20 April 2008
I. WHAT'S NEW?
New Programs at Target Health
II. QUIZ - (Fill In The Blanks)
How/Where Fat Is Stored Predicts Disease Risk Better Than Weight
III. HISTORY OF MEDICINE
Origin of Health Insurance in the Western World
IV. PEDIATRICS
Risk Factors For Survival of Extremely Low Birth Weight Infants
V. CARDIOLOGY
The NIH DASH Diet Improved Cardiovascular Disease Outcomes
VI.
REGULATORY AFFAIRS
FDA Plans to Open China Office in May 2008
VII. TARGET HEALTH
New Programs at Target Health
Target Health is growing with new programs in the following areas:How/Where Fat Is Stored Predicts Disease Risk Better Than Weight
A new study in mice indicates that overeating, rather than the 1) ___ it causes, is the trigger for developing metabolic syndrome, a collection of heath risk factors that increases an individual's chances of developing insulin resistance, fatty liver, heart disease and type 2 diabetes. How and where the body stores excess, unused 2) ___ appears to matter most when determining a person's risk of developing metabolic syndrome, researchers at UT Southwestern Medical Center suggest. Most people today think that obesity itself causes metabolic syndrome. We're ingrained to think that obesity is the cause of all health problems, when in fact it is the spillover of fat into organs other than fat cells that damages these organs, such as the heart and the liver. Depositing fatty 3) ___ in fat cells where they belong, actually delays that harmful spillover. The study, is to be published in a future issue of the Proceedings of the National Academy of Sciences. It is among the first to suggest that weight gain is an early symptom of pre-metabolic syndrome, rather than a direct 4) ___. Obesity delays the onset of metabolic syndrome, but it doesn't prevent it. People who are obese or overweight are on the road to developing metabolic syndrome unless they stop overeating. Sooner or later, it will happen. Currently about 50 million Americans suffer from metabolic syndrome. The exact cause of metabolic syndrome is 5) ___, but obesity and lack of exercise have been considered to be the primary underlying contributors to its development. Several studies in Dallas have shown that overweight patients with metabolic syndrome have increased fat levels in their liver, heart and pancreas. Individuals with congenital generalized lipodystrophy -- a genetic condition in which people are born with no fat cells in which to store fat -- develop metabolic syndrome at an earlier age than people who are obese. They also develop more severe cases of 6) ___ syndrome earlier than their obese counterparts. The goal of this study was to determine whether an individual's capacity to store fat in fat cells plays a role in whether they develop metabolic syndrome and type 2 diabetes and at what point that occurs. For the study, the researchers compared mice genetically altered to prevent their fat cells from expanding when overfed to mice with no such protections against becoming obese. The normal mice got fat when overfed, but didn't develop signs of metabolic syndrome until about 7 weeks into the experiment, at about 12 weeks of age. The mice engineered to remain slim, however, enjoyed no such pre-diabetic honeymoon period. Some became seriously ill at 4 to 5 weeks of age and displayed evidence of severe heart problems and marked hyperglycemia by 10 weeks of age, a full 8 weeks before the normal mice displayed even minimal heart problems. The genetically altered mice also suffered devastating damage to heart cells and to the insulin-secreting cells in their pancreas. Mice engineered to stay slim got sick quicker because the extra calories were not stored in the 7) ___ cells, the one place in the body equipped to store fat. Instead, fat was stored in other tissues, mimicking what happens in people with congenital generalized lipodystrophy. Recognition of this should encourage physicians and obese patients to pursue more aggressive interventions before they develop metabolic 8) ___, rather than after the onset of disease, as is customary. Mice genetically engineered to be obese are at no more risk of developing metabolic syndrome than normal mice. It's not the amount of body fat, but where it is stored in the body that appears to matter most to health. It's better to put surplus calories in fat cells than in the rest of the body because fat cells are designed specifically for fat storage. You won't be as trim, but you'll be 9) ___.The study results also imply that any gene that impairs the ability to store fat in the fat cells likely predisposes an individual to metabolic syndrome and type 2 diabetes.IV. PEDIATRICS
Risk Factors For Survival of Extremely Low Birth Weight Infants
Extremely low birth weight infants, the smallest, most frail category of preterm infants, are born in the 22nd through the 25th week of pregnancy -- far earlier than the 40 weeks of a full term pregnancy. These infants make up about 1% of babies born in the US each year, or roughly 40,000 babies. Many die soon after birth, despite the best attempts to save them. Some survive and reach adulthood, relatively unaffected. The rest will experience some degree of life long disability, ranging from minor hearing loss to blindness, to cerebral palsy, to profound intellectual disability. Level III facilities are the most advanced of neonatal care facilities. They offer the highly specialized medical care that extremely low birth weight infants need to survive. In deciding the kind of care to provide to these infants, specialists at intensive care facilities traditionally have relied heavily on an infant's gestational age -- the week of pregnancy a premature infant is born. Gestational age is known to play a large role in the infant's survival. For this reason, in many facilities, intensive care is likely to be routinely given to infants born in the 25th week of pregnancy, whereas infants born in the 22nd week may be more likely to receive just comfort care where an infant's basic needs are provided for, but there are no painful medical procedures. According to an article published in the New England Journal of Medicine (2008;358:1672-1681), several factors have been identified that influence an extremely low birth weight infant's chances for survival and disability. To identify other factors that influenced survival and disability risk, the authors observed more than 4,000 extremely low birth weight infants in their network. In addition to gestational age, factors influencing survival and risk of disability consisted of: gender; birthweight; whether the baby was a single baby, or one of two or more infants born; and whether the baby's mother was given medication during pregnancy to prompt the development of the baby's lungs. Known as antenatal steroids, these drugs are typically given to women in premature labor, or who are at known risk for giving birth prematurely. The study involved only infants born at level III neonatal intensive care facilities. For this reason, the study findings may not apply to infants born at level I and level II facilities. For the study, researchers in the NICHD Neonatal Research Network observed 4,446 infants born at 22-25 weeks' gestational age at hospitals around the US. Using standardized measures of mental development, vision, and hearing, the study assessed the health status of surviving infants when the infants were from 18 to 22 months corrected age -- the age they would have been, had they been born full term. Results showed that 49% of the infants in the study had died, 21% lived and did not have a disability, while the remainder experienced some degree of disability. It was determined that infants were more likely to survive -- and more likely to survive without disability -- if they were of older gestational age, their mothers had been given corticosteroids, if they were female, were single born rather than part of a multiple birth, and been of a higher birthweight. Physicians and parents may access an online tool that generates statistics, based on the factors listed in this article.V. CARDIOLOGY
The NIH DASH Diet Improved Cardiovascular Disease Outcomes
The Dietary Approaches to Stop Hypertension (DASH) diet has been shown to lower blood pressure, but little is known about its long-term effect on cardiovascular end points. As a result, a study published in the Archives of Internal Medicine (2008;168:713-720) was performed to assess the association between a DASH-style diet adherence score and risk of coronary heart disease (CHD) and stroke in women. In this prospective cohort study, diet was assessed 7 times during 24 years of follow-up (1980-2004) with validated food frequency questionnaires. A DASH score based on 8 food and nutrient components (fruits, vegetables, whole grains, nuts and legumes, low-fat dairy, red and processed meats, sweetened beverages, and sodium) was calculated. Lifestyle and medical information was collected biennially with a questionnaire. The study population comprised 88,517 female nurses aged 34 to 59 years without a history of cardiovascular disease or diabetes in 1980. The main outcome measures were the numbers of confirmed incident cases of nonfatal myocardial infarction, CHD death, and stroke. During the study, there were 2129 cases of incident nonfatal myocardial infarction, 976 CHD deaths, and 3105 cases of stroke. After adjustment for age, smoking, and other cardiovascular risk factors, the relative risks of CHD across quintiles of the DASH score were 1.0, 0.99, 0.86, 0.87, and 0.76 (P < .001 for trend). The magnitude of risk difference was similar for nonfatal myocardial infarction and fatal CHD. The DASH score was also significantly associated with lower risk of stroke (P = .002 for trend). Cross-sectional analysis in a subgroup of women with blood samples showed that the DASH score was significantly associated with lower plasma levels of C-reactive protein (P = .008 for trend) and interleukin 6 (P = .04 for trend). According to the authors, adherence to the DASH-style diet is associated with a lower risk of CHD and stroke among middle-aged women during 24 years of follow-up.VI. 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.FDA Plans to Open China Office in May 2008
About 40% of pharmaceuticals and 80% of the chemical ingredients in drugs are imported, according to U.S. government statistics. A growing share comes from developing countries such as China, India and Mexico that are still building their own drug safety systems. Health and Human Services Secretary Mike Leavitt said the US Food and Drug Administration (FDA) is planning to open an office in China as part of a change in strategy following product safety problems in Chinese imports that prompted several health scares and have been linked to some deaths. FDA will start working in China next month once Beijing gives its final approval. "In the past, the United States and many other countries have employed a strategy of standing at the border trying to catch things that aren't safe," Leavitt said in an AP interview during a visit to Singapore. However, he said it is impossible to inspect all of the massive amounts of goods that enter the country. As a result, FDA is changing it’s strategy from one of trying to catch unsafe products to building safety into the products. Leavitt added that "Our purpose is not just inspection, it's building capacity and maintaining relationships between regulators." The FDA's China office will be headed by Christopher Hickey, currently director of the Asia and the Pacific office at the Department of Health and Human Services. Hickey, who was with Leavitt in Singapore, said Washington is still awaiting final approval from the Chinese government on the opening of the FDA's office there, but that the agency expected to begin work in May before the official opening of the office in October. No further details were given, but the agency had earlier said they planned to establish eight permanent FDA positions at U.S. diplomatic posts in China. The FDA also said it would hire five Chinese employees in Beijing, Shanghai and Guangzhou. U.S. regulators have recalled a number of contaminated products made in China: toothpaste, pet food, the blood thinner heparin and others. Heparin, a commonly used blood thinner, has been linked to 62 deaths and hundreds of allergic reactions in the U.S. and Germany. Leavitt said the U.S expects to build a presence in a number of other countries, including India and those of the Central American region. He said the safety of food and product imports is "a global problem" driven by a rapid increase in goods being produced and consumed across borders. FDA has started a conversation with the Indian government but no conclusions have been reached. The amount of pharmaceutical trade between the United States and India has grown rapidly. As a result, there are now up to 100 FDA-inspected facilities in India.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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