Piedmont Mountainside Hopsital Welcomes New Physicians

Piedmont Mountainside Hospital has expanded its medical staff with the addition of several new physicians in the fields of cardiology, internal medicine/family practice, urology and neurology. These physicians joined the medical staff in the spring of 2009.

“At Piedmont Mountainside Hospital, we strive to attract physicians with the highest credentials, ensuring the best quality of care for our patients,” said Mike Robertson, president and CEO of Piedmont Mountainside Hospital. “We're thrilled to have each of these new physicians on our team, and we're excited about the work they'll do for the north Georgia area.”

Piedmont Mountainside Hospital welcomes John Hurst Jr., M.D., Shailesh Malla, M.D., and Sara Mobasseri, M.D., to its cardiology team. These three physicians are all members of Piedmont Heart Institute, the first integrated cardiovascular healthcare delivery program affiliated with a community health system in greater Atlanta. Dr. John Hurst Jr. received his undergraduate degree from Emory University in Atlanta and his medical training from the Medical College of Georgia in Augusta. Dr. Sara Mobasseri received her undergraduate training at Washington University in St. Louis, Mo., before attending medical school at the Medical College of Ohio in Toledo. Dr. Shailesh Malla received his medical training from Tribhuvan University, the premier Medical School of Nepal, prior to completing his residency in internal medicine at Jacobi Medical Center in New York.

Piedmont Mountainside Hospital welcomes Khadeja Johnson, M.D., Jayuasri Mallavarapu, M.D., Nicole Nunga, M.D., and Sanja Serrao, M.D., to its internal medicine team. Dr. Johnson received her medical degree from Mount Sinai School of Medicine in New York and completed her internship and residency at Morehouse School of Medicine in Atlanta. Dr. Mallavarupu received her medical degree from Osmania Medical College in India and completed her internship and residency at Floyd Medical Center in Rome, Ga. Dr. Nunga received her medical degree from Freie Universitat Berlin in Germany and completed her internship and residency at Morehouse School of Medicine. Dr. Serrao received his medical training at Grant Medical College in India and completed his internship and residency at the University of Connecticut, School of Medicine.

Piedmont Mountainside Hospital also welcomes Charles Kaplan, M.D., to its urology team. Dr. Kaplan received his medical degree from Emory University School of Medicine before completing his internship at New York Presbyterian Hospital, Weill Cornell Center. He then went on to complete his residency at Georgetown University School of Medicine in Washington DC.

Finally, Piedmont Mountainside Hospital welcomes Faiz Niaz, M.D., to its neurology team. Dr. Niaz received his medical degree from Dow Medical College in Pakistan and completed his internship and residency at Vanderbilt University Medical Center in Tennessee.

Piedmont Mountainside Hospital will continue to raise its level of quality care by consistently adding top-level physicians. For more information about Piedmont Mountainside Hospital or to find a physician in your area, please visit piedmontmountainsidehospital.org.

Hearsay: How to remove a tick

A School Nurse has written the info below -- good enough to share -- And it really works!!

I had a pediatrician tell me what she believes is the best way to remove a tick.. This is great, because it works in those places where it's some times difficult to get to with tweezers: between toes, in the middle of a head full of dark hair, etc.

Apply a glob of liquid soap to a cotton ball. Cover the tick with the soap-soaked cotton ball and swab it for a few seconds (15-20), the tick will come out on its own and be stuck to the cotton ball when you lift it away. This technique has worked every time I've used it (and that was frequently), and it's much less traumatic for the patient and easier for me.

Unless someone is allergic to soap, I can't see that this would be damaging in any way.

I even had my doctor's wife call me for advice because she had one stuck to her back and she couldn't reach it with tweezers. She used this method and immediately called me back to say, "It worked!"

Note: We received the above via email and have not tried it. According to all we've read, the only safe way to remove a tick is with tweezers, etc. If you try this and it works, let us know!

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Obama Administration Calls on Nation to Begin Planning and Preparing for Fall Flu Season & the New H1N1 Virus

The Obama Administration sent a strong message to the nation today that it is time to start planning and preparing for the fall flu season and the ongoing H1N1 flu outbreak and that the federal government is prepared to commit resources, training, and new tools to help state and
local governments and America's families get ready.

White House Homeland Security Advisor John Brennan, Secretary of Health and Human Services Kathleen Sebelius, Secretary of Homeland Security Janet Napolitano, Secretary of Education Arne Duncan joined with delegations from 54 states, tribes and territories today at the H1N1 Influenza Preparedness Summit at the National Institutes of Health in Bethesda, Md., to kick-off the government's nation-wide fall flu preparedness efforts.

"The President and the administration are actively engaged in mitigating the effects of the H1N1 flu virus and developing a national response framework and action plan that builds on the efforts and lessons learned from this spring's initial onset to prepare for the possibility of a
more serious fall outbreak of the virus," said White House Homeland Security Advisor Brennan in his address to summit participants.

"Over the course of coming weeks and months, we will move aggressively to prepare the nation for the possibility of a more severe outbreak of the H1N1 virus," said HHS Secretary Sebelius. "We ask the American people to become actively engaged with their own preparation and
prevention. It's a responsibility we all share."

"The federal government is working together with its federal, state, local and tribal partners to develop a nation-wide plan to combat the H1N1 flu that incorporates the lessons we learned this spring," said Homeland Security Secretary Napolitano. "The H1N1 Summit will allow us to continue this aggressive preparation for all possible H1N1 virus outbreak scenarios to ensure that we are doing everything possible to keep our country safe and healthy."

"Effectively dealing with a potential H1N1 outbreak requires all of us -- parents, educators, health providers, and local, state and federal governments -- working together on our emergency management plan," said Education Secretary Duncan. "Today's Flu Summit is an important step in that direction. Our primary goals at the Department of Education are the health and well being of students, faculty and staff, and ensuring that, in the event of any school closures, the learning process will continue."

Maryland Governor Martin O'Malley moderated a Governors panel with participation via videolink from Governor Jim Douglas of Vermont, Governor Jim Doyle of Wisconsin, Governor Mark Parkinson of Kansas, Governor John Baldacci of Maine and Governor Jodi Rell of Connecticut.

"When responding to a national pandemic or a national recession, the basic principles of smart government remain the same -- to increase efficiency, openness, and transparency in everything we do. Today's summit illustrates our collective commitment to that goal," said Maryland Governor Martin O'Malley. "The experience in the spring taught us that while earlier pandemic flu planning efforts were effective, there are also areas for improvement. Effective response requires accurate and timely information that is as close to real time as possible. We share the commitment of the Obama Administration to constantly monitor, evaluate and improve these processes as we continue to lead the world in emergency preparedness."

Throughout the one-day summit, Administration officials laid out specific ways that states and local governments could start their planning and preparation efforts and announced new programs and resources to help state and local governments, the medical community and every day America prepare for H1N1 and the fall flu season.

First, HHS will make available preparedness grants worth a total of $350 million. These grants were funded by Congress in the latest supplemental appropriations bill and they will give state and local public health offices and health care systems valuable resources to step up their
preparedness efforts.

Second, the federal government will centralize communications about H1N1 and seasonal flu on the federal government's new Web site www.flu.gov. This one-stop comprehensive site brings together flu-related information from across HHS and other federal agencies. The expanded site builds on the pandemic planning information long presented on www.pandemicflu.gov, and incorporates information about the novel H1N1 flu as well as the seasonal flu.

Finally, HHS is launching a new PSA campaign contest to encourage more Americans to get involved in the nation's flu preparedness efforts by making a 15-second or 30-second PSA. Officials at the summit stressed the idea of "shared responsibility" when it comes to combating the flu and the goal of the new HHS PSA campaign contest is to tap into the nation's creativity to help educate Americans about how to plan for and prevent the spread of H1NI influenza. HHS will evaluate submissions and will present the best PSAs back to the public so everyone can vote on their favorite submission. The winning PSA will receive $2,500 in cash and will appear on national television. Contest details as well more information about the larger effort to plan and prepare for the flu season are available at www.flu.gov.

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Governor Appoints Jewel Norman Mental Health Ombudsman

Governor Sonny Perdue announced today that he has appointed Jewel Norman as the State Disability Services Ombudsman. Norman will assume the position on July 16.

“Along with creating a stand alone agency for developmental disabilities, the appointment of Jewel Norman as the mental health ombudsman is another step in improving the state’s care and delivery of services to the mental health community,” said Governor Perdue. “Ms. Norman has a wealth of public and private experience managing human services.”

The mental health ombudsman is a five year appointment. In January, the Governor organized a committee to nominate candidates for ombudsman. Member of the committee included Mary Burns, Nora Haynes, Tommy Hills, Vernon Keenan, Sharon McDaniel, Don Meck and Gwen Skinner.

“I look forward to working with the advocacy and provider community to promote system-wide improvements in mental health, developmental disabilities and addictive disease,” said Norman.
The ombudsman will investigate and make recommendations to the department and other agencies, establish a uniform state-wide complaint process, collect and record data relating to complaints with regard to service providers, recommend law and policy changes, and make a biennial written report documenting types of complaints reported by consumers.

“This is a great day for people with mental illness and co-occurring disorders and their families,” said Nora Haynes, President of the Georgia chapter of the National Alliance on Mental Illness.

Jewel Norman has served as Chief Operating Officer and Chief Executive Officer of a large private for profit residential treatment facility. She has also served as a regional vice president of a psychiatric hospital corporation and served as interim CEO for a number of larger comprehensive psychiatric hospitals. Norman received her undergraduate degree from the University of Mary Washington and master’s degree from the University of Virginia.
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Rollins School of Public Health Names New Chair of Biostatistics and Bioinformatics

Lance Waller, PhD, has been named Rollins Professor and Chair of the Department of Biostatistics and Bioinformatics at Emory University's Rollins School of Public Health. His appointment was effective July 1.

Waller will also serve as associate director of biostatistics and bioinformatics in the Emory Center for Comprehensive Informatics, a multi-disciplinary center that supports translational, clinical or deep integrative studies combining biostatistics and high-performance computing techniques.

Waller joined Emory in 1998 as an associate professor of biostatistics. He was promoted to a professor of biostatistics in 2003 and was elected the same year to the Fellowship in the American Statistical Association. Waller was recently tapped as chair of the department after an extensive national search.

"Dr. Waller is taking the helm of the biostatistics and bioinformatics department at a very exciting time," says James W. Curran, MD, MPH, dean of the Rollins School of Public Health. "Emory researchers in a range of disciplines, including predictive health, oncology and HIV/AIDS, are increasingly turning to biostatistics to aid their bioscience research efforts. Dr. Waller's expertise will be an asset to the department and his colleagues."

Waller's research involves the assessment of spatial clustering of disease, linking spatial statistics and geographic information systems, statistical assessments of environmental justice, and hierarchical methods for modeling small-area health statistics. His recent analyses have included spatial point process methods in alcohol epidemiology and conservation biology (sea turtle nesting patterns), and hierarchical models in disease ecology.

“I look forward to building on the department’s strong base in biostatistical research, training and collaboration," says Waller. "The most effective programs in biostatistics grow and adapt in concert with new methods of measurement and the new research possibilities enabled by them. I’m especially excited about new opportunities in the analysis of high-dimensional data, which link information from multiple sources in a variety of applications from across the health sciences. Making sense of these complex data in accurate, reliable, and interpretable ways is our primary goal."

Waller has authored or coauthored more than 100 articles and one book. His research is actively supported by seven federal grants, including four National Institutes of Health (NIH) grants on which he currently serves as principal investigator. In addition, Waller serves on numerous national advisory committees and has actively taught and mentored graduate and professional students during his tenure at Emory. Waller is also an alumnus of the Emory Woodruff Leadership Academy.

Waller earned his master's of science and doctoral degree in operations research from Cornell University. Before coming to Emory, he was an associate professor of biostatistics at the University of Minnesota and the University of Alabama at Birmingham.

Emory's biostatistics and bioinformatics faculty collaborate with researchers in a variety of disciplines, developing and applying statistical methodology in search of solutions to medical and public health problems. Specific research projects include a five-year, NIH-funded grant to develop powerful computer modeling techniques to analyze and respond to infectious disease outbreaks; efforts to apply biostatistical methods to the analysis of genetic data to further understanding of complex disorders such as Parkinson’s disease and schizophrenia; and the development of statistical methods to analyze the distribution of the burdens of environmental hazards between different socioeconomic groups.

The Rollins School of Public Health enrolls over 900 graduate students in masters' and doctoral programs, has more than 5,000 alumni, and employs 180 full-time faculty who work throughout Georgia, the United States, and in more than 100 countries around the globe. The Department of Biostatistics and Bioinformatics consists of more than 30 full-time and 20 adjunct faculty members.

To learn more about the Rollins School of Public Health, visit www.sph.emory.edu, and to learn more about the Emory Center for Comprehensive Informatics, visit http://cci.emory.edu/cms/index.html.
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Obesity Among U.S. Adults Continues to Rise

Obesity Prevalence 25 Percent or Higher in 32 States

The proportion of U.S. adults who are obese increased to 26.1 percent in 2008 compared to 25.6 percent in 2007. The data come from CDC's Behavioral Risk Factor Surveillance System (BRFSS), a state-based phone survey that collects health information from adults aged 18 and over.

In six states - Alabama, Mississippi, Oklahoma, South Carolina, Tennessee and West Virginia - adult obesity prevalence was 30 percent or more. Thirty-two states, including those six, had obesity prevalence of 25 percent or more. Only one state, Colorado, had a prevalence of obesity less than 20 percent. But no state showed a significant decrease in obesity prevalence from 2007 to 2008.

More than 400,000 U.S. adults were surveyed in the 2008 BRFSS, which is the world's largest telephone health survey. To assess obesity prevalence, survey respondents are asked to provide their height and weight, which is used to calculate their body mass index (BMI). A person is considered obese if they have a BMI of 30 or above.

"Obesity is a major risk factor for many chronic diseases such as heart disease and diabetes. As obesity increases among all age groups, we are seeing chronic diseases in much younger adults compared to a few decades ago," said Dr. William Dietz, director, CDC's Division of Nutrition, Physical Activity and Obesity.

"For example, we now see young adults who suffer from heart disease risk factors and other conditions such as type 2 diabetes that were unheard of in the past."

The 2008 BRFSS obesity data indicate that none of the 50 states or the District of Columbia has achieved the Healthy People 2010 goal of reducing obesity prevalence to 15 percent or less.

"The latest BRFSS survey data show that the obesity problem in this country is getting worse," said Liping Pan, CDC epidemiologist and lead author of the 2008 BRFSS obesity map analysis. "If this trend continues we will likely see increases in health care costs for obesity related diseases."

For more information on obesity trends, including an animated map, visit
www.cdc.gov/obesity/data/trends.html.
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Isakson, Chambliss Praise Albany Non-Profit Founder as CNN Hero

U.S. Senators Johnny Isakson, R-Ga., and Saxby Chambliss, R-Ga., today praised the work of Pamela Green Jackson, founder and CEO of The Youth Becoming Healthy Project, whose work has led to her selection as a CNN ‘Hero of the Week.’

Jackson will appear on CNN’s Larry King Live and American Morning this week to discuss her accomplishments with The Youth Becoming Healthy Project.

Jackson founded the non-profit organization in February 2004 in memory of Bernard Green, her only brother, who lost his battle to complications of obesity-related illnesses on February 11, 2004. Since that time, The Youth Becoming Healthy Project has worked with countless numbers of students in Dougherty County’s middle schools by placing fitness centers, staff and wellness programs in each school to help combat childhood obesity. Jackson has also expanded her work to include elementary schools.

“Not only does The Youth Becoming Healthy Project work directly with students and schools to provide fitness and nutrition education and healthier menu choices, but Pamela Green Jackson serves as an inspiration to the community as she took a personal tragedy and turned it into a victory for her community,” said Isakson.

“I applaud Pamela Green Jackson for her tremendous work in the Albany community,” said Chambliss. “The obesity rate among children has dramatically increased over the past 20 years and these nutrition education and wellness programs are an important step in teaching our young students how to live healthy lifestyles.”

CNN Heroes, now in its third year, recognizes individuals around the world who are making a difference in their communities and beyond. Thousands of individuals are nominated by people from around the world in various categories. Jackson was chosen from a pool of viewer-submitted nominees and will be featured on Larry King Live this Thursday, July 9, at 9:00 p.m. and on CNN Heroes beginning Friday, July 10, 2009, on CNN, CNN International and CNN En Espanol.
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FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene

The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses.

The agency is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed.

In addition, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action.

“Physicians need to be aware of the risk of overdose when prescribing these drugs. They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug’s label,” said Janet Woodcock, M.D, director of the FDA’s Center for Drug Evaluation and Research. “Prescribers and patients should be aware of propoxyphene’s potential risks when used at doses higher than those recommended. Therefore, the FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy.”

To further evaluate the safety of propoxyphene, the FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.

Propoxyphene manufacturers are required to submit the requested safety labeling changes to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or if the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes. At the end of these discussions, the FDA may issue an order directing the labeling changes as deemed appropriate to address the new safety information.

Also today, the FDA denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene. The agency said in its response that despite the FDA’s serious concerns about propoxyphene, the benefits of using the medication for pain relief at recommended doses outweighs the safety risks at this time. The FDA also noted that it plans to further evaluate the safety of propoxyphene and will take additional regulatory action if necessary. Details of this decision can be found at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm170268.htm.

Propoxyphene has been on the market since 1957. It is a widely prescribed member of a group of drugs known as opioids and is used as a treatment for mild to moderate pain.

The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting.

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CDC Launches New Environmental Public Health Tracking Network

The Centers for Disease Control and Prevention announced today the launch of the Web-based Environmental Public Health Tracking Network, a surveillance tool that scientists, health professionals, and -- for the first time -- members of the public can use to track environmental exposures and chronic health conditions.

"The ability to examine many data sets together for the first time has already resulted in faster responses to environmental health issues. We believe the Tracking Network holds the potential to shed new light on some of our biggest environmental health questions," said Howard Frumkin, M.D., M.P.H., DrPh., director, of CDC's National Center for Environmental Health.

The web-based tool unites vital environmental information from across the country, including air and water pollutants and information for some chronic conditions, including asthma, cancer, childhood lead poisoning and heart disease into one resource.

While scientists know exposures such as air particle pollution and lead contribute to illnesses, many environmental and health connections remain unproven since detailed health and environmental data existed in separate silos until now.

"The Tracking Network is the foundation we need to make better environmental health decisions and help prevent chronic illnesses, such as asthma, cancer, and heart disease," said Michael McGeehin, Ph.D., director, Division of Environmental Hazard and Health Effects of CDC's National Center for Environmental Health.

CDC funds projects in California, Connecticut, Florida, Maine, Maryland, Massachusetts, Missouri, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Utah, Washington, Wisconsin, and New York City.

To date, their projects have led to 73 public health actions to control potential illnesses from environmental exposures. For example, the Utah Department of Health received a call from a citizen concerned about cases of cancer in his neighborhood. In the past, a similar call would have prompted a study that would have taken up to a year to complete, with most of that time spent waiting for data. In less than a day, the Utah Tracking Program was able to let this resident know that the likelihood of cancer in his area was no greater than in the state as a whole.

Massachusetts ranks third in the United States for prevalence of asthma. When Massachusetts Tracking staff conducted asthma surveillance and indoor quality assessments in schools, a significant association between mold/moisture and the prevalence of asthma was found. Based on tracking data, Massachusetts staff are working with school officials to correct mold/moisture problems and to enact policy changes for reducing mold and moisture in schools.

In March 2009, CDC received additional funding from Congress to expand environmental public health tracking to five more locations. Awards will be made and announced later this summer. Over time, CDC hopes to expand the Tracking Network across all 50 states, and track additional environmental hazards and health conditions to build a more complete picture of environmental public health.

CDC's Tracking Network is the result of collaboration with 17 local and state health departments; federal partners, including the National Aeronautics and Space Administration, the National Cancer Institute, the U.S. Environmental Protection Agency and the U.S. Geological Survey; and organizations including the American Public Health Association, Association of State and Territorial Health Officials, Council of State and Territorial Epidemiologists, National Association of County and City Health Officials, National Environmental Health Association, National Association of Health Data Organizations and the National Association for Public Health Statistics and Information Systems.

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FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer

The U.S. Food and Drug Administration has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.

Patients with cancer often receive maintenance therapy to prevent the disease from progressing after their tumor has shrunk or the disease has stabilized in response to chemotherapy. Alimta disrupts metabolic processes that are dependent on the B-vitamin folate, a necessary ingredient for cell replication.

“This drug represents a new approach in the treatment of advanced non-small cell lung cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four-to-six chemotherapy cycles. This study demonstrates an advantage in overall survival in certain patients who received Alimta for maintenance therapy.”

Non-small cell lung cancer has several subtypes, including squamous cell, large cell, adenocarcinoma and mixed histology cancers. In a 600-patient clinical trial, people with predominantly squamous cell cancer did not benefit from Alimta. But those with other subtypes of non-small lung cancer survived an average 15.5 months following treatment compared with 10.3 months for patients who received an inactive substance (placebo). All patients in the study received standard medical care.

Reported adverse events included damage to blood cells, fatigue, nausea, loss of appetite, tingling or numbness in the hands and feet, and skin rash.

Alimta initially was approved in 2004 for the treatment of patients with mesothelioma, a cancer frequently related to asbestos exposure. The drug was later approved for the treatment of patients with non-small cell lung cancer whose disease worsened on prior chemotherapy drugs and also as an initial therapy for advanced non-small cell lung cancer.

Alimta is manufactured by Eli Lilly & Co. of Indianapolis.

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Pain Medicine Experts Recommend Safe and Responsible Use of Acetaminophen

/PRNewswire/ -- In response to the advisory committee's recommendations to the U.S. Food and Drug Administration (FDA) to put new restrictions on acetaminophen this week, physician leaders from the American Academy of Pain Medicine (AAPM), have released the following statement:

The American Academy of Pain Medicine (AAPM), which represents the
medical specialty of Pain Medicine, supports the safe and responsible
use of acetaminophen both in over-the-counter and prescription
medicines. While there are risks associated with the misuse of
acetaminophen, the benefits to patients suffering from both
short-term and chronic pain are significant.

The misuse and abuse of both over-the-counter and prescription
medicines are significant social and medical problems that must be
addressed responsibly. But, the under-treatment of pain is also a
longstanding and significant medical and social problem that also
must be addressed responsibly.

AAPM recognizes that analgesics that combine acetaminophen and an
opioid do pose additional risk for patients with pain conditions
that require doses of the opioid component for sufficient pain relief
that exceed safe doses of the acetaminophen component.

AAPM supports measures that reduce the risk of misuse and abuse of
medications without deterring access to appropriate pain care for
legitimate patients and the need for physicians to adhere to
responsible analgesic prescribing practices. The Academy will
continue to work towards these goals through advocacy, research,
promotion of best clinical practices, and continuing medical
education.

AAPM, founded in 1983, is the recognized authority on the evaluation
and care of patients with pain. It is a professional community of
physicians with a sustained interest in pain disorders and their
management, with a background in related specialties such as
anesthesiology, internal medicine, neurology, neurosurgery,
orthopedic surgery, physiatry, family practice, and psychiatry.

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FDA Approves Multaq to Treat Heart Rhythm Disorder

The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.

Multaq may cause critical adverse reactions, including death, in patients with recent severe heart failure. The drug’s label will contain a boxed warning, the FDA’s strongest warning, cautioning that the drug should not be used in severe heart failure patients.

“Multaq represents a therapeutic innovation for treatment of the heart rhythm disorder of atrial fibrillation,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

In a multinational clinical trial with more than 4,600 patients, Multaq reduced cardiovascular hospitalization or death from any cause by 24 percent, when compared with an inactive pill (placebo). Most of that effect represents reduced hospitalizations, especially hospitalizations related to atrial fibrillation. Atrial fibrillation and atrial flutter cause the heart to beat abnormally fast and sometimes prevent blood from being properly pumped out of the heart.

The most common adverse reactions reported by patients in clinical trials were diarrhea, nausea, vomiting, fatigue and loss of strength.

Multaq is manufactured by Paris-based sanofi-aventis.

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Nanotechnology may increase longevity of dental fillings

ooth-colored fillings may be more attractive than silver ones, but the bonds between the white filling and the tooth quickly age and degrade. A Medical College of Georgia researcher hopes a new nanotechnology technique will extend the fillings' longevity.

"Dentin adhesives bond well initially, but then the hybrid layer between the adhesive and the dentin begins to break down in as little as one year," says Dr. Franklin Tay, associate professor of endodontics in the MCG School of Dentistry. "When that happens, the restoration will eventually fail and come off the tooth."

Half of all tooth-colored restorations, which are made of composite resin, fail within 10 years, and about 60 percent of all operative dentistry involves replacing them, according to research in the Journal of the American Dental Association.

"Our adhesives are not as good as we thought they were, and that causes problems for the bonds," Dr. Tay says.

To make a bond, a dentist etches away some of the dentin's minerals with phosphoric acid to expose a network of collagen, known as the hybrid layer. Acid-etching is like priming a wall before it's painted; it prepares the tooth for application of an adhesive to the hybrid layer so that the resin can latch on to the collagen network. Unfortunately, the imperfect adhesives leave spaces inside the collagen that are not properly infiltrated with resin, leading to the bonds' failure.

Dr. Tay is trying to prevent the aging and degradation of resin-dentin bonding by feeding minerals back into the collagen network. With a two year, $252,497 grant from the National Institute of Dental & Craniofacial Research, he will investigate guided tissue remineralization, a new nanotechnology process of growing extremely small, mineral-rich crystals and guiding them into the demineralized gaps between collagen fibers.

His idea came from examining how crystals form in nature. "Eggshells and abalone [sea snail] shells are very strong and intriguing," Dr. Tay says. "We're trying to mimic nature, and we're learning a lot from observing how small animals make their shells."

The crystals, called hydroxyapatite, bond when proteins and minerals interact. Dr. Tay will use calcium phosphate, a mineral that's the primary component of dentin, enamel and bone, and two protein analogs also found in dentin so he can mimic nature while controlling the size of each crystal.

Crystal size is the real challenge, Dr. Tay says. Most crystals are grown from one small crystal into a larger, homogeneous one that is far too big to penetrate the spaces within the collagen network. Instead, Dr. Tay will fit the crystal into the space it needs to fill. "When crystals are formed, they don't have a definite shape, so they are easily guided into the nooks and crannies of the collagen matrix," he says.

In theory, the crystals should lock the minerals into the hybrid layer and prevent it from degrading. If Dr. Tay's concept of guided tissue remineralization works, he will create a delivery system to apply the crystals to the hybrid layer after the acid-etching process.

"Instead of dentists replacing the teeth with failed bonds, we're hoping that using these crystals during the bond-making process will provide the strength to save the bonds," Dr. Tay says. "Our end goal is that this material will repair a cavity on its own so that dentists don't have to fill the tooth."

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FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (buproprion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Similar information on mental health events will be required for buproprion marketed as the antidepressant Wellbutrin and for generic versions of buproprion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

Woodcock said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes.

The FDA’s request for the additional warnings is based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.

Neither Chantix nor Zyban contain nicotine and some of these symptoms may be a response to nicotine withdrawal. People who stop smoking may experience symptoms such as depression, anxiety, irritability, restlessness, and sleep disturbances. However, some patients who were using these products experienced the reported adverse events while they were still smoking.
In addition to the Boxed Warning, the FDA also is requesting more information in the Warnings section of the prescribing information and updated information in the Medication Guide for patients that further discuss the risk of mental health events when using these products.

Manufacturers also will be required to conduct a clinical trial to determine how often serious neuropsychiatric symptoms occur in patients using various smoking cessation therapies, including patients who currently have psychiatric disorders. The FDA’s review of adverse events for patients using nicotine patches did not identify a clear link between those medications and suicidal events.

Chantix is manufactured by New York-based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.

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Emerging Techniques Put a New Twist on Ankle Repair

/PRNewswire / -- People with ankle injuries who do not respond successfully to initial treatment may have a second chance at recovery, thanks to two new procedures developed to restore the injured area, according to a study published in the July 2009 issue of the Journal of the American Academy of Orthopaedic Surgeons (JAAOS).

The study reviews emerging techniques that have proven successful in treating injuries to the talus, the small bone, which is located between the heel bone and the lower bones of the leg. The talus helps form the ankle joint.

Although most injuries to the talus can be successfully treated using traditional "first-line" therapies involving removal of dead tissue (called "debridement") and drilling, about one-fifth to one-quarter of people with ankle injuries need additional "second-line" restorative treatment to heal successfully, said lead author Matthew Mitchell, M.D., an orthopaedic surgeon in private practice in Casper, Wyoming.

The two new techniques rely on cells grown in a lab, and eliminate the need for ostetomy (cutting the bone of the tibia) in some cases, he said.

-- Autologous chondorcyte implantation, or ACI, involves removing
cartilage cells from the knee or the ankle and growing them in a lab.
Once grown, the cartilage is transplanted to the talus. ACI usually
involves an ostetomy in order to implant the cells.

-- In matrix-induced autologous chondrocyte implantation, or MACI, cells
are grown on a special backing material, or "matrix," and then
transplanted to the talus. In the authors' experience, an osteotomy
is not necessary to implant the cells.


Of these two techniques, the newer MACI technique may offer the most benefits to the patient, according to Dr. Mitchell.

"Both ACI and MACI show a lot of promise, but I think the advantage of MACI is that an osteotomy is not necessary in order to successfully implant the matrix," he said. "You only need to make an incision to place the graft, which decreases the morbidity of the procedure quite a bit."

"In my experience so far with this emerging technique in Australia, the results have been as good as, or better than, other restorative techniques," he added. MACI is currently considered investigational by the FDA in the United States.

Traditional restorative techniques involve removing a cartilage donor plug from the knee and implanting it over the ankle injury, or "lesion." This requires an operation on the knee and cutting the bone (osteotomy) of the tibia to accommodate the graft. As a result, these traditional techniques involve potential problems, including:

-- pain in the donor knee
-- tissue damage in the donor knee
-- tissue damage in the ankle as a result of osteotomy

"In most individuals, results are favorable with reparative techniques, such as debridement and drilling," said Dr. Mitchell. "The lesions that are problematic and which don't respond well to reparative treatments are lesions that are larger, and those which are fairly deep, as well as lesions which have a cyst-like structure. Whether or not an ankle "lesion" requires additional treatment after an initial reparative procedure often depends upon several factors, including: size, depth and structure of the legion.

"Once you've performed a reparative technique and the patient still doesn't heal properly, then we would move on to a second-line restorative treatment," he said.

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