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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
December 13, 2014

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Can Immunization Be a Risk Factor for Multiple Sclerosis?
Middle Aged Midriff Bulge an Independent Risk factor for Sudden Cardiac Death
Causes of Neurologic Dysfunction in Celiac Disease and Gluten Sensitivity
Further Evidence that Hormone Therapy Is Safe Soon After Menopause
Prescription Drugs to Get New Labeling on Pregnancy Risks
Food for Thought: Guidance on Food Allergy
FDA Advisors Support Lifting Ban on Blood Donation by Gay Men

MM: Irrespective of what side of the fence a person is on regarding vaccinations, it has become increasingly apparent that by strengthening the immune system patients are less likely to have an adverse effect associated with vaccines. This may be done for all ages from prenatal to geriatrics. The daily use of probiotics, vitamin D3 and vitamin C supplementation tends to stabilize and enhance the immune system. These are reasons that we recommend these products for pregnant and nursing moms , children, adults and the aged. I see benefits to all groups of my patient base who regularly use these products. They are easy to use, inexpensive, extremely safe and most of all demonstrate effectiveness.
JAMA Neurol 2014 Oct 20
Can Immunization Be a Risk Factor for Multiple Sclerosis?
A case-control study shows a possible increased risk in the 30 days after vaccination.
Immunizations rarely result in delayed hypersensitivity reactions, which may manifest as neurological disease. The link between immunization and a chronic demyelinating disease such as multiple sclerosis (MS) has not been conclusively proven. Case reports suggest a temporal association but do not prove causation due to recall and publication biases.
To examine this possible association, researchers conducted a case-control study using data from more than 3 million members of the Kaiser Permanente Southern California healthcare system. Researchers ascertained all cases of MS and demyelinating disease by searching ICD9 codes and confirming the diagnoses using medical records. Five controls were selected for each case. The researchers obtained vaccination records for the 3 years before demyelination onset.
Of 780 patients with demyelinating disease, 4.0% had hepatitis B vaccination and 39.1% had human papilloma virus vaccination in the 3 years before symptom onset vs. 3.3% and 38.1% of controls, respectively. Neither of these single vaccines was associated with an increased risk at any time during the 3-year period. Vaccination of any type within the 3 years before symptom onset was recorded for 53.8% of those with demyelinating disease and 49.6% of controls. Among those younger than 50, the odds of any vaccination 30 days before demyelination-onset date were higher for cases than controls (odds ratio, 1.57; 95% confidence interval, 0.96–2.58); this difference was no longer significant from days 42 through 3 years.
Comment: Immunizations have dramatically reduced morbidity and mortality worldwide and represent one of the major successes in the history of medicine. Despite these benefits, patient apprehension continues about exceedingly rare complications of vaccination. In this study, the researchers found a slightly increased risk for demyelination in the 30 days after immunization, but this risk quickly equalized thereafter compared with controls. However, a causal relationship cannot be confirmed or refuted with these data. For example, patients may be more likely to report neurological symptoms when they occur in close approximation to a recent vaccination. Furthermore, studies of non-live virus in patients with MS have not shown an association with disease exacerbation (Neurology 2002; 59:1837). Healthy patients should continue to receive vaccinations, along with education about their benefits.
Citation(s): Langer-Gould A et al. Vaccines and the risk of multiple sclerosis and other central nervous system demyelinating diseases. JAMA Neurol 2014 Oct 20; [e-pub ahead of print].
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MM: I've always felt that BMI was sort of a worthless measure of health. Some people are very muscular and therefore weigh more. Others are thin but have very little muscle and are at health risks. It makes sense that central obesity would be a good risk assessment tool.
Middle Aged Midriff Bulge an Independent Risk factor for Sudden Cardiac Death
By Joe Elia, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
The association of general obesity with sudden cardiac death appears to be mediated through traditional cardiovascular risk factors, whereas abdominal obesity may pose an independent risk for sudden death, a Heart study suggests.
Some 15,000 middle-aged adults in four areas of the U.S. were followed for roughly 13 years. Sudden cardiac death occurred more often among those with higher baseline measures of body mass index, waist circumference, and waist-to-hip ratio. However, after adjustment for hypertension, diabetes, and coronary disease, only waist-to-hip ratio showed a direct association with sudden cardiac death (incidence rates among nonsmokers: 1.4 per 1000 person-years for highest waist-to-hip ratio vs. 0.37 per 1000 for normal waist-to-hip ratio).
The findings, according to editorialists, suggest that waist-to-hip ratio might be better than BMI for predicting sudden cardiac death. The mechanisms responsible for the association remain speculative, however.
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MM: I've heard many medical and lay people dismiss the notion of Gluten Sensitivity (GS) as merely a dietary fad and in many cases this is accurate. However, GS is a real problem for many people and it is more than simply discomfort as this article describes. It seems that the amount of gluten that many people with GS are exposed to is a key to the level of symptoms and, in many cases, GS may be diminished by simple avoidance and over time tolerance may be re-established. This is not the case for all but I have seen it work for several of my patients.
Neurology 2014 Nov 11; 83:1789
Causes of Neurologic Dysfunction in Celiac Disease and Gluten Sensitivity
An analysis of neurologic phenotypes and etiologies in patients with celiac disease and gliadin antibody–positive patients without celiac disease
Celiac disease (CD) is an autoimmune disease triggered by gluten, a protein in wheat, rye, or barley. CD affects about 1% of the population and typically is characterized by gastrointestinal complaints. Gluten sensitivity (GS) is an illness distinct from CD with a prevalence of about 6%. Patients with GS lack villous atrophy or second-generation antibodies (Tg2-IgA or -IgG, or deamidated gliadin IgA or IgG) but can test positive for antibodies to gliadin. Both CD and GS may present with various neurologic and psychiatric comorbidities such as ataxia, epilepsy, peripheral neuropathies, inflammatory myopathies, myelopathies, headache, and gluten encephalopathy (Psychiatr Q 2012; 83:91).
To identify the causes of neurologic dysfunction in patients with CD or GS, researchers reviewed the medical records of 68 patients with either CD or gliadin-positive CS, divided into three groups according to CD-prerequisite human leukocyte antigen (HLA) haplotype and CD serologic findings. Group 1 patients had the HLA-DQ2 or DQ8 haplotype and had second-generation CD serologic testing positivity (Tg2-IgA or -IgG, or deamidated gliadin IgA or IgG) during neurologic evaluation or had a duodenal biopsy-proven diagnosis of CD before the evaluation. Group 2 patients did not have HLA-DQ2 or DQ8 haplotype but had first-generation CD serologic testing positivity (gliadin IgA or IgG). Group 3 patients had the HLA-DQ2 or DQ8 haplotype and had gliadin IgA or IgG testing positivity.
In group 1, 42 of 44 patients had CD. Neurologic conditions in this group included cerebellar ataxia (13), neuropathy (11), dementia (8), and myeloneuropathy (5). Causes of neurologic dysfunction were autoimmune; deficiency of vitamin E, folate, or copper; genetic; toxic; metabolic; tardive akathisia; superficial CNS siderosis; or unknown. In groups 2 and 3, none had CD; 21 of 24 patients had cerebellar ataxia. Causes of neurologic dysfunction in groups 2 and 3 were autoimmune, multiple system atrophy, toxic, nutritional deficiency, other, or unknown.
Comment: These data support alternative causes to gluten exposure for neurologic dysfunction among patients who are gliadin antibody–positive but do not have celiac disease. In patients with CD, nutritional deficiency and coexisting autoimmunity may cause neurologic dysfunction. More research is needed to help disentangle CD from gluten sensitivity and to understand the mechanisms of gluten-associated neurologic and psychiatric complications.
Citation(s): McKeon A et al. The neurologic significance of celiac disease biomarkers. Neurology 2014 Nov 11; 83:1789.
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MM: This is good news for the women who experience the worst symptoms soon after menopause. However, I must emphasize that when women choose to discontinue estrogen therapy, many women must do this incrementally to limit the effects of the missing hormones.
Obstet Gynecol 2014 Nov; 124:947
Further Evidence that Hormone Therapy Is Safe Soon After Menopause
Finnish national analysis underscores the safety of HT in younger menopausal women.
Before the initial Women's Health Initiative (WHI) findings were published in 2002, many clinicians prescribed menopausal hormone therapy (HT) specifically to prevent coronary artery disease (CAD). In Finland, all deaths are recorded in a national register (with particular attention to accuracy regarding deaths thought to result from CAD), and all HT users since 1994 have been included in a national health insurance database, enabling rigorous study of HT use and CAD. As in many countries, use of HT in Finland plummeted in 2002. Researchers assessed use of systemic HT and CAD mortality before (1995–2001) and after (2002–2009) WHI publication in a total of >290,000 HT users compared with the background population matched for year and age.
During the pre-WHI period, HT use was associated with CAD mortality reductions of 29% (for ≤1 year of use) and 43% (for 1 to 8 years of use); post-WHI, percentage reductions in CAD mortality were 18% and 54%, respectively. Similar trends were noted with estrogen-progestin and estrogen-only HT. The HT-associated protection against CAD mortality was more pronounced in users younger than 60.
Comment: These Finnish findings that CAD mortality protection was greater in younger menopausal women are consistent with earlier WHI results (NEJM JW Womens Health May 3 2007) and support the “timing hypothesis” that estrogen is beneficial in younger women with healthy coronary vessels but not in older women in whom CAD prevalence is higher. I agree with the authors that the observational nature of their data does not allow endorsement of HT for preventing CAD. Nonetheless, these findings, along with long-term WHI follow-up (NEJM JW Womens Health Oct 11 2013), illustrate that, for menopausal women who are younger than 60 or within 10 years of menopause onset, initiating HT to treat bothersome vasomotor symptoms should be considered safe with respect to CAD
Citation(s): Tuomikoski P et al. Coronary heart disease mortality and hormone therapy before and after the Women's Health Initiative. Obstet Gynecol 2014 Nov; 124:947. (http://dx.doi.org/10.1097/AOG.0000000000000461)

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MM: The new labeling is clearer and more definitive. It should help both patients and practitioners who do not work with these labels every day to understand them.
Prescription Drugs to Get New Labeling on Pregnancy Risks
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
The pregnancy risks associated with prescription drugs and biologic products will soon be more clearly delineated on product labels with a new system that requires three new sections — "Pregnancy," "Lactation," and "Females and Males of Reproductive Potential" — rather than the current letter-based system (A, B, C, D, and X), the FDA announced on Wednesday.

The new system will go into effect at the end of June 2015

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MM: Although guidelines are frequently useful, I disagree with some of these. Especially the position that if there is a sensitivity problem, there is little reason to avoid or limit food additives. It is useful to specify many of the most common allergies because we can't simply assume that all practitioners are familiar with these.
J Allergy Clin Immunol 2014 Nov; 134:1016
Food for Thought: Guidance on Food Allergy
An updated practice parameter on diagnosis and management, with a focus on children
The three main allergy associations commissioned a practice parameter update on food allergy, diagnosis, and management. The 13-member task force considered results of impactful studies, guidelines, clinical reports, and meta-analyses. They graded each reference for overall strengths of recommendation (SOR) and level of evidence (LOE). Food allergy was defined as adverse health effects arising from specific immune responses occurring reproducibly on exposure to a given food.
Some relevant summary statements for dermatologists were:

Comment: Self-reported food allergy is more common than proven food allergy. Food allergy is more common in children than adults, and among children, more common in those with other atopic diseases (atopic dermatitis, asthma, allergic rhinitis). Cutaneous reactions to foods include IgE-mediated reactions (urticaria, angioedema, flushing, pruritus), cell-mediated reactions (contact dermatitis, dermatitis herpetiformis), and mixed reactions (atopic dermatitis). The authors cite evidence that food allergy may be a “significant trigger” for atopic dermatitis in 30% to 40% of infants and children. In my view, this number is too high.
Citation(s): Sampson HA et al. Food allergy: A practice parameter update—2014. J Allergy Clin Immunol 2014 Nov; 134:1016.
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MM: Maintaining a safe blood supply that is as untainted as possible is extremely important but it also makes sense that people who are demonstrably not at risk are allowed to contribute. Since testing and the sensitivity of these tests has improved so significantly, I endorse this new move by the FDA..
FDA Advisors Support Lifting Ban on Blood Donation by Gay Men
An FDA advisory panel has concluded that methods for testing donated blood for HIV have improved in recent years. This move could potentially set the stage for allowing gay men to donate blood again, the Wall Street Journal reports.
While they didn't take a formal vote on reversing the decades-long ban, most panel members said they supported the change. If the restriction is lifted, men could potentially donate blood if they have not had sex with a man in the past year. (A 1-year window allows enough time for new HIV infections to show up in tests on donated blood.)
Several advisors said the FDA should mandate that blood banks report cases of HIV transmission that occur through blood donations.

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