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Dr. Nicholas P.D. Smyth, a thoracic and cardiovascular surgeon and pioneer in pacemaker design, died of heart failure in November in Naples, Fla. He was 88.

As a clinical researcher, Dr. Smyth invented pacemakers and device components, many of which are still used today. One such invention was the atrial J-lead wire, which was designed specifically to stabilize the lead wire's position in the atrium. He was also the coinventor of the world's smallest nuclear pacemaker.

Together with Dr. Seymour Furman and Dr. Victor Parsonnet, he devised the three-position pacemaker code, an alphabetical code that describes a particular pacemaker's functions. The Intersociety Commission for Heart Disease Resources (ICHD) subsequently introduced the three-position ICHD Code based on the trio's original concept.

Dr. Smyth was born in Ireland, and received his undergraduate degree from University College Dublin in 1949. He moved to the United States and earned his medical degree from the University of Michigan in 1954, then served from 1955 to 1957 in the surgery department of the Army hospital at Fort Chaffee, Ark.

After his discharge from the military, he moved to Washington, where he completed his residency in thoracic surgery at George Washington University Medical School. He remained on the university's faculty for almost 40 years, during which time he was also a teacher and surgeon at other institutions in the area. He was a founding member of the Heart Rhythm Society.

After his retirement, Dr. Smyth wrote a medical mystery novel, “Heartbreak.” A second novel is due to be published.

Cardiologists on the Move

Dr. Sumeet S. Chugh, an expert in heart rhythm abnormalities, has been named associate director of the Cedars-Sinai Heart Institute in Los Angeles, where he will also serve as the director of clinical electrophysiology.

Dr. Chugh's expertise focuses on diagnostic procedures, the use of pacemakers, defibrillators, biventricular devices, and radiofrequency ablation procedures to correct rhythm problems. He previously directed the cardiac arrhythmia center at Oregon Health and Science University in Portland, where he was also section chief of clinical cardiac electrophysiology and associate professor of medicine.

In 2002, Dr. Chugh began the Oregon Sudden Unexpected Death Study, a population study of sudden cardiac arrest in patients at 16 hospitals serving the state's Multnomah County. The studies provided a comprehensive assessment of sudden cardiac arrest patients, leading to a major shift in the way in which the condition is researched, and treated. Dr. Chugh is now helping design and launch similar community-centered research studies overseas and leads the panel that is charged by the World Health Organization with performing a worldwide assessment of heart rhythm disorders for the Global Burden of Disease Study.

Dr. Chugh received his medical degree from Government Medical College, Patiala, in Punjab, India, then served as a research associate at Tufts New England Medical Center in Boston from 1989 to 1991. He began his internal medicine residency at Tufts Newton Wellesley Hospital, also in Boston, and completed it at Hennepin County Medical Center in Minneapolis. He remained in Minnesota, where he completed fellowships in cardiology at the University of Minnesota in Minneapolis and in clinical cardiac electrophysiology at the Mayo Clinic in Rochester, Minn. Dr. Chugh joined the faculty of Oregon Health and Science in 1999. He held several academic positions there before accepting his new responsibilities at Cedars-Sinai, where he will join Dr. Eduardo Marban, a leading cardiologist and heart researcher, who was appointed director of the institute in 2007 (CARDIOLOGY NEWS, June 2007, p.31).

Dr. Douglas B. Sawyer, Ph.D., has been named physician-in-chief of the Vanderbilt Heart and Vascular Institute in Nashville, Tenn., and chief of the division of cardiovascular medicine in the department of medicine.

He has served as interim chief of the cardiovascular division since May last year and is also the Lisa R. Jacobson Associate Professor of Medicine.

As a specialist in myocyte biology, Dr. Sawyer's research focus has included cell biology and signalling of cardiac myocytes, the mechanisms of congestive heart failure, myocardial remodeling, and chemotherapeutic cardiotoxicity, and development of new therapeutic strategies for cardiovascular disease.

Dr. Sawyer received his undergraduate, doctorate, and medical degrees from Cornell University, New York, and trained in internal medicine and cardiology at Brigham and Women's Hospital in Boston. He was an assistant professor of medicine and molecular medicine in the cardiology section of Boston University Medical Center until 2006, when he moved to Vanderbilt as the Bailey Associate Professor of Cardiology.

DR. CHUGH

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Obituary

Dr. Nicholas P.D. Smyth, a thoracic and cardiovascular surgeon and pioneer in pacemaker design, died of heart failure in November in Naples, Fla. He was 88.

As a clinical researcher, Dr. Smyth invented pacemakers and device components, many of which are still used today. One such invention was the atrial J-lead wire, which was designed specifically to stabilize the lead wire's position in the atrium. He was also the coinventor of the world's smallest nuclear pacemaker.

Together with Dr. Seymour Furman and Dr. Victor Parsonnet, he devised the three-position pacemaker code, an alphabetical code that describes a particular pacemaker's functions. The Intersociety Commission for Heart Disease Resources (ICHD) subsequently introduced the three-position ICHD Code based on the trio's original concept.

Dr. Smyth was born in Ireland, and received his undergraduate degree from University College Dublin in 1949. He moved to the United States and earned his medical degree from the University of Michigan in 1954, then served from 1955 to 1957 in the surgery department of the Army hospital at Fort Chaffee, Ark.

After his discharge from the military, he moved to Washington, where he completed his residency in thoracic surgery at George Washington University Medical School. He remained on the university's faculty for almost 40 years, during which time he was also a teacher and surgeon at other institutions in the area. He was a founding member of the Heart Rhythm Society.

After his retirement, Dr. Smyth wrote a medical mystery novel, “Heartbreak.” A second novel is due to be published.

Cardiologists on the Move

Dr. Sumeet S. Chugh, an expert in heart rhythm abnormalities, has been named associate director of the Cedars-Sinai Heart Institute in Los Angeles, where he will also serve as the director of clinical electrophysiology.

Dr. Chugh's expertise focuses on diagnostic procedures, the use of pacemakers, defibrillators, biventricular devices, and radiofrequency ablation procedures to correct rhythm problems. He previously directed the cardiac arrhythmia center at Oregon Health and Science University in Portland, where he was also section chief of clinical cardiac electrophysiology and associate professor of medicine.

In 2002, Dr. Chugh began the Oregon Sudden Unexpected Death Study, a population study of sudden cardiac arrest in patients at 16 hospitals serving the state's Multnomah County. The studies provided a comprehensive assessment of sudden cardiac arrest patients, leading to a major shift in the way in which the condition is researched, and treated. Dr. Chugh is now helping design and launch similar community-centered research studies overseas and leads the panel that is charged by the World Health Organization with performing a worldwide assessment of heart rhythm disorders for the Global Burden of Disease Study.

Dr. Chugh received his medical degree from Government Medical College, Patiala, in Punjab, India, then served as a research associate at Tufts New England Medical Center in Boston from 1989 to 1991. He began his internal medicine residency at Tufts Newton Wellesley Hospital, also in Boston, and completed it at Hennepin County Medical Center in Minneapolis. He remained in Minnesota, where he completed fellowships in cardiology at the University of Minnesota in Minneapolis and in clinical cardiac electrophysiology at the Mayo Clinic in Rochester, Minn. Dr. Chugh joined the faculty of Oregon Health and Science in 1999. He held several academic positions there before accepting his new responsibilities at Cedars-Sinai, where he will join Dr. Eduardo Marban, a leading cardiologist and heart researcher, who was appointed director of the institute in 2007 (CARDIOLOGY NEWS, June 2007, p.31).

Dr. Douglas B. Sawyer, Ph.D., has been named physician-in-chief of the Vanderbilt Heart and Vascular Institute in Nashville, Tenn., and chief of the division of cardiovascular medicine in the department of medicine.

He has served as interim chief of the cardiovascular division since May last year and is also the Lisa R. Jacobson Associate Professor of Medicine.

As a specialist in myocyte biology, Dr. Sawyer's research focus has included cell biology and signalling of cardiac myocytes, the mechanisms of congestive heart failure, myocardial remodeling, and chemotherapeutic cardiotoxicity, and development of new therapeutic strategies for cardiovascular disease.

Dr. Sawyer received his undergraduate, doctorate, and medical degrees from Cornell University, New York, and trained in internal medicine and cardiology at Brigham and Women's Hospital in Boston. He was an assistant professor of medicine and molecular medicine in the cardiology section of Boston University Medical Center until 2006, when he moved to Vanderbilt as the Bailey Associate Professor of Cardiology.

DR. CHUGH

Obituary

Dr. Nicholas P.D. Smyth, a thoracic and cardiovascular surgeon and pioneer in pacemaker design, died of heart failure in November in Naples, Fla. He was 88.

As a clinical researcher, Dr. Smyth invented pacemakers and device components, many of which are still used today. One such invention was the atrial J-lead wire, which was designed specifically to stabilize the lead wire's position in the atrium. He was also the coinventor of the world's smallest nuclear pacemaker.

Together with Dr. Seymour Furman and Dr. Victor Parsonnet, he devised the three-position pacemaker code, an alphabetical code that describes a particular pacemaker's functions. The Intersociety Commission for Heart Disease Resources (ICHD) subsequently introduced the three-position ICHD Code based on the trio's original concept.

Dr. Smyth was born in Ireland, and received his undergraduate degree from University College Dublin in 1949. He moved to the United States and earned his medical degree from the University of Michigan in 1954, then served from 1955 to 1957 in the surgery department of the Army hospital at Fort Chaffee, Ark.

After his discharge from the military, he moved to Washington, where he completed his residency in thoracic surgery at George Washington University Medical School. He remained on the university's faculty for almost 40 years, during which time he was also a teacher and surgeon at other institutions in the area. He was a founding member of the Heart Rhythm Society.

After his retirement, Dr. Smyth wrote a medical mystery novel, “Heartbreak.” A second novel is due to be published.

Cardiologists on the Move

Dr. Sumeet S. Chugh, an expert in heart rhythm abnormalities, has been named associate director of the Cedars-Sinai Heart Institute in Los Angeles, where he will also serve as the director of clinical electrophysiology.

Dr. Chugh's expertise focuses on diagnostic procedures, the use of pacemakers, defibrillators, biventricular devices, and radiofrequency ablation procedures to correct rhythm problems. He previously directed the cardiac arrhythmia center at Oregon Health and Science University in Portland, where he was also section chief of clinical cardiac electrophysiology and associate professor of medicine.

In 2002, Dr. Chugh began the Oregon Sudden Unexpected Death Study, a population study of sudden cardiac arrest in patients at 16 hospitals serving the state's Multnomah County. The studies provided a comprehensive assessment of sudden cardiac arrest patients, leading to a major shift in the way in which the condition is researched, and treated. Dr. Chugh is now helping design and launch similar community-centered research studies overseas and leads the panel that is charged by the World Health Organization with performing a worldwide assessment of heart rhythm disorders for the Global Burden of Disease Study.

Dr. Chugh received his medical degree from Government Medical College, Patiala, in Punjab, India, then served as a research associate at Tufts New England Medical Center in Boston from 1989 to 1991. He began his internal medicine residency at Tufts Newton Wellesley Hospital, also in Boston, and completed it at Hennepin County Medical Center in Minneapolis. He remained in Minnesota, where he completed fellowships in cardiology at the University of Minnesota in Minneapolis and in clinical cardiac electrophysiology at the Mayo Clinic in Rochester, Minn. Dr. Chugh joined the faculty of Oregon Health and Science in 1999. He held several academic positions there before accepting his new responsibilities at Cedars-Sinai, where he will join Dr. Eduardo Marban, a leading cardiologist and heart researcher, who was appointed director of the institute in 2007 (CARDIOLOGY NEWS, June 2007, p.31).

Dr. Douglas B. Sawyer, Ph.D., has been named physician-in-chief of the Vanderbilt Heart and Vascular Institute in Nashville, Tenn., and chief of the division of cardiovascular medicine in the department of medicine.

He has served as interim chief of the cardiovascular division since May last year and is also the Lisa R. Jacobson Associate Professor of Medicine.

As a specialist in myocyte biology, Dr. Sawyer's research focus has included cell biology and signalling of cardiac myocytes, the mechanisms of congestive heart failure, myocardial remodeling, and chemotherapeutic cardiotoxicity, and development of new therapeutic strategies for cardiovascular disease.

Dr. Sawyer received his undergraduate, doctorate, and medical degrees from Cornell University, New York, and trained in internal medicine and cardiology at Brigham and Women's Hospital in Boston. He was an assistant professor of medicine and molecular medicine in the cardiology section of Boston University Medical Center until 2006, when he moved to Vanderbilt as the Bailey Associate Professor of Cardiology.

DR. CHUGH

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Obituaries

Although Dr. Kantrowitz enjoyed the distinction of performing that first operation, most of his 60 years of practice and research were focused on developing devices that assisted heart function, rather than replacing weak and malfunctioning hearts. His historic transplant, on Dec. 6, 1967, followed the world's first, by the South African surgeon Christiaan Barnard, by 3 days, and was the culmination of almost 4 years of transplants in dogs.

From early on in his career, Dr. Kantrowitz had collaborated with the late Dr. Michael DeBakey and others, including his wife Jean, in devising new methods for treating and sustaining gravely ill heart patients. These included the development of the left-ventricular assist device, the intra-aortic balloon pump for reducing strain on the heart; and an early version of the implantable pacemaker.

Dr. Kantrowitz studied mathematics at New York University before attending the Long Island College of Medicine (now State University of New York, Brooklyn). He graduated in 1943 and served for 3 years as a surgeon in the U.S. army medical corps. After specializing in cardiology, he held various positions at Montefiore Hospital (now Montefiore Medical Center) in New York.

In 1955, he became director of cardiovascular surgery at New York's Maimonides Hospital, where he and his fellow researchers invented an electronically controlled heart-lung machine and a diaphragm booster heart that functioned as a second heart. He left Maimonides in 1970, however, after facing questions about his research, and moved to Sinai Hospital in Detroit, where he was an attending surgeon and chairman of the department of surgery. He continued experimenting with transplants, the balloon pump, and partial mechanical hearts.

In 1983 he and his wife cofounded L.VAD Technology, research and development company in Detroit that specialized in cardiovascular devices. The couple was still working on new devices until the end of his life. Shortly before his death, Dr. Kantrowitz received approval from the Food and Drug Administration to proceed with a clinical trial for a new balloon-pump variant.

Dr. Mark Silverman, a consultative cardiologist, teacher, and medical historian, died of a heart attack at Piedmont Hospital in Atlanta, where he had founded the Fuqua Heart Center. He was 69 years of age.

At the time of his death, he was emeritus professor of medicine (cardiology) at Emory University, also in Atlanta, chief of cardiology at the heart center, and director of its noninvasive (electrocardiology, echo, and stress testing) laboratories.

Dr. Silverman was known for his lively lectures, in which he would sometimes dress in period outfits: When teaching about the electrocardiogram, for example, he would dress and speak as its Dutch inventor, the 1924 Nobel laureate, Dr. Willem Einthoven.

Dr. Silverman published a textbook on clinical skills in primary care, numerous articles, and chapters in books on medical history, a book that explored the relationship between some heart conditions and abnormalities of the hand.

Dr. Silverman received his medical degree from the University of Chicago, after which he returned to his alma mater, Ohio State University, Columbus, for his medical residency. He worked with Dr. Hurst from 1966 to 1968 and, after serving in the U.S. Air Force at David Grant Medical Center at Travis Air Force Base, California, he returned to Atlanta in 1970 as the Emory-Piedmont Professor of Medicine and established a cardiology program at Piedmont Hospital.

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Obituaries

Although Dr. Kantrowitz enjoyed the distinction of performing that first operation, most of his 60 years of practice and research were focused on developing devices that assisted heart function, rather than replacing weak and malfunctioning hearts. His historic transplant, on Dec. 6, 1967, followed the world's first, by the South African surgeon Christiaan Barnard, by 3 days, and was the culmination of almost 4 years of transplants in dogs.

From early on in his career, Dr. Kantrowitz had collaborated with the late Dr. Michael DeBakey and others, including his wife Jean, in devising new methods for treating and sustaining gravely ill heart patients. These included the development of the left-ventricular assist device, the intra-aortic balloon pump for reducing strain on the heart; and an early version of the implantable pacemaker.

Dr. Kantrowitz studied mathematics at New York University before attending the Long Island College of Medicine (now State University of New York, Brooklyn). He graduated in 1943 and served for 3 years as a surgeon in the U.S. army medical corps. After specializing in cardiology, he held various positions at Montefiore Hospital (now Montefiore Medical Center) in New York.

In 1955, he became director of cardiovascular surgery at New York's Maimonides Hospital, where he and his fellow researchers invented an electronically controlled heart-lung machine and a diaphragm booster heart that functioned as a second heart. He left Maimonides in 1970, however, after facing questions about his research, and moved to Sinai Hospital in Detroit, where he was an attending surgeon and chairman of the department of surgery. He continued experimenting with transplants, the balloon pump, and partial mechanical hearts.

In 1983 he and his wife cofounded L.VAD Technology, research and development company in Detroit that specialized in cardiovascular devices. The couple was still working on new devices until the end of his life. Shortly before his death, Dr. Kantrowitz received approval from the Food and Drug Administration to proceed with a clinical trial for a new balloon-pump variant.

Dr. Mark Silverman, a consultative cardiologist, teacher, and medical historian, died of a heart attack at Piedmont Hospital in Atlanta, where he had founded the Fuqua Heart Center. He was 69 years of age.

At the time of his death, he was emeritus professor of medicine (cardiology) at Emory University, also in Atlanta, chief of cardiology at the heart center, and director of its noninvasive (electrocardiology, echo, and stress testing) laboratories.

Dr. Silverman was known for his lively lectures, in which he would sometimes dress in period outfits: When teaching about the electrocardiogram, for example, he would dress and speak as its Dutch inventor, the 1924 Nobel laureate, Dr. Willem Einthoven.

Dr. Silverman published a textbook on clinical skills in primary care, numerous articles, and chapters in books on medical history, a book that explored the relationship between some heart conditions and abnormalities of the hand.

Dr. Silverman received his medical degree from the University of Chicago, after which he returned to his alma mater, Ohio State University, Columbus, for his medical residency. He worked with Dr. Hurst from 1966 to 1968 and, after serving in the U.S. Air Force at David Grant Medical Center at Travis Air Force Base, California, he returned to Atlanta in 1970 as the Emory-Piedmont Professor of Medicine and established a cardiology program at Piedmont Hospital.

Obituaries

Although Dr. Kantrowitz enjoyed the distinction of performing that first operation, most of his 60 years of practice and research were focused on developing devices that assisted heart function, rather than replacing weak and malfunctioning hearts. His historic transplant, on Dec. 6, 1967, followed the world's first, by the South African surgeon Christiaan Barnard, by 3 days, and was the culmination of almost 4 years of transplants in dogs.

From early on in his career, Dr. Kantrowitz had collaborated with the late Dr. Michael DeBakey and others, including his wife Jean, in devising new methods for treating and sustaining gravely ill heart patients. These included the development of the left-ventricular assist device, the intra-aortic balloon pump for reducing strain on the heart; and an early version of the implantable pacemaker.

Dr. Kantrowitz studied mathematics at New York University before attending the Long Island College of Medicine (now State University of New York, Brooklyn). He graduated in 1943 and served for 3 years as a surgeon in the U.S. army medical corps. After specializing in cardiology, he held various positions at Montefiore Hospital (now Montefiore Medical Center) in New York.

In 1955, he became director of cardiovascular surgery at New York's Maimonides Hospital, where he and his fellow researchers invented an electronically controlled heart-lung machine and a diaphragm booster heart that functioned as a second heart. He left Maimonides in 1970, however, after facing questions about his research, and moved to Sinai Hospital in Detroit, where he was an attending surgeon and chairman of the department of surgery. He continued experimenting with transplants, the balloon pump, and partial mechanical hearts.

In 1983 he and his wife cofounded L.VAD Technology, research and development company in Detroit that specialized in cardiovascular devices. The couple was still working on new devices until the end of his life. Shortly before his death, Dr. Kantrowitz received approval from the Food and Drug Administration to proceed with a clinical trial for a new balloon-pump variant.

Dr. Mark Silverman, a consultative cardiologist, teacher, and medical historian, died of a heart attack at Piedmont Hospital in Atlanta, where he had founded the Fuqua Heart Center. He was 69 years of age.

At the time of his death, he was emeritus professor of medicine (cardiology) at Emory University, also in Atlanta, chief of cardiology at the heart center, and director of its noninvasive (electrocardiology, echo, and stress testing) laboratories.

Dr. Silverman was known for his lively lectures, in which he would sometimes dress in period outfits: When teaching about the electrocardiogram, for example, he would dress and speak as its Dutch inventor, the 1924 Nobel laureate, Dr. Willem Einthoven.

Dr. Silverman published a textbook on clinical skills in primary care, numerous articles, and chapters in books on medical history, a book that explored the relationship between some heart conditions and abnormalities of the hand.

Dr. Silverman received his medical degree from the University of Chicago, after which he returned to his alma mater, Ohio State University, Columbus, for his medical residency. He worked with Dr. Hurst from 1966 to 1968 and, after serving in the U.S. Air Force at David Grant Medical Center at Travis Air Force Base, California, he returned to Atlanta in 1970 as the Emory-Piedmont Professor of Medicine and established a cardiology program at Piedmont Hospital.

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ED Visits by Elderly Increase

The number of emergency department visits among elderly persons could almost double from 6 million in 2003 to just under 12 million by 2013, according to an analysis using National Hospital Ambulatory Medical Care Survey data from 1993–2003. The overall rate of admission in those patients aged 65–74 years increased 34% during the study period (Ann. Emerg. Med. 2007 [doi:10. 1016/j.annemerg med. 2007.09. 011]). The visit rate for elderly blacks rose 90% during that time but did not increase significantly for whites or other races. Researchers used admission rate and number of medications administered (one, two, or three) to gauge the acuity of the visit and found the absolute admission rate increased as did the number of visits in which three or more medications were given, suggesting “older Americans are having more true emergencies, rather than using the ED for convenience.” Ignoring these trends will result in a “serious increase in the problem of ED crowding,” they warned.

Center Takes on Nursing Shortage

A new think tank will address the burgeoning nursing shortage and its impact on the quality of patient care. To achieve this goal, the Center to Champion Nursing in America will focus on increasing funding for nursing education, expanding nurse representation on hospital boards, and informing policy makers and the public about the profession. The shortage is projected to hit 1.1 million by 2020, according to a statement from the Robert Wood Johnson Foundation, which gave the AARP a grant for establishing the center. A study in 2005 by the foundation and Harvard School of Public Health, Boston, found that 60% of Americans considered a shortage of nurses a major factor in poor care in hospitals, two-thirds cited nurses' working conditions as reasons for poor-quality care, and 80% said nursing quality affected their choice of hospital. “If we are going to improve the quality of hospital and nursing care, we need to find ways to fill the pipeline,” said Dr. Risa Lavizzo-Mourey, RWJF president and CEO.

DEA Accused of Electronic Stalling

The Drug Enforcement Administration, which investigates and prosecutes crimes involving illicit use of controlled substances, has been criticized for stalling implementation of a national electronic prescribing system for controlled substances. Sen. Sheldon Whitehouse (D-RI), speaking at a Senate Judiciary Committee hearing on e-prescribing, cited the DEA's tardiness in developing regulations for such a system and its reluctance to commit to a deadline for completing the regulations as the main reasons. Currently, doctors write prescriptions for controlled substances but can prescribe noncontrolled substances electronically, but most doctors use a “pen-and-paper regime” for all prescriptions, said Sen. Whitehouse, who argued that e-prescribing for all medications could save as much as $20 billion a year. Joseph T. Rannazzisi, a deputy assistant administrator for the DEA, told the committee that the agency is concerned an electronic system would be susceptible to abuse.

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. Health, United States, 2007, is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. In 2005, 1 in 10 people between the ages of 18 and 64 years reported they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of costs. The report also found 30% of 18- to 24-year-olds were uninsured, and another 30% of that group did not have a usual source of medical care. In 45- to 64-year-olds, 10% did not have a usual source of care.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that it “suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the agency has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources, meaning that “American lives are at risk,” adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, the Jefferson Pilot Corp. Professor of Neurobiology and Genetics at Duke University, Durham, N.C.; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston.

 

 

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a Nov. 30 letter to reconsider its draft guidance, which he said was close to being finalized. “[It] … would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. “This und ercuts the prohibition on marketing of unapproved uses of drugs and devices.” He requested detailed information on development of the new policy.

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ED Visits by Elderly Increase

The number of emergency department visits among elderly persons could almost double from 6 million in 2003 to just under 12 million by 2013, according to an analysis using National Hospital Ambulatory Medical Care Survey data from 1993–2003. The overall rate of admission in those patients aged 65–74 years increased 34% during the study period (Ann. Emerg. Med. 2007 [doi:10. 1016/j.annemerg med. 2007.09. 011]). The visit rate for elderly blacks rose 90% during that time but did not increase significantly for whites or other races. Researchers used admission rate and number of medications administered (one, two, or three) to gauge the acuity of the visit and found the absolute admission rate increased as did the number of visits in which three or more medications were given, suggesting “older Americans are having more true emergencies, rather than using the ED for convenience.” Ignoring these trends will result in a “serious increase in the problem of ED crowding,” they warned.

Center Takes on Nursing Shortage

A new think tank will address the burgeoning nursing shortage and its impact on the quality of patient care. To achieve this goal, the Center to Champion Nursing in America will focus on increasing funding for nursing education, expanding nurse representation on hospital boards, and informing policy makers and the public about the profession. The shortage is projected to hit 1.1 million by 2020, according to a statement from the Robert Wood Johnson Foundation, which gave the AARP a grant for establishing the center. A study in 2005 by the foundation and Harvard School of Public Health, Boston, found that 60% of Americans considered a shortage of nurses a major factor in poor care in hospitals, two-thirds cited nurses' working conditions as reasons for poor-quality care, and 80% said nursing quality affected their choice of hospital. “If we are going to improve the quality of hospital and nursing care, we need to find ways to fill the pipeline,” said Dr. Risa Lavizzo-Mourey, RWJF president and CEO.

DEA Accused of Electronic Stalling

The Drug Enforcement Administration, which investigates and prosecutes crimes involving illicit use of controlled substances, has been criticized for stalling implementation of a national electronic prescribing system for controlled substances. Sen. Sheldon Whitehouse (D-RI), speaking at a Senate Judiciary Committee hearing on e-prescribing, cited the DEA's tardiness in developing regulations for such a system and its reluctance to commit to a deadline for completing the regulations as the main reasons. Currently, doctors write prescriptions for controlled substances but can prescribe noncontrolled substances electronically, but most doctors use a “pen-and-paper regime” for all prescriptions, said Sen. Whitehouse, who argued that e-prescribing for all medications could save as much as $20 billion a year. Joseph T. Rannazzisi, a deputy assistant administrator for the DEA, told the committee that the agency is concerned an electronic system would be susceptible to abuse.

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. Health, United States, 2007, is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. In 2005, 1 in 10 people between the ages of 18 and 64 years reported they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of costs. The report also found 30% of 18- to 24-year-olds were uninsured, and another 30% of that group did not have a usual source of medical care. In 45- to 64-year-olds, 10% did not have a usual source of care.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that it “suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the agency has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources, meaning that “American lives are at risk,” adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, the Jefferson Pilot Corp. Professor of Neurobiology and Genetics at Duke University, Durham, N.C.; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston.

 

 

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a Nov. 30 letter to reconsider its draft guidance, which he said was close to being finalized. “[It] … would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. “This und ercuts the prohibition on marketing of unapproved uses of drugs and devices.” He requested detailed information on development of the new policy.

ED Visits by Elderly Increase

The number of emergency department visits among elderly persons could almost double from 6 million in 2003 to just under 12 million by 2013, according to an analysis using National Hospital Ambulatory Medical Care Survey data from 1993–2003. The overall rate of admission in those patients aged 65–74 years increased 34% during the study period (Ann. Emerg. Med. 2007 [doi:10. 1016/j.annemerg med. 2007.09. 011]). The visit rate for elderly blacks rose 90% during that time but did not increase significantly for whites or other races. Researchers used admission rate and number of medications administered (one, two, or three) to gauge the acuity of the visit and found the absolute admission rate increased as did the number of visits in which three or more medications were given, suggesting “older Americans are having more true emergencies, rather than using the ED for convenience.” Ignoring these trends will result in a “serious increase in the problem of ED crowding,” they warned.

Center Takes on Nursing Shortage

A new think tank will address the burgeoning nursing shortage and its impact on the quality of patient care. To achieve this goal, the Center to Champion Nursing in America will focus on increasing funding for nursing education, expanding nurse representation on hospital boards, and informing policy makers and the public about the profession. The shortage is projected to hit 1.1 million by 2020, according to a statement from the Robert Wood Johnson Foundation, which gave the AARP a grant for establishing the center. A study in 2005 by the foundation and Harvard School of Public Health, Boston, found that 60% of Americans considered a shortage of nurses a major factor in poor care in hospitals, two-thirds cited nurses' working conditions as reasons for poor-quality care, and 80% said nursing quality affected their choice of hospital. “If we are going to improve the quality of hospital and nursing care, we need to find ways to fill the pipeline,” said Dr. Risa Lavizzo-Mourey, RWJF president and CEO.

DEA Accused of Electronic Stalling

The Drug Enforcement Administration, which investigates and prosecutes crimes involving illicit use of controlled substances, has been criticized for stalling implementation of a national electronic prescribing system for controlled substances. Sen. Sheldon Whitehouse (D-RI), speaking at a Senate Judiciary Committee hearing on e-prescribing, cited the DEA's tardiness in developing regulations for such a system and its reluctance to commit to a deadline for completing the regulations as the main reasons. Currently, doctors write prescriptions for controlled substances but can prescribe noncontrolled substances electronically, but most doctors use a “pen-and-paper regime” for all prescriptions, said Sen. Whitehouse, who argued that e-prescribing for all medications could save as much as $20 billion a year. Joseph T. Rannazzisi, a deputy assistant administrator for the DEA, told the committee that the agency is concerned an electronic system would be susceptible to abuse.

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. Health, United States, 2007, is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. In 2005, 1 in 10 people between the ages of 18 and 64 years reported they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of costs. The report also found 30% of 18- to 24-year-olds were uninsured, and another 30% of that group did not have a usual source of medical care. In 45- to 64-year-olds, 10% did not have a usual source of care.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that it “suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the agency has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources, meaning that “American lives are at risk,” adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, the Jefferson Pilot Corp. Professor of Neurobiology and Genetics at Duke University, Durham, N.C.; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston.

 

 

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a Nov. 30 letter to reconsider its draft guidance, which he said was close to being finalized. “[It] … would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. “This und ercuts the prohibition on marketing of unapproved uses of drugs and devices.” He requested detailed information on development of the new policy.

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ED Visits by Elderly Increase

The number of emergency department visits among elderly persons could almost double from 6 million in 2003 to almost 12 million by 2013, according to an analysis using National Hospital Ambulatory Medical Care Survey data from 1993 to 2003. The overall rate of admission in patients aged 65–74 years increased 34% during the study period (Ann. Emerg. Med. 2007 Dec. 7 [Epub doi:10.1016/j.annemerg med. 2007.09. 011]). The visit rate for elderly blacks rose 90% but did not increase significantly for other races. Researchers used admission rate and number of medications administered to gauge the acuity of the visit and found the absolute admission rate increased as did the number of visits in which three or more medications were given, suggesting “older Americans are having more true emergencies, rather than using the ED for convenience.” The authors added that, given the aging population, policy makers need to be mindful that ignoring the trend will result in a “serious increase in the problem of ED crowding.”

Center Takes on Nursing Shortage

A new think tank will address the burgeoning nursing shortage and its impact on patient care. The Center to Champion Nursing in America will focus on increasing funding for nursing education, expanding nurse representation on hospital boards, and informing policy makers and the public about the profession. The shortage is projected to hit 1.1 million by 2020, according to a statement from the Robert Wood Johnson Foundation, which gave the AARP a grant to establish the center. A study in 2005 by the foundation and Harvard School of Public Health, Boston, found that 60% of Americans considered a shortage of nurses a major factor in poor care in hospitals, two-thirds cited nurses' working conditions as a reason for poor-quality care, and 80% said nursing quality affected their choice of hospital. “If we are going to improve the quality of hospital care and nursing care, we need to find ways to fill the pipeline,” said Dr. Risa Lavizzo-Mourey, RWJF president and CEO.

DEA Accused of Electronic Stalling

The Drug Enforcement Administration, which prosecutes crimes involving illicit use of controlled substances, has been criticized for stalling implementation of a national electronic prescribing system for controlled substances. At a Senate Judiciary Committee hearing on e-prescribing, Sen. Sheldon Whitehouse (D-RI) cited the DEA's tardiness in developing regulations for such a system and its reluctance to commit to a deadline for completing the regulations as the main reasons. Currently, doctors write prescriptions for controlled substances but can prescribe noncontrolled substances electronically, though most doctors use a “pen-and-paper regime” for all prescriptions, said Sen. Whitehouse, who argued that e-prescribing for all medications could save as much as $20 billion a year. Joseph T. Rannazzisi, a deputy assistant administrator for the DEA, told the committee that the agency is concerned an electronic system would be susceptible to abuse.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that it “suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the agency has become unable to fulfill its mission because of the increasing demands and a lack of resources, meaning that “American lives are at risk,” adding that the agency needs “substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, the Jefferson Pilot Corp. Professor of Neurobiology and Genetics at Duke University, Durham, N.C.; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston.

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a December report by the Centers for Disease Control and Prevention. “Health, United States,” 2007, is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people aged 18–64 years had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care; 10% of 45- to 64-year-olds did not have a usual source of care.

 

 

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a letter to reconsider its draft guidance, which the congressman said was nearly finalized. “[It] … would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA for detailed information on the policy's development.

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ED Visits by Elderly Increase

The number of emergency department visits among elderly persons could almost double from 6 million in 2003 to almost 12 million by 2013, according to an analysis using National Hospital Ambulatory Medical Care Survey data from 1993 to 2003. The overall rate of admission in patients aged 65–74 years increased 34% during the study period (Ann. Emerg. Med. 2007 Dec. 7 [Epub doi:10.1016/j.annemerg med. 2007.09. 011]). The visit rate for elderly blacks rose 90% but did not increase significantly for other races. Researchers used admission rate and number of medications administered to gauge the acuity of the visit and found the absolute admission rate increased as did the number of visits in which three or more medications were given, suggesting “older Americans are having more true emergencies, rather than using the ED for convenience.” The authors added that, given the aging population, policy makers need to be mindful that ignoring the trend will result in a “serious increase in the problem of ED crowding.”

Center Takes on Nursing Shortage

A new think tank will address the burgeoning nursing shortage and its impact on patient care. The Center to Champion Nursing in America will focus on increasing funding for nursing education, expanding nurse representation on hospital boards, and informing policy makers and the public about the profession. The shortage is projected to hit 1.1 million by 2020, according to a statement from the Robert Wood Johnson Foundation, which gave the AARP a grant to establish the center. A study in 2005 by the foundation and Harvard School of Public Health, Boston, found that 60% of Americans considered a shortage of nurses a major factor in poor care in hospitals, two-thirds cited nurses' working conditions as a reason for poor-quality care, and 80% said nursing quality affected their choice of hospital. “If we are going to improve the quality of hospital care and nursing care, we need to find ways to fill the pipeline,” said Dr. Risa Lavizzo-Mourey, RWJF president and CEO.

DEA Accused of Electronic Stalling

The Drug Enforcement Administration, which prosecutes crimes involving illicit use of controlled substances, has been criticized for stalling implementation of a national electronic prescribing system for controlled substances. At a Senate Judiciary Committee hearing on e-prescribing, Sen. Sheldon Whitehouse (D-RI) cited the DEA's tardiness in developing regulations for such a system and its reluctance to commit to a deadline for completing the regulations as the main reasons. Currently, doctors write prescriptions for controlled substances but can prescribe noncontrolled substances electronically, though most doctors use a “pen-and-paper regime” for all prescriptions, said Sen. Whitehouse, who argued that e-prescribing for all medications could save as much as $20 billion a year. Joseph T. Rannazzisi, a deputy assistant administrator for the DEA, told the committee that the agency is concerned an electronic system would be susceptible to abuse.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that it “suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the agency has become unable to fulfill its mission because of the increasing demands and a lack of resources, meaning that “American lives are at risk,” adding that the agency needs “substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, the Jefferson Pilot Corp. Professor of Neurobiology and Genetics at Duke University, Durham, N.C.; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston.

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a December report by the Centers for Disease Control and Prevention. “Health, United States,” 2007, is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people aged 18–64 years had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care; 10% of 45- to 64-year-olds did not have a usual source of care.

 

 

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a letter to reconsider its draft guidance, which the congressman said was nearly finalized. “[It] … would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA for detailed information on the policy's development.

ED Visits by Elderly Increase

The number of emergency department visits among elderly persons could almost double from 6 million in 2003 to almost 12 million by 2013, according to an analysis using National Hospital Ambulatory Medical Care Survey data from 1993 to 2003. The overall rate of admission in patients aged 65–74 years increased 34% during the study period (Ann. Emerg. Med. 2007 Dec. 7 [Epub doi:10.1016/j.annemerg med. 2007.09. 011]). The visit rate for elderly blacks rose 90% but did not increase significantly for other races. Researchers used admission rate and number of medications administered to gauge the acuity of the visit and found the absolute admission rate increased as did the number of visits in which three or more medications were given, suggesting “older Americans are having more true emergencies, rather than using the ED for convenience.” The authors added that, given the aging population, policy makers need to be mindful that ignoring the trend will result in a “serious increase in the problem of ED crowding.”

Center Takes on Nursing Shortage

A new think tank will address the burgeoning nursing shortage and its impact on patient care. The Center to Champion Nursing in America will focus on increasing funding for nursing education, expanding nurse representation on hospital boards, and informing policy makers and the public about the profession. The shortage is projected to hit 1.1 million by 2020, according to a statement from the Robert Wood Johnson Foundation, which gave the AARP a grant to establish the center. A study in 2005 by the foundation and Harvard School of Public Health, Boston, found that 60% of Americans considered a shortage of nurses a major factor in poor care in hospitals, two-thirds cited nurses' working conditions as a reason for poor-quality care, and 80% said nursing quality affected their choice of hospital. “If we are going to improve the quality of hospital care and nursing care, we need to find ways to fill the pipeline,” said Dr. Risa Lavizzo-Mourey, RWJF president and CEO.

DEA Accused of Electronic Stalling

The Drug Enforcement Administration, which prosecutes crimes involving illicit use of controlled substances, has been criticized for stalling implementation of a national electronic prescribing system for controlled substances. At a Senate Judiciary Committee hearing on e-prescribing, Sen. Sheldon Whitehouse (D-RI) cited the DEA's tardiness in developing regulations for such a system and its reluctance to commit to a deadline for completing the regulations as the main reasons. Currently, doctors write prescriptions for controlled substances but can prescribe noncontrolled substances electronically, though most doctors use a “pen-and-paper regime” for all prescriptions, said Sen. Whitehouse, who argued that e-prescribing for all medications could save as much as $20 billion a year. Joseph T. Rannazzisi, a deputy assistant administrator for the DEA, told the committee that the agency is concerned an electronic system would be susceptible to abuse.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that it “suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the agency has become unable to fulfill its mission because of the increasing demands and a lack of resources, meaning that “American lives are at risk,” adding that the agency needs “substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, the Jefferson Pilot Corp. Professor of Neurobiology and Genetics at Duke University, Durham, N.C.; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston.

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a December report by the Centers for Disease Control and Prevention. “Health, United States,” 2007, is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people aged 18–64 years had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care; 10% of 45- to 64-year-olds did not have a usual source of care.

 

 

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a letter to reconsider its draft guidance, which the congressman said was nearly finalized. “[It] … would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA for detailed information on the policy's development.

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Work-Based Coverage Cuts Take Toll

The number of uninsured Americans rose by nearly 9 million, from 38 million in 2000 to 47 million in 2006, mostly as a result of a decline in employer-provided health coverage for workers and their families, according to an analysis by the Economic Policy Institute. Although the affected workers were more likely to be young, low paid, less educated, and other than white, no category was excluded; full-time, college-educated, highly paid workers also lost coverage. In addition, the effects trickled down to children, for whom work-based coverage dipped from 66% in 2000 to 57% in 2006. The report noted that programs such as Medicaid and the State Children's Health Insurance Program are “no longer effective at offsetting these losses.” In comparing the 2000–2001 and 2005–2006 periods, the authors said 38 states had significant losses in coverage, and no state had an increase in the rate.

Patent Losses Choke Drug Sales

The growth of pharmaceutical sales in the United States is expected to increase by 4%–5% next year, a historic low, according to a report by IMS Health Inc. The Norwalk, Conn.-based research firm attributed the slowdown to a leveling of the growth triggered by the Medicare Part D program, closer monitoring of drug safety, payers' desire to contain costs, and the expiration of certain patents and the associated increase in generic use. It said drugs—including some lipid regulators and osteoporosis therapies—with global annual sales of about $20 billion face patent expiry next year, which could spur the growth of generic sales by 14%–15%, to more than $70 billion. The global pharmaceuticals market is expected to grow by about 5%–6% next year, slightly more slowly than this year's 6%–7%, the report said.

Bill Aims to Boost OTC Oversight

Another bill introduced by Rep. Waxman and Sen. Kennedy, along with Rep. Tom Allen (D-Maine), would give the FDA the authority to quickly amend or appeal over-the-counter drug monographs without being required to pursue notice and comment rulemaking, as required under the Administrative Procedures Act. The bill would allow the agency “to act quickly to protect consumers from unsafe or ineffective OTC drugs,” they said in a joint statement. It also would give the FDA authority over OTC drug advertising, which is currently under the purview of the Federal Trade Commission, and would require the FDA to solicit public comment on proposed changes and to file a report to Congress on any findings.

Data on Elderly Glossed Over

Food and Drug Administration regulations for drug makers conducting clinical trials encourage the inclusion of elderly participants and the reporting of data by age, but the agency is not effective in getting its medical officers to include data on elderly patients in their new drug application (NDA) reviews, according to a report by the Government Accountability Office. The report, requested by Rep. Henry Waxman (D-Calif.) and Sen. Ted Kennedy (D-Mass.), was based on a review of 36 NDAs submitted by manufacturers from January 2001 to June 2004 for drugs to treat diseases that could affect those aged 65 years and older. All of the NDAs had at least one trial that included elderly subjects, but a third of the agency's NDA reviews had no documentation on safety or efficacy for that age group. The GAO noted that reviewers don't have to establish whether there was a sufficient number of elderly subjects in a trial, and if they do address sufficiency, they don't have to document their methods. Sufficiency was addressed in about a quarter of the reviews, none of which detailed the methods used, said the report.

Depression No. 2 in Disability Days

Major depression accounts for the second-largest number of days lost to disability in the United States—387 million days a year at the population level, second only to back and neck pain, at 1.2 billion days—according to a study by Harvard University and National Institute of Mental Health researchers. The study was published in the October 2007 issue of the Archives of General Psychiatry. The researchers analyzed data from the National Comorbidity Survey Replication, a nationwide survey of 9,282 adults. Half of the population reported one or more physical or mental conditions that kept them from fully functioning. Individuals averaged 32 days of disability a year. Disability was lowest in students (17.9 individual days), and highest in the unemployed and disabled (121.4 days). The authors said their results echo other study data suggesting that “individual-level effects of mental conditions are as large as those of most chronic physical conditions.”

 

 

Pregnant Women Eschew Meds

A minority of women believe it is safe to take depression medication while they are pregnant, according to a survey by the Society for Women's Health Research. The survey of 1,000 women was conducted by telephone in October; 500 family physicians, general practitioners, and internists were also surveyed. Only 11% of women said they thought it was safe to take a depression therapy during pregnancy, compared with 68% of physicians. Less educated and lower income women and African American women were more likely to believe it was unsafe to take a medication. Half of the women said it was safe post partum, compared with 97% of physicians. Women believed depression was a normal part of the postpartum experience and also underestimated their risk for depression, according to the society. In a statement, Sherry Marts, the society's vice president of scientific affairs, said the survey shows a disconnect between physicians' beliefs about depression and women's perceptions. “The health care community needs to do a better job communicating with women about depression,” she said.

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Work-Based Coverage Cuts Take Toll

The number of uninsured Americans rose by nearly 9 million, from 38 million in 2000 to 47 million in 2006, mostly as a result of a decline in employer-provided health coverage for workers and their families, according to an analysis by the Economic Policy Institute. Although the affected workers were more likely to be young, low paid, less educated, and other than white, no category was excluded; full-time, college-educated, highly paid workers also lost coverage. In addition, the effects trickled down to children, for whom work-based coverage dipped from 66% in 2000 to 57% in 2006. The report noted that programs such as Medicaid and the State Children's Health Insurance Program are “no longer effective at offsetting these losses.” In comparing the 2000–2001 and 2005–2006 periods, the authors said 38 states had significant losses in coverage, and no state had an increase in the rate.

Patent Losses Choke Drug Sales

The growth of pharmaceutical sales in the United States is expected to increase by 4%–5% next year, a historic low, according to a report by IMS Health Inc. The Norwalk, Conn.-based research firm attributed the slowdown to a leveling of the growth triggered by the Medicare Part D program, closer monitoring of drug safety, payers' desire to contain costs, and the expiration of certain patents and the associated increase in generic use. It said drugs—including some lipid regulators and osteoporosis therapies—with global annual sales of about $20 billion face patent expiry next year, which could spur the growth of generic sales by 14%–15%, to more than $70 billion. The global pharmaceuticals market is expected to grow by about 5%–6% next year, slightly more slowly than this year's 6%–7%, the report said.

Bill Aims to Boost OTC Oversight

Another bill introduced by Rep. Waxman and Sen. Kennedy, along with Rep. Tom Allen (D-Maine), would give the FDA the authority to quickly amend or appeal over-the-counter drug monographs without being required to pursue notice and comment rulemaking, as required under the Administrative Procedures Act. The bill would allow the agency “to act quickly to protect consumers from unsafe or ineffective OTC drugs,” they said in a joint statement. It also would give the FDA authority over OTC drug advertising, which is currently under the purview of the Federal Trade Commission, and would require the FDA to solicit public comment on proposed changes and to file a report to Congress on any findings.

Data on Elderly Glossed Over

Food and Drug Administration regulations for drug makers conducting clinical trials encourage the inclusion of elderly participants and the reporting of data by age, but the agency is not effective in getting its medical officers to include data on elderly patients in their new drug application (NDA) reviews, according to a report by the Government Accountability Office. The report, requested by Rep. Henry Waxman (D-Calif.) and Sen. Ted Kennedy (D-Mass.), was based on a review of 36 NDAs submitted by manufacturers from January 2001 to June 2004 for drugs to treat diseases that could affect those aged 65 years and older. All of the NDAs had at least one trial that included elderly subjects, but a third of the agency's NDA reviews had no documentation on safety or efficacy for that age group. The GAO noted that reviewers don't have to establish whether there was a sufficient number of elderly subjects in a trial, and if they do address sufficiency, they don't have to document their methods. Sufficiency was addressed in about a quarter of the reviews, none of which detailed the methods used, said the report.

Depression No. 2 in Disability Days

Major depression accounts for the second-largest number of days lost to disability in the United States—387 million days a year at the population level, second only to back and neck pain, at 1.2 billion days—according to a study by Harvard University and National Institute of Mental Health researchers. The study was published in the October 2007 issue of the Archives of General Psychiatry. The researchers analyzed data from the National Comorbidity Survey Replication, a nationwide survey of 9,282 adults. Half of the population reported one or more physical or mental conditions that kept them from fully functioning. Individuals averaged 32 days of disability a year. Disability was lowest in students (17.9 individual days), and highest in the unemployed and disabled (121.4 days). The authors said their results echo other study data suggesting that “individual-level effects of mental conditions are as large as those of most chronic physical conditions.”

 

 

Pregnant Women Eschew Meds

A minority of women believe it is safe to take depression medication while they are pregnant, according to a survey by the Society for Women's Health Research. The survey of 1,000 women was conducted by telephone in October; 500 family physicians, general practitioners, and internists were also surveyed. Only 11% of women said they thought it was safe to take a depression therapy during pregnancy, compared with 68% of physicians. Less educated and lower income women and African American women were more likely to believe it was unsafe to take a medication. Half of the women said it was safe post partum, compared with 97% of physicians. Women believed depression was a normal part of the postpartum experience and also underestimated their risk for depression, according to the society. In a statement, Sherry Marts, the society's vice president of scientific affairs, said the survey shows a disconnect between physicians' beliefs about depression and women's perceptions. “The health care community needs to do a better job communicating with women about depression,” she said.

Work-Based Coverage Cuts Take Toll

The number of uninsured Americans rose by nearly 9 million, from 38 million in 2000 to 47 million in 2006, mostly as a result of a decline in employer-provided health coverage for workers and their families, according to an analysis by the Economic Policy Institute. Although the affected workers were more likely to be young, low paid, less educated, and other than white, no category was excluded; full-time, college-educated, highly paid workers also lost coverage. In addition, the effects trickled down to children, for whom work-based coverage dipped from 66% in 2000 to 57% in 2006. The report noted that programs such as Medicaid and the State Children's Health Insurance Program are “no longer effective at offsetting these losses.” In comparing the 2000–2001 and 2005–2006 periods, the authors said 38 states had significant losses in coverage, and no state had an increase in the rate.

Patent Losses Choke Drug Sales

The growth of pharmaceutical sales in the United States is expected to increase by 4%–5% next year, a historic low, according to a report by IMS Health Inc. The Norwalk, Conn.-based research firm attributed the slowdown to a leveling of the growth triggered by the Medicare Part D program, closer monitoring of drug safety, payers' desire to contain costs, and the expiration of certain patents and the associated increase in generic use. It said drugs—including some lipid regulators and osteoporosis therapies—with global annual sales of about $20 billion face patent expiry next year, which could spur the growth of generic sales by 14%–15%, to more than $70 billion. The global pharmaceuticals market is expected to grow by about 5%–6% next year, slightly more slowly than this year's 6%–7%, the report said.

Bill Aims to Boost OTC Oversight

Another bill introduced by Rep. Waxman and Sen. Kennedy, along with Rep. Tom Allen (D-Maine), would give the FDA the authority to quickly amend or appeal over-the-counter drug monographs without being required to pursue notice and comment rulemaking, as required under the Administrative Procedures Act. The bill would allow the agency “to act quickly to protect consumers from unsafe or ineffective OTC drugs,” they said in a joint statement. It also would give the FDA authority over OTC drug advertising, which is currently under the purview of the Federal Trade Commission, and would require the FDA to solicit public comment on proposed changes and to file a report to Congress on any findings.

Data on Elderly Glossed Over

Food and Drug Administration regulations for drug makers conducting clinical trials encourage the inclusion of elderly participants and the reporting of data by age, but the agency is not effective in getting its medical officers to include data on elderly patients in their new drug application (NDA) reviews, according to a report by the Government Accountability Office. The report, requested by Rep. Henry Waxman (D-Calif.) and Sen. Ted Kennedy (D-Mass.), was based on a review of 36 NDAs submitted by manufacturers from January 2001 to June 2004 for drugs to treat diseases that could affect those aged 65 years and older. All of the NDAs had at least one trial that included elderly subjects, but a third of the agency's NDA reviews had no documentation on safety or efficacy for that age group. The GAO noted that reviewers don't have to establish whether there was a sufficient number of elderly subjects in a trial, and if they do address sufficiency, they don't have to document their methods. Sufficiency was addressed in about a quarter of the reviews, none of which detailed the methods used, said the report.

Depression No. 2 in Disability Days

Major depression accounts for the second-largest number of days lost to disability in the United States—387 million days a year at the population level, second only to back and neck pain, at 1.2 billion days—according to a study by Harvard University and National Institute of Mental Health researchers. The study was published in the October 2007 issue of the Archives of General Psychiatry. The researchers analyzed data from the National Comorbidity Survey Replication, a nationwide survey of 9,282 adults. Half of the population reported one or more physical or mental conditions that kept them from fully functioning. Individuals averaged 32 days of disability a year. Disability was lowest in students (17.9 individual days), and highest in the unemployed and disabled (121.4 days). The authors said their results echo other study data suggesting that “individual-level effects of mental conditions are as large as those of most chronic physical conditions.”

 

 

Pregnant Women Eschew Meds

A minority of women believe it is safe to take depression medication while they are pregnant, according to a survey by the Society for Women's Health Research. The survey of 1,000 women was conducted by telephone in October; 500 family physicians, general practitioners, and internists were also surveyed. Only 11% of women said they thought it was safe to take a depression therapy during pregnancy, compared with 68% of physicians. Less educated and lower income women and African American women were more likely to believe it was unsafe to take a medication. Half of the women said it was safe post partum, compared with 97% of physicians. Women believed depression was a normal part of the postpartum experience and also underestimated their risk for depression, according to the society. In a statement, Sherry Marts, the society's vice president of scientific affairs, said the survey shows a disconnect between physicians' beliefs about depression and women's perceptions. “The health care community needs to do a better job communicating with women about depression,” she said.

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Work-Based Coverage Cuts Take Toll

The number of uninsured Americans rose by nearly 9 million, from 38 million in 2000 to 47 million in 2006, mostly as a result of a decline in employer-provided health coverage for workers and their families, according to an analysis by the Economic Policy Institute. Although the affected workers were more likely to be young, low paid, less educated, and other than white, no category was excluded; full-time, college-educated, highly paid workers also lost coverage. In addition, the effects trickled down to children, for whom work-based coverage dipped from 66% in 2000 to 57% in 2006. The report noted that programs such as Medicaid and the State Children's Health Insurance Program are “no longer effective at offsetting these losses.” In comparing the 2000–2001 and 2005–2006 periods, the authors said that 38 states had significant losses in coverage, and no state had an increase in the rate.

Patent Losses Choke Drug Sales

The growth of pharmaceutical sales in the United States is expected to increase by 4%–5% next year, reaching an historic low, according to a report by IMS Health Inc. The Norwalk, Conn.-based research firm attributed the slowdown to a leveling of the growth triggered by the Medicare Part D program, closer monitoring of drug safety, payers' desire to contain costs, and the expiration of certain patents and the associated increase in generic use. The report said that drugs—including some lipid regulators and osteoporosis therapies—with global annual sales of about $20 billion face patent expiration next year, which could spur the growth of generic sales by 14%–15%, to more than $70 billion. The global pharmaceuticals market is expected to grow by about 5%–6% next year, which is slightly more slowly than this year's 6%–7%, according to the report.

Data on Elderly Glossed Over

Food and Drug Administration regulations for drug makers conducting clinical trials encourage the inclusion of elderly participants and the reporting of data by age, but the agency is not effective in getting its medical officers to include data on elderly patients in their new drug application (NDA) reviews, according to a report by the Government Accountability Office. The report, requested by Rep. Henry Waxman (D-Calif.) and Sen. Ted Kennedy (D-Mass.), was based on a review of 36 NDAs submitted by manufacturers from January 2001 to June 2004 for drugs to treat diseases that could affect patients aged 65 years and older. All of the NDAs had at least one trial that included elderly participants, but a third of the agency's NDA reviews had no documentation on safety or efficacy for that age group. In addition, the GAO noted that reviewers are not required to establish whether there was a sufficient number of elderly participants in a trial, and if they do address sufficiency, they do not have to document their methods. Sufficiency was addressed in about a quarter of the reviews, none of which detailed the methods used, the report found.

Depression No. 2 in Disability Days

Major depression accounts for the second-largest number of days lost to disability in the United States—387 million days a year at the population level, second only to back and neck pain, at 1.2 billion days—according to a study by Harvard University and National Institute of Mental Health researchers. The study was published in the October 2007 issue of the Archives of General Psychiatry. The researchers analyzed data from the National Comorbidity Survey Replication, a nationwide survey of 9,282 adults. Half of the population reported one or more physical or mental conditions that kept them from fully functioning. Individuals averaged 32 days of disability a year. Disability was lowest in students (17.9 individual days), and highest in the unemployed and disabled (121.4 days). The authors said their results echo other study data suggesting that “individual-level effects of mental conditions are as large as those of most chronic physical conditions.”

Bill Aims to Boost OTC Oversight

Another bill introduced by Rep. Waxman and Sen. Kennedy, along with Rep. Tom Allen (D-Maine), would give the FDA the authority to quickly amend or appeal over-the-counter drug monographs without being required to pursue notice and comment rulemaking, as required under the Administrative Procedures Act. The bill would allow the agency “to act quickly to protect consumers from unsafe or ineffective OTC drugs,” they said in a joint statement. It also would give the FDA authority over OTC drug advertising, which is currently under the purview of the Federal Trade Commission, and would require the FDA to solicit public comment on proposed changes and to file a report to Congress on any findings.

 

 

MRSA Mortality Reaches 5%

Almost 5% of all patients hospitalized in 2004 with a methicillin-resistant Staphylococcus aureus (MRSA) infection died, according to a statistical brief by the Agency for Healthcare Research and Quality. Hospital stays for patients with a MRSA infection were both longer (10 days vs. 5 days) and more expensive ($14,000 vs. $7,600) than stays for patients with other conditions. The number of hospital stays for MRSA increased from 1,900 in 1993 to 368,600 in 2005, and more commonly occurred in Medicare patients and those aged 65 years and older. Males and people in the South were also more likely to be hospitalized for MRSA treatment.

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Work-Based Coverage Cuts Take Toll

The number of uninsured Americans rose by nearly 9 million, from 38 million in 2000 to 47 million in 2006, mostly as a result of a decline in employer-provided health coverage for workers and their families, according to an analysis by the Economic Policy Institute. Although the affected workers were more likely to be young, low paid, less educated, and other than white, no category was excluded; full-time, college-educated, highly paid workers also lost coverage. In addition, the effects trickled down to children, for whom work-based coverage dipped from 66% in 2000 to 57% in 2006. The report noted that programs such as Medicaid and the State Children's Health Insurance Program are “no longer effective at offsetting these losses.” In comparing the 2000–2001 and 2005–2006 periods, the authors said that 38 states had significant losses in coverage, and no state had an increase in the rate.

Patent Losses Choke Drug Sales

The growth of pharmaceutical sales in the United States is expected to increase by 4%–5% next year, reaching an historic low, according to a report by IMS Health Inc. The Norwalk, Conn.-based research firm attributed the slowdown to a leveling of the growth triggered by the Medicare Part D program, closer monitoring of drug safety, payers' desire to contain costs, and the expiration of certain patents and the associated increase in generic use. The report said that drugs—including some lipid regulators and osteoporosis therapies—with global annual sales of about $20 billion face patent expiration next year, which could spur the growth of generic sales by 14%–15%, to more than $70 billion. The global pharmaceuticals market is expected to grow by about 5%–6% next year, which is slightly more slowly than this year's 6%–7%, according to the report.

Data on Elderly Glossed Over

Food and Drug Administration regulations for drug makers conducting clinical trials encourage the inclusion of elderly participants and the reporting of data by age, but the agency is not effective in getting its medical officers to include data on elderly patients in their new drug application (NDA) reviews, according to a report by the Government Accountability Office. The report, requested by Rep. Henry Waxman (D-Calif.) and Sen. Ted Kennedy (D-Mass.), was based on a review of 36 NDAs submitted by manufacturers from January 2001 to June 2004 for drugs to treat diseases that could affect patients aged 65 years and older. All of the NDAs had at least one trial that included elderly participants, but a third of the agency's NDA reviews had no documentation on safety or efficacy for that age group. In addition, the GAO noted that reviewers are not required to establish whether there was a sufficient number of elderly participants in a trial, and if they do address sufficiency, they do not have to document their methods. Sufficiency was addressed in about a quarter of the reviews, none of which detailed the methods used, the report found.

Depression No. 2 in Disability Days

Major depression accounts for the second-largest number of days lost to disability in the United States—387 million days a year at the population level, second only to back and neck pain, at 1.2 billion days—according to a study by Harvard University and National Institute of Mental Health researchers. The study was published in the October 2007 issue of the Archives of General Psychiatry. The researchers analyzed data from the National Comorbidity Survey Replication, a nationwide survey of 9,282 adults. Half of the population reported one or more physical or mental conditions that kept them from fully functioning. Individuals averaged 32 days of disability a year. Disability was lowest in students (17.9 individual days), and highest in the unemployed and disabled (121.4 days). The authors said their results echo other study data suggesting that “individual-level effects of mental conditions are as large as those of most chronic physical conditions.”

Bill Aims to Boost OTC Oversight

Another bill introduced by Rep. Waxman and Sen. Kennedy, along with Rep. Tom Allen (D-Maine), would give the FDA the authority to quickly amend or appeal over-the-counter drug monographs without being required to pursue notice and comment rulemaking, as required under the Administrative Procedures Act. The bill would allow the agency “to act quickly to protect consumers from unsafe or ineffective OTC drugs,” they said in a joint statement. It also would give the FDA authority over OTC drug advertising, which is currently under the purview of the Federal Trade Commission, and would require the FDA to solicit public comment on proposed changes and to file a report to Congress on any findings.

 

 

MRSA Mortality Reaches 5%

Almost 5% of all patients hospitalized in 2004 with a methicillin-resistant Staphylococcus aureus (MRSA) infection died, according to a statistical brief by the Agency for Healthcare Research and Quality. Hospital stays for patients with a MRSA infection were both longer (10 days vs. 5 days) and more expensive ($14,000 vs. $7,600) than stays for patients with other conditions. The number of hospital stays for MRSA increased from 1,900 in 1993 to 368,600 in 2005, and more commonly occurred in Medicare patients and those aged 65 years and older. Males and people in the South were also more likely to be hospitalized for MRSA treatment.

Work-Based Coverage Cuts Take Toll

The number of uninsured Americans rose by nearly 9 million, from 38 million in 2000 to 47 million in 2006, mostly as a result of a decline in employer-provided health coverage for workers and their families, according to an analysis by the Economic Policy Institute. Although the affected workers were more likely to be young, low paid, less educated, and other than white, no category was excluded; full-time, college-educated, highly paid workers also lost coverage. In addition, the effects trickled down to children, for whom work-based coverage dipped from 66% in 2000 to 57% in 2006. The report noted that programs such as Medicaid and the State Children's Health Insurance Program are “no longer effective at offsetting these losses.” In comparing the 2000–2001 and 2005–2006 periods, the authors said that 38 states had significant losses in coverage, and no state had an increase in the rate.

Patent Losses Choke Drug Sales

The growth of pharmaceutical sales in the United States is expected to increase by 4%–5% next year, reaching an historic low, according to a report by IMS Health Inc. The Norwalk, Conn.-based research firm attributed the slowdown to a leveling of the growth triggered by the Medicare Part D program, closer monitoring of drug safety, payers' desire to contain costs, and the expiration of certain patents and the associated increase in generic use. The report said that drugs—including some lipid regulators and osteoporosis therapies—with global annual sales of about $20 billion face patent expiration next year, which could spur the growth of generic sales by 14%–15%, to more than $70 billion. The global pharmaceuticals market is expected to grow by about 5%–6% next year, which is slightly more slowly than this year's 6%–7%, according to the report.

Data on Elderly Glossed Over

Food and Drug Administration regulations for drug makers conducting clinical trials encourage the inclusion of elderly participants and the reporting of data by age, but the agency is not effective in getting its medical officers to include data on elderly patients in their new drug application (NDA) reviews, according to a report by the Government Accountability Office. The report, requested by Rep. Henry Waxman (D-Calif.) and Sen. Ted Kennedy (D-Mass.), was based on a review of 36 NDAs submitted by manufacturers from January 2001 to June 2004 for drugs to treat diseases that could affect patients aged 65 years and older. All of the NDAs had at least one trial that included elderly participants, but a third of the agency's NDA reviews had no documentation on safety or efficacy for that age group. In addition, the GAO noted that reviewers are not required to establish whether there was a sufficient number of elderly participants in a trial, and if they do address sufficiency, they do not have to document their methods. Sufficiency was addressed in about a quarter of the reviews, none of which detailed the methods used, the report found.

Depression No. 2 in Disability Days

Major depression accounts for the second-largest number of days lost to disability in the United States—387 million days a year at the population level, second only to back and neck pain, at 1.2 billion days—according to a study by Harvard University and National Institute of Mental Health researchers. The study was published in the October 2007 issue of the Archives of General Psychiatry. The researchers analyzed data from the National Comorbidity Survey Replication, a nationwide survey of 9,282 adults. Half of the population reported one or more physical or mental conditions that kept them from fully functioning. Individuals averaged 32 days of disability a year. Disability was lowest in students (17.9 individual days), and highest in the unemployed and disabled (121.4 days). The authors said their results echo other study data suggesting that “individual-level effects of mental conditions are as large as those of most chronic physical conditions.”

Bill Aims to Boost OTC Oversight

Another bill introduced by Rep. Waxman and Sen. Kennedy, along with Rep. Tom Allen (D-Maine), would give the FDA the authority to quickly amend or appeal over-the-counter drug monographs without being required to pursue notice and comment rulemaking, as required under the Administrative Procedures Act. The bill would allow the agency “to act quickly to protect consumers from unsafe or ineffective OTC drugs,” they said in a joint statement. It also would give the FDA authority over OTC drug advertising, which is currently under the purview of the Federal Trade Commission, and would require the FDA to solicit public comment on proposed changes and to file a report to Congress on any findings.

 

 

MRSA Mortality Reaches 5%

Almost 5% of all patients hospitalized in 2004 with a methicillin-resistant Staphylococcus aureus (MRSA) infection died, according to a statistical brief by the Agency for Healthcare Research and Quality. Hospital stays for patients with a MRSA infection were both longer (10 days vs. 5 days) and more expensive ($14,000 vs. $7,600) than stays for patients with other conditions. The number of hospital stays for MRSA increased from 1,900 in 1993 to 368,600 in 2005, and more commonly occurred in Medicare patients and those aged 65 years and older. Males and people in the South were also more likely to be hospitalized for MRSA treatment.

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Part B Premium Up 3.1% for Most Beneficiaries

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Part B Premium Up 3.1% for Most Beneficiaries

The standard monthly Medicare Part B premium will increase to $96.40 next year, up 3.1% from the current $93.50, Kerry Weems, the administrator of the Centers for Medicare and Medicaid Services announced in a teleconference with reporters.

That amount will be paid by individuals with an annual income of $82,000 or less or couples with $160,000 or less a year, approximately 95% of all Medicare beneficiaries, according to the agency.

Next year, Part B premiums again will be tied to beneficiary income as required by the Medicare Modernization Act. As income goes up, so does the premium and the amount of increase. For example, beneficiaries in the top bracket (those with annual income of more than $205,000 or more than $410,000 for couples), the amount will increase to $238.40, by $77 or 48%, from this year's $161.40. The Part B deductible also will increase to $135 from the current $131.

The increases are a result of growth in certain areas of Medicare's fee-for-service program, including home health services and independent lab and physician-administered drugs, and in the Medicare Advantage program, as well as the need to increase contingency reserves in the Part B trust fund, Mr. Weems said.

Dr. Edward Langston, who is the chair of the American Medical Association Board of Trustees, expressed concern that government is cutting payment to doctors who care for the majority of Medicare patients who are in effect “helping subsidize overpayments to private insurance companies [providing Medicare Advantage plans], while only one in five Medicare patients participates,” he said in a statement.

The AMA is calling on Congress to eliminate overpayments to Medicare Advantage plans.

CMS also announced increases in the Medicare Part A deductible and in the premium for those who must “buy in” for coverage. Beneficiaries who have less than 30 quarters of coverage would have to pay $432, up $13 from the current $419. The Part A deductible, payable at first hospital admission, will increase to $1,024, up $32 from the current $992.

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The standard monthly Medicare Part B premium will increase to $96.40 next year, up 3.1% from the current $93.50, Kerry Weems, the administrator of the Centers for Medicare and Medicaid Services announced in a teleconference with reporters.

That amount will be paid by individuals with an annual income of $82,000 or less or couples with $160,000 or less a year, approximately 95% of all Medicare beneficiaries, according to the agency.

Next year, Part B premiums again will be tied to beneficiary income as required by the Medicare Modernization Act. As income goes up, so does the premium and the amount of increase. For example, beneficiaries in the top bracket (those with annual income of more than $205,000 or more than $410,000 for couples), the amount will increase to $238.40, by $77 or 48%, from this year's $161.40. The Part B deductible also will increase to $135 from the current $131.

The increases are a result of growth in certain areas of Medicare's fee-for-service program, including home health services and independent lab and physician-administered drugs, and in the Medicare Advantage program, as well as the need to increase contingency reserves in the Part B trust fund, Mr. Weems said.

Dr. Edward Langston, who is the chair of the American Medical Association Board of Trustees, expressed concern that government is cutting payment to doctors who care for the majority of Medicare patients who are in effect “helping subsidize overpayments to private insurance companies [providing Medicare Advantage plans], while only one in five Medicare patients participates,” he said in a statement.

The AMA is calling on Congress to eliminate overpayments to Medicare Advantage plans.

CMS also announced increases in the Medicare Part A deductible and in the premium for those who must “buy in” for coverage. Beneficiaries who have less than 30 quarters of coverage would have to pay $432, up $13 from the current $419. The Part A deductible, payable at first hospital admission, will increase to $1,024, up $32 from the current $992.

The standard monthly Medicare Part B premium will increase to $96.40 next year, up 3.1% from the current $93.50, Kerry Weems, the administrator of the Centers for Medicare and Medicaid Services announced in a teleconference with reporters.

That amount will be paid by individuals with an annual income of $82,000 or less or couples with $160,000 or less a year, approximately 95% of all Medicare beneficiaries, according to the agency.

Next year, Part B premiums again will be tied to beneficiary income as required by the Medicare Modernization Act. As income goes up, so does the premium and the amount of increase. For example, beneficiaries in the top bracket (those with annual income of more than $205,000 or more than $410,000 for couples), the amount will increase to $238.40, by $77 or 48%, from this year's $161.40. The Part B deductible also will increase to $135 from the current $131.

The increases are a result of growth in certain areas of Medicare's fee-for-service program, including home health services and independent lab and physician-administered drugs, and in the Medicare Advantage program, as well as the need to increase contingency reserves in the Part B trust fund, Mr. Weems said.

Dr. Edward Langston, who is the chair of the American Medical Association Board of Trustees, expressed concern that government is cutting payment to doctors who care for the majority of Medicare patients who are in effect “helping subsidize overpayments to private insurance companies [providing Medicare Advantage plans], while only one in five Medicare patients participates,” he said in a statement.

The AMA is calling on Congress to eliminate overpayments to Medicare Advantage plans.

CMS also announced increases in the Medicare Part A deductible and in the premium for those who must “buy in” for coverage. Beneficiaries who have less than 30 quarters of coverage would have to pay $432, up $13 from the current $419. The Part A deductible, payable at first hospital admission, will increase to $1,024, up $32 from the current $992.

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CMS Announces Higher Medicare Part B Premiums for 2008

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CMS Announces Higher Medicare Part B Premiums for 2008

The standard monthly Medicare Part B premium will rise to $96.40 next year, up 3.1% from the current $93.50, Kerry Weems, administrator of the Centers for Medicare and Medicaid Services announced in a teleconference with reporters.

That amount will be paid by individuals with an annual income of $82,000 or less, or couples with $160,000 or less a year—approximately 95% of all Medicare beneficiaries, according to the agency.

Next year, Part B premiums again will be tied to beneficiary income, as required by the Medicare Modernization Act. For example, for beneficiaries in the top bracket (annual income above $205,000, or above $410,000 for couples), the amount will increase to $238.40, up from this year's $161.40. The Part B deductible also will rise to $135 from the current $131.

The increases reflect higher fee-for-service costs—including for home health services and physician-administered drugs, and for the Medicare Advantage program—as well as the need to increase contingency reserves in the Part B trust fund, Mr. Weems said.

Dr. Edward Langston, chair of the American Medical Association Board of Trustees, expressed concern in a statement that government is cutting payment to doctors who care for the majority of Medicare patients who are in effect “helping subsidize overpayments to private insurance companies” that provide Medicare Advantage plans.

The AMA is urging Congress to eliminate overpayments to Medicare Advantage plans. CMS also announced increases in the Medicare Part A deductible and in the premium for those who must “buy in” for coverage. Beneficiaries who have less than 30 quarters of coverage would have to pay $432, up $13 from the current $419. The Part A deductible, payable at first hospital admission, will rise to $1,024, up $32 from the current $992, Mr. Weems said.

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The standard monthly Medicare Part B premium will rise to $96.40 next year, up 3.1% from the current $93.50, Kerry Weems, administrator of the Centers for Medicare and Medicaid Services announced in a teleconference with reporters.

That amount will be paid by individuals with an annual income of $82,000 or less, or couples with $160,000 or less a year—approximately 95% of all Medicare beneficiaries, according to the agency.

Next year, Part B premiums again will be tied to beneficiary income, as required by the Medicare Modernization Act. For example, for beneficiaries in the top bracket (annual income above $205,000, or above $410,000 for couples), the amount will increase to $238.40, up from this year's $161.40. The Part B deductible also will rise to $135 from the current $131.

The increases reflect higher fee-for-service costs—including for home health services and physician-administered drugs, and for the Medicare Advantage program—as well as the need to increase contingency reserves in the Part B trust fund, Mr. Weems said.

Dr. Edward Langston, chair of the American Medical Association Board of Trustees, expressed concern in a statement that government is cutting payment to doctors who care for the majority of Medicare patients who are in effect “helping subsidize overpayments to private insurance companies” that provide Medicare Advantage plans.

The AMA is urging Congress to eliminate overpayments to Medicare Advantage plans. CMS also announced increases in the Medicare Part A deductible and in the premium for those who must “buy in” for coverage. Beneficiaries who have less than 30 quarters of coverage would have to pay $432, up $13 from the current $419. The Part A deductible, payable at first hospital admission, will rise to $1,024, up $32 from the current $992, Mr. Weems said.

The standard monthly Medicare Part B premium will rise to $96.40 next year, up 3.1% from the current $93.50, Kerry Weems, administrator of the Centers for Medicare and Medicaid Services announced in a teleconference with reporters.

That amount will be paid by individuals with an annual income of $82,000 or less, or couples with $160,000 or less a year—approximately 95% of all Medicare beneficiaries, according to the agency.

Next year, Part B premiums again will be tied to beneficiary income, as required by the Medicare Modernization Act. For example, for beneficiaries in the top bracket (annual income above $205,000, or above $410,000 for couples), the amount will increase to $238.40, up from this year's $161.40. The Part B deductible also will rise to $135 from the current $131.

The increases reflect higher fee-for-service costs—including for home health services and physician-administered drugs, and for the Medicare Advantage program—as well as the need to increase contingency reserves in the Part B trust fund, Mr. Weems said.

Dr. Edward Langston, chair of the American Medical Association Board of Trustees, expressed concern in a statement that government is cutting payment to doctors who care for the majority of Medicare patients who are in effect “helping subsidize overpayments to private insurance companies” that provide Medicare Advantage plans.

The AMA is urging Congress to eliminate overpayments to Medicare Advantage plans. CMS also announced increases in the Medicare Part A deductible and in the premium for those who must “buy in” for coverage. Beneficiaries who have less than 30 quarters of coverage would have to pay $432, up $13 from the current $419. The Part A deductible, payable at first hospital admission, will rise to $1,024, up $32 from the current $992, Mr. Weems said.

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WHI Results Still Confusing

Just 18% of physicians said they have “no confusion at all” about the results of the Women's Health Initiative study, according to an online survey of more than 400 physicians conducted on behalf of The Hormone Foundation. In addition, only 15% said they believe patients accurately understand the risks of hormone therapy. The results “underscore the importance of physicians' role in educating patients and [the public] on menopause management,” said foundation director Paula Correa. The survey, sponsored by Novogyne Pharmaceuticals, also found that 74% of physicians still consider hormone therapy as a first-line treatment for menopause symptoms. Novogyne manufactures the hormone therapy patches, Vivelle-Dot, Vivelle, and CombiPatch.

Aventis Settles Pricing Fraud Case

Drugmaker Sanofi-Aventis has agreed to pay more than $190 million to settle allegations of fraudulent drug pricing and marketing against Aventis Pharmaceuticals, one of its predecessor companies. According to the U.S. Department of Justice, Aventis used the difference between the inflated prices that were used to set reimbursement rates and the actual prices charged to customers to market the antiemetic, Anzemet. In doing so, it caused fraudulent claims to be submitted to Medicare and other federal health care programs. The case arose after Ven-A-Care of the Florida Keys Inc. filed a False Claims Act suit, which allows a private person to file a whistle-blower suit on behalf of government. To continue working with federal programs, Sanofi-Aventis agreed to report accurate prices. Almost $180 million of the settlement will go to the federal government and the balance, to states and the District of Columbia. The whistle blowers will receive about $32 million.

Insurance Premium Increase Slows

Employer-sponsored health insurance premiums rose on average 6.1% in 2007, reflecting a continuing slowdown in premium increases. The 2007 premium increase is the smallest hike since 1999, according to an employer survey by the Kaiser Family Foundation and the Health Research and Educational Trust. But experts say the slowdown is likely temporary and isn't providing relief to individuals or employers. In fact, the 6.1% increase is higher than the average increase in wages (3.7%) and in the overall inflation rate (2.6%). In 2007, the average premium for family coverage in the United States is $12,106 with workers paying about $3,281 for their share of the policy. The market continues to be dominated by preferred provider organizations, which insure about 57% of covered workers; consumer-driven plans account for only about 5%. For details, visit

www.kff.org/insurance/7672

Rise in Adverse Drug Event Reports

The number of serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration more than doubled between 1998 and 2005, according to a report in the Sept. 10 issue of Archives of Internal Medicine. The agency defines a serious adverse event as an event resulting in death, a birth defect, disability, hospitalization, or that requires intervention. During the 8-year period, 467,809 serious events met the inclusion criteria. The number of reported serious ADEs increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label. Contrary to expectation, drugs related to safety withdrawals accounted for a “modest share” of reported events and declined over time. Of the 15 drugs most frequently cited in fatal events, there was a “disproportionate contribution of pain medications [7] and drugs that modify the immune system [4].” Drugs named in serious ADEs spanned a variety of classes, but within that group, events tied to 13 new biotechnology products increased almost 16-fold, from 580 in 1998 to 9,181 in 2005.

Bill Seeks MD Gift Disclosure

Legislation in the Senate would require quarterly disclosure of gifts, honoraria, travel, and other payments to physicians by pharmaceutical, medical device, and biotechnology manufacturers. S. 2029 was introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.) and would apply to manufacturers with more than $100 million in gross revenues. The U.S. Health and Human Services Department would be required to make the disclosure data available on the Internet. Penalties would range from $10,000 to $100,000 per violation. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his group had not yet reviewed the bill but that contact with physicians is essential for education purposes. The group's guidelines suggest gifts to physicians should not exceed $100. The American Medical Association had also not yet read the proposal, but in testimony earlier this year, noted that it has extensive guidelines on accepting anything from industry.

 

 

Mass. Considers Retail Clinic Rules

Massachusetts' Public Health Council is considering rules that would limit the scope of retail medical clinics in the state. The proposal is in response to a request by CVS Corp. to open 20–30 of its MinuteClinics in the Boston area beginning this fall. Under the proposal, applicants would need to: state what services they intend to provide; develop policies that limit the number of times each patient could receive care there; and refer patients without a primary care physician to one in the area who is accepting new patients.

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WHI Results Still Confusing

Just 18% of physicians said they have “no confusion at all” about the results of the Women's Health Initiative study, according to an online survey of more than 400 physicians conducted on behalf of The Hormone Foundation. In addition, only 15% said they believe patients accurately understand the risks of hormone therapy. The results “underscore the importance of physicians' role in educating patients and [the public] on menopause management,” said foundation director Paula Correa. The survey, sponsored by Novogyne Pharmaceuticals, also found that 74% of physicians still consider hormone therapy as a first-line treatment for menopause symptoms. Novogyne manufactures the hormone therapy patches, Vivelle-Dot, Vivelle, and CombiPatch.

Aventis Settles Pricing Fraud Case

Drugmaker Sanofi-Aventis has agreed to pay more than $190 million to settle allegations of fraudulent drug pricing and marketing against Aventis Pharmaceuticals, one of its predecessor companies. According to the U.S. Department of Justice, Aventis used the difference between the inflated prices that were used to set reimbursement rates and the actual prices charged to customers to market the antiemetic, Anzemet. In doing so, it caused fraudulent claims to be submitted to Medicare and other federal health care programs. The case arose after Ven-A-Care of the Florida Keys Inc. filed a False Claims Act suit, which allows a private person to file a whistle-blower suit on behalf of government. To continue working with federal programs, Sanofi-Aventis agreed to report accurate prices. Almost $180 million of the settlement will go to the federal government and the balance, to states and the District of Columbia. The whistle blowers will receive about $32 million.

Insurance Premium Increase Slows

Employer-sponsored health insurance premiums rose on average 6.1% in 2007, reflecting a continuing slowdown in premium increases. The 2007 premium increase is the smallest hike since 1999, according to an employer survey by the Kaiser Family Foundation and the Health Research and Educational Trust. But experts say the slowdown is likely temporary and isn't providing relief to individuals or employers. In fact, the 6.1% increase is higher than the average increase in wages (3.7%) and in the overall inflation rate (2.6%). In 2007, the average premium for family coverage in the United States is $12,106 with workers paying about $3,281 for their share of the policy. The market continues to be dominated by preferred provider organizations, which insure about 57% of covered workers; consumer-driven plans account for only about 5%. For details, visit

www.kff.org/insurance/7672

Rise in Adverse Drug Event Reports

The number of serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration more than doubled between 1998 and 2005, according to a report in the Sept. 10 issue of Archives of Internal Medicine. The agency defines a serious adverse event as an event resulting in death, a birth defect, disability, hospitalization, or that requires intervention. During the 8-year period, 467,809 serious events met the inclusion criteria. The number of reported serious ADEs increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label. Contrary to expectation, drugs related to safety withdrawals accounted for a “modest share” of reported events and declined over time. Of the 15 drugs most frequently cited in fatal events, there was a “disproportionate contribution of pain medications [7] and drugs that modify the immune system [4].” Drugs named in serious ADEs spanned a variety of classes, but within that group, events tied to 13 new biotechnology products increased almost 16-fold, from 580 in 1998 to 9,181 in 2005.

Bill Seeks MD Gift Disclosure

Legislation in the Senate would require quarterly disclosure of gifts, honoraria, travel, and other payments to physicians by pharmaceutical, medical device, and biotechnology manufacturers. S. 2029 was introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.) and would apply to manufacturers with more than $100 million in gross revenues. The U.S. Health and Human Services Department would be required to make the disclosure data available on the Internet. Penalties would range from $10,000 to $100,000 per violation. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his group had not yet reviewed the bill but that contact with physicians is essential for education purposes. The group's guidelines suggest gifts to physicians should not exceed $100. The American Medical Association had also not yet read the proposal, but in testimony earlier this year, noted that it has extensive guidelines on accepting anything from industry.

 

 

Mass. Considers Retail Clinic Rules

Massachusetts' Public Health Council is considering rules that would limit the scope of retail medical clinics in the state. The proposal is in response to a request by CVS Corp. to open 20–30 of its MinuteClinics in the Boston area beginning this fall. Under the proposal, applicants would need to: state what services they intend to provide; develop policies that limit the number of times each patient could receive care there; and refer patients without a primary care physician to one in the area who is accepting new patients.

WHI Results Still Confusing

Just 18% of physicians said they have “no confusion at all” about the results of the Women's Health Initiative study, according to an online survey of more than 400 physicians conducted on behalf of The Hormone Foundation. In addition, only 15% said they believe patients accurately understand the risks of hormone therapy. The results “underscore the importance of physicians' role in educating patients and [the public] on menopause management,” said foundation director Paula Correa. The survey, sponsored by Novogyne Pharmaceuticals, also found that 74% of physicians still consider hormone therapy as a first-line treatment for menopause symptoms. Novogyne manufactures the hormone therapy patches, Vivelle-Dot, Vivelle, and CombiPatch.

Aventis Settles Pricing Fraud Case

Drugmaker Sanofi-Aventis has agreed to pay more than $190 million to settle allegations of fraudulent drug pricing and marketing against Aventis Pharmaceuticals, one of its predecessor companies. According to the U.S. Department of Justice, Aventis used the difference between the inflated prices that were used to set reimbursement rates and the actual prices charged to customers to market the antiemetic, Anzemet. In doing so, it caused fraudulent claims to be submitted to Medicare and other federal health care programs. The case arose after Ven-A-Care of the Florida Keys Inc. filed a False Claims Act suit, which allows a private person to file a whistle-blower suit on behalf of government. To continue working with federal programs, Sanofi-Aventis agreed to report accurate prices. Almost $180 million of the settlement will go to the federal government and the balance, to states and the District of Columbia. The whistle blowers will receive about $32 million.

Insurance Premium Increase Slows

Employer-sponsored health insurance premiums rose on average 6.1% in 2007, reflecting a continuing slowdown in premium increases. The 2007 premium increase is the smallest hike since 1999, according to an employer survey by the Kaiser Family Foundation and the Health Research and Educational Trust. But experts say the slowdown is likely temporary and isn't providing relief to individuals or employers. In fact, the 6.1% increase is higher than the average increase in wages (3.7%) and in the overall inflation rate (2.6%). In 2007, the average premium for family coverage in the United States is $12,106 with workers paying about $3,281 for their share of the policy. The market continues to be dominated by preferred provider organizations, which insure about 57% of covered workers; consumer-driven plans account for only about 5%. For details, visit

www.kff.org/insurance/7672

Rise in Adverse Drug Event Reports

The number of serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration more than doubled between 1998 and 2005, according to a report in the Sept. 10 issue of Archives of Internal Medicine. The agency defines a serious adverse event as an event resulting in death, a birth defect, disability, hospitalization, or that requires intervention. During the 8-year period, 467,809 serious events met the inclusion criteria. The number of reported serious ADEs increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label. Contrary to expectation, drugs related to safety withdrawals accounted for a “modest share” of reported events and declined over time. Of the 15 drugs most frequently cited in fatal events, there was a “disproportionate contribution of pain medications [7] and drugs that modify the immune system [4].” Drugs named in serious ADEs spanned a variety of classes, but within that group, events tied to 13 new biotechnology products increased almost 16-fold, from 580 in 1998 to 9,181 in 2005.

Bill Seeks MD Gift Disclosure

Legislation in the Senate would require quarterly disclosure of gifts, honoraria, travel, and other payments to physicians by pharmaceutical, medical device, and biotechnology manufacturers. S. 2029 was introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.) and would apply to manufacturers with more than $100 million in gross revenues. The U.S. Health and Human Services Department would be required to make the disclosure data available on the Internet. Penalties would range from $10,000 to $100,000 per violation. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his group had not yet reviewed the bill but that contact with physicians is essential for education purposes. The group's guidelines suggest gifts to physicians should not exceed $100. The American Medical Association had also not yet read the proposal, but in testimony earlier this year, noted that it has extensive guidelines on accepting anything from industry.

 

 

Mass. Considers Retail Clinic Rules

Massachusetts' Public Health Council is considering rules that would limit the scope of retail medical clinics in the state. The proposal is in response to a request by CVS Corp. to open 20–30 of its MinuteClinics in the Boston area beginning this fall. Under the proposal, applicants would need to: state what services they intend to provide; develop policies that limit the number of times each patient could receive care there; and refer patients without a primary care physician to one in the area who is accepting new patients.

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WHI Results Still Confusing

Just 18% of physicians said they have “no confusion at all” about the results of the Women's Health Initiative study, according to an online survey of more than 400 physicians conducted on behalf of the Hormone Foundation. Also, only 15% said they believe patients accurately understand the risks of hormone therapy. The results “underscore the importance of physicians' role in educating patients and [the public] on menopause management,” said foundation director Paula Correa. The survey, sponsored by Novogyne Pharmaceuticals, also found that 74% of physicians still consider hormone therapy as a first-line treatment for menopause symptoms. Novogyne manufactures the hormone therapy patches Vivelle-Dot, Vivelle, and CombiPatch.

Aventis Settles Pricing Fraud Case

Drugmaker Sanofi-Aventis has agreed to pay more than $190 million to settle allegations of fraudulent drug pricing and marketing against Aventis Pharmaceuticals, one of its predecessor companies. According to the U.S. Department of Justice, Aventis used the difference between the inflated prices that were used to set reimbursement rates and the actual prices charged to customers to market the antiemetic Anzemet. In doing so, it caused fraudulent claims to be submitted to Medicare and other federal health care programs. The case arose after Ven-A-Care of the Florida Keys Inc. filed a False Claims Act suit, which allows a private person to file a whistle-blower suit on behalf of government. To continue working with federal programs, Sanofi-Aventis agreed to report accurate prices. Almost $180 million of the settlement will go to the federal government, and the balance will go to states and the District of Columbia. The whistle-blowers will receive about $32 million.

Insurance Premium Increase Slows

Employer-sponsored health insurance premiums rose on average 6.1% in 2007, reflecting a continuing slowdown in premium increases. The 2007 premium increase is the smallest hike since 1999, according to an employer survey by the Kaiser Family Foundation and the Health Research and Educational Trust. But experts say the slowdown is likely temporary and isn't providing relief to individuals or employers. In fact, the 6.1% increase is higher than the average increase in wages (3.7%) and in the overall inflation rate (2.6%). In 2007, the average premium for family coverage in the United States is $12,106, with workers paying about $3,281 for their share of the policy. The market continues to be dominated by preferred provider organizations, which insure about 57% of covered workers; consumer-driven plans account for only about 5%. For details, visit

www.kff.org/insurance/7672

ACS Seeks to Improve Access

The American Cancer Society has launched a national campaign aimed at making access to health care for all Americans part of the national discussion and the number one priority of the next president. While the group is not advocating a specific plan, it has developed criteria for evaluating health care proposals. Under the principles developed by the American Cancer Society (ACS), the group defines “meaningful” health insurance coverage as adequate, affordable, available, and administratively simple. The idea is not just to provide access to cancer prevention, early detection, and treatment to the 47 million uninsured, but also to the tens of millions who are underinsured, John R. Seffrin, Ph.D., ACS chief executive officer, said during a news conference announcing the campaign. About 1 in 5 insured families touched by cancer will use up all or almost all of their life savings fighting the disease, he said. “For too many insured Americans, a cancer diagnosis is not only a personal health crisis, it is a prescription for financial ruin,” Dr. Seffrin said. The nationwide education campaign includes print and television advertisements, a Web site with information on how to take action, and grassroots activities by cancer activists. For more information, visit

www.cancer.org/access

Bill Seeks MD Gift Disclosure

Legislation in the Senate would require quarterly disclosure of gifts, honoraria, travel, and other payments to physicians by pharmaceutical, medical device, and biotechnology manufacturers. S. 2029 was introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.) and would apply to manufacturers with more than $100 million in gross revenues. The U.S. Health and Human Services Department would be required to make the disclosure data available on the Internet. Penalties would range from $10,000 to $100,000 per violation. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his group had not yet reviewed the bill but that contact with physicians is essential for education purposes. The group's guidelines suggest gifts to physicians should not exceed $100. The American Medical Association had also not yet read the proposal, but in testimony earlier this year, noted that it has extensive guidelines on accepting anything from industry.

 

 

Mass. Considers Retail Clinic Rules

Massachusetts' Public Health Council is considering rules that would limit the scope of retail medical clinics in the state. The proposal is in response to a request by CVS Corp. to open 20–30 of its MinuteClinics in the Boston area beginning this fall. Under the proposal, applicants would need to state what services they intend to provide, develop policies that limit the number of times each patient could receive care there, and refer patients without a primary care physician to one in the area who is accepting new patients.

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WHI Results Still Confusing

Just 18% of physicians said they have “no confusion at all” about the results of the Women's Health Initiative study, according to an online survey of more than 400 physicians conducted on behalf of the Hormone Foundation. Also, only 15% said they believe patients accurately understand the risks of hormone therapy. The results “underscore the importance of physicians' role in educating patients and [the public] on menopause management,” said foundation director Paula Correa. The survey, sponsored by Novogyne Pharmaceuticals, also found that 74% of physicians still consider hormone therapy as a first-line treatment for menopause symptoms. Novogyne manufactures the hormone therapy patches Vivelle-Dot, Vivelle, and CombiPatch.

Aventis Settles Pricing Fraud Case

Drugmaker Sanofi-Aventis has agreed to pay more than $190 million to settle allegations of fraudulent drug pricing and marketing against Aventis Pharmaceuticals, one of its predecessor companies. According to the U.S. Department of Justice, Aventis used the difference between the inflated prices that were used to set reimbursement rates and the actual prices charged to customers to market the antiemetic Anzemet. In doing so, it caused fraudulent claims to be submitted to Medicare and other federal health care programs. The case arose after Ven-A-Care of the Florida Keys Inc. filed a False Claims Act suit, which allows a private person to file a whistle-blower suit on behalf of government. To continue working with federal programs, Sanofi-Aventis agreed to report accurate prices. Almost $180 million of the settlement will go to the federal government, and the balance will go to states and the District of Columbia. The whistle-blowers will receive about $32 million.

Insurance Premium Increase Slows

Employer-sponsored health insurance premiums rose on average 6.1% in 2007, reflecting a continuing slowdown in premium increases. The 2007 premium increase is the smallest hike since 1999, according to an employer survey by the Kaiser Family Foundation and the Health Research and Educational Trust. But experts say the slowdown is likely temporary and isn't providing relief to individuals or employers. In fact, the 6.1% increase is higher than the average increase in wages (3.7%) and in the overall inflation rate (2.6%). In 2007, the average premium for family coverage in the United States is $12,106, with workers paying about $3,281 for their share of the policy. The market continues to be dominated by preferred provider organizations, which insure about 57% of covered workers; consumer-driven plans account for only about 5%. For details, visit

www.kff.org/insurance/7672

ACS Seeks to Improve Access

The American Cancer Society has launched a national campaign aimed at making access to health care for all Americans part of the national discussion and the number one priority of the next president. While the group is not advocating a specific plan, it has developed criteria for evaluating health care proposals. Under the principles developed by the American Cancer Society (ACS), the group defines “meaningful” health insurance coverage as adequate, affordable, available, and administratively simple. The idea is not just to provide access to cancer prevention, early detection, and treatment to the 47 million uninsured, but also to the tens of millions who are underinsured, John R. Seffrin, Ph.D., ACS chief executive officer, said during a news conference announcing the campaign. About 1 in 5 insured families touched by cancer will use up all or almost all of their life savings fighting the disease, he said. “For too many insured Americans, a cancer diagnosis is not only a personal health crisis, it is a prescription for financial ruin,” Dr. Seffrin said. The nationwide education campaign includes print and television advertisements, a Web site with information on how to take action, and grassroots activities by cancer activists. For more information, visit

www.cancer.org/access

Bill Seeks MD Gift Disclosure

Legislation in the Senate would require quarterly disclosure of gifts, honoraria, travel, and other payments to physicians by pharmaceutical, medical device, and biotechnology manufacturers. S. 2029 was introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.) and would apply to manufacturers with more than $100 million in gross revenues. The U.S. Health and Human Services Department would be required to make the disclosure data available on the Internet. Penalties would range from $10,000 to $100,000 per violation. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his group had not yet reviewed the bill but that contact with physicians is essential for education purposes. The group's guidelines suggest gifts to physicians should not exceed $100. The American Medical Association had also not yet read the proposal, but in testimony earlier this year, noted that it has extensive guidelines on accepting anything from industry.

 

 

Mass. Considers Retail Clinic Rules

Massachusetts' Public Health Council is considering rules that would limit the scope of retail medical clinics in the state. The proposal is in response to a request by CVS Corp. to open 20–30 of its MinuteClinics in the Boston area beginning this fall. Under the proposal, applicants would need to state what services they intend to provide, develop policies that limit the number of times each patient could receive care there, and refer patients without a primary care physician to one in the area who is accepting new patients.

WHI Results Still Confusing

Just 18% of physicians said they have “no confusion at all” about the results of the Women's Health Initiative study, according to an online survey of more than 400 physicians conducted on behalf of the Hormone Foundation. Also, only 15% said they believe patients accurately understand the risks of hormone therapy. The results “underscore the importance of physicians' role in educating patients and [the public] on menopause management,” said foundation director Paula Correa. The survey, sponsored by Novogyne Pharmaceuticals, also found that 74% of physicians still consider hormone therapy as a first-line treatment for menopause symptoms. Novogyne manufactures the hormone therapy patches Vivelle-Dot, Vivelle, and CombiPatch.

Aventis Settles Pricing Fraud Case

Drugmaker Sanofi-Aventis has agreed to pay more than $190 million to settle allegations of fraudulent drug pricing and marketing against Aventis Pharmaceuticals, one of its predecessor companies. According to the U.S. Department of Justice, Aventis used the difference between the inflated prices that were used to set reimbursement rates and the actual prices charged to customers to market the antiemetic Anzemet. In doing so, it caused fraudulent claims to be submitted to Medicare and other federal health care programs. The case arose after Ven-A-Care of the Florida Keys Inc. filed a False Claims Act suit, which allows a private person to file a whistle-blower suit on behalf of government. To continue working with federal programs, Sanofi-Aventis agreed to report accurate prices. Almost $180 million of the settlement will go to the federal government, and the balance will go to states and the District of Columbia. The whistle-blowers will receive about $32 million.

Insurance Premium Increase Slows

Employer-sponsored health insurance premiums rose on average 6.1% in 2007, reflecting a continuing slowdown in premium increases. The 2007 premium increase is the smallest hike since 1999, according to an employer survey by the Kaiser Family Foundation and the Health Research and Educational Trust. But experts say the slowdown is likely temporary and isn't providing relief to individuals or employers. In fact, the 6.1% increase is higher than the average increase in wages (3.7%) and in the overall inflation rate (2.6%). In 2007, the average premium for family coverage in the United States is $12,106, with workers paying about $3,281 for their share of the policy. The market continues to be dominated by preferred provider organizations, which insure about 57% of covered workers; consumer-driven plans account for only about 5%. For details, visit

www.kff.org/insurance/7672

ACS Seeks to Improve Access

The American Cancer Society has launched a national campaign aimed at making access to health care for all Americans part of the national discussion and the number one priority of the next president. While the group is not advocating a specific plan, it has developed criteria for evaluating health care proposals. Under the principles developed by the American Cancer Society (ACS), the group defines “meaningful” health insurance coverage as adequate, affordable, available, and administratively simple. The idea is not just to provide access to cancer prevention, early detection, and treatment to the 47 million uninsured, but also to the tens of millions who are underinsured, John R. Seffrin, Ph.D., ACS chief executive officer, said during a news conference announcing the campaign. About 1 in 5 insured families touched by cancer will use up all or almost all of their life savings fighting the disease, he said. “For too many insured Americans, a cancer diagnosis is not only a personal health crisis, it is a prescription for financial ruin,” Dr. Seffrin said. The nationwide education campaign includes print and television advertisements, a Web site with information on how to take action, and grassroots activities by cancer activists. For more information, visit

www.cancer.org/access

Bill Seeks MD Gift Disclosure

Legislation in the Senate would require quarterly disclosure of gifts, honoraria, travel, and other payments to physicians by pharmaceutical, medical device, and biotechnology manufacturers. S. 2029 was introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.) and would apply to manufacturers with more than $100 million in gross revenues. The U.S. Health and Human Services Department would be required to make the disclosure data available on the Internet. Penalties would range from $10,000 to $100,000 per violation. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his group had not yet reviewed the bill but that contact with physicians is essential for education purposes. The group's guidelines suggest gifts to physicians should not exceed $100. The American Medical Association had also not yet read the proposal, but in testimony earlier this year, noted that it has extensive guidelines on accepting anything from industry.

 

 

Mass. Considers Retail Clinic Rules

Massachusetts' Public Health Council is considering rules that would limit the scope of retail medical clinics in the state. The proposal is in response to a request by CVS Corp. to open 20–30 of its MinuteClinics in the Boston area beginning this fall. Under the proposal, applicants would need to state what services they intend to provide, develop policies that limit the number of times each patient could receive care there, and refer patients without a primary care physician to one in the area who is accepting new patients.

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