Health & Fitness (231)
SOUTH BEND, Ind. (AP) -- The University of Notre Dame on Tuesday filed another lawsuit opposing portions of the federal health care overhaul that forces it to provide health insurance for students and employees that includes birth control, saying it contravenes the teachings of the Roman Catholic Church.
The lawsuit filed in U.S. District Court in South Bend claims the Affordable Health Care Act violates Notre Dame's freedom to practice religion without government interference. Under the law, employers must provide insurance that covers a range of preventive care, free of charge, including contraception. The Catholic Church prohibits the use of contraceptives.
The lawsuit challenges a compromise, or accomodations, offered by the Obama administration that attempted to create a buffer for religiously affiliated hospitals, universities and social service groups that oppose birth control. The law requires insurers or the health plan's outside administrator to pay for birth control coverage and creates a way to reimburse them.
The Rev. John Jenkins, Notre Dame's president, said that wasn't enough.
"The government's accommodations would require us to forfeit our rights, to facilitate and become entangled in a program inconsistent with Catholic teaching and to create the impression that the university cooperates with and condones activities incompatible with its mission," he said in a statement.
Notre Dame says in the lawsuit that its employee health plans are self-insured, covering about 4,600 employees and a total of about 11,000 people. Its student health plans cover about 2,600 students. The lawsuit says the health plans do not cover abortion-inducing products, contraceptives or sterilization.
"The U.S. government mandate, therefore, requires Notre Dame to do precisely what its sincerely held religious beliefs prohibit - pay for, facilitate access to, and/or become entangled in the provision of objectionable products and services or else incur crippling sanctions," the lawsuit says.
Notre Dame argues that the fines of $2,000 per employee if it eliminates its employee health plan, or $100 a day for each affected beneficiary if it refuses to provide or facilitate the coverage, would coerce it into violating its religious beliefs.
Daniel Conkle, an Indiana University professor of law and adjunct professor of religious studies, said Notre Dame's arguments are similar those in a case last month where a federal judge in Pennsylvania granted the Pittsburgh and Erie Catholic dioceses a delay in complying with the federal mandates.
The Obama administration argues that the burden on the Catholic entities is minimal, Conkle said. Notre Dame and other Catholic groups say it's substantial.
Steve Schneck, director of the Institute for Policy Research & Catholic Studies at Catholic University of America, said the administration's accommodations "are sufficient to protect the Catholic conscience for administrators of these plans at Catholic universities." But he said the lawsuits were still needed.
The accommodations "really rest on the good graces of the administration and those good graces could disappear with a new administration," he said.
Notre Dame argues that it is not seeking to impose its religious beliefs on others, but that it just wants to protect its right to the free exercise of its religion. The lawsuit argues that the government could pay for contraception through the expansion of its existing network of family planning clinics or by creating a broader exemption for religious employers.
Notre Dame filed a similar lawsuit in May 2012. U.S. District Judge Robert Miller Jr. dismissed that case last December, saying the university wasn't facing any imminent penalty or restrictions because the federal government was reworking some of the coverage regulations.
The U.S. Supreme Court recently agreed to consider two cases in which business have objected to covering birth control for employees on religious grounds. Hobby Lobby, a Christian-owned arts and crafts chain with 13,000 full-time employees, won its case in lower courts, while Conestoga Wood Specialties, a Mennonite-owned company that employs 950 people in making wood cabinets, lost its claims in lower courts.
About 40 for-profit companies have requested an exemption from covering some or all forms of contraception.
LONDON (AP) -- A local British authority is coming under harsh criticism for having a court declare a pregnant Italian woman incompetent, forcing her to have a cesarean section and then taking her baby into custody.
Much is unknown about the case of an unidentified Italian woman with a history of mental illness who came to London last year. According to a court ruling in June, she was "profoundly unwell" and experiencing paranoid delusions when she was detained at a hospital in Essex, east of London, under Britain's Mental Health Act.
In August, the Court of Protection, which makes decisions for people deemed unable to decide for themselves, made an "unusual order" that gave doctors in Essex permission to perform a cesarean section against the woman's will. Essex officials say the woman was too sick to care for her baby, which has been put up for adoption.
The woman has since hired a British lawyer to try to get her baby back. She has two other children in Italy who are being cared for by her mother. The baby's father is a Senegalese man living in Italy who has not been involved in the case.
Legal experts said the decision to force the woman to have a C-section was very rare but potentially justifiable if the woman was unable to make medical decisions for herself.
"You can only perform a C-section against a woman's will if she lacks capacity and it is in her best interest (medically)," said Penney Lewis, a medical law expert at King's College London.
John Hemming, a member of parliament and the chair of an advocacy group called Justice for Families, has questioned why the baby was placed for adoption.
"We still need answers," he said, wondering why the Italian woman was kept in England for six weeks before being given a C-section. He also called for an explanation as to why the woman's mother was not given custody of the baby.
Hemming said the failure of Essex officials to contact Italian authorities about the mother's detainment and the care of her baby violates international law. He has put forth a parliamentary motion that calls for increased transparency and says the British government must comply with international treaties.
The Essex County Council said in a statement that its social workers liaised extensively with woman's extended family to see if anyone could care for the child and that adoption was not considered until all other options were exhausted.
The British charity Bipolar UK also called the forced C-section and the continued separation of mother and child "unprecedented."
"If there were continuing concerns about the care of the child, one would have thought Italian social services would have been involved in determining what was best for the child," the group said in a statement.
It was not known exactly what mental illness the woman was diagnosed with.
Lewis, the legal expert, said there have been only a handful of forced C-sections in the past 15 years in Britain.
FORT LAUDERDALE, Fla. (AP) -- Counselors helping people use the federal government's online health exchange are giving mixed reviews to the updated site, with some zipping through the application process while others are facing the same old sputters and even crashes.
The Obama administration had promised a vastly improved shopping experience on healthcare.gov by the end of November, and Monday was the first business day since the date passed.
Brokers and online assisters in Utah say three of every four people successfully signed up for health coverage on the online within an hour of logging in. A state official overseeing North Dakota's navigators said he had noticed improvements in the site, as did organizations helping people sign up in parts of Alabama and Wisconsin.
But staffers at an organization in South Florida and a hospital group with locations in Iowa and Illinois said they have seen no major improvements from the federal website, which 36 states are relying on.
Amanda Crowell, director of revenue cycle for UnityPoint Health-Trinity, which has four hospitals in Iowa and Illinois, said the organization's 15 enrollment counselors did not see a marked improvement on the site.
"We had very high hopes for today, but those hopes were very much quashed," said Crowell. She said out of a dozen attempts online only one person was able to get to the point of plan selection, though the person decided to wait.
The site appeared to generally run smoothly early Monday morning before glitches began slowing people down. By 10 a.m., federal health officials deployed a new queue system that stalls new visitors on a waiting page so that those further along in the process can finish their application with fewer problems.
About 750,000 had visited the site by Monday night - about double the traffic for a typical Monday, according to figures from the Centers for Medicare and Medicaid Services.
Roberta Vann, a certified application counselor at the Hamilton Health Center, in Harrisburg, Pennsylvania, said the site worked well for her Monday morning but she became frustrated later when the site went down.
"You can get to a point, but it does not allow you to select any plans, you can't get eligibility (information). It stops there," she said. "The thought of it working as well as it was didn't last long."
In South Florida, John Foley and his team of navigators were only able to successfully enroll one of a handful of return applicants who came to their office before glitches started, including wonky estimates for subsidy eligibility. He worried about how they would fare with the roughly 50 other appointments scheduled later in the week.
Although frustrated, most were not deterred, he said.
"These are people that have policies going away, who have health problems. These are people that are going to be very persistent," said Foley, an attorney and certified counselor for Legal Aid Society of Palm Beach County.
Despite the Obama administration's team of technicians working around the clock, it's not clear if the site will be able to handle the surge of applicants expected by the Dec. 23 deadline to enroll for coverage starting at the beginning of the year. Many navigators also say they're concerned the bad publicity plaguing the troubled website will prevent people from giving the system another try.
"There's a trust level that we feel like we broke with them. We told them we were here to help them and we can't help them," said Valerie Spencer, an enrollment counselor at Sarah Bush Lincoln Center, a small regional hospital in the central Illinois city of Mattoon.
Federal health officials acknowledged the website is still a work in progress. They've also acknowledged the importance of fixing back-end problems as insurers struggle to process applications because of incomplete or inaccurate data. Even when consumers think they've gone through the whole process, their information may not get to the insurer without problems.
"We do know that things are not perfect with the site. We will continue to make improvements and upgrades," said Julie Bataille, communications director for the Centers for Medicare and Medicaid Services.
In less than an hour Monday, Starla Redmon, 58, of Paris, Ill., was able to successfully get into a health plan with help from an enrollment counselor. Redmon, who juggles two part-time jobs and has been uninsured for four years, said she was surprised the website worked so well after hearing reports about its problems.
"Everything she typed in, it went through," said Redmon, who chose a bronze plan and will pay about $75 a month after a tax credit. "It was the cheapest plan I could go with."
Contributing to this report were Associated Press writers Carla K. Johnson in Chicago; Chris Tomlinson in Austin, Texas; Catherine Lucey in Des Moines, Iowa; Peter Jackson in Harrisburg, Pa.; Scott Bauer in Madison, Wis.; James MacPherson in Bismarck, N.D.; Brady McCombs in Salt Lake City; and Phillip Rawls in Montgomery, Ala.
Follow Kelli Kennedy on Twitter at twitter.com/kkennedyAP.
BOSTON (AP) -- In the five years since the "Octomom" case, big multiple births have gone way down but the twin rate has barely budged. Now fertility experts are pushing a new goal: One.
A growing number of couples are attempting pregnancy with just a single embryo, helped by new ways to pick the ones most likely to succeed. New guidelines urge doctors to stress this approach.
Twins aren't always twice as nice; they have much higher risks of prematurity and serious health problems. Nearly half of all babies born with advanced fertility help are multiple births, new federal numbers show.
Abigail and Ken Ernst of Oldwick, N.J., used the one-embryo approach to conceive Lucy, a daughter born in September. It "just seemed the most normal, the most natural way" to conceive and avoid a high-risk twin pregnancy, the new mom said.
Not all couples feel that way, though. Some can only afford one try with in vitro fertilization, or IVF, so they insist that at least two embryos be used to boost their odds, and view twins as two for the price of one.
Many patients "are telling their physicians `I want twins,'" said Barbara Collura, president of Resolve, a support and advocacy group. "We as a society think twins are healthy and always come out great. There's very little reality" about the increased medical risks for babies and moms, she said.
The 2009 case of a California woman who had octuplets using IVF focused attention on the issue of big multiple births, and the numbers have dropped, except for twins.
The Centers for Disease Control and Prevention's most recent numbers show that 46 percent of IVF babies are multiples- mostly twins -and 37 percent are born premature. By comparison, only 3 percent of babies born without fertility help are twins and about 12 percent are preterm.
It's mostly an American problem - some European countries that pay for fertility treatments require using one embryo at a time.
The American Society for Reproductive Medicine is trying to make it the norm in the U.S., too. Its guidelines, updated earlier this year, say that for women with reasonable medical odds of success, those under 35 should be offered single embryo transfer and no more than two at a time. The number rises with age, to two or three embryos for women up to 40, since older women have more trouble conceiving.
To add heft to the advice, the guidelines say women should be counseled on the risks of multiple births and embryo transfers and that this discussion should be noted in their medical records.
"In 2014, our goal is really to minimize twins," said Dr. Alan Copperman, medical director of Reproductive Medicine Associates of New York, a Manhattan fertility clinic. "This year I'm talking about two versus one. Several years ago I was talking about three versus two" embryos.
The one-at-a-time idea is catching on. Only 4 percent of women under 35 used single embryos in 2007 but nearly 12 percent did in 2011. It's less common among older women, who account for fewer IVF pregnancies, but it is gaining among them, too.
"Patients don't really want multiples. What they want is high delivery rates," said Dr. Richard T. Scott Jr., scientific director for Reproductive Medicine Associates of New Jersey, which has seven clinics in that state.
Better ways to screen embryos can make success rates for single embryos nearly as good as when two or more are used, he contends. The new techniques include maturing the embryos a few days longer. That improves viability and allows cells to be sampled for chromosome screening. Embryos can be frozen to allow test results to come back and more precisely time the transfer to the womb.
Taking these steps with single embryos results in fewer miscarriages and tubal pregnancies, healthier babies with fewer genetic defects and lower hospital bills from birth complications, many fertility specialists say.
Multiple studies back this up. In May, doctors from the New Jersey clinics did the kind of research considered a gold standard. They randomly assigned 175 women to have either a single embryo transferred after chromosome screening or two embryos with no screening, as is done in most IVF attempts now. Delivery rates were roughly equivalent - 61 percent with single embryos and 65 percent with doubles.
More than half of the double transfers produced twins but none of the single ones did. Babies from double transfers were more likely to be premature; more than one-third spent time in a neonatal intensive care unit versus 8 percent of the others.
Chromosome testing and freezing embryos adds about $4,000 to the roughly $14,000 cost for IVF, "but the pregnancy rates go up dramatically," and that saves money because fewer IVF attempts are needed, Scott said. Using two or more embryos carries a much higher risk of twins and much higher rates of cerebral palsy and other disorders.
After explaining the risks, "this is the easiest thing in the world to convince patients to do," Scott said of screening and using single embryos.
But Dr. Fady Sharara of the Virginia Center for Reproductive Medicine in Reston, Va., found otherwise. For a study, he offered 48 couples free medications and embryo freezing if they would agree to transfer one at a time instead of two. Eighteen couples refused, including one-quarter of those whose insurance was covering the treatment. Some who refused said they viewed twins as two for the price of one.
"I tell my patients twins are not twice the fun," Shahara said. "One is hard enough. Two at a time is a killer for some people. Some marriages don't survive this."
The New Jersey couple, who had a daughter using a single embryo, has eight more frozen embryos. When it's time to try again, Abigail Ernst said, "we would do the same thing" and use one at a time.
CDC info on IVF: HTTP://WWW.CDC.GOV/ART/
Infertility info: HTTP://WWW.SART.ORG and HTTP://WWW.ASRM.ORG
Follow Marilynn Marchione on Twitter at HTTP://TWITTER.COM/MMARCHIONEAP
WASHINGTON (AP) -- The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.
In a warning letter posted online Monday, FDA regulators say that the Silicon Valley company has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of email exchanges." The agency orders 23andMe to stop marketing its test immediately, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.
23andMe's saliva-based test kit, launched more than 5 years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests that have been cleared by the government are permitted to make such claims.
The letter follows years of back-and-forth between the government and 23andMe, the most visible company among a new field of startups selling personal genetic information. The spread of consumer-marketed DNA tests has troubled doctors and health officials who worry that the products are built on flimsy science.
For years, 23andMe resisted government regulation, arguing that it simply provides consumers with information, not a medical service. But last year the company changed course, submitting several of the disease-specific tests included in its test kit.
A spokeswoman for the Mountain View, Calif.-based company said 23andMe recognizes it has been late responding to FDA questions about the application.
"Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns," said Kendra Cassillo in a statement.
The FDA letter suggests that regulators have gone to great lengths to try and work with the company, citing months of meetings and dozens of letters between the two parties.
"However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated" its technology, states the letter.
The FDA warning, dated Nov. 22, takes issue with a number of claims the company makes for its test kit, particularly calling it a "first step in prevention" against diseases like diabetes, heart disease and breast cancer. Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care. For instance, 23andMe says its test can identify women who carry the BRCA gene mutation that significantly increases the risk of breast and ovarian cancer. But a false result could lead women to undergo unnecessary screening, chemotherapy and surgery.
The FDA gives the company 15 days to respond in writing to the letter's concerns. Warning letters are not legally binding, but the government can take companies to court if they are ignored.
23andMe was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company over the years.
Company executives previously said that they first contacted the FDA in 2007, before launching their product. The agency did not take an interest in the technology until 2010, when it issued letters to several testing companies, warning that their products must be approved as safe and effective.
The FDA already regulates a variety of genetic tests administered by health care providers. The FDA's concern with 23andMe appears to center on its marketing approach, which sidesteps doctors and health professionals.
Consumers order the company's $99 product online. Once the kit arrives by mail they are instructed to spit into a small tube, providing a saliva sample which is sent back to the company for analysis. 23andMe says the customer's DNA is analyzed to determine their likelihood of developing various diseases and responding to various drugs. The test also claims to provide information about ancestral background, though this information is not regulated by the FDA.
PARIS (AP) -- A French contraceptive maker said Tuesday its morning-after pill doesn't work when taken by women who weigh more than 80 kilograms (176 pounds) and plans to change its labels to warn patients.
The decision to change its labels by HRA Pharma is based on a previous study of levonorgestrel, one of the active ingredients in its Norlevo emergency contraceptive, said Frederique Welgryn, HRA Pharma's head of women's health.
Some doctors said heavy women shouldn't assume emergency contraception won't work for them and that they should talk to a health professional or consider alternatives like a copper IUD, a birth control device that can be fitted on the uterus.
Norlevo is not sold in the U.S. but another drug with the same active ingredient is widely available.
Welgryn said a dose of HRA's drug contains 1.5 mg of levonorgestrel, identical to that found in Plan B One-Step, manufactured by Teva Pharmaceuticals in the U.S. Denise Bradley, a spokeswoman for the company, declined to comment.
The Food and Drug Administration is currently reviewing the issue and will determine "what, if any, labeling changes to approved emergency contraceptives are warranted," according to spokeswoman Erica Jefferson in an email.
Welgryn said that while the results of the study conducted by the University of Edinburgh in 2011 were "quite surprising," the last few years have seen much discussion about contraceptives' efficacy in overweight or obese patients.
HRA Pharma Chief Executive Erin Gainer estimated that millions of women across Europe use emergency contraceptives identical to Norlevo. Gainer declined to give sales figures for Norlevo alone.
Anna Glasier, a lead researcher in the 2011 study, said that their research wasn't designed to look specifically at the effect of weight on emergency contraception. She said their study only included about 1,700 women.
"It is not my place to comment as to whether the company's decision to change advice is premature," she said in an email.
She also noted another previous analysis that found there was no solid evidence to show that hormonal contraceptives were less effective in overweight women, but the quality of the studies was low.
The morning-after pill contains a higher dose of the hormone in regular birth control pills. Taking it within 72 hours of rape, condom failure or just forgetting regular contraception can cut the chances of pregnancy by up to 89 percent, but it works best within the first 24 hours. If a woman is already pregnant, the pill, which prevents ovulation or fertilization of an egg, has no effect.
HRA began the process of consulting with French regulators about changing the pill's labeling in 2012 and it has taken until now for Europe's drug regulators to approve the change, Welgryn said.
The new warning also says that the drug's efficacy is reduced in women who weigh more than 75 kilograms (165 pounds), and it is ineffective in women who weigh more than 80 kilograms.
Dr. Diana Mansour, a spokeswoman for Britain's Faculty of Sexual and Reproductive Healthcare, said in overweight and obese women the drug probably gets absorbed into their fat more quickly and doesn't have enough time to work in their bodies.
"It has less of a chance to delay ovulation and there are lower levels (in the blood) of the drug to have an effect," she said. Mansour said there wasn't enough information to know if simply giving obese women a higher dose of the drug would solve the problem.
In the U.K., doctors haven't been given any advice to stop giving overweight or obese women Levonnelle, which contains the same active ingredient as Norlevo.
Lynn Hearton, clinical lead for the FPA sexual health charity, said any overweight or obese women concerned about emergency contraception should speak to a medical professional.
"It is particularly important we don't put some women off taking emergency contraception because they think it won't work anyway," she said.
She said women should consider using an IUD, which can be inserted in the womb up to five days after unprotected sex.
HRA markets Norlevo in about 50 countries worldwide. It began marketing the pill in France in 1999.
It will begin printing the warning on packaging in the first half of 2014.
Cheng reported from London. Associated Press writer Matthew Perrone in Washington contributed to this report.
Follow Greg Keller on Twitter at HTTP://TWITTER.COM/GREG-KELLER
WASHINGTON (AP) -- They are among our most personal daily decisions: what to eat or drink. Maybe what to inhale.
Now that the government's banning trans fat, does that mean it's revving up to take away our choice to consume all sorts of other unhealthy stuff?
What about salt? Soda? Cigarettes?
In the tug-of-war between public health and personal freedom, the Food and Drug Administration's decision to ban trans fats barely rates a ripple.
Hardly anyone defends the icky-sounding artificial ingredient anymore, two decades after health activists began warning Americans that it was clogging their arteries and causing heart attacks.
New York, Philadelphia, a few other localities and the state of California already have banned trans fat from restaurant food.
McDonald's, Taco Bell and KFC dropped it from their french fries, nachos and chicken years ago.
The companies that fill grocery shelves say they already have reduced their use of trans fat by nearly three-fourths since 2005.
Growers are promoting new soybean oils that they say will eliminate, within a few years, the need for partial hydrogenation, the process that creates trans fats still used to enhance the texture of some pie crusts, cookies and margarine.
Mostly, Americans' palates have moved on, and so have their arguments over what's sensible health policy and what amounts to a "nanny state" run amok.
When they aren't feuding over President Barack Obama's health care law, state politicians are busy weighing the wisdom of legalizing marijuana. Already 20 states and the District of Columbia have authorized it for medicinal use. Voters in Colorado and Washington state approved smoking pot just for fun.
The FDA is taking heat for delays in coming out with new rules on regular-old tobacco cigarettes under a law passed in 2009. There are the new e-cigarettes to worry about, too. More than 20 states have banned stores from selling electronic cigarettes to minors, but the federal government has yet to take them on.
New York Mayor Michael Bloomberg's attempt to stop restaurants from selling sodas larger than 16 ounces, and the federal government's efforts to impose healthier lunches on school kids are causing more of an uproar than the trans fat ban.
Still, Jeffrey Levi, executive director of the nonprofit Trust for America's Health, says a national trans fat ban is "a big deal." After all, the FDA estimates it will prevent 20,000 heart attacks and 7,000 deaths a year.
Levi doesn't see it as evidence that federal regulators are suddenly on a roll, however.
"There are other areas where regulation is sort of stuck - everything from nutrition labeling to food safety to the tobacco regulations that have not seen the light of day," Levi said.
Talk of new government regulation typically stirs up libertarians and conservatives. Yet the trans fat ban hasn't provoked much beefing.
Radio host Rush Limbaugh groused that bureaucrats shouldn't regulate what people eat because it's "none of their business" and research on nutrition keeps changing. After all, sticks of margarine made with trans fats used to be recommended as a healthier alternative to butter.
Heritage Foundation research fellow Daren Bakst, who specializes in agriculture issues, blogged that the FDA is "ignoring the most important issue: the freedom of Americans."
A few fans of ready-to-spread cake frostings and microwave popcorn that still contain trans fat griped via Twitter.
They don't have to worry immediately.
The FDA must consider comments from the food industry and the public before it comes up with a timeline for phasing out trans fats, also known as partially hydrogenated oils. It could take years to get them off the market.
Michael Jacobson, executive director of the nonprofit Center for Science in the Public Interest, has been warning about the dangers since the early 1990s. Advocacy by the center helped persuade the government to add trans fat to nutrition labels beginning in 2006.
That created consumer pressure on food companies to find tasty ways to replace partially hydrogenated oil with less harmful fats. The companies' success helped clear the way for the government to consider a trans fat ban, he said.
"It's a little bit of an exception, in that it's so harmful and it was so widely used," Jacobson said, "and there are substitutes so that people can't tell the difference when it's removed."
Next on Jacobson's wish list is something that would be much harder for industry and the FDA to accomplish: reducing the salt in processed foods.
"There are estimates that it's causing around 100,000 deaths prematurely every year in this country," he said. "That is just huge."
Follow Connie Cass on Twitter: HTTPS://TWITTER.COM/CONNIECASS