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2023 Recap and what's to come in 2024 

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Brandeis Rally Information

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Improving Access to Care for Patients Taking Opioids for Chronic Pain: Recommendations from a Modified Delphi Panel in Michigan

Researchers out of University of Michigan are studying lack of access to care for CPP's who take opioids. 

Link to full study 

Abstract:

Purpose: About 5–8 million US patients take long-term opioid therapy for chronic pain. In the context of policies and guidelines instituted to reduce inappropriate opioid prescribing, abrupt discontinuations in opioid prescriptions have increased and many primary care clinics will not prescribe opioids for new patients, reducing access to care. This may result in uncontrolled pain and other negative outcomes, such as transition to illicit opioids. The objective of this study was to generate policy, intervention, and research recommendations to improve access to care for these patients.

Participants and Methods: We conducted a RAND/UCLA Modified Delphi, consisting of workshops, background videos and reading materials, and moderated web-based panel discussions held September 2020–January 2021. The panel consisted of 24 individuals from across Michigan, identified via expert nomination and snowball recruitment, including clinical providers, health science researchers, state-level policymakers and regulators, care coordination experts, patient advocates, payor representatives, and community and public health experts. The panel proposed intervention, policy, and research recommendations, scored the feasibility, impact, and importance of each on a 9-point scale, and ranked all recommendations by implementation priority.

Results: The panel produced 11 final recommendations across three themes: reimbursement reform, provider education, and reducing racial inequities in care. The 3 reimbursement-focused recommendations were highest ranked (theme average = 4.2/11), including the two top-ranked recommendations: increasing reimbursement for time needed to treat complex chronic pain (ranked #1/11) and bundling payment for multimodal pain care (#2/11). Four provider education recommendations ranked slightly lower (theme average = 6.2/11) and included clarifying the spectrum of opioid dependence and training providers on multimodal treatments. Four recommendations addressed racial inequities (theme average = 7.2/11), such as standardizing pain management protocols to reduce treatment disparities. Conclusion: Panelists indicated reimbursement should incentivize traditionally lower-paying evidence-based pain care, but multiple strategies may be needed to meaningfully expand access

The authors held a panel where they discussed possible solutions. They plan to reconvene in the coming months.

Video #1

Video #2

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Gabapentin lawsuits: Please don't email or call Claudia, the information is in the following links:

WHAT IS GABAPENTIN?

Gabapentin (Neurontin) is a seizure medication that has been promoted for off-label use as an opioid sparing medication. Interestingly, the updated draft of the CDC Guidelines mentions Gabapentin 30 times. 30. Pfizer, maker of this drug, is a a huge donor to CDC Foundation. Is that why they mention it so often in the new guidelines? Who knows? 

HARMS FROM GABAPENTIN (NEURONTIN)

Read Dr. Josh Bloom's article "The Devil You Know - Neurontin's Massive Flop as an Opioid Alternative" for more information. 

"Wanna hear something sickening? Neurontin, a drug developed for epilepsy and used off-label for neuropathic pain, had its sales grow 250% between 2004 and 2019. Why? We don't have 250% more epileptics. No, it's because the drug is being forced down the throats of people who can no longer get sufficient pain relief. The result? Abuse and also more overdose deaths. Just another chapter in our psychotic war against legitimate opioid drugs and the people who need them."

CLAUDIA'S TIK TOK VIDEOS ABOUT GAPABENTIN (NEURONTIN)

Check out the other Tik Toks on our new main Tik Tok account thedoctorpatientforum1

Our old account is Claudia A. Merandi

LAWSUITS FOR THOSE HARMED BY GABAPENTIN (NEURONTIN)

Please don't email or call Claudia regarding the lawsuits.

The information is in the following links: 

"Gabapentin and Neurontin deaths and injuries dramatically increased recently. Contact us to report your injuries and get help. Free case evaluation. Fill out the form on this page or call 424-245-5505. You don’t pay for attorney fees until we win.

If you have lost a loved one or you have suffered from breathing or heart problems or other issues like memory loss and blurry vision, contact us to report exactly what has happened. Free case evaluation.

In a recent article published May 13, 2022 by the Center for Disease Prevention,  “Trends in Gabapentin Detection and Involvement in Drug Overdose Deaths — 23 States and the District of Columbia, 2019–2020“, research scientists reported that there are many serious new developments in serious side effects and death resulting from gabapentin use. Contact us for a free case evaluation."

HAS THERE EVER BEEN OTHER LAWSUITS ABOUT GABAPENTIN?

Yes, in 2004 Pfizer agreed to $190 million settlement over generic Neurontin.

Interestingly, this lawsuit was used to create the Attorney Generals' prescriber and consumer education grant. This grant was then used to create Pharmed Out by PROP member, anti-opioid zealot, and expert witness profiteer Adrianne Fugh-Berman. 

Dr. Jeffrey Singer debated Dr. Fugh-Berman in June 2022. Read about the debate in this article called "A Surgeon and a Non-Practicing Anti-Opioid Zealot Walk Into a Bar: The Singer and the Fugh-Berman Debate." Then, oddly enough, PROP declared Fugh-Berman the winner when she wasn't. The head of the debate, Gene Epstein, wasn't thrilled and tweeted about it.

Another interesting tidbit about Fugh-Berman, is she was asked to testify at the McGaskill hearing about her first investigation into opioids. Here, Fugh-Berman didn't declare a COI of being a paid expert witness in litigation and told McGaskill that to solve the opioid crisis, they needed to investigate "fake pain advocacy orgs" and their ties to opioid pharma. They did. Many of the lawyers who donated to McGaskill turned around and used her investigation to participate in opioid litigation. The investigation was key in opioid litigation, and many of her PROP colleagues benefitted financially such as Andrew Kolodny and Anna Lembke. But, they claim anyone who stands up for CPP's must be industry funded. What a scam.

Now let's watch Fugh-Berman push back when Dr. Stefan Kertesz presented his study on suicides due to cutting off opioids from CPP's.

WILL THERE BE A PODCAST ABOUT GABAPENTIN?

Yes, and we plan to interview Dr. Josh Bloom along with some other experts. We will post it here when it is published. Check out the other podcasts by The Doctor Patient Forum. 

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WHAT IS THE FDA WARNING ABOUT BUPRENORPHINE PRODUCTS (SUBOXONE/SUBUTEX)?

In January of 2022 the FDA released a warning about buprenorphine products being associated with dental decay. FDA also gave further explanation about this warning here.

Some quotes from the FDA warning:

The U.S. Food and Drug Administration (FDA) is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.

Some cases reported dental problems occurring as soon as 2 weeks after treatment began, with the median time to diagnosis being approximately 2 years after starting treatment. Many cases were reported by health care professionals and provided documentation of extensive dental adverse events.

CAN I SEE THE REPORTS OF ADVERSE EVENTS OTHER PEOPLE HAVE MADE?

Yes! The FDA has a website called FAERS (FDA's Adverse Event Reporting System). Anyone can search reports of adverse events on this website.

Here is are some FAQ's about FAERS. 

WHAT DO I DO IF I HAVE A SUBOXONE RELATED DENTAL INJURY?

Instead of e-mailing Claudia or Bev your information about your dental injury, please take the following steps:

1. Call the law firm's call center -  213-212-2202

2. Fill out the form on this website about dental issues and Suboxone - 

3. Report your dental injury on the FDA's MedWatch website.

"MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as:

  • Prescription and over-the-counter medicines
  • Biologics such as blood components, blood/plasma derivatives and gene therapies.
  • Medical devices such as hearing aids breast pumps, and pacemakers.
  • Combination products such as pre-filled drug syringe, metered-dose inhalers and nasal spray.
  • Special nutritional products such as dietary supplements, medical foods and infant  formulas.
  • Cosmetics such as moisturizers, makeup, shampoos, hair dyes and tattoos.
  • Food such as beverages and ingredients added to foods."

IS THERE A LAWSUIT ABOUT DENTAL INJURY FROM SUBOXONE (BUPRENORPHINE)?

WHAT DOES ANDREW KOLODNY AND PROP HAVE TO SAY ABOUT THIS ISSUE?

Kat Marriot, the Executive Director of PROP had this to say about Suboxone and dental injuries:

PETITION FROM ADDICTION ORGS FOR FDA TO RETRACT THE WARNING

Interestingly, about ten addiction organizations (many that take money from Indivior) quickly petitioned the FDA to retract the warning. Their point is that Suboxone saves lives of those with Opioid Use Disorder, and this warning can discourage people from taking the medication. It's ironic because these same organizations are the ones helping to sue Purdue and other pharma companies for hiding possible negative side effects of opioids for pain. I suspect many of these orgs will also be getting some of the billions in settlement funds from the multi district litigation against pharma.

We 100% understand that this medication saves lives of those with OUD. Does that mean they don't have a right to know what can happen to their teeth? Dental care is extremely expensive, and can cost tens of thousands of dollars. Who can afford that? People with addiction have a right to know the possible side effects of this medication. The other issue is Suboxone/Subutex is being pushed on people in pain. It absolutely works for some people, and we support its use as an option. Unfortunately, it's often not given as AN option it's given as THE ONLY option even to patients who are stable on full agonist opioids. Don't CPP's have a right to know what can happen to their teeth especially if they're told their options are Suboxone or nothing? 

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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."

 

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As many of you know, the 2016 CDC Opioid Guidelines have caused harm to many. Whether the guidelines themselves are the problem or if they have just been misapplied has been widely discussed by experts. In July 2021, the CDC released their draft of the updated opioid guidelines. We explained it all in detail in our newsletter. If you haven't had a chance to read it, please do. It helps put all of this in context. The new draft of the guidelines was published last week. Here are two very important links:

Word and pdf of this information

Some CPP advocates created this Community Sign-On Letter for anyone who'd like to sign. Please sign this as well as submitting your own comment on the docket.

BACKGROUND OF THE CDC GUIDELINES:
On February 10, 2022 the CDC published a draft of their updated/expanded Opioid Guidelines. Read our July and February newsletters for an in depth explanation of the 2016 Guidelines, and the all-day meeting CDC held in July to discuss their original draft for the updated/expanded guidelines.
WHO SHOULD COMMENT:
  • All Chronic Pain Patients (CPP's) should comment.
  • All loved ones (family and friends) of a CPP should comment. They should include the following information:
    • What it's like for them to watch you suffer needlessly.
    • If your pain is currently adequately treated, they should write what you're able to do and how you're able to function due to medication.
    • If your pain was adequately treated and has been tapered or stopped, they should write how your life has changed since the medication has been taken away. Emphasize function. What things were you able to participate in before your medication was stopped? What things are you unable to do now?
WHERE TO COMMENT:
  • CDC is accepting comments here on the draft of the updated/expanded Guidelines until April 11, 2022. You can also read comments that are already posted.
  • ***IMPORTANT INFORMATION - The link for leaving comments about the draft of the guidelines has been broken off and on. If you find the link is broken when you're trying to leave a comment, please contact Arlene Greenspan at 770-488-4696 or e-mail her at opioids@cdc.gov
WHY COMMENT:
  • We can't express strongly enough how important it is that you comment. Every single person who has been devastated by these Guidelines needs to post a comment.
  • We also suggest that you send a copy of your comments to your local legislators. They need to hear from their constituents about how devastating the 2016 Guidelines have been and how your lives have been harmed.
  • CDC will review ALL comments, and based on what they see will update the draft accordingly. The new draft will come out by the end of 2022 and will replace the 2016 Guidelines.
RULES FOR COMMENTING:

****We list some suggestions for you, but please don't use these suggestions word for word. If you do, there is a good chance the CDC will remove your comments.****

The CDC lists the "commenter's checklist." The checklist includes the following:

"Tips for Submitting Effective Comments

Overview

A comment can express simple support or dissent for a regulatory action. However, a constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision making.

These tips are meant to help the public submit comments that have an impact and help agency policy makers improve federal regulations.

Summary

  • Read and understand the regulatory document you are commenting on
  • Feel free to reach out to the agency with questions
  • Be concise but support your claims
  • Base your justification on sound reasoning, scientific evidence, and/or how you will be impacted
  • Address trade-offs and opposing views in your comment
  • There is no minimum or maximum length for an effective comment
  • The comment process is not a vote – one well supported comment is often more influential than a thousand form letters

Detailed Recommendations

  1. Comment periods close at 11:59 eastern time on the date comments are due - begin work well before the deadline.
  2. Attempt to fully understand each issue; if you have questions or do not understand a part of the regulatory document, you may ask for help from the agency contact listed in the document.

    Note: Although the agency contact can answer your questions about the document's meaning, official comments must be submitted through the comment form.
  3. Clearly identify the issues within the regulatory action on which you are commenting. If you are commenting on a particular word, phrase or sentence, provide the page number, column, and paragraph citation from the federal register document.
  4. If a rule raises many issues, do not feel obligated to comment on every one – select those issues that concern and affect you the most and/or you understand the best.
  5. Agencies often ask specific questions or raise issues in rulemaking proposals on subjects where they are actively looking for more information. While the agency will still accept comments on any part of the proposed regulation, please keep these questions and issues in mind while formulating your comment.
  6. Although agencies receive and appreciate all comments, constructive comments (either positive or negative) are the most likely to have an influence.
  7. If you disagree with a proposed action, suggest an alternative (including not regulating at all) and include an explanation and/or analysis of how the alternative might meet the same objective or be more effective.
  8. The comment process is not a vote. The government is attempting to formulate the best policy, so when crafting a comment it is important that you adequately explain the reasoning behind your position.
  9. Identify credentials and experience that may distinguish your comments from others. If you are commenting in an area in which you have relevant personal or professional experience (i.e., scientist, attorney, fisherman, businessman, etc.) say so.
  10. Agency reviewers look for sound science and reasoning in the comments they receive. When possible, support your comment with substantive data, facts, and/or expert opinions. You may also provide personal experience in your comment, as may be appropriate. By supporting your arguments well you are more likely to influence the agency decision making.
  11. Consider including examples of how the proposed rule would impact you negatively or positively.
  12. Comments on the economic effects of rules that include quantitative and qualitative data are especially helpful.
  13. Include the pros and cons and trade-offs of your position and explain them. Your position could consider other points of view, and respond to them with facts and sound reasoning.
  14. If you are uploading more than one attachment to the comment web form, it is recommend that you use the following file titles:
    • Attachment1_<insert title of document>
    • Attachment2_<insert title of document>
    • Attachment3_<insert title of document>
    This standardized file naming convention will help agency reviewers distinguish your submitted attachments and aid in the comment review process.
  15. Keep a copy of your comment in a separate file – this practice helps ensure that you will not lose your comment if you have a problem submitting it using the Regulations.gov web form.

Posted Comments

After submission, your comment will be processed by the agency and posted to Regulations.gov. At times, an agency may choose not to post a submitted comment. Reasons for not posting the comment can include:

  • The comment is part of a mass submission campaign or is a duplicate.
  • The comment is incomplete.
  • The comment is not related to the regulation.
  • The comment has been identified as spam.
  • The comment contains Personally Identifiable Information (PII) data.
  • The comment contains profanity or other inappropriate language.
  • The submitter requested the comment not be posted.

Form Letters

Organizations often encourage their members to submit form letters designed to address issues common to their membership. Organizations including industry associations, labor unions, and conservation groups sometimes use form letters to voice their opposition or support of a proposed rulemaking. Many in the public mistakenly believe that their submitted form letter constitutes a "vote" regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence rather than a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters.

* Throughout this document, the term "Comment" is used in place of the more technically accurate term "Public Submission" in order to make the recommendations easier to read and understand.

Disclaimer: This document is intended to serve as a guide; it is not intended and should not be considered as legal advice. Please seek counsel from a lawyer if you have legal questions or concerns."

WHAT TO SAY IN COMMENT:

Sometimes it's hard to know what to say. We created some basic comment ideas. 

In case you would like some suggestions on what to say in your comments, here are some ideas:

  • Tell your story and how you've been affected by the 2016 CDC Guidelines.
    • You can use your name or remain anonymous.
    • Mention your state and if your state has laws based on the CDC Guidelines.
    • Briefly describe how you've been hurt by the Guidelines.
    • Be sure to emphasize not just pain relief but also address function. What were/are you able to do with adequate pain medication that you weren't/aren't able to do without it.

  • Remove ALL mention of MME (Milligrams of Morphine Equivalent)including in the supporting text.

  • Remove ALL mention of limit of days for prescription for acute pain including in the supporting text.
    • Although they removed mention of 3, 5, or 7 day limits in the actual Guidelines, the supporting text still has "a few days" and "7 days" mentioned. This needs to be removed.

  • Fund and execute a plan for how to de-implement the 2016 CDC Guidelines.
    • Although CDC claims these were "just guidelines" arbitrary limits such as MME limits and 3,5, or 7 day limits are an issue because:
      • Many state laws have been created based on them.
      • They are worked into EHR (Electronic Health Records).
      • Risk score algorithms such as NarxCare use them.
      • CDC funded an extensive implementation plan for them.
      • DEA also uses risk scores to flag doctors who "prescribe outside of the CDC Guidelines."

  • The Guidelines need to be redacted and redone due to bias and conflicts of interest (COI's).

  • Pain is not one condition and they need to mention there are MANY very painful conditions that might require opioids.
    • Exclusions didn't work in 2016 and won't work now.
    • They excluded "cancer pain" in 2016 Guidelines yet cancer patients have been affected.
    • They added Sickle Cell Disease as an exclusion in these Guidelines (which is good since SCD patients have been horribly affected by the 2016 Guideline), but they also need to mention there are many painful diseases and conditions. Just saying "palliative care" patients are exempt won't help anyone. It didn't help in the 2016 Guidelines.
    • There is no scientific basis for the distinction of cancer and non-cancer pain.
    • Mentioning some conditions and not others leads to a lack of individualized care.

OTHER ARTICLES ABOUT  THE UPDATED/EXPANDED CDC GUIDELINES

Many media outlets covered this story. Our favorite is from Josh Bloom "Panic in PROPville."

Here is an article from Pain News Network called "Why CDC Dropped One-Size-Fits-All Approach to Pain Care":

By Pat Anson, PNN Editor

The reaction from patients, advocates and the medical community to a revised draft of the CDC’s opioid guideline has largely been positive, with many cheering the flexibility it gives doctors in deciding whether to prescribe opioids for pain.  

Although voluntary and only intended for primary care physicians, the original 2016 guideline’s dose limits became hard thresholds for doctors in all specialties, who feared scrutiny from regulators and law enforcement if they didn’t follow them. The revised draft still recommends caution when prescribing opioids, but emphasizes that physicians should use their own judgement.

“Treating pain is complex. There are a variety of factors at play. And we know that patients respond differently to different types of pain. We tried to incorporate that nuance so that we’re not coming out with something that’s a one-size-fits-all. It really needs to be individualized and flexible,” said Christopher Jones, PharmD, Acting Director of the CDC’s National Center for Injury Prevention and Control.”

People who’ve been closely following the guideline process were surprised at how extensive the changes are. At a July 2021 public meeting, an independent panel advising the CDC expressed alarm that the agency seemed intent on keeping a recommendation that opioid doses be limited to no more than 90 morphine milligram equivalents (MME) per day.

In the last six months, that dose threshold was taken out of the revised draft, which was published Thursday in the Federal Register.

“It was exciting to open up the draft and see a significant pivot,” said David Dickerson, MD, who chairs the American Society of Anesthesiologists’ Committee on Pain Medicine. “I think the CDC authors have acknowledged that they wanted to do it different this time.”

Dickerson was not only pleased to see the 90 MME threshold go away, but a stronger focus on the many different types of pain, whether its temporary acute pain from surgery or chronic pain from a disabling, incurable disease.  

“I think the text of this manuscript is really well done in its draft form right now. When I read through it, it was a great refresher and highlighted some studies that perhaps I had missed,” Dickerson told PNN. “They are instructive, they’re specific, but they also have an intentional vagueness to them to allow for clinicians to practice medicine.”

Importantly, the guideline also makes clear that it shouldn’t be used by third parties to dictate how pain should be treated.

“This voluntary clinical practice guideline provides recommendations only and is intended to be flexible to support, not supplant, clinical judgment and individualized, person-centered decision-making. This clinical practice guideline should not be applied as inflexible standards of care across patient populations by healthcare professionals, health systems, pharmacies, third-party payers, or state, local, and federal organizations or entities.”

“States and insurers have turned the guideline into laws and unbending regulations, preventing physicians from treating patients as individuals with specific needs,” Bobby Mukkamala, MD, Chair of the American Medical Association’s Board of Trustees, said in a statement. “The list of misapplications of the 2016 guideline is long, and its impact has been tremendous harm.

“The CDC’s new draft guideline — if followed by policymakers, health insurance companies and pharmacy chains — provides a path to remove arbitrary prescribing thresholds, restore balance and support comprehensive, compassionate care.”

Nearly 40 states have codified the 2016 guideline in some way, often by limiting the number of opioid pills that can be dispensed for an initial prescription to seven days’ supply or less.  Dickerson hopes those states will review and revise their laws and regulations to better reflect what the CDC recommends in its revised draft – that enough opioids be prescribed for “the expected duration of pain.”

“We should right-size our care for the individual patient and be procedure specific. Before it was one-size-fits-all, three to seven days’ (supply),” Dickerson said.  

He also thinks the Department of Justice (DOJ) and Drug Enforcement Administration (DEA) should reconsider their aggressive prosecution of doctors for prescribing high doses.

“The work that the DOJ and DEA is doing, I want to believe is done in good intent,” he said. “I think that many of their cases will look at the prescriptions or the doses, but they might not look at the context for why the patient was receiving that care or why they were receiving those medicines.”   

The CDC is not expected to finalize its draft guideline until late this year. You can read the guideline and leave an online comment in the Federal Register. Comments must be received by April 11.

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"We are taking on this fight for you. I've heard your voice and I've put it into the briefs we submitted." ~Atty Ron Chapman

We posted an article last week about the Supreme Court case coming up on March 1, 2022. On Jan 4, Claudia interviewed Ron Chapman, who submitted an Amicus Brief in support of the doctors in this case.  Ron broke it down for us explaining what this means for CPP's and doctors. Listen to the interview to find out what Ron thinks the best and worst case scenarios are depending on the outcome of this hearing.

Summary of the issue

  • Under the Controlled Substance Act (CSA), the criminal standard for prescribing says a physician can't prescribe outside the course of professional practice other than for a legitimate medical purpose, When a doctor elects to prescribe a medication, he needs to make sure he establishes a physician patient relationship and that the prescription is for a legitimate medical need. That should be the extent of the discussion. Courts should not debate about whether it's the right or effective treatment. All the court should ask is if the doctor was acting like a doctor and if he was, then it should be done, acquitted. No conviction.
  • Over the last ten years the federal government has decided to crack down on opioids. They took out pill mills because there were bad doctors. So they hired a bunch of prosecutors and DEA agents, and they started going after these doctors. Once the government ran out of nails (doctors) to hammer and already had all these hammers (DEA agents/prosecutors), it needed more nails to go after. So, they started asking judges and juries to decide closer and closer calls in the practice of medicine, so more doctors would be caught up in its net. This started around 2011.They hired experts to get on the stand and say "here is what the standard is, and if you don't do what I think you should do then you're committing a crime." They got on the witness stand and started spouting their theories of what doctors should and shouldn't do.
  • In 2016 the federal government decided to take these theories of expert witnesses and they codified them in the CDC Guidelines. Now federal courts are using the Guidelines to convict physicians. The problem is there is no consensus on how a physician should prescribe, it's patient specific and can't be reduced to these ideas. The idea that it can is nonsense.

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We at The Doctor Patient Forum talk often about the litigation narrative. What does this mean? It's what we think is their end-game. The reason they've purposely lied. It's all about money. In my opinion it's the entire purpose of the CDC Guidelines. They basically tried to come up with the next big win fashioned after their tobacco settlement. They put this in motion probably about 15 or so years ago. We will write more about this in other articles. The purpose of this article is to report on the thousands of opioid litigation cases across the country. We will keep a running list under this article of rulings of the trials, and up-to-date decisions.

Check here for the most up to date information regarding opioid litigation and settlement funds.

Connecticut Case Against Purdue

In January of 2019 Connecticut Judge dismissed opioid lawsuits against Purdue, and 24 other defendants. This ruling applied to four cases that were consolidated.  "Judge Thomas Moukawsher in Connecticut ruled against 37 cities and towns within the state that brought lawsuits against pharmaceutical companies accused of fueling the opioid crisis in the U.S."

According to this article, the judge ruled "the lawsuits were not allowed because they were not filed as government actions authorized by state public interest laws."

Judge In North Dakota Tossed Out Lawsuits Against Purdue Pharma

In May of 2019, a ND judge threw out lawsuits against Purdue.

Here is a pdf of the judge's ruling.

The Attorney General mentioned he intends to appeal this decision.

Johnson and Johnson in Oklahoma

In 2019 an Oklahoma court found Johnson and Johnson guilty of fueling the opioid crisis. They were found guilty under a public nuisance lawsuit. They were to pay $572,000,000. This was the trial where Koldony and Mendell both testified. Andrew Kolodny was rumored to have been paid at least $500,000 as an "expert" witness. Interestingly, Kolodny had to revise conflict of interest statements when submitting articles for publication, because somehow he didn't think being paid in litigation was a conflict of interest. On November 9, 2021, the Oklahoma Supreme Court reversed the ruling against J&J. This is a huge win. Here is a copy of the actual ruling by the judge. I'll pull out a quote:

"This court will not extend Oklahoma public nuisance law to the manufacturing, marketing and selling of prescription opioids...Extending public nuisance law to the manufacturing, marketing and selling of products-in this case, opioids-would allow consumers to convert almost every products liability action into public nuisance claim."

California Judge Dismisses Cases: 

On November 9, 2021 a California judge dismissed cases against Endo, Teva USA, Caphalon, AbbVie, and Johnson & Johnson. Read our article explaining it in detail. We included all the information and links you need, including the judge's 42-page ruling. This was another win for the pain community. The best part about this ruling was when the judge commented specifically on Lembke's testimony:

"Dr. (Anna) Lembke testified that one in four patients prescribed opioids would become addicted. As Defendants point out, the studies relied upon by Dr. Lembke for that conclusion are inadequate to support  it. The more reliable data would suggest less than 5%, rather than 25%. Under either number, addiction based solely on the patient having been prescribed opioids does not occur in "most of these patients." 

Federal Jury Holds Pharmacies Responsible For Their Role in the Opioid Crisis

On November 23, 2021, A federal jury  found CVS, Walgreens, and Walmart were found guilty in fueling the opioid crisis in two Ohio counties. 

"It marks the first time the retail segment of the drug industry has been held accountable in the decades long opioid epidemic. The case could set a precedent for other U.S. cities and counties looking to take legal action against corporations for any role they may have played in the opioid crisis," according to this article.

This decision will be appealed, and has a good chance to be overturned according to this article. 

"The companies, who vowed to appeal, may not have to work hard to make their case, said Carl Tobias, a University of Richmond law professor who follows the litigation. Overturning the verdict could be justified by the decision of the judge overseeing the trial to not grant a mistrial, even after a juror admitted to doing Internet research about claims against the pharmacy operators, Tobias said. Jurors are only permitted to consider evidence and arguments presented in court."

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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.  

The Doctor Patient Forum

Claudia A. Merandi 5 Chedell Ave, E Providence, RI 029141.401.523.0426

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