Nicotine patches do not help pregnant women quit smoking, a new study says.

Pregnant women in the study who used nicotine patches were just as likely to continue smoking until their delivery date as women who used a placebo, the researchers said.

"Clearly, standard dose nicotine patches do not work in pregnancy as well as they do in the general smoking population," study researcher Tim Coleman, of the University of Nottingham in the United Kingdom, said in a statement.The new study is the largest of its kind to address this question.

The findings support the current guidelines from the Centers for Disease Control and Prevention that advise pregnant women against using nicotine patches because they have not been shown to help with quitting, said Dan Jacobsen, a nurse-practitioner at the Center for Tobacco Control, part of the North Shore-Long Island Jewish Health System in Great Neck, N.Y.

Instead, pregnant women who smoke should use other strategies to quit smoking, Jacobsen said, including stress management. Jacobsen's center has incorporated social media into smoking cessation therapies, using text messages to encourage and support pregnant women as they try to quit.

Smoking during pregnancy can lead to a number of health complications for the baby, including miscarriage, premature birth, low birth weight and sudden infant death syndrome (SIDS).

 The study involved 1,050 women who were 12 to 24 weeks pregnant and smoked five or more cigarettes per day. Half of the women were randomly assigned to receive a nicotine patch for eight weeks, and half received a placebo patch.

After one month, the patch seemed somewhat effective: 21.3 percent of women in the nicotine patch group had refrained from smoking, compared with 11.7 percent of placebo group.

But this effect did not last. By delivery, 9.4 percent of women in the nicotine group had quit smoking, compared with 7.6 percent of the placebo group, a difference small enough that it could have been due to chance.

Very few participants actually kept up with their treatment. Just 7.2 percent of women in the nicotine group and 2.8 percent of women in the placebo group continued wearing their patchesfor more than one month.

The number of stillbirths, miscarriages and babies of low birth weight were similar in both groups, the researchers said.

Some women metabolize nicotine 60 to 120 times faster during pregnancy, which may reduce nicotine levels in their bodies and increase withdrawal symptoms. A higher nicotine dose may be needed for the drug to be effective in pregnant women, the researchers said.

Women included in the study had characteristics of people who are highly addicted to cigarettes, Jacobsen said. For instance, the majority smoked their first cigarettes within 15 minutes of waking. (The shorter the time between waking and the first cigarette, the more addicted the person is, Jacobsen said.) It's not clear whether less addicted individuals would respond better to the therapy, Jacobsen said.

Because so few women in the study adhered to the nicotine patch therapy, more research is needed to confirm it does not cause health problems in infants, the researchers said.

The study is published in the March 1 issue of the New England Journal of Medicine.

More from Vitals:

• Many keep smoking after cancer diagnosis
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By Robert Bazell
Chief science and health correspondent
NBC News

Not long ago, statins were jokingly promoted by some doctors with a “put them in the drinking water” argument. Physicians and drug company experts suggested that the ubiquitous cholesterol-lowering drugs -- including Lipitor, Mevacor, Crestor and Zocor -- should be sold over the counter like cold medications, or offered to everyone above a certain age. The medications appeared so beneficial to health and seemed so free of side effects.

But on Tuesday, the Food and Drug Administration issued a new health alert requiring the drugs carry labels warning about confusion and memory loss, elevated blood sugar leading to Type 2 diabetes, and muscle weakness.

“These warnings should put an end to the all the silliness about giving the drugs to everyone,” says Dr. Garret FitzGerald, chairman of pharmacology at the University of Pennsylvania.

Warnings for diabetes, memory loss added to statins

There is no question that statins -- the most profitable and among the most prescribed drugs ever -- have saved or prolonged millions of lives and will continue to do so. Most people at elevated risk for heart disease should be taking statins. The big issue now will center on determining whose risk is low to moderate and may not need medication.

The not-so-well-kept secret is that a daily dose of statin allows millions to eat whatever fatty food they like without worrying how it affects their cholesterol levels. That’s a tempting proposition. At the same time, drug companies find nothing more appealing than a pill that healthy people take daily for the rest of their lives. These two motivations combine to get million on statins who may not need them -- not much of a problem if there are no risks. But now we have evidence there is.

The FDA approved the first statin, Merck’s lovastatin, in 1987. Other companies produced their own versions over the last two decades as evidence of the drugs’ effectiveness continued to accumulate, adding to their popularity.  But, early on, plenty of side effects warnings popped up. 

Every time NBC News reported on statins I would receive many communications from viewers who had suffered the muscle-weakening condition, known as rhabdomyolysis, after taking the medication. When they stopped the drug, their muscles usually returned to normal. Doctors who frequently prescribe statins report that a certain percentage -- the best guess is about ½ to 1 percent -- suffer the muscle problems. That’s a rare occurrence as side effects go, but when many millions are taking the drugs, the numbers add up.

As for elevated blood sugar and memory problems, both conditions have been reported for years, but it is harder to guess how widespread the complications are. In fact, last month, a survey of 150,000 participants in the Women’s Health Initiative -- the government’s gigantic study that ended most hormone replacement -- found that older women taking statins were 48 percent more likely to develop diabetes. (The researchers tried to control for obesity and other risk factors.)

Because most people who take statins tend to be older, they’re already more likely to develop diabetes or memory problems. The only test to accurately measure the risk from statins would be a long, controlled trial of thousands of people at low risk for heart disease where half get the drug and half get a placebo. No drug company will pay for it.   

Astra Zeneca’s Crestor remains the only statin still under patent protection, and it would be foolish for that company to go looking for harmful side effects. The government’s resources for big expensive studies grow ever more scarce. We may never know the true danger, but at least now the drugs have labels telling patients and doctors to be aware of them

Why did the FDA chose to label the drugs now when the danger signs have been around for years? There is no official answer, but the officials in charge of the FDA now have shown far more willingness to be honest about public health risks than many of their recent predecessors.

As for whether you or a loved one should be taking a statin drug: This is certainly not an automatic decision, but definitely a subject for a discussion with your physician. Because of the FDA’s labeling actions that decision should now be far better informed.

In a move that highlights dilemmas plaguing the U.S. drug supply, federal regulators warned a major manufacturer about problems including bugs in vials of sterile drugs -- insects, literally -- the same day that health officials allowed the firm to ramp up scarce medications for kids with cancer.

Food and Drug Administration officials on Tuesday posted a warning letter sent to APP Pharmaceuticals LLC of Schaumberg, Ill., citing violations at a New York plant that included insects found in clean rooms and in vials of distributed drugs and failure to report defects such as vials contaminated with foreign matter and glass.

The firm also had problems with documenting sterile technique and was marketing unapproved drugs, according to the warning.

“It is apparent that APP Pharmaceuticals LLC’s has failed to implement global corrective actions,” it said.

The letter was dated Feb. 22, the same day that APP announced it had received accelerated FDA approval to market supplies of preservative-free methotrexate to help ease a critical shortage of the medication used to treat childhood leukemia.

Earlier this month, FDA officials and cancer doctors had said the drug was in such short supply, hospitals could have run out within two weeks, jeopardizing life-saving treatment for kids with acute lymphoblastic leukemia, or A.L.L., as well as patients with other illnesses.

“I am delighted that in many cases APP Pharmaceuticals has helped to minimize shortages by significantly increasing our production,” John Ducker, the firm’s president and chief executive said in a statement last week.  APP Pharmaceuticals is a subsidiary of the German firm Fresenius Kabi Pharmaceuticals Holding Inc.

The timing was not lost on Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks the nation’s drug shortages.

“This is what I mean when I keep talking about quality issues,” said Fox, citing ongoing manufacturing problems at several U.S. plants, including APP. “All of these companies have had quality issues, yet they make the majority of drugs used in our country.”

The U.S. has logged record numbers of drug shortages in the past two years, fueled in part by sudden closures of drug plants because of problems with contamination, crumbling infrastructure and other issues, FDA documents show.

APP officials said the warning letter, which focused on problems at the firm’s Grand Isle, N.Y., plant, and the company’s efforts to ease the drug shortage crisis were two different issues.

“Methotrexate is not manufactured at the Grand Island plant and, thus, is absolutely unaffected from the warning letter,” Matthias Link, a company spokesman, wrote in an e-mail to msnbc.com.

The violations followed an FDA inspection last summer, June 13 to July 8, and the company had “already begun taking actions on most of the items listed,” Link noted.

“We take all the issues listed in the warning letter very seriously and we are committed to promptly addressing these,” he wrote.

The firm has 15 days from the date of the FDA letter to respond to the problems, including how insects came to be found in an aseptic, or sterile, room used to produce crucial drugs.

“You continued to find insects in your manufacturing area, in finished product (two vials), and you received a complaint for an insect in a distributed vial,” said the letter sent by Ronald M. Pace, director of the FDA’s New York district.

Company officials told FDA inspectors the root cause of the bug problem was with the firm’s supplier of gowns, but they had not scheduled an audit of the firm until six months later, December 2011, the warning said.

FDA officials did not immediately respond to msnbc.com questions about the timing of the warning letter and the expanded approval of APP to make injection-free methotrexate.

Agency officials last week announced they’d narrowly averted two dire shortages: first, the methotrexate scarcity, and then an ongoing shortage of the drug Doxil, used to treat ovarian and other cancers.

The agency licensed a foreign firm, Sun Pharma, temporarily to supply Lipodox, a replacement chemotherapy drug, to the U.S. market.

Balancing the demand for life-saving drugs with the demand that those drugs be safe and sterile is an ongoing challenge, noted Fox.

“Between the shortages and the quality issues, it is difficult to have any kind of confidence in our drug supply,” she said.

Related stories:

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Sweetened cereals likely contribute to the extra sugars American kids consume at home, researchers say.

America’s intake of sugary foods and drinks has dropped in recent years, but U.S. kids are still consuming too much, government researchers say.

Contrary to popular belief, most of that sweet fare is coming from home, not from school or other settings, the researchers reported in a new study released by the National Center for Health Statistics.

For parents, that means that it’s even more important to monitor added sugars in kids’ diets, even those that aren’t so obvious.

“Added sugars are in sugar sweetened cereals, muffins -- even pasta sauce,” said Cynthia Ogden, the study’s co-author and an epidemiologist with the Centers for Disease Control and Prevention. “You can see it if you read the food labels.”

The report, which tracked consumption of added sugars by children and teens from 2005 to 2008, offered other unexpected findings, said Ogden.

Researchers also found that family income made no difference in children’s sugary diets.

“We found that all kids are eating a lot of added sugars,” she said.

Most of those sugars came from foods rather than beverages, another surprise, Ogden said.

Overall, about 16 percent of the calories in the average American child’s diet came from “added sugars” -- sweeteners used in the making of foods such as breads, cakes, soft drinks, jams, chocolates and ice cream.

What’s scary is that the sweets count didn’t include naturally occurring sugars in items such as fruit and fruit juice.

The good news is that in teens, at least, consumption of added sugars appears to have declined a bit, from 22 percent to 17 percent of total calories, Ogden said. 

Still, that’s higher than federal dietary guidelines, which recommend that the total intake of discretionary calories, including added sugars and solid fats, be limited to 5 percent to 15 percent of daily caloric intake.

Dr. Wendy Slusser, a weight control expert, suspects that some of the new study’s findings might be explained by successful campaigns to get sugary drinks out of schools.

 "Other studies have shown that a good proportion of added sugars are being consumed outside the home,” said Slusser, an associate clinical professor of medicine at the Mattel Children’s Hospital at the University of California, Los Angeles and medical director for the UCLA Fit for Healthy Weight Program at Mattel. “So we’re probably seeing a drop in consumption outside the home.”

That means the next focus for intervention may be helping parents to choose healthier options for their kids to eat at home, Slusser said.

“This is an opportunity for families,” Slusser said. “There are estimates now that we could shift children’s weights back to 1970s levels if we could just take 350 calories out of a kid’s diet each day.”

One place to look is beverages, Slusser said. Some of the biggest culprits are 10 percent fruit juice drinks and sports drinks.

“Parents think they’re doing what they’re supposed to when they give their kids sports drinks on a hot day,” she said. “If you substitute water for sugary drinks, that’s a huge step in the right direction.”

Another place to lower sugar levels is in breakfast cereals, Slusser said. “You might want to give them regular Cheerios instead of Honey Nut Cheerios,” she suggested.

Avoiding processed foods is another way to skip the added sugars, noted Ogden. Choosing fresh foods and carefully reading labels of packaged goods can help.

The best way to cut down on added sugars in a kid’s diet is to make healthy eating part of the family routine, Slusser said. Make sure to leave time for a good breakfast in the morning and plan ahead for healthy snacks after school and nutritious dinners at night.

“Once there’s a routine, parents can integrate healthier foods into their children’s diets,” she notes. “When you’re always eating on the fly, you end up eating too many processed foods.”

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Kids don't get enough sleep (and neither did their grandparents)

High levels of arsenic found in fruit juice

Latest health news from Vitals:

• Raw milk a raw deal, CDC says
• PTSD from school shootings can last years
• Rich people more likely to be cheaters, study says

By Christopher Wanjek
Live Science

The rate of food-poisoning outbreaks caused by unpasteurized, or raw, milk and dairy products is 150 times greater than outbreaks linked to pasteurized milk, according to new research.

The studies were published last week by the Centers for Disease Control and Prevention (CDC) in the journal Emerging Infectious Diseases.

But alas, that number might be closer to 151 by now. A new outbreak emanating from bad raw milk in Pennsylvania, coincidentally coinciding with the release of this CDC report, so far has sickened nearly 100 people in four states.

It's not as if pasteurized milk is perfectly safe. There were 48 disease outbreaks from contaminated pasteurized milk and cheese resulting in thousands of illnesses and one death between 1993 and 2006, the period analyzed by the CDC. 

 Top 10 Mysterious Diseases 

The sale of raw milk, however, has led to 73 disease outbreaks, two deaths, and many permanent disabilities during the same period — alarming numbers considering that raw milk constitutes less than 1 percent of all dairy sales. States where raw milk sales are legal had twice as many outbreaks, the study found.

Outbreaks stem from many kinds of bacteria, such as Campylobacter, Salmonella, E. coli, and Listeria.

These outbreaks may be on the rise, too, the CDC says, given the growing popularity of raw milk products. In the 20 U.S. states that ban raw milk sales, willing consumers can circumvent the laws by forming cow-sharing cooperatives or by buying raw milk under the guise of pet food.

Raw facts
Raw milk comes straight from the dairy animal's teat to you with little processing, the way nature sort of intended this otherwise rare interspecies-sharing of lactating fluid. Humans throughout history, however, rarely guzzled milk by the glassful the way we do today. Milk usually was soured into yogurt, curdled into cheese, or made into whey or other products that could keep longer without refrigeration.

Those who did drink raw milk, an important source of protein and other nutrients, usually lived on a farm with cows or other dairy animals and benefited from a fresh product.

As milk drinking became more popular in the 20th century, governments began instituting the practice of pasteurization, which flash-boils the milk to kill most of the bacteria, good and bad. This made milk safe for consumption in cities and other regions far from a dairy farm.

But forced pasteurization in the United States in the early 20th century created a faction that has grown stronger in recent years. Proponents of raw milk argue that it is healthier, tastier and safer than conventional milk if produced correctly.

Health benefits debatable
The "healthier" argument remains unproven. Pasteurization only slightly reduces the nutritional value of milk. The reduction in vitamins B12 and E and, actually, an increase in vitamin A in pasteurized milk are of little concern because the levels are inherently so low and easily can be obtained in other foods, according to a systematic review of 40 studies published in 2011 in the Journal of Food Safety. Pasteurization reduces vitamin B2, or riboflavin; yet so too does sunlight, and raw milk sold in glass bottles loses some of its riboflavin this way.

Conversely, raw milk usually doesn't contain vitamin D, which is added to conventional milk.  The main source of this vitamin is sunlight, but many people in northern climates do not get enough sun during the winter months.  Without a supplement, children in particular would be at risk for poor bone development.

Infographic: The Power of Vitamin D

Whether raw milk can boost the immune system also is debated. A study published in 2011 in the Journal of Allergy and Clinical Immunology demonstrated that drinking raw milk was associated with lower asthma rates among farm children in rural Germany and Switzerland. Yet the effect might be due to farm living more than the milk, since research has shown that living on farms (and having pets) can stimulate kids' immune systems.

Ban it or improve it?
Taste is another thing, though. Raw milk and cheeses do have a distinctive taste, which raw-milk advocates say they are denied as a result of perverse laws that sacrifice personal liberties in the name of public health.

That is, there is no call to ban raw vegetables or seafood. In 2011, 50 people died from contaminated bean sprouts from Germany and 29 people died from contaminated cantaloupes from California, according to CDC data. Pasteurized cheese contaminated with listeria killed 52 people in 1985, the deadliest bacterial food-borne outbreak recorded in U.S. history.

Raw-milk advocates argue that unpasteurized milk from grass-fed cows raised humanely in open fields and handled hygienically is inherently safer than the milk from large and crowded commercial farms, where disease is rampant. Unfortunately, the new CDC research doesn't support this notion, because outbreaks from bad raw milk are emanating from seemingly clean and humane farms.

"Restricting the sale of raw milk products is likely to reduce the number of outbreaks and can help keep people healthier," said Robert Tauxe, CDC's deputy director of the Division of Foodborne, Waterborne and Environmental Diseases, in a press statement tied to this latest study.

In light of the CDC analysis, the best advice for raw-milk connoisseurs is to think of raw milk as analogous to raw eggs, meat, fish or oysters. Also, think twice before giving raw milk to children, as they constitute the majority of the victims of raw-milk illnesses.

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Students at Chardon High School outside of Cleveland are reeling after a school shooting that left three students dead and two others injured.
 
“It’s just a nightmare I’m waiting to wake up from,” said Mike Wargo, a senior who heard the gunshots shortly after leaving his friends in the school’s cafeteria.
 
“I can’t even imagine what the parents feel right now,” Wargo told TODAY's Savannah Guthrie through tears. ‘”I wish I was there. I’d rather take bullet for one of those five.”
 
Neither Wargo, nor most of the high school’s students were physically hurt in the attack.  But they may suffer psychological scars of guilt and grief. Mental health experts say the echoes of such a trauma can last for months -- or if untreated -- for years. 

Grief counselors are on hand to talk to students, teachers and parents affected by the Chardon, Ohio school shooting.

Post-traumatic stress disorder is a mental health condition spurred by a terrifying event. The symptoms interfere with daily life and can include flashbacks, anxiety, nightmares, difficulty sleeping or concentrating, and even physical aches and pains. 
 
“We don’t want kids to have to deal with these symptoms for the rest of their lives,” said Dr. Melissa Brymer, director of terrorism and disaster programs with the National Center for Child Traumatic Stress. “They need to get the message that … there are treatments.” Brymer has studied incidents of post-traumatic stress disorder after school shootings in Southern California in 2001 and at Virginia Tech in 2007.
 
Brymer notes that a certain amount of anxiety and stress following such an event is normal and expected. Students may not sleep well. And rumors flying about what happened exacerbate the situation.
 
Many students wrestle with guilt about whether they could have stopped the shooting or done more to save a friend or peer. In her research of the Santee, Calif., shooting that left two students dead and 13 wounded, Brymer discovered that about 40 students had information about possible threats before the shooting occured. Those people needed extra support, she said.

But not every student will react the same. 
 
“Not everyone who has been through a school shooting will get PTSD,” Brymer says. “It’s the kids who were directly exposed who are more at risk.”
 
That could include students who were in the cafeteria at the time of the shooting, those who had a friend who was killed or injured, or those who provided first aid to someone who was hurt.
 
In her research following a 2001 shooting at Santana High School in Santee, Calif., Brymer found that about 12 percent of the 1,160 students screened had some symptoms of PTSD nine months later.
 
And nearly a quarter of the students who were directly exposed to the violence suffered from some degree of PTSD nine months later, according to the study.
 
Whether and how quickly a student bounces back from the trauma of a school shooting depends on factors including the person’s social support system and individual ability to cope with stress, Brymer said. Kids with a history of mental illness or other traumas may struggle more. Girls and younger teens tend to be at higher risk for developing PTSD after trauma.

Brymer’s research highlights the importance of schools screening students for PTSD following a shooting, and the value of continuing to provide services even months after the event. She urges students, parents and staff to monitor their friends and peers for behavior changes or signs of ongoing stress.
 
“It’s important to recognize those who are truly struggling,” she said. “We know that there are effective treatments that help these students. There are mental health professional trained in trauma and grief and we want to connect them.”

In Chardon, all local schools are closed and the school district is providing free grief counseling. School District Superintendent Joe Bergant told a news conference that the community needed to spend time "reflecting on family." He added, "I hope every parent, if you haven't hugged or kissed your kids in the last couple days, you take that time."

Correction: An earlier version of this story incorrectly stated that a number of students had information about threats prior to the 2007 Virginia Tech shooting; research in fact revealed that about 40 students had information about threats leading up to the 2001 Santee, Calif., school shooting.

While the poor might seem to have the most reason to cheat and steal, the rich are more likely to be dishonest, a new study shows.

In a series of experiments, University of California at Berkeley researchers showed again and again that upper-class individuals were more prone to unethical behavior than people from more deprived backgrounds, according to the study published in the Proceedings of the National Academy of Sciences.

Paul Piff, a doctoral candidate and the study's lead author, says he was surprised at how little incentive it took to get high-income people to cheat.

In one study, for example, people were asked to play a game of chance online. The 195 volunteers were told that a die would be rolled for them five times and that the participants with the highest scores from the five rolls would get more credits toward a drawing for a $50 Amazon.com certificate. The researchers also told the volunteers to keep track of their own scores.

But Piff and his colleagues had designed the game so all players would end up with a score of 12. As it turns out, “the upper socio-economic status people were way more likely to report a score above 12,” says Piff. 

“It was fairly remarkable," he added. " You wouldn’t think that people reporting incomes of $150,000 per year would be so motivated to win this prize.”

In another study, the researchers asked 108 volunteers to fill out a survey online.  Along with questions about their backgrounds, the volunteers were asked to imagine that they were employers who needed to hire someone at the lowest salary possible. In the hypothetical, they would get a bonus if they negotiated a low enough salary. The job was one that would last just six months.

Then they were asked what they would do if a candidate came in who was willing to work for less if he could be guaranteed the job would last two years. “Thus, if participants (acting as employers) were honest about the six-month limit of the job, chances are they wouldn’t be able to negotiate a very low salary,” Piff says.

In this scenario, the wealthier participants were more likely to act unethically to get a reward.

Piff suspects that a combination of factors, including greed and a heightened sense of entitlement, are what spur the wealthy to cheat.

He got the idea for the study watching people cut others off at a four-way intersection. His sense was that the most aggressive drivers were the ones with the most expensive cars. To test this, his first experiment tabulated the behavior of 274 drivers at that same intersection. Sure enough, drivers of expensive cars were the most likely to cut others off, he found.

In a second, related, experiment, Piff and his colleagues again watched drivers -- this time to see whether people with expensive vehicles were more likely to breeze past pedestrians in a crosswalk. In California, vehicles are supposed to yield when someone is in the crosswalk.

Once again, drivers of expensive cars were more likely to behave badly.

While there are examples of rich people who are especially generous -- think Warren Buffet and Bill Gates -- money seems to have a deleterious effect on ethics in most cases, Piff says.

The solution? He suggests mandatory ethics classes for people studying economics and business.

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By MyHealthNewsDaily staff

Glenmark Generics is issuing a nationwide recall of seven lots of birth control pills. The pills are labeled "norgestimate and ethinyl estradiol tablets."

Because of a packaging error, some of the pills were placed in the wrong order within the packs, according to a statement from the Food and Drug Administration. The packs contain three types of pills with varying levels of hormones, designed to be taken at different times during a woman's cycle. 

The pills were rotated 180 degrees within the pack, so the weekly tablet orientation is reversed, and the lot number and expiration date are visible only on the outer pouch, according to the FDA. Any pack for which the lot number and expiry date is not visible is subject to recall. 

Because of this error, the daily regimen for these oral contraceptives may be incorrect, leaving women without adequate contraception, and at risk for unintended pregnancy.

These packaging defects do not pose any immediate health risks, but consumers whose pills are affected should begin using a non-hormonal form of contraception immediately, the FDA said. Patients who have the products(lot numbers are provided below) should notify their physician and return the product to the pharmacy.

Lot numbers of affected packs are as follows: 04110101, 04110106, 04110107, 04110114, 04110124, 04110129 and 04110134. The packs were distributed nationwide between Sept. 21 and Dec. 30, 2011. The complete name of the product is norgestimate and ethinyl estradiol tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic).

The error was discovered when a consumer complained she received a pack in which the tablets were packaged in reverse order, the FDA said. 

In the correct packaging configuration, the top row contains seven white to off-white tablets, and the bottom row contains seven inactive, light green tablets in bottom row ( correctly packaged packs are pictured here ).

Last month, Pfizer recalled 28 lots of generic birth control pills labeled Norgestrel and Ethinyl Estradiol tablets, when the company found some packs contained an inexact count of inert or active ingredient tablets, and tablets out of sequence. 

More information is available on  the FDA's website. 

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Using a condom isn't as easy as it may seem. For instance, don't open the packet with a sharp object, researchers suggest.

By Stephanie Pappas
LiveScience senior writer

Condoms can't prevent unwanted pregnancy and sexually transmitted disease if they're used incorrectly. Unfortunately, a new review of research finds that condom use errors are all too common.

Some of the most frequent mistakes include putting a condom on partway through intercourse or taking it off before intercourse is over, failing to leave space at the tip of the condom for semen, and failing to look for damage before use. These errors can contribute to breakage or leakage, researchers reported in the journal Sexual Health.

"We chronically underestimate how complicated condom use can be," University of Kentucky professor Richard Crosby, who co-authored the study, said in a statement. "It involves the use of a condom, while negotiating the condom use and sex with a partner all at the same time."

With perfect use, condoms prevent pregnancy with 98 percent success, according to the World Health Organization. Typically, however, the rate of unintended pregnancy with condoms is around 15 percent. [The History & Future of Birth Control]

Led by Stephanie Sanders of The Kinsey Institute for Research in Sex, Gender, and Reproduction at Indiana University, the researchers pulled together 16 years of research on condom errors and failures going back to 1995. They found 50 studies from 14 countries, though western nations such as the United States and the United Kingdom predominated. The studies involved diverse groups of participants, from married individuals to sex workers to college students; as such, there were a range of condom use-error rates.

An analysis of all 50 studies found a laundry list of reported errors in condom use. For example, between 17 percent and 51.1 percent of people queried in the studies said they'd put on a condom partway through intercourse — negating any disease-controlling benefits, since fluids are exchanged throughout intercourse not just during ejaculation. Other studies found that between 1.5 percent and 24.8 percent of sexual experiences involved putting a condom on too late in the process of intercourse.

The research also turned up multiple mistakes in how people put condoms on. Up to 25.3 percent said they unrolled the condom's sheath before putting on the condom, rather than unrolling the condom on the penis. Between a quarter and almost half of respondents said they'd failed to leave room at the tip of the condom for semen to collect. About 75 percent of men and 82 percent of women failed to check condoms for damage before using them.

Between 0.8 percent and 40.7 percent of participants had experienced a condom break, and between 13.1 percent and 19.3 percent had one leak, depending on the study. Improper condom use, including the wrong kind of lubricant or storage, can contribute to these problems. For instance, oil-based lubricants will degrade latex condoms.

While perfect condom use has a 98 percent success rate at preventing pregnancy, errors can increase the risk of breakage, slippage or other condom failure. Here are the rates for those problems:

Breakage: In various studies, between 0.8 percent and 40.7 percent of participants reported the experience of a broken condom. In some studies, the rates of sex with a broken condom were as high as 32.8 percent.

Slippage: Between 13.1 percent and 19.3 percent of participants reported condom slippage.

Leakage: Condoms leaked in between 0.4 percent and 6.5 percent of sexual encounters studied, with 7.6 percent of men and 12.5 percent of women reporting an experience with a leaky condom.

"Closing the gap between perfect use and the errors characterizing typical use is one of the most crucial challenges of future condom promotion programs," the researchers wrote.

From the study, here are the top condom errors:

1. Late application: Between 17 percent and 51.1 percent of people reported putting a condom on after intercourse has already begun. Other studies found that late application happens in 1.5 percent to 24.8 percent of sexual encounters.

2. Early removal: Between 13.6 percent and 44.7 percent of individuals in the studies had taken a condom off before intercourse was over. Other studies found that early removal happens in between 1.4 percent and 26.9 percent of sexual encounters.

3. Unrolling a condom before putting it on: Between 2.1 percent and 25.3 percent of people reported completely unrolling a condom before putting it on.

4. No space at the tip: Failing to leave a reservoir for semen was reported by between 24.3 percent and 45.7 percent of respondents, depending on the study.

5. Failing to remove air: Almost half (48.1 percent) of women and 41.6 percent of men reported sexual encounters in which air wasn't squeezed from the tip of the condom.

6. Inside-out condoms: Between 4 percent and 30.4 percent of people reported rolling on a condom inside out and then flipping it the other way around, potentially exposing their partner to bodily fluids.

7. Failing to unroll all the way: 11.2 percent of women and 8.8 percent of men had started intercourse before a condom was unrolled all the way.

8. Exposure to sharp objects: Between 2.1 percent and 11.2 percent of people had opened condom packets with sharp objects or otherwise exposed the latex to tearing.

9. Not checking for damage: Meanwhile, 82.7 percent of women and 74.5 percent of men failed to check condoms for damage before use.

10. No lubrication: Between 16 percent and 25.8 percent of participants had used condoms without lubrication, increasing the risk of a break.

11. Wrong lubrication: In about 4.1 percent of sexual events, people used oil-based lubrications with latex, which can degrade the condom. About 3.2 percent of women and 4.7 percent of men reported this error.

12. Incorrect withdrawal: Failing to promptly and properly withdraw after ejaculation was a common mistake, occurring in up to 57 percent of encounters in one study. About 31 percent of men and 27 percent of women reported this error.

13. Condom reuse:  Between 1.4 percent and 3.3 percent of study respondents had re-used a condom at least twice during a sexual encounter.

14. Incorrect storage: Between 3.3 percent and 19.1 percent of people in the studies had stored condoms in conditions outside of the recommendations on the package.

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Flu season is off to a slow start this year.

Influenza activity in the U.S. remained relatively low from October through January — so low, in fact, that the current flu season is considered not to have officially begun until the first week of February, when hospitals reported a slight increase, according to a new report from the Centers for Disease Control and Prevention.

In the last 29 years, the only other flu season to start so late was 24 years ago, during the 1987-88 flu season, the report said.

"This pattern is unusual, but not unprecedented," Dr. Joseph Bresee, chief of the epidemiology and prevention branch at the CDC, said today (Feb. 24) at a news conference about the report.

The majority of flu viruses now in circulation are similar to the ones in this year's flu vaccine, according to the CDC.

"If you haven't gotten you flu vaccine yet, get your vaccine now— it's not too late," Bresee said. Flu vaccination is recommended for t those ages 6months and older in the United States.

Bresee said the late start may, in part, be due to increases in flu vaccination rates. As of November, more people had been vaccinated compared with November 2010, Bresee said. "As vaccine coverage increases, we ought to see less disease in the United States," he said.

In addition, the viruses circulating this year are similar to those of the 2010-2011 season,so there may be higher rates of immunity to the viruses this season, Bresee said. However, these two factors are probably not the sole reasons for the late start.

Researchers cannot predict when flu season will peak or how long it will last. "We can only be certain that flu is inherently unpredictable," Bresee said.

Three children have died of influenza -related illness so far this flu season. Last year, 122 died during the entire flu season.

Since October, hospitalizations for flu have been highest among those younger than 4(2.2 per 100,000 people) and older than 64 (3.2 per 100,000 people).

Flu cases have been reported in all 50 states, but as of Feb. 11, just one of them, California, had reported widespread flu activity, meaning an increase in cases in at least half the regions in the state.

So far, no resistance to the antiviral drugs oseltamivir and zanamivirhas been seen in the strains currently in circulation, the report said.

The report was published Friday in the CDC's Morbidity and Mortality Weekly Report.

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Five months after the first report of listeria infections tied to contaminated cantaloupe, victims of the outbreak continue to die. But just how many isn't clear. 

A lawyer representing those sickened says four more people have died after lingering illnesses linked to eating the tainted fruit last summer. But officials with the Centers for Disease Control and Prevention say the agency has been notified of just two more deaths tied to the outbreak. Those deaths occurred "well before" the agency's Dec. 8 "final" report, but were logged only after, said Lola Russell, a spokeswoman for the CDC.

At that time, CDC reported 30 deaths and one miscarriage related to the outbreak, part of 146 illnesses in 28 states.

The discrepancy may lie in how outbreak-related deaths are reported by state-level officials, Russell wrote in an e-mail.

"It can be unclear whether a death is directly related to infection with listeria when a patient dies many weeks or months after first becoming ill with listeria infection, especially if the patient was elderly or had serious medical conditions that also can lead to death," Lola Russell wrote. "The count of outbreak-related deaths is not final and may still change."

Bill Marler, a Seattle food safety lawyer, said that three of his clients have died in the weeks since the CDC report. They include Paul Schwarz, 92, of Kansas City, Mo.; Sharon Jones, 62, of Castle Rock, Colo.; and Mike Hauser, 68, of Monument, Colo. Dale L. Braddock, 79, of Omaha, Neb., also reportedly died after contracting a listeria infection.

Russell, of the CDC, could not provide the states where the two deaths beyond the 30 the agency has previously counted occurred.

Marler and other food safety lawyers are suing producers and distributors of the tainted fruit, including Jensen Farms of Holly, Colo., where federal inspectors found evidence that poor sanitation, poor storage practices and dirty equipment caused the deadly outbreak. Illnesses were first reported on Sept. 2; recall of the entire crop of cantaloupes soon followed.

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By Karen Rowan
MyHealthNewsDaily

If you want to know whether you’ll lose weight or not, don’t ask a doctor.

In a new study, physicians predicted about 55 percent of patients would be "likely" or "very likely" to follow their recommendations for losing weight, eating healthier or getting more exercise. But three months later, only 28 percent of patients had lost at least two pounds, 34 percent were eating less fat and more fiber, and 6 percent were getting in one more hour of brisk walking each week.  

It was surprising, researchers said, that in slightly more than half of cases, doctors said they believed their patients would follow their recommendations, because other work has not shown that physicians have that level of optimism about their patients' behaviors.

Why the optimism? While physicians generally think patients are unlikely to follow recommendations, after talking with any given patient, doctors become optimistic that the patient will change, the study researchers say.

The findings were published Feb. 7 in the journal Family Practice.

Recordings of doctor's appointments

More than 60 percent of Americans are overweight or obese, according to the Centers for Disease Control and Prevention.

In the study, the researchers made audio recordings of conversations between 40 doctors and 461 of their overweight or obese patients. The doctors and patients knew their conversations were being recorded, but were told only that the study they were participating in would look at how doctors "addressed disease prevention" with their patients — not that weight loss goals would be looked at, specifically.

After each visit, physicians were asked questions such as: How likely will the patient follow your weight loss recommendations?

When considering the patients who the doctors said would likely improve, most of the time, the docs got it wrong. Only 16 percent of those predicted to lose weight actually lost weight over the next three months. Of those that the doctors predicted would follow their healthy eating recommendations, only 19 percent actually improved their eating habits. Four percent of those predicted to get more exercise actually started doing so.

The physicians were more often accurate in their guesses about who not improve.

While previous studies had surveyed physicians about their expectations for their patients in general, none had asked doctors what they thought about specific patients immediately after an office visit, according to the study.

Is optimism good?

Doctors' expectations about their patients ability to change is important, because a doctor with low expectations "can lead to patients being less likely to improve their behaviors," the researchers said. When patients don’t improve behaviors, doctors' expectations only sink even lower, and a vicious cycle ensues.

But physician optimism might have some benefits. "Patients might feel more confident that they can lose weight when they feel their physician believes they will change," the researchers wrote. However, this optimism might mean that the doctors are overestimating the effect their recommendations will actually have on patients, and could make doctors less receptive to learning effecting techniques for counseling patients, according to the study.

Follow MyHealthNewsDaily on Twitter @ MyHealth_MHND. Find us on Facebook.

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Ovarian cancer patients whose treatment was interrupted or even stopped entirely because they couldn’t get supplies of the critical chemotherapy drug Doxil applauded news early Tuesday that federal health officials have found a solution to the shortage.

Food and Drug Administration officials said they have arranged to import temporarily a replacement drug called Lipodox from an Indian manufacturer, Sun Pharma Global.

"That's great. I'm very glad," said Diane Nathanson, 62, of Richmond, Va., who was diagnosed with ovarian cancer in 2006.

“It’s been such a struggle," she said. "Even when I got it, it’s like, ‘Yeah, I got it, but there’s thousands more who didn’t.’”

Nathanson, a retired chef and librarian, had her Doxil infusions postponed twice during recent treatments. On Monday, the drug was available for her, but she learned it was no longer working; a marker for her tumor progression had risen.

“Who knows if it would have worked if I’d had the drug all along?” Nathanson said.

Availability of the new drug is expected to end the Doxil crisis, FDA Commissioner Margaret Hamburg said in a statement released Tuesday.

"Through the collaborative work of FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medications they need," Hamburg said.

This is the second significant drug shortage resolution that the FDA has announced in a week. Last week, officials said they had eased a dire shortage of methotrexate, a chemotherapy drug used to treat childhood leukemia. Ohio-based Bedford Laboratories agreed to release limited supplies of the drug produced before affiliated Ben Venue Laboratories shut down because of manufacturing problems last fall.  

On Tuesday, the FDA also confirmed the agency has granted approval to APP Pharmaceuticals to produce a preservative-free version of the generic drug, the kind most needed to treat acute lymphoblastic leukemia, or A.L.L.

In addition, the agency said it has helped manufacturer Hospira to expedite release of an additional 31,000 vials of preservative-free methotrexate, enough for more than one month's worth of demand. FDA officials are also working with other manufacturers to increase production.

That should help ease the worries of Sara Stuckey of Lincoln, Ill., who was told there was only a week's worth of methotrexate left to treat her 6-year-old son, Nate, who was diagnosed in 2009 with A.L.L.

"It's hard enough to hear your child has cancer, but to hear that the treatment that is successfully working is no longer available is devastating," said Stuckey, who addressed an FDA briefing Tuesday. "My husband I pray that the recommended drug to fight his cancer will be available."

The Doxil move resolves a shortage that has made the drug virtually unavailable since June because of manufacturing problems. The drug is also used to treat multiple myeloma and AIDS-related Kaposi sarcoma.

FDA's Lipodox deal is a temporary, limited arrangement with Sun Pharma Global FZE and its distributor, Caraco Pharmaceutical Laboratories Ltd. The agency has authority to import foreign drugs on a limited basis in rare cases of a shortage of critical drugs.

FDA officials said that they had previously inspected the Indian firm, which already exports the drug to other companies.

The arrangement was first reported by USA Today on Monday.

Patients who need Doxil have been placed on waiting lists, had treatments deferred or have been forced to turn to other, perhaps less effective, regimens as a result of the short supply. Restoring access could be life-saving, said Maggie Heim, 58, of Hermosa Beach, Calif., who posted word of the deal on her Facebook page late Monday.

“Oh, that’s so excellent,” said Heim, a lawyer who has collected more than 800 signatures demanding that the drug’s supplier, Janssen Products LP,  restore the scarce medication. “So I can throw my petition away, I hope?”

Sun Pharmaceuticals Industries Ltd. is based in Mumbai, India, and has a rapidly growing share of the global drug market, according to the firm’s website. Lipodox is a version of doxorubicin hydrochloride liposome injection, which can be used alone or in combination with other drugs to treat cancer.

Doxil and methotrexate were among 287 drugs in shortage in the United States, according to the University of Utah’s Drug Information Service, which has been tracking the problem.

Shortages have been mounting in recent years, up from about 74 in 2005, according to the Utah program.

The escalating problem has caught the attention of Congress, but bills requiring prompt notification of shortages are languishing., advocates say. Last October, President Barack Obama issued an executive order led to a rule that now requires drug makers to report promptly shortages of critical drugs. On Tuesday, the FDA also issued draft guidance to drugmakers on detailed requirements for both voluntary and mandatory notification of issues that could disrupt the drug supply.

Since fall, the FDA has used new information to intervene early with manufacturers to avert shortages of drugs. In 2011, the agency’s efforts avoided 195 shortages, said Erin Fox, who runs the University of Utah drug tracking program. Before the methotrexate and Doxil successes, the FDA already had avoided 18 shortages by the end of January this year.

For patients like Heim, who was diagnosed with stage 3 ovarian cancer in December 2009, the FDA’s effort to replace Doxil is reassuring after months of inaction.

“I’m not sure they do have the tools they need, but someone’s being proactive,” she said. “Having Doxil in the arsenal again is good.”

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Aidan Key, left, was born a girl named Bonnie.

When Aidan Key was a little girl, he didn't realize he had gender identity issues. He simply knew something was off.

"I didn't necessarily become aware that I was trapped in the wrong body," says the 49-year-old Bellingham, Wash., native who had gender reassignment surgery at the age of 33. "I became aware that people didn't perceive me as I felt myself to be. It was just odd to me to have to wear a dress the first day of kindergarten. It didn't make sense."

Today, Key might have received counseling -- and perhaps even puberty blocking drugs -- at one of a handful of U.S. clinics designed to help adolescents with what’s now called gender identity disorder or GID. The psychological diagnosis is used to describe a male or female who feels a strong identification with the opposite sex and experiences considerable distress because of their actual sex (the word "disorder" refers to the distress the person feels, not the fact that they identify with another gender). 

According to reports published Monday in the medical journal Pediatrics, a small but growing number of teens and even younger children who think they were born the wrong sex are now getting support from parents and from doctors who give them treatments that could eventually help them change their sex.

Some estimates say about 1 in 10,000 children may have GID, Dr. Norman Spack, author of one of three reports published Monday and director of one of the nation's first gender identity medical clinics, at Children's Hospital Boston told the Associated Press. And that number does appear to be on the rise, experts say.

The number of people treated at Spack's Gender Management Service clinic, also known as GeMS, which was the focus of a study, increased fourfold between January 1998 and February 2010.  The clinic now averages about 19 patients each year, compared with about four per year treated for gender issues at the hospital in the late 1990s.

While many children can take part in nonconforming gender activities without issue -- little boys playing princess, for instance -- those with GID can experience a host of psychological problems, especially with the onset of puberty.

"It's devastating to them," says Dr. Scott Leibowitz, a child and adolescent psychiatrist at GeMS clinic in Boston.

Those who don’t get support in the form of counseling or medical treatment can be at high risk for behavior and emotional problems, the study found. Of the 97 patients younger than 21 years old in the study who met the criteria for GID, 44.3 percent had a history of significant psychiatric problems, including 20.6 percent who reported self-mutilation and 9.3 percent who attempted suicide. The youngest in the study was age 4.

Laura Edwards-Leeper, a psychologist specializing in youth gender issues at Seattle's Children's Hospital and co-author of the Pediatrics study, says at her hospital, “more and more people are banging down the doors to get in. I'm guessing in part this is due to media attention and people becoming a bit more accepting about it. Parents are becoming more open to the possibility and willing to get help for their kids."

Unfortunately, some parents who seek help for their child through traditional channels - such as the family pediatrician - can come away feeling judged.

"I've heard many, many stories of adults and families being turned away with a stern lecture about their parenting or their choices," says Key, director of Gender Diversity, an education, support and training organization committed to increasing awareness about gender variations. "It can often be viewed as a moral issue."

Support from parents doesn't always exist either, says Key.

"The response varies so much," he says. "Some parents will tell the kids 'No, you're really a boy. No, those are girl toys. You don't want that.' They try to get the child not to engage in these activities because they know it's not accepted by society, they know the child will be teased. I try to think they have the best intentions."

Sometimes, the response of parents -- or others -- can be quite damaging. A related study of childhood abuse in the current issue of Pediatrics found gender nonconformity before age 11 was a risk indicator for physical, sexual, and psychological abuse in childhood as well as probable PTSD.

Chromosomal variations?
Key says there are many theories about why some people have GID but research seems to point to chromosomal variations, i.e., "intersex conditions," such as a female with XY chromosomes instead of XX chromosomes. Another theory has to do with the way a particular person's brain is mapped.

"A person may have a brain that is more oriented towards male and their body is female," he says. "There's been some preliminary research that supports that. But the verdict is still out. They need to do more research on it."

As for what parents should do if their child starts acting in a gender nonconforming way, Key advises ongoing communication and conversations.

"Ask them, 'Do you just want to wear dresses or do you feel like you're a girl?'" he says. "Sometimes a boy who just wants to wear dresses is just a boy who wants to wear dresses."

When little kids speak up and tell their parents "I have the body of a boy but the heart and mind of a girl," though, parents should take note and decide how they want to handle it, he says.

At the GeMS clinic in Boston, a team of psychiatrists, psychologists, endocrinologists, and pediatricians provide tools to help adolescents navigate the choppy social and psychological waters of gender identity.

"As non-transgender individuals, we take for granted how easy life is when our mind and our body are congruent with each other," says Leibowitz. "Clinicians and pediatricians need to understand what gender nonconformity and gender dysphoria mean for a specific individuals and to know there are options out there that will profoundly improve their quality of life."

But even kids who have emotional support can become extremely distressed when puberty hits and their body begins to change into that of a stranger, says Leibowitz.

Learning to fit in
Key says as a child, he had questions that grew sharper as he got older about where he fit in.

Courtesy of Aidan Key

Aidan Key, as a young girl named Bonnie, left, shown with his identical twin sister, Brenda.

"I remember once when I was 9 observing all the families in the lobby at church and realizing that I was supposed to grow up and get married and have a family," he says. "I remember thinking 'I don't mind getting married and having a family, but I don't want to be the wife. I want to be the husband.'"

Key says he received a lot of support from his mother, step-father and identical twin sister, Brenda.

"My family was very encouraging of nontraditional female activities," he says. "I was aware that society expected something different from me but since my family said 'We don't care about that,' I accepted that and said 'It's society's problem, not my problem.'"

Key says he had a couple of boyfriends in high school but by age 19, realized he was attracted to women and began to identify as a lesbian. Over the years, though, he came to realize that that wasn't quite right, either.

"It was challenging," he says. "I was getting all this support to be whatever type of woman I wanted to be, but no one asked what if being a woman wasn't the right part. That was a fixed situation. There was nothing to be done about it."

Today, at the GeMS clinic in Boston, young children and their families get psychological counseling and are monitored until the first signs of puberty emerge, usually around age 11 or 12. Then children are given puberty-blocking drugs, in monthly $1,000 injections or implants imbedded in the arm.

Being able to temporarily push the pause button on puberty (the drug's effect are completely reversible) is extremely helpful, says Edwards-Leeper. The idea is to give these children time to mature emotionally and make sure they want to proceed with a permanent sex change.

"By stopping puberty early on, a boy won't grow as tall, his facial hair won't come in, his Adam's apple won't develop," she says. "All the things that make it difficult for adult transgender people to pass are eliminated. The quality of life for transgender people who have been fortunate enough to receive puberty blocking medication is so much better."

Kids will more easily pass as the opposite gender, and require less drastic treatment later, if drug treatment starts early, Spack said. For example, boys switching to girls will develop breasts and girls transitioning to boys will be flat-chested if puberty is blocked and sex-hormones started soon enough, Spack said.

While many of the patients at the GeMS clinic included in the study were too old for puberty blocking medications, two-thirds did go on to receive cross-sex hormone therapy (i.e., testosterone for women and estrogen for men), which can be a precursor to sexual reassignment surgery. Only one of the 97 in the study opted out of permanent treatment, Spack says.

Not all adolescents with GID opt for the surgery when they reach the age of consent, though, says Leibowitz. "It's very individualized and it's really a private issue. It also isn't covered by insurance and can cost $20,000," he says. "For some people, that might not be a necessary thing."

Key, now married, says his surgery was not only necessary, but a "no brainer."

"Once I had a conscious acknowledgment that I was transgender, it was simply a matter of logistics," he says. "I started saving money. One of the most amazing feelings I ever had was being on a beach without my shirt on and being male and feeling like 'Finally, this is what I'm supposed to feel like.' Normal, natural and right. And about time."

The Associated Press contributed to this report.

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This May 25, 2004 photo provided by The Washington Post shows then-Post reporter Anthony Shadid, in Washington. Shadid died Thursday, Feb. 16, 2012, apparently of an asthma attack, while on assignment for the New York Times in Syria, the paper said. He was 43.

Journalist Anthony Shadid’s sudden death has many wondering how an apparently healthy 43-year-old man could be struck dead by an asthma attack.

No one knows the exact circumstances surrounding Shadid’s collapse, but the New York Times has reported that Shadid, who was on assignment for the paper in Syria, began to show asthma symptoms as he was preparing to leave the country on Thursday and that those symptoms intensified and culminated in a fatal attack.

Times photographer Tyler Hicks, who was with Shadid when the reporter started to have trouble breathing, described the suddenness of the attack.

"I stood next to him and asked if he was OK, and then he collapsed," Hicks told the Times. "He was not conscious and his breathing was very faint and shallow."

Within minutes Shadid had stopped breathing.

Tragic asthma deaths like Shadid’s are more common than they should be, said Dr. James Sublett, a spokesperson for the American College of Allergy, Asthma and Immunology and a managing partner for Family Allergy and Asthma in Louisville, Ky. “The latest numbers are four to five thousand deaths per year,” Sublett said.

In life-threatening situations, something -- often an intense allergic response -- kicks off a severe attack in which the muscles that wrap around airways begin to spasm.

"When that occurs, they can tighten down and stop air from moving in and out," Sublett said.

The scary thing is that it can all happen very quickly, especially if a person’s asthma is not well-controlled. If there is already inflammation in the airways, add triggers like heavy exposure to allergens, stress and physical exertion, and a severe attack can happen.

Hicks speculated that an initial bout of asthma a week earlier was set off by Shadid’s allergy to their guides’ horses. And that apparently was exacerbated as the two walked behind the horses towards the Syrian border the day Shadid died.

It’s possible, Sublett said, that Shadid was exposed to a fatal cocktail of allergens. The journalist might have been allergic to more than just horses. Many people are allergic to mold, and while one doesn’t think of mold as being an outdoor problem, there is a particular type of mold that thrives in the desert. Dust kicked up by the horses might have made things even worse. Reports of soldiers’ having asthma attacks triggered by dust are starting to come out of Afghanistan, Sublett said.

If anything positive could come out of Shadid’s tragic death, it might be heightened awareness of the dangers of asthma, Sublett said.

People often don’t realize that even mild asthma can turn deadly, Sublett said. And because of that, many patients don’t take their condition seriously enough.  They don’t understand that uncontrolled asthma is a ticking time bomb, he said. Severe attacks are far less likely when asthma is controlled.

In the 32 years he’s been practicing, Sublett has seen 3 deaths that he considers to have been entirely preventable. The patients weren’t good about taking their medications on a regular basis and their asthma never got well controlled.

Even when asthma is under control, there’s always the possibility of a flare-up and a severe attack. That’s why Sublett tells his patients that they need to be prepared for the worst -- especially if they are going to be away from medical care.

"Students who are traveling abroad, for example, need to talk to their doctor before leaving and have a plan," he said. "If they’re going to have limited access to medical care they need to take extra medication with them. They need to have steroids and extra inhalers. And they should have an EpiPen and a backup EpiPen."

The EpiPen, a shot that sends a jolt of epinephrine into the body, can abort an attack, Sublett said. But meds aren’t enough.  "They need to make sure their friends know about their asthma and are ready to use the EpiPen," Sublett said.

Related:

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By Karen Rowan
MyHealthNewsDaily

The early signs of autism are visible in the brains of 6-month-old infants, a new study finds, suggesting that future treatments could be given at this time, to lessen the impact of the disorder on children.

Researchers looked at how the brain develops in early life, and found that tracts of white matter that connect different regions of the brain didn't form as quickly in children who later developed autism, compared with kids who didn't develop the disorder.

"The way the wiring was changing was dampened" in the children with autism, said study researcher Jason Wolff, who studies developmental disabilities at the University of North Carolina, Chapel Hill. "It was a more blunted change over time, in how the brain was being wired."

In contrast, in the brains of infants who did not later develop autism, white matter tracts were swiftly forming, Wolff said. "Their brains were organizing themselves in a pretty rapid fashion."

The findings suggest that during a child's first year, "there is a potential to intervene, to disrupt autism before it becomes entrenched," Wolff said. "There are a lot of possibilities to improve outcomes for these children."

The study was published Friday in the American Journal of Psychiatry.

The first year of life is an important time in brain development, and is also when the first symptoms of autism start to appear, Wolff said.

In the study, the researchers looked at the brains of 92 infants, when they were 6 months, 1 year and 2 years old. All of the children had a sibling with autism ; research shows such children have a higher risk of developing the disorder themselves.

The researchers used a brain scan called diffusion tensor imaging, a type of MRI scan which allowed them to see changes in the brain's organization over time.

When the kids were 2 years old, 28 had developed autism, while 64 had not. The researchers looked back at the early brain scans, to see if there were differences between the groups.

"We looked at pathways that connect brain regions to each other, and 12 out of 15 were different in kids with autism," Wolff said.

Previous studies had found differences in brain volume in infants of this age, and other researchers had looked at white matter tracts in older children with autism, and adults, but the structures had not been examined before in infants so young, Wolff said.

The fact that so many of the tracts were affected shows that autism is a "whole-brain phenomenon," Wolff said. "There are widespread differences" in the brains of people with the disorder, he said.

Twins with autism: Parents wonder, did it have to happen?

As to what might be causing these brain differences, it's too early to say, Wolff said. But the findings are consistent with what researchers suspect about what triggers autism's development, he said, "there's a complex interaction between genes, and a child's experiences with the world."

And while the brain scans of the two groups of children certainly revealed their differences, those scans are not at the point where they could be used to diagnose the disorder in a 6-month-old, Wolff emphasized.

But the findings help researchers better understand how the disorder develops.

"It was really important to see that this was an evolving process," Wolff said. Kids don't just suddenly become autistic, "getting there is a journey," he said.

The researchers will continue to follow some of the children in the study until they are 3 years old, and will continue to enroll more children in the study, Wolff said. 

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An Ohio drugmaker began releasing limited supplies of a crucial medication to treat childhood leukemia Thursday, sending hospital pharmacists facing life-threatening shortages scrambling for their share.

Jerrod Milton, chief of pharmacy at Children’s Hospital of Colorado, was among those first in line as Ben Venue Laboratories began accepting new orders for the drug methotrexate, three weeks before the hospital would have run out completely.

“I had a tip that it was going to be available,” he said. “I put my pharmacy team on notice.”

Ben Venue officials said product would be allocated starting now and continuing over the next several weeks to oncology clinics, hospitals and pediatric facilities, easing the shortage crisis. No information was available about which sites would get the scarce drugs first, or in what order.

Milton is awaiting the arrival Friday of what he hopes will be 300 250-milligram vials of the widely-used drug to treat acute lymphoblastic leukemia, known as A.L.L., a blood cancer that mostly affects young children. It's a virulent cancer of the white blood cells that spreads to other parts of the body.

The drug is short-dated, meaning it is set to expire in two weeks, but Milton is requesting it anyway to replenish vital supplies of the medication that makes A.L.L curable in about 90 percent of cases, cancer doctors say. The amount and timing of the drug used varies widely according to age, weight and other patient factors. The Colorado hospital has dozens of patients on the protocol.

“It extends our supply by essentially up to a month,” said Milton, who is also his hospital’s vice president of operations. “But it’s still a very uncomfortable place to be.”

News this week that hospitals across the country were within a couple weeks of running out of the critical drug prompted herculean negotiations involving the federal Food and Drug Administration and the five manufacturers of methotrexate. The story was first reported in the New York Times.

Chuck Eaton, facesofhope.org

Justine Seibel, 13, of Fort Mill, S.C., is among thousands of children with acute lymphoblastic leukemia, or A.L.L., who are treated with the cancer drug methotrexate. Reports of dire shortages worry her mother, Christine Farinick.

It also prompted anxiety and anger for parents like Christine Farinick of Fort Mill, S.C., whose 13-year-old daughter, Justine, was diagnosed with A.L.L. a year ago. She has received dozens of treatments of methotrexate and is scheduled for another session in three weeks -- as long doctors can get it.

“Without it, there’s a high rate of relapse,” said Farinick, who is getting a passport and researching ways to obtain methotrexate from suppliers in Europe and Canada if she can’t obtain it in the U.S.  “It is available.”

Bedford Laboratories, which runs Ben Venue, worked with the FDA to arrange allocation of strictly limited supplies of the drug. The product was produced before the troubled firm voluntarily shut down its operations in November because of manufacturing and quality problems identified during FDA inspections.

“We hope this supply will help address near-term patient needs while other companies licensed to manufacture methotrexate increase production,” Ben Venue officials said in a statement.

The four other manufacturers of the drug -- Hospira Inc., Mylan Institutional, Sandoz and APP Pharmaceuticals LLC -- indicated they were trying to increase production or work with the FDA to allow production of the preservative-free version of the drug. Methotrexate without preservative is given intravenously or injected into spinal fluid, where preservatives could cause toxic reactions.

Neither Bedford officials nor the FDA would say how much product is available, or how many hospitals would be served.  Hospital buyers say they’re being quizzed about patient need and allowed a two-week supply of the drug, said Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages.

The new availability is both a relief and a reminder of the seriousness of drug shortages that now number about 287, the most in U.S. history, cancer experts said.

“Every little bit helps, but it’s so wrong that we have to live like this,” said Dr. Harvey Cohen, a professor of pediatrics at the Stanford School of Medicine and a member of the American Society of Hematology’s government affairs committee. After decades of progress in finding the right drugs to treat -- and cure -- A.L.L., not being able to obtain them is a huge setback, Cohen said.

He was waiting to hear Thursday whether he would get an order of 20 grams of methotrexate to treat a 16-year-old boy with a bone tumor on Friday.

“His tumor responded beautifully to the medicine. We know the medicine works,” Cohen said. “We have the orders in. I signed them myself yesterday. I just don’t know if we will get it.”

Cohen said he and his colleagues essentially have to ration the drug, giving highest doses to children with difficult-to-treat cancer and lower doses to those whose condition is easier to treat.

"Given the shortage, we have to be able to give that to the children who will benefit the most," he said.

Some experts are breathing a brief sigh of relief at the stop-gap supplies of methotrexate. Dr. Michael Link, president of the American Society of Clinical Oncology, praised the FDA’s efforts to avert a total shortage.

“The FDA deserves a fair amount of credit for really stepping up to the plate and resolving this for the short term,” he said. “It’s unfortunate that we had to get to a crisis situation.”

Five U.S. senators demanded more information about the problem on Thursday, sending a letter to Ben Venue officials saying patients and providers have been given no timeline for fully resolving the crisis. They asked for more information about the quality problems at Ben Venue that prompted the shutdown, stalling production not only of methotrexate, but other drugs in short supply. The senators asked if reimbursements for the drug, which is a low-profit generic, played a role in the current shortage.

That echoes the concerns of Christine Farinick, who said she believes that low returns are at the root of the problem.

"All the medication shortages are because the drugs are not profitable to make," she said, adding: “I think that’s absolutely disgusting." 

Related stories:

Amid shortages, rules force hospitals to trash scarce drugs

Lingering shortage of ADHD drugs unravels lives

The FDA has issued a warning about Spinbrush toothbrushes, such as those shown here. Parts have flown off during use, causing cuts and chipping teeth.

The U.S. Food and Drug Administration issued a consumer safety update Thursday about a brand of electric toothbrushes that's been found to chip teeth, cut gums and generally wreak havoc with your face.

Injuries reported from use of the battery-powered Spinbrush toothbrush, sold by both Arm & Hammer and Crest (before 2009), include chipped or broken teeth, cuts to the mouth and gums, injuries to the face and eyes and choking hazards thanks to broken pieces.

According to a consumer safety officer at the FDA, reports indicate that parts of the toothbrush have broken off during use, causing them to be "released into the mouth with great speed, causing broken teeth and presenting a choking hazard."

The Spinbrush, manufactured by Church & Dwight Co., Inc., comes in both adult and children's models under the following names: Spinbrush ProClean; Spinbrush ProClean Recharge; Spinbrush Pro Whitening; Spinbrush SONIC; Spinbrush SONIC Recharge; Spinbrush Swirl; Spinbrush Classic Clean, and Spinbrush for Kids.

All have the potential for injury, according to the FDA.

The adult Spinbrush model has a brush head that is removable and can be replaced. However, the brush head has popped off in some cases, exposing metal pieces that have poked users in the cheek and eye areas, causing injuries. The child's model, Spinbrush for Kids (which includes Spiderman and Thomas & Friends designs), does not come with a removable head, however, it, too, has caused problems, including cut lips, burns from the batteries, and bristles which have fallen off and lodged in a child's tonsils.

“We are particularly concerned about the problems with these toothbrushes as they appear to be geared towards children,” said Dr. Susan Runner, branch chief for Dental Devices in the FDA’s Center for Devices and Radiological Health. “The hazards that have been reported are potentially very serious, and parents should be aware of helping young children with tooth brushing both for safety reasons and for assuring adequacy of brushing.”

Last year, the FDA issued a warning to Church & Dwight Co Inc. based on an inspection which found numerous consumer complaints about the product that had not been reported to the agency. The manufacturer responded to the FDA warning by improving its labeling to caution consumers about changing the brush head after three months; adding bristles that changed color to help reminder consumers to swap out the brush head and issuing a safety notice in TV and print ads which warns that if the brush head is not replaced after three months' use or becomes damaged or loose that it "could lead to brush head breakage, generation of small parts and possible choking hazard."

In the safety alert issued today, the FDA advises parents, caregivers and consumers to inspect the Spinbrush before use for loose or damaged brush bristles and to make sure the brush head is connected tightly to the brush handle. If the brush head or bristles are loose (or damaged), the FDA says the Spinbrush should not be used and the issue should be reported to the manufacturer at 1-800-352-3384 or 1-800-561-0752.

In addition, the FDA advises Spinbrush users to never bite down on the brush head while brushing and to follow all instructions and recommended replacement guidelines for the product.

The FDA also recommends that anyone suffering an injury or problem with the Spinbrush contact the FDA's Safety Information and Adverse Event Reporting Program by calling 1-800-332-1088 or using going to the website. 

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