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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 9, 2014

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Doctor with Ebola returns to U.S. for Care
CDC: Avoid Travel to Ebola-Affected Countries
Nonsurgical Interventions Prevent Gallstones During Weight Loss
Adolescent BMI Linked to All-Cause Mortality by Age 50
Drug Companies Oppose Off-label Medicine Reimbursement When it Affects Their Sales
Small-Bowel Mucosal Damage with Low-Dose Aspirin Therapy
FDA Approves New Treatment for Toenail Fungal Infection
Hair Loss Is Linked to the Antifungal Voriconazole
Hemorrhoids and Anal Fissures During and After Pregnancy
Averting Gestational Hypertension
Sleep-Related Infant Deaths: Risk Factors Vary for Younger and Older Babies
Single-Question Screening Can Help Identify Teens with Substance Misuse

MM: We have had numerous calls and questions regarding the transfer of infected healthcare workers who have been returned to the U.S. This article and the CDC reference are here for informational details only.
Doctor with Ebola returns to U.S. for Care
By Kelly Young, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
An American physician who contracted the Ebola virus while working in West Africa was transferred to Emory University Hospital in Atlanta over the weekend.
He is being cared for in the hospital's isolation unit for infectious diseases, which was built to treat CDC doctors who became ill. A second infected aid worker is expected to arrive within days.
Meanwhile, the CDC issued a health advisory giving physicians advice regarding whom to suspect of having Ebola virus disease, how to obtain and submit specimens for diagnostic testing, and how to best control infection in a hospital setting.
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MM: The CDC statements below should help to alleviate the fears of those who worry about a possible domestic Ebola epidemic. Although we have grown to distrust many statements made by government agencies and politicians due to seeming ulterior motives, we can only pray that these are valid.
CDC: Avoid Travel to Ebola-Affected Countries
By Kelly Young           
Edited by William E. Chavey, MD, MS
The CDC is recommending that people avoid non-essential travel to Sierra Leone, Guinea, and Liberia given the worsening Ebola outbreak. The level 3 advisory does not affect people traveling for humanitarian purposes.
The World Health Organization says over 1300 people have been infected with Ebola in Africa, and more than 700 have died.
The CDC is sending 50 additional disease control specialists to the region. CDC Director Thomas Frieden says that in a best-case scenario, it would take at least 3 to 6 months to control the outbreak, but there are challenges with the existing healthcare infrastructure and violence against healthcare workers.
The CDC is helping countries to screen airline passengers for illness before they leave Africa. If Ebola arrived in the U.S., Frieden said, any U.S. hospital with an intensive care unit would be able to sufficiently isolate patients. There is no "potential of Ebola spreading widely in the U.S.," he said. "That is not in the cards."
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MM: For those obese patients with either a history of gall stones or a family predisposition to developing them and who determine to go on an aggressive weight loss program, whether HCG or gastric/bariatric surgery, then it is a good idea to consider using ursodeoxycholic acid (Ursodiol) as an adjunctive medication. This is a plan that bariatric surgeons should probably incorporate into their SOP's for at risk patients.
Clin Gastroenterol Hepatol 2014 Jul; 12:1090
Nonsurgical Interventions Prevent Gallstones During Weight Loss
Ursodeoxycholic acid and high-fat weight-loss diets reduced risk for gallstone formation in a meta-analysis.
Rapid weight loss is associated with an increased risk for gallstone formation because of cholesterol supersaturation and gallbladder hypomotility. To evaluate the efficacy of nonsurgical treatments to prevent gallstones in obese adults participating in weight loss interventions, investigators conducted a systematic review and meta-analysis.
Thirteen randomized, controlled trials were included in the study and comprised 1836 participants who were obese (body-mass index >30 kg/m2). Eight trials involved dietary weight-loss interventions, and five involved bariatric surgery. Eleven trials assessed administration of ursodeoxycholic acid (UDCA) during diet-based interventions or after bariatric surgery, and two trials assessed a high-fat weight-loss diet compared with a low-fat weight-loss diet. Meta-analyses were performed using random-effects models. Heterogeneity testing and sensitivity analysis were performed.
High-fat weight-loss diets reduced the risk for ultrasound-verified gallstones compared with low-fat weight-loss diets (risk ratio, 0.09; 95% confidence interval, 0.01–0.61). UDCA administration also reduced the risk for gallstone formation compared with controls, both in trials of dietary interventions (RR, 0.17; 95% CI, 0.11–0.25) and in trials involving bariatric surgery (RR, 0.42; 95% CI, 0.21–0.83). UDCA reduced the risk for cholecystectomy for symptomatic gallstones (RR, 0.20; 95% CI, 0.07–0.53).
Comment: This meta-analysis suggests that UDCA and high-fat weight-loss diets decrease the overall risk for gallstone formation during weight loss and that UDCA administration reduces the risk for symptomatic gallstones. Future studies should explore clinical and genetic factors that identify patients at the highest risk for gallstones and help introduce these preventative interventions into clinical practice.
Citation(s): Stokes CS et al. Ursodeoxycholic acid and diets higher in fat prevent gallbladder stones during weight loss: A meta-analysis of randomized controlled trials. Clin Gastroenterol Hepatol 2014 Jul; 12:1090.

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MM: The old saying that, "...you can't be too rich or too thin." may not be true at all. The data seems to trend towards a detrimental state for those who are too thin and those who are too fat. Historically, the wealthy were those who tended to suffer from conditions associated with excess such as gout or diabetes associated with obesity. Today the trend is for those conditions to prevail across American society. Moderation in either direction should be the appropriate path to take and hopefully we will see that societal trend as our population becomes increasingly aware of the dangers of our indulgences.
J Clin Endocrinol Metab 2014 Jun; 99:209
Adolescent BMI Linked to All-Cause Mortality by Age 50
Adults who were overweight or obese as adolescents did not experience the gains in life expectancy that those with normal adolescent weight achieved during the past 4 decades.
Obesity prior to adulthood is linked with increased risk for death in middle-aged and elderly individuals, but whether this association holds true for those younger than age 50 is not known. Investigators analyzed body-mass index (BMI) and socioeconomic information collected from more than 2 million Israeli adolescents (aged 16–20; born 1950–1993; 59% male) during evaluations for compulsory military service and compared it with subsequent data on all-cause mortality prior to age 50. Individuals with preexisting medical conditions and those who died from military trauma were excluded.
Approximately 15,000 men and 3000 women died during follow-up (mean ages at death, 36 and 35, respectively). Among both sexes, higher and lower BMIs (especially >97th percentile and <3rd percentile) were associated with increased mortality before age 50. Among men, multivariate analyses accounting for birth year, age, education, and socioeconomic status revealed that BMI was significantly associated with all-cause mortality beginning at 50th percentile BMI (hazard ratio at 50th–75th percentile, 1.05) and peaking at ≥97th percentile BMI (HR, 1.90). Parallel analyses for women revealed a similar trend, but beginning at ≥85th percentile BMI (HR for 85th–90th percentile, 1.33) and peaking at ≥97th percentile BMI (HR, 2.16). Adults of normal weight during adolescence experienced a decrease in mortality HR in each successive 10-year birth cohort from 1950 to 1980; this trend was not observed for adults who were overweight or obese as adolescents.
Comment: If these data can be applied to the U.S. population, we won't need to wait 40 or 50 years to see a spike in deaths attributable to increases in adolescent obesity rates. Whether becoming normal weight in the third decade of life can ameliorate this risk is unknown. That the increased risk for death before age 50 is observed even among men whose BMI during adolescence was in the 50th to 75th percentile range is particularly troubling and merits further study
Citation(s): Twig G et al. Adolescence BMI and trends in adult mortality: A study of 2.16 million adolescents. J Clin Endocrinol Metab 2014 Jun; 99:2095.

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MM: Drug companies and big business in general has never been known to express opinions that work to their financial detriment. In fact, it has not been unusual to see fiscal/operational policies that may be contradictory in their stated social positions. For many years drug companies have been prohibited from directly promoting the off label use of their products by the FDA. The FDA requires extensive testing and clinical studies to obtain added indications for products. These can be strategically be released in order to extend patents and increase company profits for drugs that would otherwise be scheduled for generic release. The biologicals, such as Avastin or Lucentis, are another story altogether. Savvy scientists and clinicians who have read the research published by the drug companies and projected alternative uses for these drugs and then successfully tested them in their patients have led the way for these same drug companies to make minor changes in these biologicals that would lend the same or similar results thereby establishing newer entities that are many times more expensive. This has been the case and is affecting payors worldwide. You can't have it both ways. Either you take care of patients and treat them in the best way possible as has been done for thousands of years or you fall prey to corporate greed and let society and the general population underwrite these obscene corporate profits. I have nothing against corporate profit but I do object to corporate gouging.
Drug Companies Oppose Off-label Medicine Reimbursement
When it Affects Their Sales

Pharmaceutical companies are "pushing back" against decisions by European governments to reimburse patients for drugs being used "off-label," specifically involving Avastin and Lucentis. Paying for off-label drugs, which are often cheaper than their approved rivals, is necessary to cut national healthcare bills. Avastin typically sells for about €40 ($53.90) per injection in Europe, while Lucentis sells for around €900 ($1212.75) per injection.
Pharmaceutical companies argue that encouraging doctors to prescribe medicines beyond their approved usage could harm patients and may violate European Union law. Prescribing medications off-label is neither illegal nor uncommon in Europe.
Roche said it is "our obligation to inform the medical community including physicians and patients about the known risks associated with the off-label uses of our medicines."
Italian antitrust authorities ruled that Roche and Novartis were colluding to push doctors to prescribe Lucentis rather than Avastin and decided to seek €1.2 billion in damages from the two companies. The companies presented Avastin as riskier than Lucentis to increase prescriptions for the more expensive approved drug.
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MM: It almost seems contradictory that the use of PPI's with NSAID's or low dose aspirin would increase lesions as these same products have been used to both treat and theoretically to prevent them. This shows us that the thought process of decreasing gastric acid to treat small intestine ulcers is flawed. Although these medications relieve immediate gastric distress, they appear to create long term problems.
Gastrointest Endosc 2014 May 13
Small-Bowel Mucosal Damage with Low-Dose Aspirin Therapy
Concomitant proton-pump inhibitor use doubled the risk for mucosal lesions.
Low-dose aspirin (75–325 mg per day) is associated with small-intestine damage. To assess the magnitude of this effect and associated risk factors, investigators in Japan prospectively collected data from 205 patients taking low-dose aspirin who were referred to one of five hospitals for video capsule endoscopy (VCE). All patients had previous negative upper gastrointestinal endoscopy and colonoscopy prior to entry into the study.
Of 198 patients included in the final analysis, 114 (57.6%) had at least one mucosal lesion detected by VCE. In multivariate analysis, only the use of proton-pump inhibitors (PPIs) and use of enteric-coated aspirin were associated with increased risk for mucosal lesions (odds ratios, 2.04 and 4.05, respectively).The authors conclude that PPI use increases the risk for mucosal breaks in the setting of low-dose aspirin therapy.
Comment: Other studies have demonstrated that PPI use increases the severity of small-bowel enteropathy, possibly because of increased bacterial colonization. The use of VCE to quantitate small-bowel enteropathy induced by aspirin or nonsteroidal anti-inflammatory drugs likely underestimates the scope of the problem. Increased mucosal permeability is a common effect of these drugs and may occur in the absence of visible mucosal lesions
Citation(s): Endo H et al. Risk factors for small-bowel mucosal breaks in chronic low-dose aspirin users: Data from a prospective multicenter capsule endoscopy registry. Gastrointest Endosc 2014 May 13; [e-pub ahead of print].
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MM: It's interesting that a product with only a 7-9% success rate could get FDA approval. Mark Drugs has been compounding topical toenail paint/drop of Itraconazole 2% combined with Ibuprofen in DMSO for many years and we see better than a 75% success ratio of our patients with toenail fungus. Just to make it more impressive, we see complete cures in as little as six months! For more information about this and other compounded options that are economical and have clinical effectiveness, please contact the staff at Mark Drugs.
FDA Approves New Treatment for Toenail Fungal Infection
By Kelly Young Edited by David G. Fairchild, MD, MPH, and Richard Saitz, MD, MPH, FACP, FASAM
The FDA has approved tavaborole topical solution, 5% (Kerydin) to treat onychomycosis of the toenails, the manufacturer announced Tuesday.
The solution is applied with a dropper to the affected toenails once daily for 48 weeks. In two trials of nearly 1200 people with onychomycosis without dermatophytomas or lunula involvement, 7-9% of those treated with tavaborole achieved "complete cure" at 52 weeks, compared with 0.5-1.5% of patients given topical placebo. Side effects included exfoliation, ingrown toenail, erythema, and dermatitis.
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MM: Hyper-resistant fungal infections have become a much greater problem in the past 20 years as we have developed stronger and stronger medications to battle these opportunistic infections. Much of this developed with the inappropriate overuse of antibiotics that allowed these fungi to thrive without other microorganism competitive inhibition. The good news relative to the transient alopecia that seems to accompany voriconazole is that there is hair re-growth upon cessation of the drug.
Clin Infect Dis 2014 Aug 1; 59:e61
Hair Loss Is Linked to the Antifungal Voriconazole
Most patients who were treated for ≥1 month reported alopecia and nail changes — some severe
The 2012 outbreak of fungal infections associated with injections of contaminated methylprednisolone affected about 750 patients, most of whom developed meningitis, paraspinal abscesses, or both. These infections were caused mostly by the rare mold Exserohilum rostratum, and treatment involved high doses of the antifungal voriconazole. Physicians at a hospital in Michigan heard complaints so frequently about thinning hair and nails from patients with these infections that they devised and administered a formal questionnaire.
Among 152 patients who had received voriconazole for ≥1 month, 125 (82%) reported alopecia, most commonly on the scalp, arms and legs, and eyebrows or eyelashes; loss of facial, axillary, chest, and pubic hair also was noted. Nail changes were reported by 106 patients (70%), including nail loss by 15 (10%). Neither voriconazole dose nor serum levels during therapy predicted hair loss. In almost all patients, hair loss had stopped and regrowth had begun by 3 months after stopping the drug.
Comment: This report is interesting, primarily because alopecia occurred in fewer than 2% of voriconazole recipients in premarketing trials, and has not been reported in postmarketing surveillance. The authors wonder if the high drug exposure in these patients might have been responsible, or if — because the drug is used so often in patients with hematological malignancies who are receiving chemotherapy — alopecia might simply have been ascribed to other drugs in the past. In either case, clinicians should counsel voriconazole-treated patients about this possible side effect.
Citation(s): Malani AN et al. Alopecia and nail changes associated with voriconazole therapy. Clin Infect Dis 2014 Aug 1; 59:e61.

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MM: It's great to provide advice to prevent hemorrhoids or anal fissures such as "eat more fiber", "take a stool softener", "don't strain when having BM's" but what about if a patient has done all these precautionary activities and still develops the problem? Mark Drugs has been preparing prescriptions that have addressed these problems for more than a decade. Gastroenterologists at Universities and hospitals throughout the Chicagoland area have been referring their patients to us for medications that reduce the swelling and pain and will in many cases cure the anal fissure! Please contact the Mark Drugs team for more information and to determine if this product is appropriate for you or a person that you are close to.
BJOG 2014 May 9
Hemorrhoids and Anal Fissures During and After Pregnancy
Risk factors for perianal symptoms included constipation during pregnancy and prolonged straining during labor
Perianal symptoms, including hemorrhoids, anal fissures, discharge, bleeding, and pain, are common among women who have recently given birth. In a prospective observational cohort study to assess incidence of and risk factors for perianal disease in pregnancy, investigators in Lithuania examined 280 pregnant women (44% pregnant for the first time, 56% repeated pregnancies) at a university hospital and outpatient clinics during the first and third trimesters, immediately after delivery, and 1 month postpartum.
In all, 44% of participants developed perianal symptoms; of these women, 93% had hemorrhoids and 6% had hemorrhoids and anal fissures. More than half of the women with hemorrhoids had thrombosed hemorrhoids. The mean weight of newborns was 3545 g. Mean duration of straining or bearing down in labor was 13.4 minutes (range, 3–50 minutes), 20% of women had histories of perianal disease, and most perianal symptoms (61%) developed during the third trimester. Independent risk factors for perianal symptoms included constipation during pregnancy, personal history of perianal disease, newborn birth weight >3800 g, and straining duration >20 minutes during labor.
Comment:The majority of perianal symptoms emerged during the third trimester, and constipation was the only significant preventable risk factor; thus, prophylactic interventions for constipation (e.g., encouraging exercise and consumption of fiber and fluids) are best begun well before the third trimester. Given that prolonged straining or bearing down also was a significant risk factor, improved methods of avoiding difficult labor (e.g., encouraging passive fetal descent) could also help reduce the incidence of pregnancy-associated perianal symptoms.
Citation(s): Poskus T et al. Haemorrhoids and anal fissures during pregnancy and after childbirth: A prospective cohort study. BJOG 2014 May 9; [e-pub ahead of print].
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MM:Physiologic demands of the body during pregnancy are unique and quite different from the demands during the rest of a woman's life. Calcium supplementation has gotten a very bad rap in recent years due to i ts negative impact on cardiovascular (CV) health. I maintain that the best way to provide added calcium is through food sources. As the typical metabolic demands of a pregnant woman are greater than those of non-pregnancy, increasing the intake of foods and with those foods, calories that are more fortified with calcium should be the favored approach. This is especially true in that many supplements tend to aggravate dyspepsia in pregnant women and food tends to ameliorate it.
Cochrane Database Syst Rev 2014 Jun 24; 6:CD001059
Averting Gestational Hypertension
Meta-analysis shows prenatal calcium supplements can prevent preeclampsia and preterm birth.
Preeclampsia is a serious cause of maternal morbidity and mortality, particularly in low-resource settings. To summarize global data about the effects of prenatal calcium supplements on gestational hypertension and associated morbidity, Cochrane reviewers conducted a meta-analysis of 13 high-quality trials including a total of 15,730 women. In most studies, supplements were begun at 20 weeks' gestation.
The number needed to treat (NNT) with calcium supplements (>1 g daily) to prevent 1 case of preeclampsia was 28, and the NNT to prevent 1 preterm birth was 40. Calcium supplements lowered risk for gestational hypertension by 35%, with the greatest effects among women with low-calcium diets and those at high risk for preeclampsia.
Comment Since 2011, the World Health Organization has recommended that pregnant women with low-calcium diets receive supplements of 1.5 g to 2 g daily. However, logistical challenges remain in ensuring that all who need such supplements receive them. Whether calcium combined with low-dose aspirin provides additional benefit to high-risk women deserves further study, but both agents have impressive cost-effectiveness and safety profiles.
Citation(s): Hofmeyr GJ et al. Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems Cochrane Database Syst Rev 2014 Jun 24; 6:CD001059.

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MM:I recently went shopping with my wife for a crib mattress for our new granddaughter. We are going to be the part-time "daycare" to help our kids out as they expand their family. In reality, we are simply eager to approach this new part of our lives. I found it interesting that all the cribs on display had bumpers, blankets and toys accompanying them. As the new recommendations for infants and cribs are protective in nature, I have to wonder if all stores are making parents, grandparents and other care givers aware of these guidelines or if they are merely promoting sales without instruction.
Sleep-Related Infant Deaths: Risk Factors Vary for Younger and Older Babies
By Amy Orciari Herman
Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Risk factors for sleep-related deaths vary based on infant age, but bed-sharing remains the biggest problem overall, according to a Pediatrics study.
Researchers examined over 8000 sleep-related deaths among infants younger than 1 year from 2004 through 2012. Over two thirds of the babies were bed-sharing — and one third had an object in the sleep environment — at the time of death.
Younger infants (age 0 to 3 months) were more likely than older infants (4 months to <1 year) to be sharing a bed or sleeping on an adult when they died, while older infants were more likely to be found in the prone position with objects (e.g., blankets, pillows) nearby.
The authors conclude: "Parents should be warned about the dangers of bed-sharing, particularly in 0- to 3-month-old infants. Although the American Academy of Pediatrics advises that infants do not need to be repositioned onto their backs if they roll into the prone position, parents should be reminded that cribs should be clear of any objects, so that if the infant rolls, there is no risk of rolling into something that may create an asphyxial environment."
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MM: Open-ended questioning rather than simple, yes or no responses is not always the preferred method of eliciting a response in a survey. As a result of this approach, many surveys tend to be limited in their validity and usefulness. The use of this single question approach appears to be much more useful and user friendly in computing the responses than other questioning approaches.
Single-Question Screening Can Help Identify Teens with Substance Misuse
By Amy Orciari Herman
Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
A screening tool based on a single question can accurately identify substance use disorders among teens, according to a study in JAMA Pediatrics.
Some 200 adolescents aged 12 to 17 at two outpatient primary care centers and one outpatient substance abuse treatment center completed an electronic screening tool that began with, "In the past year, how many times have you used [x]?" Use of eight substances, including alcohol, marijuana, and illegal drugs, was assessed. Participants who reported some use were asked follow-up questions based on their frequency of use. All participants also completed a structured diagnostic interview as the gold standard.
The screening tool took an average of 32 seconds to complete. It had a sensitivity of 100% and specificity of 84% for identifying nontobacco substance use; 90% and 94% respectively for substance use disorders; 100% and 94% for severe substance use disorders; and 75% and 98% for nicotine dependence. The screening tool was similarly accurate whether self- or staff-administered.
Alain Joffe of NEJM Journal Watch Pediatrics and Adolescent Medicine commented: "The importance of this study lies in its simplicity. Simply by asking a series of "How often have you used...?" questions and noting the frequency of use (if any) identifies the degree of concern a provider should have and what level of intervention the adolescent needs. Other than tobacco, monthly use of any substance is equivalent to a mild-moderate substance use disorder that could effectively be managed in a primary care physician's office while weekly use would require a more aggressive intervention."

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