Science Weekly: Saving pandas, tigers and tortoises

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Are giant pandas really endangered? Glastonbury goes solar, the best physics on the web, tiger droppings, plus sounds from the Large Hadron Collider

Target Health and Ferring Pharmaceuticals Co-Presenting at CBI’s 4th Annual CTMS Meeting

Silvana Cappi Head of Biometrics at Ferring Pharmaceuticals and Dr. Jules T. Mitchel will be presenting a talk at CBI’s 4th Annual Clinical Trial Management Systems (CTMS), March 24-25, 2011, Crowne Plaza, in Philadelphia. The topic will be an “Analysis of a Decision Whether to Co-Develop a CTMS with an eCRO or to Buy an Existing Application.” You may be surprised by the outcome.

This is the only forum dedicated solely to discussion regarding CTMS systems and the program offers the unique opportunity for industry collaboration among various CTMS stakeholders. In addition to our presentation, the meeting will feature industry case studies and perspectives from Sanofi-Aventis, Merck & Co., Inc., Millennium: The Takeda Oncology Company and GlaxoSmithKline, to name a few. Thus the program offers a balanced perspective of the different types of CTMS systems utilized by the industry.

Featured session on “Analysis of the Decision Whether to Co-Develop a CTMS with an eCRO or to Buy an Existing Application”, provides the clinical operations and IT professional with insight into the development of a CTMS system that was not purchased off the shelf.

If you register by January 21, 2011 you will receive $300 off of your registration fee. Please visit the CBI website: www.cbinet.com/ctms or call: 339-298-2100 for more information or to register.

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. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

Pomegranate Juice Reduces Damage to Tissues, Inflammation and Infections

Studies in recent years have claimed multiple health benefits of pomegranate juice, including that it is a good source of 1) ___ and lowers both cholesterol and blood pressure, especially in diabetic and hypertensive patients. A preliminary study now suggests that it can ward off a number of complications in kidney disease patients on 2) ___, including the high morbidity rate due to infections and cardiovascular events, according to a paper being presented at the American Society of Nephrology’s 43rd Annual Meeting and Scientific Exposition in Denver, CO.

Batya Kristal, MD, FASN (Western Galilee Hospital, in Nahariya, Ruth & Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel), PhD candidate, Lilach Shema, and colleagues studied 101 dialysis patients who received either pomegranate juice or another 3) ___ drink at the beginning of each dialysis session, three times a week for one year.

Laboratory tests showed that patients who drank pomegranate juice experienced reduced 4) ___ and the damage of oxidative stress caused by free radicals, was minimized. Furthermore, pomegranate juice drinkers were less likely to be hospitalized due to 5) ___. These findings support other studies that suggest pomegranate juice has potent antioxidant properties.

Recent analyses of data not included in this abstract, revealed that those who drank pomegranate juice also showed an improvement in cardiovascular risk factors, such as reduced blood 6) ___, improvement in lipid profile and fewer cardiovascular events, suggesting that they had better heart health. These results are in agreement with other studied populations and particularly important for hemodialysis patients, because most 7) ___ disease patients die either from cardiovascular-related causes or infections.

The authors say their findings suggest that drinking a controlled amount of pomegranate juice with a safe and monitored content of potassium may help reduce the complications that often occur in dialysis patients. It is important to consider the risk involved in potassium overload, especially in chronic kidney disease (CKD) patients with dietary 8) ___ restriction.

“Considering the expected epidemic of CKD, or 9) __ __ __, in the next decade, further clinical trials using pomegranate juice aimed at reducing the high cardiovascular morbidity of CKD patients and their deterioration to end-stage renal disease should be conducted,” said Dr. Kristal.

ANSWERS

 

1) antioxidants; 2) dialysis; 3) placebo; 4) inflammation; 5) infections; 6) pressure; 7) kidney; 8) potassium; 9) Chronic Kidney Disease

The Microscope

Jannsen (1580-1638) invented the simple compound microscope

During the 1st century CE (year 100), glass had been invented and the Romans were looking through the glass and testing it. The Romans experimented with different shapes of clear glass and one of their samples was thick in the middle and thin on the edges. They discovered that if you held one of these “lenses” over an object, the object would look larger.

Someone also discovered that you can focus the rays of the sun with one of these special “glasses” and start a fire. These early lenses were called magnifiers or burning glasses. The word lens by the way, is derived from the latin word lentil, as they were named because they resembled the shape of a lentil bean (look up lens in a dictionary). These lenses were not used much until the end of the 13th century when spectacle makers were producing lenses to be worn as glasses.

The early simple “microscopes” which were really only magnifying glasses had one power, usually about 6X – 10X . One thing that was very common and interesting to look at was fleas and other tiny insects. These early magnifiers were hence called “flea glasses”. 

Sometime about the year 1590, two Dutch spectacle makers, Zaccharias Janssen and his father Hans started experimenting with these lenses. They put several lenses in a tube and made a very important discovery. The object near the end of the tube appeared to be greatly enlarged, much larger than any simple magnifying glass could achieve by itself! They had just invented the compound microscope (which is a microscope that uses two or more lenses).

Galileo heard of their experiments and started experimenting on his own. He described the principles of lenses and light rays and improved both the microscope and telescope. He added a focusing device to his microscope and of course went on to explore the heavens with his telescopes.

Anthony Leeuwenhoek of Holland became very interested in lenses while working with magnifying glasses in a dry goods store. He used the magnifying glass to count threads in woven cloth. He became so interested that he learned how to make lenses. By grinding and polishing, he was able to make small lenses with great curvatures. These rounder lenses produced greater magnification, and his microscopes were able to magnify up to 270X!

Anthony Leeuwenhoek became more involved in science and with his new improved microscope was able to see things that no man had ever seen before. He saw bacteria, yeast, blood cells and many tiny animals swimming about in a drop of water. From his great contributions, many discoveries and research papers, Anthony Leeuwenhoek (1632-1723) has since been called the “Father of Microscopy”.

Robert Hooke, an Englishman (who is sometimes called the “English Father of Microscopy”), also spent much of his life working with microscopes and improved their design and capabilities. Little was done to improve the microscope until the middle of the 19th century when great strides were made and quality instruments like today’s electron microscope emerged.

GENOMICS

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Effect of VX-770 in Persons with Cystic Fibrosis and the G551D-CFTR Mutation

Congratulations to our friends and colleagues at Vertex Pharmaceuticals.

According to an article published in the New England Journal of Medicine a new approach has been identified in the treatment of cystic fibrosis that involves improving the function of mutant cystic fibrosis transmembrane conductance regulator (CFTR). VX-770, a CFTR potentiator, has previously been shown to increase the activity of wild-type and defective cell-surface CFTR in vitro.

The study randomly assigned 39 adults with cystic fibrosis and at least one G551D-CFTR allele to receive oral VX-770 every 12 hours at a dose of 25, 75, or 150 mg or placebo for 14 days (in part 1 of the study) or VX-770 every 12 hours at a dose of 150 or 250 mg or placebo for 28 days (in part 2 of the study).

Results showed that at day 28, in the group of subjects who received 150 mg of VX-770, the median change in the nasal potential difference (in response to the administration of a chloride-free isoproterenol solution) from baseline was -3.5 mV (P=0.02 for the within-subject comparison; P=0.13 vs. placebo). The median change in the level of sweat chloride was -59.5 mmol per liter (P=0.008 within-subject; P=0.02 vs. placebo).

The median change from baseline in the percent of predicted forced expiratory volume in 1 second was 8.7% (; P=0.008 for the within-subject comparison, P=0.56 vs. placebo). None of the subjects withdrew from the study. Six severe adverse events occurred in two subjects (diffuse macular rash in one subject and five incidents of elevated blood and urine glucose levels in one subject with diabetes). All severe adverse events resolved without the discontinuation of VX-770.

According to the authors, the study showed that VX-770 was associated with within-subject improvements in CFTR and lung function and that the findings provide support for further studies of pharmacologic potentiation of CFTR as a means to treat cystic fibrosis.

Depression Is Associated With Increased Mortality 10 Years After Coronary Artery Bypass Surgery

Although many studies have examined the relationship of depression and mortality in patients with myocardial infarction, there is less understanding of the relationship between depression and long-term mortality after coronary artery bypass graft (CABG) surgery. As a result, a study published in Psychosomatic Medicine (2010;72:874-881) was performed to determine if depression is independently associated with cardiac and all-cause mortality 10 years after CABG surgery.

The study collected data on 309 patients hospitalized after CABG surgery. Before discharge, patients were assessed for depression using the Diagnostic Interview Schedule and the Beck Depression Inventory (BDI). Subsequently, mortality data were obtained from the National Center for Health Statistics and supplemented with phone interviews.

Results showed that 63 (20%) patients met modified Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for major depressive disorder (MDD) and 87 (28%) had BDI scores of 10, indicating elevated depressive symptoms. Time-to-event or last follow-up phone contact ranged from 9 days to 11.5 years (median, 9.3 years). The overall mortality rate was 37.9%, with 20.1% due to cardiac causes.

Age, EF, and diabetes predicted all-cause mortality, but MDD did not. Cox proportional hazard modeling showed that age, left ventricular ejection fraction (EF) and MDD were independent predictors of cardiac mortality. The BDI and the cognitive-affective symptoms subset of BDI symptoms were also predictors of cardiac mortality.

According to the authors, depression, assessed both in structured interview and by BDI, was significantly associated with elevated cardiac mortality 10 years after CABG surgery.

Adoption, Non-Adoption, and Abandonment of a Personal Electronic Health Record: Case Study of Healthspace

According to an article published in the British Medical Journal (2010; 341:c5814), a study was performed to evaluate the policy making process, implementation by National Health Service (NHS) organizations, and patients’ and carers’ experiences of efforts to introduce an internet accessible personal electronic health record (HealthSpace) in a public sector healthcare system.

Between 2007 and October 2010, 172,950 people opened a basic HealthSpace account. Of those who were invited to open an advanced account only 2,913 (0.13% of those invited) actually open the account, compared with 5-10% of the population anticipated in the original business case. Overall, patients perceived HealthSpace as neither useful nor easy to use and its functionality aligned poorly with their expectations and self management practices. Those who used email-style messaging were positive about its benefits, but enthusiasm beyond three early adopter clinicians was low, and fewer than 100 of 30,000 patients expressed interest. Policy makers’ hopes that “deploying” HealthSpace would lead to empowered patients, personalized care, lower NHS costs, better data quality, and improved health literacy were not realized over the three year evaluation period.

According to the authors, unless personal electronic health records align closely with people’s attitudes, self management practices, identified information needs, and the wider care package (including organizational routines and incentive structures for clinicians), the risk that they will be abandoned or not adopted at all is substantial. Conceptualizing such records dynamically (as components of a socio-technical network) rather than statically (as containers for data) and employing user centered design techniques might improve their chances of adoption and use. The findings raise questions about how eHealth programmes in England are developed and approved at policy level.

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

FDA Approves New Treatment Option For Late–tage Breast Cancer

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.

The FDA has approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease. Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven’s safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.

The study was designed to measure the length of time from when this treatment started until a patient’s death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.

The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.

Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late-stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

For more information about our expertise in Medical Affairs, contact Dr. Mark L. Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.