Posted On: February 28, 2012

CT Scans for All Kids with Head Injuries?

From high-profile former NFL players to soldiers returning from Afghanistan, the emerging picture of head trauma is not pretty. And of course the lingering, often-delayed effects of traumatic brain injury (TBI) aren’t limited to adults.

We’ve talked about children at risk of concussion when they play sports, and how manufacturers are developing “anti-concussion” athletic equipment.

Writing on, malpractice attorney Maxwell S. Kennerly suggested that some practitioners still aren’t taking head injuries to children seriously enough.

Last year, he noted, the Centers for Disease Control and Prevention (CDC) reported “a growing awareness among parents and coaches, and the public as a whole, about the need for individuals with a suspected TBI to be seen by a health-care professional.” He pointed to the CDC’s Heads Up initiative as exemplary of efforts to raise consciousness that seeing stars isn’t a badge of athletic honor, it’s a reason to seek medical care.

What remains questionable, Kennerly wrote, is how prepared emergency and primary care physicians are to handle the increased number of head trauma cases they’ll see as a result of greater awareness of the problem.

“Viewed through a narrow lens, the solution to a suspected brain injury is obvious,” he wrote. “[I] f a kid complains about anything relating to their head, give them a CT scan. But CT scans come with their own costs and risks, not least exposing a developing brain to a year’s worth of background radiation.”

Too often medicine overtreats patients because technology enables it, insurance pays for it and/or doctors are worried about being challenged if they fail to perform every test within reach. Often a more conservative approach is better for the patient.

But when it comes to kids and head injuries, in deciding whether to order a CT scan for a kid with new head trauma, Kennerly says the conservative treatment approach is wrong.

“I’m not here to tell you where the CT / no-CT line should be drawn,” Kennerly claimed. “I can tell you, however, how I would draw that line as a medical malpractice lawyer when a parent comes in and tells me their doctor didn’t order a CT scan after a minor head trauma and their child later developed serious sequelae [i.e., a brain injury]."

In the world of medical malpractice, such a circumstance is known as “failure to diagnose.” As Kennerly explained, laypeople—like jurors—might well respond to the concept of incremental risk a witness might offer to defend against the charge of failure to diagnose. “One head CT scan,” the witness might say, “has more radiation than 20,000 trips through the TSA scanner at the airport.”

That sounds scary. But is it scarier than risking chronic, lifelong problems with the ability to think, loss of memory, headaches, attention deficit, mood swings and the other markers of brain injury?

Kennerly cited an article published in the January issue of Critical Decisions in Emergency Medicine, “Evaluation of Minor Head Trauma in Pediatric Patients," that argues for CT scans for children who present with any evidence of brain trauma.

If you’re the parent of a child who has fallen from a great height, who has emerged woozy from a collision in soccer, who claims his or her vision is blurred from a bang on the noggin, take him or her to your physician or emergency room immediately. And if the child doesn't show full recovery of normal consciousness very quickly, without any symptoms of brain trouble, a CT scan could be in order.

A British website offers guidelines for CT scans for anyone younger than 16 with a head injury, and the CDC's Heads-Up site helps observers spot the signs of concussion. They are:

  • loss of consciousness;

  • loss of memory;

  • abnormal drowsiness or sluggishness;

  • nausea or vomiting;

  • bruise, swelling or laceration on the head, behind the ears;

  • bruising around the eyes ("panda" eyes);

  • fluid leakage from ears or nose;

  • confused, dazed or stunned appearance;

  • personality changes;

  • headache;

  • problems balancing or abnormal clumsiness;

  • double or blurry vision; or

  • abnormal sensitivity to light or noise.
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Posted On: February 19, 2012

Cancer Drug's Short Supply Moves to Critical Stage

After it failed an inspection in November by the FDA, Ben Venue Laboratories in Ohio was shut down. No one in his or her right mind would want to take drugs manufactured in a place where mold was growing on the walls and machinery rust was falling into vials.

Now, the toll of the lab’s decrepit state might have to be paid by children with acute lymphoblastic leukemia (ALL) and a type of bone cancer, osteogenic sarcoma. They rely on a longtime cancer drug, methotrexate, that, as NPR reported, can mean the difference between death and cure.

Ben Venue was a principal supplier of injectable methotrexate. Now, its shortage is acute, the latest in long line of critical drug shortages. We’ve written often on the topic, and what is being done to address it.

According to NPR, hospitals throughout the country are “perilously close” to exhausting their supplies of the kind of methotrexate that treats ALL and osteogenic sarcoma. In a few weeks, substituting or delaying therapy might be forced on some patients. Their doctors aren’t certain how that will affect their chances of a cure, which are 9 in 10 with the right treatment.

One expert on drug shortages told NPR that most people don’t realize how many U.S. drug plants are in extreme disrepair, especially those that manufacture generic drugs. Ben Venue claims to have invested $250 million recently to upgrade its facilities, but it’s unclear when it will reopen. That lab also was the sole manufacturer of Doxil, an ovarian and breast cancer drug that’s now unavailable.

But there’s cause for hope. The FDA said the methotrexate and Doxil crises soon may be over. Three other manufacturers are increasing production of the specific kind of methotrexate at issue, and they told the feds that additional supplies should be available within weeks.

The FDA is considering licensing a foreign company to make Doxil, a measure it has taken eight times in the last year to address other drugs in critical shortage.

And last week Ben Venue posted a message on its website that it was working with the FDA to expedite the availability of methotrexate and immediately would begin releasing a limited supply to oncology clinics, hospitals and pediatric facilities. "We hope this supply will help address near-term patient needs while other companies licensed to manufacture methotrexate increase production," the statement read.

Doctors were optimistic about restocking hospital supplies of methotrexate, but, as one told NPR, “[T]his is not the last shortage we’ll have to cope with.”

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Posted On: February 13, 2012

Panel Recommends Suicide Warning Be Added to ADHD Drug Label

A panel of pediatric experts has recommended that the FDA change the label for Focalin to address the risk of suicidal thoughts by children, according to Reuters.

The drug is prescribed for attention deficit disorder and is manufactured by Novartis AG. It was approved for children 6 and older in 2001.

Children with ADHD are excessively restless, impulsive, easily distracted and often have behavioral issues. Symptoms generally are relieved with behavioral therapy and medication (at least short term; the long term benefits of medication are less clear).

The FDA is not required to follow the advice of its panels, but usually does. It is required to hold regular advisory meetings to review the safety of drugs used by children. The panel also recommended that Focalin's label acknowledge the risk of anaphylaxis, an allergic reaction, and angioedema, a type of swelling beneath the skin.

The current label for Focalin advises patients about psychotic or manic side effects, but does not mention suicidal thoughts.

The FDA received eight reports of suicidal thoughts by children or adolescents who took the drug over the last six years. This risk did not present during the clinical trials of the drug, and the number of such reports is tiny in comparison to the number of patients taking it. If your child is taking Focalin, he or she shouldn’t stop taking it. But do consult your pediatrician.

Diagnoses of ADHD (attention deficit hyperactivity disorder) have boomed in recent years; an estimated 3 to 5 kids in 100 are affected. Some experts question whether these diagnoses are made too quickly and drugs prescribed too easily. We’ve addressed the suitability of prescription drugs for ADHD.

According to Reuters, approximately 2.7 million people in the U.S. have prescriptions for ADHD drugs. Approximately 1.8 children received prescriptions for Focalin or its generic versions from 2005 to 2011.

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Posted On: February 7, 2012

A Doctor's Advice to Parents About Vaccinations

There’s been a lot of chatter in recent years about childhood vaccinations and their alleged potential to do more harm than good. Most of the cautionary tales shed more heat than light, and endanger the children they purport to protect.

Writing in the New England Journal of Medicine last week, Dr. Douglas S. Diekema published a thoughtful commentary about the struggle some parents have with the idea of vaccinations and how the medical community can encourage people to get their kids appropriately protected with vaccines.

He recounted the story of a mother who wanted to follow an “alternative” schedule versus that driven by best medical practice. The pediatrician went along, prompting the mother to believe that the recommended schedule was no better than her alternative.

Thousands of parents are like her. Some choose not to vaccinate their children at all. Some have religious or philosophical reasons, some want to spare their children from uncomfortable procedures, some just don’t believe the benefit outweighs the risk. Many have no experience with or knowledge of serious vaccine-preventable diseases like polio or measles.

But that doesn’t mean there aren’t contemporary health threats that vaccines neutralize. In 2010, California reported more than 9,000 cases of pertussis (whooping cough) — more than the state had seen since 1947. Nearly 9 in 10 involved infants younger than 6 months, a group too young to be adequately immunized and largely dependent on “herd immunity” (when vaccinating a significant portion of a population imparts protection for all members who have not developed immunity). Ten of the California infants died from the infection.

Because some parents—those with religious or strong personal beliefs—probably aren’t capable of being persuaded to vaccinate their children, whether for their own good or the good of society—Diekema focuses on the parents who question the safety of vaccines or have logistic or financial concerns.

1. Eliminate money barriers and disincentives to vaccination. Even small co-payments or fees pose substantial barriers for some families. Public health clinics are one option, but can require travel and time away from work — all disincentives to following through. “Incentives can take several forms, including reduced insurance rates, tax rebates or direct payments,” he writes.

2. Strengthen and enforce school-entry requirements. Such requirements effectively boost immunization rates for school-age children, but vary widely by state in terms of exemptions allowed. “All states allow exemptions for medical reasons, 48 for religious reasons and 20 for philosophical reasons.”

Acknowledging that eliminating exemptions for religious and personal beliefs would encounter substantial resistance, Diekema remains resolute. “The exemption process should not be easier or less costly than the vaccination process. Obtaining a religious or personal-belief exemption should at least require a visit to the physician's office, including counseling on the risks posed by remaining unvaccinated; insurance should pay for such visits.” States could require exemption requests to be signed by both parents if both are legally authorized. “Although such measures wouldn't change the stance of the most resistant parents, they would eliminate many exemptions sought because of convenience rather than conviction.”

Diekema also points out that lax enforcement of school-entry requirements communicates that vaccination is merely bureaucratic rather than a way to ensure students' safety.

3. Address misinformation about vaccines promptly and aggressively. “False or misleading information about vaccination is widely dispersed by a few influential individuals, self-described vaccine-safety advocates and some clinicians. Public health officials and professional organizations should respond swiftly to dishonest or unbalanced portrayals of vaccination.”

4. Clinicians, health-care organizations and public health departments must be persuasive. “Data and facts,” Diekema states, “no matter how strongly supportive of vaccination, will not be sufficient to compete with the opposition's emotional appeals. The use of a compelling story about a single victim of vaccine-preventable illness is far more likely than data to move an audience to action.”

This outreach, he says, is the responsibility of primary care providers. “Parents will be most receptive to considering vaccination if they believe their provider is primarily motivated by the welfare of the individual child rather than an abstract public health goal.” As we’ve said over and over, a doctor’s willingness to listen respectfully, encourage questions and respect parental concerns are essential for any professional health-care provider. Accurate information about both risks and benefits is crucial to maintaining trust, and must include a discussion of risks associated with both remaining unvaccinated and delaying certain vaccines.

5. Set an example. “We're unlikely to achieve optimal vaccination rates until health-care professionals comply with vaccine recommendations for themselves and their children. The unwillingness of many clinicians to submit to influenza vaccination each year is disgraceful, sets a poor example and gives patients reason to question the safety and efficacy of vaccines.”

We couldn’t agree more: Doctor, heal thyself.

First published on Technorati.

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