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CEO founder and four other top administrators were discovered guilty on Thursday in a plan including fixes and kickbacks to doctors who recommended a lot of a fentanyl splash to patients who didn’t require the painkiller.
Following 15 days of considerations, a jury in Boston administrative court achieved a first-since forever conviction of a medication organization CEO in the central government’s battle to battle the narcotic emergency, finding the Arizona-based organization’s originator and previous administrator John Kapoor liable of racketeering intrigue charges.
Additionally discovered liable were: Richard M. Simon, the organization’s previous national chief of offers; Sunrise Lee and Joseph A. Rowan, both onetime territorial deals executives; and previous Vice President of Managed Markets, Michael J. Gurry.
Racketeering charges convey a most extreme punishment of 20 years in jail.
The milestone conviction in the U.S. Area Court for the District of Massachusetts – in which the Justice Department previously made prosecutions in 2016 – marks a triumph on the legitimate front in the administration’s endeavors to battle the rising number of narcotic overdoses. Kapoor’s 2017 capture went ahead that day that President Donald Trump proclaimed the pandemic an open crisis.
The case fixated on a fentanyl-based agony medicine called Subsys, an amazing, exceedingly addictive and conceivably risky opiate that is expected to treat patients with malignant growth experiencing extraordinary torment.
Government investigators contended that specialists somewhere in the range of 2012 and 2015 gave patients extensive quantities of Subsys solutions – including to non-malignant growth patients – in return for kickbacks and influences from the Insys officials. A portion of the specialists, as of now sentenced for wrongdoings the states where they rehearsed, affirmed against the Insys officials amid preliminary.
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The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.
“In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible. In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone. The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most – friends and families of opioid users, as well as first responders and community-based organizations. We’re taking many steps to improve availability of naloxone products, and we’re committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.”
Medication Assisted Treatment ( MAT ) gets a big expansion in California
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In an effort to address the opioid epidemic throughout the state, the California Department of Health Care Services (DHCS) is implementing the California Medication Assisted Treatment (MAT) Expansion Project. The California MAT Expansion Project aims to increase access to MAT, reduce unmet treatment need, and reduce opioid overdose related deaths through the provision of prevention, treatment, and recovery activities.
Visit the SAMSHA / State of California website here: http://choosemat.org/
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The rating system would drive improvement by setting a standard in the industry and increasing transparency and accountability. Five states are partnering with national nonprofit Shatterproof to create the Rating System for Addiction Treatment Programs — a system that would essentially do for addiction treatment centers what TripAdvisor does for hotels. The system, according to the organization, will deliver “trustworthy, standardized information about the levels and quality of care offered at all types of treatment centers.”
The first three states are Louisiana, Massachusetts and New York, and they’ll be joined by two more, which Shatterproof says it will announce in the next few weeks.
SETTING A STANDARD
Creating such a system “will drive improvement among treatment programs by increasing accountability and transparency, and it will supply states and health-care payers with the information necessary to reward high-quality care,” according to Shatterproof, which Founder and CEO Gary Mendell launched after his son committed suicide over the shame he felt about his own addiction.
Abuse of tobacco, alcohol, illicit drugs and prescription opioids costs more than $740 billion annually by way of crime, lost work productivity and health care, according to the National Institute on Drug Abuse. And according to a survey by the Substance Abuse and Mental Health Services Administration, as many as 90 percent of those who need drug rehab the most don’t receive it.
For those who do receive help, no system exists that makes it easy to choose a quality treatment program.
“The quality of care varies widely among addiction treatment programs, and individuals looking for care can’t identify high-quality programs,” Mendell said in a press release. “It is time a standard be set across all of addiction treatment, and the entire system aligns behind evidence-based care.”
Within the addiction treatment field, many addiction treatment practices are based not on what the evidence and research show best improves patient outcomes, said Samantha Arsenault, director of national treatment quality initiatives at Shatterproof, but on people’s life experiences, their philosophies about addiction or on payment structures versus what is best for the patient.
“One concrete example of that is that we are in the wake of an opioid epidemic and yet 60 percent of the specialty addiction treatment programs in the U.S. don’t offer a single medication to treat opioid use disorder,” she told Government Technology. “That would be like saying, ‘We are in the height of a diabetes crisis and 60 percent of the facilities that treat diabetes don’t offer insulin.’”
And this is why Shatterproof finds it absolutely critical not only to bring transparency for people seeking treatment so they can locate high-quality care, Arsenault added, but also to bring accountability to adhering to those best practices within the industry.
FDA to broaden access to medication-assisted treatment for opioid addiction
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OxyContin maker Purdue Pharma LP is exploring filing for bankruptcy to address potentially significant liabilities from roughly 2,000 lawsuits alleging the drug manufacturer contributed to the deadly opioid crisis sweeping the United States, people familiar with the matter said on Monday.
The potential move shows how Purdue and its wealthy owners, the Sackler family, are under pressure to respond to mounting litigation accusing the drugmaker of misleading doctors and patients about risks associated with prolonged use of its prescription opioids.
Purdue denies the allegations, arguing that the U.S. Food and Drug Administration-approved labels for its opioids carried warnings about the risk of abuse and misuse associated with the pain treatments.
Filing for Chapter 11 protection would halt the lawsuits and allow Purdue to negotiate legal claims with plaintiffs under the supervision of a U.S. bankruptcy judge, the sources said.
Shares of Endo International PLC and Insys Therapeutics Inc, two companies that like Purdue have been named in lawsuits related to the U.S. opioid epidemic, were down more than 12 percent and more than 5 percent, respectively, on Monday morning.
More than 1,600 lawsuits accusing Purdue and other opioid manufacturers of using deceptive practices to push addictive drugs that led to fatal overdoses are consolidated in an Ohio federal court. Purdue has held discussions to resolve the litigation with plaintiffs’ lawyers, who have often compared the cases to widespread lawsuits against the tobacco industry that resulted in a $246 billion settlement in 1998.
BANKRUPTCY FILING NOT CERTAIN
A Purdue bankruptcy filing is not certain, the sources said. The Stamford, Connecticut-based company has not made any final decisions and could instead continue fighting the lawsuits, they said.
“As a privately-held company, it has been Purdue Pharma’s longstanding policy not to comment on our financial or legal strategy,” Purdue said in a statement.
“We are, however, committed to ensuring that our business remains strong and sustainable. We have ample liquidity and remain committed to meeting our obligations to the patients who benefit from our medicines, our suppliers and other business partners.”
Read the complete article at Reuters.com
Kentucky sues Walgreens for its alleged role in the opioid crisis
The more opioids doctors prescribe, the more money they make
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