without the insurance mandate, which brings more people into the insurance pool, it is unreasonable to require insurers to cover all applicants regardless of their health status.

The Cincinnati court ruled that the mandate was constitutional. The Atlanta court disagreed, in a majority opinion written by Chief Judge Joel F. Dubina, who was appointed by the first President George Bush, and Judge Frank M. Hull, who was named by President Bill Clinton. Judge Stanley Marcus, another Clinton appointee, wrote a dissent.

The majority opinion said, “This economic mandate represents a wholly novel and potentially unbounded assertion of Congressional authority: the ability to compel Americans to purchase an expensive health insurance product they have elected not to buy, and to make them re-purchase that insurance product every month for their entire lives.”

Their opinion overturned the part of a lower court ruling that would have thrown out the entire health care law: they ruled that while the individual mandate was unconstitutional, the rest of the law could stand.

The White House and the Department of Justice said they were confident that the law was constitutional.

Kevin Sack contributed reporting.

F.T.C. Questions Bid to Spur Competition Between Drug Stores and Mail-Order Pharmacies

Posted: 13 Aug 2011 12:06 AM PDT

The Federal Trade Commission has issued an advisory opinion questioning a proposed New York State law intended to make it easier for neighborhood drug stores to compete with mail-order pharmacies.

Metro Twitter Logo.

Connect With Us on Twitter

Follow @NYTMetro for New York breaking news and headlines.

The opinion was quietly released on Monday and has stirred up a storm of protest from local pharmacists, who contend that they can provide drugs as cheaply as, if not cheaper than, mail-order pharmacies do, while offering a higher level of customer service.

The bill, which has passed both houses of the State Legislature, prohibits insurance plans, with some exceptions, from requiring that their members get their drugs from a mail-order pharmacy. It also forbids the plans from requiring a co-payment for a prescription filled at a retail pharmacy if a similar fee is not required for a mail-order prescription.

Josh Vlasto, a spokesman for Gov. Andrew M. Cuomo, declined to comment on the bill, saying it had not yet reached the governor’s desk.

The trade commission often asks its staff to weigh in on matters that may affect competition, although in this case its advice would not be binding.

In its opinion, the commission staff said that mail-order pharmacies were typically less expensive for consumers and insurers than retail pharmacies are, especially for long-term prescriptions, like those for diabetes, cholesterol and blood pressure drugs. Restricting the mail-order pharmacies’ exclusivity under some plans, the opinion said, would drive up prices for consumers and might force some plans to limit drug coverage.

Mail-order companies often provide discounts in return for a promise that an insurance plan will provide a high volume of patients, the trade commission’s staff said, and if they were not assured of getting that business, they would not provide the favorable prices.

“Although the bill attempts to provide consumers with a choice among available pharmacy providers, it may have the unintended consequences of curtailing prescription drug coverage and increasing out-of-pocket payments,” said the opinion, signed by Richard A. Feinstein, director of the trade commission’s bureau of competition, and other staff members.

Ray Macioci, president of the New York City Pharmacists Society, said on Friday that independent pharmacies had been able to offer low prices as generic drugs had become more common. Drug plans negotiated by labor unions would be exempt from the law, said Craig Burridge, executive director of the Pharmacists Society of the State of New York, if the unions required members to use mail-order pharmacies as a way of saving money. The opinion also drew a sharp response from another trade group, the National Community Pharmacists Association, which wrote to the commission claiming that the bill would give consumers more choice and thus increase competition rather than reducing it.

The association’s letter said that mail-order pharmacy companies had become so powerful that they were driving up costs and driving small independent pharmacies out of business.

The letter from the trade commission staff said that more than a dozen states had adopted laws on pharmacies like the proposed New York law, but that preliminary evidence showed that those laws did not save consumers money.

A study in Maryland, the commission said, found that statutory barriers to filling prescriptions by mail order had made long-term drugs “very costly for a state and its citizens.”

The staff letter said that while the trade commission understood that the bill was trying to give consumers a choice of where to fill their prescriptions, it was concerned that it “impedes a fundamental prerequisite to consumer choice: healthy competition between retail and mail-order pharmacies, which constrains costs and maximizes access to prescription drugs.”

Some Stealth Marketing by a ‘Hot Chemo’ Company

Posted: 11 Aug 2011 10:10 PM PDT

Dr. Jason M. Foster, a University of Nebraska surgeon, extolled the virtues of heated chemotherapy delivered directly into the abdominal cavity in a Web presentation in June. What he did not mention was that the Web site on which he appeared, HipecTreatment.com, is a marketing tool for ThermaSolutions, the leading manufacturer of equipment used for the controversial treatment.

Multimedia
Slide Show
A Controversial Cancer Treatment, Step by Step

Related

The moderator of the webcast, Glenn Keeling, is a founder and an executive at the company, though the Web site itself makes no mention of its connection to the company. Mr. Keeling and his brother Gary Keeling, the vice president for sales at ThermaSolutions, say they personally own the site. Still, one inducement for doctors to choose ThermaSolutions equipment is that their practices will be promoted on the Web site, according to doctors and industry executives.

As medical equipment goes, Hipec represents a tiny market, but one that is attracting more competitors. For example, Belmont Instrument is gaining market share at the expense of ThermaSolutions. A third company, ThermalTherapeutic Solutions, is entering the market. And even more companies are lining up.

The companies sell machines cleared by the Food and Drug Administration to circulate a heated sterile fluid through the abdomen. There are no medical claims made that this helps cancer patients.

When ThermaSolutions got its regulatory approval in 1999, it commissioned a market research study that said Hipec might be used for 20,000 cancer patients a year, Gary Keeling said.

There were only about 1,500 Hipec procedures done in the United States last year, he said.

ThermaSolutions, now based in St. Paul, has had a series of financial problems, management turnover and name changes. Mr. Keeling said the company was now owned by a Dutch holding company whose name he would not disclose.

He said ThermaSolutions’ machine was used in 68 of the roughly 80 hospitals in the United States that offered Hipec.

The biggest challenger, Belmont Instrument of Billerica, Mass., started off making equipment for the military to heat blood being transfused on the battlefield. Its machine is considerably smaller and lighter than the ThermaSolutions machine.

Lisa Fornicoia, director for sales and marketing at Belmont, said customers could buy its machine for $35,000 and then pay $410 a procedure for disposables. ThermaSolutions does not usually sell its machine, and charges something like $3,000 a procedure plus leasing fees.

Gary Keeling of ThermaSolutions declined to discuss the company’s price.

Thornton Hospital, part of the University of California, San Diego, switched to the Belmont equipment. “In one year, we saved $50,000,” said Dr. Andrew Lowy, a surgeon who performs the procedure there.

With competition heating up, Belmont has taken a page out of its rival’s book. It has started its own Web site, HipecDoctor.com. The only physicians listed as offering Hipec are those who use Belmont equipment.

Vital Signs: Longevity: Habits May Extend Life Only So Much

Posted: 09 Aug 2011 08:05 AM PDT

The eating, drinking and exercise habits of extremely old but healthy people differ little from those of the rest of us, a new study has found.

Related

Gerontologists at the Albert Einstein College of Medicine recruited 477 Ashkenazi Jews ages 95 to 112 who were living independently. The researchers took blood samples, did physical examinations and obtained detailed personal and medical histories from each participant. Then they compared them with 1,374 non-Hispanic white adults, ages 65 to 74, from the general population.

For both men and women, consumption of alcohol, amount of physical activity and the percentage of people on low-calorie or low-salt diets were almost identical in the two groups.

Long-lived men were less likely to be obese than their younger counterparts, although no less likely to be overweight. The oldest women were more likely to be overweight and less likely to be obese. More men among the oldest were nonsmokers, but smoking habits were not significantly different among the women.

Does this mean that it all depends on genes, and we might as well eat, drink and be merry? No, according to the senior author, Dr. Nir Barzilai, director of the Institute for Aging Research at Albert Einstein College of Medicine.

“For most of us who do not have genes for longevity,” he said, “if you follow the healthy lifestyle the medical community has put forth, you are much more likely to live past 80.”

The study was published online last week in The Journal of the American Geriatrics Society.

Vital Signs: Regimens: Soy Does Little for Menopause Symptoms

Posted: 08 Aug 2011 09:20 PM PDT

Fears about the risks of estrogen replacement therapy have led many women to turn to soy products to treat the symptoms of menopause. But a clinical trial published on Monday in Archives of Internal Medicine has found them no more effective than a placebo.

Related

Researchers at the University of Miami studied 248 women ages 45 to 60. Half were given 200 milligrams of soy isoflavones daily; the rest took a placebo. After two years the scientists tested for changes in bone mineral density and in menopausal symptoms.

Neither the women nor the researchers knew who was taking which pill until the study ended.

Urine tests showed that the women in the soy group had ingested nearly 20 times as much soy as those taking the placebo, but researchers found no significant differences in bone density. There were few serious effects in either group, but women taking soy showed no improvement regarding night sweats, insomnia, loss of libido or vaginal dryness, compared with the placebo group.

“Women should be reconsidering taking these types of products for menopausal health,” said Dr. Silvina Levis, lead author of the study and a professor of medicine at the University of Miami. “We didn’t see any objective clinical benefit for soy isoflavone supplements. We actually saw more constipation, bloating and hot flashes in the women taking soy.”

Vital Signs: Risks: Heart Risks May Hasten Mental Decline

Posted: 08 Aug 2011 09:20 PM PDT

Cardiovascular risk factors in middle age are associated with brain deterioration and a decline in mental function later in life, a new report has found.

Related

In a study published online last week in Neurology, scientists at the University of California, Davis, examined 1,352 men and women, ages 45 to 63, and recorded the group’s rates of hypertension, diabetes, smoking, high cholesterol, obesity and other risks.

The researchers also performed brain scans of the participants and administered several widely used tests of mental ability. No subject had symptoms of dementia at the start of the study.

In follow-up examinations 7 to 13 years later, the researchers found that high blood pressure at the start of the study was associated with an increased appearance of white areas on the scan, a sign of brain deterioration.

Midlife diabetes was associated with a greater annual increase in the size of the brain’s temporal horn, a marker of Alzheimer’s disease, in later years. And those with an increased waist-to-hip ratio had a significant decrease in total brain volume over time.

Obese people and those with hypertension eventually performed more poorly on tests of memory and mental skills, even after controlling for baseline cognitive performance, the researchers found.

Recipes for Health: Marinated Tofu Sandwich With Asian Greens

Posted: 11 Aug 2011 03:29 PM PDT

You won’t use all of the marinade for this sandwich, so add more tofu to it for another meal.

Recipes for Health

Martha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.

Related

1 1/2 teaspoons Asian sesame oil

2 tablespoons soy sauce, preferably low-sodium

1 tablespoon mirin (sweet Japanese rice wine)

1 1/2 teaspoons rice vinegar

2 teaspoons minced or grated fresh ginger

1/2 teaspoon sugar

3 ounces tofu, sliced 3/4 inch thick

1 small tomato, preferably a plum tomato that isn’t too juicy, sliced

1/2 small (3-ounce) avocado, sliced

A handful of Asian salad mix or wild arugula

2 slices whole-grain bread

1 teaspoon Dijon mustard

1 tablespoon mayonnaise

1/2 teaspoon wasabi paste or oil

1. Wrap the slices of tofu in a clean dish towel. Place on a cutting board and set another cutting board on top. Place a can of tomatoes or the equivalent on top of the cutting board to weigh down the board. Leave 20 minutes.

2. Mix together the sesame oil, soy sauce, mirin, rice vinegar, ginger and sugar in a wide bowl. Set the pressed tofu in the mixture, turn the slices over and leave to marinate 30 minutes.

3. Remove the tofu from the marinade, and pat dry with a paper towel.

4. Spread one piece of bread with mustard, and top with a mound of salad greens. Lay the tofu slices over the greens in a single layer. Lay the tomato slices over the tofu in a single layer. Top the tomatoes with the avocado slices. Stir together the mayonnaise and wasabi, and spread over the remaining piece of bread. Top the sandwich, press down firmly, cut in half and serve. Alternately, wrap in plastic, refrigerate and serve later.

Yield: One sandwich.

Advance preparation: The marinated tofu will keep for a week in the refrigerator. The sandwich will keep well for a day. Wrap tightly in plastic wrap and place in a bag. Keep cold if possible.

Nutritional information per serving: 422 calories; 3 grams saturated fat; 4 grams polyunsaturated fat; 6 grams monounsaturated fat; 5 milligrams cholesterol; 36 grams carbohydrates; 9 grams dietary fiber; 854 milligrams sodium (does not include salt to taste); 18 grams protein

Martha Rose Shulman is the author of "The Very Best of Recipes for Health."

Recipes for Health: Smoked Trout Salad, Cucumber and Roasted Pepper Sandwich

Posted: 10 Aug 2011 09:00 AM PDT

For this sandwich I use canned smoked trout — it’s packed in oil and not dry, so it lends itself to a mixture like tuna salad. I flake it in my mini-processor, then mix it up with a little yogurt and mayonnaise.

Recipes for Health

Martha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.

Related

One 3.9-ounce can smoked trout in canola oil

1 tablespoon plain yogurt

1 tablespoon mayonnaise

2 tablespoons finely diced celery

1 teaspoon minced fresh dill

2 small (3 1/2-inch) whole-wheat English muffins

About 1 1/2 ounces roasted red pepper

Sliced cucumber

A few drops lemon juice

1. Drain the trout. Place the fillets in a bowl or in the bowl of a mini-food processor, and flake them. Mix in the yogurt and 1 teaspoon of the mayonnaise. It should have the consistency of tuna salad. Stir in the chopped celery and dill.

2. Lightly toast the English muffins. Spread a little mayonnaise on both halves. Spread half the trout mixture over the muffin bottoms. Top with cucumber slices, and douse with a little lemon juice. Layer half the roasted pepper over the cucumber slices. Place the other halves of the English muffins on top, press down, slice in half if desired and serve. Alternately, you may wrap the sandwiches in plastic, refrigerate and serve later.

Yield: Two sandwiches.

Advance preparation: These sandwiches will keep well for a day. Wrap tightly in plastic wrap, and place in a bag. Keep cold if possible.

Nutritional information per serving: 282 calories; 1 gram saturated fat; 2 grams polyunsaturated fat; 3 grams monounsaturated fat; 27 milligrams cholesterol; 29 grams carbohydrates; 5 grams dietary fiber; 710 milligrams sodium (does not include salt to taste); 18 grams protein

Martha Rose Shulman is the author of "The Very Best of Recipes for Health."

Recipes for Health: Smoked Salmon Sandwich With Goat Cheese

Posted: 10 Aug 2011 08:49 AM PDT

At the Russ and Daughters store in Manhattan, which specializes in smoked and cured fish of all kinds, I found a goat cream cheese that inspired this sandwich.

Recipes for Health

Martha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.

Related

1 1/2 ounces smoked salmon (more if desired)

1/2 ounce goat cheese (about 2 tablespoons)

1 to 2 tablespoons plain yogurt

Several cucumber slices (about 1 1/2 ounces)

A squeeze of lemon

Salt and freshly ground pepper

Chopped chives or dill

2 slices whole-grain sandwich bread, rye bread or a heartier whole-grain country bread

1. In a bowl, mash the goat cheese with a fork. Add the yogurt, and mix together until smooth. Spread half on one slice of bread, and top with the smoked salmon. Slice the cucumbers very thin, and layer them over the salmon. If desired, season the cucumbers with a little salt and pepper, and squeeze on some lemon juice. Sprinkle the chopped chives or dill over the cucumbers.

2. Spread the remaining goat cheese mixture over the other piece of bread. Place on top of the cucumbers, press down and cut the sandwich in half.

Yield: One serving.

Advance preparation: This will keep well for a day. Wrap tightly in plastic wrap, and place in a bag. Keep cold if possible.

Nutritional information per serving: 303 calories; 5 grams saturated fat; 2 grams polyunsaturated fat; 3 grams monounsaturated fat; 55 milligrams cholesterol; 25 grams carbohydrates; 4 grams dietary fiber; 535 milligrams sodium (does not include salt to taste); 27 grams protein

Martha Rose Shulman is the author of “The Very Best of Recipes for Health.”

Recipes for Health: Sandwiches for Summer

Posted: 08 Aug 2011 02:19 PM PDT

Whenever I fly, I like to go armed with lunch, as the food in airports tends to be both appalling and expensive. Lately I’ve hitting the road with sandwiches that combine produce with canned fish, like sardines, herring, trout or smoked salmon — all of them high in omega-3 fatty acids, packed with protein and delicious.

Recipes for Health

Martha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.

In some of this week’s sandwiches, I used small whole-wheat English muffins that were lightly toasted. The muffins won’t fall apart, even with a juicy filling like Greek salad, and I like the size.

Spinach and Sardine Sandwich

This is inspired by the classic Mediterranean combination of sardines and spinach. I like to use lightly smoked sardines in olive oil for it.

2 teaspoons extra virgin olive oil

1 small garlic clove, minced

2 ounces baby spinach (2 cups tightly packed), rinsed

Salt and freshly ground pepper

1 small (3 1/2-inch) whole-wheat English muffin, lightly toasted

Dijon mustard (optional)

2 canned sardines, preferably lightly smoked in olive oil (about 2 ounces), filleted

1 small tomato, sliced (optional)

Lemon juice

About 1 teaspoon mayonnaise

1. Heat the olive oil in a medium skillet over medium heat, and add the garlic. Cook, stirring, until fragrant, about 30 seconds. Add the spinach. Turn up the heat, and wilt the spinach in the water left on the leaves after washing. Season with salt and pepper, and remove from the heat. Drain and press out excess water.

2. Lightly toast the English muffin. Spread a little mustard if desired over the bottom half and top with the spinach. Lay the sardine fillets over the spinach, and douse with a little lemon juice. If you have a nice ripe in season tomato, lay over the sardines. Spread the top half of the English muffin with mayonnaise, and top the sandwich. Press down and cut in half, or wrap and refrigerate until ready to eat.

Yield: One serving.

Advance preparation: You can wrap this tightly and keep it in the refrigerator for a day. It’ll be fine for a few hours if you take it on an airplane.

Nutritional information per serving: 366 calories; 3 grams saturated fat; 3 grams polyunsaturated fat; 9 grams monounsaturated fat; 27 milligrams cholesterol; 30 grams carbohydrates; 6 grams dietary fiber; 421 milligrams sodium (does not include salt to taste); 19 grams protein

Martha Rose Shulman is the author of “The Very Best of Recipes for Health.”

Posted by at

No comments:

Post a Comment

Subscribe to: Post Comments (Atom)

Enter your email address:

Delivered by FeedBurner