GSK pumps $29M into infectious disease R&D hub in Beijing
Link to full article
Lead Author: EJ Lane
FiercePharmaAsia, 2016-03-31
GlaxoSmithKline ($GSK) will pump in $29 million for a Beijing-based R&D institute to tackle infectious disease and antibiotic resistance health threats in China by working in tandem with academics and regulators.
The Institute for Infectious Diseases and Public Health will draw on 20 in-house GSK researchers to start and will look to existing drugs in the U.K. drugmaker's portfolio as well as clinical trial stage work on HIV and multidrug-resistant bacterial infections, China Daily reported.
"GSK has made a commitment to China and its people, we will be a company 'In China, With China, and For China' setting new standards as a responsible multinational operating in the country," GSK CEO Andrew Witty told the newspaper.
"GSK is well positioned to be a catalyst in creating high impact scientific partnerships that can address public health issues by driving joint scientific research; and improving global coordination in addressing major health challenges."
GSK has taken a number of steps to deepen ties to Chinese companies and academics since it paid a whopping $489 million fine in 2015 after pleading guilty to bribing doctors and healthcare executives to buy its drugs.
GSK's ViiV Healthcare unit last year signed a deal to have Shanghai-based Desano Pharmaceuticals manufacture HIV therapy Tivicay, setting the stage for greater access at lower cost.
Multidrug-resistant TB (MDR-TB) fits in with areas of preclinical development for GSK and high unmet medical need in China with nearly 930,000 patients diagnosed with TB in China in 2014, according to China Daily.
GSK in 2014 began work with Switzerland's BioVersys and France's University of Lille to develop a new preclinical candidate against MDR-TB. The China Daily story said GSK intends to file its primary new drug application in China if its candidate makes the grade, though it did not name the therapy.
A spokesman for GSK was not immediately available to clarify.
A Xinhua story this month also pointed out that the country has had some success in the area. New infection rates for tuberculosis in China have dropped, the National Health and Family Planning Commission said, bolstering a trend that has seen morbidity decline to 63.4 in 100,000 in 2015 from 71.1 in 100,000 in 2011.
On antibiotic resistance, China has been regularly identified along with India as a hotspot of overprescription and potential environmental contamination from haphazard antibiotic manufacture.
"Antimicrobial resistance is a serious healthcare problem in China with high resistance rates of most common bacteria to clinically important antimicrobial agents," Patrick Vallance, president, Pharmaceuticals R&D at GSK, told the newspaper.
"As the current chair of the G20, China is ideally placed to catalyze global efforts in combating antimicrobial resistance."
The institute will be led by Zhi Hong, senior vice president and head of the Infectious Diseases R&D Unit at GSK. He will split his time between the institute and his base in the U.S., China Daily said.
A GSK R&D shop set up in Shanghai in 2007 has been a mainstay of drug development efforts in China, though there was a hiccup in 2013 over allegations that a key researcher misrepresented data from an autoimmune study published in Nature Medicine that was eventually retracted.
MIB Abstract ID Number: 22303
GSK pumps $29M into infectious disease R&D hub in Beijing
Link to full article
Lead Author: EJ Lane
FiercePharmaAsia, 2016-03-31
GlaxoSmithKline ($GSK) will pump in $29 million for a Beijing-based R&D institute to tackle infectious disease and antibiotic resistance health threats in China by working in tandem with academics and regulators.
The Institute for Infectious Diseases and Public Health will draw on 20 in-house GSK researchers to start and will look to existing drugs in the U.K. drugmaker's portfolio as well as clinical trial stage work on HIV and multidrug-resistant bacterial infections, China Daily reported.
"GSK has made a commitment to China and its people, we will be a company 'In China, With China, and For China' setting new standards as a responsible multinational operating in the country," GSK CEO Andrew Witty told the newspaper.
"GSK is well positioned to be a catalyst in creating high impact scientific partnerships that can address public health issues by driving joint scientific research; and improving global coordination in addressing major health challenges."
GSK has taken a number of steps to deepen ties to Chinese companies and academics since it paid a whopping $489 million fine in 2015 after pleading guilty to bribing doctors and healthcare executives to buy its drugs.
GSK's ViiV Healthcare unit last year signed a deal to have Shanghai-based Desano Pharmaceuticals manufacture HIV therapy Tivicay, setting the stage for greater access at lower cost.
Multidrug-resistant TB (MDR-TB) fits in with areas of preclinical development for GSK and high unmet medical need in China with nearly 930,000 patients diagnosed with TB in China in 2014, according to China Daily.
GSK in 2014 began work with Switzerland's BioVersys and France's University of Lille to develop a new preclinical candidate against MDR-TB. The China Daily story said GSK intends to file its primary new drug application in China if its candidate makes the grade, though it did not name the therapy.
A spokesman for GSK was not immediately available to clarify.
A Xinhua story this month also pointed out that the country has had some success in the area. New infection rates for tuberculosis in China have dropped, the National Health and Family Planning Commission said, bolstering a trend that has seen morbidity decline to 63.4 in 100,000 in 2015 from 71.1 in 100,000 in 2011.
On antibiotic resistance, China has been regularly identified along with India as a hotspot of overprescription and potential environmental contamination from haphazard antibiotic manufacture.
"Antimicrobial resistance is a serious healthcare problem in China with high resistance rates of most common bacteria to clinically important antimicrobial agents," Patrick Vallance, president, Pharmaceuticals R&D at GSK, told the newspaper.
"As the current chair of the G20, China is ideally placed to catalyze global efforts in combating antimicrobial resistance."
The institute will be led by Zhi Hong, senior vice president and head of the Infectious Diseases R&D Unit at GSK. He will split his time between the institute and his base in the U.S., China Daily said.
A GSK R&D shop set up in Shanghai in 2007 has been a mainstay of drug development efforts in China, though there was a hiccup in 2013 over allegations that a key researcher misrepresented data from an autoimmune study published in Nature Medicine that was eventually retracted.
MIB Abstract ID Number: 22303
Abbott Faces $1 Billion Claim in Trial Over Stent Marketing
Link to full article
Lead Author: Margaret Cronin Fisk
Additional Authors: Tom Korosec, Michelle Cortez, & FayCortez (tweet)
Bloomberg, 2016-03-29
Abbott Laboratories is accused in a trial that started Tuesday of marketing unapproved stents for unsuspecting patients and cheating Medicare as a whistle-blower seeks more than $1 billion, a risk the company hasn’t fully disclosed to shareholders.
The company faces allegations it increased sales by marketing devices for uses that weren’t approved by the U.S. Food and Drug Administration. Kevin Colquitt, a former salesman for Abbott and Guidant turned whistle-blower, claims it pushed bile-duct stents, intended for short-term purposes, for more complex vascular use.
The drugmaker didn’t conduct a clinical trial on the safety, instead using so-called off-label marketing to test devices on patients without their informed consent, Colquitt claims. Multiple patients suffered complications including fractures of the devices after implantation, stroke, infections and migration of the stents, he alleges.
The company conducted an “experiment on senior citizens” and a “fraud” on the Medicare system, Chris Hamilton, Colquitt’s lawyer, said Tuesday in court. Abbott “hid the paper trail and buried evidence of malfunctions,” including the case of an elderly man who lost his leg and then died after a stent was placed in him, Hamilton said in his opening statement to the jury.
Rewriting History
Abbott, which acquired Guidant’s stent business in 2006, denies the claims and calls the lawsuit an attempt to “rewrite history.’’ The use of biliary, or bile duct, stents to treat peripheral vascular or arterial disease was “a generally accepted medical practice and indeed, standard of care,’’ Abbott lawyers said in court papers.
“To give patients the best care, the government chose to reimburse for the off-label use of biliary stents,” James Hurst, Abbott’s lawyer, told jurors Tuesday in Dallas. “It was with complete knowledge.”
During the period covered in the lawsuit, the FDA’s system for giving approval to vascular stents was broken, he said. “It had been broken since the ’90s.” By the time stents went through three to six years of clinical trials and testing, they were outdated, he said.
‘Best Technology’
“Doctors demanded the latest and best technology for their patients,” Hurst said. Biliary stents provided the latest technology, he said. “Who is going to buy the iPhone 3g when there’s an iPhone 6 available?” he asked.
“Nobody was harmed,” he said. “When the government paid for these procedures, they were getting exactly what they paid for –- care for our seniors.”
Darcy Ross, a company spokeswoman, called the suit meritless. “Physicians have chosen to use biliary stents in vascular stenting procedures as the standard of care for more than a decade,” Ross said by e-mail. “Reimbursement was not only permitted under the Medicare regulations but also the right decision for patients.”
The three-week federal court jury trial will cover some of the products at issue in Abbott’s $5.5 million settlement with the U.S. in 2013 over kickbacks paid to doctors to use stents. The Dallas suit focuses on off-label marketing, actively marketing a drug or device for an unapproved use.
Share of Damages
Colquitt sued in 2006 on behalf of the U.S. government, which declined to join the case. His lawyers continued to pursue the claim independently. Any damages would be awarded to the U.S., with Colquitt getting a share.
While Abbott since 2008 has disclosed legal cases surrounding the sales and marketing of its biliary stents in regulatory filings, it hasn’t indicated whether it has insurance or reserves for possible losses. None of the legal issues it faced was expected to have a material adverse effect on the company, it said.
The case may turn on what jurors think of claims that patients weren’t told the devices were unapproved, said Patrick Burns, of Taxpayers Against Fraud, a Washington advocacy group for whistle-blower laws including the federal False Claims Act under which the suit was filed.
“There is no need to prove that any individual was harmed,’’ he said in an interview. “But who would allow bile duct stents to be put in themselves or their mother or father if they weren’t FDA approved? If Abbott loses this case, they’re going to lose it big.’’
Court Rulings
U.S. District Judge Barbara Lynn in January rejected Abbott’s request to dismiss the case and denied Colquitt’s motion to find Abbott liable for making false claims before a trial.
Guidant “pursued a reimbursement-driven marketing strategy for off-label use of biliary stents that were not only unapproved for vascular indications, but carried an express warning from the FDA that the devices were not established to be safe or effective,’’ Colquitt’s lawyers said in an October filing.
The stents weren’t eligible for Medicare reimbursement because they weren’t approved for vascular use, according to the suit. About 99 percent of the bile-duct stents the company sold from 2004 to 2006, the time covered by the suit, were used off-label, according to an Abbott expert’s testimony, court papers show.
Ghostwritten Articles
The company ghostwrote doctors’ articles, used false advertising, sent letters on behalf of doctors to potential patients, paid millions of dollars to physicians to support the product and train other doctors, and taught hospitals and physicians how to enter codes resulting in Medicare reimbursements, Hamilton told jurors. Each of about 40,000 reimbursement claims was a false statement, Colquitt contends.
Colquitt’s damages expert estimated that off-label promotion caused the federal government to pay $214.7 million to $330.4 million for peripheral vascular stent procedures using unapproved stents. The U.S. paid $219 million for false claims covered by Colquitt’s case, his lawyer told the jury.
The False Claims Act allows any damages awarded by a jury to be tripled. The Colquitt suit also seeks fines of $5,500 to $11,000 for each of the alleged false claims.
Abbott denies that Medicare was fooled into paying for the stents or that such payments were barred.
Market Share
“Well over 95 percent” of vascular procedures used biliary stents from companies including Guidant in the time covered by the case, said Hurst, the company lawyer. Guidant had 15 to 20 percent of the market, he said.
Doctors are allowed to use devices for purposes that don’t have formal FDA approval. The agency warned them and device makers about the risks after receiving reports of hundreds of adverse events. An FDA analysis found that more than 90 percent of biliary stent injuries and malfunctions from 2001 to 2006 occurred when the devices were used in off-label procedures.
The case is U.S. ex rel. Colquitt v. Abbott Laboratories f/k/a Guidant Corp., 06-cv-01769, U.S. District Court, Northern District of Texas (Dallas).
MIB Abstract ID Number: 22306
Abbott Faces $1 Billion Claim in Trial Over Stent Marketing
Link to full article
Lead Author: Margaret Cronin Fisk
Additional Authors: Tom Korosec, Michelle Cortez, & FayCortez (tweet)
Bloomberg, 2016-03-29
Abbott Laboratories is accused in a trial that started Tuesday of marketing unapproved stents for unsuspecting patients and cheating Medicare as a whistle-blower seeks more than $1 billion, a risk the company hasn’t fully disclosed to shareholders.
The company faces allegations it increased sales by marketing devices for uses that weren’t approved by the U.S. Food and Drug Administration. Kevin Colquitt, a former salesman for Abbott and Guidant turned whistle-blower, claims it pushed bile-duct stents, intended for short-term purposes, for more complex vascular use.
The drugmaker didn’t conduct a clinical trial on the safety, instead using so-called off-label marketing to test devices on patients without their informed consent, Colquitt claims. Multiple patients suffered complications including fractures of the devices after implantation, stroke, infections and migration of the stents, he alleges.
The company conducted an “experiment on senior citizens” and a “fraud” on the Medicare system, Chris Hamilton, Colquitt’s lawyer, said Tuesday in court. Abbott “hid the paper trail and buried evidence of malfunctions,” including the case of an elderly man who lost his leg and then died after a stent was placed in him, Hamilton said in his opening statement to the jury.
Rewriting History
Abbott, which acquired Guidant’s stent business in 2006, denies the claims and calls the lawsuit an attempt to “rewrite history.’’ The use of biliary, or bile duct, stents to treat peripheral vascular or arterial disease was “a generally accepted medical practice and indeed, standard of care,’’ Abbott lawyers said in court papers.
“To give patients the best care, the government chose to reimburse for the off-label use of biliary stents,” James Hurst, Abbott’s lawyer, told jurors Tuesday in Dallas. “It was with complete knowledge.”
During the period covered in the lawsuit, the FDA’s system for giving approval to vascular stents was broken, he said. “It had been broken since the ’90s.” By the time stents went through three to six years of clinical trials and testing, they were outdated, he said.
‘Best Technology’
“Doctors demanded the latest and best technology for their patients,” Hurst said. Biliary stents provided the latest technology, he said. “Who is going to buy the iPhone 3g when there’s an iPhone 6 available?” he asked.
“Nobody was harmed,” he said. “When the government paid for these procedures, they were getting exactly what they paid for –- care for our seniors.”
Darcy Ross, a company spokeswoman, called the suit meritless. “Physicians have chosen to use biliary stents in vascular stenting procedures as the standard of care for more than a decade,” Ross said by e-mail. “Reimbursement was not only permitted under the Medicare regulations but also the right decision for patients.”
The three-week federal court jury trial will cover some of the products at issue in Abbott’s $5.5 million settlement with the U.S. in 2013 over kickbacks paid to doctors to use stents. The Dallas suit focuses on off-label marketing, actively marketing a drug or device for an unapproved use.
Share of Damages
Colquitt sued in 2006 on behalf of the U.S. government, which declined to join the case. His lawyers continued to pursue the claim independently. Any damages would be awarded to the U.S., with Colquitt getting a share.
While Abbott since 2008 has disclosed legal cases surrounding the sales and marketing of its biliary stents in regulatory filings, it hasn’t indicated whether it has insurance or reserves for possible losses. None of the legal issues it faced was expected to have a material adverse effect on the company, it said.
The case may turn on what jurors think of claims that patients weren’t told the devices were unapproved, said Patrick Burns, of Taxpayers Against Fraud, a Washington advocacy group for whistle-blower laws including the federal False Claims Act under which the suit was filed.
“There is no need to prove that any individual was harmed,’’ he said in an interview. “But who would allow bile duct stents to be put in themselves or their mother or father if they weren’t FDA approved? If Abbott loses this case, they’re going to lose it big.’’
Court Rulings
U.S. District Judge Barbara Lynn in January rejected Abbott’s request to dismiss the case and denied Colquitt’s motion to find Abbott liable for making false claims before a trial.
Guidant “pursued a reimbursement-driven marketing strategy for off-label use of biliary stents that were not only unapproved for vascular indications, but carried an express warning from the FDA that the devices were not established to be safe or effective,’’ Colquitt’s lawyers said in an October filing.
The stents weren’t eligible for Medicare reimbursement because they weren’t approved for vascular use, according to the suit. About 99 percent of the bile-duct stents the company sold from 2004 to 2006, the time covered by the suit, were used off-label, according to an Abbott expert’s testimony, court papers show.
Ghostwritten Articles
The company ghostwrote doctors’ articles, used false advertising, sent letters on behalf of doctors to potential patients, paid millions of dollars to physicians to support the product and train other doctors, and taught hospitals and physicians how to enter codes resulting in Medicare reimbursements, Hamilton told jurors. Each of about 40,000 reimbursement claims was a false statement, Colquitt contends.
Colquitt’s damages expert estimated that off-label promotion caused the federal government to pay $214.7 million to $330.4 million for peripheral vascular stent procedures using unapproved stents. The U.S. paid $219 million for false claims covered by Colquitt’s case, his lawyer told the jury.
The False Claims Act allows any damages awarded by a jury to be tripled. The Colquitt suit also seeks fines of $5,500 to $11,000 for each of the alleged false claims.
Abbott denies that Medicare was fooled into paying for the stents or that such payments were barred.
Market Share
“Well over 95 percent” of vascular procedures used biliary stents from companies including Guidant in the time covered by the case, said Hurst, the company lawyer. Guidant had 15 to 20 percent of the market, he said.
Doctors are allowed to use devices for purposes that don’t have formal FDA approval. The agency warned them and device makers about the risks after receiving reports of hundreds of adverse events. An FDA analysis found that more than 90 percent of biliary stent injuries and malfunctions from 2001 to 2006 occurred when the devices were used in off-label procedures.
The case is U.S. ex rel. Colquitt v. Abbott Laboratories f/k/a Guidant Corp., 06-cv-01769, U.S. District Court, Northern District of Texas (Dallas).
MIB Abstract ID Number: 22306
Readmissions Dip 47% When Some Patients Self-administer IV Antibiotics
Link to full article
Lead Author: Alexandra Wilson Pecci
HealthLeadersMedia, 2016-04-01
Uninsured patients requiring prolonged courses of treatment with intravenous antibiotics can be trained to treat themselves at home and achieve outcomes comparable to patients who receive treatment in traditional settings, data shows.
Teaching uninsured patients how to self-administer IV antibiotics for outpatient parenteral antimicrobial therapy (OPAT) has paid off for Parkland Hospital, a safety-net hospital serving Dallas County, Texas.
The program has resulted in similar or better clinical outcomes than healthcare provider-administered OPAT and 47% lower 30-day readmission rates over a four-year period, according to a recent study published by PLOS.
Lead study author Kavita Bhavan, MD, medical director of the Infectious Diseases OPAT Clinic at Parkland, and assistant professor of internal medicine at the University of Texas Southwestern Medical Center, explains the program, in an interview with HealthLeaders. This is the first of two parts. The transcript of her remarks has been lightly edited.
About the program:
The program is for uninsured patients to self-administer antibiotics at home as an alternative to remaining in the hospital or a traditional healthcare setting to complete their therapy. Patients who receive OPAT services are typically those who have been diagnosed in the hospital with an infection that requires a prolonged course of antibiotics.
This is done for more invasive infections, whether it’s osteomyelitis (an infection of the bone) or endocarditis, a heart valve infection, for example.
OPAT has been around since the late 1970s, was initially shown to work in pediatric populations, and then in adult populations. We started this program in 2009. I’m proud to say that Parkland is the first to publish outcomes of doing this kind of model. We don’t know who else is doing something similar to this.
On why Parkland started the program:
We started the OPAT program because we recognized that patients with infections who require long-term antibiotics typically receive concentrated diagnostics and therapeutic services.
The first couple of days is when we’re really busy trying to figure out what’s wrong with the [patients], trying to figure out a diagnosis, getting a treatment plan going—there’s a lot of stuff happening. But once they’re stable—simply because they have no other place to go—safety-net hospitals would simply just absorb that and have them stay in the hospital or discharge them to another setting to receive care, but not home, necessarily.
We talk about healthcare disparities in this country, and see that the patients who are insured have the option to be discharged early to home or to a lower-cost nursing facility to complete their therapy. But unfunded patients don’t typically receive these options and they usually remain in the hospital.
On improving resource utilization:
The United States leads all other developed countries in healthcare expenditures. I think the data says in 2013 we spent almost $3 trillion—that’s almost the entire GDP of France. And yet with all that we spend we don’t necessarily do well with things like resource utilization.
Safety-net hospitals like Parkland are charged with taking care of those who are uninsured. We have a large population of Medicaid and uninsured patients, for example. We find that our emergency room gets full fast, and our hospital gets full fast.
MIB Abstract ID Number: 22302
Obama Seeks to Expand Opioid Addiction Treatment
Link to full article
Lead Author: Brenda Goodman
Medscape Medical News, 2016-03-30
President Barack Obama traveled to Atlanta on Tuesday to shine a light on the nation’s opioid abuse epidemic, which continues to get worse.
More than 28,000 Americans accidentally overdosed on opioids in 2014, according to the National Center for Health Statistics. About half of those were prescription painkiller overdoses, officials said at the summit.
“When you look at the staggering statistics in terms of lives lost, productivity impacted, cost to communities, costs to families, it has to be something that has to be right up there at the top of our radar screen,” Obama told a town hall meeting at the National Rx Drug Abuse and Heroin Summit.
More people now die of narcotic drug overdoses than die in car accidents each year, Obama said.
Roughly 8 million Americans over the age of 12 need treatment for illicit drug use, according to the Office of National Drug Control Policy.
Meanwhile, 4 out of 5 addicts, 80%, can’t get treatment, even if they want it. That’s because there aren’t enough doctors who know how to treat substance abuse. The treatment programs that do exist have long waiting lists, according to speakers at the summit.
Along with the president’s appearance Tuesday, the White House announced a package of initiatives aimed at turning the tide on opioid addiction in the U.S.
Those included a new proposed rule from the Centers for Medicare & Medicaid Services that would raise the cap on the number of patients doctors can treat with buprenorphine, a controlled substance that helps wean addicts off the more potent drugs they’re abusing. That will allow more people to get this medication, which has been shown to help people recover from addiction.
There’s also more money -- $94 million -- coming for community health centers, and $11 million in new grants for communities that want to expand medication-assisted treatment programs.
That’s just a drop in the bucket compared to the $1.1 billion Obama has proposed “to help every American with an opioid-use disorder who wants treatment get the help they need,” according to a White House press release. Congress still has to approve that money.
Leana Wen, MD, Baltimore’s commissioner of health, drew cheers from the crowd of 2,000 people gathered to hear Obama speak.
She recounted a personal experience with a patient she'd gotten to know when she was working in a hospital ER. The woman, she said, was a competitive swimmer in her twenties. She’d started taking opioid pain medications to treat a back injury, became addicted to them, and switched to heroin. She came to the ER about once a week, Wen said.
“It’s one of the worst realizations for a doctor, it’s one of the most humbling things, is to know that you can’t help them,” Wen said.
The doctors would resuscitate the woman, and she would ask for treatment for her addiction. But they couldn’t get her into a treatment program. Her patient, she said, eventually overdosed and died.
“We would never say to someone who’s had a heart attack, ‘Go home. If you’re still alive in 3 months, come back, and we’ll get you treatment,’” she said, to enthusiastic applause. “We’re treating addiction different than any other disease.”
Wen issued a standing order in Baltimore so that anyone who takes a short amount of training can get a prescription for naloxone, or Narcan, a drug that can reverse an overdose.
“That’s what a solution looks like,” said the town hall moderator, CNN's Sanjay Gupta, MD.
A culture of overprescribing and overmedicating is at the heart of the opioid epidemic, both Obama and Wen said.
“We live in a society where we medicate a lot of problems and where we self-medicate a lot of problems,” the president said.
Gupta told the audience that Americans take 80% of the world’s pain medications. “We don’t have 80% of the world’s pain, I think,” he said.
Wen said she knows doctors aren’t trying to harm their patients when they prescribe pain medications.
“I know that doctors are trying to do the right thing. We’re not trying to get our patients addicted to medications,” she said.
But she said doctors are writing 30-day prescriptions for pain that may last a few days.
“This is the culture of excess that has to change,” she said.
SOURCES:
National Rx Drug Abuse and Heroin Summit, March 29, 2016, Atlanta.
Whitehouse.gov.
CMS.gov.
MIB Abstract ID Number: 22305
FDA clears robotic system for use in peripheral vascular interventions
Link to full article
Lead Author: [none given]
Healio Cardiac/Vascular Intervention, 2016-03-30
Meeting News Coverage - The FDA has cleared the CorPath System for use during peripheral vascular interventional procedures, according to a press release issued by Corindus Vascular Robotics, Inc.
The new 510(k) clearance for peripheral intervention was based on results of the RAPID study, which evaluated the feasibility of the CorPath System to deliver guidewires and balloons to blockages in non-coronary arteries. Researchers at Medical University Graz in Austria enrolled 20 patients with symptomatic disease, including the presence of critical limb ischemia or lifestyle-limiting claudication requiring intervention in iliac and/or superficial femoral arteries, according to information on ClinicalTrials.gov. In this study, use of the CorPath System was associated with 100% device and clinical success, according to the release.
“For the past two years, I have been successfully treating my coronary patients with robotic precision while protecting my staff and me from the hazards of radiation exposure in the cath lab,” Ehtisham Mahmud, MD, chief of cardiovascular medicine, director of Sulpizio Cardiovascular Center-Medicine and director of interventional cardiology at UC San Diego Health System, stated in the release. “The ability to expand robotic precision to treat my peripheral disease patients is an important addition; I am looking forward to continued work with Corindus to optimize robotic therapy for peripheral procedures.”
This marks the third FDA clearance for the CorPath System. The initial clearance was for use during PCI and the second clearance was for use for radial PCI.
Disclosure: Mahmud has served on the advisory board of and received clinical trial support from Corindus.
MIB Abstract ID Number: 22304
Readmissions Dip 47% When Some Patients Self-administer IV Antibiotics
Link to full article
Lead Author: Alexandra Wilson Pecci
HealthLeadersMedia, 2016-04-01
Uninsured patients requiring prolonged courses of treatment with intravenous antibiotics can be trained to treat themselves at home and achieve outcomes comparable to patients who receive treatment in traditional settings, data shows.
Teaching uninsured patients how to self-administer IV antibiotics for outpatient parenteral antimicrobial therapy (OPAT) has paid off for Parkland Hospital, a safety-net hospital serving Dallas County, Texas.
The program has resulted in similar or better clinical outcomes than healthcare provider-administered OPAT and 47% lower 30-day readmission rates over a four-year period, according to a recent study published by PLOS.
Lead study author Kavita Bhavan, MD, medical director of the Infectious Diseases OPAT Clinic at Parkland, and assistant professor of internal medicine at the University of Texas Southwestern Medical Center, explains the program, in an interview with HealthLeaders. This is the first of two parts. The transcript of her remarks has been lightly edited.
About the program:
The program is for uninsured patients to self-administer antibiotics at home as an alternative to remaining in the hospital or a traditional healthcare setting to complete their therapy. Patients who receive OPAT services are typically those who have been diagnosed in the hospital with an infection that requires a prolonged course of antibiotics.
This is done for more invasive infections, whether it’s osteomyelitis (an infection of the bone) or endocarditis, a heart valve infection, for example.
OPAT has been around since the late 1970s, was initially shown to work in pediatric populations, and then in adult populations. We started this program in 2009. I’m proud to say that Parkland is the first to publish outcomes of doing this kind of model. We don’t know who else is doing something similar to this.
On why Parkland started the program:
We started the OPAT program because we recognized that patients with infections who require long-term antibiotics typically receive concentrated diagnostics and therapeutic services.
The first couple of days is when we’re really busy trying to figure out what’s wrong with the [patients], trying to figure out a diagnosis, getting a treatment plan going—there’s a lot of stuff happening. But once they’re stable—simply because they have no other place to go—safety-net hospitals would simply just absorb that and have them stay in the hospital or discharge them to another setting to receive care, but not home, necessarily.
We talk about healthcare disparities in this country, and see that the patients who are insured have the option to be discharged early to home or to a lower-cost nursing facility to complete their therapy. But unfunded patients don’t typically receive these options and they usually remain in the hospital.
On improving resource utilization:
The United States leads all other developed countries in healthcare expenditures. I think the data says in 2013 we spent almost $3 trillion—that’s almost the entire GDP of France. And yet with all that we spend we don’t necessarily do well with things like resource utilization.
Safety-net hospitals like Parkland are charged with taking care of those who are uninsured. We have a large population of Medicaid and uninsured patients, for example. We find that our emergency room gets full fast, and our hospital gets full fast.
MIB Abstract ID Number: 22302
Obama Seeks to Expand Opioid Addiction Treatment
Link to full article
Lead Author: Brenda Goodman
Medscape Medical News, 2016-03-30
President Barack Obama traveled to Atlanta on Tuesday to shine a light on the nation’s opioid abuse epidemic, which continues to get worse.
More than 28,000 Americans accidentally overdosed on opioids in 2014, according to the National Center for Health Statistics. About half of those were prescription painkiller overdoses, officials said at the summit.
“When you look at the staggering statistics in terms of lives lost, productivity impacted, cost to communities, costs to families, it has to be something that has to be right up there at the top of our radar screen,” Obama told a town hall meeting at the National Rx Drug Abuse and Heroin Summit.
More people now die of narcotic drug overdoses than die in car accidents each year, Obama said.
Roughly 8 million Americans over the age of 12 need treatment for illicit drug use, according to the Office of National Drug Control Policy.
Meanwhile, 4 out of 5 addicts, 80%, can’t get treatment, even if they want it. That’s because there aren’t enough doctors who know how to treat substance abuse. The treatment programs that do exist have long waiting lists, according to speakers at the summit.
Along with the president’s appearance Tuesday, the White House announced a package of initiatives aimed at turning the tide on opioid addiction in the U.S.
Those included a new proposed rule from the Centers for Medicare & Medicaid Services that would raise the cap on the number of patients doctors can treat with buprenorphine, a controlled substance that helps wean addicts off the more potent drugs they’re abusing. That will allow more people to get this medication, which has been shown to help people recover from addiction.
There’s also more money -- $94 million -- coming for community health centers, and $11 million in new grants for communities that want to expand medication-assisted treatment programs.
That’s just a drop in the bucket compared to the $1.1 billion Obama has proposed “to help every American with an opioid-use disorder who wants treatment get the help they need,” according to a White House press release. Congress still has to approve that money.
Leana Wen, MD, Baltimore’s commissioner of health, drew cheers from the crowd of 2,000 people gathered to hear Obama speak.
She recounted a personal experience with a patient she'd gotten to know when she was working in a hospital ER. The woman, she said, was a competitive swimmer in her twenties. She’d started taking opioid pain medications to treat a back injury, became addicted to them, and switched to heroin. She came to the ER about once a week, Wen said.
“It’s one of the worst realizations for a doctor, it’s one of the most humbling things, is to know that you can’t help them,” Wen said.
The doctors would resuscitate the woman, and she would ask for treatment for her addiction. But they couldn’t get her into a treatment program. Her patient, she said, eventually overdosed and died.
“We would never say to someone who’s had a heart attack, ‘Go home. If you’re still alive in 3 months, come back, and we’ll get you treatment,’” she said, to enthusiastic applause. “We’re treating addiction different than any other disease.”
Wen issued a standing order in Baltimore so that anyone who takes a short amount of training can get a prescription for naloxone, or Narcan, a drug that can reverse an overdose.
“That’s what a solution looks like,” said the town hall moderator, CNN's Sanjay Gupta, MD.
A culture of overprescribing and overmedicating is at the heart of the opioid epidemic, both Obama and Wen said.
“We live in a society where we medicate a lot of problems and where we self-medicate a lot of problems,” the president said.
Gupta told the audience that Americans take 80% of the world’s pain medications. “We don’t have 80% of the world’s pain, I think,” he said.
Wen said she knows doctors aren’t trying to harm their patients when they prescribe pain medications.
“I know that doctors are trying to do the right thing. We’re not trying to get our patients addicted to medications,” she said.
But she said doctors are writing 30-day prescriptions for pain that may last a few days.
“This is the culture of excess that has to change,” she said.
SOURCES:
National Rx Drug Abuse and Heroin Summit, March 29, 2016, Atlanta.
Whitehouse.gov.
CMS.gov.
MIB Abstract ID Number: 22305
