Apparently Express Scripts (PBM) is trying to eliminate independent pharmacies by “hook or crook”
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https://journalrecord.com/2019/12/10/johnson-johnson-appeals-opioid-verdict/
OKLAHOMA CITY – Johnson & Johnson and Janssen Pharmaceuticals, companies ordered to pay $465 million to help Oklahoma recover from an opioid addiction epidemic, will press an appeal with the Oklahoma Supreme Court on claims that a judge made numerous errors in a trial held earlier this year.
The state alleged in a 2017 lawsuit filed against J&J and other drug companies that they created a public nuisance by engaging in aggressive, deceptive marketing that led to a vast oversupply and widespread abuse of prescription painkillers. Tens of thousands of Oklahomans have become hooked on the drugs and many have died.
Some 2,000 similar cases are pending across the nation, including dozens filed separately by towns and counties in Oklahoma. The White House Council of Economic Advisers published a report in 2015 estimating costs of the opioid crisis at more than $500 billion.
Cleveland County District Judge Thad Balkman, who presided over a 33-day non-jury trial held in Norman, ruled that J&J and Janssen did create a public nuisance that affected entire communities and innumerable Oklahomans.
“The defendants’ acts and omissions were a direct cause of the public nuisance in Oklahoma. No act or omission by the state was a direct or proximate cause,” his ruling stated.
On Monday, attorneys for J&J filed paperwork arguing that the judge applied too broad an interpretation of public nuisance law.
“Disregarding a century of precedent, the court ruled for the first time that nuisance liability extends beyond real property use … (and) instead of limiting the state’s claim to Janssen’s allegedly misleading marketing, the court held Janssen responsible for third parties’ statements about medical science and for raw material sales authorized under DEA quotas,” the filing states. “Without explanation, the court found Janssen liable for the entirety of a complex crisis implicating a multitude of criminal, governmental, and medical actors.”
J&J attorneys also claim in their appeal that the company’s marketing of medications approved by the federal Food and Drug Administration should have been protected as free speech, and also that evidence presented by the state wasn’t enough to establish that either J&J or Janssen made false or misleading statements in their marketing of opioids.
“We recognize the opioid crisis is a tremendously complex public health issue and have deep sympathy for everyone affected. We do not believe litigation is the answer and are continuing to work with partners to find solutions,” J&J said in a press release.
The state has filed notice of its own intent to appeal the case. Attorney General Mike Hunter has said $465 million won’t be enough to reverse effects of the opioid epidemic and that the judge should have allowed for periodic reviews to determine if the drugmakers should be ordered to pay more. Hunter’s office didn’t issue any additional comment this week.
This Oklahoma judge DENIED J&J a trial by jury and that meant that this judge basically controlled the entire process and he was a ONE MAN JUDGE/JURY … This appeal doesn’t surprise me because of how this judge handle the whole process. Unfortunately AK will be able to once again state his “opinion” as expert facts AND GET PAID HUNDREDS OF DOLLARS A HOUR DOING IT 🙁
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The US Department of Health and Human Services (HHS) released in October a Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics.1 In the new document, HHS emphasizes that “Opioids should not be tapered rapidly or discontinued suddenly due to the risks of significant opioid withdrawal.” National media portrayed the new guideline as a “reverse course on strict restrictions”2 from the federal government—but does this guidance really reflect such a massive shift? How do the new recommendations interact with pre-existing laws?
The new HHS guideline makes clear that, while there are many instances in which opioid tapering is recommended, rapid tapering or sudden discontinuation of opioids can lead to acute withdrawal symptoms, increased pain, serious psychological distress, and suicidal thoughts. Sudden discontinuation may also increase the chance that a patient will seek out illicit opioids in an effort to manage pain and withdrawal symptoms.
Therefore, in the absence of a life-threatening issue, the agency does not recommend abrupt opioid dose reduction or discontinuation.
Where the HHS and CDC Align
The CDC’s Guideline for Prescribing Opioids for Chronic Pain,3 treated as the gold standard of opioid prescribing guidelines since its release in 2016, made a number of recommendations related to opioid tapering. In nearly every way, the CDC’s recommendations are mirrored by the new HHS guidance. Both federal agencies agree that tapering or discontinuation of opioid therapy should:
Given the agreement between the two documents, it’s easy to question why the HHS Guide was even developed. The answer? To resolve misconceptions regarding tapering and discontinuation that have existed since the release of the CDC’s original guidance.
Within the CDC opioid prescribing guideline, recommendations related to tapering and discontinuation represented a very small part of the document. In large part, the CDC focused on initiating opioid therapy, establishing treatment goals, opioid selection, dosage, duration, and follow-up. Perhaps most notably, and most at-play when it comes to misconceptions that have resulted in unwarranted opioid tapers, is the CDC’s recommendation to avoid increasing dosage to ≥ 90 MME/day.
Misapplication of “90 MME/day” recommendation has been so prolific that both the FDA, as well as the CDC, recently addressed the issue. In early 2019, the FDA issued a Drug Safety Communication4 stating that it had received reports of serious harm in patients who were physically dependent on opioid pain medicines suddenly having their medicines discontinued or the dose rapidly decreased, going so far as to caution against abrupt discontinuation. Not long after, the CDC released its own media statement5 in which it emphasized that 90 MME/day is not a hard limit, and that its dosage recommendation does not suggest discontinuation of opioids already prescribed at higher dosages.
Further, the CDC made it clear that its guideline does not support abrupt tapering or sudden discontinuation of opioids. They went so far as to say that, “…policies that mandate hard limits conflict with the Guideline’s emphasis on individualized assessment of the benefits and risks of opioids given the specific circumstances and unique needs of each patient.”
In recent years, most states have adopted their own laws, rules, and guidelines related to opioid prescribing, and a number of those policies have sections related to tapering and discontinuation. In Arizona, for example, in regard to Workers’ Compensation, a patient’s treatment plan must include the criteria and procedures for tapering and discontinuing opioid use.6 In South Carolina and West Virginia, among other states, guidance states that if opioid therapy is discontinued, a patient who has become physically dependent should be provided with a safely structured tapering and withdrawal regimen.7,8 In all of these cases, state recommendations and requirements may easily be followed while still working within the federal recommendations from HHS.
While the new guidance from HHS aligns with state policies in nearly all cases, there is one state in which clinicians may feel a certain amount of confusion and unease when trying to reconcile local mandates with federal guidance: Kentucky.
The Kentucky Board of Medical Licensure has a rule which states that, when a drug screen or other available information indicates that a patient is non-compliant, the physician shall: do a controlled taper; stop prescribing or dispensing the controlled substance immediately, or refer the patient to an appropriate specialist.9 While this requirement does not completely conflict with federal guidance, in that the “or” statement allows for referral to a specialist rather than tapering or discontinuation, it would be easy for a clinician to assume that they must taper or immediately discontinue—particularly if they intend to keep treating the patient themselves.
It is worth noting that Oregon-based clinicians may also feel a disconnect between state and federal policies, as Oregon’s Medicare program previously had a strict tapering mandate for certain patients, but this mandate has recently been relaxed to allow for individualized tapering plans.10
For clinicians that have been operating under both real and perceived pressure to reduce and/or discontinue their patients’ opioid prescriptions, it may feel as if the new HHS guidance is a huge shift in federal policy. Upon closer inspection, however, the new guidance supports nearly all pre-existing federal and state guidance in regard to opioid tapering. What the guidance does differently is to rephrase and clarify opioid tapering recommendations in order to help clinicians avoid the many misperceptions and misapplications that have been associated with the opioid prescribing policies released in recent years at the federal, state, and even local levels.
If your state currently has, or later implements, a policy related to opioid tapering that conflicts with a federal policy, which policy is controlling?
So, what is the bottom line for your practice and patients? As with all medical decisions, opioid tapering and discontinuation should be based on the individual patient’s circumstances. There is no one-size-fits-all approach and in every case the clinician needs to weigh the risks and benefits of the current therapy, develop an individualized care plan with their patient, and re-evaluate and adjust that plan regularly.
Based on direct quotes from the CDC and HHS opioid guidelines discussed in this column, here are some practical takeaways for clinicians to consider:
Thus, these guidelines clearly recognize that some patients with chronic pain benefit from opioid treatment, including those who may benefit, or are benefitting, from >90 MME/ day. They do not advocate: never initiating opioids above a specific dose; reducing every patient on opioids to a dose below that dose; tapering all patients off opioids; or avoiding starting any chronic pain patient on opioids. Instead, clinicians are encouraged to carry out careful initial and ongoing assessments that address function, behavioral health, red flags (eg, addiction risk, misuse, noncompliance), and other modalities.
Once again the DEA seems to be MIA… so what if they decide that they are perfectly happy with the original CDC guidelines and ignore these clarification(s) and revisions and continue to raid/shut down practitioners’ offices based on their previous interpretations of the CDC guidelines. Because what is the DEA going to do… go after the various CARTELS that it is claimed generated > 100 billion/yr and are heavily armed and tend not to take kindly to anyone who tries to interfere with their business plan.
we have had 115 LEO deaths in 2019 https://www.odmp.org/search/year including 5 who work at the FEDERAL LEVEL ..https://www.odmp.org/search?state=U.S.%20Government&from=2019&to=2019&filter=nok9 none labeled as working for the DEA. Does this suggest that anyone working for the DEA has the lowest risk of anyone in law enforcement to be killed while on duty ?
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https://dlike.io/post/@arunava/evernote-complies-with-dea
I don’t know if i should categorise this under Tech but anyways let’s mobe on with it. It seems Evernote which is a Note Taking App and very useful if I may add recently gave data on an User of theirs to the DEA. Now it has been notified that the user was allegedly a Dark Web Drug Dealer so that sounds good in a way but since it was only alleged this does leave a sour taste in my mouth.
The DEA did get warrants to do so but still Evernote should have resisted a little as the next one could be anyone else. This does serve as a breach of privacy as many people do keep important stuff on that App and after this news came out a lot of users are already jumping ship as they are looking for better Privacy options.
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I’m so energized by two meetings in DC this week with key stakeholders focused on policy solutions that promote individualized, multimodal, comprehensive, person-centered, integrative pain care. Some takeaways – our voices do change policies; earlier access to treatment is key; we must implement HHS best practices pain management task force report recommendations; increasing awareness/education about what comprehensive pain care looks like is of highest priority. All these efforts – and so many more – make a difference together. No shortage of good work to do. patientaccess afbpm voicessummit aacipm acute chronicpain @AACIPM Kate Nicholson Dania Palanker Cindy Steinberg Jianguo Cheng MD, PhD, FIPP John Prunskis Vanila M. Singh MD
Maybe it is just me… but looking at the sign from this “solution summit” and looking at the “fine print” VOICES FOR NON-OPIATE CHOICES
POLICIES TO ADDRESS ACUTE PAIN AND OPIATE ADDICTION IN AMERICA
It appears that this “summit” with all these “important people” are apparently trying to validate – the false belief – that all opiate prescribing leads to ADDICTION.
I wasn’t at this summit… but… nothing posted about it – that I read – mentioned any treatment of chronic pain. There is no mention of anyone representing the DEA nor the CDC, but I get the gist that of the meeting was in line with the DEA’s and other entities misapplying of the CDC’s 2016 opiate dosing guidelines. Color we skeptical in how the results of this summit could benefit the chronic pain community
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Here is a post from just YESTERDAY — WORSE CASE — of having a ESI !! Epidural Steroid Injections / R.I.P. Dearest Jimmy / FDA-AADPAC
There is a lot of $$ change hands giving pts ESI’s and if the pain clinic is not giving the pt oral opiates… then the pain clinic practitioner has little concern about the DEA’s oversight of their practice… since no controlled substances are used in ESI’s.
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Some 60,000 spinal cord stimulators are surgically implanted every year. They send a mild electrical current to the spinal cord to relieve chronic pain. An NBC News investigation in partnership with the Associated Press found tens of thousands of injury reports had been filed with the FDA.
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