Chocolate Does a Man's Heart Good

By Steven Reinberg
HealthDay Reporter

MONDAY, Feb. 27 (HealthDay News) -- Chocolate lovers, take heart: Dutch research suggests that eating or drinking cocoa appears to lower blood pressure and even reduce the death risks for older men.

Since the 1700s, cocoa has been associated with healthy hearts, but only recently has scientific evidence backed up these claims, according to a new report in the Feb. 27 issue of the Archives of Internal Medicine.

According to the study, cocoa contains flavan-3-ols, which have been linked to lower blood pressure and improved function of the cells lining the blood vessels.

In their study, researchers led by Brian Buijsse, of the National Institute for Public Health and the Environment, in Bilthoven, examined links between cocoa and cardiovascular health in 470 men aged 65 to 84 years. The men had physical examinations and were interviewed about their diet at the start of the study in 1985 and then again in 1990 and 1995.

The researchers found that over a 15-year period, men who ate cocoa -- including chocolate -- regularly had significantly lower blood pressure compared with those who didn't.

The sweet treat might even help ward off death. The researchers reported that 314 men died over the course of the study, with 152 of those deaths blamed on heart disease. Men who consumed the highest amount of cocoa were half as likely to die from cardiovascular disease, compared to men who ate little or no cocoa, the team found. In addition, men who ate the most cocoa were less likely to die from any causes.

For these men, the risk remained low even after taking into account other factors, such as weight, smoking, physical activity, calorie intake and drinking alcohol, the researchers found.

The researchers believe that the lowered death risk didn't stem so much from lowered blood pressure, as from other heart-healthy benefits linked to flavan-3-ols. And since cocoa is rich in antioxidants, it may also protect against other diseases linked to oxidative stress, such as chronic obstructive pulmonary disease, and certain types of cancer, the researchers speculated.

One expert said the study helps confirm the use of cocoa as part of a healthful diet.

"Cocoa is the most concentrated source of bioflavonoid antioxidants readily available in our diets," said Dr. David L. Katz, an associate professor of public health, and director of the Prevention Research Center at Yale University School of Medicine.

"An accumulating body of evidence suggests that this translates into health benefits for those who consume cocoa or dark chocolate with a cocoa content of 60 percent or more. Benefits have been seen in endothelial function, a measure of blood vessel health, blood pressure, insulin levels, and serum lipids," added Katz, author of The Flavor Point Diet.

The evidence is now very consistent that cocoa has health-promoting effects, Katz said.

"However, it is almost certainly dose-dependent," he added, cautioning that there's a calorie-rich downside to excessive cocoa consumption. "Cocoa comes in foods that tend to be energy-dense, and the harm of excess calories could readily offset the benefit of antioxidants."

And he stressed that cocoa's heart-healthy benefits only come from bittersweet dark chocolate and in concentrated cocoa beverages, which contain an effective dose of antioxidants, along with magnesium, arginine and fiber.

"This is not the case for milk chocolate, which contains potentially harmful saturated fats, or candy bars that dilute cocoa with a long list of other ingredients," Katz said.

SOURCES: David L. Katz, M.D., M.P.H., associate professor, public health, director, Prevention Research Center at Yale University School of Medicine, New Haven, Conn., author The Flavor Point Diet; Feb. 27, 2006, Archives of Internal Medicine

Copyright © 2006 ScoutNews LLC. All rights reserved.

Vitamin D Protects Against Tuberculosis

By Ed Edelson
HealthDay Reporter

THURSDAY, Feb. 23 (HealthDay News) -- Discovery of the molecular mechanism that the body uses to fight off tuberculosis could open the way to use of ordinary vitamin supplements to help prevent the disease, researchers report.

The finding also helps explain why blacks are more vulnerable than whites to tuberculosis and why they develop more severe cases when infected, according to a study in the Feb. 23 online issue of Science.

The story starts about a decade ago, when research revealed that the immune system of fruit flies produces a protein that attacks bacteria and fungi, explained study author Dr. Robert L. Modlin, chief of dermatology at the University of California, Los Angeles.

"In 1999, it became clear that there were equivalents in humans, a family of proteins," Modlin said. "Each recognizes a defined biochemical from a bacterium or virus."

Studies showed that in mice, the defense involved production of nitric oxide to fight infection. However, that was not found to happen in human cells, Modlin said.

Four years of work led to the finding that the human defense mechanism involves vitamin D, he said. White blood cells are stimulated to convert ordinary vitamin D -- which is produced, in large part, by exposure to sunlight -- into an active form that is used to make a protein that kills the tuberculosis bacteria.

"Our other main finding was that African-Americans, who are known to be more susceptible to tuberculosis, have lower levels of vitamin D in their blood," Modlin said. Melanin, the pigment that darkens skin, absorbs the ultraviolet rays of sunlight, reducing vitamin D production in blacks, he explained.

Cells grown in blood serum from black individuals produced 63 percent less of the bacteria-fighting protein than those grown in blood serum from white people. Adding vitamin D to the cultures increased production of the protein, Modlin said.

One question raised by the discovery is whether giving vitamin D to humans can do the same thing, he said, adding, "Were hoping this paper will raise interest in that."

If the vitamin does have a protective effect, "a vitamin D supplement I think is the way to go," Modlin said. As a dermatologist, he noted, he is acutely aware of the damage that can be done by overexposure to sunlight.

However, "I can't recommend that people take vitamin D supplements yet," Modlin said. "We need to do more studies." His group is doing studies along that line, looking at "what effects vitamin D might have on the immune system."

There's a possibility that the work might have implications beyond tuberculosis, Modlin said. "Our results indicate we have much yet to learn about human immune responses to infections," he said.

SOURCES: Robert L. Modlin, chief, dermatology, University of Califonia, Los Angeles; Feb. 23, 2006, Science Express

Copyright © 2006 ScoutNews LLC. All rights reserved.

U.S. Health-Care Costs to Go Up - Way Up

By Amanda Gardner
HealthDay Reporter, HealthDay News

Predictions that health-care costs in the United States will rise dramatically as the population continues to age appear to be coming true.

According to federal forecasters, by 2015 one in every five U.S. dollars will be spent on health care, for total annual health-care spending of more than $4 trillion.

The forecasters also predict that growth in health spending will surpass growth in the United States' gross domestic product (GDP) over the next decade. Health spending will make up 20 percent of GDP, vs. 16 percent today.

"There is a continuous, steady climb from 2005," said John Poisal, deputy director of the National Health Statistics Group at the Centers for Medicare and Medicaid Services and co-author of the projections, which appear in the Feb. 22 online exclusive issue of Health Affairs.

According to the forecasters, America's health-care future looks something like this:

* Growth in national health spending is expected to decline to 7.3 percent in 2005, down from a high of 9.1 percent in 2002. Growth in national health spending will average 7.2 percent over the next 10 years, or 2.1 percentage points faster than GDP growth but slower than in the recent past.
* Growth in private health insurance premiums are projected to slow to 6.6 percent in 2005, with the pace picking up again in 2007.
* Hospital spending growth is projected to be 7.9 percent in 2005, and by 2015 is expected to reach $1.2 trillion, or double what it is today. Much of this is fueled by a boom in urban hospital building.
* Similarly, spending on prescription drugs is expected to reach $446 billion in 2015, up from $188 billion in 2004. Over the decade, average annual spending growth for prescription drugs is projected to be 8.2 percent, two percentage points below last year's projection. Total prescription drug spending is expected to grow 7.7 percent in 2006.
* Medicare spending will reach $792 billion in 2015, up from $309 billion in 2004. Growth will reach 25.2 percent in 2006, largely as a result of the implementation of the Medicare Part D drug benefit. Spending growth will slow to 5.4 percent in 2007, but will average 7.5 percent from 2008 to 2015.
* Medicaid spending will reach $320 billion in 2006, up from $293 billion in 2004. Growth is expected to rise to 8.5 percent in 2007, and average 8.6 percent a year until 2015, at which point spending is anticipated to be $670 billion.
* Growth in state, local and federal government spending on public health is estimated at 10.5 percent in 2005, more than double the rate of the year before, largely due to devastation wrought by hurricanes Katrina and Rita. Federal public health spending is forecast to increase 24.3 percent in 2005, more than four times the rate of 2004, for a total of $11.3 billion.
* Growth in private health insurance premiums will continue to decline, down from 8.4 percent in 2004 to 6.8 percent in 2005.
* Out-of-pocket spending growth will likely remain stable at 5.6 percent in 2005 while out-of-pocket payments are expected to decline 1 percent in 2006. All in all, consumers will spend $421 billion of their own money on health care by 2015, up from $248.8 billion in 2005.
* Nursing home spending is expected to grow by 5.6 percent in 2005, up from 4.3 percent in 2004, largely the effect of an aging population.
* Home health spending is projected to grow 13.2 percent in 2005, to reach nearly $49 billion. It represents the fastest-growing health-care sector.

SOURCES: Feb. 21, 2006, news conference with John Poisal, deputy director, National Health Statistics Group, Centers for Medicare and Medicaid Services; March 2006 Health Affairs

Health Tip: Paxil and Pregnancy Don't Mix

(HealthDay News) -- Researchers have found that taking Paxil, a popular antidepressant, in the first three months of pregnancy can increase the risk of birth defects, the U.S. Food and Drug Administration said in a December 2005 news release.

"FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus," the agency said.

The FDA recommends that expectant mothers who are taking -- or considering taking -- Paxil and similar antidepressants discuss with their doctors the potential risks and benefits.

-- Deborah DiSesa Hirsch

FDA Informs Public Of Nationwide Infant Formula Recall

The U.S. Food and Drug Administration (FDA) is alerting the public to a recall being conducted by Mead Johnson for their GENTLEASE powdered infant formula, lot number: BMJ19, use by 1 Jul 07. This lot was found to contain metal particles, consisting of up to 2.7 millimeter in size.

No illnesses have been reported to date. However, in the rare instance that an infant were to inhale the infant formula into the lungs, the presence of these particles could present a serious risk to the infant's respiratory system and throat. Any injuries associated with this problem would be likely to show up within three to four hours. The symptoms could be varied depending on whether there is damage to the throat or lungs. Damage to the throat may include coughing, difficulty swallowing or difficulty breathing. Similarly damage to the lungs could include coughing and difficulty breathing. If you may have fed this lot of GENTLEASE to your baby, and you have any concerns about your baby's health, you should contact your baby's health professional for guidance.

There were approximately 41,464 24-ounce cans of this lot of recalled product distributed, beginning on December 16, 2005, through many major retail stores across the country, so the consumer should concentrate on the code on the can rather than on the place of purchase. The affected products can be identified by the lot number and expiration/use by date embossed on the bottom of the can of BMJ19, use by 1 Jul 07.

Mead Johnson informed the FDA of this problem. FDA and Mead Johnson are currently investigating the cause of the metal particles found in the infant formula in this highly unusual incident.

Consumers who have a can of this batch of GENTLEASE powdered infant formula should not use the product and should contact Mead Johnson at 888-587-7275 immediately.

http://www.fda.gov

Antifungal Treatment Wins FDA Approval

(HealthDay News) -- A drug designed to treat yeast-like fungal infections that often strike hospital patients and people with compromised immune systems has been approved by the U.S. Food and Drug Administration.

Pfizer's Eraxis (anidulafungin) treats infections caused by Candida fungus, which often affects the bloodstream, esophagus, and abdominal cavity, the FDA said. Candidemia, a bloodstream infection caused by the fungus, is among the most deadly hospital-acquired infections of its type, with a fatality rate of about 40 percent, Pfizer said in a statement.

Candidemia affects about 1 in 5,000 people in the United States -- an estimated 60,000 cases each year. The infection causes patients to spend an average of about 10 additional days in the hospital, at a cost of about $39,000 per patient, Pfizer said.

The most common adverse side effects seen during clinical testing of the new drug included diarrhea, mild elevations in certain liver enzymes, headache, and mild allergic reactions, the FDA said.

-- Scott Roberts

Health Tip: Drugs to Avoid While Breast-Feeding

(HealthDay News) -- If you're breast-feeding, you should stay away from certain drugs, according to the U.S. Department of Health and Human Services.

These include medications for anxiety, depression, migraines and chemotherapy, the agency says.

Medications whose effects on nursing infants may be cause for concern include:

* Anti-anxiety drugs: Alprazolam, Diazepam, Lorazepam, Midazolam, Perphenazine, Prazepam, Quazepam, Temazepam.
* Antidepressant drugs: Amitriptyline, Amoxapine, Bupropion, Clomipramine, Desipramine, Dothiepin, Doxepin, Fluoxetine, Fluvoxamine, Imipramine, Nortriptyline, Paroxetine, Sertraline, Trazodone.
* Antipsychotic drugs: Chlorpromazine Galactorrhea, Chlorprothixene, Clozapine, Haloperidol, Mesoridazine, Trifluoperazine.
* Other drugs: Amiodarone, Chloramphenicol, Clofazimine, Lamotrigine, Metoclopramide, Metronidazole, Tinidazole.

Talk to your doctor if you're not sure about whether any medication you're taking could harm your breast-feeding infant.

-- Deborah DiSesa Hirsch

New York Times Examines Concerns Over High Cost Of Cancer Medication Avastin

The New York Times on Wednesday examined how doctors are warning that the potential $100,000 annual price for use of Genentech's colon cancer medication Avastin as a treatment for breast or lung cancer could discourage patients from seeking the treatment. According to the Times, studies show that Avastin -- which is FDA-approved for the treatment of colon cancer -- prolongs late-stage breast or lung cancer patients' lives by several months if combined at a higher dose with existing drugs. Some doctors currently prescribe Avastin for off-label use to treat breast or lung cancer, and Genentech later this year plans to seek FDA approval for such uses, the Times reports. The company has announced that it plans to charge approximately $100,000 annually for Avastin as a treatment for breast or lung cancer, nearly double the drug's current cost as a colon cancer treatment. According to the Times, pharmaceutical companies commonly attribute high drug prices to research and development costs. However, executives at Genentech and Roche, the company's majority shareholder, attribute Avastin's price to its value as a life-sustaining therapy, the Times reports. The higher price for Avastin as a treatment for breast or lung cancer can be partly attributed to using a higher dose of the drug to treat those conditions, the Times reports.

Health Insurance Issues
Some doctors say the proposed price is discouraging patients from taking Avastin as a breast or lung cancer treatment, and health insurers often do not cover treatments for uses that do not have FDA approval, the Times reports. "Insurers may say, 'It's not approved for that indication, so we're not paying for it,'" Paul Bunn, director of the University of Colorado Cancer Center, said. Patients who want to take Avastin for breast or lung cancer treatment have to sign a waiver promising to reimburse the hospital for the cost if their health insurers decline coverage, according to the Times. "A couple of patients have refused to sign or take treatment," Bunn said. Some doctors also say Genentech's $8,800 per month pricing plan for Avastin could encourage other pharmaceutical companies to raise prices for their cancer treatments, the Times reports. Susan Desmond-Hellmann, president of product development at Genentech, said, "I don't think any patient should go without a Genentech drug for an inability to pay" (Berenson, New York Times, 2/15).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Rheumatoid Arthritis Drug Could Fight Problem Asthma

By Serena Gordon
HealthDay Reporter

THURSDAY, Feb. 16 (HealthDay News) -- Using a well-known rheumatoid arthritis drug to reduce high levels of an inflammatory protein could be a new means of fighting severe asthma , British researchers report.

Their study found that people with severe asthma have higher-than-normal concentrations of an inflammation-linked cytokine called tumor necrosis factor alpha (TNFa). Reducing the levels using a TNF-inhibiting drug, etanercept, reduced asthma symptoms in people with refractory -- hard to manage -- disease.

"Open-label use of etanercept for three months in patients with refractory asthma improved airflow measures and symptoms scores, and reduced bronchial hyperresponsiveness," wrote Dr. Serpil Erzurum, from the Cleveland Clinic, in an editorial accompanying the study in the Feb. 16 issue of the New England Journal of Medicine.

However, Erzurum also cautioned against widespread use of TNF inhibitors in the treatment of asthma until more studies are done, because these medications can have serious side effects. Potential side effects include a boost in risk for serious infections such as pneumonia, as well as an increased cancer risk.

Asthma, which affects about 20 million Americans, is a chronic disease of the airways that can cause wheezing, difficulty breathing and shortness of breath, according to the National Heart, Lung, and Blood Institute. Numerous medications are available to treat the disorder, and with proper treatment most people can keep it under control.

However, according to Erzurum, in about 10 percent of the cases, asthma becomes very hard to control, severely impacting on quality of life. Many patients must make chronic use of oral steroids, which can have significant side effects. These hard-to-manage cases account for about half of the health-care costs linked to asthma. They also represent a large portion of asthma complications and deaths.

Etanercept, sold under the brand name Enbrel, is a TNF-inhibitor drug already prescribed for autoimmune diseases such as rheumatoid arthritis or ankylosing spondylitis.

The first phase of the current study compared 10 people who didn't have asthma to 10 people with mild-to-moderate asthma and another 10 people with tough-to-treat disease. British researchers from the National Health Service looked for differences in the levels of TNFa between these three groups.

They found that people with severe asthma had about twice the TNFa activity as people without asthma. Severe asthmatics also had higher levels than people with mild-to-moderate asthma.

Dr. Jonathan Field, director of the allergy and asthma clinic at New York University Medical Center/Bellevue in New York City, said he wasn't surprised by the findings.

"TNF is one of the many inflammatory cytokines linked to allergy and autoimmune diseases. This is one of the times it has been well-documented, however," he said.

To further examine the role of TNF in refractory asthma, the researchers tested the known TNF inhibitor, etanercept, on participants with hard-to-control disease. Half began the study taking etanercept twice a week for 10 weeks, while the other half received a placebo. After a one-month rest, the groups were switched and those that had received the placebo were now given the drug and vice-versa. During the study, neither the researchers nor the patients knew who was receiving the medication.

Asthma severity, measured by lung function tests, was significantly reduced for those taking the medication, the study found. On a quality-of-life scale of seven points, scores improved by an average of nearly one point when people were taking etanercept compared to the placebo.

The authors point out that their findings are only applicable to those with severe asthma, and not for those with mild-to-moderate asthma. That's because these milder cases don't have the high levels of TNF seen in people with severe asthma.

"For people with severe, refractory asthma, this may be a hopeful adjunct therapy, but we have to be very aware of the potential side effects," said Field.

Field added that more studies need to be done on much larger groups of people before this could possibly become a standard treatment.

Dr. Malourdes de Asis, chief of allergy at Nyack Hospital in New York, echoed Field's sentiments.

"This is a promising therapy for people with refractory asthma, but it's expensive and we still need more studies and a multi-center trial," she said.

SOURCES: Malourdes de Asis, M.D., chief, allergy, Nyack Hospital, Nyack, N.Y.; Jonathan Field, M.D., director, allergy and asthma clinic, New York University Medical Center/Bellevue, New York City; Feb. 16, 2006, New England Journal of Medicine

Lower Priced Drugs Act Of 2006 Would Help Speed Affordable Medicines To Market - Consumers Benefit From Stabenow-Lott Bill, Says GphA, USA

The Generic Pharmaceutical Association (GPhA) today said American consumers would benefit from the "Lower Priced Drugs Act of 2006," because the legislation would remove onerous hurdles that slow affordable generics from coming to market. The bill was introduced today by Senators Debbie Stabenow (D-MI) and Trent Lott (R-MS).

"Despite continued efforts to close unintended loopholes that delay generic competition, unnecessary barriers to market entry remain. These loopholes delay the timely introduction of affordable medicines, forcing consumers, insurers, and the government to pay brand prices for years to come," said GPhA President and CEO Kathleen Jaeger.

"By closing some of these unintended loopholes, the Lower Priced Drugs Act will improve consumers' timely access to affordable medicines. We commend Senators Stabenow and Lott for their efforts," said Jaeger.

The Lower Priced Drugs Act includes important provisions to facilitate greater access to generic antibiotics, combat frivolous patent abuse by brand companies, and bring meaningful reform to the pediatric exclusivity period.

Ensuring that generics reach the market in a timely manner could result in significant cost savings for consumers, given that generics cost 30% to 80% less than brands. For every one percent increase in generic utilization, consumers could save $4 billion annually.

In addition to providing consumers with health care savings, Jaeger pointed out that generic drugs are an essential cost containment tool for public health programs such as Medicaid and Medicare. Earlier this month, the Centers for Medicare and Medicaid Services acknowledged that costs for the Medicare prescription drug benefit will be $8 billion less than expected, in part because of the lower cost of generic medicines.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 53% of the total prescriptions dispensed in the United States, but less than 12% of all dollars spent on prescription drugs.

For more information about the industry, visit http://www.gphaonline.org

FDA Issues New Guidance on Whole Grains

By LIBBY QUAID, AP Food and Farm Writer

The Food and Drug Administration issued new guidelines Wednesday to help people figure out which bread or cereal meets the government's recommendations for eating heart-healthy whole grains.

Pizza or bagels labeled as "whole grain" or "whole wheat" should have dough made entirely from whole wheat or whole grain flour, FDA said. "Whole grains" are cereal grains including corn, rice, oats and wheat, and they must be intact, ground, cracked or flaked, according to FDA.

Consumers need a consistent definition for whole grains, said Barbara Schneeman, director of the FDA's office of nutritional products, labeling and dietary supplements.

"Using the term multigrain or seven-grain doesn't necessarily mean that product contains whole grains," she said.

Government dietary guidelines say three servings of whole grains daily will reduce the risk of heart disease and type 2 diabetes. A serving is about an ounce — a half-cup of oatmeal, a slice of bread, a cup of cold cereal flakes.

It's the first time FDA has tried to define whole grains, although the new definition raises questions as well as answers. FDA recently turned down a request from General Mills, maker of Wheaties and other well-known cereals, to say what constitutes an "excellent source" or a "good source" of whole grains.

Both claims are common on packages throughout supermarkets, and FDA was unclear about whether it wants them removed. "We would have to look at a particular product to understand whether something is being used appropriately," Schneeman said.

Medications and imaginations help reduce post-operative pain in children, new study says

A new study by a nurse researcher shows that imagery – a simple method of distraction – can be used with pain medications to significantly reduce post-operative pain in children.

In the study, which was led by a nurse researcher at Cincinnati Children's Hospital Medical Center, children who had their tonsils or adenoids removed were given an audio tape that enabled them to imagine they were going to "a favorite place." The children who used the tape reported significantly lower pain in the 24 hours after surgery than those who didn't use the tape.

"When treating pain in children, we should appeal not only to the senses but also to feelings and emotions," says Myra Huth, PhD, RN, assistant vice president of nursing research at Cincinnati Children's and the study's main author. "Pain medications should be used in conjunction with comfort techniques. However, we still have work to do in this area."

The NIH-funded study, published in the current issue (July) of the journal Pain, examined the effectiveness of imagery and pain medications in reducing pain and anxiety after surgery for tonsillectomy and at home. Dr. Huth recruited 73 children between the ages of 7 and 12. Approximately half watched a video tape on the use of imagery and listened to a 30 minute audio tape of imagery a week prior to surgery. One to four hours after surgery, they listened to the audio tape and then listened to the tape at home approximately 24 hours after surgery.

Those who used imagery reported significantly less pain after ambulatory surgery but not at home, perhaps because their anxiety had decreased by being at home. "Some children used the tape to help them sleep before their surgery," says Dr. Huth. "I think it helped relieve anxiety before surgery and on the day of surgery, but once they got back into a safe environment, it wasn't as effective."

Dr. Huth examined pain only from the removal of tonsils or adenoids, but she believes imagery would be effective in reducing anxiety during children's hospital stays and in distracting them during most intrusive procedures. Her study indicated that even when given less than the recommended amounts of pain medication, children who used imagery reported reduced pain. But she is a staunch proponent of both approaches.

"The need for interventions that reduce children's acute pain on a short-term basis is growing as a result of the continued demand for outpatient surgery, shortened hospital stays and difficulties with pain management in both the ambulatory setting and at home," she says. "We need to get better in adequately dosing pain medications in conjunction with using distraction techniques," she says. "Nurses are beginning to think differently about how they practice and how they can help patients and families with non-traditional methods of pain management."

Cincinnati Children's Hospital Medical Center is a 423-bed institution devoted to bringing the world the joy of healthier kids. Cincinnati Children's is dedicated to transforming the way health care is delivered by providing care that is timely, efficient, effective, patient-centered, equitable and safe. It ranks third nationally among all pediatric centers in research grants from the National Institutes of Health. The Cincinnati Children's vision is to be the leader in improving child health. Additional information can be found at http://www.cincinnatichildrens.org.

Contact: Jim Feuer
jim.feuer@cchmc.org
513-636-4656
Cincinnati Children's Hospital Medical Center

Levitra has mental health benefits, study suggests

The impotence drug Levitra (also known as vardenafil) improves erectile function and depression in men with both disorders, research shows.

Although depression is common among men with erectile dysfunction (ED), previous studies have not investigated the potential mental health benefits of Levitra in men with ED, investigators point out in the American Journal of Psychiatry.

Dr. Raymond Rosen from UMDNJ-Robert Wood Johnson Medical School, Piscataway, New Jersey and colleagues evaluated the efficacy of Levitra in the treatment of 280 men with ED and untreated depression. The men were assigned to Levitra or placebo for 12 weeks.

All erectile function parameters improved significantly with Levitra treatment, the authors report. Levitra treatment was associated with significant improvements in intercourse satisfaction, orgasmic function, overall satisfaction, and sexual desire.

Moreover, depression scores improved significantly during Levitra therapy, the researchers note, and significantly more patients treated with the drug (58 percent) experienced a remission of depressive symptoms than did patients treated with placebo (32 percent).

This study, the authors conclude, suggests that Levitra treatment can improve depressive symptoms in men with ED and depression, regardless of whether ED is causally related to their depression.

"This reinforces the concept that treatment of physical symptoms in depression can enhance treatment outcomes and overall quality of life and reduce the risk of relapse," they add.

SOURCE: American Journal of Psychiatry January 2006.

FDA: Merck Had Time to Warn About Vioxx

By JANET McCONNAUGHEY, Associated Press Writer

Merck & Co. could have warned that its popular painkiller Vioxx might increase the risk of heart attacks as soon as the first evidence showed up, rather than waiting two years for federal approval, a former Food and Drug Administration official testified Friday.

Richard Kapit said there was plenty of time to alert the public before Richard "Dickie" Irvin began taking Vioxx, which his widow claims caused his fatal heart attack after a month on the drug in 2001.

Merck says it alerted the FDA in 2000 that a study showed heart attacks occurred five times as often in patients taking Vioxx as those on another drug, called naproxen. The agency didn't approve the label change until April 2002.

The company pulled the drug from the market in September 2004, after another study showed that it could double the risk of heart attacks.

Kapit, who worked for the FDA for 16 years, mostly as a drug application reviewer analyzing adverse effects, said companies are allowed to change a drug label as soon as it applies for permission to add or strengthen a warning, precaution, or other information about a serious side effect.

"The FDA is a bureaucracy ... you don't want to wait until it goes through all the records," he said.

He said he saw hundreds of such applications during his years at the FDA, which he left in 2002. He did not work on Merck's application for Vioxx.

Under cross-examination, he said he based his analysis on about 80 pages of documents supplied by the plaintiff and his knowledge of FDA regulations.

The New England Journal of Medicine's Executive Editor, Dr. Gregory Curfman, also testified in a videotaped deposition played for the jury Friday, saying the information about the drug's effects should have been added to an article about the drug before it was published.

Merck contends it learned the information about heart attacks, which occurred after a reporting deadline set in the study. Curfman said scientific journals expect important updates.

More of Curfman's deposition will be played when the trial resumes Monday. Testimony is expected to last most of the week, with closing arguments expected Friday.

The initial case ended in a mistrial last year.

Rx Companies Developing Plan To Provide Discounted Drugs To Fill 'Doughnut Hole' In Medicare Drug Benefit

A group of seven pharmaceutical companies is working on a plan that would provide discounted prescription drugs to Medicare beneficiaries whose annual drug costs fall into the so-called "doughnut hole," or the gap in coverage under the new Medicare drug benefit, the Wall Street Journal reports. Under the drug benefit, Medicare beneficiaries are responsible for all drug costs between $2,250 and $5,100 in total spending, or between $750 and $3,600 in out-of-pocket costs. An estimated 6.9 million Medicare beneficiaries are expected to reach the doughnut hole in 2006, according to the Kaiser Family Foundation, the Journal reports. According to documents filed on Jan. 12 with the HHS Office of Inspector General, the pharmaceutical companies are joining together to provide discounts of at least 50% on their drugs when qualifying Medicare beneficiaries reach the doughnut hole. The Bridge Rx program, which the companies hope to announce in April and launch in May, would have copayments of at least 15%, the Journal reports. Medicare beneficiaries with annual incomes between $14,000 and $18,620 would qualify for the program, as would beneficiaries who have annual incomes lower than $14,000 and assets that make them ineligible for additional financial help under the drug benefit. The projected budget for the program's first year is $30 million, with projected enrollment in 2006 of more than 500,000 Medicare beneficiaries. Companies that plan to participate in the program include AstraZeneca, Johnson & Johnson, Novartis and Bristol-Myers Squibb.

Concerns
According to the Journal, the federal government has said the program could "run afoul of anti-kickback laws unless properly structured." According to the Journal, the small number of participating companies so far "is a potential problem, because the government worries that companies could use the discounts to steer patients to their drugs." The HHS OIG on Jan. 16 in an informal response to the companies' proposal, which the companies sent to HHS on Jan. 12, raised several issues, including the need to provide uniform discounts for all drugs and safeguards to ensure participants do not switch from less-expensive generic drugs to brand-name medications. In an advisory bulletin issued last fall before the plan was presented, the federal government said the "risk" of a kickback "potentially may be reduced" if large numbers of companies participated in such a program and included all of their drugs. CMS Administrator Mark McClellan said the government has been in discussions about the creation of a doughnut hole program, adding that the HHS OIG has said such a plan would work as long as it includes "a broad range of drugs." The HHS OIG is expected to issue a formal opinion on the program by mid-February.

Comments
"It's uncharted waters, so we don't know what" the HHS OIG's office will decide, an unnamed person familiar with the plan said, adding that it is a "good sign" federal officials are in discussions about such a program. The Bridge Rx coalition is working to persuade other large companies, including generic drug makers, to join the group. Pfizer, GlaxoSmithKline and Merck are some of the drug companies that have not yet joined the program. A spokesperson for GSK said the company "is looking at a number of options in terms of ways in which we might be able to help seniors." A spokesperson for Merck said, "[W]e'd certainly see what comes out of" Bridge Rx's efforts and "always examine our options." A Pfizer spokesperson said the company is reviewing the Bridge Rx plan (Martinez, Wall Street Journal, 2/7).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

FDA Approves CLARINEX-D(R) 12 HOUR (desloratadine 2.5mg/pseudoephedrine 120mg) Tablet Prescription Antihistamine With Decongestant

Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved CLARINEX-D® 12 HOUR (desloratadine 2.5 mg and pseudoephedrine sulfate, USP 120 mg) Extended Release Tablets for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older.

CLARINEX-D 12 HOUR will be available nationwide in March 2006, in time for the spring allergy season. The new treatment option addresses an important need for allergy sufferers, who indicate that nasal congestion is the most bothersome symptom of allergic rhinitis.(1) In addition, a survey of 1,000 adults with allergic rhinitis found nearly 85 percent experience nasal congestion when they first wake up, making it the most prevalent allergy symptom in the morning.(2)

"For my patients who report nasal congestion along with other allergy symptoms, an antihistamine and decongestant combination treatment provides safe and effective relief," said William Lumry, M.D., Allergy & Asthma Specialists, Dallas, Texas. "With CLARINEX-D 12 or 24 hour extended release tablets, I can now prescribe a 12- or 24-hour formulation that does not cause drowsiness and treats their nasal blockage effectively."

The new formulation uses a bi-layer tablet delivery system, which controls the release of the pseudoephedrine component for consistent delivery. The recommended twice-daily dosing of CLARINEX-D 12 HOUR will help patients control their nasal congestion, along with their sneezing, runny nose, itchy throat, or itchy and watery eyes, in the morning and throughout the day.

"Physicians now have a 12-hour formulation that combines the proven efficacy and safety of CLARINEX with an established decongestant," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough. "CLARINEX-D 12 HOUR provides physicians with another option for tailoring allergy treatment regimens based on patients' specific symptoms and needs."

The FDA approved CLARINEX-D 12 HOUR based on results from two clinical trials involving 1,248 patients 12 to 78 years of age with seasonal allergic rhinitis, 414 of whom received CLARINEX-D 12 HOUR. In both 2-week randomized, parallel group trials, the antihistaminic efficacy of CLARINEX-D 12 HOUR, when examining symptoms of allergic rhinitis excluding nasal congestion, was significantly greater than that of pseudoephedrine alone during the treatment period. And the decongestant efficacy of CLARINEX-D 12 HOUR was significantly greater than that of desloratadine alone during the treatment period, based on nasal congestion scores. As the data show, CLARINEX-D 12 HOUR effectively treats nasal congestion, the most bothersome symptom of allergic rhinitis, in addition to relieving other nasal and non-nasal symptoms of allergic rhinitis.

The most commonly reported adverse events for CLARINEX-D 12 HOUR Extended Release Tablets compared with desloratadine alone are insomnia (10% vs. 3%), headache (8% vs. 8%), dry mouth (8% vs. 2%), fatigue (4% vs. 2%), somnolence (3% vs. 4%), pharyngitis (3% vs. 3%) and dizziness (3% vs. 2%).

CLARINEX-D 12 HOUR Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired.

About Allergies

Seasonal allergies affect an estimated 36 million people in the U.S. Symptoms, which include sneezing, runny nose, congestion, itchy throat, or itchy and watery eyes, can have a significant impact on everyday activities at work, school and leisure time.(3) There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.(4)

About the CLARINEX Family of Products

CLARINEX is the only branded prescription allergy treatment available in this diverse variety of formulations. CLARINEX® (desloratadine) 5 mg Tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 12 years of age and older. CLARINEX RediTabs® (desloratadine) 2.5 orally-disintegrating tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 6 years of age and older; a 5mg RediTabs tablet is available for patients 12 years and older. CLARINEX Syrup (desloratadine) 0.5 mg per 1 mL, available in a bubblegum flavor, is approved for the relief of symptoms of outdoor allergies in children 2 years and older, and indoor allergies and hives of unknown cause in children as young as 6 months. (5) CLARINEX-D® 24 HOUR (desloratadine 5 mg/pseudoephedrine USP 240 mg) Extended Release Tablets is a once-daily prescription antihistamine and decongestant combination treatment which provides 24-hour relief of nasal and non-nasal symptoms of outdoor allergies in patients 12 years of age and older.(6)

CLARINEX Tablet side effects in patients 12 years of age and older with seasonal and year-round allergies were similar to placebo and included sore throat, dry mouth and fatigue. Tablet side effects in patients 12 years of age and older with ongoing itching and rash from hives of unknown cause were headache, nausea and fatigue. Syrup side effects in children 6 to 11 years of age were similar to placebo. For children 6 months to 5 years of age, syrup side effects varied by age and included fever, diarrhea, upper respiratory infection, irritability and coughing.(5)

Due to its pseudoephedrine component, CLARINEX-D 12 Hour Extended Release Tablets should not be taken by patients with narrow-angle glaucoma (abnormally high eye pressure), difficulty urinating, severe high blood pressure, or severe heart disease, or by patients who have taken a monoamine oxidase (MAO) inhibitor within the past fourteen (14) days. Patients with high blood pressure; diabetes; heart disease; increased intraocular pressure (eye pressure); thyroid, liver or kidney problems; or enlarged prostate should check with their healthcare provider before taking CLARINEX-D 12 HOUR. Care should be used if CLARINEX-D 12 HOUR is taken with other antihistamines or decongestants because combined effects on the cardiovascular system may be harmful. The most commonly reported adverse events for CLARINEX-D 12 HOUR Extended Release Tablets were, insomnia, headache, dry mouth, fatigue, drowsiness, sore throat, and dizziness.(7)

Visit www.CLARINEX.com for more information on preventing and treating seasonal nasal allergies. For additional important safety information, full prescribing information is available at: www.spfiles.com/piclarinex.pdf.

SSCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements related to CLARINEX and the potential market for CLARINEX. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statements. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details about these or other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's third quarter 2005 10-Q.

References:
1. Roper Public Affairs and Media. Impact of nasal congestion among allergic rhinitis sufferers, 2004.
2. Roper Public Affairs and Media. Assessment of morning allergy suffering among adults with allergies, 2005.
3. The American Academy of Allergy, Asthma & Immunology, Inc., The Allergy Report, 2000.
4. Linneberg A, Henrik Nielsen N, Frolund L, et al. The link between allergic rhinitis and allergic asthma: a prospective population-based study. The Copenhagen Allergy Study,. Allergy 2002; 57: 1048-52.
5. CLARINEX(R) Tablets, Syrup and RediTabs Product Information. Schering Corporation.
6. CLARINEX-D(R) 24 HOUR Product Information. Schering Corporation.
7. CLARINEX-D(R) 12 HOUR Product Information. Schering Corporation.

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., USA.

Schering-Plough Corporation
http://www.schering-plough.com

Health Tip: Women Have Different Heart Attack Symptoms

(HealthDay News) -- Almost 50 percent of women who die of a heart attack have no clinical symptoms, according to a U.S. National Institutes of Health study.

Women heart attack victims often are not treated as aggressively as men with the same symptoms and more often die, the agency says.

Some women experience nausea, a cold sweat, or light-headedness when having a heart attack.

Doctors strongly advise that even if you're not sure if it's a heart attack, get checked out immediately.

-- Deborah DiSesa Hirsch

A genome wide search for genes underlying anxiety disorders turned up unexpected candidates

Increasing the activity of two enzymes better known for their role in oxidative stress metabolism turns normally relaxed mice into "Nervous Nellies," according to research conducted at the Salk Institute for Biological Studies and reported in the early online edition of Nature.

Locally overexpressing either glyoxalase 1 or glutathione reductase 1 in mouse brains significantly increased anxiety in usually relaxed mice and made already jittery mice even more anxiety-ridden. Inhibition of glyoxalase 1 had the opposite effect.

"Currently, very little is known about the genes that predispose to psychiatric disease," says first author Iiris Hovatta, who was a postdoctoral research in Salk's Laboratory of Genetics when the research was conducted. "All of the 17 genes that we identified are very good candidates for human anxiety disorders and most of them have never been associated with anxiety-related behavior before," she adds.

"This is a very exciting study where we can genetically interfere with the behavior outcome, emphasizing the genetic hard wiring of certain traits,'' says Inder Verma, professor in the Laboratory for Genetics at the Salk Institute.

Out of the 17 candidates, the researchers focused on the most promising ones, glyoxalase 1 and glutathione reductase 1, since both enzymes belonged to the same metabolic pathway. In addition, a study by Turkish scientists had found elevated levels of oxidative stress markers in patients with severe anxiety disorders. "It might be that oxidative stress metabolism and anxiety levels are linked, although we do not know the exact mechanism at the moment," says Hovatta.

Like other complex psychiatric traits, fear and anxiety are influenced by many genes. There is no such thing as a single "fear" gene that lets anxiety spiral out of control when the gene's regulation is disturbed, making it difficult to identify the genetic roots of anxiety disorders.

For their study, the scientists relied on inbred mouse strains that differ considerably in their natural anxiety levels. Just like in humans suffering from anxiety disorders, the sights and sounds of unfamiliar environments can trigger panic in mice with anxious dispositions, causing them to freeze in place. Unlike their more relaxed contemporaries, naturally nervous mice are not explorers and may seem wary of open spaces.

Instead of studying individual genes the researchers simultaneously assessed the activity patterns of about 10,000 genes in specific brain regions with the help of microarrays. This extensive scan allowed the researchers to pinpoint multiple genes whose expression levels differed in relaxed and anxiety-prone mice.

To increase the specificity of their microarray analysis, they looked in only specific brain areas that have been shown to play a role in anxiety and fear (the amygdala, bed nucleus of the stria terminalis, cingulate cortex, hippocampus, hypothalamus, central peri-aqueductal grey and pituitary gland).

"We were incredibly surprised since out of the entire genome only 17 genes were robustly correlated with anxiety levels across many different strains," says Carrolee Barlow, lead author of the study and an adjunct professor in the Laboratory of Genetics. "Almost half of them were enzymes and not neurotransmitters as one might expect."

In the past, scientists tried to correlate complex psychiatric diseases with different forms of the genes controlling neurotransmitters, the chemical messengers that brain cells use to shuttle outgoing signals to neighboring cells, and their receptors, albeit with limited success. "That's why we chose an unbiased approach that didn't limit us to neurotransmitters," explains Barlow.

Now, Hovatta wants to find out what relevance, if any, the identified genes have to human anxiety disorders. "It is really exciting to study neurobiology of anxiety in mice and to understand the molecular mechanisms behind the regulation of behavior, but I am mostly interested in trying to find genes that predispose humans to anxiety disorders and to perhaps in the future try to develop better treatment practices. We are still far away from that," she cautions, "but it is the long term goal of the project."

Researchers contributing to the study include first author Iiris Hovatta, formerly at the Salk Institute, now at National Public Health Institute in Helsinki Finland, research assistants Richard S. Tennant and Robert Helton, research fellows Robert A. Marr and Oded Singer, both in the Laboratory of Genetics at the Salk Institute, Jeffrey M. Redwine at Neurome Inc., Julie A. Ellison, formerly at the Salk, now at Helix Medical Communications, Eric E. Schadt at Rosetta Inpharmatics LLC, Inder Verma, professor in the Laboratory for Genetics at the Salk Institute, David J. Lockhart, co-principal investigator and visiting scholar at the Salk Institute, and Carrolee Barlow, at Braincells Inc.

About Salk Institute for Biological Studies:

Internationally renown for its groundbreaking basic research in the biological sciences, the Salk Institute was founded in 1960 by Dr. Jonas Salk, just five years after he developed the first safe, effective vaccine against polio. The institute's 57-member faculty are scientific leaders in the fields of molecular biology, neurosciences and plant biology.

Cathy Yarbrough
yarbrough@salk.edu
Salk Institute
salk.edu

Migraine - FDA Approves New Formulation Of Imitrex® (sumatriptan Succinate) Injection

Patients Can Now Take a 4mg Dose Using the Convenient Imitrex STATdose System ®; Imitrex Injection Offers Fast Relief for Migraine, Starts Working As Early As 10 Minutes (1).

The United States Food and Drug Administration (FDA) has approved a new formulation of Imitrex Injection that allows a convenient way for patients to take a 4mg dose using the Imitrex STATdose System ®. Imitrex Injection is indicated for the acute treatment of migraines with and without aura in adults.

As many as 28 million Americans suffer from migraine headaches2. Migraines can vary from person to person and from attack to attack, therefore the treatment needs for each attack may also vary. Because relief can mean the difference between debilitating pain and the ability to resume activities of daily life(3), it is important for migraine sufferers to have a variety of treatment options.

Oral treatments can be effective at treating migraine pain for many patients(4), but for certain types of migraine attacks, an alternative delivery system, such as an injection, may be a more appropriate treatment choice(5,6). These attacks include:

-- Morning migraines - when patients awaken with an already moderate to severe headache

-- Approximately 48 percent of migraine attacks occur between 4 a.m. and 9 a.m.5

-- Migraines with nausea and/or vomiting

-- Approximately 92 percent of patients reported experiencing nausea during at least one of their attacks, and approximately 68 percent reported vomiting during at least one of their attacks6

-- Rapidly escalating migraines7

“The availability of Imitrex Injection provides a simple and effective treatment option for patients who experience certain types of migraines,” said Robert Kaniecki, MD, director of The Headache Center at the University of Pittsburgh and assistant professor of neurology. “Migraine patients who experience nausea or vomiting with their headaches often require an injection, since oral treatments are typically not well tolerated by these patients. Additionally, injections bypass the digestive system and enter the bloodstream quickly, which is especially important for treating certain migraine attacks, such as morning and rapidly escalating migraines.”

About the Imitrex STATdose System ®

Imitrex Injection is available in the easy-to-use Imitrex STATdose System , which allows patients to conveniently administer a 4mg dose of Imitrex with just the push of a button. Previously, patients did not have a convenient way to administer doses lower than 6mg by injection.

The Imitrex STATdose System includes two small, disposable cartridges pre-filled with a single dose of Imitrex, and an easy to use autoinjector pen that allows patients to self-administer the medication about one-quarter inch under the skin. With the Imitrex STATdose System patients can treat migraines quickly and conveniently while avoiding direct contact with a needle or syringe.

According to a study published in Headache, 88 percent of patients found the Imitrex STATdose System easy to use (8).

“I've suffered with migraines for the last fifteen years and do not respond well to oral treatments due to the nausea I experience with each attack, so I use Imitrex Injection ,” said migraine patient Kimberly McGonigle. “With the Imitrex STATdose System , I can quickly and easily treat my migraines, so that I can get on with my life.”

About Imitrex Injection 4mg

The efficacy of the 4mg dose of Imitrex Injection was established in three double-blind studies of adult patients with acute migraine, with or without aura.1 In the largest of these studies, 577 migraine patients with moderate to severe migraine pain received Imitrex Injection 4mg or placebo. This study demonstrated that 67 percent of patients received headache relief (defined as reduction in pain from moderate/severe to mild/no pain) within one hour (compared to 25 percent for placebo), and some reported relief starting in 10 minutes.(1)

About Imitrex

Patients should not take Imitrex if they have certain types of heart disease, history of stroke or TIAs, peripheral vascular disease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients with risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes or are a smoker, should be evaluated by a doctor before taking Imitrex. Very rarely, certain people, even some without heart disease, have had serious heart related problems. Patients who are pregnant, nursing, or taking medications should talk to their doctor.

About GlaxoSmithKline

GlaxoSmithKline, with U.S. operations in Philadelphia and Research Triangle Park, N.C., is one of the world's leading research-based pharmaceutical and health care companies. The company is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Please consult full prescribing information, available by calling Robin Gaitens at GlaxoSmithKline at (919) 483-2839

Procedure Allows Women To Freeze Eggs To Preserve Future Fertility

Researchers at the Yale Fertility Center are now offering a cutting edge reproductive procedure called oocyte cryopreservation that allows women to freeze their eggs and use them at a later time to conceive a child.

Pasquale Patrizio, M.D., professor in the Department of Obstetrics, Gynecology & Reproductive Sciences and Director of the Yale Fertility Center, is introducing this technique at Yale in collaboration with an oocyte cryopreservation expert from Bologna, Italy. They will also be researching ways to improve the success of the technology.

Oocyte cryopreservation is aimed at three particular groups of women: those diagnosed with cancer who have not yet begun chemo- or radiotherapy that is toxic for oocytes; those undergoing treatment with assisted reproductive technologies who, for personal reasons, do not consider embryo freezing; and those who do not have a partner and would like to preserve their future ability to have children.

Preparation for oocyte cryopreservation includes consultation, evaluation, and instruction on the use of fertility medications to increase the number of naturally produced eggs. The patient is monitored throughout this outpatient procedure.

Patrizio said the currently reported overall success rate is around two to three babies born per 100 eggs preserved. Compared to conventional in vitro fertilization with non-frozen eggs--eight to nine babies born per 100 eggs--these rates seem low, but are likely to increase as the technique, which is still considered experimental by the American Society for Reproductive Medicine, is refined. Success also depends on the age of the donor--eggs frozen from women before age 35 have a better chance of producing a successful pregnancy.

For patients with cancer, Patrizio, with the help of Emre Seli, M.D., assistant professor in the Department of Obstetrics, Gynecology & Reproductive Sciences, will work with oncologists to help preserve future fertility in younger cancer patients.

"As in the early days of in vitro fertilization, this procedure is still evolving," said Patrizio. "Embryo cryopreservation as an alternative to egg cryopreservation has a higher success rate, but it is not an option for many women."

Those interested in learning more about the procedure may contact Patrizio at 203-764-5866 or Seli at 203-785-7873.

Contact: Karen N. Peart
karen.peart@yale.edu
Yale University

Don't Let Your Children Skip Breakfast

The prevalence of obesity in the U.S. is affecting all ages, both sexes, all ethnic groups and all socioeconomic levels. In general, children are overfed, but undernourished and those who skip breakfast tend to eat more snacks and consume more fat. Studies indicate that 59% of high school students skip breakfast at least three times a week, and one in three girls skip breakfast daily.

“To go eight hours or so, or in the case of some teenagers, longer, without food, I think it's important to recognize that you've got to get those energy stores back up and running right away,” said Robert Murray, MD, of Columbus Children's Hospital and The Ohio State University College of Medicine and Public Health. Murray presented on the importance of breakfast at last month's American Academy of Pediatrics National Conference and Exhibition.

“Breakfast-skippers” are two times more likely to be overweight and they give a variety of reasons for not eating in the morning, including lack of time and/or hunger and “dieting to lose weight.” Experts believe lack of exercise and smoking are also often linked to these reasons. Research shows that nearly all individuals who successfully maintain a weight loss eat breakfast daily. Studies in children and adolescents indicate an association between regular breakfast consumption and lower body mass index. Ironically, breakfast eaters consume more energy per day, yet are less likely to be overweight.

Even periodic, persistent food insufficiency is tied to objective meaures of psychosocial and academic dysfunction. In a study involving six to 11-year-olds from food-insufficient families, the participants were found to have lower arithmetic scores and were more likely to have repeated a grade. Children with poor nutrition during the brain's formative years score lower on tests of vocabulary, reading, arithmetic and general knowledge. Student intelligence and academic performance are affected even in students with malnutrition too slight to manifest in clinical symptoms. Alarmingly, even healthy, well-nourished children who skip breakfast or lunch are less able to distinguish between similar images, have slower memory recall and commit more errors.

Breakfast consumption improves alertness and mood, word recall, short term and spatial memory, and lessens anxiety and irritability. Some studies have even shown that psychosocial function improves as breakfast consumption increases, not to mention improved nutritional status. Studies consistently connect breakfast to improvements in academics, test scores, grades, and less school tardiness and absenteeism.

http://www.columbuschildrens.com

Erectile Dysfunction Linked To Raised Heart Disease Risk

Three studies carried out in the USA and Canada have indicated that there is a clear link between erectile dysfunction (ED) and cardiovascular disease. If you suffer from ED you are much more likely to be suffering from hypertension or diabetes, say the studies.

The older a man is, the more likely he is to have ED. Over 77% of over 75-year-olds suffer from ED, while the figure for men in their 20s is 6.5%.

The causes of ED and heart disease are often very similar. Therefore, ED can be a warning of an existing heart condition in some patients.

Men with ED are much more likely to have a heart attack.

Written by: Christian Nordqvist
Editor: Medical News Today