Blue Cross Blue Shield of Georgia Is Skimping on Mental Health Care, Says Georgia Psychological Association

/PRNewswire / -- Late in 2007, Blue Cross Blue Shield of Georgia (BCBSGa) announced that it was cutting its hourly therapy reimbursement rate for clinical psychologists by approximately 19%. This new rate is about the same as you pay your auto mechanic or home handyman per hour.

However, unlike your mechanic, BCBSGa wants to pay licensed psychologists about half of what they were paid 10 years ago by BCBSGa. In 1998 clinical psychologists were reimbursed by BCBSGa nearly one and a half times today's rate for the same therapy hour. Accounting for inflation, today's rate should be nearly double in 2007 dollars (US Bureau of Labor Statistics based on the Consumer Price Index). Unlike medical doctors and dentists, psychologists see only one patient per hour.

As a result, GPA is hearing from its members that more and more licensed psychologists, especially the most experienced, are finding they can no longer see patients insured with BCBSGa insurance because they cannot run a practice, much less make a living, on what BCBSGa, one of Georgia's largest insurers, is willing to reimburse psychologists

Effective treatment requires highly specialized training and experience. Clinical psychologists licensed in the state of Georgia have either a Ph.D. or a Psy.D. including a bachelor's degree, 4-6 years post-graduate work, plus 1 year supervised internship, and at least one year post-doctoral supervision by a licensed psychologist.

"Research has shown again and again that there is a connection between good physical health and good mental health," said Georgia Psychological Association past-president, Dr. Joni Prince. "And taking a pill alone is not usually the most effective way of improving mental health; psychotropic drugs work better when used in conjunction with psychotherapy," she continued.

But clinical psychologists feel pressured to defend themselves if they see their BCBSGa patients for more than the "licensure type average" of 6.0 sessions, even though BCBSGa offers its PPO customers 50 therapy sessions per calendar year. Major depression, can affect almost 9% of the American population (Mann, New England Journal of Medicine, 10/27/05), and is a leading cause of lost productivity and time off from work. "It seems that Blue Cross is basing treatment decisions on statistics rather than clinical information," Prince said.

What else should you know?

In addition to psychotherapy, psychologists are the only mental health professionals who are qualified to administer, score, and interpret psychological testing instruments, including psycho-educational testing (for IQs, learning disabilities, etc.) and neuropsychological testing, among others.

Yet BCBSGa routinely denies coverage to its customers for psychological evaluations. Evaluations and accompanying clinical interviews are the first step in either diagnosing or ruling out learning disabilities, ADHD, Depression, Anxiety, Bi-polar disorder and other psychopathology. Nearly half (45%) of those with any mental disorder meet criteria for two or more disorders (National Institute of Mental Health press release related to a study published in September 2006 issue of the American Journal of Psychiatry).

Without proper evaluation, mental disorders will go undiagnosed and therefore, untreated. For instance, among adults who have an anxiety disorder about half had symptoms of some type of diagnosable mental illness by age 15, an NIMH-funded study showed. The results emphasize the importance of early diagnosis and treatment of anxiety disorders (NIMH Science Update 2/7/07). "In spite of these studies, many of which are publicized, patients are neglecting their mental health in part due to poor coverage and limited access to quality mental health care," Dr. Prince continued.

Once your child is diagnosed, for example, with Autism or Asperger's, his or her treatment may not be covered by BCBSGa, depending on the type of policy. This flies in the face of Georgia Law, which considers both Autism and Asperger's to be neurological conditions, all of which are mandated by law to be covered equally by insurers (GA Code 33-24-59.10).

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Federal Health Architecture Delivers Free, Scalable Solution Helping Organizations Tie Health IT Systems into the NHIN

The Federal Health Architecture is making software available as a first
step to help public and private health information technology systems
communicate to the Nationwide Health Information Network (NHIN), a
federal initiative to facilitate the electronic exchange of health
information. The Federal Health Architecture, an E-Gov initiative led
by the Office of the National Coordinator for Health Information
Technology (ONC), is making this free software, called CONNECT, and
supporting documentation available at www.connectopensource.org.

The ONC has facilitated development of the NHIN, which will tie together
health information exchanges, integrated delivery networks, pharmacies,
government health facilities and payors, labs, providers, private payors
and other stakeholders into a "network of networks." The NHIN provides a
mechanism for previously disconnected systems and exchanges to connect
to each other and share data. The NHIN uses interoperability standards
recognized by the Secretary of Health and Human Services, as well as
public and private sector specifications, participation agreements and
policies. To enable health information exchanges over the NHIN, the ONC
is working to develop the necessary governance processes and legal
framework for participation in the network.

"This software will strengthen our health systems' ability to share data
electronically and provide a wide range of benefits to citizens," said
Robert Kolodner, M.D., National Coordinator for Health Information
Technology. "Benefits include up-to-date records available at the point
of care; enhanced population health screening; and being able to collect
case research faster to facilitate disability claims, as demonstrated by
transfers of information already underway between the Social Security
Administration and MedVirginia, a regional health information
organization."

The CONNECT software is the outcome of a 2008 decision by more than 20
federal agencies to connect their health IT systems to the NHIN. Rather
than individually building software required to make this possible, the
federal agencies, through the Federal Health Architecture, created
CONNECT. This shared software solution can be used by each agency within
its own environment. CONNECT implements the core services defined by the
NHIN including standards for security to protect health information when
it is exchanged with other trusted health organizations.

The agencies built CONNECT using open source components, and will make
it available under an open source license in order to encourage
innovation and to keep costs low. CONNECT will be available to the
entire health care industry, which is expected to speed NHIN adoption
among health care organizations.

"Federal agencies accomplished something remarkable in developing
CONNECT. They looked beyond their individual needs to the needs of the
group as a whole, and they collectively built a solution that provides
benefit to all involved much faster and at a significantly reduced cost
than if they had worked independently," said Dr. Kolodner. "Not only did
the agencies deliver a valuable product for use in the federal
government, CONNECT is now an option for any public or private sector
organization that wants to use the solution in the future to tie into
the Nationwide Health Information Network when it goes into full
production."

The Department of Defense, the Department of Veterans Affairs, the
Social Security Administration (SSA), the Centers for Disease Control
and Prevention, the Indian Health Service, and the National Cancer
Institute have tested and demonstrated CONNECT's ability to share data
among one another and with private sector organizations. In February
2009, the CONNECT software gateway was used for the first time in a
limited production environment when the SSA began receiving live patient
data from MedVirginia through the NHIN.

"Delivering CONNECT has been an enormous project, and we still have a
lot of work to do to move us to large-scale production usage. But with
the support of the federal agencies and industry, we can accomplish the
lofty health IT goals set at the national level," commented the Federal
Health Architecture's program director Vish Sankaran.

Private and public sector organizations can download CONNECT and use it
for their connectivity needs. As with other open source solutions,
organizations are encouraged to modify and expand the capabilities of
the software. Although the download is free, an organization opting to
use the solution should be aware it will be responsible for costs
associated with its implementation and maintenance within its own
environment.

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Governor Praises Passage of Legislation to Restructure the Department of Human Resources

Governor Sonny Perdue commended today the final passage of House Bill 228 by the General Assembly. This legislation will reorganize the Department of Human Resources (DHR) and the Department of Community Health, creating a new Department of Behavioral Health. The legislation was introduced in House by Rep. Mark Butler and carried in the Senate by Sen. Renee Unterman.

“House Bill 228 provides vital restructuring to agencies that care for our state’s most vulnerable citizens,” said Governor Perdue. “I am confident this restructuring puts in place a framework for a more efficient, effective delivery of these critical services.”

The bill will result in three agencies reorganized to provide more focused results – the Department of Behavioral Health and Developmental Disabilities, the Department of Community Health and the Department of Human Services. The Department of Behavioral Health and Developmental Disabilities will be responsible for all mental health, developmental disability and addictive disease programs currently under DHR. The department will report directly to the Governor, increasing transparency.

The Department of Community Health will be reorganized to include all the public health and health and long-term care regulation programs of DHR. This change establishes one lead agency to focus on improving Georgia’s health and streamlines health related activities currently in two separate departments.

Lastly, remaining services will be housed under the Department of Human Services. Programs included in this department include Aging, Division of Family and Children Services (DFCS) and Child Support.

The bill largely resembles the recommendations made by the Health and Human Services Task Force, which convened last year and studied these issues at length. Sen. Renee Unterman, Sen. Jack Hill, Rep. Ben Harbin and Rep. Mark Butler all served on the Health and Human Services Task Force.

“With the passage of this legislation, we are transforming Georgia’s mental and public health systems,” said Rep. Butler. “Georgians who might be lost in a larger organization will get the help and attention they need and deserve.”
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Mayo Clinic and IBM Host Medical Language Initiative

Biomedical informatics researchers at Mayo Clinic and IBM today launched a Web site for the newly founded Open Health Natural Language Processing (NLP) Consortium. The consortium is establishing the open-source space to promote past and current development efforts, including participation in information extraction from electronic medical records.

As part of the launch, Mayo Clinic and IBM released their clinical NLP technologies into the public domain. The site http://www.ohnlp.org will allow the approximately 2,000 researchers and developers working on clinical language systems worldwide to contribute code and further develop the systems.

"We are inviting our international colleagues to help continue development of these valuable tools," says Christopher Chute, M.D., Dr.P.H., Mayo Clinic bioinformatics expert and senior consultant on the project. "By making it an open-source initiative, we hope to enable wide use of these NLP tools so medical advancements can happen faster and more efficiently."

"The recently passed American Recovery and Reinvestment Act promises to accelerate the adoption of electronic medical records," said Dan Pelino, IBM's general manager, Global Healthcare & Life. "Because the success of such reform rides on delivering interconnected and intelligent information to health care professionals everywhere, Mayo and IBM are tapping into the collaborative power of the open-source community to speed the development of Natural Language Processing (NLP). Adoption of this technology will provide physicians with insights into each patient's condition, allowing them to electronically retrieve the exact knowledge they seek from patient health records rather than reading through every record provided, as they must do today." Patient privacy is a main concern and consideration; all current and any future required safeguards and regulations will be adhered to strictly.

NLP is a relatively new and specialized area within computer science dealing with computational methods for understanding human language. In medicine, clinical NLP systems process the vast repositories of text generated by patient-clinician interactions. Such systems categorize and structure it according to standard nomenclature — in this case focusing on terms used in a range of medical specialties — that will ultimately speed data searches for both diagnoses and medical research. These NLP platforms or "pipelines" aid indexing and searching electronic medical records within institutions to quickly find similar cases or conditions, so physicians are not reliant solely on their own clinical experience in analyzing a problem. Researchers may also use these tools to aid retrospective epidemiological studies or do groundwork for new clinical trials.
"Large-scale information extraction from the clinical narrative is a vital component in advancing translational research and patient care," adds Guergana Savova, Ph.D., medical informatics specialist and Mayo's NLP lead on the project. "It 'unlocks' the clinical textual data that resides in huge repositories. Such technology would allow for large-scale data aggregation, analyses and usage — just imagine the power of data from millions of patients."

"There is a treasure trove of historical unstructured data that provides essential information for the study of disease progression, treatment effectiveness and long-term outcome which NLP systems make available to clinicians and researchers," states Anni Coden Ph.D., IBM's NLP principal on the project. "Such data can provide guidance for prospective studies and furthermore facilitate the integration of data from multi-modal data sources."

As an increasing percentage of health care and academic medical centers adopt electronic medical records, searching and extracting information from them in an automated fashion becomes essential. Mayo Clinic and IBM jointly developed a system for extracting information from more than 25 million free-text clinical notes based on IBM's open-source Unstructured Information Management Architecture (UIMA). As part of the system, developers build strings of "annotators" that become a pipeline, allowing physicians to mine the text for references of specific conditions, drugs, diseases, signs and symptoms; anatomical areas or organs; or treatment procedures. IBM and Mayo Clinic also developed a system to extract cancer disease characteristics from unstructured pathology reports to facilitate "consistent retrieval and transmission of cancer cases." The system extracts tumor characteristics, lymph node status and metastatic disease information enabling the automatic computation of cancer stage, which is critical to determine optimal treatment.

The two clinical text solutions released open-source by Mayo Clinic and IBM aim at processing two specific types of notes. Clinical notes describe patient-physician encounters, while pathology reports center around tissue findings. Both options are already adding value for Mayo and its patients:

Physicians can research past records to examine earlier cases of rare conditions, thereby "conferring" with their colleagues across time to aid diagnosis and treatment decisions.
Retrospective studies of tissue samples can propel new research findings, as happened with a major breast cancer finding at Mayo in 2008.

Enhanced ability to mine data and determine potential study factors or participants has already enabled individualized medicine treatments in psychiatric care.

Mayo's open-source solution, clinical Text Analysis and Knowledge Extraction System (cTAKES), focuses on processing the patient-centric clinical notes. Its low level components, for example the software that discovers sentence and word boundaries, assigns words part-of-speech tags and forms phrases out of the words, are "trained" to understand clinical language. The higher-level information extraction components, for example the ones that determine which textual spans are highly relevant to the clinical meaning of a note, are specifically designed for this domain. cTAKES has the functionality to recognize whether a clinical concept is negated, relevant to the patient or to the patient's family, which are attributes critical to understanding patient-centered medical language.

IBM's medKAT systems (medical Knowledge Analysis Tool) is a UIMA-based, modular and flexible system that uses advanced NLP techniques to extract structured information from unstructured data sources, such as pathology reports, clinical notes, discharge summaries and medical literature. medKAT/P is a version customized for the pathology domain, based on a representation of cancer, its characteristics and disease progression. The system recognizes concepts such as primary tumor and its associated attributes (e.g. histology, anatomical site, etc.) or lymph node status and its associated attributes (e.g. number of positive and excised nodes) by identifying mentions (e.g. histology or anatomical sites) and their relations (including negation). medKAT can be viewed as a development platform that is adaptable to user and domain requirements. It has been designed to operate within institutional systems or databases of any size.

Participants: information about the Open Health Natural Language Processing Consortium can be found at http://www.ohnlp.org with links to Source Forge downloads. The UIMA framework is available at http://incubator.apache.org/uima/.

For more information about IBM, visit http://www.ibm.com.
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Governor Perdue Commends the Passage of ‘Access to Flu Vaccines Act’

Governor Sonny Perdue announced today the final passage of House Bill 217, the “Access to Flu Vaccines Act”, by the General Assembly. The bill was introduced by Representative Jimmy Pruett, one of the Governor’s floor leaders in the House. The legislation improves Georgians’ ability to receive a flu shot.

“The flu affects thousands of people each year and our citizens should be able to access flu vaccines to protect themselves and their families,” said Governor Perdue. “With this legislation it will be easier for Georgians, especially vulnerable populations like children and the elderly, to receive their yearly flu shot.”

The “Access to Flu Vaccines Act” will allow physicians to enter into protocol agreements with pharmacists and registered nurses to allow the ordering and dispensing of flu shots without a physician’s individual prescription. To ensure quality control, physicians may issue no more than 10 standing orders with pharmacists and nurses within the same county or adjacent county to the physician’s primary place of business. Corporations with more than one location are also included in this agreement. This includes grocery stores and drug stores.
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U.S. Adults 'Needlessly Vulnerable' to Vaccine-Preventable Diseases, According to New Report

/PRNewswire/ -- Fifty thousand American adults die every year from vaccine-preventable diseases. Hundreds of thousands more are hospitalized and miss work because of infections that could be prevented with vaccines. Yet, most Americans continue to think of vaccines as benefiting only children, not adults.

In an effort to raise awareness about the importance of the adult immunization schedule, the National Foundation for Infectious Diseases (NFID), with support from the nation's leading health organizations, has issued a Call to Action to improve low vaccination rates among adults. Most adults are not protected against vaccine-preventable diseases, leaving them vulnerable to long-term suffering that could result in a high price tag for society.

To help educate the public, healthcare providers and the media, NFID launched a new comprehensive Web site on the importance of adult vaccination at www.adultvaccination.com. The Web site includes critical information on 13 adult diseases and the vaccines recommended to protect against them. The Call to Action also is available for download on the Web site.

"Vaccines are as crucial to our long-term health as are screenings for certain cancers. Unfortunately, many adults associate vaccinations with childhood, or assume influenza is the only vaccine they need," said William Schaffner, MD, President-Elect of NFID and chairman of the Department of Preventive Medicine at Vanderbilt University School of Medicine. "Vaccines are currently available to protect adults against many serious illnesses, but they are significantly under-used, elevating the risk of illness and even death."

NFID announced its Call to Action and online resources at an Interactive Online Scientific Symposium on April 2, 2009, which provided an in-depth medical briefing on recommended adult vaccines and the power of immunity.

"Unfortunately, adult vaccines are not on patients' radar. Increased education is needed to help ensure adults understand the importance of vaccination and know which vaccines they should receive. Healthcare providers also must commit to recommending vaccination for their adult patients," said Susan J. Rehm, MD, NFID Medical Director and Vice Chair of the Department of Infectious Disease at Cleveland Clinic. "Bottom line - it is a public health imperative to protect more adults from vaccine-preventable diseases."

Saving Lives: Integrating Vaccines for Adults into Routine Care

NFID's Call to Action, "Saving Lives: Integrating Vaccines for Adults into Routine Care," was developed based on dialogue with top health organizations, including the American College of Obstetricians and Gynecologists, American College of Physicians, American Medical Association, Centers for Disease Control and Prevention and Infectious Diseases Society of America. The Call to Action emphasizes the impact that vaccine-preventable diseases have on adults, and the benefits of vaccination for individuals and the community at large.

The Call to Action highlights barriers to immunization and presents practical strategies that can be used to improve adult vaccination rates, including:

-- Increasing awareness of the adult immunization schedule; communicating
who should be vaccinated and when.
-- Educating individuals about their potential for spreading disease
among family/friends if they remain unvaccinated.
-- Making adult immunization a part of routine patient care; discussing
vaccines with all patients and immunizing at all opportunities (well,
sick and follow-up visits).
-- Prompting patients to ask about vaccines and prompting healthcare
providers to adopt processes to ensure patient immunizations are up to
date.


AdultVaccination.com Provides Tools and Information for the Public and Medical Professionals

NFID's new adult vaccination Web site (www.adultvaccination.com) is a comprehensive resource on adult vaccine-preventable diseases for the general public, healthcare providers and the media. Content includes disease-specific resources and important prevention information, including which vaccines adults should receive, and the top ten reasons to get vaccinated.

Resources for healthcare providers include tools to assist in improving adult vaccination rates, such as reminder postcards and phone scripts, patient education materials, and sample standing orders for a variety of diseases and vaccines. Information for the media includes backgrounders on adult vaccine-preventable diseases and downloadable graphics.

Select materials are also available in Spanish.

Impact of Adult Vaccine-Preventable Diseases

Approximately 50,000 American adults die every year from vaccine-preventable diseases. Millions more miss work, cannot care for those who depend on them and risk passing their infections on to others. Yet, a 2008 NFID consumer survey on adult immunization found a significant knowledge gap and lack of concern about vaccination. For example, 40 percent of respondents said because they had vaccines as a child, they did not need them again, and more than one-third (34 percent) reported a lack of concern about catching vaccine-preventable diseases.

The burden of many adult vaccine-preventable diseases in terms of cost and lives lost is high. For example:

-- Influenza kills an average of 36,000 people annually and is associated
with over $10 billion in costs with a moderately severe seasonal
outbreak.
-- Pertussis, with an estimated one to three million cases each year, can
lead to pneumonia and exposure of infants, who are at greatest risk of
death from pertussis.
-- Pneumococcal disease, which causes pneumonia and invasive infections,
kills approximately 5,000 annually.
-- HPV infects more than 6 million females per year; two HPV strains
included in the vaccine cause 70 percent of all cervical cancers.
-- Shingles will affect one in three Americans in their lifetime. The
accompanying severe pain syndrome (post-herpetic neuralgia) may last
months or years after the shingles rash heals.
-- Hepatitis B-related liver disease kills about 5,000 Americans and
costs $700 million annually.

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Groundbreaking Research Begins for Pancreatic and Lung Cancers

/PRNewswire/ -- Georgia Tech and Saint Joseph's Hospital have joined together to begin the first regional research program to study the genetics and cell biology of pancreatic cancer. Tissue and serum samples from patients with cancer are being scrutinized to identify the differences in genetic and cellular features between normal and tumor cells. Findings from this research will be used for the ultimate purpose of developing tests for early diagnosis and identifying specific, targeted therapies to treat pancreatic cancer.

"The traditional treatment philosophy of 'one size fits all' is quickly becoming obsolete," says George Daneker, MD, the Medical Director of Oncology Research at Saint Joseph's Hospital and co-principal investigator of the study. "No two individuals are alike nor are two cancers; each is unique based on genetic and protein makeup."

Working with John McDonald, PhD, Chair of the School of Biology at Georgia Tech, and based on the research strategies from the acclaimed work of Dr. McDonald and Benedict Beningo, MD, with ovarian cancer patients, the current research is the first to focus on pancreatic cancer, accepted to be the most fatal of common cancers. Pancreatic cancer is similar to ovarian cancer in that it often goes undetected until the disease is too far advanced for curative therapy.

Dr. McDonald, recognized as a world authority in molecular genetics and genomics and Dr. Daneker, a surgical oncologist with an extensive background in basic and translational research, are applying state-of-the-art technologies toward identifying aberrant molecular and cellular mechanisms. Using microarray technology, gene expression patterns in pancreatic tumor tissue are compared with those present in the normal pancreas tissue. Microarray technology allows examination of more than 20,000 genes in a single experiment. Differences in the expression of genes encoding cellular proteins are of special interest with regard to the development of specific treatments.

There is also interest in the molecular basis of chemotherapy resistance. Some tumors respond very well to chemotherapy while others acquire resistance. By comparing the gene expression patterns in tumors that have become resistant to chemotherapy with patterns of these same tumors prior to chemotherapy, the research team hopes to identify the genes which mediate resistant. Identification of the mechanisms of resistance could lead to the development of treatment strategies that overcome the resistant pathways, making all tumors more responsive to treatment.

The research efforts will also focus on screening and early detection. By using a powerful analytical tool called mass spectrometry, coupled with data analysis using a "super-computer," the group hopes to identify patterns of molecular expression unique to cancer patients. This can lead to a sensitive screening test that only requires one drop of blood to run.

"Georgia Tech has the most advanced technology and the scientists who can help move these 'bench' research projects closer to 'bedside' treatments for patients at a very rapid rate," says Daneker. "Saint Joseph's brings the clinical expertise to take the treatments directly to the patient faster. It's a very unique partnership that facilitates rapid discovery and satisfies both our missions to bring the best treatments to patients in the quickest, safest way."

Saint Joseph's and Georgia Tech plan on expanding the collaborative research to lung cancers in April, as well as to prostate and colorectal cancers in the following months.

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FDA Approves Generic Topamax to Prevent Seizures

The U.S. Food and Drug Administration has approved the first generic versions of Topamax tablets (topiramate) to prevent seizures.

"Generic drugs undergo a rigorous scientific review to ensure they will provide patients with the same dose of high quality, safe and effective active ingredient as the name brand product," said Gary Buehler, director of the Office of Generic Drugs in the Center for Drug Evaluation and Research. "The FDA is committed to providing access to safe and effective generic drugs as soon as the law permits when a brand name drug’s patents and exclusivities expire."

Topiramate tablets in several different strengths have been approved to be marketed by the following firms: Roxane Laboratories Inc., Par Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Barr Laboratories Inc., TEVA Pharmaceuticals USA, Ranbaxy Laboratories Ltd., CIPLA Ltd., Glenmark Generics Ltd., Cobalt Laboratories, Apotex Inc., Zydus Pharmaceuticals USA, Aurobindo Pharma Ltd., Torrent Pharmaceuticals Ltd., Invagen Pharmaceuticals Inc., Unichem Laboratories Ltd., Sun Pharmaceuticals Ltd. and Pliva Hrvatska.

Prescribing information, or labeling, for generic topiramate will differ from the innovator drug, Topamax, because some uses of Topamax continue to be protected by patents and exclusivity.

The labeling for Topamax and generic topiramate contains an important safety warning about metabolic acidosis, a condition associated with excessive acid in the blood, which can cause symptoms such as tiredness, loss of appetite, irregular heartbeat, and impaired consciousness. Health care professionals should perform a blood test to monitor the level of a patient’s serum bicarbonate.

The use of topiramate has been associated with serious eye problems, such as a sudden decrease in vision and a blockage of fluid in the eye causing increased pressure in the eye. Patients taking topiramate should contact their health care professional immediately if they have a loss in vision or experience eye pain. These problems can lead to blindness if not treated right away.

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FDA Approves Drug for an Advanced Form of Kidney Cancer

The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies.

Renal cell cancer, the most common type of kidney cancer, originates in the lining of the small tubules in the kidney that filter waste products from the blood. The cancer is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has spread to other parts of the body.

"Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib or sorafenib," said Robert Justice, M.D., director, Division of Drug Oncology Products in the FDA's Center for Drug Evaluation and Research. "Targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing."

Afinitor belongs to a class of drugs called kinase inhibitors, which interfere with cell communication, preventing tumor growth. The drug is intended for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, Sutent (sunitinib) or Nexavar (sorafenib).

While Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets), Afinitor works by blocking a specific protein known as the mammalian target of rapamycin or mTOR. The protein blocking action disrupts the growth, division and metabolism of cancer cells.

A clinical trial studying the safety and effectiveness of Afinitor was discontinued after an interim analysis showed that, in patients receiving the drug, the growth or spread of the tumor was delayed when compared to patients who did not receive the drug. In addition, disease progression was delayed approximately five months in half of the patients who received Afinitor. In contrast, disease progression was delayed two months in patients who did not receive the drug.

The most frequent adverse reactions in the trial (occurring in at least 20 percent of patients) included inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever. Laboratory tests of blood samples determined that at least half of all patients experienced anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar.

Afinitor is manufactured by Novartis International AG of Basel, Switzerland. Sutent is manufactured by Pfizer Inc. of New York. Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany.

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FDA Approves New Vaccine to Prevent Japanese Encephalitis

The U.S. Food and Drug Administration today approved IXIARO, a vaccine to prevent Japanese encephalitis (JE) which is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO will be the only vaccine for JE available in the United States.

"This vaccine offers protection for individuals who travel to or live in areas where outbreaks are known to occur," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.

In Asia, JE affects about 30,000 to 50,000 people each year, resulting in 10,000 to 15,000 deaths. JE is rarely seen in the United States, with very few cases reported among civilians and military traveling from the United States to Asia.

The virus that causes JE affects membranes around the brain and mild infections can occur without apparent symptoms other than fever and headache. In people who develop severe disease, JE usually starts as a flu-like illness but can worsen, causing high fever, neck stiffness, brain damage, coma, or even death. The disease is transmitted via infected mosquitoes; it is not spread from human to human.

IXIARO is a second-generation JE vaccine,in that itis manufactured using cell culture technology leading to improved manufacturing efficiency as well as more reliable control of the vaccine manufacturing process. This technology utilizes an established bank of cells that can be drawn from at any time contributing to the assurance of consistent vaccine quality.It also enhances the ability to rapidly manufacture a vaccine on a large scale if needed, without compromise to the vaccine's safety or effectiveness.

Clinical studies were conducted in more than 800 healthy men and women in the United States and Europe. Participants received either IXIARO or JE-VAX, another U.S.-licensed vaccine that is no longer being manufactured. The studies found that IXIARO produced sufficient levels of antibodies in the blood to protect against JE. IXIARO requires two doses instead of JE-VAX's three.

The vaccine was well tolerated and the most commonly reported adverse events were headache, muscle pain and pain, swelling, and tenderness at the injection site. Overall, it was more tolerable and had fewer side effects than the comparator, JE-VAX.

IXIARO is manufactured by Intercell Biomedical, Livingston, U.K.

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FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs

The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.

The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.

Those companies receiving warning letters are Boehringer Ingelheim Roxane, Inc., Columbus, Ohio; Cody Laboratories, Inc., Cody, Wyoming; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Company, Inc., Philadelphia; Lehigh Valley Technologies, Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.

The warning letters are part of the FDA's initiative on marketed unapproved drugs announced in June 2006. At that time, the agency published a compliance policy guide describing its risk-based enforcement approach against illegally marketed unapproved drugs.

"Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."

Consumers who rely on narcotics for pain relief continue to have access to narcotic products that the agency has evaluated and determined to be safe and effective. The FDA has determined that removal of the unapproved narcotic products will not create a shortage for consumers.

Consumers who may be concerned that they are taking any of these products should refer to the FDA's Unapproved Drugs Web page, which includes a list of manufacturers of these products. These consumers should consult a health care professional for detailed guidance on treatment options.

"We will continue to take aggressive action against those firms that do not have the required FDA approval for their drugs," said Deborah M. Autor, J.D., director of CDER's Office of Compliance. "Today's warning letters are another demonstration of our commitment to remove illegal, unapproved drugs from the market."

Manufacturers have 60 days to stop manufacturing these products. Distributors have 90 days to stop shipping existing products. Previously manufactured products may still be found on pharmacy shelves for a short time.

To view copies of the Warning Letters, the names of the companies and their affected products, see the FDA's Unapproved Drugs Web page at:
http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm#narcotics

Information on FDA-approved drugs: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Drugs Marketed in the United States That Do Not Have Required FDA Approval:
http://www.fda.gov/cder/drug/unapproved_drugs

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UGA to Host Stem Cell Therapies for Spinal Cord Injuries Workshop April 4

Following President Barack Obama's decision to lift the ban on federal funding for embryonic stem cell research, medical and scientific experts will converge at the University of Georgia to discuss how recent advances in stem cell research can be turned into cures for spinal cord injuries.

The second Spinal Cord Workshop, a program of the Bedford Stem Cell Research Foundation, will be held on Saturday, April 4 from 8:30 a.m. to 5:30 p.m. at the Paul D. Coverdell Center for Biomedical and Health Sciences in Athens, Ga.

Every year close to 11,000 people sustain spinal cord injuries in the United States, while more than 200,000 Americans live each day with a disability caused by them.

“Because spinal cord injury usually occurs in otherwise healthy, young adults, it is an especially attractive candidate for a cure for stem cell therapy,” said Ann Kiessling, director of the Bedford Stem Cell Research Foundation. “The big question is whether a ‘moon shot’ approach will produce a cure, or if there is still too much basic science yet unknown.”

The workshop is hosted by UGA’s Regenerative Bioscience Center. Additional support is provided by the UGA Biomedical and Health Sciences Institute, the Shepherd Center in Atlanta and Millipore, Inc.

“The University of Georgia is fortunate to team up with the Bedford Foundation to host these leading experts in spinal cord therapies to discuss and develop new paths forward for spinal cord injuries,” said Steven Stice, director of the Regenerative Bioscience Center and a UGA College of Agricultural and Environmental Sciences professor. “In addition, Georgia’s recent legislation aimed at restricting stem cell research makes this workshop an especially timely one.”

Created in 1996, the Bedford Stem Cell Research Foundation is a Massachusetts-based public charity and biomedical institute conducts stem cell and related research for diseases and conditions that currently have no cure.

The Regenerative Bioscience Center brings UGA’s expertise, resources and accomplishments in human embryonic stem cell research under one umbrella, while contributing to the university’s educational and outreach missions with student research experiences and public lectures, symposia and workshops.

The event serves as a follow-up to the inaugural Spinal Cord Workshop held at UGA in March 2008. For more information, go to the Web site www.spinalcordworkshop.org.

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Closing Open Heart Surgery: Saint Joseph's Performs Georgia's First Totally-Closed, Beating Heart Bypass Surgery

/PRNewswire/ -- Patients facing open heart surgery for coronary artery bypass or valve repairs just got some great news: open heart surgery doesn't have to be open anymore.

Sudhir P. Srivastava, MD, a cardiothoracic surgeon at Saint Joseph's Hospital in Atlanta and the world leader in performing beating heart, totally-endoscopic, coronary artery bypass surgery, has started performing the procedures in Georgia.

"Dr. Srivastava performed the first-in-Georgia procedure on Friday, March 20 and the patient was released on Sunday, March 22," says Kirk Wilson, president and CEO of Saint Joseph's Hospital.

"With robotic assistance, Dr. Srivastava performed the single coronary artery bypass through four small, dime-sized incisions reducing the patient's recovery time, trauma to the body and risk of infection."

Dr. Srivastava is one of the world's most experienced cardiac robotic surgeons and has performed nearly 1000 robotic cardiothoracic surgical procedures since 2002. Three hundred and fifty have been singe and multi-vessel (two, three and four vessel), beating heart, totally-endoscopic coronary bypass procedures (TECAB). TECAB is done through four or five fingertip-size incisions and associated with functional recovery in days rather than months compared to the other traditional approaches. Dr. Srivastava has numerous world's firsts in robotic and minimally-invasive cardiac surgery and has unmatched expertise in obtaining bilateral internal mammary arteries using the robotic surgical system.

"This TECAB procedure for obtaining the mammary arteries is the gold standard of treatment for patients," says Dr. Srivastava. "The benefits are proven: faster recovery, less scarring, reduced risk of infection and a faster return to normal living."

With the addition of Dr. Srivastava to Saint Joseph's robotics program, cardiac patients have a choice of 'closing' open heart surgery for most procedures.

Dr. Srivastava performed a double bypass procedure on Monday, March 23 and that patient also was able to be discharged two days later on March 25, much sooner than the typical five - seven day hospital stay required for traditional open procedures.

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Georgia State Researcher Investigates Link Between Folic Acid and Heart Health, Anemia

A Georgia State University researcher and his colleague are investigating the effects of a decade-long requirement to fortify all cereals in the United States with folic acid, and its link with a chemical believed to play a role in cardiovascular disease.

Vijay Ganji, associate professor of nutrition in Georgia State’s College of Health and Human Sciences, and Mohammad R. Kafai, of San Francisco State University, investigated multiple factors involved in the levels of the nutrient folic acid and homocysteine — for which studies suggest a link to increased risk for cardiovascular disease.

The report is one of the first examining factors such as gender, race, blood pressure, and levels of certain chemicals in the blood during the post-fortification period. Ganji and Kafai examined the data from the National Center for Health Statistics’ National Health and Nutrition Examination Survey from 1999 to 2004.

Since 1998, all processed cereals in the United States have been fortified with folic acid in an effort to help prevent neural tube defects — a type of birth defect that can lead to neurological diseases such as spina bifida, a defect resulting in an incomplete spinal cord.

Folic acid fortification has reduced the risk of neural tube defects by up to 20 percent in the United States, and by higher levels in Canada, which started fortification at about at the same time, Ganji explained.

But an unintended effect of fortification is the reduction of homocysteine — a chemical which studies suggest increases the risk of cardiovascular disease, decreased cognitive function and bone mineral density. Fortification has helped reduce homocysteine levels in the population.
Not everyone needs high levels of folic acid. The intended target for fortification is women who are pregnant or are of child-bearing age, and not necessarily men, children or the elderly.

In the study, Ganji and Kafai found an association between homocysteine levels and serum methylmalonic acid, or MMA — which can indicate vitamin B12 deficiency, a factor in certain types of anemia.

“MMA and vitamin B12 are both coming out to be a strong predictor of homocysteine,” Ganji said. “What might be happening is the worsening of B12 deficiency symptoms.”

The paradox is that folic acid fortification has had the unintended effect of reducing the risk for anemia. It is possible that certain B12 deficiency symptoms may be masked.

“When you give folic acid to someone with B12 deficiency, the anemia coming from the lack of B12 might be cured and patient does not feel tired due to lack of anemia, hence less likely to see the physician, but the neurological symptoms of the deficiency may be worsened,” Ganji explained.

Still, the enormous benefits of folic acid fortification cannot be discounted.

“It has been positive so far, and has resulted in significant reductions in neural tube defects, as well as homocysteine,” Ganji said. "We must have an ongoing public policy evaluation, though, to see if there are any trends or changes among the population.

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FDA: Insulin Pens and Insulin Cartridges Must Not Be Shared

The U.S. Food and Drug Administration today issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses.

Insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge. The devices typically contain enough insulin for a patient to self-administer several doses of insulin before the reservoir or cartridge is empty. All insulin pens are approved only for single-patient use (one device for only one patient).

The FDA is aware of incidents at two undisclosed hospitals involving more than 2,000 people in which the cartridge component of the insulin pens were used to administer insulin to multiple patients, although the disposable needles were reportedly changed among patients.

“Insulin pens are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection,” said Amy Egan, M.D., deputy director of safety at the FDA’s Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research. “Insulin pens are not designed, and are not safe, for one pen to be used by more than one patient, even if needles are changed between patients due to the risk of transmitting blood-borne pathogens.”

Patients exposed to shared insulin pens are being contacted by the two hospitals and are being offered testing for hepatitis and HIV. Some of the potentially exposed patients have reportedly tested positive for the hepatitis C virus, although it is not known if the virus was spread as a result of insulin pen sharing.

The FDA is working with the Centers for Disease Control and Prevention and professional organizations to address infection control issues related to insulin pens.

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