Thursday, January 31, 2008

Compound cuts cerebral palsy in preemies

NEW YORK - Doctors can cut the risk of cerebral palsy in half for very premature babies by giving their mothers magnesium sulfate just before they give birth, new research shows.

http://news.yahoo.com/s/ap/20080131/ap_on_he_me/pregnancy_cerebral_palsy

HEART TRANSPLANTS: DO MORE OR DO NONE, JOHNS HOPKINS STUDY SUGGESTS

Heart surgeons at Johns Hopkins have evidence to support further tightening rather than easing of standards used to designate hospitals that are best at performing heart transplants.

In a study to be presented Jan. 29 at the 44th annual meeting of the Society of Thoracic Surgeons in Fort Lauderdale, Fla., the Hopkins team recommends that the benchmark for designation as a high-volume hospital rise from 10 heart transplants per year to 14. High-volume centers consistently show higher survival and fewer complication rates.

However, the standard, which is officially set by the U.S. Centers for Medicare and Medicaid Services and which qualifies medical centers for federal reimbursement, was recently lowered from 12 per year to 10.

“The bar for patient safety, quality of care and survival needs to be set pretty high,” says senior study investigator and cardiac surgeon John Conte, M.D. “Our national health care system has to rethink which hospitals should do heart transplants, and in consultation with their physicians, patients need to evaluate these surgical volumes to see for themselves which hospitals have teams operating at their peak skill level.”

Conte and his team reviewed the patient records of 14,401 men and women who received a heart transplant in the United Stats between 1999 and 2006.

The study is believed to be the largest and most thorough review of survival rates after heart transplantation in hospitals, based on volume.

“Our results clearly demonstrate that current standards have been arbitrarily set too low,” says Conte, who is director of heart and lung transplantation at The Johns Hopkins Hospital.

“There is a certain threshold, a minimum number of surgeries needed to maintain the expertise of the entire transplant team,” he says, noting that a dozen or more highly specialized professionals are involved in each transplant case, including cardiac surgeons, cardiologists, anesthesiologists, transplant coordinators, intensive care nurses, immunologists, pathologists, pulmonologists, and technicians.

In the new study, researchers found that death rates one month and one year after transplant increased steadily at hospitals that performed fewer than 14 heart transplants per year, which was the case for a majority of the 143 U.S. medical centers licensed to perform them. Roughly a dozen institutions perform more than 20 cases annually - including The Johns Hopkins Hospital and the University of Maryland Medical Center - and fewer than 10 hospitals do more than 30 procedures, with no more than five sites performing more than 40.

Study results showed that the overall average death rate one year after surgery was 12.6 percent. However, patients had a 16 percent greater chance of dying in a hospital that performed fewer than five heart transplants per year and had the best chances of surviving, with a 30-day mortality rate of less than 1 percent, at a hospital that performed over 40 procedures per year. Patients at hospitals with volumes of less than 10 had an 80 percent greater chance of dying within a month.

Using a graph and statistical analysis, researchers showed that death rates flattened for the majority of patients in hospitals with heart transplant volumes at 14 or more per year.

Conte, an associate professor of surgery at The Johns Hopkins University School of Medicine and its Heart Institute, says heart-failure patients on transplant wait lists should consult with their cardiologists about hospital and surgeon volumes when making decisions about transplants.
Hopkins cardiologist and study co-investigator Stuart Russell, M.D., who has personally cared for more than 360 transplant patients in the past decade, says patients should also look for consistently high volumes over several years as well as overall survival rates for transplant programs.

One-year survival rates at The Johns Hopkins Hospital, he notes, consistently average above 90 percent.

Despite the team’s findings, Russell says it will take a clear shift in public health policy to move American medicine toward further concentration of volumes for complex procedures such as heart transplantation.

In the United Kingdom, he points out, centers designated to performed heart transplants are severely restricted, and volumes soar past 50 for each center.

“In the United States, too many low-volume hospitals have a program that they won’t let go of, no matter how poor the results,” says Russell, an associate professor at Hopkins.

More than 2,000 people undergo heart transplants each year in the United States. Nearly 3,000 remain on wait lists, and up to 20 percent of those on the list to receive a heart will die while waiting. Costs for a heart transplant often run as high as $260,000.

This study’s data were supplied by the United Network for Organ Sharing (UNOS), a national network that allocates donated organs across the country. Funding for the study was supplied in part by The Johns Hopkins Hospital.

Besides Conte and Russell, other Hopkins investigators involved in this study were lead researcher Eric Weiss., M.D.; Robert Meguid, M.D.; Nishant Patel, B.A.; Ashish Shah, M.D.; and William Baumgartner, M.D.

(Presentation title: Increased mortality rates at low-volume, orthotopic heart transplant centers; should the optimal volume for defining centers of excellence be increased?)

SECONDHAND SMOKE EXPOSURE WORSENS CYSTIC FIBROSIS

Researchers at Johns Hopkins have discovered the first genetic evidence that secondhand smoke can worsen lung disease. The report in this week’s Journal of the American Medical Association describes one gene variation that can weaken lung function as well as shorten the lifespan of those affected by cystic fibrosis and also are exposed to secondhand smoke.

“We’re really surprised that such a small genetic change can double the negative effects of secondhand smoke on lung function in these patients,” says Garry Cutting, M.D., a professor of pediatrics and medicine and member of the McKusick-Nathans Institute of Genetic Medicine.

“It’s always been suspected that secondhand smoke is detrimental to lung disease patients, and now we have a handle on one specific gene that clearly makes it worse for those with CF.”
Of the 812 participants in the study, 188 were exposed to secondhand smoke at home. The participants were recruited between 2000 and 2006 as part of the U.S. Cystic Fibrosis Twin and Sibling Study and the Cystic Fibrosis Foundation Data Registry.

The research team found that secondhand smoke exposure was associated with decreased lung function in CF patients, measured by how much air a person could breathe out in the first second of expiration. According to Cutting, any secondhand smoke exposure reduced lung function by 10 percent.

“We know by observation that some patients tend to do worse than others, so we wondered if genes played a clear role in how CF patients react to secondhand smoke,” says Cutting.
The research team went on to compare patient lung function with their particular genetic variant of CF as well as the genetic variant of another gene, TGFbeta1, which has been shown to affect the severity of CF and asthma.

CF patients who also carried particular TGFbeta1 mutations fared twice as badly in lung function when exposed to secondhand smoke compared with those who were not exposed. According to Cutting, secondhand smoke exposure is roughly equivalent to 7 years of lung function decline.

“This means that a 17-year old CF patient with a TGFbeta1 mutation and exposed to secondhand smoke would have lung function similar to that of a 24-year-old who wasn’t exposed to secondhand smoke,” says Cutting. “This gene-environment interaction drastically accelerates reduced lung function.”

The research was funded by the National Heart, Lung, and Blood Institute, the Cystic Fibrosis Foundation and the Flight Attendant Medical Research Institute.

Authors on the paper are J. Michael Collaco, Lori Vanscoy, Lindsay Bremer, Kathryn McDougal, Scott Blackman, Amanda Bowers, Kathleen Naughton, Jacky Jennings, Jonathan Ellen and Cutting, all of Hopkins.

Wednesday, January 30, 2008

Emory Bariatrics Program Receives Level 1 Accreditation from American College of Surgeons

The Emory Bariatric Center at Emory Crawford Long Hospital in Midtown Atlanta has been accredited as a Level 1 Bariatric Surgery Center of Excellence by the Bariatric Surgery Center Network (BSCN) Accreditation Program of the American College of Surgeons (ACS).

Established by the American College of Surgeons, the BSCN Accreditation Program provides confirmation that a bariatric surgery center has demonstrated its commitment to providing the highest quality care for its bariatric surgery patients.

"The American College of Surgeons accreditation is the most rigorous of its kind, and receiving this endorsement is an incredible achievement to be shared and celebrated by our team," says Edward Lin, MD, surgical director of the Emory Bariatrics Center. "We absolutely recognize morbid obesity as a serious disease that compromises quality of life and greatly increases the risk of mortality. This program approaches bariatric surgery from a complete interdisciplinary approach, with input from a wide array of experts who provide in-depth medical care, education, behavior modifications, psychological counseling and support before, during and after the surgery."

According to Emory Crawford Long Hospital Chief Operating Officer Dane Peterson, this designation means that Emory has met the essential criteria that ensures it is fully capable of supporting a bariatric surgery care program and that its institutional performance meets the requirements outlined by the ACS BSCN Accreditation Program.

"A tremendous amount of time and effort by many dedicated physicians, nursing and staff members have led to this successful accreditation," says Peterson. "This gold seal of approval now lets our patients and the communities we serve know that we provide the support and resources that are necessary to address the entire spectrum of care and needs of bariatric patients--from the pre-hospital phase through the postoperative care and treatment process."

As part of the two-year accreditation process, hospitals undergo an on-site verification by experienced bariatric surgeons, who review the center's structure, process and quality of data using the current ACS Bariatric Surgery Center Network Accreditation Program Manual as a guideline in conducting the survey. Because high-quality surgical care requires documentation using reliable measurements of outcomes, accredited bariatric surgery centers are required to report their bariatric surgery outcomes data either to the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) or the College's BSCN Database, using a Web-based data entry system.

The educational and personal support process is a long-term commitment to ultimate success that starts before a patient is even considered a candidate for weight loss surgery. Tracey Wilds, clinical nurse specialist in Bariatric and Surgical Services at Emory, managed the program nursing and educational aspects as part of the accreditation process. According to her, a patient's stay in the hospital is a small, albeit critical, percentage of time devoted to successful weight loss and lifetime of healthy living choices.

"Although the hospital length of stay is quite brief compared to the months of pre-surgical education, many disciplines of hospital staff are educated about the surgeries and sensitivity toward obese patients," says Wilds. "The staff care is important to the patients' transition to the next phase of their lives. A great deal of education is continued after discharge as well, because this is a lifelong commitment to their health."

Dr. John Sweeney, MD, professor of surgery in the Emory School of Medicine, notes that more than 11 million people suffer from severe obesity, and the numbers continue to increase--leading to a wide range of long term health problems.

"Obesity increases the risks of morbidity and mortality because of the diseases and conditions that are commonly associated with it, such as type II diabetes, hypertension, cardiovascular disease, cancer and musculoskeletal disorders, among other health risks," says Dr. Sweeney. "While diet and exercise are essential to healthy weight loss, morbid obesity often requires supplementary treatment such as bariatric surgery. This accreditation can now assure patients they will have access to the very best level of care and follow-up, which we provide at Emory."

Established as a multi-disciplinary weight-management program in 2000, the Emory Bariatric Center tailors each patient's treatment using a continuum of methods that respond to the rising risks that accompany increasing levels of obesity. These methods include nutrition and exercise therapy, lifestyle education, pharmacotherapy, liquid meal replacement and bariatric surgery. The center's multi-specialty team includes nurses, bariatricians, anesthesiologists, psychologists, dietitians, surgeons, physician assistants, exercise specialists and a dedicated team of administrative and managerial personnel.

The American College of Surgeons is a scientific and educational association of surgeons that was founded in 1913 to raise the standards of surgical education and practice and to improve the care of the surgical patient. Its achievements have placed it at the forefront of American surgery and have made the College an important advocate for all surgical patients. The College has more than 72,000 members and is the largest organization of surgeons in the world.

Family Education Day at Emory's Cystic Fibrosis Center

Emory University's Cystic Fibrosis Center is hosting a public education event on Saturday, Feb. 9 at the Emory Conference Center Hotel, 1615 Clifton Rd., from 8 a.m. to 2 p.m.

This meeting is intended to inform and educate everyone who is affected by cystic fibrosis, including parents, relatives, friends, teachers, coworkers and healthcare providers.

Featured speakers include Lisa Saiman, MD, MPH, professor of clinical pediatrics at Columbia University, who will discuss infection control guidelines; Preston Campbell, MD, executive vice president for medical affairs at the Cystic Fibrosis Foundation, who will report on the foundation's clinical research pipeline, and Andres Pelaez, MD, assistant professor of medicine at Emory University School of Medicine, who will describe advances in lung transplantation.

Cystic fibrosis, a genetic disease affecting 30,000 children and adults in the United States, impacts pulmonary function, digestion and reproduction. Symptoms include mucus in the lungs, lung infections, gastrointestinal problems and impaired breathing. The Cystic Fibrosis Foundation estimates that up to 10 million Americans are unknowing carriers of the mutations that cause the disease.

More information about Emory's Cystic Fibrosis Center, which serves more than 450 pediatric and adult patients annually, is available at:http://www.emoryhealthcare.org/departments/childcenter/services/cystic_fibrosis.html

Families who receive care at cystic fibrosis centers other than Emory's are welcome. The event is free.

If you are planning to attend, the Cystic Fibrosis Center requests a courtesy call by Monday, Feb. 4 at 404-727-8951.

New Report Provides Information on HIV Prevalence in the U.S. Household Population

Approximately half of 1 percent (0.47 percent) of the U.S. household population between the ages of 18 and 49 are living with HIV, according to estimates from CDC's National Center for Health Statistics (NCHS) based on surveys conducted between 1999-2006.

The findings are summarized in a CDC Data Brief issued today, which uses data from the National Health and Nutrition Examination Survey (NHANES) to provide a snapshot of HIV prevalence in the general U.S. household population ages 18-49. NHANES does not focus exclusively on populations that may be at high risk for HIV, such as men who have sex with men, injection drug users, homeless or incarcerated individuals. These data are roughly equivalent to NCHS' previous prevalence estimate for this population from a 1988-94 survey.

This report also does not include data on the number of individuals newly infected with HIV, known as incidence. New CDC estimates of annual HIV incidence are currently under development by CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP).

Key findings on HIV prevalence in 1999-2006 include:

* Men ages 18-49 are more likely to be infected (0.7 percent) than women (0.2 percent).
* Two percent of non-Hispanic black adults ages 18-49 were infected with HIV compared to 0.23 percent of white adults and 0.3 percent of Mexican-American adults.
* Adults aged 18-49 who are infected with the herpes simplex type 2 virus (HSV-2) are more than 15 times likely to also be infected with HIV. An estimated 2 percent of HSV-2 positive adults ages 18-49 also have HIV.

The full report is available at http://www.cdc.gov/nchs/data/databriefs/db04.pdf

THE MARCUS INSTITUTE CONTINUES STATEWIDE EXPANSION IN ALPHARETTA

“Turning Disabilities into Possibilities” may soon be everyone’s favorite phrase in Alpharetta since The Marcus Institute opened its fourth statewide clinic in this dynamic and growing community. This move is part of The Marcus Institute's plans for statewide expansion to meet the need for pediatric developmental disabilities treatment in Georgia. Other locations include Athens, Savannah and Columbus.

According to the recent findings by the Governor’s Council on Developmental Disabilities, there are not enough sub-specialists around the state providing services to this population. The Marcus Institute Alpharetta, at 3300 Old Milton Parkway, Suite 360, is the fourth of 10 Child Psychiatric Clinics to open throughout the state of Georgia. Dr. Helen Panarites at The Marcus Institute, will begin holding monthly clinics on the second and fourth Fridays.

"It is The Marcus Institute‘s mission to fill this void," said John R. Lutzker, Ph.D., executive director of The Marcus Institute. “Historically, families seeking treatment have had to travel to Atlanta. Soon The Marcus Institute’s services will be available throughout the state.”

The statewide expansion will increase access to services for children living outside of Atlanta. Clinics will accept both Medicaid and private insurance. Psychiatry will be the first clinical sub-specialty to be introduced; additional services will be added based on the needs of the particular community.

“Our goal is to help children with developmental and behavioral disabilities participate as fully as possible in family, school and community environments,” said Dr. Lutzker.

Any child who might be able to benefit from involvement in the clinic is welcome. The clinic is currently accepting referrals for new patients. If you would like to schedule an appointment, please contact the intake department at 404.419.5300.

Doctors and Dentists Account for 27 Percent of $1.6 Trillion in Health Care Revenue

Physician’s offices accounted for $331 billion in revenue in 2006, while the dental profession made up another $87 billion of the $1.6 trillion in revenue of the health care and social assistance sector, according to a U.S. Census Bureau report.

The report, 2006 Service Annual Survey: Health Care and Social Assistance, provides estimates such as revenue and sources of revenue for taxable and tax-exempt offices of physicians, hospitals, nursing care facilities and social assistance services. It covers firms with paid employees.

Health care and social assistance grew 6.1 percent in 2006, with a 7.2 percent increase the year before.

“The service industries make up about 55 percent of all economic activity in the country,” said Mark Wallace, chief of the Census Bureau’s Service Sector Statistics Division. “At $1.6 trillion in 2006, the health care and social assistance sector continues to play a strong role in the health of the U.S. economy.”

All four subsectors of health care and social services gained revenue from 2005. Revenue in 2006 was $654 billion for hospitals; $647 billion for ambulatory health care services, which includes offices of physicians, dentists and other health practitioners, such as chiropractors and optometrists; $149 billion for nursing and residential care facilities; and $117 billion for social assistance, which includes child and youth services, services for the elderly and community food services.

Other highlights:

- Kidney dialysis centers (11 percent) and social assistance services for the elderly and persons with disabilities (12 percent) both grew in 2006.

- The revenue for taxable employer firms in health care and social assistance sector was almost $779 billion, while tax-exempt employer firms was about $789 billion.

- Eighty-eight percent of hospital revenue comes from tax-exempt hospitals, while only 19 percent of the revenue of homes for the elderly comes from tax-exempt firms.

- Physician’s offices receive $163 billion of their revenue from health insurance; 34 billion comes directly from the patient.

- Medicare makes up 22 percent of physicians’ revenue, and Medicaid another 5 percent.

- At hospitals, patient out-of-pocket spending contributes $33 billion as a revenue source, while private health insurance adds $265 billion. Medicare and Medicaid represent $177 billion and $68 billion of revenue, respectively.

- Of the $31 billion of revenue for community care facilities for the elderly, $21 billion comes from the patient (equal to $6.77 of every $10), the largest source of revenue in this industry group.

The Service Annual Survey provides data that help measure America's service economy. This particular report focuses on health care and social assistance providers for individuals. Both health care and social assistance are included in this sector because sometimes it is difficult to distinguish between the boundaries of these two. The industries in this sector are arranged on a continuum starting with those establishments providing medical care exclusively, continuing with those providing health care and social assistance and finishing with those providing only social assistance. Trained professionals provide the services in this sector. All industries in this sector share this commonality of process, namely labor inputs of health practitioners or social workers with the requisite expertise. Many of the industries in the sector are defined based on the educational degree held by the practitioner.

Sunday, January 27, 2008

PIEDMONT PHYSICIANS OPENS NEW OFFICE IN JASPER; WELCOMES LOCAL FAMILY PHYSICIAN

Piedmont Physicians Group welcomes Richard D. Gonzales, M.D., to its healthcare team. He joins the Group after more than 20 years of experience practicing medicine. Beginning February 1, Dr. Gonzales will be seeing patients at the new Piedmont Physicians at Archway.

Dr. Gonzales is board-certified in family medicine. He obtained his medical degree from the University of the East Ramon Magsaysay Memorial Medical Center in the Philippines where he also completed a rotating clerkship. He completed his family practice residency at the Family Health Center at St. Clare’s Hospital in Schenectady, N.Y.

Prior to joining Piedmont Physicians at Archway, Dr. Gonzales was in private practice at Archway Medical Center and Parkway Medical Center. He is a member of the American Medical Association, American Academy of Family Practice, Georgia Academy of Family Physicians and American Arthritis Foundation.

"We are pleased to welcome such an exceptional physician to the Piedmont family,” said Berney Crane, President and CEO of Piedmont Medical Care Corporation, the administrative parent corporation of the Piedmont Physicians Group. “Dr. Gonzales’s vast experience in family medicine will be an asset to the Archway Medical practice."

Locally, he is a member the Cherokee-Pickens Doctors Association and the Pickens County Chamber of Commerce. He is fluent in Spanish and Filipino. Dr. Gonzales accepts most major insurance plans and is accepting new patients. The office is located at 735 Martin Road, Suite A in Jasper, Ga. Office hours are Monday, Tuesday, Thursday and Friday 8:30 a.m. to 5:00 p.m. and Wednesday 8:30 a.m. to 12:00 p.m. To schedule an appointment, call 706-253-3366.

Friday, January 25, 2008

Medical Operation Helps Iraqi School Children, Families

Hundreds of Iraqi school children and adults received medical care Jan. 16, when soldiers from the 101st Airborne Division's 1st Battalion, 320th Field Artillery Regiment, 2nd Brigade Combat Team, held a medical operation at central Baghdad's Swaib school.

Soldiers from 3rd Brigade, 6th Iraqi Army Division, handled outer security and crowd control, while Iraqi doctors, physicians, nurses, pharmacists and a dentist worked side by side with their American counterparts to meet the needs of Iraqi citizens.

Doctors saw nearly 300 children and 150 adults that day, said Army Capt. Melvin Jackson, civil affairs officer with 1st Battalion, 320th Field Artillery.

Only one physician, Dr. Abass, normally is available to react to the people's needs in the neighborhood, and he does not have a staff, money or resources to fully aid his fellow citizens, Jackson said.

Though Abass is regarded as a town hero because of his professionalism and demeanor to aid his Iraqi friends and neighbors, he can only do so much, said Sgt. Jason Torres, a medic with the 1-320th FA's personnel security detachment platoon.

Jackson recalled an Iraqi child about 6 years old who had an ear infection.

"Back in the states, if we had an ear infection we'd go see the local doctor and get the necessary antibiotics or medication to take care of it," Jackson said. "This kid had what I consider a mild ear infection, but because it was untreated or he just didn't have the access to a local doctor or medicine to treat it, he became very dizzy and disoriented, and it messed up his inner equilibrium."

The boy eventually was seen by a local doctor and was taken to the Abu Ghraib hospital outside the area and treated.

"Something mild became worse than it originally was, and for that reason they need local health care to deal with minor issues -- cuts, abrasions, flu -- before it turns into something major like pneumonia, severe ear infection or bronchitis," Jackson continued.

Jackson said he hopes the Iraqi Health Ministry recognizes Abass' clinic as a health care center and provides the clinic with health care personnel to help him treat the people in the area.

Jackson said the medical operation provided a chance for Iraqi and U.S. physicians to reach out to the people in Swaib.

"It highlights Iraqis helping Iraqis," he said. "You have the Iraqi army securing the event. You've got local-national nurses and doctors giving back to the community. Ultimately, the long-term effect of this is to get Iraqis to sustain themselves, and this is a small step towards that."

During the medical operation, the physicians saw everything from upper respiratory infections to toothaches, but the medical care is only a part of the operation's success, Torres said.

"I personally feel this builds a better relationship between us and the Iraqis. Especially when we talk about the medical field, we get to find out what our strengths and weaknesses are," he said. "Most importantly, it benefits the Iraqi people; they get the medical attention they need."

(Author Army Sgt. James P. Hunter serves in public affairs with the 101st Airborne Division's 2nd Brigade Combat Team.)

Thursday, January 24, 2008

PIEDMONT MOUNTAINSIDE HOSPITAL PRESENTS FIFTH ANNUAL CELEBRATE WOMEN FORUM

"The Heart of the Home" Program Features Keynote Speaker Stacey Speller

With so many of today's women performing a balancing act while trying to have it all, they still remain the heart of the home.

Join Piedmont Mountainside Hospital and renowned international speaker Stacey Speller for the 5th Annual Celebrate Women Forum entitled “The Heart of the Home” on Saturday, Feb. 16, from 8 a.m. to noon at the Education Center at Appalachian Technical College. The morning seminar will include lectures on a variety of heart-healthy topics including women's physical health, mental health, and healthy eating habits.

The keynote speaker, Stacey Speller is a highly sought-after author, life coach, and columnist. Her speech entitled "Overcoming Stress and Finding Balance in One's Life," will address her passionate belief that everyone should discover their own unique gifts, talents and purpose, and that all things are possible. As a busy professional, wife and mother, Speller is well versed in the concept of "having it all" and contends that people "can have it all, just not necessarily all at one time."

"I know the women in our community will enjoy hearing Stacey speak about ways to overcome stress in work and in life,” said Regina Camp, director of community relations for Piedmont Mountainside Hospital. “Her message of balance resonates with women of all ages all over the country, including women here in the north Georgia community.”

In addition to Speller's words of wisdom, local physicians will discuss a range of women’s health topics related to maintaining a healthy heart.

The following individuals will lead discussions:

Carl McCurdy, M.D., family medicine, presenting "Maintaining a Happy Heart"
Louise Brown, RD, registered dietician, presenting "Eating for a Healthy Heart"
Kenneth Austin, M.D., cardiology, presenting "My Heart's Desire - Taking Care of Me"

The morning seminar will also include entertainment by Georgia Marie Cagle as well as a variety of health screenings. A meal will be provided and participants can enter to win a number of door prizes. Cost is $20, and registration is required. For more information, please call 706-301-5300.

The Zone Groundbreaking at Children’s Healthcare of Atlanta at Scottish Rite Scheduled for NHL All-Star Weekend

Country Music Star Garth Brooks, NHL Commissioner Gary Bettman, NHLPA Executive Director Paul Kelly and Thrashers Executive V.P., G.M. and Head Coach Don Waddell to Participate in Special Event on Sunday, Jan. 27

A special groundbreaking ceremony will take place at Children’s Healthcare of Atlanta at Scottish Rite on Sunday, Jan. 27 from 10:30 a.m. to 12 p.m. to introduce The Zone, a state-of-the-art educational and therapeutic environment for children and their families being built within the hospital.

Speakers at the groundbreaking ceremony include Garth Brooks, National Hockey League Commissioner Gary Bettman, National Hockey League Players’ Association Executive Director Paul Kelly, Thrashers Executive Vice President, General Manager and Head Coach Don Waddell and Children’s Healthcare of Atlanta CEO Jim Tally, PhD.

As Official Children’s Charity of the NHL and NHLPA, The Zone is underwritten by the Garth Brooks Teammates for Kids Foundation, which raises funds from professional athletes, including several Atlanta Thrashers players, and other donors to provide financial assistance to children’s charities.

The event will take place in the hospital’s auditorium and will include a special video presentation that will provide a virtual tour of The Zone and a tour of the future site of the facility.

In partnership with the Garth Brooks Teammates for Kids Foundation, The Zone has already been completed at five hospitals throughout the United States, including the Medical Center of Dallas, Texas Children’s Hospital in Houston, Cook Children’s Medical Center in Fort Worth, Oklahoma City Children’s Hospital and Kravis Children’s Hospital at Mount Sinai in New York City.

The groundbreaking ceremony is part of the festivities surrounding the 2008 NHL All-Star Weekend at Philips Arena, which is highlighted by the Dodge/NHL SuperSkills on Saturday, Jan. 26 at 7 p.m. and the 56th NHL All-Star Game on Sunday, Jan. 27 at 6 p.m.

For more information, visit www.teammatesforkids.com or www.choa.org.

Emory Eye Center First in U.S. to Conduct Innovative Keratoconus Clinical Trial

Emory Eye Center is the first U.S. site to conduct an innovative clinical study on patients with keratoconus. The condition causes a bulging or steepening of the cornea that can lead to, in some cases, scarring of the cornea, or corneal ectasia, a similar condition that can occur after refractive surgery.

The new treatment, a minimally invasive, quick procedure, involves riboflavin eye drops that are applied to the patient's cornea and activated by an ultraviolet light. In European studies, the treatment has been shown to increase the amount of collagen cross-linking in the cornea, thereby strengthening it. Cross-linking refers to the natural collagen "anchors" in the corneal tissue. A stronger cornea will not tend to steepen in the way that a diseased cornea steepens.

The cornea is the clear or transparent front section of the eye, covering the iris and pupil. It lets light through, and its curvature causes light to bend, providing the eye's focusing or refractive power. With keratoconus or corneal ectasia, a typical patient has moderate to very severe blurriness of vision. Keratoconus and corneal ectasia together account for 15 percent of the corneal transplants in the United States.

In the past, managing keratoconus has included at the earliest involvement, glasses and/or rigid gas permeable contact lenses. When the condition has advanced to the corneal scarring point, a corneal transplant may be indicated. About half of keratoconus patients have no real problems with their lifestyle other than corrective lenses. The condition may even stabilize. For others, the condition can be resolved only by penetrating keratoplasty (PKP), often known as corneal transplant or corneal graft. In some cases, keratoconus can reoccur in that grafted cornea.

The new trial, which will include about 300 patients may "revolutionize the practice of cornea and ophthalmic external disease treatments," says R. Doyle Stulting, MD, PhD, a cornea specialist at Emory Eye Center and principal investigator for the clinical trial.

"This therapy represents a revolutionary method of treating a degenerative eye disorder," says Timothy W. Olsen, MD, director of Emory Eye Center and the F. Phinizy Calhoun Sr. Chair of Ophthalmology. "Many people suffer from this condition, and we are excited that Dr. Stulting will treat the very first patients in the United States with this innovative new procedure at the Emory Eye Center. Dr. Stulting's expertise is uniquely suited to conduct this seminal trial that could help stabilize and improve the vision for many affected individuals."

Dr. Stulting explains, "This new treatment shows promise for not only treating keratoconus, but for treating ectasia or keratectasia. It could also be helpful in treating endothelial dystrophy or Fuchs' dystrophy."

Fuchs dystrophy is an inherited condition that affects the delicate inner layer (endothelium) of the cornea It is progressive and patients gradually lose the endothelial cells, leading to corneal clouding and reduced vision.

"In addition," says Dr. Stulting, "the riboflavin treatment may also help those with corneal melting caused by certain auto-immune diseases as well as those with infectious keratitis resistant to traditional antibiotics."

Dr. Stulting has been on the forefront of numerous clinical trials in past years, most notably the seminal FDA trials on LASIK. His areas of expertise include: a variety of refractive surgery procedures, the management of corneal and external eye diseases, corneal transplantation, and cataract surgery.

The clinical trial, called Collagen Cross-Linking with Riboflavin, or CXL, is enrolling patients at Emory at this time; for more information please call 404-778-6155.

Wednesday, January 23, 2008

Arthritis Foundation Announces Top 10 Arthritis Advances of 2007

PRNewswire-USNewswire/ -- A team of engineers have recently created a new framework upon which cartilage tissue can be grown. The novel scaffold is porous, so the fabric can be seeded with cells and transplanted into a joint damaged by arthritis. The woven "fabric" will be absorbed by the body, leaving only healthy, strong cartilage for those who suffer from osteoarthritis or other cartilage injuries. This is just one of the top 10 most significant arthritis advances of 2007, according to the Arthritis Foundation.

The Arthritis Foundation's annual Top 10 Arthritis Advances also includes a survey released by the Centers for Disease Control and Prevention (CDC) quantifying the high cost of arthritis, in which arthritis-attributable work limitation affects one in three working-age adults (aged 18-64 years) with doctor-diagnosed arthritis. Another important advance this past year was the first ever quantification of the number of children with juvenile arthritis and documentation of the severe shortage of pediatric rheumatologists to provide diagnosis and care for children with juvenile arthritis in the United States. Moreover, several approaches were identified to increase access to subspecialty care by pediatric rheumatologists, which include enhancing the availability and financing of fellowship training to increase the number of trainees in the field and also improving the financial viability of pediatric rheumatology practices in academic settings.

"As the prevalence of arthritis continues to soar in the United States, advances made in 2007 provide the groundwork for improving the lives of the 46 millions people who live with arthritis now and the 40% more projected to be affected by 2030," said John H. Klippel, M.D., president and CEO of the Arthritis Foundation. "With arthritis being the most common cause of disability, advances in research and the development of more effective and safer treatments will continue to contribute in helping to improve the quality of life for people with arthritis."

The Arthritis Foundation's Top 10 Arthritis Events of 2007 include:
-- Passage of FDA Legislation on Drug Regulation and Safety
-- Quantification of Work Limitation and Earnings Losses

-- Projections of Increases in Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation

-- Identification of RA Susceptibility Genes STAT4 and TRAF1-C5
-- Uncovering the Importance of Cadherin-11
-- Development of a Woven Mesh for Cartilage Engineering
-- Approval of Lyrica for Treatment of Fibromyalgia
-- Availability of NIH's Osteoarthritis Data and Images
-- Quantification of Children with Arthritis and Number of Doctors Needed
-- Evidence of Benefit and Safety of Biologic Therapy in Children

Summaries of each of the top arthritis advances, as well as what they mean for arthritis patients are available at http://www.arthritis.org/top-10-2007.php

To develop its fifth annual list of the Top 10 Arthritis Advances, the Arthritis Foundation sought input from clinicians with expertise in various forms of arthritis, scientists from a wide variety of research disciplines, and organizations with an interest in arthritis and related diseases.

PIEDMONT HOSPITAL URGES GEORGIA WOMEN TO GET SCREENED

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

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

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

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

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

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

Tuesday, January 22, 2008

NIH Announces New Initiative in Epigenomics

The National Institutes of Health (NIH) will invest more than $190 million over the next five years to accelerate an emerging field of biomedical research known as epigenomics.

"Disease is about more than genetics. It's about how genes are regulated — how and when they work in both health and disease," said NIH Director Elias A. Zerhouni, M.D. "Epigenomics will build upon our new knowledge of the human genome and help us better understand the role of the environment in regulating genes that protect our health or make us more susceptible to disease."

The NIH is making this a priority in its research portfolio, taking it on as an NIH Roadmap initiative. Grant applications are now being accepted for research on epigenome mapping centers, epigenomics data analysis and coordination, technology development in epigenetics, and discovery of novel epigenetic marks in mammalian cells.

Epigenetics focuses on processes that regulate how and when certain genes are turned on and turned off, while epigenomics pertains to analysis of epigenetic changes across many genes in a cell or entire organism.

Epigenetic processes control normal growth and development. Diet and exposure to environmental chemicals throughout all stages of human development among other factors can cause epigenetic changes that may turn on or turn off certain genes. Changes in genes that would normally protect against a disease, as a result, could make people more susceptible to developing that disease later in life. Researchers also believe some epigenetic changes can be passed on from generation to generation.

The Epigenomics Program is a trans-NIH effort led by several NIH institutes including the National Institute of Environmental Health Sciences, the National Institute on Drug Abuse (NIDA), the National Institute on Deafness and Other Communication Disorders, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, and the National Center for Biotechnology Information of the National Library of Medicine. Efforts of these Institutes are coordinated by the Office of Portfolio Analysis and Strategic Initiatives (OPASI) as part of the NIH Roadmap.

"Epigenetic mechanisms are important in development, aging, and learning and memory, but our understanding of epigenetic processes is still very much in its infancy," said NIDA Director Nora D. Volkow. "A deeper understanding of epigenetics will enable researchers to make significant strides in understanding and treating many diseases including cancers, obesity, depression, and addiction."

Increased interest in epigenetics has spawned international research collaborations that have pushed the field forward in recent years. With the NIH Roadmap initiative, the United States will increase its commitment to epigenetics research and accelerate the pace of biomedical discovery in the next decade.

For example, epigenetics may help explain how some people are predisposed to certain illnesses such as cardiovascular disease, diabetes and hypertension. Several studies have documented that children born to mothers who did not get adequate nutrition during pregnancy were more likely to develop type 2 diabetes and coronary heart disease later in life. The theory is that epigenetic changes occur in genes that regulate sugar absorption and metabolism during fetal development that allow for survival with little food, but when encountered with an environment where food was plentiful these changes led to development of diabetes. (See scientific illustration of how epigenetic mechanisms can affect health at http://nihroadmap.nih.gov/epigenomics/epigeneticmechanisms.asp.)

"Although we are beginning to understand a great deal about the basic science of epigenetics, this initiative heralds its application to human health and disease. This initiative will connect real life problems with cutting edge science," said Dr. Alan Krensky director of OPASI.

NIH hopes to achieve the following goals with the Epigenomics Program:

Coordinate and develop a series of reference epigenome maps, analogous to genome maps, which will be publicly available to facilitate research in human health and disease.

Evaluate epigenetic mechanisms in aging, development, environmental exposure including physical and chemical exposures, behavioral and social environments, and modifiers of stress.
Develop new technologies for epigenetic analysis of single cells and imaging of epigenetic activity in living organisms.

Engage the international community to define standard practices and platforms, to develop new laboratory tools such as antibodies.

The overall hypothesis of the NIH Roadmap Epigenomics Program is that the origins of health and susceptibility to disease are, in part, the result of epigenetic regulation of the genetic blueprint. Researchers believe that understanding how and when epigenetic processes control genes during different stages of development and throughout life will lead to more effective ways to prevent and treat disease.

Additional information about the Epigenomics Program is available at http://nihroadmap.nih.gov/epigenomics/. For more information about funding opportunities, go to: http://www.nihroadmap.nih.gov/hmp/grants.asp.

Studies paint mixed health picture of caffeine

LONDON (Reuters) - Two new studies paint a conflicting health picture for women coffee drinkers, with one suggesting caffeine may lower the risk of ovarian cancer and the other showing it doubles the chances of miscarriage.

http://news.yahoo.com/s/nm/20080122/ts_nm/cancer_ovarian_caffeine_dc

Studies Highlight MRSA Evolution and Resilience

Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infections are caused primarily by a single strain — USA300 — of an evolving bacterium that has spread with "extraordinary transmissibility" throughout the United States during the past five years, according to a new study led by National Institutes of Health (NIH) scientists. CA-MRSA, an emerging public health concern, typically causes readily treatable soft-tissue infections such as boils, but also can lead to life-threatening conditions that are difficult to treat.

The study, from the National Institute of Allergy and Infectious Diseases (NIAID) of NIH, resolves debate about the molecular evolution of CA-MRSA in the United States. The findings rule out the previously held possibility that multiple strains of USA300, the most troublesome type of CA-MRSA in the United States, emerged randomly with similar characteristics. The study also offers a hypothesis for the origin of previous S. aureus outbreaks, such as those caused by penicillin-resistant strains in the 1950s and 1960s.

A second study led by the same NIAID scientists takes the issue of the evolution of MRSA a step further, revealing new information about how MRSA bacteria in general, including the USA300 group, elude the human immune system.

The first study, which appears online this week in the Proceedings of the National Academy of Sciences, found that the USA300 group of CA-MRSA strains, collectively called the epidemic strain, comprises nearly identical clones that have emerged from a single bacterial strain. It is the first time scientists have used comparative genome sequencing to reveal the origins of epidemic CA-MRSA. Frank R. DeLeo, Ph.D., at NIAID's Rocky Mountain Laboratories (RML) in Hamilton, Mont., led the research.

"Scientists are pressing ahead quickly to learn more about how some MRSA strains evade the immune system and spread rapidly," says NIAID Director Anthony S. Fauci, M.D. "The information presented in these two studies adds important new insights to that expanding knowledge base."

To understand how CA-MRSA is evolving in complexity and spreading geographically, Dr. DeLeo's group sequenced the genomes of 10 patient samples of the USA300 bacterium recovered from individuals treated at different U.S. locations between 2002 and 2005. They then compared these genomes to each other and to a baseline USA300 strain used in earlier studies. Eight of the 10 USA300 patient samples were found to have nearly indistinguishable genomes, indicating they originated from a common strain. The remaining two bacteria were related to the other eight, but more distantly.

Interestingly, of the eight nearly indistinguishable USA300 patient samples, two caused far fewer deaths in laboratory mice than the others, highlighting an emerging view that tiny genetic changes among evolving strains can profoundly affect disease severity and the potential for drug resistance to develop.

"The USA300 group of strains appears to have extraordinary transmissibility and fitness," says Dr. DeLeo. "We anticipate that new USA300 derivatives will emerge within the next several years and that these strains will have a wide range of disease-causing potential." Ultimately, Dr. DeLeo and his colleagues hope that the work will lead to the development of new diagnostic tests that can quickly identify specific strains of MRSA.

Fred C. Tenover, Ph.D., of the Centers for Disease Control and Prevention in Atlanta (CDC) contributed the 10 USA300 clinical isolates from CDC's Active Bacterial Core Surveillance system. Other study collaborators included Barry N. Kreiswirth, Ph.D., of the International Center for Public Health (ICPH) in Newark, N.J., and James M. Musser, M.D., Ph.D., of The Methodist Hospital Research Institute in Houston.

The second report, which involved scientists from RML, ICPH and Vanderbilt University Medical Center in Nashville, was recently published online in the Journal of Immunology. This study provides scientists with new details about the complex mechanisms MRSA uses to avoid destruction by neutrophils, human white blood cells that ingest and destroy microbes. When exposed to hydrogen peroxide, hypochlorous acid (the active component of household bleach) or antimicrobial proteins — all killer chemicals released by neutrophils — MRSA senses danger, escapes harm and turns the tables on the white blood cells, destroying them. Work is continuing in Dr. DeLeo's lab to understand how the bacterium senses and survives attacks by neutrophils.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

Bird flu hits India as Turkey and Indonesia detect cases

KOLKATA, India (Reuters) - An outbreak of bird flu in India's most densely populated state could spiral out of control, officials said on Tuesday, as the disease spread to a seventh district.
http://news.yahoo.com/s/nm/20080122/ts_nm/birdflu_dc

Folk medicines contain lead

HOUSTON - Maria didn't mean to poison her children. Quite the opposite. Worried about her daughters' lack of appetite, the young Houston mother was merely following her grandmother's advice when she gave the two girls and a niece a dose of "greta" — a Mexican folk medicine used to treat children's stomach ailments

http://news.yahoo.com/s/ap/20080122/ap_on_he_me/dangerous_remedies

Monday, January 21, 2008

Debunking Top Health Myths Even Doctors Believe

(SPM Wire) Do you think that you need eight glasses of water a day, that reading in dim light damages your eyes or that eating turkey makes you sleepy? Think again.

In a study entitled "Medical Myths Even Doctors Believe" published in the "British Medical Journal," Indiana University School of Medicine researchers explored some commonly held and untrue medical beliefs.

The researchers studied various myths -- including those seemingly age-old beliefs that people only use 10 percent of their brains and that hair and fingernails continue to grow after we die.

The surprising findings are that all these beliefs were unproven or untrue.

"We got fired up about this because we knew that physicians accepted these beliefs and were passing this information along to their patients… We didn't set out to become myth busters," said the study's co-author Dr. Aaron Carroll, assistant professor of pediatrics and a Regenstrief Institute, Inc. affiliated scientist.

The first belief they explored was that people should drink at least eight glasses of water a day. This advice has long been promoted as healthful as well as a useful dieting or weight control strategy.

"When we examined this belief, we found that there is no medical evidence to suggest that you need that much water," said Dr. Rachel Vreeman, a pediatrics research fellow and co-author of the new study.

She thinks this myth can be traced back to a 1945 recommendation from the Nutrition Council. But an important part of the Council's recommendation has been lost over the years -- the large amount of fluid contained in food, especially fruits and vegetables, as well as in the coffee and soda people drink each day should be included in the recommended total.

Indeed, drinking excess water can be dangerous, resulting in water intoxication and even death, the study authors note.

Even before Abe Lincoln was told that reading in dim candle light was bad for his eyes, people have believed that reading in dim light causes permanent eye damage. And ever since, generation after generation of parents have thusly admonished children caught reading with flashlights under their blankets.

However, the new study found no evidence that reading in dim light causes permanent eye damage. It is true that eye strain can occur in dim light, causing some temporarily decreased acuity, but after rest the eyes return to their full potential.

And don't worry about falling asleep at the dinner table after gnawing on a turkey drumstick.

Yes, scientific evidence supports that tryptophan, which is contained in turkey, can cause drowsiness. However, turkey doesn't contain an exceptional amount of tryptophan. In fact, turkey, chicken, and ground beef contain about the same amount of tryptophan and protein sources like pork and Swiss cheese contain more tryptophan per gram than turkey.

So why do people believe eating turkey makes them sleepy but never feel that way after a burger or pork chop? This myth most likely gained credence because turkey is often consumed during large, heavy dinners. It's the total content of the meal that makes one feel lethargic.

Dr. Vreeman and Dr. Carroll also explored the popular belief that we use only 10 percent of our brains. MRI scans, PET scans and other imaging studies show no dormant areas of the brain, and even viewing individual neurons or cells reveals no inactive areas of the brain. Metabolic studies of how brain cells process chemicals show no nonfunctioning areas.

This myth probably originated with self improvement experts in the early 1900s who wanted to convince people that they had yet not reached their full potential. With the help of these self proclaimed experts one could tap into the 90 percent of the brain supposedly not being used.

The study also showed that finger nails and hair do not grow after death and that shaved hair does not grow back faster, coarser or darker, among other popularly-held incorrect medical myths.

Sunday, January 20, 2008

Army Aims to Better Identify Soldiers with Brain Injuries

By C. Todd Lopez
Special to American Forces Press Service


An Army report released yesterday outlines how the service can better identify and help soldiers who have suffered traumatic brain injuries.

The report contains some 47 recommendations to help the Army better prevent, screen, diagnose, treat and research traumatic brain injury, said Brig. Gen. Donald Bradshaw, who led the task force charged with investigating TBI. Bradshaw is commander of Southeast Regional Medical Command and Eisenhower Regional Medical Center, at Fort Gordon, Ga.

"Our report indicates that, like our civilian counterparts, the Army has done well in the identifying and treatment of severe or penetrating traumatic brain injury, but is challenged to understand, diagnose and treat personnel who have suffered short-term or persistent symptoms of mild TBI," he said. "The task force identified opportunities for improvement as well as best-practice guidelines."

The general said 80 percent of those who suffer from mild TBI, commonly known as a concussion, recover completely. Some 10 to 20 percent of soldiers and Marines returning from Iraq and Afghanistan with experience in combat may have suffered symptoms consistent with mild TBI.

Today, eight of the recommendations made by the task force have already been implemented, said Col. Judith Ruiz, deputy director for rehabilitation and reintegration with the Office of the Surgeon General.

"We have made significant progress to take care of soldiers and to standardize practices across the Army medical department," she said.

Some of the recommendations that have already been implemented include:

-- Working with interagency and civilian groups to better define TBI;

-- Implementing in-theater TBI screening and documentation for all soldiers exposed to brain injury-inducing trauma;

-- Adding TBI-specific questions to deployment-related health assessments;

-- Developing a proposal on the appropriate functions of a "TBI center of excellence";

-- Proposing the Defense and Veterans Brain Injury Center as the core of the new center of excellence;

-- Optimizing the positioning of clinical, educational and research activities;

-- Centralizing the evaluation of the scientific merit, clinical utility, and priority of new treatment strategies, devices or interventions; and

-- Adapting the Military Acute Concussion Evaluation overprint as an approved Department of the Army form to document mild TBI closest to the point of injury.

Ruiz said 31 additional recommendations are in progress, four are planned, and four are in the process of being transferred to other agencies.

For soldiers in theater, the most common cause of brain injury is a blast, such as from an improvised explosive device. But sometimes such blasts do not cause visible external injuries.

"Brain injury does not have to have outside symptoms, such as bleeding," Bradshaw said. "It may, but doesn't have to. That is one of the compounding things; folks may look totally normal, but be dazed."

Because some victims of IEDs or other blasts do not have external injures, they may feel they have not been injured at all -- even if they did sustain a mild TBI.

"It's hard to identify TBI when soldiers don't come forward and don't identify," Bradshaw said. "Some of the actions that have been taken (include) a very big ongoing education process for leaders, soldiers and family members."

The Army launched the post-traumatic stress disorder/mild traumatic brain injury chain teaching program in 2007 to help soldiers better identify signs and symptoms of these conditions and to reinforce the collective responsibility to take care of each other.

The Army is also working to educate the civilian medical community about mild TBI so that soldiers in the reserve components, who may not have full-time access to military medical care, also can be identified, said Col. (Dr.) Jonathan Jaffin, deputy commander of the U.S. Army Medical Research and Material Command.

"One of the things we are concerned with and ... one of the points behind the whole chain teaching was trying to get the message out to the country, not just the active-duty force, Guard and reserve," he said. "(We wanted) the country, including providers throughout the country, to be aware of mild TBI and concussions and the long-term symptoms that some people may be having."

Bradshaw said Army leaders at all levels are committed to the good health and well-being of all soldiers and are proactively addressing the issue of TBI. "Continued research in this area can only help us more clearly understand the medical impacts of the war and the best ways to prevent, recognize and treat soldiers with TBI," he said.

(C. Todd Lopez works for the Army News Service.)

FDA Clears for Marketing Real-Time Test for Respiratory Viruses

Molecular biology device detects four viruses, including influenza; results available in about 3 hours

The U.S. Food and Drug Administration has cleared for marketing a test that simultaneously detects four common respiratory viruses, including the flu, in a patient’s respiratory secretions. The ProFlu+ test provides results in as few as three hours. Other diagnostic tests for respiratory viruses are fast but not as accurate or are accurate but not as rapid.

The real-time test employs a multiplex platform that allows several tests to be processed using the same sample to detect influenza A virus, influenza B virus, and respiratory syncytial virus A and B (RSV).

These viruses can cause influenza, an infection of the airways called bronchiolitis, and pneumonia. All are among the leading causes of lower respiratory tract infections.

“Antiviral drugs are most effective when initiated within the first two days of symptoms,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “This new test, which is part of the new era of molecular medicine, can help the medical community quickly determine whether a respiratory illness is caused by one of these four viruses and initiate the appropriate treatment.”

ProFlu+ uses a molecular biology process to isolate and amplify viral genetic material present in secretions taken from the back of the throat in patients.

While ProFlu+ is faster than conventional tests, it is specific to the four viruses, and is more accurate when used with other diagnostics, such as patient data, bacterial, or viral cultures, and X-rays, in diagnosing a patient. Positive results do not rule out other infection or co-infection and the virus detected may not be the specific cause of the disease or patient symptoms.

An estimated 5 percent to 20 percent of the U.S. population contracts influenza each year, resulting in more than 200,000 hospitalizations and up to 36,000 deaths. Influenza A, one of three types of human influenza, is the most severe and has been the cause of major epidemics. Influenza B is less severe than influenza A.

Bronchiolitis usually affects children under the age of 2, and is a common, sometimes severe illness. A common cause of the disease is RSV.

Pneumonia is a common illness that affects millions of people each year in the United States and is usually caused by an infection. People most at risk are older than 65 or younger than 2 years of age, or already have health problems.

ProFlu+ is manufactured by Prodesse, Inc. of Milwaukee.

Saturday, January 19, 2008

FDA Approves New HIV Drug After Priority Review

Etravirine tablets used in combination with other antiretroviral agents

The U.S. Food and Drug Administration today approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.

Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme which HIV needs to multiply. The drug was approved to be used in combination with other anti-HIV medications. Sold under the trade name Intelence, etravirine received a priority review by the FDA.

Development of etravirine was triggered by the observations of in vitro anti-HIV activity of etravirine against mutant, NNRTI-resistant HIV strains.

"This is another significant new product for many HIV-infected patients who are NNRTI –resistant and whose infections are not responding to currently available medications," said Debra B. Birnkrant, M.D., director of the FDA's Division of Antiviral Products.

When used with other active anti-HIV medicines and when taken as prescribed, etravirine reduces the amount of HIV in the blood and increases white blood cells that help fight off other infections. In addition, etravirine may reduce the risk of death or infections that can occur with a weakened immune system.

The FDA's approval of etravirine is based primarily on data from 599 adults who received etravirine in two randomized, double-blind, placebo-controlled trials. After 24 weeks of treatment, more of the patients who received etravirine along with background therapy experienced reductions in the level of HIV in their blood than did those who received a placebo and background therapy.

The most common adverse events reported were rash and nausea. Patients developing a rash while taking etravirine should contact their doctor. To avoid drug interactions, patients starting etravirine treatment should tell their prescribers and pharmacists about all the medications they take. Information about drug interactions is contained in the etravirine package insert.

In the overall development program for etravirine, rare cases of serious skin reactions such as Stevens-Johnson syndrome and erythema multiforme were reported. Patients taking etravirine may develop infections, including opportunistic infections or other conditions that may develop in patients living with HIV infection. The long-term effects of etravirine are not known, and its safety and effectiveness in children ages 16 years and younger has not been studied.

Etravirine also has not been studied in pregnant women. Women who are taking HIV medications when they become pregnant are advised to consult their physician or other health care professional about use of etravirine during pregnancy and about registering with the Antiviral Pregnancy Registry.

Etravirine is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., based in Bridgewater, N.J.

Friday, January 18, 2008

FDA Approves Update to Label on Birth Control Patch

The U.S. Food and Drug Administration (FDA) today approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.

The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE.

"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

"This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products."

In September 2006, FDA revised the label for Ortho Evra to warn women of the risk of VTE based on two epidemiology studies. One study, conducted by i3 Ingenix, showed that some women using the patch were at a two-fold greater risk of developing VTE. The other study, conducted by BCDSP, showed they were not at increased risk compared to women using birth control pills containing 30-35 micrograms of estrogen and the progestin norgestimate.

Ortho Evra is a prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen. Increased levels of estrogen may increase the risk of side effects, including VTE. Women should discuss with their health care provider the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily.

The FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.

The Ortho Evra Contraceptive Transdermal Patch is manufactured by Ortho McNeil Pharmaceuticals, a division of Johnson and Johnson.

Consumers with questions regarding this drug or any medications may contact FDA's Division of Drug Information at: 888-INFO-FDA (888-463-6332), or email to: druginfo@fda.hhs.gov.

To view additional information on the use of Ortho Evra please visit: www.fda.gov/cder/drug/infopage/orthoevra/default.htm

Pap Tests as Important as Ever for Cervical Health

(BUSINESS WIRE)--January is Cervical Health Awareness Month, and there’s no better time than now for women to catch up on the latest information about cervical health and testing.

The American Cancer Society estimates that in 2007, approximately 11,150 cases of invasive cervical cancer were diagnosed in the United States and nearly 3,670 women died from cervical cancer. Although this is still too many cases of preventable illness and death, it represents a significant improvement over historic rates. From 1955 to 1992, there was a 74% reduction of cervical cancer-related deaths, and this rate continues to decrease by approximately 4% per year. Earlier and more accurate diagnosis will allow continued improvement in outcomes for women diagnosed with cervical cancer.

According to LabCorp, an industry leader in cancer testing, one major achievement that has led to this decline was the development and general acceptance of the Pap smear or Pap test.

The Pap test requires a health care provider to remove a sample of cells from the cervix which are then affixed to a glass slide, stained with a dye to reveal the different cells and studied under a microscope by a cytotechnologist or a pathologist. The Pap can detect early stages of cancer, when it is most manageable, or identify pre-cancerous changes in the cervix before cancer develops.

In 2003, the FDA approved a test to directly detect the DNA of HPV in the cervical cells that are used for the Pap. The HPV DNA test accurately detects the HPV itself. “Knowing a woman’s HPV status allows doctors to determine when additional tests or procedures are needed and to initiate treatment before cancer can develop,” states Dr. Myla Lai-Goldman, Executive Vice President, Chief Scientific Officer and Medical Director of LabCorp. Pap with HPV testing is the recommended screening approach for women age 30 and older.

In 2006, the FDA approved the first vaccine effective against four HPV strains, two of which cause about 70 percent of cervical cancers. The FDA recommends the vaccine for women between the ages of nine and 26, before they are sexually active. The vaccine has the potential to dramatically reduce the incidence of cervical cancer in the United States. However women who receive the vaccine still need to have appropriate Pap tests. “Regardless of whether a woman has been vaccinated, regular Pap tests are an integral part of maintaining cervical health,” said Dr. Lai-Goldman.

LabCorp performs more than 10 million Pap tests annually and recommends that all women visit their physician to discuss what testing options are best for them.

Focusing on Food and Fitness: State Strategies for Healthy Communities and Economic Development

Friday, February 8, 2008
12 noon-1:30pm EST/11am-12:30pm CST/10am-11:30am MST/9am-10:30am PST

Americans' growing girth - 66 million Americans are overweight or obese - has health officials and policymakers concerned. Excess weight can lead to diabetes, heart disease and stroke, and other chronic conditions. These health conditions strain state health care systems and budgets.

Many states are looking at ways to increase access to nutritious food, build physical activity into daily routines, with safe pedestrian walkways, parks, and recreation, especially in low-income neighborhoods. This webcast will provide listeners with a state legislative perspective on increasing nutritious food and fitness options and how they are intertwined with economic development in our communities.

Speakers: Michael Hamm, PhD: C.S. Mott Professor of Sustainable Agriculture, Michigan State UniversityRepresentative Dwight Evans: Chair, House Appropriations Committee (Pennsylvania)TBD

This event is FREE for the first 50 registered participants thanks to generous grant funding from the W.K. Kellogg Foundation.

Click here to register.

For questions about registration for this event, please contact Lisa Castro
For questions about program content, please contact Melissa Hansen
Please read guidelines on how to join an event or view recorded events.

FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products

Products should not be used in children under 2 years of age; evaluation continues in older populations

The U.S. Food and Drug Administration today issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds.

There are a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness.

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2."

The announcement does not include the FDA's final recommendation about use of OTC cough and cold medicines in children ages 2 to 11 years. The agency's review of data for 2-to-11-year-olds is continuing. The FDA is committed to making a timely and comprehensive review of the safety of OTC cough and cold medicines in children. The agency plans to issue its recommendations on use of the products in children ages 2 to 11 years to the public as soon as the review is complete.

Today's statement is based on the FDA's review of data and discussion at a joint meeting of the Nonprescription Drugs and Pediatric Advisory Committees on Oct. 18 and 19, 2007.

Pending completion of the FDA's ongoing review, parents and caregivers that choose to use OTC cough and cold medicines to children ages 2 to 11 years should:

Follow the dosing directions on the label of any OTC medication,
Understand that these drugs will NOT cure or shorten the duration of the common cold,

Check the "Drug Facts" label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients, and
Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs.

The FDA recommends that anyone with questions contact a physician, pharmacist or other health care professional to discuss how to treat a child with a cough or cold.

For more information and the full list of the FDA's recommendations, visit:
Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children
http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm
Questions and Answers for Consumers http://www.fda.gov/consumer/updates/coughcold011708.html

Thursday, January 17, 2008

New Discoveries Confirm and Enhance CombiMatrix's Microarray Test for Autism

(PRIME NEWSWIRE) -- CombiMatrix Corporation (Nasdaq:CBMX) announced that today's publication in the American Journal of Human Genetics by Dr. Steve Scherer and colleagues further implicate genomic copy number variation (CNV) in the etiology of Autism Spectrum Disorder (ASD) elevating the importance of the CBMX ATScan(tm) 1.0 microarray test. The study reports the discovery of a chromosome 16p11.2 region in one percent of ASD patients identical to that described last week in the New England Journal of Medicine (Daly et al., NEJM), as well as numerous additional previously unreported ASD-risk genes. CBMX is proud to announce that, as a function of its unparalleled ability to rapidly enhance and clinically validate its genomic arrays, these new loci exist or are being added to the ATScan(tm) 1.0 establishing the CBMX platform as the most up-to-date and comprehensive diagnostic test of its kind for ASD. Moreover, as a function of CBMX's commitment to responsible and affordable diagnostics testing, the enhanced ATScan(tm) remains priced as the most affordable comparable test in the industry. We encourage physicians and patients to contact us at 949-753-0624 for more information.

In the American Journal of Human Genetics publication, researchers at the Hospital for Sick Children (SickKids) in Toronto discovered several new genomic variations, increasing the number of identified CNV regions associated to ASD. Dr. Steve Scherer, senior scientist in Genetics & Genomic Biology at SickKids and professor of Molecular Genetics at the University of Toronto noted that, "Our finding of CNVs in seven percent of autistic children not seen in their parents or controls has important clinical implications. Our data indicates that the application of microarrays can have great utility in clinical assessment of undetected syndromes underlying ASD, making it crucial to rapidly translate our basic research discoveries into validated clinical tests available to families," he said.

Dr. Mansoor Mohammed, President and CEO of CombiMatrix Molecular Diagnostics noted that, "We have dedicated considerable effort in mining the literature and leveraging our partnerships to move significant evidence-based research into quality-assured clinical diagnostics. These recent discoveries validate our business plan to establish ourselves as the preeminent provider of genome-based diagnostics. Not only am I proud to see the fruition of our efforts in the rapid development and deployment of our ATScan(tm) test, but also of the exciting pipeline of products we are currently developing and our commitment to their clinical relevance and affordability."

The following are links to the American Journal of Human Genetics article referenced above, as well as the press release from the Hospital for Sick Children (SickKids): http://www.ajhg.org/AJHG/latestarticles; http://www.sickkids.ca/mediaroom/custom/structuralchanges08.asp.

FDA Approves First Clotting Solution Made Using Recombinant DNA Technology

The U.S. Food and Drug Administration today approved the first clotting solution manufactured using recombinant DNA techniques to help stop small blood vessels from bleeding after surgery.

The new solution, called Recothrom, is a topical thrombin solution. Thrombin is a protein involved in the production of fibrin, a different protein necessary for blood to clot.

Recombinant DNA is the result of a genetic modification process that enables scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.

After surgery, bleeding from small blood vessels, such as capillaries, can cause significant blood loss. Physicians can apply Recothrom during surgery when standard surgical techniques for stopping blood loss are ineffective or impractical.

“With today’s approval, surgeons can choose recombinant thrombin, thrombin derived from human plasma or thrombin derived from cattle plasma to help control surgical bleeding and oozing,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.

Recothrom is made from Chinese Hamster Ovary cells (CHO), which have been genetically modified to produce human thrombin. These CHO cells are free from known infectious agents, and Recothrom undergoes an additional process of viral inactivation.

In a study of 411 patients undergoing various surgical procedures, Recothrom met the primary indicator of effectiveness, which was control of bleeding within 10 minutes. Recothrom was also evaluated on secondary indicators of effectiveness, which were control of bleeding within three and six minutes. These measures of Recothrom’s effectiveness were not inferior to ones displayed by the study’s active control, a licensed topical thrombin derived from cattle plasma.
Adverse events reported during the studies included incision site complications and pain related to the surgical procedure, and nausea.

Recothrom is manufactured by Seattle-based ZymoGenetics, Inc.

Traffic Pollution Increases Respiratory Problems in Children

Exposure to traffic pollution may increase respiratory problems and reduce lung volumes in children with asthma, according to researchers.

The study, reported in the second issue for December of the American Journal of Respiratory and Critical Care Medicine, looked at the effects of road and traffic density on children's lung function and respiratory symptoms in Ciudad Juarez in Mexico.

"Our results show that close proximity to vehicular traffic-related emissions, either at home or at school, can lead to chronic effects in the respiratory health of children with asthma," says Fernando Holguin, MD, MPH, assistant professor of pulmonary medicine at Emory University School of Medicine, and lead author of the study.

Traffic-related pollutants are known to be associated with asthma severity, but to what extent they affect airway inflammation and lung volume in both asthmatic and nonasthmatic children was unknown.

"Major cities along the northern and southern US borders often have high levels of vehicular traffic flows, especially at the border crossing points," says Dr. Holguin. "Vehicular traffic emissions from the high density of border crossing traffic may be negatively affecting the health of populations who live in nearby areas."

To investigate how specific traffic-related pollutants affected children's lung function and respiratory symptoms, the researchers recruited 200 age- and sex-matched asthmatic and non-asthmatic schoolchildren from ages six to 12. Over the course of a year, they measured road and traffic density and traffic-associated pollutants near the children's homes and schools, and evaluated each child's lung function and respiratory symptoms consecutively for four months.

Asthmatic children, but not children without asthma, were affected by living in homes in areas with high road density. They had higher levels of exhaled NO, as well as reductions in both lung volume and airflow. Living within 50 meters of high density road areas increased the chances of respiratory symptoms in asthmatic children by more than 50 percent.

"These results may have implications for asthmatic children residing in these conditions, especially among those who may not be adequately controlled with medications, for they may be more susceptible to vehicular emissions," says Dr. Holguin.

While increased traffic and road density near schools also indicated respiratory effects in both asthmatic and nonasthmatic children, the data did not attain statistical significance in this study.

Dr. Holguin notes, "This finding could have significant public health policy implications because a significant proportion of schools in many countries are located in close proximity to major roads."

This is the first study of its kind to evaluate traffic-related emissions exposure in a large group of children with and without asthma over an entire year. The findings support and add to previous studies that have looked at the effects of traffic emissions on children, but it may have been underpowered to detect significant associations between respiratory outcomes and specific pollutants.

"These results are significant because they quantitatively demonstrate that closer exposure to roads lead to chronic airway inflammation and reductions in lung function," says Dr. Holguin. "This study points the way for future research to determine what preventive measures may be taken to reduce exposure and or the health effects of vehicular emissions in susceptible children."

Piedmont Fayette Hospital Hosts Community Healthy Heart Fair

February is Heart Health Month

Cardiovascular disease (CVD), which is the leading cause of death in the state, accounted for 34 percent of deaths in Georgia in 2005. Georgia's CVD rate was 13 percent higher than the national rate according to Georgia's Department of Human Resources (2004). February is Heart Health Month, and to educate the community on the risks of heart disease, Piedmont Fayette Hospital will host a free Healthy Heart Fair on Saturday, Feb. 2, from 9 a.m. to 2 p.m. in the hospital's west entrance.

"Piedmont Fayette Hospital is urging the community to get the facts on one of Georgia's leading killers--heart disease," said Darrell Cutts, president and CEO at Piedmont Fayette Hospital. "The Healthy Heart Fair is the ideal time for residents to receive free health screenings and learn how to lower their risk of the chronic disease."

The Healthy Heart Fair will offer a variety of health screenings, including blood pressure, glucose, cholesterol, ABI, body mass index and EKG. Free educational materials covering all aspects of a healthy heart also will be provided.

Hospital staff from all areas including the Fitness Center will be on hand to educate attendees on disease prevention, rehabilitation of injuries and maintenance of optimal health and fitness wellness

"Physicians will also be available to answer heart health questions," said George Leslie, director of cardiopulmonary services at Piedmont Fayette Hospital. "The ultimate goal is to alert residents about the importance of getting regular physical activity, eating healthy, quitting smoking and undergoing routine check-ups to lower their risk of heart disease and other chronic diseases."

Throughout the year, PFH also offers smoking cessation classes to help smokers quit their addiction. Led by a Piedmont Fayette Hospital respiratory staff member, who is an American Lung Association trained facilitator, the class promises to be both informative and enlightening. Smoking cessation classes will be held throughout the year beginning in January. For more information on the class, call 770-719-6258.

PFH offers a range of advanced, comprehensive diagnostic and rehabilitative cardiology services, including echocardiograms, electrocardiograms (EKG), holter and event monitoring, cardiac monitoring, stress-testing and cardiac rehabilitation. The cardiology care team includes physicians, nurses, cath lab technologists, therapists, nutritionists and other healthcare professionals and offers innovative heart care - in and out of the hospital. For a physician referral, call 1-866-900-4321, or for more information about Piedmont Fayette Hospital’s cardiology services, please visit http://www.fayettehospital.org/.

PIEDMONT PHYSICIANS AT TATE COMMUNITY CLINIC

The Piedmont Physicians at Tate Community Clinic welcomes Michael A. Suarez, M.D., to its healthcare team.

Dr. Suarez is board-certified in family medicine and has been in practice for over eight years. He earned his medical degree from The Ohio State University College of Medicine in Columbus, Ohio and completed his residency training in family medicine from the University of Florida North Broward Hospital District in Coral Springs, Florida.

Following completion of his residency, Dr. Suarez joined the Watson Clinic in Lakeland, Florida. After two years in Lakeland, he returned to Ohio where he joined Memorial Physicians, Inc. in Marysville. Prior to joining the Piedmont Physicians at Tate Community Clinic, he treated patients at the Doctor’s Office in Hilliard, Ohio.

“We are pleased to welcome such an exceptional physician to the Piedmont family," said Berney Crane, CEO of Piedmont Medical Care Corporation, the administrative parent corporation of the Piedmont Physicians Group. "Dr. Suarez will provide excellent care to our patients.”

Dr. Suarez accepts most major insurance plans and is available for immediate appointments. Office hours are Monday through Thursday, 8 a.m. to 5 p.m. and Fridays, 8 a.m. to noon. The office is located at 89 Clinic Road, in Tate, Ga. For an appointment, call 770-737-3333.

Wednesday, January 16, 2008

FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease

Drug currently approved for use in treating some forms of multiple sclerosis

The U.S. Food and Drug Administration has approved Tysabri (natalizumab) for the treatment of moderate-to-severe Crohn's disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies. Crohn's disease patients using the drug must be enrolled in a special restricted distribution program called the Crohn's Disease–Tysabri Outreach Unified Commitment to Health (CD TOUCH) Prescribing Program.

The approval is consistent with an agency advisory committee recommendation to approve Tysabri for use in Crohn's patients. Tysabri was approved by the FDA in June 2006 to treat relapsing forms of multiple sclerosis.

Crohn's disease is a chronic, inflammatory bowel disease that affects both men and women. There is no cure. Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. The disease also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs. Its cause is unknown. There are more than 1 million people with Crohn's disease worldwide.
"The addition of Tysabri to the treatment options for sufferers of Crohn's disease is important, but one that carries serious risks," said Daniel Shames, deputy director of the Office for Drug Evaluation III and director of the Division of Gastroenterology Products for the Center for Drug Evaluation and Research. "Health care providers must carefully monitor patients for these risks. The CD-TOUCH Prescribing Program will aid FDA in monitoring this drug through its life cycle."

Tysabri carries a boxed warning for progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection that affects the brain and can lead to death or severe disability.
Other serious adverse events that have occurred in Tysabri-treated patients include hypersensitivity reactions, such as anaphylaxis and liver injury. Serious opportunistic and other atypical infections have been observed in patients receiving immunosuppressants while on Tysabri, and Tysabri should generally not be used in patients receiving immunosuppressants. Serious herpes infections have also been observed. Common side effects include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.

Because of these risks, patients, prescribers, pharmacies, and infusion centers must all be enrolled in CD-TOUCH and agree to comply with the company's strict monitoring guidelines. Additionally, they must participate in an extensive educational program designed to inform people about the risks of Tysabri treatment. Tysabri is administered intravenously by trained professionals at infusion centers.


Under CD-TOUCH, health care providers evaluate Crohn's disease patients after three months of treatment to determine if they have improved on Tysabri. If not, patients should discontinue treatment. People who are taking steroids for Crohn's disease should begin tapering steroid doses while on Tysabri. Treatment should be discontinued if steroids cannot be fully tapered within six months.

Tysabri is manufactured by Biogen Idec of Cambridge, Massachusetts and Elan of Dublin, Ireland. Both companies have agreed to conduct long-term surveillance for safety, including monitoring and expedited reporting of PML infections, other serious opportunistic infections, malignancies, and deaths in people treated with Tysabri.

For more information on Crohn's Disease, visit:

Crohn's Disease–National Institute of Diabetes and Digestive and Kidney Diseases www.digestive.niddk.nih.gov/ddiseases/pubs/crohns/index.htm

FDA Issues Documents on the Safety of Food from Animal Clones

Agency Concludes that Meat and Milk from Clones of Cattle, Swine, and Goats, and the Offspring of All Clones, are as Safe to Eat as Food from Conventionally Bred Animals

After years of detailed study and analysis, the Food and Drug Administration has concluded that meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. There was insufficient information for the agency to reach a conclusion on the safety of food from clones of other animal species, such as sheep.

FDA today issued three documents on animal cloning outlining the agency's regulatory approach – a risk assessment; a risk management plan; and guidance for industry.

The documents were originally released in draft form in December 2006. Since that time, the risk assessment has been updated to include new scientific information. That new information reinforces the food safety conclusions of the drafts.

In 2001, U.S. producers agreed to refrain from introducing meat or milk from clones or their progeny into the food supply until FDA could further evaluate the issue. The U.S. Department of Agriculture will convene stakeholders to discuss efforts to provide a smooth and orderly market transition, as industry determines next steps with respect to the existing voluntary moratorium.

The agency is not requiring labeling or any other additional measures for food from cattle, swine, and goat clones, or their offspring because food derived from these sources is no different from food derived from conventionally bred animals. Should a producer express a desire for voluntary labeling (e.g., "this product is clone-free"), it will be considered on a case-by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading.

Because clones would be used for breeding, they would not be expected to enter the food supply in any significant number. Instead, their sexually reproduced offspring would be used for producing meat and milk for the marketplace. At this time, the agency continues to recommend that food from clones of species other than cattle, swine and goat (e.g., sheep) not be introduced into the food supply.

An animal clone is a genetic copy of a donor animal, similar to an identical twin, but born at a different time. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence. Due to their cost and rarity, clones are intended to be used as elite breeding animals to introduce desirable traits into herds more rapidly than would be possible using conventional breeding.

Risk assessment

The risk assessment finds that meat and milk from clones of cattle, swine, and goats, and food from the sexually reproduced offspring of clones, are as safe to eat as food from conventionally bred animals. The science-based conclusions agree with those of the National Academy of Sciences, released in a 2002 report. The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health. They found the methods FDA used to evaluate the data were adequate and agreed with the conclusions set out in the document.
The risk assessment presents an overview of assisted reproductive technologies widely used in animal agriculture, the extensive scientific information available on the health of animal clones and their sexually reproduced offspring, and an assessment of whether food from clones or their sexually reproduced offspring could pose food consumption risks different from the risks posed by food from conventionally bred animals. These conclusions were first presented in draft documents over a year ago. Since then, the agency has updated the risk assessment with data that became available, as well as taking into account comments from the public comment period.
"After reviewing additional data and the public comments in the intervening year since the release of our draft documents on cloning, we conclude that meat and milk from cattle, swine, and goat clones are as safe as food we eat every day," said Stephen F. Sundlof, D.V.M., Ph.D., director of FDA's Center for Food Safety and Applied Nutrition. "Our additional review strengthens our conclusions on food safety."

Risk management plan

The risk management plan outlines measures that FDA has taken to address the risks that cloning poses to animals involved in the cloning process. These risks all have been observed in other assisted reproductive technologies currently used in common agricultural practices in the United States. FDA is currently working with scientific and professional societies with expertise in animal health and reproduction to develop standards of care for animals involved in the cloning process. Although the agency is not charged with addressing ethical issues related to animal cloning for agricultural purposes, FDA plans to continue to provide scientific expertise to interested parties working on these issues.

Guidance for industry

The guidance for industry addresses the use of food and feed products derived from clones and their offspring. It is directed at clone producers, livestock breeders, and farmers and ranchers purchasing clones, and provides the agency's current thinking on use of clones and their offspring in human food or animal feed.

In the guidance, FDA does not recommend any special measures relating to the use of products from cattle, swine, or goat clones as human food or animal feed. Because insufficient information was available on clones from other species, e.g., sheep clones, to make a decision on the food consumption risks, the guidance recommends that food products from clones of other species continue to be excluded from the human food supply. The guidance states that food products from the offspring of clones from any species traditionally consumed for food are suitable to enter the food and feed supply.

For more information, visit http://www.fda.gov/cvm/cloning.htm.