Health & Fitness (206)
WASHINGTON (AP) -- Little Amelia Sloan became a pioneer shortly after her birth.
The healthy baby is part of a large research project outside the nation's capital that is decoding the DNA of hundreds of infants. New parents in a few other cities soon can start signing up for smaller studies to explore what's called genome sequencing - fully mapping someone's genes to look for health risks - should become a part of newborn care.
It's full of ethical challenges.
Should parents be told only about childhood threats? Or would they also want to learn if their babies carried a key gene for, say, breast cancer after they're grown? Could knowing about future risks alter how a family treats an otherwise healthy youngster? And how accurate is this technology - could it raise too many false alarms?
This is the newest frontier in the genetic revolution: how early to peek into someone's DNA, and how to make use of this health forecast without causing needless worry.
"This was something that was looming over the horizon," said Dr. Alan Guttmacher, a pediatrician and geneticist who heads the National Institutes of Health's child health division. Last month, NIH announced a $25 million, five-year pilot project in four cities - Boston, San Francisco, Chapel Hill, N.C., and Kansas City, Mo. - to start answering some of the questions before the technology is widely offered for babies.
Today, the 4 million U.S. babies born annually have a heel pricked in the hospital, providing a spot of blood to be tested for signs of at least 30 rare diseases. This newborn screening catches several thousand affected babies each year in time for early treatment to prevent death, brain damage or other disabilities. It's considered one of the nation's most successful public health programs.
A complete genetic blueprint would go well beyond what that newborn blood spot currently tells doctors and parents - allowing a search for potentially hundreds of other conditions, some that arise in childhood and some later, some preventable and some not.
"If I truly believed that knowing one's genome was going to be transformative to medicine over the next decade or more, then wouldn't I want to start generating that information around the time of birth?" asked Dr. John Niederhuber, former director of the National Cancer Institute who now oversees one of the largest baby-sequencing research projects to date.
At Niederhuber's Inova Translational Medicine Institute in Falls Church, Va., researchers are mapping the genomes of newborns, along with their parents and other relatives for comparison. The long-term goal of the privately funded study is to uncover genetic patterns that predict complex health problems, from prematurity to developmental disorders.
But the experimental tests will turn up some gene mutations already well-known to cause serious ailments, and participating parents must choose upfront whether to be told. They don't get a full report card of their baby's genes. Only ones that cause treatable or preventable conditions - so-called medically actionable findings - are revealed, to the family's doctor. That means in addition to pediatric diseases, parents also could learn whether a baby carries a particular breast-cancer-causing gene, information useful once she reaches young adulthood.
Nurse Holly Sloan was eager to enroll daughter Amelia, although she thought hard about how she'd handle any bad news.
"If it was something that we could hopefully prevent through diet or exercise or some kind of lifestyle change, we could start with that as early as possible," said Sloan, of Warrenton, Va. "I guess I'm just the type of person, I would rather know and address it." Five months after Amelia's birth, she hasn't gotten any worrisome results.
Until now, genome sequencing has been used mostly in research involving curious adults or to help diagnose children or families plagued by mysterious illnesses.
But many specialists say it's almost inevitable that DNA mapping eventually will be used for healthy young children, too, maybe as an addition to traditional newborn screening for at least some tots. It takes a few drops of blood or a cheek swab. And while it's still too costly for routine use, the price is dropping rapidly. Whole genome sequencing is expected to soon come down to $1,000, what it now costs for a more targeted "exome" sequencing that maps only certain genes and may be enough.
The NIH decided this was a window of opportunity to explore different ways this technology might be used. One of the four teams - at Children's Mercy Hospital in Kansas City - will test rapid gene-mapping to speed diagnosis of sick babies in intensive care.
Another will look for narrow sets of genes important in childhood, such as those involved with immune disorders not detected by today's newborn screening or that alter how a child processes medication. "It's not going to be some sort of fishing expedition throughout the genome," said Dr. Robert Nussbaum of the University of California, San Francisco.
The two other projects - at Brigham and Women's Hospital in Boston and the University of North Carolina, Chapel Hill - will go a step further by enrolling healthy infants as they explore what kind of information parents want about their babies' future.
"We aren't even sure that genome-scale sequencing in newborns is really a good idea," cautioned UNC lead researcher Dr. Jonathan Berg in a recent Facebook chat to alert the community about the study. Rather than a one-time mapping, it's possible that "we will use targeted sequencing at certain times in a person's life, when that specific information will actually be medically useful."
For those pioneering babies whose DNA is being mapped already, researchers are "trying to figure out what is legal, versus ethical, versus good medicine" in revealing results, said geneticist Joe Vockley, Inova Translational Medicine Institute's chief science officer.
Mom and Dad may be told something their child, once grown, wishes hadn't been revealed. Other findings may be withheld now that would be good to know years later, as new treatments are developed.
"This is a living, breathing problem," Vockley said, "not a static decision that's made, and it lasts for all time."
CHICAGO (AP) - A television pitchman accused of pushing false information during his late-night infomercials could avoid jail because of the government shutdown.
The Federal Trade Commission sued Kevin Trudeau, alleging he made misleading statements about his weight-loss books. Trudeau says he's unable to pay a $37 million judgment, and the FTC wants him jailed until he proves his financial assets.
But because of the government shutdown, FTC lawyers aren't getting paid. They were expected to ask a judge during a Friday hearing in Chicago to jail Trudeau, but they requested that the hearing be indefinitely delayed.
The judge briefly jailed Trudeau last month and warned he could do it again.
Trudeau's attorney didn't return a message Thursday. A voicemail for FTC lawyers said they couldn't respond until "the government ... resumes operation."
That was putting pressure on the federal government and the states that are running their own insurance exchanges to fix the problems amid strong demand for the private insurance plans.
"I think I'm through with Hawaii Health Connector," said Richard Gamberg, 61, of Honolulu, after tweeting messages to officials and complaining to state lawmakers on Wednesday. "They've got ads in the newspaper, they've got ads on the TV — it just flabbergasts me."
He was among the would-be customers in Hawaii who were still unable to buy insurance policies online Wednesday, forcing them to turn directly to insurance companies to examine their options. In Oregon, officials said a faulty online calculator would not be fixed until late October.
The delays that continued Wednesday offered one good sign for President Barack Obama and supporters of his signature domestic policy achievement, demonstrating what appeared to be exceptionally high interest in the new system. But the problems also could dampen enthusiasm for the law as Republicans use it as a rallying cry to keep most of the federal government closed.
"It's day two of health care reform, and we have yet to have someone successfully register on the marketplace," said Matt Hadzick, manager of a Highmark retail insurance store in Allentown, Pa., where people could go to register for the online insurance marketplace. "The registration process is very slow, and at one point it just shuts down."
The sweeping changes under the Affordable Care Act include federal subsidies to make insurance more affordable for low-income consumers and preventing health insurance companies from denying coverage to people with pre-existing conditions. That will open the door for coverage to many people who have been locked out of the insurance market.
In California, home to 15 percent of the nation's uninsured, officials took down the enrollment portion of the Covered California website for emergency upgrades. It was restored at mid-morning Wednesday, and 7,770 people had started applications by then, spokesman Roy Kennedy said.
California is one of a handful of mostly Democratic states that opted to set up their own exchanges rather than let the federal government do it for them. In the 36 states being operated by the federal Department of Health and Human Services, consumer patience was being tested.
Agency spokeswoman Joanne Peters said many Americans successfully enrolled on the first day, but she declined to put a number on it. She said the delays were due to "overwhelming interest" and high volume.
The delays come three months after the congressional Government Accountability Office said a smooth and timely rollout could not be guaranteed because the online system was not fully completed or tested.
The bumpy debut has the hallmarks of a technology project that may have rushed to meet the Oct. 1 deadline, said Bill Curtis, chief scientist at CAST, a software quality analysis firm, and director of the Consortium for IT Software Quality, which develops standards.
"It almost reminded me of going online and trying to buy Springsteen tickets," said Sharon Schorr of suburban Cleveland, a self-employed accountant who finally gave up after eight hours of trying to use the exchange's website.
With websites crashing, those who have been trained to explain the benefits under the federal law were trying to reach out to those who could be helped by the exchanges, handing out information at public transit hubs and holding town hall meetings in smaller communities.
Without online access, however, they could not actually guide people through the enrollment process.
"I've been unable to get in, and if I could have that would be great," said Donene Feist, an outreach worker who also is executive director of Family Voices of North Dakota, a nonprofit advocacy group. "For those who got in, they said it was easy to follow."
The Obama administration hopes to sign up 7 million people in the first year, and eventually cover at least half of the nearly 50 million uninsured Americans through government-subsidized plans and a Medicaid expansion.
Many states expect people to sign up closer to the Dec. 15 deadline to enroll for coverage starting Jan. 1. Customers have until the end of March to sign up to avoid tax penalties.
___ Alonso-Zaldivar reported from Washington, D.C.
___ Contributing to this report were Associated Press writers Jeff Barnard in Grants Pass, Ore., Oskar Garcia in Honolulu; James MacPherson in Bismarck, N.D.; Laura Olson in Sacramento; Michael Rubinkam in Allentown, Pa.; and John Seewer in Toledo, Ohio.
The online health insurance exchanges are now open in both Missouri and Illinois. The online marketplace is a key component of the federal health care law.
Illinois officials have set up their own marketplace at GetCoveredIllinois.gov.
Missouri voters chose to bar their government from setting up its own marketplace. So the federal government is running the exchange for Missouri residents at Healthcare.gov.
Consumers have until December 15th to sign up if they want coverage to start on January 1, but enrollment is open until March 31.
Flu season is just around the corner, and now is the time to protect yourself against the disease...for free.
This weekend, Barnes Jewish Hospital will be offering free flu shots clinics.
A clinic is scheduled for 9 a.m. to 2 p.m. Saturday in North County at the Shalom Church City of Peace Health Fair.
Another is scheduled for 9 a.m. to 3 p.m. at Barnes-Jewish West County Hospital, Medical Office Building 2.
It is recommended that anyone over six month old get a flu vaccine.
Doctors often short them on chemotherapy by not basing the dose on size, as they should. They use ideal weight or cap the dose out of fear about how much treatment an obese patient can bear. Yet research shows that bigger people handle chemo better than smaller people do.
Even a little less chemo can mean worse odds of survival, and studies suggest that as many as 40 percent of obese cancer patients have been getting less than 85 percent of the right dose for their size.
Now, the largest organization of doctors who treat cancer, the American Society of Clinical Oncology, aims to change that. The group has adopted guidelines urging full, weight-based doses for the obese.
Don't call it supersizing; it's right-sizing cancer care, said Dr. Gary Lyman, a Duke University oncologist who led the panel that wrote the advice.
"There's little doubt that some degree of undertreatment is contributing to the higher mortality and recurrence rates in obese patients," he said.
The Food and Drug Administration's cancer drug chief, Dr. Richard Pazdur, agrees.
"By minimizing the dose, or capping the dose, we have been undertreating patients," he said.
The dosing issue applies to all types of cancer treated with chemo - breast, colon, lung, ovarian and even blood diseases such as leukemia.
It affects a lot of people. Big isn't healthy but it's the new "normal" - 60 percent of Americans are overweight and more than one-third of them are obese.
Giving too little chemo "could make it as if they didn't even get treated at all ... so they go through the whole ordeal with no benefit, in the extreme case ," said Dr. Jennifer Griggs, a University of Michigan breast cancer specialist who also worked on the guidelines.
So why do doctors limit dose?
Sometimes it's for good reason - the patient has diabetes, heart problems or other illnesses that interfere with how much chemo they can stand. Usually, though, it's because doctors are afraid to follow a standard weight-based formula because the dose seems so huge and they're afraid of harming the heart and blood system, Lyman said.
"You're three times the size of the average person, but it doesn't mean your heart is," Griggs explained.
Yet studies show that heavier patients are less likely to develop dangerous, low blood counts from cancer treatment, and that they clear chemo drugs more quickly from the body than thinner people do.
A paper Lyman published in the journal Nature in August said that a 20 percent reduction in chemo doses lowered remission and cure rates by half in animal experiments and helped the tumors develop resistance to the drugs. Other research in people found lower survival among those getting less chemo as well.
Even if a patient develops a problem from a chemo treatment and doctors have to dial it back, it's important to try a full dose the next time around so the patient gets all the treatment intended, Lyman said.
That happened to Tracy Smith, a 46-year-old Durham, N.C., woman treated at Duke in 2011 for breast cancer that had spread to more than a dozen lymph nodes. Doctors gave her full chemo doses based on her weight, which at 285 pounds classified her as obese.
Three times, high fevers put her in the hospital, and one treatment was cut short because doctors thought it was causing wheezing and possible lung damage. But she resumed and finished the intended treatment and has been cancer-free since then.
After hearing you have cancer, "you're just kind of in a fog" and don't think to ask about doses of the drugs you need, she said. "I trusted my doctor. Doctors should be well aware of what you can tolerate. You should do whatever you can to fight this beast."
Smith's tumor was fueled by estrogen - a hormone made in abundance by fat tissue. Robin McRath, a floral designer who helps run a women's shelter in Ludington, Mich., had the same type.
"It's like a playground, an amusement park, for cancer cells when you're fat," she said. She was only was 41 when her cancer was diagnosed five years ago, and her oncologist, Dr. Carol Peterson, treated her with full doses based on her weight - about 240 pounds, which put her in the obese category.
"We didn't discuss dosage. That didn't matter to me - I just wanted to get it out of my system," she said of the cancer, and praised the treatments to prevent one of chemo's most feared side effects. "There are fantastic anti-nausea medicines. I was never sick one day."
McRath is active in the Obesity Action Coalition, an education and advocacy group. A spokesman said the group was unaware of the dosing issue for obese patients.
Not all doctors are aware either. Luckily for McRath, hers was. Peterson said she uses full doses unless a patient has other health issues.
"If that's their only problem - if they're just overweight or obese - they can do quite well" with full weight-based doses, she said.
Duke's Lyman agreed, and offered this advice to patients: "Ask your doctor how they plan to treat you and whether you're going to get the full dosing. The doctor may have a good reason not to, but you should have that discussion."
--- AP National Writer Allen G. Breed in Raleigh, N.C., contributed to this report.
Online: Guidelines: HTTP://WWW.ASCO.ORG/GUIDELINES/WBD ---
Concerned about the nation's childhood obesity issues, the first lady on Wednesday is convening the first White House summit on food marketing to children to get involved parties talking about how to help consumers make healthier food choices. That includes enlisting the persuasive power of the multimillion-dollar food marketing industry.
As she helped kick off a nationwide campaign last week to encourage people to drink more plain water, Mrs. Obama said she would keep reaching out to new people and organizations and keep making the case for healthier choices like water and fruits and vegetables.
The White House says it has invited representatives from the food and media industries, advocates, parents, representatives of government agencies and researchers, though it did not release a list of names and organizations. Mrs. Obama will open the meeting with public remarks. The rest of the meeting will be closed to the media.
Consumer advocates say studies show that food marketing is a leading cause of obesity because it influences what children want to eat.
A 2006 report on the issue by the influential Institute of Medicine concluded that food and beverage marketing to children "represents, at best, a missed opportunity, and, at worst, a direct threat to the health of the next generation."
Improvements have come in the years since, especially after Mrs. Obama began drawing attention to childhood obesity with a campaign of her own in 2010.
She stood with the Walt Disney Co. last year when it became the first major media company to ban ads for junk food from its media channels, websites and theme parks. She also has praised the Birds Eye frozen food company for encouraging children to eat vegetables, including through promotions featuring characters from the Nickelodeon comedy "iCarly."
But the first lady and consumer advocates say more improvements are needed.
"Most of the food ads that kids see are still for unhealthy food, which makes it really hard for parents to feed their children healthfully," said Margo Wootan, a nutrition lobbyist for the consumer advocacy group Center for Science in the Public Interest. Wootan planned to attend the summit.
In a speech earlier this year to a health conference, Mrs. Obama said limiting the promotion of unhealthy food to kids isn't the only solution.
"It's also about companies realizing that marketing healthy foods can be responsible and the profitable thing to do as well," she said.
The White House summit, which consumer advocates say marks the first time the White House has focused on this issue, could pick up where Congress and the administration left off a few years ago after the administration gave up trying to get the food industry to agree to voluntary marketing guidelines.
Preliminary guidelines released in 2011 asked food companies, advertisers and TV networks only to market foods to children if they are low in fats, sugars and sodium and included specified healthy ingredients. But the effort fizzled after many Republican lawmakers sided with the food industry, which accused government of overreaching.
The companies said the guidelines were overly broad and would limit marketing of almost all of the nation's favorite foods. The food companies also said they were feared government retaliation if they didn't go along with guidelines that were intended to be voluntary.
Large food companies then announced their own guidelines that, not surprisingly, were more lenient than what the Federal Trade Commission, the Agriculture Department, the Food and Drug Administration and the Centers for Disease Control and Prevention had proposed under the direction of Congress.
The FTC publicly backed off some of the guidelines, including a recommendation that companies change packaging and remove brand characters from some foods. In late 2011, the agency said Congress "had clearly changed its mind" and said it would take another look. It never released updated guidelines.
New York University food and nutrition professor Marion Nestle, who also was attending the meeting, said studies show that voluntary restrictions don't work.
"Food marketing is the elephant in the room," she said. "If you're serious about childhood obesity, you've got to do something about food marketing." ---
Associated Press writer Mary Clare Jalonick contributed to this report. ---