John Makely / NBC News

Sisters Cathy Balsamo, left, Patti Broccoli, center, and Cindy Lepore, right, have all tested positive for the BRCA1 genetic mutation that raises the risk of breast and ovarian cancer. All three sisters have had preventive surgery to have their breasts and ovaries removed. Two weeks after her surgery, Broccoli was diagnosed with breast cancer.

Actress Angelina Jolie’s revelation this week that she’d had both breasts removed to lower her elevated risk of cancer came as a bombshell to many -- but not to three sisters from Berkeley Heights, N.J.

The women -- Cathy Balsamo, Cindy Lepore and Patti Broccoli -- have spent most of the past year grappling with the very dilemma that Jolie faced: What to do when a genetic mutation means you’ve got a sky-high chance of breast or ovarian cancer?

“Rich, poor, famous, not famous -- it’s the same decision,” said Balsamo, 46, who was the first to learn last spring that she had a mutation of the BRCA1 gene, which boosts the risk of both kinds of cancer.

“It doesn’t make it easier or harder.”

The family -- which includes the three sisters and a brother, Joseph Zichichi, 48 -- offers an extreme example of the issues now illuminated by Jolie’s spotlight. 

Like Jolie, all three women opted for preventive double mastectomies. Unlike Jolie, who’s 37, the 40-something sisters also all had concurrent operations to remove their ovaries. Jolie wrote in the New York Times that she plans to have that surgery later.

“The option of waiting and watching was never an option,” said Broccoli, a 49-year-old nurse. “Why would we wait for cancer?”

Though their mother, Patricia Zichichi, had always warned of a family history rife with cancer -- a grandmother and two great-aunts died young of what was then called “women’s cancer” -- the sisters didn’t know about their actual genetic risk until Balsamo asked her doctor to perform the BRCA test in April 2012.

“He was just so upset and said ‘I hate to have to tell you this,’” recalled Balsamo, who is an activity director at a nursing home. “Immediately, when he said BRCA1, breast and ovarian, I said, ‘I’m getting a double mastectomy and a hysterectomy.”

Within weeks, her sisters had the same test -- with the same results. It’s not surprising that all three women would turn up positive for BRCA mutations, said Dr. Larissa Korde, a breast cancer specialist at the Seattle Cancer Care Alliance in Washington. If one parent carries the defective gene, there’s 50 percent chance any child will get it.

“Sometimes you see it in families where everybody’s got it,” Korde said. “It’s just chance.”

A woman with a harmful BRCA1 or BRCA2 mutation has a 60 percent chance of developing breast cancer during her lifetime, about five times higher than the overall rate of 12 percent, cancer experts say. She has a 15 percent to 40 percent lifetime chance of getting ovarian cancer, compared with about 1.4 percent in the general population.

With those odds, the sisters opted for surgery within months of each other. Lepore, 42, a respiratory therapist who has type 1 diabetes, had her initial and reconstruction surgeries last October. Broccoli had her surgery in January and Balsamo followed in February.

Ironically, Broccoli’s preventive surgery actually may have saved her life. Two weeks after her double mastectomy in January, she was diagnosed with breast cancer -- but at such an early stage her chance of cure is very good. A mammogram and two MRIs before surgery had suggested strongly she was cancer-free, but doctors detected ductal disease after Broccoli's operation. 

“I consider it a blessing,” said Broccoli, who lost her hair to three rounds of chemotherapy. “I know what could have happened if it hadn’t been caught early.”

Rates of women opting for preventive mastectomies have risen by as much as 50 percent in recent years, cancer experts estimate. That's despite the small chance of getting cancer anyway, the risk of major surgery and the fact that there are alternatives, including drugs and careful monitoring. 

Still, some women who learn of BRCA mutations are devastated by the information -- and by the dilemma of whether to have surgery, Korde said. “I’ve definitely had women who were through childbearing and who feel emotionally conflicted about losing their breasts.”

But the New Jersey sisters aren’t among them. “For me, it was a no-brainer,” Balsamo said. “The good of it outweighed the bad. So I don’t have terrific boobs. I’ll never have nipples. I didn’t have that emotional thing.”

John Makely / NBC News

The sisters all live within a mile of each other in Berkeley Heights, N.J. They say they've supported each other through the ordeal.

What does make them emotional, the sisters said, is what the genetic legacy might mean for the rest of the family. Joe Zichichi is scheduled to be tested for BRCA mutations soon, too, the women said.

The results could have implications for him in the form of an increased risk of pancreatic, prostate or other cancers, doctors say.

“There’s more to BRCA genes than breast and ovary cancer,” said Dr. Eileen O’Reilly, a gastrointestinal cancer specialist at Memorial Sloan Kettering Cancer Center in New York. “As much as 5 percent of pancreatic cancer risk might be related to BRCA mutations.”

But the family is especially concerned about possible future effects on their children. They all live within a mile of each other; there are 13 grandchildren in the family, including Joe Zichichi’s four daughters.

Two of the granddaughters are in their early 20s. The U.S. Preventive Services Task Force recommends BRCA testing only for women with a strong family history of cancer, about 2 percent of all women in the U.S. But for those with that high risk, testing can be done at age 25.

Whether such young women choose to be tested -- and what action they’ll take afterward -- is something serious to ponder, the sisters said. 

“We have a good four years to figure this out,” said Balsamo. “God willing there will be something in that period of time that helps our daughters deal with it.”

It’s not clear when Jolie learned of her genetic risk or how long it took to decide that surgery was the best option. Her decision has prompted a flood of calls and inquiries to cancer centers nationwide, including Korde’s, and to geneticists, said Dr. Michael Watson, executive director of the American College of Medical Genetics and Genomics.

The New Jersey sisters said they’re grateful for the awareness that Jolie’s decision brings to an issue that has become central to their daily lives.

“I was actually very happy,” said Lepore. “In this world, it takes someone like Angelina Jolie to get recognition of important things.”

What choice would you make if you had a BRCA mutation, dramatically raising your cancer risk? Talk about it on Facebook.

Related stories: 

• More women opting for preventive mastectomy -- but should they be?
• Angelina Jolie: I had a double mastectomy because of high breast cancer risk
• Doctors detail Angelina Jolie's breast cancer surgery

Erik S. Lesser / EPA for NBC News

Dr. Hunter Johnson, a pathology resident at the Emory University School of Medicine, has helped at least four patients with C. difficile infections by giving them a dose of his stool. Fecal transplants have been shown to have a 90 percent success rate of curing the potentially deadly infection.

An Emory University medical resident has taken the notion of donation to a whole new level, agreeing to provide stool samples for multiple patients who need life-saving procedures called fecal transplants.

Dr. Hunter Johnson has aided at least four people in the past year by providing doses of his healthy feces -- yes, poop -- to help cure devastating bowel infections caused by a nasty germ known as C. difficile.

“As you can imagine, it’s not the most glamorous thing,” says Johnson, 30, of Atlanta, who was recruited by his boss, Dr. Colleen Kraft. “It’s hard enough to get people to donate blood, but it’s much harder to get people to donate feces.”

Kraft, an infectious disease specialist and clinical microbiologist at Emory, turned to Johnson and other medical residents last summer, when a gravely ill lung transplant patient came down with a C. diff infection as well.

“Basically, we had been doing it using a family member or friend to donate and this patient didn’t have anyone who could help,” she said. That's where Johnson came in. 

The process worked, allowing the woman to recover from the bowel infection with the help of a stranger’s stool.

Fecal transplants are rapidly becoming a treatment of choice for recurrent C. diff infections, which strike more than 336,000 people each year and are linked to 14,000 deaths, according to the Centers for Disease Control and Treatment. 

In the procedures, stool from a healthy patient is transplanted into the colon of a C. diff sufferer to restore the balance of bacteria. C. diff infections typically occur following heavy antibiotic use, when the drugs kill healthy bacteria in the gut, allowing toxic germs to flourish.

Though they sound distasteful, fecal transplants have been racking up success rates as high as 90 percent or more. Sufferers say they recover swiftly after the transplants, returning to full health within a few days.

“I’m telling you, I can’t say enough good things about this thing,” said Tom Wilson, 76, who received one of Johnson’s stool donations in March.

Wilson, who was treated for a serious bowel condition called diverticulitis in 2006, developed a life-threatening case of C. diff last December and was severely ill for months. He tried a fecal transplant using a sample from a family member, but it wasn’t completely successful.

When he fell ill again, doctors sent the real estate developer from Alpharetta, Ga., to Emory for help. He said the notion of accepting stool from a stranger didn’t faze him at all.

“When you’re as sick as I have been, you’ll do anything to feel better,” said Wilson, who figures he’s nearly fully recovered.

Johnson said he gets a sense of satisfaction from helping -- and from knowing he’s advancing knowledge about a new kind of therapy.

He figures he’s a good donor because he’s young, fairly healthy, and is at low risk for infections. People with kids, for instance, wouldn’t be good choices because children bring home so many germs.

“They don’t want you to be eating anything too crazy, not a lot of travel, no history of gastrointestinal illness,” he said. “We can’t have taken any drugs in the recent past.

“Essentially, the best donor is someone who leads a pretty boring life," he added.

In addition, a good donor has to have predictable bowel habits and be able to perform, as it were, on demand. Johnson typically donates on the morning of a patient’s transplant. “They want it to be relatively fresh,” he said.

He provides the sample and then takes it to the lab, where it’s processed to be given to the patient. At Emory, they use a colonoscope to deliver the donation, though others use enemas or tubes that run through the nose and to the stomach.

Kraft has conducted the transplants on a case-by-case basis with hospital approval. She plans to apply for a investigational new drug application that would essentially define Johnson's stool as a useful medication. Meanwhile, she and others who perform fecal transplants are waiting for the federal Food and Drug Administration to weigh in on regulation of the promising new therapy.

Both Kraft and Johnson say they’re excited by the promise of fecal transplants to cure the misery of C. diff infections. “I became a physician to help people,” Johnson said. “To these patients, it’s a big deal.”

Still, he acknowledges that not everyone finds his altruism so intriguing.

“My wife is kind of tentatively grossed out by it,” he said. “It’s a little weird for her. But she realizes it’s a good thing.”

Related stories: 

• Fecal transplant from mom cures ailing toddler
• Sounds gross, works great: Fecal transplants cure nasty C. diff infections

Wrigley is pulling its new caffeinated energy gum from the market temporarily after Food and Drug Administration officials said they’re investigating the impact of a proliferation of caffeine in food and drink.

Company officials announced they would suspend production, sales and marketing of Alert Energy Caffeine Gum, which contains 40 milligrams of caffeine per piece -- about the same as half a cup of coffee. The move comes a little more than a week after the product’s April 29 launch.

FDA officials said the company agreed to halt production after discussions about the need for a regulatory framework governing the appropriate uses of caffeine in food and beverages.

“The company’s action demonstrates real leadership and commitment to the public health,” Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said in a statement.

Wrigley officials had marketed the gum to adults and said it shouldn’t be used by children or those sensitive to caffeine.

FDA’s probe follows growing concern over caffeine-containing energy drinks, which have been mentioned in connection with at least 25 deaths and 150 illnesses over several years, according to FDA reports. (The filing of a report doesn’t mean that a death or illness was attributed to the product, however.)

At the same time, other foods ranging from caffeinated water to jelly beans and popcorn have been introduced to a market aimed largely at children and teens.

Health officials, including the American Academy of Pediatrics, recommend that children limit consumption of caffeine, including caffeinated energy drinks.

Related stories: 

• Caffeinated gum raises buzz about health effects
• When caffeine kills: Energy drinks under the spotlight

David Maxwell / EPA

The house where Amanda Berry, Gina DeJesus and Michelle Knight, as well as Berry's 6-year-old daughter, were held.

Of the four captives rescued in this week’s hostage drama in Cleveland, the 6-year-old daughter of Amanda Berry may raise the most perplexing questions of all.

The young girl who followed as Berry, 27, kicked her way out of a house where she’d been held in alleged bondage for a decade will face complicated challenges as the youngster learns to navigate an entirely new universe, say child therapists and specialists in long-term trauma.

“For a child born into this situation, this is the only world that child has known,” said Rona Fields, a Washington, D.C., clinical psychologist and author who works with women who seek asylum from trauma.

Even an abusive world can seem normal, especially to a child who police reports indicate was denied typical experiences such as school, health care and play time with other kids.

“When they’re exposed to fear and threats and exploitation of a parent, that has a significant psychological impact on the child’s development and the child’s sense of safety,” said Terri Weaver, a professor of psychology at St. Louis University who specializes in post-traumatic stress disorder and the mental health effects of family violence and sexual assault.

The three women -- Berry, Gina DeJesus, 23, and Michelle Knight, 32 -- reported being bound in ropes and chains, isolated in locked rooms and forced to endure rapes, pregnancies and miscarriages, police said.  It’s not clear whether Berry’s daughter, born in captivity, was also abused. Berry's sister spoke briefly to a throng of reporters on Wednesday, pleading for time for her family to absorb the week's events.

"I just want to say we are so happy to have Amanda and her daughter home," said Beth Serrano. "At this time our family would request privacy so my sister and niece and I can have time to recover."

But experts say a child as young as 6 has a good chance of overcoming such a traumatic early life, especially with the help of a supportive family and community -- and specific, targeted, intensive therapy.

“These aren’t insurmountable obstacles by any means, but they are things that need to be dealt with and addressed, not in a single point of time, but as the child grows up and kind of encounters the world,” Weaver said.

Slideshow: Missing women found alive in Cleveland

Emmanuel Dunand / AFP - Getty Images

A daring escape and a dramatic 911 call led to the rescue of three women who allegedly had been held captive for years inside a home in Cleveland, Ohio.

Launch slideshow

Cases in which children are born to long-term hostages are very rare, of course, Weaver noted. Jaycee Dugard, the California woman who was kidnapped at age 11 in 1991, was held captive for 18 years, during which she gave birth to two daughters. In her book, "A Stolen Life," Dugard recounted that she insisted on educating her children in captivity. Since her rescue in 2009, Dugard, now 33, has shielded her daughters, now 18 and 15, from public view. 

The key to recovery could be the relationship between the little girl and her mom. Even in the worst situations, “there can be a great deal of love and a strong bond,” Weaver said.

The girl likely will have to grapple with conflicting feelings, especially if she regarded the alleged captor, Ariel Castro, 52,  as her father. Castro was charged Wednesday with kidnapping and rape. A DNA test was pending to determine paternity. His two brothers, who also were held, were not charged with crimes in connection with the captives.

Hostages and victims of long-term kidnappings often form bonds with their abusers over time, experts say. A report from the Cleveland Police Department indicates that Castro would sometimes take the child out with him. She was kept from knowing Knight or DeJesus' real names for fear she would say them in public, the report said. 

Such trauma in  early childhood will raise basic questions of identity: What does a "traumatic conception" mean for the child born from that union, Weaver said.

And there also will be the question of interacting with the wider world. Experience with children rescued from polygamist colonies showed that it can be difficult to counter messages ingrained since birth, said Douglas Goldsmith, executive director of the Children’s Center in Salt Lake City, Utah, which specializes in mental health care for families with young children.

“Suddenly a 6-year-old is exploring what is freedom,” said Goldsmith, who is a specialist in attachment theory, which focuses on the bond between children and caregivers. “They’ve been told to never, ever trust people in the outside world. They are absolutely terrified.”

The good news is, once they’ve been rescued, such children can almost certainly be helped, Weaver said. The first step is to make the little girl -- and her mom and the other women -- feel safe and protected. The next step will be to help the child understand what has happened and to answer any questions she may have.

After some time, the child may be treated with a cutting-edge therapy known as trauma-focused cognitive behavioral therapy, or TF-CBT. Developed during the past decade, it is now widely used to help children, families, caretakers and others process emotions and thoughts related to significant trauma, Weaver said.

One component of the therapy is creating a “trauma narrative,” where the child tells the story of the abuse, including all the scary or disturbing things that he or she saw, experienced or felt. That can help desensitize kids to the experience and allow them to work through inaccurate thoughts they may have had about what happened, experts say.

No one’s saying it will be an easy road for any of the women captives -- or for the 6-year-old born into such a world. But Weaver said she wants to offer a message of hope:

“We have effective treatments now for kids,” she said. “There is a great deal of reason to believe they can life happy, productive and successful lives.”

Related stories: 

• 'Never get over': Captives face psychic toll
• Cleveland story sparks hope for parents of missing kids
• Ohio victims describe rape and pregnancies while held captive

Mark Duncan / AP

Members of the FBI evidence team remove items from a house on Seymour Avenue in Cleveland, Ohio, on Monday after the rescue of three women who went missing separately about a decade ago.

For the three Ohio women held captive for nine years or more, the world had shrunk to a small white house on Cleveland’s Seymour Avenue.

Early reports indicated that locked doors and covered windows kept the women trapped inside the working-class dwelling. Police said they were hostages to the whims of three 50-something brothers -- until 27-year-old Amanda Berry kicked her way to freedom on Monday.

That act alone signals that Berry and the others -- Gina DeJesus, Michelle Knight, and Berry’s 6-year-old child -- might have the gumption and the resilience to recover from the ordeal, say therapists and experts in child trauma.

“It’s a really good sign. It shows a level of maturity and the ability to take positive initiative to escape a captor,” said John Fairbank, co-director of the UCLA-Duke University National Center for Child Traumatic Stress.

But, like other longtime captives – think Jaycee Dugard and Elizabeth Smart – the women will need time, support and individual attention to tackle the complex psychological demands of healing, experts said.

As many as half of kidnapping victims experience PTSD, or post-traumatic stress disorder, and about 30 percent suffered from major depression after their ordeals, according to one recent study.

It’s far too early to say how the Cleveland women will respond to the aftermath of the captivity, or to predict individual responses, therapists emphasized. Berry, DeJesus, 23 and Knight, 32, were allegedly held by Ariel Castro and brothers, Onil Castro and Pedro Castro since as early as 2002. Due to the sensitive nature of the situation, police say they haven't fully questioned the women yet. 

If they were psychologically healthy at the time they were abducted, they’ll likely come through OK, but with some common issues, said Herbert Nieburg, an assistant professor of law and justice at Mitchell College in New London, Conn. He specializes in trauma and PTSD and has been an FBI hostage negotiator.

“What we could expect logically is that they’ll have issues of trust, issues of being exploited, issues of being mind-controlled,” Nieburg said.

The women may grapple with questions about whether they tried hard enough to escape, or even whether they bonded in some ways with their captors, a common reaction.

“That’s secondary to the mind control,” Nieburg said. “I would suspect that they were told along the way that if they tried to get away that they would be hurt, or their families would be hurt.”

At the same time, the women will have to make up for missing out on crucial years of development – their teens and young adulthood, said Douglas Goldsmith, executive director of the Children’s Center in Salt Lake City.

“Now they’ve skipped their adolescence. They’re going to be struggling as adults,” he said. “If you listen to the 911 call, Amanda Berry sounded very young. She didn’t sound like a young adult.”

The 6-year-old child will need focused help, too. Though the environment may have been abusive, it is the only world the child has known, experts said. Adjusting to outside society could be a challenge. 

"The key thing is the bond with the mom," said Fairbank.

Dugard, a California woman who was 11 when she was abducted in 1991, spent 18 years living with her captor and had two children conceived by rape. Now 33, she wrote a best-selling memoir in 2011, “A Stolen Life.” On Tuesday, she said that the women’s escape demonstrates their resilience.

“This isn’t who they are,” she said in a statement. “It is only what happened to them.”

Elizabeth Smart was 14 when she was abducted at knifepoint from her Utah bedroom in 2003 and then held for nine months. Now 25, she has since written a book, married, and started a foundation to promote awareness about abduction.

She told ABC News on Tuesday that she was “overjoyed” to hear that the Ohio women were free.

“It’s just proof that there are more happy endings out there,” she said.

But Smart also said that the women will need privacy to heal, “to give them every chance they can to find their own way, to find their pathway back to some sense of healing.”

Therapists and fellow victims alike agreed that the Cleveland woman have taken the first step of what will be a long journey.

“They’ll never get over what happened,” Goldsmith said. “What they have to do is figure out, ‘How do I incorporate this trauma into my life?’” 

Related stories: 

• Nine years before rescue, cops visited Cleveland home where women were held
• 'Can I help?' Neighbor tells of role in discovery
• 5 missing child cases with happy endings

Reports of a new “sex superbug” threatening the U.S. aren’t true, public health officials say, even as they reiterate worries about the rise of drug-resistant gonorrhea.

“The sky is not falling -- yet,” said Dr. Kimberly Workowski, a professor of infectious disease at Emory University in Atlanta.

Several media outlets, including The Associated Press, last week reported that a rare strain of gonorrhea known as HO41 had been detected in Hawaii. That would have raised alarms nationwide, signaling the first domestic sign of a strain that's been found to be resistant to ceftriaxone, an injectable antibiotic that is the last-resort treatment for the sexually transmitted infection.

But the Hawaii cases, first discovered in May 2011, were actually a different strain, H11S8, resistant to a different drug, the antibiotic azithromycin, state health officials confirmed. That’s been a known problem for a while, Workowski added. The AP later withdrew the inaccurate report.

In fact, the HO41 strain hasn’t been detected anywhere in the world since 2009, when it was found in a Japanese sex worker, said Dr. Robert Kirkcaldy, a medical epidemiologist with the Centers for Disease Control and Prevention.  A handful of other cases that are resistant to ceftriaxone have been detected in other countries, but they’re different isolates, he added.

The false reports have put public health experts in the unusual position of refuting an error while also emphasizing that the threat of untreatable gonorrhea in the U.S. is very real.

“We think that that could be just a matter of a year or two,” said William Smith, executive director of the National Coalition of STD Directors.

Nearly 322,000 cases of gonorrhea were reported in the U.S. in 2011, making it again the second most commonly reported notifiable infection in the nation. Sufferers often show no signs, so the actual number of infections is likely closer to 700,000, according to the CDC.

For decades, gonorrhea was easy to treat with a single dose of antibiotics. But the germ is wily and easily mutable. It developed resistance to successive classes of drugs over the years until the cephalosporins, the current treatment, were all that’s left.

In recent years, though, there have been worrisome signs that the bug is starting to outsmart those drugs, too. Last year, the CDC stopped recommending the oral antibiotic cefixime to treat gonorrhea after surveillance showed it was on the verge of resistance. Now, the recommended treatment is the injectable ceftriaxone along with two other antibiotics, azithromycin or doxycycline.

“The point was to actually preserve the last remaining drug we know is effective,” said Workowski.

The NCSD, led by Smith, has asked Congress for $54 million in emergency appropriations to help bolster the US public health infrastructure that monitors, diagnoses and treats gonorrhea.

“Untreated gonorrhea is a disaster for public health and HIV prevention,” Smith said.

The best prevention against gonorrhea is monogamous sex between uninfected partners, Kirkcaldy said. Diligent use of condoms can also prevent infection, he added.

Related stories: 

• 'Ongoing, severe epidemic' of STDs in the US
• Untreatable gonorrhea threat rises in the U.S., Canada
• Bad bug: Gonorrhea strain resists all drugs

U.S. Department of Justice officials have filed notice that they will appeal a federal judge's order requiring the Food and Drug Administration to make the so-called "morning after" pill available without a prescription to all women without age or certain sales restrictions. 

The department also has asked the federal district court to stay its order, which was set to take effect on May 6, according to Allison Price, a spokeswoman. 

The move comes a day after the FDA agreed to lower the age limit to 15 for sales of non-prescription Plan B One-Step emergency contraception and to make the drug available in the general aisles of stores with pharmacies, instead of behind the counter. 

 Justice officials appeared to be concerned by the precedent the order would send in overturning a top administrative decision. Officials said that the court exceeded its authority by specifying action regarding the one-pill Plan B One Step product and by ordering the FDA to make emergency contraception available instead of sending the issue back to the agency for reconsideration, documents showed.

"Although FDA did not take that action for purposes of complying with the April 5 order, the approval has the effect of ensuring that all of the plaintiffs in this case (including the youngest of them) now have access without a prescription and without significant point-of-sale restrictions to at least one form of emergency contraception ..." reads a letter sent late Wednesday by justice officials to U.S. District Judge Edward Korman. "As a result, no plaintiff will be harmed by a stay."

Early last month, the New York judge ordered the FDA to reverse a 2011 agency decision and make emergency contraception containing levonorgestrel available to all women without a prescription and over the counter within 30 days. In the acidly worded ruling, the judge criticized the FDA and Health and Human Services Secretary Kathleen Sebelius for politicizing the availability of a drug that medical experts had concluded was safe and effective for women of all ages. In the 59-page ruling, he said that Sebelius' actions were "politically motivated, scientifically unjustified and contrary to agency precedent." 

But on Tuesday, the FDA granted an amended application from Teva Women's Health Inc., to make just Plan B One-Step available to girls as young as 15 without a prescription starting immediately. Under the previous ruling, the drugs were available without a prescription to girls and women older than 17. Consumers will find the product in the family planning and women's health aisles of stores with in-store pharmacies and they'll be available outside pharmacy hours. But shoppers will have to show identification to buy the products and they won't be sold if ID can't be verified, the FDA said. 

Reproductive-rights advocates who brought the lawsuit that led to Korman's order were frustrated at the decision. 

"Women who urgently need emergency contraception have been delayed in getting it or denied access entirely for more than a decade because of the political maneuverings of the last two presidential administrations," said Nancy Northup, president and chief executive of the Center for Reproductive Rights. "The federal court has made clear that these stalling tactics were based purely on politics, not science."

Terry O'Neill, president of that National Organization for Women, called the move "a step backwards for women's health."

"Millions of women need access to this safe and effective product, and the prevention of unwanted pregnancy, particularly in adolescents, should not be obstructed by politics," she said. 

Officials with Planned Parenthood said that lowering the age at which the drug is available without a prescription was a good move that should go further. 

"The Obama Administration took an important step forward earlier this week by moving emergency contraception out from behind the pharmacy counter and making it available to people ages 15 and older and we continue to believe that access should be expanded further," Cecile Richards, the agency's president, said in a statement.

A doctor who backed wider access said that advocates will still work toward the goal of reducing unwanted pregnancies.

"If someone had said to me years ago that we were allowing a 15-year-old girl to get this, it would be such progress," said Dr. Cora Breuner, a Seattle pediatrician and professor of adolescent medicine who authored the American Academy of Pediatrics guidelines on emergency contraception.

"We're getting there," she said. "It's a step in the right direction." 

Related: 

• Plan B available for 15-year-olds: Bring a passport
• FDA approves Plan B One-Step for girls 15 and older without prescription

Reproductive-rights groups and women's health advocates say that a Food and Drug Administration decision to expand use of the so-called "morning after" pill not only thwarted a federal judge's ruling calling for unrestricted access, but also raised practical hurdles such as: Where will a 15-year-old get valid ID?

The U.S. Department of Justice on Wednesday said it intends to appeal an April federal district court order that would have made certain emergency contraception products available over the counter to all women without a prescription.  

But the FDA on Tuesday lowered the age limit for Plan B One-Step emergency contraception, making it available without a prescription to girls as young as 15 and putting it on the shelves of stores with pharmacies instead of behind the counter.

In a letter requesting a stay of the order set to take effect May 5, justice department officials told U.S. District Court Judge Edward Korman that although the move wasn't intended to address his order, it has the "effect" of ensuring access to emergency contraception for even the youngest plaintiffs in the lawsuit. 

But women's rights advocates said the decision also requires girls and women to show ID at the cash register and denies sale if they can’t produce it, noted Terry O’Neill, president of the National Organization for Women. 

“Fifteen-year-olds don’t drive, so they won’t have state-issued identification,” she said. “It’s also anyone who looks 15 to the cashier. They will be carded at the cashier’s desk. That sets up the possibility of humiliation. You’re setting up humiliation for the most vulnerable population.”

Some girls that young could use learner's permits, which are available at age 15 in at least 30 states. State identification cards can take weeks to arrive. 

FDA officials said a 15-year-old could use an alternative form of identification such as a birth certificate or a passport to buy the drug.

“If a 15-year-old is unable to verify their age, they will not be able to purchase Plan B One-Step,” said Stephanie Yao, an FDA spokeswoman.

The FDA’s approval of Plan B One-Step applies only to that product, which uses a single dose of levonorgestrel to prevent pregnancy when taken within 72 hours of unprotected intercourse. It does not apply to Plan B and other generic products that use two lower doses of the drug to stop pregnancy, or to ella, ulipristal, a prescription-only product.

Korman’s ruling would have applied to all emergency contraception that contains levonorgestrel.

In that order, Korman delivered scathing criticism of a 2011 decision by Health and Human Services Secretary Kathleen Sebelius that overruled recommendations by an FDA committee and Commissioner Margaret Hamburg to make Plan B available without age and point of sale restrictions. He wrote that the action was “politically motivated, scientifically unjustified and contrary to agency precedent.”

Sebelius was briefed on Teva’s Plan B One-Step application and review process before the FDA's approval and said that her concerns about access to the drug for very young girls were met, a Health and Human Services official told NBC News.

Speaking to reporters Wednesday after an appearance at a Latino Coalition forum, Sebelius affirmed the move: “The FDA made the decision and I support the decision,” she said.

But O’Neill said that vetting the process with Sebelius amounts to allowing politics to once again influence an issue that should be settled by science.

“Because she has already interfered once, my concern is that she might do it again,” she said.

Emergency contraception products use a high dose of hormones used for birth control to prevent or delay ovulation, prevent fertilization or, in some cases, prevent implantation of a fertilized egg. It does not end an existing pregnancy or harm a growing fetus, medical experts say.

Anti-abortion groups have consistently opposed emergency contraception because they believe it induces abortion, contrary to FDA claims. At the very least, they urged retention of the current law that requires prescriptions for Plan B for women younger than 17.

“The FDA is recklessly positioning itself as a parent to our children,” said Marjorie Dannenfelser, president of the Susan B. Anthony List, an anti-abortion group. “Fifteen-year-old girls need the protection that comes with the involvement of real parents and doctors in their lives. Expanded access to potentially dangerous, abortion-inducing drugs does not strengthen children or families.”

But one advocate for emergency contraception said the FDA’s decision to expand access to Plan B One-Step could be interpreted as a step forward. Dr. Cora Breuner, who wrote the American Academy of Pediatrics guidelines on emergency contraception, said she was torn by the current situation.

On one hand, doctors and scientists long ago confirmed that the drugs are safe and effective. On the other hand, expanding access to girls as young as 15, without a prescription and on store shelves is undeniably progress toward reducing unwanted pregnancies.

“It feels close, but not quite there,” she said. “Better, but not quite perfect.”

Related stories: 

• FDA approves Plan B without prescription for girls 15 and older
• Judge: Make Plan B available to all without prescription

Getty Images / stock

Roller-coasters and other amusement rides cause about 4,400 injuries to kids younger than 17 every year, a new study finds. Most of the injuries aren't serious, but researchers say that better tracking and oversight would improve safety.

Roller-coasters, carnivals and kiddie rides may be a staple of summer fun, but a massive study of hospital injury records shows there’s a downside to the thrill: 4,400 kids a year who get hurt.

Most of the injuries are not serious -- just bumps and bruises, but about 67 kids a year, or 1.5 percent, are injured badly enough to be hospitalized, according to an analysis of data from the National Electronic Injury Surveillance System, which includes reports from about 100 nationally representative hospitals. It's the most in-depth study to date, tracking 20 years of injuries which occurred at fixed-site amusement parks, mobile carnivals and fairs and coin-operated rides at places like malls, stores and restaurants.

About 20 kids a day are hurt on rides in the peak season between May and September. “That’s one every two hours,” said Dr. Gary A. Smith, who conducted the research for Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.

Such harm -- and the most in-depth study to date on ride injuries -- highlights the need for more awareness, better education, and increased tracking and oversight, he said.

“In the past, the discussion has always been on roller-coaster injuries and the bigger rides,” Smith said. “The message here is that these injuries occur across a broad spectrum of types of rides and across many locations.”

Nationwide Children's Hospital

Destini Lofton, now 13, broke her left wrist on an indoor roller coaster ride in Chicago when she was 8.

Destini Lofton was 8 when she broke her wrist in 2008 on an indoor roller-coaster in Chicago.

“She turned around to high-five one of her nieces,” recalled Crystal Malone, 47, Destini’s mother. “Her wrist caught between the rides.”

Overall, some 92,885 children ages 16 and younger were injured on amusement rides between 1990 and 2010, Smith’s team found. Researchers conducted a case-by-case review of more than 5,626 narratives from the NEISS reports.

Officials with the International Association of Amusement Parks and Attractions or IAAPA are quick to note, however, that about 297 million people -- adults and children -- safely rode 1.7 billion rides in the U.S. in 2011.

“Injuries are rare, especially in the context of the tremendous number of rides given each year,” said Colleen Mangone, a spokeswoman for the group. She estimated that the likelihood of being seriously injured at a fixed-site amusement park ride in the U.S. about 1 in 24 million.

The most serious injuries are deaths, of course, but the new report didn’t include how many children died because fatalities aren’t tracked by hospital injury reports. Fifty-two deaths tied to amusement rides were logged between 1990 and 2004, according to a 2005 report by the Consumer Product Safety Commission, but no later figures are available, a spokesman said.  

More girls than boys were hurt on rides -- 55.5 percent vs. 45.5 percent -- which was a surprise because boys are typically more injury-prone in such studies, said Smith, who didn’t have a good explanation for the result.

Most kids were hurt during falls, with nearly 32 percent of injuries caused by falling in, on, off or against rides. The head and neck was the most common body part hurt, 28 percent, and soft tissue injuries were the most common kind, accounting for 30 percent of the harm, the study showed.

Big, fixed-site amusement parks appeared to account for about 33 percent of the injuries, with mobile carnivals responsible for about 30 percent. That’s an uncertain figure, though, because in about 25 percent of cases the particular site was unknown.

Surprising, though, was that nearly 12 percent of injuries reportedly were caused by rides at malls, stores, restaurants or arcades.

“These might be areas where kids might go for birthday parties,” he said.  

The youngest children, those aged 0 to 5, were most likely to be hurt on those rides, and they were more than twice as likely to suffer concussions and 1.76 times more likely to suffer cuts.

That’s likely because a very young child’s center of gravity is so high, it makes them prone to topple headfirst when they fall. And the coin-operated rides often lack sturdy restraints or a cushioned surface on which to fall.

That spotlights a problem with amusement park rides: uncertain regulation. The CPSC oversees mobile rides used for carnivals and fairs, but it has no jurisdiction over fixed-site rides at big parks or small malls. Instead, various state and local authorities are responsible for those rides, so even limited common standards often aren’t followed.

That issue, combined with spotty tracking of injuries and deaths, means that it’s impossible to tell exactly which attractions are responsible for most harm, or whether it’s getting worse over time.

“I think fear mongering is the easy thing to do, but that doesn’t really solve the problem,” Smith said. “I try to do these reports in a way that we can inform the public, information the industry and inform policy makers. We want to inform the people who have the ability to keep kids safe.”

Related stories: 

• Mystery illness sickens Disney 'Africa Trek' visitors
• Officials probe amputee's roller coaster death

Uncredited / AP

This undated image made available by Teva Women's Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill."

U.S. regulators on Tuesday lowered the age limit for Plan B One-Step emergency contraception, approving it for sale to girls as young as 15 and agreeing it will be available without a prescription and on store shelves instead of behind pharmacy counters, Food and Drug Administration officials announced. 

The move, which grants an amended application by drugmaker Teva Women's Health Inc., is a separate action from a federal judge's ruling earlier this month that ordered the FDA to make the so-called "morning after pill" available to girls and women of all reproductive ages. It comes just days before U.S. District Court Judge Edward Korman's decision is set to take effect.

"The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling," agency officials said in a statement.

Under the FDA's latest action, the emergency contraception will now be labeled as not for sale to those younger than 15 and will require proof of age. It will not be available where age cannot be verified, but will be sold during normal retail hours outside pharmacy hours, likely in the women's health or family planning aisles. In addition, Teva has arranged to have a security tag placed on all cartons to prevent theft.

The action alters the FDA’s controversial decision in December 2011 not to make Plan B One-Step available over the counter to girls younger than 17. At that time, Health and Human Services Secretary Kathleen Sebelius overruled an FDA committee recommendation -- and Commissioner Margaret Hamburg -- to force the agency to limit access to emergency contraception to younger girls. That move was hotly disputed by medical experts who said the drug was safe and effective for girls and women and widely regarded as an effort to avoid political fallout for President Barack Obama's administration during an election year.

In granting Teva’s amended application Tuesday, Hamburg said it was based on science that shows access to emergency contraception has the potential to decrease the rate of unintended pregnancies in the U.S.

“The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease,” Hamburg said in a statement.

U.S. Department of Justice officials are still considering whether to appeal Korman's April 5 decision, which reversed the 2011 FDA ruling and orders the agency to make emergency contraception products that contain levonorgestrel available without age or so-called “point of sale” restrictions. The FDA has 30 days, or until May 5 or 6 to take action.

In a sharply worded 59-page ruling, Korman said the FDA's decisions about the drug were "politically motivated, scientifically unjustified and contrary to agency precedent."

The ruling appeared to apply to Plan B One-Step and generic brands of the morning-after pill, although Korman gave the FDA the option of limiting the expanded access just to Plan B One-Step, if the agency believed that the one-pill option was better than products that use two pills.

The Teva approval drew praise from officials at Planned Parenthood officials, who supported wider access to emergency contraception. 

"While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy," agency President Cecile Richards said in a statement. "Emergency contraception is a safe and effective form of birth control that can prevent pregnancy if taken within five days of unprotected sex. This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy."

However, the move to approve Teva's application without addressing the judge's order was sharply criticized by the reproductive rights advocates who brought the lawsuit in 2001. 

“Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women -- but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend," said Nancy Northup, president and chief executive of the Center for Reproductive Rights, which brought the lawsuit. 

“These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women," she added.

The application from Teva, based in North Wales, Pa., was pending before the judge's ruling, FDA officials said. Denise Bradley, a Teva spokeswoman, called the approval "a significant milestone for women."

Anti-abortion advocates objected to making emergency contraception more available to young girls  because they believe that the emergency contraception drugs induce abortions. 

Plan B One-Step is an emergency contraceptive aimed at reducing the possibility of pregnancy if taken within three days of unprotected intercourse. It uses a single pill that contains a high dose of the same hormone used in birth control pills to prevent or delay ovulation, prevent fertilization or, in some cases, prevent implantation of a fertilized egg in the uterine lining. Plan B One-Step will not end a pregnancy if a woman is already pregnant and there is no medical evidence it harms a developing fetus, FDA officials said.

Plan B, available from generic manufacturers, uses two doses of levonorgestrel. Another emergency contraceptive, ella, or ulipristal, is a prescription-only product that prevents pregnancy when taken within five days of unprotected intercourse. The FDA's decision Tuesday does not affect Plan B or ella. 

Emergency contraception products do not protect against sexually transmitted diseases. 

Related stories: 

• Judge: Make Plan B available to all girls without prescription

A new line of caffeinated chewing gum is causing jitters among health advocates and prompting federal officials to take a new look at the proliferation of jolt-infused foods, including those marketed to children and teens.

Wrigley on Monday announced the launch of its new Alert Energy Caffeine Gum, which contains 40 milligrams of caffeine per piece – about the same as a half cup of coffee.  “The right energy, right now,” is the product’s slogan, according to the website of the company that is a subsidiary of Mars, Inc. The gum comes in blister packs of eight pieces. 

In response, Food and Drug Administration officials said they would review the cumulative effect of caffeine in an environment in which it’s being added more often to sodas, snacks and other foods.

“FDA is taking a fresh look at the potential impact that the totality of new and easy sources of caffeine may have on the health of children and adolescents, and if necessary, will take appropriate action,” Mike Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said in a statement.

Wrigley

Wrigley introduced its new Alert Energy Caffeine Gum Monday. Each piece contains 40 milligrams of caffeine, about the same as half a cup of coffee.

The move follows growing concern over caffeine-containing energy drinks, which have been mentioned in connection with at least 25 deaths and 150 illnesses over several years, according to FDA reports. (The filing of a report does not mean that a death or illness was attributed to the product or that the product caused it, however.) 

At the same time, other foods  ranging from caffeine-spiked water to amped-up popcorn have been introduced to a market largely aimed at children and teens, according to the Center for Science in the Public Interest, a health watchdog group.

“Could caffeinated macaroni and cheese or breakfast cereal be next?” CSPI executive director Michael F. Jacobson said in a statement.

One serving of caffeinated foods isn’t likely to hurt anyone, he added. But the concern is that it will become too easy to consume copious amounts of caffeine throughout the day, sometimes unwittingly. CSPI said a vigorous social media campaign indicated the new gum was being marketed to young people. 

On its website, Wrigley says that the gum is aimed at adults looking for an energy boost and that it’s not recommended for children or people sensitive to caffeine. Because the gum is not a dietary supplement, the company will not have to submit any reports of adverse events to the FDA, said agency spokeswoman Shelly Burgess. 

The American Academy of Pediatrics discourages the use of caffeinated energy drinks, saying “they have no place in the diet of children and adolescents,” according to a 2011 paper.

It’s not that caffeine should be “demonized,” said Dr. Steven Abrams, a professor of pediatrics at the Baylor College of Medicine and a member of the AAP’s committee on nutrition.

But too much caffeine from too many sources could cause problems including anxiety, restlessness and sleepnesses in mild cases to rare problems such as rapid heartbeat and seizures in severe cases.

“You’ll get a cumulative effect that’s hard to control,” Abrams said.

Related stories: 

• Monster says its drink didn't kill girl, 14
• When caffeine kills: Energy drinks under the spotlight

Elaine Thompson / AP

Officials in Washington and Colorado are struggling to come up with new health and safety rules to cover new markets after those states legalized recreational marijuana use.

Marijuana may soon become mainstream for adults in Colorado and Washington state, but before it reaches that point, regulators face a tall task: making sure that newly available pot products don’t become a hazard to public health.

Months before legal sales of the drug begin, officials in both states are struggling to come up with health and safety rules to govern a menu of marijuana offerings ranging from leafy greens to food and drinks.

Pot, like other agricultural commodities, could be subject to problems ranging from mold, mites and pesticide residue in the raw plants to solvents, E. coli, salmonella and run-of-the mill food safety risks in prepared products, experts say.

Government agencies such as the Food and Drug Administration won’t weigh in because marijuana remains illegal under federal law. That leaves state officials to come up with a framework for policing production and distribution for an entirely new industry.

“It’s important for us to do it because it’s public safety and there’s no U.S. FDA oversight here,” said Randy Simmons, the Washington State Liquor Control Board project manager in charge of implementing Initiative 502. “Things that would be FDA rules don’t exist.”

Voters in both states legalized recreational marijuana use for adults last fall. Washington is set to issue producer, processor and retail licenses by Dec. 1; Colorado is set to start sales by January. 

As it stands now, laws in both states skirt the public health issues of medical pot production. No quality control tests are required; there’s no mechanism for recalling contaminated pot products. And the framework for new rules remains a work in progress.

“Currently, there’s really nothing codified,” said Julie Postlethwait, spokeswoman for the Colorado Department of Revenue, which will run a new adult marijuana program. Under that state’s existing law, medical marijuana products were explicitly excluded from state rules governing food and drugs.

In Washington state, a burgeoning market for “medibles” -- foods infused with medical marijuana -- has flown almost entirely under any regulatory radar.

Producers like Karen Brower, co-owner of Puff n Stuf products, say they’ve taken it upon themselves to make sure that food safety is a top priority.

“I’m concerned about it, of course, because that’s huge for us,” says the 54-year-old Tacoma woman. “If the health department came into my kitchen, I’m sure that I would pass.”

Marijuana susceptible to mold, pests
Still, there are no tests for Brower or her partner, Julie Guterson, 54, to take, no inspectors to review her stainless steel sinks or to review the sanitizing cycle of her dishwasher. She sees the need for new regulations for the larger recreational pot market, but she’s worried it might create stricter standards that her small operation will be unable to meet.

“We just put our nose to the grindstone and we just keep pumping out medibles for patients,” she said. “That’s what we’re going to do right now.”

John Brecher / NBC News

Julie Guterson sells cannabis-infused foods at the Puff n Stuf booth in one of the two locations of the NW Cannabis Market in Seattle. "I'm working out of my home. We have no pets - we tie our hair back and wear clean shirts."

Some larger producers, however, didn’t wait for government officials to impose health and safety standards. Tripp Keber, chief executive of Dixie Elixirs & Edibles in Denver, says his multiple product lines of pot-infused mints, candies, snacks and sodas already adhere to federal standards for quality.

“Anyone can make a pot brownie, but fewer can make a dozen,” he said. “Even fewer can make 5,000 with the same consistency.”

Keber claims to be the largest tester of medical cannabis in Colorado, sending samples of raw material and finished products to CannLabs Inc., a medical marijuana testing laboratory.

Genifer Murray, the lab’s chief executive, says she conducts tests now for potency and for the presence of solvents, but adds that there’s so much more that could be detected.

“We will offer pesticide and microbial testing,” she said. “A lab previous to mine has found E. coli and salmonella in the flowers.”

Marijuana is susceptible to pests and to mold, which can pose a health hazard. There have been at least two cases of fungal lung diseases linked to consuming moldy marijuana, according to a 2011 report in the Mediterranean Journal of Hematology and Infectious Diseases.

'Someone's going to cut a corner'
Simmons, the Washington state project leader, says that officials there have done the research they need to create a new system for regulation, one that likely will be modeled on existing state Department of Agriculture food safety regulations. Draft rules are scheduled to be issued in mid-May and refined after public comment.

The new standards will have to provide methods not only to detect impurities, but also to confirm the strength of the active ingredients. Plus, they will need to provide rules for reflecting those findings on the labels, experts say.

With testing and quality control in place, the available marijuana may become even more attractive to consumers seeking the assurance of regulation, said Mark Kleiman, a professor of public policy at the University of California, Los Angeles, who is advising Washington about its new law.

“The commercial system will be able to compete with the medical market and the illicit market if it offers not only legality, but a product of known content and an absence of harmful contaminants,” he said.

The prospect of an expanded adult marijuana market also leaves advocates eager for mandatory testing – and new certification for the labs that do it.

“There’s never been a death from cannabis use,” says Murray, “but my worst fear is a death down the road from cannabis contamination.”

That view is shared by Randy Oliver, chief scientist at Analytical 360, a Seattle laboratory that tests marijuana. He’s seen his share of insects, mites and powdery mold on improperly tended marijuana.  

“My feeling is that whoever’s producing it, they’re responsible for making sure that it’s safe for their customers,” he said. “But you know someone’s going to cut a corner.”

Related stories: 

• Marijuana pill may be better for relieving pain
• Does pot really lower IQ? It's not so simple
• Pot may increase stroke risk in younger adults