• FDA Continues Work in Identifying Substances Appropriate for Compounding
• FDA Attack on Supplements
• FDA Overstepping its Authority--Again
• Vitamin B3 Tied to Lower Risk for Nonmelanoma Skin Cancer
• Two-Year Trial Supports Cardiometabolic Benefits of Moderate Wine Consumption
• BRCA Testing in Community Practice
• Mole Count on One Arm Predicts Total Body Mole Count
• Methicillin-Susceptible Staph Infections Cause More Deaths Than MRSA Among NICU Babies
MM: The FDA is once again over-stepping its authority. They are attacking the compounding of supplements. This is not what the intent of Congress or the Senate was when they enacted the Drug Quality Security Act (DQSA) in order to protect the public from contaminated or unsafe products. The very nature of compounding is the production of unique products or strengths that are not commercially available and that meet the specific needs of the patients that are not met by the products provided to the general public. Very recent examples of this are the use of Hi Dose Biotin for Chronic Progressive Multiple Sclerosis (MS) patients and the use of high dose Vitamin B3 used against melanoma (see the article following these commentaries). These new acts of the FDA have the effect of putting people at increased risk of cancer and death but also of denying a group of patients (Biotin 300mg daily for chronic progressive MS patients) the only treatment that has been demonstrated to be safe and effective for them.
FDA Continues Work in Identifying Substances Appropriate for Compounding
[August 1, 2015; AJHP News]
Even though there is a USP dietary supplement monograph for N-acetyl-D-glucosamine, the substance does not automatically qualify for use in compounding drug products, The FDA's lead on compounding issues revealed during a recent Pharmacy Compounding Advisory Committee (PCAC) meeting.
"We don't consider dietary supplement monographs to be the kind of monographs that they [legislators] were referencing in the statute as being OK to compound," Jane Axelrad said. "It has to be on this list."
The list, which does not yet officially have any entries, names bulk drug substances that pharmacists and physicians may use to compound prescription drug products despite those substances lacking an "applicable"USP or National Formulary monograph and not being a component of any FDA-approved drug product.
"It's a cumbersome process," Axelrad said of placing a substance on the list.
http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?Source=
News&Type=Rss&Id=4227
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FDA Attack on Supplements
The FDA's hostility toward both supplements and compounded medicine is legendary-after all, they compete with the FDA-approved drugs that pay the government's bills. Now the agency is attacking compounded supplements.
The House Appropriations Committee recently scolded the FDA for implementing the law "in a manner inconsistent with its legislative intent." This isn't the first time that members of Congress have made it clear that the FDA is going too far in its compounding regulations.
Despite these warnings, the FDA continues its attack on compounding. Where in the legislation does it say that the FDA can ban compounded supplements?
http://www.anh-usa.org/fda-compounds-its-attack-on-supplements/
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FDA Overstepping its Authority--Again
At a recent PCAC meeting, an FDA representative said that nutritional supplements will need to be on a pre-approved list in order to be compounded. However, nowhere in the legislation does it say that the FDA can ban compounded supplements.
http://www.anh-usa.org/action-alert-fda-attack-on-compounded-supplements/
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MM: The dose of Vitamin B3 in this study was 500mg given twice daily for a total of 1000mg daily. Although this is a significant daily dose, it does not represent a great general risk to the patient. One of the important things to know about the "B" vitamins is that they need to be presented in a balanced format so if a person decides to take a single B vitamin in an exceptionally high dose then they need to take an additional Balanced B Complex so that their utilization of all the B vitamins will stay in check. Mark Drugs has developed a Balanced B Vitamin called Synergy-B. It provides the proper distribution and combination of the B vitamins to help patients who are taking a high dose of a particular B vitamin stay balanced and healthy while deriving the maximum benefits from their nutritional therapy.
Vitamin B3 Tied to Lower Risk for Nonmelanoma Skin Cancer
By Kelly Young, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Nicotinamide, a form of vitamin B3, is associated with reduced risk for developing nonmelanoma skin cancer among high-risk patients, according to a phase III trial published in the New England Journal of Medicine. Early trial results were presented at the American Society of Clinical Oncology's annual meeting in May.
Nearly 400 adults with two or more nonmelanoma skin cancers in the past 5 years were randomized to receive nicotinamide or placebo twice daily for 12 months. Nicotinamide, an over-the-counter vitamin supplement, stops ATP depletion and glycolytic blockade prompted by ultraviolet radiation.
After 12 months, the primary endpoint — the number of new nonmelanoma skin cancers — was significantly lower in the nicotinamide group (1.8 vs. 2.4 per person). The advantage was only statistically significant for squamous-cell carcinomas and disappeared after patients stopped treatment.
http://www.nejm.org/doi/full/10.1056/NEJMoa1506197
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MM: The question comes up frequently about whether it's beneficial or harmful to drink wine or other alcoholic beverages on a regular schedule. This study demonstrates that moderate consumption on a regular schedule in conjunction with a Mediterranean diet is potentially beneficial for heart health and sleep. Other studies have demonstrated benefits from this combination as well while several have shown no significant benefit from wine only. The combination seems to be the greatest positive factor along with prudent sunlight exposure to complement the regimen by supporting vitamin D3 levels.
Ann Intern Med 2015 Oct 13; 163:569.
Two-Year Trial Supports Cardiometabolic Benefits of Moderate Wine Consumption
In a randomized study, daily wine drinkers acquired potential health benefits over water drinkers.
Many observational studies have shown that moderate alcohol drinkers have lower incidences of type 2 diabetes mellitus and cardiovascular disease than do nondrinkers or heavy drinkers. Mixed results have been reported on whether red wine has special benefits over other alcoholic beverages.
An international group conducted a study that involved 224 Israeli adults (age range, 40–75) with type 2 diabetes who regularly drank no more than one alcoholic drink weekly at baseline. The participants all ate a Mediterranean diet, without caloric restriction, and were randomized to drink 150 mL of red wine, white wine, or mineral water each evening (drinks were provided for free). Adherence was excellent. At 2 years, compared with water drinkers, the red wine drinkers had higher HDL cholesterol levels (by 2 mg/dL), lower total/HDL cholesterol ratios, and fewer markers for metabolic syndrome; the white wine drinkers had lower fasting blood glucose and triglyceride levels and less insulin resistance. No between-group differences were found in blood pressure, adiposity, liver function, drug therapy, symptoms, or quality of life (except that wine drinkers reported sleeping better).
COMMENT: This 2-year controlled trial in adults with type 2 diabetes suggests that red wine has modest benefits for raising HDL cholesterol levels and preventing metabolic syndrome, whereas white wine might improve carbohydrate metabolism modestly. The study was not designed to evaluate clinical outcomes or the incidence of new-onset type 2 diabetes, and its results might not apply to adults who don't have diabetes already.
CITATION(S): Gepner Y et al. Effects of initiating moderate alcohol intake on cardiometabolic risk in adults with type 2 diabetes: A 2-year randomized, controlled trial. Ann Intern Med 2015 Oct 13; 163:569.
(http://dx.doi.org/10.7326/M14-1650)
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MM: Genetic testing can be confusing and a bit scary to the general public. It is a relatively new field and there are few practitioners who truly understand all of the implications. Couple this with the rapidly growing research and knowledge that is being generated and it is easy to see why there is such a large gap in the system that communicates and explains these tests.
JAMA Oncol 2015 Oct 1
BRCA Testing in Community Practice
Most women undergoing BRCA testing do not receive counseling from a genetics clinician.
Testing for BRCA mutations is readily available in the community, and patient awareness of “genetic testing” to determine susceptibility for cancer is increasing. However, the knowledge base to adequately counsel patients regarding the implications of BRCA testing is neither consistent nor uniform across medical specialties.
To better understand the experience of patients undergoing BRCA testing in the community, the American BRCA Outcomes and Utilization of Testing (ABOUT) study was undertaken to analyze data from women who had BRCA testing ordered by their clinicians. More than 11,000 women who had been referred for testing were sent questionnaires concerning their BRCA1 and BRCA2 knowledge, understanding of information prior to testing, and satisfaction with the information received prior to testing.
The 3628 respondents were more likely to be non-Hispanic whites, college-educated, and married and to have higher incomes. Only 36.8% of respondents received genetic counseling from a genetic counselor, and women who were referred for testing from an obstetrician-gynecologist were the least likely to be referred for genetic counseling (12.3%). The most common reason for not being evaluated by a genetic counselor was lack of a referral for genetics counseling from the clinician. Women receiving counseling from a genetic counselor scored higher on knowledge of BRCA, greater understanding, and overall satisfaction, compared with those not seeing a genetic counselor. Mutations were identified in only 5% of those undergoing testing.
COMMENT: At first blush, the impact of genetic counselors on patient understanding and satisfaction are clear, but as an editorialist points out, several more issues need to be considered. The need to provide counseling to every person undergoing testing will quickly outstrip the existing manpower, and the current state of science regarding genes beyond BRCA1/2 that put individuals at risk for developing cancer is rapidly evolving. The ability to convey this growing knowledge base will become progressively more challenging, as will the layperson's ability to understand this new information. Newer strategies for educating individuals undergoing testing will need to be developed.
CITATION(S): Armstrong J et al. Utilization and outcomes of BRCA genetic testing and counseling in a national commercially insured population: The ABOUT study. JAMA Oncol 2015 Oct 1; [e-pub].
(http://dx.doi.org/10.1001/jamaoncol.2015.3048)
Narod S.Genetic testing for BRCA mutations today and tomorrow — about the ABOUT study. JAMA Oncol 2015 Oct 1; [e-pub].
(http://dx.doi.org/10.1001/jamaoncol.2015.3269)
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MM: Simple, non-invasive, low cost testing methods seem to be rarely available. This approach of simply counting the number of moles on a single arm is innovative and appears to be statistically significant. However, the fact that there are a certain number of moles, either high or low, should not give a person a false sense of security or on the other extreme, fear. Subsequent observation and further testing if skin lesions are present should also be considered.
Mole Count on One Arm Predicts Total Body Mole Count
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
The number of moles, or nevi, on one's arm is predictive of the number of moles on the rest of the body — which in turn is associated with melanoma risk — according to a study in the British Journal of Dermatology.
Researchers conducted full-body skin examinations, focusing on 17 body sites, on nearly 3700 twin white females in the U.K. and 415 white male and female controls.
Nevi on the arms were most predictive of total body nevus counts in both groups. In the twin study, women with more than seven nevi on the right arm had nearly nine times the risk for having over 50 total body nevi, relative to those who had fewer than seven on the arm. In addition, those with more than 11 on the arm had nine times the risk for over 100 total body nevi, "that is in itself a strong predictor of risk for melanoma."
The researchers conclude: "This fast clinical evaluation should be used for a quick estimation of melanoma risk in general practices."
http://onlinelibrary.wiley.com/doi/10.1111/bjd.14216/epdf
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MM: When we enter a hospital we generally assume that good hygiene practices are the norm but in reality this is not always the case. People who work in hospitals are just people. They are subject to exposure to the same bugs and germs as the rest of the population and when in the hospital environment, more virulent strains of these bugs. These caregivers may focus on washing their hands more often than the general population would but they are also exposed to a greater concentration of possible infectious sources. With all of this in mind, it becomes even more important that when you have a loved one in the hospital or a newborn in the hospital, that you are more vigilant that normal about making certain that you, your loved ones who are visiting and the caregivers wash their hands when entering or exiting a patient environment and wear a mask if they have a cold, cough or other respiratory inflammation to protect that newborn or other patient.
Methicillin-Susceptible Staph Infections cause more Deaths than MRSA among NICU Babies
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Among infants in the neonatal ICU, methicillin-susceptibleStaphylococcus aureus (MSSA) infections are more common than methicillin-resistant infections (MRSA) and lead to more deaths, a JAMA Pediatrics study finds.
U.S. researchers studied nearly 4000 infants with invasive S. aureusinfections who were discharged from one of 350 NICUs between 1997 and 2012. Roughly three quarters of infections were MSSA, while the remainder were MRSA. For infants with mortality data, the number of deaths before hospital discharge was higher among infants with MSSA versus MRSA infections (237 vs. 110), although the proportion of those who died in each group did not differ significantly (10% and 12%).
Editorialists write: "These and other reports suggest that measures to prevent MRSA infections should be broadened to include MSSA and that hospital infection control policies and practices that traditionally have focused only on MRSA should include MSSA as well.
http://archpedi.jamanetwork.com/article.aspx?articleid=2449666
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