4 November 2007
I. WHAT'S NEW?
FDA Audit
II. QUIZ - (Fill In The Blanks)
New Way To Predict Survival In Women With Lung Cancer
III. HISTORY OF MEDICINE
Public Health - Beginnings in Antiquity
IV. OPHTHALMOLOGY
Lutein and Zeaxanthin in the Diet Can Affect Progression of AMD
V. ORTHOPEDICS
Yearly Treatments Post Hip Surgery Affects Survival
VI. HIV AIDS
Treatment in Developing Countries is Effective
VII.
REGULATORY AFFAIRS
Buyer Beware of Imported Drugs
VIII. TARGET HEALTH
II. QUIZ
(Fill
In The Blanks)
New Way To Predict Survival In Women With Lung Cancer
UCLA researchers have linked higher levels of aromatase, an 1) ___ that naturally makes estradiol from testosterone, to more aggressive disease and lower survival rates in women over 65 with Stage 1 or 2 lung cancer. The discovery not only gives physicians a possible new tool to predict survival, but may also provide a target for therapy using aromatase 2) ___, already approved for the treatment of breast cancer. All indications suggest that aromatase is a very powerful prognostic marker that lets us predict which patients have a higher likelihood of prolonged survival versus 3) ___ from lung cancer. If doctors know that a woman has a higher probability of longer-term 4) ___, they may choose a more strategic course of action, compared to a woman with a more aggressive form of lung cancer, where doctors might choose a more aggressive course of therapy. Another notable finding from this study is that survival can be predicted at a relatively early stage of the 5) ___, when there are more treatment options. Based on research done at Jonsson Cancer Center labs, scientists discovered that 6) ___ played a role in lung cancer growth, much as it does in breast cancer. In animal models, researchers showed that either estradiol or aromatase triggered the growth of human lung cancer tumors. They then looked retrospectively at lung cancer tumor samples from more than 750 men and women seen at UCLA and the M.D. Anderson Cancer Center using a novel high-throughput technology called tissue 7) ___ .Aromatase levels were measured and correlated with disease aggression and survival rates. Researchers found that in women 65 and over, higher 8) ___ levels were associated with more aggressive disease and a greater risk of death. The study, conducted as part of the Specialized Program of Research Excellence (SPORE) in lung cancer at UCLA, appears in the Nov. 1 issue of the peer-reviewed journal Cancer Research.IV. OPHTHALMOLOGY
Lutein and Zeaxanthin in the Diet Can Affect Progression of AMD
Lutein and zeaxanthin are two of the most abundant carotenoids in the North American diet. Unlike beta-carotene, alpha-carotene and beta-cryptoxanthin, these two carotenoids are not considered to be "provitamin A" compounds, as they are not converted in the body into retinol, an active form of vitamin A. Food sources of lutein and zeaxanthin include eggs, kale, spinach, turnip greens, collard greens, romaine lettuce, broccoli, zucchini, corn, garden peas and Brussels sprouts. There are claims in the dietary supplement literature that lutein and zeaxanthin have a positive effect on the progression of age-related macular degeneration (AMD). As a result, a study published in the Archives of Ophthalmology (2007;125:1225-1232) was performed to evaluate the relationship of dietary carotenoids, vitamin A, alpha-tocopherol, and vitamin C with prevalent age-related macular degeneration (AMD) in the Age-Related Eye Disease Study (AREDS). For the study, demographic, lifestyle, and medical characteristics were ascertained on 4,519 AREDS participants aged 60 to 80 years at enrollment. Stereoscopic color fundus photographs were used to categorize participants into 4 AMD severity groups and a control group (participants with < 15 small drusen). Drusen are the tiny orange or yellow dots among the retinal pigment epithelial cells (RPE). Nutrient intake was estimated from a self-administered semiquantitative food frequency questionnaire at enrollment. Results showed that, when the highest vs lowest intake levels dietary lutein and zeaxanthin were compared, their intake was inversely associated with neovascular AMD (odds ratio [OR], 0.65), geographic atrophy (end stage of the dry form) (OR, 0.45), and large or extensive intermediate drusen (OR, 0.73). Other nutrients were not independently related to AMD. It was concluded that higher dietary intake of lutein/zeaxanthin was independently associated with decreased likelihood of having neovascular AMD, geographic atrophy, and large or extensive intermediate drusen.V. ORTHOPEDICS
Yearly Treatments Post Hip Surgery Affects Survival
It is well known that mortality is increased after a hip fracture. As a result, a study published in the New England Journal of Medicine (2007; 357:1799-1809) was performed to evaluate yearly intravenous zoledronic acid (at a dose of 5 mg) in its ability to improve clinical outcomes after hip surgery. The investigation was a randomized, double-blind, placebo-controlled trial. Of the study participants, 1,065 patients were assigned to receive yearly intravenous zoledronic acid and 1,062 patients were assigned to receive placebo. The infusions were first administered within 90 days after surgical repair of a hip fracture. All patients (mean age, 74.5 years) received supplemental vitamin D and calcium. The median follow-up was 1.9 years. The primary end point was a new clinical fracture. Results showed that the rates of any new clinical fracture were 8.6% in the zoledronic acid group and 13.9% in the placebo group, representing a 35% risk reduction with zoledronic acid (P=0.001). The respective rates of a new clinical vertebral fracture were 1.7% and 3.8% (P=0.02), and the respective rates of new nonvertebral fractures were 7.6% and 10.7% (P=0.03). In the safety analysis, 9.6% of patients in the zoledronic acid group and 13.3% of patients in the placebo group (13.3%) died, a reduction of 28% in deaths from any cause in the zoledronic acid group (P=0.01). The most frequent adverse events in patients receiving zoledronic acid were pyrexia (fever) and myalgia (muscle pain), and bone and musculoskeletal pain. No cases of osteonecrosis of the jaw were reported, and no adverse effects on the healing of fractures were noted. The rates of renal and cardiovascular adverse events, including atrial fibrillation and stroke, were similar in the two groups. It was concluded that an annual infusion of zoledronic acid within 90 days after repair of a low-trauma hip fracture was associated with a reduction in the rate of new clinical fractures and with improved survival.VI. HIV AIDS
Treatment in Developing Countries is Effective
Increasing access to highly active antiretroviral therapy to reach all those in need in developing countries is slowly expanding to HIV-positive children, but documented experience remains limited. As a result, a study published in Pediatrics (2007;120:e1134-e1140) described the clinical, immunologic, and virologic outcomes of pediatric patients with >12 months of highly active antiretroviral therapy in 2 routine programs in Cambodia. For the study, between June 2003 and March 2005, 212 children who were younger than 13 years started highly active antiretroviral therapy. Most patients started a standard first-line regimen of lamivudine, stavudine, and nevirapine, using split adult fixed-dosage combinations. CD4 percentage and body weight were monitored routinely. In January 2006, a cross-sectional virologic analysis was conducted and genotype resistance testing was performed for patients with a detectable viral load. Mean age of the study participants was 6 years. Median CD4 percentage at baseline was 6 and survival was 92% at 12 months and 91% at 24 months. Thirteen patients died, and 4 were lost to follow-up. At the end of the study, a total of 81% of all patients had an undetectable viral load. Among the patients with a detectable viral load, most mutations were associated with resistance to lamivudine and non–nucleoside reverse-transcriptase inhibitor drugs. Five patients had developed extensive antiretroviral resistance and being an orphan was found to be a predictor of virologic failure. According to the authors, the study provided additional evidence of the effectiveness of integrating HIV/AIDS care with highly active antiretroviral therapy for children in a routine setting. The authors added that viral load monitoring and HIV genotyping are valuable tools for the clinical follow-up of the patients, and that orphans should receive careful follow-up and extra support.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.Buyer Beware of Imported Drugs
A yearlong FDA investigation into drugs mailed to the US from foreign countries suggests that consumers may be buying drugs online to avoid the need for a prescription from their physician. The FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet. The investigation found 88% of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Of the remaining products, some were dietary supplements, some were foreign products with labeling that was illegible or incomprehensible, and some were medications not available in the United States. More than half (53%) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the US to be generally cheaper than a comparable drug in Canada or Western Europe. In fact, approved generic versions of approximately half (47%) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online. These data are based on surveys conducted from September 2006 to August 2007 in international mail facilities and courier facilities across the country. At each city surveyed, a selection of parcels suspected by U.S. Customs and Border Protection of containing pharmaceuticals were stopped. FDA then recorded data on the contents of these parcels, before handling them in accordance with its usual procedures. According to FDA, in general, a Web site can appear legitimate, but in fact be a front for an illegal operation. FDA urges consumers to beware of unregulated Internet drug sellers, because many of their products might not contain the correct ingredients and could contain toxic substances. Several drugs found in this survey require special monitoring by physicians or other health care professionals for potential adverse events and to ensure their effectiveness. These include antibiotics, antidepressants, the blood thinner warfarin, and levothyroxine (a thyroid replacement hormone).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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