#WAOpioidTrial Day 46 of WA v McKesson, et al begins at this link. Defense resumes their case today. BUT FIRST. Apparently the state changed up their plan for rebuttal witnesses. Judge wants to address it today before the weekend break. He is unthrilled?

#WAOpioidTrial So that is going to be interesting this afternoon! Just after the lunch break: discussing state's changed-up plans. Hmm.

Meanwhile: defense calls an IRL witness . . but before they get on the stand, state wants to argue about it. State's mad.
#WAOpioidTrial State just wanted to notify the judge that they plan to object to stuff this witness MAY say. Cool?

Defense calls Dr. James Hughes, economist. He's also testified at previous opioid trials.

So ... state should know what's coming?
bates.edu/faculty-expert…
#WAOpioidTrial Like here's an article from the WV trial, which briefly mentions his testimony.

State's arguing with defense (and the Judge) about whether Dr. Hughes' report is relevant and whatnot. Let's see what happens.

farrellfuller.com/headlines/defe…
#WAOpioidTrial So from what I'm gathering Dr. Hughes will testify about what insurers (payors) cover and how that impacts prescriptions, which impact pharmacies who order opioids, which impacts distributors who ship them.

State wanted it all OUT because . . it prolly hurts them?
#WAOpioidTrial State argued HARD to exclude this report . .. and the Judge overruled their objection.

Dr. Hughes will proceed. We start with lots of C.V. stuff to prove he's an expert. I'm getting a coffee refill.
#WAOpioidTrial Here's my guess, though: Dr. Hughes will state that payors stopped covering multi-modal care and therapies because it was more expensive, while generic opioids were CHEAP. Hence payor trends led to higher prescribing rates which led to bigger shipments of opioids.
#WAOpioidTrial Ironically, Dr. Hughes lists one of his 'Government Advisor' positions was at Brandeis.

Home to Andrew Kolodny, one of the nation's (world's?) biggest anti-opioid zealots.

I remain shocked that Brandeis allows Kolodny to destroy their brand like that. 🤷🏽‍♀️
#WAOpioidTrial State has objected like 5 times already in addition to their STANDING objection.
Judge: You may have a standing objection; objection is overruled. I think the scope of the abatement remedy sought by the state makes information such as this relevant to the case.
#WAOpioidTrial Then state's counsel objected 3 more times so far. Not even kidding.

The witness is testifying that when payors DO pay for prescriptions but DO NOT pay for alternatives .. doctors write more prescriptions.

Rocket science this is not. State doesn't like it.
#WAOpioidTrial Witness: Payors will seek to NOT pay for prescriptions which are not medically necessary.

Payors seek to NOT PAY FOR STUFF. And that's working out super-great for Americans. (<-- SARCASM)
#WAOpioidTrial After the 97th objection by state's counsel, the Judge responds:

"Counsel. I've given you a standing objection."

State's counsel: "I'm sorry."
#WAOpioidTrial And yet state's cousel cannot help themself: STILL MORE OBJECTIONS.

Judge: As the court has explained, the court's ruling stands; however this evidence is relevant to the state's abatement claim which is very broad in scope.

Yep. It IS very broad in scope.
#WAOpioidTrial Followed by:

State's counsel: 'I didn't mean to interrupt - I just wanna confirm that my standing objection is in effect.'

Judge: It is.

Cool cool cool. Listen, counsel - I don't know much about the law. But I THINK THE COURT IS AWARE OF YOUR OBJECTION.
#WAOpioidTrial Defense: How do prior auths impact opioid prescribing?

Witness: 1st makes the doctor reflect to ensure it's the best course of treatment
2nd: Insurer will review rationale; decide Y/N for coverage
Finally: A prior auth can lead doctors to avoid certain drugs.
#WAOpioidTherapy Oh boy, now we're talking step therapy!

Defense: What is it?
Witness: It requires the patient to try stuff which MAY work and fail at it before they get meds we KNOW will work. (paraphrasing)

Um. Unethical?
healthaffairs.org/doi/10.1377/hl…
#WAOpioidTrial Cont'd 'Step therapy quantity limits have been around since the dawn of managed care; initially used almost exclusively for cost containment. Patients have to be initiated & fail on a cheaper therapy before allowed to be RX'd a more expensive course of treatment'
#WAOpioidTrial Ironically there are some who believe that step therapy results in MORE costs than if doctors were able to prescribe what THEY think patients need. Aside from: leaving patients undertreated for any number of conditions while 'failing first'

capitolweekly.net/step-therapy-h…
#WAOpioidTrial Defense: Did you see any indication that the state of WA told the defendants they were shipping too many opioids to meet the medical needs of WA citizens based on the data they had available?

<objections, etc.>

Witness: I did not.
#WAOpioidTrial Defense: Did you see any instance where the state of WA told the defendants not to ship opioids to specific pharmacies that were outliers in the payer data?

<objections, etc.>

Witness: I did not.
#WAOpioidTrial From here the defense went on to ask about definitions for 'standard of care' and 'medical necessity' and various local policy/regulations, like L&I and Washington Administrative Code references.

(I skipped around) Skipping back to ... what AMDG said in 2007.
#WAOpioidTrial Defense: Have you seen statements from the state of WA encouraging doctors to consider treatments other than opioids to treat pain?

Brings up the AMDG 2007 GL, which say to consider opioids only AFTER other conservative measures have failed. Hold for list.
#WAOpioidTrial So there's a person with some kind of pain, and the AMDG says first they gotta try:

- NSAIDs
- Tricyclic antidepressants
- antiepileptics
- non-pharmacologic therapies

Then MAYBE try opioids. How's that patient doing, by the way? They weren't depressed before..
#WAOpioidTrial For non-pharma therapies they meant (back then): physical therapy, chiropractic care, acupuncture.

Today? That list is FAR more colorful. Whimsical. NON-EVIDENCE BASED. 👀

I'll circle back later. I have feels about this.
#WAOpioidTrial Defense: What did the literature show with respect to whether payers covered alternative pain treatments?

Witness: Coverage for these treatments is relatively sparse but it is also highly variable and there's not really any consistency across states.

Facts.
#WAOpioidTrial Defense: Do you have an understanding as an economist about why payers imposed coverage restrictions on alternative treatments?

<objections, etc.>

Witness: Primarily because the nonpharmacological treatments are thought to be more expensive.

Yep.
#WAOpioidTrial Defense calls out this sentence:

"Managed care organizations, recognizing that opioids
were less expensive than the comprehensive pain management clinics that once existed at many medical centers, stopped reimbursement for those services.

acpjournals.org/doi/abs/10.732…
#WAOpioidTrial 'Despite a growing evidence base supporting the effectiveness and cost-effectiveness of many of the nonpharmacological treatments examined in our study our findings depict inconsistent and often absent coverage for many of these treatments.'
jamanetwork.com/journals/jaman…
#WAOpioidTrial Defense: Are you aware of distributors playing any role in a payers' decision about whether or how much to cover alternative pain treatments?

Witness: No, I'm not.
#WAOpioidTrial From that same JAMA piece above:

"Insurers are increasingly recognized as influential stakeholders that are well positioned to drive changes in pain treatment practices. "

Defense: Do you see that?
Witness; I do.
#WAOpioidTrial Defense: Do you agree that insurers are well positioned to drive changes in pain treatment practices?

Witness: Yes I would agree. I believe that insurers have the info & they have the incentives & they have the tools to drive changes in pain treatment practices.
#WAOpioidTrial At this point Defense tendered the witness, the court took the mid-AM break.

State's counsel Ackerman began questioning the witness with:

'Mr. Hughes - I'm sorry is it doctor?'

DOCTOR Hughes: It's doctor.

Dude. Don't be an asshole. He's a PhD and you know it.
#WAOpioidTrial I'm sure some of the nation's top trial attorneys are assholes, for the record.

I remain NOT a fan.

Also amused at the Judge currently schooling Ackerman in real time. Heh.
#WAOpioidTrial I'm going to have try to catch up over the lunch break because WOW.

The Judge. Is not amused. (with Ackerman. State's counsel.)
#WAOpioidTrial How it's going for state's counsel:

Defense: Objection. Hearsay, Foundation, and Scope.

Judge: Sustained.

State: (sigh)
#WAOpioidTrial IT IS UNBELIEVABLE YOU GUYS.

Like I can't go back and do the 'what happened next' because the real time stuff IS SO COMPELLING.

By which I mean: it's like seeing a fight break out and you can't look away.
#WAOpioidTrial TO SUM UP. Where are we? What am I doing here?

State finished cross, defense finished redirect, & state tried re-cross. It was an EPIC FAIL. I can't wait to share deets over lunch.

Dr. Hughes (who did great btw) is done; defense returns to
#WAOpioidTrial There's going to be a delay in my trial coverage this afternoon due to what I can only refer to as: a clown-car level of cats.

Note: I do not own any cats. Hence. It's a thing.

Court is adjourned for the lunch break, I may or may not be back this afternoon!
#WAOpioidTrial Day 46 continues this afternoon at this link. It actually started ~20 mins ago.

State was supposed to file deets about their rebuttal case by noon, but didn't. Judge & defense got them at 12:37 and he is NOT PLEASED. Discussions ensue.

#WAOpioidTrial We're still arguing about how the court MAY handle rebuttal after the defense rests their case.

State wisely has someone NOT Ackerman negotiating on their behalf. It's Counselor Linda Singer, also of Motley Rice.

She hasn't ticked off the judge repeatedly.
#WAOpioidTrial Inexplicably, STILL arguing! Apparently parties all agreed to hash out a bunch of details before the trial adjourns for the weekend.

We're like .. nearly an hour in, still debating. I really need a lawyer to explain WTF is going on here. Seems .. . IMPORTANT.🤔
#WAOpioidTrial Okay here's what I *think* has happened. State has determined - LATE - that they want to call their witness former DEA guy Joseph Rannazzisi as a rebuttal witness. He was NOT on their rebuttal list. Previously because he was 'not available to testify'.
#WAOpioidTrial Joseph Rannazzisi's testimony came in earlier in recorded video deposition ONLY. Now state wants him here live, in person. Defense does not. Defense also argues there was nothing in their case needing him to rebut. LOTS of discussion back and forth.
#WAOpioidTrial We learn: 1) Rannazzisi is beyond the state's subpoena power; they can't force him to appear. 2) He's got some health issues so they thought he wouldn't be available. Hence defense couldn't cross IRL.

Suddenly to make state's case now in rebuttal? He's available.
#WAOpioidTrial Defense astutely points out: they couldn't inquire because Rannazzisi wasn't available, but now HOW TIMELY is it that he's available for the state's rebuttal?

Uh huh.
#WAOpioidTrial Anyway after an hour or so of debate (and far more nuanced legal argument than I comprehend or can convey):

JUDGE SAYS HE OUT. State may NOT call Rannazzisi as a live rebuttal witness.

Just when I finally learned to spell his name correctly. Derp.
#WAOpioidTrial That's a pretty big decision. Seems like a momentous development for the defendants. 🤔

Next: state wants to recall former DEA Ruth Carter as a rebuttal witness. Discussion ongoing.
#WAOpioidTrial The Judge has to decide whether her prior testimony - and the defense's case since - warrants bringing her back to REBUT something defense elicted. Something NEW the court has not already heard.

I don't think the Judge is going to go for it. But we'll see.
#WAOpioidTrial CORRECT. The Judge is granting the motion to exclude Ruth Carter as a rebuttal witness. Because the two issues state intended to raise were already covered - WELL covered - with her 40-ish hours on the stand the first time.

Dang, folks. 0 for 2 for state.
#WAOpioidTrial Next up: The state would like to call as a rebuttal witness a document custodian from the Washington Medical Commission to allegedly rebut testimony from Drs. Gilligan and Hughes which said "most prescribers operated in good faith." Um. So did the DEA say that.
#WAOpioidTrial Defense is arguing state could have had that in their primary case from the start, and right now they are trying to DUMP a ton of disciplinary records in last minute which defense would not have time to investigate or rebut. They also argue: LATE disclosure.
#WAOpioidTrial Literally State disclosed stuff Monday night (as required by the court) and THIS witness and these documents were not in it. Defense argues that nothing was disclosed in court Tues or Wed which makes this newly relevant.

I don't think .. this will go well. Again.
#WAOpioidTrial Once again: The Judge grants the defense motion to EXCLUDE their desired rebuttal witness.

Dang folks. 0 for 3 for state's requested rebuttal witnesses.

👀
#WAOpioidTrial Next up: State wants to call someone by video deposition from the Northwest High Intensity Drug Trafficking program to 'introduce documents' to rebut testimony by Dr. Gilligan and one of the defense execs on 'medicine cabinet diversion' and legitimate prescribing.
#WAOpioidTrial Aaaand the Judge said nope to this one too.

State could have offered this witness and this evidence in their original case because NONE OF THIS IS NEW.

State is 0 for 4. And we took the mid-PM break.
#WAOpioidTrial We're back, and state requests their last rebuttal witness (#5), an exec from McKesson who handled regulatory affairs, to rebut testimony from witness Boggs.

Let's see.
#WAOpioidTrial Once again the Judge points out that nothing the witness would address is NEW. It was covered already.

Judge gave a 101-level summary of the purpose of a rebuttal witness. Which none of these met.

He rules once again to grant the motion to exclude. That's 100%.
#WAOpioidTrial After a bit of discussion about Monday's schedule, we resume the video deposition of Pharmacist Heinz from earlier.

But WOW. That was an eventful 2 hours!
#WAOpioidTrial Pharmacist Kirk is talking about liquid morphine, regularly given to hospice patients. He's available 24x7 to local hospice nurses to dispense liquid morphine for these patients.

Um. My sister died of a primary brain tumor many years ago. That liquid morphine ..
#WAOpioidTrial That liquid morphine was a gamechanger. It allowed her to be comfortable in that last week of her life. And my family was trusted to dispense and dispose of it as needed, which we did.

NO ONE should suffer in undertreated agony. Not in hospice; not EVER. 😠
#WAOpioidTrial And defense wraps up their video depo, and court is adjourned today at 3:30pm. Until Monday at 9AM PT!

I'm going to take a little break here and then circle back to my notes from earlier when Ackerman made the judge lose his cool. Mwahahahah. Please standby.

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More from @funchefchick

Mar 23
#WAOpioidTrial Day 45 of State of WA v McKesson, et al is beginning at this link for the AM session. Note that this is the last day of the trial week; no trial on Fridays. Next scheduled trial date is Monday, 3/28/2022 at 9am.

Defense resumes this AM.

#WAOpioidTrial Current housekeeping measure under discussion about how to recall DEA's Rannazzisi - state intends to recall him via Zoom to rebut, but no one seems clear on that. Defense is predicting wrapping up their case Monday or Tuesday . . maybe.
#WAOpioidTrial It's complicated because there are THREE defendants here - much of their case is similar/unified, but there are specifics for each company which take time. Timing and estimates for how long witnesses and depos will take .. it's complex.
Read 73 tweets
Mar 21
#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.
Read 94 tweets
Feb 17
Historical data about annual prescription opioid overdose deaths in the United States has been wildly inaccurate for every year reported prior to 2018, and everything you've read about the cause of the 'overdose crisis' before then is wrong and bad: a thread. With sources. 1/20
First: Long before illicit fentanyl and the 'overprescribing of opioids' in this country, we had heroin as the primary related opioid in misuse/overdose deaths. Heroin deaths were often reported -inaccurately- as generic morphine fatalities or 'RX opioid deaths' nationwide. 2/20
Why? Because heroin rapidly metabolizes to morphine post-mortem. Standard toxicology screens reported many heroin overdose deaths as 'morphine' when really, they were undercounting heroin fatalities. 3/20 ncbi.nlm.nih.gov/pmc/articles/P…
Read 20 tweets
Feb 10
#WAOpioidTrial Day 29 is starting at this link.

OH HEY did anyone else notice that the CDC released their draft of their REVISED opioid prescribing guidelines this morning? BECAUSE THEY DID.

Any impact on the trial? Dunno.

painnewsnetwork.org/stories/2022/2…

#WAOpioidTrial Aaaand after some housekeeping measures, McKesson's defense counsel resumes their cross of Dr. Caleb Alexander ... . PROP affiliate. Good times, good times.
#WAOpioidTrial McK: In your report you said 'rogue MDs and 'doctor-shoppers' account for only a small amount of harms, right?

Dr. A: <long meandering paragraph which doesn't answer the question>

Courtroom: 🙄
Read 56 tweets
Feb 9
#WAOpioidTrial Day 28 beginning. Random thought: Are bench trials far more stressful for judges than jury trials? In a jury trial judge has to make sure the jury hears appropriate/admissible evidence, then jury decides. Bench must do same AND then rule.?

#WAOpioidTrial Regardless, we resume with the state of WA and their witness Dr. Caleb Alexander . .. notoriously PROP-affiliated, anti-opioid, 'everyone using opioids for pain is at risk of addiction' doctor who is here with a plan to 'abate' the epidemic in WA. Sigh.
#WAOpioidTrial To be clear: people in the know in WA are reasonable and appropriate. The Washington Medical Commission. The WA Dept. of Health. Assorted agencies. They recognize that people in pain deserve individualized care and that providers should be protected/encouraged.
Read 47 tweets
Feb 8
#WAOpioidTrial Day 27 is starting at this thread. Yesterday's trial day ended w/Dr. Jakki Mohr, Marketing expert/professor/Doctorate/wizard somewhat defensively arguing about opioid manufacturing/distributing marketing practices. Cross by McKesson starts

#WAOpioidTrial McK: "All marketing activities you described were conducted for ALL products, not just opioids, correct? Many different products beyond opioids. We gotta fill pharmacy orders across all products, right?"

Mohr: Yes.
#WAOpioidTrial Dr. Mohr previously served as an expert in a case against Purdue by the state of Montana.

Interesting. McKesson is attempting to introduce the State of WA vs. Purdue lawsuit.

This suit. 🤔

agportal-s3bucket.s3.amazonaws.com/uploadedfiles/…
Read 62 tweets

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