Medicare Launches Medicare PHR Choice Pilot – Offers Beneficiaries An Opportunity To Maintain Their Own Personal Health Records
The Centers for Medicare & Medicaid Services (CMS) today announced the launch of the Medicare PHR Choice Pilot in Arizona and Utah.
This pilot program will offer beneficiaries with Original Medicare the opportunity to choose one of the personal health record (PHR) products offered by the companies selected for the pilot. PHRs will allow beneficiaries to maintain their health record information electronically and Medicare will add claims data directly to the PHRs for this pilot.
“With up-to-date, accurate and accessible personal health records, Medicare beneficiaries avoid the pitfalls of paper records by having critical information available when they need to make health care decisions,” U.S. Department Health and Human Services Secretary Mike Leavitt said.
“This pilot provides beneficiaries with a choice of products to meet their individual needs,” HHS Deputy Secretary Tevi Troy said at a news conference and partners meeting in Salt Lake City, Utah, while launching the pilot.
CMS’ contractor, Noridian Administrative Services (NAS), is coordinating this pilot program. The selected PHR companies offer beneficiaries a range of product choices, including ones that are free as well as ones that offer “concierge” services, for an extra fee, with additional features such as adding notes from health care providers and other sources of health information.
PHRs are tools that can help consumers keep track of information that will make it easier to manage their health and health care services. A PHR is a record of health information that is under the control of the consumer. Sometimes it only contains data entered by the individual, but it can also include information from his or her provider or from a health plan – as in this pilot, where, if the consumer requests it, Medicare will transfer health information from its claims database directly to the individual’s PHR.
A PHR, which is controlled by the consumer, is different than an electronic health record (EHR), which is owned by and under the control of the physician. A PHR will only contain data entered by the consumer or from sources from which the consumer requests information such as his or her health plan or health care provider.
Through this pilot beneficiaries who select one of the PHRs offered by the participating PHR vendors can choose to add additional personal health information to supplement the information provided by Medicare. Depending on the specific product, beneficiaries may be able to authorize links to other personal electronic information such as pharmacy data.
PHRs also may offer links to tools that help consumers manage their health, such as wellness programs for tracking diet and exercise, information about drugs and medical devices, health education information, and applications that detect potential medication interactions. Beneficiaries can elect to allow family members, health care providers, or whomever they choose to have access to their PHR. This access can allow caregivers to help manage a loved one’s health or provide information that could be important to a physician caring for you in an emergency.
Each company has privacy and security standards to protect the information transmitted and stored in its PHR records. More information on the specific security and privacy policies of each of the participating companies can be found on their respective websites.
CMS Acting Administrator Kerry Weems said “We encourage beneficiaries to consider whether a PHR is right for them. We hope our beneficiaries in Arizona and Utah will take advantage of this opportunity to establish a PHR that will be populated with their Medicare claims data.”
More information about the Medicare PHR choice pilot can be found on http://www.medicare.gov/phr.
Centers for Medicare & Medicaid Services
Human Beta Cells Can Be Easily Induced To Replicate, According To Pitt Study In Diabetes
Researchers at the University of Pittsburgh School of Medicine have successfully induced human insulin-producing cells, known as beta cells, to replicate robustly in a living animal, as well as in the lab. The discovery not only could improve models and methods for studying diabetes, but also opens up new possibilities for treating the condition.
“Most scientists thought that these important pancreatic cells could not be induced to regenerate, or could only replicate very slowly,” explained senior author Andrew F. Stewart, M.D., professor of medicine and chief of the Division of Endocrinology and Metabolism at the University of Pittsburgh School of Medicine. “This work provides proof-of-principle that the production of human beta cells can be stimulated, and that the newly generated cells function effectively both in the lab and in a living animal.”
The findings are in the early online version of Diabetes, one of the journals of the American Diabetes Association.
Lead authors Nathalie Fiaschi-Taesch, Ph.D., assistant professor in Pitt’s endocrinology division, and Todd A. Bigatel, M.D., a graduate of the postdoctoral fellowship program, identified molecules that play key roles in human beta, or islet, cell replication, building on previous work conducted by co-author Irene Cozar-Castellano, Ph.D., also an instructor of endocrinology, who performed similar studies using mouse cells.
They found that, unlike rodents, human beta cells contain a significant amount of a protein called cdk-6. When cdk-6 production was increased using a viral vector carrying the cdk-6 gene, the cells replicated. Stimulation was further enhanced by increasing production of another cell cycle molecule called cyclin D1. Untreated human islets did not replicate.
“After we transplanted some of these engineered human beta cells under the outer layer of a kidney in a diabetic mouse, we saw that replication continued and blood sugar levels normalized,” explained Dr. Fiaschi-Taesch. “When we took out the kidney that contained the insulin-producing cells, the mouse immediately developed diabetes again.”
The prospect of being able to study human beta cells and their replication in vivo, meaning in a living animal, could greatly improve diabetes study models, and could lead to techniques to generate new beta cells in patients with diabetes. In the future, it also could allow more effective therapeutic transplants of insulin-producing cells – either by expanding the numbers of cells available from a single cadaveric donor or from a gene-enhanced version of the patient’s own cells, or by establishing permanent cell lines from existing beta cells or stem cells, Dr. Stewart pointed out.
He added that cell cycle replication molecules might also be targets for drugs that could transiently turn on beta cell replication to increase insulin production.
The team’s work was funded by grants from the National Institutes of Health, the American Diabetes Association and the Juvenile Diabetes Research Foundation.
The University of Pittsburgh School of Medicine is one of the nation’s leading medical schools, renowned for its curriculum that emphasizes both the science and humanity of medicine and its remarkable growth in National Institutes of Health (NIH) grant support, which has more than doubled since 1998. For fiscal year 2006, the University ranked sixth out of more than 3,000 entities receiving NIH support with respect to the research grants awarded to its faculty. As one of the university’s six Schools of the Health Sciences, the School of Medicine is the academic partner to the University of Pittsburgh Medical Center. Their combined mission is to train tomorrow’s health care specialists and biomedical scientists, engage in groundbreaking research that will advance understanding of the causes and treatments of disease and participate in the delivery of outstanding patient care.
University of Pittsburgh School of Medicine
Rising Student Debt Presents Biggest Challenge To Increasing Social Mobility In Medicine, Warns BMA, UK
Rising levels of medical student debt could derail government plans to increase social mobility in medicine, the BMA said.
Responding to the publication of the government’s “The New Opportunities White Paper”, medical student leaders warn that despite some positive proposals, ministers must make alleviating the soaring debt levels faced by students their priority if they wish to enhance social mobility into the medical profession.
Louise McMenemy, a member of the BMA’s medical students committee and lead on widening participation in medicine, said;
“The White Paper contains a number of positive proposals. Enhancing support to child development schemes and increasing the number of Professional and Development Loans are encouraging announcements. The establishment of a specific Panel to examine access to the professions is also a good step forward, though it is worrying that it appears there will be no representative from the medical profession.
“However, the spectre of debt hangs over the government’s entire social mobility agenda. At present medical graduates leave university with £21,000 worth of debt on average, a figure that could rise as high as £37,0001 in the next few years now that variable top up fees have been introduced.
“Students are already relying on their parents, credit cards, overdrafts and loans to get them through university, despite many holding down part-time jobs.
“In view of this worrying situation the BMA remains concerned that talented individuals from lower socio-economic backgrounds will either be discouraged or simply unable to pursue a career in medicine because of the spiralling debt burden. This would represent a terrible loss to the NHS and to patients, as well as to the individuals themselves.
“While today’s measures contain some notes of optimism, the government and the recently established Panel on Access to the Professions must ensure that it tackles this mounting debt problem as a matter of priority. Increasing bursary opportunities to less well off students, simplifying the application system for financial support and maintaining the cap on tuition fees are three important first steps.”
“If the government fails to lift the debt burden bearing down on medical students its social mobility agenda will fail.”
1. Figures from the BMA’s Need for Change document: here.
The Government’s New Opportunities White Paper is available on the Cabinet Office website:
http://www.hmg.gov.uk/newopportunities.aspx
The BMA has produced a report outlining key equality and diversity issues in medical education, Demography of medical schools: a discussion paper. An update of this report is due in May 2009.
See Here.
British Medical Association
BMA House
Tavistock Square
London
WC1H 9JP
http://www.bma.org.uk
Divided We Fail Launches Next Phase Of National Campaign To Fix America’s Health And Economic Crises
Today leaders of the country’s top consumer, business and labor groups launched the next phase of Divided We Fail, a national movement to bring health and financial security to every American.
Joining with Business Roundtable, the National Federation of Independent Business (NFIB) and Service Employees International Union (SEIU), AARP is hosting more than 50 events in nearly every state to educate and engage the public about issues of health reform and economic security. Divided We Fail will also present to lawmakers more than 1.6 million pledges signed by supporters from across the country.
“The last two years have been an important platform for the real work that begins today,” said AARP CEO Bill Novelli. “We want Divided We Fail to be the catalyst for real health and economic reform. The president-elect and new Congress have hit the ground running this month, and we’re here to help with the support of 53 million consumers, workers and entrepreneurs.”
Since its formation in 2007, Divided We Fail has organized nearly 1,000 local events including 500 “Community Conversations” to inform Americans about the options to address health care and financial security and gather new ideas from the public. Volunteers in their red Divided We Fail shirts became a fixture on the campaign trail, showing their support from the first stops in Iowa to Election Day.
Today’s event launches the group’s 2009 mobilization and education activities, which include town hall meetings over the first Congressional recess to help constituents connect with their lawmakers and discuss how the health care and economic crises are affecting them.
“Partisan gridlock won’t do anything to end the health and economic problems our country faces,” said Todd Stottlemyer, President and CEO of NFIB. “If our organizations-business, labor and consumers-can join forces, so can our leaders in Washington. We’re just getting started and we’re ready to help.”
“If there’s one thing we’ve known these past two years-made painfully clear to all of us in the past few months-is that there can be no economic security without health care security,” said Business Roundtable President John Castellani. “Our CEOs stand ready to work with the president-elect and the new Congress to bring about important legislation to provide real security to the American people.”
“Our broken health care system has a stranglehold on any chance for economic recovery that can last,” said Andy Stern, President of SEIU, the nation’s largest union of healthcare workers. “It’s clear that to solve America’s healthcare crisis, all of us-individuals, corporate leaders, healthcare providers and the government-must come together to find solutions that work.”
Divided We Fail’s supporters include more than 360 members of the 111th Congress who have signed the pledge or written a letter of support. In additional to AARP, Business Roundtable, NFIB and SEIU, more than 100 independent groups have pledged their support. To learn more and sign the pledge, visit http://www.DividedWeFail.org.
Divided We Fail
It’s time we ensure health and long-term financial security for all. That’s why AARP, Business Roundtable, the Service Employees International Union and the National Federation of Independent Business, are leading Divided We Fail, an initiative to give voice to millions of Americans who are tired of letting Washington gridlock stand in the way of affordable, quality health care and long-term financial security – the most pressing domestic issues faction our nation. Common sense solutions are needed, and everyone – individuals, businesses and government – has a role and a responsibility in ensuring health and financial security for all. Go to http://www.DividedWeFail.org to learn more.
Divided We Fail
New Phase Of National Hepatitis C Awareness Campaign Launched For GPs, UK
The Department of Health is gearing up to launch a hepatitis C public health campaign to improve detection and diagnosis among the 100,000 people in England who are thought to be unaware they have the infection.
The campaign will get underway at the start of next month with radio and press advertising to remind the public of life experiences that could have exposed them to infection.
GPs will be encouraged to support the campaign by offering information and testing for patients in at risk groups.
The campaign coincides with the 20th anniversary of the virus being identified and follows a recent letter from the Chief Medical Officer and Chief Nursing Officers to Primary Care Trusts on improving the detection and diagnosis of hepatitis C in primary care.
Many people who have hepatitis C do not show symptoms for many years and may have normal liver function tests. Over time, hepatitis C can cause serious liver damage (cirrhosis, primary liver cancer or liver failure), which can be prevented by effective drug therapy.
The Department is calling on GPs to be extra vigilant and consider testing for the virus in patients in at risk groups such as those who may have injected drugs in the past, even if only once or twice or a long time ago, or those who may have had a tattoo or piercing with unsterile equipment.
In the lead up to the campaign, a number of information resources are being made available for health professionals, including on NHS Choices, a quick reference guide for primary care and a new patient information leaflet.
Professor Steve Field, Chairman of the Royal College of General Practitioners said: “We are pleased to see the launch of a new phase of the Department of Health’s campaign to raise awareness of hepatitis C amongst GPs and the public. GPs play an important role in detection and diagnosis of hepatitis C and we want this to continue. It is important to make sure that healthcare professionals are aware of the transmission routes, and diagnosis and treatment of the virus, so that patients at risk are identified at the earliest possible opportunity and can be treated effectively.”
- The Department of Health’s hepatitis C awareness campaign aims to raise awareness of the virus, which was first identified in 1989, and improve its prevention, diagnosis and treatment, while tackling the stigma often attached to it.
- Hepatitis C is a blood-borne virus that causes chronic infection that can lead to serious liver damage (cirrhosis and primary liver cancer). It is recognised as a significant public health problem worldwide. In England, it is estimated that there are approximately 100,000 people with chronic hepatitis C infection and that about half of these are probably unaware of their infection.
- There is currently no vaccine against hepatitis C, so prevention of new infections is particularly important. There is effective antiviral drug treatment, which has been approved by the National Institute for Clinical Excellence (NICE). Lifestyle changes, in particular decreasing alcohol intake, can delay the onset of liver disease.
- The Department of Health’s hepatitis C awareness campaign supports the Hepatitis C Action Plan for England, which seek to improve the prevention, diagnosis and treatment of hepatitis C. The Action Plan is available on the DH website at: http://www.dh.gov.uk/publications.
- GPs and other health professionals are being alerted to the campaign in advance of a public launch at the end of January. Formerly called ‘Face It’, the new campaign will place a greater focus on targeting high risk groups, such as former intravenous drug users, and will include press and radio advertising and news and features in the media. A specific arm of the campaign will also target South Asians following emerging evidence that some of these communities in England may be at increased risk of infection.
- The advertising campaign, which focuses on the theme ‘Have you ever?’, poses a series of questions to the public, encouraging them to think about life experiences which may have exposed them to hepatitis C infection. Examples of these life experiences will also be profiled in a number of short film clips for the public about the issues surrounding hepatitis C, including interviews with patients, GPs and other healthcare professionals. These will be available from February on the NHS Choices website (http://www.nhs.uk/hepc).
- Free hepatitis C information resources such as Hepatitis C: quick reference guide for primary care and patient leaflets are available at http://www.orderline.dh.gov.uk or http://www.nhs.uk/hepc.
http://www.dh.gov.uk
Drug Abusing Offenders Not Getting Treatment They Need In Criminal Justice System, USA
The vast majority of prisoners who could benefit from drug abuse treatment do not receive it, despite two decades of research that demonstrate its effectiveness, according to researchers at the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. In a report published in the Journal of the American Medical Association, NIDA scientists note that about half of all prisoners (including some sentenced for non-drug-related offenses) are dependent on drugs, yet less than 20 percent of inmates suffering from drug abuse or dependence receive formal treatment.
“Treating drug-abusing offenders improves public health and safety,” said NIDA Director and report coauthor Dr. Nora D. Volkow. “In addition to the devastating social consequences for individuals and their families, drug abuse exacts serious health effects, including increased risk for infectious diseases such as HIV and hepatitis C; and treatment for addiction can help prevent their spread.Providing drug abusers with treatment also makes it less likely that these abusers will return to the criminal justice system.”
The authors of the report suggest that the criminal justice system is in a unique position to encourage drug abusers to enter and remain in treatment, thereby disrupting the vicious cycle of drug use and crime. In fact, most studies indicate that outcomes for those who are legally pressured to enter treatment are as good as or better than outcomes for those who enter treatment without legal pressure, the researchers note.
“Addiction is a stigmatized disease that the criminal justice system often fails to view as a medical condition; as a consequence, its treatment is not as available as it is for other medical conditions,” stated Dr. Redonna K. Chandler, the report’s principal author and chief of NIDA’s Services Research Branch.
There are several ways in which drug abuse treatment can be incorporated into the criminal justice system. These include therapeutic alternatives to incarceration, treatment merged with judicial oversight in drug courts, treatments provided in prison and jail, and reentry programs to help offenders transition from incarceration back into the community.
Some communities cite costs as the reason for not treating drug-involved offenders; however, the report discusses the economic benefits of treating such offenders. “A dollar spent on drug courts saves about $4 in avoided costs of incarceration and health care; and prison-based treatment saves between $2 and $6,” Chandler said.
The report emphasizes that addiction is a chronic brain disease: that repeated drug exposure in those who are vulnerable triggers brain changes that result in the compulsive drug use and loss of control over drug-related behaviors that characterize addiction. “Viewing addiction as a disease does not remove the responsibility of the individual,” said Volkow. “It highlights the responsibility of the addicted person to get drug treatment and society’s responsibility to make treatment available.”
To learn more about the latest research on treatment for drug abusers in the criminal justice system, download NIDA’s Principles of Drug Abuse Treatment for Criminal Justice Populations at http://www.drugabuse.gov/PODAT_CJ/principles.
The National Institute on Drug Abuse is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world’s research on the health aspects of drug abuse and addiction. The Institute carries out a large variety of programs to inform policy and improve practice. Fact sheets on the health effects of drugs of abuse and information on NIDA research and other activities can be found on the NIDA home page at http://www.drugabuse.gov.
The National Institutes of Health (NIH) – The Nation’s Medical Research Agency – includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
The National Institutes of Health
RAD001 Phase II Trial Results Positive In Patients With Advanced Gastric Cancer After Failure Of One Or More Prior Treatments
Data released show RAD001 (also known as everolimus; proposed brand name Afinitor(R)) halted tumor growth in 55% of patients with advanced gastric cancer, a condition for which there are limited treatment options. In addition, 45% of patients in the study demonstrated some tumor shrinkage(1).
The data will be presented at the American Society of Clinical Oncology’s 2009 Gastrointestinal Cancers Symposium on January 15.
The open label, single arm, multi-center Phase II study of 54 patients conducted in Japan, is designed to assess the efficacy and safety of RAD001 in patients with advanced gastric cancer whose disease progressed despite prior treatment. Patients enrolled in the trial were heavily pre-treated. All trial participants were from Japan and of Asian descent (1).
“There are very limited treatment options for patients who progressed despite the standard treatment for this aggressive cancer,” said Atsushi Ohtsu, MD, PhD, Director, Research Center for Innovative Oncology, National Cancer Center Hospital East, Chiba, Japan. “The results from this study demonstrate that RAD001 has the potential to provide an effective new option for these patients.”
A global Phase III clinical trial program to evaluate the efficacy and safety of RAD001 monotherapy in approximately 500 advanced gastric cancer patients will begin enrollment this year.
“Most advanced gastric cancer patients eventually stop responding to current therapies, demonstrating a considerable need for new treatment options,” said Alessandro Riva, MD, Executive Vice President & Global Head of Development, Novartis Oncology. “Early data show RAD001 may benefit these patients and provides the rationale for additional studies. Novartis is committed to further exploring the potential of RAD001 for this hard to treat cancer, as well as studying its role in treating other tumor types.”
Gastric cancer, commonly referred to as stomach cancer, was diagnosed in 21,500 Americans in 2008 and claimed the lives of more than 10,000 in the same time period(2). This cancer is highly prevalent among people of Asian descent, with more than half of all new cases occurring in East Asia(3). It is believed that the incidence is high among this population due in part to Helicobacter pylori infection and a diet high in smoked, salted or pickled foods. Among ethnicities in the US, Asians and Pacific Islanders have the highest mortality rates(4).
Study details
The proof-of-concept, Phase II study is designed to assess the efficacy and safety of RAD001 (10 mg) daily in patients with advanced gastric cancer (inoperable, recurrent or metastatic gastric cancer) whose disease progressed despite prior treatment. The primary endpoint of the study is to assess disease control rate (DCR). Secondary endpoints included assessment of objective response rate (ORR), progression-free survival (PFS) and overall survival (OS), and to describe the safety profile of RAD001.
The average duration of therapy was 57 days. There was a DCR (complete response/partial response/stable disease) of 55% at eight weeks (95% Confidence Interval: 40.4 – 68.4%). Of the 53 patients evaluated for the study’s primary endpoint, 29 patients (55%) had stable disease, 22 (41%) had progressive disease and 2 (4%) had an unknown response. The ORR was zero. The median PFS was 83 days (95% Confidence Interval: 50 – 91 days), with 29.6% of patients estimated to still be progression-free at four months. Median overall survival was not attained at the time of evaluation.
The most commonly reported adverse events (all grades; >10% patients) in the study included, stomatitis, anorexia, fatigue, rash, nausea, edema peripheral, thrombocytopenia, diarrhea, pruritus, anemia, dysgeusia, vomiting, pyrexia, pneumonitis, constipation and insomnia. Serious adverse events (grade 3 or 4; >3% of patients) included anemia, hyponatremia, raised liver function, fatigue, stomatitis, anorexia, hyperglycemia, hypophosphatemia, ileus and lymphopenia.
About RAD001
RAD001, an oral once-daily inhibitor of mTOR, is an investigational drug being studied in multiple tumor types. In cancer cells, RAD001 provides daily inhibition of mTOR, a protein that acts as a central regulator of tumor cell division, cell metabolism and blood vessel growth.
RAD001 is being studied in multiple cancer types including advanced kidney, breast and neuroendocrine tumors and lymphoma. Currently, RAD001 is under regulatory review in the US and Europe for the treatment of advanced renal cell carcinoma.
The safety and efficacy profile of RAD001 has not yet been established in oncology and there is no guarantee that RAD001 will become commercially available for oncology indications. The active ingredient in RAD001 is everolimus, which is available in different dosage strengths under the trade name Certican(R) for the prevention of organ rejection in heart and kidney transplant recipients. Certican was first approved in the EU in 2003. Certican is not approved in the US.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “promising,” “will,” “potential,” “may,” “committed,” “exploring,” “believed,” “estimated,” “anticipated,” or similar expressions, or by express or implied discussions regarding potential regulatory filings or marketing approvals for RAD001 or regarding potential future revenues from RAD001. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with RAD001 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that RAD001 will be approved for sale for any oncology indication in any market. Nor can there be any guarantee that RAD001 will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding RAD001 could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company’s mission is to improve people’s lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs, innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
References
(1) Ohtsu, A et al. Multicenter phase II study of RAD001 for previously treated metastatic gastric cancer. Presented at the American Society of Clinical Oncology’s 2009 Gastrointestinal Cancers Symposium, January 15, 2008.
(2) American Cancer Society. Detailed Guide: Stomach Cancer. Available at : http://www.cancer.org/docroot/CRI/content
(3) Ohtsu, A. Chemotherapy for metastatic gastric cancer: past, present, and future. J Gastroenterol 2008; 43:256-264.
(4) American Cancer Society. Overview: Stomach Cancer.
Novartis Pharmaceuticals Corporation
http://www.novartis.com
MicroPhage Successfully Completes Beta Trial For Rapid MRSA Test
A new bacterial identification test that rapidly identifies MRSA infections moved closer to market with conclusion of its first multicenter clinical trial, which was announced by MicroPhage, Inc., http://www.microphage.com. The company also reported the trial results have surpassed its early-stage performance expectations.
The beta-site study evaluated MicroPhage’s prototype assay to identify Staphylococcus aureus (staph) bacteria and determine methicillin resistance (MRSA) or susceptibility (MSSA) in suspected cases of bacteremia (bacteria in the blood). The research precedes FDA-submission clinical studies, which are scheduled to begin early this year. Beta sites included Johns Hopkins University, Northshore University Healthcare (IL.), and the University of Maryland Medical School. More information on the study is available on the National Institute of Health’s ClinicalTrials.gov website, study # NCT00814151.
According to Drew Smith, Ph.D, Director, Research and Development at MicroPhage, test performance at the three sites exceeded all study goals and performed at or near FDA requirements in more than 700 clinical samples. “Our prototype assay performed like a market-ready test for identification of MRSA, producing excellent results with regard to specificity,” said Smith. “We are confident the final manufactured product will be robust and meet the demands of the clinical laboratory market and the scrutiny of the FDA.” He added that the system is expected to be available to US hospitals later this year.
The field trials confirm previous performance studies reported in October at the prestigious joint meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and Infectious Disease Society of America. That research showed the MicroPhage system provides results in five hours versus up to 48 hours for culture testing methods, and had an excellent detection rate for S. aureus bacteria of 93 percent while also determining methicillin resistance or susceptibility at greater than 98 percent reliability. Results of the beta trial were not available for release, pending final analysis and publication.
The MicroPhage system requires no instrumentation and is composed of two small reaction tubes for incubating blood-culture specimens. After five hours, the incubated samples are added to two dipstick-like detectors. One detector shows if the sample is infected with staph bacteria and the other measures antibiotic susceptibility/resistance.
MicroPhage has adapted bacteriophage-amplification technology, a natural biologic process, for identifying bacterial infections. “Phages” are bacteria-specific viruses that multiply aggressively when exposed to target bacteria. In the detection process, reaction of the bacteriophage proteins on the test strip indicates the sample is positive for staph bacteria. For susceptibility analysis, the organism in the sample is challenged with an antibiotic. Because phages depend on host bacteria for growth, any compound that kills or inhibits the microbe will stop phage growth. Only resistant strains allow multiplication of phages and yield a positive signal on the detector strip. Further information about the technology is available at http://www.microphage.com/technology.
About MicroPhage
Based in Longmont, Colo. and privately held, MicroPhage, Inc. is working to be a global leader in developing rapid diagnostics products for bacterial identification and antibiotic susceptibility/resistance testing. Using its proprietary bacteriophage-based amplification platform, the company has developed a patented process that is a product platform or engine for rapid, easy-to-use, inexpensive diagnostic tests. Its first products, expected in late 2009, will set a new standard for clinicians in MRSA identification and antibiotic susceptibility testing, and are designed to fit the demands of hospitals and laboratories of all sizes. For further information, go to http://www.microphage.com.
MicroPhage, Inc.
http://www.microphage.com
Walking On A Treadmill Helped PAD Patients
A new study from the US found that patients with peripheral arterial disease (PAD), which is sometimes accompanied by pain in leg muscles,
improved their walking endurance and quality of life by taking part in a treadmill walking exercise that also helped patients who did not have the
classic symptoms of pain in the legs.
The study was the work of Dr Mary M McDermott, of the Northwestern University Feinberg School of Medicine in Chicago, and colleagues, and is
published in the 14 January issue of the Journal of the American Medical Association, JAMA.
PAD in the lower extremities is where the arteries that delivery blood to the legs are partially or completely blocked because of plaque build-up. The
condition affects about 1 in 16 adults aged 40 and over in the US. People with PAD are less able to do everyday things and decline more rapidly than
the general population, said the authors in their background information.
For some patients, PAD occurs with intermittent claudication (pain in the leg muscles that comes and goes), but according to the authors it is usually
the patients without these symptoms that have greater functional impairment and decline.
McDermott and colleagues wanted to find out if it was possible for PAD patients with and without leg pain to improve functional performance and
other factors, by undergoing supervised treadmill exercise and lower extremity-resistance training.
For the randomized controlled clinical trial, which took place from 2004 to 2008, the researchers recruited 156 patients with PAD and randomly
assigned them to a supervised treadmill exercise group, a lower extremity resistance (strength) training group, or a control group, for six
months.
Before and after the trial the patients underwent physical performance assessments and filled in questionnaires. They also had their blood flow
measured, which involved stopping exercise and medications and fasting for 12 hours beforehand. The examiners did not know which group the
patients they examined were in.
The primary outcome measures were two physical performance tests: one was a 6-minute walk up and down a corridor, and the other was a short
battery of physical performance tests to measure leg strength and balance.
The results showed that after six months:
- In the 6-minute walking performance test, the treadmill group increased their walking distance by an average of 69 feet (20.9 m), whereas the
control group’s walking distance went down by an average of 49 feet (15.0 m), for a mean difference of 118 feet (35.9 m) between the two
groups.
- The lower extremity resistance training group did not show a change in their 6-minute walking performance compared to the control
group.
- There were no differences in change in scores on the short physical performance battery test between the treadmill exercise and control groups, or
between the lower extremity resistance training and control groups.
- Participants in the treadmill exercise group had better improvements in brachial arterial flow-mediated dilation compared to the control group,
but the changes in this measure for the lower extremity resistance training group were no different than those of the control group.
- Both exercise groups showed significantly greater increases in average maximum treadmill walking than the control group.
- The treadmill exercise group showed significantly bigger average improvement in their physical functioning score (using the Medical Outcomes
Study Short-Form 36 or SF-36) and their walking impairment distance compared with the control group.
- The lower extremity resistance training group also showed a bigger average improvement in these two scores, and also in stair climbing tests, compared to the control group.
The authors concluded that:
“Supervised treadmill training improved 6-minute walk performance, treadmill walking performance, brachial artery flow-mediated dilation, and
quality of life but did not improve the short physical performance battery scores of PAD participants with and without intermittent claudication [leg
pain].”
“Lower extremity resistance training improved functional performance measured by treadmill walking, quality of life, and stair climbing ability,” they
added, suggesting that:
“Based on findings reported in this trial, physicians should recommend supervised treadmill exercise programs for PAD patients, regardless of whether
they have classic symptoms of intermittent claudication.”
“Treadmill Exercise and Resistance Training in Patients With Peripheral Arterial Disease With and Without Intermittent Claudication: A
Randomized Controlled Trial.”
Mary M. McDermott; Philip Ades; Jack M. Guralnik; Alan Dyer; Luigi Ferrucci; Kiang Liu; Miriam Nelson; Donald Lloyd-Jones; Linda Van Horn;
Daniel Garside; Melina Kibbe; Kathryn Domanchuk; James H. Stein; Yihua Liao; Huimin Tao; David Green; William H. Pearce; Joseph R. Schneider;
David McPherson; Susan T. Laing; Walter J. McCarthy; Adhir Shroff; Michael H. Criqui.
JAMA Vol. 301 No. 2, pp 165-174, January 14, 2009
Click here for Article.
Sources: Journal article, JAMA press release.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Evolution Of New Brain Area Enables Complex Movements, Pitt Study Shows
A new area of the cerebral cortex has evolved to enable man and higher primates to pick up small objects and deftly use tools, according to neuroscientists at the University of Pittsburgh School of Medicine and Pittsburgh’s Veterans Affairs Medical Center.
The brain’s primary motor cortex turns out to have neighboring “old” and “new” parts. In most animals, including cats, rats and some monkeys, the old primary motor cortex controls movement indirectly through the circuitry of the spinal cord, explained senior author Peter Strick, Ph.D., professor in the department of neurobiology at the School of Medicine and senior career scientist at the VA Medical Center.
But in man, the Great Apes and some monkeys, another area of the motor cortex developed and is now home to a special set of cortico-motoneuronal (CM) cells, he said. These cells directly control spinal cord motor neurons, which are the nerve cells responsible for causing contraction of shoulder, elbow and finger muscles. The direct control exerted by CM cells bypasses the limitations imposed by spinal cord circuitry and permits the development of highly complex patterns of movement, such as the independent finger action needed for playing an instrument or typing.
“What we’ve shown is that along with evolution of direct control over motor neurons, a new cortical area has evolved that’s right next to the old one,” Dr. Strick said. “We still have much the same spinal machinery the frog has, but the new cortical area with CM cells endows humans with the superior hand skills to manufacture and use tools – an especially human trait.”
He and co-author Jean-Alban Rathelot, Ph.D., a research associate in Dr. Strick’s lab, based their conclusions on a series of experiments in which rabies virus was injected into single muscles in the shoulders, elbows or fingers of monkeys. The virus, chosen because of its unique ability to travel between networked nerve cells, was tracked to locate CM cells in the primary motor cortex. The findings have been published in the early online edition of the Proceedings of the National Academy of Sciences.
Dr. Strick noted that the direct connection from the cortex to motor neurons is not present at birth, but develops during the first few months of life and becomes fully mature around two years of age. Thus, the progress of an infant’s motor skills is a display of the establishment of these connections.
The research was funded by grants from the Department of Veterans Affairs, the National Institutes of Health and the Pennsylvania Department of Health.
The University of Pittsburgh School of Medicine is one of the nation’s leading medical schools, renowned for its curriculum that emphasizes both the science and humanity of medicine and its remarkable growth in National Institutes of Health (NIH) grant support, which has more than doubled since 1998. For fiscal year 2006, the University ranked sixth out of more than 3,000 entities receiving NIH support with respect to the research grants awarded to its faculty. As one of the university’s six Schools of the Health Sciences, the School of Medicine is the academic partner to the University of Pittsburgh Medical Center. Their combined mission is to train tomorrow’s health care specialists and biomedical scientists, engage in groundbreaking research that will advance understanding of the causes and treatments of disease and participate in the delivery of outstanding patient care.
University of Pittsburgh School of Medicine
