Piedmont Newnan Hospital Receives Generous Donation

$5.1 million gift is largest in Piedmont Healthcare history.

The Piedmont Newnan Hospital replacement facility on Poplar Road will offer enhanced services in the areas of interventional radiology, surgery, emergency care and women’s and neonatal services thanks to a major boost from Newnan Hospital Inc.  Newnan Hospital Inc. (NHI) has made a historic gift valued at over $5.1 million to Piedmont Newnan Hospital, the largest, private, one-time gift in Piedmont Healthcare’s 105-year history.    

Newnan Hospital Inc. is the legal entity that was the previous owner of Piedmont Newnan Hospital and continues today with a mission to support healthcare-related needs and initiatives to improve the healthcare of the local community.

“We are building a new hospital today because of the vision and perseverance of the Newnan Hospital Inc. Board of Directors,” said Michael Bass, president and CEO of Piedmont Newnan Hospital. “This transformational gift demonstrates loud and clear Newnan Hospital Inc.’s longstanding commitment to improving healthcare for all citizens of Coweta County. We sincerely thank the board for this most generous gift.”

The gift includes $4 million of enhancements and additions, previously not programmed into the scope of the replacement hospital. A major portion of the funds will purchase medical equipment in interventional radiology services and will enable the build-out of two additional surgical suites, including one with enhanced capabilities for urological procedures. The additional rooms will improve scheduling and availability of surgery and other procedures for patients and doctors.

In addition, it will provide further enhancements to the emergency department, including multi-purpose, ceiling equipment booms in the trauma rooms to keep the floors clear of diagnostic equipment; a faster, 64-slice CT scanner; and critical care monitors compatible with future technology.  Additionally, pediatric and infant resuscitation equipment and infant warmers will be purchased for exclusive use in the emergency department, rather than be shared with the labor and delivery unit.  For women’s and neonatal services, the donation will allow the provision of dedicated NICU incubators with resuscitation capability in all rooms, including delivery rooms.

In making the announcement, Tom Moat, president of the Newnan Hospital Inc. Board of Directors, expressed the board’s feeling on how important it is for NHI to be involved in providing the best possible hospital for residents of the Coweta community.

 “Piedmont is going to provide our community with a new, state-of-the-art hospital, and we believe it is important for Newnan Hospital Inc. to take the lead in helping augment vital services in the new facility,” said Moat. “We can help provide enhanced services that will benefit all of us for many years.” 

“Having been in the hospital business for almost 90 years, our board recognizes that community support includes both using services available at our local hospital and supporting it financially,” added Moat. “We are grateful to Piedmont Healthcare for all they are doing by building a new hospital facility. We want to help through these donations and hope this will encourage others to support further development of the new hospital and advance healthcare in our community.”

The gift also includes the property on the court square in downtown Newnan, which serves as the Piedmont Newnan Hospital Wellness Center. Valued at $840,000, Piedmont Newnan Hospital will continue operating the downtown Newnan Wellness Center for the community.

The third element of the gift is an additional $260,000 set aside for the utilization of the original Newnan Hospital campus, located at 80 Jackson Street. This campus currently houses both the Piedmont Newnan Hospital Ambulatory Surgery Center and the Piedmont Heartburn Treatment Center. These services will be relocated to the new facility on Poplar Road, scheduled to open in the spring of 2012.

“This gift from Newnan Hospital Inc. represents the largest one-time gift in Piedmont’s history and sets the stage for fundraising efforts to support the new hospital,” said R. Timothy Stack, president and CEO of Piedmont Healthcare. “To the 500-plus annual donors who already support Piedmont Newnan Hospital, as well as our Auxilians and our community, this contribution makes a bold statement that through philanthropy, we have the ability to make a tremendous impact on the quality of local healthcare in the communities we serve.”

This gift is the largest in a series of recent gifts made by NHI to benefit healthcare in Coweta County.  Earlier this fall, NHI announced a $2 million gift to University of West Georgia’s School of Nursing; a $1 million gift to West Georgia Technical College, benefiting the allied health sciences programs; and another $1 million contribution to the new Coweta Samaritan Clinic.
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Physician Coalition: "No Place for Big Government in Exam Room"

The Medical Association of Georgia (MAG) joined more than 100 doctors from across the country in Washington, D.C., today to offer legislators a “second opinion” on the best way to reform the nation’s health care system at a press conference that was sponsored by the Coalition to Protect Patients’ Rights.

“We need to reform our broken medical payment system, but a hurried approach that fails to protect the patient-physician relationship isn’t the answer,” said M. Todd Williamson, M.D., MAG’s immediate past president and spokesman for a coalition of state and national specialty societies that represents nearly 50,000 physicians. “There is no place for big government in our exam rooms.”

Of S.B. 1776 – which would have eliminated the Medicare Sustainable Growth Rate (SGR) payment cuts that are scheduled to go into effect on January 1, 2010 and that would have indefinitely frozen Medicare payment rates – Dr. Williamson said, “MAG supported the provisions that were included in Senate Bill 1776 that were designed to address the flawed SGR on an unconditional basis.”

Dr. Williamson added that tort reform represents a reasonable and proven way to reform the nation’s unsustainable medical payment system.

Dr. Williamson said that, “Our physician coalition group is encouraging Senate leaders to produce legislation that addresses the flawed medical payment system in a way that ensures that individual patients can control their own health care dollars and can consult with the physician of their choice as a trusted advisor in making the medical decisions that are best for them and their families.”

The Coalition to Protect Patients’ Rights is a non-partisan, grassroots coalition made of more than 10,000 doctors, health care providers, advocacy groups, and concerned citizens who are dedicated to the implementation of patient-centered health care reform that will improve patient care. It’s headed up by former American Medical Association President Donald J. Palmisano, M.D. Go to www.protectpatientsrights.org for additional information on the Coalition to Protect Patients’ Rights.

With more than 6,000 members, MAG is the leading voice for physicians in Georgia. Go to www.mag.org/nationalhealthcarereform/ for more information.
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Russian Health Care Delegation Hosted by Emory

A delegation of Russian healthcare workers are in Atlanta to learn about improving the outcomes of pregnancy through the Perinatal Health Care Delivery System, initiated in the State of Georgia by former President Jimmy Carter when he was Governor.

The arrival of the delegation to Emory University comes at a critical time as strategies for bilateral cooperation between the United States and Russia make headlines.

Recently, Emory Professor of Pediatrics Alfred W. Brann Jr. attended the Civil Society Summit in Moscow as a representative of the public health working group and helped draft the recommended areas for joint United States and Russian cooperation in the field of public health and medical science in the broad area of maternal and child health.

As director of the Atlanta-based World Health Organization/Collaborating Center in Reproductive Health (WHO/CC/RH), Brann has worked tirelessly to reduce infant and maternal mortality and improve perinatal care in some 30 countries over the last 25 years.

The visit of Russian healthcare delegation to Emory is co-sponsored by The Future of Russia Foundation, Emory University (Claus Halle Institute of Global Learning, the Center for Russian and East European Studies, Emory’s Center for Ethics and the World Health Organization Collaborating Centre for Reproductive Health) and the Rotary Club of Atlanta.

The collaborative educational program between Russian and American perinatal health care professionals will review previous mutual concerns in reproductive health; discuss the present status of these concerns; and determine the next steps in putting into action the Obama/Medvedev memorandum of understanding (MOU) in the field of maternal and infant healthcare.

Brann serves as medical director of the Future of Russia Foundation (FOR) - the only U.S. charitable foundation created for and solely committed to the mission of modernizing the Russian system for delivery of health care to women of reproductive age and infants, addressing Russia’s declining population, identified in then-President Putin’s inaugural address as Russia’s “greatest crisis.” Brann served in both capacities to lead the development of The Balashikha Project - a comprehensive model for modernizing perinatal care throughout Russia.

“The Russian population is declining some 700 000 people per year. We feel that the Balashikha Project and its potential for improving the outcomes of pregnancy will significantly improve the Russian population by creating new healthy births,” says Brann.

Over the past nine years through the Balashikha project, Russian health care providers have participated in four bi-lateral exchanges with Brann and his Atlanta based colleagues to share ideas and experiences with neonatalogists, pediatricians, obstetricians, nurses, midwives and public health professionals.

This collaborative effort enabled health experts to create a successful perinatal center within a hospital in Balashikha, made it a referral center for high-risk mothers and babies in the Moscow Oblast, and created a postgraduate education for perinatal health professions in that region. A perinatal surveillance system is currently being developed.

“We are trying to create a system of compassionate and evidenced care practices to improve every family’s chances for a healthy pregnancy outcome where the mother and infant are alive and normal following childbirth,” says Brann.
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MHA Director McIlwain Prepared for the Challenges of the Health Care System

As health care remains on the front burner of political debate, the Master of Health Administration (MHA) program at Clayton State University is prepared to continue its mission of developing well-rounded competent individuals for administrative positions in varying types of health care organizations. The new director of the MHA program, Dr. Thomas F. McIlwain, is prepared for the challenges in a changing health care system.

“Change is inevitable, and the health care system is no exception,” he says. “In my 25 or so years of working and teaching in health services administration, I have seen the problems, issues, health policies, and health policy outcomes debated. Each new policy change is a tweak of the existing system, but each has been designed to make it better. I have no doubt of the outcome of the current debate. The system will get a little better.”

McIlwain comes to Clayton State with a wealth of prior industry and teaching experience. In the 80s, he served as an administrative associate at University Hospitals of Alabama while teaching in the MSHA program at the University of Alabama at Birmingham, where he received his Ph.D. in Health Services Administration. His administrative residency was with a for-profit system, American Medical International, which eventually merged with National Medical Enterprises to form what is now know as Tenet Health Care.

His immediate teaching position after UAB was at Appalachian State University in the Walker College of Business’ Department of Management. He served as director of the undergraduate health care management program for eight of the 10 years he was in Boone, N.C. He then moved to Mount Pleasant, S.C., where he served as MHA program director for three of the 10 years he was on faculty at the Medical University of South Carolina.

For the past four years he was associate professor of Public Health and vice-chair in the Department of Community Health Sciences in the College of Health at the University of Southern Mississippi in Hattiesburg. While there, he developed the graduate emphasis in health administration in the CEPH-accredited Master of Public Health program. He was also involved in the development of the cohort-based Executive Master of Public Health in Health Services Administration program.

McIlwain has consulted with health care organizations in the area of strategic planning including medical group practices, nursing homes, and hospitals. His research interests are in health care marketing, including direct-to-the-consumer pharmaceutical advertising, and health care strategic management.

“The main goal of the MHA program at Clayton State is to become CAHME (the Commission on Accreditation of Health Management Education) accredited. CAHME is dedicated to promoting, evaluating, and improving graduate healthcare management education. I was responsible for the re-accreditation of the MHA program at MUSC where the program received the highest awarded number for seven years,” McIlwain says. “My goal is to move this program to that level of quality education. This process will involve making sure that we have quality admissions, support, and outcomes in teaching, service, and research. We are moving the program to competency based outcome measurement also.

“I was attracted to Clayton State because of its proximity to the health care industrial complex of the Metro Atlanta area. This program is poised to become a premier provider of graduate health care management education in the Atlanta and Georgia region. My experience with accreditation and program management provides me with a perspective of what this University can accomplish in this type of program”McIlwain is looking forward to accomplishing many goals within MHA program.

“The goals of the program are to prepare students for positions of increased responsibility within healthcare organizations. It also provides individuals with clinical backgrounds the management skills needed to assume leadership positions,” he says. “We are also interested in attracting individuals who have experience in other industries but want to begin careers in health care management.

“Of course the goal of all health administration programs is to improve the quality of care and resource use in health organizations by graduating individuals with the skills and competencies to achieve this goal.”
McIlwain is married to Margaret, a family nurse practitioner, and is the father of two sons.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
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Community Hospitals: Dying Breed or Community Cornerstone?

/PRNewswire/ -- In the widespread discussion of universal health insurance and soaring medical costs, one of America's most cherished traditions -- the hometown community hospital -- has been largely forgotten.

Many analysts suggest that small community hospitals are especially vulnerable -- with smaller populations, limited services, and small medical staffs. Yet their value is unquestioned. A 2007 AHA study on The Economic Contribution of Hospitals documented the importance of hospitals to communities beyond healthcare, with each hospital job supporting two additional jobs, and goods and services purchased by hospitals creating additional economic value.

Yet while governmental attention focuses largely on cost controls and insurance for all, Atlanta- based Hospitalogic(TM), a family of companies providing physician services, consulting and hospital management, is championing change to ensure their viability for future generations.

"Our vision is for financially successful community hospitals across America," says Hospitalogic CEO Jim Burnette. "We believe it is attainable by approaching the challenge differently."

Financial distress, rooted in the late 1990's when Medicare and commercial insurers systematically reduced prices paid to hospitals and physicians, turned the industry revenue model upside down, causing pressures. This transformation caused most hospitals to struggle, with nearly 80% having lost money at some point over the last 5 years.

Although propped up by such Federal programs as Critical Access Hospital reimbursement, reduced revenues and rising costs squeezed profits or caused losses for many -- triggering financial deterioration and hospital closures impacting hundreds of communities since 2000.

Viewing soaring costs and reduced reimbursements as symptoms rather than causes of the problems, Hospitalogic's leadership has owned, re-opened, and operated small community hospitals -- pioneering new approaches and achieving profitability while doing so.

"We know what it takes to succeed, and our methodology is proven. We've sat in the Board member's and CEO's chair, negotiated with lenders, met payrolls and worked with regulators," states Burnette. "We take on transformation projects without regard to condition because we understand first-hand the difficulties hospitals face."

In 2000, Hospitalogic purchased and reopened Tattnall Memorial Hospital in Reidsville, Georgia. The hospital continues to operate successfully today in a service area with a population of 18,000.

For-profit North Oak Regional Medical Center in Senatobia, Mississippi had lost money for 10 straight years and was within days of closing when Hospitalogic took over in 2002. Within 18 months, the hospital was at break-even. By 2004, the organization's unique emergency and inpatient medical practice had achieved a 936% return on investment, with profitability continuing annually since.

Sometimes the distress call comes too late, admits Burnette. Hospitalogic successfully re-opened a community hospital in Brownsville, Pennsylvania in 2008, overcoming regulatory and financial hurdles. Yet the hospital closed nine months later following a multimillion judgment against the hospital's board dating to the facility's prior ownership.

"America needs successful community hospitals," Burnette adds. "They are essential to community success. With passion and the right approach, it can be done."

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Sen. Judson Hill (GA): All Health Care Reform is Not Created Equal

With Democratic control of both the White House and Congress, national health care reform has a better chance of passing now than any time in recent history. Americans agree that change in our health care system is necessary. Escalating health care and insurance premiums are unsustainable for most families, businesses and all levels of government. Every day it becomes more and more evident that all health care reform is not created equal.

Conservatives have worked for years to change the fundamentals of health care and health care financing to achieve a patient centered, prevention focused, free market system. Many moderates and liberals want government-based health care reform in which the government provides for everyone and health care is “free.” National leaders are advancing numerous reform proposals. Yes, America needs health care reform, but be careful which version you ask for because as the saying goes, “choose your rut in the road carefully since you’ll be in it for the next 100 miles”.

Political experts today will tell you that some sort of health care reform will pass. Any national health care reform measures that survive the political hurdles necessary to become law will be very difficult to change in the future. You and I have a vested interest in which reform proposal actually becomes law.

Early free market successes have begun in several states. These conservative initiatives offer healthier outcomes, stabilized costs, and tax savings and incentives for individual responsibility. For example, Georgia law now incentivizes people to choose healthy behaviors by actually allowing health insurance companies to partially refund premiums to people who stay healthy. But to date, no insurance company has refunded premiums. It’s time we ask them why not?

Three simple conservative steps would improve health care, lower costs and reduce the number of people without health insurance. First, all insurance should be owned by the individual so your financial security and health care coverage is not at risk just because you left your job and lost your company’s insurance. Second, everyone should be able to pay for health care and health insurance with before tax dollars. And third, we should reward personal responsibility and healthy choices with lower insurance premiums.

Governments can and should transform their health care programs. Taxpayers cannot afford to expand and sustain Medicare and Medicaid programs. Instead millions of dollars can be saved by allowing qualified, lower income earners to use their government health care assistance subsidy as a scholarship to buy private health insurance through their employer. In most cases this is a much less expensive option that provides better and more accessible health care. Under such a plan, physician reimbursements for government programs are higher and state taxpayers would save millions of dollars.

If America chooses a national more socialized plan similar to government plans in Western Europe, there will be a huge price to pay. The consequences of this choice are monumental and long-term. European and Canadian health care is characterized by delayed treatments, rationing of care, exorbitant taxpayer costs and sometimes the loss of life. In these countries people with higher incomes purchase private insurance to get to the” head of the line” for better treatment for themselves and their families. Those who chose to buy private insurance continue to pay much higher taxes for national care to cover everyone else. Europeans and Canadians even come to the U.S. to find better health care with easier access for treatment, and yet our government wants to put forth a similar government plan.

Earlier this year the Obama Administration and the Democrat controlled Congress quickly rushed through billions of government spending in the federal “stimulus” bill. Health care reforms cannot be rushed. Health care delivery and financing is too complex. Although Democrats in Congress may have the votes, now is not the time to “just pass” health care reform legislation and then fill in the blanks later. This is not the time to experiment. The details matter too much because lives are at risk.

As we work toward health care reform, everyone should answer three questions and then call their representatives. “What type of reform do you want - patient centered or government centered?” “Should our government be in the health care business or should we incentivize physician-patient relationships?” And finally, “Which health care reform measure encourages and incentives personal responsibility for your health?” Your answers to these questions are vital because if you think health care is expensive now, just wait until you see the costs when it is “free.”
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HHS Issues Second Report on Personalized Health Care

HHS Secretary Mike Leavitt today released the second report from his
Initiative on Personalized Health Care, examining the potential for new
findings in genetics and other molecular-level medicine to improve the
quality and cost-effectiveness of health care.

The report, "Personalized Health Care: Pioneers, Partnerships,
Progress," includes reports from 10 institutions where personalized
health care techniques are beginning to be used. It also includes seven
commissioned papers examining the opportunities and challenges for
personalized health care from the perspectives of different stakeholders
in the health care sector.

"These sample case studies reflect a broad scope of approaches that are
already being tried, as well as partnerships for achieving higher levels
of effectiveness and personalization in health care," Secretary Leavitt
writes in a "Prologue" chapter in the report.

Personalized health care envisions medical care that is increasingly
differentiated between patients based on variations in their individual
biology. For example, differences in metabolism or other factors cause
a given prescription medication to work well with some individuals, but
not others. By measuring such individual variations in patients before
prescribing, drugs could be used more safely, effectively and at lower
cost.

Genetic and molecular medicine should also help spot diseases before
symptoms appear, enabling treatments to delay or preempt the disease and
avoid costly late-stage treatments. Personal genomic profiles may also
enable patients to learn their particular predisposition to disease and
take more effective disease prevention steps.

Secretary Leavitt says in the report that the potential for personalized
health care techniques to improve health and increase value in health
care make personalized health care a factor that should be targeted as
part of any plan to reform the nation's health care system. In
addition, current models of paying for health care, which reward volume
of care over value or quality, may hinder promising new avenues that
would avoid expensive late-stage treatments or prevent disease.

Secretary Leavitt launched his special Initiative on Personalized Health
Care in 2006. The report is available at www.hhs.gov/myhealthcare.

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FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs

The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease. Bayer Women's is also labeled for use in "fighting" osteoporosis. Neither product has been approved by the FDA for such uses. These drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC).

"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."

Bayer Heart Advantage combines aspirin and phytosterols in a single tablet. Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug. According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol and the calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis. Although certain calcium-containing dietary supplements may bear claims to reduce the risk of osteoporosis, products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval. Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease. Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.

Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling and formulation, as well as the indications (uses) for which the drugs can be marketed. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. Bayer Heart Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. Therefore, Bayer Heart Advantage and Bayer Women's are unapproved new drugs.

In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are misleading. Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits. The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.

"The marketing of these unapproved drugs is troubling," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."

Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.

Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States.

Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products.

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FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs. The Web page, http://www.fda.gov/cder/drugSafety.htm, provides links to information in these categories:

* Drug labeling, including patient labeling, professional labeling, and patient package inserts;
* Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits outweigh their risks;
* A searchable database of postmarket studies that are required from, or agreed to by, drug companies to provide the FDA with additional information about a drug's safety, efficacy, or optimal use;
* Clinicaltrials.gov, a searchable database of clinical trials, including information about each trial's purpose, who may participate, locations, and useful phone numbers;
* Drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts;
* Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA's Adverse Event Reporting System (AERS);
* Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
* Regulations and guidance documents;
* Consumer information about using medications safely and disposing of unused medicines;
* Instructions how to report problems to the FDA through its MedWatch program;
* Consumer articles on drug safety; and
* The FDA's response to the Institute of Medicine's 2006 report on the future of drug safety.

"By placing Web links to these up-to-date resources on a single page, we're helping consumers and health care professionals find drug safety information faster and easier," said Paul Seligman, M.D., M.P.H., associate director of Safety Policy and Communication in the FDA's Center for Drug Evaluation and Research. "This type of communication is aimed at helping consumers and health care professionals make well-informed decisions about medication use."

Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007, and is among FDA's many efforts to address the safe use of drugs throughout their lifecycle.

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80 Georgia Lawmakers to Meet with Trauma Care Specialists Monday

80 Georgia lawmakers to meet with trauma care specialists Statewide briefing on trauma care on Monday, September 29 is free and open to health care providers, business and community leaders, educators, and the media at the Georgia Railroad Freight Depot in downtown Atlanta

More than 80 Georgia legislators will meet next Monday, September 29, with dozens of trauma care professionals, other health care providers, and active stakeholders to brief government and the public on the status of the Georgia statewide trauma care system. Some 118 state lawmakers have signed on as hosts and supporters of this project, and they are working to develop a permanent funding source.

The Trauma Care in Crisis statewide briefing is expected to draw several hundred participants to the Georgia Railroad Freight Depot in downtown Atlanta for the luncheon forum from 10 AM till 1 PM.
The event is free and open to health care professionals and others interested in trauma care.

Topics covered by speakers and panelists will include an overview of the statewide trauma system, legislation, preparedness, the regional approach, communication, business, funding, and prevention.

Speakers representing major hospitals, emergency medical services (EMS), universities, the Governor's Office of Highway Safety, and business organizations will present a variety of perspectives on how to establish and fund a comprehensive statewide trauma care system to serve all the people of Georgia.

The briefing is sponsored by Healthcare Georgia Foundation, a non-profit grantmaking institution that has funded a series of roundtables and forums facilitated by Atlanta-based Reece & Associates, a group that specializes in public policy and government relations.

Register online now > or call Christine Jordan at (404) 586-2100.
_________________________________________

About Healthcare Georgia Foundation
Healthcare Georgia Foundation is a statewide, private independent foundation. The Foundation's mission is to advance the health of all Georgians and to expand access to affordable, quality healthcare for underserved individuals and communities. Through its strategic grantmaking, Healthcare Georgia Foundation supports organizations that drive positive change, promotes programs that improve health and healthcare among underserved individuals and communities, and connects people, partners and resources across Georgia.

For more information, please visit the Foundation online at www.healthcaregeorgia.org

Emory Begins Testing New Alzheimer's Disease Vaccine

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For more information, call the Emory Alzheimer's Disease Research Center at 404-728-6950.
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PIEDMONT HOSPITAL URGES GEORGIA WOMEN TO GET SCREENED

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

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

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

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

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

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