Thread by @funchefchick

#WAOpioidTrial Day 43 of the state of WA v McKesson, et al resumes at this link this morning. The trial began Nov. 15, 2021 and the state rested their case on day 34 (3/1/2022) and then there were motions to dismiss and FASCINATING arguments each way.

#WAOpioidTrial Defense began presenting their case the afternoon of day 36, on March 8, 2022.

We resume defense's case this morning with a live witness Dr. Chris Gilligan, an anesthesiologist out of Boston. Looks like he testified in the WV trial wvgazettemail.com/news/health/do…

#WAOpioidTrial His opinions on treating pain with RX opioids: forthcoming.

So far we're defining 'categories of pain' based on duration:

Acute < six weeks
Chronic Cancer Pain
Chronic Non-Cancer Pain

PRO-TIP: The FDA has declared there is NO difference between those last two.

#WAOpioidTrial Cancer pain is not 'more virtuous' than non-Cancer pain. There's just no difference.

American Cancer Society has a very powerful lobby with tons of funding. Cancer pain is typically excluded from RX guidelines entirely.

Everything else? On the table. Sadly.

#WAOpioidTrial Defense is pulling up the "Relieving Pain in America" report from the Institute of Medicine from 2011:

ncbi.nlm.nih.gov/books/NBK91497/

#WAOpioidTrial You can download your own free copy of that report from this site (you have to create a free account first). Also defense is reviewing this data from page 28 of the report:

nap.edu/catalog/13172/…

#WAOpioidTrial Specifically:

People have severe pain post-op. And routinely develop chronic, continuingly pain. Yep.

#WAOpioidTrial Defense: For how long have RX opioids been a recognized treatment for pain?

Witness: Centuries.

D: For how long have their been recognized risks?

Witness: Since the Civil War? There was a significant problem with opioid addiction after that.

D: So then ..

#WAOpioidTrial Defense: So why do we still use RX opioids to this day?

Witness: There are many clinical circumstances - opioids are our most powerful pain med. There are many circumstances where you cannot grant a patient adequate pain relief with any non-opioid medication.

#WAOpioidTrial Defense witness: Some of the severe chronic non cancer pain conditions - it may well be impossible to get that patient adequate pain relief with anything short of an opioid.

#WAOpioidTrial Witness went on discuss the risks and benefits and efficacy of medications which are evaluated by the FDA prior to approval.

State moved to strike that testimony due to lack of foundation. Judge overruled the objection. As well as a few others.

#WAOpioidTrial State has objected to this line of questioning something like 7 times. All overruled. There was one sustained - defense counsel was reading a document, but instead they moved the whole document into evidence. Derp.

Judge appears to want to hear this witness.

#WAOpioidTrial Defense raises this 1982 editorial in NEJM.

You can find this very old editorial here: sci-hub.ee/10.1056/NEJM19…

#WAOpioidTrial Defense calls up 'Cancer Pain Relief' from 1986 by the WHO. Specifically: this ladder. What became known later as 'step therapy' if I'm not mistaken. Page 19 of that doc.

apps.who.int/iris/bitstream…

#WAOpioidTrial I'm trying to keep up! Defense is moving fast! He pulls up WA state CSA law from 1993, found online here.

Specifically, here:

lawfilesext.leg.wa.gov/biennium/1993-…

#WAOpioidTrial It took me forever to find this - the mid-AM break came at a fortuitous time - but this old MQAC statement from 1996. Check 1st and 3rd paragraphs particularly.

web.archive.org/web/2010020300…

#WAOpioidTrial THIS RIGHT HERE. This was the law in WA in 1996. Sigh.

#WAOpioidTrial Argh, I cannot find the original FSMB guidelines 1998 - but they were pretty great. I'll try to find them later. Comment here with an URL if you have it!

'Model Guidelines for the Use of Controlled Substances for the Treatment of Pain', May 1998 FSMB

#WAOpioidTrial We'll circle back to the FSMB, for sure - because they have consistently been EPICALLY GREAT about access to individualized care for pain. FSMB = Federation of State Medical Boards FYI.

fsmb.org/opioids/

#WAOpioidTrial The gist of all of this is: defense is illustrating with both WA state AND national/federal policies that the treatment of chronic, non-cancer pain has evolved over time. With policies over time and statements, etc. Standard of care evolved.

THERE IS A LOT HERE.

#WAOpioidTrial "Under generally accepted standards of medical practice opioids may be prescribed for the treatment of acute or chronic pain including chronic pain associated with cancer and other noncancer pain conditions."

WA State L&I, May 2000. Oh, the irony.

#WAOpioidTrial "A joint statement from 21 health organizations and the Drug Enforcement Administration. Promoting pain relief and preventing abuse of pain medications: a critical balancing act" - 2001.

DEA allegedly cared about pain care, then.

aspmn.org/documents/A_JO…

#WAOpioidTrial Now looking at the Joint Commission on Accreditation of Healthcare Organizations Pain Standards for 2001:

jointcommission.org/-/media/tjc/do…

#WAOpioidTrial Specifically RI 1.2.8: Standard: Patients have the right to appropriate assessment and management of pain.

Intent: Unrelieved pain has adverse physical & psychological effects. Patient's right to pain mgmt is respected & supported. Pain is recognized & addressed.

#WAOpioidTrial In 2004 the FSMB updated their statement. Specifically:

sci-hub.ee/10.1080/j354v1…

#WAOpioidTrial In 2006, DEA made this public statement. Most prescriptions were legit. Most prescribers are legit. Like - OVERWHELMINGLY SO.

And yet. Here we are. Sigh.

deadiversion.usdoj.gov/fed_regs/notic…

#WAOpioidTrial By the way the defense completed their timeline of "Changes of Standards of Care: 1980s-2000s" with a list evolving opioid policies and statements by state and federal licensing and regulatory groups. It was a lot, I missed a couple. 😮‍💨

#WAOpioidTrial Defense moved on to studies which revealed that people who received RX opioids often had unused pills which they kept in medicine cabinets. (SIDEBAR: INDICATING THAT THEY DID NOT MISUSE THEM OR BECOME ADDICTED. UNUSED PILLS MEANT THEY STOPPED TAKING THEM. RIGHT?!)

#WAOpioidTrial Anyways - witness says doctors tried to ensure their patients had the 'right amount' of pain relief, while ensuring they were not left in pain.

Those patients routinely did NOT become addicted, which was those provider's primary concern and responsibility.

#WAOpioidTrial Nearly always those unused pills were NOT misused by their patients; they were misused by others. 3rd parties who found/stole/bought them.

How could providers predict that people OTHER than their patients would take the pills the prescribed? They couldn't, then.

#WAOpioidTrial It became known over time that 'medicine cabinet diversion' was happening.

That became more widely known later. There are reasons while healthcare didn't adapt more quickly; I'll circle back when there's more time.

#WAOpioidTrial There was just a big kerfluffle when defense tried to move into evidence the AMDG Dental Guildeline on Opioid Prescribing. State was all mad about it. Judge overruled several objections.
amdg.wa.gov/Files/20171026…

#WAOpioidTrial This Guideline states: "Dentists write approximately 31% of opioid prescriptions for patients between 10 to 19 years" and "For example, an average of 52 opioid tablets are dispensed after tonsillectomy and an average of 44 tablets go unused." Then misused.

#WAOpioidTrial PERSONAL SIDEBAR: I got my tonsils out at age 16. I was inpatient due to my age. IT WAS HORRIFIC. I used my RX opioids for that week post-op, thank you very much.

DO NOT LET YOUR CHILDREN SUFFER FROM TONSILLECTOMY FOR THE LOVE OF ALL THAT IS HOLY.

#WAOpioidTrial Heh. Defense is bringing up ALL of the AMDG guidelines on prescribing opioids, this time the 'Guideline on Opioid Dosing for Chronic Non-Cancer Pain'.

AMDG: Has multiple PROP members involved.

#WAOpioidTrial In case it isn't clear who is behind the AMDG here in WA take a look at the 'other resources' page on their site. There are 5 YouTube videos there about opioid addiction and dependence.

ALL posted by Andrew Kolodny. Under the PROP banner.

amdg.wa.gov/OtherResources

#WAOpioidTrial In fact, that header says: "Physicians for Responsible Opioid Prescribing - The following educational materials are presented by the Physicians for Responsible Opioid Prescribing web site. Please visit <their site> for more information.

My tax dollars at work.

#WAOpioidTrial Literally the WA Dept of L&I put up that site and is listed as the contact info for anything about it.

And they are hosting content from the nation's biggest anti-opioid zealots.

Hello, ethics ombudsman? Media? Anyone?

#WAOpioidTrial ANYWAY. We're adjourned for lunch, thank the gods, because defense covered a TON of ground this morning. That was a nice overview of major policies/statements over that period. I need a nap. Or more coffee. Back at 1:30pm PT!

#WAOpioidTrial State of WA v McKesson, et al resumes day 43 at this link for the afternoon.

For my sake I'm hoping the defense goes at a slightly slower pace ... . .

👀

#WAOpioidTrial Defense continues to inquire with their IRL witness Dr. Chris Gilligan, and to illustrate the history of opioid prescribing for the treatment of pain over time. We're up to roughly 2007.

But state is objecting to the defense entering in a DOH letter from 2010.

#WAOpioidTrial Once again, state's objection is overruled.

The letter is from WA DOH to the Osteopath board, enclosing a copy of "Responsible Opioid Prescribing" written by Dr. Scott M. Fishman, with the support of the FSMB. A copy went to every licensed Osteopath in WA in 2010.

#WAOpioidTrial Excerpt from the Fishman book: "There is no debate among public health experts about the undertreatment of pain, which has been recognized as a public health crisis for decades." This was from 2010.

#WAOpioidTrial Now defense is discussing the 2010 update to the AMDG Guideline on Opioid Dosing for Chronic Non-Cancer Pain and various excerpts.

it is somewhat ironic that defense is using PROP's own (harmful to patients) GLs to fight against the #LitigationNarrative nonsense.

#WAOpioidTrial Defense is now raising WA ESHB 2876, which we talked about last week a bit. This law effectively ended the treatment of pain by primary care providers in WA.

Not overstating it. It ENDED pain care by PCPs. With too few pain specialists.🤬

https://twitter.com/funchefchick/status/1504149111343177737?s=20&t=7_5iqKoMN9giyUlRRzWeDQ

#WAOpioidTrial State is objecting to defense entering in ESHB 2876 because of 'lack of notice' or 'foundation'. It is literally part of the Washington Administrative Code and has been public and visible since 2009. But sure. THE STATE OF WASHINGTON (or the AG) IS BEFUDDLED BY IT.

#WAOpioidTrial Defense is portraying the 120MED limit in 2876 as a 'safeguard' for providers, and basically saying: doctors were still encouraged to prescribe opioids to their patients in pain where benefits outweighed risks. And 2876 codifies it, as well as specific concerns.

#WAOpioidTrial Defense enters in to evidence the FDA's letter to Andrew Kolodny/PROP mostly denying the PROP citizen's petition from Sept. 2013. State strenuously objects, and the judge . .. overrules the objection. But barely. It's tricky, legally.

paindr.com/wp-content/upl…

#WAOpioidTrial Whoops - state successfully argues (after the next question) that this letter introduces NEW testimony and it's legally complicated but the judge rules to sustain the objection, so that line of questioning ends there.

Defense moves on to 2015 revision of AMDG.

#WAOpioidTrial I'm sure you'll all be shocked to learn that the AMDG (made up of multiple PROP board members) determined that opioids for chronic pain - or "Chronic Opioid Analgesic Therapy", or COAT - is bad and wrong and you shouldn't do it. Because of course they did.

#WAOpioidTrial You'll start to notice the terms 'COT' or 'COAT' to describe RX opioids for pain around 2015. The term 'chronic' in medicine describes a DISEASE state, not a treatment or therapy.

If you see 'chronic opioid use' regarding RX for pain? That's a zealot.

#WAOpioidTrial Do you ever see in medical documentation 'chronic insulin use' or 'chronic ACE inhibitors use' or literally any other prescribed thing?

You do not. HHS used the phrase "Long-Term Opioid Therapy" or LTOT in 2019, although I'm not sure if that was the first use.

#WAOpioidTrial HHS published this "do NOT abandon or forcibly taper your pain patients unless they are in crisis, and not all patients need to taper" guideline in 2019. It's pretty decent.

hhs.gov/opioids/sites/…

#WAOpioidTrial Point being: After 2019 if ANYONE uses 'Chronic Opioid Therapy' or similar regarding RX opioids for pain?

They are showing you who they are. Believe them. (Hat tip to the beloved Ms. Maya Angelou for the brilliant guidance.)

brainyquote.com/quotes/maya_an…

#WAOpioidTrial At last! Our WA heroes, the Washington Medical Commision.

You guys. The WMC single-handedly prevented really terrible opioid prescribing laws in WA state in 2018. Truly. It's a long story - but trust me on this. We were very close to far worse tragedy here.

#WAOpioidTrial After the @WAMedCommission rescued our state opioid prescribing rules late in the drafting stage (whew!) they later released these interpretive statements about them. First, to medical providers:

wmc.wa.gov/sites/default/…

#WAOpioidTrial Followed by a similar statement by @WAMedCommission aimed at PATIENTS, to help them to understand what the new rules meant for them. What providers were allowed to do to treat them, still. 🙏🏽

wmc.wa.gov/sites/default/…

#WAOpioidTrial My belief is that WMC was trying to ensure that providers CLEARLY understood the new prescribing rules. And that patients did too so that if a provider said "the state law says I cannot prescribe opioids to you any longer", a patient would know: that's not true.

#WAOpioidTrial No medical provider MUST treat a patient with opioids, obviously. A provider can have any number of legitimate reasons to discontinue opioid therapy for a patient.

The key point here is: 'the state law says I cannot' is NOT on that list of legit reasons.

#WAOpioidTrial While I was fangirling the WMC just then, the state objected to the defense entering in to evidence. .. the 2016 CDC Opioid Prescribing Guidelines.

⁉️

#WAOpioidTrial Subsequently, defense entered in a bunch of stuff authored by or mentioning Gary Franklin, here in WA. He's the medical director of Labor & Industries here (and has been since 1988), on staff at U. Washington, and .. VP of PROP. Also chair of AMDG. Ahem.

#WAOpioidTrial First, a letter on AMDG letterhead from Franklin to the Governor of Puerto Rico about drug decriminalization. I'll have to see if I can find it online anywhere, because ?!! Second: This article from 2014 which Franklin co-authored.

doh.wa.gov/sites/default/…

#WAOpioidTrial Of note in particular from that document:

Defense: Do you recognize this statement as accurate? Witness: I do.

Defense: Do you see that attributed in this article in any way to distributors?
Witness: No, I do not.

Yep. You sure don't. 🤔

#WAOpioidTrial Followed by this box from the 5th page of that article.

Defense counsel: In this box do you see any of these elements focused on distributors?

Witness: No.

Because NOWHERE in any of the state opioid strategies (to my knowledge) is: restrain DISTRIBUTORS. 🤷🏽‍♀️

#WAOpioidTrial That was the end of the direct questioning by defense counsel of Dr. Gilligan and then we took the mid-PM break.

State's counsel is now up on cross of Dr. Gilligan. Let's see how they do.

He stated FACTS backed up with sources, so. Yeah. What you gonna do?

#WAOpioidTrial Ha! Right out of the gate the state tries to ask the witness about the "Economic costs of the opioid crisis' when he literally said nothing about any of that on direct, which means state cannot ask.

Judge sustains defense's objection pretty quick.

#WAOpioidTrial Aaand now they are asking about the "Underestimated Cost of the Opioid Crisis" by the "Council of Economic Advisers" aaaand I'm puzzled why there isn't an objection yet since he doesn't know who they are or what this is.

#WAOpioidTrial State (on cross) to the witness: "have you reviewed any due diligence documents in preparation for this trial"

Uh, no. He's testifying prescribers and pain care policy over time, and how it evolved. He is not an expert on suspicious orders or whatnot.

#WAOpioidTrial His point is: prescribers have medical history & patient relationships & are best equipped to determine what is appropriate for pain care/opioid prescribing. And that manufacturers & distributors DO NOT HAVE THAT INFORMATION. So they are not equipped to assess.

#WAOpioidTrial State's strategy here seems to be asking the witness about all of the things he did NOT study or review unrelated to his expertise. As if that somehow gives less weight to his extensive knowledge on the treatment of pain in the United States over time.

#WAOpioidTrial State is diving in to the first item on defense's "Changes of Standards of Care" timeline, the 1982 NEJM editorial from this morning. She pulled out a few sentences from it . ..none of them compelling? Not sure what the point was there.

https://twitter.com/funchefchick/status/1505956655892107265?s=20&t=7_5iqKoMN9giyUlRRzWeDQ

#WAOpioidTrial First, state pulls up a slide of the "Changes of Standards of Care" which defense quickly notes is NOT the same image they'd presented. Odd.

Then state pulls up THIS diagram instead of the LADDER defense used from the WHO Cancer doc.

https://twitter.com/funchefchick/status/1505958509199826946?s=20&t=7_5iqKoMN9giyUlRRzWeDQ

#WAOpioidTrial State seems to be using different pages of the exhibits or different version of them . . . to confuse things? But why? 🤔

#WAOpioidTrial Now state returns to the LADDER diagram.

Earlier she asked the witness: this CANCER document doesn't mention non-cancer pain, right?

Well, no. It was a cancer-focused document. Witness says that subsequent revisions DID include Chronic, Non-Cancer Pain. Obvs.

#WAOpioidTrial State just asked the witness "what does the top step of the ladder diagram, box 3, read?"

Witness: It reads "Freedom from Cancer Pain."

Like .. voila? It is a CANCER PAIN document. That does not mean WHO intentionally excluded non-cancer pain. Back in 1986!🤦🏽‍♀️

#WAOpioidTrial State is going through each policy or statement on the timeline to try to spin or twist them - like the JCAHO Pain Standards from 2001. State points out they don't specifically say 'use opioids'; they say 'appropriately recognize and treat pain'.

Sigh. 🤦🏽‍♀️

#WAOpioidTrial So help me, I'd like to think that JCAHO in 1986 believed that when doctors heard "treat pain appropriately" providers would understand that to mean "using opioids when appropriate or necessary, and NOT using them when not appropriate or unnecessary." Right?!

#WAOpioidTrial State then tries to move into evidence this report. Defense objects. Witness has not seen this document. I don't think we'll get very far with this? Let's see.

gao.gov/products/gao-0…

#WAOpioidTrial Defense objects on scope, lack of foundation.

Judge sustains. State backtracks and says "So you DIDN'T use this report to frame your opinion?!"

Witness: Uh, no.

#WAOpioidTrial State: Information about the diversion of a drug - like in this report - is something a provider should be aware of, yes?

Witness: Yes, it would.

#WAOpioidTrial Another PROP member has entered the chat. The infamous Ballantyne editorial in NEJM which caused Tauben's epiphany (as described last week) is introduced by state on cross.

https://twitter.com/funchefchick/status/1504171499736895493?s=20&t=7_5iqKoMN9giyUlRRzWeDQ

sci-hub.ee/10.1056/NEJMra…

#WAOpioidTrial Attn: @AGOWA When your arguments rely primarily on editorial comments & data from PROP you have a serious bias problem.

Also you are disregarding the 20% of the state who are disabled, many of whom have incurable pain conditions. Ableism. Maybe you've heard of it?

@AGOWA #WAOpioidTrial State's now bringing up the Fishman book. It says, among other things: 'Yet these same life-restoring medications carry the potential to do grave harm to patients who may be at risk for addiction and abuse. '

Correct. Cont'd -

https://twitter.com/funchefchick/status/1506006784628060160?s=20&t=7_5iqKoMN9giyUlRRzWeDQ

@AGOWA #WAOpioidTrial Two things: First, ANY legit guidance about treating pain/using opioid includes this guidance, because there is ALWAYS a non-zero chance that a patient could develop OUD. Facts.

But second: Prevalence rate of OUD in USA? 0.37% in adults over 18. Non-zero. Low.

@AGOWA #WAOpioidTrial For crystal clarity: According to the DSM-V, the rate of opioid use disorder among adults in the USA over 18 who are not incarcerated is: 0.37%.

Citation: Page 543 of the DSM-V. repository.poltekkes-kaltim.ac.id/657/1/Diagnost…

@AGOWA #WAOpioidTrial I include this to say: if state's argument is "AHA prescription opioids can cause harm!" well, yes. Correct. Like ANY medication (or substance) on earth, when used inappropriately RX opioids can cause harm.

But statistically? Mostly, they DO NOT.

@AGOWA #WAOpioidTrial Less than 1% of adults develop an addiction to opioids - of ALL kinds - and more than 90% of people prescribed opioids do not develop an addiction to them.

The rates are low and remained flat for generations. What's changed is lethality of substance. And deaths.

#WAOpioidTrial The data is all there. This is the rate of 'pain reliever misuse'; a category they only started measuring in 2002. In 2002 it was 0.6%. In 2014 it was 0.7%. I'm not making up these numbers, folks. Look for table S2.
samhsa.gov/data/sites/def…

#WAOpioidTrial It is not my intent to downplay the severity and importance of preventing and treating substance use disorders - we absolutely need BETTER access to effective care.

But anyone who thinks we can solve those complex issues my limited RX opioids? Is sadly mistaken.

#WAOpioidTrial The American public was sold a story: RX opioids caused this crisis, and if we target our efforts at decreasing prescribing of opioids, it will all be solved.

And billions were spent on those efforts. Instead of solving the 'crisis' things got so very much worse.

#WAOpioidTrial Now my state AG - instead of focusing on illicit substances which are literal poison - is continuing this nonsense #LitigationNarrative which harms providers and real, suffering pain patients. And does not help those with SUDs one bit.

We're tired and we're angry.

#WAOpioidTrial Our friends and families, our brothers and sisters: they ALL deserve individualized care whether it is for addiction or for pain (of all kinds). Our providers should not fear being persecuted like cartel members for practicing medicine and trying to treat our pain.

#WAOpioidTrial Before I wrap up:

Disabled people VOTE. So do the friends & family who love us. And we remember.

This dismissive, reductive nonsense which continues to deprive MILLIONS of us of pain care and harms our providers? We will remember.

#CriptheVote #DisabledRights

#WAOpioidTrial That's it for State of WA v. McKesson, et al day 43. I think tomorrow is a short day because of a meeting the Judge has, but we'll sort it later. See you tomorrow at 9am PT! Oh yeah - THE TRIAL MANTRA. Feels timely. Ciao!

https://twitter.com/funchefchick/status/1489010210890944513