FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes

Arcalyst is first treatment for extremely rare condition called Cryopyrin-Associated Periodic Syndrome or CAPS

The U.S. Food and Drug Administration today approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Symptoms of both of these disorders include inflammation such as joint pain, rash or skin lesions, fever and chills, eye redness or pain, and fatigue in both children and adults; however MWS is associated with more severe inflammation and may include hearing loss or deafness. In addition, some MWS patients may also be affected by the buildup of a protein substance that damages organs and tissue (amyloidosis). The FCAS and MWS disorders affect about 300 people in the United States. CAPS disorders are inherited. Fifty percent of CAPS cases are associated with a gene mutation in the CIAS 1 gene.

"Arcalyst offers new promise for this small patient population suffering disorders associated with Cryopyrin-Associated Periodic Syndromes," said Curt Rosebraugh, M.D., M.P.H., acting director of the FDA's Office of Drug Evaluation II. "The Orphan Drug Act—now in its 25th year—has been tremendously successful in delivering effective treatments to patients with extremely rare, but serious, diseases."

Arcalyst blocks interleukin-1 which is a signaling protein secreted by certain immune-related cells in the body. Interleukin-1 acts as a messenger to regulate inflammatory responses, but in excess it can be harmful and has been shown to be key in the inflammation seen in CAPS sufferers with FCAS or MWS.

The FDA based its approval on a clinical study conducted by the manufacturer, which demonstrated the drug’s safety and effectiveness. Using a daily diary questionnaire, 47 patients rated the following five signs and symptoms of CAPS: joint pain, rash, feeling of fever/chills, eye redness/pain, and fatigue, each on a scale of zero (none/no severity) to 10 (very severe). Patients noted initial onset of relief of symptoms in their diaries within several days.

The most commonly reported side effects associated with use of Arcalyst were injection-site reactions and upper respiratory infections.

The FDA granted the drug a priority review, which speeds the review process for patients who have unmet medical needs.

Arcalyst is manufactured by Regeneron Pharmaceuticals Inc., Tarrytown, N.Y.

For more information on the Orphan Drug Act, visit: www.fda.gov/orphan/.
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FDA Approves Nexium for Use in Children Ages 1-11 Years

The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.

"This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions."

Nexium is part of a class of drugs known as proton pump inhibitors (PPIs). PPIs decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis.

FDA approved the use of Nexium in patients 1 to 11 years for short-term treatment of GERD based upon the extrapolation of data from previous study results in adults to the pediatric population, as well as safety and pharmacokinetic studies performed in pediatric patients. In one study, 109 patients 1-11 in age, diagnosed with GERD, were treated with Nexium once-a-day for up to eight weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their esophageal erosions after eight weeks of treatment.

The most common adverse reactions in children treated with Nexium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness. The safety and efficacy of Nexium has not been established in children less than one year of age.

Nexium is manufactured by AstraZeneca of Wilmington, DE.
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Mayo Researchers Look for Explanation Behind High Incidence of Diabetes Among Asian Indians

The incidence of type 2 diabetes is rising, especially in urbanized parts of the world where sedentary lifestyles and obesity abound. In addition to weight and inactivity, race puts some people at increased risk for developing type 2 diabetes. The incidence of diabetes is rapidly increasing globally, and Asian Indians have the highest prevalence. An estimated 32 million Asian Indians have been diagnosed with this condition, and some experts expect this number to double over the next 30 years. In a study published in the March issue of Diabetes, Mayo researchers examined whether Asian Indians have observable differences in the way their cells convert nutrient fuel to available energy and whether these differences may increase the risk for diabetes.

"We know that Asian Indians are highly susceptible to this condition, and they often acquire the disease at an earlier age and at lower body mass index than people of European origin," explains Mayo endocrinologist K. Sreekumaran Nair, M.D., Ph.D., the study's lead researcher. "The question we asked is whether any metabolic differences between Asian Indians and Americans of Northern European origin can explain the higher incidence of diabetes in Indians."

Once known as adult-onset or non-insulin-dependent diabetes, type 2 diabetes is a chronic condition that affects the way the body utilizes sugar (glucose). People with type 2 diabetes don't produce enough insulin — a hormone that regulates the absorption of sugar into cells — and their cells resist the effects of insulin (insulin-resistant). While death rates due to heart attack, stroke and even cancer are decreasing, deaths related to diabetes are increasing. Type 2 diabetes is the leading cause of cardiovascular deaths, kidney failure, blindness, sexual dysfunction and many other chronic complications.

Mayo researchers studied 13 diabetic Indians, 13 nondiabetic Indians, and 13 nondiabetic northeast Americans of European descent who were matched for gender, age and body mass to Indian study participants. Study participants were fed the same diet and underwent tests for insulin resistance and muscle biopsy to see whether differences occurred at the cellular level among the different study subject groups.

The study yielded a number of interesting findings. Researchers observed that the Indian subjects, irrespective of their diabetic status, had a greater degree of insulin resistance than the American subjects of Northern European origin, even though the study subjects were not obese, a condition commonly associated with insulin resistance. Earlier research has established that people with insulin resistance typically have poorly functioning muscle mitochondria. Mitochondria are the part of cells responsible for converting energy from nutrients to ATP (adenosine triphosphate), the chemical form of cellular energy that the body uses for almost all functions.

"Our study showed that the Indian diabetic and nondiabetic subjects with insulin resistance actually had mitochondrial function that was higher than those observed in the Northern European American subjects," says Dr. Nair.

Dr. Nair hypothesizes that key to understanding this difference may lie in an examination of how populations adapt as they become more urbanized. Urban societies typically move away from lifestyles that involve a higher level of physical activity and diets dominated by low-calorie foods.

"The higher capacity to produce ATP that the Indian subjects displayed may have been an adaptive advantage for the generations that preceded them, when energy content of their diet was lower. But today, this trait may be a disadvantage given the higher energy content of their current diets," explains Dr. Nair.

Dr. Nair and his team are hopeful that the information gained from this study will have a substantial impact on understanding the cause of the global epidemic in diabetes.

"Our findings have potential to help determine the energy requirements of different populations and what role this plays in the onset of diabetes" says Dr. Nair.

Other authors of this article are: Maureen Bigelow; Yan Asmann, Ph.D.; Lisa Chow; Jill Coenen-Schimke; Katherine Klaus; ZengKui Guo, Ph.D.; Raghavakaimal Sreekumar; and Brian Irving, Ph.D.

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Atlanta Hospitals and Heart Association Join Together to Communicate Dial 911 Heart Attack Message

While it is generally recognized that most hospitals and healthcare organizations naturally compete with one another for business and patients, a unique collaboration in the Atlanta area has actually teamed five hospitals together--all in the name of saving lives.

TIME works to decrease the time between the onset of cardiac symptoms and hospital treatment by transmitting full 12-lead EKG information from the transporting ambulance to one of the five hospitals, triggering activation of the hospital's emergency catheterization team and rapid intervention upon patient arrival. The primary focus of the project is closing the gap between onset of symptoms and interventional angioplasty versus the common focus of decreasing the amount of time from the door of the hospital to angioplasty.

Recently, the marketing and public relations departments with each hospital, as well as the American Heart Association, worked to develop an awareness communications campaign called "Dial Don't Drive," which is geared toward educating consumers to recognize the symptoms of a heart attack and to call for emergency help, rather than risk driving to an emergency room. The team tapped Atlanta-based Avid Design to develop a communication plan, including public service announcements, the development of a Web page (www.dial911atlanta.com) and the creation of educational DVDs.

"In partnership with the American Heart Association, these five hospitals that make up what we call the Metro Atlanta Cardiology Consortium, took it upon themselves to do more to save lives, and that mission was shared with the communication officers at each organization in an effort to highlight the importance of dialing 911 in the event of a heart attack, while also providing important information to help in recognizing when an individual may be suffering from a heart attack. We'll never be able to eliminate heart attacks completely, but the Atlanta metro area may be one of the best places in America to be in the event of a heart attack--in large part because of this level of medical collaboration," said Brooke Edmondson, Atlanta American Heart Association Communications Director.

As part of the TIME program, full 12-lead electrocardiographic (EKG) units have been placed in all of the ambulances that respond to 9-1-1 calls in Fulton County. All of these units have the capability to transmit the EKG immediately to one of the five hospitals that have been equipped with receiving units. The emergency physician at the hospital reads the EKG and activates the emergency catheterization team. Since the diagnosis can be made before the patient arrives, delays of registration and testing at the hospital can be avoided. Protocols have been established in each of the hospitals to streamline the movement.

"The Atlanta TIME Project is the first cooperative urban program in the United States developed to provide the most rapid response to a cardiac emergency by improving every step of care from the onset of symptoms to treatment at the hospital," says Bryan McNally, MD, emergency medicine physician at Emory University Hospital and co-director of the TIME program. "The time from the onset of the heart attack to the opening of the artery is critical in reducing heart damage and improving survival."

"Although all hospitals work on shortening the time of arrival to opening the artery, the TIME program concentrates on shortening the time from the onset of symptoms to stopping the attack with angioplasty," says Spencer King, MD, chair of interventional cardiology at the Fuqua Heart Center of Atlanta at Piedmont Hospital and co-director of the program.

For more information about the TIME program, please visit www.dial911atlanta.com.

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Oncology Patients Can Now Receive Treatment Close to Home Piedmont Fayette Adds New Technology to Cancer Services

Piedmont Fayette is expanding its cancer services, and soon cancer patients can receive treatment closer to home. Piedmont Fayette Hospital (PFH) has received approval to provide radiation therapy. The Certificate of Need (CON) application for a linear accelerator was recently approved by the Georgia Department of Community Health, Division of Health Planning.

"This community needs and deserves quality radiation oncology services close to home," said Darrell Cutts, president and CEO of Piedmont Fayette Hospital. "We are now looking forward to providing this much-needed service to our patients who won't have to travel great distances for a stressful, prolonged daily treatment regimen."

Nearly two years ago, Piedmont Fayette Hospital filed a CON application to add radiation therapy services to their portfolio of oncology services. While the CON meets Department of Community Health numerical need projections, as with all CON applications it is subject to appeal. In this case the approval process has been held up by an out-of-county competitor appealing the decision and delaying the Piedmont Fayette Hospital request. Patients undergoing this type of radiation treatment currently have limited options and must travel out of their community driving for 30 minutes to an hour each way and then spend at least 30 minutes of time within the actual treatment facility. This time commitment can be daily for several weeks and is not only inconvenient for patients and their families but can also impact the continuity of care.

A linear accelerator, the technology used in radiation therapy, kills or shrinks cancer cells. Radiation therapy is the primary form of treatment for some types of cancer. In other cases, it is used in conjunction with surgery and/or chemotherapy. This therapy is given on consecutive days over a four- to six-week period for patients suffering from breast cancer as well as other types of cancer.

"Rapid and recent advances in radiation technology make this an important investment, and it will help to provide a comprehensive continuum of oncology care for our patients," said Jonathan Bender, MD, of Peachtree Hematology Oncology Consultants and PFH Cancer Committee Chairman. "Fortunately now, our patients will have access to this important radiation therapy close to home."

Piedmont Fayette Hospital's range of oncology services from diagnosis, medical and surgical oncology, rehabilitative therapy services as well as nutritional, spiritual and support groups. For more information about Piedmont Fayette Hospital, visit www.fayettehospital.org.
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A must-see site for parents with teens or pre-teens...

In 1998, with bipartisan support, Congress created the National Youth Anti-Drug Media Campaign with the goal of preventing and reducing youth drug use. Unprecedented in size and scope, the Campaign is the most visible symbol of the Federal government's commitment to youth drug prevention. The Campaign is a strategically integrated communications effort that combines advertising with public communications outreach to deliver anti-drug messages and skills to America's youth, their parents and other influential adults.

http://theantidrug.com/

While illicit drug use by teens is declining, now there’s a threat from the family medicine cabinet: The abuse of prescription and over-the-counter drugs. But parents and caregivers can help to stop this dangerous trend.

Teens Turn Away From Street Drugs, Move To Prescription Drugs, New Report Reveals 2/14/2007Director of National Drug Control Policy John P. Walters today released a new White House analysis that shows alarming trends in teen abuse of prescription drugs and cough and cold medicines to get high.

New Campaign To Combat Teen Prescription Drug Abuse February 1, 2008The Office of National Drug Control policy launches a new effort to educate parents about teen prescription and over-the-counter drug abuse. Read More

Teens Are Abusing Benadryl to Get High KTRE-TV — 2/25/2008
Powerful and Dangerous Drugs Newsweek — 2/21/2008
Girls and Steroids: Anything to Be Thin ABC News — 2/20/2008
Trauma During Youth Linked to Increased Risk of Smoking USA Today — 2/20/2008
Pupils Popping Pills Portsmouth Herald News — 2/17/2008

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Governor Perdue Delivers Testimony to Congress Concerning State Children’s Health Insurance Program (SCHIP)

Governor Sonny Perdue today delivered testimony concerning the State Children’s Health Insurance Program (SCHIP) to the Subcommittee on Health of the U.S. House of Representatives Committee on Energy and Commerce.

“Georgia has done well in implementing SCHIP,” said Governor Sonny Perdue. “We’ve done too well – in fact, we’ve been penalized for it. We’ve enrolled so many kids in SCHIP that our percentage of uninsured children has dropped dramatically. And because of a flawed funding model that partially bases states’ allotments on the number of uninsured children, Georgia, along with our neighbors like Mississippi and North Carolina, are facing growing shortfalls.”

In his testimony, Governor Perdue again called on Congress to uphold its duty to appropriately fund the program and revise SCHIP’s funding formula to provide for a sustainable and stable future for this important program. As of January 2008, Georgia’s SCHIP program, PeachCare for Kids, provided health coverage to 234,720 children.

“If SCHIP were a snail darter or a purple bank climbing mussel, we would be suing the federal government under the Endangered Species Act,” added Governor Perdue.
Governor Perdue also asked Congress to keep the focus of the program on children. “The key principle of SCHIP is that children should always be top priority. Our resources must focus first on children,” said Governor Perdue. “This is not the case in every state right now. Some states have expanded their programs to include health insurance for other groups, even childless adults. But the goal of this program all along was to provide an answer to an insurance need for our most vulnerable population: low income children.”

Below is the text of Governor Perdue’s written testimony submitted for the Congressional Record:

Good morning, Mr. Chairman, and members of the Committee. Thank you for the opportunity to come before you today to discuss the progress we have made covering our nation’s uninsured children – more specifically, reauthorization of the State Children’s Health Insurance Program (SCHIP).

As most of you know, SCHIP is an issue about which I have been very vocal. I have been vocal because this is a program that works.

Ten years ago Congress made the health of our children a priority. A Republican Congress and a Democratic President worked together to create SCHIP, a federal-state partnership that would offer the children of low-income, hard-working parents the healthy start in life they deserve.

I have been vocal because SCHIP is a success. Georgia, the ninth largest state in the Union, has the fourth largest program in the country. We’ve significantly reduced the number of uninsured children in our state. The South has been especially successful, with more than 41% of the current SCHIP population enrolled in southern states.

We’ve seen this partnership get real results. It works. And it works because it promotes shared responsibility – shared between a family doing what it can and a compassionate public.

SCHIP is not a government handout. It is not for unemployed families on welfare. It helps the children of working parents who not only pay their taxes, but who also pay premiums for the insurance their children receive.

In Georgia we’ve maintained that shared responsibility and integrity in our program by verifying income and citizenship for each of our applicants. We require monthly premiums for coverage. And like anything else in life, there are consequences for failing to pay premiums.

I have been vocal because I know that families who buy coverage through SCHIP want for their children what we all want for our children. They simply want to have an annual check-up, to get basic immunizations, and to get regular screenings, just like my children received and your children received.

In Georgia, we’ve been extraordinarily successful in providing basic preventative treatment: roughly 90% of our young children enrolled in Georgia’s SCHIP Program (called PeachCare for Kids) for at least 10 months have received the immunizations they needed to prevent debilitating diseases, and over 80% had a primary care doctor.

I have been vocal because a program that works, a program that has a ten year record of proven success, is up for reauthorization and we can’t agree on how to continue.

In the last two years a growing number of states have faced shortfalls and have appealed to Congress to receive funding to continue their programs. Watching this, wondering how they will afford the rising costs of health care, are the working parents of millions of our nation’s children.

Georgia has done well in implementing SCHIP. We’ve done too well – in fact, we’ve been penalized for it. We’ve enrolled so many kids in SCHIP that our percentage of uninsured children has dropped dramatically. As a state we’ve grown by over 1.5 million citizens since the inception of the program, however we’ve cut the number of uninsured children by over 22%.

And because of a flawed funding model that partially bases states’ allotments on the number of uninsured children, Georgia, along with our neighbors like Mississippi and North Carolina, are facing growing shortfalls.

The better you are at implementing SCHIP, the less funding you receive. If a state was 100% successful and reached all eligible uninsured children, its funding the next year would be drastically cut – because no children would be uninsured.

Imagine if we used this same logic in our education system: a school that was tasked with reducing their drop-out rate and who achieved their goal of graduating 100% of their students would be rewarded with significantly less funding the following year. This just doesn’t make sense.

The current funding formula is also flawed because it hurts fast-growing states, like Georgia, by lagging behind by as much as four years in factoring in quickly-changing population numbers.

In our 2007 fiscal year, the federal government was using population numbers from 2004, 2003 and as far back as 2002. Georgia has grown by almost a million people since 2002. We need data that is reflective of the actual population and need.

I have been vocal about SCHIP because this formula flaw threatens the great progress we have made. I thank my good friend Congressman Nathan Deal for his efforts, along with Congress for addressing the funding shortfall while discussions continue on reauthorization of the program.

These debates give you the opportunity to revisit issues like this flawed formula, and I ask you now to address it in any bill signed into law.

I have been disappointed that the ongoing debate in Congress over the size of the program has completely overshadowed the great success the last ten years have seen.

Equally overshadowed is our opportunity to re-calibrate the program, to better target funding to states and programs that need it. There are several lessons and principles I would like to share with you as your discussions continue.

The key principle of SCHIP is that children should always be top priority. Our resources must focus first on children. This is not the case in every state right now.

Some states have expanded their programs to include health insurance for other groups, even childless adults. But the goal of this program all along was to provide an answer to an insurance need for our most vulnerable population: low income children.

It is a grave mistake to expand taxpayer funded insurance to a level that undermines personal responsibility for those who are able to purchase private insurance on their own. By focusing funding and enrollment efforts on low income children, we are reaching those most in need, those who have no other options.

It is not the role of government to provide health insurance for each and every citizen. Our role is to facilitate personal responsibility. We do this by giving people the information they need to make educated health care choices, and by creating tiers of options that help individuals graduate from public plans. Our goal is for everyone in Georgia to grow in their income such that they are ineligible for SCHIP or Medicaid, but to have affordable health insurance choices when they reach those income levels so that they can purchase a plan that meets their needs.

In Georgia, I have proposed a Health Insurance Partnership where small businesses, low income workers and the state and federal government can all share a portion of the cost of private insurance coverage. I have also proposed tax credits to incentivize businesses to offer affordable high deductible health plan coverage options, and we are working with doctors and hospitals throughout our state to make healthcare quality and cost information transparent and available to consumers, so they can be in the driver’s seat in choosing when and where they seek treatment.

As Governor of a state with a constitutional requirement for a balanced budget, I recognize that we simply do not have unlimited funds for SCHIP. There is a point of diminishing returns when you create a program that becomes so large that states can’t afford to participate.

Today we are in an uncertain economic environment where some states face daunting revenue shortfalls. Balancing state budgets means not everyone can continue to enroll uninsured children … and a program expansion will only cause less participation, enrollment caps or benefit reductions.

With a budget balanced on a yearly basis, a growing state match in a year of revenue shortfalls means cutting funding elsewhere.

Reauthorization of SCHIP allows us to revisit a program that is a nationwide success. It allows us to reevaluate what has worked well and what has not.

It gives us an opportunity to update the over a decade-old formula that we as a nation have outgrown, and to make sure we do not forget the mandate of the program – to ensure the health of our nation’s low-income children.

Is more funding needed? Yes. Both Congress and the administration recognize that. But I am very concerned that vast, unsustainable expansions will harm the long term viability of the good program we have now. By focusing funding on low income children and re-targeting a distribution formula that has not changed in a decade, states will continue to make progress in reaching and insuring our children.

As I have said many times, America is a compassionate nation. We must continue to take care of our most vulnerable citizens.

SCHIP is a success story. It’s a program that is proven to work. The proof is in the millions of American children who would have otherwise gone without vaccinations, without treatment for earaches and sore throats, without diagnosis of chronic diseases such as diabetes and asthma.

I have been vocal because there is no doubt in my mind that this program must be preserved with its original intent in mind. As you continue to debate its reauthorization and the long term goals, I ask that you look to Governors as a resource.

Thank you again for the opportunity to testify on this important issue.

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Health Care Spending Projected to Double by 2017

WASHINGTON — By 2017, total health care spending will double to more than $4 trillion a year, accounting for one of every $5 the nation spends, the federal government projects.
The 6.7 percent annual increase in spending — nearly three times the rate of inflation— will be largely driven by higher prices and an increased demand for care, the Centers for Medicare and Medicaid Services said Monday. Other factors in the mix include a growing and aging population. The first wave of baby boomers become eligible for Medicare beginning in 2011.
http://www.foxnews.com/story/0,2933,332592,00.html
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Study doubts effectiveness of antidepressant drugs

WASHINGTON (Reuters) - Antidepressant medications appear to help only very severely depressed people and work no better than placebos in many patients, British researchers said.
http://news.yahoo.com/s/nm/20080226/ts_nm/depression_drugs_dc

Study suggests antibiotics are overused

CHICAGO - A woman dying of Alzheimer's has a fever. Should she be given antibiotics? Many people would say yes. But a provocative new study suggests that antibiotics are overused in people dying of dementia diseases and should be considered more carefully because of the growing problem of drug-resistant superbugs.
http://news.yahoo.com/s/ap/20080226/ap_on_he_me/dementia_antibiotics
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Free Heart Screening and Educational Event Presented by Piedmont Hospital's Nicholas E. Davies Community Health Information Center

Piedmont Hospital’s Nicolas E. Davies Community Health Information Center invites the community to a free heart screening and educational event on Thursday, Feb. 28 at 12:30 p.m. Cardiologist Kenneth Taylor, M.D., medical co-director of the Fuqua Heart Failure Resource Center, will present “Heart Don’t Fail Me Now: Managing Heart Failure in the 21st Century” and answer questions. Following Dr. Taylor’s presentation, all attendees are welcome to participate in free, non-fasting screenings, which test for total cholesterol, HDL and glucose from 1:30-2:30 p.m. The Richard H. Rich Auditorium is in the 77 Building at Piedmont Hospital, 1968 Peachtree Road, N.W., Atlanta 30309. Refreshments will be provided.

Piedmont Hospital was recently recognized as Best in Atlanta for Overall Cardiac Care and Cardiac Surgery for 2008, according to The Tenth Annual HealthGrades Hospital Quality in America Study. Piedmont Hospital is the only metro Atlanta hospital to attain both the Cardiac Care and the Cardiac Surgery Excellence Awards and one of only 108 hospitals in the country to earn the distinction. Overall cardiac care includes performance in numerous cardiovascular services, including care for patients with heart attack and heart failure, which Taylor will discuss in his lecture.

Piedmont Hospital’s Nicolas E. Davies Community Health Information Center houses the latest resources to help healthcare consumers, patients, families, friends, and caregivers obtain current, reliable information. For more information, please call 404-605-2303 or visit www.piedmonthospital.org.
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CDC - Emergence of Fluoroquinolone-Resistant Neisseria meningitidis ― Minnesota and North Dakota, 2007-2008

Antimicrobial resistance is a growing problem and each new example stresses the importance of judicious use of antibiotics. The problem of ciprofloxacin-resistant N. meningitidis appears to be isolated to the North Dakota/Minnesota border region, and alternative medications are available. CDC is working to rapidly determine the extent of the problem. This report describes three cases of ciprofloxacin-resistant meningococcal disease that occurred among residents in selected counties of the border area of North Dakota and Minnesota during January 2007-January 2008. Until further notice, ciprofloxacin should not be used for prevention of disease in close contacts of those with meningococcal disease in those counties. Alternative medications are Ceftriaxone, rifampin, and azithromycin. Meningococcal disease causes substantial morbidity and mortality; approximately 10 percent of cases are fatal. Carrying N. meningitidis in the nose and throat is a precursor to developing the disease; however, most carriers do not develop the disease. Ciprofloxacin is one of several medications used to eliminate the carrying of N. meningitidis in close contacts. Although isolated cases of ciprofloxacin-resistant meningococcal disease have been described in other countries, until now, resistance to the medication had not been reported in North America.
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New and More Reliable Procedure for Common Shoulder Injury

Emory University doctors are using a new technique to repair a rotator cuff injury allowing it to heal more dependably and resulting in less likelihood that the patient will experience a re-injury.

The rotator cuff is composed of a group of four muscles that surround the ball of the shoulder joint. Tendons work with the associated muscles and provide mobility, stability and strength. Those tendons can weaken with age, overuse or injury and become vulnerable to a tear. Although a tear does not always require surgery, for those individuals who develop very significant pain, weakness or functional impairment surgery may be necessary.

Approximately half of rotator cuff repairs are done with a traditional "open" technique, using an incision that extends through the shoulder muscles. More recently, shoulder surgeons have employed a fiber optic camera, or arthroscope, to perform rotator cuff repair. Arthroscopic repairs require more surgical skill but use only small incisions, making the recovery less painful and potentially shorter than open repair.

Dr. Spero Karas, assistant professor in the Department of Orthopaedics, Emory University School of Medicine, is using a new technique for rotator cuff repair called the "double-row" arthroscopic repair. This procedure secures the tendon to the bone at two sites rather than one.

"It is much stronger than a typical 'single-row' arthroscopic repair and does a better job restoring normal rotator cuff anatomy," says Dr. Karas, who is part of the Emory Sports Medicine Center. "Recent studies also reveal that the 'double-row' repair heals in a more stable fashion, which results in better long-term outcomes.

"The operation itself takes a little longer to perform, about five minutes," says Dr. Karas. "However, the technique results in a much more substantial repair because there is actually more tendon attached to the bone."

There are thousands of shoulder injuries in the U.S. each year, some more serious than others. Persons likely to have a shoulder injury are athletes of any age, but the most affected are in their teens and 20s. Adults over the age of 45 are also at risk because their tendons become more vulnerable with age.

"Shoulder injuries are commonly caused by lifting heavy objects overhead or repetitive motions, especially above the shoulder," says Dr. Karas. "Taking 15 minute breaks while performing these activities can help one avoid shoulder injuries."

Dr. Karas also suggests that a rotator cuff strengthening program be employed by those persons who engage in activities stressful to the shoulder such as overhead work, tennis, baseball and swimming.
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New DASIS Report: Primary Methamphetamine/Amphetamine Admissions to Substance Abuse Treatment: 2005

Methamphetamine and amphetamines are highly addictive central nervous system stimulants. Methamphetamine and amphetamine abuse can lead to serious health consequences, such as rapid or irregular heartbeats, dental problems, mood disturbances, impaired memory, and chronic psychiatric problems. From 1995 to 2005, the percentage of substance abuse treatment admissions for primary abuse of methamphetamine/amphetamine more than doubled from 4 percent to 9 percent.

This report examines the characteristics of substance abuse treatment admissions in which methamphetamine/amphetamine was the primary substance of abuse and compares them with admissions in which other substances were primary.

The following are brief findings found in the report:
In 2005, 169,500 admissions were for primary methamphetamine/amphetamine abuse, representing 9 percent of all admissions
Primary methamphetamine/amphetamine admissions were more likely to be female than admissions for other primary substances (46 vs. 31 percent)
The criminal justice system was the principal source of referral for 49 percent of primary methamphetamine/amphetamine admissions compared with 34 percent of other admissions

Download DASIS Report:Primary Methamphetamine/Ampehtamine Admissions to Substance Abuse Treatment: 2005 (493 KB)

Order your free copy now! (DASISRPT08-0207)

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Novel Approach Strips Staph of Virulence

An international team of researchers supported by the National Institutes of Health (NIH) has blocked staph infections in mice using a drug previously tested in clinical trials as a cholesterol-lowering agent. The novel approach, described in the February 14 online edition of Science, could offer a new direction for therapies against a bacterium that's becoming increasingly resistant to antibiotics.

"By following their scientific instinct about a basic biological process, the researchers made a surprising discovery with important clinical implications," said NIH Director Elias A. Zerhouni, M.D. "Although the results are still very preliminary, they offer a promising new lead for developing drugs to treat a very timely and medically important health concern."

This work was supported by three NIH components: the National Institute of General Medical Sciences, the National Institute of Allergy and Infectious Diseases, and the National Institute of Child Health and Human Development.

A pigment similar to the one that gives carrots their color turns Staphylococcus aureus ("staph") golden. In the bacterium, this pigment acts as an antioxidant to block the reactive oxygen molecules the immune system uses to kill bacteria.

Researchers had speculated that blocking pigment formation in staph could restore the immune system's ability to thwart infection. While perusing a magazine on microbial research, Eric Oldfield, Ph.D., of the University of Illinois at Urbana-Champaign read how in 2005 University of California, San Diego researchers knocked out a gene in staph's pigment-making pathway to create colorless — and less pathogenic — bacteria.

"I looked at the metabolic pathway and noticed that it was similar to the one for the production of cholesterol in humans," said Oldfield, senior author of the Science paper, who had spent decades studying this pathway. With numerous cholesterol-lowering drugs already on the market and in development, he wondered if any could turn staph colorless and make them once again susceptible to the immune system.

Colleagues in Taiwan determined the structure of the enzyme that triggers the first critical step in staph's pigment formation and observed striking similarities to an enzyme involved in human cholesterol production. They also captured the structures of several cholesterol-lowering drugs bound to the bacterial enzyme.

Building on their 2005 research that sparked the current study, Victor Nizet, M.D., and George Liu, M.D., Ph.D., now at Cedars-Sinai Medical Center in Los Angeles, Calif., tested eight different drug compounds that act on the human cholesterol enzyme. Three blocked pigment production in laboratory tests. When the researchers treated mice infected with S. aureus with one of the compounds, the bacterial population was reduced by 98 percent.

Because the approach reduces the virulence of the bacteria by stopping pigment production, it may not cause selective pressures on the population, which can lead to antibiotic resistance. It also targets only S. aureus, possibly reducing side effects.

"This is an entirely new approach that seems to work in animals, and now we need to take the next step to explore if it will work in humans," said Oldfield.

Contributing authors also include Chia-I Liu, Ph.D., Wen-Yih Jeng, Ph.D., and Andrew H.-J. Wang, Ph.D., of the Academia Sinica in Taipei, Taiwan; Mary E. Hensler, Ph.D., of the University of California, San Diego; and Yongcheng Song, Ph.D., and Fenglin Yin, Ph.D., of the University of Illinois at Urbana-Champaign.
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Weight-Loss Surgery Can Cure Diabetes for the Obese

(BUSINESS WIRE)--An estimated three in every four obese people suffering from diabetes can be cured of the disease with bariatric surgery, according to a groundbreaking new study reported in the current edition of the Journal of the American Medical Association. Experts say this finding opens the door to changes in the treatment of diabetes that are as profound as the discovery of insulin.

“It’s truly exciting to see a medical study document what we have seen in our practice – patients with Type 2 diabetes can lose weight safely and reduce or eliminate their need for diabetic medications including insulin,” said Richard Collier MD, who along with Drs Matthew St. Laurent and Ata Ahmad, performs gastric band surgery at JourneyLite of Houston.

According to JAMA, researchers have found that 73 percent of patients, who underwent a stomach reducing surgical procedure, were cured of Type 2 diabetes when compared to only 13 percent of diabetics that followed other forms of conventional therapy - dieting, weight loss and medication - went into remission. Diabetes is the fifth-leading cause of death in the United States. The death toll from diabetes has grown by nearly 50 percent in the past 20 years.
Obesity is a growing national epidemic. From 1976 to 2004, the percent of adults (age 20 to 74 years in the United States who were obese) more than doubled from 15 to 32.9 percent. Nearly 20 million Americans have Type 2 diabetes.

How Gastric Bands Work

The band used in this bariatric study is surgically placed around the top of the stomach. Part of the stomach is stitched over it to hold the device in place, while the access port is secured closer to the skin. Once the band is in place, a saline solution can be injected into the access port. The fluid travels along the silicone tubing, and then fills the circular inflation membrane, making the band tighter. This constricts the stomach opening, and reduces the amount of space inside, giving the patient an earlier feeling of fullness, limiting food consumption. Adding or removing saline through the access port, according to the patient’s needs, can adjust the band’s tightness. This system allows for long-term, non-surgical adjustability.
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Avoid the Flu -- Stop the Spread of Germs that Make You and Others Sick

By Latrice Barlow, CMA, RHE, CCS-P, Clayton State University Nurse Managed Clinic

Influenza is a respiratory illness that is caused by flu viruses. Flu symptoms usually start to appear one to four days after the virus gets into your body. The flu is contagious and can be transferred to someone else one day before symptoms occur and up to five days after getting sick. The flu virus is spread mainly through respiratory droplets of coughs and sneezes. http://www.cdc.gov/flu/about/disease.htm.

Symptoms of the flu include sore throat, high fever, headaches, cough, muscle pains, and lethargy. http://www.cdc.gov/flu/about/disease.htm.

The flu can cause added medical complications for people in "high risk" groups, such as the elderly and children. http://www.cdc.gov/flu/about/disease.htm.

Different strains of the flu emerge each year, meaning that flu vaccines must be altered yearly. http://www.cdc.gov/flu/protect/keyfacts.htm.

Flu season can last anywhere from October to May. http://www.cdc.gov/flu/protect/keyfacts.htm.

The Centers for Disease Control recommends six good health habits for prevention…

1. Avoid close contact. Avoid close contact with people who are sick. When you are sick, keep your distance from others to protect them from getting sick, too.
2. Stay home when you are sick. If possible, stay home from work, school and errands when you are sick. You will help prevent others from catching your illness.
3. Cover your mouth and nose. Cover your mouth and nose with a tissue when coughing or sneezing. If no tissue is available cough or sneeze in your elbow. It may prevent those around you from getting sick.
4. Clean your hands. Washing your hands often will help protect you from germs.
5. Avoid touching your eyes, nose or mouth. Germs are often spread when a person touches something that is contaminated with germs and then touches his or her eyes, nose, or mouth.
6. Practice other good health habits. Get plenty of sleep, be physically active, manage your stress, drink plenty of fluids, and eat nutritious food.
If You Get Sick
Most healthy people recover from the flu without complications. If you get the flu, stay home, get lots of rest, drink plenty of liquids, and avoid using alcohol and tobacco.

There are over-the-counter (OTC) medications to relieve the symptoms of the flu (but never give aspirin to children or teenagers who have flu-like symptoms, particularly fever).

Remember that serious illness from the flu is more likely in certain groups of people including people 65 and older, pregnant women, people with certain chronic medical conditions and young children.

Consult your doctor early on for the best treatment.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.

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Novocell Reports Successful Use of Stem Cells to Generate Insulin in Mice

PRNewswire/ -- Novocell, Inc., a stem cell engineering company, today announced data demonstrating for the first time that human embryonic stem (hES) cells can be turned into pancreatic cells capable of producing insulin in mice. The findings are reported in an article appearing on-line today, in advance of print publication, in the journal Nature Biotechnology. This research provides evidence supporting the potential future use of hES cells to replace insulin-producing pancreatic cells that are destroyed in people with Type 1 diabetes, requiring them to receive regular insulin treatment.

The findings build on two previously reported studies by Novocell (Nature Biotechnology 2005 and 2006), whereby Novocell scientists demonstrated a process that successfully engineers hES cells into specific cells necessary for pancreas formation, and endocrine cells capable of producing insulin and other pancreatic hormones.

In this new work, Novocell has demonstrated that implantation of hES-derived pancreatic cells into mice results in the generation of glucose-responsive insulin producing cells. These cells exhibit properties characteristic of functional adult pancreatic insulin producing cells in the pancreas. Most importantly, these hES-derived cells provide protection in an animal model of diabetes characterized by loss of pancreatic insulin producing cells.

"Our data provide the first compelling evidence that hES cells can serve as a renewable source of functional insulin producing cells for diabetes cell replacement therapies," said Emmanuel Baetge, Ph.D., Chief Scientific Officer of Novocell and senior author of the publication. "It also provides strong evidence that hES cell-derived endoderm cells are able to generate glucose-responsive insulin secreting cells that are functionally similar to adult human beta cells."

Current cellular therapy for diabetes is performed by transplanting donor-derived human islets combined with chronic immunosuppression. While this has been demonstrated to be an effective therapy, the limited availability of donated pancreatic islets and the adverse side effects of long-term immunosuppression make this replacement therapy unsuitable for the general diabetes population.

Together with its stem cell engineering technology for insulin-producing cells, Novocell has also developed a delivery process by which such cells might be delivered to patients without the need for chronic immunosuppression. Novocell's encapsulation technology provides a protective, coating for cells, thus allowing them to be more readily accepted in the body without the chronic use of immunosuppressive drugs. This encapsulation technology has been successfully tested in human clinical trials using human islets isolated from donor organs.

"By developing proprietary processes to successfully generate insulin-producing cells from hES cells in vivo and protecting these cells from immune system rejection, we have created a potential treatment option that could lead to the first widespread application of cell replacement therapy for the treatment of diabetes," said Alan J. Lewis, Ph.D., President and Chief Executive Officer of Novocell. "We look forward to the continued advancement of these technologies that hold such promise for transforming the treatment of diabetes."
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March of Dimes Implores Legislators to Vote in Favor of Hearing Screen

PRNewswire-USNewswire/ -- The March of Dimes is making a House call -- House of Representatives that is. On February 21, 2008, the March of Dimes and volunteers from around the state will meet with legislators to discuss several issues, the most important of which is passage of House Bill 1177. This measure would require the state of Georgia to administer a hearing screen to all newborn infants.

Hearing is one of the 29 identifiable and treatable "core" disorders recommended for screening by the March of Dimes and the American College of Medical Geneticists (ACMG). Georgia currently requires screening for 28 and does not include hearing.

"Currently, 32 states and the District of Columbia require universal newborn hearing screening," says March of Dimes Georgia Chapter's State Director Mark Gibson. "It is critical that the state of Georgia step up and join the majority of the nation by providing the highest quality of care for all of our infants."

The Centers for Disease Control and Prevention (CDC) recommends that all babies be screened for hearing impairment before 1 month of age, preferably before they leave the hospital. Language and communication develop rapidly during the first two to three years of life, and undetected hearing impairment can lead to delays in developing these skills. Without newborn screening, children with hearing impairment usually are not diagnosed until 2 to 3 years of age.
House Bill 1177 is sponsored by Representative Judy Manning. In 2006, Representative Manning sponsored House Bill 1066, which expanded newborn screening to detect serious illnesses, severe disabilities, or potentially deadly genetic conditions that can be prevented if diagnosed and treated. House Bill 1066 was successfully passed in 2006.

In recent years, the March of Dimes has successfully lobbied for a reform to Georgia's health care system to require newborn screening. Screening is critical because it can identify disorders before symptoms arise and treatments can immediately begin. Lack of treatment can cause physical disabilities, mental retardation and even death. The goal of early hearing screening, diagnosis and treatment is to help children with hearing impairment develop language and academic skills equal to those of their peers. Most states have an Early Hearing Detection and Intervention Program to help ensure that all babies are screened, and that infants who do not pass the screening receive the follow-up care they need.

Visit www.marchofdimes.com/nbs or www.marchofdimes.com/georgia for more information on newborn screening, including a list of the recommended 29 disorders.

The March of Dimes is the leading nonprofit organization for pregnancy and baby health. With chapters nationwide and its premier event, March for Babies SM, the March of Dimes works to improve the health of babies. For the latest resources and information, visit marchofdimes.com or nacersano.org.
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Overweight and Obese Men Have Lower PSA Values, Even Before They Get Prostate Cancer

Men who are overweight or obese have lower concentrations of prostate-specific antigen (PSA) in their blood than their normal-weight counterparts, according to a new study led by Duke University Medical Center researchers.

The finding echoes earlier results on PSA concentrations found in obese and overweight men with prostate cancer and highlights the need to reconsider PSA threshold values for heavier patients, and to encourage those patients to get serious about losing weight.

"A study released last year from our group showed that obese and overweight men with prostate cancer had deceptively low PSA scores compared to normal-weight men with prostate cancer, but we now have extended our findings to show that this trend holds true in the general screening population," said Marva Price, R.N., a family nurse practitioner and researcher in Duke's School of Nursing, the Duke Comprehensive Cancer Center and the Duke Prostate Center.

"We found that mildly obese men's PSA scores were fourteen percent lower than normal-weight men, and moderately and severely obese men had 29 percent lower PSA values," Price said.
Doctors have proposed that overweight and obese men have lower PSA scores because their bodies have a greater volume of blood. Larger blood volumes dilute the amount of PSA in the bloodstream, making the concentration of PSA -- which is what is measured to screen for prostate cancer -- lower.

The latest results appear online in the Feb. 9, 2008 issue of the journal Urology. The study was funded by the United States Department of Defense.

PSA is considered the gold standard for detecting prostate cancer; it is a protein released into the blood by the prostate gland, and is elevated in the presence of cancer.

For this study, researchers looked at PSA scores among 535 men who took part in a free prostate cancer screening program. Seventy-three percent of the group was overweight or obese.

"The prevalence of obesity in the United States has doubled in the past 15 years," Price said. "Our study demonstrates yet another health danger that obesity poses. One in three Americans is obese, and a man who is 5'11" and weighs 215 pounds is considered obese."

The best advice clinicians can give their patients is to adopt healthier lifestyles, said Stephen Freedland, M.D., a urologist at Duke and the study's senior author. "We tell patients to exercise three or four times a week, eat a healthier diet, high in vegetables and fruits, and keep getting screened," he said. However, to compensate for the lower PSA values, Freedland also recommends lowering the PSA threshold that is considered abnormal for obese men. "If we don't do that, we may be missing cancers in obese men, which could lead to delayed diagnosis and poorer outcomes."

Other Duke contributors to this study include Robert Hamilton, Cary Robertson, and Maureen Butts.
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Disparities in Awareness of Heart Attack Warning Signs Among Adults in 14 States Revealed by CDC Study

An alarming number of adults fail to recognize heart attack warning signs and symptoms that could, if heeded, save their lives, according to a new Centers for Disease Control and Prevention (CDC) study conducted in 14 states.

The Morbidity and Mortality Weekly Report study, "Disparities in Awareness of Heart Attack Warning Signs and Actions among U.S. Adults in 14 States," found that men (22.5 percent), blacks (16.2 percent), Hispanics (14.3 percent), and those with less than a high school education (15.7 percent) are less likely to know the major signs of a heart attack. They were also least likely to call for emergency assistance; compared to women (30.8 percent), whites (30.2 percent) and those with higher educations (33.4 percent).

"The findings from the study may serve as an important indicator for other states and suggests that more public education and communication campaigns are needed to increase awareness, particularly among the high risk populations of men, blacks, Hispanics, and the under-educated and in those areas where awareness is low," said Dr. Jing Fang, the study's lead author and an epidemiologist in the CDC Division for Heart Disease and Stroke Prevention.

The warning signs of heart attack are pain or discomfort in the jaw, neck or back; feeling weak, lightheaded, or faint; chest pain or discomfort; pain or discomfort in the arms or shoulder; and shortness of breath.

Each year, about 920,000 Americans suffer a heart attack. Of those who die, about half of them die within an hour of the first symptoms and before they ever reach the hospital. The early recognition of heart attack warning signs by victims and bystanders and the immediate action of calling for emergency medical assistance are crucial for timely access to cardiac care, receipt of advanced treatment, and the increased potential for survival.

"In addition to the differences, it is clear the overall public awareness of heart attack signs and the importance of calling for emergency medical assistance quickly in the event someone is experiencing a heart attack or stroke was alarmingly low," said Dr.Fang. "Only about a quarter, or 27 percent, of those participating in the study who know all five major signs of a heart attack said they would also call 911 or otherwise seek emergency assistance if an individual appeared to be having a heart attack."

The study also found that the awareness of specific heart attack warning signs and the number of people who said they would call emergency medical personnel to report heart attack or strokes varied by states. The recognition of jaw, or back pain and discomfort as warning signs ranged from 34 percent in Washington, D.C. to 59 percent in West Virginia; feeling weak, lightheaded or faint ranged from 53 percent in Washington, D.C. to 70 percent in Iowa; chest pain and discomfort ranged from 86 percent in Tennessee to 96 percent in West Virginia; and pain or discomfort in the shoulder was from 77 percent in Washington D.C. to up 92 percent in West Virginia.

Study participants indicating that they would call for emergency assistance or call medical personnel to report a heart attack or stroke ranged from 78 percent in Mississippi to 89 percent in Minnesota.

For more information on the signs and actions of heart attack, visit the CDC Division for Heart Disease and Stroke Prevention Web site at www.cdc.gov/dhdsp. For more information on the risk of heart disease among various ethnic groups visit: http://www.cdc.gov/omhd/Populations/BAA/BAA.htm

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FDA Licenses New Hemophilia Treatment

The U.S. Food and Drug Administration today licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.

The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.Xyntha is licensed for the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in patients diagnosed with hemophilia A. Xyntha is also licensed to help prevent surgical bleeding in this patient population.

Xyntha is manufactured using recombinant DNA techniques that enable scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.

To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are modified to produce factor VIII. These CHO cells are free from known infectious agents, and Xyntha undergoes an additional process of viral inactivation. Also, the culture in which the cells are grown is free of any human or animal material.

"This product provides an additional treatment option for hemophilia A patients. This recombinant Factor VIII is produced without additives from human or animal material, which further minimizes any risk of infection from the product," said Jesse Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.

In clinical trials, Xyntha was shown to be effective at preventing or controlling bleeding, including preventing bleeding in surgery, for hemophilia A patients. Generally, the most frequently reported adverse reaction was headache. For those receiving Xyntha to prevent bleeding in surgery, the most frequently reported adverse reaction was fever. Most adverse reactions reported in either study were considered mild or moderate in severity.

In addition, two of 89 individuals who received 50 days of treatment with Xyntha, developed factor VIII inhibitors, which are antibodies that counteract treatment with factor VIII.

Xyntha is manufactured by Wyeth Pharmaceuticals Inc., located in Philadelphia.

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CDC State Preparedness Report Highlights Progress and Challenges

Improvements noted in disease detection, investigation, and laboratory response

An inaugural report on public health preparedness released today by the Centers for Disease Control and Prevention (CDC) indicates states have made significant progress with respect to emergency preparedness, but that significant challenges remain.

"This assessment of public health emergency preparedness is a major step forward," said Dr. Julie Gerberding, CDC director. "It illustrates the many specific ways that the investments we've been making since 2001 have increased states' capacity to quickly and effectively respond to a wide range of health hazards and emergencies. Today, for example, all states have emergency response plans, improved ability to identify and confirm public health threats, and more consistent and effective collaboration and communication between the many entities involved in responding to public health threats and emergencies."

More than $5 billion of federal funding has been distributed to the nation by CDC to improve public health preparedness and response since 2002.

"As a nation, we are better prepared today to respond to public health threats but the reality is that these efforts must be ongoing," said Richard Besser, M.D., director of CDC's Coordinating Office for Terrorism Preparedness and Emergency Response.

The CDC report, Public Health Preparedness: Mobilizing State by State, presents data that illustrate the progress state health departments have made in disease detection and investigation; laboratory testing capabilities; and planning, exercising and responding to public health emergencies. Key improvements from the report include:

* Disease detection and investigation. All state public health departments can now receive urgent reports about disease 24 hours a day, seven days a week. In 1999, only 12 states could do so. In addition, all states share information using the Epidemic Information Exchange (Epi-X), a secure, CDC-based communications system that helps track disease outbreaks. The number of users of this network nationwide has increased from 1,366 in 2001, to 4,646 in 2006.

* Public health laboratories. The number of laboratories that can test and analyze samples has nearly doubled since 2001.

* Response plans. All states have developed detailed emergency response plans to address all hazards, including an influenza pandemic. All states also now have plans to distribute the Strategic National Stockpile's federal caches of pharmaceuticals, antidotes, and medical supplies used for an emergency.

* Training. All public health departments now systematically and routinely train their workers in a wide range of crucial emergency response areas.

Work needs to continue

According to Besser, CDC's preparedness report is an important part of the agency's focus on measuring and documenting results, systematically using data to continuously improve programs and increasing accountability regarding the country's investment in preparedness activities.

"We recognize that CDC's report presents important data on some preparedness activities but does not provide information on all areas of preparedness," said Dr. Besser. "The nation's public health preparedness information and measures need to improve and CDC continues to engage with states and others to identify and incorporate effective public health emergency preparedness systems that enhance the nation's ability to respond."

CDC's approach has been to support public health preparedness for all hazards, including natural, biological, chemical, radiological, and nuclear events. This work falls under one of the agency's overarching health protection goals: "People prepared for emerging health threats - people in all communities will be protected from infectious, occupational, environmental, and terrorist threats."

CDC's report also provides a better understanding of where the major national and state challenges lie, and the areas where more progress needs to be made. Preparedness challenges include:

* Improving the ability to quickly dispense medicines and vaccines in an affected community
* Increasing the use of electronic health data for preparedness and response by networking surveillance systems
* Improving legal preparedness by helping states and other jurisdictions implement public health mutual aid agreements, which enable sharing of supplies, equipment, personnel, and information during emergencies
* Exercising public health systems to continuously improve capability and demonstrate readiness

CDC released the report during the annual Public Health Preparedness Summit in Atlanta today. The summit is coordinated by the National Association of City and County Health Officials. The report and state specific information is available on CDC's Web site at http://emergency.cdc.gov/publications/feb08phprep.

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AMA Foundation Honors Atlanta Physician for Increasing Access to Health Care in the U.S.

PRNewswire-USNewswire/ -- Joyce D. Kirkland Essien, M.D., M.B.A., of Atlanta, is a recipient of the 2008 Pride in the Profession Awards. Presented by the American Medical Association (AMA) Foundation, the award is given to domestic physicians who aid underserved populations in the U.S. The AMA Foundation presents the award in association with the Pfizer Medical Humanities Initiative.

The award will be presented on Monday, March 31st, at the 2008 Excellence in Medicine Awards Ceremony preceding the AMA National Advocacy Conference in Washington, D.C.
Dr. Essien serves as the Director of the Center for Public Health Practice at the Rollins School of Public Health, Emory University, and is a commissioned officer at the rank of Captain in the U.S. Public Health Service at the Centers for Disease Control and Prevention. Dr. Essien currently leads a team in collaboration with the Sustainability Institute that is building and applying simulation and syndemic modeling applications to diabetes to inform cross sectoral strategy, deliberation and decision support for policy formulation and strategic interventions at national, state and local levels to reduce the present and future burden of diabetes.

Dr. Essien is co-author of The Public Health Competency Handbook - Optimizing Individual and Organizational Performance for the Public's Health. The ZAP Asthma Consortium, Inc., co- founded by Dr. Essien, is a community health worker model for community-based asthma intervention, and this program is the recipient of the Rosalyn and Jimmy Carter Partnership Award. Among her many volunteer activities, she most recently established a not-for-profit foundation for the Carver Early College School, the first small school concept implemented within the Atlanta Public School System. Summing up Dr. Essien's work, one colleague stated that "the community is Dr. Essien's patient."

"Dr. Essien works tirelessly at the systems level to address issues such as diabetes and asthma, which are epidemics in this country," said AMA Foundation President Barbara Rockett, M.D. "She works to prevent illness, particularly in those populations who bear a disproportionate burden of disease."

The Pride in the Profession Awards were created by the AMA Foundation to honor physicians who, through their service, have brought a sense of pride to the medical profession and whose actions promote the art and science of medicine and the advancement of public health.
As the philanthropic arm of the American Medical Association, the AMA Foundation is committed to advancing healthcare in America through programs in medical education, research and public health. For more information, please visit http://www.amafoundation.org/ or call (312) 464-4200.

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Trauma in Childhood and Young Adulthood Can Lead To Smoking

Though cigarette use is declining among Americans in general, young adults exposed to traumatic events face a higher risk of developing a lifelong smoking habit, according to Duke University Medical Center researchers.

An emotional jolt or physical attack that occurs in early adulthood can double the odds that a person will start smoking regularly within a year of the incident, according to the study, which appears in the March edition of the Journal of Adolescent Health.

The research also finds a significant relationship between childhood physical or sexual abuse and regular, more frequent smoking that begins at an earlier age.

Earlier research on trauma and smoking focused mainly on patients, such as war veterans or rape survivors, and people in high-risk groups. The Duke study explores new ground by examining the relationship between trauma during childhood and young adulthood and subsequent smoking. The traumatic incidents include physical assault, interpersonal violence, unwanted sexual contact and childhood abuse that occurred before 6th grade.

"When people suffer a traumatic event, they can experience an emotional shock to the system," says Bernard Fuemmeler, Ph.D, one of the lead researchers of the study.

"Sometimes people turn toward substances like nicotine because they feel that it helps them cope," Fuemmeler said. "There is a great need to intervene early, especially among those who might be at high risk. If we know the warning signs of risky behaviors, like smoking, we may be able to prevent them."

Smoking remains the nation's leading preventable cause of death and disability, killing an estimated 440,000 people yearly. Every year, smoking costs the country $75 billion for medical treatment and $82 billion in lost productivity.

The most recent U.S. Surgeon General's report on smoking estimates that 4,000 young people smoke their first cigarette each day and that those who remain smokers die 13 to 14 years before nonsmokers.

The Duke researchers tracked a national sample of more than 15,000 adolescents between the ages of 16 and 22. Participants were divided into two groups: People who smoked regularly in the past year versus those who did not, and people who smoked regularly after the sixth grade versus those who did not.

Researchers adjusted the study to offset the effect of factors than can contribute to smoking, such as depression and parental educational level.

"Traumas any time in life may increase the risk of smoking," Fuemmeler says. "Although the mechanisms to explain these associations are not clear, it may be that helping individuals cope and adjust after being exposed to a trauma life event could reduce risky behaviors later in life, such as smoking."

The Duke research team included Miguel E. Roberts, Ph.D; Bernard F. Fuemmeler, Ph.D, M.P.H.; F. Joseph McClernon, Ph.D; and Jean C. Beckham, Ph.D.
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Limb Transplant Pioneer Establishing New Program at Emory

The only physician in the United States formally trained in hand surgery and transplant surgery is establishing a new program at Emory University School of Medicine to train other experts and to conduct research on what is still an extraordinary procedure.

Linda Cendales, MD, assistant professor of surgery at Emory University School of Medicine, helped organize the team that performed the first hand transplant in the United States in 1999 in Louisville, Kentucky.

At Emory, she wants to train the next experts in composite tissue allotransplantation (CTA)--the re-transplantation of limbs and other intact body parts.

That means having surgeons with the skills to repair bone, vessels, muscle, tendon, skin and nerves in marathon ten-hour operations as well as an understanding of the immune system after transplantation.

Dr. Cendales began work at Emory in November as director of the Laboratory of Microsurgery and Composite Tissue Transplantation. She is affiliated with the Emory Transplant Center and the Atlanta Veterans Affairs Medical Center.

"The future of this field relies on surgeons who understand the immune biology as well as the technical and rehabilitation aspects of CTA," says Dr. Cendales. "We need to start training surgeons in CTA."

The first hand transplant in the world was performed in 1964 in Ecuador, before the development of modern immunosuppressive medications. The recipient, a sailor, had to have the transplanted hand amputated two weeks after surgery because of tissue rejection.

The next hand transplant was performed in France in 1998 and endured more than two years before the recipient stopped taking immunosuppressive medication and asked to have the hand removed.

The Louisville team's hand transplant is currently the longest surviving hand transplant in the world. Dr. Cendales was also involved in the team's second hand transplant in 2001. A third patient had the same surgery in Louisville in 2006, and all three are still able to use their transplanted hands.

The primary cause of amputations in the United States is trauma. The first two U.S. hand transplant recipients lost their hands in a fireworks explosion and a work-related machine press accident.

Surgeons have already tackled many of hand transplantation's technical challenges, Dr. Cendales says. Issues involved in reattaching a severed limb, such as dealing with crushed bone or mangled connective tissue, can make "replantation" more technically demanding than an organ transplant, she says.

But the difficulty unique to transplantation comes from the regimen of drugs patients must take to prevent their immune systems from attacking their new tissues. Side effects from immunosuppressive medications can include diabetes, heart disease and an increased risk of cancer.

"We have an opportunity now to combine our continuing efforts to prevent graft rejection with Dr. Cendales' unique training and skills," says Christian Larsen, MD, DPhil, professor of surgery, director of the Emory Transplant Center and vice-chair of research at Emory. "Together we could really propel the field."

Composite tissue transplantation continues to advance by leaps and bounds, with recent reports from around the world of transplants involving donors' faces, knees, tracheae and even a uterus, performed in 2000 in Saudi Arabia.

Because of the risks and side effects and because these procedures can be seen as primarily "quality-of-life"-driven, some critics of these procedures say transplantation should be avoided if not life-saving.

"There is always a balance between the risks and the benefits of a quality-of-life procedure," says Dr. Cendales. "Recipients have to balance the benefits of having a transplanted hand against potential complications and side effects from the medications."

Limb transplantation also opens up considerations of body image, because the transplants are visible to the recipient and observers, she notes. Study of limb transplantation could provide insight into how the brain reorganizes after both injury and surgery and the phenomenon of "phantom limb pain."

Originally from Colombia, Dr. Cendales attended medical school in Mexico City. She credits her mentors, her colleagues and her collaborators for the advancements that her team has achieved in this new field. She joined the Christine M. Kleinert Institute for Hand and Microsurgery in Louisville, KY in 1997 and moved to the National Institutes of Health (NIH) in Bethesda, MD, in 2001, completing two fellowships.

While at Emory and the Atlanta VA Medical Center, Dr. Cendales plans to build the study of composite tissue allotransplantation systematically. She will continue the work she began at the NIH on forearm tissue transplantation in monkeys and a classification system for the severity of skin rejection after transplantation.

"We intend to establish a complete program leading from the laboratory bench to the bedside," she says.
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Mr. Diabetes(R) Hits 9,000 Mile Mark of 10,000+ Mile Walk to Raise Awareness About Diabetes

PRNewswire/ -- In rural Milledgeville, Georgia, 62 year old insulin-dependent Andy Mandell -- Mr. Diabetes(R), completed mile 9,000 of his 10,000+ mile perimeter walk of the United States raising awareness about the disease that nearly took his life.

"I've hit milestones in San Diego, Seattle, Chicago, Boston, and Washington DC, but small communities have the same rate of diabetes, only fewer resources to manage it. We can beat this disease locally, but it isn't going to happen on a national level. Unchecked, diabetes, which costs the U.S. $225 billion annually, will bankrupt our healthcare system," said Mandell.

Top diabetes researchers agree that a cure is at least 20 years away. The key to stopping diabetes is awareness and prevention through personal responsibility and lifestyle changes. Losing 10 - 15 pounds can make all the difference. Cut out fast food, snack foods and soda. Add 5-9 servings of fresh fruits, vegetables, legumes and whole grains to your daily diet.

"Pursue a more active lifestyle, like walking. Begin with ten minutes a day and increase the time gradually. It's a great way for families to catch up and get healthier at the same time," says Mandell. "These simple steps can delay the onset of diabetes and will help minimize complications," Mandell concluded.

Before THE WALK(TM) began there wasn't nearly the focus about diabetes that exists today. Mandell believes his efforts have impacted diabetes. THE WALK(TM) has captured the imagination of the public and Mr. Diabetes(R) is living proof that diabetics are neither helpless nor hopeless.

About the Wake Up and Walk(R) Tour

Now in its 7th and final year, Mr. Diabetes(R) is the sole walker. You may have seen him walking state highways in his brightly colored safety vest and walking pole. He's walked through 33 states, crossed 100 major rivers, 4 time zones (twice!), and gone through 22 pairs of walking shoes. He has met one-on-one with over 60,000 individuals and received over 100 Proclamations by Senators, Congressmen, Governors and Mayors. Through appearances and meetings at hospitals, such as Loma Linda, Johns Hopkins, Cleveland Clinic, schools, civic organizations, and the media he has reached over 65 million Americans. The Walk(R) continues through Florida before reaching the finish line in Madeira Beach, Florida in December of 2008.
For more information about diabetes, THE WALK(TM) and to make a tax-deductible donation: http://www.defeatdiabetes.org/
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Emory Begins Testing New Alzheimer's Disease Vaccine

Doctors at Emory University will begin testing a vaccine designed to slow the accumulation of amyloid plaques in the brains of patients with Alzheimer's disease.

Alzheimer's affects more than 4.5 million Americans and is marked by gradual nerve cell death and a progressive loss of memory and mental functioning. All of the medications now available aim to improve the functioning of the nerve cells that remain alive.

Several still-experimental vaccines or immunotherapies take a different approach. They target beta-amyloid, a naturally occurring protein that clumps together and forms plaques in the brains of Alzheimer's patients. The clumps appear to damage brain cells.

The study's main purpose is to evaluate the vaccine's safety, possible side effects and how well it stimulates the immune system.

"This is an exciting time for those who treat and care for people with Alzheimer's," says Allan Levey, MD, the principal investigator for the study and chairman of the Department of Neurology at Emory University School of Medicine. "By harnessing the patient's own immune system, it may be possible to change the course of the disease, rather than simply treat its symptoms."

Previous research on mice genetically engineered to develop an Alzheimer's-like condition has found that vaccination with beta-amyloid at birth protects them from plaque formation and mental decline. Older mice also showed some benefit from vaccination.

"Experiments in mice and still-limited evidence from human trials suggest that antibodies against the beta-amyloid protein can aid in clearing its buildup from the brain," Dr. Levey says.

An earlier clinical trial of a beta-amyloid vaccine in humans was halted in 2002 because a small fraction -- six percent -- of the participating patients developed meningoencephalitis, an inflammation of the brain and the tissue surrounding it.

The new vaccine, developed by the pharmaceutical firm Merck, uses a smaller piece of the beta-amyloid protein. The smaller piece is expected to stimulate antibody production but avoid activating T cells, which are the shock troops in an inflammatory response. This trial is the first time this vaccine will be used in people.

Despite the unacceptable safety profile of the previous vaccine, patients who developed antibodies against amyloid protein -- about 20 percent of those participating -- did appear to benefit.

As a group, "antibody responders" showed improvement on a set of tests designed to measure memory, decision-making and verbal ability, but not on other tests often used on patients with Alzheimer's, according to a 2005 study published in the journal Neurology.

Some antibody responders also showed reductions in the level of another protein called tau in their cerebrospinal fluid. Tau tends to build up inside neurons in Alzheimer's disease and scientists believe its presence in cerebrospinal fluid is related to cell death.

Other companies are testing related medications called passive immunotherapies, where a vaccine is replaced with pre-made antibodies either from human donors or engineered to resemble human antibodies. Emory researchers anticipate they will participate in these clinical trials later in 2008.

In the current study, sponsored by Merck, men and women ages 55 and older with mild to moderate Alzheimer's disease are eligible to participate. Several other medical centers across the United States and Sweden are also taking part.

The patient must have a reliable caregiver, who will attend all visits and answer questions about him or her. In addition, a patient must not live in a nursing home or facility, have another neurological disorder, have a history of stroke, drug or alcohol abuse, or have received blood donations or blood derived-products in the last six months.

"It is important for patients and caregivers to recognize that this is an experimental vaccine and some previous trials did fail," says Dr. Levey. "We can proceed only with a sense of balance and respect for patient safety."

Patients will receive three intramuscular injections of the vaccine or a placebo over the course of six months.

They will be monitored by magnetic resonance imaging (MRI) before each dose of vaccine to guard against indications of inflammation or other side effects. The study is expected to last for a total of four years.

For more information, call the Emory Alzheimer's Disease Research Center at 404-728-6950.
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CDC Warns of 'Choking Game' After 82 Youths Die

At least 82 youths have died from the so-called "choking game," according to the first government count of fatalities from the tragic fad.
In the game, children use dog leashes, bungee cords wrapped around their necks or other means to temporarily cut blood flow to their head. The goal is a dreamlike, floating-in-space feeling when blood rushes back into the brain.
As many as 20 percent of teens and preteens play the game, sometimes in groups, according to some estimates based on a few local studies.
http://www.foxnews.com/story/0,2933,330695,00.html
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Do You Make the Grade when It Comes to the ABCs of Multivitamins?

(ARA) – While the majority of Americans believe they are very or somewhat knowledgeable about multivitamins (67 percent), many do not know which vitamins and minerals are essential for the body or what vitamins and minerals are responsible for specific functions in the body, according to a survey released by the not-for-profit National Women’s Health Resource Center (NWHRC).

When asked which vitamin or mineral is essential for calcium absorption in the body (Vitamin D), more than a third of those surveyed said they were not sure. Surprisingly, when asked to identify vitamins and minerals that are not essential, only 44 percent correctly recognized that arsenic – a poison – is not an essential nutrient.

“When it comes to ensuring people get the vitamins and minerals they need in their daily diet, we were concerned by their lack of knowledge – especially among women, who are more likely to take an active role in promoting their family’s health,” says Elizabeth Battaglino Cahill, executive vice president of NWHRC. “We want people to have the knowledge and resources to understand what their bodies should have and to help them choose a multivitamin that fits their needs if they are not getting the right nutrients from their diet.”

In fact, about a quarter of Americans (24 percent) believe they get the vitamins and minerals they need by diet alone, but this is simply not the case – and although 51 percent of the individuals surveyed said they take a multivitamin, most of them do not know which vitamins and minerals are essential for their bodies.

Getting What the Body Needs

Taking a multivitamin is a simple step everyone can take to ensure they are getting the vitamins they need, if they are not getting the nutrients they need from their diet alone. And knowing those vitamins is half the challenge.

“People should know what vitamins and minerals their bodies need so they can make informed health decisions,” says Dr. Pamela Peeke, an internationally recognized physician, scientist and expert in the field of nutrition. “There are specially formulated multivitamins that have a balance of essential nutrients at recommended levels that work together to help people better customize their nutritional regimen.”

Many do not realize that multivitamin use can help promote and maintain good health, fill gaps in the diet and help bodies to function well.

The survey uncovered that 49 percent of Americans are very or somewhat concerned about LDL or bad cholesterol. “The good news is now there is a complete, daily multivitamin with phytosterols that is specifically designed to help lower LDL or bad cholesterol, which is a risk factor for heart disease – the number one killer of American women,” says Peeke.

To access more information about the survey and multivitamins, please visit www.healthywomen.org for simple nutrition tips, as well as important information about essential nutrients and multivitamins to help ensure that women and their families can make educated decisions about their nutrition needs.

Courtesy of ARAcontent
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Minimally Invasive Lung Cancer Surgery Can Improve Chemotherapy Outcomes

Patients who undergo a minimally invasive lung cancer surgery called thoracoscopic lobectomy may derive more benefit from the chemotherapy that follows, according to Duke University Medical Center researchers. These patients also have shorter hospital stays and accelerated recovery time compared with patients who have their tumors removed using the traditional surgical approach that involves opening the chest.

"This study showed that patients who had the minimally invasive operation were less likely to experience delays in receiving chemotherapy or a reduction in the amount of chemotherapy we were able to give," said Thomas D'Amico, M.D., a lung surgeon and senior investigator on the study. "Chemotherapy after surgery has been shown to improve survival in lung cancer patients, so the more effectively we deliver that chemotherapy, the better."

The researchers published the findings in the April 2007 issue of the Annals of Thoracic Surgery. The study was funded by Duke's Department of Surgery.

Thoracoscopic lobectomy is performed through two or three small incisions in the side of the chest. Surgeons insert a camera through one of the incisions and view the inside of the chest on a video screen, while manipulating instruments through the other incisions to remove the tumors. Open surgery to remove lung tumors -- called thoracotomy -- requires surgeons to make larger incisions and spread or cut the ribs in order to access the patient's lungs.

Doctors have been using thoracoscopic lobectomy as a surgical alternative for approximately 15 years; it can be an option for patients with non-small cell lung cancer, which is the most common type of lung cancer, making up 85 percent of all cases. The technique is most successful in patients whose tumors are less than six centimeters in size, D'Amico said.

Currently in the United States, only about 10 percent of lung cancer surgeries are performed thoracoscopically, but more than half of all patients requiring surgery to remove lung cancer might be candidates for the minimally invasive procedure, D'Amico said.

"The impetus for this study involved a speculation that if chemotherapy in addition to surgery improves outcomes, patients would benefit even more if chemotherapy were delivered in the most effective manner possible," said Rebecca Petersen, M.D., a general surgery resident at Duke and lead investigator on the study. "We found that thoracoscopy improves the ability to effectively deliver chemotherapy, which is yet another advantage of this minimally invasive technique."

Patients, especially those who have the traditional open surgery, often lose out on some of chemotherapy's benefits because their treatment is delayed or cut short due to surgery-related complications, such as bleeding or excessive inflammation, that could impair their immune systems, D'Amico said. The time it takes to recover from surgery could also reduce the efficacy of chemotherapy, and patients having a minimally invasive surgery recover faster, he said.

"This study showed that patients who had their tumors removed thoracoscopically were less likely to experience interruptions or delays in their chemotherapy delivery plan," he said.
Researchers looked at the outcomes, including delays or reductions in chemotherapy delivery, for 100 patients treated at Duke with either minimally invasive thoracoscopic surgery or traditional surgery. Eighteen percent of the patients who had the minimally invasive surgery experienced delayed chemotherapy, compared with 58 percent of the patients who had the traditional surgery, D'Amico said.

Only 26 percent of the thoracoscopic group experienced a reduction in the dosage of their planned chemotherapy regimen, compared to 49 percent of patients who underwent the open-chest surgery, he said.

Other researchers in the study were DuyKhanh Pham, William Burfeind, Steven Hanish, Eric Toloza and David Harpole.
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