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Tue, 11/26/2013 - 2:52am
Emergency Contraceptive Pill Might Be Ineffective For Obese
by Julie RovnerNovember 26, 2013 2:52 AM Listen to the Story Enlarge image i
Levonorgestrel, one of the main ingredients in emergency contraceptive pills, including Plan B, was found in a recent study to be less effective in overweight and obese women.Justin Sullivan/Getty Images
The Food and Drug Administration says it is reviewing whether the maker of the most widely used emergency contraceptive pill needs to change its label in light of new evidence that it doesn't work to prevent pregnancy in overweight or obese women.
The word comes as news broke Monday that makers of a similar product in Europe have re-labeled their "morning after pill" to reflect the latest scientific findings that the hormone levonorgestrel starts losing its effectiveness in women weighing as little as 165 pounds and loses it completely in women who weigh more than about 175 pounds.
The realization that the pill doesn't actually work to prevent pregnancy after unprotected sex in overweight or obese women came as sort of an accidental finding of a much broader study. It was comparing the effectiveness of several different kinds of emergency contraceptives. Levonorgestrel is also the active ingredient in Plan B, the drug approved to be sold earlier this year without a prescription and without age restrictions after a decade-long battle
Diana Blithe, a contraceptive researcher at the National Institute of Child Health and Human Development and one of the authors of the study, said the findings came as something of a surprise to the researchers.
"It wasn't obvious," Blithe says, "until you had enough numbers of women in a population when you have a substantial number of women who are obese to really do that analysis" — such as in the United States, where nearly two-thirds of adult women are technically considered overweight or obese.
But Linda Prine, medical director of the Reproductive Health Access Project and a practicing family doctor in New York City, says the findings don't come as a surprise to her plus-size patients.
"I have had many patients say to me, 'Yeah, I got pregnant using that.' So they've had the experience already of it not working," she says.
Still, Prine says she was shocked when she saw the data at a medical meeting earlier this autumn. And she worries that not enough women know about it.
"I don't know that the word is really out there enough yet, and that really concerns me, because this can cost women $50 a pop to take this medication, and then it doesn't work and then they're pregnant," Prine says.
Researcher Blithe says it's not clear why the drug stops working in heavier women. She says it might have to do with metabolism, or with the volume of the medication in the bloodstream. And would a higher dose of the drug work? No one knows.
"There's a possibility, but it has to be tested," she says.
But Blithe says one thing is clear. Now that the effect is known, the makers of all of the products containing levonorgestrel — not just Plan B, but all its generic copies — should be required to tell women about it.
"I think it is incumbent upon American manufacturers to put that information on the label now that they're aware of it," she says.
Teva Pharmaceuticals, the company that makes Plan B, said it would not comment on its discussions with the FDA. But in Europe, HRA Pharma, the makers of a similar product, Norlevo, have already changed their product's label. Still, Linda Prine says that for over-the-counter products, a label change might not be enough because many women don't read fine print.
"I would like to see a big sign in the drugstore myself that says, 'Warning: This medication does not work if weight is over this or BMI is over that,' " Prine says.
So what should heavier women do instead if they need an emergency contraceptive? On that, Blithe and Prine agree: There are other options.
"I'm telling patients that depending on their weight, I would prefer, and I recommend, that they either use a different medication for emergency contraception, called ulipristal acetate, or Ella, or that they use a copper IUD, which is the best method of all of them because it works all the time," she says.
The study found that Ella also stops working for obese women over a certain weight, although at much higher weights than Plan B.
Meanwhile, the FDA said in a statement that it is "currently reviewing the available and related scientific information on this issue" and will determine "what, if any, labeling changes to approved emergency contraceptives are warranted."Copyright 2013 NPR. To see more, visit http://www.npr.org/.
Mon, 11/25/2013 - 5:55pm
Yes, Your Toddler Really Is Smarter Than A 5-Year-Old
by Nancy ShuteNovember 25, 2013 5:55 PM Enlarge image i
Children under age 2 can reason abstractly, researchers say.Jandrie Lombard/iStock
Parents, does your 18-month-old seem wise beyond her years? Science says you're not fooling yourself.
Very small children can reason abstractly, researchers say, and are able to infer the relationships between objects that elude older children who get caught up on the concreteness of things.
In experiments at the University of California, Berkeley, children as young as 18 months were able to figure out the relationship between colored blocks.
The child would watch a researcher put two blocks on top of a box. If the blocks were identical, the box would play music. The majority of children were able to figure out the pattern after they were shown it just three times. They would then help the researcher pick the correct block.
The toddlers did much better at this task than do chimpanzees and other primates. The non-human primates have to practice doing the task themselves thousands of times to figure it out. And even then, it's only with lots of treats thrown in.
That's not such a big surprise. What really got the researchers' attention is that the diaper set did better at this sort of abstract thinking than children who were just a few years older.TED Radio Hour What Do Babies Think?
"Older kids tend to be really bad at analogies," says Caren Walker, a graduate student at in cognitive development who led the study. It was published online in the journal Psychological Science. She says that older children tend to focus on the objects rather than the relationships between them. "Learning may actually harm these kids' abilities to do abstract reasoning."
Walker is working in the lab of Alison Gopnik, a developmental psychologist who has made a career out of devising experiments that reveal the inner thoughts of children still too young to talk. Her take is that babies are smart, and in many ways smarter than adults.
In this experiment, the box actually hides a wireless doorbell, and the researcher moving the blocks controls the music by tapping a hidden button with her foot. But the illusion of control is compelling, not just for the toddlers but for the parents who watch the experiment with their children, Walker says.
The researchers tested their hypothesis by running the same experiment but letting the children see only one of the pair of blocks. They couldn't get the right answer more often than they would by chance. By contrast, 61 percent of the children got it right when they could see the blocks.
And in a third variation, almost 80 percent were able to correctly deduce that they needed to choose sets of blocks that included pairs if they were going to do the experiment.
"Even as incredibly young children, 18-month-olds are extremely powerful little learning machines," Walker told Shots.
Walker and Gopnik are repeating the same experiment with older children, to see if they do indeed lose this very early ability to think abstractly, only to regain it later in the context of language and culture.Copyright 2013 NPR. To see more, visit http://www.npr.org/.
Mon, 11/25/2013 - 3:55pm
FDA Tells 23andMe To Stop Selling Popular Genetic Test
by Scott HensleyNovember 25, 2013 3:55 PM 23andMe/YouTube
You don't need to be an expert in the regulations covering medical tests to know that the Food and Drug Administration has just about had it with Silicon Valley's 23andMe.
The agency told the seller of a personalized genomic test to knock it off in a sternly worded warning released Monday. The 23andMe spit kit and personal genome service, or PGS, are being marketed without FDA's blessing, the letter says. "Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device," the agency concludes.Additional Information: Related NPR Stories FDA To Personal Gene Testers: Show Us Your Data June 14, 2010 23andWho? Genetic Testing Company Mixes Up Results June 8, 2010
The company's $99 test promises to tell you if your kids are at risk for a range of inherited health conditions, your own genetic health risks and even how you're likely to respond to certain drugs.
That last claim really peeved FDA. People's genes can affect how they'll respond to blood thinners and cancer drugs, such as fluorouracil. But how accurate are the test's results? And even if they are spot on, what if someone taking one of the drugs stopped or adjusted the dose after looking at the test results and before consulting a doctor? Changes like those pose a serious risk of injury or death, the agency says.
23andMe has filed paperwork with the FDA about the tests, but evidently not enough to satisfy the agency. And, to make matters worse, the FDA says it hasn't heard from the company since May.
What does the company say? Spokeswoman Kendra Cassillo emailed Shots:
We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.
The company also posted its statement on Facebook. And commenters quickly weighed in, most of them in strong support of 23andMe. "Pathetic," wrote Grant Williams. "The FDA has no right to tell me what I can learn about my own genetic information."
But Chris van Loeben Sels responded to Williams on Facebook:
Actually, the FDA's concerns are quite reasonable. If you're going to claim these medical benefits, if people are going to take the results to doctors, if we're going to rely on them for medical action, they should be licensed for accuracy just like an x-ray machine or anything else. I'm really surprised to hear that the FDA has been talking to 23andMe for years with such little progress. For 23andMe to launch TV ads knowing that the FDA was examining their marketing claims is even more surprising. To keep selling the kits online with no reference to the FDA action on the site — and not even changing the at-issue claims — is astounding.
Since 2009, the FDA's letter says, the agency has had "more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications" in which the agency has explained what it wanted and given 23andMe feedback on its work.
The final FDA gripes are about a bunch of new ads this year that expanded the company's marketing claims when there had been no progress on getting the old ones squared away.
It's pretty clear that in the FDA's view, 23andMe has run out of time to show that its tests are up to snuff. "FDA is concerned about the public health consequences of inaccurate results," the agency wrote, and it wants to "ensure that the tests work."
The company has 15 days to respond to FDA's letter.Copyright 2013 NPR. To see more, visit http://www.npr.org/.
Mon, 11/25/2013 - 4:00am
Health Exchanges Brace For A December Deluge
by Julie RovnerNovember 25, 2013 4:00 AM Listen to the Story
The race is on to get the federal insurance website HealthCare.gov working smoothly by the end of November.
And it's not just because that's what federal officials have promised. December could see a surge in demand for health insurance.
"There is an avalanche coming," says Bryce Williams, managing director for exchange solutions at the benefits consulting firm Towers Watson.
Williams says the firm knows from years of experience with open enrollment for Medicare patients, that the Monday after Thanksgiving is always the single busiest day for business.
"People will have been thinking about this over the holidays and talking to family members, and they are going to feel an impetus to do something on that Monday; and there is going to be a huge crush," he said.
Why December? Well, it finally represents a deadline. Originally you had to sign up by Dec. 15 in order to have your insurance coverage begin Jan. 1. Last week the administration extended the deadline to Dec. 23.
Robert Laszewski, who runs his own health consulting firm, Health Policy and Strategy Associates, says there are still two big groups that will try to squeeze through the tight enrollment window.
One group includes those who have received cancellation notices from their insurance companies and who need insurance that meets the health law's new requirements.
The other group includes people who have been shut out of coverage until now because of pre-existing conditions and who have been waiting for HealthCare.gov to get its act together.
"We've got all these people that have been sitting desperately next to their computers trying to get enrolled in guaranteed-issue health insurance that has subsidies for the first time in American history," said Laszewski. "And they're looking forward to coverage on Jan. 1."
The administration says it's ready — or will be by its self-imposed Nov. 30 deadline. The website should be able to handle 50,000 users at the same time by the end of this month, HealthCare.gov repair czar Jeffrey Zients told reporters in a conference call Friday. That would double its current capacity.
But he said the administration isn't depending on the website alone to handle the traffic surged expected in December. "We're also beefing up additional paths for enrollment — through the call centers, in-person assistance, and ... direct enrollment with issuers," he said.
When Zients talked about direct enrollment, he meant allowing individual insurance companies, as well as large Web-based brokers, to sign up people so they don't even have to visit the federal website. Right now that can happen for people who aren't eligible for government subsidies to help them afford coverage. But subsidy calculations still have to run through HealthCare.gov.
That frustrates people like Towers Watson's Williams. His company is one of five major Web brokers that was supposed to be helping enroll people, but it hasn't been able to sign up those eligible for subsidies because the technology to help their websites connect to the federal website is not yet working.
"It's a little like trying to sell someone something without actually showing them the price tag," he says. "Consumers are going to be skeptical until they have the information to be able to understand 'what is my true net cost.'"
Gary Lauer, CEO of online insurance giant eHealth, is also frustrated at his company's inability to sign up people who are eligible for subsidies. "We have an agreement with the federal government in the 36 states where they're operating an exchange to be able to do that, but frankly the technology's not working," he said.
Lauer says fully online companies like his are crucial for getting young people enrolled when the federal site can't accommodate them. And getting enough young healthy people to offset the older, sicker ones is critical to the success of the entire enterprise.
"Young people have grown up in front of monitors and keyboards; and now they communicate through their hands — through smartphone devices, through tablets," he says. "They don't want to go to a call center; they're not going to fill out paper applications like it's 1975. They want to do this online at 1 in the morning."Copyright 2013 NPR. To see more, visit http://www.npr.org/.
Mon, 11/25/2013 - 2:54am
In Pregnancy, What's Worse? Cigarettes Or The Nicotine Patch?
by Jon HamiltonNovember 25, 2013 2:54 AM Listen to the Story Enlarge image i Illustration by Daniel Horowitz for NPR
Lots of studies have shown that cigarette smoke isn't good for a fetus. So many pregnant women use nicotine gum or skin patches or inhalers to help them stay away from cigarettes.
A few years ago, Megan Stern became one of those women. "I smoked heavily for the first seven weeks of my pregnancy because I didn't know I was pregnant," she says. "It was an accidental pregnancy, and I found out while I was in the emergency room for another issue."
Stern, who lives in Massachusetts, was 21 at the time and had been smoking since she was 14. So she spoke with an attending physician at the hospital about quitting. "I said, 'I want to, but I'm afraid I'll mess up and I won't be able to do it,' " Stern says. "He suggested that I use the patch and prescribed it for me."
No one knows exactly how many women use nicotine replacement therapy during pregnancy. But the number is probably large. Each year, more than 500,000 babies in the U.S. are born to women who smoked while they were pregnant. And surveys show that up to 30 percent of doctors offer nicotine replacement to pregnant women who smoke.
“ I smoked heavily for the first seven weeks of my pregnancy because I didn't know I was pregnant.
- Megan Stern
Yet researchers have widely differing views on whether pregnant smokers should consider nicotine replacement. Some think it's a good way to reduce a fetus's exposure to many of the toxic chemicals other than nicotine found in cigarette smoke. Others point to studies suggesting that nicotine replacement doesn't help pregnant women quit smoking, and that nicotine itself can endanger a fetus.
"Let's first start with, does it work?" says Ted Slotkin, a professor of pharmacology at Duke University School of Medicine. "The answer is not very well or not at all."
For a typical smoker, nicotine patches, gum, lozenges or inhalers can double the likelihood that an effort to quit will succeed. But studies haven't shown that kind of success in pregnant women.
Just last year, the New England Journal of Medicine published a study of 1,000 pregnant smokers in the United Kingdom. All of them got counseling and were asked to wear an adhesive patch on their skin. Some women got nicotine in the patch and some women got placebo. There was no difference in the women's quit rate.
“ I used the nicotine patch for about two months, and then I was done completely and I had quit smoking. It did work.
- Megan Stern
By the time the women gave birth, the ones who got nicotine replacement were just as likely as those who didn't to have resumed smoking, the study found. But the women who got nicotine patches had been less likely to smoke early in their pregnancies.
That sort of result suggests nicotine replacement may help a mom even if she doesn't quit, Slotkin says. "It's much better that she takes nicotine instead of all the other smoke products, because they're going to cause lung cancer and other things."
But it's not clear whether her baby is better off. There are thousands of chemicals in cigarette smoke, and it would be almost impossible to figure out how each one affects a fetus.
The real question, Slotkin says, is how many of the health problems seen in the offspring of smokers are due to nicotine? "And the answer is, an awful lot."Shots - Health News How A Pregnant Woman's Choices Could Shape A Child's Health
Animal studies show that nicotine is especially disruptive to a developing brain. This may be why women who smoke are more likely to have children with problems including ADHD and conduct or learning disorders.
Brain development is a delicate process controlled by chemical signals that act a bit like a piano score. Ordinarily, the signals make sure that individual brain cells play the right note at the right time. But nicotine interferes with these chemical signals.
"It would be the equivalent of trying to play this piano piece and some clown comes along with a chunk of two-by-four and slams a bunch of keys down and holds them down," Slotkin says.Shots - Health News E-Cigarettes May Match The Patch In Helping Smokers Quit
A developing brain can repair the damage when signals are interrupted temporarily, Slotkin thinks. So pregnant smokers who use nicotine replacement might be better off avoiding the patch, which provides a continuous dose of nicotine through the skin.
In contrast, gum or lozenges or inhalers allow nicotine levels to fall between doses. But the best option for a pregnant smoker, Slotkin says, is no nicotine at all.
Going cold turkey is daunting for a lot of smokers, though, including Megan Stern, the Massachusetts mom. "I used the nicotine patch for about two months, and then I was done completely and I had quit smoking," she says. "It did work."
“ I just know that nicotine is a negative thing to experience, and [my son] experienced it up until he was a 4-month-old fetus. That's a pretty long time.
- Megan Stern
A number of researchers believe nicotine replacement therapy can help some pregnant women smoke less even if they can't quit. They also say it's hard to draw conclusions from some of the big studies of nicotine replacement in pregnant women.
For example, the study of pregnant smokers in the U.K. is hard to interpret because only 7 percent of the women who got nicotine patches actually used them correctly, says Dr. Cheryl Oncken, a researcher at the University of Connecticut Health Center. The rest simply stopped using the patches after a few weeks.
In her own research, Oncken has found that nicotine gum does help. "It helped women reduce their smoking but not actually quit," she says. The study also showed that women who used nicotine gum had lower overall exposure to nicotine and had babies who weighed more.
And nicotine isn't the only toxin in cigarette smoke that can affect brain development, Oncken says. There's also a lot of carbon monoxide, which has been shown to damage fetal brain cells. "And there are other things that could be neurotoxic," she says, "such as lead, there's arsenic, there's a lot of bad things in cigarettes."
“ He's a great little kid. He's really smart and he's fascinated by all kinds of scientific stuff. He loves to go on nature walks and collect samples. He has a microscope.
- Megan Stern
Unfortunately, science has yet to provide the solid answers that pregnant smokers need to assess nicotine replacement therapy. "There's no clear path to follow," she says. "So the decision has to be between the patient and her health care provider."
That's how Megan Stern ended up using a patch while she was pregnant. Her son is now 5 and has some problems with behavior and attention, she says. "There could be a lot of reasons for that," she says. "I just know that nicotine is a negative thing to experience, and he experienced it up until he was a 4-month-old fetus. That's a pretty long time."
But Stern says she doesn't dwell on how smoking or nicotine might have affected her son. "He's a great little kid," she says. "He's really smart and he's fascinated by all kinds of scientific stuff. He loves to go on nature walks and collect samples. He has a microscope."Copyright 2013 NPR. To see more, visit http://www.npr.org/.