http://www.whsv.com/content/news/West-Virginia-AG-says-new-opioid-directive-came-from-his-DEA-lawsuit-475689823.html

According to Attorney General Patrick Morrisey, his December 2017 lawsuit was the cause behind Attorney General Jeff Sessions’ new directive for the DEA to change its regulation establishing how many opioid pills can be manufactured each year.

The announcement came just hours before a key deadline in Morrisey’s lawsuit, which sought greater transparency and broader input in the process the DEA uses to establish those limits.

He says evidence of diversion has been ignored for years in setting those limits, and he moved to suspend his lawsuit Thursday after getting the federal directive.

“The era of unlimited supply must end,” Attorney General Morrisey said. “We are losing too many neighbors, too many friends, too many sons and too many daughters to senseless death.

“The DEA’s quota system is fundamentally broken,” Morrisey said. “For far too long, it served the industry’s wants, instead of the patients’ needs, inexcusably neglecting evidence of diversion to rely on a formula that continues to kill hundreds each day. This must stop.”

Morrisey says the new process should require the DEA to formally seek input from the Department of Health and Human Services, Food and Drug Administration, Centers for Disease Control and Prevention, as well as every state.

He says that would be “a reversal from years of reckless oversight and abject failure.”

“I heartily applaud Attorney General Sessions for the major step he is taking and for his continued collaboration with our office to protect West Virginians from this deadly scourge of opioid excess,” Attorney General Morrisey said. “I am also appreciative of President Trump’s dedication to addressing the opioid problem, as it represents such a stark departure from the past.”

You can read Morrisey’s lawsuit here, Sessions’ directive here, and Morrisey’s motion to suspend the suit here.

legal opiate prescriptions in 2016 was less than 2006 and DEA cut opiate prescription manufacturing quotas in 2016.. again in 2017 and again in 2018… many opiates production quotas are abt 50% of what they were in 2015. .. and this numb-nuts attorney wants a larger cut… because the citizens of his state because of genetics, or socioeconomic reasons they have decided to abuse and/or be diverters of controlled substances.

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www.rxinjuryhelp.com/news/2018/03/02/unnecessary-use-of-fluoroquinolone-antibiotics-prompts-new-cdc-warning/

The U.S. Centers for Disease Control (CDC) is now warning doctors to prescribe fluoroquinolone antibiotics – a class of drugs that includes Levaquin, Avelox and Cipro – only when “absolutely necessary” because of their potential to cause serious adverse events.

Fluoroquinolones Often Prescribed for Uncomplicated UTIs, Viral Respiratory Conditions

The CDC warning follows the release of data suggesting that the drugs are often used to treat conditions that do not require antibiotic treatment or those with a different recommended first-line therapy,

According to a report published in Clinical Infectious Diseases, 1.5 million fluoroquinolones were prescribed to adults during ambulatory care visits in 2014. Genitourinary conditions (24.5%) and respiratory conditions (21.6%) accounted for the majority of these prescriptions.

Nearly 20% of fluoroquinolone prescriptions were written for patients with uncomplicated urinary tract infections or viral respiratory infections and bronchitis that don’t require antibiotic treatment. What’s more, fluoroquinolones were the MOST COMMONLY prescribed antibiotic for uncomplicated UTIs (40.3%) and the third most commonly prescribed antibiotic for respiratory conditions.

“Fluoroquinolones’ side effects can involve tendons, muscles, joints, nerves and the central nervous system, or could lead to life-threatening Clostridium difficile infection, which causes diarrhea that can lead to severe colon damage and death,” the CDC said in a statement responding to the report. “Because of these serious side effects, in 2016, the [U.S. Food & Drug Administration (FDA)] issued a warning advising health care providers to not use fluoroquinolones for conditions for which alternative and effective treatment is available and when the potential risks outweigh the benefits.”

Fluoroquinolone Side Effects

The FDA warning followed an agency review that suggested fluoroquinolone antibiotics could cause potentially permanent side effects involving the tendons, muscles, joints, nerves and central nervous system. At the time, the FDA required fluoroquinolone manufacturers to add this information to the Black Box Warning included with the drugs’ prescribing information. A Black Box Warning is the most urgent type of safety notice.

That warning was only the most recent FDA alert to focus on fluoroquinolone antibiotics. In August 2013, the agency ordered the drugs’ manufacturers to modify label information regarding their potential to cause a serious nerve disorder called peripheral neuropathy. While mention of the condition had been added to the prescribing information in 2004, the FDA determined that the labels did not reflect the possible rapid onset of the condition, or the potential for permanence.

In 2008, information regarding the potential for tendon damage – including ruptures and tears of the Achilles tendon – was added to the drugs’ Black Box Label.

Fluoroquinolone Antibiotic Lawsuits

Hundreds of people are currently pursuing peripheral neuropathy lawsuits against the manufacturers of Cipro, Levaquin and Avelox. Among other things, plaintiffs accuse the drug companies of downplaying this risk and failing to provide doctors and patients with adequate safety warnings.

Claims have also been filed on behalf of patients who suffered aortic injuries – including  aortic aneurysm and aortic dissection – allegedly associated with the use of Cipro, Avelox and Levaquin.

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It is amazing how the media can start down one story path and end up with prescribers and legal opiates being the problem..  Here is a kid that is suppose to be the 16th best hockey player in the USA.  Apparently a over achiever, nothing wrong with that… but apparently accepted a offer from someone before a game to “take the edge off” and it was a opiate (Heroin) … and he never played another competitive game without his “little helper”… I believe, in athletics that is considered “doping/cheating”…  But those illegal acts by this kid – using a illegal substance and taking an illegal substance to help him win in a competitive team sport not part of this media’s message.

Mrs Kruczek and Ainsley headed directly to about prescribers … OVER PRESCRIBING… as the cause of all of these deaths. In this particular case it would appear that this kid’s “gateway drug” … was directly from the street and no prescriber was ever involved in giving him a prescription opiate.

https://www.nytimes.com/2017/06/14/business/media/fox-news-fair-and-balanced.html

Apparently this article explains a lot 

Fox News Drops ‘Fair and Balanced’ Motto

www.nytimes.com/2017/06/14/business/media/fox-news-fair-and-balanced.html

Mr. Ailes, who died in May, created the slogan with both purposes in mind. He coined the phrase when he and Rupert Murdoch founded Fox News in 1996, and it stuck.

Executives at Fox News acknowledge that it is rebuilding.

This year, Fox News has continued its yearslong streak as the top-rated cable news station over all, beating its rivals MSNBC and CNN in total viewership.

But the loss of the anchors Megyn Kelly and Bill O’Reilly has taken a toll in prime time. In May, MSNBC was the highest-rated network in a key industry category, weeknight viewers 25 through 54, for the first time in nearly 17 years.

On Wednesday, executives at Fox News played down the shedding of “Fair and Balanced,” saying that the move was strictly a marketing decision and that the network’s approach to news coverage had not changed.

One senior network official emphasized that the slogan was officially dropped last August and virtually no one had noticed.

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Kentucky House votes to tax opioids to close budget gap

http://abcnews.go.com/US/wireStory/kentucky-house-votes-tax-opioids-close-budget-gap-53447557

For six years, a pharmaceutical distributor sent more than 50 million doses of prescription opioids to five eastern Kentucky counties, enough for every person there to have 417 pills each.

Kentucky’s attorney general has sued that company and others like it. Thursday, state lawmakers voted to tax them.

In a state with the fifth highest drug overdose death rate in the country, Kentucky’s Republican-controlled House of Representatives approved a tax on prescription opioids Thursday. If approved by the state Senate, Kentucky could become the first state in the country to tax the addictive prescription painkillers that have spurred a wave of addiction across the country.

Lawmakers say the goal is to reduce the number of opioids available in Kentucky. But they won’t use the money from the tax specifically for drug treatment, instead using it to fund public education and other services.

“These pills are profiting the big pharmaceutical drug companies billions and billions and billions of dollars a year. You know how much our state budget gets? Zero,” Democratic Rep. James Kay said.

As the opioid epidemic rages across the country, state and local governments have filed hundreds of lawsuits against pharmaceutical companies and distributors to recoup some of the costs to their health care systems.

Kentucky’s proposal is a step in the other direction, using taxes to fill sparse state coffers while discouraging aggressive prescription of the drugs.

“I think it could help reduce aggressive prescribing,” said Dr. Andrew Kolodny, director of opioid policy research at Brandeis University and an expert advising the court in lawsuits against pharmaceutical companies. “Right now it is too cheap and easy to give a patient a narcotic when they have a pain problem.“

Kentucky is one of at least 13 states with pending legislation to tax opioids, according to the National Conference of State Legislatures. None of those proposals have been enacted.

The Kentucky proposal would tax each dose of opioids 25 cents.

State officials say it would generate about $70 million per year. In Minnesota, Gov. Mark Dayton has proposed a “penny a pill” tax on narcotic medications to raise about $20 million to pay for drug treatment programs.

Kentucky’s opioid tax revenue would not be set aside for drug treatment, instead going to fill a budget gap caused by the state’s struggling pension system.

“I think that’s a mistake,” Kolodny said. “States (need) to be investing and building out a treatment system that doesn’t really exist yet. This is a very sensible place to get that money.”

Some Kentucky lawmakers complained that the opioid tax, coupled with an accompanying 50-cent tax hike on cigarettes, disproportionately affects poor people.

But the proposal gives Kentucky’s attorney general authority to prosecute drug companies that pass the tax along to their customers.

That might not be legal, according to Nick McGee, spokesman for the Pharmaceutical Research and Manufacturers of America. He said that idea, plus the tax itself, have “some serious legal and policy questions.”

“Taxing prescribed medicines that people legitimately rely on to raise revenue for a budget shortfall is a pretty problematic precedent,” McGee said.

It’s unclear how the proposal will fair in the state Senate, a smaller legislative body that is dominated by Republicans. Senate President Robert Stivers said it would be “difficult” to pass any tax increase without a comprehensive reform of the tax code.

Republican Gov. Matt Bevin told WSON radio he would “reserve my thoughts” on the opioid tax. But later in the interview, he indicated he would not favor raising taxes just to balance the state budget.

“They are trying to put certain monies back in certain areas based on certain political pressure, when I think we need to have a collective effort in Kentucky,” Bevin said.

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https://www.medpagetoday.com/publichealthpolicy/opioids/71434

WASHINGTON — Interoperability, predictive analytics, e-prescribing: these were some of the terms buzzing around the dais at a hearing of the Senate Health, Education, Labor and Pensions Committee on Tuesday.

The focus of the hearing was to solicit expert input on the role of technology and data in addressing the opioid crisis. The committee is currently drafting legislation related to the epidemic, which it plans to mark-up as soon as late March.

Specifically, Chairman Lamar Alexander (R-Tenn.) asked the experts how the federal government can use the data it collects to identify and stop the overprescribing of opioids.

Sen. Patty Murray (D-Wash.), the committee’s top Democrat, also spoke of the challenge of interoperability with prescription drug monitoring programs, noting that “the prescription a patient receives in one state may not show up in the system of another state. Two doctors in different states may not see they are writing prescriptions for the same patient.”

The concern is that providers may miss meaningful data that could alert providers to signs of a substance use disorder, she added.

Snezana Mahon, PharmD, vice president of clinical product development for pharmacy benefit manager Express Scripts in St. Louis, offered several recommendations to the committee.

First, pass the “Every Prescription Conveyed Securely Act,” which would mandate e-prescribing for opioids for all Medicare enrollees, she said.

“Encouraging e-prescribing of controlled substances would restrict pharmacy shopping [and] enable better prescription tracking, as well as reducing fraud waste and abuse,” Mahon explained.

Second, limit prescription for a first-time opioid user to 7 days (with exceptions for cancer, hospice, and palliative care) in keeping with the “Opioid Addiction Prevention Act,” she said.

Mahon also urged Congress not to mandate coverage for abuse-deterrent opioids saying that it was a “flawed approach” because some providers and patients mistakenly believe such products are less addictive.

Sherry Green, CEO of Sherry L. Green & Associates and co-founder of the National Alliance for Model State Drug Laws in Santa Fe, New Mexico, urged the committee to establish a federally funded hub that would break down the data silos and have consistent standards.

Green told MedPage Today after the hearing that there needs to be standards in each state for three key elements: what data is recorded, who can access it, and for what purpose.

In addition, she recommended that all states should integrate Prescription Drug Monitoring Programs (PDMP) into electronic health record (EHR) systems.

“We’ve got to get this information integrated seamlessly into these [health information exchanges] and [EHR] to get this information to professionals during their clinical work flow, so that they have it when they’re trying to make a decision,” she said.

In his testimony, Sanket Shah, a clinical assistant professor of health informatics at the University of Illinois at Chicago, focused on the impact of predictive analytics to leverage data, and identify warning signs of potential opioid dependency.

He cited a recent study that found “each refill and week of opioid prescription is associated with a large increase in opioid misuse among opioid naive patients. The data from this study suggest that duration of the prescription rather than dosage is more strongly associated with ultimate misuse in the early postsurgical period.”

Shah also stressed that “To truly have predictive analytics we need more data sources.”

He explained in a follow-up email to MedPage Today that self-reported data from people on opioids, after they’re discharged, such as the Current Opioid Misuse Measure, is one type of data that he’d like to see leveraged as it might be more accurate than information patients share in a doctor’s presence. Such data could be used to improve risk assessment tools, and better predict factors leading to relapse for those in recovery, he said.

Shah specifically recommended passage of the Prescription Drug Monitoring Act of 2017, which mandates that any state that receives funding from the federal government for a PDMP must share their data with other states. The bill also includes language around helping fund a data-sharing hub.

He noted in his testimony that the federal government has both “the means and the infrastructure” to develop an “integrated data environment” that could use factors such as social determinants of health, family and medical history and access to complete episodes of care to help health informaticists improve their predictive capabilities.

Alexander balked at the idea of the federal government overseeing a federal hub, and being responsible for data-sharing on a large scale. He pointed to Healthcare.gov and Meaningful Use as examples of government-failed experiments in this same realm.

“Why not instead establish the standards that states can use and why not leave room for Amazon, Google, Delta … Why not let the private sectors come in and offer a way to fill in whatever gap remains after we gradually improve the state PDMP?”

Alexander also asked whether e-prescribing should be tested more gradually, rather than mandated because “the technology is still evolving.”

“Because we have an epidemic, I don’t think we have time to wait. What we can do is carefully figure out what are some of those areas that we could leave some exceptions and give them extended dates of when they should be ready” for e-prescribing, “but certainly the rest of the physician practices that do have the ability to do e-prescribing. We should move on them now,” Mahon said.

As for the idea of a federal hub, Green stressed that the federal government would not need to run the hub.

After the hearing, she suggested to MedPage Today that one program in particular, the National All Schedules Prescription Electronic Reporting program within the Department of Health and Human Services (which has been authorized but not funded), could potentially put out a grant for running such a hub.

Maintaining the right standards would be critical as the data is valuable itself and could become a commercial commodity, if the government isn’t careful.

But “this an area where there truly needs to be a public-private partnership,” she said.

What this group of people are doing.. intentionally, unintentionally or out of ignorance… first of all … faked/forged sets of ID’s are readily available and without giving the healthcare professional the means of validating those ID’s that are presented. A dedicated/organized addict/diverter could cycle thru 1-2-3 office visits a day – 5 days a week… meaning that they could potentially get a 30 days supply of controlled meds 22-66 times a month and NEVER SHOW UP ON ANY PMP DATABASE PRINTOUT… and may never get caught.

They are also ignoring that most/all pts dealing the subjective diseases – including the mental health disease of addiction – are part of a protected class of the Americans with Disability Act and/or Civil Rights Act.

What they are attempting to do is prevent anyone with a undiagnosed disease of addictive personality from encountering “their trigger”, but their trigger may be Caffeine, Nicotine, Alcohol or some substance they got from a friend or off the street… and once they encounter a trigger could cascade into a whole range of experimenting with other substances legal and illegal… They may get to this point without ever having a legal opiate prescription filled for them. Yet, all those millions of chronic pain pts are going to be expected to live in a torturous level of pain to attempt to protect those with mental health issues from falling in that “hole of addiction” that the odds are that they will eventually fall into sooner or later.

To the best of knowledge there has never been any clinical study that documents/proves that abstinence, jail, prison has every been the most appropriate treatment for mental health issues nor a means of controlling/curing mental health issues

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http://thehill.com/policy/healthcare/375903-lawmakers-seek-information-on-curbing-opioid-addition-in-medicare

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tps://www.nbcnews.com/storyline/americas-heroin-epidemic/attorney-general-jeff-sessions-really-going-war-against-big-pharma-n852136

When Attorney General Jeff Sessions appears Thursday at a White House opioids summit, skeptics are likely to hit him with this question: Was his “statement of interest” in support of local governments suing Big Pharma a declaration of war — or saber-rattling?

Defense attorneys who have crossed swords with the federal government before, and advocates who have been pushing the Trump administration to make good on a promise to end the opioid epidemic, say Sessions’ tough talk is likely more of the latter than the former.

“While it is difficult to assign motives to an act of the DOJ, this is a PR move, not a sincere attempt to address the opioid crisis,” attorney David Cattie said.

The targeted drugmakers and distributors most likely are already “preparing to offer compensation to resolve this litigation anyway,” Cattie said. “Is this the administration’s way of signaling to pharma that it wants the companies to settle these cases for some ‘big’ number so the administration can take credit for it? Perhaps.”

Trial lawyer Jesse Gessin said that if the DOJ were serious about holding pharmaceutical company’s feet to the fire, it would join the hundreds of cities, states and other local governments that have accused the companies of creating a crisis by fooling the public into thinking opioids were safe.

“The statement of interest does not make the government a party to the lawsuit,” Gessin said.

It also enables the Trump administration to make it appear they are taking a hard line with an industry that has given millions in campaign contributions to Republicans and Democrats alike.

“The DEA has known for some time that the pharmaceutical manufacturers and distributors were violating federal law, “ Gessin said. “If the government was going to bring a criminal case, they would have brought it. In fact, the government will not commit to joining the multidistrict civil litigation, why should the companies be concerned about criminal liability?”

Greg Williams, co-founder and executive vice president of Facing Addiction, within the National Council on Alcoholism and Drug Addiction, said in a statement they “applaud the Department of Justice for getting involved in this important litigation against opioids manufacturers and distributors.”

“They must be held accountable and must pay billions, not millions, in reparations to our communities and federal government,” Williams said.

Williams also said he expects Sessions will be grilled about what exactly the DOJ will be doing in support of the hundreds of lawsuits that have already landed on the desk of U.S. District Court Judge Dan Polster in Cleveland.

“The attorney general’s move is mostly symbolic,” said Daniel Raymond, deputy director of policy and planning with the Harm Reduction Coalition. “For an administration that has been remarkably friendly to corporate interests, it does beg the question about the Justice Department’s appetite to more directly taking on those companies.”

The deadly opioid epidemic has been a public relations disaster for the drug companies, as they have drawn bipartisan and national scorn.

Gessin said that if he was defending them the fact that Sessions has been talking tough would not cause him to rethink his legal strategy.

“I’d be more afraid of the big time plaintiff’s lawyer on the multidistrict civil litigation than the government,” he said.

How would he defend the drugmakers? Blame the distributors.

“That would be my strategy,” he said. “Blame it on them for not following federal law. That’s why they exist. What good is the distributor if they can’t distribute lawfully? This is really a distribution case, not a manufacturing case.”

Cattie said whatever happens the drugmakers and distributors will wind up the winners.

“This is just the cost of doing business for opioid manufacturers and distributors,” he said. “If I told you that you could make billions of dollars selling a product but that one day the government would make you pay a fine or settlement or some small percentage of that, I am assuming you would sell the product anyway.”

What worries Cattie is what will happen to the doctors who prescribed the opioids.

“It is important to note that while opioids are abused, they are legitimate pain relievers,” Cattie said.

“Sessions is a 1980s drug warrior and I can guarantee you he will be ramping up prosecution of physicians who specialize in pain management,” he added. “For every ‘pill mill’ doctor, there are 100 other doctors whose only concern is the alleviation of human suffering. These doctors are already caught between their oath to their patients and fear that the DOJ will come after them.”

In fact, the DOJ’s new opioid fraud squad’s first indictment was handed down against a Pittsburgh-area doctor, Andrzej Kazimierz Zielke, who allegedly prescribed addictive painkillers to patients and insisted on being paid in cash.

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From a chronic pain pt:

I just tried to get my morphine filled. I take six pill day  15 mg.  the pharmacist said he can only fill 5.6 pills per day . So my dr has to write new perscription. 

Any input Steve. 

Forcing everyone on Hospice ?

My recommendation:

Ask the pharmacist where that “limit” is coming from… one of the basics of the practice of medicine is the starting, changing, stopping a pt’s medication…  So who is attempting to practice medicine on you?   If it is a reject from your insurance ask the pharmacist to give you a screen print of the rejection when he submitted the claim.. or if it the store’s/chain’s policy then a copy of that policy.. if he can’t/won’t do either…then … someone is telling the truth

Response from chronic pain pt:

Steve insurance company playing doctor. My doctor jumped on that and straightened everything out. She is fast . I’m happy. 

Thank you

At least this insurance company just hopes that the pt caves to their demands… and will back down… when the doc pushing back…They are able to DODGE being accused to practicing medicine without a license by getting the pt’s prescriber to re-write the prescription to meet their demands.

In this particular example, the pt’s daily dose was 90 MME… the limit on the published CDC guidelines…  Where this pt’s insurance company came up with the 5.6 doses/day.. is beyond me.

I will leave you with this quote from the movie Galaxy Quest and Tim Allen

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Inhumane Torture Post Surgery

Torture exists in the United States in 2018 for people seeking medical treatment for chronic conditions.

This strong lady went into the hospital to have subtemporal decompression. Subtemporal decompression is removal of part of the temporal skull bone for relief of intracranial pressure.

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