December 19, 2014

Unnecessary Chest X-Rays for Kids

X-rays should never be given unless there’s a good reason, but researchers at the Mayo Clinic have found that too many children are being given chest X-rays when there’s no benefit to them.

In a news release issued by the Radiological Society of North America, Dr. Ann Packard said, "Chest X-rays can be a valuable exam when ordered for the correct indications. However, there are several indications where pediatric chest X-rays offer no benefit and likely should not be performed to decrease radiation dose and cost." Packard is a radiologist at the Mayo Clinic.

The dangers of radiation are cumulative. That is, exposure to radiation builds up in the body, and problems might not present for decades. So being exposed to the radiation in an X-ray should be carefully considered, especially in young people because the effects of the experience stay with them forever.

Packard and Dr. Kristen B. Thomas, co-author of the study and head of the pediatric division at the Mayo Clinic, reviewed 719 pediatric chest X-ray exams given over a six-year period in inpatient, outpatient and emergency room settings. The patients ranged in age from newborn to 17 years old.

Of the 719 X-rays:

  • 377 exams were ordered for chest pain

  • 98 for syncope (fainting) or presyncope

  • 21 for a general feeling of being unwell or under distress (spells)

  • 37 for postural orthostatic hypotension (POTS), a condition in which blood pressure drops suddenly when the individual stands up from sitting or lying down

  • 185 for dizziness

  • 1 for cyclical vomiting

Eighty-two of the 719 exams were excluded because of congenital or other known heart disease, and other causes.

A key finding was that in nearly 9 in 10 of the nonexcluded patients, the exam did not alter clinical treatment. None of the patients who underwent X-rays for syncope, spells, POTS, dizziness or cyclical vomiting had any finding that affected treatment.

Only about 12 in 100 of the chest X-rays for chest pain were positive, and included respiratory symptoms such as cough, fever or trauma.

Clearly, too many kids are getting too many chest X-rays. "I would like this research to help guide clinicians and deter them from ordering unnecessary exams which offer no clinical benefit to the patient," Packard said in the statement.

If your practitioner wants to give your child a chest X-ray, ask why he or she believes this is the best, or only approach, especially if the patient has no respiratory symptoms. Ask the doctor what he or she expects to learn from the test.

For more information, see our safety tips for radiation exposure, and read our patient safety blog on new guidelines for imaging tests.

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April 25, 2014

Devices Approved for Pediatric Use Often Aren’t Tested on Children

An unsettling study recently published in the journal Pediatrics shows that most medical devices that the FDA has approved to treat children weren’t tested on them first.

Mostly, such devices were tested in clinical trials on patients at least 18 years old.

One of the study’s authors, Thomas J. Hwang, a research fellow at Harvard Medical School, told, "Children are not simply 'small adults,' and a device found to be safe and effective in adults may have a very different safety and effectiveness profile when used in a pediatric population."

"Without this data, it is difficult for clinicians and parents to make informed treatment decisions that weigh the risks and benefits of a particular treatment," he said.

The practice of ignoring how kids might respond differently to treatments given to adults is hardly new — last year we wrote about how pharmaceutical companies often don’t conduct clinical trials with children for drugs tested on and approved for adults.

The Pediatrics study reviewed testing that had been done on medical devices meant for kids since an act of Congress helped spur their development seven years ago. Researchers analyzed data from the main clinical trial used for the 25 medical devices approved by the FDA for use in patients 21 and younger between 2008 and 2011. Nearly half — 11 — weren’t tested on any patients younger than 21, and only four of the devices had been tested on patients younger than 18.

Three of the devices included in the study were approved specifically for people younger than 18, whom the FDA considers pediatric; the rest were approved for 18- to 21-year-olds.

Researchers said, however, that devices approved only for older adolescents probably are used "off-label" in younger children because, often, there are no alternatives.

Doctors may prescribe a treatment for something other than what it was approved for (“off-label), but it’s illegal for manufacturers to promote such use.

Most of the devices in the Pediatrics study had been approved with a stipulation that their manufacturers conduct post-market trials after they reached the commercial market. The idea was to ensure they were safe and effective. But only three required that youngsters be included in the trials, and none of those was complete.

"Designing devices for children is more complex because they are still growing and may need to have the device for many decades, in contrast to older adults," Dr. Katherine Bates, a cardiology fellow at The Children's Hospital of Philadelphia, told Reuters.

There are ethical and practical issues about using children with rare diseases in clinical trials, even though without them you can’t determine how a device will perform in the long term. And government incentives for conducting clinical trials with children are available for drug manufacturers, but not for device makers.

Some of the devices in the Pediatrics study were approved from observational study data, not the more rigorous results of randomized, controlled trials. The FDA requires at least one clinical trial demonstrating that a device is safe and effective before it approves it for general patient use. But these trials don't necessarily have to include the same type of patients who will get it once it’s marketed.

Just as women don’t necessarily respond to a drug or device as men will, or the elderly versus middle-aged people, children might not either.

Cardiologist Rita F. Redberg, editor of JAMA Internal Medicine, told Reuters “Common sense would dictate that devices would be studied in the appropriate populations before they are used on the market.”

As Reuters notes, approval requirements exempt “high-risk” devices, or those that support or sustain life for patients with rare diseases (fewer than 4,000 people in the U.S. each year); such devices must demonstrate only that they are safe and probably beneficial. But they can’t be sold for profit.

The 2007 act of Congress eliminated the nonprofit provision for devices intended for children, and established grants for nonprofit pediatric device developers.

Three of the 25 devices included in the Pediatrics study invoked the rare disease exemption.

If your pediatrician, or any other doctor, recommends a certain device to treat your child, ask if it has been tested on children, or how much evidence there is that it will be effective and safe. And consider enrolling your child in a trial in order to enlarge the small body of current knowledge about how devices work in children.

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September 20, 2013

Feds Try Harder to Make Manufacturers Test Drugs for Use by Children

Children are not miniature adults, and drugs intended to be consumed by adults aren’t necessarily good medicine for kids. A blog post on the FDA Voice website explains why.

Lynne Yao, associate director, Pediatric and Maternal Health Staff in the FDA’s Center for Drug Evaluation and Research, reminds readers that some drugs work differently according to where in the human maturation the person taking them is. Efficacy is one issue for children taking drugs intended for adults, and safety is another. “That’s why products that are used in children,” Yao says, “must be studied in children."

Two recently reauthorized laws promote that effort. The carrot is the Best Pharmaceuticals for Children Act (BPCA), which offers drug companies six months more of marketing exclusivity if they conduct FDA-requested pediatric studies. The stick is the Pediatric Research Equity Act (PREA), which requires some drugs developed for adults to be studied in children. The studies must be conducted with the same drug and for the same use for which they were approved in adults.

As Yao notes, before BPCA and PREA became law, more than 8 in 10 drugs approved for adult use were being used in children, even though their safety and effectiveness had not been established in children. Today, it’s about 5 in 10. And now that both acts have been reauthorized with additional FDA powers, the hope is that the disparity will shrink farther.

Under PREA, FDA may waive studies in children if they aren’t necessary, such as a drug prescribed for a disease only adults contract, like prostate cancer.

When Congress reauthorized PREA last year as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), it gave the FDA additional authority. The agency may grant extensions for deferred pediatric studies at a sponsor’s request if there is good cause; say, the manufacturer has tried but failed (so far) to recruit a sufficient number of pediatric patients to complete the study.

Sometimes the FDA allowed a deferral and still the deadline was missed, so now, if a sponsor fails to seek or obtain a deferral extension, fails to submit deferred pediatric studies by the final due date agreed to with FDA or fails to request approval for a required pediatric formulation, the FDA will send a noncompliance letter to the company and publish it on the web.

The first such “we warned you” noncompliance letters were published last month, along with the manufacturers’ responses. You can track this show-and-tell at the FDA’s public page here. Among the early letters and responses are those concerning an intravenous form of Protonix, a drug to reduce gastric acid made by Pfizer, and Renvela, taken by people with chronic kidney disease, made by Sanofi.

Other drugs on the tardy-testing list include allergy, anaphylaxis and blood pressure medications, all of which are prescribed for children.

As noted on, however, it’s unclear whether these laws and the transparency of noncompliance give the FDA enough muscle to compel compliance.

The letters state that the companies failed to satisfy their obligations to conduct pediatric studies on approved children’s medications, but as AboutLawsuits points out, the FDA may label a drug misbranded only if the studies are not conducted. It may not withdraw approval. It’s unclear if the agency can levy fines or take any other punitive actions beyond the public scolding.

Some of the drugs on the letter list were supposed to have been tested on children as long as seven years ago. In each case, AboutLawsuits says, the companies failed to apply for an extension. Although the letters give the companies 45 days to respond, they are silent about any consequences or what happens next.

The FDA’s renewed interest in the safety of pediatric drugs follows recent studies depicting how some medications used on adults have detrimental effects in children.

For example, a study published last month in JAMA Psychiatry found that children who use antipsychotic medications such as Risperdal and Zyprexa had three times the risk of developing type 2 diabetes during the first year of use. That study was the result of a government investigation into the increasing number of children who were prescribed antipsychotic medications intended for adults.

If your child is prescribed a medication, ask the doctor if it has been tested in that form and in that dose for children. If not, or if he or she doesn’t know, consult Medline Plus, the government’s drug information clearing house, and the manufacturer’s website.

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July 13, 2012

Trade Group Tantrum Undermines Play Yard Standards

In 1998, a 17-month-old boy confined in a folding Playskool Travel-Lite play yard at his day-care provider’s home died when the side rails collapsed around his neck. The play yard had been recalled, but the caregiver was unaware.

Last year, a 3-month-old girl was snoozing in a bassinet that was snapped onto the side of her play yard. Because the assembly was not proper, the bassinet somehow detached, tilted and pushed her face into the mesh side of the play yard. She suffocated.

We’ve written about injuries associated with cribs and playpens, and the tragedies noted above were remembered, according to a story in the Washington Post, when the Consumer Product Safety Commission’s (CPSC) mandated new safety standards for folding play yards last month. The problems that caused the first accident were addressed; the problems that caused the second were not.

The CPSC ensures the safety of approximately 15,000 consumer products. At least 19 deaths have been tied to the side rail defect that killed the little boy, and about 1.5 million portable cribs with the defect have been recalled. them. Deaths declined as the industry embraced stricter standards, but some of the pre-standard models remain unaccounted for, according to Kids in Danger, an organization founded by the parents of the little boy who died.

Since 1985, according to The Post, there have been 20 recalls of play yards—also known as pack-and-plays—representing numerous deaths. The play yard safety standards approved last month require that portable cribs be tested to ensure such serious hazards have been addressed, but in certain quarters, the bassinet accessory dangers aren’t considered serious enough.

“It’s disheartening that we couldn’t get this taken care of,” Nancy Cowles, executive director of Kids in Danger, told The Post.

Congress approved a bill in 2008 that added muscle to the CPSC. One element requires the agency to strengthen some voluntary standards. The play-yard standards were among them, and regulators had been working with the industry to effect the necessary product changes.

Shortly after the CPSC heard about the baby girl’s death, the relationship between the guards and the guarded deteriorated. The CPSC added language making it more difficult to assemble a play yard with missing parts, which contributed to the baby’s death last year. One proposal required manufacturers to stitch all the parts together so that none could go missing.

In May, the Juvenile Products Manufacturers Association (the industry’s trade group) requested that the provision take effect later than originally intended. The CPSC agreed. In June, however, half an hour before the commission held a briefing on the standards, it received a letter from the JPMA accusing the CPSC of violating the law because it hadn’t solicited public comment on that provision.

The commission now plans to deal with this issue separately, and in a statement after the decision, the JPMA said it is pleased with that outcome. It also promoted itself as a guardian of kid safety:

“Each year, JPMA sponsors Baby Safety Month in September to educate parents and caregivers on the importance of the safe use and selection of juvenile products. Baby Safety Month 2012 is dedicated to helping educate parents and caregivers on the importance of safely using second hand, hand-me-down, and heirloom baby gear.”

This expressed concern for child safety would have more credibility if those articulating it would do the right thing instead of standing on ceremony.

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November 14, 2011

Cholesterol Tests for Kids

Here's something about children that most of us don't know, which is connected to some facts that most of us do know.

Most people know that America is an increasingly obese nation. Most people know that obesity is a risk factor for heart disease, stroke, diabetes, osteoarthritis and lots of other threats to health and life. Most people know that obesity can raise blood cholesterol levels, and that adults often have cholesterol tests to determine if their levels are dangerous.

For the first time, medical experts are recommending that all children also have their cholesterol checked.

It’s not just a sound health-care practice, it’s a sad reflection that kids are getting fatter right along with the rest of us. And that the seeds of heart disease, diabetes and strokes are sown early in life.

Approximately one-third of U.S. children are overweight or obese. And although being overweight doesn’t always result in high cholesterol, it’s always a reason to check.

As described in the Los Angeles Times, although kid cholesterol tests have become an unfortunate necessity, the recommended procedure is not the same as the one for adults. Tests should be given at least once when kids are between 9 and 11, and again when they’re between 17 and 21. They’re not usually necessary every year.

And the kid cholesterol test doesn’t require fasting, as the adult test does. It involves either a blood draw or maybe just a finger prick in the doctor's office. If the first test suggests abnormal cholesterol levels, a fasting cholesterol test would be the next step.

The panel’s recommendations were published in the journal Pediatrics.

Even overweight children typically don't suffer heart attacks, but looking for precursors of heart disease is an effort to head that future event off at the pass. "Heart disease is the No. 1 cause of death in our society," said Dr. Stephen R. Daniels, the panel chairman. "We know the process that leads to those deaths begins in childhood. We also know that people who are able to maintain a low risk through childhood and early adulthood have a lower risk.”

The National Heart, Lung and Blood Institute – a branch of the National Institutes of Health (NIH) – developed the guidelines for testing cholesterol in kids, and they were endorsed by the American Academy of Pediatrics. Heart specialists and pediatricians called them long overdue.

The previous guidelines, dating to 1992, said children should be given cholesterol screenings only if their family history included heart disease or high cholesterol.

Experts predict that the most immediate impact of universal cholesterol screening for children will be imparting a sense of urgency among parents and primary caregivers to improve kids’ diets and exercise habits if the test discloses higher than normal cholesterol, whether or not they’re overweight. (Just as overweight people can have normal cholesterol, sometimes cholesterol can be elevated even if you aren’t carrying extra pounds.) They don’t anticipate widespread prescription of medication.

According to one study mentioned in The Times’ story, no one knows how many children have abnormal cholesterol, but more than 28% of children who are overweight may have metabolic syndrome. That’s a cluster of risk factors including high blood pressure and high cholesterol.

In addition to the cholesterol test, the new report suggests other ways to monitor and manage heart risk in children. They include:

  • exclusively breast-feeding babies for the first six months of life;

  • feeding children a diet low in saturated fat beginning at 1 year;

  • counseling children about diet and exercise if they score above the 85th percentile on weight-height charts (that threshold means the child’s weight is higher than 85% of other children at that height).

The guidelines suggest different diets depending on a child's weight and whether he or she has high blood pressure or high cholesterol.

We’ve written often about the misguided, expensive and potentially dangerous medical practice of over-testing. But this isn’t one of those situations. Although some cholesterol tests for kids might signal a need for changes in behavior, changes that might seem overly restrictive as if you can’t let a kid be a kid, parents must realize they’re only making an investment in the future.

And that sometimes doing what’s best for a child brings positive change for the whole family.

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November 2, 2011

Concussions and Kids and Consumers' Pocket Books

A hot topic in the world of sport safety these days is concussion. It’s not the first time we’ve covered the topic. Thanks to an increasing awareness that concussions can lead to traumatic brain injury (TBI), cognitive decline and other problems, athletes are monitored more closely for signs of head injury.

But greater awareness and better medicine have a concussion traveling companion of a decidedly consumer orientation. So-called “anti-concussion” sports equipment is making its market move. As always, it’s buyer beware.

As reported in the Los Angeles Times, no piece of equipment, no matter how technologically advanced, can indicate the presence of brain damage, or guarantee protection from it.

Testifying a couple of weeks ago at a U.S. Senate hearing, Jeffrey Kutcher, chairman of the American Academy of Neurology's sports section, said, "I wish there was such a product on the market. The simple truth is that no current helmet, mouth guard, headband or other piece of equipment can significantly prevent concussions from occurring."

Parents are a target market for these products, and football is a prime activity.

  • Item: a $149 chin strap made by Battle Sports Science called the Impact Indicator that features colored lights to "help" indicate whether a player has a concussion.

  • Item: the Brain-Pad LoPro mouth guard, which promises "brain safety space.

  • Item: Riddell's Revolution helmet, whose pitch is to reduce the number of concussions by 31%. Kutcher said research showed that the helmet decreased concussions by only 2.6%.

Good equipment is key, whether you’re a 12-year-old middle linebacker or a 47-year-old softball catcher. But the best way to prevent brain damage (or worse) after a head injury is to take the time necessary to recover. Children have relatively heavier heads than adults, and because their brains are still developing, the incidence and severity of their head injuries is higher.

According to the Centers for Disease Control and Prevention (CDC), the number of traumatic brain injuries among young athletes has increased 60% over the last 10 years. In 2001, 153,375 young athletes were admitted to emergency rooms for concussions and other sports-related head injuries. In 2009, that number had climbed to 248,418. Approximately 298 youths per 100,000 suffered a head injury in 2009. Males 10 to 19 had the highest rate of injuries.

Motorcycle and auto accidents account for about 20% of traumatic brain injuries. According to the CDC, the most common sports and games leading to TBI are:

  • bicycling

  • playground activities

  • football

  • basketball

  • soccer.

It’s difficult to resist the appeals of a kid who can’t wait to get back into the soccer game. But if she was dizzy, nauseous, had vision problems or a headache, even momentarily, she’s done until a doctor examines her. And certainly anyone who has gotten knocked out should be seen by a doctor immediately.

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October 9, 2011

MRIs and Children: What Is the Appropriate Use?

Medical ethicists have been grappling with the use of magnetic resonance imaging (MRI) for pediatric clinical trials. They have been trying to clarify how MRIs can meet the “minimal-risk standard” used by ethics committees to determine if a study is permitted to proceed.

The side effects of MRIs have been clear, but until the publication of a study in IRB: Ethics & Human Research, it wasn’t clear what factors contributed to the diagnostic tool’s problems overwhelming its utility.

The study concluded that the risks of physical and psychological harm to a child undergoing an MRI are no greater than the risks associated with a healthy child’s everyday activities. The problem comes in the form of the intravenous contrast dye or sedation sometimes used in conjunction with the MRI – they increase the odds of harm to an unacceptably high degree.

MRI is a popular diagnostic device because it affords exceptional views into the human body. The physical risks involve its strong magnetic force, and the psychological harm most often comes in the form of anxiety. The procedure can be claustrophic, noisy and time-consuming.

To parse the problems with MRIs, researchers examined the risks from MRI alone, and those attendant to using contrast-enhancing agents and sedation in conjunction with it. They found that:

  • The risk of physical injury from MRI was 17 in 100,000 examinations, and the risk of death was 4 in 100 million examinations.

  • The risk of injury in children younger than 16 was 4 in 100,000 hours of playing soccer, and 12,730 in 100,000 hours of playing ice hockey.

  • The risk of death from riding in a motor vehicle for children younger than 14 was 6 in 100 million car trips, and for teens from 15 to 19, 40 in 100 million.

Assuming that an MRI examination lasts an hour, the risk of injury associated with an MRI falls within the lower end of this range, the authors write.

Psychological harm in children between 10 and 18 included:

  • being disturbed by the confined space, about 1 in 10;

  • being bothered by the noise, about 15 in 100;

  • being unable to complete the MRI scan because of claustrophobia, 1 in 100.

The rates were lower on average than those of children who report fears associated with anxiety disorders; in one study of children between 8 and 13, nearly half reported fears associated with subclinical anxiety and 1 in 5 met the full criteria of an anxiety disorder.

When an MRI examination calls for the injection of a contrast dye, the risk is allergic reaction, such as fever, headache and anaphylaxis (airway constriction, heart abnormalities). The risk of minor reactions from MRI contrast dyes was about 5 in 100, which is comparable to the risk of minor reactions from routine vaccinations. The risk of anaphylaxis was 7.5 in 100,000 doses; that’s higher than the risk of anaphylaxis from vaccinations. “MRI with contrast enhancement therefore does not meet the minimal-risk standard,” concluded the researchers.

They also concluded that the risk from sedation in MRIs, which includes gastrointestinal complaints and motor imbalance, does not meet the minimal-risk standard, based on the risks posed by sedating medications such as over-the-counter cold medicines.

MRI is a valuable diagnostic tool. But in refining its application, we're starting to see, again, how a child is not an adult.

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October 3, 2011

Choosing Safe Toys

Toys might be playthings, but protecting your kids from their dangerous effects is serious business. The 2-year-old Consumer Product Safety Improvement Act helped protect little ones from exposure to lead and phthalates in toys, but now there’s another concern: cadmium.

As described by WebMD, it’s also a toxic metal used by manufacturers instead of its predecessors. Regulators and health and safety advocates are lobbying to lop cadmium from the list of toy ingredients, but the question remains: What’s next?

It’s impossible to create a “clean room” for kids, nor would you want to raise a child so divorced from real life. But that doesn’t mean there aren’t ways to reduce exposure to substances that can impair health and to minimize the negative effects some toys have on the environment.

Healthy Stuff is a consumer guide/database that identifies safe toys. It also offers information about testing if any has been conducted. The Consumer Product Safety Commission posts recalls online, as does If a toy you own is recalled, follow the company’s instructions on how to get a safe replacement.

Otherwise, here are a few tips to promote fun and reduce the chances of a toy causing more trouble than it’s worth. For everybody.

  • Choose natural over synthetic. Opt for toys made of solid woods with no finish or a nontoxic finish, and organic cotton, wool, felt, and other textiles.
  • Recycle household items. Kids are happy when their imaginations are encouraged to run free. An empty box, a set of stainless steel bowls, empty rolls of paper towels can become a fort, an orchestra, an arsenal of gentle weapons.
  • Avoid cheap jewelry and kids’ cosmetics. These products generally carry a higher health risk. Kid jewelry often contains high lead or cadmium levels and kid cosmetics often are laden with questionable chemicals.
  • Purge plastics. It’s difficult – OK, impossible – but strive to buy less plastic. And when you do, look for those labeled Nos. 1, 2, 4, or 5 within the triangular, recycle arrow icon usually found on the bottom of the product. If there’s no label, call the manufacturer.
  • Buy less. Buy fewer toys. It’s better for the planet and saves you money.
  • Spend more for what you do buy. High-quality toys last much longer and can be enjoyed by successive users.
  • Read labels. What’s the toy made of? Where was it made? Google the manufacturer and/or the toy’s name to find out what other users say.
  • Buy local. The shorter the distance a toy travels from manufacturer to user, the less the greenhouse gas emissions. If you’re buying foreign products, remember that Europe, Canada and Japan have more stringent toy regulations.

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August 28, 2011

A Simple Heart Test for Newborns

One in 100 newborns has a malformed heart. It's the most common birth defect. Now, a federal advisory panel recommends a simple and painless test for all newborns to detect such defects before the babies are released from the hospital.

Pulse oximetry measures the amount of oxygen in the blood via a small light sensor taped to a baby's wrist, hand or foot. It's inexpensive ($5-$10), fast (five minutes) and can detect a life-threatening condition otherwise difficult to find in a physical exam. An infant's cardiovascular system might appear normal in the first few days after birth, even though it continues to mature.

According to WebMD, only two states -- Maryland and New Jersey -- legally mandate the test. Some hospitals elsewhere do it voluntarily, but it's not in widespread use.

The federal panel's advice has been endorsed by the American College of Cardiology, the American Heart Association and the American Academy of Pediatrics.

If you're expecting, and you don't live in Maryland or New Jersey, make sure your hospital knows you want the test to be performed before your bring junior home. The chances of heart problems are low, but it's better know if there is one -- and to address it -- before it presents far from where it can be treated.

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July 10, 2011

Test for Newborns Is Questionable Medicine and Bad Policy

One health-care analyst takes issue with the groundswell of states considering a mandatory test for newborns that looks for signs of congenital heart disease. Writing on Medpagetoday, Gary Schwitzer says, "The tests aren't always accurate ... and some doctors say they will prompt follow-up tests that could prove expensive -- perhaps as much as $1,500."

He quotes physicians concerned not only about cost, but who question that the tests will even have a positive effect on outcomes. "Politicians love screening tests," Schwitzer writes, "[w]hether evidence supports the tests or not."

For example, he says that at least 28 states have enacted laws requiring insurers to include coverage for prostate-specific antigen (PSA) testing, never mind that the U.S. Preventive Services Task Force (USPSTF) disagrees. He also cites the new federal health-care reform legislation, which ignores the U.S. Preventive Services Task Force recommendations on mammography.

"In the apparent attempt to look like do-gooders, politicians may inadvertently cause harm by legislating screening mandates that don't reflect all of the available evidence."

The trouble with both prostate testing and mammograms is that they produce a lot of false alarms that lead to further testing and sometimes harmful treatment, with no eventual upside in lives saved or lives prolonged.

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March 1, 2011

Republicans aim to cut financing for toy hazard database

In 2008, Congress passed the Consumer Product Safety Improvement Act after a flood of unsafe toys from China hit the U.S. market. Less than three years later, however, the new Republican-led House of Representatives wants to roll back those protections by cutting $3 million in financing for a database where consumers could report product hazards and the public could check products before buying them.

It also wants to scale back back the requirement for third-party testing for lead and other hazards in products sold to children, while some GOP representatives have even proposed limiting the new protections to products for children under 6 or 7, rather than up to 12 years of age.

As part of this latest campaign against government regulation, some businesses warn that (a) the hazard database would open the door to bogus charges and lawsuits; (b) third-party testing of children’s products is too costly; and (c) some products should not be tested at all for things like lead because children are unlikely to eat them.

The New York Times, which is highly critical of the new campaign, calls the concern over frivolous lawsuits “a predictable canard,” noting that the database was designed with safeguards to avoid bogus claims. In an editorial, the paper noted that the small increase in costs due to testing is more than offset by the damage incurred by families and society when a child is poisoned or hurt by a dangerous toy, and that exposing older children to similar risks is unacceptable.

It also points out that there is still a lot of lead out there. Since the new law was passed in 2008, the Consumer Product Safety Commission has issued 26 lead-related toy recalls.

Source: The New York Times

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February 21, 2011

Almost 10,000 crib and playpen injuries a year, study says, but will Congress roll back safeguards?

Nearly 10,000 infants and toddlers are hurt in crib and playpen accidents each year, according to a recent study.

The release of the study coincides with a U.S. House subcommittee hearing on February 24 on consumer product safety issues during which the subject of cribs is expected to come up. The American Academy of Pediatrics opposes loosening crib regulations and is concerned that the industry may seek to roll back parts of a 2008 law which called for mandatory crib standards, including more rigorous safety testing, noting that this peer-reviewed study indicates why such a rollback would be a step backward.

The study, which was released in the journal Pediatrics, examined 19 years of Emergency Department data and is the first nationwide analysis of ER treatment for crib and playpen injuries. Researchers found a gradual decrease in the injury rate between 1990 and 2008; they also found that recent safety measures including a ban on drop-side cribs appear to be having a positive impact.

Still, better prevention efforts are needed since, even in the most recent years examined, an “unacceptable” average of 26 infants daily were injured in crib-related accidents, says study lead author Dr. Gary Smith, director of the Center for Injury Research and Policy at Nationwide Children's Hospital in Columbus, Ohio.

Most injuries were from falls in toddlers between ages 1 and 2. According to the study, 181,654 infants were injured between 1990 and 2008, though most children were not hospitalized. The data also reveal 2,140 deaths, not including crib-related deaths in children who didn't receive treatment in the ER.

The 2008 law called for mandatory crib standards, including more rigorous safety testing. The federal Consumer Product Safety Commission mandate, which takes effect in June 2011, bans the manufacture and sale of traditional drop-side cribs with side rails that move up and down to make it easier to place and remove infants. The movable rails can become partially detached, creating a gap between the mattress and rail where babies can get stuck. Dozens of injuries and deaths including suffocations have been linked with drop-side cribs, and millions of such cribs have already been recalled.

Source: Washington Post

You can view a copy of the study abstract here.

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December 23, 2010

Feds finally ban drop-side cribs

The federal government has finally banned the traditional drop-side crib. In a unanimous vote, the Consumer Product Safety Commission (CPSC) voted to ban the manufacture, sale and resale of the cribs.

Drop-side cribs, so-called because they have a side rail so that the side of the crib can move up and down, making it easier for parents to lift their babies out of the crib, are believed to have caused the deaths of more than 30 children over the past decade. During the same period, millions were recalled over safety concerns.

Effective June 1, a new standard takes effect that requires cribs to have fixed sides. Hotels and childcare centers have 2 years to purchase new cribs. The new rules also mandate more stringent safety tests that mimic how children of different ages behave in cribs. Older children typically apply more force to the crib by shaking, running around and jumping in it. The new tests will ensure cribs can take the additional pressure. In addition, better labeling on crib pieces will also be required.

CPSC Chairman Inez Tenenbaum called the new rules some of the strongest in the world and predicted they will significantly cut crib-related accidents.

Anticipating the ban, crib makers have been phasing out drop-side cribs for the past few years. Last year, ASTM International, the organization that sets voluntary industry standards, approved a drop-side ban.

However, many parents still have drop-sides in their homes. They also can be found in secondhand stores.

Source: Associated Press

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December 17, 2010

CPSC "recalls" its recall of lead-laced drinking glasses

The Consumer Product Safety Commission has reversed an earlier decision and now says lead-laced drinking glasses with images of superheroes and characters from the Wizard of Oz are intended for adults, not children.

Previously, the CPSC had said the glasses were children’s products and therefore had to meet strict federal lead limits. Independent lab testing by the Associated Press had determined that the amount of lead in the colored decorations was as much as 1,000 times the federal maximum for children's products. There are, however, no limits on lead content for adult drinking glasses.

The main danger of lead ingestion is to the developing brains of small children.

According to agency spokesman Scott Wolfson, “a premature statement was made regarding two sets of glasses . . . that has now been determined to be inaccurate." Ironically, it was Wolfson himself who had announced that the glasses were children’s products and that CPSC would launch an investigation into their lead content. After Wolfson’s initial statement, the company that imported the glasses from China announced it was pulling them from the market and would recall those already sold.

Wolfson now says that CPSC staff weren’t in possession of the glasses when they were declared children’s products. “After thoughtful analysis by child behavior experts at CPSC, it has been determined that the glasses are not children's products [because] the size, weight, packaging and price of the glasses sampled by CPSC are consistent with glasses more commonly used for consumption of adult beverages."

Jim Therrell, a professor at Central Michigan University who wrote the guidelines used by CPSC to determine what items children of different ages use, disagrees. “"Kids would choose this glass over a plain glass. If you consider that they are all movie based, they're all fantasy based, the fantasies would probably range in appeal to ages 4 to 5 at the low end up through 11, 12."

Under federal law, an item is a "children's product" if it is "primarily intended" for those 12 and under.

Source: Bloomberg BusinessWeek

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December 4, 2010

Feds probe lead-tainted drinking glasses for kids

The U.S. Consumer Product Safety Commision (CPSC) has launched an investigation into lead levels in themed drinking glasses depicting comic book and movie characters. CPSC ruled that the glasses were children’s products, and therefore subject to stricter standards than those intended for adults.

The CPSC said it was collecting samples of all glasses cited in a continuing Associated Press probe into dangerous metals – cadmium,in particular – in children's merchandise.

After CPSC announced that it considers the glasses children's products, Warner Bros. said it would stop selling them, and the importer, Utah-based Vandor LLC, said it would pull them from the broader market, despite its insistence that the products were marketed to adults, not children. The Chinese-made glasses depict the likes of Superman, Wonder Woman and characters from "The Wizard of Oz" such as Dorothy and the Tin Man.

About 160,000 glasses have been recalled since AP disclosed that laboratory tests it commissioned showed that colored designs in a range of glasses contain high levels of lead or were made in such a way that lead or cadmium could escape and contaminate the hands of someone handling them.

The CPSC said its own inquiry would extend beyond the superhero and Oz glasses to include others cited by AP "that have decorations that children would be attracted to."

Child safety advocates worry that that toxic metals rubbing onto children's hands can get into their mouths and cause cumulative damage over time. Testing performed so far revealed that the enamel used to color the glasses contained 1,000 times the the amount of lead (i.e. the enamel was 30% lead, whereas the federal limit is 0.03%).

Had the regulators decided the glasses weren’t children’s products, they wouldn’t be subject to the strict federal limits.

Both Vandor and Warner Brothers, which sold the glasses, insisted that the principal cutomers were adult collectors and that they made the decision to pull the glasses in "an abundance of caution." But on Warner Brothers own website, the glasses were sold alongside a lunch box and children’s T-shirts with superhero images.

Source: Boston Globe

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November 23, 2010

186,000 visits to ER due to defective toys, CPSC says

Kids under 15 made 186,000 visits to the ER due to defective toys, according to figures released by the Consumer Product Safety Commission (CPSC). But there’s also good news in the latest CPSC report: deaths resulting from use of toys are down, as are toy recalls. But toy related injuries, particularly lacerations and contusions, are up.

CPSC says the number of toy recalls dropped to 44 in fiscal year 2010, down from 50 in 2009 and 172 in 2008. It credits its new toy safeguards -- establishing the lowest lead content and lead paint limits in the world; converting the voluntary toy standard into a mandatory standard; and working with Customs and Border Protection data systems to better track shipments of dangerous products from other countries -- as helping to restore confidence in the safety of toys sold in the U.S.

Toy-related fatalities also decreased; in 2009. CPSC received reports of 12 deaths to children under the age of 15, down from 24 toy-related fatalities both in 2007 and 2008. Riding toys were associated with almost 60 percent of the reported deaths in 2009: three with tricycles, two with powered riding toys and two with nonmotorized riding toys or unspecified riding toys.

On the negative side, 2009 saw a massive recall of Mattel Inc.’s Fisher-Price toys, with more than 10 million products targeted, including infant toys, high chairs and toy cars. These products were recalled for many different reasons, including choking hazards and protruding parts.

Source: Bloomberg Business Week

You can read the complete CPSC report here.

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November 18, 2010

Big recall of Roman shades, roll-up blinds and roller blinds because of strangling hazard in small kids

In conjunction with the U.S. Consumer Product Safety Commission (CPSC), Hanover Direct Inc. (also known as Domestications, The Company Store and Company Kids) has recalled nearly 500,000 Roman shades, roll-up blinds and roller blinds because of strangulation hazards to small children.

In October 2009, about 90,000 Roman shades were recalled due to strangulation fears. Strangulations can occur when a child places his/her neck between the exposed inner cord and the fabric on the backside of the blind or when a child pulls the cord out and wraps it around his/her neck.

The latest recall of about 495,000 items came after a 22-month old boy was found hanging from his neck from the outer cords of a Roman shade in May. The outer pull cords were knotted at the bottom. The child was rescued by his father but later died in a hospital.

To date, no injuries or incidents attributable to rollup or roller blinds have been reported. However, strangulations can occur with roll-up blinds if the lifting loops slide off the side of the blind and a child's neck becomes entangled on the free-standing loop or if a child places his/her neck between the lifting loop and the roll-up blind material. With roller blinds, strangulations can occur if the blind's continuous loop bead chain or continuous loop pull cord is not attached to the wall or the floor with the tension device provided and a child's neck becomes entangled in the free-standing loop.

The new recall involves all styles of Roman shades with inner cords, all styles of roll-up blinds, and roller blinds that do not have a tension device. A tension device is intended to be attached to the continuous loop bead chain or continuous loop pull cord and installed into the wall or floor.

The blinds were sold at Hanover Direct/Domestications, the Company Store/Company Kids; online at and; and through catalog sales nationwide from January 1996 through October 2009 for between $20 and $579. They were manufactured in China, the United States, and other countries.

Consumers should immediately stop using all Roman shades with inner cords, all roll-up blinds, and all roller blinds that do not have a tension device, and contact the Window Covering Safety Council at (800) 506-4636 anytime for free repair kits or visit

Consumers who have roller blinds with a tension device should make sure the tension device is attached to the continuous loop bead chain or continuous loop pull cord and is installed into the wall or floor.


You can view the original CPSC recall report here.

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November 3, 2010

Three drop-side cribs are recalled as CPSC joins child safety groups in crib education campaign video for new parents

The U.S. Consumer Product Safety Commission (CPSC) recently joined three child safety organizations to release "Safe Sleep for Babies," a new crib safety video aimed at helping all new parents avoid suffocation, strangulation and entrapment risks. CPSC also announced three new recalls of dangerous drop-side cribs.

Collaborating with CPSC on the video, which is moderated by TV journalist Joan Lunden, were the American Academy of Pediatrics (AAP), Keeping Babies Safe (KBS) and New York-Presbyterian/Morgan Stanley Children's Hospital.

Meanwhile, CPSC recently recalled nearly 40,000 drop-side cribs due to concerns about “entrapment, suffocation and fall hazards.” More than 34,000 of these were for Heritage Collection 3-in-1 drop-side cribs, which were manufactured in Vietnam and retailed at K-Mart nationwide from February 2007 through October 2008 for about $130.

The remaining recalls were for drop side cribs (a) manufactured in China and sold online at, Babyage and other Web Retailers from December 2004 through January 2009 under the “Longwood Forest” or “Angel Line” label for about $140; and (b) manufactured in the United States and China and sold at Ethan Allen stores from January 2002 through December 2008 for between $550 and $900.

The "Safe Sleep for Babies" video, which aims to educate new and expectant parents and caregivers on crib safety while they are at the hospital or visiting their pediatrician's office, is part of CPSC's Safe Sleep Initiative, a multi-pronged effort aimed at reducing crib deaths and injuries. In addition to this education effort, CPSC's Safe Sleep Initiative includes the development of new crib standards, warnings about drop-side cribs, sleep positioners, and infant slings, and the recall of millions of cribs in the past five years.

CPSC will distribute the video online and through its network of about 100 hospitals nationwide. NewYork-Presbyterian/Morgan Stanley Children's Hospital plans to make the video available to all families as part of their parent education programs, and provide copies to hospitals in the NewYork-Presbyterian Hospital Healthcare System. The American Academy of Pediatrics will promote the video to its 60,000 members and will feature it on AAP's parents-focused website,, where it will be available for download.

Source: Consumer Product Safety Commission
For more information on the crib recalls, go here.
You can view the video here.

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October 8, 2010

Regulators, science kit makers clash over possible ‘toxic’ paper clips

Science kits – and some of the items they contain, including paper clips used to show children how magnets work -- could require more stringent safety testing if the Consumer Product Safety Commission determines that the kits are “children’s products.” Science kit makers, meanwhile, argue that the items in the kits aren’t harmful to children and are everyday items found in homes and schools that don’t need to be tested when they are purchased separately.

The manufacturers asked for a testing exemption, but the CPSC would not grant a blanket waiver. In a 3-2 vote, CPSC approved a “guidance” that is supposed to help determine which products require testing under legislation passed by Congress two years ago that requires safety checks for items such as lead, chemicals and flammable materials.

After the vote, CPSC chairman Inez Tenenbaum said that “there is nothing in this rule that bans science kits.” The manufacturers, however, have threatened to cease supplying kits to elementary school children because of the testing requirement.

The approved document does not explicitly demand testing of the kits or their components. It does, however, indicate that how the kits are packaged and marketed (for example, whether they are intended for children 12 or under) could determine whether testing is required.

The science kit manufacturers say that a CPSC guidance subjects their products to a double standard – i.e. paper clips bought at an office supply store would not need to be tested, while those in the science kit would be. "They miraculously become a children's product when our clients pick those products up and put them in a science kit," a manufacturers’ representative said.

Two CPSC commissioners criticized the guidance. Anne Northup said the guidance should have carved out products that pose little or no risk. “We are not making reasonable decisions,” she said. Another commissioner, Nancy Nord, wrote on her blog that “it is crazy that the Hands-On Science Partnership needs to be concerned about doing lead tests on products purchased at an office supply store and then packaged into a science teaching kit for use with children. Even crazier is the fact that if a teacher buys the same paper clip at the same store and uses it for the same science teaching project, it's okay."

Consumer advocates, however, maintain the tests must be performed “to ensure that products for children are safe.”

Source: Associated Press

You can view the CPSC decision here on page 35.

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September 29, 2010

Researcher jailed over faked child safety tests for lighters

You might think that “childproof” means just that; unfortunately, in the case of cigarette lighters, it may not mean much at all. A Florida researcher who conducted child safety tests on thousands of brands of cigarette lighters has been sentenced to eight months in prison plus eight months of home detention after admitting that she falsified test data and results for more than 11 years.

Karen Forcade, president of Youth Research Inc. (now-defunct), altered birth dates, sex and schools of study participants between March 1994 and August 2005 to meet Consumer Product Safety Commission (CPSC) guidelines.

She made these changes to her own data and to information collected by other companies she had hired to perform the tests. In one 1998 test she falsified data for 96 of 100 children tested. In another, she took the data for children who tested one set of lighters, changed their birthdates by as much as 5 years, and submitted the same data for a test of a different lighter.

Forcade’s long-running scheme began to unravel after CPSC scientist spotted anomalies in test results, including similar handwriting on all parents’ consent form signatures, misspellings of testers’ names, and similar handwriting from purportedly different testers on data collection forms.

Forcade pleaded guilty to one count of conspiracy to commit fraud in January. In addition to the jail time and home detention, her sentence includes a $10,000 fine and three years of supervised release.

Source: St. Petersburg Times

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