Mayo Clinic has announced a five-year, $5 million donation to The Hormel Foundation for The Hormel Institute Medical Research Center. The funds will help equip laboratories in the institute's new research facility and provide program support to researchers from The Hormel Institute, Mayo Clinic and the University of Minnesota.
Established in 1942, The Hormel Institute is a research unit of the University of Minnesota. The institute conducts biomedical research in partnership with researchers located around the world. Much of this research focuses on finding natural, nontoxic alternatives to chemotherapy. Since 2002, The Hormel Institute's funding from the National Institutes of Health has tripled and its staff has nearly doubled under the leadership of executive director Zigang Dong, M.D. A $23.4 million expansion project is underway that will triple the facility's size.
Glenn Forbes, M.D., chief executive officer (CEO) of Mayo Clinic Rochester says, "Nothing is more important than providing the best care to our patients. Collaborations, like this between The Hormel Institute, Mayo Clinic and University of Minnesota, will enable us to make discoveries much more quickly. Mayo's commitment to research extends beyond our campuses, and we're especially interested in the cancer research conducted by Dr. Dong and his team. We hope this gift will help provide the resources necessary so that The Hormel Institute will continue to thrive."
Richard Knowlton, chair of The Hormel Foundation and former president, CEO and chair of the board of Hormel Foods Corporation says, "The vision of Mayo Clinic to accelerate medical research through their financial and collaborative support is the same vision that has made Mayo a world leader in medicine and health care. This gift supports the world-class medical research of The Hormel Institute well into the future. We are thankful for the growing research partnership with Mayo Clinic and the vision we share to improve the health of our country and the world."
"The progress of medical research that is occurring and will occur because of the strengthening collaboration between The Hormel Institute and Mayo Clinic is significant," says Dr. Dong. "We are deeply thankful to Mayo Clinic for this historic gift to The Hormel Foundation on our behalf, a gift that is a first in Mayo Clinic's history. This financial support shows their dedication to our research partnership."
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Sunday, September 7, 2008
Mayo Clinic Gives $5 Million Donation to The Hormel Institute
Sarah Cannon Research Institute Presents New Findings in Breast Cancer Treatment
BUSINESS WIRE --Sarah Cannon Research Institute (SCRI) investigators have found that “smart bomb” therapies are effective in treating breast cancer patients while minimizing side effects.
Howard A. Burris III, M.D., SCRI’s chief medical officer, presented interim Phase II clinical trial results of a drug named Trastuzumab-DM1 (T-DM1), a novel antibody drug conjugate, on September 5th at the American Society of Clinical Oncology’s Breast Cancer Symposium in Washington, D.C.
T-DM1 is built from the widely used antibody Herceptin. T-DM1 combines Herceptin’s HER2 blocking activity with a targeted intracellular delivery of a potent anti-microtubule agent directly into HER2-positive breast cancer cells. In 20 percent of breast cancer cases, the patient’s cancer has too much of the HER2 protein, which makes the cancer cells grow and divide more quickly. T-DM1 is designed to focus delivery of treatment to HER2-positive cancer cells and limit delivery to surrounding healthy tissue.
Dr. Burris and his team were the first oncologists to treat patients with T-DM1 in December 2006. Minimal toxicities have been observed in the trial to date.
“Physicians call it a ‘smart bomb’ because it’s designed to hit the target cancerous cells with minimal collateral damage to its neighboring non-cancerous cells,” Dr. Burris said.
Thirty-one patients with HER2-positive metastatic breast cancer whose tumors had progressed on prior HER2-directed therapy in the trial received 3.6 mg/kg of T-DM1 by IV every three weeks. The interim findings of the Phase II study include evidence of tumor shrinkage in some patients.
Murfreesboro, Tenn. resident Nancy Fann, 64, had been on at least three chemotherapy treatments since cancer had spread from her lung to her liver and breast, but the tumors kept coming back. In May 2007 she enrolled in the T-DM1 clinical trial.
“The tumors are considerably smaller than they were to begin with,” Fann said. “This drug doesn’t seem to affect me as much as some of the others I’ve been on. I don’t get sick and I haven’t lost my hair.”
Denise A. Yardley, M.D., SCRI’s director of breast cancer research, also presented her research on two trials. Both trials focus on targeted therapies for patients with HER2-positive metastatic breast cancer.
One trial shows preliminary results from a Phase II trial of a combination of Herceptin and the chemotherapy drug oxaliplatin. Twenty-one patients have enrolled in the trial so far, and early results show the treatment is active with little to no significant side effects seen to date.
The other trial focuses on a combination treatment of Avastin and the chemotherapy drug docetaxel for early-stage, metastatic breast cancer. A cohort of patients with HER2-positive disease also receives Herceptin as part of the study. Data for the first 138 patients enrolled indicate the treatment is reasonably well-tolerated without unexpected side effects.
“As knowledge about tumors and tumor biology grows, we’re learning that all breast cancers are not identical,” Dr. Yardley said. “These smart new drugs help target treatment specific to certain types of tumors, causing less damage to healthy cells and reducing side effects.”
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Saturday, September 6, 2008
Hopkins Experts: Most Vaccine-Allergic Children Can Still Be Safely Vaccinated
With close monitoring and a few standard precautions, nearly all children with known or suspected vaccine allergies can be safely immunized, according to a team of vaccine safety experts led by the Johns Hopkins Children’s Center. Writing in the September issue of Pediatrics, the multicenter research team offers pediatricians a step-by-step tool for quickly identifying children with allergic reactions to vaccines, and a much-needed guide, they say, to safely immunize those who are allergic.
Serious allergic reactions to vaccines are extremely rare — one or two per million vaccinations, according to some estimates — but when they happen, such episodes can be serious, even life-threatening, making it critical for pediatricians to instantly spot true allergic reactions and differentiate them from more benign nonallergic responses, investigators say. It is also crucial that pediatricians design a safe immunization plan for children with confirmed vaccine allergies. Children who have had one allergic reaction are believed to be at a higher risk for future reactions, typically more serious than the first.
“We cannot reiterate enough that the vaccines used today are extremely safe, but in a handful of children certain vaccine ingredients can trigger serious allergic reactions,” says Robert Wood, M.D., lead author on the paper and chief of pediatric Allergy and Immunology at Hopkins Children’s. “For the most part, even children with known allergies can be safely vaccinated.”
Given recent outbreaks of vaccine-preventable infections like measles, mumps and whooping cough in the United States, and measles and polio overseas, it is essential to safely vaccinate as many children as possible, investigators say.
Combing through available evidence on vaccine safety and allergies, the Hopkins-led team developed a sequence of instructions – an algorithm – that prompts physicians one step at a time on how to evaluate and immunize children with known or suspected vaccine allergies.
The guidelines are intended for doctors and parents who are uncertain about vaccine safety in children who have already had or are at high risk for having allergic reactions to vaccines.
In such cases, the Hopkins-led group advises a workup by an allergist, including skin prick testing—a prick on the skin or an injection under the skin with a small dose of vaccine or the suspected allergen from the vaccine—or blood tests that would detect the presence of characteristic antibodies that patients develop to allergens, such as antibodies to gelatin or egg proteins used in several common vaccines.
In many cases, allergic children can be vaccinated using alternative forms of a vaccine that are free of the allergen. Even if allergen-free formulations are unavailable, many children can still be vaccinated and remain under physician supervision for several hours after vaccination. Another option is testing the child to check for immunity. If blood tests show the child has already developed protective antibodies, it may be OK, at least temporarily, to withhold further doses of the vaccine, researchers write.
“Vaccines save lives, and parents should know that children who have had allergic reactions after a vaccine are likely to have developed protection against infection as a result of the vaccination,” says investigator Neal Halsey, M.D., an infectious disease specialist at Hopkins Children’s, and professor of International Health at the Johns Hopkins University Bloomberg School of Public Health.
“Most children who have had an allergic reaction after a vaccine can still be vaccinated against other diseases safely and some can receive additional doses of vaccines they might have reacted to,” Halsey adds.
Many children with known vaccine allergies who have low levels of protective antibodies and require more doses can be vaccinated safely under the guidelines. In some cases, children with known allergies can be given antiallergy medications, such as antihistamines and corticosteroids, before vaccination to help ward off or lessen the allergic reaction. For a step-by-step guide to vaccine administration in children with known or suspected vaccine allergy, see the full text of the article at http://pediatrics.aappublications.org/future/122.3.shtml.
Immunizations of children with known vaccine allergies should always be administered under medical supervision in a clinic equipped to treat life-threatening allergic reactions or in a hospital intensive-care unit. Patients can usually go home after an hour or two if they have no adverse reactions.
True allergies typically cause immediate reactions, involving the immune system as a whole that occur within a few minutes to a few hours of vaccination. By contrast, delayed reactions, which occur within days, even weeks after vaccination, are generally benign and are rarely, if ever, dangerous.
Symptoms of immediate allergic reactions include hives, swelling, wheezing, coughing, low blood pressure, vomiting, diarrhea, and can lead to full-blown anaphylaxis, a life-threatening allergic reaction.
The research was funded by the Centers for Disease Control and Prevention.
Co-investigators on the research: Melvin Berger, M.D. Ph.D., University Hospitals of Cleveland; Stephen Dreskin, M.D. Ph.D., University of Colorado; Rosanna Setse, M.D. M.P.H., Johns Hopkins University Bloomberg School of Public Health; Renata Engler, M.D., Walter Reed Army Medical Institute; Cornelia Dekker, M.D., Stanford University School of Medicine. The Clinical Immunization Safety Assessment Network, consisting of six medical research centers with expertise in immunization safety, was part of the study.
Conflict of interest disclosure for Hopkins investigators: Halsey has received research support from vaccine manufacturer Wyeth and is a consultant for vaccine manufacturers GlaxoSmithKline and Merck.
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Friday, September 5, 2008
Emory Announces Opening of Emory University Orthopaedics & Spine Hospital
Fulfilling its mission to meet the increasing demand for orthopaedics and spine care, Emory Healthcare today announced the opening of the Emory University Orthopaedics & Spine Hospital. The hospital, an extension of Emory's acute care hospital on Clifton Road, will open Tuesday, Sept. 16.
Located at the intersection of Lawrenceville Highway and I-285 in Tucker, Emory University Orthopaedics & Spine Hospital was created to provide high-quality care in the delivery of general acute care services while primarily focused on a specific service line. Emory purchased an existing hospital facility in January 2007, and has now completely renovated it to provide patients with access to the most advanced, sophisticated technology in a patient-and-family friendly environment.
"Emory continues to uphold a promise and commitment to our patients -- to provide a quality experience defined by impeccable clinical outcomes, patient safety and patient service," says Fred Sanfilippo, MD, PhD, executive vice president for health affairs at Emory University and chairman of Emory Healthcare.
"This hospital will combine exceptional service with pioneering vision, education, teaching and ideas, and Emory will apply its strategic vision to ensure that we are serving the needs of our patients and their families. This new facility underscores that commitment and vision."
In addition, Emory University Orthopaedics & Spine Hospital is implementing an innovative nursing model where caregivers partner with patients and their families to collaborate on decisions and care. By primarily concentrating orthopaedic surgical services at one location, Emory physicians and staff will be able to focus on the unique needs of the orthopaedic patient population, which translates to quick recovery times, increased safety and greater patient satisfaction.
"The creation and opening of Emory University Orthopaedics & Spine Hospital is an important achievement for Emory Healthcare on behalf of the communities and patients we serve," says John T. Fox, CEO of Emory Healthcare. "Starting from a blank sheet of paper and seeking patient input, we were able to establish a clear vision of the best structure and culture for the new facility, and we worked tirelessly to bring our patients the care they deserve.
"Additionally, and perhaps even more exciting, Emory University Orthopedics & Spine Hospital will embody the collaborative and innovative culture-of-care elements that will help set the future course of patient care across the country, including patient-and family-centered care, shared decision making, a fair and just culture, transparency, and cultural competency and diversity," says Fox. "These attributes are embedded in our decision-making process and, more importantly, are evident in our provision of care."
In addition to offering orthopaedics and spine services in a focused capacity, Emory University Orthopaedics and Spine Hospital will also continue to offer general acute care services for patients with non-surgical needs. A team of Emory University Hospital-based physicians will treat a wide variety of non-critical patient medical conditions, while providing a seamless link to all other specialists located at other Emory hospitals.
"This innovative combination gives patients the benefits of a higher level of care with all the attributes of a major university medical center - research, technology and sub-specialists," says Scott Boden, MD, professor of orthopaedic surgery and director of the Emory Orthopaedics & Spine Center.
"This type of facility is proven to have better outcomes because all physicians and staff are focused on one type of patient problem," says Boden. "By concentrating the orthopaedic surgical services at this location, we will gain a special opportunity to create standardized processes whereby all our physicians and staff are focused on the unique needs of the orthopaedic and spine surgery patient population."
Dr. James R. Roberson, chair of the Department of Orthopaedics and professor of orthopaedic surgery, Emory University School of Medicine, says, "The carefully selected faculty members of Emory's Department of Orthopaedics are some of the most talented and skilled medical professionals in the country and around the globe. These specialists work in tandem with physicians throughout Emory's network to collaborate on diagnosis and treatment of our patients, as well as mentor future orthopaedists and orthopaedic surgeons."
Facts about Emory University Orthopaedics & Spine Hospital and Emory Orthopaedics & Spine Center
Hospital: The Emory University Orthopaedics & Spine Hospital, an extension of Emory University Hospital, is staffed exclusively by Emory physicians. The facility is six stories and has 208,000 square feet of space which includes a medical office building.
It provides complete MRI and radiology capabilities as well as on-site inpatient and outpatient physical therapy. Furnishings and furniture in the new facility are customized for total joint and spine patients, and there are newly appointed private suites (most private suites have a pullout bed for family members).
The facility has a dedicated orthopaedics and spine patient floor, as well as general medicine services. Because there is unrestricted visiting hours, families can stay with patients all of the time. A restaurant and in-room dining are available 7 am-7 pm.
There will be no emergency room located at Emory University Orthopaedics & Spine Hospital. All emergency and trauma traffic will be diverted to the nearest appropriate facility.
Outpatient Center: The Emory Orthopaedics & Spine Center is a state-of-the-art outpatient facility located at Executive Park, which offers a comprehensive approach to all musculoskeletal problems. The Center has reinvented orthopaedic and spine care by bringing all aspects of diagnosis, treatment and rehabilitation together in one location.
More than 40 specialists work together under one roof [95,000 square feet] to provide the full range of outpatient orthopaedic, spine, neurosurgery, sports medicine and physical therapy care. The Center at Executive Park is about 7 miles from Emory University Orthopaedics & Spine Hospital.
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Prescription Drug Advertising Subject of New FDA Web Site for Consumers
PRNewswire/ -- EthicAd, a nonprofit organization devoted to improving public health through consumer education, announces the launch of a new FDA Web site created to help the general public better understand direct-to-consumer (DTC) advertising of prescription medications. The site, "Be Smart About Prescription Drug Advertising," is hosted by the FDA's Center for Drug Evaluation and Research and was developed by the FDA in partnership with EthicAd. For details, visit www.FDA.gov/CDER/ethicad/index.htm or link to the site via FDA's homepage, www.fda.gov.
Michael S. Shaw, M.D., executive director of EthicAd, notes that the primary goal of the new site is to help the public obtain accurate, science-based information about prescription drugs and to understand the role and nature of DTC advertising.
"People are often confused about DTC advertising, which is one of the most controversial areas of pharmaceutical marketing," Shaw says. "FDA's new Web site helps clarify the issues by outlining the different types of DTC advertising, explaining what information people should expect to see in DTC ads, and what additional information they should seek out about advertised products."
The easy-to-navigate site includes a practical "Ask Yourself" checklist summarizing information consumers should obtain in order to have knowledgeable conversations with their physicians about advertised products. The new Web site also includes a section for public feedback, which will be used to shape the direction of future FDA consumer-oriented initiatives.
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National Hospice and Palliative Care Organization Calls for Increased Access to Palliative Care in Critical Care Settings
BUSINESS WIRE --The National Hospice and Palliative Care Organization has issued a position statement calling for increased access to palliative care for patients in critical care settings.
More than one out of five deaths in the United States occur during or following admission to an Intensive Care Unit. At this critical time, palliative care providers can complement the knowledge and skills of critical care professionals in the areas of symptom management, assistance with decision making, and end-of-life care.
There are times when a given technology is not achieving the hoped-for benefit or is too difficult for the patient to continue. Additionally, patients overwhelmed with symptoms such as pain, difficulty breathing, or confusion, and families of patients in the ICU must oftentimes address difficult medical decisions. These individuals would all benefit from the availability of palliative care.
“The focus of critical care is primarily to saves lives,” commented J. Donald Schumacher, NHPCO president and CEO. “This is not always possible – not because of any lack of excellence on the part of critical care physicians, nurses, and others, but because some patients’ diseases are too advanced or their injuries are too severe. There are times when patients need additional care and support. They need palliative care.”
NHPCO determined that there was sufficient concern related to the provision of palliative services in critical care settings to warrant the statement and call to action which was created by NHPCO’s Ethics Committee.
Strengthening access to palliative care in all critical care settings and promoting collaboration among all who are involved in this effort are the goals of NHPCO’s call to action.
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The Melanoma Research Foundation Introduces "Ask a Nurse" Program
Melanoma, the most serious type of skin cancer, is one of the fastest growing cancers in the U.S., and can strike people of all ages, all races and both sexes. In fact, with a one in 50 lifetime risk of developing melanoma, this year more than 62,000 Americans are expected to be diagnosed with the disease, resulting in an estimated 8,400 deaths. Melanoma is the most common form of cancer for young adults 25- to 29-years-old and the second most common cancer in adolescents and young adults 15- to 29-years-old.
The Melanoma Research Foundation (MRF) recently announced a new resource for those with questions about melanoma. Through the "Ask a Nurse" program, people have free access to an expert for guidance or to ask basic questions about melanoma, the most serious type of skin cancer.
"Although melanoma is the fastest growing cancer in the U.S. and worldwide," said Randy Lomax, chairman of the MRF, "there is still much to be done in terms of public education. The Melanoma Research Foundation is excited to add the 'Ask a Nurse' program to our existing library of resources for melanoma patients and those who care for them. With this service, there is no need for a referral, prescription or appointment; all you need once you go online is an e-mail account."
All questions directed to "Ask a Nurse" - askanurse@melanoma.org - are answered by Suzanne McGettigan, MSN, CRNP, ANP-BC, AOCN, an oncology nurse practitioner instructor at the Abramson Cancer Center at the University of Pennsylvania. In most cases, McGettigan responds to inquires within 72 hours.
"I am thrilled to be able to share my knowledge and experience directly with those who need it most," said McGettigan. "With more than 62,000 Americans expected to be diagnosed with melanoma this year alone, more people that ever before are looking for credible information about disease."
McGettigan added that while the program does not replace a patient's healthcare team, the MRF can help people find additional information and personalized answers beyond what can typically be found searching the Internet.
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Thursday, September 4, 2008
FDA Approves DNA Test to Measure Hepatitis B Virus Levels
The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient’s blood. Assessing a patient’s viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.
The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual’s response to therapy. (The baseline level of hepatitis B virus should decrease with successful treatment.) The test is used with other clinical findings, such as results from biochemical and serological testing.
“Measuring a patient’s HBV viral load is an important aspect of managing chronic hepatitis B infections,” said Daniel G. Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “The COBAS TaqMan test gives health care providers a new and sensitive tool for this process.”
HBV is the most serious type of viral hepatitis, infecting about two billion people worldwide each year, according to the World Health Organization. A vaccine for HBV has been available in the United States since 1982. However, according to the Centers for Disease Control and Prevention, about 1.25 million people in the United States have chronic hepatitis B. Another 60,000 become infected each year and some 5,000 die from hepatitis B-related complications.
HBV is spread through sexual exposure, use of infected needles, and transmitted from infected mother to child during birth. Symptoms occur in about 70 percent of patients, and include abdominal pain, jaundice, fatigue, loss of appetite, nausea, and vomiting.
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Arteries Have Unique Immune Functions
Human arteries play distinct roles in the immune system depending on their anatomical location, researchers at Emory University School of Medicine have discovered.
Their findings explain why vascular diseases affect different parts of the arterial network and could help doctors fine-tune the treatment of such diseases as atherosclerosis and vasculitis. Atherosclerosis causes heart attacks and strokes because it occurs preferentially in arteries supplying the heart and the brain.
The results were published online this week by the journal Circulation.
Arteries can play an active role in sensing foreign invasion and bodily injury, because cells embedded in the arterial walls called dendritic cells act like smoke-sensing fire alarms for the immune system, says senior author Cornelia Weyand, MD. PhD, co-director of the Kathleen B. and Mason I. Lowance Center for Human Immunology at Emory University.
"All of our major arteries have this alarm system," she says. "To our surprise, we found that the arteries of the neck, the arms, the abdomen and the legs are triggered by different infectious organisms. Thus, each artery functions in a specialized way."
Some vascular diseases attack arteries only in the abdomen or in the neck and upper extremities, and this selectivity has puzzled doctors for years, Weyand says.
To probe the differences among arteries, Weyand and her co-workers examined the activity of genes that encode Toll-like receptors in blood vessels from human donors.
Toll-like receptors are a cornerstone of the "innate" immune system, which can be activated by common features of infection-causing invaders. The capture of bacterial or viral fragments through Toll-like receptors alerts the immune system early during an infectious attack. Toll-like receptors can respond to whip-like antennas on bacteria called flagellae, parts of bacterial cell walls, or DNA and RNA that leaks from viruses or bacteria.
Each type of artery had a different set of Toll-like receptor genes turned on, the authors found. In contrast to arteries, veins could not be stimulated through Toll-like receptors.
For example, cells in the iliac arteries, located in the vicinity of the gut, respond avidly to flagellae but cells from the subclavian arteries, which transport blood to the upper body, do not.
A possible explanation is that dendritic cells from iliac arteries are better able to sense flagellae because of the abundant bacterial flora that inhabits the gut, Weyand says.
Weyand hypothesizes that the dendritic cells in arteries are mainly performing a protective, calming function. Arteries are in constant contact with blood borne infectious agents, with potentially dangerous consequences of damaging the vessel wall.
"It's when that protective function breaks down that we see inflammation and various vascular diseases," she says.
She says her team is now investigating how the dendritic cells in arteries move and change as they receive various signals.
The first author of the paper is research specialist Olga Pryshchep, with contributions from postdoctoral fellow Wei Ma-Krupa, PhD, Joerg Goronzy, MD, PhD, co-director of the Lowance Center, and Brian Younge, MD, of the Mayo Clinic.
The research team used samples from 37 deceased donors with an average age of 64. Only arterial samples without atherosclerotic lesions were used.
The research was funded by the National Institutes of Health, the Dana Foundation and the McIntyre Family Discovery Fund.
Reference: Vessel-specific Toll-like receptor profiles in human medium and large arteries Circulation, Sep 2008; doi:10.1161/CIRCULATIONAHA.108.789172
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FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.
The four drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system, are approved to treat a variety of conditions which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.
FDA today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of TNF inhibitors to make safety-related changes to prescribing information, or labeling.
“Under the FDA's new authorities, we can require safety label changes and a risk evaluation and mitigation strategy, known as REMS, when the agency becomes aware of new safety information,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research. “Requiring the risks to be highlighted will help health care professionals be more vigilant in watching for these adverse events, and is necessary to ensure that the benefits of these drugs outweigh their risks.”
Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on reports reviewed by FDA, health care professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment.
Patients taking TNF blockers should be aware that they are more susceptible to serious fungal infections. Those who develop a persistent fever, cough, shortness of breath, and fatigue should promptly seek medical attention. To assist in the diagnosis, those being treated with TNF blockers should tell their health care professionals where they live and what areas they have recently visited. Patients who develop a fungal infection may be advised to stop the TNF blocker until they recover.
FDA has reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys (the fungus is commonly found in those areas). In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.
The FDA reviewed one reported case of histoplasmosis in a patient taking Cimzia. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF blockers.
TNF blocker manufacturers are required to submit safety labeling changes, including strengthened warnings and revisions to the Medication Guides to the FDA within 30 days or to provide a reason why they do not believe labeling changes are necessary.
If they do not submit new language, or if the FDA disagrees with the new language the company proposes, the Food and Drug Administration Amendments Act of 2007 provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information.
Medication Guides will become part of a REMS for Humira and Remicade and are already part of a REMS for Enbrel and Cimzia. The manufacturers for all four of these drugs will also be required to educate prescribers about the risks.
For more information: http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm
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FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures
The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.
“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health, FDA. “While the software doesn't fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”
Implantable defibrillators are used to treat patients at risk of experiencing life-threatening heart rhythm abnormalities. Should an abnormality occur, the defibrillator delivers a pulse of energy through a lead, a thin electronic wire, shocking the heart back into normal rhythm.
The Sprint Fidelis lead, the subject of an October 2007 Medtronic recall, was prone to fracture in a small number of patients, potentially causing the lead to deliver unnecessary shocks or not operate at all. Most of the patients with the Sprint Fidelis lead still have the device implanted because of the surgical risk associated with removal, and are being monitored by their health care providers for potential fracture.
Medtronic's new software feature, called the Lead Integrity Alert, issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
Medtronic has agreed to actively monitor the performance of the new software feature in actual use, which will allow both the company and FDA to ensure that the device is protecting patients as intended.
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Alte Biosciences Files Patent for New Inflammatory Bowel Disease Drugs
(BUSINESS WIRE)--Alte Bioscience, Inc., a development stage pharmaceutical company, is pleased to announce the filing of a provisional patent for a new class of drugs that may benefit patients with inflammatory bowel disease. This is the latest in a series of pharmaceutical inventions held by Alte Biosciences, adding to its portfolio of patents of drugs for the treatment of late onset depression and innovative systems for drug delivery, packaging, and manufacturing. The composition of matter in the new filing was discovered in collaboration with PharmaDirections, Inc.
Dr. Richard Soltero and Dr. Bruce Rehlaender of PharmaDirections are the co-inventors on the patent application entitled “A COMPOSITION AND METHOD FOR THE TREATMENT OF A GASTROINTESTINAL DISORDER.” PharmaDirections, under contract to Alte Biosciences, developed these innovative molecules to treat inflammatory bowel disease, (IBD) - a chronic syndrome that afflicts the digestive tract and is usually defined by an uncontrolled inflammatory response at the gut epithelial layer. Each molecule consists of two mutual pro-drugs that release medicines that are well known in the treatment of IBD. PharmaDirections will develop specialized formulations to deliver these molecules in ways that will improve their anti-inflammatory, anti-microbial and cytoprotective properties.
“We are pleased that our research efforts resulted in the identification of new chemical entitles that have the potential to benefit patients with inflammatory bowel disease,” stated Dr. Thomas Colatsky, CSO of Alte Biosciences. “Our ability to harness the talent and skills of PharmaDirections’ scientific staff in our pipeline development efforts has paid significant dividends, as evidenced by this latest discovery.”
Inflammatory bowel disease affects nearly 2 million people worldwide, and has two recognized manifestations: Crohn’s disease and ulcerative colitis. Crohn’s disease, also known as regional enteritis, can occur anywhere in the gastrointestinal tract from mouth to anus. Most commonly, it is found in the terminal ileum/proximal colon and is characterized by distinct ulcerations that run deep into the epithelial tissue. Ulcerative colitis is only found in the colon, with the greatest majority of patients exhibiting effects in the terminal colon. The patent filed by Alte Biosciences claims separate compositions of matter for treating each of these disease states. These treatments offer the possibility of improved efficacy by targeting drug to the sites of inflammation, while reducing the prevalence of gastrointestinal side effects associated with current treatments.
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Wednesday, September 3, 2008
New Research Shows Promise for Finding A Cure for Rheumatoid Arthritis
PRNewswire/ -- For the first time during its unprecedented initiative to find a cure for rheumatoid arthritis, the American College of Rheumatology Research and Education Foundation is releasing new information acquired from research funded by the Within Our Reach: Finding a Cure for Rheumatoid Arthritis campaign.
Doctors and scientists from across the nation are utilizing more than $12 million in grants awarded by the ACR REF to investigate critical issues including early detection of RA, novel treatment pathways as well as improved patient-provider interaction and patient care. While research is still underway, the REF is encouraged by the progress made thus far and is pleased to announce the new and promising knowledge which RA researchers will continue to build upon as studies continue.
"The REF is committed to funding RA research that is not being done elsewhere, and supporting scientists and doctors who are most prepared and motivated to work on finding a cure," said Dr. Leslie J. Crofford, president of the REF. "The quality and value of the studies in progress is evidence that the Within Our Reach campaign to is critical and must continue."
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Truth and Consequences and Enrollment in Clinical Trials
Knowing about financial relationships between medical researchers and the companies that sponsor their studies has little effect on most patients considering enrolling in a clinical trial, according to a new study from the Duke Clinical Research Institute.
"The patients in our study were very clear: They told us they care about these relationships and want to be fully informed about them. But at the same time, the information didn't substantially affect their decision to enter a trial," says Dr. Kevin Weinfurt, a medical psychologist at Duke and the lead author of the study.
What seemed to be more important in the decision-making process was the patients' pre-existing level of trust in medical research in general, Weinfurt says.
The findings, appearing online in American Heart Journal, reveal that patients are astute enough to draw distinctions between various types of financial arrangements, finding some reasonable, and others, less so.
Researchers from Duke University Medical Center, Johns Hopkins Berman Institute of Bioethics and Wake Forest University conducted a telephone survey of 470 patients diagnosed with coronary artery disease who agreed to go through a consent process involving enrollment in a hypothetical clinical trial.
Investigators first assessed the patients' overall level of trust in medical research through a four-item questionnaire and then randomized them into one of three disclosure groups.
Patients who were told that the doctor leading the study also held stock in the company sponsoring the research were the least willing to participate in the study. They also spontaneously offered three times the number of negative comments about the relationship than participants in the other groups, using words like, "disingenuous," "unacceptable," and "unethical." Ten members of this group also spontaneously said they would not take part in a trial where the lead investigator held stock in the company sponsoring the trial.
Patients who were told that the sponsoring company covered the cost of the trial, including the physician's salary, were generally accepting of such a financial relationship, saying, "OK, that sounds more appropriate. So there's no payment to him, but through the university. OK, I'm good."
Participants in the study were disproportionately middle-to higher income white men, and the researchers say lower income participants from other racial groups might feel differently about financial relationships between researchers and sponsoring companies.
"We clearly live in a time of heightened sensitivity about these matters," says Jeremy Sugarman, M.D., Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Johns Hopkins Berman Institute of Bioethics and senior author of the study, who says the research offers implications for health care policy. "Policy makers may want to consider more restrictive policies for equity relationships than for other financial interests in research."
The study was funded by a grant from the National Heart, Lung, and Blood Institute.
Other researchers from Duke who were involved in the study include Joelle Friedman, Chantelle Hardy, Alice Fortune-Greely, Janice Lawlor, Jennifer Allsbrook, Li Lin and Kevin Schulman. Mark Hall, from Wake Forest University, also contributed to the study.
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Tuesday, September 2, 2008
Study Indicates It's Never too Late for Exercise-- Even in Stroke Victims
People who walk on a treadmill even years after stroke damage can significantly improve their health and mobility, changes that reflect actual "rewiring" of their brains, according to research spearheaded at Johns Hopkins.
"This is great news for stroke survivors because results clearly demonstrate that long-term stroke damage is not immutable and that with exercise it's never too late for the brain and body to recover," says Daniel Hanley, M.D., professor of neurology at the Johns Hopkins University School of Medicine.
The study's results, published in Stroke: Journal of the American Heart Association, suggest that patients' brains may retain the capacity to rewire through a treadmill exercise program months or years after conventional physical therapy has ended.
The research was conducted by scientists at Johns Hopkins, the University of Maryland, and the Department of Veterans Affairs Maryland VA Medical Center at their Geriatric Research, Education, and Clinical Center (GRECC). Researchers at the GRECC, led by Richard F. Macko, M.D., and Andrew P. Goldberg, M.D., have developed treadmill therapy for stroke patients over the past decade. Investigators at all three institutions combined efforts to recruit 71 patients who had a stroke at least six months earlier, with an average time lapse of nearly four years. At the study's onset, half of the subjects could walk without assistance, while the rest used a cane, a walker or a wheelchair.
All of the subjects, separated into two random groups regardless of disability, were tested for mobility and aerobic capacity (also known as VO2 peak), a measure of cardiac fitness. Thirty-two patients drawn equally from both groups underwent functional magnetic resonance imaging (fMRI) to assess brain activity linked to moving their legs in a walking motion.
One group then participated in an exercise program that principally involved walking on a treadmill three times a week for up to 40 minutes, assisted by a supporting sling and tether if needed. Physical therapists assigned to each subject increased the intensity of the workouts over time by increasing the treadmills' speed and incline, though the workouts never taxed the patients beyond a moderate level of 60 percent VO2 peak.
With the second group of patients, therapists assisted the patients in performing stretching exercises for the same period of time.
After six months, patients were again tested for walking speed and VO2 peak, and the same group who had undergone fMRI was rescanned. Walking speed for the treadmill group increased 51 percent compared to about 11 percent faster for those in the stretching group. Ground walking speed among the treadmill exercisers increased 19 percent, compared to about 8 percent for the stretchers. The treadmill exercisers also were significantly more fit at study completion, with VO2 peak increasing by about 18 percent. VO2 peak decreased slightly in the stretching group.
Hoping to find evidence that improved brain activity was responsible for the results, the investigators analyzed the brain scans and found markedly increased metabolic activity in brainstem areas associated with walking among all the treadmill exercisers. Brain scans of patients in the stretching group showed no such changes.
"This suggests that the brain is responsible for the improvement we saw in patients' walking ability. It seems to be recruiting other regions to take on the job of areas damaged by stroke," says Andreas Luft, M.D., a visiting researcher who worked with all three institutions who conducted this study. Luft is currently a stroke attending physician and professor of neurorehabilitation at the University of Zurich in Switzerland.
Those patients with the most improvement in walking showed the strongest change in brain activity, though the researchers don't yet know whether these brain changes were caused by more walking or whether participants walked better because brain activity in these key areas increased. This question will be the focus of a future study.
Hanley says stroke patients are typically told to "learn to live with" their disabilities, unlike heart attack patients and others who are often prescribed lifestyle changes and exercise programs to help recover function. Most stroke rehabilitation programs focus on short-term improvement, ending just a few months after a patient has had a stroke. Consequently, over the following years, patients' functional improvement plateaus and their fitness often wanes-a factor that could increase the chance of a second stroke.
"Many stroke survivors believe there's nothing to be gained from further rehabilitation, but our results suggest that health and functional benefits from walking on a treadmill can occur even decades out from stroke," says Macko, professor of neurology at the University of Maryland School of Medicine, noting that one of the patients in the study had significant improvement 20 years after a stroke. "We believe exercise gives individuals a way to fight back against stroke disabilities."
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