Radiotherapy Centers of Georgia in Partnership with Northside Hospital Present Breast Health & Cancer Awareness Day

Educating the Community on Breast Cancer Awareness October 2, 2010

Have you checked your breasts today? In 2009, the American Cancer Society estimated approximately 40,170 women died from breast cancer. In Georgia, an estimated 5,840 women will be diagnosed with breast cancer and 1,140 women will die from the disease this year. October is Breast Cancer Awareness Month and Radiotherapy Centers of Georgia – Cherokee County, in partnership with Northside Hospital-Cherokee, is presenting the 2nd Annual Breast Health & Cancer Awareness Day on Saturday, Oct. 2, 2010 at the Northside Hospital–Cherokee Conference Center, located at 1130 Bluffs Parkway in Canton, GA 30114.

“Breast Cancer is the leading cause of cancer death in women behind lung cancer,” said Sandra Gregory, M.D., radiation oncologist of Radiotherapy Centers of Georgia – Cherokee County. “It is a disease which is 100 percent treatable if caught early, so it is important to be educated and aware.”

The 2nd Annual Breast Health & Cancer Awareness Day will begin at 10 a.m. and run until 2 p.m., with featured lectures from renowned female physicians and breast specialists -- moderated by Sandra Gregory, M.D. The day’s activities will feature three panels addressing three crucial topics for women: Wellness and Prevention, Latest Treatment and Technology and Recent Developments in Breast Cancer.

Each panel consists of some of the best and brightest in their field. Peahen Gandhi, M.D., OB/GYN, Courtney Sinclair, M.D., GYN and Angela Falany, M.D. will discuss wellness and prevention; Anita Johnson, M.D., Breast Surgeon, Angela Robbins, M.D., Breast Surgeon and Lynn Baxter, M.D., Diagnostic Radiologist will speak towards the latest treatment and technology; and the third panel on recent developments in Breast Cancer will feature Rosa Langella, M.D., Breast Surgeon, Kathleen Long, M.D., Medical Oncologist, Gena Volas-Redd, M.D., Medical Oncologist and Sandra Gregory, M.D., Radiation Oncologist.

This free education event is an opportunity for women of the community to learn about genetic testing, partial breast irradiation, diet and nutrition, changes in surgical management of breast disease and breast cancer prevention. Northside Hospital’s ScreenAtlanta mobile mammography van will be onsite performing mammograms and attendees will also have an opportunity to sign up with StoryCorps Atlanta to go in-studio and record their personal experiences with Breast Cancer.

“Women who have been diagnosed or have loved ones who have been diagnosed are always the most eager to learn every last detail about Breast Cancer. But it is just as important, if not more important for those who are not as aware to be educated and proactive in getting screened,” said Dr. Gregory.

Breakfast, a survivor program and luncheon will be provided with a special butterfly release to honor all those who have fought and won the cancer battle. The 2nd Annual Breast Health and Cancer Awareness Day is free and open to the public. Registration is recommended, but only required for those requesting mammograms. To register, please call 404-845-5555 and press “0,” Monday through Friday from 8:30 a.m. to 4 p.m.

Sponsorship opportunities are still available. For more information on Breast Cancer Symposium 2010 or sponsorship opportunities, contact Toni Karasik at 678-965-4756 x. 115 or e-mail tkarasik@rccancercenters.com.
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FDA Approves ella(TM) Tablets for Prescription Emergency Contraception

/PRNewswire/ -- The U.S. Food and Drug Administration today approved ella(TM) (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.
An FDA Advisory Committee for Reproductive Health Drugs discussed ella in June, 2010. The committee unanimously voted that the application for ella provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.

The safety and efficacy of ella were demonstrated in two Phase III clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.

Side effects most frequently observed with ella in the clinical trials include: headache, nausea, abdominal pain, pain/discomfort during menstruation (dysmenorrhea), fatigue, and dizziness. The profile of side effects for ella is similar to that of FDA-approved levonorgestrel emergency contraceptives.

According to the product's labeling, women with known or suspected pregnancy and women who are breastfeeding should not use ella. A patient package insert also will be provided to ensure that women are fully informed of the benefits and risks involved in the use of ella.

ella is manufactured by Paris-based Laboratoire HRA Pharma. ella will be distributed by Watson Pharma Inc., of Morristown, N.J.

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FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women

The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis.

People with osteoporosis at high risk for fracture include those that have had an osteoporotic fracture, or have multiple risk factors for fracture; or those who have failed or are intolerant to other available osteoporosis therapy. Prolia works to decrease the destruction of bone and increase bone mass and strength. An injection of Prolia is recommended once every six months.

“Due to its prevalence, osteoporosis is a serious concern to public health,” said Julie Beitz, M.D., director of the FDA’s Office of Drug Evaluation III. “The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.”

The safety and efficacy of Prolia in the treatment of postmenopausal osteoporosis was demonstrated in a three-year, randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the study, Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

The most common side effects reported with Prolia include back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcaemia (low calcium levels in the blood), serious infections, including infections of the skin, and dermatologic reactions such as dermatitis, rashes, and eczema.

Prolia causes significant suppression of bone turnover and this suppression may contribute to the occurrence of osteonecrosis of the jaw, a severe bone disease that affects the jaw, atypical fractures, and delayed fracture healing.

Prolia was approved with a risk evaluation and mitigation strategy (REMS) that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of the drug.

Prolia is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks, Calif.-based Amgen Inc.

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Older Women with Diabetes Face Higher Risk for Colon Cancer

(BUSINESS WIRE)--A research team led by Mayo Clinic physicians has found that older women with diabetes face a more than doubled risk for some types of colorectal cancer. The findings are being presented at Digestive Disease Week 2010, the annual meeting of the American Gastroenterological Association.

Colorectal cancer (http://www.mayoclinic.org/colon-cancer/) remains the third-leading cause of cancer deaths among women in the United States. Diabetes has been identified as a colon cancer risk factor, but the mechanisms aren’t completely understood. For this population-based cohort study, researchers examined data from 37,695 participants of the Iowa Women’s Health Study (IWHS), which enrolled women ages 55–69 in 1986 and remains ongoing. Of these women, 2,361 reported a diagnosis of Type 2 diabetes and 1,200 developed colorectal cancer.

To find the links between colorectal cancer and diabetes, the researchers worked with regional pathology laboratories to obtain tumor tissue samples from IWHS participants who were diagnosed with colorectal cancer. They linked the tissue samples with other IWHS data, looking for cancer pathways and risk factors, and whether those risk factors were associated with three different molecular markers: microsatellite instability (MSI), CpG island methylation (CIMP), and BRAF gene mutations.

“Diabetes was more strongly associated with the MSI-high, CIMP-positive and BRAF-mutation cancer subtypes in this group of older women,” says Mayo Clinic gastroenterologist Paul Limburg, M.D. (http://www.mayoclinic.org/bio/10658084.htm). Dr. Limburg explains that diabetes appeared to confer a greater than twofold increase in risk for these molecularly-defined tumors, compared to women without diabetes.

“Knowing that diabetic women have these findings should help to facilitate more appropriate colorectal cancer prevention and treatment options,” says Anthony Razzak, M.D., a Mayo Clinic research fellow and presenter at the conference. “Our findings may lead to new strategies for colon cancer screening, chemotherapy and chemoprevention in women with diabetes.”

“From a research perspective, this information allows us to clarify how environmental exposures and other risk factors might effect tumor formation at a molecular level,” says Dr. Razzak. For future projects, the researchers will work to understand more about the biology of colorectal cancer and how it is influenced by diabetes, as well as other chronic conditions and exposures. They hope to use that information to improve patient care.

“Unfortunately, diabetes and colon cancer are both very common in the United States, so making links between these disorders has substantial public health implications,” says Dr. Limburg.

Mayo Clinic’s Division of Gastroenterology and Hepatology (http://www.mayoclinic.org/gi-rst) has been ranked No. 1 in the U.S. News & World Report Honor Roll of Top Hospitals since the rankings began 20 years ago.

Collaboration

The study was funded by the National Cancer Institute. Additional Mayo Clinic co-authors are Amy Oxtenko, M.D.; Robert Vierkant; Lori Tillmans; Alice Wang; Susan Slager, Ph.D; Thomas Smyrk, M.D.; Stephen Thibodeau, Ph.D.; and James Cerhan, M.D., Ph.D. Co-authors from other institutions are Daniel Weisenberger, Ph.D., and Peter Laird, Ph.D., both of the University of Southern California Epigenome Center; Charles Lynch, M.D., Ph.D., University of Iowa College of Public Health, Iowa City; Kristin Anderson, Ph.D., and Lisa Harnack, Ph.D., both of the University of Minnesota Cancer Center, Minneapolis; Robert Haile, Ph.D., of the University of Southern California School of Medicine, Los Angeles; and John Potter, M.D., Fred Hutchinson Cancer Research Center, Seattle.

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Radio Frequency Energy Used to Shrink Fibroids and Reduce Symptoms in New Minimally Invasive Procedure

/PRNewswire/ -- Montefiore Medical Center recently became the only hospital on the East Coast to conduct the Radio Frequency Ablation procedure to shrink uterine fibroids in women 30 years and older. This minimally invasive procedure, initially used to treat liver cancer, uses a tiny needle that is inserted into the fibroid, applying low energy radio frequency electrical current, which creates localized tumor destruction by heat.

"More than 30% of all women suffer from fibroids, which can cause excessive menstrual bleeding and pain," said Erika Banks, MD, Director of the Fibroid Center at Montefiore and lead investigator of the study. "This procedure is another option for these women who wish to preserve their uterus -- an important advantage of this minimally invasive procedure."

Fibroids are benign tumors, which grow in the uterus. Fibroids are the most common tumor in the reproductive years, and are 2-3 times more common among African American women. Symptoms include heavy and or painful menstrual bleeding, a feeling of pressure in the pelvis, frequent urination, pain during intercourse, abdominal bloating and abdominal pain and/or back ache.

Montefiore is one of only five medical centers in the U.S. to test this procedure. The other centers are in California, Arizona, Michigan and Missouri. This study is currently enrolling women with fibroids and heavy bleeding who no longer desire fertility.

Treatment of 235 fibroid tumors in 70 women outside the U.S. resulted in significant reduction of symptoms and improvement in quality of life for about 90% of women, according to Dr. Banks.

Montefiore Medical Center encompasses 126 years of outstanding patient care, innovative medical "firsts," pioneering clinical research, dedicated community service and ground-breaking social activism. A full-service, integrated delivery system caring for patients in the New York metropolitan region and beyond, Montefiore is a 1,491-bed medical center that includes: four hospitals -- the Henry and Lucy Moses Division, the Jack D. Weiler Division, the North Division and The Children's Hospital at Montefiore; a large home healthcare agency; the largest school health program in the US; a 23-site medical group practice integrated throughout the Bronx and Westchester; and a care management organization providing services to 179,000 health plan members.

In 2008, The Children's Hospital at Montefiore was ranked as one of "America's Best Children's Hospitals" in US News & World Report's prestigious annual listing and also received honors in the magazine's 2009 edition. The Leapfrog Group lists Montefiore among the top one percent of all U.S. hospitals based on its strategic investments in sophisticated and integrated healthcare technology.

Montefiore is committed to meeting the healthcare needs of the future through medical education and manages one of the largest residency programs in the country. Montefiore is The University Hospital and Academic Medical Center for Albert Einstein College of Medicine and has an affiliation with New York Medical College for residency programs at the North Division.

Distinguished centers of excellence at Montefiore include cardiology and cardiac surgery, cancer care, tissue and organ transplantation, children's health, women's health, surgery and the surgical subspecialties. Montefiore is a national leader in the research and treatment of diabetes, headaches, obesity, cough and sleep disorders, geriatrics and geriatric psychiatry, neurology and neurosurgery, adolescent and family medicine, HIV/AIDS and social and environmental medicine, among many other specialties. For more information, please visit MACROBUTTON HtmlResAnchor www.montefiore.org or www.montekids.org .

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Annual CDC Report Finds High Burden of Sexually Transmitted Diseases, Especially Among Women and Racial Minorities

Reported cases of chlamydia and gonorrhea in the United States exceeded 1.4 million in 2007, according to an annual report (http://www.cdc.gov/std/stats07/) by the Centers for Disease Control and Prevention. These diseases continue to be the most commonly reported infectious diseases in the nation and pose persistent and preventable threats to fertility in the United States.

The report, Sexually Transmitted Disease Surveillance, 2007, shows persistent racial disparities across these and other sexually transmitted diseases (STD), and a particularly heavy burden of disease among women. The report also finds continued increases in syphilis. This disease, while once on the verge of elimination, began re-emerging as a threat in 2001 and increased 15.2 percent between 2006 and 2007.

"The widespread occurrence of these diseases should serve as a stark reminder that STDs remain a serious health threat in the United States, especially for women and racial and ethnic minorities," said John M. Douglas, Jr., M.D., director of CDC's Division of STD Prevention. "Left untreated, chlamydia and gonorrhea can cause infertility, affecting a woman's chance to bear children later in life. Such a severe consequence is entirely avoidable, if as a nation we work together to increase the use of proven prevention tools and make them widely available to those who need them."

Women Bear Heavy STD Burden, Including Risk of Infertility

Women continue to bear a disproportionate burden of the long-term health consequences of STDs. In 2007, the chlamydia rate among women was three times that of men (543.6 cases per 100,000 women, compared to 190 cases per 100,000 men). The gonorrhea rate was also higher among women (123.5 per 100,000 women, compared to 113.7 per 100,000 among men).

Although the two diseases can be easily diagnosed and treated, they often have no symptoms and go undetected. If left untreated, up to 40 percent of chlamydia and gonorrhea infections in women can result in pelvic inflammatory disease -- a condition that causes as many as 50,000 women to become infertile each year. Untreated chlamydia or gonorrhea can also cause ectopic pregnancy, chronic pelvic pain, and other serious health problems.

The report found that there were more than 1.1 million chlamydia cases reported in 2007, up from about one million in 2006, making it the largest number of cases ever reported to CDC for any condition. Gonorrhea, the second most commonly reported infectious disease, had more than 350,000 cases reported in 2007. However, it is estimated that more than half of all new infections with chlamydia and gonorrhea continue to go undiagnosed, underscoring the importance of increased screening. CDC recommends annual chlamydia screening for all sexually active women under 26 years old, and supports U.S. Preventive Services Task Force recommendations to screen high-risk, sexually active women for gonorrhea.

STDs Take Heaviest Toll on Racial Minorities, Especially Black Women

CDC's 2007 STD surveillance report also indicates ongoing racial disparities in the three most common reportable STDs, with African-Americans bearing the greatest burden. While representing 12 percent of the U.S. population, blacks had about 70 percent of reported gonorrhea cases and almost half of all chlamydia and syphilis cases (48 percent and 46 percent respectively) in 2007.

STDs take an especially heavy toll on black women 15 to 19 years of age, who account for the highest rates of both chlamydia (9,646.7 per 100,000 population) and gonorrhea (2,955.7 per 100,000 population) of any group. STDs in this age group are of particular concern because of the potential threat of these two diseases to a woman's fertility.

Studies have shown that one of the most important social determinants of sexual health is socioeconomic status. Higher rates of poverty among blacks than whites, and socioeconomic barriers to quality healthcare and STD prevention and treatment services have been associated with higher prevalence and incidence of STDs among racial and ethnic minorities.

"The racial disparities in rates of STDs are among the worst health disparities in the nation for any health condition," stressed Douglas. "We must intensify efforts to reach these communities with needed screening and treatment services. Testing and the knowledge of infection is a critical first step toward reducing the continued consequences of these diseases."

Growing Threat of Syphilis

Syphilis, a disease close to being eliminated as a public health threat less than a decade ago, has increased each year since 2000 and remains a serious threat to the health of gay and bisexual men.

In 2007, men who have sex with men (MSM) continued to account for the majority of primary and secondary (P&S) syphilis cases, representing 65 percent of the 11,466 P&S syphilis cases reported. Increased transmission among MSM is believed to be the primary driver of increased rates of syphilis overall in the United States. Syphilis among MSM is of particular concern because it can facilitate HIV transmission and lead to irreversible complications such as strokes, especially in those who already have HIV. CDC recommends that all MSM be tested for syphilis at least annually.

Additionally, while P&S syphilis continues to occur at substantially lower levels among women than men (1.1 cases per 100,000 among females compared to 6.6 among males), syphilis rates have been increasing among women and infants in recent years, reversing years of decline in these populations. Syphilis rates among women have increased since 2004, and the rate of congenital syphilis increased for the second consecutive year in 2007. Because untreated syphilis can be transmitted from a pregnant woman to her infant and result in stillbirths, infant deaths, or severe complications in children who survive, CDC recommends that all women be screened for syphilis during the early stages of pregnancy.

Intensified Efforts Needed to Address Significant Gaps in STD Prevention

To reduce the toll of STDs and protect the health of millions of Americans, expanded prevention efforts are urgently needed. CDC estimates that almost 19 million new sexually transmitted infections occur each year, and almost half of those are among 15- to 24-year-olds. In addition to the threat of infertility, increased risk of HIV acquisition, and other health risks, STDs also have a substantial economic impact. CDC estimates STDs cost the U.S. health care system as much as $15.3 billion annually.

CDC supports a comprehensive approach to STD prevention through screening, treatment, and behavioral interventions, with a focus on reducing health disparities, especially those occurring among racial and ethnic groups. To further progress against the most widespread reportable STDs, CDC, along with the Partnership for Prevention and eight other leading STD organizations, recently established the National Chlamydia Coalition. CDC also has been working with partners and community leaders across the nation on syphilis elimination efforts since 1999, yet successes in some areas and populations continue to be offset by increases in others, as programs must continually shift efforts to address emerging needs. Ultimately, successful elimination of this disease will require intensified efforts at the federal, state and local level to reach the diverse and expanded populations now at risk.

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Why Bladder Cancer Is Deadlier for Some

/PRNewswire-USNewswire/ -- Bladder cancer is much more likely to be deadly for women and African-Americans, but the reasons long believed to explain the phenomenon account for only part of the differences for such patients compared to their white and male counterparts, according to results published in the Jan. 1 issue of the journal Cancer.

The results present a stark question for doctors and patients: If age, tumor type, and stage of the disease upon diagnosis don't account for all the increased lethality of the disease in women and African-Americans, then what does?

It's a gaping question facing researchers who have long confronted an irony of bladder cancer, the fifth-most-common type of cancer in America. The disease is more lethal in those patients who are less likely to get it.

Men are more than three times as likely as women to get the disease, and white people are nearly twice as likely to get the disease as African-Americans. Yet, once the disease is present, it's far deadlier in women and in African-Americans -- anywhere from 73 percent to 114 percent more deadly in the first year after diagnosis, depending on the group.

In the Cancer paper, scientists and physicians at the University of Rochester Medical Center show for the first time that the factors traditionally thought to be responsible for the differing course are responsible for only about one-third of the difference between white men and women, and up to two-thirds of the difference between African-Americans and their white counterparts.

"We've known that the disease is likely to be more advanced in women and African-Americans by the time they're diagnosed," said corresponding author Edward Messing, M.D., a surgeon well known for his expertise in treating patients with bladder cancer. "Like many doctors, I long assumed that the delay in diagnosis was the reason why the disease is more deadly for these patients.

"I was surprised to find that recognized factors like a delay in diagnosis explain only part of the difference. There are clearly other important factors at work that make these patients more likely to die from the disease. There could be something different about the cancer itself, or there could be differences in the ways these groups are treated," said Messing, who is professor of Urology and Oncology as well as leader of the Prostate Cancer and Genitourinary Oncology team at the James P. Wilmot Cancer Center.

To do the study, scientists analyzed the records of more than 100,000 patients who were diagnosed with bladder cancer from 1990 to 2003. Their records are part of a national cancer registry known as SEER (Surveillance, Epidemiology, and End Results). The 101,249 patients came from 16 different regions: Atlanta, rural Georgia, Connecticut, Detroit, Seattle, Hawaii, Iowa, New Mexico, San Francisco, Los Angeles, San Jose, rural California, Kentucky, Louisiana, New Jersey, and Utah.

The statistical analysis was done by first author Emil Scosyrev, a graduate student in epidemiology; Katia Noyes, Ph.D., associate professor of Community and Preventive Medicine; and Changyong Feng, Ph.D., assistant professor of Computational Biology and Biostatistics. The work was funded by the Ashley Family Foundation.

The team found that in the first year after diagnosis, women were anywhere from about 80 percent to 114 percent more likely to die from the disease than their male counterparts. That increase was a bit lower in year two, when women were about 52 to 55 percent more likely to die.

When it came to race, the researchers found that African-Americans were about 73 percent to 103 percent more likely than their white counterparts to die from the disease within the first two years after diagnosis, and about 40 percent to 117 percent more likely to die three or four years after diagnosis.

Then the team sifted through the data to try to uncover the reasons behind these differences. The team found that the factors traditionally thought to be responsible for the differences -- stage of the disease upon diagnosis, tumor type, and age -- accounted for only about 30 percent of the difference between the genders among white people, and about 50 to 70 percent of the differences between the races and between the genders among African-Americans.

"The current study by Scosyrev et al elegantly demonstrates that, even after controlling for tumor characteristics, inferior outcomes remain for African-American patients and women," write physicians Mark Katz, M.D., and Gary Steinberg, M.D., of the University of Chicago Medical Center in an editorial accompanying the findings.

The authors speculate about other factors that might be responsible for the differences, though they say that further study is necessary to know for sure. Some of the other issues that might play a role include the choice of treatment chosen, differences among tumors that were not taken into account in the study, and access to health care.

Messing believes that poorer access to health care is a clear cause of the higher mortality rates for African-Americans. He says African-American patients and their doctors need to be aware of the increased chance of death for these patients, who should be treated as aggressively as possible.

When it comes to gender, some of the differences are likely caused by factors that are not currently understood, such as hormonal differences, says Messing. But a factor that is known to play a key role is people's reaction when they see blood in their urine. Men are more likely than women to notice blood in their urine, to think it's abnormal, and to report it to doctors -- and even then, when it is reported, doctors are 65 percent more likely to refer men than women to urologists.

The authors say that women who find blood in their urine need to be vigilant about having the cause checked as quickly as possible. In women with bladder cancer, sometimes treatment is delayed while doctors investigate other potential causes of blood in the urine. While that is often a sign of a urinary tract infection or something other than cancer, Messing says it's crucial for doctors to consider bladder cancer as a potential cause right from the start.

"People need to be especially vigilant about blood in the urine," said Messing. "Be sure to report it to your doctor, and be sure the doctor investigates the cause thoroughly."

The American Cancer Society estimates that in 2007, 67,000 people in the United States were newly diagnosed with bladder cancer, and 13,700 patients died of the disease.

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Georgia State Study First to Pinpoint Why Analgesic Drugs May be Less Potent in Females than in Males

Investigators at Georgia State University’s Neuroscience Institute and Center for Behavioral Neuroscience are the first to identify the most likely reason analgesic drug treatment is usually less potent in females than males. This discovery is a major step toward finding more effective treatments for females suffering from persistent pain.

“Opioid-based narcotics (such as morphine) are the most widely prescribed therapeutic agents for the alleviation of persistent pain; however, it is becoming increasingly clear that morphine is significantly less potent in women compared with men. Until now, the mechanism driving the phenomenon was unknown,” said Anne Murphy, a Georgia State Professor of Neuroscience and member of the Center for Behavioral Neuroscience, who conducted the research with Dayna Loyd.

Murphy recently solved the mystery with findings printed in the December issue of The Journal of Neuroscience that show that previously reported differences in morphine’s ability to block pain in male versus female rats are most likely due to sex differences in mu-opioid receptor expression in a region of the brain called the periaqueductal gray area (PAG).

Located in the midbrain area, the PAG plays a major role in the modulation of pain by housing a large population of mu-opioid receptor expressing neurons. Morphine and similar drugs bind to these mu-opioid receptors analogous to a ‘lock and key’ and, ultimately, tell the brain to stop responding to pain signals to the nerve cells resulting in the reduced sensation of pain.

Using a series of anatomical and behavioral tests, Murphy and Loyd were able to determine that male rats have a significantly higher level of mu-opioid receptors in the PAG region of the brain compared with females. This higher level of receptors is what makes morphine more potent in males because less drug is required to activate enough receptors to reduce the experience of pain. Interestingly, when they used a plant-derived toxin to remove the mu-opioid receptor from the PAG, morphine no longer worked, suggesting that this brain region is required for opiate-mediated pain relief.

Additional tests also found females reacted differently to morphine depending on the stage of their estrous cycle. These findings indicate that steroid hormones may affect mu-opioid receptor levels in the region of the PAG that are essential for analgesia and also suggest that the actions of morphine are estrous stage-dependent.

“Interestingly, sex is not the only factor that has been shown to affect the potency of various pharmacological agents. Recent studies have reported an influence of age and ethnicity, and further argue for the inclusion of a wide range of study subjects in pain management research,” Murphy said. “In addition, despite the rapidly mounting evidence regarding the limitations of opiates in treating persistent pain, opioid-based drugs remain the primary pharmacological tool for pain management. Clearly additional research with the inclusion of female subjects needs to be devoted to determining a more potent treatment for persistent pain in women.”

Murphy’s work was supported by grants from the National Institutes of Health.

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FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs

The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease. Bayer Women's is also labeled for use in "fighting" osteoporosis. Neither product has been approved by the FDA for such uses. These drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC).

"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."

Bayer Heart Advantage combines aspirin and phytosterols in a single tablet. Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug. According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol and the calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis. Although certain calcium-containing dietary supplements may bear claims to reduce the risk of osteoporosis, products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval. Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease. Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.

Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling and formulation, as well as the indications (uses) for which the drugs can be marketed. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. Bayer Heart Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. Therefore, Bayer Heart Advantage and Bayer Women's are unapproved new drugs.

In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are misleading. Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits. The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.

"The marketing of these unapproved drugs is troubling," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."

Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.

Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States.

Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products.

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U.S. Suicide Rate Increases

The rate of suicide in the United States is increased for the first time in a decade, according to a new report from the Johns Hopkins Bloomberg School of Public Health’s Center for Injury Research and Policy. The increase in the overall suicide rate between 1999 and 2005 was due primarily to an increase in suicides among whites aged 40-64, with white middle-aged women experiencing the largest annual increase.

Whereas the overall suicide rate rose 0.7 percent during this time period, the rate among middle-aged white men rose 2.7 percent annually and 3.9 percent among middle-aged women. By contrast, suicide in blacks decreased significantly over the study’s time period, and remained stable among Asian and Native Americans. The results are published online at the website of the American Journal of Preventive Medicine and will be published in the December print edition of the journal.

The researchers also conducted a detailed analysis of suicide methods across specific population groups. While firearms remain the predominant method, the rate of firearm suicides decreased during the study period. Suicide by hanging or suffocation increased markedly with a 6.3 percent annual increase among men, and a 2.3 percent annual increase among women.

Hanging/suffocation accounted for 22 percent of all suicides by 2005, surpassing poisoning at 18 percent.

“The results underscore a change in the epidemiology of suicide, with middle-aged whites emerging as a new high-risk group,” said study co-author Susan P. Baker, MPH, a professor with the Bloomberg School’s Center for Injury Research and Policy. “Historically, suicide prevention programs have focused on groups considered to be at highest risk—teens and young adults of both genders as well as elderly white men. This research tells us we need to refocus our resources to develop prevention programs for men and women in their middle years.”

Baker along with colleagues Guoqing Hu, PhD, Holly Wilcox, PhD, Lawrence Wissow, MD, MPH, analyzed data from the Web-based Injury Statistics Query and Reporting System (WISQARS) mortality reports, which provides data on deaths according to cause and intent of injury by age, race, gender and state. WISQARS mortality data are based on annual data files of the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC).

The reasons for the increase in the suicide rate are not fully understood. “While it would be straightforward to attribute the results to a rise in so-called mid-life crises, recent studies find that middle age is mostly a time of relative security and emotional wellbeing,” said Baker. “Further research is warranted to explore societal changes that may be disproportionably affecting the middle-aged in this country.”

The research was funded by the Center for Injury Research and Policy.

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Big Waistline in Women Could Lead to Heart Trouble

A heart expert at Johns Hopkins is calling for all women with a waistline measuring more than 35 inches to get an annual check-up and detailed risk assessment for heart problems because excess abdominal fat, even in the mildly obese and overweight, leads more than a third of women to underestimate their lifetime risk of having a heart attack, stroke or chest pain (angina.)

Cardiologist Erin Michos, M.D., M.H.S., who plans to make her pitch Sept. 23 directly to colleagues during a special lecture at The Johns Hopkins Hospital, says the recommendation is based on a national, multicity screening of 8,936 women, ages 35 to 63, for heart disease risk factors. The screening, she says, found a strikingly high number of overweight American women whose stretched girth was tied to a serious underestimation of risk using traditional tools to assess heart health.

In a report published in the August issue of the Journal of Women’s Health, the research team showed that 39 percent of women screened were overweight (having a body mass index between 25 and 30) and 35 percent were obese (having a body mass index over 30, often overweight by more than 30 pounds.) And when waistlines 35 inches and larger were factored into the risk assessment, 55 percent of these women were found to have hearts at increased risk of disease.

“It is time for physicians and patients to pull out their measuring tapes and for overweight women in particular to start shedding some pounds,” says Michos, an assistant professor at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute.

She points out that traditional risk-factor scoring leaves out waist size, taking into account only such other factors as age, blood pressure, blood cholesterol levels, smoking and diabetes. These measures have long been used as part of the Framingham Risk Assessment, which only assesses people’s 10-year risk of heart disease.

But the team’s latest assessments – drawn from a 2006 annual public screening in 14 communities across the United States, in which women were asked to undergo a short physical check-up and fill out a health questionnaire – changed significantly when expanded waistlines were factored into their calculations.

More than half (59 percent) of the 85 percent of women originally thought to be at low risk of heart trouble were now found to have one or two additional risk factors. And 19 percent of those at low risk and nearly half (41 percent) of the women originally ranked at intermediate risk actually had three or more risk factors.

“These women have a high lifetime risk of cardiovascular disease even though their 10-year risk may be predicted as low,” says Michos, who points out that the presence of a single, major risk factor for heart disease by the age of 50 cuts back on women’s median lifespan compared to women with no risk factors.

“Our results really emphasize the growing epidemic of obesity in America and showcase its potential for misreading or masking future harm to women’s heart health,” she says. “Even if they are not experiencing immediate problems, they could soon be in trouble. Overweight people are more likely to develop risk factors that lead to cardiovascular problems, such as high blood pressure, blood sugar imbalances and excess blood lipid levels. And the reverse is also true: Losing weight, especially abdominal fat, is the first step in lowering blood pressure and getting blood cholesterol levels under control.”

Michos notes that other research has shown a loss of just five pounds lowers people’s risk of pre-diabetes by 31 percent. Losing 10 pounds lowers blood pressure by 5 millimeters of mercury.

Michos says she has started her campaign with local physicians because it will take a few years to amass the necessary additional evidence to change national clinical guidelines. Results from the 2007 screenings, coordinated by the Maryland-based Sister to Sister, Everyone Has a Heart Foundation, will not be ready until later this year.

“Physicians and others have unfortunately become too accustomed to seeing heavy- set people, and there is a risk that we overlook or dismiss being overweight and obesity as a potential and future source of heart problems,” says Michos. “Even if the problems are not evident now, it is more important to start screening women at a younger age to forego heart problems later in life.

“Community screening events have confirmed that many women are unaware of their risk factors and the screenings have proven effective at identifying those women at risk and, hopefully, we will be able to expand these programs in the future,” she adds, noting that 48 percent of women with high cholesterol levels were newly diagnosed with the condition, as were 7 percent of women with hypertension. “Awareness is the first step to implementing heart-healthy lifestyle changes to reduce their risk,” says Michos. The next Sister to Sister community screening event will take place in February 2009.

Furthermore, Michos says annual survey results, though specific to women, also bear significance for men, for whom a waistline greater than 40 inches is considered obese.
Researchers say their next steps are to monitor screened women to see how well follow-up treatments worked at not only lowering risk, but also in lowering actual heart problems and whether or not this stretches out lifespan.

Of 150 women who were screened as high risk in 2006, 71 percent followed up with a visit to their physician, 64 percent changed diet, 47 percent lost weight, 61 percent monitored their blood pressure levels, 6 percent stopped smoking, and 23 percent checked their waistline against the 35-inch benchmark.

According to the latest statistics from the American Heart Association, one in three American women has some form of cardiovascular disease. Sixty-nine million women are overweight, including more than 36 million who are obese.

Funding for this study was provided by the Sister to Sister, Everyone Has a Heart Foundation. Besides Michos, other researchers from the Johns Hopkins Ciccarone Preventive Cardiology Center involved in this study and the Sister to Sister annual screenings were Brian Kral, M.D., M.P.H.; Catherine Campbell, M.D.; M. Dominique Ashen, Ph.D., C.R.N.P.; and Roger Blumenthal, M.D. Other researchers included Irene Pollin, Ph.D., M.S.W., and Laurene McKillop, Ph.D., from Sister to Sister; Teresa Shattuck, Ph.D., Michele Debarthe Sadler, Ph.D., and Karen Boyle, Ph.D., from Shattuck & Assoc.; Khurram Nasir, M.D., M.P.H., from Massachusetts General Hospital in Boston; Rita Redberg, M.D., from the University of California San Francisco; and Karlynn Brintzenhofeszoc, Ph.D., M.S.W., from Catholic University of America in Washington, D.C.

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Mayo Clinic Study Reveals Rural, Unmarried Women at Higher Risk for Depression

mdash; Mayo Clinic research suggests unmarried women living in rural areas have lower self-rated health status than their married counterparts. This lower health status often includes greater instances of self-assessed feelings of depression. The results of the study were recently published in the Journal of Evaluation in Clinical Practice. They suggest that primary care physicians should take a proactive role in addressing health concerns of single women.

"We tend to focus on disease, but as the World Health Organization notes, good health includes physical, mental and social well-being and not merely the absence of disease," says James Rohrer, Ph.D., of Mayo Clinic's Department of Family Medicine and lead author of the study. "Being single may be associated with a greater degree of separation from usual health care, as many women gain insurance through a spouse or a former spouse. Lack of social support also may contribute to poor health among some single women."

Researchers used a cross-functional survey to gather self-ratings of overall health among female primary care patients aged 18 years and older who live in cities with a census of approximately 3,000. The study analyzed marital status and self-assessed mental health as potential risk factors for poor overall self-rated health among female primary care patients. The analysis revealed that single or divorced women are more prone to poor self-rated health compared to married women. Women who described themselves as being depressed also had worse overall health. Women aged 65 and older had an even higher risk of poor self-
rated health.

While the data were finalized in 2000, Dr. Rohrer notes that current economic concerns may exacerbate the risk.

"Economic problems increase feelings of emotional stress. People today are worried about, among other things, the mortgage crisis and high gas prices. Many are left wondering how they are going to pay for necessities. Statistically, rural, unmarried women are more often economically depressed than their married counterparts," says Dr. Rohrer. "If the economy worsens, we will see a significant impact on visits to primary care physicians and nurses. Medical providers are trained to focus on the biological and psychological. But economic causes of poor health? I don't think that receives a lot of air time in medical school."

Patients experiencing feelings of poor self-rated mental health can address these concerns with screening, health promotion and treatment programs. Screening can be followed-up with self-help materials, support groups and medication if deemed appropriate by the physician. Referrals to financial counseling might have indirect therapeutic value.

Other study authors are Matthew Bernard, M.D., Department of Family Medicine; Norman Rasmussen, psychologist, Departments of Family Medicine and Psychiatry and Psychology; Halina Woroncow, M.D., Kasson Clinic, Department of Family Medicine, all of Mayo Clinic Rochester; and Yan Zhang, Ph.D., Department of Family Medicine, Texas Tech University Health Sciences Center.

PIEDMONT HOSPITAL URGES GEORGIA WOMEN TO GET SCREENED

In 2007, the American Cancer Society estimated there were 11,000 cases of cervical cancer diagnosed in the United States. While cervical cancer is at a four percent decrease overall, thousands of women are still dying as a result of it each year. January is Cervical Cancer Awareness and Screening Month and Piedmont Hospital is encouraging women throughout Georgia to get cervical cancer screenings.

The primary reason for the decline in the incidence and mortality rate of women with cervical cancer is due to the widespread use of the Papanicolaou (Pap) test to detect cervical abnormalities. A Pap test can detect cervical cancer before it spreads or even develops – dramatically improving the odds of surviving the disease, and it is the most important thing women can do to protect themselves from cervical cancer.

“Regular screenings for women are the first defense against cervical cancer,” said Alfred Jenkins, M.D., OBGYN at Piedmont Gynecology Oncology. "If more women were screened regularly, many unnecessary deaths from cervical cancer could be avoided."

The American Cancer Society recommends two ways to prevent cancer: Avoid the risk factors for pre-cancers, such as HPV, and get a regular Pap test. The Pap test can even detect HPV infection and pre-cancers. Treatment of these problems can stop cervical cancer before it develops fully into an invasive cancer.

“Since January is Cervical Cancer Awareness and Screening Month, it is the perfect time to encourage women to see their doctor to get screened for cervical cancer,” Dr. Jenkins said. “I also encourage them to ask their doctor about the HPV vaccine as another method to prevent cervical cancer.”

Dr. Jenkins has been a part of the Piedmont Healthcare family since early last year, working with Piedmont Gynecologic Oncology located on the Piedmont Hospital campus. He also holds part-time office hours at Piedmont Fayette Hospital in Fayetteville. Dr. Jenkins is board-certified in obstetrics and gynecology and gynecologic oncology. Prior to joining Piedmont Gynecologic Oncology, Dr. Jenkins served as director of the Division of Gynecologic Oncology at M.D. Anderson Cancer Center-Orlando. While there, he performed the first gynecologic robotics procedure in the state of Florida. He also performs fertility-sparing surgery for cervical cancer.