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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
May 10, 2014

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Calorie, Fat Consumption Up Among Statin Users
Melatonin for Drug-Induced Metabolic Syndrome
Careful Meta-Analyses Cast Doubts on Flu Drugs
Anxiolytics and Hypnotics Are Associated with Excess Mortality
Glucosamine for Knee Osteoarthritis: Another Negative Study
FDA Approves New Omega-3 Supplement
FDA Comes Out Against Aspirin for Primary Prevention of Heart Attack or Stroke
Severe Hypertension Linked to Caffeine-MAO Inhibitor Interaction
Physical Activity Improves Heart Rate Variability in the Elderly
Genes and Environment Play Equal Roles in Autism
A Combination Antibiotic Regimen for Active Ulcerative Colitis

MM: The statins have been promoted by our federal government, the AMA, the American Heart Association (AHA), the WHO and the Joint Commission as being protective of the cardiovascular system, fighting allergies, decreasing stroke and a myriad of other purported benefits. They have been acknowledged as having an extremely high risk of muscle cramps and pain. Now we discover that their use provides a false sense of security leading to increased BMI and metabolic syndrome, perhaps the leading source of all cause mortality and morbidity in western culture. It's time that we re-educate the public and the medical community that lifestyle change, nutritional supplements and weight loss/management programs such as the HCG Metabolic Syndrome Protocol must be the first step towards better health and not drugs.
Calorie, Fat Consumption Up Among Statin Users
By Amy Orciari Herman
Calorie and fat consumption increased significantly from 1999 to 2010 among statin users — but not among nonusers — according to a JAMA Internal Medicine study. The researchers conclude that "the importance of dietary composition may need to be reemphasized for statin users."
The researchers evaluated 24-hour dietary recall data from nearly 28,000 adults participating in U.S. nutrition surveys over the 12-year period. They found that among statin users, caloric intake was 10% greater, and fat intake 14% greater, in 2009-2010 than in 1999-2000. No significant increases were observed among nonusers. In addition, statin users had a greater increase in BMI than nonusers did (1.3 vs. 0.4 units).
The authors speculate that statin use "may have undermined the perceived need to follow dietary recommendations." They add that the aim of statin therapy "should be to allow patients to decrease risks that cannot be decreased without medication, not to empower them to put butter on their steaks."
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MM: Weight gain, among other adverse effects, has been a large reason that many patients discontinue their medication(s) or become non-compliant. This is especially the case with young women who are using this medication class. It is not uncommon for them to discontinue their medications due to a weight gain or increased belly fat concern.
Bipolar Disord 2014 Mar 17
Melatonin for Drug-Induced Metabolic Syndrome
In an early study, melatonin seems to decrease the weight gain that occurs with atypical antipsychotics.
Weight gain and other adverse metabolic consequences are common with atypical antipsychotics. Based on results from animal studies, researchers receiving industry support hypothesized that melatonin could help to attenuate these effects.
The 50 participants had been taking clozapine, olanzapine, risperidone, or quetiapine for <3 months and were randomized to 8 weeks of slow-release melatonin (5 mg) or placebo at 8 pm. Among the 24 patients with schizophrenia and 20 with bipolar disorder who completed the study (mean age, 29; 22 men), those taking melatonin had significantly lower mean diastolic blood pressure (BP), gained less weight (mean, 1.5 vs. 2.2 kg), and had less of an increase in waist circumference. After adjustment for baseline factors, melatonin in patients also taking mood stabilizers improved BP and yielded greater benefit on fat mass.
In disorder-specific analyses, melatonin-associated changes in fat mass percentage, fat mass, and diastolic blood pressure were found only in the bipolar group. Melatonin was associated with significant differences in diastolic BP with medium-risk atypicals and in changes in lean mass and total body water with high-risk atypicals.
Comment: One pos10sibility for the as-yet unknown mechanism of this finding is melatonin's effects on the suprachiasmatic nucleus and circadian rhythm, as circadian rhythm disturbances can have adverse metabolic consequences (NEJM JW Psychiatry Feb 14 2011). This study population is relatively small, and further studies are warranted. Also, melatonin did not reverse adverse changes, but only decreased them. Two important issues are whether starting melatonin when antipsychotic use is initiated would be more effective than starting later and whether immediate-release melatonin (which is what is generally available in the U.S.) would have different effects. However, slow-release melatonin is a promising and apparently low-risk strategy that may be helpful and should be considered.
Citation(s): Romo-Nava F et al. Melatonin attenuates antipsychotic metabolic effects: An eight-week randomized, double-blind, parallel-group, placebo-controlled trial. Bipolar Disord 2014 Mar 17; [e-pub ahead of print].
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MM: The promotion of these drugs and the endorsement of them by the WHO as "essential drugs" for flu is a travesty at best and fraud at worst. I have long contended that the most expensive treatment for anything is the one that does not works. These drugs are abject failures. Relenza costs about $75/diskhaler and Tamiflu is almost $150/cycle of use. Yet, they are still on the market, still being paid for by insurance companies, Medicare and Medicaid and still being prescribed by unwitting but well meaning clinicians. Much better choices for prophylaxis and treatment are good hand-washing hygiene, proper social attention to covering when coughing or sneezing, oral vitamin D3( 2000-10,000 units daily), vitamin C (2-3grams daily.
This combination is at least as effective and based on our clinical experience far superior to Relenza and tamiflu.
BMJ 2014 Apr 9; 348:g2547
Careful Meta-Analyses Cast Doubts on Flu Drugs
The Cochrane Collaboration again concludes that both oseltamivir(Tamiflu)  and zanamivir (Relenza) are overrated.
Cochrane reviewers have been skeptical about the efficacy of the neuraminidase inhibitors zanamivir (Relenza) and oseltamivir (Tamiflu) for treating patients with influenza (NEJM JW Gen Med Jan 5 2010). However, because much of the proprietary data on these drugs have been unavailable for public review, their conclusions have been tentative. Now, two new Cochrane reviews incorporate thousands of pages of previously unavailable data from the drugs' manufacturers.+
In a review of 20 randomized, controlled studies of oseltamivir, investigators concluded that the drug reduced mean duration of influenza symptoms in adults by about 17 hours (from 7 days to 6.3 days) and in otherwise healthy children by about 29 hours; the drug had no significant effect on duration of symptoms in children with asthma. Oseltamivir slightly lowered rates of unverified pneumonia among adults (but not among children) but had no effect on hospital admission rates among either adults or children. Because virtually no influenza-related deaths occurred among study participants, the drug's effect on mortality could not be addressed. In prophylaxis studies, the drug lowered the incidence of symptomatic influenza by 55% during 42 days of follow-up. Adverse effects included nausea and vomiting.
In a review of 26 studies of the inhaled medication zanamivir, researchers concluded that the drug reduced mean duration of symptoms by about 14 hours in adults (from 6.6 days to 6 days) and had no significant effect on duration of symptoms in children. Zanamivir did not prevent pneumonia, otitis media, or sinusitis among either adults or children. The studies did not report hospital admission rates. In prophylaxis studies, zanamivir lowered risk for symptomatic influenza in adults and children by about 60% during roughly 1 month of follow-up. No adverse effects were associated with the drug.
Comment: These two long, meticulously documented analyses deliver a consistent message: The neuraminidase inhibitors oseltamivir and zanamivir are modestly effective in preventing symptomatic influenza and minimally effective in treating it. Data regarding the much-hyped oseltamivir are particularly damning. In the words of the researchers, “these findings provide reason to question the stockpiling of oseltamivir, its inclusion on the WHO list of essential drugs, and its use in clinical practice as an anti-influenza drug.”
Citation(s): Jefferson T et al. Oseltamivir for influenza in adults and children: Systematic review of clinical study reports and summary of regulatory comments. BMJ 2014 Apr 9; 348:g2545.
Abstract/FREE Full Text Heneghan CJ et al. Zanamivir for influenza in adults and children: Systematic review of clinical study reports and summary of regulatory comments. BMJ 2014 Apr 9; 348:g2547.

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MM: These numbers are distressing as there are so many people who are using these medications for such a wide variety of issues. Anti-anxiety and sleep medications have been around for so long and are so widely accepted that their insidious danger potentials have become under-rated and discounted. These are strong medications that may not have a directly deleterious effect on health, may predispose people to other dangers that can very realistically threaten their lives.
BMJ 2014 Mar 19; 348:g1996
Anxiolytics and Hypnotics Are Associated with Excess Mortality
Even 1 year of use elevates risk.
Use of anxiolytic and hypnotic drugs such as benzodiazepines and Z-drugs (e.g., zolpidem [Ambien and generics], zaleplon [Sonata and generics]) is associated with adverse effects, including daytime fatigue, accidents, and falls (NEJM JW Gen Med Mar 28 2013). To determine whether people taking anxiolytic or hypnotic drugs are at elevated risk for death, investigators in the U.K. conducted a retrospective cohort study in which 35,000 primary care patients (age, ≥16) who were first prescribed anxiolytics, hypnotics, or both between 1998 and 2001 were matched by age, sex, and practice site with almost 70,000 patients for whom these drugs were not prescribed. Mean follow-up was 7.6 years.
After adjustment for age and multiple potential confounders, excess mortality was noted among users of benzodiazepines (hazard ratio, 3.7), Z-drugs (HR, 3.7) and other anxiolytic or hypnotic drugs (HR, 2.1) during the first year after they were prescribed. For all three drug classes, higher drug doses were associated with higher risk for death in a dose–response pattern.
Comment: In this study, use of benzodiazepines, Z-drugs, and other anxiolytic and hypnotic drugs was associated with elevated risk for death; dose–response relations were observed. Notably, many patients in this study were prescribed drugs from more than one class (e.g., 18% were prescribed both benzodiazepines and Z-drugs). Although confounding is possible, results of this study add to growing evidence that use of these drugs is associated with substantial harm.
Citation(s): Weich S et al. Effect of anxiolytic and hypnotic drug prescriptions on mortality hazards: Retrospective cohort study. BMJ 2014 Mar 19; 348:g1996.

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MM: Not all nutritional products contain what is described on their labels. This is, of course, blatant fraud. Unfortunately there is not an effective policing agency in the nutritional and vitamin industry to prevent this. The only assurance a consumer has is if the manufacturer is well known and follows cGMP's or Current Good Manufacturing Processes. With regard to glucosamine, I have always contended that he actual form/salt of the glucosamine is an important aspect. I have had very positive outcomes with Glucosamine sulfate but very inconsistent results with Glucosamine HCl. Several of these studies fail to differentiate what salt is being used, whether other pain meds are being used with the glucosamine or what other nutritional products are being used by the patient. The study described used the Glucosamine HCl product.
The other conflicting part of this study is that radiographic data is being used to assess success/failure and 30% of patients studied dad no radiographic indication of OA in the first place making the measure of efficacy highly suspect.

Arthritis Rheumatol 2014 Apr; 66:930
Glucosamine for Knee Osteoarthritis: Another Negative Study
Glucosamine did not affect knee structure or a marker of cartilage degradation.
A meta-analysis of randomized trials showed no clinical benefit from glucosamine in patients with knee or hip osteoarthritis (OA; NEJM JW Gen Med Oct 7 2010). Nevertheless, many patients take glucosamine, and some clinicians encourage its use because a few small studies suggested potential benefit and because no adverse effects are apparent. In this latest study, researchers (supported by the manufacturer of Regenasure glucosamine hydrochloride evaluated the effect of their product on joint structure (as assessed by magnetic resonance imaging [MRI]) and cartilage degradation (as assessed by the biomarker urinary C-terminal crosslinking telopeptide of type II collagen [CTX-II]).
Two hundred one adults (mean age, 52) with mild-to-moderate knee pain typical of OA received daily glucosamine (1500 mg) or placebo for 6 months; about 70% had radiographic features of OA. Compared with placebo, glucosamine did not protect against progression of cartilage damage on MRI, lower urinary CTX-II levels, or improve symptoms.
Comment: This study adds to the evidence against glucosamine for treating patients with knee osteoarthritis. Although 30% of enrollees did not have radiographic evidence of OA, the participants were typical of patients in the community who take glucosamine for knee pain that they (or their physicians) presume to be OA-related.
Citation(s): Kwoh CK et al. Effect of oral glucosamine on joint structure in individuals with chronic knee pain: A randomized, placebo-controlled clinical trial. Arthritis Rheumatol 2014 Apr; 66:930.

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MM: I am happy to see an increased endorsement of natural products but not necessarily at the greatly inflated cost to healthcare that must accompany FDA approved drugs. The good news is that more people who have dyslipidemia and elevated triglycerides will now consider alternative approaches. The bad news is that if these are widely accepted by the medical community, then there will be an even greater drain on healthcare costs due to an attitude of patient entitlement relative to prescription drugs.
FDA Approves New Omega-3 Supplement
By Larry Husten
The FDA has approved a new omega-3 supplement (brand name, Epanova) to treat adults with severe hypertriglyceridemia, defined as triglyceride levels 500 mg/dL or higher.
In its announcement, the manufacturer said that Epanova is the first omega-3 formulation approved by the FDA in free fatty acid form. It will be available in 1-g capsules and has been approved for 2-g and 4-g dosages, which can be taken with or without food.
There are currently two other prescription formulations of omega-3 supplements on the market: Lovaza and Vascepa. All three are approved only for the treatment of severe hypertriglyceridemia, though studies of expanded indications are underway.
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MM: It's hard to believe that this debate continues. It has been going on for several decades. There is no question that aspirin is damaging to the gut and will initiate ulcers and bleeding in many patients. The only remaining question is when is the risk of ulcer worth the potential benefits of its stroke or heart attack protection. There are too many people who are using aspirin as a preventative treatment when it is not appropriate and this must be emphasized to clinicians so that they will not make the improper recommendation.
FDA Comes Out Against Aspirin for Primary Prevention of Heart Attack or Stroke
By Larry Husten
Aspirin shouldn't be marketed for primary prevention of heart attack or stroke, the FDA has announced. The statement follows the agency's rejection on Friday of Bayer Healthcare's decade-old petition requesting approval of a primary prevention indication.
Aspirin is still widely used for primary prevention. The American Heart Association currently supports its use for primary prevention when recommended by a physician in high-risk patients. (There is widespread agreement that for secondary prevention, aspirin's benefits outweigh the risks, and it should be used to prevent a second heart attack or stroke after an earlier cardiovascular event.)
In its statement, the FDA said it had "reviewed the available data and does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke. In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain."
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MM: Coffee and other foods are not merely innocuous items that we consume. They have the potential to cause real good or real harm. This information must be identified and disseminated amongst the American public so that we do not fall victim to poor decisions.
Severe Hypertension Linked to Caffeine-MAO Inhibitor Interaction
By Amy Orciari Herman
High caffeine intake, when combined with monoamine oxidase (MAO) inhibitor therapy, can lead to severe hypertension, according to a research letter in the Annals of Internal Medicine.
Dutch researchers describe a middle-aged man who developed severe hypertension (220/119 mm Hg) after starting treatment with the MAO inhibitor tranylcypromine. The patient's blood pressure and heart rate peaked twice a day after tranylcypromine intake (previously, his blood pressure had been well controlled with hydrochlorothiazide). The patient's exam findings were otherwise normal. However, he reported drinking 10 to 12 cups of caffeinated coffee daily for years.
The patient stopped drinking coffee but continued tranylcypromine. Two weeks later, his blood pressure had normalized. When he began drinking decaf (10-12 cups/day), his blood pressure remained stable.
The authors note that caffeine has previously been shown to inhibit MAO and thus "might supplement the effects of MAO inhibitors." They conclude that providers "should consider limiting caffeine consumption" in patients with high intake who are using MAO inhibitors.
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MM: The message here is simple. Get up and move around. This is good advice no matter who you are, what your age is or what your health condition may be. Muscles are designed to be used and not perpetually be at rest. If they are not used, then they will atrophy. If no demands are made on the heart through physical activity, then, like any other muscle, it will cease to work at an optimal level.
Physical Activity Improves Heart Rate Variability in the Elderly
By Larry Husten
A new study in Circulation offers fresh evidence that physical activity is beneficial to the heart in people aged 65 and older. Benefits were observed both in elderly people who reported the highest amount of overall physical activity and in those who increased their physical activity over time.
U.S. researchers evaluated heart rate variability (HRV) using serial 24-hour Holter monitoring in 985 older adults over a 5-year period. They found that greater total leisure-time activity, walking distance, and walking pace were each associated with more favorable HRV indices. HRV has been previously shown to predict cardiac risk.
Increased physical activity was also associated with additional measures of improved cardiovascular risk, including a healthier circadian pattern. Any physical activity "is better than none, and more is better," write the authors. The results were consistent with previous studies in younger populations.
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MM: Nurture vs Nature has been a discussion associated with many maladies. The larger question is whether there is anything that we can do to diminish the likelihood of promoting these maladies or conditions. The blatant denial of the majority of the medical community, various government organizations and Big Pharma that environmental factors such as mercury preservatives or other environmental factors will influence the likelihood of ASD is reprehensible. It is our responsibility to protect our children from poison and harm when possible and, as parents, we can't do this if activities or practices contrary to this are forced upon us.
Genes and Environment Play Equal Roles in Autism
By Kelly Young
Genetic and environmental factors appear to be equal contributors to autism spectrum disorders, according to a JAMA study.
Using Swedish registries, researchers studied 2 million children who were siblings or cousins. During follow-up, nearly 15,000 were diagnosed with autism spectrum disorders (ASD).
The risk for autism by age 20 increased with increasing genetic relatedness. For example, an identical twin had 150 times the relative risk for an ASD if the other twin was diagnosed, while the relative risk for cousins was 2. Autism heritability was 50%, suggesting that environmental influence contributed the other 50%.
Editorialists conclude that this study "supports appreciation of the importance of genetic factors in ASD and adds substantial impetus to the growing attention to environmental influences in ASD etiology."
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MM: In reading articles like this I can't help but feel that they are missing the boat. If antibiotics can be beneficial for these conditions, why can't probiotics serve a similar purpose and perhaps not lend the potential of drug resistance or other side effects to the treatment? Just a thought to consider.
Aliment Pharmacol Ther 2014 May; 39:949
A Combination Antibiotic Regimen for Active Ulcerative Colitis
Response rates continue to be promising for amoxicillin, tetracycline, and metronidazole.
Bacteria are widely suspected to be one of the inciting antigens in ulcerative colitis (UC). As such, antibiotics, probiotics, and fecal microbiota transplantation have all been established or proposed as treatments for UC.
In the current open-label, multicenter trial, researchers assessed the efficacy of a combination of amoxicillin (500 mg), tetracycline (500 mg), and metronidazole (250 mg) 3 times daily for 2 weeks to induce and maintain remission in patients refractory to or dependent on steroids. The same researchers had previously designed this regimen to treat elevated levels of Fusobacterium varium observed in inflamed colonic mucosa of patients with ulcerative colitis and serum antibodies to F. varium. The regimen was effective for short-term control of UC in a randomized, double-blind, placebo-controlled study (NEJM JW Gastroenterol Aug 27 2010).
Among 30 patients with steroid-refractory, active UC (severe, 10; moderate, 19; mild, 1) and 64 patients with steroid-dependent, active UC (severe, 6; moderate, 51; mild, 7), a clinical response was achieved in 63.3% and 73.4%, respectively, within 2 weeks of completing therapy. At 3 and 12 months after completion, respective rates of clinical remission were 60.0% and 66.6% in steroid-refractory patients and 56.3% and 51.6% in steroid-dependent patients. At 3 and 12 months after completion, respective mucosal healing rates were 46.7% and 53.3% for steroid-refractory patients and 32.8% and 35.9% for steroid-dependent patients. In steroid-dependent patients, 60.9% were able to discontinue steroid therapy and remain in remission for ≥3 months.
Comment: The obvious weakness of this study is the lack of placebo control. However, the biologic plausibility based on prior studies of Fusobacterium varium, the previous short-term outcomes in a randomized trial, and the minimal cost and toxicity of this treatment compared with conventional alternatives indicate that this regimen is worth following closely for its potential to treat ulcerative colitis. It is also reasonable for use in clinical practice pending additional research.
Citation(s): Kato K et al. Adjunct antibiotic combination therapy for steroid-refractory or -dependent ulcerative colitis: An open-label multicentre study. Aliment Pharmacol Ther 2014 May; 39:949.

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