Saturday, June 23, 2007
Fake Colgate Toothpaste
Jun 15 - Colgate-Palmolive Co. said on Friday that counterfeit toothpaste falsely labeled as "Colgate" posed a low health risk, and the company said it was picking up the suspected fakes from small independent stores in four U.S. states.
Colgate has contacted all of its accounts to ensure they have no fakes, the company added.
The counterfeit toothpaste, containing the toxic chemical diethylene glycol, is labeled as being manufactured in South Africa and comes in a 5-ounce tube, a size Colgate does not sell in the United States.
Higher Risk of Stroke in Women
June 21, 2007 — A new study using data from the National Health And Nutrition Examination Survey (NHANES) shows the risk for stroke among US women between the ages of 45 and 54 years is more than double that of men the same age.
Independent predictors of stroke risk in this age group included the presence of coronary artery disease and increased waist circumference, suggesting that poor risk-factor control in these women may be to blame for the increased risk.
"Women aged 45 to 54 had twice the odds of having experienced stroke compared with men of the same age, and the transition from age 35 to 44 to 45 to 54 marks the steepest rise in stroke prevalence for women," lead author Amytis Towfighi, MD, from the Stroke Center and department of neurology at the University of California, Los Angeles, told Medscape.
Their study also showed that from 1999 to 2004, stroke prevalence rates rose in women while they declined in men.
The results are published online June 20 in Neurology. Their findings were presented earlier this year at the American Stroke Association International Stroke Conference 2007 and reported by Medscape at that time.
Poor Risk-Factor Control?
Although the majority of strokes occur in older age groups, those in midlife, between the ages of 35 and 64 years, are still at risk, Dr. Towfighi pointed out. Women under the age of 65 years have risk factors particular to their gender, including risks associated with pregnancy, the use of oral contraceptives and hormone replacement therapy, and a higher prevalence of migraines.
"Understanding gender-specific differences in the frequency and predictors of stroke in midlife years is important, which is what prompted us to look into this," Dr. Towfighi said.
For this study, they used NHANES data from 1999 to 2004 on 17,061 men and women to look at sex differences in stroke prevalence and identify independent risk predictors among middle-aged individuals. Stroke was identified through the in-home interview portion of the survey, where subjects were asked if they had ever been told by a physician that they'd had a stroke.
Of the 17,061 men and women surveyed, 15,309 responded to the question about stroke (90%). Of these, 606, or 4%, reported having experienced a stroke, 51% of whom were men and 49% women.
Based on these data, they found that women between 45 and 54 years had significantly higher odds of having had a stroke compared with men of the same age group.
The Cost of Diabetes Treatment
The staggering cost of treating diabetes and the number of diabetes-related programs highlight a need for a national diabetes coordinator to ensure results," Haza said. "We are spending as much on diabetes as we are on the entire Department of Education, but no one is leading the effort."
A report by Medco Health Solutions Inc. issued last month found that the growing diabetes epidemic and more aggressive treatment could result in soaring costs to treat the disease over the next three years.
An analysis of Medco's 2007 Drug Trend Report found that, by 2009, spending just on medicines to treat diabetes could soar 60 percent to 68 percent from 2006 levels. The sales of diabetes drugs in the United States reached $9.88 billion in 2005, according to data from IMS Health Inc.
"Coordinating America's response to diabetes should be mandatory," said Lana Vukovljak, CEO of American Association of Diabetes Educators.
"Over the next 30 years, diabetes is expected to claim the lives of 62 million Americans. Surely this health crisis warrants the appointment of a manager charged with aligning budgets and programs for diabetes at the federal level," Vukovljak said in a statement.
Uncontrolled diabetes can result in a wide variety of serious health complications, including heart disease, stroke, vision loss, amputation of extremities and kidney disease.
"Our findings suggest that there are many missed opportunities for the federal government to enhance its impact on diabetes prevention, detection, treatment and management of complications," Marsha Gold, who led Mathematica's research team, said in a statement.
Symptoms of Ovarian Cancer
In response to reports by patients with ovarian cancer of the symptoms they experienced, Dr. Goff and others have found that certain symptoms are much more frequent in women with ovarian cancer than in women in the general population. These symptoms include bloating, pelvic or abdominal pain, difficulty eating or feeling full quickly, and urinary symptoms of urgency or frequency.
"The symptoms are not specific, and all of us have had 1 or more of these symptoms from time to time," Dr. Goff says. "What's different about the symptoms of ovarian cancer is that they are new symptoms, not symptoms you have had all your life; they occur regularly, either daily or every other day; and they persist more than several weeks."
The consensus panel recommended that women who experience these symptoms almost daily for more than a few weeks should see their doctor, preferably a gynecologist, because prompt medical attention might allow diagnosis at the earliest possible stage of ovarian cancer, when prognosis is better. Because there is no effective screening test for ovarian cancer, symptom recognition and regular pelvic examinations are essential for early detection.
"We are not 100% sure that identification of symptoms will lead to earlier detection of ovarian cancer, but because there is a potential for that, we need more research to see what effect implementing this statement will have on outcomes," Dr. Goff says. "Even in stage 1, which is associated with a 90% cure rate, women have these symptoms. If women are having these symptoms even in early stages, then with recognition of these symptoms, we may be able to diagnose ovarian cancer in early stages when chance of cure is 70% to 90%, as opposed to the 20% to 30% chance of cure in advanced stages."
Although other symptoms are often reported by women with ovarian cancer, such as fatigue, indigestion, back pain, pain with intercourse, constipation, and menstrual irregularities, these symptoms are not as helpful in diagnosing ovarian cancer because they are found in equal frequency in women without ovarian cancer in the general population.
A nationwide poll conducted by GCF in May 2007 revealed that women agree that it is important to know the symptoms of ovarian cancer, but 65% did not feel sufficiently informed. There is therefore a great need for information dissemination and education of women and healthcare providers.
"By highlighting these symptoms and their potential association with ovarian cancer, more women may seek medical attention, especially if these symptoms persist over a few weeks," Dr. Barakat said. "Since ovarian cancer is much less common than other cancers, such as breast and lung cancer, patient education has lagged behind. Increasing public awareness could potentially lead to more patients being diagnosed with early-stage disease, and potentially lead to fewer deaths from ovarian cancer."
Dr. Barakat also highlighted the need for additional research on laboratory screening tests.
"One of the most important areas of research in this disease should be the development of novel biomarkers that can detect early ovarian cancer," he says. "Currently, the best test we have is a CA-125 blood test. This tumor marker is only elevated in 50% of patients with early ovarian cancer and has not been shown to be an effective screening tool in this disease."
"Our goal is not to scare people, but to arm people with the knowledge that if these symptoms persist, they could be a sign of ovarian cancer or other serious condition," Dr. Goff concludes. "If ovarian cancer is suspected because of these symptoms and a suspicious mass is detected, it is very important for the woman to see a gynecologic oncologist. In that situation, if there is ovarian cancer, women are significantly more likely to have the right surgery and a higher chance of cure, so it could mean the difference between life and death."
Saturday, June 16, 2007
FDA Site for Tweens - Reducing Obesity
Spot the Block
Using the Nutrition Facts Label to Make
Healthy Food Choices -- A Program for Tweens
http://www.cfsan.fda.gov:80/~dms/spotov.html
Monday, June 04, 2007
New, Continuous 7-Day Blood Sugar Tracking
FDA Approves Continuous 7-Day Glucose Monitoring System
The U.S. Food and Drug Administration today approved a device that measures glucose levels continuously for up to seven days in people with diabetes.
While a standard fingerstick test records a person’s glucose level as a snapshot in time, the STS-7 Continuous Glucose Monitoring System (STS-7 System) measures glucose levels every five minutes throughout a seven-day period. This additional information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn’t be captured by fingerstick measurements alone. However, diabetics must still rely on the fingerstick test to decide whether additional insulin is needed.
“The STS-7 System supplements standard fingerstick meters and test strips, providing diabetics ages 18 and older with a way to see trends and track patterns,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “It can help detect when glucose levels drop during the overnight hours, show when glucose levels rise between meals and suggest how exercise and diet might affect glucose levels.”
The STS-7 System, manufactured by DexCom Inc. of San Diego, Calif., uses a disposable sensor placed just below the skin in the abdomen to measure the level of glucose in the fluid found in the body’s tissues (interstitial fluid). Sensor placement causes minimal discomfort and can easily be done by patients themselves. The sensor must be replaced weekly. An alarm can be programmed to sound if a patient’s glucose level reaches pre-set lows or pre-set highs.
Diabetes is caused by the body’s inability to produce or use insulin, a hormone that unlocks the cells of the body, allowing glucose (sugar) to enter and fuel them.
An estimated 20.8 million people in the United States—7 percent of the population—have diabetes. Most have type 2 diabetes, a condition in which the body does not properly use insulin. An estimated 5 percent to 10 percent of people with this chronic disease have type 1 diabetes, which results from the body's failure to produce insulin. People with type 1 diabetes must take insulin every day.
Diabetes can lead to wide fluctuations in blood sugar levels. Over time, abnormally high levels of glucose can damage the small and large blood vessels, leading to diabetic blindness, kidney disease, amputations of limbs, stroke, and heart disease.
While there is no known cure, studies have shown that patients who regularly monitor and regulate their blood glucose levels have lower incidences of complications associated with the disease.
FDA’s approval of the STS-7 System was based on results of a study conducted by DexCom of 72 patients with diabetes at five clinical sites in the United States. The study demonstrated that the STS-7 System was safe and effective for detecting trends and tracking patterns in glucose levels in adults.
A three-day version of the device, the STS Continuous Glucose Monitoring System, was approved in March 2006.