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Press Release - Nov 28, 2008
Brigham and Women’s Hospital receives American Stroke Association’s Get With The Guidelines Gold Performance Achievement Award
Brigham and Women’s Hospital (BWH) recently received the American Stroke Association’s Get With The GuidelinesSM–Stroke (GWTG–Stroke) Gold Performance Achievement Award. The award recognizes BWH’s commitment and success in implementing a higher standard of stroke care by ensuring that stroke patients receive treatment for at least 24 months according to nationally accepted standards and recommendations.
“During a stroke, time is of the utmost importance because time loss translates into brain loss. In achieving this award, we have addressed the important element of time,” said Steven Feske, MD, director of the Stroke Division.
BWH’s Stroke Division has developed a comprehensive system for rapid diagnosis and treatment of stroke patients admitted to the emergency department. This includes always being equipped to provide brain imaging scans, having neurologists available to conduct patient evaluations and using clot-busting medications when appropriate.
To receive the GWTG-Stroke Gold Performance Achievement Award, BWH demonstrated 85% adherence in the GWTG–Stroke key measures for 24 or more consecutive months. These include aggressive use of medications like tPA, antithrombotics, anticoagulation therapy, DVT prophylaxis, cholesterol-reducing drugs, and smoking cessation.
“The American Stroke Association commends Brigham and Women’s Hospital for its success in implementing standards of care and protocols,” said Lee H. Schwamm, M.D., national Get With The Guidelines Steering Committee Member and director of the acute stroke services at Massachusetts General Hospital in Boston. “The full implementation of acute care and secondary prevention recommendations and guidelines is a critical step in saving the lives and improving outcomes of stroke patients.”
GWTG–Stroke uses the “teachable moment,” the time soon after a patient has had a stroke, when they are most likely to listen to and follow their healthcare professionals’ guidance. Studies demonstrate that patients who are taught how to manage their risk factors while still in the hospital reduce their risk of a second heart attack or stroke. Through GWTG–Stroke, customized patient education materials are made available at the point of discharge, based on patients’ individual risk profiles. The take-away materials are written in an easy-to-understand format and are available in English and Spanish. In addition, the GWTG Patient Management Tool provides access to up-to-date cardiovascular and stroke science at the point of care.
“We are proud to receive this award at a time when focusing on this issue is of growing importance. The number of acute ischemic stroke patients eligible for treatment is expected to grow over the next decade due to increasing stroke incidence and a large aging population,” said Feske.
According to the American Stroke Association, each year approximately 700,000 people suffer a stroke — 500,000 are first attacks and 200,000 are recurrent. Of stroke survivors, 21 percent of men and 24 percent of women die within a year, and for those aged 65 and older, the percentage is even higher.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org
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Press Release - Nov 25, 2008
Exposure to Diesel Exhaust at Work Linked to COPD and Increased Risk of Death
Boston, MA – In a study of U.S. railroad workers, researchers from Brigham and Women’s Hospital’s (BWH) Channing Laboratory and the Harvard School of Public Health (HSPH) found that individuals who were regularly exposed to diesel exhaust at work may have had an increased risk of dying from chronic obstructive pulmonary disease (COPD). These findings appear in the September 2008 issue of the British Medical Journal.
COPD is a lung disease characterized by obstructed airways, difficulty breathing and is the fourth leading cause of death in the U.S. “There has been minimal research on the relationship between exposure to diesel exhaust and non-malignant pulmonary disease,” said Jaime E. Hart, ScD, Project Coordinator at BWH’s Channing Laboratory. “These findings can help provide researchers with direction regarding future research on the effects of diesel exhaust in today’s workplace.”
The researchers compared the death certificates of male railroad workers with and without diesel exhaust exposure, aged 40 to 64 years in 1959, with10 to 20 years of prior railroad work experience. After calculating the likely smoking history for the workers, a major contributing factor to COPD, and noting whether COPD was listed as a primary or secondary cause of death, researchers derived what the effects of exposure to diesel exhaust had on the likelihood of dying from COPD. With each additional year of exposure to diesel exhaust at work, an individual’s risk of dying from COPD increased by 2.1 percent.
Hart also explains,”Since the time period that the study investigated, the mid-twentieth century, technology and regulation have advanced. This study establishes a relationship between COPD mortality and diesel exhaust exposure in the workplace and encourages investigation of current trends in the locomotive and other industries where employees are regularly exposed to diesel exhaust.”
The research was funded by grants provided by the National Institute for Occupational Safety and Health, the National Institutes of Health and the National Cancer Institute.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org
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Press Release - Nov 24, 2008
Study of Diabetes Treatment Gives Elderly Diabetics Something New to Consider
Boston, MA – For patients with diabetes, thiazolidinediones (TDZs) are an oral treatment option for those who would otherwise have to resort to insulin shots to control their blood sugar levels. Researchers at Brigham and Women’s Hospital (BWH) compared the outcomes of the two TDZs available on the market today and found that in the group of patients using rosiglitazone, there was a higher occurrence of death and a greater risk of congestive heart failure (CHF) in elderly patients, when compared with those using the other TDZ, pioglitazone. The findings appear in the November 24, 2008 issue of Archives of Internal Medicine.
Shortly after rosiglitazone and pioglitazone entered the market, it became apparent that both had important adverse effects, most importantly CHF. Previous study of the drugs yielded results suggesting an increased risk of CHF for both, and an increased risk of myocardial infarction (MI) for those using rosiglitazone,. In studies of pioglitazone, however, it was suggested that patients had a lower risk of MI or stroke as compared to those in the study that did not receive the drug.
“Because there was limited data that directly compared the two drugs, we wanted to look specifically at the comparative risks of each,” said Wolfgang Winkelmayer, of the Pharmacoepidemiology and Renal Divisions at BWH and lead author of the study. “We wanted to determine whether older patients should consider certain risks when deciding whether to take one drug over the other.”
To examine the relative effects of rosiglitazone and pioglitazone, researchers looked at the medical information available for 28,361 Medicare beneficiaries aged 65 years and older who had diabetes and initiated treatment with one of the two TDZs.
After looking at the number of patients who died while on one of the drugs, researchers found that patients taking rosiglitazone were at a higher risk of death, with 15 percent greater mortality among patients using rosiglitazone. In addition, the occurrences of MI, stroke and CHF in patients were examined, and the group taking rosiglitazone exhibited a 13 percent greater risk of CHF. However, the study did not establish any differences in the risk of MI or stroke between the groups of patients taking the two drugs.
“This could be valuable information for elderly diabetic patients who are considering a TDZ, as well as for physicians prescribing these drugs to patients,” said Dr. Winkelmayer.
The research was funded by the American Heart Association.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Nov 17, 2008
Serial PSA Screening for Prostate Cancer May Reduce Risk of Recurrence
Boston, MA – Controversy about prostate-specific antigen (PSA) screening remains in the absence of large, randomized clinical trials that compare the benefits of screening vs. not screening. Patients and health care providers alike are confused about the current role of PSA screening and how to screen patients while waiting on definitive results of those trials. New research at Brigham and Women’s Hospital finds that serial PSA screening may play a role in improving outcomes for patients who are diagnosed with prostate cancer. These findings are published online and will appear in an upcoming print issue of CANCER.
“Men who were serially screened were diagnosed at an earlier stage and with more favorable PSA levels than men who had not had serial screening prior to diagnosis,” said Paul Nguyen, MD, lead author of the study and a chief resident in the Harvard Radiation Oncology Program at the Dana-Farber Brigham and Women’s Cancer Center. “This supports the notion that serial PSA screening could lead to the diagnosis of prostate cancers at more curable stages, which could potentially result in lower death rates from prostate cancer.”
Researchers evaluated nearly 2000 men with prostate cancer who had surgery, radical prostatectomy, to treat their prostate cancer. Patients were separated into two groups, those who had a history of regular, repeated PSA screenings before being diagnosed with prostate cancer and those who were diagnosed with prostate cancer as a result of their first PSA screening. Nguyen and colleagues found that men who had had PSA screening at regular intervals prior to their diagnosis had a substantially lower risk of recurrence than men who had not had prior serial screenings. This effect remained significant even when the analysis was controlled for stage, PSA level, and gleason score, which are the factors doctors typically use to predict a patient’s risk of recurrence.
“This research adds to the growing body of evidence showing the success of PSA screening, said Anthony D'Amico, MD, PhD, chief of Genitourinary Radiation Oncology at BWH and senior author of the paper. "Without serial PSA screening, recurrence rates of prostate cancer after surgery are 80 percent higher.”
“Patients who are diagnosed with prostate cancer the first time their PSA is checked may harbor more aggressive disease than their Gleason grade, PSA level, and stage would suggest, and may therefore need to be considered for more aggressive therapy than patients who have been screened serially” Nguyen said.
Researchers emphasize that more research is needed and that the most conclusive evidence will come in the form of results from randomized trials, which are expected in a few years. This research was conducted as a collaboration with Dr. William J. Catalona of the Northwestern University Fineberg School of Medicine Department of Urology.,
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Nov 9, 2008
Rosuvastatin Dramatically Reduces Heart Attack, Stroke and Total Mortality Among Men, Women with Low Cholesterol but Elevated C-Reactive Protein Level
hsCRP Important for Effective Heart Disease Detection and Treatment
Boston, MA – Until now, there has been no proven method to detect and prevent the many heart attacks and strokes that occur in patients with normal or low cholesterol levels. In the landmark JUPITER trial of 17,802 patients, researchers from Brigham and Women’s Hospital (BWH) report that rosuvastatin reduces by nearly fifty percent the risk of heart attack, stroke, and cardiovascular death among apparently healthy men and women participating in the trial who had low levels of cholesterol but were nonetheless at high risk for vascular disease due to increased levels of a simple blood test for the inflammatory biomarker hsCRP (high sensitivity C-reactive protein). These findings appear in the November 20, 2008 issue of the New England Journal of Medicine and will be presented November 9th at the 2008 Scientific Sessions of the American Heart Association. The New England Journal of Medicine will also publish the findings online November 9, 2008.
In the JUPITER trial which focused on low cholesterol/high hsCRP patients, a daily regimen of rosuvastatin was associated with a 54 percent reduction in heart attack, a 48 percent reduction in stroke, a 46 percent reduction in need for angioplasty or bypass surgery, and a 20 percent reduction in all-cause mortality compared to participants who were given a placebo. These effects are nearly twice as large as what doctors expect when using statin therapy among patients with high cholesterol, demonstrating the importance of elevated hsCRP as a major risk factor for cardiovascular disease. Among trial participants with elevated hsCRP but no other risk factors, rosuvastatin reduced cardiovascular events by 37 percent. There was no difference between treatment groups for major adverse events, including cancer or myopathy. As in almost all prior statin trials, there was a small increase in reported diabetes.
Dr Robert Glynn, the academic study statistician, estimated that approximately 250,000 heart attacks, strokes, revascularization procedures, or cardiac deaths could be avoided in the US alone if the strategy tested in JUPITER was applied over a five year period.
“Our results are relevant for patient care and the prevention of heart attack and stroke,” said Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital and lead author of the study. “Physicians can no longer assume that patients are at low risk for heart disease simply because they have low cholesterol. We have confirmed that patients with increased hsCRP are at high risk even if cholesterol levels are low, and we now have evidence that a simple and safe therapy cuts that risk and saves lives.”
The JUPITER trial results also demonstrate for the first time that statin therapy is highly effective in the prevention of heart disease among women and minority patients, groups that typically have been excluded or understudied in prior trials. For example, rosuvastatin reduced the risk of cardiovascular events by 46 percent in women compared to 42 percent in men.
Started in 2003, JUPITER (the Justification for Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) was designed to test whether rosuvastatin, taken at 20mg daily compared to placebo, could reduce the risk of cardiovascular events among apparently healthy men and women who had LDL cholesterol levels below 130mg/dL who were nonetheless at silent risk due to increased levels of inflammation as measured by a simple blood test known as high sensitivity C-reactive protein (hsCRP).
Prior work had established that patients with increased hsCRP were at high risk for heart disease despite lacking other conventional risk factors, and that statins lower hsCRP levels, indicating anti-inflammatory as well as cholesterol lowering effects. Until JUPITER, whether or not statin treatment would be effective in reducing cardiac events among these patients had been uncertain.
“The JUPITER trial data are paradigm shifting and a win-win for patients and for health care providers” said Dr. Antonio Gotto, Dean of the Weill-Cornell Medical College in New York. “We should regularly measure hsCRP along with lipids when we determine cardiovascular risk.”
“For the cardiology world, discovering a major new risk factor as well as an effective treatment is like hitting a walk-off home run to win the World Series,” said Dr. Eugene Braunwald, a renowned cardiologist also at Brigham and Women’s Hospital.
The strategy of screening for hsCRP and treating those at high risk is likely to be cost-saving since rates of hospital admission and the need for expensive angioplasty and coronary artery bypass surgery were also reduced by nearly 50 percent among trial participants receiving rosuvastatin.
Participants in JUPITER had cholesterol levels widely considered optimal by most physicians; the average LDL or “bad” cholesterol was just above 100 mg/dL and the average HDL or “good” cholesterol was nearly 50 mg/dL. Nonetheless, event rates in the trial were high because all participants had elevated levels of hsCRP.
“JUPITER should dramatically change prevention guidelines” said Dr. James Willerson, Director of the Texas Heart Institute in Houston. “The bottom line here is simple – if your hsCRP is high, you should be on statin therapy regardless of your cholesterol level. This is an approach we can start using tomorrow”.
Led by Dr. Ridker of BWH, JUPITER was a randomized, double-blind, placebo-controlled trial conducted by investigators in 26 countries and overseen by an academic statistician (Robert Glynn, PhD, Harvard University, USA) and an independent Data and Safety Monitoring Board (chaired by Professor Rory Collins, Oxford University, UK). The study was funded by AstraZeneca, US who had no access to unblinded trial data and played no role in analysis or interpretation of the study data nor in manuscript preparation. Dr. Ridker is listed as a co-inventor on patents held by BWH that relate to the use of inflammatory biomarkers in cardiovascular disease that have been licensed to AstraZeneca and Siemens Healthcare Diagnostics in the therapeutic and diagnostics field respectively.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Nov 9, 2008
New Risk Assessment Tool Using CRP and Family History More Accurately Predicts Cardiovascular Risk
Web-based application shows patients and doctors how risk can be dramatically reduced
Boston, MA – Using data collected from nearly 11,000 initially healthy American men, researchers from Brigham and Women’s Hospital (BWH) have devised a Web-based formula that uses information on C-reactive protein and family history to more accurately predict risk of heart attack, stroke, or cardiovascular death among men. In addition to usual risk factors like age, cholesterol, blood pressure, and smoking, the new assessment tool known as the Reynolds Risk Score for Men adds information on two additional factors, parental history of heart attack prior to age 60 and blood level of high sensitivity C-reactive protein (hsCRP), a measure of artery inflammation. Using the new risk assessment tool, the researchers found that nearly 20 percent of men in the study could be reclassified into higher or lower-risk categories with greatly improved accuracy. The findings appear in the journal Circulation in an advanced online version November 9, 2008. The Reynolds Risk Score for Men parallels the Reynolds Risk Score for Women that was released in 2007 and rapidly adopted by the preventive cardiology community.
For the millions of American men currently classified at “intermediate risk,” use of the Reynolds Risk Score provides doctors and their patients a much clearer picture of expected risk and therefore is an important step towards “personalized medicine” to ensure that the right preventive therapies are given to the right patients. Application of the new Reynolds Risk Score for men should help physicians decide where the greatest impact of diet and exercise can be made, and will help to better target therapies including aspirin and statins.
“Beyond providing an opportunity for improved risk classification for men similar to that currently available for women, we believe these findings have potential importance for more accurately targeting preventive therapies,” said cardiologist Paul Ridker, director of the Center for Cardiovascular Disease Prevention at BWH and lead author of the study. “The findings further demonstrate the important role that inflammation and parental history can have in risk prediction, even in the setting of optimized access to preventive care.”
The Reynolds Risk Score for men derived from an evaluation of 10,407 initially healthy men enrolled in the Physician’s Health Study II in 1995 who were followed prospectively for more than a decade for the occurrence of first heart attack, stroke, and other major cardiovascular events. The researchers first evaluated traditional approaches to risk prediction in these men using a model based on cholesterol level, history of smoking, blood pressure and age. They then added family history of heart attack prior to age 60 and hsCRP level, and directly compared the new prediction tool to the traditional approach. The two new risk factors proved crucial to better understanding cardiovascular risk in these men, each representing an important advance in the biology of heart disease.
“Using the Reynolds Risk Score, we found that about 20 percent of all men had either higher or lower cardiac risk than we would have presumed based on more traditional approaches” Ridker explained. “Correctly classifying risk is crucial for those of us trying to get the right preventive drug to the right patient and to do so as cost-effectively as possible”. The new risk prediction algorithm comes on the heals of the large-scale JUPITER trial demonstrating that individuals with elevated hsCRP levels markedly benefit from statin therapy.
Both the Reynolds Risk Score for Men and the Reynolds Risk Score for Women are freely available at www.ReynoldsRiskScore.org. In addition to providing men and woman with an improved estimate of their risk of suffering a future heart attack, stroke, or other major cardiovascular event over the next 10 years, the Reynolds Risk Score website simultaneously shows each person what his or her risk would be if they improved each of their individual risk factors to optimal levels. For some young people, risk may appear low over the next 10-years, yet can be very high over a lifetime. The Reynolds Risk Score also allows people to calculate risk as they age, demonstrating the impact that risk reduction early in life can have on future events. The Reynolds Risk Score website provides useful links to prevention programs from the National Heart Lung and Blood Institute, the American Heart Association, and the American College of Cardiology.
Development and validation of the Reynolds Risk Score was supported by investigator-initiated grants from the Donald W. Reynolds Foundation, Las Vegas, Nevada and by funds from the National Heart Lung and Blood Institute, Bethesda, Maryland. Dr Ridker is listed as a co-inventor on patents held by the Brigham and Women’s Hospital that relate to the use of inflammatory biomarkers including CRP in the detection and treatment of cardiovascular disease. Other BWH investigators involved in the project include Nina Paynter, Michael Gaziano, Nader Rifai, and Nancy Cook.
Related Links
JUPITER trial resutls
Cardiovascular Center of Excellence
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Nov 9, 2008
No Cardiovascular Protection from Vitamin E or C
Both vitamin E and vitamin C are antioxidant supplements that are taken by many American adults with the belief that they offer protection against chronic conditions such as cardiovascular disease. However, new research from Brigham and Women’s Hospital (BWH) finds that neither vitamin E nor vitamin C supplements protect against cardiovascular disease in middle-aged and older men. This research was presented at the American Heart Association’s (AHA) Scientific Sessions 2008 and published simultaneously online in the Journal of the American Medical Association (JAMA).
“There has been great interest in antioxidants in the prevention of disease. Our study shows that vitamin E and vitamin C supplements are not effective in the prevention of cardiovascular disease for middle-aged and older men. People should continue to focus on eating a healthy diet, exercising regularly and controlling known risk factors such as high cholesterol and high blood pressure to reduce the risk of cardiovascular disease,” said Howard D. Sesso, Sc.D., M.P.H., Project Director of Physicians Health Study II at Brigham and Women’s Hospital and lead author of the paper published in JAMA.
Researchers studied more than 14,000 male physicians who took either a vitamin E or C supplement or its placebo, depending upon the group to which each physician had been randomly assigned. Over an average of eight years follow-up, participants provided annual updates on their pill-taking, potential side effects, risk factors for disease, medication use, and new disease diagnoses. Researchers were able to access participant’s medical records when necessary to confirm participant reports of cardiovascular events or cause of death. After analyzing participant data, researchers found that neither vitamin reduced the risk of cardiovascular disease in men.
“Unlike most previous studies in which vitamins E and C were given in combination with other antioxidants, this study investigated the two vitamins individually. Our findings add to the growing consensus about vitamin E and C’s lack of cardiovascular protection,” said J. Michael Gaziano, M.D., M.P.H., Principal Investigator of the study and a cardiologist at Brigham and Women’s Hospital and VA Boston, Boston, Mass. Dr. Gaziano presented these results as a late breaking clinical trial at the AHA Scientific Sessions.
This research was funded by the National Institutes of Health and BASF Corp. (Florham Park, N.J.). Supplements and packaging was provided by BASF, Wyeth Pharmaceuticals (Madison, N.J.), and DSM Nutritional Products, Inc. (Parsippany, N.J.).
Related Links
Physicians' Health Study
Division of Preventive Medicine
Cardiovascular Center of Excellence
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Nov 6, 2008
Self-assembling Nano-fiber Gel Delivers High Concentrations of Clinically Approved Drugs
BOSTON, MA - Researchers from Brigham and Women's Hospital (BWH) and City College of New York have developed a new self- assembling hydrogel drug delivery system that is biocompatible, efficient at drug release, and easy to tailor. The findings, which are now available online at Science Direct, will be published in the November 25 issue of Biomaterials.
These new structures can deliver clinically approved drugs in high concentrations without requiring carriers for the drug or generating toxic components, a problem with hydrogel systems until now.
"This strategy could serve as the platform technology for developing drug-based delivery gels that can release drugs such as anti-inflammatory agents on demand in response to inflammation, for example," said Jeffrey Karp, PhD, a researcher in the Department of Medicine at BWH.
"Converting known, clinically-practiced drugs into amphiphilic molecules which can undergo self-assembly is the key development in our present research; this may eliminate the need for an external carrier for delivering drugs" says Praveen Kumar Vemula, PhD, research fellow in the Department of Medicine at BWH.
The self-assembling nano-fiber gel is developed from drug-based hydrogels and can release drugs on demand, through enzyme triggered gel degradation.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Nov 5, 2008
Multiple Sclerosis Progression Can Be Predicted With MRI
Gray Matter Imaging May Lead to More Accurate Identification of Those At-risk
Researchers at Brigham and Women’s Hospital (BWH) have shown that MRI scans used on multiple sclerosis (MS) patients to determine if the disease has affected gray matter in the brain can identify those at-risk for progression of disability. This research is published in the current issue of the Journal of Neuroimaging.
MS affects approximately 400,000 people in the United States and as many as 2.5 million worldwide. It is the most common cause of progressive disability in young adults. While the cause of the disease remains unknown, it is characterized by damage to the covering over the nerve fibers in the brain and spinal cord, or to the nerve fiber itself.
In an attempt to understand the causes of disease progression, Dr. Rohit Bakshi, director of the Laboratory for Neuroimaging Research at Brigham and Women’s Hospital, and his team have developed new ways to detect gray matter damage. Researchers led a four year follow-up study, which found that patients with unnatural darkness of gray matter structures as seen on MRI pictures carried a higher risk for progression of physical disability. In addition, the researchers found that the new marker of gray matter damage showed closer correlations with patients’ clinical status than other established MRI markers of disease severity, including lesions, called plaques, and shrinkage of the brain, or atrophy.
“MRI scans obtained from patients with MS are being used to develop measures and techniques that can accurately measure the visible and hidden damage to the brain, especially in gray matter areas and can more accurately predict the course of the disease,” says Bakshi. “MRI-based measurement of gray matter damage may be used as a surrogate marker of disease progression so that physicians may be able to more accurately identify patients at risk for developing progressive disease,” he added.
MS has been traditionally viewed as a disease affecting the white matter of the brain, where messages are transferred between the brains gray matter sections, which control the processing of information. While prior research has shown that the brain’s gray matter is also affected, studies detailing its effects have been limited. In addition, current therapies for MS are incomplete, raising the need to better understand disease mechanisms and the biomarkers of disease progression. If excessive iron in gray matter contributes to damage, this would open a new avenue for developing better therapies.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Nov 4, 2008
Folic Acid, Vitamin B6 and B12 Do Not Lower or Increase Cancer Risk in Women
BOSTON, MA – Previous studies have shown a connection between folate, B6 and B12 vitamin intake and cancer prevention. Approximately one-third of adults in the United States take a daily multi-vitamin containing these supplements. Now, researchers from Brigham and Women’s Hospital (BWH) have found no association between folic acid, vitamin B6 and B12 intake and overall cancer risk in middle aged women. This research is published in the November 5, 2008 issue of the Journal of the American Medical Association.
“Women have been under represented when it comes to clinical trials with B vitamins. This study shows that combined treatment of folic acid, vitamin B6 and B12 provided neither beneficial nor harmful effects on overall risk of cancer for women aged 42 years or older with underlying cardiovascular disease or risk factors,” said Shumin Zhang, MD, ScD, lead author of the study and a researcher in the Division of Preventive Medicine at BWH.
Researchers assigned 5,442 female health professionals aged 42 years or older to receive either a daily combination of folic acid, vitamin B6 and B12 or placebo starting April 1998 through July 2005, when the US food supply began to be fortified with folic acid. The women either had preexisting cardiovascular disease or carried three or more risk factors for coronary disease. Of the participants, 187 who received the daily supplement developed invasive cancer compared to 192 who received the placebo. Researchers found that treatment with combined folic acid, vitamin B6 and B12 has no effect on total invasive cancer, breast cancer or deaths from cancer. Researchers note that there was a reduced risk for total invasive cancer and breast cancer observed in women who were 65 or older when enrolled in the study and were randomized to receive the combination folic acid, vitamin B6 and B12, but they cautioned that these subgroup findings may have been due to chance.
“Despite the apparent lack of benefit from these supplements for cancer prevention, several studies suggest that dietary sources of folate, such as dark green leafy vegetables, may lower cancer risk. Also, previous studies have shown conclusively that folic acid lowers the risk of certain birth defects, such as spina bifida, and adequate intake is important throughout pregnancy,” said JoAnn Manson, MD, DrPH, senior author of the paper and chief of Preventive Medicine at BWH.
This research was funded by the National Heart Lung and Blood Institute of the National Institutes of Health.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Nov 1, 2008
Therapeutic Potential of Stem Cells Augmented By Simple Chemical Procedure
BOSTON, MA - Adult stem cells resemble couch potatoes if they sit and divide in a dish for too long. They get fat and lose key surface proteins, which interferes with their movement and reduces their therapeutic potential. Now, via a simple chemical procedure, researchers at Brigham and Women’s Hospital (BWH) have found a way to get these cells off the couch and over to their therapeutic target. These findings were published online in Bioconjugate Chemistry on October 31.
To do this, researchers simply added a molecule called SLeX to the surface of the cells. The procedure took just 45 minutes and restored an important biological function.
"Delivery remains one of the biggest hurdles in stem cell therapy," explains Jeffrey Karp, PhD, a researcher in the Department of Medicine at BWH. "The blood stream offers a natural delivery vehicle, but stem cells don't move through blood vessels normally after being expanded in culture. Our procedure promises to overcome this obstacle."
In order for cells injected into the blood stream to be therapeutically useful, they need to take initiative to reach target tissues. But instead, cultured stem cells move with the natural blood flow. They travel through the body quickly, carried by the current, which means they seldom contact the sides of blood vessels. Thus, they have fewer opportunities to escape into the surrounding tissue. Adult stem cells must escape before they can colonize surrounding tissue and rebuild damaged structures.
Previously, BWH researcher Robert Sackstein showed that this problem could be corrected by adding a particular molecule to the surface of adult stem cells. This molecule - a cousin of SLeX - formed temporary connections with proteins on the blood vessel wall, serving as a kind of weak tape. However, Dr. Sackstein's method involved enzymes, which limits the potential modifications. Dr. Karp's team achieved the same result without enzymes.
Debanjan Sarkar, a fellow in the Renal Division at BWH, flooded a dish of cells with three molecules - biotin, streptavidin, and SLeX - one after the other. The biotin and streptavidin anchored SLeX to the cell surface. Sarkar tweaked the concentrations of each molecule to maximize the cell's ability to roll along the interior of the blood vessel, rather than getting lost in the flow. He also confirmed that the altered cells were still viable.
"The method is very simple," says Sarkar. "Plus, biotin and streptavidin work with many molecules, so labs can use this universal anchor we discovered to tackle other problems. They're not limited to sticking SLeX on cells."
The team worked with human cells extracted from the bone marrow. The cultures included mesenchymal stem cells (MSCs), which can form fat cells, cartilage, bone, tendon and ligaments, muscle cells, and even nerve cells. When injected into the bloodstream of patients, MSCs can home to the site of an injury and replace damaged tissue. Currently, only a fraction of cultured MSCs currently reach their target in clinical trials. Karp's procedure might improve their homing abilities.
The discovery must be validated in animals, before doctors can apply it in the clinic, notes Karp, who is collaborating with another lab to test the homing ability of the SLeX-dotted cells in mice.
"We need to confirm that this rolling behavior translates into increased homing and tissue repair," explains Karp. "We may need to tweak the cells a little further."
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Oct 13, 2008
No Link Between Caffeine Consumption and Overall Breast Cancer Risk
BOSTON, MA – Researchers at Brigham and Women’s Hospital (BWH) have dispelled a past belief that caffeine consumption may increase breast cancer risk. Their findings, published in the October 13 issue of Archives of Internal Medicine, show that caffeine consumption does not appear to be linked with overall breast cancer risk.
Caffeine, one of the most commonly consumed drugs worldwide, was previously thought to increase the risk of breast cancer after a study showed that women with non-cancerous breast disease experienced relief from their symptoms after removing caffeine from their diet. In this study, Ken Ishitani, MD, Ph.D, of BWH, and colleagues studied 38,432 women 45 years or older who provided dietary information in 1992-1995. Over an average of 10 years of follow-up, 1,188 of the women developed invasive breast cancer.
Although caffeine was not statistically significantly associated with overall risk of breast cancer, researchers note that there is a possibility of increased risk for women with benign breast disease or for tumors that are hormone-receptor negative or larger than 2 centimeters. This potential risk was observed in women with the highest consumption; four or more cups of coffee daily. Researchers also note that consuming caffeine was associated with a 68 percent increased risk of estrogen receptor–negative and progesterone receptor–negative breast cancer, or tumors to which the hormones estrogen and progesterone do not bind, and a 79 percent increased risk for breast tumors larger than 2 centimeters.
“The mechanisms by which caffeine may affect the development of breast cancer are complex and remain unclear. Our findings indicate that caffeine consumption may affect breast cancer progression, and such an effect may be independent of the estrogen pathway,” said Shumin Zhang, MD,ScD,MSC. “Further study is required to better understand caffeine’s role.”
This research was funded by the National Institutes of Health.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Oct 8, 2008
Nation's Top Healthcare Organizations Announce Strategies to Prevent Deadly Healthcare-Associated Infections
WASHINGTON, D.C. — For the first time, five leading healthcare organizations have come together to publish practical science-based strategies to help prevent the six most important healthcare-associated infections (HAIs). Titled the Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals, the strategies were authored by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA), with input from the American Hospital Association (AHA), the Association for Professionals in Infection Control and Epidemiology (APIC), and The Joint Commission.
HAIs are one of the nation’s most serious public health and patient safety issues. The Centers for Disease Control and Prevention (CDC) estimate that 2 million Americans contract an infection while receiving treatment and over 90,000 Americans will die as a result of complications from an infection each year. Hospital infections cost Americans between $4.5 billion and $6.5 billion in extra healthcare costs each year.
“The goal of all of us as healthcare providers is to offer the best and safest patient care possible. Not all HAIs are preventable, but we can make use of practices that we know are effective to prevent as many of these infections as possible,” said lead author of the strategies, Deborah S. Yokoe, MD, associate physician at the BWH Channing Laboratories and SHEA spokesperson. “We know that relying on the best science available will help get us to that goal.”
With the support or endorsement of an additional 21 healthcare organizations, the Compendium is expected to be a good starting point for addressing this critical public health crisis before it worsens. Infection control experts at SHEA and IDSA will assume responsibility for updating these strategies as science evolves.
“People should expect healthcare that is safe and free from additional complications, “said P.J. Brennan, MD, head of the federal Healthcare Infection Control Practices Advisory Committee and President of SHEA. “This effort will benefit healthcare providers, patients and their families and, just about everyone who walks in the hospital door because the strategies announced today identify what hospitals should be doing based on the latest scientific evidence and also provide performance measures to ensure accountability."
The urgency is heightened for acute care facilities to work toward eliminating HAIs. Beginning Oct. 1, 2008, the Centers for Medicare and Medicaid Services (CMS) will no longer reimburse hospitals for costs related to treating certain HAIs.
“These strategies clearly identify basic things all hospitals should be doing and how they can measure their progress through internal performance measures,” said Rich Umbdenstock, CEO of AHA. “Regardless of where a hospital falls on the spectrum of controlling HAIs, this compendium offers practical advice on specific steps they can take today to improve patient safety. These strategies work in a real life setting.”
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Oct 5, 2008
Prostate Cancer Mortality is Higher for Overweight Men with High Insulin Secretion Prior to Diagnosis
Boston, MA – Researchers from Brigham and Women’s Hospital (BWH) and colleagues found that excess bodyweight and high plasma concentrations of C-peptide (a protein that reflects the amount of insulin secretion) in men who are subsequently diagnosed with prostate cancer are reliable indicators that they are more likely to die from their disease than those with lower levels. This substudy of the Physician’s Health Study is found in an article published online on October 5, and in the November edition of The Lancet Oncology.
Jing Ma, MD, MPH, PhD, of the Department of Epidimiology at BWH, and colleagues assessed data from 2546 men diagnosed with prostate cancer during 24 years of follow-up in the Physician’s Health Study. The association between baseline BMI, baseline plasma C-peptide concentrations, and BMI measured at 8-years of follow-up and subsequent prostate cancer-related death was examined.
Several past studies have suggested that men who are overweight, as measured by body-mass index (BMI), have an increased risk of prostate-cancer progression and disease-related death. However, long-term, prospective data on prostate cancer-specific mortality have been scarce. Furthermore, although the high insulin concentrations associated with obesity could potentially explain the adverse effect of obesity on prostate cancer mortality, no studies had assessed the association between pre-diagnostic plasma concentrations of C-peptide and prostate cancer-specific mortality.
Using the Physician’s Health Study, researchers found that men who were overweight (BMI =25–29·9 kg/m2) or obese (BMI =30 kg/m2) before diagnosis were significantly more likely to die from their prostate cancer than men of normal weight (BMI <25 kg/m2).="kg/m2)." This="This" trend="trend" remained="remained" significant="significant" after="after" controlling="controlling" stage="stage" Gleason="Gleason" grade.="grade." Baseline="Baseline" were="were" available="available" for="for" 827="827" those="those" highest="highest" plasma="plasma" concentrations="concentrations" also="also" prostate-cancer="prostate-cancer" mortality="mortality" compared="compared" the="the" lowest="lowest" concentrations.="concentrations." Men="Men" with="with" both="both" C-peptide="C-peptide" concentration="concentration" and="and" high="high" BMI="BMI" prior="prior" to="to" diagnosis="diagnosis" prostate="prostate" cancer="cancer" had="had" a="a" four="four" times="times" higher="higher" risk="risk" disease-specific="disease-specific" mortality,="mortality," independent="independent" of="of" other="other" clinical="clinical" predictors.
The findings provide “further impetus for men to avoid becoming overweight and to decrease their risk of metabolic syndrome by physical activity and diet; and also adds to the rationale for investigation of new therapeutics and prevention strategies, such as use of insulin-lowering or anti-diabetic drugs,” says Dr Ma.
Researchers also note that measurement of a blood hormone level, even prior to the diagnosis of a cancer, allows one to predict the behavior of cancer that might arise many years in the future.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Sep 25, 2008
New Research Finds Drug-Eluting Stents Are More Effective for Heart Attack Patients Than Bare-Metal Stents
Boston, MA – Researchers from Brigham and Women’s Hospital (BWH) and Harvard Medical School (HMS), studying the long-term effectiveness of drug-eluting stents comp ared to bare-metal stents among patients who had an acute heart attack, found that patients who received drug-eluting stents had significantly lower mortality rates after two-years compared to patients who received bare-metal stents. This study used the largest cohort and longest follow-up time to date for stent comparison research in the US. The findings appear in the September 25, 2008 issue of the New England Journal of Medicine.
The researchers followed 7,217 patients from Massachusetts who were treated with a stent for a heart attack between April 1, 2003 and September 20, 2004 (4016 with drug-eluting stents and 3201 with bare-metal stents). Each drug-eluting stent patient was matched with a similar bare-metal stent patient and followed for two years. Overall, death rates were two percent lower during this time for patients with drug-eluting stents. The death rate was further lowered (3.1 percent) for patients who had an acute heart attack and received a drug-eluting stent compared to those receiving a bare-metal stent for the same type of heart attack and again in cases of less acute heart attacks (2.9 percent). Additionally, rates of repeated stenting were significantly reduced during the two year span for all of those in the study who received a drug-eluting stent.
"Heart attacks are a life threatening condition where physicians need to decide quickly what the best way is to open the blocked artery. We conducted this study to understand whether drug-eluting stents are safe in this situation. It is very reassuring that drug-eluting stents were actually associated with better survival and fewer repeat procedures," said lead author Laura Mauri MD, an interventional cardiologist at Brigham and Women’s Hospital and an assistant professor at Harvard Medical School. Dr Mauri also cautioned, "Safe treatment with stents requires that patients are also able to take important medications like aspirin and other medicines that prevent clotting such as clopipdogrel, and so the choice of treatment still requires careful consideration of each individual patient’s condition.
Principle investigator of the study and professor of Health Care Policy at HMS, Sharon-Lise Normand added, "Through an effort headed by the Division of Health Care Quality at the Massachusetts Department of Public Health we were able to use clinical data collected from every hospital in the state that treats patients with stents to assess safety of the drug-eluting stents."
The research was part of a program that the Massachusetts Department of Public Health established in 2002 to examine the quality of cardiac care in Massachusetts hospitals. Dr. Paul Dreyer, Director of the Department's Bureau of Health Care Safety and Quality which oversees the program, said "The potential impact of this research on public health is an excellent example of the benefits of collaboration between government and academic institutions." Harvard Medical School serves as the cardiac data and research coordinating center for the Department's program.
The research was funded by the Massachusetts Department of Public Health.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
Harvard Medical School http://hms.harvard.edu has more than 7,500 full-time faculty working in 11 academic departments located at the School's Boston campus or in one of 47 hospital-based clinical departments at 18 Harvard-affiliated teaching hospitals and research institutes. Those affiliates include Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Cambridge Health Alliance, Children's Hospital Boston, Dana-Farber Cancer Institute, Forsyth Institute, Harvard Pilgrim Health Care, Hebrew SeniorLife, Joslin Diabetes Center, Judge Baker Children's Center, Immune Disease Institute, Massachusetts Eye and Ear Infirmary, Massachusetts General Hospital, McLean Hospital, Mount Auburn Hospital, Schepens Eye Research Institute, Spaulding Rehabilitation Hospital, and VA Boston Healthcare System.
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Press Release - Sep 21, 2008
Six New Genetic Indicators for Rheumatoid Arthritis
Boston, MA – Researchers from Brigham and Women’s Hospital (BWH) and colleagues have uncovered specific locations on chromosomes (loci) linked to rheumatoid arthritis (RA), a progressive autoimmune disease that attacks the joints and other organs. Variations in the genetic sequence at these locations imply a risk of developing RA. These findings appear in the September 14, 2008, advance on-line issue of Nature Genetics.
A painful and sometimes disabling disease, RA afflicts up to one percent of the global population and an average of two million people in the U.S. “Learning of new loci linked to RA can help researchers determine how variations there effect the immune system, as well as fuel research for new treatments,” said Robert Plenge, MD, of the Division of Rheumatology, Immunology and Allergy at BWH.
The discovery of a particular location, CD40- a gene linked to mediating immune and inflammatory responses- is important because CD40 has been a target for therapy in the past. By confirming that genetic variations at this location implies risk of developing RA, researchers have provided a basis for continuing investigation of CD40 to help determine therapy for the disease.
In addition to the six loci researchers found, seven other loci have previously been shown to imply risk for RA if variations occur. Plenge said, “This study supports the idea that there are many more locations on chromosomes that are linked with determining risk of developing this disease.” He emphasizes, “Each discovery of a new locus is like finding another puzzle piece that helps us put together a better understanding of RA."
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Sep 18, 2008
BWH Neurosurgeon Named to National Neurology Advisory Council
Robert M. Friedlander, MD, vice chairman of the Department of Neurosurgery at Brigham and Women's Hospital (BWH) and associate professor in neurosurgery at Harvard Medical School, has been appointed to the National Advisory Neurological Disorders and Stroke Council, the major advisory panel for the National Institute of Neurological Disorders and Stroke (NINDS).
The NINDS, a component of the National Institutes of Health (NIH), is the nation’s primary supporter of basic, translational, and clinical research on the brain and nervous system. The council meets three times each year to review applications from scientists seeking financial support for biomedical research and research training on disorders of the brain and nervous system. Members also advise the institute on research program planning and priorities.
Dr. Friedlander’s clinical specialties include aneurysms and vascular malformations, brain tumors, carotid disease, cerebrovascular disease, Chiari malformation, microvascular decompression, and radiosurgery. His research focuses on mechanisms of apoptosis, or programmed cell death. He and his team are investigating ways to stop or slow the progression of cell death in Huntington’s disease, ALS, and stroke. He was the first to demonstrate the functional role of apoptotic pathways in a number of neurologic diseases. He and his team have reported success with using pharmacological interventions to reduce apoptosis in mouse models of neurological disease. He is a member of numerous professional societies and is widely published in his field. Dr. Friedlander is also an associate neurosurgeon at Children’s Hospital Boston and on the consulting staff at Dana Farber Cancer Institute.
Dr. Friedlander formally joined the 18-member council, composed of physicians, scientists, and representatives of the public, at the council’s September 18 meeting, and will serve through July 2012.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Sep 4, 2008
BWH Researchers Identify New Genetic Pathway for Inflammatory Bowel Disease
Future therapeutics can target specific risk factors for Crohn’s disease and ulcerative colitis
Boston, MA – Researchers from Brigham and Women’s Hospital (BWH), Harvard’s School of Public Health and Medical School and colleagues in Europe have found a new genetic pathway for the development of both of the major forms of inflammatory bowel disease (IBD); Crohn’s disease and ulcerative colitis. Alterations in the gene XBP1, (X box binding protein 1) which is involved in regulating cellular stress pathways, has been identified as a major risk factor for the development of these two IBDs and the researchers point to the epithelial cell as the cell type responsible for initiating IBD as a result of the genetic alterations. The findings appear in the September 5, 2008 issue of the Journal Cell.
It has long been suspected that the epithelium may play a critical role in the development of ulcerative colitis and Crohn’s disease. The epithelium that lines the inside surfaces of the intestine is the first set of cells to contact the environment and serves as the primary functional barrier to the outside world. This epithelium is strategically placed between the two major ingredients involved in the development of IBD, the largest concentrations of bacteria and immune cells in the human body.
To determine the role of XBP1 in the intestinal epithelium, the researchers developed mice in which that gene was deleted. The mice developed an IBD-like intestinal inflammation through a mechanism that involved an inability to regulate intestinal bacteria, together with a hypersensitivity of the epithelium to the products of the bacteria, culminating in spontaneous intestinal inflammation. To determine if XBP1 might be a genetic risk factor in the development of the human conditions, the researchers performed genetic analysis on nearly 5,000 IBD patients and controls which involved genetic sequencing through the XBP1 gene of 1,200 patients and controls and found that there was an association with both forms of IBD. They also found unique genetic alterations that were likely to be functional risk factors.
“The findings are very exciting and paint the first coherent picture of how a genetic encoded risk factor can emerge as inflammatory bowel disease,” said Richard Blumberg MD, senior author of the study and Chief of the Division of Gastroenterology, Hepatology and Endoscopy at BWH. He continued, “The therapeutic implications are huge because the findings allow us, for the first time, to rationally target a factor that we know is a risk factor for developing IBD.” Co-senior author Laurie Glimcher the Irene Heinz Given Professor of Immunology at Harvard School of Public Health comments, “We had no idea when we first discovered XBP1 that it would turn out to be such a key factor in a human disease.”
The research was funded by the Crohn’s and Colitis Foundation of America, the National Institutes of Health, the Ellison Medical Foundation, the DFG/German Ministry of Science Excellence Cluster, the Austrian Science Fund and the Max Kade Foundation.
The research team was comprised of: Arthur Kaser, Brigham and Women’s Hospital; Ann-Hwee Lee, Harvard School of Public Health; Andre Franke, Christian-Albrechts University, Kiel, Germany; Jonathan Glickman, Brigham and Women’s Hospital; Sebastian Zeissig, Brigham and Women’s/Harvard Medical School; Herbert Tilg, Innsbruck Medical University, Austria; Edward Nieuwenhuis, Sophia Children’s Hospital, Rotterdam, The Netherlands; Darren Higgins, Harvard Medical School; Stefan Schreiber, Christian-Albrechts University, Kiel, Germany; Laurie Glimcher, Harvard’s School of Public Health and Medical School and Brigham and Women’s Hospital; Richard Blumberg, Brigham and Women’s Hospital and Harvard Medical School.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Sep 3, 2008
Health Care Fraud Cases in the U.S. Resulted in $9.3 Billion in Damages in the Last Decade
Researchers analyzed outcomes and characteristics of federal cases exposed by whistleblowers between 1996 and 2005
BOSTON, MA – Health care fraud is widely thought to be pervasive, and now, for the first time, researchers at Brigham and Women’s Hospital (BWH) have chronicled the characteristics and financial impact of recent health care fraud cases. Their work, published in the September 2, 2008 issue of the Annals of Internal Medicine, provides important insights into where health care fraud is found most frequently and the whistleblowers who enact most of the legal action.
“With health care costs continuously rising and straining government budgets, the efforts of prosecutors to identify and address health care fraud where it exists are becoming increasingly important,” said Aaron S. Kesselheim, MD, JD, MPH, an Instructor in Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics at BWH and lead author of the study. “This study provides the results from a systematic evaluation of fraud cases.”
Kesselheim and his co-author, David M. Studdert, LLB, ScD, of the University of Melbourne, Victoria, Australia, analyzed all 379 federal health care fraud cases resolved between 1996 and 2005 that were initiated by whistleblowers who have inside knowledge of the alleged fraud—so-called qui tam actions. Whistleblowers, who were most commonly executives or physicians and were more likely to be internal employees, now account for nearly all health care fraud legal actions and can share in the proceeds. Researchers found that the 379 cases led to $9.3 billion in financial recoveries, with $7.2 billion returned to the federal government and $861 million to state governments. On average, whistleblowers recovered $3.6 million per case, with approximately $1 billion returned to whistleblowers overall.
“Fraud prosecutions have been successful in bringing back an extremely large amount of health care dollars to the government, and whistleblowers are integral in that process. The concern is that there is still more unrecognized fraud ongoing in the system. It is important to understand features and trends in health care fraud prosecution so that we may identify effective enforcement strategies and other policy interventions to bring fraud under control,” Kesselheim said.
Researchers also note that although there has been a decline in the frequency of cases since 2002, there has been a steady increase in the average value of the sum recovered, which is attributable to a number of recent high-value cases against pharmaceutical manufacturer defendants. Although pharmaceutical manufacturers accounted for only 4 percent of the defendants, they led to nearly 40 percent of the money recovered. The profile of defendants has also changed over time. At the beginning of the study, laboratory service providers, hospitals, medical equipment companies, and physician groups were the most common defendants. But while these types of defendants decreased over time, by the end of the study, billing organizations and pharmaceutical manufacturers accounted for 25 percent of the cases. Among the 85 percent of cases that were classified, Kesselheim and Studdert also discovered that billing fraud was the most common type of fraud, specifically billing for unnecessary services, falsifying documents, and billing for services not provided.
“Future research will focus on the trends in the types of defendants and the types of cases as well as the whistleblowers themselves,” said Kesselheim. “We are interested in exploring how the qui tam approach for targeting health care fraud may be best utilized to play a role in controlling inefficient health care spending.”
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org
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Press Release - Sep 2, 2008
Common Over-the-counter Drug Could Pose Serious Risk for Some
Daily ibuprofen use may increase cardiovascular risk for arthritis patients
Boston, MA - In 2004, rofecoxib, better known by its brand name, Vioxx, was withdrawn from the market due to concerns about possible increased risk of heart attack and stroke. Not long after, valdecoxib, marketed as Bextra, was removed for the same reason. Since then, anxieties surrounding the cardiovascular safety of nonselective NSAIDs (nonsteroidal antiinflammatory drugs), as well as other selective coxibs (Cox 2 inhibitors), have escalated among arthritis patients and the doctors who treat them. Now, researchers from Brigham and Women's Hospital (BWH) have performed one of a few randomized controlled trials to measure the cardiovascular risks for the millions of daily users of all Cox 2s and NASIDs, including over-the-counter pain relievers.
How dangerous are Cox 2s and NSAIDs? Do all users face a dramatically increased risk of suffering a crippling or fatal cardiovascular event? For answers, Daniel H. Solomon, MD, a researcher in the Rheumatology, Immunology & Allergy Department at BWH and lead author of the study and his colleagues examined cardiovascular events in specific subgroups of patients prescribed Cox 2s or NSAIDs. Featured in the August issue of Arthritis Care & Research, their findings support the cardiovascular safety of taking most NSAIDs and Cox 2s for most arthritis patients. Certain patients, however, may be at an increased risk when using some medications. This study also raises a red flag for all patients who routinely take ibuprofen. Ibuprofen, the analgesic agent in Advil and Motrin, and the now-banned rofecoxib were the only drugs consistently associated with an increased risk for cardiovascular events across patient subgroups.
The patient subgroups were drawn from two databases of Medicare recipients enrolled in drug benefit programs. Patients covered by Pennsylvania’s Pharmaceutical Assistance Contract for the Elderly (PACE) were the primary subjects, with participants in New Jersey’s Pharmaceutical Assistance for the Aged and Disabled (PAAD) designated as a secondary cohort. Researchers chose 1999 to 2004, prior to the restrictions on coxib use, for their study period.
In the primary group, researchers identified 76,082 new users of Cox 2s, either rofecoxib, valdecoxib, or celecoxib, also known as Celebrex, and 53, 014 new users of nonselective NSAIDs, including prescription diclofenac, naproxen, ibuprofen, and a composite of all other available oral NSAIDs, excluding aspirin. For comparison, 46, 558 patients receiving medication for thyroid problems or glaucoma were identified as nonusers. The only major difference between Cox 2s and NSAID users and nonusers was that nonusers were less likely to have been diagnosed with arthritis. The mean age of the study population was 80 and nearly 85 percent were white women. Defined by patient characteristics, subgroups included age and sex; prior myocardial infarction (MI), congestive heart failure (CHF), stroke, or any cardiovascular (CVD) event; hypertension, diabetes, or any CVD risk factor; chronic renal disease; rheumatoid arthritis (RA), chronic obstructive pulmonary disease (COPD); and use of a statin or angiotensin.
For each subgroup, researchers assessed the increased cardiovascular risk associated with using specific Cox 2s and/or nonselective NSAIDs. They calculated not only the relative risk (RR) for MI, CHF, stroke, or cardiovascular death, but also the attributable proportion (AP) of risk due to the biological interaction between the specific patient characteristic and the individual drug. As a whole, the group experienced 7,262 CVD events during the 64,136 person-years of followup. The incidence rates varied substantially across the exposure groups, with rofecoxib users experiencing the highest rates, naproxen users experiencing the lowest rates, and nonusers midway between the two. When calculating the AP, researchers found 7 characteristics linked to an increased risk of CVD events among Cox 2s and NSAID users: age 80 years and older, hypertension, prior MI, prior CVD, RA, chronic renal disease, and COPD. When comparing the incidence rates by agent, rofecoxib and ibuprofen users experienced more CVD events in every subgroup. For example, among patients with a prior MI, rofecoxib users suffered 9.4 more CVD events and ibuprofen users 11.4 more events per 100 person-years compared with nonusers.
Solomon acknowledges the study's limitations. For one, the subjects were overwhelmingly frail, elderly patients. For another, researchers had no information on aspirin use, smoking history, body mass index, or other potential confounders. For still another, possible effects of drug dosage differences were not considered. Despite these limitations, the results have potential clinical relevance. “Our findings suggest that rofecoxib and ibuprofen are the only agents consistently associated with an increased risk for CVD events among specific patient subgroups,” Dr. Solomon notes. “The fact that we did not observe a similar concentration in risk among subgroups of patients using many of the other agents may be of even greater relevance. These results should bolster physicians’ and patients’ confidence that most Cox 2s and nonselective NSAIDs are not associated with an elevated risk of CVD events in many patient subgroups using typical doses.”
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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Press Release - Aug 25, 2008
Drug Resistant Tuberculosis Is Treatable
Research documents successful outcomes for patients with extensively drug resistant tuberculosis
Boston, MA – Rates of extensively drug-resistant tuberculosis (XDR-TB) are growing rapidly throughout the world, and curtailing the disease is a major World Health Organization (WHO) priority. Now, researchers from Brigham and Women’s Hospital (BWH) have shown successful treatment outcomes for patients with XDR-TB in Tomsk, Russia. These findings are published in the August 25, 2008 online issue of The Lancet.
"While early studies suggested that XDR-TB is untreatable, our report indicates that while it may be difficult, it is possible to treat these patients through the use of aggressive regimens," said Salmaan Keshavjee, MD, a researcher in the Division of Global Health Equity at BWH and lead author of the report. "A cure rate of 48.3 percent is promising in a disease that has been touted as untreatable."
Researchers report on the treatment approaches and outcomes of 608 patients with multi-drug resistant tuberculosis who were treated between September 2000 and November 2004 to determine the frequency of favorable outcomes and document clinical characteristics. Patients were categorized into two groups, those with XDR-TB and those with non-extensively drug-resistant (non-XDR) TB. Of the 608 patients, four percent or 29 patients were diagnosed with XDR-TB.
Researchers report:
* Drug resistant strains of TB are treatable. Of the 608 patients, 48.3 percent of patients with XDR-TB and 66.7 percent of patients with non-XDR-TB had treatment cure or completion.
* Prior, inadequate treatment of non-XDR-TB increases the chance for a patient to develop XDR-TB. Inadequate treatment includes an incorrect combination of medicines or inadequate duration of treatment.
* The frequency of adverse events did not differ in patients with XDR-TB as compared to patients with non-XDR-TB. This is the first report to provide information about the frequency of adverse events during a treatment course for XDR-TB specifically.
"Through aggressive management of XDR-TB cases, including by ensuring that patients are correctly diagnosed as early as possible and put on appropriate treatment for the correct length of time, it may be possible to slow the rise of XDR-TB deaths around the world and reduce further transmission of the most drug resistant strains of TB," said Keshavjee.
This research was funded by Bill & Melinda Gates Foundation, Eli Lilly Foundation, The Open Society Institute, Frank Hatch Fellowships in Global Health Equity at BWH, Infectious Disease Society of America, the Heiser Foundation, the United States National Institutes of Health, and the John D and Catherine T MacArthur Foundation.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org
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Press Release - Aug 14, 2008
New Research Highlights How and When Errors in Inpatient Medication Reconciliation Occur
Boston, MA – The Joint Commission made inpatient medication reconciliation a National Patient Safety Goal in 2005, focusing nationwide attention on the issue of errors in inpatient medication records as they move in and out of the hospital. According to a new study from researchers at Brigham and Women's Hospital (BWH) and Massachusetts General Hospital, inpatients experience an average of nearly one and a half potentially harmful errors in their medication record during a hospital stay. Unique from previous research, the study goes on to uncover the frequency of different kinds of errors, at what point during the process they most often occur, and factors that place a patient at risk for having these errors occur. These findings appear in the September 2008 issue of the Journal of General Internal Medicine.
Inpatient medication reconciliation is the process of identifying the most accurate list of all medications a patient is taking and using the list to provide correct medications for the patient. Until now, the attention has been on meeting this requirement without understanding where efforts should be focused. This study exposes the specific times during an inpatient visit when medication reconciliation errors most often occur. Seventy two percent of potentially harmful discrepancies are due to errors in taking patients’ medication history, while only twenty six percent occur while reconciling medication history with discharge orders. Also, the majority of discrepancies are due to the omission of medications, which account for more errors than incorrect reports of dosage, frequency, substitutions, and the addition of medications combined.
“This information can help guide hospitals in determining where to focus their efforts for addressing this problem,” said Jeffrey Schnipper, MD, MPH senior author and Hospitalist at BWH, who also notes that some hospitals are now assigning pharmacists to take inpatients’ medication histories at admission.
Though the majority of errors occur at the time of admission, the potential to cause harm generally occurs at discharge. At discharge patients can be sent home without necessary medications, with additional unnecessary medications, or on the wrong doses. “Medication discrepancies at discharge are especially dangerous because patients are no longer being monitored consistently and may not recognize signs of medication problems on their own,” Schnipper said.
Researchers also uncovered several predictors that can help professionals identify inpatients that are at higher risk for discrepancies in their medication records. Indicators of a higher risk inpatient include those with six or more medication changes during hospitalization; minimal understanding of preadmission medications; a caregiver providing medication information; thirteen or more outpatient visits during the previous year; an admission history taken by an intern; or four or more high-risk medications prescribed prior to admission.
“With patients today on more medications than in days past, the stakes are higher than ever before,” Schnipper says of reconciling medication. “Knowing when and where to look for discrepancies will help hospitals prevent errors that could cause harm to patients.”
The research was funded by internal support from Brigham and Women’s Hospital, Massachusetts General Hospital, and Partners Healthcare, and by an investigator-initiated grant from the Harvard Risk Management Foundation.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org
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Press Release - Aug 12, 2008
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