Will Football Be Safer in the Future?


Researchers, former players discuss solutions at Aspen Institute event

Young athletes should visit sports medicine specialists when injured, new research shows playing football could cause chronic traumatic encephalopathy (CTE), and the age that kids should be permitted to play tackle football remains up for debate.

That’s according to physicians who spoke at the Aspen Institute’s Future of Football summit here Thursday. Two panels featured Robert Cantu, MD, a neurosurgeon with Boston University’s CTE Center and the Concussion Legacy Foundation, and Andrew Peterson, MD, a sports medicine specialist at the University of Iowa. Other panelists included former NFL players Dominique Foxworth and Chris Borland, and physicians in the audience also addressed issues.

While panelists were charged with debating whether youth football will largely shift from a tackle to flag format in the future and any implications, the issue of brain injury including CTE came to the fore. Many researchers believe CTE is caused by the repeated minor blows to the head that occur on every football play.

“We want all contact sports to be safer,” said Cantu, who helped devise sports concussion consensus statements published last year. But since roughly 2008, “every experience we’ve had with the BU group has only fueled [concern about football].” He had previously criticized one of the consensus statements last year for his colleagues’ refusal to link contact sports and CTE, and for omitting CTE animal and case studies from their review.

At the Aspen Institute event, Cantu cited a Boston University-led study published last week, in which examination of brains from eight young athletes and animal models indicated CTE can occur solely from “subconcussive” blows.

It’s possible to make football and other contact sports safer by improving coaching techniques and education to chiefly “remove the head from the game,” Cantu said Thursday. But, he added, “I want very much for football to be played in a safer form. I think that safer form is flag.”

Cantu worries about the consequences of football in its current form going the way of boxing — a once-popular sport that now draws mostly from lower socioeconomic classes. Many educated and wealthier people are banning their children from playing football to avoid brain injury. If this trend continues, far more kids from low-income, less-educated families would proportionally suffer brain trauma “and set them up for cognitive impairment” leading to anxiety, depression and more serious health problems.

During his presentation, Cantu listed more than a dozen NFL standouts who never played organized football before high school. “There’s not a single academic study that proves” playing before the age of 14 correlates with career success, said Cantu, who pushed USA Football — the umbrella organization that sets national youth guidelines — to call for leagues to ban tackle football for kids under 14.

USA Football is examining whether to set such a standard, said director Scott Hallenbeck. But the organization is awaiting research — unlike USA Hockey and US Soccer, which recently banned checking and heading, respectively, for younger players, although there’s little hard evidence that such bans would reduce head injuries.

“We’re going to have to follow the science, period,” Hallenbeck said. He noted USA Football has already changed other rules and guidelines “at every level,” although he acknowledged it is not acting as fast as some would like.

In one exchange, Hallenbeck wondered why many critics point to the NFL as a source of football’s safety problem. Cantu replied, “They’ve got billions and they’re funding research and they are funding USA Football.” Experts have critiqued these arrangements, and a 2016 MedPage Today analysis found the league was involved in a CDC youth sports safety program whose internal evaluations and success were questioned by independent researchers.

Crystal Dixon, whose son died after being paralyzed in a youth football game, called the preseason physical exams players must undergo “a joke.” Parents should take their kids to physicians independent of their teams, she suggested, noting many practitioners who administer the group physicals “don’t know if these kids’ bodies are ready.” Her son faced a higher risk of paralysis when he began playing, for example, which was not revealed until after he was injured.

 Too many physicians are not aware of the updated concussion guidelines and many cannot recognize possible symptoms, said Rebecca Rodriguez, DO, a family medicine specialist with San Diego Sports Medicine. They often then allow kids to return to play before they have healed, sometimes leading to more and worse brain injuries.

Kids should see sports medicine specialists after they suffer a suspected concussion, Rodriguez told MedPage Today. She recommended educating parents about the difference between these specialists and other pediatricians and family medicine doctors. Rodriguez also recommended standardized training for all practitioners caring for youth athletes, including pediatrics, family medicine physicians and ER doctors. “Because they’re going to come across [brain injuries],” she said.

Speaking during a second panel, Peterson noted that longitudinal studies are needed to draw conclusions regarding the subconcussive blows and CTE. But “it is a real issue,” he added, calling the animal model studies and studies of former NFL players “good data.” In addition to the Boston University work, he told MedPage Today that William Meehan, MD, of Boston Children’s Hospital, has been presenting an unpublished animal-model CTE study at conferences. Both “could be really useful for informing this,” said Peterson, who led a study published last yearindicating that flag football isn’t completely benign.

Gerard Gioia, PhD, a pediatric neuropsychologist with Children’s National Health System, said researchers are struggling with extrapolating findings from NFL professionals to youth players. Gioia rejected the under-14 ban, calling it “too black-or-white.” Instead he called for devising tests to determine when individual kids are developmentally prepared to play tackle football.

While the researchers debated, the two former NFL players both said they oppose youth tackle football. Foxworth, former president of the NFL Players Association, said he will not allow his son to play. Borland said that if the point of youth sports is to develop mind and body, “I don’t know why youth tackle still exists.”

Borland also questioned a 2015 American Academy of Pediatrics position statement on tackling in youth football, which argued against a ban in part because the authors concluded coaches can teach safer techniques. Said Borland: “There’s no way to do it entirely safely.”

More parents believe vaccines are ‘unnecessary,’ while a mumps outbreak grows


The contrast between parents’ attitudes about vaccines today and a decade ago is striking. A survey published Monday by the American Academy of Pediatrics shows that more and more moms and dads are refusing the shots for their children.

Much of the blame for this phenomenon can be attributed to continuing claims from everyone from actor Jim Carrey to Republican presidential nominee Donald Trump about the link between vaccines and autism — an idea that originated with a paper later shown to be fraudulent and that numerous scientific teams have tested exhaustively and found to be untrue. But while many parents’ scrutiny of vaccines may have been triggered by the autism theories, they have grown beyond those initial concerns.

That’s a big change, but the more interesting part of the survey is why.

In 2006, the No. 1 reason parents were refusing vaccines was because of concerns about the ingredient thimerosal causing autism. In 2006, 74 said it was about autism. In 2013, that number had declined to 64 percent.

Now, more parents are refusing the vaccine on the grounds that they are “unnecessary” — 73.1 percent in 2013 vs. 63.4 percent in 2006. Moreover, even parents who believe in vaccines appear to be delaying the shots that are supposed to be given on a strict schedule to maximize their effectiveness. Seventy-five percent of pediatricians said that parents asked for delays because of worries about their child’s “discomfort” and 72.5 percent because of a concern “for immune system burden.”

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That’s stunning because of the scary history of infectious disease in this country. Polio once killed and paralyzed by the hundreds. An outbreak in New York City in 1916 left an estimated 27,000 people infected and 6,000 dead. The disease is now making a comeback in parts of Afghanistan and Pakistan because of poor immunization rates. In a 1964-65 rubella outbreak that is being compared to what’s going on today with Zika, 1,000 babies miscarried or were aborted, and 20,000 others were born with defects because of rubella. A rubella vaccine is now one of the standard vaccines given in childhood.

The rapid speed at which a modern outbreak can spread was underscored in 2014-2015 when a single unvaccinated child with measles at Disneyland in California started an outbreak that spread to 146 people, many of whom were also unvaccinated. There were no deaths, but many became so seriously ill that they had to be hospitalized.

A lot of the recent controversy over vaccines has focused on a new vaccine for HPV, or human papillomavirus, for preteens or teenagers. The adoption of this vaccine has been low, in part because parents and pediatricians may be reluctant to discuss the fact that it protects against a sexually transmitted virus. Health officials have been focusing on the vaccine’s effectiveness for preventing cancer instead.

Health officials said that some of those infected had been vaccinated, leading them to wonder whether there is a new strain going around, but that they still believe immunization provides the best precaution and urged everyone in the area who has not gotten the measles, mumps and rubella (MMR) vaccine to get it right away. “We’re trying to prevent this from getting larger,” Lawrence Eisenstein, Nassau County’s health commissioner, told ABC News.

The AAP expressed alarm about the findings of the study, stating that “parental noncompliance” with the recommended schedule of the Centers for Disease Control and Prevention “is an increasing public health concern.”

If the AAP’s urging and the description of some of these outbreaks isn’t enough to persuade you to get yourself or your kids vaccinated, there’s also this.

The pediatrician survey also showed that more doctors are pushing back at parents who refuse vaccines for their children. In 2006, only 6.1 percent said they “always” dismiss patients for this. In 2014, 11.7 percent said they always dismiss patients. So if you continue to refuse vaccines, it’s your right — but it may be harder to find a pediatrician willing to support that choice than before.

Teething tablets may be linked to 10 children’s deaths, FDA says.


Ten deaths of children who used homeopathic teething tablets and 400 adverse events associated with the tablets have been reported to the US Food and Drug Administration, the agency said Wednesday.

The FDA warned caregivers to stop using the products, which parents use to soothe teething babies, and to take their child to a doctor immediately if the child experiences problems.
The agency is investigating the adverse events and the cases involving the deaths, as “the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review,” according to a statement.
The American Academy of Pediatrics Safe to Sleep Campaign suggests that <a href="http://www.cnn.com/2015/12/01/health/crib-bumper-deaths-rise/">no soft bedding -- including bumpers -- be used in cribs</a>. <br />They pose a risk of suffocation, strangulation or entrapment. Mattresses should be very firm, and no toys or pillows should be used. Cribs with drop rails also should not be used. The American Academy of Pediatrics offers more guidance on how to choose a safe crib.<br />
The deaths and adverse events — including fever, lethargy, vomiting, sleepiness, tremors, shortness of breath, irritability and agitation — occurred over the past six years.
In an emailed statement, Hyland’s, a maker of homeopathic teething tablets and gel, said, “Hyland’s has not been made aware of any data that supports the claims in the warning against our teething tablets and gels. Our understanding is that the Food and Drug Administration’s investigation of these products is still ongoing. The fact is that we have not been made aware of any medical or statistical evidence to support a causal link between homeopathic teething tablets and adverse outcomes at this point. We continue to request any available information and statistics from the FDA.”
Hyland’s said this week that it will stop distributing the products in the United States.
The company said in a letter posted on its website Tuesday that it chose to discontinue US distribution of its teething products.
“This decision was made in light of the recent warning issued by the Food & Drug Administration against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines,” the letter from Hyland’s employees said. “Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA.”
Hyland's Baby Teething Tablets

There is no recall on the products, including Hyland’s Baby Teething Tablets, Hyland’s Baby Teething Tablets Nighttime and Hyland’s Baby Teething Gel. CVS, one of the drugstore chains that sold Hyland’s, Baby Orajel Naturals and its own version of the teething products, pulled all of them from the shelves after the FDA warning. Walgreens also confirmed that it has withdrawn homeopathic teething products that were subject to this FDA warning.
“We are confident that any available Hyland’s teething products, including those you already have, are safe for use,” the Hyland’s letter said. “Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully and follow all instructions.
“We look forward to the future of homeopathic medicines as we work in partnership with the FDA,” the letter said.
FDA warns parents against using teething tablets and gels

The FDA issued a safety alert about the tablets in 2010, and Hyland’s issued a recall at that time. After lab testing, the FDA said it found inconsistent amounts of belladonna in the tablets. The agency also had reports of adverse events related to using the products that were consistent with belladonna toxicity. The FDA also was concerned because the bottles didn’t have child-resistant caps.
Since 2010, Hyland’s said, it reformulated the product to reduce the amount of belladonna and revamped its production process. “We also improved our system to monitor, investigate and trend all safety reports on any of our products. We have not seen any trend to indicate that Hyland’s teething medicines pose any risk to consumers,” it said on its website.
The American Academy of Pediatrics’ HealthyChildren.org has warned parents to stay away from teething tablets that contain belladonna and gels with benzocaine, citing the FDA warnings and the potential side effects.
Instead of teething tablets or gels, the American Academy of Pediatrics suggests that parents massage the child’s gums with a clean finger when a baby is in pain; use a solid teething ring or clean, wet washcloth that’s been chilled in the freezer; frozen bananas, berries or bagels. Parents can also give a weight-appropriate dose of acetaminophen, but should ask the child’s doctor about an appropriate dose.

Stop Giving Codeine to Children, AAP Says


The American Academy of Pediatrics (AAP) is now advising against giving codeine to children.

Although codeine is widely used for pain relief, genetic variability in a patient’s drug metabolism causes varied efficacy results, according to a new clinical report from the AAP called “Codeine: Time to Say ‘No.’” Patients’ response to codeine depends on how quickly their body metabolizes the opioid, and patients who are fast metabolizers may exhibit strong reactions.

Children, especially those with sleep-disordered breathing, are at particular risk for opioid sensitivity. Because of this, standard doses of codeine can be fatal in these children. In fact, case reports have consistently linked the use of codeine to life-threatening or fatal respiratory depression in kids.

Despite these well-documented risks, as well as concerns expressed by health care groups that include the AAP, the FDA, and the World Health Organization, codeine is still available without a prescription in OTC cough formulas from outpatient pharmacies in 28 states and the District of Columbia, and it is still frequently prescribed to children as an analgesic and antitussive agent. One study cited in the AAP report revealed that more than 800,000 patients younger than 11 years were prescribed codeine between 2007 and 2011.

A review of data in the FDA’s Adverse Event Reporting System from 1965 to 2015 revealed 64 pediatric cases of codeine-related severe respiratory depression and 24 codeine-related deaths, 21 of which involved children younger than 12 years.

The AAP report uncovered 3 common factors among the codeine-related life-threatening and fatal events that occurred:

1.     The majority of children were relatively young.
2.     The children were put on a postoperative pain regimen of scheduled acetaminophen and codeine.
3.     The children had undergone adenotonsillectomy for sleep-disordered breathing.

According to the AAP, the most effective way to reduce codeine-related adverse effects is to explore alternative medicines for pain relief. The clinical report mentions drugs such as oxycodone, tramadol, and tapentadol as potential avenues for treatment for pediatric patients. Nevertheless, determining a definitive alternative medication that is both safe and effective is difficult and requires further research.

As lead researcher Joseph D. Tobias, MD, FAAP, stated in a press release, “Effective pain management for children remains challenging because children’s bodies process drugs differently than adults do.”

Researchers have shifted their focus to the use of postoperative nonopioid analgesics, such as acetaminophen, and nonsteroidal anti-inflammatory drugs, such as ibuprofen, for acute pain relief in pediatric patients.

In 2015, the FDA recommended that the use of codeine-containing cough medicines should be contraindicated in children younger than 18 years. Final action on this recommendation is pending, and in the meantime, these medicines are still available at outpatient pharmacies for purchase.

According to the AAP, more restrictions on codeine prescribing in the pediatric population is necessary to reduce related risks. Further research on pain relief alternatives, coupled with provider and parental education on nonopioid treatments and the adverse effects of codeine, is key to establishing a safe treatment plan for children.

Hospital Readmission Not a Good Quality Measure for Children.


Preventable readmission rates for children are lower than all-cause readmission rates, according to a new study.

“The concern that many of us have is that there is much less to be gained from a major effort to reduce pediatric readmissions because so many are due to an unpredictable disease process,” James Gay, MD, from Monroe Carell Jr. Children’s Hospital at Vanderbilt University in Nashville, Tennessee, told Medscape Medical News.

“Pediatricians try very hard to keep their patients out of the hospital in the first place,” he explained, “so a large investment of time, energy, and funds to reduce pediatric admissions may not be very beneficial overall, and it might actually distract from efforts in other areas, such as concentrating on patient safety.”

Dr. Gay presented the results here at the American Academy of Pediatrics 2013 National Conference and Exhibition.

Pressure is on at hospitals to reduce 30-day readmissions, which are considered by some regulators to be a metric of patient safety and quality care. The Affordable Care Act requires a hospital readmission reduction program for facilities that treat Medicare patients and imposes penalties for institutions with high rates.

 

A large investment of time, energy, and funds to reduce pediatric admissions may not be very beneficial overall.

 

Hospital administrators are therefore keen to identify preventable readmissions. Some state Medicaid programs use the 3M Potentially Preventable Readmissions grouping software; however, data on its use in pediatric readmissions are lacking, said Dr. Gay.

His team assessed 1,749,747 hospitalizations in 58 Children’s Hospital Association member hospitals. They used the 3M software to calculate all-cause readmission rates with the company’s proprietary list of 314 All Patient Refined Diagnostic Related Groups.

The software flagged 80% or more of all-cause readmissions as potentially preventable for sickle cell crisis, bronchiolitis, ventricular shunt procedures, asthma, and appendectomy. In contrast, the software suggested that more than 40% of 30-day readmissions were not preventable, including those for seizures, gastroenteritis, central line infections, urinary tract infections, and failure to thrive.

For the 20 leading patient diagnostic groups for all-cause readmissions, the software algorithm removed chemotherapy, acute leukemia, and cystic fibrosis from the list of potentially preventable reasons.

Table. All-Cause vs Preventable Pediatric Readmissions

Day

All-Cause Readmissions (%)

Preventable Readmissions (%)

7

4.9

2.5

15

8.5

4.1

30

13.0

6.2

 

“There are many fewer pediatric than adult hospitalizations in the first place, and the numbers and rates of readmissions are lower in children,” Dr. Gay pointed out. According to Medicare estimates, “older adults have readmission rates of about 20% at 30 days. The overall pediatric rates are closer to 6% to 10%,” he added.

Conditions that drive hospital readmission in children, or lead to admission in the first place, are very different from those in adults, Dr. Gay said. For example, adults are more likely to be readmitted within 30 days because of a high prevalence of chronic conditions, like congestive heart failure and chronic obstructive pulmonary disease, whereas children have more acute illnesses, such as pneumonia, bronchiolitis, and asthma.

“Because of these issues, many hospital pediatricians believe that readmission rates are not a good quality measure for pediatrics,” Dr. Gay said.

Asked by Medscape Medical News to comment on this study, Mark Shen, MD, from Dell Children’s Medical Center in Austin, Texas, noted that “in this study, the single most common reason for readmission was chemotherapy. We expect these kids to come back — we’ve wiped out their immune system.”

Other children are discharged with the expectation they will return as well, he added. “Sometimes we know they’re coming back. We’re just giving them a break at home, such as children with sickle cell disease or ventricular shunts.”

This study is useful because it indicates that the rate of 30-day hospital readmission is lower for children than for adults. Further research could focus on key chronic conditions associated with more readmissions in children, which so far only have been identified in adults. “But we’re getting closer in pediatrics,” Dr. Shen added.

The study authors caution that the 3M software might not completely reflect the reasons for pediatric readmissions, and future studies are warranted to validate its use in this population. The broader issue is whether efforts to track and reduce adult hospital readmissions apply equally to pediatric patients, Dr. Gay said.

Helmets Still Uncommon Among Children in Bicycle Accidents.


Only 1 in 10 children involved in a bicycle accident was wearing a helmet, a review of emergency department records in Los Angeles County shows.

“We found decreased use among older children, minority groups, and those of lower socioeconomic status,” said Veronica Sullins, MD, from Harbor-UCLA Medical Center in Torrance, California.

Bicycle-related injuries are responsible for more than 250,000 visits to the emergency department and nearly 200 deaths a year. California has the second highest number of cyclist fatalities.

The use of a bicycle helmet reduces head injuries by 63% to 88%, but a small number of children younger than 15 years wear helmets, Dr. Sullins reported.

She presented the research here at the American Academy of Pediatrics 2013 National Conference and Exhibition.

Dr. Sullins and her team reviewed information from the Trauma and Emergency Medicine Information System for patients younger than 18 years. The median age of the children was 13 years, and 64% were male.

The primary end points were the association between helmet use and age, sex, insurance status, and race or ethnicity.

Only 11% Wore Helmets

Of the 1248 children identified, 11% were wearing helmets when their injuries occurred. Of these, 13.8% were younger than 12 years and 9.8% were 12 years or older.

Helmet use was 47% more likely in the younger age group (P < .03), was 10 times more likely in white children than in children from a minority group (P < .0001), and was twice as likely in children covered by private insurance as in those covered by public or no insurance (P < .0001).

There were no differences in any of the primary end points between the helmeted and unhelmeted groups. However, “we should note that of the 9 total deaths, 8 children were not wearing helmets,” Dr. Sullins said.

On multivariable logistic regression analysis, helmet use did not increase the need for emergency surgery, mortality, or length of hospital stay, after adjustment for age, race and ethnicity, and injury severity score.

Only injury severity score increased the risk for all outcomes. For every 1-point increase in injury severity score, length of stay increased by 0.4 days (P < .0001). Private insurance decreased the length of stay.

“Overall, less than 1% of patients died, few required emergency surgery (5.9%), permanent disability was very low (0.5%), but temporary disability was high (65.4%),” she said.

On the basis of the findings, Dr. Sullins and her team recommend that middle schools, high schools, low-income communities, and minority populations in Los Angeles County be targeted for bicycle safety programs.

Targeted Education

“This study picked up some remarkable trends in the difference in helmet use across different socioeconomic groups,” said Tanzid Shams, MD, who leads the concussion and brain injury program at the Floating Hospital for Children at Tufts Medical Center in Boston. “We need to look more closely at why this disparity exists.”

He told Medscape Medical News that “we want all children to wear helmets. One effective strategy would be to develop targeted campaigns that positively reinforce healthy habits.”

“The governing bodies for sports such as skateboarding and BMX can really get behind a campaign that encourages wearing helmets anytime one is riding a bicycle. I believe that a consistent message from role models can be highly effective,” said Dr. Shams.

He noted that in addition to emphasizing the value of helmets to parents, pediatricians should stress the importance of a proper fit.

“Very frequently, I see a child wearing a helmet that is loosely dangling off the head. When purchasing a bicycle helmet, one-size-fits-all may not be the best approach. The key is to go for a snug fit that does not constrict circulation or vision,” he explained.

“Several helmet manufacturers offer adjustable inner harnesses that allow for fit adjustments as the head of the child grows,” Dr. Shams said. “This feature is a good investment in terms of protecting the child from potential head trauma.”

Women’s intentions to breastfeed: a population-based cohort study.


Objective

Given that intention to breastfeed is a strong predictor of breastfeeding initiation and duration, the objectives of this study were to estimate the population-based prevalence and the factors associated with the intention to breastfeed.

Design

Retrospective population-based cohort study.

Setting

All hospitals in Ontario, Canada (1 April 2009–31 March 2010).

Population

Women who gave birth to live, term, singletons/twins.

Methods

Patient, healthcare provider, and hospital factors that may be associated with intention to breastfeed were analysed using univariable and multivariable regression.

Main outcome measures

Population-based prevalence of intention to breastfeed and its associated factors.

Results

The study included 92 364 women, of whom 78 806 (85.3%) intended to breastfeed. The odds of intending to breastfeed were higher amongst older women with no health problems and women who were cared for exclusively by midwives (adjusted OR 3.64, 95% CI 3.13–4.23). Being pregnant with twins (adjusted OR 0.73, 95% CI 0.57–0.94), not attending antenatal classes (adjusted OR 0.58, 95% CI 0.54–0.62), having previous term or preterm births (adjusted OR 0.79, 95% CI 0.78–0.81, and adjusted OR 0.87, 95% CI 0.82–0.93, respectively), and delivering in a level–1 hospital (adjusted OR 0.85, 95% CI 0.77–0.93) were associated with a lower intention to breastfeed.

Conclusions

In this population-based study ~85% of women intended to breastfeed their babies. Key factors that are associated with the intention to breastfeed were identified, which can now be targeted for intervention programmes aimed at increasing the prevalence of breastfeeding and improving overall child and maternal health.

Source:BJOG

Seizure Disorders Enter Medical Marijuana Debate.


The role of cannabinoids in the treatment of seizure disorders in children has come under the spotlight in recent months amid a string of media reports of parents obtaining the substances in states where medical marijuana is now legal and claiming “miraculous” reductions in seizures with the treatment.

Among the reports was that of a 6-year-old boy with Dravet’s syndrome, a rare form of childhood epilepsy, reported by CNN. In an interview, the parents said the boy was left immobilized by the 22 antiseizure pills a day required to control his seizures, but after treatment with a liquid, nonpsychoactive form of marijuana, he was able to make it through an entire day without a seizure for the first time since he was 4 months old, and continued to see substantial reduction.

“Instead of medical marijuana, this is miracle marijuana,” the father told CNN.

Another child with Dravet’s syndrome in Colorado, who was having 300 grand mal seizures a week and had lost the ability to walk, talk, and eat, was similarly reported to have her seizures drastically reduced to just 3 times per month after treatment with the liquidized form of cannabis, CNN reported.

In both cases, the treatment was low in tetrahydrocannabinol, or THC, the compound associated with the psychoactive properties of marijuana, and high in cannabidiol, which is not psychoactive and is instead believed to be medicinal. Both cases were also featured in a CNN documentary on medical marijuana, “Weed,” that aired Sunday, August 11.

With the increasingly abundant anecdotal but very high profile reports, neurologists can likely expect a surge in interest from parents, particularly those frustrated by intractable epilepsy in their children, who are logically asking “why not?”

“When patients, children or otherwise, are faced with bad situations and no good treatment they, or their parents, look ‘out of the box’ to find one,” said David M. Labiner, MD, a neurologist with the University of Arizona and director of the Arizona Comprehensive Epilepsy Program, in Tucson.

“Medical marijuana is one of those things being utilized now,” he told Medscape Medical News.

He added, however, that despite the anecdotal reports, the bigger picture in terms of clinical evidence of efficacy, or, importantly, long-term safety on such treatments is lackluster at best. “There is limited high-quality evidence about the efficacy and virtually no data about the safety of using marijuana or cannabinoids,” he said.

Medical marijuana is currently legal in 18 states and the District of Columbia, and in some states the approval explicitly includes treatment for epilepsy.

But a 2012 Cochrane review of all published randomized controlled trials involving the treatment of marijuana or one of marijuana’s constituents in people with epilepsy concluded that “no reliable conclusions can be drawn at present regarding the efficacy of cannabinoids as a treatment for epilepsy.”

With a primary outcome investigated for the trials of seizure freedom for 1 year or more or 3 times the longest interseizure interval, the researchers found 4 reports with a total of 48 patients randomly assigned to placebo or to 200 to 300 mg of cannabidiol per day.

Although none of the patients in the treatment groups were reported to have sustained adverse effects, none of the trials included reliable details of randomization and all were deemed to be of “low quality.”

In a commentary on the review, Jonathan W. Miller, MD, PhD, noted that in addition to the inconclusive evidence of efficacy, other evidence has suggested marijuana and low-dose THC can represent a possible seizure precipitant.

“Marijuana itself has major shortcomings as an epilepsy treatment,” writes Dr. Miller, who is director of Functional and Restorative Neurosurgery and director of Epilepsy Surgery at University Hospitals, Case Medical Center/Case Western Reserve University in Cleveland, Ohio. “Its psychotropic action can only be regarded as an adverse effect.”

“It is a biological product containing multiple compounds with unclear, possible, anti- or pro-convulsant effects, delivered in varying amounts from dose to dose,” he adds. “Long-term safety has not been adequately investigated.”

With the need for new epilepsy treatments pressing, however, he underscores the importance of evaluating the potential benefits of cannabinoids with more reliable clinical trials.

“Cannabidiol or other individual cannabinoids with minimal adverse effects could be extracted and given in precise doses in rigorously designed, blinded, randomized clinical trials to test efficacy and safety,” Dr. Miller urges. “This is a reasonable route for development of new antiepileptic drugs.”

Safe Dispensing a Concern

In the case of the California boy described in the CNN story, the parents said they obtained the cannabis from the Harborside Health Clinic, a medical marijuana dispensary in Oakland, California, that has billed itself as the “world’s largest pot shop” and sells concentrations with names such as “Deadhead OG” and “Afghani Hash.”

The clinic does claim to screen all of its products for safety and tests for potency as well as the presence of pathogenic molds, but Dr. Labiner, in agreement with Dr. Miller, asserted that if cannabinoids are shown to be effective anticonvulsants, they should be provided to the public with the same safety assurances as any other epilepsy drug.

“Rather than thinking about how to keep sick people from using these compounds, as many of our elected officials and law enforcement are doing, we need to support efforts to determine how to appropriately use these compounds in a controlled fashion and not delegate that responsibility to [places like] ‘the world’s largest pot shop’.”

Even the American Academy of Pediatrics (AAP) favors the pursuit of a better understanding of the potential benefits of medical marijuana, but, with the same concerns of operating in an unregulated environment in mind, the academy opposes laws legalizing medical marijuana.

“The AAP strongly supports more cannabinoid research to better understand both how these substances can be used therapeutically as well as their potential side effects — which we may well be underestimating,” said Sharon Levy, MD, MPH, director of the Adolescent Substance Abuse Program at Children’s Hospital Boston and an assistant professor of pediatrics at Harvard Medical School in Massachusetts.

“[But] the AAP does not support ‘medical marijuana’ laws as they circumvent regulations put in place to protect patients, and children are a particularly vulnerable population,” Dr. Levy told Medscape Medical News.

While noting that the reports on children finding seizure control from cannabinoids are “quite compelling,” Dr. Levy emphasized that medical marijuana as a policy misleads the public on the level of research behind the endorsement.

“It implies, incorrectly, that marijuana is an established medication and opens the doors to people and parents ‘experimenting’ with it for all kinds of conditions.”

And when it comes to experimenting with drugs to be used particularly on children, the practice is best left to experts in highly controlled conditions, she added.

“I fully support the parents who are trying to advocate for something they believe will be helpful for their children. But let’s do it the right way — the same way we develop all other medications. We are bound to make mistakes when we try and take short cuts.”

 

Source: medscape.com

 

VariZIG for Varicella Postexposure Prophylaxis: Updated CDC Recommendations.


The new recommendations extend the treatment window from 4 to 10 days postexposure.

 

In the 1960s, zoster immune globulin (immune globulin prepared from patients recovering from zoster) was found to reduce severity of primary varicella as well as attack rates. The development of varicella zoster immune globulin (VZIG) followed in the late 1970s for high-risk patients with varicella exposure. In 2006, VZIG was replaced by a similar product — VariZIG. VariZIG was available as an investigational new drug expanded access protocol until late 2012 and administration was recommended up to 4 days after exposure.

In December 2012, the FDA approved VariZIG for postexposure prophylaxis of varicella in high-risk susceptible individuals. Now, the CDC recommendations extend the treatment window to 10 days postexposure. This recommendation concurs with the current American Academy of Pediatrics recommendations for VariZIG use for the following exposed groups:

  • Immunocompromised patients without evidence of immunity
  • Newborn infants whose mothers have signs of varicella 5 days before to 2 days after delivery
  • Hospitalized premature infants ≥28 weeks’ gestation born to susceptible mothers
  • Hospitalized premature infants <28 weeks’ gestation and birth weight ≤1000 g irrespective of maternal immunity
  • Pregnant women without evidence of immunity

COMMENT

These new recommendations outline the use of passive immunoglobulin (VariZIG) for postexposure prophylaxis of susceptible patients with varicella exposure. The patient groups for which prophylaxis is recommended have not changed from the original VZIG recommendations, but the time for administration of postexposure prophylaxis has been extended to 10 days following exposure. Efficacy is increased if prophylaxis is given as soon as possible after exposure. Vaccination against varicella provides the best protection; however, in patients for whom a live viral vaccine is contraindicated, passive immunity with VariZIG provides protection. VariZIG is available in the U.S. through FFF Enterprises.

Source: NEJM

Researchers assess multiple vitamin D doses in healthy breast-fed infants.


Researchers in Canada suggest that vitamin D supplementation of 1,600 IU per day increased plasma 25-hydroxyvitamin D concentrations to at least 75 nmol/L among 97.5% of infants aged 3 months. However, this dosage also increased concentrations associated with hypocalcemia, according to data.

The literature has established that vitamin D supplementation for infants is required to support healthy bone mineral accretion. However, conflicting recommendations for this patient population have led to further research.

“We have generated strong support using evidence-based dose response studies that the 400 IU dosage is quite satisfactory and that this is recommended now by the Institute of Medicine, Health Canada, Canadian Pediatric Society and the American Academy of Pediatrics,” researcher Hope Weiler, RD, PhD, of the School of Dietetics and Human Nutrition at McGill University in Quebec, said during a media telebriefing. “We also know that the higher dose recommended by the Canadian Pediatrics Society was well received by our infants and did generate a nice response in 25-hydroxyvitamin D, and the upper limits of 1,000 IU and 1,200 IU would be suitable as safety markers across the first year of life.”

According to data from a double blind, randomized study published in JAMA, Weiler and colleagues investigated the efficacy of various dosages of vitamin D supplements in supporting plasma 25-(OH)D concentrations in healthy, breast-fed infants (n=132) aged 1 month. The patients were randomly assigned to oral cholecalciferol (vitamin D3) supplements of 400 IU per day (n=39), 800 IU per day (n=39), 1,200 IU per day (n=38) or 1,600 IU per day (n=16), and they were followed for 11 months.

According to 3-month data, 55% (95% CI, 38-72) of infants in the 400-IU group demonstrated a 25-(OH)D concentration of at least 75 nmol/L vs. 81% (95% CI, 65-91) in the 800-IU group, 92% (95% CI, 77-98) in the 1,200-IU group and 100% in the 1,600-IU group. Due to elevations in 25-(OH)D concentrations, the 1,600 IU dosage was discontinued, researchers wrote. Moreover, the concentration did not continue in 97.5% of the infants at age 12 months in any of the groups.

Further data indicate that all dosages established 25-(OH)D concentrations of at least 50 nmol/L among 97% (95% CI, 94-100) of the infants at 3 months. This continued in 98% (95% CI, 94-100) at 12 months, the researchers wrote.

“Future studies should be larger and, hopefully, be able to detect early, as well as [determine], long-term benefits to bone. We may also consider other health benefits such as the immune system. Our future studies should consider other populations,” Weiler said. “We should also consider those at higher risk for deficiency, whether it’s due to geographic location where a mother’s exposure to sunshine is limited or the infant is born with vitamin D deficiency.”

In an accompanying editorial, Steven A. Abrams, MD, of the department of pediatrics at the US Department of Agriculture/Agricultural Research Service Children’s Nutrition Research Center at Baylor College of Medicine and Texas Children’s Hospital in Houston, said the study did not answer the question of what the target should be for plasma 25-(OH)D concentrations.

“Of importance, higher vitamin D dosages in this study did not lead to improved bone outcomes as reflected by DXA results for bone mineral content,” Abrams wrote.

He suggested that higher vitamin D intake and target plasma 25-(OH)D concentrations should be tested in clinical trials with markedly defined outcomes and precise safety monitoring.

 

Weiler H. JAMA. Theme Issue on Child Health: New research on the optimal dosing and possible adverse effects of different levels of vitamin D supplementation, important for bone health, for infants. Presented at: the JAMA Network 2013 Media Briefing; April 30, 2013; New York.

Disclosure: Abrams reports payment for lectures’/speakers’ bureaus from Mead-Johnson Nutrition and Abbott Nutrition and grants to his institution from Mead-Johnson Nutrition. Gallo reports travel support from CIHR Human Development Child and Youth Health and the American Society for Bone and Mineral Research. Sharma reports consulting fees for analyses prepared for Rodd and Weiler. Jones reports being cofounder and scientific advisory board member for Cytochroma Inc., and for receiving payment for speakers’ bureaus from Genzyme/Sanofi.

 

 

PERSPECTIVE

 

  • I  think it’s a helpful study in terms of the fact that they had different groups of newborn children treated with vitamin D with 400 IU being the recommended dose up to 12 months according to the Institute of Medicine and Endocrine Society guidelines. It was a well-designed study and relevant because vitamin D is a very hot topic right now due to the deficiencies in children and adults.

I agree with the editorial. This group of patients was a mostly white group with relatively high socioeconomic status. In the group that was administered 400 IU per day, researchers found that those infants reached 25(OH)D level of at least 20 ng/mL. That is a big debate. The IOM thinks 25(OH)D levels of 20 ng/mL are adequate for most, and I think a lot of endocrinologists and the Endocrine Society says most people need a level of 30 ng/mL.

This study shows that infants who were administered up to 400 IU per day reached a level of at least 20 ng/mL by 3 months. The whole group did not attain the level of 30 ng/mL, which again is what some endocrinologists think is an optimal level. To achieve a level of 30 ng/mL, perhaps 400 IU is not enough per day for some infants (especially those with darker skin pigmentation or at higher risk for deficiencies).

In addition to looking at the levels or how much vitamin D is needed to achieve a level of 20 ng/mL or 30 ng/mL, they also looked at the bone mineral content but found no significant difference in the groups. I think the editorial comment summed up this point. In treating infants with higher doses of vitamin D corresponding to higher serum levels above 30 ng/mL; does that confer other benefits? There are many early studies now looking at the relationship between vitamin D and asthma, food allergies, incidence of type 1 diabetes and autoimmune disease.

The important point Abrams raises is that we need more long-term studies to see if there is a skeletal benefit in terms of having a higher vitamin D level which would correspond to having a higher dose of vitamin D administered.

  • Dominique Noё Long, MD
  • Instructor of pediatric endocrinology
    The Johns Hopkins Children’s Center
    Baltimore, Md.

PERSPECTIVE

 

  • The strengths and usefulness of the study are the quantification of serum 25-OH vitamin D levels with various doses of vitamin D supplementation. The currently recommended dose of vitamin D, 400 IU daily, was chosen because historically this dose has proven to prevent rickets, which as pediatric endocrinologists, is our main objective. Therefore this study helps provide information in the ongoing debate regarding the optimal serum level of 25(OH) D. Interestingly, all doses of cholecalciferol increased serum levels of 25(OH) D to >50 nmol/L. Higher doses of cholecalciferol correlated with higher levels of 25(OH) D, however no group sustained >97.5% of infants to vitamin D levels >75 nmol/L. No one truly knows the ideal serum level of vitamin D, but this study suggests that >50 nmol/L was sufficient in this patient population. This study also provides information on the safety of higher doses of vitamin D supplementation. It may be harder to extrapolate in the darker-skin pigmented population who may need more vs. the white population. It’s just another piece to the puzzle of the debate on vitamin D.
  • Janet Crane, MD
  • Clinical research fellow in pediatric endocrinology
    The Johns Hopkins Children’s Center
    Baltimore, Md.