Monday, November 7, 2011

Babies on obesity path? New sign may offer answer (AP)

CHICAGO � Researchers say there's a new way to tell if infants are likely to become obese later on: Check to see if they've passed two key milestones on doctors' growth charts by age 2.

Babies who grew that quickly face double the risk of being obese at age 5, compared with peers who grew more slowly, their study found. Rapid growers were also more likely to be obese at age 10, and infants whose chart numbers climbed that much during their first 6 months faced the greatest risks.

That kind of rapid growth should be a red flag to doctors, and a sign to parents that babies might be overfed or spending too much time in strollers and not enough crawling around, said pediatrician Dr. Elsie Taveras, the study's lead author and an obesity researcher at Harvard Medical School.

Contrary to the idea that chubby babies are the picture of health, the study bolsters evidence that "bigger is not better" in infants, she said.

But skeptics say not so fast. Babies often grow in spurts and flagging the speediest growers could lead to putting infants on diets � a bad idea that could backfire in the long run, said Dr. Michelle Lampl, director of Emory University's Center for the Study of Human Health.

"It reads like a very handy rule and sounds like it would be very useful � and that's my concern," Lampl said. The guide would be easy to use to justify feeding infants less and to unfairly label them as fat. It could also prompt feeding patterns that could lead to obesity later, she said.

Lampl noted that many infants studied crossed at least two key points on growth charts; yet only 12 percent were obese at age 5 and slightly more at age 10. Nationally, about 10 percent of preschool-aged children are obese, versus about 19 percent of those aged 6 to 11.

Lampl and Edward Frongillo, an infant growth specialist at the University of South Carolina, voiced concern in an editorial accompanying the study in the journal Archives of Pediatrics & Adolescent Medicine, released online Monday. They argue that more research is needed to confirm whether the study's recommendation is really a useful way to flag infants for obesity.

"The potential to do more harm than good is actually very high," Frongillo said.

Taveras said the kind of rapid growth noted in the study should be used to raise awareness about potential risks but is not a reason to put babies on a diet.

The study involved 45,000 infants and children younger than age 11 who had routine growth measurements during doctor checkups in the Boston area from 1980 through 2008.

Growth charts help pediatricians plot weight, length in babies and height in older kids in relation to other children their same age and sex. Pediatricians sometimes combine an infant's measures to calculate weight-for-length � the equivalent of body-mass index, or BMI, a height-to-weight ratio used in older children and adults.

The charts are organized into percentiles. For example, infants at the 75th percentile for weight are heavier than 75 percent of their peers.

The study authors used seven major cutoffs on the charts � the 5th, 10th, 25th, 50th, 75th, 90th and 95th percentiles � to calculate growth pace. An infant whose weight-for-length jumped from the 19th percentile at 1 month to the 77th at 6 months crossed three major percentiles � the 25th, 50th and 75th � and would be at risk for obesity later in childhood, the authors said.

Larger infants were most at risk for obesity later on, but even smaller babies whose growth crossed at least two percentiles were at greater risk than those who grew more slowly.

About 40 percent of infants crossed at least two percentiles by age 6 months. An analysis of more than one-third of the study children found that 64 percent grew that rapidly by age 2.

Dr. Joanna Lewis, a pediatrician at Advocate Lutheran General Hospital in Park Ridge, Ill., said she supports the idea that infancy is not too young to start thinking about obesity.

Still, she emphasized that rapid growth in infancy doesn't mean babies are doomed to become obese. "It's not a life sentence," and there are steps parents can take to keep their babies at a healthy weight without restrictive diets, she said.

Lewis said many of her patients are large babies whose parents feed them juice or solid food despite guidelines recommending nothing but breast milk or formula in the first six months.

"The study reinforces what we try to tell parents already: Delay starting solids and don't put juice in a bottle," Lewis said.

Lewis also advises parents that when starting infants on solid food, have the whole family sit down and eat together. Research has shown that obesity is less common in children raised in families that have frequent meals together at home.

___

Online:

Journal: http://www.archpediatrics.com

Growth charts: http://www.cdc.gov/growthcharts

___

AP Medical Writer Lindsey Tanner can be reached at http://www.twitter.com/LindseyTanner



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Hit reset on cancer screening: 'Tests not perfect' (AP)

WASHINGTON � It turns out that catching cancer early isn't always as important as we thought.

Some tumors are too slow-growing to ever threaten your life. Some are so aggressive that finding them early doesn't make much difference. And today's treatments are much better for those somewhere in the middle.

Those complexities are changing the longtime mantra that cancer screening will save your life. In reality, it depends on the type of cancer, the test and who gets checked when.

"We can find cancer early. We can reduce the burden of the disease. But along the way, we're learning our tests are not as perfect as we'd like," says the American Cancer Society's Dr. Len Lichtenfeld, a longtime screening proponent. "We're learning that we're now finding cancer that would in fact never cause harm."

Now cancer specialists are struggling to find a new balance: to quit over-promising the power of early detection and to help people understand that the tests themselves have risks � while not scaring away those who really need it.

Least controversial are cervical and colorectal cancer screenings. They can spot pre-cancerous growths that are fairly easy to remove, although even some of those tests can be used too frequently. More serious questions surround other cancers � like which men, if any, should get a PSA blood test to check for prostate cancer, and whether women should start mammograms in their 40s or wait until they're 50.

Also in question is whether doctors will be able to head off another looming controversy: Just which smokers and ex-smokers should get a pricey CT scan that can detect lung cancer but also is prone to false alarms? A recent study found the scans could save some lives. But guidelines aren't due out until early next year that would decide who is at enough risk to outweigh the test's potential harm � such as a risky, invasive biopsy to tell if a suspicious spot is cancer or just an old smoking scar.

Yet already people like 80-year-old Fred Voss of Sunderland, Md., are seeking out the tests.

"It was a big relief, and it gave me something to watch," says Voss, who participated in the CT study but wanted to get tested again to make sure nothing had changed.

Today, guidelines for how to handle some of the most common cancer screenings conflict. And, they're written for the average patient when many people may need a more customized decision, says Dr. Jeanne Mandelblatt of Georgetown University. She has studied breast cancer risk for a government panel that recommends most women not begin screening for the disease until age 50.

Consider this, she says: The average woman has a 3 percent lifetime risk of dying of breast cancer, a low risk for a disease that women find so scary. But the chances of getting breast cancer do gradually increase with age and other circumstances.

So if you're 40 and have several risk factors � like dense breasts and close relatives with the disease � then you have the same risk as an average 50-year-old, not an average 40-year-old, and might consider earlier mammograms, Mandelblatt says. Few primary-care doctors have the time to go into that kind of detail.

Adding to the confusion are testimonials from cancer survivors that a screening saved their lives. Dartmouth researchers recently studied how often that's true for mammograms, and estimated that about 13 percent of women in their 50s whose breast cancer is detected by the tests survive as a result.

What else plays a role? Treatments have dramatically improved in recent years, saving more lives. Also, increasingly powerful mammograms are detecting more low-risk tumors, the kind that probably wouldn't have threatened a woman's life in the first place.

Still, mammograms are "not perfect, but they're the best we have," cautions Mandelblatt. She thinks the Dartmouth estimate is somewhat low.

PSA tests for prostate cancer are a much tougher call. Last month, a government panel recommended an end to routine PSA screenings, a step further than other major medical groups that urge men to weigh the pros and cons and decide for themselves. But the U.S. Preventive Services Task Force found limited, if any, evidence that screening average men improves survival. That's largely because so many men are diagnosed with slow-growing tumors that never would have killed them; still, they have treatments that can cause incontinence, impotence or even lead to death.

"We really � underline the word `really' � have to pull back the messaging on prostate cancer," says the cancer society's Lichtenfeld, who himself isn't sure of the test's net worth. PSA testing took off on the basis of "blind faith" that they would work, not science, he says.

What really worries Lichtenfeld is that ever more powerful cancer screenings are being developed, before doctors have a way to tell exactly which early tumors should be removed.

"We have cells in our body that are abnormal all the time, and our bodies deal with it," he says. "Our technology takes us further and further down the early-detection path, and we need to sort through all this."

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EDITOR'S NOTE � Lauran Neergaard covers health and medical issues for The Associated Press.



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Friday, November 4, 2011

Too posh to push? More C-sections on demand in UK (AP)

LONDON � Pregnant women in Britain, where the government provides free health care, may soon be able to get a cesarean section on demand thanks to a rule change that critics describe as the health system caving into the "too posh to push" crowd.

Currently, British women who can't afford to pay private doctors for their baby's delivery have been allowed to have planned C-sections only if there are health concerns for mother or baby. Emergency C-sections are done when the situation demands it.

But new guidelines set to take effect later this month say pregnant women "with no identifiable reason" should be allowed a cesarean if they still want it following a discussion with mental health experts.

"It's about time women who have no desire to view labor as a rite of passage into motherhood be able to choose how they want to have their baby," said Pauline Hull, who has had two children by cesarean because of medical reasons. "The important thing to me was meeting my baby, not the experience of labor."

Hull runs a website about elective C-sections from her home in Surrey, south of London. She said doctors tend to overexaggerate the risks of C-sections and underestimate those of vaginal births.

The new draft guidelines come from the National Institute for Health and Clinical Excellence, or NICE. The agency's guidelines are usually accepted by the government and determine what will be paid for by its health system.

"In general, a C-section is a safe operation, especially when performed as a planned procedure," the new guidance says.

The agency says it routinely updates guidance every few years and denies there was any pressure to change its more restrictive C-section advice. But in recent years, advocates and some doctors have slammed the U.K. health system for not giving women a greater say in childbirth.

The change comes at a price for Britain's cash-strapped health system. NICE estimates C-sections cost about 800 pounds ($1,280) more than a vaginal birth, although that doesn't include the price of treating possible long-term complications like urinary incontinence from vaginal births.

The report notes that for every percentage point the C-section rate falls, the health system could save 5.6 billion pounds ($8.9 billion).

In the U.K., about 25 percent of women have C-sections, versus about 30 percent in the U.S. In both countries, rates have doubled in recent years, though doctors say that's not just due to demand, but because pregnant women increasingly have other problems like obesity and diabetes.

About 10 percent of all U.K. births are planned C-sections while about 15 percent are emergency procedures, according to NHS figures.

The World Health Organization says wealthy countries should aim for a C-section rate of about 15 percent.

The National Health Service estimates that about 15 percent of British births take place in private hospitals, which tend to have higher cesarean rates. At Portland Hospital in London, where many celebrities check in, the C-section rate ranges from 35 to 40 percent.

The issue of women having C-sections on demand has long been a hot button issue in the U.K., with celebrities like Madonna and former Spice Girl Victoria Beckham having scheduled procedures at upscale hospitals. Criticism for the wealthy getting these elective surgeries led to the phrase "too posh to push."

But some experts say the new British guidance won't dramatically change how pregnant women are treated.

"It's only a small percentage of women who ask for a C-section," said Cathy Warwick, chief executive of the Royal College of Midwives.

Warwick said doctors and midwives regularly talk to women who have concerns about childbirth and after addressing their fears, most women agree to skip a planned C-section.

"As long as it's safe for both mother and baby, a vaginal birth is absolutely the best way for anyone to deliver," said Dr. Daghni Rajasingham, an obstetrician and spokeswoman for the Royal College of Obstetricians and Gynaecologists. She said the physical stress put on a baby's lungs during labor helps them adapt to breathing after being born.

Rajasingham also said while C-sections are safe, the operation comes with risks including infections, bleeding, and the potential for problems with future pregnancies.

"As an obstetrician working with limited resources, I want to make sure we have safe and high-quality health care for all women and not be skewed by a few women who want something specifically," Rajasingham said.

For women like Hull, however, the policy shift is long overdue.

"Women shouldn't think a C-section is going to be a walk in the park, but they should have all the information they need to help them make an informed choice," she said.



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Texas board mulls stem cell therapy used on Perry (AP)

AUSTIN, Texas � The experimental stem cell procedure that Texas Gov. Rick Perry underwent this summer could be restricted or even blocked under new rules being considered Friday by the state's Medical Board.

Some top scientists are questioning the safety and wisdom of the procedure, and doctors say it may run up against federal rules. It also carries potential health threats, ranging from blood clots to increased cancer risk.

The Republican presidential candidate had stem cells taken from fat in his own body, which were then grown in a lab. They were injected into his back and his bloodstream during an operation in July to fuse part of his spine.

Adult stem cells have long been used to treat leukemia, lymphoma and other cancers. While the cells are being studied to treat other ailments, from heart disease to diabetes, experts say it's too soon to know if the approaches are safe or effective. The Food and Drug Administration hasn't approved using adult stem cells to help people heal from surgery � but experimentation is common.

Perry opposes greater oversight in Texas, and he sent a letter to the board urging members to recognize the "revolutionary potential" of adult stem cell research and therapies.

"Texas is a leader in innovation in many fields," Perry wrote after his surgery. "It is critical that we continue to foster an environment that encourages technological advancement in the health care arena."

Adult stem cell therapy is different from using embryonic cells, a controversial technology that Perry opposes.

The medical board will meet Friday to discuss rules that would require an accredited body to review any procedures involving stem cells before they're carried out, to access research trials and ensure patient safety. The rules also would require that such therapies be done by physicians and in adherence to Texas and federal laws.

The 19 volunteer board members � all appointed by Perry, including a dozen physicians � could approve the proposed rules, make or seek changes, or scrap them altogether, board spokeswoman Leigh Hopper said.

If the board vote goes against him, the matter could become a campaign issue as Perry struggles to reinvigorate his White House bid. His polling numbers have tumbled in recent weeks. Perry has worn a back brace but maintained his work schedule since the surgery.

Some orthopedic surgeons are experimenting with stem cells to help bones heal, with the cells being taken from bone marrow and injected or implanted in the trouble spot. The theory is that such "master cells" will follow cues from cells around them and form bone or cartilage, though researchers worry they also might spur unwanted growth and cancer.

Perry's treatment, which involved using stem cells from fat, was even more experimental.

Perry said in his letter that he understood the need to protect patients, but added, "we need to ensure that physicians in this state can continue to pursue new technologies and treatments that will benefit all Texans."



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Thursday, November 3, 2011

Study: Infant formula ads reduce breast-feeding (AP)

MANILA, Philippines � The World Health Organization said a study has found that Filipino mothers who have been influenced by advertisements or their doctors to use infant formula are two to four times more likely to feed their babies with those products.

The study appears to support the Philippines' decision to limit advertising for infant formula, which can discourage mothers from breast-feeding that provides health benefits for newborns.

Published by the Social Science and Medicine Journal in September and released this week, the study said those mothers were 6.4 times more likely to stop breast-feeding babies within one year of age � a step that raises risks of illness and death for the infant.

Breast milk significantly reduces infant mortality, according to international health experts, who recommend that mothers exclusively breast-feed for the first six months and continue breast-feeding, supplemented by solid foods, until their babies are 2 years old.

The International Code of Marketing of Breast-Milk Substitutes, sponsored by the World Health Organization and UNICEF, is not legally binding. It is up to individual countries to implement the code by enacting their own laws.

The Philippine study wanted to examine if marketing for breast milk substitutes was to blame for a drop in breast-feeding in the Southeast Asian country, one of several where multinational companies fought a legal battle for the right to aggressively sell baby formulas.

When the Philippine government tried to tighten its advertising laws for milk products, the companies took it to court.

The Supreme Court ruling in October 2007 upheld the Department of Health's mandate to regulate advertising of breast milk substitutes. It prohibited all health and nutrition claims but failed to support a full advertising ban, citing freedom of speech.

WHO data show exclusive breast-feeding rates for Filipino babies up to four months old dropped from 47.3 percent in 1998 to 40.1 percent in 2008.

Four of the six authors of the study are from the WHO, led by the organization's medical officer Howard Sobel. They conducted a household survey between April and December 2006 and focus groups in April-May 2007.

According to their findings, 59.1 percent of the mothers recalled an infant formula advertisement message and one-sixth reported a doctor recommended using formula. Those who recalled an ad message were twice as likely to feed their babies infant formula, while whose advised by a doctor where four times as likely to do so.

"Despite poverty and extra strain on household income associated with formula use, 41.1 percent of the infants and young children were fed formula," the authors said.

The WHO says addition of formula leads to decreased stimulation from suckling and its reflex for breast milk production. Not breast-feeding also was associated with a 5.8 times increased risk of all-cause deaths in the first two months of life, with risks elevated up to the second year, it says.

The authors said that despite the WHO's adoption in 1981 of the International Code of Marketing Breast Milk Substitutes to curtail unethical marketing promotions, few countries have fully implemented the code's ban on advertising or other forms of promotion.

Alex V. Castro III, executive director of the Infant Pediatric Nutrition Association of the Philippines that groups infant formula makers, said the association fully supports breast-feeding.

He said their members have been diligently complying with the Philippines' adaptation of the WHO's milk code, including prohibitions in advertising. He said no advertisement has been allowed without approval of an interagency headed by the Department of Health.



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Wednesday, November 2, 2011

New device uses light to screen for melanoma (AP)

WASHINGTON � Dermatologists will soon get some high-tech help deciding which suspicious-looking moles should be removed and checked for melanoma, the deadliest form of skin cancer.

The Food and Drug Administration on Wednesday approved a first-of-its-kind device, called MelaFind, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of cancer, offering a sort of second opinion to doctors. The device is approved only for dermatologists and only for use on growths that don't have obvious signs of cancer but still have one or two worrisome traits.

The hope is to find more melanomas sooner. Nearly all patients diagnosed with early-stage melanoma can be treated and cured, but 85 percent of patients with late-stage melanoma die from it within five years.

More than 70,000 people in the U.S. will be diagnosed with melanoma this year, and 16 percent are diagnosed only after the disease has spread to other parts of the body, according to estimates from the National Institutes of Health.

To diagnose the disease, doctors decide which moles to remove and biopsy using an entirely visual set of guidelines involving size, shape and color. Most dermatologists easily spot late-stage lesions that have obvious signs of cancer, including irregular edges, uneven color and a width greater than 6 millimeters. But many others are tough calls.

"Every day patients come in with 20 moles on their back and the dilemma is, which ones are suspicious and need to be biopsied?" said Dr. David Pariser, former president of the American Academy of Dermatology. "The diagnosis of melanoma is the most serious one a dermatologist makes, and we have sleepless nights worrying about it," said Pariser, who consulted for the device's maker, Mela Sciences Inc. of Irvington, on its presentation to FDA.

The device's handheld attachment, about the size of a blow dryer, emits light that penetrates below the surface of the skin, taking multicolored images that reflect the depth and shape of skin growths. A computer compares these to a database of 10,000 archived images and recommends whether a biopsy should be done.

In a company-sponsored study published last year involving around 1,300 patients, some with multiple growths, doctors reported that MelaFind correctly suggested biopsies on 125 of 127 melanomas that doctors had removed. However, the device did not raise an alarm about non-melanoma growths only about 10 percent of the time; that was still better than doctors in the study who correctly ruled out melanoma in less than 4 percent of such cases, on average. The study was published in the Archives of Dermatology.

The company's study was not intended to show that screening with the device saves lives, only that it can help improve a doctor's ability to spot melanoma.

For now, experts say MelaFind will help dermatologists make better decisions on which moles to remove.

"There is no such thing as 100 percent certainty in medicine," said Dr. George Elias, a melanoma expert at Georgetown's Lombardi Comprehensive Cancer Center who had no ties to the company or the device. "Ultimately it's the responsibility of the dermatologist to use his clinical judgment to make the best decision. This machine is there to help him, not replace him."

Elias voted with the majority of an FDA panel that narrowly endorsed the device last year.

Dermatologists say it's too early to tell whether MelaFind will lead to fewer unnecessary biopsies.

"A biopsy takes a few minutes in my hands, so if there's an issue with any lesion we will always biopsy, whether we have a MelaFind picture or not," said Dr. Leonard Goldberg, a dermatologist at the Texas Medical Center and vice president of the Skin Cancer Foundation, a disease awareness group that accepts donations from makers of sunscreen.

MelaFind underwent a contentious, years-long review by the Food and Drug Administration, which initially rejected the device and concluded it could "potentially cause more harm than good."

Regulators worried that the device could give physicians a false sense of certainty, leading to fewer biopsies. Another concern was that doctors could misinterpret the device's feedback, particularly error messages when a mole cannot be scanned. About 8 percent of growths scanned in the company study came back as "unevaluable."

At a meeting last fall, FDA scientists said Mela Sciences had not shown how its device would influence day-to-day decisions by doctors. The agency also worried about its use by general doctors not accustomed to identifying suspicious skin moles. Despite these concerns, the panel of advisers narrowly backed the overall safety and efficacy of the device in a 8-7 vote.

Regulators said this week that they ultimately approved the device after Mela Sciences agreed to limit its use to board-certified dermatologists who undergo a specialized training course.

"The device is only good for certain lesions, and that's why you have to be a dermatologist to be able to classify and categorize those lesions appropriately," said Christy Foreman, director of FDA's Office of Device Evaluation.

Foreman said an FDA-required follow-up study would help determine how much of a benefit MelaFind represents for patients.

"This device represents new technology. At the end of the day I don't know that this will be the best technology out there, but it is a step forward to allow continued innovation in this area," Foreman said.

But don't expect to see a MelaFind machine at your next doctor's appointment. The company plans a limited rollout next year of just 200 dermatologists on the East coast, all of whom must undergo company training before they can begin using the device.

Doctors will pay a one-time fee of $7,500 to lease and receive training on the device. Patients will pay $150 out of pocket for a MelaFind scan, which analysts say may limit use to more affluent patients who are willing to pay extra for the latest medical care. Mela Sciences does not plan to ask insurers to cover the device until several years from now, after it is more widely used.

MELA Sciences originally developed the technology to guide military weapons systems. But the company changed course in the mid-90s after consulting with dermatologists, adapting its technology for melanoma detection.

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AP Chief Medical Writer Marilynn Marchione contributed to this report.



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