Global Measles Deaths Drop By 74 percent

  • Author: Health Informer
  • Filed under: Health News
  • Date: Dec 5,2008

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The Eastern Mediterranean region achieves measles goal three years early

Measles deaths worldwide fell by 74% between 2000 and 2007, from an estimated 750,000 to 197,000. In addition, the Eastern Mediterranean region* which includes countries such as Afghanistan, Pakistan, Somalia, and the Sudan has cut measles deaths by a remarkable 90% — from an estimated 96,000 to 10,000 — during the same period, thus achieving the United Nations goal to reduce measles deaths by 90% by 2010, three years early.

The progress was announced today by the founding partners of the Measles Initiative: the American Red Cross, the United States Centers for Disease Control and Prevention (CDC), the United Nations Foundation (UN Foundation), UNICEF and the World Health Organization (WHO). The data will be published in the 5 December edition of WHO’s Weekly Epidemiological Record and CDC’s Morbidity and Mortality Weekly Report.

“This achievement is a tribute to the hard work and commitment of countries in the Eastern Mediterranean region to combat measles,” said Dr Margaret Chan, WHO Director-General. “With only two years until the 2010 target date, I urge all countries affected by measles to intensify their efforts to immunize all children against the disease.”

The significant decline in measles deaths in the Eastern Mediterranean region was the result of intensified vaccination campaigns including several countries with hard-to-reach areas. In 2007, more than twice the number of children were immunized in the region through such campaigns as compared to 2006.

“There are thousands of health workers and volunteers from our Red Cross and Red Crescent family who deserve much of the credit for this success. They give their time to literally go door-to-door informing, educating and motivating mothers and caregivers about the critical need to vaccinate their children,” said Bonnie McElveen-Hunter, Chairman of the Board of the American Red Cross. “This mobilization helps us to consistently reach more than 90% of the vulnerable population and save countless lives.”

The African region was the largest contributor to the global decline in measles deaths, accounting for about 63% of the reduction in deaths worldwide over the eight-year period. In 2007, measles outbreaks occurred in a number of African countries due to gaps in immunization coverage, reinforcing the need to continue immunization support.

“It’s absolutely wonderful that so many children are off to a healthy start in life thanks to the progress we’ve made in combating measles through immunization,” said Dr. Julie Gerberding, CDC Director. “Other children’s lives are still at risk, however, so it’s time we refocus our attention on sustaining our immunization efforts in countries where rates are low.”

The progress in South-East Asia has been limited — with just a 42% decline in measles deaths. This is due to the delayed implementation of large-scale vaccination campaigns in India, which currently accounts for two thirds of global measles deaths. Political commitment in India is essential if the 2010 global goal is to be achieved.

“The progress that has been made shows what can be achieved through measles vaccination campaigns, but much more needs to be done,” said Ann M. Veneman, Executive Director of UNICEF. “It is a tragedy that measles still kills more than 500 children a day when there is a safe, effective and inexpensive vaccine to prevent the disease.”

The world’s success in reaching the 2010 measles goal depends on ensuring that all children receive two doses of measles vaccine including one dose by their first birthday, strengthening disease surveillance systems, and providing effective treatment for measles.

“Progress also depends on addressing the considerable funding gap,” said Kathy Calvin, Executive Vice President and Chief Operating Officer for the UN Foundation. “The shortfall stands at US $176 million for 2009-2010, of which US $35 million is urgently needed for 2009. With continued funding and increasing ownership and commitment of countries, we can sustain our progress and achieve our goal by 2010. We ask our supporters to stay with us and strongly encourage new supporters to join us in our effort to save lives.”

Background

The Measles Initiative is a partnership committed to reducing measles deaths globally. Launched in 2001, the Initiative — led by the American Red Cross, the United Nations Foundation, the U.S. Centers for Disease Control and Prevention, UNICEF and the World Health Organization — provides technical and financial support to governments and communities on vaccination campaigns and disease surveillance worldwide. The Initiative has supported the vaccination of more than 600 million children in more than 60 countries helping reduce measles deaths by 74% globally and 89% in Africa (compared to 2000).

Other key partners in the fight against measles include Becton, Dickinson and Company, the Bill & Melinda Gates Foundation, the Canadian International Development Agency, The Church of Jesus Christ of Latter-day Saints, the GAVI Alliance, the International Federation of Red Cross and Red Crescent Societies, the Izumi Foundation, the Kessler Family Foundation, Merck Co., the Vodafone Foundation, and countries and governments affected by measles.

* The countries in the WHO Eastern Mediterranean region are Afghanistan, Bahrain, Djibouti, Egypt, Iran (Islamic Republic of), Iraq, Jordan, Kuwait, Lebanon, Libyan Arab Jamahiriya, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Somalia, Sudan, Syrian Arab Republic, Tunisia, United Arab Emirates and Yemen.

Related links:

WHO Measles Fact Sheet: http://www.who.int/immunization/newsroom/measles/en/index.html

Weekly Epidemiological Record. Progress in global measles control and mortality reduction 2000-2007: http://www.who.int/wer/2008/en/

WHO/UNICEF Global plan for reducing measles mortality 2006-2010: http://whqlibdoc.who.int/hq/2005/WHO_IVB_05_11_eng.pdf



Health insurance premiums have slowed to less than half the growth rate from five years ago, yet higher costs, increased utilization and waste in the health care system continue to fuel underlying health cost increases, a new report released today finds.

Prepared by PricewaterhouseCoopers (PwC) on behalf of America’s Health Insurance Plans (AHIP), “The Factors Fueling Rising Healthcare Costs 2008″ examines the causes of rising health care costs and analyzes how health insurance premium dollars are being spent.

This is the third study prepared by PwC. The study found that premiums increased 6.1 percent from 2006 to 2007 as compared to 8.8 percent from 2004 to 2005 and 13.7 percent from 2000 to 2001. This is a 31 percent and 55 percent reduction respectively over the previous growth rates.

“Once again PwC’s report demonstrates that we have made strides in lowering costs, but more must be done to make health care more affordable and eliminate waste in the system,” said Karen Ignagni, President and CEO of AHIP. “Today, the AHIP Board put forward specific policies that are designed to reduce future cost increases by more than $500 billion over five years.”

The growth in health insurance premiums was driven by general inflation (46 percent), health care price increases in excess of inflation (30 percent), and increased utilization of services (25 percent).

The report also found that 87 cents out of every premium dollar go directly towards paying for medical services. Embedded within the 87 cents are the costs of medical liability and defensive medicine, which are estimated to be ten cents of the premium dollar.

Of the remaining premium dollar, four cents go to consumer services such as prevention, disease management, care coordination, investments in health information technologies and health support; provider support; and marketing. Six cents go to costs associated with government payments, regulation and claims processing and other administration. Health insurance plan profits comprise three cents of the premium dollar, unchanged since the last report.

The report found that physician spending accounts for 33 cents of the premium dollar and that it increased by 5.5 percent in 2007. Hospital inpatient spending amounts to 20 cents of the premium dollar and grew at a rate of 7.5 percent.

Fifteen cents of the premium dollar go to outpatient spending, which grew at the rate of 8.2 percent. The report noted that “This rapid and steady growth in outpatient diagnostic testing is in part driven by the practice of defensive medicine.”

The study found that prescription drugs account for 14 cents of the premium dollar and that drug spending increased 5.7 percent, compared to the double-digit jumps of recent years. The report suggests that health plans’ prescription benefit tools and techniques which have helped slow growth rates “offers lessons about strategies to restrain cost growth without harming quality.”

While the report points to lower health care costs, it does raise an important alarm about future health care spending — wasteful spending that adds no value or quality to the care patients receive. The report highlights the care coordination, chronic disease management, and prevention programs health plans have implemented to combat waste in the health care system. Additionally, it outlines other efforts to reduce waste such as increasing standardization and transparency; improving research on comparative effectiveness of treatments; reforming the medical liability system; promoting value based reimbursement; and enhancing health information technologies.

To view the entire PwC report, visit www.AHIP.org.

Source: America’s Health Insurance Plans



At Least 10 New Cellular Therapies Will Launch Over Next Decade, According to a New Report from Decision Resources

Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the cellular therapies drug market will experience robust growth in the United States over the next decade, reaching $1.5 billion in 2017. According to the new special report entitled Cellular Therapies, the launch of second-generation cellular therapies, the approval of novel stem-cell-based therapies and dendritic cell vaccines, and the continuous adoption of existing cellular products will drive this market to grow at an annual rate of least 31 percent in the United States from 2007 to 2017.

While market growth will be strong in the United States, new centralized regulations in Europe that take effect at the end of 2008 will introduce uncertainties for cellular therapies marketed in Europe, according to the report. Among emerging therapies, TiGenix’s ChondroCelect will be the first therapy to be reviewed under the new centralized European Medicines Agency guidelines.

The report forecasts that, of the 10 or more cellular therapies that will launch over the next decade in the United States and/or Europe, Dendreon’s Provenge will be the first market entrant following its approval for prostate cancer in 2009 in the United States. Another cellular therapy that will launch in the near-term, Osiris/Genzyme’s Prochymal, will garner sales of $235 million in 2017 for the treatment of Crohn’s disease, although its initial regulatory approval will be for graft-versus-host disease in 2010 in the United States and in 2011 in Europe.

“First-to-market cellular therapies have had disappointing sales performances to date,” said Irene Koulinska, M.D., analyst at Decision Resources. “However, researchers have made significant progress in the development of cellular therapies in recent years, despite facing considerable financial and ethical challenges. Additionally, the availability of noncontroversial cell sources and the establishment of a regulatory framework in the United States and Europe have prompted increased interest among large biomedical companies in the development and commercialization of cellular therapies.”

Source: Decision Resources



Consumers Uncertain About Their Medical Diagnosis and Treatment

  • Author: Health Informer
  • Filed under: Health News
  • Date: Dec 3,2008

Clinical Case Reviews Reveal Deficiencies in Care for Individuals across the Country

Members who recently sought expert medical consultations from Best Doctors, Inc., expressed deep uncertainty about their initial diagnosis or course of treatment, according to data released today.

The findings are based on clinical reviews of cases of Best Doctors members. Best Doctors is a unique health benefit that calls upon top medical specialists to help members navigate critical decisions about their care.

More than 500 members in the United States voluntarily called Best Doctors for help during the second quarter of 2008. Of those:

  • 25 percent said they needed help choosing among treatment options;
  • 23 percent questioned whether they needed surgery;
  • 16 percent were skeptical of their doctor;
  • 15 percent didn’t understand their diagnosis;
  • 14 percent felt their symptoms were not improving; and,
  • 7 percent had no firm diagnosis to guide their treatment.

“There is tremendous uncertainty among consumers about whether they are getting the right diagnosis and treatment,” said Evan J. Falchuk, president and chief operating officer of Best Doctors. “Consumers face hard decisions that impact their lives, as well as the bottom line of employers who pay for their care. Certainty is the one thing people want most when they make tough medical decisions, but it’s harder and harder to attain.”

Members had legitimate reasons to be anxious about the quality of their care, according to Best Doctors, which offers its service through public and private employers.

The initial diagnosis and treatment received by members was incorrect or inadequately supported in more than two-thirds of the cases. Diagnosis and treatment plans changed after Best Doctors expert clinical case reviews uncovered:

  • Insufficient work-ups in 31 percent of cases;
  • A more effective treatment strategy in 25 percent of cases;
  • Incorrect interpretations of pathology or diagnostic tests in 12 percent of cases; and,
  • The treatment was causing patient symptoms in 5 percent of cases.

Falchuk said the complexity of medicine, easy access to conflicting medical information and advice, and the increasing workload of physicians all play a role in fueling consumer uncertainty around diagnosis and treatment, as well as in missteps that lead to incorrect clinical recommendations.

“Our track record shows that the initial diagnosis needs to be changed for one in five members and that treatment needs to be altered for three in five,” Falchuk said. “Providing expert medical consultation creates certainty that has a direct and immediate impact on the quality and cost of care. It puts members on a path to better health and it saves money for their employers.”

Conditions involving cardiovascular and pulmonary diseases accounted for 19 percent of the cases handled by Best Doctors during the second quarter; followed by oncology, neurology and orthopedics and trauma at 16 percent each; rare genetic diseases, immunology and infectious diseases, and skin, eye, ear, nose and throat conditions at 9 percent each; and, nephrology and endocrinology at 6 percent each.

Source: Best Doctors, Inc.



British Medical Journal study finds natural, less expensive treatments are effective for Irritable Bowel Syndrome Sufferers

With its feasts, travel and family gatherings, the holiday season is, for most, anticipated with excitement. But for the estimated 60 million Americans who suffer from Irritable Bowel Syndrome (IBS), the holidays can be fraught with the fear of sudden embarrassing and debilitating gastrointestinal attacks, often triggered by food or stress.

IBS is the most common chronic health disorder in the U.S. with symptoms that include abdominal pain, cramping, bloating, gas, diarrhea, and/or constipation. IBS has no known cure and expensive prescription drugs have disappointed millions with life threatening side effects and recalls.

In new analysis appearing in the British Medical Journal in November, researchers reexamined relatively inexpensive, safe, and readily available therapies as treatments for IBS. The article reviewed 38 studies involving more than 2,500 volunteers and found three treatments — peppermint oil, antispasmodic drugs and soluble fiber — to be effective. The study also indicated that significantly more people obtained some relief from peppermint oil (the most effective remedy in the analysis) than from fiber, the most common doctor-recommended remedy.

The new report is reawakening interest in natural, less expensive and side effect-free treatments for IBS like IBSuppress(R) Stabilizing Tablets, which can help manage and limit the condition’s impact on quality of life. Designed for sufferers who are prone to urgency-related symptoms and diarrhea, IBSuppress(R) contains a proprietary blend of natural ingredients including peppermint oil, ginger and fennel - which are all antispasmodic herbs.

“Research shows that these herbs fight spasms, relieve pain, reduce gas and aid digestion,” says IBSuppress(R) director of marketing Jamie Miller. “Our goal is to help IBS sufferers manage their condition and improve their quality of life, especially when they are away from home.”

IBSuppress(R) Stabilizing Tablets are sold by DWD Consumer Products, Inc. and are available in boxes of 30 chewable tablets. They can be purchased on the company’s website www.ibsuppress.com for $7.99, and at select retailers. Tablets can be taken anytime, anywhere to help maintain normal bowel function or at the first sign of an unsettled system. Sufferers are advised to consult with their physician before taking any medication, supplement or medical food.

Source: DWD Consumer Products, Inc.



Study: Patient Harm More Common with Patient-Controlled Pain Medication

  • Author: Health Informer
  • Filed under: Health News
  • Date: Dec 2,2008

Intravenous patient-controlled analgesia (PCA) allows patients to control their own pain medication, but a new study published in the December 2008 issue of The Joint Commission Journal on Quality and Patient Safety shows that errors related to this practice are four times more likely to result in patient harm than errors that occur with other medications.

The study of more than 9,500 PCA errors over a five-year period in the United States showed that patient harm occurred in 6.5 percent of incidents, compared to 1.5 percent for general medication errors. The PCA errors examined also were more severe — harming patients and requiring clinical interventions in response to the error — than other types of medication errors. Most errors involved either the wrong dosage or the wrong drug caused by human factors, equipment or communication breakdowns. For example, one case involved a patient who received several 10 mg doses instead of 1 mg medication doses after surgery because of an incorrectly programmed dispensing pump. The PCA errors examined also were more severe — harming patients and requiring clinical interventions in response to the error — than other types of medication errors.

“The entire PCA process is highly complex,” says the study’s lead author Rodney W. Hicks, Ph.D., M.S.N., M.P.A., UMC Health System Endowed Chair for Patient Safety and Professor, Anita Thigpen Perry School of Nursing, Texas Tech University Health Sciences Center, Lubbock, Texas. “PCA orders must be written, reviewed and then accurately programmed into sophisticated delivery devices for patients to be pain free. Such complexity makes PCA an error prone process. Health care organizations should now plan to make the process safer.”

Through this method, a patient can administer doses of pain medication with the push of a button. A computerized pump that contains a syringe of doctor-prescribed pain medication is connected directly to a patient’s intravenous (IV) line. PCA can be used to relieve pain after surgery or for other chronic pain conditions. Harm associated with PCA errors can include respiration suppression, inadequate pain relief and patient death.

Data for the study came from voluntary reports to the United States Pharmacopeia (USP)’s MEDMARX Program, and shows that more than 60 percent of the hospitals anonymously reporting medication errors through MEDMARX had at least one PCA error. The study — “Medication Errors Involving Patient-Controlled Analgesia” — is important because preventing PCA errors “would yield substantial gains in patient safety,” the authors conclude.

To reduce PCA errors, Dr. Hicks and the co-authors recommend three strategies:

  • Simplify the technical equipment used in PCA. The study shows that the PCA process is heavily dependent on the ability of caregivers to execute sequential tasks successfully, so easy-to-follow setup instructions for equipment could reduce errors. The study urges PCA vendors to look for ways to make it less likely that programming errors will lead to a wrong dose.
  • Use bar codes and an electronic medication administration record to reduce errors that involve the wrong medication. Independent double-checks of the PCA orders, the product and the PCA device settings should be standard practice, the study advises.
  • Ask pharmacists to design easily understood and standardized forms for PCA, and ensure that prescribers use only these standardized forms. These actions would address communication problems that lead to errors and bring regional standardization to the PCA process.

In 2004 The Joint Commission issued a Sentinel Event Alert (www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_33.htm) that identified root causes of patient-controlled analgesia errors and contained recommendations for reducing errors.

The Joint Commission Journal on Quality and Patient Safety, published monthly by Joint Commission Resources, features peer-reviewed research and case studies on improving quality and safety in health care organizations. Click here to order this article in the December 2008 issue: http://www.ingentaconnect.com/content/jcaho/jcjqs

To subscribe to The Joint Commission Journal on Quality and Patient Safety, please call JCR Customer Service toll-free at 800-746-6578, or visit www.jcrinc.com.

Joint Commission Resources, Inc. (JCR), a not-for-profit affiliate of The Joint Commission, has been designated by The Joint Commission to publish publications and multimedia products. JCR reproduces and distributes these materials under license from The Joint Commission. JCR educational programs and publications support the accreditation activities of The Joint Commission, but are separate functions. Attendees at JCR educational programs and purchasers of JCR publications receive no special consideration or treatment in, or confidential information about, the accreditation process. Learn more about Joint Commission Resources at www.jcrinc.com.



Faster, 24×7 Access to Medical Data Enables Clinicians to Deliver Better Care to Cancer Patients

EMC Corporation, the world leader in information infrastructure solutions, announced that the Cancer Treatment Centers of America (CTCA), a national network of cancer treatment hospitals and community oncology programs, has successfully implemented an EMC information infrastructure to support its comprehensive electronic health record (EHR) initiative. EHRs, digital files containing patient medical data, enable physicians to increase efficiency and better serve their patients. By implementing EMC technology to support this initiative, CTCA has achieved more responsive patient care, faster and uninterrupted access to medical data and increased operational efficiency. In addition, massive storage and server consolidation and automation of data recovery, backup and restore functions have enabled CTCA to manage its growing information infrastructure more cost-efficiently and without adding storage administrative staff.

Chad Eckes, Chief Information Officer, CTCA, said, “We’ve fully embraced the EHR because of its potential to help improve patient care and safety more than any other IT initiative. Unlike the traditional approach of incrementally adding new applications and IT components to achieve an EHR, CTCA engineered a complete transformation of our IT application architecture all at once. We now have a cohesive, centralized system that integrates every aspect of a patient’s care and delivers unprecedented information security and availability.”

“The EHR is already running in our three existing cancer hospitals, and we’ll extend the benefits even further when we open our first all-digital hospital in Phoenix in December 2008. The CTCA system will help CTCA enhance each patient’s treatment experience from the point of admission forward. Everything from viewing medical history in the operating room to submitting insurance claims to filling prescriptions will be done electronically.”

To launch the EHR project, CTCA replaced storage directly attached to its servers with a centralized EMC CLARiiON(R) storage area network (SAN). CTCA also deployed several new applications, such as Eclipsys Sunrise Clinical Manager (SCM) and Microsoft Office SharePoint Server, as well as integrated existing applications, such as Lawson enterprise resource planning software and Microsoft Exchange email, and into the new infrastructure.

“Each year, we are adding vast quantities of new medical data and clinical applications online; EMC’s SAN has enabled us to scale smoothly to storage capacities that have grown by 600% to 60 terabytes in less than two years,” said Eckes. “Even though the environment is significantly bigger and more diverse, we’ve been able to maintain our storage needs with a team of two employees who manage all of the SAN, replication and backup support on a part-time basis. With the SAN’s ease of use and simplified management, we’re able to do a lot more with the same amount of resources.”

In the latest phase of its EHR deployment, Schaumberg, Ill.-based CTCA implemented EMC RecoverPoint to replicate all of its clinical and administrative information stored on the EMC CLARiiON to another CLARiiON located at a remote datacenter 40 miles away.

Rakesh Patel, Director of Infrastructure and Security, CTCA, said, “We use EMC to replicate new data every second so our clinicians always have a current view of a patient’s status. If our datacenter failed, we would recover from clean data as opposed to data that is hours old. We also can bring up our production systems at our remote site in less than two hours compared with the three to four days a recovery used to take us.”

In addition, VMware(R) virtualization solutions have contributed to improving CTCA’s information availability. With VMware, CTCA was able to consolidate 70 percent of its physical servers as virtual machines, reducing the number of physical servers. CTCA utilizes RecoverPoint to replicate the virtual machines stored on the EMC CLARiiON and to integrate with VMware Site Recovery Manager to automate the recovery process in case of a site failure. If a virtual machine needs more resources than is being provided, CTCA uses VMware’s VMotion to move the virtual machine from one physical server to another - online, and without service interruption. In addition, if a physical server fails, VMware High Availability automatically fails over the virtual machines to operational servers.

Patel said, “That consolidation alone contributes to a more reliable environment because there is less complexity. And, using VMware and EMC recovery tools together ensures that our physical and virtualized environments can be centrally managed and well protected.”

CTCA also uses EMC NetWorker(R) software to back up its entire production environment to an EMC Disk Library 4100, which is replicated to another Disk Library. The disk backups are eventually ported to tape for longer-term storage.

Patel said, “It used to take 12 hours to back up 1.8 terabytes to tape. With NetWorker and Disk Library, we back up more than twice that much data in less than four hours. In a 24-hour operation like a hospital, it’s crucial to get the data backed up quickly so it’s not slowing down the applications.”

Source: EMC Corporation



FDA Accepts Cell Therapeutics’ Zevalin sBLA and Grants Priority Review

  • Author: Health Informer
  • Filed under: Health News
  • Date: Dec 1,2008

May Accelerate First-line Launch by Four Months

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review, and has granted priority review status for, the supplemental Biologics License Application (sBLA) for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin’s lymphoma who achieve a response to first-line therapy. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need. A Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009 has been established by the FDA for a decision regarding the approval of the Zevalin sBLA. If approved, Zevalin would be the first radioimmunotherapy available to patients as first-line consolidation therapy. It is estimated that there would be approximately 18,000 additional patients that currently receive first-line treatment which would potentially be eligible to use Zevalin under the proposed expanded label.

CTI and Spectrum Pharmaceuticals, Inc. entered into an agreement to form a 50/50 owned joint venture, RIT Oncology LLC, on November 26, 2008 to commercialize and develop ZEVALIN in the United States and expects the transaction will close in early December, 2008. CTI initially acquired the US rights to Zevalin from Biogen Idec in December 2007. CTI gained access to the First-line Indolent Trial (FIT) data through an agreement with Bayer Schering Pharma AG, Germany who used the data to obtain approval for Zevalin as first-line consolidation treatment in Europe.

“We are pleased that the FDA, by granting the application priority review status, acknowledges that the use of Zevalin in the first-line consolidation setting could represent an important treatment option for follicular B-cell non-Hodgkin’s lymphoma patients,” said James A. Bianco, M.D., CEO of Cell Therapeutics. “In addition to shortening the timeframe for FDA review from 10 months to 6 months, it would also enable physicians to get this drug to those who may benefit from it sooner. If approved, it also pushes up our anticipated timeline for commercial launch for first-line indication by 4 months which should result in a substantial increase to our revenue forecast in 2009.”

Zevalin is currently approved in the United States for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL), including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival.

About First-Line Consolidation Therapy

Consolidation therapy is a treatment given after initial induction therapy and is aimed at improving the quality of the patient response by further diminishing the number of cancer cells with the goal of extending the response duration.

About the Phase III First-line Indolent Trial (FIT)

The multinational, randomized phase III First-line Indolent Trial (FIT) evaluated the benefit and safety of a single infusion of Zevalin in 414 patients with CD20-positive follicular non-Hodgkin’s lymphoma who had achieved a partial response or a complete response after receiving standard first-line chemotherapy regimens. The FIT trial results were presented for the first time in one oral and three poster presentations at the American Society of Hematology (ASH) conference in December 2007. The FIT trial demonstrated that when used as a first-line consolidation therapy for patients with follicular non-Hodgkin’s lymphoma, Zevalin significantly improved the median progression-free survival time from 13 months (control arm) to 37 months (Zevalin arm) (p<0.0001).

The primary investigators of the study concluded that Zevalin consolidation of first remission in advanced stage follicular non-Hodgkin’s lymphoma is highly effective, resulting in a total complete response (CR + CRu) rate of 87 percent and prolongation of median progression-free survival (PFS) by approximately two years, with a toxicity profile comparable to that seen with Zevalin’s use in approved indications. Zevalin-treated patients had reversible Grade 3 or 4 hematologic side effects including neutropenia in 67 percent, thrombocytopenia in 61 percent, and anemia in 3 percent of patients. Nonhematologic toxicities were 24 percent Grade 3, 5 percent Grade 4, and Grade 3/4 infection was 8 percent.

Zevalin(R)

Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan(R)) infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.

Patients and healthcare professionals can visit http://www.zevalin.com/ for more information.

Source: Cell Therapeutics, Inc.



UK boost for South Africa in new struggle against AIDS

  • Author: Health Informer
  • Filed under: Health News
  • Date: Nov 30,2008

South Africa’s revitalised drive against AIDS today received a £15 million boost which could help save millions of lives and stop the spread of HIV across the country.

International Development Minister Ivan Lewis travelled to Johannesburg ahead of World AIDS Day to offer the new South African Health Minister, Barbara Hogan, direct UK support as she embarks upon a new drive to tackle the HIV epidemic.

Ms Hogan’s recent appointment has signalled a significant change in direction in the fight against HIV and AIDS after years of inaction, misinformation and denial.

Ivan Lewis said:

“For too long, South Africa has been fighting AIDS with its hands tied behind its back - with over 5.5 million people living with HIV. Those ties have now been removed and the country has a real opportunity finally to turn the tide in its struggle against this epidemic.

“Barbara Hogan has set a bold and exciting vision on HIV and AIDS and that is why the UK is fully committed to working with her as she embarks on this new approach. We must ensure this new direction is irreversible and that there are no more lost opportunities to save lives.

“If we manage to control and then reverse HIV and AIDS in South Africa there will be a positive knock-on effect across Southern Africa and the continent. I call on the people of South Africa to unite behind this effort and finally call time on the HIV epidemic.”

The UK support plan will help South Africa deliver:

  • More protection for mothers and babies. There will be an increase in the availability of free tests for mothers during pregnancy, and anti-HIV drugs for pregnant mothers and children. Isolated and rural areas will be specifically targeted. It is estimated that over 45,000 lives could be saved every year.
  • National HIV awareness campaign. Information on safe-sex and HIV health issues will be sent out via radio, newspaper, text messages and street posters. The multi-media campaign is expected to reach 9 in 10 South Africans - over 43 million people.
  • Better nurses, doctors and clinics. Medical staff and managers will be helped to improve the quality of advice and service to patients, and staff morale improved through stronger incentives for quality care. Training will be offered to improve the quality and efficiency of services.
  • HIV and AIDS ‘watchdog’. The National AIDS Council (SANAC) will be strengthened and given a clearer remit to hold all parts of government to account, as well as frontline agencies involved in tackling HIV and delivering health services.

South Africa has the highest burden of AIDS in the world. Over 2.5 million people have died and over 5.5 million people in South Africa are living with HIV. Every day 800 people die from AIDS and 1500 people are infected with HIV - around one person every minute.

In the past the South African national response to AIDS has been severely hampered by “denialism” - the disproven theory that HIV does not cause AIDS.

The new awareness campaign “Small Acts, Many People, Big Change: We shall overcome” will be kick started by Barbara Hogan on Friday after the SANAC meeting. It will lead to and culminate in a minute’s silence followed by a national work stoppage on World AIDS Day to start a national conversation on AIDS.

The UK is a leader in the global effort to tackle AIDS. In South Africa, DFID Is concluding a major 5-year programme on AIDS and has spent £30 million to strengthen AIDS responses at national and provincial level. A new 5-year programme will start in mid-2009.

DFID, the Department for International Development: leading the British government’s fight against world poverty. One in five people in the world today, over 1 billion people, live in poverty on less than one dollar a day.

Website: www.dfid.gov.uk

Source: Department for International Development



eTIPs - electronic-Targeted Intervention for Psoriasis

  • Author: Health Informer
  • Filed under: Health News
  • Date: Nov 29,2008

Psoriasis affects 2-3% of people in the UK and can create both physical and psychological distress. Psychological discomfort is made worse by the visible nature of the condition whereby some people avoid exposing their skin and avoid social activity due to embarrassment. The University of Manchester has embarked on a PAPAA (Psoriasis and Psoriatic Arthritis Alliance) funded study to help people manage psoriasis better. The research team includes skin and psychology experts Professor Chris Griffiths, Professor Nick Tarrier, Dr. Christine Bundy, Ms. Binder Kaur and Dr. Sandra Bucci.

The team has designed a program, known as eTIPs (electronic-Targeted Intervention for Psoriasis). This is a web-based programme for people with psoriasis which aims to reduce psychological distress and improve psoriasis, help with coping and managing psoriasis better, improve quality of life, and increase feelings of confidence and positive thinking. Participants will complete the web-based therapy over a six week period and will be required to complete questionnaires at 3 or 4 different time points (including a six month follow-up).

e-TIPs is offered to individuals diagnosed with plaque psoriasis, who are 16 years or over, have working knowledge of the English language, and have internet access. It will be delivered on-line so that it is widely available, and can reach out to individuals who may not wish to discuss psychological complaints face-to-face. Participants can take part at their own convenience and in the privacy of their own home, and can also work at their own pace.

This study which began recruiting people in the autumn 2008 will run until December 2009.

Look out for recruitment announcements via the PAPAA website (http://www.papaa.org ) and local newspapers, radio and clinics (in Manchester only).

PAPAA:

PAPAA was founded in 2007, as a joint venture between the Psoriatic Arthropathy Alliance (PAA) (Reg Charity No: 3055414), and the Psoriasis Support Trust (PST) (Reg Charity No: 1088359), with the aim of merging the original charities into a single entity, becoming a principle resource of information and help for people with psoriasis and psoriatic arthritis in the UK.

The Psoriasis and Psoriatic Arthritis Alliance (PAPAA) is a Registered Charity No: 11188192. A Company Limited by Guarantee, registered in England and Wales No: 6074887 Registered Office: Acre House 11-15 William Road London NW1 3ER.

Source: PAPAA



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