Terminal patients would still need care, but in more expensive settings; other states reject similar proposals

The State of Florida’s proposed elimination of the Medicaid benefit that provides hospice care to some of the state’s most fragile individuals actually would cost Florida millions more than the state currently spends – adding to the state’s budget deficit rather than reducing it – according to a newly released study commissioned by Florida Hospices and Palliative Care (FHPC), the statewide group representing all of the state’s hospice providers.

FHPC engaged The Moran Company, a Washington-based health care research and consulting firm, to examine the state’s financial assumptions and develop an independent evaluation of the impact of eliminating the Medicaid Hospice Benefit, as recommended by Florida’s Agency for Health Care Administration (AHCA). The study reviewed actual state data for fiscal year 2007 and concluded that if the cut had been in place at that time, the state’s health care budget would have been $3.7 million more. In contrast to the findings of the Moran Company report, AHCA claims cutting the benefit for fiscal year 2009 would save the state $343 million in Medicaid payments.

FHPC Executive Director Paul Ledford said, “This report reinforces our view that Florida can’t afford to take this misguided approach to dealing with its budget difficulties, especially since it will only make the budget situation worse. Cutting the Medicaid Hospice Benefit doesn’t mean the needs of the terminal patient change; it just shifts those costs to more expensive ways of delivering those vital services.

“We appreciate the financial challenges that Florida’s government faces, but cutting the Medicaid Hospice Benefit simply isn’t the answer – or even a part of the answer,” Ledford added.

The report contained the following major findings:

  • Eliminating the Medicaid Hospice Benefit will not save the state money, and likely will result in increased spending for mandatory services. The report conservatively estimates an additional $3.7 million in state Medicaid costs, as patients needing end-of-life care would end up in more expensive settings, such as hospital emergency rooms.
  • Such action also will likely increase the burden on Florida counties to provide indigent care through already financially stressed indigent care programs.
  • The loss of the service coordination, care management, and supportive services offered by hospice will increase fragmentation of care for terminally ill patients, limit their access to palliative care, and burden families and caregivers, potentially limiting their employment and educational options.
  • The beneficiaries in Florida’s Medicaid hospice program are different from the Medicare population that dominates hospice services. Florida Medicaid-only hospice patients are younger and more likely to be in the terminal stages of cancer or have HIV/AIDS related conditions than Medicare or dual Medicare/Medicaid patients. Their average length of stay in hospice is shorter, and their care is more likely to be complex and involve management of severe symptoms that, unmanaged, trigger emergency room visits and/or hospitalization.
  • The cut also would mean that Florida will lose revenue. For every dollar Florida cuts in the hospice benefit, the state will lose $1.25 in matching Federal Medicaid support.

The research study also noted that, until now, every other state that has studied wiping out the Medicaid Hospice Benefit has rejected that approach for precisely the same reason – it ends up costing more money than would be “saved.” In fact, Connecticut recently added the benefit, and now only two states do not offer it.

“Hospice has a vital place in health care,” noted Anthony J. Palumbo, FHPC President and CEO of Hospice of Citrus County and Hospice of the Nature Coast. “In addition to the compassionate, hands-on medical care we provide, we also take care of our patients’ psychosocial and spiritual needs. We care for patients as well as their loved ones.”

“Hospice is an all-inclusive benefit,” Palumbo added. “Every visit by our nurses, hospice aides, social workers, chaplains, physicians and community-based volunteers is covered by a per diem payment that is widely recognized as cost-effective. And, from that same small per diem payment, hospices provide patients – without charge – all of the prescription drugs, over-the-counter medications, medical equipment and medical supplies associated with a patient’s primary diagnosis. Hospices also offer bereavement care to each patient’s loved ones for up to a year after the patient has died, all at no additional cost to the health care payment system.”

Source: Florida Hospices and Palliative Care


The Children’s Hospital of Philadelphia is named the nation’s best pediatric hospital by Parents magazine.

“Children’s Hospital employees work tirelessly everyday to ensure every family has the ideal patient experience and we are truly grateful to our dedicated and talented staff,” said Steven M. Altschuler, M.D., president and chief executive officer of The Children’s Hospital of Philadelphia. “We recognize our responsibility to provide excellent patient care, to conduct innovative research and to train tomorrow’s pediatric specialists; our ultimate goal is to eradicate pediatric disease worldwide.”

Parents surveyed more than 100 children’s hospitals, to determine where the more than three million children hospitalized each year can get the best care possible. The results of the survey will appear in the February 2009 issue of Parents magazine on newsstands nationwide January 13, 2009.

“Every parent wants to make the most informed decisions about their child’s health, and that’s especially important when a child is facing a serious illness,” says Dana Points, editor in chief of Parents. “We created this guide with the hope of making the difficult process of choosing the right hospital a little easier.”

The Parents 10 Best Children’s Hospital survey provides the most extensive data-driven comparison of children’s hospitals to date. All surveyed hospitals are members of the National Association of Children’s Hospitals and Related Institutions. Hospitals are ranked on their responses to detailed questions in the following areas: survival rates for childhood cancer, pediatric heart disease, and other critical conditions; their experience in performing certain complex procedures; the depth of the research program; safeguards to prevent medical errors; staffing ratios and quality; waiting times in the emergency department; community outreach; and services that address the emotional needs of sick children and their families.

Parents, published monthly by Meredith Corporation, (also former publishers of the now defunct Child magazine) has been America’s #1 family magazine for more than 80 years. Since its inception in 1926, it has been a trusted source by every generation of parents.

In addition to the overall ranking, Parents magazine also ranked Children’s Hospital’s emergency medicine, neonatology and pulmonology divisions number one in the nation and the Cardiac Center, Cancer Center and orthopaedics division ranked second.

Facts about the six ranked divisions:
Cardiac Center

The Cardiac Center at The Children’s Hospital of Philadelphia is one of the world’s largest and most experienced programs, with more than 24,000 outpatient visits and 1,500 admissions, more than 1,000 surgeries, 1,000 catheterizations and 53,000 diagnostic studies each year; patients are referred to the Center from across the nation and around the world. The program’s high volumes of complex cases, along with the dedicated team of 500 professionals, correlate directly with its consistently exceptional record of outcomes. The Cardiac Center provides comprehensive services across the full continuum of care, from diagnosing a fetus with congenital heart disease to caring for them through adulthood.

Thanks to advances in care, many pioneered at CHOP, the first generation of children with previously fatal congenital heart disease are surviving – and thriving – into adulthood. In 2005, the Cardiac Center created the Philadelphia Adult Congenital Heart Center, in partnership with the University of Pennsylvania Health System. Uniting the resources of a renowned pediatric heart program with a national leader in adult cardiac care, the Center offers comprehensive care to meet the unique needs of this rapidly growing population.

The Fetal Heart Program, one of only a few and the largest – of its kind in the U.S., attracting referrals from across the nation, has performed more than 2,000 fetal heart studies annually as it provides diagnoses, education and treatment plans. The newest addition to the Cardiac Center is the Garbose Family Special Delivery Unit (SDU), the first birth facility in the world exclusively for babies with birth defects. It includes eight labor-delivery rooms and two operating rooms for c-section deliveries and fetal surgery. Congenital heart disease is the most common birth defect; approximately half the babies born in the SDU will be Fetal Heart Program babies. The newborns are evaluated by cardiologists and, if necessary, transported to the Evelyn and Daniel M. Tabas Cardiac Intensive Care Unit just down the hall.

Emergency Medicine

The CHOP Emergency Department (ED) provides safe and efficient, family-centered, high quality care to more than 80,000 critically ill, injured, or sick children each year. The ED is a 75-bed, state of the art facility; each patient room is private, designed for families’ comfort and equipped with TVs and VCRs for education or entertainment. No patient is ever treated in a hallway and patients are never diverted. The ED has been designed to safeguard patients in the event of a bio-terrorism attack; it is equipped with three decontamination quarters to allow the team to care for whole families or critically ill children.

Emergency Medicine at the Children’s Hospital of Philadelphia is multi-faceted and includes not just the care provided by the Emergency Department, but the life-saving interventions of the Poison Control Center, Trauma Team and Medical Transport Team. The ED team’s commitment extends beyond delivery of care to injury prevention efforts and advocacy for all children.

Neonatology Division

The Harriet and Ronald Lassin Newborn/Infant Intensive Care Unit (N/IICU) at Children’s Hospital continues to make significant advances in the field of neonatal medicine and the care of the most fragile infants. To meet rapidly growing demand, the N/IICU facility is expanding to a 75-bed unit, equipped with the latest technology and advances in neonatal medicine to care for neonates with all types of diseases. The team’s clinical expertise has been recognized by regional providers as Children’s Hospital operates NICUs at seven community hospitals. The board-certified N/IICU faculty are leaders in the field, clinically and in research. Patient volume at the main campus has grown to more than 1,000 admissions; about 20 percent of neonatal admissions come from beyond the metropolitan Philadelphia region. Children’s Hospital is nationally recognized as a leader in the repair of congenital anomalies during the neonatal period.

The Neonatal Follow-Up Program monitors the physical and cognitive development of high-risk premature patients well into their childhood years, providing information, education and support for families. This program links with other clinics, provides referrals for early intervention and includes a program to promote early literacy.

Cancer Center

The mission of the Cancer Center at Children’s Hospital is to provide the most skilled, compassionate care available. State-of-the-art facilities enable us to focus on the needs of both children and their families. The Cancer Center offers comprehensive, family-centered care with more than 40 pediatric oncologists with expertise spanning every form of childhood cancer, enabling us to provide more breadth and depth than any other pediatric cancer program in the country. Each year, we treat more than 500 new patients and follow more than 4,000 patients previously treated for childhood cancer.

In addition, Children’s Hospital has launched a new Center for Childhood Cancer Research, bringing together the diverse talents of investigators from multiple disciplines with the goal of eradicating the problem of cancer in children. The Center pursues this goal through both basic and clinical research with the goal of incorporating research advancements into routine clinical care for children with cancer.

The Children’s Hospital of Philadelphia also supports cancer survivors. The Cancer Survivorship Program cares for and tracks long-term survivors of childhood cancer, and conducts research to understand how cancer treatment can affect a patient many years later, making recommendations about how to mitigate harmful side effects.

Orthopaedic Division

The Children’s Hospital of Philadelphia is internationally recognized for its pioneering work in pediatric orthopaedic patient care, education, and basic and clinical research; in fact, CHOP physicians have pioneered 16 orthopaedic surgical procedures and are internationally renowned for their skill in limb-sparing surgery, tumors, spines, hand, sports and trauma. The orthopaedic team provides a full-range of services from caring for children with common conditions such as sports injuries to those with the most complex musculoskeletal disorders such as cerebral palsy and bone tumors.

Each year, the team provides more than 62,000 outpatient visits in our orthopaedic and musculoskeletal programs, receives over 1,300 admissions and performs nearly 2,600 surgical cases. In addition to Main Campus, outpatient care is available at six Specialty Care Centers, and surgical procedures are offered at three Ambulatory Surgery Centers throughout the region. We have a broad referral network, with 16 percent of surgical cases coming from outside the Philadelphia region. The orthopaedics team has also expanded programs in neuromuscular, spine and cerebral palsy and established a world-class hand surgery program and are one of a handful of institutions that treat children with complex spine and chest wall deformities.

With orthopaedics at its core, Children’s Hospital’s unique Musculoskeletal Center, believed to be the only one of its kind in the nation, brings together a multidisciplinary team representing 10 pediatric subspecialties to provide seamless and comprehensive care for infants, children and young adults with congenital or acquired musculoskeletal conditions. This Center treats nearly 24,000 outpatients with the most complex musculoskeletal conditions such as limb deformities, spina bifida, and scoliosis.

Pulmonology Division

The Division of Pulmonology at The Children’s Hospital of Philadelphia is internationally known for being at the forefront of patient care and research into causes and treatments for the entire range of diseases affecting the lung, chest wall and control of respiration in children. These disorders include asthma, cystic fibrosis, sleep disorders, congenital lung disorders and chronic respiratory failure requiring home mechanical ventilation or other forms of technology. The Division has extensive expertise in managing complex end-stage lung diseases and in lung transplantation. The team believes in a holistic, multidisciplinary approach that utilizes the talents of many healthcare professionals, including physicians, nurse practitioners, social workers, nutritionists, respiratory therapists and physical therapists. These professionals work together to educate families and patients about their disorders, which in turn allows the team to partner with patients to achieve the best possible outcomes.

About The Children’s Hospital of Philadelphia: The Children’s Hospital of Philadelphia was founded in 1855 as the nation’s first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children’s Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking second in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 430-bed hospital recognition as a leading advocate for children and adolescents. For more information, visit http://www.chop.edu/.

Source: The Children’s Hospital of Philadelphia


NovaRx Corporation announced the opening of the company’s pivotal Phase 3 clinical trial of Lucanix(R) (belagenpumatucel-L) in the treatment of advanced non-small cell lung cancer (NSCLC) in Serbia. Serbian oncology centers participating in the trial include the Clinical Hospital Center Benzanijska Kosa in Belgrade, the Clinic for Pulmonary Diseases and TB “Knez Selo” in Nis, and the Institute for Pulmonary Disease of Vojvodina in Sremska Kamenica.

Serbia is the first European country to open the Lucanix(R) study for enrollment. The study is an international, multicenter, randomized, double-blind study involving up to 700 individuals with advanced stage NSCLC, and will be conducted at approximately 90 clinical sites in the U.S., Canada, Europe, and India. Treatment of patients in the Phase 3 Lucanix(R) trial at multiple clinical centers began in the United States in August 2008.

“For my team and Institution, the Lucanix(R) trial will be a challenge and also an affirmation of innovation in the development of lung cancer treatments,” stated Dr. Vladimir Kovcin, Head of Oncology at the Clinical Hospital Center Bezanijska Kosa in Belgrade, Serbia. “Given the expense of current therapies for NSCLC, many advanced-stage Serbian lung cancer patients do not have many treatment options for their disease. Lucanix(R) is unique from other therapies because it enhances the immune system in a natural way. It is a great pleasure to participate in this clinical trial.”

In a previous Phase 2 clinical trial, survival ranges among advanced-stage non-small cell lung cancer patients who received Lucanix(R) after receiving chemotherapy were more than double the survival ranges of individuals being treated with the current standard of care. Patients on Lucanix(R) demonstrated a one-year survival of 61% and a median survival of 16 months. Late-stage NSCLC patients typically demonstrate a less than 30% one-year survival. A second, investigator-initiated Phase 2 study supported these results.

Importantly, there were no significant toxicities related to Lucanix(R) in these trials. Side effects have been generally mild and similar to brief influenza symptoms.

“The safety and side effect profile of Lucanix(R) seems to be acceptable for patients’ quality of life, which is very important,” Kovcin stated. “If the Phase 3 clinical trial is successful, Lucanix(R) could change lung cancer treatment strategy in Serbia and the rest of the world.”

According to the WHO-Europe, lung cancer represents one of the leading causes of death for males and females in Serbia. In 2006, there were 5,400 new cases of lung cancer diagnosed in Serbia, and 4839 deaths from the disease. Lung cancer represents the number one cause of cancer death throughout the world.

“We are aggressively expanding the reach of our international Phase 3 trial of Lucanix(R) and we are pleased Serbia is the first of many countries in Europe where this experimental treatment will be available for patients.” said Dr Norrie Russell, President and Chief Operating Officer of NovaRx. “We are grateful to those centers and those patients who are helping establish whether, one day, Lucanix(R) will provide a much-needed option for lung cancer patients worldwide.”

About Lucanix(R):

In contrast to conventional cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill normal cells as well as tumor cells, Lucanix(R) induces the patient’s immune system to specifically target the cancer.

Lucanix(R) consists of four non-small cell lung cancer cell lines that have been gene-modified to block a molecule called transforming growth factor-beta (TGF-beta), which is commonly produced by cancer cells. The molecule allows cancer to hide from the body’s natural immune system. When TGF-beta is blocked, the immune system can see, find, and destroy the cancer naturally.

United States Food & Drug Administration granted NovaRx Fast-Track approval for the Phase 3 Lucanix(R) trial in March of 2007, and Special Protocol Assessment approval in January of 2008.

Lucanix(R) currently is under clinical investigation and has not been approved for use in the United States, Canada, Europe or elsewhere. The product has not been proved to be safe or effective, and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.

Source: NovaRx Corporation


According to the latest science, resveratrol pill users are best advised to consume modest doses of resveratrol plus an array of antioxidant molecules as typically provided in 3 to 5 glasses of aged, red wine, rather than resveratrol alone.

The most recent study shows mega-dose resveratrol alone fails to prolong the life of laboratory mice. In fact, mega-doses shortened the life of animals compared to a standard calorie diet with no resveratrol. [Cell Metabolism. 2008 Aug; 8:157-68]

“While resveratrol (rez-vair-ah-trol), an antioxidant molecule concentrated in red wine (about 1 milligram per glass), is touted for its health properties, partially explaining the French Paradox (why French wine drinkers have cardiac mortality rates 30% lower than North Americans despite their high-calorie, high-fat diets), it is not the sole molecule responsible for longevity,” says Bill Sardi, spokesperson for Longevinex(R), a leading brand of resveratrol dietary supplement.

“The total array of red wine molecules found in the best red wine, about 60 milligrams per 5-ounce glass, or 180-300 milligrams in 3 to 5 glasses, is the suggested healthy dosage range,” says Sardi.

Consistently, studies show modest doses of red wine lower mortality rates over abstention or over-consumption. [American Journal Epidemiology 1986 Sep; 124(3):481-9] Red wine pills offer the advantage of no alcohol, no calories or sulfite preservatives.

Cause of shortened lifespan

The negative effect upon lifespan with mega-dose resveratrol may emanate from over-inhibition of tumor necrosis factor (TNF), an inflammatory factor. Excessive TNF leads to inflammation, while too little impairs the immune system, says Sardi.

“We know that over-inhibition of TNF in humans increases the risk for lymphoma (cancer that originates in lymphocytes, a type of white blood cell),” says Sardi. [Therapeutics Clinical Risk Management 2007 Jun; 3(2):245-58] “When laboratory mice were given mega-dose resveratrol they did not live as long and largely succumbed to lymphoma. Resveratrol is a known TNF inhibitor,” adds Sardi. [Biochemical and Biophysical Research Communications 2008 May 2; 369(2):471-7]

Confusing dosage advice

While longevity seekers have been hearing a lot about resveratrol in the past four years, since an Ivy League university discovered it activated a longevity gene known as Sirtuin 1, advice concerning dosage has been confusing at times.

A 2006 mouse study suggested consumers would have to drink about 750 to 1500 bottles of red wine a day to live longer (24 milligrams per kilogram of body weight), but the longevity effect was only demonstrated among mice engorged with a fat-laden diet (60% fat calories vs. 35% for the typical human diet), which isn’t a real-world example.

When the data on mice fed a standard calorie diet were analyzed and published in 2008 [Cell Metabolism. 2008 Aug; 8(2):157-68], ultra-high dose resveratrol (360 mg and 1565 mg, human equivalent dosage) actually stunted the lifespan of mice. So the public has been misled concerning dosage since 2006 [Nature 2006 Nov 16; 444:337-42], and may have never heard about the 2008 report, says Sardi.

Lower dose resveratrol accompanied by an array of other small molecules may be superior to resveratrol alone. According to a mouse study conducted by Longevinex(R), published in the September 2008 issue of Experimental Gerontology [2008 Sept; 43(9):859-66], far more longevity genes were activated in heart tissue by Longevinex (9-fold more) than plain resveratrol, at a dose that was 17-320 times lower than doses used in prior studies.

Synergism found

“A synergistic effect has been demonstrated with the array of antioxidant molecules provided in Longevinex(R), compared to resveratrol alone,” says Sardi. Other studies also corroborate that resveratrol works better when accompanied by other molecules, at lower doses. [Journal Medicinal Food 2008 Dec; 11:773-83; Translational Oncology 2008 March; 1:19-27; Life Science 2008 May 7; 82: 1032-9]

Sardi says longevity seekers often demand human lifespan studies, not realizing such a study would be impractical, taking 100 years to complete. Mouse longevity studies take about 3-4 years and cost more than a million dollars, so more economical gene array studies are performed and compared against a calorie restricted diet, which is a known intervention that prolongs life in all life forms. Longevinex(R) also sponsored an unpublished study showing it activated far more genes in brain tissue than plain resveratrol.

Longevinex(R) is a patent-applied-for matrix providing 250 milligrams of gene-controlling molecules (resveratrol, quercetin, rice bran IP6, ferulic acid, vitamin D), and is currently the only resveratrol-based dietary supplement to have been successfully studied in humans. Researchers at Appalachian State University found Longevinex(R) had superior antioxidant and anti-inflammatory action among endurance athletes compared to green tea molecules or quercetin alone.

Longevinex(R) is microencapsulated for stability and long-term shelf life, and is micronized to enhance absorption. Longevinex(R) contains no alcohol. Longevity seekers are invited to visit the website at www.longevinex.com

Source: Longevinex


Study on the Economic Value of Nursing

  • Author: Health Informer
  • Filed under: Health News
  • Date: Dec 27,2008

The American Nurses Association (ANA) is pleased to announce, on behalf of the larger nursing community, the release of a first of its kind study quantifying the economic value of nursing.

The study was conducted by the Lewin Group, supported by grants from Nursing’s Agenda for the Future, the ANA and a coalition of nursing associations dedicated to addressing nursing workforce issues. The research, first proposed in 2003 and published in the current issue of the journal Medical Care, is the result of years of analysis of data on the correlation between patient outcomes and nurse staffing levels. To read the complete article please visit www.lww-medicalcare.com.

“Nurses are a vital component to the health care system,” said ANA President Rebecca M. Patton, MSN, RN, CNOR. “This nursing funded study provides a model that shows how nurses affect the delivery of cost-effective, high quality care, and prevent adverse events.

This project was the culmination of years of research that could not have been possible without the tireless work and cooperation of The American Association of Critical Care Nurses, the American Association of Colleges of Nursing, the Oncology Nursing Society, the American Organization of Nurse Executives, and the 85 other nursing organizations who contributed to the project. I applaud their outstanding efforts, and commend them on this significant contribution to the nursing profession.”

The research culled findings from 28 different studies that analyzed the relationship between higher RN staffing and several patient outcomes: reduced hospital-based mortality, hospital-acquired pneumonia, unplanned extubation, failure to rescue, nosocomial bloodstream infections, and length of stay. The findings demonstrate that as nursing staffing levels increase, patient risk of complications and hospital length of stay decrease, resulting in medical costs savings, improved national productivity and lives saved.

“Estimates from this study suggest that adding 133,000 RNs to the acute care hospital workforce would save 5900 lives per year. The productivity value of total deaths averted is equivalent to more than $1.3 billion per year, or about $9900 per additional RN per year.” The additional nurse staffing would decrease hospital days by 3.6 million. More rapid recovery translates into increased national productivity, conservatively estimated at $231 million per year. “Medical savings is estimated at $6.1 billion, or $46,000 per additional RN per year. Combining medical savings with increased productivity, the partial estimates of economic value averages $57,700 for each of the additional 133,000 RNs.”

The research findings suggest significant policy related issues. First and foremost, healthcare facilities cannot realize the full economic value of professional nursing due to current reimbursement systems. Additionally, the economic value of nursing is “greater for payers than for individual healthcare facilities.”

The ANA is the only full-service professional organization representing the interests of the nation’s 2.9 million registered nurses through its 54 constituent member nurses associations, its 23 organizational affiliates serving 330,000 members of national nursing specialty organizations, and its workforce advocacy affiliate, the Center for American Nurses. The ANA advances the nursing profession by fostering high standards of nursing practice, promoting the rights of nurses in the workplace, projecting a positive and realistic view of nursing, and by lobbying the Congress and regulatory agencies on health care issues affecting nurses and the public.

Source: American Nurses Association


New Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist Demonstrates Rapid, Long-term Suppression of Testosterone – a hormone that stimulates prostate cancer growth.

Ferring Pharmaceuticals, USA today received approval from the U.S. Food and Drug Administration (FDA) for degarelix, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist, indicated for patients with advanced prostate cancer. Potential trade names are still under review with the FDA. Following issuance of a trade name, Ferring Pharmaceuticals, USA will immediately begin commercialization in the U.S. On December 18, the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMEA), recommended granting a marketing authorization for degarelix in Europe. Degarelix is awaiting approval in other key global markets. It is a milestone for the company and represents Ferring’s first global product launch.

Phase III studies showed that degarelix is at least as effective as leuprolide (Lupron Depot(R)) in sustaining castrate levels or lower of testosterone, and had a statistically significant faster reduction of testosterone. At Day 3 of treatment, 96% of degarelix patients achieved castrate levels of testosterone, compared with zero percent receiving leuprolide. By Day 14, 99% of degarelix patients achieved castrate levels of testosterone, compared with 18% receiving leuprolide.

In the clinical trial, prostate specific antigen (PSA) levels were also monitored as a secondary endpoint. PSA levels were lowered by 64% two weeks after administration of degarelix, 85% after one month, 95% after three months, and remained suppressed throughout the one year of treatment. These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.

Prostate cancer is known to grow in the presence of testosterone. Suppression of testosterone has been a treatment goal for advanced prostate cancer for many years. Surgical castration was the standard method of reducing testosterone from the 1940s until the mid-1980s when the earliest forms of medical castration, luteinizing hormone releasing hormone (LHRH) agonists, were introduced.

Degarelix is the only GnRH receptor antagonist approved by the FDA for the treatment of hormonally-sensitive advanced prostate cancer. Degarelix achieves medical castration differently than LHRH agonists, specifically by binding reversibly to GnRH receptors on cells in the pituitary gland, quickly reducing the release of gonadotropins and consequently testosterone.

“Degarelix was discovered in San Diego, developed by Ferring Pharmaceuticals in the U.S. and Europe, and in its pivotal Phase III study demonstrated both an immediate onset of action and a profound long-term suppression of testosterone and PSA,” commented Dr. Pascal Danglas, Executive Vice President Clinical & Product Development, at Ferring. “We are delighted to deliver a new treatment option for advanced prostate cancer to the medical community. Ferring has a considerable pipeline of urology products in development, and we expect to introduce additional treatment advances in the urology field in the near future.”

“Use of a GnRH receptor antagonist is a highly efficient way to stop the production of testosterone,” said Neal Shore, MD, FACS, Medical Director for Carolina Urologic Research Center, a clinical trial investigator and advisor to Ferring. “The approval of degarelix offers the medical community an effective alternative in the treatment of hormonally-sensitive prostate cancer. Now prostate cancer can be treated with immediate inhibition of the GnRH receptors, inducing rapid reduction of testosterone to castrate levels, and sustaining those levels over time, which are the goals of systemic therapy. When a patient has disease recurrence, it is always encouraging to clinicians and patients to see PSA levels fall so rapidly.”

Wayne Anderson, President and CEO Ferring Pharmaceuticals, USA added, “We are enthusiastically preparing to enter this therapeutic area of urology. We respect the challenges physicians and patients face in their fight against prostate cancer and hope that we can help them with this new treatment option. This is a big milestone for the U.S. operating unit, and we have been carefully preparing for over two years for this launch.”

Phase III Study Results

The 12-month, randomized, open-label, parallel-group Phase III study evaluated the efficacy and safety of degarelix compared with leuprolide administered monthly over one year of prostate cancer treatment. Patients with histologically confirmed prostate cancer were randomized to either degarelix or leuprolide: a degarelix subcutaneous (under the skin) injection of 240 mg for one month with monthly maintenance doses of 80 mg (n=207) or monthly intermuscular (into the muscle) injections of leuprolide depot 7.5 mg (n=201).

The primary endpoint was testosterone suppression to less than or equal to 50 ng/dL during monthly measurements from Day 28 to Day 364. Degarelix was at least as effective as leuprolide in achieving and maintaining castrate levels of testosterone.

Suppression of testosterone levels to less than or equal to 50 ng/dL occurred significantly faster in patients receiving degarelix than in those receiving leuprolide. At Day 3, 96% of patients demonstrated treatment response. In that same time period, none of the patients who received leuprolide demonstrated treatment response. Conversely, testosterone levels had increased by a median of 65% in 80% of those receiving leuprolide at Day 3.

Overall, the most commonly observed adverse reactions during degarelix therapy included injection site reactions (e.g. pain, erythema, swelling or induration), hot flushes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). 99% of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in 2% or less of patients receiving degarelix. Degarelix is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. Degarelix is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.

Prostate Cancer

Prostate cancer is the most common cancer, excluding skin cancers, and the second leading cause of cancer death in American men. About one man in six will be diagnosed with prostate cancer during his lifetime, and one in 35 will die of this disease.(1) Prostate cancer develops from cells in the prostate gland that begin to grow out of control. In most cases, prostate cancer grows slowly and can remain undetected throughout a man’s life, although it can grow and spread quickly.(2) The four types of standard treatment are: watchful waiting, surgery, radiation therapy, and hormone therapy, also called androgen deprivation therapy (ADT). Degarelix is a new form of hormone therapy that reversibly binds to the GnRH receptors, inhibiting the production of testosterone. By suppressing the production of testosterone, tumor growth is inhibited.(3)

References
1. American Cancer Society. What Are the Key Statistics About Prostate Cancer? http://www.cancer.org/; Last accessed 11/12/08.
2. American Cancer Society. Cancer Reference Information, Overview: Prostate Cancer. http://www.cancer.org/; Last accessed 11/12/08.
3. National Cancer Institute. Prostate Cancer (PDQ(R)): Treatment: Treatment Option Overview.
http://www.cancer.gov/cancertopics/pdq/treatment/prostate/patient/; Last accessed 11/12/08.

*Lupron Depot(R) (leuprolide acetate for depot suspension) is a registered trademark of TAP Pharmaceuticals Inc.

Source: Ferring Pharmaceuticals Inc.


United Healthcare Workers’ master agreement shows that workers’ unity–not top-down deals–is how working people win in today’s economy

More than 900 caregivers at ten nursing homes in Northern California will have a happy holiday after all, after staying united through nearly ten months of negotiations with Kindred Healthcare. On Friday, members of United Healthcare Workers (UHW) won a breakthrough three-year agreement that creates quality care committees to strengthen workers’ voice to advocate for their residents, provides substantial raises, and protects the right to organize for workers at ten non-union facilities.

“Quality care committees are unprecedented in the nursing home industry,” said Emma Penisini, a certified nursing assistant for eight years at Pacific Coast Care Center in Salinas. “Everyone’s so excited about this agreement. We all work hard to provide the best care we can, and now we have a stronger voice to make our nursing homes better for the people who need our care.”

The agreement includes:

  • Quality of Care committees to improve the quality of care for residents, with third-party mediation if necessary.
  • Substantial wage increases, with certified nursing assistants averaging more than $2.33 an hour more over the three year term.
  • Health insurance improvements that will bring all Kindred workers close to 95% employer contribution for premiums
  • Protection for workers at Kindred’s ten non-union nursing homes in California to have a free choice to form a union.
  • Successorship protection that guarantees recognition of caregivers’ union and their contract if facilities are sold
  • Subcontracting protection
  • Daily cancellation protection
  • Reopener in the second year to improve pension benefits

This victory shows that UHW’s strategy of member involvement and democracy is superior to the top-down “Alliance” strategy advocated by national SEIU President Andy Stern. Recent deals SEIU International has made with nursing homes in Southern California do not include many key standards won by UHW members, including wage scales, defined-benefit pension plans, successorship protections, a code of conduct for organizing non-union workers, and quality care committees to give workers a direct voice in resident care.

In the last five months, UHW members have won contracts with Mariner, Sava, Horizon West, and now Kindred Healthcare that protect workers’ right to form a union at 32 non-union nursing homes — far more than the number of homes UHW was allowed to organize under the national union’s failed Alliance strategy. Nursing home workers who join together in UHW will have full collective bargaining rights, unlike workers enrolled into “template agreements” under the Alliance model.

Despite caregivers’ unprecedented gains as members of UHW, national SEIU officials are preparing to force nursing home and homecare workers out of UHW against their will through a forced merger of local unions. The forced merger would move caregivers into a new union run by appointees accountable to Stern who would pursue the national union’s “Alliance” strategy that has resulted in inferior contracts. A recent SEIU “advisory vote” asked members to choose between two similar merger options with no way to reject the merger entirely. Caregivers boycotted the election and filed 125,000 protests, while only 28,000 votes were cast — less than ten percent of eligible voters.

“In hard economic times, working people get the short end of the stick if we don’t stick together,” said Maria Samuel, an elected member of UHW’s executive board, a shop steward, and a certified nursing assistant for 27 years at Golden Gate Healthcare Center in San Francisco. “The last thing we need is more top-down deals that shut us out of important decisions. We’re winning great contracts in UHW because healthcare workers are involved in every decision our union makes.”

Workers at nine of the ten Kindred Healthcare facilities will vote on the agreement Monday and Tuesday. Workers at Pacific Coast Care Center in Salinas ratified an identical agreement last Friday. The contract takes effect upon ratification and will cover the following facilities:

  • Pacific Coast Care Center, Salinas
  • Bay View Nursing and Rehabilitation Center, Alameda
  • Hacienda Care Center, Livermore
  • Fifth Avenue Healthcare Center, San Rafael
  • Santa Cruz Health Center, Santa Cruz
  • Tunnell Center, San Francisco
  • Golden Gate Healthcare Center, San Francisco
  • Lawton Healthcare Center, San Francisco
  • Nineteenth Avenue Healthcare, San Francisco
  • Victorian Healthcare Center, San Francisco

With more than 150,000 members, SEIU United Healthcare Workers-West is the fastest-growing healthcare union in the United States. We represent healthcare workers in all job classifications and all healthcare settings, including hospitals, homecare, nursing homes and clinics. Our mission is to achieve high-quality healthcare for all. www.seiu-uhw.org

Source: SEIU United Healthcare Workers-West


Stress-related Weight Gain Spikes With Financial Crisis

  • Author: Health Informer
  • Filed under: Health News
  • Date: Dec 24,2008

Naturopathic No Crave Diet author warns many turn to food for comfort during economy crisis

The global financial crisis of the past year has hurt Americans and Canadians in more than just their wallets. Trends show that as a result of increased stress, many are eating more than usual and losing their battle against the bulge even as they try harder to diet.

“I’ve been seeing nearly three new patients a day for months, and 90 percent of them have stress-related eating issues,” said Dr. Penny Kendall-Reed, a world-famous naturopathic physician and author who treats patients on how to utilize the brain and holistic measures for controlling food cravings without the unpleasant side-effects normally associated with dieting.

According to Dr. Kendall-Reed, as many people become more stressed about work stability and the economic downturn, they compulsively turn to food.

“Stress stimulates the hunger center in the brain, destabilizes our blood sugar, makes us resistant to our anti-hunger messengers, and reduces our levels of ‘happy hormone’ serotonin, all of which trigger cravings that inevitably lead to weight gain,” said Dr. Kendall-Reed.

Dr. Kendall-Reed should know; her revolutionary, research-based No-Crave Diet concept, co-authored with her husband Dr. Stephen Reed, helps people take back control of their weight by teaching them how to counter the biological process that makes us crave the wrong foods, effectively silencing the craving urge fueled by stress.

“A standard complaint I get from patients at a time like this is that their diets are not working,” said Dr. Kendall-Reed. “That’s simply because stress promotes storage of calories, particularly around the midsection, which is the most dangerous place to gain weight and the hardest to remove.”

Monitoring about 90 percent of her patients on the No-Crave Diet for six to eight weeks prior to when the financial crisis worsened in mid-October, Dr. Kendall-Reed noticed that they have continued to lose weight and report no recurrence of cravings.

Dr. Kendall-Reed frequently lectures in the U.S., Canada, and the Caribbean and come January 9, 2009 will be in Santa Monica, Calif. teaching how to beat the food cravings that lead to weight gain.

Dr. Penny Kendall-Reed

Dr. Penny is a specialist in weight loss and preventative health, and co-author, with husband Dr. Stephen Reed, of The No Crave Diet book and the national best seller, The Naturopathic Diet (and the more comprehensive book The New Naturopathic Diet). She travels extensively throughout Canada and the United States lecturing on weight loss and related diseases.

The Kendall-Reeds also co-authored: Healing Arthritis, The Complete Doctor’s Stress Solution, and The Complete Doctor’s Healthy Back Bible (voted a Chapters/Indigo recommended book in their “Trusted Advisor” series). Visit www.nocrave.com and www.pkrhealth.ca, for more information.


Satisfaction Surveys Show Ohioans Pleased with Skilled Nursing Facilities

  • Author: Health Informer
  • Filed under: Health News
  • Date: Dec 23,2008

Results More Useful than Federal Ratings, Says OHCA

Ohio’s skilled nursing facilities scored, on average, 88.23 on a 100-point scale in family satisfaction, according to data released today by the Ohio Department of Aging (ODA). The Ohio Health Care Association (OHCA), the state’s largest long-term care organization, applauded the agency for again seeking out the opinions of real consumers, pointing out that the survey results are a much more useful tool to evaluate the care provided by the state’s skilled nursing facilities than the federal government’s hastily released “Five-Star” rating system.

“We believe these surveys of families of actual patients present a clear picture of the quality services actually delivered in Ohio’s skilled nursing facilities,” said Peter Van Runkle, OHCA’s Executive Director. “By listening to the opinions of the people in the best position to judge the services our facilities provide, these independent surveys are a better measure of quality than a misleading ’star’ system based on an arbitrary and convoluted formula.”

Ohio’s Family Satisfaction Survey asks family members about their satisfaction with over 60 aspects of a facility’s services. The 2008 survey shows improved satisfaction compared to 2006 (88.23 versus 86.6). The 2008 survey was conducted between July and December by the Scripps Gerontology Center of Miami University, under contract with ODA. In 2007, ODA contracted for interviews of skilled nursing facility patients, which also showed high levels of satisfaction. The satisfaction questionnaires were developed by impartial researchers and tested to ensure their validity. The ratings are based on two key questions selected by the researchers: “Overall, do you like this facility?” and “Would you recommend this facility to a family member or friend?”

The satisfaction survey results show the inaccuracy of the Five-Star rating system rushed into public view last week by the federal Centers for Medicare and Medicaid Services (CMS). “CMS arbitrarily put their thumb on the scale by dictating that twice as many skilled nursing facilities have to be one-star as five-star,” said Van Runkle. “Then they distorted the formula even further by saying a facility can be rated two stars higher than another facility with the exact same inspection and clinical results just because it has higher staffing, and without considering what patients and families think of the care provided.” This caused such erroneous results as half or more of the skilled nursing facilities in certain Ohio counties being at the bottom of CMS’s five-star scale.” CMS did not wait to include customer satisfaction data, even though the agency has plans to collect it, and did not verify staffing data, despite its importance in the Five-Star formula.

“To sum it up, Five-Star tries to come up with a single star measure and then claims this one measure accurately describes each facility’s quality,” Van Runkle said. “This might sound like it would be helpful to consumers, but the results are extremely misleading.” He noted that Five-Star gives the state’s skilled nursing facilities more “one-star” ratings than other states, but the satisfaction survey shows families at these supposedly “poor” facilities are generally happy with the care delivered: a third of the one-star facilities even beat the 88.23 statewide satisfaction average.

“We recommend Ohio’s long-term care consumers use the Department of Aging’s online ‘Consumer Guide,’ which gives detailed data on survey results, quality measures, and most importantly, the opinions of actual consumers, and does it in a usable fashion,” Van Runkle continued. “Visits to the facility are indispensible, and talking to residents, their families, and staff is more important than rating systems. Even CMS says the Five-Star system should not be used to rule out facilities when conducting a search.”

Ohio’s Consumer Guide and additional information is available online at www.ltcohio.org, or by contacting the Ohio Department of Aging at 800-282-1206.

The Ohio Health Care Association is a non-profit association of more than 730 skilled nursing facilities, assisted living residences, and facilities for people with developmental disabilities, caring for nearly 59,000 Ohioans. It is the largest long-term care association in the state, and the only chartered Ohio affiliate of the American Health Care Association. For additional information please go to www.ohca.org.

Source: Ohio Health Care Association


The following is being issued by T. L. Kittle, CEO and founder of the Blue Diamond Foundation:

What would help most Americans achieve optimum health care?

Since many people living in the United States don’t have access to quality health care, this is a wish-list to President-Elect Obama of actions that can be taken in order to ensure quality health care for everyone in the New Year.

As many of those who are ill understand, having health insurance does not necessarily mean having access to good health care–the current business practices that the insurance companies are allowed to utilize often make the insurance company itself an obstacle to quality medical care.

So this is my Holiday Wish-List…not in any order of importance, but the list nevertheless.

  • Physicians should not need to get approvals from insurance companies for their orders. If lawyers don’t need to ask permission, why do physicians? Not only does the approval process create unnecessary waste, it harms lives in the delays.
  • Eliminate pre-existing conditions.
  • Reduce co-pays and deductibles to rates that are more affordable. Most people don’t realize how little their insurance actually covers until they become ill.
  • Create a ‘patient directs’ physician protection law. Because there are so many diseases that have false negatives on test results, not to mention diseases there aren’t even names for, the current system makes it very difficult for physicians to help these patients–they’re either afraid insurance won’t cover the services or they’re afraid of getting sued later in the medical malpractice system. There needs to be a waiver that patients can sign that says, “This is my body, and while standards of care indicate xyz, I would like this medical action and in discussion with my physician I accept responsibility for negative consequences.” While physicians know more about medicine, patients know more about their bodies. Many people are suffering unnecessarily simply because their physician’s hands are tied.
  • Pay physicians for the work they do–on par with attorneys. If physicians get a difficult case, very few want to take it because they aren’t being compensated for time on the job. Make it mandatory for insurance companies to provide compensation for x number of hours of research per patient and y number of phone calls per patient per calendar year. (10 hours of research, 25 phone calls?) Many people who are suffering horribly with an unusual case have a difficult time finding a physician simply because physicians can’t afford to take on a lot of difficult cases.
  • Work with major corporations to develop a new paradigm for health care. Many corporations are struggling to make profits, yet still want to provide quality health care for their employees. Develop a new national system, giving corporations the option to pay into a well thought-out health care plan that provides quality care at affordable rates, outside of the current private system model.
  • Stop hospitals from charging more to those without insurance than the insurance company rates. Many people are losing their homes for amounts that the insurance companies would pay $5,000.

This current connection between “health insurance” somehow means “good health care” is simply misleading, and very far from the truth in some cases. Developing a new health insurance system, in collaboration with private corporations and public interest groups, with government accountability, will help make affordable health care available to everyone.

As evident by the millions without health insurance and those with health insurance yet being denied much needed medical care, there needs to be created an entirely new paradigm in order to make available quality health care. Clearly, the evidence that the current system is malfunctioning is overwhelming.

Health for one is healthy for all–it’s time for this nation to take a stand by implementing a new approach.

If the major corporations would come together with the government and public interest groups to develop a new paradigm, the people of the United States might actually be able to access quality medical care when they need it, as they need it, without hassle or delay–something most people in this country have never experienced.

T. L. Kittle is the founder and CEO of the Blue Diamond Foundation, established to assist those who need access to quality medical care.


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