Thread by @funchefchick

#WAOpioidTrial Day 13 has begun! We open this morning with state re-arguing some objections which did not go their way last week on foundation. Let's watch and see how this goes. The three prongs (apparently) are:

Authentic
Relevant
Admissible

Judge Scott has retiterated many times - and pretty much begged state to stop saying - it's not about authenticity, it's about foundation & relevance. Literally Judge said "please stop saying authenticity" AND THEN STATE SAID IT AGAIN and the Judge literally put a "wait" hand up.

Literally state is continuing to stay AUTHENTIC - it had the company's logo on it on every page .. .. .

While IANAL . .. I think the judge is going to maintain his earlier rulings on the series of objections from last week. Interesting stuff.

Cardinal's counsel asserts that the WV judge ruled authenticity does not equal admissibility. State jumps in to say HEY THAT WAS NOT WA and we're special. The judge - somewhat angrily - replied: really?! Because WA's rules are very similar to federal, so it IS relevant.

In fact, judge said: I WILL CONSIDER IT, in fact, because reasons.

And then someone noticed there was a witness in the galley, whoops, so they stepped out while the discussion continues.

An Assistant US Attorney (from WA's federal office) is observing the trial ... interesting.

State calls former DEA unit chief Ruth Carter, a 31-year vet of the DEA; now a consultant. Her name appears online in various places, like this slide deck. Note: data in this deck is INACCURATE. Fentanyl-related deaths were reported as RX in 2012.

deadiversion.usdoj.gov/mtgs/pharm_awa…

Lots of time spent on foundation for the witness, etc. etc. And then . .. she says distributors (defendants) screwed up because they 'relied on artificially high thresholds'; 'Thresholds too high: set at epidemic levels and then increased by multiplier'. What ?

LITERALLY she means: they set ordering thresholds during what DEA called the 'epidemic', so therefore they were too high. (?)

ONLY. We now know - although DEA still fails to recognize - that MOST of the overdose/drug poisoning crisis was due to illicit drugs and polypharma.

I will continue to balk at statements which allege that prescriptions dispensed under DEA oversight nationwide were 'too high' when zero context is provided about those prescriptions, who they were for, what the painful diagnosis was, whether there was a history of misuse, etc.

Now the witness is grumbling about suspicious orders which were reported but distributors still shipped - WHICH IS WHAT THE REGS TOLD THEM TO DO. Or that no suspicious orders were reported prior to 2007 ... which is when the regs started requiring it. Sigh.

Witness: "Distributors had their own sales and dispensing data; they should have been able to look at it in any number of ways and determine things". Which would have been over and above the federal regulations? Are we holding the distributors to a higher standard than fed law?

'One thing which is effective against diversion is looking at red flags. They should have looked at red flags."

So 'red flags' are clearly defined and visible and all they had to do was look ?

Ugh let's talk about the 'holy trinity' of street drugs: opioid, anxiety med, muscle relaxant. Widely known as a lethal combination if people take them all together.

Do you know who else occasionally takes this combination of meds? People with severe, intractable chronic pain.

Literally people with inflammatory conditions? Need muscle relaxants to relax. Pain meds to make pain levels tolerable. And sometimes - anti-anxiety meds if they also suffer from anxiety. This combination has legitimately been taken for decades, by millions.

And yes - some have taken all three in very high doses and it CAN be deadly or dangerous - suppresses respiration and heart rate, etc.

Should no one now ever take them (under direct medical oversight) because a very VERY small percentage misuse them?

DEA Witness: "Oxycodone 10mg and above is VERY high dose and is preferred by drug abusers and drug seekers."

How charming. And wildly inaccurate. 🤦‍♀️

Witness is saying that distributors should have recognized when pharmacies were getting medications from competitors - other distributors - and considered it a red flag. How ? Pharmacies might have volunteered it. BUT DEA WOULD NOT INFORM THEM even though they knew.

Earlier in Rannizzissi's testimony he stated that DEA would not share competitor data w/distributors - they couldn't, by law. That law has now been changed so they CAN share it.

But this witness is saying they SHOULD HAVE KNOWN somehow when pharmacies ordered from multiple dist?

We are looking at an internal email from Cardinal's then-counsel (?) commenting on a news headline about an "oxycodone ring" & his thoughts about how it might be relevant to Cardinal - there's no smoking gun or red flag here, just someone conveying thoughts. Somehow admissible?

Literally someone said inside their corp email: "If this had involved us, here are what my concerns would be, and something for us to think about."

DEA: It's evidence that they were not conducting sufficient diversion control.

Really? Not how I see it.

DEA has classified McKesson's anti-diversion work into three eras - pre-2007, May 2007-May 2008, and post. To repeat: the DEA regulations changed over time.

Which - since DEA completely missed the boat on illicit fentanyl that whole time, they would have scrambled to amend.

"Were the (defendants) order monitoring procedures as stringent or careful PRIOR TO 2007 than they were later? No?"

Um. I think we can all agree that in general most of the country became aware of non-medical use AFTER the early 2000s. Meanwhile THEY STILL HAD TO SHIP MEDS.

It wasn't like these distributors could stop everything and design an elegant, effective monitoring system which did not obstruct shipping medications with the luxury of time. They had to comply with federal regs, ramp up monitoring, AND constantly ship medications non-stop.

Would DEA have preferred that people suffering traumas, recovering from surgeries, battling cancers, surviving incurable/disabling pain conditions just wait it out in agony?

Oh wait. Yes. They would.

ascopubs.org/doi/pdf/10.120…

Ugh. Once again: someone in distributor's sales group says: hey if we could warn a customer when they hit 85% of their max threshold in orders, we could help them work on a threshold increase before they hit it/we lose sales.

Pretty standard sales stuff. DEA says VERY CONCERNING

REPEATING FOR THOSE IN THE BACK: Pharmacies fill those meds for cancer patients, surgical patients, trauma victims, people disabled by incurable/intractable pain.

DEA is VERY CONCERNED there might be more orders for pain meds to help them. So they just said on the stand.

AND before I forget - the medications used to help those struggling with opioid use disorders? Medication-Assisted Treatment? Those are also opioids. DEA DOES NOT DIFFERENTIATE. So these reports of opioids sales and DEA concerns? INCLUDES MAT MEDS like Methadone, Buprenorphine.

La la la ... we are still watching state ask the DEA witness about the order/sales/dispensing thresholds..

There are real human people in pain behind those orders and those thresholds. DEA Witness (and the prior DEA witness) seem to NOT acknowledge that. Real people; real pain.

Now reviewing an internal McKesson email from 2011 where someone raises a concern about a potential gap in diversion oversight - so the company's attempt to do due diligence and improve is now being used against them in court ... meanwhile ALL of this was under DEA's oversight.

DEA witness has repeatedly said the order thresholds were artificially high because they were determined 'at the height of the epidemic'. By which she meant the 'opioid epidemic', a term DEA created.

It was never considered how many real people were in pain; then OR now.

I just. We were shown an email where McKesson's Director of Regulatory Affairs said "vague generic reasons for justifying threshold increases are not allowed; you need to be very specific with legitimate justifications, like <examples>". Right. Good. WHY IS THIS BAD?!

Wouldn't that indicate that they were denying threshold increase requests if they were not appropriately justified? Which is what the DEA wanted to happen?

Not one pill was dispensed without a DEA-licensed pharmacy with a DEA-licensed MD/ARNP writing an RX. WHY ARE WE HERE.

Now we are looking at a threshold increase request of METHADONE which DEA doesn't like. Methadone is most commonly used for MAT.

The DEA apparently does not approve of increases of MAT medications. As well as pain medications.

Cool cool cool.

Looking at what appears to be a very fast approval of a threshold increase . ... from 2010.

Ordered by a DEA-licensed pharmacy. Apparently the distributors are supposed to be gatekeepers of all the pharmacies nationwide, as opposed to the PHARMACIES being responsible?! What the?

FFS. The "warn someone at 85% of their threshold" is 'not good diversion control'.

Again. Real people with prescriptions were behind those 'order thresholds'. The discussion is just 'thresholds" as if they were arbitrary.

Real prescriptions existed/needed filling.

And right before the court adjourned for lunch, we were seeing emails from overworked folks trying to keep up with threshold increase requests, of which there were apparently many.

Which - legit, there was some suspicious stuff going on back then. So yeah. But ...

Per the head of DEA Diversion team (RAN): 99% of prescribers were doing the right thing. Which means the overwhelming majority of prescriptions written were legit.

Yet we've spent TONS of time/effort on this tiny fraction when the overwhelming cause of OD was fentanyl. NOT RX.

We DO need more funding for SUDs treatment. We also need 10x more funding/resources for PAIN TREATMENT. The United States sacrificed pain care and abandoned people with pain to focus on . .. the WRONG target in the overdose crisis. It helped neither; harmed or killed MANY.

The "prescriptions caused the overdose crisis' theory has become an archaic remnant; tons of data now prove what many have known: the War on Drugs/Drug Prohibition is terribly wrong and results in casualties, substandard medicine. Back after lunch!
inquirer.com/opinion/commen…

#WAOpioidTrial has resumed for the afternoon. After a quick discussion about the previous authenticity/admissibility objections, state resumes their case with state's witness Ruth Carter, formerly of the DEA.

Good times.

To be clear: State's argument overall is that the 3 biggest pharmaceutical distributors in the country caused a 'public nuisance' by shipping 'too many' opioid pills into pharmacies in WA state. We are spending a lot of time right now on ... .

Pharmacies in WA which regularly ordered opioids (and other meds) from distributors and some would ask to increase the amount they could order regularly.

Not one pill was dispensed w/o an RX from a DEA-licensed prescriber, by a DEA-licensed pharmacy. 🤷‍♀️

Even if the distributors somehow failed in their duty to meticulously track these patterns of orders going back 20 years then they'd be guilty at most of a regulatory infraction. It is ridiculous to hold the distributors responsible for people using meth & illicit fentanyl today.

DEA Witness: "If pharmacies were purchasing above the statewide average, that would be another red flag."

Um. Wouldn't that be . . oh .. . like half of the pharmacies in the state because MATHs? Half would be above the average, half would be below the average? Ish?

🤦‍♀️😬

We are looking at graphs and charts of various WA pharmacies' purchases of specific drug/dosages (which the pharmacy requested/sold, but is somehow the distributors' responsibility?!).

Once again: good thing this isn't a jury trial. Yawn.

State: "We'd like to enter into evidence number <xyz>"

Oh boy! Another email from 2008! Super.

Funny. Now seeing a dot matrix printout (Kids! Ask your folks!) of a Cardinal report from 2005. Earlier in the trial, state's super brainy data consultant testified - if memory serves - that some data was excluded from analysis because "dot matrix was too fuzzy to read". !

By which she meant - it was a hard copy print out - made LOUDLY and VERY SLOWLY by an old-school printer, so it wasn't something she could scan. NOT DIGITAL.

And this is how it used to sound to PRINT STUFF before laser and inkjets were a thing.

Interesting objection about admissibility of an internal email which the witness is reading aloud . . . there's been a handful of these 'document isn't admissible, but having the witness read it aloud into the record IS" objections .... again, I wish a lawyer could explain these!

So the same few local WA pharmacies keep being named in this trial repeatedly as evidence of lack of oversight by these distributors. This small handful were clearly the outliers in WA state. But - they are also still all licensed by DEA and WA state, and STILL OPERATING TODAY.🤷‍♀️

State's witness (still former DEA Ruth Carter) has been excused from the courtroom while the judge and the parties argue about some kind of admissibility or something. Between video depos, emails people did or didn't see, laywitnesses and expert witnesses ... it's complicated.!

And we're back. I *think* the state prevailed with those objections being overruled ... .but ask a lawyer to know for sure. !

Yep, we're focusing on this ONE allegedly sketchy pharmacy between 2006-2007. They ordered WAY more Hydrocodone 10mg pills in 2007 than they did in 2006, and far more than the state average. So . .. that's indeed a case of a DEA-licensed pharmacy doing something odd.

So should the DEA have conducted an investigation into this pharmacy, maybe? For sure.

OH WAIT. The DEA and the distributor apparently shut them down on the same day. They were filling internet scripts before that was made illegal. So .. . yeah. The law caught up.

If I'm not mistaken ... DEA witness just described "pharmacy ordering opioids within their threshold every month, but just barely under" (so NOT asking to increase threshold) would eventually get their threshold increased. They called it "threshold creep".

So now NOT asking to wildly increase their order threshold - but literally using the amount they legit ordered/dispensed OVER A YEAR'S TIME due to their local region/patient needs to justify a quantity increase - THAT is somehow nefarious?? Really?!

Breaking news - DEA witness discovered that sales people were paid commissions and bonuses based on reaching sales volume/targets (based on all drugs, including opioids).

FILM AT 11.

(Also .. . as we determined in week 1 of trial: HOW SALES WORKS.)

https://twitter.com/funchefchick/status/1461129324547821571?s=20

Aaaand we have reached the end of trial day 13. I missed the end because I paused the stream to look up something and POOF. When court adjourns that stream goes offline and I mean instantly.

Tune in tomorrow for day 14! Reminder no trial scheduled after 12/16 until 2022. Ciao!