FDA Approves New Use of Xifaxan for Patients with Liver Disease

The U.S. Food and Drug Administration today approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease. This is a new use for Xifaxan (rifaximin), a drug that has been approved for the treatment of traveler’s diarrhea.

Hepatic encephalopathy is a worsening of brain function that can occur in patients whose liver can no longer remove toxins from the blood. Increased levels of ammonia in the blood are thought to play a role in the development of HE, and Xifaxan works by reducing these levels.

“The approval of Xifaxan for this new indication provides an additional treatment option for patients with liver disease,” said Joyce Korvick, M.D., deputy director for safety of FDA’s Division of Gastroenterology Products. “Hepatic encephalopathy occurs commonly in patients with liver disease, and there are few effective treatments for this serious condition.”

The efficacy of Xifaxan was established in a randomized placebo-controlled clinical trial of adult patients from the United States, Canada, and Russia. Patients with liver disease who entered the trial had no or mild symptoms of HE. Patients treated with Xifaxan were less likely to develop HE during the trial, compared to placebo-treated patients.

Xifaxan was not studied in patients with the most severe forms of liver disease. Since most patients were also taking lactulose (a synthetic sugar which helps prevent absorption of ammonia from the intestine) during the trial, the efficacy of Xifaxan as a stand-alone treatment for HE could not be assessed.

The most common adverse reactions reported with the use of Xifaxan in patients with liver disease include swelling of the arms and legs (peripheral edema), nausea, gas, and headache.

Xifaxan received a priority review under FDA’s new drug application process and was granted orphan designation status. Xifaxan is manufactured by Salix Pharmaceuticals Inc. of Morrisville, N.C.

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Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk

FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.

The agency recently became aware that an independent U.S. academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in Rotarix, which is manufactured by GlaxoSmithKline. PCV1 is not known to cause illness in humans or other animals. In addition, Rotarix has been studied extensively, before and after approval, and found to have an excellent safety record.

Follow-up tests by GlaxoSmithKline and FDA scientists confirmed the academic team’s findings and confirmed that viral components have been present since the early stages of the vaccine’s development, including during clinical studies. Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq, has not detected components of PCV1.

"We are making clinicians aware of information recently received by FDA about the Rotarix vaccine,” said Dr. Margaret A. Hamburg, Commissioner for Food and Drugs. “There is no evidence at this time that there is a safety concern. FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation. We will keep the public and the clinical community updated on our findings.”

Rotarix and RotaTeq are given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration and is estimated to be responsible for the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries. Before the introduction of a rotavirus vaccine, rotavirus resulted in more than 50,000 hospitalizations and several dozen deaths in the United States each year. FDA licensed RotaTeq in 2006 and Rotarix in 2008. Most children vaccinated in the United States received RotaTeq.

“In many countries, rotavirus causes so much severe illness and death that the known benefits of continued use of Rotarix far outweigh any theoretical risk of harm from the vaccine,” said Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention. “We anticipate that many countries will decide to continue vaccinating with Rotarix while more information becomes known.”

FDA will continue to gather more information about the PCV1 components in Rotarix, including whether intact virus, as opposed to DNA fragments, is present. The agency is assessing current vaccine testing methods. In four to six weeks, FDA will convene an expert advisory committee and make additional recommendations on the use of rotavirus vaccines.

FDA will provide updates to patients, providers, and the general public as more information becomes available. The agency will also continue to communicate with the World Health Organization and counterpart regulatory agencies in other countries.

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FDA Approves Drug to Treat Condition That Causes Elevated Ammonia Levels

The U.S. Food and Drug Administration today approved Carbaglu (carglumic acid) Tablets to treat a condition that results in too much ammonia in the blood.

The condition, N-acetylglutamate synthase or NAGS deficiency, is an extremely rare, genetic disorder that can be present in babies soon after birth. NAGS deficiency and the resulting elevated levels of ammonia (hyperammonemia) can be fatal if it is not detected and treated rapidly. DNA testing can confirm the diagnosis of NAGS.

“We are very excited that more drugs are being developed to treat very rare but often devastating genetic disorders" said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “We hope to see continuing progress in this area.”

The safety and efficacy of Carbaglu was studied in 23 patients with NAGS who received the treatment for times ranging from six months to 21 years. In these patients, Carbaglu reduced blood ammonia levels within 24 hours and normalized ammonia levels within three days. The majority of those in the study appeared to maintain normal plasma ammonia levels with long-term Carbaglu treatment.

Side effects experienced by those using Carbaglu included vomiting, abdominal pain, fever, tonsillitis, anemia, ear infection, diarrhea, inflammation of the nose and throat, and headache. As with all FDA-approved products, the agency will continue to monitor Carbaglu as it is used to treat hyperammonemia.

Carbaglu should only be administered by a physician experienced in treating metabolic disorders. The recommended initial dose of Carbaglu is 100 to 250 mg/kg/day for treatment of acute hyperammonemia. Use of other ammonia-lowering therapies with Carbaglu during episodes of acute hyperammonemia is recommended. Dosing should be adjusted based on a patient’s ammonia levels and symptoms.

Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/MedWatch/HowToReport/default.htm1.

Carbaglu is manufactured by Orphan Europe.

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Piedmont Heart Institute Physicians Partner with US AGAINST ATHERO to Educate on Heart Disease

Piedmont Heart Institute Physicians have teamed up with US AGAINST ATHERO, to bring the Artery Explorer experience to its office at 20 Francis Way, Suite 101 in Sharpsburg. In addition to this unique educational experience, visitors will have a chance to tour the facility, meet the cardiologists, have their blood pressure checked and learn their body mass index (BMI) for free on site. The event is Saturday, March 20 from 10 a.m. to 4 p.m.

As part of US AGAINST ATHERO, the Artery Explorer is touring the country to increase awareness of atherosclerosis—the dangerous buildup of plaque in the arteries. This incredible virtual experience allows viewers to surf through arteries on a journey deep inside the body. The movie demonstrates how risk factors like high levels of bad cholesterol, smoking and high blood pressure can contribute to the buildup of plaque in arteries.

Coronary heart disease and stroke kill more Americans every year than all cancers combined. Atherosclerosis, or athero for short, is often the leading cause. It is the progressive buildup of plaque in the arteries linked to about one in four deaths in the United States each year.

All are encouraged to stop by for their free blood pressure check and body mass index (BMI) analysis. Artery Explorer will be available for viewing throughout the day in addition to face painting for children. Refreshments will be served.

For more information call 770-716-2008 ext. 1606 or visit athero.com.
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FDA Approves First Totally Implanted Hearing System

The U.S. Food and Drug Administration today announced the approval of the Esteem – an implanted hearing system used to treat moderate to severe sensorineural hearing loss, a type of permanent hearing loss.

Sensorineural hearing loss is usually caused by genetic factors or damage to the inner ear resulting from noise, viral infections, or aging. The results are reductions in perception of sounds and in the ability to understand speech.

This differs from conductive hearing loss, which occurs when sound waves cannot transmit well through the outer or middle ear or both. Medical or surgical treatment can often restore hearing in people with a conductive hearing loss, which can be caused by earwax, fluid in the middle ear space, or a punctured eardrum.

The Esteem system consists of external testing and programming instruments and three implantable components: a sound processor, sensor, and driver. The sensor senses vibrations from the eardrum and middle ear bones and converts these mechanical vibrations into electrical signals, which are then sent to the sound processor, which amplifies and filters the signal to compensate for the individual patient’s hearing loss. The driver converts the enhanced electrical signal back to vibrations, which are then transmitted into the inner ear where they are perceived as sound.

“The approval of Esteem provides patients with an option to alleviate their hearing loss by using a device with no readily visible external components,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The system is designed to alleviate the effects of hearing loss in patients ages 18 years and older. Other criteria for the device include: stable bilateral sensorineural hearing loss, a normally functioning Eustachian tube, and normal middle ear anatomy. A patient’s ability to understand speech using Esteem should be similar to that of conventional hearing aids.

In a multicenter clinical study of Esteem versus pre-implant hearing aids, 93 percent of Esteem recipients scored equal to or better than their pre-implant hearing aids on a speech intelligibility test. Seven percent scored less than with their pre-implant hearing aids, and 56 percent scored better than with their pre-implant hearing aids.

Seven percent of participants experienced facial paralysis, and 42 percent experienced taste disturbance, both of which are results of the surgical procedure necessary to implant the device. The majority of these adverse events resolved during the one-year study period.

As a condition of FDA approval, Esteem manufacturer, Envoy Medical Corporation of St. Paul, Minn., must conduct two post-approval studies. In one study, Envoy must continue to follow-up on 61 subjects from the original study for five years to study safety and effectiveness. Another study of 120 newly enrolled subjects will include an evaluation of the incidence of facial paralysis at one month after implantation, and evaluate the effectiveness of Esteem five years after implantation.

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Vertebroplasty for Patients With Osteoporosis Provides Effective Pain Relief

/PRNewswire/ -- Patient selection is key for vertebroplasty--a minimally invasive treatment performed by interventional radiologists in individuals with painful osteoporotic vertebral compression fractures that fail to respond to conventional medical therapy--to be effective and successful, according to a study of more than 1,500 persons who were followed over seven years. Additionally, collaboration between an interventional radiologist and other medical experts in treating a patient is imperative, say researchers at the Society of Interventional Radiology's 35th Annual Scientific Meeting in Tampa, Fla.

"Vertebroplasty puts lives and vertebrae back together," said Giovanni C. Anselmetti, M.D., interventional radiologist at the Institute for Cancer Research and Treatment in Turin, Italy. Before treatment, many osteoporotic patients are in constant pain and cannot manage everyday activities. Vertebroplasty, a minimally invasive treatment performed by interventional radiologists under imaging guidance, stabilizes collapsed vertebrae with the injection of medical-grade bone cement into the spine. The treatment provides pain relief and improves one's quality of life--if given to appropriately selected candidates in whom conventional medical treatment has failed (such as analgesics or narcotic drugs that provide minimal or no pain release or doses that are intolerable), he further explained. "Our long-term follow-up confirmed this: pain relief and quality of life significantly improved with vertebroplasty," said Anselmetti.

Osteoporosis, the most common type of bone disease, is characterized by low bone mass and structural deterioration of the bone, resulting in an increased susceptibility to fractures. Osteoporosis affects 10 million Americans and is responsible for 700,000 vertebral fractures each year. Multiple vertebral fractures can result in chronic pain and disability, loss of independence, stooped posture and compression of the lungs and stomach.

"Vertebroplasty dramatically improves back pain within hours of the procedure, provides long-term pain relief and has a low complication rate, as demonstrated in multiple studies," said Anselmetti. Vertebroplasty provides pain relief from the complications of osteoporosis (vertebral fractures) but not the disease that caused it (osteoporosis), said Anselmetti. "For the best results, collaboration between physicians is mandatory. All osteoporotic patients need to be followed by an interventional radiologist, who determines which patients are appropriate candidates to receive vertebroplasty treatment, and an experienced medical expert (in this study, a rheumatologist) to ensure continued treatment for osteoporosis," he said.

Anselmetti illustrated a typical case: an 80-year-old Italian woman, who was diagnosed last year with two painful osteoporotic vertebral collapses, underwent medical treatment for osteoporosis (with the drug teriparatide) and was still in pain when she was prescribed an external brace. After there was evidence of two new fractures (verified by MR imaging), she received vertebroplasty, experiencing "complete pain regression, no need for the brace and a dramatic Lazarus-like ability to perform daily activities," he noted.

Researchers studied 2,251 osteoporotic patients (1,811 women; average age, 65) suffering from back-pain for vertebral collapses (MRI confirmed) who underwent a clinical interview; their medical treatment, pain grade, quality of life and extent of vertebral fracture were reviewed. Vertebroplasty was performed in 1,542 patients (1,302 women; average age, 73) when optimal medical treatment (such as biphosphonates, teriparatide, analgesics and back brace) did not help relieve pain or improve quality of life for patients over a three-month period. After vertebroplasty, patients continued to receive medical treatment with a rheumatologist. Because interventional radiologists use high-quality, image-guiding systems (such as digital flat-panel fluoroscopy with built-in rotational image acquisition), treatment time is decreased, making for a safer procedure, added Anselmetti.

In 1,494 patients (96.9 percent), the average pretreatment pain score on the 11-point visual analog scale was 8.2+/-1.8, and it dropped "significantly" to an average of 1.1+/-1.6 after vertebroplasty treatment, said Anselmetti. A patient's ability to manage everyday life--such as washing, dressing or standing--was measured by the commonly used Oswestry Disability Questionnaire, which was completed by patients before and after vertebroplasty. The ODQ scores changed from an average of 68.7+/-7.6 percent to 18.5+/-8.2 percent. Long-term follow-up (average, 31.2 months) in 1,017 patients (857 women; average age, 72) showed the VAS significantly dropping from 7.9+/-1.5 to 1.3+/-1.7. Of the 757 patients wearing a back brace before vertebroplasty, 683 could stop wearing one after treatment.

Anselmetti said that additional studies need to be performed, such as a large randomized trial comparing conventional medical treatment to medical treatment plus vertebroplasty. In Europe, this is difficult, as patients with chronic back pain for vertebral osteoporotic fractures prefer to be treated by vertebroplasty--and not randomized into a medical treatment-only group. "Patients who are in so much pain ask if they can be considered for vertebroplasty treatment," said the co-author of "Percutaneous Vertebroplasty (PV) in the Osteoporotic Patients: Optimal Indications and Patient Selection to Improve Clinical Outcome: Personal Experience in 1,542 Patients Over Seven Years' Experience."

More information about the Society of Interventional Radiology, interventional radiologists and vertebroplasty can be found online at www.SIRweb.org.

Abstract 16: "Percutaneous Vertebroplasty (PV) in the Osteoporotic Patients: Optimal Indications and Patient Selection to Improve Clinical Outcome: Personal Experience in 1,542 Patients Over Seven Years' Experience," G.C. Anselmetti, A. Manca, G. Chiara, G. Iussich and D. Regge, all at the Institute for Cancer Research and Treatment, Candiolo, Italy; and G. Isaia, University of Turin, Turin, Italy, SIR 35th Annual Scientific Meeting March 13-18, 2010, Tampa, Fla. This abstract can be found at www.SIRmeeting.org.

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A Better Genetic Test for Autism

/PRNewswire/ -- A large study from Children's Hospital Boston and the Boston-based Autism Consortium finds that a genetic test that samples the entire genome, known as chromosomal microarray analysis, has about three times the detection rate for genetic changes related to autism spectrum disorders (ASDs) than standard tests. Publishing in the April issue of Pediatrics (and online March 15), the authors urge that CMA become part of the first-line genetic work-up for ASDs.

Expectant parents who have family members with ASDs, as well as families who already have an affected child, often request genetic testing. However, there is still only limited knowledge about actual causative genes. The currently recommended tests (karyotyping to look for chromosomal abnormalities and testing for Fragile X, the single largest known genetic cause of ASDs) often come up negative. Chromosomal microarray analysis (CMA) is a genome-wide assay that examines the chromosomes for tiny, sub-microscopic deletions or duplications of DNA sequences, known as copy-number variants.

CMA offers about 100-fold greater resolution than standard karyotyping. However, since it is new, it is often considered a second-tier test. Depending on where a person lives, or what insurance they have, CMA may not be covered by health insurance. "Based on our findings, CMA should be considered as part of the initial clinical diagnostic evaluation of patients with ASDs," says Bai-Lin Wu, PhD, Director of Children's DNA Diagnostic Lab in the Department of Laboratory Medicine, which has offered CMA to families since 2006.

The research team, led by co-senior authors Wu (heading the Children's team), and David Miller, MD, PhD, of Children's Division of Genetics and Department of Laboratory Medicine (heading the Autism Consortium team), assessed the diagnostic value of CMA in the largest cohort to date - 933 patients with a clinical diagnosis of ASD (by DSM-IV-TR criteria) who received clinical genetic testing in 2006, 2007 and 2008.

Half were Children's patients who had their samples submitted to the hospital's DNA Diagnostic Laboratory, and the others were recruited through the Autism Consortium, a research and clinical collaboration of five Boston-area medical centers. Nearly half of the patients were diagnosed with autistic disorder, nearly half with PDD-NOS (pervasive developmental disorder - not otherwise specified) and about 3 percent with Asperger disorder. Ages ranged from 13 months to 22 years.

Testing included the two currently used tests (G-banded karyotype and fragile X), as well as CMA. When the researchers compared the tests' diagnostic yield, they found:

-- Karyotyping yielded abnormal results in 2.23 percent of patients
-- Fragile X testing was abnormal in 0.46 percent
-- CMA results were judged to be abnormal in 7.3 percent of patients when
the entire length of the chromosomes (the whole genome) was sampled.


Extrapolating from these results, the researchers estimate that without CMA, genetic diagnosis will be missed in at least 5 percent of ASD cases. CMA performed best in certain subgroups, such as girls with autistic disorder, and past studies indicate that it also has a higher yield in patients with intellectual disability (who constituted only 12 percent of this sample).

"CMA clearly detects more abnormalities than other genetic tests that have been the standard of care for many years," says Miller. "We're hoping this evidence will convince insurance companies to cover this testing universally."

In all, roughly 15 percent of people with autism have a known genetic cause. Establishing a clear genetic diagnosis helps families obtain early intervention and services for autism, and helps parents predict the possibility of having another child with autism.

In addition, by pinpointing bits of chromosomes that are deleted or duplicated, CMA can help researchers zero in on specific causative genes within that stretch of DNA. They can also begin to classify patients according to the type of deletion or duplication they have, and try to find specific treatment approaches for each sub-type of autism.

"Just in the last two years, a number of studies have revealed the clinical importance of ever smaller chromosome deletions and duplications found with advanced microarray technology," says Wu. "These new, highly-efficient tests can help in the evaluation or confirmation of autism spectrum disorders and other developmental disorders, leading to early diagnosis and intervention and a significantly improved developmental outcome."

Two known chromosome locations - on chromosome 16 (16p11.2) and chromosome 15 (15q13.2q13.3) accounted for 17 percent of abnormal CMA findings. Both chromosome abnormalities were initially linked with ASDs by Children's Hospital Boston and collaborators in The New England Journal of Medicine and the Journal of Medical Genetics, respectively, in 2008. Children's now offers specific tests targeting both of these "hot spots."

However, the researchers note that most copy-number changes were unique or identified in only a small number of patients, so their implications need further study. Many of them are presumed to be related to ASDs because they involve important genes, cover a large region of the chromosome, or because the child is the first person in that family to have the change.

"Some deletions and duplications are rare and specific to one individual or one family," says Miller. "Learning about them is going to be an evolving process. There won't be one single test that finds all genetic changes related to autism, until we completely understand the entire genome."

The paper's co-first authors were Autism Consortium members Yiping Shen, PhD, of Children's Department of Laboratory Medicine and the Center for Human Genetic Research at Massachusetts General Hospital, and Kira Dies, ScM, LGC, of the Family Research Network of the Autism Consortium and Children's Multi-Disciplinary Tuberous Sclerosis Program. A number of specialists from Children's Departments of Neurology, Developmental Medicine and Clinical Genetics and physicians from other medical centers in greater Boston were also authors on the study. The research was supported by the Nancy Lurie Marks Family Foundation, the Simons Foundation, Autism Speaks and the National Institutes of Health.

Families interested in scheduling an appointment at Children's may call the Developmental Medicine Center (617-355-7025) or the Department of Neurology (617-355-2711).

Citation: Shen Y; et al. Clinical genetic testing for patients with autism spectrum disorders. Pediatrics 2010 Apr; 125(4):e1-e17. (Published online March 15)

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FDA Announces New Boxed Warning on Plavix

/PRNewswire/ -- The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form.

Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.

People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These "poor metabolizers" may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.

"We want to highlight this warning to make sure health care professionals use the best information possible to treat their patients," said Mary Ross Southworth, Pharm.D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.

In May 2009, the FDA added this warning to the drug's label. After reviewing more data, the agency felt it was important to highlight this risk in a boxed warning.

It is estimated that 2 percent to 14 percent of the U.S. population are poor metabolizers. The FDA recommends that health care professionals consider alternative dosing of Plavix for these patients, or consider using other anti-platelet medications. Tests are available to assess CYP2C19 genotype to determine if a patient is a poor metabolizer.

Patients should not stop taking Plavix unless told to do so by their health care professional. They should talk with their health care professional if they have any concerns about Plavix.

Plavix is made under a Bristol-Myers Squibb - Sanofi Pharmaceuticals partnership.

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New, National Amnesty International Report Finds Appalling U.S. Death Rate for Women Having Babies, Systemic Failures and Shocking Disparities in Maternal Health Care System; Georgia is 50th Among All States in Maternal Mortality

/PRNewswire/ -- In releasing a new report on maternal health nationwide, Amnesty International today revealed that flaws and shocking disparities in maternal health care that the government is ignoring lead to two to three women dying daily in the United States from pregnancy-related complications, with half of these deaths believed preventable, according to the Centers for Disease Control. A state-by-state examination shows that Georgia is 50th on a maternal mortality ranking, with 20.5 deaths per 100,000 live births.*

The new Amnesty International report, Deadly Delivery: The Maternal Health Care Crisis in the USA, also reveals that severe pregnancy-related complications that nearly cause death -- known as "near misses" -- are rising at an alarming rate, increasing by 25 percent since 1998; currently nearly 34,000 women annually experience a "near miss" during delivery. With a lifetime risk of maternal deaths that is greater than in 40 other countries, including virtually all of the industrialized countries, the United States has failed to reverse the two-decade upward trend in preventable maternal deaths, despite pledges to do so.

The report cited numerous causes for the crisis and offers lengthy recommendations on improving maternal health care.

Inadequate prenatal care is cited as a contributing factor in the crisis; women who do not get prenatal care are three to four times more likely to die than women who do. In Georgia, almost one in six women (15.8 percent) receive delayed or no prenatal care. The number rises to one in five women (21.9 percent) among women of color.

Obstacles to care are widespread: the most obvious being that across the United States nearly 13 million women of reproductive age (15 to 44), or one in five, have no health insurance. In Georgia nearly one in five women (19.7 percent) are uninsured; among women of color the number of uninsured climbs to 27.6 percent. The state's Medicaid eligibility level for working parents is also very low, $9,072. Lack of access to health care centers and providers is a problem nationwide, the report found; in Georgia 41 percent of women live in medically underserved areas.

"No issue can be more central to the health and well-being of our nation than maternal health care," said Jared Feuer, Southern Regional Director for Amnesty International USA. "The government should accept its duty and its moral obligation to address this inexcusable crisis by developing a comprehensive plan to ensure quality health care for all pregnant women. If the federal government can address steroid use in baseball, certainly lawmakers can address maternal health, which affects every family in the United States."

Maternal health is a human right for every woman in the United States, regardless of race or income. Yet, the United States lacks a systematic, robust government response to this critical problem. Amnesty International is urging President Obama to work with Health and Human Services Secretary Kathleen Sebelius to establish, and seek Congressional funding, for a single office responsible for ensuring that all women receive quality maternal health care. An Office of Maternal Health would lead government action to reduce the soaring pregnancy-related complications and maternal deaths nationwide.

Additionally, Amnesty International calls for vigorous enforcement of federal non-discrimination laws and an increase in support for Federally Qualified Health Centers by 2011 to expand the number of women who can access affordable maternal health care.

"This country's extraordinary record of medical advancement makes its haphazard approach to maternal care all the more scandalous and disgraceful," said Larry Cox, executive director of Amnesty International USA. "Mothers die not because the United States can't provide good care, but because it lacks the political will to make sure good care is available to all women."

Amnesty International's analysis shows that health care reform before Congress does not address the crisis of maternal health care.

"Reform is primarily focused on health care coverage and reducing health care costs, and even optimistic estimates predict that any proposal on the table will still leave millions without access to affordable care," said Rachel Ward, one of the authors of the Deadly Delivery report. "Furthermore, it does not address discrimination, systemic failures and government accountability documented in Amnesty International's report."

Rapid and comprehensive federal leadership is required, as the report found numerous systemic failures, including the following:

-- Burdensome bureaucratic procedures in Medicaid enrollment
substantially delay access to vital prenatal care for pregnant women
seeking government-funded care. Twenty-one states do not offer
"presumptive eligibility" which allows pregnant women to temporarily
access medical care while their permanent application for Medicaid is
pending. Women who do not receive any prenatal care are three to four
times more likely to die than women who do.
-- The number of deaths is significantly understated because there are no
federal requirements to report maternal deaths or complications and
data collection at the state level is insufficient.
-- Oversight and accountability is lacking. 29 states and the District of
Columbia have no maternal death review process at all.


Amnesty International is a Nobel Peace Prize-winning grassroots activist organization with more than 2.2 million supporters, activists and volunteers in more than 150 countries campaigning for human rights worldwide. The organization investigates and exposes abuses, educates and mobilizes the public, and works to protect people wherever justice, freedom, truth and dignity are denied.

For more information or to take action, please visit: www.amnestyusa.org/deadlydelivery

*National Women's Law Center, National Report Card on Women's Health, Maternal Mortality Rate Table; available at

http://hrc.nwlc.org/Status-Indicators/Key-Conditions/Maternal-Mortality-Ra te.aspx.

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MAG's "Doctor of the Day" Featured in Telemedicine Demo

Gary C. Richter, M.D., the president of the Medical Association of Georgia (MAG), is applauding Georgia Lt. Gov. Casey Cagle and the state’s Speaker of the House of Representatives, Rep. David Ralston, for their leadership in promoting telemedicine as an innovative way of enhancing the patient-physician relationship during a demonstration that took place in concert with MAG’s “Doctor of the Day” program at the Medical Aid Station at the Capitol this afternoon.

MAG member Debra B. Lister, M.D., performed exams on Lt. Gov. Cagle and Speaker Ralston using a live video feed from more than 200 miles away in her office at the Coffee Regional Medical Center in Douglas.

The Georgia Partnership for TeleHealth, Inc. (GPT) provided the equipment and the network that was used to conduct the demonstration. GPT says telemedicine can deliver some immediate health care and costs savings benefits in a number of sectors, including trauma care, corrections, schools, mental health and nursing homes. It adds that Georgia’s telemedicine network now extends to more than 100 rural areas and includes more than 110 specialists representing more than 40 specialties, including dermatology, psychiatry, neurology, endocrinology and pediatrics. GPT says the state’s telemedicine network was used more than 18,000 times in 2009.

Dr. Richter says MAG is an advocate for evaluating telemedicine and other electronic health care initiatives, noting the organization formed an electronic health care committee in 2008 that is chaired by Jack M. Chapman Jr., M.D., that is charged with, “…developing a base of knowledge and expertise within the Medical Association of Georgia to identify, track and positively impact the rapidly changing field in which technology intersects with the delivery of health care.”

Of the demonstration, he said, “We believe telemedicine has the potential to enhance patient care, reduce costs, and build on existing patient-physician relationships by leveraging some incredible technology. This could be especially true for rural and underserved areas.”

The “Doctor of the Day” program began in 1968. Working out of the MAG-sponsored Medical Aid Station at the Capitol, physician volunteers provide free, minor medical care to legislators and their staff for one or more days during the legislative session.

With more than 6,000 members, MAG is the leading voice for physicians in Georgia. Go to www.mag.org/electronichealthcare for additional information. Also follow MAG on Twitter at www.twitter.com/MAG1849.
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Volunteers Are Urgently Needed for Free Health Clinic for Uninsured

Volunteers are urgently needed for a one-day, free health clinic in the Atlanta area this month that is expected to serve more than 1,000 uninsured Georgia residents.

“More than 18 percent of Georgia’s non-elderly population is uninsured, demonstrating a great need for access to free medical services,” National Association of Free Clinics (NAFC) Executive Director Nicole Lamoureux said. “In addition to providing needed medical services on the day of the event, this clinic is designed to connect the uninsured to ongoing medical resources.”

The C.A.R.E. (Communities Are Responding Everyday) Clinic is scheduled for March 27 at the Georgia International Convention Center near Atlanta from 9:00 a.m. until 5:00 p.m. It is sponsored by the NAFC and the Georgia Free Clinic Network (GFCN), which includes 18 free clinics around the state.

“Medical volunteers are urgently needed including doctors of medicine, doctors of osteopathy, nurse practitioners, physician’s assistants, registered nurses, licensed vocational nurses, emergency medical technicians, medical administrators, licensed clinical social workers and more,” GFCN Executive Director Donna Looper said. “We also need non-medical volunteers to help with documentation, logistical support, patient intake and translation, as well as to be patient greeters and escorts.”

Volunteers can find out more information and register online at http://www.regonline.com/Atlanta_CARE_Clinic. Those interested in attending the clinic as a patient may call 1-877-233-5159 to make an appointment now.

“It is important to note that being uninsured is not the same as being unemployed,” Lamoureux said. “About 83 percent of uninsured people have jobs. At past C.A.R.E. Clinics, we found that many of the patients worked at two or more jobs but did not receive health insurance benefits. Some even worked as nurses or for insurance companies but still did not have insurance themselves.”

Dr. Craig Dietz, the Clinical Director of the Kansas City Free Clinic, has been a volunteer at all of the previous C.A.R.E. clinics that were held in Houston, New Orleans, Little Rock, Kansas City and Hartford. At these clinics over 7,000 uninsured people received free medical care. “Being involved in these clinics has been a rewarding experience,” says Dr. Dietz. “We look forward to working with the Georgia community and adding to the approximately 7,000 previous C.A.R.E. clinic volunteers to help put on this important event.”

About the National Association of Free Clinics:

The National Association of Free Clinics is the only nonprofit 501(c) (3) organization whose mission is solely focused on the issues and needs of more than 1,200 free clinics and the people they serve in the United States.

Founded in 2001 and headquartered near Washington, D.C., the NAFC is an effective advocate for the issues and concerns of free clinics, their volunteer workforce of doctors, dentists, nurses, therapists, pharmacists, nurse practitioners, technicians and other health care professionals, as well as the patients served by free clinics in communities throughout the nation.

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CDC Study Finds U.S. Herpes Rates Remain High

/PRNewswire/ -- About 1 in 6 Americans (16.2 percent) between the ages of 14 and 49 is infected with herpes simplex virus type 2 (HSV-2), according to a national health survey released today by the Centers for Disease Control and Prevention. HSV-2 is a lifelong and incurable infection that can cause recurrent and painful genital sores.

The findings, presented at the 2010 National STD Prevention Conference, indicate that herpes remains one of the most common sexually transmitted diseases (STDs) in the United States.

The new estimate, for 2005-2008, comes from CDC's National Health and Nutrition Examination Survey (NHANES), a nationally representative survey of the U.S. household population that assesses a broad range of health issues.

The findings suggest relatively stable HSV-2 prevalence since CDC's last national estimate (17 percent for 1999-2004), because the slight decline in prevalence between the two time periods is not statistically significant.

The study finds that women and blacks were most likely to be infected. HSV-2 prevalence was nearly twice as high among women (20.9 percent) than men (11.5 percent), and was more than three times higher among blacks (39.2 percent) than whites (12.3 percent). The most affected group was black women, with a prevalence rate of 48 percent.

As with other STDs, biological factors may make women more susceptible to HSV-2 infection. Additionally, racial disparities in HSV-2 infection are likely perpetuated because of the higher prevalence of infection within African-American communities, placing African-Americans at greater risk of being exposed to herpes with any given sexual encounter.

"This study serves as a stark reminder that herpes remains a common and serious health threat in the United States. Everyone should be aware of the symptoms, risk factors, and steps that can be taken to prevent the spread of this lifelong and incurable infection," said Kevin Fenton, M.D., director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. "We are particularly concerned about persistent high rates of herpes among African-Americans, which is likely contributing to disproportionate rates of HIV in the black community."

Research shows that people with herpes are two to three times more likely to acquire HIV, and that herpes can also make HIV-infected individuals more likely to transmit HIV to others. CDC estimates that over 80 percent of those with HSV-2 are unaware of their infection. Symptoms may be absent, mild, or mistaken for another condition. And people with HSV-2 can transmit the virus even when they have no visible sores or other symptoms.

"Many individuals are transmitting herpes to others without even knowing it," said John M. Douglas, Jr., M.D., director of CDC's Division of STD Prevention. "We can't afford to be complacent about this disease. It is important that persons with symptoms suggestive of herpes -- especially recurrent sores in the genital area -- seek clinical care to determine if these symptoms may be due to herpes and might benefit from treatment."

Combination of Prevention Approaches Needed to Reduce National Herpes Rates

Although HSV-2 infection is not curable, there are effective medications available to treat symptoms and prevent outbreaks. Those with known herpes infection should avoid sex when herpes symptoms or sores are present and understand that HSV-2 can still be transmitted when sores are not present. Effective strategies to reduce the risk of HSV-2 infection include abstaining from sexual contact, using condoms consistently and correctly, and limiting the number of sex partners.

CDC does not recommend HSV-2 screening for the general population. However, such testing may be useful for individuals who are unsure of their status and at high risk for the disease, including those with multiple sex partners, those who are HIV-positive, and gay and bisexual men.

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FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers

The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis.

“Muscles affected by spasticity have increased stiffness and tightness, which may lead to pain, difficulties with hygiene and other activities of daily living, and may affect how a patient looks,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In clinical trials, treatment with Botox was found to be beneficial to patients with upper limb spasticity.”

Botox works by temporarily blocking the connections between nerves and muscles, resulting in a temporary paralysis of the spastic muscle.

Botox has a Boxed Warning that says the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening.

The most common adverse reactions reported by patients with upper limb spasticity were nausea, fatigue, bronchitis, muscle weakness, and pain in the arms.

Botox has not been shown to be safe and effective treatment for other upper limb muscles, spasticity in the legs, or for treatment of fixed contracture – a condition that affects range of motion. Treatment with Botox is not intended to substitute for physical therapy or other rehabilitative care.

Botox is manufactured by Allergan Inc. of Irvine, Calif.

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Mayo Clinic Reports its First Lung Transplantation by Donation After Cardiac Death

Lung transplantation is a well-known therapy for patients with end-stage lung disease, but, as with other patients waiting for organs for transplantation, there are more recipients waiting than donors available. A potential solution for patients with end-stage lung disease is donation after cardiac death (DCD). Mayo Clinic reports its - and Minnesota's - first lung transplantation from DCD in the February issue of Mayo Clinic Proceedings.

While brain death has become the most widely used criteria for organ donation over the past few decades, the earliest organ donations were from deceased donors following cardiac death, says Stephen Cassivi, M.D., Mayo Clinic thoracic surgeon and lead study author. "Today, our critical shortage of organs has brought about renewed interest in DCD organ procurement," he says. Few centers across the country perform DCD organ procurement for lung transplantation, and until recently only about 60 procedures have been done in the United States.

Mayo's first DCD lung transplantation was performed a year ago in a 59-year-old Illinois man who had alpha-1antitrypsin deficiency - an inherited condition associated with emphysema. Emphysema is a type of chronic obstructive pulmonary disease, which includes a group of conditions that block airflow and make breathing difficult. He also was a former tobacco user.
Almost one year after his transplant, the recipient says he is doing well, walking about three or four miles a day. "I would not have made it through 2009 without the transplant, and today I am feeling better than I have in years and am able to be with my family," he says. "I feel very lucky and am grateful to my donor and his family."

Before his transplant, the patient's forced expiratory volume in the first second (FEV1) - a measure of lung function and the ability to breathe - was at 20 percent of normal, but at his appointment in January 2010, his FEV1 was at 103 percent, beyond normal, according to Dr. Cassivi. "He has made the absolute most of this gift," Dr. Cassivi says. "He's no longer confined to just sitting around. He is working his lungs and getting back to enjoying his life and the ability to breathe normally."

Transplantation made possible by DCD donors - individuals who are declared dead according to criteria recommended in the Uniform Declaration of Death Act in the early 1980s - expands the number of potential organs available to patients who desperately need organ transplants to live, Dr. Cassivi says. "As with our first patient in this report, we see this form of transplantation as a further needed opportunity to turn the inevitable tragedy for the donor and his or her loved ones into hope and life for transplant recipients," he says.

A peer-reviewed journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. Articles are available online at www.mayoclinicproceedings.com.
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FDA Approves Name Change for Heartburn Drug Kapidex

The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant.

Since Kapidex was approved in January 2009, there have been reports of dispensing errors because of confusion with the drugs Casodex (bicalutamide) and Kadian (morphine sulfate), which have very different uses from Kapidex and from each other.

Kapidex is a proton pump inhibitor used to treat heartburn and other conditions by reducing the amount of acid produced in the stomach. Casodex, marketed by AstraZeneca, is used to treat men with advanced prostate cancer. Kadian, distributed by Actavis Kadian LLC, is an opioid analgesic used to treat pain.

“The FDA is pleased to have worked with Takeda to take swift and responsible steps to change the name of this product in the interest of patient safety,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The FDA evaluates new drug names before a product is approved to minimize confusion with existing drugs. Sometimes unexpected name confusions can occur once the product goes to market.

To improve this safety process, the FDA has issued a new guidance for industry titled Contents of a Complete Submission for the Evaluation of Proprietary Names. The guidance explains what information should be submitted to help in the evaluation of a proposed proprietary drug or biologic name, and to ensure compliance with other requirements for labeling and promotion.

These efforts are part of the agency’s Safe Use Initiative which was launched in November 2009. The goal of this initiative is to reduce preventable medical errors through collaboration with public and private institutions.

There will be no changes made to Kapidex other than its name. Health care professionals and other individuals responsible for ordering, stocking, and billing for the product should be aware that Dexilant will have a new National Drug Code (NDC) number associated with the product.

Individuals and health care professionals who have questions about the name change should contact Takeda at 877-TAKEDA-7.

Medication errors involving Dexilant or any other medications should be reported to the FDA’s MedWatch program online at http://www.fda.gov/medwatch1.

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84% of Physicians Polled will have to Stop Seeing Medicare Patients if Reimbursement Cuts Pass

/PRNewswire/ -- Sermo (http://www.sermo.com/), the world's largest online community for physicians, today announced physician reaction to the Medicare cuts effective March 1st, 2010. Nearly 1,500 physicians participated in an online poll and discussion measuring how they will respond to the reimbursements cuts. Of the respondents, 84% said they will have to stop seeing new Medicare patients, stop seeing all Medicare patients or consider closing their practices altogether.

This cut in reimbursements will dramatically impact both the physicians providing care and the patients. As one Oncologist noted, "Ultimately, it's the patients who will suffer."

Many practices, private and group, will be opting out of Medicare as of March 1st. One Family Practice Physician said, "My primary care group (the largest in our county) will stop accepting new Medicare patients Monday, and if the cuts stick, terminate care for 25-50% of the existing patients and require all new patients with commercial plans to sign up for our retainer offering. We have a leaflet ready explaining the reasons why and how to contact our Congressman and Senators."

Many physicians explained they simply cannot make up for the declining payments by increasing volume of patients seen. For some practices, the bulk of the physician's patients are on Medicare/Medicaid. One Doctor of Osteopathy shares, "Medicare makes up about 50% of my practice. I cannot afford to stop seeing them all together right now. Either way I will have to significantly change my practice to reduce overhead to survive the cut."

Physicians are particularly disillusioned by what they believe is Congress' attempt to control the practice of medicine. One surgeon writes, "The government cannot be allowed to legislate that we take on unprofitable endeavors. It is time for all physicians to take a stand for a fare wage." A Dermatologist added, "Medicare needs to get out of the price-fixing business."

To view the full discussion and polling results, visit the Sermo Blog at http://sermo.com/blog. The Sermo Blog (www.sermo.com/blog) highlights the most vibrant discussions happening. Discussions on Sermo are physician-initiated and cover topics ranging from medical ethics & practice management to challenging clinical cases. All physicians on Sermo are verified as licensed in the US.

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FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland

The U.S. Food and Drug Administration today approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination.

The most common symptoms of BPH include a weak stream during urination, urgency, leaking or dribbling, as well as more frequent urination, especially at night.

BPH is common among older men. According to the National Institutes of Health, it rarely causes symptoms before age 40, but more than half of men in their 60s and as many as 90 percent of men older than 70 have BPH symptoms.

"The approval of generic tamsulosin offers greater access to a widely used treatment for BPH," said Gary Buehler, director of the FDA’s Office of Generic Drugs. "FDA is committed to making generic drugs available to patients and these drugs meet the same rigid standards as the brand name drugs."

The prescribing information and safety warnings for the generic version of tamsulosin are the same as those for Flomax Capsules. Generic tamsulosin capsules are manufactured by IMPAX Laboratories Inc. of Haywood, Calif. Information about the marketing and availability of this generic drug can be obtained from the manufacturer.

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New Bethel AME Church, Lithonia, Offering Free Health Screenings

The Health Ministry of New Bethel AME Church is offering free health screenings and assessments at a Health Fair on Saturday, March 13, 2010 from 11:00 am to 3:00 pm. In addition, on Friday, March 12, the Dekalb Medical Center Care-a-Van will be at the church to provide mammograms.

The Saturday program will include rapid HIV testing, dental screenings, prostate screenings, blood pressure screenings, diabetes screenings, mental health information, and more. Throughout the day there will be a presentation on mental health information for adolescents.

New Bethel AME Church is committed to serving the community through their outreach ministry. They are located at 8350 Rockbridge Road, Lithonia, GA 30058. For information about the Health Fair or directions, please call 770-484-3350.
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Free Health Care for the Uninsured Is Coming to Atlanta This Month

Volunteers Can Register Now

Georgians struggling with the lack of health insurance will soon get much-needed help when the National Association of Free Clinics (NAFC) in conjunction with the Georgia Free Clinic Network (GFCN) holds its next C.A.R.E. Clinic at the Georgia International Convention Center in Atlanta on March 27 from 9:00 a.m. until 5:00 p.m.

This will be the sixth in a series of large, mostly one-day C.A.R.E. (Communities Are Responding Everyday) Clinics held around the country to bring together physicians and other health care professionals, as well as non-medical volunteers, to serve the needs of thousands of people who might otherwise go without medical care. Since last September, more than 7,000 uninsured patients received treatment at C.A.R.E. Clinics in Houston, New Orleans, Little Rock, Kansas City and Hartford.

“As long as affordable health insurance is not available for everyone, there will be a great need for the work that more than 1,200 free clinics across the country do every day,” NAFC Executive Director Nicole Lamoureux said.

In Georgia, almost 18 percent of the non-elderly residents do not have health insurance.

“We are excited to be able to hold a C.A.R.E. Clinic in Georgia, where the work of free clinics is very much needed,” Donna Looper, executive director of the Georgia Free Clinic Network, said. “A strong network of clinics and other safety-net providers exists throughout the state. Not only will patients receive immediate care at this event, but they also will be connected to this network that can offer them care on an ongoing basis.”

In 2008, free clinics across the nation provided care to about 4 million uninsured people, including 175,000 in Georgia. In 2009, that doubled to about 8 million people, despite a decline in donations. A $1 donation to free clinics typically provides $5 worth of services.

“It is important to note that being uninsured is not the same as being unemployed,” Lamoureux said. “About 83 percent of uninsured people have jobs. At past C.A.R.E. Clinics, we found that many of the patients worked at two or more jobs but did not receive health insurance benefits. Some even worked as nurses or for insurance companies but still did not have insurance themselves.”

Volunteers can register now for shifts between 9:00 a.m. and 5:00 p.m. on March 26, when the clinic will be set up, and between 7:00 a.m. and 7:00 p.m. on March 27.

Medical volunteers needed for the Atlanta clinic include doctors of medicine, doctors of osteopathy, nurse practitioners, physician’s assistants, registered nurses, licensed vocational nurses, emergency medical technicians, medical administrators, licensed clinical social workers and more. Non-medical volunteers are needed to help with documentation, logistical support, patient intake and translation, as well as to be patient greeters and escorts. Help also is needed for setting up the clinic, as well as breaking it down.

Information for volunteers is available online at http://www.regonline.com/Atlanta_CARE_Clinic, as well as at http://freeclinics.us or http://www.gfcn.org. Those interested in appointments for patients at the clinic may call 1-277-233-5159 to sign up now.

Piedmont Physicians Group Welcomes Julio Schwartzman, M.D., CMD, RMM, MRO

Piedmont Physicians Group (PPG) welcomes Julio Schwartzman, M.D., CMD, RMM, MRO, to its healthcare team beginning Thursday, April 1. Dr. Schwartzman will be practicing at Piedmont Physicians at East Ellijay located at 97 Hefner Street, Suite 202, Ellijay, Ga., and will be joined by his physician’s assistant, David Sprinkle, PA-C.

Dr. Schwartzman earned his medical degree from the University Of Guadalajara School of Medicine. He then completed his internship in internal medicine at Franklin Square Hospital Center in Baltimore, Md., and his residency in family practice at Social Security Hospital in Aguascalientes, Mexico. He is board-certified in internal medicine and a registered medical manager.

Prior to joining PPG, Dr. Schwartzman practiced at Laurel Medical Center in Ellijay, Ga. He is the treasurer of the Georgia Medical Director’s Association and also serves as the current medical director for Twelve Oaks Hospice in Ellijay.

Joining Dr. Schwartzman will be his physician’s assistant, David Sprinkle, PA-C., who earned his master’s degree in medical science from Emory University in Atlanta, ranking first in his class. Sprinkle earned his bachelor’s degree from Citadel and was a captain in the U.S. Marine Corps.

“Dr. Schwartzman has more than 30 years of experience in providing top quality healthcare,” said Berney Crane, CEO of Piedmont Medical Care Corporation, the administrative parent corporation of the Piedmont Physicians Group. “He is a man of many talents and we are excited to have such a professional in the Piedmont Healthcare family.”

Dr. Schwartzman accepts most forms of insurance. Office hours are Monday through Friday from 8 a.m. to 7 p.m. and Saturdays from 10 a.m. to 2 p.m. To schedule an appointment, please call 706-635-1400. For more information visit www.piedmontphysicians.org.
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