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Value of Mammography (April 25, 2003) 

(Ivanhoe Newswire)

Two new European studies uphold the belief that mammography screening saves lives. One study done in the Netherlands found the introduction of mammography decreased deaths from breast cancer by one fifth. The second study done in Sweden found women who received a mammogram had a 44-percent reduced risk of dying from breast cancer.

There has been a debate on the value of mammography screening over the past few years. In the two current studies, researchers looked at the death rates before mammography was introduced and compared them to after mammography became available.

In the study done in the Netherlands, researchers examined data from nearly 28,000 women between 55 and 74 years old who died of breast cancer between 1980 and 1999. When they compared these statistics from 1986 to 1988 to those after 1997 when mammography was introduced, they found a significant drop in deaths in the later years. In fact, the overall trend of increasing deaths from breast cancer each year was reversed after mammography was introduced. Now, researchers say each year there is a 1.7-percent decrease in breast cancer deaths.

In the second study done in Sweden, researchers compared deaths from breast cancer in two Swedish counties 20 years before and after screening was introduced. Their study included data from 210,000 women diagnosed with breast cancer who were between 20 and 69 years old.

Researchers report women between 40 and 69 years old had a significant reduction in their risk of dying from breast cancer after the screening was offered. However, there was no evidence that improved screening had a significant effect on breast cancer mortality for women younger than 40 years old. Researchers point out this group of women has never been offered mammography. Furthermore, women between 40 and 69 years old who were not screened after screening was available had a 16-percent reduction in death from breast cancer compared with women diagnosed with breast cancer before 1978.

Researchers in both studies conclude mammography screening has contributed to substantial reductions in deaths from breast cancer.

SOURCE: The Lancet, 2003;361:1405-1410

Overweight Raises Cancer Risk destination wl (April 24, 2003) 

ATLANTA (Ivanhoe Newswire)

Most people know being overweight increases the risk for cardiovascular disease. Now, a new study shows increased body weight is also associated with an increased risk of death from cancer.

In 1982, doctors from the Department of Epidemiology and Surveillance Research at the American Cancer Society conducted a study of more than 900,000 adults who did not have cancer. During the 16-year follow-up, more than 57,000 deaths from cancer occurred. Researchers assessed the relationship between body mass index and the risk of death from cancer.

Researchers found the heaviest participants, which included those with a body mass index of at least 40, had death rates from cancer that were 52-percent higher for men and 62-percent higher in women than the rates in men and women who had a normal weight. Specifically, researchers found the increased death rates were associated with cancer of the esophagus, colon and rectum, liver, gallbladder, pancreas and kidney. The same held true for death due to non-Hodgkin’s lymphoma and multiple myeloma. In men, a higher body mass index was also associated with death from cancers of the stomach and prostate. In women, a higher body mass index was associated with death from cancers of the breast, uterus, cervix and ovary.

Researchers conclude the current patterns of overweight and obesity in the United States could account for 14 percent of all deaths from cancer in men and 20 percent of cancer deaths in women.

In an accompanying perspective, doctors from Sweden comment that there seems to be a lack of interest when it comes to programs to prevent cancer by weight control. While they feel more questions need to be answered about the association between weight and cancer, they question whether the public knowing that overweight or obesity is associated with death from cancer will provide the motivation for people to actually lose weight.

SOURCE: New England Journal of Medicine, 2003;348:1625-1638, 348:1623-1624

Lowering Blood Pressure can Help Heart HBP (April 23, 2003) 

BALTIMORE (Ivanhoe Newswire)

A new study shows people who make lifestyle changes to lower their blood pressure also reduce their risk of developing heart disease.

Researchers from the Johns Hopkins Medical Institutions studied more than 800 adults with high blood pressure and hypertension. They divided the patients into three groups. The first group received established recommendations for healthy living. The second received the same recommendations and were put on a specific diet. The third was given advice only and used as a comparison group.

The researchers found that both interventions used on the first two groups significantly reduced weight, increased fitness levels, and lowered sodium intake.

The mean reduction in systolic blood pressure was 10.5 mm HG for the group who received only established recommendations and 11.1 mm HG for the group on the special diet. The comparison group reported a 6.6 mm HG decrease. In addition, the prevalence of hypertension dropped from 38 percent to 26 percent in the advice only group, 17 percent in the group receiving recommendations, and 12 percent in the group on the diet.

Researchers say high blood pressure is a risk factor for cardiovascular disease. Lifestyle modifications that lower blood pressure include weight loss, reduced salt intake, increased physical activity, limited alcohol consumption, and a balanced diet.

If a person’s blood pressure exceeds 140/90, he is considered to have hypertension. Almost 50 million adults in the United States have hypertension and about half of adults 60 and over have it.

Lawrence J Appel, M.D., was quoted as saying, “Ultimately population-wide adoption of healthy lifestyles ... should substantially reduce the societal burden of cardiovascular disease and other chronic diseases.”

SOURCE: Journal of the American Medical Association, April;289:2083-2093

Gene Therapy for Diabetes diabetes (April 23, 2003) 

HOUSTON (Ivanhoe Newswire)

Scientists from Baylor University School of Medicine may be on the road to a promising new way to cure diabetes.

Their animal study of a gene therapy for the disease found the therapy effectively cured mice of their diabetes during the four-month study.

Finding a cure for diabetes is important because current therapies for the disease generally fall short of total blood sugar control. While many new drugs do a fairly good job in this area, patients remain at risk for chronic complications of diabetes. Also, people with diabetes require insulin during the day to keep their blood sugar levels in check.

Gene therapy, according to researchers, so far holds the most promise for those with the disease. Still, methods tested to date have not produced perfect blood sugar control, and recipients have had to remain on long-term immunosuppressive therapy. 

The method tested by these scientists may help solve some of the earlier problems. Using a harmless type of virus known as a helper-dependent adenovirus, or HDAD, they first delivered a pancreatic gene to diabetic mice. This strategy alone, however, caused the mice to develop hepatitis. They then added another factor into the mix -- NeuroD. NeuroD causes the liver to produce cells that make insulin. When NeuroD was combined with betacellulin (Btc), the combination completely reversed the diabetes of the mice without producing hepatitis. All the mice remained healthy and had normal blood sugar levels throughout the study.

The authors conclude, “Our data suggest that NeuroD-Btc gene therapy is a promising regimen to induce islet neogenesis for the treatment of insulin-dependent diabetes.”

SOURCE: Nature Medicine, 2003;9:1-8

Benefits of Tea Explained (April 22, 2003) 

BOSTON (Ivanhoe Newswire)

Many studies have touted the health benefits of drinking tea, but what makes tea so healthy?

According to a new study from researchers at Brigham and Women’s Hospital and Harvard Medical School, certain substances in tea may jump start the immune system, making it better able to fight off infections.

Scientists know human immune cells called T cells mediate our natural immunity to microbes by helping the immune system recognize antigens that are found in tumor cells, bacteria, parasites, and fungi. When introduced into the body, these antigens stimulate the body to produce antibodies to fight off the infection and build up future immunity. These antigens are also found in edible plants, such as tea, apples, mushrooms, and wine. In this study, investigators zeroed in on the way tea generates antigens that impact T cell function.

First, the investigators conducted a cellular study showing how T cells exposed to certain antigens are able to “remember” them if re-exposed. The antigens also fostered a response to whole bacteria and other substances. Investigators then analyzed blood samples from people who drank tea, noting similar results. Substances in the tea primed the T cells to remember the same antigens upon re-exposure and triggered the cells to secrete a substance in response to exposure to bacteria.

The authors conclude, “These data provide evidence that dietary intake of tea and perhaps other vegetables and fruits ... may prime human T cells that then can provide natural resistance to microbial infections and perhaps tumors.”

SOURCE: To be Published in an upcoming issue of Proceedings of the National Academy of Sciences

Why Tumors Resist Drugs (April 22, 2003) 

BALTIMORE (Ivanhoe Newswire)

A new study attempts to shed some light on how cancerous cells develop resistance to the chemotherapy drugs used to kill them.

Resistance to anti-tumor drugs is common in cancer therapy. It can lead to death in many cases because the drugs no longer work to kill the cancer cells. The problem is particularly acute in ovarian cancers that are resistant to the standard drug cisplatin. While the drug is successful against ovarian cancer initially -- with response rates from 40 percent to 80 percent -- relapses of the disease are not so receptive. The majority of patients requiring further treatment with the drug develop tumors that are resistant.

Researchers from the National Institute on Aging conducted a cellular study to find out what makes the tumor cells become resistant to the drug. The culprit: the microenvironment of the cell and, more specifically, the ability of tumor cells to remodel that environment through the production of collagen VI. Collagen VI is a protein produced by ovarian cancer cells. The presence of collagen VI increases resistance of the cancerous cells to chemotherapy drugs.

The authors believe their findings may help find new and better treatments for ovarian and other cancers that become resistant to chemotherapy drugs.

SOURCE: Cancer Cell, 2003;3:377-386

Stem Cells For Heart Disease (April 22, 2003) 

(Ivanhoe Newswire)

A new study shows injecting stem cells directly into heart muscle can effectively and safely treat end-stage heart failure.

Researchers from Texas and Brazil tested 21 patients who suffered with severe heart failure. Fourteen of the patients received an average of 15 injections, containing about 2 million stem cells each. The other seven patients served as a control group. Both groups received the same medical care and monitoring.

After two months, the treated patients showed significantly less heart failure and pumped more blood to the body than the untreated patients. The treated group also performed better on treadmill tests. Four months after the test, the treated patients continued to show improvement.

Researchers aren’t sure why the improvement occurred. James T. Willerson, M.D., from the Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston, says, “Either these stem cells became new blood vessels and new heart muscle cells, or their presence stimulated the development of one or both.”

Dr. Willerson and colleagues began investigating the use of stem cells as a treatment for heart failure about eight years ago. Stem cells are cells that are at an early stage of development and can transform into specific types of cells, such as heart muscle. Once these cells mature into heart muscle, they work to replace the cells that have failed.

Heart failure is the inability of damaged heart muscle to pump enough blood to satisfy the body. About 550,000 new cases of heart failure are diagnosed each year in the United States. In 2000, the disease caused more than 51,000 deaths.

Dr. Willerson says a larger study is needed to accurately identify the risks and benefits of stem cell therapy.

SOURCE: To be published in an upcoming issue of Circulation

Encouraging Fruit and Veggie Consumption (April 21, 2003) 

LONDON (Ivanhoe Newswire)

Counseling low-income people about the benefits of fruit and vegetable consumption can lead to positive changes in their diet, finds a new study from British investigators.

Their report in the current British Medical Journal notes a significant increase in the proportion of people eating five or more servings a day after brief educational sessions delivered in doctors’ offices.

Studies have shown consumption of fruits and vegetables can lower the risk of cancer and heart disease. However, research also indicates people in lower socioeconomic groups are less likely to eat these nutritious foods. Brief counseling sessions have been shown effective in a few reports, but well-designed studies have yet to be conducted.

In this study, investigators enrolled about 270 men and women ages 18 to 70 in a randomized controlled trial. All were in good health and came from inner-city, low-income groups. About half the group received nutrition education counseling in which a nurse instructed them in the benefits of fruit and vegetable consumption, the nutritional content of these foods, and how these nutrients work in the body to keep it healthy. The other half received behavioral counseling. These interventions were tailor-made to the specific individuals, providing personalized advice and emphasizing short-term and long-term goals involving fruit and vegetable consumption.

Participants in the study completed questionnaires about their diet before receiving the counseling and then again at eight weeks and 12 months. They also underwent blood and urine tests to ascertain levels of certain nutrients. 

Results showed positive effects from both interventions, although those in the behavioral counseling group fared the best. By the one-year follow up, the proportion of participants eating five or more servings of fruits and vegetables per day had increased by 42 percent in the behavioral group and 27 percent in the nutrition education group. Blood levels of important nutrients increased in both groups, and there were no changes in urine levels.

SOURCE: British Medical Journal, 2003;326:855-858

Heart Medicine for Bones (April 21, 2003) 

NEW BRUNSWICK, N.J. (Ivanhoe Newswire)

Osteoporosis and low bone mass are a major public health threat for about 44 million Americans age 50 and older. While diet and exercise can help prevent the development of the condition in many, others need more help. Now a common heart medication may be what it takes to keep bones strong.

A healthy bone and the bone of a woman with osteoporosis look entirely different. Each year, the condition causes 1.5 million fractures with nearly $20 billion spent on medical care. “It’s a tremendous public health problem. The most important thing is it’s preventable,” says endocrinologist Sunil Wimalawansa, M.D., Ph.D., of Robert Wood Johnson Medical School in New Brunswick, N.J.

Approved medications, hormone therapy or calcium can slow the natural breakdown of bone. Dr. Wimalawansa hopes the heart medication nitroglycerin will do even more. He says: “This is the only drug that seems to have an effect on the formation at the same time. No other drug has both functions at any given time, so this is unique.”

And it has other benefits.

“It’s about 20-times cheaper than any of the approved drugs right now so economically, it’s good for the patient. Secondly, there are very little adverse effects,” says Dr. Wimalawansa.

Patients like Judy Hanes are excited to have an alternative to hormones.

“I think this method is a little bit healthier than the hormone replacement,” Hanes tells Ivanhoe.

Two hundred study participants in the Nitroglycerin as an Option: Value in Early Bone Loss (NOVEL) study will rub the ointment on their body once a day and take calcium supplements. Regular bone density scans will show how well it works.

Hanes is a health-conscious physical education teacher and does what she can to keep herself well. She says, “I do exercise a little bit with the students by helping them to stretch and become more aware of healthy eating habits, which I do try to follow as well."

And if studies continue to show success, she’ll have another way to keep her bones strong.

The study will continue for three years and will enroll 200 women between ages 40 and 60. The Robert Wood Johnson Medical School is the only study center.

If you would like more information, please contact:

The NOVEL Study Group
UMDNJ -- Robert Wood Johnson Medical School
125 Paterson St., CAB -- 5200
P.O. Box 19
New Brunswick, NJ 08903-0019
(732) 235-8938

novelweb@hotmail.com 
http://www2.umdnj.edu/novelweb/NOVEL 

Osteoarthritis of the Knee -- Web Column (April 21, 2003) 

By Kevin Hwang, M.D., Ivanhoe Health Correspondent

(Ivanhoe Newswire)

Researchers have been busy investigating new treatments for osteoarthritis, also known as degenerative joint disease. Although the cornerstones of therapy remain unchanged, new drugs may able to attack the underlying biochemical abnormalities of this disabling joint condition.

Osteoarthritis is the most common form of arthritis, affecting more than 21 million people in the United States. It is characterized by progressively worsening pain and stiffness in joints. Most patients are elderly or middle-aged, but the disease can occur in those as young as 30 years old. It strikes women more often than men.

The knee is the most commonly involved joint, with more than 10 million Americans suffering from osteoarthritis of the knee. It can also affect the neck, lower back, hips, and fingers. Left unchecked, the disease can completely destroy joints, leaving surgical joint replacement as the only option. Osteoarthritis is ultimately caused by the degeneration of joint cartilage. Biomechanical stress on the joint, biochemical changes in the joint cartilage and surrounding tissues, and genetic factors all contribute to osteoarthritis.

Pain medications, anti-inflammatory agents, and exercise form the foundation for osteoarthritis treatment. Acetaminophen and tramadol are examples of pain medications. Anti-inflammatory agents include nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, celecoxib, and rofecoxib. The latter two represent a new class of NSAIDs associated with less gastrointestinal irritation than the traditional NSAIDs. Local injection of corticosteroids is also considered anti-inflammatory treatment. Together with exercise, these drugs can reduce pain, promote joint mobility, and preserve functional capacity in osteoarthritis sufferers. However, these measures cannot interrupt the actual disease process.

The good news is that researchers are now testing “disease modifying” drugs that may be able to halt or slow the process of joint degeneration. These are also called “structure modifying” drugs as they may be able to affect the structure of osteoarthritic joints. If these drugs are ultimately brought to market, they could become powerful weapons in the treatment of osteoarthritis, focusing on the underlying disease instead of merely controlling symptoms and disability. Roy Altman, M.D., chief of the Division of Rheumatology and Immunology at the University of Miami, says that although the drugs might not be available in the United States for several years, trials in Europe have shown encouraging results.

Other emerging therapies for osteoarthritis include nutritional supplements. These agents are available over the counter but are not regulated by the Food and Drug Administration (FDA). Part of their appeal lies in their perceived “naturalness” and lack of significant side effects. Among the most commonly used supplements are glucosamine and chondroitin.

Due to publicity in the lay press, glucosamine and chondroitin have been gaining popularity among osteoarthritis sufferers in America. Glucosamine and chondroitin are thought to provide the raw materials for building joint cartilage and may also exert an anti-inflammatory effect. Although glucosamine and chondroitin have been used in the treatment of osteoarthritis in Europe for over a decade, they have not yet been widely advocated by physicians in the United States. Initial studies have suggested that these drugs are somewhat effective in reducing symptoms of osteoarthritis, with few side effects, but these studies were small and of varying quality. In a recent edition of The Journal of the American Medical Association, Jess H. Lonner, M.D., Professor of Orthopaedics at the University of Pennsylvania, says, “Few formal, scientifically rigid studies have been performed to determine the efficacy or long-term safety of these supplements.”

To address this issue, the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) is now underway. Funded by the National Institutes of Health, Department of Veterans Affairs, and the National Center for Complementary and Alternative Medicine, this study is currently recruiting osteoarthritis patients, with a goal of approximately 1500 patients. The patients will be randomized to one of five groups: glucosamine, chondroitin, the combination of glucosamine and chondroitin, celecoxib (an anti-inflammatory drug), and placebo. The study will attempt to clarify whether glucosamine, chondroitin, or the combination are effective in improving symptoms of osteoarthritis as well as preserving the structure of affected joints.

Other nutritional supplements have also demonstrated benefit in osteoarthritis. Dr. Altman was lead author and investigator in a study involving ginger extract. In summarizing the main finding of the study, he says that ginger extract “worked almost as well as anti-inflammatories” in reducing the symptoms of osteoarthritis of the knee.

Another relatively new treatment for osteoarthritis is the injection of hyaluronic acid directly into the joint. Hyaluronic acid is the viscous component of joint fluid, acting as a lubricant and shock absorber. Patients with osteoarthritis have subnormal levels of hyaluronic acid in their joints. Theoretically, direct injection of hyaluronic acid into affected joints, especially the knee, may protect the joint and reduce symptoms. It has been approved by the FDA under several trade names for osteoarthritis of the knee. However, some experts question its efficacy. Kenneth Brandt, M.D., head of the Rheumatology Division at Indiana University, states that although some patients seem to have a “spectacular and sustained” response to hyaluronic acid injection, the effect may be similar to injection of saline placebo.

Despite active research in the area of osteoarthritis drugs, the experts emphasize the importance of nonpharmacologic therapy. “Nonpharmalogic measures are the keystone to treatment”, says Dr. Brandt. The fundamental idea is joint protection. Through exercise, weight loss, and learning how to use the affected joints properly, osteoarthritis patients can reduce symptoms and preserve function. This is especially important for large weight-bearing joints like the knee.

Exercise is a vital aspect of joint protection. According to Dr. Brandt, exercise is “very very important” and can maintain or improve joint motion as well as strengthen the muscles that exert force across the joints. This can ultimately slow down the destruction of joints. Examples of beneficial exercises are swimming, biking, and walking.

Exercise can lead to weight loss, which is inherently beneficial in overweight osteoarthritis patients. Dr. Altman states that the simple act of walking causes an “increased impact on the medial compartment of the knee by six fold.” This stress, repeated countless times over decades, can traumatize the knee joint, especially in overweight people. “Not only the number of pounds but also the dynamics of gait” are important in minimizing joint damage. Therefore, periodic gait training is important.

However, regular exercise requires more time, effort, and discipline than simply taking a pill. “It’s effective if people do it,” says Dr. Altman, however, “the major problem with exercise is that people don’t do it.”

Joint protection also involves maintaining good posture, avoiding long periods of inactivity, using proper body mechanics when lifting objects, and wearing good shoes.

If you would like more information on osteoarthritis, please contact:

American College of Rheumatology
1800 Century Place
Suite 250, Atlanta, GA 30345
(404) 633-3777
http://www.rheumatology.org 

Arthritis Foundation
P.O. Box 7669
Atlanta, GA 30357-0669
(800) 283-7800
http://www.arthritis.org 

Hypertension in Pregnancy (April 18, 2003) 

ABERDEEN, Scotland (Ivanhoe Newswire)

Women who suffer from hypertensive diseases during pregnancy may be more likely to have high blood pressure and its related effects later in life, report Scottish researchers publishing in the current British Medical Journal.

Nearly 30 percent of all first pregnancies are associated with gestational hypertension, pre-eclampsia or eclampsia. Little research, however, has been done to assess how these conditions affect a woman’s chance of developing high blood pressure and related problems later in life. While previous studies indicate a link, more research is needed to determine the true risks.

These researchers designed a large-scale, retrospective review aimed at clarifying the association. The study involved nearly 3,600 women who first gave birth between 1951 and 1970. Average age of the mother at delivery was about 24. All were assessed for vital signs and cardiovascular health through a questionnaire, clinical examinations, and analysis of hospital discharge records and mortality data.

Researchers found an increased incidence of high blood pressure among those with gestational hypertension, pre-eclampsia and eclampsia when compared with those without those conditions during pregnancy. Women with the conditions were also more likely to have been admitted to the hospital for diseases related to high blood pressure, and more likely to die from stroke and ischaemic heart disease. The risk of death from stroke was most significant for women who suffered from pre-eclampsia or eclampsia.

The authors believe these findings point to a need for better follow-up care for women with hypertensive diseases of pregnancy. They write, “If greater awareness of this association leads to earlier diagnosis and improved management, there may be scope for reducing a proportion of the morbidity and mortality from such diseases.”

SOURCE: British Medical Journal, 2003;326:845-849

FDA Issues Guidance on Severe Acute Respiratory Syndrome to Further Safeguard the Blood Supply (April 17, 2003) 

FDA today issued guidance to the nation's blood establishments on measures for further safeguarding the blood supply against Severe Acute Respiratory Syndrome (SARS). FDA is taking this interim measure to assure the safety of the blood supply while more is learned about the disease. At this time, it is unknown whether SARS can be transmitted through blood.

Current FDA regulations require that a donor be in good health at the time of donation. Standard procedures already in place should serve as an effective safeguard against donation by a potential donor with symptoms. 

The new SARS guidance sets forth measures for temporarily deferring potential donors who may have been exposed recently to SARS or have experienced acute SARS. These measures include limited additional questioning of potential donors to help ascertain if they may be at elevated risk for SARS, due to recent travel to known high risk areas as defined by CDC or due to exposure to a person with SARS or suspected SARS.

In addition, the guidance calls for blood establishments to actively encourage those who have already donated to report any SARS-related exposure that occurred within 14 days before donation or SARS illness or treatment occurring within 28 days prior to their donation. Donors should also be encouraged to report SARS illness or treatment that occurs within 14 days after donation. Donated units identified as having come from potentially SARS-exposed or infected donors will be quarantined and indefinitely kept out of the general blood supply.

Under the guidance, potential donors who have recently been to areas of the world in which a relatively large number of cases of SARS have been reported (at present, People's Republic of China; Hanoi, Vietnam; and Singapore), but showing no symptoms of the disease, will be deferred from donating blood for 14 days after their return to the US from those endemic areas. Those who have suffered from an acute case of SARS, as evidenced by a combination of symptoms and travel history, will be deferred from donating until 28 days after their symptoms are resolved and any treatment is completed.

The agency recommends that blood establishments implement the guidance as soon as possible and no later than 30 days after its issuance.

Because the guidance only calls for a marginal increase in procedures already in effect to protect the blood supply against other diseases, it is expected to have a minimal effect on the number of available blood donors and on the quantity of the blood supply. Based on current travel estimates, it is believed that 0.1 percent to 0.2 percent of potential donors, and at most 0.4 percent, will be deferred as a result of the guidance at this time.

The guidance reflects consultation with the Centers for Disease Control and is intended as an interim measure to protect against the potential risk to the blood supply posed by SARS. At this time, there are no known cases of SARS transmission via blood products. However, detection of the genes of the possible causative virus in blood has been reported in a patient with SARS. Also, as in some other viral infections, persons with SARS could potentially have virus in their blood early in infection without any symptoms. Therefore, transfusion transmission of SARS may be possible.

FDA will continue to monitor this evolving situation and intends to make any revisions or additions as needed to preserve the safety and availability of the blood supply, based on the best available information. For example, FDA's guidance may be modified based on further scientific research on whether the causal agent of SARS may be present in blood of the types of persons subject to this interim deferral.

Those interested in commenting on the guidance may submit their comment to Dockets Management Branch (HFA-305) Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

As always, FDA strongly encourages eligible donors to give blood regularly. Blood transfusion is often life-saving, and the blood supply is limited. For patients who need blood transfusions, the benefits outweigh the risks.

Prenatal Drinking Dangerous (April 16, 2003) 

SEATTLE (Ivanhoe Newswire)

A new study shows drinking during pregnancy can triple a child’s chances of developing alcohol-related problems in early adulthood.

Researchers from the University of Washington tracked the progress of 433 women and their children since the mid-1970s. The women who participated in the study reported drinking alcohol during their pregnancies, and 31 percent of these women say they drank heavily.

Twenty-two years later, researchers interviewed the mothers and their now-adult offspring. Results show 83 percent of the participants who were exposed to prenatal drinking are current drinkers, while 17 percent say they do not drink at all.

Results of the study also show 14 percent of the young adults who were exposed to heavy prenatal drinking, meaning one or more episodes of five or more drinks, have had alcohol-related problems, compared to just 4.5 percent who were not as heavily exposed.

“This is not a one-to-one relationship, but a mother’s drinking elevates the risk of her offspring having alcohol problems,” says John Baer, Ph.D., of the University of Washington.

Researchers considered other factors, which could have contributed to drinking problems, such as nicotine exposure, gender and family history, but the relationship between prenatal drinking and adult alcoholism still existed.

Researchers plan to continue to follow the families to determine if fetal alcohol exposure leads to more severe alcohol problems in the later stage of adulthood.

SOURCE: Archives of General Psychiatry, 2003;60:377-384

Eye Problems Associated with Heart Problems (April 16, 2003) 

 

MADISON, Wis. (Ivanhoe Newswire)

Retinal abnormalities in non-diabetic elderly persons can be related to high blood pressure. A new study shows high blood pressure and pulse pressure, the higher (systolic) and lower (diastolic) blood pressures, are also associated with an increased incidence of retinal abnormalities, including wet and dry age-related macular degeneration.

One study assessed more than 2,000 non-diabetic patients. The study authors found retinal abnormalities in patients were related to high blood pressure and were associated with heart disease, stroke and carotid artery thickening.

“These [eye] changes may be markers for blood and small vessel diseases of the brain and have been shown to predict stroke independently of standard risk factors. Thus, patients with these changes may benefit from a full cardiovascular assessment,” says Tien Yin Wong, M.D., Ph.D., lead author and visiting assistant professor at the University of Wisconsin-Madison.

A second study found higher systolic blood pressure, the pressure caused by the heart contracting, is associated with progression of age-related macular degeneration and the development of wet macular degeneration.

“Though this study shows that hypertension is associated with the development of advanced age-related macular degeneration, there is a need for further studies to see whether the tight control of blood pressure will reduce the incidence of this form of retinal disease,” explains Ronald Klein, M.D., M.P.H.

Both studies indicate that the eye provides a window to visualize blood vessel abnormalities directly and allows identification of patients who are at high risk for vascular disease.

SOURCE: Ophthalmology, 2003;110:636-643,658-666

FDA Announces Labeling Changes on Heart Benefit Associated With Cholesterol Drug Zocor (April 16, 2003) 

The Food and Drug Administration (FDA) today announced changes to the labeling for Zocor (simvastatin), based on the results of The Heart Protection Study (HPS). The new labeling will reflect research showing that simvastatin is effective in reducing risks of fatal and non-fatal heart attacks, strokes, and in reducing the need for bypass surgery and angioplasty. FDA approved Zocor in 1991 to lower cholesterol. 

The Heart Protection Study was a double-blind, placebo-controlled study conducted in 20,536 patients. Men and women with heart disease or at high risk because of diabetes, peripheral arterial disease, or a history of stroke or other cerebrovascular disease were treated with either simvastatin 40 mg/day or placebo for an average of 5 years. The average age of patients entering HPS was 64 years and the average LDL-C (low density lipoprotein C, or “bad” cholesterol) level at baseline was 131 mg/dL. The trial population included a large number of diabetics and elderly patients. 

The risk of death from coronary heart disease was reduced by 18 percent in the patients treated with simvastatin. The risk of having a non-fatal heart attack was reduced by 38 percent in this group. Simvastatin also reduced the risk of stroke by 25 percent and the need for undergoing coronary or non-coronary revascularization procedures (procedures to unblock clogged arteries) by 30 and 16 percent, respectively. 

The effect of simvastatin to reduce the rate of cardiovascular events was seen in a number of relevant subpopulations of patients enrolled in the trial, including those with and without heart disease, diabetics and non-diabetics, and regardless of gender, age, or baseline cholesterol levels. An important observation in this trial was that patients who had diabetes, peripheral vessel disease, and cerebrovascular disease but who had no evidence of heart disease benefited from taking simvastatin. 

Simvastatin has been shown to be effective in reducing total cholesterol and LDL cholesterol in familial and non-familial forms of hypercholesterolemia (high cholesterol) and in mixed hyperlipidemia –(elevations in both cholesterol and triglycerides).

As with other statins, Zocor should be used in conjunction with a standard cholesterol-lowering diet. The dose of Zocor should be individualized according to the goals of therapy and the patient’s response. The dosage range is 5-80 mg/day. 

As with all statin drug products, patients should be aware of any muscle pain, which may indicate an adverse reaction called rhabdomyolysis, a muscle breakdown disorder. Symptoms can include fatigue, fever, nausea and vomiting, severe muscle pain, weakness and tenderness. Rhabdomyolysis can cause electrolyte imbalances that can result in heart rhythm problems, cardiac arrest, or heart attack. Although the beneficial effects of Simvastatin in HPS were observed with the 40 mg dose, lower doses are recommended in special populations such as those taking certain medications including cyclosporine, verapamil, amiodarone, and other cholesterol-lowering drugs and in patients with kidney problems.

Zocor is manufactured by Merck and Co., Inc. of Whitehouse Station, N.J.

FDA Revises Finding on Estrogen/Androgen Combination Products - In the Treatment of Hot Flashes (April 14, 2003) 


In a proposal that will be published in the Federal Register of April 14, 2003 the Food and Drug Administration (FDA) is beginning a formal administrative process to examine the effectiveness of estrogen/androgen combination products for the treatment of hot flashes associated with the menopause.

FDA is acting because it does not believe there is substantial evidence that androgens contribute to the effectiveness of these combination products to treat hot flashes in menopausal women who do not find relief from these symptoms when using estrogens alone. Estrogen/androgen combination products were found effective for this indication under a determination FDA made in a 1976 Federal Register notice.

FDA is also offering affected parties the opportunity for a hearing on this issue.

FDA is aware of at least two currently marketed products affected by this proceeding: Estratest and Estratest H.S. Neither of these products has been approved.

It has been FDA's long-standing policy to allow the continued marketing of drug products while matters such as these are being resolved, provided there is no documented serious public health or safety issue associated with such products.

It has been FDA's long-standing policy to allow the continued marketing of drug products while matters such as these are being resolved, provided there is no documented serious public health or safety issue associated with such products.

There are also important benefits, however, in demonstrating the safety and effectiveness of new uses for marketed drug products. These benefits include making available to physicians and patients the best information about a drug's safe and effective use. Before such uses can be approved, the manufacturer must submit and FDA must review data from well-planned and executed clinical investigations substantiating the safety and effectiveness of a new use or regimen.

In this case, FDA has determined that the questions about the net benefits of estrogen/androgen combination products require resolution if the long-term availability of such products is to be supported for any use. Today's actions are designed to resolve whether substantial evidence of effectiveness exists for estrogen/androgen combination products for the treatment of hot flashes in menopausal women who do not find relief from these symptoms when using estrogens alone.

FDA encourages the development of clinically meaningful information about new uses of these combination products, including for the treatment of female sexual dysfunction. FDA is willing to work with sponsors interested in conducting clinical trials of drugs for that use (as well as others) and has provided some guidance on the design of clinical trials that could support an application for a drug for the treatment of female sexual dysfunction.

This guidance document is available on the internet at

http://www.fda.gov/cder/guidance/3312dft.htm 

New Guidelines for Vitamin D Intake (April 14, 2003) 

BETHESDA, Md (Ivanhoe Newswire)

The National Academy of Sciences (NAS) now recommends that all infants, including those who are exclusively breastfed, get a minimum of 200 IU of vitamin D per day beginning in the first two months of life.

Rickets, a condition of soft bones, continues to be reported in the United States. It is an example of extreme vitamin D deficiency. Infants who are breastfed and do not receive supplemental vitamin D or adequate sunlight exposure are at increased risk of developing rickets.

Authors of the study write, The recommended adequate intake of vitamin D cannot be met with human milk as the sole source of vitamin D for the breastfeeding infant. Because adequate sunlight exposure is not easily determined, the NAS also suggests the recommended daily dose of vitamin D be continued throughout childhood and adolescence.

One source of vitamin D is from exposure to ultraviolet B light from the sun. Decreased sunlight exposure occurs in winter and from clouds and air pollution. Lifestyles and cultural practices may also limit sun exposure. Recently, the Centers for Disease Control and Prevention and other organizations have launched a public health campaign to decrease the incidence of skin cancer by urging people to limit sun exposure. This combination of factors has led to decreased sun exposure overall and potentially decreased vitamin D synthesis among individuals.

SOURCE: The American Academy of Pediatrics Clinical Report, 2003.

 

Tea Leaves for Metabolic Syndrome? (April 14, 2003) 

SAN DIEGO (Ivanhoe Newswire)

Doctors routinely prescribe weight loss, exercise and a healthy diet to fight Metabolic Syndrome X. Researchers are studying another combative measure. A derivative of the green tea leaf may help with Metabolic Syndrome X, a potentially deadly disorder.

Metabolic Syndrome X is the term used to describe a group of heart disease risk factors, including high levels of abdominal fat, bad cholesterol, high blood pressure, and abnormal glucose metabolism. Also known as Insulin Resistance Syndrome, Metabolic Syndrome X is thought to occur in people with a family history of type 2 diabetes. Researchers say excessive caloric intake is one of the root causes.

Chinese researchers found Tegreen, a tea product, improves glucose and lipid metabolism, enhances insulin sensitivity and balances the metabolic rate of fat deposit and fat burning in obese rats.

Researchers studied 44 female rates divided into four groups. The first group received a normal diet and a normal-diet placebo. The second group received a high-calorie diet and a high-calorie diet placebo. The last two groups were given Tegreen at doses of 25 mg/kg or 75 mg/kg.

Investigators found blood sugar decreased by 21.5 percent for the group given the low dose of Tegreen and decreased 15.7 percent for the group given the high dose. Fat relative to body weight also decreased 11.9 percent in the low-dose group and decreased 21.6 percent in the high-dose group.


SOURCE: Experimental Biology 2003, San Diego, April 11-15, 2003

 

Partial Knee Replacement  (April 14, 2003) 

NEW YORK (Ivanhoe Newswire)

Anyone who has arthritis of the knee knows how painful it can be. While medication can help, major surgery is often the only way to get complete relief. Now there's another option. 

Last summer, a severe case of arthritis in his knee made it impossible for Ed Schultz to put on his shoes. A scan of his knee confirmed the problem. "There was no cartilage at all, no cushioning of any kind between the bones. When I'd walk, it was a mortar and pestle grinding away at each other," Schultz tells Ivanhoe.

Until recently, fixing the problem would have meant total knee replacement. Because only part of Schultz's knee was affected, orthopedic surgeon Michael Bronson, M.D., recommended a far less invasive option -- a partial knee replacement.

"In a unicompartmental replacement, what we're doing is just resurfacing that area which is worn out," Dr. Bronson, of Lenox Hill Hospital in New York, tells Ivanhoe.

A metal runner and small plastic disc replace the worn cartilage, providing a new cushion between the bones. The forty-five minute procedure requires a much smaller incision than a total knee replacement, has less blood loss, and a faster recovery.

Dr. Bronson says, "Whereas in total knee replacement, we talk about recovery being three to six months. In these operations, we're talking about weeks."

Even more encouraging is that the improvement lasts.

"The data that are just coming back after 10 years shows that 95 percent of patients are still functioning as they did in the beginning, which is an excellent long-term prognosis," he says.

Schultz says, "I really have, I believe, virtually full mobility with the knee." If he's like the others, it will continue.

Dr. Bronson recommends partial knee surgery for anyone over 50, and if a total knee replacement is needed later, he says it's easier to do. 

If you would like more information, please contact:
Michael Bronson, M.D.
Lenox Hill Hospital
(212) 734-2646
sagasports@aol.com

 

FDA Approves New Rapamune Labeling Likely to Improve Transplanted Kidney Functioning (April 11, 2003) 

The Food and Drug Administration (FDA) today announced the approval of revised labeling for Rapamune(sirolimus) that will allow new kidney transplant patients at low to moderate immunologic risk of organ rejection to stop taking cyclosporine 2 to 4 months after transplantation. By substituting higher levels of Rapamune for cyclosporine, it is hoped that kidney function will improve.

Today’s action is the first approval of a cyclosporine-sparing regimen for new kidney transplant patients. Currently, all kidney transplant patients are treated with a combination of medications -- typically three or more immunosuppressant drugs -- to prevent organ rejection. 

More than one-half of all new kidney transplant patients could potentially benefit from this newly approved regimen. In the year 2000 alone there were 14,427 kidney transplants in the United States, according to the U.S. Renal Data System, a project of the National Institute of Diabetes & Digestive & Kidney Diseases at the National Institutes of Health.

The combined use of Rapamune and cyclosporine is necessary but may carry long-term risks to the transplanted kidney function. The ability to take kidney transplant patients off cyclosporine 2-4 months after transplantation, without increased risk of organ rejection, is therefore likely to be associated with improved kidney function.

FDA based its decision on the results of a randomized, multi-center controlled clinical trial that enrolled 525 patients. This study assessed the safety and efficacy of Rapamune as a maintenance regimen, comparing patients who were administered Rapamune, cyclosporine and corticosteroids continuously with patients who received the same standardized therapy for the first 3 months after transplantation followed by the withdrawal of cyclosporine. At 12, 24 and 36 months after transplantation, organ and patient survival were similar for both groups.

Clinical research is currently underway to assess the safety and efficacy of cyclosporine withdrawal in new kidney transplant patients at high-risk of organ rejection, as well as kidney transplant patients who have been taking a combination of immunosuppressive medications for more than 4 months. Therefore, cyclosporine withdrawal and concentration controlled Rapamune use is not being recommended at this time in these additional patient populations.

Wyeth Pharmaceuticals Inc., of Philadelphia, Pa., is the sponsor of the approved New Drug Application (NDA) for Rapamune. 

 

Limiting Stroke Damage (April 11, 2003) 

DALLAS (Ivanhoe Newswire)

Caffeinol, a new medication that combines caffeine and ethanol, shows signs of limiting stroke-induced brain damage in animal studies and has been proven safe in a small pilot study of stroke patients.

Rats treated with caffeinol within three hours after an artery supplying blood to the brain was obstructed had up to 80-percent reduction in the size of their brain lesions.

These studies, says James C. Grotta, M.D., “…demonstrated that the combination of caffeine and ethanol might reduce the amount of damage after stroke. Neither caffeine nor alcohol offered protection alone, but the combination was protective.

Dr. Grotta and colleagues from the University of Texas-Houston sought to determine the safety and tolerability of caffeinol in humans in this study. They gave caffeinol to 23 stroke patients. “Our goal was to see if we could safely achieve the same blood levels of caffeinol that we achieved in our animal studies,” says Dr. Grotta. They discovered that they were able to use even lower doses than in animals and achieve the same protective effect.

Researchers do not yet know how caffeinol works to protect the brain. A randomized, placebo-controlled trial is needed to determine the neuroprotective effect of caffeinol. Other studies have suggested that cooling the brain may limit stroke damage. Dr. Grotta plans a study that combines caffeinol with thermo-cooling in stroke patients.

SOURCE: To be published in an upcoming issue of Stroke.

 

Exercise Advice Helps (April 11, 2003) 

AUCKLAND, New Zealand (Ivanhoe Newswire)

A new study shows advising patients about exercise is effective in increasing physical activity and improving quality of life.

Researchers in New Zealand used the “green prescription” program to test 878 sedentary individuals.

The program helps primary care doctors educate their patients about the benefits of exercise. Doctors discuss healthy exercise behaviors with patients and then give them a green prescription card that highlights their fitness goals. The patients are further advised over the telephone for a three-month period.

Researchers involved in this study divided the patients into two groups. One group received advice about exercising by using the green prescription program, while the other did not.

The advised group showed an increase in physical activity during leisure time. This group also reported higher energy levels and a better self-rated measurement. They gave themselves improved ratings in the general health, bodily pain, and vitality categories.

The counseled group also saw a decrease in blood pressure, but no changes in the risk of coronary heart disease were observed. Researchers say this study is the first of its kind to find a link between exercise counseling and better physical health.

The study proves that advice, coupled with ongoing telephone support, can change a person’s exercise habits. Researchers say widespread implementation of the green prescription program could result in major health benefits for sedentary people.
SOURCE: British Medical Journal, 2003;326:793-796

 

Antioxidant Helps Diabetic Nerve Damage (April 10, 2003) 

ROCHESTER, Minn. (Ivanhoe Newswire)

A new study shows consuming the antioxidant alpha lipoic acid (ALA) can significantly improve symptoms of diabetic neuropathy. Neuropathy is nerve damage that can result as a complication of diabetes. It affects about 50 percent of patients.

Researchers from the Mayo Clinic and a medical center in Russia tested 120 patients with diabetes who suffered from neuropathy. The patients received either ALA or a placebo for three weeks, and all participants were given a placebo during the fourth week.

Researchers measured the severity of patients’ pain by using a total symptom score system. Those who took ALA saw a 5.7-point total improvement, while those on placebo only improved by 1.8 points.

Researchers say these results show ALA significantly improves the frequency and severity of diabetic neuropathy symptoms, which may include burning and sharply cutting pain, prickling sensations and numbness.

Prior to this study, the alternatives for managing symptoms of diabetic neuropathy were narcotics, analgesics and antiepileptic drugs, which all have considerable side effects. ALA produced no unfavorable side effects in patients in this study.

ALA is available over the counter, in oral form, and in small doses. Peter Dyck, M.D., of the Mayo Clinic, warns against putting too much faith in the drug. He says: “It may well be worthwhile for treatment, but I’d rather patients not go out swallowing large amounts of this drug yet. It isn’t FDA-approved for this purpose.”

Dr. Dyck adds that a large, multi-center trial of oral ALA is underway. He says, “We should see what the further data show before we give this widely to patients with diabetic neuropathy.”

SOURCE: Diabetes Care 2003;26:770-776

 

Another Reason to Eat Fish (April 1, 2003) 

BOSTON (Ivanhoe Newswire)

Women with diabetes who eat more fish have healthier hearts, find Harvard University researchers.

A study of more than 5,000 women taking part in the Nurses' Health Study showed as much as a 64-percent drop in the risk of heart disease in women who ate fish five or more times a week when compared to those who ate fish less than once a month.

Studies conducted among healthy people have linked consumption of fish with lower risks of heart disease. The omega-3 fatty acids in fish have numerous benefits for the heart. Not only do they reduce the risk of irregular heartbeats, they also improve the function of blood vessels, decrease blood triglycerides, and minimize blood clots. Researchers have been unsure if this protection extends to people with diabetes, who are at high risk for heart disease.

Researchers divided women in the study into five groups depending on how much fish they said they ate each week on a dietary questionnaire. Results show a steady decline in heart disease risk as consumption of fish rose. Women who ate fish one to three times a month had a 30-percent reduced risk compared to those who ate fish less than once a month. Those who ate fish once a week had a 40-percent reduced risk, and those who ate fish two to four times a week had a 36-percent reduced risk.

Lead researcher Frank B. Hu, M.D., from the Harvard School of Public Health, concludes, "Regular fish consumption should be considered as part of a healthy diet for diabetes management. For individual patients, at least two servings of fish per week are recommended."

SOURCE: To be published in an upcoming issue of Circulation.

 

Could Vitamin C Repair the Heart? (April 1, 2003)

BOSTON (Ivanhoe Newswire)

Researchers say vitamin C may one day be used to help heal damaged hearts.

Researchers from Harvard Medical School have found ascorbic acid (vitamin C) turns stem cells into heart cells in mice. Vitamin C was the only one out of 880 bioactive substances, such as vitamins and drugs, to have such an effect.

"Although the findings of this study are very preliminary with respect to their impact on human lives, this line of research has enormous implications for the future care of thousands of patients who develop heart failure each year," says Robert O. Bonow, M.D., president of the American Heart Association. He adds, "Identifying mechanisms to transform stem cells into differentiated heart muscle cells is an important step toward clinical reality."

In the study, scientists genetically altered the stem cells of mice to emit a green glow if they became heart muscle cells after exposure to the various substances. Vitamin C repeatedly proved able to induce the green glow in the stem cells. The study also showed signs of two important heart cell proteins in the altered cells, along with three heart muscle genes.

Researchers say the implications of the study are vital to the more than 550,000 people who develop heart failure each year, a condition which arises when the heart muscle becomes damaged and is no longer adequately able to pump blood. Doctors have long believed lost heart muscle could never be replaced, but this study holds hope for a reversal of that damage. Lead study author Richard T. Lee, M.D., says, "We are excited about anything suggesting that we can grow more heart cells."

SOURCE: To be published in an upcoming issue of Circulation.

 

Blood Sugar, Blood Pressure and Heart Attacks (April 1, 2003)

UPPSALA, Sweden (Ivanhoe Newswire)

Swedish researchers have linked an increase in blood sugar levels while using common blood pressure medications leads to an increased risk of heart attack in men age 60 and over.

Several studies show patients with high blood pressure are more resistant to insulin than are patients without high blood pressure, and treatment with common high blood pressure medications, such as beta-blockers and diuretics, increases this insulin resistance. Since diabetes and impaired glucose tolerance are both associated with an increased risk of heart disease, investigators decided to measure the impact of blood pressure, blood glucose levels, and high blood pressure treatment in 1,860 men who participated in a health study at age 50.

Each of the men underwent additional tests at age 60 and then were followed for about 17 years. Those who had heart attacks after age 60 showed significantly larger increases in blood glucose between ages 50 and 60 than those without heart attacks. An increase in blood glucose was found to be an independent risk factor for heart attack in men who were being treated for high blood pressure, but not in men without such treatment. In addition, researchers found a significant link between markers of insulin resistance at the baseline testing and high blood pressure treatment on the increase in blood glucose.

Investigators believe their findings show the metabolic changes induced by high blood pressure treatment have a definite impact on heart attack risk.

SOURCE: British Medical Journal, 2003;326:681-684.

 

Pregnancy and Uterine Fibroids (April 1, 2003)

SALT LAKE CITY (Ivanhoe Newswire)

Researchers say a treatment for uterine fibroids is also helping women conceive.

Uterine fibroids are benign tumors that can cause prolonged, heavy menstrual bleeding that can lead to conditions such as anemia, urinary frequency and pain during intercourse. Fibroids often interfere with fertility and frequently cause miscarriages. Uterine fibroid embolization is a newer treatment that has become more widely available in the United States in the past five years. The treatment works by cutting off the blood supply to the fibroids causing them to shrink.

The Ontario Uterine Fibroid Embolization trial is a large multi-center trial involving more than 500 women. Researchers say this treatment was not intended to treat infertility caused by uterine fibroids, but they say a surprising number of successful pregnancies have occurred in women in the trial. At the study follow-up, 17 women reported 19 pregnancies -- two had two pregnancies each. All of the women had large fibroids and many had previous miscarriages. Twelve of the 17 women did not have children before uterine fibroid embolization. Researchers also say most of these women had been previously advised to have a hysterectomy to treat their fibroids.

Gaylene Pron, Ph.D., lead author of the study, says, "Miscarriage is a particularly traumatic event for women with fibroids. One of the women who had a healthy baby after UFE had, had nine prior miscarriages. These are particularly good results for these women, who were older women with a history of fibroids and infertility." She goes on to say, "This study does show that successful pregnancies can occur after uterine fibroid embolization."

SOURCE: Society of Interventional Radiology Annual Scientific Meeting in Salt Lake City, March 27 - April 1, 2003.

 

Gauging Skin Cancer Risk from Moles (April 1, 2003) 

BOSTON (Ivanhoe Newswire)

How worried should you be that a mole will turn into the most deadly form of skin cancer?

That's the question researchers attempted to answer in a new study published in this month's Archives of Dermatology.

Using data on the number of melanoma skin cancer cases each year and the number arising from moles, researchers found the risk of any mole turning into melanoma is small. The annual transformation rate of any single mole was 0.0005 percent or less for both men and women under age 40. That translates to about one case in 200,000. The transformation rate rises significantly, however, for men over age 60, to 0.003 percent, or one in 33,000. Still, the lifetime risk at age 20 of any mole developing into melanoma by age 80 is about 0.03 percent (one in 3,164 for men and 0.009 percent (one in 10,800) for women.

Researchers believe these findings suggest there is a low risk of moles turning into melanoma, especially in younger people, and say excision of benign-appearing moles in people with no other associated risk factors is of limited benefit. They also believe photographic documentation of all moles on young, low-risk people -- also known as "mole mapping" -- may not be worth the expense of the procedure, since the chance of any one mole ever developing into melanoma is so low.

While the incidence of melanoma has been on the rise in recent decades, the investigators point out earlier detection is leading to greater cure rates for the condition. The American Cancer Society reports only about 7,400 deaths among 53,600 cases of melanoma in 2002.

SOURCE: Archives of Dermatology, 2003;139:282-288.

 

Liver Injury from Diabetic Medications (March 31, 2003) 

OAKLAND, Calif. (Ivanhoe Newswire)

A new study links the use of diabetic medications with an increased risk of acute liver injury or failure.

Medical literature regularly reports on cases of drug-induced liver injury. Doctors are asked to report any suspected cases to manufacturers or regulatory authorities to assist in the evaluation of medication safety after FDA approval. One diabetes medication, troglitazone, was withdrawn from the market in both the United States and the United Kingdom after case reports suggested it causes liver damage. Since diabetes itself can cause liver problems, larger studies are needed to accurately assess the risk of medications used to treat the disease.

In this study, researchers reviewed medical records from about 171,000 patients age 19 and older when they first received oral hypoglycemic drugs or insulin to control their diabetes. The analysis identified 26 cases of acute liver failure and 9 cases of acute liver injury that could not be clearly attributed to a known cause other than use of the diabetes medications. Twenty-seven additional cases, however, had a possible alternative cause, including exposure to hepatotoxic drugs. Just one of the cases had no apparent cause other than the use of the hypoglycemic agent, and that patient was on tolazamide. Eight of the patients died during hospitalization.

The incidence of toxic events was similar for the various medications in the study, and individuals with other chronic diseases besides diabetes were at higher risk of developing complications. The authors write, "Acute liver failure or injury not clearly attributable to other known causes occurred on the order of 1 per 10,000 person-years among diabetic patients treated with oral hypoglycemic drugs or insulin."

SOURCE: Archives of Internal Medicine, 2002;163:728-734.

 

Family History and Breast Cancer (March 31, 2003) 

MANCHESTER, England (Ivanhoe Newswire)

British researchers say doctors need to do a better job of routinely asking their young breast cancer patients about their family history of breast and/or ovarian cancer. They also say it's important to note the history in their medical records -- a task they say is often overlooked.

Three gene mutations -- BRCA1, BRCA2, and TPS3 -- have been linked to familial and early-onset breast cancer. Lifetime cancer risk for those with these genes is estimated at between 43 percent and 85 percent. Once they get the cancer, those with BRCA1 or BRCA2 mutations are also at increased risk for subsequent tumors, and those with the TPS3 gene carry a higher risk for radiation-induced tumors. Identifying women at high risk for these genetic mutations is, therefore, paramount to effectively treating their disease.

In a research letter in the most recent issue of The Lancet, investigators from St. Mary's Hospital in Manchester detail a study involving 99 young women ages 30 and under who were diagnosed with breast cancer. Investigators questioned all women about their family history of breast and ovarian cancer and tested for the gene mutations. They also looked in their medical records to see if doctors had noted their family history during previous visits.

Investigators found a strong family history in about a third of the women, but in more than half of these cases, the history did not appear in hospital notes. Forty-four percent of the women with strong family histories were found to carry one of the genetic mutations. Just six percent of those without a family history had such genetic anomalies.

Lead author Fiona Lallo, M.D., from St. Mary's Hospital, notes, "Our findings underline the importance of accurate elucidation of a family history from young women with breast cancer for the prediction of mutations ... we recommend that all breast cancer surgical notes include a section on family history, which has to be completed."

SOURCE: The Lancet, 2003;361:1101-1102.

 

Watch Your Mouth (March 31, 2003) 

LOS ANGELES (Ivanhoe Newswire)

Though they may not see their doctor that often, more than 50 percent of people in the United States say they've been to their dentist within the last six months. Those visits to the dentist might be keeping more than just your teeth in good shape.

Meet the dentists of tomorrow -- students learning to identify, and repair, whatever is wrong inside a patient's mouth. These students are also learning to "think outside the mouth" to notice signs of bigger health problems.

"There's a lot of bacteria, fungi, in the mouth, and if we have a compromised immune system for any reason, then that will be clearly evident in the oral cavity," says Craig Woods, D.D.S., a dentist at the University of California, Los Angeles.

When the bacteria in your mouth create problems with your teeth and gums, it may mean your immune system isn't working properly. "Conditions that can cause that can be things like diabetes, AIDS," says Woods.

In addition, cancer can spread from inside the body to inside the mouth, where a dentist can spot it. Because most people tend to see their dentists more frequently than they see their doctors, a standard dental exam could be a lifesaver.

Patient Melisa Daniels says, "This pain has been giving me headaches, and if there was something else wrong, I would be very glad to know. Because I don't go to the doctor that often."

So, while your dentist is no substitute for a general practitioner, he or she can be an extra set of watchful eyes.

Once a dentist notices an unusual condition that might point to a bigger problem, the patient is urged to see his or her doctor. All modern dentists are trained to recognize health problems that present symptoms in the mouth.

If you would like more information, please contact:

Michelle Popowitz
UCLA School of Dentistry
Box 951668
Los Angeles, CA 90095-1668
(310) 206-7094

mpopowitz@dent.ucla.edu
http://www.dent.ucla.edu