Original Story: nytimes.com
The health insurer Anthem said on Friday that it had agreed to acquire its rival Cigna for $48.3 billion in a deal that would further concentrate the United States market to just a few major players.
The combined company would have estimated revenue of about $115 billion and serve more than 53 million people with medical coverage. An Atlanta healthcare litigation attorney is following this story closely.
A flurry of deals are reshaping the industry. Earlier this month Aetna agreed to acquire Humana, the smallest of the big five insurers, for $37 billion in cash and stock. If both transactions are completed, the number of major health insurers in the United States will shrink to three.
Health insurers are seeking to consolidate to gain greater scale to reduce costs and capitalize on growing opportunities in the government and individual markets. A major force has been the Obama administration’s health care overhaul, which has bolstered revenues. But greater transparency in pricing and less generous funding of government plans have also put profit margins under pressure.
Alex Cullen, an analyst with Forrester Research, said that the challenge for all health insurers was moving from “a plan and claim-centric model to a customer-centric model.” Making that transition while completing a merger will be difficult, he said. An Atlanta healthcare litigation lawyer is reviewing the details of this case.
“I would expect a lot of angst within Anthem management on how to execute on a customer-centric strategy,” Mr. Cullen said.
Anthem said on Friday that it expected to achieve nearly $2 billion in annual cost savings as a result of the merger. Anthem said there would be one-time charges of $600 million over a two-year period associated with the merger.
“We believe that this transaction will allow us to enhance our competitive position and be better positioned to apply the insights and access of a broad network and dedicated local presence to the health care challenges of the increasingly diverse markets, membership, and communities we serve,” Joseph R. Swedish, the Anthem chief executive, said in a news release.
Mr. Swedish will oversee the combined insurer.
Anthem, based in Indianapolis, operates Blue Cross plans in 14 states and has a strong presence in offering Medicaid plans. Cigna, based in Bloomfield, Conn., is best known for offering plans through employers and selling other kinds of insurance like dental and disability. A Birmingham healthcare lawyer represents clients in business operations and representative matters.
Unlike Cigna, Anthem has been a major presence on the public insurance marketplaces created by the federal health care law.
The recent appetite for deals among insurers was recently whetted by the Supreme Court’s upholding of the portion of the Affordable Care Act that subsidizes consumers who buy policies through the government’s online marketplace.
Under the terms of the deal, Anthem said it would pay $103.40 a share in cash and 0.5152 share in Anthem stock, or $188 a share. That represents a 38.4 percent premium to Cigna’s closing price on May 28, before news of Anthem’s interest emerged. Based on Cigna’s most recent disclosure of shares outstanding, the deal would value its equity at $48.3 million. Including the assumption of debt, Anthem said the deal would value Cigna at $54.2 billion.
After the deal is completed, Anthem shareholders will own 67 percent of the combined company, while the remaining 33 percent will be owned by Cigna shareholders.
David M. Cordani, the Cigna president and chief executive, will serve as president and chief operating officer of the combined company. The Anthem board of directors will also be expanded to 14 members and will include Mr. Cordani and four independent directors from Cigna.
The transaction is subject to shareholder and regulatory approval, and it is expected to close in the second half of 2016. A Pittsburgh healthcare lawyer represents physicians, hospitals, health systems, long-term facilities and other health care providers in a broad range of health care matters.
The deal has long been foretold. Anthem went public with its offer last month, saying that it had been in talks with Cigna over a possible combination since August.
It is possible that regulators in the United States could block some mergers: Antitrust officials at the Justice Department and the Federal Trade Commission have shown an increasing willingness to do so if they believe the alliances could hurt consumers.
Analysts have said that antitrust regulators would probably allow only some deals to go forward, and that they could stop others if they decided that too much power was being concentrated in too few hands.
The question remains what UnitedHealth Group, the largest health insurer in the United States, will now do.
UBS and Credit Suisse and the law firm White & Case advised Anthem, while Morgan Stanley and the law firm Cravath, Swaine & Moore advised Cigna.
27 July 2015
24 July 2015
COSTLY TO TREAT, HEPATITIS C GAINS QUIETLY IN U.S.
Original Story: nytimes.com
EDGEWOOD, Ky. — Zach Wayman says he first contracted hepatitis C several years ago by sharing needles with other heroin addicts. He went into rehab and was successfully treated for the virus. But he relapsed into addiction and reinfected himself, testing positive for hepatitis C again this spring.
“Pretty much everybody in my rehab has it,” said Mr. Wayman, 25, who started abusing pain pills at 18 and switched to heroin a few years later.
Mr. Wayman is part of an epidemic affecting young intravenous drug users across the country, particularly in Appalachia, where opiate abuse exploded in the late 1990s and never subsided. And that has health officials concerned, not just because the hepatitis C virus can lead to liver failure, cancer and sometimes death, but also because its spread can foretell another deadly disease: H.I.V., which can also be transmitted by shared needles.
Earlier this year, in Scott County, just 90 miles from here in rural southern Indiana, more than 160 people tested positive for H.I.V., and 86 percent of those people were also found to have hepatitis C. Most of those infected had shared needles to inject a prescription opiate called Opana.
In May, the Centers for Disease Control and Prevention reported a sharp increase in reported cases of hepatitis C among young adults in Kentucky, Tennessee, Virginia and West Virginia. While rates of acute hepatitis C, which is very costly to treat, have risen around the country, Kentucky’s rate was more than seven times the national average.
And the numbers most likely do not even begin to capture the problem, according to the C.D.C., which estimates that only one in every 10 cases is reported, partly because people with hepatitis often have no symptoms.
“It’s definitely the tip of a much larger iceberg,” said John Ward, director of the division of viral hepatitis at the C.D.C.
The agency estimates that more than three million people nationally have hepatitis C, which caused more than 15,000 deaths in 2013. Left untreated, the virus inflames and may eventually scar the liver, making it less effective at filtering toxins and other crucial functions. It sometimes leads to liver failure and liver cancer, and is the most common reason for liver transplants.
Reminded of the H.I.V. dangers that an hepatitis C epidemic can portend, counties and cities across this region are scrambling to contain the spread of both viruses, including by establishing programs where addicts can exchange dirty needles for clean ones.
Here in northern Kentucky, St. Elizabeth Healthcare, a regional hospital system, confirms up to 10 new cases of hepatitis C daily, said Deborah Henson, an infection control practitioner. Each positive test result starts a chain of events now all too familiar: St. Elizabeth reports it to the Northern Kentucky Health Department, which tracks down infected individuals to investigate how they contracted the virus and to try to keep them from spreading it. Some continue sharing needles and abusing drugs, while others make their way to hepatitis specialists whose caseloads are exploding.
They often learn that their insurance, if they have any, will not cover the treatment — highly effective new drugs cost at least $84,000 for a typical 12-week course. The cost of the new hepatitis drugs is so high that state Medicaid programs and many private insurers say that even treating a fraction of the infected population is breaking the bank.
Last year, Kentucky spent more than $50 million, about 7 percent of its total Medicaid budget, providing two of the new hepatitis C drugs, Sovaldi and Harvoni, to just 861 people, said Dr. John Langefeld, chief medical officer at the state’s Department for Medicaid Services. Sovaldi has a list price of $84,000 for a typical 12-week course of treatment; Harvoni, made by the same company, Gilead Sciences, has a list price closer to $100,000. Gilead offers discounts to Medicaid programs, but “it doesn’t do much to offset the significant cost factor,” Dr. Langefeld said.
In all, about 16,000 Kentucky Medicaid beneficiaries had a diagnosis of hepatitis C last year, up from 8,000 in 2013. That partly reflects the expansion of Medicaid under the Affordable Care Act to include more low-income adults, Dr. Langefeld said. But the state’s opiate problem, and increased testing of people who have injected drugs, are also factors, he and other health officials said. Kentucky will soon start providing hepatitis C tests at all its county health departments, just as it does for H.I.V.
Medicaid beneficiaries here are covered by private managed-care plans, each with its own rules for who can get the new hepatitis drugs. But patients generally need proof of Stage 3 or 4 fibrosis, or scarring of the liver, and cannot have used illicit drugs for at least six months, Dr. Langefeld said.
Karen Ruschman, a nurse practitioner at a private gastroenterology practice here, said many young adults with hepatitis C have not been able to quit heroin because treatment programs, especially those using Suboxone, a medication that suppresses opiate cravings, are expensive and hard to get into. Addicts typically “can buy heroin cheaper than they can get into a Suboxone clinic,” Ms. Ruschman said.
The vast majority of those infected with hepatitis C are baby boomers, according to the C.D.C. Most were infected decades ago, and many got it from blood transfusions that they received before 1992 when donated blood was not screened for the virus.
But most new cases are among young people, data has shown, and that raises a potential treatment problem: Those younger people tend not to qualify for the expensive new drugs, health care providers said, because the disease can take decades to progress to the point of severe liver damage.
Kentucky is not alone in rationing the drugs. A new study by researchers at Harvard found that about three-quarters of state Medicaid programs allow sofosbuvir, the main ingredient in Sovaldi, to be used only when hepatitis C has caused Stage 3 or 4 fibrosis. The study pointed out that such restrictions are at odds with the position of medical groups like the Infectious Diseases Society of America, which recommend the new treatments for all diagnosed cases.
In addition, the study’s authors wrote, “Current restrictions may violate federal Medicaid law, which requires states to cover drugs consistent with their F.D.A. labels.”
Many with hepatitis C are still in the throes of addiction, or are not far along enough in their recovery to focus on anything else. Others remain unaware of the new treatment options. Jerry Searp, who stopped injecting heroin in November 2011 and tested positive for hepatitis C a few months later, said he knew only about treatment with interferon and ribavirin, older drugs that often caused depression, fatigue, nausea and other debilitating side effects.
“They said my levels were real low,” he said, recalling a doctor’s appointment last year, “so I just keep praying about it.”
Mr. Searp, 34, of Crescent Spring, believes he knows exactly when he contracted the virus: while shooting up with a friend in a house frequented by addicts.
“I asked to use his needle and he said, ‘Hey, I’ve got hep B and C,’ ” Mr. Searp said. “And at the time it didn’t really matter to me. The desire to get high was just so great.”
Mr. Wayman, a warehouse worker, said his doctor was trying to persuade his insurer to pay for one of the new drugs, which were not yet available the first time he sought treatment. He hopes to qualify for the new treatment before December, when he will turn 26 and no longer be covered by his parents’ health insurance.
“It’s in my past and I don’t want my past to haunt me,” he said. “I’m just waiting on that phone call.”
In Crestview Hills, outside Cincinnati, Dr. Thomas Schussler has 25 patients receiving treatment for hepatitis C and another 140 patients waiting for it, typically because their insurer has not yet approved it or because they are still using drugs. Dr. Schussler said private insurance is more likely to cover the cost, but only about 20 percent of his patients have it. The success rate with the new drugs is remarkable, he said, but he added, “The problem is we’re not getting anywhere. You could eradicate this if the drugs were ubiquitous and cheap.”
Lynne Saddler, who leads the Northern Kentucky Health Department, is pursuing another avenue for getting a handle on the epidemic: starting a needle exchange so that addicts in the region might stop infecting each other. This year, the Kentucky General Assembly passed a law aimed at combating the state’s growing heroin problem, with a provision that allows local jurisdictions to open exchanges.
Louisville became the first city in Kentucky to take advantage of the new law last month. Needle exchanges are also in the works in several counties in Indiana, Ohio and West Virginia. The Northern Kentucky District Board of Health voted last month to move forward with an exchange, but it still must win approval from any city or county in which the exchange has a location. Ms. Saddler is trying to build support for it, including among opponents who believe needle exchanges only encourage drug use.
“This really is our window of opportunity,” she said. “When you lay that out for people — look, we have a statutory responsibility to prevent the spread of diseases like this and here is a very effective tool — they start getting it.”
EDGEWOOD, Ky. — Zach Wayman says he first contracted hepatitis C several years ago by sharing needles with other heroin addicts. He went into rehab and was successfully treated for the virus. But he relapsed into addiction and reinfected himself, testing positive for hepatitis C again this spring.
“Pretty much everybody in my rehab has it,” said Mr. Wayman, 25, who started abusing pain pills at 18 and switched to heroin a few years later.
Mr. Wayman is part of an epidemic affecting young intravenous drug users across the country, particularly in Appalachia, where opiate abuse exploded in the late 1990s and never subsided. And that has health officials concerned, not just because the hepatitis C virus can lead to liver failure, cancer and sometimes death, but also because its spread can foretell another deadly disease: H.I.V., which can also be transmitted by shared needles.
Earlier this year, in Scott County, just 90 miles from here in rural southern Indiana, more than 160 people tested positive for H.I.V., and 86 percent of those people were also found to have hepatitis C. Most of those infected had shared needles to inject a prescription opiate called Opana.
In May, the Centers for Disease Control and Prevention reported a sharp increase in reported cases of hepatitis C among young adults in Kentucky, Tennessee, Virginia and West Virginia. While rates of acute hepatitis C, which is very costly to treat, have risen around the country, Kentucky’s rate was more than seven times the national average.
And the numbers most likely do not even begin to capture the problem, according to the C.D.C., which estimates that only one in every 10 cases is reported, partly because people with hepatitis often have no symptoms.
“It’s definitely the tip of a much larger iceberg,” said John Ward, director of the division of viral hepatitis at the C.D.C.
The agency estimates that more than three million people nationally have hepatitis C, which caused more than 15,000 deaths in 2013. Left untreated, the virus inflames and may eventually scar the liver, making it less effective at filtering toxins and other crucial functions. It sometimes leads to liver failure and liver cancer, and is the most common reason for liver transplants.
Reminded of the H.I.V. dangers that an hepatitis C epidemic can portend, counties and cities across this region are scrambling to contain the spread of both viruses, including by establishing programs where addicts can exchange dirty needles for clean ones.
Here in northern Kentucky, St. Elizabeth Healthcare, a regional hospital system, confirms up to 10 new cases of hepatitis C daily, said Deborah Henson, an infection control practitioner. Each positive test result starts a chain of events now all too familiar: St. Elizabeth reports it to the Northern Kentucky Health Department, which tracks down infected individuals to investigate how they contracted the virus and to try to keep them from spreading it. Some continue sharing needles and abusing drugs, while others make their way to hepatitis specialists whose caseloads are exploding.
They often learn that their insurance, if they have any, will not cover the treatment — highly effective new drugs cost at least $84,000 for a typical 12-week course. The cost of the new hepatitis drugs is so high that state Medicaid programs and many private insurers say that even treating a fraction of the infected population is breaking the bank.
Last year, Kentucky spent more than $50 million, about 7 percent of its total Medicaid budget, providing two of the new hepatitis C drugs, Sovaldi and Harvoni, to just 861 people, said Dr. John Langefeld, chief medical officer at the state’s Department for Medicaid Services. Sovaldi has a list price of $84,000 for a typical 12-week course of treatment; Harvoni, made by the same company, Gilead Sciences, has a list price closer to $100,000. Gilead offers discounts to Medicaid programs, but “it doesn’t do much to offset the significant cost factor,” Dr. Langefeld said.
In all, about 16,000 Kentucky Medicaid beneficiaries had a diagnosis of hepatitis C last year, up from 8,000 in 2013. That partly reflects the expansion of Medicaid under the Affordable Care Act to include more low-income adults, Dr. Langefeld said. But the state’s opiate problem, and increased testing of people who have injected drugs, are also factors, he and other health officials said. Kentucky will soon start providing hepatitis C tests at all its county health departments, just as it does for H.I.V.
Medicaid beneficiaries here are covered by private managed-care plans, each with its own rules for who can get the new hepatitis drugs. But patients generally need proof of Stage 3 or 4 fibrosis, or scarring of the liver, and cannot have used illicit drugs for at least six months, Dr. Langefeld said.
Karen Ruschman, a nurse practitioner at a private gastroenterology practice here, said many young adults with hepatitis C have not been able to quit heroin because treatment programs, especially those using Suboxone, a medication that suppresses opiate cravings, are expensive and hard to get into. Addicts typically “can buy heroin cheaper than they can get into a Suboxone clinic,” Ms. Ruschman said.
The vast majority of those infected with hepatitis C are baby boomers, according to the C.D.C. Most were infected decades ago, and many got it from blood transfusions that they received before 1992 when donated blood was not screened for the virus.
But most new cases are among young people, data has shown, and that raises a potential treatment problem: Those younger people tend not to qualify for the expensive new drugs, health care providers said, because the disease can take decades to progress to the point of severe liver damage.
Kentucky is not alone in rationing the drugs. A new study by researchers at Harvard found that about three-quarters of state Medicaid programs allow sofosbuvir, the main ingredient in Sovaldi, to be used only when hepatitis C has caused Stage 3 or 4 fibrosis. The study pointed out that such restrictions are at odds with the position of medical groups like the Infectious Diseases Society of America, which recommend the new treatments for all diagnosed cases.
In addition, the study’s authors wrote, “Current restrictions may violate federal Medicaid law, which requires states to cover drugs consistent with their F.D.A. labels.”
Many with hepatitis C are still in the throes of addiction, or are not far along enough in their recovery to focus on anything else. Others remain unaware of the new treatment options. Jerry Searp, who stopped injecting heroin in November 2011 and tested positive for hepatitis C a few months later, said he knew only about treatment with interferon and ribavirin, older drugs that often caused depression, fatigue, nausea and other debilitating side effects.
“They said my levels were real low,” he said, recalling a doctor’s appointment last year, “so I just keep praying about it.”
Mr. Searp, 34, of Crescent Spring, believes he knows exactly when he contracted the virus: while shooting up with a friend in a house frequented by addicts.
“I asked to use his needle and he said, ‘Hey, I’ve got hep B and C,’ ” Mr. Searp said. “And at the time it didn’t really matter to me. The desire to get high was just so great.”
Mr. Wayman, a warehouse worker, said his doctor was trying to persuade his insurer to pay for one of the new drugs, which were not yet available the first time he sought treatment. He hopes to qualify for the new treatment before December, when he will turn 26 and no longer be covered by his parents’ health insurance.
“It’s in my past and I don’t want my past to haunt me,” he said. “I’m just waiting on that phone call.”
In Crestview Hills, outside Cincinnati, Dr. Thomas Schussler has 25 patients receiving treatment for hepatitis C and another 140 patients waiting for it, typically because their insurer has not yet approved it or because they are still using drugs. Dr. Schussler said private insurance is more likely to cover the cost, but only about 20 percent of his patients have it. The success rate with the new drugs is remarkable, he said, but he added, “The problem is we’re not getting anywhere. You could eradicate this if the drugs were ubiquitous and cheap.”
Lynne Saddler, who leads the Northern Kentucky Health Department, is pursuing another avenue for getting a handle on the epidemic: starting a needle exchange so that addicts in the region might stop infecting each other. This year, the Kentucky General Assembly passed a law aimed at combating the state’s growing heroin problem, with a provision that allows local jurisdictions to open exchanges.
Louisville became the first city in Kentucky to take advantage of the new law last month. Needle exchanges are also in the works in several counties in Indiana, Ohio and West Virginia. The Northern Kentucky District Board of Health voted last month to move forward with an exchange, but it still must win approval from any city or county in which the exchange has a location. Ms. Saddler is trying to build support for it, including among opponents who believe needle exchanges only encourage drug use.
“This really is our window of opportunity,” she said. “When you lay that out for people — look, we have a statutory responsibility to prevent the spread of diseases like this and here is a very effective tool — they start getting it.”
06 July 2015
VICTIMS LINE UP FOR CANCER DOCTOR'S SENTENCING
Original Story: detroitnews.com
Geraldine Parkin will face cancer doctor Farid Fata in Detroit federal court on Monday morning, as she and 24 other victims or family members of victims prepare to make statements as part of the cancer doctor's sentencing hearing. A Detroit health care lawyer has experience with multiple industry types and implications of detrimental health care practices or incidents.
"For me, I want the pleasure of looking him in the eye," says Parkin, who says her husband, Tim Parkin, is largely disabled as a result of his treatment. Fata once looked into her eyes and those of her adult children, insisting that her husband needed chemotherapy. Now she is ready to respond.
"I want to say to him, 'You gave us a life of the unknown, of misery, and now you're going to have a life behind bars.' "
The hearing, which is expected to last all week, likely will conclude with Judge Paul D. Borman sentencing Fata, who faces life in prison for his crimes. About 150 victims filed victim impact statements with the court. A Detroit medical malpractice lawyer is following this story closely.
Fata's north Oakland County cancer treatment empire collapsed after his arrest two years ago. He pleaded guilty to 16 counts of fraud in September.
But fraud doesn't accurately describe Fata's crimes, victims and former associates say, and victims are being allowed to speak in open court. While that's common in other kinds of criminal trials, it's unusual in a sentencing proceeding for victims of Medicare fraud.
In this case, though, some of Fata's patients were given chemotherapy treatments, some for years, after false or inflated cancer diagnoses by Fata. Many others were treated, and billed for, drugs on schedules designed for profitability rather than therapeutic value. The government has estimated there are at leat 550 people who were victimized by the doctor.
"Whether they were cancer or non-cancer patients, solid tumor or liquid, Fata did not discriminate: his ultimate goal was to maximize his profit on the backs of his patients," federal prosecutors argued in a sentencing memorandum.
Fata has been compared by government lawyers to financial fraudster Bernard Madoff for the brazen scope of his crimes and his willingness to prey on those who trusted him. At least two expert medical witnesses for the government are scheduled to testify during the sentencing hearing. An expert for the defense who reviewed some of Fata's cases defended the treatment of 17 out of 20 cases — but could not defend the rest. A Detroit negligence lawyer is experienced in the effective resolution of negligence lawsuits as related to improper care or practice in a professional setting.
About 40 members of the victims' group are traveling to the courthouse in a chartered bus, wearing special T-shirts and buttons emblazoned with the slogan "Army of One," united in their quest for justice and their shared experience. Speakers are allotted 10 minutes each to make their statements.
But beyond the hearing, complex issues of compensation for the victims remain. About 40 lawsuits are pending in Oakland County Circuit Court. Borman will hold a restitution hearing at least 90 days after Fata's sentencing to adjudicate the distribution of assets. The government has claimed Medicare is owed $34 million.
In addition to Medicare and former patients, private insurance companies, including Blue Cross/Blue Shield of Michigan, and a former employee turned whistle-blower have a financial stake in the outcome.
Compensation even for the most devastated victims is not clear-cut. Some couldn't file lawsuits because the statute of limitations had expired by the time Fata was arrested, says Donna MacKenzie, of Olsman Mueller Wallace & MacKenzie, a Ferndale law firm handling 13 cases against Fata and his practice. Many others who were harmed were turned away, for various reasons, because of the cost of litigating their claims.
Brian McKeen, who represents other former patients, says Fata's practice was "drastically under-insured" for a total of $3.6 million. Victims say they've been told the government has recovered about $10 million in assets.
"I'm on a mission to make the public realize how heavily the justice system is skewed toward providers and against the plaintiffs, the victims," he said. "Nobody cares about victim's rights until they become a victim."
Fata's arrest was triggered two years ago, on August 2, 2013, when the clinic's practice business manager, George Karadsheh, notified the FBI of Fata's potential crimes. On Aug. 5, 2013, Karadsheh officially filed a so-called qui tam or whistle-blower lawsuit in federal court. The FBI then interviewed Dr. Soe Maunglay, an oncologist at the clinic who had reported his concerns to Karadsheh. Fata was arrested the following morning.
Karadsheh's identity became public June 10, when a Detroit News article named him as the Fata practice insider who first called the FBI. The government subsequently unsealed the lawsuit.
"I've handled a lot of Medicare fraud but this is unspeakable," says David Haron, Karadsheh's lawyer. "Mr. Karadsheh has incredible concern for the patients. He lost his job but they lost so much more."
Parkin, the wife of a victim, knows her family will never regain what they have lost. "For us, the hearing is important because we don't want this to go down in history as fraud," she says. "We want it to go down as murder."
Geraldine Parkin will face cancer doctor Farid Fata in Detroit federal court on Monday morning, as she and 24 other victims or family members of victims prepare to make statements as part of the cancer doctor's sentencing hearing. A Detroit health care lawyer has experience with multiple industry types and implications of detrimental health care practices or incidents.
"For me, I want the pleasure of looking him in the eye," says Parkin, who says her husband, Tim Parkin, is largely disabled as a result of his treatment. Fata once looked into her eyes and those of her adult children, insisting that her husband needed chemotherapy. Now she is ready to respond.
"I want to say to him, 'You gave us a life of the unknown, of misery, and now you're going to have a life behind bars.' "
The hearing, which is expected to last all week, likely will conclude with Judge Paul D. Borman sentencing Fata, who faces life in prison for his crimes. About 150 victims filed victim impact statements with the court. A Detroit medical malpractice lawyer is following this story closely.
Fata's north Oakland County cancer treatment empire collapsed after his arrest two years ago. He pleaded guilty to 16 counts of fraud in September.
But fraud doesn't accurately describe Fata's crimes, victims and former associates say, and victims are being allowed to speak in open court. While that's common in other kinds of criminal trials, it's unusual in a sentencing proceeding for victims of Medicare fraud.
In this case, though, some of Fata's patients were given chemotherapy treatments, some for years, after false or inflated cancer diagnoses by Fata. Many others were treated, and billed for, drugs on schedules designed for profitability rather than therapeutic value. The government has estimated there are at leat 550 people who were victimized by the doctor.
"Whether they were cancer or non-cancer patients, solid tumor or liquid, Fata did not discriminate: his ultimate goal was to maximize his profit on the backs of his patients," federal prosecutors argued in a sentencing memorandum.
Fata has been compared by government lawyers to financial fraudster Bernard Madoff for the brazen scope of his crimes and his willingness to prey on those who trusted him. At least two expert medical witnesses for the government are scheduled to testify during the sentencing hearing. An expert for the defense who reviewed some of Fata's cases defended the treatment of 17 out of 20 cases — but could not defend the rest. A Detroit negligence lawyer is experienced in the effective resolution of negligence lawsuits as related to improper care or practice in a professional setting.
About 40 members of the victims' group are traveling to the courthouse in a chartered bus, wearing special T-shirts and buttons emblazoned with the slogan "Army of One," united in their quest for justice and their shared experience. Speakers are allotted 10 minutes each to make their statements.
But beyond the hearing, complex issues of compensation for the victims remain. About 40 lawsuits are pending in Oakland County Circuit Court. Borman will hold a restitution hearing at least 90 days after Fata's sentencing to adjudicate the distribution of assets. The government has claimed Medicare is owed $34 million.
In addition to Medicare and former patients, private insurance companies, including Blue Cross/Blue Shield of Michigan, and a former employee turned whistle-blower have a financial stake in the outcome.
Compensation even for the most devastated victims is not clear-cut. Some couldn't file lawsuits because the statute of limitations had expired by the time Fata was arrested, says Donna MacKenzie, of Olsman Mueller Wallace & MacKenzie, a Ferndale law firm handling 13 cases against Fata and his practice. Many others who were harmed were turned away, for various reasons, because of the cost of litigating their claims.
Brian McKeen, who represents other former patients, says Fata's practice was "drastically under-insured" for a total of $3.6 million. Victims say they've been told the government has recovered about $10 million in assets.
"I'm on a mission to make the public realize how heavily the justice system is skewed toward providers and against the plaintiffs, the victims," he said. "Nobody cares about victim's rights until they become a victim."
Fata's arrest was triggered two years ago, on August 2, 2013, when the clinic's practice business manager, George Karadsheh, notified the FBI of Fata's potential crimes. On Aug. 5, 2013, Karadsheh officially filed a so-called qui tam or whistle-blower lawsuit in federal court. The FBI then interviewed Dr. Soe Maunglay, an oncologist at the clinic who had reported his concerns to Karadsheh. Fata was arrested the following morning.
Karadsheh's identity became public June 10, when a Detroit News article named him as the Fata practice insider who first called the FBI. The government subsequently unsealed the lawsuit.
"I've handled a lot of Medicare fraud but this is unspeakable," says David Haron, Karadsheh's lawyer. "Mr. Karadsheh has incredible concern for the patients. He lost his job but they lost so much more."
Parkin, the wife of a victim, knows her family will never regain what they have lost. "For us, the hearing is important because we don't want this to go down in history as fraud," she says. "We want it to go down as murder."
FORMER DMC CHIEF DIES IN PANAMA AMID KICKBACK PROBE
Original Story: freep.com
A former head of the Detroit Medical Center who was later charged in one of the largest fraud and corruption investigations in Canadian history has died in custody in Panama.
Dr. Arthur Porter, 59, CEO of DMC from 1999 through 2003, died Wednesday of cancer while under armed guard in a Panama City hospital. The death was announced by Porter's biographer, Jeff Todd, who said the cause was lung cancer that had spread to the bone and liver.
Before his transfer to the hospital this spring, Porter had been in Panama's La Joya Prison following his 2013 arrest in that country on fraud, conspiracy and money laundering charges related to the construction of a $1.3 billion so-called super hospital in Montreal. A Birmingham criminal lawyer is following this story closely.
Porter, who left the DMC to head McGill University's hospital network, was accused of taking as much as $22.5 million in bribes in a kickback scheme for the super hospital's construction contract.
At least seven other individuals also faced criminal charges for the kickback allegations, according to the Montreal Gazette.
The newspaper reported that Porter's extradition to Quebec had been put on hold earlier this year as his lawyer challenged his detention in prison. It does not appear that Porter ever faced trial for the allegations.
A spokeswoman for the Canadian Department of Foreign Affairs would not comment Wednesday night on any specifics of Porter's case. A Harrisonburg white collar crime lawyer is experienced in the effective resolution of white collar crime lawsuits as related to business related crimes.
A native of Sierra Leone, Porter was a radiation oncology specialist who became CEO of DMC in May 1999, when the then-struggling hospital system was burning through nearly $100 million a year. Although he slashed thousands of jobs, consolidated hospitals and sold off clinics, DMC was still a money-loser by September 2003, when Porter resigned under pressure.
In a memoir released last year that he wrote while in prison, Porter claimed that in 2001, he received a phone call from President George W. Bush offering him the job of U.S. Surgeon General, according to the Montreal Gazette. Porter declined Bush's offer.
Porter left the U.S. in 2004 to become executive director of McGill University's hospital network. In 2008, he was named to a seat on Canada's spy agency watchdog committee, gaining access to Canadian state secrets.
At the time of Porter's arrest in 2013, DMC officials told the Free Press that he was never suspected or accused of any wrongdoing during his years in Detroit. He arrived in Detroit in 1991 as a member of the radiation oncology department at the DMC-affiliated Wayne State University School of Medicine.
"We certainly didn't see any behavior that would have caused us to believe he was involved in improper activities," a former DMC board member, Stephen D'Arcy, said at the time. "It's almost bizarre the kinds of things he was involved in apparently in Canada."
A DMC spokesperson could not be reached for comment late Wednesday.
According to Porter's biographer, Porter was forced to smuggle chemotherapy drugs into prison to keep himself alive and, despite repeated letters to the Canadian embassy in Panama for better medical care, wasn't granted access to cancer treatment until this year.
He spent his final days on high doses of morphine for the pain, his biographer wrote in a statement posted online.
The Montreal Gazette reported that Porter's wife pleaded guilty in December to money laundering and was sentenced to two years in prison. A San Francisco corporate lawyer represents clients in corporate criminal charges and corporate finance cases.
In attempts to recover $17.5 million of the $22.5 million that was allegedly defrauded, Quebec authorities have seized properties belonging to Porter and his family in Michigan, Florida and the Caribbean and bank accounts in the U.S. and other countries, the newspaper said.
A former head of the Detroit Medical Center who was later charged in one of the largest fraud and corruption investigations in Canadian history has died in custody in Panama.
Dr. Arthur Porter, 59, CEO of DMC from 1999 through 2003, died Wednesday of cancer while under armed guard in a Panama City hospital. The death was announced by Porter's biographer, Jeff Todd, who said the cause was lung cancer that had spread to the bone and liver.
Before his transfer to the hospital this spring, Porter had been in Panama's La Joya Prison following his 2013 arrest in that country on fraud, conspiracy and money laundering charges related to the construction of a $1.3 billion so-called super hospital in Montreal. A Birmingham criminal lawyer is following this story closely.
Porter, who left the DMC to head McGill University's hospital network, was accused of taking as much as $22.5 million in bribes in a kickback scheme for the super hospital's construction contract.
At least seven other individuals also faced criminal charges for the kickback allegations, according to the Montreal Gazette.
The newspaper reported that Porter's extradition to Quebec had been put on hold earlier this year as his lawyer challenged his detention in prison. It does not appear that Porter ever faced trial for the allegations.
A spokeswoman for the Canadian Department of Foreign Affairs would not comment Wednesday night on any specifics of Porter's case. A Harrisonburg white collar crime lawyer is experienced in the effective resolution of white collar crime lawsuits as related to business related crimes.
A native of Sierra Leone, Porter was a radiation oncology specialist who became CEO of DMC in May 1999, when the then-struggling hospital system was burning through nearly $100 million a year. Although he slashed thousands of jobs, consolidated hospitals and sold off clinics, DMC was still a money-loser by September 2003, when Porter resigned under pressure.
In a memoir released last year that he wrote while in prison, Porter claimed that in 2001, he received a phone call from President George W. Bush offering him the job of U.S. Surgeon General, according to the Montreal Gazette. Porter declined Bush's offer.
Porter left the U.S. in 2004 to become executive director of McGill University's hospital network. In 2008, he was named to a seat on Canada's spy agency watchdog committee, gaining access to Canadian state secrets.
At the time of Porter's arrest in 2013, DMC officials told the Free Press that he was never suspected or accused of any wrongdoing during his years in Detroit. He arrived in Detroit in 1991 as a member of the radiation oncology department at the DMC-affiliated Wayne State University School of Medicine.
"We certainly didn't see any behavior that would have caused us to believe he was involved in improper activities," a former DMC board member, Stephen D'Arcy, said at the time. "It's almost bizarre the kinds of things he was involved in apparently in Canada."
A DMC spokesperson could not be reached for comment late Wednesday.
According to Porter's biographer, Porter was forced to smuggle chemotherapy drugs into prison to keep himself alive and, despite repeated letters to the Canadian embassy in Panama for better medical care, wasn't granted access to cancer treatment until this year.
He spent his final days on high doses of morphine for the pain, his biographer wrote in a statement posted online.
The Montreal Gazette reported that Porter's wife pleaded guilty in December to money laundering and was sentenced to two years in prison. A San Francisco corporate lawyer represents clients in corporate criminal charges and corporate finance cases.
In attempts to recover $17.5 million of the $22.5 million that was allegedly defrauded, Quebec authorities have seized properties belonging to Porter and his family in Michigan, Florida and the Caribbean and bank accounts in the U.S. and other countries, the newspaper said.
24 June 2015
HEALTH OFFICIALS WARN OF FLESH-EATING BACTERIA IN FLORIDA
Original Story: chicagotribune.com
Florida health officials are warning residents and tourists a rare form of flesh-eating, potentially deadly bacteria has made its way to Florida beaches. If you may have been exposed to this deadly bacteria, seek emergency medical attention.
The Vibrio vulnificus bacterium grows fastest in warm saltwater and has already infected at least seven people, killing two this year in Florida. The state health department says there have been 32 cases in the past 12 months. Officials say a spike in cases occurs from May to October when water is the warmest.
Florida Health Department spokeswoman Mara Burger says consuming or handling raw shellfish and swimming in warm saltwater can put people at risk. People with open wounds can also be exposed to Vibrio vulnificus through direct contact with seawater. For expert medical care, trust DMC for your emergency care needs.
The bacterial infection can cause gastroenteritis, sepsis and can lead to amputation.
Florida health officials are warning residents and tourists a rare form of flesh-eating, potentially deadly bacteria has made its way to Florida beaches. If you may have been exposed to this deadly bacteria, seek emergency medical attention.
The Vibrio vulnificus bacterium grows fastest in warm saltwater and has already infected at least seven people, killing two this year in Florida. The state health department says there have been 32 cases in the past 12 months. Officials say a spike in cases occurs from May to October when water is the warmest.
Florida Health Department spokeswoman Mara Burger says consuming or handling raw shellfish and swimming in warm saltwater can put people at risk. People with open wounds can also be exposed to Vibrio vulnificus through direct contact with seawater. For expert medical care, trust DMC for your emergency care needs.
The bacterial infection can cause gastroenteritis, sepsis and can lead to amputation.
19 June 2015
DETROIT AREA DOCTOR COULD FORFEIT COIN TROVE WORTH MILLIONS IN FRAUD CASE
Original Story: detroitnews.com
A West Bloomfield neurologist who reaped millions by allegedly cheating Medicare spent more than $9.3 million on baseball cards, ancient coins, collectable currency and stamps — a rare collection he could soon lose to the government. A medical malpractice lawyer is reviewing the details of this case.
Dr. Gavin Awerbuch amassed the collection — including coins from ancient Rome — using cash generated by an alleged five-year crime wave, according to federal court records that offer rare insight into the secretive world of coin collecting. At the upper end, the world is filled with hobbyists who, due to security concerns, protect the scope and value of their prized possessions.
Awerbuch's case shows a unique twist on a growing trend of health care professionals nationwide accused of spending money from fraudulent activities on valuable possessions, including homes and automobiles.
"This flabbergasts me. I never knew that his firepower extended that far," said Metro Detroit currency dealer Frederick Bart, who sold the doctor $360,225 worth of collectable currency printed before 1928. "He didn't have a target on his back where you thought 'here comes moneybags.' "
Federal prosecutors want the collection — experts say it could be among the richest in Michigan — forfeited to the government, along with $2.9 million in cash and a million-dollar Arizona vacation home.
Awerbuch, 57, is free on $10,000 unsecured bond. If convicted, he faces 10 years or more in federal prison. A preliminary exam has been set for June 29.
Though court records do not specify exactly which collectible items Awerbuch purchased, the extent of his coin collection is emerging more than one year after he was charged with health care fraud and distribution of controlled substances. A Medicaid and Medicare lawyer is following this story closely.
He was accused of defrauding Medicare of $7 million and prescribing so much of the cancer painkiller Subsys that he was the top dispenser in the country, according to the U.S. Attorney's Office.
Awerbuch's defense lawyer, Mark Kriger, declined comment.
Newly filed court records show how Awerbuch spent money generated by allegedly fraudulent activity.
"(Sizable) purchases were made with dealers of rare and collectible coins, as well as dealers of other types of collectible items," Assistant U.S. Attorney Jonathan Grey wrote in a court filing. "These assets were purchased, at least in part, with criminally derived proceeds commingled in Awerbuch's various accounts." A Detroit insurance defense lawyer represents insurers in insurance fraud cases.
From 2008 through 2013, Awerbuch spent $9,343,527 at more than a dozen coin and collectible dealers in Michigan and across the country, according to court records.
The bulk, $7 million, was spent at Kagin's Inc. The California firm deals in rare coins, such as a pioneer gold coin for $999,999 and the first coin struck in North America, a shilling priced at $299,500.
"He was a good client," company President Donald Kagin told The News this week. "Over the years, we've had good transactions with him with different types of coins."
Kagin would not reveal what Awerbuch bought from his store, citing client confidentiality.
The collectibles Awerbuch purchased were spread across several locations. Federal agents struck gold — literally — during searches at several locations.
Investigators found gold and silver coins at his medical office in Saginaw, along with Roman coins honoring Emperors Titus and Claudius.
"If they are in nice condition, those can go for many thousands of dollars, and do," said Thomas Klunzinger, who serves on the board of the Michigan State Numismatic Society, which encourages and promotes the study and collection of currency. "Every dye was different. If you have a Roman coin, maybe it was highlighting some battle or commemorating a victory. Those (coins) were the media of the day."
Investigators also found a coin from ancient Judea, according to a search warrant inventory.
At his $1.1 million West Bloomfield home overlooking Upper Straits Lake, investigators found boxes of coins, stamps and Costa Rican currency, prosecutors allege.
Awerbuch stashed more coins, collectible currency, baseball cards, jewelry and stamps in at least 16 safe deposit boxes at PNC and Fifth Third banks, according to court records.
On Thursday, federal prosecutors asked a judge to have the coins and collectibles forfeited to the government, alleging the items were purchased with proceeds of a crime.
Federal prosecutors have not itemized the individual pieces of Awerbuch's collection.
Just a few coins could be worth millions, said Julianna Wostyn, president of the Michigan State Numismatic Society.
"You can spend a horrendous amount of money, and it doesn't have to be gold," she said. "When you're talking paper money, in the last 10 years, paper money has skyrocketed."
She has never heard of Awerbuch or met him at area conventions.
"People don't want to make themselves known," she said. "Number one: They don't want to be knocked over. I won't say they look homeless, but coin collectors are not flashy people and do not go about bragging about themselves."
Besides the coins, prosecutors want to keep almost $3 million seized from Awerbuch's bank accounts.
The money includes $622,800 seized after Awerbuch sold his home in July 2014.
Prosecutors also want the doctor to forfeit his home in the Arizona desert, saying it was purchased with money generated by health care fraud and unlawfully distributing prescription drugs. An insurance defense lawyer represents insurance companies in disputes and fraud cases.
His ex-wife is fighting the request, saying she is the innocent owner of the 4,700-square-foot home, which has a putting green, wine room, outdoor pool and waterfall.
Awerbuch bought the home two years ago for $940,000, according to court records.
He paid cash.
A West Bloomfield neurologist who reaped millions by allegedly cheating Medicare spent more than $9.3 million on baseball cards, ancient coins, collectable currency and stamps — a rare collection he could soon lose to the government. A medical malpractice lawyer is reviewing the details of this case.
Dr. Gavin Awerbuch amassed the collection — including coins from ancient Rome — using cash generated by an alleged five-year crime wave, according to federal court records that offer rare insight into the secretive world of coin collecting. At the upper end, the world is filled with hobbyists who, due to security concerns, protect the scope and value of their prized possessions.
Awerbuch's case shows a unique twist on a growing trend of health care professionals nationwide accused of spending money from fraudulent activities on valuable possessions, including homes and automobiles.
"This flabbergasts me. I never knew that his firepower extended that far," said Metro Detroit currency dealer Frederick Bart, who sold the doctor $360,225 worth of collectable currency printed before 1928. "He didn't have a target on his back where you thought 'here comes moneybags.' "
Federal prosecutors want the collection — experts say it could be among the richest in Michigan — forfeited to the government, along with $2.9 million in cash and a million-dollar Arizona vacation home.
Awerbuch, 57, is free on $10,000 unsecured bond. If convicted, he faces 10 years or more in federal prison. A preliminary exam has been set for June 29.
Though court records do not specify exactly which collectible items Awerbuch purchased, the extent of his coin collection is emerging more than one year after he was charged with health care fraud and distribution of controlled substances. A Medicaid and Medicare lawyer is following this story closely.
He was accused of defrauding Medicare of $7 million and prescribing so much of the cancer painkiller Subsys that he was the top dispenser in the country, according to the U.S. Attorney's Office.
Awerbuch's defense lawyer, Mark Kriger, declined comment.
Newly filed court records show how Awerbuch spent money generated by allegedly fraudulent activity.
"(Sizable) purchases were made with dealers of rare and collectible coins, as well as dealers of other types of collectible items," Assistant U.S. Attorney Jonathan Grey wrote in a court filing. "These assets were purchased, at least in part, with criminally derived proceeds commingled in Awerbuch's various accounts." A Detroit insurance defense lawyer represents insurers in insurance fraud cases.
From 2008 through 2013, Awerbuch spent $9,343,527 at more than a dozen coin and collectible dealers in Michigan and across the country, according to court records.
The bulk, $7 million, was spent at Kagin's Inc. The California firm deals in rare coins, such as a pioneer gold coin for $999,999 and the first coin struck in North America, a shilling priced at $299,500.
"He was a good client," company President Donald Kagin told The News this week. "Over the years, we've had good transactions with him with different types of coins."
Kagin would not reveal what Awerbuch bought from his store, citing client confidentiality.
The collectibles Awerbuch purchased were spread across several locations. Federal agents struck gold — literally — during searches at several locations.
Investigators found gold and silver coins at his medical office in Saginaw, along with Roman coins honoring Emperors Titus and Claudius.
"If they are in nice condition, those can go for many thousands of dollars, and do," said Thomas Klunzinger, who serves on the board of the Michigan State Numismatic Society, which encourages and promotes the study and collection of currency. "Every dye was different. If you have a Roman coin, maybe it was highlighting some battle or commemorating a victory. Those (coins) were the media of the day."
Investigators also found a coin from ancient Judea, according to a search warrant inventory.
At his $1.1 million West Bloomfield home overlooking Upper Straits Lake, investigators found boxes of coins, stamps and Costa Rican currency, prosecutors allege.
Awerbuch stashed more coins, collectible currency, baseball cards, jewelry and stamps in at least 16 safe deposit boxes at PNC and Fifth Third banks, according to court records.
On Thursday, federal prosecutors asked a judge to have the coins and collectibles forfeited to the government, alleging the items were purchased with proceeds of a crime.
Federal prosecutors have not itemized the individual pieces of Awerbuch's collection.
Just a few coins could be worth millions, said Julianna Wostyn, president of the Michigan State Numismatic Society.
"You can spend a horrendous amount of money, and it doesn't have to be gold," she said. "When you're talking paper money, in the last 10 years, paper money has skyrocketed."
She has never heard of Awerbuch or met him at area conventions.
"People don't want to make themselves known," she said. "Number one: They don't want to be knocked over. I won't say they look homeless, but coin collectors are not flashy people and do not go about bragging about themselves."
Besides the coins, prosecutors want to keep almost $3 million seized from Awerbuch's bank accounts.
The money includes $622,800 seized after Awerbuch sold his home in July 2014.
Prosecutors also want the doctor to forfeit his home in the Arizona desert, saying it was purchased with money generated by health care fraud and unlawfully distributing prescription drugs. An insurance defense lawyer represents insurance companies in disputes and fraud cases.
His ex-wife is fighting the request, saying she is the innocent owner of the 4,700-square-foot home, which has a putting green, wine room, outdoor pool and waterfall.
Awerbuch bought the home two years ago for $940,000, according to court records.
He paid cash.
09 June 2015
NO-CONSENT MEDICAL EXPERIMENTS PUT ETHICS TO TEST
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."
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.
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