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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
October 25, 2014

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Drinking Non-Cow's Milk Linked to Lower Vitamin D Levels in Kids
When Are Patients with MS Most Prone to Relapse?
Does Dalfampridine Reactivate Trigeminal Neuralgia in People with Multiple Sclerosis?
Travelers from Ebola-Affected Nations Required to Enter U.S. Through Designated
   Airports; New PPE Guidelines
Monoclonal Antibody Treatment and Vaccine Produce Encouraging Results
   Against Ebola Virus
Study Behind the Green Coffee Bean Diet Craze Retracted
Black Women, Breast Cancer, and Lactation
Radiotherapy for Ductal Carcinoma In Situ After Breast-Conserving Surgery

MM: With the increasing number of children and adults who are discovering lactose and dairy protein sensitivity/intolerance, it is not surprising that vitamin D deficiencies are being noted. Is the answer fortifying other products in the food system or is it supplements of vitamin D3. I have issues with both approaches. Augmenting products in the food chain does not guarantee that a sufficient quantity will be consumed or delivered. There is not usually a monitor on the amount of foods that kids consume. On the other hand, unless nutritional products are producedd using cGMP's, there is no guarantee that he nutritional product has what it claims to contain. One thing is for certain. All the products that Mark Drugs provides in our Synergy Blends line of products are made using cGMP's and are thereby guaranteed to contain exactly what is listed on the label.
Drinking Non-Cow's Milk Linked to Lower Vitamin D Levels in Kids
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Children who drink non-cow's milk — such as soy, rice, almond, or goat's milk — have lower serum vitamin D levels than those who drink fortified cow's milk, according to a Canadian Medical Association Journal study.
Canadian researchers asked the parents of 2800 1-to-6-year-olds about their child's consumption of cow's milk, which is fortified with vitamin D, and non-cow's milk, for which fortification is voluntary. Children's serum 25-hydroxyvitamin D levels were also assessed.
More than 10% of children drank non-cow's milk daily. Children who drank only non-cow's milk had nearly three times the risk for having vitamin D levels below 50 nmol/L, relative to those who consumed only cow's milk. For children who drank both, every additional glass of non-cow's milk consumed daily was associated with a 5% reduction in 25-hydroxyvitamin D levels.
Commentators conclude: "Targeted vitamin D supplementation may be necessary for children who drink non-cow's milk beverages not regularly fortified with vitamin D."
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MM: There have been several impressive studies that have demonstrated the benefits of high dose oral vitamin D3 and MS. This study brings a statistical association with latitude, MS symptom relapse and full spectrum light exposure. I will continue to recommend high dose vitamin D3 to my MS patients.
Ann Neurol 2014 Oct 20
When Are Patients with MS Most Prone to Relapse?
An international consortium evaluates MS relapses by season.
The latitudinal gradient in multiple sclerosis (MS) has been hypothesized to be partially attributable to ultraviolet (UV) light exposure and its effect on vitamin D levels. Investigators used the global MSBase Registry to evaluate seasonal differences in relapses rates across 46 clinical centers in 20 countries. The dataset included 9811 patients who had a total of 32,762 relapses. Daily UV radiation (UVR) was recorded for all locations in the analysis, and UVR trough was determined.
Relapses followed a cyclical pattern, peaking in spring: Relapses were most common around March 7 in the northern hemisphere and September 5 in the southern hemisphere. Mean lag from UV radiation trough to relapse onset peak was 2.7 months, and for every 10 degrees of latitude away from the equator, peak relapse time decreased by 29 days.
Comment: This remarkable study illustrates the power of international databases to address what would seem to be very simple questions. The MS gradient has been a source of fascination for decades, but the reason for the observation was unclear. This study strongly implicates vitamin D as at least one factor contributing to the latitudinal variation, with relapse time peaking approximately 3 months after UVR nadir. Intervention trials with vitamin D are underway to determine whether relapses can be modified by supplementation.
Note to readers: At the time NEJM Journal Watch reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made
Citation(s): Spelman T et al. Seasonal variation of relapse rate in multiple sclerosis is latitude dependent. Ann Neurol 2014 Oct 20; [e-pub ahead of print].
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MM:As with all medications, adverse effects are a possibility and typically a probability. The question to ask is always, "Are the risks worth the benefits?", and which patients have the lowest risk quotient and which are at the greatest likelihood of seeing success? Although these very necessary questions essentially eliminate the "one size fits all" approach to treatment, it allows a more directive approach and should ultimately provide optimal results with a minimal risk factor.
Neurology 2014 Sep 26
Does Dalfampridine Reactivate Trigeminal Neuralgia in People with Multiple Sclerosis?
A new case series suggests caution may be warranted.
Dalfampridine, an extended-release formulation of the potassium channel blocker 4-aminopyridine, is licensed in the U.S. as a symptomatic therapy to improve walking speed in people with multiple sclerosis (MS). Dalfampridine may also provide symptomatic benefit in other functional neurologic domains in patients with MS and other neurologic diseases. A new case series suggests that dalfampridine may aggravate or trigger trigeminal neuralgia.
Of 71 patients with clinically definite MS in an MS subspecialty practice who had been prescribed dalfampridine for the on-label indication, 3 had histories of trigeminal neuralgia and 2 had histories of unilateral episodic altered facial sensation. Of the 3 patients with prior trigeminal neuralgia, all of whom had symptoms that were reasonably well controlled, all experienced worsening of facial pain within 1 month after starting dalfampridine (and 2 of the 3 within 2 weeks). One of the patients with unilateral intermittent facial dysesthesias developed facial pain 18 months into dalfampridine therapy. Upon stopping dalfampridine, the pain initially improved in all, but over time became harder to control in the three with preexisting trigeminal neuralgia. One patient ultimately underwent a unilateral trigeminal rhizotomy.
Comment: Although causation remains unproven and the sample size of this case series is small, the authors reasonably advise caution prescribing dalfampridine in MS patients with histories of trigeminal neuralgia. Additional surveillance studies will be informative in clarifying this potential association. Dr. Gelfand is Assistant Professor of Clinical Neurology, MS Center, University of California, San Francisco.
Citation(s): Birnbaum G and Iverson J.Dalfampridine may activate latent trigeminal neuralgia in patients with multiple sclerosis. Neurology 2014 Sep 26; [e-pub ahead of print].
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MM: One of my concerns for failure of the protective systems is that significant and potentially costly demands are being placed on providers but there may not be a means of compensation for these protective measures and this could lead to cutting corners and defeat of the intent of the program.
Travelers from Ebola-Affected Nations Required to Enter U.S. Through Designated Airports; New PPE Guidelines
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
The U.S. is requiring that people traveling from Sierra Leone, Guinea, and Liberia enter the U.S. through one of five designated airports that are set up to screen for Ebola: New York's JFK, Newark, Dulles, Atlanta, and Chicago's O'Hare.
In addition, the CDC has issued new guidance on the personal protective equipment (PPE) that healthcare workers should wear when treating suspected Ebola patients. The three basic principles include:


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MM: Monoclonal Antibody treatments (MAB's) are a very exciting class of drugs but may carry very debilitating side effects. Before we endorse these vaccines or treatments it is extremely important that these treatments are directed at those at greatest risk and not to the general population.
Nature 2014 Oct 2; 514:47
Monoclonal Antibody Treatment and Vaccine Produce Encouraging Results Against Ebola Virus
Treating and preventing Ebola infections is possible.
Two research groups report encouraging results in treating and preventing Ebola infections in nonhuman primates.An international team tested a combination of several monoclonal antibodies (ZMapp) that has shown efficacy against Ebola virus in primates (rhesus macaques). The antibodies were administered to 18 monkeys, with the first dose given 3 to 5 days after the animals were inoculated with the virus. Three control animals were inoculated with the virus but not treated. Almost all of the animals experienced symptoms and signs of Ebola infection and had laboratory markers of disease at the time of first antibody treatment. All of the treated animals survived, whereas all of the controls died.
A second international team reported progress with a vaccine. Past research shows that human-derived adenovirus-type vectors containing Ebola virus antigens generate a potentially protective immune response — except in the considerable fraction of people who have been exposed to human adenovirus in the past and who consequently have antibodies against human adenovirus vectors. Therefore, the researchers developed a chimpanzee-derived adenovirus vector. In macaques, the vaccine rapidly induced both acute and durable protection against an Ebola virus challenge given 5 weeks after immunization. In unvaccinated animals, the virus challenge was lethal.
Comment: The success in nonhuman primates of these two therapies — passive antibody treatment of established disease and durable prophylaxis against subsequent disease — offers hope that we can find better ways of curtailing outbreaks of disease caused by Ebola virus.
Citation(s): Qiu X et al. Reversion of advanced Ebola virus disease in nonhuman primates with ZMapp. Nature 2014 Oct 2; 514:47. (http://dx.doi.org/10.1038/nature13777)

Stanley DA et al. Chimpanzee adenovirus vaccine generates acute and durable protective immunity against ebolavirus challenge. Nat Med 2014 Oct; 20:1126. (http://dx.doi.org/10.1038/nm.3702)

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MM:I have been asked many times if I could recommend a weight loss product that would be effective and non-prescription. As I review the data I continue to find that there are very few products that can consistently be trusted to be effective. Various weight loss strategies have shown temporary success but if a person can't maintain the strategy for their entire life, they will invariably gain all or most of the weight that they have lost and in many instances will end up heavier than they started. The only product coupled with a plan that I have found to work long term and consistently is the HCG weight loss and Metabolic Syndrome management plan. It consistently shows significant fat loss, not just weight loss, and patients tend to keep the weight off for years, not just weeks. No matter what approach is taken for weight loss, if a person returns to their old eating and lifestyle habits, then they will undoubtedly regain weight that they have lost. The difference with the HCG program is that is lasts longer than other programs since a greater percentage of fat vs muscle is lost in the process. Stay away from other fad diets. They simply don't work long term and may ultimately cause harm. Having had more than 40,000 cycles of patients use the HCG protocol, in our clinical experience, it doesn't appear to have either of these downfalls.
Study Behind the Green Coffee Bean Diet Craze Retracted
By Larry Husten, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
The study that helped ignite the green coffee bean diet craze has been retracted. The details of the retraction and the full background of the story were reported on Retraction Watch.
The paper, published in Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, claimed to report results from a randomized, double-blind, placebo-controlled crossover study of green coffee bean extract. Following the study's publication, the Dr. Oz Show featured the product, and it soon became an international bestseller.
In September, the extract's manufacturer settled Federal Trade Commission charges of marketing the product based on this study. In a news release, the FTC said that "the study was so hopelessly flawed that no reliable conclusions could be drawn from it." According to the FTC: "The study's lead investigator repeatedly altered the weights and other key measurements of the subjects, changed the length of the trial, and misstated which subjects were taking the placebo or [green coffee antioxidant] during the trial."
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MM:I related the results of this article to my wife and she reminded me that a dear friend of ours had nursed her son yet developed breast cancer and perished from it. The question arose, if our friend nursed, why did she still develop breast cancer? This was an excellent question. One would think on the surface, that if a person breast feeds, then they would be at a reduced risk for cancer. It is important to look at the details of a study. In this study it is noted that ER- tumors were beneficially responsive to breast feeding but ER+, a very common genotype, were not.
J Natl Cancer Inst 2014 Oct; 106:dju237
Black Women, Breast Cancer, and Lactation
Mothers who don't breast-feed are at increased risk for aggressive breast cancer.
Breast cancers lacking estrogen receptors (ER−) carry a worse prognosis and are more common among black women in the U.S. To examine the relation between parity, lactation, and breast cancer subtypes, investigators for the African American Breast Cancer Epidemiology and Risk (AMBER) consortium analyzed data pooled from 4 studies including 3698 black women with breast cancer and 14180 without breast cancer.
In both unadjusted and multivariable analyses, risk for ER+ breast cancer was not affected by parity, but risk for ER− breast cancer increased with each additional birth among mothers who had not breast-fed. Overall, lactation did not affect risk for ER+ cancer but was associated with a 19% reduction in risk for ER− breast cancer.
Comment: Weaning is hypothesized to result in gradual involution of breast tissue, whereas not breast-feeding is associated with more-abrupt activation of fibroblasts and an influx of tumorigenic cells. Although findings similar to those of this study were previously reported in a predominantly white population, these results confirm that disparities in access to lactation support (as well as employment environments that enable mothers to pump while working outside the home) seem directly linked to persistent disparities in breast cancer morbidity and mortality in the U.S. (NEJM JW Womens Health Sep 23 2014).
Citation(s): Palmer JR et al. Parity, lactation, and breast cancer subtypes in African American women: Results from the AMBER Consortium. J Natl Cancer Inst 2014 Oct; 106:dju237.
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MM: The predominant treatments for breast and other cancers are radiation and chemotherapy. Neither of these are without adverse effects however the general and medical communities accept these negative effects because we understand that these treatments are the "best" options for prolonged life. This study questions that premise.
J Clin Oncol 2014 Oct 13
Radiotherapy for Ductal Carcinoma In Situ After Breast-Conserving Surgery
At 20-year follow-up, radiotherapy reduced absolute risk for local recurrence but did not improve survival; concerns about overtreatment remain.
The original SweDCIS trial of whole-breast radiotherapy versus observation after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS) involved 1046 patients treated from 1987 to 1999 (Acta Oncol 2006; 45:536). In a prior update of that trial (J Clin Oncol 2008; 26:1247), the authors reported that, at 10 years, the use of radiotherapy reduced the absolute risk for local recurrence by 16% compared with observation (95% confidence interval, 10.3–21.6) but did not improve distant metastasis-free survival.
In a new update, the authors report that, at 20 years, the use of radiotherapy reduced the absolute risk for local recurrence by 12% (10% for in situ disease and 2% for invasive breast cancer; 95% confidence interval, 6.5–17.7) and did not improve breast cancer–specific survival and overall survival.
Comment: Principal controversies surrounding the diagnosis and management of DCIS include concerns that patients, especially older ones, may be overtreated, either with mastectomy or radiotherapy after BCS for small low- and intermediate-grade lesions. Radiotherapy is highly effective for preventing DCIS recurrences after BCS, but it does not affect survival. Moreover, the absolute risk for DCIS recurrence of smaller lesions without radiotherapy, particularly among postmenopausal women, appears to be lower in more recent studies that incorporate advances in mammography and techniques to ensure negative margins of resection (Int J Radiat Oncol Biol Phys 2012 Nov; 84:S5 and Ann Surg Oncol 2012 Nov; 19:3777). The next wave of DCIS trials in Europe has begun to address the safety of observing core biopsy-proven DCIS without surgical excision, radiotherapy, or endocrine therapy. For example, the UK Low Risk DCIS trial (LORIS) is randomizing patients with low- and intermediate-grade DCIS of any size to active monitoring (biopsy alone without surgical intervention) or standard therapy.
Citation(s): Wärnberg F et al. Effect of radiotherapy after breast-conserving surgery for ductal carcinoma in situ: 20 years follow-up in the randomized SweDCIS trial. J Clin Oncol 2014 Oct 13; [e-pub ahead of print].
Recht A.Are the randomized trials of radiation therapy for ductal carcinoma in situ still relevant? J Clin Oncol 2014 Oct 13; [e-pub ahead of print]. (http://dx.doi.org/10.1200/JCO.2014.58.1066)

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