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From the FDA

FDA Approves Over the Counter Heart Defibrillator

The Food and Drug Administration decided this month that consumers can buy devices to jump-start failing hearts at home without a prescription. Some 80 percent of sudden cardiac arrests occur at home. Before the agency's decision, consumers who wanted a HeartStart home defibrillator to use in those crucial minutes before an ambulance arrived needed a doctor's prescription.

The FDA endorsed a July recommendation from its advisory panel to remove the prescription requirement after federal advisers were satisfied that consumers could use the machines safely. Sudden cardiac arrest differs from a heart attack in that it's an electrical malfunction of the heart that triggers fatally abnormal heart rhythm. Often, it's the first hint of heart disease and accounts for roughly 340,000 deaths outside of health care settings each year.

The shock from a defibrillator is the most effective way to end sudden cardiac arrest, which leaves the victim breathing abnormally and unresponsive. HeartStart delivers a jolt of energy equivalent to what it takes to illuminate a 150-watt light bulb for one second.

When the shock is delivered within five minutes of the sudden cardiac arrest, 50 percent of individuals survive. Ambulances typically arrive within nine minutes of a 911 call. Ten minutes after the sudden cardiac arrest, the patient has a 1 percent chance of survival.

Waiving prescriptions could raise sales beyond 20,000 per year, a volume high enough to cut a few hundred dollars from the $1,995 price tag.

fda.gov/bbs/topics

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Anticoagulation News

FDA Application Pending for Artificial Heart Device

Abiomed Inc. recently submitted an application to the US Food and Drug Administration for approval to market the first self-contained replacement heart. The product, which has been in development for more than 22 years, is a softball size implantable pump that is powered by batteries. Previous mechanical pumps were attached to machinery outside the body. If approved, Abiomed would begin to market the product for use by patients at high risk of death.

The device has been limited in human use to an ongoing, nearly completed clinical trial begun more than three years ago. Fourteen patients have been enrolled so far, with expectations that a 15th and final candidate will be identified soon. The 13th and 14th patients were implanted with the devices in May at Jewish Hospital in Louisville, Ky., and are continuing to recover. All the earlier patients have since died, with two dying during surgery and the rest surviving 54 days to as long as 17 months afterward.

Abiomed said it was not required to enroll the final patient or complete the trial before submitting for approval under the FDA's so-called "humanitarian device" exemption covering novel treatments. If such an exemption is granted, the device could be used in as many as 4,000 U.S. patients each year who are too sick for human heart transplants or any other treatments because of congestive heart failure. Products approved under the exemption do not have to meet the same effectiveness requirements that other products must demonstrate for broader marketing approval. Abiomed hopes to win approval by next March.

boston.bizjournal.com

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Reader's Comments

Report Shows High Blood Pressure on the Rise

A new report showed that as Americans age and become increasingly obese, the percentage of people with high blood pressure has burgeoned. Currently, one in three Americans have high blood pressure, increasing their risks for heart disease, stroke, and kidney failure. The report was published in Hypertension: the Journal of the American Heart Association.

What Is High Blood Pressure?

Blood pressure is the force in the arteries when the heart beats (systolic pressure) and when the heart is at rest (diastolic pressure). It's measured in millimeters of mercury (mm Hg). High blood pressure (or hypertension) is defined in an adult as a blood pressure greater than or equal to 140 mm Hg systolic pressure or greater than or equal to 90 mm Hg diastolic pressure.

High blood pressure directly increases the risk of coronary heart disease (which leads to heart attack) and stroke, especially along with other risk factors.

High blood pressure can occur in children or adults, but it's more common among people over age 35. It's particularly prevalent in African Americans, middle-aged and elderly people, obese people, heavy drinkers and women who are taking birth control pills. It may run in families, but many people with a strong family history of high blood pressure never have it. People with diabetes mellitus, gout or kidney disease are more likely to have high blood pressure, too.

About 65 million American adults now have high blood pressure-30 percent more than the 50 million who did in the previous decade. The report did not specifically examine reasons for the spike, but experts said the aging U.S. population and the growing proportion of overweight and obese Americans are probably major contributors.

The risk of hypertension, or high blood pressure, is increased by old age, excess weight and lack of physical activity. High blood pressure is defined as 140 over 90 or higher. Blood pressure less than 120 over 80 is generally considered ideal. People in between these categories are called pre-hypertensive.

The study found that at least 65 million Americans either have blood pressure in the high range, take blood-pressure lowering medicines or have been told at least twice that they had high blood pressure. Only two out of three people who have high blood pressure know that they do, and only one in three has the condition under control.

hyper.ahajournals.org

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New Treatment

Gels Could Replace Injections

Scientists from India have created, and are now studying, a new gel that could be used in lieu of drugs that are administered as injections. So far, the gel has been tested only in the lab. But if it works similarly in the human body, it could prove useful for delivering drugs to the colon to treat cancer or digestive diseases like Crohn's disease. It might also allow diabetics to take insulin in a pill form rather than injecting it.

The problem in giving drugs to treat these and other diseases is that after being broken down in the stomach, not enough of the drug gets to the target tissue. To help overcome the problem, scientists in India created a synthetic "hydrogel" designed to hold up to stomach acids but yield to the more-alkaline surroundings of the intestines.

In experiments, they found that a hydrogel container holding vitamin B2 largely withstood acidic conditions like those of the stomach, and released most of the vitamin when in a low-acid, colon-like pH. The hydrogel includes as one of its ingredients acrylamide, a chemical that can cause cancer in lab animals. Acrylamide made the news when scientists discovered two years ago that certain cooked foods contain the substance. More detailed investigations of the gel's benefits and potential side effects are necessary before it could be tested with human beings.

wileyeurope.com

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Life Style

Soda Consumption Linked to Diabetes

The average American consumes an astounding 2-3 pounds of sugar each week, which is not surprising considering that highly refined sugars in the forms of sucrose (table sugar), dextrose (corn sugar), and high-fructose corn syrup are being processed into so many foods such as bread, breakfast cereal, mayonnaise, peanut butter, ketchup, spaghetti sauce, and many other fast food products.

Researchers from Harvard University recently identified a possible correlation between soda consumption and diabetes among women. Specifically, women who drink more than one sweetened soft drink a day are more likely to develop diabetes than women who drink less than one each month. A soft drink trade group said the study's conclusions were not scientifically sound, and that the focus should be on the unhealthy lifestyles and weight gain that can lead to diabetes, not soft drinks.

The study involved an analysis of data from a continuing health study of 51,603 female nurses. Researchers analyzed surveys filled out by the nurses in 1991, 1995 and 1999 detailing their eating habits, weight, physical activity and other health issues. There were 741 new cases of type 2 diabetes during the span.

Researchers found that women drinking one or more sugar-sweetened soft drinks a day were twice as likely to develop diabetes as women who drank fewer than one a month. Even when they considered such factors as weight, diet and lifestyle differences, the researchers still found that women drinking sugary sodas were 1.3 times as likely to develop diabetes.

These findings led researchers to suggest that in addition to extra calories, the beverages might also increase diabetes risk because their high amount of rapidly absorbed sugars causes a dramatic rise in glucose and insulin concentrations in the body. Additional research is necessary, however, to study this correlation further.

The health dangers which ingesting sugar on an habitual basis creates are certain. Simple sugars have been observed to aggravate asthma, move mood swings, provoke personality changes, muster mental illness, nourish nervous disorders, deliver diabetes, hurry heart disease, grow gallstones, hasten hypertension, and add arthritis.

Because refined dietary sugars lack minerals and vitamins, they must draw upon the body's micro-nutrient stores in order to be metabolized into the system. When these storehouses are depleted, metabolization of cholesterol and fatty acid is impeded, contributing to higher blood serum triglycerides, cholesterol, promoting obesity due to higher fatty acid storage around organs and in sub-cutaneous tissue folds.

Because sugar is devoid of minerals, vitamins, fiber, and has such a deteriorating effect on the endocrine system, major researchers and major health organizations (American Dietetic Association and American Diabetic Association) agree that sugar consumption in America is one of the 3 major causes of degenerative disease.

Jama.ama-assn.org

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Prevention

MRI Proves Best Screening for Breast Cancer

Magnetic resonance imaging (MRI) is the best way of detecting breast cancer among women with a genetic predisposition to develop the disease. Current recommendations for women who carry a BRCA1 or BRCA2 mutation is to deal with their high risk of breast cancer with regular mammography and clinical breast examination. But many tumors in this group are still detected at a relatively late stage, suggesting there's room for improvement as far as diagnosis is concerned.

A team at the Toronto-Sunnybrook Regional Cancer Center, Toronto, Canada, compared four different methods of breast cancer screening - mammography, ultrasound, magnetic resonance imaging (MRI) and clinical breast examination in a group with BRCA1/BRCA2 mutations. During the period of study, 22 cancers were detected among 236 women. Of these 77 per cent were detected by MRI, 36 per cent with mammography, 33 per cent with ultrasound and 9.1 per cent with breast examination. Therefore addition of annual MRI and ultrasound to mammography and breast examination might be the best way of ensuring early detection of breast cancer among women at genetic risk.

Breast Self-Examination: Your Key to Better Breast Health

Breast self-examination (BSE) takes just a few minutes each month. If you are menstruating, it's best to perform your exam about 7 to 10 days after the first day of your period, when your breasts are least tender. If you no longer menstruate, choose the same day each month to perform BSE.

As you do your examination, keep in mind that your goal is to become acquainted with how your breasts normally LOOK and FEEL. Your knowledge of your breast texture and appearance will increase the more you perform BSE. This knowledge will help you identify a change more quickly, which should be reported to your physician.

A change in your breast does not automatically mean you have breast cancer. But it is best to report any change to your physician for further evaluation.

Mammography is a safe and effective screening tool, finding most breast cancers before they can be felt. But it is important to be examined regularly by your physician in addition to performing monthly breast self-examination.

Inherited genetic mutations in the genes BRCA1 and BRCA2 increase the risk of developing breast cancer, they are very rare and account for only 5%-10% of all breast cancers diagnosed in the U.S. Experts say that surveillance for breast cancer in these high-risk women should include monthly self-breast exam starting at age 20, semiannual breast exams by a health care professional staring between 20-35 years old, and annual mammograms beginning at 25 to 35 years old. For other women, age 40 is the recommended age to begin to screen for breast cancer with mammogram.

nytimes.com

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Fitness Watch

Poll Shows Americans See Themselves as Healthy

Results from a poll commissioned by the University of Texas Health Science Center at Houston found that most Americans see themselves as healthy and are concerned about the rising costs of health care. The nationwide poll on American attitudes about health and health policy was taken to give the health science center and other institutions at the Texas Medical Center the most current public views

In the survey, 1,203 adults were interviewed by telephone at random between Aug. 16 and Aug. 20. The poll's margin of error was plus or minus 2.9 percentage points. The survey had 61 questions about a wide variety of health-related issues. On medical research, 60% said government-sponsored medical research is more important than farm subsidies to protect farmers. Also, the two biggest causes of death in the country - cancer and heart disease - were the two research areas in which people wanted more federal spending.

Nearly two-thirds of Americans support the use of discarded embryos for stem cell research and 72% of those polled support the use of stem cells for finding treatments for Parkinson's disease, Alzheimer's and juvenile diabetes, according to the survey.

While many scientists believe stem cells hold vast promise for treating an array of diseases, some groups oppose the research because the embryos are destroyed in the process. The poll also found that 47% of those surveyed said health care costs were the No. 1 health issue in the country. Obesity was second. The survey also found 66% of respondents had seen their doctor within the last six months.

Pollsters also found results that showed a lack of awareness on the significance of HIV and AIDS as a health problem. While 69% of those surveyed said they were careful about what they eat either most or all of the time, 56% considered themselves to be overweight.

Most of those surveyed expected to live a long time: 20% into their 70s, 42% into their 80s and 18% into their 90s.

medicalnewstoday.com

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Product of the Month

AwareT Breast Self-Exam Kit

The Aware Breast Self-Examination Pad is reusable and guaranteed for the life of the product. The pad also contains a hole near the top so that it may be hung in the bathroom and an opaque bag if women prefer to tuck it in a lingerie drawer. Each pad comes with a five-minute instructional video that demonstrates how to use the pad, written instructions with illustrations, and a list of breast cancer resource organizations.

To help detect breast cancer early, the American Cancer Society recommends the following:

• Starting at age 20, women should practice monthly breast self-exams.
  
• Women between the ages of 20 and 39 should receive a physician-performed clinical breast exam at least every three years.
  
• Starting at age 40, women should receive yearly mammograms, yearly clinical breast exams, and practice monthly breast self-exams.

NOTE: Aware is an aid to breast self-exams. However this product makes no claim to find breast cancer, breast lumps or other breast disease. Aware should be used in conjunction with regular medical visits with your doctor.

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Copyright ©2003 QAS, Inc. All rights reserved. The information provided in this Newsletter and on the Hometestmed site is intended for your general knowledge only and is not a substitute for professional medical advice or treatment for specific medical conditions.