Posted On: September 27, 2013

How Big Pharma and the Feds Caused Infant Deaths Over Confusing Acetaminophen Dosages

For 15 years, McNeil Consumer Healthcare, a division of Johnson & Johnson, had sold two versions of Tylenol for young children even though the company knew that parents and doctors were confusing the two. They knew that confusion could have serious, even deadly, results. The FDA ignored the problem.

We’ve addressed the problem with dosing with acetaminophen, the active ingredient in Tylenol, and now a shocking story by the investigative news site ProPublica.org probes even deeper into the confusion over the two types of pediatric Tylenol, and why that’s so dangerous. Remarkably, the story says, “Drop for drop, the strength of Infants’ Tylenol far exceeded that of Children’s Tylenol.

“In addition, the active ingredient in Tylenol, acetaminophen, has what the FDA deems a narrow margin of safety. The drug is generally safe at recommended doses, but the difference between the dose that helps and the dose that can cause serious harm is one of the smallest for any over-the-counter drug.”

Other manufacturers’ products compounded the problem by also offering two children’s products with different concentrations of acetaminophen. Between 2000 and 2009, 20 reports of children who died from acetaminophen toxicity were filed with the FDA, which acknowledged that the figure probably “significantly underestimates” the true incidence.

Between 2001 and 2010, according to the American Association of Poison Control Centers, about twice as many deaths each year were associated with acetaminophen than with all other over-the-counter pain relievers combined, according to data from. Tens of thousands more are hospitalized for overdoses.

ProPublica tells the heartbreaking stories of babies who suffered unnecessarily. To see how the intersection of federal regulatory sloth and pharmaceutical company misbehavior conspired to harm and sometimes kill people seeking only to relieve pain, see our blog, “Acetaminophen Continues to Rack Up Casualties and Escape Regulatory Control.”

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Posted On: 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 AboutLawsuits.com, 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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Posted On: September 13, 2013

Schools Are Better at Teaching Healthful Habits

Last month, the Centers for Disease Control and Prevention (CDC) released the results of a study about how well schools follow healthful policies and practices. And the news is good!

“Schools play a critical role in the health and well-being of our youth,” CDC Director Tom Frieden said in a news release about the School Health Policies and Practices Study (SHPPS). “[M]ore students have access to healthy food, better physical fitness activities through initiatives such as ‘Let’s Move,’ and campuses that are completely tobacco free.”

SHPPS is the largest, most comprehensive assessment of school health policies and practices in the U.S. It’s conducted at the state, district, school and classroom levels nationwide to assess these eight components at the elementary, middle, and high school levels:


  • health education

  • physical education and activity

  • health services

  • mental health and social services

  • nutrition services

  • healthy and safe school environment

  • faculty and staff health promotion

  • family and community involvement.


Some specific results of the study show that after years of efforts to phase out junk food, the ratio of school districts that prohibited it in vending machines increased from about 3 in 10 in 2006 to more than 4 in 10 last year. And slightly more than half of school districts — up from about 35 in 100 in 2000 — made information available to families on the nutrition and caloric content of foods available to students.

Between 2006 and 2012, the ratio of districts with food procurement contracts that addressed nutritional standards for foods that can be purchased separately from the school breakfast or lunch increased from 55 in 100 to more than 73 in 100.

In terms of physical education, since 2000, the ratio of school districts that require elementary schools to teach physical education increased from more than 8 in 10 to more than 9 in 10 in 2012. And 6 in 10 school districts partner with a public or private entity such as parks, recreation departments, the YMCA, Boys or Girls Clubs, or the Boy of Girl Scouts for shared use of school or community property.

The ratio of districts with policies that prohibited all tobacco use during any school-related activity increased from about 47 in 100 in 2000 to almost 68 in 100 in 2012.

SHPPS was conducted at all levels in 1994, 2000 and 2006. The 2012 study collected data only at the state and district levels. The school- and classroom-level data from SHPPS will be collected in 2014 and released in 2015.

For more information about SHPPS, link here.

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Posted On: September 6, 2013

Study Showing Association Between Induced Labor and Higher Autism Risk for Boys Is Sloppy Science

A study published last month in JAMA Pediatrics indicated that boys whose mothers needed help to initiate or move the process of labor along may have a higher risk of autism.

But there are several reasons why the research contributes less to the body of knowledge and more to the mass of misinformation.

As reported by Bloomberg.com, induced labor, which stimulates the uterus in order to prompt contractions, and augmented labor, which increases the strength, duration and frequency of contractions, showed a 35 percent greater risk of autism in boys than babies whose mothers didn’t need those procedures.

According to the Centers for Disease Control and Prevention, 1 in 50 U.S. children between 6 and 17 years old is diagnosed with an autism spectrum disorder (ASD). Few childrens’ psychological disorders have been given more attention recently than autism, leading to a breathtaking wealth of misinformation about its causes, from vaccinations to diet.

The study was published in JAMA Pediatrics, a prestigious publication that, suggests writer Emily Willingham, should know better than to publish such incomplete research as the induced labor-autism risk study … or at least fully explain its considerable shortcomings.

In her analysis of the study on Forbes.com, Willingham points out that the study “did not show a cause and effect between induced (initiated) or augmented (hastened) labor and autism. It found an increased odds that a child born following a labor induction and augmentation would later be labeled as autistic by special education services. Yet there are problems with reaching even that conclusion.”

Instead of the cause-and-effect conclusion the researchers drew, Willingham said, they could just as easily have said, “Labor induction risk may be raised when child is autistic.”

Willingham noted several possibly influential factors that weren’t included in the study, probably, she surmised, because they weren’t available: mother’s BMI [body mass index, a measure of fitness that identifies percentages of fat and muscle] from pre-pregnancy; father’s age; child head circumference; specific child birth weight; mother’s insurance status; presence of any sibling births in the cohort; and whether or not the child had autistic siblings. “Lack of availability of relevant data,” Willingham states, “can sometimes make a study untenable, at least, and at best should warrant considerable caution in interpretation and speculation.”

Willingham goes into interesting detail about the study’s take on chances of an autism diagnosis and whether or not the mother has a college degree, or smokes, demonstrating, again, that science isn’t simple. We’d go a step further: Social pressure can’t overcome our desire to make it so.

To be clear, the researchers didn’t conclude that standard clinical practices be changed as a result of their study. “The results,” the lead author told Reuters, “don’t dictate there be any change in any clinical practices surrounding birth. The dangers to the mothers and the infants by not inducing or augmenting far outweigh the elevated risk for development of autism.”

In some circumstances, of course, induced labor can help reduce deaths among mothers and babies. But more studies are required to understand more fully why such procedures might be associated with the risk of disorders as elusive as autism.

Willingham’s conclusion reinforces what we hope readers will always consider when reading about research studies, even in the original form:

“This study didn’t show that induction or augmentation during childbirth substantially increases the risk for autism, although it hints at a greater influence of socioeconomic status and by implication, healthcare access. If anything, based on earlier literature, it adds a slight if only mathematical confirmation of the perception that births involving autistic children can be associated with more complications, such as the presence of meconium [fetal defecation], gestational diabetes and fetal distress, than births involving nonautistic children. And that points to induction and augmentation as useful in these situations, not as problematic, and certainly does not affirm them as a risk.”

For more information, see our blogs, “Autism Rates Rise,” and “Helping Parents Through the Autism Maze.”

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