Target Health Presenting at the 15th Annual eClinical Integration Summit

 

Target Health is pleased to announce that Dr. Jules T. Mitchel, will be presenting at a panel during the 15th Annual eClinical Integration Summit, being held on September 19-21, at the Seaport Hotel and World Trade Center, Boston. The topic is: “FDA Perspective Surrounding eSource Guidance”. Our colleague Darlene Kalinowski, Senior Manager Regional Clinical Operations at Bristol Myers Squibb will be chairing the session. Download the latest conference brochure to learn more. You may also want to download the latest event podcast from Craig Lipset, Head of Clinical Innovations for Worldwide R&D at Pfizer. Please let us know if you are attending.

 

You may register for the event with Target Health’s special discount of 25% off the standard registration rate. Register online, call 888.670.8200, or email register@iirusa.com. Be sure to use Priority Code XP1609SPJM. This event is part of the Clinical Business Expo, a unique opportunity to network across the clinical development continuum as six events convene with over 200 leading expert speakers, 600+ executive attendees and 50 exhibitors.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com

An Apple or Pear a Day May Keep Strokes Away

 

 

Apples and pears may keep strokes away and that’s the conclusion of a Dutch study published in Stroke: Journal of the American Heart Association in which researchers found that eating a lot of fruits and vegetables with 1) ___ flesh may protect against stroke. While previous studies have linked high consumption of fruits and vegetables with lower stroke 2) ___, the researchers’ prospective work is the first to examine associations of fruits and vegetable color groups with stroke.

 

The color of the edible portion of fruits and 3) ___ reflects the presence of beneficial phytochemicals such as carotenoids and flavonoids.

 

Researchers examined the link between fruits and vegetable color group consumption with 10-year stroke incidence in a population-based study of 20,069 adults, with an average age of 41. The participants were free of 4) ___ diseases at the start of the study and completed a 178-item food frequency questionnaire for the previous year.

 

Fruits and vegetables were classified in four color groups:

Green, including dark leafy vegetables, cabbages and lettuces

Orange/Yellow, which were mostly citrus fruits

Red/Purple, which were mostly red vegetables

White, of which 55% were apples and pears

 

During 10 years of follow-up, 233 strokes were documented. Green, orange/yellow and red/purple fruits and vegetables weren’t related to stroke. However, the risk of stroke incidence was 52% lower for people with a high intake of white fruits and vegetables compared to people with a 5) ___ intake. Each 25 gram per day increase in white 6) ___ and vegetable consumption was associated with a 9% lower risk of stroke. An average apple is 120 grams.

 

“To prevent stroke, it may be useful to consume considerable amounts of white fruits and vegetables,” said Linda M. Oude Griep, M.Sc., lead author of the study and a postdoctoral fellow in human nutrition at Wageningen University in the Netherlands. “For example, eating one apple a 7) ___ is an easy way to increase white fruits and vegetable intake. “However, other fruits and vegetable color groups may protect against other chronic 8) ___. Therefore, it remains of importance to consume a lot of fruits and vegetables.”

 

Apples and pears are high in dietary 9) ___ and a flavonoid called quercetin. In the study, other foods in the white category were bananas, cauliflower, chicory and cucumber. Potatoes were classified as a starch.

 

Previous research on the preventive health benefits of fruits and vegetables focused on the food’s unique nutritional value and characteristics, such as the edible part of the plant, color, botanical family and its ability to provide antioxidants. U.S. federal dietary guidelines include using color to assign nutritional value. The U.S. Preventive Health Services Taskforce recommends selecting each day vegetables from five subgroups: dark green, red/orange, legume, starchy and other vegetables.

 

Before the results are adopted into everyday practice, the findings should be confirmed through additional research, Oude Griep said. “It may be too early for physicians to advise 10) ___ to change their dietary habits based on these initial findings,” she said. An accompanying editorial, notes that the finding should be interpreted with caution because food frequency questionnaires may not be reliable.

 

In addition, “the observed reduction in stroke risk might further be due to a generally healthier lifestyle of individuals consuming a diet rich in fruits and vegetables,” writes Heike Wersching, M.D., M.Sc., of Institute of Epidemiology and Social Medicine at the University of Münster, in Germany.

 

ANSWERS: 1) white; 2) risk; 3) vegetables; 4) cardiovascular; 5) low; 6) fruits; 7) day; 8) diseases; 9) fiber; 10) patients

Antibiotic Resistance is Ancient

 

 

Canadian scientists have discovered bacterial antibiotic resistance genes in soil frozen for over 30,000 years. Working at a site close to Dawson City in Yukon, Vanessa D’Costa and her colleagues drilled 6 meters into the permafrost to recover core samples from soils aged by carbon dating to coincide with a time when mammoths and bison roamed the area. Using sensitive genetic techniques, the team was able to recover from the samples DNA sequences of trees, animals and microorganisms.

 

Focusing on the bacteria, they were able to identify the genetic signatures of a range of microbial species, including genes known to confer resistance to several classes of modern day antibiotics. The VanX gene that enables bugs to evade vancomycin was one, the TetM gene, which provides tetracycline resistance also turned up, as did the beta-lactamase gene that breaks down penicillins.

 

The scientists ruled out contamination of their core samples by contemporary organisms by first spraying their drilling equipment with a strain of E. coli into which a glowing-green jellyfish gene had been inserted. By looking at the levels of this gene amongst the DNA they recovered from the cores they could gauge the level of contamination, which was extremely low. To confirm that the ancient anti-antibiotic genes were functional, the VanX gene recovered from the cores was inserted into a strain of laboratory-grown E. coli bacteria, which made the gene product. This was further tested to confirm that it behaves identically to the VanX resistance genes found in hospitals today.

 

So, far from being a new phenomenon that has emerged only in the last 80 years over which antibiotics have become mainstream, antibiotic resistance is in fact much older. As the researchers say in their paper in the journal Nature, “This work firmly establishes that antibiotic resistance genes predate our use of antibiotics and offers the first direct evidence that antibiotic resistance is an ancient, naturally-occurring phenomenon widespread in the environment.”

 

This is because, after all, the antibiotics we use in hospitals today are largely “borrowed” from other microbes, which normally make these chemicals to protect themselves. Naturally, other bugs have evolved defense measures in the form of resistance genes. This predicts that new antibiotics will select for pre-existing resistance determinants that have been circulating within the microbial pangenome for millennia. The reality must be a guiding principle in our stewardship of existing and new antibiotics. Reference: doi:10.1038/nature10388

Baseline Serum Adipokine Levels Predict Radiographic Progression in Early Rheumatoid Arthritis

 

Adipose tissue can secrete soluble mediators (adipokines) with potent immune regulatory functions. Some adipokines have been previously associated with radiographic damage in patients with rheumatoid arthritis (RA). As a result, a study published in Arthritis & Rheumatism (2011;63:2567–2574), investigated the capacity of baseline adipokine levels to predict radiographic progression over a period of 4 years. In addition, the study evaluated the contribution of adipokines relative to that of other known risk factors, such as anti-cyclic citrullinated peptide (anti-CCP) antibodies.

 

For the study, serum concentrations of leptin, visfatin, resistin, adiponectin, adipsin, tumor necrosis factor α (TNFalpha), and interleukin-6 (IL-6) were determined in serum samples obtained at baseline from 253 patients with RA from the Early Arthritis Cohort. The association between levels of these adipokines and radiographic progression was determined using a multivariate normal regression model correcting for age, gender, treatment strategy, body mass index (BMI), and the presence of anti-CCP antibodies.

 

Results showed that levels of IL-6, TNF alpha, visfatin, and adiponectin were positively associated with radiographic progression over 4 years. This association was independent of BMI. However, only adiponectin levels remained significantly associated with radiographic progression when the model was corrected for the presence of anti-CCP antibodies, whereas a trend was observed for IL-6. The association of both TNF alpha and visfatin with radiographic damage disappeared after correction for the presence of anti-CCP antibodies, which is consistent with the fact that the levels of both cytokines correlated significantly with anti-CCP antibody levels in these patients.

 

According to the authors, the results indicate that adipokines are predictors of radiographic progression in RA, possibly through distinct underlying biologic mechanisms.

Effects of Mindfulness Training on the Severity of Irritable Bowel Syndrome in Women

 

Mindfulness-based cognitive therapy (MBCT) is psychological therapy which blends features of cognitive therapy with mindfulness techniques of Buddhism. MBCT involves accepting thoughts and feelings without judgment rather than trying to push them out of consciousness, with a goal of correcting cognitive distortions. The aim of MBCT is not directly to relaxation or happiness in themselves, but rather, a “freedom from the tendency to get drawn into automatic reactions to thoughts, feelings, and events”. MBCT programs usually consist of eight weekly two-hour classes with weekly assignments to be done outside of session. The aim of the program is to enhance awareness so clients are able to respond to things instead of react to them

 

According to an article published in the American Journal of Gastroenterology (2011; 106:1678-1688), a prospective, randomized controlled trial was performed to explore the feasibility and efficacy of a group program of mindfulness training for women with irritable bowel syndrome (IBS). For the study, 75 female IBS patients were randomly assigned to eight weekly and one half-day intensive sessions of either mindfulness group (MG) training or a support group (SG). Participants completed the IBS severity scale (primary outcome), IBS-quality of life, brief symptom inventory-18, visceral sensitivity index, treatment credibility scale, and five-facet mindfulness questionnaire before and after treatment and at 3-month follow-up.

 

Results showed that women in the MG showed greater reductions in IBS symptom severity immediately after training (26.4% vs. 6.2% reduction; P=0.006) and at 3-month follow-up (38.2% vs. 11.8%; P=0.001) relative to SG. Changes in quality of life, psychological distress, and visceral anxiety were not significantly different between groups immediately after treatment, but evidenced significantly greater improvements in the MG than in the SG at the 3-month follow-up. Mindfulness scores increased significantly more in the MG after treatment, confirming effective learning of mindfulness skills. Participants’ ratings of the credibility of their assigned interventions, measured after the first group session, were not different between groups.

 

According to the authors, the study demonstrated that mindfulness training has a substantial therapeutic effect on bowel symptom severity, improves health-related quality of life, and reduces distress and that the beneficial effects persist for at least 3 months after group training.

Longitudinal Evidence That Fatherhood Decreases Testosterone in Human Males

 

 

In species in which males care for young, testosterone (T) is often high during mating periods but then declines during caregiving of resulting offspring. This model may apply to human males as well, but past human studies of T and fatherhood have been cross-sectional, making it unclear whether fatherhood suppresses T or if men with lower T are more likely to become fathers. As a result, a study published in the Proceeding of the National Academy of Sciences (PNAS; 12 September 2011) evaluated a large representative population of single non-fathers at baseline (21.5 ± 0.3 y) in the Philippines (n = 624), and showed that those with high waking T were more likely to become partnered fathers by the time of follow-up 4.5 y later (P < 0.05). The study then showed that men who became partnered fathers then experienced large declines in waking (median: −26%) and evening (median: −34%) T, which were significantly greater than declines in single nonfathers (P < 0.001). Consistent with the hypothesis that child interaction suppresses T, fathers reporting 3 h or more of daily childcare had lower T at follow-up compared with fathers not involved in care (P < 0.05). Using longitudinal data, these findings show that T and reproductive strategy have bidirectional relationships in human males, with high T predicting subsequent mating success but then declining rapidly after men become fathers. According to the authors, the findings suggest that T mediates tradeoffs between mating and parenting in humans, as seen in other species in which fathers care for young.

TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.

 

 

Changes in Drug Utilization during a Gap in Insurance Coverage: An Examination of the Medicare Part D Coverage Gap

 

 

What is the impact on the public health and overall healthcare costs when people stop taking their medications?

 

While the US government’s Medicare Part D drug insurance benefit expanded elderly citizens’ access to drugs, it also included a controversial period called the “coverage gap” during which beneficiaries are fully responsible for drug costs. As a result, a study published in PloS Medicine (August 2011), was performed to examine the impact of entering the coverage gap on drug discontinuation, switching to another drug for the same indication, and drug adherence.

 

The study followed 663,850 Medicare beneficiaries enrolled in Part D or retiree drug plans with prescription and health claims in 2006 and/or 2007 to determine who reached the gap spending threshold, n = 217,131 (33%). The study compared drug discontinuation and switching rates in selected drug classes after reaching the threshold between those who had no financial assistance during the coverage gap (exposed) versus those with financial assistance (unexposed). Results showed that exposed beneficiaries were twice as likely to discontinue and less likely to switch a drug after reaching the threshold.

 

According to the authors, a lack of financial assistance after reaching the gap spending threshold was associated with a doubling in discontinuing essential medications but not switching drugs, and that blunt cost-containment features such as the coverage gap have an adverse impact on drug utilization that may conceivably affect health outcomes.

 

 

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Joyce Hays, CEO
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