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Legislation aims to change opioid labeling

Posted on July 12, 2019 by Pharmaciststeve

Legislation aims to change opioid labeling

https://www.register-herald.com/health/legislation-aims-to-change-opioid-labeling/article_5eb29c8f-866f-5156-ba8b-ba74f3a62f9f.html

Two U.S. Senators introduced a piece of legislation Thursday which would prohibit the Food and Drug Administration (FDA) from allowing opioids to be labeled for intended use of “around-the clock, long-term opioid treatment.”

The FDA Opioid Labeling Accuracy Act, introduced by U.S. Sens. Joe Manchin, D-W.Va., and Mike Braun, R-Ind., would prohibit such labeling until a study can be completed on the long-term usage of opioids.

“In the United States, we consume 80 percent of the world’s opioid production and in 2017, one single year, over 70,000 people died due to drug overdoses,” Manchin said in the release. “These statistics are unacceptable. As one of the hardest hit states, West Virginia has been on the front lines of the opioid epidemic, which is why I have introduced this bill today with Senator Braun to address how the FDA approves opioid prescriptions for treating different types of pain.”

In 2001, the release said the FDA updated opioid labels to indicate use from “moderate to severe pain where use of an opioid painkiller is used for more than a few days” to “management of moderate to severe pain when opioids are needed for an extended period of time.”

With this change, opioids began to be prescribed as a first line of treatment for long-term chronic pain that surpassed the original intended use for cancer pain or short term post-surgical pain and definitively contributing to the heightening of the opioid epidemic.

The FDA Opioid Labeling Accuracy Act would prohibit opioids from being labeled for intended use to treat long-term chronic pain, except for cancer pain, end-of-life care or when a prescriber has determined that all non-opioid treatments are inadequate or inappropriate.  

— Email: wholdren@register-herald.com and follow on Twitter @WendyHoldren

This past Monday, Senator Braun had a “town hall meeting” in Corydon IN.  At one point he was talking about “Medicare for all”.. which apparently he was not in favor of.  I tried to point out to him that what “they” are talking about is “MEDICAID FOR ALL” because it would seem that they are talking about paying for FIRST DOLLAR for everyone’s medical care..  I pointed out that Medicare required premiums, deductibles, co-pays and it was MEDICAID that may have minimal copays … mostly on prescriptions… otherwise the pt has “no skin in the game” …   He went right back to talking about “MEDICARE FOR ALL”

Senator Manchin, in the last Congressional session, proposed a “opiate prescription tax” to get money from group of pts (chronic painers ) to pay for the treatment for another group of pts (substance abusers).

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‘Something we’re not proud of’: Fired deputy Zach Wester arrested in drug planting probe

Posted on July 11, 2019 by Pharmaciststeve


https://www.tallahassee.com/story/news/local/2019/07/10/former-jackson-county-deputy-zach-wester-arrested-drug-planting-probe/1691366001/

Fired Jackson County Deputy Zach Wester was arrested Wednesday on racketeering and numerous other charges for allegedly planting meth and other street drugs on unsuspecting motorists before hauling them off to jail.

Agents with the Florida Department of Law Enforcement, who have been investigating Wester for more than nine months, arrested him in Crawfordville and took him to the Wakulla County Jail, where he is being held without bail. Wester, expected to make his first court appearance on Thursday, invoked his right to remain silent and declined to speak with investigators.

More: Read the arrest warrant for former Jackson County Deputy Zach Wester

An unknown item can be seen in Wester’s left hand around the 4:53 minute mark.An unknown item can be seen in Wester’s left hand around the 4:53 minute mark. (Photo: Special to the Democrat)

He was arrested on 52 counts in all. Aside from the racketeering count, he was charged with a number of other felonies, including official misconduct, false imprisonment, fabricating evidence and possession of a controlled substance. He was also charged with misdemeanor charges of perjury, possession of a controlled substance and possession of drug paraphernalia, FDLE said.

Jackson County Sheriff Lou Roberts, State Attorney William “Bill” Eddins of the 1st Judicial Circuit and Chris Williams, special agent in charge of the FDLE’s Pensacola office, discussed the case in an afternoon news conference. One of Wester’s alleged victims, Teresa Odom, wept as they discussed details of the case.

“I’m overwhelmed,” she said afterward, adding she was proud of one of the FDLE agents who worked with her during the investigation.

‘Something we’re not proud of’

Roberts, who had been silent about the Wester allegations since the Tallahassee Democrat broke the story last year, said Wester’s alleged crimes were “disheartening.” He thanked the community for its patience during the investigation, which got sidetracked after Hurricane Michael hit Oct. 10.

“This is something we’re not proud of,” said Roberts, who plans to retire and not seek re-election next year. “No agency wants to go through this kind of situation and face the embarrassment of the public. This is a very serious matter. We’re supposed to set higher standards, and the allegations that were made in this case will be tried.”

Eddins and Williams offered new details in the case, including a large amount of drugs found in Wester’s vehicle during an internal affairs probe that began last August. But investigators declined to give a possible motive for Wester’s alleged actions.

“You’re never certain of the ways of the heart of man,” Eddins said. “We have some ideas and some theories, and we’ve talked about that a lot. But I do not feel that it would be appropriate to go into it in any detail at this time.”

Williams emphasized that the case was still open, and he asked the public to call FDLE’s Pensacola office if they have any information about Wester.

“A significant investigation has been and is being conducted,” Williams said. “FDLE has assigned a team of 10 special agents and two crime analysts who have logged over 1,400 hours on this case already. And it’s still ongoing today.”

Eddins, who was assigned the case after Glenn Hess, state attorney for the 14th Judicial Circuit recused himself, said he was prepared to go to trial now if Wester demands a speedy trial. And he said he will not allow a plea bargain in the case in part because it involves a public employee. He added that so far, no evidence has been found that any other deputies or other Sheriff’s Office personnel worked in concert with Wester. 

“It’s been my experience in monitoring this investigation that the law enforcement community in Jackson County is honest, professional and they do not condone or support illegal activity,” Eddins said. “I cannot overstate how complete and how well (the Sheriff’s Office) cooperated with us.”

‘His actions put innocent people in jail’

FDLE began its investigation last August at the request of the Sheriff’s Office after whispers of misconduct by Wester began to surface around the courthouse. He was suspended Aug. 1 and fired a month later. During the internal investigation, deputies searching his patrol car found 42 pieces of drug paraphernalia, ten baggies of methamphetamine and five baggies of marijuana concealed in an unmarked and unsecured evidence bag in the trunk.

“The items located within Deputy Wester’s patrol car were not maintained as required of legitimate evidence, items for safe keeping or items for destruction,” the arrest affidavit says. “The multiple items located were consistent with, and similar in appearance to, items believed to have been used to fabricate evidence during (his) traffic stops and arrests.”

THE BACK STORY:

Former Jackson County Deputy Zach Wester has been arrested on numerous charges in connection with an investigation into allegations he planted street drugs like meth on unsuspecting motorists.Former Jackson County Deputy Zach Wester has been arrested on numerous charges in connection with an investigation into allegations he planted street drugs like meth on unsuspecting motorists. (Photo: Wakulla County Sheriff’s Office)

  • More federal lawsuits piling up against deputy accused of planting meth
  • Fired deputy under investigation for planting drugs
  • Campbell reviewing cases brought by Jackson County fired deputy in drug planting probe
  • Prosecutor who sparked Jackson County drug-planting probe resigns as whistleblower
  • Allegations of hanky-panky followed fired Jackson County deputy accused of planting drugs

The investigation found Wester routinely pulled over citizens for alleged minor traffic infractions, planted drugs inside their vehicles and arrested them on fabricated charges. It also found that Wester misused his body camera, sometimes turning it off before drugs were located or turning it on just after they were found.

“There is no question that Wester’s crimes were deliberate and that his actions put innocent people in jail,” Williams said in a news release. “I am proud of the hard work and dedication shown by our agents and analysts on this case to ensure justice is served.”

Christina Pumphrey, a former assistant state attorney in Marianna who helped bring Wester’s alleged misdeeds to light, said she was “incredibly surprised” to learn of his arrest because she didn’t think he’d ever get charged.

The last I read, the Supreme Court has determined that a police office can’t required a person stopped for a traffic stop.. they cannot make a person wait for a “drug dog” and handler to show up to “sniff the car” if the person declines for the officer to search the car. The Supreme Court declared that the detaining of a person was consider a unreasonable SEARCH AND SEIZURE… violation of the 4th Amendment.

I once saw a video before this Supreme Court ruling where the person allowed his car to be “searched by a dog” . little did the police know that the person they have pulled over .. was a trainer of these dogs and he pointed out in the video where the dog was responding to the officer’s signal to react as if there was contraband in the person’s car.

Needless to say that this person, got the charges dropped… what happened to the canine officer… after this case was thrown out… I don’t remember.

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Industry lobbyists – and their MONEY – has gotten to someone

Posted on July 11, 2019 by Pharmaciststeve

White House kills major drug pricing proposal

https://www.axios.com/trump-drug-prices-plan-pharma-ec527a14-0287-492b-937d-a7144c47b734.html

A big part of the Trump administration’s plan to lower drug prices is now dead, White House spokesman Judd Deere confirmed to Axios.

Why it matters: The administration is backing away from an effort to change the way money flows through federal health care programs — one of the most sweeping elements of its drug-pricing blueprint. That’s bad news for pharma, and the move will put pressure on other parts of the administration’s plan, which is also bad news for pharma.

How it works: The now-dead proposal would have overhauled the rebates collected by pharmacy benefit managers — the middlemen between insurance plans and drug companies.

  • They negotiate discounted prices in the form of a rebate, but keep some of those rebates for themselves as profit.
  • Trump’s proposal would have banned that arrangement in Medicare and Medicaid, requiring PBMs to pass the rebates on to patients at the pharmacy counter and find a different way to bring in their own revenues.

What they’re saying: “Based on careful analysis and thorough consideration, the President has decided to withdraw the rebate rule,” Deere said.

  • “The Trump administration is encouraged by continuing bipartisan conversations about legislation to reduce outrageous drug costs imposed on the American people, and President Trump will consider using any and all tools to ensure that prescription drug costs will continue to decline,” he added.

Between the lines: This is very bad news for the pharmaceutical industry, which blames middlemen for high drug prices and vocally supported the proposed rebate overhaul. It’s very good news for insurers and PBMs.

  • Independent critics of the proposal argued it did nothing to require drugmakers to lower their prices and would’ve cost taxpayers hundreds of billions of dollars.

What’s next: This will increase the pressure for the administration to finalize its other major drug-pricing push — which the pharmaceutical industry loathes.

  • That proposal would set Medicare’s prices for certain drugs based on the prices other countries pay. It likely “will be the executive order of choice,” a source close to the administration said.
  • The plan is also controversial among Republicans, who are hesitant to set drug prices.

What we’re watching: The administration is also open to a controversial proposal being discussed in the Senate that would limit how much drug companies can increase their prices within Medicare’s drug benefit.

  • “Driving down outrageous price hikes in prescription drug prices is a priority for the President, and a policy like an inflation cap for Part D drugs is something the Trump administration is seriously considering,” a senior administration official said.

Go deeper: The complicated politics of Trump’s rebate rule

The government just has to open up the VA medication purchasing contract to all community pharmacies.. The get some of the lowest prescription medication prices in the country. Reimburse the pharmacy for the cost of the medication and let the pharmacies determine what the copay is for the pt.  Let the free market determine which community pharmacies prosper or fall by the wayside..  Let the pt decide if they are comfortable – or willing – to pay a higher copay for better, more convenient service or prefers to wait in line and pay a few dollars less out of pocket for their prescriptions.   The PBM’s can still be in the process – back to their original design – a processor of payments… the government will negotiate with them to how much the feds will pay over the cost of the medication – based on the VA contract – to cover their overhead.  Will it happen – NOPE – too easy and too transparent for the insurance/PBM industry.

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Why your local independent pharmacy is going out of business

Posted on July 11, 2019 by Pharmaciststeve

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Amazing what getting paid $725/hr will get some people to say ?

Posted on July 10, 2019 by Pharmaciststeve

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FBI: it can’t arrest its way out of the city’s gang problem

Posted on July 10, 2019 by Pharmaciststeve

FBI says 25 gangs operate in Louisville, and it needs community’s help to stop them

https://www.wdrb.com/news/fbi-says-gangs-operate-in-louisville-and-it-needs-community/article_e40dd104-a34f-11e9-8679-c3c9e201f267.html

Crime Tape

LOUISVILLE, Ky. (WDRB) — There’s been an increase of violence this summer in Louisville, so much so that the FBI has begun investigating cases in the area.

The bureau said it needs the community’s help to stop the violence, and it can’t arrest its way out of the city’s gang problem. FBI Supervisory Special Agent Christopher Farrell said investigators needs people to speak up and help them pull dangerous people off the streets.

“We’re still seeing about the same number of gangs, about 25 gangs, in Louisville,” Farrell said.

The FBI isn’t naming names, saying it doesn’t want to give the gangs notoriety. But it said it’s closely watching gang activity in Louisville.

Each day, there seems to be more shootings. One on Tuesday night in the 2100 block of Greenwood Avenue sent a man to the hospital. LMPD said there are no suspects, and no arrests have been made.

That area of the California neighborhood is particularly active for law enforcement because of gang activity.

“The root of the gang problem is mostly involving narcotics and narcotics trafficking as well as territorial issues between gangs that get in arguments either in the streets or on social media,” Farrell said. 

FBI Supervisory Special Agent Christopher Farrell
FBI Supervisory Special Agent Christopher Farrell

So far this year, through July 8, LMPD said there have been 173 shootings, 52 of which have ended in a fatality.

Last year, there were more shootings, but fewer of them were fatal. 

The violence has four FBI employees working closely with other agencies on violence and gang issues every single day.

“We work collaboratively with LMPD, with DEA, with ATF with the U.S. Attorney’s Office to go after gangs in Louisville and after gang members utilizing local, state and federal charges to go after gang members,” Farrell said. “I think it’s made a big difference in the community. I think you’ve seen a lot of good work done by law enforcement on all levels.”

But the FBI stresses that it needs the community’s help. It’s asking people with tips to remember this number: 1-800-CALL-FBI.

1-800-CALL-FBI

“We are arresting a lot of individuals as a task force with gang members that are carrying firearms or involved in illegal drug activity,” Farrell said.

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“ECO STRAW” kills chronic pain pt

Posted on July 10, 2019 by Pharmaciststeve

Jockey killed by ‘eco-friendly’ metal straw that impaled brain through her eye

A JOCKEY died after an eco-friendly metal drinking straw went through her eye and impaled her brain.

https://www.dailystar.co.uk/news/latest-news/790646/metal-straw-death-elena-struthers-gardner-mason-jar-impaled-brain-poole-dorset

Elena and Mandy Struthers-GardnerTRAGIC: Elena Struthers-Gardner (R) was discovered by her wife Mandy (Pic: FACEBOOK)
Elena Struthers-Gardner, 60, suffered fatal brain injuries in the accident at her home in Broadstone, Poole, on November 22. For injuries due to accident, contact car accident attorneys in Conway, ARThe retired jockey was carrying a mason jar glass with a screw top lid with a 10 inch stainless steel straw. She fell and the straw entered her left eye socket and impaled her brain, the inquest heard.

Her wife Mandy discovered Elena with the straw sticking out of her head and called 999.

Eco-friendly drinking straws are becoming increasingly popular in the UK amid a new push against single use plastics. The injury lawyers located in Framingham can help with injury cases and more.

“Clearly great care should be taken taken when using these metal straws”

Assistant coroner Brendan Allen

Assistant coroner Brendan Allen told the inquest in Bournemouth that “great care” must be taken when using the straws.

Elena was rushed to Southampton General Hospital after suffering the horror injuries.

She was placed on life support which was switched off the following day as doctors could not save her.

The inquest heard that Elena was prone to falling over at random intervals due to a riding accidents when she was 21. 

Elena Struthers-GardnerHEARTBREAK: Elena Struthers-Gardner was uneasy on her feet due to a riding accident (Pic: FACEBOOK)
In a statement read by the corner, Mandy said: “I went to the kitchen door and could see Lena lying on her front at the doorway between the den and the kitchen.“She was making unusual gurgling sounds. Her glass cup was lying on the floor still intact and the straw was still in the jar.“I noticed the straw was sticking into her head. I called 999 and requested an ambulance.

“While I was on the phone, Lena appeared to have stopped breathing.”

Metal strawECO-FRIENDLY: Metal straws are becoming popular amid a backlash to plastics (Pic: GETTY)
 

 

Metal straws DANGEROUS: Elena Struthers-Gardner’s death sparked a warning over the metal straws (Pic: GETTY)
Elena had become alcohol dependent due to the pain from her injury after reductions in her fentanyl medication.She had been drinking half-a-litre of vodka mixed with orange juice a day from the mason jar with the metal straw – which had been a birthday gift.Severe pain from her riding accident came from multiple fractures to her lumbar spine which caused scoliosis.

Her wife said she was prone to falling “like a sack of potatoes” at random – and no alcohol was found in her system at time of death.

Mandy Struthers-GardnerINQUEST: Mandy Struthers-Gardner leaves the coroners court in Bournemouth (Pic: BNPS)
Elena’s brother Robin said the straws can “very easily be lethal” – adding: “Even if they don’t end a life they can be very dangerous.”He said: “I just feel that in the hands of mobility challenged people like Elena, or children, or even able-bodied people losing their footing, these things are so long and very strong.”Assistant corner Allen recorded a conclusion of accidental death – but said there is “insufficient evidence” as to how she fell.

He recommended that metal straws never be fixed in place with a lid, saying: “Clearly great care should be taken taken when using these metal straws.”

 

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Tobacco, now opiates, are they getting ready to take aim at the alcohol industry

Posted on July 10, 2019 by Pharmaciststeve

Oklahoma – like thousands of other municipal plaintiffs — is relying upon an unprecedented use of public nuisance law, J&J says, under which any company that sells a product that can cause injury or death is theoretically liable for money damages regardless of who actually sold or used the product.

J&J calls Oklahoma’s opioid case a ‘legal miscarriage and practical fiasco’ in motion for judgment

https://legalnewsline.com/stories/512714148-j-j-calls-oklahoma-s-opioid-case-a-legal-miscarriage-and-practical-fiasco-in-motion-for-judgment

NORMAN, Okla. (Legal Newsline) – Immediately after Oklahoma closed its case against Johnson & Johnson, the company last week filed a motion seeking judgment in its favor, telling the judge who is overseeing a trial that has lasted five weeks that the State failed to prove J&J caused the state’s opioid crisis.

In a passionately written 124-page brief, J&J told Cleveland County Judge Thad Balkman that the State, his employer, had put him in an “untenable position,” asking the judge to order the company to pay as much as $17 billion to fund a 30-year package of social programs to abate an epidemic of opioid abuse in the state. To rule for the state, J&J said, Judge Balkman “must usurp the legislature and make government policy” on public health and educational questions “for decades to come.”

Such motions for a directed verdict are common at the close of a trial and it seems unlikely Judge Balkman will rule in J&J’s favor, given he denied the company’s pretrial motions to dismiss the case or allow it to proceed before a jury. The filing provides a roadmap of legal arguments for appeal should J&J lose, however, including claims the company is being punished for being on the wrong side of a long-running scientific and academic debate over the appropriate use of opioid painkillers and for associating with physicians and industry groups Oklahoma disagrees with. 

The same themes will likely resurface as opioid manufacturers and distributors fight a wave of similar litigation in state courts around the country and the federal court in Ohio overseeing multidistrict litigation by nearly 2000 cities, counties and Indian tribes.

Oklahoma – like thousands of other municipal plaintiffs — is relying upon an unprecedented use of public nuisance law, J&J says, under which any company that sells a product that can cause injury or death is theoretically liable for money damages regardless of who actually sold or used the product. In repeated barbs at Republican Attorney General Mike Hunter, J&J said Oklahoma’s highest legal officer filed an amicus brief with the Ninth Circuit Court of Appeals opposing such an expansive use of public nuisance law against the energy industry, Oklahoma’s largest employer.

“The State’s hastily revised theories and flagrantly unreliable evidence have saddled this court with a case that is both a legal miscarriage and a practical fiasco,” J&J said. “The State has used this trial – and a slew of illogical, legally defective theories far outside the bounds of Oklahoma precedent – not to `abate’ anything but to find a scapegoat.”

Hunter issued a response on the AG office’s website.

“After over a month of testimony, we have shown why we believe that Johnson & Johnson is the Kingpin behind the opioid crisis that has caused the deaths of thousands of Oklahomans and created a generation of people addicted to opioids in our state,” Hunter said. 

“The evidence is clear that they must be held accountable for the public nuisance they caused and ordered to abate it. They have created this problem and now they want to not only blame the state, but run from the problem. Perhaps most offensive, and what state Mental Health Commissioner Terri White put into perspective so well, is that Johnson & Johnson’s corporate representative, while on the stand, said the company bears zero responsibility for the death and destruction it has caused.”

While J&J makes a number of constitutional arguments based upon the First Amendment and the Due Process Clause, it also accuses Oklahoma of failing to establish the basic elements of a tort lawsuit. The State promised before trial began it would present statistical evidence to show how misleading marketing by J&J’s Janssen Pharmaceuticals unit led doctors to prescribe too many of the company’s products, J&J says, but never offered anything but expert opinions and a frequently repeated blue chart showing opioid deaths rising and falling in tandem with sales of prescription painkillers. 

The state’s main expert witness was Dr. Andrew Kolodny, a onetime advocate for the use of opioids to treat chronic pain who went to work as a consultant for Oklahoma and other plaintiffs after he was threatened with bankruptcy over opioid litigation. Kolodny accused J&J of being the “kingpin” behind Oklahoma’s opioid crisis because it once owned a pair of companies, Noramco and Tasmanian Alkaloids, that supplied wholesale opiates to Purdue Pharma and other manufacturers. 

That was a late-breaking development in the case after Purdue settled with the state, agreeing to pay $270 million to settle claims, including almost $60 million to the state’s outside lawyers, including lead trial attorney Brad Beckworth. AG Hunter hired Whitten Burrage, Nix Patterson and Glenn Coffee & Associates, all heavy contributors to his political campaigns, to represent the State on a contingency fee basis. They obtained another $17 million from the state’s $85 million settlement with Teva in June.

The State’s claims that it is liable for sales by its wholesale units fail under state and federal law, J&J says. Oklahoma law doesn’t allow tort claims against suppliers unless they are actively involved in the process of manufacturing products made from them, and Noramco and Tasmanian Alkaloids operated under strict federal regulation governing how much they could produce and who they could sell it to. 

Even if they were somehow liable for selling raw materials, J&J said, the State failed to prove the company is a but-for cause of the opioid crisis since Purdue and other customers easily could obtain the same materials from other suppliers.

Core to J&J’s defense is the fact it never accounted for more than a tiny fraction of legal opioid sales in Oklahoma and its two main products, the fentanyl-containing Durgesic patch and Nucynta, a pill introduced in 2009, were relatively hard to abuse and unpopular with addicts. Oklahoma never presented any evidence of Janssen’s market share, the company said, while state records show it never exceeded 2% of prescriptions reimbursed by state health plans. 

“After more than 20 days of State evidence and testimony before this Court, it is now plain for everyone to see this case was never about Janssen’s opioid products,” the company said. 

The State also failed to establish an essential element needed to hold J&J liable for the entire $17 billion it is seeking to abate its opioid crisis, J&J said. Under Oklahoma law, so-called joint-and-several liability is available only if injuries are indivisible, such as when multiple companies leak pollution into the same waterway. 

In this case, the State could easily identify Janssen’s contribution to the opioid crisis by identifying patients who overdosed on its products and doctors who succumbed to its marketing, but failed to do so. The State didn’t present a single person who became addicted to Janssen products as a witness and it didn’t name a single doctor who relied on misleading information to prescribe the company’s products.

Oklahoma also downplayed its own responsibility for opioid addiction and death, including delaying until 2015 the implementation of a mandatory prescription monitoring program to prevent patients from “doctor shopping” multiple prescribers to get excessive supplies of drugs. 

The company ended with an explicit appeal to Judge Balkman to walk away from the task the State has given him. 

“Authorizing and funding decades of government spending programs to address daunting social problems is the work of legislatures – not courts,” the company said. The State’s $17 billion abatement plan “resembles no judicial remedy ever issued by an American court. It is, from beginning to end, an appropriations bill, submitted to the Court rather than the floor of the Oklahoma legislature.”

 

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Oregon: rewriting “tapering guidelines”… but.. still target goal is the tapering of opiates to ZERO ?

Posted on July 10, 2019 by Pharmaciststeve

Oregon Opioid Taper Back in The News

www.nationalpainreport.com/oregon-opioid-tapering-back-in-the-news-8840412.html

Posted on July 10, 2019 by Ed Coghlan

While momentum for the forced tapering proposal for Oregon Medicaid patients promoted by the Oregon Health Evidence Review Commission has stalled for now, thanks to pressure from local pain patients and national pain experts, the state’s Opioid Taper Guidelines Task Force is continuing its work.

The Task Force meets on Friday July 19th and is considering a proposal to dramatically expand the criteria for inclusion in a forced taper.

The language now includes mental health comorbidities that can “develop or worsen” with opioid therapy.

The important word, according to those who have read the guideline, is “develop”. This, according to advocates, leaves interpretation not about what is happening but what might happen without any protection for the chronic pain community.

OHA says it is convening experts on the Oregon Opioid Taper Guidelines Task Force. OHA says, “The resulting guidelines from this task force will supplement the Opioid Prescribing Guidelines for Chronic Pain to help patients and prescribers’ approach opioid tapering with best practices in mind.”

The Oregon Opioid Taper Guidelines Task Force currently meets publicly monthly through at least September 2019.

One of its members has raised the eyebrows of advocates who believe the Task Force may be predisposed to an anti-opioid stance—despite declaration from practically all in the pain management community that opioids have a role in the treatment of chronic pain.

Paul Coelho, MD is the Medical Director of the Pain Clinic at Salem Health and is also a board member of Physicians for Responsible Opioid Prescribing (PROP). Its executive director, Dr. Andrew Kolodny has been a hired gun…to the tune of $700+ hourly… in testifying in trials against pharmaceutical companies who produce opioid medication.

As Oregon continues to push for more rigid opioid prescribing guidelines, it’s important to remember what the FDA said on the matter earlier this year.

Recently, the FDA has received reports of serious harm, including serious withdrawal symptoms, uncontrolled pain and suicide, in patients who are physically dependent on opioid pain medicines when these medicines are suddenly discontinued or when the dose is reduced too quickly, often without adequate patient communication, follow-up or support.

If you wish to contact the state of Oregon about the issue prior to its meeting on July 19th, contact Lisa Bui, 971-673-3397, 711 TTY, or ootg.info@dhsoha.state.or.us at least 48 hours before the meeting.

For more on the Oregon Opioid Taper Guideline Task Force, click here.

 

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DEA: all laws, morals or ethics are just SUGGESTIONS – don’t worry WE ENFORCE THE LAWS (on everyone else)

Posted on July 9, 2019 by Pharmaciststeve

Watchdog: DEA supervisor had ‘improper personal relationship’ with confidential source

https://thehill.com/blogs/blog-briefing-room/news/452181-watchdog-dea-supervisor-had-improper-personal-relationship-with

A Drug Enforcement Administration (DEA) group supervisor had an “improper personal relationship” with a confidential source and approved payments to the source without justification, according to a report from the Justice Department’s Office of Inspector General.

The Department of Justice (DOJ) watchdog started the investigation following a tip from the DEA’s Office of Professional Responsibility saying the unnamed supervisor both made the unjustified payments and “caused false statements to be made” to justify them.

The report also found the supervisor misused their government vehicle to take the source on dates and shared nonpublic information relating to personnel matters within the DEA, and that their then-supervising DEA assistant special agent in charge (ASAC) authorized the payments.

The probe also found the source went on two personal trips with the supervisor and the supervisor allowed the source to accompany them on visits to the supervisor’s family and friends, none of whom were made aware that they were a DEA source.

“The OIG concluded that the GS violated DEA policy and federal law when the GS approved payments to the CS without proper justification and when the GS approved a form relating to the CS knowing that it included false statements,” the report states.

“Further, the OIG concluded that the ASAC failed to properly supervise the GS,” the OIG summary adds.

While the OIG found the conduct was a violation of DEA policy and federal law, criminal prosecution was declined.

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