(Complimentary Newsletter from Target Health Inc.)

[Home] [Target e*CRO] [Target e*CRF] [Publications] [Press Release] [Advisors] [FDA Process] [Advertising]

17 July 2006

I.  WHAT'S NEW?
   NDA Approved in Canada Which Used Target e*CRF®
II.  QUIZ (Fill  In The Blanks)
   Coffee Could Help Keep Diabetes Away
III.  HISTORY OF MEDICINE
   Dr. John Cropper - Malaria Researcher in Palestine
IV. ONCOLOGY
   Weight Gain and Breast Cancer Risk
V. WOMEN'S HEALTH
   Healthy Lifestyle and Stroke-Risk in Women
VI. PEDIATRICS
   Arthritis and Kawasaki Disease
VII. CARDIOLOGY
   Genetic Factors in Heart Failure
VIII. FDA
   3-Drug Cocktail Approved for HIV
IX. Target Health Inc.

I. WHAT'S NEW

NDA Approved in Canada Which Used Target e*CRF®

Target Health Inc. is pleased to announce that one of our clients, Ferring Canada, has received Notice of Compliance (marketing clearance) for Menopur for the treatment of Infertility. For this global program, Target e*CRF® , Target Health’s Internet-based Clinical Trial/EDC system was used for data management.  This is the 2nd approval in Canada which used Target e*CRF®.  For this program, Target Health also did the statistical analyses and provided regulatory consultations.  To date, 2 NDAs and 1 PMA have been approved in the US which used Target e*CRF®.  It is anticipated that another PMA and NDA will be submitted in Q1 2007. For more information, please contact  Dr. Jules T. Mitchel.

II. QUIZ (Fill  In The Blanks)

Coffee Could Help Keep Diabetes Away 

Drinking lots of coffee cut women's risk of developing diabetes in an 11-year study, at the University of Minnesota, but it was the antioxidants, not the caffeine, in the brew that probably did the trick. In fact, diabetes risk was reduced most in participants who preferred 1) ___ coffee. The findings of this study, were published in Annals of Internal Medicine, on June 26, 2006. In the study, data was gathered, on nearly 29,000 older women who answered questions about risk factors for diabetes such as age, body mass index, physical activity and smoking. They also reported on their consumption of various foods and beverages, including regular and decaffeinated coffee. Women who drank more than 2) __ cups a day of any type of coffee were 22% less likely to develop type 2 3) ___, [adult onset], compared to those who avoided coffee. Diabetes risk dropped, by 33%, for those who drank more than six cups a day, of decaf. Coffee has many components, including powerful 4) ___ chemicals similar to those found in berries and grapes. Drinking four, five or more cups of coffee per day, might have very powerful antioxidant activity, that might be important for protecting the beta cells of the 5) ___ from oxidant damage. Beta cells produce 6) ___. Adult, or type 2, diabetes, occurs as the body slowly loses its ability to produce insulin. One interesting component of coffee is 7) ___ acid, which seems able to slow the absorption of 8) ___ by cells. Studies in rats found that the molecule lowered blood-sugar levels. Another reason to hope that chlorogenic acid is beneficial, is that it's abundant in both red wine and chocolate.

ANSWERS: 1) decaffeinated; 2) six; 3) diabetes; 4) antioxidant; 5) pancreas; 6) insulin; 7) chlorogenic; 8) sugar

III. HISTORY OF MEDICINE

Dr. John Cropper - Malaria Researcher in Palestine

On 21st November 1916, the Royal Navy Hospital ship Britannic (the sister ship of the Titanic) was torpedoed near the island of Kea in the Aegean Sea. Captain Dr. John Cropper, aged 52, was one of 30 people who drowned of the 1100 on board. Dr. Cropper was born in 1864, at Guisborough, England and obtained his medical degree from Cambridge University in 1891. In 1895, the Church Missionary Society sent him on a medical mission to Palestine where his prominent research was in the field of malaria - the most common and important disease in Palestine during that period. Dr. Cropper was the first in Palestine who routinely examined slides microscopically to correctly diagnosed the type of malaria. Dr. Cropper also suggested antimalarial measures aimed directly at the mosquito vector and paid attention to ecological aspects such as breeding places and the daily behavior of adult mosquitoes. Dr. Cropper noted the common antimalarial measurements of that time, such as covering of wells, planting of Eucalyptus trees to drain swamps and the routine use of quinine as a preventive medicine, were only partially effective. He suggested that the only effective measures must be aimed against the larval mosquitoes and he recommended the use of a sulfur compound in order to destroy the larvae. Only many years later were those observations recognized as being correct.

IV. ONCOLOGY

Weight Gain and Breast Cancer Risk

Endogenous hormones are a primary cause of breast cancer. Since adiposity affects circulating hormones, particularly in postmenopausal women, it may be a modifiable risk factor for breast cancer. As a result, a study published in the the Journal of the American Medical Association (2006;296:193-201), was performed to assess the associations of adult weight change since age 18 years and since menopause with the risk of breast cancer among postmenopausal women. The investigation was a prospective cohort study within the Nurses' Health Study. A total of 87,143 postmenopausal women, aged 30 to 55 years and free of cancer, were followed up for up to 26 years (1976-2002) to assess weight change since age 18 years. Weight change since menopause was assessed among 49,514 women who were followed up for up to 24 years. The main outcome measure was incidence of invasive breast cancer. During the study, 4,393 cases of invasive breast cancer were documented. Compared with those who maintained weight, women who gained 25.0 kg or more since age 18 years were at an increased risk of breast cancer (relative risk [RR], 1.45; P<.001 for trend), with a stronger association among women who have never taken postmenopausal hormones (RR,1.98). Compared with weight maintenance, women who gained 10.0 kg or more since menopause were at an increased risk of breast cancer (RR, 1.18; P=.002 for trend). Women who had never used postmenopausal hormones, lost 10.0 kg or more since menopause, and kept the weight off were at a lower risk than those who maintained weight (RR, 0.43; P=.01 for weight loss trend). Overall, 15.0% of breast cancer cases in this population may be attributable to weight gain of 2.0 kg or more since age 18 years and 4.4% (95% CI, 3.6%-5.5%) attributable to weight gain of 2.0 kg or more since menopause. Among those who did not use postmenopausal hormones, the population attributable risks are 24.2% for a weight gain since age 18 years and 7.6% for weight gain since menopause. According to the authors, these data suggest that weight gain during adult life, specifically since menopause, increases the risk of breast cancer among postmenopausal women, whereas weight loss after menopause is associated with a decreased risk of breast cancer. Thus, in addition to other known benefits of healthy weight, the results provide another reason for women approaching menopause to maintain or lose weight, as appropriate.

V. WOMEN'S HEALTH

Healthy Lifestyle and Stroke-Risk in Women    

Healthy lifestyle has been associated with decreased risk of coronary heart disease. In contrast, little is known about its association with stroke risk. As a result, an article published in the Archives of Internal Medicine (2006;166:1403-1409) was designED to evaluate the effect of lifestyle and stroke risk in women. The investigation was a prospective cohort study among 37,636 women 45 years or older participating in the Women's Health Study. Stroke was self-reported and confirmed by means of medical record review. Self-reported lifestyle factors included: smoking, alcohol consumption, exercise, body mass index, and diet. The health index was calculated from these variables by assigning scores from 0 to 4 to the respective variable categories, with a higher score indicating healthier behavior. Healthy behavior was defined as never smoking, alcohol consumption between 4 and 10.5 drinks per week, exercise 4 or more times per week, body mass index (calculated as weight in kilograms divided by the square of height in meters) less than 22, and a diet high in cereal fiber, folate, and omega-3 fatty acids, with a high ratio of polyunsaturated to saturated fat, and low in trans fat and glycemic load. Results showed that during 10 years of follow-up, there were 450 strokes (356 ischemic, 90 hemorrhagic, and 4 undefined). Compared with participants with 0 to 4 health index points (4.3%), women with 17 to 20 health index points (4.7%) had multivariable-adjusted hazard ratios of 0.45 (P<.001 for trend) for total stroke, 0.29 (P<.001 for trend) for ischemic stroke, and 1.27 (P = .62 for trend) for hemorrhagic stroke. According to the authors, in apparently healthy women, a healthy lifestyle consisting of abstinence from smoking, low body mass index, moderate alcohol consumption, regular exercise, and healthy diet was associated with a significantly reduced risk of total and ischemic stroke but not of hemorrhagic stroke. The authors added that the findings underscore the importance of healthy behaviors in the prevention of stroke.

VI.  PEDIATRICS

Arthritis and Kawasaki Disease  

Kawasaki disease is a children's illness. It's also known as Kawasaki syndrome or mucocutaneous lymph node syndrome. Symptoms include: fever; skin rash; bloodshot eyes; swollen lymph nodes; heart problems; joint problems. About 80% of the people with Kawasaki disease are under age five. Children over age eight are rarely affected. The disease occurs more often among boys (over 60%) and among those of Asian ancestry. Over 4,000 cases of Kawasaki disease are diagnosed annually in the United States. Less than 1% of those who get it die. According to a study published in the Journal of Pediatrics (2006; 148:800-805), a study was performed to define the prevalence, pattern, and clinical course of arthritis presenting at the time of diagnosis of Kawasaki disease. The investigation was a single-center, retrospective study of 414 consecutive patients diagnosed with Kawasaki disease between January 1997 and December 2002. Standardized clinical assessments, laboratory and imaging test results, and treatment regimens were reviewed. The clinical, laboratory, treatment response, and coronary outcome data were analyzed for children with and without arthritis. Results showed that the prevalence of arthritis was 7.5% (31/414). In the 31 children with arthritis, 55% had oligoarticular involvement and 45% had polyarticular involvement. In both of these groups, the large joints were predominantly involved. Some 88% of the children with arthritis responded to standard intravenous immunoglobulin therapy for acute Kawasaki disease and did not require additional medications. The children with arthritis had significantly increased levels of inflammatory markers, but their demographical and clinical features were otherwise similar to those of the children without arthritis, including coronary outcome, with the same proportion (13%) of children from each group having coronary artery lesions. According to the authors, arthritis is a short-lived phenomenon included in the clinical spectrum of acute Kawasaki disease. Children with arthritis have evidence of increased systemic inflammation but otherwise share the same clinical features, response to treatment, and coronary outcomes as patients without arthritis.

VII. CARDIOLOGY

Genetic Factors in Heart Failure  

The association between heart failure in parents and the prevalence of left ventricular systolic dysfunction and the risk of heart failure in their offspring has not been investigated in a community-based setting. As a result, a study published in the New England Journal of Medicine (2006;355:138-147) was performed to examine the cross-sectional association of heart failure in parents with the prevalence of left ventricular systolic dysfunction, as well as left ventricular mass, internal dimensions, and wall thickness. The study included 1497 participants of the Framingham Offspring Study (mean age, 57 years; 819 women) who underwent routine echocardiography. The study also investigated prospectively whether heart failure in parents increased the risk of heart failure in 2214 offspring (mean age, 44 years; 1150 women). Study results showed that as compared with the 1039 participants whose parents did not have heart failure, the 458 participants in the cross-sectional cohort who had at least one parent with heart failure were more likely to have increased left ventricular mass (17.0% vs. 26.9%), left ventricular internal dimensions (18.6% vs. 23.4%), and left ventricular systolic dysfunction (3.1% vs. 5.7%) In the longitudinal cohort, heart failure developed in 90 offspring during follow-up (mean length of follow-up, 20 years). The age- and gender-adjusted 10-year incidence rates of heart failure were 2.72% among offspring with a parent with heart failure, as compared with 1.62% among those without a parent with heart failure. According to the authors, heart failure in parents is associated with an increased prevalence of left ventricular systolic dysfunction cross-sectionally and an elevated risk of heart failure longitudinally.

VIII. FDA

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.

3-Drug Cocktail Approved for HIV

There are more than a million people living with HIV and AIDS in the US and 40,000 new cases are reported each year. Currently, there are 28 FDA approved products in the US used in the treatment of HIV infection. Within the last two years, FDA has approved more than 20 treatments to be used as part of President's Emergency Plan for AIDS Relief program, a $15 billion dollar initiative to fight the international HIV/AIDS pandemic. PEPFAR is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children worldwide. Last week, FDA announced approval of Atripla Tablets, a fixed-dose combination of three widely-used antiretroviral drugs, in a single tablet taken once a day, alone or in combination with other antiretroviral products for the treatment of HIV-1 infection in adults. Atripla, the first one-pill, once-a-day product to treat HIV/AIDS, combines the active ingredients of Sustiva (efavirenz), Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate). Bristol-Myers Squibb and Gilead Sciences have formed a joint venture to commercialize Atripla in the United States. The collaboration is the first of its kind in the field of HIV/AIDS. In certain territories, Merck holds the rights to efavirenz. All three companies will work together to ensure the product is available to patients and physicians. Atripla will be available for use in the United States as a new product approved under a new drug application (NDA). This would allow the drug to be considered for purchase for use in 15 other countries included under the President's Emergency Plan for AIDS Relief (PEPFAR). HIV-1 affects people worldwide. Atripla was approved in under three months under FDA's fast track program. The manufacturer plans to make the drug available for purchase in the United States within 96 hours. The approval of Atripla comes as the result of an expedited review process outlined in a guidance by the FDA in May 2004. With today's approval, FDA will have approved seven co-packaged or fixed-dose combination products since the guidance was issued. FDA approved Sustiva in 1998, Viread in 2001 and Emtriva in 2003. In addition, the safety and effectiveness of the combination of these three drugs were shown in a 48 week clinical study with 244 HIV-1 infected adults receiving the drugs contained in Atripla. In this trial, 80 % of the participants achieved a marked reduction of the human immunodeficiency virus and a substantial increase in the number of healthy CD4 cells -- cells that fight against infection. The labeling of Atripla includes a boxed warning that the drug's use can cause lactic acidosis (buildup of lactic acid in the blood). In patients with chronic Hepatitis B infection, the discontinuation of the treatment with Atripla (which is not approved for this use) can result in severe flare-ups of Hepatitis B infection. Other potential serious adverse events reported for the use of Atripla's ingredients include serious liver toxicity, renal impairment and severe depression. The most common adverse events experienced by participants in the combination trial included headache, dizziness, abdominal pain, nausea, vomiting and rash.

For a copy of the guidance or more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

IX. TARGET HEALTH

TARGET HEALTH INC. (www.targethealth.com) is a full service e*CRO 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 (PADT) assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.

TARGET HEALTH INC.
261 Madison Avenue
24th Floor
New York, NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105
Target Health Ad
www.targethealth.com
Dr. Jules T. Mitchel, President
Ms Joyce Hays, CEO

©2006 Target Health Inc. All rights reserved