MONDAY, MAY 7, 2012
H E A LT H & S C I E NC E
Study ties fertility treatment and birth defect risk Test-tube babies have higher rates of birth defects, and doctors have long wondered: Is it because of certain fertility treatments or infertility itself? A large new study from Australia suggests both may play a role. Compared to those conceived naturally, babies that resulted from simple IVF, or in vitro fertilization - mixing eggs and sperm in a lab dish - had no greater risk of birth defects once factors such as the mom’s age and smok ing were taken into account. However, birth defects were more common if treatment included injecting a single sperm into an egg, which is done in many cases these days, especially if male infer tility is involved. About 10 percent of babies born this way had birth defects versus 6 percent of those conceived naturally, the study found. It could be that the extra jostling of egg and sperm does damage. Or that other problems lurk in the genes of sperm so defective they must be forced to fertilize an egg. “I don’t want to scare people,” because the vast majority of babies are born healthy, said the study’s leader, Michael Davies of the University of Adelaide in Australia. Couples could use simple IVF without sperm injection, freeze the embryos and implant only one or two at a time, he said. All of those can cut the chance of a birth defect. The study was published online Saturday by the New England Journal of Medicine and presented at a fertility conference in Barcelona, Spain. Health agencies in Australia paid for the research. More than 3.7 million babies are born each year through assisted reproduction. Methods include everything from drugs to coax the ovaries to make eggs to artificial insemination and IVF. Fer tility treatments account for about 4 percent of births in Australia and as many as 8 percent of them in Denmark, where costs are widely covered, Davies said. In the United States, more than 60,000 babies were born in 2009 from 146,000 IVF attempts. About three-quarters of them used ICSI, or intracytoplasmic sperm injection. ICSI was developed because of male infertility. But half the time, it was not done for that reason but to improve the odds that at least some embryos will be created from an IVF attempt. Many clinics do it in all cases. IVF costs around $10,000 to $12,000 per attempt and another $2,000 for
sperm injection. The study used records on nearly 303,000 babies conceived naturally and 6,163 conceived with help in Australia from 1986 through 2002, plus records on bir th defects detected by age 5. Researchers counted heart, spinal or urinary tract defects, limb abnormalities and problems such as cleft palate or lip, but not minor defects unless they needed treatment or were disfiguring. They looked at birth defect rates according to type of fertility treatment. They also had three comparison groups of women who conceived naturally, including some with some history of infertility or who previously needed help to get pregnant. Among fertility treatments, only ICSI, the sperm injection, resulted in higher rates of birth defects once other factors that affect these odds were taken into account. “They take a sperm that is probably not normal and force it to conceive,” said Dr. Darine El-Chaar, an OB-GYN at Canada’s University of Ottawa. She led a smaller previous study of this and called the new work impressive and “the study that needed to be done” to sort out the source of these risks. In the study, frozen embryos were less likely to result in birth defects than fresh ones used soon after they were created. Defective ones may be less likely to survive freezing and thawing, so the fittest embryos result in pregnancies, Davies said. Babies born to women with a history of infertility who ended up conceiving on their own, or who had natural pregnancies after assisted ones, also had higher rates of birth defects. That suggests that infertility itself is playing a role. Dr Glenn Schattman, president of the Society for Assisted Reproductive Technologies and a Cornell University fertility specialist, said it was reassuring that ordinary IVF is safe. If ICSI is chosen because male infertility is involved, “parents have to be aware that by having a child with their own genetic material, they might be increasing their risk” of a birth defect, he said. Dr. Joe Leigh Simpson, a geneticist and research chief at the March of Dimes, said doctors should take this work seriously and discuss it with patients. He said techniques have improved over the last decade and ICSI may be safer now than when this study began. Even with genetic testing for various diseases, “we always tell our patients that this doesn’t guarantee a perfect baby,” he said. — AP
Clara Beatty, 9, looks at her mother while doing homework at their Winnetka, Illinois home. The fourth-grader was born with facial deformities, including underdeveloped cheekbones and a small jaw, caused by a genetic mutation called Treacher Collins syndrome. Her parents discovered Clara was quite able to cope, sometimes better than they. — AP
Girl with deformed face learns to navigate world Genetic mutation causes Treacher Collins syndrome WINNETKA, Illinois: What if you knew, even before your child was born, that she wouldn’t look like everyone else? Clara Beatty’s parents knew. They were living in Belgium at the time, a decade ago. Prenatal screening was extensive, probably more than would have been done in the United States. Those tests determined that baby Clara, their third child, was likely to be a perfectly normal kid inside. But even in the womb, doctors could see severe facial deformities - droopy eyes, under-developed cheekbones and a tiny jaw. It meant she’d need a tube in her neck to help her breathe after birth. The lack of an outer ear and restricted ear canals also would mean she’d have hearing aids by the time she was 6 months old. In Belgium, it was unusual for babies to be born with Treacher Collins syndrome, caused by a genetic mutation. Parents almost always opted to abort, doctors said. But the Beattys wouldn’t hear of it. It wasn’t any big moral statement, they say. “There was just no question,” Janet Beatty says. No wavering, despite the looks of disapproval from the medical staff before she was born and even after, in the intensive care unit. “It was kind of strange sometimes . with the doctors, some of whom I think really, really questioned why we had this baby,” says Eric Beatty, Clara’s dad. The next few years would be so challenging that the family moved back to the United States, both for family support and to seek medical care at Chicago’s Children’s Memorial Hospital and other institutions. There were breathing and feeding issues. The family had 24-hour nursing care for the first three years of Clara’s life because she vomited so frequently. They were lucky, they realized, to have that kind of help. Still, it took a toll on Clara’s parents, especially her mom. Janet Beatty just wanted her daughter to be OK physically, to not be constantly worried that she might stop breathing, or choke.
She wanted her daughter to have the happy childhood that her other two children had had free from the physical challenges and, yes, free from the constant stares of strangers when they were out in public. “Make her normal,” her mother, Janet Beatty, thought privately. “I want that normal kid. I didn’t want people to stare, and I didn’t want people running away from her.” Cosmetic surgery was an option. But on a child so young, it would have to be redone, over and over. It was better, doctors said, to wait until her teen years. And as her parents discovered, Clara was quite able to cope, sometimes better than they. Even today, Janet Beatty is astounded at how well her youngest daughter navigates the world. “Even when she was little, you could look at her and people would say there’s an old soul in there,” she says. “She just had these big eyes and you could see her taking everything in.” Certainly, there are times when Clara gets frustrated. Now 9 years old and finishing the fourth grade, she looks forward to the day a few years from now when her skull will have grown enough for cosmetic surgery. It won’t “fix” things, but likely will help her blend more - and possibly help her get rid of the breathing tube. “I want to try to make myself as much like the other kids, so that I can stop having everyone asking me questions,” Clara says, “because it gets so annoying.” She says it matter-of-factly - not like she’s hurt or damaged by the questions and comments. When people stare, she says, she just “smiles and says ‘hi,’” because that’s what her parents have taught her to do. It’s easiest, of course, when she’s in her “protective bubble,” as her mom calls it - at home or school or church. There, people know her. To them, she is just Clara - the funny, kind girl who
FDA for ‘judicious’ antibiotic use on farms After decades of debate, federal regulators have condemned the practice of using antibiotics on healthy farm animals, trying to stem the rise in socalled “superbugs” that pose a dire threat to human health. The new guidelines from the Food and Drug Administration, which are voluntary, advise the agricultural industry to use antibiotics “judiciously” in treating and preventing sickness, and recommend that veterinarians oversee usage. The new stance follows studies by scientists and the FDA from the 1970s, which showed that antibiotics given on farms lead to drug-resistant bacteria-the superbugs-that can spread to humans. In the past several decades, health care professionals as well as veterinarians have seen a steep rise in drug-resistant infections. Just one of the types of resistant bacteria, Methicillin-resistant Staphylococcus aureus (MRSA), found in both farms and hospitals, has been estimated to kill more people than AIDS, according to the Centers for Disease Control and Prevention. MRSA has also been found on packaged meat in grocery store shelves. While many scientists and the American Veterinary Medical Association laud the FDA’s move, state ranchers and dairy farmers fear they’re headed down a trail of over-regulation that would stymie the health care of their animals. Meanwhile, public interest groups, including the Natural Resources Defense Council, say the guidelines are simply not strong enough. The FDA is giving the industry three years to adopt the guidelines before it determines the next step, which could be to make the rules mandatory.
“Antibiotic resistance has increased tremendously over the last several decades,” said Dr. Stuart Levy, an expert on the issue. The situation is critical, he added, because the resistant bacteria travel with food products from the farm to home. A 2010 report by the CDC found an alarming amount of superbugs in grocery stores. More than half of all ground turkey carried E. coli that was resistant to three or more drugs. E. coli causes gastrointestinal infections and sickens about 265,000 people each year, according to the CDC. Similarly, half of all packaged pork chops were contaminated with multi-drug resistant salmonella, another cause of gastrointestinal illnesses that sickens 1.2 million people each year and results in almost 500 deaths. In a separate study published earlier this year, Iowa researchers found that nearly 7 percent of packaged pork products carried MRSA-even meat labeled “antibiotic free.” Most food experts do say that the new guidelines will have little, if any, impact on grocery prices-even if they’re made mandatory. Farmers learned in the 1950s that if they gave healthy animals food with a dash of antibiotics-less than the dose used to treat an illness-the animals would grow bigger and need less food. And nearly all of the antibiotics were available over-the-counter. However, that also created perfect conditions for generating superbugs, according to numerous studies. In a 1976 study, a team of researchers, led by Levy, fed chickens low doses of the antibiotic tetracycline-a drug also used in humans for a wide
variety of infections including sexually transmitted diseases and acne. Within a week, the birds had tetracycline-resistant bacteria in their intestines. In less than six months, farmworkers and neighbors had spikes in tetracycline-resistant bacteria in their fecal samples. But, some agricultural experts claim that published data regarding antibiotic use on farms is often contradictory. Dr. Michael Payne, a food safety expert at UC Davis, pointed to a 2002 USDA study that indicated that low-doses of antibiotics in turkeys knocked down salmonella levels, which commonly causes intestinal infections in people. But the study didn’t address resistance levels. “Antibiotic resistance is perhaps the most complex issue facing agriculture today,” said Payne. Despite the worrisome 1976 findings, the FDA didn’t change the rules for antibiotic use on farms. “We think basically that the FDA has caved to the agricultural industry,” said Avinash Kar, a staff attorney for the NRDC. The organization was one of several public interest groups that sued the FDA last May to press for strict rules on antibiotic usage on farms. The FDA produced the new voluntary guidelines independently from the lawsuit. But a federal judge ruled last month that the FDA must act on the issue, and that the new guidelines would not excuse the FDA from reviewing its approval of antibiotics used on healthy animals. Legal proceedings are under way to determine the next step. The food safety director of one of the groups, The Center for Science in the Public Interest, called the new guidelines “tragically flawed.”—MCT
Peru health alert after pelican deaths LIMA: Peru’s government declared a health alert along its northern coastline on Saturday and urged residents and tourists to stay away from long stretches of beach, as it investigates the unexplained deaths of hundreds of dolphins and pelicans. At least 1,200 birds, mostly pelicans, washed up dead along a stretch of Peru’s northern Pacific coastline in recent weeks, health officials said, after an estimated 800 dolphins died in the same area in recent months. The Health Ministry recommended staying away from beaches, although it stopped short of a ban, and called on health officials to use gloves, masks and other protective gear when collecting dead birds. The peak tourism season around Lima’s beaches is over, although many surfers are still venturing into the waters near the capital. The Agriculture Ministry said preliminary tests on some dead pelicans pointed to malnourishment. Oscar Dominguez, head of the ministry’s health department, said experts had ruled out bird flu. “The Health Ministry ... calls on the population to abstain from going to the beaches until the health alert is lifted,” the ministry said in a statement on its website, along with a photograph of a dead pelican. The ministry said officials had so far checked 18 beaches in and around Lima for dead birds,
but gave no details on any findings. “We’re starting from the hypothesis that it’s because the birds are young and unable to find enough food for themselves, and also because the sea temperature has risen and anchovies have moved elsewhere,” said Deputy Agriculture Minister Juan Rheineck. A mass pelican death along Peru’s northern
coast in 1997 was blamed at the time on a shortage of feeder anchovies due to the El Nino weather phenomenon. Some were undeterred by the mysterious deaths. “We eat fresh fish on the quay of Chorrillos every day, and no fisherman has died yet, so don’t worry, it’s nothing,” said Gloria Rivera, a seafood restaurant owner. — Reuters
At least 1,200 birds, mostly pelicans, washed up dead along a stretch of Peru’s northern Pacific coastline in recent weeks, health officials said.
wants to be a doctor when she grows up, who’s quick to help classmates with homework when she finishes her own. She also volunteers as a mentor at the Special Gifts Theatre, an acting troupe for children with special needs. One cognitively impaired girl needed help with her lines. “It’s fun,” Clara says, “to help someone and give them a better chance at life.” People often assume that Clara can’t speak or understand them. Her classmates at school, however, are perplexed that a reporter would be doing a story about her. “Why?” one asks. “Because Clara is awesome!” another quickly replies. The support is heartening, her parents say. This is what they hoped for their daughter, that she would be accepted, welladjusted and confident - though they also know that she has many challenges. When she goes to middle school next year, there will be new people to meet, new adjustments. Same with high school, college, dating. Doctors have told her parents that Clara is more likely to worry about her appearance when she reaches adolescence. “Those are hard things to think about in a world where your physical presence, the way you look, is so much a part of society and how people react,” says Eric Beatty, vice president of a manufacturing company. “But as any parent will know, you just get on with life.” Clara - the girl with big, brown eyes and an easy smile - has helped them truly learn how to do that. “We’re all learning that we’re just going to do what we’re going to do, and we’re not going to pay attention to what other people think,” Janet Beatty says. Still, the urge to protect will always be there. “I just don’t want her spirit to ever be crushed so much that she can’t recover,” she adds. “That’s why it’s good that she has the thick skin. I just want to keep it thick. “She needs it.” — AP
Feds to put up $1.9bn for Oregon health overhaul PORTLAND, Oregon: The Obama administration is buying into an ambitious healthcare initiative in Oregon, it has tentatively agreed to chip in $1.9 billion over five years to help get the program off the ground. Oregon hopes to prove that states can save billions on Medicaid without sacrificing the quality of health care. Gov John Kitzhaber’s plan would invest in preventive care to keep patients healthy so they don’t need expensive hospitalizations. “If this works, I think other states are going to be looking at this as a way to manage that patient population,” said Kitzhaber, a Democrat and former emergency room physician who has worked for decades on reforming the health care system. The federal government could save $1.5 trillion over the next 10 years if all 50 states adopted Oregon’s approach, the governor has said. Medicaid, which provides health coverage for low-income Americans, is jointly funded by the state and federal governments. Federal officials have not yet agreed to grant Oregon a waiver from standard Medicaid regulations, which is needed for the program to be implemented and the money to be spent. The financial commitment from the US Department of Health and Human Services, while still not final, is a clear public endorsement of the concept and an indication that the administration believes the initiative holds promise to save money. The state anticipates savings of $11 billion to state and federal budgets over the next decade by reducing duplicated treatments and avoidable hospitalizations. Finding ways to slow the growth in health care costs is a critical challenge as baby boomers age and President Barack Obama’s health care overhaul extends coverage to millions more Americans, many of whom will join Medicaid in 2014. Under Obama’s Affordable Care Act, the federal government will pay most of the costs for the new patients. The Oregon plan would create “coordinated care organizations” to manage all mental, physical and dental care for 600,000 low-income patients on the Oregon Health Plan, the state’s Medicaid program. It would focus particularly on the sickest patients with the highest costs, especially people with chronic conditions such as diabetes and asthma or with mental health concerns. The care organizations would have to work within fixed budgets, with broad leeway to spend the way they think is best. The ones that are most successful at lower-
ing costs would see the largest profits. The model makes it possible to pay for services that keep people healthy but don’t get much funding - such as paying caseworkers to make sure patients go to medical appointments and take their medications. The state Legislature overwhelmingly endorsed the idea this year and last, though some Republicans complained that it would increase the government’s role in health care. In a statement, Health and Human Services Secretary Kathleen Sebelius said Oregon’s plan “mirrors our plan at the national level under the Affordable Care Act.” “This is another example of how we are collaborating successfully with states in their efforts to find innovative health care solutions that work for their communities,” Sebelius said. Kitzhaber cleared his schedule at the last minute this week to fly to Washington, DC, and finalize the deal for the money. The federal money will lessen the impact of payment cuts to providers and help them pay the upfront costs of the new initiative before the savings can kick in. Oregon, facing a budget shortfall, planned to severely cut payments to doctors, hospitals and other care providers beginning this summer. Potential coordinated care organizations, which had been working to comply with proposed requirements, were eager to find out how much federal money would be available. Many will have to upgrade their computer systems so patient records can be shared, or hire new staff to manage patient care. They face a May 14 deadline to submit financial proposals to the state. The changes will initially apply only to Medicaid patients, but Kitzhaber wants to eventually extend it to government workers and the general public. State and federal officials are still negotiating the final details and hope to finish in time to make the first payment, $620 million, on July 1. About 50 groups have applied to become coordinated care organizations, with some hoping to begin operating on Aug. 1. Federal money is a “transformational achievement” but there are still significant challenges looming, said Joe Robertson, president of Oregon Health & Science University in Portland, a hospital and medical school. “There is a lot of hard work ahead of us to achieve $11 billion in savings,” Robertson said. “Today’s news is encouraging, but we must always focus on long-term solutions.” —AP