• AAP Offers Guidance On Returning to School After Concussion
• Cancer Tests and Treatments with Little to No Value
• Five Pulmonary Medicine Tests and Procedures That Might Not Be Necessary
• Meta-Analysis Finds that ACE Inhibitors are Superior in Patients with Diabetes
• FDA proposing Tighter Restrictions on Hydrocodone Products
• Pediatrics Academy Issues Statement on Adolescent Condom Use
• Imported Spices Commonly Tainted with Salmonella & Filth
• FDA Presents Their Approach to Personalized Medicine
• Consumption of Sugar-Sweetened Beverages Increases Risk for Obesity in Preschoolers
• Ibuprofen, Acetaminophen or Steam for Respiratory Infections?
AAP Offers Guidance On Returning to School After Concussion
By Kelly Young
The American Academy of Pediatrics offers guidance for physicians on helping students return to the classroom after experiencing a concussion.
The recommendations, published in Pediatrics, include the following:
- In the short term, students who have a concussion may need their academic workload adjusted so that the brain is not overtaxed and symptoms do not worsen. Cognitive rest could include a break from electronic devices as well.
- Since most concussion symptoms improve within 3 weeks, academic adjustments can often be made without a formal written plan. If symptoms persist beyond that time, students could benefit from a more detailed medical assessment and a formal education strategy (such as an Americans with Disabilities Act "Section 504" plan).
- Ideally, students would be assisted in their return to the classroom by a multidisciplinary team that includes people from the medical community, school, and family.
- Students should be performing at their baseline academic level before they return to extracurricular activities, including sports.
http://pediatrics.aappublications.org/content/early/2013/10/23/peds.2013-2867.full.pdf+html
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MM: These are simply good advice and should be heeded. Treatments or testing that are more dangerous than the diseases that they are looking at or will have little to no benefit are simply not worth doing. They increase the financial burden to the patient, their survivors and society in general and serve no useful purpose. This is why the USA spends 12 times as much as any other western country for people over 65 for end of life treatments without a significant improvement in comfort or longevity outcomes.
Cancer Tests and Treatments with Little to No Value
By Joe Elia
The American Society of Clinical Oncology has identified a second group of commonly used tests and treatments in cancer medicine that have little or no benefit. The list, part of the American Board of Internal Medicine's "Choosing Wisely" initiative, appears in the Journal of Clinical Oncology.
Briefly, here are this year's "top five" items:
- Don't give antiemetics to patients starting chemotherapies that have low-to-moderate potential for causing symptoms.
- In treating metastatic breast cancer, avoid combination chemotherapy unless the patient's cancer burden needs to be reduced quickly.
- Avoid PET scanning in routine follow-up unless there's "high-level" evidence that the imaging will improve outcomes.
- Don't do PSA testing in asymptomatic men when life expectancy is under 10 years.
- Don't use therapy targeted against a specific genetic aberration unless the patient has specific biomarkers that predict effective response.
http://jco.ascopubs.org/content/early/2013/10/29/JCO.2013.53.3943
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Five Pulmonary Medicine Tests and Procedures That Might Not Be Necessary
By Amy Orciari Herman
The American Thoracic Society and the American College of Chest Physicians (ACCP) have released a list of five things in pulmonary medicine that "physicians and patients should question." The list, published as part of the American Board of Internal Medicine's "Choosing Wisely" campaign, advises the following:
- Don't perform computed tomography (CT) to screen for lung cancer in low-risk patients.
- Don't use CT to evaluate indeterminate lung nodules more frequently than recommended by current guidelines (e.g., those from the ACCP).
- Don't regularly prescribe advanced vasoactive agents approved only for pulmonary arterial hypertension to patients with pulmonary hypertension due to left heart disease or hypoxemic lung disease.
- Don't renew a prescription for supplemental home oxygen for a recently discharged patient without first assessing the patient for ongoing hypoxemia.
- Don't perform chest CT to evaluate for pulmonary embolism when a patient has a low clinical probability and negative D-dimer test results.
http://www.choosingwisely.org/doctor-patient-lists/american-college-of-chest-physicians-and-american-thoracic-society/
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Meta-Analysis Finds that ACE Inhibitors are Superior in Patients with Diabetes
By Amy Orciari Herman
Angiotensin-converting-enzyme (ACE) inhibitors are the antihypertensive treatment of choice in adults with diabetes, according to a BMJ meta-analysis.
Researchers examined nearly 70 randomized trials evaluating 11 antihypertensive regimens in roughly 37,000 adults with diabetes. Outcomes included all-cause mortality, end-stage renal disease, and doubling of serum creatinine.
Among the findings:
- Combination therapy with ACE inhibitors plus calcium-channel blockers appeared most likely to reduce all-cause mortality; beta-blockers showed a significant increase in mortality.
- Only ACE inhibitors significantly prevented the doubling of serum creatinine, compared with placebo.
- Outcomes did not differ significantly between ACE inhibitors and angiotensin-receptor blockers, but ACE inhibitors "consistently showed higher probabilities of being at the superior ranking positions among all outcomes," the authors write.
The authors conclude that ACE inhibitors should be first-line antihypertensive therapy in adults with diabetes, noting that calcium-channel blockers might be added when blood pressure cannot be controlled with ACE inhibitors alone.
http://www.bmj.com/content/347/bmj.f6008
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FDA proposing Tighter Restrictions on Hydrocodone Products
By Kristin J. Kelley
The FDA is recommending that hydrocodone combination products (e.g., hydrocodone plus aspirin or acetaminophen) be reclassified from Schedule III to Schedule II to address concerns over "epidemic proportions" of misuse.
The regulations would increase controls on drugs like Vicodin and Lortab by reducing the number of refills patients can get and preventing doctors from calling in prescriptions over the phone. In an interview with the New York Times, the director of the FDA's Center for Drug Evaluation and Research said the changes could take effect as early as next year. According to the Times' report, the number of deaths from narcotic painkillers has quadrupled since 1999.
The FDA also approved a new hydrocodone product (hydrocodone bitartrate extended-release capsules, marketed as Zohydro ER) for long-term treatment of severe pain. The drug, the first single-entity (i.e., not combined with an analgesic), extended-release hydrocodone product, is a Schedule II substance.
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Pediatrics Academy Issues Statement on Adolescent Condom Use
By Joe Elia
The American Academy of Pediatrics has issued a policy statement, "Condom Use by Adolescents," in Pediatrics.
Among the recommendations are the following:
- Abstaining from intercourse should be encouraged as the "most effective" way to lower risk for sexually transmitted infections.
- Clinicians should promote communication between adolescents and their parents about healthy sexual development.
- They should "actively support and encourage the consistent and correct use of condoms."
- Clinicians should help raise awareness that making condoms available "does not increase the onset or frequency of adolescent sexual activity."
- Condoms should be available for free or at low cost where possible.
- Schools should be considered appropriate sites for condom availability.
http://pediatrics.aappublications.org/content/early/2013/10/23/peds.2013-2821.full.pdf+html
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Imported Spices Commonly Tainted with Salmonella & Filth
By Kelly Young
Salmonella was present in 6.6% of imported spice shipments to the U.S. from 2007 to 2009, according to an FDA report. This prevalence was nearly twice the average for other FDA-regulated foods.
The agency isolated more than 80 different Salmonella serotypes from contaminated spice imports — 6.8% of these had antimicrobial-resistant properties.
The report also found that 12% of imported spice shipments were contaminated with filth, e.g, insects and animal hair.
Most spices consumed in U.S. homes are imported. The FDA identified 14 spice-related illness outbreaks globally from 1973 to 2010. The agency says the reasons for so few reported outbreaks could be that people tend to eat small quantities of spices and foodborne illnesses are underreported.
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm372995.htm
http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafety
Assessment/UCM367337.pdf
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MM: I have to wonder how the FDA can endorse the approach to personal medicine and undermine the practice of compounding. Compounding is about as personalized as medicine can get. It seems that this agency is talking out of both sides of its mouth.
FDA Presents Their Approach to Personalized Medicine
The FDA has outlined its approach for regulating new personalized therapies and devices. Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development, outlines the fundamental ways in which the FDA has modified its traditional approaches to drug and device regulation in the new era of products that are tailored toward specific patient subtypes, rather than broad diagnostic groups.
"We're very, very excited about this report because I think it captures the broad context of what's happening in science and medicine today and the role of the FDA as we enter the era of personalized medicine, and for us, personalized medical product development," FDA commissioner Margaret A. Hamburg, MD, said in a press briefing held at the FDA headquarters.
With the advances in science and technology and the understanding of both the underlying mechanisms and the human response to disease, there are now so many more opportunities to target therapies in exciting ways and really improve the care that can be offered and the effectiveness of treatments. With the approval of trastuzumab (Herceptin, Genentech) for the treatment of HER2-positive breast cancers, the FDA has approved more than 100 drugs that contain specific information about biomarkers in the labeling. Recently, the FDA has approved 4 different cancer drugs for use in patients with tumors that have specific genetic characteristics that are identified by companion test kits. Two recent approvals also demonstrate the extent to which science and technology are advancing personalized medicine and influencing the way the agency does business. Kalydeco (Vertex Pharmaceuticals), is the first-ever drug to address the underlying cause of cystic fibrosis among patients with a specific gene mutation.
http://www.medscape.com/viewarticle/813401
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MM: It's not a huge surprise that anyone at any age who is drinking sugar sweetened beverages (SSB's) would be at increased risk of obesity. A surprising statistic is that children seem to have a delayed response to developing obesity from 2 to 4 years of age. This is even more distressing as parents may not realize the damage that is being done at these earlier ages until obesity establishes a visible presence.
Pediatrics 2013 Sep; 132:413
Consumption of Sugar-Sweetened Beverages Increases Risk for Obesity in Preschoolers
This is the first study to link consumption of sugar-sweetened beverages with obesity/overweight in preschoolers.
Consumption of sugar-sweetened beverages (SSBs) is associated with weight status in older children, but what about preschoolers? Investigators examined parents' reports of their children's consumption of SSBs from a representative prospective longitudinal survey of 9600 U.S. preschool children (age range, 2–5 years) born in 2001.
At ages 2, 4, and 5 years, a significantly greater proportion of children drinking ≥1 serving (8 oz) of an SSB daily had obese or overweight mothers compared with children who drank <1 serving daily. In addition, 4- and 5-year-olds who drank SSBs daily watched more television and drank less milk. SSB consumption and overweight/obesity were not significantly associated at age 2 years, but regular SSB drinkers were more likely to be obese at age 5 years. Body-mass index (BMI) was positively associated with SSB consumption at ages 4 and 5 years. Daily consumption of SSBs at age 2 years was associated with a more rapid increase in BMI score by age 4 years.
Comment: This study shows a convincing link between obesity and consumption of sugar-sweetened beverages in toddlers and preschool-aged children. The authors discuss efforts to ban the sale of large-volume servings of sugar-containing soda in the U.S. Given the epidemic of early childhood obesity, water and milk should be the only fluids consumed during childhood.
Citation(s): DeBoer MD et al. Sugar-sweetened beverages and weight gain in 2- to 5-year-old children. Pediatrics 2013 Sep; 132:413.
(http://dx.doi.org/10.1542/peds.2013-0570)
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MM: Although the conclusions of this study seem mottled, a conclusion that seems to have been reached is that all 3 modalities showed similar to no improvement at 2-4 days and that regular dosing of either acetaminophen or Ibuprofen was detrimental. Instead, either medication should only be used as needed rather than as "pre-treatment", which is frequently recommended.
Ibuprofen, Acetaminophen or Steam for Respiratory Infections?
Steam inhalation and ibuprofen are not more likely than acetaminophen to relieve acute respiratory symptoms in most patients, according to a BMJ study.
Nearly 900 patients aged 3 and up presenting with acute respiratory infections were randomized to 12 groups that offered advice on the following:
- drugs: acetaminophen, ibuprofen, or alternating between the two
- dosing: regular (4 times daily for at least 3 days), or as needed
- steam: inhale 15 minutes daily, or no steam
Patient-reported symptom severity on days 2 to 4 did not differ significantly across the groups. Children and patients with lower respiratory infections were more likely to benefit from ibuprofen. However, new or unresolved symptoms or complications were more common with ibuprofen (20%) or alternating therapy (17%) than acetaminophen (12%).
The authors conclude that clinicians should not routinely recommend steam or regular medication dosing, adding: "They could consider ibuprofen use in patients with chest infections and those aged <16 who might selectively benefit."
http://www.bmj.com/content/347/bmj.f6041
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