Current Events in February 2011

The U.S. Food and Drug Administration (FDA) has approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.

The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth.

Accelerated approval

Approval was granted under FDA's accelerated approval regulations that allow promising drugs to be approved based on a surrogate endpoint benefit -- in this case, reducing the risk of delivery before 37 weeks of pregnancy -- that is reasonably likely to predict a clinical benefit.

Under these regulations, the manufacturer must conduct additional studies after the product is approved to demonstrate that the drug does, in fact, have a clinical benefit.  An international trial is ongoing to learn if there is also improvement in the outcome of babies born to women given Makena.

Such outcomes include reducing the number of babies who do not survive or who suffer serious health problems shortly after birth.

Major health concern

“Preterm birth is a significant public health issue in the United States,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “This is the first drug approved by the FDA that is indicated to specifically reduce this risk.”

A health care provider would give Makena once a week by injection into the hip. Treatment should begin at 16 weeks and no later than 21 weeks of pregnancy.

Study specifics

The FDA reviewed data on the safety and effectiveness of Makena in a multicenter randomized double-blind clinical trial. The study included 463 women 16 to 43 years of age who were pregnant with a single fetus and had a history of a prior spontaneous preterm birth. Among women treated with Makena, 37 percent delivered early (before 37 weeks) as compared with 55 percent of women in the control group.

A separate study evaluated the development of children born to mothers enrolled in the controlled trial. In this study, children ages 2.5 years to five years reached similar developmental targets, regardless of the mother’s treatment.  The confirmatory study that is underway will be followed by a similar infant follow-up study, to be completed about 2018.  That study is expected to include 580-750 infants, depending on the number of study sites and mothers willing to participate.

The most common side effects reported with Makena included pain, swelling, or itching at the injection site; hives, nausea and diarrhea. Serious adverse reactions were rare; there was a single report each of blood clot in the lungs (pulmonary embolism) and an infection at the injection site.

The FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women. The approved indications include threatened miscarriage. The original manufacturer requested the withdrawal of Delalutin from the market in 2000 for reasons unrelated to safety.

Consumers and health care professionals are encouraged to report adverse events from medications to the FDA's MedWatch program at 800-FDA-1088 or online.

The government has regulations for the kinds of information that must be displayed on meat labels, but high-end supermarket chain Whole Foods Market says it's adding to the information available to consumers.

These labels will carry information -- not about nutrition -- but how the animals were raised before slaughter. Whole Foods says the 5-Step Animal Welfare Rating System is the signature program of the Global Animal Partnership, a nonprofit organization that facilitates and encourages continuous improvement in animal agriculture.

Independent, third-party certifiers audit farms and rate animal welfare practices and conditions using a tiered system that ranges from Step 1 (no crates, no cages, no crowding) to Step 5+ (animals spend their entire lives on one farm). The company says the system provides a way to engage and reward producers by promoting continuous improvement in farm animal welfare. For shoppers, the rating system provides a way to make more informed choices at the meat counter.

The five steps in the ranking system are:

• Step 1: No cages, no crates, no crowding

• Step 2: Enriched environment

• Step 3: Enhanced outdoor access

• Step 4: Pasture centered

• Step 5: Animal centered; no physical alterations

• Step 5+: Animal centered; entire life on the same farm

Third party certifiers

More than 1,200 farms and ranches providing the company's 291 U.S. locations with products have received Step certification through independent, third-party certifiers, Whole Foods said. Color-coded signs and stickers throughout Whole Foods Market meat departments identify these ratings.

"In my 20 years of working with ranchers and farmers, this is the largest commitment to improving farm animal welfare that I have seen," said Anne Malleau, global animal production and welfare coordinator for Whole Foods Market. "Producers need to meet approximately 100 requirements to get a Step 1 certification, so achieving the first level is a remarkable accomplishment. Whole Foods Market is able to adopt the 5-Step Animal Welfare Rating System thanks to the true partnerships we have with our producers who put just as much emphasis on the lives of their farm animals as they do on ensuring high-quality products."

All meat sold at Whole Foods Market must meet the company's strict quality standards, which require that animals be raised on a vegetarian diet without being administered antibiotics or added growth hormones. Step-rated options are now available at all U.S. Whole Foods Market stores and by May 9, all beef, pork and chicken carried in the fresh and pre-packaged cases will be rated according to 5-Step Animal Welfare Rating standards, the company said.

A new report from the American Cancer Society says cancers associated with lifestyles and behaviors related to economic development -- including lung, breast, and colorectal cancers -- will continue to rise in developing countries if preventive measures are not widely applied.

The finding comes from the second edition of Global Cancer Facts & Figures and its academic publication, Global Cancer Statistics, published in CA: A Cancer Journal for Clinicians. Both publications were released on World Cancer Day, Feb. 4, 2011. 

Increasing cancer

According to estimates from the International Agency for Research on Cancer (IARC), there were approximately 12.7 million new cancer cases worldwide in 2008 -- 5.6 million of which occurred in economically developed countries and 7.1 million in economically developing countries.

There were approximately 7.6 million cancer deaths worldwide in 2008, 2.8 million of which occurred in economically developed countries and 4.8 million in economically developing countries. By 2030, the global cancer burden is expected to nearly double, growing to 21.4 million cases and 13.2 million deaths.

And while that increase is the result of demographic changes -- a growing and aging population -- it may be compounded by the adoption of unhealthy lifestyles and behaviors related to economic development, such as smoking, poor diet, and physical inactivity.

Preventable deaths

An accompanying editorial (appearing in CA:) by Otis W. Brawley, M.D., chief medical officer of the American Cancer Society, says about 2.6 million of the 7.6 million cancer deaths that occurred in 2008, or about 7300 cancer deaths per day, were potentially avoidable through the prevention of known risk factors, including tobacco use, dietary factors, certain infections, and alcohol use.

"The worldwide application of existing cancer control knowledge according to the capacity and economic development of countries or regions could lead to the prevention of even more cancer deaths in the next 2 to 3 decades," writes Dr. Brawley. "In order to achieve this, however, national and international public health agencies, governments, donors, and the private sectors must play major roles in the development and implementation of national or regional cancer control programs worldwide."

Cancer rate comparisons

A comparison of cancer rates reveals differences in cancer causation between economically developed and economically developing countries. In economically developed countries, the three most commonly diagnosed cancers in 2008 were prostate, lung, and colorectal cancers in men and breast, colorectal, and lung cancers in women. In economically developing countries, cancers of the lung, stomach, and liver were most frequently diagnosed in men while breast, cervical, and lung cancers were the most commonly diagnosed in women.

Two of the three leading cancers in men (stomach and liver) and one of the three leading cancers in women (cervix) in developing countries are related to infection. Overall, about one in four cancers in developing countries are related to infection compared to fewer than one in ten in developed countries.

Shifting trends

The report also outlines shifts in cancer trends that point to the increasing impact that unhealthy behaviors are beginning to have in developing countries. While male lung cancer death rates are decreasing in most Western countries, they are increasing in China and several other countries in Asia and Africa where the tobacco epidemic is in earlier stages and smoking prevalence has not begun to drop, or even continues to increase.

Lung cancer rates in women, which have plateaued in the US, are increasing in many countries, notably in Spain, France, Belgium, and the Netherlands, where rates are up among younger women -- suggesting lung cancer in females in these countries will likely increase for several decades barring major interventions.

Breast cancer is now the leading cause of cancer death among females in economically developing countries, a shift from previous decades during which cervical cancer was the most common cause of cancer death. Colorectal cancer incidence rates, which have been decreasing in the US, are rapidly increasing in several countries historically at low risk, including Spain and a number of countries within Eastern Asia and Eastern Europe.

Having your company's name mentioned in the same sentence with Bernie Madoff probably isn't going to be good for business. But that's the situation now facing one of America's largest banks, JPMorgan Chase.

A lawsuit unsealed in New York last week claims that while Madoff was running his Ponzi scheme, taking in billions of dollars, Chase was "at the very center" of the fraud and was "thoroughly complicit" in it.

According to the complaint, JPMorgan Chase had reason to look the other way. It claims the bank earned a half-billion dollars in its relationship with Madoff -- money that ultimately came from the pocket's of Madoff's victims. It further claims many of the bank's executives strongly suspected Madoff's enterprise was fraudulent, but said nothing.

The suit was filed in December by Irving Picard, a bankruptcy trustee for Madoff's victims, who is trying to reclaim as much money as possible. The suit was sealed at the bank's request. In a separate suit, Picard accused New York Mets owner Fred Wilpon was involved in financial dealings with Madoff and knew about his scheme.

Speculation about a Ponzi scheme

Among the documents contained in the complaint against Chase is an internal document from JPMorgan Chase's Hedge Fund Underwriting Committee. It quotes one member of the committee saying that Madoff's returns looked suspicious. The member even said that there was speculation within the bank itself that Madoff could be part of a Ponzi scheme.

Madoff, a highly respected and longtime Wall Street player, was arrested in December 2008 and charged with running a $50 billion Ponzi scheme. Madoff, a former chairman of the Nasdaq Stock Market, deceived wealthy investors who thought they were reliably earning two percent or more per month on their money even when financial markets were performing poorly.

The 73-year old Madoff is currently serving a 150-year prison sentence.

'Meritless'

Meanwhile, JPMorgan Chase issued a statement, calling the complaint "meritless" and based on distortions.

"Contrary to the trustee's allegations, JPMorgan did not know about or in any way become a party to the fraud orchestrated by Bernard Madoff," the company said in a statement. "Madoff's firm was not an important or significant customer in the context of JPMorgan's commercial banking business, and the revenues earned from Madoff's bank account were modest and entirely consistent with conventional market rates and fees."

Valentine’s Day, Feb. 14, is quickly becoming a holiday where consumers are urged to spend money on stuff: candy, cards, flowers, home décor, baking supplies, clothing. You name it, one of your favorite stores has a huge section chock full of inexpensive little things for people to stock up on.

Like many holidays, its celebration can create unintentional environmental side effects, such as the consumption of natural resources and the generation of solid waste.

But that doesn’t have to be the case.

When celebrating Valentine‘s Day, Americans tend to go all out. For example:

• 198 million roses: The number produced for Valentine’s Day in 2010, according to the Society of American Florists.
• 141 million Valentine’s Day cards: The number exchanged each year (not including packaged kids’ Valentines for classroom exchanges), according to Hallmark. This makes Valentine’s Day the second-largest holiday for giving greeting cards.
• $14.1 billion: The amount Americans were expected to spend on traditional Valentine’s Day merchandise in 2010, according to a survey conducted by the National Retail Federation.

For consumers trying to cut their carbon footprint, these figures are unsettling. But that doesn’t mean you can’t participate in February 14 like everyone else.

“It is possible to have a special, perhaps even more creative and memorable than usual, Valentine’s Day celebration while still being environmentally responsible,” said Kendra Abkowitz of the Vanderbilt University Sustainability and Environmental Management Office.

Here are some of her suggestions for having a planet-friendly holiday:

Send an e-Valentine in lieu of a paper Valentine
Hallmark and 123 Greetings are some of the many websites offering an electronic Valentine service. If sending a paper Valentine, be certain to send one that is printed on paper containing recycled-content. Don’t forget to recycle Valentines you have received that you aren’t keeping!

Choose flowers carefully
Give organic or locally grown flowers, a potted plant, a tree seedling or a perennial plant instead of the traditional bouquet of flowers.

Give organic or fair-trade chocolates
Organic chocolates are produced in an eco-friendly manner without the use of pesticides, and fair-trade chocolates ensure that cacao farmers work in healthy, sustainable and safe environments while receiving a fair wage for their products. Organic chocolates are also a good way to cut out the chemicals and fillers some manufacturers rely on to make their sweets on the cheap. Some organic and fair-trade chocolate choices include Trader Joe’s, Equal Exchange and Dagoba.

Make a donation to an environmental organization on behalf of your Valentine
Several organizations you might consider are the World Wildlife Fund, the Sierra Club and the Arbor Day Foundation.

Plan a trip to a wildlife reserve, park or natural area
Your business will help support the running of such establishments. Several destinations you might consider include your local state parks, U.S. Fish & Wildlife Service refuges and U.S. National Parks.

Go local for dinner
Arrange dinner at a local restaurant that specializes in organic or locally grown food, or make your own romantic meal with locally grown ingredients. Eating locally reduces the number of miles that your food travels to you and supports local establishments. Cooking your own meal will also save gas and money while avoiding greenhouse gas emissions.

Commit to going green at work and home
Several easy ideas include turning lights off when leaving the room, shutting down your computer at the end of the day, creating a dedicated home recycling area, washing only full loads of dishes and laundry, moderating your thermostat when leaving your house or office for extended periods of time, unplugging appliances not in use and printing or using both sides of paper when possible. (This last tip is a way to say “I love you” to the Earth on any day, not just February 14!)

Comcast has agreed to pay $23 million to Oregon consumers who said their late fees were excessive under that state’s law.

Under the terms of the settlement, affected consumers will receive $16 per illegal late fee, up to $32. Consumers who say they were charged more than two illegal late fees must present proof, such as a receipt or a cancelled check. Consumers can also collect more than $32 if they sign a notarized oath attesting to the numerous late fees. Comcast will also donate $75,000 to the Oregon Food Bank and the United Way.

Up to 75,000 Oregon consumers may be able to collect under the agreement.

Suit covers seven-year span

The suit, which was filed in Multnomah County Circuit Court, was certified as a class action last March, and proceeded on behalf of “all current and former Oregon residents who: 1) are or were Comcast cable television subscribers in Oregon after July 14, 2003 and 2) who, during the class period, paid a late fee responsive to a billing from Comcast that did not comply with [Oregon law].”

The settlement covers consumers who were charged excessive late fees between July 14, 2003 and November 22, 2010.

Economic Fairness Oregon, a consumer advocacy group based in Portland, predicted on its blog that “a large portion of this $23 million settlement will go unclaimed. Under current Oregon law, the remaining money will be returned to Comcast, despite the company’s alleged wrongdoing.”

“This case is a prime example of a company raking in huge amounts of money by unfairly charging tens of thousands of customers a relatively small amount,” the group continued. “Since many customers don’t have the time to challenge each $6 late fee, Comcast was able to overcharge millions of dollars in late fees from Oregonians over the span of the last seven years ... Thanks to class-action suits such as this, Comcast and other companies that choose not to play by the rules are held financially accountable for deceiving their customers.”

Liability denied

Comcast denied any liability in settling the suit, but “concluded that it is in the best interest of Plaintiffs and the Settlement Class ... to enter into [the] Settlement Agreement.” In a written statement, an Oregon representative of the company wrote that Comcast “denies liability and maintains that the late fees are legal.”

 Claim forms can be found at the official settlement website.

Consumer complaints

 ConsumerAffairs has heard from several Comcast customers complaining of late fees. As Marissa of Miami wrote:

"First off, I was already a Comcast customer but moved to a new location and they charged me another service of installation fee to have my service switched to the new address. Second, I set up automatic bill pay but for some reason it wasn't working. I was charged a $5 late fee for not having my payment in on time. When I spoke to Comcast they apologized and gave me a credit on my next bill. They assured me that automatic bill pay was set up properly but that sometimes it takes a couple of months to work.

"The next month the same thing happened. I had to go through the same process of calling them to credit my account. Again, they assured me it was set up properly and to just wait one more month. The same thing happened for a third time and I quit trying to use the automatic bill pay. They did credit my account but I had to spend time waiting on the phone and explaining the situation every time."

In today’s shaky employment climate, if you have a job, you might be forgoing all else in order to keep it. While cutting back on sleep and healthy eating is known to cause any number of physical maladies, a New York professor says cutting back on leisure activities can be just as damaging to health -- mental and physical.

Dr. E. Christine Moll, a professional counselor, professor of counseling and human services at Canisius College, and “leisure expert,” says “play-time” is as important to a person's health as keeping cholesterol levels in check and getting regular exercise.

"It airs out our brain. It renews our spirit. It gives us clarity of thought. It's a benefit to our blood pressure. It gives us life satisfaction. For all the dimensions of our lives: our physical, mental, spiritual and cognitive health " leisure time should be a necessity not a luxury," said Moll.

Moll teaches students and professionals about the necessity for leisure -- anything that brings personal enjoyment to individuals and allows them to recharge their batteries -- in their lives.

"Work is the single activity we do most in our lifetimes. We work more than we sleep or eat," said Moll. "Our health and medicine are so much more improved than they were a century ago but we're going to wipe ourselves out because we're just working, working, working."

Moll notes the biggest abusers of the all-work-and-no-play lifestyle are Baby Boomers.

Biggest abusers 

"This generation really pushes to gain the American Dream and thinks nothing of putting in long hours or forgoing vacations for only long weekends," she said. "They often find it hard to put the breaks on, catch their breath and relax."

Moll's colleague, David L. Farrugia, PhD, chair of the Counseling and Human Services Department at Canisius and a professional counselor, said by the time patients come to him, many have already visited their primary doctor for anxiety-like symptoms. Stress is often the culprit.

"Physiologically, the body is able to adapt and function at high levels of stress but eventually it begins to take its toll on a person's mental and physical health," said Farrugia.

In the professional world, this condition is known as general adaptive syndrome (GAS), first identified by Hans Selye, MD, who pioneered stress research and is known internationally as the "father of the stress field."

If physical concerns aren't enough to provoke people to make time for play, Moll recommends focusing on the long-term benefits of leisure.

Under Moll's guidance, Canisius alumna Summer M. Reiner examined the pivotal role leisure can play throughout a person's life.

"Findings show that people who nurture leisure activities throughout their lives have a much healthier outlook physically, mentally, emotionally, socially and in their sense of selves,” said Reiner.

Reiner found children who actively participate in leisure activities tend to grow into confident, active and satisfied adults.

"Extra-curricular activities for school-aged children contribute a lot towards their development," says Reiner, whose research was published in Counseling Today magazine.

Stay out of trouble

According to Reiner, kids with active extra-curricular interests tend to stay out of trouble, be more excited about school, have higher grades, more confidence, and are able to enhance their social, physical and intellectual skills. Overall, they exhibit better mental health.

According to Moll, they also learn where their interests lie and that information can be useful for parents and teachers.

"If we can help young people identify what they like doing for leisure, we can help them turn those interests into productive careers," said Moll.

But she adds, much like their Baby Boomer parents, today's young working adults can easily fall into the trap of not leaving themselves enough free time.

Reiner's research also found parents who nurture their leisure lives tend to manage stress better and are more prepared to handle "empty nest syndrome." Equally important is that parental leisure promotes family stability and serves as a model for a healthy, balanced lifestyle for children.

"Children who witness their parents enjoying hobbies and activities outside of work grow up to value the benefits of leisure themselves," says Reiner. But she warns that parents should not trick themselves into thinking their children's activities count for their own leisure.

"Many parents say that's their enjoyment, watching their child's baseball or soccer game. But that is an aspect of parenting, not leisure. Parents need to develop their own leisure interests."

Developing and nurturing interests early can even help people live healthy, productive lives once they reach old age.

Without the responsibilities of a job or children, it's common for people at this stage of life to experience an identity crisis.

But Moll said retirees who embrace leisure throughout their lives are less likely to lose that sense of self when they stop working. For those who stay active throughout their Golden Years, leisure provides structure to what appears to be an unstructured day.

"It keeps them more mentally aware, emotionally connected and physically capable. Their pastimes give them a sense of independence and competency, even as they may be losing some of their other skills," said Moll.

What's lacking 

So how does one add leisure time to a seemingly packed daily routine? Moll says the first step is to determine how much leisure time is lacking.

"If you can't remember the last time you took time for just you, it is time for a change," she said. "What have you done for yourself, lately? When was the last time you did something just for fun or just for the health of it? If your answer is 'I read a book a year ago,' then you need to do more. Whether it's cooking, needlework, golfing or whatever, put leisure into your life. It's important."

Moll advises that once the commitment is made to make a chance, it's time to reconnect with favorite pastimes. Not surprising, many people are so far removed from recreation they have forgotten what they once enjoyed.

If you fit this profile, Moll recommends a few things: Spend time at the library to find out where your interests lie. Stroll the aisles at craft or sporting good stores for promising new hobbies. Talk with people about what they like to do for fun.

"It's like food, you have to taste different things to find your passion. The greatest indicator of your leisure interests as an adult can be found in your youth. The whole idea of recreation is re-creation," said Moll.

Leisure can include anything from a crossword puzzle to a pickup game of basketball, as long as it fits the following criteria: The activity must be freely chosen by the participant; provide satisfaction and adventure; arouse interest; require a commitment; serve as a sense of separation or escape; and most important, be pleasurable.

Moll warns that competition is not part of the leisure game.

"If you didn't win that tennis match or were only able to bike two miles instead of three, that's ok. What is important is that you're relaxing. But if you get so wrapped up in winning that your blood pressure goes up or you make others around you miserable, that's not leisure. Yes, you can be sweaty or exhausted when you're finished doing whatever you were doing but for the purpose of being helpful, leisure needs to be restful."

Leisure also needs to be practiced, practiced, practiced.

According to Moll, too many of us don't recognize an opportunity when it comes along. But a little downtime gives our brains a much-needed break.

"Leisure is a lot like having a 'runner's high,'" she said. "Our endorphins kick in, our heart rate changes, our blood pressure changes and our emotional well-being gets a time out. A little personal play time can also go a long way in our relationships. I tell my counseling students this all the time: We can't give what we don't have. We can't give to our family, friends, students or clients if we don't first take some time for ourselves."

Moll adds, "It doesn't matter what you do or that you may not do it well. Just start slowly and fake it until you make it. The point is to get out there, relax and appreciate the grandeur of the world once in a while. Play with abandon. Live life with intention. And be gentle with yourself."

As families get ready to watch the Super Bowl tomorrow, what else will they see besides touchdowns and field goals?

Ads promoting alcohol and other products geared toward an older audience.

Christy Buchanan, professor of psychology at Wake Forest University and an expert on parent-child relationships, says parents shouldn’t squirm on the couch until each round of beer ads is over, but should take action.

They can turn uncomfortable moments in front of the TV into “values moments” with their children.

“It is important for parents to address issues and share their values. So, when beer commercials come on, talk about your views on drinking. There are so many societal messages that say ‘drinking makes life fun.’ This is a parent’s opportunity to say what they think and start a discussion,” said Buchanan.

Professional football is by far the most popular sport to watch among kids; 66% of kids ages 7 through 11 say they watch pro football on television.

A study by the non-profit group Common Sense Media reviewed nearly 6,000 commercials in 60 NFL games in a recent season and found they were generally anything but kid-friendly:

• 300 of the ads were for alcohol
• 40% of the games included advertisements for erectile-dysfunction drugs
• 500 of the advertisements involved significant levels of violence, including gun fights, explosions, and murders
• 80 of the advertisements involved significant levels of sexuality, including scenes about prostitution and strippers

With these figures in your mind, you might be worried you’ll have to miss the game all together in favor of shielding your kids from potentially salacious advertisements, but you don’t have to be.

“I do think that doing things like the Super Bowl can be ‘family bonding’ events despite the commercials,” said Buchanan.

She offers some easy tips for parents trying to figure out what to do when a kindergartner asks, “What’s Viagra?” or a teenager comments on how much fun people are having in a beer commercial:

• Take a “values moment”: Leave the TV on, but talk about family values. For older children (middle school age and up), use the opportunity to engage children in conversation, particularly about issues such as drinking.
• Ask children what they think about what they are seeing or hearing, then respond to their perceptions and reactions.
• Switch channels and find another show: For younger children, hit the previous channel button to Animal Planet or “Sponge Bob” on the remote control. Go back to the game in two minutes.
• Mute the TV: Without the sound, commercials lose a lot of their impact. Use this time to talk about what’s happening in the game.

The part-time job is a rite of passage for most teens. Some are encouraged to work so they'll stop badgering Mom and Dad for money. Others want to save up for college. And with unemployment rates still high in America, many teens work part-time during the school year in an effort to help out with family finances.

But caution is advised: Among high school students, working more than 20 hours a week during the school year can lead to academic and behavior problems.

That's the finding of a new study by researchers at the University of Washington, University of Virginia, and Temple University.

In a reanalysis of longitudinal data collected in the late 1980s, researchers examined the impact of getting a job or leaving work among middle-class teens in 10th and 11th grades.

Drawing from the full sample of about 1,800 individuals, the researchers compared teens who got jobs to similar teens who didn't work, and teens who left jobs to similar teens who kept working.

Using advances in statistical methods, the researchers matched the teens on a long list of background and personality characteristics known to influence whether or not a young person chooses to work.  Using this technique allowed more certainty in estimating the effects of working on teens' development than in the original analysis of the data.

Less engaged 

The researchers found teens who worked more than 20 hours a week were more likely to be less engaged in school, less likely to excel in school, and more likely to fall victim to problem behavior like stealing, carrying a weapon, and using alcohol and illegal drugs.

They also found things didn't get better for those teens when they cut back on work hours or quit working altogether.

However, families in desperate need to extra income, regardless of how much need not worry -- working 20 hours or less a week seemed to have no academic, psychological, or behavioral effect on teens.

Kathryn C. Monahan, a postdoctoral research scientist at the University of Washington, who led the study said working part-time during the school year has been a fixture of American adolescence for more than 30 years and many of today’s teens not only hold part-time jobs, but work over 20 hours a week.

"Although working during high school is unlikely to turn law-abiding teenagers into felons or cause students to flunk out of school, the extent of the adverse effects we found is not trivial, and even a small decline in school engagement or increase in problem behavior may be of concern to many parents," adds Monahan.

The bottom line, suggests Monahan: "Parents, educators, and policymakers should monitor and constrain the number of hours adolescents work while they are enrolled in high school."

The study appears in the January/February issue of Child Development.

Meals around the family dinner table is something many health professionals have been trying to push these days, considering numerous studies in the past have linked the activity to children eating more nutritious foods and getting quality face-time with their parents and siblings.

But according to a University of Illinois scientist, eating meals together as a family could be even more beneficial for children suffering from chronic asthma, as long as those meals contain three ingredients in the right amounts.

"Family mealtimes, when they're done right, are linked to many benefits for children, including a reduced risk of substance abuse, eating disorders, and obesity. In this study, we've put these mealtimes under a microscope so we can see minute by minute which factors deliver these healthy outcomes," said Barbara H. Fiese, director of the U of I's Family Resiliency Center.

Which three ingredients make such a big difference? Fiese said it’s as easy to remember as ABC:

• Action, which includes eliminating such distractions as cell phones and the TV;
• Behavior control, which involves discipline that isn't harsh and also teaches manners; and
• Communication that shows genuine interest and concern about what's going on in each others' lives.

And, because any good recipe is specific about the amounts of each ingredient, Fiese has issued some guidelines.

"Communication is by far the most important ingredient. The average family meal takes 18 minutes, and I'd allot about 2 minutes to action, 4 minutes to behavior control, and 12 minutes to positive communication that affirms kids' importance, helps them resolve troublesome issues, and reminds them to take their medicine or write a thank-you note," she said.

Fiese and her colleagues videotaped 200 families that included children aged 5 to 12 with persistent asthma, observing and coding their actions during family meals.

Questionnaires 

Caregivers filled out a questionnaire assessing the severity of the child's symptoms, and a respiratory therapist checked the kids' lung functioning. The researchers controlled for adherence to medication.

The kids filled out a 23-item asthma-specific questionnaire assessing their quality of life, rating such items as the degree to which they worried about their symptoms and how well they were able to take part in everyday activities.

"When children were part of families that 'followed the recipe,' their asthma symptoms were less severe and they were more apt to take their medicine. They also tended to worry less about their symptoms, and they were able to engage more fully in activities at school and after school," said Fiese.

And when mealtimes had more distractions, Fiese said the children’s asthma symptoms were more pronounced.

"In families headed by a single parent or when the primary caregiver had less education, we found that mealtimes contained more disruptions, including watching TV and talking on cell phones, and less time talking about the day's events. If there's a lot of confusion, it's hard for family members to follow conversations," she said.

Single parents and those with less education also spent more time controlling behavior and were likely to use harsher methods to restore order to the family table.

However, being a single parent or having lower levels of education doesn’t necessarily cause more disruptions during mealtimes,  but rather the disruptions could stem from families having fewer resources, having more difficulty managing their time, and needing more assistance.

Thrive on routine 

According to Fiese, children thrive on routine, and disorganized meals are related to poorer health for the children who participate in them. These children are believed to be at highest risk for poorly controlled asthma and are most likely to use the emergency room for health care.

"We need to pay attention to the chronic stress that compromises health in low-income families that have few resources," she said.

Fiese notes recent research suggesting poor organization -- a lot of chaos in the family environment -- disrupts learning and predicts poor social and emotional development.

"Family mealtimes that follow these ABC guidelines are an important ritual that parents can use to counter that trend," she said.

The study was published in the January/February 2011 issue of Child Development.

Co-authors are Marcia A. Winter of the University of Rochester Medical Center and Joanna C. Botti of Upstate Medical Center in Syracuse, New York.

Former President Jimmy Carter has become a somewhat controversial figure in recent years, from his comment that George W. Bush's international relations were “the worst in history,” to his 2008 meeting with the leader of Hamas.

His book Palestine: Peace Not Apartheid, published in 2006, also sparked outrage, with critics charging that use of the word “apartheid” was insensitive and disrespectful, and taking issue with many of the book's statements, such as Carter's assertion that “Israel's continued control and colonization of Palestinian land have been the primary obstacles to a comprehensive peace agreement in the Middle East.”

Now a group of Carter's detractors have filed suit against the 39th President of the United States, alleging that the book was falsely marketed as “the absolute truth” on the subject of peace negotiations between Palestine and Israel.

The suit, filed in federal court in New York, also names Simon & Schuster, which published the book, as a defendant.

Suit: Book contains “demonstrable falsehoods”

The action says that Carter's book contains “demonstrable falsehoods, omissions, and knowing misrepresentations designed to promote Carter’s agenda of anti-Israel propaganda,” and that Simon & Schuster has refused to issue corrections despite “irrefutable proof” that the book contains falsehoods.

“You cannot market it as the absolute truth on something when it’s not,” David Schoen, the attorney who filed the suit, told The New York Times in an interview. “There is an ongoing debate about the Mideast, and to misstate, mislead and misconstrue those things intentionally is a very grave, bad act.”

Schoen says that criticism of the book by scholars like Dennis Ross, a longtime U.S. diplomat, and Kenneth Stein, who left the Carter center after calling the book “replete with factual errors,” shows that the suit is meritorious.

Schoen: Look at Frey suit

Schoen says that the successful lawsuit against James Frey -- whose book A Million Little Pieces was marketed as a memoir but was later revealed to contain a number of altered facts -- is proof that his suit will succeed. But the plaintiffs won that suit only because Frey and publisher Random House agreed to settle, not because a jury agreed with the plaintiffs' contentions. It is unclear whether Schoen will be able to obtain a similar result.

Adam Rothberg, a spokesman for Simon & Schuster, issued a statement calling the suit “frivolous [and] without merit.”

The suit “is a transparent attempt by the plaintiffs, despite their contentions, to punish the author, a Nobel Peace Prize winner and world-renowned statesman, and his publisher, for writing and publishing a book with which the plaintiffs simply disagree,” Rothstein said. “It is a chilling attack on free speech that we intend to defend vigorously.”

With Spring Break around the corner, the number one thing many teens and college kids do to prepare for their week at the beach is get a tan. Even the known health consequences of tanning seem to sway few from an activity long thought of as the most important part of getting "swimsuit ready."

Perhaps because of this, dermatologists are urging people -- especially young people -- to practice proper sun protection and understand the importance of early detection of skin cancer, the most common type of cancer.

Speaking today at the 69th Annual Meeting of the American Academy of Dermatology (Academy), dermatologist Brett M. Coldiron, MD, FAAD, clinical associate professor of dermatology at the University of Cincinnati in Cincinnati, Ohio, presented new statistics pointing to an increase in non-melanoma skin cancer and why young people are at an increased risk of developing this disease.

Coldiron reported in a recent analysis of Medicare claims, data showed treatment performed for non-melanoma skin cancers in the United States nearly doubled from 1994 to 2006.

Specifically, the total number of new non-melanoma skin cancers in 2006 was estimated to be more than 3.5 million.

“While the American Cancer Society estimates more than 2 million new skin cancers will be diagnosed this year, our research shows that the annual incidence in 2008 could actually have been 3.7 million,” said Coldiron.  “This is especially troubling as our estimate only includes Medicare patients, which means this could be even higher when young people are included in the count.”

Ultraviolet (UV) light exposure (both natural and artificial) has been proven to be the most preventable risk factor for skin cancer, however Coldiron said the long-established culture of tanning for the sake of vanity often includes annual spring break vacations to sunny climates that glamorize laying out in the sun.

Coldiron notes most dermatologists know how difficult it can be to change behavior, even in the face of proven scientific evidence.

“Attitudes about tanning are no different, as studies have shown that even though people know that overexposure to ultraviolet light can lead to skin cancer, they still tan. We need young people to realize that tanning for cosmetic reasons now will ultimately negatively affect their appearance later and even increase their risk for skin cancer.”

While both basal cell and squamous cell carcinomas can be easily treated if detected early, prevention is the smartest route -- and not just for partying Spring Breaker-ers.

To minimize the risk of skin cancer, the Academy recommends everyone "Be Sun Smart":

• Generously apply a broad-spectrum water-resistant sunscreen with a Sun Protection Factor (SPF) of at least 30 to all exposed skin. “Broad-spectrum” provides protection from both ultraviolet A (UVA) and ultraviolet B (UVB) rays. Re-apply every two hours, even on cloudy days, and after swimming or sweating.
• Wear protective clothing, such as a long-sleeved shirt, pants, a wide-brimmed hat and sunglasses, where possible.
• Seek shade when appropriate, remembering that the sun's rays are strongest between 10 a.m. and 4 p.m. If your shadow is shorter than you are, seek shade.
• Protect children from sun exposure by playing in the shade, wearing protective clothing, and applying sunscreen.
• Use extra caution near water, snow and sand as they reflect the damaging rays of the sun which can increase your chance of sunburn.
• Get vitamin D safely through a healthy diet that may include vitamin supplements. Don't seek the sun.
• Avoid tanning beds. Ultraviolet light from the sun and tanning beds can cause skin cancer and wrinkling. If you want to look like you've been in the sun, consider using a UV-free self-tanning product, but continue to use sunscreen with it.
• Check your birthday suit on your birthday. If you notice anything changing, growing, or bleeding on your skin, see a dermatologist. Skin cancer is very treatable when caught early.

For more information about skin cancer, please visit the SkinCancerNet section of SkinCarePhysicians.com, a website developed by dermatologists that provides patients with up-to-date information on the treatment and management of disorders of the skin, hair and nails.

An aggrieved New York City cab driver has filed a class action lawsuit detailing what he says are unsatisfactory -- and financially crippling -- working conditions.

According to the suit, because of the requirement that every cab carry an official medallion, the defendants “enjoy a monopoly on lawful cab service and, as such, taxicabs must bear a medallion issued by the City of New York in controlled numbers.” As a result, the suit says, the plaintiffs “must ... pay the lease fee to the possessor of a medallion from the City as a condition of practicing their trade.”

The suit, which targets Boulevard Taxi Leasing along with several other defendants, says that when Boulevard upgraded its fleet in 2008, it stopped allowing cabbies to lease cars on a weekly basis and instead required them to submit to daily leases. Under this new regime, the suit says, the defendant “required Plaintiff to lease the taxicab seven (7) days each week, without permitting Plaintiff to take a day off.” Although the plaintiff could choose to not work on a certain day, he still had to pay the lease fee to the company, according to the suit.

“Defendants also required [the plaintiffs] to lease the taxicabs on holidays, such as Thanksgiving and Christmas, despite the fact that Plaintiff and members of the class did not drive on those days,” the suit alleges.

Glimpse at life of cab drivers

According to the complaint, the defendant charged cabbies between $107 and $141 per day, amounting to “a weekly total of $894.” This amount is significantly higher than “the standard lease cap set by the TLC [Taxi & Limousine Commission]” of $666 per week, according to the suit.

The suit gives a rare glimpse into the cutthroat world of New York City cabbies.

The complaint says that “[t]he nature of the work that taxicab drivers perform exempt them from the protections of the Fair Labor Standards Act (“FLSA”) and other state wage and hour laws,” meaning that they “frequently work very long hours for pay that can be less than half of the minimum wage and are not provided with benefits.”

It's dangerous out there

The suit also points to Department of Labor statistics finding that “driving a taxicab is among the most dangerous jobs in the country,” with drivers “60 times more likely than any other U.S. workers to be killed on the job.” The suit also cites a report by the New York Committee on Occupational Safety and Health finding that “taxi drivers face a level of on-the-job assaults second only to those directed at police and private security guards.”

The suit seeks to certify a class of “all persons who leased taxicabs from Defendants at any time from January 20, 2005 to the entry of judgment in this case ... who were charged in excess of the TLC standard lease caps.”

Tough time for cabbies

The action comes at a generally tough time for cab drivers, who are nervously awaiting the fate of a proposal by Mayor Michael Bloomberg to legalize the practice of hailing livery cabs -- also known as gypsy cabs -- in the outer boroughs of the city. While livery cabs often pick up passengers who hail them, that practice is technically illegal; the cabs are supposed to be used only for pre-arranged pickups. But legalizing the already-common practice will, according to the executive director of the New York Taxi Worker's Alliance, “immediately cut into fares, especially during the rush hours when yellow cab drivers who live in the outer boroughs pick up fares at the beginning or end of their shifts."

Shaping Beauty, Inc. has been informed by the Food and Drug Administration (FDA) that a weight loss dietary supplement sold and marketed by the firm contains an undeclared drug ingredient.

FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement products are being recalled:

CELERITE™ SLIMMING CAPSULES

The products listed above were sold and distributed nationwide via the internet at www.shapingbeauty.com

FDA advises that these products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

No illnesses or injuries have been reported to the company to date in connection with this product. Shaping Beauty, Inc. has taken this action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Shaping Beauty, Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

Consumers are advised to return the product to the company’s address in Southampton, PA Consumers with questions may contact Shaping Beauty, Inc. Monday through Friday 9:00 am to 5:30 pm at 1-800-728-2850

Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website atwwww.fda.gov/Safety/MedWatch/default.htm2.

A Los Angeles Superior Court has granted a former Farmers Insurance customer, represented by Consumer Watchdog's attorneys, the right to challenge portions of a $455 million settlement of a national class action lawsuit against Farmers Group, Inc.

The case, known as Fogel v. Farmers Group, Inc., charges that Farmers required its policyholders to pay too much for a management fee that Farmers builds into its auto, home, and business insurance premiums. The company earns a 50% profit on the fee.

Last October, the plaintiff and defendants announced a settlement of the case, which includes $455 million to affected consumers and $90 million paid to the plaintiffs' attorneys, but the settlement details were not filed in court until two weeks ago.

Representing a former Farmers customer, Consumer Watchdog attorneys asked the court for permission to intervene in order to object to key provisions of the settlement. Over the objections of the insurance companies and the plaintiffs, Superior Court Judge William F. Highberger granted the Farmers customer's request to intervene in the case and postponed the preliminary settlement approval hearing until March 2, 2011.

Consumer Watchdog's legal papers raised the following objections to the settlement:

1. Consumers would be required to fill out a complex form in order to collect the estimated $20 refund; courts are increasingly skeptical of such settlements because very few customers end up submitting a claim.

2. Any unclaimed settlement funds would go to insurance entities that are controlled by Farmers and were originally defendants in this case.  The settlement provides no guarantee that the unclaimed funds will be used to benefit current policyholders, and giving the money to a Farmers affiliate clearly will not benefit policyholders who are no longer with the company.

3. The settlement bars a wide array of future legal claims by policyholders against Farmers, Zurich and the insurance affiliates for issues entirely unrelated to the management fee issue targeted by the lawsuit.  As a result, even if virtually none of the settlement is paid to actual policyholders, Farmers will be released from liability nationwide for a range of possibly illegal conduct that has nothing to do with the lawsuit.

"We are pleased that we will have the opportunity to pursue fair terms for class members, including actual refunds, before the court," said Consumer Watchdog lawyer and founder Harvey Rosenfield.  "Class action lawsuits are an important tool for justice when consumers get ripped off and fixing the terms of this settlement will benefit Farmers' policyholders nationwide."

Consumer Watchdog is a nonprofit, nonpartisan organization with offices in California and Washington, D.C.

The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females.  It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.

Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection  was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN.  Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well. 

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination.  For all of the indications for use approved by the FDA, Gardasil's full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.  

As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc, of Whitehouse Station, N.J. The most commonly reported adverse events include fainting, pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents.

Falls after fainting may sometimes cause serious injuries, such as head injuries. This can be prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.

A class action lawsuit charges that Nutella hazelnut spread is advertised as healthy for children even though it is loaded with saturated fat and processed sugar.

The plaintiff, Athena Hohenberg, is the mother of a four-year-old child. She said she bought Nutella after seeing advertisements that described it as a healthy and nutritious breakfast food, but was surprised to learn that Nutella was “the next best thing to a candy bar.”

"Nutella … contains 70% saturated fat and processed sugar by weight," the complaint charges. "Both of these ingredients significantly contribute to America's alarming increases in childhood obesity, which can lead to life-long health problems."

Nutella is made by Ferrero, an Italian company that developed the original recipe in 1949 when taxes on cocoa beans made traditional chocolate prohibitively expensive. Sold in over 75 countries, Nutella consists of 50 percent chocolate and 50 percent almond or hazelnut paste.

The product label lists the main ingredients as sugar and vegetable oil, mostly palm oil. The company says about 40 percent of the calories come from sugar.

The company's U.S. Subsidiary, Ferrero USA, is based in Somerset, N.J. It also makes Tic-Tac breath minuts and Ferrero Chocolates.

The complaint alleges that the plaintiff was "shocked" when she learned that Nutella was not healthy and "was the next best thing to a candy bar."

The lawsuit, filed in the U.S. District Court for the Southern District of California, alleges that Ferrero USA Inc. violates California consumer protection laws.

It also claims violations of California's laws pertaining to unfair competition and false advertising and alleges breach of warranty and seeks injunctive relief and compensatory and punitive damages. The purported class comprises all consumers who purchased Nutella beginning in January 2000.

Verizon Wireless says, not only did its first day of iPhone sales go smoothly, the company set a one day sales record Thursday.

At 8:10 p.m. EST Thursday, Verizon Wireless halted online orders of the iPhone 4 to existing customers after having what it called "the most successful first day sales in the history of the company." The company did not disclose how many iPhones had been ordered.

"This was an exciting day," said Dan Mead, president and chief executive officer for Verizon Wireless. "In just our first two hours, we had already sold more phones than any first day launch in our history. And, when you consider these initial orders were placed between the hours of 3 a.m. and 5 a.m., it is an incredible success story. It is gratifying to know that our customers responded so enthusiastically to this exclusive offer - designed to reward them for their loyalty."

Mead praised Verizon Wireless employees, who he said worked tirelessly to strengthen and scale the company's systems, enabling what proved to be unprecedented customer orders through the company website.

A good day

"Overall, it was a very good day," he said.

Verizon Wireless apparently took lessons from AT&T's well publicized activation problems when the iPhone debuted in 2007. Many consumers who stood in line to buy one of Apples new iPhones had difficulty in getting it to work.

"Your activation requires additional time to complete," many consumers reported being told.

Normally, a mobile phone is activated by personnel in the retail store where it is purchased. But with the anticipated sales volume for the new device, Apple and AT&T devised a plan whereby consumers would activate the phones themselves, connecting the phone to their computers and using Apples iTunes to complete the process. AT&T said the system worked as planned for the vast majority of consumers but conceded some customers experienced activation issues.

Two-step process

Verizon chose only to take orders yesterday, so there were no activation issues. Phones won't be activated until they begin arriving February 10.

Mead also said Verizon customers will have another opportunity at being among the nation's first to own an iPhone 4 on the Verizon Wireless network.

"Yesterday's launch set the pace for next week when we open up sales to everyone across America."   

The general market launch of the iPhone 4 on the Verizon Wireless network will occur on Feb. 10. The company said it will open its more than 2,000 Verizon Wireless Communications Stores at 7 a.m. The phone will also be available at all Apple store locations, Best Buy, select Wal-Mart stores, and online.

The U.S. Consumer Product Safety Commission (CPSC) is warning consumers that "SafetyCraft" brand full-size and portable drop-side cribs manufactured or distributed by Generation 2 Worldwide contain drop-side hardware that appears to be identical to Generation 2 Worldwide ChildESIGNS brand drop-side cribs recalled in February 2010.

This hardware found on SafetyCraft drop-side cribs can fail and place infants and toddlers at risk of strangulation and suffocation. CPSC staff urges parents and caregivers to stop using these cribs immediately and find an alternative, safe sleeping environment for their baby. Do not attempt to fix these cribs.

Ownership change

Generation 2 Worldwide ceased operations in 2005. The "SafetyCraft" trademark was then purchased by Foundations Children's Products of Medina, OH. SafetyCraft cribs manufactured and sold by Foundations Children's Products are NOT the subject of this safety alert. Consumers can identify the Foundations SafetyCraft crib with "Foundations" printed on the mattress support assembly instructions label under the crib mattress.

Because Generation 2 Worldwide ceased operations, CPSC has limited information about these cribs and where they were sold. CPSC has been unable to identify major retailers that sold these cribs.

Identifying products

The name "SafetyCraft" appears on a label affixed to the crib's headboard or footboard. Product labels may identify the place of manufacture as Indonesia or Dothan, Alabama.

This warning involves all SafetyCraft drop-side cribs, including model 92-8112, manufactured and/or sold by Generation 2Worldwide. Some of the cribs have a clear plastic headboard and footboard. These cribs are in use in child care facilities as well as homes.

Danger to children

The crib's plastic drop-side hardware can break, which can cause the drop side of the crib to detach from a corner of the crib. When the drop side detaches, it creates a space into which an infant or toddler can roll and become wedged or entrapped.

When a child is trapped between the drop side and the crib mattress, it creates a risk of suffocation or strangulation. In addition, the crib's mattress support can detach from the crib frame, creating a hazardous space in which an infant or toddler can become entrapped and suffocate or strangle.

CPSC received reports of three infant suffocation deaths and 20 drop side-related incidents involving previously recalled models of Generation 2 Worldwide and ChildESIGNS cribs with plastic hardware similar to "SafetyCraft" cribs.

Parent advice

CPSC reminds parents not to use any crib with missing, broken, or loose parts. Make sure to tighten hardware from time to time to keep the crib sturdy. When using a drop-side crib, parents should check to make sure the drop-side or any other moving part operates smoothly.

Always check all sides and corners of the crib for disengagement. Any disengagement can create a gap and entrap a child. In addition, do not try to repair any side of the crib, especially with tape, wire or rope.

Incident or injury reports that are either directly related to this product recall or involve a different hazard with the same product can be made here.