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Categories: Opiates

Attorneys general from over three dozen states are urging health insurers to review their coverage policies for pain treatment to help reduce the role that prescription painkillers continue to play in the deadly opioid epidemic. More than 40 Americans die each day from overdoses involving…

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Millions more are at risk of developing a dependency – in 2014 as many as 10 million people reported using opioids for non-medical reasons.
  • The economic toll of the epidemic is costing the U.S. economy an estimated $78.5 billion annually.
  • State and local governments alone spend nearly 8 billion dollars a year on criminal justice costs related to opioid abuse.
  • According to the CDC, opioid overdoses kill 91 Americans every single day, and more than half of those deaths involve prescription opioids.
  • The AGs emphasize how the “unnecessary over-prescription of opioid painkillers” significantly contributes to the problem:

    • Although the amount of pain reported by Americans has remained steady since 1999, prescriptions for opioid painkillers have nearly quadrupled over the same period.
    • The four-fold increase in prescriptions perfectly matches the four-fold increase in opioid overdose deaths during the same period.
    • A “dramatic increase in supply” has made it easy to obtain prescription opioids without having to resort to the black market.
    • Over 50 percent of people who misuse opioids report that they obtained them free from a friend or relative, while another 22 percent misused drugs that they obtained directly from a doctor.

    Illegal opioids like heroin remain a serious problem that must be addressed, the AGs say, but the role played by prescription opioids cannot be ignored.

    “Incentivizing” opioid alternatives

    “All else being equal,” the AG letter says, “providers will often favor those treatment options that are most likely to be compensated, either by the government, an insurance provider, or a patient paying out-of-pocket. Insurance companies thus are in a position to make a very positive impact in the way that providers treat patients with chronic pain.

    “When patients seek treatment for any of the myriad conditions that cause chronic pain, doctors should be encouraged to explore and prescribe effective non-opioid alternatives, ranging from non-opioid medications (such as NSAIDs) to physical therapy, acupuncture, massage, and chiropractic care. Insurance companies can play an important role in reducing opioid prescriptions and making it easier for patients to access other forms of pain management treatment.

    Status quo unacceptable

    “In the near future, working in conjunction with other institutional stakeholders (such as State Insurance Commissioners), we hope to initiate a dialogue concerning your members’ incentive structures in an effort to identify those practices that are conducive to these efforts and those that are not. We hope that this process will highlight problematic policies and spur increased use of non-opioid pain management techniques. The status quo, in which there may be financial incentives to prescribe opioids for pain which they are ill-suited to treat, is unacceptable. We ask that you quickly initiate additional efforts so that you can play an important role in stopping further deaths,” the AGs said.

    Here at Novus, we are 100 percent behind any intelligent effort that can help reduce the proliferation of prescription opioids. Other, less risky treatment options do exist, and they should be encouraged.

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    Categories: Opiates

    Speaking to a National Press Club Luncheon in Washington, D.C., recently, FDA Commissioner Dr. Scott Gottlieb said, "We've watched over a 10 or 15 year period this epidemic grow in proportion. And even as we've tried to take measures to intervene in various ways, the epidemic was always 5 steps…

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    withdraw Opana ER from the market, based on a new analysis of the risks associated with the drug’s illicit use. Opana ER, an extended release, tamper- or abuse-resistant formulation of the opioid oxymorphone hydrochloride, drove one the deadliest outbreaks of HIV/AIDS and Hepatitis C in a decade, along with overdose deaths, among addicts in Indiana.

    Studies showed that the formulation, when abused and injected, released an excipient that caused autoimmune phenomena that contributed to the alarming spread of disease associated with its abuse. The drug was also more prone to injection than other abuse-resistant formulas in use today.

    “I recently have seen media reports stating that Endo is participating in a re-launch of the old version of Opana ER,” Dr. Gottlieb said. “This is the version of that drug that Endo had previously withdrawn from the market when it launched its reformulated version of Opana – because that older version didn’t purport to have abuse deterrent features.”

    The Commissioner said he wouldn’t speak about regulatory intentions regarding specific drugs, but that the agency will “address oxymorphone products more generally.” He said a study already commissioned is looking at the possibility that oxymorphone “is more likely to be abused than other Schedule II opioids, including through illicit routes of administration such as snorting and injection.”

    “I’m announcing that study for the first time. If the scientific results of this study demonstrate that this ingredient has qualities that make it more likely to be abused, FDA would consider taking regulatory actions that could limit patient exposure to oxymorphone.”

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    Categories: Legal, Opiates

    Former White House 'Drug Czar' says more is needed to "make a significant impact on the trajectory of the worst health crisis of our time." After saying for months he would declare the opioid crisis a national emergency, which his own special commission has urged since July, President Donald J.…

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    Categories: Legal, Opiates

    A group of public health officials and doctors have filed a "Citizen Petition" with the Food and Drug Administration (FDA) asking the agency to remove ultra-high dosage unit (UHDU) opioid painkillers from the market. The petition specifically targets oral and transmucosal painkillers providing…

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    A study of nearly 90,000 pediatric patients, ages 13 to 21 years, has found that new, persistent opioid use following surgery “may represent a significant pathway to nonmedical opioid use among adolescents.” In fact, compared to a control group of non-drug-using, non-operative…

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    Endo Pharmaceuticals has agreed to pull Opana ER from the U.S. market, several weeks after being asked to do so by the FDA. The abuse-deterrent extended-release formulation of the opioid painkiller oxymorphone hydrochloride has been tagged by an Agency safety committee as too easily…

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    recently reported, the FDA asked Endo to remove Opana ER from the market in June, based on a review of “postmarketing data” which revealed that addicts were easily overcoming the abuse-deterrent formulation and injecting the drug.

    Needle-sharing – even among members of the same family – has been the source of the spread of HIV and Hep-C infections. And Opana ER abuse has also been found to be the source of ‘thrombotic microangiopathy’ among abusers. This rare but serious blood clotting disorder damages the tiny blood vessels in the body’s vital organs, most commonly the kidney and brain, and can be fatal.

    A single Opana ER pill contains an average 12-hour dose of oxymorphone. The drug is 10 times as potent as morphine, and is intended only for serious pain control.

    However, when abusers crush, dissolve and inject it, that huge 12-hour dose of oxymorphone is suddenly an overdose risk for any but seasoned addicts.

    Of course, needle sharing by infected users raises the public health threat to the level of a disaster.

    Not the first time

    According to the FDA statement, “this is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.”

    Well, that statement is not 100% accurate. Back in 1979, the agency asked Endo Pharmaceuticals to remove its oxymorphone painkiller pills, called Numorphan, from the market.

    That less-than-timely request followed a vicious epidemic of overdoses, ruined lives and deaths directly caused by diverted Numorphan pills, and which went on for 20 years – from 1959 to 1979 – before anyone did anything about it.

    Neither the FDA nor Endo Pharmaceuticals admitted publicly they had anything to do with the epidemic or why Numorphan pills were suddenly pulled from the market.

    Although the Numorphan pills were withdrawn, the Numorphan name remained on several injectable and rectal oxymorphone medications from Endo.

    The new epidemic isn’t news either

    As we reported two years ago, Opana ER was a favorite of opioid addicts centered around Austin, IN, and elsewhere for years.

    One has to ask why the FDA sat idle for at least two years while the epidemic spread, claiming over 120 victims in the tiny city of Austin, IN, pop. 4,200 – and beyond. Or why the agency was paralyzed for 20 years while Numorphan ravaged the opioid addiction underworld through the ‘60s and ‘70s.

    One also has to wonder why, in 2006, the FDA “reapproved” Endo’s Numorphan oxymorphone pills under a new trade name, Opana. And then in 2011, the agency approved the extended release Opana ER.

    Bottom line, this is not the first time the FDA has asked for a market removal “due to the public health consequences of abuse.” Today’s Opana ER is essentially the same product, albeit extended release, that the FDA had Endo remove from the market 38 years ago because of abuse.

    In its favor, Endo says it will coordinate the orderly removal of Opana ER from the market with the FDA, so that patients have enough time to seek alternative treatment options.

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    Categories: Health, Opiates

    If you or someone you care for is being treated for anxiety, depression or some other mental health disorder, and are taking opioids to treat a painful condition, it would be wise to seek alternative pain relief. People with emotional problems who use opioids are more at risk for dependence and…

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    (Novus writes inspirational stories of people in the news who have overcome addiction. This is not to infer that these people are connected to Novus Medical Detox Center but simply to provide hope and encouragement to those fighting addiction.) Early in his career with the San Diego Chargers of…

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    (Novus writes inspirational stories of people in the news who have overcome addiction. This is not to infer that these people are connected to Novus Medical Detox Center but simply to provide hope and encouragement to those fighting addiction.)

    Early in his career with the San Diego Chargers of the National Football League (NFL), Shane Olivea was pegged as one of the players to watch, one of the potential all-time greats.

    Considered an early draft “steal” by the Chargers in 2004, Olivea rapidly exceeded his humble draft status by making several all-rookie teams.

    By 2006, his third season with the Chargers, Olivea had signed a 6-year, $20-million contract extension with a $7.5 million signing bonus.

    But late in the 2007 season, Olivea lost his starting position at right tackle, and was inexplicably benched. Soon the 6 foot, 5-inch, 325-pounder ballooned to nearly 400 pounds. And before the real story was made public, he was released by the Chargers in February, 2008 – the NFL term for contract cancellation – and vanished from the Charger’s bench.

    Unknown to much of the press and public, by April, 2008, he was at the Betty Ford recovery center in Rancho Mirage, CA.

    When he finally agreed to talk to reporters, they were shocked to hear that Olivea had actually asked the Chargers for his release so he could enter treatment for a serious opioid painkiller addiction!

    Outstanding college record

    Shane Olivea was born on October 7, 1981, and was raised in Cedarhurst, NY, a small town – a village actually – on the South Shore of Long Island just across the bay from JFK International.

    Before the big teenager was drafted by the Chargers, Olivea had demonstrated his outstanding ability at right tackle with the Ohio State University (OSU) national champion Buckeyes. He had originally committed to Georgia Tech, but changes in the coaching staff there prompted him to switch his commitment to Ohio State.

    Olivea was a Buckeyes star from 2000 to 2003 – so good, in fact, that a decade later in 2013, OSU-Buckeye alumni and fans voted him onto their “All-Decade Team 2000-2009.” The Buckeyes newsletter said Olivea played an integral role in OSU’s 2002 National Championship.
    “Along with being a part of that great Buckeye team, Olivea also twice earned second-team All-Big Ten honors,” the journal said.

    Olivea left OSU after his senior season in 2003 without having earned a degree. But he says his goals were clear and had been since childhood: “Play a decade or so in the NFL, get rich, and then go on about his life,” he told Bill Rabinowitz at the Columbus Dispatch recently.

    “Everybody can tell you what to do to get to your dream. But when you actually achieve the dream that you have when you’re 5, 6 or 7 years old – to be one of the rare few in the NFL – no one tells you what to do,” Olivea said.

    125 Vicodins a day

    But childhood dreams don’t tell you about the pain suffered routinely by NFL players. Or about the dangers of opioid painkillers that are so widely used – and abused.

    Olivea said that all through college and his rookie NFL year he didn’t take any painkillers. But by the end of the first NFL season he “was so sore and exhausted that he barely left his bed for a week.”

    Then one night, a teammate had a friend who offered him Olivea a Vicodin. And almost immediately, he says, he was hooked.

    “There wasn’t one day in the NFL I wasn’t high on a pill after my rookie year,” Olivea said. “At my height on Vicodin, I would take 125 a day. It got to the point I would take a pile of 15 Vicodin and would have to take them with chocolate milk. If I did it with water or Gatorade, I’d throw it up.”

    Olivea told the Dispatch he didn’t get the pills from the Chargers doctors. He “had his own sources” including a taxi driver in Mexico, which is next door to San Diego, who for $100 went to a Tijuana “pharmacy” for him.

    “You could buy anything you want if you had cash,” Olivea said. “I’d go buy a couple hundred Vicodin, or by then I’d progressed to Oxycontin. How I functioned and played is head-scratching,” he said.

    Withdrew from teammates

    Under the opioids, he withdrew from teammates and his relationship with coaches and management soured.

    Eventually, his family noticed the personality changes.

    “That was never the way our relationship was,” his mother Jean said. “I knew something was not right. You can’t just ignore it.”

    Shane’s mom organized an intervention at his home – mostly friends and family, and Chargers teammate Roman Oben, a former Cleveland Brown player who’d become a mentor for Shane on the Chargers. Oben told Shane he loved him as a brother and a teammate, and that Shane “needed to get as much help as possible.”

    Rather than put off by the intervention, Olivea says he was relieved. He knew he had a problem and he’d been unable to ask for help.

    Too full of pride

    “I was too full of pride,” Olivea said. “I always said that my pride got me to the NFL, and it got me to rehab. I’m an offensive lineman. You don’t show pain. We’re the tough guys on the team. We sort of suffer in silence. I wanted to reach out, that I needed help. I wanted to stop. I went through withdrawal, physical withdrawal. But I didn’t know how to ask for help. It almost killed me.”

    He went to rehab that same day. And he says that doctors who’d been at the center for 20 years repeated the blood tests because they couldn’t believe the results.

    “They both looked at me and said we’ve never seen anybody living with that amount of opioids in you. You’re literally a walking miracle. That was a punch to the gut.”

    Olivea spent 89 days at the Betty Ford Center. “I’m like, ‘I just took pills. I’m OK. I made it to the NFL. I can do this,'” Olivea said. “It just shows you how strong and how much of a hook those pills have. I didn’t care about my career anymore. I didn’t care about a lot of things. I didn’t care about myself, unfortunately. You go there and you do a lot of soul-searching.”

    A new beginning

    Rehab may have saved his life but not his NFL career. Released by the Chargers, Olivea signed with the New York Giants while in rehab. But he hurt his back in training and they let him go too. It was clear that his NFL career was over.

    But Olivea realized that he could go back to OSU and complete his degree and start a new life. He re-enrolled in the summer of 2015, took 11 courses to finish his degree in sports industry, and late last year was presented with his diploma.

    He says he’s looking for a job as a coach. “I feel I have an ability to connect with kids,” he told Rabinowitz at the Dispatch. “I’m young at heart. Being around young people keeps you young. I feel there’s such a need to teach some of these kids how to properly play and teach technique.”

    Shane Olivea is thrilled with his recovery, as are his mom and his family. The last report we saw, he’s got a few job leads for coaching, too.

    As for the risks of drugs: “If you got it, you can spot it. I can spot an addict in a public setting. I know the behavior. I know the tendencies. I know what he’s going to do. I’ll be able to notice somebody going down that slippery path and maybe catch them.”

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    Physicians from lower-ranked medical schools prescribe nearly three times as many opioids per year as graduates from top-tier institutions, says a new study by two Princeton University economics professors. Clinical use of prescription opioids has quadrupled since 1999, almost exactly…

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    study was published as a working paper for discussion by the National Bureau of Economic Research (NBER), the largest economics research organization in the country.

    Striking relationship

    “Using data on all opioid prescriptions written by physicians from 2006 to 2014, we uncover a striking relationship between opioid prescribing and medical school rank,” wrote the paper’s authors, Janet Currie, PhD, and Molly Schnell, a PhD candidate. “Even within the same specialty and county of practice, physicians who completed their initial training at top medical schools write significantly fewer opioid prescriptions annually than physicians from lower ranked schools.”

    It’s unlikely that these differences in prescribing decisions were due to some sort of differences in the patients seen by doctors from higher- and lower-ranked schools. The study points out that the evidence was the same across geographic regions, across specialties, and even within the same hospitals.

    “The relationship between medical school rank and propensity to prescribe opioids persists even among specialists who attended different medical schools but practice in the exact same hospital or clinic-where patients can be assumed to be relatively homogenous in their need for opioids,” the study said.

    This additional evidence, they said, suggests “a causal effect of education rather than patient selection across physicians or physician selection across medical schools. Altering physician education may therefore be a useful policy tool in fighting the current epidemic.”

    Overall, physicians from Harvard wrote fewer than 100 opioid prescriptions a year, compared to physicians from the lowest-ranked schools who wrote 300 a year. But the most striking differences were found among general practitioners, who accounted for nearly half of all opioids prescribed during the study period.

    Harvard grad GPs wrote an average of 180 opioid prescriptions a year, while GPs from the lowest-ranked schools averaged 550 prescriptions a year.

    Meanwhile at Harvard…

    A year ago, the Obama White House asked medical schools “to sign a pledge” to require students to study new guidelines from the CDC for safe opioid prescribing before they graduate. According to a MedPage Today report, “of the nation’s 170-plus medical schools, 61 signed on.”

    Harvard Med was one of those that refused to make the “pledge” to implement the CDC guidelines, saying that safe opioid prescribing is already part of the curriculum. But a group of Harvard med students said they weren’t satisfied with their education on opioids. So a group of them organized additional training on better opioid prescribing practices and how to more effectively treat addiction using the opioid overdose reversal drug naloxone (trade name Narcan).

    MedPage said their efforts took place “amid a surge in deaths from opioid overdoses, which killed an estimated 28,000 people in the United States in 2014. And at least half of those deaths involved a drug prescribed by a doctor.”

    Take it to the next step

    The 61 schools that accepted the White House’s pledge to implement the CDC guidelines have begun enhancing their opioid training.

    The NBER study’s Molly Schnell told MedPage that if the CDC training turns out to be effective, and if her medical education research gets “sufficient attention,” she and others could start to examine medical education and training “on a more granular level.”

    “One thing we would love is to start working with medical schools to maybe know what they’ve been teaching and see if we can pinpoint which strategies are most effective,” Schnell said.

    Meanwhile, here at Novus we help patients get their lives back from opioid dependence every day. Our development of innovative opioid detox protocols shows we’re on board with improving treatment methodologies. We congratulate those enterprising, proactive Harvard students, and all the med schools, seeking to find better ways to make a difference.

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    The state of New Hampshire has filed suit against OxyContin manufacturer Purdue Pharma for its alleged role in helping create the opioid epidemic afflicting the nation. New Hampshire, which President Donald Trump recently dubbed a “drug-infested den,” is number two in the country for opioid…

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    sued opioid distributors over its drug crisis, the first such case brought in a tribal court.

    Back in 2007, Purdue was fined $634 million by the federal government for charges related to its “misbranding” of OxyContin. At that time, it was the largest fine ever levied against an American corporation. Purdue also reached a $19.5 million settlement with 26 states and the District of Columbia. New Hampshire wasn’t among those states that benefitted from the Purdue settlement.

    Most recently, in 2015, the drugmaker agreed to pay $24 million to resolve a lawsuit by the state of Kentucky.

    “To defeat the epidemic, we must stop creating new users, and part of that is making sure these highly addictive and dangerous drugs are marketed truthfully and without deception and in such a way as not to minimize addiction risks or overstate benefits to patients,” said Ann Rice, the state’s Deputy Attorney General. “New Hampshire continues to experience a severe opioid epidemic. Last year alone nearly 500 overdose deaths occurred – almost ten times more than in 2000.”

    Purdue’s reply

    Purdue provided a response to the New Hampshire lawsuit in a statement to the media:

    “While we vigorously deny the allegations, we share New Hampshire officials’ concerns about the opioid crisis, and we are committed to working collaboratively to find solutions. OxyContin accounts for less than 2 percent of the opioid analgesic prescription market nationally, but we are an industry leader in the development of abuse-deterrent technology, advocating for the use of prescription drug monitoring programs and supporting access to Naloxone — all important components for combating the opioid crisis.”

    The rash of litigation related to the opioid epidemic may not be over. According to a June report, some 20 state attorneys general have announced their own investigations into the roles played by pharmaceutical companies involved in opioid manufacturing and distribution.

    If you or someone you care for is experiencing dependence or addiction to opioids, or any drugs or alcohol, don’t wait until it’s too late. Do something about it now. Call Novus today.

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