Elton hit with work restrictions; he must seek retractions from journals
By Ben Sutherly
The Columbus Dispatch
Originally published December 22, 2012
An Ohio State University pharmacy professor has agreed to request retractions of much of his research after university and government officials found that he falsified data in six journal articles.
As part of an agreement disclosed yesterday, Terry S. Elton said he will avoid contracting or subcontracting with any agency of the federal government for three years, or serving in any advisory capacity to the U.S. Public Health Service for three years. He will request that five of his scientific publications be retracted.
Federal and university investigations found that Elton falsified data from Western blots, a standard laboratory technique used to detect proteins. Some of Elton’s research explored the brain functions of people with Down syndrome.
The entire story is here.
Tuesday, January 8, 2013
Monday, January 7, 2013
Doctors Warned on ‘Divided Loyalty’
By
ROBERT PEAR
The New York
Times
Published:
December 26, 2012
With
hospitals buying up medical practices around the country and seeking to make
the most of their investment, the American Medical
Association reached out to doctors this week to remind them that patient
welfare must always come first and not be overridden by the economic interests
of hospitals that now employ doctors in ever-growing numbers.
“In
any situation where the economic or other interests of the employer are in
conflict with patient welfare, patient welfare must take priority,” says a
policy statement adopted by the association.
“A
physician’s paramount responsibility is to his or her patients,” the
association said. At the same time, it added, a doctor “owes a duty of loyalty
to his or her employer,” and “this divided loyalty can create conflicts of
interest, such as financial incentives to over- or under-treat patients.”
The
association is disseminating its policy to doctors at a time when more of them
are becoming hospital employees. About one-third of new doctors say they would
prefer to be employed by hospitals, rather than practice on their own. The
association is urging hospitals and medical groups to adopt similar policies.
A
major goal of the guidelines is to protect the professional autonomy of
doctors. Hospital employment agreements often include provisions that
discourage doctors from sending patients to providers of services that are not
affiliated with the hospital.
The
guidelines say that “physicians should always make treatment and referral
decisions based on the best interests of their patients.” Moreover, the
association says, patients should be told whenever a hospital provides
financial incentives that encourage, discourage or restrict referrals or
treatment options.
Sunday, January 6, 2013
State report blasts FAMU's effort to fight hazing before Champion's death
By Denise-Marie Ordway
Orlando Sentinel
Originally published December 28, 2012
FAMU lacked the internal controls needed to identify and fight hazing before the beating death of drum major Robert Champion in Orlando a year ago, according to a long-awaited investigative report released Friday afternoon.
The sharply critical report lays out a host of problems that the State University System found during its year-long investigation focusing on the university's failure to deter hazing in the years before Champion's death.
It comes just weeks after Florida A&M University's accrediting agency placed the school on probation for a year because of problems in areas such as student safety and school finances.
Derry Harper, the Inspector General for the university system's Board of Governors, reviewed hazing reports and FAMU's regulations between 2007 and 2011 to reach his conclusions. He discovered numerous failings, including poor communication between two key university departments and a lack of clear rules on how to handle hazing complaints.
Many of the hazing allegations investigated by campus police were never shared with the office that handles student discipline, even though some complaints might have prompted student disciplinary action. And nobody was tracking hazing on a campus that had been wrestling with the violent practice for decades.
The entire story is here.
Orlando Sentinel
Originally published December 28, 2012
FAMU lacked the internal controls needed to identify and fight hazing before the beating death of drum major Robert Champion in Orlando a year ago, according to a long-awaited investigative report released Friday afternoon.
The sharply critical report lays out a host of problems that the State University System found during its year-long investigation focusing on the university's failure to deter hazing in the years before Champion's death.
It comes just weeks after Florida A&M University's accrediting agency placed the school on probation for a year because of problems in areas such as student safety and school finances.
Derry Harper, the Inspector General for the university system's Board of Governors, reviewed hazing reports and FAMU's regulations between 2007 and 2011 to reach his conclusions. He discovered numerous failings, including poor communication between two key university departments and a lack of clear rules on how to handle hazing complaints.
Many of the hazing allegations investigated by campus police were never shared with the office that handles student discipline, even though some complaints might have prompted student disciplinary action. And nobody was tracking hazing on a campus that had been wrestling with the violent practice for decades.
The entire story is here.
Saturday, January 5, 2013
New tools to help providers protect patient data in mobile devices
U.S. Department of Health & Human Services
Press Release
December 12, 2012
Launched by the U.S. Department of Health and Human Services (HHS) today, a new education initiative and set of online tools provide health care providers and organizations practical tips on ways to protect their patients’ protected health information when using mobile devices such as laptops, tablets, and smartphones.
The initiative is called Mobile Devices: Know the RISKS. Take the STEPS. PROTECT and SECURE Health Information and is available at www.HealthIT.gov/mobiledevices. It offers educational resources such as videos, easy-to-download fact sheets, and posters to promote best ways to safeguard patient health information.
“The use of mobile health technology holds great promise in improving health and health care, but the loss of health information can have a devastating impact on the trust that patients have in their providers. It’s important that these tools are used correctly,” said Joy Pritts, HHS’ Office of the National Coordinator for Health Information Technology (ONC) chief privacy officer. “Health care providers, administrators and their staffs must create a culture of privacy and security across their organizations to ensure the privacy and security of their patients’ protected health information.”
Despite providers’ increasing use of using mobile technology for clinical use, research has shown that only 44 percent of survey respondents encrypt their mobile devices. Mobile device benefits—portability, size, and convenience—present a challenge when it comes to protecting and securing health information.
Along with theft and loss of devices, other risks, such as the inadvertent download of viruses or other malware, are top among reasons for unintentional disclosure of patient data to unauthorized users.
“We know that health care providers care deeply about patient trust and the importance of keeping health information secure and confidential,” said Leon Rodriguez, director of the HHS Office for Civil Rights. “This education effort and new online resource give health care providers common sense tools to help prevent their patients’ health information from falling into the wrong hands.”
For more information, tips, and steps on protecting and securing health information when using a mobile device visit www.HealthIT.gov/mobiledevices.
Press Release
December 12, 2012
Launched by the U.S. Department of Health and Human Services (HHS) today, a new education initiative and set of online tools provide health care providers and organizations practical tips on ways to protect their patients’ protected health information when using mobile devices such as laptops, tablets, and smartphones.
The initiative is called Mobile Devices: Know the RISKS. Take the STEPS. PROTECT and SECURE Health Information and is available at www.HealthIT.gov/mobiledevices. It offers educational resources such as videos, easy-to-download fact sheets, and posters to promote best ways to safeguard patient health information.
“The use of mobile health technology holds great promise in improving health and health care, but the loss of health information can have a devastating impact on the trust that patients have in their providers. It’s important that these tools are used correctly,” said Joy Pritts, HHS’ Office of the National Coordinator for Health Information Technology (ONC) chief privacy officer. “Health care providers, administrators and their staffs must create a culture of privacy and security across their organizations to ensure the privacy and security of their patients’ protected health information.”
Despite providers’ increasing use of using mobile technology for clinical use, research has shown that only 44 percent of survey respondents encrypt their mobile devices. Mobile device benefits—portability, size, and convenience—present a challenge when it comes to protecting and securing health information.
Along with theft and loss of devices, other risks, such as the inadvertent download of viruses or other malware, are top among reasons for unintentional disclosure of patient data to unauthorized users.
“We know that health care providers care deeply about patient trust and the importance of keeping health information secure and confidential,” said Leon Rodriguez, director of the HHS Office for Civil Rights. “This education effort and new online resource give health care providers common sense tools to help prevent their patients’ health information from falling into the wrong hands.”
For more information, tips, and steps on protecting and securing health information when using a mobile device visit www.HealthIT.gov/mobiledevices.
Friday, January 4, 2013
War Tragedies Strike Families Twice
By MICHAEL M. PHILLIPS
The Wall Street Journal
Originally published on December 20, 2012
One night in March 2008, William and Christine Koch opened their front door to see two soldiers in green dress uniforms bearing news that their son, Army Cpl. Steven Koch, had been killed by a suicide bomber in Afghanistan.
Two years later, Mr. and Mrs. Koch opened the door to see two police officers in blue. This time, they learned their daughter, Lynne, brokenhearted over her brother's death, had killed herself with an overdose of prescription drugs.
She is a casualty of this war, and I don't care what anybody says," Mrs. Koch said. "If my son was not killed, my daughter would be here."
The military tracks suicides among the troops. The Department of Veterans Affairs studies self-inflicted deaths among people who have left the service. Nobody collects data on suicides among the parents, siblings and spouses of the more than 6,500 Americans killed in Afghanistan and Iraq.
But anecdotal evidence from military families, support groups and suicide survivors suggests that over the past 11 years of war, the U.S. has experienced a little-recognized suicide outbreak among the bereaved. This second round of tragedy often takes place years after a loved one's death, when the finality of the loss becomes inescapable.
"We've all had the idea of suicide at one time or another," said Nadia McCaffrey of Tracy, Calif., whose son Patrick died in an ambush in Iraq in 2004. She said she personally knows a half dozen military parents who have killed themselves.
To learn more about war grief, researchers at the Uniformed Services University of the Health Sciences, a federal institution in Bethesda, Md., are recruiting 3,000 people to participate in a first-ever U.S. study of bereavement among families of those killed on active duty.
"We don't know whether or in what ways military-service deaths—combat-related, accidents or suicides—differ from similarly sudden or violent civilian deaths in their impact on bereaved family members," said Stephen Cozza, a psychiatrist involved in the research.
The violent and faraway nature of combat death—often following months of dread—may make it harder to accept for those left behind, said Bonnie Carroll. She founded the Tragedy Assistance Program for Survivors, or TAPS, after her husband, an Army general, died in a 1992 plane crash.
"To have someone come to the house and deliver this devastating information that you'd never see them again is impossible to absorb," Mrs. Carroll said. In her grief after her husband's death, she found herself taking high-speed, late-night drives along the Alaska coast, as if daring herself to join him.
The entire story is here.
Thursday, January 3, 2013
Reported sex assaults spike at military academies
By By LOLITA C. BALDOR
Associated Press
Originally published Dec 19, 2012
Reported sexual assaults at the nation's three military academies jumped by 23 percent overall this year, but the data signaled a continued reluctance by victims to seek criminal investigations.
According to a report obtained by The Associated Press, the number of assaults rose from 65 in the 2011 academic year to 80 in 2012. However, nearly half the assaults involved victims who sought confidential medical or other care and did not trigger an investigation. There were 41 assaults reported in 2010.
Reported sexual assaults have climbed steadily since the 2009 academic year. The Defense Department has urged the academies to take steps to encourage cadets and midshipmen at the Army, Navy and Air Force academies to report sexual harassment and assaults in order to get care to everyone and hold aggressors accountable. The number of assaults reported by the U.S. Military Academy at West Point, N.Y., and the U.S. Air Force Academy in Colorado Springs, Colo., increased, while reports at the U.S. Naval Academy in Annapolis, Md., declined.
The entire story is here.
Associated Press
Originally published Dec 19, 2012
Reported sexual assaults at the nation's three military academies jumped by 23 percent overall this year, but the data signaled a continued reluctance by victims to seek criminal investigations.
According to a report obtained by The Associated Press, the number of assaults rose from 65 in the 2011 academic year to 80 in 2012. However, nearly half the assaults involved victims who sought confidential medical or other care and did not trigger an investigation. There were 41 assaults reported in 2010.
Reported sexual assaults have climbed steadily since the 2009 academic year. The Defense Department has urged the academies to take steps to encourage cadets and midshipmen at the Army, Navy and Air Force academies to report sexual harassment and assaults in order to get care to everyone and hold aggressors accountable. The number of assaults reported by the U.S. Military Academy at West Point, N.Y., and the U.S. Air Force Academy in Colorado Springs, Colo., increased, while reports at the U.S. Naval Academy in Annapolis, Md., declined.
The entire story is here.
Wednesday, January 2, 2013
Mobile medical apps & FDA regulation
The Growth of the Health IT Sector and the Need for More Robust FDA Regulation
By Adam
Nurep
Originally posted on December 21, 2012
Over the last six years, there has been significant growth in the health technology sector (e.g. mobile medical apps), driven by advances in technology and an increase in venture capital (VC) funding. VCs have been lured into the space due to the perception of high returns on investment within shorter timeframes versus their traditional life science funds. The significant growth in this market has driven the need for increased scrutiny from the FDA in how these products should be regulated.
The FDA has the authority to regulate software if it falls within the broad definition of a “device”. It has further segmented medical devices into three classes; Class I, Class II and Class III. Class I devices don’t require FDA regulatory filing (i.e., 510(K), Premarket Approval Application (PMA)) whereas Class II requires 510(K) and Class III devices require a PMA. The class to which a device is assigned determines the type of premarketing submission/application required for FDA clearance, prior to product launch.
While the FDA has had policies in place for many years regarding the regulation of software/computer products, it has historically taken the position not to enforce the regulation unless the product interfaces directly with a medical device. In cases such as these, products have then been subjected to regulation as if they were a medical device. This caused problems for the manufacturers of these devices as there was no structured classification system based on a risk assessment, making it difficult to predict whether a device would end up being a Class I, II or III medical device. Furthermore, the rapid adoption of mobile technology within healthcare meant that there was a pressing need to develop specific guidelines around the regulation of these products also (out of the 14,558 medical apps currently available, only 75 have received clearance from the FDA).
The entire article is here.
By Adam
Nurep
Originally posted on December 21, 2012
Over the last six years, there has been significant growth in the health technology sector (e.g. mobile medical apps), driven by advances in technology and an increase in venture capital (VC) funding. VCs have been lured into the space due to the perception of high returns on investment within shorter timeframes versus their traditional life science funds. The significant growth in this market has driven the need for increased scrutiny from the FDA in how these products should be regulated.
The FDA has the authority to regulate software if it falls within the broad definition of a “device”. It has further segmented medical devices into three classes; Class I, Class II and Class III. Class I devices don’t require FDA regulatory filing (i.e., 510(K), Premarket Approval Application (PMA)) whereas Class II requires 510(K) and Class III devices require a PMA. The class to which a device is assigned determines the type of premarketing submission/application required for FDA clearance, prior to product launch.
While the FDA has had policies in place for many years regarding the regulation of software/computer products, it has historically taken the position not to enforce the regulation unless the product interfaces directly with a medical device. In cases such as these, products have then been subjected to regulation as if they were a medical device. This caused problems for the manufacturers of these devices as there was no structured classification system based on a risk assessment, making it difficult to predict whether a device would end up being a Class I, II or III medical device. Furthermore, the rapid adoption of mobile technology within healthcare meant that there was a pressing need to develop specific guidelines around the regulation of these products also (out of the 14,558 medical apps currently available, only 75 have received clearance from the FDA).
The entire article is here.
Effective and Ineffective Supervision
Nicholas Ladany, Yoko Mori, and Kristin E. Mehr
The Counseling Psychologist
January 2013 41: 28-47
First published on May 23, 2012
Abstract
Although supervision is recognized as a significant tenant of professional growth for counseling and psychotherapy students, the variability of the effectiveness, or ineffectiveness, of supervision has come under scrutiny in recent times. Our sample of 128 participants shed light on the most effective (e.g., encouraged autonomy, strengthened the supervisory relationship, and facilitated open discussion) and most ineffective (e.g., depreciated supervision, performed ineffective client conceptualization and treatment, and weakened the supervisory relationship) supervisor skills, techniques, and behaviors. Moreover, effective and ineffective behaviors, along with best and worst supervisors, were significantly differentiated based on the supervisory working alliance, supervisor style, supervisor self-disclosure, supervisee nondisclosure, and supervisee evaluation. Implications for supervision competencies and supervisor accountability are discussed.
The entire article can be found here.
A presentation by Nicholas Ladany on effective supervision can be found in the PowerPoint Vault on this blog.
Tuesday, January 1, 2013
CLEANING UP SCIENCE
BY GARY MARCUS
The New Yorker
Originally published December 24, 2012
A lot of scientists have been busted recently for making up data and fudging statistics. One case involves a Harvard professor who I once knew and worked with; another a Dutch social psychologist who made up results by the bushel. Medicine, too, has seen a rash of scientific foul play; perhaps most notably, the dubious idea that vaccines could cause autism appears to have been a hoax perpetrated by a scientific cheat. A blog called RetractionWatch publishes depressing notices, almost daily. One recent post mentioned that a peer-review site had been hacked; others detail misconduct in dentistry, cancer research, and neuroscience. And that’s just in the last week.
Even if cases of scientific fraud and misconduct were simply ignored, my field (and several other fields of science, including medicine) would still be in turmoil. One recent examination of fifty-three medical studies found that further research was unable to replicate forty-seven of them. All too often, scientists muck about with pilot studies, and keep tweaking something until they get the result they were hoping to achieve. Unfortunately, each fresh effort increases the risk of getting the right result for the wrong reason, and winding up with a spurious vision of something that doesn’t turn out to be scientifically robust, like a cancer drug that seems to work in trials but fails to work in the real world
How on Earth are we going to do better? Here are six suggestions, drawn mainly from a just-published special issue of the journal Perspectives on Psychological Science. Two dozen articles offer valuable lessons not only for psychology, but for all consumers and producers of experimental science, from physics to neuroscience to medicine.
Restructure the incentives in science. For many reasons, science has become a race for the swift, but not necessarily the careful. Grants, tenure, and publishing all depend on flashy, surprising results. It is difficult to publish a study that merely replicates a predecessor, and it’s difficult to get tenure (or grants, or a first faculty jobs) without publications in elite journals. From the time a young scientist starts a Ph. D. to the time they’re up for tenure is typically thirteen years (or more), at the end of which the no-longer young apprentice might find him or herself out of a job. It is perhaps, in hindsight, no small wonder that some wind up cutting corners. Instead of, for example, rewarding scientists largely for the number of papers they publish—which credits quick, sloppy results that might not be reliable—we might reward scientists to a greater degree for producing solid, trustworthy research that other people are able to successfully replicate and then extend.
The entire article is here.
The New Yorker
Originally published December 24, 2012
A lot of scientists have been busted recently for making up data and fudging statistics. One case involves a Harvard professor who I once knew and worked with; another a Dutch social psychologist who made up results by the bushel. Medicine, too, has seen a rash of scientific foul play; perhaps most notably, the dubious idea that vaccines could cause autism appears to have been a hoax perpetrated by a scientific cheat. A blog called RetractionWatch publishes depressing notices, almost daily. One recent post mentioned that a peer-review site had been hacked; others detail misconduct in dentistry, cancer research, and neuroscience. And that’s just in the last week.
Even if cases of scientific fraud and misconduct were simply ignored, my field (and several other fields of science, including medicine) would still be in turmoil. One recent examination of fifty-three medical studies found that further research was unable to replicate forty-seven of them. All too often, scientists muck about with pilot studies, and keep tweaking something until they get the result they were hoping to achieve. Unfortunately, each fresh effort increases the risk of getting the right result for the wrong reason, and winding up with a spurious vision of something that doesn’t turn out to be scientifically robust, like a cancer drug that seems to work in trials but fails to work in the real world
How on Earth are we going to do better? Here are six suggestions, drawn mainly from a just-published special issue of the journal Perspectives on Psychological Science. Two dozen articles offer valuable lessons not only for psychology, but for all consumers and producers of experimental science, from physics to neuroscience to medicine.
Restructure the incentives in science. For many reasons, science has become a race for the swift, but not necessarily the careful. Grants, tenure, and publishing all depend on flashy, surprising results. It is difficult to publish a study that merely replicates a predecessor, and it’s difficult to get tenure (or grants, or a first faculty jobs) without publications in elite journals. From the time a young scientist starts a Ph. D. to the time they’re up for tenure is typically thirteen years (or more), at the end of which the no-longer young apprentice might find him or herself out of a job. It is perhaps, in hindsight, no small wonder that some wind up cutting corners. Instead of, for example, rewarding scientists largely for the number of papers they publish—which credits quick, sloppy results that might not be reliable—we might reward scientists to a greater degree for producing solid, trustworthy research that other people are able to successfully replicate and then extend.
The entire article is here.
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