A Little Belly Fat Can Double the Risk of Death in Coronary Artery Disease Patients

(BUSINESS WIRE)--One of the largest studies of its kind has found that people with coronary artery disease who have even a modest beer belly or muffin top are at higher risk for death than people whose fat collects elsewhere. The effect was observed even in patients with a normal Body Mass Index (BMI). The findings of this Mayo Clinic analysis are published in the May 10 issue of the Journal of the American College of Cardiology.

Researchers analyzed data from 15,923 people with coronary artery disease involved in five studies from around the world. They found that those with coronary artery disease and central obesity, measured by waist circumference and waist-to-hip ratio, have up to twice the risk of dying. That is equivalent to the risk of smoking a pack of cigarettes per day or having very high cholesterol, particularly for men.

The findings refute the obesity paradox, a puzzling finding in many studies that shows that patients with a higher BMI and chronic diseases such as coronary artery disease have better survival odds than normal-weight individuals.

“We suspected that the obesity paradox was happening because BMI is not a good measure of body fatness and gives no insight into the distribution of fat,” says Thais Coutinho, M.D., the study’s lead author and a cardiology fellow at Mayo Clinic. “BMI is just a measure of weight in proportion to height. What seems to be more important is how the fat is distributed on the body,’’ she says.

Francisco Lopez-Jimenez, M.D., the project’s lead investigator and director of the Cardiometabolic Program at Mayo Clinic, explains why this type of fat may be more harmful: “Visceral fat has been found to be more metabolically active. It produces more changes in cholesterol, blood pressure and blood sugar. However, people who have fat mostly in other locations in the body, specifically, the legs and buttocks, don’t show this increased risk.”

The researchers say physicians should counsel coronary artery disease patients who have normal BMIs to lose weight if they have a large waist circumference or a high waist-to-hip ratio. The measure is very easy to use, Dr. Coutinho says: “All it takes is a tape measure and one minute of a physician’s time to measure the perimeter of a patient’s waist and hip.”

The research subjects were diverse, coming from studies in the U.S. (Rochester, Minn. and San Francisco, Calif.), Denmark, France and Korea. The inclusion of different ethnic groups makes the study more applicable to the real world, Dr. Coutinho says.

Other members of the research team are Kashish Goel, M.D.; Daniel Correa de Sa, M.D.; Randal Thomas, M.D.; Veronique Roger, M.D., MPH; and Virend Somers, M.D., Ph.D., of Mayo Clinic; Charlotte Kragelund, M.D., Ph.D.; Lars Kober, M.D., Ph.D.; and Christian Torp-Pedersen, M.D., Ph.D., from Rigshaspitalet, Copenhagen, Denmark; Alka Kanaya, M.D. of the University of California, San Francisco, California; Jong-Seon Park, M.D.; Sang-Hee Lee, M.D.; and Young-Jo Kim, M.D., of Yeungnam University Hospital, Daegu, Korea; and Yves Cottin, M.D., Ph.D.; and Luc Lorgis, M.D., from CHU Bocage, Dijon, France.

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Stroke Drops to Fourth Leading Cause of Death in 2008

/PRNewswire/ -- Stroke is now the fourth leading cause of death in the United States, down from the third place ranking it has held for decades, according to preliminary 2008 death statistics released today by CDC's National Center for Health Statistics. While deaths from stroke and several other chronic diseases are down, deaths due to chronic lower respiratory disease increased in 2008.

There were 133,750 deaths from stroke in 2008. Age-adjusted death rates from stroke declined 3.8 percent between 2007 and 2008. Meantime, there were 141,075 deaths from chronic lower respiratory disease, and the death rate increased by 7.8 percent.

Some of the increase in deaths may be due to a modification made by the World Health Organization in the way deaths from chronic lower respiratory diseases are classified and coded. The National Center for Health Statistics will conduct a thorough analysis on this change and its effect on the chronic lower respiratory disease category before the final 2008 deaths data are released.

"Deaths: Preliminary Data for 2008," also finds that life expectancy at birth dropped slightly to 77.8 years from 77.9 years in 2007. Life expectancy was down by one-tenth of a year (a little over a month) for both men and women. However, black males had a record high life expectancy in 2008 of 70.2 years – up from 70 years in 2007. The life expectancy gap between the white and black populations was 4.6 years in 2008, a decrease of two-tenths of a year from 2007.

The data are based on 99 percent of death certificates reported to NCHS through the National Vital Statistics System from all 50 states, the District of Columbia and U.S. territories.

Other findings:

* Heart disease and cancer, the two leading causes of death, still accounted for nearly half (48 percent) of all deaths in 2008.
* In addition to stroke, mortality rates declined significantly for five of the other 15 leading causes of death: accidents/unintentional injuries (3.5 percent), homicide (3.3 percent), diabetes (3.1 percent), heart disease (2.2 percent), and cancer (1.6 percent).
* In addition to chronic lower respiratory disease, death rates increased significantly in 2008 for Alzheimer's disease (7.5 percent), influenza and pneumonia (4.9 percent), high blood pressure (4.1 percent), suicide (2.7 percent), and kidney disease (2.1 percent).
* The preliminary infant mortality rate for 2008 was 6.59 infant deaths per 1,000 live births, a 2.4 percent decline from the 2007 rate of 6.77 and an all-time record low. Birth defects were the leading cause of infant death in 2008, followed by disorders related to preterm birth and low birth weight. Sudden infant death syndrome (SIDS) was the third leading cause of infant death in the United States.
* Overall, there were 2,473,018 deaths in the United States in 2008, according to the preliminary deaths report -- 49,306 more deaths than the 2007 total.
* The age-adjusted death rate for the U.S. population fell to 758.7 deaths per 100,000 in 2008 compared to the 2007 rate of 760.2.

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Study Compares Risk With Two Diabetes Drugs

/PRNewswire/ -- In contrast to previous reports, the risks of the composite endpoint of heart attack, heart failure, both, or death were the same - about 4 percent - for patients taking the diabetes drugs rosiglitazone or pioglitazone, according to a study published in the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes.

"This study provides patients and their doctors with another source of information about rosiglitazone and pioglitazone (sold as Avandia and Actos, respectively) as they determine the best therapy for diabetes patients," said Debra Wertz, Pharm.D., lead author and outcomes research manager at HealthCore, Inc., the research subsidiary of health insurance company WellPoint, Inc.

This study evaluated more than 36,000 diabetes patients. Of the 28,938 patients who were propensity-score matched, a methodology used to provide an estimation of treatment-effects that is as unbiased as possible, 602 patients taking rosiglitazone and 599 taking pioglitazone over a 33-month period suffered either a heart attack, heart failure, both, or died. This translates to about 4 percent of all patients taking either medication. The individual specific adverse events were also not significantly different between the two groups, and were:

-- Heart attack - 96 patients on rosiglitazone and 121 patients on
pioglitazone;
-- Heart failure - 265 patients taking rosiglitazone and 243 taking
pioglitazone;
-- Heart attack and heart failure - 24 patients on rosiglitazone and 18
on pioglitazone; and
-- Death - 217 patients taking rosiglitazone and 217 taking pioglitazone.


The study included 36,628 patients who had submitted insurance claims to WellPoint affiliates for either of the two diabetes medications between 2001 and 2005. Patients' average age was 54, and 58 percent were male. Wertz and her team obtained death records from the National Death Index, a central database administered by the National Center for Health Statistics.

The investigators divided patients into two equal groups, one receiving rosiglitazone and the other, pioglitazone. After adjusting the data for (removing/minimizing the effect of) age, gender, prior heart and blood vessel diseases and diabetes-related complications and severity indicators, they compared the incidence of heart attack, heart failure and death for an average 14 months of treatment and 19 months of post-treatment follow-up.

Diabetes is a disease in which the body cannot adequately produce the hormone insulin or uses it improperly. The disease can cause a potentially dangerous buildup of sugar in the blood and also increases the risk of heart and blood vessel diseases, which are the main causes of death for people with diabetes.

Rosiglitazone, sold under the trade name Avandia by GlaxoSmithKline, and pioglitazone, sold as Actos by Takeda Pharmaceuticals, belong to the same class of drugs, called TZDs or thiazolidinediones. They help the body use insulin more effectively by boosting the body's sensitivity to the hormone and thus help control blood sugar.

This study has results different from earlier ones that found a greater risk of heart attack among rosiglitazone users compared to patients on other treatments or placebo. In 2007, the Food and Drug Administration decided that the benefits of rosiglitazone outweighed the risks, and it remained on the market although its use decreased significantly. In July 2010, an FDA advisory committee again reviewed numerous studies, including this study, and recommended that rosiglitazone remain on the market, although with additional warnings or restrictions. The FDA has not yet ruled on this latest recommendation.

"Besides its findings that rosiglitazone and pioglitazone have comparable risks, what distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths," Wertz said. The study also followed patients for a longer period of time than some of the earlier research, according to the investigators.

"One of the reasons we embarked on this analysis was to see if there were any differences in effect that we could identify between these two agents," said Mark J. Cziraky, Pharm.D., study co-author, and vice president of research development and operations at HealthCore. "We did not find that with the approach and methods we took within this population."

Other co-authors are Chun-Lan Chang, Ph.D.; Chaitanya A Sarawate, M.S.; Vincent J. Willey, Pharm.D.; and Rhonda L. Bohn, M.P.H., Sc.D.

Author disclosures are on the manuscript. WellPoint, Inc. funded this research.


An accompanying editorial, "Improving Surveillance for Drug Safety: Lessons from Rosiglitazone," by Frederick A Masoudi, M.D., M.S.P.H., is available.


Statements and conclusions of study authors published in American
Heart Association scientific journals are solely those of the study
authors and do not necessarily reflect the association's policy or
position. The association makes no representation or guarantee as to
their accuracy or reliability. The association receives funding
primarily from individuals; foundations and corporations (including
pharmaceutical, device manufacturers and other companies) also make
donations and fund specific association programs and events. The
association has strict policies to prevent these relationships from
influencing the science content. Revenues from pharmaceutical and
device corporations are available at http://www.americanheart.org/
corporatefunding.

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Low Production of Serotonin in the Brainstem a Likely Cause for SIDS

/PRNewswire/ -- Taking the next step in more than 20 years of research, researchers at Children's Hospital Boston have linked sudden infant death syndrome (SIDS) with low production of serotonin in the brainstem, based on a comparison of brainstem samples from infants dying of SIDS compared to brainstems of infants dying from other, known causes.

The findings, published in the Feb. 3 issue of The Journal of the American Medical Association, may give a concrete approach to identifying babies at risk for SIDS, the leading cause of death for infants between 1 and 12 months old in the United States.

In the brainstem, serotonin helps regulate some of the body's involuntary actions, such as breathing, heart rate and blood pressure during sleep. The researchers, led by Children's neuropathologist Hannah Kinney, MD, believe that a low serotonin level impairs the function of the brainstem circuits that regulate these activities, putting a baby at risk for sudden death from stresses such as rebreathing carbon dioxide when sleeping in the face down position.

The future goal of this work is to devise a test to identify infants with a serotonin brainstem defect early, and to develop preventive treatments that would correct the serotonin deficiency.

In 2006, Kinney and colleagues showed that SIDS is associated with abnormalities in the number of cells and receptors related to serotonin in the brainstem, but it wasn't clear whether SIDS may be caused by overproduction or underproduction of the chemical.

In the new study, the team measured the levels of serotonin and tryptophan hydroxylase, the enzyme that helps make serotonin, in 35 infants dying from SIDS and two control groups (5 infants dying acutely from other causes, and 5 hospitalized infants with chronic hypoxia-ischemia (insufficient oxygen supply to tissues). Tissue samples from the brainstem were obtained from autopsies and provided by research partners at the San Diego County Medical Examiner's Office in California.

Compared with controls, the serotonin levels in the lower brainstem were 26 percent lower in the SIDS cases compared to controls, while the tryptophan hydroxylase levels were 22 percent lower. Levels of binding to serotonin receptors were also lower by more than 50 percent. The consistency and correlation of these findings with each other reinforce the idea that SIDS in the majority of cases is a disorder of serotonin the brainstem, the researchers say.

"The baby looks normal during the day; there's nothing that would tell you that baby is going to die of SIDS that night," says Kinney, who has studied SIDS for more than 20 years. "There's something about sleep that unmasks the defect, which we believe is in serotonin circuits: the baby experiences some kind of stress during sleep, such as rebreathing carbon dioxide in the face-down position or increased temperature from over-bundling, that cannot be compensated for by the defective brainstem circuits, and the baby then goes on to die."

In a normal baby rebreathing carbon dioxide, serotonin pathways in the brainstem would stir the baby awake long enough to turn its head, allowing it to breathe fresh air, Kinney adds. A baby with low serotonin levels in the brainstem may never stir.

SIDS has puzzled doctors and families for decades, but once the medical community recognized that a baby's position while sleeping affects the risk for SIDS, national awareness campaigns sprouted to persuade parents to place babies to sleep on their backs. However, such campaigns haven't completely solved the problem, prompting ongoing research to find a biological component to SIDS.

While this study provides strong evidence for a biological cause of SIDS, it also shows that other risk factors, such as sleeping on one's stomach, can aggravate the risk. Of the SIDS infants in the current study, 95 percent died with at least one risk factor, and 88 percent died with at least two.

The next step in this research is to find out what causes abnormally low serotonin levels in the first place. Genetic variations may be partly responsible, says neuroscientist David Paterson, PhD, in Kinney's lab, a contributing author of the paper. Kinney's lab is searching for such variations.

In the meantime, parents should remove unnecessary SIDS risk factors, Kinney says. During pregnancy, there is no safe level of alcohol a mother can drink and no safe level of smoking, both firsthand and secondhand. Until 12 months of age, babies should sleep on their backs in a crib with a firm mattress, and without toys, soft pillows, excessive blanketing or excessive clothing.

This study was supported by funds from the First Candle/SIDS Alliance, CJ Martin Overseas Fellowship, the CJ Murphy Foundation for Solving the Puzzle of SIDS, CJ Foundation for SIDS, the National Institute of Child Health and Development, and the Developmental Disabilities Research Center at Children's Hospital Boston.

Citation: Jhodie R. Duncan, PhD, David S. Paterson, PhD, Jill M. Hoffman, BS, David J. Mokler, PhD, Natalia S. Borenstein, MS, Richard A. Belliveau, BA, Henry F. Krous, MD, Elisabeth A. Haas, BA, Christina Stanley, MD, Eugene E. Nattie, MD, Felicia L. Trachtenberg, PhD, Hannah C. Kinney, MD. Brainstem serotonergic deficiency in Sudden Infant Death Syndrome. JAMA Feb. 3, 2010, Vol. 303, No. 5.

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Life Expectancy at All Time High; Death Rates Reach New Low, New Report Shows

U.S. life expectancy reached nearly 78 years (77.9), and the age-adjusted death rate dropped to 760.3 deaths per 100,000 population, both records, according to the latest mortality statistics from the Centers for Disease Control and Prevention (CDC).

The report, "Deaths: Preliminary Data for 2007," was issued today by CDC's National Center for Health Statistics. The data are based on nearly 90 percent of death certificates in the United States.

The 2007 increase in life expectancy - up from 77.7 in 2006 -- represents a continuation of a trend. Over a decade, life expectancy has increased 1.4 years from 76.5 years in 1997 to 77.9 in 2007.

Other findings:

* Record high life expectancy was recorded for both males and females (75.3 years and 80.4 years, respectively). While the gap between male and female life expectancy has narrowed since the peak gap of 7.8 years in 1979, the 5.1 year difference in 2007 is the same as in 2006.

* For the first time, life expectancy for black males reached 70 years.

* The U.S. mortality rate fell for the eighth straight year to an all-time low of 760.3 deaths per 100,000 population in 2007 -- 2.1 percent lower than the 2006 rate of 776.5. The 2007 mortality rate is half of what it was 60 years ago (1532 per 100,000 in 1947.)

* The preliminary number of deaths in the United States in 2007 was 2,423,995, a 2,269 decrease from the 2006 total.

* Heart disease and cancer, the two leading causes of death, accounted for nearly half (48.5 percent) of all deaths in 2007.

* Between 2006 and 2007, mortality rates declined significantly for eight of the 15 leading causes of death. Declines were observed for influenza and pneumonia (8.4 percent), homicide (6.5 percent), accidents (5 percent), heart disease (4.7 percent), stroke (4.6 percent), diabetes (3.9 percent), hypertension (2.7 percent), and cancer (1.8 percent).

* The death rate for the fourth leading cause of death, chronic lower respiratory diseases, increased by 1.7 percent. Preliminary death rates also increased for Parkinson's disease, chronic liver disease and cirrhosis, and Alzheimer's, but these gains are not statistically significant.

* There were an estimated 11,061 deaths from HIV/AIDS in 2007, and mortality rates from the disease declined 10 percent from 2006, the biggest one-year decline since 1998. HIV remains the sixth leading cause of death among 25-44 year-olds.

* The preliminary infant mortality rate for 2007 was 6.77 infant deaths per 1,000 live births, a 1.2 percent increase from the 2006 rate of 6.69, though not considered statistically significant. Birth defects were the leading cause of infant death in 2007, followed by disorders related to preterm birth and low birthweight. Sudden infant death syndrome (SIDS) was the third leading cause of infant death in the United States.

The full report is available at www.cdc.gov/nchs.
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Study Says Pregnant Women Are More Severely Impacted by Novel H1N1 Influenza Virus

Pregnant women infected with 2009 novel H1N1 had a higher rate of hospitalization and greater risk of death than the general population due to the H1N1 flu, according to a study in the Aug. 8 issue of the British medical journal Lancet.

The data collected and analyzed by the Centers for Disease Control and Prevention (CDC) are the most comprehensive available to date on the impact of this novel H1N1 flu virus among pregnant women.

"The death of a pregnant woman is always heartbreaking, and unfortunately we have been hearing reports of otherwise healthy women dying from H1N1. If a pregnant woman feels like she may have influenza, she needs to call her healthcare provider right away," said CDC’s Dr. Denise Jamieson, lead author of the study. “Clinicians who treat pregnant women should have a system in place for triaging pregnant women with influenza-like symptoms and they should not delay in initiating appropriate antiviral therapy. Some clinicians hesitate treating pregnant women with antiviral medications because of concerns for the developing fetus, but this is the wrong approach. It is critical that pregnant women, in particular, be treated promptly. "

Six deaths of pregnant women with H1N1 were reported to CDC between April 15 and June 16, 2009, representing 13 percent of the total 45 deaths reported to CDC during that time period. All were healthy prior to infection of H1N1 and subsequently developed primary viral pneumonia leading to acute respiratory distress requiring mechanical ventilation. All pregnant women who died did not receive antivirals soon enough to benefit their treatment. CDC recommends that pregnant women with suspected or confirmed influenza infection receive prompt treatment with antiviral medication.

Based on past influenza pandemics and on seasonal influenza epidemics, pregnant women have increased rates of illness and death from influenza infection.

Despite recommendations from the Advisory Committee on Immunization Practices and the American College of Obstetricians and Gynecologists for inactivated flu vaccine for all pregnant women, seasonal flu vaccine coverage among pregnant women is very low (less than 14 percent).

CDC has posted clinical guidance for treatment and prophylaxis of pregnant women with suspected or confirmed pandemic H1N1 2009 influenza at http://www.cdc.gov.h1n1flu/clinician_pregnant.htm.
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FDA Warns Consumers to Stop Using Hydroxycut Products

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.

Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

–Online: www.fda.gov/MedWatch/report.htm
–Regular Mail: Use FDA postage paid form 3500 found at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
–Fax: 800-FDA-0178
–Phone: 800-FDA-1088

The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

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FDA Announces Class I Recalls of Two Unapproved Devices

The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.

The manufacturers, VIBE Technologies of Greeley, Colo., and Nebion LLC of Los Angeles, Calif., claimed their devices treated conditions ranging from cancer to migraines. The FDA is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.

"These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "One of the FDA's primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process.”
Vibrational Integrated Bio-photonic Energizer device

On April 11, 2008, the FDA issued a warning letter to VIBE Technologies stating that the agency's November 2007 inspection of the facility showed that the company had not obtained FDA marketing approval or clearance for the Vibrational Integrated Bio-photonic Energizer (VIBE device), which claims to treat cancer, infections, and depression. The FDA also cited the company for substantial deviations from the current Good Manufacturing Practice/Quality System regulation.

VIBE Technologies initiated a recall of 840 VIBE devices in an April 3, 2008, letter sent to users. VIBE Technologies agreed to stop promoting and marketing the VIBE device, and will contact all those who had purchased it to ensure no other unsubstantiated medical claims are being made. The FDA has requested that the company update its recall notices to state that the VIBE device is not intended for the treatment of any diseases or medical conditions.

The FDA is aware of information that suggests that the VIBE device has been used in cancer patients. There is one death that occurred in a patient who used this device. However, FDA has not verified that there is any association between the death and the VIBE device.
HLX8 device

In June 2008 FDA inspected Nebion, LLC, which revealed that the company had not obtained FDA marketing approval or clearance for the HLX8 device, which claims to treat cancer, migraines, arthritis, and ruptured discs. The inspection also uncovered substantial deviations from the Current Good Manufacturing Practice/Quality System regulation.

Nebion recalled eight HLX8 devices on July 2, 2008, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval.

Nebion's first recall letter did not address the potential risks associated with the HLX8 device, but the company has recently notified FDA that they will issue a second letter that identifies potential health hazards. The FDA has not received any reports of injuries or deaths linked with the HLX8 device.

Under federal law, products that claim to diagnose a disease or condition, cure, mitigate, treat or prevent disease, or that are intended to affect the structure or function of the body are devices subject to FDA jurisdiction and may require FDA approval or clearance prior to marketing. Premarket approval is the most stringent type of FDA device review and is for devices with a high level of risk, such as those that support or sustain human life. FDA clearance is for lower risk devices that are shown to be as safe and effective as a similar device already on the market.

Neither VIBE Technologies nor Nebion has demonstrated to the FDA that their device is safe and effective at curing or treating diseases as claimed.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088

Health care professionals and patients can obtain further details about the recalls from VIBE Technologies at 970-356-9594 or Nebion LLC, at 310-215-6400.

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Global Measles Deaths Drop By 74%

/PRNewswire-USNewswire/ -- Measles deaths worldwide fell by 74% between 2000 and 2007, from an estimated 750,000 to 197,000. In addition, the Eastern Mediterranean region* which includes countries such as Afghanistan, Pakistan, Somalia, and the Sudan has cut measles deaths by a remarkable 90% -- from an estimated 96,000 to 10,000 -- during the same period, thus achieving the United Nations goal to reduce measles deaths by 90% by 2010, three years early.

The progress was announced today by the founding partners of the Measles Initiative: the American Red Cross, the United States Centers for Disease Control and Prevention (CDC), the United Nations Foundation (UN Foundation), UNICEF and the World Health Organization (WHO). The data will be published in the 5 December edition of WHO's Weekly Epidemiological Record and CDC's Morbidity and Mortality Weekly Report.

"This achievement is a tribute to the hard work and commitment of countries in the Eastern Mediterranean region to combat measles," said Dr Margaret Chan, WHO Director-General. "With only two years until the 2010 target date, I urge all countries affected by measles to intensify their efforts to immunize all children against the disease."

The significant decline in measles deaths in the Eastern Mediterranean region was the result of intensified vaccination campaigns including several countries with hard-to-reach areas. In 2007, more than twice the number of children were immunized in the region through such campaigns as compared to 2006.

"There are thousands of health workers and volunteers from our Red Cross and Red Crescent family who deserve much of the credit for this success. They give their time to literally go door-to-door informing, educating and motivating mothers and caregivers about the critical need to vaccinate their children," said Bonnie McElveen-Hunter, Chairman of the Board of the American Red Cross. "This mobilization helps us to consistently reach more than 90% of the vulnerable population and save countless lives."

The African region was the largest contributor to the global decline in measles deaths, accounting for about 63% of the reduction in deaths worldwide over the eight-year period. In 2007, measles outbreaks occurred in a number of African countries due to gaps in immunization coverage, reinforcing the need to continue immunization support.

"It's absolutely wonderful that so many children are off to a healthy start in life thanks to the progress we've made in combating measles through immunization," said Dr. Julie Gerberding, CDC Director. "Other children's lives are still at risk, however, so it's time we refocus our attention on sustaining our immunization efforts in countries where rates are low."

The progress in South-East Asia has been limited -- with just a 42% decline in measles deaths. This is due to the delayed implementation of large-scale vaccination campaigns in India, which currently accounts for two thirds of global measles deaths. Political commitment in India is essential if the 2010 global goal is to be achieved.

"The progress that has been made shows what can be achieved through measles vaccination campaigns, but much more needs to be done," said Ann M. Veneman, Executive Director of UNICEF. "It is a tragedy that measles still kills more than 500 children a day when there is a safe, effective and inexpensive vaccine to prevent the disease."

The world's success in reaching the 2010 measles goal depends on ensuring that all children receive two doses of measles vaccine including one dose by their first birthday, strengthening disease surveillance systems, and providing effective treatment for measles.

"Progress also depends on addressing the considerable funding gap," said Kathy Calvin, Executive Vice President and Chief Operating Officer for the UN Foundation. "The shortfall stands at US $176 million for 2009-2010, of which US $35 million is urgently needed for 2009. With continued funding and increasing ownership and commitment of countries, we can sustain our progress and achieve our goal by 2010. We ask our supporters to stay with us and strongly encourage new supporters to join us in our effort to save lives."

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Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System

Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.

Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.

Thoratec is voluntarily issuing an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. In five cases, pump replacement was not feasible and the patients expired.

The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.

Hospitals are being sent an Urgent Medical Device Correction letter identifying the probability and symptoms of the problem, and recommending that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. Hospitals are also requested to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instructions if they do not receive the Medical Device Correction letter. The labeling for the HeartMate II LVAS will be revised with the updated risk information related to percutaneous lead damage. Copies of this press release may be found on Thoratec’s website, www.thoratec.com, under Investor Relations/Press Releases.

Clinicians and patients with questions may contact the company at 1-800-528-2577, or if calling from outside the USA, 1-925-847-8600 (7 days a week, 8-5 Pacific Time).

FDA has been informed of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787
• Fax: 1-800-FDA-0178

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Poor Perioperative Blood Pressure Control Linked to 30-Day Morbidity and Mortality in Cardiac Surgery Patients

Business Wire - The Medicines Company (NASDAQ: MDCO) announced October 21, 2008, that poor blood pressure control during cardiac surgery is associated with a higher risk of 30-day death, stroke, myocardial infarction and renal dysfunction, compared to patients with tight blood pressure control, according to a post-hoc analysis of the ECLIPSE trial. The data were presented at the American Society of Anesthesiologists (ASA) 2008 Annual Meeting.

“In this analysis, what we found was clear: the worse the blood pressure control, the poorer the outcome in these cardiac surgery patients,” said Solomon Aronson, M.D., Professor of Anesthesiology, Duke University School of Medicine. “These data support the need to more effectively manage blood pressure in the surgical and critical care settings.”

The ECLIPSE trial enrolled 1,964 cardiac surgery patients in one of three randomized, open-label trials comparing Cleviprex™ (clevidipine butyrate) injectable emulsion to nitroglycerin, sodium nitroprusside or nicardipine. In this post-hoc analysis, 1507 ECLIPSE patients were stratified by precision of blood pressure control measured as excursions and time out of a pre-specified range. Adverse outcomes, assessed as death, myocardial infarction, stroke and renal dysfunction at 30 days post-discharge, were significantly higher in patients with poor blood pressure control (14.4%) than in patients with tight blood pressure control (8.8%).

“These critical new findings underscore the risk posed by uncontrolled blood pressure during cardiac surgery and emphasize the need for tight blood pressure control in these patients,” said James Ferguson, M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company. “Cleviprex, recently approved by the FDA, provides physicians with an important, new clinical tool for achieving rapid and predictable blood pressure control.”

Additional post-hoc data from the pivotal ECLIPSE program, involving patients undergoing cardiac valve surgery, will be presented at the American College of Chest Physicians (ACCP) annual meeting in Philadelphia on Tuesday, October 28, 2008.

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Low Vitamin D Levels Pose Large Threat to Health

Researchers at Johns Hopkins are reporting what is believed to be the most conclusive evidence to date that inadequate levels of vitamin D, obtained from milk, fortified cereals and exposure to sunlight, lead to substantially increased risk of death.

In a study set to appear in the Archives of Internal Medicine online Aug. 11, the Johns Hopkins team analyzed a diverse sample of 13,000 initially healthy men and women participating in an ongoing national health survey and compared the risk of death between those with the lowest blood levels of vitamin D to those with higher amounts. An unhealthy deficiency, experts say, is considered blood levels of 17.8 nanograms per milliliter or lower.

Of the 1,800 study participants known to have died by Dec. 31, 2000, nearly 700 died from some form of heart disease, with 400 of these being deficient in vitamin D. This translates overall to an estimated 26 percent increased risk of any death, though the number of deaths from heart disease alone was not large enough to meet scientific criteria to resolve that it was due to low vitamin D levels.

Yet, researchers say it does highlight a trend, with other studies linking shortages of vitamin D to increased rates of breast cancer and depression in the elderly. And earlier published findings by the team, from the same national study, have established a possible tie-in, showing an 80 percent increased risk of peripheral artery disease from vitamin D deficits.

Researchers note that other studies in the last year or so in animals and humans have identified a connection between low levels of vitamin D and heart disease. But these studies, they say, were weakened by small sample numbers, lack of diversity in the population studied and other factors that limited scientists’ ability to generalize the findings to the public at large.

“Our results make it much more clear that all men and women concerned about their overall health should more closely monitor their blood levels of vitamin D, and make sure they have enough,” says study co-lead investigator Erin Michos, M.D., M.H.S.

“We think we have additional evidence to consider adding vitamin D deficiency as a distinct and separate risk factor for death from cardiovascular disease, putting it alongside much better known and understood risk factors, such as age, gender, family history, smoking, high blood cholesterol levels, high blood pressure, lack of exercise, obesity and diabetes,” says Michos. Vitamin D is well known to play an essential role in cell growth, in boosting the body’s immune system and in strengthening bones.

“Now that we know vitamin D deficiency is a risk factor, we can better assess how aggressively to treat people at risk of heart disease or those who are already ill and undergoing treatment,” says Michos, who adds that test screening for nutrient levels is relatively simple. It can, she says, be made part of routine blood work and done while monitoring other known risk factors, including blood pressure, glucose and lipid levels.

Heart disease remains the nation’s leading cause of death, killing more than a million Americans each year. Nearly 10 percent of those with the condition have not one identifiable, traditional risk factor, which the experts say is why a considerable extent of the disease goes unexplained.

Michos, an assistant professor at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute, recommends that people boost their vitamin D levels by eating diets rich in such fish as sardines and mackerel, consuming fortified dairy products, taking cod-liver oil and vitamin supplements, and in warmer weather briefly exposing skin to the sun’s vitamin-D producing ultraviolet light.

Aware of the cancer risks linked to too much time spent in the sun, she says as little as 10 to 15 minutes of daily exposure to the sun can produce sufficient amounts of vitamin D to sustain health. The hormone-like nutrient controls blood levels of calcium and phosphorus, essential chemicals in the body.

If vitamin supplements are used, Michos says there is no evidence that more than 2,000 international units per day do any good. Study results show that heart disease death rates flattened out in participants with the highest vitamin D levels (above 50 nanograms per milliliter of blood), signaling a possible loss of the vitamin’s protective effects at too-high doses.

The U.S. Institute of Medicine suggests that an adequate daily intake of vitamin D is between 200 and 400 international units (or blood levels nearing 30 nanograms per milliliter). Previous results from the same nationwide survey showed that 41 percent of men and 53 percent of women are technically deficient in the nutrient, with vitamin D levels below 28 nanograms per milliliter.

Michal Melamed, M.D., M.H.S., study co-lead investigator who started the research as a clinical fellow at Johns Hopkins, says no one knows yet why or how vitamin D’s hormone-like properties may protect the heart, but she adds that there are plenty of leads in the better known links the vitamin has to problems with muscle overgrowth and high blood pressure, in addition to its control of inflammation, which scientists are showing plays a stronger role in all kinds of heart disease. But more research is needed to determine the nutrient’s precise biological action.

Researchers say their next steps are to test various high doses of vitamin D to find out if the nutritional supplementation results in fewer deaths and lower incidence of heart disease, including heart attack or moments of prolonged and severe chest pain.

The team also plans to investigate what biological triggers, such as obesity or hypertension, might offset or worsen the action of vitamin D on heart muscle, or whether vitamin D sets off some other reaction in the heart.

Melamed says that because vitamin D levels are known to fluctuate in direct proportion with daily physical activity, the growing epidemic of obesity and indoor sedentary lifestyles lend more urgency to act on the vitamin D factor.

Funding for this study was provided by the National Institutes of Health, the P.J. Schafer Cardiovascular Research Fund and the Paul Beeson Physician Faculty Scholars in Aging Program. Michos has received previous consulting fees from vitamin D therapeutics manufacturer Abbott Pharmaceuticals. The terms of these arrangements are being managed by the Johns Hopkins University in accordance with its conflict of interest policies.

Besides Michos and Melamed, other Hopkins researchers involved in this study, conducted solely at Hopkins, were Wendy Post, M.D.; and Brad Astor, Ph.D. Melamed is now an assistant professor at the Albert Einstein College of Medicine of Yeshiva University in New York City.

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Making Sudden Cardiac Arrest a National Health Priority: National Medical Association Issues White Paper on Sudden Cardiac Arrest

PRNewswire-USNewswire -- To help change the prevention and treatment paradigm for sudden cardiac arrest (SCA), the National Medical Association (NMA) released a white paper during their 2008 Annual Convention and Scientific Assembly that outlines directives for elevating SCA to a national health priority and bringing it to the forefront of the policy discussion. This white paper, Sudden Cardiac Arrest: Advancing Awareness and Bridging Gaps to Improve Survival, is based on input from more than 50 of the nation's leading cardiac care professionals, government officials and patient advocates during the 2008 SCA Leadership Conference held in April by the NMA.

SCA claims more than 300,000 lives every year -- nearly 1,000 people each day. It is estimated that 95 percent of SCA victims die before reaching a hospital or emergency help, even though nearly 75 percent show signs of a previous heart attack and 80 percent show signs of coronary artery disease.

Dr. Nelson Adams, NMA Immediate Past-President and program chair said, "sudden cardiac arrest is a leading cause of death in the United States. Particularly alarming is that it disproportionately affects African-Americans."

"Disparities in care for patients that are at risk for SCA, as indicated in the rates found among African American women are unacceptable," said newly elected NMA President, Carolyn Barley-Britton, MD.

Thought leaders who contributed to the white paper agreed that a successful change in SCA health outcomes requires continual involvement from community and health leaders, and the vital next step is implementation of programs and policies that will positively impact health outcomes. The white paper's "call to action" summarizes important next steps to make SCA a national health priority, and includes:

  -- Developing clinical performance measures for SCA prevention
 -- Raising awareness of SCA among consumers and healthcare professionals
 -- Increasing professional education on SCA
 -- Encouraging policymakers to establish SCA as a public health priority

-- Creating cultural proficiency in prevention and treatment of SCA to combat health disparities

-- Enlisting insurers to increase support of SCA prevention and treatment in all populations

"Our goal is to raise awareness of the risk of SCA and galvanize healthcare professionals, researchers, patient advocates, policy makers and payors into action to reduce disparities in both primary and secondary prevention of the disease," said Dr. Mohammed Ahkter, Executive Director of the NMA.

About Sudden Cardiac Arrest

Sudden cardiac arrest is an abrupt loss of heart function (cardiac arrest). All known heart diseases can lead to cardiac arrest and sudden cardiac death. Most of the cardiac arrests that lead to sudden death occur when the electrical impulses in the diseased heart become rapid (ventricular tachycardia) or chaotic (ventricular fibrillation) or both. This irregular heart rhythm (arrhythmia) causes the heart to suddenly stop beating.

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Transplantation of Kidneys from Black Cardiac-Death Donors Provide Black Recipients with the Best Long-Term Survival

Contrary to prevailing assumptions, Johns Hopkins researchers have shown that kidneys recovered from black donors who died from cardiac death offer the best survival rate for black recipients of a deceased-donor kidney.

This discovery, released online this week and appearing in the October 2008 issue of the Journal of the American Society of Nephrology, challenges the long-held belief that kidneys from white brain-death donors offers the best deceased-donor transplant survival rate for either black or white recipients.

“Our findings indicate that increased use of kidneys from cardiac-death donors could help reduce the organ shortage and improve outcomes for black kidney transplant recipients,” says lead author Jayme Locke, M.D., M.P.H., of the Department of Surgery at Johns Hopkins.

Locke and a team of Johns Hopkins researchers examined the outcomes of more than 25,000 black adults who received a deceased-donor kidney transplant between 1993 and 2006.

Results showed that black recipients who received a kidney from a black cardiac-death donor had a 70 percent reduction in the risk of kidney loss and a 59 percent reduction in risk for death when compared to black recipients who received a kidney from a white brain-death donor.

“Our data is consistent with the previous observation that black recipients seem to do better with kidneys from white brain-death donors than they do with kidneys from black brain-death donors or white cardiac-death donors, however, the fact that black recipients have the best outcomes with kidneys from black cardiac-death donors is significant,” says co-lead author Daniel Warren, Ph.D., of the Department of Surgery at Johns Hopkins.

He says that the exact mechanisms responsible for racial differences in outcomes after kidney transplantation are not known, however, the results suggest that the genetic background of the donor and recipient likely have a significant impact on long-term outcomes.

“We believe that an improved understanding of the molecular consequences of cardiac and brain death is critical to improving outcomes for all kidney transplant recipients and warrants further investigation,” he added.

There are currently more than 70,000 Americans waiting for kidney transplants. Only about 600 deceased-donor kidneys donated after cardiac death are currently used for transplantation versus 7,000 donated after brain death.

This discrepancy is due in part to the belief that kidneys that are exposed to cardiac death generally suffer more damage than kidneys that are exposed to brain death.

“Our results show this is not always true, and that is significant news for all patients waiting for a kidney,” says Locke.

Other researchers who worked on this study from Johns Hopkins include Robert Montgomery, M.D., Ph.D.; Andrew Cameron, M.D.; Joseph Melancon, M.D.; Dorry Segev, M.D.; Andrew Singer, M.D., Ph.D.; Christopher Simpkins, M.D., M.P.H.; Andrea Zachary, Ph.D.; Francesca Dominici, Ph.D.; Mary Leffell, Ph.D.; and Deborah McRann, B.S.N.