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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
June 21, 2014

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Flu Season Wrap-Up: Less Illness and death than last Season
Too Much Vitamin D From A Tanning Bed
Higher Serum Vitamin D Linked to Lower Mortality Risk
Exercise Linked to More Diverse Gut Microbiota
Italy Funding Avastin for Unapproved Use
U.S. Can't Turn Inspections Over to Europeans

MM: The statements by the CDC regarding the flu from this past season make me wonder if the CDC reads its own information that it disseminates or if they read any of the peer-reviewed literature.
First: there were fewer people this year than in the past decade who received the flu vaccine and yet we had a very mild number of severe cases leading to severe illness or death.
Second: numerous studies have indicated the oseltamivir aka Tamiflu has virtually no benefit whatsoever on intensity, duration or any other parameter associated with the flu yet the CDC essentially sings its praises.
What is going on here?

Flu Season Wrap-Up: Less Illness and death than last Season
By Cara Adler
Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Influenza A H1N1 viruses predominated during this past flu season for the first time since the 2009 H1N1 pandemic, according to a CDC analysis of the 2013–2014 flu season published in MMWR. Influenza A H3N2 predominated in the intervening seasons.
Compared with last season, this season had lower rates of death and outpatient visits for influenza-like illness. However, hospitalization rates among patients aged 50 to 64 were higher. This season's activity peaked in late December to late January. Influenza A viruses predominated until late March, when influenza B viruses took over. All viruses were sensitive to oseltamivir and zanamivir.
Nearly all viruses analyzed were antigenically similar to the components of the 2013–2014 flu vaccine. The FDA has recommended that next season's vaccine have the same formulation.
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MM: This level of vitamin D is about 135 ng/ml. Is this a higher than expected level? Yes. Is this a dangerous level? No. I continue to be befuddled by why clinicians are perplexed by vitamin D levels greater than 100ng/ml. To the best of my knowledge, there are no examples of toxicity or ill effect on patients with levels under 200ng/ml. When will the medical community finally become enlightened that the recommended range of vitamin D is not optimal and is simply too low?
Too Much Vitamin D From A Tanning Bed
By Kelly Young
Edited by David G. Fairchild, MD, MPH, and André Sofair, MD, MPH

Clinicians should consider tanning bed use when evaluating patients with excessively high vitamin D levels, suggests a case report in the Annals of Internal Medicine.
A 26-year-old white woman was referred to an endocrinology clinic because her serum 25-hydroxyvitamin D level was above 339 nmol/L (the reference range is 75-185 nmol/L). She said she had minimal sun exposure and did not take supplements or consume inordinate amounts of dairy products.
She did, however, report using a tanning bed at least 3 times a week for the past 6 months. One month after being advised to stop tanning, her 25-(OH)D level had dropped to 182 nmol/L.
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MM: I continue to find it strange that clinicians will accept the use of low dose aspirin as a treatment for those who have a stroke or a cardiovascular event as an appropriate low cost treatment in spite of the increased risk of gastric ulcer and other adverse effects yet the notion that vitamin D3 supplementation and higher levels are merely attributed to people being in better health and taking better care of themselves as an explanation of lower overall mortality and morbidity. We see virtually no adverse effects from vitamin D and perhaps that is the reason that so many clinicians feel (not think) that it has such limited clinical value as a treatment modality.
Higher Serum Vitamin D Linked to Lower Mortality Risk
By Kelly Young
Edited by David G. Fairchild, MD, MPH
Higher vitamin D levels were associated with reduced mortality risk in a BMJ meta-analysis.
Researchers analyzed the results of eight cohort studies among some 26,000 adults aged 50 to 79 years in the U.S. and Europe. Compared with the highest quintile of serum 25-hydroxyvitamin D concentration, the lowest quintile was associated with increased risk for all-cause mortality (risk ratio, 1.57) and for cardiovascular mortality in people without a history of CVD (RR, 1.41) and in those with a history of CVD (RR, 1.65). There was also increased risk for cancer-related mortality, but only in people who'd previously had cancer (RR, 1.70).
The authors say their findings support the notion that 25(OH)D levels "might be a marker for a poor health status rather than a cause of premature mortality."
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MM: This is an interesting article in that it addresses what we typically consider very different systems being very closely related and having an effect on each other. Could it be that elite athletes are inducing significant stress on their bodies and that stress has an effect on cortisol and other stress hormones which in turn have an effect on the pH of the gut thereby creating an environment that makes it conducive for favorable gut microbiota to thrive and reduce systemic inflammation? Just a thought.
Exercise Linked to More Diverse Gut Microbiota
By Amy Orciari Herman
Edited by David G. Fairchild, MD, MPH, and André Sofair, MD, MPH
Intense exercise appears to have a beneficial impact on the microbial diversity of the gut, although concurrent dietary extremes are also involved, according to a study of elite athletes in Gut.
Forty professional Irish rugby players were matched to controls based on age, sex, and for half the controls, body mass index. Fecal samples were collected for analysis, and participants filled out food-frequency questionnaires. The diversity of gut microbiota was significantly higher among the athletes than controls. Protein intake was also significantly higher among the athletes, which correlated positively with gut biodiversity.
A commentator says this is "the first report that exercise increases gut microbiota richness/diversity and highlights that exercise is another important factor in the complex relationship among the host, host immunity and the microbiota."
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MM: Virtually all countries are realizing that healthcare expenses have gotten out of control and that many of the multinational drug manufacturers are taking advantage of the various healthcare systems. Yet, the United States seems to be going in the other direction in some cases. The Italian government is guiding compounding pharmacists to take a greater role and saving the government money while providing an enhanced quality of care for the recipients. The U.S. and the FDA are going in the opposite direction and making it more difficult for compounding pharmacists to do their job and take care of patients. This example of Avastin vs. Lucentis is a poignant example of this situation.
Italy Funding Avastin for Unapproved Use
Italy will pay for patients to use Avastin to treat an eye condition for which it's not approved, as the country looks to rein in medical costs. The decision by the Italian Medicines Agency will steer patients with age-related macular degeneration away from Lucentis, a similar but more expensive drug in Italy that regulators cleared for the same disease. Italy's antitrust authority had accused the companies of colluding to block the use of Avastin for the eyes. Other European governments may do the same as drug costs continue to increase.
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MM: Indian drug manufacturing facilities are grossly inadequate and dysfunctional. Virtually every generic manufacturing facility in India has been closed down due to standing water in production areas, poor temperature and humidity control, insect and vermin infestation and a variety of other sanitation and health violations. Would it surprise anyone to know that many of these manufacturing plants that have been closed down are owned by European drug manufacturers? Actavis, a Swiss company owns several plants in India, as do several other European firms.
U.S. Can't Turn Inspections Over to Europeans
European regulators, after having completed their assessment of drug manufacturing violations at Ranbaxy Laboratories Ltd.'s facility in Toansa, India said that although deficiencies were found, they pose no risk to public health. This assessment contradicts the response of U.S. regulators to the deficiencies found at the plant. The FDA has barred Ranbaxy from making and selling pharmaceutical ingredients from the Toansa facility to U.S. consumers." The FDA will not lift its ban on Ranbaxy until it is satisfied the products meet quality standards.

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