/24-7PressRelease/- Researchers have expressed concern over a new campaign initiated by the tanning industry, which seeks to dispel the link between melanoma, the most serious form of skin cancer, and UV exposure from natural or artificial sources (such as tanning beds). In response, nearly 500 of the foremost experts on melanoma signed a statement affirming the existence of evidence-based data demonstrating the harmful effects of UVA and UVB radiation. The statement, which was initiated at the 5th Melanoma Research Congress in Sapporo, Japan on May 7-12, not only states that UV rays increase one's risk for skin cancer, including melanoma, but also maintains that the use of indoor tanning (outside of medical practice) represents an example of an avoidable cause of lethal cancer.
Studies show that UV light is a carcinogen (i.e. causes cancer). This occurs when skin cells are damaged after UV exposure (either from the sun or a tanning bed). The same DNA damage that triggers tanning also appears capable of causing cancerous mutations in skin cells. If those mutations are not completely repaired—as frequently occurs—skin cancers may result. Additional data demonstrates that indoor tanning devices emit UV radiation that is similar to, and sometimes more powerful than, that emitted by the sun. In fact, a systematic review of worldwide data, published in the March 2007 issue of the International Journal of Cancer, found a prominent, consistent increase - 75 percent - in risk for melanoma in people who begin using tanning beds in their teens or twenties. Additionally, the review also showed that people across all age groups who have ever used tanning beds face a 15 percent higher risk of developing melanoma than those who have not. Even more dramatic increases were seen in certain non-melanoma forms of skin cancer, such as squamous cell carcinoma, a tumor that only on occasion spreads from the skin and may then be lethal.
Many scientists also point out that vitamin D, although produced in the skin, can easily be obtained by non-UV related means, such as dietary supplements. These dietary supplements would not carry the risk of cancer associated with UV radiation, in cases where increased vitamin D levels are deemed beneficial.
The Melanoma Research Foundation's (MRF) Scientific Advisory Committee stated, "The petition was developed to reinforce that the scientific community continues to stand behind strong data supporting the connection between skin cancer and UV-exposure. As physicians and scientists, we are concerned that this campaign may confuse the public, putting them at an increased risk for a disease that is too often lethal."
Melanoma is one of the fastest growing cancers in the U.S. and can strike people of all ages, all races and both sexes. In fact, one in 50 people have a lifetime risk of developing melanoma. Further, approximately 65 percent of all melanomas are attributed to UV exposure resulting from natural and artificial sources.
A wealth of information exists about how to reduce the risk of developing melanoma and other skin cancers, yet both MRF and SMR advise that the most important measure the public can take is to avoid intentional sunbathing and indoor tanning devices. For those who want to learn safe ways to access to vitamin D and look "tan," or for more information about melanoma and UV exposure, please visit http://www.melanoma.org or http://www.societymelanomaresearch.org.
Saturday, May 31, 2008
/24-7PressRelease/- Researchers have expressed concern over a new campaign initiated by the tanning industry, which seeks to dispel the link between melanoma, the most serious form of skin cancer, and UV exposure from natural or artificial sources (such as tanning beds). In response, nearly 500 of the foremost experts on melanoma signed a statement affirming the existence of evidence-based data demonstrating the harmful effects of UVA and UVB radiation. The statement, which was initiated at the 5th Melanoma Research Congress in Sapporo, Japan on May 7-12, not only states that UV rays increase one's risk for skin cancer, including melanoma, but also maintains that the use of indoor tanning (outside of medical practice) represents an example of an avoidable cause of lethal cancer.
Blue Cross and Blue Shield of Georgia (BCBSGa) has named the Emory University's Winship Cancer Institute of Emory University as a Blue Distinction Center for Complex and Rare Cancers, focusing on complex inpatient and surgical care. Emory Winship is the only facility in the metropolitan Atlanta area to earn this designation.
Blue Distinction is awarded by Blue Cross and Blue Shield companies to medical facilities that have demonstrated expertise in delivering quality healthcare. Building on the successful results of earlier programs focused on cardiac care, bariatric surgery and transplants, the program was recently expanded to include the designation of 85 Blue Distinction Centers for Complex and Rare Cancers.
"We are honored to be recognized as a Blue Distinction Center by Blue Cross and Blue Shield," says Charles Staley, MD, director of surgical oncology at Emory Winship and Holland M. Ware Professor of Surgery, Emory University School of Medicine. "This designation is a confirmation of the hard work and dedication to research and patient care that is exhibited every day by our faculty, nursing and administrative staff. We are very proud of this designation."
Blue Cross and Blue Shield assesses facilities on evaluation, treatment planning, complex inpatient care and major surgical treatments; all delivered by teams with distinguished expertise and subspecialty training for complex and rare cancers. The program focuses on the following 13 cancers, which cumulatively account for approximately 15 percent of new cancer cases annually:
• acute leukemia (inpatient, non-surgical)
• bladder cancer
• bone cancer
• brain cancer -- primary
• esophageal cancer
• gastric cancer
• head and neck cancers
• liver cancer
• ocular melanoma
• pancreatic cancer
• rectal cancer
• soft tissue sarcomas
• thyroid cancer -- medullary or anaplastic
The evidence-based selection criteria used to evaluate facilities were developed in strategic collaboration with the National Comprehensive Cancer Network and with input from a panel of expert clinicians. To be designated as a Blue Distinction Center for Complex and Rare Cancers, Emory Winship met selection criteria including:
• exceeds volume threshold for annual surgical cases treated
• utilization of multidisciplinary team input for treatment planning, including sub-specialty trained teams
• participation in ongoing quality management and improvement programs for cancer care
• commitment to using clinical data registries and participating in relevant clinical research
"We commend the facilities that have been designated for treating complex and rare cancers," says Monye Connolly, president, BCBSGa. "Blue Distinction promotes the consistent practice of evidence-based medicine. The Blues are committed to working collaboratively with physicians and hospitals to raise the overall quality of healthcare in our nation. We understand that to deliver true patient-centered care, Blue Distinction Centers often need to coordinate care following a complex surgery or primary inpatient stay with patients' local physicians."
BCBSGa recognizes that the majority of patients' multidisciplinary treatment may be best accomplished by integrating the expertise available in a Blue Distinction Center with locally available treatment resources, especially for outpatient chemotherapy and radiotherapy, based on individual circumstances and patient preference. Optimal support of a patient's comprehensive cancer care needs may be achieved by coordination of care between the patient and their family, local physicians, the Blue Distinction Center and BCBSGa. For more information on additional criteria used for the designation visit www.BCBS.com.
For more information about complex and rare cancer care at Emory Winship call 404-778-1900 or visit www.cancer.emory.edu or www.emoryhealthcare.org. For more information about Blue Distinction Centers, visit www.BCBSGa.com.
Friday, May 30, 2008
The U.S. Food and Drug Administration today issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008.
CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.
Three HFA-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.
"Concern about the environment stimulated the need to phase out CFCs," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers."
Albuterol inhalers are used to treat bronchospasm (wheezing) in patients with asthma and chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. Patients use albuterol inhalers to deliver medicine directly into the lungs.
The FDA is urging patients to talk with their health care professionals now about switching to HFA-propelled albuterol inhalers. These products are safe and effective replacements for CFC-propelled albuterol inhalers.
Manufacturers have been increasing production of HFA albuterol inhalers, so an adequate supply is available now.
HFA-propelled albuterol inhalers may taste and feel different than the CFC-propelled albuterol inhalers. The spray of an HFA-propelled albuterol inhaler may feel softer than that of a CFC-propelled albuterol inhaler. Patients must also prime and clean HFA-propelled albuterol inhalers. Doing so prevents buildup of the drug in the inhalation device, and buildup can block the medicine from reaching the lungs. Each HFA-propelled albuterol inhaler has different priming, cleaning, and drying instructions, and patients should read and understand the instructions first before using the inhaler.
The phaseout of CFC-propelled inhalers is the result of the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the United States has agreed to phase out production and importation of ozone depleting substances including CFCs. No CFC-propelled albuterol inhalers may be produced, marketed or sold in the United States after Dec. 31, 2008.
BUSINESS WIRE--A new study from the University of Alabama at Birmingham indicates that the OtisKnee Custom Fit Knee™ Replacement system may have a positive impact on length of hospital stay, range of motion, pain level and patient satisfaction immediately following total knee replacement surgery. The study abstract, titled “MRI-Guided Custom-Fit Total Knee Replacement: The First Six Weeks,” was presented at the joint Alabama Orthopedic Society and Mississippi Orthopedic Society annual meeting on May 3, 2008 in Sandestin, Fla. by Herrick Siegel, M.D., associate professor of surgery at the University of Alabama at Birmingham and lead investigator of the study.
Designed to evaluate the impact of OtisKnee on the early success of total knee replacement, the study involved 25 total knee replacements performed in 19 patients using the custom-fit OtisKnee technology. Each patient was followed for six weeks, a crucial period for predicting ultimate satisfaction with the procedure. Results showed that OtisKnee had a positive influence on length of hospital stay, range of motion, pain and patient satisfaction, as seen by the following data.
In addition, the study results indicated that OtisKnee is useful to the surgeon in pre-determining ideal implant size as well as defining proper rotation and positioning during the total knee replacement procedure.
“While total knee replacement has been a successful surgery historically, studies have shown that nearly 14 percent of patients have reported being dissatisfied or very dissatisfied with their surgery,” said Dr. Siegel. “Preliminary results with OtisKnee indicate that this unique, custom-fit approach may lead to a more predictable, reproducible and optimal result for patients.”
Since its limited U.S. launch in June of 2007, the OtisKnee technique has been performed by more than 400 surgeons on more than 7,000 patients. Initial clinical data demonstrating the value of OtisKnee in total knee replacement has been presented at the American Academy of Orthopaedic Surgeons annual meeting and has been accepted for publication in a peer-reviewed orthopedic trade journal.
BUSINESS WIRE--Participants in a Federal Drug Administration (FDA) protocol at TCA Cellular Therapy utilizing stem cells to treat lower limb ischemia are experiencing increased mobility and decreased pain in lower legs.
Lower limb ischemia is a condition where plaque build-up causes decreased circulation in the lower leg. Symptoms of the condition include intense pain and swelling.
Study participants may have had different factors that contributed to their condition: a family history of Peripheral Artery Disease (PAD), history of smoking and other vascular conditions. Common among them however, were that more traditional treatments (utilizing stents and grafts) were ineffectual and that the patients were losing their ability to continue their daily activities.
Meryl Sharp was an avid gardener before she had to give up the hobby last year. She could no longer walk the length of the lawn without stopping to rest her throbbing legs. “It got to the point where the intervals of rest were not even enough to ease the pain,” she said.
The study participants were referred by their vascular surgeons to TCA Cellular Therapy, where Gabriel Lasala, M.D. and Jose Minguell, Ph.D. have been authorized by the FDA to study the safety and efficacy of stem cell therapy for lower limb ischemia.
“The similarity in the recovery of our patients is promising,” said Dr. Lasala. “We find that the stem cells, once re-injected, go about forming new blood vessels, thus increasing circulation dramatically.”
Drs. Lasala and Minguell have developed a treatment where a patient’s own stem cells are taken from the hip, grown in a sterile environment and then re-infused into 38 areas of the leg.
So far, ten patients have received the stem cell treatment for peripheral vascular disease.
“Patients are experiencing increased mobility within weeks of their infusions. The continued improvement throughout their recoveries is a positive sign,” Lasala said.
Carleton Wert could only walk 2 ½ minutes on the treadmill before he underwent the stem cell therapy. At his three week check-up, he clocked 4 minutes. Within two months, his time improved to over 10 minutes.
Similarly, Michael Pearl could not even undergo the treadmill test prior to his infusion in mid-November because his pain was so intense. He went from walking 5 minutes at his one-month check-up to 18 minutes at the three-month mark.
With increased mobility, Dr. Lasala’s patients are resuming their normal routines. Wert, who was on disability because of the ischemia, is now seeking employment. Sharp has gone back to gardening, creating a new antique garden with her husband in their front yard.
Perhaps most striking is the transformation experienced by Penny Kibideaux. Running out of options to treat her ischemia, Kibideaux had already scheduled a leg amputation. Under the advice of her physician, Kibideaux went to see Dr. Lasala. Not only has he saved her leg, Kibideaux says he has saved her life. Just weeks after her November infusion, she walked several shopping malls as part of her Christmas shopping. She has also recently taken up line dancing.
The FDA protocol study will continue for the next two years, after which Dr. Lasala expects that stem cell treatment for lower limb ischemia will be widely utilized in the medical community.
“We are excited that our patients are responding well to the treatment,” he said. “We hope that more people will be able to experience relief and improve their quality of life through this procedure.”
Falls A Leading Cause Of Injury-Related Emergency Department Visits For Infants Each Year, CDC Study Shows
Half of the estimated 328,500 infants 12 months of age or younger who were treated for injuries in hospital emergency departments each year from 2001 to 2004 were injured as a result of a fall, according to a study by the Centers for Disease Control and Prevention. The first national estimate of infant injury by month of age was published in the May 2008 American Academy of Pediatrics journal, Pediatrics.
Falls were the leading cause of injury for every month during the first year of life. Because the first year of a baby’s life is a time of rapid developmental change, every month brings different injury risks as mobility develops. CDC researchers indicate that each stage of infant development, such as whether a child is crawling or walking, plays a large role in types of injuries.
"Common sense tells us, and research confirms, that injuries among infants take a significant toll," said Ileana Arias, Ph.D., director of CDC′s Injury Center. "As children develop -- in infancy and throughout childhood -- protective factors such as home safety measures and close parental supervision are critical in helping to prevent injuries."
A crucial factor is the child’s developing mobility. Stair-related injuries are an example, leading to treatment for an estimated 5,500 12-month-olds but only 800 1-month-olds.
"When parents are aware of first-year motor milestones and their associated injury risks, they can be better prepared to help predict and prevent their infants from being injured," said Julie Gilchrist, M.D., an author on the study and medical epidemiologist in CDC’s Injury Center.
The findings came from an analysis of data collected from the Consumer Product Safety Commission’s national database on injuries seen in hospital emergency departments
For more information about CDC’s prevention efforts, please link to www.cdc.gov/injury. For a copy of this study, please link to http://pediatrics.aappublications.org/.
Tiffany Hudak wears the crown because she is Mrs. Georgia 2008. She wears the bracelet on her wrist because she wants to bring awareness to lung cancer.
Five years ago, Hudak’s mother was diagnosed with lung cancer at a routine doctor’s visit. She died three weeks later.
“There is no way to detect lung cancer early,” she said. “Once it is found, it is too late.”
Lung cancer doesn’t only affect smokers. More than 21,000 people die each year from lung cancer caused by radon. Georgia has the highest rate in the Southeast with 822 deaths last year.
Radon is a cancer-causing radioactive gas that comes from the natural breakdown of uranium in soil, rock and water. It is invisible, odorless and tasteless. Regions with a lot of granite have a higher risk for radon.
According to the Environmental Protection Agency, all north Georgia counties have a moderate to high potential for radon. Cobb, Fulton, DeKalb and Gwinnett counties have the highest potential for it.
Raised in Elberton, Ga., known as the granite capitol of the world, radon awareness is important to Hudak.
“It is scary. It is all around us,” she said.
Since winning her crown in February 2008, she has thrust the spotlight on her cause. She has been featured in several newspaper articles and will be on the cover of Athena magazine later this year. She hosted the Georgia “Free to Breath” 5k run in April, which raised more than $5,000 for the National Lung Cancer Partnership. And she’s joined forces with the University of Georgia Cooperative Extension.
“Radon is truly a silent killer,” said Becky Chenhall, a UGA Extension radon educator. “It is so easy to ignore because you can’t see, smell or taste it. The only way to know the radon level in your home is to test for it.”
UGA Extension offices distribute free radon test kits. Since the program started five years ago, 22,000 test kits have been distributed.
“We are saving lives by educating and motivating people to take action,” Chenhall said. “The bad news is radon causes lung cancer. The good news is that any radon problem can be fixed.”
Radon is heavier than air. Test kits should be hanged two feet to six feet above the floor in the center of a room. Bedrooms or family rooms are the best rooms to test. Children are at greater risk of radon exposure. The radon level at a child’s breathing level is higher than that found at an adult’s.
Radon test results will never be 0. The average indoor level is 1.3 pCi/L. Any test that measures 4 pCi/L or higher requires action. Nationally, one out of every 15 homes will have high radon. In north Georgia, one out of every five homes could have elevated radon.
When required, mitigation can be done relatively cheap. The gas can be safely released from the home by installing an inline fan and running a ventilation pipe from underneath the home’s foundation to above the roofline. Georgia currently has 10 certified radon mitigators trained to correct radon problems.
by April Sorrow
University of Georgia
April R. Sorrow is a news editor with the University of Georgia College of Agricultural and Environmental Sciences.
Thursday, May 29, 2008
Researchers at Duke University Medical Center have uncovered definitive evidence that a small but potent subset of immune system B cells is able to regulate inflammation.
Using a new set of scientific tools to identify and count these cells, the team showed that these B cells can block contact hypersensitivity, the type of skin reactions that many people have when they brush against poison ivy.
The findings may have large implications for scientists and physicians who develop vaccines and study immune-linked diseases, including cancer. Once the cells that regulate inflammatory responses are identified, scientists may have a better way to develop treatments for many diseases, particularly autoimmune diseases such as arthritis, type 1 diabetes and multiple sclerosis.
"While the study of regulatory T cells is a hot area with obvious clinical applications, everyone has been pretty skeptical about whether regulatory B cells exist," said Thomas F. Tedder, Ph.D., chairman of the Immunology Department and lead author of the study published in the May 16 issue of Immunity. "I am converted. They do exist."
Koichi Yanaba and Jean-David Bouaziz identified this unique subset of small white blood cells, which they call B10 cells, in the Tedder laboratory.
The researchers found that B10 cells produce a potent cytokine, called IL-10 (interleukin-10), a protein that can inhibit immune responses. The B10 cells also can affect the function of T cells, which are immune system cells that generally boost immune responses by producing cytokines. T cells also attack tumors and virus-infected cells.
The study was supported by grants from the NIH, the Association pour la Recherche contre le Cancer (ARC), Foundation Rene Touraine, and the Philippe Foundation.
Depleting B10 cells may enhance some immune responses, Tedder said. Enhancing B10 cell function may inhibit inflammation and immune responses in other diseases, like contact hypersensitivity.
"Now that we have been able to identify this regulatory B cell subset, we have already developed treatments that deplete these cells in mice. We are moving to translate these findings to benefit people," he said.
"The discovery of the ability to identify this potent regulatory cell type should provide important clues to how the immune system regulates itself in response to vaccines as well as infectious agents," says Barton F. Haynes, M.D., leader of the international Center for HIV/AIDS Vaccine Immunology (CHAVI), a consortium of universities and academic medical centers, and director of the Duke Human Vaccine Institute. "This information should enable researchers to design ways to help the immune system control infections more effectively, and could be a useful advance as we refine approaches to preventing HIV infection."
There's a huge initiative underway to look at regulatory T cells in autoimmune disease, HIV infection, and cancer therapy," Tedder said. "What we have also shown is that it is not only regulatory T cells, but also regulatory B cells that could prevent a person from making effective immune responses in HIV and many other diseases, particularly cancer."
The Duke researchers developed a way to mark the B10 cells so that they could see that just these cells were producing IL-10. Previously, scientists could only purify a population of B cells and see whether IL-10 could be produced by some of these cells in the population.
In this study, they found that the B10 cells represented only 1-2 percent of all of the B cells in the spleen of a normal mouse. Before this, no one had definitively identified this B cell subset or such regulatory B cells in normal mice, although B cell regulatory function had been described in some genetically altered mice with chronic inflammation.
"In this study, we could directly look at the B cells that were producing IL-10, and figure out what their cell surface molecules looked like, so that we could isolate them. This allowed us to show that this rare subset of B cells controlled immune responses by producing IL-10, which inhibits T cell inflammatory responses," Tedder said.
The scientists studied a special mouse (CD19-deficient) with altered genes that give them an increased contact hypersensitivity reaction. As it turned out, these mice lacked B10 cells, which resulted in exaggerated inflammation reaction. "This allowed us to show that giving CD19-deficient mice a few B10 cells had a big effect on reducing inflammation," Tedder said.
They found that depleting all B cells in the mice also resulted in worse inflammation. Since total B cell depletion therapies are now being used to treat people with B cell cancers and autoimmune disease, these findings help to further explain how these therapies treat disease. They also open the door to creating new therapies that take advantage of the power of B10 cells.
This is the first of several papers that will describe cases in which regulatory B10 cells help control immune responses, Tedder said.
Karen Haas and Jonathan Poe of the Duke Department of Immunology, and Manabu Fujimoto of the Department of Dermatology at Kanazawa University Graduate School of Medical Science in Ishikawa, Japan, were the paper's other authors.
Johns Hopkins undergraduates have designed and built a device to enable critically ill intensive care unit patients to leave their beds and walk while remaining tethered to essential life-support equipment. The invention allows doctors to better understand whether carefully supervised rehabilitation, as opposed to continuous sedation and bed rest, can improve the recovery of intensive care patients.
Some clinicians believe that allowing ICU patients to get out of bed and walk could avert some of the muscle weakness, bedsores and depression that typically develop when these patients are kept heavily sedated and confined to bed. Because such patients usually must remain connected to an artificial breathing machine, heart monitors and intravenous lines with essential medications, a simple walk down the hall can require four staff members to accompany the patient.
To reduce this staffing demand and improve this new ICU rehabilitation program, a physician at Johns Hopkins Hospital last year asked students in a biomedical engineering design team course to devise a mobility aid for ICU patients. Over two semesters, the students, supervised by faculty members and graduate students and advised by hospital staff, produced a device called the ICU MOVER Aid. This device has two components: a novel mobility aid that combines the rehabilitative features of a walker and the safety features of a wheelchair, and a separate wheeled tower to which important life-support equipment can be attached.
"The finished product is truly outstanding," said physician Dale Needham, an assistant professor in the Division of Pulmonary and Critical Care Medicine at the Johns Hopkins School of Medicine. "The most recent version of the MOVER is far beyond a rough prototype. The students exceeded everyone's expectations in designing a device that we could routinely use in the Medical ICU."
To help him improve the new Medical ICU rehabilitation program at Johns Hopkins, Needham had challenged the students to produce a device that would meet three key criteria. First, it had to provide physical support for the patient during walking. Second, it had to safely house all necessary monitoring and therapeutic equipment for critically ill patients. Finally, it needed a safety backup system for patients who must immediately sit down because of fatigue or a sudden change in their medical condition.
"We ended up building three versions," said Joshua Lerman, a senior biomedical engineering student who served as team leader. "First, we used PVC pipes to work on the basic design. Then, we made an aluminum version. We made the final prototype mostly of steel. All through the process we got feedback from the hospital's ICU staff, who told us what we needed to change to make it better suit patients' needs. All of the staff involved in the ICU rehabilitation program were very happy with the final version."
This final version features a walker type framework, similar to devices that some frail or elderly people use to get around. Immediately behind the patient, however, a fabric seat is attached to the frame so that a tired patient can sit down. The seat can also "catch" a patient who abruptly collapses because of a medical problem. "We made the seat out of ballistic nylon because we didn't want it to rip," said Lerman, 22, from Delray Beach, Fla. "It's durable, and it's easy to clean for infection-control purposes."
As a separate component, the prototype features a tower designed to accommodate two oxygen tanks and three medical devices: a cardiac monitor, intravenous infusion pumps to provide medications, and a ventilator to support breathing. Despite all of the equipment attached to it, the MOVER prototype was small enough to maneuver through the Medical ICU's narrow hallways, although using it in the ICU patient rooms, which are particularly small, proved to be more challenging. In terms of improved efficiency, the inventors said, the MOVER requires only two hospital staff members to accompany the walking patient, compared with four staff under the earlier system.
Needham, the project's faculty sponsor, said, "We've tried this device on one MICU patient so far, and we are certainly keen to continue using it as part of our physical medicine and rehabilitation program in the Medical ICU at Johns Hopkins. The MOVER worked as well with the real patient as it did when we tested it with the biomedical engineering students serving as simulated patients."
At a recent competition for Johns Hopkins biomedical engineering design projects, the MOVER's team took second-place honors. The student inventors and their faculty mentors have obtained a provisional patent for the device and are exploring commercialization opportunities. Needham said much will depend on how quickly other hospitals adopt new therapies in the ICU setting to improve patient recovery. "With the increasing interest in early mobility for ICU patients and the emerging scientific evidence supporting the benefit of this approach," he said, "I think there is a strong commercial future for the MOVER device."
In addition to Lerman, the undergraduates who worked on this project were Ravy Vajravelu, Derrick Kuan, Jeremy Elser, Erica Jantho, Jinjie Chen, Hanlin Wan and Swarnali Sengupta. The design course is taught by Robert Allen, an associate research professor and senior lecturer in the Department of Biomedical Engineering.
Wednesday, May 28, 2008
FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.
Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.
"With this proposal, FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit," said Rear Admiral Sandra Kweder, M.D., Center for Drug Evaluation and Research, FDA. "This proposal would help make drug labeling a better communication tool, and would potentially have a huge impact on public health and well being for women."
There are about six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Additionally, women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy.
The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.
In the 1990s, the FDA recognized the shortcomings of pregnancy and breastfeeding information in prescription drug labeling and began reviewing ways to improve the information. The agency held public meetings and focus groups to obtain comment on the current labeling from health care professionals and scientific experts. Current labeling uses a letter category system to describe the risks of drug use during pregnancy. Stakeholders have said the letter category system leads to an inaccurate and overly simplified view of these risks, and does not facilitate updating of labeling as new information becomes available.
The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:
The first section, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: "Human data indicate that (name of drug) increases the risk of cardiac abnormalities." This would be followed by a summary of the most important data on the drug’s effects.
Another section, called "Clinical Considerations," would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.
The third section, under the heading "Data," would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.
The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.
The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.
Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA’s recent Physician Labeling Rulemaking.
Electronic comments can be submitted within 90 days via the Federal Documents Management System/eRulemaking portal at www.regulations.gov. The FDA will carefully consider the comments in preparing a final rule.
mdash - A new medication appears to offer significant relief to patients with severe chronic constipation while minimizing the likelihood of cardiac-related side effects, according to results of a study published this week in the New England Journal of Medicine.
The trial involved 38 medical centers and was led by Michael Camilleri, M.D., a Mayo Clinic gastroenterologist. Patients who met the study criteria were randomly assigned to receive either of two dosage levels of prucalopride, a medication that stimulates protein receptors involved in contraction of the colon, or a placebo.
"Many more of the patients taking prucalopride were able to have spontaneous bowel movements without having enemas or taking laxatives, as compared to those who were given placebo," says Dr. Camilleri. "The time it took to have a first bowel movement was much shorter, and quality of life and other abdominal symptoms also were improved for those taking the study drug."
Constipation is a common medical problem, affecting about 15 percent of Americans who spend several billion dollars each year on laxatives and other treatments. Prevalence is higher among women and African-Americans and is particularly increased in the elderly. This study involved patients with an extreme but common version of constipation called severe chronic constipation.
To participate, patients had to have at least six months of constipation, defined as an average of fewer than three bowel movements a week. Those who had more than four bowel movements during the two-week "run-in" period before treatment began were not eligible.
"The normal range of bowel movements is anywhere from three per day to three per week," explains Dr. Camilleri. "The 620 patients studied in this trial were severely constipated, averaging only one bowel movement during the two weeks before entering treatment, and most had struggled with the problem for several years, not merely months."
The 2 milligram (mg) and 4 mg doses of prucalopride appeared roughly equal in benefit, with about 30 percent of patients averaging three bowel movements per week during the 12-week study. Only 12 percent of patients on placebo averaged three bowel movements per week. Nearly half (47.3 and 46.6 percent, respectively) of the patients taking prucalopride increased their bowel movements by at least one per week, while about a quarter (25.8 percent) of those on placebo had a similar improvement.
The most common adverse effect from the drug was diarrhea, which tended to occur in the early stages of treatment, but most patients later settled into a more normal routine of bowel movements. Increased bowel movements and diarrhea are expected effects of the drug. Only 1.5 percent and 4.4 percent of patients treated with 2 mg and 4 mg of prucalopride, respectively, stopped the drug due to diarrhea. "This suggests that the diarrhea was less bothersome than the constipation had been," Dr. Camilleri says. Headaches were a less frequent side effect.
Dr. Camilleri says the cardiac risk issues that have been raised about related drugs for constipation including tegaserod, appear to be less of a concern for prucalopride. "Prucalopride is highly selective in its effect, and doesn't interact significantly with other protein receptors, such as those involved in regulating heart rhythm," he explains. "We conducted electrocardiogram testing during the study and did not find heart rhythm issues, although two of the three patients who withdrew from the study did have symptoms, palpitations and dizziness that may have been attributable to an effect on the cardiovascular system."
Prucalopride is not yet approved for use in the United States or in any other country.
Dr. Camilleri says results from other studies will need to be compiled and published, and safety
and efficacy data submitted to the Food and Drug Administration for review, before it can be approved in the United States as a treatment for chronic constipation.
Ed Lovern Appointed Executive Vice President and Chief Administrative Officer for Piedmont Healthcare
Ed Lovern has been named executive vice president and chief administrative officer of Piedmont Healthcare, effective July 1, 2008. R. Timothy Stack, president and CEO of Piedmont Healthcare, made the announcement.
Lovern has served as president and CEO of Piedmont Mountainside Hospital since August 2004. Previously, he was executive vice president of Corporate Services for Piedmont Healthcare. He joined Piedmont in 2002 and worked on a variety of key growth initiatives. Over the past four years, he has guided Piedmont Mountainside Hospital as it has doubled patient volumes, completed a major expansion, and won prestigious awards, such as the Georgia Alliance of Community Hospitals’ Small Hospital of the Year designation in 2006. Piedmont Mountainside Hospital also received national recognition for improvements in patient satisfaction and technological advancements during Lovern's tenure.
“Ed is an extraordinary leader and has a unique ability to get things done,” said Stack. “In his tenure at Piedmont Mountainside, he has helped Piedmont establish a footprint of world-class healthcare for the Pickens County community. We now call on his expertise to guide several key strategic business components of Piedmont Healthcare for the benefit of all those we serve.”
Lovern said, “The last four years have been among the most exciting and rewarding of my career. I have been privileged and honored to work with the employees, physicians and volunteers and with this wonderful community.” Lovern was named CEO of the Year by the Georgia Alliance of Community Hospitals in 2006.
An interim president and CEO for Piedmont Mountainside Hospital, effective July 1, 2008, will be named in the near future.
Before coming to Piedmont in 2002, Lovern was the Washington, D.C., bureau chief for Modern Healthcare, a weekly healthcare business magazine. He also served in various executive roles at Borgess Health Alliance, a five-hospital regional healthcare system in Kalamazoo, Mich.
A native of Lynchburg, Va., Lovern holds a bachelor of arts degree from Randolph-Macon College in Ashland, Va., and a masters in health administration from Virginia Commonwealth University. He and his wife, Ginny, have two children and currently reside in Marietta.
Sunday, May 25, 2008
Mayo Clinic Researchers find Adding Epratuzumab to Standard Therapy for Aggressive Lymphoma Produces Significant Overall Response
mdash - Adding a second monoclonal antibody drug to chemotherapy looks promising for treatment of diffuse large B-cell lymphoma, according to Mayo Clinic researchers working with the North Central Cancer Treatment Group (NCCTG) (http://ncctg.mayo.edu/). Results of this interim analysis were released May 15 as part of the 44th Annual Meeting of the American Society of Clinical Oncology.
Researchers found that 95 percent of patients responded to treatment that included the drug epratuzumab with the standard "R-CHOP" therapy. R-CHOP combines three chemotherapy drugs (cyclophosphamide, doxorubicin and vincristine) with the steroid drug prednisone and rituximab, a monoclonal antibody. Final results will be reported next year.
Diffuse large B-cell lymphoma is one of the most common and aggressive forms of non-Hodgkin lymphoma (NHL), a cancer of the white blood cells known as B-lymphocytes.
In 78 patients, researchers found:
95 percent of participants (75 patients) improved as a result of the treatment.
63 percent of participants (47 patients) were disease free.
Researchers also were able to look at the primary endpoint of the study — disease-free survival at 12 months — in 34 patients. Eighty five percent of that group, 29 patients, had no signs of lymphoma.
"These results are good, but whether it will turn out to be better than standard therapy is still unknown," says the study's lead author, Ivana Micallef, M.D. (http://mayoresearch.mayo.edu/mayo/research/staff/micallef_in.cfm), a Mayo Clinic hematologist.
Epratuzumab is much like rituximab because both are monoclonal antibodies, and both attach to proteins commonly found on the surface of B-cells — CD20 for rituximab and CD22 for epratuzumab. Both also are used to treat certain autoimmune disorders, such as rheumatoid arthritis and lupus. "In autoimmune disease, you are trying to stop the B-cells from making the antibodies that cause inflammation, but in cancer, these B-cells are malignant," says Dr. Micallef.
This is the first large study to combine epratuzumab with chemotherapy, in this case R-CHOP.
The rate of toxic side effects among enrolled patients was the same as seen in R-CHOP use, investigators say. "Overall, the combination was well tolerated," says Dr. Micallef. Patients may experience low blood counts, fatigue or infections.
As promising as these results look, researchers will not know if this new treatment provides superior results to R-CHOP unless the two regimens are compared with each other, she says.
Other NCCTG collaborators included Matthew Maurer, Paul Kurtin, M.D., and Thomas Witzig, M.D., all of Mayo Clinic; Daniel Nikcevich, M.D., St. Mary's Duluth Clinic, Duluth, Minn.; Michael Cannon and Dennis Moore, M.D., both of Cancer Center of Kansas PA, Wichita.
NCCTG is a national clinical research group sponsored by the National Cancer Institute. Its research and administration are based at Mayo Clinic. NCCTG consists of a network of cancer specialists at community clinics, hospitals and medical centers in the United States, Canada and Mexico. The group is dedicated to bringing clinical trials with promising new cancer therapies to communities where patients live.
Saturday, May 24, 2008
Emory Crawford Long Hospital a First to Use High-Tech Robotic Catheter for Treatment of Abnormal Heart Rhythm
A high-tech computer, a joystick, sound effects and three large computer monitors. No, it is not the latest video game. Instead, it's a new robotic catheter system used at Emory Crawford Long Hospital to treat irregular or abnormal heartbeats. The hospital, part of Emory Healthcare, is the first in the Southeast to use the new system.
Called the Sensei, the robotic catheter system is used to treat patients with arrhythmias, a heart condition where electrical impulses of the heart are abnormal. These abnormalities can cause the heart rate to be too slow or too fast, or sometimes, the heart rhythm can be erratic.
"This new robotic system offers more precise movements and stability when guiding a catheter through the heart for radiofrequency ablation," says David DeLurgio, MD, director of the electrophysiology labs at Emory Crawford Long Hospital. "The system is also operated remotely and allows the physician to sit during the procedure, which helps doctors reduce fatigue during long or multiple cases."
Radiofrequency ablation is a nonsurgical procedure used to treat some types of arrhythmias, particularly rapid and uncoordinated heartbeats. It's the preferred treatment for this disorder and has a success rate of over 90 percent, along with low risks of complications.
Using live X-ray, a doctor guides the robotic catheter with an electrode at its tip into the heart. Then the doctor places the tip at the exact site inside the heart where cells are giving off electrical signals that stimulate the abnormal heart rhythm. Mild and painless radiofrequency energy (similar to microwave heat) is transmitted to the target area. This destroys carefully selected heart muscle cells in a very small area (about 1/5 inch). The treatment stops the area from conducting the extra impulses that cause the rapid heartbeats.
"We've been doing manual radiofrequency ablation for various arrhythmias for 15 years at Emory Crawford Long Hospital, because it is tried and true," says DeLurgio, an associate professor of medicine (cardiology), Emory University School of Medicine. "The benefits of now using the robotic catheter are its accuracy and improved control over the tip of the catheter."
Another benefit is reducing the doctor's exposure to radiation from the live X-rays, because the system is remote. Electrophysiologists like DeLurgio can do as many as five cases each day, so exposure reduction is a plus.
"Because Emory Crawford Long Hospital's Heart and Vascular Center is a high-volume heart center, performing nearly 500 ablation cases a year, this new technology will be advantageous to both our patients and doctors," says DeLurgio.
The robotic catheter is made by Hansen Medical and is covered by most insurance companies.
Fayette Front Page
News You Can Use
Fayetteville, Peachtree City, Tyrone
Mayo Clinic Researchers Aim to Improve Asthma Patients' Care Through Computer-based Simulation Program
mdash - Mayo Clinic pulmonary researchers have designed and tested a new patient education computer program intended to help people with asthma manage their disease. The program allows asthma patients (an estimated 7 percent of the U.S. adult population) to practice making key decisions in a safe, simulated environment.
The Mayo Clinic group will present results of a study assessing users' experiences at the American Thoracic Society's 2008 International Conference in Toronto.
To improve delivery of asthma patient education messages, the Mayo team created a user-friendly tool called CASPER (Computerized Asthma Self-management Program and Educational Resource for adults). CASPER is an interactive story-based, Web-enabled asthma simulation program to enhance patients' ability to consistently treat their asthma. To progress through CASPER, patients answer questions displayed on the screen following a simulated asthma-attack scenario, such as "Bob's Night Time Wakening." The scenario portrays a familiar asthma event in pictures and text, and asks patients how to treat it. In response to the choice they enter on the computer, patients receive a comment that explains the best action to take in the story scenario, as well as why the other choices are not as effective.
This type of education is needed, researchers say, because learning how to manage asthma can be challenging for patients. They have a range of triggering events to anticipate, varied medications to take, and multiple methods for doing so, such as choosing from among long-term steroids, quick-relief inhalers and over-the-counter medications.
Patient self-management of asthma requires intensive education, says Kaiser Lim, M.D., a specialist in pulmonary and critical care medicine and lead researcher on the project. "Imagine if we are able to empower our patients by simulation and have them learn vicariously," he says. "We envision that this phase of patient education will come after the initial teaching sessions, and it will allow patients to synthesize all the information we have imparted."
Overall, the computer-based experience was positive for users, Dr. Lim says, showing promise as a tool that can help manage disease and control medical costs. "It is well documented that there is an increasing need for innovative educational programs for chronic disease self-management," he says. "But before we can judge the efficacy of this approach, the usability of these programs must be systematically and rigorously evaluated, and that's what we've begun to do with CASPER."
This story-based Web-based simulation approach to patient education holds high potential for improving management of other diseases as well. It can be used to address other pressing health problems, such as how to manage insulin, perform exercise, make food choices, and monitor hypertension and congestive heart failure, Dr. Lim says.
To assess the effectiveness of this educational approach, the Mayo researchers recruited 20 patients who had been diagnosed with asthma. The study articipants used the computer program with minimal instruction while a usability expert evaluated ease of use. More data from the patients' experience was gathered through surveys after patients used the omputer program and from brief interviews about the experience.
Reaction to CASPER
Results from observing and interviewing asthma patients using the computer education program show that CASPER's strengths include its:
* Story-based format. Patients generally found the narratives engaging, enjoyable and easy to f ollow.
* Use of Q&A structure. This organizational technique helped clarify messages.
* Ease of navigation. Even without instruction from a person on how to use the computer program, patients generally progressed as intended through the sequence of educational messages.
* Completion rate. Most users finished each asthma scenario as intended.
Researchers also found that several design elements of CASPER need further refinements, such as preventing detours from the intended messages through hyperlinks that distract from the delivery of a consolidated message.
The research demonstrated two main points about improving the effectiveness of patient-centered, computer-based education programs for adult asthma patients:
* Usability guidelines aren't enough to assure optimal use. Target-audience testing is required, too. Even when the components of design were based on established usability principles, the resulting application still had to be tested by the target audience to fine-tune its operation. Barriers to optimal utilization that emerged in target-audience testing included navigational issues, screen layout, consistency in content and design.
* A story-based, question-and-answer format is effective and helpful in the patient-centered, computer-based education setting for teaching adults about asthma management. Study participants confirmed the desirability of this approach, reporting that they found the program educational, engaging and entertaining.
Collaboration and Support
Other members of the Mayo Clinic research team are Kristin Vickers Douglas, Ph.D.; Marie Ivnik; Thomas Suther and Julie Hathaway. Montgomery Flinsch and his web team collaborated on the project. Their work was supported by the Mayo Foundation for Medical Education and Research.
The standard 8-hour business day is no longer the norm in America, according to the National Sleep Foundation’s (NSF) 2008 Sleep in America poll. The poll reports the average American’s work day is now nine hours and 28 minutes, while the average time spent in bed is six hours and 55 minutes – with six hours and 40 minutes spent actually sleeping. NSF recommends getting at least seven to nine hours of sleep each night. May is Better Sleep Month, and Piedmont Fayette Hospital encourages anyone concerned about their sleep habits to contact their physician.
There are more than 80 different forms of sleep disorders affecting people of all ages, and more than 70 million Americans have a sleep disorder. NSF found that sleep deprivation and sleep disorders are estimated to cost Americans more than $100 billion annually in lost productivity, medical expenses, sick leave, and property and environmental damage. Common symptoms of sleep disorders to be aware of are daytime fatigue, inability to sleep for long periods of time, and breathing difficulties during sleep.
“Everyone’s sleep needs are different, so when patients ask me how many hours of sleep they should get each night, I tell them sleep needs are individual and not only do different age groups need different amounts of sleep, but the amount of sleep one person needs to function best may be different than for someone else who is the same age and gender,” said Connie White-Daniel, RPSGT, clinical manager of the Piedmont Fayette Hospital Sleep Center.
According to NSF some of the biggest “sleep stealers” are stress, jet lag, shift work, lifestyle stressors, such as drinking alcohol and exercising close to bedtime, environmental interferences such as temperature or noise, physical factors, such as arthritis or back pain, and medications. Some tips for getting good sleep include:
· Avoiding caffeine, nicotine and alcohol in the late afternoon and evening.
· Exercising regularly, at least three hours before bedtime.
· Only using the bed for sleep.
· Establishing a regular, relaxing bedtime routine to “signal” the brain it is time to sleep.
· Avoiding napping during the day if having trouble sleeping at night.
Some of the more common sleep disorders are insomnia, sleep apnea and snoring. Insomnia is an experience of inadequate or poor quality sleep as characterized by one or more of the following sleep complaints: difficulty initiating and maintaining sleep and waking too early in the morning. Obstructive sleep apnea is a disorder in which breathing is briefly and repeatedly interrupted during sleep and can cause fragmented sleep and low blood oxygen levels. Snoring is defined as “breathing during sleep with hoarse or harsh sounds as caused by the vibrating of the soft palate.” Snoring can be a marker of sleep apnea, a risk factor for vascular complications such as hypertension, and it may lead to daytime dysfunction due to the fragmented sleep resulting from snoring.
The Piedmont Fayette Hospital Sleep Center is currently a four-bed sleep center expanding to six beds in late June and is the only hospital-based sleep center in the county that provides full-service diagnostic capabilities for people with sleep disorders. An experienced, multidisciplinary team of doctors, sleep technologists and other sleep disorder specialists provide total and comprehensive care for adults and children who have difficulty falling asleep or staying asleep, excessive daytime sleepiness, insomnia, snoring, sleep apnea and other sleep-related conditions. Talk to your doctor if you are experiencing problems related to sleep or for more information call the Sleep Center at 770-719-6031 or visit www.fayettehospital.org.
Friday, May 23, 2008
The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, the ingredients contained in the product may be harmful to nursing infants.
Potentially harmful ingredients in Mommy's Bliss Nipple Cream are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.
Mothers and caregivers should watch for a decrease in an infant's appetite. More serious signs would be difficulty in awakening the child, limpness of extremities or a decrease in an infant's strength of grip and a change in skin color. Please seek immediate medical attention if your child is showing these signs and symptoms.
"The FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," said Janet Woodcock, M.D., director, FDA's Center for Drug Evaluation and Research. "Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants."
Though the FDA has not received any reports of injury to infants, the agency is alerting the public because of the potential harm this product can have on a child.
Chlorphenesin can also harm the mother by causing dermatitis, a skin condition that can worsen the drying and cracking of nipple skin.
MOM Enterprises, Inc. is based in San Rafael, Calif. The company has stated that it has discontinued marketing the nipple cream with the potentially harmful ingredients. The FDA is advising consumers to discontinue use of Mommy's Bliss Nipple Cream and to consult a health care professional if they experience problems or believe that their infant may have experienced problems due to this product. Nursing mothers with cracked, painful nipples, which is often a side effect of nursing, should speak with their health care professional or a certified lactation consultant if the problem is severe or for other treatment options.
Consumers are strongly encouraged to report adverse events related to this product or any FDA approved product to MedWatch, the agency's voluntary reporting program, by e-mail at www.fda.gov/medwatch/report.htm, or by phone at 800-332-1088, or by fax to 800-332-0178. Consumers may also mail reports of adverse events to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.
When surgeons need to remove part of the pancreas, performing the operation with minimally invasive techniques offers patients a shorter hospital stay and fewer complications, researchers have concluded.
A study of more than 660 operations to remove pancreatic tumors and cysts over five years found that after laparoscopic surgery, patients stayed a third less time in the hospital without experiencing more complications such as leaks.
David Kooby, MD, assistant professor of surgical oncology at Emory University School of Medicine and the Emory Winship Cancer Institute, will present his findings at the American Surgical Association meeting in New York.
During laparoscopic surgery, doctors make smaller incisions than in traditional surgery and monitor their progress with fiber optics and video cameras. The less invasive approach has become well accepted for gallstone removal, repair of stomach valves and weight loss surgery, Kooby says.
"Data on patient outcomes has been scarce when it comes to extending this approach to the surgical care of other organs," he says. "Still, more surgeons and institutions are doing these procedures and more patients and referring doctors are requesting them. Our study shows that this approach is not only viable but may be preferable for the pancreas."
He and colleagues at eight universities across the Midwest and Southeast collected information on left pancreatectomies, where part but not all of the pancreas is removed, from 2002 to 2006. About a quarter were attempted laparoscopically.
About half the operations had complications, and a sixth had a leak of pancreatic fluid, the researchers found. Laparoscopic procedures had fewer complications (40 percent v. 57 percent) than standard surgery, and patients experienced lower blood loss and stayed about six days in the hospital compared with the standard nine.
New Study Shows Colorectal Cancer Screening Rates Increasing Among U.S. Adults - Disparities in screening still persist in certain populations
The percentage of U.S. adults aged 50 years and older getting screened
for colorectal cancer is increasing according to a study released by the
Centers for Disease Control and Prevention's (CDC) Morbidity and
Mortality Weekly Report. The study uses state-level Behavioral Risk
Factor Surveillance Survey (BRFSS) data that have been combined to
estimate that 60.8 percent of adults were current with colorectal cancer
screening recommendations in 2006, compared with 53.9 percent in 2002.
"While we are encouraged to see an increase in colorectal cancer
screening rates, certain groups are still not getting screened as
recommended," said Djenaba A. Joseph, M.D., the report's lead author
and medical officer, Division of Cancer Prevention and Control. "We
need to ensure that all adults have access to these life-saving tests
because there is strong scientific evidence that screening can prevent
colorectal cancer deaths."
Screening prevalence was lower among all racial and ethnic minorities
studied compared to whites. The study also reports that screening rates
continue to be lower among those without health insurance, with low
income, and with less than a high school education.
Colorectal cancer is the nation's second leading cause of cancer deaths.
In 2004, almost 145,000 people in the United States were diagnosed with
colon cancer and more than 53,000 died from the disease.
Regular screening is recommended for men and women beginning at age 50,
using one or a combination of these screening tests:
* Home Fecal occult blood test (FOBT) - a test that checks for
hidden blood in the stool.
* Colonoscopy - an examination of the rectum and entire colon
using a colonscope (a lighted instrument).
* Flexible sigmoidoscopy - an examination of the rectum and lower
colon using a sigmoidoscope (a lighted instrument).
* Double contrast barium enema - a series of x-rays of the entire
colon and rectum.
Screening tests for colorectal cancer can find precancerous polyps
(abnormal growths) in the colon and rectum before they turn into cancer.
Screening also helps find this cancer at an early stage when treatment
can be most effective.
To estimate the current rates of colorectal cancer screening and to
measure changes in use of screening, CDC scientists compared data from
the 2002, 2004, and 2006 BRFSS telephone surveys. For this report,
sigmoidoscopy and/or colonoscopy are described as lower endoscopy.
Significant findings from this study show:
* The percentage of adults aged 50 years and older who reported
having had a home FOBT within one year and/or lower endoscopy within 10
years before the survey increased from 54 percent in 2002, 57 percent in
2004, and to 60 percent in 2006.
* The percentage of adults who reported having had a home FOBT
within one year before the survey declined from 22 percent in 2002, 19
percent to 2004, and to 16 percent in 2006.
* The percentage of adults who reported having had lower endoscopy
within 10 years before the survey increased from 45 percent in 2002, to
50 percent in 2004, and to 56 percent in 2006.
* The percentage of adults who reported never being screened for
colorectal cancer decreased from 34 percent in 2004, 32 percent in 2004,
and to 30 percent in 2006.
* In 2006, the percentage of adults who reported having had a home
FOBT and/or lower endoscopy within 10 years before the survey ranged
from 52 percent in Mississippi to 71 percent in Connecticut.
To address the disparities in screening, in 2005, CDC established
colorectal cancer screening demonstration programs at five sites in the
United States for persons with low income and inadequate or no
colorectal cancer screening insurance coverage. Additional information
about these programs is available at
CDC's Screen for Life: National Colorectal Cancer Action Campaign is
aimed at informing men and women aged 50 years or older about the
importance of having regular colorectal cancer screening tests.
Information about Screen for Life can be found at
Speak with your doctor or health care professional about getting
screened for colorectal cancer, using one or more of the recommended
Thursday, May 22, 2008
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.
“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” Secretary Leavitt said. “We are moving from reactive dependence on voluntary reporting of safety concerns -- to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services.”
In a white paper released by the FDA today, the agency describes plans for the Sentinel Initiative, which will include the development of a new electronic system that will enable FDA to query a broad array of information to identify possible post-market adverse events. That Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.
A CMS final regulation published today will make it possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program (Part D) -- subject to protections for beneficiary privacy and commercially sensitive data -- for public health and safety research, quality initiatives, care coordination and other research and analysis.
The Sentinel System is an important example of how electronic health records and other electronic health information, such as the Medicare data, can help move the nation toward a system that delivers safer and better quality health care. President Bush has set the goal of most Americans having access to an interoperable electronic health record by 2014.
FDA’s Proposed Sentinel System Will Strengthen Safety Monitoring of Drugs and Other Medical Products
The new FDA white paper, titled “The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety,” describes the proposed Sentinel System and calls for a public-private collaboration to develop and implement it. The report is available at: http://www.fda.gov/oc/initiatives/advance/reports/report0508.html. The system would enable FDA to analyze significantly more information than it can today by tapping into vast databases of health information to detect early signs of emerging safety problems.
“With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people,” said FDA Commissioner Andrew C. von Eschenbach, M.D. “The era of ‘wait and see’ is going to become the era of ‘tell me right now.’ By harnessing the world’s most powerful information technologies, and by partnering with CMS, the VA and DoD, and an array of private health care organizations, we will have the ability to monitor a product’s performance in millions of patients in real time. The Sentinel System will give us an unprecedented ability to detect problems as they first begin to surface.”
Creating an active surveillance system such as the Sentinel System was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. The recently passed Food and Drug Administration Amendments Act of 2007 (FDAAA) includes provisions that call for the development of such a system. As planned, the Sentinel System will fulfill some requirements of FDAAA while also meeting additional FDA needs.
Access to CMS Data Will Facilitate Public Health and Safety Research and Quality Initiatives
“We look forward to working with the FDA on the Sentinel Initiative,” said CMS Acting Administrator Kerry Weems. “There’s a clear nexus between the data collected through Medicare’s prescription drug program and the FDA’s role in protecting the public from adverse events. The public health and safety benefits from this cooperative venture with the FDA will be substantial.”
Weems noted that CMS’s most recent survey of beneficiaries indicates that people with Medicare use more than twice as many medications in a year as do other Americans. Medicare beneficiaries use an average of 28 prescriptions in a year, while those who consider themselves in poor health have about 45 prescriptions in a year (source: Medicare current beneficiary survey, 2004). In contrast, other Americans use about 13 prescriptions a year, according to a 2007 study by the Agency for Healthcare Research and Quality (http://www.ahrq.gov/news/nn/nn051607.htm). Medicare beneficiaries’ high usage of medications, coupled with numerous chronic health conditions, puts this population segment at higher risk of adverse drug events than other Americans and makes them the group most likely to see benefits from the FDA’s new Sentinel Initiative.
The Medicare Prescription Drug Benefit data, linked to Medicare inpatient and outpatient claims data, will allow the creation of a highly robust HHS database as the prototype for the Sentinel System. Publication of the Medicare Part D Claims Data Rule enables the FDA to use Part D claims data as the FDA explores drug safety questions related to particular products. Medicare’s Part D prescription drug program, implemented in January 2006, has generated claims data on medications used by the more than 25 million beneficiaries with prescription drug coverage under the benefit. Linking these data on prescription drug use to other Medicare claims information, including diagnoses, medical treatments, hospitalizations, and physician services, will provide the FDA, other agencies, and researchers with a powerful new tool to investigate potential drug safety problems and questions about health outcomes. With approximately 1 billion claims per year, the Medicare Part D database is unprecedented in size and scope and will be a valuable resource for patient safety analyses that will benefit not only Medicare beneficiaries but the entire nation.
Publication of the final rule today will enable CMS to use Medicare Part D claims data for research, program oversight and evaluation, care coordination, quality improvement, and performance measurement initiatives. In compliance with beneficiary privacy protections, as required by the Federal Privacy Act and HIPAA regulations, and while protecting commercially sensitive data, Medicare drug claims will be linked to other Medicare information on patient care, such as hospitalizations and physician visits, and made available to other federal agencies, state Medicaid programs, researchers, and beneficiaries for their personal health records.
CMS will be developing guidelines and workshops to inform researchers on how they can request these data.
The CMS final rule and a related fact sheet may be viewed at www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp
Emory Crawford Long Hospital will begin its celebration of 100 years caring for Atlanta's citizens with a series of historical tours of the hospital, as well as a new museum-quality historical exhibit that is now on display and available for preview in the hospital's Medical Office Tower (MOT).
The exhibit and tours are meant to not only celebrate the birth of one of Atlanta's oldest hospitals, but to reflect on the many medical "firsts" that have occurred within the Midtown Atlanta landmark.
"This is a unique and exciting opportunity for Emory Crawford Long to join with our community and employees as we reflect on the tremendous history of this institution, while also looking forward to an exciting future of serving Atlantans with the most cutting-edge, research-based medicine and technology," says Chief Operating Officer Dane Peterson. "The development of the beautiful exhibit that is now on display in what, ironically, is Crawford Long's newest and most modern facility, as well as guided walking tours led by Emory's own historian Ren Davis, will truly bring this hospital and its history to life."
Emory Crawford Long Hospital was officially "born" on October 21, 1908, when two physicians, Dr. Edward Campbell Davis and a former student of his, Dr. Luther C. Fischer, opened the 26-bed Davis-Fischer Sanatorium on Crew Street, near present-day Turner Field. With just 26 beds, the hospital quickly outgrew its capacity and by 1911, Davis and Fischer moved the hospital to its present site, opening an 85-bed Davis-Fischer Sanatorium on Linden Avenue.
In 1931, the hospital was renamed Crawford W. Long Memorial Hospital in honor of Dr. Crawford W. Long, the Georgia physician who discovered sulphuric ether for use as an anesthetic and was the first doctor to use anesthesia during surgery.
Today, Emory Crawford Long Hospital is a 511-bed community-based, acute care teaching facility staffed by approximately 950 Emory medical faculty and nearly 600 private practice community physicians. The hospital is well known for services in cardiology, cardiac surgery, gastroenterology and emergency medicine. Women's services include prenatal and postnatal education, bone density testing, mammography and obstetrics, with a specialization in high-risk pregnancy.
Walking tours of the hospital will primarily be administered by noted historian and native Atlantan Ren Davis. Davis, a project manager with Emory Healthcare, is an Emory alumnus and has been at Emory since 1976. He is a frequent contributor to the Atlanta Journal-Constitution and is the author of the book "Caring for Atlanta: A History of Emory Crawford Long Hospital."
The tours, which are open to the general public and free of charge, will be conducted during the following days and times:
Wednesday, June 4 -- 10:30am
Wednesday, June 11 -- 1:30pm
Wednesday, June 25 -- 3:30pm
The historical display exhibit is now on view in the atrium of the Medical Office Tower at Emory Crawford Long Hospital. The display has been masterfully created to show the medical impact our hospital has had, as well as describe key historical information throughout the years. In addition, visitors see specific panels that highlight Dr. Crawford Long and the Crawford W. Long Memorial Hospital School of Nursing. Some of the other many special exhibits in the display include:
• Laryngoscope - Instrument was designed by Dr. Linus J. Miller, an anesthesiologist at Crawford Long from World War II until he retired from practice in the mid-1960s. It is used on children to examine the interior of the larynx.
• Pocket case of medical instruments - Given by Dr. George P. Cuttino, belonged to Dr. George Washington Peddy (1834-1913), Newnan, GA. Donated by Woodruff Health Sciences Center Library at Emory University.
• Wooden Stethoscope - Given by Dr. Allen Bunce (Used by Dr. Francis Hodgson Orme, 1834-1913; great-grandson of Dr. Joseph Priestly. Donated by Woodruff Health Sciences Center Library at Emory University.
• Telegram -- Telegram sent by Herman Talmadge to Dr. Wadley Glenn that approved a new diagnostic and treatment center.
• Agnes Raoul Glenn marble -- Piece of the Agnes Raoul Glenn building, which was torn down in 2001 to build the new building, which currently houses Emory Winship Cancer Institute and Emory Crawford Long's educational conference room and classrooms.
• "Phenap" -- A copy of the Nursing School yearbook. The yearbook was named after a pain medication that the pharmacists made in the pharmacy at Emory Crawford Long Hospital from the 1940s through the 1960s.
• Y2K survival guide
• An Olympic flag from the 1996 Atlanta Olympics
• Other old-fashioned medical instruments
To schedule a free tour of the hospital, call Emory HealthConnection at 404-778-7777. The historical display can be viewed at any time without a reservation.
Hypertension is the most common chronic disease in the U.S. and is becoming a major health concern for Americans of all ages, says a University of Georgia specialist.
Hypertension, or high blood pressure, is excessive force of the blood on the blood vessels as it circulates. It can cause problems such as heart attack, heart failure, vision loss, stroke and kidney disease, says Connie Crawley, a nutrition and health specialist with UGA Cooperative Extension.
Know your numbers.
A healthy blood pressure is defined as a systolic pressure of 120 mm Hg and a diastolic pressure of 80 mm Hg. Hypertension is defined as a systolic pressure of 140 mm Hg or a diastolic pressure of 90 mm Hg or greater, said Crawley.
Although genetics and family history can influence hypertension, she said, unhealthy choices such as smoking, eating certain foods, inactivity and being overweight cause it, too.
Unless a person is experiencing extremely high blood pressure, there are typically no symptoms. The condition can often go untreated.
“It is important for people to keep track of their blood pressure and bring it to the attention of their healthcare provider if it is not in control,” she said. “Sometimes the health care professional is focusing on other health issues and may not notice an elevated blood pressure until the patient mentions it.”
Lose weight, reduce stress.
Lifestyle changes and medication are usually combined to treat the problem, she said.
Stress management is helpful in reducing hypertension. Beneficial practices include deep breathing, yoga, tai chi, meditation, exercise, prayer or reducing responsibilities, Crawley says.
When medication is prescribed, three to four medications may be needed to lower blood pressure to the desired range.
Weight loss can also prove beneficial to controlling hypertension.
“Losing weight helps the most if the person is overweight,” she said. “A person does not have to lose to an ideal body weight to see a positive result. Just a loss of 10 to 20 pounds is often enough to see an improvement.”
Becoming more physically active, quitting smoking, keeping alcohol intake at a moderate level and eating more healthy foods rather than salty restaurant and convenience foods can also help reduce hypertension.
Follow DASH diet.
Following the Dietary Approaches to Stop Hypertension, or DASH, diet has been proven to lower blood pressure up to 11 points, Crawley said.
“It is one of the few clinically proven meal plans to treat a disease,” she said.
The diet includes eating eight to 10 servings of fruits and vegetables, at least three servings of whole grains and three servings of nonfat dairy foods each day. Only one to two ounces of meat are allowed per meal. The diet also requires eating several servings of cooked legumes, like beans and peas, and nuts several times a week.
By Allie Byrd
University of Georgia
Allie Byrd is a student writer with the University of Georgia College of Agricultural and Environmental Sciences.
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
Wednesday, May 21, 2008
The Brain Tumor Foundation for Children has awarded Emory University scientist Erwin G. Van Meir, PhD, a $50,000 grant for pre-clinical research on two of the deadliest forms of pediatric brain tumors--gliomas and medulloblastomas.
"We are very grateful for the foundation support and all the dedicated individuals who helped raise these funds. Such efforts make a big difference," says Van Meir.
Van Meir will study a novel small molecule that may inhibit the role of a key protein, hypoxia-inducible factor (HIF-1). HIF-1 is linked to the malignant progression of tumors found in the central nervous system (CNS) and activates angiogenesis, the process that initiates the formation of new blood vessel needed for tumor growth.
"This is a very exciting opportunity," says Van Meir. "Using mouse models, we will be able to test for the first time a novel small chemical molecule as a candidate drug to treat the two most lethal forms of childhood cancer. We evidenced the anti-cancer action of this novel molecule discovered in our laboratory in 2006, and now we will be able to test whether its action extends to pediatric brain tumors. This study provides new hope for children with brain tumors who urgently need new treatments."
Brain tumors are the second-leading cause of cancer deaths in children younger than 15 and the most common type of childhood cancer. Each year, roughly 2,000 children are diagnosed with brain tumors. Treatment may include surgery, radiation therapy and chemotherapy.
Van Meir, who joined Emory in 1998, is the director of the Laboratory for Molecular Neuro-Oncology and the co-director of the Emory Winship Cancer Institute Brain Tumor Program. He has devoted his research career to the study of brain tumors, studying the biology and genetics of these cancers and developing new experimental therapies. His laboratory has recently focused on drug discovery with the aim of translating new findings of anti-cancer activity in mouse models to accelerated testing in patients. For more information visit http://neurosurgery.emory.edu/FacultyVanMeir.htm
"It takes a lot of dedication by many talented individuals, and we have been fortunate to have incredible collaborators without which these discoveries would not have been possible," says Van Meir. "Our small molecule work has greatly benefited from collaborations with the laboratories of Kyriacos C. Nicolaou at the Scripps Research Institute in La Jolla, Binghe Wang at Georgia State University, Ruiwen Zhang at the University of Alabama in Birmingham and Mark Goodman at Emory University.
The Brain Tumor Foundation for Children focuses on providing emotional and informational support to families of children with brain tumors, public education and awareness of the disease, and raising funds to support research for a cure and for the improvement in the treatment and the quality of life of those with pediatric brain tumors. http://www.braintumorkids.org
Fayette Front Page
News You Can Use
Fayetteville, Peachtree City, Tyrone
BUSINESS WIRE--Epilepsy.com, an award-winning patient care site, is providing accurate information regarding epilepsy and seizures to the public and the media in the wake of the reported seizure that hospitalized Senator Edward M. Kennedy (D-Mass) on May 17. The website www.epilepsy.com of which Harvard Medical School Professor of Neurology, Steven C. Schachter, MD, is Editor-in-Chief, is an online resource for more than 200,000 unique visitors and one million page views per month. Dr. Schachter is also Director of Research for the Department of Neurology at Beth Israel Deaconess Medical Center in Boston. We present here information and links to epilepsy.com that should be helpful in understanding this event.
What is a seizure? A seizure is a sudden surge of electrical activity in the brain that usually affects how a person feels or acts for a short time (http://my.epilepsy.com/101/ep101_seizure). Seizures are not a disease in themselves. Instead, they are a symptom of many different disorders that can affect the brain. Seizures can range from hardly noticeable to a convulsion (http://my.epilepsy.com/epilepsy/types_seizures).
What is epilepsy? Epilepsy is a neurological condition that affects the brain. Epilepsy is also known as a seizure disorder. Epilepsy is usually diagnosed after a person has had at least two seizures that were not caused by some non-neurological condition that secondarily affects the brain, such as extremely low blood sugar (http://my.epilepsy.com/101/ep101_epilepsy). Although epilepsy is often considered a disorder of childhood, it can begin at any age. The rate of newly diagnosed epilepsy is actually higher in seniors (elderly people) than in middle-aged adults.
What tests are usually performed when a person has their first seizure? Because there are many possible causes of seizures, a thorough medical history is obtained and a variety of medical tests are performed to determine the cause, if possible, and to evaluate the risk of further seizures. Among the tests typically done are blood tests, a test of the brainwaves called an electroencephalogram (EEG), and brain imaging tests such as CT and MRI scans (http://my.epilepsy.com/101/101_diagnosis). Very often, these tests do not reveal a cause.
What are the possible causes of seizures and epilepsy? There is a long list of possible causes (http://my.epilepsy.com/101/ep101_risks) because many of the conditions that affect brain function can possibly cause a seizure. The cause of recurrent seizures (epilepsy) that begin in later life cannot be determined in about half of the cases. Of those in whom the cause can be determined, the most common cause is strokes, including small ones that did not cause other symptoms.
When is treatment usually begun? If the medical evaluations and tests determine that a person has had more than one seizure, or that he or she is at substantial risk for a second seizure due to an identified problem with brain function, then therapy with medicines called “anticonvulsants” or “antiepileptic drugs” may be started (http://my.epilepsy.com/epilepsy/treatment; http://my.epilepsy.com/info/seniors_effectsmed).
What is appropriate first aid for seizures? Here are a few things you can do to help someone who is having a seizure of any kind (http://my.epilepsy.com/epilepsy/firstaid):
The mission of epilepsy.com is to inform and empower patients and families facing newly diagnosed epilepsy or those struggling with epilepsy that has resisted treatment. Epilepsy.com is the home of the Epilepsy Therapy Project. Co-founded by Chairman Warren Lammert, it is a not-for-profit corporation dedicated to a singular focus: overcoming the funding gaps and roadblocks that slow the progress of new epilepsy therapies from the lab to the patient.
The U.S. Food and Drug Administration approved Entereg (alvimopan) May 20, 2008, to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.
"Patients who have undergone abdominal surgery and are on pain medications often experience problems eliminating waste," said Joyce Korvick, M.D., deputy director, Division of Gastroenterology Products. "Entereg will help accelerate their recovery, improve bowel function, and get these patients back on a normal diet. As with all FDA-approved products, the agency will monitor Entereg throughout its life cycle."
FDA is approving Entereg with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. The REMS will include limits on dispensing of the drug.
In approving Entereg, FDA determined that a REMS is necessary to ensure that the benefits of Entereg outweigh its risks. The REMS will include restricting Entereg to inpatient use only, requiring that hospitals be specially certified, distribution of educational materials to health care professionals, and regular assessments of the effectiveness of the REMS.
Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery. POI can be a by-product of a patient taking opioid pain relievers, like morphine, prescribed after surgery which can slow or inhibit normal motility. Entereg works by blocking opioid effects in the bowel.
The recommended dose for Entereg is one 12 milligram (mg) capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to 7 days or not to exceed 15 doses. The product will only be available to hospitals and will come in blister packs that are marked "HOSPITAL USE ONLY." Entereg is not approved for use in pediatric populations.
The safety and efficacy of Entereg in post-operative patients were demonstrated in five studies that included 2,177 patients, of whom 1,096 received Entereg and 1,081 received placebo. Bowel recovery times ranged from 10 to 26 hours shorter for Entereg-treated patients compared to placebo-treated patients in the five studies. The most common side effects reported were low blood calcium levels, anemia and gastrointestinal problems, including constipation, dyspepsia (heartburn) and flatulence (excess bowel gas).
FDA has reviewed a 12-month study of Entereg in patients treated with opioid medications for chronic pain. In this study, there were more reports of myocardial infarctions in patients treated with a 0.5 mg dose of Entereg twice daily, compared with placebo-treated patients. This imbalance has not been observed in other studies of Entereg, including studies in patients undergoing bowel resection surgery who took 12 mg of Entereg, twice daily for up to seven days. A causal relationship with Entereg and myocardial infarction has not been established.
Consumers and health care professionals are encouraged to report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.
Adolor Corporation, the manufacturer of Entereg, is based in Exton, PA. Adolor and GlaxoSmithKline, London, England, are collaborating on the development and marketing of Entereg.