Information With Integrity Last Update May 1, 2008

Equality For All on the InternetThe AIDS Quilt in D.C. Photo by Diane Knaus

Heart Disease is the Number One Killer of American Women

One in three women die of heart disease which leads to disability and a decreased quality of life. Often the disease can be controlled.

According to the American Heart Association One in five women has some form of heart or blood vessel disease. In 2001, 931,100 people died from heart attacks and other coronary events; of those 498,900 were women

"If You Change Your Diet and Lifestyle, You May Save Your Life"

Colorectal Cancer is the Number Two Killer of Women

It also can be detected early, by a simple test, and save many lives.Learn what to expect about the test, and what not to fear.

 

Coronary Stroke is the Number Three Killer of Women in the United States

Approximately 5000,000 women die each year from heart disease. Risk factors for cardiovascular disease can sometimes be changed through changing our eating habits.

"Save Your Life, Change Your Diet"

 

 

"Lung Cancer is the Leading Killer of All Men and Women in the U. S."

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Protect yourself and your partner from getting Sexually
Transmitted Diseases by using a condom each time
you have intimate relations. Alway wash your entire
body before being intimate, and afterwards with
soap and water. Take extra care that your hands
are clean.( Do not harm each other in violence by
hitting or in the mind by intimidation)

NIDA Researchers Find Genetic Link to Nicotine Addiction and Lung Cancer 4-3-2008

Variant also Increases Risk for Cardiovascular Disease
Scientists have identified a genetic variant that not only makes smokers more susceptible to nicotine addiction but also increases their risk of developing two smoking-related diseases, lung cancer and peripheral arterial disease. The research was supported by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH).

The study, published in the April 3 issue of the journal Nature, "highlights the advances that are being made in genetics research, which can now identify gene variants that increase the risk of complex bio-behavioral disorders," says NIH Director Dr. Elias Zerhouni. "This finding will help us in our efforts to further reduce the scope and devastating consequences of cigarette smoking."

"These results suggest for the first time that a single genetic variant not only can predispose to nicotine addiction but may also increase sensitivity to extremely serious smoking-related diseases," explains NIDA Director Dr. Nora Volkow. "Additionally, it points to potential targets for new smoking-cessation medications that may be more effective at helping smokers to quit."

The variant is closely linked to two of the known subunits of nicotine receptors, the sites on the surface of many cells in the brain and body that can be bound by nicotine. When nicotine attaches to these receptors in the brain, there are changes in cell activity that results in its addictive effects.

Carriers of this genetic variant are more likely than noncarriers to be heavy smokers, dependent on nicotine, and less likely to quit smoking. "The variant does not increase the likelihood that a person will start smoking, but for people who do smoke it increases the likelihood of addiction," says Dr. Kári Stefánsson, the study's principal investigator and chief executive officer of deCODE Genetics, a biopharmaceutical company based in Reykjavik, Iceland.

The variant was identified through a technique known as genome-wide association, in which DNA samples (from more than 10,000 Icelandic smokers) were analyzed for the presence of more than 300,000 genetic markers. Subsequent investigation showed that carriers of the variant strongly associated with nicotine dependence were also at increased risk for two smoking-related diseases, peripheral arterial disease and lung cancer. The findings were replicated in populations from five European countries and New Zealand. The researchers estimate that the variant explains 18 percent of cases of lung cancer and 10 percent of cases of peripheral arterial disease in smokers.

The same variant was identified as one that increased risk for lung cancer in two articles appearing in the April 3rd, 2008, issue of Nature Genetics, partially funded by two other NIH institutes — the National Cancer Institute and the National Human Genome Research Institute.

International Women's Day 2008

Statement by WHO Director-General Dr Margaret Chan
This year's International Women's Day focuses on investing in women and girls. Abundant evidence shows that when women are given an opportunity to express their potential, health indicators rapidly improve for themselves, for households and for communities. Investment in women and girls not only contributes to socioeconomic progress, but is also an investment in health development.

Public health values women as agents of change. Understanding of the power of women to spearhead change has moved into the mainstream of development thinking. The Millennium Declaration – the most ambitious commitment ever made by the international community – recognizes gender equality and the empowerment of women as effective ways to combat poverty, hunger and disease and to stimulate development that is truly sustainable. An in-vestment in women and girls is an investment in sustainable results.

In some of the most challenging circumstances, such as those surrounding conflicts and dis-asters, women stand out as reliable, resilient, and resourceful leaders and forces for holding families and communities together and moving forward. Women have unique ways of devel-oping grassroots networks and know how to use them to meet their personal and collective aspirations for a better life.

But while the potential of women is recognized at the international level, this potential will not be realized until conditions improve – often dramatically – in countries and communities. Too many complex factors, often rooted in social and cultural norms, continue to hinder the ability of women and girls to achieve their potential and benefit from social advances.

This can change. Above all, by protecting and promoting health, we can help improve life conditions for women and girls. We can help make women and girls fit to perform their higher roles in families, communities, and society at large. On this International Women’s Day, let us strengthen our resolve to match their potential with an equally high level of commitment and investment. The payback will be substantial and truly sustainable.

 

FDA and Compounded Menopause Hormone Therapy Drugs 1-9-2008

The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.

The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.

FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible.

The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs."We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," said Dr. Janet Woodcock, FDA's chief medical officer and acting director of the agency's Center for Drug Evaluation and Research. "In addition to today's regulatory action, FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies. Women taking these drugs should discuss with their health care providers the drugs' risks and whether they're getting effective treatment."

FDA Clears First Quick Test For Drug-Resistant Staph InfectionsTest Identifies MRSA Bacterium in Two Hours

The U.S. Food and Drug Administration (FDA) today announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections.

Methicillin is an antibiotic that has been used successfully to treat infections from the Staphylococcus aureus bacterium. Over the years, the staph bacterium mutated and spawned MRSA, a strain of staph bacterium that is resistant to methicillin and which has a higher rate of being fatal.The BD GeneOhm StaphSR Assay uses molecular methods to identify whether a blood sample contains genetic material from the MRSA bacterium or the more common, less dangerous staph bacterium that can still be treated with methicillin.“The BD GeneOhm test is good news for the public health community. Rather than waiting more than two days for test results, health care personnel will be able to identify the source of a staph infection in only two hours, allowing for more effective diagnosis and treatment,” said Daniel G. Schultz, M.D., director, FDA’s Center for Devices and Radiological Health.Staph infections occur most frequently among persons in hospitals and health care facilities (such as nursing homes and dialysis centers) who have weakened immune systems. Both types of bacteria also can infect healthy people.

Distinguishing between the two sources of infection is critical to successful treatment.

The more common, less dangerous strain of staph results in infections that are generally mild and affect the skin with pimples or boils that can be swollen, painful and drain pus.

National Institute of Health News 1-5-2008

"Heart disease is a leading cause of illness, disability and death in industrialized countries, particularly for older people," says National Institute on Aging (NIA) Director Richard J. Hodes, M.D. "We know that certain lifestyle factors like smoking, diet and physical activity greatly affect a person's lipid profiles. This study is an important, basic step in finding the genes that influence lipid levels and heart disease so that we can better understand the genetic contribution to cardiovascular risk."

Environmental and genetic factors influence a person's blood fat, or lipid levels, important risk factors for coronary artery disease (CAD). While there is some understanding of the environmental contribution, the role of genetics has been less defined. Now, in an international collaboration supported primarily by the National Institutes of Health (NIH), scientists have discovered more than 25 genetic variants in 18 genes connected to cholesterol and lipid levels. Seven of the 18 genes previously had not been connected to these levels, while the 11 others confirm previous discoveries. In the investigation, published online January 13 and in the February print issue of Nature Genetics, the associated genes were found through studies of more than 20,000 individuals and more than 2 million genetic variants, spanning the entire genome. These variants potentially open the door to strategies for the treatment and prevention of CAD.

With the statistical power gained by new programs that facilitated pooling of the large SardiNIA, FUSION and Diabetes Genetic Initiative (DGI) datasets, researchers were able to identify variations in 18 genes that influence HDL, LDL and/or triglyceride levels. This list of lipid-associated genes is substantially longer than what was generated by analyses of individual datasets, which had only pointed to one to three genes each. Of the seven newly implicated genes, two were associated with HDL levels, one with LDL levels, three with triglyceride levels and one with both triglycerides and LDL levels. A summary of the data is available online at http://www.sph.umich.edu/csg/abecasis/public/lipids

."These results are yet another example of how genome-wide association studies are opening exciting new avenues for biomedical research," says NHGRI Director Francis S. Collins, M.D., Ph.D., who is a coauthor of the study and an investigator in NHGRI's Genome Technology Branch. "While some of the genetic variants we identified are known to play a well-established role in lipid metabolism, others have no obvious connection. Further studies to identify the precise genes and biological pathways involved could shed new light on lipid metabolism."

 

 

ED Products Online / FDA 1-5-2008

Men looking online for "dietary supplements" to treat erectile dysfunction (ED) or enhance their sexual performance should beware: these products may contain prescription drugs or other undisclosed ingredients that can be harmful.

"The number of these problematic products available on the Internet appears to be increasing," says Linda Silvers, leader of FDA's Internet and Health Fraud Team, part of the Office of Compliance (OOC) in the Center for Drug Evaluation and Research (CDER)."Many consumers perceive these products as completely safe because they are often sold with labeling, suggesting that they are all-natural alternatives to prescription drug products that have been approved by FDA for treating ED," she says. "But these products may be laced with potentially hazardous ingredients that aren't noted on the label."

Viagra Ingredient Found Working with other FDA components, Silvers' team led an Internet survey in which more than one-third of purchased "dietary supplements" claiming to spur sexual enhancement or treat ED contained undisclosed prescription drug ingredients or similar substances."Six of the 17 products we bought contained sildenafil (the active ingredient in Viagra) or a substance similar to either sildenafil or vardenafil," says Silvers. Vardenafil is the active ingredient in Levitra, another FDA-approved prescription drug that treats ED.
Mark Hirsch, a Medical Team Leader in CDER's Division of Reproductive and Urologic Products, says this undisclosed presence of prescription drug ingredients—and similar compounds known as analogs of the drugs—can lead to serious side effects in users.

Dangerous Interactions

"These products may interact in dangerous ways with drugs that a consumer is already taking," Hirsch says. For example, taking sildenafil in addition to certain prescription drugs containing nitrates may lower blood pressure to an unsafe level.

People with diabetes, high blood pressure, high cholesterol, or heart disease are often prescribed drugs containing nitrates, and men with these conditions commonly suffer from ED, Hirsch says. "Those are factors that doctors consider when prescribing approved ED treatments."

Preventive Measures

Silvers says FDA has determined that many of these products or their active ingredients are imported into the United States from other countries.

"FDA is working closely with U.S. Customs and Border Protection to develop a more effective network to successfully screen and stop these shipments from entering U.S. commerce," says Sally Eberhard, Acting Team Leader of OOC's Import-Export Team.

Silvers adds that the agency is also evaluating innovative ways to educate consumers about the risks of buying such sexual enhancement products and other drugs online.

"Hero of Emergency Medicine"

Washington, D.C. - The American College of Emergency Physicians (ACEP) today announced it has recognized Larry Linder, MD, FACEP, senior vice president and chief medical officer at Baltimore Washington Medical Center, as a "Hero of Emergency Medicine." The campaign, which is part of ACEP's 40th anniversary, recognizes emergency physicians who have made significant contributions to emergency medicine, their communities and their patients.

"Emergency physicians are on the front lines of America's health care system, providing the essential community service of emergency care," says ACEP President Linda L. Lawrence, MD. "The dedication, passion and commitment Dr. Linder has shown embodies the vision of ACEP's founders and the ideals of our specialty."

Dr. Linder, who also serves as chair of the emergency department at Baltimore Washington Medical Center, is a visionary with practicality and execution, an outstanding leader, and an exceptional emergency physician. He champions legislative issues, and along with Dr. David Davis, helped write and pass the Prudent Layperson Definition, making Maryland the first state in the nation to enact it. During his four years as Maryland ACEP president, he instituted the pre-hospital provider award and developed the chapters Administrative Resident Mentor program. He has headed the Maryland ACEP Education Committee for the past seven years. He developed the "Legal Jeopardy Game" to familiarize emergency medicine personnel with Maryland's health laws, and he is involved with Maryland ACEP's public policy and advocacy programs.

At Baltimore Washington Medical Center, he has worked tirelessly to solve on-call specialty challenges and the "ED back door" issue, mentor leaders throughout the hospital, address reimbursement problems, and remain a model of fairness in his dealings with all members of his hospital community.

"The American College of Emergency Physicians is celebrating 40 years of advancing emergency care, and the nation's emergency physicians are dedicated to saving even more lives and to improving emergency care for the next 40 years," said Dr. Lawrence. "Tens of thousands of lives are saved each year by emergency physicians and 115 million patients are treated in the nation's emergency departments. Emergency physicians are medical specialists who are experts in their field."

ACEP is a national medical specialty society representing emergency medicine with more than 25,000 members. ACEP is committed to advancing emergency care through continuing education, research and public education. Headquartered in Dallas, Texas, ACEP has 53 chapters representing each state, as well as Puerto Rico and the District of Columbia. A Government Services Chapter represents emergency physicians employed by military branches and other government agencies.

CDC Statement on MRSA in Men Who Have Sex with Men 1-16-2008

MRSA is a common cause of skin infections throughout the United States. These infections occur in men, women, adults, children, and persons of all races and sexual orientations, and are known to be transmitted by close skin-to-skin contact. In this issue of the Annals of Internal Medicine, Diep et al looked at isolates of MRSA - USA300 strains containing a particular plasmid associated with additional drug resistance. The paper shows that multidrug-resistant USA300 has emerged as an important source of disease among men with have sex with men in 2 geographically distinct communities.

The strains of MRSA described in the recent Annals of Internal Medicine have mostly been identified in certain groups of men who have sex with men (MSM), but have also been found in some persons who are not MSM. It is important to note that the groups of MSM in which these isolates have been described are not representative of all MSM, so conclusions can not be drawn about the prevalence of these strains among all MSM. The groups studied in this report may share other characteristics or behaviors that facilitate spread of MRSA, such as frequent skin-to-skin contact.CDC’s extensive and continuing study of invasive MRSA in 9 US states indicates that these strains are rare. CDC continues to monitor resistance patterns and strain characteristics in MRSA isolates submitted to CDC for a variety of investigations.

Bacteria are able to acquire resistance to antibiotics. It is concerning that these bacteria are becoming resistant to more antibiotics than the typical community associated-MRSA strains because this limits the available treatment options. Fortunately, there are still effective choices available to treat infections when antibiotics are required, including those antibiotics given by mouth. It remains important to do what we can to prevent transmission of these strains and of MRSA in general.MRSA is typically transmitted through skin-to-skin contact, which occurs during a variety of activities, including sex. There is no evidence at this time to suggest that it MRSA is a sexually-transmitted infection in the classical sense.

Therefore, CDC believes that our recommended prevention measures for CA-MRSA in general are also the most appropriate response to the strains described among MSM.

You can prevent spreading staph or MRSA skin infections to others by following these steps:
1. Cover your wound. Keep wounds that are draining or have pus covered with clean, dry bandages. Follow your healthcare provider’s instructions on proper care of the wound. Pus from infected wounds can contain staph and MRSA, so keeping wounds covered will help prevent the spread to others. Bandages or tape can be discarded with the regular trash.
2. Clean your hands. You, your family, and others in close contact should wash their hands frequently with soap and warm water or use an alcohol-based hand sanitizer, especially after changing the bandage or touching the infected wounds.
3. Do not share personal items. Avoid sharing personal items such as towels, washcloths, razors, clothing, or uniforms that may have had contact with infected wounds or bandages. Wash sheets, towels, and clothes that become soiled with water and laundry detergent. Drying clothes in a hot dryer, rather than air-drying, also helps kill bacteria in clothes.
4. Talk to your doctor. Tell any healthcare providers who treat you that you have or had a staph or MRSA skin infection.

International Consortium Announces the 1000 Genomes Project 1-24-2008

An international research consortium recently announced the 1000 Genomes Project, an ambitious effort that will involve sequencing the genomes of at least 1,000 people from around the world to create the most detailed and medically useful picture to date of human genetic variation. The project will receive major support from the Wellcome Trust Sanger Institute in Hinxton, England, the Beijing Genomics Institute, Shenzhen (BGI Shenzhen) in China and the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH).

"This new project will increase the sensitivity of disease discovery efforts across the genome five-fold and within gene regions at least 10-fold," said NHGRI Director Francis S. Collins, M.D., Ph.D. "Our existing databases do a reasonably good job of cataloging variations found in at least 10 percent of a population. By harnessing the power of new sequencing technologies and novel computational methods, we hope to give biomedical researchers a genome-wide map of variation down to the 1 percent level. This will change the way we carry out studies of genetic disease."


"The 1000 Genomes Project will examine the human genome at a level of detail that no one has done before," said Richard Durbin, Ph.D., of the Wellcome Trust Sanger Institute, who is co-chair of the consortium. "Such a project would have been unthinkable only two years ago. Today, thanks to amazing strides in sequencing technology, bioinformatics and population genomics, it is now within our grasp. So we are moving forward to build a tool that will greatly expand and further accelerate efforts to find more of the genetic factors involved in human health and disease."

With current approaches, researchers can search for two types of genetic variants related to disease. The first type is very rare genetic variants that have a severe effect, such as the variants responsible for causing cystic fibrosis and Huntington's disease. To find these rare variants, which typically affect fewer than one in 1,000 people, researchers often must spend years on studies involving affected families. However, most common diseases, such as diabetes and heart disease, are influenced by more common genetic variants. Most of these common variants have weak effects, perhaps increasing risk of a common condition by 25 percent or less.

Recently, using a new approach known as a genome-wide association study, researchers have been able to search for these common variants.

"Between these two types of genetic variants — very rare and fairly common — we have a significant gap in our knowledge. The 1000 Genomes Project is designed to fill that gap, which we anticipate will contain many important variants that are relevant to human health and disease," said David Altshuler, M.D., Ph.D., of Massachusetts General Hospital in Boston and the Broad Institute of Massachusetts Institute of Technology (MIT) and Harvard University in Cambridge, Mass., who is the consortium's co-chair and was a leader of the HapMap Consortium.

Are You Tired Everyday? 3-2-2008

About 10 percent of adults report not getting enough rest or sleep every day in the past month, according to a new four-state study released by the Centers for Disease Control and Prevention?s (CDC) Morbidity and Mortality Weekly Report.

The data from the four states–Delaware, Hawaii, New York, and Rhode Island–may not reflect national trends. But an additional study conducted by CDC utilizing data from the National Health Interview Study indicated that across all age groups the percentage of adults who, on average, report sleeping six hours or less has increased from 1985 to 2006.

Nationwide, an estimated 50 to 70 million people suffer from chronic sleep loss and sleep disorders. Sleep loss is associated with health problems, including obesity, depression, and certain risk behaviors, including cigarette smoking, physical inactivity, and heavy drinking.

“It?s important to better understand how sleep impacts people?s overall health and the need to take steps to improve the sufficiency of their sleep,” said Lela R. McKnight-Eily, Ph.D., the study?s lead author and a behavioral scientist in CDC?s Division of Adult and Community Health. “There are very few studies to assess and address sleep insufficiencies; therefore, more needs to done to better understand the problem and to develop effective sleep interventions.”

The study, “Perceived Insufficient Rest or Sleep--Four States, 2006,” analyzed data from CDC?s Behavioral Risk Factor Surveillance System (BRFSS) survey. Among the four states, the percentage of adults who reported not getting enough rest or sleep every day in the past 30 days ranged from 14 percent in Delaware to 8 percent in Hawaii.

People concerned about chronic sleep loss should consult a physician for an assessment and possible treatment, such as behavioral or medical interventions, McKnight-Eily said. They can also try setting a regular sleep schedule and avoiding caffeine or other stimulants before bed, she said.

Variation for insufficient rest and sleep may be due to occupational or lifestyle factors. The causes of sleep loss could include busy schedules or shift work; irregular sleep schedules; or lifestyle factors such as heavy family demands, late–night television watching and Internet use, or the use of caffeine and alcohol, according to a 2006 Institute of Medicine report. The National Sleep Foundation reports that most adults need 7-9 hours of sleep each night to feel fully rested while school children aged 5-12 years require 9-11 hours, and adolescents aged 11-17 years require 8.5–9.5 hours each night.

The study also found that the prevalence of insufficient sleep decreased with age. An estimated 13.3 percent of adults aged 18-34 reported insufficient rest or sleep everyday in the past month compared to only 7.3 percent of adults ages 55 and older. While some studies have found sleep disturbance more prevalent among older adults, results from this study are consistent with other research that supports the idea that older adults (who are more likely to be retired) make fewer complaints regarding impaired sleep and adapt their perception of what encompasses sufficient sleep.

In addition, the study showed that only one out of three (29.6 percent) adults said they did get enough rest or sleep every day in the past month.
The MMWR report said the definitions of “enough” (sufficient) sleep and “rest,” and responses to the survey question were subjective and were not measured or equated to reports of hours of sleep per night. The report said the analysis cannot be compared directly with studies measuring hours of sleep. The survey question also did not define or distinguish between “rest” and “sleep.”

The study comes just before National Sleep Awareness Week®, an annual campaign held in conjunction with Daylight Saving Time. For more information on National Sleep Awareness Week®, held March 3-9, please visit www.sleepfoundation.org.

 

Latino AIDS Commission to Honor Dr. Mathilde Krim May 13,2008

On May 13, the Latino AIDS Commission will honor leaders in the fight against HIV/AIDS at their annual gala, Cielo Latino. amfAR Founding Chairman Dr. Mathilde Krim will accept the Fuerza Award for her commitment to stopping the spread of HIV/AIDS.

Cielo Latino is the largest annual national fundraiser for the Latino community in its fight against HIV/AIDS. In its 13th year, Cielo Latino is a prominent and highly visible platform for leaders in business, government, entertainment and the media to showcase their philanthropy for AIDS.

Thursday, May 13th, 2008
Cipriani Wall Street
55 Wall Street
New York, NY 10005

NIH Study-Brain Study May Lead to Improved Epilepsy Treatments 4-16-2008

Using a rodent model of epilepsy, researchers found one of the body’s own neurotransmitters released during seizures, glutamate, turns on a signaling pathway in the brain that increases production of a protein that could reduce medication entry into the brain. Researchers say this may explain why approximately 30 percent of patients with epilepsy do not respond to antiepileptic medications. The study, conducted by researchers at the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health, and the University of Minnesota College of Pharmacy and Medical School, in collaboration with Heidrun Potschka’s laboratory at Ludwig-Maximilians-University in Munich, Germany, is available online and will appear in the May 2008, issue of Molecular Pharmacology.

"Our work identifies the mechanism by which seizures increase production of a drug transport protein in the blood brain barrier, known as P-glycoprotein, and suggests new therapeutic targets that could reduce resistance," said David Miller, Ph.D., a principal investigator in the NIEHS Laboratory of Pharmacology and co-author on the paper.

The blood-brain barrier (BBB), which resides in brain capillaries, is a limiting factor in treatment of many central nervous system disorders. It is altered in epilepsy so that it no longer permits free passage of administered antiepileptic drugs into the brain. Miller explained that P-glycoprotein forms a functional barrier in the BBB that protects the brain by limiting access of foreign chemicals.

"The problem is that the protein does not distinguish well between neurotoxicants and therapeutic drugs, so it can often be an obstacle to the treatment of a number of diseases, including brain cancer," Miller said. Increased levels of P-glycoprotein in the BBB has been suggested as one probable cause of drug resistance in epilepsy.

Using isolated brain capillaries from mice and rats and an animal model of epilepsy, the researchers found that glutamate, a neurotransmitter released when neurons fire during seizures, turns on a signaling pathway that activates cyclooxygenase-2 (COX-2), causing increased synthesis of P-glycoprotein in these experiments. Increased transporter expression was abolished in COX-2 knockout mice or by COX-2 inhibitors. It has yet to be shown in animals or patients that targeting COX-2 will reduce seizure frequency or increase the effectiveness of anti-epileptic drugs.

"These findings provide insight into one mechanism that underlies drug resistance in epilepsy and possibly other central nervous system disorders," said Bjoern Bauer, Ph.D., lead author on the publication. "Targeting blood-brain barrier signals that increase P-glycoprotein expression rather than the transporter itself suggests a promising way to improve the effectiveness of drugs that are used to treat epilepsy, though more research is needed before new therapies can be developed."

Fat Waisteline is DangerousRisk 4-15-2008

Excess Fat Around the Waist May Increase Death Risk For Women
Women who carry excess fat around their waists were at greater risk of dying early from cancer or heart disease than were women with smaller waistlines, even if they were of normal weight, reported researchers from Harvard and the National Institutes of Health.

Previous studies have shown that the tendency to deposit fat around the waist increases the risk for health problems. The current study is the largest, most comprehensive of its kind undertaken to show that accumulation of abdominal fat can increase the risk of death.

To conduct the study, the researchers analyzed data from more than 44,000 women in the Nurses’ Health study, which followed the health history of thousands of registered nurses in 11 states.
"As we know from the work of the NIH Obesity Research Task Force, reversing the epidemic of obesity is challenging," said Elias A. Zerhouni, M.D., Director of the National Institutes of Health. "The current findings highlight the role that research can play in understanding the risks of obesity."

The study was published online in Circulation.
There is increasing evidence that excess abdominal fat is a risk factor for long-term conditions like diabetes and heart disease. However, the relationship between abdominal obesity and risk of death has not been widely studied. The current study is one of the largest extended investigations of abdominal obesity and women’s risk of premature death.

Researchers followed more than 44,000 women over the course of 16 years to track their medical history and lifestyle. Because the majority of the women who took part in the study were white, the researchers do not know if their findings pertain to other groups of women or to men.

All the women included in the study were registered nurses. At the beginning of the study the women were asked to measure their waists and hips. Every two years, the women completed questionnaires about their health, providing information about their age, activity level, smoking status, diet, blood pressure and cholesterol levels.
The researchers examined the cause of death for all women who died over the course of the study. In total, 3,507 deaths occurred — of these, 1,748 were due to cancer and 751 were due to heart disease.

The researchers discovered that women with greater waist circumferences were more likely to die prematurely, particularly from heart disease, when compared to women with smaller waists. For example, women with waist size equal to or greater than 35 inches were approximately twice as likely to die of heart disease as were women with a waist size less than 28 inches, regardless of their body mass index. Similarly, women with a waist size equal to or greater than 35 inches also were twice as likely to die of cancer as were women with a waist size less than 28 inches.

Women who had a greater waist circumference and were also obese were at the greatest risk of premature death. Researchers determined if a woman was overweight by calculating her body mass index (BMI), a measure of a person’s weight in relation to height. BMI is used to estimate the proportion of a person’s weight that derives from body fat. A BMI between 18.5 and 24.9 is considered healthy. A BMI of 30.0 - 39.9 is regarded as obese.

Climate Change Will Erode Foundations of Health

WHO Director-General warns vulnerable populations at greatest risk of projected impacts

7 APRIL 2008 | GENEVA -- Scientists tell us that the evidence the Earth is warming is "unequivocal." Increases in global average air and sea temperature, ice melting and rising global sea levels all help us understand and prepare for the coming challenges. In addition to these observed changes, climate-sensitive impacts on human health are occurring today. They are attacking the pillars of public health. And they are providing a glimpse of the challenges public health will have to confront on a large scale, WHO Director-General Dr Margaret Chan warned today on the occasion of World Health Week.

Topical overview: climate change "The core concern is succinctly stated: climate change endangers human health," said Dr Chan. "The warming of the planet will be gradual, but the effects of extreme weather events -- more storms, floods, droughts and heat waves -- will be abrupt and acutely felt. Both trends can affect some of the most fundamental determinants of health: air, water, food, shelter and freedom from disease."

Human beings are already exposed to the effects of climate-sensitive diseases and these diseases today kill millions. They include malnutrition, which causes over 3.5 million deaths per year, diarrhoeal diseases, which kill over 1.8 million, and malaria, which kills almost 1 million.

Examples already provide us with images of the future:
• European heat wave, 2003: Estimates suggest that approximately 70 000 more people died in that summer than would have been expected.
• Rift Valley fever in Africa: Major outbreaks are usually associated with rains, which are expected to become more frequent as the climate changes.
• Hurricane Katrina, 2005: More than 1 800 people died and thousands more were displaced. Additionally, health facilities throughout the region were destroyed critically affecting health infrastructure.
• Malaria in the East African highlands: In the last 30 years, warmer temperatures have also created more favourable conditions for mosquito populations in the region and therefore for transmission of malaria.
• Epidemics of cholera in Bangladesh: They are closely linked to flooding and unsafe water.
These trends and events cannot be attributed solely to climate change but they are the types of challenges we expect to become more frequent and intense with climate changes. They will further strain health resources that, in many regions, are already under severe stress.
"Although climate change is a global phenomenon, its consequences will not be evenly distributed," said Dr Chan. "In short, climate change can affect problems that are already huge, largely concentrated in the developing world, and difficult to control."

To address the health effects of climate change, WHO is coordinating and supporting research and assessment on the most effective measures to protect health from climate change, particularly for vulnerable populations such as women and children in developing countries, and is advising Member States on the necessary adaptive changes to their health systems to protect their populations.

WHO and its partners -- including the UN Environment Programme, the Food and Agriculture Organization, and the UN World Meteorological Organization -- are devising a workplan and research agenda to get better estimates of the scale and nature of health vulnerability and to identify strategies and tools for health protection. WHO recognizes the urgent need to support countries in devising ways to cope. Better systems for surveillance and forecasting, and stronger basic health services, can offer health protection. WHO will be working closely with its Member States in coming years to develop effective means of adapting to a changing climate and reducing its effects on human health.

"Through its own actions and its support to Member States," said Dr Chan, "WHO is committed to do everything it can to ensure all is done to protect human health from climate change."

According to NIH DNA Shows Risk for Breast Cancer 3-30-2008

Researchers have identified genetic variations in a region of DNA that may be associated with the risk for breast cancer. The finding is just the latest from a slew of ongoing genome-wide association studies funded by NIH.

Genome-wide association studies look across the entire genome for changes in the genetic code that are more frequent in people who have a certain disease than in similar people who don't. Researchers at NIH's National Cancer Institute (NCI) led a nation-wide research team in a 3-phase genome-wide association study into breast cancer. It was coordinated by researchers at Memorial Sloan-Kettering Cancer Center in New York, with participation from other centers in the United States, Canada and Israel.

Mutations in BRCA genes were identified in the 1990s as one of the strongest known genetic risk factors for breast cancer. In the current study, the researchers chose women who didn't carry the BRCA mutations so that they could uncover other influences. The researchers first analyzed more than 150,000 genetic variations in DNA samples from 249 Ashkenazi Jewish women who had breast cancer and a family history of the disease. The results were then compared to DNA samples from 299 Ashkenazi Jewish women who had not developed cancer. In the next 2 phases, the researchers verified their findings in over 2,000 more Ashkenazi Jewish women, about half with breast cancer and half without.

The team reported their results online in the Proceedings of the National Academy of Sciences on March 3, 2008. They found that 4 genetic variations located in a region of chromosome 6 were present more often in the breast cancer patients, suggesting that genes in this region might contribute to the risk of breast cancer. Variations in the region appeared to increase the risk of developing breast cancer by 1.4 times.

World Shortage of Health Care Workers 3-12-2008

KAMPALA -- The first Global Forum on Human Resources for Health called for immediate and sustained action to resolve the critical shortage of health workers around the world, setting out the essential steps that need to be taken over the next decade to turn the crisis around.

Nearly 1500 participants, including donors, experts and more than 30 ministers of health, education and finance, endorsed the Kampala Declaration and Agenda for Global Action. The Forum, held in Kampala, Uganda, and organized by the Global Health Workforce Alliance (GHWA), mandated the Alliance to monitor progress made on the Agenda and report its findings in 2010. "Health workers are the cornerstone of health systems and action is long overdue. This Forum and the Agenda bring much needed attention to the issue," said WHO Deputy Director-General Dr Anarfi Asamoa-Baah who spoke at the Forum.

The Agenda calls on all countries to give top priority to training and recruiting sufficient health personnel from within their own country and to provide adequate incentives and better working conditions to ensure the retention of health workers. It calls on international and regional financial institutions to relax constraints such as public health recruitment ceilings, and calls on WHO to accelerate negotiations for a code of practice on the international recruitment of health workers.

"This is about much more than a health issue. It is about political choice. It is about quality of life and the dignity of individuals. Therefore, providing health workers for all is the responsibility of all societies and their governments," said Dr Francis Omaswa, Executive Director of GHWA, which is based at WHO.

WHO estimates that the world needs over 4 million additional health workers, and 57 countries are suffering from an acute shortage. Sub-Saharan Africa is particularly affected by this crisis, with one million health workers needed for this region alone.

FDA and STD Warnings

The U.S. Food and Drug Administration today issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs).

Some of these products, directed at U.S. consumers, falsely claim to have "FDA Approval" and some claim to be "more effective" than conventional medicine. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products.

"The products pose a serious health threat to unsuspecting consumers who don’t know that these products are not FDA approved and have not been proven safe or effective," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research. "STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs."

The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The FDA considers these U.S. and imported products to be unapproved new drugs being marketed in violation of the Federal Food, Drug and Cosmetic Act. They are also misbranded under the law because they lack proper directions for use by consumers. In addition, some of the products are misbranded because they make false and misleading claims.

Examples of claims that these products make include "Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications," "Greatest STD Protection Without Condoms," (SlicPlus) and "The active ingredient in our product is FDA certified to destroy 99.9992 percent of all pathogenic organisms [ie] Chlamydia" (OXi-MED).

The Warning Letters inform the companies that failure to properly resolve violations of the law may cause them to face further enforcement action that can include seizure of illegal products, injunction, and possible criminal prosecution.

FDA Public Health Update
Recall of Heparin Sodium Injection and Heparin Lock Flush Solution (Baxter) 

"Heparin manufctured in China"

The Food and Drug Administration is issuing this update to inform the public that
• Baxter Healthcare Corporation has extended its recall of multi-dose vials of heparin sodium for injection to also include single-dose vials of heparin sodium for injection.
• As a precautionary measure Baxter is also recalling its heparin lock flush products.  The heparin source manufacturer for lock flush solutions is the same as that for Baxter’s heparin sodium for injection. 
• Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the US market.

Since FDA learned of the adverse events associated with the Baxter multi-dose heparin vials, the Drug Shortages Team at FDA has been working closely with APP, the other supplier in the US for heparin multi-dose and single-dose vials, to determine their manufacturing capacity.  With the verification that APP can now adequately supply the US market Baxter is voluntarily recalling all of its multi-dose and single-dose vials.  FDA has also confirmed that there are multiple U.S. suppliers of heparin lock flush products with substantial inventory, making a shortage of these products unlikely.

This drug is used primarily by people undergoeing dialysis tretaments, and cardiac arrest treatments.

According to the FDA

How is FDA investigating this problem?
We are investigating all possible sources of the problem, including evaluating the active pharmaceutical ingredient manufacturing facility, located in China, and finished dosage form manufacturing facility, located in New Jersey.  We will be inspecting these facilities as soon as possible.  In addition, FDA is performing comprehensive laboratory analysis of the heparin.  FDA is collaborating with the CDC and other experts to determine the root cause of the problem.  FDA is also working closely with its international counterparts, in case they have any relevant information.

The recall notice issued by Baxter provides instructions to healthcare providers and institutions regarding the identification and disposition of their product they may have in their inventories. The only Baxter heparin-containing products that will remain on the market are large volume parenteral solutions containing 200 Units of heparin per 100 cc in 500 and 1000 cc total volume bags.  No adverse events have been reported in relation to the large volume solution.  The heparin source manufacturer for the large volume solution is different from that of the products being recalled.

On February 11, 2008, the FDA issued a public health advisory informing the public about reports of serious adverse events in patients who received bolus injections of heparin sodium primarily from multi-dose vials manufactured by Baxter Healthcare Corporation.  A description of the clinical settings and characteristics of the cases of serious adverse events that resulted in the public health advisory can be found at http://www.fda.gov/cder/drug/advisory/heparin.htm.

The underlying cause of adverse events reported for Baxter’s heparin sodium is still unknown and remains under investigation.   FDA investigators and scientists are working independently and in collaboration with the Centers for Disease Control and Prevention, and Baxter to discover the underlying cause of the adverse events. 

FDA continues to monitor its post-marketing safety database for additional cases in the US and abroad related to heparin usage.  Health care providers are encouraged to report all allergic-type reactions to any heparin infusion to FDA’s MedWatch on line at http://www.fda.gov/medwatch/report/hcp.htm, by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.

New survey finds highest rates of drug-resistant TB to date

FEBRUARY 2008 | WASHINGTON DC /GENEVA -- Multidrug-resistant tuberculosis (MDR-TB) has been recorded at the highest rates ever, according to a new report published today. The report presents findings from the largest survey to date on the scale of drug resistance in tuberculosis.
Anti-tuberculosis drug resistance in the world

The report, "Anti-tuberculosis drug resistance in the world", is based on data collected between 2002 and 2006 on 90 000 TB patients in 81 countries. It found that extensively drug-resistant tuberculosis (XDR-TB), a virtually untreatable form of the respiratory disease, has been recorded in 45 countries.

The report also found a link between HIV infection and MDR-TB. Surveys in Latvia and Ukraine found nearly twice the level of MDR-TB among TB patients living with HIV compared with patients without HIV.
Based on the analysis of the survey data, WHO estimates there are nearly half a million new cases of MDR-TB a year, which is about 5% of nine million new TB cases of all types. The highest rate was recorded in Baku, the capital of Azerbaijan, where nearly a quarter of all new TB cases (22.3%) were reported as multidrug-resistant.

Proportions of MDR-TB among new TB cases were 19.4% in Moldova, 16% in Donetsk in Ukraine, 15% in Tomsk Oblast in the Russian Federation, and 14.8% in Tashkent in Uzbekistan. These rates surpass the highest levels of drug resistance published in the last WHO report in 2004. Surveys in China also suggest that MDR-TB is widespread there.

CDC Study Warns of Deaths Due to the “Choking Game 2-20-2008

Most fatalities in 11-to-16 year old boys

At least 82 youth have died as a result of playing what has been called “the choking game,” according to a study released by the Centers for Disease Control and Prevention in today?s Morbidity and Mortality Weekly Report. The choking game involves intentionally trying to choke oneself or another in an effort to obtain a brief euphoric state or “high.” Death or serious injury can result if strangulation is prolonged.

Eighty–seven percent of these deaths were among males, and most fatalities occurred among those 11 years to 16 years old; the average age was 13, the report said. Choking game deaths were identified in 31 states, it said.

CDC found that most of the deaths occurred when a child engaged in the choking game alone, and that most parents were unaware of the choking game prior to their child?s death.

“Because most parents in the study had not heard of the choking game, we hope to raise awareness of the choking game among parents, health care providers, and educators, so they can recognize warning signs of the activity,” said Robin L. Toblin, Ph.D., M.P.H., the study?s lead author. “This is especially important because children themselves may not appreciate the dangers of this activity.”
Three or fewer choking game–related deaths per year were reported in the news media from 1995 to 2004, the report said. However, 22 deaths occurred in 2005, and 35 in 2006. Nine deaths occurred in the first 10 months of 2007; the explanation for this decrease is unclear. The researchers said the study probably underestimates the number of deaths.
For this study, CDC analyzed media reports of deaths attributed to the choking game. Deaths were not included unless the report provided evidence that they were a result of the choking game.

“This report is an important first step in identifying the choking game as a public health problem,” said Ileana Arias, Ph.D., director of CDC?s Injury Center. “More research is needed to identify risk factors that may contribute to kids playing the choking game and to determine what may help to reduce this type of behavior.”

Signs that a child may be engaging in the choking game include
• discussion of the game ––including other terms used for it, such as “pass–out game” or “space monkey”;
• bloodshot eyes;
• marks on the neck;
• severe headaches;
• disorientation after spending time alone;
• ropes, scarves, and belts tied to bedroom furniture or doorknobs or found knotted on the floor;
• unexplained presence of things like dog leashes, choke collars and bungee cords

If parents believe their child is playing the choking game, they should speak to them about the life–threatening dangers associated with the game and seek additional help if necessary.
For more information about CDC?s work in injury and violence prevention, please link to: http://www.cdc.gov/injury.

 

 

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Women & HIV Conference 4-2008

The Women & HIV International Clinical Conference, jointly sponsored by amfAR and the Texas/Oklahoma AIDS Education & Training Center, will take place April 27–30, 2008, at the Magnolia Hotel in Dallas, Texas. The conference will focus on improving patient outcomes for HIV-positive women by providing clinicians in the HIV/AIDS field with the latest, evidence-based information. amfAR will provide Continuing Medical Education credits to participating healthcare professionals.

Representatives of amfAR’s education and public policy departments are serving on the planning committee for the conference. The agenda, which was designed to maximize interaction between participants and faculty, will include three areas of focus: biomedical, psych/social, and policy/advocacy.

The deadline for submission of abstracts has been extended through Wednesday, February 13th. For abstract submission or to register for the conference, visit the WHICC website by clicking here.

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of amfAR, The Foundation for AIDS Research and Parkland Health and Hospital System. amfAR, The Foundation for AIDS Research is accredited by the ACCME to provide continuing medical education for physicians.

amfAR designates this educational activity for a maximum of 12.25 AMA PRA Category 1 Credits™. Physicians should claim credit commensurate with the extent of their participation in the activity.

Mouse Studies and Tumors 4-21-2008


New research has shown that the function of a type of cell that helps modulate immune responses is impaired inside tumors in mice. Researchers also identified several factors that may contribute to an accumulation of these cells, called T regulatory cells (Tregs), within and around the tumor, which may be how they respond to their loss of functionality. The study, by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health, appeared online April 18, 2008, in The Journal of Immunology.

"These findings provide insight into the impact of a growing tumor on the immune system," said Helen Sabzevari, Ph.D., of NCI's Center for Cancer Research, an author of the study. "Understanding the tumor's effects on Tregs and how these cells maintain themselves inside tumors, and in the environment immediately surrounding tumors, will be important for designing new immunotherapies."

Tregs are a specialized subset of T cells that help manage the immune system by suppressing the response of immune cells once a foreign invader has been defeated. They also prevent autoimmune diseases by keeping the body from attacking its own cells and tissues or reacting to its own antigens, called self-antigens. Since tumor-associated antigens are primarily derived from self-antigens, Treg cells also play an important role in suppressing immune responses directed against tumors, yet Tregs are thought to somehow escape the immunosuppressive effects of the tumor microenvironment.

Previous studies have shown that the suppressive actions of Tregs require other immune cells to first become activated through the T cell receptor (TCR), a surface landing site where these cells recognize and bind to begin an immune response. This triggers the eventual suppressive activity of Tregs through a step-wise series of biochemical events called signaling pathways.

In laboratory experiments, Sabzevari's team demonstrated that Tregs taken from the spleens of mice bearing tumors exhibited a less suppressive influence on the rate of proliferation of immune cells than did Tregs from spleens of the same strain of mice without tumors. In addition, they found that suppression of overall immune responses decreased about 2.4-fold in tumor-associated Tregs when compared to normal Tregs in the spleen.
To explore possible mechanisms for a tumor's effects on Treg cell function, the researchers implanted cancer cells under the skin of mice. Then they compared gene expression patterns in Tregs collected from spleen tumors that formed in mice implanted with Treg cells vs. expression patterns of spleens of implant-free control mice. Microarray analysis — which allows researchers to examine the activity of thousands of genes simultaneously — revealed differences in the gene expression of several types of genes, including those involved in immune responses, signal transduction, T cell activation, and the TCR signaling pathway. Comparing individual genes, they found reduced expression of several molecules that are involved in TCR signaling in the tumor-associated Tregs when compared to normal Treg cells.

Further analysis indicated that Treg cells in tumors lose some of their functionality because they do not become effectively activated. "Our studies demonstrate that Treg cells from tumors are less capable of responding to activation through the TCR than are Treg cells from normal spleens, indicating that the tumor microenvironment inhibits functionality of Treg cells," said Sabzevari.

In some human cancers, the number of Tregs increases in the peripheral blood, and these cells accumulate at the site of tumors. Increases in Treg cell numbers also have been observed in the spleen of animal tumor models.

Similarly, in this new research, as tumors grew larger in implanted mice, the number of Treg cells increased in both the spleen and in the tumors, but, in tumors, the percent of Treg cells actively copying themselves was 23 to 43 percent of the population of Tregs compared to 11 to 16 percent in the spleen. Additionally, cell death in the tumor-associated Tregs was two percent compared to 11 percent for spleen-associated Tregs in the same animals, likely because of the increased expression of other molecules that interfere with factors that signal cell death.

Despite their reduced functionality, the accumulation of larger numbers of Tregs in tumors may still allow the suppression of antitumor immune responses. Targeting Treg cells may be one way of improving cancer immunotherapy.

"Our findings indicate that treatments, such as chemotherapy or radiation therapy, can directly affect Treg cells," said Sabzevari. "By decreasing the number of Treg cells at the site of tumors, treatments, such as immunotherapies, may be more effective."

Factors of Premature Babies Survival 4-17-2008


Based on observations of more than 4,000 infants, researchers in an NIH newborn research network have identified several factors that influence an extremely low birth weight infant's chances for survival and disability. The findings offer new information to physicians and families considering the most appropriate treatment options for this category of infants.

Every day, physicians and new parents must struggle with the type of care to provide to extremely low birth weight infants, the smallest, most frail category of preterm infants. These infants are born in the 22nd through the 25th week of pregnancy — far earlier than the 40 weeks of a full term pregnancy. Many die soon after birth, despite the best attempts to save them, including the most sophisticated newborn intensive care available. 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.

The study authors referred to the issue of providing intensive care for extremely low birth weight infants. For example, physicians and family members may be reluctant to expose an infant to painful life support procedures if the infant is unlikely to survive. In such cases, they may opt for "comfort care," which provides for an infant's basic needs, but foregoes painful medical procedures. In deciding the kind of care to provide, 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 comfort care.

The study authors noted, however, that it is often difficult to assess gestational age. Moreover, an estimate that is inaccurate by only a week could result in an infant receiving care that was not appropriate for his or her individual case. To identify other factors that influenced survival and disability risk, the study authors observed more than 4,000 extremely low birth weight infants in their network.

The researchers published their findings in the April 17 New England Journal of Medicine. In addition to gestational age, factors influencing survival and risk of disability consisted of: whether the baby is male or female (sex); 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.

CDC Releases Stroke Report -31-2008

Stroke is the third leading cause of death for men and women, and a major cause of serious, long-term disability. The report found that the stroke hospitalization rate for African-Americans was 27 percent higher than for the United States population in general, 30 percent higher than for whites, and 36 percent higher than for Hispanics.

The highest rate of stroke hospitalizations among Medicare beneficiaries exists among African-Americans and in counties located primarily in the southeastern states, according to a new report released by the Centers for Disease Control and Prevention (CDC) in collaboration with the Centers for Medicare and Medicaid Services (CMS).

The report, “Atlas of Stroke Hospitalizations Among Medicare Beneficiaries,” also reveals that a significant number of Medicare beneficiaries live in counties that have no access to care or inadequate choices for emergency health care when they suffer a stroke.

“The atlas highlights that where you live can determine how you live, regarding your ability to take part in activities that reduce your risk of stroke,” said Michele Casper, PhD., lead author of the study and an epidemiologist at the CDC’s Division for Heart Disease and Stroke Prevention. “Examples of community conditions that can influence a person’s risk for stroke include the availability of affordable healthy food, safe options for physical activity, access to high quality health care, and anti-smoking legislation and policies.”

The atlas shows that approximately 21 percent of counties did not have a hospital at all, 31 percent lacked a hospital with an emergency department, and 77 percent did not have a hospital with neurology services.

“With this information, we can target our quality initiatives and payment reform proposals to address the variations identified, and focus more attention on the needs of underserved Medicare populations.”
For all types of strokes, including those caused by a blockage to a blood vessel in the brain, and those caused by a ruptured blood vessel, the maps show that counties with the highest rates are located primarily in the southeastern states, including Alabama and Louisiana. Among people hospitalized for stroke, Medicare beneficiaries in the southeastern states were also most likely to be diagnosed with high blood pressure or diabetes ? both risk factors for stroke.

“This atlas is a great tool for health professionals at the local, state, and national levels as they design and implement programs to eliminate geographic and racial/ethnic disparities in stroke hospitalizations among Medicare beneficiaries,’ said Darwin Labarthe, M.D., M.P.H., Ph.D., director, CDC’s Division for Heart Disease and Stroke Prevention.

Copies of the atlas are available free from the National Center for Chronic Disease Prevention and Health Promotion, Division for Heart Disease and Stroke Prevention, N.E., Mail Stop K-47, Atlanta, Georgia 30341-3724 or by calling 1-888-232-2306. An interactive version of the atlas is available at http://apps.nccd.cdc.gov/giscvh2. To download sections of the atlas, visit www.cdc.gov/dhdsp.

Do Not to Use “Blue Steel” and “Hero” Products 3-31-2008

These products are illegal drugs and pose serious health risks.

The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products marketed as dietary supplements throughout the United States because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level.

These products are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. They’re touted as “all natural” and labeled as dietary supplements. However, Blue Steel and Hero products do not qualify as dietary supplements because they contain undeclared and unapproved substances that are similar in chemical structure to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED.

Singulair 3-30-2008

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.

Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).

In February 2008, FDA and Merck discussed how best to communicate these labeling changes to prescribers and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and provide prescribers with patient information leaflets about Singulair. The Singulair website includes the most current prescribing information and patient information for Singulair (www.singulair.com).

FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.

Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

The FDA urges both healthcare professionals and patients to report side effects from the use of Singulair, Accolate, Zyflo, and Zyflo CR to the FDA's MedWatch Adverse Event Reporting program

Griffin P. Rodgers, M.D., Director, National Institute of Diabetes and Digestive and Kidney Diseases for National Kidney Month

Kidney disease is common, serious and treatable. Yet, most of the 26 million Americans who have kidney problems still don't know it because they don't have symptoms, hampering efforts to prevent kidney failure. While World Kidney Day 2008 has passed and National Kidney Month is well under way, here at the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health, we continue to hear from people about kidney health. We remain strong in our commitment to support research and to raise awareness about important steps people can take to protect their kidneys.

If you have diabetes, high blood pressure, heart disease, vascular disease, or kidney disease in the family, you are at risk for kidney problems. Blood and urine tests are the only way to find the disease early, when treatment is more likely to significantly delay or prevent kidney failure. To help protect the kidneys, I urge you to carefully control high blood pressure — and blood sugar if you have diabetes — and ask your doctor if you should take an ACE (angiotensin-converting enzyme) inhibitor or ARB (angiotensin receptor blocker).

No one is immune from kidney disease. It does not have a season. It strikes children and adults and people of all races and ethnicities. It runs in families, disproportionately affecting African Americans and Native Americans. Kidney disease can lead to kidney failure, premature death, heart attacks, strokes, bone disease, and growth and development problems in children. Diabetes and high blood pressure are the top causes of kidney problems, but kidney disease is also caused by glomerulonephritis, polycystic kidney disease, focal segmental glomerulosclerosis, and vesicoureteral reflux.

NIH research has shown that more people are getting kidney disease and kidney failure every day. Treatment advances and the increase in diabetes and in the U.S. population — and the graying and growing girth of our population — means more people than ever are getting and living with kidney problems. Chronic kidney disease now affects about 13 percent of the U.S. population, up from 10 percent in 1994. And in 2005, more than 485,000 people were on chronic dialysis or had a kidney transplant for kidney failure, costing Medicare, private insurers and patients $32 billion.

At NIH, our timeless commitment to vigorous medical research has improved patient care and, in the 2007 budget year alone, this agency made a $450 million investment in advances of the future. Past NIDDK-supported clinical studies established that tight glucose control and ACE inhibitors prevent or slow kidney disease and other complications of diabetes. Current NIDDK programs are adding to ever-increasing knowledge of kidney disease — from basic research to understand the underpinnings of healthy and diseased kidneys to clinical research involving patients, and from children to adults.

Ongoing studies include a trial of magnetic resonance imaging to monitor polycystic kidney disease, more frequent dialysis for kidney failure, and treatment studies for polycystic kidney disease, glomerulosclerosis and vesicoureteral reflux in children.

In line with our mission, NIDDK's National Kidney Disease Education Program (www.nkdep.nih.gov) aims to improve early detection and broaden the use of available treatments. Through this ambitious program, we ask labs to automatically report estimated kidney function (eGFR) to find the disease earlier and to use standardized kidney tests, and we offer time-saving tools to improve communication between kidney specialists and primary care physicians. Visit our Web site to learn about other NKDEP activities and information available for people at risk and for the health professionals who care for them.

TB Progress

3-20 MARCH 2008 | GENEVA -- The Global tuberculosis control 2008, released today by WHO, finds that the pace of the progress to control the tuberculosis (TB) epidemic slowed slightly in 2006, the most recent year for which data were available. The new information documents a slowdown in progress on diagnosing people with TB. Between 2001 to 2005, the average rate at which new TB cases were detected was increasing by 6% per year; but between 2005 and 2006 that rate of increase was cut in half, to 3%.

Topical overview: tuberculosis
The reason for this slowing of progress is that some national programmes that were making rapid strides during the previous five years have been unable to continue at the same pace in 2006. Moreover, in most African countries there has been no increase in the detection of TB cases through national programmes. Other studies have also shown that many patients are treated by private care providers, and by non-governmental, faith-based and community organizations, thus escaping detection by the public programmes.

"We've entered a new era," said Dr Margaret Chan, WHO Director-General. "To make progress, firstly public programmes must be further strengthened. Secondly, we need to fully tap the potential of other service providers. Enlisting these other providers, working in partnership with national programmes, will markedly increase diagnosis and treatment for people in need."

This is the 12th annual WHO report on global TB control, and is based on data given to WHO by 202 countries and territories. There were 9.2 million new cases of TB in 2006, including 700 000 cases among people living with HIV, and 500 000 cases of multi-drug resistant TB (MDR-TB). An estimated 1.5 million people died from TB in 2006. In addition, another 200 000 people with HIV died from HIV-associated TB.

FDA Takes Next Step in Establishing Overseas Presence in China 3-18-2008

In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.

This is an important step forward in the FDA's plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

"In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters," said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. "Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market."

FDA Issues Alert on Tussionex,for Chldren and Adults

The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events--including death--associated with the misuse and inappropriate use of this potent cough medication.
Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours
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“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” said Curtis Rosebraugh, M.D., M.P.H., acting director of the FDA's Office of Drug Evaluation II. “Today’s action is an example of the FDA working with drug manufacturers throughout a product’s lifecycle to keep health care professionals and patients informed of new safety data.”

Adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children. These reports reveal physicians and other health professionals are sometimes prescribing, and patients are sometimes taking, more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved.

 

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