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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
April 19, 2014

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7 Million deaths Linked to Air Pollution in 2012
Widening Inequities in Breast Cancer Mortality Between U.S. Blacks and Whites
Androgen Deprivation Therapy for Localized Prostate Cancer
Physical Therapy Is Beneficial in Knee Osteoarthritis
Fecal DNA Testing Comes of Age
FDA Advisors Recommend Approval of Colon Cancer Screening Tests
A Distinctive Microbiome in Children with New-Onset Crohn Disease
CDC Autism Stats Show Wide Geographic Variation
Parental Obesity Seen as an Independent Risk Factor for Autism
Tamiflu, Relenza Data Show Little Clinical Benefit Against Flu
WHO Issues Its First Guidelines for Managing Hepatitis C Infection

7 Million deaths Linked to Air Pollution in 2012
Worldwide, about one in eight deaths — or 7 million — was attributable to air pollution in 2012, according to new estimates from the World Health Organization. That roughly doubles previous estimates.
The new estimates used data from satellites, ground-level monitoring, and pollution emissions.
Countries in southeast Asia and the western Pacific were hit the hardest, accounting for 3.3 million deaths associated with indoor air pollution and 2.6 million with outdoor air pollution. Most air pollution deaths were related to stroke, ischemic heart disease, or chronic obstructive pulmonary disease.
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MM: The wide disparity of deaths in black women compared to white women with breast cancer is likely due to a number of reasons. These may be genetic, socio-economic and environmental. We can't discount the effect of diet on health and the dietary commonalities of different ethnic groups and different geographical groups should not be ignored. To make the statement that the reviewer of this article that the disparity between the two racial groups is strictly a socio-economic one is, in my opinion, myopic and severely limited. Look at environmental factors and not just the inequities of income.
Cancer Epidemiol 2014 Mar 4
Widening Inequities in Breast Cancer Mortality Between U.S. Blacks and Whites
Analysis of data from the 50 largest U.S. cities documents growing racial disparity.
More than 232,000 U.S. women are projected to receive diagnoses of invasive breast cancer in 2014. Although breast cancer incidence is incrementally lower in black women than in white women, black women are more likely to die from this highly treatable malignancy. To assess temporal and geographic trends in this disparity, investigators calculated black-to-white mortality rate ratios (RRs) in the 50 largest U.S. cities during 5-year intervals from 1990 through 2009 (T1=1990–1994; T4=2005–2009). RR>1.0 indicates higher mortality for black women; RR<1.0 corresponds to higher mortality for white women.
The overall U.S. RR was 1.17 during T1 and grew to 1.40 by T4. During T4, no city-specific RRs were <1.0; however, 23 individual RRs were >1.0. From T1 to T4, RRs increased in 35 cities. New York City's RR was 1.18 at T1 and remained relatively constant. In contrast, the RR in Memphis was 1.27 at T1 and rose to 2.11 by T4. In the U.S., mortality rates in white women decreased by about 20% more than they did in black women. Each year, these racial disparities resulted in 1710 excess breast cancer deaths among black women (an average of 5 such deaths daily).
Comment: Triple-negative breast tumors, which are particularly aggressive, are more common in black women. However, genetic factors cannot explain the patterns reported here. For instance, the finding that the black-to-white rate ratio was almost twice as high in Memphis as in New York City probably reflects social disparities rather than biologic differences. I have often emphasized the role of improved treatments in the overall decline in breast cancer mortality (e.g., NEJM JW Womens Health Sep 22 2010, NEJM JW Womens Health Aug 11 2011). Black women, who are disproportionately poor and underinsured, have had less access to such treatments. Although these findings shed light on how far we are from achieving racial health equity, I hope that government healthcare reform will, by facilitating access, minimize these discouraging disparities.
Citation(s): Hunt BR et al. Increasing black:white disparities in breast cancer mortality in the 50 largest cities in the United States. Cancer Epidemiol 2014 Mar 4;
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MM: Androgen Deprivation Therapy for non-curative treatment may not be a treatment approach of choice for many men if they are choosing this route. It shows little clinical benefit and is accompanied by many life diminishing side effects. Ultimately, this is a decision that must be coordinated between patient and clinician.
J Clin Oncol 2014 Mar 17
Androgen Deprivation Therapy for Localized Prostate Cancer
Primary ADT has little utility for most patients who do not undergo curative-intent treatment.
Although the use of primary androgen deprivation therapy (ADT) as monotherapy in men with clinically localized prostate cancer may be slowly declining, recent evidence suggests that it remains a frequently used management approach for men older than 65. Moreover, previous risk-benefit assessments of primary ADT in this population have provided mixed results.Now, investigators have conducted a retrospective cohort study of 15,170 patients from one of three health plans with newly diagnosed, clinically localized prostate cancer who had not undergone curative-intent treatment with radiotherapy or surgery. Of these patients, 23% (median age, 76) received primary ADT within 12 months of initial diagnosis, and 77% (median age, 69) did not receive primary ADT. Patients who received ADT had worse prognostic factors, including higher Gleason scores and prostate-specific antigen values.
Patients who received primary ADT versus those who did not experienced higher rates of all-cause mortality (49% vs. 28%) and prostate cancer–specific mortality (13% vs. 5%). However, when the analysis was adjusted for clinical and sociodemographic features, primary ADT was associated with a decreased risk for all-cause mortality but not prostate-cancer–specific mortality for most patients.
Comment: These results add to the weight of evidence that primary androgen deprivation therapy has little utility for most men with clinically localized prostate cancer who, for a variety of reasons, are not managed with curative intent. The adverse effects and economic burden of ADT should be carefully weighed in this clinical setting.
Citation(s): Potosky AL et al. Effectiveness of primary androgen-deprivation therapy for clinically localized prostate cancer. J Clin Oncol 2014 Mar 17; [e-pub ahead of print].
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MM:A little bit of early post-surgical discomfort may be the key to having greater long term pain relief and successful outcomes later. Many people under-estimate the amount of pain and discomfort that they will experience after a surgical procedure. As a result, this may discourage them from PT shortly after their surgery. This study reinforces the benefits of early assertive action.
Arthritis Rheumatol 2014 Mar; 66:622
Physical Therapy Is Beneficial in Knee Osteoarthritis
Thrice-weekly exercise focused on quadriceps strengthening is a useful adjunct for OA patients.
Patients with knee osteoarthritis (OA) can be offered arthroscopy, medications, physical therapy (PT), or other treatment modalities. However, several randomized trials have suggested that arthroscopic interventions do not benefit most patients with knee OA (NEJM JW Gen Med Sep 16 2008 and NEJM JW Gen Med Jul 16 2002). In another study, PT was as effective as arthroscopy for meniscal tears in patients with OA (NEJM JW Gen Med Mar 28 2013). PT alone alleviates pain for many patients, but the optimal regimen is unknown.
To evaluate various PT regimens for patients with knee OA, researchers evaluated 48 trials in which PT was compared with non-exercise control interventions. The most efficacious PT programs provided aerobic, resistance, or performance exercises but did not mix exercise types. More pain reduction occurred with quadriceps-specific exercises than with other types of exercise. Best results were obtained with supervised, thrice-weekly PT programs with durations of at least 4 weeks.
Comment: Treating patients with knee osteoarthritis is not standardized. Patients can be offered analgesia, nonsteroidal anti-inflammatory drugs, steroid injections, hyaluronate compounds, arthroscopic interventions, or physical therapy. This study helps clinicians choose among these options. PT clearly helps relieve pain in patients with OA, and perhaps thrice-weekly PT for 4 weeks should be an adjunct treatment for all patients who are not responding to their current therapy.
Citation(s): Juhl C et al. Impact of exercise type and dose on pain and disability in knee osteoarthritis: A systematic review and meta-regression analysis of randomized controlled trials. Arthritis Rheumatol 2014 Mar; 66:622.
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MM: This is an exciting non-invasive assessment for determining the risk of colorectal cancer. The fecal occult test is a good qualitative test but this testing process may be greatly superior.
N Engl J Med 2014 Mar 19
Fecal DNA Testing Comes of Age
A combined fecal DNA assay and immunochemical test is established as the most sensitive, noninvasive, nonimaging screening test for colorectal cancer and precancerous polyps.
As the technology of fecal DNA testing has advanced, its sensitivity for colorectal cancer has increased. The latest iteration is a combination assay that includes molecular tests for KRAS mutations, aberrant NDRG4 and BMP3 methylation, β-actin, and an immunoassay for hemoglobin (i.e., a fecal immunochemical test, or FIT). Now, investigators have assessed its performance compared with FIT in detecting colorectal cancer in patients undergoing screening colonoscopy.
Of 9989 patients evaluated, 65 (0.7%) had colorectal cancer (60 with stages I–III), and 757 (7.6%) had advanced precancerous lesions (advanced conventional adenomas or large (≥1 cm) sessile serrated polyps). The sensitivity of the fecal DNA assay was 92.3% for cancer overall and 93.3% for stages I to III cancers, compared with 73.8% and 73.3% for FIT, respectively. Among the 757 individuals with advanced precancerous lesions, the sensitivity was 42.4% overall, 69.2% for high-grade dysplasia, and 42.4% for large sessile serrated polyps, compared with 23.8%, 46.2%, and 5.1% for FIT, respectively. The specificity of FIT was better compared with the fecal DNA assay in the population with normal colonoscopies or nonadvanced adenomas (94.9% vs. 86.6%) and in the population with normal colonoscopies (96.4% vs. 89.8%).
Comment: These findings establish the combined fecal DNA assay and fecal immunochemical test as the most sensitive, noninvasive, nonimaging test for colorectal cancer and precancerous polyps. For the first time, FIT is established as having essentially no value for the detection of serrated lesions, whereas DNA testing appears partly effective and promising. Although the fecal DNA assay is now established as superior to FIT in a single-use setting, the program sensitivity of each test remains uncertain. Because fecal DNA testing has traditionally been more costly than FIT and is likely to remain so, relative program sensitivity and cost-effectiveness will be of considerable interest. Selecting the optimal interval for the DNA assay will be a challenge, but recommendations of 3 to 5 years are likely. The lower specificity of the assay will be criticized and may challenge colonoscopy resources in some areas. Also, the positive-predictive value for cancer and advanced adenomas will be low, raising questions as to whether patients with false-positive tests should undergo repeat colonoscopy and imaging to detect extracolonic malignancy. Despite these limitations, the sensitivities described for this noninvasive assay are remarkable, and the story of fecal DNA testing has been one of consistent technological advancement.
Citation(s): Imperiale TF et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med 2014 Mar 19; [e-pub ahead of print].
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MM: For those who like to invest in up and coming medical areas, this would be a pretty good ground floor stock to look at. The aging population coupled with growing obesity and an increase on colorectal cancer among Americans are all factors that point to investing in these products and their manufacturers.
FDA Advisors Recommend Approval of Colon Cancer Screening Tests
By Kelly Young
A panel of FDA advisers voted unanimously in favor of recommending approval of the Cologuard device for colorectal cancer screening. It is designed to test patients' stool for hemoglobin, DNA methylation and mutation markers, and total amount of DNA, according to Reuters.
In addition, the group narrowly recommended approval of Epi proColon — a blood test for colorectal cancer — the Associated Press reports. The panel voted 5 to 4 that the benefits of the test outweighed the risks in people of average cancer risk. Epi proColon measures plasma levels of methylated Septin 9 DNA, which has been associated with colorectal cancer.
Patients who screen positive for either test would be referred for colonoscopy.
The FDA is not obligated to follow the guidance of its advisory committees, but it frequently does.

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MM: This is a very exciting study as it demonstrates the effect of gut flora on an auto-immune condition that is otherwise lacking a distinct cause. It may mean that directed probiotic therapy may be used as a definitive therapeutic tool for not only the treatment but potentially the cure for Crohn's Deiease.
Cell Host Microbe 2014 Mar 12; 15:382
A Distinctive Microbiome in Children with New-Onset Crohn Disease
Certain gut bacteria were amplified in ileal and rectal biopsy specimens
In recent years, researchers have reported that the microbiome of the gut is associated with inflammatory bowel disease, including Crohn disease (NEJM JW Gen Med Dec 31 2013). In various studies, not all researchers have identified the same microbiome “fingerprint” (the pattern of increased or decreased numbers of bacterial species). However, these reports have involved small numbers of patients, studied before and (often) after treatment, which makes interpreting the data difficult.
In a new multi-institutional study, investigators prospectively collected ileal and rectal biopsy specimens (and, often, stool specimens) from 447 children with new-onset, untreated Crohn disease and from 221 children with noninflammatory abdominal conditions. The presence and number of specific bacterial genera and species were determined with rapid gene sequencing technologies. Amplified numbers of certain bacteria (including Enterobacteriaceae and Fusobacteriaceae), and diminished numbers of others (including Bacteroidales and Clostridiales) predicted Crohn disease with relatively high reliability; organisms found on ileal and rectal biopsy specimens were better predictors than were organisms found in stool.
Comment: This study is, by far, the largest and most rigorous attempt to find a distinctive microbiome for new-onset Crohn disease. Whether this microbiome is a cause of or just an effect of the disease remains to be determined. This study surely will trigger more studies of whether the microbiome predicts disease course and whether altering the microbiome with probiotics is effective therapy.
Citation(s): Gevers D et al. The treatment-naive microbiome in new-onset Crohn's disease. Cell Host Microbe 2014 Mar 12; 15:382.

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MM: The enlargement of the Autism spectrum may be numbing us to the severe cases that exist. That is a danger of anything that we have increased exposure to. On the other hand, we must not ignore risk factors that may influence the future of our children, irrespective of the degree of damage that may ultimately be done. Although we have little control over family history, we must be vigilant when it comes to the use of medications during pregnancy. It is always appropriate to assess the risk vs benefit of any medical treatment. This is especially poignant when it comes to anti-depressants and pregnancy.
CDC Autism Stats Show Wide Geographic Variation
By Joe Elia
In 2010, 1 in 68 U.S. 8-year-olds in a surveillance network had autism spectrum disorder, according to MMWR.
The network, which comprises 11 sites that evaluate clinical data as well as school reports, found the prevalence per 1,000 8-year-olds varied from 5.7 (Alabama) to 21.9 (New Jersey). The condition was roughly four times more prevalent in boys, and the median age of earliest known diagnosis was about 4 years.
The authors point out that the sites are not necessarily representative of the entire country, and they warn against generalizing the results. They call for lowering the age at which children receive their first evaluation for the disorder and are enrolled in support systems.
Asked to comment on the report’s wider implications, NEJM Journal Watch child psychiatrist Barbara Geller observed that the apparently increasing prevalence of autism, along with its prenatal onset as documented in genetic and neuroimaging studies, “warrants informing pregnant patients about risk factors.” Those risk factors include family history and the use of antidepressants during pregnancy.
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MM: Here is a piece of data that has not been examined in the past and may be somewhat befuddling. We rarely look at the fathers of kids who are autistic but they do make up 50% of the DNA of the child and should not be ignored.
Parental Obesity Seen as an Independent Risk Factor for Autism
By Joe Elia
A Pediatrics study finds the risk for autism spectrum disorder strongly associated with paternal obesity (that is, with a BMI of 30 or more).
Investigators examined the relationship in a Norwegian cohort of some 93,000 children, whose health was tracked in national databases. By the end of follow-up, at a mean age of 7 years, the odds ratio for autism spectrum disorder among children of obese fathers was 1.53, compared with those of normal-weight fathers. Maternal obesity was not significantly associated.
The authors express surprise at the findings, which suggest an unidentified genetic or epigenetic mechanism.
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MM: I have been stating for years that these medications are as close to worthless as a medication can be. We have discovered that the general increasing of systemic vitamin D levels tp 60-80ng/ml has been one of the most beneficial actions that can be taken to protect our patients from colds and flu and that taking megadoses of 1000IU/lb of body weight for 3-5 days will typically diminish the intensity and duration of the ailment.
10-Tamiflu, Relenza Data Show Little Clinical Benefit Against Flu
By Joe Elia
The neuraminidase inhibitors oseltamivir (Tamiflu) and zanamivir (Relenza) have only marginal benefits in the treatment and prevention of influenza, a series of BMJ articles concludes.
Investigators reviewed documents submitted to regulatory agencies concerning both drugs.
Tamiflu data showed it reduced symptom duration by roughly 17 hours but made no difference in hospital admissions or rates of carefully defined pneumonia. Tamiflu increased nausea and vomiting. As prophylaxis, it greatly reduced symptomatic (but not asymptomatic) cases.
The Relenza analysis similarly showed a modest reduction in symptom duration (14 hours) and no effect on pneumonia. As prophylaxis, it acted like Tamiflu and had fewer side effects.
Editorialists observe that the analyses show "with greater clarity than ever" that the current system for drug regulation is broken. And one commented that, given these results, "it is difficult to conceive that many patients would actively seek treatment."
NEJM Journal Watch Infectious Diseases associate editor Stephen Baum wrote: "Clean out your medicine cabinet: these reviews call into question the drugs' efficacy and side effects, as well as the ways in which data were selectively used to promote them."
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WHO Issues Its First Guidelines for Managing Hepatitis C Infection
By Kelly Young
The World Health Organization has issued its first recommendations on screening for and treating hepatitis C infection.
Among the recommendations:

The authors also make specific treatment recommendations based on HCV genotype.

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