9 December 2007
I. WHAT'S NEW?
Abstract Accepted for DIA 23rd Annual “Data Management in Transition” Conference
Job Opportunities at Target Health
II. QUIZ - (Fill In The Blanks)
Breath Test Detects Early Stages of Lung Cancer
III. HISTORY OF MEDICINE
Photoluminescence Therapy
IV. PUBLIC HEALTH
Childhood Obesity and Risk of CHD
V. EENT
Steroids and Antibiotics Not Effective in Acute Sinusitis
VI. CARDIOLOGY
Solid Outcomes With Home-Based vs. Office-Based BP Monitoring
VII.
REGULATORY AFFAIRS
Get Your Email Alerts From FDA
VIII. TARGET HEALTH
II. QUIZ
(Fill
In The Blanks)
Breath Test Detects Early Stages of Lung Cancer
Lead researcher Dr. Peter Mazzone and his team from the Cleveland Clinic have developed a breath test that can successfully pick up lung cancer with "moderate accuracy" even in the early stages. This breath test could revolutionize the way cancer is 1) ___ and potentially save lives. The test comprises a chemical 2) ___ sensor, which detects tiny changes in the unique 3) ___ signature of the breath of people with lung cancer. Metabolic changes in lung cancer cells cause changes in the production and processing of volatile organic 4) ___. Lung cancer cells give off chemicals, called volatile 5) ___ compounds or VOCs, which are then exhaled. The researchers used the color sensor to test the breath of 122 people with different types of 6) ___ disease, and 21 healthy people. Included in the group with respiratory illness were 49 people with small cell lung cancer at various stages of development. The research team used the sensor results from 70% of the study participants to develop a predictive model, the accuracy of which was then tested on the remaining 30%. The results showed that the test was able to predict, accurately, the presence of cancer in just under three out of four of those with lung cancer. The results were not affected by age, gender, or stage of disease. Other approaches to breath testing have been used, including, gas 7) ___ and mass spectrometry, both of which require a great deal of expertise to use, plus, both are very expensive. According to the authors, as cancer is often silent in its early stages and symptoms are often not specific, it is often difficult to pick up the disease at a stage when it could be treated effectively. Diagnosis is often, therefore, only made when the disease is 8) ___. Ultimately, this line of investigation could lead to an inexpensive, non-invasive screening or diagnostic test for lung cancer.IV. PUBLIC HEALTH
Childhood Obesity and Risk of CHD
The worldwide epidemic of childhood obesity is progressing at an alarming rate. Risk factors for coronary heart disease (CHD) are already identifiable in overweight children. As a result, a study published in the New England Journal of Medicine (2007;357:2329-2337) was performed to evaluate the the long-term effects of excess childhood weight on CHD. The study investigated the association between body-mass index (BMI) in childhood (7 through 13 years of age) and CHD in adulthood (25 years of age or older), with and without adjustment for birth weight. The subjects were a cohort of 276,835 Danish schoolchildren for whom measurements of height and weight were available. CHD events were ascertained by linkage to national registers. Cox regression analyses were performed. Results showed that in 5,063,622 person-years of follow-up, 10,235 men and 4,318 women for whom childhood BMI data were available received a diagnosis of CHD or died of CHD as adults. The risk of any CHD event, a nonfatal event, and a fatal event among adults was positively associated with BMI at 7 to 13 years of age for boys and 10 to 13 years of age for girls. The associations were linear for each age, and the risk increased across the entire BMI distribution. Furthermore, the risk increased as the age of the child increased. Adjustment for birth weight strengthened the results. According to the authors, higher BMI during childhood is associated with an increased risk of CHD in adulthood and that the associations are stronger in boys than in girls and increase with the age of the child in both genders. The findings also suggest that as children are becoming heavier worldwide, greater numbers of them are at risk of having CHD in adulthood.V. EENT
Steroids and Antibiotics Not Effective in Acute Sinusitis
Acute sinusitis is a common clinical problem that usually results in a prescription for antibiotics but the role of antibiotics is debated. Anti-inflammatory drugs such as topical steroids may be beneficial but are under-researched. As a result, a study published in the Journal of the American Medical Association (2007;298:2487-2496) was performed to determine the effectiveness of amoxicillin and topical budesonide in acute maxillary sinusitis. The investigation was a double-blind, randomized, placebo-controlled factorial trial of 240 adults (aged 16 years) with acute nonrecurrent sinusitis (inclusion criteria included 2 diagnostic criteria: purulent rhinorrhea with unilateral predominance, local pain with unilateral predominance, purulent rhinorrhea bilateral, presence of pus in the nasal cavity). Patients were randomized to 1 of 4 treatment groups: antibiotic and nasal steroid; placebo antibiotic and nasal steroid; antibiotic and placebo nasal steroid; placebo antibiotic and placebo nasal steroid. Active drugs included a dose of 500 mg of amoxicillin 3 times per day for 7 days and 200 µg of budesonide in each nostril once per day for 10 days. The main outcome measures were the proportion of patients clinically cured at day 10 using patient symptom diaries, and the duration and severity of symptoms. Results showed The proportions of patients with symptoms lasting 10 or more days were 29% for amoxicillin vs 33.6% for no amoxicillin. The proportions of patients with symptoms lasting 10 or more days were 31.4% for topical budesonide vs 31.4% for no budesonide. Secondary analysis suggested that nasal steroids were significantly more effective in patients with less severe symptoms at baseline. It was concluded that neither an antibiotic nor a topical steroid alone or in combination was effective as a treatment for acute sinusitis in the primary care setting.VI. CARDIOLOGY
Solid Outcomes With Home-Based vs. Office-Based BP Monitoring
It is still uncertain whether one can safely base treatment decisions on self-measurement of blood pressure. As a result, a study published in Hypertension (2007;50:1019-1025) was performed to evaluate whether antihypertensive treatment based on self-measurement of blood pressure leads to the use of less medication without the loss of blood pressure control. The study randomly assigned 430 hypertensive patients to receive treatment either on the basis of self-measured pressures (n=216) or office pressures (OPs; n=214). During 1-year follow-up, blood pressure was measured by office measurement (10 visits), ambulatory monitoring (start and end of the study), and self-measurement (8 times, self-pressure group only). In addition, drug use, associated costs, and degree of target organ damage (echocardiography and microalbuminuria) were assessed. Results showed that the self-pressure group used less medication than the OP group (1.47 versus 2.48 drug steps; P<0.001) with lower costs ($3222 versus $4420 per 100 patients per month; P<0.001), but without significant differences in systolic and diastolic OP values (1.6/1.0 mm Hg), in changes in left ventricular mass index (–6.5 g/m2 versus –5.6 g/m2), or in median urinary microalbumin concentration (–1.7 versus –1.5 mg per 24 hours). Nevertheless, 24-hour ambulatory blood pressure values at the end of the trial were higher in the self-pressure than in the OP group: 125.9 versus 123.8 mm Hg (P<0.05) for systolic and 77.2 versus 76.1 mm Hg (P<0.05) for diastolic blood pressure. According to the authors, the data show that self-measurement leads to less medication use than office blood pressure measurement without leading to significant differences in OP values or target organ damage. However, ambulatory values, however, remain slightly elevated for the self-pressure group.VII. REGULATORY AFFAIRS
TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.Get Your Email Alerts From FDA
The FDA has announced a new e-mail service that alerts subscribers whenever information is updated on certain FDA Web pages. The service is free and available for a wide variety of FDA's Web pages, including food safety protection, medical product approvals and consumer health information. To receive e-mail alerts, subscribers need only click on the red envelope icon located on participating Web pages. Each e-mail update includes a direct link to the FDA Web page that has been updated. Powered by GovDelivery, a private sector e-mail subscription management system used by several other federal agencies, the service allows subscribers the flexibility to personalize the information most important to them. A full list of currently available topics can be found at www.fda.gov/emaillist.html).VIII. TARGET HEALTH
TARGET HEALTH INC. (www.targethealth.com) is a full service eCRO with full-time staff dedicated to all aspects of drug and device development. Areas of expertise include Regulatory Affairs, comprising, but not limited to, IND, IDE, NDA, PMA and 510(k) submissions, execution of Clinical Trials, Project Management, Biostatistics and Data Management, Web Trials, utilizing Target e*CRF®, our proprietary Internet-based Clinical Trial System, and Medical Writing. TARGET HEALTH's Pharmaceutical Advisory Dream Team assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.TARGET
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