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Content 7


The Doctor and the Pharmacist Septembem 8, 2012

Radio Show Articles:
September 8, 2012

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Ginkgo Biloba: No-Go for Alzheimer's Prevention
West Nile Virus Cases Up 25% in Past Week
Declining Tobacco Use Among Middle and High School Students
Metabolic Syndrome in Kids Is Associated with Changes in Brain Structure, Cognition
U.S. Lags Behind Major European Countries in Preventing Deaths
Inhaled Glucocorticoids for Childhood Asthma Modestly Reduce Adult Height
Creatine Augmentation of SSRIs for Depression
Artificial Light at Night Provokes Depression
IOM: One Third of Healthcare Dollars Wasted
Insomnia and Depression: Chicken and Egg?
Restless Leg Syndrome Increases the Risk for Clinical Depression in Women
Infant Mice Get Fat When Exposed to Antibiotics
Nearly One Third of U.S. Adults Have Hypertension
Weight Loss for Overweight Cancer Patients: Benefits Aplenty
Wet Wrap ASAP
Does Spironolactone Raise Breast Cancer Risk?
K-V Loses FDA Lawsuit Over Makena
KV Cutting Price of Makena
Chinese Pharmaceutical Companies Using Gutter Oil in their Production Processes
Chinese Fake Sales Data on Phony Weight-Loss Product

MM: Although this study does not appear to be beneficial for AD, Ginkgo may still show some benefits to general memory and cognition. Remember that this product decreases clotting and may interact with some prescription drugs such as warfarin (Coumadin®), Heparin or Lovenox®. So if you choose to utilize Ginkgo, do so with caution.
Ginkgo Biloba: No-Go for Alzheimer's Prevention
Another large trial shows no benefit from ginkgo biloba extract in preventing Alzheimer disease, researchers report in the Lancet Neurology.
Nearly 2900 older adults without dementia who spontaneously reported memory complaints to their physicians were randomized to consume standardized ginkgo biloba extract or placebo for 5 years. Overall, the rate of diagnosis with probable Alzheimer's did not differ significantly between the ginkgo and placebo groups (1.2 and 1.4 cases per 100 person-years).
The authors note that a lower-than-expected Alzheimer's rate in both groups reduced the study's power, while a Lancet Neurology editorialist concludes: "For adults aged 70 years or older with a memory complaint who might be mildly cognitively impaired, use of [ginkgo biloba extract] does not decrease the risk of Alzheimer's disease over 5 years."
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MM: This is another example of why we should focus on strengthing our immune systems and one of the simplest ways to do this is to get simple exercise and add Vitamin C and D3 to our daily nutritional regimen. I recommend a typical dose of 5000IU of D3 and 3 Grams of Vitamin C for adults on a daily basis for those living anywhere north of Atlanta. Please contact Mark Drugs for more details and for your immune supportive supplements
West Nile Virus Cases Up 25% in Past Week
Nearly 2000 human cases of West Nile virus have been reported to the CDC so far this year, representing an increase of about 25% in the past week, the agency reports in its weekly update. Nearly 90 people have died from the disease in 2012.
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MM: We are finally seeing a positive trend to report. Unfortunately 1 out of 4 young people are still smoking and this figure does not include smokeless tobacco or pot nor does it address the frequency or amount used.
MMWR Morb Mortal Wkly Rep 2012 Aug 10; 61:581
Declining Tobacco Use Among Middle and High School Students
... but as many as 23% still report smoking.
The risks associated with tobacco use and second hand smoke are well known. Because the vast majority of adults who smoke started before age 18 years, efforts aimed at prevention of tobacco use in pediatric patients have long-term benefits. The CDC reviewed nationwide data for 18,866 students who completed a school-based, self-administered questionnaire every 2 years regarding current tobacco use (including traditional cigarettes, cigars, cigarillos, pipes, clove cigarettes [kreteks], and leaf-wrapped cigarettes [bidis]).
The most striking finding is a decrease in overall tobacco use from 15% in 2000 to 7% in 2011 among middle school students and from 34% to 23% among high school students. However, between 2009 and 2011, high school blacks reported increases in many types of tobacco use, including cigars and cigarettes (from 7% to 11%). The percentage of males who reported using cigars and smokeless tobacco was two to eight times that of females.
Comment: Despite the good news that tobacco use has decreased during the past decade in the pediatric population, as many as 23% still report some level of use. This study did not address frequency or quantity of use, so we don't know the percentage of tobacco users who smoke regularly or just tried tobacco recently. We need to continue our vigilance and support public health messages and enforcement of legal restrictions on the sale of tobacco products to youth. I often ask patients, "Do you smoke cigarettes or weed?" and don't usually incorporate other types of products. This report highlights that all tobacco products should be included in our screening questions.
Peggy Sue Weintrub, MD Published in Journal Watch Pediatrics and Adolescent Medicine September 5, 2012
Citation(s): Centers for Disease Control and Prevention (CDC). Current tobacco use among middle and high school students – United States, 2011.
MMWR Morb Mortal Wkly Rep
2012 Aug 10; 61:581.
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MM: Here we go back to the old adage, we are what we eat and unfortunately the historic, “good life” may not bode well for our young people.
Metabolic Syndrome in Kids Is Associated with Changes in Brain Structure, Cognition
Adolescents with metabolic syndrome have measurable differences in brain structure and cognitive function as compared with their peers, according to a Pediatrics study.
Forty-nine adolescents with abdominal obesity, reduced HDL, hypertriglyceridemia, hypertension, and insulin resistance (but not frank diabetes) were compared with 62 normal, age-matched controls. The subjects underwent cognitive studies and brain imaging.
Adolescents with metabolic syndrome scored significantly lower on standardized tests of arithmetic and spelling than did controls; in addition, they had smaller hippocampal volumes on brain imaging studies, as well as larger cerebrospinal fluid volumes.
The authors conclude: "Although obesity may not be enough to stir clinicians or even parents into action, these results among youth with [metabolic syndrome] strongly argue for an early and comprehensive intervention."
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U.S. Lags Behind Major European Countries in Preventing Deaths
Death rates from causes amenable to timely and effective healthcare (for example, diabetes and hypertension) are higher in the U.S. than in France, Germany, and the U.K., according to a Health Affairs study. The differences are striking among those under age 65.
Researchers examined death rates from so-called "amenable" diseases from 1999 to 2007. During that time, rates fell by 32% among U.K. women — but only by 18% among U.S. women (rate differences in men followed a similar pattern). The relative lack of U.S. progress was driven by rates of cerebrovascular disease and hypertension, especially among those under age 65 and thus not eligible for Medicare.
The authors cite regional variations in U.S. mortality rates, observing that Minnesota's rate is comparable to rates in some European countries — but is half those found in Mississippi and the District of Columbia.
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N Engl J Med 2012 Sep 3
Inhaled Glucocorticoids for Childhood Asthma Modestly Reduce Adult Height
Mean adult height was 1.2 cm lower in those who used budesonide during childhood.
Inhaled glucocorticoid therapy is an invaluable treatment for childhood asthma, but its use during the initial years is associated with reduced growth velocity in prepubertal children. To determine the long-term effect researchers measured final adult height in 943 asthmatic patients who had been randomized to receive budesonide (400 µg/day), the mast cell stabilizer nedocromil (16 mg/day), or placebo for 4 to 6 years beginning at age 5 to 13 years. All children received albuterol.
Adult height was measured at a mean age of 25 years. Compared with mean adult height in the placebo group, mean height was significantly lower (1.2 cm lower) in the budesonide group, but not in the nedocromil group (0.2 cm lower). The effect of budesonide on adult height did not vary significantly by sex, age at trial entry, race, or duration of asthma at trial entry. A greater daily dose was associated with lower adult height. Reduction in growth and growth velocity with budesonide occurred during the first 2 years of therapy, primarily in prepubertal children, but did not progress thereafter.
Comment: Budesonide therapy reduces adult height when given to prepubertal children with asthma. The reduction is modest; however, parents should be informed of this effect so they can weigh the risks and benefits of inhaled glucocorticoids. Nonetheless, they remain an important therapy for chronic childhood asthma.
F. Bruder Stapleton, MD Published in Journal Watch Pediatrics and Adolescent Medicine September 4, 2012
Citation(s): Kelly HW et al. Effect of inhaled glucocorticoids in childhood on adult height.
N Engl J Med 2012 Sep 3; [Epub ahead of print].
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MM: Simple protein and amino acids, the building blocks of muscle and other metabolic and neurological function, added to our diets may show a significant effect on depression and possibly on other brain chemistry as well.
Am J Psychiatry 2012 Aug 1
Creatine Augmentation of SSRIs for Depression
In depressed women, adding creatine to an SSRI seems to enhance the medication's antidepressant effects.
The dietary supplement creatine has been widely promoted for use in building muscles and boosting energy, and Americans use more than 4 million kg of creatine annually. Prior research has suggested that improvements in depressive symptoms and response to antidepressants are linked to greater efficiency in brain energetics and that increased levels of brain phosphocreatine might facilitate the production of the high-energy molecule ATP. In preclinical research, creatine has shown antidepressant-like effects in female (but not male) rats. Based on these findings, investigators in Korea and Utah conducted a foundation- and government-supported, 8-week, randomized, controlled trial in which 52 otherwise medically healthy women with major depression received escitalopram (overall mean dose, 15 mg/day) plus either creatine (5 g/day) or placebo.
The groups had statistically similar rates of concomitant lorazepam and zolpidem use. Patients receiving creatine supplementation showed greater improvement than placebo recipients on the Hamilton Rating Scale for Depression (HRSD) starting by week 2; a higher response rate (≥50% reduction in HRSD scores) at weeks 2 and 4, but not later; and a higher week-8 remission rate (HRSD score, ≤7; 52% vs. 26%). Adverse events were reported by similar numbers of patients in the creatine and placebo groups.
Comment: It is unclear why only female rats showed improvement with creatine. Still, these provocative results merit extension in men and women. Creatine is to be avoided in patients with renal disease, hepatic disease, or hypertension, and it is associated with manic/hypomanic switches in depressed bipolar patients. Still, if other studies confirm the benefits, this easily available and popular supplement might prove to be a worthwhile augmentation strategy for depression — at least for women.
Joel Yager, MD Published in Journal Watch Psychiatry August 20, 2012
Citation(s): Lyoo IK et al. A randomized, double-blind placebo-controlled trial of oral creatine monohydrate augmentation for enhanced response to a selective serotonin reuptake inhibitor in women with major depressive disorder. Am J Psychiatry 2012 Aug 1; [e-pub ahead of print].
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MM: Bright light at night may decrease melatonin production and that can contribute to sleep disturbances as well as immune function disturbances. Bright light therapy may be used productively in the morning or evening to have an effect on circadian rhythm and correct sleep disturbances. Light as a tool can be productive or destructive. That is why it is important to work with a knowledgeable practitioner when it comes to alternative treatments. Your pharmacist at Mark Drugs can help to guide you or help you find an expert who can assist you in finding your optimal treatment approach(es).
Mol Psychiatry 2012 Jul 24
Artificial Light at Night Provokes Depression
In an animal study, artificial light produces depression-like behavioral and neurobiological features that are reversed by an antagonist of tumor necrosis factor.
The increase in prevalence of depression in the later decades of the 20th century suggests a role for recent environmental changes. Chronic exposure to artificial light at night is one possible factor. In this study, hamsters were exposed to nighttime darkness or dim artificial light.
Nighttime artificial light was associated with depression-like behaviors, lower hippocampal expression of the brain-derived neurotrophic factor gene, lower dendritic spine density, and enhanced gene expression of tumor necrosis factor α (TNF-α). These changes were reversed within 2 weeks of removing light exposure. Changes in behavior (but not in dendritic spine density) were also reversed by intracerebral injection of a TNF antagonist (supplied by the manufacturer).
Comment: Nocturnal light suppresses melatonin, a hormone known to prevent the development of depression in animals, whereas inflammatory cytokines such as tumor necrosis factor provoke depression. Might exposure to nocturnal artificial light promote depression in some of our patients and even inhibit recovery from depression? Would patients who stay up late, into the early hours of the morning, and then sleep late, into the early afternoon (thus reducing their exposure to natural morning light), be especially vulnerable to this effect? Would falling asleep in front of a television set have a similar effect? Promoting earlier bedtimes and minimizing nocturnal light exposure would be an easy intervention to suggest to some patients for preventing recurrence of depression and, perhaps, even facilitating recovery.
Peter Roy-Byrne, MD Published in Journal Watch Psychiatry August 6, 2012
Citation(s): Bedrosian TA et al. Chronic dim light at night provokes reversible depression-like phenotype: Possible role for TNF. Mol Psychiatry 2012 Jul 24; [e-pub ahead of print].
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IOM: One Third of Healthcare Dollars Wasted
Roughly one third of the money spent on U.S. healthcare in 2009 — about $750 billion — didn't improve patients' health, according to an Institute of Medicine report released Thursday.
The report, Best Care at Lower Cost: The Path to Continuously Learning Health Care in America, outlined six categories of waste — unnecessary services, inefficient delivery of care, unnecessary administrative costs, inflated prices, missed opportunities for prevention, and fraud.
Among the group's recommendations to help improve care while reducing cost:

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Psychosom Med 2012 Aug 9
Insomnia and Depression: Chicken and Egg?
A prospective study shows that each can lead to the other.
Insomnia and depression are closely associated, but exactly how they might be causally linked is uncertain. These investigators used prospective data on 24,715 individuals (mean age at baseline, 45) from two waves of a Norwegian health survey; the waves were conducted 11 years apart.
Analyses were conducted on two groups — individuals who were initially clinically depressed without concurrent insomnia, and individuals initially experiencing insomnia without concurrent clinical depression. In the initial-depression group, those who were also depressed at the next wave were at significantly greater risk for developing insomnia, even after adjustment for demographics, somatic symptoms, lifestyle factors, and anxiety (adjusted odds ratio, 4.34). Patients whose depression did not exist at the next wave were still at significantly increased risk for later insomnia (AOR, 1.72). Those with initial insomnia who also had insomnia at the next wave were at significantly greater risk of developing clinical depression (AOR, 4.35).
Comment: These results suggest that insomnia and depression are associated bidirectionally; each substantially predicts the risk for the other. Individuals entering depression are known to often develop concurrent insomnia, and previous studies have shown that individuals with insomnia are at risk for developing depression. Some of these bidirectional connections clearly involve associations of insomnia and depression with co-occurring anxiety states, other psychiatric or general medical comorbidities, or substance-related factors. Despite these complicating factors — and even when they are absent (by some as yet unelucidated mechanism) — primary insomnia appears to predispose to clinical depression. Clinicians seeing patients with primary insomnia and emerging clinical depression should be aware that early successful treatment of the insomnia may prevent the subsequent development of the depression.
Joel Yager, MD Published in Journal Watch Psychiatry August 30, 2012
Citation(s): Sivertsen B et al. The bidirectional association between depression and insomnia: The HUNT study. Psychosom Med 2012 Aug 9; [e-pub ahead of print].
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Am J Epidemiol 2012 Aug 15; 176:279.
Restless Leg Syndrome Increases the Risk for Clinical Depression in Women
A 6-year prospective study clarifies the links between the two disorders.
Restless leg syndrome (RLS), present in 6.4% to 11.2% of American women, has been associated with clinical depression, antidepressant medications, and Parkinson disease, all presumably related via hypodopaminergic mechanisms. However, whether RLS results from or antedates depression, antidepressants, or parkinsonism has been unsettled. In this first-ever prospective, population-based study, researchers analyzed 6 years of data on RLS in 56,399 women (mean age, 68) enrolled in the Nurses' Health Study. The women were free of depression and not taking antidepressants.
A total of 928 women reported that they had been diagnosed with RLS. Compared to those without the diagnosis, these women were significantly more likely to be older, to report frequent snoring, and to have more co-occurring medical conditions, such as cardiovascular and metabolic conditions and Parkinson disease.
At follow-up, 1268 cases of incident depression were found. After adjustment for pertinent covariates (including sleep duration) and preexisting conditions, the relative risk for clinical depression was significantly higher among those with baseline RLS (RR, 1.5). In RLS patients who did not manifest frank clinical depression, the risk for elevated depressive symptoms at follow-up was similarly increased.
Comment: Identification of restless leg syndrome in this population relied on diagnoses by participants' physicians, and the prevalence was considerably less than that reported in other studies, likely pointing to underdiagnosis of the syndrome in the community. At the same time, the risk for RLS-associated depression was lower than that reported in cross-sectional studies. Insomnia is also linked to depression (JW Psychiatry Aug 30 2012). Better understanding of the mechanisms by which RLS leads to depression may help clinicians preventively intervene to reduce the risk for subsequent clinical depression in these patients.
Joel Yager, MD Published in Journal Watch Psychiatry August 30, 2012
Citation(s): Li Y et al. Prospective study of restless legs syndrome and risk of depression in women. Am J Epidemiol 2012 Aug 15; 176:279.
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Nature 2012 Aug 30; 488:621.
Infant Mice Get Fat When Exposed to Antibiotics
Are there implications for the childhood obesity epidemic?
People in the agriculture industry have long recognized that giving subtherapeutic doses of antibiotics to livestock promotes body growth in these animals. To better understand the mechanism underlying that effect, researchers studied how subtherapeutic antibiotic therapy (STAT) affects the gut microbiome and body composition of mice.
At weaning, mice were exposed, through their drinking water, to one of four STAT regimens (penicillin, vancomycin, penicillin plus vancomycin, or chlortetracycline) or to no antibiotics. At 7 weeks, overall body weight did not differ among the groups, but the STAT groups had significantly greater total body fatand gradually developed even more fat through 26 weeks. Compared with the no-STAT group, the STAT groups also experienced significantly greater increases in bone-mineral density and in levels of glucose-dependent insulinotropic polypeptide, a hormone produced in small-intestine K cells that has been found to be elevated in mouse models of obesity.
STAT did not yield an overall change in the microbial census but did alter the taxonomic composition of the gut microbiome — specifically, copies of prokaryotic genes involved in synthesizing short-chain fatty acids (SCFAs) were increased. That increase was associated with increases in colonic SCFA concentrations and in how many calories the mice extracted from their food.
Comment: This work in mice sheds light on the mechanism by which subtherapeutic antibiotic regimens fatten livestock. More important, the findings raise the question of whether antibiotic use could have similar effects in children and thereby contribute to the obesity epidemic in industrialized countries.
Richard T. Ellison III, MD Published in Journal Watch Infectious Diseases September 5, 2012
Citation(s): Cho I et al. Antibiotics in early life alter the murine colonic microbiome and adiposity. Nature 2012 Aug 30; 488:621.
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Nearly One Third of U.S. Adults Have Hypertension
An estimated 30% of U.S. adults — roughly 67 million Americans — are hypertensive, according to a study published in MMWR. The analysis was based on NHANES surveys from 2003 to 2010 and included more than 20,000 individuals aged 18 and older.
Among the other findings:

MMWR's editors call attention to the "potential missed opportunities by individuals, health-care providers, and health-care systems to improve hypertension control."
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J Clin Oncol 2012 Jul 1; 30:2354
Weight Loss for Overweight Cancer Patients: Benefits Aplenty
Diet and exercise interventions resulted in better maintenance of functional status and reductions in levels of hormones associated with postmenopausal breast cancer.
Obesity has many detrimental health implications, including excess risk for postmenopausal breast cancer and functional decline in cancer survivors. Lifestyle interventions with diet and exercise to reduce weight have been shown to lower risk for cancer and cancer recurrence and to decrease functional decline in older cancer survivors. However, the reproducibility, durability, and real-life adoption of such interventions have been questioned. Two studies address these concerns.
In the initial Reach Out to Enhance Wellness (RENEW) study, investigators assessed the effectiveness of a diet and exercise intervention in 641 sedentary, overweight patients (age, >65; body mass index, 25–40) who were long-term (≥5-year) survivors of breast, prostate, or colorectal cancer (JAMA 2009; 301:1883). They found that those who participated in the 1-year telephone-based intervention achieved favorable changes in physical activity and dietary behaviors, modest weight loss, and less decline in functional status compared with wait-listed controls.
Now, the RENEW investigators update results for the original participants at 2 years (1 year after intervention ended) and report outcomes for controls who participated in the intervention for 1 year after a 1-year delay. In the original intervention group, no significant relapse in diet quality, body-mass index (BMI), or physical activity occurred, although an increase in functional decline was noted. In the delayed-intervention group, improvements in all endpoints were observed, similar to those achieved by the original intervention group. These data speak to the durability of this intervention and the ability of participants to adopt these lifestyle changes after the intervention ends.
In the Nutrition and Exercise for Women (NEW) trial, researchers evaluated the effect of diet and exercise interventions on 439 sedentary, overweight, postmenopausal women (mean age, 58; mean BMI, 30.9). Patients were randomized to a reduced-calorie diet, moderate to vigorous aerobic exercise, combined diet and exercise, or no diet or exercise intervention (controls). The objective was to determine whether the interventions could modify sex hormones that are linked to the risk for developing postmenopausal breast cancer.
Weight loss achieved by a reduced-calorie diet with or without exercise produced significant reductions in serum concentrations of estrone (the primary endpoint), estradiol, free estradiol, and free testosterone, while increasing sex hormone–binding globulin concentrations. Androstenedione concentrations were similar among patients in the intervention groups and controls.
Comment: These reports suggest that older, obese patients with or without cancer who focus on weight loss in a sustainable way can reap many benefits, including maintenance of functional status (a surrogate for independence) and reduction in levels of hormones that have been implicated in the development of postmenopausal breast cancer.
William J. Gradishar, MD Published in Journal Watch Oncology and Hematology August 7, 2012
Citation(s): Demark-Wahnefried W et al. Reach out to enhance wellness home-based diet-exercise intervention promotes reproducible and sustainable long-term improvements in health behaviors, body weight, and physical functioning in older, overweight/obese cancer survivors. J Clin Oncol 2012 Jul 1; 30:2354.
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J Am Acad Dermatol 2012 Jul; 67:100
Wet Wrap ASAP
An underused, intensive topical treatment is effective for severe atopic dermatitis.
Wet dressings placed over topical steroids work well to reestablish control in patients with widespread eczemas, such as atopic erythrodermas. Messy and time-consuming, such treatment has lost favor with dermatologists and with patients. This is unfortunate.
A recent retrospective analysis reviewed the cases of 218 patients with atopic dermatitis (age, <18 years) hospitalized at Mayo Clinic (Rochester, Minnesota) over a 30-year period. Closed, nonoccluded, wet dressings were applied over topical corticosteroid creams applied twice daily. Dressings remained in place about 3 hours, with a 30- to 45-minute interval between changes. The topical corticosteroid creams were triamcinolone 0.025% (3% of patients), 0.05% (27%), or 0.1% (24%) cream, or hydrocortisone 1% (7%) or 2.5% (39%) cream. The regimen was as follows: (1) daily tub bath, (2) application of topical steroid creams, (3) application of wet dressing, usually soaked with warm tap water but occasionally with dilute aqueous solutions of acetic acid, (4) application of cotton flannel clothing over the wet dressings to help retain moisture, and (5) placement of warm blankets for patient comfort. Antibiotics were given to 72% of patients for skin or other infections.
Mean duration of hospitalization was 3.61 days. All patients improved, and about 80% had moderate or marked improvement.
Comment: When hospitalization was more common, I hospitalized many children with atopic dermatitis for this sort of treatment, but I nearly always used 1% hydrocortisone as my steroid. The predictable, rapid, and dramatic response proved to the parents, children, and me that plain old 1% hydrocortisone cream was a very useful topical drug when used under wet compresses. This cream is effective, relatively safe, and inexpensive. Treatments never seemed to work as well at home, but many parents relied on hydrocortisone cream and wet compress treatments at least overnight. The combination therapy improved dermatitis and reduced itching and sleepless nights. For home, I recommended wet sweat shirts and wet sweat pants as dressings to keep the skin wet, and plastic mattress pads to keep the mattress dry.
— Mark V. Dahl, MD Published in Journal Watch Dermatology September 7, 2012
Citation(s): Dabade TS et al. Wet dressing therapy in conjunction with topical corticosteroids is effective for rapid control of severe pediatric atopic dermatitis: Experience with 218 patients over 30 years at Mayo Clinic. J Am Acad Dermatol 2012 Jul; 67:100.
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BMJ 2012 Jul 13; 345:e4447
Does Spironolactone Raise Breast Cancer Risk?
In a large cohort study, risk was not higher in women who used this drug.
Because gynecomastia is a common adverse effect of the aldosterone antagonist spironolactone, some clinicians avoid prescribing this drug to women out of concern that exposure might raise risk for breast cancer. U.K. investigators conducted a retrospective cohort study that involved 1.3 million women without histories of breast cancer to determine whether exposure to spironolactone was associated with excess risk for breast cancer. The exposed cohort consisted of 28,000 older women (age, >55) who received ≥2 prescriptions for spironolactone (half received ≥12 prescriptions). Exposed patients were matched by age and socioeconomic status to nearly 56,000 unexposed controls.
After a mean follow-up of 4 years, both the exposed and unexposed cohorts had unadjusted breast cancer annual incidence rates of 0.4%. Both adjustment for risk factors and subgroup analyses confirmed no excess risk for breast cancer.
Comment: The finding that exposure to spironolactone does not raise risk for breast cancer in women older than 55 is welcome, given that women who are prescribed spironolactone (most commonly for hypertension and heart failure) tend to be older — and advancing age itself is a risk factor for breast cancer.
Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine August 9, 2012
Citation(s): Mackenzie IS et al. Spironolactone and risk of incident breast cancer in women older than 55 years: Retrospective, matched cohort study. BMJ 2012 Jul 13; 345:e4447.
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K-V Loses FDA Lawsuit Over Makena
K-V's lawsuit alleging that the FDA was allowing "unlawful competition" involving its Makena product was dismissed by a federal judge. The judge threw out the company's claims that the FDA caused it "irreparable harm" by refusing to block pharmacies that created a cheaper alternative of the drug used to reduce the risk of pre-term birth in women. "This case is fundamentally an effort to get the court to direct and oversee the FDA's enforcement activities, and that it cannot do," the judge said in the 38-page ruling.
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KV Cutting Price of Makena
From $1500 per injection to $300…what a drop! KV's price on Hydroxyprogesterone Caproate Injection is again a news item. As a result of the outlandish price compared to the identical compounded version, KV is trying to woo states into placing their product on their state programs and sneaking in statements that only the FDA-approved product should be paid for; even at a higher price than the compounded versions of $20 per injection.
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Chinese Pharmaceutical Companies Using Gutter Oil in their Production Processes
Chinese authorities have stepped up measures against gutter oil upon finding that more pharmaceutical firms have used gutter oil, a waste material, to replace soy oil in their production processes. The companies stood trial for processing and selling gutter oil (also known as swill oil), oil ladled from drains near restaurants. The State FDA told the country's pharmaceutical firms to carefully scrutinize their sources to prevent such ingredients being used in medicine.
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Chinese Fake Sales Data on Phony Weight-Loss Product
China Sky One Medical Inc. and its top executives have been sued by the U.S. Securities and Exchange Commission over claims they inflated revenue by about $20 million with fake sales of a weight-loss product, the "Slim Patch." The agency's suit against China Sky is the latest in a series of regulatory actions targeting financial statements from Chinese companies listed on U.S. exchanges; several companies have been delisted.

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