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  • Judge Ruled Against the Plaintiffs in Opioid Litigation in California

    An article in Reason came out yesterday about the ruling for the Defendants (four drug companies-Teva, Johnson & Johnson, AbbVie, and Endo) in opioid litigation. This is huge for our community. The Judge said the  Plaintiffs failed to prove the charges of public nuisance and false advertising. Superior Court Judge, Peter J. Wilson wrote a 42 page ruling. This was the first of thousands of cases filed across the country regarding the "opioid crisis," filed in 2014. The Plaintiffs' claims were:

    1. The companies used false advertising
    2. They engaged in unlawful business practices
    3. They created a public nuisance

    Judge Wilson ruled the Plaintiffs failed to prove any of these claims. Some direct quotes from Judge Wilson's ruling:

  • Minnesota

    CPP advocates in Minnesota have been working hard to pass legislation to protect intractable pain patients. 

    Video of hearing on March 24, 2022. A CPP and Dr. Beth Darnall testified.

    Minnesota Stat. 152.125 - intractable pain 

  • New Hampshire

    Please join New Hampshire's Don't Punish Pain Rally Facebook page to network with other advocates from NH.

    New Hampshire’s Bill, HB1639, was signed by Governor Sununu in August of 2020. It was originally created as a separate bill, SB 546, but was later added to Omnibus Bill HB1639. 

    The bill was created and passed with the amazing efforts of Bill Murphy, CPP advocate and original member of Don't Punish Pain Rally. When the bill was signed into law, Bill Murphy created this tweet

    "New Hampshire’s Bill, HB1639, has been signed by Governor Sununu. This Bill addresses the “Treatment of Chronic Pain”. Key sections of this legislation are attached"

  • NPR show 1A with Bev Schechtman and Maia Szalavitz discussing NarxCare and how it affects pain treatment

    NPR's show, 1A, had our VP, Bev Schechtman on a panel on November 11, 2021. The name of the segment is "Against The Pain: The Opioid Crisis and Medication Access." NPR became interested in the show after reading Maia Szalavitz's article about NarxCare in Wired.  Listen to the recording of the show.  You don't want to miss this!  

    "We have these people who have been on these meds for 20-30 years and doctors are under extraordinary pressure to get their numbers down" ~Maia

    "In a criminalized environment where doctors are not only afraid of losing their license, but of going to prison, and where patients are being squeezed because they're being told 'you can only have x amount because otherwise my numbers are too high,' you end up with a lot of untreated pain." ~Maia

    "I'd like to see context added (to these algorithms), if someone moves 3 times in 2 years, it needs to not look like they're 'doctor shopping,' I'd like to see a return to individualized care and stop these arbitrary guidelines where people are having a hard stop on what they can and can't have and they're not looking at what's actually going on with the patient." ~Bev

    "I was treated like a criminal; I was mocked, laughed at, scolded, I was embarrassed...I felt revictimized." ~Bev

    "There are tremendous gender and racial bias in these algorithms and in this false narrative." ~Bev

    "No one should ever be denied care, that's just cruel and unusual punishment." ~Dr. Dombrowski

    "Electronic Health Records are just a billing system, not to make patient care better...if you hit something by accident like malingering, next thing you know it's in the chart permanently. It's dangerous." ~Dr. Dombrowski

    Dr. Mark Ibsen, who is a fierce advocate for the CPP community, recorded the show with running commentary.  

  • Oklahoma's Bill SB57 and Hearing About Harms From Forced Tapers

    Please join Oklahoma's Don't Punish Pain Rally Facebook page to network with other CPP's in Oklahoma

    Oklahoma's Intractable Pain Bill

    In April 2021 Oklahoma's Bill SB57 unanimously passed the House and Senate.

    Hearing About Harms From Forced Tapers

    On November 1, 2021 the Oklahoma, Alcohol, Tobacco, and Controlled Substances Committee held a hearing. The  purpose was to discuss an interim study that was done about rapid de-prescribing and the horrific effects it has had on patients.  This was requested and organized by Tamera Stewart-P3Alliance Policy Director, Julia Heath-P3Alliance Director of Medical Initiatives, along with their leadership team.

    Some of the speakers were Beth Darnall ,PhD from Stanford University, Dr. Vanila Singh, other doctors, a pharmacist, and chronic pain patients.

    Beth Darnall, Phd:
  • Our VP, Bev, Was a Guest On Pharmacy Podcast Network!

    "Where's the Patient's Voice in Evidence-based Treatment & Research?"

    Pharmacy podcast 2

    Part 4 in the series "Pharmacist and Physician Opioid Collaborative"on Pharmacy Podcast Network.

    Listen as Todd Eury, from Pharmacy Podcast Network, asks Bev a question that is long overdo..."What is the patient's perspective?"

    "No one ever asks the patient what we think, we are kind of shoved out of it." ~Bev Schechtman

    "But what they're missing, Bev, is they're missing the empathetic bedside manner to look you in the eye and give you a sincere little smile, showing they're there for me as a patient." ~Todd Eury

    "We feel like everyone around us is going to treat us as though everything we say is a lie, that we're going to try to get out of whatever it is they think they're trying to catch us in, and we can't trust any of them." ~Bev Schechtman

    "The way they set up the system patients can't be honest with our providers." ~Bev Schechtman 

      

    "

  • Podcast S1 E13 - Part 4 - PDMP/NarxCare and Law Enforcement

    Season 1 Episode 13 - 10/31/22

    Link to Episode

    This is part 4 in our NarxCare/PDMP series. We interview Jacob James Rich. This episode focuses on PDMP harms, law enforcement's access to the PDMP, and whether HIPAA protects patients from PDMP data being shared.

    Jacob James Rich is a researcher at the Cleveland Clinic Center for Evidence-Based Care Research, studying epidemiology and biostatistics at the Case Western Reserve University School of Medicine. Jacob also works as an analyst for Reason Foundation, focusing on healthcare policy. He has written extensively on drug policy topics, such as the consequences of prescription drug monitoring programs (PDMPs) on patient access and overdose mortality. Jacob is currently researching racial disparities in drug enforcement with CWRU Graduate Student Council's DEI Award.

    Brief: https://reason.org/policy-study/prescription-drug-monitoring-programs-effects-on-opioid-prescribing-and-drug-overdose-mortality/

    Reason bio page: https://reason.org/author/jacob-rich/

    Twitter: @jacobjamesrich

    Attorney Jennifer Oliva's article on PDMP and law enforcement in Duke Law Review - Prescription Drug Policing: The Right to Health Information privacy Pre- and post-Carpenter 

    Links to topics mentioned:

    1. Opioid Rapid Response Program content on The Doctor Patient Forum Website
    2. OIG Toolkit

    Links to podcasts or presentations in their entirety that were shared in this podcast - 

    1. NASCA - "State PDMP vs National PDMP"
    2. Cover 2 Resources - "Strike Force Stops Flow of Illicit Opioids"
    3. Cato Institute - "Patients, Privacy, and PDMP's"
    4. NPR show 1A - "Against the Pain - The Opioid Crisis and Medication Access"

    Kate Nicholson's bio - "Kate Nicholson, JD, is a civil rights attorney and a nationally-recognized expert on the Americans with Disabilities Act (ADA). She served in the U.S. Department of Justice for 18 years, where she litigated and managed cases, coordinated federal disability policy, and drafted the current ADA regulations." - Executive Director at NPAC

    Kate developed intractable pain after a surgical mishap left her unable to sit or stand and severely limited in walking for many years. She gave the TEDx talk, What We Lose When We Undertreat Pain, and speaks widely at universities and conferences and to medical groups."

    Disclaimer: The information provided to you in this podcast is not to be considered medical or legal advice.

  • Podcast S2 E1 - Dr. Carl Hart's opinion on the untreated pain crisis. Where do we go from here?

    Season 2 Episode 1 - 12/9/22

    Link to Episode

    Claudia and Bev interview Dr. Carl Hart. We discuss how pain patients are being harmed by horrible drug policy. Dr. Hart discusses his view of anti-opioid zealots like Dr. Andrew Kolodny and offers to use his platform to help us fight for pain patients.
     I took this bio from his website,drcarlhart.com

    "Carl Hart is the Chair of the Department of Psychology at Columbia University. He is also the Ziff Professor of Psychology in the Departments of Psychology and Psychiatry. Professor Hart has published numerous scientific and popular articles in the area of neuropsychopharmacology and is co-author of the textbook Drugs, Society and Human Behavior (with Charles Ksir). His most recent book, “High Price: A Neuroscientist’s Journey of Self-Discovery That Challenges Everything You Know About Drugs and Society,” was the 2014 winner of the PEN/E.O. Wilson Literary Science Writing Award. Professor Hart has appeared on multiple podcasts, radio and television shows including Real Time with Bill Maher and The O’Reilly Factor. He has also appeared in several documentary films including the award-winning “The House I Live In.” His essays have been published in several popular publications including The New York Times, Scientific American, The Nation, Ebony, The Root, and O Globo (Brazil’s leading newspaper)."

    Here isa link to our survey for pain patients who have lost their pain doctor or are being force tapered.

    Disclaimer: The information provided to you in this podcast is not to be considered medical or legal advice.
  • Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations

    Reporthhs.gov

    The Comprehensive Addiction and Recovery Act of 2016 (CARA) required the Pain Management Best Practices Inter-Agency Task Force to develop the Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations - PDF*, which identified gaps or inconsistencies, and proposed updates to best practices and recommendations for pain management, including chronic and acute pain.

  • Rhode Island Activist/Founder of Don't Punish Pain Rally pushes legislation

    Founder of the Don't Punish Pain Rally/activist's pushes pain patient legislation - Follow this link

  • Roger Chou’s Undisclosed Conflicts of Interest: How the CDC’s 2016 Guideline for Prescribing Opioids for Chronic Pain Lost Its Clinical and Professional Integrity

    An extremely important article was just posted last week on September 17, 2021.  We at The Doctor Patient Forum/Don't Punish Pain have been researching the CDC Guidelines and how they were written.  We specifically have focused on one of the main authors, Dr. Roger Chou.  We had the privilege of collaborating with a palliative care doctor who is also on the AMA Opioid Task Force, Dr. Chad Kollas. Dr. Kollas along with a few other chronic pain patients and advocates worked together to put out this phenomenal article showing in detail the unacceptable conflicts of interests Roger Chou has, and explains in why we need a congressional investigation into how the guidelines were written.  How can you help?  Familiarize yourself with the content of this article, and forward it to your local legislators. your local representatives, your senators, etc.  The following goals are listed at the end of the article:

  • Roger Chou’s Undisclosed Conflicts of Interest: How the CDC’s 2016 Guideline for Prescribing Opioids for Chronic Pain Lost Its Clinical and Professional Integrity

    An extremely important article was posted on September 17, 2021. We at The Doctor Patient Forum/Don't Punish Pain have been researching the CDC Guidelines and how they were written.  We specifically have focused on one of the main authors, Dr. Roger Chou.  We had the privilege of collaborating with a palliative care doctor who is also on the AMA Opioid Task Force, Dr. Chad Kollas. Dr. Kollas along with a few other chronic pain patients and advocates worked together to put out this phenomenal article showing in detail the unacceptable conflicts of interests Roger Chou has, and explains in why we need a congressional investigation into how the guidelines were written.  How can you help?  Familiarize yourself with the content of this article, and forward it to your local legislators. your local representatives, your senators, etc.

    Roger Chou’s Undisclosed Conflicts of Interest: How the CDC’s 2016 Guideline for Prescribing Opioids for Chronic Pain Lost Its Clinical and Professional Integrity


    By: Chad D. Kollas MD, Terri A. Lewis PhD, Beverly Schechtman and Carrie Judy

    “I'm present. Uh … I do have a conflict. I receive funding to conduct reviews on opioids, and I'll be recusing myself after the um, director's, uh, um, um, uh… update.”

    - Dr. Roger Chou, Center for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) Board of Scientific Counselors (BSC) Meeting Friday, July 16, 2021.

    Introduction
    For those familiar with the controversial relationship between the anti-opioid advocacy group, Physicians for Responsible Opioid Prescribing (PROP, recently renamed, Health Professionals for Responsible Opioid Prescribing), and the Centers for Disease Control’s CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016, (2) (hereafter called “the 2016 Guideline”), Dr. Roger Chou’s disclosure represented a stunning admission (3, 4). Chou had originally announced his intention to help influence opioid policy in a 2011 article that he co-authored with PROP’s founders (5), and he was a bold signatory to PROP’s 2012 Petition to the Food and Drug Administration (FDA) to change opioid labeling (6; See Figures 1a and 1b: First page and signatory page.)

  • State Prescribing Laws and Tips on How to Get Legislation in Your State


    States With Legislation Protecting CPP's:


    List of All State Laws About Opioid Prescribing:

    Many states have prescribing laws.  Read An Examination of State and Federal Opioid Analgesics and Continuing Education policies which was printed in 2020. We've also included the pdf version of the article. The purpose of the article is "To evaluate the impact of its Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program, the US Food and Drug Administration (FDA) requested the opioid manufacturers responsible for implementing that program provide information regarding opioid policy changes from 2016 to 2018. FDA also requested a survey of state requirements for pain and opioid prescribing continuing education (CE), the number of prescribers affected by those requirements, the extent to which a REMS-compliant CE program would meet each state’s requirements, and the number of relevant CE programs available."  

    We've included two charts that list prescribing laws state by state

    1. This includes state laws and Continuing Education laws
    2. Laws limiting the prescribing and dispensing of opioids done by the Network For Public Health Law

    See our Advocacy Tools to see tips on how to start the process of getting legislation in your state.

    CPP advocate from NH, Bill Murphy, walks you through the process of getting legislation in your state:

  • Supreme Court Case on March 1, 2022 Can Make All the Difference For Doctors and Patients

    On March 1, 2022, the Supreme Court will hear a case that could make or break the future for pain doctors and their patients. Pat Anson, from Pain News Network, summed it up perfectly in this article "Supreme Court Case May Decide Future of Opioid Prescribing."


    By Pat Anson, PNN Editor

    December 29, 2021

    "Over a dozen patient and physician advocacy groups have filed legal briefs with the U.S. Supreme Court in support of two doctors appealing their convictions for criminal violations of the Controlled Substances Act.

    The nation’s high court has consolidated the cases of Dr. Xiulu Ruan of Alabama and Dr. Shakeel Kahn, who practiced in Wyoming and Arizona. Both doctors were sentenced to lengthy prison terms after being convicted on a variety of charges – including the prescribing of high doses of opioid pain medication to patients “outside the usual course of professional practice.”

    Oral arguments will be heard by the Supreme Court on March 1, with a decision expected later in 2022. Monday was the deadline for interested parties to file “amicus curiae” briefs on the case, which could have a significant impact on opioid prescribing practices nationwide if the appeals are successful. Many doctors have stopped or reduced their prescribing of opioids because they fear being prosecuted under the Controlled Substances Act (CSA).

    “It is no exaggeration to say that CSA prosecutions of physicians have already impaired the treatment of chronic pain,” Ruan’s attorneys said in their appeal. “In response to the opioid crisis, fear of prosecution has increasingly prompted pain management doctors to avoid or reduce opioid prescriptions, even when those decisions leave chronic pain patients without recourse.”

    A successful appeal would mean Ruan and Kahn could ask for new trials, along with dozens of other doctors convicted of similar charges under the CSA.

    “It will also avoid what I see as the chilling effect that it’s had on lots of doctors who are not doing anything even remotely suspicious, but are afraid that they are going to get caught because they prescribe a higher dose, and so they’re dropping people from care or tapering them,” said Kate Nicholson.

    NPAC, along with other advocacy groups and the U.S. Chamber of Commerce, are asking the high court to clearly state how the practice of medicine should be regulated under the CSA. Some argued it is best left to state medical boards, not federal prosecutors or law enforcement.

    “Patients with pain, addiction, or both desperately need appropriate care and treatment. If practitioners are held strictly liable under (the CSA), patient abandonment will become ever more common as practitioners act to avoid scrutiny,” Jennifer Oliva and Kelly Dineen, professors of health law and policy, said in their brief. “Progress in medical care in these areas can only recover if the regulation of medical practice is returned to the province of the states except in narrow circumstances.”

  • Supreme Court ruled in our favor 9-0!

    SCOTUS sides with the petitioner and Health Law Professors in Ruan v. United States 9-0! As explained by Jennifer Oliva:

    The bottom line is that the DEA can no longer say "we think this exceeds the legitimate bounds of medical practice" and then put on their paid experts. INSTEAD, they must prove beyond a reasonable doubt that the doctor KNEW/INTENDED that the Rx was outside the legitimate bounds. What matters is the prescribers knowledge and intent.

    Here is the ruling of the Supreme Court Ruan case. Here are some comments from the lawyers who worked so hard to 

    Some comments about the case from Ron Chapman:

    Many#cpp are wondering what this decision means for them. Simply put, it will be harder to prosecute physicians for medical judgment. We won’t see immediate effects but over time we will get there.

     Jennifer Oliva:

    Once a doctor proves that they are authorized to prescribe a controlled substance (e.g., has state & federal registration), the government must PROVE BEYOND A REASONABLE DOUBT that doc KNEW or INTENDED that their prescribing conduct was unauthorized under the CSA This means that the doc must have known or intended to prescribe outside the legit bounds of medical practice. Not enough for DEA to say "we think this is outside the bounds." Must prove that doc knew it was outside the bounds. Huge win.

    Kelly Dineen:

    This is such a tremendous outcome. Honestly, even the conclusion in the concurrence (which would have required a subjective good faith defense) would have been a win in itself. Amazing news for so many patients. Now we need to get word out to the prescriber.

    Kate Nicholson:

    Today#SCOTUS ruled unanimously in Ruan v. United States, that doctors authorized to prescribe controlled substances can only be convicted for violating the Controlled Substances Act when they intend or know that they are prescribing in an unauthorized manner. The opinion tracks exactly what we argued in our amicus curiae brief and could not have been better for people living with pain. The Court specifically rejects the view that doctors are criminally liable if their prescribing is not in accord with current medical standards. The difference is important, and especially so for doctors treating patients in pain, who might otherwise be deterred from meeting the needs of their patients by the fear that disagreement with their medical judgment would subject them to serious criminal liability. Indeed, Justice Breyer, writing for the Court, specifically singles out the chilling effect of overdeterrence and the importance of distinguishing morally blameworthy from socially necessary and beneficial conduct (i.e., prescribing medication for her patients). Justice Breyer writes, “a strong scienter [or mens rea] requirement helps to diminish the risk of “overdeterrence,” i.e. punishing acceptable and beneficial conduct that lies close to, but on the permissible side of, the criminal line.” The opinion also addresses the “vague, highly general language of the regulation defining the bounds of appropriate prescribing,” and the importance that providers not be convicted criminally for what is essentially negligence: As Justice Breyer writes, “the Government’s standard would turn a defendant’s criminal liability on the mental state of a hypothetical “reasonable” doctor, not on the mental state of the defendant himself or herself.” It is also important thing to note is the concurring opinion by Justice Alito, in which Justice Thomas joins and Justice Barrett concurs in part, concurs fully with the Breyer opinion that the appropriate standard is the subjective state of mind of the prescriber. The government had argued for an objective state of mind standard which we considered to be an oxymoron, and which no Justice agrees with.

    For an in depth explanation read the following:

    March 1, 2022 at 10am EST, Dr. Ruan's case was heard before the Supreme Court.

    We explained it all in detail here

    Attorney Ron Chapman created this post after the case was heard:


    "ORAL ARGUMENT IN RUAN V. UNITED STATES

    The Supreme Court heard oral argument today in the most important healthcare case since 1975, Ruan v. United States . While we were hoping for a glimmer of justice, what we got was a dizzying lesson on grammar, parsing of words, and speed limit analogies. But Justice Gorsuch in his gentle, fatherly cross examination style attempted to bring the argument for petitioners back on track by showing the nonsensical and circular nature of the Government’s argument.

    This issue before the Supreme Court is thoroughly addressed here and if you aren’t familiar go back and read that article first.

    Before we get into the oral argument its important to understand the changes in the case prior to the parties taking the podium. The issue before the 11th Circuit was the failure to give a “good faith” instruction which essentially permitted the Government to convict Ruan under a strict liability standard. The 11th Circuit believed that if his conduct failed to comport with the objective requirements of the practice of medicine then he should be convicted. Petitioners argued that if he subjectively believed he was following objective standards then he should be acquitted. The Government, straying from the 11th Circuit’s opinion pivoted in their opening brief and said that the physician must make an “honest effort to comply” with the objective standard of practice. This is where the train left the tracks. As Ruan’s counsel pointedly argued - the Government’s argument is a malpractice standard gussied up as an objective standard. The Government pivoted so hard that their argument appeared to turn in the direction of the petitioner, arguing that a subjective “honest effort” is enough. But instead of seizing on that juicy opportunity the justices questions sped past the issues at the heart of the case and turned into a confusing digression into the statutory elements of the offense.

    I’ll explain.

    THE INTENT COMPONENT

    21 U.S.C. 841(a) is a drug trafficking statute. It basically says that its unlawful to knowingly and intentionally distribute controlled substances. But an exception exists in the statute for licensed practitioners. Doctors, pharmacists, and other prescribers and dispensers are exempt from the statute as long as their conduct is “for a legitimate medical purpose in the course of professional practice”. In order to address whether the “good faith” of a physician is relevant the court needed to answer a threshold question and that is whether the intent requirement of the statute applies to the distribution or the exception. Thus, the question is: Does the government need to prove that the doctor knowingly and intentionally distributed drugs or does the government have to prove that the doctor knowingly and intentionally prescribed “outside the course of professional practice and for other than a legitimate medical purpose”. If the government needs to prove only that a physician intended to prescribe drugs then the only doctor who escapes this element is one who prescribes in a coma - as Ruan’s counsel pointed out.

    And so the court debated, for some time, whether the intent of the statute was to incorporate the prescriber’s exception as an element of the offense or an affirmative defense to the crime. If its an element, the the intent component must apply to the exception if its not then the intent component only applies to the distribution. Justice Alito seemed to think that the intent element is only related to the distribution and Gorsuch seemed to think that its related to the prescriber’s exception. The other justices didn’t offer much of a position but it seems that Breyer and Alito favor applying it to the distribution because failure to do so creates a statute with two separate intent requirements - one for prescribers and a separate for the general public. Breyer and Alito likely believe that such a reading frustrates the intent of congress in creating the statute.

    ONE GLARING OMISSION

    But in all of the heated debate surrounding the statutory text of the Controlled Substances Act, the Court and the parties missed the most important issue in the case, and all physician prosecutions. Both the Government and Petitioners conceded in their briefs that the standard applied in such cases is an objective standard of practice- which is incorrect. Both United States v. Moore and Gonzalez v. Oregon clearly state that the Federal Government lacks authority to regulate the practice of medicine. The Government only has authority to punish physicians who act so flagrantly that their conduct can be seen as “drug pushing”. And so, the Government’s proof that a physician’s conduct departed from some sort of “objective standard of care” amounts to mere malpractice and something for State Boards to consider - an issue hinted at in Justice Thomas’s final question. Petitioners should have taken the position that the standard of care is relevant in physician prosecutions only to show the jury the reasonableness of the physician’s conduct but in order for the government to fully satisfy the elements of 841(a) they must prove that a physician’s conduct departed so far from the practice of medicine that they ceased practicing medicine at all.

    For more on that point read my article “7 Dirty Words”.

    Instead of arguing this federalist argument, the parties were landlocked by the fact that the court granted Cert on the “good faith” issue which necessarily requires an argument regarding the intent elements instead of elevating above this crucial digression and discussing the authority of the Controlled Substance Act to regulate the practice of medicine generally.

    Tying an objective standard of care to the elements of an 841(a) violation is dangerous because (1) there is no consensus on what that standard actually is in the medical community, (2) it requires juries to grapple with complex and ever changing medical topics, (3) it allows the government and DEA to drive the standards of practice through CDC guidelines, “red flags”, DEA administrative decisions, and other unpromulgated guidance documents. This is dangerous because either subjectively or objectively the parties have permitted the government to take the position that violation of an invisible and ad hoc standard is sufficient for conviction in the first place.

    PREDICTION OF THE COURT’S DECISION IN RUAN V. UNITED STATES

    Predicting the outcome of a pending supreme court case is a bit like predicting the weather 30 days out - it ignores the dynamic interplay of the politics of the court. But I’ll take a stab. The Government abandoned the 11th Circuit’s rationale and the Court has no choice but to reverse the 11th Circuit and permit a good faith instruction or at the very minimum a proper instruction on the intent component of an 841(a) violation. It seems that at least five justices agreed with the fact that the intent requirement relates to the prescribers exception: Barrett, Gorsuch, Kavanaugh, Thomas, and Roberts. I think there are enough votes for reversal. But the tougher question is what relief, if any, can be afforded to doctors in the future given that both sides seemed to agree that an objective standard of practice is the standard in interpreting the phrase “legitimate medical purpose”. Kavanaugh seems to take the position that the statute is vague in the first place and may offer a concurring opinion and discuss vagueness unless he can pull the other four in his direction. But I don’t think he will be successful because of the politics of the Court. Determining that 841(a) is vague as applied to physicians will disrupt the balance of justice and require reversal of a lot, actually a ton, of convictions. And one thing we know about the Supreme Court is that it doesn’t favor such sweeping changes. Now this problem was set up by the Court in the first place in failing to address the statutory text since it was first enacted. Since 1975 we have been left without the voice of the court on this statute allowing the circuits to take differing interpretations and circuit splits as they grapple with the statutory text that was most likely written by a congressional staffer in 1970. But I do expect at least some comment on vagueness.

    In sum, I expect Ruan and Khan to get some sort of relief from this decision because the jury instructions in their case mis-applied the intent requirement of the statute and made drug trafficking a strict liability offense (like speeding) as applied to physicians. But I don’t expect a sweeping change here, I expect a tailored attack on the 11th Circuit’s reasoning and I expect that the Circuit Courts will pigeonhole the Supreme Court’s decision to prevent its broad application to all physicians convicted under the statute.

    There is some good news, potentially, on the horizon though. The Court has held the case of Naum v. United States pending the outcome in Ruan. This is a case where the federalism argument is very much alive. Its a case I have personally handled and if Cert is granted I will be arguing before the Supreme Court. We don’t know why Naum was held by the court but its likely because the Court didn’t want to address the federalism argument until it first decided the more minor issue of good faith and its application to the statutory text."

     

  • The Doctor Patient Forum Podcast Season 1 Episode 3

    Season 1 Episode 3 - 8/29/22

    Link to this episode

    "Interview with attorney Ron Chapman about the targeting of the doctors by the DEA"

  • The Pain Was Unbearable. So Why Did Doctors Turn Her Away? NarxCare is the reason.

    When our VP, Bev Schechtman, was denied adequate pain medication when hospitalized for kidney stones due to having been a victim of sexual abuse, she became obsessed with researching how this could happen. She learned about NarxCare and the Opioid Risk Tool. We, at The Doctor Patient Forum/Don't Punish Pain, have been researching these topics for the past four years. We've reached out to countless investigative journalists only to be shot down. Thankfully, Maia Szalavitz, an author and leader in harm reduction, was interested in telling the story of NarxCare and other risk tools. This was our first piece of national media, and we are so excited to share it with you. We suggest holding on to this article and sharing it with your local legislators.  About half of the states use NarxCare, and this article can help you fight against it. Read about how our country has tried to help the "opioid crisis" by using a risk score algorithm, yet it seems they're only making matters worse.

     

  • The VALUE Study - all of your questions answered

    Table of Contents:


    Introduction

    We've all heard "there is no evidence that opioids work long-term for pain."  This is where the VALUE study comes in. We have answers to your questions here. Much of this information came from an interview Jonelle Elgaway did with the directors of the study, Dr. Beth Darnall and Dr. Sean Mackey. The questions are answered by Dr. Darnall and Dr. Mackey.

    We also include a letter from Andrea Anderson answering some frequently asked questions including what you will encounter in the VALUE Study questionnaires, why they are there, and how you can respond comfortably. 

    What is the VALUE Study?

    We created the VALUE Study in partnership with people with lived experience to bring forward national data to describe the patient experience of those using opioid pain medications to manage long-term pain.

    The VALUE Study is an observational study, meaning we do not apply any interventions or change care in any way. Instead, we observe and collect information directly from patients through three surveys, delivered over one year, to help us understand the patient experience over this timeframe.

    Specific study details involve asking participants with chronic pain taking prescription opioids to complete three online surveys (at the beginning, or “baseline,” at 6 months, and again, at 12 months) and three brief phone calls with study staff. The surveys ask questions about pain, symptoms, pain coping, medication use, mood, sleep, substance use, general health, and well-being. After each survey, a member of the study staff will call enrollees to confirm their current medications over the phone and answer any questions that they may have. When they complete each survey, they will immediately receive an Amazon gift card.

    The study is entirely voluntary, does not impact medical care, and neither medical records nor prescription drug monitoring databases (PDMPs) are accessed. Participants may skip any questions they do not wish to answer. There are many free-text response fields so people can give us ample details about their experiences – an option that is often missing from “forced choice” surveys.


    What is the purpose of the VALUE Study?

    The VALUE Study seeks to accomplish two goals. The first is to address a series of questions about the long-term use of pain medications such as opioids. These questions include:

    • Whether prescription opioids help treat pain and if so, how much;
    • Whether patients experience stigma around receiving prescription opioids;
    • What problems people may experience with opioids prescribed for chronic pain;
    • Whether patients have difficulty accessing opioids that are prescribed to them;
    • Whether or not there are significant risks to the use of opioids when used long term, and if so, what they are;
    • Whether or not those using prescribed opioids for persistent pain develop problematic use or Substance Use Disorder, and if so, how often.

    The second goal is to bring forward the patient voice and experiences about prescription opioids to inform future research and care. The patient experience is often not included in research on the long-term use of pain medications such as opioids, which is a major limitation in our understanding.


    Who can enroll in VALUE?

    Anyone taking daily prescription opioids at a minimum dose of 10 morphine equivalent daily doses (MEDD) is invited to participate. Enrollees do need to be English-speaking and cannot be pregnant. We do the opioid MEDD conversions and calculate the MEDD amount for enrollees.


    What will be done with the information that they collect?

    First, to be included in the VALUE Study, we will need to obtain consent. This consent will outline our use of health information for research purposes. That consent form outlines the details of how the information will be used.

    We will combine the data and analyze the full sample. Then we will also look for subgroups of people and describe them. One of the problems today is that all people/patients with chronic pain are grouped together without appreciation for individual conditions or circumstances. This leads to flawed conclusions that are not only reductive but can be wildly inaccurate for particular subgroups. Subgroup analyses are sometimes done but rarely include information derived directly from patients. Rather, it often is pulled from medical charts or health insurance claims data. Our goal is to bring forward the patient voice and experience, to conduct the most rigorous study possible (while maintaining anonymity) and to publish the results academically and publicly. 

    Briefly, each enrollee’s (i.e., participant’s) data is stored in secured servers maintained by Stanford University. Individual information is not reported or shared outside the study team. Participants are assigned identification numbers in the dataset and all data are coded numerically without names. Your information will be combined with hundreds of other people from around the U.S. We will create an aggregated report on the patient experience. Patients can use a pseudonym if they wish. However, they will need to remember their pseudonym because the study staff will call them three times over the 12-month study and ask using the name provided to us. We will not be accessing any medical records or the state prescription drug databases.


    Why is this study (and others like this) so important?

    The patient voice has been lacking from research on opioids. Further, few studies have examined patient stigma and patient difficulty accessing opioids. Finally, we are conducting a national study and will have the ability to understand what patients are experiencing across the country.

    Sometimes we hear patient skepticism about researchers collecting patient data. However, we cannot address problems if we have poor or no data. Without data, the problem does not exist in the minds of policymakers. When it comes to policy, data is vital. We must provide patient data if we wish to change practices and policies on pain care in the U.S. We have worked closely with patients in designing this study to best ensure privacy protections and anonymity in every way possible.

    Over 15 years ago, we were intrigued that we had little data on the long-term use of prescription opioids to treat chronic pain. We had patients in our clinics that clearly benefited from opioids, and we had patients that clearly did not. And yet, we had little data to allow us to distinguish these groups of patients to help guide shared clinician-patient treatment planning. While this question of the benefits of long-term opioids is recognized by many, including the NIH, we have noticed less interest in answering this question by funding agencies and researchers. Instead, we see a focus on non-consensual tapering off opioids, believing that opioids play no role in chronic pain—a belief not grounded on quality data. We want to help answer this critical question (and the others we listed above). We need the patient’s help and experiences. We want to better understand the role of long-term prescription opioids to manage chronic pain at both the individual and group levels from our research. This information can help better inform clinical guidelines and policy decisions around the use of long-term opioids to treat chronic pain. Without this data, decisions will continue to be based primarily on beliefs that may or may not be accurate.

    We have endeavored to create a study that truly brings forward the patient voice and experience. If patients wish to have their experience count and their voices heard, VALUE (and other studies like VALUE) present such an opportunity.


    Some are concerned the information they share will be used against them. Is that possible or will their info. be protected?

    We appreciate the concerns that people have about their data and take data security and access seriously. The data use will be restricted to the study principal investigators and the study staff. We will not be releasing any individually identifiable data to other parties. To provide some context, between Dr. Darnall and Dr. Mackey, we have over 40 years of human research experience and collected data on tens of thousands of research participants. To date, we have never released individual data to any person(s) or groups outside the research study team. Over more than 20 years, Dr. Mackey has had perhaps two to three requests from study participant’s attorneys to allow them to review their research data to help the participant “prove” they had chronic pain. Dr. Mackey has even refused these requests as they are outside the research scope of this data. Beyond these few requests, neither Drs. Darnall or Mackey have never been asked to turn in any private data, nor have they.


    From where did the funding for VALUE originate?

    The funding originated from the Patient-Centered Outcomes Research Institute (PCORI), as a part of large research award given to Stanford University under principal investigator Beth Darnall. The original award is for the EMPOWER Study, which is a voluntary patient-centered opioid reduction study. This study helps people who wish to reduce their opioid doses do so gradually over the course of one year.

    Sean Mackey conceived of the idea of VALUE, in part because everyone in EMPOWER is voluntarily tapering and we did not have a parallel group that was continuing opioids. We wanted to be able to report upon what happens when people continue opioids and remain stable. As we went along, we realized that there was so much forced tapering in the U.S. that, in part, we needed to study that phenomenon as well. Dr. Darnall recognized the growing need to include these patients’ voices in research, particularly on this topic and expanded the project's initial scope to include that experience.


    Who are the principal investigators involved with this study?

    Beth Darnall is the overall principal investigator for the EMPOWER research award. Sean Mackey is the director of the VALUE Study. While the initial conceptualization for VALUE was his idea and he is leading it, it has evolved to include more of the patient’s experience through the collaboration with Beth Darnall. As a side note, we find that through cross-disciplinary collaborations such as ours (e.g., a physician-scientist working with a psychologist-scientist who are both working with patient advisors), more impactful research can be conducted.


    If I enrolled what can I expect? Clarifying some confusing regarding the VALUE Study

    A letter from Andrea Anderson, answering some frequently asked questions:

    "Due to some concerns and confusion about a few questions in the VALUE study, I wanted to take this opportunity to explain what you will encounter in the Value Study questionnaires, why they are there, and how you can respond comfortably. 
    This study, funded by the federal research organization PCORI, required us to include 4 different questionnaires from several other federal agencies. All 4 of those questionnaires are about different substance use/misuse from alcohol or types of substance use/misuse/abuse. These 4 agency questionnaires are often repetitive because they have similar questions. However, the funders of the study required that we use those questionnaires, and we cannot change the wording of those questions. This is because in federal research, all researchers have to use the same standardized questions so that comparisons, replication, and analyses are possible by others. 
    I want to assure you that you can skip any question you don't want to answer. if a question is poorly worded or difficult to answer, you can always just skip it. Doing so won’t hurt you or hurt the study in any way. You’re not obligated to answer the same question over and over, which can be irritating. There is also nomenclature about drug use that comes from a substance misuse perspective. You might encounter a question such as, “do you think about your drug use often?” You can skip it, or just answer truthfully. E.g., If the answer is, “no, I don’t,” then just answer it that way. That’s what I did. 
    Last, there is a free “text box” provided at multiple sites throughout the study. In those “free text” boxes, you can provide feedback and/or answer questions that were difficult to answer in the actual questionnaire.
     
    For example, there is one compound question that asks about two subjects, constipation and something else. There’s no way to answer it easily. I have talked with the study designers about it, and I believe they tried to add some clarifying language, but we can’t change the question for the reasons I gave above, as well as being unable to change questions in the process of an ongoing research survey. 
    You can use the free text box to write an answer in your own words.
    If you have any questions, please feel free to ask Vicki Bright

    Thank you so much for your participation! We all appreciate you so much. 
    Warmly,
    Andrea"

    Content created by Bev Schechtman on August 6, 2022

  • Timothy E. King, MD

    ***THIS CONTENT IS IN THE PROCESS OF BEING UPDATED AND IS NOT YET COMPLETE***


    Who is he?

    Dr. Timothy E. King is an anesthesiologist and pain management doctor who has made a career off of testifying against other doctors. He cofounded Midwest Medical Legal Consultants, Inc. in 2015. 

    Screenshot 112


     

    Timothy King's Curriculum Vitae 


    His pending patent (an algorithm to "catch" doctors who violate the CSA (Controlled Substance Act)


    Complaint filed about his pending patent


    What's his fee for expert witness work?

    • As of 2017 his hourly rate was $350/hour or $5,000 for a full day of testimony. (He mentions this in his expert witness testimony against Dr. Szyman, transcript linked below).

    What's his total income to date from expert witness work?

    According to the Govtribe, a website that lists funding from the government, he personally made $677,000 since 2013, and his business, Midwest Medical Legal Consultants, Inc., which he cofounded in 2015, has made $1.3 million.

    Screenshot 115     Screenshot 116


    Transcripts


    USA vs Kudmani 1/23/17


    United States v Charles R. Szyman Transcript of Jury Trial Part 1  11/15/17

    Quotes from this case


    United States v Charles R. Szyman Transcript of Jury Trial Part 2  11/16/17

    Quotes from this case


    USA vs Stelmachowski Summary of King's testimony 2/12/18


    USA vs Akers Transcript10/23/19


    USA vs Wagoner Summary of King's testimony  10/31/19


    United States v Dr. Campbell  Transcript part 1  5/19/21

    Quotes from this case 


    United States v Dr. Campbell  Transcript part 2  5/20/21

    Quotes from this case (in the process of being updated)


    United States v Dr. Bauer  Transcript 1   7/21/21

    Quotes from this case (in the process of being updated)


    United States v Dr. Bauer  Transcript 2  7/13/21

    Quotes from this case (in the process of being updated)


    United States v Dr. Bauer    Transcript part 3  7/14/21


    USA vs Dr. Hofschulz  Transcript  part 1  8/5/21


    USA vs Dr. Hofschulz part 1  Transcript part 2  8/6/21


    Quotes from: United States v CHARLES R. SZYMAN Transcript of Jury Trial  11/15/17  (Part 1)

    "Pain is, at its very base, an unpleasant sensation. It's an unpleasant sensation that may be emotional or it may be real." Pg 23

    "mental illness is frequently and generally made worse with opiate use, particularly a high opiate use." Pg. 45

    "I'm not a vending machine. I'm not -- I'm not there where you put a quarter into, pull the lever, get your Milky-Way or your oxycodone or your OxyContin
    and go on your way." Pg. 46

    "The MEQ, the morphine equivalency. Sometimes referred to as MED, morphine equivalent dose. Everything's compared to morphine. And this came about in the cancer world where we had
    people at end-of-life scenarios that weren't doing too good on one medicine and we needed to convert them from, you know, a Dilaudid or a methadone to morphine. So these are factors such
    that we can compare equivalent doses, equivalent doses. So if you're on 40 milligrams of oxycodone I know that that's equivalent to 40 milligrams of morphine. If you're on 10 milligrams of oxycodone I know that's equivalent to 15 milligrams of morphine." Pg. 47

    "Morphine equivalency becomes important, indeed it becomes a critical part of what we do in pain medicine because there are levels, there are danger levels involved." Pg. 48

    "Because we found that as the morphine equivalency dose goes up, so does the chance of side effects. So does the chance of diversion and abuse. So does the chance of death and overdose. Such that when we hit the beginning of the red zone, which we call the region of extreme concern -- so the red light starts at about 100 to 120. When we enter into that zone at
    about a hundred, again just for ease of talking here, we find something very traumatic occurs
    ." Pg. 49

    "The higher the dose the more likely the patient is either going to be diverting or abusing, the more likely the patient's going to be having significant side effects, and the more likely they are to come into the emergency room for an overdose." Pg.50

    "So it's sort of generally been looked at anything above a hundred, except for terminally ill hospice patients, end-of-life scenarios, but except for those situations for chronic pain management anything above a hundred it's almost impossible to justify." Pg.50

    "because palliative care has come into the scene as a separate specialty they deal with end-of-life scenarios so I don't do that so much anymore." Pg.50

    "So typically for end-of-life scenarios we might be talking about max a couple hundred. Maybe every now and then once in a blue moon we might go above that, but in my experience I've not seen it go above that." Pg.52

    "But you can have at the lower end of the spectrum a dependency on such things as tobacco or caffeine or morphine or other opiates. What that really means is that you're using them in a manner that you're not really able to control your use. You still have a craving for them, but perhaps your life is not totally destroyed. You're not having destructive consequences." Pg 52

    "If the pharmacist calls me up and says, you know what, I just saw Mr. Smith and he came in with wads of cash and some shady individuals and, oh, by the way, he looked like he was inebriated, looked like he could barely walk, then I need to pay attention to my pharmacy colleague who is passing this independent information to me." Pg. 58

    If a patient is -- is coming in for an early refill, has called several times to say that they're out early because they took too many medications and is having a history of stolen or lost medications, those three items — that is to say, lost or stolen meds, early refills and early-outs, we call that the abuse triad.: Pg. 58

    " And we know that if we choose to use opiates it's going to make those mental illness issues worse. It's going to make it worse" Pg. 60

    "I do a physical exam and there's nothing to be found, then I worry that maybe it is the mental illness that is contributing to or causing that pain complaint by the patient, in which case for me to choose an opiate treatment regimen would not be appropriate. I would be doing harm. It's going to make those mental illnesses worse." Pg. 61

    "If I prescribe an opiate with Adderall, that's what we call a prescription speedball. What's a speedball? A speedball is cocaine plus heroin. And we know how deadly that is. How deadly that is. Okay. So if I give you not heroin, if I give you Norco or methadone, and instead of giving you cocaine if I give you Adderall, we got a prescription speedball that may not be quite as dangerous as the cocaine/heroin, but it is dangerous and it causes all kinds of problems and it causes death. if a patient is taking a prescriptive speedball, different rates in metabolism. So you
    may suddenly find as one wears off and the other is still in effect the patient could die of an overdose. They were doing fine till the stimulant wore off and all of the sudden they died in their sleep." Pg. 62-63

    "So it's generally recognized that there's really no medical justification -- really no medical justification for using morphine equivalencies above a hundred. So I looked to see if there are morphine equivalencies above a hundred because that implicates safety and overdose risk." Pg. 75

    "It also has a great deal to do with street value. I didn't say earlier but I will now, typically if you're saying, well, what's the value of my pills if I decide to sell them, it's about more or less one dollar per milligram...So we look at greater than a hundred milligrams both from a street value standpoint and an overdose risk standpoint." Pg. 75

    "Well, they're referencing what I talked about in terms of is the patient being prescribed a recognized high-risk combination like -- for instance, like the Adderall and the opiate or the prescription speedball as I referred to it, or is there a combination of opiate and sedatives which has a huge increased risk of overdose because of the sedation side effects. There are other combinations too. Those are the two big ones that we look for, the combinations." Pg. 76

    "I need to know if the patient's been discharged from other pain doctors before they came to me. Very frequently that's the case. In which case why do I want to try that experiment again?:Pg. 80

    "We would expect that depression, anxiety and bipolar disorder would worsen with -- with opioids and we would particularly expect those diagnoses to get worse with high doses." Pg.95

    "30 milligrams is important. 30 milligram oxycodone is the most street-valued narcotic from a prescriptive standpoint arguably. It's the highest dose of unadulterated oxycodone.
    It's extremely popular out on the street because it can be crushed and then snorted or injected. It has the highest per-milligram value. 30-milligram oxycodones are known to be
    the highest risk of single pain medication in that group." Pg. 96

    "In no case really are headaches acceptable diagnoses for the use of opiates" Pg. 98

    "She did have one urine drug screen that was negative for prescribed hydrocodone, but no action was taken on that" Pg. 99

    And it was noted from a behavorial standpoint that she visited the ER frequently for headaches and it was a, quote, common complaint for her, suggesting that she was going there just to
    get narcotics." Pg. 99

    "when a patient presents to me for pain. management, even though that individual may have been receiving narcotics from another doctor it's up to me to be the gatekeeper.So, no, we don't just accept trading one patient to another and maintaining the narcotics." Pg. 100

    Q "Is the prior use of opioids and the fact that a referral is made some indication that it didn't work?   A "It is absolutely an indication that it didn't work" Pg.100

    But in all likelihood there was opioid-induced hyperalgesia going on which would more likely count for some of the legitimate cases where the patients might have been requesting higher opiates. In other words, it was iatrogenic, the doctor was causing it. He was making the pain worse. He was doing harm." Pg. 102

    "But it goes on to say there are expressed concerns regarding the patient presenting to the pharmacy has large rolls of cash. Is always with a different young man. She questioned our monitoring system." Pg. 116

    "In all likelihood her pain is what we call psychosomatic. She may not be making it up, but it still may be a psychosomatic manifestation of suffering and these would be treated with other than opiates. It needs to be treated with a psychiatric foundation and psychiatric counseling modalities." Pg. 118

    "She had significant anxiety and depression. I wanted to talk about the risk factors on this patient for just a moment. She had significant anxiety and depression that resulted in all likelihood from the history of preadolescent sexual abuse...We are unfortunately aware that preadolescent sexual abuse, particularly in women, young girls, is probably one of the major predictive factors for drug abuse. " Pg. 134

    If we're talking about red flags, if we're talking about as a doctor how to best help the patient and not make it worse particularly from a pain management standpoint, we have to identify risks that have to do with emotional, physical or sexual abuse, particularly in women -- also men, but also in women." Pg. 135

    "In this case her history, preadolescent sexual abuse and subsequent anxiety and depression, is consistent with the pain that she complains of. It's a vague pain. It's a vague pain that nothing on physical exam or imaging shows broken. She had an MRI of her low back, it's normal. It's normal. So again, she's suffering. She's suffering from pain as a result of an emotional trauma. And that needs to be identified. Why does that need to be identified? Because opiates are going to make that worse. Again, make that worse" Pg.135

    "My hourly fee is $350 an hour. And for a day of testimony it's $5,000." Pg.158


    Quotes from: United States v CHARLES R. SZYMAN Transcript of Jury Trial  11/16/17  (Part 2)

    "No, that's where -- as I indicated yesterday, it's verydifficult to be a doctor. You have to be a detective. Our universal precautions dictate to some degree that we be detectives. Well, we expect the doctors especially in this area to verify. So to a certain extent we have to find other ways to verify that what the patient says regarding their increased activity is really true. We may have to contact a family member, we may have to contact an employer, we may have to have other types of verification." Pg. 23

    Question from lawyer to King: "When people walk into a doctor's office with the objective -- I'm sorry, with the subjective intent to deceive them and give them a bunch of false information and mislead them, that's obviously going to have a negative impact on that doctor's ability to properly treat that patient. Agreed?"       King's response: "That occurs in about a third of my patients across the board, and the answer is yes." Pg. 49

    Question from lawyer to King: "And your position is if it's not documented it's not true, right?"  King's response: "That's generally the standard of care, yes." Pg. 51

    "Patients, especially patients who are addicted and have substance abuse problems, have a distorted sense of reality. I would never say the patient lied, Counselor. It's just that their perception of things is not correct and as a physician I have to be aware of that." Pg. 56

    "By definition -- by definition of addiction we know that those patients have control issues, cognitive issues and recurrent problems related to acuteness and what we call executive functions. Their memories aren't good. Their recollection is not accurate. Their perception of what happened in the past is just simply not something we can depend on. What we do depend on is the narrative and the objectiveness of the medical chart." But as a physician, as a specialist in the area of addiction medicine and pain medicine and anesthesiology, I know for a fact
    that there's a rewiring of the brain and the individual cannot change that. That's something that occurs that is with them for the long term. And, therefore, as a physician I have to be aware of
    the fact that when I talk to those patients I may not be getting the full situation, I may not be getting the full truth." Pg. 60

    Question from lawyer to King "Right. Your opinion of the standard of care or your opinion about the standard of care leads to people being prosecuted. That's what you're saying."  King's response " It is one of the factors, yes." Question from lawyer to King: "And when people get prosecuted you get to testify and make your $5,000 a day, right?" King's response: "Well, I do get paid for my time, yes. I am primarily a physician. That's where I make the majority of my -- invest the majority of my time and my income." Pg. 64


    Quotes from USA v Dr. Campbell part 1 5/19/21

    "Since 2015 I've been compensated 8 -- well, personally I've been compensated for approximately 126 hours of work at $350 an hour and that -- I think turned out to be somewhere around 42,000. I had staff involved in this case doing secretarial-type work, administrative work, and that was an additional -- I don't know how many hours, but that amounted to about an additional 40 thousand dollars as well." Pgs. 3-4

    "I've done consulting work for many other cases, yes. In 2013, 2014 I was mostly active with the Attorney General's Office in the state of Indiana doing prosecution of pill mill cases and overprescribing. I also participated with the state of Indiana putting together the rules for appropriate opiate prescribing for chronic pain. That morphed into more of an exposure into the federal pursuit of overprescribing. And I have worked over the last I would say six to eight years -- about 90 percent of my time has been involved working with the Department of Justice, the DEA, the FBI, on overprescribing and pill-mill issues across the nation in various states. About 10 or 15 percent of my time -- may not have my math exactly right, but about 10 or 15 percent of my time has been involved in consulting with medical groups who ask me to come in and do an audit of their practice to make sure they're confirming to appropriate opiate guidelines." Pgs. 4-5

    "But chronic pain is different than acute pain. It's treated differently. The physiology is different. The pharmacology is different. Why is it different? It's different because chronic pain is a combination of psychological discomfort as well as what we call physical or somatic discomfort. It is well understood that pain is -- and I'm going to use a term that I'm going to use as time goes on today and perhaps tomorrow. We need you to be aware of it. It's called biopsychosocial. Bio meaning you may have had an injury, perhaps a back operation. Psycho meaning you're going to have psychological consequences as a result of disability or  injury; depression, anxiety, PTSD perhaps depending on whether it was an accident or other things were going on, but you're going to have a preponderance of psychological issues that need to be dealt with in chronic pain. Social. Social circumstances contribute to drug dependency and can present as what we call somatic complaints of back pain or abdominal pain or chronic headaches. Are they real? Yes, they're real, but in cases of psychological and social contributions to pain, opiates are contraindicated they're not recommended, because they cause problems for pain of emotional etiology. So if an individual's homeless or has horrible financial issues or a terrible, stressful life or -- unfortunately one of the things we see in the social end is we see women mostly but men sometimes who have been victims of preadolescent sexual abuse or physical abuse or emotional abuse but particularly preadolescent sexual and physical abuse is a situation that contributes to psychological pain. It's the way that various traumas -- the body tries to cope with that trauma, deal with it over the years, and it expresses itself as a dependency on medicine. And those patients typically have associated PTSD, severe anxiety, and depression, and bipolar disorder. opiates are not indicated for treatment of psychological and social etiology of pain. It makes those things worse." Pgs. 14-15.

    "But, and I'll sort of close on that question by saying that it has been generally estimated that in 80% of the pain associated with chronic pain is psychological. It's a very careful walk controlled substances or opioids are to be chosen for chronic pain because it will make that 80 percent psychological mental health portion worse and the risk benefit ratio will not be to the benefit of the patient." Pg. 15

    "So the first thing we decide is how much is psychological.  So we evaluate the patient, find out how much depression is playing part in their inability to function, their inability to sleep, their inability to go to work, and we would address that in a nonopiate manner. And then we would address any associating anxiety or any other mental health issues." Pg. 16

    "We are well aware that there are certain conditions that are associated with the aberrant use of controlled substances; aberrancy leading to diversion and addiction. In three broad categories here's what they are and this is...first thing we inquire about is the mental health status of the patient..So we look carefully at the mental health end of things. Is PTSD an issue? Is there a problem with a mental health condition that is causing the pain? And we refer to that as psychosomatic pain. It's real to the patient. Patient's not making it up. But it's being caused by a mental health condition. So we call mental health, the mental health condition risk factors in terms of the use of opiates because they shouldn't -- opiates shouldn't be used in mental health conditions if they're really what's causing the pain, so -risk factors of mental health...Second set of risk factors are what we call social or psychosocial. And, again, we need to understand the patient's history and current living conditions to find out if those factors are contributing to the pain. And you might say, well, how can that contradict to the pain? And I will  remind you all that either yourself or perhaps you have children who at some point said, Hey, I don't want to go to school, dad. I don't want to go to school this morning. Why don't you want to go to school, Nick? Because I have really bad stomachache and I can't go today. Well, what else is going on at school? Well, you know, there's a bully at school who's been picking on me. And so we understand sometimes how social conditions can create what we call somatic pain complaints in the patient. Now, whether we have a kid who doesn't want to go to school, that's one thing, but the same thing exists in the adult population if there has been a traumatic event or series of traumatic events that is causing you to try to avoid life. And avoiding life your brain will interpret that as a chronic pain; head pain, chest pain, abdominal pain, pelvic pain, muscle pain. And we have to identify that, so this second series of risk factors we look for are the social or sometimes called psychosocial separate from the mental health. The psychosocial conditions that are contributing to suffering in that patient. We have to differentiate suffering from --from pain. That's separate discussion, but we have to understand why the patient is suffering so we look at the social issues. Pgs. 26-28

    "But you see what you have to understand is that it's a combination of guidelines and protocols put forth by our professional organizations by the states, by the government, and by peer-reviewed publications. Those are the four main areas that we have input in terms of what works, what doesn't work, and how to properly use opiates. Those are the four things that come together that ultimately then define and practice what is the standard of care. So yes they may have started as guidelines, but they were contributory to defining what the standards were in practice." Pg. 32

    "AMDJ guidelines from Washington were published I think it was 2004. I don't remember the exact dates on those, but those have been fundamental in terms of helping us define the guidelines as well."

    Lawyer: "Do you find all those useful in defining the standard of care?"  King: "I do." Lawyer: "Okay. And are you going to base your opinions we talk about today on those standards of care?" King: "Yes." Pg.33-34

    "It's (RSD/CRPS) what we call diagnosis of exclusion. So we look at all other things before we decide that we're going to assign that diagnosis to a patient. It's very difficult to treat. We don't have any way of curing it. Opiates are not the way to treat it." Pg. 39

    "Polypharmacy in this condition is the combination of an opiate, combined with a benzo., in combo with Soma, which is an addictive muscle relaxant. I'll tell you what it's known as on the street. The street knows it as the Holy Trinity. Why is it street popular? Why has it got the name the Holy Trinity? Because it's highly addictive. It's very dangerous. It disproportionately contributes to respiratory depression and overdose death. And it is -- it is not medically indicated." Pg. 41

    "The polypharmacy combination of the Holy Trinity and then there was a second polypharmacy combination I was going to bring to note that we call a prescription speedball which is combination narcotic and stimulant. It's also appropriate based on standard of care not to prescribe polypharmacy combinations that we know are going to stimulate the probability or possibility of addiction. So these are recognized combinations that since the -- I would say the mid-2000s, maybe earlier than that, we were aware that that should not be prescribed to patients because they're psychiatric medications. They are prone to abuse and street popularity and induce addiction." Pg. 48

    "And by the way, this should occur with every visit going back to universal precaution on every follow-up visit the patient is supposed to have interrogation and documentation." Pg. 56

    "Buprenorphine is a -- what we call an agonist-antagonist. It is a type of opiate, but it's used for treatment of addiction for various reasons and -- well, that's what it is." Pg. 57

    King: "Patient complains two out of ten cervical pain and four out of ten low back pain today with pain medication. Lawyer: "Are those pain scores significant?" King: "Those pain scores are pretty dog on low. We generally feel -- just frame of reference, if somebody's pain score is somewhere at three to four out of ten or below on a scale of one to ten, if it's a VSC, visual analogue score, of three to four out of ten, that's usually a pain score where the patient either does not need pain medications or sophisticated treatment or is at a point where if they're on opioids, they can start to be weaned. Because, again, the end point is function, so if you have a VAS point of two out of ten and four out of ten, that's excellent, and it means if the patient's on opioids you can start to wean at that point." Pg. 63

    Lawyer: "Was there any indication that pain and function improved. as a result of the opioid treatment?"  King: "There was no indication that pain and function improved. The pain score remained high. Patient continued to be unemployed and/or disabled." Lawyer: "And so were the drugs that Dr. Campbell, Mark Dyer, and Dawn Antle gave to Brandon McDonald from December 6, 2012 to April 19, 2014, one, for a legitimate medical purpose?" King: "No they were not." Lawyer: "And written within the usual course of professional practice?" King: "They were not." Pg. 64

     "..left thigh pain secondary to tumor. It also indicates an ongoing pain level six out of ten which is quite significant. If the opiate s had worked in the past, I would expect her to have better pain control. That really tells us she probably failed -- not probably. She did fail past opiate therapy so why do it again." 

    King: "It says patient became angry and started yelling," Lawyer: "Is that a red flag or is this someone truly in pain? " King: "So this is helpful in terms of her diagnosis. when you have an individual who's expressing emotion like this that tends to reinforce the diagnosis of an emotional pain; a pain secondary to psychological suffering. The patient really sees it as real, but the patient really should not have narcotics because opiates...also not indicated for the treatment of psychological pain. She needs to be referred to a Psychiatrist. She needs to be counseled with regard to mental illness issues and with regard to dependency issues. So yes this is an emotional pain. It's what we call psychosomatic pain. Real. But not treated with opiates. " Pg. 74

    "So -- so the benzos are an absolute no-go when you have chronic methadone as part of the regimen." Pg. 84

    "Typically the patients for the robotic partial nephrectomy that we see here would be kept in the hospital assuming no complications for maybe a day or two and then sent home. So they -- and they would not be in need of more than, you know, maybe three days of as-needed opiates for pain relief." Pg. 85

    "There was no indication of improvement of pain or function. She remained unemployed and disabled..." Pg. 87

    "Anything above 90 to a hundred is what we call the region of extreme concern. It's very high risk. And so hers were up in that category. So any time you see a morphine equivalence greater than 90 to a hundred, that's a high-risk situation." Pg. 100

    "If an objective diagnosis is not established, there's no rationale to prescribe controlled substances, therefore anything prescribed would be outside the usual course of medical purpose. " Pg. 100

    King: "discharged as a patient at Dr. Christopher Nelson's office over medication issues. Totally out of medications now." Lawyer: "Is that a red flag?" King: "That's a major red flag. That's a full stop. That means that we've got a history here of aberrant activity..." Pg. 102 

    "so she's up in the what does that make it 140 morphine equivalence category which is above that 90 to a hundred milligram sort of ceiling dose concern that I referenced earlier. When somebody goes above that concern -- here is a figure for you to keep in mind -- the increase in overdose death increases by about ten times  So people who are at that MEQ dose or higher have ten times more increase in overdose death just associated with that dose." Pg. 108

    "Phentermine again is an amphetamine-like stimulant. It works sometimes well for weight loss for short time frames, but when it's combined with an opiate, it's called a prescription speedball. You may have heard of a speedball before. It's terribly addictive. The true speedball is sort of the ultimate stimulant which is cocaine with the ultimate opiate which is heroin, so a speedball is cocaine and heroin." Pg. 109

    "So first one is major depressive disorder, recurrent and severe. Number two is somatization disorder. Somatization -- somatization for purposes of our discussion is psychosomatic pain. It's pain that doesn't have an origin and tissue destruction. It's a representation of emotional suffering. What is the emotional. So emotional suffering, what does that mean? In her case it indicates patient is reporting childhood abuse. And as I mentioned to you earlier, preadolescent sexual abuse is one of the biggest predictors of opiate misuse and addiction." Pg. 111

    "She's been put at extremely high risk because the real diagnosis is emotional pain due to mental illness and her inability to cope with -- with problems related to her preadolescence and she has PTSD depression and anxiety. Those are pretty tell-tale for a unfortunate young woman for someone who suffered physical and emotional abuse as a young child. This should be recognized by any physician practicing pain medicine. It's a major red flag." Pg. 111

    "Well, 80 to 90 percent of the work I do is with federal agencies....At the moment it's certainly a full-time job, yes." Pg. 210-213

    Lawyer: "A full-time consultant reviewing practices using this type of chronology and jumping on the witness stand and testifying exclusively for state and federal enforcement agencies?" King: "Well, the majority of my work has come from federal sources, but I'll also consult with attorney groups, insurance groups, and medical practices." Lawyer: "But you've never sat on the stand and testified on behalf of an actual practicing physician in a federal or state case, correct?" King: "That is correct."


    Quotes from USA v Dr. Campbell part 2  5/20/21 

    "We have found -- we have not found any that opiates improve function in the case of chronic pain." Pg 26

    "The addiction and mental illness needs to be optimized and controlled before the pain can be addressed and we understand that because psychological contradictions to pain are overwhelming and if we don't address the psychological and addiction concerns first, pain's not going to be controlled." Pg. 40


    Quotes from USA v Dr. Bauer  part 1  7/12/21

    "There's a sort of a part two to that, in the sense that back -- well, I've spent a lot of time with the Attorney General's Office, State of Indiana, where they asked me to come in back in the early part of 2012, 2013 to assist in the states putting together of appropriate opioid protocols. Most of the state boards did, Ohio did it as well. But they asked me to participate on -- on the committee for Indiana. As part of that, I also worked with the Attorney General's Office on specific cases. Cases that they brought, were bringing to the medical board for overprescribing or pill mill type operations. And I guess that's a long way of saying as I worked there, and I had a little niche place in the back office, the investigators would sometimes bring me cases that had not actually been brought to maturity, but ones that they were concerned about and would ask me my opinions. So I did a fair amount of consulting in that regard on cases that the state was not sure whether it merited proceeding to medical board action." ~Dr. Tim King, Pg. 51

    "I've consulted in criminal prosecutions, Civil suits (both in Federal and state court)." ~Dr. Tim King. Pg. 51

    "Well, in the business you're referring to, so the jury understands, is my consulting practice. In the beginning, and by in the beginning I mean around 2012 or so, or prior to 2012 I had been involved in offering my expertise to the federal government from time to time." ~Dr. Tim King Pg. 52

    "So the name of my consulting organization was at that time, and still is, Midwest Medical Legal Consultants, and that's a corporation. Yes, I do have employees. I have -- I have two nurses, two registered nurses and an office manager. The two registered nurses are -- well, one registered nurse is my wife. The other registered nurse is my daughter, who The third employee, the office director, is my daughter as well." ~Dr. Tim King Pg. 55


    Quotes from USA v Dr. Bauer  part 2  7/13/21

    Being updated

  • US could loosen some restrictions on prescribing opioids

    US could loosen some restrictions on prescribing opioids

    CDC considers rolling back limits on which doses can be prescribed and for how many days in cases of acute pain

    The US could see loosened guidance around prescribing opioids, as the US Centers for Disease Control and Prevention (CDC) considers relaxing some of its guidelines in a move that could signal a new direction for managing chronic pain.

    The CDC last Thursday released proposed changes to its guidance on prescribing opioids, rolling back limits on which doses can be prescribed and for how many days in cases of acute pain.

    The agency created rules in 2016 to reduce prescriptions that were fueling the opioid overdose epidemic. But as rules like these were put in place, opioid overdose deaths rose instead of falling.

    New laws in several states were drafted to codify the restrictions, and some insurers began basing their coverage of medications on the guidance.

    The sweeping actions cut off medications for some patients battling chronic pain and substance disorders, sometimes without the option of tapering down the medications or undergoing substance dependence treatment.

    As the sources of medications dried up, some patients turned to illicit substances like heroin and fentanyl.

    “You’re inadvertently driving people to an illicit supply if they’re being cut off,” said Kate Nicholson, executive director of the National Pain Advocacy Center. “The street supply is so tainted that you’re really pushing people to a very dangerous thing.”

    Fatal overdoses rose from 63,000 in 2016 to more than 100,000 last year, many of them driven by the powerful synthetic opioid fentanyl. Deaths from fentanyl have doubled in the US in the past two years – but teens in particular have been hit hard by fentanyl overdoses, with the death rate tripling in that time.

    Yet harm reduction groups have struggled to access affordable naloxone, the drug that reverses opioid overdoses. And only one state, Arizona, had enough naloxone in 2017 to prevent a majority of overdose deaths, according to a study published in the Lancet on Thursday.

    ‘It was being used against me’

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