• Compounding Group Formed by Former HHS and FDA Officials
• Congress Considering Oversight of Compounding
• The Health Perks of Coffee
• FDA Approves Device to Help Diagnose ADHD. Skeptic Weighs In
• Clawing Your Way Back: Why Nails Are So Important
• Can Talking About Healthy Eating Reduce Adolescent Disordered Eating Behaviors
• Death, How and When to Start a Conversation About It
• Acute Bacterial Sinusitis in Children
• Physical Punishment of Children Linked to Obesity, Arthritis in Adulthood
• Obesity Linked with Sensorineural Hearing Loss in Adolescents
• Longer Duration of Obesity Associated With Increasing Risk for Subclinical Heart Disease
• Constipation Does Not Cause Colorectal Cancer
• Penicillin for Infective Endocarditis — Dose Frequently!
• The Human Gut Virome
• Pertussis Vaccine Only 'Moderately Effective' During Outbreak
MM: The creation of this lobbying group is only thinly disguised as a consumer advocacy group. It is the Big Pharma Industry and private interest being pushed by money. It totally disgusts me that Tommy G Thompson and Sarah Sellers should be able to pander to these big money sources and work to take away the rights of consumers. Should these lobbying efforts get traction it could cost CMS and taxpayers added hundreds of millions of dollars a year for conventional medications compared to many of those that are compounded daily.
Citizens must contact their senators and congressional representatives in Washington to express their disapproval of progress on Senate Bill (S 959)or we may all lose our ability to obtain compounded medications.
Compounding Group Formed by Former HHS and FDA Officials
Compounding industry critic and former Health and Human Services Secretary Tommy G. Thompson has teamed up with Sarah Sellers, previously a FDA employee, now working as an industry consultant, to launch the Working Group on Pharmaceutical Safety. This new group is "lobbying senators to toughen" the proposed bill that the Senate Health, Education, Labor and Pensions Committee approved in May to bolster the regulation of compounding pharmacies. Thompson's group "wants senators to ensure that patients receiving compounded drugs have a legitimate medical need for them, such as an allergy to an ingredient in a brand name or generic medicine."
http://www.cq.com/login?jumpto=doc/weeklyreport-4314366
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Congress Considering Oversight of Compounding
Congress is looking at the issue of whether and where to draw the line between state and federal oversight of large-scale compounding pharmacies. Some say that there now appears to be some agreement that the FDA needs some clear authority over compounding manufacturers; those pharmacies that compound very large quantities for interstate shipment in advance of a patient prescription.
However, a hearing before the House Energy and Commerce Health Subcommittee shed more light on the intricacies associated with such regulation. For example, they are unwilling to tighten regulation of the pharmacies due to the importance of the service that the compounders provide to physicians treating patients who don't respond to or cannot tolerate medications mass produced by brand and generic pharmaceutical companies. Concurrently, Congress doesn't want to be seen as allowing poor oversight of large-scale compounders.
http://www.medpagetoday.com/Washington-Watch/FDAGeneral/40523
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MM: Apparently percolated coffee is the potentially problematic source relative to cholesterol. Why this is the case is up for grabs, I simply don't know. For those with osteoporosis concerns it appears that it is still important to have sources of calcium in their diets. It just goes to show that the more we learn, the less we understand.
The Health Perks of Coffee
By Kelly Young
Good news for coffee drinkers: a review in the Journal of the American College of Cardiology finds that overall, moderate consumption of coffee has a neutral-to-beneficial effect on cardiovascular health. About three cups of coffee daily "appears to be safe and harmless for healthy adults," the review concludes.
The possible health benefits include reduced risks for ischemic stroke, type 2 diabetes, and mortality. Boiled coffee was associated with increased total and LDL cholesterol levels, but filtered coffee did not have the same effect.
The review notes that while high levels of caffeine consumption may increase urinary calcium excretion, the amount of calcium lost in drinking one cup of coffee could be offset by adding two tablespoons of milk. It did not mention the effects of excessive half-and-half consumption.
http://content.onlinejacc.org/article.aspx?articleid=1712575
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MM: Almost everyone knows what a geek I am when it comes to cool new diagnostic tools and toys but does this tool really help us make an otherwise observational diagnosis or are we merely able to rule out a possible cause of ADHD yet treat it the same way as if the diagnosis is mechanically confirmed? This machine is probably a waste of money and may serve to act as a tool for insurance companies to exclude a ADHD diagnosis and deny coverage.
FDA Approves Device to Help Diagnose ADHD. Skeptic Weighs In
By Joe Elia
An EEG-like device that measures brain waves to assess attention-deficit/hyperactivity disorder in children and adolescents has received FDA approval.
Called the "NEBA system" (for Neuropsychiatric EEG-Based Assessment Aid), the device measures the ratio of theta to beta waves, with higher quotients found in those with ADHD. In a news release, an FDA official said the device "along with other clinical information may help health care providers more accurately determine if ADHD is the cause of a behavioral problem."
The New York Times quotes a skeptical ADHD researcher, who says that traditional diagnostic methods are relatively accurate. "We're not going to run out and buy one of these machines to do diagnoses, because it is totally unnecessary," he told the Times.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm360811.htm
http://www.nytimes.com/2013/07/16/health/brain-test-to-diagnose-adhd-is-approved.html?_r=0
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MM: Ok, I was a bit down on the idea of a machine to determine whether a patient truly has ADHD versus some other similar diagnosis but who could possibly not think that regenerating a person's own limbs isn't cool? Not a chameleon or a frog or a starfish has to worry too much about losing a part of their body since they typically grow it back but who would have ever imagined that we could see this same trait in mammals. Imagine the difference this could make for people in major accidents or for soldiers injured in battle or from IED's. The world is a fascinating place!
Nature 2013 Jul 11; 499:228
Clawing Your Way Back: Why Nails Are So Important
This groundbreaking work might point to a molecular path for regenerating limbs.
The distal tips of mammalian digits can regenerate following amputation, but only when the nail apparatus is intact. Coordinated regrowth of nail and distal phalanx involves nail epithelial cells and undifferentiated mesenchymal cells that form the “blastema,” which subsequently differentiates to reform the distal digit.
Takeo and colleagues explored the role of nail epithelial cells in tip regeneration by first localizing nail epithelial stem cells (NSCs). They used a clever trick in mice allowing every progenitor cell of a given keratin-14 (K14+)–expressing basal cell to be labeled and followed in space and time. They discovered that K14+ cells from the proximal nail matrix persisted for over 5 months, giving rise to the proximal and distal nail plates and bed cells. Progeny of distal matrix K14+ basal cells, by contrast, persisted for less than 3 months. The investigators concluded that long-lived NSCs reside in the proximal fold.
Next, they proved that the highly conserved Wnt signaling pathway — involved in cell differentiation, proliferation, and axis patterning in animals from invertebrates to humans — is required for nail differentiation. Upon amputation of the distal digits, mice lacking Wnt signaling failed to reinnervate and regenerate bone. Conversely, the inability to regenerate the digit following proximal amputation could be partially overcome by forcing elevated Wnt expression in the nail
Comment: This groundbreaking work shows that the proximal nail matrix is the privileged site where nail stem cells reside and that Wnt signaling directs nail differentiation and coordinated reinnervation and regeneration of bone. These findings offer a potential molecular path for regenerating limbs following traumatic or developmental defects.
Citation(s): Takeo M et al. Wnt activation in nail epithelium couples nail growth to digit regeneration. Nature 2013 Jul 11; 499:228.
(http://dx.doi.org/10.1038/nature12214)
http://www.ncbi.nlm.nih.gov/pubmed/23760480?access_num=23760480&link_type=
MED&dopt=Abstract
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MM: I like the notion of discussing with our families the notion of healthy eating habits rather than focusing directtly on weight and body image. I think that this is a more productive and positive approach and this research seems to support that.
JAMA Pediatr 2013 Jun 24
Can Talking About Healthy Eating Reduce Adolescent Disordered Eating Behaviors
When parents discussed healthy eating rather than dieting and weight, adolescents were less likely to report disordered eating.
How should parents discuss eating habits and weight with their teenagers? To examine this question, investigators analyzed data from two linked population-based studies involving 2300 ethnically diverse adolescents (mean age, 14 years) and 3500 parents or caregivers. Parents were classified as having no conversations about eating (healthy or otherwise) or weight with their children, healthful eating conversations only, or conversations about weight only.
Among nonoverweight adolescents, parental discussions about healthy eating had little or no effect on adolescent reports of dieting, unhealthy or extreme weight control behaviors, or binge eating, compared with no parental discussions about eating or weight. In contrast, parental conversations about weight increased the probability that nonoverweight adolescents would report such behaviors. Among overweight adolescents, parental discussions about healthy eating lowered the probability that adolescents reported any weight-control behavior while conversations about weight increased the risk, compared with overweight adolescents whose parents did not talk about eating or weight. Conversations about weight with both parents was associated with more adolescent reports of some, but not all, weight-control behaviors in both nonoverweight and overweight adolescents compared with conversations with only one parent.
Comment These results are quite straightforward. Parents should avoid conversations about weight or size (or talking about eating differently to lose weight or avoid gaining weight). Rather, the dialogue should center on healthy eating, which could involve the adolescent's eating patterns or, perhaps even better, that of the entire family. Because the development of weight-control behaviors is complex, such conversations will not completely eliminate the possibility that adolescents will adapt unhealthy weight-control behaviors, but hopefully discussions about healthy eating will reduce the risk somewhat
Citation(s): Berge JM et al. Parent conversations about healthful eating and weight. JAMA Pediatr 2013 Jun 24; [e-pub ahead of print].
(http://dx.doi.org/10.1001/jamapediatrics.2013.78)
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MM: Discussions about death are not something that most of us look forward to but are certainly important since we all must encounter it in our lifetimes. It is better to be prepared for dealing with the myriad of legal, social,. emotional and financial issues that will occur in a pro-active rather than a reactive manner.
Death, How and When to Start a Conversation About It
By Joe Elia
Hospitalized patients and their families complain about the quality of end-of-life care, and a review in the Canadian Medical Association Journal offers guidance on talking with patients and their families about their preferences and what to expect.
The review suggests that such conversations about death should be thought of as a process rather than a single event; and if you would not be surprised that the patient died within the next year, it's best to start that process. In doing so, the authors advise that family members be invited to the conversation.
The physician should be prepared to offer prognostic estimates (the authors provide links to helpful online estimators) while acknowledging uncertainty. As important, learn the patient's values and record them clearly in the medical record.
The authors offer two seemingly less important, perhaps obvious points for these discussions: first, sit down, and second, make eye contact.
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MM: The take away from these new guidelines is to wait and observe first and use antibiotics as a last resort and judiciously. Also, use careful assessment of which antibiotic to use so that "super infections" are less likely to develop. Ultimately an ounce of prevention is worth a pound of cure so good hand hygiene along with vitamin D and vitamin C supplementation as a means of strengthening the immune system should be in place to reduce risks of infection in the first place.
Pediatrics 2013 Jul; 132:e262
Acute Bacterial Sinusitis in Children
The AAP updates management guidelines for diagnosis and treatment of sinusitis
American Academy of Pediatrics
Purpose and Objective: Update of 2001 recommendations for diagnosis and management of acute sinusitis in children between ages 1 and 18 years.
What's Changed:
- Addition of diagnosis based on clinical presentation of worsening course
- Watchful-waiting option in those with persistent illness
- Imaging should not be used to diagnose acute bacterial sinusitis
Key Recommendations:
Diagnosis:
Diagnosis of acute sinusitis can be made when a child with acute upper respiratory infection (URI) has persistent illness (>10 days), including nasal discharge of any quality and/or daytime cough, or worsening course of URI symptoms, or severe onset of fever with purulent nasal discharge lasting at least 3 days.
Physical exam findings are not helpful in differentiating sinusitis from uncomplicated URI.
Imaging should not be used to diagnose acute bacterial sinusitis because children with uncomplicated URIs may have abnormal plain films, computed tomography (CT), and magnetic resonance images (MRI). Contrast CT and/or MRI of the paranasal sinuses are indicated in children with orbital or central nervous system complications.
Management:
- Antibiotics are indicated in children with severe sinusitis or worsening symptoms. Outpatient observation for 3 days prior to antibiotics can be considered in those with persistent illness.
- Amoxicillin or amoxicillin/clavulanate is recommended first-line treatment for acute bacterial sinusitis because Streptococcus pneumoniae, nontypable Haemophilus influenzae, and Moraxella catarrhalis are the most common causative organisms in acute bacterial sinus disease. Decisions about antibiotic choice should be individualized for each patient. Amoxicillin is the preferred antibiotic in children aged >2 years with mild symptoms who are not in child care and have not received antibiotics in the previous month. For others, amoxicillin/clavulanate with high-dose amoxicillin is recommended. Amoxicillin dose (45 mg/kg vs. 80–90 mg/kg) should be dictated by local pneumococcal-resistance rates.
- Penicillin-allergic children can be prescribed an oral second- or third-generation cephalosporin (cefdinir, cefuroxime, or cefpodoxime), and consultation with an allergist may be warranted for children with anaphylaxis to penicillin. Trimethoprim-sulfamethoxazole and azithromycin are not recommended because of high resistance rates.
- Duration of therapy should be individualized, but a minimum of 10 days, or 7 days after symptom resolution, is proposed. Reassess patients after 72 hours to confirm improvement.
- No recommendations are made for use of adjuvant therapies (including intranasal corticosteroids, saline nasal irrigation, decongestants, and antihistamines).
Prevention:
- Influenza vaccine and PCV-13 should be administered to all children at the recommended ages.
- Treat appropriately conditions that promote sinusitis (e.g., allergic rhinitis and gastroesophageal reflux
Comment This guideline provides evidence-based recommendations that support the clinical diagnosis of sinusitis and allow for a “wait-and-see” option for patients with mild disease. The recommendation to avoid imaging in uncomplicated disease is an important one and will help reduce unnecessary radiation exposure. Amoxicillin as first-line therapy for most children is consistent with otitis media treatment recommendations and is a key component of judicious antibiotic use.
Citation(s): Wald ER et al. Clinical practice guideline for the diagnosis and management of acute bacterial sinusitis in children aged 1 to 18 years. Pediatrics 2013 Jul; 132:e262.
(http://dx.doi.org/10.1542/peds.2013-1071)
http://pediatrics.aappublications.org/content/132/1/e262?ijkey=
97828f3c9cec44f2366c7ed0c33b7c0f2ed39f56&keytype2=tf_ipsecsha
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Physical Punishment of Children Linked to Obesity, Arthritis in Adulthood
By Kelly Young
Harsh physical punishment in childhood is associated with adverse physical health outcomes in adulthood, according to a cross-sectional study in Pediatrics.
Researchers surveyed over 30,000 U.S. adults about whether they had experienced harsh physical punishment (e.g., pushing, grabbing, shoving, slapping, or hitting) as children. After adjusting for education, family history of dysfunction and mental disorders, and other variables, adults who reported receiving harsh physical punishment as children were at increased risk for having arthritis (adjusted odds ratio, 1.25) and obesity (OR, 1.20). The risk for cardiovascular disease was of borderline significance. Past studies have found that childhood mistreatment is linked to dysregulation of the body's stress response system.
For physicians advising parents about discipline, the authors write: "It is recommended that physical punishment not be used with children of any age." They instead recommend "positive parenting approaches and nonphysical means of discipline."
http://pediatrics.aappublications.org/content/early/2013/07/10/peds.2012-4021.abstract
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Laryngoscope 2013 Jun 11
Obesity Linked with Sensorineural Hearing Loss in Adolescents
Obesity nearly doubled the risk for unilateral low-frequency hearing loss
Hearing loss is not a well-known adverse health consequence of obesity in adults. Researchers examined this association in 1488 adolescents aged 12 to 19 years using cross-sectional data from the 2005–2006 National Health and Nutrition Examination Survey.
Body-mass indexes from the 5th to 85th percentile were considered normal weight, from 86th to 94th percentile were overweight, and ≥95th percentile were obese. Compared with normal-weight teens, obese teens had a greater prevalence of low-frequency unilateral sensorineural hearing loss (SNHL; >15 dB, 15% vs. 8%) as well as bilateral low- and unilateral and bilateral high-frequency SNHL, but these trends were not statistically significant. In multivariate analysis that controlled for numerous risk factors (e.g., smoke exposure, poverty, various noise exposures), obesity was independently and significantly associated with a 1.85 increased risk for unilateral low-frequency SNHL
Comment: Hearing loss has not previously been on my radar as a comorbidity of obesity. Although these data do not address whether or how obesity leads to hearing loss, the prevalence of hearing loss in adolescents is rising, most likely due to noise exposure (NEJM JW Pediatr Adolesc Med Sep 8, 2010), so it seems prudent to counsel teens about risk factors for hearing loss, including obesity.
Citation(s): Lalwani AK et al. Obesity is associated with sensorineural hearing loss in adolescents. Laryngoscope 2013 Jun 11; [e-pub ahead of print].
(http://dx.doi.org/10.1002/lary.24244)
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Longer Duration of Obesity Associated With Increasing Risk for Subclinical Heart Disease
By Amy Orciari Herman
The longer the duration of obesity, the greater the risk for subclinical atherosclerosis, a JAMA study finds.
Nearly 3300 initially nonobese young adults were followed for up to 25 years. Waist circumference and BMI were measured every few years, and coronary artery calcification (CAC) was assessed with computed tomography scans at year 15, 20, or 25.
Some 40% of participants developed overall or abdominal obesity. The duration of obesity was strongly associated with the presence and extent of CAC. For example, CAC was found in about 39% of those with more than 20 years of overall or abdominal obesity, versus 25% of those with no obesity. CAC risk increased significantly with each additional year of obesity.
The researchers conclude: "Our findings suggest that preventing or at least delaying the onset of obesity in young adulthood may substantially reduce the risk of coronary atherosclerosis and limit its progression later in life."
http://jama.jamanetwork.com/article.aspx?articleid=1713590
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Am J Gastroenterol 2013 Jun; 108:894
Constipation Does Not Cause Colorectal Cancer
Clinicians should feel confident in communicating this message to patients who inquire.
Gastroenterologists are often asked whether constipation is a risk factor for colorectal cancer. In the current meta-analysis, investigators analyzed data from cross-sectional surveys, cohort studies, and case-control studies that evaluated the possible association between constipation and colorectal cancer.
Twenty-eight studies were considered eligible, including 8 cross-sectional, 3 cohort, and 17 case-control studies. In the cross-sectional surveys comprising 8866 patients who underwent diagnostic colonoscopy for symptoms, a primary indication of constipation versus other indications for colonoscopy was associated with a lower prevalence of colorectal cancer (pooled odds ratio, 0.56; 95% confidence interval, 0.36–0.89). In the three cohort studies comprising 189,038 patients, the pooled odds ratio for colorectal cancer in constipated patients versus non-constipated patients was 0.80 (95% CI, 0.61–1.04). In the 17 case-control studies comprising 62,594 patients, the pooled odds ratio for constipation in patients with versus without colorectal cancer was 1.68 (95% CI, 1.29–2.18); however, significant heterogeneity between studies was observed, and possible publication bias was a concern
Comment: Overall, these results do not support constipation as a risk factor for colorectal cancer. Poor study quality, publication bias, and recall bias raise doubts about the association observed in the case-control studies. Patients who ask about this issue can be confidently told that no convincing evidence exists to support constipation as a risk factor for colorectal cancer.
Citation(s): Power AM et al. Association between constipation and colorectal cancer: Systematic review and meta-analysis of observational studies. Am J Gastroenterol 2013 Jun; 108:894.
(http://dx.doi.org/10.1038/ajg.2013.52)
http://www.ncbi.nlm.nih.gov/pubmed/23481143?access_num=23481143&link_
type=MED&dopt=Abstract
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MM: It's nice to know that penicillin still has a place for potentially life-saving use but it's interesting that although we have always been aware of the relatively short half life of the drug it has not been commonly taken into consideration in life threatening situations such as endocarditis. You have to wonder if this was due to clinical ignorance, ease of administration or operational monetary concerns or a combination. In any case, hopefully this information will become more widely known and acted upon in the future.
J Antimicrob Chemother 2013 Jun 13
Penicillin for Infective Endocarditis — Dose Frequently!
In an observational study on streptococcal endocarditis, a successful outcome was nearly three times more likely with a 4-hourly dosing interval than with a 6-hourly one.
Although penicillin remains the cornerstone of antibiotic treatment for streptococcal infective endocarditis, guidelines have differed with respect to the suggested dosing interval. Whether such differences affect outcome is unclear. Now, researchers at the University of Leeds, England, have published data from a retrospective series of 212 patients with streptococcal endocarditis treated at their institution between 2000 and 2011 that shed some light on this clinical problem.
Sixty percent of the 150 patients treated with a 4-hourly penicillin regimen were cured compared with 37% of the 62 patients treated with a 6-hourly regimen. A 4-hourly dosing interval was the only treatment-related parameter significantly associated with successful initial therapy (odds ratio, 2.79; 95% confidence interval, 1.43–5.62). Evidence of abscess or severe valvular regurgitation on initial echocardiography decreased the likelihood of successful initial penicillin therapy (OR, 0.30; 95% CI, 0.13–0.66). In a stepwise multivariate regression analysis, patient age, sex, Charlson score, renal impairment, valve type affected, valve location, total daily penicillin dose, penicillin MIC of the isolate, and concurrent prescription of gentamicin had no effect on outcome
Comment: Penicillin is a safe antibiotic with a narrow spectrum and good activity against the streptococci that cause endocarditis. The study findings are not really surprising, given penicillin's short half-life and the shorter periods above the minimum inhibitory concentration with less-frequent dosing. Interestingly, this study did not suggest a positive effect of gentamicin on endocarditis outcomes — another area of controversy.
Citation(s): Sandoe JAT et al. What is the effect of penicillin dosing interval on outcomes in streptococcal infective endocarditis? J Antimicrob Chemother 2013 Jun 13; [e-pub ahead of print].
(http://dx.doi.org/10.1093/jac/dkt236)
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MM: We commonly discuss gut bacteria and fungus but tend to ignore gut viruses unless we are referring to food poisoning or some other illness. We become painfully aware that this is an area that we need to learn more about and determine if we are able to take a pro-active position in maintaining viral gut health.
Proc Natl Acad Sci U S A 2013 Jul 8
The Human Gut Virome
Serial analyses of the gut viral population of a single human identified both persistent and rapidly evolving viral genomes.
Each gram of human stool contains >109 viruslike particles, most of which are still unidentified. To begin to understand the nature of this population, researchers in Philadelphia undertook a longitudinal analysis of the gut virome of a single individual.
The researchers analyzed 24 samples obtained from a healthy male at 16 time points over 2.5 years. Using deep metagenomic sequencing, they were able to identify 478 consensus DNA sequences, which appeared to correspond mostly to viral (bacteriophage) genomes. Approximately 13% of these consensus genomes were consistent with members of the Microviridae, Podoviridae, Myoviridae, and Siphoviridae, but the majority could not be classified. No eukaryotic cell viruses were definitively identified. On average, >80% of these consensus genomes were retained over the duration of the study. High genetic substitution rates (>1 substitution per 105 nucleotides per day) were noted for the Microviridae. Multiple mechanisms contributing to viral sequence variation were identified.
Comment: A full understanding of the human microbiome requires recognition of the diversity of our viral flora as well as of our bacterial and fungal flora. This work highlights the presence of a large viral gut population that is primarily composed of bacteriophages and certainly influences the stability and variability of the gut bacterial flora (NEJM JW Infect Dis Jun 25 2013). Of note: The RNA viral community was not examined in this study
Citation(s): Minot S et al. Rapid evolution of the human gut virome. Proc Natl Acad Sci U S A 2013 Jul 8; [e-pub ahead of print].
(http://dx.doi.org/10.1073/pnas.1300833110)
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Pertussis Vaccine Only 'Moderately Effective' During Outbreak
By Joe Elia
Tetanus toxoid, reduced diphtheria toxoid, and reduced acellular pertussis (Tdap) vaccines are only moderately effective against pertussis in adolescents and adults, according to a BMJ case-control study that includes data from the large California outbreak of 2010.
Researchers compared the vaccination status of some 670 cases (confirmed by polymerase chain reaction) against both 10,000 PCR-negative controls and 22,000 population-based matched controls. Vaccination coverage was 24% in the PCR-positive cases versus 32% among PCR-negative controls. The authors calculated a vaccine effectiveness of 53% using the PCR-negative controls, and 64% using the population controls.
Previous estimates of the vaccine's effectiveness were higher, but based on smaller sample sizes.
The authors suggest that giving the Tdap booster to those who received only acellular vaccines as children would be one strategy to decrease the incidence of pertussis. Their findings, they say, "draw attention to the need for more effective vaccines."
http://www.bmj.com/content/347/bmj.f4249
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