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.
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.
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