FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C

The U.S. Food and Drug Administration yesterday sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.

Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company:

* To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and
* Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.

Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed.

The FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.

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Hot Shots! TRICARE Makes H1N1 Immunizations Easy for Beneficiaries

Immunizations against the H1N1 virus will soon be available, and people are eager to take precautions. TRICARE Prime, Standard and Extra beneficiaries can get their shots from network and non-network providers without paying a deductible or making a co-payment. A temporary waiver allows non-active duty TRICARE Prime enrollees to get the H1N1 immunization from non-network providers without a referral or authorization, eliminating point-of-service charges. Prime enrollees will not be charged a co-payment or cost share.

Active duty service members should follow the guidance of their respective services.

“Preventive medicine is a very important part of TRICARE’s goal of keeping service members, retirees and families healthy,” said Rear Adm. Christine Hunter, deputy director of the TRICARE Management Activity. “To that end, we make getting vaccinated as convenient and affordable as possible. Beneficiaries should talk to their primary care manager if they have any questions about the H1N1 vaccine or other vaccines.”

According to the Centers for Disease Control and Prevention (CDC), the vaccine for the seasonal flu is not expected to protect against H1N1; immunization for the 2009 H1N1 strain is therefore recommended. Both vaccines can be administered on the same day.

CDC’s Advisory Committee on Immunization Practices recommends that everyone get the H1N1 vaccine, but for certain groups vaccination is more critical. These include:

• Pregnant women;
• People who live with or care for children younger than 6 months;
• Healthcare and emergency medical services personnel;
• Everyone between the ages of 6 months and 24 years;
• People ages 25 through 64 with chronic health disorders or compromised immune
systems; and
• Older people with diabetes, cardiovascular disease, asthma or HIV.

For more information on H1N1 and other seasonal flu conditions, beneficiaries should contact their primary care manager or visit the TRICARE Web site at http://tricare.mil/flu, or go to the Department of Defense Pandemic Influenza Watchboard at http://fhp.osd.mil/aiWatchboard/index.jsp.

About TRICARE Management Activity and the Military Health System
TRICARE Management Activity, the Defense Department activity that administers the health care plan for the uniformed services, retirees and their families, serves more than 9.5 million eligible beneficiaries worldwide in the Military Health System (MHS). The mission of the MHS is to enhance Department of Defense and national security by providing health support for the full range of military operations. The MHS provides quality medical care through a network of providers, military treatment facilities, medical clinics and dental clinics worldwide.

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HHS Strengthens HIPAA Enforcement

The U.S. Department of Health and Human Services (HHS) issued an interim final rule with request for comments today to strengthen its enforcement of the rules promulgated under the Health Insurance Portability and Accountability Act (HIPAA). The Health Information Technology for Economic and Clinical Health (HITECH) Act, which was enacted as part of the American Recovery and Reinvestment Act of 2009, modified the HHS Secretary's authority to impose civil money penalties for violations occurring after Feb. 18, 2009. These HITECH Act revisions significantly increase the penalty amounts the Secretary may impose for violations of
the HIPAA rules and encourage prompt corrective action.

Prior to the HITECH Act, the Secretary could not impose a penalty of more than $100 for each violation or $25,000 for all identical violations of the same provision. A covered health care provider, health plan or clearinghouse could also bar the Secretary's imposition of a civil money penalty by demonstrating that it did not know that it violated the HIPAA rules. Section 13410(d) of the HITECH Act strengthened the civil money penalty scheme by establishing tiered ranges of increasing minimum penalty amounts, with a maximum penalty of $1.5 million for all violations of an identical provision. A covered entity can no longer bar the imposition of a civil money penalty for an unknown violation unless it corrects the violation within 30 days of discovery.

The interim final rule with request for comments published today conforms the HIPAA enforcement regulations to these revisions made by the HITECH Act. It may be viewed and commented on at: www.regulations.gov. This rulemaking will become effective on Nov. 30,
2009, and HHS will consider all comments received by Dec. 29, 2009.

"The Department's implementation of these HITECH Act enforcement provisions will strengthen the HIPAA protections and rights related to an individual's health information," said Georgina Verdugo, the director of HHS Office for Civil Rights (OCR). OCR is responsible for
administering and enforcing HIPAA's privacy, security and breach notification rules.

"This strengthened penalty scheme will encourage health care providers, health plans and other health care entities required to comply with HIPAA to ensure that their compliance programs are effectively designed to prevent, detect and quickly correct violations of the HIPAA rules,"
said Verdugo. "Such heightened vigilance will give consumers greater confidence in the privacy and security of their health information and in the industry's use of health information technology."

This interim final rule with request for comments is the first of several steps HHS is taking to implement the HITECH Act's enforcement provisions. The remaining provisions, which have yet to become effective, will be addressed in the next few months in forthcoming rulemakings.

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Public Seminar for Alzheimer’s Caregivers Co-Hosted by Emory

A group of experts will gather in Atlanta on Thursday, Nov. 5 to discuss caring for a person with Alzheimer’s disease. Presenters at the evening seminar, "Practical Strategies: Caring for a Loved One with Alzheimer’s,” will cover topics including managing daily life, planning future decisions, handling crises, dealing with family and caring for yourself. Members of the public are invited to attend and participate in a Q&A session with panelists.

The seminar is sponsored by the Emory University Alzheimer’s Disease Research Center, the Georgia chapter of the Alzheimer’s Association and the Fulton County Human Services Department, Office of Aging

The event will be held from 5:30 p.m. to 7:30 p.m. at the Helene Mills Senior Center located at 515 John Wesley Dobbs Ave., Atlanta, Ga., 30312. Admission and parking are free. Beverages and light snacks will be provided. For more information, please call (404) 523-3353.

Presenters/Topics Include:

Dr. Angela Ashley
Director, Grady Memory Assessment Clinic
Assistant Professor, Emory University School of Medicine

Shileah Cantey
Diversity Outreach Coordinator, Alzheimer's Association

Dr. Adriana Hermida
Assistant Professor, Emory University School of Medicine

Miles Hurley
Elder Care Law Attorney

Moderator: Dr. Ken Hepburn
Emory University School of Nursing
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HHS Secretary Sebelius Announces Senate Confirmation of Dr. Regina Benjamin as U.S. Surgeon General

U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius announced Thursday that the United States Senate unanimously confirmed Dr. Regina Benjamin as the nation’s Surgeon General.

"Dr. Benjamin will quickly become America's doctor as our next Surgeon General. Her deep knowledge and strong medical skills, her commitment to her patients, and her ability to inspire the people she interacts with every day will serve her well as Surgeon General," said Secretary Sebelius. "She will be an integral part of our H1N1 response effort, and America can expect to see her very soon communicating important information about how to stay healthy and safe this flu season. I commend the Senate for their unanimous vote, and I look forward to working with Dr. Benjamin in the days ahead."

A brief biography of Dr. Benjamin is below:

Dr. Regina M. Benjamin, Surgeon General, Department of Health and Human Services
Regina M. Benjamin, MD, MBA, is Founder and CEO of the Bayou La Batre Rural Health Clinic in Bayou La Batre, Alabama. She is the Immediate Past-Chair of the Federation of State Medical Boards of the United States, and previously served as Associate Dean for Rural Health at the University of South Alabama College of Medicine. In 2002, she became President of the Medical Association of the State of Alabama, making her the first African American woman to be president of a State Medical Society in the United States. Dr. Benjamin holds a BS in Chemistry from Xavier University, New Orleans. She was in the 2nd class at Morehouse School of Medicine and received her MD degree from the University of Alabama, Birmingham, as well as an MBA from Tulane University. She completed her residency in family medicine at the Medical Center of Central Georgia. Dr. Benjamin received the Nelson Mandela Award for Health and Human Rights in 1998, and was elected to the American Medical Association Board of Trustees in 1995, making her the first physician under age 40 and the first African-American woman to be elected. Dr. Benjamin was previously named by Time Magazine as one of the "Nation's 50 Future Leaders Age 40 and Under.” She was also featured in a New York Times article, "Angel in a White Coat", as "Person of the Week" on ABC's World News Tonight with Peter Jennings, and as "Woman of the Year" by CBS This Morning. She received the 2000 National Caring Award which was inspired by Mother Teresa, as well as the papal honor Pro Ecclesia et Pontifice from Pope Benedict XVI. She is also a recent recipient of the MacArthur Genius Award.

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AHIP Statement on Affordable Health Care for America Act

/PRNewswire/ -- Karen Ignagni, President and CEO of America's Health Insurance Plans (AHIP), released the following statement today in response to the Affordable Health Care for America Act:

"The promise of health care reform has been that if you like your current coverage, you can keep it. We are concerned that this proposal will break this promise by increasing health care costs for families and employers across the country and significantly disrupting the quality coverage on which millions of Americans rely today.

"The lack of system-wide cost containment is a missed opportunity. Without a greater focus on health care costs, families and employers will not be able to afford coverage and health care costs will rise at a rate much faster than the overall economy is able to sustain.

"We share the concerns that doctors, hospitals, employers, and patients have all raised about the significant disruption a new government-run plan would have on the current health care system. A new government-run plan would bankrupt hospitals, dismantle employer coverage, exacerbate cost-shifting from Medicare and Medicaid, and ultimately increase the federal deficit.

"Estimates show that a government-run plan would cause millions of people to lose their current coverage. Moreover, massive Medicare Advantage cuts would cause millions of seniors to lose their Medicare Advantage coverage altogether, while millions more would face benefit cuts and higher out-of-pocket costs.

"Health plans strongly support comprehensive, bipartisan health care reform and have proposed sweeping insurance market reforms and new consumer protections to ensure that every American has guaranteed access to affordable health care coverage. Experience in the states has shown that insurance market reforms must be paired with an effective personal coverage requirement for these reforms to work. While this legislation recognizes the key linkage of market reforms and a personal coverage requirement, more needs to be done to ensure coverage is affordable and our health care system is sustainable.

"As the process progresses, health plans will continue to work to advance bipartisan legislation this year that will cover all Americans, make coverage more affordable, and improve quality."

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Physicians' Coalition Representative to Tell Congressional Leaders "No Place for Big Government in Exam Room"

M. Todd Williamson, M.D., the immediate past president of the Medical Association of Georgia (MAG) and the spokesman for a coalition of state and specialty societies that represents nearly 50,000 practicing physicians from across the U.S., will call for national health care reform that is “patient-centered” when he addresses the GOP Doctors Caucus in Washington, D.C., at 3:30 p.m. today.

Dr. Williamson will outline the coalition’s key principles, which include…

· Protecting the physician-patient relationship
· Protecting the patient’s right to choose their doctor
· Protecting the patient’s right to choose their health insurance
· Protecting the right of physicians and patients to privately contract
· Ensuring that quality determinations are made by physicians

Dr. Williamson will conclude his comments by stressing that, “There is no place for big government in our exam rooms.”

The “Hearing on Effects of Congressional Healthcare Proposals” will air live at http://www.ustream.tv/channel/health-caucus.

The GOP Doctors Caucus is chaired by Pennsylvania Rep. Tim Murphy, Ph.D., and Georgia Rep. Phil Gingrey, M.D. It is composed of 13 Republican members of Congress, all who have backgrounds in health care.

With more than 6,000 members, MAG is the leading voice for physicians in Georgia. Go to www.mag.org/nationalhealthcarereform for additional information.
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Updated NCCN Guidelines for Breast Cancer Discourages Prophylactic Mastectomy in Women Other Than Those at High Risk

/PRNewswire/ -- Despite a recent study finding that an increasing number of women who had cancer in one breast are opting to have the other breast removed, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology(TM) for Breast Cancer discourages prophylactic mastectomy in women except for those considered high risk. This recommendation is noted in the recently updated NCCN Guidelines for Breast Cancer along with a new regimen for adjuvant chemotherapy and recommendations for utilizing sentinel node mapping and excision in women with clinically negative lymph nodes.

In the updated NCCN Guidelines, it states that prophylactic mastectomy (the removal of a noncancerous breast) contralateral to a known unilateral breast cancer is not recommended except as outlined in the NCCN Guidelines for Genetics/Familial High-Risk Assessment: Breast and Ovarian and the NCCN Guidelines for Breast Cancer Risk Reduction. When prophylactic mastectomy is being considered, the NCCN Guidelines note that the small benefits must be balanced with the risk of recurrent disease from the known breast cancer, the psychological and social issues associated with bilateral mastectomy, and the overall risks of contralateral mastectomy.

The practice of removing noncancerous breasts to reduce the risk or prevent cancer has become increasingly common among women. A study recently published in the journal Cancer found that among women who had cancer in one breast, the number who opted to have the other breast removed, more than doubled from 1995 through 2005 in New York state. However, there is no data to demonstrate that having prophylactic mastectomy actually improves survival.

The NCCN Guidelines Panel suggests that high-risk women considering a prophylactic mastectomy should be evaluated by a multi-disciplinary team and counseled on the risks of the procedure.

Perhaps the most clinically important update to the NCCN Guideline is the removal of the recommendation for a full axillary lymph node dissection as an option for women with clinically negative lymph nodes. The updated NCCN Guidelines now recommend that women with stage one or two invasive breast cancer with clinically negative lymph nodes, undergo sentinel node mapping and excision provided they are being treated by a team of clinicians with experience in sentinel node biopsy.

Sentinel node biopsy is a diagnostic procedure used to determine whether breast cancer has metastasized to axillary lymph nodes (e.g., lymph nodes under the arm). Sentinel node biopsy requires the removal of only a few lymph nodes compared to a full axillary lymph node dissection, and may decrease the risk of lymphedema and pain associated with surgery.

Another important update to the NCCN Guidelines is the addition of a new regimen for adjuvant chemotherapy for invasive breast cancer. The NCCN Guidelines now include FEC [fluorouracil (Adrucil(R), Pfizer Inc.) / epirubicin (Ellence(R), Pfizer Inc.) / cyclophosphamide (Cytoxan(R), Bristol-Myers Squibb Company)] followed by weekly paclitaxel (Taxol(R), Bristol-Myers Squibb Company) as an option for adjuvant therapy, treatment given after surgery.

Although the incidence of breast cancer has increased steadily in the United States over the past few decades, breast cancer mortality appears to be declining suggesting a benefit from early detection and more effective treatment.

NCCN Clinical Practice Guidelines in Oncology(TM) are developed and updated through an evidence-based process with explicit review of the scientific evidence integrated with expert judgment by multidisciplinary panels of physicians from NCCN Member Institutions. The most recent version of this and all the NCCN Guidelines are available free of charge at NCCN.org.

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Piedmont Hospital’s Transplant Services Continues to Enhance Patient Care By Launching Satellite Offices throughout Georgia

Piedmont Hospital Brings Dalton Its First Transplant Clinic

Piedmont Hospital Transplant Services is pleased to announce the opening of a new satellite transplant clinic in Dalton, Ga., on Friday, October 23. This facility will support continued efforts to enhance patient access to transplantation evaluation and follow-up care with strategically located satellite clinics throughout the state of Georgia.

These area clinics will make access to care more convenient for those patients who live long distances from Piedmont Hospital in Atlanta and reduce the initial evaluation time for kidney transplant candidates from two days to one.

“We are pleased and privileged to bring Dalton its first transplant clinic, increasing access to services for transplant patients across north Georgia and southeastern Tennessee,” said Mark Johnson, M.D., program director of Piedmont’s Transplant Services. “This clinic will provide pre- and post-transplant care to end-stage kidney and pancreas patients.”

Piedmont’s first satellite clinic opened in Savannah, Ga., in December 2007, and a second clinic opened in Albany, Ga., in February 2009. Each clinic offers education classes for those interested in the advantages and risks of transplantation, provides extensive information about the costs of post-transplant medication and how one can plan to meet those costs. Initial candidate screenings will be performed by a transplant physician and/or nurse specialist, allowing patients with potential disqualifying issues to take corrective action before making an appointment for a full evaluation at the Piedmont Hospital Mason Transplant Clinic in Atlanta.

Piedmont Hospital has one of only two adult liver transplant programs and one of three kidney/pancreas transplant programs in Georgia.

The new satellite transplant clinic in Dalton is located at 1109 Burleyson Road, Suite 101 Dalton, GA 30720, and will initially offer services for those with kidney and pancreas disease. For more information on the Piedmont Hospital Transplant Services Dalton Satellite Clinic, call 888-605-5888.
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CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)

/PRNewswire/ -- CryoLife, Inc., (NYSE:CRY) , an implantable biological medical device and cardiovascular tissue processing company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.

The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group. CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial.

"Following our July 2009 CE Mark approval to distribute BioFoam in the EU, we now have approval to begin a clinical trial, a critical step forward in the process to gain FDA approval of BioFoam in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. He added, "We believe that BioFoam may hold tremendous promise for surgeons around the world and are excited by the early data published thus far."

CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Based on the number of liver and spleen procedures performed annually in the European Community, CryoLife estimates the annual European market opportunity for BioFoam to be approximately $30 million and more than $100 million worldwide.

Upon successful completion of the feasibility study, and subsequent FDA and DoD approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study will be conducted. It is currently anticipated that the pivotal investigation will enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.

The primary objective of the pivotal investigation will be to demonstrate a decrease in the time to achieve intraoperative hemostasis (a complex process that causes bleeding to stop) following open liver resection surgery in subjects receiving an application of BioFoam compared to a standard topical hemostatic agent. The secondary objectives of this investigation will be to compare time to hemostasis and the achievement of immediate hemostasis between the BioFoam group and the control group (a standard topical hemostatic agent) to demonstrate that BioFoam is at least equivalent in performance to the control group.

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FDA Approves New Treatment for Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.

Arzerra is approved for patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy.

CLL primarily affects people older than 50 and arises from a group of white blood cells known as B-cells that are part of the body’s immune system. Each year, about 16,000 people are diagnosed with CLL and about 4,400 people die from the disease.

Arzerra is a monoclonal antibody, a type of biotechnology product. Antibodies that occur in nature are produced by the immune system in response to invaders. Arzerra binds to a specific protein found on the surface of both normal and malignant B cells, making the cells more susceptible to immune system attack.

The product was approved under the FDA’s accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. Products may receive accelerated approval based on a surrogate endpoint, such as a reduction in the size of the tumor or decrease in the number of cancerous white cells or in an enlarged spleen or lymph nodes. These indirect measures for clinical outcomes are considered reasonably likely to predict that the drug will allow patients to live longer or with fewer side effects of a disease.

“The approval of Arzerra illustrates FDA's commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

The accelerated approval process requires further study of the drug. The manufacturer is currently conducting a clinical trial in CLL patients to confirm that the addition of Arzerra to standard chemotherapy delays the progression of the disease.

Arzerra's effectiveness was evaluated in 59 patients with CLL whose disease no longer responded to the available therapies.

The product’s safety was evaluated in 181 patients in two studies in patients with cancer. Common side effects included a decrease in normal white blood cells, pneumonia, fever, cough, diarrhea, lower red blood cell counts, fatigue, shortness of breath, rash, nausea, bronchitis and upper respiratory tract infections.

The most serious side effects of Arzerra are increased chance of infections, including progressive multifocal leukoencephalopathy (PML), a brain infection that is generally fatal. Patients at high risk for Hepatitis B should be screened before being treated with Arzerra. Patients with evidence of inactive hepatitis should be monitored for re-activation of the infection during and after completing treatment.

Arzerra is manufactured by London-based GlaxoSmithKline.

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Mayo Clinic Announces Visitation Policy Changes

To prevent the spread of H1N1 influenza to pediatric patients, Mayo Clinic has temporarily revised visitation policy in pediatric units. As of Monday, Oct. 26, only the parents or primary caregivers may visit pediatric patients.

"We know this presents an inconvenience for families and friends of our pediatric patients, but we believe it's most important to prevent the spread of H1N1 to our patients," says Randall Flick, M.D. "We will continue to evaluate the situation, and adjust the visitation policy as necessary."

For the latest information on H1N1 and seasonal influenza, visit http://www.mayoclinic.org/influenza/.

FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir for 2009 H1N1 Influenza for Certain Patients, Settings

The U.S. Food and Drug Administration announced today that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following reasons:

1. the patient is not responding to either oral or inhaled antiviral therapy, or
2. when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;
3. for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.

The FDA has reviewed the available scientific data and has concluded that the criteria for authorizing the emergency use of IV peramivir have been met.

There are no FDA-approved intravenously administered antivirals for the treatment of influenza. Peramivir is the only intravenously administered influenza treatment currently authorized for use under EUA for 2009 H1N1 infections.

The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization is revoked by the agency.

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HHS Awards $17 Million in a New National Initiative to Fight Health Care-Associated Infections

/PRNewswire/ -- HHS Secretary Kathleen Sebelius today announced the award of $17 million to fund projects to fight costly and dangerous health care-associated infections, or HAIs.

"When patients go to the hospital, they expect to get better, not worse," Secretary Sebelius said. "Eliminating infections is critical to making care safer for patients and to improving the overall quality and safety of the health care system. We know that it can be done, and this new initiative will help us reach our goal."

HAIs are one of the most common complications of hospital care. Nearly 2 million patients develop HAIs, which contribute to 99,000 deaths each year and $28 billion to $33 billion in health care costs. HAIs are caused by different types of bacteria that infect patients being treated in a hospital or health care setting for other conditions. The most common HAI-causing bacteria is methicillin-resistant Staphylococcus aureus, or MRSA. The number of MRSA-associated hospital stays has more than tripled since 2000, reaching 368,600 in 2005, according to HHS' Agency for Healthcare Research and Quality's (AHRQ) Healthcare Cost and Utilization Project.

Of the $17 million, $8 million will fund a national expansion of the Keystone Project, which within 18 months successfully reduced the rate of central-line blood stream infections in more than 100 Michigan intensive care units and saved 1,500 lives and $200 million. The project was originally started by the Johns Hopkins University in Baltimore and the Michigan Health & Hospital Association to implement a comprehensive unit-based safety program. The program involves using a checklist of evidence-based safety practices; staff training and other tools for preventing infections that can be implemented in hospital units; standard and consistent measurement of infection rates; and tools to improve teamwork among doctors, nurses and hospital leaders.

Last year, AHRQ funded an expansion of this project to 10 states. With additional funding from AHRQ and a private foundation, the Keystone Project is now operating in all 50 states, Puerto Rico and the District of Columbia. The new funding announced today will expand the effort to more hospitals, extend it to other settings in addition to ICUs, and broaden the focus to address other types of infections. Specifically, the new $8 million in funding will provide:

-- $6 million to the Health Research & Educational Trust for national
efforts to expand the Comprehensive Unit-Based Patient Safety Program
to Reduce Central Line-Associated Blood Stream Infections. The funding
will allow more hospitals in all 50 states to participate in the
program and expand the program's reach into hospital settings outside
of the ICU. The Health Research & Educational Trust will also use $1
million to support a demonstration project that will help fight
catheter-associated urinary tract infections.

-- $1 million to Yale University to support a comprehensive plan to
prevent bloodstream infections in hemodialysis patients.


AHRQ, in collaboration with the Centers for Disease Control and Prevention (CDC), also identified several high-priority areas to apply the remaining $9 million toward reducing MRSA and other types of HAIs. These projects will focus on:

-- Reducing Clostridium difficile infections through a regional hospital
collaborative.
-- Reducing the overuse of antibiotics by primary care clinicians
treating patients in ambulatory and long-term care settings.
-- Evaluating two ways to eliminate MRSA in ICUs.
-- Improving the measurement of the risk of infections after surgery.
-- Identifying national-, regional- and state-level rates of HAIs that
are acquired in the acute care setting.
-- Reducing infections caused by Klebsiella pneumoniae
Carbapenemase-producing organisms by applying recently developed
recommendations from CDC's Healthcare Infection Control Practices
Advisory Committee.
-- Standardizing antibiotic use in long-term care settings (two
projects).
-- Implementing teamwork principles for frontline health care providers.

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Consumer Watchdog Asks HHS to Repeal Rule Allowing Health Care Providers to Decide When Notification of Breached Electronic Medical Records is Needed

Consumer Watchdog Asks HHS to Repeal Rule Allowing Health Care Providers to Decide When Notification of Breached Electronic Medical Records is Necessary

/PRNewswire/ -- Consumer Watchdog today called on the Health and Human Services Department to repeal a rule that allows health care providers and insurers to decide whether consumers must be notified when the security of their electronic confidential health information has been breached.

In a letter to HHS Secretary Kathleen Sebelius the nonprofit, nonpartisan consumer advocacy group said the HHS regulation violated the intent of Congress when it charged the department with writing the rules requiring notification if electronic medical records are breached. Consumers must be notified whenever there is a breach of medical records, the group said.

The American Recovery and Reinvestment Act of 2009 (ARRA) requires notification if there is an "unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of such information." The act charged HHS with writing and implementing the rules. But HHS decided to interpret "compromises the security" of data to include a substantial harm standard.

"Under the HHS interpretation, if the breaching entity decides there is no significant risk of financial, reputation or other harm to the individual, the provider or health insurer never has to disclose that the sensitive information was used or disclosed in violation of the federal privacy rule," wrote John M. Simpson, consumer advocate. "In other words, the company responsible for protecting the sensitive data gets to decide if it needs to bother to tell anyone that sensitive health data was breached. This is simply outrageous."

Consumer Watchdog asked what prompted HHS to flout Congressional intent. "Could it be that Congress managed to fend off the pressures of the health care industry in passing ARRA only to have the lobbyists return to exert their influence on the rule making process?"

Read Consumer Watchdog's letter here: https://www.consumerwatchdog.org/resources/LtrSebelius102209.pdf

Consumer Watchdog noted that Rep. Henry Waxman, Rep. Charles B. Rangel, Rep. John Dingell, Rep. Frank Pallone Jr., Rep. Pete Fortney Stark and Rep. Joe Barton have written Secretary Sebelius protesting that the HHS rule violates Congressional intent. The Congressmen's letter said:

"The primary purpose for mandatory breach notification is to provide incentives for health care entities to protect data, such as through strong encryption or destruction methodologies and to allow individuals to assess the level of unauthorized use of disclosure of their information. Such transparency allows the consumer to judge the quality of a health care entity's privacy protection based on how many breaches occur, enabling them to choose entities with better privacy practices. Furthermore, a black and white standard makes implementation and enforcement simpler."

Read the Congressional letter here: https://www.consumerwatchdog.org/resources/LtrCongSebelius.pdf

Consumer Watchdog said that the Federal Trade Commission, charged with writing breach regulations for non-HIPPA covered entities such as Personal Health Records vendors like Google Health did not find any justification for introducing a "harm" standard. "The FTC remained true to Congressional intent and to promoting the public interest," the letter said.

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'Doc Buy' Fails as Physician Support for Health Care Overhaul Wanes - Shadow Bill Concealing $247 Billion in Health Costs Defeated

'Doc Buy' Fails as Physician Support for Health Care Overhaul Wanes - Shadow Bill Concealing $247 Billion in Health Costs Defeated in Critical Senate Vote

/Standard Newswire/ -- Patients First, A Project of Americans for Prosperity(tm) is praising the U.S. Senate's bipartisan rejection of the $247 billion so-called "Doc Fix" bill (S.1776) by a 53-47 margin.

Senate Majority Leader Harry Reid had attempted to hastily force the bill through the Senate to
simultaneously purchase the support of doctors in the larger health care legislative battle, while concealing the full cost of the health overhaul in a shadow bill.

Leader Reid had abruptly scheduled today's failed cloture vote to increase Medicare payments to doctors by $247 billion. The tricky tactic, which would also have required a vote to waive Senate budget rules, raised criticism since it would conceal the total cost of the health care plan being considered in Congress by splitting the overhaul into two separate bills. The Senate Finance Committee recently voted for a $904 billion plan, but the addition of this $247 billion bill would have pushed the total cost of the overhaul to well over $1.1 trillion, violating the White House's
pledge to keep the health care plan deficit neutral.

"The 53 Senators that voted against this hastily-crafted backroom health care deal deserve credit," said Phil Kerpen, policy director of Patients First. "Leader Reid's attempt to use outright deception and trickery to conceal the true costs of the attempted Washington takeover of health care has failed. Americans have the right to know the details of how government-forced health care would impact their access to quality affordable health care. Transparency and open debate, not backroom deals and legislative gimmicks, offer us a way forward towards real health care
reform."

The "Doc Fix" bill's defeat spells further trouble for the Obama Administration and Congressional Democrats as they court critical support from doctors for the controversial health care overhaul. A recent IBD/TIPP Poll of nearly 1,400 doctors found that two-thirds of
physicians oppose the reforms proposed by Congress. 45 percent of doctors said that enactment
would force them to consider retiring or abandoning their practice, and 67 percent anticipated fewer medical school applicants. Meanwhile, 65 percent of doctors believed that the plan would lead to lower-quality care for seniors and 71 percent said that it was impossible for government to insure 47 million more Americans while cutting costs and providing better quality care.

"America's doctors cannot be bribed into supporting legislation that will restrict patient choice, increase bureaucracy, defund Medicare for seniors, and drive costs so high that middle class taxpayers suffer," said Phil Kerpen. "Our nation's physicians want to care for their patients, and government should not stand in the way of the sacred doctor-patient relationship."

Patients First, A Project of Americans for Prosperity(tm), is focused on real health care reform--reform that puts patients first. Patients First believes that Americans want and need more health insurance options--not just a costly, government-defined plan paid for by American taxpayers.

Patients First is a project of Americans for Prosperity® (AFP), a 501(c)(4) non-profit organization recognized by the IRS. AFP is the nation's premier grassroots organization committed to advancing every individual's right to economic freedom and opportunity. AFP has more than 700,000 members, including members in all 50 states, and 25 state chapters. Patients First is not affiliated in any way with Patient First health clinics. For more information on Patients First, go to www.JoinPatientsFirst.com (http://rs6.net/tn.jsp?et=1102780163328&s=13633e=001ZT5NIGsO3Sm71FnQxFM7c909urFNCe1BrHFUUxAchDovoi3PcvaYNpHK1T8
3srDskHtH9Wp_AWd5JxMhq2QGU6eumkYedekDD05_3N4yT1ANSouKAwNgOyU__ZtAVjIv).

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HHS to Create a National Resource Center for Lesbian, Gay, Bisexual and Transgender Elders

HHS Secretary Kathleen Sebelius today (October 21) announced plans to establish the nation's first national resource center to assist communities across the country in their efforts to provide services and supports for older lesbian, gay, bisexual and transgender (LGBT) individuals.

Experts estimate that as many as 1.5 to 4 million LGBT individuals are age 60 and older. Agencies that provide services to older individuals may be unfamiliar or uncomfortable with the needs of this group of individuals. The new Resource Center for LGBT Elders will provide
information, assistance and resources for both LGBT organizations and mainstream aging services providers at the state and community level to assist them in the development and provision of culturally sensitive supports and services. The LGBT Center will also be available to educate the LGBT community about the importance of planning ahead for future long term care needs.

The LBGT Resource Center will help community-based organizations understand the unique needs and concerns of older LGBT individuals and assist them in implementing programs for local service providers, including providing help to LGBT caregivers who are providing care for
an older partner with health or other challenges.

The Administration on Aging will award a single Resource Center grant at approximately $250,000 per year, pending availability of funds. Eligible entities will include public-private nonprofit organizations with experience working on LGBT issues on a national level.

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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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FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

The safety and effectiveness of Fluarix for use in children ages 3 years and older is documented by a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who received Fluzone, a different influenza vaccine already licensed by the FDA for use in children ages 6 months and older. Study results showed that children 3 years and older vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza.

Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.

"This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”

With today’s approval, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children.

Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5 years. It is best to vaccinate children each fall, but vaccination also can occur in the winter months when influenza season often peaks.

Common adverse events experienced after administration of Fluarix are typical of those for flu shots and include pain, redness, and swelling at the injection site as well as irritability, loss of appetite, and drowsiness.

Because Fluarix contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products.

Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.

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FDA Approves New Treatment for Advanced Form of Kidney Cancer

The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.

Votrient is an oral medication that interferes with angiogenesis, the growth of new blood vessels needed for solid tumors to grow and survive.

Votrient is intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney. In 2009, approximately 49,000 people were diagnosed with renal cell carcinoma and 11,000 people died from the disease.

“The last five years have seen dramatic improvements in treatment options for patients with kidney cancer. Before 2005, the options available offered only limited effectiveness,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

The five other drugs approved for kidney cancer and their approval dates are: Sorafenib (December 2005), Sunitinib (January 2006), Temsirolimus (May 2007), Everolimus (March 2009), and Bevacizumab (July 2009).

The safety and effectiveness of Votrient was evaluated in a 435-patient study that examined a patient’s progression-free survival – the length of time, following enrollment in the study, before the tumor began growing again or before the patient died. Progression-free survival averaged 9.2 months for patients receiving Votrient compared to 4.2 months for patients who did not receive the drug.

Adverse reactions included diarrhea, high blood pressure, hair color changes, nausea, loss of appetite, vomiting, fatigue, weakness, abdominal pain and headache. Votrient can also cause severe and fatal liver toxicity. Health care professionals should order blood tests to monitor liver function before and during treatment with the drug. Since Votrient can harm a fetus, it should not be used during pregnancy.

The drug has also been associated with heart rhythm irregularities. Patients receiving Votrient should be monitored with periodic electrocardiograms, which measure heart rhythm, and blood tests to monitor electrolytes since an electrolyte imbalance can lead to an irregular heart rhythm.

Votrient is manufactured by London-based GlaxoSmithKline.

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Detailed Results from RV 144 HIV Vaccine Trial Published Today in The New England Journal of Medicine

Detailed Results from RV 144 HIV Vaccine Trial Published Today in The New England Journal of Medicine and Presented at the AIDS Vaccine 2009 Conference Provide Insight for Future Research

/PRNewswire/ -- Detailed results from the Prime-Boost HIV Vaccine Clinical Trial involving more than 16,000 adult volunteers in Thailand show that an investigational HIV vaccine regimen was safe and modestly effective at reducing the rate of HIV infection compared to placebo. These results were presented today by the trial collaborators to researchers gathered at the AIDS Vaccine 2009 Conference in Paris, France and published online by The New England Journal of Medicine.

"This is the first evidence that a prime-boost HIV vaccine regimen may prevent infection and represents a significant step forward for vaccine research," said Colonel Nelson Michael, Director, Division of Retrovirology, Walter Reed Army Institute of Research and Director, U.S. Military HIV Research Program (MHRP). "While it will not likely have any immediate public health benefit, we are hopeful that the findings will guide additional studies and accelerate research efforts toward a more effective vaccine."

According to the collaborating partners, the prime-boost combination of ALVAC HIV and AIDSVAX B/E appeared to lower the rate of HIV infection by 31.2 percent compared to placebo based on the modified intent-to-treat (mITT) population (n=51 vs. n=74, respectively; p=0.04). There was no effect on the amount of virus in the blood of the study volunteers who received either vaccine or placebo and subsequently became infected with HIV.

"Experts are interpreting the results and planning additional studies to maximize the knowledge gained from this study. Our first step is to see if we are able to determine correlates of protection," said Colonel Jerome Kim, Deputy Director (Science), MHRP and the HIV vaccines product manager for the U.S. Army. "Observations will inform future basic research, non-human primate and clinical studies to build on the RV144 result."

"All of this together emphasizes the opportunities these trial results afford - a new vantage point to examine what we understand about vaccine design, immunogenicity testing and animal models," added Colonel Kim. "Further research is required to determine if immunological mechanisms mediating protection against HIV may be different from those that control viral replication."

The trial results, first announced by trial collaborators on September 24, 2009, are based on the mITT population, which is the most clinically relevant analysis for this proof-of-concept study. Data from the mITT population, which was monitored by the independent Data and Safety Monitoring Board during its periodic review of the study, include all volunteers who entered the study less seven individuals who were already HIV infected on the first day of vaccination. "Given that you cannot protect someone from an infection that they already have acquired, the modified intent-to-treat analysis excluded these individuals," said Michael.

The detailed study data, which were embargoed for release before the AIDS Vaccine 2009 Conference and The New England Journal of Medicine publication, provide analyses of multiple data subgroups including ITT and per protocol (PP), their definitions and results. Data from the PP population show similar trends (26.2 percent reduction in HIV infection compared to placebo; n=36 vs. n= 50 respectively; p=0.16), though the results did not reach statistical significance due to the exclusion of nearly one-third of volunteers from the analysis and the associated loss of statistical power. For the ITT population, the vaccine regimen reduced infection rates by 26.4 percent compared to placebo (n=56 vs. n=76 respectively; p=0.08).

The U.S. Army would like to thank the more than 16,000 Thai men and women who consented to participate in this trial and the efforts of the Thai Ministry of Public Health. Trial collaborators include the U.S. Army, the Thai Ministry of Public Health, Mahidol University, the Armed Forces Research Institute of Medical Sciences - U.S. and Thai components, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, sanofi pasteur, Global Solutions for Infectious Diseases and the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

RV144 Trial Background

RV144 tested a prime-boost vaccine strategy that combined two vaccines based on strains (subtypes) of HIV that circulate in Thailand. The first, or "prime" vaccine, known as ALVAC HIV, was developed by sanofi pasteur and the booster vaccine, AIDSVAX B/E, was originally developed by VaxGen and is now licensed to Global Solutions for Infectious Diseases.

The proof-of-concept study, which began in 2003, was designed to evaluate the vaccine strategy's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood of those who became infected after they enrolled in the study.

More than 16,000 HIV-negative men and women between the ages of 18 to 30 years participated in the study; half of these participants received the prime-boost vaccine regimen and half received placebo. Volunteers received vaccinations over the course of six-months and were followed for an additional three-year period. Before agreeing to participate, all volunteers were informed of the potential risks associated with receiving the experimental vaccine regimen used and consented to participate in the study. Volunteers continued to receive an HIV test every six-months for three-years following vaccination, in addition to counseling on how to prevent becoming infected with HIV.

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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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FDA Approves New Vaccine for Prevention of Cervical Cancer

The FDA today approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by human papillomavirus (HPV) types 16 and 18. The vaccine is approved for use in girls and women ages 10 years through 25 years.

Genital HPV infections are the most common sexually-transmitted diseases in the United States, and HPV types 16 and 18 are the cause of about 70 percent of cervical cancers worldwide. There will be an estimated 11,270 new cases and 4,070 deaths from cervical cancer in the United States during 2009, according to the National Cancer Institute at the National Institutes of Health.

“The licensure of Cervarix adds another option in the prevention of cervical cancer” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “It has the potential to save lives from cervical cancer as well as reduce the need for biopsies and invasive procedures associated with the necessary follow-up from abnormal Pap tests.”

The primary clinical study for Cervarix included more than 18,000 women ages 15 years through 25 years in the United States and 11 other countries. Of these women, about 9,000 received Cervarix and 9,000 received Havrix, a licensed hepatitis A virus vaccine, as a control.

The results showed that among women who had not already been infected by HPV types 16 and/or 18 before the start of the study, Cervarix was about 93 percent effective in preventing precancerous cervical lesions caused by these HPV types. Among all Cervarix vaccinees, which included those who tested negative for HPV 16 and/or 18, and those who tested positive at the start of the study, Cervarix was approximately 53 percent effective in preventing precancerous cervical lesions.

Studies also were performed to measure the immune response to Cervarix in girls ages 10 years through 14 years. Their immune response was similar to that of women ages 15 years through 25 years, indicating that the vaccine should have similar effectiveness in the 10 through 14 year age group.

The current data show that Cervarix provides protection for about 6.4 years, but additional information on the length of protection is forthcoming.

No vaccine is 100 percent effective, and Cervarix does not protect against HPV infections that an individual may already have at the time of vaccination, nor does Cervarix necessarily protect against those HPV types not in the vaccine. Therefore, regular Pap tests continue to be recommended for all women who receive Cervarix. Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.

Cervarix contains the adjuvant ASO4. ASO4 is a combination of aluminum hydroxide and monophosphoryl lipid A (MPL) and is the first vaccine licensed by the FDA that includes MPL as an adjuvant. An adjuvant is a substance incorporated into a vaccine that enhances or directs the immune response of the vaccinated individual.

The safety of the vaccine was evaluated in about 24,000 girls and women, with about 13,000 of these receiving Cervarix. The most commonly reported adverse reactions in the Cervarix group included pain, redness, and swelling at the injection site, fatigue, headache, muscle and joint aches, and gastrointestinal distress.

Although Cervarix is not indicated for pregnant women, the FDA is requiring the manufacturer, GlaxoSmithKline Biologicals to conduct a postmarketing study to assess the safety of Cervarix in pregnant women following vaccination prior to identification of pregnancy. Women who are pregnant, or think that they may be pregnant, or plan to become pregnant during the vaccination course, should not use Cervarix.

Cervarix is administered in three separate shots, with the initial dose being followed by two additional shots at one and six months.

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AseraCare Home Health Now Serving Atlanta

(BUSINESS WIRE)--AseraCare Home Health of Atlanta announced that it is now offering comprehensive home health services to the residents of DeKalb, Fulton and Gwinnett counties in Georgia — including skilled nursing and specialized rehabilitation therapy.

AseraCare Home Health’s experienced staff provides outstanding clinical services to patients within the comfort of their own homes, enabling patients to maintain greater independence and achieve a higher quality of life.

The agency’s caregivers excel in treating patients who need in-home care as a result of joint replacement and other surgery, injury (including sports or job-related injuries), cardiac conditions and major illnesses.

“We provide an important service for Atlanta-area patients who need care once they leave the hospital and return to their own homes,” said Bob Donovan, President of AseraCare Home Health. “And, by working in conjunction with our sister Golden Living companies in the Atlanta area — including seven Golden LivingCenters and AseraCare Hospice — we are able to provide a full range of post-acute care services. Our integrated approach enables patients to move seamlessly from one care setting to another as their conditions require, with a singular focus on their needs.

“We look forward to a vibrant future here as we continue to strengthen our presence in the Atlanta market,” Donovan added.

The AseraCare Home Health office is located at 30 Perimeter Park, Suite 100, in Atlanta, Georgia. This complex is also home to the Atlanta offices of AseraCare Hospice and the administrative offices of Golden LivingCenters and Aegis Therapies.

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FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys

The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

Each year, about 2 out of every 1,000 men in the United States are newly diagnosed with genital warts.

Gardasil currently is approved for use in girls and women ages 9 through 26 for the prevention of cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11.

HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.

“This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Gardasil’s effectiveness was studied in a randomized trial of 4,055 males ages 16 through 26 years old. The results showed that in men who were not infected by HPV types 6 and 11 at the start of the study, Gardasil was nearly 90 percent effective in preventing genital warts caused by infection with HPV types 6 and 11.

Studies were conducted to measure the immune response to the vaccine in boys ages 9 through 15. The results showed that the immune response was as good as that found in the 16 through 26 years age group, indicating that the vaccine should have similar effectiveness.

The manufacturer will conduct postmarketing studies to obtain additional information on the safety and effectiveness of Gardasil in boys and men.

Gardasil is given as three injections over a 6-month period. Headache, fever and pain at the injection site, itching, redness, swelling and bruising, were the most common side effects observed.

Gardasil is manufactured by Merck and Company Inc. of Whitehouse Station, N.J.

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FDA Announces Plans for LASIK Quality of Life Project

The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.

The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

“This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure,” said Dr. Jeffrey Shuren, acting director of the FDA’s Center for Devices and Radiological Health.

The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.

The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.

“Many people in the U.S. undergo LASIK procedures,” said Shuren. “Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law. Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements.”

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FDA Approves Berinert to Treat Abdominal Attacks, Facial Swelling Associated With Hereditary Angioedema

The U.S. Food and Drug Administration today approved Berinert, the first treatment for acute abdominal attacks and facial swelling associated with a rare and potentially life-threatening genetic disease called hereditary angioedema (HAE).

Berinert is approved for adults and adolescents with HAE, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with HAE. The symptoms during abdominal attacks include severe abdominal pain, nausea, vomiting, cramps, and diarrhea.

“Berinert will enhance the treatment options for individuals who experience acute abdominal attacks and facial swelling associated with hereditary angioedema,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research.

Berinert is a protein product derived from human plasma. It regulates clotting and inflammatory reactions that, when impaired, can lead to local tissue swelling. In a clinical trial of 124 adults and adolescents with C1 esterase, inhibitor deficiency, Berinert was shown to be effective at treating the symptoms of acute moderate to severe abdominal attacks and facial swelling in patients with HAE.

Berinert is contraindicated in patients with a history of life-threatening hypersensitivity reaction to C1 esterase inhibitor preparations. The most serious adverse reaction reported in clinical studies was an increase in the severity of pain associated with HAE. The most common adverse reactions include subsequent HAE attack, headache, abdominal pain, nausea, muscle spasms, pain, diarrhea and vomiting.

Berinert is manufactured by CSL Behring, Inc., Marburg, Germany.

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H1N1 Vaccine Priority Groups Expanded

District 4 Public Health has received the first shipment of H1N1 vaccine at county health departments. Georgia's initial shipment of 54,800 doses of H1N1 vaccine was earmarked for young children. However, vaccine administration is now open on a first come, first serve basis to:

· Children and young adults ages 2-24 years
· Healthcare providers
· Emergency Responders
· Contacts or caregivers of infants less than 6 months of age

2009 H1N1 vaccine is CURRENTLY available at all health departments in District 4 in the form of nasal-spray flu vaccine, also known as LAIV for live attenuated influenza vaccine. No appointment is needed and vaccine will be given on a first come, first serve basis. H1N1 vaccine is being provided free of charge by Public Health, although administration fees may be charged to insurance, Medicaid or Medicare.

Additional nasal spray vaccine and a shipment of H1N1 injectible vaccine is expected soon but no delivery date has been given at this time.2009 H1N1 nasal spray is approved for people from 2 through 49 years of age with the following exceptions:

· pregnant women,
· anyone with a weakened immune system,
· anyone with a long-term health problem such as - heart disease - kidney or liver disease - lung disease - metabolic disease such as diabetes - asthma - anemia and other blood disorders
· children younger than 5 years with asthma or one or moreepisodes of wheezing during the past year,· anyone with certain muscle or nerve disorders (such as cerebral palsy) that can lead to breathing or swallowing problems,· anyone in close contact with a person with a severely weakened immune system (requiring care in a protected environment, such as a bone marrow transplant unit),
· children or adolescents on long-term aspirin treatment.

“Our first shipment of H1N1 shots will be given to pregnant women and people in the current priority group who cannot receive nasal spray flu vaccine,” said Dr. Michael Brackett District 4 medical director.

District 4 Public Health has activated a regional public health hotline (888.899.9788) that provides callers with H1N1 vaccine availability information. People can also get information on H1N1 vaccine availability at www.district4health.org. Health departments will be closed on Monday, October 12, 2009 in observance of the Columbus Day holiday but will reopen Tuesday at 8:00 a.m. For more information on seasonal and H1N1 flu visit www.flu.gov.
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HHS Unveils New Features on Flu.gov

HHS Secretary Kathleen Sebelius today unveiled several new resources on the federal government's one-stop resource for flu information -- www.flu.gov. The Web site now features a new H1N1 Flu Self-Evaluation guide for adults 18 and older along with a new Flu Myths and Facts section, which provides the public with the latest and most accurate information about the flu.

"Flu.gov is a one-stop clearinghouse for the latest news about the flu," said Secretary Sebelius. "These new resources on flu.gov will help individuals get critical information on how to protect themselves and their families from the H1N1 virus. They will also help us to get accurate information out into the public realm so people know what the facts are about the flu."

The new Flu Myths and Facts section on www.flu.gov debunks some of the myths about the H1N1 virus and vaccine, and provides accurate information on vaccinations, the flu, and public health.

The H1N1 Flu Self-Evaluation guide (http://www.flu.gov/evaluation/) on flu.gov will give individuals 18 and older more information about what they can do to take care of themselves, prevent the spread of the flu to other members of their families, and identify the warning signs of more serious flu symptoms -- symptoms that require the attention of a medical professional.

The information in the H1N1 Flu Self-Evaluation guide is designed for educational purposes only and is not a substitute for your doctor's advice. It does not capture identifiable information in any manner and is completely anonymous. Organizations providing public health education, blogs, and members of the media can add it to their Web sites.

"One way that we can help relieve some of the burden on the states and local providers this flu season is by helping people understand what the warning signs are when it comes to the flu," said Secretary Sebelius. "In addition to the Self-Evaluation guide, we have also created some
handy one-page information sheets called Flu Essentials that people can share with family, friends and neighbors."

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FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR

The U.S. Department of Health and Human Services (HHS) today marked today marked the recent approval of the 100th antiretroviral drug in association with the President's Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people
infected with and affected by HIV/AIDS worldwide.

The PEPFAR program is a cooperative effort that involves the Food and Drug Administration (FDA) and other HHS agencies, the State Department's Office of the U.S. Global AIDS Coordinator, U.S. Department of Defense, other federal agencies, host country governments, and many other international partners.

"This milestone exemplifies the dedication, caring, and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS," said HHS Secretary Kathleen Sebelius.

To date, more than 100 products have been assessed by the FDA and either fully or tentatively approved in association with the PEPFAR program. Of these, 29 have been new products and 71 have been generic copies of previously authorized antiretroviral products in the United States.
Twenty-two of these new products are new combinations or regimens that have not previously been authorized in the United States. In addition, there are seven new pediatric products considered innovative for patients in developing economies.

"As we recognize the 100th product authorized in this program, it is estimated that FDA's actions are allowing PEPFAR to spend $150 million more each year on patient access to care," FDA Commissioner Margaret A. Hamburg, M.D., told those attending an event marking the approval at the Pan American Health Organization (PAHO) headquarters in Washington, D.C.
"I look forward to developing and expanding FDA's international collaborations."

As of Sept. 30, 2008, the most recent figure available, PEPFAR supported life-saving antiretroviral treatment for more than 2.1 million men, women, and children living with HIV/AIDS. In fiscal year 2008, PEPFAR provided nearly $1.6 billion in support of treatment programs, including antiretroviral drugs and services.

"PEPFAR is committed to supporting partner countries to build and maintain sustainable procurement and supply chain systems," said U.S. Global AIDS Coordinator Eric Goosby.

Drug products used in PEPFAR receive a "tentative approval" and cannot be approved for marketing in the United States because of existing patents and marketing exclusivity. However, these products meet all the FDA's manufacturing quality, clinical safety, and efficacy requirements to produce them using the same standards as required for marketing in this country.

FDA performs all of its reviews of applications received in association with the PEPFAR on an expedited basis. After receiving approval or tentative approval from FDA under this expedited process, a generic anti-retroviral passes quickly on to the pre-qualification list maintained by the Secretariat of the World Health Organization (WHO), because of a confidentiality agreement that allows FDA to share data from its evaluations with the WHO team in Geneva.

"Improving access to good quality medicinal products is a core objective of public health efforts and one with a direct and measurable impact on health," said Margaret Chan, M.D., director-general of WHO. The goal of PEPFAR is to work with host nations to support treatment of at least 3 million people, prevention of 12 million new infections, and providing care for more than 12 million HIV-infected and affected people by 2013. In addition, PEPFAR will support training of at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.

"We need to urgently and actively implement strategies to promote greater affordability of both first and second line HIV/AIDS antiretrovirals," said Mirta Roses, M.D., director of PAHO, an
international public health agency that works to improve health and living standards in the Americas. "PEPFAR has made a tremendous difference in the health of disadvantaged people."

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Fewer U.S. Schools Selling Less Nutritious Food and Beverages

/PRNewswire/ -- Fewer secondary schools in the United States are selling less nutritious foods and beverages, such as candy and soda, according to a survey from the Centers for Disease Control and Prevention.

The greatest improvements were seen in states that have adopted strong school nutrition standards and policies for foods and beverages sold outside school meal programs.

The report, "Availability of Less Nutritious Snack Foods and Beverages in Secondary Schools - Selected States, 2002-2008," was published today in CDC's Morbidity and Mortality Weekly Report.

The report shows that among the 34 states that collected data in 2006 and 2008, the median percentage of secondary schools that did not sell soda or fruit drinks that are not 100 percent juice increased from 38 percent to 63 percent. The median percentage of secondary schools in these states that did not sell candy or salty snacks not low in fat increased from 46 percent in 2006 to 64 percent in 2008.

"The school environment is a key setting for influencing children's food choices and eating habits," said Howell Wechsler, Ed.D, M.P.H., director of CDC's Division of Adolescent and School Health. "By ensuring that only healthy food options are available, schools can model healthy eating behaviors, help improve students' diets, and help young people establish lifelong healthy eating habits."

Mississippi and Tennessee made the greatest progress in improving the nutrition environment in their schools. In Mississippi, the percentage of secondary schools that did not sell soda or fruit drinks that are not 100 percent juice increased from 22 percent in 2006 to 75 percent in 2008, while in Tennessee the percentage increased from 27 percent to 74 percent. These two states are national leaders in implementing strong statewide school nutrition standards.

"Efforts to improve the school nutrition environment are working, and Mississippi and Tennessee are excellent examples of this progress. However, there are still far too many schools selling less nutritious foods and beverages," said Wechsler.

The School Health Profiles Survey is conducted among a representative sample of secondary schools in a state, large urban school district, or territory. The data are collected from self-administered questionnaires from the principal and the lead health education teacher at each sampled school. The 2008 report includes data from 47 states, 20 cities, and four territories.

The 2008 study results varied dramatically across states.
-- In Hawaii, Connecticut, California, and Maine, more than two-thirds of
secondary schools did not sell baked goods, salty snacks not low in
fat, candy, soda or fruit drinks that were not 100 percent juice.

-- In Utah, Kansas, Idaho, and Nebraska, less than one-third of secondary
schools did not sell these items.

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New Rules Protect Patients' Genetic Information

Individuals' genetic information will have greater protections through new regulations issued today by the U.S. Departments of Health and Human Services (HHS), Labor, and the Treasury.

The interim final rule will help ensure that genetic information is not used adversely in determining health care coverage and will encourage more individuals to participate in genetic testing, which can help better identify and prevent certain illnesses.

"Echoing the late Senator Ted Kennedy, our efforts to protect Americans undergoing genetic testing from having the results of that testing used against them by their insurance companies is one of the 'first major new civil rights' of the new century," said HHS Secretary Kathleen Sebelius. "Consumer confidence in genetic testing can now grow and help researchers get a better handle on the genetic basis of diseases. Genetic testing will encourage the early diagnosis and treatment of certain diseases while allowing scientists to develop new medicines, treatments, and therapies."

The interim final rule with request for comments and the notice of proposed rulemaking implement Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA). Under GINA, and the interim final rule, group health plans and issuers in the group market cannot:
increase premiums for the group based on the results of one enrollee's genetic information; deny enrollment; impose pre-existing condition exclusions; or do other forms of underwriting based on genetic information. In the individual health insurance market, GINA prohibits issuers from using genetic information to deny coverage, raise premiums, or impose pre-existing condition exclusions.

Further, under GINA and the new interim final regulations, group health plans and health insurance issuers in both the group and individual markets cannot request, require or buy genetic information for underwriting purposes or prior to and in connection with enrollment.
Finally, plans and issuers are generally prohibited from asking individuals or family members to undergo a genetic test.

"Today's genetic technologies yield data that are vital to helping Americans make personal, medical decisions. It is essential that we protect such information and ensure it is not misused by health plans or insurers," said Labor Secretary Hilda L. Solis. "The rules issued today protect individuals against the unwarranted use of information related to their personal health because no one should have to fear that disclosure of their medical data will put their job or health coverage at risk."

Additionally, HHS, through its Office for Civil Rights (OCR), issued a notice of proposed rulemaking with a 60-day comment period, to propose changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to prohibit health plans from using or disclosing genetic information for underwriting purposes.

The proposed rule published today modifies the HIPAA Privacy Rule pursuant to GINA Title I to clarify that genetic information is health information and to prohibit the use and disclosure of genetic information by covered health plans for eligibility determinations, premium computations, applications of any pre-existing condition exclusions, and any other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits. In combination with the new penalties for violations of the HIPAA Privacy Rule, as provided for by the American Recovery and Reinvestment Act of 2009, a use or disclosure of genetic information in violation of the HIPAA Privacy Rule could result in a fine of $100 to $50,000 or more for each violation.

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FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.

Mirena was approved as a contraceptive by the FDA in 2000. It is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The device should be inserted by a trained health care professional.

"Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening," said Kathleen Uhl, M.D., director of the FDA's Office of Women's Health. "Bleeding can be so heavy that women must miss work, school, or social activities."

"In the primary clinical trial, women using Mirena showed a statistically significant reduction in menstrual blood loss," said Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research.

Participants in the clinical trial had excessive menstrual blood loss prior to treatment and did not have any medical conditions that are known to cause heavy menstrual bleeding, except for small uterine fibroids in some cases.

Mirena is recommended for women who have had a child. Clinical studies to support both the contraception and heavy menstrual bleeding indications have excluded women who have never been pregnant.

Since its approval in 2000, the most serious adverse reactions reported in patients using Mirena for any indication include: ectopic pregnancy (a pregnancy in which the fertilized egg grows outside the uterus); intrauterine pregnancy (a pregnancy with Mirena in place); group A streptococcal sepsis; an infection called pelvic inflammatory disease; embedment of the device in the uterine wall; and perforation of the uterine wall or cervix.

The most common adverse events reported by patients in the primary clinical trial using Mirena to treat heavy menstrual bleeding included uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation (dysmenorrhea), pelvic pain, and breast tenderness.

Mirena is made by Bayer HealthCare Pharmaceuticals, Inc., Wayne, N.J.

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