Emory Conducting Landmark Study to Treat ALS

Emory University researchers are participating in a groundbreaking clinical trial to treat patients with Amyotrophic Lateral Sclerosis (ALS) using human neural stem cells.

The Phase 1 trial, approved in 2009 by the U.S. Food and Drug Administration, is studying the safety of stem cells, and the surgical procedures and devices required, for multiple injections of the cells directly into the spinal cord.

“This is the first U.S. clinical trial of stem cell injections into the spinal cord for the treatment of ALS," says Jonathan Glass, MD, professor of neurology, Emory School of Medicine, and director of the Emory ALS Center and principal investigator (PI) of the clinical trial site.

“Our main goal in this early phase is to determine whether it is safe to inject stem cells into the spinal cord and whether the cells themselves are safe," says Glass.

Since the trial began in January, three patients with ALS have received injections. Up to 12 individuals will be enrolled in the first phase of the trial.

Nicholas Boulis, MD, assistant professor of neurosurgery at Emory School of Medicine, and a pioneer in developing surgical methods for delivery of therapeutics to the spinal cord, is performing the surgical procedures. Eva Feldman, MD, PhD, director of research at the University of Michigan Health System ALS Clinic, is the overall PI of the ALS clinical trials program.

“I am confident this study is taking therapies for the spinal cord to a new level,” says Boulis. “Depending on the success of this initial trial, there will be a follow-up phase II trial or a modified phase I trial that utilizes the techniques of surgical implementation.”

Also known as Lou Gehrig’s disease, ALS is a fatal neurodegenerative disease with no known cure. It causes the deterioration of specific nerve cells in the brain and spinal cord called motor neurons, which control muscle movement. As the illness progresses, patients lose their ability to walk, talk and breathe. According to the ALS Association, approximately 30,000 Americans have ALS at any given time and patients with the disease usually die within two to five years of diagnosis.

The stem cells used in the study, developed by the Maryland-based biotech company, Neuralstem, Inc., were prepared from cultured neural stem cells and may have the ability to mature into various types of cells in the nervous system. This includes motor neurons, the ones that are specifically lost in ALS.

Scientists say these stem cells will not generate new motor neurons, but may help protect the still-functioning motor neurons and slow the progression of the disease.

“We will closely follow these patients and will be eager to see results,” says Glass. “We are hopeful this is the first step toward a new way of treating the people who face this devastating disease.”

Watch on an interview with Glass at http://www.youtube.com/watch?v=5tln2i19wUs.

The Robert W. Woodruff Health Sciences Center of Emory University is an academic health science and service center focused on missions of teaching, research, health care and public service. Its components include the Emory University School of Medicine, Nell Hodgson Woodruff School of Nursing, and Rollins School of Public Health; Yerkes National Primate Research Center; Winship Cancer Institute of Emory University; and Emory Healthcare, the largest, most comprehensive health system in Georgia. Emory Healthcare includes: The Emory Clinic, Emory-Children's Center, Emory University Hospital, Emory University Hospital Midtown, Wesley Woods Center, and Emory University Orthopaedics & Spine Hospital. The Woodruff Health Sciences Center has $2.3 billion in operating expenses, 18,000 employees, 2,500 full-time and 1,500 affiliated faculty, 4,500 students and trainees, and a $5.7 billion economic impact on metro Atlanta. Learn more about Emory’s health sciences: http://emoryhealthblog.com - @emoryhealthsci (Twitter) - http://emoryhealthsciences.org

FDA Approves a Cellular Immunotherapy for Men With Advanced Prostate Cancer

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.


Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

"The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient's own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient's immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient's own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Provenge is manufactured by Seattle-based Dendreon Corp.

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FDA Approves New Device for Adults with Severe and Persistent Asthma

The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications.

The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy.

Inflammation causes the airways of people who have asthma to swell and narrow, making breathing difficult. The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient’s ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.

“The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system.

The FDA is requiring a five-year post-approval study of the device to study its long-term safety and effectiveness. The device manufacturer, Asthmatx, will follow many of the patients who were enrolled in the clinical trial and enroll 300 new patients at several medical centers across the United States.

Possible side effects during the course of treatment may include asthma attacks, wheezing, chest tightness or pain, partially collapsed lung (atelectasis), coughing up blood (hemoptysis), anxiety, headaches, and nausea. The Alair system is designed to reduce the number of severe asthma attacks on a long-term basis. However, there is a risk of immediate asthma attacks during the course of the treatment.

The Alair system is not for use in asthma patients with a pacemaker, internal defibrillator, or other implantable electronic device. Also, those patients with known sensitivities to lidocaine, atropine, or benzodiazepines should not use the device. Alair has not been studied for success in retreatment of the same area of the lung. Currently, patients should not be retreated with the Alair system in the same area of the lung.

Asthma patients considering the Alair system should not be treated while the following conditions are present: an active respiratory infection, coagulopathy (bleeding disorder), asthma exacerbations, or if they have had changes to their corticosteroid regimen 14 days before the proposed treatment.

Asthmatx Inc. is based in Sunnyvale, Calif.

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Pharmaceutical Giant AstraZenaca to Pay $520 Millionj for Off-Label Drug Marketing

AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and
effective by the Food and Drug Administration (FDA), the Departments of Justice and Health and Human Services' Health Care Fraud Enforcement Action Team (HEAT) announced today. Such unapproved uses are also known as "off-label" uses because they are not included in the drug's FDA
approved product label.

The Wilmington, Del.-based company signed a civil settlement to resolve allegations that by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.

Under the terms of the settlement, the federal government will receive $301,907,007 from the civil settlement, and the state Medicaid programs and the District of Columbia will share up to $218,092,993 of the civil settlement, depending on the number of states that participate in the
settlement. The allegations were originally brought in a lawsuit under the qui tam or whistleblower provisions of the False Claims Act and various state False Claims Act statutes.

Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug may not be marketed or promoted for off-label uses.

The FDA originally approved Seroquel in September 1997 for the treatment of manifestations of psychotic disorders. In September 2000, FDA proposed narrowing the approval for Seroquel to the short term treatment of schizophrenia only. In January 2004, the FDA approved Seroquel for short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania). In October 2006, the FDA approved Seroquel for bipolar depression.

The United States alleges that AstraZeneca illegally marketed Seroquel for uses never approved by the FDA. Specifically, between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness). These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.

According to the settlement agreement, AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.

In March 2006, AstraZeneca brought certain conduct to the attention of the government and then cooperated in the investigation of the allegations being settled today.

The United States contends that AstraZeneca promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs. The company also engaged doctors to give promotional speaker programs on unapproved
uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.

"Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars
directly out of taxpayers' pockets," said Attorney General Eric Holder. "This Administration is committed to recovering taxpayer money lost to health care fraud, whether it's by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation's biggest companies."

The United States also contends that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by
AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to "advise" AstraZeneca about marketing
messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel. The United States contends that these payments were intended to induce the doctors to prescribe Seroquel for
unapproved uses in violation of the federal Anti-Kickback Statute.

"Rooting out health care fraud is a top priority for the Obama Administration, said Kathleen Sebelius, Secretary of the Department of Health and Human Services. "Today's settlement sends a clear warning to any individual or company seeking to defraud our health care system and returns hundreds of millions of dollars of taxpayer money to the Medicare trust fund where they belong. It reflects the unprecedented energy, resources, and new ideas that this administration has devoted to
identifying, prosecuting, and ultimately preventing health care fraud. With the new anti-healthcare fraud resources in the Affordable Care Act, there has never been a worse time to try to steal from our health care system."

"Consumers are entitled to rely on the claims pharmaceutical companies make about the drugs they sell," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "Working with our federal and state partners, we will protect the integrity of our public health programs by ensuring that kickbacks from drug companies do not taint the medical decisions of health care professionals."

"When pharmaceutical companies interfere with the FDA's mission to insure that drugs are safe and effective, they undermine the doctor-patient relationship and put the health and safety of patients at
risk," said Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania. "People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors' judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues."

In addition to the civil settlement agreement, resolution of the matter includes a Corporate Integrity Agreement (CIA) between AstraZeneca and the Office of Inspector General of the Department of Health and Human Services. The five-year CIA requires, among other things, that a board
of directors committee annually review the company's compliance program and certify its effectiveness; that certain managers annually certify that their departments or functional areas are compliant; that AstraZeneca send doctors a letter notifying them about the settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging. AstraZeneca is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.

"As a result of this Corporate Integrity Agreement, the actions of AstraZeneca will be more transparent, its Board of Directors held more accountable, and the names of physicians receiving payments will be disclosed -- all leading to better protection for patients," said Department of Health and Human Services Inspector General Daniel R. Levinson.

The government's investigation was triggered by a whistleblower lawsuit filed under the FCA's qui tam provisions in the Eastern District of Pennsylvania. As part of today's resolution, James Wetta, the
whistleblower in that action, will receive more than $45 million from the federal share of the civil recovery.

This settlement is part of the government's emphasis on combating health care fraud and another step for the HEAT initiative, which was announced by Attorney General Holder and Secretary Sebelius in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid fraud through enhanced cooperation. One of the most powerful tools in that effort is the FCA, which the Justice Department has used to recover almost $2.8 billion since January
2009 in cases involving fraud against federal health care programs. The Justice Department's total recoveries in FCA cases since January 2009 are over $3.75 billion.

The civil settlement was reached by the U.S. Attorney's Office for the Eastern District of Pennsylvania and the Commercial Litigation Branch of the Justice Department's Civil Division. This investigation was conducted by the Department of Health and Human Services Office of Inspector General, U.S. Postal Service's Office of Inspector General and the FDA's Office of Criminal Investigations. Assistance was provided by representatives of FDA's Office of Chief Counsel and the National
Association of Medicaid Fraud Control Units.

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Fuqua Center for Late-Life Depression Celebrates 10 Years of Community Outreach

The late J.B. Fuqua, businessman and philanthropist who struggled with depression throughout his life, recognized a need in Georgia for a program to identify, educate and treat elderly patients suffering from depression.

His concern led to a 1999 gift to found the Fuqua Center for Late-Life Depression at Emory University's Wesley Woods Center. William M. McDonald, MD, geriatric psychiatrist and professor, Emory’s Department of Psychiatry and Behavioral Sciences, was appointed founding director. In 2003, an endowment from the Fuqua Foundation named McDonald the J.B. Fuqua Chair in Late-Life Depression in the Emory School of Medicine.

“Among other risk factors for depression and suicide among the elderly is the presence of a physical illness and social isolation,” says McDonald. "The Fuqua Center's ultimate goal is to provide community-based programs that will identify as many at-risk elderly individuals in the Atlanta region and throughout Georgia as possible, get them treatment and keep them well.”

Eve H. Byrd, MSN, MPH, executive director of the Fuqua Center, says, “The Fuqua Center’s success is largely due to its many valued community partnerships. Organizations such as the Georgia Division of Aging, the Atlanta Regional Commission, Aging Services of Georgia, Visiting Nurse Health System and the Department of Behavioral Health and Developmental Disabilities have worked with the Fuqua Center to improve the community’s understanding of older adult mental health, and improve their access to the medical care they need for depression and other mental illnesses.”

Since the Center was established in 1999, it has informed and engaged over 23,000 persons through community outreach and professional educational activities. The Fuqua Center also provides clinical services in 12 low-income residential facilities, made possible through a grant from the Jesse Parker Williams Foundation, and reaches rural older adults through telehealth services.

Thomas J. Lawley, MD, dean of the Emory University School of Medicine, says, “Through the generosity of the Fuqua family throughout the last decade and Dr. McDonald’s outstanding leadership, the Fuqua Center for Late-Life Depression has created a model program that has earned the dedication and respect of both state and private institutions. “The Fuqua Center and its numerous community partners have developed educational programs and clinical outreach services that have vastly extended the availability of mental health care to Georgia’s elderly.”

For more information regarding the Fuqua Center for Late-Life Depression at Emory University visit www.fuquacenter.org.

The Robert W. Woodruff Health Sciences Center of Emory University is an academic health science and service center focused on missions of teaching, research, health care and public service. Its components include the Emory University School of Medicine, Nell Hodgson Woodruff School of Nursing, and Rollins School of Public Health; Yerkes National Primate Research Center; Winship Cancer Institute of Emory University; and Emory Healthcare, the largest, most comprehensive health system in Georgia. Emory Healthcare includes: The Emory Clinic, Emory-Children's Center, Emory University Hospital, Emory University Hospital Midtown, Wesley Woods Center, and Emory University Orthopaedics & Spine Hospital. The Woodruff Health Sciences Center has $2.3 billion in operating expenses, 18,000 employees, 2,500 full-time and 1,500 affiliated faculty, 4,500 students and trainees, and a $5.7 billion economic impact on metro Atlanta. Learn more about Emory’s health sciences: http://emoryhealthblog.com - @emoryhealthsci (Twitter) - http://emoryhealthsciences.org
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FDA to Address Challenges of Using Complex Medical Devices in the Home

/PRNewswire/ -- The U.S. Food and Drug Administration today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home.

Hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices, and ventilators are among the medical products that have migrated to the home in recent years. And more hospital patients of all ages are being discharged to continue their medical treatment at home.

"Using complex medical devices at home carries unique challenges," said Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health. "Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product's functioning."

According to an FDA white paper, the initiative will develop guidance for manufacturers who intend to market a device for home use, provide for postmarket surveillance, and put in place other measures to encourage safe use of these products. In addition, the FDA is developing educational materials on home use of medical devices.

"The FDA's Home Use Initiative will help address the potential challenges, providing greater protection and awareness for patients who are being cared for in the home," Shuren said.

Currently, the FDA does not have a clear regulatory pathway for devices intended for home use that describes the unique factors that manufacturers should take into consideration when designing, testing, and labeling such products. The new home use guidance document that FDA intends to develop will:

-- make recommendations for actions manufacturers should take to support
premarket approval or clearance of these devices, including device
testing with at-home caregivers and patients in a non-clinical
setting,
-- define circumstances under which the FDA may exercise its authority to
require that certain devices cleared for marketing carry a statement
in the labeling that the device has not been cleared for use in the
home,
-- recommend postmarket surveillance to identify and address adverse
events that may occur in the home.


In addition to developing the guidance document, the FDA will launch a 10-month pilot program beginning in the summer of 2010 in which manufacturers of home use devices may voluntarily submit their labeling to the agency for posting on a central Web site repository. Posting medical device labeling in the repository will help home care patients and caregivers to quickly and conveniently access important information about the safe use of their devices.

The Home Use Initiative also contains measures for enhanced postmarket surveillance through HomeNet, a subnetwork of the FDA's Medical Device Surveillance Network, an adverse event reporting program that includes more than 350 health care facilities nationwide.

Understanding issues experienced by home users will help the FDA develop appropriate actions to address those issues in the future. It may also identify cases in which devices intended solely for use in a health care facility are being used at home. The FDA already has collected information on safety concerns related to home hemodialysis and is now collecting similar information on the use of some wound therapy devices.

The FDA is partnering with the Community Health Accreditation Program and the Joint Commission, which evaluates and accredits 17,000 U.S. health care organizations and programs, to strengthen home health agency accreditation criteria that relate to medical device safe use practices.

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Arthritis Impacts African-Americans and Hispanics More than Whites

/PRNewswire/ -- Arthritis causes more pain and limitations for African-Americans and Hispanics than for whites, according to a study released today by the Centers for Disease Control and Prevention.

African-Americans were 17 percent less likely to report having arthritis than whites, and Hispanics were 46 percent less likely to report the condition than whites, the study said. However, African-Americans and Hispanics with arthritis were almost twice as likely to report severe joint pain and work limitations attributed to their arthritis when compared to whites, it said.

The study, "Difference in the Prevalence and Impact of Arthritis among Racial / Ethnic Groups," was published in the journal Preventing Chronic Disease.

Arthritis is the leading cause of disability in the United States, affecting 1 in 5 adults. It interferes with work and other daily activities and can complicate the management of other chronic diseases. Arthritis encompasses more than 100 diseases and conditions that affect joints and other connective tissue.

The reason for the racial and ethnic differences, while unknown, may result from a lack of access to health care, language barriers and cultural differences, the report says.

"We must address these stark differences in arthritis impact by using what we know,'' said Jennifer Hootman, an epidemiologist for the CDC National Center for Chronic Disease Prevention and Health Promotion and co-author of the report. "We can educate those with arthritis about increasing physical activity and self-management and reducing obesity, especially those in groups bearing a disproportionate burden from arthritis."

The data, collected from the CDC National Health Interview Survey, are the first to estimate the national prevalence of arthritis and assess its impact among smaller racial and ethnic groups that are usually grouped together when reporting health statistics.

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Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available

/PRNewswire/ -- The U.S. Food and Drug Administration today announced, in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer, seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), which are propellants that move medication out of the inhaler and into the lungs of patients. Alternative medications that do not contain CFCs are available.

The affected products and their phase out schedule include:

Last Date to be
                         manufactured, sold or
  Inhaler Medication     dispensed in U.S.      Manufacturer
  Tilade Inhaler
   (nedocromil)         June 14, 2010           King Pharmaceuticals
  Alupent Inhalation
   Aerosol                                       Boehringer Ingelheim
   (metaproterenol)     June 14, 2010            Pharmaceuticals
  Azmacort Inhalation
   Aerosol
   (triamcinolone)      Dec. 31, 2010           Abbott Laboratories
  Intal Inhaler
   (cromolyn)           Dec. 31, 2010           King Pharmaceuticals
  Aerobid Inhaler
   System
   (flunisolide)        June 30, 2011           Forest Laboratories
  Combivent Inhalation
   Aerosol (albuterol
   and ipratropium in                            Boehringer Ingelheim
   combination)         Dec. 31, 2013            Pharmaceuticals
  Maxair Autohaler                               Graceway
   (pirbuterol)         Dec. 31, 2013            Pharmaceuticals

Patients using the inhalers scheduled to be phased out should talk to their health care professional about switching to one of several alternative treatments currently available. Until then, patients should continue using their current inhaler medication.

CFCs are harmful because they deplete the ozone layer miles above the Earth that absorb some of the sun's harmful ultraviolet rays. The United States has banned the general use of CFCs in consumer aerosols for decades, and eliminated the production of CFCs in the United States as of Jan. 1, 1996, except for certain limited uses, such as MDIs.

"During this transition, FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD," said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in FDA's Center for Drug Evaluation and Research. "We are currently working with professional societies and patient organizations to make sure patients understand which products will no longer be available and have information on which alternative medication might work best for them."

The CFC phase out is part of an international agreement to ban substances that deplete the Earth's ozone layer. The Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act aim to protect the public health and the environment from the potentially negative effects of ozone depletion. Bans on products containing CFCs began in the late 1970s.

The decision to phase out the products is the latest in a series of decisions related to the removal of CFC inhaler products from the market as required by the Clean Air Act. The agency proposed to phase-out the seven remaining products in 2007 and reached a final decision after reviewing more than 4,000 public comments and information submitted as part of a public meeting.

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FDA Approves Pancreatic Enzyme Product, Pancreaze

The U.S. Food and Drug Administration today approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). It is the third such product to receive FDA approval.

Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas.

Until today, Creon, manufactured by Abbott Products, Inc. (formerly Solvay Pharmaceuticals), and Zenpep, manufactured by Eurand Pharmaceuticals, were the only FDA-approved pancreatic enzyme products on the market.

Today’s approval of Pancreaze, manufactured by Johnson & Johnson, increases the supply of FDA-approved PEPs for the estimated 200,000 or more patients in the United States who need these products. Approved pancreatic enzyme products meet FDA standards for safety, efficacy, and product quality.

“The approval of Pancreaze, along with Creon and Zenpep, allows patients and healthcare professionals to choose the approved pancreatic enzyme product that is appropriate for them,” said Donna Griebel, M.D., director of the FDA’s Division of Gastroenterology Products.

Unapproved versions of pancreatic enzyme products have been available for many years. In October 2007, FDA established a date of April 28, 2010 for the makers of unapproved pancreatic enzyme products to stop manufacturing and distributing unapproved products. Supplies of approved PEPs are expected to meet demand.

Currently, the FDA is working with approved PEPs manufacturers, patient advocacy groups, and health care professional organizations to make the public aware of the availability of pancreatic enzyme products. Patients with questions about their current PEP or making a switch to a different pancreatic enzyme product should consult with their healthcare provider.

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New Study Evaluates Effectiveness of Vitamins for the Treatment of Sun-Damaged Skin

/PRNewswire/ -- While everyone knows that getting an adequate daily dose of vitamins and minerals is important in maintaining one's overall health, many question whether or not the vitamins touted in skin care products work in reducing the signs of sun-damaged skin. Now, a new study reviews the currently published scientific literature to determine what evidence exists to support the use of vitamins in skin care products to slow or reverse the effects of sun damage.

In the report entitled, "Vitamins and photoaging: Do scientific data support their use?", published online in the Journal of the American Academy of Dermatology, dermatologist Jenny Kim, M.D., Ph.D., FAAD, associate professor in the division of dermatology, department of medicine, at the University of California, Los Angeles (UCLA), David Geffen School of Medicine in Los Angeles, presented results of a study that may support the use of certain vitamins in oral or topical formulations.

"It is well documented that ultraviolet (UV) radiation contributes to premature skin aging through the process of photoaging, and there is increasing evidence that the antioxidant properties of vitamins may contribute to the prevention and treatment of photoaging," said Dr. Kim. "In fact, numerous companies developing cosmeceuticals base their effectiveness claims on the fact that their formulations contain vitamins proven in laboratories to modify cellular processes thought to contribute to the appearance of photoaged skin. As dermatologists, we can help our patients navigate this maze of marketing claims by sharing scientific data on the known efficacy of vitamins in skin care products."

Based on a comprehensive review of the available published data on the role of vitamins in skin care products, Dr. Kim and her colleagues, Jamie Zussman, M.D., FAAD, and Jennifer Ahdout, M.D., found there is evidence to support the potential role of vitamins A, C, E, and B3 in modifying the photoaging process.

"While it's evident that these vitamins can play a role in fighting sun damage, the question still remains whether these properties are effective when delivered in skin care products," notes Dr Kim.

Vitamin A: Effective in treating a variety of skin conditions

The two most common forms of vitamin A studied for their role in protecting the skin from UV-induced damage are retinols and carotenoids. Retinol is found in foods such as liver, milk and eggs, and is the most biologically active form of the vitamin. Carotenoids are found in many fruits and vegetables, and have strong antioxidant capabilities.

While carotenoids are not shown to be beneficial in the treatment of photoaging, research suggests that they may play a role in photoprotection by preventing UV-induced collagen breakdown.

"Although the evidence available at this time is not strong enough to offer definitive support for the use of dietary carotenoids for photoprotection, a role for carotenoids as a supplement to photoprotective agents should not be discounted yet," said Dr. Kim. "We hope to see larger-scale clinical trials conducted to further explore the photoprotective effects of carotenoids."

Unlike carotenoids, there is vast evidence supporting the role of topical retinoids (the class of substances formed by retinol and its natural and synthetic derivatives) in treating photoaged skin. For example, prescription retinoid formulations have the most scientific data to support their use in this area.

Dr. Kim noted that both tretinoin cream (0.025% and 0.05%) and tazarotene cream (0.1%) are already FDA-approved for the treatment of fine wrinkles, skin roughness and mottled hyperpigmentation caused by aging and sun exposure. In addition, she added that studies of other retinoids have shown that a once-daily application of 0.1% isotretinoin cream for 36 weeks was effective in reducing fine wrinkles.

Retinoids also are found in over-the-counter cosmeceuticals, but there is less clinical evidence supporting their effectiveness in improving photoaged skin. "An important point to remember with retinoids is that we cannot assume that all retinoids are equal in their ability to fight photoaging," said Dr. Kim. "In over-the-counter products, retinol appears to be the most effective retinoid based on clinical studies completed to date. However, patients should consult their dermatologist before using any topical retinoid, as side effects can occur when used with other topical products. When properly instructed by a dermatologist, most patients can tolerate topical retinoids and benefit from their effect."

Dr. Kim added that unlike topical retinoids, there is minimal evidence supporting the use of oral retinoids in the treatment of photoaging.

Vitamin C: Possible skin care product value

Vitamin C, a water-soluble vitamin also known as ascorbic acid that is found in citrus fruits and dark green leafy vegetables, plays an essential role in the production of collagen and elastin. Because of its antioxidant properties, vitamin C may reverse the negative effects of UV radiation in the skin, but there are few clinically controlled studies to confirm this theory.

"An animal study examining the role of vitamin C in reversing sun damage found that when 5% ascorbate was applied two hours before UVB and UVA exposure, UVB-induced skin wrinkling was reduced," said Dr. Kim. "Some of the human clinical trials have shown similar favorable results when applying a daily dose of L-ascorbic acid treatment, but all of these studies involved small sample sizes."

In addition, Dr. Kim pointed out that one concern of adding vitamin C to cosmeceuticals is that vitamin C is unstable when used in formulations, and it is not known how much, if any, intact molecule remains when applied to the skin.

"This problem has been partially overcome by chemically modifying ascorbic acid," said Dr. Kim. "However, for the body to use the supplied ascorbic acid, it must convert it to L-ascorbic acid, and many of the stabilized, commercially available forms have not been examined to determine whether this conversion is possible. For that reason, the average consumer will not be able to determine if a cosmeceutical containing vitamin C will be effective."

Vitamin E: A primary antioxidant

Vitamin E, or tocopherol, is a fat-soluble vitamin, and its synthetic form is found in many over-the-counter products. Working as an antioxidant, vitamin E protects cell membranes and is thought to play an important role in skin aging because of its antioxidant properties. While topical vitamin E is available in a variety of products, there is no data which support claims that it improves skin wrinkling, discoloration and texture.

"Topical vitamin E has been studied in humans, as in mice, more as a protectant to be used before sun exposure than as an agent to be included in cosmeceuticals to reduce the signs of skin aging," said Dr. Kim. "Through research we have learned that UV exposure significantly decreases levels of cutaneous vitamin E, and vitamin C should be included in any formulation containing vitamin E because of the important role it plays in maintaining active vitamin E levels."

Research also has explored combining vitamins E and C as an oral supplement to provide sun protection. Multiple studies suggest that this combination therapy is beneficial for photoprotection. However, Dr. Kim noted that overzealous oral vitamin E supplements may be harmful, and two new studies also suggest that a high intake of vitamin E may be associated with an increased risk of basal cell carcinoma.

Vitamin B3: A possible treatment for photoaging

The B vitamins consist of eight different water-soluble vitamins that are found in a variety of foods. Vitamin B3 has been shown to reduce blood cholesterol and atherosclerosis (a condition in which fatty materials collect along artery walls), but now new insights are examining its role as an effective treatment for several skin conditions - from acne to photoaging.

Specifically, Dr. Kim noted that vitamin B3 has been found to increase collagen production in in vitro studies and to reduce skin hyperpigmentation (dark spots) in clinical studies.

"There has been one clinical trial conducted in Caucasian women in which 50 women applied 5% niacinamide (topical vitamin B3) to one side of their faces twice per day for 12 weeks, and these women experienced significant reductions in the appearance of hyperpigmented spots, redness, wrinkles, and yellowing, as well as improved skin elasticity," said Dr. Kim. "While initial studies show promise that topical vitamin B3 may prevent UV-induced skin aging, larger clinical trials are needed to confirm its role as a definitive treatment of photoaging."

Bottom Line: Maintain healthy lifestyle, healthy diet, practice sun protection

Dr. Kim added that it is important for everyone to get an adequate daily supply of vitamins to maintain a healthy lifestyle, and any insufficiencies may negatively impact the skin's overall appearance.

"Research has shown a potential role for various vitamins in reducing the damaging effects of sun exposure on the skin. Whether topical or oral formulations containing these vitamins have a protective effect is uncertain. Given the number, type and variability of preparations available, consumers should understand from our study that skin care products with vitamins may not provide clinically meaningful improvement," said Dr. Kim. "What is known is that proper sun protection is key to the prevention of photoaging and should be top of mind at all times."

For more information on improving the appearance of your skin, go to the "AgingSkinNet" section of www.SkinCarePhysicians.com, a Web site developed by dermatologists that provides patients with up-to-date information on the treatment and management of disorders of the skin, hair and nails.

Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 16,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.

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HHS, HUD Partner to Allow Rental Assistance to Support Inedpendent Living for Non-Elderly Persons with Disabilities

Thousands of Americans with disabilities will have housing assistance specifically targeted to meet their needs, Health and Human Services (HHS) Secretary Kathleen Sebelius and Housing and Urban Development (HUD) Secretary Shaun Donovan announced today.

As part of President Obama's Year of Community Living initiative, HHS and HUD collaborated to provide housing support for non-elderly persons with disabilities to live productive independent lives in their communities rather than in institutional settings.

HUD is offering approximately $40 million to public housing authorities across the country to fund approximately 5,300 Housing Choice Vouchers for non-elderly persons with disabilities, allowing them to live independently. HHS will use its network of state Medicaid agencies and local human service organizations to link eligible individuals and their families to local housing agencies who will administer voucher distribution.

"This number of vouchers to this community is a major milestone for HUD," said Donovan. "I am pleased that two federal agencies have combined efforts to give these individuals the independence they so desperately want and deserve."

"This commitment by HHS and HUD to directly link housing support to these individuals will be of immeasurable value not only to them, but to the communities in which they will be living," said Sebelius. "Individuals with disabilities have so much to contribute to the quality of life in our communities when given the freedom and opportunity to do so."

Of the 5,300 vouchers set aside as part of this program, up to1,000 will be specifically targeted for non-elderly individuals with disabilities currently living in institutions but who could move into the community with assistance (Category II). The remaining 4,300 (Category I) can be used for this purpose also, but are targeted for use by non-elderly individuals with disabilities and their families in the community to allow them to access affordable housing that adequately meets their needs.

In addition, HUD is encouraging housing authorities to establish a selection preference to make some, or all, of their Category I allocation available to individuals with disabilities and their families who, without housing assistance, are at risk of institutionalization. Housing authorities have 90 days to submit their applications to HUD. HUD expects to have funding awards ready late fall 2010.

"Many of these individuals are low-income and can not afford market rates for housing. For a number of Americans, these vouchers, along with Medicaid home and community-based services, are essential supports that make the President's vision for community living possible," Sebelius noted.

The vouchers will augment work already being done by the Centers for Medicare and Medicaid Services (CMS) through its Medicaid Money Follows the Person (MFP) grant program. Originally set to expire next year, the "Patient Protection and Affordable Care Act of 2010" extended the MFP program through 2016 with an additional appropriation of over $2 billion. The Act also cut to three months, from the previous six months, the amount of time a person must be in an institution to qualify for help making the transition to community life.

Now in its third year, the MFP program has made it possible for almost 6,000 people to live more independent lives by providing necessary supports and services in the community. Some 29 states and the District of Columbia have MFP programs.

The Year of Community Living is an outgrowth of a 1999 Supreme Court decision in Olmstead v. L.C., in which the court ruled that under the Americans with Disabilities Act (ADA) unnecessarily institutionalizing a person with a disability who, with proper support, can live in the community can amount to discrimination. In its ruling, the Court said that institutionalization severely limits the person's ability to interact with family and friends, to work and to make a life for him or herself.

As a result of the Olmstead ruling, HHS issued guidance to states on how to make their Medicaid programs more responsive to people living with disabilities who wish to reside in the least restrictive setting. Today's announcement is yet another step in HHS's 10-year effort to achieve that goal.

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HHS Secretary Kathleen Sebelius and Other Health Experts to Host Webchat on Health Insurance Reform and Seniors

U.S. Department of Health and Human Services Secretary Kathleen Sebelius and Assistant Secretary for the Administration on Aging Kathy Greenlee will host a webchat today, THURSDAY April 8, to
discuss the benefits of the new health reform law as it relates to America's seniors. Sebelius and Greenlee will highlight some of the immediate benefits of health reform for America's seniors before
answering pre-submitted questions from the public.

The chat is the second in a series of discussions that is designed to help Americans understand the benefits of the newly passed health insurance reform law.

Members of the public are encouraged to submit questions via email to HealthReform@hhs.gov. HHS officials will try to answer as many questions as possible during the web chat and post up questions and answers on the web site as well.

WHAT: Health Reform Weekly Webchat with HHS Secretary Kathleen Sebelius, Assistant Secretary for Aging Kathy Greenlee and Principal Deputy Administrator for the Centers for Medicare & Medicaid Services, Marilyn Tavenner

WHEN: Thursday April 8, 2010 at 1:00 p.m. EDT

WHERE: www.HealthReform.gov

The webchat will be available via satellite feed at the following coordinates:

SATELLITE:
G-19 04K Digital Only Slot B
Orbital Location: 97' West

Ku-Band
D/L: 11786.4Mhz Horizontal
FEC: 3/4
Symbol Rate: 6.111319 @ 204 packet = 8.448 Data Rate
4X3 Aspect Ratio


For more information on the new health reform law please visit www.healthreform.gov

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HHS Announces $267 Million in Recovery Act Funds for New Health IT Regional Extension Centers

U.S. Department of Health and Human Services Secretary Kathleen Sebelius announced today that more than $267 million has been awarded to 28 additional non-profit organizations to establish Health Information Technology Regional Extension Centers (RECs). This investment, funded by the American Recovery and Reinvestment Act of 2009, will help grow the emerging health information technology (health IT) industry which is expected to support tens of thousands of jobs ranging from nurses and pharmacy techs to IT technicians and trainers.

RECs enable health care practitioners to reach out to a local resource for technical assistance, guidance, and information on best practices. RECs are designed to address unique community requirements and to support and accelerate provider efforts to become meaningful users of
electronic health records.

"Health care in our country is community-based. Today's awards represent our ongoing commitment to make sure that health providers have the necessary support within their communities to maximize the use of health IT to improve the care they provide to their patients," said Secretary Sebelius.

This round of awards, bringing the total number of REC's to 60, will provide nationwide outreach and technical support services to at least 100,000 primary care providers and hospitals within two years. The primary care provider is usually the first medical practitioner contacted by a patient. Studies have also found that primary care providers are at the forefront of practicing preventative medicine, a
key to improving population health and reducing overall health costs. More than $375 million had been awarded earlier to RECs under this program.

Additionally, all REC awardees, those announced today and the 32 announced on Feb. 12, 2010, now have an opportunity to apply for a two-year expansion supplemental award. The supplemental awards would ensure that health IT support services are available to over 2,000 of the nation's critical access hospitals and rural hospitals, both defined as having 50 beds or less. Approximately $25 million is available through this supplemental expansion program.

"Regional extension centers will provide the needed hands-on, field support for all health care providers to advance the rapid adoption and use of health IT. RECs are a vital part of our overall efforts to
improve the quality and efficiency of health care through the effective use of health IT," said Dr. David Blumenthal, national coordinator for health information technology.

Today's awards are part of the $2 billion effort by the American Recovery and Reinvestment Act of 2009 to achieve widespread meaningful use of health IT and provide use of an electronic health record by every person by the year 2014.

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FDA Approves New Formulation for OxyContin

The U.S. Food and Drug Administration today approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication.

OxyContin is made to slowly release the potent opioid oxycodone to treat patients who require a continuous, around-the-clock opioid analgesic for management of their moderate to severe pain for an extended period of time. Because of its controlled-release properties, each OxyContin tablet contains a large quantity of oxycodone, which allows patients to take their drug less often. However, people intent on abusing the previous formulation have been able to release high levels of oxycodone all at once, which can result in a fatal overdose and contributes to high rates of OxyContin abuse.

The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication. The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended.

“Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction,” said Bob Rappaport, M.D., director of the Division of Anesthesia and Analgesia Products in the FDA’s Center for Drug Evaluation and Research.

“As with all opioids, safety is an important consideration,” he said. “Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain.”

According to the U.S. Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health, approximately half a million people used OxyContin non-medically for the first time in 2008.

The manufacturer of OxyContin, Purdue Pharma L.P., will be required to conduct a postmarket study to collect data on the extent to which the new formulation reduces abuse and misuse of this opioid. The FDA is also requiring a REMS (Risk Evaluation and Mitigation Strategy) that will include the issuance of a Medication Guide to patients and a requirement for prescriber education regarding the appropriate use of opioid analgesics in the treatment of pain.

Purdue Pharma is based in Stamford, Conn.

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