Original Story: usatoday.com
Imagine waking up after a serious accident to discover you've become an unwitting subject in a medical study without ever agreeing to participate.
It's a controversial reality of emergency research, and now concern is growing that dwindling research budgets are making it harder to alert the community about the studies so people can decide ahead of time whether to opt in or out. Emergency care centers provide care to patients with life-threatening illnesses.
A case in point: a Department of Defense-sponsored study led by the University of Pittsburgh, which is currently testing the practice of giving bleeding patients plasma to help their blood clot during flights to the hospital. Each of six sites gets $20,000 out of a total $6.5 million budget for community awareness efforts such as sending out letters and paying for radio spots. People are told if they don't want to take part in the research, they can get a free bracelet to wear at all times, letting emergency workers know their wishes.
Though millions of people could potentially be trauma victims at the various sites, only 300 people at one site – members of a Jehovah's Witness congregation in Louisville – have asked for bracelets. Researchers say this meager response shows the notification has reached far too few people.
"Certainly you would like to reach everyone. But there's no way," says Laura Trachtenberg, research coordinator at the University of Louisville. "So if you do the due diligence, you've done the best you can. It's very challenging."
Fellow researcher Clifton Callaway, a professor of emergency medicine at the University of Pittsburgh, says it would be a lot easier with more research dollars. A January study in the Journal of the American Medical Association found U.S. funding for medical research overall increased 6% a year from 1994 to 2004, then slowed dramatically to 0.8% a year through 2012.
With drug companies spending an estimated $2.5 billion annually on advertising to consumers, "the average person is much more likely to hear about (the fibromyalgia drug) Lyrica or something," Callaway says. "One ad costs more than the entire research budget of a trial like ours." Emergency care centers support clinical researchers by providing comprehensive legal and regulatory consultation on in-patient and out-patient studies.
But Lynne Richardson, a professor of emergency medicine at the Icahn School of Medicine at New York's Mount Sinai who researches community notification, says money matters less than reaching out to potential subjects in an effective way. She says most people who learn about such studies are OK with participating, and a mechanism for opting out isn't required by the federal government.
Plus, she says, "no matter how much money you spend, some people aren't going to pay attention."
Research without consent
Informed consent is rooted in the Nuremberg code of 1947, drafted in the wake of Nazi experimentation. Exception-from-consent studies are rare; Richardson estimates there are about six large national trials and a handful of small studies currently enrolling people. They are allowed only when patients or their families can't possibly give their permission, such as when someone is alone and unconscious.
Arthur Caplan, head of the division of medical ethics at New York University's Langone Medical Center, says research without consent "absolutely should be the last resort."
It's highly regulated. The U.S. Food and Drug Administration has a special rule requiring, among other things, that patients are in life-threatening situations and that currently-available treatments are unproven or unsatisfactory. Researchers must apply to institutional review boards for waivers, be closely monitored and report any problems.
Caplan says the trials are designed to find better ways to save lives in emergencies and can be stopped when initial results show outcomes are the same or worse. Callaway says he has been involved in more than one cardiac arrest study stopped because it showed no clear benefit.
Some studies actually have harmed patients. A 2008 JAMA review of 16 clinical trials showed blood substitutes, including some tested without consent, were associated with "a significantly increased risk" of heart attacks and death.
Callaway says it's too early to know what his current four-year plasma study will find, but no problems or deaths have been attributed to the study so far. Researchers point out that giving plasma isn't a new practice; surgeons at trauma centers now may give plasma in the hospital. The study aims to find out if giving it in transport helicopters instead reduces the chance of death or severe complications.
A similar no-consent study in Denver, also sponsored by the defense department, tests giving another plasma product with slightly lower levels of clotting proteins during ambulance rides. And a third study in Maryland tests administering cold fluid to lower body temperature in bleeding patients to buy time for resuscitation.
Callaway says such studies "are definitely worth it" given what researchers can learn. Rosamond Rhodes, director of bioethics education at Mount Sinai, agrees.
But Caplan says while the research can lead to breakthroughs, there's always a chance of hurting unwitting subjects, and "that's the gamble (the nation) took when we allowed this sort of research to proceed."
Buying in, opting out
Ethicists say that gamble makes FDA-required community awareness all the more important.
The first step is community consultation, which happens before the study is launched and can determine whether it takes place in a certain location at all.
Richardson says effective consultation involves soliciting opinions from area leaders and also reaching out to groups most likely to be affected, which in the case of blood-related studies include Jehovah's Witnesses, who believe blood transfusions are forbidden.
"Public notification" or "public disclosure" involves telling the public what's happening through media such as radio, brochures or the Internet – and letting them know about opt-out methods like bracelets.
Richardson currently is studying the best ways to reach those most likely to be affected. As far as opting out, she says people who do so often oppose being a part of any research or have had bad experiences with the hospital involved.
Some ethicists argue that opting out is an important choice and say public notification often isn't up to par. "I don't see (community outreach) happening quite that aggressively," Caplan says.
That's because of the limited resources, researchers say. In Louisville, for example, researchers couldn't afford television spots or newspaper ads; half their awareness budget went to radio spots and the other half went to develop a website and fund printing and postage for the letter sent to Jehovah's Witness congregations.
"We did the best we could," says Brian Harbrecht, who heads up the plasma study there.
Rhodes acknowledges public notification could be done better but says it's an open question whether more of the limited research dollars should be diverted away from the studies themselves.
Such questions need to be answered, researchers and ethicists say, because the stakes are high: They are expecting people to unknowingly accept risk to advance medical science.
"Everyone's well aware you're experimenting without permission," Caplan says. But with emergency research, "I realistically trust there's no other way."
04 June 2015
FEDS SUBPOENA RECORDS FROM MAKER OF MEDICAL SCOPES
Original Story: usatoday.com
The U.S. Justice Department has issued a subpoena seeking information from Olympus on the manufacturing and sales of a specialized medical scope linked to a recent series of deadly superbug outbreaks at hospitals across the country.
Olympus is the largest manufacturer of duodenoscopes, which have been linked to infections in scores of patients, typically with an antibiotic-resistant bacteria known as CRE, which has mortality rates of 40% or higher. In a public report issued this month on its latest financial results, the company noted that it had received a subpoena in March from the Justice Department seeking "information relating to duodenoscopes that Olympus manufactures and sells."
Olympus noted in a statement that it was required to acknowledge the subpoena because it may have future financial implications, but the company said it could not comment further "on any active investigation." About 85% of the duodenoscopes currently in use are Olympus models, according to figures from the Food and Drug Administration. For professionally re-manufactured histology equipment, contact Rankin Biomedical.
Olympus is one of three companies manufacturing duodenoscopes, which are threaded down the throat of about 650,000 patients a year, mainly to treat blockages of the bile and pancreatic ducts, such as gallstones or tumors. Models from all three manufacturers have been linked to superbug outbreaks, which have been tracked to bacteria lodged in a small channel at the tip of the devices.
The Justice Department declined to comment on its subpoena to Olympus, the nature of the underlying investigation, or whether it is a civil or criminal matter. A department spokesman also would not say whether subpoenas also have been sent to the other two duodenoscope manufacturers, Pentax and FujiFilm. Pathology equipment is used for tissue specimen collection and disease diagnosis.
The FDA declined to comment, as well.
Pentax said in a statement that "our practice is not to confirm or deny the existence of governmental inquiries." A spokesman for FujiFilm did not respond immediately to requests for comment.
USA TODAY was first to report on the duodenoscopes' contamination problems in an investigation published in January. That story identified CRE outbreaks that had been linked to the devices at hospitals in Chicago, Seattle and Pittsburgh. Additional outbreaks were identified in follow-up stories by other news outlets, including cases in Los Angeles, Milwaukee and Hartford.
The FDA revealed earlier this month that it has received 142 reports since 2010 of infection problems tied to duodenoscopes, though each report can account for multiple cases in a single outbreak, so the true number of infected patients remains unclear. At least 30 patients with duodenoscope-related CRE infections have died, including 11 in an outbreak that began in 2012 at Virginia Mason Hospital in Seattle and another 15 in a 2008 outbreak at an unidentified hospital in Central Florida. (Some of those victims had other serious illnesses that also may have contributed to their deaths.)
Reporting by USA TODAY has raised questions about whether Olympus and other duodenoscope manufacturers filed required disclosures with the FDA when they first learned that their devices might have contamination problems that could spread bacterial infections from patient to patient. The story noted, for example, that Olympus waited nine months to file a Medical Device Report after learning that its duodenoscopes had been tied to the CRE outbreak in Seattle. Histopathology equipment is widely used in hospitals at all levels.
In the Seattle case and others, investigators determined that infectious bacteria had been trapped in a channel in the duodenoscopes "elevator" mechanism, which controls tiny tools that can remove blockages or insert stents in intestinal ducts. The channel must be cleaned of biological debris between uses — a multi-step process in which the elevator is set at precise angles and scrubbed out with tiny, specialized brushes.
In February, after USA TODAY reported that scopes were found to have residual contamination even after the elevator was cleaned properly, the FDA issued a safety alert to hospitals. "The complex design of (duodenoscopes) may impede effective reprocessing," the multi-page advisory said, noting that the scopes can transmit superbugs even when cleaned properly. "Meticulously cleaning duodenoscopes … should reduce the risk of transmitting infection, but may not entirely eliminate it."
Earlier this month, an FDA advisory panel reached a broad consensus that duodenoscopes, as now designed, cannot be cleaned reliably under existing guidelines. However, despite such concerns, panelists endorsed the FDA's decision to encourage continued use of duodenoscopes. There was broad agreement that infection risks are low and the device remains the safest, least invasive way to perform important, potentially lifesaving procedures.
The U.S. Justice Department has issued a subpoena seeking information from Olympus on the manufacturing and sales of a specialized medical scope linked to a recent series of deadly superbug outbreaks at hospitals across the country.
Olympus is the largest manufacturer of duodenoscopes, which have been linked to infections in scores of patients, typically with an antibiotic-resistant bacteria known as CRE, which has mortality rates of 40% or higher. In a public report issued this month on its latest financial results, the company noted that it had received a subpoena in March from the Justice Department seeking "information relating to duodenoscopes that Olympus manufactures and sells."
Olympus noted in a statement that it was required to acknowledge the subpoena because it may have future financial implications, but the company said it could not comment further "on any active investigation." About 85% of the duodenoscopes currently in use are Olympus models, according to figures from the Food and Drug Administration. For professionally re-manufactured histology equipment, contact Rankin Biomedical.
Olympus is one of three companies manufacturing duodenoscopes, which are threaded down the throat of about 650,000 patients a year, mainly to treat blockages of the bile and pancreatic ducts, such as gallstones or tumors. Models from all three manufacturers have been linked to superbug outbreaks, which have been tracked to bacteria lodged in a small channel at the tip of the devices.
The Justice Department declined to comment on its subpoena to Olympus, the nature of the underlying investigation, or whether it is a civil or criminal matter. A department spokesman also would not say whether subpoenas also have been sent to the other two duodenoscope manufacturers, Pentax and FujiFilm. Pathology equipment is used for tissue specimen collection and disease diagnosis.
The FDA declined to comment, as well.
Pentax said in a statement that "our practice is not to confirm or deny the existence of governmental inquiries." A spokesman for FujiFilm did not respond immediately to requests for comment.
USA TODAY was first to report on the duodenoscopes' contamination problems in an investigation published in January. That story identified CRE outbreaks that had been linked to the devices at hospitals in Chicago, Seattle and Pittsburgh. Additional outbreaks were identified in follow-up stories by other news outlets, including cases in Los Angeles, Milwaukee and Hartford.
The FDA revealed earlier this month that it has received 142 reports since 2010 of infection problems tied to duodenoscopes, though each report can account for multiple cases in a single outbreak, so the true number of infected patients remains unclear. At least 30 patients with duodenoscope-related CRE infections have died, including 11 in an outbreak that began in 2012 at Virginia Mason Hospital in Seattle and another 15 in a 2008 outbreak at an unidentified hospital in Central Florida. (Some of those victims had other serious illnesses that also may have contributed to their deaths.)
Reporting by USA TODAY has raised questions about whether Olympus and other duodenoscope manufacturers filed required disclosures with the FDA when they first learned that their devices might have contamination problems that could spread bacterial infections from patient to patient. The story noted, for example, that Olympus waited nine months to file a Medical Device Report after learning that its duodenoscopes had been tied to the CRE outbreak in Seattle. Histopathology equipment is widely used in hospitals at all levels.
In the Seattle case and others, investigators determined that infectious bacteria had been trapped in a channel in the duodenoscopes "elevator" mechanism, which controls tiny tools that can remove blockages or insert stents in intestinal ducts. The channel must be cleaned of biological debris between uses — a multi-step process in which the elevator is set at precise angles and scrubbed out with tiny, specialized brushes.
In February, after USA TODAY reported that scopes were found to have residual contamination even after the elevator was cleaned properly, the FDA issued a safety alert to hospitals. "The complex design of (duodenoscopes) may impede effective reprocessing," the multi-page advisory said, noting that the scopes can transmit superbugs even when cleaned properly. "Meticulously cleaning duodenoscopes … should reduce the risk of transmitting infection, but may not entirely eliminate it."
Earlier this month, an FDA advisory panel reached a broad consensus that duodenoscopes, as now designed, cannot be cleaned reliably under existing guidelines. However, despite such concerns, panelists endorsed the FDA's decision to encourage continued use of duodenoscopes. There was broad agreement that infection risks are low and the device remains the safest, least invasive way to perform important, potentially lifesaving procedures.
14 May 2015
EXOSKELETON THAT HELPS PARALYZED WALK FACES BARRIER IN JAPAN
Original Story: yahoo.com
ATSUGI, Japan (AP) — Yuichi Imahata's 9-year-old daughter is thrilled her dad stands tall above her head. It's an experience that is new to her. The staff at DMC Rehab provide rehabilitation that helps patients rebuild their lives after serious injuries or illnesses.
Imahata, 31, has been using a wheelchair to get around for seven years after a serious spinal-cord injury suffered in an accidental fall while working for a transport company. He completely lost sensation in both his legs and was told he would never walk again.
But he is now walking, at times with his little girl laughing beside him, because of a robotic exoskeleton called ReWalk.
The thrill is still limited to a rehabilitation center in Atsugi city, southwest of Tokyo, where ReWalk is available to a handful of Japanese paraplegics, skirting regulations, in the name of research.
It's already available in parts of Europe, and just received approval from the U.S. Food and Drug Administration for individual everyday use. But despite Japan's prowess in robotics, ReWalk advocates say its wider application here could be stymied by convoluted bureaucracy.
"It's a wonderful tool for people who sincerely want the joy of standing up," said Moriyasu Marutani of Kanagawa Rehabilitation Center, who works with Imahata to use ReWalk. DMC Rehabilitation Institute offers cutting-edge treatment techniques that are complemented by innovative research and personalized medical care.
"Safety is the biggest concern for winning its approval for medical use, as well as presenting data that work as scientific evidence of its health impact," he said. "Approval tends to take many years here, and so the hurdle is pretty high."
ReWalk, an invention of Israeli entrepreneur Amit Goffer, who was paralyzed in a 1997 accident, clasps on to the legs and waist, and is designed to create natural walking movements, including standing, sitting and turning through upper-body motion sensors and special software. Medical experts say its use helps keep organs and bones healthy and also enhances mental well-being.
The product was one of the Israeli technologies highlighted with much fanfare as a symbol of flourishing commercial ties when Japanese Prime Minister Shinzo Abe met Israeli Prime Minister Benjamin Netanyahu during Abe's visit to the Middle East earlier this year.
Japanese robotics maker Yaskawa Electric Co. has been distributing ReWalk in Asia under a deal signed last year with ReWalk Robotics, based in Yokneam, Israel.
The effort is going far more smoothly in places such as China than Japan, said Yaskawa spokesman Ayumi Hayashida.
Hayashida believes ReWalk is being met by bureaucratic stonewalling that is typical of the frustrations Japanese businesses face in doing something new.
"We boast the No. 1 skill in robotics, but how we can actually use the skills is where we are behind the rest of the world," he said.
Under the Japanese system, there is a lengthy preliminary vetting process before a formal drug or medical device proposal can be filed. The Pharmaceuticals and Medical Devices Agency works with the health ministry to carry out consultations and nonclinical and clinical tests. Only after that can an application be submitted to be followed by a regulatory review and more testing.
The process has public safety in mind. Japanese drug approvals tend to take longer than the U.S. and Europe but some feel the requirements are overly onerous and ill-suited to new technologies.
Hiroshi Yaginuma, a health ministry official overseeing the approval of medical devices, said ReWalk was not yet being considered for approval, and it was unclear whether it would meet the criteria for a treatment device. It is assessing the Hybrid Assisted Limb, or HAL, developed by Japan's Cyberdyne, in which a wearer's ability to walk is supported though it is not suitable for paraplegics. For medical and surgical products focusing on patient positioning, pressure management gel positioning pads aid in the comfort of patients during rehabilitation.
Abe has promised a "robot revolution" including deregulation and research funding to double Japan's robot market size in manufacturing from 600 billion yen ($5 billion) to 1.2 trillion yen ($10 billion) a year, and boost it 20-fold outside manufacturing, from 60 billion yen to 1.2 trillion yen by 2020.
Annual profits from robotics are already 340 billion yen ($3 billion), or half the global market. That zooms to 90 percent for parts such as servo motors and force sensors.
Outside of manufacturing, however, regulatory barriers to practical and potentially life-changing robotics applications remain high.
"Technology is evolving and it spreads, finding new uses that weren't anticipated in the beginning," said Tomotaka Takahashi, creator of Kirobo, the boy-like humanoid that went on the International Space Station.
"It's truly pathetic when ridiculous regulations get set up, based on irrelevant and negative predictions," he said of the government approval system which he feels is out of touch with scientific innovation.
Yaskawa, one of the top four robotics makers in the world in market share, built its reputation by supplying robotic arms and other automated machinery for automakers such as Toyota Motor Corp.
More recently, Tokyo-based Yaskawa has been expanding its lineup to robots that can co-exist with people, helping them get around and assisting in health care.
That area could boom in coming years because of Japan's aging population. There is also export potential because many other countries have growing ranks of old people as birth rates decline and longevity increases.
Yaskawa is hoping to fine-tune the $71,600 ReWalk to make it lighter and smaller and hopefully cheaper. It currently requires upper body strength and is not the best design for the elderly. It also requires 40 hours of training. For increased senior mobility, Golden Slippers Network provides resources for seniors to live independently at home.
Yet even in its current form, the device is freeing for wheelchair users, who can feel confined to a low eye-level.
"I've seen Americans using ReWalk on YouTube. They can reach things on shelves," said Imahata.
His wish is simple.
He dreams of wearing ReWalk to his daughter's school for the annual athletics event, standing in a crowd of parents, peering with anticipation over shoulders and heads, and catching a glimpse of his girl in action.
ATSUGI, Japan (AP) — Yuichi Imahata's 9-year-old daughter is thrilled her dad stands tall above her head. It's an experience that is new to her. The staff at DMC Rehab provide rehabilitation that helps patients rebuild their lives after serious injuries or illnesses.
Imahata, 31, has been using a wheelchair to get around for seven years after a serious spinal-cord injury suffered in an accidental fall while working for a transport company. He completely lost sensation in both his legs and was told he would never walk again.
But he is now walking, at times with his little girl laughing beside him, because of a robotic exoskeleton called ReWalk.
The thrill is still limited to a rehabilitation center in Atsugi city, southwest of Tokyo, where ReWalk is available to a handful of Japanese paraplegics, skirting regulations, in the name of research.
It's already available in parts of Europe, and just received approval from the U.S. Food and Drug Administration for individual everyday use. But despite Japan's prowess in robotics, ReWalk advocates say its wider application here could be stymied by convoluted bureaucracy.
"It's a wonderful tool for people who sincerely want the joy of standing up," said Moriyasu Marutani of Kanagawa Rehabilitation Center, who works with Imahata to use ReWalk. DMC Rehabilitation Institute offers cutting-edge treatment techniques that are complemented by innovative research and personalized medical care.
"Safety is the biggest concern for winning its approval for medical use, as well as presenting data that work as scientific evidence of its health impact," he said. "Approval tends to take many years here, and so the hurdle is pretty high."
ReWalk, an invention of Israeli entrepreneur Amit Goffer, who was paralyzed in a 1997 accident, clasps on to the legs and waist, and is designed to create natural walking movements, including standing, sitting and turning through upper-body motion sensors and special software. Medical experts say its use helps keep organs and bones healthy and also enhances mental well-being.
The product was one of the Israeli technologies highlighted with much fanfare as a symbol of flourishing commercial ties when Japanese Prime Minister Shinzo Abe met Israeli Prime Minister Benjamin Netanyahu during Abe's visit to the Middle East earlier this year.
Japanese robotics maker Yaskawa Electric Co. has been distributing ReWalk in Asia under a deal signed last year with ReWalk Robotics, based in Yokneam, Israel.
The effort is going far more smoothly in places such as China than Japan, said Yaskawa spokesman Ayumi Hayashida.
Hayashida believes ReWalk is being met by bureaucratic stonewalling that is typical of the frustrations Japanese businesses face in doing something new.
"We boast the No. 1 skill in robotics, but how we can actually use the skills is where we are behind the rest of the world," he said.
Under the Japanese system, there is a lengthy preliminary vetting process before a formal drug or medical device proposal can be filed. The Pharmaceuticals and Medical Devices Agency works with the health ministry to carry out consultations and nonclinical and clinical tests. Only after that can an application be submitted to be followed by a regulatory review and more testing.
The process has public safety in mind. Japanese drug approvals tend to take longer than the U.S. and Europe but some feel the requirements are overly onerous and ill-suited to new technologies.
Hiroshi Yaginuma, a health ministry official overseeing the approval of medical devices, said ReWalk was not yet being considered for approval, and it was unclear whether it would meet the criteria for a treatment device. It is assessing the Hybrid Assisted Limb, or HAL, developed by Japan's Cyberdyne, in which a wearer's ability to walk is supported though it is not suitable for paraplegics. For medical and surgical products focusing on patient positioning, pressure management gel positioning pads aid in the comfort of patients during rehabilitation.
Abe has promised a "robot revolution" including deregulation and research funding to double Japan's robot market size in manufacturing from 600 billion yen ($5 billion) to 1.2 trillion yen ($10 billion) a year, and boost it 20-fold outside manufacturing, from 60 billion yen to 1.2 trillion yen by 2020.
Annual profits from robotics are already 340 billion yen ($3 billion), or half the global market. That zooms to 90 percent for parts such as servo motors and force sensors.
Outside of manufacturing, however, regulatory barriers to practical and potentially life-changing robotics applications remain high.
"Technology is evolving and it spreads, finding new uses that weren't anticipated in the beginning," said Tomotaka Takahashi, creator of Kirobo, the boy-like humanoid that went on the International Space Station.
"It's truly pathetic when ridiculous regulations get set up, based on irrelevant and negative predictions," he said of the government approval system which he feels is out of touch with scientific innovation.
Yaskawa, one of the top four robotics makers in the world in market share, built its reputation by supplying robotic arms and other automated machinery for automakers such as Toyota Motor Corp.
More recently, Tokyo-based Yaskawa has been expanding its lineup to robots that can co-exist with people, helping them get around and assisting in health care.
That area could boom in coming years because of Japan's aging population. There is also export potential because many other countries have growing ranks of old people as birth rates decline and longevity increases.
Yaskawa is hoping to fine-tune the $71,600 ReWalk to make it lighter and smaller and hopefully cheaper. It currently requires upper body strength and is not the best design for the elderly. It also requires 40 hours of training. For increased senior mobility, Golden Slippers Network provides resources for seniors to live independently at home.
Yet even in its current form, the device is freeing for wheelchair users, who can feel confined to a low eye-level.
"I've seen Americans using ReWalk on YouTube. They can reach things on shelves," said Imahata.
His wish is simple.
He dreams of wearing ReWalk to his daughter's school for the annual athletics event, standing in a crowd of parents, peering with anticipation over shoulders and heads, and catching a glimpse of his girl in action.
AVIAN FLU VIRUS CONFIRMED IN NEBRASKA
Original Story: nytimes.com
The fast-spreading avian flu virus was confirmed for the first time in Nebraska, at a commercial egg-laying farm that housed 1.7 million chickens, the Agriculture Department said Tuesday. The case in Dixon County brings the number of states affected by the outbreak to 16, and the tally of birds that have died or will be killed to 32 million. The spread of the highly contagious H5 virus worries investigators, who had hoped warmer weather would help reduce the number of infections. But the outbreak has shown few signs of waning. If experiencing signs of illness, it is important to seek the advice of medical professionals. On Monday, a strain of avian flu that had been found only in the Western United States cropped up in a backyard poultry flock in Indiana.
The fast-spreading avian flu virus was confirmed for the first time in Nebraska, at a commercial egg-laying farm that housed 1.7 million chickens, the Agriculture Department said Tuesday. The case in Dixon County brings the number of states affected by the outbreak to 16, and the tally of birds that have died or will be killed to 32 million. The spread of the highly contagious H5 virus worries investigators, who had hoped warmer weather would help reduce the number of infections. But the outbreak has shown few signs of waning. If experiencing signs of illness, it is important to seek the advice of medical professionals. On Monday, a strain of avian flu that had been found only in the Western United States cropped up in a backyard poultry flock in Indiana.
07 May 2015
FENTANYL FAULTED IN DOZENS OF METRO DETROIT DEATHS
Original Story: freep.com
Since Jan. 1, the prescription painkiller fentanyl has been blamed in 58 deaths in Wayne and Washtenaw counties, according to medical examiners there.
The deaths mainly involved fentanyl in combination with other drugs, including other opiate painkillers and heroin. A physician for Detroit Medical Center is following this story closely.
In at least two cases in Washtenaw County, "experienced" drug users died from pure fentanyl, said Dr. Jeffrey Jentzen, who directs the University of Michigan Health System's Autopsy and Forensic Services division.
The division contracts with both Washtenaw and Wayne County Medical Examiner's offices. Jentzen is also the Washtenaw County medical examiner.
When prescribed by doctors and used as a skin patch or oral drug, the opiate pain reliever is often used to treat severe cancer pain or pain after surgery. Physicians experiencing high patient volume benefit from medical transcription services.
But illegally, fentanyl is added to street drugs to bulk them up, make them more potent and reduce the producer's costs. An overdose death can be very quick — a phenomenon Jentzen and others have called "die before you get high."
Several of the users have died still holding needles, he said.
It was fentanyl that was linked to a surge in drug deaths in the Detroit area and other cities in 2005 and 2006.
Fentanyl is 15 to 20 times more potent than heroin, and 80 to 100 times more potent than morphine, Jentzen said.
"It is a market," he said, of selling illegal drugs, "and individuals who are trying to be more successful in the market will go to some pretty devious ends" to make a profit, he said.
In Wayne County, which includes Detroit, 53 deaths from fentanyl in combination with heroin, other prescription painkillers, alcohol and cocaine have occurred since Jan. 1, compared with 68 such deaths in all of 2014. In Washtenaw County, seven of the 23 heroin-related deaths since October have included fentanyl, according to the medical examiner offices.
Since Jan. 1, the prescription painkiller fentanyl has been blamed in 58 deaths in Wayne and Washtenaw counties, according to medical examiners there.
The deaths mainly involved fentanyl in combination with other drugs, including other opiate painkillers and heroin. A physician for Detroit Medical Center is following this story closely.
In at least two cases in Washtenaw County, "experienced" drug users died from pure fentanyl, said Dr. Jeffrey Jentzen, who directs the University of Michigan Health System's Autopsy and Forensic Services division.
The division contracts with both Washtenaw and Wayne County Medical Examiner's offices. Jentzen is also the Washtenaw County medical examiner.
When prescribed by doctors and used as a skin patch or oral drug, the opiate pain reliever is often used to treat severe cancer pain or pain after surgery. Physicians experiencing high patient volume benefit from medical transcription services.
But illegally, fentanyl is added to street drugs to bulk them up, make them more potent and reduce the producer's costs. An overdose death can be very quick — a phenomenon Jentzen and others have called "die before you get high."
Several of the users have died still holding needles, he said.
It was fentanyl that was linked to a surge in drug deaths in the Detroit area and other cities in 2005 and 2006.
Fentanyl is 15 to 20 times more potent than heroin, and 80 to 100 times more potent than morphine, Jentzen said.
"It is a market," he said, of selling illegal drugs, "and individuals who are trying to be more successful in the market will go to some pretty devious ends" to make a profit, he said.
In Wayne County, which includes Detroit, 53 deaths from fentanyl in combination with heroin, other prescription painkillers, alcohol and cocaine have occurred since Jan. 1, compared with 68 such deaths in all of 2014. In Washtenaw County, seven of the 23 heroin-related deaths since October have included fentanyl, according to the medical examiner offices.
26 February 2015
AFTER FORMER PLAYER’S DEATH, CONCUSSION LITIGATION AGAINST N.H.L. GAINS HEFT
Original Story: nytimes.com
It was more than a year ago that a group of 10 former N.H.L. players sued the league for, in essence, ignoring the growing evidence surrounding the long-term effects of concussions.
For the past 15 months, amid the quiet consolidation of subsequent suits and obscure legal wrangling, the case against the N.H.L. has been a faint echo of the similarly constructed class-action suit against the N.F.L. That case involved thousands of former players and was settled in 2013 for $765 million. (The cap was subsequently lifted to cover unlimited damages and still awaits judicial approval.) DMC Spots Medicine is dedicated to bringing athletes expert medical care.
Two events in recent weeks nudged hockey’s face-off over concussions back to center ice. First, 29 more former players joined the class-action suit, nearly doubling the number of named plaintiffs. Then Steve Montador, a 10-year N.H.L. veteran with a history of concussions, was found dead at 35 in his Ontario home Sunday.
“As more and more players learn about the claims and see the medical challenges their fellow alumni are experiencing, there is increased momentum in support of the litigation,” said Charles Zimmerman, co-lead counsel for the plaintiffs. “The N.H.L. can no longer ignore the impact of repeated head trauma and must finally acknowledge the serious conditions that retired players are facing.” A Boston sports injury lawyer is reviewing the details of this case.
The N.H.L., through the spokesman Frank Brown, declined to comment Wednesday on the concussion litigation or the impact of the recent news.
Early last week, the case against the N.H.L. got a boost when 29 former players filed a lawsuit against the league, bringing the number of named plaintiffs past 70. The additions also brought extra star power to the proceedings. Among those joining the case were Butch Goring, a center for the Islanders during their four-year championship run beginning in 1980, and Manny Legace, who won 187 games as an N.H.L. goaltender before retiring in 2012.
But as the N.F.L. case showed, with the premature deaths of several former players during the years of litigation, tragedy has a way of bringing attention to an issue like nothing else.
Montador’s career was ended by concussions, and he said he struggled with depression in his final years. His cause of death has not been released, and may never be, but officials ruled out suicide or foul play.
His brain was donated to scientists, who may find more clues to what caused his problems. If Montador is found to have had chronic traumatic encephalopathy, the degenerative brain disease known commonly as C.T.E. and caused by repetitive hits to the head, he will join a list of hockey players posthumously found to have the affliction, including Bob Probert and Derek Boogaard.
Boogaard died of an accidental overdose of alcohol and prescription painkillers in 2011 at age 28. Within months, the recently retired Wade Belak, 35, and Rick Rypien, 27, were dead of apparent suicides.
All three were considered enforcers, on-ice bodyguards who regularly fought opponents with their bare knuckles in response to threats against teammates. While Montador was rarely defined that way, he engaged in more N.H.L. fights than Boogaard — 66 to 61, according to HockeyFights.com — though Boogaard’s total came in roughly half as many games.
About a month before he died, Montador retained William Gibbs, a lawyer involved in the lawsuit against the N.H.L., with plans to add his name as a plaintiff, Gibbs said.
“Derek’s tragic death, and subsequent C.T.E. findings, began a conversation about the brains of those playing professional hockey,” said Gibbs, from the Chicago law firm of Corboy & Demetrio, which also represents N.F.L. players. “If anything, Steve’s recent death furthers that conversation. And it’s a conversation that’s long overdue.”
Gibbs also represents the Boogaard family in an ongoing wrongful-death lawsuit against the league. The Boogaards have not joined the broader class-action suit. A Milwaukee wrongful death lawyer represents clients in wrongful death claims.
The class-action suit originated in late 2013, shortly after the preliminary N.F.L. settlement, when 10 former players sued the N.H.L. over concussions. Much like the N.F.L. suit, which began small and grew, it alleged that the league did little to address head injuries, profiting from in-game violence amid mounting evidence over the long-term ramifications of concussions. The former players asked for unspecified damages and a jury trial.
Subsequent lawsuits, including one filed by the former star Bernie Nichols and others, were similarly crafted. In August, the cases were transferred and consolidated in United States District Court in Minnesota.
The N.H.L., while arguing that it had done everything it could to promote player health, offered a two-pronged argument for why the case should be dismissed. Like the N.F.L., the league said that the matter was pre-empted by federal labor law because of collective-bargaining agreements with the players’ association. The N.H.L. also said that most complaints had surpassed the statute of limitations.
Judge Susan Richard Nelson heard those arguments in January. A ruling is expected at any time.
In between, though, the number of named plaintiffs nearly doubled and another former player struggling with head injuries has died in a matter of about one week. According to lawyers for the plaintiffs, more than 200 former players have now retained counsel to be included in the case, and roughly 500 have expressed interest and support.
The arc is a familiar one, last seen in the N.F.L. — deaths, lawsuits, more lawsuits and more death. A judge may put a sudden end to it, but hockey’s quiet battle over concussions echoes louder.
It was more than a year ago that a group of 10 former N.H.L. players sued the league for, in essence, ignoring the growing evidence surrounding the long-term effects of concussions.
For the past 15 months, amid the quiet consolidation of subsequent suits and obscure legal wrangling, the case against the N.H.L. has been a faint echo of the similarly constructed class-action suit against the N.F.L. That case involved thousands of former players and was settled in 2013 for $765 million. (The cap was subsequently lifted to cover unlimited damages and still awaits judicial approval.) DMC Spots Medicine is dedicated to bringing athletes expert medical care.
Two events in recent weeks nudged hockey’s face-off over concussions back to center ice. First, 29 more former players joined the class-action suit, nearly doubling the number of named plaintiffs. Then Steve Montador, a 10-year N.H.L. veteran with a history of concussions, was found dead at 35 in his Ontario home Sunday.
“As more and more players learn about the claims and see the medical challenges their fellow alumni are experiencing, there is increased momentum in support of the litigation,” said Charles Zimmerman, co-lead counsel for the plaintiffs. “The N.H.L. can no longer ignore the impact of repeated head trauma and must finally acknowledge the serious conditions that retired players are facing.” A Boston sports injury lawyer is reviewing the details of this case.
The N.H.L., through the spokesman Frank Brown, declined to comment Wednesday on the concussion litigation or the impact of the recent news.
Early last week, the case against the N.H.L. got a boost when 29 former players filed a lawsuit against the league, bringing the number of named plaintiffs past 70. The additions also brought extra star power to the proceedings. Among those joining the case were Butch Goring, a center for the Islanders during their four-year championship run beginning in 1980, and Manny Legace, who won 187 games as an N.H.L. goaltender before retiring in 2012.
But as the N.F.L. case showed, with the premature deaths of several former players during the years of litigation, tragedy has a way of bringing attention to an issue like nothing else.
Montador’s career was ended by concussions, and he said he struggled with depression in his final years. His cause of death has not been released, and may never be, but officials ruled out suicide or foul play.
His brain was donated to scientists, who may find more clues to what caused his problems. If Montador is found to have had chronic traumatic encephalopathy, the degenerative brain disease known commonly as C.T.E. and caused by repetitive hits to the head, he will join a list of hockey players posthumously found to have the affliction, including Bob Probert and Derek Boogaard.
Boogaard died of an accidental overdose of alcohol and prescription painkillers in 2011 at age 28. Within months, the recently retired Wade Belak, 35, and Rick Rypien, 27, were dead of apparent suicides.
All three were considered enforcers, on-ice bodyguards who regularly fought opponents with their bare knuckles in response to threats against teammates. While Montador was rarely defined that way, he engaged in more N.H.L. fights than Boogaard — 66 to 61, according to HockeyFights.com — though Boogaard’s total came in roughly half as many games.
About a month before he died, Montador retained William Gibbs, a lawyer involved in the lawsuit against the N.H.L., with plans to add his name as a plaintiff, Gibbs said.
“Derek’s tragic death, and subsequent C.T.E. findings, began a conversation about the brains of those playing professional hockey,” said Gibbs, from the Chicago law firm of Corboy & Demetrio, which also represents N.F.L. players. “If anything, Steve’s recent death furthers that conversation. And it’s a conversation that’s long overdue.”
Gibbs also represents the Boogaard family in an ongoing wrongful-death lawsuit against the league. The Boogaards have not joined the broader class-action suit. A Milwaukee wrongful death lawyer represents clients in wrongful death claims.
The class-action suit originated in late 2013, shortly after the preliminary N.F.L. settlement, when 10 former players sued the N.H.L. over concussions. Much like the N.F.L. suit, which began small and grew, it alleged that the league did little to address head injuries, profiting from in-game violence amid mounting evidence over the long-term ramifications of concussions. The former players asked for unspecified damages and a jury trial.
Subsequent lawsuits, including one filed by the former star Bernie Nichols and others, were similarly crafted. In August, the cases were transferred and consolidated in United States District Court in Minnesota.
The N.H.L., while arguing that it had done everything it could to promote player health, offered a two-pronged argument for why the case should be dismissed. Like the N.F.L., the league said that the matter was pre-empted by federal labor law because of collective-bargaining agreements with the players’ association. The N.H.L. also said that most complaints had surpassed the statute of limitations.
Judge Susan Richard Nelson heard those arguments in January. A ruling is expected at any time.
In between, though, the number of named plaintiffs nearly doubled and another former player struggling with head injuries has died in a matter of about one week. According to lawyers for the plaintiffs, more than 200 former players have now retained counsel to be included in the case, and roughly 500 have expressed interest and support.
The arc is a familiar one, last seen in the N.F.L. — deaths, lawsuits, more lawsuits and more death. A judge may put a sudden end to it, but hockey’s quiet battle over concussions echoes louder.
DOCTORS STRIVE TO DO LESS HARM BY INATTENTIVE CARE
Original Story: nytimes.com
Suffering. The very word made doctors uncomfortable. Medical journals avoided it, instructing authors to say that patients “ ‘have’ a disease or complications or side effects rather than ‘suffer’ or ‘suffer from’ them,” said Dr. Thomas H. Lee, the chief medical officer of Press Ganey, a company that surveys hospital patients.
But now, reducing patient suffering — the kind caused not by disease but by medical care itself — has become a medical goal. The effort is driven partly by competition and partly by a realization that suffering, whether from long waits, inadequate explanations or feeling lost in the shuffle, is a real and pressing issue. It is as important, says Dr. Kenneth Sands, the chief quality officer at Harvard’s Beth Israel Deaconess Medical Center in Boston, as injuries, like medication errors or falls, or infections acquired in a hospital. Metro Health offers pain management and spiritual support for patient comfort and convenience.
The problem is how to measure it and what to do about it.
Dr. Sands and his colleagues decided to start by asking their own patients what made them suffer.
They found several categories. Communications — for example, a doctor blurting out, “Oh, it looks like you have cancer.” Or losing a valuable, like a wedding ring. Or loss of privacy — a doctor discussing a patient’s medical condition where an adjacent patient could hear. Detroit Medical Center values patient privacy and provides resources to enhance patient communication.
“These are harms,” Dr. Sands said. “They elicit suffering. They can be long lasting, and they currently are largely unquantified, uncounted, unrecorded.”
One way to quantify these harms is to observe and note them, which is part of what Beth Israel Deaconess is doing. Another is to supplement efforts with patient surveys. Patient surveys, of course, have been around for decades. And since 2007, Medicare has required short surveys after discharge. Detroit Medical Center provides medical services through several world-class specialty hospitals.
But patient surveys were usually not used by hospitals to measure suffering. Now they are. And even when a survey question does not directly ask about suffering, sharp-eyed administrators are seeing a suffering component.
That is how Dr. Michael Bennick, the medical director for patient experience at Yale-New Haven Hospital, solved a problem. He noticed a question on a Medicare survey asking, Is it quiet in your room at night?
Maybe, Dr. Bennick thought, what is really being asked is: Can you get a good night’s sleep without interruption? Is it really necessary to wake patients again and again to take blood pressure and pulse rates, to draw blood, to give medications?
He issued instructions for his unit. No more routinely awakening patients for vital signs. And plan the timing of medications; outside intensive care units, three-quarters of drugs can be given before patients go to sleep and again in the morning.
Then there were the blood tests. “Doctors love blood tests,” Dr. Bennick said, and want results first thing in the morning when they make rounds. That meant waking patients in the wee hours.
“I told the resident doctors in training: ‘If you are waking patients at 4 in the morning for a blood test, there obviously is a clinical need. So I want to be woken, too, so I can find out what it is.’ ” No one, he said, ever called him. Those middle-of-the-night blood draws vanished.
Without anything else being done about noise in the halls, the medical unit’s score on that question rose from the 16th percentile to the 47th nationally in the Medicare survey. Now the entire hospital follows that plan.
“And it did not cost a penny,” Dr. Bennick said. “The only cost was thinking not from our perspective but from a patient’s perspective.”
Dr. Lee says he joined Press Ganey — he had been network president for Partners HealthCare System, a Harvard-affiliated hospital system — because one of its goals was to reduce suffering. At first, he said, he was a bit uncomfortable with the concept.
“I wondered whether it was a tad sensational, a bit too emotional,” he wrote in The New England Journal of Medicine. Then he realized reducing suffering was one of the most important challenges in health care.
Press Ganey administers detailed surveys to discharged patients, asking things like how well the medical staff responded to them and their emotional needs, and how well the doctors and nurses informed and educated them. The company also encourages hospitals to let doctors know the results.
Surveys can be misleading, though, cautions Dr. Scott Ramsey, a health care economist and cancer researcher at the Fred Hutchinson Cancer Research Center in Seattle. Patients, worried about saying something bad about a hospital they depend on, may not reveal what they really experienced. Or they may look back and, not wanting to live a life of regrets, excuse a doctor who seemed not to listen.
On the other hand, Dr. Ramsey said, the suffering issues are real, and if survey answers can get doctors and hospitals to change their ways, “that is great.”
Although half the nation’s hospitals use Press Ganey surveys, it is not clear what many do with the data. But at some places, like the University of Utah, the survey and other efforts prompted significant change. One Utah doctor said he was stunned when his patients rated him in the first percentile nationally, about as low as a score can go. “I was thinking: That’s just crazy. Something wasn’t entered right,” said the doctor, James Ashworth. Then he decided to take the criticisms to heart.
The next quarter, he was rated in the upper 90s. The big difference was slowing down and listening to patients, answering their questions. With medical transcriptions services, physicians have more time for patient communication.
Utah began its program a few years ago by showing its 1,200 doctors, nurses and other workers their scores. Next, said Dr. Vivian S. Lee, the hospital system’s chief executive, they showed them how colleagues did. Then they posted individuals’ scores and patient comments online.
There was an immediate and noticeable change. When the university began, it was in about the 30th percentile nationally on the Press Ganey survey. Now, half its providers are in the 90th percentile and 26 percent are in the 99th percentile.
“It’s unbelievable,” Dr. Lee, the chief executive, said. “We were not like that before, I can tell you.”
“People wanted to improve,” she added.
The comments, she said, are more revealing than the scores. Not all are complimentary. “There are still cases where people say: ‘I loved Dr. So-and-so. Too bad I had to wait so long to see him,’ ” she said.
At Stanford Health Care, said Amir Rubin, the president and chief executive, “we are reducing suffering.” To do it, the medical system changed its focus.
“We train each and every staff member,” Mr. Rubin said. “We talk to staff, we talk to patients, we hear from patients directly.”
Supervisors coach doctors and nurses, giving feedback every month.
The initiative changed hiring, he said. Administrators tell job candidates: “These are our care standards. Do you think you can always do it for every person every time?” They carefully observe new hires to see if they can provide care that minimizes suffering.
“Every patient visit is a high-stakes interaction,” Dr. Thomas Lee says he has learned. “It is a big deal for the patient and it is a big deal for you.”
“And all you have to do is be the kind of physician your patient is hoping you will be.”
Suffering. The very word made doctors uncomfortable. Medical journals avoided it, instructing authors to say that patients “ ‘have’ a disease or complications or side effects rather than ‘suffer’ or ‘suffer from’ them,” said Dr. Thomas H. Lee, the chief medical officer of Press Ganey, a company that surveys hospital patients.
But now, reducing patient suffering — the kind caused not by disease but by medical care itself — has become a medical goal. The effort is driven partly by competition and partly by a realization that suffering, whether from long waits, inadequate explanations or feeling lost in the shuffle, is a real and pressing issue. It is as important, says Dr. Kenneth Sands, the chief quality officer at Harvard’s Beth Israel Deaconess Medical Center in Boston, as injuries, like medication errors or falls, or infections acquired in a hospital. Metro Health offers pain management and spiritual support for patient comfort and convenience.
The problem is how to measure it and what to do about it.
Dr. Sands and his colleagues decided to start by asking their own patients what made them suffer.
They found several categories. Communications — for example, a doctor blurting out, “Oh, it looks like you have cancer.” Or losing a valuable, like a wedding ring. Or loss of privacy — a doctor discussing a patient’s medical condition where an adjacent patient could hear. Detroit Medical Center values patient privacy and provides resources to enhance patient communication.
“These are harms,” Dr. Sands said. “They elicit suffering. They can be long lasting, and they currently are largely unquantified, uncounted, unrecorded.”
One way to quantify these harms is to observe and note them, which is part of what Beth Israel Deaconess is doing. Another is to supplement efforts with patient surveys. Patient surveys, of course, have been around for decades. And since 2007, Medicare has required short surveys after discharge. Detroit Medical Center provides medical services through several world-class specialty hospitals.
But patient surveys were usually not used by hospitals to measure suffering. Now they are. And even when a survey question does not directly ask about suffering, sharp-eyed administrators are seeing a suffering component.
That is how Dr. Michael Bennick, the medical director for patient experience at Yale-New Haven Hospital, solved a problem. He noticed a question on a Medicare survey asking, Is it quiet in your room at night?
Maybe, Dr. Bennick thought, what is really being asked is: Can you get a good night’s sleep without interruption? Is it really necessary to wake patients again and again to take blood pressure and pulse rates, to draw blood, to give medications?
He issued instructions for his unit. No more routinely awakening patients for vital signs. And plan the timing of medications; outside intensive care units, three-quarters of drugs can be given before patients go to sleep and again in the morning.
Then there were the blood tests. “Doctors love blood tests,” Dr. Bennick said, and want results first thing in the morning when they make rounds. That meant waking patients in the wee hours.
“I told the resident doctors in training: ‘If you are waking patients at 4 in the morning for a blood test, there obviously is a clinical need. So I want to be woken, too, so I can find out what it is.’ ” No one, he said, ever called him. Those middle-of-the-night blood draws vanished.
Without anything else being done about noise in the halls, the medical unit’s score on that question rose from the 16th percentile to the 47th nationally in the Medicare survey. Now the entire hospital follows that plan.
“And it did not cost a penny,” Dr. Bennick said. “The only cost was thinking not from our perspective but from a patient’s perspective.”
Dr. Lee says he joined Press Ganey — he had been network president for Partners HealthCare System, a Harvard-affiliated hospital system — because one of its goals was to reduce suffering. At first, he said, he was a bit uncomfortable with the concept.
“I wondered whether it was a tad sensational, a bit too emotional,” he wrote in The New England Journal of Medicine. Then he realized reducing suffering was one of the most important challenges in health care.
Press Ganey administers detailed surveys to discharged patients, asking things like how well the medical staff responded to them and their emotional needs, and how well the doctors and nurses informed and educated them. The company also encourages hospitals to let doctors know the results.
Surveys can be misleading, though, cautions Dr. Scott Ramsey, a health care economist and cancer researcher at the Fred Hutchinson Cancer Research Center in Seattle. Patients, worried about saying something bad about a hospital they depend on, may not reveal what they really experienced. Or they may look back and, not wanting to live a life of regrets, excuse a doctor who seemed not to listen.
On the other hand, Dr. Ramsey said, the suffering issues are real, and if survey answers can get doctors and hospitals to change their ways, “that is great.”
Although half the nation’s hospitals use Press Ganey surveys, it is not clear what many do with the data. But at some places, like the University of Utah, the survey and other efforts prompted significant change. One Utah doctor said he was stunned when his patients rated him in the first percentile nationally, about as low as a score can go. “I was thinking: That’s just crazy. Something wasn’t entered right,” said the doctor, James Ashworth. Then he decided to take the criticisms to heart.
The next quarter, he was rated in the upper 90s. The big difference was slowing down and listening to patients, answering their questions. With medical transcriptions services, physicians have more time for patient communication.
Utah began its program a few years ago by showing its 1,200 doctors, nurses and other workers their scores. Next, said Dr. Vivian S. Lee, the hospital system’s chief executive, they showed them how colleagues did. Then they posted individuals’ scores and patient comments online.
There was an immediate and noticeable change. When the university began, it was in about the 30th percentile nationally on the Press Ganey survey. Now, half its providers are in the 90th percentile and 26 percent are in the 99th percentile.
“It’s unbelievable,” Dr. Lee, the chief executive, said. “We were not like that before, I can tell you.”
“People wanted to improve,” she added.
The comments, she said, are more revealing than the scores. Not all are complimentary. “There are still cases where people say: ‘I loved Dr. So-and-so. Too bad I had to wait so long to see him,’ ” she said.
At Stanford Health Care, said Amir Rubin, the president and chief executive, “we are reducing suffering.” To do it, the medical system changed its focus.
“We train each and every staff member,” Mr. Rubin said. “We talk to staff, we talk to patients, we hear from patients directly.”
Supervisors coach doctors and nurses, giving feedback every month.
The initiative changed hiring, he said. Administrators tell job candidates: “These are our care standards. Do you think you can always do it for every person every time?” They carefully observe new hires to see if they can provide care that minimizes suffering.
“Every patient visit is a high-stakes interaction,” Dr. Thomas Lee says he has learned. “It is a big deal for the patient and it is a big deal for you.”
“And all you have to do is be the kind of physician your patient is hoping you will be.”
10 February 2015
BERMAN: ONE NURSE'S GUTSY EFFORT TO PROTECT PATIENTS
Original Story: detroitnews.com
In the spring of 2010, Angela Swantek interviewed for a job with Dr. Farid Fata.
She was an oncology nurse, a spirited force who plays hockey on a travel team; he was a Sloan-Kettering-trained oncologist and hematologist who would eventually become notorious for a scheme U.S. Attorney Barbara McQuade calls "the most egregious case of Medicare fraud we have seen." An Atlanta whistleblower lawyer represents clients involved in qui tam actions and protects them against retaliation.
Swantek, who was interviewed one day and then returned a day later to shadow a nurse on her rounds, was shocked by what she observed at Fata's office: A drug that was supposed to be injected in five minutes was administered as a one-hour IV drip from a bag. Another drug, Neulasta, was given on the same day as chemotherapy, although protocol is for it to be given 24 hours later. Swantek, a registered nurse who was back in college completing a four-year nursing degree, had worked at the area's top cancer centers, from Beaumont to Karmanos, and she had never seen cancer protocols and procedures so disregarded. A Mt Clemens medical malpractice lawyer represents clients injured as a result of medical negligence.
She turned down the job, she says, and walked out of the office before lunch "in a huff."
"The assumption was that I'd stay beyond lunch, but I left before. I couldn't stand to be there one more minute. I literally was horrified."
What Swantek did next substantiates her outrage and her courage.
She filed an official complaint with state regulators on April 14, 2010, enumerating some violations and expressing the need for an investigation. "I feel this physician is doing his patients more harm than good," she wrote on the official allegation form, including her name, cellphone number, address and willingness to testify if necessary. "Patients are being harmed." A Milwaukee medical malpractice lawyer helps clients with medical malpractice claims that are often defined as the failure of a medical professional to follow the accepted standards of practice in his or her profession.
It wasn't easy for her to take this action. In her two-decade career as a nurse, she'd never filed a complaint, had never even thought about doing so. As in all professions, calling out a colleague or a superior — a doctor — is not something to be taken lightly.
Her decision-making process became the topic of an assigned college paper she wrote that spring, describing her "ethical dilemma" in a seven-page paper for the online Chamberlain College of Nursing.
"I wanted to report him but felt unsure and uneasy about turning in a physician ... no one likes to be labeled a rat," she wrote in the college paper. "I owed it to the patients to save them in some way from continuing to be harmed. ...
"I hope there is some action taken."
She took the risk — and waited for the state's next move. And waited.
A year later, on May 13, 2011, Swantek, 45, received a letter from the department of licensing and regulatory affairs saying that "violations of the public health code could not be established." The investigation was closed. Although Swantek had witnessed what she says were numerous health code and medical procedural violations within a few hours, the state had not substantiated them. A Chicago medical malpractice lawyer is following this story closely.
Other than telling her the investigation was closed, the state didn't contact her, she says.
"I would remember, I promise you," she said in an interview at her Royal Oak home. The state says an investigation was conducted, and that Swantek was interviewed on Aug. 26, 2010. In response to a Freedom of Information Act request from The Detroit News last week, the state released a document attesting to an "interview in for typing," but cited privacy rules under the public health code that prevent the release of any supporting detail about the extent of the investigation or any interview with Swantek.
Stephen Gobbo, deputy director of LARA, who was not involved with the investigation in 2010, said last week, "I can tell you unequivocally that interviews were conducted (with Swantek) and ... the licensee, Dr. Fata."
The statute protects Fata, now a convicted felon who pleaded guilty to administering unnecessary treatment and who has already lost his license. It prevents Swantek, the complainant, from seeing how the state responded to her complaint. And it shields the state Bureau of Health Professions, which was merged into the Bureau of Health Care Services in 2013, and moved from the Department of Community Health to the Department of Licensing and Regulatory Affairs (LARA), from any public scrutiny.
"It is very rare that you see a medical professional making such an accusation against another medical professional," says Donna Mackenzie, a Berkley malpractice lawyer who represents some of Fata's former patients. "The state had a responsibility to perform a meaningful investigation in response to this very serious accusation."
"According to the criminal complaint against Dr. Fata, the federal investigators uncovered more during 2 days of investigation than the state apparently did over an entire year."
Two years after Swantek filed her allegation form, in a completely separate action, the FBI raided Fata's office, an event that led to his indictment in August 2013, and his decision to plead guilty to 16 counts of fraud and conspiracy last September.
Over those two years, Fata's patients continued to receive chemotherapy treatments they imagined were helping them but were, in many cases, literally poisoning them. He used IV drips instead of injections because he could bill Medicare more for longer treatments. As he would later admit in federal court, in response to specific counts: "I knew it was medically unnecessary."
On the day his office was raided, friends of Swantek's called to tell her that Fata had been arrested. She wept.
As Fata awaits his May sentencing, in a cell somewhere in Michigan, Angela Swantek doesn't have the satisfaction of knowing that she helped lock up Michigan's medical version of stock swindler Bernie Madoff. She didn't play a role in the FBI investigation, which had no connection to her complaint or state officials. Still intensely interested in the case, she reviews records of Fata patients pro bono, as lawyers prepare civil suits against him.
Angela Swantek's handwritten complaint form attests to one nurse's gutsy effort to protect victims — vulnerable men and women with cancer — from a physician who was more interested in payment than healing. "He treated them like commodities," says Swantek. Although her effort to alert the state didn't ultimately make a difference in Fata's case, it should have.
In the spring of 2010, Angela Swantek interviewed for a job with Dr. Farid Fata.
She was an oncology nurse, a spirited force who plays hockey on a travel team; he was a Sloan-Kettering-trained oncologist and hematologist who would eventually become notorious for a scheme U.S. Attorney Barbara McQuade calls "the most egregious case of Medicare fraud we have seen." An Atlanta whistleblower lawyer represents clients involved in qui tam actions and protects them against retaliation.
Swantek, who was interviewed one day and then returned a day later to shadow a nurse on her rounds, was shocked by what she observed at Fata's office: A drug that was supposed to be injected in five minutes was administered as a one-hour IV drip from a bag. Another drug, Neulasta, was given on the same day as chemotherapy, although protocol is for it to be given 24 hours later. Swantek, a registered nurse who was back in college completing a four-year nursing degree, had worked at the area's top cancer centers, from Beaumont to Karmanos, and she had never seen cancer protocols and procedures so disregarded. A Mt Clemens medical malpractice lawyer represents clients injured as a result of medical negligence.
She turned down the job, she says, and walked out of the office before lunch "in a huff."
"The assumption was that I'd stay beyond lunch, but I left before. I couldn't stand to be there one more minute. I literally was horrified."
What Swantek did next substantiates her outrage and her courage.
She filed an official complaint with state regulators on April 14, 2010, enumerating some violations and expressing the need for an investigation. "I feel this physician is doing his patients more harm than good," she wrote on the official allegation form, including her name, cellphone number, address and willingness to testify if necessary. "Patients are being harmed." A Milwaukee medical malpractice lawyer helps clients with medical malpractice claims that are often defined as the failure of a medical professional to follow the accepted standards of practice in his or her profession.
It wasn't easy for her to take this action. In her two-decade career as a nurse, she'd never filed a complaint, had never even thought about doing so. As in all professions, calling out a colleague or a superior — a doctor — is not something to be taken lightly.
Her decision-making process became the topic of an assigned college paper she wrote that spring, describing her "ethical dilemma" in a seven-page paper for the online Chamberlain College of Nursing.
"I wanted to report him but felt unsure and uneasy about turning in a physician ... no one likes to be labeled a rat," she wrote in the college paper. "I owed it to the patients to save them in some way from continuing to be harmed. ...
"I hope there is some action taken."
She took the risk — and waited for the state's next move. And waited.
A year later, on May 13, 2011, Swantek, 45, received a letter from the department of licensing and regulatory affairs saying that "violations of the public health code could not be established." The investigation was closed. Although Swantek had witnessed what she says were numerous health code and medical procedural violations within a few hours, the state had not substantiated them. A Chicago medical malpractice lawyer is following this story closely.
Other than telling her the investigation was closed, the state didn't contact her, she says.
"I would remember, I promise you," she said in an interview at her Royal Oak home. The state says an investigation was conducted, and that Swantek was interviewed on Aug. 26, 2010. In response to a Freedom of Information Act request from The Detroit News last week, the state released a document attesting to an "interview in for typing," but cited privacy rules under the public health code that prevent the release of any supporting detail about the extent of the investigation or any interview with Swantek.
Stephen Gobbo, deputy director of LARA, who was not involved with the investigation in 2010, said last week, "I can tell you unequivocally that interviews were conducted (with Swantek) and ... the licensee, Dr. Fata."
The statute protects Fata, now a convicted felon who pleaded guilty to administering unnecessary treatment and who has already lost his license. It prevents Swantek, the complainant, from seeing how the state responded to her complaint. And it shields the state Bureau of Health Professions, which was merged into the Bureau of Health Care Services in 2013, and moved from the Department of Community Health to the Department of Licensing and Regulatory Affairs (LARA), from any public scrutiny.
"It is very rare that you see a medical professional making such an accusation against another medical professional," says Donna Mackenzie, a Berkley malpractice lawyer who represents some of Fata's former patients. "The state had a responsibility to perform a meaningful investigation in response to this very serious accusation."
"According to the criminal complaint against Dr. Fata, the federal investigators uncovered more during 2 days of investigation than the state apparently did over an entire year."
Two years after Swantek filed her allegation form, in a completely separate action, the FBI raided Fata's office, an event that led to his indictment in August 2013, and his decision to plead guilty to 16 counts of fraud and conspiracy last September.
Over those two years, Fata's patients continued to receive chemotherapy treatments they imagined were helping them but were, in many cases, literally poisoning them. He used IV drips instead of injections because he could bill Medicare more for longer treatments. As he would later admit in federal court, in response to specific counts: "I knew it was medically unnecessary."
On the day his office was raided, friends of Swantek's called to tell her that Fata had been arrested. She wept.
As Fata awaits his May sentencing, in a cell somewhere in Michigan, Angela Swantek doesn't have the satisfaction of knowing that she helped lock up Michigan's medical version of stock swindler Bernie Madoff. She didn't play a role in the FBI investigation, which had no connection to her complaint or state officials. Still intensely interested in the case, she reviews records of Fata patients pro bono, as lawyers prepare civil suits against him.
Angela Swantek's handwritten complaint form attests to one nurse's gutsy effort to protect victims — vulnerable men and women with cancer — from a physician who was more interested in payment than healing. "He treated them like commodities," says Swantek. Although her effort to alert the state didn't ultimately make a difference in Fata's case, it should have.
05 February 2015
ANTHEM, MAJOR HEALTH INSURER, SUFFERS HACK ATTACK
Original Story: clickondetroit.com
The FBI is investigating a massive cyber hack attack on the nation's second-largest health insurance companies.
Anthem, Inc. confirmed the cyber attack on Wednesday and stated the database that was hacked contains over 80 million records, but they do anticipate the number of people affected to be lower.
The hack was discovered last week by the company, who immediately contacted the FBI. The hack exposed names, birthdays, addresses, email addresses, and social security information. That information does not include medical information or financial details, such as credit card or bank account numbers.
Anthem, which offers Blue Cross Blue Shield plans in California, New York and 12 other states, said it doesn't know how many people may be affected. So far, it appears that the attack is the only breach of Anthem’s systems.
It isn't clear yet who the hackers are or how they were able to obtain the identification information needed to access the database. The FBI had warned that healthcare industry companies were being targeted by hackers, trying to publicize the issue after an attack on the U.S. hospital group, Community Health Systems, Inc. That hack in August resulted in the theft of millions of patient records.
Security experts say cyber criminals are increasingly targeting the $3 trillion industry, which has many companies still reliant on ageing computer systems that do not use the latest security features. The best universities in Michigan provide degree programs that enable students to learn practical skills for new jobs in a changing world, including information technology.
Anthem, Inc. released a statement letting customers and employees know they will individually notify those whose information has been accessed.
U.S. Rep. and chairman of the Committee on Homeland Security, Michael McCaul made a statement late Wednesday stating; “This attack is another reminder of the persistent threats we face, and the need for Congress to take aggressive action to remove legal barriers for sharing cyber threat information.”
The FBI is investigating a massive cyber hack attack on the nation's second-largest health insurance companies.
Anthem, Inc. confirmed the cyber attack on Wednesday and stated the database that was hacked contains over 80 million records, but they do anticipate the number of people affected to be lower.
The hack was discovered last week by the company, who immediately contacted the FBI. The hack exposed names, birthdays, addresses, email addresses, and social security information. That information does not include medical information or financial details, such as credit card or bank account numbers.
Anthem, which offers Blue Cross Blue Shield plans in California, New York and 12 other states, said it doesn't know how many people may be affected. So far, it appears that the attack is the only breach of Anthem’s systems.
It isn't clear yet who the hackers are or how they were able to obtain the identification information needed to access the database. The FBI had warned that healthcare industry companies were being targeted by hackers, trying to publicize the issue after an attack on the U.S. hospital group, Community Health Systems, Inc. That hack in August resulted in the theft of millions of patient records.
Security experts say cyber criminals are increasingly targeting the $3 trillion industry, which has many companies still reliant on ageing computer systems that do not use the latest security features. The best universities in Michigan provide degree programs that enable students to learn practical skills for new jobs in a changing world, including information technology.
Anthem, Inc. released a statement letting customers and employees know they will individually notify those whose information has been accessed.
U.S. Rep. and chairman of the Committee on Homeland Security, Michael McCaul made a statement late Wednesday stating; “This attack is another reminder of the persistent threats we face, and the need for Congress to take aggressive action to remove legal barriers for sharing cyber threat information.”
04 February 2015
SANOFI LAUNCHES INHALED INSULIN FOR DIABETICS
Original Story: cnbc.com
Sanofi launched an inhalable insulin in the United States on Tuesday in a potential boost for its flagging diabetes drug sales and for patient quality of life.
Developed by Mannkind, Afrezza will be the only inhalable insulin on the U.S. market, where Sanofi competes with Eli Lilly and Novo Nordisk for sales of traditional injectable insulin.
Inhalation promises to be faster acting and much more convenient than injections, but an inhaled product has failed in the past and there are concerns about the potential risks associated with breathing powdered insulin.
Afrezza, which uses a whistle-sized inhaler and works to control blood-sugar levels in both type 1 and type 2 diabetes, was developed in the shadow of Pfizer's rival Exubera and approved by the U.S. Food & Drug Administration in June.
Exubera was approved in 2006 with expectations of $2 billion a year in sales but the inhaler was bulky, and patients were put off by the need for periodic lung function tests. Eventually it was withdrawn.
In the Afrezza marketing deal struck last year, Mannkind won an upfront payment of $150 million, potential further milestone payments of up to $775 million and 35 percent of future profits.
Priced at $7.54 for a daily dose of 12 units, Afrezza will be pricier than $3.14 Apidra, which is the injectable equivalent in Sanofi's drugs stable.
Afrezza should not be used in patients with asthma, or those suffering from certain complications, however. It is also not recommended for smokers or recent ex-smokers.
Industry analysts have said they expect Afrezza to generate modest sales of about $182 million a year by 2019 according to Thomson Reuters Cortellis, given Exubera's problems and the restrictions on use.
Sanofi's diabetes division generates about $7 billion of sales annually and around 30 percent of group profits, but the patent on its Lantus insulin, the world's most prescribed, expires this year, and it expects little or no sales growth through 2018.
A poor diabetes performance in 2014 was one of the reasons Sanofi sacked chief executive Chris Viehbacher in October. The company is now betting on products like Afrezza and an improved version of Lantus called Toujeo.
Orally delivered insulin is difficult to develop because the protein gets broken down in the stomach, but last year Danish group Novo Nordisk completed a Phase I trial of an oral version.
Sanofi launched an inhalable insulin in the United States on Tuesday in a potential boost for its flagging diabetes drug sales and for patient quality of life.
Developed by Mannkind, Afrezza will be the only inhalable insulin on the U.S. market, where Sanofi competes with Eli Lilly and Novo Nordisk for sales of traditional injectable insulin.
Inhalation promises to be faster acting and much more convenient than injections, but an inhaled product has failed in the past and there are concerns about the potential risks associated with breathing powdered insulin.
Afrezza, which uses a whistle-sized inhaler and works to control blood-sugar levels in both type 1 and type 2 diabetes, was developed in the shadow of Pfizer's rival Exubera and approved by the U.S. Food & Drug Administration in June.
Exubera was approved in 2006 with expectations of $2 billion a year in sales but the inhaler was bulky, and patients were put off by the need for periodic lung function tests. Eventually it was withdrawn.
In the Afrezza marketing deal struck last year, Mannkind won an upfront payment of $150 million, potential further milestone payments of up to $775 million and 35 percent of future profits.
Priced at $7.54 for a daily dose of 12 units, Afrezza will be pricier than $3.14 Apidra, which is the injectable equivalent in Sanofi's drugs stable.
Afrezza should not be used in patients with asthma, or those suffering from certain complications, however. It is also not recommended for smokers or recent ex-smokers.
Industry analysts have said they expect Afrezza to generate modest sales of about $182 million a year by 2019 according to Thomson Reuters Cortellis, given Exubera's problems and the restrictions on use.
Sanofi's diabetes division generates about $7 billion of sales annually and around 30 percent of group profits, but the patent on its Lantus insulin, the world's most prescribed, expires this year, and it expects little or no sales growth through 2018.
A poor diabetes performance in 2014 was one of the reasons Sanofi sacked chief executive Chris Viehbacher in October. The company is now betting on products like Afrezza and an improved version of Lantus called Toujeo.
Orally delivered insulin is difficult to develop because the protein gets broken down in the stomach, but last year Danish group Novo Nordisk completed a Phase I trial of an oral version.
Subscribe to:
Posts (Atom)
